LET'S OPEN THIS JULY MEETING OF
SACHRP.
I'M GOING TO BEGIN WITH ROLL
CALL, I'LL CALL EACH MEMBER'S
NAME IF YOU WOULD BRIEFLY
INTRODUCE YOURSELF, TELL US YOUR
INSTITUTIONAL AFFILIATION, THAT
WOULD BE GREAT.
LET'S START WITH MARY ELLEN.
>> GREETINGS, HAPPY TO BE HERE,
EVEN THOUGH IT'S VIRTUAL, MARY
ELLEN ALLEN, FORMER ASSOCIATE
GENERAL COUNSEL AT GENOTECH
ROCHE, NOW CONSULTANT IN LIFE
SCIENCES.
>> JODY.
>> JYOTI ANGAL, DIRECTOR OF
CLINICAL RESEARCH IN SOUTH
DAKOTA.
>> COLEMAN?
>> GOOD MORNING, LINDA COLEMAN,
DIRECTOR OF HUMAN RESEARCH
PROTECTION PROGRAM AT YALE
UNIVERSITY.
>> JANET FREEMAN-DAILY.
>> GOOD MORNING, LUNG CANCER
PATIENT ADVOCATE IN THE SEATTLE
AREA.
>> SANDRA LEE.
IS SANDRA HERE?
>> NO.
(INDISCERNIBLE).
>> GOOD MORNING, SKIP NELSON,
SENIOR DIRECTOR OF PEDIATRIC
DRUG DEVELOPMENT JOHNSON &
JOHNSON.
>> LOIS SHEPHERD.
>> PROFESSOR AT LAW, UNIVERSITY
OF VIRGINIA.
>> WALTER STRAUS.
>> GOOD MORNING, WALTER STRAUS,
VICE PRESIDENT OF CLINICAL
SAFETY AT MODERNA.
>> KEVIN LANGFORD.
>> GOOD MORNING, KEVIN LANGFORD,
PROFESSOR POPULATION HEALTH
SCIENCES DUKE UNIVERSITY.
>> CONSUELO WILKINS.
>> I'M THE CHIEF EQUITY OFFICER,
PROFESSOR OF MEDICINE AT
VANDERBILT UNIVERSITY MEDICAL
CENTER.
>> AND I'M ALSO PRESENT, DOUG
DIEKEMA FROM UNIVERSITY OF
WASHINGTON, SEATTLE CHILDREN'S
HOSPITAL.
JERRY, DO YOU WANT TO INTRODUCE
YOURSELF?
>> SURE, JERRY MENIKOFF, FROM
OHRP, DIRECTOR OF OHRP.
>> AND JULIE GREGORY.
>> DIFFERENCE OF POLICY PRACTICE
OHRP.
>> IF WE HAVE EX OFFICIO MEMBERS
PRESENT ANNOUNCE YOURSELVES.
>> GOOD MORNING.
DIRECTOR OF OFFICE OF CLINICAL
POLICY AT FDA.
>> KEVIN PROHSKA ASSOCIATE
DIRECTOR FDA.
>> AND DO WE HAVE ANY EX
OFFICIOS ONLINE WHO WANT TO
INTRODUCE THEMSELVES?
OKAY.
THANK YOU VERY MUCH.
THANK YOU FOR JOINING.
I'M DOUG DIEKEMA, CHAIR OF
SACHRP, AND IT IS SO GOOD TO
ACTUALLY FINALLY MEET MY
COMMITTEE IN PERSON, TO BE BACK
TOGETHER MOSTLY IN THE SAME
ROOM.
WE HAVE A BIG MEETING TODAY, AND
TOMORROW, WHERE WE WILL BE
TAKING ON A NUMBER OF ITEMS THAT
WE HOPE WE CAN ACHIEVE SOME
FINAL APPROVAL ON IN TERMS OF
GUIDANCE.
AND I JUST WANT TO RECOGNIZE
BEHIND THE SCENES DOING MUCH OF
THE HEAVY LIFTING ON THE SORT OF
DAY-TO-DAY WORK ON THE
STATEMENTS WE'RE GOING TO BE
TALKING ABOUT ARE TWO
SUBCOMMITTEES, OUR SUBCOMMITTEE
ON HARMONIZATION AND OUR SUBPART
A SUBCOMMITTEE, AND I WANT TO
RECOGNIZE THE GREAT AMOUNT OF
WORK THAT GOES INTO PREPARATION
FOR THESE MEETINGS.
WE HAVE REPRESENTATIVES OF BOTH
COMMITTEES HERE PRESENTING SOME
OF THOSE MATERIALS AND WE'LL
INTRODUCE THEM AT THAT TIME.
JERRY MENIKOFF, DO YOU WANT TO
SAY ANYTHING BEFORE WE GET
STARTED?
>> YES, THANK YOU, DOUG.
IT'S A GREAT PLEASURE TO ECHO
YOUR COMMENTS THAT WE'RE HAVING
SOMETHING CLOSE TO THE OLD
NORMALITY AGAIN.
WE'RE VERY HAPPY ON BEHALF OF
OHRP AND HHS TO BE PART OF THAT
PROCESS.
SO IT'S GREAT TO SEE PEOPLE HERE
IN PERSON AND BOTH PEOPLE WHO
ARE ONLINE.
I ALSO WANT TO ECHO, DOUG, YOUR
COMMENTS ABOUT ALL THE WORK THAT
LED UP TO THIS MEETING.
AND IN PARTICULAR, THE PEOPLE
WHO WORKED ON THE SUBCOMMITTEES,
THAT IS WHERE A MASSIVE AMOUNT
OF WORK IS REGULARLY DONE.
THE SUBCOMMITTEE CO-CHAIRS, WHO
ARE SORT OF IN CHARGE OF A GREAT
DEAL OF THIS WORK, COMMITTEE
MEMBERS, THE MEMBERS OF SACHRP
THAT INTERACT WITH THE
SUBCOMMITTEES, EX OFFICIOS,
MEMBERS OF FEDERAL AGENCIES THAT
ARE PART OF THIS PROCESS.
IT'S A MASSIVE AMOUNT OF WORK
AND WE REMAIN VERY, VERY
GRATEFUL FOR ALL THE EFFORT
PEOPLE HAVE PUT IN TO MAKE THIS
A REALITY.
I ALSO WANT TO THANK JULIA
GOREY, OUR OHRP, YOU KNOW,
INCREDIBLE VALUABLE COLLEAGUES
WHO OF COURSE VERY MUCH MAKE
THIS A REALITY.
YOU'RE A CRUCIAL PART OF THIS
PROCESS, JULIA, OF COURSE.
THANKS TO MEMBERS OF THE PUBLIC
FOR PARTICIPATING IN THIS.
I ALSO WANT TO JUST MENTION,
WE'RE VERY MUCH LOOKING FORWARD
TO THE WORK THAT'S GOING TO
OCCUR DURING THESE TWO DAYS,
SOME OF THAT WORK VERY DIRECTLY
RELATES TO WORK IN PARTICULAR
COMMENTING ON WORK OHRP HAS BEEN
DOING BEHIND THE SCENES IN TERMS
OF NEW GUIDANCE, REVIEWING OLD
GUIDANCE, ET CETERA, AND I WOULD
ENCOURAGE PEOPLE IF YOU HAVEN'T
BEEN TO OHRP'S WEB PAGE
RECENTLY, TAKE A LOOK AT THAT.
YOU'LL DISCOVER JUST
HIGHLIGHTING THE WORK OF THE
OTHER OHRP STAFF, OUR EDUCATION
DIVISION HAS BEEN BUSILY
OVERTIME CREATING MORE AND MORE
VIDEOS AND OTHER THINGS THAT ARE
VERY USER FRIENDLY THAT COULD
HELP PEOPLE UNDERSTAND THE
REGULATIONS.
OUR POLICY DIVISION HAS BEEN
VISIBLY OVER TIME PRODUCING
GUIDANCE, FAQs, ET CETERA.
SO TAKE A LOOK, YOU MAY DISCOVER
THERE'S SOME GUIDANCE ON SOME
TOPIC THAT'S VERY HELPFUL TO
YOU.
ALSO MENTION OUR COMPLIANCE
DIVISION, DOING A NUMBER OF
THINGS, SOME OF THOSE THINGS ARE
WORKS IN PROGRESS DUE TO THE
NATURE OF COMPLIANCE UNTIL WE
REACH A CERTAIN POINT WE DON'T
GO PUBLIC BUT I JUST WANT --
EVERYBODY SHOULD BE AWARE OF ALL
OF THAT WORK.
AGAIN, WE'RE REALLY LOOKING
FORWARD TO THESE TWO DAYS, AND
I'LL HAND IT BACK TO DOUG.
>> THANKS, JERRY.
WE'LL HAVE AN OPPORTUNITY TO
HEAR FROM YVONNE LAU A LITTLE
LATER IN THE DAY ABOUT SOME OF
THE INITIATIVES IN THE
DEPARTMENT OF EDUCATION WHICH WE
CAN LOOK FORWARD TO.
OUR FIRST ORDER OF BUSINESS IS
TO APPROVE MINUTES FROM MARCH 10
AND 11 MEETING EARLIER THIS
YEAR, CAN I GET A MOTION TO
APPROVE THOSE MINUTES?
>> SO MOVED.
>> IS THERE A SECOND?
>> SECOND.
>> ANY COMMENTS OR AMENDMENTS TO
THOSE MINUTES?
SEEING NONE, ALL IN FAVOR OF
APPROVAL?
>> AYE.
>> AND ANYONE OPPOSED?
ANYBODY ABSTAIN?
OKAY.
THE MINUTES ARE APPROVED.
ALL RIGHT.
NEXT ITEM OF BUSINESS IS TO
REVIEW OHRP DRAFT GUIDANCE ON
THE USE OF SINGLE INSTITUTIONAL
REVIEW BOARDS FOR COOPERATIVE
RESEARCH, AND WE HAVE BOTH OF
OUR -- TWO SUBCOMMITTEE CHAIRS
HERE TO PRESENT THAT.
DAVID BORASKY I BELIEVE IS GOING
TO SORT OF PRESENT THIS, AND
MARK BARNES IS HERE AT THE TABLE
TO ASSIST WITH THAT.
I'LL LET YOU TWO INTRODUCE
YOURSELVES AND MOVE FORWARD.
>> THANKS, DOUG.
LET ME JUST MAKE SURE -- YEAH.
I'LL INTRODUCE MYSELF.
DAVID BORASKY, VICE PRESIDENT
ARE COMPLIANCE WCGIRG, CO-CHAIR
OF THE SUBPART A SUBCOMMITTEE,
OFTEN THESE DOCUMENTS ARE GIVEN
TO ONE COMMITTEE OR THE OTHER
BUT WE OFTEN END UP DOING
OVERLAPPING WORK SO THIS
DOCUMENT WAS CO-AUTHORED BY
MYSELF AND MARK BARNES WHO WILL
PARTICIPATE IN DISCUSSIONS, AND
HE'S AT THE TABLE TODAY AS WELL.
I THINK I'VE GOT THIS PULLED UP,
IT SAYS I'M STILL SHARING THE
SCREEN SO HOPEFULLY EVERYBODY
CAN SEE IT.
APOLOGIES THAT I'M SPEAKING TO
THE BACKS OF SOME OF YOU, THE
WAY THE ROOM IS ARRANGED,
ALTHOUGH I DIDN'T ARRANGE IT.
THIS DOCUMENT IS THE
SUBCOMMITTEE'S PROPOSED RESPONSE
TO THE RECENTLY RELEASED
GUIDANCE ON SINGLE IRB REVIEW
THAT HAS COME OUT OF OHRP.
>> EXCUSE ME.
SORRY TO INTERRUPT.
WE'RE NOT SEEING YOUR SLIDES ON
ZOOM.
>> OH, HOLD ON A SECOND.
LET'S SEE, YOUR SCREEN SHARING
IS PAUSED.
>> JANET, THERE ARE NO SLIDES.
THERE'S TEXT.
>> YES, ARE YOU SEEING THE TEXT?
>> NO, WE JUST SEE THE INTRODUCE
SLIDE FOR THE MEETING.
>> OKAY.
JUST A MOMENT.
>> THE GUARDIAN ANGEL IS
APPROACHING.
[LAUGHTER]
>> THERE WE GO.
THANK YOU.
>> ALL RIGHT.
USUALLY AFTER TWO OR THREE YEARS
OF ZOOMING AND FACETIMING AND
EVERYTHING YOU WOULD THINK I
WOULD HAVE THIS FIGURED OUT.
REGARDLESS, WE'VE GOT THIS
GUIDANCE, THE DRAFT GUIDANCE WAS
RELEASED RECENTLY, AND SACHRP
HAS BEEN ASKED TO MAKE COMMENTS
ON THAT.
YOU KNOW, IN TERMS OF THE
SUBCOMMITTEES, WE WERE EXCITED
TO SEE THIS GUIDANCE, AS IT'S
NOTED IN THE DOCUMENT THE SINGLE
IRE MANDATES STARTED WITH THE
NIH A FEW YEARS AGO, AND THEN IT
WAS PUT INTO THE COMMON RULE FOR
RESEARCH UNDER THE COMMON RULE
MANDATING THE USE OF SINGLE IRB
REVIEW FOR A LOT OF MULTI-SITE
RESEARCH.
THE CONCEPT ITSELF ISN'T NEW.
LOTS OF FDA MULTI-SITE STUDIES
HAVE GONE ON FOR DECADES BUT
THIS REPRESENTED A CATCHING UP
ON THE COMMON RULE SIDE OF THE
HOUSE.
AND WHY THE GUIDANCE IS NEEDED,
EVEN THOUGH IT'S BEEN OCCURRING
IN THE CONTEXT OF MULTI-SITE
INDUSTRY SPONSORED CLINICAL
TRIALS FOR DECADES THE GUIDANCE
IS NEEDED BECAUSE UNDER THE NEW
MANDATE LOTS OF INSTITUTIONS
THAT ARE USED TO BEING AN
INSTITUTIONAL LOCAL IRB ARE NOW
TASKED WITH BEING APPOINTED OR
BEING PART OF A PROGRAM THAT IS
GOING TO REVIEW FOR MULTIPLE
SITES.
AND THERE WASN'T REALLY A LOT OF
EXISTING GUIDANCE OUT THERE.
THE ORGANIZATIONS THAT WERE
DOING IT BEFORE JUST SORT OF
GREW UP DOING IT.
AND SO THE GUIDANCE HAS THE
OPPORTUNITY TO BE VERY HELPFUL
TO THAT SEGMENT OF THE IRB WORLD
THAT IS WADING INTO THESE WATERS
FOR THE FIRST TIME TRYING TO
FIGURE OUT HOW TO MAKE IT ALL
WORK IN A WAY THAT PROVIDES THE
SORT OF EFFICIENCIES TO THE
PROCESS THAT THE REGULATION WAS
HOPING TO ACHIEVE AND NOT
CREATING ADDITIONAL NEW BARRIERS
TO TAKE THE PLACE OF ANY OF THE
THINGS THAT WERE PART OF THE OLD
SYSTEM.
>> DAVID, I'M GOING TO
INTERRUPT.
I DON'T KNOW IF THERE'S A WAY TO
PUT THE MICROPHONE SO THEY ARE
MORE STRAIGHT UP.
I'M GETTING MESSAGES ON THE
PUBLIC FEED YOU'RE FAINT.
I.T. PEOPLE, IF THERE'S A WAY
YOU CAN INCREASE HIS VOLUME THAT
WOULD BE --
>> I COULD STAND CLOSER.
>> I'M SORRY FOR INTERRUPTING.
>> NO, THAT'S OKAY.
IT'S GOOD FOR THE PEOPLE WHO ARE
ONLINE AND HAVING TO LISTEN TO
BE ABLE TO HEAR ME AND
PARTICIPATE IN THE DISCUSSIONS.
WE HAVE THIS DOCUMENT THAT MARK
TOOK THE LEAD ON AUTHORING BUT
IT WENT THROUGH THE
SUBCOMMITTEES, PART OF THE
CHALLENGE FOR TODAY DOUG
MENTIONED SEVERAL ITEMS FOR THE
SACHRP MEETING THAT ARE TIME
SENSITIVE.
THIS IS OPEN COMMENT PERIOD.
MARK AND I HOPE THAT WE'LL NOT
ONLY GET GOOD FEEDBACK TODAY BUT
HAVE THIS IN A FINAL DONE FORM
BY THE END OF THE MEETING IF NOT
TODAY THEN TOMORROW.
THAT'S WHY IT'S ON THE AGENDA
TODAY EARLY AS WELL.
AND SO WHAT WE'LL BE DOING IS
GOING THROUGH THIS DOCUMENT, AND
REQUESTING FEEDBACK AND LOOKING
FOR AREAS TO IMPROVE IT AND I
THINK -- I'M GOING TO SEE IF THE
TRACKING IS ON.
IF NOT I'LL TURN THAT ON IN A
MINUTE.
AND SO AT A HIGH LEVEL THAT'S
THE BACKGROUND, MARK.
I DON'T KNOW IF YOU HAVE
ANYTHING TO ADD WHILE I FIGURE
OUT HOW TO --
>> NOT REALLY, DAVID.
ARE YOU GOING TO GO THROUGH LIKE
THE PRIMARY FEATURES OF OUR
COMMENTS?
YES.
>> GREAT.
>> I'LL TURN ON TRACK CHANGES,
LET ME GET THAT.
SO, IN THE REFLECTIONS FROM THE
SUBCOMMITTEE, WHEN LOOKING AT
THIS DOCUMENT, WE BELIEVE THAT
THERE ARE APPROXIMATELY FIVE
AREAS THAT CAN BENEFIT FROM --
THAT -- AREAS FOR IMPROVEMENT TO
DOCUMENT TO MAKE IT MORE USEFUL
FOR THE COMMUNITY OF FOLKS THAT
WILL BE USING THIS AS A GUIDANCE
DOCUMENT.
AND ALSO TO REALLY HELP THE
COMMUNITY ACHIEVE THE GOALS OF
WHAT COULD BE ACCOMPLISHED
THROUGH SINGLE IRB REVIEW AND
ELIMINATING SOME OF THE CONCERNS
THAT WE HAD, ONE, WE'VE EITHER
EXPERIENCED IN THE
IMPLEMENTATION OF SINGLE IRB OR
THAT WE THOUGHT WERE POSSIBLE
OUTCOMES FROM THE WAY THE
DOCUMENT'S CURRENTLY WRITTEN.
AND SO THERE ARE AREAS OF LOCAL
CONTEXT, WHAT THAT MEANS, HOW
THAT'S TO BE INTERPRETED BY THE
IRB COMMUNITY.
WE HAVE QUESTIONS OR COMMENTS
ABOUT THE ROLE OF THE LOCAL
IRBs AT THE SITES THAT CEDED
REVIEW TO THE IRB AND WHAT THAT
ROLE SHOULD BE, WITH A CONCERN
THAT, AGAIN, WE DON'T WANT TO
HAVE A SYSTEM THAT SAYS SINGLE
IRB BUT LOCAL IRBs ARE CHIMING
IN.
WE THINK IT WILL BENEFIT FROM
DEFINING ROLE OF THE SINGLE IRB
AND ROLE CEDED TO THE IRB,
INTERWEAVING WITH QUESTIONS
ABOUT LOCAL CONTEXT.
ANOTHER POTENTIAL AREA FOR
CLARIFICATION HAS TO DO WITH
ISSUES AROUND COMPLIANCE, AND
WHO IS IN THE DRIVER'S SEAT WHEN
A COMPLIANCE ISSUE ARISES AT AN
INSTITUTION THAT HAS CEDED
OVERSIGHT TO A SINGLE IRB AND
HOW DOES THE SINGLE IRB INTERACT
WITH THOSE LOCAL SITES IN
MANAGING AND CONCLUDING ANY
INVESTIGATIONS OR ISSUES RELATED
TO COMPLIANCE.
SO THAT'S CERTAINLY AN AREA FOR
IMPROVEMENT.
OR AN AREA WHERE MORE CLARITY
WOULD BE HELPFUL TO THE
COMMUNITY, AND THEN WE ALSO
SPENT TIME TALKING ABOUT ANOTHER
ASPECT OF LOCAL CONTEXT WHICH
ARE STATE LAWS.
ONE OF THE CHALLENGES TO OUR
CURRENT SYSTEM IS THAT IN
ADDITION TO FEDERAL REGULATIONS
THERE ARE A NUMBER OF STATES
WITH RESEARCH-SPECIFIC LAWS THAT
MUST BE FOLLOWED AT VARIOUS
SITES, IN MULTI-SITE STUDIES ARE
OFTEN CROSSING STATE LINESES IF
YOU HAVE A SINGLE IRB IN
WASHINGTON STATE OVERSEEING
RESEARCH IN NEW YORK OR VIRGINIA
THERE MAY BE LAWS THAT THEY HAVE
TO BE AWARE OF OR UNDERSTAND HOW
TO IMPLEMENT.
AND SO, YOU KNOW, THE DOCUMENT
WAS FAIRLY SILENT ON THAT, BUT
WE HAVE RECOMMENDATIONS FOR HOW
THAT MIGHT BE ADDRESSED AND WHAT
CAN BE DONE TO FACILITATE THAT
ASPECT OF COMPLIANCE WITH STATE
AND LOCAL LAWS.
AND I THINK THOSE ARE THE MAIN
BUCKET AREAS THAT WE'VE
ADDRESSED IN THIS DOCUMENT.
>> I WOULD JUST A COUPLE
COMMENTS.
DAVID, ONE IS THERE'S ALSO --
>> YOUR MIC IS OFF.
YOUR LIGHT IS NOT ON.
>> IT IS ON.
>> OH, OKAY.
>> ONE IS THAT WE ACTUALLY
ADDRESS HERE THE ISSUE OF
DEFINING ALLOWABLE -- CRITERIA
FOR ALLOWABLE EXCEPTIONS TO THE
SINGLE IRB REQUIREMENT, AND NEED
TO DEFINE WHAT CRITERIA OUGHT TO
BE FOR DETERMINING THAT SINGLE
IRB IS NOT APPROPRIATE FOR A
FEDERALLY FUNDED FEDERALLY
SUPPORTED STUDY.
AND THE -- SO THERE'S THAT AS
WELL, IN THE LAST PART OF THIS
DRAFT.
THE OTHER THING THAT JUST TO BE
CLEAR, THAT THIS COMMITTEE,
SACHRP, AND THE SUBCOMMITTEES
FOUR YEARS AGO MADE COMMENTS
ABOUT THE SINGLE IRB REQUIREMENT
AND THAT ARE LARGELY -- THESE
ARE LARGELY CONSISTENT WERE
MARCH 2018 COMMENTS.
AND SO THIS COMMITTEE IS ON
RECORD ABOUT THESE ISSUES FROM
BEFORE, AND I WOULD -- IF I WERE
YOU AS I LOOKED AT CERTAINLY WE
ON THE SUBCOMMITTEES AS WE
LOOKED AT THIS AND TRIED TO
DRAFT THESE THINGS WE WERE
MINDFUL OF TRYING TO CONTINUE
THE SAME THEMES AND POINTS OF
VIEW ARTICULATED FOUR YEARS AGO.
>> AND SINCE THEY WERE FOUR
YEARS AGO THEY WERE ATTACHED TO
THE DOCUMENT SO YOU HAD A CHANCE
TO SEE THOSE.
I THINK MANY OF YOU WERE NOT ON
THE SACHRP FOUR YEARS AGO.
SO THANKS, MARK, FOR THAT
ADDITIONAL CONTEXT.
SO, WITH THAT, I THINK WE CAN
START GOING THROUGH THIS
DOCUMENT AND HOPEFULLY MAKE SOME
PROGRESS IN GETTING THIS INTO A
STATE THAT ALL OF YOU FIND
ACCEPTABLE.
AND I WILL, AS I'M GOING THROUGH
THIS, WILL DO MY BEST TO WATCH
THE FOLKS ON THE SCREEN FOR
RAISED HANDS.
THAT FUNCTION SHOULD WORK.
I DON'T THINK -- I'M NOT GOING
TO -- I'LL LET SOMEBODY ELSE
WATCH THE CHAT.
THAT'S TOO DISTRACTING.
THE BACKGROUND IS WHAT IT IS.
AND WE'RE TALKING ABOUT
OBVIOUSLY THIS IS JUST THE
BACKGROUND FOR HOW WE GOT HERE,
STARTING WITH NIH POLICY IN
2016, AND THE IMPLEMENTATION OF
THE FINAL RULE THAT PUT IN THE
SINGLE IRB REQUIREMENT IN PLACE.
AND RIGHT HERE IN THE BEGINNING
AS MARK NOTED, THERE ARE SOME
BUILT-IN EXCEPTIONS TO THE
REQUIREMENT THAT ARE BUILT INTO
THE REGULATIONS THEMSELVES,
RESEARCH REQUIRING REVIEW BY,
FOR EXAMPLE, TRIBAL IRB OR FOR
FOLLOWING TRIBAL LAW AND THEN
SORT OF A CATCH-ALL RESEARCH
THAT THE DEPARTMENT OR AGENCY
CONDUCTING SAYS A SINGLE IRB IS
NOT APPROPRIATE.
SO, MORE ON THAT LATER AS WE GET
TO THAT SECTION OF IT.
AND IT'S ALSO NOTED IN HERE
THAT, YOU KNOW, THE FDA DOES NOT
HAVE A SIMILAR REQUIREMENT BUT
HAS BEEN FAIRLY COMMON IN
INDUSTRY-SPONSORED MULTI-SITE
RESEARCH TO USE SINGLE IRBs,
BUT THAT'S CURRENTLY AN AREA
WHERE THERE'S NOT HARMONIZATION
BETWEEN THE FDA REGULATIONS AND
COMMON RULE.
THE DISCUSSION STARTS WITH
FURTHER BACKGROUND, WHAT IS
HISTORY OF IRBs, THEY WERE
INSTITUTIONALLY BASED, SET UP TO
REVIEW RESEARCH AT THAT
INSTITUTION.
AND, YOU KNOW, THAT DOES HAVE
ITS OWN STRENGTHS IN MANY WAYS,
THOSE ARE NOTED IN THE DOCUMENT,
FAMILIARITY WITH THE LOCAL
CONTEXT IN TERMS OF THE
INSTITUTION ITSELF, RESEARCHERS
THAT WORK THERE, FAMILIARITY, IF
YOU WILL, THAT A SINGLE IRB
WOULD NOT SORT OF INTUITIVELY
HAVE BECAUSE THEY ARE NOT
LOCATED AT THAT LOCATION.
AND THEN OBVIOUSLY NOT ONLY ON
THE FRONT END ARE THEY ABLE TO
HAVE A FAMILIARITY WITH LOCAL
POLICIES AND PROCEDURES, LOCAL
RESEARCHERS, BUT THEY ARE ON
SITE.
AND BEING INSTITUTIONAL BASED,
THEY ARE IN A GOOD POSITION TO
MONITOR THE RESEARCH FOR IRBs
THAT HAVE TAKEN THAT ON AS A
COMPONENT OF THEIR WORK.
AND HAVE MORE READY ACCESS TO
INVESTIGATORS, TO RECORDS, TO
TEAM MEMBERS, ET CETERA.
AND WE JUST CALL THAT OUT
BECAUSE I THINK, YOU KNOW, I
DON'T THINK THERE'S ANY DEBATE
THAT THAT'S INDEED THE CASE, AND
THEY -- AS NOTED IN THE
PARAGRAPH STARTING AT LINE 47,
YOU KNOW, THAT IS PART OF THE
CONTEXT IN WHICH WE LOOK AT THE
SINGLE IRB CONCERNS AND IN FACT
IT IS PART OF WHAT MAKES THE
GUIDANCE -- HIGHLIGHTS NEED FOR
GUIDANCE AND POINTS THAT HELP
MAKE THE GUIDANCE I THINK
HELPFUL IS THAT THEY CAN HELP
ADDRESS OR HELP THE COMMUNITY
UNDERSTAND HOW TO SORT OF TREAD
THOSE PATHS AND DO SO
EFFECTIVELY.
SO, I'LL MOVE INTO THE LOCAL
CONTEXT SECTION.
IF PEOPLE HAVE COMMENTS OR
QUESTIONS, JUST RAISE YOUR HAND
AND I'LL DO MY BEST TO SORT OF
WATCH FOR THOSE ON THE SCREEN AS
WELL AS IN THE ROOM.
LOCAL CONTEXT IS THE FIRST BIG
-- THE BIG BUCKET OF COMMENTS WE
HAVE HERE.
YOU KNOW, THIS NOTION OF LOCAL
CONTEXT IS THE IDEA OF IRBs
HAVING ADEQUATE KNOWLEDGE OF THE
LOCAL CONTEXT WHERE THE RESEARCH
WILL TAKE PLACE.
AS MENTIONED A ABOVE, IT WAS AT
THE INSTITUTION AND HAD A GOOD
SENSE OF WHAT THE CONTEXT WAS
AND WHERE THINGS LIKE, YOU KNOW,
LOCAL LAW WOULD COME INTO PLACE,
LOCAL IRB WOULD IN THEORY HAVE A
GOOD UNDERSTANDING OF THAT PART
OF THE LOCAL CONTEXT.
WHAT WE START TALKING ABOUT AT
LINE 64 IS SUPPLEMENTING DRAFT
GUIDANCE WITH ADDITIONAL
LANGUAGE ABOUT HOW THE SINGLE
IRB SHOULD TAKE LOCAL CONTEXT
INTO ACCOUNT, AND WHEN THE LOCAL
CONTEXT SHOULD PREVAIL AS
DETERMINANT IN THE APPROVAL
DECISION FOR PROPOSED STUDY.
AND WE HAVE AN EXAMPLE HERE OF
MULTI-SIDE SOCIAL BEHAVIORAL
STUDY ON PSYCHOLOGICAL
COUNSELING INTERVENTIONS FOR
TRANSGENDER TEENAGERS AND HOW
THAT THE ISSUES AND IMPLICATIONS
MAY DIFFER SUBSTANTIALLY AT
DIFFERENT SITES DEPENDING ON
THEIR LOCATION AND THE
ENVIRONMENT IN WHICH THEY ARE
LOCATED.
AND, YOU KNOW, THE SCENARIO,
THAT RAISES A NUMBER OF
INTERESTING OR CHALLENGING
POINTS THAT WOULD HAVE TO BE
WORKED THROUGH IN THE SINGLE IRB
CONTEXT, AND SO WE THINK THE
GUIDANCE IS AN OPPORTUNITY TO
TAKE EXAMPLES LIKE THAT AND
ELABORATE FURTHER ON WHETHER OR
NOT SINGLE IRB WOULD BE
APPROPRIATE IN THE
CIRCUMSTANCES, AND ANY COMMENTS
ON THAT FIRST LONGER PARAGRAPH
AT LINE 64?
>> I HAVE A QUESTION.
>> SURE? SO WHO .
>> WHO WOULD INITIATE LOOKING
INTO WHETHER OR NOT THE SINGLE
IRB WOULD BE APPROPRIATE IN THAT
CONTEXT, WOULD IT BE THE
INSTITUTION, FUNDER,
INVESTIGATOR, WHO WOULD THAT BE?
>> I DON'T KNOW IF YOU HAVE
THOUGHTS, MARK.
>> I THINK IT'S ALL OF THE
ABOVE, I THINK THE INVESTIGATOR
AS A RESPONSIBILITY TO THINK
ABOUT WHETHER THE SINGLE IRB IS
APPROPRIATE OR NOT APPROPRIATE
FOR THE STUDY, ESPECIALLY FOR
MULTI-SITE STUDY.
THIS PARAGRAPH PROPOSES OR
POSITS COULD BE IN WIDELY
VARYING GEOGRAPHIC AREAS WITH
VARYING RESOURCE ALLOCATIONSES
AVAILABLE FOR THESE KIDS
ENROLLED.
IT'S ALSO THE INSTITUTION WHERE
THE INVESTIGATOR IS LOCATED
BECAUSE THE OFFICIAL AND
HIERARCHY, HRPP, HAS AN
OBLIGATION, PLENARY OBLIGATION
TO MAKE SURE THE RESEARCH IS
BEING DONE APPROPRIATELY.
THE FUNDER WOULD BE -- HOPEFULY
THE FUNDER WHEN IT FUNDED THE
PROPOSED STUDY WOULD THINK ALONG
THE SAME LINES, IF THE FUNDER IS
A FEDERAL AGENCY HOPEFULLY IT
WOULD BE THINKING ALONG THOSE
LINES AS WELL.
ANY OF THOSE ENTITIES COULD
BRING IT UP, AND THE LOCAL SITES
IN A MULTI-SITE STUDY SHOULD BE
TALKING ABOUT WHETHER THEY THINK
THEY WANT TO SUBJECT THEMSELVES
TO REVIEW WHEN THEY BELIEVE THEY
HAVE UNIQUE LOCAL CIRCUMSTANCES
THAT MIGHT NOT BE TAKEN INTO
ACCOUNT.
BUT THE BETTER IDEA WOULD BE TO
USE THE SINGLE IRB BUT FIGURE
OUT A WAY IN WHICH THE SINGLE
IRB COULD TAKE ACCOUNT OF --
SUFFICIENT ACCOUNT OF THE LOCAL
CONTEXT IN MAKING ITS
DETERMINATIONS AND
RECOMMENDATIONS ABOUT THE STUDY.
>> ANY COMMENTS ON THAT PORTION?
IN THE LAST PARAGRAPH AT LINE
81, ONE OF THE THINGS THAT WE
FLAGGED IN THE DRAFT GUIDANCE IS
THE IDEA THAT -- OR THE
SUGGESTION THE IRB MEMBERSHIP
ITSELF AND DIVERSITY OF THAT
MEMBERSHIP WOULD BE A MECHANISM
FOR SOLVING LOCAL -- IS A
MECHANISM FOR SOLVING LOCAL
CONTEXT ISSUES, AND, YOU KNOW,
AS WE KNOW A SINGLE IRB MAY BE
DIVERSE IN ITS REPRESENTATION
BUT FOLLOWING ON THE SCENARIO
ABOVE, IT'S REALLY UNLIKELY THAT
ANY SINGLE IRB COULD -- WOULD BE
EXPECTED TO HAVE
REPRESENTATIVENESS WITHIN ITS
MEMBERSHIP TO COVER ALL OF THOSE
ISSUES, TO HAVE THEM.
SOME MIGHT SAY CERTAIN LOCAL
IRBs DON'T HAVE ONE OF
EVERYBODY ON THERE.
SO, IT'S -- OUR CONCERN IS THAT
THAT RELIANCE ON DIVERSITY OF
MEMBERSHIP TO RESOLVE CONTEXT
ISSUES IS PROBABLY SOMEWHAT
MISPLACED.
IT'S CERTAINLY A FACTOR BUT IT'S
NOT-- IT IS NOT A MECHANISM THAT
WILL BE THE SOLE WAY OF
IDENTIFYING AND MANAGING LOCAL
CONTEXT ISSUES.
>> I CAN GIVE ANOTHER EXAMPLE OF
THAT WHICH MIGHT BE AN
INTERESTING EXAMPLE.
THAT IS -- THIS ACTUALLY
OCCURRED.
KEVIN, YOU MAY HAVE BEEN
INVOLVED.
I FORGET.
A STUDY FUNDED BY ONE OF THE
INSTITUTES AT NIH OF SUBSTANCE
ABUSE INTERVENTIONS IN MEN WHO
HAVE SEX WITH MEN AROUND THE
WORLD.
SO THERE WERE FOUR OR FIVE
DIFFERENT SITES, ONE IN
THAILAND, TAIWAN, ONE IN PERHAPS
NIGERIA.
THE QUESTION THAT EMERGED IN THE
STUDY WAS WHAT ARE THE LOCAL
LAWS PERTAINING TO MEN WHO HAVE
SEX WITH MEN, THE ACTIVITY OF
MEN HAVING SEX WITH MEN, WHAT
ARE THE LAWS IN REGARD TO
SUBSTANCE ABUSE AND POSSESSION
OF NARCOTICS IN THESE DIFFERENT
COUNTRIES, AND ALL WOULD NEED TO
BE TAKEN INTO ACCOUNT BY THE
IRB, THIS IS INTERNATIONAL, BUT
IT'S A COMPARABLE SITUATION.
IF IT WERE A SINGLE IRB IT WOULD
HAVE TO TAKE INTO ACCOUNT ALL
THESE DIFFERENT SITUATIONS TO
MAKE SURE SUBJECTS WERE
APPROPRIATELY PROTECTED, PRIVACY
PROTECTIONS WERE' APPROPRIATE
AND ADEQUATE, THERE WAS
AGREEMENT WITH LOCAL LAW
ENFORCEMENT AUTHORITIES NOT TO
USE STUDY RECORDS TO PROSECUTE
ANYBODY CRIMINALLY, FOR EITHER
SEXUAL ACTIVITY OR FOR THE USE
OR POSSESSION OF CONTROLLED
SUBSTANCES UNDER THE LOCAL
JURISDICTION.
AND IN THIS CASE, ALTHOUGH IT
WAS INTERNATIONAL CONTEXT, IT
WAS AN AMERICAN INSTITUTION THAT
WAS THE PRIMARY -- THAT WAS THE
PRIME AWARDEE, SO THAT IRB IN
APPROVING THE STUDY HAVE TO TAKE
ACCOUNT OF LOCAL CONTEXTS EVEN
THOSE THERE WERE LOCAL IRBs
INVOLVED.
JUST ANOTHER EXAMPLE OF THE FACT
THAT THERE'S NO WAY THAT
EITHER -- THAT AN IRB WOULD HAVE
SUFFICIENT EXPERTISE WITHIN THE
MEMBERSHIP EVEN IF IT HAD A
DIVERSE MEMBERSHIP TO BE ABLE TO
UNDERSTAND ALL OF THESE FACTORS.
>> WALTER?
>> SO -- THANK YOU, MARK AND
DAVID.
TO THAT POINT, I THINK THE
ASSUMPTION THAT HAVING DIVERSITY
WITHIN THE IRB IS GOING TO BE
SUFFICIENT, YOU MADE THE CASE
THAT'S NOT GOING TO BE
SUFFICIENT.
WOULD IT BE CONSIDERED TO BE
OVERLY PRESCRIPTIVE TO PROVIDE A
POINTS TO CONSIDER FOR
DETERMINING WHETHER OR NOT A
CENTRAL -- YOU KNOW, A SINGLE
IRB WOULD BE APPROPRIATE OR NOT?
>> YEAH, I THINK SO, WALTER.
IN FACT, YOU GET TO THE
EXCEPTION CRITERIA ON LINE 180,
THAT'S WHAT WE'RE TRYING TO
ACCOMMODATE.
THERE ARE TWO SOLUTIONS, ONE TO
FIGURE OUT WHETHER THERE COULD
BE EXPERTISE BROUGHT TO BEAR IN
A SINGLE IRB THAT'S SUFFICIENT
TO TAKE INTO ACCOUNT LOCAL
CONTEXT, THE OTHER OPTION IS NOT
TO HAVE A SINGLE IRB.
THEY ARE POINTS TO CONSIDER IN
REGARD TO BOTH ALTERNATIVES.
>> SKIP?
>> THE LINE WE'RE QUESTIONING IN
THE DISCUSSION IS TOUCHING ON
THE ONE QUESTION I HAD, WHICH
AROSE ON THOSE THREE EXCEPTIONS
THAT YOU PROVIDED.
WHICH WERE -- WHICH IS PROCESS.
I AGREE WITH EVERYTHING YOU'RE
SAYING, I AGREE EVERYONE SHOULD
HAVE RESPONSIBILITY BUT WHAT'S
THE PROCESS, HOW WOULD YOU MAKE
A DECISION?
I WONDER IF THE INVESTIGATOR IN
THE LEAD INSTITUTION CONSULTS
WITH THEIR IRB OR SINGLE IRB
THAT PERHAPS IT WOULD BE
APPROPRIATE FOR THAT SINGLE IRB
TO SAY, THERE'S NO WAY WE CAN
POSSIBLY HAVE THE EXPERTISE IN
THAT EXAMPLE, THE EXAMPLE YOU'RE
GIVING.
>> RIGHT.
>> IT COULD BE JUST ONE SENTENCE
THAT TALKS ABOUT, YOU KNOW, THAT
PROCESS.
I PERSONALLY WOULD BE MORE
COMFORTABLE IF IT WAS THE, YOU
KNOW, THE INITIAL DESIGNATION
THE POTENTIALLY SINGLE IRB WHO
SAID NO WAY CAN WE TOUCH ALL
THESE ISSUES RATHER THAN THE
INVESTIGATOR OR THE INSTITUTION.
SO THAT'S A POINT FOR DISCUSSION
BUT I DIDN'T SEE ANYTHING THAT
WOULD SAY, WELL, AT THE END OF
THE DAY THIS IS, YOU KNOW, WHO
IS GOING TO MAKE THIS DECISION.
>> I THINK LINDA --
(INDISCERNIBLE).
>> I WAS GOING TO TRY TO ADDRESS
YOUR COMMENT, LOOKING AT
LINES -- LET'S MAKE SURE IT'S
RIGHT, 102 TO 105 TALKING ABOUT
THE RESEARCH INSTITUTION, ANY
DECISION ABOUT CONDUCTING
ADDITIONAL LOCAL IRB REVIEW,
IT'S DIFFICULT TO HAVE A SINGLE
DESCRIBED PROCESS BECAUSE THE
DECISIONS WILL DEPEND ON CONTEXT
OF THE STUDY.
AND SO I AGREE MAYBE YOU MIGHT
WANT TO MAKE A STATEMENT THAT
STATES YOU SHOULD HAVE A DEFINED
PROCESS BECAUSE IF YOU DON'T,
THIS COULD GO SIDEWAYS VERY
QUICKLY, IF YOU DON'T HAVE THAT.
BUT I THINK THAT STARTS TO TOUCH
UPON THE FACT THAT IT'S NOT
GOING TO BE ONE-SIZE-FITS-ALL
PROCESS.
MAYBE I'M MISINTERPRETING WHAT
YOU'RE ASKING.
>> MAYBE I CAN CLARIFY.
I READ THAT SENTENCE AS TALKING
ABOUT A SITE MAKING A DECISION
ABOUT ADDITIONAL INTERNAL IRB
REVIEW AS OPPOSED TO, YOU KNOW,
THE QUESTION AS TO WHETHER OR
NOT THE RESPONSIBLE PARTY,
HAVING COME OUT OF THE FDA, I
THINK THERE IS THE RESPONSIBLE
PARTY, WHETHER IT'S THE FUNDER,
THE HOLDER OF THE FUNDS FOR THAT
INITIAL INSTITUTION, THAT THAT
INSTITUTION THERE BE A PROCESS
BY WHICH THAT INSTITUTION SAYS
WE DO NOT THINK A SINGLE IRB IS
APPROPRIATE.
YOU KNOW, AND THAT COULD BE AN
IRB WHO WOULD THEN SAY, YOU
KNOW, WE DON'T THINK A SINGLE
IRB IS APPROPRIATE HERE.
I AGREE WITH EVERY EXAMPLE
YOU'VE GIVEN.
THAT WOULD BE A DAUNTING TASK
FOR ANY IRB TO DO ON THEIR OWN.
SO THAT'S WHAT I WAS SUGGESTING.
I SEE THIS MORE AS A PROCESS BY
WHICH YOU DECIDE WHAT YOU'RE
DOING AT YOUR INSTITUTION IF
YOU'RE ASKED TO PARTICIPATE,
WHICH IS DIFFERENT.
>> YEAH, I MEAN, I AGREE.
I THINK THAT'S CORRECT.
IF WE COULD MAKE THAT CLEAR IN
THE DOCUMENT THAT WOULD BE
HELPFUL.
I DON'T THINK THESE ARE -- THESE
ARE EITHER/OR.
ACCOMMODATE BOTH.
>> NO WAY YOU'RE GOING TO GIVE
ALL THE POINTS TO CONSIDER, THAT
WOULD BE A DAUNTING TASK AS
WELL.
>> I HAD TWO COMMENTS RELATING
TO THAT PARAGRAPH THAT ENDS IN
LINE 90.
AND I'LL GO TO MY SECOND LINE
BECAUSE IT RELATES TO THIS
CONVERSATION.
AND WHAT I HAD -- I APPRECIATE
THIS DISCUSSION ABOUT PROCESS TO
KNOW HOW THEY ARE GOING TO
DECIDE, WHETHER ADDITIONAL
IRB -- LOCAL IRB INFORMATION IS
IMPORTANT FOR PROVIDING
INFORMATION ABOUT THE LOCAL
CONTEXT.
I WONDERED ABOUT THIS LAST,
BEFORE, I HADN'T BEEN THINKING
ABOUT PROCESS, JUST THINKING
ABOUT THE KIND OF PUTTING IN A
LITTLE BIT OF A MORE NORMATIVE
STATEMENT IN THIS LINE BEGINNING
89.
NONETHELESS SACHRP AGREES WITH
ADVISING THAT THE INSTITUTION
CAN PROVIDE THE SINGLE IRB
ADDITIONAL INFORMATION REGARDING
LOCAL CONTEXT, THAT SEEMS SO
NEUTRAL AFTER -- IT'S ALSO
AWKWARD ADVISING THE LINE -- I
COULDN'T FIGURE OUT WHAT IT WAS
SAYING, WONDERED IF IT MIGHT
SAY, YOU KNOW, SOMETHING LIKE
THE SACHRP AGREES THAT THE
RELYING INSTITUTION CAN PROVIDE
AND SHOULD PROVIDE, YOU KNOW,
AND THAT NEEDS TO BE FURTHER
DEFINED, SHOULD PROVIDE IN
CERTAIN CONTEXT OR SOMETHING.
AND THEN MAYBE IF THERE NEEDS TO
BE ANOTHER SENTENCE OR SOMETHING
ABOUT PROCESS IT COULD GO RIGHT
AFTER THAT.
I HAD A SLIGHT CHANGE.
I DON'T KNOW IF WE'RE DOWN --
IT'S NOT A CORRECTION.
IT'S A SUBSTANTIVE.
LINE 86 TALKING ABOUT THE
SCENARIO ABOUT TRANSGENDER
TEENAGERS I.E. SINGLE IRB IS
REVIEWING A MULTI-SITE STUDY ON
TRANSGENDERED TEENAGERS AND
MULTIPLE COMMUNITIES WITH
SIGNIFICANT VARIATIONS IN
CULTURAL VALUES AMONG THOSE
COMMUNITIES.
I HAD AN OBJECTION TO CALLING IT
CULTURAL VALUES.
AND SO I WANTED TO SUGGEST THAT
WE CHANGE THAT BACK TO ACTUALLY
WHAT HAD BEEN SAID IN THE
SCENARIO, AND SAY THE
SIGNIFICANT VARIATIONS IN
ACCEPTANCE AND SUPPORT SERVICES.
SO WE'RE NOT CALLING -- WE'RE
NOT SHORTHANDING THAT
DESCRIPTION INTO CULTURAL
VALUES.
>> THAT'S FINE.
>> OKAY.
>> I ECHO THAT LAST POINT.
>> THANK YOU.
JYOTI?
>> SO, IF THE LOCAL IRB DOES GET
IN TOUCH WITH THE SINGLE IRB AND
SAYS HERE IS THE ISSUES, THE
SINGLE IRB SAYS YES, WE CAN
PROVIDE OR WE HAVE EXPERTISE, WE
DON'T KNOW WE HAVE EXPERTISE,
CAN YOU HELP?
WHAT DO WE SEE, IS THAT A
PERSON, AN INDIVIDUAL FROM THE
LOCAL IRB WOULD SERVE AS
CONSULTANT?
AM I GOING INTO THE WEEDS HERE
MAYBE?
I'M TRYING TO THINK WHAT WOULD
THAT LOOK LIKE.
>> I THINK IT COULD WORK IN A
NUMBER OF WAYS.
ONE SIMPLE ONE WOULD BE IN
PUTTING TOGETHER A PROCESS FOR
ACTING AS A SINGLE IRB THAT PART
OF THE INFORMATION SOLICITED
FROM THE RELYING SITES HAS
QUESTIONS ABOUT ARE THERE
CONTEXTUAL ISSUES RELEVANT TO
THE REVIEWING ISSUE AND THEY
SHOULD BE AWARE OF AND WHETHER
THAT HAS A TRIGGER WHERE IT
MIGHT ACTUALLY INVOLVE AN
IN-PERSON CONSULTATION BY THE
LOCAL P.I. OR REPRESENTATIVE OF
THE LOCAL IRB, IT WOULD DEPEND.
I COULD IMAGINE MECHANISMS LIKE
THAT.
CERTAINLY AT A MINIMUM HAVING
QUESTIONS THAT ASK ABOUT ANY
SITE-SPECIFIC CONCERNS THAT ARE
RELEVANT TO THE IRB IS -- THAT'S
AN EASY STARTING POINT.
YOU KNOW, HOW IT MIGHT ESCALATE
COULD TAKE A FEW DIFFERENT
PATHWAYS.
LINDA?
>> I WAS GOING TO SAY A NUMBER
OF INSTITUTIONS, I CAN'T SAY FOR
ALL, THERE'S A GATE KEEPER
PROCESS.
HRPP, THE GATE KEEPER.
WHEN INVOLVING A SINGLE IRB
THAT'S EXTERNAL TO THE
INSTITUTION, WE TYPICALLY DON'T
INVOLVE AN IRB STAFF AND
MEMBERS.
WE HAVE DEDICATED PEOPLE THAT
WORK WITH THAT EXTERNAL IRB OR
LOCAL IRB.
AND ASKING A SERIES OF
QUESTIONS, IF THERE'S
CONSULTATION IT'S NO DIFFERENT
THAN IF YOU NEED EXPERTISE WOULD
GET THE EXPERTISE, SIMILAR TO
INTERNATIONAL CONTEXT IF I'M
COMMUNICATING WITH INTERNATIONAL
SITES WE MAY HAVE TO GET
CONTEXTUAL INFORMATION TO
CONDUCT THE REVIEW.
TYPICALLY THAT'S HOW IT'S DONE.
YOU SHOULD HAVE A GATE KEEPER
PROCESS.
SOME INSTITUTIONS MAY HAVE THEIR
STRUCTURES SUCH THAT PEOPLE WEAR
MULTIPLE HATS, SO KEEPING
THOSE -- UNDERSTANDING HRPP
FUNCTION VERSUS IRB FUNCTION IS
IMPORTANT.
AT A LARGE INSTITUTION WHERE I
COME FROM WE DIFFERENTIATE THAT.
THAT'S HOW IT WORKS.
SO THERE IS A VERY ROBUST
PROCESS, SIMILAR TO HOW EXTERNAL
IRBs AND COMMERCIAL IRBs
OPERATE, MODEL THAT.
A LOT OF PEOPLE MODEL THAT.
>> SKIP?
>> BASED ON WHAT YOU JUST SAID,
LINDA, MODIFY MY ORIGINAL
COMMENTS.
IT WOULD BE REASONABLE THAT THE
RESPONSIBLE HRPP AND/OR IRB, IT
WOULDN'T BOTHER ME, FOR EXAMPLE,
IF YALE WAS THE GRANTEE AND YOU
MADE A DECISION IN AN HRPP
PROCESS TO SAY WE'LL NOT RELY ON
THE SINGLE IRB BECAUSE OF THIS,
THAT, THE OTHER REASON.
I DON'T THINK IT HAS TO BE THE
IRB PER SE.
>> WITHIN AN INSTITUTION, THE
WAY IT WORKS --
>> I'M SORRY.
THE LIGHT AROUND THE TOP OF YOUR
MIC, I DON'T THINK YOUR MIC IS
WORKING AND I'M GETTING
COMPLAINTS ON THE PUBLIC FEED
IT'S TOO SOFT.
DO YOU WANT TO SIT HERE?
>> YEAH.
(INDISCERNIBLE).
>> I WON'T BE ABLE TO PUT THIS
IN FRONT OF ME.
>> HERE.
>> THE WAY THIS ACTUALLY WORKS,
THERE ARE A NUMBER OF TOLL GATES
AT INSTITUTIONS, IT'S THE
INVESTIGATOR WHO HAS TO WRITE
THE GRANT AND THE INVESTIGATOR
IS GOING TO THINK ABOUT THESE
THINGS WHEN HE OR SHE WRITES THE
GRANT TO PUT IN THERE FOR
EXAMPLE THEY DON'T WANT TO USE A
SINGLE IRB AND NEED TO PUT IN
REASONS WHY NOT, THAT WOULD
PRESUMABLY GO IN THE PROPOSAL TO
THE FUNDING AGENCY FOR IT TO SEE
THAT THAT WAS WHAT WAS PROPOSED
OR NOT PROPOSED.
AND THAT'S ONE PIECE OF IT.
THEN THE SUB-AWARDEE P.I.s, IF
THE GRANT IS APPROVED, THEY ARE
GOING TO HAVE TO -- IF THERE'S A
SINGLE IRB, WHATEVER IS SAID IN
THE GRANT APPLICATION AND
APPROVED BY FUNDING AGENCY,
SPECIAL AWARD TERMS AND
CONDITIONS, THEY ARE GOING TO
NEED TO MAKE SURE THAT THEY
AGREE AS AN ETHICAL MATTER AND
MORAL MATTER, BASED ON THEIR
PERCEPTION OF WHETHER LOCAL
CONTEXT CAN BE TAKEN
SUFFICIENTLY INTO ACCOUNT.
SO THERE'S THE INVESTIGATOR
SIDE.
THEN THERE'S THE HRPP SIDE OF
ALL THIS BECAUSE EVEN IF THE
INVESTIGATOR THINKS ONE THING,
THE HRPP AND/OR IRB IF THERE IS
NO HRPP AT THE INSTITUTION, THEY
HAVE TO AGREE.
THERE'S GOING TO BE A
CONSULTATION PROCESS BETWEEN THE
INVESTIGATOR AT THE CENTRAL SITE
AND THE INVESTIGATORS AND THEIR
HRPPs, IRBs AT THE LOCAL
SITES.
AND THIS IS REALLY ANSWERING
YOUR QUESTION, SKIP, AND
LEVERING WHAT LINDA SAID, A
CONVERSATION ABOUT THIS STUFF.
IT REALLY STARTS WITH THE
CONVERSATION THAT THE
INVESTIGATOR HAS WITH HERSELF
ABOUT WHAT SHOULD BE THE
PROCESS, RECOMMENDED PROCESS OF
ETHICAL REVIEW.
SO I THINK IT'S POSSIBLE TO PUT
THAT, ENCAPSULATE THAT PROCESS
IN SENTENCES BUT IT'S BY
DEFINITION A SOMEWHAT MESSY
PROCESS.
>> OFTERREN TIMES HRPP IS
WORKING WITH THE INVESTIGATOR
WRITING THE GRANT, WRITING
LETTERS OF SUPPORT AND SOMETIMES
WE'LL TRY TO HELP CRAFT
ARGUMENTS AS TO WERE SOMETHING
SHOULDN'T BE SUCH AS A SINGLE
IRB FOR WHATEVER REASON OTHER
EXPLAIN TO THE INVESTIGATOR
LIKELY NOT TO WIN THAT ARGUMENT,
THIS IS WHAT YOU NEED TO DO,
HELP WITH BUDGETING AND ALL
KINDS OF THINGS.
DIFFERENT INSTITUTIONS HANDLE IT
DIFFERENTLY, BUT THAT'S WHAT MY
EXPERIENCE HAS BEEN.
>> AND JUST A FINAL POINT,
WHATEVER IS SAID IN THIS
DOCUMENT, JUST REMEMBER WHAT
WE'RE TRYING TO COMMENT ON IS
DRAFT GUIDANCE OHRP ISSUED.
TO YOUR POINT, SKIP, OHRP
GUIDANCE DOESN'T TALK ABOUT THE
PROCESS AT ALL.
SOUNDS LIKE WHAT WE NEED TO SAY
IS THAT WE DO NEED TO SAY THERE
NEEDS TO BE A PROCESS DEFINED,
AT LEAST IN OUTLINE FORM, IN THE
ULTIMATE GUIDANCE DOCUMENT.
>> THIS FLOWS INTO THE NEXT
ISSUE, THIS LOCAL SITE, REVIEW
AND APPROVAL.
AND ONE OF THE THINGS THAT STOOD
OUT TO THE SUBCOMMITTEE WAS THAT
IN THIS SECTION OF THE DRAFT
GUIDANCE THERE WAS A LOT OF
DISCUSSION ABOUT THE ROLE OF THE
LOCAL IRB AND NOT REALLY THE
LOCAL HRPP.
I THINK COMMENTS PARTICULAR LIP
-- PARTICULARLY FROM LINDA
TALKED ABOUT WHY THAT'S AN
IMPORTANT DIFFERENCE.
WE ADVOCATE GUIDANCE SHOULD BE
CLEAR ABOUT RELYING
INSTITUTION'S HRPP BEING
INVOLVED AT APPROPRIATE LEVEL IN
THE PROCESS, AND THEN ONE OF THE
THINGS THAT THE GUIDANCE
DISCUSSED THAT IS POTENTIALLY
PROBLEMATIC IS SECONDARY REVIEW
OR LOCAL REVIEW IN ADDITION TO
SINGLE IRB REVIEW WHILE WE
BELIEVE IT'S APPROPRIATE FOR A
LOCAL IRB OR LOCAL HRPP BEING
ABLE TO ADVISE THE SINGLE IRB ON
LET'S SAY LOCAL CONTEXT ISSUES,
THE IDEA THAT THEY WOULD CONDUCT
THEIR OWN IRB REVIEW AND HAVE A
STUDY THAT'S BOTH THE IRB OF
RECORD IS A SINGLE IRB BUT
THERE'S A LOCAL IRB IN PLACE
THAT'S REVIEWED AND APPROVED IT
WOULD BE CONFUSIONING AND
POTENTIALLY THE CONFLICT AND
CERTAINLY MAKE IT LESS CLEAR
WHAT THE SINGLE IRB IS -- HAS
ACTUAL OVERSIGHT OR DOES NOT
HAVE ACTUAL OVERSIGHT OF.
AND SO IN THE LONGER -- OR
SHORTER PARAGRAPH LINE 106 WE
THINK THE GUIDANCE SHOULD BE
MODIFIED TO ADVISE THAT THAT
SHOULD REALLY BE AN EXCEPTION AN
THE SINGLE IRB SHOULD BE THE
ONLY IRB THAT'S THE IRB OF
RECORD REVIEWING THAT STUDY.
AND THAT SUGGESTING OTHERWISE IN
GUIDANCE IS INCONSISTENT WITH
THE SINGLE IRB REGULATION AND
WHAT IT'S TRYING TO ACHIEVE.
LAST DISCUSSION MAY HAVE COVERED
A LOT OF WHAT'S ON THE TWO
PARAGRAPHS THAT ARE TAKING UP
THE PAGE RIGHT NOW.
AND WE'VE GOT SOME GOOD
FEEDBACK.
BUT IF THERE'S ADDITIONAL
FEEDBACK ON PARAGRAPHS AT LINES
92 AND 106 --
>> THIS IS CONSUELO.
I HAD MY HAND UP.
IS THIS A GOOD TIME?
>> YES.
>> I DO HAVE A LITTLE BIT OF
CONCERN ABOUT HOW POTENTIAL
CONFLICTS WOULD BE RESOLVED IF A
LOCAL SITE HAS CONCERNS AND THEY
ARE NOT ADDRESSED BY THE SINGLE
IRB.
DO WE THINK THAT THE LANGUAGE
HERE IS CLEAR ON WHAT WOULD
HAPPEN OR WHAT WOULD NEED TO
HAPPEN?
>> I DON'T KNOW IF THE LANGUAGE
ITSELF IS CLEAR.
I THINK, YOU KNOW, IF IT'S NOT
CLEAR THERE IS NO REASON THAT
THE GUIDANCE CANNOT REMIND THAT
INSTITUTIONS ALWAYS HAVE THE
AUTHORITY TO DISAPPROVE
SOMETHING THAT THE IRB HAS
APPROVED.
SO AN INSTITUTION, WHETHER AT
THE HRPP LEVEL OR ADMINISTRATIVE
LEVEL, WHATEVER, CAN ALWAYS SAY,
WELL, YOU KNOW, WE DON'T BELIEVE
THIS RESEARCH IS APPROPRIATE,
THE WAY IT'S DESIGNED AND BEING
IMPLEMENTED IS APPROPRIATE SO
WE'RE NOT GOING TO PARTICIPATE.
THAT'S ALREADY A MECHANISM IN
PLACE EXERCISED FROM TIME TO
TIME.
NOT JUST IN THE CONTEXT OF
SINGLE IRB BUT FOR AN
INVESTIGATOR THAT WANTS TO DO
SOME SORT OF STUDY THAT
INSTITUTION DOES NOT SUPPORT.
SO --
>> WELL, I THINK WHERE I'M GOING
WITH THIS IS REALLY MORE ALONG
THE LINES OF IF THE ONLY OPTION
IS TO NOT PARTICIPATE, IS NOT TO
PARTICIPATE, THEN THAT'S REALLY
REINFORCING THE SYSTEMS OF
EXCLUSION SUCH THAT, YOU KNOW,
MINORATIZED MARGINALIZED
POPULATIONS WHO MIGHT HAVE
OBJECTIONS TO A SPECIFIC
APPROACH OR STRATEGY, WHO REALLY
NEED TO, WANT TO, SHOULD BE
PARTICIPATING IN THE RESEARCH,
IF THOSE ISSUES CAN'T BE
ADDRESSED THEN IF OUR ONLY
OPTION IS TO SAY, WELL, IF YOU
DON'T LIKE WHAT THE SINGLE IRB
SAYS, THEN YOU DON'T HAVE TO
PARTICIPATE.
>> YEAH, NO, I AGREE AND THAT'S
A FAIR POINT.
I THINK THAT OUTCOME WHERE A
LOCAL SITE ELECTED TO NOT
PARTICIPATE IN THE RESEARCH
WOULD BE REALLY THE EXCEPTION.
ONE WOULD HOPE THERE WOULD
ACTUALLY BE A DIALOGUE BETWEEN
THAT SITE AND THE SINGLE IRB,
MAYBE INCLUDING THE SPONSOR OR
FUNDER IF THEY THOUGHT SOMETHING
WAS FLAWED APPROVED BY THE
SINGLE IRB THAT COULD BE
ADDRESSED OR OTHERWISE MANAGED
BEFORE GETTING THAT EXTREME
FINAL POINT WHERE THERE'S A
BREAKAWAY.
AND, AGAIN, IF THE GUIDANCE CAN
BE IMPROVED BY COMMENTING ON
THAT, WE CAN PUT THAT INTO OUR
DOCUMENT.
MARK?
>> DAVID, WE ALSO CAN SAY IN
THIS DOCUMENT THAT NOT ONLY
SHOULD BE THERE IN CASE BE AN
ACTIVE COLLOQUY BETWEEN THE
LOCAL INSTITUTION AND THE SINGLE
IRB AND THE INSTITUTION THAT
SPONSORS IT, ALSO A COLLOQUY
AMONG THE LOCAL INVESTIGATOR AND
THE PRINCIPAL INVESTIGATOR, BUT
ALSO, YOU KNOW, THERE'S NO
REASON WHY IN THIS CASE THERE
REALLY IS THAT DEEP A
DISAGREEMENT THAT THE LOCAL
INSTITUTION COULDN'T SAY, YOU
KNOW, WE REALLY THINK THERE
SHOULD BE A PETITION FOR AN
EXCEPTION.
SO THAT WE CAN APPROVE IT OR NOT
ON LOCAL BASIS.
NOT SAYING IT HAS TO BE THAT
WAY, BUT LOCAL INSTITUTION OUGHT
TO BE ABLE TO ASK FOR THAT,
WHETHER THE LEAD P.I., PRIME
AWARDEE WANTS TO AGREE OR NOT IS
GOING TO BE UP TO THEM AND ALSO
THE FUNDER'S GOT TO AGREE WITH
IT TOO SO ... BUT IT IS AN
OPTION.
IT'S A PROCEDURAL OPTION.
>> YEAH, GO AHEAD.
>> IN THAT SITUATION, WOULDN'T
IT ALSO BE APPROPRIATE IF YOU
CAN'T RESOLVE A SITUATION WHERE
YOU MAKE THAT ARGUMENT AS TO WHY
THE SINGLE IRB IS NOT
APPROPRIATE, SO IN ADDITION TO
TRYING TO DO WHAT YOU SAY THAT
WOULD BE ONE ARGUMENT FOR WHY
YOU STILL WANT TO DO THE STUDY
BUT WE WANT TO DO IT A DIFFERENT
WAY, MODIFIED SUCH THAT IT COULD
BE DONE LOCALLY OR YOU COULD DO
A DUAL REVIEW BUT THAT COULD BE
COMPLICATED.
>> THE EXCEPTION FROM THE SINGLE
IRB.
>> YEAH.
>> YOU KNOW, THE BOTTOM LINE
POINT, THAT'S THE KIND OF DETAIL
THAT'S NEEDED IN THIS GUIDANCE,
WE THINK, THAT'S NOT IN THE --
JERRY, THE GUIDANCE IS AT A
HIGHER LEVEL THAN WHAT WE'RE
TALKING ABOUT.
THESE ARE THE KIND OF QUESTIONS
THAT ACTUALLY COME UP IN THE
LIFE OF AN IRB, TRYING TO
IMPLEMENT THE SINGLE IRB POLICY.
SO, I MEAN, WHAT THE
SUBCOMMITTEES ARE TRYING TO SAY,
IT'S UP TO YOU AGREE OR NOT,
MORE DETAIL IS NEEDED FOR THE
REGULAR LA OF -- REGULATED
COMMUNITY TO PUZZLE THEIR WAY
THROUGH THIS. .
>> AND THE REMAINDER OF THIS
SECTION STARTING AT LINE 113
SIMPLY REFLECTS THE DISCUSSIONS
WE'VE BEEN HAVING, THAT, YOU
KNOW, THE ROLE OF THE RELYING
INSTITUTIONS HRPP HAS TO BE
CLEARLY DELINEATED IN THE
GUIDANCE AND -- YEAH, THIS
SECTION JUST REFLECTS WHAT
W E'VE BEEN TALKING ABOUT.
I'M GOING TO MOVE ON TO THE
SECTION OF COMPLIANCE
INVESTIGATIONS AT LOCAL SITES, A
FAIRLY SHORT BUT IMPORTANT ONE.
OBVIOUSLY, NOBODY ENJOYS
COMPLIANCE ISSUES BUT MULTI-SITE
RESEARCH CAN GET -- OR SINGLE
IRB RESEARCH, IT CAN BECOME
TRICKY BECAUSE THE
NON-COMPLIANCE OR THE POTENTIAL
NON-COMPLIANCE ISSUE AT A SITE
MAY NOT BE THE SITE WHERE THE
SINGLE IRB IS LOCATED.
AND ORGANIZATIONS, INSTITUTIONS,
WHAT HAVE YOU, TEND TO GET
PRICKLY WHEN IT COMES TO
COMPLIANCE THINGS.
WE WANT TO HAVE SOME INVOLVEMENT
IN OVERSIGHT OF THOSE THINGS SO
THE QUESTION THAT SORT OF WE TRY
TO ADDRESS IN THIS SECTION IS
SO, YOU KNOW, WHERE DOES THAT
LEAVE THE SINGLE IRB?
WHAT IS THE ROLE IN COMPLIANCE
OVERSIGHT FOR MULTI-SITE STUDIES
INCLUDING THE SITES WHERE THERE
ARE NOT QUOTE/UNQUOTE LOCAL IRB
BUT SERVING AS REVIEWING IRB FOR
ANOTHER SITE, IN GENERAL, YOU
KNOW, WE THINK MUCH OF THIS
SHOULD BE DEALT WITH THROUGH
RELIANCE AGREEMENTS, AND THAT IN
FACT IS WHAT OFTEN HAPPENS IN
PRACTICE NOW, BUT AGAIN FOR
IRBs THAT ARE GOING INTO THAT
ROLE OF BEING A SINGLE IRB OR
INSTITUTIONS NOW USING OR CEDING
REVIEW TO A SINGLE IRB ON A MORE
FREQUENT BASIS WE THINK THE
GUIDANCE SHOULD BE REALLY CLEAR
IN RECOMMENDING THE OUTLINING OF
THOSE TERMS IN THE RELIANCE
PROCESS, BEFORE IT GETS TO IRB
REVIEW PUTTING IN PLACE, YOU
KNOW, THE OLD IRB AUTHORIZATION
AGREEMENTS, SORT OF A MODEL OF
WE'LL RELY ON THE IRB FOR THIS.
BUT IT'S IMPORTANT TO CALL THIS
OUT BECAUSE WHEN THERE ARE
COMPLIANCE ISSUES FROM A
REGULATORY STANDPOINT THE
REVIEWING IRB HAS OBLIGATIONS,
AND WE DON'T -- YOU KNOW, THEY
DON'T WANT TO BE NUT A POSITION
WHERE THEIR ABILITY TO CARRY OUT
REGULATORY POSITIONS FOR MAKING
DETERMINATIONS OF NON-COMPLIANCE
ARE HAMPERED AND DERAILED
BECAUSE OF POOR COOPERATION
BETWEEN RELYING SITE AND
REVIEWING SITE.
IN THIS SECTION WE DISCUSS THAT
AND REALLY, AGAIN, FEEL THE
ANSWER IS JUST THE GUIDANCE
SHOULD BE CLEAR THAT THESE
ISSUES REALLY NEED TO BE
ADDRESSED ON THE FRONT END AND
NOT WAIT FOR COMPLIANCE ISSUE TO
ARISE TO DEAL WITH THEM.
ANY COMMENTS OR QUESTIONS ON
THIS SECTION?
YES?
>> I JUST HAD A -- ON THE
SENTENCE STARTING ON 19,
SLIGHTLY SUBSTANTIVE BUT MOSTLY
JUST WORDING.
LATER OR --
>> GO AHEAD.
>> I THINK YOU HAVE A MISPLACED
MODIFIER IF VIOLATIONS ARE
FOUND, STRIKE THROUGH THAT AND
SAY WE'LL INCLUDE THAT LATER,
THE DRAFT GUIDANCE SHOULD ALSO
IDENTIFY THE CIRCUMSTANCES UNDER
WHICH THE SINGLE IRB SHOULD
PROVIDE ADVANCE NOTICE ABOUT
VIOLATIONS FOUND AT THE SITE.
AND THEN THE REST OF THE
SENTENCE WOULD CONTINUE.
SO IT'S A LITTLE STRONGER.
>> SORRY, MY KEYBOARD WAS ACTING
FUNNY.
>> SAY IT AGAIN?
>> I THINK I GOT IT, BUT PLACED
AFTER THIS INSTANCE OF HRPP?
>> STARTING WITH THAT SENTENCE,
IF VIOLATIONS ARE FOUND.
>> RIGHT.
>> THAT'S GONE.
THEN IT SAYS THE DRAFT GUIDANCE
SHOULD ALSO IDENTIFY THE
CIRCUMSTANCES UNDER WHICH THE
SINGLE IRB SHOULD PROVIDE
ADVANCE NOTICE TO RELYING HRPP
ABOUT VIOLATIONS FOUND AT THE
SITE.
AND THEN THE REST OF THE
SENTENCE WOULD BE THE SAME.
INSTEAD OF JUST -- BEFORE IF
VIOLATIONS ARE FOUND, THAT WAS
MODIFYING THE DRAFT GUIDANCE,
MAKES SENSE GRAMMAR-WISE OR
WHATEVER, BUT THE
APPROPRIATENESS OF ADVANCE
NOTICE, IT COULD GO FURTHER IN
IDENTIFYING THE CIRCUMSTANCES
UNDER WHICH THE SINGLE IRB
SHOULD PROVIDE ADVANCE NOTICE.
I GUESS ASKING FOR THE GUIDANCE
TO PROVIDE A LITTLE BIT MORE,
SORT OF SAYING IT WOULD BE
APPROPRIATE, IDENTIFY
APPROPRIATE, THAT SEEMED VAGUE.
I JUST SHARPENED IT A LITTLE BIT
I HOPE.
TRIED TO.
>> DAVID, WHAT WE'RE TALKING
ABOUT IS ADVANCE NOTICE BEFORE.
>> THAT'S HOW I READ IT.
>> THIS HAS BEEN THROUGH A
NUMBER OF HANDS.
>> THIS KEYBOARD KEEPS CUTTING
OUT ON ME.
>> I'M WRITING IT DOWN.
>> OKAY.
OTHER COMMENTS ON THAT SECTION?
THANKS, LOIS.
OKAY.
ANOTHER ISSUE THAT'S RELATIVELY
MINOR BUT STILL IMPORTANT IS
THIS NOTION OF UNFUNDED
COLLABORATORS.
IN PART BECAUSE WE'RE TALKING
ABOUT A COMMON RULE REQUIREMENT
THAT, YOU KNOW, RESEARCH THAT IS
LIKELY SINGLE IRB BUT THERE MAY
BE SCENARIOS SOME SITES ARE
FEDERALLY SUPPORTED AND OTHERS
ARE NOT.
AND, YOU KNOW, WE JUST THINK THE
GUIDANCE SHOULD CLARIFY WHAT
SHOULD BE THE -- WHAT'S
APPROPRIATE WAY TO MANAGE WHEN
THE SINGLE IRB IS -- A STUDY
THAT OTHERWISE QUALIFIES FOR
SINGLE IRB REVIEW BUT I DON'T
KNOW HOW COMMON THE SCENARIO IS
BUT SCENARIO THAT COULD TAKE
PLACE AND COULD LEAD TO SOME
CONFUSION BECAUSE OTHER
REGULATIONS ADDRESS SINGLE IRB.
>> I THINK THIS IS A REAL
SITUATION.
IT'S AKIN TO THE DEFINITION OF
WHAT IS FEDERAL SUPPORT FOR
THESE PURPOSES.
IN OTHER WORDS IF YOU HAVE ONE
UNFUNNED OR TWO OR THREE
UNFUNDED SITES FUNDED BY THE
GATES FOUNDATION TO DO SOMETHING
BUT NOT FUNDED BY NIH, THE LEAD
SITE IS FUNDED BY NIH AND TWO
OTHER SITES, HOW DOES THE SINGLE
IRB REQUIREMENT APPLY?
TO THE ENTIRE STUDY?
RECEIPT OF FEDERAL MONEY BY ONE
INSTITUTION BASICALLY AFFECT THE
ENTIRE STUDY WITH THE SINGLE IRB
REQUIREMENT OR NOT?
I THINK -- YOU KNOW, I DON'T
HAVE A STRONG -- A NORMATIVE
FEELING BUT IT'S A REAL
SITUATION THAT NEEDS TO BE
ANTICIPATED.
>> SKIP?
>> SHOULDN'T WE BASICALLY SAY
WHAT WE THINK WOULD BE THE BEST
ANSWER TO THAT QUESTION?
>> I THINK WE SHOULD.
I WAS WAITING FOR YOU TO TELL ME
WHAT THAT WAS.
>> WELL, TEN YEARS AT THE FDA
I'M A FAN OF HOLDING SOMEONE
RESPONSIBLE.
I'M A FAN OF THAT BEING THE LEAD
INSTITUTION.
IT'S POSSIBLE THE LEAD
INSTITUTION COULD BE A GATES
FOUNDATION FUNDED AND NOT THE
NIH BUT SOMEWHERE THERE'S A LEAD
INSTITUTION PRESUMABLY.
>> RIGHT.
>> IT WOULD BE THAT INSTITUTION,
I THINK I WOULD HOLD
RESPONSIBILITY, INDEPENDENT OF
COMPLEXITY OF THE FUNDING.
>> IF THE LEAD INSTITUTION IS
NOT FEDERALLY FUNDED.
IF IT IS, THE SINGLE IRB
REQUIREMENT NEEDS TO BE MET.
IF NOT, EVEN IF SOME SITES ARE,
WOULD NOT NEED TO BE MET.
>> IT'S A MATTER OF POLICY, YES,
BUT I THINK AS A MATTER OF GOOD
PRACTICE I WOULD ARGUE IT WOULD
BE APPROPRIATE TO APPLY THE SAME
POLICY.
I GUESS IT WOULDN'T APPLY THEN.
I THINK WE'RE DISCUSSING WHETHER
IT'S GOOD PRACTICE AS WELL.
>> YES, I AGREE.
I AGREE.
>> RIGHT.
>> WE COULD SAY WE THINK THAT
SACHRP, IN DOMESTIC STUDIES,
BEST PRACTICE, WHEN YOU CAN, TO
USE A SINGLE IRB MODEL BUT WHEN
THE LEAD INSTITUTION IS ACTUALLY
NOT FEDERALLY FUNDED THEN IT
WOULD BE UP TO THAT INSTITUTION
IN CONSULTATION WITH THE OTHER
SITES TO DETERMINE WHETHER A
SINGLE IRB IS APPROPRIATE OR
NOT.
>> YEAH.
I DON'T KNOW IF OTHERS AGREE,
THAT WOULD BE MY APPROACH.
>> I MEAN BASICALLY IT BECOMES A
DECISION FOR THE SPONSOR, WHAT
HAPPENS IN INDUSTRY-FUNDED
STUDIES ALL THE TIME.
SPONSOR SAYS THIS IS WHAT THE
IRB IS GOING TO BE FOR THIS.
>> OKAY.
>> ONE OF THE MORE CHALLENGING
ISSUES, JUST IN GENERAL WITH
SINGLE IRB, IS COMPLIANCE WITH
LOCAL LAWS.
I MEAN, THIS IS A REAL -- THIS
IS A CHALLENGE FOR ANY IRB
THAT'S TRYING TO WORK AS A
SINGLE IRB, PARTICULARLY FOR
INSTITUTIONAL IRBs, LOCAL
IRBs FOR THE FIRST TIME IT'S
UNCHARTERED WATERS.
THEY HAVEN'T GONE DOWN THE
PATHWAYS TO FIGURE IT OUT IN A
WAY THAT IS EFFICIENT AND
COMPLIANT.
AND SO THIS IS AN AREA WHERE WE
THINK GUIDANCE REALLY SHOULD BE
SAYING MORE.
I MEAN, WITH DRAFT GUIDANCE
EMPHASIZING THE SINGLE IRB MUST
HAVE ABILITY TO ASSESS LOCAL
LAWS BUT DOESN'T TALK ABOUT
PROCESS, HOW THAT MIGHT WORK,
WHAT SHOULD BE DONE IN THAT
CASE.
YOU KNOW, A LOW-HANGING FRUIT
EXAMPLE IS STATE PRIVACY LAWS
WHICH ARE MANY AND EVOLVING.
AND OFTEN HAVE A DIRECT IMPACT
ON RESEARCH ACTIVITIES.
HERE, YOU KNOW, THE SINGLE IRB
WILL NEED A WAY TO BE ABLE TO
PROPERLY ASSESS STATE LAWS AND
ENSURE THAT FOR THE VARIOUS
SITES THAT ARE NOW UNDER ITS IRB
OVERSIGHT THAT THEY ARE
FOLLOWING THOSE LOCAL
REQUIREMENTS.
AND TO THAT END, WE SUGGEST THAT
THE DRAFT GUIDANCE SHOULD TALK
FURTHER ABOUT THE SINGLE IRB'S
RESPONSIBILITY AND SCOPE OF THAT
RESPONSIBILITY IN TERMS OF
ASSESSING THE LAWS APPLICABLE TO
THE RESEARCH THAT IT REVIEWS AND
APPROVES, AND THAT ULTIMATELY
THE SINGLE IRB SHOULD SEEK TO
REVIEW LOCAL INFORMATION.
BUT AT THE END OF THE DAY SINGLE
IRB STILL HAS THAT -- HAS SOME
LEVEL OF RESPONSIBILITY FOR
ENSURING THAT THEY DID WHAT THEY
ARE SUPPOSED TO DO WITH RESPECT
TO THAT.
AND IN SOME WAYS IT'S A LITTLE
SIMILAR TO THE LOCAL CONTEXT
QUESTION, WHAT CAN THEY DO FROM
PROS TOES FIND OUT -- PROCESS
TO FIND OUT WHAT ARE LOCAL LAWS,
WITH THE INTAKE MECHANISM
ASSESSING OTHER CONTEXT ISSUES
RELATED TO IT.
AND THEN WE END THIS SECTION BY
RECOMMENDING THAT OHRP COMPILE
STATE LAW DATABASE THAT IS
COLLECTED AND MAINTAINED.
IT'S A LOT OF WORK BUT IT'S
POSSIBLE.
AND IT'S NOT ENTIRELY WITHOUT
PRECEDENT.
THERE'S THE INTERNATIONAL
COMPENDIUM THAT COULD SERVE AS A
MODEL BUT WE HAVE RESOURCES FOR
HHS TO PROVIDE THOSE RESOURCES
SO THE WORK CAN BE DONE.
LOIS?
>> THAT WAS THE SUBSTANTIVE
THING IN THIS DOCUMENT THAT I
QUESTIONED, WHETHER THAT SHOULD
BE WHERE OHRP AND HHS PUT THEIR
RESOURCES, AND, YOU KNOW, I MEAN
I'VE DONE KIND OF -- YOU KNOW,
STATEWIDE KIND OF RESEARCH, AND
IT IS REALLY -- THAT IS JUST A
LOT OF WORK.
AND THEN TO UPDATE, AND SO, YOU
KNOW, SEEMS TO ME THAT'S THE
COST OF DOING RESEARCH, AND
SHOULD BE, YOU KNOW, SHOULDERED
BY THE INSTITUTIONS THAT ARE
PERFORMING THE RESEARCH, WHETHER
IT'S THE SINGLE IRB TAKES IT ON,
IN CONSULTATION OR, YOU KNOW,
SAYS THAT THE LOCAL HRPPs HAVE
TO PROVIDE AND TAKE -- YOU KNOW,
I WONDER IF THERE ARE NOT OTHER
THINGS THAT OHRP SHOULD BE
DOING, AND IF THERE'S TIME AND
MONEY.
>> KEVIN?
>> SORT OF A NAIVE QUESTION BUT
I WONDER HOW HAVING SUCH A
RESOURCE WOULD CHANGE THE ACTUAL
BEHAVIOR OF SINGLE IRBs AND
RESPONSIBILITIES SO, FOR
EXAMPLE, WOULD ANY SINGLE IRB
JUST ONLY RELY ON THAT AND THEN
IF THEY ARE CALLED OUT ON
MISSING SOMETHING, IT WASN'T IN
THE DATABASE, I'M GUESSING NOT.
SO TO WHAT EXTENT ARE PEOPLE
GOING TO BE DOING THAT WORK
ANYWAY, JUST ANOTHER THING THAT
OCCURRED TO ME ABOUT THE
HELPFULNESS OF THIS.
>> WALTER?
>> I WAS ACTUALLY COMING FROM
THE OPPOSITE PERSPECTIVE WHICH
WAS THINKING THAT WITH ALL THE
EFFORT BEING MADE IN INFORMATICS
NOW, IT MIGHT ACTUALLY BE EASIER
TO PULL EVOLVING LAWS INTO A
COMMON DATABASE IN A WAY THAT IS
LESS ONEROUS THAN HAS BEEN IN
THE PAST.
I AGREE, LOIS, HISTORICALLY -- I
CAN SEE THIS FROM A PERSPECTIVE
OF A LOCAL IRB THAT'S SERVING AS
A COORDINATING CENTER, THAT IT'S
VERY -- YOU KNOW, IT'S
CHALLENGING.
THEY MAY NOT HAVE THE EXPERTISE
BUT THERE ARE -- THERE MUST BE
MECHANISMS TO PULL THIS AND
MAYBE, MARK, YOU CAN SPEAK FROM
OTHER AREAS OF THE LAW, WHERE
THERE ARE ADVANCES BEING MADE
THAT MAY FACILITATE, PULLING IN
AN ONGOING MANNER NEW LAWS WHICH
WOULD AT LEAST MAKE THE
RESOURCES AVAILABLE,
INTERPRETING THEM IS ANOTHER
THING BUT PULLING THEM MAY BE --
THERE MAY BE AN EASIER SOLUTION
THAN THERE WAS FIVE YEARS AGO.
>> I THINK THERE PROBABLY IS.
ONE COULD WRITE PROGRAMS LIKE
A.I. PROGRAMS TO TROLL THE WEB
FROM STATE LEGISLATIVE
AUTHORITIES AND REGULATORY
BODIES, IT'S NOT GOING TO BE
FOOLPROOF, SO WE COULD
ELIMINATE -- THIS WAS A
PROCEDURAL RECOMMENDATION THE
SUBCOMMITTEE HAD, AND WE CAN
DELETE IT, WE CAN SAY WHAT
WALTER SAID.
OHRP DOES DO THIS ON THE
INTERNATIONAL SCENE RIGHT NOW SO
IT'S NOT UNPRECEDENTED AND IT'S
NOT FOOLPROOF BECAUSE THERE ARE
LOTS OF THINGS THAT ARE IN THESE
LOCAL, NATIONAL JURISDICTIONS
NOT PICKED UP BY THE OHRP
SERVICE IN THIS REGARD BUT A LOT
IS PICKED UP.
SO IT'S KIND OF A USEFUL
COMPENDIUM, BUT IT'S NOT
CONCLUSIVE.
>> I THINK PART OF WHY WE PUT
THIS IN HERE AT THE SUBCOMMITTEE
LEVEL AT LEAST WAS THE IDEA THAT
IF THERE'S NOW A REGULATORY
MANDATE TO DO SINGLE IRB AND
IMPLEMENT IT, THEN NOT PROVIDING
THOSE TOOLS DOESN'T SEEM FAIR IN
MANY WAYS BECAUSE IT'S NOT --
FOR A LOT OF RESEARCH NOW IT'S
NOT AN OPTION, AND THE
ORGANIZATIONS OR INSTITUTIONS
THAT MIGHT BE TAKING ON THAT
ROLE HAVEN'T DONE IT
HISTORICALLY SO HAVEN'T BUILT UP
THAT EXPERIENCE OR HAVE THAT
INFORMATION AT THEIR FINGER
TIPS.
LINDA?
>> I WAS GOING TO SAY I THINK
THAT FROM EXPERIENCE,
INTERNATIONAL CONTEXT, RELY ON
INTERNATIONAL COMPENDIUM.
YOU START WITH LOCATION, STILL
HAVE ADDICTAL OBLIGATION TO
EVALUATE.
YOU MAY HAVE TO GET ADVICE FROM
OUR LEGAL COUNSEL.
EVEN IF YOU HAVE THIS RESOURCE
YOU STILL HAVE THIS OBLIGATION
IF YOU TAKE ON THAT
RESPONSIBILITY I THINK THAT'S
THE SCARY PART FOR
ORGANIZATIONS, WHAT HAPPENS IF
YOU MAKE A MISTAKE OR
MISINTERPRET LANGUAGE.
THAT'S THE PART THAT IS A LITTLE
BIT MORE PROBLEMATIC BECAUSE
SIMPLY HAVING A RESEARCHER GIVE
YOU HERE IS WHAT THE LAW SAYS,
HOW YOU APPLY, THAT'S THE PART
IN THE WEEDS, THE PART THAT IT
WOULD BE NICE TO FIGURE OUT A
SOLUTION, IF YOU COULD WORK
TOGETHER, THE RESEARCH COMMUNITY
DID HELP IN THAT REGARD, PROVIDE
RESOURCES AND HOW YOU APPLY, IT
MAKES IT EASIER.
HAVING EVERYONE DO IT ON THEIR
OWN EVEN THOUGH YOU HAVE TO DO
SOME OF THAT IS A LOT OF EXTRA
WORK AND COST TO THE
ORGANIZATION AS WELL.
>> SO, YOU KNOW, THAT'S A GREAT
POINT.
AT THE SAME TIME I DON'T KNOW IF
THAT NEEDS TO BE THE GOVERNMENT
DOING THAT.
YOU KNOW, WITH THE LIMITED
RESOURCES.
MAYBE SOME KIND OF COLLABORATION
AMONG RESEARCH INSTITUTIONS TO
PULL THAT TOGETHER OR SO -- I
JUST HAVE CONCERN.
WHAT'S THIS COMPUTED WITH IN
TERMS OF WHAT ELSE COULD BE
DONE, IF THERE'S, YOU KNOW,
RESOURCES AND STAFFING AND OTHER
BURNING QUESTIONS.
>> I THINK THAT'S -- GO AHEAD,
LINDA.
>> I WAS GOING TO SAY THE SAME
THING.
IT'S WORTH LEADING, MY OPINION,
IN THE DOCUMENT, THEN WE CAN
ALSO SUGGEST SOME OTHER OPTIONS
TO CONSIDER.
I LIKE TO HAVE OPTIONS TO
CONSIDER SO I UNDERSTAND YOUR
POINT.
JUST SORT OF SPEAKING FROM
EXPERIENCE HOW TO USE THE
RESOURCE, IT'S BEEN VERY
BENEFICIAL BUT I AGREE COULD ADD
SUGGESTIONS FOR SOME THINGS TO
CONSIDER.
MAYBE THAT'S A HAPPY COMPROMISE.
>> I THINK IN THE INTEREST OF
THE DOCUMENT, WE SORT OF HAVE TO
FIGURE OUT WHAT YOU ALL WANT TO
SAY TODAY.
AND SO I JUST SAY THAT PLAINLY
SO WE CAN -- THIS ONE WE CAN'T
TURN AROUND UNTIL THE NEXT
SACHRP MEETING.
ALONG THE LINES OF WHAT YOU'RE
SAYING, LINDA, ONE THING WE
COULD DO, USE THIS SECTION OF
THESE COMMENTS TO MAKE SURE IT'S
KNOWN AS ISSUE AND TALK ABOUT
MULTIPLE WAYS IT COULD BE
ADDRESSED, OHRP GETTING FUNDING,
A COLLABORATION BETWEEN RESEARCH
ORGANIZATIONS TO CONTRIBUTE,
SOME COMBINATION, OHRP SOLICITS
INFORMATION FROM THE PUBLIC FROM
INSTITUTIONS TO GET THAT BUT,
YOU KNOW, WE COME UP WITH A FEW
OPTIONS THAT ARE ON THE TABLE
BUT MOST IMPORTANTLY THAT IT'S
IN THE GUIDANCE, IN THE RESPONSE
TO GUIDANCE THAT IT PROBABLY
NEEDS TO BE MORE -- ADDRESSED
MORE COMPLETELY.
DOES THAT SOUND RIGHT, MARK?
>> I THINK THAT'S RIGHT.
I THINK WE CAN SCOPE IT OUT AS
AN ISSUE THAT WOULD BE USEFUL TO
BE SOLVED, WHETHER BY OHRP OR
SOMEBODY ELSE AND POINT OUT THAT
THE USEFULNESS OF THE
INTERNATIONAL RESOURCE IS
ALREADY AVAILABLE.
MAYBE THAT'S THE WAY TO HANDLE
IT.
>> GOOD.
>> THERE WAS AN NIH-FUNDED
STUDY, WHICH I WAS INVOLVED,
CLAYTON, SUSAN WOLF, NIH FUNDED
AN ENTIRE PROJECT ON TRYING TO
UNDERSTAND THE STATE LAWS OF
GENOMIC AND GENETIC PRIVACY AND
TESTING, AND THAT DID ASSEMBLE
AN ENTIRE DATABASE OF ALL THE
STATE LAWS BUT THE PROBLEM IS
NIH DID NOT PROVIDE CONTINUED
FUNDING SO THE LAW, RESOURCE IS
USEFUL, IT WAS OUTDATED ON THE
DAY WE PUT IT ON THE WEB.
SO IT IS A CHALLENGE, UNLESS ONE
CAN COME UP WITH AN A.I.
RESOURCE TO TROLL THE WEB AND
STILL HAS TO BE CURATED.
>> MARK, TO THAT POINT,
PRIMARILY A LOCAL IRB THAT HAS
RESPONSIBILITY FOR, YOU KNOW,
MULTI-CENTER STUDY BUT IT WOULD
BE -- THIS WOULD SEEM LIKE A
SIGNIFICANT BURDEN TO THEM TO
TRY TO COLLATE RELEVANT LAWS FOR
PARTICIPATING CENTERS SO
HAVING -- THE SPIRIT OF THE
SUGGESTION WAS IN PART TO BE
ABLE TO PROVIDE A REFERENCE THAT
COULD BE USED TO ESSENTIALLY
INDICATE THAT THEY HAVE INDEED
SOUGHT ACCESS TO ALL AVAILABLE
AND CURRENT DATA AS OPPOSED TO
THE UNCERTAINTY OF LOOKING FOR
IT THEMSELVES.
>> SO THE OTHER OPTION I WAS
THINKING OF IF IT SEEMS TOO
BURDENSOME FOR OHRP IS THAT
SOMETHING THE INSTITUTION CAN
REQUEST FUNDS FOR, THE SINGLE
IRB CAN THEY ADD TO GRANT
APPLICATIONS SAYING THEY NEED
THIS TO DO MORE RESEARCH TO HELP
WITH THAT.
>> (INDISCERNIBLE).
>> YEAH, I MEAN, THAT COULD BE
AN OPTION.
I THINK YOU HAVE -- I THINK THE
THINGS THAT I WOULD FIND
PROBLEMATIC ABOUT THAT IS THEN
WOULD YOU HAVE LOTS OF PEOPLE
PUTTING IN REQUESTS FOR GRANTS
TO DO THE SAME WORK OVER AND
OVER AGAIN.
AND THERE'S THE ONGOING PROBLEM
FOR MARK'S EXAMPLE OF THE
PROJECT HE WAS INVOLVED WITH
MAINTAINING IT, YOU KNOW,
DOWNSTREAM.
AND IT'S A GRANT TO PULL IT
TOGETHER BUT DOESN'T HAVE A
GRANT TO KEEP IT UP.
THERE MIGHT BE NO INCENTIVE TO
DO SO.
HOWEVER, SINCE IT'S PART OF A
REGULATORY MANDATE, I DON'T KNOW
FANTASTIC OFF THE TABLE BUT THAT
WOULD BE MY OFF THE CUFF TO THAT
APPROACH.
>> THE EXAMPLE OF THE
INTERNATIONAL STUDY OF MEN WHO
HAVE SEX WITH MEN AND SUBSTANCE
ABUSE INTERVENTIONS I THINK
GETTING LOCAL LEGAL OPINIONS
ABOUT WHAT THE LEGALITY OF THESE
SITUATIONS MIGHT BE IF
IDENTIFIED IN RESEARCH RECORDS,
PUT ON AS DIRECT COST OF GRANT,
ALLOWABLE.
WHAT NIH WOULD SAY FOR DOMESTIC
SITUATIONS THAT WOULD BE PART OF
THE INDIRECT LEGAL COST OF
THE -- INDIRECT COST, LEGAL
SERVICES NEGOTIATED IN IDC
RATES.
I THINK IT COULD BE POSSIBLE.
>> THERE COULD BE A FUNDING
OPPORTUNITY TO DO THIS WORK AS A
WAY TO KICK START IT, NOT
SPECIFIC TO ANY ONE STUDY.
>> THAT'S TRUE.
FUNDED BY THE NIH TO TAKE CARE
OF THE PROBLEM WHICH IS THE
STATES HAVE THIS PANOPLY OF LAWS
ABOUT GENOMIC TESTING, GENOMIC
SEQUENCING AND TESTING.
AND SO NIH THOUGHT IN ORDER TO
BE ABLE TO ALLOW RESEARCHERS TO
HAVE A RESOURCE IT WOULD FUND
THIS PROJECT, AS I SAID THAT
DIDN'T CONTINUE THE FUNDING.
BUT IF THERE IS GOING TO BE A
SINGLE IRB MANDATE, THEN BOTH AT
THE FUNDER LEVEL AT NIH AND
OHRP, THEN ONE COULD ARGUE THAT
THAT WOULD BE AN APPROPRIATE WAY
TO HELP THE REGULATED COMMUNITY
BUT THERE'S THE RESOURCE
ALLOCATION QUESTIONS, WHETHER
THAT'S BEST USE OF RESOURCES.
ULTIMATELY, I'LL JUST TELL YOU
AS AN ECONOMIC -- MACROECONOMIC
MATTER, HAVING THE SINGLE IRB BE
RESPONSIBLE REALLY DRIVES THIS
CENTRALIZATION OF IRBs EVEN
MORE BECAUSE ONLY A FEW IRBs
HAVE THE CAPACITY TO HAVE ACCESS
TO ALL THE INFORMATION THAT THEY
WOULD NEED SO DISINCENTIVIZES
SMALLER INSTITUTIONAL IRBs
FROM BEING SINGLE IRBs, IN
MULTI-SITE STUDIES, THE REAL
WORLD FACT OF THE WAY THIS PLAYS
OUT.
ANY REGULATED INDUSTRY, MORE
HIGHLY REGULATED, THE MORE
CENTRALIZED IT BECOMES BECAUSE
OF TRANSACTION COST OF DEALING
WITH REGULATIONS.
THAT'S AN ECONOMIC PHENOMENON.
>> I COULDN'T AGREE MORE, MARK.
THAT WAS THE SPIRIT OF HAVING
THIS SUPPORTED THROUGH OHRP.
LOIS, I TAKE THE POINT ABOUT
RESOURCING, I'M ALSO THE ETERNAL
OPTIMIST, HOPING I.T. COSTS WILL
GO DOWN FOR THIS SORT OF
ACTIVITY FUTURE.
>> MY OTHER TAKEWAY FROM READING
THE DOCUMENT
I'M NEW TO SACHRP, MY FIRST
IN-PERSON MEETING.
WHAT DO WE KNOW ABOUT HOW THINGS
ARE GOING WITH THE SINGLE
IRBs?
YOU KNOW, SO, MARK, YOU'RE
TELLING US LIKE THIS IS WHAT'S
HAPPENING, WHAT THE EFFECTS
WOULD BE, WHAT'S HAPPENING ON
THE GROUND.
I'M JUST WONDERING WHAT I WAS
THINKING WHEN I SAW THAT
PROPOSED, YOU KNOW, LOCAL IRBs
HAVE BEEN HAVING TO FIGURE OUT
WHAT THE LAWS ARE ALL THE TIME,
YOU KNOW.
AND CAN'T SINGLE AND LOCAL JUST
WORK THAT OUT?
SO THAT WAS KIND OF MY BEGINNING
POINT BUT MY OTHER POINT WAS
THINKING ABOUT WHAT OTHER KIND
OF THINGS WE WOULD LIKE OHRP TO
DO OR KNOW ABOUT OR WHAT SHOULD
BE FUNDED, IT SEEMS TO ME, YOU
KNOW, SOME KIND OF REPORT ABOUT
HOW THE SINGLE IRB SYSTEM IS
GOING, INTENDED AND UNINTENDED
CONSEQUENCES, AND JUST A FACTUAL
WHERE ARE THINGS?
AND, YOU KNOW, SO IF THAT
ALREADY EXISTS, POINT ME TO IT.
BUT, YOU KNOW, I PEER REVIEWED
SOMETHING RECENTLY, I KEPT ON
SAYING WHERE'S THE DATA ON WHAT
YOU'RE TALKING ABOUT?
THAT'S WHAT I -- I'M CURIOUS IF
ANY OF YOU KNOW, I MEAN, DO WE
HAVE A GOOD UNDERSTANDING --
DOES OHRP HAVE A GOOD
UNDERSTANDING RIGHT NOW OF WHAT
HAS HAPPENED SINCE THE SINGLE
IRB MANDATE WITH RESPECT TO
CONSOLIDATION, WITH RESPECT TO
PRIVATE/PUBLIC IRBs, YOU KNOW,
WITH RESPECT TO THOSE CONNECTED
TO ACADEMIC INSTITUTIONS VERSUS
NOT, AND JUST KIND OF HOW'S IT
GOING?
YOU KNOW, SEEMS LIKE THAT WOULD
BE GOOD INFORMATION TO KNOW.
IF WE ALREADY KNOW IT, LET ME
KNOW.
SOMEONE POINT ME TO THAT
RESOURCE.
>> I MEAN, OHRP IS WELCOME TO
COMMENT.
NIH, IF IT'S IN THE ROOM OR ON
THE ZOOM, IS OBVIOUSLY -- WE
WOULD LOVE TO HEAR THE COMMENTS.
I DON'T THINK THERE'S BEEN A
COMPREHENSIVE DATA ANALYSIS OF
WHAT THE EFFECT IS.
I DO THINK WHAT I GET, MY
IMPRESSIONS FROM JUST BEING
ASKED ABOUT THINGS, I DO THINK
THAT THE FACT THAT INDUSTRY
SPONSORS OF CLINICAL RESEARCH
INCREASINGLY HAVE DEMANDED
SINGLE IRBs AS A CONDITION OF
A SITE BEING BROUGHT ON AS A
SITE, IN ADDITION TO THE NIH AND
THE COMMON RULE MANDATE HAS LED,
IN MY IMPRESSION, FOR WHAT IT'S
WORTH, IT HAS LED TO A LOT OF
OPPORTUNITY FOR THE COMMERCIAL
CENTRAL IRBs AS WELL AS
OPPORTUNITY FOR THE
WELL-ESTABLISHED ACADEMIC IRBs
IN THE LARGEST INSTITUTIONS TO
BECOME THE CENTRAL IRBs, BUT
I DON'T THINK THERE'S BEEN A
SURVEY DONE, JUST GIVING MY
EXPRESSION.
SKIP?
>> FOR MANY YEARS, MANY ACADEMIC
INSTITUTIONS HAVE BEEN
OUTSOURCING IRB REVIEWS FOR
PHARMACEUTICAL STUDIES FOR
EXAMPLE.
I SUSPECT THE ANSWER TO YOUR
QUESTION WILL DEPEND LARGELY ON
TYPE OF STUDY.
COMPLEXITY, IT'S NOT WITHOUT
NOTICE KINDS OF EXAMPLES GIVEN
HERE HAVE BEEN ABOUT WHERE THIS
COULD BE PROBLEMATIC, HAVE
BEEN -- STUDIES THAT INVOLVE
VULNERABLE POPULATIONS,
DIFFICULT TOPICS, WHERE THERE'S
A LOT OF LOCAL VARIABILITY IN
LAWS, PRACTICES, ET CETERA.
WHICH DOESN'T REALLY APPLY TO
PHARMACEUTICAL STUDIES SO I
THINK THE ANSWER TO THE QUESTION
WILL DEPEND IN LARGE PART ON
TYPE OF STUDY YOU'RE LOOKING AT
SO I DON'T THINK ONE SIZE WOULD
FIT ALL.
>> YES?
>> YEAH, PLEASE, JERRY.
>> YEAH, I PROBABLY AGREE WITH
SKIP'S POINT, IN TERMS OF
FEDERALLY FUNDED STUFF AND
NON-FEDERALLY FUNDED STUFF.
JUST IN TERMS OF, YOU KNOW, OHRP
PROBABLY DOESN'T HAVE A LOT OF
INFORMATION ABOUT THIS.
IT'S IN THE NATURE OF WHAT
INFORMATION ACTUALLY OHRP HAS
READY ACCESS TO AND BY AND LARGE
WE ACTUALLY DON'T, I MEAN WE
DON'T -- YOU KNOW, WE'VE
ADMINISTER RULES, BUT DAY TO DAY
WE DON'T CREATE IRBs OR HAVE
OUR OWN IRBs DOING STUFF.
WHETHER NIH PEOPLE HERE WANT TO
COMMENT ON THAT, YOU KNOW, IT'S
UP TO THEM.
IN FACT MY RECOLLECTION GOING
BACK TO THE COMMON RULE WAS
REVIEWED THERE WERE ISSUES
RELATING AND FOLLOW WHERE NIH
INDICATED AND PROBABLY HAS BEEN
DOING FROM TIME TO TIME, VARIOUS
ATTEMPTS TO SEE HOW THE SYSTEM
IS WORKING.
I'LL REMIND SOME OF YOU WHEN WE
WERE CRAFTING THE REVISIONS TO
COMMON RULE IT WAS LIKE PULLING
TEETH IN TERMS OF A FEW MINOR
THINGS OHRP WOULD LIKE THIS TINY
PIECE OF INFORMATION THAT WOULD
TAKE AN INSTITUTION FIVE MINUTES
A YEAR AND THESE BY AND LARGE
WERE PULLED OUT OF THE REVISIONS
TO THE RULE THAT THIS IS TOO
MUCH WORK SO BOTTOM LINE HORN IN
OHRP DOES NOT HAVE ACCESS TO
THE INFORMATION THAT WOULD TELL
YOU HOW THESE CHANGES, GOOD OR
BAD, AGAIN, OTHER PLAYERS MAY
CERTAINLY KNOW MORE,
PARTICULARLY IN TERMS OF NIH.
CERTAINLY AGREE THE MORE
INFORMATION YOU GET ABOUT A
SYSTEM, THIS WOULD BE GREAT BUT,
AGAIN, THIS IS PART OF WHAT
HAPPENED BEFORE, REVISING THE
COMMON RULE.
I THOUGHT A BIG THEME IN TERMS
OF OUR SIDE WE DON'T ACTUALLY
HAVE A LOT OF INFORMATION ABOUT
HOW THE SYSTEM WORKS AND WERE
TRYING TO COLLECT MORE AROUND
WEREN'T GIVEN THE AUTHORITY TO
DO THAT.
AND IT WAS NOTEWORTHY FROM MY
END HOW MUCH THERE WAS PUSHBACK
IN SAYING, YOU KNOW, EVEN IN
TERMS OF THINGS THAT WEREN'T
GOING TO TAKE OF TIME OR EFFORT
AT ALL WE WEREN'T ALLOWED TO DO
THAT.
THE OTHER ISSUE RAISED IN TERMS
OF THIS TOPIC AND PRIOR ONE, OUR
BUDGET.
WE ARE SMALL.
DOING MANY THINGS THAT YOU GUYS
HAVE TALKED ABOUT HERE ARE GOING
TO TURN INTO HOW SMALL THEY ARE
AND EFFORT THAT'S INVOLVED,
PEOPLE POINTED OUT INTERNATIONAL
COMPILATION, FOR EXAMPLE, WHICH
ACTUALLY IS A BIG EFFORT THAT WE
ACTUALLY TALK ABOUT WHETHER OR
NOT WE COULD MAINTAIN DOING THAT
BUT THAT'S RELATIVELY EASY IN
TERMS OF WHAT OHRP PRETTY MUCH
DOES, HAS CONTEXTS IN A BUNCH OF
COUNTRIES AND ONCE A YEAR ASK
THEM COULD YOU SHIP US JUST A
DOCUMENT, THE LAWS, THAT'S MIND
BOGGLING DIFFERENT AND BY AND
LARGE, NOT JUST OHRP BUT OTHER
PARTS OF THE FEDERAL GOVERNMENT
IN GENERAL, IT'S NOT THE
BUSINESS OF MOST PARTS OF THE
FEDERAL GOVERNMENT TO DELVE INTO
TELLING PEOPLE WHO ARE SUBJECT
TO STATE AND LOCAL LAWS HERE IS
THE FEDERAL GOVERNMENT HELPING
YOU OUT TO COMPLY WITH STATE AND
LOCAL LAWS.
WHICH OF COURSE, AGAIN, YOU
SHOULD MAKE WHATEVER
RECOMMENDATION YOU WANT BUT
REALISTICALLY SPEAKING I DON'T
SEE ANYBODY IS GOING TO GIVE US
A VAST AMOUNT OF MONEY THAT
WOULD BE REQUIRED TO DO THIS.
I'M CURIOUS, MARK, I SUSPECT IT
WASN'T A TINY MATTER OF MONEY
THAT WAS INVOLVED WHEN SUSAN
WOLFE --
>> IT WAS A LARGE GRANT, A
FIVE-YEAR GRANT THAT TOOK A LOT
OF TIME AND TROUBLE.
>> THAT'S JUST THE REALITY OF
WHERE THINGS ARE AT.
WE CAN ENDORSE THE GOAL OF
GETTING MORE INFORMATION ABOUT
ALL OF THIS, I PERSONALLY THINK,
AND OHRP HAS BEEN BEHIND
UNDERSTANDING MORE ABOUT THIS
SYSTEM.
ABSOLUTELY.
IT'S JUST A QUESTION OF HOW DO
YOU GET THERE.
AND WHO IS GOING TO PAY FOR IT,
ET CETERA, ET CETERA.
AGAIN, WE'RE A RELATIVELY SMALL
PLAYER, JUST IN TERMS OF OUR
BUDGET.
>> LOIS, JUST TO BUILD ON WHAT
YOU SAID, AND WHAT JERRY SAID, I
THINK MY OTHER IMPRESSION IS
THAT IN MANY AREAS A SINGLE IRB
MANDATE HAS BEEN VERY USEFUL
BECAUSE IT HAS EXPEDITED
RESEARCH AND MADE REVIEW OF
RESEARCH MORE PROFESSIONAL,
HIGHLY CENTRALIZED IRBs THAT
HAVE SUFFICIENT STAFF TO LOOK
EXTREMELY CAREFULLY AT THESE
PROTOCOLS.
YOU ALSO GET ADVERSE EVENT
REPORTING THAT IS UNIFIED TO ONE
IRB WHICH MEANS THE SINGLE IRB
IS ABLE TO UNDERSTAND WHAT'S
HAPPENING ACROSS ALL THE SITES
RATHER THAN JUST ONE SITE IN
REAL TIME.
SO THERE'S A LOT OF ADVANTAGES
TO IT.
AND I THINK WHAT WE HAVE FOCUSED
ON IN THIS AS WE FOCUSED ON FOUR
YEARS AGO ARE CIRCUMSTANCES
WHICH A SINGLE IRB MAY NOT BE
THE OPTIMAL WAY TO GO.
AND SO I THINK IT'S A BIG
UNIVERSE OUT THERE IN SOME WAYS
IT'S BEEN EXTREMELY USEFUL.
ESPECIALLY THE COVID VACCINE
STUDIES AND COVID TREATMENT
STUDIES, THERE HAVE BEEN LIKE 25
OR 50 IRBs WRITING HERD THEY
WOULD NEVER HAVE BEEN DONE AS
QUICKLY AS THEY WERE DONE, TO
GIVE AN EXAMPLE, FOR WHAT IT'S
WORTH.
>> TWO COMMENTS.
ONE IS I JUST DID A QUICK SEARCH
TO SEE IF THERE WAS EMPIRICAL
LITERATURE ABOUT THE FUNCTIONING
OF SINGLE IRBs, IT TURNED UP
AN ARTICLE, WHEN IRBs SAY NO
TO PARTICIPATING IN RESEARCH
ABOUT SINGLE IRBs.
SO, WE DON'T APPEAR TO KNOW A
LOT ABOUT HOW THIS IS WORKING.
AND THE OTHER IS JUST I SECOND
WHAT JERRY SAID.
YOU KNOW, EVEN APART FROM OHRP
BEING SMALL, THE SECTION AT 172
AND BEYOND, AS I READ THAT I
THOUGHT THAT'S SO DIFFICULT FOR
ANYBODY TO DO, NOT ONLY BECAUSE
COMPILING IS DIFFICULT BUT
BECAUSE STATE LAW CHANGES ON A
DIME IN 50 DIFFERENT PLACES AND
STATE LAWS ARE NOT LIKE ONE
STATE LAW.
YOU HAVE TO DRAW FROM A BUNCH OF
THEM.
SO TRYING TO KEEP THESE CURRENT
IS ALMOST A BIGGER CHALLENGE
THAN COMPILING.
I DON'T KNOW HOW YOU WOULD DO
THAT.
THERE ARE A FEW FOUNDATIONS THAT
DO THAT FOR LIKE LAWS RELATED TO
MINORS, INFORMED CONSENT, FOR
EXAMPLE, BUT EVEN THOSE ARE
DIFFICULT TO KEEP UP TO DATE.
>> DOUG, A QUESTION.
SHOULD WE WALK LACK LINE 172, IN
THE INTEREST OF DAVID AND MARK
HAVING A FINAL DOCUMENT, BECAUSE
IT SAYS SACHRP RECOMMENDS, ET
CETERA, ET CETERA.
SOUND LIKE THERE'S A FAIR AMOUNT
OF DISCUSSION OF THE DOUBTS
AROUND THAT EVEN THOUGH THERE'S
USEFULNESS FOR SUCH A PRODUCT
BUT DOUBTS WE SHOULD -- WHY
RECOMMEND SOMETHING WE DON'T
THINK IS EVER GOING TO HAPPEN I
GUESS IS THE QUESTION.
>> YEAH, AND I GUESS I WOULD --
YEAH, I'D BE INTERESTED TO SEE
WHAT OTHERS LIKE LINDA HAVE TO
SAY.
I THINK IT'S A GREAT IDEA.
I JUST DON'T KNOW HOW TO
IMPLEMENT.
WE PROBABLY SHOULDN'T BE
RECOMMENDING SOMETHING WE DON'T
HAVE A SUGGESTION FOR HOW TO
REASONABLY IMPLEMENT IT.
LINDA?
>> I WAS GOING TO SUGGEST THAT I
WOULD NOT RECOMMEND ELIMINATING
IT BUT CHANGING THE LANGUAGE TO
WHAT WE HAD ORIGINALLY TALKED
ABOUT, DAVID, YOU COULD SAY THAT
AGAIN, WE TALKED ABOUT WE SHOULD
CONSIDER SOMETHING LIKE THE
INTERNATIONAL COMPILATION OR
SOMETHING THAT LOIS HAD
MENTIONED, I THINK SEVERAL OF US
HAD MENTIONED OPTIONS THAT COULD
BE DONE, WE CAN'T REALLY SOLVE
THE PROBLEM, WHAT WE WANT TO
RECOMMEND IS THERE NEEDS TO BE
SOMETHING IN PLACE, WHAT WE WANT
TO RECOMMEND.
THIS COULD BE IN THE FORM OF
SUCH AS THESE THINGS, I WOULD
LIST IT, IT COULD SAY
RECOGNIZING THERE ARE FUNDING
AND OTHER ISSUES BUT HERE IS HOW
WE RECOMMEND SOMETHING BEING
LOOKED AT.
I THINK THAT'S GOING TO BE
REALLY IMPORTANT JUST BECAUSE
THOSE OF US ON THE GROUND DOING
THE WORK I MEAN I DON'T CARE
WHERE IT COMES FROM BUT I WOULD
THINK MOST INSTITUTIONS OR
ORGANIZATIONS EVEN LOCAL IRBs
COMMERCIAL OR OTHERWISE WOULD
APPRECIATE THAT.
IT'S NOT A QUESTION OF
INTERPRETING LAW, BUT GIVING
INFORMATION, YOU STILL HAVE A
DUTY TO GET IN THE WEEDS ABOUT
WHAT YOU LAW MEANS AND HOW TO
INTERPRET.
AGAIN, I THINK THAT YOU NEED TO
HAVE A STARTING POINT.
I THINK IT'S REALLY IMPORTANT
BECAUSE OTHERWISE IT COULD BE A
SITUATION WHERE THEN, YOU KNOW,
IT'S AN UNFUNDED MANDATE AND
YOU'RE REQUIRING THIS TO HAPPEN
BUT THEN YOU'RE NOT SUPPLYING
IDEAS HOW TO SOLVE THE PROBLEM.
THAT'S JUST MY RECOMMENDATION.
>> KEVIN HAS BEEN PATIENT.
MY ONLY COMMENT, WE'VE
RECOMMENDED MAYBE THINGS OVER
THE YEARS WE WERE SURE WEREN'T
GOING ANYWHERE, I DON'T KNOW
THAT SHOULD BE A DISINCENTIVE TO
SAYING THIS IS WHAT WE THINK.
THAT'S MY TWO CENTS.
KEVIN?
>> THANKS.
THIS IS AN INTERESTING
DISCUSSION.
IT SEEMS LIKE AT BASE WE'VE GOT
SOME RECOMMENDATION THAT WE'RE
CONSIDERING TO SAY ADDITIONAL
RESOURCES SHOULD BE PROVIDED BY
HHS TO HELP THIS OUT IN SOME
WAY.
AND I WAS THINKING ABOUT WHAT
MARK WAS SAYING ABOUT THE
MACROECONOMIC PICTURE, AM I
RIGHT THERE'S AN ASSUMPTION
WE'RE ASKING FOR RESOURCES
BECAUSE ADDITIONAL RESOURCES
WERE NOT PUSHED INTO THE SYSTEM
THE WAY IT'S GOING TO GO
NATURALLY IS LARGE COMMERCIAL
IRBs AND LARGE ACADEMIC
INSTITUTIONS THAT DO THE VOLUME
OF THE WORK CAN AFFORD TO DO
THIS THEMSELVES WILL PUSH
CENTRAL IRB WORK TO THOSE TYPES
OF PLACES.
SO IF I'M AT HHS THOUGH I MIGHT
SAY WHAT'S WRONG WITH THAT?
AND SO IT SEEMS LIKE THERE'S AN
ASSUMPTION ASKING FOR RESOURCES
THAT THE PICTURE OF WHAT'S GOING
TO HAPPEN ABSENT THE RESOURCES
IS A BAD PICTURE, I'M NOT SAYING
ALSO A GOOD -- IT'S GOOD OR BAD,
THAT SEEMS TO BE UNDERLYING THE
SUGGESTION MORE RESOURCES BE
PUSHED, IF THAT'S AN ASSUMPTION,
WHAT IS THE VALUE HAVING A LOT
OF VARIETY OF SITES ABLE TO
PARTICIPATE IN SINGLE IRBs, IS
THERE VALUE IN THAT OR IS THAT
ACTUALLY INEFFICIENT?
I DON'T KNOW THE ANSWER TO THAT
BUT IT SEEMS LIKE A CRITICAL
ASSUMPTION UNDERLYING THE
SUGGESTION MORE RESOURCES NEED
TO COME INTO THE SYSTEM.
>> ONE THING ABOUT -- I'MING A
-- I'M AGNOSTIC.
BUT THERE IS ANOTHER AUDIENCE
FOR A RESOURCE LIKE THAT, THAT
IS INVESTIGATORS TRYING TO PLAN
STUDIES, MULTI-SITE STUDIES,
BEING ABLE TO PROPOSE STUDIES
THAT ARE CONSISTENT WITH LOCAL
LAW SO THERE IS ANOTHER USER
POPULATION.
I DON'T WANT US TO LOSE SIGHT.
TO RESOLVE THIS WE'LL TAKE OUT
THAT SACHRP SHOULD DO THIS.
I'M PROPOSING THIS.
WE'LL TAKE OUT SACHRP, SHOULD
JUST SAY THERE'S VALUE IN HAVING
A CENTRALIZED RESOURCE THAT
WOULD BE KEPT AND UPDATED, MAY
BE POSSIBLE TO DO IT THROUGH
TROLLING OR AI MECHANISMS IN A
MORE EFFICIENT WAY THAN HUMANS
ONE BY ONE AND IT WOULD EMPOWER
SOME IRBs THAT MIGHT NOT
OTHERWISE HAVE ACCESS TO SERVE
AS CENTRAL IRBs AND EMPOWER
INVESTIGATORS AT ALL
INSTITUTIONS TO BE ABLE TO PLAN
THEIR STUDIES IN A WAY IN --
MORE IN TUNE TO LOCAL
REQUIREMENTS, PUBLIC/PRIVATE
PARTNERSHIP, ENTIRELY PRIVATE,
NOT FOR PROFIT, ANYTHING, BUT IT
WOULD BE USEFUL.
>> WE COULD TAKE OUT OHRP.
YOU MEANT SACHRP.
>> I MEANT OHRP.
WOULD NOT SAY OHRP HAS TO DO IT.
IS THAT OKAY WITH EVERYBODY?
>> THAT'S WHAT WE'LL DO.
>> GREAT.
>> ALL RIGHT.
THE LAST SECTION OF THE DOCUMENT
HAS TO DO WITH EXCEPTIONS TO
SINGLE IRB REQUIREMENT AND AS WE
NOTED IN THE BEGINNING, INCLUDED
WITH THE DOCUMENT, WE MADE
RECOMMENDATIONS, WE, SACHRP, YOU
MADE RECOMMENDATIONS IN 2018
ABOUT THIS REQUIREMENT AND
RECOMMENDED THREE CATEGORIES,
THREE TYPES OF EXCEPTIONS, AS
POTENTIALLY APPROPRIATE RESEARCH
INVOLVING LIMITED NUMBER OF
SITES, FIVE OR FEWER, RESEARCH
FOR WHICH REVIEW BY SINGLE IRB
IS UNABLE TO MEET NEEDS AND
INVOLVING POLITICAL CONTROVERSY
OR SENSITIVE ISSUES, LOCAL
IRBs WOULD BETTER ADDRESS
THOSE CONCERNS.
AND SO WE BELIEVE THIS DRAFT
GUIDANCE WOULD BENEFIT BY HAVING
A DISCUSSION ABOUT EXCEPTIONS
AND OFFERING ADDITIONAL
OFF-RAMP, SO TO SPEAK, FOR
STUDIES OR SITES FROM THE
REQUIREMENT.
>> DAVID, THIS GOES BACK TO THE
PROCESS WE TALKED ABOUT, BUT
ALSO LOOKING AT NUMBER 3 AGAIN,
I WOULD SUGGEST GETTING RID OF
POLITICAL AND SAY CONTROVERSIAL
AND SENSITIVE.
THAT'S WHAT IT EVENTUALLY
BECOMES.
>> YOU'RE IMPOSSIBLE TO HEAR.
CAN YOU PLEASE SPEAK INTO YOUR
MIC?
THANK YOU.
>> SORRY.
SO NUMBER 3, I WOULD GET RID OF
THE WORD POLITICAL.
DIFFERENCES MAY THEN CREATE A
CONTROVERSIAL, COULD AT ITS ROOT
BE RELATED TO POLITICAL ISSUES
BUT IT DOESN'T ADD ANYTHING TO
THE DOCUMENT.
I WOULD JUST GO CONTROVERSIAL OR
SENSITIVE.
WE CAN ALL DEBATE ABOUT THE
POLITICS OF DIFFERENT
CONTROVERSIAL OR SENSITIVE
ISSUES.
>> WALTER?
>> I DO THINK HAVING SOME
GRANULARITY HERE WOULD BE
HELPFUL.
I DON'T NECESSARILY AGREE THAT
HAVING POLITICAL OR
CONTROVERSIAL OR APPROPRIATE
TERMS BUT I THINK SOME GRANT
LATER WOULD BE HELPFUL BECAUSE
I'M THINKING IN PARALLEL THAT IT
MIGHT BE HELPFUL TO PROVIDE SOME
GUIDANCE THAT THE IRB REVIEW
SHOULD BE FOCUSED OR RESTRICTED
TO THOSE PARTICULAR TOPICS THAT
MAKE THE REVIEW, THAT SUPPORT
THIS EXCEPTION.
IN ORDER TO, AS MUCH AS
POSSIBLE, SEE THAT THE REVIEW IS
RESTRICTED TO THOSE AREAS,
ALLOWS AN EFFICIENT WAY OF
DETERMINING WHETHER OR NOT THE
INTEGRITY OF THE STUDY IS
POTENTIALLY, YOU KNOW, IS
POTENTIALLY COMPROMISED OR
WHETHER IT COULD BE REMEDIATED.
AND THINKING MORE FROM THE
PRIVATE SECTOR SPONSOR
PERSPECTIVE WITH FOCUS ON
DESIGNING STUDIES THAT HAVE
CERTAIN LEVELS OF HOMOGENEITY
FOR REGULATORY PURPOSES.
OVER.
>> WALTER, LET ME PUT YOU ON THE
SPOT.
I'M GOING TO ASK YOU TO BE
SPECIFIC HOW YOU CHANGED THE
WORDING HERE.
IF I'M HEARING YOU, YOU WANT
MORE GRANULARITY WITH REGARD TO
ITEM 3 THERE, CONTROVERSIAL AND
SENSITIVE ISSUES, BUT
SPECIFICALLY HOW WOULD YOU ADD
THAT OR WORD THAT SINCE WE
REALLY DO NEED TO.
>> MIC.
>> SORRY.
>> WE TRIED CULTURAL BEFORE.
THAT WAS -- THERE ARE ISSUES
RELATED TO PERHAPS LOCAL NORMS
AND VALUES.
THERE ARE -- THOSE ARE TWO TO
COME TO MIND IMMEDIATELY.
>> GO AHEAD, SKIP.
>> I GUESS I DON'T SEE IT ADDING
ANY MORE SPECIFICITY.
I MEAN, IN OTHER WORDS, WE CAN
SAY TODAY THIS IS A
CONTROVERSIAL ISSUE, AND IT
COULD BE RELATED TO POLITICAL
DIFFERENCES, CULTURAL
DIFFERENCES, DIFFERENCES AT A
LOCAL LEVEL FOR X, Y OR Z AND
TEN YEARS FROM NOW THAT SAME
ISSUE MAY NOT BE CONTROVERSIAL
ANYMORE.
SO I'M NOT SURE WE GAIN ANY MORE
SPES SPECIFICITY BY ADDING
BUZZWORDS AROUND ROOTS OF
DIFFERENCES OTHER THAN TO SAY
CONTROVERSIAL OR SENSITIVE.
>> SKIP, SO I UNDERSTOOD, YOU
AGREED WITH THE TERM
CONTROVERSIAL OR DISAGREED?
>> I AGREE.
I JUST DON'T THINK POLITICAL
ADDS ANY DEPTH TO CONTROVERSIAL
OR SENSITIVE.
THAT'S ALL.
>> SO THE WORD WOULD GO LIKE IT
IS UP THERE -- WORDING WOULD BE
RESEARCH INVOLVING CONTROVERSIAL
OR SENSITIVE ISSUES WHICH WOULD
PRESUMABLY BE --
>> THE ROOT COULD BE VARIABLE.
>> YES, THAT'S FINE, DOUG.
>> THANK YOU.
>> OTHER COMMENTS OR QUESTIONS
HERE?
>> LOIS?
>> SORRY.
>> I THINK ON MINE 191 YOU MIGHT
BE MISSING A WORD.
I THINK IT'S SUPPOSED TO BE
SINGLE IRB REVIEW.
THE LINES ARE DIFFERENT NOW.
OKAY.
>> WHAT'S THE SENTENCE?
>> SORRY.
YES.
THAT'S IT.
>> OTHER COMMENTS?
>> YEAH, GO AHEAD, SKIP.
>> SO MY QUESTION TO MARK AND
DAVID, I'M ASSUMING THIS IS
WHERE I WOULD ADD SOME OF THE
PROCESS COMMENTS.
I MEAN, WE HAD THAT DISCUSSION A
WHILE AGO BUT I THINK STIMULATED
AT LEAST IN MY VIEW OF ASKING
HOW DO YOU MAKE A DECISION AS TO
WHETHER THIS IS AN EXCEPTION.
SO THIS IS WHERE I PERSONALLY
WOULD ADD A COUPLE SENTENCES
AROUND THAT PROCESS TO THE
DOCUMENT.
I DON'T KNOW IF OTHERS SEE A
DIFFERENT PLACE FOR IT.
>> SKIP, I THINK IT COULD GO
HERE AND IT COULD GO -- NO
PROBLEM WITH PUTTING IT IN
TWICE, YOU KNOW.
>> OKAY.
>> FROM MY POINT OF VIEW.
>> AND I KNOW WE HAD A TIME SET
ASIDE AT THE END FOR PUBLIC
COMMENT BUT THAT DOESN'T HELP
MUCH IN IT'S RELATED TO THIS.
WE HAD ONE PUBLIC COMMENT
E-MAILED TO ALL OF YOU BUT I'M
GOING TO READ IT SO IT'S ON THE
RECORD AND YOU'RE AWARE OF IT.
AND THIS PARTICULAR PERSON I
THINK HAS REALLY TWO COMMENTS.
FIRST IS ASKING WHETHER IT'S
POSSIBLE FOR SACHRP TO COMMENT
ON OR RECOMMEND A STANDARDIZED
LOCAL CONTEXT FORM TO BE ADAPTED
TO RESEARCH BEING CONDUCTED FOR
USE WHEN A SINGLE IRB STRUCTURE
IS REQUIRED BY THE REGS, THIS
TYPE OF PRACTICAL DOCUMENT IS A
WAY FOR THE LOCAL SITE TO ENSURE
THAT THE REVIEWING IRB IS AWARE
OF ALL THE APPLICABLE LAWS AND
LOCAL ETHICAL CONSIDERATIONS.
AND THEN THE SECOND COMMENT IS A
COMMENT ON TIMING OF LOCAL
CONTEXT SCOPING, TIMING OF THE
DECISIONS ABOUT EXCEPTIONS, ET
CETERA, ALSO NEEDED, SINCE
APPLICATIONS SUBMITTED TO
FUNDING AGENCIES ARE BUDGETED
ACCORDING TO REVIEW STRUCTURE.
AND IF IT'S POSSIBLE TO ADDRESS
PRIOR TO AWARD, THEN FLEXIBILITY
IS WARRANTED FOR MOST
STAKEHOLDERS TO ADJUST
ACCORDINGLY.
>> DOUG, I WOULD NOT RECOMMEND
THAT YOU RECOMMEND THAT THERE BE
ONE FORM, BUT I THINK IT WOULD
BE POTENTIALLY USEFUL TO PUT IN
THAT ONE METHOD BY WHICH A
CENTRAL OR SINGLE IRB MIGHT
SOLICIT COMMENT AND INFORMATION
IS BY USING ITS OWN STANDARDIZED
FORM AS A BASELINE THAT WOULD BE
USEFUL IN SOLICITING PARTICULAR
INPUT ABOUT MAKING IT
STANDARDIZED ACROSS STUDIES.
THAT'S ONE THING WE COULD SAY.
I THINK THE SECOND THING, SECOND
COMMENT THE COMMENTER IS TALKING
ABOUT, I THINK THAT WILL
ACTUALLY BE PROBABLY FOLDED INTO
THE PROCESS POINTS THAT SKIP
NELSON COULD MAKE.
>> HOW WOULD THE STANDARDIZATION
PLAY INTO THE SMART IRB
PLATFORMS THAT ARE MOST
FREQUENTLY USED FOR THIS
MECHANISM?
>> THAT OF THEY WOULD NEED TO
THINK ABOUT WHETHER THEY COULD
USE AND COULD HAVE A
STANDARDIZED FORM AS PART OF
THEIR PROCESS, PART OF THE
ELECTRONIC APPLICATION PROCESS.
SO, LIKE ANYBODY COULD.
WCG OR ANYTHING, YOU KNOW.
I'LL PUT THAT IN IF YOU GUYS ARE
IN AGREEMENT ON THAT.
>> OKAY.
>> WE'RE AT THE END OF THIS
DOCUMENT.
>> DAVID BORASKY, I THINK WHAT
YOU AND I COULD TRY TO DO IS
OVERNIGHT TRY TO PUT THIS
DOCUMENT IN BETTER SHAPE, I MEAN
IN SHAPE.
THERE'S NOT MUCH TO DO.
THERE'S SOME TO DO BUT LOIS HAS
MADE SOME SPECIFIC WORDING
SUGGESTIONS AND AND SO HAS
LINDA.
IF IT'S OKAY WITH DOUG YOU AND I
COULD WORK ON THIS AND TOMORROW
YOU COULD PRESENT THE RED LINE
VERSION OF IT.
I WON'T BE HERE.
>> YEAH, I THINK THAT'S
REASONABLE.
>> OKAY.
>> DOUG, CAN WE TAKE A
FIVE-MINUTE BREAK?
>> YES, WAS THERE ANYTHING ELSE
ON THIS ITEM BEFORE WE TAKE A
FIVE-MINUTE BREAK?
IT WOULD BE NICE IF WE CAN GET
THIS APPROVED TOMORROW.
IF WE CAN'T, WE MISS THE
OPPORTUNITY TO COMMENT.
OKAY.
LET'S TAKE FIVE OR TEN MINUTES.
WE CAN JUST COME BACK AT NOON
WHEN THE NEXT ITEM IS SCHEDULED.
SO TEN-MINUTE BREAK.
SO, WE HAVE ABOUT AN HOUR NOW TO
DISCUSS INTERPRETING ENGAGEMENT
IN HHS CONDUCTED RESEARCH.
>> I'M WONDERING WHY I'M NOT
SEEING ZOOM MEMBERS ON ZOOM, IF
THAT'S AN I.T. THING.
>> YEAH, GOOD POINT.
>> WHERE ARE I.T. ANGELS WHO I'M
SURE HEAR ME?
WHY DON'T YOU CONTINUE AND I'LL
GO.
>> THEY DIDN'T RESPOND.
>> WE'RE HERE.
EVERYONE IS HERE.
>> WE'RE HERE.
>> WHERE DID MY ZOOM PEOPLE GO?
>> SO, WE DON'T HAVE THEIR
PICTURE UP.
THEY ARE APPARENTLY PRESENT.
>> OKAY.
>> THERE'S CONSUELO.
OKAY, GOOD.
>> OKAY.
>> ALL RIGHT.
WE'LL TRY TO GET THE PICTURE SO
WE CAN ACTUALLY SEE YOU, SO WHEN
YOU HAVE COMMENTS AND RAISE YOUR
HANDS WE KNOW IT.
BUT MARK BARNES IS GOING TO
PRESENT THIS.
AND WE HAVE VISITED THIS POLICY
SEVERAL TIMES NOW IN OUR HOPE AS
WITH OUR PREVIOUS ITEM, THAT WE
CAN GET AN APPROVAL ON THIS
TODAY, SO AS MARK PRESENTS THIS,
COMMITTEE MEMBERS MAKE COMMENTS,
THE MORE SPECIFIC WE CAN BE LIKE
DOWN TO THE LEVEL OF WORDING
CHANGES, THE MORE HELPFUL IT
WOULD BE TO GET THIS MOVING
FORWARD.
SO, MARK, WHEN YOU GET THE
PODIUM I'M GOING TO LET YOU TAKE
US THROUGH THIS.
GREAT.
THANK YOU.
WE CAN SEE OUR OTHER MEMBERS
NOW.
>> CAN I ASK IF PEOPLE ON THE
ZOOM CAN SEE THE POWERPOINT
WELL?
MARY ELLEN?
>> YES.
>> CONSUELO?
>> WE'RE JUST SEEING A SCREEN
WITH ONE SLIDE.
THAT'S THE --
>> THAT'S ALL.
>> SO THE INTRO SLIDE.
>> THAT'S FINE.
I HAVEN'T CHANGED SLIDES YET.
>> OKAY, GOT IT.
>> OKAY.
SO, THANK YOU, DOUG.
SO.
>> WE'RE SEEING THE COMMITTEE,
NOT YOUR INTRO SLIDE.
>> YOU'RE NOT SEEING MY INTRO.
HOLD ON, I'M SORRY.
HOLD ON.
WHAT ARE YOU SEEING NOW?
>> STILL THE COMMITTEE SLIDE.
THE POWERPOINT WITH JUST ONE
SLIDE THAT SAYS THE INTRO.
THERE WE GO.
>> DO YOU SEE IT NOW?
>> YES.
>> OKAY, GREAT.
EXCELLENT.
THANK YOU, DOUG.
SO, LOOK, I'M NOT GOING -- I'M
GOING TO TELL YOU CERTAIN THINGS
BUT I'M NOT GOING TO GO THROUGH
ALL OF THE ISSUES, ALL OVER
AGAIN, BECAUSE WE'VE DONE THAT
IN THIS COMMITTEE.
WE'VE DONE THAT IN SPADES AT THE
COMMITTEE LEVEL, AT THE
SUBCOMMITTEE LEVEL.
SO, LET ME JUST HIT SOME
HIGHLIGHTS FOR YOU.
FIRST OF ALL, I'D LIKE AS A
CONTEXTUAL ISSUE FOR PEOPLE ON
THE COMMITTEE TO REMEMBER THAT
THIS IS NOT THE GUIDANCE
DOCUMENT.
THIS IS A RECOMMENDATION TO OHRP
THAT THEY THINK ABOUT THIS AS A
POSSIBILITY.
AND THERE WOULD HAVE TO BE A LOT
OF GESTATION AND CONSIDERATION
ON ANY RECOMMENDATION YOU MIGHT
MAKE AS A COMMITTEE BEFORE
ANYTHING WOULD ACTUALLY MAKE IT
INTO REGULATORY GUIDANCE SO
YOU'RE NOT VOTING ON REGULATORY
GUIDANCE BUT A REGULATION THERE
BE A DIFFERENT WAY OF THINKING
ABOUT THIS TO BE CONSIDERED.
SECOND THING, I WANT TO POINT
OUT AGAIN BOTH I AND THE
SUBCOMMITTEES ARE REALLY --
WE'RE INNOCENT BYSTANDERS IN ALL
OF THIS BECAUSE THIS WAS NOT --
THIS IDEA OF REVISITING THIS DID
NOT COME FROM THE SUBCOMMITTEES.
WE WERE ASKED BY OHRP TO TRY TO
LOOK AT THE EXISTING GUIDANCE
DOCUMENTS ON ENGAGEMENT RESEARCH
AND SEE IF WE COULD THINK ABOUT
IT IN A BLUE SKY WAY TO WHETHER
THERE MIGHT BE A DIFFERENT WAY
TO PROCEED.
THAT'S WHAT WE WERE ASKED TO DO.
THAT WAS THE CHALLENGE WE TOOK
UP ABOUT 18 MONTHS AGO WHEN WE
STARTED THE CONSIDERATION OF ALL
THIS.
IT WAS RELATED TO YOU LAST TIME
SUBCOMMITTEES AND YOU HAVE
CONSIDERED A LOT OF ALTERNATIVES
IN REGARD TO TO WHAT MIGHT BE
RECOMMENDED HERE.
THE LAST ROUND OF THIS, THE LAST
ITERATION OF ALL OF THIS
DISCUSSION, HAS REALLY BEEN AT
THAT SUBCOMMITTEE LEVEL, HAS
BEEN THAT WE CAN SAID DO WE JUST
SAY KEEP WHAT YOU'VE GOT AND
LET'S ADD ADDITIONAL SCENARIOS
THAT ARE COMMON SCENARIOS THAT
COME UP WITH COMMONALITY, SOME
FREQUENCY, JUST ASK THAT THOSE
ADDITIONAL SCENARIOS BE
ADDRESSED, AND LAYER ON A FOURTH
LEVEL OF GUIDANCE ON TOP OF THE
EXISTING THREE LEVELS OF
GIVEDDANCE ABOUT THIS.
OR DO WE DO SOMETHING BIGGER?
THE SUBCOMMITTEE AFTER TALKING
AND THINKING SAID WE REALLY WANT
TO DO SOMETHING THAT'S BIGGER
THAN THAT.
LET'S GO BACK TO FIRST
PRINCIPLES AND COME UP WITH
SOMETHING THAT WOULD DISTILL
CONVERSATIONS INTO A MORE
COMPREHENSIVE RECOMMENDATION TO
SACHRP AND ULTIMATELY TO OHRP
THAT WOULD NOT JUST ADD ON
ADDITIONAL SCENARIOS AND LAYER
ON TOP OF WHAT WE THINK IS
ALREADY CONFUSING AND IN SOME
CASES INCONSISTENT GUIDANCE.
AND YOU HAVE A COPY OF THIS, IT
ARRIVED IN MY MAILBOX AT THE
SAME TIME IN JERRY'S MAILBOX AND
MAYBE A COUPLE OTHER PEOPLE,
JULIE, MAYBE iVar AT OHRP,
BUT THE COMMITTEE ON GOVERNMENT
RELATIONS, A POLICY ADVOCACY
GROUP, THAT IS BASED IN
WASHINGTON AND CONSISTS OF 200
MEMBERS BASICALLY THE LEADING
ERST AND ACADEMIC MEDICAL
CENTERS RESEARCH INTENSIVE, IF I
GET THIS WRONG, ONE OF YOU WHO
KNOWS BETTER THAN I CAN CORRECT
ME, BUT THERE'S A RESEARCH
COMMITTEE OF COVR, AND THAT
COMMITTEE TOOK THIS ISSUE UP OF
ENGAGEMENT MINDFUL OF THE LAST
SESSION WE HAD AT SACHRP ON THIS
ISSUE I THINK IN MARCH AND
WEIGHED IN WITH THEIR OWN
LETTER.
YOU HAVE A COPY OF THE LETTER,
BUT THE LETTER REITERATES MANY
OF THE CONCERNS THAT HAVE BEEN
EXPRESSED BY THE SUBCOMMITTEE
MEMBERS AND EXPRESSED TO YOU
GUYS ABOUT HOW CONFUSING
GUIDANCE IS AND HOW IT REALLY
TENDS NOT TO FIT THE SOMEWHAT
REVOLUTIONARY NATURE OF THE
DECENTRALIZATION OF CLINICAL
TRIALS AND EMERGENCE OF SINGLE
IRBs THAT THEN ARE FACED WITH
MAKING ALL SORTS OF JUDGMENTS
ABOUT ALL OF THE ENTITIES OVER
25 OR 50 SITES THAT MAY SO
CALLED ENGAGED IN RESEARCH, IN
QUOTES.
I COMMEND THAT LETTER TO YOUR
ATTENTION BECAUSE IT'S ON THE
TABLE OVER HERE FOR THOSE WHO
AREN'T PRESENT PHYSICALLY IT'S
POSTED ON THE WEB.
>> ON THE DOCKET.
>> AND THAT -- I WAS GLAD TO
RECEIVE IT, AN ORGANIZATION
COMPOSED OF MANY ENTITIES
RESEARCH INTENSIVE SEEM TO THINK
IN TERMS OF THE CURRENT LAY OF
THE LAND THAT SEEM TO FEEL
SIMILARLY TO THE WAY THAT THE
SUBCOMMITTEE MEMBERS HAVE FELT
ABOUT THE CURRENT GUIDANCE.
I SUPPOSE PEOPLE WITHIN OHRP
WERE QUESTIONING AS WELL, THAT'S
WHY THEY ASKED US AS A
SUBCOMMITTEE AND YOU AS A
COMMITTEE TO LOOK AT THIS.
SO WE WENT THROUGH A LOT OF
DIFFERENT, AGAIN, ITERATIONS OF
THINGS, AND WHAT WE CAME UP WITH
WAS BASICALLY A RECOMMENDATION
WHICH IS ENSHRINED IN THE
LENGTHY LETTER THAT I PUT
TOGETHER AND WAS LOOKED AT BY
THE SUBCOMMITTEE TRYING TO LAY
OUT THIS IN A LARGER CONCEPTUAL
CONTEXT, OF WHAT THE
RECOMMENDATION WE'RE MAKING TO
YOU AND RECOMMENDING YOU MAKE TO
OHRP, WHAT IT ACTUALLY -- WHAT
THE BACKGROUND IS AND WHAT IT
MEANS.
LET ME GO TO THE RECOMMENDATION
HERE.
AND I'LL GO BACK.
SO, THE STANDARD WE'RE PROPOSING
IS BASICALLY THAT IN DECIDING
WHO IS ENGAGED IN RESEARCH FOR
PURPOSES OF NEEDING TO HAVE AN
ACTIVE FEDERAL ASSURANCE WITH
OHRP MEANING IT'S A PIECE OF
PAPER BUT IT IS AN ASSURANCE
THAT SUBJECTS THE ORGANIZATION
CONDUCTING THE RESEARCH THAT'S
ENGAGED IN THE RESEARCH TO THE
JURISDICTION OF OHRP AND ALSO
REQUIRES THAT THE ENTITY ENGAGED
IN RESEARCH HAVE ALL OF THE
POLICIES AND PROCEDURES IN ORDER
TO IMPLEMENT THE PROTECTIONS OF
THE COMMON RULE INCLUDING AN IRB
EITHER A LOCAL IRB OR IRB OF
RECORD THAT WOULD BE AN IRB BY
THE REVIEW PROCESS, RECOMMENDING
THAT THE DEFINITION BE REFINED
TO THE FOLLOWING.
PARTY IS ENGAGED IN RESEARCH IF
IT, IN GENERAL ENTITIES HERE, OR
ITS EMPLOYEES, STAFF OR AGENTS,
HAS A KEY ROLE IN DESIGNING
RESEARCH, CONDUCTING RESEARCH,
ANALYZING AND INTERPRETING THE
RESULTS, OR GAINING INFORMED
CONSENT FROM HUMAN SUBJECTS.
THIS IS AN ATTEMPT TO FOCUS THE
ENGAGED IN RESEARCH CONCEPT ON
THOSE WHO ARE MOST DEEPLY
INVOLVED IN THE RESEARCH AND WHO
HAVE CONTROL THE ESSENTIAL
ASPECTS OF THE RESEARCH, THE
RESEARCH DESIGN, RESEARCH
ANALYSIS, AND CONDUCT OF THE
RESEARCH.
SO THAT IS THE BOTTOM LINE
RECOMMENDATION AS TO HOW A NEW
STANDARD THAT MIGHT BE
ARTICULATED.
NOW, I WANT TO GIVE YOU A LITTLE
BIT OF BACKGROUND JUST IN THE --
AND THIS IS PUT INTO THE PROSE
DOCUMENT YOU HAVE.
ONE OF THE SOURCES OF THIS
RECOMMENDATION, CONCEPTUAL
SOURCES, THE COMMITTEE, THE
SUBCOMMITTEES HAVE LOOKED AT THE
OTHER WAYS IN WHICH FEDERAL
INSTITUTIONS AND OTHER KINDS OF
ORGANIZATIONS APPROACH HOW THEY
APPLY THEIR STANDARDS FOR
PROTECTING HUMAN SUBJECTS AND
FOR BEING RESPONSIBLE IN THE
CONDUCT OF RESEARCH.
AND SO WE LOOKED, WE TALKED
ABOUT THIS I THINK AT THE
MEETING, THE FDA IN THE WAY IT
ORGANIZES ENFORCEMENT OVER
CLINICAL TRIALS THAT ARE UNDER
THE FDA JURISDICTION, MANY OF
WHICH ACTUALLY CAN ALSO FALL
UNDER AT THE SAME TIME IN A VENN
DIAGRAM WAY UNDER THE COMMON
RULE IS THAT FDA DOES NOT LOOK
AT EVERY VENDOR THAT MAY BE
COLLECTING INFORMATION IN THE
COURSE OF A RESEARCH, THE FDA
FOCUSES ON THE INVESTIGATOR AND
THE CO-INVESTIGATORS WHO HAVE TO
SIGN WHAT'S CALLED A FORM 1572,
IN WHICH THEY TAKE
RESPONSIBILITY FOR THE CONDUCT
OF THE STUDY INCLUDING
RESPONSIBILITY FOR THE
ACTIVITIES OF TEAM MEMBERS IN
THE INSTITUTION AS WELL AS THE
VENDORS AND CENTRAL LABS AND
OTHERS THAT ARE LISTED ON THE
1572, BUT THEY DON'T HAVE TO
SIGN THEIR OWN 1572.
THE IDEA FROM FDA'S POINT OF
VIEW BEING THE INVESTIGATOR IS
THE PRIMARY AND APPROPRIATE
PRESSURE POINT FOR AN ENTITY
THAT SHOULD BE RESPONSIBLE FOR
THE RESEARCH SINCE HE OR SHE IS
THE ONE THAT ULTIMATELY IS
THROUGH THEIR INSTITUTION
CONTROLLING THE ACTIVITIES OF
ALL OF THESE OTHER PARTIES TO
THE RESEARCH.
THIS IS THE WAY THAT -- OH,
THANK YOU.
I DON'T MIND BEING DAVID BORASKY
FOR A DAY.
THIS IS THE WAY FDA DOES IT.
THERE DON'T APPEAR TO BE
TERRIBLE EFFECTS, THE WORLD HAS
NOT GONE CRAZY IN CLINICAL
TRIALS BECAUSE THE FDA DOESN'T
REGULATE VENDORS DIRECTLY.
IT SEEMS TO HAVE WORKED OUT FOR
FDA WELL.
SKIP FROM THE FDA COULD, FOR
EXAMPLE, COMMENT ON THIS IN THE
DISCUSSION IF HE WANTS.
THAT'S ONE REGULATORY MODEL WITH
WHICH THE RECOMMENDATION WE'RE
MAKING TO YOU WOULD BE
CONSISTENT.
ANOTHER THING WHICH IS NOT
REALLY -- IT'S NOT DIRECTLY
APPLICABLE BUT IT'S IMPORTANT IS
THE STANDARDS THAT THE
INTERNATIONAL COMMITTEE OF
MEDICAL JOURNAL EDITORS HAVE FOR
WHO IS ALLOWED TO BE AN AUTHOR
ON A PUBLICATION.
REMEMBER, A PUBLICATION,
RESEARCH PUBLICATION, IS AN
ATTEMPT BY A GROUP OF PEOPLE TO
OFFER GENERALIZABLE KNOWLEDGE TO
THE LAY PUBLIC AND TO THE
LEARNED PUBLIC ABOUT A SET OF
FINDINGS, DATA, THEIR ANALYSIS
AND THEIR FINDINGS AND WHAT THEY
THINK WOULD BE -- COULD BE
DISTILLED FROM THE WORK THEY
HAVE DONE AND NOT EVERYBODY
UNDER THESE STANDARDS IS ALLOWED
TO BE AN AUTHOR BECAUSE THEY ARE
NOT REGARDED HAVING SUFFICIENT
CONTROL OF AND PARTICIPATION IN
THE RESEARCH.
INSTEAD, ICMGE AFTER A SERIES OF
FRANKLY ABUSES WE DON'T HAVE TO
TALK ABOUT HERE ADDING LOTS OF
PEOPLE AS AUTHORS WHO HAD VERY
LITTLE TO DO WITH THE STUDY
OTHER THAN PERHAPS HAVING HELPED
FUND A STUDY OR HAVING A GRANT
OR REFERRING SOMEBODY TO THE
STUDY OR BEING A FRIEND OF THE
SENIOR AUTHOR OR FIRST AUTHOR, A
SERIES OF ABUSES LIKE THAT, THE
ALLOCATION OF BOTH CREDIT AND
RESPONSIBILITY FOR THE RESEARCH
THAT'S BEEN PUBLISHED TO A SET
OF PEOPLE WHO ESSENTIALLY ARE
THOSE WHO MAKES SUBSTANTIAL
CONTRIBUTIONS TO THE CONCEPTION
AND DESIGN OF THE WORK,
ACQUISITION, ANALYSIS AND
INTERPRETATION OF DATA, AND
DRAFT THE WORK OR REVISE
CRITICALLY FOR INTELLECTUAL
CONTENT AND HAVE FINAL APPROVAL
OVER THE FORM OF PUBLICATION.
AND IT'S THOUGHT IF YOU SIGN UP
AS AN AUTHOR, THAT, YES, YOU GET
THE CREDIT WHICH GOES ON YOUR
ACADEMIC CV, BUT YOU ALSO ARE
TAKING ON THE RESPONSIBILITY FOR
THE ACCURACY OF THAT WHICH HAS
BEEN PUBLISHED UNDER YOUR NAME.
THIS IS HOW THE -- ICMJE IS
FOCUSING ON THOSE WITH THE MOST
INPUT AND CONTROL.
AND THERE'S THE OTHER BACKGROUND
WHICH IS ACTUALLY QUITE
OPERATIVE IN REGARD TO THE
ENGAGED IN RESEARCH SCENARIO
THAT HOW DO WE -- REMEMBER THAT
ENGAGED IN RESEARCH IS A
SUBPOINT UNDER THOSE ENTITIES
THAT ARE RECEIVING FEDERAL
SUPPORT, FEDERAL MONETARY
SUPPORT FOR THEIR RESEARCH.
THERE'S NOT FEDERAL MONETARY
SUPPORT FOR THE RESEARCH, OHRP
DOESN'T GET INVOLVED AND THERE'S
NO FWA.
ONLY IF THERE'S SUPPORT WHICH
WE'LL TALK ABOUT TOMORROW WITH
DAVID FORSTER DOES THE
INSTITUTION THEN FALL UNDER
POTENTIAL OHRP JURISDICTION.
AND BUT IT'S NOT ALL ENTITIES
THAT ARE RECEIVING FEDERAL FUNDS
BUT ULTIMATELY ARE RESPONSIBLE
FOR THE EXPENDITURE OF FEDERAL
FUNDS.
INSTEAD, THE FUNDING AGENCIES
LIKE NIH AND DoD AND DOE AND
NSF FOCUS ON INSTITUTIONS WITH
SIGNIFICANT INTELLECTUAL INPUT
INTO AND CONTROL OVER THE DESIGN
AND CONDUCT AND REPORTING OUT OF
STUDIES.
AND IN THE VARIOUS GUIDANCE
DOCUMENTS REGARD TO WHO IS
RESPONSIBLE DIRECTLY TO THE
FUNDING -- FEDERAL FUNDING
AGENCY FOR THE EXPENDITURE OF
FUNDS AND CONDUCT OF WHAT THEY
DO UNDER USING FEDERAL MONEY, IT
DOESN'T REST DIRECTLY ON THE
VENDORS.
IT RESTS ON THE AWARDEE WHO HAS
A P.I. AND THE SUB-AWARDEES
WOULD OF WHO HAVE THEIR OWN
P.I.s, THAT'S WHERE THE
RESPONSIBILITY LIES.
THERE ARE GUIDANCE DOCUMENTS AND
TERMS AND CONDITIONS OF GRANT
AWARDS THAT PLACE ONTO THE
AWARDEES AND SUB-AWARDEES THE
REQUIREMENT THAT THEY BE -- THAT
THEY EXERCISE DILIGENCE IN
SELECTING VENDORS AND THEY MAKE
SURE THE VENDORS ARE SPENDING
MONEY APPROPRIATELY AND
PERFORMING SERVICES THEY
PROMISED TO SERVE UNDER THE
SCOPE OF WORK OF THE VENDOR
AGREEMENT.
BUT THE DIRECTLY ANSWERABLE
PARTIES ARE NOT THE VENDORS THAT
ARE PROVIDING SERVICES TO
IMPLEMENT THE TRIAL, EVEN WHEN
THEY ARE -- OF THE STUDY, EVEN
WHEN LAYING HANDS ON PATIENTS,
THE ENTITY RESPONSIBLE DIRECTLY
TO THE FEDERAL GOVERNMENT ARE
THE AWARDEES AND SUB-AWARDEES
EACH OF WHICH HAS A PRINCIPAL
INVESTIGATOR AND OTHER NAMED
CO-INVESTIGATORS, KEY PERSONNEL
WHO ARE ENGAGED, WHO ARE ENGAGED
FOR THESE PURPOSES, IN THE
CONTROL AND CONDUCT OF THE
STUDY.
THE FEDERAL FUNDING AGENCIES
DOES NOT SEEK BECAUSE THEY DON'T
THINK THEY NEED TO SEEK TO
FULFILL THEIR MANDATE THEY HAVE
PLENARY JURISDICTION, FOCUS ON
THOSE WHO APPLY FOR THE MONEY
AND CONTROL THE MONEY AND THE
IMPLEMENTATION OF THE RESEARCH
PLAN.
SO, IT WAS THESE KINDS OF
FRAMEWORKS THAT WE HAD IN MIND
WHEN WE WROTE THIS REFINEMENT OF
THE ENGAGED IN RESEARCH
SCENARIO, FOR THE PURPOSE OF
ENGAGED IN RESEARCH.
NOW, ANOTHER THING I WANT TO
POINT OUT TO YOU IS REALLY THIS.
AND THAT IS THAT WE HAVE THREE
DIFFERENT OPERATIVE GUIDANCE
DOCUMENTS RIGHT NOW FROM OHRP,
2008, 2009, 2011, ON
INTERPRETING THE ENGAGED IN
RESEARCH.
NONE OF THAT STUFF IS MANDATED
BY REGULATION.
NONE OF IT IS REQUIRED, NONE OF
THE CONTENT OF THOSE GUIDANCE
DOCUMENTS IS REQUIRED BY
REGULATION.
THERE'S ONLY ONE THANK THAT IS
ACTUALLY IN REGULATION, AND THAT
IS IN THE COMMON RULE ITSELF IT
SAYS EACH INSTITUTION ENGAGED IN
RESEARCH THAT IS COVERED BY THIS
POLICY EXCEPT RESEARCH ELIGIBLE
FOR EXEMPTION AND CONDUCTED OR
SUPPORTED BY FEDERAL DEPARTMENT
OR AGENCY, AND TOMORROW WE'LL
GET TO FEDERAL SUPPORT BECAUSE
WE HAVE RECOMMENDATIONS DAVID
FORSTER WILL GIVE YOU, PROVIDE
WRITTEN ASSURANCE THAT ALMOST
COMPLY WITH THE REQUIREMENTS
WHICH WOULD BE AN FWA.
IT'S THEN THAT'S THE -- THERE'S
NO OTHER REQUIREMENT IN THE
REGULATION FOR WHAT IS ENGAGED
IN RESEARCH, JUST THIS TERM
THAT'S ELABORATED BY OHRP IN
THESE ADDITIONAL GUIDANCE
DOCUMENTS.
IF YOU LOOK AT -- THAT'S ALL
THERE IS THAT'S REQUIRED, RIGHT?
EVERYTHING ELSE IS
INTERPRETATION.
IF YOU LOOK AT THE 2008 BASELINE
GUIDANCE OHRP OPINED THAT THIS
IS THE WAY ONE DECIDES WHO IS
ENGAGED IN RESEARCH, WHO IS NOT.
IN GENERAL WHEN DATA IS OBTAINED
ABOUT SUBJECTS THROUGH
INTERVENTION, WHO OBTAINED
IDENTIFIABLE INFORMATION ABOUT
SUBJECTS OR WHO OBTAIN INFORMED
CONSENT, SO THAT'S THE
PRIMARY -- THAT'S THE FIRST
LEVEL OF REFINEMENT OF
INTERPRETATION OF WHAT IS
ENGAGED IN RESEARCH.
SO YOU HAVE THAT.
THEN THERE'S A SECOND LAYER OF
INTERPRETATION WHICH IS THAT
THIS THING IN GENERAL, THESE
LINES RIGHT HERE, STARTING IN
GENERAL, ENDING WITH INFORMED
CONSENT OF THE HUMAN SUBJECTS
ARE THEN INTERPRETED IN THE
FOLLOWING WAY, IN THE SAME
DOCUMENT.
INSTITUTIONS WHOSE EMPLOYEES OR
AGENTS RECEIVE AN AWARD EVEN IF
ALL ACTIVITIES ARE CONDUCTED BY
ANOTHER INSTITUTION.
INSTITUTIONS THAT INTERVENE FOR
RESEARCH PURPOSES BY PERFORMING
INVASIVE PROCEDURES,
INSTITUTIONS THAT INTERVENE FOR
RESEARCH PURPOSES BY
MANIPULATING THE ENVIRONMENT.
INSTITUTIONS THAT OBTAIN
INFORMED CONSENT, INSTITUTIONS
THAT OBTAIN IDENTIFIABLE PRIVATE
INFORMATION FROM ANY SOURCE FOR
THE RESEARCH.
NOW, SO, THE REASON I'M GIVING
YOU THIS IS BECAUSE THIS IS PART
OF THE COMPLEXITY THAT WE AND BY
THE WAY THE KROGER LETTER IS
REACTING TO WHICH IS IT'S NOT
JUST A SIMPLE SET OF STANDARDS.
IT'S A SET OF STANDARDS, SECOND
SET OF STANDARDS, AND IN THE
2009 AND 2011 GUIDANCE THERE ARE
EXAMPLES, I WON'T GO THROUGH
THIS BECAUSE WE'VE GONE THROUGH
IN MARCH A LOT OF THIS ANALYSIS,
BUT MANY OF THOSE EXAMPLES OR
SOME EXAMPLES ONE COULD ARGUE
ARE NOT ENTIRELY CONSISTENT WITH
THE STANDARDS ARTICULATED IN THE
2008 GUIDANCE, EITHER THE FIRST
LEVEL GUIDANCE OR SECOND LEVEL
GUIDANCE, AND I'M CALLING THIS
THE FIRST LEVEL GUIDANCE AND
CALLING THIS SECOND LEVEL
GUIDANCE.
AND I CAN -- I GUESS WHAT I'LL
DO IS FOR A MOMENT I'LL JUST
WALK YOU THROUGH A COUPLE OF
THINGS HERE.
YOU SEE THIS IS THE FIRST LEVEL
OF GUIDANCE, IN GENERAL.
AND INSTITUTIONS WHOSE EMPLOYEES
OR AGENTS -- THIS IS THE SECOND
LEVEL -- RECEIVING AWARD EVEN IF
ALL ACTIVITIES ARE CONDUCTED BY
ANOTHER INSTITUTION, SO A
FLOW-THROUGH ENTITY THAT HAS NO
INVOLVEMENT IN RESEARCH IS THAT
ENTITY OBTAINING DATA ABOUT
SUBJECTS?
NO.
IS IT OBTAINING IDENTIFIABLE
PRIVATE INFORMATION?
NO.
IS IT OBTAINING INFORMED
CONSENT?
NO.
MY POINT HERE, I COULD GO
THROUGH ALL OF THESE THINGS, IS
THAT THE SECOND LEVEL GUIDANCE
IS NOT REALLY FULLY CONSISTENT
WITH THE FIRST LEVEL GUIDANCE.
I COULD GO THROUGH THE OTHER
EXAMPLES, THIS IS THE PROBLEM TO
WHICH WE'RE REACTING.
AS KROGER SAID, OTHERS IN THE
SUBCOMMITTEES HAVE SAID TO ONE
ANOTHER, AND ARE SAYING TO YOU
IN THE RECOMMENDATION, IS THAT
THE REGULATED COMMUNITY IS
CONFUSED BY THESE LEVELS OF
GUIDANCE.
THERE'S ONE PHRASE WHICH HAS
FIRST LEVEL GUIDANCE, AND SECOND
LEVEL GUIDANCE, AND THEN TWO
ADDITIONAL GUIDANCES THAT GIVE
EXAMPLES OF WHAT'S IN AND WHAT'S
OUT.
AND THOSE, UNLESS YOU WANT ME TO
I WON'T GO THROUGH ALL OF THAT
AT ALL BUT SUFFICE IT TO SAY
THAT IT'S NOT -- THIS IS NOT
JUST MY OPINION.
IT'S THE OPINION OF A BROAD
SWATH OF THE REGULATED
COMMUNITY.
AND SO THIS IS NOT -- WE GET
THEN TO THE RECOMMENDATION WHICH
IS AS I SAID BEFORE THAT WE
BASICALLY -- RECOMMENDATION IS
DITCH ALL THAT STUFF YOU'VE GOT
AND CONCENTRATE ENGAGED IN
RESEARCH, REQUIREMENT TO HAVE
FWA AND REQUIREMENT TO BE
RESPONSIBLE FOR THE CONDUCT OF
THE RESEARCH, PUT THAT ON THE
PLACE WHERE IT BELONGS AND SO
THAT YOU HAVE SMART REGULATION,
NOT JUST MORE REGULATION, AND
THE SMART REGULATION IS FOCUSED
ON THOSE WHO ARE MOST DEEPLY
INVOLVED IN PARTICIPATION,
CONTROL, AND THEREFORE WHOSE
INVOLVEMENT IS ACTUALLY IN
GENERAL THE MUCH HIGHER THAN THE
VENDORS AND BEST ABLE TO
PARTICIPATE AND PREVENT RISK BY
OTHERS PERFORMING SERVICES IN
THE CONTEXT OF THE RESEARCH.
SO, A COUPLE OTHER THINGS ABOUT
THIS, ABOUT THIS RECOMMENDATION.
ONE IS THAT THE -- AS WITH THE
CURRENT GUIDANCE, THIS WOULD BE
APPLIED BY INSTITUTIONS THAT ARE
CONSIDERING HAVING THEIR STAFF
OR AGENTS OR FACULTY DO
RESEARCH, IT WOULD BE CONSIDERED
BY IRBs WHEN IT ASKS WHETHER
THE ENTITIES THAT ARE APPLYING
FOR THE RESEARCH AND THAT ARE
INVOLVED IN THE RESEARCH HAVE
FWAs OR SHOULD AND CONSIDERED
BY INVESTIGATOR PLANNING WHO
WILL HELP THEM DO THE RESEARCH.
THE GUIDANCE THAT THE
RECOMMENDATION TO OHRP IS THAT
THE -- THAT REASONABLE
DETERMINATIONS BY AN INSTITUTION
AND AN IRB AND AN INVESTIGATOR
AS TO WHO IS ENGAGED IN RESEARCH
AND WHO IS NOT UNDER THIS
STANDARD WOULD BE GIVEN A
PRESUMPTION VALIDITY AS LONG AS
THEY ARE REASONABLE AND
RATIONALEE FOR THE DECISION
MAKING HAS DOCUMENTED.
WE THINK -- THIS WILL NOT BE A
PANACEA, IF ADOPTED.
THERE WOULD NEED TO BE GUIDANCE
EXAMPLES CULLED FROM, WE HOPE,
THIS IS WHAT THE RECOMMENDATION
IS, OHRP SOLICIT COMMENT FROM
REGULATED COMMUNITY AS TO WHAT
SCENARIOS NEED TO BE ADDRESSED
AND FAQs ARE IN A GUIDANCE
DOCUMENT.
AND SO IT'S NOT THE -- IF OHRP
WERE TOMORROW TO ADOPT -- IF YOU
WERE TO APPROVE AND RECOMMEND
IT, OHRP WERE TO ADOPT, THAT'S
NOT THE END OF THE STORY.
THERE'S A LOT MORE WORK THAT
NEEDS TO BE DONE.
LET ME TELL YOU, THERE WILL BE
DIFFICULTIES APPLYING THE NEW
DEFINITION.
THE POINT IS WE THINK THAT THERE
WILL BE FEWER DIFFICULTIES AND
MORE STRAIGHTFORWARD AND
RATIONAL APPROACH TO DETERMINING
WHO IS ENGAGED IN RESEARCH UNDER
RECOMMENDED APPROACH AS OPPOSED
TO THE CURRENT QUITE CONFUSING
APPROACH.
IT'S NOT THE END OF THE STORY.
I'M NOT SAYING -- DON'T SAY THAT
WE SAY THERE ARE NO PROBLEMS
WITH THIS APPROACH.
THERE ARE PROBLEMS WITH THIS
APPROACH IN TERMS OF APPLYING IT
IN LOTS OF INDIVIDUAL CASES BUT
WE THINK THAT IT IS EASIER UNDER
THIS APPROACH TO APPLY IT AND TO
APPLY IT IN A WAY THAT IS
CONSISTENT ACROSS EXAMPLES AND
SCENARIOS, AND WE THINK THIS
COULD BE DONE IN A CONSTRUCTIVE
WAY THROUGH ENGAGEMENT WITH THE
REGULATED COMMUNITY.
SO, IN ANY CASE, I THINK THAT
THAT IS AS MUCH AS I WANTED
TO -- OH, ONE OTHER THING.
ONE OTHER POINT THAT IS WORTH
TALKING ABOUT IN THIS INITIAL
PRESENTATION.
AND THAT IS THAT THE -- THERE
WAS A LOT OF DISCUSSION AS TO
WHETHER THE SIMPLE ACT OF
OBTAINING INFORMED CONSENT IF AN
ENTITY IS NOT OTHERWISE INVOLVED
IN THE RESEARCH SHOULD MAKE THAT
ENTITY ENGAGED IN THE RESEARCH
UNDER EXISTING GUIDANCE IT IS.
THERE ARE A NUMBER OF PEOPLE AT
THE SUBCOMMITTEES AND I THINK
PROBABLY AT KROGER WHO THINK
THAT IF ONE'S ONLY INVOLVEMENT
IS OBTAINING INFORMED CONSENT
THAT THAT SHOULD NOT MAKE ONE
THE ENTITY BE ENGAGED IN
RESEARCH BUT WE REACHED A
DIFFERENT CONCLUSION IN THE
RECOMMENDATION.
WE THINK OBTAINING INFORMED
CONSENT SHOULD BE ENGAGED IN
RESEARCH BUT POSSIBLE IN LIMITED
CIRCUMSTANCES FOR AN IRB OR
INSTITUTION TO DETERMINE THE
ENTITY THAT IS ONLY OBTAINING
INFORMED CONSENT COULD BE
REGARDED AS NOT ENGAGED IN
RESEARCH IN OBTAINING LOW RISK
STUDIES AND OBTAINING CONSENT
PARTICIPANTS ARE OFFERED
OPPORTUNITIES TO ENGAGE IN
DISCUSSION WAS PRIMARY RESEARCH
TEAM FACILITATED BY ENTITY
SEEKING TO OBTAIN CONSENT.
WE'RE TALKING ABOUT LOW RISK,
NON-INTERVENTIONAL STUDIES, THE
PRIMARY DRIVER OF THIS IS THE
SCENARIO WHICH IS GIVEN TO YOU
IN THE MATERIALS OF A CANCER
HOSPITAL IN MADRID THAT IS
CONSENTING FOLKS, OBTAINING
CONSENT FROM FOLKS TO ENROLL IN
A NATURAL HISTORY STUDY THAT IS
FUNDED BY THE NIH WHICH IS
SOLELY STANDARD OF CARE, THE
ONLY PARTICIPATION OF THE
INDIVIDUAL WOULD BE THAT THEIR
DATA LONGITUDINALLY WHEN GIVEN
STANDARD OF CARE IN MADRID WOULD
BE COLLECTED AND SENT UNDER
AAPPROPRIATE CONDITIONS IN THE
U.S., THE HOSPITAL IN MADRID
SHOULD NOT BE SUBJECT --
REGARDED AS ENGAGED IN RESEARCH
WHEN ALL IT'S DOING IS
SOLICITING CONSENT, OBTAINING
CONSENT, IN THE LOW RISK STUDY
PRIMARY RISK IS DATA COULD BE
COMPROMISED AND SO ANYWAY THAT
IS THE PRESUMPTION ACCORDING TO
THIS RECOMMENDED RECOMMENDATION
TO YOU IS THAT OBTAINING
INFORMED CONSENT WOULD MAKE AN
ENTITY ENGAGED IN RESEARCH
EXCEPT IN A NARROW CIRCUMSTANCE,
THAT WOULD BE ALLOWABLE BUT NOT
REQUIRED THAT AN IRB OR
INSTITUTION WOULD REACH THE
DETERMINATION THAT ENTITY IN
MADRID IS NOT ENGAGED IN THE
RESEARCH SO IT WOULD BE A WAY
OUT BUT NOT DISPOSITIVE.
OKAY?
I'M GOING TO STOP THERE.
THAT IS THE -- I COULD GO ON FOR
A LONG TIME.
THERE'S A DOCUMENT THAT HAS BEEN
THROUGH A LOT OF REVIEW BUT I
HOPE YOU'VE HAD A CHANCE TO READ
BUT I'LL STOP THERE.
>> QUESTION.
>> YES?
>> I JUST HAVE A QUESTION.
I LIKE THE DIRECTION YOU'RE
GOING AND I LIKE THE DEFINITION.
OBVIOUSLY AS YOU POINT OUT
THERE'S A LOT OF INTERPRETIVE
ISSUES, KEY ROLE, ET CETERA,
THAT'S STILL GOING TO REMAIN BUT
I'M CURIOUS ABOUT WHAT THE
PROCESS IS.
LET'S IMAGINE THE COMMITTEE SAYS
THIS LOOKS LIKE A GOOD
DIRECTION.
WHAT THEN?
ARE WE GOING TO, AS THE
SUBCOMMITTEE, THEN COME BACK
WITH FLESHING THIS OUT, WITH
EXAMPLES?
WOULD IT DISAPPEAR BEHIND THE
CLOSED DOORS OF OHRP WHO THEN
COME OUT WITH DRAFT GUIDANCE ON
THEIR OWN?
WHAT DO YOU IMAGINE THAT PROCESS
TO LOOK IKE OR IF WE ENDORSE
THAT WOULD IT REQUIRE OHRP TO
SAY BACK TO THE SUBCOMMITTEE,
DEVELOP EXAMPLES TO FLESH OUT
WHAT THIS REALLY LOOKS LIKE?
SO IN YOUR IDEAL WORLD WHAT
WOULD YOU IMAGINE THAT TO LOOK
LIKE?
>> I THINK IN AN IDEAL WORLD,
THE WAY IT WOULD WORK IS THAT WE
AS AN ADVISORY -- AS AN ADVISORY
COMMITTEE TO YOU, YOU AS
ADVISORY SUBCOMMITTEE OR
COMMITTEE TO OHRP WE ESSENTIALLY
DON'T SET OUR OWN AGENDAS, WE
RESPOND TO QUESTIONS THEY RAISE.
OHRP WOULD LOOK AT IT AND THEY
WOULD PRESUMABLY SAY WE LIKE
THIS, WE DON'T LIKE THIS, IF WE
THINK THIS IS A POTENTIALLY
POSITIVE DIRECTION, WE HAVE
ADDITIONAL QUESTIONS FOR THE
COMMITTEE AND THE SUBCOMMITTEES
AS TO HOW THIS WOULD BE
INTERPRETED IN THE FOLLOWING
WAYS SO PLEASE GIVE US
ADDITIONAL GUIDANCE ON HOW YOU
THINK THIS WOULD APPLY IN THESE
SCENARIOS.
IF THEY THINK IT'S TRASH THEY
WOULDN'T ASK US THAT.
AND THAT'S OKAY.
BUT IT WOULD BE UP TO THEM TO
SEE WHETHER THEY THINK THIS IS A
FRUITFUL AVENUE OR NOT.
IF THEY WANTED OUR OPINION ABOUT
WAYS IN WHICH WE COULD MORE
PARTICULARIZE THE APPLICATION
AND WE WOULD DO OUR WORK AND
WOULD COME BACK TO YOU, YOU
WOULD LOOK AT THE EXAMPLES AND
YOU WOULD GO FROM THERE.
>> LOIS?
>> HI, I REALIZE YOU JUST
REFERRED TO CASE EXAMPLE 3 AND
EXHIBIT A.
I DON'T KNOW IF I'VE SEEN THAT
EXHIBIT A SLIDES.
>> GO OUT ON A LIMB, MAKE A
MOTION WE ENDORSE THIS LET'S
CALL IT DIRECTION AND MY HOPE
OHRP WOULD SEE THIS AS A
PRODUCTIVE STEP AND THEN WOULD
ASK FOR THE SUBCOMMITTEE TO THEN
DO FURTHER WORK AND PRECISELY
APPLYING THIS DEFINITION IN SOME
PROBLEMATIC CASES, TO SAY HOW IT
WOULD WORK BECAUSE, YOU KNOW,
KEY ROLE IN CONDUCTING, ONE
COULD INTERPRET THAT TO MEAN IT
WOULD INCLUDE LET'S SAY A CRO
VENDOR OR NOT, STILL BE SOME
WORK.
I GUESS I WOULD MOVE THAT WE
ACCEPT THIS DOCUMENT,
UNDERSTANDING THE NATURE OF THE
DOCUMENT AND THAT IT'S REALLY A
WORK IN PROGRESS AND FORWARD IT
TO OHRP WITH A RECOMMENDATION
THAT FURTHER WORK BE DONE IN
THIS DIRECTION, I GUESS THAT
WOULD BE MY MOTION.
>> GO AHEAD.
>> WE HAVE A MOTION.
DO WE HAVE A SECOND?
>> I WAS GOING TO SECOND WITH
THE UNDERSTANDING THAT WE'RE
GOING TO BE ABLE TO FURTHER
REFINE AND GET INTO THE DETAILS.
>> OKAY.
>> OF THE DOCUMENT.
AS LONG AS THAT'S THE CASE, I
WOULD SECOND.
>> OKAY.
ANY FURTHER DISCUSSION,
COMMENTS, CONCERNS?
YES, GO AHEAD, LOIS.
>> I WOULD JUST LIKE TO KNOW,
I'M ABOUT READY TO GO WITH IT
TOO.
THERE WERE A COUPLE TYPOS BUT
WAS THERE A REASON TO USE THE
TERM LOW RISK INSTEAD OF MINIMAL
RISK?
>> WE COULD USE LOW RISK INSTEAD
OF MINIMAL.
>> WE HAVE AN IDEA, AN
UNDERSTANDING OF MINIMAL RISK,
AND NO RISK, I WONDERED IF THAT
WAS DELIBERATE OR --
>> IT WASN'T.
THE ONLY DELIBERATENESS OF THE
USE OF THAT TERM WAS JUST THAT I
WAS TRYING TO CONCEPTUALIZE NOT
IN EXISTING REGULATORY FRAMEWORK
BUT IN A MORE GENERAL WAY.
>> IT'S GOING TO EVENTUALLY BE
IN -- RIGHT.
>> IT WILL.
AND I THINK THAT PARTICULAR
POINT COULD BE PROPERTY --
BROUGHT UP HOW DOES LOW RISK
CORRELATE TO MINIMAL RISK.
SKIP?
>> JUST BEING AWARE OF THE
DISCUSSION, MINIMAL RISK IN
PEDIATRIC CONTEXT, I'M NOT SURE
IT SOLVES THE PROBLEM.
ICH e-6, IT'S NOT DEFINED
ACROSS MANY STAKEHOLDERS, WE
WOULD GET INTO THAT BUT IT'S NOT
STRAIGHTFORWARD TO USE LOW RISK
I THINK.
>> GO AHEAD, KEVIN.
>> ONE SPECIFIC THING, FIRST OF
ALL, IT WAS SUCH A WELL DRAFT,
OUTSTANDING, THANKS TO ALL THE
BACK AND FORTH IT TOOK TO GET
HERE.
RIGHT UNDER THE FIRST MENTION OF
THE STANDARD, WHICH I DON'T SEE
THE PAGE NUMBERS HERE.
>> FIRST PAGE, YEAH, IT WOULD BE
THE FIRST PAGE.
>> YEAH, THERE'S ABOUT A
SIX-LINE SENTENCE THAT BEGINS IN
SACHRP'S VIEW, THAT I DON'T
UNDERSTAND THAT SENTENCE.
IT SEEMS LIKE THERE'S A
PREDICATE CLAUSE MISSING FROM
THE FIRST THREE LINES SOMEWHERE.
WE HAVE TO FIX IT NOW THAT --
STANDARD WOULD PLACE THE BURDEN
OF ENSURING RESEARCH SUPPORTED
BY FEDERAL FUNDING SOMETHING
RESTS ON THE ENTITIES AND
PERSONS.
I MAY HAVE MISREAD IT.
YEAH, PAGE 3.
>> IT'S THE LAST PARAGRAPH OF
THE -- WHAT'S REALLY THE
INTRODUCTORY SECTION.
>> AGAIN, WE DON'T NEED TO TAKE
UP DISCUSSION TIME BUT JUST LOOK
AT IT AGAIN.
IT SEEMS LIKE THERE'S SOMETHING
MISSING OR I NEED TO BE MORE
CAFFEINATED.
>> I CAN DIVIDE THAT INTO TWO
SENTENCES THAT WILL MAKE IT
CLEARER.
WHY DON'T I DO THAT?
>> AND THE OTHER, --
>> I'M NOT UNDERSTANDING ON THE
SCREEN WHY IT WAS RISKY.
>> YOU GUYS ARE NOT SEEING IT.
>> FEDERAL GOVERNMENT SHUTDOWN
WE DIDN'T KNOW ABOUT?
>> SHOULD I CONTINUE TO TALK OR
WAIT?
>> YOU'RE GOOD.
>> OH.
YOU KNOW, A LOT OF US DO
RESEARCH INCREASINGLY HAS
PATIENTS, PATIENT COMMUNITY,
COMMUNITY MEMBERS, INVOLVED IN
DIFFERENT WAYS, CONDUCT OF THE
RESEARCH.
AND IT'S IMPORTANT TO THEM TO BE
RECOGNIZED FOR THAT.
AND SO WHATEVER GUYEDANCE WERE
TO COME OUT IT MAY BE USEFUL
USEFUL TO HAVE OTHER
TERMINOLOGY, IT'S A TECHNICAL
MATTER ENGAGED IN THE RESEARCH,
JUST FOR COMMUNICATING I'M
CALLING THAT OUT THAT THOSE
LANGUAGE THINGS ARE IMPORTANT TO
PEOPLE AND THERE MAY BE AN
INADVERTENT MESSAGE THAT GOES
OUT, SO HEADING THAT OFF AT THE
PASS MIGHT BE A USEFUL THING TO
CONSIDER.
THOSE ARE THE COMMENTS I HAD..
>> LINDA AND WALTER?
>> HIS HAND WAS UP FIRST.
>> THANK YOU.
APPRECIATED THE CONTEXT, YOU
MADE IT CLEAR A CLEAR CASE FOR
THE NEED FOR A CLEAR DEFINITION
OF ENGAGING IN RESEARCH GIVEN
CONFLICTING GUIDANCES BETWEEN
2008 AND 2011.
THE ONLY AREA THAT I STUMBLED
OVER WAS INFORMED CONSENT ISSUE.
BUT I THINK YOU PROVIDED A GOOD
EXPLANATION FOR WHY THAT SHOULD
BE CAPTURED.
I'M SUPPORTIVE AND I THOUGHT
THAT SKIP DID A GOOD JOB WITH
RESPECT TO THE MOTION, FRAMING
IT IN A WAY THAT'S DIRECTIONAL
GUIDANCE TO THE SUBCOMMITTEE,
I'M FULLY SUPPORTIVE.
>> GO AHEAD, LINDA.
>> COMMENTS IN CONVERSATION, I'M
SORRY.
>> YOU'RE GOOD.
>> IN REGARD TO THE INFORMED
CONSENT SOMETIMES THAT ISSUE CAN
BECOME PROBLEMATIC, LOW RISK,
MINIMAL RISK, THIS IS A
DIRECTIONAL DOCUMENT, FURTHER
REFINE THAT, BUT THERE ARE WAYS
OF READYING IT SO IN ADDITION
TO, SAY, A SITUATION THAT'S
CLOSE CALL AND YOU'RE NOT SURE
AND IT'S IN THE MIDDLE, SO
THEREFORE THEY WOULD BE
CONSIDERED ENGAGED, THERE ARE
WAYS, OPERATIONALLY, TO ADDRESS
THAT.
SO, INTERNATIONAL CONTEXT WE
HAVE SITES YOU WOULD SIMPLY HAVE
MAYBE INVESTIGATORS THEN
VIRTUALLY CONSENT THOSE PEOPLE.
SO THERE ARE THINGS WE CAN MAYBE
ADD WHEN WE FURTHER REFINE THIS
TO GIVE SOME PRACTICAL EXAMPLES
OF HOW YOU CAN REMEDY FOR THOSE
PEOPLE STILL STRUGGLING WITH,
WELL, ARE WE ENGAGED, NOT
ENGAGED, CONCERNED ABOUT MAKING
A WRONG DECISION, THERE ARE WAYS
OF MANAGING THAT.
SOMETIMES HAVING THAT IN THERE
WOULD BE BENEFICIAL TO THE
RESEARCH COMMUNITY, SOMETIMES
IT'S HARD TO KNOW WHAT TO DO,
WHAT DO WE DO WITH THIS?
THAT'S MY ONLY COMMENT.
>> I COMPLETELY AGREE.
I ALMOST PUT THAT STUFF IN HERE.
>> OKAY.
>> THE IDEA OF HAVING A VIRTUAL
PRESENCE OF THE DIRECT PRIMARY
RESEARCH TEAM AS BEING A
SOLUTION.
WE CAN DEFINITELY PUT THAT IN.
>> IN FUTURE DOCUMENT.
>> EXACTLY.
>> WE GET INTO SOME OF THE --
HOPEFULLY GET INTO IF OHRP
THINKS IT'S WORTH PURSUING,
DEFINING WHAT SUPERVISION MEANS
IN THE NEW WORLD OF ZOOM CALLS,
DISTANCE, ET CETERA.
THE REAL WORLD EVEN ABSENT THAT,
THE MOST OF THE INFORMED CONSENT
IN STUDIES DONE IS BY THE
RESEARCH COORDINATOR, NOT THE
PRINCIPAL INVESTIGATOR BUT THE
PRINCIPAL INVESTIGATOR IS HELD
RESPONSIBLE IF THERE'S SOMETHING
WRONG WITH THE PROCESS.
DELINEATING RESPONSIBILITY, WHEN
CAN YOU DELEGATE AUTHORITY, BUT
YOU CAN'T DELEGATE YOUR
RESPONSIBILITY, ET CETERA, ALL
WOULD HAVE TO BE PULLED INTO
EXAMPLES AND CLARIFIED.
>> ANY OTHER COMMENTS?
>> CAN YOU HEAR US?
WE DON'T SEE YOU ALL ON THE
SCREEN.
>> THERE ARE I.T. PROBLEMS THAT
ARE BEING WORKED ON.
>> ARE THEY ABLE TO HEAR US?
>> THEY CAN HEAR US.
I CAN SEE THEIR FACES ON THE
SCREEN.
>> SO I'M ASSUMING THERE ARE NO
COMMENTS FROM THE THREE MEMBERS
WHO ARE ONLINE.
>> CONSUELO?
>> I HAVE COMMENTS.
>> CAN YOU HEAR US.
>> SOMEONE HAS A COMMENT.
>> CONSUELO, DO YOU HAVE A
COMMENT?
>> YES.
CAN YOU HEAR ME?
>> BARELY.
>> OKAY.
SO, I JUST WANT TO REITERATE THE
ISSUE ABOUT ENGAGEMENT, IT CAME
UP IN ONE OF THE EARLIER
READINGS HERE.
I THINK IT'S VERY IMPORTANT FOR
US TO DEFINE ENGAGEMENT CLEARLY,
ENGAGEMENT IS A SCIENCE, AND
THERE'S A WHOLE GROUP, A
COMMUNITY OF PEOPLE WHO SPEND
THEIR TIME FOCUSED ON ENGAGEMENT
SO WE WANT TO BE CLEAR THAT THE
LANGUAGE IS ABOUT ENGAGING VIA
SPECIFIC TECHNICAL DEFINITION,
JUST REALLY WANT TO REITERATE
THE NEED FOR THE RIGHT
MESSAGING, SO WE'RE NOT TAKING
STEPS BACKWARDS AS RELATES TO
COMMUNITY AND PARTICIPANT
ENGAGEMENT.
>> MARK, CAN YOU RESTATE THAT?
I'M SURE THE PUBLIC DIDN'T --
>> I THINK -- NOD IF I GET THIS
WRONG, SAYING THAT THERE ARE A
LOT OF PEOPLE TRYING TO APPLY
THIS DEFINITION AND THERE NEEDS
TO BE GREATER SPECIFICITY TO BE
MORE PREDICTABLE AND EASILY
APPLICABLE.
IS THAT ESSENTIALLY WHAT YOU
WERE SAYING OR NO?
NO?
>> NOT QUITE.
>> OH, OKAY.
>> MARK, IS YOUR MIC ON?
>> I DON'T KNOW.
MAYBE NOT.
>> WE HEAR HIM.
>> THERE'S NO --
>> I DON'T KNOW.
I DIDN'T DO ANYTHING BETWEEN
DAVID BORASKY AND THIS.
>> SPEAK ROBUSTLY.
>> OKAY.
SO, AM I HEARING -- ARE THESE
COMMENTS REQUIRING CHANGES TO
THIS DOCUMENT OR IS THIS JUST
COMMENT ABOUT MOVING FORWARD?
>> IT'S A COMMENT ABOUT MOVING
FORWARD AND NOT ABOUT THIS
DOCUMENT.
NOW THAT I UNDERSTAND, SHE WAS
MAKING A POINT SIMILAR TO THE
POINT KEVIN WEINFURT MADE
BEFORE.
>> CONSUELO ADDED THERE'S A
SCIENCE OF ENGAGEMENT TOO.
SO THAT'S ANOTHER -- IT'S A WORD
THAT IS OUT THERE USED IN A
DIFFERENT CONTEXT TOO.
>> WOULD ANYBODY ELSE LIKE TO GO
AHEAD?
>> WONDERING BEFORE WE ACTUALLY
VOTE IF WE CAN KNOW WHAT THE
MOTION IS BECAUSE IT SEEMED TO
HAVE --
>> DID YOU HAVE ANOTHER COMMENT?
OKAY, GREAT.
>> THIS IS BASED ON MY
UNDERSTANDING OF THE PROCESS.
SO, WHAT WE WOULD BE DOING IS --
THIS IS NOT A GUIDANCE DOCUMENT.
THIS IS BASICALLY A DIRECTIONAL
DOCUMENT THAT SAYS TO OHRP THAT
THIS GROUP, SACHRP, WOULD
RECOMMEND THIS DEFINITION WHICH
IS AT THE TOP OF PAGE 3 AND THAT
WOULD GO TO OHRP.
THAT'S BASICALLY THE MOTION.
THE HOPE WHICH I GUESS WE CAN'T
VOTE ON A HOPE, THAT OHRP WOULD
CONSIDER THIS A DIRECTION WORTH
EXPLORING FURTHER IN WHICH CASE
THEY WOULD THEN CHARGE THE
SACHRP AND THE SUBCOMMITTEES
WITHIN SACHRP TO THEN DEVELOP
THIS FURTHER, AND THEN WITH THAT
OPPORTUNITY ONCE THAT WORK IS
DONE WOULD THEN COME BACK TO
THIS GROUP PRECISELY FOR THE
CONVERSATION WE HAD IN THE LAST
20 MINUTES OR SO AROUND HOW YOU
INTERPRET ENGAGEMENT AND MAKE
SURE THAT THE SCIENCE OF
ENGAGEMENT, COMMUNITY
ENGAGEMENT, HOW WE INTERPRET
CONSENT AND SUPERVISION, ALL OF
THAT WORK WOULD BE DONE IN
APPLYING THIS RECOMMENDED
DEFINITION.
THE VOTE REALLY IS TO SAY THIS
DOCUMENT AS IT IS CAN GO TO OHRP
AS A DIRECTIONAL RECOMMENDATION
FOR FURTHER WORK ON THE PART OF
THIS GROUP.
THAT'S THE MOTION.
>> AND LINDA HAS SECONDED.
>> ONE QUESTION BEFORE I DO
THAT, IT WOULD INCLUDE A
RECOMMENDATION, INCLUDING THAT
SACHRP WOULD LOOK AT THE
DEFINITION AS WELL, CORRECT?
IT WOULD NOT JUST BE HERE IS THE
DEFINITION, MOVE ON, BUT IT
WOULD BE A RECOMMENDATION TO
LOOK AT THE ENTIRE DOCUMENT, ALL
THE LANGUAGE IN IT.
>> RIGHT, PRESUMABLY OHRP WOULD
SEEK OUR ADVICE ON THAT.
>> OKAY.
>> I'M FAIRLY CONFIDENT THEY
WOULD PROBABLY DO THAT IF THEY
THOUGHT THERE WAS MERIT IN THIS
APPROACH.
>> ANY OTHER LAST COMMENTS
BEFORE WE VOTE ON THIS?
LET'S VOTE.
ALL IN FAVOR OF THE MOTION?
ANY OPPOSED?
AND ANY ABSTENTIONS?
SO THE MOTION PASSES.
ALL RIGHT.
WE'RE GOING TO BREAK FOR LUNCH.
AND FOR THOSE OF YOU WHO ARE
ONLINE WE WILL BE RECONVENING AT
2:00 EASTERN TIME.
>>MOST OF OUR
AFTERNOON DEVOTED TO THE NIH
POLICY FOR DATA MANAGEMENT AND
SHARING, PROTECTING PRIVACY ON
HUMAN RESEARCH PARTICIPANT DATA.
THIS PARTICULAR ACTIVITY IS
PROVIDING COMMENTS ON AN NIH
PROPOSAL, AND BECAUSE THERE IS A
DEADLINE FOR COMMENTS IF WE'RE
GOING TO DO THIS IT HAS TO BE
DONE AT THIS MEETING.
SO, ONCE AGAIN, THIS WILL BE --
IT WILL BE IMPORTANT FOR US TO
MAKE VERY SPECIFIC CHANGES IF WE
WANT THEM.
WE CAN'T MAKE BIG PICTURE
SUGGESTIONS TO THE AUTHORS OF
THIS BECAUSE THERE WON'T BE TIME
TO IMPLEMENT THOSE.
TAUNTON PAINE WILL GIVE AN
OVERVIEW AND DAVID WILL TALK
THROUGH OUR COMMENTS.
>> GREAT.
CAN YOU HEAR ME?
IS THIS THE CORRECT MICROPHONE?
>> THAT'S THE CORRECT MIC BUT
IT'S VERY FAINT.
>> MAYBE I'LL TRY ADJUSTING.
>> SPEAK AS LOUDLY AS POSSIBLE.
THEY SEEM TO BE HAVING TECH
ISSUES WITH THAT MIC.
>> THANK YOU.
I'M TAUNTON PAINE, DIRECTOR OF
SCIENTIFIC DATA SHARING POLICY
DIVISION IN OFFICE OF SCIENCE
POLICY AT NIH.
I JUST WANTED TO GIVE YOU SOME
BACKGROUND ON THE DATA
MANAGEMENT AND SHARING POLICY,
AND ASSOCIATED SUPPLEMENTAL
INFORMATION THAT WE'VE DEVELOPED
WHICH IS IN DRAFT FORM THAT WE
PUBLISHED FOR PUBLIC COMMENT
EARLIER THIS YEAR.
JUST AS PREPARATION FOR YOUR
DISCUSSION.
AS YOU PROBABLY KNOW, WE ISSUED
THE DATA MANAGEMENT AND SHARING
POLICY IN OCTOBER 2020, AFTER A
LONG PERIOD OF DEVELOPMENT AND
PUBLIC COMMENT THROUGH SORT OF
ENGAGEMENT WITH STAKEHOLDERS AT
DIFFERENT POINTS.
WE ALSO CONSULTED SECRETARY'S
ADVISORY COMMITTEE FOR HUMAN
RESEARCH PROTECTIONS ON DRAFT
POLICY IN EARLY 2020 AND WORKED
TO INCORPORATE SOME OF THOSE
INTO THE FINAL POLICY AND INTO
THE DOCUMENT THAT I'LL TELL YOU
ABOUT TODAY.
AND THE POLICY IS NOT YET IN
EFFECT.
IT WAS ISSUED IN OCTOBER 2020
BUT WE WANTED TO GIVE PEOPLE
TIME TO IMPLEMENT IT.
SO IT'S TAKING EFFECT FOR NEW
AND COMPETING AWARDS BEGINNING
IN JANUARY 25, 2023, AND
AFTERWARDS.
SO, THE POLICY ITSELF IS
RELATIVELY STRAIGHT FORWARD.
IT ONLY HAS TWO REQUIREMENTS,
SUBMISSION OF DATA MANAGEMENT
AND SHARING PLAN FOR ALL
NIH-FUNDED RESEARCH, SO GRANTS,
CONTRACTS, COOPERATIVE
AGREEMENTS, THAT WOULD GENERALLY
DESCRIBE HOW, WHERE, AND WHEN
SCIENTIFIC DATA WILL BE SHARED.
AND IT ALSO REQUIRES COMPLIANCE
WITH THE VERSION OF THE PLAN
THAT IS APPROVED BY THE NIH
INSTITUTE CENTER OR OFFICE
FUNDING THE RESEARCH.
IT WILL ACTUALLY BECOME
EFFECTIVE FOR NEW AND COMPETING
AWARDS SUBMITTED FOR THE JANUARY
25, 2023, RECEIPT DATE AND LATER
AT WHICH POINT FOR THOSE AWARDS
IT WILL START TO REPLACE THE
2003 DATA SHARING POLICY FOR
THOSE WHO ARE FAMILIAR WITH THAT
ONE.
SO, I WON'T GO THROUGH THIS IN
DETAIL.
THE NIH HAS ISSUED SORT OF A
RECOMMENDED SET OF ELEMENTS OF A
DATA MANAGEMENT AND SHARING
PLAN.
I WANT TO DRAW YOUR ATTENTION TO
THE ACCESS DISTRIBUTION AND
REUSE CONSIDERATION SINCE
GENERALLY SPEAKING IF THERE ARE
GOING TO BE LIMITATIONS THAT CAN
BE ANTICIPATED FOR THE SHARING
OF DATA, WE WOULD EXPECT THOSE
TO BE DESCRIBED IN THAT SECTION.
SO IT IS SOMETHING WE WANT TO
HEAR ABOUT.
AND IN GENERAL, THE POLICY
REQUIRES THE SUBMISSION OF DATA
MANAGEMENT AND SHARING PLAN AND
COMPLIANCE WITH THAT PLAN.
IT DOES NOT DIRECTLY REQUIRE
DATA SHARING.
WHAT IT DOES EXPECT IS THAT IN
DEVELOPING THEIR DATA MANAGEMENT
AND SHARING PLANS, RESEARCHERS
WILL MAXIMIZE APPROPRIATE
SHARING RECOGNIZING THERE ARE
CERTAIN JUSTIFIABLE ETHICAL,
LEGAL OR TECHNICAL FACTORS THAT
MAY NECESSITATE LIMITING SHARING
TO SOME DEGREE OR IN SOME CASES
EVEN PRECLUDE SHARING ENTIRELY.
WE'VE PROVIDED SOME EXAMPLES OF
THESE THAT WE WOULD GENERALLY
CONSIDER TO BE JUSTIFIABLE SUCH
AS WHEN INFORMED CONSENT WILL
NOT PERMIT OR WOULD LIMIT THE
SCOPE OF SHARING OR USE, IF
PRIVACY OR SAFETY OF RESEARCH
PARTICIPANTS WOULD BE
COMPROMISED AND AVAILABLE
PROTECTIONS ARE NOT SUFFICIENT
OR IF THERE'S AN EXPLICIT
FEDERAL, STATE, LOCAL OR TRIBAL
LAW REGULATION OR POLICY THAT
WOULD PROHIBIT DISCLOSURE.
THESE ARE EXAMPLES OF WHAT WE
WOULD CONSIDER APPROPRIATE TO BE
STATED IN PLANS AS A JUSTIFIABLE
REASON FOR HAVING TO LIMIT
SHARING IN SOME WAY.
ALONGSIDE THE POLICY WE'VE
DEVELOPED A NUMBER OF ADDITIONAL
RESOURCE, SOME PUBLISHED WITH
THE POLICY IN OCTOBER 2020,
OTHERS OF WHICH WE SORT OF
DEVELOPED SINCE THEN.
SO EARLIER THIS YEAR NIH
ACTUALLY ISSUED A NEW RESOURCE
TO HELP PEOPLE THINK THROUGH HOW
TO ADDRESS FUTURE USE AND
SHARING OF DATA AND SPECIMENS IN
INFORMED CONSENT FORMS.
IT'S NOT A REQUIREMENT TO USE
IT.
IT'S MORE OF A POINTS TO
CONSIDER DOCUMENT WITH SUGGESTED
LANGUAGE THAT CAN BE MODIFIED.
WE ALSO ISSUED TWO DRAFT
DOCUMENTS, ONE IN A TRIBAL
CONSULTATION BEGINNING WITH A
DRAFT POLICY IN 2009 ON
RESPONSIBLE MANAGEMENT AND
SHARING OF DATA WHEN YOU ARE
DEVELOPING A DATA MANAGEMENT AND
SHARING PLAN IN A RESEARCH
PROJECT THAT INVOLVES WORKING
WITH AMERICAN INDIAN OR ALASKA
NATIVE TRIBES OR COMMUNITIES.
AND SO THAT WENT OUT FOR PUBLIC
COMMENT IN JANUARY.
AND WE'RE WORKING THROUGH THE
PUBLIC COMMENTS ON THAT NOW.
THE SECOND DRAFT THAT WENT OUT
FOR PUBLIC COMMENT WAS ISSUED IN
MAY THAT WE'LL BE TALKING ABOUT
TODAY WHICH IS THE SUPPLEMENTAL
INFORMATION FOR PROTECTING
PRIVACY WHEN SHARING HUMAN
RESEARCH PARTICIPANT DATA.
SO, I WON'T GO THROUGH IN
DETAIL.
IT'S AVAILABLE ONLINE.
IT'S RELATIVELY SHORT AND IN
GENERAL IT'S TRYING TO RESPOND
TO THE NEED TO UPDATE THE
GUIDANCE THAT WAS PROVIDED FOR
THE 2003 DATA SHARING POLICY ON
HOW TO PROTECT PRIVACY UNDER
THAT POLICY.
IT'S ALSO RESPONDING TO
ADDITIONAL REQUESTS FOR
CLARIFICATION WE'VE HEARD IN THE
PUBLIC COMMENTS OR SINCE THEN IN
OUR DISCUSSIONS WITH THE
RESEARCH COMMUNITY WHICH HAVE
BEEN ONGOING SINCE WE ISSUED THE
POLICY IN OCTOBER 2020.
AND ALSO WE WANTED TO RESPOND TO
CERTAIN RECOMMENDATIONS THAT
SACHRP MADE ON THE DRAFT POLICY
SUCH AS RECOMMENDATION THAT DATA
USE AGREEMENTS INCLUDE
STIPULATION THAT DATA RECIPIENTS
WOULD HAVE TO AGREE NOT TO
ATTEMPT TO REIDENTIFY
INDIVIDUALS WHICH WE DO ACTUALLY
I THINK HAVE IN THE SUPPLEMENTAL
INFORMATION ITSELF.
AND IN GENERAL, APPROACH WE'VE
TAKEN HERE IS TO TRY TO PROVIDE
GUIDANCE TO RESEARCHERS AND
INSTITUTIONS, IN THE GENERAL
SENSE OF THE WORD, WHILE
PRESERVING THEIR FLEXIBILITY TO
BE ABLE TO IMPLEMENT THIS AS
THEY SEE FIT.
RECOGNIZING THERE ARE
DIFFERENCES IN DISCIPLINES AND
IN CONTEXT THAT MAY BE IMPORTANT
TO TAKE INTO ACCOUNT HERE.
IT'S NOT INTENDED TO ESTABLISH
BINDING REQUIREMENTS.
AND SO I DO WANT TO SAY WE'VE
RECEIVED A NUMBER OF PUBLIC
COMMENTS ON THIS AND WE'VE BEEN
REVIEWING THOSE CAREFULLY AND WE
LOOK FORWARD TO SACHRP'S
RECOMMENDATIONS.
>> ANY QUESTIONS FOR TAUNTON
BEFORE WE TURN IT OVER TO DAVID?
OKAY.
THANK YOU.
ALL RIGHT.
DAVE BORASKY, YOU'RE GOING TO
TAKE US THROUGH THE SACHRP
COMMENTS DRAFT.
>> DAVID, YOU HAVE TO FIRST GO
TO THE ZOOM AND SHARE YOUR
SCREEN THROUGH THE ZOOM.
>> GOT IT.
ALL RIGHT, GREAT.
THANKS FOR THAT INTRODUCTION,
TAUNTON.
WE HAD THE SAME -- THE PLEASURE
OF GETTING SIMILAR BACKGROUND IS
HE SUBCOMMITTEE MEETING WHICH WE
FOUND HELPFUL AS WE WORKED ON
PULLING TOGETHER THESE
DOCUMENTS.
SO, AS DOUG ALREADY NOTED, THIS
IS A TIME LIMITED REQUEST TO GET
THIS INFORMATION BACK OUT TO NIH
AND SO WE'LL DO OUR BEST TO I
THINK WORK THROUGH THIS DOCUMENT
EFFICIENTLY AND THEN IF THERE
ARE ANY CHANGES OR CORRECTIONS
WE WILL -- I'M HERE TOMORROW SO
WE'LL BE ABLE TO USE THE
OVERNIGHT TO GET THINGS CLEANED
UP AND PUT BACK BEFORE YOU IF
NECESSARY.
SO TAUNTON GAVE THE BACKGROUND
ON THE DOCUMENT.
THAT'S WHAT'S IN THE BACKGROUND
SECTION ON THIS.
I WOULD SAY OVERALL, AS YOU SAW
WHEN YOU HOPEFULLY READ THROUGH
THE DOCUMENT AHEAD OF TIME, BUT
THE WAY THE DOCUMENT IS
ORGANIZED FIRST OF ALL I THINK
WE'RE ALL GOING TO SAY WE AGREE
PROTECTING THE PRIVACY OF
RESEARCH PARTICIPANTS IS
IMPORTANT, AND THAT IT IS USEFUL
FOR THE IMPACTED COMMUNITY TO
HAVE GUIDANCE ON HOW TO FOLLOW
AND COMPLY WITH THE NIH POLICY
ALTHOUGH THE NIH IS CLEAR THIS
IS NOT A GUIDANCE DOCUMENT, BUT
IT IS MEANT TO HELP THAT
COMMUNITY OF RESEARCHERS WORKING
WITH THIS DATA AND SHARING IT
AND ARE RECIPIENTS OF IT.
WITH THAT IN MIND, YOU KNOW, WE
AGREE IT'S IMPORTANT BUT THERE
ARE A NUMBER OF AREAS WHERE WE
THINK THE DOCUMENT COULD BE
IMPROVED.
ITS CURRENT STRUCTURE IS BROKEN
DOWN BETWEEN POINTS TO CONSIDER,
BEST PRACTICES, AND WHATEVER THE
THIRD BUCKET IS.
AND WE THINK THERE'S SOME
OPPORTUNITY TO REFINE THOSE AND
MAYBE REORGANIZE AND SCENARIOS
WHERE WE BELIEVE ADDITIONAL
INFORMATION WOULD BE BENEFICIAL
TO THE INTENDED COMMUNITY OF
RECIPIENTS OF THIS DOCUMENT.
SO, I'LL START WITH JUST THE
GENERAL OBSERVATIONS BEFORE WE
GET INTO THE SPECIFICS OF THE
DOCUMENT.
AND, YOU KNOW, HERE I THINK ONE
OF THE BIGGEST THINGS THE
SUBCOMMITTEE MEMBERS NOTED AS WE
STARTED TO LOOK AT THE DOCUMENT
WAS THAT THERE ARE A NUMBER OF
TERMS THAT ARE SORT OF USED
THROUGHOUT THAT DON'T MAKE IT
CLEAR WHAT IS EXPECTED OR, YOU
KNOW, WHAT MIGHT BE REQUIRED BY
THE POLICIES, REFLECTED IN THIS
DOCUMENT, WHAT IS REALLY A BEST
PRACTICE OR WHAT IS SOMETHING TO
JUST THINK ABOUT AND I THINK WE
THINK THAT THAT SORT OF SOWS
CONFUSION KEEPING TRACK OF WHICH
ARE OBLIGATIONS, AND WHICH ARE
SOMETHING THAT'S MAYBE NICE TO
DO.
WE ALSO IN THE PARAGRAPH AT LINE
31 HAD CONCERNS ABOUT STATEMENTS
AROUND CERTIFICATES OF
CONFIDENTIALITY AND THE WAY THEY
WERE DESCRIBED IN THIS DOCUMENT,
AND WHEN WE GET TO THAT SECTION
LATER IT WILL BE MORE CLEAR, BUT
THAT WAS ANOTHER POINT OF
CONCERN WITH THE DOCUMENT.
AND THEN IN GENERAL THE DOCUMENT
OFTEN TALKS ABOUT USING
STANDARDIZED TEMPLATES FOR DATA
SHARING.
BUT DOESN'T REALLY TALK ABOUT
THE NIH DEVELOPING ONE.
SO THAT WILL BE ALSO A THEME YOU
SAW IN THE DOCUMENT WHICH IS YOU
SEEM TO THINK TEMPLATES ARE A
GREAT IDEA, MAYBE YOU SHOULD
CREATE ONE THAT MEETS THE
REQUIREMENTS OF THE POLICY SO
THAT'S ALSO A FAMILIAR THEME
THROUGHOUT THE DOCUMENT.
AND THEN THE FINAL GENERAL
OBSERVATION IS THAT WE'RE
TALKING ABOUT DATA PRIVACY AND
IDENTIFIABLE PRIVATE
INFORMATION, AND THAT IS
SOMETHING THAT RECEIVED ITS OWN
DEFINITION IN REVISED COMMON
RULE WITH THE REQUIREMENT THAT
DEFINITION BE EXAMINED ON A
PERIODIC BASIS, THAT AS FAR AS
WE KNOW HAS NOT BEEN INITIATED
YET.
SO THERE'S ALSO A -- WHILE MOST
COMMENTS ARE DIRECTED AT NIH
THERE'S A RECOMMENDATION THAT
THAT REVIEW PROCESS FOR THE
DEFINITION OF IDENTIFIABLE
PRIVATE INFORMATION BE INITIATED
BY OHRP.
SO ANY QUESTIONS OR COMMENTS ON
THIS GENERAL OBSERVATION
SECTION?
ALL RIGHT.
I'M GOING TO MOVE TO THE
OPERATIONAL PRINCIPLES SECTION
AND WATCH HANDS ON THE SCREEN
TOO.
THE OPERATIONAL PRINCIPLES IS
THE FIRST CHUNK OF THE DOCUMENT
WHERE THEY BREAK THINGS DOWN.
WE DIDN'T HAVE COMMENTS ON ALL.
THAT'S WHY YOU DON'T SEE NUMBER
1 HERE.
THERE ARE ACCEPT OPERATIONAL
PRINCIPLES IN THE DOCUMENT.
I DON'T THINK THERE'S ANYTHING
OBJECTIONABLE.
WE JUST HAVE CRITICAL COMMENTS
ABOUT A HANDFUL OF THEM.
SO THE SECOND PRINCIPLE TALKS
ABOUT APPROPRIATE PROTECTIONS,
AND SO ON.
AND HERE THE THEME THAT CAME OUT
OF THE SUBCOMMITTEE DISCUSSIONS
WAS THIS IDEA THE SECOND
OPERATIONAL PRINCIPLE SOUNDS
MORE LIKE A BEST PRACTICE AS IT
DESCRIBES THE ACTIONS TO BE
TAKEN BY RESEARCHERS AND THE
INSTITUTION, BUT AS A BEST
PRACTICE IT'S STILL NOT CLEAR TO
THE SUBCOMMITTEES WHAT THE
INSTITUTIONAL -- WHAT
INSTITUTIONAL COMPONENT OR
COMPONENTS WOULD BE EXPECTED TO
DO THIS WORK.
THAT COULD HAVE BEEN IN THE
BACKGROUND, THAT'S ALSO A THEME
THAT THERE'S OFTEN TALK ABOUT
DOING CERTAIN TIMES OF REVIEWS
OR CERTIFICATIONS BUT NOT A
CLEAR INDICATION OF WHO MIGHT BE
DOING THAT OR LEADING IT WITHIN
RESEARCH PROGRAM AT AN
INSTITUTION IT APPLIES.
THERE'S VARIABILITY AMONG
INSTITUTIONS, SOME ARE LARGE
WITH ROBUST HRPPs WITH
MULTIPLE COMPONENTS THAT MAY OR
MAY NOT INCLUDE THE IRB THAT
WOULD BE INVOLVED IN THIS, IN
OTHER PLACES MAY BE ORGANIZED
DIFFERENTLY.
SOME CLARITY AROUND, YOU KNOW,
WHAT ENTITY WITHIN AN
INSTITUTION WOULD BE DOING THESE
ASSESSMENTS, WOULD BE I THINK
HELPFUL TO INSTITUTIONS
ATTEMPTING TO FOLLOW THE POLICY.
LOIS?
>> IT SEEMED THAT -- I'M SORRY.
SO THERE ARE DIFFERENT WAYS THAT
LARGER INSTITUTIONS ARE SET UP
AND HAVE MULTIPLE COMPONENTS AND
IT MIGHT BE DIFFERENT IN
DIFFERENT PLACES BUT WHERE THEY
WOULD BE MOST LOGICALLY LOCATED.
I WONDER IF AT ISSUE IS MORE
THAT INSTITUTIONS HAVE A
RESPONSIBILITY FOR IDENTIFYING
WHICH OF THEIR INSTITUTIONAL
COMPONENT OR COMPONENTS WILL
UNDERTAKE THE ASSESSMENT.
>> FAIR POINT.
>> SO I HAD A LITTLE LANGUAGE ON
THAT IF YOU WANT.
>> THAT WOULD BE GREAT.
LANGUAGE IS DEFINITELY HELPFUL.
>> WANT ME TO GIVE IT TO YOU
NOW?
>> SURE.
>> JUST ONE SENTENCE.
IT COULD BE ADDED.
I DON'T THINK IT'S INCONSISTENT
WITH ANYTHING YOU SAID.
TO ME, IT WAS A LOGICAL
CULMINATION OF WHAT YOU HAD SAID
BEFORE, TO CONSIDER THIS
SENTENCE AT THE END AFTER PLUS
OTHERS, WHICH WOULD BE
INSTITUTIONS HAVE A
RESPONSIBILITY TO IDENTIFY THE
INSTITUTIONAL COMPONENT OR
COMPONENTS, USING YOUR LANGUAGE
FROM ABOVE, THAT UNDERTAKE SUCH
ASSESSMENTS AND TO CHARGE SUCH
COMPONENT OR COMPONENTS WITH
DOING SO.
THAT'S MORE LIKE GUIDANCE
LANGUAGE RATHER THAN THINKING
NIH NEEDS TO THINK ABOUT THIS SO
I WROTE IT.
>> JUST SO YOU KNOW, THIS IS THE
KEYBOARD, I CAN SPELL AND TYPE.
THE KEYBOARD IS A LITTLE --
>> OH.
I'LL READ IT AGAIN.
INSTITUTIONS HAVE A
RESPONSIBILITY TO IDENTIFY THE
INSTITUTIONAL COMPONENT OR
COMPONENTS THAT WOULD UNDERTAKE
SUCH ASSESSMENTS AND TO CHARGE
SUCH COMPONENT OR COMPONENTS
WITH DOING SO.
WE MIGHT WANT TO SOFTEN THAT.
I JUST DRAFTED, THE COMMENTS, WE
WERE WRITING THE GUIDANCE
OURSELVES WHICH WE'RE NOT, SO,
YOU KNOW, NIH MIGHT WANT TO
CONSIDER REQUIRING INSTITUTIONS
TO IDENTIFY, SOMETHING LIKE
THAT.
I MEAN, UNLESS ANYBODY SEES A
PROBLEM WITH THAT.
OKAY.
>> NO, I THINK THAT'S QUITE
HELPFUL ACTUALLY, IN TERMS OF
GIVING NIH SOME GUIDANCE, YOU
KNOW, AS TO HOW WE THINK PART OF
THIS COULD BE RESOLVED.
ALL RIGHT.
INSTITUTIONS HAVE RESPONSIBILITY
TO IDENTIFY THE INSTITUTIONAL
COMPONENT OR COMPONENTS.
>> THAT WILL UNDERTAKE SUCH
ASSESSMENTS.
COULD CHARGE SUCH COMPONENT OR
COMPONENTS WITH DOING SO.
>> OKAY.
>> LIKE I SAID, I MEAN, AS YOU
GUYS GO BACK, IF YOU'RE GOING
BACK YOU MIGHT WANT TO SAY
INSTEAD THAT NIH MIGHT CONSIDER
MAKING CLEAR THAT, AND THEN YOU
COULD PUT THAT RIGHT BEFORE THE
WHOLE THING.
>> I'LL TELL YOU WHAT.
I'M-- THIS KEYBOARD IS HIGHLY
UNCOOPERATIVE.
I CAN REMEMBER WHAT THE REST OF
THAT IS.
>> YEAH, SURE.
>> OKAY.
THE THIRD PRINCIPLE HAS --
DISCUSSES HAVING A ROBUST
CONSENT PROCESS, AND IT
INDICATES THAT THE DMS POLICY
DOES NOT REQUIRE SHARING OF DATA
IN ORDER TO PARTICIPATE.
AND DON'T DISAGREE WITH THAT BUT
WE NOTED THAT THE POLICY ALSO
DOESN'T PROHIBIT REQUIRING DATA
SHARING IN ORDER TO PARTICIPATE,
AND SOME SUBCOMMITTEE NOTED --
SEVERAL NOTED THERE MAY BE
VALUABLE REASONS AND OTHER
POLICIES AND/OR REGULATORY
REQUIREMENTS FOR DATA TO BE
SHARED.
PRETTY STRAIGHTFORWARD.
SKIP?
>> IS THERE AN AMBIGUITY IN HERE
BETWEEN THE INSTITUTION MAKING A
DECISION TO SHARE THE DATA AND
WHETHER OR NOT THE CONSENT TO
SHARING THAT DATA IS A
REQUIREMENT FOR PARTICIPATION?
WHAT'S THE INTENT HERE?
IN OTHER WORDS, IF THERE'S A
TRIAL THAT OFFERS ME THE
POSSIBILITY OF DIRECT BENEFIT,
COULD I NOT ENTER THAT STUDY, IF
THERE WAS A REASON TO SAY YOUR
DATA HAD TO BE SHARED?
I READ THIS TO SAY THAT, YOU
KNOW, WHO IS IT THAT'S BEING
REQUIRED TO SHARE THE DATA, IS
IT THE INSTITUTION OR
PARTICIPANT MUST AGREE TO
SHARING OF DATA IN ORDER TO BE
IN THE TRIAL, I INTERPRET NIH
POLICY TO IMPLY YOU WOULDN'T
WANT TO REQUIRE SHARING OF DATA
TO BE IN A TRIAL.
BUT SEEING AMBIGUITY, TAUNTON IS
SHAKING HIS HEAD, THAT RAISES AN
ETHICAL QUESTION IN MY MIND
WHETHER WE REQUIRE A PARTICIPANT
TO BE IN A TRIAL THAT REQUIRES
DATA SHARING TO BE A BENEFIT.
>> I DON'T HAVE A READY EXAMPLE
OF THAT, BUT TRIALS IMPOSE ALL
TYPES OF BURDENS OR REQUIREMENTS
UPON SUBJECTS AS A CONDITION OF
PARTICIPATION WITHOUT REGARD TO
THE DIRECT BENEFIT COMPONENT OF
IT.
I COULDN'T SEE WHAT TAUNTON --
HE'S BEHIND THIS PILLAR.
HE'S WELCOME TO COMMENT IN TERMS
OF AMBIGUITY, THEIR END OR OURS.
>> WHAT THIS BASICALLY SAYS, DMS
POLICY DOES NOT REQUIRE SHARING
OF DATA IN ORDER TO PARTICIPATE
SO I INTERPRET THAT TO BE THE
NIH WOULD NOT THAT A FILE THAT
OFFERS POSSIBLY DIRECT BENEFIT
THATTED -- THAT IN ORDER FOR ME
TO PARTICIPATE I DON'T HAVE TO
SHARE MY DATA, YOU BASICALLY
IMPLY THEN THERE COULD BE
REASONS THAT WOULD BE
APPROPRIATE TO SAY I CAN'T
PARTICIPATE UNTIL OF IN THE
TRIAL IF I DON'T AGREE TO
SHARING THE DATA WHICH IS
DIRECTED TO THE PARTICIPANT, NOT
THE INSTITUTION.
THAT'S THE AMBIGUITY.
I'M NOT SURE I WOULD AGREE WITH
THE IDEA IF THERE'S A TRIAL, IT
GETS INTO WHETHER THERE ARE
OTHER OPTIONS, ET CETERA.
>> YEAH, I DON'T KNOW HOW TO
RESOLVE IT.
I DON'T KNOW, LINDA IS YOUR HAND
UP?
IF OTHERS HAVE THOUGHTS ON THAT?
>> CAN I ASK TAUNTON A QUESTION?
>> IS THE INTENT TO SAY YOU
WOULD NOT REQUIRE A PARTICIPANT
TO SHARE DATA AS A CONDITION IN
PARTICIPATION OR DIRECT BENEFIT
OR ARE YOU TALKING ABOUT THE
INSTITUTION I GUESS?
>> THE INTENT IS TO CLARIFY WHAT
THE POLICY IS.
>> I DON'T THINK THAT MIC IS ON.
SPEAK LOUDLY.
>> I THINK THE INTENT IS TO
CLARIFY WHAT THE EXPECTATION OF
THE POLICY IS.
BECAUSE I THINK WE DON'T WANT A
SITUATION WHERE PEOPLE ARE
SUGGESTING THAT IT'S THE POLICY
THAT IS REQUIRING THEM TO DO A
CERTAIN THING, IF THE POLICY
DOESN'T ACTUALLY DOES NOT
ESTABLISH THAT.
IT DOESN'T TAKE A STANCE WHETHER
CONSENT HAS TO BE OBTAINED IN
CERTAIN CONDITIONS OR NOT.
IT DOES A LOT OF REMINDING
PEOPLE ABOUT IMPORTANCE OF
CONSENT BUT IT DOES NOT REQUIRE
-- YOU KNOW, SET THIS
EXPECTATION HERE.
SO WHAT WE WANT TO AVOID IS A
SITUATION WHERE PEOPLE SAY DATA
MANAGEMENT AND SHARING POLICY IS
REQUIRING US TO DO THIS
PARTICULAR THING BECAUSE IT'S
NOT.
>> I MEAN, AS OUR -- THE
STATEMENT HERE IS CONSISTENT
WITH THE VIEW THE POLICY DOES
NOT REQUIRE NOR DOES THE POLICY
PROHIBIT, SO FROM LOGICAL POINT
OF VIEW THE STATEMENT IS TRUE
BUT IT IS A DIFFERENT TONE
BASICALLY.
SO THE STATEMENT IS TRUE BUT
IT'S A VERY DIFFERENT TONE.
>> YEAH, NO, I AGREE.
YOU KNOW, I DON'T KNOW -- SO
PART IS WHAT'S THE PLEASURE OF
SACHRP HERE?
WE DON'T HAVE TO INCLUDE THIS
RESPONSE TO PRINCIPAL 3, THE
SUBCOMMITTEE'S THOUGHTS ON IT,
AND I THINK IN THE GRAND SCHEME
OF THINGS IT'S NOT -- IT'S
CERTAINLY NOT THE MOST IMPORTANT
PIECE OF THIS DOCUMENT I DON'T
THINK.
SO I HAVE NO PROBLEM WITH IF
CONSENSUS IS IT'S NOT ADDING ANY
VALUE TO THE OVERALL DISCUSSION
IT CAN COME OUT.
I JUST NEED TO KNOW WHAT ALL OF
YOU THINK ABOUT IT.
>> I THINK IT WOULD BE -- I
AGREE WITH THE TONE ISSUE.
I UNDERSTAND TAUNTON'S ANSWER,
WE'RE NOT SAYING ANYTHING ABOUT
THIS, BUT ESPECIALLY FOR SOME
REASON WITH PROHIBIT, IT HAS
THIS TONE OF, YOU KNOW, APPROVAL
OR WE THINK IT'S -- I'M
OVERSTATING BUT WE THINK ITS
JUST FINE AND GOOD FOR PEOPLE
TO -- OR INVESTIGATORS AND
INSTITUTIONS TO REQUIRE DATA
SHARING EVEN THOUGH THE STUDY
CARRIES POSSIBILITY OF A DIRECT
BENEFIT.
SO, I AGREE.
IT MADE ME UNCOMFORTABLE WHEN I
READ IT THE FIRST TIME.
WELL, THE POLICY DOESN'T SAY
THIS BUT I AGREE, I THINK
THERE'S A QUESTION OF TONE.
>> IF I CAN MAKE A SUGGESTION
HAVING RAISED THE ISSUE, AT
MINIMUM PROHIBIT COULDN'T BE
ITALICIZED.
ONE COULD HAVE A SENTENCE ALONG
THE LINES THIS WOULD BE A PRETTY
HIGH BAR, THERE WOULD HAVE TO BE
PRETTY DARN GOOD REASONS TO
REQUIRE.
YOU SAY THERE MAY BE VALUABLE
REASONS, IT'S HARD TO IMAGINE
WHAT THOSE MIGHT BE FRANKLY.
AND I COULD LIVE WITH THAT.
THE OTHER OPTION IS TO TAKE IT
OUT, BUT I WOULD DEFER TO THE
REST OF THE GROUP IF THEY FEEL
STRONGLY.
IT'S A HIGH BAR TO MAKE A
CONDITION OF PARTICIPATION
RELEASE OF RECORDS.
>> LET ME MAKE ONE POINT IN THIS
REGARD.
I'M AGNOSTIC WHETHER YOU GUYS
DECIDE TO KEEP THIS IN OR NOT
BUT ASIDE FROM NIH DATA SHARING
POLICY, LEAVING THAT ASIDE, WHEN
YOU HAVE FUNDED RESEARCH AND THE
INVESTIGATOR WANTS TO PUBLISH
THAT RESEARCH IN MANY OF THE
JOURNALS LIKE BMJ FOR EXAMPLE
YOU'RE ACTUALLY REQUIRED TO MAKE
THE BASELINE DATA IN AN
ANONYMIZED FORM AVAILABLE AND TO
SHARE THE DATA.
SO IF YOU HAVE PEOPLE WHO WANT
TO BE IN THE STUDY, WHETHER
DIRECT BENEFIT OR NOT, DON'T
WANT THEIR ANONYMIZED OR
DE-IDENTIFIED DATA TO BE SHARED,
THAT'S GOING TO PREVENT THE
SHARING OF THOSE DATA FOR THE
PURPOSE OF FULFILLING THE
MANDATES BY JOURNALS, DATA BE
MADE AVAILABLE EITHER ON THE
WEBSITE OR BY REQUEST.
LEAVING NIH ASIDE, THAT IS A
PROBLEM.
>> FAIR POINT.
I MEAN IN THE PRINCIPLE IT
DOESN'T TALK ABOUT DE-IDENTIFIED
DATA.
SO IF YOU ADDED DE-IDENTIFIED IN
FRONT OF DATA IT WOULD CERTAINLY
-- AND GOT RID OF ITALICS ON
PROHIBIT THAT WOULD MAKE IT A
MUCH DIFFERENT TONE.
>> JUST TO BE CLEAR, MY
UNDERSTANDING OF THE WHOLE
DOCUMENT WE'RE TALKING ABOUT
DE-IDENTIFIED OR ANONYMIZED
DATA, NOT TALKING ABOUT SHARING.
>> THAT'S FINE.
I WAS READING IT IN ISOLATION
BUT IF YOU ADD DE-IDENTIFIED IN
FRONT OF DATA THAT'S CERTAINLY
REINFORCING THAT.
MUCH LESS CONCERNING.
>> OTHER COMMENTS OR
SUGGESTIONS?
FOURTH PRINCIPLE HAS TO DO WITH
INSTITUTIONAL REVIEW OF THE
CONDITIONS FOR DATA SHARING.
AND THE PLACEMENT OF LIMITATIONS
ON FUTURE USE.
AND THIS IS ANOTHER ONE WHERE
THE BASIC THEME HERE WAS JUST
THE NOTION ABOUT INSTITUTIONAL
REVIEW AND WHO WOULD DO THAT.
SO, THE SUGGESTION THAT CAME OUT
OF THE COMMITTEE WAS TO CHANGE
INSTITUTIONAL REVIEW TO REVIEW
BY APPROPRIATE INSTITUTIONAL
COMPONENTS.
>> WHEN I WAS READING I HAD THE
SAME COMMENT AS BEFORE, MAYBE
ONE INSTEAD OF -- I THINK WHAT
SEEMS TO -- THAT NEEDS TO HAPPEN
IS THAT THERE'S AN
IDENTIFIABLE -- SOMEONE'S GOING
TO REVIEW IT, THE INSTITUTION
HAS TO TAKE RESPONSIBILITY FOR
FIGURING OUT SOMEBODY'S GOING TO
REVIEW IT, IT'S THEM IN THIS
INSTITUTION, AND THAT
INSTITUTION IT'S ANOTHER PLACE,
SAME COMMENT I HAD BEFORE IF YOU
WANT TO JUST LOOK AT THAT.
>> YEAH.
AND --
>> INSTEAD OF NIH -- INSTEAD OF
SAYING NIH NEEDS TO IDENTIFY
WHICH INSTITUTIONAL COMPONENT
COULD DO THIS IT SEEMS INSTEAD
NIH SHOULD SAY TO INSTITUTIONS,
YOU FIGURE OUT WHICH
INSTITUTIONAL COMPONENT WILL DO
THIS BUT MAKE SURE THERE IS ONE.
>> RIGHT.
>> YEAH, THIS ONE THE WORDING IS
DIFFERENT, SWITCHED TO REVIEW BY
APPROPRIATE INSTITUTIONAL
COMPONENTS WOULD SORT OF PUSH
THAT QUESTION BACK TO THE
INSTITUTION HOLDING THE DATA.
>> YOU MIGHT BE RIGHT.
I'LL KEEP LOOKING AT IT.
YOU CAN MOVE ON.
>> OKAY.
FIFTH PRINCIPLE ADDRESSED
COLLECTION OF DATA FROM WHAT THE
DOCUMENT CALLS NON-TRADITIONAL
RESEARCH SETTINGS, EXAMPLES ARE
CONSUMER REPORTS, PUBLIC HEALTH
SURVEILLANCE, NOTE THEY MAY
WARRANT -- ALSO WARRANT STRICT
PRIVACY CONSIDERATIONS, THE
SUBCOMMITTEE HAD DIFFICULTY.
WE DIDN'T SENSE CLEAR DIRECTION
COMING FROM IT AND THAT PERHAPS
SOME OF THE ELEMENTS OF THIS
PRINCIPLE SHOULD MOVE TO THE
BEGINNING OF THE DOCUMENT AND
TALK ABOUT THE EVOLVING NATURE
OF SOURCES OF DATA THAT MAY BE
IDENTIFIABLE AND PROMOTE PRIVACY
PROTECTIONS REGARDLESS OF THE
SOURCE.
AND TAKE IT OUT OF THESE
PRINCIPLES IN THAT SENSE.
AND THERE WAS SOME CONCERN SOME
OF THE SOURCES THAT ARE
IDENTIFIED HERE AREN'T
APPROPRIATELY CATEGORIZED AS
NON-TRADITIONAL PUBLIC HEALTH
SURVEILLANCE WAS EXPLICITLY
NOTED, THAT'S IN THE SUBSEQUENT
PARAGRAPH AT 98.
BUT EVEN THE MOBILE HEALTH
DEVICES AND SOCIAL MEDIA ARE
BECOMING MAINSTREAM SOURCES OF
DATA FOR A LOT OF RESEARCH, SO
WE HAD SOME CHALLENGES WITH THIS
PARTICULAR PRINCIPLE AND ALSO
CALLED OUT PREVIOUS
RECOMMENDATIONS BY SACHRP ON
ISSUES RELATED TO END USER
AGREEMENTS IN TERMS OF USE FOR
MOBILE DEVICES, CONSUMER DEVICES
THAT RECORD IDENTIFIABLE PRIVATE
DATA.
>> I REALLY LIKE THIS ONE, HOW
IT'S WORDED.
>> OH GOOD.
I WASN'T SURE IF YOU SAID REALLY
LIKE OR NOT LIKE.
YOU WERE NODDING SO I HOPE IT
WAS THE LIKE PART.
ANY OTHER COMMENTS OR
SUGGESTIONS FOR IMPROVEMENT?
PRINCIPLE 6 TALKS ABOUT
JUSTIFIABLE EXCEPTIONS TO
SHARING DATA REGARDLESS OF THE
SUFFICIENCY OF CONTROL AN
TECHNIQUE, RESEARCHERS SHOULD
OUTLINE JUSTIFICATIONS.
SUBCOMMITTEES, WE AGREED WITH
PRINCIPLES POINT THAT THERE WAS
EXCEPTION THAT NEEDS TO BE MADE.
HOWEVER, IN TERMS OF BEING A
GUIDANCE DOCUMENT IT DIDN'T SEEM
HELPFUL TO NOT SAY HERE ARE SOME
EXAMPLES WHAT THE JUSTIFICATIONS
MIGHT BE.
AND HOW AN INSTITUTIONAL
COMPONENT THAT'S REVIEWING THIS
MIGHT DETERMINE WHETHER OR NOT
THEY ARE JUSTIFIED.
SKIP?
>> THE QUESTION, CAN WE COME UP
WITH SOME IDEAS WHAT THAT MIGHT
BE OR IS THIS SIMPLY A STATEMENT
THAT WE DON'T KNOW EVERYTHING
AND MAYBE THERE'S SOMETHING WE
DON'T KNOW?
THIS GROUP CAN'T COME WITH AN
EXCEPTION, MAYBE NIH COULD.
DO YOU HAVE ONE IN MIND THAT I'M
NOT SAYING PUT IT IN BUT WHAT IN
YOUR MIND MIGHT BE ONE?
>> MY MEMORY OF THE SUBCOMMITTEE
MEETING WE DID NOT COME UP WITH
ANY OFF THE TOP OF OUR HEAD
EXAMPLES OF THIS.
>> THIS WOULD BE ASIDE FROM THE
TRIBAL EXCEPTION, THIS IS
DIFFERENT?
>> RIGHT.
>> THIS MAY OPEN THE DOOR TO SAY
WE MAY NOT KNOW EVERYTHING, IF
YOU THINK THERE'S EXCEPTION PUT
ANYTIME THE DOCUMENT.
>> YEAH.
>> IF A GROUP OF SMART PEOPLE
HAS NO EXCEPTION AT THE MOMENT
THIS MAY BE -- SO IT'S FINE TO
LEAVE IT IN BUT I CAN'T -- MAY
OR MAY NOT HAVE ONE IN OUR OWN
MIND.
IF WE DO SHOULD ADD AN EXAMPLE.
>> AGAIN, I THINK AT THE
SUBCOMMITTEE LEVEL WE DIDN'T,
AND THE NIH DOCUMENT CLEARLY
DOESN'T, BUT ALSO SEEMS TO
ACCEPT THE FACT MAY BE
JUSTIFIABLE EXCEPTIONS, SO
ANTICIPATING IT BUT WE DIDN'T
HAVE ANY EXAMPLES.
>> IT STRIKES ME AS LANGUAGE YOU
SEE IN ALL THE FDA GUIDANCE
DOCUMENTS WHICH SAY IF YOU HAVE
A BETTER IDEA PLEASE TELL US,
BASICALLY.
>> ALL RIGHT.
FOR NOW I'LL LEAVE IT AS IT IS.
AND THEN LINE 107 THE SEVENTH
PRINCIPLE OF DATA SHARING
PRACTICES, THIS MAKES SENSE FOR
THE SUBCOMMITTEE BUT WOULD SAY
PUT THIS IN THE BEGINNING, IN
THE INTRODUCTION, BECAUSE IT'S
JUST TALKING ABOUT RESPONSIBLE
DATA SHARING PRACTICES REQUIRE
COMMITMENT.
I MEAN, WE DIDN'T THINK IT FIT
WELL IN THE PRINCIPLES.
>> DO YOU WANT TO SAY ANYTHING
ABOUT THE NIH COMMITMENT TO
ENFORCE THE TERMS OF DATA USE
AGREEMENTS?
IS THERE ANYTHING THAT NIH WOULD
LIKE TO SAY MORE ABOUT HOW THEY
MAY DO IT?
DOES THE RESEARCH COMMUNITY NEED
TO KNOW THAT IS WHAT I'M ASKING.
>> WELL, I DON'T KNOW THE
ANSWER.
TAUNTON MIGHT KNOW.
I KNOW THAT WAS SOMETHING THAT
BRIEFLY CAME UP IN THE
SUBCOMMITTEE CALL BUT DIDN'T
MAKE IT INTO THIS DOCUMENT.
I DON'T REMEMBER WHY.
I THINK BECAUSE WE DIDN'T HAVE
AN ANSWER WE JUST SAID DOES
ANYBODY KNOW ANYTHING ABOUT THE
NIH HOW THEY INTEND TO ENFORCE
OR WHAT THE MECHANISM IS, AND WE
DIDN'T KNOW.
IF YOU THINK THERE'S A STATEMENT
TO PUT IN HERE THAT POINTS TO
THAT, I'M HAPPY TO TYPE IT OUT.
>> I DON'T HAVE.
>> THIS IS A REQUIREMENT TO
SUBMIT YOUR DATA SHARING PLAN AS
PART OF YOUR APPLICATION.
WHY WOULD COMPLIANCE BE
DIVERSITY ANY DIFFERENTLY THAN
THE GRANT?
IT'S A DOCUMENT THAT GOES IN
WITH THE GRANT.
IF YOU'RE OUT OF COMPLIANCE WITH
SOME PORTION OF THE GRANT NIH
CAN DO WHATEVER NIH DOES, I
DON'T KNOW WHY IT WOULD BE
UNIQUE TO THIS.
I DON'T DO THIS, FOR THOSE
INVOLVED IN ADMINISTRATION OF
GRANTS I ASSUME IT WOULD BE
DEALT WITH IN THE SAME WAY.
IS THAT A REASONABLE ASSUMPTION?
>> I THINK IT IS.
>> NEXT SECTION WAS BEST
PRACTICES.
IN THIS WE DO HAVE A SECTION ON
THE VARIOUS BEST PRACTICES BUT
ONE OF THE THINGS THE
SUBCOMMITTEE STRUGGLED WITH WAS,
YOU KNOW, LOOKING AT THEM IN
ISOLATION VERSUS LOOKING AT THEM
AS A BUNDLED SET OF BEST
PRACTICES BECAUSE GUIDANCE
DOCUMENT ITSELF SAYS THESE ARE
MEANT TO ALL WORK TOGETHER TO
ENCOURAGE BEST PRACTICES, BUT WE
COULDN'T HELP BUT LOOKING AT
THEM ON SORT OF A POINT-BY-POINT
BASIS.
I THINK THAT JUST HAS TO BE KEPT
IN MIND WHEN LOOKING AT THE
PROPOSED COMMENTS ON EACH BEST
PRACTICE, BUT WE COULDN'T COME
UP WITH A GOOD WAY TO SORT OF
TAKE OUR POINT-BY-POINT PIECES
AND PACKAGE THEM AS AN
OVERARCHING BULK RECOMMENDATION
ABOUT THEM.
WE MIGHT HAVE WITH MORE TIME BUT
THIS WAS A -- WE DIDN'T HAVE AS
MUCH TIME AS USUAL WITH THE PREP
OF THIS DOCUMENT.
FIRST BEST PRACTICE ENSURING
APPROPRIATE DE-IDENTIFICATION
AND WE START OFF BY, AGAIN,
NOTING THAT THE DOCUMENT ITSELF
WHEN IT TALKS IN THIS SECTION
THEY EXPLICITTY CITE COMMON RULE
AND HIPAA AS STANDARDS FOR
IDENTIFIABLE, ANOTHER PLACE
WHETHER WE NOTED, ONE, THERE'S
DIFFERENCES BETWEEN THE TWO, AND
IT'S NOT CLEAR WHETHER THE NIH
EXPECTS BOTH TO BE FOLLOWED
REGARDLESS OF APPLICABILITY, AND
THE PREVIOUS NOTE THAT WAS
MENTIONED THAT THE DEFINITION
WITHIN THE COMMON RULE IS
SUBJECT TO REEVALUATION AND
POSSIBLY CHANGE.
SO THAT'S THE FIRST PARAGRAPH.
THE SECOND PARAGRAPH TALKS ABOUT
IDENTIFYING, YOU KNOW, WOULD BE
HELPFUL TO IDENTIFY CURRENT BEST
PRACTICES OR LINK TO RELEVANT
RESOURCES, FOR THE RESEARCH
COMMUNITY, AND THAT THE NIH
SHOULD CLARIFY WHO HAS THE
RESPONSIBILITY FOR EVALUATING
ADEQUACY OF METHODS EMPLOYED BY
DATA HOLDERS.
AND THEN WE NOTE IF
RE-IDENTIFICATION IS POSSIBLE
ANY INFORMATION REGARDING DATA
SHARING PROVIDED TO PARTICIPANTS
SHOULD INCLUDE INFORMATION ABOUT
THE POSSIBILITY OF
RE-IDENTIFICATION.
AND THERE'S A SENTENCE IN THE
SECTION THAT WE RECOMMENDED
DELETING, THAT STATES IN THOSE
CASES DATA SHARING MAY BE
SUBJECT TO PARTICULAR RULES AND
RESEARCHERS SHOULD ALSO CONSIDER
WHETHER OTHER RELEVANT
PROTECTION SHOULD BE EMPLOYED.
WE RECOMMENDED TAKING THAT OUT
OF THE GUIDANCE.
LOIS THIS GETS TO YOUR IDEA, THE
THEME OF DOES THE NIH SAY WHO
DOES THIS OR THAT IT'S AN
INSTITUTIONAL -- INSTITUTIONS
HAVE REQUIREMENTS TO DO THIS AND
THEY CAN FIGURE IT OUT, THEY
JUST HAVE TO DO IT.
WE'LL MAKE SURE WE'VE USED
CONSISTENTLY LANGUAGE ALONG
THOSE LINES AT EACH OF THE
PLACES WE'VE MADE THAT COMMENT.
>> WALTER?
>> STANDARDS FOR
DE-IDENTIFICATION ARE A BIT OF A
MOVING TARGET, AND SO THERE
MIGHT BE A STATEMENT IN THE --
IN THE DOCUMENT INDICATING THIS
IS FLUID TO CURRENT STANDARDS
ONE COULD REFERENCE THESE ARE
EVOLVEING
>> WALTER, IS THAT SOMETHING YOU
SEE FALLING HERE OR IS IT MORE
BACKGROUND IN THE BEGINNING OF
THE DOCUMENT WHEN IT'S
ESTABLISHING THE LANDSCAPE?
WE'VE TALKED ABOUT, FOR EXAMPLE,
ALTERNATE COLLECTION METHODS,
MOVING IT TO THE FRONT.
>> I'M AGNOSTIC ON IT, DAVID.
>> LET'S PUT A NOTE HERE IN
MYSELF.
>> ANOTHER BEST PRACTICE
ESTABLISHING SCIENTIFIC DATA
SHARING AND USE AGREEMENTS.
YOU KNOW, PERHAPS OBVIOUSLY THIS
IS ONE OF THE AREAS WHERE WE
SAID, WELL, IF IT'S A GREAT IDEA
PERHAPS THE NIH SHOULD COME UP
WITH ONE THAT INCLUDES
EVERYTHING THAT'S REQUIRED BY
THE POLICY.
AND THEN THIS BEST PRACTICE ALSO
TALKS ABOUT THAT THE AGREEMENT
SHOULD CLEARLY INCLUDE
CERTIFICATION FROM INSTITUTIONAL
OFFICIAL.
AND A NUMBER OF SUBCOMMITTEE
MEMBERS WERE CONCERNED THAT
CERTIFICATION HAS A LOT OF
IMPLICATIONS IN TERMS OF WHAT
SOMEBODY'S DOING AND IF IT'S
REALLY A REQUIREMENT, IT
SHOULDN'T BE CALLED OUT AS A
BEST PRACTICE, IT SHOULD BE
IDENTIFIED AS A REQUIREMENT
EITHER WITHIN THE POLICY OR IN
THE GUIDANCE ON IMPLEMENTING THE
POLICY OR IN CONTEXT OF A
STANDARDIZED AGREEMENT.
WE WEREN'T SURE HOW THAT FIT IN
AS A BEST PRACTICE.
.
OKAY.
AND THE LAST BEST PRACTICE --
SORRY, SKIP.
>> MIGHT BE A TYPO IN THE LAST
SENTENCE BUT SACHRP RECOMMENDS
NIH WILL REQUIRE CERTIFICATION
THAT THIS BE INCLUDED OR THAT IT
BE INCLUDED?
EITHER THIS OR IT.
>> YEAH.
>> WHEN YOU GO TO THE FIRST PAGE
YOU TALK ABOUT THIS CONCEPT OF
CERTIFICATION, INSTITUTIONAL
CERTIFICATION, AND I'M TRYING TO
FIND IT.
>> IT MIGHT BE IN THE, YEAH,
AROUND LINE 33.
>> INSTITUTIONAL CERTIFICATION
ACTION THAT SHOULD ONLY BE
RAISED AS A REQUIREMENT NOT AS
ASPIRATIONAL GOAL.
OKAY.
THEN I GUESS YOU'RE CORRECT.
LATER ON YOU SAY THE SAME THING.
MY ONLY QUESTION IS, MAYBE IT
MAKES SENSE THE INSTITUTIONAL
OFFICIAL OR DESIGNEE, ARE YOU
ASSUMING IT HAS TO BE -- ARE YOU
DIRECTING TO INSTITUTIONAL
OFFICIAL OR IS IT -- IS THERE
SOME LATITUDE THERE THAT IS
GIVEN THERE?
WHAT ARE YOUR THOUGHTS AND
PRACTICE HOW THAT WOULD WORK?
COULD THAT BE DELEGATED?
I JUST DON'T REMEMBER.
I KNOW WE TALKED ABOUT THAT.
>> WE TALKED ABOUT IT.
AS SOMEONE WHO DOES NOT DO
RESEARCH ADMINISTRATION, YOU
KNOW, I SUSPECT THAT THE
SUBCOMMITTEE WOULD SAY THAT, YOU
KNOW, ABSENT A VERY SPECIFIC
REQUIREMENT IN THE POLICY, THAT
INSTITUTIONS SHOULD HAVE
FLEXIBILITY IN DECIDING HOW TO
DO THAT.
>> I WANT TO SAY ON LINE 33,
DESCRIBES AN INSTITUTIONAL
CERTIFICATION AND ACTION THAT
SHOULD ONLY -- OKAY, THAT PART I
SEE BUT WE USE THE WORD
INSTITUTIONAL OFFICIAL LATER.
>> I CAN'T REMEMBER.
>> IF YOU COULD TAKE A LOOK TO
SEE WHETHER YOU INTENDED IT TO
BE VERY SPECIFIC OR DID YOU JUST
MEAN INSTITUTIONAL, WITHOUT THE
OFFICIAL SIFICATION, THAT'S THE
QUESTION I HAVE.
>> WE DECIDED NOT TO USE IT.
>> IT'S IN THE QUOTE.
LINE 138, IT'S IN THE QUOTE.
IT'S THE NIH, ASSUMING THAT'S A
QUOTE FROM THE NIH.
THAT'S WHERE THERE'S AMBIGUITY.
YOU COULD ADD THAT POINT.
IT DOESN'T HAVE TO BE THE
INSTITUTION FOR SURE.
>> BASICALLY CLARIFY WHAT YOU
DID ON LINE 33.
THANK YOU.
>> YEAH, THAT ALSO FITS IN WITH
LOIS' THEME OF PUTTING THAT
RESPONSIBILITY BACK ON THE
INSTITUTION TO FIGURE OUT HOW TO
COMPLY AND USING -- WHICH
INSTITUTIONAL MECHANISMS TO USE
TO BE COMPLIANT, YEAH.
ALL RIGHT.
LAST BEST PRACTICE IS
UNDERSTANDING LEGAL PROTECTION
AGAINST DISCLOSURE AND MISUSE.
A FOCUS OF THIS ONE WAS
CERTIFICATES OF CONFIDENTIALITY.
SOME OF THE SUBCOMMITTEE MEMBERS
WERE CONCERNED IT MADE IT SOUND
LIKE THAT WAS THE ONLY LEGAL
PROTECTIONS AGAINST DISCLOSURE
MISUSE.
WHERE CLEARLY IT ISN'T.
THERE ARE RELEVANT LAWS SUCH AS
HIPAA BUT STATE LAWS MY APPLY
LIMITATIONS ON RESEARCHERS, IT'S
A POINT OF CONCERN, GUIDANCE
MAKE IT SOUND LIKE ALL YOU HAD
TO WORRY ABOUT WERE CERTIFICATES
OF CONFIDENTIALITY, AND IN IF
THAT'S THE FOCUS THE PARAGRAPH
AT 146 WE WOULD SAY THAT THEN
MAKE IT A BEST PRACTICE THAT'S
CLEARLY ABOUT THAT AND RENAME IT
SOMETHING LIKE COMMUNICATE
PROTECTIONS AFFORDED BY
CERTIFICATE, FOCUSED ON THAT AND
CLEAR THE FOCUS IS ON THAT
PARTICULAR ONE, AND, YOU KNOW,
CERTAINLY COULD BE A PLACE WHERE
OTHER ONES ARE MENTIONED BUT OUR
FEELING WAS THE INTENT OF NIH
WAS TO ESSENTIALLY REMIND THE
COMMUNITY ABOUT CERTIFICATES OF
CONFIDENTIALITY AND TO MAKE SURE
THEY ARE APPROPRIATELY
COMMUNICATED.
THE THIRD SECTION OF THE
DOCUMENT WAS POINTS TO CONSIDER.
AND WE DIDN'T HAVE A LOT OF
COMMENTS THERE BUT WE DID
RECOMMEND THE NIH INCLUDE
EXAMPLES OF ACCESS CONTROL
MEASURES THAT WOULD BE
ACCEPTABLE TO THE NIH AND
CLARIFY HOW COMPLIANCE WITH ANY
LIMITATIONS OR PROHIBITIONS
WOULD BE MONITORED.
AND IN THE FOURTH POINT TO
CONSIDER, WE WANTED TO ADD THE
PHRASE, APPROACHES THAT BECOME
KNOWN, AFTER A PHRASE THAT
CURRENTLY READS PREVIOUSLY
UNANTICIPATED APPROACHES.
AND THEN FINALLY IT'S NOT CLEAR
WHO IS EXPECTED TO COMMUNICATE
NECESSARY CHANGES TO THE DATA
MANAGEMENT SHARING PLANS TO THE
NIH OR HOW NEW INFORMATION
SHOULD BE COMMUNICATED, THAT MAY
FALL BACK ON SKIP'S COMMENT THIS
IS PART OF THE ACTIVITIES OF
OBTAINING AND MAINTAINING A
GRANT, AND SO, YOU KNOW, IT MAY
BE ALREADY BUILT INTO THE SYSTEM
THAT THIS IS GOING TO HAPPEN.
BUT THIS IS WHERE WE LANDED AS
THE SUBCOMMITTEE.
>> AGAIN, ANOTHER TYPO, THE
PHRASE APPROACHES HAVE BECOME
KNOWN, IS THAT SUPPOSED TO BE
SIMPLY THAT BECOME KNOWN?
TAKE APPROACHES OUT OF THE QUOTE
BECAUSE YOU DON'T WANT TO READ
PREVIOUSLY UNANTICIPATED
APPROACHES THAT BECOME KNOWN,
RIGHT?
PREVIOUSLY UNANTICIPATED
APPROACHES THAT BECOME KNOWN.
FIRST LINE OF 158.
>> I'M LOOKING AND TRYING TO
REMEMBER.
I DON'T HAVE THE GUIDANCE
DOCUMENT SO I CAN'T LOOK BACK
AND SEE WHAT THE CURRENT
LANGUAGE IS.
BUT I WILL PUT A NOTE IN THERE.
>> DOUBLE CHECK.
IT LOOKS LIKE YOU HAVE APPROACH
APPROACH AFTER EACH OTHER.
>> RIGHT.
AND I DON'T REMEMBER WHY WE
THOUGHT PREVIOUSLY UNANTICIPATED
APPROACHES DIDN'T -- MIGHT HAVE
BEEN UNANTICIPATED BUT IF THEY
ARE NOW KNOWN THEY HAVE BECOME
KNOWN.
I'LL TAKE A LOOK AT THAT.
WHEN I DO THAT I'LL LOOK AT THE
GUIDANCE DOCUMENT ITSELF SO THAT
I CAN TRY TO REMEMBER WHAT LED
TO THAT.
THE CONCLUSION IS
STRAIGHTFORWARD.
IT MIGHT BE A PLACE TO SORT OF
PUT AN EXPLANATION POINT OR FINE
POINT ON LOIS' THEME OF, YOU
KNOW, NIH SHOULD BASICALLY TELL
INSTITUTIONS TO DO WHAT THEY ARE
SUPPOSED TO DO.
I'VE GOT A FEW - SOME LANGUAGE
TO CLEAN UP.
I'LL WORK ON GOING THROUGH AND
PUTTING IN THE CHANGES TO THE
INSTITUTIONAL COMPONENT LANGUAGE
THAT WE'VE DISCUSSED.
AND CAN BRING IT BACK TOMORROW
FOR A QUICK REVIEW.
AND LOIS, I MIGHT RUN THE
LANGUAGE BY YOU BY E-MAIL BEFORE
JUST TO -- SO IT MAKES SENSE TO
SOMEBODY BESIDES ME.
WE'RE AHEAD OF SCHEDULE, JULIA,
BUT THAT'S IT FOR THIS.
>> ANYTHING ELSE FROM COMMITTEE
MEMBERS?
IF HE MAKES THOSE CHANGES WE'RE
READY TO MOVE FORWARD WITH IT.
ALL RIGHT.
THANKS, DAVID.
>> THANKS TO ALL OF YOU.
>> SO YOU'RE GOING TO MAKE THOSE
CHANGES AND BRING IT BACK?
>> YEAH.
>> TODAY OR TOMORROW?
>> I WILL MAKE THE CHANGES THIS
EVENING, BRING THEM BACK
TOMORROW.
>> OKAY.
>> CAN YOU TELL ME HOW I CAN GET
THIS TRACK DOCUMENT?
>> I WILL WORK ON IT.
>> THAT'S FINE.
OKAY.
>> MAKE SURE IT'S SAVED.
>> I JUST CLICKED THE SAVE
BUTTON.
>> OKAY, OKAY.
>> I'M GOING TO LEAVE THE PODIUM
THEN.
>> OKAY.
>> MICHAEL, ARE YOU READY TO GO
EARLY?
>> YES, SIR.
>> THE LAST OFFICIAL ITEM IS AN
UPDATE FROM THE OHRP DIVISION OF
EDUCATION.
YVONNE IS NOT HERE BUT MICHAEL
GRIPALDI AGREED TO DO THIS.
WELCOME, MICHAEL.
>> GOOD AFTERNOON.
AS WAS MENTIONED, UNFORTUNATELY
YVONNE COULDN'T BE HERE, DR.
YVONNE LAU, SHE'S UNDER THE
WEATHER SO I'M GOING TO DO MY
BEST TO FILL IN FOR HER AND TALK
LOUDLY.
UNFORTUNATELY, BEING TALL IS
DIFFICULT AT THIS TIME SO I'LL
DO MY BEST TO PROJECT.
I'M HERE TO TALK ABOUT UPCOMING
EVENTS THAT OHRP IS GOING TO BE
HAVING.
IN SEPTEMBER ON THE 15th
HOSTING OUR FIFTH ANNUAL
EXPLORATORY WORKSHOP, BEYOND AL
ALTRUISM, EXPLORING PAYMENT, A
TOPIC SACHRP TOOK ON A FEW YEARS
AGO SO WE'RE BRINGING IT BACK.
IT'S TWO-SESSION, FREE
LIVESTREAMING EVENT.
FIRST SESSION WILL CONSIST OF
MORE OF THE ETHICAL AND
THEORETICAL FRAMEWORKS OF PAYING
PARTICIPANTS, WE'LL HAVE
SESSIONS INTRODUCING THE TOPIC,
TALKING ABOUT USING PAYMENT AS A
FORM TO ADVANCE JUSTICE, EQUITY,
INCLUSION.
WE'LL HAVE A SESSION ON IRB
PERSPECTIVES AND RESEARCHER
PERSPECTIVES, AS TO POSSIBLE
RELUCTANCE WHY THEY ARE DOING
THIS.
WE'LL HAVE PARTICIPANT
PERSPECTIVES, THREE RESEARCHERS
DISCUSSING RESEARCH THAT THEY
HAVE DONE WITH POPULATIONS AND
HOW THEY FEEL, WHAT THEIR
CONTRIBUTIONS ARE.
AND ONE OF WHICH IS A GROUP IN
NORTHERN PHILADELPHIA.
>> I'M SORRY, WE'RE NOT SEEING
YOUR SLIDES.
WE'RE STILL SEEING THE PREVIOUS
DOCUMENT IN THE ZOOM.
>> HOW ABOUT NOW, JANET?
>> YES, THANK YOU.
>> APOLOGIES.
AND SO THEN WE'LL -- THERE'S A
RESEARCHER TALKING ABOUT THEIR
EXPERIENCE WORKING WITH AN
HIV-POSITIVE POPULATION, ALSO
USES DRUGS AND HOW THEY VIEW
THEIR PARTICIPATION.
THEN BECAUSE PHASE 1 TRIALS ARE
A BIT OF A DIFFERENT BEAST
ALTOGETHER WE'RE GOING HAVE A
SPEAKER TALK ABOUT MOTIVATION
FOR PARTICIPATING IN PHASE 1
WHICH PRIMARILY SOMETIMES IS THE
MONEY.
AND WHAT KEEPS THEM COMING BACK.
THEN ALSO WITH KIND ECONOMY,
MANY PEOPLE HAVE MULTIPLE JOBS,
DOING UBER AND DOOR DASH AND
PARTICIPATING IN RESEARCH, DO
THEY DESERVE MORE RIGHTS,
POSSIBLY EMPLOYMENT RIGHTS,
THINGS LIKE THAT.
WHAT MAKES TH EXPLORATORY
WORKSHOP UNIQUE, EACH SESSION IS
15 MINUTES WITH 45-MINUTE
MODERATED DISCUSSION, AN
OPPORTUNITY FOR PANELISTS TO GET
TOGETHER AND DISCUSS THESE
ISSUES, WITH QUESTIONS THROWN
OUT.
THE AFTERNOON SESSION IS MORE
ABOUT THE PRACTICALITY OF
PAYING.
SO WE'LL HAVE DISCUSSIONS ABOUT
WHETHER IT REALLY IS JUST
SEMANTICS FOR PARTICIPANTS,
WHETHER WE CALL IT REIMBURSEMENT
OR WHETHER IT IS PAYMENT OR IF
IT'S COMPENSATION.
ALSO TALK ABOUT LOGISTICS OF
PAYING.
SOMETIMES IT CAN BE A BIT OF A
HINDRANCE FOR SOMEONE TO RECEIVE
A CHECK IF THEY DON'T HAVE A
CHECKING ACCOUNT.
ALSO IF YOU HAVE TO DISCLOSE
YOUR SOCIAL SECURITY NUMBER,
MAYBE THAT'S SOMETHING YOU'RE
CONCERNED ABOUT.
WE'LL ALSO HAVE A SPEAKER
TALKING ABOUT SOCIAL BEHAVIORAL
AND EDUCATION RESEARCH,
SOMETIMES PRESENT UNIQUE ISSUES
DOING ONLINE RESEARCH AND IT'S
ANONYMOUS.
WE'LL HAVE PEOPLE WHO HAVE GONE
THROUGH AND DONE THIS TYPE OF
WORK DISCUSSING THINGS.
WE'LL ALSO HAVE A CONCLUSION
TALKING ABOUT IS PAYMENT REALLY
THE SILVER BULLET FOR HAVING AN
INCREASE IN DIVERSITY, EQUITY,
AND INCLUSION IN RESEARCH.
AGAIN, THE SESSIONS, IT'S A
FREEZE-FRAMING ONE DAY FROM 10
TO 4, A UNIQUE OPPORTUNITY TO
HAVE EXPERTS COME IN, GIVE THEIR
SPIEL AND HAVE A GROUP
DISCUSSION.
WE'RE PARTICULARLY EXCITED ABOUT
THIS.
FIFTH ANNUAL ONE, IF YOU
ATTENDED THE PREVIOUS ONES THEY
ARE PRETTY GOOD.
YOU LEAVE AWAY WITH A LOT OF
FOOD FOR THOUGHT.
SO, WE HAVE SOMETHING THAT'S
CALLED RESEARCH COMMUNITY FORUM.
AND FOR THE LAST FEW YEARS
BECAUSE OF THE PANDEMIC THESE
HAVE ALL BEEN VIRTUAL.
WE HAD ONE WITH NORTHWELL HEALTH
IN MAY, LOOKING FORWARD TO
RETURNING TO IN-PERSON EVENTS.
THE FIRST ONE IS ABOUT A WEEK
AFTER THE WORKSHOP, IT'S THE
20th AND 21st IN INDIANA,
PARTNERING WITH INDIANA
UNIVERSITY.
AND IT'S CALLED NEW FRONTIERS IN
HUMAN SUBJECTS RESEARCH.
SO DAY 1 CONSISTS OF A WORKSHOP,
OHRP-LED EVENTS.
WE'LL BE CONDUCTING CASE STUDIES
AND HAVING AUDIENCE INTERACTION
ASKING YOU TO MAKE JUDGMENTS
ABOUT THINGS, APPLY REGULATIONS,
A SESSION TALKING ABOUT USING
COMMUNITY ENGAGEMENT RESOURCES,
HOW WE CAN USE THOSE.
AGAIN, EVERYTHING ON THE WEBSITE
IS FREE.
I'LL GET MORE INTO THAT LATER.
BUT WE'RE HERE FOR THE
POPULATION.
>> COULD YOU PUT YOUR SLIDES IN
PRESENTATION?
>> PRESENTATION MODE.
>> I'LL DO IT.
>> THERE WE GO.
THANK YOU.
>> ALL RIGHT, SECOND APOLOGIES.
AND THEN WE'LL HAVE, AGAIN, THIS
IS DAY OF THE WORKSHOP, INDIANA
UNIVERSITY.
WE'LL TALK ABOUT HOW TO USE HRPP
RESOURCES EQUITABLY, DON'T WANT
TO BE USING A LOT OF MONEY OR
TIME ON SOMETHING THAT'S NOT
NECESSARILY WORTH IT, KIND OF
HOW TO USE THEM, LOW-HANGING
FRUIT.
DAY 1 IS A WORKSHOP, MEANT FOR
PEOPLE WORKING IN THE IRB
OFFICE, HRPP PROFESSIONALS,
PEOPLE LIKE THAT.
DAY 2, OH, IN THE AFTERNOON, IN
THE MORNING WE'LL TALK --
COLLECT IDEAS FROM THE AUDIENCE
ABOUT THINGS THAT PEOPLE ARE
LOOKING FORWARD TO TALKING
ABOUT, MAYBE PROBLEMS THEY HAVE
RUN INTO AND HOW THEY SOLVE
THEM.
WE'LL COLLECT IDEAS IN THE
MORNING AND THEN IN THE
AFTERNOON WE'LL HAVE A
DISCUSSION WHERE IT'S
REGULATORILY APPLICABLE, A
UNIQUE OPPORTUNITY FOR HRPP
OFFICES AND IRB OFFICES TO HELP
EACH OTHER OUT.
ODDS ARE IF YOU'VE SEEN
SOMETHING, SOMETHING ELSE WILL
SEE IT SOON OR THEY HAVE ALREADY
SEEN IT.
OOPS.
SO, DAY 2 IS THE ACTUAL
CONFERENCE.
SO THE KEYNOTE LEADS OFF TALKING
ABOUT PERSPECTIVES FROM THE VICE
PRESIDENT OF RESEARCH OFFICES.
WHEN IMPLEMENTING NEW COMPLIANCE
IDEAS WHO IS IN CHARGE, IRB,
INSTITUTIONAL LEVEL, OR SOMEONE
LOWER LIKE THE RESEARCHER
THEMSELVES?
A TALK ABOUT NEW CHALLENGES FOR
THE IRB THAT THEY ARE FACING AS
FAR AS GLOBAL RESEARCH.
ALSO RETURNING RESULTS,
NAVIGATING SINGLE IRB IF IT IS
DOMESTIC, THINGS LIKE THAT.
IT'S WE'LL HAVE A SESSION ABOUT
OPPORTUNITIES FOR IRB TO PROMOTE
DIVERSITY, EQUITY, AND
INCLUSION.
IN THE AFTERNOON THERE'S, AGAIN,
IT'S RESEARCH AND NEW FRONTIERS,
A SESSION ON ARTIFICIAL
INTELLIGENCE RESEARCH FROM
RESEARCHER AND JUST THE
CHALLENGES THAT THEY FACE AS
WELL AS HOW THEY HAVE SOLVED
SOME OF THIS.
THERE'S GOING TO BE ENSURING
RESEARCH INTEGRITY ONLINE
SESSION, AS WELL AS HOW THE IRB
CAN KIND OF GO FORWARD WITH DATA
SHARING.
WE WANT TO BE ABLE THAT THIS
IS -- THAT WE'RE SHARING THE
DATA THAT WE HAVE WITH OTHER
RESEARCHERS SO THEY CAN USE IT,
ALSO MAINTAINING PRIVACY AND
CONFIDENTIALITY OF THE SUBJECTS
WHO CONTRIBUTE TO THE RESEARCH.
LASTLY, AT THE END OF THE DAY
THERE'S GOING TO BE A SESSION
TALKING ABOUT WORKING WITH
SPONSORS.
OFTENTIMES A LOCAL SITE MIGHT
HAVE A CONFLICT WITH A SPONSOR'S
DOCUMENT, HOW TO NAVIGATE THAT
REALM.
AND THEN WE'RE ACTUALLY HAVING A
SECOND IN-PERSON RCF IN RENO,
NEVADA, AT THE END OF OCTOBER,
25TH TO 26th.
SIERRA NEVADA MOUNTAINS ARE IN
THE BACKGROUND, IT'S CLOSE TO
LAKE TAHOE WHICH I'VE BEEN TO,
IT'S ABSOLUTELY GORGEOUS.
IT REALLY IS AN OUTDOORS
PARADISE, IF YOU LIKE HIKING,
THE TRUCKEE RIVER I BELIEVE RUNS
RIGHT THROUGH THE TOWN.
IT'S A BEAUTIFUL LOCATION.
IT'S AT THE END OF OCTOBER.
IF YOU'RE AN EAST COAST PERSON
IT COULD BE NICE TO ESCAPE THE
COLD AND GO OUT TO SOME OF THE
WARMTH.
KEEPING WITH THE TWO-DAY FORMAT,
FIRST DAY IS THE WORKSHOP DAY,
SO A LOT OF OHRP-LED EVENTS.
WE'LL HAVE THE CASE STUDY.
WE'RE ALSO GOING TO BE TALKING
ABOUT RESEARCH WITH INDIVIDUALS
WHO HAD REDUCED FREEDOMS.
THERE'S ALSO GOING TO BE FROM
ONE OF THE CO-HOSTS DISCUSSION
ON MITIGATING RISK OF VULNERABLE
POPULATIONS.
THE NAME OF THE CONFERENCE WHICH
I SHOULD HAVE SAID EARLIER IS
TRUST TECHNOLOGY AND CONSENT.
YOU'LL SEE THE THREE THEMES
RUNNING THROUGHOUT.
DAY 2, AGAIN, IS THE ACTUAL
CONFERENCE WHERE THIS IS MORE
APPLICABLE TO RESEARCHERS AND
IRB MEMBERS, BASICALLY ANYONE IN
THE COMMUNITY.
IT'S GOING TO BE LED OFF BY
KEYNOTE TALKING ABOUT BUILDING
TRUST, INFRASTRUCTURE, WITH
PERVASIVE DIGITAL DEVICES.
OFTENTIMES SOMEONE MIGHT NOT
EVEN BE AWARE THEIR DATA IS
BEING COLLECTED SO IT'S KIND OF
TAKING A LOOK AT HOW AS A
RESEARCHER LESSONS THEY HAVE
LEARNED AND ALSO PROVIDING IRB
PERSPECTIVES ON HOW YOU CAN
BUILD TRUST WITH THIS COMMUNITY.
ANOTHER PARTNER WITH UNIVERSITY
OF NEVADA IN RENO IS THE
UNIVERSITY OF CALIFORNIA AT
DAVIS.
THEY ARE GOING TO BE HAVING A
SESSION TALKING ABOUT HOW THEY
HAVE SUCCESSFULLY PAIRED WITH
SOME COMMUNITY INSTITUTIONS SO
THEY PAIRED RESEARCHERS AND HAVE
BEEN ABLE TO GO OUT AND GET THE
COMMUNITY ONBOARD, AGAIN
BUILDING TRUST.
WE'LL HAVE AN OHRP SESSION.
DR. YVONNE LAU, OPPORTUNITIES
UNDER THE COMMON RULE.
SO THEN TURNING TO THE AFTERNOON
THERE'S GOING TO BE A TALK, ONE
OF THE HIGHLIGHTS ON MOBILE
APPS, CONNECTED DEVICES, WHAT
REGULATIONS CURRENTLY EXIST,
WHAT KIND OF OVERSIGHT IS THERE
FOR THESE TYPES OF DEVICES AND
HOW THAT DOVETAILS WITH THE
RESEARCH.
AS WELL AS IRB PERSPECTIVES ON
HOW TO COVER AND REVIEW RESEARCH
LIKE THIS.
SOMETHING I THINK THAT'S
PARTICULARLY INTERESTING,
THERE'S GOING TO BE A SESSION ON
USING VIRTUAL REALITY TO HELP
PAIN MANAGEMENT WITH VETERANS.
I THINK THAT'S SUCH A UNIQUE
THING THAT I'M INTERESTED IN
ATTENDING.
TO CLOSE OFF THE DAY THERE WILL
BE DISCUSSION ON RESEARCH WITH
BORDER AND REFUGEE POPULATIONS,
JUST IRB CONSIDERATIONS FOR
MAKING SURE THAT PRIVACY IS
PROTECTED, AS WELL AS INCLUDING
THEM IN THE RESEARCH.
SO, I THINK IT MIGHT HAVE BEEN
JERRY EARLIER MENTIONED BEING
HARD AT WORK PRODUCING RESOURCES
SO I'LL HIGHLIGHT A CUP THE
THINGS.
CREATED THIS ONE SHEET BIFOLD,
ALSO A POSTER THAT TALKS IN
PLAIN LANGUAGE ABOUT WHAT
RESEARCH IS, HOW RESEARCH WORKS.
ALSO QUESTIONS FOR POTENTIAL
PARTICIPANTS TO ASK SUCH AS
WHAT'S GOING TO HAPPEN IN THE
RESEARCH, WHY ARE YOU DOING THE
RESEARCH?
THIS IS SOMETHING THAT
INSTITUTIONS CAN HAVE AND
DISTRIBUTE, EITHER AS I
MENTIONED AS A ONE SHEET, FRONT
AND BACK, OR BIFOLD, AND 11 X 17
POSTER.
THIS IS ON OUR WEBSITE.
IT'S FREE, ALL OF OUR RESOURCES
ARE FREE, WE IMPLORE YOU TO USE
AND SPREAD THEM.
IT'S GOOD FOR GENERAL PUBLIC TO
JUST INTRALEVEL WHAT IS
RESEARCH, WHY ARE YOU TALKING TO
ME AND HOW IF I AM INTERESTED
HOW DO I FIGURE OUT THE NEXT
STEPS.
THIS IS AVAILABLE IN SPANISH.
A LOT OF RESOURCES HAVE BEEN
TRANSLATED INTO SPANISH.
WE ALSO CREATED A RESOURCE FOR
COMMUNITY MEMBERS CHECK LIST.
SO AS FAR AS SOME OF THE THEMES
TALKING ABOUT COMMUNITY
ENGAGEMENT THIS IS SOMETHING
THAT YOU CAN USE TO WORK WITH
EITHER PEOPLE WHO ARE INTERESTED
IN RESEARCH OR POSSIBLY THAT
COMMUNITY MEMBER.
STARTS AT BASIC LEVEL, AS I
MENTIONED USING THE PREVIOUS
RESOURCE THAT WE'VE CREATED TO
INTRODUCE WHAT RESEARCH IS, GOES
THROUGH SOME PREVIOUSLY CREATED
DOCUMENTS, WHICH USE
INFOGRAPHICS TO WALK THROUGH THE
GENERAL PUBLIC, SOME RESEARCH
TERMS.
AND ALSO TALKS ABOUT LIKE WHAT
IS MEDICAL RESEARCH, HOW IS THIS
DIFFERENT FROM SOCIAL BEHAVIORAL
RESEARCH.
THIS IS SOMETHING THAT CAN BE
USED TO ENGAGE PEOPLE THAT ARE
INTERESTED IN RESEARCH, AS WELL
AS IF YOU'RE INTERESTED IN
GETTING THAT NEW PERSON ONTO
YOUR IRB.
WE HAVE RECENTLY UPDATED ANOTHER
CHECK LIST THAT IS FOR PEOPLE
WHO ARE WORKING WITH IRBs, SO
THIS IS A LITTLE MORE DETAILED.
WE DO GET INTO MORE OF THE
REGULATIONS AND MORE OF WHILE
THIS DOES COVER SOME HISTORY
LIKE THE BELMONT REPORT, BUT THE
ONE FOR PEOPLE WORKING WITH
IRBs DOES GET MORE INTO THE
REGULATIONS AND COVERS SOME
GUIDANCE.
IT'S ACTUALLY A GOOD TRAINING
DOCUMENT THAT YOU GO THROUGH AT
YOUR SPEED IN THE ORDER WE
LISTED, A GREAT REVIEW FOR
ANYONE WHO IS INTERESTED IN
BONING UP ON PREVIOUS THINGS
THAT PERHAPS THAT THEY HAVE
FORGOTTEN BECAUSE THEY DON'T
FREQUENTLY REVIEW THAT TYPE OF
RESEARCH, NOT DOING PART C OR
PART D.
AND SO WE HAVE OUR ABOUT
PARTICIPATION BRANDED MATERIALS.
THIS IS AS I MENTIONED LIKE
BASIC LEVEL THINGS FOR
INTERACTING WITH THE GENERAL
PUBLIC AND THE COMMUNITY.
I BELIEVE ALL OF THEM HAVE BEEN
TRANSLATED, IF NOT ALL MOST HAVE
BEEN TRANSLATED INTO SPANISH SO
THAT'S A GREAT RESOURCE TO REACH
OUT TO AN ADDITIONAL GROUP
THAT'S INTERESTED IN LEARNING
ABOUT RESEARCH OR HAS QUESTIONS
ABOUT RESEARCH.
WE DO HAVE SOMETHING THAT CAN BE
PRINTED OFF, QUESTIONS TO BRING
WHEN YOU'RE HAVING INFORMED
CONSENT DONE, POTENTIAL
PARTICIPANT CAN WALK THROUGH
QUESTIONS.
A LOT OF US HAVE THAT WHITE COAT
NERVOUSNESS, ALSO TRANSLATES TO
THE GENERAL PUBLIC WHEN THEY ARE
GOING TO PARTICIPATE.
SO IT GIVES THEM THINGS THEY CAN
GO THROUGH AND ASK.
WE ALSO HAVE VIDEOS, RECENTLY
WE'VE POSTED VOICES OF
PARTICIPANT SERIES WHERE OHRP
HAS INTERVIEWED ACTUAL RESEARCH
PARTICIPANTS AND ASKED THEM
ABOUT EXPERIENCES, RESOURCES YOU
CAN SHARE WITHIN YOUR
INSTITUTION, WITHIN YOUR
RESEARCH COMMUNITY, ALSO SHARE
WITH THE PUBLIC.
AGAIN, THEY ARE ALL FREE.
THANK YOU.
>> WE'RE GOING TO TAKE
QUESTIONS.
>> COULD YOU --
>> DON'T ESCAPE SO FAST.
WONDERED IF YOU COULD SPEAK TO
EDUCATIONAL LEVEL WHICH THE
INFORMATION FOR POTENTIAL
RESEARCH PARTICIPANTS IS
TARGETED.
>> WE'VE TRIED OUR BEST.
YOU HEAR EIGHTH GRADE LEVEL.
WE'VE TRIED TO GET THAT DOWN TO
MAYBE SIXTH GRADE LEVEL.
IT'S A COMBINATION OF REALLY
GOING THROUGH AND WE'RE
DELIBERATE WITH OUR WORD CHOICE,
AND WHERE WE CAN USE A SIMPLE
WORD AS OPPOSED TO A TEN DOLLAR
WORD, WE DO.
AND THEN ALSO WE HAVE KIND OF
TESTED THEM WITHIN OUR OWN
GROUP, TAKING RECOMMENDATIONS
FROM OHRP LEADERSHIP AS WELL AS
EVEN SOME OF YOU REVIEWED OUR
DOCUMENTS IN THE PAST.
>> AND THEN AS A FOLLOW-UP,
ESTIMATED APPROXIMATELY HALF THE
POPULATION IS FUNCTIONALLY
ILLITERATE.
AND SO THAT POPULATION IS GOING
TO BE MORE -- GRAVITATE MORE
TOWARDS VIDEOS, AND HAS A
DIFFERENT STRATEGY BEEN TAKEN
FOR VIDEOS THAN FOR THE WRITTEN
MATERIAL?
>> WELL, I THINK WE'VE TRIED TO
BE PRETTY INCLUSIVE KEEPING IT
KIND OF TO A BASIC LEVEL OF
UNDERSTANDING.
AND SO WE DO HAVE VIDEOS AS I
MENTIONED THAT EXPLAIN WHAT IS
RESEARCH.
WE HAVE ONE THAT TALKS ABOUT
RANDOMIZATION, KIND OF THINGS
THAT MIGHT BE -- POSE A BIT OF
AN ISSUE TO SOMEONE WHO IS NEW
TO RESEARCH.
WE ARE CREATING MORE VIDEOS ALL
THE TIME.
IT'S JUST A DIFFERENT WAY TO
DISTRIBUTE THE KNOWLEDGE THAT
WE'RE -- THAT WE'VE TOLD
TOGETHER, AND, YEAH, I WOULDN'T
SAY IT'S NECESSARILY A DIFFERENT
APPROACH, THE SAME APPROACH, WE
UNDERSTAND PEOPLE LEARN IN
DIFFERENT MANNERS SO THAT'S WHY
WE HAVE THE SELF-GUIDED CHECK
LISTS YOU CAN GO THROUGH.
IN THOSE THERE ARE A LOT OF
VIDEOS AS WELL AS THEIR OWN
DOCUMENTS BUT I DO BELIEVE IT IS
MORE IMPORTANT TO HAVE A MORE
INTERACTIVE VIDEO, IF YOU WILL,
FOR SOMEONE WHO IS, YOU KNOW,
NEW TO THE SUBJECT, JUST SO THEY
HAVE THE OPPORTUNITY TO BE
SELF-GUIDED, GUIDED THROUGH THAT
BY THE VIDEO AS OPPOSED TO
READING DOCUMENTS WHICH A LOT OF
PEOPLE CAN BE BORED BY,
REPETITIVE.
>> THANKS.
>> YOU'RE WELCOME.
>> YES?
>> HAS THOUGHT BEEN GIVEN TO
ADDITIONAL LANGUAGES BESIDES
SPANISH?
OR IF IT'S A SITUATION WHERE
SOMEONE LEARNED TO USE A
CHECKLIST OR MATERIALS, THEY
WANTED TO TRANSLATE THAT WOULD
BE PERMISSIBLE, IS THERE A
PROCESS FOR GETTING PERMISSION
TO DO THAT.
>> ALL OF OUR MATERIALS WERE
FULLY DISTRIBUTIVE, LIKE YOU CAN
TAKE IT AND DO WHAT YOU WOULD
LIKE WITH IT.
AT THIS TIME I DON'T BELIEVE WE
HAVE PLANS TO TRANSLATE INTO
OTHER LANGUAGES BUT IF AN
INSTITUTION WANTS TO TAKE THAT
ON CERTAINLY I KNOW THERE'S
HUBS, IF YOU WILL, IN DIFFERENT
CITIES WHERE THEY SPEAK
DIFFERENT LANGUAGES, MIGHT
BEHOOVE THEM TO DO THAT.
>> THAT'S PERMISSIBLE.
>> YEAH, RIGHT.
>> THANK YOU.
>> YOU'RE WELCOME.
>> WE HAVE A QUESTION IN THE
ZOOM ROOM.
>> YES.
>> HI.
I WANTED TO CLARIFY, IS THERE
TRAINING OR ARE THERE MATERIALS
AVAILABLE THAT COULD BE USED
TO -- AS ALTERNATIVE TO
TYPICALLY TRAINING FOR COMMUNITY
RESEARCHERS?
>> SO, WE DO HAVE A FIVE-PART
HUMAN RESEARCH PROTECTION
FUNDAMENTAL SERIES THAT IS FREE.
IT'S PRETTY THOROUGH.
IT COULD BE USED INSTEAD OF
CITY, BUT I THINK INSTITUTIONS
HAVE THEIR OWN REQUIREMENTS FOR
WHAT TRAINING IRB MEMBERS OR HRP
PROFESSIONALS MUST HAVE BUT
CERTAINLY THAT'S A FREE RESOURCE
WE HAVE ON OUR SITE.
YOU CAN TAKE THE TRAINING.
THERE'S FIVE PARTS.
AFTER EACH ONE YOU RECEIVE A
CERTIFICATE.
WE DO NOT KNOW WHO TAKES THE
TRAINING.
WE DON'T SAVE THE CERTIFICATES.
BUT CERTAINLY IT'S SOMETHING
THAT AN INSTITUTION COULD DECIDE
TO USE THAT FIVE-PART SERIES,
AND SAY HEY, WE'D LIKE YOU TO
COMPLETE THIS AND THEN AN
INDIVIDUAL CAN GO THROUGH AND,
AGAIN, UPON COMPLETION THEY HAVE
A PDF WHICH THEY CAN PUT THEIR
OWN NAME BUT THAT'S SOMETHING WE
DO NOT MANAGE WHO COMPLETES OR
TAKE DOWN ANY INFORMATION LIKE
THAT.
>> THANK YOU.
>> YOU'RE WELCOME.
>> ANY OTHER QUESTIONS?
>> IF NO OTHER QUESTIONS I NEED
TWO OR THREE MINUTES TO GET
THINGS ON AND OFF THE PODIUM
SYSTEM AND WE CAN TRANSITION TO
REVIEWING.
>> WE'RE GOING TO GO BACK TO THE
SINGLE IRB REVIEW DRAFT BECAUSE
OF CHANGES.
WE'LL TRY TO DO THAT TODAY.
>> CAN WE WALK AROUND.
>> TAKE THREE MINUTES, FIVE
MINUTES.
THANKS TO MARK AND DAVID FOR
TURNING THIS DOCUMENT AROUND TO
HOPEFULLY FINISH IT TODAY.
SO, WE'RE GOING BACK TO SINGLE
INSTITUTIONAL REVIEW BOARD FOR
OHRP DRAFT GUIDANCE, I'M GOING
TO TURN IT OVER TO YOU, DAVID.
>> THANKS.
AND HONESTLY, MARK DID THE HEAVY
LIFTING GETTING THIS -- OH, COME
ON NOW.
>> ARE WE SUPPOSED TO BE SEEING
SOMETHING OTHER THAN THE SLIDES
FROM THE LAST --
>> I'M WORKING ON IT.
>> THANK YOU.
>> THERE WE GO.
OKAY.
ALL RIGHT.
SO, IN THE -- YEAH, THANKS TO
MARK REALLY FOR CHURNING THIS
OUT OVER THE LAST COUPLE SESSION
WHILE OTHER PEOPLE WERE
SPEAKING.
WE'RE GOING TO JUMP THROUGH THE
CHANGES AND NOT GO BACK THROUGH
THE ENTIRE DOCUMENT.
HERE IN THE DISCUSSION SECTION
WE'VE GOT THIS ADDED LANGUAGE
ABOUT PROCESS.
DOES THAT WORK FOR EVERYBODY?
>> HOW DOES THAT LOOK FOR FOLKS?
I'M SEEING GENERAL AGREEMENT.
I DON'T SEE DISSENT.
>> WORKING ON IT.
>> I'M SORRY, I NEED TO PULL THE
DOCUMENT.
IS THE ISSUE THAT WE WANT THE
GUIDANCE ACTUALLY HAVE SPECIFIC
PROCESSES OR GIVE GUIDANCE ON
THE FACT THAT YOU SHOULD HAVE A
PROCESS AND SOME ELEMENTS YOU
SHOULD CONSIDER?
I DON'T REMEMBER WHAT WE TALKED
ABOUT THIS MORNING, I NEED TO
PULL THE ORIGINAL.
THAT WAS MY COMMENT.
>> RIGHT.
THIS IS NEW TEXT, ORIGINAL TEXT
IS WHAT PRECEDES IT.
>> OKAY.
>> THIS IS IN ADDITION, NOT A
CHANGE, CORRECT.
>> OKAY.
>> WHILE YOU'RE THINKING, LET ME
THINK OUT LOUD.
GENERALLY THINK YOU CAN MAKE AN
OBSERVATION THAT SOMETHING'S
MISSING IT'S NICE TO SAY WHAT
YOU WANT THERE WHEN YOU SAY IT'S
MISSING.
I THINK THE QUESTION IS DO WE
WANT THE GUIDANCE TO
SPECIFICALLY TALK ABOUT WHAT
THAT PROCESS OUGHT TO BE OR TO
SIMPLY SAY THAT IRBs THAT
FUNCTIONEL AS SINGLE IRB OUGHT
TO HAVE APPROPRIATE PROCESS IN
PLACE, SO THOSE RELYING
INSTITUTIONS WOULD KNOW WHAT
THAT PROCESS IS?
NOT THAT WE'RE GOING TO SAY THIS
IS THE PROCESS YOU SHOULD HAVE
BUT IF I'M GOING TO RELY ON YOU
I WANT TO KNOW WHAT THE PROCESS
IS.
>> SO WHY DON'T WE PARKING LOT
THAT FOR THE MOMENT BECAUSE MARK
WAS JUST WHISPERING PROCESS IS
MENTIONED IN OTHER PLACES.
NEW LANGUAGE, THERE'S PROCESS --
>> GREAT.
THANK YOU.
>> PUT IN.
YEAH, LET'S -- ALL RIGHT.
HERE WE JUST HAVE WHAT WAS
SUGGESTED FOR THIS PARAGRAPH.
>> IS THAT SERVICES OR IS THE S
CROSSED OUT?
>> NO, THAT IS THERE.
>> OKAY.
>> IT IS NOW, THAT'S FOR SURE.
>> THAT'S THE RESPONSE TO THE
PUBLIC COMMENT WE HAD.
>> YES.
>> OKAY, THAT'S GOOD.
>> LOCAL SITE REVIEW AND
APPROVAL THIS ADDED LANGUAGE.
>> ONE OF THE THINGS WE TALKED
ABOUT THIS MORNING ALSO ON LINE
117 IN ADDITION TO THOSE EXTREME
CIRCUMSTANCES NOT BEING IN THE
STUDY, THAT COULD BE AN ARGUMENT
FOR WHY YOU WOULD SEEK AN
EXCEPTION.
WE DID TALK ABOUT THAT AS WELL.
SO JUST ADD SOMETHING TO THE END
OF THE SENTENCE TO SAY, OR WITH
THE SINGLE IRB'S JUDGMENT
REGARDING THAT PROTOCOL HAS
OPTION OF NOT BEING A SITE IN
THE STUDY, I DON'T KNOW WHAT THE
LANGUAGE SHOULD BE, OR THEY
COULD CONSIDER SUBMITTING --
REQUESTING REQUEST FOR EXCEPTION
BECAUSE OF -- YOU KNOW,
SOMETHING ALONG THOSE LINES.
>> I'M ASSUMING IF YOU REQUEST
EXCEPTION IT MEANS THE PROTOCOL
COULD HAVE A LOCAL AMENDMENT OR
LOCAL MODIFICATION.
THE PROTOCOL WOULD HAVE TO BE
CONSISTENT ACROSS THE SITES.
I'M CONFUSED WHAT THE EXCEPTION
WOULD BE FOR.
>> IMPLYING, CONSUELO RAISED A
CONCERN PEOPLE NOT BEING ABLE TO
BE IN THE STUDY, IF YOU CAN'T BE
IN THE STUDY THAT'S NOT GOOD
EITHER, BEING ABLE TO DO THE
STUDY WOULD BE TO GET AN
EXCEPTION TO ALLOW YOU TO HAVE
YOUR OWN LOCAL IRB OR YOUR OWN
IRB OF CHOICE DO THE REVIEW SO
THAT YOU COULD STILL PARTICIPATE
IN THE STUDY.
I THINK THAT'S WHAT WE SAID.
>> LOGICALLY THAT ASSUMES
WHATEVER PROTOCOL THE LOCAL IRB
APPROVES IS CONSISTENT AS THE
OTHER PROTOCOL.
>> IT'S THE SAME STUDY BUT WITH
LOCAL MODIFICATIONS SIMILAR FOR
THE SINGLE IRB MANDATE WHERE YOU
WOULD HAVE SITUATIONS WHERE YOU
MIGHT HAVE A STUDY AND --
CURRENTLY YOUR LOCAL IRB COULD
HAVE MADE CHANGES, ADDING THINGS
TO THE CONSENT FORM.
>> I'M LOCKED INTO THE
PHARMACEUTICAL MODEL.
YOU COULDN'T DO THAT.
THE NEW CLINICAL TRIAL
REGULATIONS DON'T ALLOW SPECIFIC
AMENDMENTS SO IT'S VERY
INTERESTING.
>> I WANT TO MAKE SURE THAT'S --
>> THAT'S FINE.
I AGREE BECAUSE OF SOME
CIRCUMSTANCES.
>> I DON'T KNOW, CONSUELO, IF
YOU HAD THOUGHTS THERE.
>> WHAT LINDA SUGGESTED IS ALONG
THE LINES OF WHAT I HAD IN MIND
AFTER THE LAST DISCUSSION.
THE ISSUES SPECIFICALLY ABOUT
HAVING LOCAL REVIEW, PEOPLE NEED
TO -- THERE ARE GOING TO BE
NUANCES AROUND ENGAGING,
INVOLVING CERTAIN COMMUNITIES IN
RESEARCH, AND YOU REALLY NEED TO
BE ABLE TO HAVE THAT LOCAL
PERSPECTIVE IN THE REVIEW.
NOW, THERE COULD BE ACTUALLY NO
DIFFERENCE ONCE THEY HAVE A
REVIEW BUT IF THERE ARE CONCERNS
THEN THOSE NEED TO BE
APPROPRIATELY ADDRESSED OR ELSE
WE'LL CONTINUE TO HAVE ISSUES
AROUND LACK OF REPRESENTATION IN
THE TRIALS.
>> SO I JUST WANT TO MAKE SURE,
TO THAT POINT I GUESS IT COULD
BE A SITUATION WHERE IT'S THE
SAME PROTOCOL BUT THERE ARE
CERTAIN ASPECTS THAT WOULD HAVE
TO BE REVIEWED BY THE LOCAL IRB
AND YOU MIGHT MAKE SOME
MODIFICATIONS TO CERTAIN THINGS
LIKE HOW TO RECRUIT OR CERTAIN
ASPECTS THAT WOULDN'T HAPPEN
OTHERWISE.
IS THAT WHAT WE'RE SAYING?
>> I THINK SO.
I MEAN, I THINK WHAT WE'RE NOT
DOING IS RULING ANYTHING OUT.
I WOULD SEE SOME OF THIS, WELL,
THE LAST RESORT WOULD BE THE NOT
PARTICIPATING IN THE STUDY BUT,
YOU KNOW, PRESUMABLY THERE WOULD
BE -- IF THERE WERE TO BE LOCAL
SITE DIFFERENCES THOSE WOULD BE
CAREFULLY NEGOTIATED AND WORKED
OUT SO THEY AREN'T HAVING AN
OVERALL IMPACT ON THE INTEGRITY
OF THE STUDY.
>> I GUESS MAYBE TWO THINGS.
WE DO WANT PEOPLE, IF -- THIS IS
IN REGARDS TO WHEN THERE ARE
DISAGREEMENTS THAT CAN'T BE
RESOLVED, SOMETIMES THAT MIGHT
INVOLVE A LOCAL REVIEW WITH
MODIFICATIONS BUT THEN ALSO IF
THAT IS UNACCEPTABLE, THEN I DO
THINK WE WANT TO HAVE AN
OPPORTUNITY FOR THERE TO BE
EXCEPTIONS TO THE SINGLE IRB.
>> SKIP?
>> I'M JUST WONDERING IF -- I
AGREE WITH WHAT'S BEEN SAID,
LOOKING AT THE WORDING
REQUESTING EXCEPTION TO THE
SINGLE IRB REQUIREMENTS TO ALLOW
FOR LOCAL REVIEW AND
MODIFICATIONS AS APPROPRIATE,
SOMETHING LIKE THAT.
JUST TO PROVIDE CONTEXT WHY YOU
WANT THAT.
I'M NOT WEDDED TO THAT LANGUAGE
BUT SOMETHING ALONG THOSE LINES.
>> I'LL PUT IT THERE TO SEE WHAT
PEOPLE THINK.
>> SOMEONE MORE VERSED IN IRB
LANGUAGE WILL HAVE TO WEIGH IN
BUT I PRESUME YOU DON'T NEED AN
EXCEPTION TO THE SINGLE IRB IF
IT'S JUST MODIFICATIONS.
BUT YOU WOULD NEED AN EXCEPTION
IF -- IF FOR THE FOR EXAMPLE
GIVEN EARLIER, IF FOUR OF THE
FIVE SITES WERE UNDER THE SINGLE
IRB AND ANOTHER SITE WANTED TO
HAVE A SEPARATE.
>> THE EXCEPTION WOULD BE TO
MAKE ONE OF THE SITES -- ALLOW
ONE OF THE SITES TO HAVE ITS
LOCAL IRB BE THE IRB OF RECORD
FOR THAT PROTOCOL AT THAT SITE.
>> RIGHT, RIGHT.
>> BUT THE REASON IS SO THEY CAN
MAKE MODIFICATIONS.
>> YEAH.
>> YEAH, AND I DON'T THINK THE
MODIFICATION APPLIES TO
PROTOCOL, LIKE AN AMENDMENT.
>> I'M BEING VERY AMBIGUOUS ON
THAT.
>> YEAH.
>> MAYBE REQUESTING AN EXCEPTION
TO THE SINGLE IRB REQUIREMENT TO
ALLOW FOR -- THAT'S WHAT I'M
TRYING TO SAY.
IT'S NOT BECAUSE OF LOCAL -- IF
YOU HAVE AN EXCEPTION SINGLE IRB
REQUIREMENT THAT IMPLIES YOU CAN
HAVE LOCAL REVIEW SO I'M NOT
SURE IF THAT ADDS ANYTHING.
IT'S REALLY BECAUSE YOU CAN'T --
OR REQUEST AN EXCEPTION TO THE
SINGLE IRB REQUIREMENT BECAUSE
YOU CAN'T RESOLVE THE DISPUTE.
IT'S GOING TO DEPEND ON WHAT THE
DISPUTE WAS IN TERMS OF WHAT IT
IS YOU'RE ASKING FOR AND COULD
BE FOR DIFFERENT REASONS SO
MAYBE JUST --
>> IT COULD BE.
I THINK TO SKIP'S EARLIER
CONCERN, I THINK, YOU KNOW,
WHAT'S NOT KNOWN HERE IS, AGAIN,
WHETHER A SPONSOR WOULD BE
WILLING TO ACCEPT VARIATIONS AT
THE LOCAL SITE.
IT MAY BE OUT OF A SINGLE IRB'S
HANDS OR LOCAL IRB'S HANDS, IF
THE SPONSOR SAYS WE'RE NOT
ALLOWING, YOU KNOW, ONE OF SEVEN
SITES TO GO THEIR OWN WAY.
>> LET ME GIVE AN EXAMPLE JUST
EWING THE -- USING THE NEW
CLINICAL TRIAL.
A SPONSOR WANTS TO DO 16 AND UP,
FINE IN COUNTRIES LIKE SCOTLAND,
YOU'RE AN ADULT AT 16.
BUT THERE ARE SOME OTHERS WHO
SAY, NO, WE'RE NOT GOING TO LET
YOU ENROLL CHILDREN, SO IT'S
GOING TO BE 18 AND UP.
WHAT DO YOU DO?
IF YOU CAN'T ALLOW FOR LOCAL
MODIFICATION, THAT SITE THAT
SAYS 18 AND UP ONLY WOULDN'T BE
ABLE TO PARTICIPATE.
SO, THAT'S A MODIFICATION THAT
DOESN'T HAVE ANY BIG IMPACT ON
THE PROTOCOL ITSELF.
AND SO THERE'S SOME
MODIFICATIONS THAT CAN BE DONE,
OTHERS THAT CAN'T.
AND I WAS JUST TRYING TO CAPTURE
LANGUAGE THAT MODIFICATIONS AS
APPROPRIATE IS TRYING TO BE
VAGUE AROUND THAT SO --
OTHERWISE WE'RE GOING TO GET
INTO THE WEEDS VERY QUICKLY.
>> THAT'S A REALLY GOOD EXAMPLE
THAT -- REAL WORLD EXAMPLE,
HELPFUL TO THINK ABOUT A
DIFFERENCE BETWEEN SITES.
NOT SURE THAT'S AN EXAMPLE IN A
WOULD TAKE YOU TO THE POINT OF
SAYING WE NEED A LOCAL IRB TO
REVIEW THIS BUT YOU KNOW WHAT
I'M SAYING, YOU CAN IMAGINE
THERE'S MULTIPLE TYPES OF
EXCEPTIONS THAT MIGHT BE
APPROPRIATE.
I'M NOT COMING UP WITH ANYTHING
BETTER MYSELF.
>> IT'S GOOD ENOUGH FOR
GOVERNMENT WORK.
>> I'M GOING TO MOVE ON.
AND IF WE HAVE TIME AND ENERGY
AND INTEREST AND WE CAN LOOK AT
IT AGAIN.
SO THE COMPLIANCE SECTION ...
>> LINE 146 AT THE BEGINNING.
>> IT'S GOOD.
OKAY, THAT WAS MORE
STRAIGHTFORWARD.
THE UNFUNDED COLLABORATOR
SECTION WE'VE GOT SOME LANGUAGE
HERE.
GOOD.
OKAY.
>> GO BACK, DAVID.
THERE'S A WORD, INSTEAD OF
ATTACH, HOW ABOUT APPLIED?
TO BE APPLIED.
APPLIED TO.
>> JUST APPLY, RIGHT?
NOT APPLIED.
>> APPLY, APPLIED, EITHER WAY.
>> THE SECOND SENTENCE THERE,
NON-FEDERAL FUNDERS MIGHT
REQUIRE?
>> IT'S JUST A CALL OUT TO THAT,
THAT FACT, THAT SPONSORS ALREADY
CAN AND DO MANDATE USE OF A
SINGLE IRB.
>> I GUESS COULD YOU ADD
NON-FEDERAL IN FRONT OF FUNDER?
>> WHETHER THEY ARE FEDERAL OR
NON-FEDERAL MIGHT REQUIRE, IT'S
A FOLLOW-UP FROM THE FIRST
SENTENCE.
SOUNDS LIKE IT'S TRYING TO MAKE
CLARIFICATION BUT IT'S NOT AS
CLEAR.
>> ALL RIGHT.
IS THAT GOOD, WALTER?
JUST SAY IT'S GOOD.
THERE IT IS.
>> THAT'S FINE.
>> OKAY.
>> MINOR POINT, COMPILATION OF?
YOU COULD PUT OF.
>> WHICH LINE?
>> 194.
COMPILATION WITH UPDATES OF A
SET.
NO, NO.
RIGHT THERE.
OF, YEAH.
>> OKAY.
>> IT WAS A TYPO.
>> OHRP.
>> EAGLE EYES HERE, OKAY.
I FORGOT HOW MUCH FUN IT WAS TO
STAND AND TYPE IN FRONT OF
EVERYBODY.
MUCH BETTER KEY BOARD.
THE WORD POLITICAL IS STILL
HERE.
AFTER THE DISCUSSION ONE
SUBCOMMITTEE MEMBER, I'M GOING
TO READ THE E-MAIL, IT'S FROM
SUSAN STAYN, HARMONIZATION
SUBCOMMITTEE, OFFERED MARK AND A
GOOD REMINDER.
SHE NOTED THAT THIS GROUP MAY
NOT RECALL THE REASON THE
SUBCOMMITTEE ADDED POLITICAL TO
2018, WE HAD DISCUSSION ABOUT
THIS.
POLITICAL RESEARCH PRIMARILY
MEANING RESEARCH RELATED TO
POLITICAL ELECTIONS IS A
SENSITIVE TYPE OF RESEARCH FOR
WHICH LOCAL IRB REVIEW IN
COORDINATION WITH MANY
INSTITUTIONAL STAKEHOLDERS IS
HIGHLY ADVANTAGEOUS, SERIOUS TAX
EXEMPTI FOR NON-PROFIT RESEARCH
INSTITUTIONS, STATE LAWS, STATE
OPINIONS AND RELATED ISSUES THAT
MAKE INSTITUTIONAL RISK
TOLERANCE AND IMPORTANT SOURCE
OF INPUT FOR A LOCAL IRB.
THESE ISSUES EXTEND WELL BEYOND
THE HRPP HYPOTHETICALLY
CONSIDERED REALTIME INTERVENTION
RELATED TO POLITICAL CAMPAIGN
ACTIVITIES OR RESEARCH WITH
LARGE SOCIAL MEDIA COMPANIES
WITH PROPOSED DECEPTION AND
INTERVENTIONS PRIOR TO VOTING,
MUCH MORE FOR LOCAL INSTITUTIONS
WHOSE TAX EXEMPT STATUS MAY BE
AT ISSUE.
IN OTHER WORDS, THIS IS NOT
SIMPLY RESEARCH ON POLITICAL
ISSUES, THAT MAY NOT HAVE BEEN
CLEAR FROM THE SUBCOMMITTEE'S
SUCCINCT PRIOR WORDING.
>> GOOD POINT.
ANYBODY HAVE AN OBJECTION TO
KEEPING IT IN THERE?
>> IS SUSAN STILL WATCHING?
THANKS, SUSAN.
THAT'S HELPFUL.
WE HAVE ADDED TEXT HERE.
>> ACTUALLY, SKIP, IS THE WORD
POLITICAL STILL TOO CHARGED?
THE ISSUE THAT WAS RAISED WAS
THAT THERE MAY BE -- TOPICS MAY
HAVE LIKE TAX IMPLICATIONS.
>> NO, I THOUGHT ALL OF THOSE
DETAILED WERE VERY HELPFUL,
FRANKLY.
IT'S NOT JUST A RED STATE/BUT
STATE -- RED STATE-BLUE STATE
THING.
IT WAS NOT AN UNINTENDED
POLITICAL STATEMENT.
>> PARDON MY LACK OF KNOWLEDGE
BUT WOULD -- ARE WE TALKING
ABOUT CLINICAL RESEARCH OR --
>> ANY.
>> NO, I MEAN FOR THE PURPOSE OF
THE SINGLE IRB REQUIREMENT IT'S
NOT SPECIFICALLY FOR CLINICAL
RESEARCH.
IT'S NO OF ANY MULTI-SITE
RESEARCH.
>> BUT THIS DOCUMENT IS NOT
SPECIFICALLY ABOUT CLINICAL
RESEARCH, RIGHT?
>> CORRECT.
>> SO IF WE'RE GOING TO REALLY
SPECIFICALLY HAVE EMPHASIS ON
POLITICAL IT SEEMS THERE ARE A
LOT OF OTHER RESEARCH TOPIC
AREAS THAT ALSO HAVE
IMPLICATIONS RELATED TO
COMMUNITY TRUST AND STIGMA, SO I
WANT TO MAKE SURE WE'RE GIVING
THE APPROPRIATE AMOUNT OF WEIGHT
TO POLITICAL HERE.
>> I DON'T KNOW IF OTHERS IN THE
ROOM HAVE COMMENTS.
IS THERE LANGUAGE THAT YOU THINK
IS MISSING THAT YOU HAVE IN MIND
THAT WE COULD TRY OUT HERE?
>> I DON'T KNOW THAT THERE'S
ANYTHING THAT'S MISSING.
MY CONCERN IS MORE ABOUT USING
THE SPECIFIC POLITICAL CONTEXT
AS JUSTIFICATION FOR THE
LANGUAGE IN THIS SECTION.
>> THE WAY I HEARD THE
JUSTIFICATION THAT WAS GIVEN
FROM LISTENING ONLINE PUTS THIS
ISSUE OF POLITICAL IN MY MIND
SIMILAR TO KNOW WHAT STATE LAWS
EXIST AROUND RESEARCH AND
EDUCATIONAL INSTITUTIONS AND
SCHOOLS AND THAT SORT OF THING,
I MEAN WHICH CAN ALSO HAVE
SPECIFIC LAWS IN THE LOCAL
CONTEXT, COULD HAVE IMPACT, ET
CETERA, ABOUT THE KINDS OF
THINGS YOU CAN DO WITH SCHOOL
KIDS WITHOUT PARENTS, BLAH,
BLAH, BLAH.
SO I SEE IT AS LESS -- AS MORE
OF A, YOU KNOW, THE READER MAY
NOT KNOW ALL OF THAT, BUT I
DON'T SEE THE WORD POLITICAL AS
PROBLEMATIC IN THAT LIGHT.
WHETHER WE NEED TO ADD ANYTHING
ELSE, I MEAN, BUT I THINK THEN
WE GET INTO A LAUNDRY LIST OF A
LIST OF CONTROVERSIAL OR
SENSITIVE ISSUES.
I'M NOT SURE WE NEED TO GO
THERE.
>> YEAH, THAT'S ALWAYS FROM
PREVIOUS WORK WITH SACHRP,
THAT'S ALWAYS A RABBIT HOLE WE
SOMETIMES GO DOWN, COMING UP
WITH EXAMPLES AND SUDDENLY
IT'S --
ANY ADDITIONAL INPUT ON CHANGING
OR GO WITH IT?
>> I THINK IT SEEMS PROBLEMATIC
TO ME, WHAT SITE'S LEADERSHIP,
HOW IS IT INTERPRETED, WHAT ARE
WE TALKING ABOUT?
>> THIS IS ONLINE 221.
CONSULTATION WITH SITE AND
AMBIGUOUS ON LEADERSHIP?
>> WHAT WAS INTENDED BY
LEADERSHIP?
>> ASSUMING LOCAL P.I. OR
SOMEONE WHO WOULD KNOW THAT
LOCAL.
JUST SITE.
IT MAKES IT --
>> YEAH, I GUESS COMPLICATING
FEATURE WITHIN THE STATEMENT IS
EMBEDDED THE NOTION NOT ALL
SITES HAVE A LOCAL P.I., SOME
SITES ARE DOING OTHER
ACTIVITIES.
>> YOU'RE SAYING OF PROCESS,
LEAD HERSHIP THAT WOULD WEIGH
IN?
I WAND TO MAKE SURE I UNDERSTAND
WHAT THAT WORD MEANS.
>> I WAS THINKING IF AN
INVESTIGATOR IS GOING TO PROPOSE
A MULTI-SITE STUDY, THE
INVESTIGATOR THINKS, GOSH, THIS
MAY BE A SENSITIVE SET OF ISSUES
REQUIRING INTENSE LOCAL REVIEW,
INVESTIGATOR WOULD SAY TO THE
OTHER P.I.s AT THE SITES,
SITE'S LEADERSHIP, WHAT DO YOU
THINK?
DO YOU THINK THIS MERITS A
SINGLE IRB EXCEPTION AND WOULD
YOU BE SUPPORTIVE OF THAT?
THAT INVESTIGATOR WOULD TALK TO
THE INSTITUTIONAL OFFICIAL AT
THAT SITE TO MAKE SURE EVERYBODY
WAS ON BOARD.
CONSULTATIVE PROCESS FOR ALL THE
INVESTIGATORS AND SITES TO TALK
AMONGST EACH OTHER.
>> WOULD IT BE HELPFUL TO PUT
THE WORD "OTHER"?
JUST PUT OTHER, OR OTHER
POTENTIAL SITES?
IT'S A PROPOSAL, OTHER PROPOSED
SITES?
>> ONE MORE CLARIFICATION.
IS THIS SPEAKING TO WHAT THE
BEGINNING OF THE PARAGRAPH IS
ABOUT WHICH IS RELATED TO A
STUDY WITH A SMALL NUMBER OF
SITES OR ARE WE NOW TALKING
ABOUT MORE BROADLY SITES?
STUDIES THAT ARE NOT JUST
INCLUDING A SMALL NUMBER OF
SITES?
>> YEAH, I MEAN WE'RE ALL
LOOKING AT THE LANGUAGE FOR THE
FIRST TIME.
SO I THINK THAT THIS IS IN THE
SECTION THAT IS ABOUT HAVING
EXCEPTIONS.
AND SO THE EXCEPTIONS WOULD BE
AS DEFINED ABOVE, COULD EITHER
BE BASED ON IF YOU GO UP, DAVID,
A LITTLE BIT, COULD BE BASED ON
HAVING FIVE OR FEWER SITES OR
THE EXCEPTION COULD BE RESEARCH
FOR WHICH A SINGLE IRB CAN'T
MEET NEEDS OF THE POPULATION OR
INVOLVING POLITICAL OR SENSITIVE
ISSUE, ANY OF THOSE SITUATIONS
NOT LIMITED TO JUST FIVE OR
FEWER SITES BUT THE INVESTIGATOR
MIGHT SAY, GOSH, I THINK THAT
THERE ARE THINGS ABOUT THIS
STUDY THAT WOULD MERIT EXCEPTION
AND GO THROUGH A CONSULTATIVE
PROCESS, I THINK THAT'S WHAT IT
MEANS.
>> YEAH, I SEE CONSUELO'S POINT,
THE BEGINNING OF THE PARAGRAPH
GOES BACK TO SMALL SITE NUMBERS
MAKING IT INEFFICIENT AND JUMPS
INTO PROCESS.
>> WELL, WHY DON'T WE BREAK A
NEW PARAGRAPH IN FRONT OF "IN
MANY CASES."
>> OKAY.
>> IT TAKES IT AWAY FROM THE
REFERENCE TO THE FEW SITES.
>> OKAY.
>> I DON'T KNOW IF THAT WOULD BE
HELPFUL OR MAKE IT CONFUSING TO
PUT THE TEXT BENEATH.
PUT THE NUMBER IT'S REFERRING
TO.
>> I WAS GOING TO SUGGEST THAT
BEFORE BUT THEY DON'T CORRESPOND
EXACTLY.
SORRY.
YOU'VE GOT THE FIRST SENTENCE
ELABORATES ON NUMBER 1, BUT THE
REMAINING BLOCK TEXT KIND OF
COVERS 2 AND 3, THAT'S WHY I
DIDN'T SUGGEST DOING THAT.
BUT THE TEXT THAT FOLLOWS IS
JUST ELABORATION OF 1, 2 AND 3.
YOU HAVE TO BREAK THAT OUT,
SEEMS LIKE YOU WOULD BREAK IT AS
A MATTER OF PROCESS IS THE NEW
PARAGRAPH, IN MANY CASES
ELABORATION OF 2 AND 3 AS I'M
UNDERSTANDING THAT.
>> BASICALLY THE ORIGINAL TEXT
COVERS 1, 2, AND 3.
>> RIGHT.
>> THAT IS PROCESS.
>> RIGHT.
>> OKAY.
>> ONE OTHER POINT, AND AFTER 2.
IS THERE ANY MISINTERPRETATION
FOLLOWING CATEGORIES?
DO YOU REALLY NEED IT?
IS IT OR, OR, OR, NOT AND?
YOU DON'T WANT SOMEONE TO
INTERPRET THIS TO MEAN THEY BOTH
HAVE TO APPLY.
>> YOU COULD PUT AND/OR.
THAT'S FINE, A CLARIFICATION.
>> OR GET RID OF "AND" AND JUST
PUT "OR."
>> OKAY.
>> SHOULD BE AND.
ALL THINGS THAT WERE
RECOMMENDED.
>> RIGHT BUT THEY ARE
DISJUNCTIVE.
PUT A CATEGORY AS INDEPENDENT
POTENTIALLY APPROPRIATE
EXCEPTIONS.
>> IF YOU LOOK AT THE LEAD-IN
SENTENCE, ALL THREE THINGS
SACHRP RECOMMENDED.
IT DIDN'T RECOMMEND ONLY ONE OF
THOSE THINGS.
>> RIGHT.
>> OR ANOTHER OR ANOTHER.
IT RECOMMENDED ALL THREE.
>> YES.
>> I AGREE WITH THAT.
MY CONCERN IS THAT SOMEONE MIGHT
READ THAT TO MEAN YOU HAVE TO
MEET BOTH 2 AND 3 IN ORDER FOR
IT TO BE AN EXCEPTION BY THE
WORD "AND," NOT THAT IT'S
RECOMMENDING ALL THREE.
I'M NOT THE LEGAL -- YOU KNOW.
>> SOUND LIKE YOU'RE CHANNELED
AN ENGLISH TEACHER.
FOLLOWING THREE CATEGORIES AS
POTENTIALLY APPROPRIATE
EXCEPTIONS.
>> ONE OF THE FOLLOWING THREE
INDEPENDENT CATEGORIES.
>> OKAY.
THAT'S FINE, OKAY.
>> THAT DOESN'T SOLVE IT.
>> YEAH, WE'RE RECOMMENDING ALL
THREE ARE CATEGORIES.
WE'RE NOT RECOMMENDING ONE OR
MORE OF THE FOLLOWING.
IT'S THE ISSUE, YOU'RE MODIFYING
RECOMMENDATION, NOT MODIFYING
CATEGORIES.
>> LET'S GET RID OF IT.
>> ONE OF WHICH WOULD BE A
POTENTIALLY APPROPRIATE
EXCEPTION.
>> GET RID OF THE WORD "AND"
IT'S SOLVED, IN MY MIND.
>> WHAT ABOUT RECOMMENDED
CATEGORIES, COMMA, ANY WOULD BE
A POTENTIALLY APPROPRIATE
EXCEPTION TO THE SINGLE IRB
REQUIREMENT, HOW ABOUT THAT?
ANY ONE OF WHICH WOULD BE
POTENTIALLY APPROPRIATE
EXCEPTION TO THE SINGLE IRB
REQUIREMENT.
>> NOW YOU'RE --
>> ACTUALLY AN APPROPRIATE
EXCEPTION TO THE SINGLE IRB
REQUIREMENT.
>> VERY GOOD.
>> TAKE OUT THE S.
THERE YOU GO.
HOW'S THAT?
>> GOOD.
>> LAST THING WE DIDN'T FULLY
RESOLVE WAS THE -- THIS ONE,
LINDA?
>> YEAH.
>> THIS WAS MEANT TO BE GENERIC
REFERENCE TO -- ELABORATED BY
THE ADDITIONAL REFERENCES TO
PROCESS.
>> PERSONALLY I THINK WITH ALL
OF THE OTHER TEXT THAT I THINK
THIS IS FUN PERSONALLY.
SEEING IT IN THE OVERALL
CONTEXT.
>> WHY DON'T WE CHANGE SHOULD TO
COULD SO IT'S NOT PRESCRIPTIVE
BUT COULD.
>> [OFF MICROPHONE].
>> EXACTLY.
HOW DOES THAT SOUND?
OKAY.
>> THANKS.
>> YOU'RE WELCOME.
>> THOSE ARE ALL OF THE CHANGES,
DOUG.
>> ALL RIGHT.
THOSE ARE THE CHANGES.
EVERYBODY HAPPY WITH THEM?
ANYBODY NOT HAPPY WITH THEM?
IS THERE A MOTION?
>> LET'S HAVE A MOTION.
>> I MOVE I'M HAPPY WITH IT.
[LAUGHTER]
>> OKAY.
>> SORRY.
>> I THINK THAT WAS A MOTION TO
APPROVE, LET ME REPHRASE SKIP'S
MOTION.
>> I SECOND.
>> ANY FURTHER DISCUSSION?
LET'S VOTE.
ALL IN FAVOR?
ALL OPPOSED?
ABSTAIN?
OKAY.
THE MOTION PASSES.
>> THANKS, EVERYONE.
>> THANK YOU FOR YOUR HARD WORK
ON THAT, ALONG WITH THE
SUBCOMMITTEE.
ALL RIGHT.
THAT I THINK BRINGS US TO THE
END OF THE DAY.
WE'VE HAD A PRODUCTIVE DAY.
WE'VE APPROVED TWO ITEMS.
WE HAVE ANOTHER ONE SORT OF
LINED UP FOR LIKELY APPROVAL
TOMORROW.
AND TOMORROW WE WILL BE
VISITING - TWO -- THREE FAIRLY
SIGNIFICANT ISSUES.
WE'LL GO BACK TO ONE OF THE
ITEMS WE'VE BEEN WORKING ON FOR
A LONG TIME, THAT IS THE
INTERPRETATION OF HHS SUPPORT.
WE'LL START THE MORNING WITH
THAT AND THEN STEPHEN IS GOING
TO BE JOINING US TO BRING US
THROUGH THE ARTIFICIAL
INTELLIGENCE DOCUMENT.
I THINK HIS HOPE IS THAT WE MAY
BE ABLE TO APPROVE THAT
TOMORROW.
AND WE'LL FINISH THE DAY WITH
DISCUSSION OF SOCIAL MEDIA USE
ON HUMAN SUBJECTS RESEARCH AND
THE IMPACT.
>> IS THERE AN UPDATE, IS THERE
DOCUMENT FOR REVIEW FOR
ARTIFICIAL INTELLIGENCE?
THERE WASN'T A FEW DAYS AGO.
>> YEAH, THERE SHOULD BE.
>> IT SHOULD BE IN THE DOCKET,
I'LL CIRCULATE IT AGAIN, YEAH.
>> IT'S NOT IN THE PAPERWORK.
>> NO, THOSE ARE ALL DAY 1.
ACTUALLY WE SHOULD HAVE COPIES
OF THAT, BEFORE YOU LEAVE
TONIGHT, A HARD COPY.
>> YES, SKIP?
>> YOUR PREROGATIVE AS CHAIR, IF
WE HOPE TO APPROVE THE A.I.
DOCUMENT DO WE WANT TO START
WITH THAT IN CASE STEVE NEEDS TO
DO MODIFICATION WHILE WE DO THE
SECOND AGENDA ITEM AND COME BACK
WITH THE REVISION?
>> I THINKING STARTING WITH HHS
SUPPORT.
LONGER AND FOR THE SAME REASON.
>> OH, OKAY.
>> IN CASE THAT NEEDS TO BE
WORKED ON.
>> NO PROBLEM.
>> AND WHO KNOWS, THAT MAY NOT
TAKE 45 MINUTES.
WE'LL SEE.
YEAH, THANKS FOR THAT.
OKAY.
>> WE NEED TO FORMALLY CALL FOR
PUBLIC COMMENT, EVEN IF THERE IS
NO PUBLIC COMMENT.
>> OKAY.
>> WE HAVE CALLS.
FOR THE RECORD THERE WAS NONE
SUBMITTED.
>> WE'VE GOTTEN A FEW LATE
QUERIES BY E-MAIL THAT WE'VE
CIRCULATED TO THE GROUP, SOME
HAVE BEEN INCORPORATED INTO THE
DOCUMENTS ALREADY.
ANYTHING ELSE, JULIE?
>> I JUST NOTE THAT TOMORROW WE
DO START AT 9:00, NOT 10:00.
IF EVERYONE CAN GET HERE
ACCORDINGLY AND THE SAME
PROCESSES WILL BE IN PLACE
TOMORROW FOR LUNCH.
IF THERE'S ANYTHING ELSE YOU
COME ACROSS THIS EVENING YOU
WANT TO BRING TOMORROW, FOR
NOURISHMENT, FEEL FREE.
OKAY.
THANK YOU.
THANK YOU ALL VERY MUCH.
>> ALL RIGHT.
WE'RE ADJOURNED.