WELCOME TO THE ECHO NIH RETURN
TO INDIVIDUAL RESEARCH RESULTS
TO PARTICIPANTS WORKSHOP.
MY NAME IS MATT GILLMAN,
DIRECTOR OF THE ECHO PROGRAM.
MY JOB IN THE NEXT 10 MINUTES OR
SO IS TO SET THE STAGE FOR THESE
TWO DAYS ALONG WITH CLAY MASH,
OUR WONDERFUL CO-CHAIR.
THIS WORKED BEFORE BUT IT'S NOT
WORKING NOW.
THERE WE GO.
SO FIRST I'D LIKE TO GIVE A WARM
WELCOME TO THOSE IN THE ROOM.
SO WE'RE REALLY PLEASED AND
HONORED TODAY TO HAVE FOUR ECHO
PARTICIPANTS.
WHO ARE SITTING NEAR THE FRONT
OF THE TABLE ON BOTH SIDES.
AND WHEN WE GO AROUND THE ROOM
AND INTRODUCE, YOU'LL GET TO
HEAR THEIR VOICES.
AND IT'S REALLY A PRIVILEGE TO
HAVE YOU HERE TODAY.
WE ENCOURAGE YOU TO PARTICIPATE
TO YOUR HEART'S CONTENT AS MUCH
AS YOU FEEL COMFORTABLE.
YOU'LL BE HEARING SCIENTISTS WHO
SORT OF TALK TO THEMSELVES A
LOT, SO WHEN YOU HEAR THINGS
THAT DON'T MAKE SENSE, PLEASE
LET US KNOW AND WE'RE LOOKING
FORWARD TO YOUR CONTRIBUTIONS
AND QUESTIONS.
I'D ALSO LIKE TO THANK OUR
SPEAKERS, OUR INVITED SPEAKERS,
OF WHOM YOU'LL HEAR FROM OVER
THE NEXT TWO DAYS, AND OUR
DISCUSSANTS, WHO WILL, AT THE
END OF THE TALKS AND MOST OF THE
SESSIONS KICK OFF OUR DISCUSSION
PERIOD.
AND OF COURSE WE ALSO WELCOME
THOSE ON ZOOM IN VIRTUAL LAND.
THANK YOU VERY MUCH FOR JOINING
US TODAY.
AND DURING THE DISCUSSION
PERIOD, YOU'LL BE ABLE TO
ADDRESS QUESTIONS THROUGH THE Q
& A FUNCTION ON ZOOM WHICH CLAY
WILL TELL YOU A LITTLE BIT MORE
ABOUT.
SHOULD I SAY NEXT SLIDE?
OKAY, THANK YOU.
SO A SPECIAL THANKS TO OUR
WORKSHOP PLANNING COMMITTEE.
CLAY IS OUR WONDERFUL LEADER AND
THIS SLIDE SHOWS THAT WE'VE HAD
PLANNING COMMITTEE THAT CONSISTS
OF PEOPLE FROM ECHO AS WELL AS
OTHER PARTS OF NIH.
MANY OF WHOM YOU'LL SEE AS
SESSION MODERATORS OR ZOOM
MONITORS.
THE SESSION MODERATORS ARE IN
YELLOW, THEY'RE SITTING AT THE
TABLE TODAY, YOU'LL HEAR THEM
INTRODUCE THEMSELVES AND WE'LL
HAVE ZOOM MONITORS.
UNFORTUNATELY ASHLEY VARGAS IS
SICK TODAY SO CLAY WILL STEP IN
FOR ASHLEY.
SO WHY ARE WE HERE?
I'M JUST GOING TO GIVE A FEW
SLIDES OF BACKGROUND JUST TO
WHET YOUR APPETITE BECAUSE
YOU'LL BE HEARING A LOT MORE
FROM OUR SPEAKERS.
BUT TO SET THE STAGE A LITTLE
BIT, RESEARCHERS HAVE
HISTORICALLY -- TYPICALLY
LIMITED TO THEM TO WHAT
RESEARCHERS HAVE DEEMED
CLINICALLY ACTIONABLE RESULTS.
SO IN THIS DAY AND AGE, WE'RE
ASKING WHY ONLY CLINICAL IF WE
HAVE STUDIES LIKE ECHO WHICH ARE
BASED ON GENERAL POPULATIONS OR
PUBLIC HEALTH, SHOULD WE BE
RETURNING RESULTS DIRECTLY TO
PARTICIPANTS WITH SOME OTHER
KIND OF SUPPORT OF CLINICAL?
AND ALSO WHO GETS TO DECIDE WHAT
IS ACTIONABLE?
ACTIONABLE FOR ONE PERSON MIGHT
BE NOT FOR ANOTHER PERSON.
RESEARCH MIGHT BE DIFFERENT FROM
A PARTICIPANT.
AND ACTUALLY DOES IT MATTER IF
WE TERM IT ACTIONABLE FROM THE
CLINICIAN OR RESEARCHER POINT OF
VIEW?
MAYBE SOME OTHER ACTION LIKE
JUST INFORMATION IS IMPORTANT.
SO WITH THESE QUESTIONS IN MIND,
THERE HAVE BEEN RECENT CHANGES
IN ATTITUDES AND APPROACHES.
YES, THERE'S BEEN MORE
PARTICIPANT ENGAGEMENT WITH
RESEARCH, AND ONE OF THE REASONS
THAT WE'RE HAVING THIS WORKSHOP
IS THAT WE SEE THAT REPORT BACK,
RETURN OF INDIVIDUAL RESULTS, IS
ONE ELEMENT OF ENGAGEMENT WITH
PARTICIPANTS IN RESEARCH.
I WOULD SAY WE'RE MOVING TOWARDS
MORE TRANSPARENCY AND WHAT WE DO
IN THE RESEARCH ENTERPRISE.
THERE'S MORE EVIDENCE FOR BEST
PRACTICES IN WHAT AND WHEN AND
HOW TO RETURN RESULTS, AND,
THEREFORE, WE'VE SEEN A MOVE
TOWARDS MORE RETURN OF
INDIVIDUAL RESULTS, AND I THINK
A TURNING POINT IN THIS
DISCUSSION WAS THE NATIONAL
ACADEMIES REPORT, A LANDMARK
REPORT THAT CAME OUT IN 2018,
AND WE HAVE SOME PEOPLE HERE WHO
HAVE BEEN ON THAT PANEL, AND
IT'S REALLY SORT OF SET THE
STAGE WITH SOME NEW PRINCIPLES
AND ETHICAL APPROACHES.
AT THE SAME TIME, THERE REMAIN
CONCERNS ABOUT REPORT-BACK.
WHAT IS RESEARCH?
RESEARCH AIM IS TO INFORM.
IT'S ABOUT GENERALIZED
KNOWLEDGE.
NOT PRIMARILY ABOUT INDIVIDUAL
BENEFITS.
AND WHEN WE TALK ABOUT
INDIVIDUAL BENEFIT, IT'S
DIFFERENT FROM THE MAIN AIM OF
DOING RESEARCH.
SO KEEP THAT IN MIND.
THERE'S BEEN A CONCERN ABOUT
POTENTIAL HARMS WITH
PARTICIPANTS PERHAPS
MISINTERPRETING RESULTS, AND I
THINK WE'LL HEAR ABOUT HOW BIG A
PROBLEM THAT IS OR HOW SMALL A
PROBLEM IT IS.
SOMETIMES THERE'S A CONFUSION
BETWEEN RESEARCH RESULTS AND
CLINICAL RESULTS.
SO RESEARCHERS GET DATA WHICH
MAY NOT BE CLINICALLY
ACTIONABLE.
I REFERENCED THAT ON A PREVIOUS
SLIDE.
AND THEN, OF COURSE, THERE'S THE
HOW, WHICH, YOU KNOW, REQUIRES
RESOURCES, IT REQUIRES STAFFING
AND EXPERTISE AND TECHNOLOGY,
AND HOW MUCH CAN WE DO FEASIBLY.
AND THEN THERE'S STILL MANY
GAPS.
SO WHAT WE RECOGNIZE, AND ONE OF
THE REASONS WE'RE HAVING THIS
WORKSHOP IS THAT MOST RESEARCH
AND PRACTICES TO DATE ARE ABOUT
GENETICS, AND THAT'S -- YOU
KNOW, THERE'S BEEN A LOT OF
MOVEMENT, RESEARCH, AND NOW BEST
PRACTICES IN RETURN OF GENETIC
RESULTS.
AND MOST OF IT HAS BEEN AMONG
ADULT NON-PREGNANT PARTICIPANTS.
BUT WHAT ABOUT PRINCIPLES AND
BEST PRACTICES FOR NON-GENETIC,
WHAT WE CALL ENVIRONMENTAL
RESULTS, FOR PREGNANT
PARTICIPANTS AND CHILDREN AND
ADOLESCENTS, AND HOW DO WE SHARE
EQUITY IN REPORT-BACK?
SO THIS WORKSHOP AIMS TO FILL
THESE GAPS.
SO WHY IS ECHO INTERESTED IN
THIS?
WELL, WHAT'S ECHO?
ENVIRONMENTAL INFLUENCES ON
CHILD HEALTH OUTCOMES.
ITS MISSION IS TO ENHANCE THE
HEALTH OF CHILDREN FOR
GENERATIONS TO COME.
AND OUR GOAL IS TO UNDERSTAND
THE EFFECTS OF A BROAD RANGE OF
EARLY ENVIRONMENTAL EXPOSURES ON
CHILD HEALTH AND DEVELOPMENT IN
THE FIVE OUTCOME DOMAINS THAT
YOU SEE AT THE BOTTOM, PRE, PERI
AND POSTNATAL OUTCOMES, UPPER
AIRWAY, OBESITY, AND MANY FACETS
OF HEALTH AND WELL-BEING.
AND WE DO THIS THROUGH
OBSERVATION AND INTERVENTION
RESEARCH.
OBSERVATIONAL THROUGH OUR ECHO
COHORTS AND INTERVENTION THROUGH
THE IDEA STATES PEDIATRIC
CLINICAL TRIALS NETWORK.
OVERALL THESE ENCOMPASS 44
STATES, D.C. AND PUERTO RICO.
AND OUR OBSERVATIONAL RESEARCH,
WE'RE WAITING TO GATHER DATA
FROM 69 PRE-EXISTING AND ONGOING
MATERNAL CHILD COHORT STUDIES.
SO WE'VE AMASSED A DATA PLATFORM
WHICH HAS LONGITUDINAL DATA FROM
PRECONCEPTION TO AGE 21 YEARS.
IT REPRESENTS A DIVERSE
POPULATION OF OVER 50,000
CHILDREN PLUS THEIR FAMILY
MEMBERS.
AND THIS IS A MULTIDISCIPLINARY
CONSORTIUM WHICH INVOLVES OVER A
THOUSAND INVESTIGATORS, WHICH
HAS BEEN QUITE PRODUCTIVE SINCE
2016, WITH 1,000 -- MORE THAN A
THOUSAND PAPERS PUBLISHED.
MOST OF THOSE WERE IN THE
INDIVIDUAL COHORTS THAT CAME IN
TO THE CONSORTIUM, BUT, OF
COURSE, THE RESON DETRA -- THE
PAPERS ARE INCREASING, THERE ARE
MORE THAN 100 OF THEM, WE CALL
THEM ECHO-WIDE COHORT PAPERS.
THE GOALS OF THE NETWORK ARE
TO PROVIDE ACCESS TO STATE OF
THE ART MULTICENTER CLINICAL
TRIALS AMONG CHILDREN FROM RURAL
OR UNDERSERVED COMMUNITIES IN
STATES WITH HISTORICALLY LOW
RATES OF NIH FUNDING, AND TO
BUILD NATIONAL PEDIATRIC
RESEARCH CAPACITY TO CO CONDUCT
SUCH TRIALS.
TO DATE, THE NETWORK HAS SEEN
OVER A DOZEN COMPLETED TRIALS OR
IN THE FIELD OR IN DEVELOPMENT
CLOSE TO BEING FIELDED.
OKAY.
AND WITHIN ECHO, OUR
INVESTIGATORS HAVE CREATED A
POLICY FOR RETURN OF INDIVIDUAL
RESULTS.
THE CURRENT POLICY WAS RATIFIED
ABOUT THREE YEARS AGO.
AND IT RECOGNIZED THE FEDERATED
NATURE OF THE ECHO COHORT.
SO WE HAD THESE 69 COHORTS COME
TOGETHER.
THEY HAD DIFFERENT CULTURES,
DIFFERENT TRADITIONS, DIFFERENT
DISCIPLINES, AND SO THIS POLICY
RECOGNIZED THAT, AND SO IT WAS
TYPICALLY ON THE CONSERVATIVE
SIDE.
SO RETURNING -- SUGGESTING
RETURNING FEWER THAN MORE
RESULTS.
BUT AS WE GO INTO THE SECOND
CYCLE OF THE ECHO COHORT, WHICH
WILL BEGIN LATER THIS YEAR, I
THINK WE HAVE AN OPPORTUNITY FOR
REFINEMENT AND ENHANCEMENT.
SO WE'RE MOVING MORE TOWARDS A
SINGLE COHORT WITH STUDY SITES,
RATHER THAN THE MULTIPLE COHORTS
VIEW OF CYCLE 1, WHICH MEANS
THERE WILL BE MORE SENTIZATION
CENTRALIZATION AND
STANDARDIZATION SO WE WANT TO
MOVE TOWARDS BEST PRACTICES IN
THIS NEW ERA OF ECHO BASED ON
UPDATED PRINCIPLES.
SO THE WORKSHOP PURPOSE,
THEREFORE, IS TO IDENTIFY BEST
PRACTICES FOR LARGE SAMPLE
STUDIES OF PREGNANCY AND
CHILDHOOD TO ETHICALLY AND
FEASIBLY RETURN INDIVIDUAL
RESULTS TO PARTICIPANTS.
AND YOU'LL HEAR THIS PURPOSE
FROM CLAY AS WELL IN JUST A FEW
MINUTES.
BUT IN ADDITION TO IDENTIFYING
BEST PRACTICES, ON THE SORT OF
SURROUND SIDE, WE WANT TO
SPECIFY THE PRINCIPLES THAT LEAD
TO THE BEST PRACTICES, AND TO
IDENTIFY RESEARCH GAPS IN
IMPLEMENTING BEST PRACTICES.
SO WHEN WE IMPLEMENT THEM, HOW
DO WE STUDY THEM, AND WHAT KIND
OF EVIDENCE DO WE NEED BEFORE WE
IMPLEMENT BEST PRACTICES?
BECAUSE WE WISH TO INFORM THE
ECHO PROGRAM ON BOTH SIDES, THE
OBSERVATIONAL AND INTERVENTION
SIDE, AS WELL AS OTHER LARGE
LONGITUDINAL STUDIES OF
PREGNANCY AND CHILDHOOD.
SO LET ME STOP THERE AND BEFORE
I INTRODUCE CLAY, I THOUGHT IT
WOULD BE JUST A GOOD IDEA TO GO
AROUND THE ROOM AND INTRODUCE
OURSELVES AT THE TABLE.
WE DIDN'T ACTUALLY RESERVE TIME
FOR THIS SO I'M SORRY WE'RE
GOING TO GO OVER FIVE MINUTES.
ALREADY APOLOGIZING FOR TIME.
BUT I THINK IT WOULD BE GREAT
FOR EVERYONE TO KNOW WHO'S AT
THE TABLE.
SO I THINK WE'RE GOING TO START
WITH YOU AND THEN GO AROUND THIS
WAY AND END WITH OUR ECHO
PARTICIPANTS.
SO IF YOU COULD JUST SAY WHO YOU
ARE AND WHERE YOU'RE FROM AND
JUST ONE PHRASE ABOUT YOUR
INTEREST IN THIS WORKSHOP, THAT
WOULD BE GREAT.
JYOTI, WHY DON'T YOU GO AHEAD.
>>GOOD MORNING, MY NAME IS
JYOTI ANGAL.
I REPRESENT THE SOUTH DAKOTA
COHORT IN ECHO.
AND ONE INTEREST IN THIS
WORKSHOP IS TO BE ABLE TO SHARE
THE PLATFORM WITH THE ECHO
PARTICIPANTS AND HOW OFTEN DO WE
GET TO DO THAT, WHEN WE ARE
TALKING OR IN THE SAME ROOM WITH
PARTICIPANTS.
>>THANK YOU, JYOTI.
AND YOU'VE ALREADY DEMONSTRATED
EXCELLENT USE OF THE MICROPHONE.
BY TURNING IT ON WHEN YOU'RE
SPEAKING AND ADRIANA, WHEN
YOU'RE DONE, PLEASE TURN IT OFF.
>>HELLO.
MY NAME IS ADRIANA FROM THE
UNIVERSITY OF SAN DIEGO, AND FOR
THE LAST 10 YEARS OR SO, WE'VE
BEEN DEVELOPING INFO GRAPHICS TO
RETURN RESEARCH DATA AS WELL AS
OTHER CLINICAL DATA SO YOU'LL
GET TO SEE THOSE A LITTLE LATER
TODAY.
>>HI, I'M BEN BERKMAN, FACULTY
MEMBER IN THE DEPARTMENT OF
BIOETHICS, THE GENOME INSTITUTE,
AND A LOT OF MY RESEARCH HAS
BEEN ABOUT RETURN OF RESULTS
OVER THE PAST DECADE AND A HALF,
AND SO I'M REALLY INTERESTED TO
HEAR THE DELIBERATION AND HOW WE
CAN IMPLEMENT SOME OF THESE
DEBATES AND IDEAS IN THE ECHO
PROGRAM.
>>GOOD MORNING, INGRID HOLM,
PEDIATRIC GENETICIST AT BOSTON
CHILDREN'S HOSPITAL, PROFESSOR
OF PEDIATRICS AT HARVARD MEDICAL
SCHOOL.
I'VE BEEN DOING RESEARCH IN --
SOCIAL ISSUES IN GENOMICS FOR A
NUMBER OF YEARS AND IN
PARTICULAR, STUDIES ON MATERNAL
RESULTS IN CHILDREN SO VERY
HAPPY TO BE HERE.
>>HI.
I'M ADAM BERGER, DIRECTOR OF THE
DIVISION OF CLINICAL RESEARCH
AND HEALTH POLICY, PART OF THE
OFFICE OF SCIENCE POLICY, PART
OF THE DIRECTOR'S OFFICE.
I'VE BEEN IN THE SPACE FOR
RETURN OF RESEARCH RESULTS FOR A
LONG TIME.
I WAS ONE OF THE DRIVERS BEHIND
THE NATIONAL ACADEMIES REPORT
THAT MATT ACTUALLY MENTIONED IN
HIS TALK, AND WE'RE THINKING
ABOUT HOW WE CAN ACTUALLY
FACILITATE A FRAMEWORK HERE AT
NIH SO THAT WE CAN ENABLE
GREATER RETURN.
THANKS.
>>I'M JULIA BRODY.
WE STUDY ENVIRONMENTAL CHEMICALS
IN BREAST CANCER IN A COMMUNITY
ENGAGED CONTEXT.
THAT LED US TO BEGIN REPORTING
RESULTS FOR ENDOCRINE DISRUPTING
COMPOUNDS ABOUT 25 YEARS AGO,
AND TO KEEP WORKING ON IMPROVING
OUR METHODS AND UNDERSTANDING
PARTICIPANTS' EXPERIENCES.
>>HI, I'M RACHEL FROM U.C.
SCHOOL OF PUBLIC HEALTH, DO A
LOT OF RESEARCH, COMMUNITY-BASED
PARTICIPATORY RESEARCH IN MY
WORK IN COLLABORATION WITH FOLKS
AT SILENT SPRING INCLUDING JULIE
HAVE DONE A LOT OF RESULTS
RETURN AND REPORT-BACK FOR AMONG
TIE VERSE COMMUNITIES AND ALSO
HAD THE PLEASURE OF WORKING WITH
JYOTI ON THE RESULTS RETURN TASK
FORCE FOR ECHO.
AND I REPRESENT THE CHEMICALS IN
OUR BODIES COHORT OF ECHO.
>>MY NAME IS CARMEN VAN DER
SLOCARMEN VELEZ-VEGA,UNIVERSITY.
I'M HERE BECAUSE WE'VE BEEN
DOING REPORT-BACK FOR SEVERAL
YEARS IN PARTNERSHIP WITH SILENT
SPRING, AND RETURNING RESULTS OF
ENVIRONMENTAL INFORMATION, AND
IT HAS BEEN A WONDERFUL
EXPERIENCE AND HOPEFULLY THIS IS
SOMETHING THAT'S GOING TO CATCH
ON TO ALL THAT'S DOING STUDIES
IN THIS AREA.
CONTRIBUTING TO WHAT I THINK IS
A SOCIAL JUSTICE ISSUE.
>>HI, MY NAME IS MONICA
RAMIREZ, ASSOCIATE PROFESSOR OF
PUBLIC HEALTH AT THE UNIVERSITY
OF ARIZONA.
I'M REPRESENTING TUCSON, ARIZONA
RIGHT ALONG THE U.S./MEXICO
BORDER REGION, AND SO I'VE BEEN
DOING CO-CREATED COMMUNITY
SCIENCE PROJECTS FOR ABOUT 10
YEARS TO INCLUDE A LARGE
REPORT-BACK COMPONENT AND I'VE
BEEN WORKING WITH COMMUNITIES
THAT ARE NEIGHBORING RESOURCE
EXTRACTION AND E.J. COMMUNITIES
IN URBAN AND RURAL SPACES.
THANK YOU.
>>GOOD MORNING, I'M KIM
MCALLISTER, PROGRAM OFFICER AT
THE NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES,
AND I HAVE BEEN INVOLVED IN ECHO
AND I MANAGE SOME ELSI GRANTS IN
MY PORTFOLIO.
>>GOOD MORNING.
I'M JULIE HERBSTMAN FROM
COLUMBIA UNIVERSITY.
I AM AN ENVIRONMENTAL
EPIDEMIOLOGIST AND ALSO AN ECHO
COHORT P.I.
WE'VE BEEN DOING SOME
REPORT-BACK OF CHEMICAL
ENVIRONMENTAL EXPOSURES THAT
I'LL GET TO TALK ABOUT A LITTLE
BIT LATER THIS MORNING AND HAVE
ALSO WORKED ON THE POLICY THAT
MATT MENTIONED A BIT EARLIER TO
BRING THESE IDEAS TO THE ECHO
CONSORTIUM.
>>I'M JEFF BOTKIN,
PEDIATRICIAN, PROFESSOR EMERITUS
AT UNIVERSITY OF UTAH.
MOST OF MY WORK OVER THE YEARS
HAS BEEN ON ELSI ISSUES, AND I
CHAIRED THE CONSENSUS STATEMENT
FOR THE NATIONAL ACADEMIES ON
RETURN OF RESULTS.
>>GOOD MORNING, I'M GAYA
DOWLING, ADOLESCENT BRAIN
DEVELOPMENT STUDY HOUSED AT THE
NATIONAL INSTITUTE ON DRUG
ABUSE.
WE ARE VERY MUCH INTERESTED IN
BEST PRACTICES FOR HOW AND WHEN
TO RETURN RESULTS TO
PARTICIPANTS.
>>I'M KYLE BROTHERS FROM NORTON
CHILDREN'S RESEARCH INSTITUTE
AND THE UNIVERSITY OF LOUISVILLE
IN KENTUCKY.
I'M A PEDIATRICIAN AND
BIOETHICIST AND WORKED ON RETURN
OF RESULTS IN THE GENETIC SPACE
FOR A NUMBER OF YEARS.
>>GOOD MORNING, MY NAME IS
SUNDANIA WONNUM FROM THE
NATIONAL INSTITUTE OF MINORITY
HEALTH AND HEALTH DISPARITIES
WHERE WE'RE CONCERNED ABOUT THE
SOCIAL JUSTICE IMPACT OF
RESEARCH WE DO PARTICULARLY
AMONG VULNERABLE AND
MARGINALIZED POPULATIONS.
>>I'M JOHNNYE LEWIS, A
TOXICOLOGIST AT THE UNIVERSITY
OF NEW MEXICO, AND IN 1996,
STARTED A COMMUNITY PARTNERED
RESEARCH PROGRAM THERE, AND WHEN
YOU WORK IN PARTNERSHIP,
RETURNING RESULTS IS PRETTY
CRITICAL, SO I'VE BEEN REALLY
EXCITED ABOUT EXPANDING THAT
NETWORK INSIDE OF ECHO.
>>HI, EVERYONE.
I AM FROM PUERTO RICO.
I'M HERE BECAUSE I'M WORKING
WITH REPORT-BACK AND I THINK
IT'S AN ISSUE OF -- I THINK THE
PARTICIPANTS NEED TO KNOW THE
RESULTS IN THE RESEARCH.
>>GOOD MORNING, ALL.
I'M COMING FROM PUERTO RICO,
ESPECIALLY FROM THE NORTH.
I PARTICIPATE IN THE PROGRAM IN
2016.
I TRY TO -- HEALTHY AS MOST I
CAN AND I REALLY CARE ABOUT THE
ISSUES THAT AFFECT MY LIFE, MY
ENVIRONMENT AND MY COMMUNITY, SO
THAT'S WHY WE ARE HERE.
>>HI, I'M JAYDEN BENJAMIN HERE
ON BEHALF OF THE L GAIN COHORT
STUDY.
I'M INTERESTED IN LEARNING ABOUT
HOW I CONTRIBUTED TO THE STUDY
AND WHAT I CAN LEARN FROM THE
THINGS I'VE GIVEN TO THE STUDY.
THANK YOU.
>>I'M CLAY MASH, PROGRAM
OFFICER IN THE ECHO PROGRAM
OFFICE, AND HAVE BEEN INTERESTED
IN RETURN OF RESULTS FOR QUITE A
WHILE NOW.
HAPPILY INVOLVED IN HELPING TO
COORDINATE THIS WORKSHOP.
THANK YOU.
>>GOOD MORNING.
MY NAME IS PAMELA GUYE FROM
ARIZONA, NAVAJO NATION.
I AM A PART OF THE ECHO STUDY
WITH MY 3-YEAR-OLD DAUGHTER.
SO I'M A MOM IN ECHO, AND MY
DAUGHTER PAISLEY IS THE
PARTICIPANT, SO I'M GLAD TO BE
HERE.
I'M GLAD THAT WE COULD SHARE A
LOT OF OUR INFORMATION THAT
COMES FROM ACROSS THE COUNTRY.
>>HI, I'M EMILY MONROE WITH THE
NEW HAMPSHIRE BIRTH COHORT
STUDY.
I HAVE FOUR CHILDREN CURRENTLY
ENROLLED AND A FIFTH ON THE WAY
TO BEING ENROLLED.
AND HAPPY TO SHARE EXPERIENCES
IN REPORTING BACK.
I AM AN ENGINEER AND I LOVE
DATA, SO YOU WILL HEAR THAT IN
MY RESPONSES.
>>GOOD MORNING, EVERYONE.
MY NAME IS JULIE SAPP, GENETIC
COUNSELOR IN THE CENTER FOR
PRECISION HEALTH RESEARCH IN
NHGRI WHERE I STUDY THE
IMPLEMENTATION OF GENOMIC
MEDICINE AND ALSO HAVE A SPECIAL
INTEREST IN HOW PEOPLE USE
MEDICALLY ACTIONABLE RESULTS
THAT ARE RETURNED BOTH IN THE
CLINICAL AND RESEARCH CONTEXT.
SO THANKS.
>>THANKS, EVERYONE AROUND THE
TABLE.
WE ALSO HAVE SOME OBSERVERS IN
THE BACK, THOSE OF YOU O ON THE
ZOOM AUDIENCE MAY BE ABLE TO SEE
THEM ON OCCASION.
AT THIS POINT, I'D LIKE TO TURN
THE PODIUM OVER TO CLAY.
CLAY SORT OF UNDERSOLD HIMSELF
WHEN HE SAID I'M JUST A
CONTRIBUTOR TO THIS WORKSHOP.
HE'S REALLY BEEN THE DRIVER
BEHIND IT.
AND THOSE WHO HAVE BEEN INVOLVED
IN WORKSHOP PLANNING KNOW THAT
AND A THOSE OF YOU WHO ARE HERE
WILL RECOGNIZE THAT THROUGHOUT
THE SESSIONS TODAY AND TOMORROW,
SO CLAY, PLEASE.
>>THANK YOU, MATT.
I WANT TO REPEAT MATT'S WELCOME
AND THANKS TO EVERYBODY WHO'S
HERE TO SPEAK AND DISCUSS AND
OUR PARTICIPANTS ESPECIALLY, AND
THANKS TO THOSE WHO HAVE HELPED
COORDINATE THE WORKSHOP.
ONE MOMENT.
NEXT SLIDE, PLEASE.
SO AS MATT MENTIONED, THERE'S A
LOT OF WORK, MOST OF YOU HAVE
KNOW THERE'S A LOT OF INTEREST
NOW IN RETURNING INDIVIDUAL
RESULTS TO RESEARCH
PARTICIPANTS, BUT THERE ARE SOME
GAPS TO FILL.
OUR PURPOSE FOR THIS WORKSHOP IS
TO IDENTIFY BEST PRACTICES FOR
LARGE SAMPLE STUDIES OF
PREGNANCY AND CHILDHOOD TO
ETHICALLY AND FEASIBLY RETURN
INDIVIDUAL RESEARCH RESULTS TO
PARTICIPANTS.
AND OUR WORKSHOP HAS BEEN
ORGANIZED AND THOUGHT ABOUT WITH
SOME CROSS-CUTTING THEMES, SO
HOW SHOULD RECOMMENDATIONS
DIFFER FOR RETURNING INDIVIDUAL
RESULTS TO PREGNANT PEOPLE AND
CHILDREN VERSUS THOSE OF OTHER
ADULTS?
ALSO, MOST RESEARCH ON RETURNING
RESULTS HAS FOCUSED ON GENETICS
RESULTS, VERY IMPORTANT AND
INTERESTING, BUT HOW CAN WE
BROADEN TO INCLUDE ENVIRONMENTAL
DATA FROM BIOASSAYS, PHYSICAL
MEASURES, SELF-REPORTS AND OTHER
KIND OF THINGS THAT RESEARCH
PARTICIPANTS ARE INTERESTED IN
HEARING ABOUT, AND THAT LARGE
PROGRAMS LIKE ECHO HAVE TO
OFFER.
AND THEN ALSO HOW CAN WE
FACILITATE EQUITY IN THE RETURN
OF INDIVIDUAL RESULTS?
SO JUST BY BROAD OVERVIEW, OUR
WORKSHOP IS ORGANIZED INTO FIVE
SESSIONS.
TODAY WE'LL HAVE HISTORY AND
PRINCIPLES FOR RETURNING
INDIVIDUAL RESEARCH RESULTS.
WE'LL HAVE A SECOND SESSION ON
THE VALUE OF INDIVIDUAL RESULTS
TO PARTICIPANTS FROM THEIR OWN
PERSPECTIVE.
AND FORTUNATELY AND LUCKILY
WE'LL BE ABLE TO HEAR FROM SOME
OF OUR ECHO PARTICIPANTS IN THAT
SESSION.
ALSO WE'LL HEAR ABOUT
DETERMINING WHICH INDIVIDUAL
RESULTS TO RETURN TO
PARTICIPANTS.
THAT'S A CHALLENGING ISSUE IN
MANY RESPECTS AND WE'LL HEAR
ABOUT HOW TO MAKE SOME OF THOSE
DECISIONS.
THEN ON TOMORROW, WE WILL HEAR
ABOUT WHEN AND HOW TO RETURN
INDIVIDUAL RESULTS IN SESSION 4,
AND THEN WE'LL HAVE A FINAL
WRAP-UP SESSION WHERE WE'LL
REALLY TRY TO DERIVE SOME ACTUAL
PRINCIPLES AND PRACTICES MOVING
FORWARD FOR LARGE STUDIES OF
PREGNANCY AND CHILDHOOD.
SO JUST A QUICK GROUNDWORK FOR
THE FORMAT OF THE SESSIONS.
THE TALKS WILL BE 15 MINUTES,
AND THEN THERE WILL BE FIVE
MINUTES FOR QUESTIONS AFTER EACH
TALK.
FOR SESSIONS 1, 3 AND 4, THERE
WILL BE A DISCUSSANT WITH FIVE
MINUTES, AND THEN OPEN
DISCUSSION FOR 50 MINUTES, OF
WHICH EVERYONE IN THE ROOM AND
FOLKS ONLINE CAN RAISE THEIR
HAND, BE ACKNOWLEDGED BY THE
MODERATOR, AND ASK A QUESTION.
FOR PEOPLE ONLINE, THERE WILL BE
A ZOOM MONITOR, WHO WILL BE
LOOKING AT QUESTIONS, SO GO INTO
THE CHAT AND ENTER A QUESTION.
THERE WILL BE MORE DETAILS ABOUT
THAT SOON.
AND THEN SESSION 2, THERE WILL
BE A PARTICIPANT PANEL THAT WILL
BE FOR 50 MINUTES INSTEAD OF THE
OPEN DISCUSSION, AND THAT'S
WHERE WE'LL GET TO HEAR DIRECTLY
FROM OUR PARTICIPANTS.
SO FOR MORE DETAIL ON SPEAKER,
DISCUSSANTS AND PANEL BUY YOES,
WE ASK YOU TO REFERENCE THE
PROGRAM BOOK TO SAVE TIME, WE'LL
BE KIND OF BRIEF WITH SPEAKER
INTRODUCTIONS AND DISCUSSANT
INTRODUCTIONS BUT THEIR BIOS ARE
ON THE PROGRAM BOOK WHICH IS
ONLINE, WHICH YOU SHOULD HAVE
RECEIVED INFORMATION ABOUT.
SO FOR SOME HOUSEKEEPING FOR
PEOPLE IN THE ROOM, PLEASE PAY
ATTENTION IF YOU'RE A SPEAKER OR
DISCUSSANT TO THE TIME.
WE'RE GOING TO BE ON A STRICT
TIME LIMIT AFTER I FINISH, AND
FOR SPEAKERS IN THE 15-MINUTE
SLOTS, THERE WILL BE A --
THERE'S A LIGHT UP HERE AND
YOU'LL BE GREEN FOR THE FIRST 13
MINUTES.
WHEN YOU'RE DOWN TO TWO MINUTES,
THE LIGHT WILL TURN YELLOW.
THE YELLOW LIGHT INDICATES THAT
YOU HAVE 2 MINUTES LEFT TO WRAP
THINGS UP.
AND THEN WHEN IT'S RED, IT'S
TIME TO STOP SPEAKING.
FOR THE DISCUSSANT PERIODS, THE
YELLOW LIGHT WILL COME ON IN
YOUR FIVE-MINUTE PRESENTATION AT
THE ONE-MINUTE MARK.
FOR PANELISTS AND MODERATORS,
PLEASE BRING YOUR TENT CARDS
WITH YOU WHEN YOU COME TO THE
FRONT TABLE.
AND FOR EVERYONE IN THE ROOM,
LET'S TRY TO KEEP OUR COMPUTERS
OFF AS MUCH AS WE CAN, BUT IF
YOU HAVE TO TURN IT ON TO DO
SOMETHING CRITICAL AND URGENT,
JUST MAKE SURE TO MUTE YOUR
SOUND.
AND FOR PEOPLE TO SHARE INPUT
DURING Q & A PERIODS, PLEASE
RAISE YOUR HAND FOR THE
MODERATOR TO ADDRESS YOU, AND
THEN YOU NEED TO TURN ON YOUR
MICROPHONE EVERY TIME YOU SPEAK.
AND THEN WHEN YOU'RE DONE
SPEAKING, TURN IT OFF SO THAT WE
DON'T GET FEEDBACK IN THE ROOM.
AND YOU ALL DID THAT VERY WELL
DURING INTRODUCTIONS.
SO FOR BATHROOMS AND WATER
FOUNTAIN, JUST EXIT THE
CONFERENCE AREA, TURN LEFT, GO
TO THE END OF THE HALL AND MAKE
ANOTHER LEFT AND THEN GO THROUGH
THOSE DOORS.
AND WE DO HAVE A COUPLE OF
BREAKS DURING THE SESSIONS
TODAY.
SO VIRTUAL ATTENDEES, YOU'LL BE
MUTED THROUGHOUT THE WORKSHOP,
BUT TO SHARE A QUESTION DURING
THE Q & A, THE 50-MINUTE Q & A
PERIODS, YOU CAN TYPE IT INTO
THE INTERFACE AS SHOWN ON THE
RIGHT.
PRESS THE Q & A BUTTON AND ENTER
YOUR QUESTION.
IF YOU PREFER TO REMAIN
ANONYMOUS, PLEASE INDICATE THAT
IN YOUR ZOOM Q & A COMMENT, AND
WE WILL GET TO AS MANY QUESTIONS
AS TIME ALLOWS.
THETHEY WILL BE READ IN THE ROOF
SELECTED BY THE ZOOM MONITOR,
AND ACKNOWLEDGED BY THE
MODERATOR OF THE SESSION.
AND ONE LAST THING.
OTHER ZOOM ATTENDEES WILL NOT BE
ABLE TO SEE YOUR QUESTION, SO
FEEL FREE TO ASK WHATEVER YOU
WANT.
AND IF YOU HAVE ANY ISSUES WITH
TECH, PLEASE EMAIL AMANDA
HENNESSEY AT THE EMAIL ADDRESS
HERE.
AND THEN SOME ADDITIONAL
HOUSEKEEPING.
IT'S A HYBRID MEETING SO AGAIN,
USE YOUR MICS EVERY TIME YOU
SPEAK.
AND KEEP COMPUTERS OFF IF
POSSIBLE.
THE BREAK PERIODS ARE AT 11:15,
WE'LL HAVE A 10-MINUTE BIOBREAK,
AND THEN OUR LUNCH BREAK WILL BE
AT 1:00, AFTER WE FINISH THE
PARTICIPANT PANEL.
IF YOU'RE A TRAVELING SPEAKER,
YOU ORDERED YOUR LUNCH FOR
DELIVERY AND IT WILL ARRIVE HEE
AND THEN EVERYBODY ELSE IS FREE
TO VISIT THE SMALL CAFE THAT'S
ON THE OTHER SIDE OF THIS
COMPLEX.
IT WILL BE EASY TO FIND AND
THERE WILL BE A GROUP GOING.
AND I WANT TO ALSO ACKNOWLEDGE
OUR WORKSHOP PARTNERS, CARLY AND
AMANDA ARE AT THIS TABLE HERE IF
YOU HAVE ANY TECHNICAL
QUESTIONS, AND THEN MICHAEL HAS
BEEN IN AND OUT OF THE ROOM, AND
HE'S ALSO VERY HELPFUL.
OKAY.
NOW I WANT TO INTRODUCE KIM
MCALLISTER, WHO WILL BE
MODERATING SESSION 1.
>>OKAY, THANKS, CLAY, AND GOOD
MORNING, EVERYONE.
I AM A PROGRAM OFFICER AT THE
NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES.
AND I AM GOING TO MODERATE THIS
FIRST SESSION.
WHICH IS ENTITLED "THE HISTORY
AND PRINCIPLES FOR RETURNING
INDIVIDUAL RESEARCH RESULTS."
THIS SESSION IS GOING TO TRY TO
INTRODUCE THE CONCEPT OF
REPORT-BACK WITH A BRIEF HISTORY
AND EXAMINATION OF SOME OF THE
GUIDING PRINCIPLES.
AS WAS ALREADY MENTIONED
BRIEFLY, THE OBLIGATIONS TO
REPORT BACK HAVE SUBSTANTIALLY
EVOLVED OVER THE PAST COUPLE OF
DECADES, SO THERE IS A BROADER
UNDERSTANDING OF SEEING THE
COMMUNITY AS A FULL PARTNER, AND
PERHAPS EVEN A CO-OWNER OF DATA
IN THE RESEARCH PROJECT.
SO THERE'S A GENERAL EXPECTATION
THAT RESULTS SHOULD BE RETURNED
WHEN POSSIBLE, AS A MATTER OF
RECIPROCITY, RESPECT,
TRANSPARENCY, AND TRUST.
BUT THIS IS A FAIR LEA NEW FAIRW
RESEARCH PARADIGM FOR EVERYBODY
AND THERE ARE A LOT OF
COMPLEXITIES AND ETHICAL, LEGAL
AND REGULATORY ISSUES TO
CONSIDER WHEN DOING PLANNED
DISCLOSURE OF RESEARCH FINDINGS.
AND RELATED TO THE ECHO
CONSORTIUM AND A LOT OF OTHER
LARGE CONSORTIUM EFFORTS, AS
MATT MENTIONED, WE ARE NOW
MOVING FROM NOT JUST RETURNING
GENOMICS RESULTS, BUT ALSO
ENVIRONMENTAL RESULTS AND
SOMETIMES EVEN GENE ENVIRONMENT
INTERACTION RESULTS.
SO THIS FIRST SESSION IS REALLY
GOING TO TOUCH ON ALL OF THAT,
AND REALLY TRY TO SET THE STAGE
FOR ALL THE REMAINING SESSIONS
IN THE WORKSHOP.
AND I WANTED TO ACKNOWLEDGE
DR. JEFF BOTKIN FROM UNIVERSITY
OF UTAH AS THE CHAIR OF THIS
SESSION.
HE PUT A LOT OF TIME INTO
HELPING TO ORGANIZE IT, AND HE
IS THE FIRST SPEAKER.
FOLLOWING HIM, WE WILL HAVE
DR. KYLE BROTHERS FROM NORTON
CHILDREN'S RESEARCH INSTITUTE AT
UNIVERSITY OF LOUISVILLE, AND
THEN WE WILL HAVE DR. ADAM
BERGER FROM THE OFFICE OF
SCIENCE POLICY AT NIH, AND THEN
DISCUSSANT WILL BE DR. INGRID
HOLM FROM THE BOSTON CHILDREN'S
HOSPITAL AND HARVARD MEDICAL
SCHOOL.
AND AFTER THAT, THEN WE WILL
HAVE AN OPEN DISCUSSION FOR THIS
SESSION BEFORE IT ENDS.
SO WITH THAT, I'D LIKE TO TURN
THE PODIUM OVER TO JEFF.
>>GOOD MORNING, EVERYBODY.
WELL, THANK YOU.
AND THANKS TO THE ORGANIZERS,
MATT GILLMAN, CLAY MASH, FOR THE
UPDATED WORK TOGETHER AND THE
ABILITY TO CONTRIBUTE THIS VERY
IMPORTANT ECHO PROJECT.
I'M GOING TO TRY TO SET SOME OF
THE CONTEXT FOR THIS DISCUSSION,
AND WOULD START WITH A
RECOGNITION THAT WE'RE TALKING
ABOUT A POTENTIAL SPECTRUM OF
RESULTS.
PUBLIC RELEASE OF STUDY DATA,
PUBLICATIONS, FOR EXAMPLE,
PUBLICLY AVAILABLE DATABASES,
THAT'S ONE FORM OF AVAILABLE
RESULTS TO PARTICIPANTS.
SECONDLY, THE RETURN OF GENERAL
STUDY RESULTS TO PARTICIPANTS,
WHAT DID THE RESEARCH FIND, WAS
IT SUCCESSFUL, WHAT WERE THE
CONCLUSIONS THAT WERE DRAWN BY
THE STUDY?
THIRD, WHAT WE'RE REALLY FOCUSED
ON PRIMARILY WITH THIS WORKSHOP,
WHICH IS A RETURN OF INDIVIDUAL
STUDY RESULTS TO PARTICIPANTS,
AND THEN THERE'S BEEN AN
ENORMOUS AMOUNT OF DISCUSSION
OVER THE YEARS, PARTICULARLY IN
GENOMICS CONTEXT OF INCIDENTAL
FINDINGS.
AND I DON'T THINK WE'VE GOT TOO
MUCH DISCUSSION OF THAT, BUT WE
WANT TO KEEP THAT DOMAIN OF
POTENTIAL FINDINGS IN MIND AS WE
GO FORWARD.
SO ONE THING I WANT TO EMPHASIZE
HERE, AND AGAIN, THIS IS NOT
REALLY THE FOCUS OF THIS
WORKSHOP, BUT THE NOTION OF
RETURNING GENERAL STUDY RESULTS
TO PARTICIPANTS, TO ME, IS A
MUCH UNDEREMPHASIZED DOMAIN.
AND I THINK AS THE LITTLE
CALLOUT AT THE TOP HERE SUGGESTS
THAT WE REALLY MAY GET MANY OF
THE ADVANTAGES AND LOSE SOME OF
THE DISADVANTAGES AND RISK THAT
GIVE FOLKS BACK WHAT HAPPENED
WITH THE STUDY.
IT'S A WAY OF HONORING THEIR
PARTICIPANTS, HELPING THEM
UNDERSTAND WHAT THEY CONTRIBUTED
TO WITHOUT SOME OF THE
COMPLEXITIES AROUND INDIVIDUAL
OR PERSONAL RESULTS.
SO WHEN I THINK THERE'S SOME
DISCUSSION ABOUT CHALLENGES OR
CIRCUMSTANCES IN WHICH IT'S NOT
APPROPRIATE FOR INDIVIDUAL
RESULTS, I THINK THIS FROM MY
PERSPECTIVE OUGHT TO BE VIRTUAL
BOILERPLATE FOR ALL RESEARCH
WHERE YOU'RE MAINTAINING SOME
CONTACT AND IDENTIFYING
INFORMATION FOR THE
PARTICIPANTS.
LOOK LIKE WE'VE GOT ANOTHER
FROZEN -- SO NEXT SLIDE, PLEASE.
SO RETURN OF INDIVIDUAL RESULTS.
THAT PARTICULAR SET OF ISSUES.
I THINK THE OLD SCHOOL APPROACH,
WHICH I WOULD SAY MAYBE AROUND
PRE-2000 OR SO, IT WAS SIMPLY
NOT DONE.
AND I REMEMBER SO MANY TIMES AS
AN I.R.B. MEMBER AND
ADMINISTRATOR AT THE UNIVERSITY,
CONSENT FORMS WOULD SIMPLY SAY,
YOU'RE NOT GETTING ANY RESULTS
BACK.
AND THAT WAS SO EASY FOR
INVESTIGATORS, FOR REALLY GOOD
REASONS, I WOULD SAY.
THE OBLIGATIONS WERE UNCERTAIN.
THERE WAS CERTAIN NEED TO
PROTECT PEOPLE FROM WHAT MIGHT
PROVE TO BE INACCURATE OR
MISLEADING INFORMATION.
THERE'S A LACK OF TRADITION
THERE, PROTOCOLS, PEER REVIEW.
HOW DO WE DO THIS IN THE RIGHT
WAY?
PEOPLE REALLY HAD NOT THOUGHT
THAT THROUGH.
IT WAS A COMPLEX TASK TO DO IT
EFFECTIVELY.
THIS IS NOT EASY.
AND THEN LASTLY, YOU WOULD NEED
ADDITIONAL FUNDING AND
RESOURCES, AND YOU'D HAVE TO
PLAN THAT AT THE BEGINNING OF
YOUR RESEARCH PROTOCOL IN ORDER
TO HAVE THOSE RESOURCES
AVAILABLE.
SO FOR ALL OF THOSE KINDS OF
REASONS, FOLKS SIMPLY SAID,
YOU'RE NOT GETTING ANY RESULTS
BACK.
NOW, I WOULD SAY WE WANT TO MAKE
A DISTINCTION HERE BETWEEN SORT
OF RESEARCH RESULTS THAT ARE
BEING CONDUCTED OR PRODUCED OUT
OF, SAY, A CLIA CERTIFIED LAB.
A LOT OF DRUG STUDIES IN
PARTICULAR DO PREGNANCY TEST,
THEY MAY DO LIVER FUNCTION
TESTS, CBCs, THOSE SORTS OF
THINGS.
I DON'T THINK THERE'S BEEN MUCH
OF A PROBLEM OVER THE YEARS IN
RETURNING THOSE KINDS OF
RESULTS, AT LEAST WHEN THERE'S
SOME SORT OF RED FLAG RESULT.
YOU MAY NOT GET NORMAL RESULTS,
BUT IF THERE'S A PROBLEM THERE,
I THINK THE TRADITION HAS BEEN
PRETTY STRONG TO SAY PEOPLE ARE
GOING TO TELL YOU ABOUT THAT.
SO THAT'S REALLY NOT BEEN A
PROBLEMATIC AREA.
BUT ALSO, I THINK THE LITERATURE
IS PRETTY CLEAR, PEOPLE WANT AND
EXPECT RESULTS.
AND IT'S PRETTY CLEAR, TOO, THAT
EVEN WHEN YOU TELL FOLKS, YOU'RE
NOT GOING TO GET ANYTHING BACK,
STILL THEY'RE SAYING, WELL,
OKAY, WHERE'S MY RESULTS?
SO THERE'S A MISMATCH BETWEEN
WHAT THE CONSENT FORM MIGHT SAY
AND WHAT PEOPLE'S EXPECTATIONS
ARE.
SO WHAT'S THE CONTEXT HERE?
I THINK IMPORTANT TO RECOGNIZE
THAT WHEN RESULTS ARE NOT
RETURNED, THEN THE INFORMATIONAL
RISK OF THE RESEARCH IS CLOSE TO
ZERO.
I THINK WE HAVE, AS A RESEARCH
ENTERPRISE BROADLY, AN EXCELLENT
TRACK RECORD OF PROTECTING
PRIVACY AND CONFIDENTIALITY.
THESE ARE SORT OF PART OF THE
SO-CALLED INFORMATIONAL RISKS OF
THE RESEARCH ENTERPRISE.
BUT THE RISK OF HARM FROM
INFORMATION INCRO INCREASES WHEN
RESULTS ARE RETURNED.
SO THE ETHICAL CHALLENGE HERE IS
TO BALANCE THE BENEFITS OF
DISCLOSURE WITH THE RISKS OF
DISCLOSURE.
OUR CHALLENGE, OF COURSE, IS TO
HELP FIND WHAT THOSE MIGHT BE IN
A PARTICULAR CONTEXT.
BUT THIS IS ONE ELEMENT, THE
RETURN OF RESULTS IS ONE ELEMENT
OF A MUCH LARGER LANDSCAPE WHERE
THE RESEARCH COMMUNITY IS TRYING
TO DO A MUCH BETTER JOB IN BEING
TRUE PARTNERS WITH RESEARCH
PARTICIPANTS.
AND THE WHOLE NOTION OF SUBJECTS
AND INVESTIGATORS IS GOING AWAY,
EVEN WITH TERMINOLOGY CHANGED TO
SAY NOW WE'RE WORKING WITH
PARTICIPANTS AS OPPOSED TO
SUBJECTS.
SO WHAT ARE SOME OF THE CONCERNS
HERE?
WHAT ARE THE BROADER ISSUES?
WELL, RESEARCH RESULTS ARE OFTEN
UNCERTAIN IN TERMS OF VALIDITY
AND UTILITY.
IS THE ANALYSIS ACCURATE?
THE ANALYTIC VALIDITY OF THE
PIECE.
DO THE RESULTS TELL US SOMETHING
ABOUT THE CURRENT OR FUTURE
HEALTH OF THE PARTICIPANT?
SO CLINICAL VALIDITY.
ARE THE RESULTS USEFUL FOR
CLINICAL OR LIFE DECISIONS?
AND THESE ARE CLINICAL OR
PERSONAL UTILITY.
THESE ARE ALL CORE QUESTIONS.
AND ALSO, AND I THINK MATT HAD
HIGHLIGHTED THIS A BIT, AND I
DON'T THINK WE REALLY UNDERSTAND
THIS, THERE'S THIS WHOLE NOTION
OF THE THERAPEUTIC MISCONCEPTION
WHERE RESEARCH PARTICIPANTS MAY
BE UNCERTAIN OR A BIT CONFUSED
ABOUT WHAT THE RESEARCH
ENTERPRISE IS.
THE DIFFERENCE BETWEEN CLINICAL
CARE, WHERE THE PURPOSE VERSUS
BENEFIT TO YOU AS THE PATIENT OR
THE PURPOSE OF RESEARCH WHERE
THE PRIMARY PURPOSE IS TO ANSWER
A RESEARCH QUESTION.
THAT'S A BIT ABSTRACT FOR MANY
PARTICIPANTS, AND IF YOU GET
THOSE TWO CONFUSED, YOU MAY BE
PARTICIPATING IN RESEARCH
BECAUSE YOU THINK IT'S A
CLINICAL ENTERPRISE.
AND SO DOES THIS RETURN OF
RESULT HELP CLOUD THAT IMPORTANT
DISTINCTION?
I DON'T THINK WE KNOW THAT YET.
SO LET TALK A BIT ABOUT THE
RISKS HERE.
SO THE COMMUNICATION OF
INDIVIDUAL RESULTS MAY LEAD
INDIVIDUALS TO MAKE CRITICAL
HEALTHCARE OR LIFE DECISIONS
BASED ON FALSE, MISLEADING OR
MISINTERPRETED INFORMATION.
YOU MAY DO HARM.
THEY MAY DO HARM TO THEMSELVES
IF THEY HAVEN'T FULLY UNDERSTOOD
WHAT THE NATURE OF THE
INFORMATION IS.
IT MAY CREATE UNNECESSARY
CONFUSION AND ANXIETY IN
RESEARCH PARTICIPANTS,
PARTICULARLY IF THE RESULTS ARE
UNCERTAIN OR THEY DON'T HAVE A
CLEAR CHOICE BASED ON THE
INFORMATION YOU'RE GIVING THEM.
IT CERTAINLY MAY BURDEN THE
RESEARCH ENTERPRISE WITH NEW
COSTS AND COMPLEXITIES.
AND IT REDUCES THE VOLUME OF
RESEARCH CONDUCTED BECAUSE
RESOURCES ARE BEING USED FOR THE
COMMUNICATION OF RESULTS.
AND HERE I JUST REMEMBER SO WELL
WITH THE NATIONAL ACADEMIES
STUDY, WE HAD A MOTHER OF A
CHILD WITH MUSCULAR DYSTROPHY.
AND SHE WAS UPSET BECAUSE SHE
HAD NOT BEEN GIVEN A SET OF
RESULTS THAT MIGHT HAVE HELPED
HER INTERPRET THE CLINICAL
STATUS OF HER CHILD.
IT WAS A MUSCLE EVALUATION.
SO SHE WAS CONCERNED THAT THOSE
RESULTS HAD NOT BEEN RETURNED.
AT THE SAME TIME, SHE SAID, YOU
KNOW, MY MAIN GOAL IN
PARTICIPATING IN RESEARCH IS TO
CURE MY CHILD'S CONDITION.
THAT'S WHAT I CARE ABOUT, IS
CURING MUSCULAR DYSTROPHY.
AND IF YOU GUYS ARE SPENDING A
LOT OF TIME AND MONEY WITH THE
RETURN OF RESULTS AND THAT'S NOT
BEING USED TO HELP CURE MY BABY,
DON'T DO IT.
MY PRIORITY IS THE RESEARCH, AND
NOT SO MUCH THE RETURN OF
RESULTS.
SO THAT STUCK WITH ME.
SO WHAT ARE THE BENEFITS?
PARTICIPANTS MAY RECEIVE
INFORMATION VALUABLE TO THEIR
HEALTHCARE AND LIFE DECISIONS.
WELL, THAT'S PRETTY
STRAIGHTFORWARD AND IMPORTANT.
SECONDLY, PARTICIPANTS WILL FEEL
RESPECTED THROUGH A MORE ROBUST
PARTNERSHIP IN THE RESEARCH
INVOLVING RECIPROCITY AND
TRANSPARENCY.
THESE ARE A LITTLE HARDER TO
MEASURE.
MIGHT THERE BE PRACTICAL
IMPLICATIONS FOR THIS?
MIGHT WE SEE A ENHANCED
RECRUITMENT OR RETENTION IN
RESEARCH?
AND WE ALL KNOW THAT RECRUITMENT
AND RETENTION, I THINK BECOMING
INCREASINGLY CHALLENGING OVER
TIME.
MIGHT THIS HELP PEOPLE DECIDE TO
PARTICIPATE IN STUDIES?
AND, MIGHT IT HAVE A MORE
SIGNIFICANT BACKGROUND EFFECT IN
ENHANCING TRUST IN THE CLINICAL
RESEARCH ENTERPRISE?
EFFICACY FOR CLINICAL RESEARCH
HINGES CRITICALLY ON THE NOTION
OF TRUST.
SO CAN WE BUILD TRUST THROUGH
THIS PRACTICE.
SO HERE'S THE COVER OF THE
REPORT I PARTICIPATED IN IN
2018.
ONE OF THE MOST REWARDING
EXPERIENCES OF MY CAREER.
AND THIS IS THE GROUP OF FOLKS.
I WON'T GO THROUGH THIS TERRIFIC
GROUP OF PEOPLE, BUT JUST
FASCINATING DISCUSSIONS OVER A
ONE-YEAR PERIOD OF TIME TO COME
FORWARD WITH THIS REPORT.
SO I'M GOING TO HIGHLIGHT A
COUPLE OF OUTCOMES FROM THIS
CONSENSUS COMMITTEE.
SO WHAT'S THE BASIC PROPOSED
STANDARD THAT WE WERE TRYING TO
SUPPORT?
THAT INVESTIGATORS AND THE IRB
SHOULD CONSIDER AND PLAN WHETHER
AND HOW TO RETURN RESULTS,
PRIMARY RESULTS OR UNANTICIPATED
RESULTS, ON A
PROTOCOL-BY-PROTOCOL BASIS.
SO A NUMBER OF OTHER
INVESTIGATORS WHO HAVE WORKED IN
THIS AREA HAVE FOCUSED MORE ON
OKAY, WHAT ARE THE CRITERIA THAT
HELP US DECIDE WHETHER OR NOT TO
RETURN INDIVIDUAL RESULTS.
OURS WAS A LITTLE BIT MORE OF A
PROCESS-BASED SET OF
RECOMMENDATIONS.
NOT TO SAY WHAT OUGHT TO BE
RETURNED, BUT HOW YOU SHOULD
ESTABLISH A PROCESS BY WHICH
THOSE DECISIONS ARE MADE.
UNDERSTANDING THAT THE
COMPLEXITIES OF EACH STUDY NEED
TO BE CONSIDERED IN ORDER TO
MAKE A
PROTOCOL-BY-PROTOCOL-BASED
DECISION.
SO IT WAS MORE OF A PROCESS
APPROACH TO THIS.
SO I THINK THOSE TWO DOMAINS ARE
A NICE MARRIAGE OF
CONSIDERATIONS.
NOW, IF RESULTS WILL BE OFFERED
IN SOME OR ALL CIRCUMSTANCES,
CONSENT OF THE PARTICIPANTS
SHOULD BE OBTAINED.
AGAIN, PRETTY BOILERPLATE STUFF.
AND OBVIOUSLY THIS IS EXACTLY
WHAT WE'RE DOING WITH RESPECT TO
THE ECHO STUDY, IS THINKING ON A
PROTOCOL-BY-PROTOCOL BASIS OR
EVEN RESULT-BY-RESULT BASIS
ABOUT WHAT OUGHT TO BE RETURNED.
SO AGAIN A COUPLE OF BASIC
RECOMMENDATIONS THAT I THINK ARE
LARGELY UNASSAILABLE AND AGAIN
REFLECTED SO NICELY IN THE ECHO
PROCESS HERE.
YOU REALLY WANT PARTICIPANT AND
COMMUNITY ENGAGEMENT.
HAVING THE INVESTIGATORS OR
CLINICIANS' POINT OF VIEW ON
WHAT OUGHT TO BE RETURNED IS
INSUFFICIENT.
YOU REALLY NEED TO ENGAGE WITH
THE ACTUAL PEOPLE WHO ARE
PARTICIPATING IN YOUR STUDY TO
HELP GUIDE YOU ON WHAT SORTS OF
INFORMATION PEOPLE WANT, AND HOW
IT IS THAT YOU CAN BEST CONVEY
THAT INFORMATION IN A MEANINGFUL
AND EFFECTIVE WAY.
SO YOU SHOULD SEEK INFORMATION
ABOUT PARTICIPANT VALUES,
RESEARCH INSTITUTIONS, AND WE
TRIED WITH EACH OF THE
RECOMMENDATIONS TO SORT OF GO
THROUGH THE DIFFERENT INTEREST
GROUPS AND HELPING EACH OF THEM
DECIDE WHAT THEIR ROLE WOULD BE.
SO RESEARCH INSTITUTIONS AND
SPONSORS SHOULD FACILITATE
INVESTIGATOR ACCESS TO RELEVANT
COMMUNITY AND PARTICIPANT
GROUPS.
EACH INVESTIGATOR MAY NOT HAVE
THE KNOWLEDGE, BACKGROUND,
ABILITY TO SIMPLY ENGAGE WITH
THE COMMUNITY.
WHAT DOES THAT MEAN?
HOW DO YOU DO THAT IN THE RIGHT
WAY?
SO INSTITUTIONS OUGHT TO BE ABLE
TO FACILITATE THAT AND THEN
SPONSORS LIKE THE NIH SHOULD
ENGAGE COMMUNITY AND PARTICIPANT
REPRESENTATIVES IN THE
DEVELOPMENT OF POLICY AND
GUIDANCE IN THIS PARTICULAR
AREA.
AGAIN, EXACTLY AS YOU'RE DOING.
SO HERE'S OUR GENERAL FRAMEWORK.
I THINK FOLKS CAN SEE THAT
PRETTY WELL.
WITH THE NOTION THAT
JUSTIFICATION FOR RETURN BECOMES
STRONGER AS THE POTENTIAL VALUE
OF THE RESULTS TO PARTICIPANTS
AND THE FEASIBILITY OF RETURN
INCREASES.
SO IF YOU'VE GOT LOW FEASIBILITY
AND LOW VALUE, WEAK
JUSTIFICATION, HIGH FEASIBILITY,
STRONG VALUE, STRONG
JUSTIFICATION AND OF COURSE
CONTROVERSIAL AREAS ARE GOING TO
BE IN THOSE CORNERS WHERE YOU
HAVE LOW FEASIBILITY BUT HIGH
VALUE OR POTENTIALLY HIGH
FEASIBILITY BUT LOW VALUE.
AND THAT'S WHERE THE DEBATES ARE
GOING TO BE MORE DIFFICULT.
I'M GOING TO CRITIQUE THIS FAME
WORK HERE IN AFRAMEWORK FOR YOUD
HERE.
SO WHAT ARE SOME OF THE
CONTROVERSIES AND UNCERTAINTIES
FROM MY PERSPECTIVE?
FIRST IS THE NOTION OF
FEASIBILITY.
HOW MUCH BURDEN ON THE RESEARCH
ENTERPRISE IS ACCEPTABLE FOR
THIS GOAL?
AGAIN, UNDERSTANDING THAT THIS
IS HARD, REQUIRES A LOT OF MAN
WORK, RESOURCES, DEVELOP
COMMUNICATION STRATEGY, ARE THEY
EFFECTIVE OR NOT.
RETURN OF RESULT REQUIRES
MAINTAINING IDENTITIES AND
CONTACT INFORMATION.
A LOT OF THE RESEARCH IN
GENETICS, FOR EXAMPLE, HAS BEEN
DONE WITH BIOBANKS WHERE PEOPLE
HAVE BEEN EITHER DE-IDENTIFIED
OR ANONYMIZED, SO THAT'S A WAY
OF PROTECTING THEIR IDENTITIES
AND, THEREFORE, PROTECTING THEIR
PRIVACY IN THAT FASHION.
SO IS IT A RISK TO PRIVACY TO
MAINTAIN CONTACT INFORMATION FOR
THE PURPOSES OF RETURNING
RESULTS?
PROJECTS MAY END BEFORE THE
MEANING OF THE RESULTS ARE
CLEAR.
ONE OF THE THINGS IN OUR
CONSENSUS STATEMENT CONSISTENT
WITH MANY OTHER GROUPS IS THAT
YOUR OBLIGATION TO RETURN
RESULTS PROBABLY ENDS WITH THE
END OF YOUR PROJECT.
AND THEN IT'S NOT REASONABLE TO
TRY TO MAINTAIN SOME SORT OF
FUNDING AND LINE AND SET OF
ACTIVITIES TO RETURN RESULTS
ONCE THE PROJECT IS OVER.
WELL, PROJECT MAY WELL BE OVER
FROM A FUNDING STANDPOINT BEFORE
YOU REALLY UNDERSTAND WHAT THE
RESULTS ARE OR BEFORE THEY'VE
BEEN CONFIRMED BY SUBSEQUENT
RESEARCH.
AND HOW ABOUT THE VALUES TO
PARTICIPANTS, THAT OTHER AXIS?
THE DIAGRAM DOESN'T INCLUDE
DISVALUE OR HARM TO
PARTICIPANTS.
YOU NOTICE ON THE LEFT SIDE THAT
VALUE GOES FROM HIGH TO ZERO.
WELL, IT PROBABLY -- WE SHOULD
HAVE PROBABLY EXTENDED THAT AXIS
IN THE OTHER DIRECTION TO SAY
THERE MAY BE CIRCUMSTANCES WHERE
PEOPLE GET HARMED BY THIS.
AND SO HOW DO YOU THEN ASSESS
THAT?
I DON'T THINK WE KNOW YET.
EARLY IN THE L.C. FIELD, WE'RE
VERY CONCERNED ABOUT PREDICTIVE
GENETIC INFORMATION AND THE
NEGATIVE IMPACT ON PEOPLE.
I THINK WHAT THAT RESEARCH
SHOWED WAS THAT WE OVERESTIMATED
THE IMPACT OF CONCERNING
INFORMATION.
NOT THAT IT WASN'T IMPACTFUL FOR
PEOPLE, BUT FROM A PSYCHOLOGICAL
STANDPOINT, IT WASN'T HARMFUL.
AND IT'S UNCERTAIN INFORMATION
THAT'S PROBABLY MORE
PROBLEMATIC, WHEN PEOPLE CAN'T
GRAPPLE WITH INFORMATION THAT
THEY CAN'T REALLY UNDERSTAND.
SO IN THIS PARTICULAR CONTEXT, I
THINK ANTICIPATING INFORMATION
ABOUT UNCERTAIN ENVIRONMENTAL
HEALTH RISKS TO A FETUS OR CHILD
COULD BE HIGHLY IMPACTFUL FOR
PREGNANT WOMEN AND COUPLES.
CLINICAL UTILITY IS A STRONG
VALUE BUT SHOULD IT BE BASED ON
WHETHER PARTICIPANTS CAN USE
INFORMATION OR DO USE IT?
WE NEED -- AND LASTLY PERSONAL
UTILITY, HOW TO DETERMINE WHERE
THESE TYPES OF USES FALL ON THE
VALUE SPECTRUM.
PEOPLE MAY FIND, YEAH, I WANT TO
KNOW THAT INFORMATION, IT'S GOOD
FOR ME TO KNOW, BUT THEY'RE NOT
GOING TO USE IT FROM A CLINICAL
STANDPOINT.
ALL RIGHT.
ALMOST ON TIME.
SO THANK YOU.
AND I GUESS QUESTIONS NOW.
>>PLEASE RAISE YOUR HAND IF YOU
HAVE A QUESTION.
>>THANK YOU.
THAT WAS GREAT TO GET AN INSIGHT
INTO THAT PROCESS.
ONE OF THE THINGS THAT I THINK
WE OFTEN DO IS WE MAKE
PARTICIPANTS SEPARATE FROM WHO
WE ARE, AND WE DON'T HAVE THAT
SENSE THAT PARTICIPANTS COME
FROM COMMUNITIES AND REPRESENT
THE SAME VALUES THAT A LOT OF
THE RESEARCHERS HOLD AS WELL,
AND PART OF THAT WHOLE TRAINING
OF THE RESEARCH AND CLINICAL
ENTERPRISE IS ALSO THIS CONCEPT
THAT BECAUSE PARTICIPANTS ARE
DIFFERENT, THEY CAN'T POSSIBLY
DEAL WITH UNCERTAINTY.
AND THAT'S DRILLED IN ALL THE
WAY THROUGH, AND SO WHEN YOU GET
TO THE POINT WHERE THERE'S
UNCERTAINTY, THEN THAT BECOMES
THE WALL.
AND I THINK EXPERIENTIALLY, WHAT
I'VE SEEN, ANYWAY, IS THAT IF
YOU'RE OPEN ALL THE WAY THROUGH,
PEOPLE DO UNDERSTAND
UNCERTAINTY.
AND THEY KNOW THAT YOU DON'T
ALWAYS KNOW THE RESULTS, BUT AT
LEAST THEY KNOW TO KEEP WATCHING
IN THE FUTURE IF A STUDY ENDS.
SO I JUST WONDERED IF THAT
DISCUSSION HAPPENED IN THE
PROCESS AND IF YOU COULD COMMENT
ON THAT.
>>I THINK THAT'S AN EXCELLENT
POINT.
I WOULD DEFER TO OTHERS WHO
PROBABLY HAVE MORE EXPERIENCE
ABOUT THOSE KINDS OF DISCUSSIONS
BUT I THINK THAT'S AN EXCELLENT
POINT.
AND IF YOU MAKE IT A PROCESS TO
ENGAGE PEOPLE EARLY AND
HIGHLIGHT THE UNCERTAIN NATURE
OF THE RESEARCH ENTERPRISE AND
THE RESULTS, THEN THAT PROBABLY
HELPS SUPPORT PEOPLE TO HELP
THEM EFFECTIVELY UNDERSTAND AND
ENGAGE THROUGH THE WHOLE
PROCESS.
I'LL ALSO SAY FROM MY
PERSPECTIVE, PART OF THE
CHALLENGE, THIS IS PART OF OUR
EARLIER RESEARCH AROUND NEGATIVE
RESULTS FROM GENETIC --
PREDICTIVE GENETIC TESTING
STUFF, I THINK WE FIND THAT FOR
MANY CIRCUMSTANCES, THE MAJORITY
OF PEOPLE DO JUST FINE.
BUT THEN THERE'S THIS SUBSET OF
FOLKS WHO ARE MORE SENSITIVE FOR
A VARIETY OF REASONS, MORE
SENSITIVE PSYCHOLOGICALLY, FROM
THEIR LIFE CIRCUMSTANCES, ET
CETERA, AND THAT THOSE MAY BE
THE PEOPLE WHO, SMALL IN NUMBER
BUT YET YOU'RE GOING TO HAVE
MUCH MORE IMPACT BECAUSE OF THE
NATURE -- IF YOU CAN PREDICT
THAT, THEN YOU CAN GO IN WITH
SOME HELP BUT YOU MAY NOT BE
ABLE TO PREDICT THAT, SO PART OF
THE ETHICAL CHALLENGE IN THIS
DOMAIN IS NOT NECESSARILY TO SAY
WHAT'S THE AVERAGE RESEARCH
PARTICIPANT WANT, BUT ARE THERE
SOME GROUPS THERE THAT FOR
WHATEVER REASON ARE MORE
SENSITIVE AND WE NEED TO FOCUS
OUR EFFORTS ON TO MAKE SURE THAT
THAT GROUP DOES WELL IN THE
PROCESS, IN ADDITION.
>>IS THERE A THRESHOLD TO THE
INFORMATION YOU'RE WILLING TO
DISCLOSE?
>>ANY THRESHOLD?
>>YES.
>>I THINK PROBABLY THE
THRESHOLD I WOULD POINT TO IS
JUST THE SORT OF THING THAT
COMES OUT OF THAT RUBRIC, WHICH
IS TO SAY INFORMATION THAT HAS
NO PERCEIVED VALUE FOR PEOPLE IS
PROBABLY A THRESHOLD.
NOW, MAYBE THAT'S ALL A SLIDING
SCALE AND THERE'S NO REAL BRIGHT
LINES THERE, BUT IF YOU REALLY
HAVE INFORMATION THAT NOBODY CAN
INTERPRET AND HAS NO MEANING TO
PEOPLE, THEN THAT'S PROBABLY
FALLING BELOW A THRESHOLD THAT I
WOULD SAY I WOULDN'T SPEND TIME,
RESOURCES AND EFFORT TO TRY TO
COMMUNICATE.
AND THERE MAY WELL BE THINGS IN
THE ENVIRONMENTAL HEALTH FIELD,
FOR EXAMPLE, THAT YOU'RE
COLLECTING DATA BECAUSE IT'S
GOING TO BE
HYPOTHESIS-GENERATING DOWN THE
LINE, AND WHAT'S THE MICROBIOME
OF THE GUT LOOK LIKE?
WELL, IS THAT SOMETHING THAT
PEOPLE CAN INTERPRET AND NEED TO
KNOW?
YOU KNOW, MAYBE NOT.
BUT MAYBE A SCIENTIST DOWN THE
ROAD FROM PULL FROM THAT DATA
AND DRAW SOME TENTATIVE
ASSOCIATION CONCLUSIONS THAT
WOULD BE USEFUL FROM A RYE A REH
STANDPOINT BUT HAVE NO MEANING
TO A PARTICULAR INVESTIGATOR.
SO JUST KIND OF PULLING OUT OF
MY HAT SOMETHING THAT I THINK
MIGHT FALL BELOW THAT SORT OF
THRESHOLD.
BUT IN GENERAL, I THINK ANYTHING
THAT'S CONSIDERED A RESULT OUGHT
TO BE CONSIDERED FOR RETURN, AND
THEN NO THRESHOLD IN THAT
REGARD.
>>ANOTHER QUELL?
QUESTION?
>>YES.
THERE'S A QUESTION FROM THE ZOOM
AUDIENCE.
UNDER WHAT CIRCUMSTANCES DO YOU
NOT RETURN RESULTS TO INDIVIDUAL
PARTICIPANTS?
SEEMS IDENTICAL TO FULL
DISCLOSURE, PARTICIPANTS VERY
INDIVIDUAL DATA, I DON'T THINK
THE RESEARCHERS SHOULD DECIDE
ABOUT THE VALUE OF THE RETURNED
DATA.
THEY SHOULD RETURN RESULTS,
OBSERVING CONFIDENTIALITY OF THE
PARTICIPANT.
>>I THINK THAT'S GOING TO BE
THE WHOLE DISCUSSION WE HAVE
OVER THE NEXT COUPLE DAYS AND
THAT THE COMMITTEE AND STUDY IS
GOING TO HAVE AN ONGOING BASIS.
I PROBABLY WOULDN'T CONCLUDE
A PRIORI THAT ALL RESULTS SHOULD
ON WILL BE RETURNED FROM MY
PERSPECTIVE, I THINK IT'S A
MATTER OF THINKING THROUGH EACH
RESULT IN A PARTICULAR CONTEXT
THAT YOU'RE WORKING WITH, IN
COLLABORATION WITH THE FAMILIES.
AND I THINK WHEN PEOPLE
UNDERSTAND, AND THAT'S BEEN MY
EXPERIENCE WITH DOING DOING REH
WITH PARTICIPANTS, WHEN YOU GIVE
THEM SORT OF A BROAD
UNDERSTANDING OF WHAT THE
LEGITIMATE TRADEOFFS ARE, FOLKS
WILL SAY OKAY, I GET IT, MAYBE
IT'S NOT RIGHT FOR ME TO JUST
SAY I WANT EVERYTHING, GIVE ME
EVERYTHING.
PEOPLE UNDERSTAND THERE ARE
LEGITIMATE TRADEOFFS THERE THAT
THEY SAY OKAY, LET'S THINK ABOUT
WHAT'S MOST MEANINGFUL FOR ME
AND MY FAMILY AND LET'S WORK
TOGETHER TO DO THIS IN THE RIGHT
WAY.
>>OKAY, THANKS, JEFF.
I THINK FOR THE PURPOSES OF
TIME, WE'LL MOVE ON TO THE NEXT
SPEAKER.
THAT WILL BE DR. KYLE BROTHERS.
>>GREAT.
THANK YOU SO MUCH FOR HAVING ME
THIS MORNING.
I'M GOING TO CONTINUE THE WORK
THAT JEFF STARTED, TALK ABOUT
ETHICAL PRINCIPLES THAT ARE
RELEVANT HERE.
AND THINK OF THIS AS SORT OF
PUTTING SOME LANGUAGE AND IDEAS
INTO THE ROOM.
I'M NOT GOING TO SOLVE ANY
PROBLEMS HERE BUT HOPEFULLY GIVE
US SORT OF A STARTING PLACE TO
THINK ABOUT THE LANGUAGE THAT WE
CAN USE IN TALKING THROUGH SOME
THIEVES ISSUES.
OKAY.
I WANT TO MAKE A DISTINCTION.
THIS IS SIMILAR TO THE
DISTINCTION JEFF MADE BUT I
THINK IT'S REALLY HELPFUL TO
THINK ABOUT TWO DIFFERENT
CONTEXTS WHERE WE MIGHT HAVE A
RESULT THAT INVESTIGATOR IS
THINKING ABOUT MAYBE THESE
SHOULD BE RETURNED TO
PARTICIPANTS.
THE FIRST IS, YOU KNOW, A STUDY
DESIGNED PROSPECTIVELY WITH A
PLAN TO RETURN CERTAIN RESULTS.
SO SOUNDS LIKE THIS NEXT STAGE
OF ECHO HOPEFULLY WILL BE THIS
KIND OF PROJECT.
SO THE MOTIVATION FOR THIS
REALLY HAS TWO ELEMENTS TO IT.
THERE IS AN INHERENT VALUE TO
THIS, RIGHT?
IT DEMONSTRATES TRANSPARENCY AND
RECIPROCITY.
THERE'S NO OUTRIGHT BENEFIT TO
THE INVESTIGATOR, TO THE
RESEARCH, BY DOING THIS.
OF IT'S JUST RIGHT THING TO DO,
RIGHT?
ETHICS IS REALLY INTERESTED IN
THE RIGHT THING TO DO.
THERE'S ALSO SEPARATE BUT NOT
CONFLICTING VALUE THAT IS
INSTRUMENTAL THAT HAS AN EFFECT
THAT'S BENEFICIAL, AND THAT
COULD BE SORT OF AN INCENTIVE TO
ENCOURAGE PARTICIPANTS TO REMAIN
ENGAGED WITH THE STUDY.
SORT OF AGREED TO PARTICIPATE,
CALL THEM IN THREE MONTHS AND
GET MORE INFORMATION OR MAYBE
HAVE THEM COME IN TO COLLECT
ANOTHER BIO SAMPLE.
WE WANT FOLKS TO FEEL THAT THIS
PARTNERSHIP IS VALUABLE TO THEM
AND THEY WANT TO CONTINUE TO
PARTICIPATE, SO THIS CLEARLY HAS
AN INSTRUMENTAL VALUE TO THE
RESEARCH THAT ALLOWS YOU TO
SUCCESSFULLY CARRY OUT THE
RESEARCH.
AND IN THIS KIND OF STUDY, THE
RESULT IS GENERATED FOR
PARTICIPANT AND MANAGED TO BE A
STUDY MOL SEE.
THIS IS HOW WE LAN D HANDLE IT.
WE CAN ALSO THINK ABOUT A
DIFFERENT KIND OF RESULT.
A FINDING THAT IS DISCOVERED AND
THOUGHT TO HAVE POTENTIAL
IMPLICATIONS FOR A RESEARCH
PARTICIPANT BUT ITS EXPERIENCE
IS A SURPRISING EVENT.
WE COLLECTED THESE SAMPLE WITH
NO SPECIFIC IDEA ABOUT WHAT KIND
OF RESEARCH WAS GOING TO BE DONE
AND THEN A YEAR, TWO, 10 YEARS
LATER, WE DISCOVER SOMETHING
ABOUT A BIOSAMPLE THAT WAS
COLLECTED OR ABOUT THE DATA THAT
WAS COLLECTED THAT ALL OF A
SUDDEN, WHOA, THIS SEEMS LIKE
IT'S GOING TO BE REALLY
IMPORTANT FOR A PERSON TO KNOW,
AND WE SORT OF EXPERIENCE THIS
AS A SURPRISE, THERE WAS NO PLAN
FOR THIS.
A KEY POINT I WANT TO MAKE IS
THAT SOME STUDIES WILL WANT TO
RETURN SURGEON RESULTS AND OF
COURSE THEY NEED A POLICY FOR
HOW TO DO THAT.
THAT'S WHAT WE'RE HERE FOR.
BUT ALL STUDIES SHOULD ALSO PLAN
A PROCESS FOR HOW THEY WILL
HANDLE UNEXPECTED RESULTS.
THAT IS INEVITABILITY OF MODERN
RESEARCH AND WE REALLY NEED TO
THINK ABOUT BOTH, BUT PROBABLY
EXISTS ON A SPECTRUM.
THERE ARE SOME THINGS THAT ARE
WELL PLANNED, SORT OF LIKE WE
KNEW BUT MAYBE WE DIDN'T PLAN
SPECIFICALLY.
AND THEN THERE ARE THINGS THAT
ARE REALLY PURE SURPRISE.
SO THIS IS A SPECTRUM AND WE
SORT OF NEED TO THINK ABOUT THAT
WHOLE RANGE.
OKAY.
FOR THE PURPOSES OF TALKING
ABOUT ETHICAL PRINCIPLES, I
THINK IT'S HELPFUL TO KIND OF
DICHOTOMIZE THESE AND THINK
ABOUT WHAT ARE THE PRINCIPLES
THAT GO ALONG WITH A PLANNED
RETURN OF RESULTS STRATEGY.
SO THE TWO KEY ISSUES YOU'VE
HEARD USED ALREADY A BIT THIS
MORNING, THE FIRST ONE IS
RECIPROCITY.
WHICH IS REALLY -- IT'S A
SITUATION IN WHICH TWO GROUPS
AGREE TO HELP EACH OTHER OUT BY
EXCHANGING ADVANTAGES AND
HOPEFULLY THOSE ADVANTAGES ARE
PROPORTIONAL.
IT'S NOT EXTRACTIVE IN SOME WAY
THAT I GET SOMETHING FROM YOU
BUT YOU DON'T GET ANYTHING FROM
ME.
BUT RATHER WE'RE EXCHANGING
PROPORTIONAL ADVANTAGES.
I BENEFIT, YOU BENEFIT, WE'RE
BOTH HAPPY WITH THAT EXCHANGE.
THE NEXT IS TRANSPARENCY, WHICH
IS SIMPLY A WAY OF DOING THINGS
IN AN OPEN WAY WITHOUT SECRETS.
THIS IS -- IT'S REALLY HELPFUL
TO THINK ABOUT THIS TERM ON ITS
OWN BECAUSE IT GETS THROWN
AROUND A LOT, AND WE MAYBE DON'T
HESITATE TO STOP AND JUST THINK
ABOUT WHAT DO WE REALLY MEAN
THERE.
BUT A KEY THING ABOUT
TRANSPARENCY IS THE UNDERLYING
ETHICAL PRINCIPLE OF TRUTH
TELLING, RIGHT?
KEEPING INFORMATION THAT I DON'T
TELL SOMEONE ELSE ABOUT THEM
COULD BE PERCEIVED AS A LIE,
RIGHT?
I DIDN'T TELL YOU THE TRUTH
ABOUT WHAT I KNOW ABOUT YOU,
YOUR HEALTH, YOUR ENVIRONMENTAL
EXPOSURES, ET CETERA.
SO CLASSIC ETHICS PRINCIPLES
THAT COME UP IN RESEARCH AND IN
CLINICAL PRACTICE ARE THESE
TERMS WHICH WE DON'T NEED TO USE
THESE TWO DAYS, BUT IT IS GOOD
TO THINK ABOUT THEM.
THE FIRST ONE IS BENEFICENCE,
WHICH IS SORT OF THE OPPORTUNITY
TO DO GOOD, PRODUCE GOOD FOR
PEOPLE.
AND THEN IT'S SORT OF FLIPSIDE,
IN ETHICS WE CALL IT
NONMALFEASANCE OR AVOIZ AVOIDIN.
WE WANT TO UNDUE THEM AND ALSO
PREVENT HARMS THAT COULD OCCUR.
SOMETHING I REALLY WANT TO
EMPHASIZE AND I HOPE WE CAN KEEP
THIS IN THE ROOM AS WE DISCUSS
THESE ISSUES, WE'RE OFTEN
ENTHUSIASTIC ABOUT THE POTENTIAL
OF OUR SCIENCE TO HELP PEOPLE.
THAT'S WHY WE DO IT, RIGHT?
SO SCIENTISTS REALLY BELIEVE THE
WORK THEY DO IS GOING TO HELP
PEOPLE, THAT'S WHAT DRIVES THEIR
DAY TO DAY WORK.
BUT BECAUSE OF THAT INVESTMENT,
IT SOMETIMES EASY TO SEE
POTENTIAL BENEFITS AND WE REALLY
STRUGGLE TO ANTICIPATE THE
HARMS.
BECAUSE WE ARE FOCUSED ON THE
BENEFITS.
THAT'S WHAT WE WANT TO GET OUT
OF THIS.
BUT SOMETIMES WE DON'T
ANTICIPATE THOSE HARMS.
SO ONE EXAMPLE COULD JUST BE
TRYING TO GET A LITTLE CONCRETE
HERE, LET'S SAY WE'RE MONITORING
INDOOR AIR QUALITY ACROSS A
COHORT OF PEOPLE, AND WE
DISCOVER CERTAIN PEOPLE HAVE
SOME KIND OF EXPOSURE IN THEIR
HOUSE AND WE THINK, OH, TELLING
THEM ABOUT THAT WOULD BE REALLY
IMPORTANT.
SO THEN THOSE FOLKS GO OUT AND
MAYBE GET AIR FILTERS OR OTHER
KINDS OF TECHNOLOGIES, AND YOU
COULD IMAGINE TWO KINDS OF HARMS
RESULTING FROM THAT.
ONE IS THAT THAT AIR FILTER
ACTUALLY DOESN'T SUCCEED IN
FILTERING OUT THE EXPOSURE, SO
WE'VE NOW EXPENDED A COST TO GET
THIS DEVICE, BUT IT ACTUALLY
DOESN'T CREATE ANY BENEFIT.
THE OTHER POSSIBILITY IS THAT
EXPOSURE, ALTHOUGH OUR SCIENCE
TOLD US IT MIGHT CAUSE HARM,
ACTUALLY DOESN'T CAUSE ANY HARM.
AND SO WE BELIEVED OVER A PERIOD
OF TIME THAT WE WERE TAKING
THESE STEPS TO PROTECT OURSELVES
AND WE NEVER NEEDED TO PROTECT
OURSELVES IN THE FIRST PLACE,
RIGHT?
SO I ACTUALLY DON'T THINK THAT
BIGGEST PROBLEM HERE IS THAT
PARTICIPANTS WILL BE CONFUSED OR
THEY WILL BE -- THEY'LL NOT
UNDERSTAND WHAT THEY'RE TOLD,
BUT RATHER THAT WE WILL RETURN
INFORMATION FOCUSED ON THE
POTENTIAL BENEFIT WITH
INSUFFICIENT ATTENTION TO WHAT
ARE THE UNEXPECTED HARMS THAT
COULD OCCUR.
OKAY.
I THINK SEVERAL SPEAKERS ARE
GOING TO GO INTO THIS IN MORE
DEPTH BUT I JUST WANTED TO MAKE
IT VERY CLEAR THAT INTEREST IN
RECEIVING RETURN OF RESULTS IS
TYPICALLY VERY HIGH.
SOME OF YOU HAVE ALREADY
COMMENTED ABOUT THAT, AND IT'S
REALLY CLEAR MOST PEOPLE, IF YOU
SAY DO YOU WANT INFORMATION THAT
COULD BE IMPORTANT TO YOUR
HEALTH AND WELLNESS, PEOPLE WILL
SAY, HELL, YEAH, I WANT THAT,
RIGHT?
THE WILLINGNESS TO PARTICIPATE
IN RESEARCH FROM THE VERY
BEGINNING CAN BE INFLUENCED BY
THE OFFER OF RETURN OF RESULTS.
SO IF WE LOOK AT WILLINGNESS TO
PARTICIPATE IN RESEARCH, DO YOU
WANT TO PARTICIPATE IN THE
STUDY, WE'RE NOT GOING TO GIVE
YOU ANYTHING, DO YOU WANT TO
PARTICIPATE IN THIS STUDY, WE'LL
GIVE YOU SOME STUFF, THE PEOPLE
WHO RECEIVE AN OFFER WITH RETURN
OF RESULTS ARE MUCH MORE LIKELY
TO AGREE TO PARTICIPATE.
BUT WHEN WE LOOK AT AFTER THE
FACT, THIS IS SPECIFIC TO
GENETICS, AND TALK TO FOLKS
ABOUT HOW DID YOU FEEL ABOUT THE
INFORMATION THAT YOU RECEIVED
FROM US, THEY WILL OFTEN EXPRESS
DISAPPOINTMENT ABOUT HOW LITTLE
INFORMATION THEY ACTUALLY
RECEIVED.
WHEN WE USE THE WORD WHOLE IN
WHOLE GENOME SEQUENCING, FOLKS
EXPECT TO GET A TON OF
INFORMATION.
HOWEVER, IF WE DON'T HAVE A
PROCESS WHERE WE'RE SORT OF
RETURNING ALL OF THE
INFORMATION, LIKE THE PERSON
ASKING THE QUESTION IN THE LAST
SPEECH, AND WE'RE SORT OF LIKE
FILTERING THAT AND TRYING TO
FIND THINGS THAT ARE BENEFICIAL,
PEOPLE WILL BE DISAPPOINTED AT
HOW MUCH INFORMATION THEY GET.
AND THE QUESTION COULD BE, DID
WE SET UNRULES UNREALISTIC EXPS
IN THE BEGINNING, ESPECIALLY
DURING THE ENROLLMENT PROCESS,
WE WANT TO KATION A FAVORABLE
LIGHT, DID WE GO OVERBOARD AND
SET UNREALISTIC EXPECTATIONS?
SO WE REALLY NEED TO TAKE CARE
WITH THAT KIND OF ISSUE.
AND WE'VE ALREADY SAID BOTH
INVESTIGATORS AND FOLKS WHO
RECEIVE INFORMATION MIGHT
STRUGGLE WL UNCERTAINTY, THEY
MIGHT OIFER INTERPRET TO HAVE
MEANING THAT REALLY DOESN'T
EXIST.
UNFORTUNATELY WHEN A SCIENTIST
OR ESPECIALLY A CLINICIAN TELLS
A PERSON A PIECE OF INFORMATION,
THEY ASSUME IT HAS A LEVEL OF EU
TILL AND VALIDITY THAT MAY BE
UNJUSTIFIED, RIGHT, ESPECIALLY
WHEN IT'S SORT OF A NEW KIND OF
SCIENTIFIC FINDING.
SO OVERINTERPRETATION ON BOTH
SIDES IS A POSSIBILITY AND OF
COURSE WE ALL STRUGGLE WITH
ACCOMMODATING NEW UNCERTAIN
INFORMATION.
SO PRINCIPLE 2 THAT I WANT TO
PUT INTO THE ROOM, ANY EFFORT TO
RETURN INDIVIDUAL RESEARCH
RESULTS SHOULD BE BASED ON
EVIDENCE ABOUT WHAT WILL PRODUCE
BENEFITS THAT OUTWEIGH HARMS.
I'M GOING TO GET INTO THIS NEXT.
FIRST AND FOREMOST, RESEARCHERS
MUST ACHIEVE THE AIMS OF THEIR
PROFESSION, RIGHT?
TO PROVIDE BENEFIT TO SOCIETY BY
GENERATING NEW KNOWLEDGE AND TO
JUSTIFY THE RISKS THAT WERE
TAKEN BY RESEARCH PARTICIPANTS
BY LETTING THEIR INFORMATION AND
BIOSAMPLES BE COLLECTED.
SO IF WE DON'T PROVIDE A BENEFIT
TO SOCIETY, THEN WE DIDN'T
JUSTIFY THE RISK THAT THE
PARTICIPANTS TOOK ON BY AGREAING
TO PARTICIPATE.
SO WE REALLY NEED TO MAKE SURE
THE SCIENCE LEADS TO THE VALUE
THAT WAS HOPED FOR.
SO AGAIN, RESEARCHERS MUST NOT
PURSUE RETURN OF RESULTS AT THE
COST OF SCIENTIFIC BENEFIT.
BUT RETURN OF RESULTS AND
ACHIEVING SCIENTIFIC BENEFIT CAN
ACTUALLY WORK TOGETHER TO
MAXIMIZE BENEFIT TO THE
PARTICIPANTS AND TO SOCIETY, BUT
WE JUST NEED TO ORGANIZE OUR
APPROACH SO THAT THOSE THINGS
ARE SYNERGISTIC, NOT IN CONFLICT
WITH ONE ANOTHER.
AND SO UNDERLYING THAT PRINCIPLE
IS REALLY THE IDEA THAT A
CENTRAL ELEMENT OF ANY RETURN OF
RESULTS PLAN MUST BE AN
ASSESSMENT OF OPPORTUNITY COSTS.
WE CAN DO THIS RETURN OF RESULTS
THING THAT WILL CARRY A COST TO
EVERYTHING ELSE THAT WE'RE DOING
AND WE NEED TO BALANCE THE PROS
AND CONS OF THAT.
OKAY.
SO ANOTHER IMPORTANT TOPIC TO
THINK ABOUT IS THE FUTURE
DIRECTION FOR RESEARCH IN THIS
AREA.
SO AS YOU CAN IMAGINE, BENEFIT
AND HARM FROM RETURNING RESULTS
CAN ITSELF BE A MEASURABLE KIND
OF THING, AND IN FACT, IT CAN BE
ITSELF A HIGHLY VALUABLE PART OF
OUR RESEARCH.
SO IF WE'RE LOOKING AT A
PARTICULAR EXPOSURE LIKE HEAVY
METALS IN OUR WATER SUPPLY OR
SOMETHING LIKE THAT, MAYBE WE'VE
NEVER HAD AN OPPORTUNITY TO
EVALUATE WHETHER INFORMATION
LIKE THAT IS USEFUL TO PEOPLE,
AND SO ACTUALLY STUDYING, WE
GAVE TO PEOPLE AND FOUND OUT
WHETHER IT IS HELPFUL TO THEM.
THAT IS A HIGHLY VALUABLE TYPE
OF RESEARCH, AND COULD AND
SHOULD, I THINK, BE INCORPORATED
INTO RETURN EVER RESULTS KINDS F
EFFORTS IN LARGE STUDIES LIKE
THIS.
YOU CAN THINK ABOUT
EVIDENCE-BASED MEDICINE WHICH IS
SORT OF IF WE DO AN INTERVENTION
IN A MEDICAL SETTING, DOES THAT
CARRY A BENEFIT THAT OUTWEIGHS
THE HARMS AND MAYBE DOES THAT
BENEFIT BEAT OUT THE BENEFITS OF
THE OTHER ALTERNATIVES THAT WE
HAD?
SO I THINK WE SHOULD REALLY
THINK ABOUT CAN WE BUILD A FIELD
OF RESEARCH FOCUSED ON
EVIDENCE-BASED ENVIRONMENTAL
REPORT-BACK THAT WE ARE DOING
THIS PRACTICE OF REPORTING
ENVIRONMENTAL INFORMATION TO
FOLKS, MAYBE OTHER KINDS OF
INFORMATION, AND WE WANT TO
BUILD AN EVIDENCE BASE ABOUT
WHAT'S BENEFICIAL AND WHAT'S
NOT.
AND THEN WE CAN ALSO DO RESEARCH
TO BETTER UNDERSTAND PARTICIPANT
PERSPECTIVES ON NON-CLINICAL
TYPES OF INFORMATION.
SO THERE'S BEEN A LOT OF
RESEARCH ON WHAT FOLKS THINK
ABOUT GENETICS TYPE OF RESULTS
IN THEIR RESEARCH PARTICIPATION.
SO WHAT ABOUT OTHER TYPES, WHAT
DO PEOPLE THINK ABOUT THAT KIND
OF INFORMATION?
OKAY.
I JUST QUICKLY WANT TO TALK
ABOUT THIS UNEXPECTED RETURN OF
RESULTS, THE SORT OF THING THAT
WE DISCOVERED LATER ON AND WERE
SURPRISED BY IT AND NOW WE'RE
ASKING THE QUESTION, SHOULD WE
GIVE IT BACK TO THE PARTICIPANTS
EVEN THOUGH WE DIDN'T TALK WITH
THEM ABOUT THAT POSSIBILITY?
AND THE KEY ETHICAL PRINCIPAL
HERE IS WHAT'S CALLED DUTY TO
RESCUE.
SO DUTY TO REESE REST QUEUE
TYPICALLY MEANS A PERSON IN A
PARTICULAR CONTEXT HAS A DUTY TO
TAKE AN ACTION TO PROTECT
ANOTHER PERSON FROM HARM.
AND THE CLASSIC EXAMPLE IN
ETHICS IS LIKE I'M WALKING BY A
POND AND A CHILD FALLS INTO THE
POND, DO I HAVE A DUTY AS A
STRANGER TO JUMP IN THE WATER
AND GO RESCUE THAT PERSON,
RIGHT?
SO THAT'S A CLASSIC EXAMPLE.
THE DUTY TO RESCUE EXISTS ON A
SPECTRUM.
IT'S NOT EITHER I HAD THE DUTY
OR I DON'T, BUT RATHER, THERE
ARE DUTIES THAT GET STRONGER AND
WEAKER DEPENDING ON THE CONTEXT.
SO THE PERSON AT RISK IS READILY
IDENTIFIABLE SORT OF I KNOW WHO
THIS IS, I CAN IDENTIFY THEM AND
GO FIND THEM.
THE HARM IS HIGHLY FORESEEABLE.
THIS IS A KEY ISSUE BECAUSE AT
TIMES WE HAVE A PIECE OF
INFORMATION, WE KNOW THAT IT CAN
BE A RISK, BUT MAYBE WHAT WE
CALL IN GENETICS THE PENETRANCE,
THE CHANCE OF THAT LEADING TO A
RISK ARE LOW SO MAYBE THE
OUTCOME THAT A THING WILL
ACTUALLY HAPPEN IS NOT HIGHLY
FORESEEABLE.
A DUTY ONLY EXISTS IF THERE'S NO
ALTERNATIVE METHOD FOR
PREVENTING THAT HARM.
AND TO BE REALLY CLEAR, THE HARM
HAS TO BE PREVENTABLE.
THERE'S NO DUTY TO JUMP INTO A
POND TO RESCUE A CHILD WHO HAS
UNFORTUNATELY ALREADY DIED, SO
YOU HAVE TO BE ABLE TO PREVENT
THE HARM IN ORDER FOR THERE TO
BE A DUTY.
I JUST WANTED TO MENTION THIS
BECAUSE IT'S A REALLY GOOD
EXAMPLE FROM THE HISTORY OF
ETHICS CALLED THE TARASOFF DUTY,
BASICALLY THE DUTY OF A
PSYCHOTHERAPIST WHO IS TOLD BY A
CLIENT THAT THEY ARE GOING TO
COMMIT VIOLENCE AGAINST ANOTHER
PERSON TO GO FIND THAT PERSON
AND TELL THEM ABOUT THAT RISK OF
VIOLENCE.
FORESEEABILITY IS HIGH, RISK IS
HIGH, PREVENTABILITY IS HIGH,
THERE'S A STRONG DUTY THERE.
I THINK I'M GOING TO STOP THERE,
BUT I DO JUST WANT TO ENCOURAGE
EVERYONE TO THINK ABOUT THIS
DUTY TO RESCUE.
WHAT A MEANS FOR A RESEARCHER
WHO IS A CLINICIAN VERSUS NOT A
CLINICIAN AND WHAT IT MEANS FOR
STRONG INFORMATION THAT'S
PREVENTABLE AND FOR INFORMATION
THAT WE DON'T HAVE EVIDENCE THAT
IT'S PREVENTABLE.
THANKS SO MUCH.
>>OKAY, THANKS.
QUESTIONS?
>>HI.
IT'S JAYDEN.
HOW WOULD YOU USE YOUR RESULTS
FROM THE FIRST STUDY TO ENHANCE
YOUR SECOND?
LIKE HOW WOULD YOU USE TO
IMPROVE IT, IMPROVE UPON IT OR,
YOU KNOW, HELP PARTICIPANTS IN A
BETTER WAY TO GET THEIR
INFORMATION?
>>SAY THAT AGAIN?
THE PLANNED RETURN OF RESULTS?
>>HOW WOULD YOU USE THE RESULT
THAT YOU PRODUCED IN THE FIRST
ROUND OF RESEARCH TO ENHANCE
YOUR SECOND ROUND?
>>YEAH, THAT'S ACTUALLY A GREAT
QUESTION, BECAUSE I THINK IF WE
ADOPT A RETURN OF RESULTS
APPROACH FOR A RESEARCH STUDY
THAT DOESN'T THEN EVALUATE THAT
THING AS ITS OWN RESEARCH STUDY,
LIKE WE GIVE THIS INFORMATION,
WHAT HAPPENS, THEN WE REALLY
MISS OUT ON AN OPPORTUNITY TO
INFORM THE NEXT TIME WE DO THIS
TYPE OF THING, RIGHT?
AND TO HELP THE WHOLE WORLD OF
RESEARCHERS, EVERYBODY WHO'S
WORKING IN THE SAME FIELD, TO
UNDERSTAND WHAT I DOES THIS
INFORMATION MEAN, WHAT ARE THE
OUTCOMES, WHAT HAPPENS IF WE
TELL A PERSON ABOUT THAT, AND DO
WE BRING ABOUT ANY BENEFIT OR
HARM BY GIVING THAT TO A PERSON,
AND THEN HOPEFULLY THE NEXT TIME
THAT WE DO A STUDY THAT INVOLVES
SIMILAR TYPES OF INFORMATION, WE
WILL KNOW QUITE CLEARLY WHAT WE
SHOULD BE DOING, RIGHT?
SO -- BUT IF WE NEVER STUDY
THAT, WE'LL OVERAND OVER AND OVD
OVER AGAIN DO RESEARCH IN WHICH
WE NEVER KNOW WHETHER THAT
INFORMATION IS HELPFUL OR NOT.
THANK YOU.
>>ANY OTHER QUESTIONS?
MATT?
>>THANKS A LOT, KYLE.
I'D LIKE TO BRING UP ONE OF OUR
CROSS-CUTTING THEMES.
SO THIS WILL BE A QUESTION FOR
YOU BUT FOR THE REST OF THE
WORKSHOP.
AND ONE OF THEM IS HOW DOES
RESULT RETURN TO PREGNANT
PARTICIPANTS AND CHILDREN AND
ADOLESCENTS DIFFER FROM OTHER
ADULTS?
AND I'M THINKING ABOUT YOUR
UNEXPECTED RESULT EXAMPLE.
AND OFTENTIMES WE COLLECT
BIOSAMPLES FROM PREGNANT
PARTICIPANTS AND THEN A YEAR
LATER OR TWO YEARS LATER OR FIVE
YEARS LATER, WE GET A RESULT.
AND MAYBE EVEN NOW WE HAVE SOME
INFORMATION THAT CHANGING THAT
EXPOSURE DURING PREGNANCY COULD
HELP THE PREGNANT WOMAN OR HER
OFFSPRING.
BUT NOW IT'S FIVE YEARS LATER.
AND SO THERE'S A TIME DEPENDENCY
ELEMENT WHEN WE'RE TALKING ABOUT
THESE EARLY LIFE COURSE PERIODS.
WE HAVE CRITICAL PERIODS IN
WHICH SOME EXPOSURE MAY HAVE A
LIFELONG IMPACT, IF IT DURING
THAT CRITICAL PERIOD BUT NOT
LATER.
SO HOW DO YOU THINK ABOUT THAT
KIND OF ISSUE?
AND APPLYING ETHICAL PRINCIPLES?
>>I THINK THIS IS A GREAT
QUESTION FOR THE ECHO
PARTICIPANTS TO GIVE US FEEDBACK
ON, BECAUSE I THINK THERE'S A
DIFFERENCE BETWEEN INFORMATION
THAT I'M RETURNING TO YOU
BECAUSE I THINK RIGHT NOW OR IN
THE NEAR FUTURE, YOU COULD TAKE
ACTION TO PREVENT AN OUTCOME,
AND THERE'S INFORMATION THAT
SOMETHING HAS ALREADY HAPPENED,
AND FOLKS ARE IN A POSITION OF
TRYING TO MAKE SENSE OF EVENTS
THAT HAPPENED TO THEM IN THEIR
LIVES THAT THEY WEREN'T ABLE TO
PREVENT, SO RECEIVING
INFORMATION AFTER THE FACT COULD
ACTUALLY PROVIDE A KIND OF
BENEFIT TO FOLKS SIMPLY BECAUSE
THEY DON'T KNOW WHY A THING
HAPPENED, AND THEY WOULD LOVE TO
HAVE SOME EXPLANATION, LIKE
THEY'RE TRYING TO MAKE MEANING
OF THAT IN THEIR LIVES.
AND MAYBE A GOOD EXAMPLE WOULD
BE FAMILIES WHO HAVE CHILDREN
WITH AUTISM.
FAMILIES WHO HAVE CHILDREN WITH
AUTISM EXPERIENCE GREAT JOY.
THEY ALSO EXPERIENCE QUESTIONS
ABOUT, YOU KNOW, WHY DID THIS
HAPPEN, HOW DID IT COME ABOUT,
COULD I HAVE DONE SOMETHING
DIFFERENTLY, AND OF COURSE WE
KNOW THAT MOTHERS WHO CARRY, YOU
KNOW, THAT HAVE PREGNANCY OFTEN
WONDER, DID I DO SOMETHING
DURING THIS TIME THAT BROUGHT
ABOUT AN OUTCOME?
AND SO I THINK PROVIDING
INFORMATION LATER COULD BE
HELPFUL, BUT IT WOULD BE REALLY
IMPORTANT TO KNOW EMPIRICALLY
WHAT DO FOLKS ACTUALLY THINK WHO
HAVE ALREADY EXPERIENCED THAT
KIND OF OUTCOME, WOULD THEY WANT
THAT KIND OF INFORMATION IN A
PARTICULAR CONTEXT, AND IF WE
DID RETURN TO THEM, DID THEY
FIND, IN FACT, THAT IT HELPED
THEM DEAL WITH THE GUILT OR
MAYBE SORT OF MISPLACED GUILT
ABOUT WHAT HAPPENED OR THE
PROCESS OF MAKING MEANING, DID
IT ACTUALLY BRING ABOUT A
BENEFIT FOR THEM.
I'M SORRY, I'LL ADD ONE LITTLE
ELEMENT HERE.
THE PEDIATRIC CONTEXT, I KNOW
MANY OF YOU WORK IN PEDIATRICS
AND THAT'S SORT OF YOUR BREAD
AND BUTTER, THERE'S ALWAYS THE
QUESTION ABOUT THERE'S A BALANCE
OF INTERESTS FOR CHILDREN.
CHILDREN ARE OFTEN NOT TAKING
ACTION FOR THEIR OWN BENEFIT BUT
THEY DEPEND ON OTHERS TO TAKE
ACTIONS TO HELP THEM.
SO THERE IS A QUESTION ABOUT --
WITH THE TIMING OF INFORMATION,
IS THIS THE KIND OF THING THAT
SINCE IT'S NO LONGER
PREVENTABLE, THE EXPOSURE HAS
ALREADY OCCURRED, IS IT THE KIND
OF THING THAT WE WANT TO TELL
PARENTS SO THEY KNOW THAT ABOUT
THEIR CHILDREN, IS IT THE KIND
OF THING THAT A CHILD WOULD
RATHER LEARN A LITTLE BIT LATER
IN THEIR LIFE, AND HOW DO WE
WEIGH THAT KIND OF A PROCESS OF
A CHILD GROWING FROM A PERSON
WHO'S NOT ABLE TO PROCESS
INFORMATION TO AN ADULT WITH A
SPECTRUM IN BETWEEN, AND HOW DO
WE GO ABOUT DISCLOSING
INFORMATION LIKE THAT TO A
CHILD?
AND ALSO MAKING SURE THAT THE
INFORMATION IS RECEIVED IN A WAY
THAT THE LATER ON THE CHILD
WOULD HAVE APPRECIATED AND
APPROVED AN AS AN ADULT.
>>ANY OTHER QUESTIONS?
GO AHEAD.
>>
[SPEAKING SPANISH]
>>HOW WOULD WE BE MORE
INCLUSIVE OF PARTICIPANTS FROM
DIFFERENT GENERATIONS AND
CULTURE AND LANGUAGE OR SPEAK
OTHER IDIOMS?
>>COULD YOU JUST SAY THAT AGAIN
A LITTLE BIT LOUDER?
SORRY.
>>HOW CAN WE BE MORE INCLUSIVE
OF PARTICIPANTS FROM DIFFERENT
GENERATIONS, CULTURE, AND
LANGUAGE IN THE PROCESS OF
REPORT-BACK?
>>TRULY WONDERFUL QUESTION.
SO THERE'S A BIG ISSUE HERE FOR
DISPARITY AND EQUITY, RIGHT?
THAT'S ACTUALLY MY LAST SLIDE.
I DIDN'T GET A CHANCE TO GET
THERE.
BUT INFORMATION LIKE THIS CAN BE
ESPECIALLY HELPFUL TO PEOPLE WHO
DON'T HAVE ACCESS TO, YOU KNOW,
STANDARD THINGS, RIGHT?
SO IF I DON'T HAVE ACCESS TO
REGULARLY SEEING A PEDIATRICIAN,
FINDING OUT FROM A RESEARCH
STUDY THAT MY CHILD HAS HIGH
BLOOD PRESSURE, THAT COULD BE --
THAT COULD CREATE AN OPPORTUNITY
THAT WASN'T THERE BEFORE, RIGHT?
BUT THAT OPPORTUNITY IS MISSED
IF THE PERSON WHO RECEIVES THE
INFORMATION DOESN'T HAVE THE
ABILITY TO TAKE ACTION TO
ACTUALLY TURN THAT INTO A
BENEFIT.
SO IF I FIND OUT THE AIR QUALITY
INSIDE MY RESIDENCE IS BAD,
THEN -- BUT I DON'T HAVE THE
RESOURCES TO BUY AN AIR FILTER
OR OTHER KIND OF MITIGATING
THING OR MOVE, THEN I'VE NOW
SORT OF EXPERIENCED A VERY
DIFFICULT SITUATION.
BECAUSE I GOT INFORMATION I
COULDN'T ACT ON.
AND I THINK IT'S PROBABLY
IMPORTANT TO SAY BUT MAYBE COULD
GO WITHOUT SAYING THAT, YOU
KNOW, THIS INFORMATION IS NOT
COMMUNICATED IN A LANGUAGE
THAT'S SUCCESSFUL BY THE PERSON
WHO'S RECEIVING IT, THAT'S NOT
THEIR PREFERRED LANGUAGE, AND IF
IT'S NOT RETURNED IN A WAY
THAT'S CULTURALLY -- NOT
CULTURALLY SENSITIVE BUT AT
LEAST, YOU KNOW, WITH THE
UNDERSTANDING OF WHAT THE
CULTURAL IMPACT OF THAT
INFORMATION MIGHT BE, THEN IT'S
NOT GOING TO BE HELPFUL, RIGHT?
IT REALLY -- THAT IS A
PRE-CONDITION FOR ANY BENEFIT
OCCURRING, IS FOR INFORMATION TO
BE RETURNED IN A WAY THAT CAN BE
UNDERSTOOD AND MEETS THE NEEDS
OF THE PERSON RECEIVING IT.
>>I THINK FOR THE PURPOSES OF
TIME WE'LL TRY TO GO AHEAD AND
MOVE ON.
SO THANK YOU, KYLE.
WE'LL GO AHEAD AND HEAR FROM
ADAM BERGER NOW.
>>I JUST WANT TO SAY THANKS TO
CLAY, MATT AND THE ENTIRETY OF
THE ORGANIZERS TO INVITING ME.
IT'S A REAL PLEASURE TO BE HERE
TODAY WITH ALL OF YOU.
THERE ARE A FEW THINGS I WAS
ASKED TO SPEAK ABOUT, AND THIS
IS REALLY THE LEGAL AND
REGULATORY ASPECTS OF RETURN OF
RESEARCH RESULTS AND I DO NEED
TO STATE THAT I'M NEITHER A
LAWYER NOR AM I A REGULATOR
ANYMORE.
SO JUST KEEP THAT IN MIND, I'M
NOT PROVIDING ANY OFFICIAL
ADVICE HERE.
THE OTHER THING I WANTED TO ALSO
MENTION IS I'M NOT GOING TO HAVE
AN OPPORTUNITY TO GO THROUGH IN
GREAT DETAIL, SO YOU'RE GOING TO
GET A PRETTY HIGH LEVEL
OVERVIEW.
I HAVE TRIED TO PUT THINGS
INSIDE THE DECK ITSELF SO YOU'LL
SEE LINKS BELOW IN DIFFERENT
SPOTS.
SO THAT IF YOU WANTED TO GO
BACK, YOU CAN LEARN MORE, READ
ABOUT DIFFERENT PARTS OF THIS.
SO COULD YOU GO TO THE NEXT
SLIDE, PLEASE?
GREAT.
SO THE OVERVIEW OF THE TALK IS
GOING TO FOLLOW ESSENTIALLY
WALKING THROUGH A NUMBER OF LAWS
AND REGULATIONS THAT ARE
RELEVANT HERE, ESPECIALLY AS IT
APPLIES TO RETURN OF INDIVIDUAL
LEVEL RESEARCH RESULTS.
THEN HOW WE'RE ACTUALLY MOVING
MORE TOWARDS A PARTICIPATORY
RESEARCH MODEL.
YOU'VE HEARD A LITTLE BIT ABOUT
THIS IN EACH OF THE PRECEDING
TALKS AS WELL AS SOME OF THE
INTRODUCTIONS THAT PEOPLE HAD
AROUND THE ROOM.
AND THEN OUR ROLE HERE AT NIH
AND WHAT WE'RE TRYING TO DO WITH
RETURN OF RESEARCH RESULTS
THEMSELVES, AND FINALLY, SOME
NEEDS AND OPPORTUNITIES THAT WE
THINK THERE ARE IN THE
COMMUNITY.
AT THE MOMENT.
ALL RIGHT.
SO SOME OF THE SELECT FEDERAL
LAWS AND REGULATIONS, AND I DO
SAY SELECT JUST BECAUSE THERE'S
A LOT OF OTHER LAWS AND
REGULATIONS THAT APPLY MORE
BROADLY, BUT JUST TO GIVE A HIGH
LEVEL CONCEPT OF SOME OF THE
ONES THAT I SEE AS REALLY
IMPORTANT, SO THE CLINICAL
LABORATORY IMPROVEMENT
AMENDMENTS OF 1988, ALSO KNOWN
AS CLIA, AND YOU'LL HEAR ME
REFER TO THAT AS SUCH FROM HERE
ON OUT, SEVERAL SELECT FDA
REGULATIONS, THE HEALTH
INSURANCE PORTABILITY AND
ACCOUNTABILITY ACT ALSO KNOWN AS
HIPAA, AND FINALLY THE COMMON
RULE ITSELF.
SO CAN YOU GO TO THE NEXT SLIDE,
PLEASE.
ALL RIGHT.
SO WE'RE GOING TO START OUT WITH
THE CLIA LAW ITSELF.
THE LAW WAS REALLY AN AMENDMENT
TO THE PUBLIC HEALTH SERVICES
ACT, AND -- WHICH WAS REALLY TO
REVISE TO INCLUDE A FEDERAL
PROGRAM FOR CERTIFICATION AND
OVERSIGHT OF CLINICAL LABORATORY
TESTING.
IN ADDITION TO THE LAW, YOU
ACTUALLY HAVE THE IMPLEMENTING
RELG REGULATIONS AND THOSE REALT
THE STANDARDS FOR ENSURE
RELIABILITY OF LAB TESTS
SPECIFIC TO HUMAN SPENCE MENS
FOR HEALTH ASSESSMENT OR TO
DIAGNOSE, PREVENT OR TREAT
DISEASE.
NOW THE THING THAT I WANT TO
REALLY MAKE CLEAR HERE, THOUGH,
IS THAT CLIA REALLY SETS A
MINIMUM BAR FOR RETURN OF
INFORMATION.
IT'S MEANT TO BE PROTECTIVE OF
PATIENTS SO THEY'RE GETTING
RELIABLE AND ACCURATE
INFORMATION.
CLIA ITSELF AND THE REGULATIONS
ACTUALLY SET OUT A LARGE NUMBER
OF REQUIREMENTS HERE FOR
PERSONNEL TRAINING, ESTABLISHING
OF TEST VALIDITY, SPECIMEN
TRACKING, TEST PERFORMANCE
ASSESSMENT, AND A BUNCH OF OTHER
REQUIREMENTS.
AND LIKE I SAID, IT'S ALL TO
MAKE SURE THAT YOU'RE GETTING
RELIABLE ANALYTICALLY VALID
RESULTS AND THAT THOSE RESULTS
ARE GOING TO THE RIGHT PERSON.
SO THERE'S A BIT OF A TRIFECTA
HERE IN HOW CLIA IS OVERSEEN,
IT'S ACTUALLY OVERSEEN BY CMS,
FDA AND CDC, EACH HAVE VARYING
ROLES AS IT COMES TO CLIA
ITSELF.
SO THESE ARE LARGELY LISTED
HERE.
I'M NOT GOING TO GO THROUGH ALL
THESE TO SAVE TIME BUT YOU CAN
READ THEM AT YOUR LEISURE.
CMS IS THE MAIN PLAYER, ISSUING
CERTIFICATES, MONITORING PR
PRACTICE, REALLY RESPONSIBLE FOR
RULES AND REGULATIONS THAT COME
INTO PLAY.
FDA IS THE ONE THAT SETS THE
COMPLEXITY TESTING, THEY
CATEGORIZE EACH TEST AND THAT
WILL COME INTO MORE CLARITY HERE
AS I CONTINUE.
AND CDC REALLY DOES A LOT OF
TECHNICAL STANDARD DEVELOPMENT,
LABORATORY PRACTICE GUIDELINES,
MONITORING, AS WELL AS
PLANNAGING SOME OF THE ADVISORY
COMMITTEES THAT ACTUALLY
FUNCTION IN THIS SPACE.
SO IMPORTANTLY FOR WHAT WE'RE
TALKING ABOUT, WE'RE REALLY
LOOKING AT RETURN OF RESEARCH
RESULTS, SO HOW DOES CLIA
ACTUALLY INTERSECT WITH
RESEARCH?
SO FIRST OF ALL, CLIA ACTUALLY
APPLIES TO ALL LABS THAT TEST
HUMAN SPECIMENS FOR THE PURPOSE
OF PROVIDING INFORMATION FOR THE
DIAGNOSIS, PREVENTION, OR
TREATMENT OF ANY DISEASE OR
IMPAIRMENT OF OR THE ASSESSMENT
OF THE HEALTH OF HUMAN BEINGS.
NOW THE WAY THE CLIA ACTUALLY
DEFINES A LABORATORY IS
IMPORTANT BECAUSE IT APPLIES --
CLIA IS GOING TO AEMPLOY TO
LABORATORIES.
SO IF YOU ARE ACTUALLY TAKING
PATIENT-SPECIFIC RESULTS AND
THEY'RE REPORTED AND THE RESULTS
ARE BEING MADE FOR THE PURPOSE
OF DIAGNOSIS, PREVENTION OR
TREATMENT AND THE REST OF
EVERYTHING THAT'S QUOTED UP
ABOVE IN THE FIRST BULLET,
YOU'RE A LABORATORY UNDER CLIA.
SO CLIA REQUIREMENTS ARE GOING
TO APPLY.
NOW, THE OTHER THING THAT'S
IMPORTANT TO NOTE HERE IS THE
APPLICABILITY ISN'T ACTUALLY
DEPENDENT ON THE ACTUAL USE OF
THE RESULTS.
SO WHETHER YOU USE THOSE RESULTS
OR YOU DON'T ISN'T REALLY
IMPORTANT.
IT'S REALLY ABOUT THE PURPOSE OF
THE TEST.
SO IF THE RESULTS COULD BE USED
FOR DIAGNOSIS, AND I'M GOING TO
STRESS COULD, IT'S NOT WOULD,
IT'S COULD, BE USED FOR
DIAGNOSIS, PREVENTION, AND THE
REST OF THAT QUOTED TEXT AT THE
FRONT, THEN YOU'RE ACTUALLY
SUBJECT TO CLIA REQUIREMENTS.
AS I MENTIONED, FDA ACTUALLY
SETS THE CATEGORIES FOR ALL OF
THE TESTS THEMSELVES.
RESEARCH TESTS THAT ARE NOT
APPROVED OR CLEARED BY FDA ARE
GOING TO BE CONSIDERED BY
DEFAULT TO BE HIGH COMPLEXITY.
SO REPORT TO REMEMBER THIS.
I'LL COME BACK TO IT LATER ON.
BUT THE PURPOSE HERE IS REALLY
THAT WHEN YOU ACTUALLY HAVE THIS
TYPE OF RESEARCH TEST, IT'S
GOING TO SET THE REQUIREMENTS
THAT ARE GOING TO APPLY.
THE TYPE OF CERTIFICATE YOU'RE
GOING TO HAVE TO APPLY FOR AND
RECEIVE, THE PERSONNEL AND
DOCUMENTARY REQUIREMENTS THAT
ARE GOING TO COME INTO PLAY, AS
WELL AS THE REQUIREMENTS FOR
CONSTANT SURVEILLING OF THE
LABS.
I AND I DON'T MEAN CONSTANT BUT
THE ANNUAL STANDARDS THEY
ACTUALLY GO THROUGH WHEN THEY
COME OUT AND SURVEY.
SO THERE IS A RESEARCH EXCEPTION
BUILT IN TO CLIA THAT ONLY
APPLIES WHEN THE RESEARCH LABS
DO NOT REPORT PATIENT-SPECIFIC
RESULTS.
THE SECOND YOU REPORT
PATIENT-SPECIFIC RESULTS, YOU
HAVE NOW ADDED CLIA REQUIREMENTS
ON TOP OF YOURSELF.
SO IT IS A SELF-DETERMINATION IN
MANY WAYS.
AND I'D BE REMISS IF I DIDN'T
MENTION HERE THAT THERE IS AN
OPEN QUESTION AS TO WHETHER A
RESEARCH LAB CAN AND SHOULD
ACTUALLY HAVE TO MEET THESE
REQUIREMENTS TO BE ABLE TO
RETURN.
I WON'T WADE INTO THAT BUT IT IS
A STRONG DEBATE IN THE FIELD.
NOW, THE OTHER THING TO REMEMBER
ABOUT CLIA IS IT APPLIES TO
HUMAN SPECIMEN TESTING.
SO THAT MEANS THAT IF YOU'RE
GOING TO TEST FOR LIKE AIR
QUALITY OR WATER QUALITY OR
YOU'RE GOING TO LOOK AT
ENVIRONMENTAL -- LIKE VEGETATION
OR SOIL, WE'RE NOT GOING TO BE
TALKING ABOUT CLIA REGULATION
ANYMORE.
BUT THERE IS A FINE LINE HERE
BECAUSE IF YOU'RE TESTING, FOR
INSTANCE, SOIL, YOU'RE LOOKING
AT CHEMICALS IN IT, NOT CLIA.
IF YOU'RE LOOKING AT HUMAN
SPECIMENS AND YOU'RE TESTING FOR
PURPOSES YOU ARE LOOKING AT
CLIA.
SO THERE'S KN NUANCES TO ALL THE
THINGS.
WHAT I WANTED TO POINT OUT, CLIA
ALSO DOESN'T APPLY TO IMAGING.
SO IF YOU'RE TALKING ABOUT
MRIs OR CT SCANS OR OTHER
TYPES OF IMAGING, THAT'S NOT
GOING TO BE CLIA.
BUT, THAT DOESN'T NECESSARILY
MEAN THAT TESTING HUMAN
SPECIMENS INCLUDING UNDER
IMAGING ISN'T SUBJECT TO OTHER
REGULATIONS AND THE SAME THING
WITH NON-HUMAN SPECIMENS.
THERE ARE ALL SORTS OF OTHER
REGULATIONS THAT APPLY ACROSS
THE ENTIRETY OF THE U.S.
GOVERNMENT THAT HAVE BEEN
PROMULGATED SO YOU REALLY HAVE
TO KNOW HOW THOSE REGULATIONS
COME AND HOW THEY APPLY TO YOU.
SOME OF THOSE REGULATIONS
ACTUALLY ARE OVERSEEN BY FDA.
SO FDA ACTUALLY REGULATES BOTH
MANUFACTURERS OF MEDICAL
PRODUCTS, THAT INCLUDES
BIOLOGICS, THAT INCLUDES DRUGS,
INCLUDES DEVICES, AND ALL THIS
IS UNDER THE FEDERAL FOOD, FOOD,
DRUG AND COSMETIC ACT.
THE PURPOSE HERE IS TOE RAO I
ARE ENSURE -- I'M GOING TO FOCUS
ON DEVAS DEVICES ARE REASONABLYE
AND EFFECTIVE.
YOU'RE ACTUALLY ABLE TO DETECT
THE THING YOU CLAIM TO DETECT
AND THAT YOU ARE ACTUALLY --
THAT THE THING YOU DETECT
ACTUALLY IS MEANINGFUL FOR
HEALTH.
OR THE CONDITION OR DISEASE
THAT'S ACTUALLY UNDER
INVESTIGATION.
NOW THAT DOES INCLUDE DEVICES
THAT ARE INTENDED FOR THE USE OF
DIAGNOSIS OF DISEASE AND OTHER
CONDITIONS AND FOR THE
MITIGATION, TREATMENT AND
PREVENTION OF DISEASE.
YOU CAN SEE THE CORRELATIONS
BACK TO HOW CLIA APPLIES.
SO FDA DOES REGULATE ALL OF
THOSE TYPES OF TESTS THEMSELVES.
THE PURPOSE HERE, YOU KNOW, AS I
SAID IS REALLY TO MAKE SURE THAT
WHAT YOU'RE ACTUALLY GETTING IS
ACCURATE INFORMATION.
I'M ONLY GOING TO FOCUS ON TWO
SPECIFIC ASPECTS OF FDA
REGULATION, THERE'S A LOT OF
OTHER PARTS OF THE FDA
REGULATORY SCHEME THAT DOES
APPLY TO TESTING AND DEVELOPMENT
OF RESEARCH.
BUT I'M GOING TO ONLY CHOOSE TWO
OF THESE JUST FOR TIME AND THOSE
ARE LABORATORY DEVELOPED TESTS
ALSO KNOWN AS LDTs, AND THE
INVESTIGATIONAL DEVICE
EXEMPTIONS ALSO KNOWN AS IDEs.
LDTs AS I MENTIONED EARLIER,
YOU KNOW, IF YOU HAVE NOT
ACTUALLY HAD YOUR TEST APPROVED
OR CLEARED BY FDA, YOU'RE LIKELY
GOING TO FALL WITHIN THE SCOPE
OF AN LDT.
THAT MEANS YOU'RE LOOKING AT AN
IN VITRO DIAGNOSTIC TEST WITHIN
A SINGLE LAB, THAT IS SUBJECT TO
REGULATORY OVERSIGHT BY FDA.
SO THINK ABOUT ALL THE MOLECULAR
TESTING WE'VE BEEN TALKING ABOUT
GENETICS AND GENOMICS A LOT SO
THAT'S KIND OF WHERE THIS IS
TAILORED TO, BUT ALL OF THOSE
TYPES OF IN VITRO DIAGNOSTIC
ASSAYS ARE GOING TO BE REGULATED
BY FDA, BUT THEY'RE CONSIDERED
LABORATORY DEVELOPED TESTS.
NOW THAT DOES HAVE IMPLICATIONS
BECAUSE THAT MEANS, AS I SAID
BEFORE, CONSIDERED HIGH
COMPLEXITY, HIGHEST STRINGENCY
OF REQUIREMENTS UNDER CLIA.
BECAUSE THEY'RE EXPERIMENTAL
TESTS, THEY DON'T REALLY
EXIST -- THEY'RE GOING TO LIKELY
FALL TO THE SCOPE OF AN LDT AND
YOU MIGHT HAVE THESE OTHER
CONSEQUENCES STEMMING FROM THAT.
SO IDEs, I'M GOING TO SWITCH
OVER TO A SECONDARY PIECE OF
THIS, APOLOGIES FOR THE BREVITY
AND HOW FAST I'M COVERING THESE,
JUST A LOT TO GET THROUGH.
IDEs DEPENDING ON THE STUDY
MAY BE APPLICABLE.
THIS IS BECAUSE THE WAY FDA HAS
ALWAYS LOOKED AT THIS IS IT'S A
RISK.
AND WE'VE ALREADY HEARD THIS IN
THE PRIOR TWO TALKS, BUT IT
COMES DOWN TO ASSESSING WHAT IS
THE RISK AND IMPACT FOR THE
RESEARCH PARTICIPANT THEMSELVES?
AN IDE BASICALLY ALLOWS FOR AN
INVESTIGATIONAL DEVICE TO BE
USED IN AN STUDY IN ORDER TO
COLLECT SAFETY AND EFFECTIVENESS
DATA.
YOU CAN BE LOOKING AT INTENDED
USE, THE TEST BEING USED, THE
INTENDED POPULATION, WHAT
INFORMATION IS BEING PROVIDED,
AND TO WHOM, AND IN THE CONTEXT,
MATT I'M GOING TO PULL YOUR
QUESTION IN BECAUSE YOU WERE
ASKING DR. BROTHERS AS WELL
ABOUT WHAT HAPPENS PHYSICALLY
FOR, LIKE, PEDIATRIC
POPULATIONS, FOR NEWBORNS,
FETUSES, PREGNANT WOMEN, THOSE
ARE ALL GOING TO BE FACTORED IN.
IF YOU CAN IMAGINE A TEST
SCENARIO WHERE YOU WERE ACTUALLY
DOING -- I'M GOING TO PULL IN
GENETIC TESTING BECAUSE IT'S AN
EASY ONE TO COME THROUGH, IF
YOU'RE DOING GENETIC TESTING AND
GLG TO BE RETURNING INFORMATION
TO AN OAR W OTHERWISE HEALTHY N,
THAT IS A POTENTIAL RISK
IMPLICATION TO BE CONSIDERED.
AS OPPOSED TO WHETHER THERE'S AN
APPARENT DISEASE PRESENT THAT
CHANGES THE RISK PARADIGM.
SO DEPENDING ON WHO YOU'RE
TURNING THAT INFORMATION TO, WHO
IT'S GOING TO BE USED BY AND
WHAT FOR ALL CAN FACTOR INTO
THIS.
SO I'M GOING TO SWITCH GEARS NOW
TO ANOTHER BE LEGAL CONSTRUCT
AND THAT'S HIPAA.
SO I JUST WANT TO POINT OUT,
HIPAA IS ACTUALLY OVERSEEN BY
THE OFFICE OF CIVIL RIGHTS AT
HHS.
THEY'RE RESPONSIBLE FOR ITS
IMPLEMENTATION AND ENFORCEMENT
HERE.
AND THE STANDARD HERE IS THAT
HIPAA REQUIRES COVERED ENTITIES
AND THEIR BUSINESS ASSOCIATES TO
GIVE INDIVIDUALS ACCESS TO A
COPY OF THEIR PROTECTED HEALTH
INFORMATION THAT'S HELD IN A
DESIGNATED RECORD SET.
THIS COLLOQUIALLY CALLED THE
RIGHT OF ACCESS.
YOU MIGHT BE ASKING YOURSELF
WHAT IS A COVERED ENTITY?
HEALTH PLANS, HEALTHCARE
CLEARINGHOUSES, HEALTHCARE
PROVIDERS WHO ELECTRONICALLY
TRANSMIT ANY HEALTH INFORMATION
IN CONNECTION WITH TRANSACTIONS
FOR WHICH HHS HAS ADOPTED
STANDARDS.
SO IMAGINE IF YOU ARE BILLING
FOR SERVICES, YOU'RE GOING TO BE
A COVERED EN ENTITY.
HOPEFULLY THAT GIVES A LITTLE
BIT OF A CONTEXT.
SO THE OTHER ADVICE YOU MIGHT BE
ASKING YOURSELF, WHAT IS A
DESIGNATED RECORD SET?
IF HIPAA APPLIES TO DESIGNATED
RECORD SETS AND THAT'S WHAT YOU
HAVE ACCESS TO, WHAT IS A
DESIGNATED RECORD SET?
THE DRS IS A GROUP OF RECORDS
MAINTAINED BY OR FOR A COVERED
ENTITY THAT COMPRISES THE
MEDICAL AND -- RECO BILL RECORDN
INDIVIDUAL, ENROLLMENT, PAYMENT,
CLAIMS ADJUDICATION, CASE OR
MEDICAL MANAGEMENT, RECORD
SYSTEMS MAINTAINED BY OR FOR A
HEALTH PLAN USED IN WHOLE OR IN
PART BY COVERED ENTITY TO MAKE
DECISIONS ABOUT INDIVIDUALS.
THE IMPORTANT THING TO THINK
ABOUT HERE IS THAT RESEARCH
RECORDS THAT ARE MAINTAINED AS
PART OF THE DESIGNATED RECORD
SET ARE INCLUDED UNLESS THEY'VE
BEEN ACCEPTED.
SO THERE ARE SPECIFIC EXCEPTIONS
HERE, BUT IF YOU HAVE YOUR
RESEARCH RECORD IN AS PART OF
THE DESIGNATED RECORD SET, THAT
MEANS YOU HAVEN'T SEGREGATED IT
AS PART OF YOUR EHR, THAT'S PART
OF THE DESIGNATED RECORD SET.
IF YOU SEGREGATED IT AWAY, IT'S
NOT PART OF THE RECORD SET AND
THERE ARE OTHER THINGS THAT ARE
GOING TO APPLY.
SO LET'S GO TO THE NEXT SLIDE,
BECAUSE WE'LL GET INTO THIS.
SO HIPAA, HOW IT APPLIES TO
RESEARCH.
SO THE COVERED ENTITY COULD BE
BOTH A CLINICAL AND -- HAVE BOTH
CLINICAL AND RESEARCH
COMPONENTS.
AND IT'S IMPORTANT TO NOTE THAT
IT'S THE INSTITUTION THEMSELVES
THAT ACTUALLY DETERMINE WHICH
COMPONENTS ARE COVERED UNDER
HIPAA AND WHICH ONES ARE NOT.
A AND SO YOU CAN EITHER CHOOSE E
WHOLLY COVERED UNDER HIPAA OR
YOU CAN BE A HYBRID ENTITY.
SO YOU CAN CHOOSE TO DESIGNATE
WHICH PARTS ARE HEALTHCARE
COMPONENTS, WHICH PARTS ARE NOT
HEALTHCARE COMPONENTS.
SO IF YOUR INSTITUTION
DESIGNATES A RESEARCH LAB AS
PART OF ITS HEALTHCARE
COMPONENT, IT IS GOING TO BE
CONSIDERED PART OF THE COVERED
ENTITY AND IT'S GOING TO BE
SUBJECT TO HIPAA REQUIREMENTS.
IF THE RESEARCH COMPONENTS ARE
NOT -- ARE SPECIFICALLY EXCLUDED
THEN THEY'RE NOT GOING TO BE
SUBJECT TO THE PRIVACY RULE.
NOW, THAT MEANS THAT DATA
COLLECTED FROM RESEARCH LABS
THAT ARE EXCLUDED ARE NOT GOING
TO HAVE TO -- ARE NOT SUBJECT TO
THE PRIVACY RULE, THEY'RE NOT
SUBJECT TO THE DESIGNATED RECORD
SET BECAUSE THEY'RE NOT PART OF
IT THEREFORE THERE IS NO RIGHT
TO ACCESS THAT INFORMATION.
SO YOU'VE GOT A DIFFERENCE -- A
LOT OF THIS WILL DEPEND GREATLY
ON THE INSTITUTIONAL DECISION
THAT'S MADE.
I'D BE REMISS IF I DIDN'T
MENTION THE FACT THERE'S BEEN
NUMEROUS PAPERS WRITTEN
CONCLUDED THAT THERE IS A
CONFLICT BETWEEN HIPAA AND CLIA
WHEN YOU'VE GOT PARTICIPANTS
DESIRING ACCESS TO TEST RESULTS
FOR NON-CLIA CERTIFIED RESEARCH
LABS THAT EXIST WITHIN A
HIPAA-COVERED ENTITY.
I'M NOT GOING TO WADE INTO THAT
DEBATE HERE, I JUST WANT TO MAKE
SURE THAT PEOPLE ARE AWARE THAT
THAT IS A DEBATE THAT HAS BEEN
MADE OR THAT IS AN ARGUMENT THAT
HAS BEEN MADE.
I WILL JUST GO BACK AND SAY A
LOT OF THAT IS GOING TO BE
DETERMINED BY THAT INSTITUTIONAL
DECISION.
SO I'M GOING TO TRY AND COVER
THESE THINGS REALLY QUICKLY.
COMMON RULE IS THE LAST
REGULATION I'LL MENTION.
THIS IS THE FEDERAL HHS
REGULATION FOR THE PROTECTION OF
HUMAN SUBJECTS.
IN RESEARCH.
WHY IS IT RELEVANT HERE?
IT'S BECAUSE COMMON RULE APPLIES
TO HEUL MAN SUBJECTS RESEARCH
ITSELF.
AND THE REQUIREMENTS ARE
APPLICABLE BASED ON THAT.
ONE THING I'LL POINT OUT, I'M
GOING TO SKIP THE FIRST TWO
BULLETS, ONE OF THE REQUIREMENTS
IN THE COMMON RULE AND WE HEARD
EARLIER FROM JEFF THAT INFORMED
CONSENTS WILL OFTEN LIST THIS,
WHETHER YOU'RE GOING TO HAVE
INFORMATION RETURNED OR NOT,
THIS IS A REQUIREMENT TO THE
COMMON RULE IF YOU WERE
CONDUCTING HUMAN SUBJECTS
RESEARCH SO YOU HAVE TO ACTUALLY
INDICATE -- YOU HAVE TO INCLUDE
A STATEMENT REGARDING WHETHER
CLINICALLY RELEVANT RESEARCH
RESULTS WILL BE RETURNED OR WILL
BE DISCLOSED TO RESEARCH
PARTICIPANTS.
BUT IT WAS ALSO PREVIOUSLY NOTED
JUST BECAUSE IT'S EEDZIER, YOU
KNOW, OFTEN, DOESN'T MEAN IT'S
THE RIGHT THING TO DO.
AND THERE REALLY IS A NEED FOR
BALANCE.
I THINK YOU HEARD A LOT OF THIS
COMING IN FROM THE INTROS WE D
WE REALLY ARE MOVING TOWARDS A
MORE PARTICIPATORY MODEL OF
RESEARCH ITSELF.
PARTICIPANTS EXPECT AND WANT TO
HAVE THE OPTION TO HAVE THEIR
PERSONAL RESULTS RETURNED.
RECEIVING RESULTS HAVE MANY
BENEFITS TO BOTH PARTIES HERE.
IT CAN BE A REAL INCENTIVE TO
PARTICIPATING IN RESEARCH
ITSELF.
SO WE VIEW RETURN OF RESULTS,
AND NIH HAS LONG SUPPORTED THIS
MOVEMENT, SPECIFICALLY IN THE
CONTEXT OF TREATING PARTICIPANTS
AS EQUAL PARTNERS IN THE
RESEARCH.
THAT MEANS EQUALITY IN INFORMING
RESEARCH PRIORITIES AND ADVISING
STUDY DESIGN.
IMPORTANTLY WE REALLY VIEW THE
RETURN OF RESEARCH RESULTS AS
BEING RESPECTFUL OF THE AUTONOMY
OF THE INDIVIDUALS AND ALSO
HELPING TO CONTRIBUTE TO THE
ADVANCEMENT OF SCIENCE.
IT'S VERY RESPECTFUL IN OUR
VIEW.
AND I KNOW I'M OVER TIME, I
APOLOGIZE.
I'M GOING TO SKIP REALLY QUICKLY
HERE TO THE END.
I'LL JUST SAY THERE'S ALREADY
RETURN OF RESULTS THAT ARE BEING
SUPPORTED HERE AT THE NIH IN
TERMS OF RESEARCH, IN TERMS OF
STUDIES THAT ARE DOING THIS.
I'VE LISTED A COUPLE HERE, I
WON'T GO THROUGH THIS BUT WILL
POINT OUT GENERALLY WHAT WE ARE
LOOKING AT TRYING TO ENCOURAGE
GREATER RETURN IN ACCORDANCE
WITH CURRENT REQUIREMENTS.
THERE IS A FUNDING OPPORTUNITY
THAT'S GOING TO BE GOING OUT
SOON THAT IS GOING TO BE
SPECIFICALLY LOOKING AT THE
RETURN IN ENVIRONMENTAL HEALTH
AND NON-GENOMIC RESEARCH
RESULTS.
LAST SLIDE QUICKLY.
SO THERE ARE A LOT OF RESEARCH
NEEDS AND OPPORTUNITIES.
I WILL ADD ONE THAT'S NOT ON
THIS LIST.
AND IT'S REALLY TO HELP DRIVE
GREATER UNDERSTANDING OF THE
REGULATORY IMPLICATIONS OF
RETURN.
SO WHEN A DECISION IS MADE TO
RETURN, THOSE REALLY DO -- THOSE
REALLY DO IMPART A DIFFERENT
REGULATORY SCHEMA THAT YOU NEED
TO BE COGNIZANT OF, SO REALLY
THINKING ABOUT OPPORTUNITIES TO
HELP ENSURE THAT THERE'S GREATER
UNDERSTANDING OF THIS.
AND ALL OF THESE ARE REALLY
IMPORTANT NEEDS.
YOU NEED TO KNOW WHAT TO RETURN,
WHEN TO RETURN, HOW TO RETURN
IT, HOW PEOPLE ARE GOING TO USE
IT DOWNSTREAM.
THERE ARE A WHOLE BUNCH OF
RESOURCES THAT ARE GOING TO
BENES NECESSARY TO THIS,
INFRASTRUCTURE SUPPORTS THAT ARE
NECESSARY, AND
ENVIRONMENTALLY-WISE, I THINK
ABOUT THIS FROM A GENETIC
STANDPOINT, WE HAVE GENETIC
TRANS LAY INVENTORIES WHO CAN
HELP TRANSLATE THAT INFORMATION
SO PEOPLE CAN UNDERSTAND WHAT IT
MEANS.
THERE REALLY ISN'T AN EQUIVALENT
HERE FOR ENVIRONMENTAL HEALTH.
BUT IT IS AN OPPORTUNITY FOR A
NEW FIELD TO BE THOUGHTFUL.
SO WITH THAT, I WILL CONCLUDE
AND JUST SAY THANK YOU THAO ALL.
IF YOU HAVE ANY QUESTIONS, HAPPY
TO ANSWER.
SORRY FOR THE SPEED.
I KNOW THAT WAS JUST A LOT TO
COVER.
>>CLAY.
>>THE INFAMOUS MICROPHONE.
YOU MENTIONED AB NIH EFFORT TO
INCLUDE RESEARCH PARTICIPANTS
AND STUDY DESIGN.
I'M WONDERING IF -- FIRST OF
ALL, ARE YOU SATISFIED WITH HOW
MUCH THAT'S HAPPENING?
ARE YOU AWARE OF SOME CONCRETE
EXAMPLES?
BUT THEN ALSO DO YOU TALK
ABOUT -- YOU KNOW, IF YOU'RE
AWARE OF SOME EXAMPLES, DO THEY
TALK ABOUT PREFERENCES FOR
RETURN OF RESULTS IN THOSE?
>>SO I'LL SAY THIS IS A NEWER
SPACE FOR NIH AND ONE WE'VE
REALLY BEEN PUSHING FORWARD A
LOT ON.
THERE ARE GOOD EXAMPLES COMING
OUT WHERE WE REALLY ARE TRYING
TO DO ENGAGEMENT, WE'VE HAD A
LOT OF COMMUNITY ENGAGEMENT
ACTIVITIES THAT HAVE GONE ON,
ESPECIALLY IN THE LAST FEW
YEARS.
BUT A LOT OF THIS HAS REALLY
TRIED TO MAKE SURE THAT WE ARE
LISTENING AND HEARING FROM
PARTICIPANTS, THAT THEY ARE
ACTUALLY AT THE TABLE AND
SPEAKING AS ONE OF THE OUTCOMES
THAT THEY WANT TO SEE AS PART OF
THE RESEARCH.
WE THINK ABOUT -- ESPECIALLY FOR
ME I THINK ABOUT THE CLINICAL
RESEARCH REALM, I'M THINKING
OFTEN ABOUT PRIMARY OUTCOME
MEASURES AND WHAT I'M TRYING TO
ACTUALLY ACHIEVE WITH WHATEVER
RESEARCH STUDY IS GOING ON.
WHAT ARE THE IMPORTANT OUTCOMES
THAT RESEARCH PARTICIPANTS WANT
TO KNOW ABOUT, AND CAN WE ALIGN
THOSE?
THAT'S REALLY WHERE WE'RE TRYING
TO GET TO.
WE WANT TO MAKE SURE THAT WE'RE
ACTUALLY CREATING MEANINGFUL
SCIENTIFIC RESEARCH RESULTS FOR
THE PUBLIC.
YOU KNOW, I WON'T SAY THAT WE'RE
SATISFIED BECAUSE THERE'S A LOT
OF WORK TO BE DONE.
I MEAN, I THINK WE ARE MAKING
GOOD PROGRESS AND WE'RE CONSTANT
I TRYING TO MOVE FORWARD.
BUT THERE'S ALWAYS GOING TO BE
MORE THAN WE CAN DO.
AND I THINK THAT'S THE ONLY
REASON I'M SAYING, OF COURSE
WE'RE NOT SATISFIED, WE WANT TO
MAKE SURE THIS IS REALLY
WIDESPREAD.
I'M NOT SURE WHO'S CALLING OUT
QUESTIONS, SO --
>>JEFF, GO AHEAD.
>>ONE OF THE THINGS THE
NATIONAL ACADEMY STATEMENT
FOCUSED ON WAS LABORATORY
QUALITY ISSUES FOR NON-CLIA
CERTIFIED LABS, AND I THINK THE
NOTION WAS, YOU KNOW, I KNOW
MANY OF THESE LABS ARE SUPPORTED
THROUGH NIH RESEARCH ARE VERY
HIGH QUALITY AND WOULD MEET CLIA
STANDARDS, BUT WE ALSO KNOW
OTHER ONES AREN'T.
SO THERE WAS A NOTION OF SAYING
NIH OUGHT TO TRY TO ENCOURAGE
THE DEVELOPMENT OF LABORATORY
STANDARDS, QUALITY STANDARDS FOR
LABS THAT ARE NOT CLIA
CERTIFIED.
SO I'M WONDERING WHETHER THERE'S
BEEN ANY FURTHER DISCUSSION OR
PROGRESS ON THAT PARTICULAR
QUESTION.
>>THANKS, JOAF.
JEFF.I THINK YOU'RE REFERRING TE
QUALITY MANAGEMENT SYSTEM THAT
WAS RECOMMENDED AS PART OF THE
REPORT ITSELF.
IT'S AN INTERESTING QUESTION,
AND I HAVE TO SAY AS A FORMER
PERSON WHO USED TO BE AT THE
BENCH, I KNOW THAT THE STANDARDS
CAN VARY BETWEEN LABS.
THE QUESTION I THINK COMES DOWN
TO WHO'S THE RIGHT -- WHERE'S
THE RIGHT PLACE TO BE ABLE TO DO
THIS.
I'LL JUST REMIND YOU, NIH ISN'T
A REGULATORY AGENCY, AND SO
OTHER AGENCIES EXIST LIKE CMS TO
ACTUALLY REGULATE THAT TYPE OF
TESTING AND ENVIRONMENT.
SO I THINK THERE'S STILL A
QUESTION AS TO WHERE THAT
QUALITY SYSTEM SHOULD BE COMING
FROM AND WHERE IT CAN COME IN.
YOU KNOW, I DON'T HAVE AN ANSWER
FOR YOU ON THAT ONE TODAY, BUT I
THINK IT'S A RECOGNIZED ISSUE IS
HOW DO WE ASSURE QUALITY.
AT THE END OF THE DAY, WE WANT
TO MAKE SURE THAT IF WE ARE
ROMAN CATHRETURNING INFORMATIONS
BEING RETURNED TO THE RIGHT
PERSON, AND IT'S AT LEAST
ACCURATE.
>>HI.
SO WITH THE NAVAJO RESERVATION,
I KNOW WE'RE NOT CLIA CERTIFIED,
BEING UNDER THE IHS GOVERNMENT.
DOES THAT PUT US IN A POSITION
WHERE OUR PARTICIPANTS WON'T BE
ABLE TO GET THOSE RESULTS UNLESS
OTHERWISE HIPAA RELEASES THOSE
RESULTS?
AND THEN THAT PERTAINS TO, AS A
PARTICIPANT MYSELF, WITH THE
MULTIPLE DIAGNOSES FOR MYSELF AS
A PRENATAL PATIENT AND ALSO FOR
MY DAUGHTER BEING BORN WITH
MULTIPLE DISABILITIES, OR
DELAYS, THAT PUTS US IN A
POSITION TO NOT BE ABLE TO -- OR
HOW WOULD WE GO AROUND FINDING
OUT IF THAT EXPOSURE COULD
PERTAIN TO THE NEW DIAGNOSES
THAT WE DO HAVE?
AND THAT KIND OF PUTS US IN A
CLOUD AS PARTICIPANTS.
SO THAT WAS MY QUESTION, LIKE
HOW DO WE GO AROUND THAT, BEING
A NON-CLIA CERTIFIED UNDER IHS
GOVERNMENT?
>>SO YOU'RE PUTTING IN OTHER
COMPLICATIONS, YOU'RE TALKING
ABOUT OTHER AGENCIES THAT
OVERSEE DIFFERENT ASPECTS, BUT I
WILL REFER BACK TO SOME OF THE
OTHER PIECES.
INSTITUTIONS MAKE DECISIONS
ABOUT WHETHER A RESEARCH
COMPONENT IS PART OF THE COVERED
ENTITY OR NOT.
AND SO DEPENDING ON HOW THAT'S
ACTUALLY BEEN DECIDED WILL
DEPEND ON CLIA CERTIFICATION IS
REQUIRED TO RETURN.
NOW, IF IT'S A NON-CLIA
CERTIFIED LAB AND THEY'RE
RETURNING INFORMATION, THE ONLY
THING I CAN SAY IS TECHNICALLY
THE REQUIREMENTS MAY -- THEY MAY
APPLY IN THOSE CASES SO YOU HAVE
TO LOOK SPECIFICALLY AT THE
CONTEXT OF THE INFORMATION BEING
RETURNED, HOW IT'S BEING
RETURNED, TO WHOM AND WHAT THE
URPS PURPOSE OF THE TESTING IS.
UNFORTUNATELY IT'S NOT THE
ANSWER I LIKE TO GIVE BUT THE
BEST ANSWER I CAN GIVE IS IT'S
BEST TO SPEAK TO THE STUDY STAFF
ITSELF, AND TALK TO THEM ABOUT
WHAT PROCESSES THEY'VE PUT IN
PLACE TO ENABLE RETURN OF
INFORMATION, BECAUSE YOU'RE
GOING TO BE IN A SPECIFIC STUDY
ITSELF AND THEY'VE MADE
DIFFERENT ARRANGEMENTS FOR DOING
THAT.
THE CONTEXT REALLY MATTERS.
SO THE BEST I CAN DO IS TELL
YOU, GO MAKE SURE THAT THOSE
CONCERNS ARE RELATED TO YOUR
STUDY TEAM, AND MAKE SURE THAT
THEY HEAR THOSE.
>>HI.
DO YOU GUYS ENSURE THE PROPER
SECURITY OF OUR SPECIMENS AND
HOW THEY'RE TREATED AND DISPOSED
OF, AND ARE YOU GUYS REQUIRED TO
LET US KNOW WHEN THEY ARE BEING
DISPOSED AND HOW THEY'RE BEING
DISPOSED?
>>SO IT'S A GREAT QUESTION, AND
THE QUESTION HERE IS WHAT
HAPPENS WITH THE SPECIMENS
THEMSELVES.
ALL THAT SHOULD BE SPELLED OUT
IN THE INFORMED CONSENT.
THEY SHOULD MAKE YOU AWARE OF
THAT WHEN YOU'RE COMING INTO THE
STUDY, WHAT THE DISPOSITION OF
THOSE SAMPLES ARE GOING TO BE,
HOW THEY'RE GOING TO STORE THEM
AND PROTECT THEM.
HERE AT NIH, WE PUT A PREMIUM ON
ENSURING CONFIDENTIALITY AND
PRIVACY OF OUR RESEARCH
PARTICIPANTS, AND THAT INCLUDES
ANY SPECIMENS THAT MIGHT BE
COLLECTED IN THE PROCESS OF THE
RESEARCH, SO ALL THOSE THINGS
SHOULD BE SPELLED OUT.
THERE SHOULD BE PROTECTIONS PUT
IN PLACE, FOR INSTANCE, TO
ENSURE YOUR CONFIDENTIALITY.
THERE ARE OTHER REGULATIONS THAT
APPLY TO DISPOSITION OF HUMAN
SPECIMENS, AND I WON'T GET INTO
LIKE HOW MEDICAL WASTE IS
DISPOSED OF SPECIFICALLY, BUT
THERE ARE OTHER PROCESSES THAT
COME INTO PLAY THAT REGULATE
THAT.
THERE ARE ALSO DIFFERENT
CONSIDERATIONS, I KNOW THERE ARE
CULTURAL SENSITIVITIES FOR
DISPOSITION OF SAMPLES,
ESPECIALLY AMERICAN INDIAN AND
ALASKA NATIVE POPULATIONS IN
PARTICULAR SOG THERE ARE OTHER
CULTURAL CONSIDERATIONS THAT GO
INTO HOW SPECIMENS ARE
COLLECTED, STORED, USED AGAIN
FOR FUTURE OR DISPOSED.
>>OKAY.
I THINK IN THE INTEREST OF TIME,
WE'LL MOVE ON, SO THANK YOU,
ADAM.
AND WE'RE NOW GOING TO HEAR FROM
OUR DISCUSSANT, INGRID HOLM.
>>ALL RIGHT.
THANK YOU.
SO FIRST OF ALL, JUST TO SAY
THAT WAS A GREAT SESSION THIS
MORNING.
WE HAD SOME REALLY GREAT TALKS.
I THINK WHAT I'M GOING TO TRY TO
DO IS --
>>INGRID?
>>CAN YOU NOT HEAR ME?
>>WOULD YOU LIKE TO COME UP TO
THE FRONT TABLE OR TO THE
PODIUM?
>>CAN I BRING MY COMPUTER?
I HAVE MY NOTE.
OKAY.
I THINK MY JOB AS A DISCUSSANT
IS TO SUMMARIZE WHAT'S KIND OF
BEEN DISCUSSED IN THESE
PRESENTATIONS THIS MORNING, AND
I WILL PROBABLY ADD IN A COUPLE
OF MY OWN KIND OF THOUGHTS ABOUT
IT.
SO I THINK -- SO FIRST OF ALL, I
THINK ONE OF THE FIRST POINTS
THAT JEFF MADE IS THIS IDEA OF
AGGREGATE RESULTS.
SO THAT'S KIND OF SOMETHING TO
REALLY THINK ABOUT IN DOING
STUDIES, IS KIND OF BRINGING IN
AND RETURNING RESULTS OF THE
STUDY TO PARTICIPANTS, AND
THAT'S CERTAINLY VERY IMPORTANT.
AND WHEN WE THINK ABOUT
INDIVIDUAL RESULTS THAT'S BEEN
DISCUSSED WHI QUITE A BIT, I THK
PEOPLE AT THIS TIME REALLY
EXPECT TO GET INDIVIDUAL RESULTS
BACK, AND I THINK AS IT WAS
MENTIONED 15, 20 YEARS AGO, THIS
WAS NOT WHERE WE ARE AND THERE'S
BEEN THIS WHOLE PROCESS,
PARTICULARLY IN THE AREA OF
GENOMICS, WHICH IS WHERE WE'VE
REALLY LEARNED A LOT ABOUT
RETURN OF RESULTS AND THE VALUE
OF RETURNING RESULTS TO
INDIVIDUAL PARTICIPANTS.
AND WE'VE ALSO TALKED A LOT
ABOUT PRE RECIPROCITY, TRANSPARY
AND COMMUNICATION.
I THINK THOSE ARE THREE OF THE
KIND OF FOUNDING PILLARS WHEN WE
THINK ABOUT RETURNING RESULTS
AND THE IMPORTANCE OF DOING
THAT.
WE'VE ALSO TALKED A LITTLE BIT
ABOUT DIFFERENT KINDS OF RESULTS
TO RETURN.
SO WE THINK ABOUT -- AGAIN,
WE'RE KIND OF DRAWING ON WHAT
WE'VE LEARNED IN THE AREA OF
GENETICS, WE THINK ABOUT
CLINICAL UTILITY, THINGS THAT
PEOPLE CAN DO, SOMETHING
ABOUT -- THAT I THINK IN
PARTICULAR ENVIRONMENTAL
STUDIES, THERE MAY BE A LOT OF
COMPONENTS OF KIND OF PERSONAL
UTILITY.
AND SO THE BENEFITS OF GETTING
RESULTS BACK AND EVEN THOUGH YOU
MAYBE CAN'T CHANGE SOMETHING,
THEY BRING SOME PERSONAL UTILITY
TO UNDERSTANDING -- KIND OF
UNDERSTANDING.
I THINK AN IMPORTANT ASPECT THAT
WAS BROUGHT UP WAS THIS IDEA
THAT KYLE DISCUSSED ABOUT
EXPECTED VERSUS UNEXPECTED
RESULTS.
AND WHEN WE THINK -- SO IN
GENETICS, WHEN YOU'RE LOOKING AT
AN ENTIRE -- THE WHOLE KIND OF
GENOME AND ALL THAT DATA, THERE
ARE GOING TO BE THINGS IN THERE
THAT YOU WEREN'T LOOKING FOR
THAT YOU ARE POTENTIALLY GOING
TO FIND, AND I THINK THAT MAY BE
THE SIMILAR KIND OF SITUATION IN
THE ENVIRONMENTAL REALM.
SO KYLE AND I HAD DINNER LAST
NIGHT AND WE WERE KIND OF
THINKING ABOUT WHAT KIND OF
UNEXPECTED RESULTS COULD ONE
HAVE, FOR EXAMPLE, IN
ENVIRONMENTAL EXPOSURES, AND YOU
MIGHT FIND AN EXPOSURE IS
SOMETHING THAT YOU WEREN'T
EXPECTING THAT SUGGESTS A
PROBLEM YOU HADN'T REALLY
THOUGHT ABOUT.
SO ONE OF THE THINGS THAT WE
KIND OF THOUGHT ABOUT IS IF, FOR
EXAMPLE, SUBSTANCE ABUSE, OR A
CHILD THAT HAD SOME KIND OF --
SOMETHING IN THEIR EXPOSURE THAT
REALLY WAS SOMETHING THAT WAS
COMING FROM, FOR EXAMPLE, A
PARENT AND COULD SUGGEST CHILD
ABUSE.
THERE'S THESE KINDS OF THINGS
THAT I THINK IT'S IMPORTANT TO
THINK ABOUT IN THE ENVIRONMENTAL
SENSE THAT THERE ALSO MAY BE
THESE KIND OF UNANTICIPATED
FINDINGS THAT MAY BE IMPORTANT
FOR INDIVIDUALS TO KNOW ABOUT
AND POTENTIALLY HOW YOU WOULD
LAN DELL THOSE.
HANDLE THOSE.
AGAIN WE'RE JUST MAKING UP IDEAS
BUT WHEN WE'RE THINKING ABOUT
THE ENVIRONMENTAL -- AREA OF
ENVIRONMENTAL EXPOSURES.
SO THERE'S A LOT OF DISCUSSION
ABOUT BENEFITS AND HARMS, AND I
THINK CERTAINLY -- WE TALKED A
LOT ABOUT THAT BUT ONE OF THE
THINGS THAT KIND OF CAME UP TO
ME AS PART OF THE DISCUSSION WAS
THIS IDEA THAT POTENTIALLY YOU
CAN GET INFORMATION BACK THAT
YOU CAN'T ACT ON.
AND SO WE KEPT THINKING ABOUT
HARMS AND BENEFITS AND THE HARMS
POTENTIALLY OF GIVING PEOPLE
INFORMATION THAT'S IMPORTANT BUT
THEY DON'T HAVE THE RESOURCES,
FOR EXAMPLE, TO ACT ON IT.
SO IT'S JUST TO MAKE THE POINT
THAT BENEFITS AND HARMS IS QUITE
A BROAD AREA, AND IT'S IMPORTANT
TO REALLY THINK ABOUT WHAT
POTENTIAL HARMS THERE COULD BE
IN COMMUNITIES.
WHICH GETS BACK TO ALSO THE
DISCUSSION WE'VE HAD KIND OF OFF
AND ON HERE ABOUT COMMUNITY
ENGAGEMENT.
AND SO REALLY WORKING WITH
COMMUNITIES AND UNDERSTANDING,
BECAUSE WE MAY NOT APPRECIATE
WHAT SOME OF THE BENEFITS AND
HARMS MIGHT BE TO COMMUNITY
WITHOUT TALKING TO THEM ABOUT IT
AND FINDING OUT WHAT THOSE --
KIND OF WHAT THOSE BE BENEFITS
MIGHT BE.
SO I WANTED TO JUST ADDRESS
MATT'S QUESTION ABOUT
PARTICULARLY IN THE AREAS OF
KIND OF PREGNANCY AND CHILDREN,
AND KYLE TALKED A LITTLE BIT
ABOUT THIS ALSO, WHAT ARE THE
THINGS TO THINK ABOUT.
AND I THINK THE TWO KIND OF
AREAS -- TWO AREAS.
ONE IS THIS IDEA OF GIVING
INFORMATION ABOUT A CHILD
WITHOUT -- BEFORE THEY HAVE THE
CHANCE TO DECIDE IF THEY WANT
THAT INFORMATION OR NOT.
SO IN GENETICS, WE TALK A LOT
ABOUT THAT, RETURNING
INFORMATION ABOUT CONDITIONS
THAT ARE ONLY ACTIONABLE IN
ADULTHOOD AND MAYBE WE SHOULD
WAIT UNTIL THE CHILD BECOMES AN
ADULT TO MAKE THOSE DECISIONS,
AND SO I THINK IN THE KIND OF
ENVIRONMENTAL EXPOSURES AND THE
THINGS THAT YOU ARE STUDYING IN
ECHO, JUST THINKING ABOUT ARE
THERE KIND OF RESULTS THAT COULD
BE POSSIBLE THAT YOU WOULD WANT
TO GIVE A CHILD AN OPPORTUNITY
TO REACH THE AGE OF MAJORITY
WHEN THEY CAN MAKE DECISIONS
ABOUT WHETHER THEY WANT TO KNOW
ABOUT, AND AGAIN, IT'S GOING TO
BE VERY DEPENDENT ON WHAT KIND
OF THINGS YOU'RE FINDING OR
LOOKING AT BUT SOMETHING TO
CONSIDER IN THE RETURN OF
RESULTS IN CHILDREN, WHAT'S KIND
OF ACTIONABLE FOR THE CHILD IN
THEIR LIFE.
THE OTHER WAS THE KIND OF
QUESTION ABOUT PREGNANCIES AND
THE BENEFITS, WHAT MATT ASKED OF
GETTING AFTER THE FACT
INFORMATION.
AS YOU WERE TALKING ABOUT THAT,
I WAS THINKING, I'M A CLINICAL
GENETICIST SO I RETURN
INFORMATION TO FAMILIES ALL THE
TIME ABOUT THEIR CHILD THAT'S
NOT ACTIONABLE, THE CHILD HAS A
CONDITION, WE CAN'T CHANGE IT,
IT IS WHAT IT IS, BUT IT DOES
INFORM THE KIND OF FUTURE
PREGNANCIES SO THERE'S ALSO THAT
KIND OF ASPECT TO THINK ABOUT,
IS THAT A PREGNANT PERSON,
THEY'VE BEEN PREGNANT, THEY'VE
HAD THEIR CHILD, YOU FIND
SOMETHING LATER, BUT IT MAY
INFORM THEM HOW THEY VIEW KIND
OF FUTURE PREGNANCIES.
ONE OF THE OTHER THINGS I WANTED
TO KIND OF HIGHLIGHT IS THIS
ISSUE OF -- THAT JEFF TALKED
ABOUT WHICH IS FEASIBILITY AND
VALUE.
SO THERE'S A LOT OF TALK IN KIND
OF RESEARCH ABOUT IS THERE AN
OBLIGATION TO RETURN RESEARCH
RESULTS WE DO MOST OF THE TIME,
BUT THERE MAY BE TIMES WHEN IT'S
JUST NOT FEASIBLE.
SO THINKING ABOUT THE
FEASIBILITY AND FEASIBILITY IS
WHAT DOES IT COST, HOW DO YOU
FIND PEOPLE, HOW DO YOU
RETURN -- IT'S REALLY IMPORTANT
TO KIND OF THINK ABOUT THIS
ISSUE OF FEASIBILITY WHEN YOU'RE
DESIGNING YOUR STUDY, AND THEN
THINKING ABOUT WHAT THE VALUE IS
TO THE PARTICIPANTS.
SO WE HAD KIND OF, I THINK, SOME
RECOMMENDATIONS THAT MAYBE KIND
OF COME OUT OF THIS, THIS
DISCUSSION, SO ONE OF THEM IS
BEFORE THE RESEARCH BEGINS
GETTING PARTICIPANT INPUT INTO
KIND OF ALL ASPECTS OF RETURN OF
RESULTS, WHAT DO THEY WANT, HOW
DO THEY WANT IT, WHAT ARE THEY
INTERESTED IN, WHAT'S THEIR
VALUES, WHAT ARE THE BENEFITS
AND HARMS TO THEM, AND THAT'S
PART OF THIS WHOLE COMMUNITY
ENGAGEMENT IS REALLY ENGAGING
THE COMMUNITY AHEAD OF TIME.
COMMUNITIES ARE GOING TO BE
DIFFERENT.
NOT EVERY COMMUNITY IS GOING TO
HAVE THE SAME CONCERNS.
SO THAT'S KIND OF GETTING
PARTICIPANT VIEWS AHEAD OF TIME,
AND THE OTHER IS TO JUST BE SURE
THAT YOU PROSPECTIVELY HAVE A
PLAN OF HOW TO RETURN RESULTS
ABOUT WHAT YOU'RE GOING TO --
WHAT ARE THE RESULTS, WHAT ARE
UNEXPECTED RESULTS, HOW ARE YOU
GOING TO HANDLE KIND OF BOTH
CATEGORIES OF RESULTS BEFORE YOU
GO INTO A STUDY.
THE NEXT PIECE OF IT IS REALLY
STUDYING THE RETURN OF RESULTS
AS AN ENTERPRISE IN AND OF
ITSELF.
AND I THINK KYLE KIND OF
MENTIONED THIS, THE IDEA OF NOW
YOU'RE RETURNING RESULTS, LET'S
GET THE OUTCOMES.
A LOT OF US, I THINK, IN THE
ROOM WHO HAVE WORKED IN GENETICS
HAVE SPENT A LOT OF TIME DOING
SURVEYS AND INTERVIEWS AND
INTERACTING WITH PARTICIPANTS
AFTER THEY'VE ACTUALLY GOTTEN
RESULTS BACK OR HAVE BEEN IN A
STUDY AND HAVEN'T GOTTEN RESULTS
BACK TO REALLY LOOK AT WHAT THAT
LOOKS LIKE, WHAT ARE THE IMPACTS
ON PARTICIPANTS, ALSO WHAT ARE
THE IMPACTS ON CLINICIANS, ON
THE HEALTHCARE SYSTEM, THE
ECONOMIC IMPACTS, THE FAMILIES,
I MEAN, IT'S REALLY THE COMEUNT,
IT'S REALLY EVERYBODY.
SO THE IMPORTANCE OF DESIGNING
STUDIES TO LOOK AT WHAT THOSE
ARE.
FINALLY SOMETHING ABOUT THE
WHOLE REGULATORY PIECE OF IT, I
THINK A LOT OF WHAT ADAM TALKED
ABOUT, UNDERSTANDING, ONE THE
PARTICIPANTS MENTIONED THAT
REGULATIONS VARY AT DIFFERENT
INSTITUTIONS AND ALL THE ECHO
STUDIES, THERE MAY BE DIFFERENT
KIND OF ASPECTS OF THE
REGULATIONS AND JUST HOW DOES
THAT FIT INTO WHAT YOU'RE
RETURNING.
AND AGAIN, GENETICS IS A LITTLE
BIT PROBABLY OF A CONCRETE SPACE
AND SO WE HAVE THIS VERY CLEAR
LABORATORY TESTS, FDA, HAVE TO
CLIA-CONFIRM SOMETHING BEFORE
YOU RETURN IT, THAT TYPE OF
THING, AND JUST UNDERSTANDING
WHAT THE REGULATORY REQUIREMENTS
ARE GOING TO BE IN -- KIND OF IN
YOUR STUDIES.
SO THAT'S MY KIND OF TRYING TO
BRING EVERYTHING TOGETHER, AND
I'M HAPPY IF I DON'T KNOW IF
KYLE, JEFF OR ADAM, ANYTHING YOU
WANT TO SAY IN PARTICULAR,
TAKE-HOME MESSAGES OR TAKE ANY
QUESTIONS.
>>THANKS, INGRID.
I THINK WE'LL MOVE TO THE OPEN
DISCUSSION NOW.
>>HOW ABOUT INVITING OUR
SPEAKERS AND OUR DISCUSSANT TO
SIT AT THE HEAD TABLE?
>>YES, THAT WOULD BE GREAT.
>>KYLE, JEFF, ADAM?
ONE OF THE THINGS YOU MAY HAVE
NOTICED IN THE AGENDA IS WE'VE
CARVED OUT LOADS OF TIME FOR
DISCUSSION BECAUSE WE THINK
THAT, YOU KNOW, THE TALKS ARE
THINGS TO SORT OF GENERATE YOUR
IDEAS, AND THIS IS WHERE A LOT
OF THE MEAT OCCURS, AND WE
REALLY GET TO A LOT OF THESE
ISSUES THAT WILL HELP US DERIVE
OUR RECOMMENDATIONS GOING
FORWARD.
SO HOPING FOR REALLY LOTS OF
MEATY DISCUSSION DURING THESE
DISCUSSION PERIODS.
>>AND IF ANYBODY ONLINE HAS
QUESTIONS, GO AHEAD AND PUT THEM
IN THE Q & A.
SOUNDS LIKE THERE MIGHT ALREADY
BE SOME.
>>YES.
THE FIRST QUESTION IS A TWO-PART
QUESTION.
DOES REPORTING INCIDENTAL
FINDINGS TO A PARTICIPANT
QUALIFY AS REPORTING
PATIENT-SPECIFIC RESULTS SUCH
THAT A RESEARCH LAB NO LONGER
QUALIFIES FOR THE EXCEPTION?
SO IF YOU INTEND TO PROVIDE
INCIDENTAL FINDINGS, EVEN IF
NONE END UP OCCURRING, DO YOU
HAVE TO USE A CLIA-CERTIFIED LAB
OR ASSAYS?
>>SO I'LL BE THE FIRST TO CHIME
IN, I GUESS.
THE REGULATIONS DON'T ACTUALLY
DIFFERENTIATE BETWEEN WHETHER
THEY'RE INCIDENTAL OR PRIMARY
RESULTS.
SO IF YOU'RE RETURNING
INCIDENTAL FINDINGS, YOU'RE
RETURNING FINDINGS.
THE QUESTION IS WHETHER OR NOT
YOU'RE UNDER THE REQUIREMENT OR
NOT GG IS GOING TO DEPEND ON TE
CONTEXT ORIS BEING IF THEY'RE
GOING TO COME IN.
IF YOU'RE LOOKING UNDER -- YOU
HAVE TO CONSIDER CLIE YA
REQUIREMENTS, YOU'RE GOING TO
HAVE TO CONSIDER FDA FINDINGS AS
WELL SO FINDINGS ARE -- ALL KIND
OF WORK TOGETHER.
>>I JUST WANTED TO EMPHASIZE
SOMETHING INGRID HINTED AT,
WHICH IS THERE'S A PROCESS IN
GENOMICS FOR GENERATING SORT OF
AN INITIAL FINDING OFTEN IN SORT
OF A MORE KIND OF CUTTING EDGE
TECHNOLOGY THAT IT'S NOT CLIA
CERTIFIED, IT'S SORT OF NOWHERE
NEAR FDA EVALUATION, BUT IT'S A
RESEARCH TYPE OF THING, AND THEN
USING THAT INFORMATION TO THEN
TAKE TO A MORE STANDARD
TECHNOLOGY THAT HAS BEEN
FDA-VALIDATED THAT IS OPERATED
IN A CLIA SETTING, AND USING
THAT INFORMATION TO RETURN, AND
SO I THINK ONE QUESTION THAT WE
SHOULD KEEP OPEN AND THINKING
ABOUT THESE OTHER KINDS OF
RESULTS IS ARE THERE WAYS TO
SORT OF DO A TWO-STEP PROCESS,
AND I THINK -- ADAM, YOU SHOULD
REALLY WEIGH IN HERE, THE
INTERPRETATION IS OFTEN THAT AS
LONG AS I'M GENERATING THE
FINDINGS SORT OF NOT IN A CLIA
ENVIRONMENT BUT I HAVE A PROCESS
TO CLIA VERIFY IT BEFORE IT
ACTUALLY GOES TO A PATIENT OR
HEALTHCARE PROVIDER OR
SOMETHING, THAT THAT IS PROBABLY
OKAY.
BUT IF THAT PROCESS REQUIRES ME
TO TAKE THAT SORT OF UNCERTAIN
INFORMATION, RETURN TO A
PARTICIPANT, THEN THE
PARTICIPANT NEEDS TO GO TO A
HEALTHCARE PROVIDER TO GET IT
VERIFIED, THAT'S PROBABLY
PROBLEMATIC FROM A CLIA
PERSPECTIVE.
>>THE IDEA OF CONFIRMATORY
TESTING IS A BIG ONE, AND THAT'S
ACTUALLY BEEN USED IN THE
GENETICS SPACE FOR A LONG TIME,
WHICH IS THINKING ABOUT
CLINICALLY ACTIONABLE RESULTS TO
BE RETURNED.
I THINK THE ONLY PROBE THAT
COMES IN WITH IT IS MANY TYPES
OF TESTS MAY NOT BE ABLE TO BE
CONFIRMED IN A CLIA CERTIFIED
LAB.
SO WHAT DO YOU DO ABOUT THOSE?
AND I'M NOT SAYING I HAVE AN
ANSWER FOR THIS BUT THAT'S JUST
ONE OF THOSE CAVEATS THAT COMES
IN WITH WHAT YOU'RE TRYING TO
RETURN.
BUT I AGREE WITH THE REST OF
WHAT YOU STATED, IF YOU ARE
GOING TO CONFIRM IT BEFORE
RETURNING, IT'S ACTUALLY BEING
RETURNED OUT OF THE CLIA LAB,
THERE ARE NO PROBLEMS WITH DOING
THAT.
>>I GUESS I WOULD SAY THAT THIS
IS SUCH A HUGE AREA OF
COMPLEXITY AND DEBATE.
AND I WOULD MAKE SOME
DISTINCTION BETWEEN SO-CALLED
SECONDARY RESULTS THAT YOU KNOW
YOU'RE GOING TO GET, THEY'RE NOT
WHAT YOU'RE REALLY LOOKING TO
FOR, THE PURPOSE OF THE
RESEARCH, BUT THEY'RE
ANTICIPATABLE FINDINGS, THEN
THERE'S TRULY UNANTICIPATABLE
FINDINGS.
CMS HAS BEEN QUITE CLEAR ABOUT
THIS TO SAY ANY RESPONSE TO
RESEARCH RESULTS AND
COMMUNICATION OF ANY RESULTS TO
PARTICIPANTS IS PROHIBITED IN A
NON-CLIA LAB.
AND THAT MEANS SAYING WE FOUND
SOMETHING BUT WE NEED A NEW
SAMPLE TO BE CONFIRMED IN A CLIA
LAB BEFORE WE CAN GIVE YOU
SPECIFIC RESULTS.
I THINK THAT'S WHAT
INVESTIGATORS ARE COMMONLY
DOING.
I THINK SACHARP AND THE NATIONAL
ACADEMY SAID THAT'S ETHICALLY
APPROPRIATE.
I THINK IF YOU TIE THE
REGULATORS DOWN, THEY WILL SAY
THAT'S NOT CONSISTENT WITH THE
REGS, BUT AT THE SAME TIME, I'M
NOT AWARE THAT THEY'RE
SANCTIONING ANYBODY FOR WHAT IS
COMMONLY GOING ON OUT THERE.
SO I THINK IT'S STILL A AREA
THAT NEEDS TO BE THOUGHT THROUGH
IN THE CONTEXT OF EACH
LABORATORY ANALYSIS THAT YOU'RE
DOING AND WHETHER YOU'RE GOING
TO GET SECONDARY OR
UNANTICIPATED RESULTS AND HOW
YOU'RE GOING TO DEAL WITH THOSE.
>>TWO POINTS.
FOR THOSE OF US WHO ARE HEARING
IMPAIRED CAN I ASK PEOPLE TO
KEEP THE MICROPHONES CLOSE TO
THEIR MOUTHS?
IT'S REALLY HARD TO HEAR IN THE
ROOM.
BUT I ALSO WANTED TO KNOW FROM
THE LEGAL PERSPECTIVE, IF YOU'RE
TALKING ABOUT PARTNERED
RESEARCH, CAN IT BE WRITTEN INTO
A CONSENT FORM THAT IN SOME WAY
MAKES THAT MORE OF A CONTRACTUAL
OBLIGATION IF YOU'RE SEEN AS
PARTNERING WITH THE COMMUNITY
AND WITH THE PARTICIPANTS IN
GENERATING THOSE RESULTS AND THE
PARTICIPANTS ARE SIGNING OFF ON
SOMETHING THAT THEY EXPECT A
RESPONSE FROM THAT?
HOW WOULD THAT -- IS THAT ONE
STRATEGY TO MAYBE TRY AND -- I
MEAN, CHANGING REGULATIONS IS 50
YEARS DOWN THE ROAD.
SO WHAT I'M LOOKING FOR IS, IS
THERE A WAY WE COULD HAVE A
STOPGAP MEASURE THAT WOULD MEET
THE LEGAL REQUIREMENTS AND
RESPECT THE PARTICIPANTS AND THE
RESEARCHERS NEED TO RETURN
RESULTS?
>>I'M GOING TO ANSWER A
SLIGHTLY DIFFERENT QUESTION AND
IT MORE ABOUT THE PARTNERING,
BECAUSE I THINK THERE IS --
THERE ARE PATHWAYS THAT CAN BE
TAKEN.
SO THE REGULATIONS APPLY TO THE
LAB AND THE PURPOSE OF THE
TESTING.
OTHER AGREEMENTS AREN'T
NECESSARILY GOING TO FACTOR INTO
THAT, BUT THERE ARE PATHWAYS
THAT CAN BE TAKEN.
AS A RESEARCH LAB, YOU CANNESE
LEGAL PARTNER WITH SOME OTHER
LABORATORY THAT IS CLIA
CERTIFIED TO HAVE THOSE TESTS
RUN THERE.
AND IT COULD BE A RESEARCH LAB
THAT'S CLIA CERTIFIED, IT COULD
BE A CLINICAL LAB THAT'S CLIA
CERTIFIED.
THOSE DIFFERENT PATHWAYS ARE
AVAILABLE FOR THE RESEARCH
ITSELF TO TAKE PLACE.
SO IF YOU'VE GOT -- I'M NOT SURE
WHO'S SITTING AROUND THE ROOM
THAT'S AT A CLIA LAB, BUT A
RESEARCHER THAT'S BEEN A
NON-CLIA CERTIFIED LAB THAT
WANTS TO DO TESTING COULD
PARTNER WITH SOMEBODY ELSE WHO
IS A CLIA CERTIFIED LAB AND HAVE
THOSE RESULTS CREATED THERE, AND
THEN RETURN FROM THAT
LABORATORY, THAT WOULD ACTUALLY
MEET THE REQUIREMENTS.
SO THERE ARE DIFFERENT PATHWAYS
THAT COULD BE TAKEN, EVEN IF
YOU'RE NOT CLIA CERTIFIED
YOURSELF.
>>BUT THE CLIA LABORATORY WAS
ONLY ONE PART OF THE REGULATIONS
THAT YOU WENT THROUGH THAT
PROHIBITED THAT RETURN.
SO WONDERED FOR THOSE OTHER,
LIKE SOME OF THE HIPAA AND THE
CMS, ARE THOSE -- WOULD THOSE
STILL QUALIFY IF YOU HAD A CLIA
CERTIFIED LAB?
BECAUSE SOME OF THE RESULTS
OBVIOUSLY ARE NOT GOING TO GO
THROUGH A LABORATORY.
AND IT SOUNDED LIKE THERE WERE
LIMITATIONS BEYOND THE LAB
RESULTS.
OR DID I MISUNDERSTAND THAT?
>>SO HIPAA IS GOING TO APPLY TO
A COVERED ENTITY, AND THOSE ARE
THOSE ENTITIES THAT I LISTED UP
THERE THAT ARE DOING SOME SORT
OF ELECTRONIC TRANSACTION THAT'S
ACTUALLY GOT A STANDARD THAT'S
BEEN SET.
SO TO BOIL THAT DOWN, LIKE I
SAID, THE EHR IS GENERALLY GOING
TO FALL WITHIN THE SCOPE OF THE
DESIGNATED RECORD SET, SO YOU
CAN HAVE ACCESS TO THAT.
THAT'S WHERE HIPAA COMES IN.
HIPAA IS NOT ACTUALLY REGULATING
THE TESTING ITSELF, SO THE
DEVELOPMENT OF THE TEST AND THE
RESULTS INDIVIDUALLY.
IT'S TALKING ABOUT WHATEVER IS
COLLECTED AS PART OF THE
DESIGNATED RECORD SET, THAT'S
WHERE HIPAA IS GOING TO COME IN.
I KNOW IT'S COMPLICATED AND
THERE ARE NUANCES BETWEEN WHERE
ALL THESE INTERSECT AND WHERE
THEY DON'T, EVEN WHERE YOU DON'T
HAVE CLIA COMING IN, IT COULD BE
THAT THERE'S REQUIREMENTS UNDER
FDA FOR THE ACTUAL TEST ITSELF,
SO IT JUST DEPENDS ON WHAT
ASPECT YOU'RE COMING IN AT WILL
DETERMINE WHERE AND WHAT
REGULATIONS ARE GOING TO APPLY.
>>I WAS JUST GOING TO VERIFY,
SO IF RESEARCH TESTING GETS
DEPOSITED INTO THE ELECTRONIC
HEALTH RECORD, THE PARTICIPANTS
ARE GOING TO BE ABLE TO ACCESS
THAT AS A PART OF THE ELECTRONIC
HEALTH RECORD.
THAT'S WHAT BASIC -- THAT'S WHAT
HIPAA REQUIRES.
SO THAT IS ACCESSIBLE AND
THERE'S NO SORT OF DEBATE ABOUT
WHETHER WE'RE GOING TO NOT LET
YOU HAVE IT.
IT'S YOUR ELECTRONIC MEDICAL
RECORD, HIPAA SAYS YOU CAN
ACCESS IT.
ON THE OTHER HAND, YOUR QUESTION
ABOUT CAN I GET CONSENT FROM A
PERSON TO GIVE THEM BACK
INFORMATION AND HIPAA NOT APPLY,
ABSOLUTELY, THAT HAPPENS ALL THE
TIME.
SO IT'S IN THE CONSENT, WE'RE
GOING TO GIVE YOU THIS
INFORMATION, EVEN IF THERE WAS
SOME KIND OF HIPAA BOUNDARY
AROUND IT, YOU NOW HAVE AN
AUTHORIZATION IF THAT PERSON IS
THE LEGALLY -- IS A LEGAL
REPRESENTATIVE TO GET PERMISSION
FOR THAT INFORMATION TO BE
RELEASED, THEN THEY CAN RECEIVE
IT.
BUT YEAH.
>>JULIA?
>>I THOUGHT ONE OF THE
STRENGTHS OF THE 2018 REPORT WAS
THAT IT ACKNOWLEDGED THAT
THERE'S A WHOLE WORLD OF
ENVIRONMENTAL RESEARCH GOING ON
THAT'S NOT CLINICALLY RELEVANT
AND CALLED UPON IRBs AND
INSTITUTIONS AND RESEARCHERS TO
TAKE RESPONSIBILITY FOR QUALITY
ISSUES.
I DON'T KNOW WHERE ALL THE ECHO
TESTING TAKES PLACE, BUT
CERTAINLY THE ENVIRONMENTAL
HEALTH FIELD IS USING MANY
ACADEMIC LIBRARIES OUTSIDE OF
THE CLIA REGULATORY SCHEME AND
PEOPLE WANT THOSE RESULTS, THE
ACTIONS ARE NOT CLINICAL IN
RESPONSE TO THOSE RESULTS.
AND I THOUGHT IT WAS A STRENGTH
OF THE 28 REPORT THAT IT
ACKNOWLEDGED THAT THAT NEEDS TO
BE ADDRESSED.
>>THANK YOU.
I DON'T THINK I WOULD HAVE TOO
MUCH MORE TO SAY THERE, AND I
SUSPECT THIS IS GOING TO BE A
LONG-TERM EVOLUTIONARY PROCESS.
FROM THE STANDPOINT OF ECHO.
I GUESS THE QUESTION WOULD BE
HOW DO YOU AS A CONSORTIUM
DECIDE WHETHER A PARTICULAR
LABORATORY HAS SUFFICIENT
QUALITY STANDARDS TO LIVE UP TO
THE RETURN OF RESULTS.
AND LIKE THIS QUESTION OF RETURN
OF RESULTS, PROB BLIP MAY WELL
BE A PROCESS IN PLACE WHERE
FOLKS ARE LOOKING AT THAT
QUESTION AND MAKING SELECTIONS
OF LABS ON A BASIS OF THE
QUALITY ISSUE.
I DON'T THINK THAT NECESSARILY
GETS YOU AROUND CLIA FOR THE
HUMAN SPECIMENS, BUT AS ADAM
SAYS, IT'S NOT -- CLIA IS NOT
DIRECTLY RELEVANT TO
ENVIRONMENTAL SAMPLES BUT
OBVIOUSLY FROM AN ETHICAL
STANDPOINT, THE SAME PRINCIPLES
EXIST THAT YOU NEED TO LOOK TO
LAB QUALITY TO MAKE SURE YOU'VE
GOT VALID ANSWERS TO YOUR
QUESTIONS.
>>CLIA APPLIES TO HUMAN
SPECIMENS, FOR THE PURPOSE OF
DIAGNOSIS, PREVENTION -- OF AB
ABNORMALITIES.
IT SETS THE MINIMUM BAR FOR THAT
TESTING.
IT'S SOMETHING TO THINK ABOUT
FOR ECHO AND ENVIRONMENTAL
HEALTH, IS THERE AN EQUIVALENCE
FROM AN ENVIRONMENTAL HEALTH
STANDARDS ASPECT, IS THERE AN
EQUIVALENT BAR THAT HAS BEEN
ESTABLISHED, STANDARDS THAT THE
FIELD ADHERES TO.
I MEAN, IT MAY NOT COME UNDER
CLIA, BUT AS THE REPORT ACTUALLY
PUT OUT, THERE'S A CONCEPT OF
QUALITY OF TESTING THAT STILL
NEEDS TO BE ASSURED EVEN FROM A
RESEARCH LAB TO BE ABLE TO
RETURN, NOW HE, IS THERE
SOYOU KNOW, IS THERESOMETHING AN
THE ENVIRONMENTAL HEALTH SPACE
OR IS IT ADHERED TO BY TESTING
GROUPS.
>>MATT, DID YOU HAVE A COMMENT
RELATED TO THAT?
>>YES, THERE WAS SOMEBODY
BEFORE ME.
>>YOU WANT TO GO?
OKAY.
>>SO THANK YOU FOR THESE TALKS.
LET ME PULL TOGETHER A FEW
THREADS THAT I HEARD THAT FEEL
LIKE THEY'RE A LITTLE BIT
INTENTION AND I WANT TO HEAR HOW
YOU WORK THIS THROUGH.
SO ON THE ONE HAND, THERE'S THIS
GENERAL LITERATURE THAT RESEARCH
PARTICIPANTS WANT FINDINGS,
PEOPLE IN GENERAL WANT FINDINGS.
THERE'S THIS EMERGING IDEA THAT
PARTICIPANTS ARE PARTNERS
ACTUALLY THAT YOU SEE IN ECHO,
IN THE ALL-OF-US PROGRAM, AND
THERE'S THIS PROBLEM OF FIGURING
OUT WHAT VALUE IS AND HOW DO YOU
FIGURE THAT OUT, WELL, ONE OF
THE WAYS TO DO THAT IS TO ASK
PEOPLE.
SO THERE'S A LOT MORE
ENGAGEMENT, THERE'S A LOT MORE
SORT OF TALKING TO THE
PARTICIPANTS, THE PARTNERS,
ABOUT WHAT THEY WANT.
ON THE OTHER HAND, RESEARCH HAS
LIMITED RESOURCES.
YOU CAN'T HAVE AN OPEN-ENDED
OFFER OF RETURNING EVERYTHING.
THERE HAS TO BE SOME LIMITS TO
THAT.
FIGURING OUT WHAT IS FEASIBLE,
WHAT IS VALUABLE, IF YOU OFFER
TOO MUCH, THERE ARE GOING TO BE
OPPORTUNITY COSTS.
I THINK, JEFF, YOU GAVE THE
EXAMPLE OF THE MOTHER WHO WAS
LIKE WELL, I WANT EVERYTHING BUT
NOT IF IT TAKES AWAY FROM YOUR
ABILITY TO FIGURE OUT WHAT'S
GOING ON WITH MY KID'S DISEASE.
SO HOW DO YOU SORT OF MARRY
THOSE TWO IDEAS THAT SEEM LIKE
THEY'RE IN TENSION?
YOU CAN ASK PEOPLE, YOU CAN
ENGAGE WITH PARTICIPANTS, YOU
CAN SORT OF OFFER THEM AN
OPEN-ENDED MENU OF CHOICES, BUT
THEN YOU CAN'T ACTUALLY DELIVER
ON THAT PROMISE BECAUSE YOU HAVE
TO DRAW SOME LINES AS A RESEARCH
PROGRAM.
SO HOW DO YOU HAVE THAT
CONVERSATION WHERE YOU WANT TO
GET THEIR INPUT BUT YOU'RE AT
THE SAME TIME SAYING WE CAN'T
GIVE YOU EVERYTHING?
>>GREAT QUESTION.
AND I WOULD GO BACK TO A COMMENT
I MADE AND SOME OF THE WORK
WE'VE DONE IN PAST YEARS WITH
TRYING TO DEVELOP A PROCESS
CALLED DELIVERTIVE FOCUS GROUPS.
THE NOTION IS, YOU DON'T ASK
SIMPLISTIC QUESTIONS AND NOT TO
CAST ANY ASPERSIONS ON SOCIAL
SCIENCE COLLEAGUES BECAUSE THEY
KNOW THE SOPHISTICATIONS HERE
BUT MAYBE THAT'S A SEPARATE
POINT, WHEN YOU DO THIS STUFF,
YOU WANT PEOPLE WHO KNOW WHAT
THEY'RE DOING WITH RESPECT TO
SOCIAL SCIENCE RESEARCH.
BUT YOU CAN'T ASK SIM POLICE TI
QUESTIONS LIKE WHAT RESEARCH
RESULTS DO YOU WANT OR DO YOU
WANT EVERYTHING, BECAUSE THE
ANSWER MAY WELL BE SURE, OF
COURSE I WANT EVERYTHING.
BUT THEN WHEN YOU SIT DOWN AND
SAY OKAY, HERE'S WHAT EVERYTHING
MEANS, HERE ARE THE IMPLICATIONS
OF TRYING TO TAKE THAT STANDARD,
HERE ARE THINGS THAT REALLY
MIGHT BE CRITICALLY USEFUL FOR
YOU, HERE ARE THINGS THAT MIGHT
BE LESS USEFUL.
HOW DO WE DRAW LINES AROUND WHAT
REALLY OUR RESPONSIBILITIES ARE
AS A RESEARCH TEAM.
AND I THINK YOU GET REASONABLE
ANSWERS OUT OF PEOPLE.
SO AS LONG AS YOU HAVE THAT PART
OF THE ENGAGEMENT TO SAY IT'S
NOT JUST AN OPEN FIELD THAT
YOU'RE GOING TO GET EVERYTHING
BECAUSE THAT IS TOO MUCH OF A
BURDEN ON THE RESEARCH
ENTERPRISE AND YOU'RE NOT GOING
TO GET MUCH RESEARCH DONE.
LET'S REALLY FOCUS ON WHAT'S
MOST IMPORTANT TO MEEM AND
PEPEOPLE ANDPEOPLE WILL UNDERST,
AND ACCEPT THAT.
>>I THINK -- IF YOU THINK ABOUT
THE SPECTRUM OF POLICIES YOU
MIGHT TAKE, YOU KNOW, YOU COULD
SAY WELL, WE'RE NOT GOING TO
RETURN ANYTHING.
AT THE OTHER END, YOU COULD SAY
WE'RE GOING TO JUST PUT -- LIKE
BUILD A BIG DATABASE, AND YOU
CAN JUST GO OP LI ONLINE AND LOT
YOUR DATABASE.
FORGIVE ME I'M A PEDIATRICIAN,
FROM THE MOVIE INYESTERDAYIBLES,
IF EVERYBODY IS SUPER, NOBODY
IS.
SO IF I GIVE INFORMATION TO A
PARTICIPANT OR A PATIENT AND
IT'S ALL JUK, NONE OF JUNK, NONS
HELPFUL.
DIRECT-TO-CONSUMER, GENETIC
TESTING AND THINGS, THOSE FOLKS
GET THAT INFORMATION AND THEY
TRY TO FIND A PROFESSIONAL TO
HELP THEM INTERPRET IT BECAUSE
THEY DON'T KNOW WHAT TO MAKE OF
IT.
SO THEN YOU THINK ABOUT, WELL,
MAYBE EVERYTHING IS -- WE COULD
MAKE IT POSSIBLE TO GET AT
EVERYTHING BUT THAT'S REALLY NOT
HELPING ANYBODY DIRECTLY, SO YOU
THINK ABOUT SORT OF HOW DO WE
BUILD A STRATEGY THAT SORT OF
GIVES FOLKS THE IDEA THAT
THEY'RE GETTING THINGS THAT ARE
HELPFUL TO THEM, BUT WE'RE
GIVING IT TO THEM IN A WAY THAT
HELPS THEM FOCUS ON WHAT'S MOST
IMPORTANT AND WHAT ARE THE
ACTIONS THAT THEY COULD TAKE,
AND THEN YOU'RE REALLY I THINK
GETTING BACK TO WHAT YOU WERE
POINTING OUT THAT THAT TAKES
RESOURCES.
>>JUST TO SUMMARIZE, IT SOUNDS
LIKE YOU NEED CURE RANGE OF
MOTION FROM BOTH ENDS.
YOU NEED THE INPUT OF THE
PARTICIPANTS TO EXPRESS WHAT
THEY WANT, BUT YOU ALSO NEED THE
RESEARCH TEAM TO SORT OF BE
GUIDING PEOPLE TOWARDS WHAT
INFORMATION WILL BE MOST
VALUABLE TOWARDS THEM.
IT HAS TO BE SORT OF A TWO-WAY
STREET.
>>MATT?
>>THIS IS A GREAT DISCUSSION.
THANKS.
FOR THE AUDIENCE AND FOR OUR
PANEL MEMBERS.
SO I'D LIKE TO SORT OF BROADEN
WHAT WE MEAN BY ENVIRONMENT, SO
IN ECHO, WHEN WE SAY
ENVIRONMENTAL INFLUENCES, WE
MEAN EVERYTHING FROM SOCIETY TO
BIOLOGY.
AND A LOT OF THE DISCUSSION HERE
HAS BEEN ON SPECIMENS, SO BODILY
FLUIDS AND OTHER THINGS WE TAKE
OUT OF PEOPLE, OR MAYBE EVEN
THINGS THAT WE MONITOR IN OUR
MACRO ENVIRONMENTS, THINKING
ABOUT TOXIC CHEMICALS.
BUT IN ECHO, WE ALSO THINK ABOUT
SELF REPORTS.
PERSON REPORTED OUTCOMES.
WE THINK ABOUT PHYSICAL EXAM
MEASUREMENTS, WE THINK ABOUT ALL
OF THESE THINGS AS PART OF THE
ENVIRONMENT.
SO DO THE ETHICAL PRINCIPLES
DIFFER, AND DO THE REGULATIONS
OR LAWS DIFFER WHEN YOU'RE
TALKING ABOUT SELF REPORTS AND
PHYSICAL MEASUREMENTS AS OPPOSED
TO LABORATORY RESULTS?
>>SO I'LL COMMENT, YOU'RE GOING
TO HEAR THE SAME MANTRA I'VE
LISTED BEFORE, WHICH IS CLIA
APPLIES TO HUMAN SPECIMENS, AND
SO OTHER SAMPLES THAT YOU'RE
GOING TO GET FROM THE
ENVIRONMENT, WHETHER YOU'RE
TALKING ABOUT AIR, SOIL, WATER,
NOT GOING TO BE REGULATED BY
CLIA.
THE OTHER THING YOU'RE TALKING
MORE ON THE SOCIAL CONTEXT, AND
IT'S AN INTERESTING QUESTION IN
TERMS OF WHAT IS THE -- WHAT ARE
THE REGULATORY ASPECTS THAT
APPLY THERE, I'M NOT AWARE OF
CLIA OR ANY FDA REGULATIONS
APPLYING TO THOSE.
THAT DOESN'T MEAN THAT THERE
MIGHT NOT BE SOME OTHER
REGULATORY BODY THAT WOULD APPLY
TO THAT, BUT IN GENERAL, IF YOU
AS THE PARTICIPANT ARE SUPPLYING
THE INFORMATION, YOU ALREADY
HAVE THAT.
SO YOU SHOULD BE ABLE TO RETAIN
ACCESS TO THAT INFORMATION
REGARDLESS OF WHERE YOU'RE
STORING IT.
I THINK IF YOU'RE ALSO TALKING
ABOUT OTHER TYPES OF BUILT
ENVIRONMENT ASPECTS OR WHATNOT,
ALL THAT'S PUBLIC DATA ALREADY,
SO IF IT'S PUBLIC, IT'S PUBLIC,
RIGHT?
SO IF YOU'RE TALKING ABOUT HOW
MANY SUPERMARKETS ARE IN A
NEIGHBORHOOD, THAT'S PUBLIC
DATA.
SO THERE ISN'T A REGULATORY
ASPECT THAT WOULD KEEP PUBLIC
INFORMATION -- INFORMATION
THAT'S ALREADY PUBLIC FROM STILL
BEING PUBLIC IN THAT REGARD.
I DON'T KNOW IF THAT'S GETTING
TOWARDS WHERE YOU WERE MEANING
FROM AN -- BROADENING THE
ENVIRONMENTAL SPOT, BUT THOSE
ARE JUST SOME CONSIDERATIONS TO
THINK ABOUT.
>>I MEAN, WE ALSO MEAN
BEHAVIORS.
WHAT'S YOUR DIET?
OR A SCALE OF DEVELOPMENT OR A
SCALE OF MENTAL HEALTH OR
SOMETHING LIKE THAT.
SO --
>>ALSO IF YOU'RE MEASURING LIKE
CHEMICALS AND DUST, YOU KNOW,
SOMETHING LIKE THAT, THAT SEEMS
TO BE KIND OF -- NOBODY KNOWS.
>>SO BROADENING THIS, KIM, TO
SAY IT'S NOT ONLY CHEMICALS BUT
IT'S ALSO SOCIAL, SOCIETAL,
MEDICAL, BEHAVIORAL, IN DISEASE
AS WELL.
>>THAT'S JUST A FASCINATING
QUESTION.
I'M GOING TO GUESS, BUT -- YOU
KNOW, I DON'T KNOW THIS FIELD
VERY WELL, BUT A LOT OF THOSE
ASSESSMENTS ARE SORT OF
ANALOGOUS TO YOUR CLIA CERTIFIED
LABORATORY TESTS.
SO IF YOU'VE GOT A HEIGHT, A
WEIGHT, A HEAD CIRCUMFERENCE AND
DEVELOPMENTAL EVALUATION ALL
BEING CONDUCTED WITH STAND DIED
TESTS, SEEMS TO ME THOSE ARE
STRAIGHTFORWARD TO RETURN TO
PEOPLE.
PROBABLY EVEN THE ONES THAT FALL
WELL WITHIN THE NORMAL RANGE,
BECAUSE YOU'RE WEIGHING THE --
YOU'RE DOING THESE
STRAIGHTFORWARD THINGS THAT A
PEDIATRICIAN WOULD DO, PEOPLE
ARE GOING TO WANT TO KNOW THAT
INFORMATION AND IT'S PROBABLY
RELATIVELY EASY TO SAY.
NOW MAYBE THOSE THINGS THAT ARE
MORE HYPOTHESIS-DRIVEN AT THIS
POINT, AND YOU'VE GOT A
CONSTELLATION OF SOCIAL FACTORS
WHERE YOU'RE GOING TO PREDICT
BEHAVIORAL OUTCOMES IN
ADOLESCENTS, BUT YOU HAVEN'T
VALIDATED THAT YET, I'D BE
CAUTIOUS ABOUT TRYING TO SAY,
WELL, I DON'T KNOW, YOU'RE
FALLING ON THIS SIDE OF THE
SCALE, WE DON'T KNOW WHAT THAT
MEANS YET, BUT IT COULD BE A
PROBLEM.
THAT'S WHERE I THINK YOU'RE
GETTING INTO THINNER ICE IN
TERMS OF RETURNING THAT KIND OF
RESULT WHEN THE OUTCOMES HAVEN'T
BEEN VALIDATED AS OF YET AND
THAT'S THE POINT OF THE
RESEARCH, TO DO THE VALIDATIONS.
>>I COMPLETELY AGREE.
JUST TO ADD TWO OTHER EXAMPLES,
ONE, YOU COULD USE SORT OF A
CLINICAL QUALITY MEASURE FOR
SUICIDALITY, RIGHT?
THE DUTY TO RESCUE CLEARLY COMES
INTO PLAY THERE.
THROUGH MY RESEARCH TESTING, I'M
IDENTIFYING SOMEONE THAT'S IN
IMMINENT HARM, I NEED TO ACT.
SO THE THINK THE ETHICAL
PRINCIPLES THAT I WAS DISCUSSING
CERTAINLY APPLY.
YOU RAISE ANOTHER EXAMPLE WHICH
I THINK IS GREAT ABOUT DIET,
HEALTH BEHAVIORS, ET CETERA.
CERTAINLY THERE ARE OTHER WAYS
PEOPLE ARE AWARE OF THAT.
SO YOU KNOW, YOU'RE DOING IT IN
A MORE STRUCTURED WAY THAN
PROBABLY MOST PEOPLE TRACK THEIR
DIET OR WHATEVER.
BUT WE ALSO KNOW THAT EVEN
THOUGH THERE IS A GREAT DESIRE
TO MAKE THAT KIND OF -- TO HAVE
INTERVENTION TO HELP FOLKS
CHANGE BEHAVIORS, INTERVENE WITH
DIET, EXERCISE, ET CETERA, BUT
THAT IS EXTRAORDINARILY
CHALLENGING, AND THIS IS AN AREA
WHERE THERE HAVE BEEN
INTERVENTIONS TRIED THAT TURN
OUT TO BE MORE HARM THAN GOOD,
TO DO MORE HARM THAN GOOD.
I THINK THAT'S A PERFECT EXAMPLE
OF WHERE THINKING ABOUT BENEFIT
VERSUS HARM AND OPPORTUNITY COST
COMES INTO PLAY.
>>SO LET ME GET A LITTLE MORE
DOWN AND DIRTY.
YOU KNOW, I PARTICIPATE IN YOUR
STUDY.
YOU TOLD ME THAT YOUR STUDY IS
ABOUT MATERNAL DA DIET, OFFSPRIG
OBESITY AND NEURAL DEVELOPMENT.
I KNOW THERE'S SOME RESEARCH OUT
THERE ON THIS ISSUE.
TELL ME WHAT I ATE DURING
PREGNANCY.
TELL ME WHAT MY INTAKE OF
SATURATED FAT WAS.
TELL ME WHAT MY INTAKE OF IODINE
WAS.
WHAT DO YOU SAY AS THE
RESEARCHER?
GIVEN WHAT YOU SAID, KYLE, THAT
WE DON'T KNOW EVERYTHING, WE
KNOW A FEW THINGS, THESE ARE ON
SCALES WHERE THERE'S -- YOU
KNOW, THERE'S SOME VALIDITY BUT
THE MEASUREMENTS AREN'T TOTALLY
VALID BECAUSE WE'RE DOING IT
FROM A FREQUENCY QUESTIONNAIRE
INSTEAD OF MULTIPLE FOOD DIARIES
OR SOMETHING LIKE THAT.
SO WHERE ARE WE IN THESE GREY
AREAS?
>>SOMETHING QUICK, I THINK THE
OTHER PRINCIPLE THAT I THINK IS
COMING OUT TO SOME EXTENT IS
THAT INVESTIGATORS NEED TO BE
CAUTIOUS ABOUT RETURNING RESULTS
THAT WILL NEGATIVELY IMPACT THE
CONDUCT OF THE STUDY.
SO THAT IF YOU'RE GOING TO SAY,
LET SAY, A HIGH CARBOHYDRATE
DIET IN INFANCY WE THINK MIGHT
BE ASSOCIATED WITH SOME ADVERSE
OUTCOME LATER ON, BUT WE DON'T
KNOW THAT, THAT'S WHAT WE'RE
LOOKING AT, BUT YOU CONSISTENTLY
TELL PARENTS ABOUT THE RELATIVE
CARBOHYDRATE INTAKE THAT THEY'RE
FEEDING THEIR KIDS AND PARENTS
THEN CHANGE THEIR BEHAVIOR ON
THAT BASIS, NOW MAYBE YOU'VE
UNDERMINED THE STUDY TO DRAW
VALID INFECTIONS DISEASE
CONCLUSIONS ABOUT THAT BECAUSE
YOU'VE INTERVENED IN A WAY
THAT'S CHANGING THE BEHAVIOR
THAT YOU'RE ACTUALLY STUDYING.
SO THAT'S SORT OF ONE PIECE OF
IT.
BUT TO THE EXTENT THAT YOU KNOW
ALREADY BASED ON PRIOR RESEARCH
THAT CERTAIN DIETARY PATTERNS
HAVE ADVERSE OUTCOMES, THEN I
DON'T SEE A PROBLEM WITH TELLING
PEOPLE AT LEAST THOSE WHO ASKED
TO SAY WELL, HERE'S WHERE YOU
FALL ON THAT SPECTRUM AND HEERTS
WHAT WE KNOW AT THIS POINT ABOUT
THE IMPACTS OF YOUR CURRENT
BEHAVIOR.
MAYBE THAT JUST RAISES ONE MORE
PIECE HERE, WHICH IS THAT THE
NATIONAL ACADEMY REPORT ALSO
WANTED TO THINK ABOUT RESULTS
THAT YOU ROUTINELY OFFER AND
THEN THOSE RESULTS THAT MIGHT BE
AVAILABLE UPON REQUEST.
AND SO THAT MIGHT BE A DIFFERENT
STANDARD TO THINK ABOUT AS WELL.
>>DO WE HAVE ANY QUESTIONS
ONLINE?
>>YES, WE DO.
JUST ONE, I GUESS, IN THE
INTEREST OF TIME.
AFTER CONVEYING AN INDIVIDUAL
PARTICIPANT'S RESULTS OBTAINED
AS PART OF A RESEARCH STUDY AND
THEN A FEW YEARS LATER, OTHER
RESEARCH COMES TO LIGHT WITH AN
OPPOSITE CONCLUSION ABOUT THE
MEANING OF THOSE RESULTS, WHAT
ARE THE ETHICAL OBLIGATIONS FOR
THE RESEARCHERS TO RE-CONTACT
THE PARTICIPANTS AND CONVEY THIS
NEW INTERPRETATION OF THE
PREVIOUS MESSAGE?
>>THIS IS A GREAT QUESTION, AND
YET ANOTHER EXAMPLE WHERE WE DO
HAVE SOME ANALOGS IN GENETICS
THAT MAY HELP US.
SO THERE'S A GUIDANCE FROM THE
AMERICAN SOCIETY OF HUMAN
GENETICS ON THIS EXACT QUESTION
WHEN THAT INFORMATION IS
GENETIC.
WE DID TESTING, WE TOLD YOU SOME
INFORMATION, MAYBE WE DECIDE
LATER THAT MORE COULD BE SAID
ABOUT THAT INFORMATION, OR MAYBE
EVEN WHAT WE TOLD YOU WAS WRONG,
THERE'S A CHANGE IN THE
INFORMATION.
AND IN GENERAL, THE GUIDANCE
FROM THE AMERICAN SOCIETY OF
HUMAN GENETICS IS THAT DURING
THE COURSE OF A RESEARCH STUDY,
WHERE SORT OF THE RESOURCES ARE
IN PLACE TO DO THIS WORK, THAT
THOSE RESOURCES SHOULD INCLUDE
THE ABILITY TO DO THAT.
BUT THAT BECAUSE PAST THE END OF
A STUDY, THE FEASIBILITY OF
DOING THAT PLUMMETS, THEN
THERE'S SORT OF A DROPOFF THERE
IN THE DUTY TO BE ABLE TO DO
THAT.
IF IT POSSIBLE TO CREATE SORT OF
INFRASTRUCTURE THAT CONTINUES
THE ABILITY TO DO THAT INTO THE
LONG TERM, THEN THAT WOULD
REALLY BE WONDERFUL BUT OF
COURSE THAT'S UNUSUAL.
>>JUST ONE OTHER POINT?
THIS IS ACTUALLY NOT EVEN A
SPECIFIC ISSUE WITH RESEARCH.
THIS IS ALSO PRESENT IN MEDICAL
PRACTICE.
PEOPLE MOVE ALL THE TIME, THEY
CHANGE THEIR PRACTITIONERS, THEY
MOVE OUT OF STATE, THEY CHANGE
THEIR HEALTHCARE INSURANCE.
THIS REMAINS A GENERAL QUESTION
OF HOW DO YOU ACTUALLY RECONTACT
FOLKS WHEN YOU HAVE NEW
INFORMATION AND RELEVANT.
I THINK WHAT KYLE SAID IS RIGHT,
THE FEASIBILITY DROPS OVER TIME.
I JUST WANT TO RAISE THE IDEA
THAT THAT IS ACTUALLY BROADER
THAN JUST A RESEARCH AREA OR
ISSUE.
>>JUST ONE MORE Q & A?
>>YES.
THIS ONE IS, I THINK, MOST
DIRECT.
CAN YOU CLARIFY WHETHER HUMAN
BIOMONITORRING SAMPLES, EXAMPLE,
URINE, TESTED FOR EMERGING
CONTAMINANTS OF CONCERN ARE
COVERED UNDER CLIA?
SPECIFICALLY, IF THE EXPOSURE
HAS NO GUIDELINE LEVEL THAT
WOULD ENABLE TO BE USED FOR
DIAGNOSIS, PREVENTION OR
TREATMENT OF DISEASE, BUT SOME
INFORMATION IS KNOWN THAT THE
EXPOSURE GENERALLY COULD HAVE
POTENTIAL HARM TO HEALTH.
>>SO AGAIN, THERE ARE SOME
EXCEPTIONS IN CLIA FOR RETURN
AND HOW YOU CAN ACTUALLY CONDUCT
SURVEILLANCE.
BUT I THINK THE BROADER RUBRIC
THAT'S GOING TO COME INTO PLAY
IS IS IT INDIVIDUAL LEVEL DATA
RESULT BEING RETURNED TO THE
INDIVIDUAL THAT IT'S ACTUALLY
DERIVED FROM, AND WHETHER
IT'S -- IF YOU'RE TALKING ABOUT
JUST BIOMONITORRING SAMPLES,
WHETHER YOU'RE LOOKING AT
WASTEWATER, FOR INSTANCE, YOU
KNOW, TO BRING IT ABOARD INTO
ENVIRONMENTAL HEALTH, UNLESS
YOU'RE SOMEHOW ACTUALLY
RETURNING AN INDIVIDUAL'S
RESULTS TO THE INDIVIDUAL
DERIVED FROM, IT'S NOT GOING TO
BE UNDER CLIA.
SO I THINK THE QUESTION REALLY
DERIVES BACK ON TO THE
INFORMATION YOU'RE PROVIDING AND
TO WHOM.
>>IF I COULD JUST ADD OUT TO
THAT, ADAM, I THINK THIS
QUESTION IS ABOUT INDIVIDUAL
BIOSAMPLES.
SO IT'S ABOUT SOMEBODY WHO
PROVIDES A URINE SAMPLE, YOU GET
A RESULT, THERE'S SOME RESEARCH
THAT THAT RESULT IS RELATED TO
AN OUTCOME EPIDEMIOLOGICALLY,
BUT IT DOESN'T -- THERE'S NO
IMPLICATION FOR A DIAGNOSIS OR
TREATMENT OF A DISEASE.
SO WHERE DOES CLIA COME INTO
EFFECT THERE?
>>SO I'LL GO BACK, CLIA DOESN'T
ACTUALLY TAKE INTO ACCOUNT WHAT
THE APPLICABILITY IS.
IT ASKS WHAT THE PURPOSE OF THE
TESTING AND HOW THAT COULD BE
USED.
SO IF IT COULD BE USED FOR
EVENTUAL TREATMENT, AND THAT
COULD BE TODAY, IT COULD BE 20
YEARS FROM NOW, BECAUSE THIS IS
THE WAY THAT CLIA OR CMS HAS
TENDED TO INTERPRET THIS, IF IT
COULD BE USED AT ANY POINT IN
TIME TO MANAGE AN INDIVIDUAL'S
HEALTH AND THE CARE THEY
RECEIVE, IT FALLS UNDER CLIA.
>>CAN I JUST ASK ANOTHER -- AN
ADDITIONAL QUESTION ABOUT THAT.
SO I THINK IT APPLIES TO HIPAA
AS WELL AS CLIA.
SO WHAT IF THE PEOPLE THAT WE
ARE -- THAT WE HAVE AS
PARTICIPANTS IN OUR STUDIES ARE
NOT PATIENTS?
SO WE'RE DOING EPIDEMIOLOGY.
AND WITHIN ECHO, THERE MIGHT BE
SOME COVERED ENTITIES, THERE
MOIT MIGHT NOT BE, BUT LET'S SAY
THEY'RE NOT, THEY'RE NOT COVERED
ENTITIES AND THEY'RE NOT
PATIENTS, THEY'RE JUST COMMUNITY
MEMBERS.
HOW DO REGULATIONS APPLY THERE?
>>SO CLIA AGAIN APPLIES JUST
WHEN YOU'RE TALKING ABOUT RETURN
OF INDIVIDUAL RESULTS TO AN
INDIVIDUAL.
IF YOU'RE TALKING ABOUT
COLLECTING COMMUNITY LEVEL DATA
THAT ISN'T GENERALLY GOING TO
FALL WITHIN THE SCOPE OF WHAT
THEY'RE LOOKING AT.
SO IT'S ALWAYS GOING TO COME
BACK TO IF YOU'RE TESTING AN
INDIVIDUAL AND THE PURPOSE FOR
WHICH YOU'RE ACTUALLY TESTING
AND HOW THAT INFORMATION COULD
BE USED NOW OR SOMETIME IN THE
FUTURE.
IS SORT OF THE RUBRIC I TEND TO
APPLY IN MOST OF THESE
SITUATIONS.
BUT COMMUNITY LEVEL DATA, YOU
KNOW, IF YOU'RE LOOKING AT
WHAT'S THE AIR QUALITY IN THIS
ZIP CODE, WHICH IS 20817 -- I
MEAN, BUT AGAIN, IT'S ALL BASED
ON INDIVIDUAL LEVEL INFORMATION,
BUT IT ALSO WOULD DEPEND ON WHAT
IS THE DATA YOU'RE TALKING
ABOUT, DID IT DERIVE FROM HUMAN
SPECIMEN, THEN IT'S GOING TO
ACTUALLY -- YOU KNOW, CLIA COULD
POTENTIALLY APPLY IN THAT CASE.
HIPAA FROM A STANDARD OF
COMMUNITY LEVEL, HIPAA APPLIES
TO COVERED ENTITIES, IT'S GOING
TO ALLOW ACCESS TO YOUR
DESIGNATED RECORD SET.
IF THE INFORMATION YOU'RE
TALKING ABOUT HAS BEEN ENTERED
INTO THE ELECTRONIC HEALTH
RECORD.
THERE ARE SOME EXCEPTIONS FOR
EVEN EHRs BEING APPLICABLE
HERE, BUT IF IT'S ALREADY IN THE
ELECTRONIC HEALTH RECORD, YOUR
CLINICIAN ENTERED IT OR THE
RESEARCHER ENTERED IT AND WASN'T
A RESEARCH PARTITION OF YOUR EHR
SYSTEM, THAT'S GOING TO BE
ACCESSIBLE UNDER HIPAA.
>>JOHNNYE.
>>SO I GUESS I'M HAVING A
REALLY HARD TIME WITH THE
CONCEPT OF A SPOT URINE
BIOMONITORRING RESULT OF AN
EMERGING CHEMICAL AT SOME POINT
IN THE FUTURE POSSIBLY BEING
USED FOR DIAGNOSTICS OR
TREATMENT.
WHEN WE HAVE EMERGING CHEMICALS
THAT WE'RE TELLING PEOPLE IN THE
NEWS ALL THE TIME ARE NOT GOING
TO BE GOOD FOR THEIR HEALTH.
THEY'RE NOT NATURALLY OCCURRING,
THERE'S SOMETHING THAT'S
INTRODUCED FROM OUTSIDE, AND
THOSE SPOT URINE, IF ANYTHING,
WOULD JUST BE SAYING, IF WE LOOK
AT 100 PEOPLE, HERE'S WHERE YOU
FALL ON THAT THING THAT WE DON'T
KNOW WHAT IT DOES YET.
IT SEEMS TO ME WHAT YOU'RE DOING
DEFINITELY FALLS UNDER
BENEFICENCE AT THAT POINT
BECAUSE YOU'RE SHOWING PEOPLE
HOW THEY MIGHT GET AHEAD OF
THIS.
YOU'RE TRYING TO SHOW THEM THAT
WE DON'T KNOW WHAT IT MEANS BUT
IT IS A POSSIBLE RISK.
AND IT'S UP TO THEM TO MAKE A
DECISION ON IF THEY WANT TO KEEP
GOING DOWN THAT PATH OR CHANGE
THAT.
AND YOU WOULD HAVE TO LOOK AT
ANY OF THE BIOMONITORRING
RESULTS IN A SIMILAR PERSPECTIVE
BECAUSE AS WE START COMING UP
WITH WAYS TO LOOK AT HOW
INTERACTIONS OCCUR, BECAUSE WE
HAVE ENOUGH SAMPLES IN SOMETHING
LIKE ECHO TO START DOING THAT,
WE FIND OUT THAT WHAT WE THOUGHT
WAS TOXIC BEFORE MAYBE ISN'T
TOXIC IF YOU HAVE THESE OTHER
THREE METALS WITH IT.
SO IT'S AN EVOLVING SCIENCE, AND
IT KIND OF GETS BACK TO WHAT WE
WERE TALKING ABOUT BEFORE, THAT
IF AS SCIENTISTS WE WOULDN'T
HAVE PUT OURSELVES IN THIS TIGHT
LITTLE BOX THAT ASSUMES THAT
NOBODY CAN UNDERSTAND
UNCERTAINTY, WE WOULD BE IN A
MUCH BETTER PLACE.
SO IS THERE SOMEPLACE THAT YOU
CAN GET A DEFINITION OF WHAT
THIS POSSIBLE USE IN THE FUTURE
FOR DIAGNOSTICS WOULD BE?
BECAUSE IT REALLY LIMITS
PEOPLE'S RIGHTS, I THINK, TO
INFORMATION.
>>SO I'LL SAY, I THINK THIS IS
A PERFECT QUESTION TO ACTUALLY
POSE TO CMS AND I'M GOING TO
LOOK AT MATT AND THE ECHO
PROGRAM, THESE ARE QUESTIONS
THAT CAN BE RAISED TO CMS TO
ACTUALLY CLARIFY, YOU KNOW, THE
NOW OR SOMETIME IN THE FUTURE
HAS JUST BEEN THEIR
LONG-STANDING INTERPRETATION,
YOU KNOW, IT'S POSSIBLE THAT IF
YOU PRESENT THEM WITH THE
BIOMONITORRING EXAMPLE THAT YOU
JUST POSED, THEY MAY LOOK AT
THAT DIFFERENTLY BUT THAT'S FOR
CMS TO MAKE A JUDGMENT CALL ON.
I CAN JUST TELL YOU WHAT I'M
WEAR OF AS THEIR LONG-STANDING
INTERPRETATION, IT'S FLOT THAT
IT HAS TO BE USABLE TODAY, IT'S
THAT IT COULD BE POTENTIALLY
INFORMATIVE AT ANY POINT IN TIME
IN THE FUTURE.
HOW THAT APPLIES SPECIFICALLY TO
THIS -- TO THE CASE YOU'RE
LAYING OUT, I THINK YOU WOULD
HAVE TO GO TO CMS TO GET THAT
CLARITY.
>>AND I'D JUST PROPOSE A
SOLUTION THAT DOESN'T EVEN
REQUIRE CLARIFYING ALL OF THIS,
WHICH WOULD BE EITHER DEVELOP A
RESOURCE CENTRALLY CAPABLE OF
REPRODUCING SOME THINGS WITHIN A
CLIA ENVIRONMENT, SO SORT OF
DEVELOP A CLIA INFORMATION
PROCESS, AND THAT SEEMED
IMPOSSIBLE 10 YEARS AGO IN
GENETICS AND GENOMICS AND FOLKS
WERE SORT OF LIKE WELL IF WE
HAVE TO DO THAT, IT'S NEVER
GOING TO HAPPEN, BUT THEN WITHIN
SEVERAL YEARS IT ACTUALLY WAS
HAPPENING AND THAT CREATED WHOLE
NEW OPPORTUNITIES TO DO THINGS,
TO DO INTERVENTIONAL RESEARCH,
WHAT WE CALL NOW GENOMIC
MEDICINE BUT WE CAN HAVE
ENVIRONMENTAL PUBLIC HEALTH,
RIGHT, WHERE WE'RE ACTUALLY NOW
USING THE RESOURCES WE CREATED
TO GENERATE THIS INFORMATION FOR
POPULATION HEALTH THAT CREATES
AN OPPORTUNITY.
SO YOU CAN EITHER DO THAT
CENTRALLY AND SORT OF HAVE A
CONFIRMATION METHOD OR THOSE
INDIVIDUAL LABS CAN ACTUALLY GO
THROUGH THE PROCESS OF BUILDING
THE CASE THAT WE HAVE MET THE
REQUIREMENTS OF CLIA AND IT'S
NOT -- IT'S COMPLEX BUT IT'S
NOT, YOU KNOW, MAGIC, THERE'S
SORT OF LIKE HANDLING OF SAMPLES
TO MAKE SURE WE KNOW THIS SAMPLE
CAME FROM THIS PERSON.
SO IT IS DOABLE, I'M NOT AN
EXPERT IN THIS AREA BUT THERE
ARE CERTAINLY GROUPS THAT TOOK
THE PLUNGE AND SAID LET'S DO IT.
AND THAT'S OPENED UP REALLY
GREAT OPPORTUNITIES AFTERWARDS.
>>I THINK YOUR QUESTION RAISES
THE HARDEST SET OF QUESTIONS FOR
THIS WHOLE STUDY AND CONFERENCE
AND WHEN YOU'RE LOOKING AT
CHEMICAL EXPOSURES, LET'S SAY,
AND YOU HAVE NO IDEA WHAT THAT
MEANS.
YOU THINK THEORETICALLY THERE
MAY BE A PROBLEM THERE, I THINK
IT'S VERY PROBLEMATIC
COMMUNICATION WITH A MOTHER TO
SAY YOUR FETUS HAS BEEN EXPOSED
TO THIS THING AND WE DON'T HAVE
ANY IDEA WHAT THAT MEANS.
MAYBE WE'LL FIND OUT IN FIVE OR
10 YEARS.
THAT'S A PRETTY PROBLEMATIC
MESSAGE.
I WOULDN'T SPEAK PERSONALLY IN
TERMS OF PEOPLE'S RIGHTS TO
INFORMATION, I THINK IT'S THEM
GETTING -- RISE TO THAT LEVEL
FOR RESEARCH INFORMATION BUT I
THINK YOU HAVE TO DEAL WITH IT
ON A CASE-BY-CASE BASIS.
IF YOU HAVE VERY GOOD REASON TO
BELIEVE THERE'S TOXICITY AND
YOUR RESEARCH IS TO FIND WHAT
THE THRESHOLD VALUE IS OF
TOXICITY THEN IT SEEMS TO ME YOU
HAVE A MUCH STRONGER RATIONALE
FOR COMMUNICATING INDIVIDUAL
RESULTS.
BUT IN THOSE CONTEXTS, YOU'RE
JUST LOOKING AND YOU'RE
MEASURING A WHOLE BUNCH OF STUFF
AND YOU DON'T KNOW WHAT THAT
MEANS AND YOU'LL FIGURE IT OUT
LATER, I THINK THAT'S THE
HARDEST CASE TO TALK ABOUT
COMMUNICATING RESULTS IN A
MEANINGFUL WAY.
IT'S ALSO AN OPPORTUNITY TO SAY
IF YOU'RE GOING TO BE DOING THAT
IN TERMS OF PREPARING THOSE
KINDS OF RESULTS, THAT'S WHERE
THE OBLIGATION IS STRONGEST TO
DO A SUBSTUDY TO SAY ALL RIGHT,
HOW ARE PEOPLE DEALING WITH THIS
INFORMATION?
AND IF YOU'RE FREAKING A LOT OF
PEOPLE OUT AND THEY CAN'T DO
ANYTHING WITH THE INFORMATION,
THEN YOU NEED TO KNOW THAT.
>>FROM WHAT YOU WERE SAYING, IT
REMINDS ME OF THE EARLY DAYS OF
GENOMIC SEQUENCING WHERE THE
DEBATES WERE DO WE RETURN EVERY
STEP WE IDENTIFY OR DO WE NARROW
IT DOWN TO THINGS THAT WE KNOW
ABOUT, WHAT DO WE DO WITH THE
THINGS WE DON'T KNOW ANYTHING
ABOUT.
I THINK THE FIELD HAS COALESCED
AROUND RETURNING THOSE WE KNOW
ARE CLINICALLY ACTIONABLE AT
THIS POINT.
I THINK MANY WOULD STILL ARGUE
THAT EVEN THAT IS MATERNALISTIC
BECAUSE PEOPLE HAVE DIFFERING
VALUE SYSTEMS IN TERMS OF
PERSONAL UTILITY OF INFORMATION
EVEN IF IT'S NOT ACTIONABLE OR
IF IT'S JUST OTHER INFORMATION
THAT THEY'D LIKE TO HAVE ACCESS
TO.
I KNOW A LOT OF PEOPLE OUT THERE
THAT JUST WANT LITERALLY
EVERYTHING.
THEY WANT THE ENTIRE FILE, JUST
HAND THAT OVER.
BUT I THINK THERE MAY BE SOME
LESSONS THAT COULD BE LEARNED
FROM THE GENETICS AND GENOMICS
SPACE THAT COULD BE APPLICABLE
AS WELL AS YOU'RE THINKING
THROUGH THE EARLY DAYS OF WHAT
DOES A CHEMICAL EXPOSURE MEAN
TODAY AND HOW DO YOU HANDLE THAT
VERSUS SOMETHING A LITTLE BIT
MORE DEFINITIVE FIVE YEARS FROM
NOW.
>>MONICA, DID YOU HAVE A
QUESTION?
>>I DIDN'T HAVE A QUESTION PER
SE BUT I DO WANT TO JUST
ACKNOWLEDGE AND TO CAUTION US TO
REDUCE OUR OPERATION ON
TECHNICAL ELITISM, I DO FEEL
THAT SOME OF THE WAYS THAT THE
THOUGHT EXPERIMENTS ARE BEING
PLAYED OUT AND TALKED ABOUT ARE
ASSUMING AN INFORMATION DEFICIT
MODEL WITH THE RECIPIENT, WITH
THE PARTICIPANT, WITH THE
COLLABORATOR, WITH THE COMMUNITY
MEMBER.
AND I WOULD ACKNOWLEDGE THAT
THESE ARE MASSIVE OPPORTUNITIES
FOR LEARNING, AND FOR INFORMAL
SCIENCE EDUCATION.
AND SO -- AND ALSO -- SO I JUST
WANT TO ACKNOWLEDGE THAT YOU
CAN'T -- I KNOW WE DO THOUGHT
EXPERIMENTS, AND I KNOW THERE'S
ETHICISTS UP THERE WHO DO, I
MEAN, THAT'S WHAT A WHOLE CLASS
WOULD BE AND I THINK THAT'S SUCH
A GREAT TERM, RIGHT, THOUGHT
EXPERIMENT.
BUT THE IDEA HERE IS THAT LIKE
THIS OH, LIKE WE WOULD HAVE TO
TAKE AWAY RESOURCES FROM THE
RESEARCH AND IT'S LIKE, YEAH,
YOU TAKE AWAY RESEARCH,
RESEARCH, LIKE, YOU TAKE AWAY
SOME OF THOSE RESOURCES FOR
REPORT-BACK FROM THE RESEARCH
BECAUSE THE REPORT-BACK CAN LEAD
TO CHANGES THAT YOU CAN'T EVEN
IMAGINE RIGHT NOW BECAUSE OF THE
POWER OF INFORMAL SCIENCE
LEARNING, LIKE FREE CHOICE
LEARNING, WHAT PEOPLE DO WITH
THIS INFORMATION, AND SO I JUST
WANT TO -- I GUESS I'VE GOT A
LITTLE -- AND THE TYPES OF
INTERPRETATION AND KNOWLEDGE
CHANGES AND KNOWLEDGE GAPS THAT
THEY MIGHT BE ABLE TO FILL, AND
SO I GET A LITTLE BIT NERVOUS
WHEN THESE, LIKE, CONVERSATIONS
START TO HAPPEN WHERE I START TO
FEEL LIKE, THAT THERE'S AN
OPERATION UNDER COMPLETE DEFICIT
OF THE PARTICIPANT OR THE
RECIPIENT WHEN THEY ARE THIS
WEALTH OF KNOWLEDGE AND THEY'RE
NOT, QUOTE-UNQUOTE, JUST A
VESSEL THAT YOU'RE GOING TO FILL
UP WITH INFORMATION, THAT THEY
CONTAIN TONS OF INFORMATION,
TONS OF EXPERTISE AND KNOWLEDGE,
THAT NEEDS TO BE CONTEXTUALIZED
WITH -- LIKE WE NEED -- THESE
DATASETS NEED TO BE
CONTEXTUALIZED WITHIN THEIR
KNOWLEDGE BASES.
SO I'M JUST MAKING THAT -- I
MEAN, I UNDERSTAND THIS FIRST
SECTION WAS HISTORY AND
PRINCIPLES SO I STAYED QUIET
THROUGHOUT IT ALL TO UNDERSTAND
THAT THIS IS BACKGROUND SETUP
BUT I DO WANT TO ACKNOWLEDGE
THAT THESE INDIVIDUALS RECEIVING
THESE ARE NOT PASSIVE, AND
THEY'RE NOT VESSELS TO JUST BE
FILLED.
>>THANKS, MONICA.
I ALSO WANTED TO JUST ADD THAT
MANY OF THE HYPOTHETICALS THAT
ARE BEING RAISED ARE SITUATIONS
WHERE WE HAVE REAL WORLD
EXPERIENCE THAT PARALLELS THOSE
HYPOTHETICALS, AND I JUST WANTED
TO LIFT UP ONE EXAMPLE, THE
UNIVERSITY OF CINCINNATI PUBERTY
COHORT IN THE BREAST CANCER
ENVIRONMENT RESEARCH PROGRAM
INADVERTENTLY DISCOVERED HIGH
LEVELS OF PFAS IN SOME OF THE
GIRLS.
AT THE TIME, WE DIDN'T KNOW
WHERE IT WAS COMING FROM, WE
DIDN'T KNOW THE HEALTH
IMPLICATIONS, AND THERE WAS
DEBATE ABOUT REPORTING RESULTS
BACK.
THEY WERE REPORTED BACK, SUSAN
PINNEY LED THAT WORK.
THEY DID INTERVIEW THEIR
PARTICIPANTS AFTERWARDS.
THE FIRST AUTHOR OF THE PAPER IN
ENVIRONMENTAL HEALTH
PERSPECTIVES IS ANNE HERNICK,
AND THEY DID FIND THAT THEIR
PARTICIPANTS SAID, OUT LOUD, I
UNDERSTAND YOU DON'T KNOW WHERE
THIS IS COMING FROM, I
UNDERSTAND THAT YOU DON'T KNOW
THE HEALTH EFFECTS.
THANK YOU FOR TELLING US ABOUT
THIS.
AND YOU CAN SEE AS HISTORY HAS
PLAYED OUT THAT THAT INFORMATION
HAD POTENTIAL ACTION VALUE
BECAUSE IT WAS CLEAR THAT THERE
WAS SOME GEOGRAPHICALLY-BASED
EXPOSURE IN THIS COMMUNITY THAT
DID NEED TO BE IDENTIFIED, OR
PURSUED IN SOME WAY, AND THAT
THESE EXPOSURES WE NOW KNOW MAY
HAVE HEALTH IMPLICATIONS.
>>I JUST WANTED TO EMPHASIZE ON
WHAT MONICA SAID.
IT REALLY GOT ME EMOTIONAL.
BECAUSE I DEALT WITH SO MANY
HEALTH ISSUES THROUGHOUT ALL OF
MY PREGNANCIES.
I'VE HAD FIVE MISCARRIAGES, AND
IT WOULD BE NICE AS A
PARTICIPANT TO GET OUR REPORT
BACKS.
BECAUSE THEN THAT WAY, IT PUTS
ME IN A POSITION TO BETTER
UNDERSTAND WHAT MY EXPOSURES
ARE, WHAT MY TOXICITIES ARE, AND
HOW I CAN CHANGE THAT IN MY
FAMILY, WILL THIS AIIVET MY
DAUGHTER, WHO IS A PARTICIPANT,
WHO HAS DEVELOPMENTAL DELAYS AND
WHO HAS DISABILITIES, WHO WAS
BORN PREMATURE, ALL FOUR OF MY
CHILDREN, LIVING CHILDREN, WERE
BORN PREMATURE, AND THAT'S JUST
SOMETHING THAT I WOULD LIKE TO
KNOW AS A PARTICIPANT.
IT'S SOMETHING THAT I WOULD LIKE
TO EDUCATE MY COMMUNITY ABOUT
BEING A WOMAN'S HEALTHCARE
NURSE, I WOULD LIKE TO EDUCATE
MY PATIENTS ABOUT THAT.
I WOULD LIKE TO TEACH THE
YOUNGER GENERATIONS ABOUT THAT.
BECAUSE OF ECHO AND BECAUSE OF
ME BEING A PARTICIPANT AND
EDUCATING MY DAUGHTER WHO IS A
NEW MOTHER TO A 1-YEAR-OLD CHILD
WHO HAS AUTISM.
WE NEVER HAD AUTISM IN MY
FAMILY.
MY DAUGHTER IS ACUTE AUTISTIC.
AND SINCE THOSE THINGS HAD AROSE
IN OUR FAMILY, SHE WENT TO --
SHE IS COMPLETING HER NURSING
AND RESEARCH NURSING.
SHE'S A BIOCHEMIST MAJOR IN
BIOLOGY, CHEMISTRY, AND SO WE
HAVE ALL OF THESE QUESTIONS AND
SHE WORKS WITH THE JOHN HOPKINS
PROGRAM AND THEY'RE ABLE TO GET
THEIR RESULTS BACK.
THEY'RE ABLE TO TELL THEIR
PARTICIPANTS, YOU KNOW, HOW --
WELL, THEIR STUDY IS ON, YOU
KNOW, COVID AND THE
IMMUNIZATIONS IN OUR POPULATION
IN COMPARISON TO POPULATIONS ALL
OVER THE UNITED STATES, THAT
PUTS OUR GENERAL CULTURAL -- OUR
GENERAL -- THE NAVAJO NATION IN
A CERTAIN POPULATION AND A
CRITERIA TO WHERE WE CAN
UNDERSTAND HOW OUR HEALTH
DISABILITIES, LIKE DIABETES,
OBESITY AND WHATNOT PERTAINS TO
THE DIFFERENT EFFECTS OF COVID.
THOSE ARE THINGS -- AND THE SAME
GOES FOR ME BEING IN A WOMAN'S
HEALTH PRACTICE, YOU KNOW, I
KNOW YOU GUYS ARE NOT CDC, BUT
CDC CAN GET BACK TO US ON LIKE
OUR PAP SMEARS.
THEY CHANTHEY CHANGE THOSE GUIDS
LIKE EVERY 6 MONTHS ON HOW OFTEN
WE SHOULD BE DOING PAP SMEARS
BASED ON WHAT KINDS OF
ABNORMALITIES COME BACK FOR OUR
PATIENTS.
THERE'S GOT TO BE A WAY WE CAN
GET THESE REPORT-BACKS SOONER
THAN -- IT'S BEEN THREE YEARS
SINCE I'VE -- YOU KNOW, MY
DAUGHTER IS GOING TO BE 4 YEARS
OLD, SHE'S COMING UP ON HER
4-YEAR EVALUATION, AND I'M
THANKFUL FOR THE -- YOU KNOW,
THE REFERRALS THAT THE PROGRAM
HAS, BUT THEN THAT STILL DOESN'T
ANSWER MY QUESTION ON IS IT
BECAUSE OF SOMETHING I DID, IS
IT BECAUSE OF SOMETHING THAT I
HAD GENETICALLY OR IS IT BECAUSE
OF SOMETHING THAT WE WERE
EXPOSED TO?
>>THANK YOU FOR SHARING THAT.
I THINK IN THE INTEREST OF TIME,
WE'RE GOING TO CLOSE.
I NOI KNOW WE'RE BEHIND FOR THIS
SESSION.
SO I JUST WANTED TO THANK AGAIN
ALL THE SPEAKERS AND THE
DISCUSSANT AND I THINK THIS WAS
REALLY USEFUL TO KICK START THE
WORKSHOP.
>>THANKS, EVERYONE.
WE'RE ONLY A HALF-HOUR BEHIND.
SO HOW ABOUT WE BEGIN AGAIN AT
11:55, AND BECAUSE WE HAVE SOME
TIME AT THE END OF THE DAY,
RIGHT, CLAY, WE COULD STILL HAVE
A REASONABLE LUNCH HOUR EVEN IF
WE HAVE A FULL SESSION 2?
>>GOOD AFTERNOON, EVERYONE.
MY NAME IS SUNDANIA WONNUM.
I'M EXCITED TO PRESENT THE NEXT
SESSION WHICH IS ON THE VALUE OF
INDIVIDUAL RESULTS TO
PARTICIPANTS FROM THEIR OWN
PERSPECTIVE.
CHAIRING THIS SESSION IS
DR. JOHNNYE LEWIS, WHO IS THE
PROFESSOR -- A PROFESSOR OF
COLLEGE OF PHARMACY AT THE
UNIVERSITY OF NEW MEXICO, WHERE
HER FOCUS IS ON ADDRESSING MAJOR
ENVIRONMENTAL HEALTH DISPARITIES
THAT ADVERSELY IMPACT INDIGENOUS
PEOPLES FROM ACROSS THE U.S.,
PARTICULARLY COMMUNITY MEMBERS
AND TRIBAL LEADERSHIP.
AND THERE SHE DIRECTS THE
COMMUNITY -- THE UNIVERSITY OF
MEXICO COMMUNITY ENVIRONMENTAL
HEALTH PROGRAM THREE CENTER
GRANTS.
BEFORE THAT, WE WILL HAVE TWO
SPEAKERS.
WE WILL HAVE JYOTI ANGAL FROM
AVERA RESEARCH INSTITUTE, AS
WELL AS JULIE HERBSTMAN FROM THE
COLUMBIA UNIVERSITY.
>>GOOD AFTERNOON, EVERYONE.
CAN YOU ALL HEAR ME OKAY?
I'M GLAD EVERYBODY CAN SEE ME.
,
TOO, WITH THE HEIGHT OF THE
PODIUM.
SO I'M REALLY EXCITED TO BE
HERE, AND BE A PART OF THIS
DISCUSSION.
I THINK WE'VE HAD AN EXCITING
FIRST SESSION WHERE YOU HEARD
SEVERAL DIFFERENT OPINIONS, BUT
SORT OF THE MAIN THEME WAS WE
NEED TO HEAR FROM PARTICIPANTS,
WE NEED TO KNOW WHAT THEY WANT.
IN ORDER TO DO A BETTER JOB OF
ALIGNING OUR RESOURCES IN
RETURNING RESULTS.
SO WITH THAT IN MIND, I'M GOING
TO SHARE SOME OF MY RECENT
DISSERTATION WORK ON THIS TOPIC,
AND I HAD THE PRIVILEGE OF
WORKING WITH OUR ECHO
PARTICIPANTS.
I REPRESENT THE SOUTH DAKOTA
ECHO COHORT, AND IN RESPONSE TO
THE GROWING CALL OF WE NEED TO
ASK THEM, THAT'S WHAT I DID, I
ASKED THEM WHAT THEY WANTED AND
HOW THEY WANTED.
SO WE TALKED ABOUT THIS EARLIER,
BUT JUST A QUICK REVIEW OF WHAT
DO WE KNOW ABOUT PARTICIPANT
PERSPECTIVE SO FAR.
SO WE KNOW THAT THEY'RE
ENTHUSIASTIC ABOUT RECEIVING
RESULTS.
WE KNOW THAT PARTICIPANT
OPINIONS DIFFER.
IF YOU ASK FOUR DIFFERENT
PEOPLE, YOU MIGHT GET DIFFERENT
RESPONSES.
OPINIONS AND PREFERENCES DIFFER,
AND WE ALSO KNOW THE RETURN OF
RESULTS IS ASSOCIATED WITH
INCREASED MOTIVATION TO
PARTICIPATE, AND IS SEEN AS AN
ACT OF RECIPROCITY.
WHAT DO WE NEED TO FIND OUT?
WE NEED TO FOCUS NOW ON RETURN
OF RESULTS BEYOND GENETIC
RESULTS.
AND WE'VE TALKED ABOUT THIS TOO,
LOOKING AT RESULTS THAT
TYPICALLY COME FROM COHORT
STUDIES LIKE ECHO.
PHYSICAL MEASURES, SELF-REPORTED
DATA, VARIABLE DATA.
WE NEED TO FOCUS ON RESULTS OF
NON-CLINICAL SIGNIFICANCE.
BECAUSE THAT'S TYPICALLY
RETURNED IN A NORMAL SETTING,
AND HOW DO WE DO A BETTER JOB OF
RETURNING RESULTS TO PREGNANT
PEOPLE AND CHILDREN.
SO AS MATT ALLUDED EARLIER, ECHO
COLLECTS A WEALTH OF DATA
LOOKING AT AN INDIVIDUAL GOING
FROM SOCIETY TO BIOLOGY, AND SO
WITH THAT IN MIND, THE ECHO TASK
FORCE ON RETURN OF RESULTS WAS
CHARGED WITH CREATING A POLICY
TO HELP RETURN THESE RESULTS.
OUR APPROACH LIKE MANY SORT OF
POLICY APPROACHES WAS SORT OF
RESEARCHER-DRIVEN WITH FOCUS ON
RESULTS THAT WERE CLINICALLY
SIGNIFICANT, AS WELL AS THOSE
THAT HAD RESULTS WITH
ESTABLISHED NORMATIVE STANDARDS.
GIVEN THE DIVERSITY IN THE ECHO
COHORT, IT SEEMED APPROPRIATE AT
THAT TIME TO PUT TOGETHER
POLICIES THAT FOCUSED ON RESULTS
THAT HAD ESTABLISHED VALID
STANDARDS.
AND ONE OF THE REASONS, AND I
REMEMBER RACHEL TO THIS DAY
SAYING THAT I WISH WE COULD ASK,
I WISH WE COULD ASK THEM WHAT
THEY WANTED THAT WOULD HELP US
CREATE A BETTER POLICY, WAS THAT
WE DID NOT HAVE PARTICIPANT
PERSPECTIVES FROM OUR COHORT.
SO WITH THAT IN MIND, I HAVE
THREE QUESTIONS THAT I ASK OF
PARTICIPANTS.
SO TO WHAT EXTENT DOES RESULT
TYPE, WHEN YOU LOOK AT DIFFERENT
RESULTS DATA THAT GENERATES
RESULTS IN ECHO.
TO WHAT EXTENT DOES RESULT TYPE
AND STANDARDIZATION STATUS,
WHICH IS WHETHER OR NOT THESE
RESULTS CAN BE PLACED IN
NORMATIVE CONTEXT, DOES IT
INFLUENCE PARTICIPANT
PERCEPTIONS OF VALUE OF
RECEIVING RESULTS?
ARE THERE RACIAL DIFFERENCES
BETWEEN WHITE AND AMERICAN
INDIAN PARTICIPANTS IN THE
ASSOCIATION OF RESULT TYPE?
I CHOSE AMERICAN INDIAN GIVEN
THAT THAT'S THE LARGEST MINORITY
IN OUR STATE IN SOUTH DAKOTA.
AND THEN THE THIRD QUESTION I
WANTED TO EXPLORE WAS HOW DO
PARTICIPANTS DECIDE PERSONAL
VALUE OF INDIVIDUAL RESULTS?
SO THERE WAS A MIXED METHODS
DESIGN AND IN THE FIRST PART, WE
COMPARED THE RESULT TYPE WHICH
HAD THREE LEVELS, LOOKING AT
SURVEY RESULTS, BIOSPECIMEN
RESULTS AND PHYSIOLOGY RESULTS
AND LOOKING AT TWO LEVELS OF
STANDARDIZATION, WHETHER OR NOT
THESE RESULTS COULD BE EXPLAINED
IN NORMATIVE CONTEXT.
EACH PARTICIPANT WAS PRESENTED
ONE OF SIX SCENARIOS, RANDOMIZE
DOLLARS INTO TWO DIFFERENT
GROUPS BASED ON THE DESIGN.
SO THIS IS AN EXAMPLE OF A
SCENARIO THAT A PARTICIPANT WAS
PRESENTED REGARDING A CHEMICAL
EXPOSURE RESULTS, AND IT GOES TO
WHAT JOHNNYE HAD BROUGHT UP
EARLIER IS THAT IN THIS
SCENARIO, THE PARTICIPANT WAS
TOLD THAT THE URINE SAMPLE HAD
TESTED POSITIVE FOR A CERTAIN
KIND OF PHTHALATE, AND THEN SHE
WAS ALSO TOLD WHETHER OR NOT HER
RESULTS WOULD BE CONSIDERED
ACCEPTABLE OR NOT ACCEPTABLE.
SO MEANING THAT SHE WAS TOLD
THAT WHETHER OR NOT THEY COULD
BE COMPARED TO OTHER WOMEN OF
HER AGE GROUP.
SO WHAT DID WE FIND WHEN WE
ADMINISTERED THESE SCENARIOS TO
PARTICIPANTS?
WE HAD A TOTAL OF 2700,
APPROXIMATELY, PARTICIPANTS THAT
WERE ELIGIBLE AND RECEIVED A
SURVEY, WITH THE FINAL DATASET
OF ABOUT 1587 PARTICIPANTS THAT
RESPONDED TO THESE SCENARIO
QUESTIONS.
I WANTED TO COMPARE -- THIS IS A
BUSY TABLE, SO DON'T FOCUS ON
THE NUMBERS, I'LL TALK YOU
THROUGH IT.
I WANTED TO COMPARE IF
PARTICIPANTS IN EACH OF THESE
SIX GROUPS WERE DIFFERENT OR
SAME WITH EACH OTHER, AND
LOOKING AT ACROSS MATERNAL AGE,
RACE, EDUCATION, WE DID NOT FIND
ANY DIFFERENCES BETWEEN EACH OF
THE SIX GROUPS MAKING US FEEL
FAIRLY GOOD ABOUT HOW THE
RANDOMIZATION WORKED IN THESE
GROUPS.
SO FOR THE FIRST QUESTION, TO
WHAT EXTENT DO RESULT TYPE AND
STANDARDIZATION INFLUENCE
PARTICIPANT PERSPECTIVES?
WE FOUND NO INTERACTION BETWEEN
RESULT TYPE AND STANDARDIZATION
STATUS.
BUT THE MAIN EFFECTS WERE
SIGNIFICANT.
WE FOUND STANDARDIZED RESULTS,
SO AGAIN, RESULTS THAT COULD BE
EXPLAINED WITHIN A NORMATIVE
CONTEXT, WERE ATTRIBUTED A
HIGHER VALUE THAN
NON-STANDARDIZED RESULTS.
AND THEN THE RESULT TYPE WAS
STRONGLY ASSOCIATED WITH
PERCEIVED VALUE OF INDIVIDUAL
RESULTS WHERE BIOSPECIMEN
RESULTS HAD A HIGHER PERCEIVED
VALUE THAN SURVEY RESULTS OR
PHYSIOLOGY RESULTS.
THIS GEOPLOT SORT OF DESCRIBES
THE RESULTS I JUST TALKED ABOUT.
IF YOU LOOK ACROSS THE FIGURE,
THE BLUE GROUP IS THOSE THAT
RECEIVED THE STANDARDIZED
SCENARIO, AND THEN THE ORANGE
ONE RECEIVED THE UNSTANDARDIZED
SCENARIO.
AND IF YOU LOOK AT IT, THE MEAN
IS THE BOLD BLACK LINE, SO THE
MEANS IN THOSE GROUPS WERE
CONSISTENTLY HIGHER FOR THE
STANDARDIZED THAN THE
UNSTANDARDIZED GROUPS.
SO FOR THE THIRD QUESTION ON HOW
TO PARTICIPANTS -- HOW DO THEY
PERCEIVE THE VALUE AND HOW DO
THEY MAKE DECISIONS ABOUT THE
VALUE, WE DID A QUALITATIVE
APPROACH.
AND INTERVIEWED A SUBGROUP OF
PARTICIPANTS WHO HAD
<<A>>
ED THE SURVEY QUESTIONS.
WE HAD 10 PARTICIPANTS FROM THAT
GROUP.
THEY WERE RANDOMLY SELECTED FROM
THOSE ELIGIBLE FOR THE
QUANTITATIVE STUDY AND
STRATIFIED BY RACE AND MATERNAL
EDUCATION.
WE OVERSAMPLED AMERICAN INDIAN
PARTICIPANTS FOR THAT TYPE OF
APPROACH.
SO THERE WERE SIX THEMES THAT
EMERGED FROM THIS QUALITATIVE
SURVEY.
I'M NOT GOING TO GO INTO EACH
ONE OF THEM BUT I WANT TO
HIGHLIGHT A FEW BECAUSE THEY'RE
VERY RELEVANT TO SOME OF OUR
DISCUSSION THAT HAPPENED TODAY.
THE FIRST IS ABOUT TIMING, WHEN
SHOULD WE RETURN THE RESULTS.
YOU BROUGHT UP PREGNANT WOMEN.
SO IN THIS GROUP, PREGNANT WOMEN
THAT ANSWERS THIS QUESTION ABOUT
TIMING, THEY SPECIFICALLY LEAN
TOWARDS -- IT WAS BASED UPON
RESULT TYPE AND FUTURE CHILD
BEARING DECISIONS.
SO WOMEN SAID IF I WAS GOING TO
HAVE MORE CHILDREN, I WOULD LIKE
TO KNOW THIS.
IRRESPECTIVE OF WHEN THIS WAS
RETURNED.
IF I WAS NOT HAVING MORE
CHILDREN, I PROBABLY WOULD NOT
CARE AS MUCH.
DETERMINING VALUE.
SO THIS WAS THE QUESTION WE
ASKED THEM, HOW DO YOU MAKE
DECISIONS ABOUT PERSONAL VALUE?
AND THIS WAS A VERY INTERESTING
INTERACTION.
A LOT OF THEM SPOKE ABOUT HOW
THEY WOULD GO TO THEIR FRIENDS
OR FAMILY TO DECIDE IF THEY HAD
A SIMILAR EXPERIENCE, SO THAT
THEY COULD MAYBE MAKE A CHOICE
BASED ON WHAT THEY LEARNED.
A FEW PARTICIPANTS ALSO POINTED
TO THE RESEARCHER AS BEING THE
EXPERT, AND SAID THEY WOULD LIKE
MORE DIALOGUE IN THAT -- AND
CONVERSATION IN THAT PROCESS,
BECAUSE THEY DON'T KNOW WHAT
THEY DON'T KNOW, AND WOULD
APPRECIATE A MORE OPEN DIALOGUE
SAYING THIS IS WHAT WE THINK,
WHAT DO YOU THINK.
SO I THINK -- AND AS OPPOSED TO
WHAT I WENT IN THINKING IS THAT
THEY WOULD WANT TO MAKE ALL THE
DECISIONS, I THINK IT WAS A
LITTLE DIFFERENT OUTCOME WHERE
THEY SAW MORE ENGAGEMENT FROM
THE RESEARCHER.
I THINK THAT'S SOMETHING FOR US
TO KEEP IN MIND AS WE THINK
ABOUT RESPONDING TO QUESTIONS
REGARDING UNCERTAINTY OF RESULT
OR THE PROCESS OF RETURNING THE
RESULTS TO THEM.
THEN THE THIRD ONE WAS
PARTICIPANT MOTIVATIONS.
I THINK JEFF BROUGHT THIS UP
EARLIER.
MANY PARTICIPANTS JUST
PARTICIPATED BECAUSE THEY WANTED
TO DO GREATER GOOD.
AND SO IT'S NO EXPECTATION OF
RECEIVING RESULTS, THEY EVEN
SAID, WELL, I DIDN'T KNOW THAT
WAS AN OPTION.
AND I REALLY DON'T THINK I WOULD
WANT IT.
SO WHILE MANY PEOPLE WANT IT,
SOME MAY NOT, AND SO IT GOES
BACK TO PROVIDING THEM THE
CHOICE IN THE INFORMED CONSENT
AND ASKING THEM HOW THEY WOULD
WANT IT DONE.
SO THE MAIN TAKEAWAYS FROM THE
WORK THAT WE DID, AND AGAIN
KEEPING IN MIND THAT IT
REPRESENTS ONE COHORT OF ECHO
AND IT SPEAKS TO SORT OF THE
OPINIONS OF A CERTAIN GEOGRAPHIC
GROUP, THAT THE PARTICIPANTS IN
THIS STUDY ATTRIBUTED HIGHER
VALUE TO RESULTS THAT ALLOWED
FOR MEANINGFUL COMPARISONS.
LOWER VALUE WAS ATTRIBUTED TO
RESULTS OF UNKNOWN CERTAINTY.
THE VALUE OF RESULTS WAS INS
INFLUENCED BY TIMING OF RETURN,
PARTICULARLY IN RELATION TO
PREGNANT PEOPLE, AND
PARTICIPANTS ASKED FOR MORE
RESEARCHER ENGAGEMENT TO HELP
MAKE DECISIONS REGARDING THE
VALUE OF INDIVIDUAL RESEARCH
RESULTS.
SO FUTURE DIRECTION.
YOU KNOW ANY GOOD RESEARCH WILL
LEAD TO NEW QUESTIONS OTHERWISE
YOU HAVEN'T DONE YOUR JOB.
SO THERE'S LOTS OF DIRECTIONS
THIS COULD GO.
ONE OF THE THINGS IS DEFINITELY
LOOKING AT EXPLORATION OF
PARTICIPANT PERSPECTIVES FROM
DIFFERENT GROUPS.
I THINK WE DON'T KNOW AS MUCH AS
WE SHOULD WITH VARIOUS GROUPS.
AND THEN THE OTHER GROUP, THE
MAJOR STAKEHOLDER IN THIS
PROCESS IS THE PROVIDERS.
HOW DO THEY FEEL ABOUT RECEIVING
PARTICIPANTS GETTING THESE BACK
BECAUSE ULTIMATELY THEY ARE
GOING TO BE THE ONES THAT MAY
HAVE TO ANSWER SOME OF THESE
QUESTIONS.
HOW DO THEY FEEL ABOUT THEIR
KNOWLEDGE AND COMFORT WITH
TOPICS SUCH AS ENVIRONMENTAL
CHEMICALS AND SO FORTH, AND WHAT
DO WE NEED TO DO TO HELP THEM
BRING ALONG IN THIS PROCESS?
NEXT SLIDE, AND THAT'S THE LAST
ONE.
THANKS TO ECHO FOR THE FUNDING.
ARE WE TAKING QUESTIONS NOW?
WE ARE?
OKAY.
>>WE CAN TAKE QUESTIONS THE
NEXT TIME.
YES.
>>THANKS, JYOTI, THAT WAS
GREAT.
I'M CURIOUS ABOUT IN TERMS OF
EXPLORING PERSPECTIVES ACROSS
GROUPS.
ON YOUR LAST SLIDE.
WHAT KINDS OF THINGS WOULD BE
ASK IN THE PROCESS OF DOING
THAT?
WHAT DO YOU NEED TO REALLY GET
TO THE BOTTOM OF WHEN YOU'RE
LOOKING INTO THAT SORT OF THING?
>>YES.
SO I WOULD -- I THINK ONE OF THE
THINGS WE ALLUDED TO EARLIER IS
HOW THEY WOULD WANT IT RETURNED,
BECAUSE THERE MIGHT BE
DIFFERENCES IN CULTURAL WAYS OR
OTHER THINGS ON HOW THEY WOULD
WANT TO BE RETURNED.
I THINK EVEN IN TERMS OF
DIFFERENCES LOOKING AT WHETHER
OR NOT THEY WOULD WANT MORE
IN-PERSON SORT OF RETURN VERSUS
TECHNOLOGY, AND THAT A LOT OF
TIMES DEPENDS ON THE
GEOGRAPHICAL LOCATIONS.
I KNOW THAT MANY PARTICIPANTS IN
THE GROUP RESPONDED ABOUT HOW
THEY WOULD BE FINE HAVING A
DATABASE AND GOING IN.
WHILE SOMEBODY ELSE SAYS I WOULD
REALLY LIKE A PHONE CALL.
SO I THINK THAT DIFFERS ACROSS
PARTICIPANTS' GROUPS TOO.
>>YES, MATT.
>>JYOTI, THANKS A LOT.
THAT'S GREAT WORK.
IT'S A LOT OF WORK AND
CONGRATULATIONS ON YOUR
DOCTORATE.
THAT'S FANTASTIC.
>>THANK YOU.
>>SO ONE OF YOUR AIMS YOU
STARTED OUT WAS TO COMPARE YOUR
WHITE PARTICIPANTS WITH YOUR
AMERICAN INDIAN PARTICIPANTS.
SO I'M WONDERING IN YOUR
QUANTITATIVE OR YOUR QUALITATIVE
WORK, DID YOU FIND DIFFERENCES,
AND IF SO, WHAT?
>>YES, GREAT QUESTION.
I WAS TRYING TO CONDENSE, LIKE,
FOUR YEARS OF WORK INTO 15
MINUTES, SO I DID NOT HAVE THAT
UP.
WE ACTUALLY IN THE QUANTITATIVE
SERVICE, WE DID NOT FIND
SIGNIFICANT DIFFERENCES.
BETWEEN AMERICAN INDIAN
PARTICIPANTS AND THE WHITE
PARTICIPANTS.
IN THE QUALITATIVE,
UNFORTUNATELY WE DID NOT HAVE
ENOUGH IN THE SAMPLE, AND SO I
THINK WE'LL HAVE TO CONTINUE TO
EXPLORE THAT.
WHICH IS VERY INTERESTING,
BECAUSE I ACTUALLY WENT IN WITH
THE HYPOTHESIS THAT AMERICAN
INDIAN PARTICIPANTS WOULD
PROBABLY HAVE A HIGHER PERCEIVED
VALUE FOR RESULTS IRRESPECTIVE
OF RESULT TYPE, GIVEN THE
NOTIONS OF RESPECT AND
RECIPROCITY IN THE CULTURE.
SO THAT WAS WHAT I WAS
HYPOTHESIZING SO IT WAS NOT THE
CASE.
>>JOHNNYE?
>>NICE WORK, JYOTI.
AND I ALSO LIKE THAT YOU ENDED
WITH THE QUESTION OF HOW TO
BRING PROVIDERS ALONG, BECAUSE
THAT IS A CONFLICT THAT WE'VE
SEEN A LOT WHERE OUR
PARTICIPANTS REALLY WANT RESULTS
TO GO INTO THEIR RECORD, SO IT
CAN BE CONSIDERED.
AND CLINICIANS, WHEN THEY DON'T
KNOW WHAT TO DO WITH SOMETHING,
THEY'RE VERY NERVOUS ABOUT IT
BEING IN THE RECORD.
SO WONDERED IF YOU HAD SOME
IDEAS ABOUT A STRATEGY TO
IMPLEMENT TO START MAKING THAT
CHANGE?
>>CAN I LEAVE THAT UP TO THE
DISCUSSION SECTION?
I DON'T KNOW AS OF NOW.
I'M GOING TO HAVE TO THINK ABOUT
THAT.
YEAH, WE CAN TALK.
>>I HAVE A QUESTION.
>>REALLY INTERESTING WORK.
I WAS WONDERING IF YOU ASKED
WHETHER THERE WAS A PREFERENCE
FOR OPTING IN TO GETTING
RESULTS, LIKE DURING THE CONCEPT
PROCESS, OR THAT BEING THE
DEFAULT AND PEOPLE WOULD OPT OUT
IF THEY DID NOT GET RESULTS?
>>I DID NOT ASK THAT QUESTION.
BUT DURING THE QUALITATIVE
INTERVIEW PROCESS, I THINK THAT
THAT CAME UP ONCE OR TWICE WHEN
PEOPLE SAID, OF COURSE I WOULD
HAVE A CHOICE, RIGHT?
SO IT WAS AN ASSUMED ASSUMPTION
ON THEIR PART.
THE OTHER THING THAT CAME UP IS
A LOT OF PEOPLE WERE INTERESTED
ABOUT LEARNING CHANGES TO RESULT
OR PROGRESS ALONG THE WAY, SO IF
I SAID YES TO SOMETHING, I WOULD
WANT TO KNOW IF YOU FOUND
SOMETHING DIFFERENTLY SINCE WHEN
I SAID YES, AND SO THAT WAS A
BIG PART ABOUT KEEP ME INFORMED
ABOUT HOW THINGS ARE GOING ALONG
THE WAY SO THAT I CAN MAKE A
BETTER DECISION WHEN IT COMES
TIME TO GET THE RESULT.
SO THAT WAS AN INTERESTING POINT
AS WELL.
>>ANY OTHER QUESTIONS?
THANK YOU SO MUCH FOR A
WONDERFUL PRESENTATION.
>>THANK YOU.
>>NEXT PRESENTING ON PARENT
VIEWS ON CHEMICAL EXPOSURE
RESULTS WILL BE JULIE HERBSTMAN
FROM COLUMBIA UNIVERSITY.
>>THANK YOU.
IT'S SO NICE TO FOLLOW JYOTI,
WHO I'VE HAD THE REAL PLEASURE
OF WORKING WITH IN THE ECHO
CONSORTIUM, AND ALSO AS PART OF
A SUPPLEMENT THAT I DIDN'T HAVE
A CHANCE TO MENTION EARLIER THAT
WE'VE GOTTEN TO LOOK AT.
IT'S CALLED NOT WHETHER BUT HOW,
LOOKING AT THE BIOETHICS OF
REPORT-BACK.
SO I'VE TAPPED A COUPLE OF YOU
IN THIS ROOM.
THANK YOU FOR TAKING THE TIME.
I APPRECIATE YOUR INPUT.
AND ONE OF THE THINGS WE'VE
LEARNED AS PART OF THAT PANEL IS
THAT IT'S KIND OF HARD TO TALK
ABOUT THESE THINGS IN THE
ABSTRACT, SO WHAT I'M HOPING TO
DO TODAY IS PROVIDE YOU WITH ONE
CASE STUDY BASICALLY FROM OUR
OWN WORK WHERE WE IMPLEMENTED A
REPORT-BACK IN THE COHORT THAT I
WORKED WITH.
SO I'LL TELL YOU A LITTLE BIT
ABOUT THAT, BUT THE TITLE OF MY
TALK IS "PARENT VIEWS ON
CHEMICAL EXPOSURE RESULTS," AND
I'M SO HONORED, AS OTHERS HAVE
SAID, TO BE IN THE ROOM WITH
REAL LIVE STUDY PARTICIPANTS WHO
CAN TELL YOU THEMSELVES WHAT
THEY THINK ABOUT THEIR VIEWS ON
CHEMICAL EXPOSURE RESULTS.
SO I'M GOING TO FLIP THIS A
LITTLE BIT AND TELL YOU IN THIS
VERY INTIMATE SETTING OF 30
PEOPLE IN THE ROOM AND 200 OR SO
ONLINE ABOUT MY OWN INSECURITIES
AS A RESEARCHER, TRYING TO
IMPLEMENT A REPORTBACK WITHOUT
REALLY HAVING BEEN TRAINED TO DO
THIS.
SO I'M HOPING TO SHARE THAT
PERSPECTIVE WITH YOU.
SO I WANT TO JUST GIVE YOU SOME
FRAMING A LITTLE BIT ABOUT THE
PLACE THAT I WORK, SO I HAVE
BEEN AT THE COLUMBIA CENTER FOR
CHILDREN'S ENVIRONMENTAL HEALTH
SINCE 2006, BEEN DIRECTING THE
CENTER FOR THE PAST FOUR YEARS
OR SO, AND THE CENTER HAS BEEN
AROUND FOR 25 YEARS, AND SO
SINCE 1998, WE'VE BEEN TRYING TO
UNDERSTAND HOW PRENATAL
ENVIRONMENTAL EXPOSURES IB
FLEINFLUENCE A VARIETY OF
CHILDREN'S HEALTH OUTCOMES.
AND SO I ALSO WANT TO ORIENT YOU
TO WHERE I'M WORKING.
SO WE'RE BASED IN NORTHERN
MANHATTAN, IN THE NORTHERN TIP
OF MANHATTAN ISLAND, NEW YORK
CITY.
IT'S A POPULATION BASED AROUND
THE HOSPITAL WHERE WE ARE.
I DON'T KNOW IF YOU CAN SEE MY
POINTER OR IF IT REALLY MATTERS,
BUT BASICALLY THE POPULATION
COMES FROM WASHINGTON HEIGHTS,
HARLEM AND THE SOUTH BRONX.
AND SO WE HAVE THREE
ADMINISTRATIVE COHORTS, BUT YOU
MIGHT THINK ABOUT THEM AS ONE
REALLY LONG CONTINUOUS COHORT
THAT'S BEEN GOING ON FOR 25
YEARS, AND SO THE OLDEST
PARTICIPANTS ARE 25, AND WE'RE
STILL RECRUITING PREGNANT PEOPLE
AS WELL.
THE COHORTS, THE DEMOGRAPHICS OF
THE COHORTS ARE PRIMARILY
SELF-IDENTIFIED AS BLACK AND
HISPANIC, MAINLY DOMINICAN.
AND ABOUT A THIRD OF OUR
PARTICIPANTS HAVEN'T COMPLETED A
HIGH SCHOOL EDUCATION.
AND THAT BECOMES REALLY
IMPORTANT WHEN WE START THINKING
ABOUT HOW WE COMMUNICATE
RESULTS.
SO THE CENTRAL FOCUS OF OUR WORK
FOR MANY, MANY YEARS HAS BEEN
TRYING TO UNDERSTAND HOW
PRENATAL EXPOSURE TO AIR
POLLUTION AFFECTS CHILDREN'S
HEALTH.
IN THE NEXT SLIDE, I WON'T GO
INTO ANY AMOUNT OF DETAIL BUT
THERE'S LOTS AND LOTS OF WAYS TO
ASSESS AIR POLLUTION GOING FROM
AREA MEASURES THAT TALK ABOUT
AIR POLLUTION HAZARDS, ALL THE
WAY TO SORT OF THE BIOLOGICALLY
EFFECTIVE DOSE OF WHAT'S GOING
ON IN SOMEONE'S BLOOD.
AND I THINK THIS HAS
IMPLICATIONS FOR THE
CONVERSATION WE HAD EARLIER
TODAY, WHICH REALLY, YOU KNOW,
THERE'S DIFFERENT RULES AND
REGULATIONS ABOUT HOW YOU NEED
TO DO THINGS, DEPENDING ON HOW
YOU'RE MEASURING EXPOSURE.
SO WHAT I'M GOING TO TALK TO YOU
ABOUT ACTUALLY IS EXPOSURE THAT
WE MEASURED USING THESE SILICONE
WRIST BAND SAMPLERS.
ON THE NEXT SLIDE, THIS IS A
COLLABORATION WITH RESEARCHERS
AT O OREGON STATE UNIVERSITY, TS
IS LIKE YOUR USUAL LIVESTRONG
BAND THEY PREPARE, BASICALLY
SEAL IT UP, AND AS SOON AS THEY
MAIL -- THEY MAIL TO US.
AS SOON AS WE TAKE IT OUT OF THE
BAG TO GIVE TO A PARTICIPANT, IT
STARTS -- THIS WAS DONE IN NIEHS
SPONSORED R21/R33 WORK.
IT'S IMPORTANT TO THINK ABOUT
THESE ISSUES OF REPORTBACK
BECAUSE WE BUILT IT IN.
AT THE VERY BEGINNING OF THE
STUDY, WE KNEW WE WERE GOING TO
DO IT, WE ALLOCATED RESOURCES TO
IT, BUDGETED TIME, HAD THE
EXPERTISE.
AND IN THIS STUDY, THE SILICONE
BANDS CAN MEASURE 1500
COMPOUNDS.
WE FOCUSED ON PAHs, COMBUSTION
RELATED AIR POLLUTANTS.
SO ONE OF THE BENEFITS OF
WORKING WITH THE OREGON STATE
GROUP IS THAT DIANA ROHLMAN, WHO
IS A RESEARCHER THERE, IS REALLY
AN EXPERT IN THIS SPACE.
AGAIN, I'M AN ENVIRONMENTAL
EPIDEMIOLOGIST.
I DIDN'T HAVE A LOT OF
CONFIDENCE THAT WE COULD DO THIS
REAL WELL.
AND SO I FEW WE WANTED TO DO IT,
I JUST DIDN'T -- I WASN'T SURE
WE -- I WASN'T SURE WE WOULD DO
A GOOD JOB AND ACTUALLY I WAS
REALLY WORE OWED TH WORRIED THAO
MORE HARM THAN GOOD.
YOU'VE HEARD THAT BALANCE OVER
AND OVER AGAIN THROUGH OTHER
SPEAKERS.
SO ONE OF THE THINGS WE WERE
ABLE TO DO IS REALLY LEVERAGE
WORK THAT DIANA HAD DONE IN
OTHER POPULATIONS.
SO SHE HAS WORKED WITH FOLKS IN
OREGON, FOLKS WHO WERE EXPOSED
TO WILDFIRES OUT ON THE PACIFIC
NORTH WEATHER, PEOPLE WHO WERE
EXPOSED TO HURRICANE -- ONE OF
THE HURRICANES IN TEXAS,
FRACKING IN OHIO, SO SHE HAD A
LOT OF EXPERIENCE DOING THIS
KIND OF WORK.
AND IN TERMS OF PAHs, WE WERE
ABLE TO TAKE A LOT OF THE
MATERIALS THAT THEY HAD
DEVELOPED AND ADAPT THEM, BORROW
SOME OF THEM AND ADAPT THEM, AND
THAT SHOWS SOME RT PORTABILITY
OF SOME -- YOU KNOW, OF THE IDEA
THAT THERE CAN BE CENTRALIZED
RESOURCES THAT ARE APPLICABLE
ACROSS MULTIPLE POPULATIONS.
ONE OF THE REALLY IMPORTANT
THINGS THAT WE HAD TO DO,
THOUGH, WAS TRANSLATE IT INTO
SPANISH.
WE HAVE A STUDY POPULATION WHERE
THE MAJORITY OF PEOPLE PREFER TO
SPEAK IN SPANISH.
NOT THAT THEY CAN'T SPEAK IN
ENGLISH, BUT THEY PREFER TO BE
COMMUNICATED TO IN SPANISH.
SO WE SPENT A LOT OF TIME
TRANSLATING THE MATERIALS, NOT
JUST INTO SPANISH, BUT INTO
CARIBBEAN SPANISH, WHICH IS
USING LANGUAGE AND CULTURE THAT
PEOPLE ARE FAMILIAR WITH AND
THAT THEY'RE GOING TO
UNDERSTAND.
SO OUR REPORTS HAVE BOTH
QUALITATIVE AND QUANTITATIVE
RESULTS.
THIS IS AN EXAMPLE OF THE
QUALITATIVE RESULTS WHERE WE
BASICALLY LISTED OUT OF THE 62
PAHs THAT WE TRIED TO MEASURE,
HERE'S WHAT WE FOUND IN YOUR
WRIST BAND.
AND ON THE NEXT SLIDE, THE
QUANTITATIVE RESULTS.
I HAVE TO SAY HERE, WE LEANED
VERY, VERY MUCH ON GUIDANCE THAT
WAS CREATED BY JULIA AND HER
TIME AT SILENT SPRING.
THEY PUT TOGETHER A REALLY
BEAUTIFUL HANDBOOK THAT TALKED
ABOUT HOW DO YOU CREATE A
TEMPLATE FOR PEOPLE TO
UNDERSTAND A GRAPH, FOR EXAMPLE.
AS THE SCIENTISTS IN THIS ROOM
WE'RE USED TO SEEING DATA THIS
WAY, BUT NORMAL PEOPLE -- MAYBE
THAT'S NOT THE RIGHT WORD, BUT
REGULAR PEOPLE ARE NOT.
SO WE LEANED ON THE RESOURCES
THEY HAD DEVELOPED TO TRY TO
FRAME THIS OUT TO SORT OF SAY,
OKAY, HERE'S HOW WE'RE GOING TO
PRESENT YOUR RESULTS, HERE'S THE
ICONS WE'RE GOING TO USE.
HOW DO YOU FIND YOUR RESULT IN
THIS STORY?
AND WHAT ARE ALL THESE OTHER
DOTS AND WHAT DO THEY MEAN AND
HOW DO YOU PUT THAT INTO
CONTEXT?
SO USING THOSE RESOURCES HELPED
US TO CREATE OUR REPORT
CERTAINLY.
THE OTHER THING WE DID WAS THAT
WE KNEW WE WEREN'T GOING TO BE
ABLE TO GIVE PEOPLE REPORTS ONE
BY ONE, SO WE DEVELOPED A
YOUTUBE VIDEO WHERE WE PUT
SPANISH SUBTITLES ON SO THAT
PEOPLE WOULD HAVE A RESOURCE.
IF THEY'RE AT HOME BY THEMSELVES
READING THIS RESULT, IF THEY GOT
LOST, IF THEY DIDN'T KNOW WHAT
TO DO, THEY COULD GO TO THE
VIDEO AND SORT OF TRACK THEIR
WAY THROUGH.
SO AS I SAID, WE WERE ABLE TO
BORROW SOME OF THE RESOURCES
THAT HAD BEEN DEVELOPED BY DIANA
AND HER CREW, SO HERE'S AN
EXAMPLE.
ONE OF THE THINGS WE LIKE TO BE
ABLE TO DO, AND THIS WAS
DISCUSSED A LITTLE BIT EARLIER
TOO, IS WE LIKE TO TELL PEOPLE
WHEN WE'RE GIVING THEM
INFORMATION, WHAT ARE THINGS YOU
CAN DO TO REDUCE YOUR EXPOSURE?
INDEPENDENT OF YOUR ACTUAL
EXPOSURE IN GENERAL, WHAT ARE
THINGS THAT YOU CAN DO?
AND SO ONE OF THE SOURCES OF PAH
EXPOSURE HAS BEEN CANDLE USE, SO
BURNING CANDLES.
AND THIS IS SOMETHING THAT WE
DIDN'T FEEL COMFORTABLE SAYING
DON'T BURN CANDLE, BUT THERE'S
WAYS THAT YOU CAN DO IT MORE
SAFELY.
SO THEY HAD DEVELOPED THIS
PARTICULAR RESOURCE FOR ANOTHER
COMMUNITY THAT WE WERE ABLE TO
TAKE AND SAY, HEY, IT'S RELEVANT
FOR US TOO.
AGAIN, ONCE WE TRANSLATED IT.
HOWEVER, THERE WERE SOME VERY
CONTEXTUALLY -- YOU KNOW, SOME
THINGS THAT REALLY DIDN'T
TRANSLATE VERY WELL.
SO THIS IS SOMETHING THAT WE
LEARNED IN OUR STUDY THAT A
MAJOR SOURCE OF PAH IS THE USE
OF ALCANFOR.
MANY PEOPLE IN OUR COMMUNITY USE
THESE ALCANFORS, CUBES, IN
DIFFERENT KINDS OF WAYS, AND WE
WANTED TO UNDERSTAND HOW.
AND ALSO BE CULTURALLY SENSITIVE
TO THE IDEA THAT THIS IS PART OF
A CULTURE AND WE SHOULDN'T COME
IN AND BE LIKE, NO, DON'T DO
THAT.
AND SO WE NEED TO UNDERSTAND
BETTER HOW PEOPLE ARE USING IT
SO WE CAN THINK THROUGH WITH THE
COMMUNITY ABOUT WHAT ARE THINGS
WE CAN AND SHOULD SAY.
SO NOW I WANT TO TELL YOU A
LITTLE BIT ABOUT SORT OF GOING
IN, ALL THE THINGS I WAS WORRIED
ABOUT, AND THEN WHAT REALLY
HAPPENED.
SO ON THE NEXT SLIDE, YOU'LL SEE
OUR EXPECTATION.
THESE ARE THINGS YOU'VE HEARD
OVER AND OVER AND OVER AGAIN IN
THE PREVIOUS SPEAKERS, LIKE WHAT
DO WE DO ABOUT THIS UNCERTAINTY?
WE'RE USED TO TALKING ABOUT
UNCERTAINTY, ARE WE GOING TO BE
ABLE TO COMMUNICATE IT AND IS IT
GOING TO BE TOO OFFPUTTING?
AND BASICALLY WHAT WE FOUND IS
THAT PEOPLE DIDN'T CARE.
THEY DIDN'T -- THEY WEREN'T -- I
WAS SO FIXATED ON HOW ARE WE
GOING TO DO THIS, HOW ARE WE
GOING TO CONTEXTUALIZE, AND
PEOPLE WERE LIKE, WE GET IT.
IT'S OKAY.
YOU KNOW -- WE KNOW THAT YOU
DON'T KNOW EXACTLY WHAT THIS
EXPOSURE MEANS FOR MY HEALTH,
BUT I APPRECIATE HAVING -- I
APPRECIATE KNOWING ABOUT IT, AND
KNOWING ABOUT IT IS GOING TO
ALLOW ME TO MAKE SOME DECISIONS
ABOUT WHETHER OR NOT I WANT TO
DO THINGS DIFFERENTLY.
SO AGAIN, WE WERE WORRIED ABOUT
THE LONG DELAY BETWEEN
MEASUREMENT AND REPORTBACK.
SO WE KNOW THAT LABS, DATA TAKE
A WHILE TO GENERATE, THEY HAVE
TO BE DONE IN BATCHES, IT TAKES
A LONG TIME FOR US TO DEVELOP
THE REPORTS.
WE WERE WORRIED THAT WE MEASURED
EXPOSURE DURING PREGNANCY, WE'RE
GIVING PEOPLE INFORMATION BACK
TWO YEARS LATER, AS WAS
MENTIONED EARLIER, AND THAT'S --
YOU KNOW, WE WISH WE COULD DO IT
FASTER, BUT THAT'S THE REALITY.
AND THEN WHAT WE GOT WAS, YES,
WE'D LIKE IT SOONER BUT WE'RE
HAPPY WE GOT IT.
AND SOME OF THAT IS TO MAKE
DECISIONS ABOUT FUTURE
PREGNANCIES OR WAYS TO, IF YOU
HAVE AN ASTHMATIC CHILD, FOR
EXAMPLE, REDUCING EXPOSURE
REALLY STILL IS VERY BENEFICIAL
AND THERE'S WAYS THAT IT CAN
IMPROVE HEALTH.
SO THE LAST WAS THE THING I
PROBABLY WORRIED THE MOST ABOUT,
WHAT ARE WE GOING TO DO ABOUT
THIS QUANTITATIVE DATA?
YOU KNOW, WE FOLLOWED THE
GUIDANCE, BUT I WAS QUITE
CONCERNED THAT WE WOULDN'T BE
ABLE TO COMMUNICATE THIS
EFFECTIVELY.
SO WE SPENT A LOT OF TIME AGAIN
PROVIDING EXTRA RESOURCES AND
EXTRA SUPPORT, AND I THINK THE
THINGS THAT WERE ACTUALLY THE
MOST HELPFUL WERE THE INFO
SESSIONS, THE Q & As, SO WE
HOSTED THREE Q & As ALL WITH
RESEARCHERS WHO ARE BILINGUAL,
WHO COULD ANSWER QUESTIONS.
AND I THINK ONE OF THE COOLEST
THINGS ACTUALLY WAS WHEN YOU
COULD GET A NUMBER OF
PARTICIPANTS IN A ROOM TOGETHER.
SO ONE PARTICIPANT MIGHT BE LIKE
I DON'T HAVE ANY QUESTIONS BUT
THEN SOMEBODY ELSE WILL ASK A
QUESTION, I DO HAVE THAT
QUESTION, THAT'S AN INTERESTING
QUESTION.
AND THEN THERE WAS A DISCUSSION
AND DIALOGUE WITHIN PARTICIPANTS
THAT WAS REALLY VALUABLE, I
THINK, TO IMPROVING THEIR
UNDERSTANDING AND HELPING US TO
UNDERSTAND HOW WE COULD CONVEY
INFORMATION BETTER.
SO I GAVE YOU ALL THESE
EXPECTATION AND REALITIES, LIKE
HOW DO WE KNOW ANY OF THIS?
WE ASKED.
SO AFTER OUR REPORTS, WE
DEVELOPED AN EVALUATION TOOL,
SURVEY, THAT PEOPLE COULD
RESPOND TO, AND THEN THROUGH THE
Q & A SESSIONS, THROUGH THE INFO
SESSIONS, WE LEARNED A LOT ABOUT
HOW PEOPLE RESPONDED TO WHAT WE
HAD DONE, WE LEARNED ABOUT
THINGS THAT WE COULD DO BETTER
AND LIRNE LEARNED, AGAIN, THAT F
MY INSECURITIES -- SOME OF THEM
MAY BE VALID BUT SOME OF THEM,
WE COULD BE MORE CONFIDENT GOING
IN, SO I THINK THE NEXT TIME WE
DO THIS, I FEEL BETTER THAT THAT
WILL BE EQUIPPED.
NEXT SLIDE, SO JUST TO
SUMMARIZE, WE'RE NOT REALLY
TALKING ABOUT WHETHER TO RETURN
RESULTS AT THIS POINT, WE'RE
JUST TALKING ABOUT HOW TO DO IT
IN THE MOST EFFECTIVE WAY.
AND THERE ARE SOME ASPECTS OF
THE RESULTS RETURN THAT ARE
GENERALIZABLE, AND SOME THAT ARE
CONTEXT-SPECIFIC.
AND SO -- AND SORT OF
RESEARCHERS, MY PERSPECTIVE ON
HOW THE RESULTS WILL BE RECEIVED
AREN'T ALWAYS MATCHING REALITY
OF HOW THE PARTICIPANTS RECEIVE
THEM.
WHICH IS WHY IT SO IMPORTANT TO
GET DIRECT FEEDBACK FROM
PARTICIPANTS.
IT'S MY LAST SLIDE.
SO JUST IN TERMS OF
RECOMMENDATIONS, I THINK HAVING
WORKSHOPS OR TRAINING SESSIONS
THAT BOOST CONFIDENCE FOR
RESEARCHERS SO THAT THERE ARE
RESOURCES AVAILABLE, AND WE CAN
TO A GOOD JOB OR A GOOD ENOUGH
JOB, RIGHT?
SO WE MIGHT NOT BE PERFECT, BUT
WE CAN'T LET PERFECT BE THE
ENEMY OF THE GOOD IN THIS CASE.
AND THE EVALUATIONS WERE
ABSOLUTELY CRITICAL SO THAT WE
COULD KNOW WHAT WE DID WELL AND
WHERE THERE'S SPACE TO IMPROVE.
AGAIN, SOME ASPECTS OF THE
REPORT WERE GENERALIZABLE, AND
SOME REALLY WERE NOT.
AND THEN
THE BIGGEST THING I COME BACK TO
OVER AND OVER AGAIN, TRAINING
FOR REPORTBACK REQUIRES TIME AND
RESOURCES.
IF WE HADN'T PLANNED TO DO IT
INITIALLY, I WOULD FEEL EVEN
LESS CONFIDENT THAN WHERE WE
STARTED.
THE NEXT SLIDE IS
ACKNOWLEDGMENTS.
THE BIGGEST ONE IS STUDY
PARTICIPANTS FOR THEIR TIME
CONTRIBUTING TO THE RESEARCH,
AND ALSO THE RESEARCH -- YOU
KNOW, THEIR TIME AND FEEDBACK OF
HOW WE DID IN TERMS OF REPORTING
BACK.
THAT'S ALL.
>>THANK YOU, JULIE, JE JULIA.
CARMEN.
>>QUESTION, ALSO ANOTHER
RECOMMENDATION.
SOMETHING THAT HELPED US TO MAKE
OUR REPORTBACK MORE RESPONSIVE
TO OUR PARTICIPANTS WAS TO HAVE
COMMUNITY ADVISORY TEAM THAT HAS
REPRESENTATION FROM THE
PARTICIPANTS.
AND THE PEOPLE THAT WORK IN THE
CLINICS WHERE WE DO OUR
RESEARCH.
THAT HAS HELPED US DEVELOP A
SOUNDING BOARD WHERE EVERY
MATERIAL THAT -- EVERY TIME WE
DO A REPORTBACK, EVEN IF IT'S A
GROUP OR INDIVIDUAL, WE BRING
THE MATERIALS, THEY HELP US
DEVELOP THE MATERIAL SO THAT
THEY ARE CULTURALLY COMPETENT,
SO THAT THEY HAVE THE
INFORMATION BECAUSE ONE THING
WE'VE BEEN DOING THIS SINCE
2015.
ONE THING THAT OUR PARTICIPANTS
WANT IS NOT JUST WHAT DO I HAVE
IN MY BODY, HOW MUCH OF IT OR IS
IT BAD OR GOOD, OR WHAT CAN BE
THE POSSIBLE CONSEQUENCES.
PEOPLE WANT TO KNOW WHAT TO DO.
PEOPLE WANT TO KNOW WHAT ARE THE
DIFFERENT OPTIONS THAT I HAVE?
AND HAVING THAT ADVISORY TEAM IS
REALLY IMPORTANT TO BE ABLE --
IN OUR CASE, WE ARE ABLE TO
DEVELOP SHORT ANIMATED VIDEOS
EXPLAINING EACH ONE OF THE
SUBSTANCES AND INCLUDE
INFORMATION ON PREVENTION,
DEVELOPING INFO GRAPHS AND
PRINTED MATERIALS THAT CAN GO TO
THE CLINICS WHERE THE PEOPLE
THAT WE SERVE ATTEND SO THAT THE
CLINICIANS, OUR COLLABORATORS
ARE ALSO INFORMED AND CAN
PROVIDE INFORMATION.
FLOOB
>>THOSE ARE GREAT SUGGESTIONS.
>>YES, THANK YOU.
>>IN MY EXPERIENCE,
PARTICIPANTS OFTEN WANT TO BE IN
COMMUNITY, ARE INTERESTED IN
BEING IN COMMUNITY WITH EACH
OTHER SO HAVING A GROUP INFO
SESSION MAKES SENSE.
DID YOU HAVE INSTANCES WHERE
PEOPLE WERE NOT INTERESTED
BECAUSE OF CONFIDENTIALITY REAPS
AND IF SO, WHAT WOULD YOU DO
ABOUT THAT SITUATION?
>>SO I THINK IT'S A GOOD
QUESTION.
I THINK WE PRESENTED THE INFO
SESSION AND THE Q & A SESSION,
ACTUALLY WE HAD SOME OF THEM IN
PERSON AND SOME OF THEM ON I'D
SAY ZOOM BUT IT WASN'T REALLY
ZOOM, IT WAS MORE LIKE FACETIME
BECAUSE MOST PEOPLE WERE USING
SMARTPHONES.
SO I THINK WE PRESENTED IT, YOU
DON'T HAVE TO HAVE YOUR CAMERA
ON, IF THAT'S NOT AN ENVIRONMENT
YOU'RE COMFORTABLE IN, THAT'S
FINE.
THERE'S OTHER WAYS TO REACH OUR
STAFF AND TO ASK YOUR QUESTIONS.
AND SO WE SORT OF HAVE PROVIDED
SORT OF DIFFERENT WAYS TO MAKE
SURE THAT WE WERE ACCESSIBLE SO
THAT PEOPLE COULD HAVE THEIR
QUESTIONS ANSWERED ONE WAY OR
THE OTHER.
>>MATT?
>>JULIE, THAT'S GREAT.
IT'S SO GREAT TO HEAR FROM YOU
AND JYOTI TO HAVE SOME EMPIRICAL
DATA ON WHAT IT MEANS TO
ACTUALLY REPORT BACK IN
DIFFERENT SITUATIONS.
CAN I GET YOU TO COGITATE A
LITTLE BIT ABOUT THIS TAKING
CENTRALIZED RESOURCES AND
ADAPTING THEM FOR LOCAL CONTEXT,
AND THINK ABOUT A PROGRAM LIKE
ECHO, WHICH IS NATIONWIDE, AND
YOU KNOW, IF ECHO IS THINKING
ABOUT HAVING SOME POLICIES AND
PRACTICES RELATED TO REPORTBACK,
WHAT'S THE BALANCE BETWEEN
CENTRALIZED RESOURCE AND LOCAL
CONTEXT?
>>I THINK YOU HIT IT EXACTLY.
IT'S BALANCE, RIGHT?
I THINK ONE OF THE OTHER
CHALLENGES IS THAT BECAUSE OF
THE WAY ECHO IS ORGANIZED,
YOU'RE NOT GOING TO HAVE
EXPERTS.
IT REALLY IS -- I SHOULD STEP
BACK AND SAY, IT'S SUPER
IMPORTANT THAT THE COHORT IS THE
ONE COMMUNICATING THE RESULTS.
SO THE RESULTS CAN'T COME FROM
SOME CENTRAL PLACE WHERE THERE'S
NO CONNECTION.
I THINK THE CONNECTION IS REALLY
IMPORTANT.
THAT SAID, IT'S NOT LIKE EVERY
COHORT IS GOING TO HAVE A PER
FLUORINATED EXPERTS OR AN EXPERT
IN EVERY SINGLE ASPECT, SO I
THINK HAVING SOME SORT OF
CENTRALIZED RESOURCE BECOMES
REALLY IMPORTANT WHETHER IT TO
TRAIN THE FOLKS WHO ARE OUT,
GIVING THEM THE INFORMATION AND
THE CONFIDENCE TO BE ABLE TO GO
OUT AND COMMUNICATE THOSE
RESULTS.
AND THE SORT OF CENTRALIZED
RESOURCES BECAUSE IT DOESN'T
REALLY MAKE SENSE FOR 50
DIFFERENT GROUPS TO BE
DEVELOPING THE SAME INFOGRAPHIC
OR THE SAME STORY, RIGHT?
THERE'S EFFICIENCY IN THE THINGS
THAT WE CAN SHARE.
HOWEVER, THERE ARE THINGS THAT
ARE CONTEXT-SPECIFIC, SO HAVING
ENOUGH SPACES WHERE CAN YOU DO
THE ADAPTATIONS THAT ARE GOING
TO MAKE SENSE FOR THE LOCAL
CONTEXT BECOMES IMPORTANT, AND
I'VE BECOME AWARE THAT
ESPECIALLY IN TERMS OF SPANISH
TRANSLATION, SO WHEN I TALK TO
MY FRIENDS WHO HAVE COHORT ON
THE WEST COAST AND THINGS ARE
TRANSLATED INTO MEXICAN SPANISH,
THAT'S NOT ALWAYS UNDERSTANDABLE
TO THE PEOPLE WHO ARE ON THE
EAST COAST SPEAKING CARIBBEAN
SPANISH.
AND SO THESE SORTS OF SPACES TO
BE ABLE TO ADAPT TO THE CONTEXT
THAT THE COHORT IS GOING TO
UNDERSTAND, I THINK IS CRITICAL.
BUT THERE IS -- I THINK THERE IS
A BALANCE, AND IT'S NOT
EVERYONE'S GOT DO IT ON THEIR
OWN OR EVERYTHING IS
CENTRALIZED.
I THINK THERE'S SOME -- YOU
KNOW, THERE'S SOME SPACE IN
BETWEEN THAT AND TRYING TO
FIGURE OUT WHAT IT -- YOU KNOW,
WHERE THAT IS.
>>YES, MONICA.
>>THANK YOU FOR YOUR TALK.
I JUST WANT TO ACKNOWLEDGE THE
PARTNERSHIPS FOR PUBLIC
ENVIRONMENTAL HEALTH HAS LIKE A
REPOSITORY, LIKE THEY COLLECT
INFORMATION DONE ACROSS THE
PROGRAMS, AND SO IT COULD BE AN
INTERESTING MODEL TO LOOK AT.
>>THAT'S A REALLY GOOD POINT
AND I THINK ACTUALLY
SOMETHING -- IT REMINDED ME OF
SOMETHING THAT I WAS GOING TO
SAY EARLIER IS THAT WHEN WE'RE
TALKING ABOUT HOW TO GET
CLINICIANS ENGAGED, BECAUSE A
LOT OF THEM, I THINK ONE OF THE
THINGS WE LEARNED ON OUR PANEL
WAS THAT PEOPLE SAID, OH, IT'S
THE CLINICIANS, BRING YOUR
REPORT TO THE CLINICIANS AND THE
CLINICIANS ON THE CALL ARE LIKE
DON'T BRING TO ME, I DON'T KNOW
WHAT TO SAY, ABOUT THESE
EMERGING CHEMICALS AND THINGS.
BUT ONE RESOURCE THAT I THINK IS
REALLY VALUABLE FOR ECHO THAT I
DON'T RECALL BEING PART OF THE
ECHO LANDSCAPE SO FAR, ARE THE
PEDIATRIC ENVIRONMENTAL HEALTH
SPECIALTY UNIT, THE PEHSUs,
BUT THE NIEHS RESOURCE WHERE
PHYSICIANS ARE TRAINED
GEOGRAPHICALLY ACROSS THE
COUNTRY TO BE THOSE CENTRALIZED
RESOURCES.
AND IN TERMS OF ENVIRONMENTAL
EXPOSURES, THEY REALLY CAN HELP,
YOU KNOW, BE A SPACE WHERE A
LOCAL CLINICIAN COULD CALL IN
AND BE LIKE, HEY, I'VE GOT A
PATIENT WHO IS SHOWING ME THIS
STUFF I DON'T UNDERSTAND.
AND SO I THINK IF WE COULD TIE
THEM INTO THE PROCESS OF
DEVELOPING A REPORTBACK PROGRAM,
ESPECIALLY AS IT RELATES TO
ENVIRONMENTAL EXPOSURES.
I THINK THAT'S WHAT I'M TALKING
ABOUT, BUT I THINK REPORTBACK
OBVIOUSLY HAS A LOT MORE
IMPLICATIONS WHEN WE TALK ABOUT
ALL OF THESE OTHER THINGS: DIET
DIET, NEURODEVELOPMENT, OTHER
SPACES.
>>ANY OTHER QUESTIONS FROM THE
ROOM?
YES, JANE.
>>HI.
WHEN YOU SPEAK ABOUT GETTING
OTHER CLINICIANS INVOLVED, ARE
YOU WORRIED ABOUT THERE BEING
ANY INFLUENCE ON THE DATA THAT
YOU'VE ALREADY COLLECTED?
>>SO AM I WORRIED ABOUT THE --
>>THEM GIVING THEIR INPUT ON
THE DATA THAT THEY RECEIVED FROM
THE PATIENT BASED OFF THEIR
REPORT THAT THE PATIENT
RECEIVED?
>>SO GETTING TO EARLIER YOU'RE
ASKING A LITTLE BIT ABOUT LIKE
WHAT HAPPENS IF YOU GET ADVICE
AND YOU CHANGE YOUR BEHAVIORS,
IS THAT GOING TO INFLUENCE MY
RESEARCH?
IS THAT WHAT YOU'RE ASKING
ABOUT?
I WANT TO MAKE SURE I
UNDERSTAND.
>>NO, FROM THE CLINICIANS, THEM
BEING ABLE TO ACCESS THE
INFORMATION, I KNOW THEY WON'T
HAVE COMPLETE CONTROL OVER THAT
INFORMATION, TO CHANGE ANYTHING
THAT'S INSIDE THAT REPORT
ALREADY, BUT IF THEY ADD A NOTE
OR, LIKE, IF THEY MAKE A
SUGGESTION TO THE PATIENT, CAN
THAT AFFECT YOUR INFORMATION
THAT YOU'VE BEEN ACCUMULATING
OVER THE YEARS?
>>YEAH, SO I THINK THAT WE
DON'T -- I THINK AT LEAST IN
NEW YORK, I DON'T KNOW HOW IT IS
ELSEWHERE, WE DON'T HAVE -- IT'S
NOT LIKE WE CAN PUT THE REPORT
INTO SOMEONE'S MEDICAL RECORD
AND THEN THE -- A DOCTOR COULD
ACCESS IT.
YOU KNOW, THE PARTICIPANT WOULD
REALLY NEED TO TAKE THE REPORT
AND BRING TO THEIR DOCTOR AND
SAY HEY, HERE IT IS, CAN YOU
HELP ME UNDERSTAND THIS?
AND THEN I THINK THE PEDIATRIC
HEALTH SPECIALTY UNIT HUBS
ESSENTIALLY CAN HELP IF YOU GO
TO A DOCTOR WHO DOESN'T HAVE
FAMILIARITY WITH THE SORTS OF
THINGS THAT ARE IN THE REPORT,
THEN THE PEDIATRIC HEALTH
SPECIALTY UNIT HUBS COULD BE THE
ONES WHO THEY GO TO ASK THE --
TO SORT OF GET MORE CLARITY TO
GET MORE INFORMATION THAT
HOPEFULLY THEN GETS RELAYED BACK
TO THE PARTICIPANT.
YOU KNOW, I ALSO AM SORT OF THE
BELIEF THAT IT'S NOT JUST THE
CLINICIANS THAT ARE RESPONSIBLE
FOR MO PROVIDING INFORMATION
ABOUT THIS.
I THINK AS RESEARCHERS, AND
HEALTH WORKERS, RESEARCH STAFF,
WE CAN DO A LOT OF THAT BECAUSE
WE HAVE A LOT MORE INFORMATION
IN SOME CASES THAN THE CLINICAL
PROVIDERS WHO IN MEDICAL SCHOOL
UP TO THIS POINT AREN'T REALLY
TRAINED IN THE SAME KIND OF WAY.
SO WE CAN PREPARE OURSELVES A
LITTLE BIT BETTER TO SORT OF BE
A RESOURCE AS WELL, I THINK.
DID THAT ANSWER YOUR QUESTION?
OKAY, GOOD.
>>THAT QUESTION AND RESPONSE IS
A GREAT SEGUE TO OUR PARTICIPANT
PANEL CHAIRED BY JOHNNYE LEWIS.
SO WE'D LIKE TO BRING FORWARD
OUR ECHO PARTICIPANTS.
AS WELL.
EMILY, PAMELA, JADINE AND
VIVAINNETE.
WE'RE SO GRATEFUL TO HAVE YOU
SHARE IN OUR EXPERIENCE AND ADD
TO OUR LEARNING IN THE ECHO
PROGRAM.
>>I ARGUABLY HAVE THE MOST
FUN PART OF THIS AND HAVE HAD
SUCH A GREAT EXPERIENCE TALKING
WITH EVERYBODY ON THIS PANEL,
AND I THINK A LOT OF THE ISSUES
THAT CAME UP ARE THINGS THAT
HAVE COME UP ACROSS THE GROUP IN
OUR CHANCES TO TALK WITH EACH
OTHER BEFORE, SO I THINK A LOT
OF THE INTRODUCTION I WAS GOING
TO DO HAS ALREADY HAPPENED, BUT
WHAT I WOULD LIKE TO START WITH
IS HAVING EACH OF THE PANELISTS
DO JUST A COUPLE-MINUTE
INTRODUCTION OF THE COHORT THAT
THEY'RE WITH, HOW LONG THEY'VE
BEEN THERE, AND WHY THEY JOINED,
BECAUSE I THINK THAT WILL REALLY
HELP EVERYBODY UNDERSTAND THE
PERSPECTIVES THAT ARE SITTING
HERE AT THE TABLE AND THE REALLY
GREAT WEALTH OF KNOWLEDGE THAT'S
HERE.
PAMELA, DO YOU WANT TO START?
>>I'M GOING TO FORMALLY
INTRODUCE MYSELF.
[SPEAKING FOREIGN LANGUAGE]
JUST SAYING THAT I AM THE
MEXICAN PEOPLE -- FOR THE RED
BOTTOM PEOPLE.
MY PATERNAL GRANDPARENTS ARE THE
COYOTE PAS CLAN, MY MATERNAL
GRANDPARENTS ARE THE NEAR THE
WATER CLAN.
I AM 39 YEARS OLD.
I AM A MOTHER OF FOUR KIDS AND I
AM A PARTICIPANT OF THE NAVAJO
NATION BIRTH COHORT PROGRAM.
AS A PARTICIPANT, THE REASON WHY
I JOINED THE STUDY IS I AM A
CURRENT EMPLOYEE OF THE WOMEN'S
HEALTH CLINIC AT THE LOCAL IHS
IN CHIN LEE AND SINCE 2014, WHEN
ECHO CAME INTO OUR CLINICS, IT
REALLY -- I REALLY SHOWED A LOT
OF INTEREST BECAUSE I WOULD LOOK
AT THE PAMPHLETS AND THE
QUESTIONNAIRES AND THE CONSENTS
AND STUFF TO BE ABLE TO HELP THE
PROGRAM RECRUIT MORE AND MORE
PATIENTS.
IN THAT INSTANCE, I SHOWED A LOT
OF INTEREST IN IT.
BUT I WASN'T -- LIKE I HAD
SEVERAL MISCARRIAGES AS I HAD
MENTIONED BEFORE, AND THEN
FINALLY I HAD MY MIRACLE BABY,
MY RAINBOW BABY, WHICH IS
PAISLEY, WHO IS 3 YEARS OLD.
ALONG WITH THAT, I WAS DIAGNOSED
WITH -- DURING MY PREGNANCY AT
27 WEEKS, PRENATAL, I WAS
DIAGNOSED WITH STAGE IIIB
CERVICAL CANCER, AND A SPREAD TO
THE LYMPH NODES.
PAISLEY WAS BORN AT 31 WEEKS,
AND SHE DID SUFFER SOME
RESPIRATORY FAILURE AFTER SHE
WAS BORN.
SHE WAS IN THE NICU FOR FOUR
WEEKS AND SINCE I DID NOT WANT
TO LEAVE HER SIDE, SO I DIDN'T
START TREATMENTS UNTIL SHE WAS .
FOR ME, I WOULD REALLY LIKE TO
TAKE RAPPORT BACK TO MY
COMMUNITIES, BECAUSE OVER THE
PAST SIX MONTHS IN MY CLINICS, I
HAVE BEEN ACTUALLY SITTING IN AS
THE CLINICAL CASE MANAGER.
BEING IN THAT POSITION PUT ME IN
A POSITION TO OVERSEE WHAT OUR
PATIENTS DO GO THROUGH IN OUR
COMMUNITIES, WHETHER OR NOT
THEY'RE PRENATAL, BUT THE
EFFECTS THAT OUR PATIENTS DO GO
THROUGH IN OUR COMMUNITY AND,
YOU KNOW, I WASN'T AWARE OF ALL
OF THIS UNTIL I ACTUALLY SAT IN
THAT POSITION MYSELF.
SO THAT'S WHY I SHOWED INTEREST
IN THE PROGRAM AND I'M VERY
GRATEFUL FOR ALL THE REFERRALS
AND THE SUPPORT THAT WE DO
RECEIVE FROM OUR SPECIALISTS IN
CHIN LEE.
I'LL GO AHEAD AND LET JADINE GO.
>>HI.
MY NAME IS JADINE BENJAMIN.
I AM 20 YEARS OLD AND I ATTEND
NORTH CAROLINA CENTRAL
UNIVERSITY IN DURHAM, NORTH
CAROLINA.
GO EAGLES!
I AM ALSO A NAIL TECH ON THE
SIDE.
I DO MY NAILS.
I WAS ACTUALLY BORN INTO THE
ELGANS COHORT STUDY.
IT BEEN GOING ON, I BELIEVE
SINCE I WAS BORN, A LITTLE BIT
BEFORE.
MY INTEREST IN THIS IS TO KNOW
WHAT I'VE CONTRIBUTED TO THIS
STUDY AND HOW I CAN USE THIS
INFORMATION IN MAYBE MY OWN
CLINICAL TRIAL.
AND I THINK THAT I LIKE TO
DISCOVER HOW ELSE I CAN
CONTRIBUTE TO OTHER STUDIES IN
RESEARCH IN GENERAL.
THANK YOU.
>>HI, Y'ALL.
MY NAME IS VIVAINNETE PEREZ.
I'M FROM PUERTO RICO, I'M 33
YEARS OLD, AND I HAVE TWO KIDS.
THE ELDEST IS 14 AND MY LITTLE
ONE IS 6.
I PARTICIPATE IN THE PROGRAM IN
2016 BECAUSE I WAS CONCERNED
ABOUT THE -- PRETERM BIRTH -- IN
PUERTO RICO BECAUSE IT WAS ONE
OF THE MOST COUNTRY WITH THAT
ISSUE, SO --
[SPEAKING FOREIGN LANGUAGE]
>>WHAT SHE'S SAYING IS THAT SHE
JOINED THE STUDY BECAUSE SHE WAS
INTERESTED IN KNOWING ABOUT
PRETERM BIRTH.
PORT RPORTICO PUERTO RICO HAD SD
IN PRETERM BIRTHS, SHE WANTED TO
KNOW THE CAUSE, ENVIRONMENTAL OR
SOMETHING ELSE, AND TO BE ABLE
TO CONTRIBUTE TO THIS AND TO
UNDERSTAND FOR THEMSELVES.
[SPEAKING FOREIGN LANGUAGE]
>>HER BIRTHS WERE NOT
PREMATURE, HER CHILDREN WERE NOT
PREMATURE, BUT THE INFORMATION,
THE REPORTBACK HELPED HER TO
MAKE DECISIONS IN THE FUTURE.
>>THANK YOU.
>>HI, I'M EMILY MONROE.
I'M IN THE NEW HAMPSHIRE BIRTH
COHORT STUDY.
I'VE BEEN IN SINCE 2017, WHEN MY
FIRST WAS BORN.
AND I HAVE FOUR KIDS THAT ARE
ACTIVELY ENROLLED AND ONE THAT
WE'RE GATHERING DATA TO 22 WEEKS
RIGHT NOW.
THE REASON I JOINED WAS THAT
THEY BASICALLY PROMISED WATER
QUALITY INFORMATION AND I GREW
UP -- I'M THE DAUGHTER OF A
CAREER MARINE SO I ACTUALLY DID
SOME TIME ACROSS THE RIVER IN
NORTHERN VIRGINIA, AND HAD NEVER
LIVED ON WELL WATER BEFORE I
MOVED TO NEW HAMPSHIRE, SO I
JUST WANTED TO KNOW, WHAT AM I
POTENTIALLY DOING TO MY FAMILY,
LIVING OUT IN RURAL
NEW HAMPSHIRE.
AND SO THE INFORMATION THAT I'VE
GOTTEN HAS JUST MADE ME FEEL A
LOT MORE CONFIDENT, RAISING MY
FAMILY IN THAT ENVIRONMENT, AND
WE'VE GOTTEN BACK WATER RESULTS,
AIR QUALITY RESULTS AND THINGS
THAT JUST GENERALLY MAKE ME FEEL
REALLY GREAT ABOUT WHERE I LIVE
AND THAT'S PART OF WHY I
CONTINUE TO PARTICIPATE.
I ASKED MY KIDS WHY DO YOU LIKE
TO PARTICIPATE BECAUSE THEY'VE
EACH DONE ONE OF THOSE, LIKE --
THE VEST WITH THE AIR QUALITY
MONITOR THAT'S KIND OF
INTERESTING FOR THEM AND THEY
THANK YOU FOR THE SUPPLEMENTARY
GIFT CARDS BECAUSE THEY CAN BUY
TOYS.
SO THEY ARE MOTIVATED TO
CONTINUE TO PARTICIPATE.
>>SO I THINK A LOT OF THE
THINGS THAT WE'VE BEEN TALKING
ABOUT TODAY ARE PROBABLY GOING
TO COME OUT IN THE PANEL, AND
WHAT WE'RE GOING TO DO IS WE
HAVE FOUR EXAMPLES OF THINGS
THAT ARE HOPEFULLY COVERING A
LITTLE BIT OF THE BREADTH IN
ECHO, AND WE'LL ROTATE THROUGH A
SERIES OF QUESTIONS THAT HAVE
ACTUALLY COME FROM THE
ORGANIZERS AND FROM OUR
DISCUSSIONS, AND GIVE EVERYBODY
A CHANCE TO SORT OF LEAD OFF
THAT DISCUSSION AND ASK THEM ALL
ALSO TO CONTRIBUTE ANYTHING THEY
FEEL WAS LEFT OUT ALONG THE WAY,
AND THEN HOPEFULLY WE'LL HAVE
TIME FOR QUESTIONS AT THE END OF
THAT THEN.
AND SO THE FIRST ONE, AND THESE
ARE EXAMPLES OF CATEGORIES OF
RESULTS.
WE TALK A LOT ABOUT
BIOMONITORRING, BUT ECHO AS
YOU'VE SEEN IS SO BROAD, AND
THERE ARE SO MANY RESULTS.
I MEAN, I CAN'T FORESEE A TIME
THAT EVERYTHING WILL GO BACK OR
THAT ANYBODY WOULD WANT THAT.
BUT THIS IS TO TRY AND FOCUS OUR
THINKING AROUND JUST A FEW
DIFFERENT EXAMPLES OF CATEGORIES
THAT WE MIGHT HAVE.
SO THE FIRST ONE, YOU RECEIVE A
LETTER THAT THE CHEMICAL BPA
THAT WAS DETECTED IN YOUR URINE
WAS VERY HIGH.
THE LETTER ALSO INDICATES THAT
THIS IS A CHEMICAL THAT'S FOUND
IN THE LINING -- EITHER IN THE
LINING OR OF MANY FOOD AND
BEVERAGE CONTAINERS.
AND I WANT TO START THIS OFF
WITH VIVAINNETE, SAYING WHAT
WOULD YOUR PERSONAL REACTION BE
TO RECEIVING THESE RESULTS AND
FOR ALL THE PANELIST, WE CAN
THINK ABOUT THIS AS ANY CHEMICAL
CONTAMINANT AND I THINK A LOT OF
THE SAME RESPONSES WILL APPLY.
SO WHAT WOULD BE YOUR PERSONAL
REACTION, FEAR, WORRY, LITTLE OR
NO CONCERN, AND WHAT IMMEDIATE
QUESTIONS WOULD YOU WANT
ANSWERED IN THAT INFORMATION IN
ORDER TO UNDERSTAND AND PLAN HOW
TO ADDRESS THOSE RESULTS?
>>YES.
FIRST I FEEL CONCERN, AND THEN I
WILL ASK SO MANY QUESTIONS ABOUT
IT.
LIKE HOW CAN I GET EXPOSED IF
BPA OR SOME CONTAMINANT HAVE
SOME EFFECT ON ME OR MY FAMILY,
AND WHAT CAN I DO TO REDUCE IT.
THAT, MAYBE I WANT FEEDBACK TO
GET OPTIONS.
>>THANK YOU.
AND PAMELA, HOW WOULD YOU WANT
THOSE RESULTS TO BE COMPARED IN
ORDER TO BETTER UNDERSTAND THEM?
WOULD YOU LIKE THEM COMPARED
WITH YOUR COHORT, WITH THE WHOLE
ECHO COHORT, WITH SOME NATIONAL
DATASET?
WHAT WOULD BE THE MOST IMPORTANT
THING FOR YOU?
>>I THINK THE DATA THAT I WOULD
LIKE TO GET REPORTBACK ON WOULD
PROBABLY BE WITHIN MY COMMUNITY
AS A WHOLE, AND THEN WITHIN THE
PARTICIPANTS IN OUR STUDY OR NOT
EVEN JUST MY COMMUNITY BUT
NAVAJO NATIONWIDE, BECAUSE THAT
WILL SET US ON A LEVEL OF WHERE
I WON'T SAY NORM BUT A
STANDARDIZED EXPOSURE WOULD BE
MORE RELEVANT IN THAT MANNER.
AND THEN AS I HAD MENTIONED
BEFORE, IN OUR COMMUNITIES LIKE
ONE OF THE PRESENTERS HAD
MENTIONED THAT I COULD HONESTLY
SAY PROBABLY ABOUT 10% OF THE
NAVAJO NATION POPULATION DO NOT
HAVE A HIGH SCHOOL DIPLOMA OR
DIDN'T FINISH HIGH SCHOOL, IT
WOULD BE NICE, AND THEN TO HAVE
THEM LIKE IN A GRAPH FORM OR
EVEN THROUGH SOCIAL MEDIA, THE
YOUTUBE VIDEOS, I THINK ARE WHAT
REALLY ATTRACT A LOT OF THE
YOUNGER POPULATION NOW.
>>AND ONE OF THE THINGS I JUST
WANTED TO EMPHASIZE, AND THIS
CAME OUT IN SOME OF OUR PLANNING
MEETINGS, AND WAS ALSO BROUGHT
UP IN REFERENCE TO SOMETHING
ELSE WAS THAT ABILITY TO LOOK AT
THAT COMMUNITY RELATIVE TO A
NATIONAL DATASET SO THAT THERE
IS THAT OPPORTUNITY OF FINDING
SOMETHING THAT MAY BE UNUSUALLY
HIGH THERE.
AND THAT WAS BROUGHT UP BY
SEVERAL OF THE PARTICIPANTS IN
OUR PREVIOUS DISCUSSIONS, AND I
DON'T THINK WE THINK ABOUT THAT
A LOT OF TIMES, AND THAT'S VERY
IMPORTANT.
EMILY, WHAT WOULD YOU CHANGE IF
ANYTHING AS A RESULT OF GETTING
INFORMATION LIKE THIS?
AND WHAT ADDITIONAL INFORMATION
WOULD YOU WANT IN ORDER TO MAKE
THAT DECISION AN EFFECTIVE ONE?
AND WHAT BARRIERS MIGHT YOU SEE
TO BEING ABLE TO MAKE THE
CHANGES YOU WOULD LIKE TO?
>>SO I THINK IN THE CONTEXT OF
BPA, WE HAD SAID THIS WAS
PRESENTED IN ADDITION TO SAYING
A LOT OF BPA CAN COME FROM HOW
YOUR FOOD IS PACKAGED.
AND I WOULD WANT TO HAVE
SPECIFIC EXAMPLES OF AVOID THIS,
IF YOU HAVE BEEN BUYING FOOD IN
PLASTIC, AVOID THIS KIND OF
PLASTIC, OR YOU KNOW, IF YOU ARE
ABLE TO, ORGANIC FOOD IS
HELPFUL, OPT FOR THAT.
I THINK THE MOST HELPFUL THING
WOULD BE TO HAVE SOME AMOUNT OF
HELPFUL NEXT STEPS, AND EVEN IF
IT'S NOT COMING FROM LIKE A
WEBSITE THAT THE BIRTH COHORT
I'M FAMILIAR WITH, YOU KNOW,
SUPPORTS, IF IT'S SOMETHING THAT
IT'S COMING FROM MY BIRTH
COHORT, IT HAS AUTHORITY, IT
HAS -- LIKE THAT WORD OF MOUTH
RECOMMENDATION, AND I WOULD GO
TO THAT SOURCE FIRST.
TO SEE WHAT DO I DO, WHAT DO I
DO NEXT, HOW DO I HELP IT.
AND I THINK ALSO JUST
RECOGNIZING, I DON'T EXPECT
THIS -- I DON'T EXPECT THE
RESEARCHERS TO HAVE ALL THE
ANSWERS EITHER, I KNOW THAT'S
COME UP A FEW TIMES, BUT JUST
KNOWING THAT THERE IS AN
EXPOSURE RISK OR KNOWING WHAT
SOME OF THE MAIN SOURCES WERE,
IT'S JUST HELPFUL.
AND THEN I CAN MAKE MY OWN
DECISIONS OF WHAT CAN I AFFORD,
WHAT'S BEST FOR MY FAMILY,
WHAT'S EVEN ACHIEVABLE IN THE
PLACE WHERE I LIVE WHERE THERE'S
JUST ONE GROCERY STORE WITHIN 30
MINUTES.
>>DID ANYBODY ELSE WANT TO ADD
TO THAT POINT ABOUT THE
BARRIERS?
BECAUSE I KNOW THAT CAME UP A
LOT IN OUR CONVERSATIONS AS
WELL, THAT WE'RE LOOKING AT
RURAL POPULATIONS OFTEN WHERE
THERE'S SOMETIMES LIMITED ACCESS
TO FOOD SOURCES AND VIVAINNETE,
I THINK YOU HAD --
>>
[SPEAKING FOREIGN LANGUAGE]
>>HAVING ACCESS TO A VARIETY OF
PRODUCTS THAT ARE BETTER AND
LIVING ON AN ISLAND IS MORE
DIFFICULT.
SO I WOULD LIKE TO KNOW IN TERMS
OF WHAT I CAN DO SPECIFICALLY,
WHAT I SHOULD AVOID, WHAT I CAN
SUBSTITUTE AND USE IN ORDER TO
REDUCE EXPOSURE.
>>JADINE, DO YOU WANT TO TALK A
LITTLE BIT ABOUT THE KIND OF --
THE FORMAT THAT WOULD BE MOST
USEFUL FOR YOU IN UNDERSTANDING
THIS INFORMATION, AND JUST TAKE
IT FROM THERE.
>>YES.
I FEEL THAT FOR ME PERSONALLY, I
WOULD PREFER TO HAVE A WEBSITE,
SOMETHING THAT I CAN GO AND LOOK
AT AND HAVE A SELECTION OF
INFORMATION THAT I CAN HAVE
ACCESS TO, AND IT WOULD BE IN
DEPTH AND I CAN READ ARTICLES,
THINGS THAT CAN HELP ME TO
CONNECT INFORMATION THAT I'M
RECEIVING FROM YOU GUYS.
I ALSO THINK THAT HAVING A
PHYSICAL COPY OF THE WEBSITE,
LIKE A NEWSLETTER, A PACKET,
SOMETHING LIKE THAT WITH THE
GRAPHS INCLUDED, I THINK THAT
WILL HELP PEOPLE WHO ARE NOT
TECH-SAVVY.
AND GOING OFF OF WHAT PAMELA
SAID, I THINK THAT VIDEOS ALSO
HELP AS WELL, BECAUSE NOT
EVERYONE HAS ACCESS TO INTERNET
AND, YOU KNOW, MAIL SYSTEM IS
CRAZY THESE DAYS, SO I THINK
THAT HAVING A VIDEO OR SOMETHING
THAT, YOU KNOW, THEY CAN HAVE
MULTIPLE ROUTES OF ACCESS TO,
YOU KNOW, WOULD BE BENEFICIAL TO
DIFFERENT KINDS OF
PERSONALITIES.
BECAUSE WE'RE NOT JUST LOOKING
AT HOW PEOPLE ARE GOING TO GET
THE INFORMATION, WE'RE LOOKING
AT HOW THEY ARE GOING TO RECEIVE
IT.
AND NOT JUST IN THE PHYSICAL
FOMPLFORM, BUT MENTALLY, HOW CAU
HELP US UNDERSTAND.
THANK YOU.
>>PUN INTENDED, I WANT TO ECHO
WHAT JADINE IS SAYING.
I THINK IT'S COME UP A FEW
TIMES, IT WOULD BE REALLY NICE
TO HAVE JUST A WEBSITE THAT HAS
RESOURCES THAT WE CAN GO TO.
IF YOU'VE GOTTEN THESE RESULTS
BACK, GO HERE.
AND I THINK IT CAN FEEL
BURDENSOME, LIKE WE'RE ASKING
FOR A LOT OF INFORMATION, BUT I
THINK YOU COULD ALSO USE US
MORE, SO LIKE FILM THOSE INFO
SESSIONS, RIGHT, WHERE YOU'RE
SAYING THE AUTHORITY AND THEN
GETTING THE QUESTIONS, THE Q &
A, AND THAT BECOMES YOUR
FREQUENTLY ASKED QUESTIONS
RESOURCE, RIGHT?
AND THEN IT'S NO MORE EFFORT
THAN YOU'VE ALREADY DONE.
AND SO I JUST WANT TO SAY, I
WOULD LIKE TO GO BACK AND
REFERENCE MORE OF NOT JUST, OH,
I GOT THIS INDIVIDUAL RESULT AND
THEN TWO YEARS LATER WITH MY
NEXT BABY I GOT THIS INDIVIDUAL
RESULT.
I'D LOVE TO BE ABLE TO COMPARE
THEM AND I JUST DON'T KEEP ALL
THE PAPERS, BUT LIKE TO HAVE
SOMETHING THAT WAS AN ONLINE
RESOURCE THAT'S THERE, I WOULD
ABSOLUTELY USE THAT.
>>EXCELLENT.
I'M GOING TO MOVE ON TO THE NEXT
ONE AND THEN WE'LL COME BACK TO
A COUPLE OF POINTS AT THE END.
SO THE NEXT QUESTION HAS MORE TO
DO WITH SOMETHING MORE ON THE
LINE OF A CLINICAL RESULT.
SO YOU RECEIVE A LETTER TELLING
YOU THAT A SCREENING OF YOUR
VERY YOUNG CHILD HAS SHOWNED
SOME SPECIFIC DEVELOPMENTAL
CATEGORIES WHERE YOUR CHILD WAS
UNDERPERFORMING CERTAIN
BENCHMARKS.
LETTERS SUGGEST THAT THERE ARE
SOME EARLY INTERVENTION SERVICES
THAT MIGHT HELP SO THAT YOUR
CHILD CAN CATCH UP, AND GIVES
YOU A REFERRAL TO ONE OF THOSE
PROGRAMS.
SO PAMELA, IF WE CAN START WITH
YOU ON THIS ONE, WHAT WOULD BE
YOUR PERSONAL REACTION TO
RECEIVING THOSE RESULTS, AND
WHAT WOULD BE AGAIN YOUR
IMMEDIATE QUESTIONS?
>>OKAY.
WELL, FORTUNATELY FOR THIS
QUESTION, I DID GET -- I DID GET
A LETTER STATING THAT PAISLEY
WAS DEVELOPMENTALLY DELAYED, AND
AT THAT POINT, JUST A -- FROM
THE CULTURAL ASPECT, WE'RE LIKE
OH, NO, SHE'S JUST CATCHING UP
WITH EVERYBODY, SHE WAS
PREMATURE, BUT WE DID START TO
NOTICE SENSORY ISSUES, WHICH
PERTAINED TO ACUTE AUTISM, AND
THEN ALONG THE LINES OF HER NOT
WALKING AT THE SAME TIME AS HER
AGE GROUP, SHE WAS STILL
UNBALANCED AND SO WITH THAT
SAID, I HAD A LOT OF QUESTIONS
BECAUSE I WAS THINKING WAS IT
SOMETHING THAT I DID, OR WAS IT
JUST BECAUSE SHE WAS PREMATURE,
AND THEN IN THAT SENSE, I
THOUGHT THAT, OKAY, I GOT THIS
LETTER FROM, YOU KNOW, ECHO,
FROM OUR EVALUATION, IS THERE
ANYTHING THAT YOU GUYS CAN GIVE
ME AS FAR AS FEEDBACK OR RAPPORT
ON IF WE WERE EXPOSED TO
ANYTHING, FOR INSTANCE, LIKE I
SAID I'VE HAD MY MOTHER WHO
PASSED AWAY FROM CANCER, MY
GRANDPA WHO PASSED AWAY FROM
CANCER BUT WE WERE IN EVERY,
EVER SPECIFIED ON IF WE WERE
EXPOSED TO URANIUM BECAUSE WE
ALL STILL LIVE IN THE SAME AREA.
THERE ARE OTHER INSTANCES AS FAR
AS OUR HEALTH FOR MY DAUGHTER
AND MYSELF AND THIS IS ALL VERY,
VERY NEW, WITHIN THE LAST SIX
YEARS FOR US.
SO IN THAT SENSE, I WAS VERY
FORTUNATE THAT MY BIRTH COHORT
PROGRAM CAME BACK AND OFFERED A
REFERRAL TO EARLY CHILDHOOD
INTERVENTION.
PAISLEY DID GRADUATE FROM A
LOCAL FACE PROGRAM AND SHE IS
CURRENTLY IN PRESCHOOL AND IS
NOT YET AT HER CLASS BUT SHE'S
WALKING ALL ON HER OWN NOW,
SHE'S RIDING A BIKE, SHE EVEN
RIDES A LITTLE SCOOTER AROUND,
AND THEN SHE TALKS TOO MUCH NOW.
BEFORE SHE WAS NON-VERBAL.
BUT NOW SHE WANTS TO REPEAT
EVERYTHING EVERYBODY SAYS.
SO IN THAT SENSE, WE ARE VERY
FORTUNATE AND GRATEFUL THAT THE
BIRTH COHORT PROGRAM HAD GIVEN
US THOSE RESOURCES BECAUSE
OTHERWISE WE WOULD HAVE BEEN
REACHING OUT FOR THOSE SERVICES
ON OUR OWN AND THEN IT WOULD
HAVE BEEN OUT OF POCKET PAY.
BECAUSE WE WERE ALL THE WAY UP
TO PHILADELPHIA FOR -- AS FAR AS
HER AUTISM STUFF, WHICH IS
AMAZING.
>>VIVAINNETE, IF YOU HAD
RESULTS LIKE THAT, WHAT WOULD
YOU LIKE FOR HOW THEY'RE
COMPARED, SO SORT OF THE SAME
QUESTION WE HAD FOR THE CHEMICAL
RESULTS BUT NOW WITH A MEDICAL
CONTEXT?
>>
[SPEAKING FOREIGN LANGUAGE]
>>JUST A SECOND SO I CAN START.
NOW I'M GOING TO FORGET.
FIRST I WOULD LIKE TO KNOW WHAT
IS THE STANDARD FOR DEVELOPMENT
AT THAT MOMENT.
I WOULD ALSO LIKE TO RECEIVE THE
INFORMATION IN A FORMAT THAT I
COULD UNDERSTAND AND I CAN TAKE
TO A CLINICIAN.
TO GET MORE HELP.
AND WHAT RESOURCES ARE AVAILABLE
SO THAT I CAN HELP MY CHILD.
>>JADINE, IF YOU RECEIVED A
REFERRAL, AND I KNOW YOU DON'T
HAVE A CHILD YET, BUT IF THIS
CAME FOR YOU WITH A REFERRAL,
WOULD YOU TAKE ADVANTAGE OF THAT
REFERRAL AND CAN YOU THINK OF
SOME BARRIERS THAT MIGHT MAKE
YOU NOT WANT TO GO TO TAKE
ADVANTAGE OF THE CLINICAL
REFERRAL?
>>YES, AS YOU STATED, I DON'T
HAVE ANY KIDS.
THEY SEEM LIKE A LOT OF WORK.
SO IF I WERE TO BE A PARENT, I
WOULD WANT TO TAKE ADVANTAGE OF
THAT REFERRAL BECAUSE AT THAT
POINT, IT WOULD BE THE ONLY
SOURCE OF HELP THAT I HAVE
OUTSIDE OF THE STUDY.
SO I WOULD TAKE ADVANTAGE OF
THAT, BUT BARRIERS THAT I CAN
SEE IS, YOU KNOW, THE POTENTIAL
OF THAT NOT WORKING OUT AND
YOU'D COME BACK TO SQUARE ONE
WITH NEEDING ANOTHER REFERRAL OR
ANOTHER SOURCE OF INFORMATION TO
HELP, SO I WOULD SAY THE BARRIER
WOULD BE GETTING STUCK AT THE
SAME SPOT THAT YOU STARTED, SO I
WOULD SAY OR SUGGEST THAT, YOU
KNOW, HAVE MULTIPLE REFERRALS IF
YOU CAN, OR OBVIOUS ONES WOULD
BE LIKE TRANSPORTATION AND
FUNDING, WHETHER IT'S COMING OUT
OF THE POCKET PERSONALLY OR IF
IT'S, YOU KNOW, JUST A MATTER OF
HOW MUCH MONEY YOU NEED FOR THE
WHOLE THING TO, YOU KNOW, WORK
AND BE SMOOTH.
OUTSIDE OF THAT, I THINK IT'S A
GOOD THING TO REFER HELP FOR
PARENTS WHO FEEL HELPLESS.
THANK YOU CH
>>AND EMILY.
WHO WOULD YOU WANT TO -- THIS IS
SORT OF SENSITIVE INFORMATION,
AND WHO WOULD YOU WARRANT TO WAO
DELIVER THAT INFORMATION TO YOU
AND WHY?
>>I THINK THE THING I KEEP
COMING BAB TO IS THE PEOPLE THAT
RECRUITED ME INTO THIS STUDY, I
HAVE A FACE ASSOCIATED WITH
THEM.
IF I WOS GET I WAS GETTING DIFF,
I WOULD LOVE TO GET IT FROM
THEM.
WHICH IS NOT WHAT YOU SIGNED UP
FOR AS A RESEARCHER BUT IT IS
JUST SO MUCH MORE HELPFUL TO
CONTEXTUALIZE AND BE ABLE TO ASK
QUESTIONS.
YOU KNOW, WHEN YOU HA GET A LETR
IN THE MAIL THAT HAS BAD NEWS ON
IT IT'S JUST THAT SINKING
FEELING VERSUS IF YOU HAVE
SOMEONE WHO'S DELIVERING THAT
AND A SAYING HERE'S ALL THESE
OTHER THINGS THAT WE CAN DO, YOU
KNOW, WE HAVE THESE SAFETY NETS
HERE TO HELP, IT DOES MAKE IT A
LOT MORE BEARABLE TO GET THAT
NEWS, BUT ALSO YOU'VE TALKED
ABOUT RETENTION.
ABSOLUTELY, I WOULD CONTINUE
COMING BACK TO A STUDY THAT
TREATED ME LIKE A PERSON AND
THAT I KNOW YOU WANT TO HELP ME.
YEAH.
THAT WOULD HELP RETAIN ME FOR
SURE.
>>I LIKE THAT YOU ADDED TO THAT
THAT IT WOULD BE ALONG WITH
OTHER STEPS THAT YOU COULD TAKE
AND OTHER RESOURCES THAT WOULD
BE AVAILABLE.
AND WHEN WE HAD OUR EARLIER
DISCUSSIONS, THIS IS SOMETHING
THAT CAME OUT FROM EVERYBODY.
THE PARTY THAT IS MOST TRUSTED
AT THIS POINT IS THE ACTUAL ONE
ON ONE CONTACT THAT'S BEEN
COLLECTING DATA FOR UP TO 20
YEARS, AND LET PEOPLE KNOW, AND
THEY MAY NOT BE THE CLINICAL
EXPERT, BUT TO HAVE THAT
INTERFACE AND THAT PROCESS OF
CONNECTION WITH OTHER RESOURCES
WAS BROUGHT UP BY EVERYBODY IS
REALLY IMPORTANT.
DOES ANYONE WANT TO ADD TO THAT?
GO AHEAD, JADINE.
>>IN ADDITION, I THINK THAT
BEING -- GIVEN INFORMATION BY
SOMEONE WHO'S TRUSTED, I HAVE A
FACE TO A NAME AS WELL, AND I
APPRECIATE HER GREATLY.
I THINK THAT GETTING INFORMATION
BACK FROM SOMEONE THAT YOU
TRUST, IT HELPS BUILD A GREAT
RELATIONSHIP FIRST AND IT KEEPS
THE PARTICIPANT WANTING TO COME
BACK, AND I ALSO THINK THAT
HAVING SOMEONE GIVE YOU
INFORMATION EVERY TIME THAT YOU
HAVE INFORMATION TO, LIKE, YOU
KNOW, RECEIVE, WHETHER IT'S GOOD
OR BAD, I THINK THAT IT'S BEEN
FICIAL TO THE RELATIONSHIP AND
TO THE STUDY BECAUSE IT BUILDS A
STRONG FOUNDATION OF TRUST THAT
YOU KNOW YOU'RE GOING TO GET
YOUR INFORMATION BACK,
REGARDLESS OF -- IT MAY BE SCARY
TO HEAR OR YOU HAVE SOMEONE THAT
YOU TRUST TO LET THOSE OPINIONS
AND EMOTIONS OUT BASED ON WHAT
INFORMATION YOU'VE BEEN GIVEN.
>>IMPORTANT POINTS.
THANK YOU.
OKAY.
WE'RE MOVING ON TO NOW ONE THAT
IS MORE BEHAVIORAL, AND ON A
VERY INDIVIDUAL LEVEL.
SO YOU RECEIVE RESULTS FROM
SLEEP MONITORING THAT WAS DONE
ON YOUR CHILD OR YOURSELF AND
YOU FIND OUT THE AMOUNT OR
QUALITY OF SLEEP IS WELL BELOW
WHAT RESEARCHERS AND CLINICIANS
RECOMMEND IS NECESSARY.
YOU'RE ALSO GIVEN RESULTS FROM
AN ECHO-WIDE STUDY THAT SHOW
THAT BETTER SLEEP QUALITY IS
LINKED TO LOWER LEVELS OF STRESS
AND BETTER GENERAL HEALTH, AND
HIGHER LEVELS OF SATISFACTION.
SO IN THIS CASE, WHAT WOULD BE
YOUR PERSONAL REACTION?
AND THIS IS FOR JADINE.
AND WHAT WOULD BE YOUR IMMEDIATE
OTHER QUESTIONS THAT YOU WOULD
WANT TO MAKE SURE CAME ALONG
WITH THAT?
>>BEING A COLLEGE STUDENT AND A
FULL TIME WORKER, I AM PRETTY
SURE I MIGHT BE ON THAT
SPECTRUM.
[LAUGHTER]
BUT MY PERSONAL REACTION WOULD
BE, I WOULD BE CURIOUS AS TO
WHAT IS CONSIDERED TO BE NORMAL
IN THE EYES OF ECHO OR, YOU
KNOW, OTHER SURROUNDING COHORTS.
MY QUESTION WOULD BE, IS THIS
JUST BASED OFF OF MY LIFE
EXPERIENCE, LIKE, YOU KNOW,
THINGS THAT I'M ALREADY INVOLVED
IN, OR THIS IS SOMETHING THAT'S
GENETIC, LIKE, YOU KNOW, YOUR
FAMILY IS PREDISPOSED TO LACK OF
SLEEP BECAUSE OF CERTAIN
STRESSORS THAT YOU'VE BEEN
INTRODUCED TO, AND STRESS ORS
ARE GENERATIONAL, SO THINGS YOU
SEE CAN OFTEN BE ADOPTED, SO I
WOULD WANT TO KNOW HOW MUCH DOES
THE ENVIRONMENT HAVE AN EFFECT
ON MY SLEEPING.
YEAH.
I THINK -- DID I ANSWER THE
QUESTION?
OKAY.
>>THAT BROUGHT UP A COUPLE OF
OTHER POINTS IN TERMS OF THE
CONTEXT, AND THINKING ABOUT THAT
WHAT COMMUNITY THINGS GET
COMPARED TO, AND IS IT THE
PHYSICAL COMMUNITY, IS IT THE
LARGER CONTEXT OF SOME
PARTICULAR CATEGORY THAT YOU ARE
PART.
THAT'S GOOD.
EMILY, WHAT WOULD YOU THINK
ABOUT REFERENCE INFORMATION TO
HELP YOU UNDERSTAND THESE
RESULTS?
>>MY THOUGHT WHEN I READ THIS
QUESTION WAS I WOULD LOVE TO SEE
KIND OF WHERE I FALL IN THE
RANGE OF NORMAL, OR MY CHILD,
AND BASICALLY WHERE SHOULD I BE,
YOU KNOW?
I'M PICTURING THIS LINE GRAPH
WHERE IT'S LIKE YOU'RE HERE AND
YOU WANT TO GO HERE, AND THAT
WOULD HELP ME TO KIND OF SEE,
ALL RIGHT, I HAVE A GOAL OF WHAT
I NEED TO MOVE TOWARD, AND
AGAIN, IT WOULD BE GREAT TO GET
SOME RESOURCES TO HELP, LIKE,
HOW DO I GET MORE SLEEP OR HELP
MY CHILDREN GET MORE SLEEP, WHAT
ARE SOME -- BECAUSE I CAN BE
MOTIVATED, RIGHT, BUT BY THE
RESULTS BUT THE TACTICS OF HOW
DO I CHANGE IT WOULD BE REALLY
HELPFUL TO HAVE.
>>AN
>>AND PAMELA, WHAT WOULD YOU
ENVISION CHANGING IF YOU GOT
RESULTS LIKE THIS AND WHAT
ADDITIONAL INFORMATION WOULD YOU
NEED AND, AGAIN, WHAT BARRIERS
MIGHT YOU SEE?
>>I'LL JUST START OFF WITH MY
APPEARANCE TODAY HAS TO DO WITH
MY SLEEP STUDY.
BEING A MOM, AND I DO HAVE MY
OWN -- MY OWN SIDE -- MY OWN
LITTLE SIDE BUSINESS, I SLEEP
MAYBE TWO TO THREE HOURS A
NIGHT.
SOMETIMES.
AND THEN THAT CORRELATED ALSO
WITH MY DAUGHTER BEING -- I
DON'T KNOW WHAT IT IS BUT WE
HAVE THESE PHASES OF WHERE SHE
WANTS TO BE UP ALL DAY, SLEEP
FROM 5:00 TO 7:00 AND THEN BE UP
HALF THE NIGHT.
SO IN THAT SENSE, I SAID WHAT
ARE WE GOING TO DO ABOUT THIS
AND WHERE ARE WE GOING TO GO
ABOUT THIS AND MY HUSBAND
BROUGHT UP, ARE THEY GOING TO
GET US A NEW BED?
I WAS LIKE, NO.
BUT YOU KNOW, IN THAT SENSE, IT
DOES CORRELATE WITH ANOTHER ONE
OF MY DIAGNOSES, WHICH IS
FIBROMYALGIA.
I DON'T GET SLEEP, MY BODY WILL
BE INFLAMED FOR DAYS.
SO ONE THING THAT I HAD TO DO
WAS A RESOURCE THAT WAS ADDED TO
US IS TO -- WITH MY DAUGHTER'S
OCCUPATIONAL THERAPIST WAS FOR
US TO TRAIN OURSELVES, PUT
OURSELVES ON A TIME SCHEDULE AND
WHATNOT.
SO THAT WAS ONE OF THE RESOURCES
THAT WE WERE ACTUALLY OFFERED BY
THE BIRTH COHORT STUDY.
SO JUST LIKE JADINE SAID, I'D
LIKE TO SHOUT OUT TO OUR NAVAJO
NATION STUDY BECAUSE THOSE
LADIES ARE ON IT.
WE CAN DO THIS, WE CAN REFER YOU
TO THESE GUYS, SO THAT'S ONE
THING THAT WE'RE GRATEFUL FOR
FROM THE PROGRAM.
>>JUST FULL DISCLOSURE, I DID
NOT PUT HER UP TO THIS.
I DON'T THINK I EVER IDENTIFIED
BUT I'M THE P.I. OF THE -- I WAS
THE ORIGINAL P.I. OF THE BIRTH
COHORT STUDY.
SO TOTAL -- JUST -- WHATEVER.
VIVAINNETE, WHAT FORMAT WOULD BE
THE MOST USEFUL FOR YOU IN TERMS
OF UNDERSTANDING THIS KIND OF
INFORMATION?
?REUSH
[SPEAKING FOREIGN LANGUAGE]
>>ALWAYS POSSIBLE, ALL KINDS OF
FORMATS WOULD BE WELCOME.
ESPECIALLY TO HAVE ACCESS TO A
WEBPAGE WHERE I CAN GET THE
INFORMATION.
>>MY EXPERIENCE OF GETTING MY
REPORT BACK IN A GROUP WITH
OTHER PARTICIPANTS IS VERY
HELPFUL BECAUSE WE CAN SHARE, WE
ARE IN THE SAME BOAT SO TO SPEAK
AND CAN LOOK FOR NEW SOLUTIONS
TOGETHER.
IN THE GROUP FORMAT, WE DON'T
DISCUSS MY RESULTS DIRECTLY OR,
YOU KNOW, PUBLICLY.
THE INFORMATION THAT'S
PRESENTED, I CAN APPLY TO THE
RESULTS THAT I GET.
>>LAST FORMAL SCENARIO, THEN
WE'LL GO TO A COUPLE OF OTHER
QUESTIONS.
SO YOU SENT RESULTS FROM A
NUTRITIONAL EVALUATION OF YOUR
DIET, AND YOU'RE TOLD THAT
SEVERAL MICRONUTRIENTS ARE BELOW
LEVELS THAT THE WORLD HEALTH
ORGANIZATION CONSIDERS
SUFFICIENT FOR NORMAL
DEVELOPMENT OF ORGANS IN THE
CENTRAL NERVOUS SYSTEM.
EMILY, WHAT WOULD BE YOUR
PERSONAL REACTION TO THESE
RESULTS?
THESE AGAIN, NOW WE'RE LOOKING
AT SOMETHING THAT'S AN
INDIVIDUAL BEHAVIOR, TYPE
RESULT, BUT ALSO SOMETHING THAT
WOULD AFFECT THE WHOLE FAMILY,
SO IT'S A LITTLE BIT DIFFERENT
CATEGORY.
SO IF YOU COULD LET US KNOW WHAT
YOUR REACTION MIGHT BE, AND THE
QUESTIONS THAT YOU WOULD WANT
ANSWERED IN THAT INFORMATION?
>>SO WHEN I FIRST READ THIS
QUESTION, MY INITIAL THOUGHT
WAS, AM I PREGNANT OR NOT?
WHEN I GET THESE RESULTS.
BECAUSE I DON'T -- YEAH, IF IT'S
JUST ME, I KIND OF LIVE WITH
THERE'S GOING TO BE A DEFICIT OF
SOMETHING, RIGHT, LIKE AS A
PARENT OF ALMOST FIVE KIDS WHO
WORKS FULL TIME.
BUT LIKE EITHER SLEEP OR FOOD OR
IRON OR -- YOU KNOW, I'LL BE
DEFICIT IN SOMETHING.
IT'S A TOTALLY DIFFERENT
SCENARIO IF I'M GETTING THIS
AND, LIKE, OH, YOU'RE THE ONLY
SOURCE OF NUTRITION FOR THIS
HUMAN BEING, OR, YOU KNOW, THIS
IS ONE OF THOSE RESULTS THAT
LIKE EVEN IF IT CAME THREE YEARS
LATER, I'D WANT TO KNOW, BECAUSE
IT IMPACTED THAT CHILD AND EVERY
SUBSEQUENT CHILD THAT I'VE HAD.
AND THE LEVEL OF ANXIETY WOULD
CHANGE BASED ON WHAT -- WHERE I
AM, BUT THINKING ABOUT -- AGAIN,
I'M A BROKEN RECORD HERE BUT I
WOULD LOVE TO HAVE SOME KIND OF
NEXT STEP PRESENTED ALONGSIDE
THE -- YOU KNOW, HERE'S SOME BAD
NEWS.
AND I APPRECIATE THE CONTEXT OF
LIKE HERE'S WHAT THE WORLD
HEALTH ORGANIZATION RECOMMENDS
OR HERE'S WHAT WOULD BE
COMPARABLE OR, LIKE, MANY PEOPLE
IN NEW HAMPSHIRE ARE DEFICIENT
IN VITAMIN D, LIKE WHATEVER THE
NUTRIENT WOULD BE, IF THERE WAS
SOME CONTEXT TO IT IN ADDITION
TO THOSE LIKE HERE'S SOMETHING
YOU COULD DO TO HELP AND IT
DOESN'T MATTER WHEN I GET THOSE
RESULTS, I WOULD WANT TO KNOW.
>>JADINE, DO YOU WANT TO ALSO
TALK A LITTLE BIT ABOUT THE
CONTEXT THAT YOU'D LIKE TO GET
THAT KIND OF NUTRITIONAL
INFORMATION IN?
>>YES.
SO I WOULD THINK THAT I WOULD
LIKE TO BE -- I WOULDN'T
NECESSARILY SAY TO LIKE MAIL ME
THE INFORMATION, BUT LIKE, I
THINK A PAPER OR, LIKE, MY
TRUSTED PERSON WITH THE STUDY, I
THINK SOME FORMAT OF GETTING THE
INFORMATION.
IT DOESN'T REALLY MATTER HOW FOR
THIS ONE IN THE INSTANCE BECAUSE
I THINK THAT ANY WAY IT'S
CONVENIENT, WHETHER IT'S THROUGH
A CHART OR A LETTER OR VIDEO, I
THINK THAT IT'S IMPORTANT TO GET
IT OUT THERE IN ANY WAY THAT YOU
SEE IS, LIKE, FIT.
I THINK THAT IN ANY WAY BEING A
20-YEAR-OLD, OR NOW THAT I'M
LIVING ON MY OWN, I THINK THAT
IT IMPORTANT FOR ME TO KNOW
BECAUSE I BUY MY OWN GROCERIES,
SO I NEED SOMETHING TO LET ME
KNOW WHETHER TO STAY AWAY TBR
THIS FOOD OR TO GET MORE OF THIS
FOOD FOR MYSELF SO I CAN BE, YOU
KNOW, GOOD ON NUTRIENTS.
>>AND VIVAINNETE, WHAT KINDS OF
CHANGES, GIVEN WHERE YOU LIVE
AND DIFFICULTIES IN ACCESS, WHAT
KINDS OF CHANGES MIGHT YOU WANT
TO MAKE AND WHAT WOULD THOSE
BARRIERS BE?
[SPEAKING FOREIGN LANGUAGE]
>>SO MORE THAN -- I WOULD LIKE
TO KNOW AFTER I MAKE THESE
CHANGES, I WOULD LIKE TO KNOW
WHAT IS THE RESULT OF THIS
CHANGE IN MY BODY, IF I HAVE
COME BETTER, THAT IS SOMETHING
THAT IS IMPORTANT.
[SPEAKING FOREIGN LANGUAGE]
>>I WOULD LIKE TO KNOW WHERE I
CAN GET FOOD THAT HAS NUTRIENTS
THAT I'M LACKING.
I WOULD ALSO LIKE TO KNOW IF
THERE'S A PROGRAM THAT WOULD
SUPPORT ME IN THIS.
>>ONE OF THE BARRIERS IS LIVING
ON AN ISLAND AND THE LACK OF
ACCESS TO ALL THE NUTRIENTS OR
ALL THE FOOD THAT WE WOULD NEED.
AND WE ALSO KNOW THAT TO EAT
HEALTHY COSTS MORE.
IT'S EXPENSIVE TO EAT HEALTHY.
>>GREAT POINTS.
THANK YOU.
AND PAMELA, HOW WOULD YOU SEE
THE FORMAT THAT WOULD BE MOST
USEFUL FOR YOU FOR THESE
RESULTS?
AND THE COMPARISONS THAT YOU'D
WANT TO SEE?
>>FOR THIS INSTANCE, I THINK WE
ARE -- THIS WOULD PROBABLY BE A
SUGGESTION.
WE'RE FORTUNATE IN THE WOMEN'S
HEALTH CLINIC THAT I WORK IN
THAT OUR COHORT HAS GOOD
RELATIONSHIPS WITH OUR
PROVIDERS.
FOR INSTANCE, YOU WERE SAYING
WHAT DO THE PROVIDERS DO WHEN
THEY GET THE REPORT, OR IF THEY
GET A RESULT BACK.
IT'S FUNNY BECAUSE THIS HAS
HAPPENED WITH ONE OF OUR
PROVIDERS, HE'S LIKE, HE'LL LOOK
AT SOMETHING AND HE'D BE LIKE, I
HAVE NO IDEA WHAT THIS IS, BUT I
CAN -- WE'LL FIND SOMEBODY WHO
KNOWS WHAT IT IS, AND WE'LL
FIGURE OUT WHAT WE'RE GOING TO
DO ABOUT IT.
THAT'S HIS ENTHUSIASM AS FAR
AS -- WE DO EVERY TUESDAY
MORNING A CLINIC CALL THE
SPECIAL CARE O.B., FOR OUR O.B.
PATIENTS.
IN OUR CLINIC, WE DO DAILY
WALK-INS SO HE IF WE HAVE A
POSTPARTUM MOM WHO COMES BACK
WITH A RESULT, OR IN THIS CASE,
WE CAN GET OUR COHORT THE LADIES
IN OUR PROGRAM WOULD USUALLY
APPROACH ONE OF THE PROVIDERS
AND ASK IF THEY COULD MEET WITH
THE PATIENT AND SEE IF THEY
COULD GET A REFERRAL TO OUR
NUTRITIONIST WITHIN THE
FACILITIES.
AND THEN THEY WOULD LTION REFER
THEM BACK TO A PRIMARY CARE
PROVIDER WHO COULD MANAGE, LIKE
IF THEY NEED VITAMIN D, THEY CAN
PRESCRIBE THEM THE VITAMIN D,
AND THEN THEY WILL ALSO FOLLOW
UP BIWEEKLY WITH OUR
NUTRITIONISTS IN OUR CLINICS.
FOR ME, IT WOULD BE THE CELIAC
DISEASE IS WHAT I WAS RECENTLY
DIAGNOSED WITH, THAT PERTAINS TO
MY FIBROMYALGIA AS WELL, AND IT
IS HARD AND EXPENSIVE TO KEEP ON
THIS DIET.
LIKE, EVERYTHING GLUTEN-FREE, I
CAN'T EAT WHEAT, RYE, AND THE
SAME GOES FOR MY DAUGHTER.
SHE IS ALLERGIC, ALLERGIC TO
DAIRY.
SHE CAN'T -- SO WE HAVE TO DO
THINGS, COOK MEALS DIFFERENTLY,
AND I WAS JUST SAYING THIS
MORNING, ONE.
LADIES ASKED, ARE YOU KIDS OKAY
WITHOUT YOU?
ONE OF OUR PROVIDERS, HER NAME
IS DR. DELAVLEY, SHE WAS LIKE
WHERE DO YOU FIND THESE KIDS AT?
BUT THEY'RE FINE.
WE MAKE CROCK POT MEALS AND WE
HAD TO GO BUY THAT SPECIFIC DIET
BUT IT DOES GET PRICEY.
LIKE I SAID, WE ARE VERY
FORTUNATE THAT WE DO HAVE THE
SUPPORT THAT WE DO HAVE FROM THE
COHORT PROGRAMS, AND THEM
REACHING OUT TO OTHER PROGRAMS
LIKE OUR FRUIT AND VEGETABLE
PROGRAM IS ALSO UNDER THE
WOMEN'S HEALTH PROGRAM IN CHIN
LEE WHERE THEY GIVE OUR MOMS UP
TO $100 IN FRUIT AND VEGETABLE
VOUCHERS TO HELP WITH INSTANCES
LIKE THIS, THEY WOULD JUST NEED
A REFERRAL FROM OUR PROVIDERS.
>>I WANT TO CLOSE WITH JUST A
FEW GENERAL QUESTIONS AND
WHOEVER HAS A THOUGHT ON THEM
CAN JUST ANSWER THEM.
IS THERE ANYTHING IN THE RESULTS
THAT YOU'VE GONE THROUGH SO FAR
THAT YOU REALLY DON'T WHAT TO
HAVE BACK?
THERE ARE A TON OF RESULTS HERE,
SO LOOKING AT SORT OF WAYS TO
PRIORITIZE, WHAT WOULD YOU PUT
THE LOWEST PRIORITY ON?
>>JUST FROM A TECHNICAL
PERSPECTIVE, IF THE RESULTS ARE
NORMAL, IF THERE'S A WAY TO LIKE
SUMMARIZE THOSE IN A LOW EFFORT
MANNER AND SEND THOSE OUT IN A
DIGEST, YOU KNOW, SOMETHING LESS
FREQUENT, THAT'S FINE.
LIKE THAT'S KIND OF THE LOWEST
PRIORITY OF COMMUNICATION, IF
THERE'S NOTHING STRANGE, THE
EXPECTED RESULTS, YEAH.
>>ANYBODY ELSE HAVE A THOUGHT
ON THAT?
>>I THINK IT WOULD JUST BE THE
SAME THING LIKE WHETHER IT'S
WITHIN THE STANDARDIZED OR
WITHIN OUR COMMUNITY AND OUR
POPULATION IN OUR COMMUNITIES
ARE WITHIN THAT RANGE, IT WOULD
BE SOMETHING THAT WOULDN'T BE --
FOR ME, LIKE, I WORRY ABOUT
EVERYTHING.
BUT I THINK --
>>WITH GOOD REASON.
>>I THINK IT WOULD BE LIKE IF
IT'S AT A STANDARDIZED RANGE TO
WHERE IT'S -- WITHIN OUR
COMMUNITY IS IN THAT SAME RANGE,
IT WOULDN'T BE SO --
>>SO WE ALSO TALKED BEFORE,
THOUGH, ABOUT IF -- BECAUSE SOME
COHORTS HAD A PRACTICE THAT IF
YOU WERE WITHIN A NORMAL RANGE,
THEY JUST WOULDN'T COMMUNICATE
THAT BACK.
SO YOU KNEW AHEAD OF TIME THAT
YOU WOULD ONLY BE GETTING
RESULTS IF THEY WERE OUTSIDE OF
THAT NORMAL RANGE.
AND WE HAD SOME OPINIONS ON THAT
AND WHETHER THAT WAS ACCEPTABLE
OR NOT, AND WOULD SOME OF YOU
LIKE TO WEIGH IN ON THAT?
>>I THINK THAT WHETHER OUR
RESULTS WERE NEGATIVE OR NORMAL,
I THINK THAT YOU SHOULD BE GIVEN
THAT INFORMATION.
I THINK PRIORITY SHOULD
DEFINITELY GO TO INFORMATION
THAT IS DIRE FOR US TO KNOW, BUT
I THINK THAT IF A NORMAL RESULT,
THAT WE CAN GET IT IN THE --
LIKE A LETTER OR, LIKE,
SOMETHING THAT, YOU KNOW,
DOESN'T SCARE A PARTICIPANT THAT
YOU KNOW.
KNOW SOMETHING THAT IS EASY
FOR EVERYONE TO RECEIVE AND, YOU
KNOW, STILL SLEEP PEACEFULLY
THAT WE HAVE NORMAL RESULTS --
PENDING RESULTS AS WELL.
>>ANYBODY ELSE WANT TO --
>>
[SPEAKING FOREIGN LANGUAGE]
>>I BELIEVE THAT WE SHOULD GET
THE RESULTS NO MATTER WHAT IT
IS.
WE GIVE OUR TIME TO THESE
STUDIES AND THIS CREATES A
RELATIONSHIP OF TRUST THAT WE
CAN IMPROVE CONDITIONS FOR
OURSELVES AND OUR FAMILIES.
>>JUST ONE PARTING THOUGHT IS
THAT WHEN WE WERE TALKING THIS
MORNING ABOUT YOU DON'T WANT TO
DO HARM, I FEEL LIKE WE'RE AT A
STAGE WHERE WE'RE USED TO
INFORMATION, IT'S HARD TO DO
HARM JUST BY GIVING US
INFORMATION.
GRANTED I'M NOT A LAWYER, BUT
THINKING ABOUT THE PUZZLES THAT
I WILL HAVE TO SOLVE ABOUT MY
HEALTH AND MY CHILDREN'S HEALTH,
YOU AS RESEARCHERS JUST WON'T
HAVE WINDOWS INTO ALL THOSE
COMPLEXITIES, BUT I WOULD LOVE
TO HAVE YOUR HELP IN PUTTING
TOGETHER THE PUTZ PUZ EL IF
THERE IS SOMETHING ABOUT WATER
QUALITY THAT WOULD IMPACT THINGS
DOWN THE ROAD, I WOULD LOVE TO
HAVE THE DATA THAT I HAD NORMAL
WATER BACK IN 2017.
THAT'S THE KIND OF THING THAT
JUST HELPS BUILD -- IS SOMETHING
FOR ME TO ADVOCATE FOR MYSELF IN
THE LONG RUN AND YOU JUST WON'T
HAVE THAT PERSPECTIVE BUT YOU
CAN BE PART OF MY TEAM.
>>I THINK GETTING BACK THE
RESULTS FOR ME WOULD BE, I WOULD
LIKE TO GET RESULTS BACK WHETHER
OR NOT THEY'RE NORMAL OR
ABNORMAL, EVEN IF IT'S LIKE IN A
QUARTERLY REPORT OR A QUARTERLY
LETTER, EMAIL OR WHATEVER.
AND THEN JUST BECAUSE THAT WAY
IF FOR FUTURE REFERENCES LIKE IF
MY DAUGHTER PAISLEY, WHO IS
VERY -- WHO'S USING THE PROGRAM
RESOURCES VERY EFFICIENTLY AND
VERY OFTEN, THAT, YOU KNOW, WE
CAN DO A COMPARISON TO LATER ON
IN LIFE, IF SHE EVER HAS HER OWN
CHILDREN, AS FAR AS NOT JUST
THAT, I DO HAVE A GRANDSON WHO
IS A PART OF THE PROGRAM AS
WELL.
JUST THINGS LIKE THAT, WE WOULD
LIKE TO HAVE THOSE REFERENCES
FOR FUTURE, FOR OUR NEXT
GENERATIONS, AS I THINK THAT'S
VERY IMPORTANT.
>>
[SPEAKING FOREIGN LANGUAGE]
GLS NOW I HAVE A QUESTION.
UP TO WHAT POINT IT IS MY RIGHT
TO HAVE ACCESS TO THIS
INFORMATION?
>>AND I WOULD LIKE TO HAVE
SOMEONE WITH LEGAL BACKGROUND
ANSWER THAT.
I CERTAINLY HAVE AN OPINION,
BUT -- DO WE HAVE ANYONE THAT
WANT TO JUMP IN THERE?
SO I HAVE A SUSPICION THAT WHAT
THE ANSWER WOULD BE WOULD BE THE
CONSENT FORM THAT'S SIGNED, AND
THAT'S WHERE IT'S GOING TO BE
LAID OUT, WHAT INFORMATION AND
WHAT THE INTENT IS, AND I WOULD
SEE THAT AS SOME LEVEL OF A
CONTRACTUAL AGREEMENT BETWEEN
YOU AND THE STUDY.
OTHER THOUGHTS?
>>I KNOW COMING FROM THE
CLINICAL SETTING, HIPAA DOES
COME IN PART WITH THAT, BUT IF
THERE'S A CONSENT SIGNED AND
IT'S AT THE PARTICIPANT'S
REQUESREQUESTEE, YOU CAN HAVE YR
RECORDS.
THEY'RE YOUR RECORDS.
>>
[SPEAKING FOREIGN LANGUAGE]
>>ONE OF MY PRIORITIES IN
PARTICIPATING IN THE STUDY IS
PRECISELY THAT, THAT I WILL GET
BACK MY RESULTS.
>>I'M GOING TO MOVE ON TO ONE
LAST QUESTION AND THEN OPEN IT
UP FOR QUESTIONS FROM AUDIENCE.
AND IT GOES BACK TO THE QUESTION
THAT CAME UP BEFORE ABOUT THE
TIMING OF RESULTS.
AND IT'S NOT UNCOMMON AS YOU'VE
HEARD OVER AND OVER TODAY THAT
SOME OF THESE LABORATORY
ANALYSES CAN TAKE UP TO TWO
YEARS TO GET BACK FOR VARIOUS
REASONS.
AND ARE THERE ANY INCIDENCES
WHERE YOU WOULD STILL WANT THOSE
DATA OR YOU WOULD NOT WANT THOSE
DATA, AND IF YOU CAN JUST KIND
OF DISCUSS THAT TIMING ISSUE,
THAT WOULD BE HELPFUL.
>>ME PERSONALLY WITH THE
TIMING, I THINK NO MATTER HOW
LONG IT TAKES TO GET THE RESULT,
I THINK IF THERE'S AN INITIAL
ONE FOR THAT INFORMATION,
REGARDLESS HOW LONG IT TAKES, I
THINK WE SHOULD GET THAT
INFORMATION.
EVEN IF SOMETHING HAPPENED THAT
IS NOT NECESSARILY PREVENTABLE,
BUT I THINK THAT IT CAN BE
PROACTIVE FOR THE NEXT CHILD OR
MYSELF IN THE FUTURE TO AVOID
SOMETHING OR TO, YOU KNOW, GET
MORE OF A CERTAIN KIND OF
NUTRIENTS.
YOU KNOW, I THINK THAT IT'S --
IT'S IMPORTANT EITHER WAY
BECAUSE YOU HAD A FEELING THAT
YOU WANTED IT, AND I THINK THAT
WE SHOULD GET IT.
>>ANYBODY HAVE A DIFFERENT
OPINION?
OKAY.
CAN WE TAKE QUESTIONS?
WE HAVE ONE BACK THERE.
>>THANKS SO MUCH FOR THIS
PANEL.
IT JUST A LOT OF FASCINATING
PERSPECTIVES.
I WANTED TO FOLLOW UP ON SORT OF
THAT FIRST EXAMPLE, WHERE YOU
HAVE A CHEMICAL EXPOSURE WHERE
THERE'S REASON FOR CONCERN BUT
NOT SORT OF DEFINITIVE
INFORMATION ABOUT HOW -- WHAT
THE IMPLICATIONS ARE FOR HEALTH.
SO YOU PEOPLE TALK ABOUT HOW
THEY WANT INFORMATION ABOUT SO
WHAT CAN I DO TO REDUCE MY
EXPOSURE.
SO TWO QUESTIONS, REALLY.
ONE WOULD BE WOULD YOU HOPE OR
EXPECT THE STUDY TO DO FOLLOW-UP
TESTING TO SEE WHETHER YOUR
ACTIONS HAVE BEEN HELPFUL OR NOT
TO REDUCE YOUR EXPOSURE?
AND THEN SECONDLY, SORT OF
PICKING UP ON A VERY RECENT
COMMENT, IF THE HEALTH COMMUNITY
WERE TO FIGURE OUT IN FIVE OR 10
YEARS WHAT THE HEALTH
IMPLICATIONS WERE FOR THIS
CHEMICAL, AND EITHER YES, IT'S A
SERIOUS PROBLEM, OR NO, IT'S NOT
A PROBLEM AT ALL, 10 YEARS FROM
NOW, WOULD YOU EXPECT THE STUDY
TO -- HOPE OR EXPECT THE STUDY
TO RECONTACT YOU TO GIVE YOU
THAT INFORMATION?
>>I WOULD SAY YES TO BOTH OF
THOSE QUESTIONS.
BECAUSE FIRST I THINK THAT --
I'M SORRY
>>WHAT WAS THAT FIRST QUESTION?
>>SECOND QUESTION WAS ABOUT
FINDING OUT MORE CONCRETE
INFORMATION IN FIVE OR 10 YEARS
ABOUT WHAT THIS EXPOSURE MEANS
FOR YOU OR YOUR BABY.
>>SO I WOULD DEFINITELY STILL
WANT THE INFORMATION AND I THINK
LIKE I SAID, NO MATTER HOW LONG
IT TAKES, WE DESERVE THE
INFORMATION TO BE GIVEN TO US
AND I THINK THAT IF IT WERE TO
BE 10 YEARS DOWN THE LINE, I
WOULD HOPE THAT YOU GUYS STILL
HAD THAT SAME DEDICATION TO
COLLECT THE INFORMATION, THAT
YOU HAD THAT SAME DEDICATION TO
GIVE US OUR RESULTS BACK NO
MATTER HOW LONG IT TAKES AND TO
FIND -- NOT THAT YOU GUYS ARE
DETECTIVES OR ANYTHING, BUT I
THINK THAT IF YOU WANT TO FIND
OUT INFORMATION BAD ENOUGH, THAT
YOU WILL GIVE YOUR BEST EFFORTS
TO GIVE THAT INFORMATION BACK TO
YOUR PARTICIPANTS, BECAUSE WE
GIVE YOU SO MUCH TOO.
IT GIVE AND TAKE.
>>THAT WAS A GREAT CULMINATING
QUESTION AND RESPONSE, AND I
THINK IT'S ABOUT TIME THAT WE
SAY THANK YOU TO ALL OF OUR
PARTICIPANTS.
>>CAN I JUST ADD MY LEVEL OF
THANKS.
I REALLY, REALLY APPRECIATE ALL
OF YOU GIVING SUCH THOUGHTFUL
CONTRIBUTIONS, AND TRAVELING
HERE TO BE IN PERSON.
I KNOW IT'S NOT SORT OF ON YOUR
REGULAR SCHEDULE TO DO THOSE
KIND OF THINGS, AND IT'S REALLY,
REALLY HELPFUL TO HAVE YOU HERE.
SO THANK YOU SO MUCH.
>>I WANT TO SECOND THE THANKS.
REALLY APPRECIATE IT VERY MUCH.
WE'RE NOW AT OUR LUNCH BREAK, SO
OUR FOOD DELIVERY FOR PEOPLE WHO
ORDERED A DELIVERY IS OUT THERE,
AND CATHERINE FROM OUR PROGRAM
OFFICE IS HELPING TO GET THAT
ORGANIZED.
I THINK THEY MAY HAVE FAILED TO
LABEL EACH INDIVIDUAL ORDER, SO
NATURALLY ENOUGH, SO TRY TO
REMEMBER WHAT YOU ORDERED AND
THEN IF YOU'RE LOCAL STAFF, AS I
MENTIONED EARLIER, THERE'S A
CAFE JUST AROUND THE SIDEWALK,
AND YOU'RE FREE TO WALK THERE.
AND I DON'T KNOW, MAYBE WE
SHOULD MEET BACK AT 2:30, DO YOU
THINK?
YEAH.
LET'S -- WE HAD AN HOUR BUT
WE'RE STILL RUNNING BEHIND SO
LET'S RECONVENE AT 2:30.
THANK YOU.
>>WE'RE GOING TO GO AHEAD AND
GET STARTED AGAIN.
I'M TAKING THE PLACE OF ASHLEY
VARGAS, WHO'S ILL TODAY.
I'LL BE INTRODUCING SESSION
3 AND SERVING AS MODERATOR.
SO WE HEARD A LOT IN THE FIRST
HALF OF THE DAY ABOUT RESEARCH
RESULTS BEING RETURNED IN LARGE
VOLUME, AND A WIDE VARIETY OF
RESEARCH RESULTS THAT THE ECHO
PROGRAM IS GENERATING AND
PLANNING TO RETURN, BUT THAT
RAISES THE QUESTION OF HOW TO
DECIDE WHICH INDIVIDUAL RESULTS
TO RETURN TO PARTICIPANTS.
THAT'S THE TOPIC OF SESSION 3.
OUR CHAIR IS BENJAMIN BERKMAN OF
THE NIH.
THEN WE WILL ALSO HEAR, AFTER HE
SPEAKS FIRST, FROM ADRIANA ARCIA
OF THE UNIVERSITY OF SAN DIEGO,
THEN JULIE SAPP, ALSO FROM THE
NIH, AND THEN RACHEL
MORELLO-FROSCH FROM THE
UNIVERSITY OF CALIFORNIA,
BERKELEY.
AND OUR DISCUSSANT FOR THIS
SESSION IS CARMEN VELEZ VEGA
FROM UNIVERSITY OF PUERTO RICO
AND ALSO AN ECHO P.I.
SO WITH THAT, I'LL INVITE BEN
UP.
>>SO THANK YOU FOR HAVING ME.
I AM EXCITED TO BE HERE.
SO MY JOB IS TO INTRODUCE SH
SESSION ABOUT WHAT KINDS OF
RESULTS WE SHOULD THINK ABOUT
RETURNING, AND INTRODUCE SOME
ISSUES AND QUESTIONS ABOUT
FEASIBILITY FOR RETURN.
I SHOULD SAY I'M A FEDERAL
EMPLOYEE, SOMETIMES I SAY
CONTROVERSIAL THINGS AND SO
NOTHING THAT I SAY HERE
REPRESENTS THE VIEWS OF THE
FEDERAL GOVERNMENT OR ANYONE
THAT GETS TO MAKE ACTUAL
DECISIONS IN THE WORLD.
DO I HAVE TO DO SOMETHING TO --
GOOD.
SORRY.
OKAY.
SO OVERVIEW.
LET ME JUST GIVE YOU A SENSE OF
WHAT I WANT TO TALK ABOUT.
I'M GOING TO GIVE YOU SOME BROAD
IDEAS ABOUT CATEGORIES OF
RESULTS.
SOME OF WHICH WILL ECHO THINGS
THAT JEFF AND KYLE SAID EARLIER.
I'M GOING TO GIVE YOU A
FRAMEWORK FOR THINKING ABOUT
RETURNING RESEARCH RESULTS.
I WANT TO TALK ABOUT THE ISSUE
ABOUT WHETHER -- WHEN THEY HAVE
A DUTY TO LOOK FOR SPECIFIC
RESEARCH RESULTS OR WHEN IT'S
SUFFICIENT TO STUMBLE UPON
THINGS.
I WANT TO TALK ABOUT THIS BIG
QUESTION AT LEAST I'VE THOUGHT A
LOT ABOUT, WHEN DO YOU DRAW
DISTINCTIONS BETWEEN DIFFERENT
KINDS OF STUDIES, ARE THERE SOME
STUDIES THAT HAVE TO RETURN
RESULTS, SOME THAT SHOULD RETURN
RESULTS BUT HAVE MORE OF AN
OPTION, OR ARE THERE KINDS OF
STUDIES WHERE, GIVEN THE NATURE
OF THE STUDY AND THE
RELATIONSHIP THEY HAVE WITH
PARTICIPANTS, MAYBE THEY DON'T
HAVE TO RETURN RESULTS AT ALL.
AND THEN ANOTHER VERY
CONTROVERSIAL TOPIC ABOUT
SOLICITING PARTICIPANT
PREFERENCES.
WHEN DO YOU HAVE TO ASK, WHEN
CAN YOU SORT OF HAVE A DEFAULT
AND TELL PEOPLE WHAT YOUR
GENERAL PLAN IS.
AND THEN I'LL TALK ABOUT ANOTHER
COUPLE OF POLICY ISSUES QUICKLY.
SO FIRST I JUST WANT TO TALK
ABOUT SOME TERMINOLOGY, SO MAYBE
THIS CAN HELP US IN OUR
DISCUSSION.
THERE ARE REALLY THREE KINDS OF
RESULTS THAT I THINK ABOUT.
THEY'RE PRIMARY RESEARCH
RESULTS.
THESE ARE THINGS RELATED TO THE
CONDITION OR QUESTION UNDER
INVESTIGATION.
SO IF YOU'RE DOING RESEARCH ON
HEART DISEASE OR ENVIRONMENTAL
EXPOSURE, THESE ARE THINGS
RELATED TO THAT SPECIFIC
RESEARCH QUESTION.
THEN THERE ARE INCIDENTAL
QUESTIONS, THINGS THAT COME UP
IN THE COURSE OF DOING THE
RESEARCH BUT AREN'T QUITE
RELATED TO THE RESEARCH.
AND THEN THERE'S SECONDARY ANAL
CLINICAL RESULTS UNRELATED TO
THE QUESTIONS YOU'RE ASKING BUT
YOU'RE ACTIVELY GOING TO LOOK
FOR THEM.
SO IN GENETICS, WHICH IS THE
AREA I KNOW THE BEST, IF YOU'RE
DOING SEQUENCING, TO ASK A
SPECIFIC QUESTION ABOUT, SAY,
HEART DISEASE BUT THEN YOU
INTENTIONALLY GO LOOK FOR ALL
SORTS OF THINGS ABOUT CANCER AND
OTHER GENETIC CONDITIONS, THAT
WOULD BE A SECONDARY ANALYSIS.
I THINK IN THE ECHO PROGRAM,
GIVEN WHAT I UNDERSTAND ABOUT
IT, WE'RE PRIMARILY TALKING
ABOUT PRIMARY RESEARCH RESULTS,
BECAUSE THESE ARE ALL THINGS
THAT ARE BEING COLLECTED FOR A
PARTICULAR QUESTION THAT AREN'T
GOING TO BE TONS OF CASES OF
INCIDENTAL OR SECONDARY RESULTS
BUT THERE COULD BE.
SO A FRAMEWORK FOR THINKING
ABOUT THIS, AND I SHOULD PAUSE
AND SAY, YOU KNOW, RESEARCH
STUDIES CAN GIVE BACK ANY
RESULTS THAT THEY WANT AS LONG
AS THEY'RE DOING MORE GOOD THAN
HARM.
THE QUESTION I THINK ABOUT IS,
WHAT'S SORT OF THE LOWEST BAR?
WHERE'S THE THRESHOLD WHERE THEY
HAVE TO -- WHERE RESEARCH
PROGRAMS HAVE TO GIVE BACK A
CERTAIN AMOUNT OF RESULTS?
THEY'RE ALWAYS ALLOWED TO GIVE
BACK MORE THAN WH WHATEVER THATW
THRESHOLD IS, BUT WHEN THINKING
ABOUT HOW TO DEFINE THAT
THRESHOLD, PEOPLE THINK ABOUT --
AT LEAST IN EARLY GENETIC --
THOUGHT ABOUT CLINICAL
RELEVANCE, CLINICAL
SIGNIFICANCE, CLINICAL UTILITY
AND WE'VE SORT OF DISTILLED THIS
DOWN INTO THREE MAIN IDEAS.
YOU WANT TO RETURN RESULTS THAT
ARE VALID, THAT ACTUALLY MEAN
WHAT YOU THINK THEY MEAN, THAT
HAVE VALUE TO PARTICIPANTS, AND
WHERE THERE'S VOLITION, WHERE
THEY WANT THEM, WHERE THERE'S
SOMETHING -- WHERE THEY'VE
INDICATED THAT YOU HAVE CONSENT
TO GET IT.
I'M GOING TO FLY THROUGH THESE
BUT I PUT CITATIONS TO A WORK
THAT I AND OTHERS HAVE DONE SO
IF YOU HAVE ACCESS TO THE
SLIDES, YOU CAN SEE AND READ OUR
PAPERS IN MORE DETAIL.
JEFF TALKED ABOUT THIS EARLIER,
BUT THE WAY I THINK ABOUT VALUE
IS IN TERMS OF A FEW DIFFERENT
DIMENSIONS.
THERE'S SORT OF THE
DIRECT/INDIRECT DIMENSION.
SOMETIMES VALUE CAN DIRECTLY
INDICATE TO A PARTICIPANT
SOMETHING THAT THEY CAN DO,
EITHER PREVENTIVE SCREENING OR
EARLY TREATMENT OR LIFESTYLE
CHANGE OR CHANGING/AVOIDING
ENVIRONMENTAL EXPOSURE.
AND THEN THERE ARE THINGS THAT
ARE MORE INDIRECT, WHERE THERE'S
SOME SORT OF INTERVENING STEP,
SO LEARNING SOMETHING THAT
MIGHT, 10 YEARS FROM NOW, TELL
YOU SOMETHING ABOUT REPRODUCTIVE
DECISION THAT YOU HAVE TO MAKE.
OR SHORTENING A DIAGNOSTIC
ODYSSEY.
SO THERE'S THIS DIRECT/INDIRECT
DISTINCTION AND THEN THERE'S
THIS DISTENTION BETWEEN CLINICAL
AND PERSONAL UTILITY.
SO CLINICAL UTILITY IS
SOMETHING -- TREATMENT YOU CAN
TAKE, PREVENTIVE STEP YOU CAN
TAKE, VERSUS PERSONAL UTILITY,
WHICH IS JUST SORT OF KNOWLEDGE
THAT HELPS YOU LIVE YOUR LIFE
DIFFERENTLY.
AND I'M NOT SAYING THERE'S
BETTER OR WORSE BUT SOMETIMES
PEOPLE DRAW DISTINCTIONS BETWEEN
THESE WHEN THINKING ABOUT WHERE
TO DRAW THAT THRESHOLD.
AND KEY IN SOME OF THESE
DISTINCTIONS IS THE CONCEPT OF
ACTION ABILITY, THE IDEA THAT
YOU CAN DO SOMETHING WITH THE
INFORMATION.
IF YOU CAN DO SOMETHING WITH THE
INFORMATION THAT HEIGHTENS THE
ARGUMENTS THAT YOU CAN MAKE THAT
THIS IS SOMETHING THAT YOU
SHOULD RETURN.
IF THERE'S NOTHING TO DO WITH
THE INFORMATION, IT MIGHT STILL
BE VALUABLE, STILL MIGHT BE
SOMETHING YOU WANT TO RETURN BUT
THE ARGUMENTS FOR RETURNING IT
ARE A LITTLE BIT WEAKER.
SO TO THIS QUESTION ABOUT
WHETHER OR NOT THERE'S A DUTY TO
LOOK, OR WHETHER RESEARCH
PROGRAMS SHOULD JUST SORT OF
STUMBLE UPON THINGS, THE MAIN
REASON WE THINK ABOUT IMPOSING A
DUTY TO LOOK ON A RESEARCH
PROGRAM IS THE IDEA OF
BENEFICENCE, THE IDEA THAT SOME
GENETIC OR OTHER KINDS OF
INFORMATION COULD BE IMPORTANT
TO THEM, CLINICALLY IMPORTANT TO
THEM.
BUT HERE'S THE TENSION, AND
WE'VE BEEN TALKING ABOUT THIS A
LITTLE BIT THROUGHOUT THE DAY.
RESEARCH IS NOT THE SAME THING
AS CLINICAL CARE.
RESEARCHERS DON'T HAVE THE SAME
SORT OF RELATIONSHIP WITH A
PARTICIPANT AS A DOCTOR DOES
WITH THE PATIENT, AND SO YOU
GENERALLY DON'T EXPECT
RESEARCHERS TO BE PROVIDING
PARTICIPANTS WITH THE FULL RANGE
OF CLINICAL NEEDS THAT THEY
HAVE.
SOMETIMES THEY HAVE TO PROVIDE
SOME OF THEM BUT NOT ALL OF
THEM.
SO HOW DO YOU TEASE OUT THAT
DISTINCTION?
SO I THINK KYLE REFERRED TO THIS
EARLIER, THERE'S THIS IDEA OF
THE DUTY TO RESCUE OR ANCILLARY
CARE IS THE RULE SPECIFIC DUTY
RESEARCHERS TALK ABOUT WHERE I
THINK KYLE ALREADY PUT THESE UP,
SO GENERALLY WHEN THERE'S THE
INFORMATION HAS A LOT OF BENEFIT
TO PEOPLE, IT'S NOT THAT HARD TO
GIVE TO THEM, AND YOU HAVE A
UNIQUE OPPORTUNITY, THE
RESEARCHER HAS A UNIQUE
OPPORTUNITY TO HELP THEM, THOSE
ARE GENERALLY THE TIMES WHEN WE
THINK IT MIGHT BE MORE PLAUSIBLE
THAT THERE'S A DUTY TO LOOK,
THAT THERE'S MORE OF AN
OBLIGATION TO ACTIVELY FIND AND
THEN RETURN CERTAIN KINDS OF
INFORMATION.
THE REASON I LIKE THIS FRAMEWORK
IS BECAUSE IT BALANCES THE
BENEFIT TO THE PARTICIPANT WITH
THE BURDEN TO THE RESEARCH
ENTERPRISE.
IT TAKES BOTH INTO
CONSIDERATION, AND GIVES YOU
FRAMEWORK FOR THINKING ABOUT HOW
TO BALANCE THOSE TWO COMPETING
INTERESTS.
BUT THEN WE GET TO THIS HARD
QUESTION ABOUT HOW TO DRAW A
DISTINCTION BETWEEN RESEARCH
PROGRAMS THAT SHOULD DEFINITELY
RETURN FINDINGS AND OTHER ONES
THAT MIGHT NOT HAVE TO.
SO FOR EXAMPLE, IN THE NHGRI AND
IN THE NIH INTRAMURAL PROGRAM,
WE HAD COLLEAGUES AT NIEHS
SIMILAR TO THE ECHO STUDY, THIS
BIG, BIG ENVIRONMENTAL HEALTH
STUDY, AND THEY'RE DOING GENETIC
SEQUENCING, AND THE QUESTION
WAS, ARE THEY SIMILAR ENOUGH TO
THE MORE DIRECTLY CLINICAL KINDS
OF PROTOCOLS THAT THEY SHOULD
HAVE THE SAME KINDS OF
EXPECTATIONS THAT THEY'RE GOING
TO RETURN GENETIC INCIDENTAL
FINDINGS?
AND IT WAS AN OPEN QUESTION, AND
PEOPLE WENT BACK AND FORTH.
BUT THE IDEA IS, MAYBE THERE ARE
DIFFERENCES BETWEEN RESEARCH
PROGRAMS THAT WOULD HELP US SORT
WHICH ONES SHOULD OR SHOULDN'T
HAVE TO RETURN INFORMATION TO
PARTICIPANTS.
SO THE ARGUMENT I'VE MADE BEFORE
IS THE STRONGER THE
RELATIONSHIP, IGNORE THE
CLINICAL RELATIONSHIP, CLINICAL
RELATIONSHIP IS UP HERE, BUT YOU
CAN STILL HAVE STRONG
RELATIONSHIPS THAT ARE
NON-CLINICAL.
THE STRONGER THE RELATIONSHIP
BETWEEN THE STUDY AND THE
PARTICIPANT, THE MORE WE SHOULD
PRESUME IN FAVOR OF DISCLOSURE.
SO THESE ECHO COHORTS THAT HAVE
20-YEAR RELATIONSHIPS WITH THEIR
PARTICIPANTS, THOSE ARE THE
KINDS OF STRONG RELATIONSHIPS
THAT ARGUE IN FAVOR OF A MORE
EXPANSIVE KIND OF DISCLOSURE.
IF IT'S A STUDY WHERE YOU HAVE A
ONE-TIME BLOOD DRAW AND THAT'S
THE ENTIRE EXTENT OF YOUR
INTERACTION WITH THE RESEARCH
TEAM, MAYBE THERE'S LESS OF AN
OBLIGATION IN THOSE KINDS OF
SITUATIONS.
SO JUST TO GIVE YOU SOME
EXAMPLES, IF YOU HAVE SECONDARY
RESEARCH WHERE THE SAMPLES ARE
COLLECTED ELSEWHERE, THE
RESEARCHERS ARE JUST TAKING
THESE OTHER SAMPLES, MAYBE
THEY'RE DE-IDENTIFIED, I THINK
IN THOSE KINDS OF CASES,
GENERALLY YOU DON'T HAVE TO BE
RETURNING RESULTS TO PEOPLE.
NOW YOU COULD.
IT MAY BE HARD BECAUSE YOU MIGHT
NOT HAVE A RELATIONSHIP WITH
THOSE PEOPLE BUT YOU COULD, BUT
YOU WOULDN'T NECESSARILY HAVE
TO.
STUDIES THAT INVOLVE EXTENSIVE
REPEAT INTERACTIONS LIKE ECHO, I
THINK THOSE ARE ONES THAT
PROBABLY SHOULD BE RETURNING
FINDINGS TO PEOPLE.
THEN THE ONE-TIME INTERACTION, I
USE THE EXAMPLE OF ONE WHERE YOU
MIGHT NOT HAVE TO RETURN RESULTS
BUT THAT'S NOT NECESSARILY TRUE.
THERE MIGHT BE CASES, WE WERE
TALKING EARLIER ABOUT THE IDEA
OF A CENTRALLY CREATED RESOURCE
THAT HELPS RETURN RESULTS TO
PEOPLE.
WELL, IF IT GOT REALLY EASY, IF
WE HAD THAT KIND OF -- IF ECHO
HAD A CENTRAL OFFICE THAT SORT
OF PREPARED AND WAS REALLY GOOD
AT RETURNING RESULTS TO PEOPLE,
WELL, THEN MAYBE EVEN IF PEOPLE
DIDN'T HAVE A TON OF INTERACTION
WITH THE RESEARCH TEAM, WE MIGHT
WANT TO EXPAND THE OBLIGATION TO
THOSE LOWER INTERACTION KINDS OF
STUDIES.
BUT THAT'S MORE DEBATABLE.
THAT'S AN OPEN QUESTION.
SO ONE MORE BIG ONE BEFORE I RUN
OUT OF TIME.
THERE'S BEEN A LOT OF DEBATE IN
THE GENETICS WORLD ABOUT
SOLICITING PREFERENCES.
WHEN PEOPLE ARE GOING TO BE
GETTING RESULTS BACK, DO YOU
HAVE TO ASK THEM EXPLICITLY FOR
THEIR PERMISSION OR CAN YOU JUST
SAY, HERE'S WHAT WE'RE GOING TO
RETURN TO YOU IF YOU HAVE A
QUESTION, YOU CAN ASK US ABOUT
IT, AND IN THE CONSENT FORMS, DO
YOU NEED A CHECK BOX, YOU NEED
TO SAY YES, I WANT THIS KIND OF
INFORMATION OR NO, I DON'T WANT
THIS KIND OF INFORMATION, OR CAN
YOU JUST HAVE A DEFAULT AND TELL
THEM WHAT YOU'RE GOING TO DO?
THE EARLY VIEW, 10, 15 YEARS
AGO, WAS THAT, YOU KNOW, YOU
SHOULD ONLY RETURN THINGS WHEN
YOU ACTIVELY GET THEM TO CHECK
THE BOX THAT SAYS YES, AND YOU
HAVE TO EXPLAIN THAT THEY HAVE A
RIGHT NOT TO KNOW AND YOU HAVE
TO GET THEM TO ACTIVELY SAY YES.
ABOUT 10 YEARS AGO, THERE WAS
THIS BIG BROUHAHA WHEN THE
AMERICAN COLLEGE OF MEDICAL
GENETICS AND GENOMICS BASICALLY
SAID NO, YOU DON'T HAVE TO ASK
PEOPLE, IT'S FINE IF YOU JUST
TELL THEM THE DEFAULT IS TO
RETURN THESE FINDINGS.
NOW I SHOULD BE CLEAR HERE,
THESE ARE FINDINGS THAT ARE
DIFFERENT THAN THE ONES WE'VE
BEEN TALKING ABOUT TODAY.
THESE ARE POTENTIALLY LIFE HIGH
PRESSURE SAVING KINDS OF
FINDINGS.
LIFE-SAVING KINDS OF FINDINGS,
THAT TELL YOU ABOUT A KIND OF
CANCER YOU NEED TO SCREEN FOR OR
IF YOU DON'T CATCH IT EARLY,
YOU'RE GOING TO DIE.
SO IT'S NOT EXACTLY LIKE THE --
YOUR WATER HAS A SLIGHTLY
ELEVATED KIND OF CONTAMINANT OR
SOMETHING LIKE THAT, WHICH IS
ALSO STILL VERY IMPORTANT BUT
NOT SORT OF THAT IMMEDIATELY
POTENTIALLY LIFE-SAVING KIND OF
INFORMATION.
SO THERE WAS A HUGE UPROAR WHEN
ACMG MADE THIS CLAIM AND THEY
EVENTUALLY WALKED IT BACK, IT'S
STILL AN OPEN QUESTION, HOW MUCH
PERMISSION YOU ACTIVELY NEED TO
SEEK FROM PARTICIPANTS.
GENERALLY GETTING CONSENT IS
OBVIOUSLY A GOOD THING, BUT THE
PROBLEM IS THAT SOMETIMES PEOPLE
ARE GOING TO MAKE A MISTAKE,
THEY'RE GOING TO NOT REALIZE
WHAT THEY'RE SAYING NO TO, AND
SO IF YOU ASK THE QUESTION,
THERE'S GOING TO BE SOME NUMBER
OF PEOPLE WHO MAKE A MISTAKE AND
SAY NO WHEN THEY REALLY MEANT
YES AND I'VE GOT SOME DATA THAT
BACK THIS UP, BUT ON THE OTHER
HAND, ASKING PEOPLE IS GENERALLY
A GOOD THING AND IT ENHANCES
THEIR AUTONOMY AND GIVES THEM AN
OPPORTUNITY TO MAKE A CHOICE.
AND SO -- I'M A SKEPTIC, I'M
HAPPY TO TALK ABOUT THAT IN THE
DISCUSSION, BUT FROM MY DATA,
WHAT I'VE SEEN IS THAT IF PEOPLE
SAY NO, SOME OF THEM REALLY MEAN
IT.
SOME OF THEM ARE LIKE, THEY'LL
SAY NO MULTIPLE TIMES, THEY'LL
COMPLETELY UNDERSTAND WHAT
THEY'RE SAYING NO TO.
BUT THE OTHER HALF OF THEM
CHANGE THEIR MIND REALLY EASILY.
YOU JUST GIVE THEM A LITTLE BIT
MORE INFORMATION, THEY
ACTUALLY -- WHEN YOU ASK THEM
WHAT THEY THOUGHT THEIR ORIGINAL
ANSWER WAS, THEY GET IT WRONG
75% OF THE TIME, SO SOME PEOPLE
ARE MAKING A MISTAKE WHEN YOU
ASK THE QUESTION ABOUT THE RIGHT
NOT TO KNOW.
AND SO THE REAL ISSUE IS A
NORMATIVE ONE, SHOULD WE ASK THE
QUESTION IF YOU DO, YOU ARE
EITHER -- YOU'RE GOING TO MAKE A
MISTAKE IN ONE DIRECTION OR THE
OTHER.
YOU'RE EITHER GOING TO ASK THE
QUESTION AND GET SOME GROUP OF
PEOPLE WHO SAY NO ACCIDENTALLY
AND THEN THEY'RE NOT GOING TO BE
ABLE TO GET THE INFORMATION THAT
THEY MIGHT OTHERWISE WOULD HAVE
WANTED, ARE OH YOU'RE GOING TO
BE PERHAPS IMPOSING INFORMATION
ON SOME GROUP OF PEOPLE WHO
WOULD HAVE PREFERRED NOT TO KNOW
IT.
SO IT'S A NORMATIVE QUESTION,
THERE'S NO RIGHT AND WRONG HERE,
BUT YOU HAVE TO UNDERSTAND WHAT
THE TENSION IS WHEN THINKING
ABOUT HOW TO CONSTRUCT THE
CONSENT FORM FOR PROGRAMS LIKE
THE ECHO CONSORTIUM AND DECIDE
WHETHER OR NOT THEY SHOULD
ACTIVELY ASK FOR CONSENT TO
RECEIVE PARTICULAR KINDS OF
FINDINGS.
SO JUST SOME OTHER POLICY
ISSUES.
WE'VE ALREADY TALKED A LITTLE
ABOUT RE-ANALYSIS, WHAT HAPPENS
IF THE SCIENCE CHANGES, DO YOU
HAVE TO GO BACK AND RE-ANALYZE,
OOR RE-CONTACT PEOPLE.
SOMETIMES WE HAVE SAMPLES THAT
ARE COLLECTED A LONG TIME AGO, I
DON'T THINK THIS IS AS RELEVANT
TO THE ECHO, AND ADAM TALKED
ABOUT CLIA, WHICH I WON'T GET
INTO BECAUSE I TRY TO -- I'M A
LAWYER BY TRAINING BUT I TRY TO
AVOID GETTING INTO CLIA AND
HIPAA AND ALL THE OTHER ACRONYMS
THAT HE TALKED ABOUT EARLIER.
SO WITH THAT, THANK YOU.
I'M REALLY LOOKING FORWARD TO
THE QUESTIONS AND THE DISCUSSION
LATER.
>>GREAT.
THANK YOU, BENJAMIN.
DO WE HAVE QUESTIONS?
JADINE?
>>DO YOU THINK THAT BASED OFF
ONE -- LIKE A ONE-TIME
CONTRIBUTION OR MULTIPLE
CONTRIBUS TO ASTUDY, DO YOU THIR
DECISION TO RELEASE THAT
INFORMATION, LIKE, BECAUSE YOU
SAID THE ONE TIME YOU PROBABLY
DON'T FEEL THE NEED TO DISCLOSE
THE INFORMATION.
DO YOU THINK THAT AFFECTS THE
INTEGRITY OF YOUR RESEARCH?
>>SO ANY TIME YOU'RE MAKING A
DECISION ABOUT THINGS THAT WILL
IMPACT WHETHER PEOPLE WILL WANT
TO SIGN UP, WHETHER YOU CAN
RETAIN THEM, I MEAN, YOU ALWAYS
HAVE TO THINK ABOUT THE
INTEGRITY OF THE RESEARCH.
WHAT I LIKE TO THINK ABOUT IN
TERMS OF ETHICAL OBLIGATIONS AND
THEN SORT OF WHAT'S PERMITTED.
I THINK RESEARCH SHOULD BE
RETURNING AS MUCH INFORMATION TO
PEOPLE AS THEY FE FEASIBLY CAN,
THAT PEOPLE WANT, THAT WILL
BENEFIT PEOPLE.
BUT NOT ALL RESEARCHERS THINK
THAT AND SO IT'S ALSO USEFUL TO
THINK ABOUT LIKE WHAT'S THE
FLOOR, WHAT'S THE MINIMUM THAT
THEY HAVE TO DO, AND SO THE
ARGUMENT THERE WAS FOR ONE-TIME
BLOOD DRAW KINDS OF STUDIES, THE
FLOOR IS GOING TO BE PRETTY LOW.
MAYBE THEY DON'T HAVE TO RETURN
INFORMATION.
THEY SHOULD, BUT YOU'RE RIGHT,
THEY SHOULD DEFINITELY THINK
CAREFULLY ABOUT HOW IT WILL
IMPACT THE RELATIONSHIP THEY'RE
BUILDING WITH THE COMMUNITY THAT
THEY'RE RECRUITING FROM, BECAUSE
THAT COULD IMPACT THE INTEGRITY
OF THEIR STUDY.
ANY OTHER QUESTIONS?
>>I'M JUST CURIOUS ABOUT IN THE
REFUSERS THAT YOU RUN ACROSS,
HAVE YOU DONE FOLLOW-UP?
>>WE'RE IN THE PROCESS OF
PLANNING THAT STUDY.
SO THAT'S RIGHT, SO YOU CAN ONLY
LEARN SO MUCH WITH A SURVEY.
WE'RE GOING TO DO AN IN-DEPTH
QUALITATIVE STUDY WITH THOSE
PARTICIPANTS TO LEARN MORE ABOUT
WHY THEY CHANGED THEIR MIND, WHY
THEY DIDN'T CHANGE THEIR MIND,
WHAT SORT OF REASONING THEY WERE
ENGAGING IN, BECAUSE, YEAH, YOU
CAN ONLY TELL SO MUCH THE STORY
WITH JUST THE NUMBERS.
>>HOW MUCH INFORMATION DO YOU
GIVE THEM AT THE TIME OF CONSENT
ABOUT THE RESULTS THAT THEY MAY
OR MAY NOT BE GETTING?
>>SO THAT'S A GREAT QUESTION,
AND THAT'S, I THINK, AN
IMPORTANT ONE FOR US TO THINK
THROUGH.
ON THE ONE HAND, I'VE SEEN
CONSENT FORMS WITH MULTIPLE
PAGES ABOUT JUST GENETIC RESULTS
OR JUST SPECIFIC KINDS OF
RESULTS.
CONSENT FORM ARE WAY TOO LONG AS
IT IS SO YOU REALLY DON'T WANT
TO OVERBURDEN PEOPLE, AND I
QUESTION THE ABILITY OF PEOPLE
WHO ARE SOMETIMES IN STRESSFUL
SITUATIONS, MAKING LOTS OF CHECK
BOX CHOICES THROUGH -- LIKE
THAT'S REALLY HARD.
THAT'S COGNITIVELY DIFFICULT.
BUT ON THE OTHER HAND, YOU DON'T
WANT TO JUST GIVE THEM ONE
SENTENCE THAT SAYS, WOULD YOU
LIKE MORE INFORMATION ABOUT
YOURSELF?
LIKE, THAT'S NOT ENOUGH.
AND SO IT IS A CHALLENGE TO FIND
A SWEET SPOT.
THE WAY I LIKE TO THINK ABOUT IT
IS SORT OF IN A PHASED OR
MODULAR WAY, LIKE, YOU GIVE THEM
ONE SHORT PARAGRAPH IN THE
CONSENT FORM, AND THEN YOU POINT
THEM TO MORE INFORMATION.
SO PEOPLE THAT WANT MORE
INFORMATION MAYBE WANT TO MAKE
MORE GRANULAR DECISIONS, THERE'S
A WAY SORT OF SEPARATE FROM THE
CONSENT FORM FOR THEM TO DO
THAT, BUT THE CONSENT FORM JUST
CONTAINS THE ONE PARAGRAPH THAT
PEOPLE NEED TO KNOW WITHOUT
GOING INTO A TON OF DETAIL.
BUT REASONABLE PEOPLE MIGHT
DISAGREE, SO I WOULD LOVE TO
HEAR OTHER PEOPLE'S VIEWS WHEN
WE GET INTO THE DISCUSSION.
INGRID.
>>WHEN YOU -- AS A RESEARCHER
WHO HAS INFORMATION ABOUT
SOMEBODY THAT THEY FEEL IS
IMPORTANT TO THEIR HEALTH AND
THEN NOT BEING ABLE TO GIVE IT
BACK TO THEM?
>>SO SOMETIMES I CALL THAT THE
"I CAN'T SLEEP AT NIGHT"
PROBLEM.
I'VE DEFINITELY HAD CONSULTS
WITH INVESTIGATORS WHO HAVE
INFORMATION.
THAT'S THE PROBLEM WITH A BARE
BONES CHECK BOX, BECAUSE SOMEONE
CHECKS NO AND YOU CAN'T -- YOU
CAN'T CALL THEM UP AND SAY, HEY,
WE FOUND OUT SOMETHING ABOUT UM,
WOULD YOU -- YOU SAID YOU DIDN'T
WANT TO KNOW, IS THAT TRUE?
AND THEY'LL SAY, WELL, WHAT KIND
OF THING IS IT?
YOU JUST CAN'T HAVE THAT
CONVERSATION WITHOUT REVEALING
MOST OF WHAT THEY DIDN'T WANT TO
KNOW IF THEY REALLY DIDN'T WANT
TO KNOW FLEURCHLT AND SO IT IS
HARD, IT CAN LEAD TO MORAL
DISTRESS.
I'VE ARGUED BEFORE THAT IT'S NOT
A MAJOR REASON TO BE SKEPTICAL
OF THEIR RIGHT NOT TO KNOW BUT
IT IS A REASON.
IT'S WHY I'M IN FAVOR OF MORE
LIKE DEFAULT, TELLING PEOPLE,
HERE'S THE KIND OF INFORMATION
WE'RE GOING TO RETURN TO YOU.
TALK TO US IF YOU DON'T WANT
THAT, AND LETTING PEOPLE SORT OF
OPT OUT, SOFT-OPT OUT SO THAT
YOU MINIMIZE THE CHANCE OF
SOMEONE CHECKING THE WRONG BOX,
AND MISSING OUT ON INFORMATION
THAT THEY REALLY WANTED AND
COULD HAVE USED, AND THEN HAVING
THE EYE CAN'T SLEEP AT NIGHT
PROBLEM BECAUSE THE INVESTIGATOR
HAS INFORMATION THEY THINK IS
IMPORTANT BUT HAS THIS CHECK BOX
THAT SAYS THEY SHOULDN'T GIVE IT
BACK.
>>THANK YOU, BENJAMIN.
>>THANKS.
>>NEXT WE'LL HEAR FROM ADRIANA.
>>GOOD AFTERNOON, EVERYONE.
MY NAME IS ADRIANA ARCIA, AND I
AM A PROFESSOR OF NURSING AT THE
UNIVERSITY OF SAN DIEGO.
RECENTLY MOVED OVER FROM
COLUMBIA UNIVERSITY.
SO IN THIS SESSION ABOUT
DETERMINING WHICH RESULTS TO
RETURN TO PARTICIPANTS, I'M
GOING TO FOCUS ON SELF-REPORTED
RESULTS.
AND THIS IS A LITTLE BIT
DIFFERENT BECAUSE WHEN PEOPLE
ARE GIVING YOU SELF-REPORTED
RESULTS, THEY KNOW WHAT THEY
TOLD YOU, RIGHT?
SO IT'S NOT LIKE THE MYSTERIES
OF THE GENOME.
THE BULK OF MY EXPERTISE IS IN
ACTUALLY HOW TO RETURN RESULTS
BUT IN THIS TALK, I'M GOING TO
APPLY WHAT I'VE LEARNED ABOUT
THAT TO INFORM WHICH RESULTS
WE'RE GOING TO CHOOSE TO RETURN.
AND AS A BIT OF BACKGROUND, MY
RESEARCH HAS BEEN FOCUSED ON
USING PARTICIPATORY DESIGN
METHODS TO DEVELOP TAILORED INFO
GRAPHICS TO HELP PEOPLE
COMPREHEND THEIR PERSONAL HEALTH
INFORMATION, ESPECIALLY IF THEY
HAVE LOW HEALTH LITERACY OR
LIMITED ENGLISH PROFICIENCY.
SO EVERYTHING WE DO IS ALWAYS IN
ENGLISH AND SPANISH BASED ON THE
COMMUNITIES I WORK IN.
NOW WE'RE GOING TO BE WORKING IN
CHINESE AND BANGLA SO THAT'S
GOING TO BE A NEW CHALLENGE
SINCE I DON'T SPEAK THOSE LANGE
WANLS BUT FOR EXAMPLE, WE TELL
SOMEBODY HERE IS YOUR BLOOD
PRESSURE, WHAT IS THAT NUMBER
AND WHY SHOULD YOU CARE?
SO ALTHOUGH SOME OF OUR WORK IS
INTENDED FOR CLINICAL USE OUR
ORIGINAL USE WAS TO RETURN
RESULTS TO PARTICIPANTS SO I'LL
BE ILLUSTRATING WITH A FUEL OF
THOSE EXAMPLES.
WE DEFINITELY -- WHEN WE STARTED
TO DO THIS, WE REALIZED, THERE
IS NOT LITERATURE OUT THERE TO
TELL US HOW TO SHOW SOMEONE
THEIR BLOOD PRESSURE, AND THAT'S
REALLY HOW WE GOT STARTED ON
THIS RESEARCH JOURNEY.
SO THE FIRST THING IS, I'M GOING
TO MAKE THREE KEY POINTS.
NOW IT'S NOT WORKING.
THE FIRST ONE IS KIND OF
OBVIOUS, BUT YOU WANT TO MAKE
SURE THAT YOU HAVE A CLEAR AND
ONGOING RELEVANCE TO HEALTH.
SO YOU MIGHT HAVE INSTANCES IN
WHICH IT'S NOT OBVIOUS TO THE
PARTICIPANT WHAT THE RELEVANCE
IS TO HEALTH.
FOR INSTANCE, THEIR PROXIMITY TO
A TRUCKING ROUTE AND THEIR
ASTHMA, THEY'RE GOING TO SAY WHY
ARE THOSE THINGS RELATED?
THEREFORE YOU WANT TO SELECT
VARIABLES FOR WHICH YOU CAN GIVE
CLEAR EXPLANATIONS FOR THEIR
RELATIONSHIP TO HEALTH.
NOW THERE'S GOING TO BE SOME
SELF-REPORTED DATA WHERE THE
RELEVANCE TO HEALTH MIGHT BE
CLEAR, BUT IT'S NOT ONGOING.
SO UNSTABLE CHARACTERISTICS LIKE
YOUR CURRENT MOOD OR HOW HUNGRY
YOU ARE RIGHT THIS MINUTE, THOSE
THINGS ARE VERY HIGHLY VARIABLE,
AND THEY HAVE -- OR LIKE THE
TIMING OF YOUR LAST CIGARETTE OR
THE CUP OF COFFEE, THEY HAVE A
VERY SHORT SHELF LIFE.
SO UNLESS YOU CAN RETURN
SOMETHING ALMOST IMMEDIATELY,
IT'S LIKELY GOING TO BE
UNSUITABLE.
THE SECOND KEY POINT IS THAT WE
WANT TO BE ABLE TO CONTEXTUALIZE
THE RESULTS WE GIVE PARTICIPANTS
BECAUSE THEY'RE SELF-REPORTED SO
THEY ALREADY KNOW WHAT THEY TOLD
US, SO WE'RE ONLY REALLY ADDING
VALUE IF WE'RE CONTEXTUALIZING.
SO ON THE RIGHT IS AN EXAMPLE OF
AN INFOGRAPHIC FOR A CDC 30-DAY
MEASURE, WHICH IS -- THE
QUESTION IS OVER THE LAST 30
DAYS, HOW MANY DAYS WERE YOU
WORRIED, TENSE OR ANXIOUS?
AND WE'RE SHOWING THE INDIVIDUAL
PARTICIPANT THEIR RESULT ON THE
LEFT COMPARED TO THE COHORT MEAN
ON THE RIGHT.
AND THE COMPARISON DOES PROVIDE
SOME CONTEXT.
IT'S OBVIOUS THAT SEVEN DAYS IS
WORSE THAN FIVE.
BUT IS THERE A MEANINGFUL
DIFFERENCE BETWEEN -- OH, SORRY.
IS THERE A MEANINGFUL DIFFERENCE
BETWEEN THOSE TWO?
IS FIVE OKAY?
HOW MANY DAYS IS TOO MANY?
WITHOUT THAT CONTEXTUAL
INFORMATION, IT'S REALLY HARD TO
KNOW HOW TO FEEL ABOUT THIS.
SO THEREFORE, WHENEVER POSSIBLE,
WE WANT TO CHOOSE RESULTS FOR
WHICH THAT KIND OF CONTEXTUAL
INFORMATION IS AVAILABLE.
LIKE VALUE JUDGMENTS, IS THIS
VALUE GOOD OR BAD?
RECOMMENDATIONS, REFERENCE
RANGES, YOU KNOW, IF IT'S LOW,
MEDIUM OR HIGH, THRESHOLDS,
COHORT MEANS, POPULATION MEANS,
ALL OF THOSE CAN BE VERY HELPFUL
IN THIS REGARD.
SO IF YOU'RE STILL DECIDING
WHICH SELF-REPORTED MEASURES
YOU'RE GOING TO COLLECT, ONE
THAT YOU CAN LOOK AT, THERE'S A
DATA BANK OF MEASURES CALLED THE
PROMIS MEASURES, THE
PATIENT-REPORTED OUTCOMES
MEASUREMENT INFORMATION SYSTEM,
AND THESE ALL USE A POPULATION
MEAN OF 50, THE T SCORE.
POPULATION MEAN OF 50 AND T
SCORE OF 10.
THE PHENX TOOLKIT DOESN'T HAVE
THE SAME KIND OF STANDARDIZATION
BUT THERE ARE STILL A LOT OF
HIGH QUALITY MEASURES IN THERE.
AND PEOPLE ARE LIKELY TO ASSUME
THAT THE INFORMATION YOU RETURN
TO THEM IS IMPORTANT AND
ACTIONABLE.
YOU'RE NOT GOING TO TELL THEM
SOMETHING THAT IS IRRELEVANT TO
THEM.
SO WHENEVER POSSIBLE, YOU CAN
SELECT RESULTS THAT CAN BE
PAIRED WITH HEALTH PROMOTING
NEXT STEPS.
WE HEARD THAT LOUD AND CLEAR
FROM OUR PANEL THIS AFTERNOON,
THAT WE WANT TO NOAF WHAT SHOULD
I DO ABOUT THIS NEXT.
SO IN THIS EXAMPLE WEE GIVING
PEOPLE THEIR RESULT FOR THEIR
MINUTES OF MODERATE PHYSICAL
ACTIVITY FOR THE WEEK ALONG WITH
THE COHORT AND THE CDC
RECOMMENDATION FOR THAT
PARTICULAR MEASURE.
WE'RE GOING TO TALK ABOUT FUTURE
RESEARCH AND NEXT STEPS, THREE
DIFFERENT POINTS ABOUT THAT.
THERE MAY BE INSTANCES WHEN THE
RESULTS PRESENTED TO THE
RESEARCH PARTICIPANT CONFLICT
WITH THEIR SELF-IMAGE.
FOR INSTANCE, IF WE SAY YOUR BMI
IS CLASSIFIED AS OVERWEIGHT
INSTEAD OF HEALTHY OR SOMEONE
FEELS THAT THEIR ASTHMA IS UNDER
CONTROL AND WE'RE TELLING THEM
THAT IT'S NOT.
IN MY RESEARCH, I STARTED TO
WONDER, WHAT HAPPENS IN THESE
SITUATIONS?
IF THERE'S SUFFICIENT COGNITIVE
DISSIDENCE, DOES IT AFFECT
COMPREHENSION?
LIKE THIS DOESN'T PAN OUT, THIS
DOESN'T TRACK, I DON'T
UNDERSTAND IT, OR THEY BLOCK IT
OUT, DOES THAT AFFECT THE
CREDIBILITY OF THE MESSAGE?
AND SUBSEQUENTLY THE
PARTICIPANT'S TRUST IN THE TEAM
OR THE RESEARCH?
WHAT EFFECT MIGHT IT HAVE OR NOT
HAVE ON PEOPLE'S SELF MANAGEMENT
ACTIONS?
THESE ARE ALL UNANSWERED
QUESTIONS THAT I'VE NOT HAD THE
OPPORTUNITY YET TO PURSUE, SO I
DON'T THINK WE HAVE A CLEAR
ANSWER YET.
IN LIGHT OF THAT, IF WE'RE
SPOILED FOR CHOICE, AND WE
REALLY HAVE LOTS OF RESULTS TO
RETURN TO CHOOSE FROM, THEN WE
MIGHT REALLY THINK ABOUT WHICH
ONES MIGHT BRING UP THIS ISSUE.
AND MAYBE WE STEER CLEAR OF
THOSE UNTIL WE HAVE A BETTER
IDEA OF WHAT EFFECT THAT COULD
ACTUALLY HAVE ON PEOPLE.
ANOTHER UNANSWERED QUESTION FOR
ME IS WHEN AND WHY DO PEOPLE
READ TITLES AND WHEN DON'T THEY?
SO THERE'S SOME RESEARCH TO
SUGGEST THAT VIEWERS OF
VISUALIZATION SUCH AS CHARTS OR
INFO GRAPHICS RELY VERY HEAVILY
ON TITLES.
HOWEVER, IN OUR RESEARCH, WE
REPEATEDLY OBSERVED PARTICIPANTS
SYSTEMATICALLY SKIPPING TITLES.
IT HAPPENED SO MUCH THAT WE
STARTED CALLING IT TITLE
NEGLECT.
NOW, I HAVE SOME HYPOTHESES
ABOUT WHY THAT MIGHT BE.
SO THIS ASTHMA INFOGRAPHIC IS
PROBABLY INTERPRETABLE WITHOUT
THE TITLE.
IF YOU COVERED UP THE TITLE
YOU'D STILL GET THE GIST OF THE
MESSAGE.
BUT IF YOU HAVE SOMETHING LIKE A
STANDARD LINE CHART OR BAR
CHART, YOU HAVE TO READ THE
TITLE OR ELSE YOU DON'T KNOW
WHAT THE TOPIC IS.
SO I THINK THERE MIGHT BE MORE
TO THE STORY THAN PEOPLE RELY ON
THEM OR THEY DON'T.
SO I'M GOING TO SHOW YOU AN
EXTREME EXAMPLE.
THIS IS THE ACTUAL PAGE I
SHOWED, I ASKED HER IF HER BMI
WAS OVERWEIGHT, UNDER WEIGHT OR
OBESE AND SHE COULD NOT TELL ME.
SHE THOUGHT IT WAS NORMAL
BECAUSE SHE DIDN'T THINK SHE WAS
OVERWEIGHT BUT SHE COULDN'T
ACTUALLY FIND HER BMI.
I ASKED HER TO READ ME THE TOP
LINE OF THE PAGE AND SHE READ,
BODY MASS INDEX USES YOUR HEAT
AND WEIGHT.
SHE COULDN'T SEE THAT HER BMI
WAS 23.9 BECAUSE SHE'D BEEN
SYSTEMATICALLY SKIPPING THE
FIRST LINE, ASSUMING IT WAS
UNIMPORTANT, I SUPPOSE.
SO EVEN THOUGH IT'S NOT
FORMATTED DIFFERENTLY FROM THE
REST OF THE TEXT, I THINK IT'S A
FASCINATING PHENOMENON.
I WANT TO KNOW, DID ANYBODY ELSE
SKIP IT?
YEAH.
AND SO WE DON'T KNOW, IS THIS --
SORRY, LET ME GO TO THE NEXT
SLIDE.
SO UNTIL WE DO EYE TRACKING
STUDIES, WE REALLY WON'T KNOW IF
TITLE N NEGLECT -- IS IT ABOUT
DESIGN FEATURES, FORMATTING.
IF IT'S ABOUT FORMATTING, WHAT
ASPECTS OF IT?
IS IT ABOUT THE VIEWER'S
PERSONALITY OR HOW THEY'VE BEEN
EDUCATED?
WE DON'T KNOW ANY OF THESE
QUESTIONS.
SO IN THE MEANTIME, WHEN WE'RE
THINKING ABOUT WHICH RESULTS TO
RETURN, WE MIGHT CONSIDER WHAT
KINDS OF CONCLUSIONS PEOPLE MY
MITE JUMP TO IF THEY INDEED SKIP
THE TITLE.
AND IS THAT GOING TO BE A
THREAT, A REAL THREAT TO
INTERPRETATION.
SO THAT'S SOMETHING TO KEEP IN
MIND.
THEN MY LAST NEXT STEP IS A
PLEA.
WE REALLY NEED CENTRALIZED
REPOSITORIES TO BE ABLE TO SHARE
OUR MATERIALS WITH EACH OTHER SO
THAT WE'RE NOT REINVENTING THE
WHEEL.
EVERYTHING THAT I'VE SHOWN YOU
REMEMBER WAS INCREDIBLY
RESOURCE-INTENSIVE TO CREATE
TONKREE ANDDO DESIGN, DEVELOP A.
MY TEAM IS WORKING ON AN ONLINE
TOOLBOX THAT WILL BE CALLED THE
TAYLORIS -- LIKE THE ONES I'VE
BEEN SHOWING YOU, BUT IT STILL
UNDER DEVELOPMENT.
AND IN ANY CASE, WHEN SUCH A
REPOSITORY DOES COME ABOUT, IF
YOU'RE ALREADY AWARE OF HIGH
QUALITY RESOURCES, CONSIDER
CHOOSING VARIABLES THAT MATCH
THOSE EXISTING MATERIALS RATHER
THAN TAKING SOMETHING THAT'S
SIMILAR BUT NOT QUITE THE SAME
THAT DOESN'T QUITE MATCH WITH
WHAT'S AVAILABLE.
SO YOU'RE TAKING ADVANTAGE OF
THE WORK THAT PEOPLE HAVE
ALREADY DONE.
I HAVE TWO PRACTICAL
RECOMMENDATIONS.
THE FIRST IS CONSISTENT SCALING.
IF YOU PLAN ON SHOWING MORE THAN
ONE MEASURE, IT'S VERY, VERY
HELPFUL IF THE SCALING IS
CONSISTENT.
WHAT DO I MEAN BY THAT?
SO IN THIS EXAMPLE, HIGHER IS
BETTER.
ZERO IS THE WORST AT 100 IS THE
BEST.
BUT IN THIS EXAMPLE, HIGHER
NUMBERS INDICATE WORSE
PSYCHOLOGICAL DISTRESS.
AND THIS CAN BE VERY CONFUSING
FOR VIEWERS BECAUSE YOU HAVE TO
CHANGE GEARS IN THE MIDDLE OF
IT.
AND SO THERE ARE TIMES WHEN IT'S
UNAVOIDABLE, THAT YOU HAVE TO
PRESENT VARIABLES WITH OPPOSITE
SCALING.
A GOOD EXAMPLE IS VIRAL LOAD AND
CD4 COUNT.
YOU WANT VIRAL LOAD TO BE LOW
AND CD4 COUNT TO BE HIGH.
BUT IF YOU HAVE TO DO IT, THEN
YOU NEED TO CLEARLY SIGNAL TO
THE VIEWER THAT YOU'RE CHANGING
GEARS AND THAT YOU'RE SWITCHING
THE SCALING.
IF YOU HAVE THE LUXURY OF CLOIS,
THEN CONSIDER SELECTING RESULTS
THAT ARE ALL SCALED IN THE SAME
DIRECTION.
SO DON'T DO THIS.
MY LAST PRACTICAL RECOMMENDATION
IS TO SELECT FOR A COHESIVE
STORY.
WHAT DO I MEAN BY THAT?
I'M GOING TO SHOW YOU SOME
EXAMPLES FROM OUR VERY FIRST
PARTICIPATORY DESIGN STUDY OF
TAILORED INFO GRAPHICS.
INCIDENTALLY THESE ARE NOT GOOD,
YOU SHOULD NOT USE THEM.
SO FIRST WE SHOWED MARIA'S FRUIT
SERVINGS PER WEEK ALONG AL QAEDA
SIDE THE COHORT MEAN AND THE
RECOMMENDATION.
THIS WAS SIMULATED DATA.
SO EVERYONE IN OUR DESIGN
SESSIONS WAS LOOKING AT THE SAME
THING.
THEN WE SHOWED MARIA'S DAYS OF
EXERCISE PER WEEK.
SO FAR SO GOOD.
BUT WHEN WE GOT TO HERE, PEOPLE
COULD JUST NOT -- THEY COULD NOT
DEAL.
THEY COULD NOT ACCEPT THAT MARIA
WAS OVERWEIGHT BECAUSE THEY
ALREADY KNEW THAT SHE ATE FRUITS
AND VEGETABLES AND EXERCISED AND
CLEARLY THESE THINGS COULD NOT
ALL COEXIST, AND BE TRUE AT THE
SAME TIME.
SO OUR PARTICIPANTS HAD BUILT AN
ENTIRE NARRATIVE AROUND MARIA.
THEY TOLD ME SHE WAS AN
EDUCATOR, SHE DID GOOD THINGS
FOR HER COMMUNITY, THEY BUILT
THIS WHOLE STORY ABOUT MARIA AND
THAT WASN'T OUR INTENT.
WE WEREN'T WANTING FOR PEOPLE
TO, LIKE, LINK THESE THINGS
TOGETHER.
WE ENDED UP HAVING TO PUT
DIFFERENT NAMES ON EACH GRAPHIC.
BUT HUMANS ARE SO GEARED TOWARDS
PATTERN RECOGNITION AND
CONNECTING THE DOTS THAT IN
RETROSPECT, WE SHOULD HAVE
ANTICIPATED THIS WOULD HAPPEN.
SO WHEN YOU CAN -- SORRY, LET ME
FIND -- THERE WE GO.
WE DON'T WANT THE SITUATION WHEN
THAT'S NOT THE CASE, WHEN THINGS
DON'T GO TOGETHER, BUT YOU CAN
LEVERAGE THIS TENDENCY TO YOUR
OWN ENDS IF YOU'RE THOUGHTFUL
ABOUT SELECTING RESULTS THAT DO
PLAY WELL TOGETHER AND MAKE A
COHESIVE HEALTH PROMOTION STORY.
SO WITH THAT, I'LL TAKE
QUESTIONS.
>>
>>SO YOUR RESEARCH IS MAINLY
BASED AROUND SELF-REPORTED DATA?
>>YES.
>>SO HOW MUCH OF THAT DATA CAN
YOU VALIDATE?
OR CAN YOU VALIDATE ANY OF IT?
>>RIGHT.
SO IF PEOPLE ARE TELLING US, YOU
KNOW, HOW MANY FRUIT SERVINGS
PER WEEK, WE CAN'T BASICALLY.
A LOT OF THESE THINGS ARE
COMMUNITY SURVEYS, FOR INSTANCE,
THAT FIRST STUDY WAS A LARGE
COMMUNITY SURVEY, ALMOST 6,000
PEOPLE, WE CAN'T VALIDATE THAT.
SO WE'RE JUST TAKING PEOPLE'S
WORD FOR IT.
YOU KNOW, WHEN WE GO THROUGH AND
CLEAN THE DATA, WE LOOK AND SEE,
IS SOMEBODY GIVING US SOMETHING
THAT IS CLEARLY WRONG, YOU KNOW,
THEY'RE TELLING US THEY'RE
10 FEET TALL, ALTHOUGH THE
HEIGHT WE MEASURED OURSELVES.
BUT, YOU KNOW, YOU DO HAVE TO
KIND OF TAKE THAT INTO ACCOUNT.
BUT ULTIMATELY, IN RESEARCH
SELF-REPORTED DATA ARE ONLY AS
GOOD HOW FAITHFUL THE
PARTICIPANT IS BEING TO THEIR
OWN MEMORY AND TO THEIR OWN
EXPERIENCE.
THANKS.
>>THIS ISN'T AS MUCH A QUESTION
AS IT IS A COMMENT, BUT I FIND
THE TITLE NEGLECT TO BE SUPER
INTERESTING BECAUSE I THINK IT
SPEAKS TO SO MANY WAYS OF HOW WE
COMMUNICATE WITH PEOPLE.
DO YOU HAVE EYE TRACKING STUDIES
PLANNED?
I THINK THAT'S SUCH A GREAT WAY
TO TACKLE THAT.
>>YEAH, I MEAN, I WOULD NEED A
COLLABORATOR.
SO IF SOMEONE OUT THERE HAS EYE
TRACKING EXPERTISE, BECAUSE EYE
TRACKING IS PRETTY COMPLICATED,
CONTACT ME, WE'LL DO SOMETHING
GREAT.
>>I FIND MYSELF DOING THE
OPPOSITE, I DON'T READ THE LAST
TWO LINES OF AN ARTICLE OR A
PAPER OR SOMETHING, I JUST
FIGURE -- I FIGURED IT OUT BY
THIS POINTMENT BUT THAT'S
NEITHER HERE NOR THERE.
I WANTED TO ASK ABOUT THE SELF
IMAGE AND THIS IDEA THAT WHEN
YOU GIVE SOMEONE INFORMATION
THAT DOESN'T COMPORT WITH THEIR
VIEW OF THEMSELVES, WHAT DOES IT
LOOK LIKE WHEN THEY REJECT IT?
DO THEY REJECT THE VALIDITY OF
THE INFORMATION, DO THEY START
QUESTIONING THEIR SELF-IMAGE, DO
WE NOT KNOW?
>>I DON'T KNOW.
>>OKAY.
>>I DON'T KNOW.
IF SOMEONE HAS DONE THAT
RESEARCH, I HAVEN'T HAD THE
CHANCE TO STUMBLE UPON IT, BUT
IT IS SOMETHING THAT I DID A
STUDY SHOWING PEOPLE THEIR LEVEL
OF HAAS MA CON ASTHMA CONTROL AT
THERE'S A POSSIBILITY, MY ASTHMA
IS UNDER CONTROL, WHY ARE YOU
TELLING ME IT'S NOT?
BUT IT WAS A VERY SMALL STUDY,
WE ONLY HAD 10 PARTICIPANTS, OH,
YEAH, IT TRACKS, MY HUSBAND'S
ASTHMA ISN'T UNDER CONTROL.
ALSO A CHARACTERISTIC THAT
SOMEONE CAN CONSIDER
UNFLATTERING, THERE IS A
POSSIBILITY THAT PEOPLE GO THIS
IS JUST WRONG.
YOU CAN SEE WHAT HAPPENED WITH
MARIA.
THEY COULD NOT ACCEPT THAT SHE
WAS OVERWEIGHT.
THAT'S WHAT ACTUALLY STARTED
THIS WHOLE LINE OF INQUIRY, THIS
WHOLE IDEA.
SO THAT'S ANOTHER STUDY I
HAVEN'T DONE YET.
>>WE HAVE A ZOOM QUESTION.
>>SO THIS IS FROM ONE OF THE
PARTICIPANTS ON ZOOM.
SO THANK YOU FOR A GREAT TALK.
WHEN COMPARATORS ARE SHOWN LIKE
HOW YOU COMPARE TO OTHERS IN
YOUR AGE GROUP, IS THERE ANY
ANXIETY OR DISTRUST AMONG
PARTICIPANTS WHEN THE RESULT IS
PERCEIVED AS BEING LESS IN SOME
WAY?
>>YOU KNOW, I CAN'T SPEAK TO
THAT SPECIFICALLY.
BECAUSE WE -- MY RESEARCH HAS
BEEN PRIMARILY ABOUT DESIGNING
THE STUFF RATHER THAN ACTUALLY
GIVING IT TO PEOPLE.
WE DID DO SOME COMMUNITY
SESSIONS WHERE WE GAVE PEOPLE
THEIR PACKETS AND WE HAD
RESEARCH STAFF AVAILABLE TO
ANSWER QUESTIONS ABOUT IT.
BUT AGAIN, WITH SELF-REPORTED
RESULTS, PEOPLE -- THEY HAVE
SOME IDEA ABOUT THEMSELVES AND
HOW THEY COMPARE TO OTHERS.
WE HAD PEOPLE WHO -- WE TRIED TO
DO A COMPREHENSION STUDY.
YOU SAW THAT TEXT SLIDE, AND
TRIED TO ASK PEOPLE
COMPREHENSION QUESTIONS ABOUT
THESE THINGS AND A LOT OF TIMES
PEOPLE WOULDN'T LOOK AT THE
INFOGRAPHIC.
THEY WOULD JUST SAY I THINK I'M
MORE DEPRESSED THAN OTHER WOMEN
MY AGE AND THEY'D JUST GIVE US
THEIR OPINION BUT THEN WE'D SAY
OKAY BUT WHAT DOES THE
INFOGRAPHIC SAY?
AND WE HAD A HARD TIME GETTING
THEM TO ANSWER QUESTIONS LIKE
THAT.
>>CLAY?
ANOTHER QUESTION FROM THE
AUDIENCE.
SOMEWHAT SIMILAR.
FOR COHESIVE STORIES WITH
RESULTS HOW DO YOU AVOID
REINFORCING -- THE DATA --
>>WE SAW INSTANCES IN WHICH
PEOPLE -- WE WOULD SHOW LIKE A
FRUIT OR VEGETABLE
RECOMMENDATION OR EXERCISE
RECOMMENDATION AND THEY WOULD
SAY, YEAH, BUT DOES THIS APPLY
TO OLDER PEOPLE?
OR, YOU KNOW, I DON'T KNOW IF
THIS APPLIES TO ME.
AND SO PART OF IT WAS THE
SOURCE, DOES THE SOURCE HAVE
CREDIBILITY.
IF IT'S COMING FROM THEIR OWN
DOCTOR, IF IT SAYS CDC
RECOMMENDATION, OR IF IT'S LIKE,
THIS IS THE RECOMMENDATION FOR
WOMEN YOUR AGE.
AND THEN PEOPLE GO, OH, OKAY,
BUT WE HEARD LOTS OF WIDELY
VARIED OPINIONS ABOUT HOW MUCH
FRUIT AND VEGETABLES PEOPLE
SHOULD EAT.
REALLY WIDELY VARIED.
PEOPLE HAD VERY, VERY STRONG
OPINIONS ABOUT THOSE THINGS.
SO I THINK SOMETIMES THAT'S
GOING TO BE AN UPHILL BATTLE.
IF PEOPLE REALLY HAVE A FIRM
IDEA OF THIS IS THE WAY IT
SHOULD BE, PUSHING AGAINST THAT
IN ANY WAY MIGHT NOT BE -- MIGHT
BE A NON-STARTER.
>>I THINK WE SHOULD MOVE ON TO
THE NEXT ONE.
THANK YOU SO MUCH, ADRIANA.
>>THANK YOU.
>>NEXT WE'LL HEAR FROM JULIE
SAPP.
>>HI, GOOD AFTERNOON.
IS THE GREEN LIGHT WORKING?
SUPER.
THANK YOU.
THANKS SO MUCH FOR THE
OPPORTUNITY TO SPEAK WITH YOU
TODAY.
LIKE BEN, I -- LIKE EVERYBODY,
I'M TRYING TO FIGURE OUT HOW TO
ADVANCE THE SLIDE.
I'M ALSO A FEDERAL GOVERNMENT
EMPLOYEE AND I HAVE NO OTHER
CONFLICTS TO DECLARE.
BUT I THINK THE OTHER IMPORTANT
PIECE TO MENTION HERE IS I'M
COMING AT THIS FROM THE
PERSPECTIVE OF BOTH BEING A
CLINICIAN, SO I RETURN LOTS OF
INDIVIDUAL RESEARCH RESULTS TO
PEOPLE IN THE NIEHS STUDY THAT
BEN MENTIONED BUT ALSO STUDY
THIS PROCESS.
SO I'M ALSO GOING TO START OFF
MY TALK BY FOCUSING ON A
SPECIFIC SET OF GENOMIC VARIANTS
THAT WE CALL SECONDARY VARIANTS,
AND BEN AND OTHERS HAVE
MENTIONED THESE AS WELL.
I THINK A MAJOR POINT I WANT TO
MAKE ON THIS SLIDE IS, EVEN
THOUGH A LOT OF MY TALK IS
FOCUSED EXCLUSIVELY ON GENOMIC
VARIANTS, I THINK THERE'S A
REALLY GOOD CASE TO KIND OF
REJECT AN ARGUMENT OF GENETIC
EXCEPTIONALISM.
I THINK THERE'S ACTUALLY LOTS OF
THINGS THAT WE CAN LEARN FROM
WHAT WE UNDERSTAND OUTCOMES TO
BE IN A POPULATION OF PEOPLE
WHO'VE LEARNED RESULTS THAT ARE
MAYBE NOT GENETIC BUT HAVE SOME
IMPORTANT SIMILARITIES BETWEEN
SOME OF THESE TYPES OF FINDINGS.
SO I'M GOING FOCUS ON THIS SET
OF HIGHLY MEDICALLY ACTIONABLE
FINDINGS.
THE AMERICAN COLLEGE OF GENETICS
AND GENOMICS DELINEATING THESE
FINDINGS AND I THINK ANOTHER
IMPORTANT CONSIDERATION HERE IS
THESE ARE WORTH THINKING ABOUT
POPOTENTIALLY FOR ECHO BECAUSE F
THE 39 DISORDERS THAT ARE
CURRENTLY ON THE LIST TO BE
RECOMMENDED FOR RETURN TO
INDIVIDUALS, 35 OF THOSE MAY
HAVE SOME SORT OF CHILDHOOD
ONSET.
SO WE'RE NOT JUST TALKING ABOUT
ADULT ONSET CONDITIONS HERE, BUT
AGAIN, THESE ARE THE TYPES OF
FINDINGS THAT IF YOU KNEW ABOUT
THEM, YOU COULD TAKE ACTION THAT
WOULD, YOU KNOW, HOPEFULLY SAVE
YOUR LIFE.
THAT'S ACTUALLY WHAT'S SHOWN
HERE.
SO IDEALLY WHAT WE WERE
OPERATING WHEN WE RETURN THESE
TYPES OF FINDINGS TO PEOPLE IS
THAT WE'RE GIVING THEM
OPPORTUNITIES TO CHANGE THEIR
HEALTHCARE SO THEY GET MORE
PERSONALIZED CARE THAT WE HOPE,
AGAIN, IMPROVES THEIR HEALTH
OUTCOMES, BUT WE ALSO THINK IT
WOULD BE GREAT IF THIS BENEFIT
COULD EX-TEND TO THEIR FAMILY
BECAUSE THESE ARE GENETIC
FINDINGS, THEY'RE MOSTLY
DOMINANT FINDINGS WHICH MEANS
THAT FIRST DEGREE RELATIVES ARE
AT A 50% CHANCE TO SHARE THAT
PARTICULAR VARIANT WITH THE
FIRST PERSON WHO GOT THE
VARIANT, SO THEIR FAMILY MEMBERS
MIGHT ALSO EXPERIENCE SOME
BENEFIT IF THEY INFORM THEIR
FAMILY MEMBERS.
I DON'T WANT TO BELABOR THE NEXT
SLIDES TOO MUCH, BUT I THINK
THAT WHEN WE THINK ABOUT THE
OUTCOMES THAT WE CAN EXPECT ONCE
PEOPLE RECEIVE THESE KINDS OF
FINDINGS, I WILL SAY THAT THE
RATIO OF DATA IN THE EMPIRICAL
LITERATURE ABOUT HOW PEOPLE
FEEL, WHAT THEIR ATTITUDES MIGHT
BE TOWARDS RECEIVING THESE
RESULTS, FAR OUTWEIGHS ANY OF
OUR OUTCOME DATA.
SO I THINK THAT'S AN IMPORTANT
CAVEAT, AND PROBABLY A MAJOR
POINT HERE, IS TO THINK THAT WE
NEED TO -- YOU KNOW, THAT'S A
RESEARCH GAP THAT WE'D REALLY
BENEFIT FROM IMPROVING.
AGAIN, I'M GOING TO SKIP OVER
THIS BECAUSE PRETTY MUCH EVERY
SINGLE PERSON HAS MENTIONED THIS
IDEA THAT WHEN WE QUERY PEOPLE
ABOUT WHETHER OR NOT THEY WANT
THESE KINDS OF FINDINGS, PEOPLE
TELL US THERE'S AN OVERWHELMING
PREFERENCE TO RECEIVE THIS KIND
OF INFORMATION, PEOPLE WILL SAY
THEY WANT EVERYTHING, PEOPLE
WILL SAY THAT THEY WANT THEIR
NORMAL DATA AND ALSO THEIR RAW
DATA.
A VERY SMALL MINORITY OF PEOPLE
WANT NO INFORMATION OR
INFORMATION THAT'S ONLY RELATED
TO THE PRIMARY REASON WHY THE
TESTING WAS DONE.
WHEN WE ASK PEOPLE WHY,
ESPECIALLY AS IT PERTAINS TO
GENOMIC DATA, THEY WILL SAY,
IT'S EMPOWERING, BECAUSE IT
COULD DO SOMETHING THAT COULD
HELP ME PREVENT DISEASE BECAUSE
IT COULD BE OF BENEFIT TO MYSELF
OR TO MY FAMILY, BUT PEOPLE ALSO
CITE THESE CONCEPTS THAT ARE
MAYBE MORE IN THE PERSONAL
UTILITY REALM SUCH AS I'M JUST
CURIOUS, I JUST WANT KNOW, OR
BECAUSE IT WILL ALLOW ME TO
ENGAGE IN SOME SORT OF SELF
EXPLORATION LIKE UNDERSTANDING
MY ANCESTRY OR SOMETHING LIKE
THAT.
WHEN YOU ASK PEOPLE AGAIN TO
KIND OF DELVE INTO THESE THINGS,
THEY WILL CITE CONCERNS SUCH AS
PRIVACY OR BURDEN OF KNOWLEDGE
THAT MIGHT ADVERSELY AFFECT
THEIR LIFE IN SOME WAY.
THESE ATTITUDES OR CONCERNS ARE
FACTORED IN BUT THEY DON'T
OVERRIDE THIS REALLY CLEAR
EXPRESSED PREFERENCE FOR
LEARNING THESE KINDS OF RESULTS
FROM BEING IN RESEARCH STUDIES.
SO I THINK WHEN WE COME BACK TO
OUR IDEAL PARADIGM OF WHAT
HAPPENS AFTER WE SHARE THIS
INFORMATION WITH PEOPLE, WE CAN
LOOK TO THE LITERATURE TO SEE TO
WHAT EXTENT DO THESE OUTCOMES OF
INTEREST TO US ACTUALLY HAPPEN.
AND OUR GROUP PUBLISHED A REVIEW
JUST ABOUT TWO YEARS AGO NOW,
WHERE WE LOOKED FOR EVIDENCE OF
ALL OF THESE DIFFERENT OUTCOMES
IN THE RESEARCH LITERATURE OVER
THE LAST 15 YEARS AND THE
CIRCLES THAT ARE SHOWN THERE ARE
PROPORTIONAL TO THE INDIVIDUAL
REPORTS THAT WE FOUND IN THE
LITERATURE AND SO YOU CAN JUST
SEE BY THE SIZE OF THE CIRCLE
THERE THAT WE KNOW MUCH MORE
ABOUT HOW THESE KINDS OF GENOMIC
FINDINGS ARE DISCLOSED TO PEOPLE
AND WHAT KINDS OF
RECOMMENDATIONS ARE MADE
COMPARED TO THE DEGREE TO WHICH
THESE ARE INDIVIDUALS THAT ARE
ACTUALLY ENGAGING IN
DISEASE-SPECIFIC EVALUATIONS
THAT RESULT IN THE KINDS OF LIFE
PRESERVERRING HEALTHCARE ACTIONS
THAT WE WOULD WANT THEM TO TAKE.
SO I THINK, AGAIN, THIS REALLY
SPEAKS TO JEFF'S POINT OF THE
TWO SIDES OF THE CLINICAL
UTILITY COIN, JUST BECAUSE
SOMETHING MAYBE HAS THE
POTENTIAL TO IMPROVE SOMEONE'S
HEALTH, DO THEY ACTUALLY TAKE
THE ACTIONS OR ARE THEY ABLE TO
TAKE THE ACTIONS THAT ACTUALLY
CAN RESULT IN THAT AS WELL
FLEURCHLT BUT WBUTWHEN WE LOOK F
INDIVIDUALS, I THINK THERE ARE A
COUPLE DATA POINT THAT WE CAN
LEARN.
A LOT OF INK HAS BEEN SPILLED
ABOUT THE POTENTIAL FOR
PSYCHOLOGICAL HARM WHEN YOU
SHARE GENOMIC DATA WITH
INDIVIDUALS, BUT I THINK THAT
WHEN YOU LOOK IN THE LITERATURE,
THERE'S JUST NOT A TON OF
EVIDENCE FOR THAT.
WHEN YOU ASK PEOPLE IN AN
OPEN-ENDED WAY WHAT KINDS OF
EMOTIONS DID YOU EXPERIENCE
AFTER YOU RECEIVED YOUR
FINDINGS, PEOPLE WILL
VOLUNTARILY, YOU KNOW, REPORT A
HUGE RANGE OF EMOTIONS, FROM
SURPRISE TO RELIEF, SADNESS IF
IT'S, AGAIN, SOMETHING THAT
CONFERS INCREASED RISK FOR A
HEALTH CONDITION.
BUT WHEN YOU EXPLICITLY ASK
PEOPLE, DID YOU -- DO YOU REA
GRET CHECKING THAT BOX THAT
ALLOWED YOU TO RECEIVE THESE
KINDS OF RESULTS OR SAYING YES
WHEN SOMEONE ASKED YOU WHETHER
OR NOT YOU MIGHT WANT TO, THIS
IS A FINDING THAT IS REPORTED IN
REALLY A VERY SMALL MINORITY OF
PARTICIPANTS.
SIMILARLY, WHEN WE DO
LONGITUDINAL MEASUREMENTS, AND
AGAIN, THERE'S NOT A TON OF DATA
ON THIS, BUT WHEN YOU LOOK AT
THINGS LIKE DEPRESSION AND
ANXIETY, THEY'RE KIND OF REALLY
UNCHANGED WHEN YOU LOOK AT THEM
IN A KIND OF PRE/POST WAY.
AND INDEED, SOME PEOPLE EVEN
FORGET THAT THESE HIGHLY
MEDICALLY ACTIONABLE FINDINGS
HAVE BEEN SHARED WITH THEM.
THERE ARE A COUPLE REPORTS IN
THE LITERATURE OF PEOPLE
APPROACHING INDIVIDUALS WHO'VE
RECEIVED THESE KINDS OF GENOMIC
FINDINGS FROM BEING IN A
RESEARCH STUDY AND THE
PARTICIPANT WILL SAY, YOU KNOW,
THANK YOU FOR REMINDING ME OF
THAT, I HAD TOTALLY FORGOTTEN
THAT SOMEONE HAD SHARED THAT
WITH ME.
SO I THINK, AGAIN, THE EVIDENCE
HERE IS LEANING TOWARDS THE LINE
OF THIS IS NOT SOMETHING THAT WE
SHOULD SIGNIFICANT RISK OF
ADVERSE PSYCHOLOGICAL OUTCOMES
IS REALLY NOT SOMETHING THAT
SEEMS TO BE BROADLY REPORTED.
SO ANOTHER DESIRED OUTCOME THAT
WE MIGHT WANT TO SEE FROM
INDIVIDUALS AFTER THEY RECEIVE
THESE KINDS OF FINDINGS IS THAT
THEY SHARE THEM WITH THEIR
FAMILY MEMBERS, AS I MENTIONED
EARLIER, AND WITH THEIR
PROVIDERS, SO THAT THEY CAN
TAYLOR THEIR HEALTHCARE.
AND WHEN THIS HAS BEEN MEASURED,
WE FOUND THAT HIGH NUMBERS OF
PEOPLE DO REPORT SHARING THESE
RESULTS WITH THEIR FAMILY,
ESPECIALLY CLOSE RELATIVES.
SOMETIMES PEOPLE DON'T SEEM TO
HAVE -- THERE'S NOT A LOT OF
EVIDENCE FOR STRATEGIC SHARING
IN TERMS OF DEGREE OF FAMILIAL
RELATIONSHIP, SO A LOT OF TIMES
PEOPLE WILL SAY, I SHARED THIS
INFORMATION WITH MY COUSIN.
WHY DID YOU SHARE IT WITH YOUR
COUSIN INSTEAD OF MAYBE YOUR
BROTHER OR SISTER?
BECAUSE I'M CLOSER WITH MY
COUSIN.
SO PEOPLE ARE NOT NECESSARILY
CONNECTING THAT THE HIGHEST
PRIORITY TO SHARE GENETIC
RESULTS WITH ARE THOSE YOU
PROBABLY SHARE THE GREATEST
NUMBER OF GENES WITH, LIKE YOUR
FIRST DEGREE RELATIVES.
THERE ARE MANY REPORTS OF PEOPLE
SHARING THIS INFORMATION WITH
PROVIDERS, LIKE THEIR PRIMARY
CARE PROVIDERS AND SPECIALISTS,
SO THIS IS COMMON, BUT NOT
UNIVERSAL.
SO IN THE STUDIES THAT HAVE
EXAMINED THIS PARTICULAR
OUTCOME, THE RATES OF DISCLOSURE
TO HEALTHCARE PROFESSIONALS
HOVER RIGHT AROUND 65 TO 70%.
SO THERE'S STILL A SIGNIFICANT
NUMBER OF PEOPLE WHO ARE NOT
SHARING THEIR FINDINGS WITH
THEIR -- WITH A HEALTHCARE
PROVIDER EVEN AFTER THEY LEARN
THEM.
AND THEN THIS LAST POINT THAT I
WANT TO EMPHASIZE, THIS IDEA
THAT THE ULTIMATE GOAL OF
SHARING THIS INFORMATION WITH
PEOPLE IS SO THAT THEY CAN
EXPERIENCE THE CLINICAL UTILITY
OF HAVING THIS INFORMATION.
YOU KNOW, AGAIN, I THINK THERE'S
SOME EVIDENCE TO SUGGEST THAT
PEOPLE ARE FOLLOWING
RECOMMENDATIONS THAT THEY GET,
BUT THERE'S A HUGE RANGE HERE.
SO IN SOME STUDIES, IT WILL BE
JUST OVER HALF OF PEOPLE HAVE
FOLLOWED UP WITH A SPECIALIST
THEY WERE RECOMMENDED TO SEE,
AND THEN OTHER STUDIES, IT'S
MUCH HIGHER.
SO I THINK THAT'S SOMETHING
THAT'S REALLY WORTH
UNDERSTANDING A LITTLE BIT MORE.
THERE ARE LOTS OF REPORTS OF
PEOPLE SEEKING GENETIC
COUNSELING AND SPECIALIST
REFERRALS.
AND IN THE VERY FEW STUDIES THAT
HAVE LOOKED AT COSTS OF HOW MUCH
DOES IT COST THE HEALTHCARE
SYSTEM TO RETURN THIS HIGHLY
MEDICALLY RELEVANT INFORMATION
TO PEOPLE, THE COSTS HAVE BEEN
EQUIVALENT OR LOWER THAN
EXPECTED.
I THINK WHEN I LOOK AT THESE
DATA, I THINK THERE IS TRENDING
IN A POSITIVE DIRECTION, BUT
AGAIN, WE WERE ONLY ABLE TO FIND
EVIDENCE OF THESE PRECISION
MEDICINE OUTCOMES LIKE SOMEONE'S
LIFE BEING SAVED, OR THEM
ALTERING THEIR HEALTHCARE IN A
REALLY IMPACTFUL WAY IN ABOUT 3%
OF THE REPORTS IN THE
LITERATURE.
SO WE STILL HAVE A WAYS TO GO
THERE.
NEVERTHELESS, IN THE LITERATURE
YOU WILL SEE REPORTS LIKE PEOPLE
TAKING MEDICINE TO -- OR
ALTERING SOME OF THEIR
MEDICATION PREFERENCES TO AVOID
A MALIGNANT ARRHYTHMIA, PEOPLE
RECEIVING TARGETED THERAPY TO
ADDRESS GENETIC CAUSES OF HIGH
CHOLESTEROL, EARLY
IDENTIFICATION OF CANCER RISK
LESIONS, AND THEN PROPHYLACTIC
SURGERIES TO PREVENT -- OR TO
DRAMATICALLY REDUCE CANCER RISK.
SO AGAIN, THESE REPORTS DO EXIST
IN THE LITERATURE.
SO I'LL CONCLUDE BY TALKING
ABOUT WHAT WE CAN UNDERSTAND
ABOUT DATA FROM HEALTHY
FAMILIES, SO THESE ARE PEOPLE
WHO ARE MAYBE MOST ANALOGOUS TO
ECHO PARTICIPANTS.
AND AGAIN, I THINK THEY'RE
REALLY VERY LIMITED DATA OUT
THERE AND THEY'RE LARGELY
THEORETICAL, SO WHEN YOU SURVEY
PEOPLE, YOU'LL SAY WHAT KINDS OF
RESULTS WOULD YOU LIKE TO
RECEIVE?
AND THEN AGAIN, I THINK THIS IS
DIFFERENT FROM ACTUALLY
FOLLOWING PEOPLE WHO HAVE
RECEIVED THESE KINDS OF RESULTS.
AND THEN I THINK ANOTHER CONCERN
WITH SOME OF THIS LITERATURE IS
THAT DISTINGUISHING FINDINGS
THAT MIGHT BE RELATED TO THE
PRIMARY RESEARCH OR THAT MIGHT
BE DIAGNOSTIC FROM SECONDARY
FINDINGS IS REALLY CHALLENGING
IN SOME OF THIS HYPOTHETICAL
WORK AND FROM SOME OF THE WORK
THAT'S BEEN DONE.
SO THERE'S ONE STUDY THAT
INVESTIGATED IN ADOLESCENTS WHO
HAD THE OPPORTUNITY TO RECEIVE
SECONDARY GENOMIC FINDINGS FROM
BEING IN A RESEARCH STUDY.
AND MANY OF THESE RESULTS WERE
PHARMACOGENOMIC, SO MAYBE LESS
CLINICAL UTILITY THAN WHAT I
JUST MENTIONED, HIGHLY IMPACTFUL
STUDIES.
BUT THE ADOLESCENTS THEMSELVES
REPORTED SOME DEGREE OF INITIAL
OVERWHELM, MOSTLY DUE TO THE
UNFAMILIARITY THEY EXPRESSED
ABOUT THESE TYPES OF FINDINGS,
BUT LATER ON, AFTER SOME TIME
HAD PASSED, THEY EXPRESSED
THINGS LIKE GRATITUDE BECAUSE IT
WOULD ALLOW THEM TO THINK ABOUT
HOW THEY WOULD MOVE FORWARD WITH
SOME OF THESE FINDINGS FOR
FAMILY PLANNING OR WHEN I GROW
UP, I KNOW NOW I NEED TO HAVE
SCREENING FOR THIS.
AND ALL OF THESE ADOLESCENTS
REPORTED THAT WHAT WE CALL
ADAPTATION, SO AGAIN, AFTER THIS
INITIAL PERIOD OF WOW, THAT WAS
A LOT OF INFORMATION, WHEN YOU
APPROACH THEM A COUPLE MONTHS
LATER, THEY SAY, WELL, THIS IS
REALLY FINE, AND IMPORTANTLY,
I'M SATISFIED.
I DON'T HAVE DECISIONAL REGRET,
I'M GLAD THAT I SIGNED UP TO
RECEIVE THOSE KINDS OF FINDINGS.
CHEN WTHEN WHEN YOU ASK PARENTS,
PARENTS MAKING DECISIONS ABOUT
WHETHER OR NOT THEY SHOULD
RECEIVE RESULTS ON BEHALF OF
THEIR CHILDREN, I THINK THE KEY
HERE IS THAT MANY TIMES WHEN YOU
ASK PARENTS ABOUT GETTING
INFORMATION ABOUT THEIR
CHILDREN, THIS WHOLE DISTINCTION
BETWEEN WHAT'S SECONDARY AND
WHAT'S RELATED TO THE RESEARCH
AND WHAT'S CLINICALLY USEFUL AND
WHAT'S A PERSONAL UTILITY, JUST
KIND OF EE VAN WAITS BECAUSE EVY
JUST WANT TO KNOW MORE ABOUT
THEIR KIDS.
SOME OF THESE DISTINCTIONS WE
MIGHT MAKE AGAIN ARE NOT AS
RELEVANT TO PARENTS.
THEY ESSENTIALLY SAY IF IT'S
SOMETHING THAT COULD HELP MY
CHILD, PLEASE TELL ME, I'M VERY
INTERESTED IN LEARNING ABOUT
THIS, AND THIS IS, AGAIN, WHERE
I THINK SOME OF THE GENETIC
EXCEPTIONALISM EVAPORATE.
THEY DON'T CARE THAT IT'S
GENETIC, THEY JUST CARE, CAN IT
HELP MY CHILD.
AND THENL THE OUT THEN THE OUTCT
PARENTS EXPERIENCE AFTER
LEARNING THESE KINDS OF FINDINGS
ARE I THINK CLOSELY LINKED TO
THEIR LIFE EXPERIENCES,
DEPENDING ON KIND OF THEIR
PREVIOUS EXPERIENCES THEY'VE HAD
WITH CARING FOR A CHILD WITH
SPECIAL NEEDS, FOR EXAMPLE, THEY
JUST ARE -- THEY CITE THEIR OWN
LIFE EXPERIENCE AND THEY THINK
ABOUT WHY THEY MIGHT WANT TO
LEARN MORE INFORMATION.
THEN THIS ONE STUDY DID LOOK AT
RECESSIVE AND CARRIER RESULTS IN
A LARGE POPULATION OF HEALTHY
PEOPLE.
AND I THINK THE KEY FINDING TO
POINT OUT HERE IS THAT OVERALL,
PEOPLE WERE VERY SATISFIED THAT
THEY OPTED IN TO LEARN THESE
RECESSIVE RESULTS.
BUT THE PEOPLE WHO EXPERIENCED
SOME LEVEL OF DISCOMFORT IN THIS
STUDY TENDED TO BE THE ONES WHO
WERE GRANDPARENTS BECAUSE THEY
WERE CONCERNED ABOUT THEIR
GRANDCHILDREN BEING AFFECTED
WITH A PARTICULAR GENETIC
DISEASE.
SO IN CONCLUSION, I THINK
GENOMIC INTERROGATION IS
CERTAINLY BECOMING MORE COMMON
IN RESEARCH STUDIES OF ALL KINDS
AND AS MANY HAVE MENTIONED HERE,
ROBUST CONSENT PROCEDURES ARE
REALLY NEEDED TO SPELL OUT WHAT
THE ARRAY OF CHOICES -- OR WHAT
THE ARRAY OF RESULTS ARE THAT
MAY BE IN THE BALLPARK TO BE
RETURNED TO PEOPLE TO
PARTICIPANTS AND THE TIMELINE
UNDER WHICH YOU WOULD DO THAT.
CERTAINLY AS OTHERS HAVE
MENTIONED, PLANNING AHEAD TO
THINK ABOUT HOW YOU CAN
PROSPECTIVELY BUILD IN
PROCEDURES KIND OF LIKE, AGAIN,
WHAT BEN MENTIONED, A
CENTRALIZED RESOURCE TO RETURN
THESE KINDS OF FINDINGS TO
PEOPLE.
I'M PART OF A CENTRALIZED
RESOURCE LIKE THAT.
I THINK IS LIKELY TO BE
BENEFICIAL WHEN DESIGNING THESE
KINDS OF STUDIES.
SO I HAVE MY ACKNOWLEDGMENTS
HERE AND IMPORTANTLY I CITED A
LOT OF LITERATURE AND THERE'S
THE LINK TO THE LIBRARY FOR
THAT.
SO THANK YOU.
>>THANK YOU, JULIE.
QUESTIONS?
JEFF.
>>THANKS SO MUCH FOR THIS.
WONDERING WHAT YOU MAKE OF A
SLIGHTLY DIFFERENT CONTEXT WHERE
THE OUTCOMES, I THINK MAY BE
MARKEDLY DIFFERENT.
SO YOU'RE DEALING WITH THINGS
LIKE SAY BRCA1, SIGNIFICANTLY
IMPACT CONDITIONS WITH AND
FINDING THE HIGH PERCENTAGE OF
PEOPLE WHO ACTUALLY WANT THAT
INFORMATION BACK.
BUT IF YOU LOOK AT FAMILIES IN
WHICH THERE'S A KNOWN BRCA1
MUTATION, AND PEOPLE ARE AT 50%
RISK, MY KNOWLEDGE OF THE
NUMBERS IS LARGE PROPORTIONS OF
THOSE PEOPLE DON'T WANT TESTING.
LIKE 50%.
AND I THINK IT'S ALSO TRUE FOR
THINGS LIKE HUNTINGTON'S, WHERE
80% OF PEOPLE DON'T WANT TO KNOW
THAT INFORMATION.
I WONDER WHAT YOU MAKE OF THAT
CONTRAST AND THOSE TWO SCENARIOS
OF TESTING KIND OF FOR THE SAME
THING BUT A LITTLE DIFFERENT
BACKGROUND.
>>SO I THINK THE DATA ON UPTAKE
OF DIAGNOSTIC TESTING AND AT
RISK FAMILIES, LIKE YOU SAID, IT
CAN BE ALL OVER THE PLACE AND I
THINK IT'S HIGHLY
POPULATION-DEPENDENT AS WELL AND
DISEASE-DEPENDENT AS WELL, SO I
THINK THAT THERE ARE -- IF YOU
LOOK AT RATES OF CASCADE TESTING
IN RELATIVES, YOU CAN FIND
STUDIES IN POPULATIONS WHERE
THERE'S AN 80, 90% UPTAKE RATE
OF CASCADE TESTING AMONG
RELATIVES, IN BRCA1 AND 2 WE
HAVE MUCH HIGHER UPTAKE AMONG
WOMEN, EVEN THOUGH ME -- MALE OF
CARRIERS ARE AT THE SAME RISK AS
WELL.
I THINK THAT ANOTHER KEY POINT
HERE IS THAT PEOPLE WHO ARE
MAKING DECISIONS TO UNDERGO
PREDICTIVE GENETIC TESTING IN
THE CONTEXT OF A KNOWN CONDITION
IN A FAMILY HAVE A VERY
DIFFERENT LIVED EXPERIENCE FROM
PEOPLE WHO MIGHT BE ASKED TO GET
KIND OF A HEADS UP ABOUT A
PREVENTABLE HEALTH RISK WITH
WHICH THEY HAVE NO PERSONAL
LIVED EXPERIENCE.
SO I THINK ON THE ONE HAND, IT'S
A FAR MORE NEBULOUS CHOICE TO
ASK PEOPLE, YOU KNOW, AS BEN WAS
MENTIONING WHEN YOU THINK ABOUT
CONSENTING PEOPLE, YOU CAN GO
INTO ALL THIS DETAIL ABOUT
HERE'S THE MENU OF RESULTS WHICH
YOU MIGHT RECEIVE, BUT I THINK
PEOPLE STILL ANCHOR THAT SO MUCH
IN THEIR PERSONAL EXPERIENCE AND
IF THEY DON'T HAVE PERSONAL
EXPERIENCE WITH THAT SPECIFIC
CONDITION OR THEY'RE NOT LINKING
TO THIS IDEA OF HEREDITY WHICH I
HEAR FROM PEOPLE ALL THE TIME, I
HEAR THIS ALL THE TIME, I KNEW
THAT -- I KNOW EVERYONE IN MY
FAMILY HAS HEART ATTACKS AND HAS
HIGH CHOLESTEROL, BUT I HAD NO
IDEA THERE WAS A GENE FOR THAT,
OR I HAD NO IDEA THAT WAS
GENETIC.
AND I THINK THERE'S A -- I THINK
PEOPLE STILL KIND OF HARKEN BACK
TO THEIR PERSONAL EXPERIENCE AND
THAT IS SOMETHING THAT IS
UNAVOIDABLE IN MANY, MANY WAYS.
AND IF YOU ASK PEOPLE, WOULD YOU
LIKE THE HEADS UP -- WHEN I WORK
WITH RESEARCH PARTICIPANTS, I
TYPICALLY PITCH THIS AS, YOU
KNOW, I MIGHT FIND OUT SOMETHING
ABOUT YOU THAT COULD -- THAT
WOULD MAKE ME GIVE YOU SOME
RECOMMENDATIONS FOR HOW TO
CHANGE YOUR HEALTHCARE TO, YOU
KNOW, OPTIMIZE YOUR OUTCOMES.
I WOULD LIKE TO SHARE THAT WITH
YOU BECAUSE IT MAKES ME VERY
UNCOMFORTABLE TO KNOW SOMETHING
LIKE THAT ABOUT YOU WITHOUT
SHARING IT WITH YOU, AND PEOPLE
ARE VERY QUICK TO ENDORSE THAT
STATEMENT.
BUT THEY'RE PROBABLY THINKING
ABOUT THINGS THAT THEY PERCEIVE
OF AS BEING GENETIC THAT MIGHT
BE TOTALLY DIFFERENT FROM WHAT'S
ON THE TABLE HERE.
>>QUICK QUESTION.
I'M FROM -- THE ECHO PROGRAM,
THANK YOU FOR A NICE TALK.
THERE ARE SOME CULTURAL
DIFFERENCES, ESPECIALLY I KNOW
BEING FROM INDIA, EVEN A VERY
SERIOUS DISEASE OF A PATIENT,
FAMILY MEMBERS DON'T WANT TO
EVEN TELL THEM WHEN THE
DIAGNOSIS COMES FROM THE DOCTOR,
ABOUT A LETHAL DISEASE, HE MAY
HAVE ONLY A MONTH MORE, WHY
SHOULD WE SPOIL HIS REMAINING
DAYS IN THIS WORLD?
ARE THERE ANY ETHNIC DIFFERENCES
IN THE WAY THAT THEY DON'T WANT
TO ACCEPT THESE GENETIC
FINDINGS, AND THEN ARE THERE
DIFFERENCES IN THE AGE OF THE
RECIPIENT, YOU KNOW, YOUNGER
VERSUS OLDER PEOPLE?
>>UNDOUBTEDLY THOSE KINDS OF
EFFECTS ARE REALLY IMPORTANT.
I THINK WITH RESPECT TO
SPECIFICALLY THIS QUESTION ABOUT
SECRET KEEPING AND PEOPLE NOT
HAVING A LOT OF POTENTIALLY
GREAT OR ACCURATE HEALTH
INFORMATION ABOUT THEIR
RELATIVES, POTENTIALLY DUE TO
CULTURAL OR DISTANCE
CONSIDERATIONS OR LANGUAGE
CONSIDERATIONS LIKE THAT, I
THINK THAT'S OFTEN USED AS A
POTENTIAL JUST TI FIGURES OR
BENEFIT OF SHARING THIS KIND OF
INFORMATION WITH PEOPLE BECAUSE
WE CAN'T NECESSARILY MAKE THE
ASSUMPTION THAT YOU KNOW
EVERYTHING ABOUT YOUR FAMILY'S
HEALTH HISTORY AND THAT THE
HEALTH HISTORY THAT YOU REPORT
MAYBE TO YOUR PRI PRIMARY CARE
PHYSICIAN MAY NOT BE ACCURATE IN
INNUMERABLE WAYS.
BUT I THINK CULTURAL AND
ATTITUDE -- I THINK THERE'S SO
MANY -- HUMANS ARE VERY, VERY
COMPLEX AND WE ABSOLUTELY KNOW
ABOUT LOTS AND LOTS OF FACTORS
THAT INFLUENCE HOW PEOPLE
APPROACH THIS KIND OF
INFORMATION AND HOW THEY VIEW
IT, HOW THEY CENTER IT IN
RELATIONSHIP WITH THEMSELVES AS
AN INDIVIDUAL BUT WITH
THEMSELVES AS PART OF, YOU KNOW,
DIFFERENT -- A COMMUNITY AS WELL
FOR SURE.
>>THANK YOU.
>>I'M JUST WONDERING, ADAM USED
THE TERM TODAY "ENVIRONMENTAL
COUNSELOR," AND I'M WONDERING AS
A GENETIC COUNSELOR WHAT YOU
THINK OF THIS TERM AND IDEA.
>>YOU KNOW, I WROTE THAT DOWN,
AND I PUT QUESTION MARK AFTER IT
BECAUSE I THINK IT'S A REALLY
INTERESTING AND PROVOCATIVE
IDEA.
I ADMIT TO BE COMPLETELY
TRANSPARENT, MY FIRST THOUGHT
HERE WAS, WELL, COULDN'T THE
PRIMARY CARE PROVIDER DO SOME OF
THAT?
AND THEN I RECOGNIZED HOW ABSURD
THAT IS, BECAUSE MY WHOLE
PROFESSION, I THINK EXISTS
LARGELY BECAUSE THE PRIMARY CARE
PROVIDER CAN'T, DOESN'T, DOESN'T
HAVE THE TIME, THERE'S SO MANY
INDIVIDUAL AND SYSTEMIC BARRIERS
TO THAT.
SO I MEAN, I THINK THAT'S REALLY
INTERESTING, AND I WONDER ABOUT
THE DEGREE TO WHICH SOMEONE WITH
THAT KIND OF EXPERTISE MIGHT
BECOME EVEN MORE IMPORTANT IN
THIS AGE OF WHERE WE ARE
MEASURING SO MANY THINGS ABOUT
OURSELVES AND DRAWING LOTS OF
CONCLUSIONS ABOUT OURSELVES,
BECAUSE PEOPLE ARE BEING
MARKETED TO, TO LEARN ABOUT ALL
OF THESE THINGS, RIGHT?
SO YOU CAN COMPILE THESE HOME
TESTS NOT JUST OF YOUR GENES
BUT, YOU KNOW, OF YOUR -- TO
MEASURE YOUR AIR QUALITY AND
THINGS LIKE THAT.
SO I THINK THAT MAYBE WHAT WE'RE
REALLY TALKING ABOUT HERE IS
THAT THERE'S JUST SOME EXPERTISE
AND NAVIGATION THAT'S JUST
LACKING FOR PEOPLE TO MAKE SENSE
OF HEALTH INFORMATION GENERAL
LITTLE.
>>THANK YOU, JULIE.
NEXT WE'LL HEAR FROM RACHEL.
>>HELLO, EVERYBODY.
THANK YOU FOR STICKING WITH IT.
TODAY I WANT TO TALK TO YOU A
LITTLE BIT ABOUT OUR EXPERIENCE
WITHIN ECHO IN TERMS OF TRYING
TO DEVELOP A POLICY FOR RESULTS
RETURN, AND THEN SOME OF THE
LESSONS LEARNED FROM THAT GOING
FORWARD AS ECHO THINKS ABOUT
DEVELOPING AND BUILDING UPON
THIS EARLY WORK OF OURS.
SO AS WE'VE TALKED ABOUT,
THERE'S A LOT OF MOTIVATION FOR
RESULTS RETURN ON THE PART OF
RESEARCHERS TO BETTER ENGAGE
STUDY PARTICIPANTS IN WAYS THAT
CAN DO THINGS LIKE IMPROVE
RETENTION, STRENGTHEN RESEARCH
ETHICS AND THEN THERE'S
OBVIOUSLY PARTICIPANT DESIRE TO
GET THEIR RESULTS AND I THINK WE
MADE CLEAR THAT DESPITE THOSE
UNCERTAINTIES, PEOPLE ARE
INTERESTED IN THE INFORMATION
FOR VARIOUS REASONS.
AND THERE'S MOUNTING CONSENSUS
AMONG RESEARCHERS, AND I WOULD
ARGUE ALSO MANY IRBs ABOUT THE
BENEFITS OF SHARING SCIENTIFIC
INFORMATION TO IMPROVE PUBLIC
HEALTH AND ENVIRONMENTAL HEALTH
LITERACY AMONG PARTICIPANTS.
SO THIS WAS DISCUSSED EARLIER
BUT I THINK A LOT OF US HAVE
BEEN TAKING OUR LEADS FROM THE
NATIONAL ACADEMY'S REPORT IN
THAT RETURNING RESULTS CAN
DEMONSTRATE RESPECT FOR
PARTICIPANTS, IMPROVE
TRANSPARENCY ABOUT THE RESEARCH
ENTERPRISE AND TRUST, BENEFITS
PARTICIPANTS AND ALSO I WOULD
ARGUE AND THE REPORT STATES THAT
ALSO BENEFIT INVESTIGATORS.
SO ECHO RETURN OF RESULTS TASK
FORCE DEVELOPED IN PART BECAUSE
THERE WAS -- THERE ARE COHORT
WITHIN ECHO THAT HAVE BEEN DOING
REPORTBACK AND MANY OF THEM ARE
IN THIS ROOM AND UNDERGOING --
HAVE PRESENTED OR WILL PRESENT,
WHO HAVE DONE REPORTBACK A LOT
FOR ENVIRONMENTAL HEALTH
EXPOSURES IN BIOMONITORRING AND
OTHER MEDIA.
AND SO THERE WAS MOUNT
INTERESTING IN WHAT WOULD IT
TAKE AND WHAT SHOULD ECHO'S
POLICY BE ABOUT REPORTBACK OR
RESULTS RETURN, AND WHAT
ELEMENTS OF WHAT THE DIFFERENT
PROTOCOLS AND DATA BEING
COLLECTED WITHIN ECHO SHOULD
POTENTIALLY BE CONSIDERED FOR
REPORTBACK.
SO OUR CHARGE WAS BASICALLY TO
DEVELOP POLICIES AND PROCESSES
FOR RETURNING ECHO RESULTS TO
INDIVIDUAL PARTICIPANTS.
VERY STRAIGHTFORWARD SENTENCE.
A LITTLE MORE COMPLICATED TO
IMPLEMENT.
SO WE EMERGED WITH SORT OF
GUIDING PRINCIPLES FOR HOW WE
WERE GOING TO ENGAGE
PARTICIPANTS OR FAMILIES,
COMMUNITIES IN THE PROCESS OF
RESULTS RETURN, AND THESE WERE
KIND OF THE BASIC PRINCIPLES
THAT DPIGUIDED OUR THINKING.
SO RECOGNITION OF PARTICIPANTS'
CONTRIBUTIONS TO RESEARCH
DESIGN, CONDUCT, OVERSIGHT AND
DISSEMINATION AND THAT WE WANT
TO DO THAT ENGAGEMENT AS MUCH AS
POSSIBLE.
PARTICIPANTS, WE ARE NOT JUST
SORT OF INDIVIDUAL ATOMS HERE
AND INFORMATION RECEPTACLES, AS
MONICA STATED, BUT ARE EMBEDDED
IN FAMILIES AND COMMUNITIES, SO
WE NEED TO BE THINKING ABOUT
THAT WHEN WE'RE ENGAGING THEM.
AND THERE SHOULD BE SUPPORT FOR
INVESTIGATORS IN BUILDING
INTERNAL AND COMMUNITY CAPACITY
TO ENHANCE THEIR ENGAGEMENT WITH
STUDY PARTICIPANTS.
AND THAT ECHO IN GENERAL SHOULD
BE TRANSPARENT AND TRUSTWORTHY,
SHARE RESULTS IN FORMATS AND
LANGUAGE THAT PEOPLE CAN
UNDERSTAND, AND THAT IS USEFUL,
AND ENGAGE IN DIALOGUE WITH
PARTICIPANT COMMUNITIES WHERE
RESEARCH IS BEING CONDUCTED.
SO OUR PROCESS WAS TO DEVELOP
THESE BASIC ELEMENTS.
ONE WAS AN INDIVIDUAL RETURN OF
RESEARCH RESULTS POLICY.
AND THE OTHER ONE WAS A RETURN
OF INDIVIDUAL RESULTS PROCESS.
AND WE DEVELOPED INDIVIDUAL
RETURN OF RESULTS CATEGORIZATION
TABLES, BOTH FOR THE PARENT
REPORT AND CHILD REPORT.
AND THEN ALSO WE COLLECTED THE
RESOURCES FROM COHORTS THAT WERE
ALREADY DOING REPORT BACK TO
SHARE WITH OTHER INTERESTED
COHORTS THAT WANTED TO DO THAT
WORK.
WE ALSO DEVELOPED A RETURN OF
AGGREGATE RESULTS POLICY, WHICH
I WILL NOT HAVE TIME TO TALK
ABOUT TODAY.
SO THE POLICY BASICALLY APPLIES
TO INDIVIDUAL RESULTS, IT'S KIND
OF AN OVERARCHING POLICY THAT
BASICALLY SAYS FINDINGS THAT
PRESENT IMMEDIATE RISK TO THE
PARTICIPANTS SHOULD BE HANDLED
ACCORDING TO THE GUIDELINES OF
ECHO'S MANUAL OF PROCEDURES.
SO -- AND THE OTHER SORT OF
PAWRL LEL WITHPARALLEL, IF THERT
RISK TO PARTICIPANTS OR OTHERS
WILL BE HANDLED PER COHORT
SPECIFIC PROCEDURES AND
REQUIREMENTS OF FEDERAL, STATE
AND LOCAL LAWS.
SO FOR EXAMPLE, IN CALIFORNIA,
IF WE WERE TO FIND A VERY HIGH
BLOOD LEAD LEVEL, WE WOULD HAVE
AN OBLIGATION UNDER THE
DEPARTMENT OF PUBLIC HEALTH
RULES TO RETURN THOSE RESULTS TO
THAT STUDY PARTICIPANT AND WORK
WITH THE HEALTH DEPARTMENT TO
INVESTIGATE THE SOURCE.
AND THEN PARTICIPANTS SHOULD
RETAIN THE RYAN RITE TO REFUSE
THE RETURN OF ANY SPECIFIC
INDIVIDUAL RESULTS OR ALL RETURN
OF INDIVIDUAL RESULTS.
SO OUR STANDARDS FOR RESULTS
RETURN THAT WE WERE ABLE TO GAIN
CONSENSUS ON WERE THAT RESULTS
SHOULD BE FRAMED BY THEIR
CONTEXT, AND SO AGAIN, THIS HAS
BEEN DISCUSSED EARLIER.
WHEREVER WE CAN PROVIDE
PUBLISHED EVIDENCE TO PROVIDE
CONTEXT TO THE NUMBERS OR ARE
COMPARING PARTICIPANTS WITH
OTHER PARTICIPANTS EITHER WITHIN
THEIR COHORT OR ECHO-WIDE,
COMPARING WITH BENCHMARKS IF
THEY'RE AVAILABLE IN THE CASE OF
ENVIRONMENTAL HEALTH DATA IF
THERE ARE REGULATORY BENCHMARKS
TO WHICH CAN BE COMPARED.
IRB OBVIOUSLY HAS TO APPROVE THE
PROTOCOL FOR RETURNING --
RESULTS RETURN AND WE NEED TO
HAVE A PROCESS IN PLACE ABOUT
HOW WE'RE GOING TO HANDLE
PARTICIPANT QUERIES.
THERE SHOULD BE A LIST OF
REFERRAL RESOURCES AVAILABLE FOR
CLINICALLY RELEVANT RESULTS OR
THAT MIGHT REQUIRE FOLLOW-UP.
RESULTS THAT ARE AVAILABLE
IMMEDIATELY AND THAT CAN BE
RETURNED IN SOME AVAILABLE
CONTEXTUAL WAY WHERE THE TEST
SHOULD BE RETURNED IMMEDIATELY.
THERE'S OTHER RESULTS OBVIOUSLY
THAT WE TALKED ABOUT THAT
REQUIRE A LOT OF TIME, LAB TESTS
FOR ENVIRONMENTAL CHEMICALS, FOR
EXAMPLE.
THESE CAN BE RETURNED
PERIODICALLY VIA DIFFERENT
METHODS THAT WERE DISCUSSED BY
OUR PARTICIPANTS.
LANGUAGE SHOULD BE APPROPRIATE
AND THAT RESULTS FOR A CHILD
PARTICIPANT SHOULD BE RETURNED
TO THE PARENT AND RESULTS FOR
PARTICIPANTS OVER 18 SHOULD BE
RETURNED DIRECTLY TO THEM.
SO THIS WAS THE HARD PART.
WE DEVELOPED BASICALLY AFTER A
LOT OF DELIBERATION AND I WOULD
ARGUE CONSTERNATION A TIERED
APPROACH FOR RETURNING RESULTS.
AND WE DEVELOPED THREE TIERS FOR
RESULTS RETURN BY THE DIFFERENT
DATA DOMAINS WITHIN ECHO, AND
THESE THREE TIERS WERE THINGS
THAT WERE REQUIRED TO BE
REPORTED BACK TO PARTICIPANTS,
THINGS THAT ARE RECOMMENDED TO
BE REPORTED BACK, AND THEN
THINGS THAT SHOULD NOT BE
RETURNED.
SO YOU CAN SEE THAT BASICALLY AT
THE END, THE CONSENSUS WAS THAT
NOTHING SHOULD BE REQUIRED.
13 DATA ELEMENTS WERE CONSIDERED
TO BE RECOMMENDED.
AND THEN OVERWHELMING LIMOS OF
THE DATA ELEMENTS WERE NOT --
RECOMMENDED TO NOT BE RETURNED.
AND THIS WAS A VERY DELIBERATIVE
PROCESS WITH A BUNCH OF HEALTH
OUT COME WORK GROUPS THAT
PROVIDED INPUT AS PART OF THIS
TIERED CATEGORIZATION PROCESS
FOR ESSENTIAL DATA ELEMENTS.
SO THE LESSONS LEARNED FROM THIS
PROCESS, ONE, WAS THAT WE
DERIVED AT LEAST A STARTING
POINT, I WOULD ARGUE A FLOOR OFR
CONSENSUS -- THAT WE CAN START
TO BUILD UPON.
WE DID SHARE EXISTING TEMPLATES
AND EXPERIENCES FROM THOSE
COHORTS THAT HAVE UNDERTAKEN
REPORTBACK SUCCESSFULLY FOR
THOSE PIs THAT ARE INTERESTED
IN UNDERTAKING REPORT BACK.
WE WERE FORTUNATE IN THAT WE
RECEIVED FUNDING FROM ECHO
THROUGH THE OPPORTUNITIES
INFRASTRUCTURE FUND, OIF, THAT
HAS SUPPORTED THE APPLICATION OF
THE JUDICIAL REPORTBACK
INTERFACE DERBI PLATFORM WHICH
WAS DEVELOPED BY JULIA BRODY AND
COLLEAGUES AT SILENT SPRING AND
WE USED THAT IN OUR COHORTS AND
CHEMICALS IN OUR BODIES IN
SAN FRANCISCO AND I-KIDS IN
URBANA AND THAT'S GOING TO BE
DISCUSSED TOMORROW SO THAT'S A
LITTLE PLUG FOR TOMORROW'S TALKS
BY ANNIE PADULA AND JULIA BRODY.
AND THE OTHER LESSON IS THAT
THERE'S A PAUCITY OF RESOURCES
AND CAPACITY BUILDING RIGHT NOW
FOR COHORT P.I.s TO TAKE AND
UNDERTAKE RESULTS RETURN WITHIN
ECHO, AND I THINK THAT'S WHY WE
HAD ZERO REQUIRED.
AND RELATIVELY FEW RECOMMENDED.
SO WHAT ARE THE LESSONS LEARNED.
I THINK WHILE RESEARCH AND
SCIENTIFIC DISKF DISCOVERY IS S,
PARTICIPANTS AND COMMUNITIES
WANT INFORMATION NOW AS IT
BECOMES AVAILABLE.
SO MANY OF US WHO HAVE WORKED ON
THIS AND EVALUATED OUR
PARTICIPANTS' REACTION TO
RESULTS RETURN, WE'D ARGUE THAT
RESULTS RETURN CAN ADVANCE KIND
OF WHAT I LIKE TO CALL THE THREE
Rs.
RIGOR, RELEVANCE AND REACH.
RIGOR MEANING THAT IT IMPROVES
PARTICIPANT ENGAGEMENT AND
RETENTION IN RESEARCH.
I THINK IT ALSO MAKES OUR
SCIENCE BETTER, AND I'M HAPPY TO
TALK ABOUT THAT IN THE Q & A.
RELEVANCE IN TERMS OF IT
ENCOURAGES US TO PROMOTE
ENVIRONMENTAL AND PUBLIC HEALTH
LITERACY FOR PARTICIPANTS AND I
THINK THAT'S A POINT THAT MONICA
MADE THIS MORNING.
THESE ARE HUGE SCIENTIFIC
LITERACY OPPORTUNITIES.
IF WE REALLY WANT TO PUT OUR
MONEY WHERE OUR MOUTH IS IN
TERMS OF DEMOCRATIZING THE
SCIENTIFIC ENTERPRISE, THIS IS A
HUGE PATHWAY TO GET THERE.
AND THEN REACH.
HOW CAN WE USE REPORTBACK TO
LEVERAGE SCIENTIFIC EVIDENCE TO
FACILITATE TIMELY INTERVENTIONS.
WHETHER THAT'S INDIVIDUAL
ACTIONS THAT PEOPLE CAN TAKE OR
LETTING PEOPLE KNOW ABOUT
COLLECTIVE ACTIONS.
AND ALSO LETTING PEOPLE KNOW
ABOUT, FOR EXAMPLE, IN THE CASE
OF ENVIRONMENTAL CHEMICAL
EXPOSURES, THERE'S SOME RESULTS
THAT YOU CAN'T DO ANYTHING
ABOUT, OKAY, AND I WOULD LIKE TO
TALK ABOUT THIS A LITTLE BIT
MORE IN THE Q & A AS WELL.
THEN THE ABILITY TO PROMOTE MORE
ENGAGEMENT WITH CLINICIANS AND
HEALTHCARE PROVIDERS, FOR
EXAMPLE, WITH SUPPORT FROM
ORGANIZATIONS LIKE THE PAHSHUS
THAT WAS MENTIONED THIS MORNING.
SO WHEN WE THINK ABOUT THIS
CHALLENGING TOPIC ABOUT WHAT
STUDY PARTICIPANTS CAN DO, AND
I'M TALKING ABOUT THIS FROM THE
CONTEXT OF ENVIRONMENTAL
CHEMICAL EXPOSURES, THIS IS A
HARD ONE.
IT'S NOT NECESSARILY
STRAIGHTFORWARD.
BECAUSE WE KNOW THAT CHEMICALS
COME FROM A LOT OF DIFFERENT
SOURCES, THEY DON'T NECESSARILY
LEAVE A CALLING CARD FROM WHERE
THEY CAME.
AND SOME OF THOSE CHEMICAL
EXPOSURES HAVE DIFFERENT
CHALLENGES IN TERMS OF HOW WE
CAN AVOID THEM AS INDIVIDUALS.
SO I TRIED TO PROVIDE THIS
SCHEMATIC, FOR EXAMPLE, OUTDOOR
SOURCES OF ENVIRONMENTAL
CHEMICAL EXPOSURES CAN BE VERY
HARD TO AVOID.
YOU CAN'T JUST UP AND MOVE.
SOME CONSUMER PRODUCTS AND
DRINKING WATER CONTAMINATION
SOURCES ARE VERY HARD TO AVOID.
FOR EXAMPLE, FLAME RETARDANTS
AND PFAS.
AND THEN THERE'S OTHER CONSUMER
PRODUCT EXPOSURES THAT MIGHT BE
EASIER TO AVOID.
IE, USE OF INDOOR PESTICIDES.
AND SO I THINK IN OUR REPORTBACK
PROTOCOLS, WE WANT TO SORT OF
EXPAND OUR IMAGINATION A LITTLE
BIT AND HELP PARTICIPANTS
DISTINGUISH BETWEEN THOSE THINGS
OVER WHICH WE MIGHT HAVE
INDIVIDUAL CONTROL AND THOSE
THINGS OVER WHICH WE MAY NOT
HAVE INDIVIDUAL CONTROL AND THAT
REQUIRE COLLECTIVE AND/OR POLICY
CHANGE, AND THEN THAT CAN BE
LIBERATING TOO.
WHEN YOU TELL SOMEBODY THAT I
FOUND A CHEMICAL IN YOU AND THIS
IS SOMETHING THAT IS FOUND IN
NEARLY 100% OF THE U.S.
POPULATION, THIS IS REALLY NOT
ABOUT YOU, THIS IS A SYSTEMIC
PROBLEM, THAT, IN FACT, CAN BE
KIND OF LIBERATING.
YOU DON'T HAVE TO FEEL HAD, YOU
DIDN'T DO ANYTHING WRONG.
THIS IS AN ISSUE THAT REQUIRES
COLLECTIVE ACTION.
SO FOR EXAMPLE, IN OUR DERBY
INTERFACE WHICH AGAIN WILL BE
TALKED ABOUT MORE TOMORROW, WE
PROVIDE KIND OF A DUAL
RECOMMENDATION APPROACH WHERE WE
PROVIDE INFORMATION ON
INDIVIDUAL ACTION THAT PEOPLE
CAN TAKE, BUT ALSO LETTING
PEOPLE KNOW WHERE THERE'S BEEN
SOME POLICY CHANGE THAT HAVE
RESULTED IN DECREASED EXPOSURES
IN THE POPULATION TO HELP
ENHANCE ENVIRONMENTAL HEALTH
LITERACY ABOUT DIFFERENT SOURCES
AND WHICH ONES ARE MORE AMENABLE
TO INDIVIDUAL CONTROL.
SO I WANT TO CLOSE WITH THINKING
ABOUT FRAME WORKS FOR HOW WE
THINK ABOUT PARTICIPANT
ENGAGEMENT IN RESULTS RETURN.
AND IF YOU LOOK AT THIS
SCHEMATIC ON THE LEFT, THIS HAS
BEEN SORT OF THE OLD WAY, AND
WE'RE SLOWLY STARTING TO MOVE
TOWARDS THE RIGHT.
YOUR RIGHT TOO.
AND AT THE VERY END, WE DIDN'T
REALLY THINK ABOUT TALKING TO
OUR PARTICIPANTS.
WE DIDN'T EVEN THINK ABOUT
RETURNING RESULTS.
AND NOW, WE'RE REALLY STARTING
TO THINK ABOUT HOW DO WE ENGAGE
OUR PARTICIPANTS AND GET THEIR
FEEDBACK IN TERMS OF HOW THEY
WANT THEIR RESULTS BACK, IN WHAT
WAY, WHAT ARE SOME MESSAGES THAT
ARE HELPFUL, AND THEN ON THE FAR
END, HOW DO WE THEN COME BACK TO
THEM WHEN WE'VE RETURNED RESULTS
TO EVALUATE HOW THEY ACTED UPON
IT, HOW THEY FELT, AND HOW WE
CAN MAKE RESULTS RETURN BETTER
GOING FORWARD.
THIS IS AN ITERATIVE PROCESS,
OKAY?
WE THINK ABOUT SOFTWARE PROGRAMS
THAT ARE IN BETA VERSION.
IF WE THINK ABOUT RESULTS RETURN
AS SOMETHING THAT'S CONTINUALLY
IN BETA VERSION, THAT WE'RE
ALWAYS TRYING TO IMPROVE UPON, I
THINK WE AS SCIENTISTS WILL FEEL
BETTER, PARTICULARLY WHEN WE'RE
CONSTANTLY GOING BACK TO OUR
PARTICIPANTS.
IT WILL DEPEND ON THE TOPIC, IT
WILL DEPEND ON THE CONTEXT, IT
WILL DEPEND ON THE STUDY
COMMUNITY THAT WE'RE ENGAGING
WITH.
BUT HERE'S ONE EXAMPLE OF HOW WE
MIGHT THINK ABOUT THIS ITERATIVE
PROCESS FOR RESULTS RETURNED
WHERE WE ENGAGE IN FOCUS GROUPS
OR INTERVIEWS OF PARTICIPANTS TO
GET A SENSE ABOUT WHAT MOTIVATES
THEM TO GET INTO RESEARCH IN THE
FIRST PLACE, WHAT THEY WANT,
THAT CAN INFLUENCE PROTOTYPE
DESIGN, WE CAN CONDUCT USABILITY
TESTING OF PROTOTYPES, THEN WE
ADAPT, THEN WE FINALIZE, THEN WE
TAKE REPORTBACK, WE EVALUATE HOW
IT WENT, WE ADAPT THE PROTOCOL
FOR THE NEXT ROUND, REPEAT.
SO IN TERMS OF FUTURE RESEARCH
AND RECOMMENDATIONS, I THINK
GOING FORWARD, WE WANT TO DO A
GOOD JOB ABOUT HOW DO WE
CHARACTERIZE PARTICIPANTS'
DIVERSE PERSPECTIVES AND THEIR
MOTIVATIONS FOR PARTICIPATING IN
RESEARCH IN THE FIRST PLACE.
WHAT ARE THEIR EXPECTATIONS FOR
RESULTS RETURN?
AND THERE'S LOTS OF WAYS TO DO
THAT.
MANY OF US HAVE DONE IT, WE
DON'T HAVE TO REINVENT THE
WHEEL.
HOW DO WE ASSESS HOW RESULTS
RETURN AFFECTS PARTICIPANTS'
RETENTION AND ENGAGEMENT WITHIN
THE RESEARCH ENTERPRISE?
AGAIN, THERE'S BEEN A LOT OF
LITERATURE PUBLISHED ON THIS.
AND WE CAN RETOOL THE
INSTRUMENTS THAT HAVE BEEN USED
ALREADY FOR EVALUATION FOR OTHER
COULDCONTEXTS.
THENLESS TEST, ADAPT, ENHANCE,
SCALE UP AND EVALUATE
FIELD-TESTS TOTESTED TOOLS WE KK
LIKE DERBI, AND PROVIDE
RESOURCES TO INCENTIVIZE MORE,
LET'S TRY TO DO THAT FOR THE
NEXT ROUND OF REPORTBACK.
THANK YOU.
>>THANKS, RACHEL.
QUESTIONS?
WE HAVE A ZOOM QUESTION?
>>YES.
SO GREAT TALK.
WHEN YOU SAY RESULTS FOR
PARTICIPANTS BELOW 18 WILL BE
RETURNED TO PARENTS, DID YOU
MEAN PARENTS ONLY, OR WILL
CHILDREN ALSO BE INVOLVED?
WILL THEY GET -- WILL THEY NEED
TO GIVE ASCENT?
>>I DIDN'T HEAR THE LAST PART.
>>WILL THEY NEED TO GIVE
ASSENT?
>>THAT'S GOING TO DEPEND ON THE
CONTEXT, THE AGE OF THE CHILD.
THERE HAVE BEEN STUDIES THAT
HAVE CO-REPORTED WITH CHILDREN
AND THEIR PARENTS.
I THINK IT IS VERY
AGE-DEPENDENT.
SO I DON'T THINK THERE'S A ONE
SIZE FITS ALL FOR THAT, BUT I DO
THINK THAT THAT IS AN IMPORTANT
THING TO THINK ABOUT WHEN YOU'RE
LOOKING AT REPORTING BACK
RESULTS BASED ON KIDS AND THEIR
PARENTS OR GUARDIANS, AS THE
CASE MAY BE.
>>ANOTHER QUESTION?
BEN?
>>CAN YOU JUST -- I DON'T THINK
I MISSED THIS.
WHAT ARE THE 13 DATA POINTS THAT
ARE RECOMMENDED TO BE RETURNED?
OR GIVE US SOME EXAMPLES OF
THEM?
>>SOME OF THE EXAMPLES THAT
WERE AGREED UPON AS RECOMMENDED
WERE THINGS LIKE THE PROMIS
GLOBAL HEALTH DATA POINTS,
SLEEP-RELATED QUESTIONS, AND
CHILD PHYSICAL ACTIVITY, CHILD
SLEEP HEALTH, AND THOSE WERE
KIND OF THE BASIC ONES.
ALL THE OTHER ONES, PEOPLE
THOUGHT THAT AT LEAST WITHIN THE
WORK GROUPS THAT IT WOULD NOT BE
VALUABLE TO PARTICIPANTS.
AND AGAIN, I WANT TO EMPHASIZE
THAT I THINK PART OF THE
DECISION-MAKING AND
RECOMMENDATIONS BY THE DIFFERENT
WORK GROUPS WERE DRIVEN BY THE
FACT THAT PEOPLE WERE THINKING
HOW THE HECK DO WE DO THIS
WITHOUT ANY RESOURCES?
AND SO THAT'S -- YOU KNOW, I
THINK PART OF THE PROBLEM WAS
THAT PEOPLE STARTED -- WE
STARTED REALLY BIG, AND WHAT I
WOULD SUGGEST IS THERE'S A LOT
OF REALLY GOOD EXPERIENCE IN
THIS ROOM AND BEYOND WITH
REPORTBACK.
AND SO IF WE'RE REALLY GOING TO
THINK ABOUT HOW TO DO REPORTBACK
IN ECHO, MAYBE WE DON'T HAVE TO
CHEW THE WHOLE PACK OF GUM AT
THE SAME TIME.
WE CAN TAKE LITTLE PIECES THAT
WE KNOW WORK AND BUILD UPON
THOSE.
AND THEN START TO BUILD FROM
THERE.
SO I THINK THAT IN THAT
SITUATION, YOU MIGHT HAVE MORE
RECEPTIVITY, AND PARTICULARLY
WHEN THERE'S TOOLS THAT CAN BE
ADAPTED, PEOPLE AREN'T
REINVENTING THE WHEEL, AND
AGAIN, SOME OF THESE STRATEGIES
WILL BE DISCUSSED TOMORROW.
>>MATT?
>>GREAT TALK, RACHEL.
I WANTED TO GET YOU TO REFLECT A
LITTLE BIT MORE ON WHY THE ECHO
RETURN OF RESULTS POLICY IS ON
THE CONSERVATIVE SIDE.
AND YOU MENTIONED FEASIBILITY.
DO YOU THINK THAT IN YOUR
DELIBERATIONS, YOU HAD THE SORT
OF TWO-DIMENSIONAL GRAPH THAT
JEFF SHOWED WHICH IS SORT OF
VALUE ON ONE AXIS AND
FEASIBILITY ON THE OTHER, SO
THAT'S ONE QUESTION, OR WERE
THEY REALLY SORT OF INTERTWINED
IN A WAY YOU COULDN'T SEPARATE
THEM?
AND THE SECOND IS, HOW MUCH DO
YOU THINK IT'S BECAUSE ECHO HAS
BEEN REALLY A FEDERATION OF
COHORTS WITH DIFFERENT HISTORIES
AND CULTURES?
>>THAT'S A GREAT QUESTION.
I'LL TAKE THE FEDERATION
QUESTION FIRST.
I THINK PART OF IT MAY BE THE
FACT THAT THERE ARE A LOT OF
COHORTS WITHIN ECHO THAT WHEN
THEY BEGAN HADN'T REALLY DONE
THAT BEFORE, AND SO IT JUST
SEEMED LIKE A VERY TALL MOUNTAIN
TO CLIMB, ESPECIALLY IN A
SCENARIO WHERE PUTTING TOGETHER
A FEDERATION OF COHORTS AND
STARTING TO MERGE WHAT WE DO AT
THE SAME TIME, IT JUST SEEMED A
LITTLE OVERWHELMING.
SO -- AND I THINK IN THIS NEXT
PHASE, THERE WILL BE
OPPORTUNITIES, I THINK, TO KIND
OF TRANSCEND THAT CHALLENGE.
AND THE SECOND THING IS, I THINK
IT IS VERY HARD TO DISENTANGLE
THE VALUE AND FEASIBILITY THING
WHEN THERE'S ABSOLUTELY NO
ADDITIONAL RESOURCES TO DO
ANYTHING.
IT'S JUST REALLY HARD.
ESPECIALLY WHEN PEOPLE DON'T
FEEL LIKE THEY HAVE THE
EXPERTISE AND THEY'LL HAVE TO
SEEK IT ELSEWHERE, THEY'RE JUST
LIKE, IT'S NOT VALUABLE TO THE
PARTICIPANT BECAUSE WE CAN'T
MAKE IT VALUABLE.
>>KIND OF ALONG THOSE LINES,
RACHEL, WAS THERE ANY SORT OF
ASSESSMENT OF OR GUEST ESTIMATES
OF WHAT COSTS MIGHT BE FOR A
PARTICULAR ECHO STUDY RETURNING
A LOT OF DIFFERENT ENVIRONMENTAL
DATA OR KIND OF BREAKDOWN OF
WHAT SORTS OF ADDITIONAL
RESOURCES WOULD BE NEEDED, JUST
KIND OF THINKING ABOUT THE
FUTURE OF ECHO GOING FORWARD.
>>I WANT TO STEAL JULIE'S
THUNDER, BUT -- BECAUSE OF THE
OIF AND ALSO DERBI HAS -- SILENT
SPRING HAS REALLY WORKED TO MAKE
DERBI VERY ACCESSIBLE TO OTHER
PARTICIPANTS, AND I WOULD ALSO
ADD NIMBLE THE COSTS AT
LEAST FOR ENVIRONMENTAL HEALTH
DATA AND UTILIZING DERBY ARE
RELATIVELY LOW.
SO JULIE, DO YOU WANT TO SAY
SOMETHING ABOUT THAT?
>>YEAH, RIGHT NOW WE HAVE
CONTEXTUAL INFORMATION FOR ABOUT
150 CHEMICALS, MOSTLY ENDOCRINE
DISRUPTORS AN AND SOME METALS.
RIGHT NOW FOR A NEW STUDY THAT
DOESN'T -- THAT'S USING OUR
PLATFORM, YOU GET YOUR OWN
PRIVATE WORK SPACE FOR $5,000,
AND I'LL SHOW TOMORROW THE
RESEARCHER INTERFACE WHERE YOU
CAN UPLOAD YOUR DATA, YOU CAN
MATCH TO OUR LIBRARY, YOU CAN
CHOOSE OR MODIFY ALL THE CONTENT
SO YOU PICK YOUR OWN PHOTOS, YOU
CAN CHANGE THE TEXT IF YOU THINK
OUR PUERTO RICAN SPANISH IS NOT
WHAT YOU WANT, YOU CAN SWITCH TO
YOUR OWN VERSION.
AND YOU KNOW, WE'RE HAPPY TO
TALK TO ANY TEAMS WHO WANT TO
TRY IT.
AND THERE ARE SOME OTHER TEAMS
WHO ARE TRYING IT RIGHT NOW.
IS THAT HELPFUL?
>>SORRY, DID YOU HAVE A
QUESTION?
JOHNNYE?
>>THAT WAS A GREAT TALK AND
CHALLENGING TO BE THIS LATE
AFTER LUNCH, SO -- BUT I ALSO
WANTED TO KNOW IF YOU SAW
ANYTHING IN SOME OF THE IDEAS
THAT WERE DISCUSSED TODAY THAT
MIGHT ADDRESS SOME OF THAT
FEASIBILITY AND I'M THINKING
SOME OF THE THINGS THAT CAME UP
FROM THE PARTICIPANTS ABOUT
COMBINING OR BUILDING ON OTHER
PEOPLE'S WORK AND THINGS THAT
WERE INDIVIDUAL BUT NOT
NECESSARILY HAVING SOMEBODY GO
OUT TO EVERY DOOR.
BUT NOT NECESSARILY HAVING
SOMEBODY FROM THE TEAM GO TO
EVERY DOOR.
>>YEAH, I MEAN, I THINK THERE'S
SOME --
>>TRANSITION.
>>SO AS PART OF OUR PROJECT
RIGHT NOW WITH THE TWO COHORTS,
ANOTHER PIECE OF IT IS WE HAVE
BEEN TRYING TO DO WORKSHOPS WITH
PARTICIPANTS WHO MIGHT BE
INTERESTED IN UTILIZING DERBY,
AND SO WE KIND OF PUT THAT ON
HIATUS WHILE PEOPLE WERE
FRANTICALLY REAPPLYING FOR ECHO
SO BASICALLY ENABLE PEOPLE TO
SEE HOW IT CAN BE USED WITH
THEIR OWN DATA.
SO I THINK THAT PRESENTS A WAY
TO DO THAT, AT LEAST FOR
ENVIRONMENTAL DATA, AND ADDRESS
SOME OF THE INTERESTING THINGS
THAT OUR PARTICIPANTS TALKED
ABOUT IN THE PANEL BEFORE LUNCH.
I GUESS THE OTHER PARTING THING
I WANT TO LEAVE YOU WITH AS YOU
THINK ABOUT TOMORROW IS I THINK
WE OFTEN FOCUS VERY MUCH ON THIS
TRANSACTIONAL RELATIONSHIP
BETWEEN PARTICIPANTS AND
SCIENTISTS, WHAT'S IN IT FOR THE
PARTICIPANTS, ARE THEY GOING TO
BE ABLE TO DO ANYTHING, ARE THEY
ABLE TO GET ANYTHING OUT IT?
PARTICIPANT ENGAGEMENT AND
REPORTBACK ENCOURAGES YOU TO
LOOK AT YOUR DATA IN WAYS YOU
OTHERWISE MIGHT NOT DO BECAUSE
YOU'RE DOING THOSE INDIVIDUAL
REPORTS, IT HELPS YOU SEE YOU
MIGHT NOT OTHERWISE SEE IN YOUR
DATA.
SO A GREAT EXAMPLE IS, YOU KNOW,
IN THE HOUSEHOLD EXPOSURE STUDY
IN CAPE COD, THERE WERE
PARTICIPANTS THAT HAD HIGH
LEVELS OF PCBs AND WE WERE
SCRATCHING OUR HEADS, WE WERE
TRYING TO FIGURE OUT WHERE IS
THIS STUFF COMING FROM?
IT WAS VERY NOTICEABLE.
WE WENT TO TALK TO THE
PARTICIPANTS.
AND IT LED TO THE DISCOVERY THAT
PCBs ARE EMBEDDED IN FLOOR
POLISH OF WOOD FLOORS, AND SO
WHEN PEOPLE SAND THEIR FLOORS,
PEOPLE GOT EXPOSED.
IT'S IN THE DUST IN THE AIR.
THAT'S SOMETHING THAT WOULD NOT
HAVE BEEN DISCOVERED WITHOUT
THAT MUTUAL EXCHANGE WITH
PARTICIPANTS.
IN FACT, DIALOGUE WITH YOUR
PARTICIPANTS THAT HELPS LEAD TO
DISCOVERIES IN YOUR DATA THAT
YOU MIGHT NOT OTHERWISE HAVE.
SO IT IS GOOD FOR THE SCIENTIFIC
ENTERPRISE, NOT JUST GREAT.
AND SO NOT THINKING OF IT AS A
ZERO SUM GAME RESOURCES FOR
REPORTBACK TAKE AWAY RESOURCES
FROM THE SCIENCE BUT THINKING
ABOUT IT MORE HOLISTICALLY.
GOOD FOR PARTICIPANTS, GOOD FOR
THE SCIENTIFIC ENTERPRISE.
>>THINKING ABOUT THE SIZE OF
ECHO AND THE NUMBER OF PEOPLE
INVOLVED, WAS THERE ANY
DISCUSSION ABOUT A SORT OF
TRANSITIONAL PLAN AT THIS POINT
WHERE THINGS START MAYBE NOT
QUITE WHERE THE PARTICIPANTS
WOULD LIKE TO SEE IT STARTING
BUT START MOVING AND YOU CAN
WORK TOWARDS THE --
>>I'M A BIG FAN OF ITERATIVE
BABY STEP APPROACH, AND STARTING
WITH WHAT YOU KNOW WORKS, AND
THEN BUILDING ON THAT.
SO -- AND I WORRY A LITTLE BIT
ABOUT CENTRALIZATION AND
STANDARDIZATION IN REPORTBACK.
I THINK THAT'S REALLY PORCH WHEN
YOU'RE COLLECTING SAMPLES AND
ADMINISTERING QUESTIONNAIRE, BUT
WITH REPORTBACK, NOT SO MUCHMENT
I THINK YOU NEED SOMETHING --
YOU NEED TOOLS THAT ARE NIMBLE
ENOUGH TO BE ADAPTED TO
DIFFERENT CONTEXTS, COMMUNITIES,
AS HAS BEEN REALLY ELOQUENTLY
DESCRIBED BY OTHERS MUCH MORE SO
THAN ME, AND SO I THINK IF WE
CAN START WITH AN ELEMENT, A
DATA ELEMENT FOR WHICH WE HAD
REALLY GOOD EVIDENCE THAT IT
WORKS AND IT DOESN'T NECESSARILY
HAVE TO BE AN ESSENTIAL DATA
ELEMENT IN ECHO, IT COULD BE ONE
THAT A LOT OF COHORTS ARE
ALREADY DOING FOR WHICH WE
ALREADY HAVE A LOT OF GOOD STUFF
AND I WOULD MAKE A PLUG FOR
ENVIRONMENTAL CHEMICAL
BIOMONITORRING AS A START.
AND THEN FIGURE OUT
STRATEGICALLY FOR THOSE COHORTS
THAT ARE COLLECTING THAT
INFORMATION, HOW DO WE SHARE A
TOOL THAT CAN BE ADAPTED TO THAT
CONTEXT?
AND THEN WE GO FROM THERE.
>>GREAT, THANK YOU, RACHEL.
SO NOW WE'LL TRANSITION TO OUR
DISCUSSANT, CARMEN.
>>GREETINGS TO ALL WHO ARE
HERE.
SHARING THIS KNOWLEDGE AND
EXPERIENCE ON THIS IMPORTANT
ASPECT OF RESEARCH SUCH AS
RETURNING RESULTS TO
PARTICIPANTS AS A RESPONSE TO
THE RIGHT TO KNOW.
GREETINGS TO ALL THAT ARE
CONNECTED TO THIS MEETING AND
THANK YOU FOR YOUR INTEREST.
WE HAVE JUST HAD THE PRIVILEGE
OF LISTENING TO FOUR VERY
RELEVANT AND IMPORTANT
PRESENTATIONS THAT ARE INTENDED
NOT TO QUESTION TO RETURN OR NOT
TO RETURN, BUT RATHER WHICH TYPE
OF RESEARCH RESULTS SHOULD BE
RETURNED AND WHY.
I UNDERSTAND THERE ARE SEVERAL
VERY IMPORTANT POINTS THAT HAVE
BEEN MADE IN THESE PRESENTATIONS
THAT REQUIRE FURTHER DIALOGUE
AND ESPECIALLY WORK TO ACTION.
FIRST IT IS NOT A MATTER OF
RETURNING OR NOT RETURNING.
OR IF IT CAN BE HELPFUL TO BOTH
THE PARTICIPANT AND THE RESEARCH
TEAM.
BUT RATHER WHICH ARE THE BEST
TYPES OF RESULTS TO RETURN THAT
RUND STANDABLE, USEFUL, AND
ACTIONABLE TO PARTICIPANTS
WITHOUT ADDING UNNECESSARY
STRESS OR BURDEN.
IN DR. BERKMAN'S PRESENTATION WE
HEARD NOT ALL RESEARCH STUDIES
HAVE TO RETURN RESEARCH
FINDINGS.
HERE THE DEPTH OF THE
RELATIONSHIP BETWEEN THE
RESEARCHER AND PARTICIPANTS IS
KEY.
IN HIS PRESENTATION, HE TALKS
ABOUT THE DIFFERENT VALUES THAT
ARE DIRECT OR INDIRECT AS
CONSIDERATION FOR REPORTBACK AND
THIS IS VERY IMPORTANT.
IN OUR EXPERIENCE IN OUR PROTECT
ECHO COHORT, PARTICIPANTS WANT
TO KNOW.
THEY WANT TO KNOW IF SOMETHING
IS NOT QUITE RIGHT, AND WHAT TO
DO, AS WELL AS WHEN RESULTS ARE
POSITIVE.
AS FOR EXAMPLE, IF MY CHILD IS
DEVELOPING WITHIN THE EXPECTED
PARAMETERS.
PEOPLE LIKE TO LISTEN TO GOOD
NEWS TOO.
IN THIS SENSE, THE VALUE OF
THE -- FOR THE PARTICIPANT CAN
BE FOR BOTH TYPES OF RESULTS.
WE HAVE HEARD RESULTS RETURNED
TO PARTICIPANTS WHO HAVE A CLEAR
AND ONGOING RELEVANCE TO HEALTH.
THIS IN MY OPINION IS VERY
IMPORTANT, IS A VERY IMPORTANT
POINT, BUT I BELIEVE THE
REPORTING BACK RESULTS THAT ARE
BEING INVESTIGATED AND HAVE
RESULTS THAT POINT TO POSSIBLE
BUT UNCERTAIN EEIVETLE ON HEALTH
ARE VALUABLE AS WELL.
PARTICIPANTS UNDERSTAND WHEN WE
EXPLAIN THERE IS NOT ENOUGH
RESEARCH TO SAY CATEGORICALLY
THE EFFECT -- OR THE EXACT
EFFECTS ON HEALTH, YET SEE THE
VALUE OF ALERTING THEM TO THE
POSSIBILITY.
I DO BELIEVE WE SOMETIMES
UNDERESTIMATE THE CAPACITY OF
PARTICIPANTS TO UNDERSTAND THESE
RESULTS, AND ESPECIALLY WHEN
THERE ARE UNCERTAIN EFFECTS.
AS JOHNNYE LEWIS SAID EARLIER,
PEOPLE DEAL WITH UNCERTAINTY BY
BEING VIGILANT.
THIS IS APPRECIATED BY THEM.
ANOTHER POINT IS THAT REPORTBACK
NEEDS TO BE ACCOMPANIED WITH
INFORMATION ON HOW TO UNDERSTAND
RESULTS, AND WHAT TO DO TO
REDUCE EXPOSURES OR TO MAKE
BEHAVIORAL CHANGE TO SUPPORT
HEALTH DEVELOPMENT -- HEALTHY
DEVELOPMENT.
THE CONTEXT OF THESE RESULTS IS
VITAL TO EFFECTIVE AND USEFUL
REPORTBACK.
IT IS ALSO OF GREAT IMPORTANCE
TO INVESTIGATE THE IMPACT OF
REPORT BACK ON THE PARTICIPANTS.
AND WHAT ARE THEIR EXPECTATIONS,
PREFERENCES AND INTERESTS IN
TERMS OF HOW, WHAT, WHEN, AND
WHO SHOULD PROVIDE THE
REPORTBACK.
IN OUR EXPERIENCE WITH OUR
PROTECT ECHO COHORT, WE BEGAN
WITH OUR COMMUNITY ENGAGEMENT
AND WE WERE LUCKY ENOUGH BECAUSE
OUR ORIGINAL COHORT IS THE SUPER
FUND RESEARCH PROGRAM AND THESE
PROGRAMS HAVE ENGAGEMENT CORE
AND RESEARCH TRANSLATION CORE,
SO THAT GAVE US A LOT OF THE
INFRASTRUCTURE THAT RACHEL WAS
TALKING ABOUT.
WE ALREADY HAD THE BASIS.
AND THAT'S REALLY IMPORTANT
BECAUSE IT'S EASY FOR ME TO
STAND HERE AND SAY OH, YOU
SHOULD DO THIS, BUT WITHOUT
HAVING THE ADVANTAGES THAT WE
HAVE WITH OUR COHORT.
SO I THINK THAT IS IMPORTANT TO
SAY.
SO WE DID THIS STUDY VERY EARLY
ON AND WE WERE ABLE TO FIGURE
OUT WAYS TO DO THIS.
WE ALSO TALKED ABOUT THE FORMATS
OF SUCH REPORTBACK.
AND WITH THE HELP OF SILENT
SPRING INSTITUTE, WE IMPLEMENTED
THE FIRST REPORTBACK APP ON A
MOBILE PHONE.
AND A MOBILE PHONE BECAUSE OUR
PARTICIPANT SAID WE DON'T HAVE
COMPUTER, WE NEED OUR RESULTS TO
BE AVAILABLE ON THE PHONE.
AND THIS WAS PART OF THE -- OF
THIS RELATIONSHIP.
THIS PROCESS IS CONTINUOUS, AND
WITH THE HELP OF OUR COMMUNITY
ADVISORY TEAM WHERE PARTICIPANTS
ARE REPRESENTED AS WELL AS
COMMUNITY COLLABORATORS, WE HAVE
BEEN ABLE TO CREATE A TOOL THAT
IS RESPONSIVE AND CULTURALLY
COMPETENT.
TO OUR PARTICIPANTS, IT'S ALWAYS
BEEN IMPORTANT TO RECEIVE THE
RESULTS AND TO HAVE A SAY ON HOW
THIS IS DONE.
THEY HAVE TOLD US EXPLICITLY NOT
ONLY THAT THEY WANT TO KNOW, BUT
HOW THEY WANT THIS INFORMATION
DELIVERED AND COMBINED WITH
SUGGESTIONS AS TO HOW TO CREATE
ACTION.
REPORTBACK IS A PROCESS, AND IN
MY OPINION CAN BENEFIT WITH
BEGINNING TO PROVIDE INFORMATION
TO PARTICIPANTS IN THE BEGINNING
OF THEIR PARTICIPATION.
ON WHAT THE SCIENTIFIC
LITERATURE IS SAYING, WHAT IS
THE EVIDENCE IN TERMS OF WHAT IS
BEING STUDIED, AS WELL AS
OFFERING INFORMATION ON
AGGREGATE RESULTS FROM PREVIOUS,
FROM RESULTS THAT ARE PREVIOUS
TO THE PARTICIPANTS ENTERING THE
PROGRAM.
IN ORDER TO INFORM ON WHAT IS
BEING STUDIED.
WHAT WE KNOW, AND WHAT CAN HELP
THEM EVEN BEFORE WE GIVE THEM
INDIVIDUAL REPORTBACK.
THAT, TO US, IS IMPORTANT.
WE CAN'T JUST SIT THERE AND NOT
SAY ANYTHING WHEN WE KNOW THERE
ARE THINGS -- WE ALREADY KNOW
THINGS.
SO IF WE KNOW THESE THINGS, THIS
IS SOMETHING THAT WE SHOULD BE
SHARING WITH OUR PARTICIPANTS AS
BEST WE CAN.
WE HAVE HEARD ABOUT THE EFFORT
THAT HAS BEEN IN PROGRESS WITH
THE ECHO RETURN OF RESULTS
WORKING GROUP, AND I APPLAUD
THIS INITIATIVE, AND BELIEVE
THIS WORK COULD BE HELPED
PERHAPS WITH THE REPRESENTATION
OF FIELD STAFF AND PARTICIPANTS
AS WELL AS COMMUNITY PARTNERS
INCLUDING PARTICIPANTS.
AND I KNOW THIS IS PART OF THE
FINDINGS OF THIS WORK GROUP.
THE FINDINGS AND RECOMMENDATIONS
OF THIS WORK GROUP SEEM TO ME
THE FOUNDATION OF A POLICY FOR
REPORTBACK FOR ECHO.
I ALSO HEARD AND AGREE WITH THE
RESULTS WITH RETURN OF RESULTS
WORK GROUP THAT RESEARCH
PROGRAMS NEED RESOURCES TO
DEVELOP INFRASTRUCTURE AND
CAPACITY TO OFFER REPORTBACK AND
FOLLOW-UP.
IN ORDER TO PROVIDE ADEQUATE
ATTENTION TO REPORTBACK, WE NEED
TO MAKE THIS AN INTEGRAL PART OF
THE PROGRAM WITH A SET OF POLICY
AND PRACTICES AS WELL AS A
DEDICATED TIME AND EFFORT OF
STAFF TO DO SO.
A VERY IMPORTANT FINDING AND
RECOMMENDATION POINTS TO THE
NEED TO BUILD CAPACITY FOR
RESEARCHERS AND RESEARCH STAFF
TO BE ABLE TO ENGAGE
PARTICIPANTS WITH REPORTBACK,
WHERE THE PROGRAM STAFF HAVE
RESOURCES TO REFER TO
APPROPRIATE FOLLOW-UP ON
FINDINGS.
AS YOU CANNOT JUST GO THERE AND
GIVE THEM BAD NEWS IF YOU DON'T
HAVE ALTERNATIVES TO THEM, TELL
THEM YOUR CHILD IS DELAYED IF
YOU DON'T HAVE INFORMATION IN
TERMS OF WHAT THEY CAN DO TO
IMPROVE OR WHERE THEY CAN GO TO
GET HELP.
THERE IS AN AMAZING POTENTIAL TO
DO SIGNIFICANT RELEVANT WORK TO
DEMONSTRATE THE IMPORTANCE AND
VALUE OF REPORTBACK IN ECHO.
I THINK THIS IS JUST THE
BEGINNING AND WE HAVE A WAY TO
GO.
FOR THIS WORK -- FOR THIS, WE
MUST WORK ON.
SO THANK YOU VERY MUCH.
>>THANK YOU, CARMEN.
IF WE COULD HAVE THE SESSION
3 SPEAKERS JOIN US UP HERE AT
THE PANEL TABLE.
CARMEN?
YOU CAN STAY UP HERE WITH THE
SPEAKERS.
ALL RIGHT.
WE WILL NOW OPEN IT UP FOR OPEN
DISCUSSION.
MATT?
>>LET ME OPEN THIS UP WITH I'M
A FORMER PRIMARY CARE DOC.
BUT WHY ALL THIS TALK ABOUT
CLINICAL UTILITY AND GETTING
CLINICIANS INVOLVED, WHEN WE'RE
TALKING ABOUT PUBLIC HEALTH
INFORMATION?
AND WHAT ABOUT THIS IDEA OF THE
ENVIRONMENTAL COUNSELOR AS THE
ANALOGY TO THE GENETIC
COUNSELOR?
SO ARE WE BARKING UP THE WRONG
TREE WHEN WE'RE TRYING TO HAVE
THE CLINICIAN BE THE TRANS A
LITRANSLATORCOMMUNICATOR AND SHE
THINKING ABOUT SO SOME OTHER AVE
FOR EPIDEMIOLOGIC STUDIES THAT
ARE IN GENERAL POPULATIONS WHERE
THE THINGS THAT WE DISCOVER ARE
NOT REALLY MEDICAL.
SOME OF THEM MIGHT BE MEDICAL
BUT MOST OF THEM AREN'T.
AND THIS IS A QUESTION THAT WE
MIGHT ASK TOMORROW TOO, BUT
BEGIN THE DISCUSSION HERE.
>>WELL, I THINK PART OF WHY WE
KEEP SAYING CLINICAL UTILITY IS
THAT A LOT OF THIS DEBATE HAS
COME OUT OF THE GENETIC RETURN
OF RESULTS LITERATURE WHERE THAT
HAS BEEN ONE OF THE KEY ISSUES
AND DEFINITIONS AND WAYS TO
DISTINGUISH THE KINDS OF THINGS
WE SHOULD AND SHOULDN'T RETURN.
SO PART OF IT IS JUST A VESTIGE
OF THE EARLIER VERSIONS OF THIS
DEBATE BUT AS NEW METHODOLOGIES,
NEW KINDS OF RESEARCH TAKE ON
THIS RETURN OF RESULTS QUESTION,
YOU'RE RIGHT THAT THEY HAVE TO
REINVENT THE QUESTIONS IN THE
DEBATE, YOU CAN'T JUST PORT OVER
THE ORIGINAL WAYS OF THINKING.
BUT I DO THINK THERE'S SOME
UTILITY, AND SO AT LEAST FROM
MY -- I CAN'T SPEAK FOR EVERYONE
ELSE, BUT WHEN I SAY CLINICAL
UTILITY, I REALLY MEAN VALUE.
I REALLY MEAN WOULD BE USEFUL IN
SOME WAY TO THE PARTICIPANT.
SO SOMETIMES THAT'S GOING TO BE
CLINICAL VALUE, SOMETIMES THAT'S
GOING TO BE MORE OF A PREVENTIVE
VALUE, SOMETIMES IT WILL BE
ENVIRONMENTAL, A WAY TO AVOID
CERTAIN KINDS OF EXPOSURES.
THERE ARE LOTS OF WAYS -- I LUMP
THAT MAYBE WE NEED TO HAVE
DIFFERENT LANGUAGE AND BE MORE
PRECISE, BUT I LUMP ALL OF THAT
UNDER CLINICAL UTILITY IN THE
SENSE THAT IT CAN ALL POSITIVELY
IMPACT THE HEALTH OF THE
PARTICIPANTS, AND SO THAT'S THE
WAY I WAS USING THE TERM AND
JUST TO SPELL IT OUT A LITTLE
FURTHER, WHEN WE'RE TRYING TO
FIGURE OUT WHAT TO RETURN AND
WHAT NOT TO RETURN, THE MORE
DIRECT HELPFUL VALUE IT CAN
PROVIDE TO PARTICIPANTS, THE
STRONGER REASON THERE IS TO
RETURN IT.
>>ANYBODY ELSE WANT TO TACKLE
THAT?
I MEANT TO BE KIND OF
CONTROVERSIAL.
>>I MEAN, I THINK -- I MEAN, I
THINK IT'S A -- I THINK IT'S A
PROVOCATIVE IDEA.
I WONDER ABOUT, YOU KNOW, WHEN
WE'RE -- AND MAYBE WE COULD
CENTER IT AROUND AN EXAMPLE, BUT
I THINK THAT THE SYSTEM THROUGH
WHICH THE PARTICIPANT OR THE
INDIVIDUAL ACCESSES CHANGE OR
CONSIDERS HOW THEY MIGHT ALTER
WHATEVER THE ANTECEDENT IS
THAT'S CAUSING TO HAVE USE IS
FREQUENTLY THOUGHT OF IN MEDICAL
TERMINOLOGY.
SO I THINK IT EVEN REQUIRES JUST
A, PERHAPS, CREATION, AND I
THINK THIS IS MAYBE WHAT YOU'RE
PROPOSING, OF AN ENTIRELY NEW
FRAMEWORK, A DIFFERENT SYSTEM,
BECAUSE WE'RE SO USED TO
THINKING ABOUT CLINICAL AND
HEALTH OUTCOMES AS BEING IN THE
DOMAIN OF THE HEALTHCARE AND THE
MEDICAL SYSTEM.
>>NOTICE WE CALL IT HEALTHCARE
WHEN IT'S ACTUALLY MEDICAL CARE.
AND HEALTH IS -- MUCH OF HEALTH
IS OUTSIDE OF MEDICINE.
AND AGAIN, I CAN SAY THIS
BECAUSE I'M A DOC.
>>I MEAN, I THINK -- I COULDN'T
AGREE WITH WHAT YOU JUST SAID
MORE.
I MEAN, I THINK THAT AT LEAST IN
THE ENVIRONMENTAL HEALTH REALM,
MOST OF THE RESULTS WE RETURN
ARE NOT CLINICALLY RELEVANT.
WE DON'T KNOW WHAT THEIR
CLINICAL RELEVANCE IS, UNLESS
YOU'RE DEALING WITH SOMETHING
LIKE LEARD MA LEAD MAYBE OR THIR
WHICH WE HAVE A LOT OF EVIDENCE,
WE HAVE THINGS THAT WE COULD DO.
AND I THINK IF WE THINK MORE AS
PUBLIC HEALTH RESEARCHERS, THEN
I THINK THAT FREES UP OUR
IMAGINATION ABOUT THE ETHICS OF
REPORTBACK AND WHAT IS ETHICAL
TO PROVIDE TO PARTICIPANTS, AND
THE FACT THAT WHEN WE THINK
ABOUT POPULATION HEALTH, WE'RE
ALSO WILLING TO ACCEPT THE FACT
AND CONVEY TO PARTICIPANTS THAT
THERE ARE CERTAIN KINDS OF
EXPOSURES THAT THEY CAN'T DO
ANYTHING ABOUT AS INDIVIDUALS.
BULL -- AND THAT'S AN IMPORTANT
PUBLIC HEALTH ISSUE.
THAT'S WHAT PICK HEALTH IS ALL
ABOUT.
IT'S ABOUT STRUCTURAL CHANGE,
IT'S ABOUT ELEVATING
ENVIRONMENTAL HEALTH LITERACY SO
THAT PEOPLE COULD UNDERSTAND HOW
EXPOSURE REDUCTION CAN'T ALWAYS
JUST BE YOUR PERSONAL RISK
ASSESSMENT EVERY TIME YOU GO TO
THE GROCERY STORE OR THE
DRUGSTORE.
THAT IT IS ABOUT SOCIAL
DECISIONS AND THAT'S THAT'S
VALUABLE, AND THINK AN IMPORTANT
ETHICAL THING THAT WE NEED TO
CONSIDER WHEN WE DO REPORTBACK,
OPPORTUNITIES FOR INDIVIDUAL AND
COLLECTIVE ACTION.
>>AND I THINK IN YOUR -- YOU
HAVE A NICE GRAPHIC, RACHEL,
WHERE YOU'RE TALKING ABOUT
COMMUNITY ACTION FOR SOME KINDS
OF ENVIRONMENTAL INFLUENCES AND
INDIVIDUAL ACTION FOR OTHERS.
AND EVEN THE INDIVIDUAL ACTION
WAS NOT NECESSARILY MEDIATED
THROUGH A MEDICAL SYSTEM, RIGHT?
SO IT CAN BE INDIVIDUAL ACTION,
COMMUNITY ACTION.
SO, YOU KNOW, THE WAY I THINK
ABOUT IT IS, OKAY, BLOOD
PRESSURE, YEAH, WE HAVE SOME
CLINICAL NORMS IN BLOOD
PRESSURE, WE KNOW WHAT TO DO.
BMI, OKAY, WELL, WE HAVE SOME
CLINICAL RECOMMENDATIONS FOR
BMI.
WE'RE NOT THAT GREAT AT IT.
DEPRESSION AND ANXIETY, OKAY,
MAYBE.
BUT THEN WE GET TO SOME OF THE
THINGS THAT YOU'RE TALKING
ABOUT, WHETHER THEY BE TOXIC
ENVIRONMENT OR OTHER SCALES THAT
WE MEASURE, SO I JUST --
ENCOURAGING US ALL TO THINK
ABOUT WHERE IS THE EFFECTOR ARM.
AND YOU'RE ALL POINTING OUT THAT
THERE NEEDS TO BE A REAL
CONSIDERATION OF FEASIBILITY AND
PART OF THAT FEASIBILITY IS THE
EFFECTOR.
>>JOHNNYE?
>>I GUESS I WOULD REALLY LIKE
TO SEE THE WHOLE DISCUSSION
FRAMED MUCH MOR MORE HOE L HOLI.
IF WE LOOK AT THE LARGEST GAPS
OF MEDICAL TRAINING IN THE
COUNTRY, FOR PROBABLY THE LAST
70 YEARS, THE MAIN GAP HAS BEEN
THERE IS NEVER ANYTHING INCLUDED
IN MEDICAL CURRICULA ON
ENVIRONMENTAL OR OCCUPATIONAL
EXPOSURES.
AND YET THOSE ACCOUNT FOR A LOT
OF AT LEAST COFACTORS OR
INTERACTIVE EFFECTS.
OR SENSITIVITY TO A LOT OF THE
OUTCOMES WE'RE TALKING ABOUT IN
THE GENOMICS ANALYSIS.
AND WE KEEP SEPARATING THOSE AND
WE KEEP -- I MEAN, THERE ARE
PEOPLE IN THIS ROOM WHO HAVE
BEEN PUBLISHING RETURN OF
RESULTS FOR ALMOST 30 YEARS AND
YET ALL WE'RE HEARING IS THAT
THE FIELD STARTED WITH GENOMICS.
I DON'T THINK THAT DOES ANYBODY
ANY BENEFIT.
I MEAN, I THINK WE HAVE TO LOOK
AT THIS MUCH MORE HOLISTICALLY
THAT THESE ARE INTERACTIONS AND
WHEN WE SAY THAT ENVIRONMENTAL
RESULTS ARE NOT ACTIONABLE, I
THINK THAT'S REALLY SELLING IT
SHORT.
IF WE'RE LOOKING AT -- EVEN WITH
CANCER, THE LIKELIHOOD THAT THIS
IS NOT A PURELY GENETIC
PHENOMENON BUT IT IS AN
INTERACTION.
SO YOU HAVE TO SEE BROTH SIDES
SEE BOTH SIDES OFTHAT EQUATION.
IT SEEMS TO ME TO REALLY MAKE
PROGRESS AND FLF PARTICIPANTS
ABOUT RISK IN A REALISTIC MANNER
THAT'S GOING TO BE UNDERSTOOD,
SO I'D BE WILLING TO BET THAT
OUR PARTICIPANTS HAVE A MUCH
MORE REALISTIC VIEW OF HEALTH
THAN A LOT OF THE RESEARCHERS
DO.
SO JUST THROWING THAT OUT THERE.
>>WE CAN TAKE THE EXAMPLE OF
SMOKING, RIGHT?
I MEAN, PEOPLE WHO SMOKE,
DOCTORS TELL THEM TO STOP
SMOKING, BUT WE KNOW THAT
SMOKING RATES DIDN'T GO DOWN
BECAUSE GAZILLIONS OF DOCTORS
WERE TELLING THEIR PATIENTS TO
STOP SMOKING, RIGHT?
SMOKING RATES WENT DOWN BECAUSE
OF STRUCTURAL COLLECTIVE POLICY
CHANGE AND ALL THESE THINGS THAT
WE DID TO SHIFT -- MAKE IT EASY
FOR PEOPLE TO CHANGE THEIR
BEHAVIORS.
>>I ALSO THINK THAT THE ACTION,
YOU KNOW, THE WHOLE PROCESS OF
REPORTBACK BUILDS ON THE TRUST
THAT PEOPLE HAVE IN RESEARCH.
I COME FROM A PLACE WHERE MANY
COMMUNITIES DO NOT TRUST
RESEARCHERS.
WE HAVE HAD RESEARCH COME IN AND
TEST AGENT ORANGE WITHOUT
TELLING US.
WE HAD MOST OF OUR WOMEN
STERILIZED AT ONE POINT IN TIME
WITHOUT THEM KNOWING, AND
WITHOUT HAVING INFORMED CONSENT.
SO THERE ARE SO MANY COMMUNITIES
IN OUR SPACES THAT HAVE NO TRUST
AND FOR GOOD REASON IN RESEARCH.
SO THIS IS AN OPPORTUNITY TO
BUILD ON THAT.
AND NOT ONLY BUILD ON THAT BUT
ALSO BUILD CAPACITY, AND I
WANTED TO TALK TO THAT BECAUSE
WE NEED TO BUILD CAPACITY TO BE
ABLE TO DO THIS BUT ALSO DOING
IT, WE BUILD CAPACITY.
ONE THING WE DO WITH NURSES IN
OUR PROJECT, IN OUR PROGRAM IS
THAT THEY ARE BEGINNING TO DO
REPORTBACK, AND THAT HAS DONE A
TREMENDOUS -- HAS HAD A
TREMENDOUS EFFECT NOT JUST ON
THE PARTICIPANT BUT ON OUR
STAFF, BECAUSE THEY FEEL MORE
EMPOWERED, THEY FEEL THAT
THEY'RE NOT JUST THERE TO ASK
ALL THESE GAZILLION QUESTIONS
AND TAKE ALL THESE SAMPLES FROM
PEOPLE, BUT THAT THEY KNOW
WHAT'S BEHIND THIS AND THEY CAN
TELL THEM THIS IS WHAT WE'RE
LOOKING AT.
AND WE MIGHT NOT KNOW RIGHT NOW,
BUT MAYBE SOMEDAY WE WILL.
AND THAT IN ITSELF AND THE
DEVELOPMENT OF MATERIALS TO
REDUCE EXPOSURES, TO PROMOTE
DEVELOPMENT, PUT US INTO A
HEALTH PROMOTION MODE AND I
THINK THAT THAT IS ONE OF THE
BIG VANGS OF THIS.
>>THIS HAS BEEN A GREAT
MORNING.
IN THE CONTEXT OF A CONTROLLED
CLINICAL TRIAL, DOUBLE BLIND
CLINICAL TRIAL, IN THE MIDDLE OF
THE TRIAL YOU FIND AN INDIVIDUAL
REPORT HAS TO BE CONVEYED TO A
PARTICIPANT, AND IF THAT
PARTICIPANT WANTS TO KNOW WHAT
HE OR SHE RECEIVED, WHICH GROUP
THAT HE OR SHE BELONGED TO, WHAT
ARE THE PARTICULAR APPLICATIONS
OF SUBJECTS TO REVIEW THAT TO
THE PARTICIPANT, AND WHAT ARE
THE RESEARCH RISKS OF DOING
THAT, BECAUSE IT'S SUPPOSED TO
BE UNTIL THE STUDY IS DONE, THE
BLINDING HAS TO BE MAINTAINED,
SO THERE'S THAT CONCERN THAT YOU
WOULD HAVE TO HANDLE THAT.
SO I WANTED TO KNOW WHAT ARE
YOUR THOUGHTS.
THANK YOU.
>>I MEAN, I THINK IT WOULD BE
VERY CONTEXT-DEPENDENT BUT THE
GENERAL RULE, AT LEAST TO MY
MIND, WOULD BE IF KNOWLEDGE
ABOUT WHETHER OR NOT THEY WERE
IN THE ACTIVE OR PLACEBO ARM WAS
DIRECTLY RELEVANT TO WHATEVER
HEALTH INFORMATION HAD BEEN
REVEALED OR SITUATION, THEN THEY
SHOULD CERTAINLY -- IF IT WAS A
QUESTION OF PATIENT SAFETY, YOU
ALWAYS BREAK THE BLIND.
BUT IF IT WAS JUST SOMETHING
THAT THEY WANTED TO KNOW, UNLESS
THERE WAS A STRONG CLINICAL
REASON, YOU GENERALLY DON'T
BREAK THE -- THEY ALWAYS HAVE
THE RIGHT TO WITHDRAW, AND
WITHDRAWING MAYBE INFORMATION
COULD BE REVEALED TO THEM, BUT
YOU KEEP ASKING ABOUT INTEGRITY
OF THE RESEARCH.
YOU CAN'T -- IF THERE'S AN
IMPORTANT REASON TO MAINTAIN A
BLIND, YOU CAN'T JUST BREAK IT
BECAUSE PEOPLE WANT IT, IF
THAT'S HOW THE STUDY IS
DESIGNED.
>>JEFF?
>>SO I WANTED TO FOLLOW UP ON
CARMEN'S IDEA ABOUT BUILDING
CAPACITY IN STAFF AND MAKING
THEM FEEL THEY'RE PART OF
SOMETHING BIGGER THAN JUST
COLLECTING DATA.
BECAUSE ONE OF THE CONCERNS WITH
RESOURCES IS THE -- RETURNING
CERTAIN TYPES OF RESULTS, YOU
NEED INDIVIDUAL SPECIAL SKILLS
TO BE ABLE TO DO THAT.
SO LIKE GENETIC COUNSELORS OR,
YOU KNOW, REPORTING BACK ON
MENTAL HEALTH OR, LIKE, CHILD
DEVELOPMENT CONDITIONS, BECAUSE
YOU WANT THEM TO BE ABLE TO
RESPOND TO QUESTIONS WHEN THERE
ARE FROM PARTICIPANTS.
IS THIS SOMETHING WE SHOULD BE
THINKING ABOUT, IS THIS
SOMETHING THAT CAN BE TRAINED,
CAN RESEARCH PERSONNEL BE
TRAINED IN A WAY TO DO SOME OF
THIS, TO ALLEVIATE SOME OF THE
RESOURCE NEEDS THAT WE'VE BEEN
TALKING ABOUT?
IS THAT SOMETHING THAT SHOULD BE
CONSIDERED?
>>I MEAN, I CAN TAKE A STAB AT
THAT.
IT'S AN AREA OF DEBATE IN THE
GENOMICS WORLD FOR SURE BECAUSE
THERE'S A HUGE SHORTAGE AND
THERE'S PROJECTED TO BE A
SHORTAGE OF GENOMICS
PROFESSIONALS FOR THE NEXT
COUPLE DECADES.
SO I THINK THAT YOU CAN'T -- I
THINK YOU CAN SIT IN A PLACE
WHERE YOU'RE WORRIED ABOUT
HAVING CAPACITY FOR A VERY, VERY
LONG TIME, OR YOU CAN TRY
DIFFERENT STRATEGIES TO RETURN
FINDINGS TO PEOPLE AND SEE HOW
THEY WORK, AND THE STUDIES I
SIGHTED WAS A RANDOMIZED STUDY
THAT A SET OF GENOMIC RESULTS
WERE RETURNED TO PEOPLE THROUGH
A WEB INTERFACE OR A GENETIC
COUNSELOR AND THOSE WERE NOT
INFERIOR.
SO THIS WAS EQUALLY -- THESE
WERE EQUALLY APPROPRIATE WAYS OF
RETURNING SOME OF THOSE RESULTS.
AND I THINK THAT'S THE KIND OF
DATA THAT ARE NEEDED PRECISELY
TO ANSWER THAT QUESTION.
SO YOU CAN HYPOTHESIZE THAT
COULD BE A WAY.
FROM MY PERSPECTIVE, TO MAKE
SURE YOU'RE EVALUATING OR
TESTING THAT HYPOTHESIS, AND
SEEING WHERE OR WHAT TYPES OF
PERSONNEL NEEDED IN ORDER TO
HAVE WHICH TYPES OF
COMMUNICATIONS WITH RESEARCH
PARTICIPANTS AND PATIENTS ALSO.
>>WHAT WE HAVE DONE, BECAUSE
AGAIN, I DON'T THINK THAT YOU
CAN IMPOSE ON PEOPLE THAT IS NOT
THEIR PREPARATION TO DO THIS,
BUT YOU CAN KNOW ENOUGH TO GIVE
THE BASIC INFORMATION AND HAVE
ON CALL PEOPLE THAT WILL ANSWER
THE DEEP QUESTIONS.
AND DO THE REFERRALS.
WE DON'T HAVE ENOUGH RESOURCES
TO HAVE A PEDIATRICIAN SITTING
THERE ALL DAY OR HAVE A
SPECIALIST, BUT WE DO HAVE
PEOPLE THAT ARE ON CALL.
AND AT ONE TIME WE EVEN HAD A
CHILD NEUROLOGIST JUST BECAUSE
IN PUERTO RICO THERE WERE HARDLY
ANY, AND BY THE TIME A PARENT
WOULD GET A CONSULT, IT WOULD BE
SIX MONTH DOWN THE ROAD.
AND THAT, YOU KNOW, IT'S NOT
OPTIMAL.
SO THAT'S SORT OF A WAY THAT WE
HAVE DONE THIS.
WE ARE BASED IN A SCHOOL OF
HEALTH SCIENCES WHERE THERE IS
PUBLIC HEALTH, THERE IS
MEDICINE, THERE IS PHARMACY, AND
WHETHER WE MAKE USE OF THOSE
RESOURCES, TO DO THIS, A
CLINICAL PSYCHOLOGIST, NOT
SITTING THERE, YOU KNOW, NOT ON
A FULL-TIME BASIS BUT ON A
CONSULTANT BASIS BECAUSE IT'S
NOT EVERYONE THAT'S GOING TO
NEED THIS.
PEOPLE THAT HAVE THESE RESULTS
THAT ARE OUT OF THE NORM.
I'M JUST TALKING ABOUT OUR
EXPERIENCE, A WAY WE'VE BEEN
ABLE TO PROVIDE THIS WITHOUT
HAVING ALL THE RESOURCES THAT IT
WOULD TAKE.
>>I JUST WANT TO MAKE A PLUG
FOR WHAT JULIE WAS TALKING ABOUT
AT THE INFO SESSIONS.
THOSE CAN WORK REALLY NICELY,
BECAUSE VERY OFTEN IT'S NICE FOR
PARTICIPANTS, PARTICIPANTS
ACTUALLY WANT TO LEARN ABOUT
EACH OTHER AND COME TOGETHER FOR
THOSE PARTICIPANTS THAT ARE
MOTIVATED TO DO THAT.
THAT'S AN INCREDIBLE
OPPORTUNITY.
YOU CAN TALK ABOUT THE AGGREGATE
RESULTS SO ONE THING THAT WE DID
AND WORKED WITH THE STUDY TO DO
IS THEY HAVE REGULAR COMMUNITY
MEETINGS WITH THEIR PARTICIPANTS
AND SO IN THIS ONE, THE
COMMUNITY MEETING WAS TO
REPORTING A GAT RESULTS AND
ANSWER QUESTIONS ABOUT AGGREGATE
RESULTS AND THEN MANY OF US MADE
OURSELVES AVAILABLE AFTER THE
LARGE SESSION TO HAVE INDIVIDUAL
CONSULTATION WITH PARTICIPANTS
ABOUT THEIR INDIVIDUAL RESULTS
RIGHT THERE ON THE SPOT.
SO PEOPLE CAME, THERE WAS FOOD,
THERE WAS CHILD CARE, AND WE
WERE ABLE TO JUST KIND OF DO IT
IN A LARGE GROUP AND IT WORKED
QUITE WELL.
GLL JEFF, DID YO
>>JEFF, DID YOU HAVE A QUESTION
EARLIER?
>>I THINK FOLKS HAVE TOUCHED ON
IT BUT ONE WAS FOR CARMEN, YOU
USED THE TERM REPORTBACK PRETTY
CONSISTENTLY AS OPPOSED TO
RETURN OF RESULTS.
I WONDER IF THERE'S A DIFFERENCE
THERE.
IS REPORTBACK -- DOES THAT
INCLUDE A BROADER SET OF REPORTS
THAN INDIVIDUAL RESULTS?
>>NOT REALLY.
THAT'S THE WAY I WAS TAUGHT BY
DR. PHIL BROWN AND JULIE BRODY.
I WAS TAUGHT TO CALL IT THAT
WAY, AND I CALLED IT THAT WAY
EVER SINCE.
AND PEOPLE KIND OF RELATE TO IT
BETTER, RETURN OF RESULTS SOUNDS
MORE SERIOUS.
>>WELL, REPORTBACK SOUNDS MORE
COLLABORATIVE ACTUALLY SO I KIND
OF LIKE THAT.
ANOTHER QUESTION THAT SORT OF
RELATES, IF YOU WERE TO DESIGN A
RESEARCH PROTOCOL IN WHICH YOU
SAID YOU WERE GOING TO EFFECTIVE
ENGAGE THE COMMUNITY AND YOU
WERE GOING TO RETURN RESULTS IN
AN EFFECTIVE MANNER WITH
SOPHISTICATED COMMUNICATION
TECHNIQUES, WHAT WOULD THAT TEAM
LOOK LIKE?
WHO OUGHT TO BE ON THAT RESEARCH
TEAM IN ORDER TO BE ABLE TO
SERVE THOSE FUNCTIONS?
>>I'M A BIG PROPONENT OF MAKING
SURE THAT YOU HAVE PROFESSIONAL
EXPERTISE IN ALL THE AREAS THAT
MATTER.
AND IN MY CASE, IT'S GET A
GRAPHIC DESIGNER OR GET AN
INFORMATION DESIGNER OR BOTH.
TOO OFTEN YOU SEE SCIENTISTS
TRYING TO DEVELOP GRAPHICS THAT
ARE KIND OF HOME GROWN AND MAYBE
THEY'RE NOT SO EFFECTIVE, AND WE
DO A DISSERVICE WHEN WE DON'T
INVEST IN THOSE PROFESSIONALS.
I HAVE SOME MODEST SKILLS OF MY
OWN BUT I ALWAYS WORK WITH
PROFESSIONAL DESIGNERS.
>>WE USE A LOT OF STUDENTS TOO.
WE HAVE STUDENTS DO PRACTICUMS
IN THE AREA OF COMMUNICATION.
WE HAVE SOMEONE THAT KNOWS ABOUT
HEALTH COMMUNICATION, HEALTH
EDUCATORS ARE REALLY IMPORTANT.
WE'RE IN A SCHOOL OF PUBLIC
HEALTH, SO OUT OF OUR STAFF IS
HEALTH EDUCATORS.
AND PEOPLE -- IN THE CASE OF
ECHO, WE NEED SOMEONE THAT KNOWS
ABOUT CHILD DEVELOPMENT, LIKE
CLINICAL PSYCHOLOGISTS, IN OUR
CASE, WE HAVE SOMEONE THAT'S A
PROFESSOR FROM UNIVERSITY AND
SHE COMES WITH OUR STUDENTS.
SO WE GET MORE FOR -- WE GET
MORE HELP.
THEY'RE ABLE NOT ONLY TO EXPLAIN
TO OUR PARTICIPANTS BUT ALSO TO
OUR STAFF WHAT THEY'RE DOING,
AND ON OUR TEAM, WE ALSO HAVE
PEDIATRICIANS.
I'M A SOCIAL WORKER, SO WE HAVE
SOCIAL WORKERS.
WE EVEN HAVE ENGINEERS THAT HELP
US.
AND PARTICULARLY SPECIALISTS IN
ENVIRONMENTAL HEALTH.
IT IMPORTANT TO BE ABLE TO
EXPLAIN THE PARTICULAR
INFORMATION THAT HAS TO DO WITH
THIS TYPE OF RESULTS.
>>I WOULD SAY FROM MY OWN
PERSPECTIVE, I'M IN THE SCHOOL
OF MEDICINE, BUT WE'VE RECENTLY
DISCOVERED THERE'S WHOLE
DEPARTMENTS OF COMMUNICATION ON
CAMPUS AND SOCIOLOGY AND HEALTH
POLICY, AND THESE PEOPLE ARE
ACTUALLY VERY EAGER TO WORK WITH
YOU, BECAUSE IT'S REALLY HARD
AND INTERESTING PROBLEMS FOR
THEM, YOU KNOW, THAT THEY
HAVEN'T HAD THE INVITATION TO
WORK ON.
SO I THINK THERE'S A REAL
OPPORTUNITY FOR MUCH MORE
DIVERSE COLLABORATION AMONG
INVESTIGATORS HERE THAN HAS BEEN
THE TRADITION.
>>I THINK I JUST WANT TO MAKE A
PITCH -- SORRY, I JUST PUSHED
THIS WEIRD BUTTON -- I ALSO WANT
TO MAKE A PITCH THAT IT'S GREAT
TO HAVE A SOCIAL SCIENTIST OR A
COMMUNITY PSYCHOLOGIST ON YOUR
TEAM THAT CAN REALLY HELP YOU
ALSO WITH EVALUATION AND
DEVELOPING INSTRUMENTS DO THAT.
ALSO THINKING ABOUT HOW PEOPLE
ARE HELPING YOU ASSESS TO WHICH
PEOPLE ARE UNDERSTANDING OR
INTERPRESENTING WHAT YOU'RE
TRYING TO CONVEY AND DEVELOP
GOOD PROTOCOLS TO ASSESS THE
DESIGN OF YOUR PRODUCT AND
WHETHER OR NOT IT'S WORKING.
SO I THINK THAT'S VERY
BENEFICIAL.
AND PEOPLE WHO SPECIALIZE IN
DATA VISUALIZATION CAN COME FROM
A VARIETY OF FIELDS.
WE THINK ABOUT THE RISE OF DATA
JOURNALISM THAT PEOPLE WHO ARE
TRYING TO LEVERAGE DATA TO
COMMUNICATE TO PEOPLE AND THE
PUBLIC AND UNDERSTAND DATA, SO I
THINK THERE'S A LOT OF EXPERTISE
OUT THERE THAT CAN BE HELPFUL
DEPENDING ON WHAT KIND OF
REPORTBACK YOU'RE STRIVING TO
DO.
>>I HAVE A QUESTION, ADRIANA,
IN YOUR PRESENTATION, YOU MADE A
DISTINCTION IN TERMS OF SORT OF
HIGHLIGHTING PRIEL OR
ADVERTISING KINDS OF RESULTS TO
RETURN ON THE BASIS OF THERE
BEING LIKE A POPULATION TO
COMPARE TO, AND I'M WONDERING --
SO YOU -- AS ONE EXAMPLE, THE
PROMIS MEASURE, WITH HE ACTUALLY
WE ACTUALLY USETHOSE IN THE ECHD
YOU HAD ANOTHER EXAMPLE TOO.
I'M WONDERING, IS THERE SOME
SORT OF MINIMALLY ACCEPTABLE
NUMBER OF OTHER POINTS THAT YOU
WOULD WANT TO HAVE IN ORDER TO
COMPARE TO, IN ORDER TO USE IT,
YOU KNOW, EFFECTIVELY AND FOR TO
BE SOMETHING THAT YOU WOULD
PRIORITIZE ON THAT BASIS?
>>I DON'T THINK THERE'SNESS
SAIRLY ANY MINIMUM BECAUSE
THERE'S TIMES YOU CAN'T GIVE A
BENCHMARK, IT'S A NEW AREA, THIS
IS WHAT YOU HAVE AND PEOPLE CAN
DEAL WITH THE UNCERTAINTY.
BUT OFTENTIMES WE ARE LOOKING AT
SOMETHING LIKE DEPRESSION
SYMPTOMS.
THERE ARE NUMEROUS MEASURES TO
CHOOSE FROM, AND SO IF YOU ARE
TAKING IN REPORTBACK, RETURN OF
RESULTS, INTO ACCOUNT FROM THE
VERY BEGINNING, THEN THAT CAN
HELP YOUR DECISION-MAKING.
YOU KNOW WHAT, WE'RE GOING TO GO
WITH THIS PROMIS MEASURE BECAUSE
IT GIVES US SOMETHING THAT WE
CAN COMPARE OUR STUDY TO OTHERS
AND WE CAN GIVE PEOPLE SOME
CONTEXT FOR THAT RESULT.
>>MONICA.
>>I HAVE A QUESTION FOR THE
PANEL REGARDING -- SO RIGHT NOW,
YOU WERE TALKING TO REPORTBACK
TO PARTICIPANTS OF STUDIES,
WE'VE GONE THROUGH THE ACTION,
INDIVIDUAL AND COLLECTIVE
ACTION, AND SO I'M WONDERING
WHAT THE PANEL THINKS ABOUT
REPORTING BACK TO OTHER
STAKEHOLDERS WHO MIGHT HAVE --
BECAUSE IN A WAY, IF YOU'RE
REPORTING BACK TO INDIVIDUAL,
THE BURDEN OF PROOF IS PLACED ON
THE GENERAL PUBLIC BECAUSE WE
DON'T NECESSARILY OPERATE UNDER
THE PRECAUTIONARY PRINCIPLE SO
THEN YOU'RE PUTTING THAT -- SO
I'M WONDERING IN JUST ASKING THE
PANEL, WHO ELSE SHOULD BE
RECEIVING THIS TYPE OF DATA AND
HOW SHOULD IT BE COMMUNICATED
BACK AND WHAT MIGHT THAT LOOK
LIKE IF WE'RE TRYING TO ACHIEVE
STRUCTURAL CHANGE WITH THE
FINDINGS OF THESE PROJECTS?
>>I WANT TO SAY IN OUR
EXPERIENCE, WE DO AT LEAST ONCE
A YEAR SOMETIMES TWICE A YEAR,
WE MEET WITH THE PEDIATRICIAN PS
OF THE STUDY AREA.
WE HAVE THE COOPERATION OF ONE
OF THE HOSPITALS, THEY LOAN US
THEIR BIG MEETING SPACE, AND WE
DO LIKE AGGREGATE REPORTBACK TO
THEM.
WE LET THEM KNOW WHAT WE HAVE
FOUND, AND YOU KNOW, WHAT ARE
OUR SUGGESTIONS.
WE LISTEN TO THEM IN TERMS OF
HOW THEY THINK WE CAN IMPROVE
RECRUITMENT OR WHAT WE'RE DOING.
WE ALSO DO A TOUR TO ALL THE
COMMUNITY HEALTH CENTERS.
WE WORK WITH FEDERALLY QUALIFIED
COMMUNITY HEALTH CENTERS.
THIS IS WHERE WE DO OUR
RECRUITMENT AND A LOT OF OUR
FOLLOW-UP.
SO WE GO TO EACH ONE OF THOSE
CLINICS AND WE TELL THEM, THIS
IS WHAT WE'VE BEEN FINDING.
AND OFFER OUR SERVICES IN TERMS
OF PROVIDING INFORMATION TO
THEIR STAFF, HELPING THEM WHEN
THEY HAVE HEALTH FAIRS, SO WE
DEVELOP MATERIALS SO WE CAN GO
WITH THEM TO DIFFERENT
COMMUNITIES.
WE HAVE BEEN ABLE TO SUPPORT
THEM, FOR EXAMPLE, WHEN WE'VE
HAD ONE OF THE MANY HURRICANES
AND CRISES THAT WE'VE HAD.
WE HELP THEM GO TO THE COMMUNITY
AND ESPECIALLY WHEN THERE ARE
THINGS RELATED TO CLEAN WATER OR
SAFE WATER AND THINGS LIKE THAT.
SO IT'S SORT OF LIKE A MUTUAL
RELATIONSHIP BUT THEY REALLY
APPRECIATE A LOT THE FACT THAT
WE COME BACK WITH THE RESULTS,
THAT THEY CAN DO SOMETHING WITH
IT.
THEY CAN EDUCATE THEIR STAFF AND
AT THE SAME TIME THEIR STAFF CAN
EDUCATE THE PATIENTS.
>>CAN I JUST ADD, I THINK
THAT'S A GREAT QUESTION AND IF I
WAS A RESEARCH -- I WOULD THINK
CREATIVELY AND EXPANSIVELY ABOUT
EVERY STAKEHOLDER I COULD TALK
TO.
THINK ABOUT IT NOT JUST IN TERMS
OF TALKING TO PARTICIPANTS AND
THE RESEARCH ACTING ALONE BUT
ACTUALLY IN CONCERT, BECAUSE I
THINK THAT'S GOING TO BE THE
MOST POWERFUL COMBINATION FOR
CHANGE, SO SOME CONTAMINATED
WATER SUPPLY, YOU FIND ALL THE
RELEVANT GOVERNMENT OFFICIALS
AND STAKEHOLDERS AND MEDIA, THE
RESEARCH TEAM SHOULD BE TALKING
TO ALL OF THEM AND THEN THEY
SHOULD TALK TO THE PARTICIPANTS
ABOUT ALSO TALKING TO THEM SORT
OF AS A COMBINED COORDINATED
PRESSURE CAMPAIGN AND I THINK
THAT'S GOING TO BE THE MOST
LIKELY TO ACTUALLY MAKE CHANGE.
>>MONICA, JUST AS A RESPONSE, I
LIKE WHAT BEN SAID, AS A
PROGRAM, ECHO PRIORITIZES
SOLUTION ORIENTED FRAMEWORKS,
AND WE HAVE OUR SYSTEMS AND
PROCESSES FOR STAKEHOLDER
ENGAGEMENT ON THE FRONT END TO
FIGURE OUT WHAT ARE THE SALIENT
RESEARCH QUESTIONS THAT COULD
LEAD TO ACTION, AND ON THE BACK
ENDS, ON DISSEMINATION OF
RESEARCH FINDINGS TO
STAKEHOLDERS.
AND WE DO THAT AT A NATIONAL
LEVEL THROUGH STAKEHOLDER
ORGANIZATIONS AND THEN AS CARMEN
IS SAYING, COHORTS HAVE DONE IT
ON LOCAL LEVELS TOO.
BUT I DON'T THINK WE'VE TACKLED
THE HOW DO YOU INTEGRATE
REPORTBACK TO PARTICIPANTS FOR
THEIR INDIVIDUAL RESULTS WITH
REPORTING TO STAKEHOLDERS FOR
AGGREGATE RESULTS.
WHICH IS MAYBE WHERE YOUR
QUESTION IS GOING.
>>WELL, THERE ARE SOME EXAMPLES
OF THAT.
-- HAS PUBLISHED ABOUT
REPORTING BACK TO WATER
SUPPLIERS AND TO INDIVIDUALS.
ONE THING I THINK IS SO EXCITING
IS TO SEE OUR PARTICIPANTS TAKE
THEIR RESULTS TO THEIR ELECTED
OFFICIALS.
I THINK THIS CONVERSATION ABOUT
WHETHER WE SHOULD HAVE
ENVIRONMENTAL COUNSELORS IS
MAKING ME THINK ABOUT PUBLIC
HEALTH INFRASTRUCTURE, WHICH WE
ALL KNOW IS NOT THE STRENGTH OF
THE UNITED STATES, BUT MANY OF
THESE RESULTS WOULD BE
ACTIONABLE BY LOCAL HEALTH
DEPARTMENTS OR STATE HEALTH
DEPARTMENTS.
>>AN ADDITIONAL THING IS VERY
OFTEN WE DEVELOP MASSIVE
DATASETS RELATED TO EXPOSURE
THAT'S OFTEN SPATIAL, FOR
EXAMPLE.
AND WE CAN, I THINK, LEVERAGE
THOSE DATA AND INTEGRATE THEM IN
WAYS THAT -- TO ALSO DEVELOP
ONLINE TOOLS FOR DIVERSE END
USERS.
SO AN EXAMPLE IS, WE HAVE A
COMMUNITY ENGAGEMENT CORE AT
BERKELEY'S SUPERFUND SITE, AND
WE WERE TRYING TO REALLY
UNDERSTAND VARIABILITY IN
DRINKING WATER QUALITY, BOTH IN
COMMUNITY WATER SYSTEMS ACROSS
THE STATE AND AMONG DOMESTIC
WELL HOUSEHOLDS ACROSS THE
STATE.
SPENT A LOT OF TIME GENERATING
THAT DATA TO DO SOME EPI WORK
BUT WE ALSO DEVELOPED SOMETHING
CALLED THE DRINKING WATER TOOL,
WHICH PUTS THAT ONLINE FOR
DIVERSE END USERS, THE WATER
BOARD HAS BEEN SUPER INTERESTED
IN OUR METHOD ABOUT HOW WE
DEVELOPED IT, AND SO I THINK
IT'S BEEN -- IT'S NOT INDIVIDUAL
LEVEL REPORTBACK, BUT IT IS A
REPORTBACK IN A WAY TO DIVERSE
STAKEHOLDERS, BOTH IN TERMS OF
AGENCY STAKEHOLDERS BUT ALSO
COMMUNITIES THAT ARE INTERESTED
IN DRIPPING WATER QUALITY, AND
IN THIS CASE WE'RE ALSO LOOKING
AT THREATS TO ACCESS DUE TO
DROUGHT.
SO I THINK WE CAN THINK BROADLY
ABOUT HOW WE CAN LEVERAGE A LOT
OF THIS AMAZING DATA THAT WE'VE
GENERATED THAT CAN BE POSTED
ONLINE NOT JUST INDIVIDUAL LEVEL
THAT COULD BE OF USE TO DIVERSE
END USERS AND STAKEHOLDERS.
>>KIM?
>>YEAH, I WAS JUST THINKING
AGAIN ABOUT THE ENVIRONMENTAL
COUNSELORS.
I THINK THAT'S A GREAT IDEA, BUT
I KIND OF ALWAYS GOT STUCK ON
WHO WOULD BE HIRING THEM.
LIKE IF WE STARTED SOME
ENVIRONMENTAL COUNSELING
PROGRAMS AND, YOU KNOW, IT TAKES
THEM A FEW YEARS TO GET THROUGH
THAT, THEY WANT A JOB, AND THE
PROBLEM IS, YOU KNOW, THE
GENETIC COUNSELORS AT ALL MAJOR
COUNSELORS HAVE A GENETIC
COUNSELOR AND IT VERY EMBEDDED
LIKE WITH BRCA1 AND PRENATAL
DIAGNOSIS AND ALL HOSPITALS OF A
CERTAIN SIZE FEEL LIKE THEY NEED
TO HAVE A GENETIC COUNSELOR, BUT
YOU KNOW, IF THIS IS SORT OF
OUTSIDE THAT REALM, I DON'T KNOW
IF STATE DEPARTMENTS WOULD BE
HIRING THE ENVIRONMENTAL
COUNSELORS OR THAT IS WHERE I
ALWAYS KIND OF GET STUCK.
ANYWAY.
>>COULD I BEGIN TO ANSWER THAT
QUESTION?
I DON'T HAVE AN ACTUAL ANSWER
FOR YOU BUT TO REMIND EVERYONE,
GENETIC COUNSELORS WEREN'T EVEN
RECOGNIZED HEALTHCARE PROVIDERS
IN EVERY STATE FOR A LONG TIME.
THAT'S TAKEN A LOT OF EFFORT ON
BEHALF OF NATIONAL ORGANIZATIONS
LIKE NSGC AND OTHERS TO TURN
THAT INTO A REALITY.
SO IT TOOK DECADES TO GET TO THE
POINT WHERE YOU'RE TALKING ABOUT
GENETIC COUNSELORS AS IF THEY
WERE LIKE NOW, YOU KNOW,
STANDARD OPERATING PROCEDURES IN
HOSPITALS, IT JUST WASN'T THAT
WAY AT ALL TIMES.
I'D SAY THIS IS MORE RELEVANT
FOR GOING BACK TO THE EARLY
STAGES OF HAVING GENETIC
COUNSELORS AND MAYBE THERE'S
SOME LESSONS THAT CAN BE LEARNED
THERE THAT CAN BE APPLIED TO
THIS NEW CAREER OR NEW FIELD OF
ENVIRONMENTAL COUNSELING.
>>KIM, IT SEEMS LIKE YOU HAVE A
REALLY GOOD POSITION TO PUSH FOR
SOMETHING LIKE THAT AND START
ORGANIZING THAT.
OF IF YOU CAN HAVE A GENETIC
COUNSELOR AND YOU KNOW THAT
ENVIRONMENT IS COUNTING FOR AT
LEAST PART OF THE OUTCOME OF
THAT GENETIC FINDING, IT SEEMS
LIKE THE HOSPITALS SHOULD BE THE
PLACE WHERE THE COUNSELORS WOULD
BE.
ESPECIALLY GIVEN THE LACK OF ANY
TRAINING IN ENVIRONMENTAL
HEALTH.
>>WE HAVE ONE MORE QUESTION.
OKAY.
WELL, I THINK WE CAN WRAP UP DAY
ONE OF OUR WORKSHOP.
I WANT TO THANK EVERYBODY AGAIN.
WE REALLY APPRECIATE THE TIME
AND ENERGY AND EFFORT YOU PUT
INTO ATTENDING, PRESENTING AND
TO ORGANIZING TODAY.
SO ONE PARTING THOUGHT, WE WILL
RECONVENE TOMORROW AT THE SAME
TIME, AT 9:00, FOR THE SECOND
PART OF THE WORKSHOP.
SO THANK YOU AGAIN, EVERYBODY.
WE REALLY APPRECIATE IT.
>>THANKS FOR YOUR CONTINUED
ENERGY THROUGHOUT THE DAY.
>>YEAH, REMARKABLE.
>>HAVE A GOOD EVENING, EVERYBODY.