>> OKAY.
WELCOME, EVERYONE, TO THE
SECRETARY'S ADVISORY COMMITTEE
ON HUMAN RESEARCH PROTECTIONS ON
MARCH 20, 2024.
MY NAME IS JULIE GOREY, ROLL
CALL.
DR. HOUSE?
>> PRESENT.
>> STATE YOUR AFFILIATION AS
WELL PLEASE.
>> I'M WITH NYU SCHOOL OF
MEDICINE.
>> DR. NEIL DICKERT.
>> EMORY UNIVERSITY SCHOOL OF
MEDICINE.
>> DR. DOUGLAS DIEKEMA.
>> HI, UNIVERSITY OF WASHINGTON,
SEATTLE CHILDREN'S HOSPITAL.
>> DR. SANDRA LEE.
>> GOOD MORNING, AT COLUMBIA
UNIVERSITY.
>> ERIC MAH.
>> UNIVERSITY OF CALIFORNIA SAN
DIEGO.
>> MINDY READER.
>> UNIVERSITY OF ILLINOIS,
COLLEGE OF MEDICINE, PEORIA.
>> LOIS SHEPARD?
>> UNIVERSITY OF VIRGINIA.
>> DR. KEVIN WEINFURT.
>> DUKE UNIVERSITY.
>> DR. YEARBY.
>> THE OHIO STATE UNIVERSITY.
>> THANK YOU.
AND NOW BRUCE LEE, EX OFFICIO
MEMBERS.
>> HOPE IS HERE.
>> CENTER FOR DISEASE CONTROL
AND PREVENTION?
>> MICAH BASS IS HERE.
>> THANK YOU.
FOOD AND DRUG ADMINISTRATION?
>> GOOD MORNING, ANN MEEKER
O'CONNELL.
>> AND KEVIN PARASKA, FDA.
>> HEALTH ADMINISTRATIONS
SERVICE RESOURCE ADMINISTRATION,
KATHY VAN ARDEN.
>> NATIONAL INSTITUTES OF
HEALTH.
>> ADAM BERGER HERE.
>> OFFICE FOR CIVIL RIGHTS?
>> GOOD MORNING, PAYTON ISAAC IS
ON.
>> OFFICE OF NATIONAL
COORDINATOR FOR HEALTH
INFORMATION TECHNOLOGY.
INDIAN HEALTH SERVICE.
OKAY.
THAT IS ALL FROM ME.
AND, DOUG, I'M HAPPY TO TURN IT
OVER TO YOU.
>> THANK YOU, JULIA.
WELCOME, EVERYONE, TO THE SPRING
MEETING OF THE SECRETARY'S
ADVISORY COMMITTEE ON HUMAN
RESEARCH PROTECTIONS.
I AM VERY GRATEFUL TO THOSE WHO
HAVE DONE WORK SINCE OUR LAST
MEETING TO MAKE SURE THIS
MEETING GOES OFF SMOOTHLY AND OF
COURSE THAT IS LARGELY DUE TO
THE EFFORTS OF JULIE GOREY, AND
I'D LIKE TO THANK THE BOTH WORK
THE SUBCOMMITTEES HAVE DONE IN
THE INTERIM TO PREPARE DOCUMENTS
FOR OUR CONSIDERATION TODAY.
AND THIS MEETING IS FAIRLY
FOCUSED.
WE HAVE TWO ITEMS WHICH WE'LL BE
TAKING UP THIS MORNING, FIRST OF
WHICH IS THE INTERPRETATION OF
BEST-INTERESTS STANDARD FOR
RETENTION OF SUBJECTS IN HUMAN
SUBJECTS RESEARCH, THAT HAS BEEN
HALTED OR SUSPENDED, AND THIS
AFTERNOON ETHICAL AND REGULATORY
CONSIDERATIONS FOR INCLUSION OF
LGBTQI+ POPULATIONS IN HHS HUMAN
SUBJECTS RESEARCH.
I'M GOING TO TURN IT OVER TO THE
ACTING DIRECTOR OF OHRP FOR A
FEW WORDS.
>> THANK YOU, DOUG.
WELCOME, EVERYONE.
GREAT TO BE MEETING LIKE THIS
TODAY AGAIN.
ALSO WANT TO ECHO MY THANKS TO
THE SUBCOMMITTEES IN PARTICULAR,
AS DOUG MENTIONED, WHO DO SO
MUCH WORK IN BETWEEN MEETINGS.
WE'RE GRATEFUL FOR ALL THAT YOU
DO TO HELP US PREPARE FOR THESE
LARGER MEETINGS WITH THE FULL
COMMITTEE.
WE DO HAVE ADDITIONAL SACHRP
MEMBERS PENDING APPROVAL AND
HOPE TO HAVE NEWS IN THAT REGARD
SOON BUT DON'T QUITE YET.
SO STAY TUNED.
THAT'S IT FOR ME.
I'LL TURN IT BACK TO YOU.
THANK YOU.
>> THANK YOU, JULIE.
FIRST ITEM WE HAVE BEFORE WE
LAUNCH INTO OUR CORE OF OUR WORK
IS TO APPROVE THE MINUTES FROM
OUR OCTOBER 18 AND 19 MEETING IN
2023.
WERE THERE ANY CHANGES TO THOSE
MINUTES, MEETING MINUTES?
IF NOT, CAN I HAVE A MOTION TO
APPROVE THEM?
>> MOTION TO APPROVE.
>> I'LL SECOND.
>> WE HAVE A MOTION AND SECOND.
ALL IN FAVOR?
WE'LL DO A RAISE OF HANDS.
AND OPPOSED?
AND ANY ABSTENTIONS?
ALL RIGHT.
THOSE MINUTES ARE APPROVED.
OKAY.
AS I MENTIONED BEFORE OUR FIRST
ITEM TODAY IS TO TAKE UP OUR
WORK ON THE INTERPRETATION OF
THE BEST INTEREST STANDARD FOR
RETENTION OF SUBJECTS IN HUMAN
SUBJECTS RESEARCH THAT'S BEEN
HALTED OR SUSPENDED.
AND DAVE BORASKY, CO-CHAIR OF
OUR SUBPART A SUBCOMMITTEE WILL
TAKE US THROUGH THIS.
>> ALL RIGHT.
THANKS, DOUG.
YOURS TRULY BACK AGAIN WITH THIS
DOCUMENT.
HAPPY TO HAVE IT BACK.
IT'S BEEN PRODUCTIVE SEVERAL
MONTHS OF GOING THROUGH
ITERATIONS OF THIS DOCUMENT WITH
THE SUBCOMMITTEE, HAD PRETTY
ACTIVE PARTICIPATION IN THAT
PROCESS, INCLUDING SOME OF THE
SACHRP MEMBERS ON THE CALL
TODAY.
I'M GOING TO GO AHEAD AND SHARE
MY SCREEN WITH THAT DOCUMENT.
FOR ME, THE GOAL TODAY IS TO --
LET ME GO AHEAD AND MAKE THE
GALLERY BIGGER TO LOOK FOR
RAISED HANDS.
MY PERSONAL GOAL IS THAT WE GOAT
A POINT OF APPROVABILITY OF
THESE RECOMMENDATIONS, AND IF WE
CAN'T GET THERE THAT WE LEAVE
THE MEETING WITH SOME CLEAR
UNDERSTANDING OF WHAT ARE THE
LAST OBSTACLES TO GET IT TO
APPROVABILITY IN JULY.
BUT WE'LL SEE WHERE WE GET.
SO, I'VE PULLED UP THE DOCUMENT.
HOPEFULLY EVERYBODY CAN SEE IT.
AND IT IS BIG ENOUGH.
AND WE HAVE SEEN IT A FEW TIMES
NOW AT SACHRP SO I WON'T WALK
THROUGH LINE BY LINE.
I'LL GO SECTION BY SECTION BUT
ENCOURAGE PEOPLE TO STOP ME AND
HAPPY TO BOUNCE AROUND THE
DOCUMENT AS NEEDED.
AGAIN, JUST AS BACKGROUND,
SACHRP ASKED -- OHRP ASKED
SACHRP TO COMMENT ON THE TOPIC
OR IDEA THAT RESEARCH IS
SUSPENDED OR TERMINATED ALL THE
TIME FOR A VARIETY OF REASONS,
AND THAT THE -- THERE MAY BE
TIMES WHERE IT'S IN THE BEST
INTERESTS OF PARTICIPANTS,
EITHER GROUPS OR INDIVIDUALS,
FOR THAT RESEARCH TO CONTINUE.
BUT WE'RE TALKING ABOUT
SOMETHING THAT DOESN'T REALLY
HAVE A FOUNDATION IN THE
REGULATIONS OR REALLY NOT TOO
MUCH EVEN IN EXISTING GUIDANCE
SO INSTITUTIONS AND IRBs AND
EVEN REGULATORS ARE SORT OF LEFT
TO FORGE THEIR OWN PATHS HERE
WHEN DECIDING WHAT'S
APPROPRIATE.
THE HOPE OBVIOUSLY IS THIS
DOCUMENT WILL HELP PUTSOME
BOUNDARIES AROUND THAT OR AT
LEAST GIVE VARYING CONSTITUENTS
IDEAS HOW TO APPROACH THE
PROBLEM WHEN FACED WITH IT.
AND SO A LOT OF WHAT I SAID IS
IN THE BACKGROUND HERE, THIS
IDEA BEST INTEREST ISN'T
DEFINED, NOT REALLY A REGULATORY
ISSUE PER SE.
AND YET WE HAVE THIS PROBLEM
THAT RESEARCH CAN STOP FOR A
NUMBER OF REASONS.
WE'VE GOT FROM LINES 14-26, A
NUMBER OF THOSE REASONS BULLETED
OUT.
IT'S NOT ALL INCLUSIVE BUT IS
REPRESENTATIVE OF COMMON REASONS
RESEARCH ENDS EARLY OR IS
SUSPENDED, RUNNING THE GAMUT,
RESPONSIBLE SONS THAT BECOME
INSOLVENT OR DISAPPEAR OR STOP
FOR A VARIETY OF REASONS.
SIGNALS RELATED TO THINGS LIKE
SUBJECT SAFETY OUT OF A DSMB
MEETING, COMPLIANCE-DRIVEN
ISSUES, WHETHER DRIVEN BY AN IRB
DECISION TO SUSPEND OR HALT A
STUDY OR AN ACTION THAT AFFECTS
AN ENTIRE INSTITUTION THROUGH A
REGULATORY ACTION TO SUSPEND A
FEDERAL-WIDE ASSURANCE.
SO, THERE ARE A VARIETY OF
REASONS WHY RESEARCH CAN STOP.
IT'S BIG AND SMALL, CAN BE VERY
SPECIFIC ISSUE, A VERY BROAD
ISSUE.
IN ANY CASE, THERE WILL BE
PEOPLE THAT ARE NOW LEFT
TRIAL-LESS OR STUDYLESS AND FOR
SOME THERE MAY BE AN INTEREST IN
CONTINUING SOMEHOW TO RECEIVE
THE INTERVENTION OR PARTICIPATE
IN SOME ASPECT OF THE STUDY AND
SO THE QUESTION IS WHAT -- HOW
WE DECIDE IF IT'S REALLY IN
THEIR BEST INTEREST TO DO SO.
SINCE WE LAST TALKED THE
DOCUMENT'S GONE THROUGH MAINLY
REFINEMENTS.
THERE ARE NO HUGE BIG NEW
SECTIONs.
IT WAS A LOT OF ITERATIVE WORK.
THE PLACE WITH THE MOST NEW TEXT
IS AROUND INFORMED CONSENT WHICH
WE'LL GET TO IN A FEW MINUTES.
OTHERWISE, IT REALLY IS MORE OF
A REFINEMENT OF WHAT YOU'VE SEEN
BEFORE.
I'M GOING ASSUME THAT IN GENERAL
THE BACKGROUND SECTION IS PRETTY
CLEAR.
I'LL KEEP WATCHING, I'M WATCHING
FOR HANDS ON THE SCREEN WHEN I
TURN THIS WAY.
DEFINING BEST INTERESTS AGAIN
HAS LARGELY STAYED THE SAME.
AND, YOU KNOW, HERE PART OF IT
IS SORT OF TRYING TO COME UP
WITH THIS IDEA OF WHAT
REPRESENTS A BEST INTEREST, AND
IN DOING SO, YOU KNOW, WE LOOKED
AT A NUMBER OF DOCUMENTS SUCH AS
DECLARATION OF HELSINKI, LOOKED
AT GUIDANCES LIKE FDA GUIDANCE
ON DISRUPTIONS AND ONGOING
RESEARCH TO GET A SENSE OF
WHERE -- EVEN IF A DOCUMENT
WASN'T DIRECTLY ABOUT THIS IDEA
OF BEST INTERESTS, WHERE THEY
SORT OF POINTED PEOPLE IN TERMS
OF DISRUPTIONS AND RESEARCH.
AND WE ACKNOWLEDGE THAT THIS IS
NOT JUST AN ISSUE IN BIOMEDICAL
RESEARCH.
WE THINK OF CLINICAL TRIALS BUT
IT'S NOT LIMITED TO THAT IN ANY
WAY.
AND, YEAH, SO KEVIN?
>> YEAH, THANKS.
JUST A MINOR THING.
LINE 63 THERE, SAYS PERSONS WHO
RESPONDED POSITIVELY TO THE
INTERVENTION.
THAT CONNOTES A CAUSAL EFFECT,
I'M JUST WONDERING WHETHER IT
WOULD BE MORE PRUDENT TO SAY
PERSONS WHOSE HEALTH IMPROVED
WHILE RECEIVING THE INTERVENTION
BECAUSE WE DON'T ACTUALLY KNOW
AT THAT POINT WHETHER THAT
CHANGE IS DUE TO THE
INTERVENTION OR NOT.
>> ANY OBJECTION THERE IS?
>> ONE QUESTION, CHANGE OF
HEALTH, IT COULD BE A CONDITION,
COULD BE A MEASUREMENT.
BROADEN IT, GIVE IT SOME
FLEXIBILITY, I OFFER THAT AS A
--
>> SURE.
>> NOT DISAGREEMENT NECESSARILY
BUT FURTHER CONSIDERATION.
>> YEAH, NO, I THINK THAT'S
WISE.
I'M TRYING TO THINK OF WHAT IS
THE BEST SIMPLE WAY TO DO THAT
EVEN THOUGH THERE MAY BE PERSONS
WHO, YOU KNOW, HAD A --
>> SAY IMPROVED?
>> KEVIN, AM I TOUCHING ON WHAT
YOU'RE CONCERNED ABOUT, MAYBE
THE PERCEPTION OF A POSITIVE
RESPONSE?
IS THAT WHAT YOU'RE GETTING AT?
>> I JUST WANT TO MAKE SURE THAT
WE'RE NOT STATING WE KNOW
SOMETHING WE DON'T KNOW.
>> YEAH.
>> SO WHAT WE KNOW IS THAT
SOMEONE WHO WAS RANDOMIZED TO
INTERVENTION ARM HAS EXPERIENCED
SOME IMPROVEMENT, BUT TO USE THE
WORD "RESPONDED" SOUNDS LIKE
WE'RE DESCRIBING A SITUATION
WHERE WE KNOW THAT THIS PERSON
IS GETTING IMPROVED BECAUSE OF
THE DRUG WHICH SEEMS LIKE THAT
WOULD CHANGE THE CONSIDERATION
OF HOW WE THINK ABOUT THE
SITUATION.
SO I WANT TO BE SURE ABOUT WHAT
WE KNOW.
>> SO WHAT I'VE DONE IS I'VE
GOTTEN RID OF RESPONDED
POSITIVELY AND SAYS PERSONS WHO
BELIEVE INTERVENTION, I COULD
SAY BENEFITED FROM PARTICIPATION
IN THE RESEARCH OR FROM THE
STUDY.
>> THAT'S FINE WITH ME.
>> YEAH, I THINK THAT'S EVEN
BETTER.
>> YEP, YEP.
>> OKAY.
ALLISON AND THEN LOIS?
ALLISON?
>> JUST TO BEAT THAT HORSE A
LITTLE BIT FURTHER, YOU KNOW, WE
TYPICALLY DON'T ALLOW JUST
PARTICIPANT TO SAY I THINK IT
HELPED ME AND LET THAT BE THE
BAR.
WE REQUIRE THAT THE PARTICIPANTS
INVOLVED CLINICIAN AGREE THERE
WAS BENEFITS.
>> SO IS THERE A NEAT WAY TO
NEST THAT IN?
>> EVEN THOUGH THERE MAY BE
PERSONS WHO -- CHOOSE HEALTH
CARE -- WHOSE HEALTH CARE
PROVIDERS BELIEVE THEY BENEFITED
FROM.
>> .
>> SORRY.
CLARIFICATION, I'M NOT FOLLOWING
WHAT YOU'RE SAYING.
>> WE DON'T LET ALLISON SAY,
HEY, I IMPROVED, AND GO, OKAY,
ALLISON HAD THE DRUG.
WE HAVE ALLISON'S DOCTOR SAY,
YES, I AGREED THAT ALLISON
IMPROVED AND SO SO WE WILL
CONSIDER ALLISON'S REQUEST TO
CONTINUE ON THE DRUG.
IF THERE'S A DIFFERENCE OF
OPINION, IF ALLISON SAYS, I GOT
BETTER, ALLISON'S DOCTOR SAYS,
LOOK, I DON'T AGREE WITH THAT,
IT'S ALLISON'S DOCTOR'S OPINION
WHO IS GOING TO CARRY THE DAY,
NOT MINE.
>> SO THERE'S A WHOLE BUNCH OF
OTHER HANDS THAT POPPED UP.
I DON'T KNOW IF THIS HELPS, BUT
I ADDED THIS COMMENT ABOUT
HEALTH CARE PROVIDERS SORT OF
AGREEING WITH THEIR I'LL CALL IT
SUBJECTIVE BELIEF THEY
BENEFITED.
I DON'T KNOW IF WE WANT TO SAY
THEY HAVE TO PROVE THEY
BENEFITED BUT, YOU KNOW, OFTEN
IT IS SORT OF A BELIEF THAT THEY
DID.
AND EVEN THOUGH THE SECOND --
LAST TWO LINES OF THE SECTION
TALK ABOUT STUDY DRUG, WE MADE A
POINT BEFORE ABOUT TALKING ABOUT
THAT THIS ISN'T JUST FOR
BIOLOGICAL THINGS SO I ALSO
DON'T KNOW IF THE END OF THIS
NEEDS TO BE -- YOU KNOW, NEEDS
TO BE TWEAKED TO TALK ABOUT A
STUDY MORE BROADLY AND HAVE AN
EXAMPLE OF IT, YOU KNOW, THERE
ARE CIRCUMSTANCES SUCH AS
INVESTIGATIONAL PRODUCT, NO
LONGER AVAILABLE.
>> RIGHT.
THAT'S WHERE I WAS GETTING HUNG
UP A LITTLE BIT.
JUST THAT IT'S SUCH A VARIETY OF
CIRCUMSTANCES.
>> LOIS, WAS YOUR HAND RAISED TO
THIS POINT?
>> WELL, IT WAS A COUPLE THINGS.
I WONDER IF WE MIGHT SAY EVEN
THOUGH THERE MAY BE PERSONS
WHOSE BELIEVE AND WHOSE HEALTH
CARE PROVIDERS AGREE THAT THEY
MAY HAVE BENEFITED.
THAT MAKES IT EVEN --
>> RIGHT.
>> NOT PUTTING THE CAUSAL IN
THERE.
YOU'RE MISSING AT THE BEGINNING
OF THE SENTENCE, IT IS
INEVITABLE THERE WILL BE, SO
YOU'RE MISSING A WORD THERE.
AND THEN I JUST WONDERED DID WE
NEED THE PARENTHETICAL AT THE
END OF THE SENTENCE?
IT JUST GOT HARD TO READ AND I
DON'T KNOW IF IT REALLY ADDS
ANYTHING TO THIS AS AN EXAMPLE
OF THE KINDS OF THINGS.
SEEMS LIKE IT'S GOING TO ANOTHER
TOPIC TO ME.
IT'S NOT A BIG DEAL.
I'M NOT OPPOSED TO IT.
IT JUST MADE THAT HARD TO
UNDERSTAND WHAT THE MAIN POINT
--
>> IF WE GOT RID OF THAT, LET ME
CHANGE THIS TO INTERVENTION, NOT
JUST LIMITED TO DRUG STUDIES, SO
THAT ACTUALLY HELPS ME MAKE
SENSE OF IT ALL.
I DON'T KNOW HOW OTHERS FEEL.
NEIL?
>> I HAVE TWO QUESTIONS ABOUT
THE PARAGRAPH THAT I MEANING
MIGHT BE HELPFUL FOR SOME OF
THIS DISCUSSION.
SO MOST CONCRETELY, I THINK
WE'RE TALKING ABOUT SITUATIONS
WHERE ISSUES ARE CONSIDERED AND
NOT CRITERIA FOR WHICH THEY ARE
DETERMINATIVE.
SOME OF THE LANGUAGE WE'RE
TALKING ABOUT IS WHEN WE THINK
IT SHOULD TRIGGER DOING THIS, IN
REALITY THE PARAGRAPH IS
INTENDED TO BE AN INTRODUCTION
OF TIMES WHERE YOU MIGHT THINK
ABOUT IT.
AND I THINK --
>> CORRECT.
>> I THINK THAT'S IMPORTANT TO
REMEMBER WHEN WE'RE TRYING TO
REFINE THE LANGUAGE.
SECOND PIECE IS ONE THAT IT MAY
BE CLEAR, THE PARAGRAPH STARTS
WITH DISCUSSION OF PSYCHOLOGICAL
BENEFIT, I HAD A HARD TIME
TELLING WHETHER THE PARAGRAPH IS
ABOUT MULTIPLE TYPES OF BENEFITS
OR THIS IS A SUBSET OF
PSYCHOLOGICAL BENEFIT.
AND SO IF WE'RE TALKING ABOUT
MULTIPLE TYPES OF BENEFITS THIS
MAY SOUND PICKY BUT MIGHT BE
HELP FOLLOW HAVE OPENING
SENTENCE BE MULTIPLE TIMES OF
BENEFITS THAT MIGHT GET
TRIGGERED, ONE PSYCHOLOGICAL,
THE OTHER PEOPLE BELIEVE THEY
MAY HAVE BENEFITED, MAY NOT BE
PSYCHOLOGICAL, I WANT TO MAKE
SURE WE DON'T -- THE LAST
SECTION, AS I READ IT, NOT
INTENDED TO BE ABOUT
PSYCHOLOGICAL BENEFIT.
THERE'S A STATE WHERE PEOPLE
BELIEVE THEY BENEFITED FOR
POTENTIALLY A NUMBER OF REASONS.
IT'S A MINOR EDIT BUT MIGHT HELP
THE PARAGRAPH TO BE CLEARER IN
TERMS OF WHAT WE'RE INTENDING
THE SCOPE TO BE.
>> SO IS YOUR SUGGESTION -- IF
I'M HEARING YOU CORRECTLY, I
THINK I AM, IS THE SIMPLE ANSWER
THEN TO DELETE THAT FIRST
SENTENCE?
>> NOT IF WE THINK THAT'S ONE OF
THE TYPES OF BENEFITS.
I WOULD ADD A FIRST SENTENCE,
THERE'S A NUMBER OF TYPES OF
BENEFITS THAT MIGHT TRIGGER
CONSIDERATION OF THIS.
ONE WOULD BE PSYCHOLOGICAL
BENEFITS IN DETERMINING BEST
INTERESTS, TALK ABOUT THE
PLACEBO PIECE.
SECOND IT'S INEVITABLE THERE ARE
SITUATIONS WHERE WE FIND THAT
THE STUDY WAS STOPPED BECAUSE IT
DIDN'T LOOK HELPFUL BUT THERE
ARE PEOPLE WHO GOT BETTER AND WE
NEED TO -- THAT'S NOT
NECESSARILY A PSYCHOLOGICAL
STATE.
>> RIGHT.
>> THIS IS WHAT GETS THIS ON THE
TABLE RATHER THAN BEING WHAT THE
CRITERIA FOR SUFFICIENCY OF
DETERMINING BEST INTERESTS ARE
ADVANCED BY CONTINUING.
DURING PARTICIPATION RESEARCH
THAT MIGHT TRIGGER BEST INTEREST
CONSIDERATIONS OR SOMETHING LIKE
THAT.
>> OKAY.
OTHER SUGGESTIONS OR CHANGES
BEFORE I SCROLL DOWN?
I'LL LEAVE IT UP FOR A SECOND.
MINDY?
>> I WAS WONDERING, IN THAT
SENTENCE AT 64, WHERE IT SAYS
PERSONS WHO BELIEVE, COULD YOU
JUST SAY EVEN THOUGH THERE MAY
BE PERCEIVED BENEFIT?
FROM THE STUDY?
EVEN SAYING HEALTH CARE
PROVIDERS, I MEAN, ARE ALL
STUDIES INVOLVING HEALTH CARE
PROVIDERS THAT MIGHT BE STOPPED?
I MEAN -- I'M JUST NOT SURE.
>> YEAH.
IT'S A PRETTY LONG LAST
SENTENCE.
MY ONLY CONCERN CHANGING IT THAT
WAY THIS LAST SENTENCE WAS AN
EXAMPLE OF STUDIES THAT ARE
STOPPED DUE TO NEGATIVE OVERALL
RESULTS.
I'M SEEING IF IT WORKS TO CHOP
THAT DOWN TO --
>> EVEN THOUGH THERE MAY BE
PERCEIVED BENEFITS.
THEN THAT COULD BE FROM THE
SUBJECT, FROM THEIR PROVIDER,
ALL THOSE THINGS.
>> RIGHT.
THAT WOULD -- WOULD YOU END THE
SENTENCE THERE?
>> EVEN THOUGH THERE MAY BE
PERCEIVED BENEFIT, WHERE IS IT?
FROM THE INTERVENTION?
EVEN THOUGH THERE MAY BE
PERCEIVED BENEFIT FROM THE
INTERVENTION RECEIVED DURING THE
STUDY OR SOMETHING LIKE THAT.
>> MAY BE PERCEIVED BENEFITS,
BENEFIT --
>> FROM THE STUDY'S INTERVENTION
OR FROM THE INTERVENTION PERIOD.
>> STUDY/INTERVENTION, YEAH.
>> ALTHOUGH I DID LIKE THE IDEA
KEEPING THAT PART ABOUT THE IDEA
THAT PERSONS MIGHT WANT TO
CONTINUE, RIGHT?
I WONDER IF WE COULD SAY EVEN
THOUGH THERE MAY BE PERCEIVED
BENEFIT TO PERSON WHO WANT TO
CONTINUE, YOU KNOW, PERCEIVED
BENEFIT FROM THE STUDY TO
PERSONS WHO WANT TO CONTINUE ON
THE INTERVENTION.
I THOUGHT THAT WAS AN IMPORTANT
PART OF WHAT THE THING -- WHAT
THE PARAGRAPH WAS SAYING.
SOME PEOPLE WANT TO CONTINUE.
IF WE LOSE THAT --
>> YEAH, SO IF I DID THAT --
TRACKING MAKES IT MESSY.
THAT'S WHAT IT WOULD LOOK LIKE
CHOPPED DOWN SO I DON'T KNOW IF
THAT SORT OF PRESERVES WHAT YOU
WERE CONCERNED ABOUT, LOIS.
THAT ADDRESSES MINDY'S CONCERN.
>> I'M HAPPY WITH THAT.
>> ALL RIGHT.
WELL, LET ME SCROLL THEN.
I THINK WE'RE GOING TO HAVE TIME
IF WE WANT TO COME BACK TO THIS
PIECE, EITHER IN THIS SECTION OR
EVEN LATER TODAY WE CAN.
I'M NOT SEEING ANY OTHER
OBJECTIONS TO IT.
THESE OTHER TWO PARAGRAPHS
REALLY AREN'T ALL THAT DIFFERENT
THAN THEY HAVE BEEN ALL ALONG,
SO KEVIN?
>> I PROMISE I WON'T HAVE A LOT
OF COMMENTS ON THIS DOCUMENT.
>> IT'S
>> 75, WHEN I READ IT, THIS,
THIS IS AN EXPRESSION, IT SOUNDS
LIKE THAT'S REFERRING TO WHEN A
PROVIDER HAS PUT HIS OR HER OWN
INTERESTS ABOVE THE INTEREST OF
THE PATIENT, WHICH I DON'T THINK
IS INTENDED.
SO MAYBE THIS EXPRESSES A
CONCERN ABOUT THE FIDUCIARY DUTY
OR SOMETHING LIKE THAT.
>> OKAY.
THAT'S HOW THAT WOULD LOOK
FOLLOWING YOUR SUGGESTION, WHICH
IS FINE WITH ME.
LOIS?
>> I HAVE A LITTLE THING IN THE
LAST SENTENCE OF THE PARAGRAPH.
HOWEVER THEY.
THE "THEY" WAS REFERRING BACK
TOO MANY SENTENCES BEFORE FOR
ME.
SO WE MIGHT SAY --
>> RESEARCHERS?
>> RESEARCHERS OR INVESTIGATORS,
EITHER ONE.
>> OKAY.
ARE WE OKAY WITH THAT?
NOT SEEING ANY OBJECTIONS, I'LL
SCROLL DOWN TO OUR ANALYSIS
SECTION.
AND, AGAIN, OVER THE LAST FEW
MONTHS, A LOT OF TAILORING TO
THIS, BUT I DON'T KNOW THAT
THERE'S BEEN REALLY SIGNIFICANT
CHANGES SINCE YOU LAST SAW IT.
AGAIN, SOME FACTORS THAT SHOULD
BE CONSIDERED, MAKING BEST
INTEREST, AS IS OFTEN THE CASE
IN THESE DOCUMENTS.
WE'RE SORT OF WALKING A FINE
LINE, DON'T WANT PEOPLE TO THINK
THESE ARE THE ONLY ONES OR THAT
THIS IS ALL INCLUSIVE LIST, BUT
THESE WERE THE EXAMPLES THAT
THE -- BOTH PREVIOUS THIS
COMMITTEE AND THE SUBCOMMITTEE'S
THOUGHT WAS A REASONABLE LIST TO
PUT IN THE DOCUMENT.
KEVIN?
>> SORRY, A TINY THING.
106, WE SAY EARLIER IN 74 AND
75, IT IS DEBATED, SOMEONE MIGHT
READ IF THERE'S A FIDUCIARY DUTY
AS A LOGICAL STATEMENT, NOT IF
YOU BELIEVE THAT.
SHOULD WE SAY IF IT'S DETERMINED
THERE IS A FIDUCIARY DUTY OR
SOMETHING LIKE THAT, JUST TO
KEEP IT CLEAR THAT THAT IS STILL
SOMETHING THAT'S DEBATED.
>> OKAY.
>> THANKS.
>> DAVE, TALKING ABOUT FIDUCIARY
DUTY I DON'T REMEMBER THIS PART.
I'M SORRY.
>> GO AHEAD, ERIC.
YOU GOT THE FLOOR.
>> THANKS.
I JUST DON'T REMEMBER, I'M
TRYING TO ENVISION A FIDUCIARY
DUTY BY RESEARCHERS.
CAN YOU EXPRESS WHAT THE
SUBCOMMITTEE WAS THINKING ABOUT
THIS?
I CAN'T -- A LITTLE UNUSUAL FOR
ME, TO THINK OF FIDUCIARY DUTY
FOR RESEARCHER.
>> OFF THE TOP OF MY HEAD, NO.
WE HAVEN'T TALKED ABOUT THIS,
THIS PART OF THIS SECTION IN A
WHILE.
>> OKAY.
I'LL NOODLE ON IT.
I'M A LITTLE CONCERNED ABOUT IT.
IT DOESN'T POP OUT TO ME WHAT
THIS MEANS.
>> WE CAN THINK ABOUT THAT.
ALLISON?
>> A SCENARIO THAT KEPT COMING
TO MY MIND, THAT I THOUGHT IT
SHOULD PERHAPS BE CALLED OUT.
IT'S THE SITUATION IN WHICH --
WELL, IT SEEMS LIKE WE'RE
TALKING A LOT ABOUT RESEARCH
SCENARIOS IN WHICH AN
INTERVENTION MOST LIKELY A DRUG
IS BEING PROVIDED TO THE
PATIENT, AND WHEN THE RESEARCH
IS RESUMED WE'RE RESUMING GIVING
THAT DRUG BACK TO THE PATIENT OR
OTHER PATIENTS.
BUT I CAN VERY EASILY FORESEE A
SITUATION IN WHICH RATHER THAN
GETTING A DRUG AFTER RESUMPTION
OF RESEARCH, WHAT IS BEING
RESUMED FOR AT LEAST A NUMBER OF
PATIENTS IS JUST FOLLOW-UP
MONITORING BECAUSE THE
MONITORING, THE FUNDING FOR THAT
IS BUILT INTO RESEARCH PROTOCOL.
PEOPLE AREN'T NECESSARILY
GETTING DOSED OR REDOSED OR
WHATEVER ELSE BUT THEY ARE BEING
TRACKED AND FOLLOWED.
I DON'T REALLY SEE THAT BEING
CALLED OUT AS A SCENARIO.
AND I THINK THAT THAT'S ONE THAT
I THINK HAS, YOU KNOW, A VERY
SORT OF DIFFERENT CALCULUS.
>> SO, I PRESUME YOU'RE TALKING
ABOUT THE BULLETED LIST.
>> YES.
>> COULD ONE BE ADDED THAT SAYS,
YOU KNOW, THAT A FACTOR THAT MAY
BE CONSIDERED IS THE NEED FOR
THE ONGOING COLLECTION OF SAFETY
DATA?
>> SAFETY DATA OR, YOU KNOW,
JUST PATIENT MONITORING.
I MEAN NOT PATIENT MONITORING,
PARTICIPANT MONITORING.
YES, THANK YOU, DAVE.
SUBJECT MONITORING.
>> LOIS?
>> I WANTED TO SPEAK TO THAT
PARAGRAPH THAT BEGINS ON 107
NOW.
>> UH-HUH.
>> BECAUSE THIS IS -- I STUMBLED
ON THIS TOO BECAUSE I DON'T
THINK WE NEED TO GET INTO THE
DEBATE REALLY ABOUT WHETHER OR
NOT RESEARCHERS, PHYSICIANS IN
PARTICULAR, RESEARCHERS WHO
ENROLL THEIR OWN PATIENTS IN
THEIR RESEARCH OWE A FIDUCIARY
DUTY OR IF THE FIDUCIARY DUTY
THAT'S BEEN ALTERED BY THE
INFORMED CONSENT PROCESS, AND
GETTING CONSENT, I WONDER IF WE
MIGHT JUST LEAVE IT MORE -- I
LIKE THE DISCUSSION OF FIDUCIARY
DUTY ABOVE WHICH IS JUST TALKING
ABOUT DIFFERENT WAYS OF
UNDERSTANDING BEST INTERESTS,
BUT MAYBE WE SHOULD JUST -- THE
POINT IT SEEMS TO BE IS IN SOME
CIRCUMSTANCES, LEAVING A BLANK
FOR WHAT THAT IS, BUT IN SOME
CIRCUMSTANCES, YOU KNOW, THERE
MAY BE AN OBLIGATION TO
TRANSITION PATIENT SUBJECTS INTO
OTHER CLINICAL CARE.
AND SO, YOU KNOW, ESPECIALLY
BECAUSE IT'S A RESEARCHER
PHYSICIAN, IF IT IS, SO I'M
WONDERING IF WE CAN LEAVE IT
VAGUE, IN SOME INSTANCES THERE
MAY BE PROFESSIONAL OR, YOU
KNOW, THERE -- I DON'T KNOW HOW
TO SAY IT BUT NOT FOCUSING IT ON
THIS, IF IT IS DETERMINED,
BECAUSE THERE MIGHT BE AN
OBLIGATION TO DO THIS EVEN IF
THERE'S NOT A FIDUCIARY DUTY BUT
A SPECIAL RELATIONSHIP OR -- YOU
KNOW, LEGALLY IT CAN GO A NUMBER
OF WAYS.
MAYBE THE BEST THING IS NOT TO
GET INTO THAT DEBATE BUT JUST
ACKNOWLEDGE THAT IN SOME
CIRCUMSTANCES, YOU KNOW, THERE
MAY BE AN OBLIGATION BUT I DON'T
KNOW IF THAT'S SAYING THAT TOO
STRONGLY BECAUSE WE'RE NOT
SAYING WHEN IT IS BUT WE'RE
ACKNOWLEDGING THAT SOMETIMES
THERE MAY BE.
>> YEAH, SO I'M CURIOUS, YOU
KNOW, I THINK THE FIRST HALF OF
IT CAN BE NARROWED DOWN OR
SHIFTED AWAY FROM THE FIDUCIARY
DUTY ASPECT TO SIMPLY NOTE THAT
THERE CAN BE CIRCUMSTANCES WHERE
THE NEEDS FOR THE SUBJECT'S
CLINICAL CARE SORT OF CREATE
THAT THERE'S AN -- THAT
RESEARCHERS HAVE A -- MAY HAVE
AN OBLIGATION OR PROFESSIONAL
ETHICAL, WHATEVER OBLIGATION TO
ENSURE THE TRANSITION OF
SUBJECTS FROM THEIR STATUS AS
SUBJECT BACK INTO APPROPRIATE
CLINICAL CARE.
IT'S MESSY, AND IT'S COMING
TOGETHER IN MY HEAD BUT WOULD
SORT OF PUSH OFF THIS FIDUCIARY
DUTY THING AND FOCUS ON THAT
PIECE.
ERIC, I DON'T KNOW IF THAT WOULD
HELP.
>> I'M WONDERING IF IT'S
REDUNDANT POSSIBLY.
>> IT MAY BE.
>> YOU TALK ABOUT THAT IN 103 TO
106.
IF YOU LOOK AT 103 AND 106 AND
COMPARE TO 107 AND 110, TO ME
THEY ARE VERY SIMILAR.
>> YEAH.
>> I'LL LEAVE IT TO YOU.
I DON'T THINK WE NEED IT
NECESSARILY IS WHERE I'M
LANDING.
I THINK IT'S COVERED IN 103 TO
106, OTHER PARTS WE GO INTO
THIS.
THE FIDUCIARY WORD IS TRIGGERING
FOR ME, MAYBE WE WANT TO TAKE IT
OUT.
>> AS YOU SAY THAT, ERIC,
PARTICULARLY -- THAT PART C OF
THAT SECTION YOU WERE QUOTING, I
MEAN IT DOES -- MANAGEMENT --
I'M HAPPY TO LEAVE THAT AND
STRIKE THAT LAST PARAGRAPH IF
THAT'S NOT PROBLEMATIC FOR LOIS
OR OTHERS.
>> I THINK THAT WOULD BE MY
INCLINATION.
ALWAYS BETTER TO TRIM OUR
DOCUMENTS WHENEVER POSSIBLE.
>> SANDRA?
>> IF I COULD ADD TO THAT, YOU
KNOW, THE SECTION FROM 103 TO
106 FOCUSES ON THE SUBJECT.
BUT I THINK WHAT 107 DOES, IT
STARTS TO INTRODUCE THE
RELATIONSHIP BETWEEN RESEARCHERS
AND SUBJECTS AND WHATEVER
ETHICAL OBLIGATIONS THERE ARE TO
CARE, TO CONTINUE CARE FOR THE
SUBJECT BECAUSE OF THAT
RELATIONSHIP.
AND I GUESS I WOULD LOVE TO
LEARN MORE FROM YOUR DISCUSSIONS
WITH THE SUBCOMMITTEE IF THAT
WAS SOMETHING THAT WAS IMPORTANT
TO INCLUDE.
I DO THINK THE LANGUAGE AROUND
FIDUCIARY DUTY RAISES MORE
QUESTIONS AND DOES NEED TO BE
EXPLAINED IF IT'S LEFT IN.
BUT I DO THINK THERE'S SOMETHING
LOST IF YOU WOULD TAKE OUT THAT
WHOLE SECTION IN TERMS OF
OBLIGATIONS WITH RESPECT TO THE
RELATIONSHIP, WITH RESEARCHERS.
>> YEAH.
AS I SAID, IT'S BEEN A WHILE
SINCE THE SUBCOMMITTEE I THINK
TALKED ABOUT THIS PART OF THIS
SECTION.
I THINK THAT IF THE FIRST HALF
OF THAT FIRST SENTENCE AT 107 IS
WHAT IS CREATING CONFUSION MY
BEST MEMORY OF WHAT THE
SUBCOMMITTEE WAS COMING DOWN
WITH THIS PART OF IT WAS, YOU
KNOW, MAKING IT CLEAR THAT THERE
IS SOME SORT OF EXPECTATION,
OBLIGATION, AGAIN WHETHER IT'S
PROFESSIONAL OR WHETHER IT'S
ETHICAL OR HAS MULTIPLE FACETS
WHERE THE RESEARCHERS OR
INVESTIGATORS OWE IT TO THEIR
SUBJECTS TO -- IF THE STUDY
SENDING TO MAKE SURE THEY ARE
APPROPRIATELY TRANSITIONED TO
WHATEVER POST-RESEARCH CARE IS
NECESSARY TO ENSURE THEIR
WELL-BEING.
>> UH-HUH.
>> NOW, WHETHER THAT CREATES
PROBLEMS LATER WHEN WE TALK
ABOUT LIMITS, YOU KNOW, WELL WE
CAN GET TO THAT LATER.
TO ME THAT'S AT THE CORE OF
THIS, WAS BASICALLY NOT SAYING,
WELL, RESEARCH IS DONE, TO FIND
YOUR WAY BACK TO THE HEALTH CARE
SYSTEM.
>> IF THAT'S THE CASE, IF THERE
NEEDS TO BE A STATEMENT RATHER
THAN THE WAY IN WHICH THIS IS
SET UP NOW.
IT'S ALMOST AS IF THERE'S A TEST
THAT NEEDS TO BE MET BECAUSE IF
IT IS DETERMINED THAT THERE'S A
FIDUCIARY DUTY IT SEEMS LIKE
WE'RE ADJUDICATING SOMETHING
DIFFERENT THAT NEEDS TO BE
EXPLAINED NOW.
ANYWAY, THAT'S -- IF THAT'S THE
THINKING FOR THIS SUBCOMMITTEE.
I'M WORRIED ABOUT -- I GUESS I
WOULD STRIKE THE FIDUCIARY DUTY
HERE AND LEAVE IT MORE GENERAL
THAN SPECIFIC BECAUSE I THINK
THAT THAT ACTUALLY INTRODUCES A
WHOLE HOST OF QUESTIONS.
>> LOIS?
>> YES, I AGREE WITH SANDRA
THERE.
THAT THERE'S SOMETHING IMPORTANT
IN THIS PARAGRAPH THAT'S
DIFFERENT FROM I THINK WHAT'S
ABOVE.
NOW, I HAVEN'T LOOKED AT THE
WHOLE DOCUMENT AGAIN IN THE
CONTEXT OF THIS CONVERSATION SO
IT MIGHT BE COVERED ELSEWHERE.
BUT IN 103 AND 104 IT'S TALKING
ABOUT CONTINUATION MAY BE
APPROPRIATE AND I THINK THERE'S
A STATEMENT EARLY OTHER IN THE
DOCUMENT ABOUT WHEN WE'RE SAYING
IT MAY BE APPROPRIATE WE'RE NOT
SAYING THAT IT'S REQUIRED.
AND SO THAT WORD, APPROPRIATE,
IN 104 IS DOING SOME WORK BUT
NOT GOING TO COVER THE IDEA
THERE MAY BE OBLIGATIONS TO
TRANSITION, YOU KNOW, INTO
MEDICAL CARE.
SO ANYWAY, I THOUGHT YOUR
SOLUTION WAS A GOOD ONE.
>> OKAY.
>> I COULD ALSO BE IN FAVOR OF
KEEPING SOME WAY OF SAYING THIS.
>> OKAY.
>> THAT'S IN THAT PARAGRAPH.
>> I THINK I CAN DO THAT.
I'LL I WON'T TRY TO FIGURE THAT
RIGHT NOW BUT I'VE GOT A NOTE TO
MYSELF THIS MAY BE SOMETHING TO
COME BACK TO AT THE BREAK AND
PUT SOMETHING, LOOK LATER IN THE
AGENDA.
OKAY.
I'LL GO TO ADDITIONAL
CONSIDERATION SECTION.
HERE SOME OF THIS, SOME OF THE
PRACTICAL MEASURES IN THE FIRST
PARAGRAPH TALKING ABOUT THE FACT
THAT, YOU KNOW, ON ONE END YOU
CAN SAY BEST INTEREST BUT OTHER
THINGS MAY NEED TO BE MANAGED,
INTERVENTION TO RESUME, ACCESS
TO INTERVENTION TO RESUME.
FOR EXAMPLE LEGAL, CONTRACTUAL,
FINANCIAL BARRIERS.
AND IN A WAY DIFFERENT THAN WHAT
ALLISON WAS TALKING ABOUT, THE
END OF LINE 114 INTO 115 THIS
WOULD HAVE TO BE RESOURCED
OBVIOUSLY TO ALLOW IT TO GO
FORWARD.
116 IS INVESTIGATOR LEVEL
COMPLIANCE ISSUES, WHEN THOSE
THINGS HAPPEN THERE WILL BE A
DISCUSSION WHAT'S APPROPRIATE TO
RESUME.
AND THEN THIS GOES BACK A WHILE
SINCE THE FIRST TIME THAT YOU
ALL LOOKED AT THIS DOCUMENT, THE
OTHER REALITY IS MENTIONED AT
THE BEGINNING OF THE DOCUMENT,
THAT THERE'S ALSO SITUATIONS
WHERE RESEARCHERS SUSPENDED OR
TERMINATED AT INSTITUTIONAL
LEVEL SUCH AS SUSPENSION OF
FEDERAL-WIDE ASSURANCE THAT
AFFECTS ALL RESEARCH UNDER A
FEDERAL-WIDE ASSURANCE EVEN WHEN
THERE'S BEEN NO PARTICULAR
ISSUES OR PROBLEMS WITH
INDIVIDUAL STUDIES THAT ARE
UNDER THAT FWA, AND HERE IT
DOESN'T GIVE THE SILVER BULLET
SOLUTION BUT NOTES THIS IS A
CASE WHERE CONSIDERATION HAS TO
BE GIVEN TO RESUMPTION OF
RESEARCH AND BEST INTEREST CAN
BE PART OF THAT DISCUSSION.
127 PARAGRAPH IS DIFFERENT THAN
WHAT I'LL CALL A FOR-CAUSE
SUSPENSION BUT DOES HAPPEN WHERE
INVESTIGATORS OR RESEARCH TEAMS
OR RESEARCH THROUGH INSTITUTIONS
DECIDE THEY NO LONGER WANT TO BE
INVOLVED IN THE RESEARCH, AND
WHAT HAS HAPPENED IN THOSE
CASES, AND THEN 133 PARAGRAPH,
THIS HAS TO DO WITH A LACK OF
FUNDING.
IT CAN AND DOES HAPPEN THAT
SPONSORS PARTICULARLY, YOU KNOW,
SOMETIMES IN THE CASES OF SMALL
BIOTECH THEY RUN OUT OF MONEY.
AND THAT BECOMES A LITTLE
TRICKIER BECAUSE, YOU KNOW, IT
SAYS IRBs DON'T HAVE AUTHORITY
TO COMPEL A SPONSOR TO CONTINUE
A TRIAL, BEST INTERESTS,
PATIENTS' OR PARTICIPANTS AS
BEST INTEREST IN THE RESEARCH,
BUT THERE'S -- THAT CAN BE A
PROBLEMATIC SCENARIO.
AND THEN FINALLY THIS LAST
PARAGRAPH AT 142 TALKS ABOUT
EXPANDED ACCESS.
AGAIN THIS DOCUMENT ISN'T ABOUT
EXPANDED ACCESS.
WE ENDED UP ADDING A FOOTNOTE
HERE TO DESCRIBE THIS AS A
PATHWAY.
WE TRIED TO EMBED IT INTO THE
DOCUMENT BUT IT QUICKLY GOT OUT
OF HAND.
SO THAT BECAME A FOOTNOTE.
I SEE A HAND UP?
>> YEAH.
I WANTED TO GO TO YOUR LINE 138.
>> OKAY.
>> AND I WOULD SAY WE NEED TO
REWORD THAT SENTENCE.
IT STARTS AT THE SAME TIME MAY
BE IN PARTICIPANTS' BEST
INTERESTS FOR INSOLVENT SPONSOR.
TWO THINGS.
WE USE A WORD THAT I'M NOT SURE
MANY PEOPLE WILL KNOW, AFTER
COPIES, 139, I WOULD SUGGEST
USING A DIFFERENT WORD.
ALSO WE START OFF TALKING ABOUT
IT MAY BE IN THE PARTICIPANTS'
BEST INTEREST, AND THEN WIND UP
TALKING ABOUT THAT THE MATERIALS
WILL BE PROVIDED TO THE
RESEARCHERS.
AND SO I WANT TO ADD SOME
LANGUAGE ABOUT WHY WOULD IT BE
IN THE BEST INTEREST OF THE
PATIENT, EITHER IN THAT SENTENCE
OR A SEPARATE SENTENCE THAT
FOLLOWS RIGHT AFTER THAT.
>> OKAY.
>> LIKE IS THERE -- MAYBE IN THE
BEST INTEREST BECAUSE
RESEARCHERS WILL THEN TURN THAT
MATERIAL OVER TO THE PATIENT OR
TO THEIR PROVIDERS, JUST WANTED
A CLOSER NEXUS.
>> THAT'S FINE.
I DON'T THINK MARK BARNES IS ON
THE CALL.
HE CAME UP WITH THIS LANGUAGE TO
START WITH.
I'M TRYING TO REMEMBER HIS
RATIONALE FOR -- OR IF HE GAVE
EXAMPLE OF HOW HE THOUGHT THE
RETURN OF COPIES OR SAMPLES TO
THE RESEARCHERS BY THE SPONSORS
WOULD PRODUCE VALUE.
I DON'T THINK HE GAVE A SPECIFIC
EXAMPLE BUT I CAN CHANGE THE
WORD ALIQUOT TO SOMETHING MORE
GENERIC IS EASY ENOUGH.
I'LL SEE IF I CAN COME UP AN
EXAMPLE.
I'LL COME UP WITH AN EXAMPLE OF
WHAT MAY BE FOR THE RESEARCH
TEAM TO GET THOSE BACK FROM A
SPONSOR.
>> YEAH, THAT WOULD BE GREAT.
MAYBE EVEN SAYING INCLUDING
COPIES SAMPLES TO THE
RESEARCHERS AND AFTER THE
RESEARCHERS YOU JUST SAY WHO CAN
PROVIDE IT TO THE PARTICIPANTS
OR THEIR PROVIDERS.
SOMETHING TO THAT EXTENT.
>> OKAY.
I CAN WORK ON THAT.
I WON'T TRY TO WORDSMITH THAT
NOW.
I'LL PULL THAT TOGETHER AT
WHATEVER BREAK TIME IS.
OTHER QUESTIONS OR SUGGESTIONS
IN THIS SECTION?
THE NEXT SECTION FOCUSES ON
INFORMED CONSENT.
IT USED TO BE -- IT WASN'T
ALWAYS CALLED OUT.
LAST TIME YOU SAW IT I DON'T
BELIEVE IT WAS.
AS ISSUES RELATED TO CONSENT
POPPED UP IN A FEW SECTIONS, THE
SUBCOMMITTEE ULTIMATELY DECIDED
WE WOULD PULL IT INTO JUST A
SECTION OF THE DOCUMENT THAT
SORT OF FOCUSES ON INFORMED
CONSENT.
AND THE NEED TO HELP MANAGE
SUSPENSIONS AND TERMINATIONS,
ASPECTS THAT RELATED TO STOPPING
AND STARTING RESEARCH AND
APPROPRIATELY NOTIFYING MEMBERS
OF THE SUBJECT COMMUNITY ABOUT
WHAT'S GOING ON OR WHAT'S
CHANGING ARE CAPTURED IN HERE.
I DON'T KNOW IF FOLKS HAD A
CHANCE TO LOOK AT THIS IN
ADVANCE AND HAVE ANY QUESTIONS
OR CONCERNS OR CHANGES.
>> NEIL?
>> PEOPLE SHOULD LEARN ABOUT
WHAT THEY SHOULD TELL PEOPLE,
THIS COUNTER TO THAT
UNDERSTANDING, AND WHAT NOT,
IT'S DIFFICULT TO FOLLOW.
I THINK IT'S RESTATING THE
SENTENCE BEFORE.
I THOUGHT IT WAS CONFUSING AND
DIDN'T HELP.
>> ON MY SCREEN THE SENTENCE
THAT STARTS WITH THE WORDS IN
175.
>> SORRY FOR THE DOG.
>> IT'S ALL RIGHT.
I BANISHED MINE FROM MY OFFICE
FOR THIS MEETING.
THERE MAY BE REDUNDANCY THERE.
I THINK THE IDEA THAT WE'VE GOT
IN THOSE LINES PROBABLY IS
EXPRESSED THROUGHOUT THE
SESSION.
>> I THINK THE CONFUSING PART IS
THE NOTION OF NEW INFORMATION
THAT COMES TO LIGHT THAT IS
COUNTER TO THAT UNDERSTANDING,
IT'S NOT CLEAR WHAT THAT "THAT
UNDERSTANDING" IS, ESPECIALLY
SINCE THE ONE BEFORE SAYS YOU'RE
OBLIGATED TO TELL PEOPLE ABOUT
THE INTERRUPTION, THE REASON,
IT'S ALL THERE.
SO COUNTER TO THAT UNDERSTANDING
I ASSUME THAT MEANS COUNTER TO
THE INITIAL AGREEMENT, INITIAL
CONSENT, WHAT PEOPLE ARE -- IT'S
FINE IF YOU WANT TO -- JUST
SEEMS RESTATING THE FIRST FEW
SENTENCES, MIGHT BREED
CONFUSION.
>> I DON'T THINK YOU'RE WRONG.
I DON'T HAVE A PROBLEM WITH
LIMITING.
THE IDEA REALLY IS NOT JUST IN
THIS PARAGRAPH BUT I MEAN I
THINK IT'S IN DIFFERENT WAYS
STATED IN EARLIER PARTS OF THE
SECTION AS WELL.
SO UNLESS OTHERS DISAGREE OR
FEEL STRONGLY OR HAVE A
SUGGESTION FOR HOW TO CHANGE
THAT SENTENCE OR CHANGE EVEN THE
PHRASE THAT IS COUNTER TO THAT
UNDERSTANDING BECAUSE I THINK
YOU'RE RIGHT, NEIL, WHAT WAS
MEANT TO BE UNDERSTOOD HERE, NO
PUN INTENDED, IT'S COUNTER TO
WHAT WAS PREVIOUSLY -- WHAT
SUBJECTS WERE PREVIOUSLY TOLD.
I'M GOING TO LEAVE THAT STRUCK
UNLESS SOMEBODY WANTS TO DEFEND
IT OR HAS A SUGGESTION FOR
IMPROVEMENT.
ALL RIGHT.
OTHER QUESTIONS ABOUT -- OR
COMMENTS ON THE CONSENT SECTION
BUT WE MOVE ON TO THE QUESTIONS
FROM OHRP?
>> DAVE, I WANT TO SAY I THOUGHT
THE CONSENT SECTION WAS REALLY
GOOD.
>> WELL, THANKS, LOIS.
I APPRECIATE THE FEEDBACK.
I KNOW THE GROUP WILL AS WELL.
ALL RIGHT.
AND THEN --
>> ONE SMALL THING.
THERE'S A PERIOD IN ONE OF THE
SENTENCES, ON YOUR LINE 169.
>> THANK YOU.
ALL RIGHT.
WE MOVE TO THE SECTION, THESE
ARE THE QUESTIONS FROM THE
ORIGINAL CHARGE FROM OHRP FOR
SACHRP TO CONSIDER.
AND WE CAN DISCUSS THEM ONE BY
ONE.
I KNOW THERE'S PROBABLY AT LEAST
ONE OR TWO THAT WILL -- WHERE
THEY HAVE BEEN DISCUSSED AT
SUBCOMMITTEE AND WE'LL PROBABLY
HAVE SOME DISCUSSION HERE.
I THINK THE RESPONSE IN THE
FIRST -- GO AHEAD, NEIL.
>> SUPER MINOR.
FRIENDLY AMENDMENT ON 185,
RELATED TO WHAT SOMEONE BROUGHT
UP EARLIER.
IT MAY OR MAY NOT BE AN
EXPERIMENTAL INTERVENTION.
IT'S JUST SOMETHING THAT'S
AVAILABLE.
I DON'T KNOW THE RIGHT WORD,
PROCEDURE, INTERVENTION,
WHATEVER LANGUAGE YOU MAY WANT
TO USE.
>> IS THAT BETTER?
>> SURE.
>> OKAY.
QUESTION 2 SUMMARIZES I THINK
THINGS THAT HAVE BEEN ALREADY
EXPRESSED IN THE DOCUMENT BUT
ARE HERE BECAUSE IT WAS THE --
PART OF THE LIST OF QUESTIONS
FROM SACHRP.
THIS ONE I THINK IS PRETTY
STRAIGHTFORWARD.
>> I'M DISTINGUISHING MYSELF AS
A PAIN IN THE NECK.
I RAISED CONCERN ABOUT LINE 200.
I LOOKED AT THE MINUTES, SO I
KNOW THAT.
THERE WAS SOMETHING ABOUT -- I
DON'T UNDERSTAND.
CONSIDER THE WILLINGNESS OF
SUBJECTS TO GIVE THEIR CONSENT
TO ONGOING PARTICIPATION.
I DON'T KNOW, THAT SOUNDS LIKE
PROBABILISTIC ASSESSMENT OF
WHETHER PEOPLE ARE LIKELY TO SAY
YES.
I DON'T KNOW WHAT THAT MEANS.
WE'VE ALREADY SAID YOU NEED TO
GET CONSENT.
I'M NOT SURE WHAT THE
WILLINGNESS -- IT SEEMS LIKE A
PREDICTIVE ASSESSMENT THAT I
DON'T UNDERSTAND THE PURPOSE OF.
IF YOU THINK IT'S IMPORTANT, YOU
ASK THEM.
I DON'T KNOW WHY WE WOULD MAKE
AN ASSESSMENT WHETHER WE THINK
THEY WOULD BE LIKELY TO DO IT.
>> YEAH, I MEAN I DON'T KNOW IF
THIS HELPS.
ONE OPTION WOULD BE IF IT SAID
THE ABILITY TO OBTAIN CONSENT.
>> IS IT ABOUT FEASIBILITY?
LIKE WE COULD GET CONSENT FOR
ONGOING PARTICIPATION?
OR IS IT ABOUT THE NOTION OF IT
WOULD BE LIKELY PEOPLE WOULD SAY
YES?
>> I THINK IT'S THE LATTER.
AND MY MEMORY IS IT'S THE
LATTER.
IF IT'S THE LATTER THEN YOUR
ARGUMENT FOR WHY IT SORT OF IS A
STRANGE FIT HERE MAY BE VALID.
BUT I'M STRUGGLING WITH HOW TO
-- IF MY MEMORY IS CORRECT THAT
IT'S ABOUT THE LATTER CONCERN.
I'M NOT -- I'M STRUGGLING WITH
HOW TO MODIFY IN A WAY THAT
MAKES IT SEEM LIKE A REASONABLE
-- HOW TO TURN IT INTO A
CONSIDERATION VERSUS JUST A
STATEMENT.
MAYBE IT SHOULDN'T BE HERE AND
IT'S PRESUMED OBVIOUSLY YOU'LL
HAVE TO OBTAIN CONSENT TO DO
THIS AND IF PEOPLE WANT TO GIVE
CONSENT THEY CONTINUE ON, IF NOT
THEY SAY I'M OUT.
THERE'S NOT AN ASSESSMENT, IT'S
JUST THE REALITY OF IT.
>> I'M NOT GOING TO -- THIS IS
NOT ONE I FEEL SUPER STRONGLY B
I -- ABOUT.
IT'S HELPFUL TO UNDERSTAND WHY
SOMETHING'S THERE.
ESPECIALLY IF IT'S ONE THAT
COULD BE INTERPRETED MULTIPLE
DIRECTIONS.
IF OTHERS DON'T HAVE CONCERNS I
DON'T THINK IT CAUSES PROBLEMS,
I JUST DON'T REALLY KNOW WHAT IT
DOES.
>> NEIL, I'M IN AGREEMENT.
I DO THINK IT'S AWKWARD.
DAVE, WHAT YOU'RE GETTING AT, OR
BOTH GETTING AT, PRACTICALITY IS
MAYBE WHAT WE WERE GOING AT, OF
OBTAINING CONSENT BUT IT DOESN'T
ADD ANYTHING NECESSARILY.
I THINK WE PROBABLY COULD TAKE
IT OUT.
>> THIS TALKS ABOUT THE NEED TO
KEEP INDIVIDUALS INFORMED ABOUT
THE STATUS OF PARTICIPATION, IF
YOU GET RID OF THAT IT DOESN'T
DEGRADE THE DOCUMENT IN ANY WAY.
>> I AGREE.
>> PEOPLE FEEL LIKE THERE'S
SOMETHING THAT NEEDS TO BE
THERE, YOU COULD SAY SOMETHING
LIKE DO SUBJECTS WANT TO
CONTINUE TO HAVE ACCESS, RIGHT?
THAT'S SORT -- IF IT'S LIKELY
PEOPLE MIGHT WANT WHAT'S
PROVIDED THAT'S DIFFERENT FROM
SOMETHING ABOUT WILLINGNESS TO
GIVE CONSENT, YOU KNOW WHAT I
MEAN?
>> UH-HUH.
>> THAT'S THE CRITERION IF IT'S
SOMETHING SEEN AS VALUABLE TO
THE SUBJECTS, I WOULDN'T HAVE A
PROBLEM WITH A STATEMENT LIKE
THAT.
THAT'S NOT ABOUT THEIR
WILLINGNESS TO GIVE CONSENT,
JUST DO THEY WANT WHATEVER WOULD
BE OFFERED.
>> YEAH.
I THINK I'LL GO WITH STRIKE.
LOIS?
>> LOOKS AS IF YOU WERE GOING TO
STRIKE IT.
THAT ACTUALLY I THOUGHT WAS AN
IMPORTANT POINT.
WE'RE WE'RE GIVING LIKE WHAT ARE
THE ISSUES AN IRB SHOULD
CONSIDER, SEEMS LIKE ONE OF THEM
THAT THEY SHOULD CONSIDER IS,
YOU KNOW, WHAT ARE
INVESTIGATORS, YOU KNOW, HEARING
FROM SUBJECTS WITH RESPECT TO
THEIR DESIRE TO CONTINUE
PARTICIPATING BECAUSE THEY
PERCEIVE A BENEFIT OR MAYBE EVEN
THEIR PROVIDER HAS TOLD THEM
THEY HAVE A BENEFIT.
SO IT SEEMS IF THIS IS A LIST OF
THE THINGS AT A MINIMUM
STAKEHOLDERS SHOULD CONSIDER IT
SEEMS, YOU KNOW, INDICATIONS OF
THE, YOU KNOW, SUBJECT'S DESIRES
TO CONSIDER PARTICIPATING FOR
THEIR OWN BENEFIT OR SOMETHING
LIKE THAT.
I THINK THERE MIGHT BE SOMETHING
VALUABLE ABOUT KEEPING IT BUT
NOT IN THE WAY IT IS.
BUT MORE LIKE WHAT YOU WERE JUST
SAYING.
>> MINDY?
>> YEAH, SOMETHING MAYBE ABOUT
THE PERCEIVED VALUE.
I THINK SOMEBODY JUST SAID
SOMETHING, MIGHT HAVE BEEN LOIS,
THE VALUE OF WHAT PEOPLE WOULD
GET FROM ONGOING PARTICIPATION
WHICH GOES TO ERIC'S COMMENT IN
A SUBCOMMITTEE ABOUT, YOU KNOW,
THE VALUE OF WHAT SOME PEOPLE
ARE RECEIVING BECAUSE THEY WERE
IN THE RESEARCH, BE IT NEIL, ALL
THAT KIND OF THING, KIND OF A
SLIPPERY SLOPE BUT JUST
PERCEPTION OF VALUE TO ONGOING
PARTICIPATION.
I DON'T KNOW IF THAT HELPS OR IS
WORSE.
>> IT WOULD BE LIKE I DON'T KNOW
--
>> IF YOU JUST SAID SUBJECT'S
INTEREST OR DESIRE FOR ONGOING
PARTICIPATION MAY BE SUFFICIENT.
IF THE POINT IS TO GET THE
SUBJECT'S INTEREST ON THE TABLE,
WHAT THEY CARE ABOUT, I THINK
SOMETHING REALLY SIMPLE WOULD BE
GOOD.
IT JUST GETS CONVOLUTED WHEN YOU
TALK ABOUT WILLINGNESS TO GIVE
CONSENT IN TERMS THAT ARE
DIFFERENT FROM INITIAL -- YOU
KNOW, MAYBE SUBJECT'S DESIRE FOR
ONGOING PARTICIPATION.
>> SO I'M WONDERING IF THIS IS
IN ADDITION TO UNDERSTANDING THE
WILLINGNESS OF SUBJECTS TO GIVE
CONSENT, IS THIS ALSO TRYING TO
GET AT THE ABILITY TO ACTUALLY
ADMINISTER CONSENT ON THIS
CONTINUING EFFORT?
>> MY MEMORY IS, NO, IT'S NOT
THAT BECAUSE THERE WAS
ASSUMPTION THAT IF INDIVIDUALS
WANTED ACCESS TO INTERVENTION
MUST BE ACCESSIBLE TO THE
INVESTIGATORS TO BE ABLE TO
CONTINUE ADMINISTRATION OR
PROVIDING THE INTERVENTION,
WHATEVER IT MIGHT BE.
AND SO THAT IF THEY WERE ABLE TO
HAVE CONTACT IN ORDER TO
IMPLEMENT STUDY PROCEDURES THEN
THAT'S SUFFICIENT CONTACT TO BE
ABLE TO OBTAIN REVISED CONSENT
TO THOSE MODIFIED PROCEDURES, TO
THE MODIFIED -- TO THE STUDY AS
MODIFIED AS A RESULT OF
SUSPENSION OR TERMINATION.
I
>> I SEE.
THANKS.
>> I LIKE NEIL'S INTEREST.
AND I THINK THAT'S GREAT.
I THINK THAT CAPTURES A LOT.
>> LOIS, TO YOUR POINT, I MEAN,
SO I'M FINE WITH THIS BULLET THE
WAY IT'S CHANGED.
IF YOU STILL THINK THERE SHOULD
BE ONE ABOUT CONSENT --
>> NO, I DON'T THINK I WAS
MAKING THAT.
>> OH, OKAY.
>> I THINK THIS IS A GOOD FIX.
>> OKAY.
NUMBER 3 IS ABOUT, YOU KNOW,
BALANCING THIS IDEA OF BEST
INTEREST OR JUSTIFYING BEST
INTEREST WHEN THE SAME CARE OR
TREATMENT IS AVAILABLE OUTSIDE
THE RESEARCH AND WHAT ABOUT
ACCESS TO CARE OR BARRIERS TO
ACCESS, WHERE DOES THAT FIT INTO
THE DISCUSSION.
AND SO THIS ONE HAS HAD QUITE A
BIT OF DISCUSSION, SO WHAT'S
HERE IS SORT OF THE CONSENSUS
STATEMENT.
SO I'M CURIOUS TO GET FEEDBACK.
THERE WERE A VARIETY OF OPINIONS
ON IT.
>> SO, DAVE, I DO HAVE A
QUESTION, JUST IN TERMS OF WHAT
THE COMMITTEE HAD DISCUSSED.
THE LANGUAGE AROUND IF SUBJECTS
CAN OBTAIN THE SAME CARE OR
TREATMENT OUTSIDE OF THE
RESEARCH, THAT'S INCLUSIVE OF
THEIR FINANCIAL ABILITY TO
OBTAIN THE CARE?
>> THAT WAS ONE OF THE POINTS OF
DEBATE.
HOW FAR DOES OBLIGATIONS OF THE
RESEARCH TEAM EXTEND TO USING
THE RESEARCH AS A VESSEL OR
MECHANISM TO CONTINUE TO PROVIDE
CARE THAT'S ALSO AVAILABLE
OUTSIDE THE RESEARCH BUT IS
MAYBE BEYOND THE FINANCIAL MEANS
OR THE POPULATION, WHATEVER THE
CASE MAY BE, BUT THEY HAVE
ACCESS, IT'S THERE, BUT NOT
EVERYBODY HAS OPEN ACCESS TO IT.
HOW DO YOU BEST -- THIS IS WHERE
THE COMMITTEE I THINK DEBATED A
BIT.
ERIC?
>> SORRY, SANDRA, WERE YOU GOOD?
>> I JUST WANTED TO MAKE THE
POINT THAT, YOU KNOW, THIS
DOESN'T ADDRESS UNEVEN ACCESS
WITHIN A STUDY POPULATION SO I'M
WORRIED ABOUT ISSUES WITH
RESPECT TO EQUITY.
>> SO I'M GENERALLY IN FAVOR,
WONDERING IF NUMBER 3 IS ONE
THAT DESERVES A QUALIFIER LIKE
USUALLY NO INSTEAD OF SAYING NO
TO GIVE SOME WIGGLE ROOM.
I THINKS THE TENSION IF I
REMEMBER THE LAST MEETING
CORRECTLY, I WASN'T ADVOCATING
FOR THIS NECESSARILY BUT
UNDERSTANDING I THINK WAS THAT
LET'S SAY RESEARCHER WAS WORKING
WITH UNHOUSED POPULATION, AND TO
SUDDENLY CUT OFF THE RESEARCH
WHEN THE RESEARCH MIGHT THEN
RESTART TWO MONTHS LATER WOULD
BE DAMAGING TO THE RESEARCH
STUDY.
SO CAN YOU CONTINUE CERTAIN
ASPECTS OF THE STUDY TO MAINTAIN
THAT RELATIONSHIP AT THE
DETRIMENT OF, YOU KNOW, OH,
WE'RE FOLLOWING THE RULES, CAN
WE CONTINUE THAT VISIT BUT MAYBE
NOT THROUGH DO THE INTERVENTION,
I THOUGHT SOME MEMBERS OF THE
COMMITTEE WANTED SOME
FLEXIBILITY HERE, AND IN CERTAIN
CASES.
AND SO IF THERE'S ONE OF THESE
THAT I THINK A USUALLY QUALIFIER
COULD BE APPROPRIATE THIS MIGHT
BE ONE.
THAT'S THE ONLY SUGGESTION I
HAVE BUT OPEN TO OTHERS.
>> YEAH, THIS WAS A CHALLENGING
ONE FOR THE GROUP.
USUALLY IT'S AN EASY FIX FOR ME
BUT WE HAD A LOT OF DEBATE.
IT WAS HARD TO PICK THE -- WE
DIDN'T GET TO A UNANIMOUS
PATHWAY HERE.
IT WAS LIKE I SAID MORE OF A
CONSENSUS POINT.
>> I AGREE WITH ERIC, ADDING THE
USUALLY NO BECAUSE IT'S A
SUMMARY OF WHAT ELSE IS IN THE
PARAGRAPH, SORT OF NO BUT THEN
YOU GO ON TO GIVE EXAMPLES OF
WHY IT COULD BE YES.
>> OKAY.
I THINK, AND I APPRECIATE ERIC'S
BEEN PARTICULARLY A CHAMPION FOR
GETTING THE LANGUAGE RIGHT IN
THIS SECTION IN THE SUBCOMMITTEE
CALLS.
STARTING NEAR THE END OF LINE
209 HERE WE DID TRY TO FIGURE
OUT HOW TO THREAD THE NEEDLE AND
HIGHLIGHT, YOU KNOW, LEGITIMATE
ISSUES AROUND ACCESS TO CARE,
AND ESSENTIALLY SAYING THAT
THERE'S NOTHING WRONG WITH
CONSIDERING THOSE BUT STOPPING
SHORT OF SAYING THERE'S ALSO,
YOU KNOW, WE ALSO DIDN'T SAY
THERE'S AN OBLIGATION YOU HAVE
TO FIGURE OUT HOW TO CONTINUE IT
BECAUSE OF THOSE BARRIERS TO
ACCESS.
SO LIKE I SAID USUALLY IS A FINE
FIX FOR ME BECAUSE I THINK THE
ANSWER ITSELF SORT OF TRIES TO
SHED LIGHT ON BOTH SIDES OF THE
COIN.
ALL RIGHT.
NUMBER 4, THIS ONE I DON'T THINK
HAS REALLY CHANGED A WHOLE LOT.
SHOULD BEST INTERESTS BE MADE ON
INDIVIDUAL GROUP OR STUDY-WIDE
BASIS, THE ANSWER WAS SORT OF
DEPENDS BUT COULD BE ANY OF
THOSE.
LOIS?
>> I JUST THOUGHT THE SECOND
SENTENCE WAS DIFFICULT TO
FOLLOW.
THE PRIMARY INTENT OF THE BEST
INTEREST DETERMINATION IS TO
PREVENT HARM AND EXTEND DIRECT
BENEFIT TO SUBJECTS AT THE
INDIVIDUAL LEVEL THAT RESULT
FROM SUSPENSION OR TERMINATION
OF RESEARCH.
AND I THINK THE LAST PART, THAT
RESULT FROM SUSPENSION OR
TERMINATION OF RESEARCH, SHOULD
COME AFTER IS TO PREVENT HARM
BECAUSE IT'S NOT -- DOESN'T
APPLY TO THE EXTENT DIRECT
BENEFIT TO SUBJECTS, RIGHT?
SO I THINK IT'S THE PRIMARY
INTENT OF THE BEST INTEREST
DETERMINATION TO PREVENT HARM,
MAYBE PREVENT HARM THAT RESULTS
FROM SUSPENSION OR TERMINATION
OF RESEARCH AND EXTEND DIRECT
BENEFIT.
>> THAT WOULD LOOK LIKE THIS.
>> THAT MIGHT NOT RESOLVE IT ALL
BUT THE THOUGHT THE LAST PART
WAS NOT IN THE RIGHT PLACE.
BECAUSE OTHERWISE IT WAS SAYING
EXTEND DIRECT BENEFIT TO
SUBJECTS AT THE INDIVIDUAL LEVEL
THAT RESULT FROM THE SUSPENSION.
SO THAT DIDN'T MAKE SENSE TO ME.
>> YEAH.
THIS IS WHAT IT WOULD --
TRACKING TURNED OFF, THIS IS
WHAT IT WOULD LOOK LIKE CHANGED.
THE THOUGHT BEHIND THIS, THE
THOUGHT BEHIND THE ANSWER IS
THAT -- WELL, YEAH.
I WOULD HAVE TO REMEMBER WAY
BACK.
I DON'T WANT TO BE WRONG.
WHAT WE WERE TRYING TO SAY, YOU
KNOW, TO SOME EXTENT, YOU KNOW,
THE WAY -- I'M NOT THINKING OFF
THE CUFF GOOD ON THIS ONE.
I DON'T HAVE A PROBLEM WITH THIS
CHANGE.
I THINK THAT AT THE END OF THE
DAY I THINK WE'RE CLEAR THAT YOU
CAN MAKE THESE DETERMINATIONS AS
APPROPRIATE WHETHER IT'S ON THE
INDIVIDUAL LEVEL OR, YOU KNOW,
ONE ARM OF THE STUDY OR THE
WHOLE STUDY AND THAT'S OKAY.
>> RIGHT.
I KNOW THIS IS JUST A WORDING
THING.
PUT AN S ON THE END OF HARM
THOUGH FOR YOUR VERBS TO WORK.
>> THANK YOU.
NUMBER 5, THIS ONE I DON'T THINK
HAS CHANGED.
CAN YOU THINK ABOUT BEST
INTERESTS IN STUDIES THAT
HAVEN'T STARTED.
WE SAID NO, THE STUDY HASN'T
STARTED SO IT'S HARD TO SAY THAT
NOT STARTING THE STUDY THAT
NEVER STARTED IS CREATING A BEST
INTEREST PROBLEM.
THERE MAY HAVE BEEN PEOPLE THAT
WANTED TO BE IN THE STUDY BUT
THERE HASN'T BEEN EXPOSURE TO
INTERVENTION, NOTHING YOU'VE
STOPPED IN ITS TRACKS THERE.
LOIS, IS THAT YOUR HAND UP
FRESH?
>> IT'S FRESH, UNFORTUNATELY.
I THINK WE'RE MISSING A WORD.
>> OKAY.
>> 224, I THINK THE RESEARCH
WILL NOT BE ALLOWED, I THINK
YOU'RE JUST MISSING A "BE."
>> THANK YOU.
QUESTION 6 ALSO TOOK OR LED TO
DISCUSSION ON THE PART OF THE
SUBCOMMITTEE AS WE TALKED
THROUGH THIS.
AND SOME OF IT I THINK WAS
TRYING TO FIGURE OUT WHAT THE
QUESTION IS ASKING.
A COUPLE TIMES WE STARTED TO GO
QUITE FAR DOWN RABBIT HOLES, IN
MY OPINION, SORT OF DEVIATED
FROM WHAT THE QUESTION WAS
ASKING.
BUT THIS IS SORT OF WHERE WE
ENDED UP.
THE QUESTION IS WHETHER THE
DETERMINATION IS EVER JUSTIFIED
FOR PLACEBO-CONTROLLED STUDY
WHERE PLACEBO IS ABSENCE OF
POTENTIALLY BENEFICIAL
INTERVENTIONS.
SO THE ANSWER STARTS OFF BY
SAYING, WELL, YOU KNOW, THE
BEST -- TELLING SOMEBODY OR
SAYING THAT PEOPLE IN THE
PLACEBO ARM, THAT THERE'S A BEST
INTEREST ARGUMENT, ISN'T
APPROPRIATE BECAUSE BY -- WHILE
THERE'S A PLACEBO EFFECT, THE
THOUGHT IS THAT THERE'S NOT --
IT'S NOT THE INTERVENTION THAT'S
CAUSING AN EFFECT.
AND THEREFORE IT'S EXCLUDED FROM
A BEST INTEREST DISCUSSION.
AND WE CALLED OUT THE PEDIATRIC
GUIDES IN THE FDA FOR COMPONENT
ANALYSIS SAYS IF IT'S A PLACEBO
INTERVENTION OR PROCEDURE YOU
CAN'T SAY THERE'S A PROSPECT OF
DIRECT BENEFIT.
WHICH IS PROBABLY AS CLOSE AS WE
GOT TO A REGULATION IN A LOT OF
THIS DOCUMENT, BUT THERE IT IS.
THE SECOND HALF OF THIS WE
TALKED A BOUGHT WILL BEHAVIORAL
RESEARCH STUDIES WITHOUT
LIFESTYLE COMPONENTS.
ANYHOW, THIS, AGAIN, WAS ONE OF
THE ONES WHERE WE GOT A
CONSENSUS ANSWER FOR YOU ALL TO
THINK ABOUT, AND I'LL OPEN IT UP
FOR DISCUSSION.
IF IT'S CLEAR, THAT'S GREAT.
NEIL?
>> YEAH, THE ONLY VERY MINOR
THING I MIGHT CONSIDER IS I GOT
STUCK ON THE STATEMENT THAT
CONTINUATION OF PLACEBO IS NOT
ALIGNED WITH THE SUBJECT'S BEST
INTEREST.
IT MIGHT BE ALIGNED BUT MORE OF
THE SECOND SENTENCE THAT WE
GENERALLY DON'T DO PLACEBO
TREATMENT BASED ON, YOU KNOW, SO
I FELT LIKE IT MIGHT BE MORE
STRAIGHTFORWARD TO SAY SOMETHING
LESS CONTENTIOUS, CONTINUATION
OF PLACEBO IS NOT CONSISTENT
WITH TYPICAL CLINICAL PRACTICE
OR SOMETHING LIKE THAT.
THE WHOLE POINT IS IT'S ALL
ABOUT CLINICAL INDICATIONS
REALLY AND SO I COULD SEE
SOMEBODY PICKING AT THINGS THE
POINT WHETHER IT IS OR ISN'T IN
SOMEONE'S BEST INTEREST.
THE POINT IS WE JUST DON'T DO
IT.
>> YEAH.
>> SOMETHING LIKE CONTINUATION
OF PLACEBO FOR CLINICAL PURPOSES
IS NOT CONSISTENT WITH TYPICAL
CLINICAL PRACTICE.
I DON'T KNOW.
JUST SEEMS LESS -- LESS
TECHNICAL.
>> LET'S SEE WHAT PEOPLE THINK.
>> OR CONTINUATION OF PLACEBO IS
NOT ALIGNED WITH STANDARD OF
CARE.
I COMPLETELY AGREE WITH NEIL.
WHEN YOU TRIED TO TELL PEOPLE
YOU CAN'T DO A
PLACEBO-CONTROLLED TRIAL IF WE
KNEW THE PLACEBO WAS GOING TO
HURT PEOPLE AND THERE'S A LINE
THAT SAYS PLACEBO IS NOT ALIGNED
WITH SUBJECT'S BEST INTEREST, I
WOULDN'T WANT TO SEE THAT IN
PARENTHESES.
>> RIGHT.
>> IT SEEMS FINE FOR ME.
LESS LIKELY TO CAUSE A FOIBLE.
>> OKAY.
LET ME LOOK AT THAT FOR A SECOND
BEFORE I SCROLL ON.
ALL RIGHT.
NUMBER 7, CONSIDERATIONS SUCH AS
LOST TIME OR EFFORT, LOST
RESEARCH COMPENSATION.
>> SORRY, DAVE.
GO BACK.
THERE'S A REFERENCE TO PLACEBO
EFFECT, AND MAYBE MAY
EXPERIENCE, 233, MAYBE I'M
OVERREADING IT.
WHILE THERE MAY BE INDIVIDUAL
SUBJECTS WHO EXPERIENCE A
PLACEBO EFFECT, IS THAT WHAT YOU
WANT TO SAY?
>> YEAH, THE GROUP SAID, LOOK,
THERE ARE PEOPLE THAT RESPOND TO
PLACEBO, AT LEAST IN A CLINICAL
TRIAL WORLD.
THAT'S EXPECTED.
IT'S GOING TO HAPPEN.
>> OKAY.
>> THAT WAS INTENTIONAL.
>> OKAY.
>> ALL RIGHT.
NUMBER 7, THIS IS ONE WHERE THE
SHORT ANSWER WAS NO.
I THINK THESE ARE REALITIES BUT
IN AND OF THEMSELVES DON'T
REPRESENT THE BASIS FOR A BEST
INTEREST ARGUMENT.
THIS HASN'T CHANGED IN QUITE
SOME TIME.
>> ON 252 I THINK THERE'S A BE
IN BETWEEN SHOULD AND NOT.
SHOULD NOT -- I'M SORRY, SHOULD
NOT BE DETERMINATIVE.
>> QUESTION 8 IS THE -- YOU
KNOW, WHAT ABOUT WHEN THERE'S A
THERAPEUTIC RELATIONSHIP BETWEEN
THE RESEARCHERS AND THE
PARTICIPANTS.
I THINK THIS IS ONE WHERE WE
SORT OF STAKED OUT THIS ANSWER
QUITE SOME TIME AGO AND IT
REALLY HASN'T CHANGED.
>> THE ONLY THING I HAVE A
CONCERN WITH ABOUT 8 WAS THAT IT
STRIKES ME AS NARROWLY
CONSTRUCTED AROUND PREEXISTING
RELATIONSHIPS, AND I WASN'T
PRESENT WHEN THE CHARGE WAS
CREATED OR WHEN THIS FIRST GOT
ASKED BUT IT SEEMS THERE ARE TWO
CIRCUMSTANCES THERAPEUTIC
RELATIONSHIPS CAN BECOME
RELEVANT.
ONE WHEN THERE'S A PREEXISTING
RELATIONSHIP WHICH IS COVERED.
SECOND IS WHEN THERAPEUTIC
RELATIONSHIP IS ESTABLISHED IN
THE CONTEXT OF RESEARCH
PARTICIPATION WHICH DOES HAPPEN,
AND I JUST WASN'T SURE IF THIS
WAS THE RIGHT -- IF THIS WAS TOO
NARROW A SCOPE.
>> YEAH, I DON'T KNOW.
WE HAVEN'T FOCUSED ON
SUBCOMMITTEE LEVEL IN A WHILE
IT'S FUNNY BECAUSE THE SENTENCE,
THE SECOND MAIN SENTENCE, ALMOST
REDUNDANT, PREEXISTING CLINICAL
CARE PROVIDER ... I'LL THINK
ABOUT THAT FOR A MINUTE.
LOIS?
>> WELL, I THINK NEIL'S POINT IS
A GREAT ONE.
AND I THINK WE SHOULD BROADEN
IT.
IN FACT THE SENTENCE, THE
QUESTION IS ABOUT A THERAPEUTIC
RELATIONSHIP.
IT'S NOT ABOUT WHETHER IT'S
ESTABLISHED BEFORE OR DURING
RESEARCH.
SO, I THINK IT'S JUST A WORDING
THING BUT IT COULD BE
THERAPEUTIC RELATIONSHIP, YOU
KNOW, IT COULD BE WHETHER
ESTABLISHED BEFORE OR DURING
RESEARCH, YOU KNOW, SHOULD NOT
BE DETERMINING, OR SOMETHING
LIKE THAT.
>> YEAH.
>> AND JUST GET RID OF
PREEXISTING IN LINE 254.
I DID NOT FIND THE SECOND
SENTENCE TOO REPETITIVE.
I THOUGHT IT WAS HELPFUL, FOR
ME, BECAUSE THIS RELATIONSHIP IS
NOT IN AND OF ITSELF.
IT SAID THERE'S A ROLE HERE
THAT'S IMPORTANT.
>> RIGHT.
>> SO IF WE CAN GO BACK THEN, I
WANT TO MAKE SURE I'M GETTING IT
RIGHT, NEIL.
IS THE WAY THE SENTENCE START
WHAT'S WRONG?
I SEE JULIE HAS A HAND UP.
DO YOU HAVE A CLARIFICATION FROM
OHRP SIDE?
>> YEAH.
HI, DAVID.
YEAH, I JUST WANTED TO MENTION
THAT WHEN WE PUBLISHED THIS
QUESTION IT WAS ACTUALLY NOT IN
THE CONTEXT OF WHERE THERE WAS A
PREEXISTING RELATIONSHIP BETWEEN
THE HEALTH CARE PROVIDER AND THE
NOW RESEARCH PARTICIPANT BUT
ACTUALLY WHERE THAT RELATIONSHIP
WAS DEVELOPED AS PART OF THE
PARTICIPATION IN THE RESEARCH
ITSELF.
AND THAT THAT WAS THE RATIONALE
FOR THE CONTINUATION OF
PARTICIPATION IN THE RESEARCH.
I HOPE THAT'S HELPFUL.
>> IF THAT'S THE CASE, I THINK
WHAT WOULD NEED TO GET -- THE
HELPFUL CHANGE WOULD BE TO ADD A
SENTENCE EITHER BEFORE OR
AFTERWARDS WHICH COULD SAY NO,
THERAPEUTIC RELATIONSHIPS MAY BE
ESTABLISHED IN THE CONTEXT OF
RESEARCH PARTICIPATION OR IN
ADDITION TO PREEXISTING
RELATIONSHIPS MAY BE PRESENT.
AND I THINK THEN THE SECTION
ABOUT WHEN THE INVESTIGATOR'S
ALSO A CLINICAL CARE PROVIDER
MAY HAVE INPUT TO AID, IT FEELS
LIKE THE POINT THAT WE'RE TRYING
TO MAKE IS THAT DOESN'T
NECESSARILY JUSTIFY CONTINUED
RESEARCH PARTICIPATION BUT THAT
WE HAVE TO FIND WAYS TO NAVIGATE
THE CLINICAL RELATIONSHIPS THAT
HAVE BEEN -- THAT EXIST, WHETHER
PREEXISTING OR DE NOVO.
>> OKAY.
THIS WILL BE ONE I'LL WORK ON AT
THE BREAK AS WELL.
IT WILL TAKE A LITTLE BIT OF
THOUGHT BUT HOPEFULLY I CAN COME
BACK WITH SOMETHING WE CAN LOOK
AT LATER IN THE AGENDA TODAY.
>> SORRY TO THROW A WRENCH IN
THE WORKS.
IT'S IMPORTANT TO BE CLEAR,
BECAUSE I THINK THERAPEUTIC
RELATIONSHIPS THAT GET
ESTABLISHED IN THE CONTEXT --
TRUTH IS ONCE THEY GET
ESTABLISHED IN CONTEXT OF
RESEARCH PARTICIPATION WHERE
THERE ISN'T SOMETHING
PREEXISTING ARE PROBABLY MORE
IMPORTANT AND MORE CHALLENGING
THAN ONES PREEXISTING BECAUSE
PREEXISTING ONES YOU JUST -- THE
ANSWER IS GO BACK TO WHAT YOU
WERE DOING BEFORE.
>> RIGHT.
OKAY, I'LL WORK ON THAT.
AND NUMBER 9 -- OH, MINDY, DID
YOU HAVE A COMMENT ON 8?
>> I DO.
DOES THIS FIX THE FIDUCIARY DUTY
THING BACK IN 104?
BECAUSE WE'RE TALKING ABOUT A
THERAPEUTIC OBLIGATION, AND I
DON'T WANT TO -- YOU CAN LOOK AT
THIS AT THE BREAK, BUT WHEN WE
ALL HAD PROBLEMS IS THERE A
FIDUCIARY DUTY OWED TO SUBJECTS
BY RESEARCHERS, IF THERE'S A
THERAPEUTIC OBLIGATION TO
SUBJECTS BY RESEARCHERS?
I'M WONDERING IF THIS SECTION
KIND OF ANSWERS OUR DISLIKE OF
FIDUCIARY DUTY IN 104, MIGHT BE
HELPFUL FOR THE LANGUAGE TO BE
REPLACED, FIDUCIARY THERE.
SOMETHING TO THINK ABOUT.
>> OKAY, THANKS.
AND NUMBER 9 WHEN A BEST
INTEREST DETERMINATION IS MADE
TO ALLOW ONE OR MORE
PARTICIPANTS TO CONTINUE IN THE
RESEARCH SHOULD DATA COLLECTION
TOWARD THE SCIENTIFIC OBJECTIVES
CONTINUE?
WHAT ABOUT OTHER ANCILLARY
RESEARCH PROCEDURES?
I THINK LAST TWO LINES SUM UP
THE SUBCOMMITTEE'S FEELINGS,
WHEN THE STUDY IS BEING
TERMINATED OR EXPECTED TO BE
TERMINATED COLLECTING ADDITIONAL
DATA AND CONDUCTING OTHER
ANCILLARY PROCEDURES THAT DON'T
HAVE IMPACT, DIRECT IMPACT ON
SUBJECT BEST INTEREST SHOULD BE
DISCONTINUED.
ALLISON?
OR NEIL IS YOUR HAND UP?
JUST UP FROM BEFORE?
YEAH, ALLISON?
SORRY.
>> WELL, I THINK, YOU KNOW, WHAT
DO YOU MEAN BY DO NOT HAVE A
DIRECT IMPACT ON SUBJECT'S BEST
INTEREST?
I'VE ALREADY COME OUT IN FAVOR
OF SAYING YOU SHOULD CONTINUE
COLLECTING SAFETY DATA BECAUSE
IF SOMETHING ELSE COMES UP YOU
MAY END UP, EVEN THE PART OF THE
RESEARCH THAT YOU HAD RESUMED.
>> YEAH, I THINK THAT'S AN
EXCELLENT POINT.
>> I AGREE COLLECTING ANCILLARY
RESEARCH PROCEDURES, THAT'S A
NO-GO BUT --
>> RIGHT.
I THINK IT WILL BE PRETTY EASY
TO WEAVE IN A SENTENCE THAT SORT
OF CARVES OUT THIS IDEA THAT
THERE WILL BE DATA SUCH AS
SAFETY DATA THAT'S IMPORTANT TO
KEEP COLLECTING AND IS I THINK
YOU COULD MAKE AN ARGUMENT IT
PROBABLY IS IN THE SUBJECT'S
BEST INTEREST TO CONTINUE
COLLECTING SAFETY DATA,
POTENTIAL FOR DIRECT IMPACT ON
THEM AS THEY WERE EXPOSED TO THE
INTERVENTION OR WHATEVER THE
RESEARCH PROCEDURE WAS.
>> AND THEN, YOU KNOW, THAT
RAISES THE QUESTION WHAT DO WE
MEAN BY SAFETY DATA?
CERTAIN TIMES OF GENE THERAPY,
FDA ASKED FOR 15 YEARS OF
FOLLOW-UP.
ARE WE GOING TO SAY IT'S IN THE
PATIENT'S BEST INTEREST TO HAVE
15 YEARS OF FOLLOW-UP IN THIS
CASE OR WHAT?
>> I'LL THINK ABOUT WHAT I CAN
DO TO PUT THAT IN THERE IN A WAY
THAT'S REASONABLE.
>> ARE YOU THINKING LIKE MAYBE
ONE IDEA IS -- THE FOCUS HERE IS
ON INDIVIDUAL INTERESTS,
INDIVIDUAL BENEFIT, OR NOT
NECESSARILY STUDY BENEFIT?
OR YOU'RE OKAY WITH A MIXTURE OF
BOTH?
>> I'M OKAY WITH A MIXTURE OF
BOTH IN THEORY, PARTICULARLY IF
IT'S A RARE POPULATION ONLY A
FEW PEOPLE HAVE BEEN EXPOSED TO
THE WHATEVER, I THINK IT WOULD
BE A SHAME TO LOSE THAT
OPPORTUNITY TO LEARN ABOUT IT.
BUT IF YOU'RE JUST TALKING
PRAGMATICALLY AND THINGS ARE
BEING CLOSED DOWN BECAUSE OF
MONEY OR WHAT HAVE YOU, I JUST
DON'T SEE HOW THERE'S GOING TO
BE RESOURCES TO DO THAT.
I THINK NEEDS TO BE A BALANCE,
FIRST OFF WE'RE INTERESTED IN
THE SUBJECT'S SAFETY, AND SECOND
ALSO IF IT'S POSSIBLE TO GET
MORE SAFETY DATA FOR
POPULATIONAL USE, GREAT.
BUT THAT'S NOT OUR PRIMARY
CONCERN AT THIS MOMENT.
ALTHOUGH IT WOULD BE WONDERFUL
TO GET IT IF WE COULD.
>> I'LL THINK ABOUT IT WHEN THE
NEXT DOCUMENT IS BEING
PRESENTED.
IT ALSO MAY BE SOMETHING THAT IF
WE WANT TO COMMENT ON THE NOTION
THAT THERE'S SORT OF ADDITIONAL
SCIENTIFIC DATA BUT THEN THERE'S
SPECIFIC SAFETY DATA THAT IT
MIGHT EITHER WORK AS GOING INTO
THE PARAGRAPH AS A FOOTNOTE.
I'LL PLAY AROUND WITH THAT.
I THINK IT'S AN IMPORTANT THING
TO DISTINGUISH.
YEAH.
>> THIS IS TO WALK OFF A PLANK
NO ONE NEEDS TO WALK OFF OF SO
I'LL JUST SAY IT AND LIKE RUN
AWAY.
WHEN WE TALK ABOUT PATIENT'S
BEST INTEREST COULD BE
PSYCHOLOGICAL, ET CETERA, THERE
ARE PEOPLE WHO PARTICIPATE IN
TRIALS KNOWING THAT THEY ARE NOT
GOING TO HAVE ANY DIRECT BENEFIT
WHATSOEVER AND THEY ARE TRYING
TO ADVANCE THE KNOWLEDGE IN THIS
PARTICULAR AREA.
SO IF WE SAY, YOU KNOW, HEY, YOU
CAN CONTINUE BUT WE'RE NOT
COLLECTING ANY DATA, YOU KNOW,
THAT'S NOT GOING TO ADVANCE
THEIR BEST INTEREST AT ALL.
OR AT LEAST NOT ADVANCE WHAT WAS
THEIR MAIN INTEREST IN
PARTICIPATING IN THE TRIAL.
I'M NOW RUNNING BACKWARDS OFF
THAT PLANK.
I DON'T THINK WE NEED TO TALK
ABOUT THAT BUT --
>> ALL RIGHT. THERE WERE
ADDITIONAL SCENARIOS ALSO
PROPOSED.
FIRST, DEVICE INVESTIGATIONS
WHERE EXPLANTING OR REMOVING
POSES MORE RISK THAN CONTINUING
THE RESEARCH.
KEVIN?
>> DAVE, IN THAT PARAGRAPH THERE
THREE CASES WHERE YOU MEAN
EXPLANTATION BUT IT'S
EXPLANATION.
>> OH, THANK YOU, SPELLCHECKER.
YES, I THINK YOU'RE RIGHT.
I'LL FIX THOSE.
I REMEMBER THE SPELLCHECKER
DIDN'T LIKE THAT WORD NOW.
I MUST HAVE -- YEAH, WHEN I WENT
THROUGH ACCEPTING CHANGES I MUST
HAVE LET IT FIX A FEW OF THOSE.
>> YOU CAN PUT EXPLANT IF YOU
WANT.
I'M NOT SURE EXPLANTATION IS --
IF YOU SAID HIGH RISK EXPLANT
PROCEDURE THAT MIGHT BE -- I
DON'T KNOW.
THAT'S THE WAY WE SAY IT BUT I
DON'T KNOW IF IT'S -- I DON'T
KNOW IF THE "ATION" IS IMPORTANT
OR NOT.
I DEFER TO OTHERS.
THE OTHER THING ON 184, SUCH AS
BEHAVIORAL OR EDUCATIONAL
RESEARCH, I THINK WHAT YOU MEAN
IS THAT NON-BIOMEDICAL TRIAL
SCENARIOS.
TECHNICALLY MANY OF THOSE MIGHT
BE CLINICAL TRIALS AND CLINICAL
RESEARCH BUT NOT BIOMEDICAL.
>> RIGHT.
>> AGAIN, JUST TO PREVENT
CONFUSION.
>> IN GENERAL THE OTHER
SCENARIOS HAVE NOT REALLY
CHANGED A LOT SINCE YOU SAW THEM
SO I DON'T HAVE ANY BIG THINGS
TO POINT OUT WHERE WE HAD
CHALLENGES AT THE SUBCOMMITTEE
LEVEL.
I THINK SINCE THE LAST TIME YOU
SAW THIS THAT THE LAST ONE I
BELIEVE YOU ALL ASKED TO HAVE IT
ADDED I BELIEVE AT THE LAST
MEETING, THAT'S JUST DEALING
WITH THE FWA SORT OF
ORGANIZATION-WIDE SUSPENSION AND
CONSIDERATIONS THERE.
BUT OTHERWISE THIS IS THE END OF
THE DOCUMENTS.
WE'RE MAKING PRETTY GOOD TIME.
IF PEOPLE WANT TO BOW BACK -- GO
BACK TO A CERTAIN SECTION, WE
CAN.
I'M ALSO HAPPY TO TURN THE
AGENDA BACK OVER TO DOUG AND
START WORKING ON TRYING TO CLEAN
UP SOME OF THE -- IT WILL GIVE
US TIME TO THINK THROUGH OFFLINE
SO I DEFER TO DOUG.
MINDY, DID YOU HAVE A QUESTION?
>> YEAH, JUST ON NUMBER 3, BACK
ON LINE 210, WHICH MAY HAVE
CHANGED A LITTLE BIT.
DO WE WANT TO SAY IMPACT OF
LOSING PHYSICAL ACCESS?
I DON'T LIKE PHYSICAL.
IMPACT OF LOSING ACCESS, LET'S
SAY SOMEONE'S RECEIVING LIKE
ONLINE COUNSELING OR SOMETHING.
AND THEN THE NEGATIVE IMPACT OF
LOSING THAT RELATIONSHIP OR
WHATEVER, DOES IT HAVE TO BE
PHYSICAL?
LIKE TELEMEDICINE OR SOMETHING
LIKE THAT?
WOULD YOU GUYS CONSIDER THAT TO
BE PHYSICAL ACCESS?
>> I COULD JUST GET RID OF
PHYSICAL, I SUPPOSE.
I DON'T KNOW THAT THAT CREATES
ANY PROBLEM
>> I JUST THOUGHT IT WAS
LIMITING.
THAT'S ALL.
THANK YOU.
>> ANYTHING ELSE ANYBODY WOULD
LIKE TO ADD HERE BEFORE WE CLEAN
THIS UP AND BRING IT BACK IN A
COUPLE HOURS?
IF YOU HAVE ANYTHING, NOW IS THE
BEST TIME TO GET IT IN THERE.
>> I DO APPRECIATE ALL THE FEED
BANK.
IT'S BEEN HELPFUL.
AND I SHOULD GIVE A SHOUT OUT TO
THE SUBCOMMITTEE MEMBERS WHO PUT
QUITE A BIT OF TIME GOING INTO
THIS DOCUMENT, MANY TIMES.
SO GLAD TO SEE IT'S MAKING
PROGRESS.
>> OKAY.
WE'LL PLAN ON COMING BACK TO
THIS LATER THIS AFTERNOON.
WE STILL HAVE A FEW MINUTES
BEFORE A SCHEDULED BREAK.
I WONDER, YVONNE, WOULD YOU BE
READY TO DO YOUR EDUCATIONAL
UPDATE.
>> YES, I CAN DO THAT.
LET ME GET MY VIDEO ON.
THANK YOU FOR THE OPPORTUNITY.
>> THIS WAS NOT ON THE AGENDA
BUT WE USUALLY DO GET AN UPDATE
ON EDUCATION FROM OHRP, AND THIS
SEEMS LIKE A GOOD TIME TO PUT
THAT IN SO WE CAN HAVE A CLEAN
BREAK AND THEN COME BACK TO A
NEW TOPIC AFTER THE BREAK.
YVONNE LAU FROM OHRP IS GOING TO
SHARE A FEW THINGS WITH US.
>> I HOPE YOU CAN SEE THE
SCREEN.
I'M YVONNE LAU, DIRECTOR FOR
DIVISION OF EDUCATION AND
DEVELOPMENT AT OHRP.
I JUST WANT TO SHARE WITH YOU A
COUPLE ANNOUNCEMENTS FROM OHRP.
FIRST OF ALL IT IS A SAVE THE
DATE, ON JULY 12, FRIDAY, AT
AROUND NOONTIME AN EVENT TO
COMMEMORATE THE 50th
ANNIVERSARY OF THE NATIONAL
RESEARCH ACT.
THIS WILL BE A 2.5 HOUR VIRTUAL
EVENT PEOPLE CAN LIVESTREAM, AND
PEOPLE CAN WATCH FROM LAPTOP.
THIS EVENT IS TO COMMEMORATE THE
50th ANNIVERSARY, DIVIDED INTO
THREE SEGMENTS.
FIRST SEGMENT WILL BE REFLECTION
ON WHAT HAPPENED RIGHT AFTER THE
NATIONAL RESEARCH ACT WAS
ENACTED, SO A BIT OF HISTORY.
AND THE MIDDLE SEGMENT IS TO
SHOWCASE WHAT RESEARCH IS -- HOW
RESEARCH IS BEING DONE TODAY,
PARTICULARLY GO OFF SHOWCASING
HOW, YOU KNOW, RESEARCH SUBJECTS
ARE NOT SO MUCH SUBJECTS ANYMORE
AND THEY NOW ACTUALLY TAKE ON
MORE OF A ROLE OF PARTNER IN
RESEARCH, SO WE'RE TRYING TO USE
THIS SEGMENT TO SHOWCASE ROLES
THAT RESEARCH PARTICIPANTS ARE
NOW TAKING.
AND THEN THE THIRD SEGMENT IS
PROJECTION INTO THE FUTURE, SO
LOOKING INTO THE NEXT 10, 20
YEARS THE CHALLENGES THAT WE'LL
BE SEEING FROM THE NEW
BIOTECHNOLOGIES THAT WILL BE
COMING OUR WAY, AND THAT WILL BE
USED IN HEALTH RESEARCH, THE
OTHER THING IS ALSO THE QUESTION
OF PUBLIC TRUST.
SO PLEASE SAVE THE DATE.
PUT IT ON YOUR CALENDAR.
THIS IS WILL BE AN EVENT OHRP
WILL BE PUTTING UP.
LET ME MOVE MY SLIDES.
NEXT IS I WANT TO JUST REMIND
EVERYBODY THAT OHRP HAS ACTUALLY
RELEASED A NEW INTERACTIVE
TRAINING PROGRAM, IT'S CALLED
PARTICIPANT CENTERED INFORMED
CONSENT TRAINING.
THIS IS THE OHRP WEBSITE.
AT THE TOP YOU SEE EDUCATION AND
OUTREACH.
ON THE SIDE NAVIGATION BAR, YOU
SEE HUMAN RESEARCH PROTECTION
TRAINING.
THIS IS AN OPPORTUNITY FOR ME TO
REMIND YOU ALL THAT OHRP HAS NOW
GOT A FAIRLY COMPREHENSIVE
PROGRAM ON PROVIDING A TRAINING
ON VARIOUS ASPECTS OF ETHICS AND
REGULATIONS FOR HUMAN SUBJECTS
RESEARCH.
THERE ARE SEVERAL PARTS IN THIS
PARTICULAR PROGRAM.
AND THEN ONE OF THEM NOW IS THE
PARTICIPANT-CENTERED INFORMED
CONSENT TRAINING.
SO IF YOU CLICK ON THAT PAGE
THIS IS WHAT YOU SEE.
IT IS AN INTERACTIVE TRAINING
PROGRAM.
THERE ARE SIX MODULES TO IT.
WE CALL IT PARTICIPANT CENTERED
BECAUSE IT IS WHAT THE GOAL OF
THIS IS.
TRYING TO PROVIDE INFORMATION OF
WHAT IT MEANS BY BEING -- BY
DOING A PARTICIPANT-CENTERED --
CREATING PARTICIPANT-CENTERED
CONSENT FORM.
WE RECOMMEND PEOPLE ACTUALLY
OPEN UP THE PAGE TO VIEW THE
ENTIRE PROGRAM IN ITS FULL
FORMAT.
THERE ARE SIX MODULES TO THIS
TRAINING PROGRAM, AND IT'S EASY
ENOUGH TO NAVIGATE.
ONCE YOU'RE IN IT, YOU'LL SEE
THE WELCOMING PAGE.
ON THIS SLIDE IF YOU CAN SEE THE
MENU, AND IT'S JUST NAVIGATION,
THERE'S SIX MODULES, MODULE 1 IS
HOW WE CAN IMPROVE CONSENT
FORMS, TALKS ABOUT ETHICS,
BACKGROUND OF THE REGULATIONS,
MODULE 2 IS ABOUT WHAT THE
PARTICIPANT-CENTERED APPROACH
MEANS.
WE TALK ABOUT PROVIDING
CONTEXTUAL INFORMATION TO HELP
PARTICIPANTS, POTENTIAL
PARTICIPANTS UNDERSTAND THE
INFORMATION THAT THEY ARE
RECEIVING ABOUT THE RESEARCH.
MODULE 3, 4, HOW TO WRITE THESE
CONSENT FORMS USING WORDS,
PAYING ATTENTION TO READABILITY.
MODULE 4 HOW TO ORGANIZE CONSENT
FORM INFORMATION SO THERE'S A
COHERENT NARRATIVE AND NOT
PIECES OF INFORMATION ALL OVER
THE PLACE.
THERE IS ALSO A SEGMENT WHERE WE
MENTION A LITTLE BIT ABOUT KEY
INFORMATION, AND PROVIDE
POSSIBLE EXAMPLE OF WHAT THAT
MAY LOOK LIKE.
AND THEN MODULE 5 IS HOW TO
DESIGN AND FORMAT AND DISPLAY
THE INFORMATION AND FINALLY
MODULE 6 IS A RECAP OF THE
TRAINING.
THERE ALSO -- I WANT TO DRAW
YOUR ATTENTION TO THE RESOURCE
TAB AT THE TOP WHERE IT WOULD BE
VERY EASY TO ACCESS CERTAIN
DOCUMENTS THAT PROVIDE, FOR
EXAMPLE, LIST OF COMMONLY USED
WORDS IN PLAIN LANGUAGE, THAT
RESEARCHERS CAN OPT TO USE
INSTEAD OF COMPLICATED MEDICAL
TERMS.
THERE'S ALSO A -- WE PROVIDED
WHAT A KEY INFORMATION SECTION
MIGHT LOOK LIKE FOR CONSENT
FORM, SOMETHING YOU CAN ALSO
ACCESS FROM THE RESOURCE TAB.
SO WITH THAT, I HOPE THAT
EVERYBODY WILL TRY AND PLAY WITH
THIS PROGRAM A LITTLE BIT AND
ENCOURAGE INVESTIGATORS AND
INSTITUTIONS, TRIAL COORDINATORS
TO TAKE A LOOK AT THIS TRAINING
AND HOPEFULLY YOU'LL FIND THIS
TRAINING TO BE HELPFUL.
THANK YOU SO MUCH.
>> THANK YOU, YVONNE.
THAT WAS VERY HELPFUL.
WELL, WE'RE ABOUT 15 MINUTES
AHEAD.
IT SEEMS RATHER THAN DOING 15
MINUTES OF OUR NEXT TOPIC, IT
SEEMS TO MAKE SENSE TO DO AN
EARLY BREAK IF THAT'S OKAY WITH
EVERYBODY.
SO, WHY DON'T WE TAKE A
30-MINUTE BREAK, WHICH MEANS
BEING BACK HERE AT ABOUT 10:15.
SHARP.
WE'LL TAKE UP OUR SECOND TOPIC
OF THE MORNING.
>> OR 1:15 FOR THOSE --
>> YEAH, SORRY.
>> WE'RE BACK AT 1:15.
EVERYBODY PLEASE BE BACK AND
READY TO GO AT 1:15.
ALL RIGHT?
TERRIFIC.
THANK YOU SO MUCH.
WELCOME BACK.
WE'RE GOING TO TURN THIS OVER TO
LINDA COLEMAN, SUBPART A
COMMITTEE CO-CHAIR, AND SHE'S
GOING TO LEAD US THROUGH OUR
SECOND MAJOR AGENDA ITEM, WHICH
IS THE ETHICAL AND REGULATORY
CONSIDERATIONS FOR THE INCLUSION
OF LGBTQI+ POPULATIONS IN HAST
HUMAN SUBJECTS RESEARCH.
THIS STATEMENT IS NOT AS FAR
ALONG AS THE BEST INTEREST
STATEMENT BUT I WOULD HOPE
WE CAN GIVE LINDA AND
SUBCOMMITTEE ENOUGH GUIDANCE.
>> THANK YOU, DOUG.
SO, AS DOUG MENTIONED, WE'RE
GOING TO FOCUS ON THE
RECOMMENDATIONS FOR THE ETHICAL
REVIEW AND INCLUSION OF LGBTQI+
PARTICIPANTS IN HUMAN SUBJECTS
RESEARCH.
WANT TO THANK SUBCOMMITTEE
MEMBERS FOR WORK ON THIS CHARGE
DOCUMENT, THIS IS NOT THE
RECOMMENDATION DOCUMENT, THIS IS
JUST A CHARGE.
AND I ALSO WANTED TO ACKNOWLEDGE
OUR WORKING GROUP MEMBERS,
LESLIE WOLF, CHERYL, COURTNEY,
MINDY, AND DAVID WHO WILL BE
ASSISTING THE SUBCOMMITTEE AND
THIS GROUP GETTING THE
RECOMMENDATIONS FINALIZED.
AS I MENTIONED, WHAT I DID WAS
PUT TOGETHER -- YOU HAVE THE
DOCUMENT IN FRONT OF YOU, YOU DO
HAVE THE DOCUMENT.
I THOUGHT IT WOULD BE HELPFUL TO
WALK THROUGH THE ENTIRE DOCUMENT
FIRST AND THEN GO BACK SO THAT
WE CAN THEN GET YOUR THOUGHTS.
I PUT THIS INTO A POWERPOINT TO
BE EASIER.
I'M GOING TO SHARE MY SCREEN.
CAN YOU SEE THAT?
>> YES.
>> I CAN SEE YOU, I NEED TO BE
ABLE TO DO THAT.
OKAY, PERFECT.
OKAY.
SO, I THINK THE FIRST PART OF
THE INTRODUCTION WE ALL KNOW
WHAT THIS CHARGE -- WHAT THE
FOCUS IS IN REGARD TO THIS
CHARGE.
THE ONE THING I WANTED TO CALL
OUT THOUGH IS THAT WHEN WE'RE
CONSIDERING RECOMMENDATIONS,
THAT WE'RE INCLUDING ADULT AND
MINOR PARTICIPANTS.
I THINK THAT'S IMPORTANT PART.
I ALSO -- WHAT'S NOT IN THE
CHARGE BUT I WANTED TO MENTION
WE WERE TALKING ABOUT LGBTQI+
PARTICIPANTS IN GENERAL, THERE'S
LIKE THREE CATEGORIES THAT YOU
COULD PROBABLY THINK ABOUT.
SO, THE FIRST CATEGORY WOULD BE
RESEARCH WHERE SOMEONE FROM ONE
OF THESE COMMUNITIES
PARTICIPATES IN A RESEARCH
STUDY.
BUT THE RESEARCH IS NOT FOCUSED
ON LGBTQI+ RESEARCH QUESTIONS.
THAT MIGHT BE ONE CATEGORY.
ANOTHER CATEGORY MIGHT BE
RESEARCH THAT FOCUSES ON
SPECIFIC LGBTQI+ RESEARCH
QUESTIONS THEMSELVES.
THIRD MIGHT BE A SITUATION WHERE
ONE OR MORE OF THESE COMMUNITIES
MIGHT HAVE A RESEARCH QUESTION
OR AN AREA THAT MIGHT BE OF
PARTICULAR INTEREST TO THEM.
FOR EXAMPLE, ONTOLOGY, MENTAL
HEALTH, ANOTHER AREA WHERE
THERE'S RESEARCH THAT'S
OCCURRING WHERE OTHER
INDIVIDUALS MIGHT BE INCLUDED
BUT THIS WOULD BE PARTICULAR
INTEREST POTENTIALLY FOR SOMEONE
FROM ONE OF THESE COMMUNITIES.
IN TERMS OF MOTIVATION, BY THREE
OBJECTIVES, TO ENSURE ETHICAL
PROTECTION OF LGBTQI+
PARTICIPANTS INVOLVED IN
RESEARCH, OF COURSE ALIGNING
WITH APPLICABLE REGULATIONS, TO
ADVANCE RESEARCH AND REDUCE
HEALTH DISPARITIES AND
CONTRIBUTE TO ADVANCEMENT OF
KNOWLEDGE AND CULTURAL
AWARENESS.
ANOTHER COUPLE POINTS TO CALL
OUT IN TERMS OF THE SCOPE OF THE
DOCUMENT IT'S NOT JUST FOCUSED
ON IRBs.
I THINK IT IS FOCUSED ON ALL
STAKEHOLDERS, A NUMBER OF
STAKEHOLDERS INCLUDING
INVESTIGATORS, SPONSORS, IRBs,
RESEARCH INSTITUTIONS, AND MIGHT
BE OTHERS THAT WE MIGHT WANT TO
CALL OUT.
AGAIN, I ALREADY TALKED ABOUT
THE FACT WE'RE CONSIDERING ADULT
AND MINOR PARTICIPANTS, AND I
THINK ONE IMPORTANT COMMENT,
THIS IS NOT JUST ONE GROUP.
THIS REPRESENTS DISTINCT
COMMUNITIES, EACH WITH ITS OWN
SET OF SENSITIVITIES, HEALTH
DISPARITY, POTENTIAL HEALTH
DISPARITIES, AND SPECIFIC
RESEARCH NEEDS.
AGAIN, IT'S NOT A
ONE-SIZE-FITS-ALL.
IT'S REALLY IMPORTANT THAT WE
KEEP THAT POINT IN MIND.
QUESTIONS FOR CONSIDERATION,
IT'S DIVIDED INTO THREE MAIN
SECTIONS.
THE REASON FOR THAT BEING THAT
AS WE'RE DEVELOPING OR WRITING
THE RECOMMENDATIONS, IT MIGHT BE
A USEFUL SORT OF FRAMEWORK FOR
HOW WE WRITE THE DOCUMENT
ITSELF.
OF COURSE, AS WE DELVE INTO THIS
A BIT MORE WE MAY DECIDE YOU AS
A SACHRP COMMITTEE MAY DECIDE TO
REORDER SOME OF THESE THINGS OR
MIGHT LOOK DIFFERENT BUT I THINK
FOR THE PURPOSES OF THE CHARGE
AND STARTING THIS CONVERSATION
THERE'S THREE MAIN SECTIONS.
FIRST IS MORE OVERARCHING,
LEGAL, REGULATORY, ETHICAL
CONSIDERATION WHICH MAKES SENSE,
YOU WANT TO START WITH THAT.
SECOND IS FOCUSING MORE ON HOW
TO ESTABLISH INCLUSIVE AND
CULTURALLY SENSITIVE RESEARCH
ENVIRONMENT AS A WHOLE TO FOSTER
THIS RESEARCH.
THIRD GETS INTO CONSIDERATIONS
SPECIFIC TO DESIGN, REVIEW,
CONDUCT, DISSEMINATION OF
RESULTS IN TERMS OF RESEARCH.
SO THE ENTIRE RESEARCH LIFE
CYCLE.
SO THE FIRST QUESTION, FIRST
SECTION, THERE ARE TWO QUESTIONS
THAT WERE ASKED.
THIS IS A LEGAL, REGULATORY,
ETHICAL CONSIDERATIONS.
AGAIN, THE FIRST QUESTION IS
FAIRLY HIGH LEVEL IN TERMS OF
HOW DO WE SEEK TO ENSURE
ADEQUATE INCLUSION OF LGBTQI+
PARTICIPANTS, PROTECTING THEIR
RIGHTS AND WELFARE, AND THEN
SECOND QUESTION FOCUSES A LOT ON
THE ISSUES RELATED TO
COMPLEXITIES OF APPLICABLE LAWS,
REGULATIONS, GUIDELINES,
DIRECTIVES, STANDARDS.
A LOT OF THIS, THERE'S A LOT
HERE THAT I'M ASSUMING YOU'LL
HAVE COMMENTS ON, BECAUSE
WE'RE -- BECAUSE OF ISSUES
RELATED TO THINGS LIKE DIFFERENT
VIEWPOINTS ON THIS TOPIC,
POLITICAL AND SOCIAL
DETERMINANTS OF HEALTH, AND THE
FACT THAT WHEN YOU'RE LOOKING AT
HE'S REGULATIONS AND GUIDELINES,
DIRECTIVES AND STANDARDS IT'S
NOT JUST 45 CFR 46 REGULATIONS,
THERE'S SO MUCH TO CONSIDER WHEN
CONDUCTING RESEARCH WHETHER YOU
ARE DOING RESEARCH AT ONE SITE
OR DOING MULTIPLE SITE RESEARCH,
THERE'S A LOT OF COMPLEXITY HERE
IN TERMS OF HOW TO NAVIGATE SOME
OF THE ISSUES IN REGARD TO WHAT
WE'RE GOING TO BE TALKING ABOUT
TODAY.
THE SECOND BUCKET WOULD BE THIS
ISSUE OF ESTABLISHING INCLUSIVE
AND CULTURALLY SENSITIVE
RESEARCH ENVIRONMENT, SO, AGAIN,
THIS GETS INTO WHAT CAN WE DO TO
SEEK TO ENSURE THAT WE ARE
ACTIVELY OR IN A MEANINGFUL WAY
ENGAGING WITH COMMUNITY, WHAT
DOES THAT LOOK LIKE, YOU KNOW,
HOW DO WE DO THIS?
HOW DO YOU INCORPORATE THIS
THROUGHOUT THE LIFE CYCLE OF A
STUDY, YOU KNOW, WHAT'S
APPROPRIATE CALIBRATION FOR THIS
THIS, ET CETERA.
SO THAT'S WHAT THIS HAS TO DO
WITH.
AND THEN IN TERMS OF
COMPOSITION, I THINK WE'VE -- A
LOT OF TIMES WE FOCUS ON THE
IRB, BUT I THINK THE
SUBCOMMITTEE FELT IMPORTANT,
FELT IT WAS IMPORTANT TO ALSO
INCLUDE OTHER STAKEHOLDERS SUCH
AS STUDY TEAM, ORGANIZATIONAL
LEADERSHIP, IN TERMS OF HOW DO
WE PROMOTE DIVERSE AND INCLUSIVE
REPRESENTATION DURING THE
RESEARCH PROCESS.
AND THEN THE THIRD TOPIC OR
THIRD QUESTION OR AREA HAS TO DO
WITH CULTURAL COMPETENCE, AND
THIS GETS INTO ISSUES OF
CULTURAL AWARENESS, CULTURAL
COMPETENCE, CULTURAL HUMILITY.
FOR EXAMPLE WHEN WE'RE TALKING
ABOUT THESE TYPES OF ISSUES FOR
EXAMPLE IT WOULD BE SOMETHING
LIKE WHAT TYPE OF MAYBE
EDUCATION AND TRAINING MIGHT BE
NECESSARY ACROSS, YOU KNOW,
VARIOUS -- IN TERMS OF VARIOUS
STAKEHOLDERS IN THE RESEARCH
PROCESS, HOW DO WE INCLUDE
SEXUAL ORIENTATION AND GENDER
IDENTITY OPTIONS WHEN THINKING
ABOUT RESEARCH, HOW DO YOU MAKE
YOUR ENVIRONMENT MORE LGBTQI+
FRIENDLY.
THERE'S A LOT OF LITERATURE ON
THE TOPIC, AND I WOULD IMAGINE
THERE WOULD BE A LOT OF
CONVERSATION WHAT DOES THIS MEAN
AND HOW DO WE ACTUALLY
ACCOMPLISH THIS.
SO, THAT'S WHAT THIS QUESTION IS
ABOUT.
AND THEN THE ISSUE OF
INTERSECTIONALITY, THIS REALLY
GETS TO THE FACT THAT WHEN
THINKING ABOUT LGBTQ+
PARTICIPANTS, THAT THERE ARE
OTHER CHARACTERISTICS AND, YOU
KNOW, OTHER ISSUES THAT WE NEED
TO.
RACE, ETHNICITY, THIS IS WHAT
INTERSECTIONALITY COMES INTO
PLAY.
HOW ARE WE GOING TO ADDRESS
THAT?
THE THIRD AREA HAS TO DO WITH
THE DESIGN, REVIEW, CONDUCT,
DISSEMINATION OF RESULTS.
AGAIN, THE FIRST ONE IS REALLY
ABOUT HOW DO WE DESIGN AND
ANALYZE RESEARCH, GETS INTO WHAT
ARE THE RESEARCH QUESTIONS,
METHODS, HOW RESEARCH IS BEING
CONDUCTED, INCLUSION/EXCLUSION
CRITERIA, THE COLLECTION
ANALYSIS OF SEXUAL ORIENTATION
AND GENDER IDENTITY DATA, AND
THOSE TYPES OF ISSUES.
AND THEN ACCESS AND INCLUSION.
AGAIN, WHAT STRATEGIES TO BE
EMPLOYED IN THE DEVELOPMENT,
EVALUATION OF RECRUITMENT PLANS,
FOR EXAMPLE, FOR LGBTQI+
PARTICIPANTS TO PROMOTE
RESEARCH, THERE'S MORE WE CAN
ADD HERE BUT THAT'S ONE OF THE
QUESTIONS THAT WAS INCLUDED.
INFORMED CONSENT GETS TO THE
ISSUE OF THE PROCESS, NEEDS AND
INTERESTS OF COMMUNITIES, THAT
GETS TO WHAT TERMINOLOGY IS
BEING USED, TYING INTO OTHER
ISSUES SUCH AS CULTURAL
SENSITIVITY ISSUES WE TALKED
ABOUT AND HOW DOES THAT PROCESS
LOOK.
PRIVACY AND CONFIDENTIALITY,
STIGMA FOR HARM, OTHER ISSUES
THAT COULD BE CONSIDERED, AND,
AGAIN, HERE WE ADDED INCLUDING
NOT JUST THE LGBTQI+ RESEARCH
PARTICIPANTS THEMSELVES BUT ALSO
POTENTIALLY NON-RESEARCH --
NON-SUBJECTS, FOR EXAMPLE, AS
YOU KNOW THERE WAS A
RECOMMENDATIONS WRITTEN A COUPLE
YEARS AGO THAT TOUCHED UPON THE
ISSUE OF RISK TO NON-RESEARCH
PARTICIPANTS, AND SO THERE'S
SOME -- THERE'S PROBABLY SOME
RECOMMENDATIONS OR GUIDANCE
THERE WE CAN DRAW UPON AS WELL.
AND THEN OVERSIGHT SUPPORT AND
SECURITY, THIS GETS TO THE ISSUE
OF WHAT DO, YOU KNOW,
INVESTIGATORS, SPONSORS, IRBs
AND RESEARCH INSTITUTIONS NEED
TO DO TO ENSURE APPROPRIATE
OVERSIGHT, INFRASTRUCTURE,
SECURITY AND OTHER SUPPORT FOR
THIS TYPE OF RESEARCH.
AND THEN THE FINAL QUESTION
RELATES TO REPORTING AND
DISSEMINATION OF FINDINGS.
SO, AGAIN, HERE IS WHEN YOU ARE
REPORTING.
THIS IS A TOPIC IN THE RESEARCH
COMMUNITY WE'VE BEEN TALKING
ABOUT, WHEN IS IT APPROPRIATE.
THE IF, WHEN, AND HOW TO REPORT
AND DISSEMINATE FINDINGS.
SO THIS REALLY IS FOCUSED ON
THAT ISSUE SO WHEN YOU ARE
REPORTING AND DISSEMINATING
FINDINGS HOW SHOULD
INVESTIGATORS, SPONSORS, IRBs
AND RESEARCH INSTITUTIONS SEEK
TO ENSURE THAT THE FINDINGS FROM
RESEARCH ARE REPORTED AND
DISSEMINATED IN A WAY THAT
PROMOTES TRANSPARENCY BECAUSE
THAT CAN BUILD TRUST
POTENTIALLY.
THE ISSUE OF COMMUNITY BENEFIT.
ALSO PREVENT MISREPRESENTATION
OR MISINFORMATION AS WELL AS
INDIVIDUAL OR INDIVIDUAL AND
COMMUNITY GROUP HARM.
THAT IS THE CHARGE DOCUMENT.
AND SO WHAT I WANT TO DO NOW IS
GO BACK TO MAYBE PAST THE
INTRODUCTION AND SORT OF FOCUS
NOW ON THE FIRST SECTION.
AND GET YOUR COMMENTS.
I'M THINKING WHAT'S GOING TO
HAPPEN HERE, WE'LL TAKE YOUR
COMMENTS AND DO OUR FIRST DRAFT
OF THE RECOMMENDATIONS.
THE PURPOSE IS TO WALK THROUGH
EACH OF THE QUESTIONS AND TO GET
YOUR -- MAYBE YOU MIGHT WANT TO
CLARIFY A FEW POINTS.
IF THERE ARE QUESTIONS ABOUT
WHAT IS BEING ASKED, BUT ALSO TO
GET YOUR FEEDBACK, EXAMPLES YOU
MIGHT WANT INCLUDED.
THIS IS AN OPEN CONVERSATION TO
HELP SHAPE THE FIRST DRAFT AND
FUTURE DRAFTS OF THE
RECOMMENDATION DOCUMENT.
SO I'LL STOP THERE AND THEN I'LL
MOVE ON TO SEE IF SOMEBODY WANTS
TO START WITH A COMMENT.
TWO HANDS UP.
I'LL START WITH SANDRA.
>> NO, I'M PROBABLY PREEMPTING
YOUR MOVEMENT TO THE FIRST
SECTION.
BUT I WANTED TO -- I UNDERSTAND
STARTING OFF IN THIS WAY, WHERE
LEGAL, REGULATORY AND ETHICAL
CONSIDERATIONS ARE INTRODUCING
THE CHARGE.
I DO THINK THAT THE ETHICAL
CONSIDERATIONS OF COURSE ARE
GOING TO RUN THROUGH THE ENTIRE
DOCUMENT, PARTICULARLY WITH
RESPECT TO, YOU KNOW,
CONSIDERATIONS AROUND DESIGN,
REVIEW, YOU KNOW, THE INCLUSION
OF STAKEHOLDERS IN TERMS OF, YOU
KNOW, HOW THEY ARE INCLUDED, HOW
THE RESEARCH IS BEING REPORTED.
SO, THIS IS JUST TO SAY YOU'RE
PROBABLY PLANNING TO DO THAT
ALREADY, BUT I WOULD HIGHLY
RECOMMEND THAT WE CALL OUT THE
ETHICAL CONSIDERATIONS
THROUGHOUT.
>> THANK YOU.
DOES ANYBODY ELSE WANT TO START?
WE DON'T HAVE TO START AT THE
FIRST QUESTION.
WE CAN START ANYWHERE YOU WOULD
LIKE AND THAT WILL GET THE
CONVERSATION GOING.
LOIS?
>> I WAS LOOKING AT THE -- SO I
THINK I MISUNDERSTOOD WHAT WE
WERE DOING.
SO THE CHARGE HAS ALREADY BEEN
ADOPT, IS THAT RIGHT?
>> THE CHARGE HAS BEEN -- IT'S
CONSIDERED FINALIZED.
IT DOESN'T MEAN, HOWEVER, THAT
IF THERE'S ADDITIONAL THOUGHTS
WE CAN CERTAINLY TALK ABOUT IT.
I THINK THE IDEA NOW WE WANT TO
MOVE TO THE RECOMMENDATIONS SO I
THINK WE HAVE ENOUGH OF A
FRAMEWORK TO SORT OF MOVE
FORWARD.
SO AS YOU'RE LOOKING AT THESE
QUESTIONS IT DOESN'T MEAN THIS
IS THE ONLY THING YOU CAN TALK
ABOUT IN A PARTICULAR SECTION.
IT JUST MEANS THIS SORT OF
SHAPES THE CONTENT THAT YOU
MIGHT WANT TO CONSIDER IN A
PARTICULAR SECTION.
>> RIGHT.
THANK YOU.
YEAH, I HAD A COMMENT ON THE
THIRD PARAGRAPH OF THE CHARGE.
SO I'M NOT ASKING THE CHARGE BE
CHANGED OR ANYTHING LIKE THAT,
BUT THIS MIGHT BE SOMETHING
THAT'S USEFUL IF WE GO FORWARD.
I WAS A LITTLE BIT STRUCK BY
SOME PHRASING.
SO THIS ISN'T GETTING TO THE
SUBSTANCE RIGHT NOW.
KIND OF GETTING TO THE WAY WE
PHRASE THINGS.
I DON'T KNOW IF LGBTQ -- THIS IS
IN THE THIRD PARAGRAPH, LGBTQI+
PARTICIPANTS, I'D SAY THEY ARE
MEMBERS OF DISTINCT COMMUNITIES
RATHER THAN REPRESENT.
I THINK WE'RE GOING TO WANT TO
BE CAREFUL ABOUT THAT KIND OF
LANGUAGE.
THEY ARE NOT REPRESENTING A
COMMUNITY.
IN THE WAY WE THINK ABOUT
REPRESENTATION.
I WAS STRUCK WITH ITS OWN SET OF
SENSITIVITIES, THAT SOUNDED
LIKE, YOU KNOW, I LOOKED UP THE
WORD SENSITIVITIES BECAUSE IT
STRUCK ME.
IT'S LIKE THIS IDEA OF LIKE
BEING EASY TO OFFEND, AND I
DON'T THINK WE WANT TO CONVEY
THAT.
LIKE IN OUR FINAL, YOU KNOW, IN
WHATEVER RECOMMENDATIONS.
YOU KNOW, THEY MIGHT HAVE THEIR
OWN SET OF INTERESTS OR
CONCERNS, BUT SENSITIVITIES
MIGHT JUST BE NOT THE -- YEAH, A
LITTLE LOADED, MIGHT NOT BE WHAT
WE WANT GOING FORWARD.
THAT'S ALL.
>> THAT MAKES SENSE.
I THINK THE TERM REPRESENTATION,
THE WORD YOU USED IS A BETTER
WORD, THAT'S THE INTENT OF THAT
WORD.
NOT REPRESENTATION IN THE SENSE
YOU WERE THINKING BUT I AGREE.
LET'S WALK THROUGH AND TALK
ABOUT THE FIRST SECTION IN TERMS
OF-- OKAY, RUQAIIJAH?
>> YOU CAN GO AHEAD WITH YOUR
OVERVIEW FIRST, I WAS GOING TO
THE FIRST SECTION.
>> I WAS GOING TO JUMP AHEAD.
I WANTED TO FOCUS ON THE
QUESTIONS AND GET FEEDBACK ON
THAT.
BUT, AGAIN, ANY FEEDBACK IS
WELCOME, SO I WAS GOING BACK TO
THE FIRST SECTION.
WOULD YOU PREFER I USE THE
POWERPOINT TO DO THIS SO WE CAN
FOCUS ON THE QUESTION OR DO YOU
WANT ME TO PUT THE CHART?
EITHER WAY WORKS FOR ME.
>> I WAS GOING TO THE LANGUAGE
IN THE CHARGE UNDER NUMBER ONE
SPECIFICALLY.
SO THIS IS HELPFUL FOR ME.
IN REVIEWING I WOULD SUGGEST
SEPARATING OUT THE LAWS,
REGULATIONS, GUIDELINES,
DIRECTIVES, AND STANDARDS
BECAUSE THEY ARE NOT ALL ON
EQUAL FOOTING.
PARTICULARLY RELIGIOUS
DIRECTIVES, I DON'T KNOW HOW
THEY COME INTO THE DISCUSSION OF
RESEARCH, SO FOR THAT I WOULD
TALK ABOUT LAWS AND REGULATIONS,
SEPARATE GUIDELINES AND
STANDARDS, AND CUT OUT RELIGIOUS
DIRECT I WAS.
AND/OR JUST SAY DIRECT I WAS.
JUST BECAUSE LAWS AND
REGULATIONS ARE BINDING, WHEREAS
GUIDELINES, DIRECTIVES AND
STANDARDS ARE NOT.
BUT THOSE COULD COME MORE UNDER
THE REGULATORY SECTION OF IT.
>> OKAY.
SO IN THE RECOMMENDATION
DOCUMENT WE SHOULD SEPARATE
THOSE OUT IS WHAT YOU'RE
RECOMMENDING?
>> YES.
>> OKAY.
>> AND I WOULD ALMOST SAY THAT
IN THE CHARGE TOO, JUST BECAUSE
AS THIS IS COMING FROM I THINK,
OH, I DON'T KNOW WHO IT'S COMING
FROM, FROM SACHRP OR -- BUT
RELIGIOUS DIRECTIVES SHOULD NOT
BE A PART OF IT.
>> OKAY.
I WILL MAKE A NOTE THERE.
>> MAYBE YOU CAN TELL US WHAT
THE THINKING WAS WITH RESPECT TO
--
>> IT WAS THAT THERE ARE
DIRECTIVES, I SHOULD SAY, MORE
BROADLY, BUT THE CONVERSATION
DID COME UP BECAUSE WHEN WE'RE
TALKING ABOUT COMPLEXITY OF SOME
LAWS, DIFFERING VIEWPOINTS,
THOSE TYPE OF ETHICS, WHEN
YOU'RE DOING RESEARCH THERE ARE
RELIGIOUS DIRECTIVES THAT DO
IMPACT HOW WE ACTUALLY CONDUCT
OUR REVIEWS, HOW WE DO OUR
CONCEPTING,-- CONSENTING, THEY
COME INTO PLAY.
WE COULD LEAVE IT AS DIRECTIVES
MORE GENERALLY TO YOUR POINT,
RUQAIIJAH, WE DO HAVE A LOT OF
INSTITUTIONS THAT YOU HAVE TO
PAY ATTENTION TO THOSE TYPES OF
DIRECTIVES POTENTIALLY IN
CONSENTING, PROTOCOL WRITING, SO
IT WAS MORE PRACTICALLY WHAT
HAPPENS, WHAT SOME OF US HAVE TO
FACE BUT I AGREE WITH YOU,
RUQAIIJAH, WE SHOULD -- I DON'T
THINK -- FOR SURE WE CAN
SEPARATE OUT THIS BULLET TO MAKE
IT CLEAR.
WE CAN SAY DIRECTIVES.
MINDY, YOU HAD A COMMENT?
>> I WAS GOING TO SAY I'M FINE
WITH SEPARATING OUT RELIGIOUS
DIRECTIVES SOMEWHERE ELSE.
AS YOU MENTIONED, THIS IS NEAR
AND DEAR TO MY HEART BECAUSE WE
SERVE A CATHOLIC HOSPITAL WHERE
THEY WON'T EVEN ALLOW US AT THIS
TIME TO EVEN TALK ABOUT THIS
ISSUE BECAUSE OF THE RELIGIOUS
DIRECTIVES.
AND RELIGIOUS DIRECTIVES ARE
BINDING UNDER CANON, THEY ARE
BINDING.
THANK YOU.
>> THEY ARE BINDING, BUT ARE
THEY BINDING OF THE GOVERNMENT
OR MORE THE INSTITUTION?
AND THAT'S WHY I WOULD SAY MAYBE
WE SEPARATE ON -- OUT TO
INSTITUTIONAL THINGS VERSUS SORT
OF FEDERAL?
BUT, MINDY, I WOULD LOVE TO HEAR
MORE OF YOUR PERSPECTIVE ON
THAT.
OF HOW WE GEAR THIS TO THE
DIFFERENT STAKEHOLDERS WHILE
STRIKE TO MAKE IT'S CLEAR IT'S
NOT SOMETHING THE GOVERNMENT IS
DOING BUT INSTITUTIONS MAY DO.
>> SURE, I UNDERSTAND THAT TOO.
IT WOULD BE INSTITUTION.
I GET THAT.
THANK YOU.
>> GOOD.
ERIC, GO AHEAD.
>> I APPRECIATE THE DISCUSSION.
I CAN IMAGINE THE THINKING,
WANTING A BROAD APPROACH TO
THIS, BEING ALMOST TO A WIDE
AUDIENCE BUT THIS WILL BE A
GOVERNMENT DOCUMENT THAT WE
FOCUS AS RUQAIIJAH WAS SAYING ON
LAWS AND REGULATION, GUIDELINES
IN THE CONTEXT OF WHAT SACHRP IS
OFFERING AS GUIDELINES.
THIS CONCEPT OF DIRECTIVES AND
STANDARDS IS A LITTLE UNUSUAL
FROM POINT OF VIEW OF WHAT I'VE
SEEN IN OTHER REGULATORY
DOCUMENTS.
SO MAYBE WE FOCUS ONLY ON LAWS,
REGULATIONS, AND GUIDELINES, IN
THE CONTEXT OF SACHRP.
WE CAN FOOTNOTE IT BUT MAYBE
TAKE THAT APPROACH.
>> THERE MIGHT BE OTHER
INSTITUTIONAL OR OTHER LOCAL
CONSIDERATIONS THAT -- WE ALWAYS
TALK ABOUT LOCAL CONTEXT.
WE TALK ABOUT INSTITUTIONAL
POLICIES, SO WHAT YOU'RE
SUGGESTING IS EITHER NOT
INCLUDING IT AT ALL OR JUST
HAVING A DIFFERENT SECTION, I
WANT TO CLARIFY WHAT YOU'RE
RECOMMENDING.
>> YEAH, WONDERING IF YOU
LABELED THIS SECTION LAWS,
REGULATIONS, AND GUIDELINES.
>> OKAY.
>> DIRECTIVES AND STANDARDS, THE
GUIDELINE MIGHT BE EVENTUALLY
INDIVIDUAL INSTITUTIONS MAY NEED
TO APPLY LOCAL CONSIDERATION,
THAT MAY BE THE GUIDELINE BUT
THE IDEA OF DIRECTIVES AND
STANDARDS IS LESS COMMON
THINKING ABOUT REGULATORY TEXT
AND GUIDANCE OHRP PUT OUT FOR
EXAMPLE.
>> THAT MAKES SENSE.
I'M NOT SURE WHO WAS UP NEXT.
I'LL GO WITH ALLISON AND KEVIN.
>> I'M NOT ON THIS POINT.
KEVIN, ARE YOU ON THIS POINT?
>> YEAH.
I'LL BE FAST.
THANKS, ALLISON.
I THINK I AGREE WITH ERIC.
IT WOULD BE CLEANER AND
COMPLEMENT ETHICAL
CONSIDERATIONS ABOVE.
BUT I'M ALSO LOOKING AT THE
TEXT. THERE IT SEEMS LIKE
THERE'S SOMETHING IN THE SPIRIT
OF THAT THAT THE QUESTION ASKERS
ARE GETTING -- ACKNOWLEDGING
THESE DIVERSE VIEWPOINTS THAT
ARE OUT THERE, THIS SORT OF MESS
OF FACTORS THAT COULD CREATE
BARRIERS TO DOING THE SORTS OF
THINGS THAT WE'RE RECOMMENDING,
SO I'M WONDERING IF WE DROP THAT
PART OUT OF THIS, CAN WE JUST
TAKE THAT AS SORT OF IMPLICIT
THROUGHOUT ALL OF THESE THAT
WE'RE TRYING TO MAKE
RECOMMENDATIONS IN THE CONTEXT
OF THESE VERY DIVERSE VIEWPOINTS
AND IMPACT OF POLITICAL AND
SOCIAL DETERMINANTS.
>> OKAY.
SO, I WANTED TO -- THIS IS ALL
CLEAR, SO MY QUESTION IS I JUST
WANTED TO CONFIRM.
SO LAWS, REGULATIONS,
GUIDELINES, THAT MAKES SENSE TO
ME.
ORIGINALLY I THINK WE HAD
SOMETHING MORE SPECIFIC TO THAT,
AS IT EVOLVED WE INCLUDED SOME
OTHER THINGS.
IN TERMS OF THE ISSUES OF
POLITICAL AND SOCIAL
DETERMINANTS OF HEALTH, WHAT YOU
JUST SAID, KEVIN, ARE YOU
SUGGESTING THAT WE DON'T NEED
ANOTHER BULLET FOR THE CHARGE?
AND/OR IT'S JUST SORT OF IMPLIED
WE'LL BE TOUCHING UPON THOSE
ISSUES THROUGHOUT THE DOCUMENTS?
I THINK THAT'S WHAT YOU HEARD,
THE LATTER IS WHAT I HEARD.
>> YEAH, I DON'T KNOW WHAT THE
INTENTION WAS WITH THAT
LANGUAGE.
ONE READING THESE ARE CONTEXTUAL
ISSUES THAT ARE GOING TO BE
RELEVANT PRETTY MUCH TO
EVERYTHING THERE, AND SO IF
THAT'S CORRECT WE COULD REMOVE
IT AND JUST KNOW IT'S IMPLICIT,
MAYBE REFLECTED, BUT IF IT
MEANT SOMETHING ELSE MAYBE
THERE'S ANOTHER BULLET THAT'S
REQUIRED THEN BECAUSE THERE'S A
SPECIFIC ISSUE THAT NEEDS TO BE
ADDRESSED.
>> I THINK THE ISSUE, THE REASON
WHY IT'S ADDED, BECAUSE IT WOULD
APPEAR IN THE RECOMMENDATIONS AS
YOU'RE DOING FRAMING, THE
RECOMMENDATIONS.
YOU WOULD PROBABLY TOUCH UPON,
ACKNOWLEDGE WHAT YOU JUST SAID,
CONTEXTUAL FEATURES OR ISSUES.
AND THAT'S WHY IT WAS ADDED.
BUT I THINK THAT WE CAN
CERTAINLY MAKE A CHANGE TO THE
CHARGE, AND ALSO REFLECT THAT IN
THE RECOMMENDATION DOCUMENT.
>> BUT IT SEEMS LIKE THOSE
CONSIDERATIONS WILL BE RELEVANT
TO A LOT OF QUESTIONS, KEEP IT
BUT PUT IT IN THE BIGGER
INTRODUCTION, NOT THIS SECTION.
>> I DO KNOW WHEN THIS
CONVERSATION, WHEN WE WERE
TALKING ABOUT THIS CONVERSATION
THERE WERE COMMENTS ALSO FROM
SOME EXPERTS THAT SPENT TIME
TALKING ABOUT NOT ONLY THE
COMPLEXITIES OF THE LAWS AND
REGULATIONS AND GUIDELINES AND
THOSE KINDS OF THINGS, HOW YOU
ACTUALLY CONDUCT RESEARCH IN
THIS AREA, BUT THEY FOCUSED A
LOT OF THEIR ATTENTION ON THE
IMPACT OF POLITICAL AND SOCIAL
DETERMINANTS OF HEALTH AS WELL.
AGAIN, I WANTED TO PUT THAT OUT
THERE.
THAT'S WHERE THAT LANGUAGE CAME
FROM, WHY IT WAS ADDED.
OKAY.
ALLISON, I'LL GO TO YOU NEXT.
>> I JUST WANTED TO POINT OUT,
AS MAYBE A REFERENCE OR
WHATEVER, FOR THE DOCUMENTS THAT
THE WHITE HOUSE RELEASED AN
EXECUTIVE ORDER ON ADVANCING
WOMEN'S HEALTH.
I'M A HUGE FAN OF HAVING, YOU
KNOW, SIMILAR LANGUAGE BETWEEN
VARIOUS THINGS, UNLESS THERE IS
A REASON TO HAVE DISSENTING
LANGUAGE OR FRAME THINGS
DIFFERENTLY.
I THOUGHT THAT WOULD BE A GOOD
RESOURCE TO LOOK AT HOW THEY
ADDRESS SOME OF THESE ISSUES IN
THE CONTEXT OF WOMEN AND WHERE
NECESSARY MAKE CHANGES BUT WHERE
THE LANGUAGE WORKS JUST GO AHEAD
AND USE IT.
>> OKAY.
I'M MAKING A NOTE.
EXCUSE ME, I'M TAKING NOTES
HERE.
>> I PUT THE LINK IN THE CHAT.
>> OKAY.
THANK YOU.
>> UH-HUH.
>> RUQAIIJAH?
>> A MINOR POINT, WHEN YOU WERE
DELETING PART, YOU DELETED
GUIDELINES.
YOU CAN KEEP THOSE THERE.
>> THANK YOU.
IN TERMS OF THIS SECTION THEN
ARE THERE ANY OTHER POINTS YOU
WANT TO MAKE BEFORE WE MOVE ON
TO THE NEXT?
I THINK -- I'M GOING TO MOVE
DOWN TO THE NEXT SECTION.
WE CAN ALWAYS COME BACK UP IF WE
NEED TO.
THE NEXT SECTION IS ON
ESTABLISHING INCLUSIVE AND
CULTURALLY SENSITIVITY RESEARCH
ENVIRONMENT.
COMMUNITY ENGAGEMENT,
COMPOSITION OF STUDY TEAM,
CULTURAL COMPETENCE,
INTERSECTIONALITY.
SO, HERE AGAIN THIS IS SORT OF
THE -- THESE ARE THE QUESTIONS
THAT WE'RE LOOKING AT.
I THOUGHT WE COULD MAYBE DELVE
MORE INTO EACH OF THESE.
I'LL START WITH COMMUNITY
ENGAGEMENT.
AND GETTING INTO MORE SPECIFICS
REGARDING WHAT KINDS OF THINGS
YOU WOULD LIKE TO SEE IN THIS
SECTION.
LOIS?
>> I GUESS TWO THINGS.
I FEEL LIKE WE'RE GOING TO NEED
TO DRAW ON EXPERTISE.
SO, TO SOME EXTENT THIS DOCUMENT
ESPECIALLY IS GOING TO NOT, YOU
KNOW, WHY THEY SHOULD, RIGHT?
BUT HOW CAN, RIGHT?
A LOT OF THESE QUESTIONS ARE HOW
CAN RATHER THAN A QUESTION OF
WHAT SHOULD BE DONE THAT, YOU
KNOW, MAYBE IN SOME WAYS -- I'M
ASKING QUESTIONS WHETHER IN SOME
WAYS THIS DOCUMENT IS GOING TO
BE TRYING TO HIGHLIGHT GOOD
RESOURCES.
OR IS THIS PROJECT NOT JUST
DOCUMENT, THE ONE WE EVENTUALLY
COME UP WITH, IS IT GOING TO BE
THE RESOURCE ITSELF?
SO THAT'S ONE QUESTION I HAVE
BECAUSE IT COULD BE A HUGE, HUGE
PROJECT OR IS IT MORE OF A WE'VE
GATHERED THESE KINDS OF THINGS
TOGETHER IN A HELPFUL WAY FOR
ALL THESE STAKEHOLDERS TO ACCESS
THINGS THAT WE THINK ARE GOOD.
SO THAT'S ONE QUESTION.
AND THEN THE OTHER QUESTION IS
JUST GOING FORWARD THINKING
ABOUT ULTIMATE THING WE PRODUCE,
THAT IT MIGHT BE HELPFUL TO HAVE
SOME CASE STUDIES.
ESPECIALLY I WAS THINKING BACK
ON THE ONE WE'VE ALREADY LEFT
ABOUT THE LAWS BUT ALL OF THESE
THINGS INTERACT, INTERRELATE.
BUT WITH SOME EXAMPLES OF HOW
WITH THESE, YOU KNOW, COMPLEX
REGULATIONS AND LAWS THAT MAY BE
AT SOME POINTS, YOU KNOW, AT
LOGGERHEADS, HOW DOES ONE
NAVIGATE THAT?
OR WHAT ARE WE TRYING TO GIVE
TOOLS OR TRYING -- I GUESS
THAT'S THE -- I'M WONDERING WHAT
THIS ULTIMATE DOCUMENT MIGHT BE
LOOKING LIKE, WHAT PEOPLE'S
THOUGHTS ARE ON THAT.
>> ANY OTHERS ON THAT?
LET'S SEE HERE.
SANDRA?
>> NO, NO, I HAVE A SIMILAR
QUESTION.
I GUESS I WAS THINKING IT WAS
NOT ONLY GOING TO BE HOW DO YOU
DO IT BUT ALSO WHY SHOULD YOU DO
IT.
AND SO THIS IS WHERE, YOU KNOW,
IN TERMS OF COMMUNITY
ENGAGEMENT, ETHICAL FRAMING OF
THIS IN TERMS OF RESPECT MIGHT
BE GOOD TO MENTION IN TERMS OF
WHY YOU MIGHT WANT TO DO IT.
THE OTHER IS THAT IT SEEMS SOME
OF THESE SUBPOINTS MIGHT BE
SYNERGISTIC WITH EACH OTHER.
THE IDEA THAT YOU SHOULD DO
COMMUNITY ENGAGEMENT AND HOW YOU
MIGHT DO IT IS RELATED TO THE
COMPOSITION OF THE STUDY TEAM IN
TERMS OF EXPERTISE IN COMMUNITY
ENGAGEMENT.
I COULD SEE THOSE BEING
SYNERGISTIC.
SO, JUST TO THINK ABOUT THESE
LESSONS KIND OF SEPARATE BULLET
POINTS I GUESS BUT IN
COMMUNICATION WITH EACH OTHER.
>> OKAY.
KEVIN?
>> TO LOIS' QUESTION, I HAD THE
REACTION GOING THROUGH THIS THAT
FOR SOME OF THESE I MEAN THE
ANSWERS TO THESE QUESTIONS, YOU
KNOW, ARE FAIRLY MASSIVE
TOOLKITS AND REPORTS BY OTHER
GROUPS.
AND SO I WAS GUESSING WE'RE NOT
PRODUCING THAT, AND SO WE WOULD
NEED TO TRY TO IDENTIFY THOSE
RESOURCES THAT ARE OUT THERE, OR
RESOURCES THAT COULD BE ADAPTED,
FOR EXAMPLE, THERE'S A LOT OF
GREAT STUFF ON INCORPORATING
PERSPECTIVES INTO THE DESIGN OF
STUDIES AND THINGS LIKE THAT,
BEST PRACTICES FOR THAT.
THE SAME QUESTIONS WERE COMING
TO MY MIND AS LOIS ASKED.
s I WOULD SAY IT'S PRACTICALLY
IMPOSSIBLE FOR US TO GIVE A
REALLY THOROUGH ANSWER TO SOME
OF THESE BUT WE COULD UNDERSCORE
WHY THEY ARE IMPORTANT AS SANDRA
SAID, AND POINT TO SOME
RESOURCES THAT COULD BE
AVAILABLE TO FOLKS.
>> OKAY.
MY UNDERSTANDING IT'S A
COMBINATION OF THE WHY HIGHER
LEVEL BUT ALSO HOW, BUT NOT IN
LOOKING AT SOME OTHER SACHRP
RECOMMENDATIONS THEY TEND TO
BE -- THERE'S A LITTLE BIT OF
SPECIFICITY BUT TYPICALLY NOT
GOING TO BE LIKE A TOOLKIT SO I
AGREE WITH YOU ON THAT.
WE WANT IT TO BE HELPFUL, I
WOULD IMAGINE.
SO THAT IT'S NOT JUST THE WHY.
BUT OF COURSE EACH OF THESE
TOPICS, COMMUNITY ENGAGEMENT
JUST BY ITSELF, JUST THE FIRST
QUESTION, TOOL KIT WOULD BE
QUITE A MASSIVE UNDERTAKING.
BUT THERE'S STILL A LOT OF
LESSONS LEARNED FROM OTHER
ORGANIZATIONS THAT DO THIS, AND
MAYBE DOING THIS WELL THAT WE
MIGHT WANT TO INCORPORATE.
SO, AGAIN, THAT'S GOING TO BE
PART OF THE EXERCISE PUTTING
TOGETHER THESE RECOMMENDATIONS.
ALL RIGHT.
LET'S TALK ABOUT -- I'M GOING
THROUGH EACH OF THE BULLETS.
ANYBODY HAVE ANYTHING MORE
SPECIFIC ON COMPOSITION OF THE
TEAM?
SOME EXAMPLES TO SHARE?
HOW YOU SEE YOUR ORGANIZATION,
OTHER ORGANIZATIONS DO THIS,
MAYBE WE CAN INCORPORATE SOME OF
THAT, WE COULD DO THAT AS WELL.
THAT MIGHT BE HELPFUL FOR THIS
CONVERSATION AS WELL, NOT JUST
SORT OF LIKE A HIGH LEVEL.
I KNOW ONE OF THE COMMENTS THAT
CAME UP HERE WAS THE FACT THAT
IN TERMS OF ENSURING YOUR
COMPOSITION, YOU KNOW, REFLECTS
THE COMMUNITY'S PERSPECTIVE ONE
OF THE COMMENTS WAS THAT EVEN IF
YOU HAVE CERTAIN MEMBERS OF THE
COMMUNITY, THESE COMMUNITIES ON
SAY YOUR IRB FOR EXAMPLE THAT
EVEN THAT INDIVIDUAL MAY NOT BE
ABLE TO FIX THE ENTIRE
COMMUNITY.
THINGS LIKE THAT THAT WE NEED TO
FLESH OUT.
SO IT WOULD BE HELPFUL TO HEAR
DO YOU HAVE ANY EXPERIENCE WITH
THIS, EXAMPLES YOU WANT TO
SHARE, THAT WE CAN MAYBE ADD TO
RECOMMENDATIONS ON THIS.
>> NOT FOR THIS POPULATION BUT,
YOU KNOW, WE'VE HAD THE SAME
PROBLEMS IN PEDIATRICS, YOU
KNOW.
LIKE WE HAVE TO HAVE A PEDIATRIC
SPECIALIST REVIEWING PROTOCOLS
DEALING WITH KIDS.
I MEAN, YOU KNOW, WHAT KIND OF
PEDIATRIC SPECIALIST?
YOU COULD HAVE SOMEONE WHO KNOWS
ABSOLUTELY NOTHING ABOUT THE
PROCEDURES INVOLVED, THE RISKS,
YOU KNOW, WHATEVER, WHATEVER.
SO, YEAH, I THINK JUST BECAUSE
SOMEONE HAS A PARTICULAR NAME OR
PARTICULAR IDENTITY DOES NOT
NECESSARILY MEAN THAT THEY ARE
COMPETENT TO BRING THE LIVED
EXPERIENCE OR THE, YOU KNOW,
KNOWLEDGE THAT WE WOULD BE
WANTING.
>> ANOTHER EXAMPLE WOULD BE
TYPICALLY A LOT OF IRBs, WHAT
THEY WILL DO IS IF THEY DON'T
HAVE EXPERTISE ON THE IRB THEY
MIGHT CONSULT WITH SOMEONE THAT
MIGHT HAVE SPECIFIC EXPERTISE IN
A PARTICULAR AREA.
THOSE ARE THE KIND OF THINGS YOU
COULD CONSIDER ADDING TO
RECOMMENDATION DOCUMENT LIKE IN
TERMS OF BEST PRACTICE.
SIMILARLY FOR YOUR STUDY TEAM OR
YOUR ORGANIZATIONAL LEADERSHIP,
MAYBE THERE'S SOME EXAMPLES OUT
THERE IN TERMS OF BEST PRACTICES
ON HOW YOU MIGHT GO ABOUT DOING
THAT.
SO THAT'S JUST AN EXAMPLE.
OKAY.
LET'S MOVE ON TO CULTURAL
COMPETENCE.
IN THIS ONE, THIS SPEAKS TO THE
ISSUE OF FOSTERING CULTURING
AWARENESS, HUMILITY, I GAVE
EXAMPLES ABOUT WHETHER IT'S
EDUCATION IN TRAINING, CREATING
AN ENVIRONMENT THAT IS OPEN,
THOSE KINDS OF THINGS.
BUT I THINK THIS ONE YOU MIGHT
WANT TO TALK ABOUT A BIT.
RUQAIIJAH, YOU MADE SOME
COMMENTS EARLIER.
DID YOU WANT TO MAYBE SURE, I
DON'T WANT TO PUT YOU ON THE
SPOT, YOUR THOUGHTS ON THIS
BECAUSE THIS MIGHT BE ONE WHERE
I MIGHT BE SIMPLIFYING THE
EDUCATION AND TRAINING WE ALWAYS
SAY BUT THERE'S MORE TO IT.
THAT MIGHT BE HELPFUL FOR YOU TO
SHARE YOUR THOUGHTS.
>> YES, THANK YOU FOR THAT,
LINDA.
I WOULD SAY THE DISCUSSION THAT
WE HAD DURING THE SUBCOMMITTEE
WAS THAT WE DIDN'T WANT TO JUST
STOP THAT CULTURAL COMPETENCY
BUT THAT PRESUMES YOU COULD TAKE
A CLASS AND LEARN EVERYTHING YOU
NEED TO KNOW, WHEREAS HUMILITY
SIGNALS CONTINUATION OF
LEARNING, AND ALSO ALLOWS YOU TO
FULLY UNDERSTAND THAT IT'S
NOT -- ONE PERSON IS NOT GOING
TO BE REPRESENTATIVE OF ALL
VIEWPOINTS, DIVERSE VIEWPOINTS.
I LIKE THE LANGUAGE HERE IN
TERMS OF CULTURAL AWARENESS,
EVEN UNDERSTANDING THAT PEOPLE
MAY VIEW THINGS OR TAKE THINGS
DIFFERENTLY, COMPETENCY IS STILL
THERE BECAUSE IT IS A WORD THAT
PEOPLE TEND TO USE MORE OFTEN
THEN HUMILITY, UNDERSTANDING
IT'S IMPORTANT TO ASK QUESTIONS
OF INDIVIDUALS, OF PEOPLE FROM
DIFFERENT AND DIVERSE
COMMUNITIES.
AND CONTINUE THAT LEARNING.
>> THANK YOU.
DOES ANYBODY HAVE COMMENTS ON
THIS SECTION, THIS QUESTION AT
ALL?
ANYTHING YOU WANT TO ADD?
ANY CLARIFICATIONS?
KEVIN?
>> I WANT TO SAY I LOVE WHAT
RUQAIIJAH SAID.
WE COULD MAKE THAT A LOUD
STATEMENT.
BECAUSE THERE ARE SO MANY TIMES
WHEN WE'RE JUST OFFERING
WORKSHOPS OR WATCH SOMETHING AND
CHECK A BOX, BUT UNDERSCORING
THAT IT REQUIRES HUMILITY AND
CONSTANT LISTENING AND
QUESTIONING.
THINGS ARE ALWAYS CHANGING TOO.
THAT SEEMS LIKE A REALLY
IMPORTANT MESSAGE.
>> OKAY.
LOIS?
>> YES.
GOING BACK TO THE KIND OF THE
WHY AND HOW QUESTION, I'M
THINKING FOR EXAMPLE OF THE
QUESTION HOW CAN INVESTIGATORS,
SPONSORS, IRBs, RESEARCH
INSTITUTIONS ACTIVELY PROMOTE,
RIGHT?
AND, AGAIN, I MEAN I'M NOT
AGAINST US COMING UP WITH A LIST
OF RESOURCES AND DOING SOMETHING
LIKE THAT BUT MAYBE PART OF WHAT
WE SHOULD BE THINKING ABOUT IS
MORE WHY SHOULD THEY, HOW MUCH
SHOULD THEY, HOW MUCH ATTENTION
SHOULD BE PLACED ON THIS.
WHEN DO YOU KNOW IF YOU HAVE
ENOUGH?
WHEN DO YOU KNOW IF YOU'VE DONE
A GOOD ENOUGH JOB?
NOT SO MUCH THE PRACTICAL,
ALTHOUGH THAT'S IMPORTANT IF WE
CAN FIND GREAT RESOURCES, BUT
WHY IT'S IMPORTANT AND HOW
IMPORTANT IT IS COMPARED TO
OTHER THINGS.
THAT ETHICAL WAY, HOW MANY
COMMUNITY PERSPECTIVES DOES ONE
NEED?
THOSE TO ME ARE MORE THE ETHICAL
QUESTIONS RATHER THAN PRACTICAL
HOW TO GO ABOUT DOING THIS.
THAT'S -- YOU KNOW, JUST AS WE
MOVE FORWARD SEEMS TO ME WE WANT
TO TRY TO FIGURE OUT WHAT THOSE
KIND OF TOUGH QUESTIONS ARE, IF
SOMEONE IS READING THIS, WE
DON'T DO ANY OF THIS, WE DO
SOME, BUT NOT AS FAR AS OUR
MECHANISMS, BUT HAVE WE MET THE
BAR?
IS THERE A BAR HERE TO MEET?
TO ME THOSE ARE THE QUESTIONS
THAT ARE MORE ETHICAL QUESTIONS.
>> LINDA, THIS IS JULIA.
I DON'T MEAN TO JUMP THE LINE
PER SE.
BUT I DID WANT TO JUST TAKE A
MOMENT TO COMMENT THAT AT THIS
POINT IT WAS OHRP'S GENERAL
EXPECTATION THAT THE CHARGE PER
SE WAS ESSENTIALLY COMPLETE.
AND FINAL.
AND THAT ASIDE FROM, YOU KNOW,
EXPLAINING THE CONCEPTS AND
DISCUSSION THAT WE'VE HAD OVER
THE PAST FEW MONTHS WE WERE
HOPING THAT MOST OF THE FOCUS IN
TODAY'S MEETING WAS GOING TO
MOVE BEYOND JUST THE CHARGE
INTO, YOU KNOW, THE ACTUAL TEXT,
STARTING OF THE RECOMMENDATIONS
THEMSELVES.
I WANT TO PUT THAT OUT THERE AS
PREDICATE.
ALSO, I THINK LINES 27 AND 28,
GIVEN SOME EDITING AND SOME OF
WHAT WE'VE HEARD, MAYBE THIS
LINE NEEDS A LITTLE BIT OF AN
EDIT RATHER THAN SAYING SIMPLY
OHRP SEEKS INPUT FROM SACHRP
REGARDING, YOU KNOW, THE
FOLLOWING QUESTIONS, THAT, YOU
KNOW, SOMETHING TO THE EFFECT
OF, YOU KNOW, SACHRP IS -- HOPES
TO ADDRESS THE FOLLOWING
QUESTIONS.
>> OKAY.
>> I'LL MAKE A NOTE.
>> JULIA, POINT OF
CLARIFICATION.
I KNOW RUQAIIJAH'S HAND WAS UP.
SOME CONFUSION ON MY PART, I
DON'T WANT TO SPEAK ON BEHALF OF
THE OTHER MEMBERS, WHAT WAS SENT
TO US WAS THIS WORD DOCUMENT
WHICH MAKES IT FEEL LIKE WE WERE
SUPPOSED TO EDIT IT.
>> YEAH, NO, I UNDERSTAND THAT.
YOU KNOW, I TOTALLY TAKE THE
BLAME HERE IF THERE'S ANY
CONFUSION REGARDING THIS.
I THINK THAT THE INTENT HAD BEEN
TO GO OVER THIS DOCUMENT,
EXPLAIN THIS DOCUMENT, WHERE THE
DOCUMENT WAS HOPING TO GO.
YOU KNOW, PRINCIPLES, ET CETERA.
BUT AT SOME POINT HERE WE'RE
HOPING TO MOVE BEYOND EDITING
THE CHARGE.
I'M SORRY, LINDA.
I HOPE THAT WAS YOUR
UNDERSTANDING.
>> IT WAS MY UNDERSTANDING.
I DID SAY IT BUT I DIDN'T WANT
TO OBVIOUSLY SINCE THERE WAS
COMMENTARY.
>> RIGHT.
I JUST DON'T WANT THIS ENTIRE
SESSION HERE TO FOCUS ON THE
CHARGE.
WE REALLY ARE CONSIDERING THE
CHARGE MORE OR LESS COMPLETE.
AND ARE HOPING TO GO BEYOND THAT
AT THIS POINT.
>> GREAT.
I'LL TURN IT BACK TO RUQAIIJAH
OR LINDA.
I DIDN'T SEE A SECOND DOCUMENT,
THE LARGE DOCUMENT.
WE WEREN'T SUPPOSED TO REVIEW
THAT.
>> THAT'S TRUE.
>> THANK YOU.
>> SORRY FOR THE INTERRUPTION.
>> NO, THANK YOU, JULIA.
I'M GLAD YOU REITERATED THAT
POINT.
THE DOCUMENT IS JUST A CHARGE.
THE IDEA WAS TO ACTUALLY TALK
ABOUT THE CONTENT OF THE
FIRST -- SO WE CAN START
DRAFTING THE RECOMMENDATIONS.
LET ME -- NOT SURE WHO WAS NEXT.
I THINK IT WAS RUQAIIJAH.
>> YEAH, COULD I ASK A QUESTION
ABOUT THAT, JULIA?
SO, I CAN BE GETTING THIS
CONFUSED.
FROM MY REFERENCE POINT WE'VE
GONE OVER THIS DOCUMENT A FEW
TIMES IN THE SUBCOMMITTEE BUT I
FEEL LIKE THIS IS THE FIRST TIME
THAT SACHRP AS A GROUP HAS
REVIEWED THE DOCUMENT TO TALK
ABOUT WHAT WE'VE DONE IN THE
SUBCOMMITTEE.
IS THAT INCORRECT?
OR -- AND THEN HOW DO WE PROCEED
WHEN THINGS ARE LIKE FINALIZED
IN THE SUBCOMMITTEE AND THEN WE
SEE IT AND WE STILL SEE POINTS?
>> THE CHARGE I BELIEVE HAD BEEN
PRESENTED BACK IN OCTOBER AT THE
OCTOBER MEETING.
AND THE INTENT HAD BEEN TO BE
DISCUSSING IT, YOU KNOW,
CONSIDERING THE CONTENT FOR THE
RECOMMENDATIONS THEMSELVES AT
THE SUBCOMMITTEE LEVEL.
AND IN THE PAST, CHARGES FOR
PARTICULAR TOPICS HAVE BEEN
HANDLED A VARIETY OF WAYS.
SOMETIMES THEY COME PURELY FROM
OHRP.
SOMETIMES IT'S A CROSS-EFFORT
REALLY WITH OHRP, AND SACHRP, OR
THE SUBCOMMITTEES, AND WILL
BECOME PART OF THE
RECOMMENDATIONS THEMSELVES.
I WOULD EXPECT THAT WITH THIS
DOCUMENT IT WOULD PROBABLY BE
THE LATTER WHERE IT WOULD BE
HELPFUL TO SEE THE CHARGE AS
PART OF THE DOCUMENT THAT HAS
THE RESPONSIVE RECOMMENDATIONS.
AT THE END SACHRP IS VOTING ON
THE DOCUMENT AS A WHOLE.
>> THANKS.
THAT'S HELPFUL.
I WOULD SAY, YES, FOR ME, AND I
DON'T KNOW ABOUT OTHER PEOPLE, I
KNOW WE TALKED ABOUT IT IN
OCTOBER.
BUT WE DIDN'T HAVE THIS DOCUMENT
UNTIL NOW.
AND SO I THINK IT'S HELPFUL FOR
US AT LEAST WHAT I'M HEARING
PARTICULARLY FROM LOIS AND KEVIN
AND OTHERS IS THAT LOOKING AT
THIS DOCUMENT AND THEN
TRANSLATING IT INTO
RECOMMENDATIONS THAT THESE
CHANGES ARE TO TRY TO HELP US
GET TO THE RECOMMENDATIONS, AND
ONE OF MY SUGGESTIONS WHY I
RAISED MY HAND IS THAT IT WAS
GOING BACK TO THE INITIAL
DISCUSSION ABOUT HOW THERE SEEMS
TO BE SOME OVERLAP, PARTICULARLY
UNDER 2, GETTING TO HOW DO WE
RECOMMEND THE THINGS THAT PEOPLE
ARE DOING.
I FEEL LIKE ALMOST IF WE COULD
TIE COMMUNITY ENGAGEMENT TO YOUR
SECOND BULLET, AND TO THE THIRD
BULLET UNDER HERE WHEN WE TALK
ABOUT COMPOSITION AND CULTURAL
COMPETENCE, IT ALMOST IS REALLY
TALKING ABOUT THE FACT THAT
COMMUNITY ENGAGEMENT IS ONE OF
THE WAYS THAT WE CAN FIGURE OUT
IF THE COMPOSITION OF THE STUDY
TEAM IS APPROPRIATE, IF THERE IS
ACTUAL CULTURAL COMPETENCE.
AND I THINK THAT WILL TIE IT TO
SOME OF OUR RECOMMENDATIONS THAT
WE DO.
AND CAN TALK ABOUT LATER IS THAT
REALLY THE COMMUNITY ENGAGEMENT
IS THROUGHOUT THE WHOLE PROCESS,
AND SO IT SHOULDN'T JUST BE LIKE
ONE INDIVIDUAL ON THE STUDY TEAM
BUT GOING BACK TO WHAT YOU
TALKED ABOUT, LINDA, LIKE
CONSULTATION, RIGHT?
NOT JUST WITH THE INDIVIDUAL BUT
MAYBE ALSO WITH COMMUNITY.
AND THE SAME THING AROUND
CULTURAL COMPETENCY.
IT'S NOT LIKE YOU'RE GOING TO
GET A CERTIFICATE IN THESE
THINGS BUT IF YOU CONTINUE TO
ENGAGE WITH THE COMMUNITY THEN I
THINK YOU COULD ACTUALLY GET TO
THE POINT THAT YOU WANT TO, SO I
WOULD EVEN SUGGEST THE EVEN JUST
PUTTING A COMMA AFTER, TO
REFLECT COMMUNITY PER
PERSPECTIVES OBTAINED THROUGH
COMMUNITY ENGAGEMENT, SAME FOR
CULTURAL COMPETENCY.
AND WHEN WE GET TO
RECOMMENDATIONS REALLY THINK
ABOUT WHAT WE'RE RECOMMENDING
FOR PEOPLE.
I THINK IT'S GOING TO BE AN
EASIER THING TO TRANSITION.
>> NO, THANK YOU, RUQAIIJAH.
THAT DOES MAKE SENSE.
WHEN I LOOKED AT SOME OF THESE
HEADINGS, I THINK FROM COMMUNITY
ENGAGEMENT DOES OBVIOUSLY PLAY A
ROLE IN EVERYTHING WE DO HERE,
BUT I THINK THERE'S SPECIFIC
RECOMMENDATIONS YOU MIGHT WANT
TO CONSIDER AS A COMMITTEE, THAT
ARE JUST FOCUSED ON COMMUNITY
ENGAGEMENT, THAT WOULD BE
SEPARATE FROM SOME OF THESE
AREAS AS WELL.
I THINK IT'S BOTH.
IT'S BOTH INTEGRATED, WOVEN
THROUGHOUT WHAT WE'RE TALKING
ABOUT TODAY, ALSO THERE'S
SEPARATE CONSIDERATIONS, LOTS OF
MOVED ALSO THAT VIEW, LOOK FROM
THAT PERSPECTIVE.
FOR PURPOSES OF THE
RECOMMENDATION DOCUMENT WE CAN
CERTAINLY DO THAT.
I THINK, AGAIN, THE PURPOSE OF
CALLING OUT SPECIFIC QUESTIONS
WAS JUST TO MAKE SURE WE'RE NOT
MISSING ANYTHING, AS WE'RE
WRITING THE DOCUMENT YOU CAN DO
ALL THE THINGS YOU'RE TALKING
ABOUT, RUQAIIJAH.
I THINK THAT'S WHAT WE WERE
THINKING AT THE TIME ANYWAY.
SOME OTHER PEOPLE HAVE HANDS UP,
BUT I CAN'T -- DON'T SEE THEM
ANYMORE.
DOES ANYBODY HAVE THOUGHTS ON
ANY OF THE OTHER TOPICS,
INTERSECTIONALITY, NOT IN TERMS
OF THE QUESTION ITSELF BUT JUST
IN TERMS OF CERTAIN INFORMATION
OR EXAMPLES OF THINGS WE MIGHT
WANT TO ADD TO RECOMMENDATION
DOCUMENT ON INTERSECTIONALITY?
ANY THOUGHTS THERE?
NO?
OKAY.
LET'S MOVE ON TO THE NEXT
SECTION.
SO THIS GETS TO -- THIS IS ABOUT
THE DESIGN, REVIEW, CONDUCT,
DISSEMINATION OF RESULTS.
SANDRA?
>> ANOTHER RESOURCE THAT WE
COULD POINT TO, I'M SURE YOU'RE
AWARE NASEM, NATIONAL ACADEMIES
REPORT ON HOW YOU MEASURE SEX,
GENDER, ORIENTATION, THEY GO
THROUGH A LOT OF THINGS THAT ONE
MIGHT CONSIDER IN TERMS OF
RESEARCH DESIGN AND ANALYSIS
MAKING SURE THAT DIFFERENT
VARIABLES ARE NOT KIND OF BEING
USED IN PRECISELY FOR PROXIES
FOR BIOLOGICAL DIFFERENCES AND
THINGS LIKE THIS.
THIS IS A GOOD RESOURCE I THINK
TO PERHAPS REFER TO.
>> THANK YOU.
KEVIN?
>> YEAH, INTERSECTIONALITY IS
MAKING ME THINK ABOUT THE GREAT
DISCUSSION THAT I READ.
I WASN'T AT THE LAST MEETING BUT
I READ, AND THE PRESENTATION
THAT FOCUSED ON ESPECIALLY
TEENS, IT SEEMS LIKE THERE WERE
A LOT OF THESE ISSUES THAT MIGHT
BE SOME SPECIFIC CONSIDERATIONS
FOR YOUNGER FOLKS, AND IS THAT
SOMETHING WE ADDRESS UNDER
INTERSECTIONALITY HERE, IS THAT
A SPECIAL -- ADDRESSING -- I WAS
REMEMBERING ALL THE REALLY GOOD
MATERIAL THAT WAS THERE AND
WANTED TO KNOW, YOU KNOW, WHAT'S
THE BEST WAY TO REFLECT THAT AND
OUR ANSWERS TO THIS DOCUMENT.
>> SO THE ANSWER IS YES, WE
WOULD BE FOCUSING ON BOTH MINORS
AND ADULTS.
FOR EACH -- FOR ALL THESE
QUESTIONS, TO THE EXTENT THEY
ARE APPLICABLE.
I'M GOING TO MOVE ON TO THE
CONSIDERATIONS FOR DESIGN,
REVIEW, AND CONDUCT OF RESEARCH.
THERE ARE, LET'S SEE, SIX
QUESTIONS.
WE CAN START WITH RESEARCH,
DESIGN, AND ANALYSIS.
>> I DON'T KNOW IF THIS IS
REALLY THE PLACE TO PUT THIS IN
BUT I WANT TO MAKE SURE THAT WE
ADDRESS, AND THIS GETS INTO YOUR
CATEGORIES OF RESEARCH AT THE
VERY BEGINNING, BUT THAT THE
DESIGN AND ANALYSIS INTERSECT
APPROPRIATELY WITH INCLUSION
APPROACHES THAT REFLECT THE
PURPOSE OF INCLUSION AND
REPRESENTATION OF THESE
COMMUNITIES.
WHAT I MEAN BY THAT IS THERE
WILL BE TIMES WHERE IT'S REALLY
IMPORTANT TO HAVE ADEQUATE
REPRESENTATION TO MAKE
SCIENTIFIC INFERENCES.
THERE ARE OTHER TIMES WHERE
YOU'RE DOING IT AS A RESULT OF A
MORAL IMPERATIVE TO BE BROADLY
INCLUSIVE OF RESEARCH.
THOSE HAVE IMPORTANT SCIENTIFIC
CONNECTIONS.
>> OKAY.
THANK YOU.
>> I THINK THOSE DISTINCTIONS
OFTEN GET LOST, IF WE CAN
HIGHLIGHT THEM IT WOULD BE
HELPFUL.
>> OKAY.
LET'S SEE.
SANDRA?
>> NEIL, I DON'T KNOW IF THIS IS
WHAT YOU'RE GETTING AT, BUT
MAYBE SIMILARLY, TRYING TO
ATTEND TO THE GOAL OF
INCLUSIVENESS.
BUT BEING MINDFUL THAT DATA IS
BEING COLLECTED TO ANSWER THE
QUESTIONS, THE RESEARCH QUESTION
AND APPROPRIATE WAY, HAVING DATA
PARSIMONY, IF YOU WILL, LIKE THE
IDEA THAT YOU COLLECT DATA FOR
ANSWERING THE QUESTION.
AND THEN CONSIDERATIONS ABOUT
REPRESENTATION SHOULD ALSO BE
CONSIDERED BUT YOU DON'T WANT TO
NECESSARILY INCLUDE INFORMATION
ABOUT SEXUAL IDENTITY THAT ISN'T
TIED NECESSARILY TO THE RESEARCH
QUESTION, OR TRYING TO BALANCE
KIND OF THE RISKS AROUND
COLLECTING INFORMATION AND IT
NOT BEING NECESSARILY TIED TO
RESEARCH QUESTIONS.
BUT NEIL YOU'VE UNMUTED SO MAYBE
YOU HAVE YOU HAVE SOMETHING TO
SAY.
>> I WOULD SECOND WHAT YOU JUST
SAID.
I AGREE 100%.
I THINK THERE IS A SEPARATE
ISSUE WHEN I'M THINKING LESS
ABOUT TYPES OF DATA COLLECTION
AND WHAT NOT, AND MORE INCLUSION
IN STUDIES WHERE LINES CAN GET
BLURRED BETWEEN WHEN YOU ARE
INCLUDING PEOPLE BECAUSE YOU'RE
INTENDING TO DRAW SPECIFIC
INFERENCES ABOUT THAT POPULATION
VERSUS WHEN YOU'RE INCLUDING
PEOPLE BECAUSE YOU WANT RESEARCH
IN GENERAL TO BE AN INCLUSIVE
ACTIVITY THAT, YOU KNOW, FOR
DIFFERENT -- FOR REASONS, MAYBE
THERE'S SCIENTIFIC
CONSIDERATIONS SOMETIMES TOO BUT
FOR REASONS OTHER THAN JUST
SCIENCE.
SO I'M THINKING TO PUT A SHARP
POINT OUT SOMETIMES YOU NEED TO
DO SUBGROUP ANALYSIS, OTHER
TIMES YOU HAVE NO INTEREST, BUT
YOU WOULDN'T WANT TO EXCLUDE
THEM BECAUSE THIS IS SUPPOSED TO
BE FOR JUSTICE-RELATED REASONS,
PROMOTION OF TRUST, ALL SORTS OF
REASONS, IT'S REALLY IMPORTANT
TO BE INCLUSIVE AND
REPRESENTATIVE.
SO I THINK TEASING THOSE ISSUES
APART IS REALLY IMPORTANT AND
OFTEN GET BLURRED, A LOT OF
EFFORT TO INCREASE DIVERSITY IN
RESEARCH RIGHT NOW IT'S REALLY
IMPORTANT TO BE ATTENTIVE TO
YOUR GOALS IN THE CONTEXT OF
SPECIFIC STUDIES.
>> YEAH, I WOULD AGREE
WHOLEHEARTEDLY, THINKING ABOUT
PERHAPS THE ANALOGOUS SITUATION
WITH SOME OF THE DISCUSSION
WE'VE HAD AROUND POPULATION
DESCRIPTORS OF RACE AND
ETHNICITY AND HOW THAT
CONFLATION CAN EASILY HAPPEN
WHEN PEOPLE ARE NOT BEING
PRECISE ABOUT WHY THEY WERE
USING CERTAIN IDENTIFIERS.
>> KEVIN?
ADD TO THAT, I COMPLETELY AGREE.
IT'S REALLY IMPORTANT AND AN
EXAMPLE OF A SITUATION WHERE THE
RESEARCH QUESTIONS MIGHT NOT
REQUIRE THAT WE NEED TO COLLECT
SUFFICIENT SAMPLES TO DO
SUBGROUP ANALYSES BECAUSE WE'VE
GOT SCIENTIFIC QUESTIONS ABOUT
RELATIONSHIPS AMONG VARIABLES IN
THOSE GROUPS, BUT WE'RE
DEVELOPING A SURVEY MEASURE, FOR
EXAMPLE, AND WANT TO MAKE SURE
THAT EVERYONE -- FIRST, THAT
WE'RE RECRUITING REPRESENTATIVE
SAMPLES, AND THAT EVERYONE WHO
SEES THOSE SURVEY QUESTIONS
FEELS LIKE THOSE QUESTIONS MAKE
SENSE TO THEM.
AND FOR THEM.
AND IT'S NOT PUTTING THEM OFF
WITH SOME LANGUAGE.
WE RUN INTO THAT ALL THE TIME
WHERE THE STUDY MAY NOT HAVE A
SPECIFIC FOCUS ON LGBTQ+
POPULATIONS BUT THERE ARE LGBTQ+
PARTICIPANTS IN THE STUDY AND WE
DIDN'T REALLY THINK AHEAD BUT
ACTUALLY THIS QUESTION READS A
LITTLE BIT HETERONORMATIVE WEIRD
FOR SOME PEOPLE.
IT'S A REALLY IMPORTANT POINT TO
MAKE THAT DISTINCTION THAT
NEIL'S CALLING OUT WHEN WE'RE
ANSWERING THIS QUESTION.
>> OKAY, THANK YOU.
ANYONE ELSE ON THIS RESEARCH,
DESIGN, AND ANALYSIS PIECE?
OKAY.
WE CAN TURN TO ACCESS AND
INCLUSION.
THIS IS FOCUSED ON RECRUITMENT
PRIMARILY BUT OF COURSE WE
ALREADY TALKED ABOUT INCLUSION
OR DIVERSITY IN THE CONTEXT OF
OTHER QUESTIONS IN THIS
DOCUMENT.
SO ANYTHING HERE WE MIGHT WANT
TO TALK ABOUT?
OR ADD TO RECOMMENDATIONS?
NEIL?
>> YES, I GUESS I WOULD JUST PUT
A PLUG IN FOR I THOUGHT IN OUR
MEETING IN THE FALL THERE NICE
EXAMPLES ABOUT RECRUITMENT
STRATEGIES DEVELOPED BY PEOPLE
EMBEDDED IN, KNEW THE COMMUNITY
WELL, AND OVERSIGHT BODIES,
IRBs AND OTHERS WERE APPLYING
LANGUAGE THAT WAS OUT OF STEP
WITH WHAT THAT COMMUNITY MIGHT
WANT, EXAMPLES OF THE
INVESTIGATORS THAT DESCRIBED
USING THE WORD QUEER ON FLYERS,
THE IRB WANTED HIM NOT TO DO
THAT.
HE'S LIKE THIS IS LANGUAGE THAT
IS WHAT PEOPLE KNOW AND USE TO
REFER TO THEMSELVES.
TO NOT USE THAT LANGUAGE WOULD
NOT BE APPROPRIATELY ENGAGING
WITH THE COMMUNITY.
I THINK IF WE CAN HIGHLIGHT THE
IMPORTANCE OF HAVING RECRUITMENT
STRATEGIES THAT ARE CONSISTENT
WITH NORMS AND EXPECTATIONS FOR
THE COMMUNITIES YOU'RE HOPING TO
ENGAGE AND THAT ARE INFORMED BY
WHAT THEY CARE ABOUT WILL BE AN
IMPORTANT MESSAGE THAT CAN COME
OUT OF THIS.
>> OKAY.
THANK YOU.
AGAIN, THAT TIES INTO THE
FIRST -- THE SECOND SECTION,
CULTURAL COMPETENCE, ALL THOSE
THINGS WE TALKED ABOUT, SORT OF
LIKE -- WE THINK ABOUT THE THREE
CATEGORIES, THE OVERARCHING HIGH
LEVEL AND IT GETS MORE NARROW,
NOW YOU'RE APPLYING THAT TO
THESE AREAS IN TERMS OF CONDUCT
OF RESEARCH.
THIS IS GOING TO BE DIFFICULT,
CHALLENGING TO PULL THIS
TOGETHER BUT A LOT OF THIS IS
NOT GOING TO BE -- IT'S REALLY
GOING TO FLOW INTO OTHER
QUESTIONS AND SOME WILL BE
DISTINCT AND SOME WILL BE --
WILL HAVE TO TIE TOGETHER AND
SOME OF YOU HAVE ALREADY SAID.
ANYTHING ON INFORMED CONSENT
SPECIFICALLY?
SOME OF THE SAME COMMENTS THAT
YOU MADE, NEIL, IN REGARD TO
RECRUITMENT STRATEGY APPLY HERE
AS WELL.
IS THERE ANYTHING ELSE YOU CAN
THINK OF RIGHT NOW?
THAT MIGHT BE SPECIFIC TO
INFORMED CONSENT?
THAT MAY NOT APPLY IN THE
RECRUITMENT PIECE?
>> GO AHEAD, ALLISON OR NEIL.
ALLISON, THEN NEIL.
>> I DON'T HAVE AN ARTICULATED
THOUGHT HERE.
EONS AGO I WROTE WITH A STUDENT
A LITTLE ESSAY ABOUT -- I CAN'T
REMEMBER THE NAME OF THE APP,
GRINDER OR SOMETHING, THE FACT
THAT PEOPLE HAD NO IDEA WHEN
THEY SIGNED UP TO USE THIS APP
THAT SOMEWHERE IN THE FINE PRINT
THEY WERE AGREEING TO LET THEIR
PROFILES BE USED FOR RESEARCH.
SOMETHING ABOUT THE FACT THAT
JUST REMINDING PEOPLE THAT THEY
MAY HAVE CONSENTED TO RESEARCH
WITHOUT EVEN REALIZING THEY WERE
ENGAGING IN CONSENT.
>> OKAY.
>> NOT ALL RESEARCH IS THE SAME.
>> RIGHT.
OKAY.
NEIL?
>> YEAH, AGAIN, WHAT I HAVE TO
SAY IS ENTIRELY UNEARTH
SHATTERING BUT IF WE'RE TRYING
TO AIR THOUGHTS WHAT WE THINK
STRUCTURE OUGHT TO LOOK LIKE AS
THINGS TAKE SHAPE THE TWO KEY
STRUCTURAL COMPONENTS OF
SOMETHING FOCUSED ON CONSENT
WOULD BE, ONE, I GUESS NOT TO
PLAY INTO MAYBE
OVERVULNERABLIZING POPULATIONS
AND RESPECTING THEM AS DECISION
MAKERS, AND SOMETIMES WE CAN BE
OVERPROTECTIVE OF COMMUNITIES
THAT WE THINK HAVE
VULNERABILITIES.
SECOND WOULD BE KIND OF IN THE
CONVERSE OF THAT, BEING WE
SHOULD BE, YOU KNOW, AWARE OF
UNIQUE RISKS OR POTENTIAL
BENEFITS THAT WOULD BE
APPLICABLE TO A PARTICULAR
POPULATION, AND JUST, YOU KNOW,
MAKE AN EFFORT TO BE SUBJECT
CENTRIC IN THE WAY WE THINK
ABOUT WHAT RISKS AND WHAT
BENEFITS ARE LIKELY TO BE
MEANINGFUL AND MIGHT NEED TO BE,
YOU KNOW, HAVE INCREASED
ATTENTION IN THE CONTEXT OF
CONSENT DISCUSSION.
SO BOTH OF THOSE BALANCED
APPROACHES WILL BE REALLY
IMPORTANT AND THINKING ABOUT
COMMUNITIES THAT -- YOU KNOW,
LIKE THIS.
>> OKAY.
I'M GOING TO MOVE ON TO THE
PRIVACY AND CONFIDENTIALITY.
AS WE THINK ABOUT RESEARCH, HOW
IT'S CONDUCTED, WHERE THE DATA
GOES, CONFIDENTIALITY, THOSE
TYPE OF THINGS PROBABLY WOULD BE
IN THIS TYPE OF SECTION IN TERMS
OF MEASURES THAT MIGHT BE TAKEN
BUT THERE MIGHT BE SOME OTHERS
WE MIGHT WANT TO INCLUDE HERE.
I'LL JUST WAIT FOR A MINUTE SO
WE CAN TAKE TIME TO LOOK AT IT.
I KNOW IT'S -- WE COULD INCLUDE
THINGS RELATED TO LIKE
CERTIFICATES OF CONFIDENTIALITY,
AGAIN A QUESTION WOULD BE
WHETHER OR NOT THAT IS THE ONLY
MEASURE YOU WOULD TAKE, RIGHT?
THERE'S PROBABLY OTHER THINGS,
PROBABLY GAPS.
IN TERMS OF EXPERIENCE,
CONDUCTING RESEARCH, IS THERE
ANYTHING ELSE HERE THAT YOU
MIGHT WANT TO CONSIDER?
THAT'S WHAT I'M GETTING AT.
BESIDES THAT ONE EXAMPLE.
THAT WE MIGHT WANT TO INCLUDE IN
RECOMMENDATIONS HERE.
IF NOT, I CAN MOVE ON.
MAYBE I'LL MOVE ON.
IF YOU THINK OF SOMETHING LET ME
KNOW.
A LOT OF QUIET.
NO ONE SAYING ANYTHING.
I CAN THINK OF A FEW THINGS, IN
TERMS OF A DRAFT OUR GROUP WILL
PUT SOMETHING TOGETHER AND YOU
CAN MAYBE THINK ABOUT IT.
LET'S MOVE TO OVERSIGHT,
SUPPORT, AND SECURITY.
THIS GETS INTO WHAT SORT OF --
WHAT CAN THESE VARIOUS
STAKEHOLDERS TO DO PROCEED
APPROPRIATE OVERSIGHT, THINK
WHAT YOU WOULD LIKE TO SEE
HAPPEN OR IF THERE ARE GAPS AT
YOUR INSTITUTION, SO, AGAIN,
SIMILAR TO THE PRIVACY AND
CONFIDENTIALITY QUESTION AS
WELL.
LOIS?
>> WELL, I FINALLY HAD A
THOUGHT.
>> OKAY, GREAT.
THANK YOU!
>> WITH RESPECT TO PRIVACY AND
CONFIDENTIALITY, IS THERE
INTENTION IN ASKING, YOU KNOW,
IN TRYING TO BE INCLUSIVE AND
TO, YOU KNOW, GET PEOPLE TO
SELF-IDENTIFY AS A MEMBER OF ONE
OF THESE COMMUNITIES?
INTENTION BETWEEN THAT AND BEING
ABLE TO PROTECT, IF THEY HAD AN
INTEREST IN BEING -- IN HAVING
THAT INFORMATION BE PRIVATE?
IN OTHER WORDS, IT SEEMS TO ME
PART OF THE -- I'M ASKING THIS
QUESTION.
SEEMS TO ME PART OF WHAT THE
PROJECT IS, WE WANT MORE
INCLUSIVITY, RIGHT?
AND SO TO GET THAT INCLUSIVITY,
THEN IN ALL KINDS OF RESEARCH,
YOU KNOW, NEIL WAS TALKING ABOUT
THE ONES WHERE MEMBERSHIP IN ONE
OF THESE COMMUNITIES MAY BE
SOMETHING THAT'S STUDIED, YOU
KNOW, AS FAR AS ANALYSIS GOES.
OTHER TIMES JUST FOR INCLUSION.
SO IF WE'RE -- IF WE'RE
ENCOURAGING RESEARCHERS, ARE WE
I GUESS IS THE QUESTION, IN
ORDER TO MEET THAT INCLUSIVITY
YOU'RE GOING TO COLLECT THIS
DATA BUT THEN YOU HAVE MORE DATA
COLLECTED THAT YOU HAVE TO
PROTECT.
IS THERE INTENTION THERE?
THAT'S MY QUESTION.
>> MAYBE LOIS, I'LL BUILD ON
WHAT I'M HEARING YOU SAY.
MAYBE BECAUSE THERE'S THIS
PATCHWORK OF APPROACHES TO THIS
RESEARCH AND HOW THE COMMUNITY
IS -- EACH STATE HAS DIFFERENT
APPROACHES, PATCHWORK OF LAWS
THAT CONSIDERATIONS MAY BE MADE
IN THIS, LIKE SUBPOENAING
RECORDS, FOR EXAMPLE, THAT MIGHT
SOMEHOW PUT THE LGBTQ COMMUNITY
AT RISK IN CERTAIN STATES WHERE
THAT WOULDN'T BE ALLOWED IN
OTHER STATES, IS THAT SOMETHING
THAT TOUCHES ON WHAT YOU'RE
SAYING, AM I FOLLOWING?
>> WHATEVER THE RISKS ARE.
MAYBE THAT WOULD BE HELPFUL TO
IDENTIFY WHAT THE RISKS ARE TO
BREACHES OF CONFIDENTIALITY AND
PRIVACY, OTHER THAN LEGAL BUT
OTHER KINDS OF -- WHAT ARE THE
RISKS ASSOCIATED WITH THAT?
AND DOES IT EVEN MATTER IF THERE
ARE RISKS OF HARM IF SOMEONE
DOESN'T WANT CERTAIN INFORMATION
TO BE, YOU KNOW, AVAILABLE TO
OTHERS.
AND THEN I'M JUST WONDERING IF
PART OF THIS PROJECT IS GOING TO
ENCOURAGE THE COLLECTION OF
DATA, SELF-IDENTIFIED, RIGHT?
BUT FOR PEOPLE IN RESEARCH GOING
TO ASK FOR CERTAIN KINDS OF
INFORMATION THAT MAYBE FOR
WHATEVER REASON THEY, YOU KNOW,
WANT TO KEEP CONFIDENTIAL, THEN
DOES THAT GO AGAINST -- SHOULD
THAT BE CONSIDERED IN WHAT KINDS
OF INFORMATION IS ORIGINALLY
SOUGHT?
DOES THAT MAKE SENSE?
ARE CONCERNS ABOUT
CONFIDENTIALITY AND PRIVACY ANY
DIFFERENT THAN THEY ARE ABOUT
ANY OTHER PIECE OF INFORMATION
THAT IS GIVEN BY PARTICIPANTS?
>> SIMILAR QUESTION, RIGHT?
I MEAN IF SOMEONE THOUGHT THE
INFORMATION WOULD BE
CONFIDENTIAL, AND THERE AREN'T
MEASURES IN PLACE TO PROTECT IT
I THINK IT'S THE SAME ISSUES FOR
OTHER -- FOR ALL TYPES OF
RESEARCH, THINGS WE STRUGGLE
WITH ALL THE TIME.
THERE ARE MEASURES IN PLACE.
ALREADY THINGS LIKE HIPAA,
THERE'S COC, OTHER THINGS THAT
HELP TO ADDRESS SOME OF THAT BUT
IT'S NOT FOOLPROOF, RIGHT?
THERE ARE GAPS POTENTIALLY.
POTENTIALLY.
THAT'S THE KIND OF THING THAT
WOULD PROBABLY GO IN A SECTION
LIKE THIS, TALK ABOUT WHAT IS
AVAILABLE NOW TO HELP
POTENTIALLY PROTECT SOME OF THIS
INFORMATION, BUT WHAT ARE SOME
OF POTENTIAL GAPS, HOW DOES THIS
SORT OF INTERSECT WITH STATE LAW
QUESTION, RIGHT?
IF YOU'RE IN A JURISDICTION
WHERE CERTAIN THINGS ARE
CRIMINALIZED, HOW CAN THAT BE
ADDRESSED, POTENTIALLY.
SORRY, LOIS.
>> JUST TO FOLLOW UP, I AGREE
WITH ALL THAT.
ADDITIONAL THING I'M WONDERING
ABOUT IS IS THE DRIVE TOWARDS
INCLUSION GOING TO ADD, IS THERE
A SUGGESTION HERE EXPECTATION
WOULD BE FOR RESEARCHERS TO ADD
MORE QUESTIONS ABOUT THESE
MEMBERSHIP IN ANY OF THESE
COMMUNITIES.
AND IS THAT -- YOU KNOW, IN ALL
RESEARCH, IS THAT KIND OF WHAT'S
ON THE TABLE, IN ALL RESEARCH?
OR IN ANY RESEARCH OR CERTAIN
KINDS OF RESEARCH?
AND THEN WHAT ARE THE BENEFITS
FOR ASKING THAT INFORMATION, IT
TELLS US WHETHER OR NOT TO
PEOPLE WHO ARE MEMBERS OF THESE
COMMUNITIES ARE INCLUDED, RIGHT?
IF YOU'RE CALLING FOR INCLUSION
WHAT'S YOUR MEASURE OF
INCLUSION?
AND IT SEEMS LIKE IT'S -- YOU
KNOW, DATA ABOUT PARTICIPATION
BY MEMBERS OF THESE COMMUNITIES
BUT THEN YOU'RE ASKING FOR
INFORMATION THAT THERE'S A
SUGGESTION IN HERE WITH RESPECT
TO PRIVACY AND CONFIDENTIALITY
THAT THEY HAVE HIGHER CONCERNS,
YOU KNOW, ABOUT THOSE ISSUES,
AND IT SEEMS LIKE IT'S AROUND
THOSE ISSUES, THE SUGGESTION IS,
AND SO, RIGHT, COLLECTING DATA
WHICH MAY NOT BE USED TO ADVANCE
SCIENCE, MAY, BUT MAY NOT, AND
THEN IS THAT INTENTION THEN AND
THEN YOU'RE GOING TO HAVE MORE
PRIVACY AND CONFIDENTIALITY
CONCERNS.
THAT'S THE QUESTION I'M RAISING.
>> THANK YOU.
ANOTHER QUESTION THAT CAN COME
UP ALSO IS IF CERTAIN
INFORMATION IS SHARED ABOUT
IDENTITY, HOW DOES THE RESEARCH
TEAM USE THAT DATA?
DO THEY ACCEPT THAT INFORMATION,
RIGHT?
OR DO THEY NOT?
I THINK THAT CAME UP IN THE LAST
SACHRP MEETING AGAIN, HOW DO YOU
ADDRESS THAT ISSUE AS WELL IN
TERMS OF THE -- THAT GETS BACK
TO THE RESEARCH CONDUCT AND
COLLECTION OF INFORMATION.
WHAT IS BEING COMMUNICATED IN
TERMS OF SELF-IDENTIFICATION
VERSUS HOW THAT INFORMATION IS
USED AND MIGHT BE CHANGED
POTENTIALLY, DEPENDING ON THE
RESEARCHER CONDUCTING THE
RESEARCH.
KEVIN AND THEN NEIL.
>> I THINK LOIS TOUCHED ON SOME
OF THE THINGS I WAS GOING TO
SAY.
I'M LOOKING AT THE PRIVACY,
CONFIDENTIALITY, OVERSIGHT,
SUPPORT AND SECURITY, SIMILAR
QUESTIONS AS LOIS.
YOU KNOW, WHAT ARE THE -- WHERE
ARE THE LEAKS, WHAT'S THE NATURE
OF THE LEAKS THAT WE'RE
CONSIDERING EXTRA MEASURES TO
ADDRESS BEYOND WHAT'S ALREADY
DONE, AND SO I'M HAVING A LITTLE
BIT OF TROUBLE TRYING TO GET
CONCRETE ANSWERS TO THOSE THINGS
BECAUSE I DON'T HAVE AS GOOD A
SENSE OF WHERE THINGS ARE
FALLING DOWN SO THAT ADDITIONAL
MEASURES ARE NEEDED.
I KNOW THE OVERSIGHT AND SUPPORT
DOESN'T SAY ADDITIONAL BUT
PRESUMABLY THAT'S IMPLIED
BECAUSE WE ALREADY HAVE
OVERSIGHT, SECURITY, ET CETERA.
>> OKAY.
NEIL?
>> SO I THINK A COUPLE THOUGHTS
THAT I THINK ARE IMPORTANT TO AT
LEAST HAVE A PLACE IN THIS
SECTION, ONE OF WHICH IS THAT
WHAT WE HEARD FROM, YOU KNOW, AT
LEAST IN THE PRIOR MEETING WAS A
DESIRE TO BE ASKED QUESTIONS,
RIGHT, ABOUT IDENTITY IN VARIOUS
FORMS, AND SO I THINK THAT
NOTION OF BOTH THE DEFAULT
NOTION THAT THESE ARE QUESTIONS
THAT INDIVIDUALS GENERALLY WANT
TO BE ASKED ABOUT BECAUSE THEY
ARE IMPORTANT PARTS OF WHO THEY
ARE AND THEY WANT THAT
REPRESENTED WITHIN STUDIES THEY
ARE PARTICIPATING AND THEY ARE
USED TO ANSWERING THESE
QUESTIONS ON A REGULAR BASIS IS
IMPORTANT DEFAULT BASELINE THAT
I THINK CAN PUSH IT A LITTLE BIT
AGAINST THE NOTION OF KIND OF
OVEREXTENSION OF PROTECTIONISM
IN THIS SPACE.
THE SECOND PIECE I THINK THAT'S
REALLY IMPORTANT THAT UNDERLIES
A LOT OF WHAT ALL OF US HAVE
BEEN SAYING IS JUST IN SOME
SENSE WE SHOULD REFLECT A BIT OF
A COMMITMENT TO TAILORING
OVERSIGHT AND PROTECTIVE
MEASURES TO ACTUAL DATA ON WHAT
RISKS AND VULNERABILITIES EXIST,
ANYTHING DONE SHOULD BE
APPROPRIATE FOR ACTUAL RISK THAT
MIGHT BE IMPORTANT RATHER THAN
SOMETIMES HAVING A REACTIONARY
OVEREXTENSION OF PROTECTION
BECAUSE OF PERCEIVED
VULNERABILITY.
WE HEARD A CLEAR MESSAGE THAT WE
SHOULD ASK PEOPLE QUESTIONS
ABOUT SEX AND GENDER IDENTITY,
THAT I THINK THERE'S A WAY IN
WHICH THAT NEEDS TO BE A BIT OF
AN ANCHOR IN SOME OF OUR
RECOMMENDATIONS.
>> OKAY.
THANK YOU, NEIL.
RUQAIIJAH?
>> YES, SO I WANT TO SAY YES, I
AGREE ABOUT WHAT WE HEARD IN
OCTOBER WHICH WAS THAT PEOPLE DO
WANT THIS INFORMATION COLLECTED,
AND THAT THE ACTUAL
VULNERABILITIES ARE LEGAL,
RIGHT?
THAT SOME JURISDICTIONS ARE
COLLECTING THAT INFORMATION, AND
THEN IT'S BEING USED IN WAYS
THAT HARM INDIVIDUALS.
SO, YES, I DO THINK THAT THERE
ARE ADDITIONAL PRIVACY AND
CONFIDENTIALITY MEASURES THAT
ARE REQUIRED HERE BUT I
DEFINITELY THINK THAT IT IS
BALANCED WITH THE FACT THAT
PEOPLE DO WANT THAT INFORMATION
OUT THERE TO BE USED.
AND SO I DO LIKE THIS.
I THINK IT GOES BACK TO THE
POINTS THAT ERIC MADE, THAT MAY
BE PUTTING IT TOGETHER IN OUR
RECOMMENDATIONS IS, AS NEIL
MENTIONED, GIVING SOME ACTUAL
INFORMATION WHICH COULD PICK UP
ON WHAT MINDY SAID EARLIER ABOUT
PARTICULAR INSTITUTIONS HAVING
SOME OF THESE ISSUES, RIGHT?
BUT STILL WANTING PEOPLE TO BE
ABLE TO SHARE THE INFORMATION
BECAUSE IT CAN HELP IN TERMS OF
A SCIENTIFIC DISCUSSION, RIGHT?
WE DON'T KNOW HOW ONE SEXUAL
ORIENTATION OR ACTIVITY IMPACTS
OUTCOMES BUT ALSO I THINK THE
BEST RESEARCH PRACTICES IS TO
HAVE AS MANY DIVERSE PEOPLE IN
RESEARCH, AND SO I THINK WE CAN
GET AT THAT IN THE
RECOMMENDATIONS.
>> THANK YOU.
ALLISON?
AND THEN NEIL.
>> I WANTED TO TAKE A MOMENT TO
GO BACK TO INFORMED CONSENT
BECAUSE I CAN'T BELIEVE I PASSED
UP THE OPPORTUNITY TO RANT ABOUT
MY FAVORITE THING TO RANT ABOUT.
WHICH IS WHEN YOU HAVE AN
INFORMED CONSENT FORM FOR A
STUDY THAT IS NOT FOCUSED ON,
YOU KNOW, THESE SEXUAL
MINORITY-FOCUSED ISSUES, WE
ALWAYS COME BACK TO THIS
BIOLOGICAL BINARY OF MALE OR
FEMALE, AND QUESTIONS OF CAN THE
PERSON GET PREGNANT, CAN THEY
NOT GET PREGNANT, IF YOU'RE A
MALE YOU HAVE TO DO THIS, IF
YOU'RE FEMALE YOU HAVE TO TAKE
THE PREGNANCY TEST, ET CETERA.
EVERY TIME I REVIEW ONE OF THESE
FORMS I'M ALWAYS CROSSING IT OUT
AND BEING LIKE, YOU KNOW, PERSON
CAPABLE OF PREGNANCY, ET CETERA.
SO I WOULD REALLY WANT TO
UNDERSCORE IN THIS SECTION THAT
WHEN WE'RE TALKING ABOUT
CONCERNS ABOUT PREGNANCY WE JUST
NEED TO GET RID OF COMMENTS
ABOUT MALE, FEMALE, OR ANY OF
THOSE THINGS AND JUST FOCUS ON
IT'S THE PREGNANCY WE'RE WORRIED
ABOUT, NOT WHAT YOUR GENDER
IDENTITY IS.
>> THAT TIES INTO THE CULTURAL
COMPETENCE PIECE, THE IDEA IN
TERMS OF EDUCATING ALL
STAKEHOLDERS, PEOPLE THAT WRITE
CONSENT FORM, REVIEWERS, WE NEED
TO PAY ATTENTION.
>> RANT OVER.
THANK YOU.
>> THANK YOU.
THAT'S AN IMPORTANT POINT.
>> KEVIN, DID YOU HAVE A
COMMENT?
>> I DIDN'T HAVE MY HAND UP.
>> OKAY.
>> I FAILED TO PUT MINE DOWN.
IT WASN'T UP.
>> ALL RIGHT, PERFECT.
ANYTHING ELSE ON - LAST QUESTION
IS ON REPORTING AND
DISSEMINATION OF FINDINGS.
ON THIS ONE IT'S FRAMED AS WHEN
WE'RE DOING IT, WHEN REPORTING
AND DISSEMINATING FINDINGS.
THIS ONE OF COURSE AS I THINK I
MENTIONED IF, WHEN, AND HOW,
UNDER WHAT CIRCUMSTANCES.
THERE'S A LOT ABOUT THIS IN
TERMS OF RETURNING INDIVIDUAL
RESULTS, AGGREGATE RESULTS,
TIMING, PROBABLY WE COULD
PROBABLY GET INTO IT A LITTLE
BIT HERE.
THIS QUESTION FOCUSES ON ALSO
SEEKING TO ENSURE THAT THE
REPORTING AND DISSEMINATION IS
TRANSPARENT AND IT ALSO -- TWO
SIDES, MISREPRESENTATION OF
INFORMATION AND THE ISSUE OF
INDIVIDUAL ANT COMMUNITY HARM.
ANYTHING HERE THAT YOU WANTED TO
DISCUSS OR TOUCH ON FOR
RECOMMENDATIONS?
TALKING ABOUT THE WHY AS WELL, A
LITTLE ABOUT THE HOW.
BUT AGAIN --
>> LINDA, WAS THERE A PARTICULAR
EXAMPLE YOU GUYS WORKING ON THIS
VERY CAREFULLY HAD IN MIND HERE?
LIKE A MISSTEP?
>> I THINK, YOU KNOW, WE LOOKED
AT SOME OF THE LITERATURE, SOME
OF THE STUDY EXAMPLES.
THERE ARE LOTS OF EXAMPLES OUT
THERE THAT REALLY GET INTO WHEN
YOU DISSEMINATE RESULTS HOW IT'S
BEING COMMUNICATED, LOOKING AT
COMMUNITY HARM FOR EXAMPLE.
LIKE YOU PUBLISH SOMETHING, HOW
IT'S PUBLISHED, HAVE YOU
CONSULTED WITH THE COMMUNITY ON
IT?
ARE THEY AWARE?
I THINK THAT'S WHAT I WAS
THINKING ABOUT.
IF YOU THINK ABOUT, YOU KNOW,
STUDIES OUT THERE WHERE THERE'S
BEEN SOME MISSTEPS, THOSE ARE
DIFFERENT AND REASONS FOR
MISSTEPS ARE DIFFERENT.
YOU MIGHT IMAGINE THAT THERE'S
RESEARCH THAT'S BEING DONE BY
LOTS OF DIFFERENT INVESTIGATORS
WITH MAYBE DIFFERENT VIEWPOINTS
ABOUT SOME OF THE THINGS WE'RE
TALKING ABOUT, AND THEN HOW THAT
INFORMATION IS BEING
DISSEMINATED, WAS THERE A
CONSULTATION WITH THE COMMUNITY
ON IT OR NOT AND HOW WE ADDRESS
THAT.
SO WE PROBABLY CAN FIND A NUMBER
OF CASE STUDY EXAMPLES TO ADD TO
THIS SECTION ABOUT HOW THERE
COULD BE INDIVIDUAL OR COMMUNITY
HARM, WHAT YOU MIGHT WANT TO DO
TO POTENTIALLY ENGAGE OR PARTNER
WITH THE COMMUNITY SO THAT
DOESN'T HAPPEN OR SOME OF THOSE
ISSUES MIGHT BE MITIGATED.
THAT'S I THINK WHAT THE GROUP
WAS INTENDING WITH THIS
QUESTION.
>> YEAH, AND HERE THERE ARE SOME
ANALOGOUS HELPFUL GUIDES THAT
HAVE JUST RECENTLY COME OUT
ABOUT THE USE OF POPULATION
DESCRIPTORS, IN PUBLICATIONS,
AND I KNOW THERE ARE SEVERAL
JOURNALS THAT ARE DEVELOPING
BEST PRACTICES WHEN TO USE
POPULATION DESCRIPTORS AND
TITLES AND TRYING TO MITIGATE
THE RISKS AROUND CONFLATION.
SO WE COULD PROBABLY POINT TO
SOME OF THOSE.
THE OTHER POINT GOES BAG UP TO
RESEARCH DESIGN, SOMEBODY
TOUCHED ON THIS BUT IN ITEMS OF
HARMONIZATION OF DATASETS AND
PROBLEMS THAT COME UP WHEN
RESEARCHERS MAKE DECISIONS HOW
TO SCALE UP IN TERMS OF OR TO
COMBINE DATASETS THAT HAVE BEEN
DESCRIBED DIFFERENTLY, THAT'S A
PLACE YOU CAN SEE THE ORIGINAL
INTENTIONS OF COMMUNITIES AND
INDIVIDUALS TO IDENTIFY
THEMSELVES GET LOST.
SO JUST BEING MINDFUL ABOUT THAT
HARMONIZATION PROCESS.
>> OKAY.
IN TERMS OF -- WE TALKED ABOUT
THE HARM PART.
THERE'S ALSO THE PIECE ABOUT
PROMOTING TRANSPARENCY, THAT
BUILDS TRUST IF YOU'RE
TRANSPARENT, YOU MIGHT WANT TO
THINK ABOUT THE FLIP SIDE AS
WELL IN THE RECOMMENDATIONS AS
WELL IN TERMS OF HOW THAT MIGHT
BE ACCOMPLISHED.
AGAIN, IF YOU'RE A COMMUNITY
ENGAGEMENT -- IF YOUR COMMUNITY
ENGAGEMENT HAS BEEN DONE IN A
WAY THAT YOU'VE ACTUALLY DONE
THAT, THAT WILL CERTAINLY HELP
WITH THIS PIECE AS WELL, GETTING
INPUT POTENTIALLY DEPENDING ON
THE STUDY.
IT MAY NOT BE APPROPRIATE FOR
EVERY STUDY BUT IN TERMS OF
DESIGN AND THE CONSENT PROCESS
AND ALSO IN TERMS OF REPORTING
DISSEMINATION OF FINDINGS,
THROUGHOUT THE LIFE CYCLE OF A
STUDY IS THE INTENT THERE.
OKAY.
SO, LET ME JUST ASK THIS
QUESTION.
DOES ANYBODY HAVE ANY GENERAL --
NOT LOOKING AT THE CHARGE
DOCUMENT OR JUST ANY SPECIFIC
QUESTION, ANYTHING, JUST IN
GENERAL, YOU AS A GROUP WOULD
LIKE TO SEE IN THE
RECOMMENDATIONS?
WE TALKED A LITTLE ABOUT
INCORPORATING SOME OF THE WHY,
WHICH MAKES SENSE.
AND THAT THE HOW CANNOT BE TOO
DETAILED BECAUSE THAT WOULD BE
DIFFICULT TO ACCOMPLISH.
IS THERE ANYTHING ELSE YOU WOULD
LIKE TO SEE?
AS WE TAKE THIS BACK AND START
DRAFTING.
KEVIN?
>> MAYBE WE GOT THIS DOWN IN THE
NOTES, BUT THE INTRODUCTION
MIGHT BE HELPFUL TO MAKE SURE
THAT WE'RE REALLY CLEAR ABOUT
THOSE DIFFERENT FUNCTIONS OF
INCLUSION THAT NEIL HAD SKETCHED
OUT AND CASES WHERE WE'RE
INVESTIGATING THE SCIENTIFIC
QUESTIONS, THE FOCUS ON LGBTQ+
COMMUNITY OR SCIENTIFIC
QUESTION, SUBANALYSES REGARDING
THAT, OR THERE'S A SPECIFIC
SCIENTIFIC QUESTION BUT THERE'S
MORAL JUSTIFICATION FOR SOME
LEVEL OF APPROPRIATE INCLUSION.
>> OKAY.
>> THINGS LIKE THAT, KEEPING
THOSE DISTINCTIONS IN MIND WILL
BE IMPORTANT FOR SOME OF THESE.
>> OKAY.
RUQAIIJAH?
>> YEAH, I WANT US TO THINK
ABOUT ARE THOSE DISTINCTIONS --
THEY ARE GREAT FOR US IN SORT OF
THE RECOMMENDATIONS, BUT CAN WE
EVEN MAKE THOSE DISTINCTIONS
HONESTLY?
RIGHT?
AND I THINK THE ISSUE BECOMES
THAT IT'S NOT JUST ABOUT SEXUAL
ORIENTATION BUT WHEN YOU HAVE
THE OTHER GROUPS THAT INTERSECTS
AND ASEXUAL THAT IT'S NOT JUST
ABOUT SEXUAL ORIENTATION, THAT
IT MIGHT BE ACTUALLY PART OF
BIOLOGY WITH THE INTERSECTS AND
HORMONES AND SO I THINK THAT
WHAT SANDRA WAS SAYING ABOUT
LOOKING AT THE NASEM REPORT MAY
BE VERY HELPFUL FOR US, AND
BEING ABLE TO CREATE SOME
LANGUAGE THAT ALLOWS FOR US TO
TALK ABOUT THE OVERLAP BETWEEN
WHEN IT IS A SCIENTIFIC
QUESTION, WHEN IT'S NOT A
SCIENTIFIC QUESTION, AND WHEN WE
DON'T KNOW BECAUSE I THINK THAT
WE DON'T KNOW WHEN IT IS A
SCIENTIFIC QUESTION AND WHEN
IT'S NOT.
AND WHAT WE'RE TRYING TO DO IS
PERHAPS INCREASE THE DIVERSITY
OF PARTICIPATION SO THAT WE
COULD FIGURE OUT THOSE ISSUES.
AND HOW THOSE ISSUES COULD BE
SOCIAL, THEY COULD BE
BIOLOGICAL, THEY COULD BE
POLITICAL, RIGHT?
IT COULD BE AN OVERLAP OF ALL OF
THOSE THINGS.
>> THANK YOU, RUQAIIJAH.
ANYTHING ELSE FROM ANYONE?
DAVID, YOU PROBABLY WANT TO GET
BACK TO YOUR TOPIC TOO.
SO ANY OTHER COMMENTS ON THIS
AND WE CAN -- I THINK WE HAVE A
LOT OF GOOD FEEDBACK.
JULIA, I DID HAVE A QUESTION FOR
YOU IN TERMS OF THAT EDIT,
WHETHER I SHOULD DO THAT NOW OR
WHETHER WE CAN -- OR WHETHER WE
CAN JUST DO THAT AFTER THE FACT.
IF YOU COULD CLARIFY THAT, THAT
WOULD BE HELPFUL BEFORE I END.
>> WELL, WHY DON'T WE DO IT NOW
SINCE WE HAVE THE TIME AND --
>> OKAY.
THIS IS WHAT THE SECTION WAS
THAT YOU HAD QUESTIONS ABOUT.
I'M TRYING TO LOOK AT MY NOTES
AS TO WHAT YOU HAD SAID.
>> YEAH, I THINK IT'S SOMETHING
MORE ALONG THE LINES CONSISTENT
WITH THESE PRINCIPLES, SACHRP --
SACHRP MAKES RECOMMENDATIONS ON
THE FOLLOWING, OR SOMETHING --
YOU KNOW, THERE'S BEEN
CONSIDERABLE INPUT ON THE CHARGE
SINCE IT WAS ORIGINALLY PROVIDED
BY OHRP SO I THINK THAT NEEDS TO
BE REFLECTED HERE, POINT BEING
IT'S NOT NECESSARILY NOW PURELY
DIRECTED FROM OHRP BUT HAS HAD
INPUT FROM THE SUBCOMMITTEES AND
FROM SACHRP, IT'S MORE ACCURATE
TO REFLECT THAT.
>> OKAY.
LET ME JUST -- GIVE ME JUST A
SECOND HERE.
>> SACHRP MAKES RECOMMENDATIONS
ADDRESSING THE FOLLOWING, OR WE
CAN REFINE THIS LATER BUT I WANT
TO MAKE SURE THAT EVERYONE
UNDERSTANDS THE POINT.
>> I HAVE A QUESTION, JULIA.
SO, DOES SACHRP JUST MAKE
RECOMMENDATIONS ON ITS OWN?
OR --
>> TYPICALLY NOT.
THE AGENDA FOR SACHRP IS SET BY
OHRP.
>> CAN WE SAY BUILDING ON THE
CHARGE FROM OHRP?
>> UH-HUH, YEAH, SOMETHING LIKE
THAT WOULD BE APPROPRIATE.
>> OKAY.
>> WE CAN REFINE IT BUT THAT'S
THE BASIC IDEA.
>> MY NEXT QUESTION GIVEN WHAT
WE JUST SAID EARLIER ABOUT THIS
CHARGE BEING ESSENTIALLY FINAL,
JULIA, IN TERMS OF THE
RECOMMENDATIONS TODAY, WOULD YOU
LIKE ME TO MAKE SOME EDITS HERE
OR SHOULD WE MAKE EDITS HERE?
>> WELL, I THINK GIVEN THE
DISCUSSION TODAY, I WOULD SAY
YES.
I MEAN, THIS WAS DISCUSSED AT
THE SUBCOMMITTEE LEVEL.
>> OKAY.
>> THEREFORE I THINK IT HAS TO
BE GIVEN THE OPPORTUNITY TO BE
DISCUSSED AT THE PARENT LEVEL.
>> OKAY.
>> THAT SAID --
>> SORRY.
>> WE'RE REACHING THE END,
FOCUS ON THE CHARGE.
>> I AGREE.
LET ME JUST GO AHEAD AND --
>> NOW, WERE YOU HOPING IN THE
TIME REMAINING TODAY, LINDA, TO
MOVE ON INTO DISCUSSION OF
THE -- BEGINNING DISCUSSION OF
THE RECOMMENDATIONS?
HOW WERE YOU -- WHAT WAS YOUR
VISION CONCLUDING TODAY?
>> I THINK BASED UPON WHAT I'VE
HEARD I'M NOT SURE -- IT'S UP TO
THE GROUP.
I'VE HEARD A LOT OF COMMENTS.
I THINK THERE'S A PATH FORWARD
FOR STARTING TO DRAFT THE
RECOMMENDATIONS.
SO UNLESS INDIVIDUALS ON THE
PARENT COMMITTEE HAVE -- WANT TO
ACTUALLY PROVIDE MORE SPECIFICS,
I THINK I WAS FINISHED FOR
TODAY.
>> OKAY.
>> I'M HAPPY BECAUSE I DO THINK
I HAVE ENOUGH TO START DRAFTING
BUT, AGAIN, I THINK THEY HAVE
PROVIDED SOME FEEDBACK FOR THE
RECOMMENDATIONS THEMSELVES.
WE HAVE MOVED BEYOND THE CHARGE.
JUST I THINK WE -- IN THE
BEGINNING I THINK IT WAS A
LITTLE BIT OF DISCUSSION ABOUT A
COUPLE THINGS GOING FORWARD.
>> YEAH, I UNDERSTAND.
TYPICALLY THE MODEL IS REACTING
TO A DRAFTED --
>> RIGHT.
>> A DRAFTED RECOMMENDATION AS
OPPOSED TO DRAFTING AT THE
MEETING LEVEL.
>> I WILL JUST -- WHAT I DID DO,
JULIA, I DID SEPARATE OUT THE
LAWS, REGULATIONS, GUIDELINES
FROM STANDARDS, I NEED WORD
SMITH THIS BULLET, I CAN DO THAT
AND THERE WAS ONE WORD CHANGE,
REPRESENT, A WORD THAT LOIS HAD,
I CAN CHANGE AS WELL.
BEYOND THAT, YOUR COMMENTS, I
THINK THE CHARGE WOULD BE FINAL.
WE'LL START DRAFTING.
I DON'T WANT TO CUT ANYONE OFF.
UNLESS YOU HAVE ANY OTHER
SUGGESTIONS OR COMMENTS FOR
TODAY I WAS GOING TO STOP WITH
WHAT I HAVE RIGHT NOW.
IS THAT OKAY WITH EVERYONE?
ALL RIGHT.
OKAY.
THANK YOU, JULIA.
>> SURE.
>> THANK YOU, LINDA.
THIS LOOKS GREAT.
>> YOU GOT PROBABLY WHAT YOU
NEED FOR THE SUBCOMMITTEE TO
DRAFT SOMETHING WHICH WE CAN
THEN REACT TO AT OUR NEXT
MEETING.
SO, AT THIS POINT WE WILL HEAD
BACK TO OUR BEST INTEREST
STANDARD PROJECT AND TURN IT
BACK OVER TO DAVID BORASKY WITH
REVISIONS.
OUR GOAL IF WE CAN GET THERE IS
VOTE ON A FINAL DOCUMENT TODAY
AND WE'LL SEE WHERE WE END UP.
>> WE'LL SEE.
WE'LL SEE.
IS MY SCREEN VISIBLE?
>> YES.
>> OKAY, GREAT.
SO, I'VE GONE THROUGH AND I'LL
START BY GOING BACK THROUGH ALL
THE PLACES THAT I'VE GOT SOME
EDITS.
THINGS THAT WERE CONSENSUS ON
STRIKING I'VE JUST ACCEPTED SO
THEY ARE NOT CLUTTERING UP THE
SCREEN ANYMORE.
SO, WHAT'S SHOWING ON MY SCREEN
IN BLUE ARE THINGS I EITHER
ADDED DURING THE BREAK OR THAT
WE ADDED WHILE TALKING.
SO I'LL JUST STOP AND SORT OF
LET PEOPLE SEE THIS.
A NUMBER OF MINOR CHANGES IN
PARAGRAPH 57.
AND THEN WHAT'S VISIBLE ON THE
SCREEN RIGHT NOW THESE ARE
CHANGES WE MADE WHEN WE WERE
DISCUSSING THIS BEFORE.
NOTHING BIG THERE.
I'VE ADDED THE BULLET WE AGREED
ON IN THE LAST DISCUSSION.
BUT LET'S JUMP TO THIS
PARAGRAPH.
THE OLD FIDUCIARY DUTY PARAGRAPH
AT 106.
SO, WHAT I'VE CUT OUT IN THIS
CASE I'VE LEFT THERE AND TRIED
TO WHITTLE IT DOWN SO IF WE'RE
NOT HAPPY WITH IT, IT'S FINE BUT
THIS IS SORT OF MY STAB AT
TRYING TO CLEAR THIS UP A LITTLE
BIT.
>> DAVE, CAN'T REMEMBER DO YOU
USE PATIENT SUBJECT ELSEWHERE IN
THIS DOCUMENT?
>> NO, DON'T BELIEVE SO.
>> I'D BE IN FAVOR OF JUST USING
SUBJECTS.
>> LOIS?
>> I MEAN, I THINK I WOULD JUST
GET RID OF THAT, STARTING OFF
THAT WAY, BECAUSE WHO IS GOING
TO DETERMINE -- IT'S SUGGESTING
SOMEONE IS GOING TO MAKE SOME
DETERMINATION.
MAYBE RESEARCHERS MAY SOMETIMES
HAVE THE DUTY OR IN SOME
CIRCUMSTANCES --
>> LET'S START --
>> SUCH AS IN CONTEXT OF
THERAPEUTIC RELATIONSHIP, COMMA,
RESEARCHERS MAY HAVE A DUTY TO
ENSURE -- MAY HAVE DUTY TO
FACILITATE TRANSITION.
I WOULD GET RID OF IF IT IS
DETERMINED.
>> YEAH, RIGHT.
>> I SEE WHAT YOU'RE DOING,
SORRY.
>> SO IMAGINE IT STARTS THERE.
>> RESEARCHERS MAY HAVE A DUTY,
MAY HAVE A DUTY TO TRANSITION
SUBJECT INTO OTHER, AND THEN
JUST -- AND PICK UP WHERE YOU
HAVE.
THAT MIGHT FIX IT.
I'LL SEE WHAT OTHER PEOPLE
THINK.
>> THERE IS REFERENCE TO
THERAPEUTIC RELATIONSHIP.
I WANT TO MAKE SURE EVERYBODY IS
COMFORTABLE MOVING THE WORD
"PATIENT," AND LIMITING TO
"SUBJECTS."
>> GOING BACK TO A PREVIOUS
COMMENT, CAN'T REMEMBER WHO, I
THOUGHT THE IMPORTANCE WAS THAT
THERE WAS THIS -- THE
RELATIONSHIP BETWEEN THE
INVESTIGATOR AND PARTICIPANT
SUBJECT, THAT WAS THE FOCUS,
LIKE THAT ACKNOWLEDGMENT, SO I
GUESS FOR ME, I STILL FEEL LIKE
IT'S REPETITIVE TO SEE 101, LINE
101, BUT THIS IS -- AGAIN, IF WE
FEEL LIKE WE WANT THIS, THAT'S
NINE.
BUT I HAVE A CONCERN ABOUT THE
WORD "DUTY," THAT PUTS A LOT OF
REQUIREMENT ON IT AND I WOULD
RATHER IT SAY MAY WANT TO
TRANSITION SUBJECTS.
A LOT OF DUTY TO PROTECT AND
DUTY TO DELIVER, DUTY TO -- YOU
KNOW, IT'S THE HIGHER, VERY HIGH
EXPECTATION TO ME.
I DON'T KNOW THAT THAT'S WHAT WE
WANT TO SAY.
>> I'LL THINK ABOUT WHAT ERIC IS
TALKING ABOUT.
TO MAKE SURE WHAT I WAS
SUGGESTING, DAVE, YOU WOULD
DELETE EVERYTHING FROM SUBJECTS
TO SUBJECTS.
>> YEAH, YEAH.
>> IN THE CONTEXT OF A
THERAPEUTIC RELATIONSHIP,
RESEARCHERS MAY HAVE A DUTY TO
TRANSITION SUBJECTS.
YOU THINK THAT'S TOO STRONG,
ERIC?
CONTEXT OF -- MAYBE OBLIGATED?
>> OR MAY WANT TO.
I DON'T KNOW THAT THEY WOULD --
AGAIN, I DON'T SEE HOW THAT'S
DIFFERENT THAN LINE 101C.
>> IT'S DIFFERENT IF IT'S
OBLIGATED, MAY WANT TO, IT'S THE
SAME.
>> I THINK REFERENCE TO THE
THERAPEUTIC RELATIONSHIP MAKES
IT MORE OF A DUTY.
>> IT'S NOT -- WE'RE NOT SAYING
THAT -- WE'RE NOT IMPOSING A
DUTY.
WE'RE SAYING IN SOME
CIRCUMSTANCES RESEARCHERS MAY
HAVE A DUTY.
KIND OF THE POINT IS KIND OF --
DON'T FORGET THAT AS YOU'RE
DOING THIS, IT'S IN THE BEST
INTEREST THAT ESPECIALLY I THINK
INSTITUTIONS NEED TO RESPECT
THAT INVESTIGATORS IN A
THERAPEUTIC RELATIONSHIP WITH
PATIENT SUBJECTS OR SUBJECTS,
WHATEVER WE WANT TO SAY, MAY
HAVE THIS DUTY.
NOT THAT -- IT'S APPROPRIATE TO
DO THIS, THAT'S DIFFERENT.
OR MAY WANT TO, IT'S VERY
DIFFERENT.
>> I'M TRYING TO PLAY THIS OUT
IN A PRACTICAL SITUATION.
LET'S SAY THE STUDY ENDS, RIGHT?
AND THIS PERSON DOESN'T HAVE ANY
OPTIONS FOR CARE.
THEY ARE INDIGENT.
WHAT'S THE DUTY HERE FOR
TRANSITION TO CARE?
I DON'T KNOW THE ANSWER TO THAT.
EVEN IF IT'S A THERAPEUTIC
RELATIONSHIP I DON'T KNOW THE
ANSWER TO THAT.
>> WELL, IF IT'S A THERAPEUTIC
RELATIONSHIP THEY CAN'T ABANDON
THEM.
THEY HAVE TO GIVE NOTICE AND
REFERRAL.
>> YEAH.
>> AND OPPORTUNITY TO SEEK CARE
ELSEWHERE.
THAT'S JUST A LEGAL DUTY, NOT
THAT WE NEED TO GET INTO THE
WEEDS ON THAT.
>> IT'S FINE.
IF THE COMMITTEE FEELS DUTY IS
THE RIGHT WORD, I'M IN THE
MINORITY HERE AND I'M OKAY WITH
THAT.
>> YEAH, I WOULD AGREE WITH
THAT.
>> IF WE GET TO THE BOTTOM AND
PEOPLE WANT TO SEE IT AGAIN I
CAN COME BACK UP TO IT.
OKAY.
SO, THIS RUQAIIJAH ON LINE 140,
THESE ARE NOT LIKE THE GREATEST
EXAMPLES ON EARTH BUT THEY WERE
SOME EXAMPLES OF WHAT MIGHT BE
DONE WITH SAMPLES OR DATA THAT'S
RETURNED TO -- FROM SPONSOR BACK
TO THE INVESTIGATOR.
AND THEN I LEFT THAT SCRATCHED
OUT BUT WE HAD AGREED TO DELETE
THAT.
ULTIMATELY HERE WE HAD THE
USUALLY KNOW -- OH, A LOT OF
THIS IS PRETTY MINOR.
THIS AGAIN I THINK WE AGREED ON
THIS, THIS LANGUAGE, FOR PART OF
6 ABOUT THE PLACEBO ASPECT.
NUMBER 8, ANOTHER ONE WHERE WE
HAD THERAPEUTIC RELATIONSHIP.
SO I'LL LEAVE THAT ONE UP FOR A
SECOND.
I TRIED TO COMBINE BOTH WHAT WE
WERE THINKING ABOUT AND ADDRESS
OHRP'S CLARIFICATION ABOUT WHAT
IT WAS THEY WERE ASKING.
>> I THINK THIS IS A GOOD
CHANGE.
I THINK YOU DID A NICE JOB SORT
OF MAKING THE POINT THAT
PRESERVATION OF THAT
RELATIONSHIP SHOULD NOT BE
(INDISCERNIBLE) FOR RESEARCH
PARTICIPATION, THE KEY POINT
THAT NEEDS TO BE THERE SO IT'S
GOOD.
>> OKAY.
AND THEN SO ALLISON, HERE I
DON'T KNOW IF THIS LITTLE
INSERTION SORT OF RESOLVES, YOU
KNOW, WHAT I THOUGHT WAS A FAIR
POINT YOU MADE ABOUT THE NATURE
OF CONTINUING TO COLLECT DATA.
>> YEAH, I'M OKAY WITH THIS.
>> YEAH, I STARTED TO WRITE MORE
ABOUT THE WHOLE LONG-TERM
MONITORING AND I WAS GOING TO
HAVE A REFERENCE TO, YOU KNOW,
THE CAR T GUIDANCE.
IT WAS GETTING TO BE A BIT TOO
MUCH SO I THOUGHT IF YOU DIDN'T
LIKE THIS I COULD SLAP THAT
STUFF BACK IN, BUT --
AND THEN, YEAH, THAT WAS SORT OF
IT, DOUG.
ERIC, IF YOU WANT TO SEE THAT
LANGUAGE HIGHER UP AGAIN.
>> NO, I'M GOOD.
>> OKAY.
>> SO THOSE ARE THE CHANGES THAT
HAVE BEEN MADE.
ARE THERE ANY OTHER ISSUES
COMMITTEE MEMBERS WANT TO RAISE
AT THIS POINT?
ARE WE HAPPY WITH THE DOCUMENT?
>> DAVE, I THINK YOU AND THE
COMMITTEE HAVE DONE A NICE JOB
WITH THE DOCUMENTS.
>> I APPRECIATE THAT ON BEHALF
OF THE COMMITTEE OF COURSE, YOU
AND RUQAIIJAH AND OTHERS AND
NEAL WITH PART OF THE
SUBCOMMITTEE DISCUSSIONS, WHICH
WERE HELPFUL, WORKING THROUGH
HERE IN THIS VENUE SO ...
>> ALL RIGHT.
THIS IS YOUR LAST CHANCE BEFORE
WE MOVE TO A VOTE.
ANY LAST CHANGES OR COMMENTS
PEOPLE HAVE?
OTHERWISE, I'M HAPPY TO
ENTERTAIN A MOTION TO APPROVE
THIS.
>> MOVE TO APPROVE.
>> I SECOND.
>> WE HAVE A MOTION AND SECOND.
WE'LL GO WITH A SHOW OF HANDS
AGAIN.
ALL IN FAVOR OF APPROVING THE
DOCUMENT?
I SEE NINE.
OPPOSED?
ZERO.
AND ANY ABSTENTIONS?
ALSO ZERO.
OKAY.
WELL, THAT WAS QUICKER THAN I
THOUGHT IT WOULD BE.
VERY NICE WORK ON THAT ONE,
DAVID.
>> THANKS, DOUG.
THANKS, EVERYBODY.
I APPRECIATE IT.
>> SO WE -- THE LAST ITEM IS
PUBLIC COMMENT.
WE HAVE NO PUBLIC COMMENTS.
SO WE ARE APPROACHING
ADJOURNMENT.
AND I WOULD JUST SAY IN CLOSING
OUR MEETING I DO WANT TO REMIND
EVERYONE THAT OUR NEXT MEETING
WHICH WILL ALSO BE VIRTUAL IS
SCHEDULED FOR JULY 23 AND 24.
I THINK I GOT THOSE RIGHT, JULIA
WILL LET ME KNOW IF I DIDN'T.
GOOD WORK TOGETHER.
WE APPROVED THE BEST INTEREST
STANDARD DOCUMENT.
AND I THINK WE PROVIDED LINDA
AND SUBCOMMITTEE WITH SOME
MATERIAL THAT THEY CAN MOVE
FORWARD WITH AND HAVE A DOCUMENT
FOR US TO TAKE A LOOK AT AT THE
JULY MEETING, IN ADDITION WE
WILL HAVE ONE OR TWO MORE TOPICS
TO TAKE UP AT THAT MEETING AS
WELL.
THANKS, EVERYBODY, FOR YOUR
WORK.
AS ALWAYS, MANY THANKS TO
MEMBERS OF THE SUBCOMMITTEE FOR
THE HUGE AMOUNT OF WORK THEY DO
BETWEEN OUR MEETINGS IN ORDER TO
ENABLE US TO DO THE WORK WE DO.
AND OF COURSE THE ENTIRE OHRP
STAFF AND JULIE IN PARTICULAR.
JULIE KANESHIRO, I DON'T KNOW IF
YOU WANT TO SAY ANYTHING IN
CLOSING?
>> NOT IN PARTICULAR, DOUG, BUT
JUST ECHOING THANKS TO ALL OF
YOU AND THE SUBCOMMITTEE'S
EXCELLENT WORK, AND GREAT
DISCUSSION TODAY.
SO THANKS SO MUCH.
>> AND JULIA, ANYTHING YOU WANT
US TO KNOW?
>> YOU KNOW, AGAIN, I WOULD NOT
EXPECT THAT JULY IS GOING TO BE
A ONE-DAY MEETING SO DO EXPECT
THE JULY 23 AND 24 IS GOING TO
BE A FULL ROBUST TWO-DAY VIRTUAL
MEETING.
BUT EVERYONE, PLEASE BEAR IN
MIND AND MAKE SURE YOUR
CALENDARS ARE MARKED FOR OCTOBER
22 AND 23, WHICH WILL BE AN
IN-PERSON MEETING.
OKAY, OCTOBER IS IN PERSON, SO
JUST BE CERTAIN YOU'VE GOT THAT
ON YOUR CALENDAR NOW.
OTHER THAN THAT, THANK YOU VERY
MUCH.
THAT'S IT.
>> HOPEFULLY WE'LL HAVE A COUPLE
NEW MEMBERS COME JULY.
>> HOPEFULLY.
>> THANKS AGAIN, EVERYBODY. 5312 03:42:20,293 WE'RE OFFICIALLY ADJOURNED.