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. >> 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. >> 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. 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.