>> WELCOME, EVERYONE, TO OUR
INAUGURAL INCLUDE CLINICAL
TRIALS SEMINAR SERIES, FIRST
WEBINAR ON ASSENT AND CONSENT.
NEXT SLIDE.
THANK YOU.
WE HAVE THREE GREAT
PRESENTATIONS, AS WELL AS THE
INDIVIDUAL FROM THE COMMUNITY
GIVING HIS PERSPECTIVE ON
RESEARCH IN DOWN SYNDROME.
I'M DR. LAURIE RYAN, WITH
COLLEAGUE ERIKA TARVER, FROM
NATIONAL INSTITUTE ON AGING.
ERIKA WILL GO OVER THE LOW JUST
TIGS.
>> THANK YOU, LAURIE.
WELCOME TO THE PARTICIPANTS,
WE'RE EXCITED FOR TODAY'S
SESSION AND WEBINAR.
TODAY'S SESSION WILL BE
RECORDED.
AND IT WILL ALSO BE STREAMED
THROUGH VIDEOCAST.
IF YOU'RE NOT ABLE TO
PARTICIPATE FOR THE DURATION OF
THE VIDEOCAST OR FOR TODAY'S
WEBINAR, YOU CAN VIEW IT AS A
FOLLOW-UP ON VIDEOCAST.
ALSO IF YOU ARE IN NEED OF
SPANISH INTERPRETATION, LET US
KNOW.
WE HAVE SEVERAL COLLEAGUES TO
ASSIST WITH THAT.
I WILL TURN IT OVER TO YOU,
LAURIE.
>> RECORDING IN PROGRESS.
>> I'M GOING TO INTRODUCE THE
SPEAKERS.
DR. SHARON KRINSKY McHALE,
HEAD OF LABORATORY OF COGNITION
AND DEVELOPMENT AT THE NEW YORK
STATE INSTITUTE AND COLUMBIA
UNIVERSITY, DR. DAN HOLMES,
UNIVERSITY OF ARIZONA COLLEGE OF
MEDICINE IN TUCSON, DR. ANN
COHEN, ASSOCIATE PROFESSOR OF
PSYCHIATRY, UNIVERSITY OF
PITTSBURGH SCHOOL OF MEDICINE.
SHARON, OVER TO YOU TO GET
STARTED.
>> OKAY.
I THINK I'M UNMUTED.
SO, HISTORICALLY MANY ADULTS
WITH INTELLECTUAL DISABILITY ARE
PRESUMED INCOMPETENT, RESTRICTED
IN OPPORTUNITIES TO MAKE
DECISIONS FOR THEMSELVES
INCLUDING DECISION OF
PARTICIPATING IN RESEARCH.
ALTERNATIVELY, RESULTING IN
ABUSES SUCH AS WILLOW BROOK
STATE SCHOOL, I THINK IT'S AN
IMPORTANT HISTORY LESSON, TO
REMIND US THE MEDICAL DIRECTOR
HERE AT WILLOW BROOK BEGAN THE
HEPATITIS STUDY IN EFFORT TO
UNDERSTAND HOW THE DISEASE
FUNCTIONS AND UTILIZED RESIDENTS
OF WILLOW BROOK, RECEIVED
INFORMED CONSENT THE PARENTS
WERE TOLD THAT THIS WAS
SOMETHING THAT COULD POTENTIALLY
BENEFIT THEIR CHILDREN AND
THEREFORE RECEIVED THEIR FULL
SUPPORT.
WHAT HE DID WAS TO ADMINISTER
THE VIRUS TO UNINFECTED DISEASE,
RESULTING IN BREAKTHROUGH IN
CLASSIFYING STRAINS A AND B AND
THIS LED TO DEVELOPMENT OF
VACCINATIONS.
HE WAS HONORED AS A MEDICAL HERO
BUT SERENDIPITOUSLY, THIS WAS IN
A TIME IN SOCIAL AND CIVIL
HISTORY PRIOR TO CIVIL RIGHTS
FOR ALL PEOPLE INCLUDING THOSE,
ESPECIALLY WITH INTELLECTUAL
DEVELOPMENTAL DISABILITIES.
AS A RESULT OF THIS STUDY, WE
NOW HAVE THE WILLOWBROOK DECREE,
WHICH SAYS THAT RESIDENTS ARE
PROTECTED OR PARTICIPANTS ARE
PROTECTED UNDER EIGHTH AND 14TH
AMENDMENT TO BE FREE FROM
UNETHICAL EXPERIMENTATION AND
EXPOSURE TO HARMFUL ENVIRONMENTS
WITHOUT FULL INFORMED CONSENT.
SO, WHAT I'D LIKE TO DO TODAY IS
HELP YOU GAIN BETTER
UNDERSTANDING OF OVERALL
PERCEPTIONS, ATTITUDES,
IMPEDIMENTS, ASSOCIATED WITH
ENROLLING INDIVIDUALS WITH DOWN
SYNDROME OR OTHER INTELLECTUAL
DISABILITIES, INTO CLINICAL
TRIALS.
SO SOME BASIC CONSIDERATIONS,
INDIVIDUALS WITH ID/DD ARE
POTENTIALLY AT RISK FOR
EXPLOITATION IN THE RESEARCH
PROJECT BECAUSE OF RELATIVE
SOCIAL POWERLESSES NESS AND
OFTEN PERCEIVED AS LACKING
CAPACITY TO PROVIDE INFORMED
CONSENT.
BUT AVOIDING THESE ISSUES VIA
BLANKET EXCLUSION FOR RESEARCH
DENIES THEM THE OPPORTUNITY TO
CONTRIBUTE TO AND TO BENEFIT
FROM RESEARCH.
KATHERINE MCDONALD IS A
RESEARCHER IN OREGON THAT DOES
STUDIES WHICH LOOKS AT THIS
INFORMED CONSENT PROCEDURE.
SHE CALLS ALL THESE PEOPLE ON
THIS SLIDE THE GATE KEEPERS OF
SCIENCE.
THE KNOWLEDGE BASE IS SHAPED BY
240ES THOSE WHO CONDUCT RESEARCH
IN ID/DD AND CONSIDER ITS
ETHICAL INTEGRITY AND WILL HAVE
SUBSTANTIAL INFLUENCE, PLAYING
MAJOR ROLES THAT AFFECT WHAT
TOPICS ARE PURSUED AND HOW
FINDINGS ARE INTERPRETED AND
PRESENTED TO FORM SCIENTIFIC RE.
INTELLECTUAL DISABILITY
RESEARCH, THE PORTRAYAL OF
INDIVIDUALS, WE'RE THE ONES THAT
WRITE THE SCIENTIFIC LITERATURE.
FURTHER, REGULATIONS IMPOSED BY
FDA, IRB COMMITTEES, STATE
GOVERNMENT, THOSE AGENCIES THAT
PROVIDE SERVICES TO PEOPLE WITH
INTELLECTUAL AND DEVELOPMENTAL
DISABILITIES AND DECIDE, SHAPE
WHICH INDIVIDUALS ARE ALLOWED TO
PARTICIPATE IN RESEARCH, AND
TERMS OF THE PARTICIPATION.
THAT ETHICS COMMITTEE SOMETIMES
GO TO SUCH LENGTHS TO AVOID HARM
THAT THEIR REQUIREMENTS
DISCOURAGE RESEARCHERS FROM
ATTEMPTING TO CONDUCT RESEARCH
WITH PEOPLE WITH INTELLECTUAL
DISABILITIES, SO AS SUCH, THESE
ATTITUDES OF THESE GATE KEEPERS
TOWARDS RESEARCH IN CLINICAL
TRIALS IS LIKELY TO BE AN
IMPORTANT FACTOR IN OUR WORK
STARTING CLINICAL TRIALS WITH
INDIVIDUALS WITH DOWN SYNDROME.
SO, WHAT ARE THE GATEKEEPERS?
AT THE FEDERAL LEVEL, FOR
INSTANCE, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES HAS
SOUGHT TO ENSURE GREATER
REPRESENTATIVENESS AND RELIANCE
OF RESEARCH BY MANDATING
INCLUSION OF WOMEN AND RACIAL
MINORITIES, THERE'S NO
CORRESPONDING MANDATES FOR ID/
DD.
THE WILLOWBROOK INSTITUTE
STARTED THAT MOVEMENT NO
RECOGNIZE UNALIENABLE RIGHTS AND
PROMPTED THE 1993 PERMANENT
INJUNCTIONRY REPRESENTED THE
CURRENT STANDARDS OF SERVICE FOR
WHAT THEY CALLED "CLASS
MEMBERS," OR INDIVIDUALS THAT
RESIDED AT WILLOWBROOK.
AT THIS POINT NO PHYSICALLY
INTRUSIVE CHEMICAL OR BIOMEDICAL
RESEARCH OR EXPERIMENTATION CAN
BE PERFORMED WITH WILLOWBROOK
CLASS MEMBERS.
SOME OF THEIR SPECIFICS
REGARDING BEHAVIOR MODIFICATION
AND RESEARCH AND HAZARDOUS AND
EXPERIMENTAL TREATMENT, THEY
SAID THEY RECOGNIZED POSSIBILITY
SUCH RESEARCH OR EXPERIMENTATION
UNDER SAFEGUARDS MAY BE
APPROPRIATE BUT HAVE TO BE
CONDUCTED ONLY AFTER APPROVAL
HAS BEEN OBTAINED FROM THE
INDIVIDUAL, PARENT, GUARDIAN, OR
THREE-PERSON SPECIAL COMMITTEE.
IN NEW JERSEY WE RECRUIT
INDIVIDUALS FROM NEW JERSEY IN
OUR NEW YORK COHORT, UP IN THE
TWEL -- UNTIL 2012 THEY COULD
NOT PARTICIPATE WITHOUT A
GUARDIAN AD LITEM, TO PROTECT A
CHILD'S OR ADULTS INTEREST IN A
SINGLE INSTANCE, COURT
PROCEEDING OR LITIGATION.
WE NOTICED ABOUT 2011, THE
SENATE PASSED A BILL WHICH WAS
SUPPOSED TO ELIMINATE THE
CONFUSION AROUND THIS, AND TO
PERMIT OTHERS TO GIVE CONSENT
FOR RESEARCH, OTHER THAN A
GUARDIAN AD LITEM AND ACTUALLY
OUR GROUP WAS INSTRUMENTAL IN
GETTING IT PASSED IN THE
ASSEMBLY SO IT NEEDED ASSEMBLY
AND SENATE TO PASS IN ORDER FOR
IT TO BECOME LAW.
HOWEVER, WE DO HAVE TO GO
THROUGH ANY KIND OF MEDICAL
RESEARCH HAS TO BE APPROVED BY
THE INTERDISCIPLINARY RESEARCH
COMMITTEE APPOINTED BY NEW
JERSEY DIVISION OF DEVELOPMENTAL
DISABILITIES.
SO THIS IS ONE OF THE GROUPS
THAT PROVIDES SERVICES FOR
INDIVIDUALS IN NEW JERSEY THAT
HAVE DEVELOPMENTAL DISABILITIES.
AS IT CURRENTLY STANDS, THEY CAN
IMPOSE ANY LIMITATIONS ON THE
RESEARCH AND WHAT THEY HAVE DONE
THUS FAR IS ONLY TO APPROVE OUR
MINIMAL RISK PROCEDURES AND SO
AT THIS POINT IN TIME NEW JERSEY
RESIDENTS CANNOT PARTICIPATE IN
OUR PROCEDURES OF PET SCANS AND
LUMBAR PUNCTURES THOUGH WE HAVE
AN APPLICATION TO HAVE THEM
RECONSIDER THIS.
THE LAST STATE, THIS IS JUST TO
SHOW HOW THE STATES HAVE
DIFFERENT RULES AND REGULATIONS,
IN NEW MEXICO A DOCTOR WAS
LEUKEMIA PROGRAM DIRECTOR AND
MASTER CYTOSIS PROGRAM LEADER AT
THE UNIVERSITY OF NEW MEXICO,
AND SHE CONDUCTS CLINICAL TRIALS
IN ACUTE AND CHRONIC LEUKEMIAS.
AND WHEN SHE BECAME ACQUAINTED
WITH GEORGE WHO CAME TO HER
CLINIC AT THE UNIVERSITY OF NEW
MEXICO CANCER CENTER, SHE
THOUGHT HE WOULD BE AN EXCELLENT
IDEAL CANDIDATE FOR NATIONAL
REGISTRY STUDY.
HE HAD BEEN SUCCESSFULLY TREATED
FOR LEUKEMIA IN HIS 30s, LATER
DEVELOPED A SECONDARY LEUKEMIA,
AND SHE WAS INTERESTED IN
GETTING HIS BONE MARROW TO A
BIOBANK TO IDENTIFY MOLECULAR
MECHANISM UNDERLYING THIS IS
CANCER.
GEORGE WAS NOT ELIGIBLE BECAUSE
HIS INTELLECTUAL DISABILITY THAT
WAS RELATED TO HIS DOWN SYNDROME
MADE HIM UNABLE TO COMPLETE THE
STANDARDIZED QUALITY OF LIFE
MEASURE THAT WAS REQUIRED OF THE
PROTOCOL.
AND ALL SHE COULD NOT ENROLL HIM
IN AN INTERVENTION TRIAL EITHER
EVEN THOUGH HIS FATHER AND HIS
SISTER WHO WERE HIS LEGAL
GUARDIANS WANTED HIM TO
PARTICIPATE.
IN THE PEDIATRIC SETTING,
PARENTS MAKE THE DECISIONS, WHEN
WE ARE TALKING ABOUT THE ADULTS
IF PATIENTS ARE UNABLE TO
CONSENT OR FULFILL PROTOCOL
REQUIREMENTS THEY CANNOT BE
ENROLLED EVEN IF TREATMENT IS
POTENTIALLY LIFE SAVING.
A CHALLENGE FOR DEVELOPMENTAL
DISABILITY RESEARCH IS
RESPECTING RIGHTS TO BE TREATED
AS AUTONOMOUS MEMBERS OF
SOCIETY, AND THE NEED TO ENSURE
THAT ILL-FORMED OR INCOMPETENT
DECISIONS WILL NOT PLACE THEIR
WELFARE IN JEOPARDY.
>> WOULD YOU MIND SLOWING YOUR
SPACE DOWN?
WE HAVE COLLEAGUES PROVIDING
INTERPRETATION.
>> I GO INTO MY NEW YORK MODE OF
SPEAKING.
>> THAT'S OKAY.
THANK YOU, I APPRECIATE IT.
>> SO, IT'S TAKEN ME TO THE
15th SLIDE TO GET TO INFORMED
CONSENT, INFORMED CONSENT, THE
INDIVIDUAL MUST HAVE CAPACITY TO
PROVIDE CONSENT, CONSENT MUST BE
GIVEN VOLUNTARILY, CONSENT MUST
BE RELATED TO PROPOSED
INVESTIGATION, TREATMENT, TO BE
INFORMED BY ADEQUATE DISCLOSURE
AND CONSENT MUST NOT BE OBTAINED
THROUGH FRAUD, COERCION, OR
MISREPRESENTATION.
SO THAT GETS US TO THIS ISSUE OF
WHAT IS THE DEFINITION OF
CAPACITY.
THE TERMS, CAPACITY, COMPETENCE,
ARE OFTEN USED INTERCHANGEABLY
BUT THEY DO HAVE DIFFERENT
MEANINGS AND IMPLICATIONS FOR
PEOPLE WITH DEVELOPMENTAL
DISABILITIES.
COMPETENCY IS A GLOBAL
ASSESSMENT.
AND A LEGAL DETERMINATION, WHILE
CAPACITY IS A FUNCTIONAL
ASSESSMENT REGARDING A SPECIFIC
DECISION.
IT REFERS TO MENTAL ABILITY TO
MAKE A PARTICULAR DECISION, AT A
PARTICULAR TIME, QUESTION AND
DECISION SPECIFIC, SHOULD BE
DOCUMENTED, RELATIVE TO EACH
DECISION, CAN VARY ACCORDING TO
SUPPORTS THAT ARE PROVIDED, AND
CAN INVOLVE OTHERS WHO WILL HELP
THE INDIVIDUAL TO MAKE THESE
DECISIONS.
IT'S IMPORTANT TO REMEMBER THAT
IT'S NOT A STATIC ENTITY.
SO AT ONE POINT IN TIME YOU MAY
HAVE CAPACITY, AND LATER ON IN
YOUR PARTICIPATION YOU MIGHT
NOT.
INDIVIDUALS WITH INTELLECTUAL
DISABILITY WE KNOW IT AFFECTS A
RANGE OF COGNITIVE AND ADAPTIVE
ABILITIES.
THERE IS SIGNIFICANT
WITHIN-PERSON VARIABILITY,
COGNITIVE LEVELS OF FUNCTIONING
DO NOT DIRECTLY PREDICT
DIFFERENCES IN LEVELS OF
COMMUNICATIVE, INTERPERSONAL, OR
ACTIVITIES OF DAILY LIVING IN
ADAPTIVE FUNCTIONING.
THOSE WITH INTELLECTUAL
DISABILITIES ALSO HAVE LIMITED
EDUCATIONAL OPPORTUNITIES AND
SOCIAL EXPERIENCES THAT MAY
IMPACT THEIR ABILITY TO CONSENT
FOR RESEARCH.
SO WHO HAS AND DOES NOT HAVE
CAPACITY?
PERSONS 18 YEARS OF AGE AND
OLDER ARE PRESUMED TO HAVE
CAPACITY TO MAKE THEIR OWN
DECISIONS UNTIL THEY ARE SHOWN
NOT TO HAVE SUCH CAPACITY.
HOWEVER, MINORS FOR THE MOST
PART ARE DEEMED TO BE
INCOMPETENT, AS A MATTER OF LAW,
REGARDLESS OF DISABILITY, AND
THEIR PARENTS ARE THE DECISION
MAKERS.
WHEN INFORMED CONSENT IS
REQUIRED IT HAS TO COME WITH
EXPLANATIONS OF THE REASONS THAT
WE'RE ASKING FOR THE CONSENT.
WE HAVE TO PRESENT THE POTENTIAL
BENEFIT OR THE INTENDED OUTCOME
OF THE PROPOSED ACTION OR
PARTICIPATION.
WE HAVE TO BE -- INFORM THEM OF
POTENTIAL RISKS TO THE
INDIVIDUAL AND OTHERS, IF THE
ACTION IS OR IS NOT IMPLEMENTED.
WE HAVE TO GIVE THEM
ALTERNATIVES TO ACTION THAT
MIGHT BE USED AND THE REASONS
FOR CHOOSING THE PLANNED ACTION
AND FINALLY THE RIGHT TO
DISAPPROVE THIS ACTION OR TO
WITHDRAW APPROVAL AT ANY TIME.
JOHNSON, IN OREGON, ACTUALLY
CONDUCTED A STUDY WHICH ASSESSED
UNDERSTANDING AND OBTAINING
CONSENT FROM ADULTS WITH
INTELLECTUAL DISABILITY, BETWEEN
18 AND 65 YEARS, MILD OR
MODERATE ID TO ANSWER QUESTIONS
ABOUT THE KEY ASPECTS OF
STUDIES.
THEY WANTED TO IDENTIFY WAYS IN
WHICH PEOPLE WHO PROVIDED
APPROPRIATE ANSWERS FOR ALL
QUESTIONS DIFFERED FROM THOSE
WHO ARE DIFFICULTY WITH ONE OR
MORE QUESTIONS.
AND THEY WANTED TO EXAMINE
PATTERNS OF RESPONSES TO SEE IF
CERTAIN ISSUES WERE MORE
DIFFICULT TO UNDERSTAND THAN
OTHERS.
SO THEY PILOTED A SHORT SET OF
QUESTIONS, 133 PARTICIPANTS,
AGAIN THEY HAD MILD TO MODERATE
INTELLECTUAL DISABILITY.
SO THEY ASKED, PLEASE TELL ME
WHAT, IN YOUR OWN WORDS, WHAT IS
THE STUDY ABOUT.
WHAT WILL YOU BE DOING IF YOU
TAKE PART IN THE STUDY?
WHAT ARE THE RISKS OF BEING PART
OF THE STUDY?
WHEN I SAY YOU'RE TAKING PART IN
THE STUDY IS COMPLETELY
VOLUNTARY, WHAT DOES THAT MEAN
TO YOU?
WHEN I SAY YOUR ANSWERS WILL BE
KEPT CONFIDENTIAL, WHAT DOES
THAT MEAN TO YOU?
AND WHAT CAN YOU DO IF YOU START
THE STUDY BUT DECIDE THAT YOU
DON'T WANT TO FINISH?
THE RESULTS, TWO INDIVIDUALS
WERE COMPLETELY UNABLE TO ANSWER
ANY OF THESE QUESTIONS.
57% CORRECTLY ANSWERED ALL SIX
QUESTIONS.
96% WERE ABLE TO APPROPRIATELY
DESCRIBE THE STUDY, 88% WOULD
SPECIFY WHAT IT MEANT, THAT THE
DATA WOULD BE KEPT CONFIDENTIAL,
93% WERE ABLE TO EXPLAIN WHAT
VOLUNTARY PARTICIPATION MEANT.
FOR THOSE UNABLE TO ANSWER ALL
THE QUESTIONS, IT WAS IN THE
AREA OF IDENTIFYING POTENTIAL
RISKS THAT THEY THE MOST
CHALLENGE.
SO, CELIA FISHER IN FORDHAM
UNIVERSITY DISCUSSED A GOODNESS
EFFECT FOR INFORMED CONSENT TO
RESEARCH ADULTS, WHICH RESEARCH
INVOLVING ADULTS WITH
INTELLECTUAL DISABILITIES.
SHE INTRODUCED THIS RELATIONAL
ETHICS FRAMEWORK THAT RECOGNIZES
CONSENT, VULNERABLE, AGAIN IN
TERMS OF GOODNESS OF FIT BETWEEN
DECISION CAL CAPACITIES AND
SPECIFIC CONTEXT.
SHE SAID ALL PERSONS ARE UNIQUE
INDIVIDUALS, THUS THE CONSENT
PROCEDURE SHOULD BE BASED UPON
AN UNDERSTANDING OF EACH
PARTICIPANT'S STRENGTH AND
WEAKNESSES, LIFE EXPERIENCES,
AND SOME PRACTICAL CONCERNS.
AND SUCH UNDERSTANDING CAN ONLY
BE ACHIEVED THROUGH THE DEVELOP
MEANT OF VALID AND INDIVIDUALLY
SENSITIVE CONSENT, ASSESSMENT,
AND ENHANCEMENT TECHNIQUES, TO
ENSURE THAT THE CONSENT
PROCEDURES REFLECT AN ETHIC AND
MUTUAL OBLIGATION, RESPECT.
AND WHAT'S SPOKEN ABOUT THESE
DAYS IS THIS WHOLE IDEA OF
AUTHORIZED RESEARCH
REPRESENTATIVE.
SO RESEARCH AS AN IRB MAY SET
DIFFERENT CUT-POINTS FOR LEVEL
OF CONSENT CAPACITY DEPENDING ON
CAPACITY AND RISKS OF GIVEN
STUDY, SO FOR LOWER RISK STUDIES
SOME EVIDENCE OF UNDERSTANDING
EVEN IF IT'S NOT COMPLETE MIGHT
BE DEEMED SUFFICIENT FOR AN
INDIVIDUAL TO PROVIDE INFORMED
CONSENT.
FOR RESEARCH THAT IS GREATER
THAN MINIMAL RISK, SUCH AS
CONDUCTING CLINICAL TRIALS, WITH
THIS POPULATION, INCLUDING
AUTHORIZED RESEARCH
REPRESENTATIVE MAY BE ONE AL
TERN ALTERNATIVE TO EXCLUSION.
TODAY THERE ARE STILL FEW
ETHICAL AND EMPIRICAL GUIDE
POSTS TO CONSTRUCTING RESPECTFUL
PROCEDURES.
THERE'S AN OVERARCHING NEED TO
BE FLEXIBLE, RESPOND TO NEEDS OF
THE PARTICIPANT AND FACILITATE
RESEARCH INCLUDING TO THE
GREATEST POSSIBLE EXTENT WHILE
MAINTAINING HIGH ETHICAL
STANDARDS FOR PROTECTING
RESEARCH PARTICIPANTS FROM HARM.
JUST IN SUMMARY, YOU HAVE TO
BECOME FAMILIAR WITH YOUR
STATE'S POLICIES, AND
REGULATIONS ON RESEARCH WITH THE
ID POPULATION, IT'S IMPORTANT TO
AHEAD OF TIME DISCUSS THE STUDY
DESIGN, PROCEDURES, AND INFORMED
CONSENT PROCESS WITH YOUR LOCAL
IRBs.
YOU ALSO HAVE TO CONTACT YOUR
STATE'S LOCAL OFFICE FOR PEOPLE
WITH DEVELOPMENTAL AND
INTELLECTUAL DISABILITIES TO
DETERMINE THEIR REGULATIONS, AND
PARTICIPATION IN CLINICAL TRIALS
NECESSITATES DEVELOPMENT OF
METHODS TO IMPROVE THE INFORMED
CONSENT PROCESS.
WE MUST BE ABLE TO UNDERSTAND
AND APPLY THE NUANCES OF
INFORMED CONSENT.
MAKING CLINICAL TRIAL ENROLLMENT
PROCESS MORE ACCESSIBLE AND
INCLUSIVE CAN BE A RELATIVELY
STRAIGHTFORWARD PROCESS.
IT'S REALLY A QUESTION OF
FIGURING OUT HOW TO TAILOR YOUR
PROCESS TO ACCOMMODATE THE
POPULATION THAT YOU PLAN ON
WORKING WITH.
BUT IN ACTUALITY, IT CAN BE
DIFFICULT TO DO.
AND BECAUSE THE ISSUE AFFECTS
SUCH A SMALL PERCENTAGE OF THE
OVERALL POPULATION, IT CAN BE
HARD TO GET PEOPLE TO CARE
ENOUGH TO TRY OF WE HOPE TOOLS
AND TRICKS BEING DEVELOPED GO
VIRAL AND NEW INVESTIGATORS WILL
LEARN FROM WORK OF EXPERIENCED
INVESTIGATORS AND PASS ALONG
THAT KNOWLEDGE TO A FEW MORE
RESEARCHERS AND SO ON.
IF YOU HAVE ANY QUESTIONS OR
COMMENTS, PLEASE CONTACT ME.
THIS IS MY INFORMATION.
THANK YOU FOR INVITING ME TO
PRESENT TODAY.
>> THANK YOU, SHARON.
BEFORE WE GO ON TO DAN WE'RE
TAKING QUESTIONS THROUGH THE
CHAT.
WE'LL BE ADDRESSING QUESTIONS
AFTER WE HAVE ALL OF OUR
SPEAKERS GO.
SO PLEASE PUT QUESTIONS IN THE
CHAT IF YOU HAVE THEM.
WE'LL BE TAKING THEM AND
PROVIDING THEM TO THE SPEAKERS
AFTER WE GET THROUGH ALL OF THE
PRESENTATIONS.
ALL RIGHT.
THANK YOU, SHARON.
AND AGAIN LET ME HAND OFF NOW TO
DAN COMBS.
THANK YOU. I'M DAN COMBS,
FOR PEOPLE WITH DOWN SYNDROME,
THAT WAS A BEAUTIFUL OVERVIEW OF
CONSENT.
CONSENT VERSUS ASSENT IS
DIFFERENT.
AND THE FIRST FEW I'LL COVER
ESSENTIALLY GUIDANCE.
INFORMED CONSENT REQUIRED FROM
ALL ADULTS TO BE IN A STUDY,
EQUIVALENT FOR CHILDREN OR
ADULTS WITH LEGAL GUARDIAN,
PARENTAL PERMISSION, USUALLY THE
SAME FORM.
HHS REQUIREMENTS FOR CONSENT ARE
SPELLED OUT.
ESSENTIALLY EXPLAIN WHAT THE
STUDY IS, MAKE SURE PEOPLE
UNDERSTAND WHAT THE STUDY WOULD
INVOLVE, IT'S VOLUNTARY AND THEY
CAN DECIDE IF THEY WANT TO
PARTICIPATE OR NOT.
ASSENT, ON THE OTHER HAND, IS
REQUIRED FROM CHILDREN ACROSS
THE BOARD OR ADULTS UNABLE TO
PROVIDE IT.
UNLIKE CONSENT WHICH HAS PAGES
OF WHAT SHOULD BE INCLUDED, FOR
ASSENT IT'S DEFINED AS
INDIVIDUAL'S AFFIRMATIVE
AGREEMENT TO PARTICIPATE IN
RESEARCH, MERE FAILURE TO OBJECT
SHOULD NOT, AN SENT AFFIRMATIVE
AGREEMENT, BE CONSTRUED AT
ASSENT, AND THAT'S IT.
THERE'S GUIDANCE BUT NOT MUCH
PAST THAT.
WHICH MEANS IT'S ON THE
INVESTIGATOR OR INSTITUTIONAL
REVIEW BOARD TO PROVIDE WHAT TO
BE COVERED, AN OPEN AREA WHICH
IS GOOD AND BAD.
IT'S BAD IN THAT IT'S NOT
(INDISCERNIBLE).
WHEN IS ASSENT NOT REQUIRED?
THERE'S THREE CATEGORIES THAT
HHS PROVIDES, SO IF CAPABILITY
OF SOME OR ALL OF THE
INDIVIDUALS IS LIMITED THAT THEY
CANNOT BE CONSULTED, IN GENERAL
FOR KIDS UNDER 7, FOR PEOPLE
WITH INTELLECTUAL DISABILITY
THIS IS DEPENDENT.
SOME WILL WAIVE IT ACROSS THE
BOARD.
THERE'S A LOT OF HETEROGENEITY
IN THIS.
THE OTHER REASONS, LESS
RELEVANT, IF IT'S AN
INTERVENTION THAT'S GOING TO
DIRECTLY BENEFIT THEM, MEDICAL
CARE NOT OTHERWISE AVAILABLE,
YOU CAN WAIVE ASSENT, PASSIONATE
FOR MEDICAL CARE, WAIVE ASSENT.
AND THEN IF IT'S A WAIVER FOR
THE SAME IN ADULTS --
[AUDIO DISTORTION]
FOR COVERING THE SAME
INFORMATION CONSENT WOULD COVER,
AND OTHERWISE YOUNGER KIDS OR
INDIVIDUALS WITH INTELLECTUAL
DISABILITIES, IT'S REALLY
VARIABLE, BUT THE LAST PUT
POINT, I LIKE THIS EXPLANATION,
WHAT THE EXPERIENCE WILL BE, HOW
LONG WILL IT TAKE, WHETHER IT
WILL INVOLVE PAIN OR DISCOMFORT.
CAPACITY IS ESSENTIALLY DO YOU
UNDERSTAND WHAT'S BEING ASKED,
CAN YOU MAKE DECISIONS.
CAPACITY FOR RESEARCH HAS A
FRAMEWORK, FOUR DOMAINS.
FIRST IS UNDERSTANDING.
WHICH IS WHAT'S GOING TO HAPPEN
IF I'M IN THE STUDY.
THINGS LIKE I'LL TAKE
MEDICATION, I'LL HAVE BLOOD
DRAWN.
APPRECIATION, THIS IS THE NEXT
STEP UP, NOT ONLY DO I KNOW WHAT
WILL HAPPEN BUT HOW DOES THIS
AFFECT ME?
EXAMPLE WOULD BE IF I'M IN THE
STUDY AND THERE'S A BLOOD DRAW
IT MIGHT HURT MY ARM, AND I
WON'T BE ABLE TO GO BOWLING,
WHICH I REALLY LIKE TO DO.
REASONING IS DECIDING DO YOU
WANT TO PARTICIPATE OR NOT, SO
CONSIDERING ADVANTAGES,
DISADVANTAGES, THAT MIGHT BE I
DON'T WANT TO BE IN THE STUDY
BECAUSE THE BLOOD DRAW MIGHT
HURT, OR IT MIGHT HURT BUT MIGHT
HELP SO I WANT TO BE IN THE
STUDY.
FINALLY MAKING DECISIONS.
Y,
YES, I WANT TO BE IN IT, NO, I
DON'T.
ASKING BEFORE YOU SAID YOU
WANTED TO DO THE STUDY, IS THAT
STILL THE CASE?
HELPFUL TO MAKE SURE THIS IS A
CONSISTENT DECISION.
THIS IS RELEVANT FOR PEOPLE WITH
DOWN SYNDROME, DO PARTICIPANTS
HAVE CAPACITY?
CHILDREN UNDER 7 IS MORE OR LESS
ACCEPTED THAT DON'T HAVE
CAPACITY.
SIMILARLY IN POPULATION OF
COMPLETELY NON-VERBAL
INDIVIDUALS, IT WOULD BE
REASONABLE THEY PROBABLY DON'T
HAVE CAPACITY BECAUSE THEY CAN'T
PROVIDE THE DECISION, THINGS
LIKE THAT, IRBs MAY GRANT AN
EXEMPTION FOR THAT REASON.
IN STUDIES BETWEEN 9 AND 12,
UNDER 7 PRETTY MUCH NO CHILDREN
HAVE CAPACITY, OVER 12 MOST IF
NOT ALL TYPICALLY DEVELOPING
CHILDREN HAVE CAPACITY.
AT A STUDY LEVEL THE IRB WILL
DECIDE ASSENT, GET CONSENT FOR
THIS GROUP, OR ASSENT FOR
EVERYONE.
AT THE INDIVIDUAL LEVEL, IT'S UP
TO THE INVESTIGATOR OR STUDY
STAFF.
THERE ARE CAPACITY EVALUATION
INSTRUMENTS, THOSE TEND TO DO
THINGS LIKE TELL ME WHAT'S GOING
TO HAPPEN IN THE STUDY, THINGS
YOU CAN DO INSTEAD OF USING
INSTRUMENT, ARE PARTICIPANTS
PAYING ATTENTION, WATCHING YOU,
SEEM LIKE THEY ARE ENGAGED,
TEACH BACK, TELL ME WHAT WE'RE
GOING TO DO IN THE STUDY, THOSE
ARE SIMPLE EASY APPROACHES TO
GET A SENSE OF CAPACITY FOR ANY
INDIVIDUAL PARTICIPANT.
>> DAN, APOLOGIES FOR
INTERRUPTING.
WOULD IT BE POSSIBLE TO SLOW THE
PACE DOWN FOR OUR SPANISH
INTERPRETERS?
>> YES.
>> THANK YOU.
WE APPRECIATE IT.
>> SORRY.
OKAY.
LOOKING-- THE CHALLENGE OF
ASSENT, I THINK THIS IS AN OPEN
QUESTIONING, HARD TO ANSWER.
WITH ASSENT, WHEN SHOULD IT BE
WAIVED?
WAIVING FOR INFANTS OBVIOUSLY
MAKE SENSE.
BUT THEN AT WHAT POINT, SO
INDIVIDUALS WITH INTELLECTUAL
DISABILITIES, WHEN SHOULD YOU
WAIVE ASSENT, IF YOU REQUIRE
ASSENT FOR EVERYONE, LOWER
FUNCTIONING INDIVIDUALS CAN
POTENTIALLY BE EXCLUDED, SO
NON-VERBAL INDIVIDUALS WHO CAN'T
PROVIDE ASSENT WOULD BE EXCLUDED
SO CAN'T BENEFIT.
ON THE CONVERSE IF YOU WAIVE
ASSENT YOU'RE POTENTIALLY
RISKING A LEVEL OF PROTECTION
FOR PARTICIPANTS AS WELL AS
POTENTIALLY NOT GIVING THEM
RESPECT.
THERE'S THIS BALANCE OF TOO HIGH
A BAR, EXCLUDES PEOPLE.
TOO LOW DOESN'T RESPECT STUDY
PARTICIPANTS.
WITH THAT A FEW DIFFERENT IDEAS
OF GOAL OF ASSENT.
TRADITIONAL FRAMEWORK, IT'S
DECISION MAKING.
DO YOU WANT TO BE IN THE STUDY,
YES OR NO.
SOME PEOPLE ARGUE MAYBE IT
SHOULDN'T BE DECISION MAKING BUT
RESPECT FOR THAT PARTICIPANT,
EXPLAINING THE STUDY, DISCUSSING
THE STUDY.
THE OTHER IDEA, IS ASSENT
PROVIDING PROTECTION?
SO LIKE INFORMED CONSENT TO
PROTECT THE PARTICIPANT, IS
ASSENT HELPING THAT PARTICIPANT
TO MAKE SURE THEY WANT TO BE IN
THE STUDY, WEIGHING THEIR
PERSONAL RISK/BENEFITS.
WITH THAT GOAL, DIFFERENT
INFORMATION IS GOING TO NEED TO
BE INCLUDED IN ASSENT.
SO IT'S DECISION MAKING, GIVE A
LOT OF INFORMATION, MAKE SURE
IT'S UNDERSTOOD.
FOR RESPECT, MORE SIMPLE AS
EXPLAINING THE STUDY, MAKING
SURE YOU CAN BE IN THE STUDY OR
NOT, CAN WITHDRAW ANYTIME.
WITH THAT THERE'S A RANGE OF HOW
MUCH INFORMATION, SO FOR
CLINICAL TRIAL THINGS LIKE
RANDOMIZATION, PLACEBO, ARE
DIFFICULT CONCEPTS.
YOU'LL HAVE A SLEEP STUDY, BLOOD
TAKEN, TAKE MEDICATION, THOSE
ARE MORE STRAIGHTFORWARD.
YOU NEED TO BALANCE GIVING
ENOUGH INFORMATION WITHOUT
OVERWHELMING PEOPLE AND MAKING
SURE IT'S UNDERSTANDABLE.
SO THERE'S GENERALLY FOUR
APPROACHES PEOPLE HAVE PROPOSED.
THE FIRST IS ESSENTIALLY ASSENT
IS MINI CONSENT, IF YOU LOOK AT
THIS DOMAIN, CAPACITY I
MENTIONED PREVIOUSLY, THIS
REQUIRES ALL OF THEM, TO
UNDERSTAND THE INFORMATION, YOU
NEED TO APPRECIATE HOW IT'S
GOING TO AFFECT YOU, USE THAT TO
REASON WHAT WAY YOU WANT TO GO,
AND THEN MAKE A DECISION.
THIS IS THE DEFAULT MOST PEOPLE
GO TO.
I DON'T KNOW THAT IT'S RIGHT
APPROACH.
THIS IS PROPOSED BY A PANEL OF
BIOETHICISTS AND RESEARCHERS,
ASSENT INVOLVES UNDERSTANDING
BASIC STUDY-SPECIFIC
INFORMATION, AND BE ABLE TO
APPRECIATE YOU WHO THE
INFORMATION APPLIES TO YOUR OWN
SITUATION, AND THIS IS MORE
UNDERSTANDING AND APPRECIATION.
SO THIS, AGAIN, I'LL GIVE BLOOD
DRAW, BLOOD DRAW MAY HURT.
YOU NEED TO KNOW WHY YOU'RE
GETTING THE BLOOD DRAW,
UNDERSTANDING WHAT HAPPENS TO
YOU DIRECTLY, ANOTHER PROPOSAL
WOULD BE INDICATE A PREFERENCE
BETWEEN OPTIONS AND BE ABLE TO
COMMUNICATE THESE OPTIONS.
SO THIS DOES REQUIRE MAKING A
DECISION, AS WELL AS FAIRLY HIGH
LEVEL OF UNDERSTANDING, SO WHAT
ARE THE TWO OPTIONS?
WHAT HAPPENS IF I'M IN THE
STUDY?
I'LL TAKE MEDICATION, GET A
BLOOD DRAW, THINGS LIKE THAT.
AND THEN THE LAST OPTION, AGAIN,
ASSENT IS NOT ABOUT DECISION
MAKING, BUT IT'S ABOUT ENGAGING
WITH INDIVIDUALS PRIOR TO
RESEARCH PARTICIPATION.
THE FOCUS HERE IS ON SPEAKING
WITH THE INDIVIDUAL, EXPLAINING
THE STUDY AT THEIR LEVEL OF
UNDERSTANDING, NOT NECESSARILY
DECIDING TO BE IN THE STUDY OR
NOT.
THIS REQUIRES UNDERSTANDING, THE
PARALLEL IN CLINICAL PRACTICE IS
THAT IN CLINICAL CARE FOR
PEDIATRICS, FOR EXAMPLE, IF THE
5-YEAR-OLD IS GOING TO HAVE A
SURGERY YOU'RE NOT TELLING THEM
DO YOU WANT THE SURGERY OR NOT
BUT SAYING YOU'RE GOING TO HAVE
THE SURGERY, HERE IS THE SIDE
EFFECTS, HERE IS WHAT MAY HAPPEN
TO YOU.
IT'S ENGAGING THEM, HELPING THEM
UNDERSTAND WHAT'S GOING TO
HAPPEN, AND GOING FROM THERE.
SO OUR CURRENT APPROACH,
BRIEFLY, SO WE KEEP IT SIMPLE,
POWERPOINT SLIDES ALL RUNLY
QUICKLY, WHAT WILL HAPPEN TO ME,
PROBABLY THE SINGLE BIGGEST TWO,
IS IT VOLUNTARY, YOU CAN
WITHDRAW AT ANY TIME, VERY
IMPORTANT PROTECTIONS
PARTICIPANTS NEEDS TO KNOW,
EMPHASIZING THAT.
HERE IS -- I PULLED OUT HALF
FROM THE CURRENT CLINICAL TRIAL,
MEDICATIONS FOR SLEEP APNEA.
WHAT DOES BEING IN THIS RESEARCH
STUDY MEAN FOR YOU?
THE GOAL IS TO HELP PEOPLE
BREATHE BETTER WHILE THEY SLEEP.
IF YOU SAY IT'S OKAY,
EMPHASIZING IT'S NOT REQUIRED.
MEDICATION FOR SIX MONTHS, WE'LL
WATCH YOU SLEEP FOR TWO NIGHTS,
THERE'S A COUPLE OTHER MEASURES
WE'LL TOUCH ON, BUT, AGAIN, IF
YOU DON'T FEEL COMFORTABLE AT
ANY POINT IN ANYTHING, IT'S OKAY
TO STOP.
YOU CAN ALWAYS ASK TO STOP.
THAT'S REALLY IMPORTANT.
WE EMPHASIZE THAT OVER AND OVER
IN THE PRESENTATION, IT'S
VOLUNTARY.
SO THIS IS WHAT THE SPEECH
DEVICE LOOKS LIKE, A CHILD
WEARING A VEST.
YOU'LL PLAY GAMES, USING AN
IPAD, WHAT THIS LOOKS LIKE.
YOU'LL SPEND THE NIGHT IN A
SLEEP LAB.
WHEN THEY COME FOR THE FIRST
TIME THEY HAVE SEEN THE ROOM
ALREADY.
THEY SIT IN A CHAIR.
THEY WILL PUT STICKERS ON YOUR
HEAD.
THERE'S NO NEEDLES THAT WILL
HURT, EMPHASIZING IT'S NOT
PAINFUL.
AND THEN ONCE YOU HAVE ALL THESE
THINGS ON YOU'LL LOOK LIKE THIS
AND YOU'LL SLEEP LIKE NORMAL.
IN THE MORNING YOU GO HOME.
AND THEN YOU'LL TAKE YOUR
MEDICATION AT HOME EVERY DAY FOR
SIX MONTHS.
SO THAT'S OUR APPROACH, SIMPLE,
HITTING HIGH POINTS.
ONE OF THE IMPORTANT
DISTINCTIONS IS THAT ASSENT
TENDS TO GET TREATED AS AN
EVENT, I'LL HAVE YOU SIGN THIS
PAPER AND GO FROM THERE.
ASSENT IS ABSOLUTELY ONGOING.
THIS IS A KEY PROTECTION FOR
INDIVIDUALS WITH DISABILITIES.
CONTINUING TO BE MONITORED
THROUGHOUT, AND CAN SAY NO, JUST
BECAUSE ASSENT HAS BEEN GIVEN
THEY CAN WITHDRAW AT ANY POINT.
IT'S IMPORTANT THIS DOESN'T NEED
TO BE SOMEONE SAYS NO, I DON'T
WANT TO BE IN THE STUDY, EVEN
NON-VERBAL PARTICIPANTS CAN
EXPRESS THEY DON'T APPROVE OF
SOMETHING.
CRYING, NOT COOPERATING WITH
STUDY PROCEDURES.
THESE ARE ALL SIGNS ASSENT IS
PROBABLY NO LONGER THERE.
THIS IS A TIME TO SIT DOWN WITH
PARENTS, SOMETIMES CRYING FOR
BLOOD PRESSURE WILL PASS, THAT'S
OKAY.
BUT RECOGNIZING THAT, IF YOU
KNOW SOMEONE IS UNCOMFORTABLE
FOR MORE THAN A FEW MINUTES IT'S
BEST THAT WE CHANGE OR IT SHOULD
BE STOPPED AND HAVE THE
PARTICIPANT LEAVE THE STUDY.
THAT'S THE REAL IMPORTANT
PROTECTION THAT HAS TO BE
RESPECTED.
BRIEFLY WE'RE GOING TO BE
STARTING A STUDY LOOKING AT
ASSENT IN PEOPLE WITH DOWN
SYNDROME.
I MENTIONED FOUR APPROACHES TO
ASSENT.
NO DATA IN PEOPLE WITH DOWN
SYNDROME.
WE'RE GOING TO DO A STUDY WITH
TWO MAJOR AIMS.
FIRST, WHAT ARE FAMILY
PREFERENCES.
HOW DO FAMILIES THINK ASSENT
SHOULD BE HANDLED.
WHAT THEIR BELIEFS AND
PREFERENCE IS.
ACTUALLY GOING TO ASSESS
CAPACITY FOR PARTICIPATION IN
PEOPLE WITH DOWN SYNDROME,
THERE'S AN EXISTING TOOL FOR
THAT ARE, THE AUTHOR WAS HELPING
WITH THE STUDY, GOING TO MEASURE
WHAT DOMAINS PEOPLE TEND TO DO
THE BEST FOR CAPACITY AND USE
THAT TO GUIDE HOW CAN WE TAILOR
ASSENT TO SOMETHING THE MOST
UNDERSTANDABLE FOR THE MOST
PARTICIPANTS WITH DOWN SYNDROME,
THE GOAL IS TO MAKE THE PROCESS
MORE MEANINGFUL AND BETTER
ACROSS THE BOARD FOR STUDIES
WITH PEOPLE WITH DOWN SYNDROME.
THAT IS THAT.
THANK YOU.
MY E-MAIL IS HERE.
ANY COMMENTS, PLEASE LEAVE IN
THE CHAT.
ANYTHING ELSE, E-MAIL ME.
I WOULD LOVE TO HEAR YOUR
FEEDBACK.
AND THEN THANK YOU VERY MUCH.
>> THANK YOU, DAN.
WE MOVE TO OUR NEXT PRESENTER
REMINDER SINCE WE HAVE SPANISH
INTERPRETATION PLEASE TRY TO GO
SLOWLY THROUGH THE SLIDES AS WE
SPEAK SO THAT THE INTERPRETERS
CAN KEEP UP.
ALL RIGHT.
ANN, TAKE IT AWAY.
>> THANKS VERY MUCH.
THANK YOU SO MUCH TO THE
PREVIOUS SPEAKERS WHO DID SUCH A
FANTASTIC JOB OUTLINING ISSUES
OF CONSENT AND ASSENT IN DOWN
SYNDROME.
AND IN INTELLECTUAL
DISABILITIES.
I'M GOING TO DISCUSS A LITTLE
BIT RECRUITMENT OF HISTORICALLY
EXCLUDED AND MINORITIZED
POPULATIONS AND HOW THAT APPLIES
TO DOWN SYNDROME RESEARCH, AND
THE ROLE OF INFORMED CONSENT IN
RECRUITMENT OF THESE
POPULATIONS.
SO, WHAT I'M GOING TO TALK ABOUT
FIRST IS IN PITTSBURGH, OUR
EXPERIENCE WITH RECRUITING
UNDERREPRESENTED GROUPS IN STUDY
FOR AGING.
THIS IS REALLY WHERE FROM MY
RESEARCH PERSPECTIVE, WHERE WE
STARTED WITH TRYING TO
UNDERSTAND BETTER RECRUITMENT
STRATEGIES FOR BETTER
REPRESENTATION, IN RESEARCH
COHORTS.
AND SO I HAVE A LARGE
NEUROIMAGING STUDY OF BRAIN
AGING AND COGNITION, THAT
RECRUITED 400 PARTICIPANTS
ACROSS THE SPECTRUM OF AGING
FROM COGNITIVELY UNIMPAIRED TO
ALZHEIMER'S DISEASE, AND OUR
GOALS WERE TO HAVE 50%
REPRESENTATION OF MALES AND
FEMALES, AND 50% OF THE COHORT
BEING AFRICAN AMERICAN.
AND OTHER OUR GOAL WITHIN THIS
WAS TO IDENTIFY PARTICIPANTS WHO
WERE HAVING THEIR FIRST
EXPERIENCE WITH RESEARCH.
THAT WAS REALLY ONE OF OUR
GOALS, WAS TO NOT JUST REACH
UNDERREPRESENTED GROUPS BUT TO
REACH GROUPS WHO HISTORICALLY
WEREN'T PARTICIPATING IN
RESEARCH STUDIES.
AND SO OUR RECRUITMENT SOURCES
WERE FROM OUR ALZHEIMER'S
DISEASE RESEARCH CENTER, WHICH
WAS A VERY TRADITIONAL SORT OF
RESEARCH REGISTRY WITH VERY
TRADITIONAL PARTICIPANTS, THAT
YOU SEE IN CLINICAL TRIALS, AND
RESEARCH STUDIES, AND WE ALSO
UTILIZED COMMUNITY ONLINE
REGISTRY.
I'M GOING TO FOCUS FOR JUST A
MINUTE BEFORE I MOVE TO DOWN
SYNDROME ON THE LESSONS WE
LEARNED FROM RECRUITMENT FROM
THAT COMMUNITY ONLINE REGISTRY.
SO, IN PITTSBURGH WE HAVE A
PROGRAM CALLED PITT PLUS ME.
AND IT IS AN ONLINE REGISTRY
THAT HAS OVER 100,000
INDIVIDUALS WHO SIGNED UP FOR
THE REGISTRY.
IT LARGELY USES SOCIAL MEDIA AND
ONLINE MECHANISMS TO RECRUIT
INDIVIDUALS.
THIS IS AN AD FROM OUR FIRST
STUDY THAT FOCUSED ON
RECRUITMENT OF AFRICAN
AMERICANS.
THE OTHER REALLY NICE THING
ABOUT PITT PLUS ME IS BECAUSE OF
THE ADVERTISING STRATEGIES THAT
INCLUDE SOCIAL MEDIA, COMMUNITY
EVENTS, IT ALLOWED US TO FOCUS
ON INDIVIDUALS WHO HADN'T
PARTICIPATED THROUGH OTHER
MECHANISMS AND ALLOWED FOR
TARGETED RECRUITMENT.
WE FOCUSED IN ONE SPHERE ON
AFRICAN AMERICANS OVER AGE 50,
IN ANOTHER RECRUITMENT SPHERE WE
FOCUSED ON INDIVIDUALS WITH HIGH
SCHOOL EDUCATION OR LESS,
PRIMARILY INDIVIDUALS WHO ARE
UNDERREPRESENTED IN RESEARCH
STUDIES.
WHAT THIS ALLOWED US TO DO WAS
TO REALLY WORK WITH THE
COMMUNITY TO SORT OF BUILD A
NETWORK TO BUILD LONG-TERM
RELATIONSHIP WAS TRUST PARTNERS
RATHER THAN GENERAL STRATEGY
THAT HAS HAPPENED WHERE YOU HIT
AND RUN, FOLKS PARTICIPATE IN
RESEARCH STUDY, NOT MUCH
INTERACTION WITH THE COMMUNITY.
THROUGH PITT PLUS ME AND
PARTICIPANTS WE WERE ABLE TO
PARTNER WITH OUR COMMUNITY
ENGAGEMENT CENTERS, WHERE WE
ATTEND -- WHERE OUR RESEARCHERS
AND STAFF ATTEND MEETINGS, THESE
COMMUNITY ENGAGEMENT CENTERS IN
PITTSBURGH HAVE MADE COMMITMENTS
TO THE NEIGHBORHOODS WITHIN
PITTSBURGH THAT HAVE BEEN
HISTORICALLY EXCLUDED.
AND WE JUST BECAME PART OF THE
COMMUNITY.
WE ATTENDED THE DINNERS,
ATTENDED EVENTS, AND WE DIDN'T
NECESSARILY DURING THAT TIME
RECRUIT PARTICIPANTS.
RATHER, WE GOT TO KNOW THE
INDIVIDUALS WITHIN THE
COMMUNITY, PROVIDED READ SOURCES
LIKE INFORMATION ABOUT AGING AND
DEMENTIA, AND WHAT MY INTEREST
BECAME AFTER DOING THIS WAS THIS
IDEA OF HOW CAN WE APPLY THIS TO
OTHER COMMUNITIES.
AND SO A COUPLE OF THE THINGS
WE'VE LEARNED, FIRST IS WE HAVE
TO BE MORE FLEXIBLE IN OUR
TYPICAL CLINICAL TRIALS.
WE FOUND THAT AMONG THESE
PARTICIPANTS WHO HAVE NOT
PREVIOUSLY PARTICIPATED IN
RESEARCH, THERE'S NOT ALWAYS A
CONSISTENT MEANS OF CONTACT.
SO THESE ARE INDIVIDUALS WHO
FREQUENTLY CHANGE PHONE NUMBERS,
DON'T HAVE RELIABLE INTERNET
ACCESS, AND SO KEEPING CLOSE
CONTACT WITH INDIVIDUALS SO THAT
WE CAN MAINTAIN THOSE
RELATIONSHIPS WAS QUITE
DIFFERENT THAN OUR EXPERIENCE
WITH OUR ADRC, CLINIC-BASED
PARTICIPANTS.
WE HAD TO BE CREATIVE WITH
SCHEDULING, PROVIDING
INDIVIDUALS WITH EARLY MORNING,
EVENING, AND WEEKEND
APPOINTMENTS.
WE'VE ALSO FOUND THAT WHEN WE
CAN, WE USE TRUSTED LOCATIONS
FOR PROCEDURES THAT DON'T HAVE
TO BE AT A RESEARCH CENTER.
WE CAN'T BRING NEUROIMAGING
EQUIPMENT INTO THE COMMUNITY BUT
CAN GO IN THE COMMUNITY TO DO
SOME COGNITIVE TESTING AND TO DO
BLOOD DRAWS.
WE ALSO HAVE LEARNED THAT WE
NEED TO HAVE A RESPECTFUL
EDUCATION PROCESS ABOUT RESEARCH
PROCEDURES, SO WHAT DOES THAT
MEAN?
WELL, FIRST, THERE'S BEEN A LOT
OF DISCUSSION ABOUT WHAT
PARTICIPANTS WILL AND WON'T DO,
THERE'S ASSUMPTIONS MADE ABOUT
PARTICULAR COMMUNITIES BEING
UNWILLING TO DO PARTICULAR
PROCEDURES, BUT ONE OF THE
THINGS THAT WE'VE LEARNED AND
THIS IS OUR WALK INTO THE
INFORMED CONSENT IN A MINUTE,
PART OF THIS TRUST-BUILDING
PROCESS IS TO SPEND TIME
EXPLAINING WHY A PROCEDURE IS
NEEDED, RATHER THAN JUST
ASSUMING THAT WE WILL TELL
PARTICIPANTS, OH, THIS PROCEDURE
IS OPTIONAL AND YOU DON'T HAVE
TO DO IT.
SEVERAL TIMES FROM INDIVIDUALS
IN THE COMMUNITIES WE HEARD THAT
I ASSUMED IF THE PROCEDURE IS
OPTIONAL, IT'S NOT IMPORTANT.
AND SO ONE OF THE THINGS THAT WE
LEARNED WAS OUR INITIAL
ASSUMPTION WAS WE'LL TELL
PARTICIPANTS THEY DON'T -- THAT
A PET SCAN IS OPTIONAL BECAUSE
THEY DON'T WANT RADIATION
EXPOSURE, AND PARTICIPANTS WERE
ACTUALLY PUT OFF BY THAT BECAUSE
WHAT THEY WANTED TO HEAR WAS
WHAT WILL YOU LEARN FROM THE PET
SCAN?
WHY IS THE PET SCAN IMPORTANT?
AND THEN THEY CAN MAKE AN
INFORMED DECISION RATHER THAN
THIS ASSUMPTION IF IT'S OPTIONAL
IT MUST NOT BE IMPORTANT.
SO, HOW CAN WE BEGIN TO APPLY
SOME OF THESE STRATEGIES TO DOWN
SYNDROME RESEARCH?
WELL, IT ALL COMES DOWN TO
COMMUNITY ENGAGEMENT.
HERE I'M GOING TO REALLY FOCUS
IN ON INFORMED CONSENT BECAUSE
THAT'S WHAT TODAY'S WORKSHOP IS
ABOUT.
I JUST WANTED TO MENTION SOME OF
THE OTHER FACTORS THAT ARE
REALLY CRITICAL AND ABC-DS,
ALZHEIMER'S BIOMARKER CONSORTIUM
AND DOWN SYNDROME STUDY IN OUR
COMMUNITY ENGAGEMENT EFFORTS
WHAT WE'RE REALLY WORKING TO DO.
THE FIRST THING IS ENSURING
COMMUNITY MEMBERS WITH DOWN
SYNDROME AND THEIR FAMILY
MEMBERS AND OTHER STAKEHOLDERS
HAVE A SEAT AT THE TABLE.
SO, SEEKING FEEDBACK AT EVERY
STAGE OF RESEARCH, SO FROM
ADVERTISING AND STUDY DESIGN,
INFORMED CONSENT, PROCEDURES,
SETTING IN LOCATION OF THOSE
RESEARCH PROCEDURES.
WE HAVE TO ACKNOWLEDGE THAT THE
TRADITIONAL SOURCES OF DOWN
SYNDROME RECRUITMENT HAVE MOSTLY
FAILED TO ENGAGE DIVERSE
COMMUNITY MEMBERS.
SO, WE KNOW THAT GOING TO ONLY
SUPPORT GROUPS AND CONFERENCES
AND SPECIALIZED CARE PROVIDERS
OFTEN EXCLUDES A LARGE NUMBER OF
PEOPLE WHO ARE GETTING CARE IN
THEIR COMMUNITIES, WHO MAY NOT
BE ABLE TO AFFORD TO ATTEND
CONFERENCES OR FOR A VARIETY OF
REASONS MAY NOT BE ABLE TO BE AS
DIALED INTO THE COMMUNITY AS
OTHERS ARE.
THIS IS REALLY ABOUT MEETING THE
COMMUNITY WHERE THEY ARE.
WE HAVE TO IDENTIFY HOW RESEARCH
CAN BE A SERVICE TO THE
COMMUNITY AND I'LL COME BACK TO
THIS IN A MINUTE IN THE
DISCUSSION OF INFORMED CONSENT
PROCESS BECAUSE THIS IS A PLACE
WHERE THIS SHOULD BE A
DISCUSSION.
THESE COMMUNITIES INCLUDING THE
INTELLECTUAL DISABILITY
COMMUNITY ARE ACUTELY AWARE OF
THIS HIT AND RUN APPROACH.
DR. KRINSKI-McHALE MENTIONED
PAST EVENTS THAT LEFT
INTELLECTUAL DISABILITY
COMMUNITY AND UNDERREPRESENTED
GROUPS AWARE OF RESEARCHERS
TAKING AND NOT PROVIDING BACK TO
THE COMMUNITY.
WE HAVE TO IDENTIFY CHALLENGES
AND BARRIERS TO PARTICIPATION.
COSTS THAT ARE BOTH MONETARY AND
TIME.
AND THEN FINALLY, ACKNOWLEDGING
THAT THESE FACTORS DIFFER IN
DIFFERENT COMMUNITIES, AND THAT
WE CAN'T TAKE IN A A
ONE-SIZE-FITS-ALL APPROACH,
SOMETHING I'LL TALK ABOUT IN A
MINUTE, A LOT OF INFORMATION WE
HAVE ABOUT INFORMED CONSENT AND
ASSENT DOESN'T COME FROM
INTELLECTUAL DISABILITIES
COMMUNITY.
IT COMES FROM RESEARCH IN OTHER
GROUPS.
DR. COMBS' NEW STUDY WILL BE
LOOKING SPECIFICALLY AT THE DOWN
SYNDROME COMMUNITY, THIS IS VERY
IMPORTANT TO RECOGNIZE THAT JUST
BECAUSE SOMETHING HAS WORKED IN
A NEUROTYPICAL COMMUNITY OR
AGING COMMUNITY, THAT IT LIKELY
WILL HAVE TO BE MODIFIED TO
SUPPORT THE DOWN SYNDROME
COMMUNITY.
WHAT ABOUT INFORMED CONSENT?
WHAT ARE BARRIERS, MOST RESERVE
DOESN'T COME FROM INTELLECTUAL
DISABILITIES COMMUNITY ON
BARRIERS TO CONSENT AND
RESEARCH.
WHAT I'M MOSTLY TALKING ABOUT
HAS BEEN DONE IN THE
NEUROTYPICAL COMMUNITY BUT
RECENTLY THREE FACTORS HAVE BEEN
IDENTIFIED REAL BARRIERS TO
CONSENT IN RESEARCH PARTICULARLY
AMONG MINORITIZED RESEARCH.
THE FIRST IS EXISTING TRUST.
WHAT KIND OF TRUST DOES THE
COMMUNITY HAVE IN YOU AND YOUR
RESEARCH TEAM?
AND ONE QUOTE WAS AN INDIVIDUAL
TALKING ABOUT HOW ONCE YOU GIVE
BLOOD AND YOU PROVIDE CONSENT
FOR SOMETHING TO BE BIOBANKED,
THAT YOU DON'T KNOW WHAT HAPPENS
TO THOSE SAMPLES AFTERWARDS.
THAT YOU NEVER KNOW WHAT'S
HAPPENING IN THE LABORATORY.
THERE'S A LOT OF CONCERN AMONG
INDIVIDUALS WHEN YOU TALK --
WHEN YOU GO THROUGH INFORMED
CONSENT AND TALK ABOUT THE LACK
OF COMPLETE CONFIDENTIALITY, AS
MANY OF US KNOW IN INFORMED
CONSENT DOCUMENTS WE ASSURE
INDIVIDUALS WE WILL DO
EVERYTHING TO PROTECT
CONFIDENTIALITY BUT THEN WE ALSO
SAY, AS WE'RE REQUIRED TO DO,
THAT THAT CAN'T BE COMPLETELY
PROTECTED, THAT THERE ARE EVENTS
THAT MAY CAUSE BREACHES IN
CONFIDENTIALITY.
THIS IS SOMETHING THAT
INDIVIDUALS FIND CONCERNING AND
SEE AS A CONTRADICTION.
THE PARTICIPANTS IN THIS STUDY,
THESE FOCUS GROUPS, ALSO
MENTIONED THAT THEY REALLY FEEL
THAT THERE'S AN IMPORTANT ROLE
FOR TRUSTED PARTNERS IN THE
CONSENT PROCESS SO IT MAY NOT BE
JUST A PARTICIPANT AND
RESEARCHER IN THE ROOM,
SOMETIMES IT MAY BE IMPORTANT TO
IDENTIFY A TRUSTED PARTNER, A
CARE PROVIDER FROM WITHIN THE
COMMUNITY, WHO CAN ALSO HELP
WITH INTERPRETATION OF THAT
INFORMED CONSENT.
THE SECOND FACTOR THAT HAS BEEN
DISCUSSED AS A BARRIER IN
MINORITIZED COMMUNITIES IS HOW
THE COMMUNITY WAS ENGAGED.
IF YOU'RE STUDYING AN AFRICAN
AMERICAN COMMUNITY, IS THERE A
SPECIFIC BENEFIT OF THE RESEARCH
TO THE AFRICAN AMERICAN
COMMUNITY, AND WHAT ARE THOSE
BENEFITS AND HOW ARE THEY
DESCRIBED?
WAS THE COMMUNITY ENGAGED IN THE
DEVELOPMENT OF THE RESEARCH
STUDY?
THIS HAS BECOME ESPECIALLY
CRITICAL.
AND RETURN OF RESEARCH RESULTS,
THIS IS ANOTHER PIECE OF
ENGAGEMENT THAT PARTICIPANTS
FIND VERY IMPORTANT AND
FRUSTRATING BUT THEY MAY LOSE
OWNERSHIP OF THE -- MAY LOSE
OWNERSHIP OVER THEIR RESEARCH
RESULTS ONCE THEY ENROLL IN A
RESEARCH STUDY.
FINALLY, AS WE ALL THINK ABOUT
FREQUENTLY, IS BUILDING TRUST
INTO THE PROCESS, AND THIS IS A
PLACE WHERE COLLEAGUES DISCUSS
IDEA OF LENGTHENING CONSENT
PROCESS, SO INSTEAD OF THE DAY
OF THE RESEARCH PROCEDURE HAVING
INDIVIDUALS COMING IN TO DO
INFORMED CONSENT, IT BECOMES AN
ITERATIVE PROCESS.
I'LL TALK ABOUT THIS MORE IN
JUST A SECOND.
WHAT HELPS WITH CONSENT
UNDERSTANDING?
IN SOME STUDIES IT'S IDENTIFIED
IN MINORITIZED POPULATIONS SOME
OF THE TERMS WE USE ACTUALLY
AREN'T AT ALL FAMILIAR TO
INDIVIDUALS IN THE LAY
COMMUNITY, AND THAT WHAT WE
THINK IS PLAIN LANGUAGE IS NOT
PLAIN LANGUAGE.
SO, LESS THAN HALF OF
INDIVIDUALS IN THIS PARTICULAR
RESEARCH STUDY WERE ABLE TO
CORRECTLY IDENTIFY WHAT A DOUBLE
BLIND STUDY WAS, NON-INVASIVE,
PLACEBO, EVEN WORDS LIKE
ANONYMOUS AND CONFIDENTIAL.
SO REALLY THINKING ABOUT THE
LANGUAGE IN YOUR CONSENT FORM
AND HOW IT CAN BE AS ACCESSIBLE
AS POSSIBLE IS REALLY A CRITICAL
PIECE TO ENGAGING WITH
COMMUNITIES IN APPROPRIATE AND
CULTURALLY COMPETENT WAY.
INTERESTINGLY IN THE SAME STUDY,
THEY LOOKED AT WHAT RESEARCHERS
FREQUENTLY DO FOR INFORMED
CONSENT, VERSUS WHAT COMMUNITY
MEMBERS MIGHT THINK WAS HELPFUL,
AND SO SOME THINGS THAT WE'RE
FAMILIAR WITH LIKE TAKING THE
INFORMED CONSENT HOME, SENDING
IT OUT TO INDIVIDUALS, A
ONE-ON-ONE DISCUSSION WITH AN
INDIVIDUAL, THOSE WERE THINGS RE
RESEARCHERS DO AND COMMUNITY
MEMBERS FIND IMPORTANT.
ONE THING THAT WAS INTERESTING
TO ME IS THAT COMMUNITY MEMBERS
FELT LIKE THINGS LIKE VIDEOS AND
GROUP DISCUSSIONS MAY BE QUITE
HELPFUL IN THE INFORMED CONSENT
PROCESS BUT THOSE WERE THINGS
RESEARCHERS VERY INFREQUENTLY DO
IN TERMS OF INFORMED CONSENT.
IT'S INTERESTING STRATEGY WHERE
SOME INDIVIDUALS READ THE
CONSENT TO A PARTICIPANT IS NOT
VIEWED TO BE EFFECTIVE BY
COMMUNITY MEMBERS, THAT'S NOT AT
LEAST IN MY OPINION SURPRISING.
THE LAST THING THAT I WANTED TO
TALK ABOUT HERE WAS THIS NEWLY
PUBLISHED INTERVENTION STRATEGY
CALLED STRIDE, WHICH STANDS FOR
STRENGTHENING TRANSLATIONAL
RESEARCH IN DIVERSE ENROLLMENT.
THIS WAS JUST PUBLISHED LAST
YEAR.
THERE AREN'T RESULTS FROM THE
STUDY YET BUT THE PROTOCOL HAS
NOW BEEN PUBLISHED.
AND ONE OF THE THINGS THAT THIS
STUDY UTILIZES IS MULTIPLE
PRONGS.
FIRST PRONG IS TO TRAIN RESEARCH
ASSISTANTS IN A CULTURALLY
COMPETENT MANNER IN A WAY THAT
IS ACCESSIVE.
ONE THING UTILIZED ARE
STORY-TELLING VIDEOS, THERE'S A
LOT OF INFORMATION IN
NEUROTYPICAL POPULATIONS IN
LITERATURE THAT STORY-TELLING
VIDEOS AND STORY TELLING OVERALL
IN MINORITIZED POPULATIONS IS A
QUITE EFFECTIVE RECRUITMENT
STAGE AND WAY OF SHARING
INFORMATION WITH MINORITIZED
COMMUNITIES.
THIS USES STORY-TELLING VIDEOS
IN THE INFORMED CONSENT PROCESS
THAT INTERACT WITH e-CONSENT
PLATFORM, INSTEAD OF HAVING A
PAPER CONSENT FORM THESE
INDIVIDUALS HAVE ACCESS PRIOR TO
THE DAY OF CONSENT AND DURING
THE CONSENT TO BE A INTERACTIVE
PLATFORM TO HAVE STORY TELLING
ABOUT A PARTICULAR PROCEDURE, TO
GET MORE INFORMATION ABOUT THE
PROCEDURES THAT THEY ARE
GETTING.
AND SO INSTEAD OF IT JUST BEING
CONVERSATIONAL, THERE'S ACTUALLY
MULTIMEDIA TOOLS.
IN THE ALZHEIMER'S BIOMARKER
CONSORTIUM WE WERE FUNDED TO DO
SOME OF THE SAME SORT OF
RESEARCH ASSISTANT TRAINING WITH
CULTURAL COMPETENCY AND THE
COMMUNITY, SO WE'RE HOPEFUL THAT
WE WILL WILL BE ABLE TO ADD TO
THIS BODY OF LITERATURE BY
EXPLORING THE RELATIONSHIP
BETWEEN -- EXPLORING HOW WELL
TRAINING OUR RESEARCH STAFF
WORK, HOW WELL THAT WILL WORK IN
RECRUITMENT OF UNDERREPRESENTED
INDIVIDUALS.
SO, IN SUMMARY, WE REALLY HAVE
TO THINK OF COMMUNITY ENGAGEMENT
AS AN ONGOING PROCESS.
THERE'S NOT GOING TO BE A
ONE-SIZE-FITS-ALL APPROACH.
CONSENT AS WITH OTHER PROCEDURES
NEEDS TO BE ONGOING AND
INTERACTIVE PROCESS.
UTILIZATION OF STORY-TELLING AND
COMMUNITY PARTNERS MAY BE A VERY
EFFECTIVE STRATEGY IN BUILDING
TRUST, NOT ONLY IN RECRUITMENT
BUT ALSO IN INFORMED CONSENT.
TRAINING OF TEAM MEMBERS IN
CULTURAL COMPETENCY IS KEY,
AGAIN BOTH FOR RECRUITMENT AND
INFORMED CONSENT, AND THEN
FINALLY DEMONSTRATING BENEFIT TO
SPECIFIC COMMUNITY THAT YOU'RE
REACHING TO IS CRITICAL AND THIS
IS REALLY SOMETHING THAT CAN BE
TIED IN NOT JUST TO RECRUITMENT
BUT ALSO TO THE INFORMED CONSENT
PROCESS.
SO THANK YOU VERY MUCH FOR
LISTENING.
IF YOU HAVE ANY QUESTIONS,
PLEASE FEEL FREE TO E-MAIL ME OR
REACH OUT TO ME ON TWITTER.
>> THANKS TO THE FIRST THREE
SPEAKERS.
I'LL TURN IT OVER TO ERIKA FOR
THE NEXT PORTION OF THE WEBINAR.
>> THANK YOU.
TO ECHO LAURIE'S POINTS, THANK
YOU TO THE FIRST THREE SPEAKERS.
WE'RE LOOKING FORWARD TO THE
DISCUSSION PORTION AND TO KICK
OFF OUR DISCUSSION PORTION WE
HAVE A SELF-ADVOCATE, TONY.
IF YOU'RE ON, IF YOU'RE ABLE TO
TURN ON YOUR CAMERA AND UNMUTE
YOURSELF, AS YOU'RE DOING THAT
I'LL PROVIDE A LITTLE BIT OF
INFORMATION TO OUR PARTICIPANTS
ON TONY.
TONY IS A 48-YEAR-OLD INDIVIDUAL
WHO LIVES IN NEW IBERIA,
LOUISIANA.
ACTIVE MEMBER OF NATIONAL DOWN
SYNDROME CONGRESS AND TONY HAS
SERVED ON THE NATIONAL DOWN
SYNDROME CONGRESS BOARD OF
DIRECTORS AND SELF- ADVOCATE
COUNCIL.
ONE OF HIS FAVORITE THINGS ABOUT
SERVING ON THE BOARD IS HE'S
ABLE TO SERVE AS A VOICE FOR
EVERYONE THAT MAY NOT HAVE THE
GIFT OF SPEAKING.
TONY IS INVOLVED WITH SEVERAL
COUNCIL PROJECTS INCLUDING BOOK
PROJECT, ADVOCACY TRAINING BOOT
CAMP, SERVING AS KEYNOTE SPEAKER
AND WORKING WITH LEADERSHIP TO
DEVELOP AND IMPROVE WORKSHOPS AS
WELL AS WORKING ON THE CONGRESS'
GREETERS PROGRAM AND STAFFING
SOME SELF-ADVOCATE INFORMATION
TABLE AT THE CONVENTION, A
FORMER BOARD MEMBER AND ADVOCATE
AND MOTIVATIONAL SPEAKER FOR
LOCAL DOWN SYNDROME
ORGANIZATION, DOWN SYNDROME
ASSOCIATION ACADENA, INVOLVED IN
SPECIAL OLYMPICS FOR THE STATE
OF LOUISIANA, ALSO A PROUD EAGLE
SCOUT.
TONY, WELCOME.
WE'RE HONORED TO HAVE YOU WITH
US TODAY.
>> THANK YOU VERY MUCH.
AND TO ALL OF YOU.
>> GREAT.
PLEASE GO AHEAD.
>> THANK YOU FOR THE BEAUTIFUL
PRODUCTION OF ME, WHICH IS SO
BEAUTIFUL.
MY PORTION, WHEN WE HAD THE NIH
AT THE 50th ANNIVERSARY, JUST
PREVIOUSLY THESE ARE SOME OF THE
ANSWERS THAT WE HAD TRAINED AND
WENT THROUGH A LOT OF.
>> ABSOLUTELY.
JUST TO START OFF, WE DO HAVE A
COUPLE QUESTIONS, AND THIS GOES
INTO SOME OF THE POINTS THAT OUR
THREE SPEAKERS PRESENTED.
THERE ARE A FEW QUESTIONS, TONY,
THAT I'LL ASK YOU.
IF YOU DON'T MIND ANSWERING.
>> SURE.
>> SO, THE FIRST QUESTION THAT
WE HAVE IS, TONY, COULD YOU
PROVIDE US WITH A LITTLE BIT OF
BACKGROUND ABOUT WHAT'S BEEN
YOUR EXPERIENCE WITH TAKING PART
IN CLINICAL RESEARCH.
>> WELL, IN THE MOST IMPORTANT
PART OF MY PART OF MY LIFE, WITH
THE CLINICAL RESEARCHERS, THAT I
HAVE HAD AND BEEN, YOU ARE ABLE
TO SEEK OUT AND APPROVE THAT
YOU'RE NOT ALONE.
>> UH-HUH.
>> AND WITH THAT PROVEN FOR THAT
FACT, THE IMPORTANCE OF LIVING A
NORMAL LIFE, AS OTHERS WOULD DO,
DOING UNTO OTHER PEOPLE AROUND
YOU, THAT IT'S CRITICAL AND IT'S
IMPORTANT TO KNOW YOU ARE LIVING
RESPECTFUL ADULTS, GIVING BACK.
THAT CAN BE ANYTHING.
NOT JUST TO GIVE BACK BUT THE
IMPORTANCE, CRITICAL PART OF
LIVING A FULL ACCEPTED LIFE.
AND I STILL DO THAT, AND IT'S SO
INCREDIBLE THAT I'M A BIG PART
OF THAT, NO MATTER WHICH WAY.
THE PROFESSIONALS HERE, OUR
ADMIRATIONS ARE ALWAYS
COMMENDABLE, NO MATTER WHAT OR
WHERE OR HOW OR WHY.
AND THAT'S HOW I FEEL TOO.
THAT'S THE IMPORTANCE OF GIVING
THAT BACK.
WE'RE RELYING ON OTHER PEOPLE,
WE'RE A BIG COMMUNITY, AND SO
MUCH MORE BECAUSE THIS IS
WORLDWIDE.
SO, YES.
>> PERFECT.
WELL, THANK YOU.
AND YOU KNOW, RESEARCH IS NOT
POSSIBLE WITHOUT PARTICIPANTS.
SO WE THANK YOU FOR WHAT YOU AND
YOUR FAMILY HAVE BEEN DOING WITH
RESEARCH.
SO, I KNOW THE LAST TIME THAT WE
TALKED, YOU MENTIONED THAT YOU
PARTICIPATED WITH THE NATIONAL
DOWN SYNDROME CONGRESSES, DURING
THE MEETINGS CRNIC INSTITUTE
HUMAN TRISOMY PROJECT.
TELL US WHAT YOU ENJOYED OR WHAT
DID YOU LIKE ABOUT PARTICIPATING
IN THAT CLINICAL RESEARCH.
>> WELL, THE CLINICAL RESEARCH
YES, NUMBER ONE, WE ARE PROBABLY
THE BIGGEST STAFF, MEDICAL AND
WHOEVER ELSE IS IN THIS BIGGER
PICTURE, THAT WE HAVE GROWN TO
BE EXCITED BUT YET INFORMATIONAL
AT THE SAME TIME.
WE CAN'T FORGET THAT PART OF
NOT -- OF THE ACCEPTANCE PART,
BUT ALSO SO MUCH MORE AFTER.
AND WE CAN'T ENOUGH OR DO ENOUGH
TO RELY ON THAT.
WITH THE INFORMATION WE GET AND
SHARE, IT'S IMPORTANT TO OUR
SOCIETY, WHERE WE ARE IN OUR
LIFE, HOW WE GOT THE ACTIVITY,
OR THE ACTIVITIES IN OUR LIVES,
WE ARE AND CAN AND WILL BE PART
OF THAT.
IT'S IMPORTANT TO HAVE THAT.
IF WE DON'T HAVE SCIENCE AND
MEDICAL, WHAT WOULD WE DO?
>> RIGHT.
>> YOU PROFESSIONALS OUT THERE,
YOU'RE SCRATCHING YOUR HEAD,
HMM, WHAT'S THE NEXT STEP?
AND IT WAS SO BEAUTIFUL WHEN WE
HAD A NEW PRESIDENT THAT CAME
IN, WHAT ARE YOUR QUESTIONS?
HE WAS SO OPEN.
THAT'S THE KIND OF RESPONSE,
TYPE OF RESPONSE TOO, TO SAY,
YES, YOU ARE INCLUDED.
YOU'RE NOT EXCLUDED BUT YOU ARE.
THAT'S HOW I FEEL, IT CAN NEVER
BE LEFT ALONE.
>> EXCELLENT POINT, THAT WHEN
THE PRESIDENT FOR THE NATIONAL
DOWN SYNDROME CONGRESS JOINED,
AS YOU MENTIONED, HE TOOK THE
TIME TO FIGURE OUT WHAT IT IS
THAT -- HOW COULD SELF-ADVOCATES
IN THE COMMUNITY CONTRIBUTE TO
SCIENCE, THAT HE WAS THERE FOR
THEM.
SIMILARLY, I KNOW THAT'S
SOMETHING WE CAN DO IN OUR OWN
CLINICAL RESEARCH ONE LAST
QUESTION, PERHAPS, TONY, FOR
YOU, IS THERE ANYTHING YOU WOULD
LIKE RESEARCHERS TO KNOW OR TO
CONSIDER WHEN PLANNING FOR
FUTURE STUDIES?
>> ME, FOR FUTURE STUDIES,
WILLING AND ABLE TO INTRODUCE IT
MORE, SHARE IT MORE.
THAT TYPE OF PRODUCTIVITY, TO
REENACT THAT.
ALWAYS BE PART OF THAT.
I KNOW ENOUGH TO BE PART OF THE
SECOND WONDERFUL FAMILY OF MINE.
THAT'S HOW I FEEL.
AND I HOPE ALL OF YOU OUT THERE
THAT ARE HEARING ME, I'M A
CANCER SURVIVOR, I WENT THROUGH
EVERYTHING.
I WAS ONLY BORN IN PUERTO RICO,
SAN JUAN, AND I KNEW NOTHING
UNTIL AGE OF MAYBE AT LEAST 5 OR
6.
YOU KNOW NOTHING WHEN YOU'RE
BORN, NO, THAT'S COMPLETELY
NATURAL YOU DON'T REALIZE OR SEE
OR RECOGNIZE OR TO ACKNOWLEDGE.
BUT WHEN YOU GET A LITTLE OLDER
YOU HAVE THAT PURPOSE IN LIFE,
LIKE I'VE MENTIONED, THE
ACKNOWLEDGMENT OF BEING YOURSELF
AND MOST IMPORTANTLY YOU SHARE
IT.
THERE'S TONS OF WORK, SOMEWHERE,
SOMEHOW, WHEREVER, WHENEVER IT
MIGHT TAKE PLACE IN YOUR
SOCIETY, CHILDREN, I STILL HEAR
A LOT OF THINGS THAT CAN WE DO
THIS, CAN WE DO THAT, HOW CAN WE
IMPROVE?
GO BACK TO THE QUESTIONS.
WHERE ARE WE IN LIFE?
WHAT'S OUR PURPOSE?
>> I THINK THAT'S SPOT ON.
IT'S REALLY IMPORTANT BECAUSE IT
NOT ONLY SPEAKS TO WHAT IS OUR
PURPOSE BUT HOW WE'RE ALSO ABLE
TO CONTRIBUTE TO CLINICAL
RESEARCH AND WE KNOW THAT
CONSENTING AND ASSENTING IS A
MAJOR PART OF THAT.
SO, TONY, WE THANK YOU AGAIN FOR
YOUR TIME.
>> JUST ONE MORE THING.
>> ABSOLUTELY.
>> WHILE YOU'RE ON HERE, IF
THERE'S ANY POSSIBLE WAY WITH
YOUR STAFF, A COPY OF THIS, IF
ANYONE OUT THERE WANTS ME TO
SPEAK I'D BE MORE THAN HAPPY TO,
IN YOUR HOMETOWN OR WHATEVER,
HOWEVER.
USE OF FLASH DRIVE, CDs,
HOWEVER YOUR TECHNOLOGY IS OUT
THERE BEING USED, I'M MORE THAN
HAPPY TO.
>> THANK YOU.
WE APPRECIATE THAT.
THAT'S VERY GENEROUS OF YOU TO
OFFER YOUR TIME TO DO THAT FOR
THE COMMUNITY.
>> IF ANYONE HAS EXTRA
QUESTIONS, LET ME KNOW.
>> ABSOLUTELY.
WELL, I KNOW THAT WE HAVE A FEW
QUESTIONS THAT ARE COMING IN,
NOT ONLY FOR YOU, TONY, BUT ALSO
FOR OUR SPEAKERS.
IF WE COULD ASK SHARON, DANNY,
ANN, TO TURN ON VIDEOS, AND
LAURIE AND MYSELF WILL
DEFINITELY BE SURE TO POSE THOSE
TO THE SPEAKERS.
ONE QUESTION OR COMMENT CAME IN
ABOUT SHARING RESULTS OF
RESEARCH AND, LAURIE, I'LL READ
THAT BRIEFLY.
THIS IS FOR THOSE WHO ARE
VIEWING THROUGH VIDEOCAST WHO
MAY NOT BE ABLE TO SEE THE
COMMENTS COMING IN THROUGH THE
CHAT.
SO, SHARING OF RESULTS OF
RESEARCH IS SO IMPORTANT TO
PARTICIPANTS.
IT GIVES MEANING AND
UNDERSTANDING TO THEIR VOLUNTARY
PARTICIPATION.
BUT OFTEN AS BUSY RESEARCHES AND
COORDINATORS WE FORGET THAT
BECAUSE WE'RE ON TO THE NEXT
PROJECT SO I THINK THAT'S A VERY
IMPORTANT POINT TO CONSIDER AND
I KNOW IT WAS MENTIONED BY ALL
THE SPEAKERS, SO MANY THANKS TO
YOU, TONY, FOR SHARING THAT AND
ALSO FOR OUR SPEAKERS.
LAURIE, OVER TO YOU TO ASK THE
FIRST QUESTION.
>> ABSOLUTELY.
FIRST QUESTION IS ACTUALLY FOR
SHARON, WHAT IS THE PROCESS OF
FINDING AN AUTHORIZED RESEARCH
REPRESENTATIVE, ARR, AND HOW
WIDELY UTILIZED AND ACCEPTED IS
THIS PROS FOR INFORMED CONSENT
FOR THOSE WITH IDD.
>> ACTUALLY I DON'T HAVE THE
ANSWER TO THAT QUESTION.
THIS WAS A NEW THING I SAW IN MY
RESEARCH FOR GIVING THIS
PRESENTATION.
SO, I'M GOING TO BE LOOKING MORE
INTO THAT BECAUSE I LIKE THAT
IDEA OF GETTING PEOPLE MORE
INVOLVED IN THE INFORMED CONSENT
PROCESS.
THAT'S NOT SOMETHING THAT WE
HAVE TRIED YET HERE IN NEW YORK
BECAUSE OF SOME STRINGENT IRB
REGULATIONS.
BUT IT'S AN INTERESTING CONCEPT
AND I THINK I WILL EXPLORE IT A
LITTLE BIT MORE.
MAYBE I'LL HAVE THE ANSWER NEXT
TIME WE MEET.
>> THANK YOU, SHARON.
NEXT QUESTION ON THE LIST IS
ACTUALLY FOR DR. COMBS.
WHEN CONSIDERING A WAIVER OF
ASSENT FOR NON-VERBAL
INDIVIDUALS, THIS IS ASSUMING
THE NON-VERBAL IS THE SAME AS
BEING UNABLE TO COMMUNICATE,
MANY PEOPLE WITH DOWN SYNDROME
OR AUTISM WITH OR WITHOUT IDD
ARE CAPABLE OF COMMUNICATION,
THOUGHTS OR IF THERE ARE
ACCOMMODATIONS TO ALLOW FOR
ASSENT FOR THOSE NON-VERBAL?
>> GREAT QUESTION.
I THINK IF YOU'RE ABLE TO USE AN
AAC TO COMMUNICATE, ASSENT IS
RELEVANT.
I THINK MORE IT'S THE LEVEL OF
AN ACTUAL DISABILITY, SEVERE
INTELLECTUAL DISABILITY
PREVENTING COMMUNICATION IS
DIFFERENT THAN SOMEONE WITH
NORMAL INTELLIGENCE WHO HAS
DIFFERENT COMMUNICATION ISSUES,
I THINK IT'S WHAT THE UNDERLYING
CAUSE IS.
I THINK IN GENERAL THE USE OF
AAC OR NOT SHOULDN'T PROHIBIT
YOU FROM GETTING ASSENT FROM
THAT INDIVIDUAL.
>> NEXT QUESTION, ANNIE, NOT TO
SKIP YOU, BUT I HAVE A QUESTION
FOR TONY.
TONY, YOU MENTIONED OR WE
DISCUSSED EARLIER THAT YOU
PARTICIPATE IN THE HUMAN TRISOMY
PROJECT.
WHAT DO YOU TELL YOUR FRIENDS
WITH DOWN SYNDROME WHO ARE
HESITANT TO PARTICIPATE IN
RESEARCH WHO MAY BE AFRAID TO
GET BLOOD DRAWN OR BE INVOLVED?
>> QUITE INTRIGUING, SMALL
WORLD.
I WAS JUST READING THAT FROM
MRS., OR MISS MELISSA, IF THEY
ARE SOMEWHAT HESITANT, GIVE US A
SAMPLE, LIKE BEFORE, AT SOME
POINT.
TALK TO THAT CHILD.
HIM OR HER.
I KNOW THEY MIGHT BE FRANTIC OR
SCARED, AND THIS, NICE TALKING
WITH THAT CHILD, AS YOU GO
ALONG, A SMALL PROCESS.
NOT ALL CHILDREN CAN GO THROUGH
THAT PART, I MEAN, FOR ME I WENT
THROUGH EVERYTHING SO I COULD --
I MEAN, I COULD SEE IT, BUT I
WAS -- THE EXPERIENCE OF MY
LIFE, ONE THING AFTER ANOTHER.
I WAS YOUNG.
I DIDN'T KNOW IT, BUT I KNEW I
WAS TALKING TO PEOPLE AROUND ME,
OF COURSE THAT WAS HOW GOD
WANTED ME TO GO THROUGH ALL
THAT.
LIFE IN THAT SORT OF POSITIVE
RESPONSE.
>> DEFINITELY HAVING THE SUPPORT
OF YOUR FAMILY --
>> OR MAYBE RELATIVES, IF ALL OF
YOUR FAMILY CAN'T BE THERE.
>> EXCELLENT POINT.
THANK YOU.
DR. COHEN, NEXT QUESTION FOR
YOU.
WOULD YOU BE ABLE TO COMMENT ON
THE -- YOU MENTIONED MOVING TO
AN E CONSENT PLATFORM, TO USING
OTHER TOOLS LIKE THE VIDEO OR
e-CONSENT PLATFORMS?
>> YEAH, IT'S NOT CHEAP.
BECAUSE IT'S GOING TO REQUIRE,
YOU KNOW, THERE'S THE
e-CONSENT ITSELF IS NOT A HUGE
COST OR LIFT, IT CAN BE DONE IN
SOME GROUPS -- SOME ARE USING
WEB TAP TO DO e-CONSENTS, BUT
THE VIDEO COMPONENT IS WHERE
THAT CAN BE PROHIBITIVELY
EXPENSIVE.
I THINK ONE THING THAT CAN
HOPEFULLY HAPPEN WITH INCLUDE
AND SOME LARGE STUDIES THAT MANY
OF US ARE A PART OF IS THAT WE
CAN DEVELOP CONTENT FOR SOME OF
THESE PROCEDURES THAT CAN THEN
BE USED BROADLY BY OTHER
RESEARCHERS.
AND SHARED BROADLY.
SO, WHILE IT CAN BE
PROHIBITIVELY EXPENSIVE, MY HOPE
IS THAT AS WE DEVELOP THESE
THINGS THEY CAN BE MADE
AVAILABLE TO THE COMMUNITY.
>> I KNOW THE REALITY IN LIFE
AND THE RESPONSIBILITY, FOR WHAT
SHE SAID, IS A VERY CHANGEABLE
THING IN LIFE.
AND OF COURSE CAN'T FORGET THAT
WHERE YOU ANSWER, WHEN, WHERE,
HOW, CAN YOU DO THAT, THE
RESOURCES, WHERE IS THAT COMING
FROM TOO?
I CAN UNDERSTAND IF YOU'RE IN
THE U.S., THAT'S GREAT.
YOU HAVE THOSE.
BUT LIKE MYSELF, THE COMPLETE
PART OF US FROM NOT JUST BEING
IN THE U.S. WE HAVE OUR ESPAÑOL
CONVENTION.
AND HOW ARE THEY GETTING THOSE
RESOURCES?
SO, IT'S KIND OF LIKE THAT'S AN
IMPASSE, AND SO LIKE WE SAY, I
MEAN, WHERE CAN, HOW CAN, IT
JUST FLOWS.
SINCE I BROUGHT THAT QUESTION
UP, BECAUSE IT'S SO IMPORTANT,
BECAUSE WE WANT TO SHARE THAT.
AND I MENTIONED IT IN THE --
WITH MS. BRITTANY AND OTHERS
LIKE YOURSELF.
IF WE CAN DO SOMETHING WITH OUR
GROUP HERE, AND THE STAFF, WE
CAN FIGURE THAT OUT.
SOME WAY OR ANOTHER.
SO NOW IF ALL OF YOU ARE HEARING
ME, WHAT'S THE BEST WAY?
COULD IT BE BOTH?
THAT COULD BE PART OF YOUR
ANSWER RIGHT THERE.
NOW, I'M IN LOUISIANA.
IT WOULD BE HARD TO HAVE ME
TRAVEL UP, QUESTION MARK, MAYBE
THAT'S SOMETHING FOR YOU ALL,
D.C. STAFF, THAT COULD BE
SOMETHING WE COULD DO TOGETHER
AS A FAMILY GROUP.
SO WE COULD SPREAD THAT TO OUR
BEAUTIFUL GUESTS HERE, THAT ARE
ON HERE.
>> TONY, THAT'S A GREAT POINT.
YOU KNOW, LOOKING AT HOW WE'RE
REACHING UNDERREPRESENTED OR
MINORITIZED GROUPS, AS YOU
MENTIONED, LOOKING AT DIFFERENT
LANGUAGES, AND ALSO BEING
FLEXIBLE, TAKING INTO
CONSIDERATION CULTURAL
COMPONENTS OF EACH OF THOSE
GROUPS IS IMPORTANT, AND PERHAPS
SHARON OR ANNIE OR DAN, WE CAN
ASK YOU, THOSE THINGS THAT, YOU
KNOW, YOU ALL HAVE BEEN ABLE TO
UTILIZE WITHIN YOUR STUDIES.
I KNOW THAT BUILDING OFF OF THE
SEPTEMBER INCLUDE WORKSHIP,
DIVERSITY WORKSHOP, THERE WERE
IMPORTANT LESSONS WITH
MINORITIZED OR UNDERREPRESENTED
GROUPS, ARE THERE THINGS YOU'RE
CONSIDERING WITH REGARD TO
ASSENT AND CONSENT?
>> SO --
>> GO FOR IT, ANNIE.
>> YOU GO FIRST.
>> I THOUGHT ANNIE'S
PRESENTATION WAS SO SPOT ON,
USING EXISTING RELATIONSHIPS.
IN TERMS OF CONSENT, ASSENT IN
PARTICULAR, OBVIOUSLY
TRANSLATION, ALMOST ALL OUR
RESEARCH STAFF SPEAKS SPANISH,
WHICH IS HELPFUL, UNDERSTANDING
THE CULTURAL CONTEXT, WHAT DOES
THIS MEAN.
I SPEAK SPANISH AS A SECOND
LANGUAGE, THERE ARE THINGS THAT
MAKE SENSE TO ME THAT ARE
COMPLETELY WRONG.
ONE THING I TRANSLATESSED, NO,
WHOA, HAVING CULTURAL CONFIDENCE
IN YOUR STAFF MAKES A HUGE
DIFFERENCE.
EVERYTHING ANNIE SAID WAS SO
SPOT ON.
>> I KNOW WHERE YOU'RE COMING
FROM.
ALL MY OTHER SIBLINGS HAVE, IF
GRADUATING FROM THE NAVAL
ACADEMY TO BEING IN A RELIGIOUS
ORDER, THAT WAS MY SIBLINGS,
FOUR OLDER SIBLINGS, TWO OLDER
SISTERS.
THEY HAD TO DO IT.
TO RELIVE AND LIVE THROUGH THEIR
BACKGROUND FOR WHAT THEIR WHOLE
PURPOSES WERE.
SO I CAN UNDERSTAND.
I NEVER HAD THAT CHANCE, I'M
CERTAINLY NOT GOING TO STOP
BY -- HOPEFULLY TO BE A
TRANSLATOR, SO FOR THE NDOC.
SO THAT'S ONE OF MY DREAMS, TO
INTERPRET.
>> AND, ANNIE, I DON'T KNOW IF
YOU HAD ANY OTHER --
>> DAN SAID MUCH OF WHAT I WAS
GOING TO SAY, THAT WE HAVE TO
THINK ABOUT -- WE HAVE TO THINK
ABOUT TRANSLATIONS.
ONE OTHER THING I WANT TO
MENTION THOUGH THAT IS REALLY
IMPORTANT, WHEN WE START
THINKING ABOUT THINGS LIKE
e-CONSENTS AND VIDEOS AND
THINGS THAT WE WANT PEOPLE TO
LOOK AT, AT HOME, WE HAVE TO
THINK ABOUT ACCESSIBLE INTERNET,
AND DEVICES, AND THAT'S
SOMETHING MANY PEOPLE DON'T
HAVE.
AND SO IT DOES BECOME -- YOU
KNOW, THE ACCESSIBILITY PIECE IS
GOING TO ALWAYS BE CHALLENGING
AND SO WE HAVE TO BE FLEXIBLE IN
HOW WE CAN DO THESE THINGS.
AND WHAT SORT OF OPTIONS WE CAN
GIVE FOLKS.
>> WE HAVE ANOTHER QUESTION
THAT'S REALLY A FOLLOW-UP TO
THIS.
FOR ALL OF OUR SPEAKERS.
REFERRING BACK TO THE DIVERSITY
WORKSHOP IT WAS CLEAR THERE WAS
A NEED FOR MORE EDUCATIONAL
SESSIONS FOR PARTICIPATING IN
RESEARCH STUDIES, FOR
HARDER-TO-REACH POPULATIONS I'VE
HEARD USAGE OF MOBILE RESEARCH
UNITS.
HAS THIS BEEN USED IN YOUR
STUDIES TO REACH
UNDERREPRESENTED GROUPS?
>> SO WE HAVE NOT DONE THAT FOR
ABC-DS, WITH THE EXCEPTION OF
SOME OF THE NEUROPSYCH TESTING
WILL BE DONE THROUGH HOME
VISITS.
BUT THIS IS SOMETHING I THINK
THAT'S AN ACTIVE DISCUSSION, HOW
TO GO OUT INTO SOME OF THESE
HARD-TO-REACH COMMUNITIES, AND
BEGIN DEVELOPING THOSE
RELATIONSHIPS.
YOU CAN'T DO PET SCANS OR MRIs
IN THE COMMUNITY BUT WE CAN DO A
LOT OF OTHER STUFF.
SO HOPEFULLY WE'RE MOVING
TOWARDS THAT.
>> SAME FOR US, WE DO A LOT OF
NEUROPSYCH STUFF MOBILE.
SLEEP STUDIES WE DO IN THE LAB,
THOSE ARE IN THE LAB, THE OTHER
THING CAN BE HELPFUL,
CONSOLIDATING THINGS BY PHONE,
DOING THEM BY PHONE.
WE TRY TO MINIMIZE HOW MUCH THEY
HAVE TO COME IN.
SLEEP RESEARCH IS A PLUS BECAUSE
THEY HAVE SOMEWHERE TO STAY,
COMING IN OVERNIGHT ANYWAYS,
THAT TENDS TO HELP.
WHAT'S THE PARTICIPANT BURDEN,
WE CAN WE REMOVE TO MAKE THEIR
LIFE EASIER TO DO THE STUDY.
>> OUR RESEARCH HAS ALWAYS BEEN
VERY MOBILE BASED.
WE USED TO ONLY GO OUT INTO THE
COMMUNITY, INTO GROUP HOMES, OR
DAY PROGRAMS, TO DO THE
NEUROPSYCH, TO DO THE STUDY
PARTNER QUESTIONNAIRES, TO
COLLECT BLOOD.
YOU ASK TRACY AND CINDY, WHO ARE
OUR DATA COLLECTORS, RESEARCH
ASSISTANTS, THEY WILL TELL YOU
THEY PREFER THAT.
IT WAS EASIER TO GO OUT INTO THE
COMMUNITY THAN TO HAVE PEOPLE
COME TO COLUMBIA PRESBYTERIAN
HOSPITAL FOR A VARIETY OF
REASONS.
>> LOOKING AT THE TIME, I WANT
TO SAY THANK YOU TO THE
SPEAKERS, TONY, SHARON, ANNIE,
AND DNA, AS WELL AS TO THE
PARTICIPANTS AND I WOULD BE
REMISS IF WE DID NOT THANK THE
INCLUDE PROJECT COMPONENT 3
PLANNING GROUP FOR THIS.
MANY THANKS FOR YOUR SUPPORT.
THERE'S TOO MANY PEOPLE TO NAME.
IF YOU START NAMING PEOPLE YOU
INEVITABLY WILL MISS SOMEONE.
I WILL JUST SAY THANK YOU TO ALL
NIH STAFF AT INCLUDE.
IF YOU HAVE ADDITIONAL QUESTIONS
AS A FOLLOW-UP, PLEASE REACH OUT
TO SHARON, DAN, AND ANNIE.
THEY HAVE MADE THEIR CONTACT
INFORMATION AVAILABLE.
I KNOW TONY HAS ALSO OFFERED UP
HIS TIME AND IS WILLING TO SPEAK
AND BE AN ADVOCATE FOR RESEARCH,
AS WELL, NOT ONLY FOR OUR
RESEARCH COMMUNITY BUT ALSO TO
OTHER SELF-ADVOCATES.
MANY THANKS AGAIN TO ALL OF OUR
PARTICIPANTS.
LAURIE, OVER TO YOU FOR LAST
COMMENTS.
>> YES, YOU SAID IT ALL.
THANK YOU FOR THIS ABSOLUTELY
WONDERFUL INAUGURAL SESSION.
WE'RE SO GRATEFUL TO OUR SPEAKE.
OUR INCLUDE PROJECT COLLEAGUES,
WE COULDN'T DO IT WITHOUT YOU.
WE'RE PLANNING TO DO, HOPEFULLY,
ONE OF THESE A QUARTER SO THIS
IS OUR FIRST ONE.
STAY TUNED.
WE'LL BE LETTING YOU KNOW AND
WE'LL BE TAPPING SOME OF YOU
AGAIN TO PRESENT.
WE WON'T BOTHER YOU TOO MUCH.
WE PROMISE.
BUT REALLY, THANK YOU SO MUCH.
THIS WAS WONDERFUL.
EVERYONE, HOLIDAYS ARE COMING
UP.
HAPPY THANKSGIVING AND THIS
VIDEOCAST WILL BE AVAILABLE.
IF PEOPLE COULDN'T WATCH IT LET
THEM KNOW THEY CAN VIEW ON
VIDEOCAST.
THANKS, EVERYONE.