>>WELCOME TO OUR OCTOBER MEETING OF THE SECRETARY'S ADVISORY COMMITTEE ON HUMAN RESEARCH PROTECTIONS. MY NAME IS DOUG DIEKEMA AND I AM THE CHAIR OF THE COMMITTEE AND I'M GOING START BY DOING A ROLL OF OUR MEMBERS. SO IF YOU ARE PRESENT, PLEASE SIGNIFY AS SUCH. MARY ELLEN ALLEN FROM ALLEN HEALTH LAW. SANDRA SOO JIN LEE FROM COLUMBIA. >>YES, HELLO. >>SKIP NELSON FROM JOHNSON&JOHNSON. >>GOOD MORNING. >>AND LOIS SHEPHERD IS NOT PRESENT. >>WALTER STRAUS. >>PRESENT. >>AND CONSUELO WILKINS FROM VANDERBILT. >>PRESENT. >>WE HAVE A QUORUM. JULIA DO YOU WANT TO DO THE REST OF ROLL. >>I WANT TO BRIEFLY ASK THE HHS EX-OFF EX-OFFICIO'S IF THEY CAN ANNOUNCE THEMSELVES. >>DIRECTOR OF THE ANALYTICAL POLICY. >>AND ASSOCIATE DIRECTOR. >>THANK YOU SO MUCH. ANY REPRESENTATIVES FROM HRSA. >>IT'S OLIVIA KLEIN FROM THE OFFICE OF SCIENCE POLICY FROM NIH. >>ADAM BURGER, OFFICE OF SCIENCE POLICY. >>SORRY. CDC. >>MIKA BASS WITH THE OFFICE OF SCIENTIFIC INTEGRITY. >>THANK YOU SO MUCH. >>AT THIS POINT I'D ASK ANY OTHER HHS EX-OFFICIO'S TO ANNOUNCE THEMSELVES. >>FROM HIQ. >>THIS IS MARIA CORREIA FROM THE OFFICE OF CIVIL RIGHTS. >>ALL RIGHT. I THINK WE'RE READY TO GO. BACK TO YOU. >>THANK YOU, JULIA. >>ONCE AGAIN, WELCOME TO OUR FALL MEETING. WE HAVE A RELATIVELY STRAIGHTFORWARD AGENDA WE'LL DEVOTE THE MAJORITY OF TODAY IF NOT ALL OF TODAY TO RECOMMENDATIONS SACHRP WILL MAKE REGARDING TWO NOTICES OF PROPOSED RULE CHANGES DESIGNED TO HARMONIZE FDA REGULATIONS WITH OTHER AGENCIES. AND THEN TOMORROW'S AGENDA WE HOPE TO HOPEFULLY COME TO SOME CLOSING OF TWO STATEMENTS WE'VE BEEN WORKING ON. THE ONE ON ARTIFICIAL INTELLIGENCE IN HUMAN RESEARCH PROTECTIONS AND THE OTHER ON THE USE OF SOCIAL MEDIA IN HUMAN SUBJECT PROTECTIONS. SO IT LOOKS LIKE IT SHOULD BE AN INTERESTING AGENDA AND I'M LOOKING FORWARD TO HEARING WHAT MEMBERS HAVE TO SAY. FIRST TO JERRY MENIKOFF FOR ANY OPENING REMARKS HE'D LIKE TO MAKE. >>THANK YOU, DOUG. >>I'D LIKE TO THANK THE MANY WHO WORKED ON GETTING US HERE AND THE CHAIRS OF THE SACHRP SUBCOMMITTEES AND THE SACHRP MEMBERS AND EX-OFFICIO MEMBERS AND OTHERS AT OHRP. A GREAT DEAL OF WORK GOES INTO MAKING THESE MEETINGS A REALITY. AND OF COURSE OUR THANKS TO MEMBERS OF THE PUBLIC. THANK YOU FOR BEING INTERESTED IN THESE ENDEAVORS. AS DOUG NOTED, THE NEXT TWO DAYS ARE PARTICULARLY NOTABLE SINCE MUCH OF THE AGENDA IS DEVOTED TO COMMENTING ON TWO FDA PROPOSALS THAT CAME OUT OF REQUIREMENT FROM THE 21st CENTURY CURES ACT SO MANY YEARS AGO WHICH REQUIRE OHRP AND FDA TO HARMONIZE THEIR REGULATIONS TO THE EXTENT POSSIBLE. I'D LIKE TO POINT OUT THAT HARMONIZATION IS ALMOST ALWAYS SOMETHING THAT PEOPLE AT OHRP ARE THINKING ABOUT. WE'RE CERTAINLY WELL AWARE THAT IN GENERAL IT IS BETTER FOR ALL CONCERNED WHEN MULTIPLE AGENCIES THAT ARE ENGAGED IN A SIMILAR GOAL HEAR THE GOAL OF PROTECTING PEOPLE IN RESEARCH HAVE SIMILAR RULES AND THERE'S NOT EXTRA WORK IN UNDERSTANDING DIFFERENT SETS OF RULES AND WORKS OUT FOR A VARIETY OF REASONS. IT'S OFTEN ISN'T THAT EASY TO MAKE RULES OR EVEN GUIDANCE BE AS HARMONIOUS AS WE WOULD IDEALLY LIKE THEM TO BE BUT IT IS ALWAYS SOMETHING THAT WE'RE STRIVING FOR SO IT'S PARTICULARLY PLEASING TO SEE SO MUCH OF THE MEETING DEVOTED TO HARMONIZATION ISSUES. AGAIN, THANKS EVERYBODY FOR PARTICIPATING AND I'LL HAND IT BACK TO YOU GUYS. >>THANK YOU, JERRY. >>THANKS FOR THAT HELPFUL CONTEXT AS WE EMBARK ON TODAY'S AGENDA WHICH WE ARE GOING TO DO I BELIEVE RIGHT NOW. DO WE HAVE ANY OTHER ANNOUNCEMENTS, JULIA, BEFORE WE START? >>I'M GETTING MESSAGES YOU'RE HARD TO HEAR, DOUG, SO IF EVERYONE CAN TRY TO SPEAK LOUDLY SO IT COMES OUT CLEARLY ON THE WEBCAST THAT WOULD BE TERRIFIC. BUT NO, I HAVE NO OTHER ANNOUNCEMENTS AT THIS POINT. THANK YOU. >>OKAY. THANK YOU. THEN WE WILL START AND WE ARE GOING START WITH AN OVERVIEW FROM THE FDA ON THESE PROPOSED RULE CHANGES AND TO THAT FOR US IS ANN MEEKER O'CONNELL. THE FLOOR IS YOURS. >>THANK YOU. JUST A CHECK THAT EVERYBODY CAN SEE THE SCREEN? >>YES. >>THANK YOU. AGAIN, I WANT TO THANK YOU FOR ALLOWING US FOR THE TIME TO TALK THROUGH THE PROPOSED RULES. ANN MEEKER O'CONNEL THE FDA'S DIRECTOR OF OFFICE POLICY AND THESE TWO PROPOSED RULES UNDER DISCUSSION TODAY ARE RESPONSIVE TO THE 21st CENTURY'S CURES ACT AND SPEAKS TO HARMONIZATION OF THE HUMAN PROTECTION REGULATIONS AND FDA TO THE EXTENT PRACTICABLE AND CONSISTNT WITH OTHER PROVISIONS. THE FDA PRIORITIZED REVIG -- REVISIONS OF RESEARCH THAT WOULD ENHANCE HUMAN SUBJECT PROTECTIONS OR WOULD REDUCE REGULATORY BURDEN. WE HAVE ISSUED A SERIES OF THREE PROPOSED RULES. THE FIRST WAS IN 2018 WHEN WE ISSUED A PROPOSED RULE ON INSTITUTIONAL REVIEW BOARD WAIVER OR ALTERATION OF INFORMED CONSENT FOR CERTAIN MINIMAL RISK CLINICAL INVESTIGATIONS. THIS RULE IS IN THE PROCESS OF HARMONIZATION. THE OTER TWO PROPOSED RULES WERE JUST PUBLISHED ON SEPTEMBER 28. THOSE ARE OUR INSTITUTIONAL REVIEW BOARD, COOPERATIVE RESEARCH PROPOSED RULES THAT WOULD REQUIRE ANY INSTITUTION LOCATED IN THE UNITED STATES PARTICIPATING IN FDA REGULATED COOPERATIVE RESEARCH TO RELY ON APPROVAL BY A SINGLE IRB FOR THAT PORTION OF THE RESEARCH THAT IS CONDUCTED IN THE U.S. WITH SOME EXCEPTIONS. THE OTHER RULE IS OUR INSTITUTIONAL REVIEW BOARD AND HUMAN SUBJECTS PROTECTION RULE. AND THIS PROPOSED RULE IF FINALIZED WOULD GO TO HUMAN PROTECTION REGULATIONS RELATED TO REQUIREMENTS FOR IRBs AND INFORMED CONSENT AGAIN, TO THE EXTENT PRACTICABLE AND IN ACCORDANCE WITH THE CURES ACT. AND AS NOTED, THE PROPOSED RULE WOULD UPDATE PARTS OF OURING REGULATION AND INTENDED TO MODERNIZE AND SIMPLIFY OVERSIGHT OF FDA REGULATED CLINICAL INVESTIGATIONS. THIS PROPOSED RULE DOESN'T INCLUDE ALL COMMON RULE PROVISIONS BASED ON THE PRIORITIZATION I JUST NOTED. AS WELL AS CONSIDERING OTHER CHANGES FOR PRACTICABLE AND CONSISTENT WITH OTHER STATUTORY PROVISIONS. WE HAVE ADDRESSED SOME PROVISIONS IN OUR PRIOR PROPOSED RULE ON IRB WAIVER AND ALSO IN THE COOPERATIVE RESEARCH PROPOSED RULE THAT WE'LL BE DISCUSSING SHORTLY. AND AS NOTED IN THE PREAMBLE, WE ARE CONSIDERING HOW OTHER PROVISIONS OF THE REVISED COMMON RULE POTENTIALLY APPLICABLE AND RELEVANT TO FDA REGULATED RESEARCH SUCH AS POSTING INFORMED CONSENT, EXEMPT RESEARCH AND PUBLIC HEALTH SURVEILLANCE ACTIVITIES WOULD BE APPLIED TO THE TYPE OF RESEARCH WE REGULATE. THE OTHER NOTE I'LL HAVE AND I WON'T WALK THROUGH EVERY PROPOSED CHANGE -- INDIVIDUAL CHANGE TODAY, BUT WE'LL FOCUS PRIMARILY ON HIGHLIGHTING KEY ONES AND IDENTIFYING WHERE YOU CAN GET INFORMATION, FIND INFORMATION ON THE OTHER CHANGES. SO LET ME START WITH CHANGES RELATED TO INFORMED CONSENT. SO IN THE RULE, WE PROPOSED TO ADOPT COMMON RULE PROVISIONS THAT WE BELIEVE CAN BETTER FACILITATE POTENTIAL PARTICIPANTS IN MAKING DECISIONS ABOUT WHETHER A PARTICULAR TRIAL IS APPROPRIATE FOR THEM. THESE CHANGES ARE INTENDED TO STRENGTHEN THE EFFECTIVENESS OF OUR HUMAN SUBJECTS PROTECTIONS REGULATIONS. FOR EXAMPLE, WE ARE PROPOSING CHANGES TO THE CONTENT, THE ORGANIZATION AND PRESENTATION OF INFORMATION INCLUDED IN BOTH THE INFORMED CONSENT FORM AND THE PROCESS. AND I THINK THIS IS BEST EXEMPLIFIED BY OUR PROPOSAL TO INCLUDE THE REVISED COMMON RULES, KEY INFORMATION REQUIREMENT FOR INFORMED CONSENT TO OVER ALL THE INTENT IS FOR THE PRESENTATION OF INFORMATION TO BE IN THE INFORMED CONSENT DOCUMENT AND PROCESS TO BE IN AN UNDERSTANDABLE AND ORGANIZED MANNER. OTHER PROPOSED ENHANCEMENTS TO OUR INFORMED CONSENT PROCESS INCLUDE A NEW BASIC ELEMENT OF INFORMED CONSENT AND THREE NEW ADDITIONAL ELEMENTS TO BE INCLUDED WHERE RELEVANT. THESE THREE ELEMENTS MIRROR ADDITIONS MADE TO THE COMMON RULE. THE FIRST IS A STATEMENT TO BIO INFORMATION OR BIO SPECIMENS COLLECTED DURING RESEARCH MAY BE USED FOR COMMERCIAL PROFIT AND WHETHER THE SUBJECT WILL OR WILL NOT SHARE IN THIS COMMERCIAL PROFIT. NEXT SAY STATEMENT ON WHETHER CLINICALLY RELEVANT RESEARCH RESULTS INCLUDING INDIVIDUAL RESEARCH RESULTS WILL BE PROVIDED TO PARTICIPANTS AND IF SO UNDER WHAT CONDITIONS. FINALLY, THE THIRD PROPOSED ELEMENT PERTAINS TO RESEARCH INVOLVING BIO SPECIMENS AND WOULD REQUIRE THAT SUBJECTS BE INFORMED WHETHER THE RESEARCH WILL IF KNOWN OR MIGHT INCLUDE WHOLE GENOME SEQUENCING. THOSE ARE THE THREE ADDITIONAL ELEMENTS I MENTIONED AND ADDITIONAL MANDATORY ELEMENTS WE ARE PROPOSING AND WE ARE ALSO PROPOSING TO HARMONIZE WITH THE REVISED COMMON RULE BY ADDING A NEW MANDATORY ELEMENT OF INFORMED CONSENT THAT ENCOMPASSES THE STATEMENT REQUIRED BY THE COMMON RULE. AND UNDERSTAND THE COMMON RULE THAT IS EITHER A STATEMENT THAT IDENTIFIERS MAY BE REMOVED FROM IENTIFIABLE PRIVATE INFORMATION OR IDENTIFIABLE BIO SPECIMENS AND THE INFORMATION OR BIO SPECIMENS MAY BE USED FOR FUTURE RESEARCH STUDIES OR DISTRIBUTED TO ANOTHER INVESTIGATOR FOR FUTURE RESEARCH STUDIES WITHOUT OBTAINED INFORMED CONSENT OR LEGAL REPRESENTATIVE FROM A POSSIBILITY AND ALTERNATIVE THE SUBJECT'S INFORMATION OR BIO SPECIMENS EVEN IF IDENTIFIERS ARE REMOVED WILL NOT BE USED OR DISTRIBUTED FOR FUTURE RESEARCH. THE ELEMENT IN OUR PROPOSED RULE WOULD REQUIRE A DESCRIPTION OF HOW INFORMATION FOR BIO SPECIMENS MAY BE USED FOR RESEARCH OR DISTRIBUTED TO ANOTHER INVESTIGATOR FOR FUTURE RESEARCH THIS PROPOSAL IS REALLY INTENDED TO INCORPORATE FLEXIBILITY AS TO THE DESCRIPTION THAT AN INVESTIGATOR WOULD PROVIDE TO EACH POTENTIAL SUBJECT OR THEIR LEGALLY AUTHORIZED REPRESENTATIVE TO HAVE ENSURE THAT THEY'RE INFORMED REGARDING POSSIBLE FUTURE USES OF BIO SPECIMENS FROM COLLECTED IN RESEARCH AND WE THINK THIS FLEXIBILITY IS NEEDED IN THE WAYS IN WHICH INFORMATION AND BIO SPECIMEN USED RELEVANT TO FDA REGULATED PRODUCT CONTINUES TO EVOLVE AND THE DESCRIPTION OF HOW INFORMATION AND BIO SPECIMENS MAY BE USED FOR FUTURE RESEARCH OR DISTRIBUTED TO ANOTHER INVESTIGATOR FOR SUCH RESEARCH WILL HELP POTENTIAL PARTICIPANTS TO IDENTIFY THE TYPES OF PLANNED FUTURE RESEARCH USING THEIR INFORMATION OR USING THEIR BIO SPECIMENS THEY MAY DEEM OBJECTIONABLE IDENTIFYING THAT FUTURE POTENTIAL MAY UNKNOWN. WHILE FDA'S PROPOSED ELEMENT IS NOT LIMITED TO THE TWO SITUATIONS ADDRESSED BY THE STATEMENTS UNDER THE CORRESPONDING ELEMENT IN THE COMMON RULE, WE THINK THE RESEARCH COMMUNITY WOULD BE ABLE TO DEVELOP INFORMED CONSENT FORMS AND PROCESSES THAT COMPLY WITH BOTH SETS OF REGULATIONS. WHEN APPLICABLE, AN INVESTIGATOR WOULD BE REQUIRED TO PROVIDE A DESCRIPTION THAT CAN INFORM OF THE FUTURE USE OF BIO SPECIMENS OR INFORMATION THAT MAY NOT BE STRIPPED OF IDENTIFIERS. NJS NONETHELESS WE HAVE A COMMENT WHETHER OUR INFORMED CONSENT WOULD PROVIDE ADEQUATE NOTICE TO REGARDING POTENTIAL FUTURE USE OF A PARTICIPANT'S INFORMATION OR BIO SPECIMENS OR WHETHER THE PROVISION IN THE COMMON RULE WOULD BETTER INFORM POTENTIAL PARTICIPANTS ABOUT SUCH POSSIBLE FUTURE USES. LASTLY, RELATED TO INFORMED CONSENT, IN PART 56, WE DO PROPOSE TO AT THE COMMON RULES PROTECTS OF INFORMED CONSENT WHEN A STUDY PRESENTS NO MORE THAN MINIMAL RISK AND THE SUBJECTS OR THEIR L.A.R.s ARE MEMBERS OF A DISTINCT CULTURAL GROUP OR COMMUNITY WHERE SIGNING FORM IS NOT THE NORM AND THERE'S AN APPROPRIATE ALTERNATIVE MECHANISM FOR DOCUMENTING THAT INFORMED CONSENT WAS OBTAINED. THOSE ARE SOME OF THE KEY CHANGES TO INFORMED CONSENT AND WE'RE PROPOSING NEW AND REVISED DEFINITIONS WITH THE COMMON RULE AND THIS INCLUDES THREE NEW DEFINITI DEFINITIONS IDENTIFIABLE INFORMATION AND BIO SPECIMENS AND THINK THE DEFINITIONS ARE IMPORTANT TO MODERNIZE OUR REGULATIONS AND REFLECT THE CHANGING RESEARCH LANDSCAPE THAT INVOLVES VAST AMOUNT OF DATA THROUGH ELECTRONIC HEALTH RECORD OR THE DEVELOPMENT OF NEW TECHNOLOGY AND CAPABILITIES ADVANCING SCIENCE. AND THERE'S BEHAVIOR IN WHICH AN INDIVIDUAL CAN REASONABLY EXPECT THAT NO OBSERVATION FOR REPORTING IS TAKING PLACE AND THAT INFORMATION HAS BEEN PROVIDED FOR A SPECIFIC PURPOSE BY THAT INDIVIDUAL AND THEY CAN REASONABLY EXPECT WILL NOT BE MADE PUBLIC. FOR EXAMPLE, A MEDICAL RECORD. THERE'S IDENTIFIABLE PRIVATE INFORMATION AND IDENTIFIABLE BIO SPECIMENS IS THAT WE PROPOSE TO ADD SPONSORS IN ADDITION TO INVESTIGATORS AS PARTIES WHO MAY REASONABLY OR READILY ASCERTAIN INFORMATION OR THE IDENTITY OF THE SUBJECT. THESE TERMS SPONSOR INVESTIGATORS ARE USED THROUGHOUT OUR REGULATIONS TO DESCRIBE DIFFERENT RESPONSIBILITIES OF DISTINCT PARTIES INVOLVED IN FDA REGULATED RESEARCH. THOSE ARE THE THREE NEW DEFINITIONS. IN ADDITION TO THESE WE ALSO PROPOSE TO REVISE DEFINITIONS AGAIN IN THE SPIRIT OF THE MODERNIZATION AND HARMONIZATION, FOR EXAMPLE, PROPOSING A DEFINITION OF WRITTEN OR IN WRITING THAT INCLUDES BOTH PHYSICAL AND ELECTRONIC FORMATS. FINALLY, WE ARE PROPOSING TO HARMONIZE OUR DEFINITION OF LEGALLY AUTHORIZED REPRESENTATIVE WITH THAT IN THE COMMON RULE BY ADDRESSING SCENARIOS IN WHICH THERE IS NO APPLICABLE LAW THAT APPLIES. BEFORE I MOVE ON TO TALK ABOUT A KEY CHANGE TO PART 56 AND CONTINUING REVIEW REQUIREMENTS, I WANTED TO HIGHLIGHT THAT THERE ARE A NUMBER OF OTHER PROPOSED CHANGES THAT ARE INTENDED TO HARMONIZE WITH THE COMMON RULE. AND IN THE PREAMBLE TO OUR RULES, TABLE 1 OUTLINES THE PROPOSED CHANGES TO PART 50 AND TABLE 3 SUMMARIZES THOSE WITH PART 56. FOR EXAMPLE, WE PROPOSE TO ADD REFERENCE IN MULTIPLE PLACES TO TRIBAL LAW OF AMERICAN INDIAN OR ALASKAN NATIVE TRIBES TO REFERENCE FEDERAL, STATE OR LOCAL LAW INTENDED TO ALSO INCLUDE TRIBAL LAW. WE ALSO PROPOSE TO ALIGN WITH THE COMMON RULE THE IRB MEMBERSHIP AND WE REQUIRE A MEMBERSHIP TO REFLECT A DIVERSITY OF PROFESSIONAL QUALIFICATIONS AND OTHER FACTORS SUCH AS RACE, GENDER AND CULTURAL BACKGROUND. FINALLY, WE PROPOSE TO MAKE MINOR CHANGES TO THE DESCRIPTION OF CATEGORIES OF SUBJECTS WHO ARE CONSIDERED VULNERABLE OR UNDER UNDUE INFLUENCE. AGAIN, ADOPTING THE LANGUAGE FROM THE COMMON RULE. I ENCOURAGE YOU TO LOOK AT THE TABLE TO SEE THE OTHER CHANGES WE'RE PROPOSING. LET ME MOVE ON TO TALK ABOUT CONTINUING REVIEW IN PART 56. LIKE THE COMMON RULE, WE PROPOSE TO ADD A PROVISION THAT WOULD ALLOW IRBs TO ELIMINATE CONTINUING REVIEW OF RESEARCH UNLESS THE IRB DETERMINES OTHERWISE. FOR RESEARCH THAT HAS PROGRESSED TO THE POINT WHERE IT ONLY INVOLVES DATA ANALYSIS INCLUDING ANALYSIS OF IDENTIFIABLE PRIVATE INFORMATION OR ACCESSING FOLLOW-UP CLINICAL DATA FROM PROCEDURES PARTICIPANTS WOULD UNDER GO AS PART OF CLINICAL CARE. FOR EXAMPLE, LONG-TERM FOLLOW-UP USING DATA AFTER STUDIES WERE COMPLETED. THESE CHANGES ARE ONES THAT ARE INTENDED TO ALLOW IRB'S TO FOCUS THEIR RESOURCES OR THE RESEARCH THAT PRESENTS HIGHER RISK AND RELATED TO THIS CHANGE WE'RE ALSO PROPOSING TO ADD LANGUAGE THAT WOULD REQUIRE AN IRB TO DOCUMENT THE RATIONALE FOR CONDUCTING CONTINUING REVIEW TO THE EXTENT THEY DETERMINE CONTINUING REVIEW WOULD BE NECESSARY WHEN IT WOULDN'T OTHERWISE BE REQUIRED. AND THE LAST CHANGE IS THAT WE PROPOSE TO REVISE EXISTING REQUIREMENTS IN OUR DEVICE I.D.E. REGULATIONS TO ALIGN WITH OUR CHANGES IN CONSUMER REVIEW, THAT IS TO CLARIFY THAT PROGRESS REPORTS SUBMITTED BY A CLINICAL INVESTIGATOR TO THEIR IRB MUST BE SUBMITTED TO THE EXTENT THAT CONTINUING REVIEW IS REQUIRED BY PART 56. I WILL NOTE TWO ADDITIONAL EXCEPTIONS IN THE COMMON RULE WE DON'T PROPOSE TO ADOPT AT THIS TIME. ONE IS AN EXCEPTION THAT WOULD ELIMINATE CONTINUING REVIEW FOR THE CURRENT LIST OF RESEARCH QUALIFYING FOR EXPEDITED REVIEW AND THE OTHER EXCEPTION IN THE COMMON RULE IS FOR RESEARCH REVIEWED BY THE IRB IN ACCORD WITH LIMITED REVIEW WHICH WE ARE ALSO NOT PROPOSING TO ADOPT IN THIS RULE AS IT IMPLICATES OTHER REVISED COMMON RULE PROVISIONS WE DON'T PROPOSE TO ADOPT IN THIS RULE MAKING. WE'LL CONTINUE TO EVALUATE AND TO EXPLORE FURTHER OPPORTUNITIES FOR HARMONIZATION AND IN THE PREAMBLE TO THIS RULE WE DO HIGHLIGHT AND IDENTIFY PROVISIONS IN THE REVISED COMMON RULE THAT ARE NOT INCLUDED IN OUR PROPOSED RULE BUT UNDER FURTHER CONSIDERATION. SO WITH THAT, I'D LIKE TO TURN NOW TO THE COOPERATIVE RESEARCH PROPOSED RULE. THIS PROPOSED RULE IF FINALIZED WOULD RELY -- WOULD REPLACE CURRENT FDA REQUIREMENTS FOR COOPERATIVE RESEARCH AND REQUIRE ANY INSTITUTION LOCATED IN THE UNITED STATES PARTING IN FDA REGULATED COOPERATIVE RESEARCH TO ARELY ON APPROVAL FOR THE PORTION OF RESEARCH CONDUCTED IN THE UNITED STATES WITH SOME REFLECTIONS FOR WHICH REQUIRING THE USE OF A SINGLE IRB FOR OVERSIGHT OF THIS MULTI-SITE RESEARCH MAY NOT BE APPROPRIATE FOR FDA REGULATED TRIALS. WE'RE PROPOSING THESE REVISIONS TO STREAMLINE THE IRB REVIEW PROCESS AND TO DECREASE ADMINISTRATIVE BURDEN ARE REDUCING INEFFICIENCIES FOR INVESTIGATORS AND IRBs WITHOUT COMPROMISING HUMAN SUBJECTS PROTECTION. WE AGREE WITH THE COMMON RULE DEPARTMENTS AND AGENCIES THAT THE BENEFITS OF SINGLE IRB REVIEW INCLUDING THAT STREAMLINE REVIEW PROCESS AND THE REDUCTION ADMINISTRATIVE BURDEN AND INCREASED EFFICIENCIES ARE UNLIKELY TO BE REALIZED IF ARE RELIANCE ON A SINGLE IRB FOR REVIEW OF MULTI-SITE RESEARCH REMAINS VOLUNTARY. THAT SAID, WE DON'T BELIEVE THAT THE BENEFITS MUCH SINGLE IRB REVIEW OUTWEIGH THE POTENTIAL ASSOCIATED BURDEN IN EVERY CIRCUMSTANCE. BECAUSE OF THAT WE ARE PROPOSING SPECIFIC EXCEPTIONS THAT AGAIN WE THINK REFLECT CIRCUMSTANCES WHERE IT MAY NOT BE APPROPRIATE OR MAY NOT YIELD ANTICIPATED EFFICIENCIES FOR THE RESEARCH WE REGULATE. WITH THAT BACKGROUND IN MIND, I THOUGHT IT MIGHT BE BENEFICIAL TO TALK THROUGH THE FOUR EXCEPTIONS IN OUR PROPOSED RULE. THE FIRST PROPOSED EXCEPTION TO THE REQUIREMENT FOR SINGLE IRB REVIEW IS IDENTICAL TO THAT IN THE REVISED COMMON RULE. IT PROVIDES FOR AN EXCEPTION IF MORE THAN A SINGLE IRB IS REQUIRED BY LAW INCLUDING TRIBAL LAW PASSED BY THE OFFICIAL GOVERNING BODY OF AN AMERICAN INDIAN OR ALASKAN NATIVE TRIBE. THE SECOND RELATES TO COOPERATIVE RESEARCH INVOLVING A HIGHLY SPECIALIZED FDA REGULATED MEDICAL PRODUCT SUCH AS A DEVICE REQUIRING A HIGHLY SPECIALIZED SURGICAL TRAINING. SO EXPERTISE FOR THESE UNIQUE PRODUCTS IS OFTEN LIMITED TO ONLY A FEW SPECIALISTS ACROSS THE COUNTRY AT SITES WHERE THE LOCAL IRB MAY BE ABLE TO SERVE AS A SINGLE IRB OF RECORD AND MANDATING THE USE OF SINGLE IRB REVIEW COULD BE AN OBSTACLE TO INITIATING IMPORTANT RESEARCH WHEN THE LOCALIZED EXPERTISE TO CONDUCT THE TRIAL IS RARELY AVAILABLE BUT NONE OF THE IRBs ASSOCIATED WITH THE INVESTIGATIONAL SITE HAVE THE OPERATIONAL CAPACITY TO SERVE AS A SINGLE IRB OF RECORD. THAT'S THE SECOND EXCEPTION. THE THIRD AND FOURTH PROPOSED EXCEPTIONS CAPTURE FDA REGULATED DRUG AND DEVICE STUDIES THAT DO NOT REQUIRE AN I.N.D. OR I.D.E. SUBMISSION TO FDA. STUDIES WITHIN THESE PROPOSED EXCEPTIONS ARE RESEARCH INVOLVING DRUGS OR DEVICES THAT ARE ALREADY LAWFULLY MARKETED AND THAT ARE NOT BEING CONDUCTED FOR THE PURPOSES OF SUPPORTING A NEW PRODUCT CLEARANCE OR APPROVAL. THESE ARE GENERALLY LOWER RISK STUDIES AND WE THINK THE VOLUME OF IRB ACTIVITY WILL BE LOW SUCH THAT THE EFFICIENCIES OF SINGLE IRB MAY NOT BE REALIZED. SO WE HAVE SOME -- THOSE ARE THE PROPOSED EXCEPTIONS. IF I LOOK AT THE EXCEPTIONS IN THE COMMON RULE THOUGH THIS PROPOSED RULE WOULD HARMONIZE THAT REQUIREMENT FOR COOPERATIVE RESEARCH TO THE EXTENT PRACTICABLE WITH THE COMMON RULE THERE ARE SOME ASPECTS THAT ARE NECESSARILY DIFFERENT FROM THE REVIVED COMMON RULE DUE TO THE DIFFERENT SCOPE OF RESEARCH WE REGULATE. ONE NOTABLE DIFFERENCE IS THE INCLUSION OF SPECIFIC EXCEPTIONS THAT WE JUST WALKED THROUGH FOR TO THE REQUIREMENT FOR THE USE OF THE SINGLE IRB RATHER THAN THE BROAD EXCEPTION IN THE REVISED COMMON RULE FOR RESEARCH FOR WHICH ANY FEDERAL DEPARTMENT OR AGENCY SUPPORTING OR CONDUCTING THE RESEARCH DETERMINING AND DOCUMENT THE SINGLE USE OF IRB IS NOT APPROPRIATE FOR THAT PARTICULAR CONTEXT. AS WE LOOKED AT THIS BECAUSE MOST THE RESEARCH THE FDA REGULATES IS NOT SUPPORTED BY FDA OR BY ANOTHER FEDERAL DEPARTMENT OR AGENCY. IT APPLY TO FDA INVESTIGATIONS. WE BELIEVE IT WOULD BE IMPRACTICABLE TO ADOPT AN ANALOGOUS EXCEPTION FOR OCCASION WHERE'S A SINGLE IRB IS NOT APPROPRIATE FOR THE PARTICULAR CONTEXT. AS WE TALKED ABOUT IN THE PREAMBLE CERTAIN FDA RESEARCH DOES NOT REQUIRE A SUBMISSION TO FDA OR OTHER INTERACTION WITH THE AGENCY BEFORE IT BEGINS AND IF WE WERE TO REQUIRE THAT SUCH RESEARCH HAD TO OBTAIN FDA'S DETERMINATION AND DOCUMENTATION THAT SINGLE IRB REVIEW IS NOT APPROPRIATE, IT CAN ADD TO THE ARE WHICH WE THINK ARE CON TERRY TO THE PROPOSED -- CONTRARY TO THE PROPOSED RULE AND THE SINGLE IRB REQUIREMENT DIFFERENCE IS THAT FDA IS NOT PROPOSING TO REQUIRE THE REVIEWING IRB BE IDENTIFIED BY THE FEDERAL DEPARTMENT OR AGENCY SUPPORTING OR CONDUCTING THE RESEARCH OR BY THE LEAD INSTITUTION SUBJECT TO ACCEPTANCE BY A FEDERAL DEPARTMENT OR AGENCY SUPPORTING THE RESEARCH. IT'S NOT PRACTICABLE FOR US TO ADOPT THAT REQUIREMENT BECAUSE UNLIKE RESEARCH SUBJECT TO THE REVISED COMMON RULE AS JUST MENTIONED MUCH OF THE RESEARCH, MOST OF THE RESEARCH WE REGULATE IS NOT CONDUCTED OR SUPPORTED BY FDA OR ANY DEPARTMENT OR AGENCY. AND OUR REGULATION DOES NOT REQUIRE A CERTAIN RESOLUTION WHEN A SINGLE IRB IS USED AND UNAWARE OF DIFFICULTIES IN SELECTING WHAT WARRANT REQUIRING THAT A SINGLE IRB ALWAYS BE IDENTIFIED BY A PARTICULAR PARTY FOR ALL FDA REGULATED RESEARCH AND WE DON'T SEE THAT THERE'S A POTENTIAL FOR CONFLICT FOR RESEARCH CONFLICT TO THOSE RULES. WE DO REQUEST PUBLIC COMMENT IN A NUMBER OF AREAS SO WE REQUEST PUBLIC COMMENT ON THE EXCEPTIONS WE PROPOSED AS WELL AS TWO OTHER POTENTIAL EXCEPTIONS TO THE SINGLE IRB REQUIREMENT FOR COOPERATIVE RESEARCH. IN PARTICULAR, WE'RE SEEKING STAKEHOLDER FEEDBACK ON WHETHER AN EXCEPTION IS APPROPRIATE WHEN IT'S UNABLE TO MEET THE NEEDS OF A SPECIFIC POPULATION. THIS EXCEPTION MIGHT APPLY TO RESEARCH THAT INVOLVES RECRUITING MEMBERS OF A DISTINCT COMMUNITY OR POPULATION WHERE THE LOCAL PERSPECTIVE IS PARTICULARLY IMPORTANT AND IF THE SINGLE -- PARTICULARLY IF THE SINGLE IRB IS UNABLE TO OBTAIN SUFFICIENT SUPPLEMENTAL INFORMATION TO CONSIDER THAT COMMUNITY'S NEEDS. AND REQUESTING WHETHER A SINGLE IRB OF RECORD IS GENERALLY ABLE TO SUPPLEMENT THE MEMBER'S KNOWLEDGE AND EXPERIENCE WITH ADDITIONAL INFORMATION OR WITH ADDITIONAL EXPERTISE TO ACCOUNT FOR THESE KINDS OF SITUATIONS AND WE'RE ALSO ASKING FOR EXAMPLES OF FDA REGULATED RESEARCH FOR WHICH PEOPLE MIGHT ENVISION THE CIRCUMSTANCES WOULD APPLY AND ANY DATA ON THE FREQUENCY OF HOW OFTEN THE SITUATION MIGHT OCCUR. ANOTHER POTENTIAL EXCEPTION THAT WE'RE SEEKING STAKEHOLDER INPUT ON IS WHETHER AN EXCEPTION IS APPROPRIATE TO THE SINGLE IRB REQUIREMENT FOR A MULTI-SITE STUDY WHERE THERE ARE A SMALL NUMBER OF SITES AND WHAT'S THE APPROPRIATE THRESHOLD FOR THE NUMBER OF SITES IT SHOULD BE. WE REQUEST FEEDBACK ON THE BENEFITS AND BURDENS FOR MULTI-SITE STUDIES THAT HAVE A SMALL NUMBER OF SITES AND SPECIFIC DATA THAT COULD BE PROVIDED IN THE RELATIONSHIP BETWEEN THE NUMBER OF SITES AND THE VALUE OF SINGLE IRB REVIEW. AND LASTLY, WE'RE REQUESTING EXAMPLES IN ANY ADDITIONAL TYPES OF FDA-REGULATED CLINICAL INVESTIGATIONS THAT MAY BENEFIT FROM AN EXCEPTION AS WELL FEEDBACK ON ANY CRITERIA THAT SHOULD BE CONSIDERED WHEN ASSESSING WHETHER AN EXCEPTION TO THE USE OF SINGLE IRB REVIEW MAY BE WARRANTED. THE LAST AREA THAT WE ARE REQUESTING COMMENT IS BECAUSE WE RECOGNIZE THAT SOME FDA REGULATED COOPERATIVE RESEARCH IS ALSO SUBJECT TO THE COMMON RULE. DEF WHAT IS EXCEPTIONS >>WITH EXCEPTIONS TO COMMON RULE AGENCIES. WE BELIEVE THE PROPOSED EXCEPTIONS THAT WE HAVE WOULD MOST LIKELY COVER MOST OF THE SITUATI SITUATIONS FOR THE RESEARCH SUBJECT TO THE REGULATIONS. NEVERTHELESS WE DO REQUEST COMMENT IN THE PREAMBLE ON ANY IMPACT DIFFERENCES BETWEEN FDA'S PROPOSED EXCEPTIONS FOR SINGLE IRB AND EXCEPTION DETERMINATIONS ISSUED BY COMMON RULE DEPARTMENT OR AGENCY MAY HAVE FOR STAKEHOLDERS AND REQUEST COMMENT ON POSSIBLE APPROACHES TO MINIMIZE ANY POTENTIAL NEGATIVE AFFECTS ON THE EXCEPTIONS FROM A SINGLE IRB REVIEW REQUIREMENT AND WE'RE INTERESTED IN UNDERSTANDING WHETHER THERE'S UNIQUE CHALLENGES TO USE OF A SINGLE IRB REVIEW MODEL FOR FDA-REGULATED COOPERATIVE RESEARCH THAT COULD BE NOT BE ADDRESSED BY FDA'S PROPOSED EXCEPTIONS AND LASTLY, WE REQUEST COMMENT ON WHETHER FDA SHOULD INCLUDE AN EXCEPTION FOR FDA DETERMINED AND DOCUMENT SINGLE IRB REVIEW IS NOT APPROPRIATE FOR ANY PARTICULAR CONTEXT. THAT'S A QUICK OVERVIEW OF BOTH RULES. I WANT TO THANK FOR THE OPPORTUNITY TO SPEAK TO THEM AND ALSO KIND OF REMIND ALL OF US THE PUBLIC COMMENT PERIOD FOR THE PROPOSED RULES IS OPEN THROUGH NOVEMBER 28. I'M HANDING IT BACK TO YOU, DOUG. >>THANK YOU FOR THE OVERVIEW AND THE DEADLINE FOR COMMENT IS NOVEMBER AND WHAT THAT MEANS FOR OUR COMMITTEE IS THAT AND FINALIZE RECOMMENDATIONS IN THE NEXT COUPLE DAYS SINCE THESE ARE OUR ONLY MEETINGS BETWEEN NOW AND WHEN COMMENTS ARE DUE. BEFORE WE TURN THIS TO MARK BARNES, ARE THERE ANY QUESTIONS FROM COMMITTEE MEMBERS FOR ANN ABOUT THE PROPOSED RULE ITSELF. SEEING NONE WE'LL BEGIN WITH OUR DISCUSSION AND WE'LL START WITH THE SECOND OF THESE PROPOSED RULES THE ONE RELATED TO COOPERATIVE RESEARCH AND MARK BARNES YOU'RE GOING TO TAKE US THROUGH WHAT THE SUBCOMMITTEE HAS PROPOSED AS SACHRP'S RECOMMENDATIONS RELATED TO THE PROPOSED RULES. >>BEFORE MARK GETS STARTED I WANTED TO TAKE A MOMENT AND REMIND ANYONE IN THE AUDIENCE ALL THE DOCUMENTS FOR TODAY'S MEETING AND FOR TOMORROW'S MEETING ARE AVAILABLE AT REGULATIONS.gov AT THE FOLLOWING DOCKET NUMBER, DOCKET IS HHS-OASH-2022-0016. THANK YOU. >>AND IF YOU ARE FOLLOWING ALONG IN THE FEDERAL REGISTER THIS IS AT 58752. THAT'S THE PAGE NUMBER IT STARTS AT. MARK, IT'S ALL YOURS. >>THANK YOU, DOUG AND JULIA AND ANN. ONE THING TO SAY OBVIOUSLY IS THANK YOU TO FDA FOR LABORING ON AND SOLDIERING ON AND GETTING US TO THE POINT OF TRYING TO HARMONIZE THESE REGULATIONS. SACHRP OVER THE YEARS HAS HAD A NUMBER OF COMMENTS ABOUT THE VARIOUS PROPOSALS FIRST FROM NIH AND LATER FROM THE REVISED COMMON RULE ABOUT THE USE OF SINGLE OR CENTRAL IRBs. WE'LL CALL THEM SINGLE IRBs FOR THE PURPOSE OF DISCUSSION TODAY. AND THE SUBCOMMITTEES HAVE MET ABOUT THE FDA PROPOSAL AND HAD A NUMBER OF CONVERSATIONS ABOUT THEM IN GROUP FORMATS BETWEEN THE SUBCOMMITTEES AND HRP STAFF AND WE HAVE A DOCUMENT. JULIA, DO YOU WANT TO PULL UP THE DOCUMENT ON THE SCREEN? IS THAT OKAY? SORRY, I DIDN'T KNOW I WOULD BE DOING THAT FOR YOU. >>I CAN DO IT. IT WILL TAKE ME A MINUTE. >>I'LL HAVE TO CALL IT UP. >>I GET QUITE CONFUSED ABOUT THIS SCREEN SHARING BUSINESS. >>I CAN DO IT FOR YOU BUT SOMETIMES IT'S MORE HELPFUL WITH THE SPEAKER DOING IT. THOUGH IT'S PROBABLY SMALL. >>CAN YOU MAKE IT LARGER? >>THAT'S GOING TO BE INTERESTING. THANK YOU. MAKE IT 100 AND YOU CAN COLLAPSE THE SCREEN BY HITTING THE MIDDLE IN THE TAKE YOUR CURSER DOWN FROM WHERE IT IS. THERE YOU GO. SO LARGELY, WE HAVE COMMENTS AND WE PUT TOGETHER -- THE WAY THE DOCUMENT IS ORGANIZED, WE PUT TOGETHER THE SPECIFIC REQUESTS THAT EACH SPECIFIC REQUEST THAT FDA MADE IN SECTIONS ABOUT THE SINGLE IRB REQUIREMENT FOR TREATMENT OF SINGLE IRB APPROACH AND THEN WE HAVE PROPOSED A COMMENT TO EACH OF THOSE REQUESTS FOR COMMENT FROM FDA. AND ALL OF THESE ONE OF OUR GOALS WAS TO MAKE OUR APPROACH TO RESPONDING TO FDA THAT WE'RE RECOMMENDING TO SACHRP CONSISTENT WITH THE PREVIOUS WORK OF SACHRP ON THE SAME ISSUES. I THINK WHAT YOU'LL FIND IS THAT THIS IS NOT FOR BREAKING NEW GROUND, THIS IS REITERATING AND MAYBE ADDING A BIT TO PREVIOUS RESPONSE TO WHAT HAS BEEN DONE OVER THE YEARS. LET ME STOP AND SEE IF THERE'S QUESTIONS FROM SACHRP MEMBERS BEFORE I GO FORWARD. THE INTRODUCTION IS ABOUT THE BACKGROUND ON THE SINGLE IRB ISSUES. THERE'S 10 OR 11 SPECIFIC REQUESTS WE WERE ABLE TO IDENTIFY FROM THE TEXT OF FDA'S PROPOSED RULE AND THE INTRODUCTION OR DESCRIPTION OF THE RULE THAT FDA OFFERED. THE FIRST IS FDA'S REQUESTING COMMENT ON WHETHER IT'S APPROPRIATE TO INCLUDE AN EXCEPTION FOR COOPERATIVE RESEARCH WHEN USE OF A SINGLE IRB IS UNABLE TO MEET THE NEEDS OF SPECIFIC POPULATIONS. I'M IN THE GOING READ THE ROUGH TEXT BUT BASICALLY SACHRP AND WHAT WE'RE COMMENDING AS SUBCOMMITTEES IS THAT, YES, THERE SHOULD BE AN EXCEPTION FOR COOPERATIVE RESEARCH FOR WHICH A SINGLE IRB IS UNABLE TO MEET THE NEEDS OF SPECIFIC POPULATIONS AND IN CRAFTING OR IN CRAFTING THE GUIDING DOCUMENT THAT WOULD INTRODUCE THE FINAL RULE ON THIS ISSUE THAT IT SHOULD BE A HIGH STANDARD SO THAT THE EXCEPTION DOES NOT ESSENTIALLY EAT THE RULE AND PRESUMPTION IN FAVOR OF USING A CENTRAL IRB. WE TALKED ABOUT THE FACT THAT USING A LOCAL IRB IS OFTEN IMPORTANT WHEN THERE ARE SPECIFIC POPULATIONS AND WHERE A SINGLE IRB WOULD NOT BE NECESSARILY TO UNDERSTAND, APPRECIATE AND REFINE A PROTOCOL TO PROTECT THE POPULATIONS AND THERE ARE PARTICULAR ISSUES THAT ARE EMBEDDED IN AN IRBs CONSIDERATION AND APPROVAL OF A PROTOCOL THAT ARE ABOUT LOCAL ETHICS AND LOCAL STANDARDS AND SO WE GIVE EXAMPLES HERE. WE ALSO NOTE THAT ACCORDING TO THE COMMON RULES APPROACH, THE COMMON RULE ALREADY IN ITS REVISED FORM ALREADY SAID THE APPLICATION OF THE SINGLE IRB IS ONLY APPLICABLE TO SITES IN THE U.S. AND THEN THERE'S AN EXCEPTION FOR ESSENTIALLY TRIBAL LAW AND THOSE REALLY ARE -- THOSE EXCEPTIONS EVEN EMBEDDED IN THE REVISED COMMON RULE ARE REFLECTIVE OF THE FACT THAT THERE ARE ABOUT THE FACT THAT THERE ARE LOCAL SITUATIONS IN WHICH AND IN THE CASE OF AMERICAN INDIAN ALASKAN NATIVE TRIBAL ORGANIZATIONS WHERE THERE SHOULD BE DEFERRAL TO LOCAL VALUES AND THE LOCAL VALUES ARE NOT NECESSARILY ABLE TO BE COMPREHENDED AND VINDICATED BY A SINGLE IRB REVIEW. WE RECOMMEND THIS AND I GUESS I'LL STOP THERE. I WOULD SAY THIS, I THINK THIS IS -- AND DAVID BORASKI WHO HELPED ME WITH THIS RESPONSE AND FEEL FREE TO ADD ON AND INTERRUPT AND SO SHOULD MICHELE AND DAVID FORSTER WHO WERE SUBCOMMITTEE CO-CHAIRS BUT I THINK IT'S FAIR TO SAY MANY OF US IN THE SUBCOMMITTEES AND MANY IN THE ACADEMIC RESEARCH COMMUNITY, FRANKLY, WE HAVE BEEN OVER THE YEARS SOMEWHAT SUSPICIOUS OF A SINGLE IRB REQUIREMENT INVARIABLE AND DOES NOT HAVE EXCEPTIONS BECAUSE WE HAVE SEEN IN OUR EXPERIENCES THAT LOCAL IRB REVIEW IN MANY CASES ACTUALLY IS EXTREMELY HELPFUL AND IMPORTANT AND SO I THINK THAT SACHRP'S HISTORICAL POSITIONS REFLECT THE APPREHENSION AND CONCERNS AND I THINK THAT THOSE CONCERNS ARE ALSO REFLECTED THEREFORE IN THE PROPOSED RESPONSE BY SACHRP. LET ME STOP THERE AND SEE IF THERE'S ANY COMMENTS OR QUESTIONS ON THE FIRST ONE. >>ANY COMMENTS ON THE FIRST POINT? JULIA, WOULD YOU GO DOWN, PLEASE. THE SECOND QUESTION WAS ONE THAT ANN MEEKER O'CONNELL REFERRED TO IN HER PRESENTATION PRECEDING THIS REQUESTING COMMENTS ON WHETHER A SINGLE IRB WOULD BE ABLE TO SUPPLEMENT THE MEMBER'S KNOWLEDGE WITH ADDITIONAL INFORMATION AND ASKING FOR EXAMPLES OF REGULAR RESEARCH -- >>SORRY, LET ME INTERRUPT YOU BECAUSE I SEE SKIP HAS RAISED HIS HAND. I DON'T KNOW IF IT'S ON THIS POINT OR THE PREVIOUS POINT. >>WELL, IT'S JUST A QUESTION FOR MARK. HAVING READ THROUGH THE DOCUMENT THE POINT YOU JUST MADE, I DO NOT SEE IN THE CONCLUSION AND I DIDN'T KNOW IF THE CONCLUSION WAS MEANT TO SUMMARIZE ALL THE RECOMMENDATIONS TO THE DOCUMENT BUT I -- I DON'T SEE THAT ONE RECOMMENDATION IN THE CONCLUSION. SO JUST A FORMATTING NOTE IF THAT WAS THE INTENT TO SUMMARIZE EVERYTHING. >>THE POINT OF THE CONCLUSION WAS NOT TO SUMMARIZE EVERYTHING IN THE DOCUMENT, NO. >>EXCELLENT. JUST POINTING THAT OUT. ? THE SECOND QUESTION IS WHETHER THE SECOND IRB RECORD WOULD BE ABLE TO SUPPLEMENT KNOWLEDGE WITH INFORMATION AND THE ANSWER TO THAT IS A DEFINITE, YES. IN FACT I THINK IT'S SAFE TO SAY WHETHER IT'S A SINGLE IRB OR A SINGLE IRB IT'S QUITE COMMON AND A USEFUL PRACTICE TO BE ABLE TO CALL IN EXPERTS IN ORDER TO SUPPLEMENT THE KNOWLEDGE OF A SINGLE IRB WITH ISSUES REGARDING LOCAL CONTEXT. IN SOME CASES THE SINGLE IRB RELIES ON A LOCAL INSTITUTIONAL RPP OR INSTITUTIONAL IRB TO GIVE IT TO TRANSMIT CERTAIN INFORMATION ABOUT PARTICULAR LOCAL CIRCUMSTANCES AND THE SINGLE IRB CAN TAKE THAT INTO ACCOUNT. WE ALSO TALK ABOUT IN LINE 74 TO 89 IN SOME CASES IT IS EASIER AND MORE EFFICIENT ACTUALLY TO HAVE A SPECIALIZED IRB THAN TOSS SUPPLEMENT THE KNOWLEDGE OF A SINGLE IRB WITH EXPERT OPINION AND THERE'S AN EXAMPLE OF A SINGLE IRB PERHAPS NOT HAVING ADEQUATE EXPERTISE IN PREGNANT WOMEN AND IN MEDICINE SO IT MAY BE A SPECIALIZED IRB MAY BE MORE APPROPRIATE FOR SPECIALIZED STUDIES IN SPECIALIZED POPULATION NEEDS. I'LL STOP THERE BUT THE BOTTOM LINE ANSWER SACHRP WOULD GIVE IS YES, IT WOULD BE USEFUL TO SUPPLEMENT SINGLE IRB EXPERTISE WITH LOCAL KNOWLEDGE THROUGH EXPERTS AND PROBABLY THROUGH THE USE OF A SPECIALIZED IRB. >>ANOTHER QUICK QUESTION FOR MARK. SO IN SOME SENSE TOO THE ANSWER TO TWO IS FURTHER CLARIFICATION AROUND THE FIRST RECOMMENDATION THAT THERE BE AN EXCEPTION OF A SINGLE IRB AND SPECIFIC POPULATIONS NOT SO MUCH THE SUPPLEMENT ISSUE BUT THE SPECIALIZED IRB ISSUE. >>I THINK THAT'S RIGHT. YEP. >>THE PROBLEM WE HAD IN ANSWERING THE QUESTIONS IS THAT MANY OF THE QUESTIONS FROM FDA OVERLAP AND SO AT ONE TIME IED TRIED TO DO A DRAFT THAT WE SET FORTH SACHRP'S POSITION ON THE IRB. BUT THAT WAS DIFFICULT TO DO AND STILL ANSWER QUESTIONS. UNFORTUNATELY THE WAY THE QUESTION ASKED ARE REPETITIVE OR OVERLAP PREVIOUS ANSWERS. YOU DON'T SEE A CONCRETE SACHRP TEXT. >>THERE'S AN EXCEPTION FOR COOPERATIVE RESEARCH WITH A SMALL NUMBER OF INVESTIGATIONAL SITES AND SACHRP RECOMMENDED RESEARCH INVOLVING FIVE OR FEWER SITES SHOULD BE CONSIDERED AS APPROPRIATE FOR AN EXCEPTION TO THE SINGLE IRB REQUIREMENT. IN FACT, YES, SACHRP IS REFLECTING BACK TO FDA BUT REFLECTED ON SACHRP'S PREVIOUS POSITION BECAUSE SACHRP ACCORDING TO THIS HAS BELIEVED AND STATED PREVIOUSLY AND STATED AGAIN THAT FIVE OR FEWER SITES WOULD BE AN APPROPRIATE STANDARD FOR AN ALLOWABLE EXCEPTION TO A SINGLE IRB REQUIREMENT. THERE'S NOTHING SCIENTIFIC ABOUT THIS. ONE CAN PICK A STANDARD OF FOUR OR EIGHT SITES. ONE COULD PICK A STANDARD OF 12 SITES IF ONE WANTED TO BUT THE MOST IMPORTANT THING IS THAT SOME NUMBER THAT WOULD BE REASONABLE BASED ON PRUDENCE AND PREVIOUS EXPERIENCE WE THOUGHT AND SACHRP WOULD BE FIVE OR FEWER SITES AND THE MOST IMPORTANT THING IS TO HAVE A STANDARD SO THAT THE COMMUNITY COULD UNDERSTAND AND MAKE PREDICTABLE THE APPLICATION OF THE EXCEPTION. WE DO FIGURE -- WE REINFORCED THE IDEA THAT FIVE OR FEWER WOULD BE AN APPROPRIATE REASONABLE STANDARD. >>SANDRA HAS RAISED HER HAND. FIRST, I JUST WANT TO APPLAUD ALL THE WORK THAT'S GONE INTO THIS DOCUMENT. IT'S REALLY REMARKABLE. I DID WANT TO PUSH A LITTLE BIT ON THE THRESHOLD OF FIVE. IT'S HARD TO PICK A NUMBER AND I UNDERSTAND THAT THERE NEEDS TO BE A STANDARD. IN TERMS OF THE -- TO SPEAK TO SOME OF THE DIMENSIONS YOU DESCRIBED EARLIER IN TERMS OF THE NEED FOR CONTEXTUAL OR LOCAL INFORMATION THAT MIGHT BE MORE VALUABLE, IS THERE ANOTHER WAY TO OR MAYBE TO SCAFFOLD THIS NUMBER WITH SOME -- ASSESSMENT DIMENSIONS ON HOW YOU DECIDE WHEN THERE MIGHT BE AN EXCEPTION? I GUESS THAT'S MY QUESTION. WOULD IT BE VALUABLE INSTEAD OF JUST PICKING A NUMBER? IT SEEMS RATHER ARBITRARY AND A KNOW WE'RE ACKNOWLEDGING THAT BUT IS THERE ANY MORE HELP WE CAN OFFER? >>THE ONLY THING WE COULD DO IS ONE HAS TO PICK A NUMBER, AS YOU SAID AND SACHRP SAID BEFORE. THE QUESTION IS QUALITATIVELY WHEN TO APPLY THE EXCEPTION, THAT'S THE QUESTION, THINK. WHEN WOULD ONE THINK USING THE EXCEPTION IS APPROPRIATE AND THAT'S THE DIMENSION YOU'RE ASKING ABOUT. I THINK THAT IS I THINK WE HAVE DONE THAT THOUGH WE DON'T DO IT EXPRESSLY IN THIS PARTICULAR ANSWER BUT I THINK THAT THE ISSUE IS WHETHER THERE ARE -- THE ISSUE WOULD BE IN APPLYING THE EXCEPTION AND REMEMBER THE EXCEPTION IS NOT REQUIRED. IT'S NOT A REQUIRED EXCEPTION, IT'S AN OPTIONAL EXCEPTION AND ONE THAT COULD BE OPTED INTO BY THE INSTITUTION AND INSTITUTIONS AND SITES AND INVESTIGATOR AND FUNDER. THE REASON ONE WOULD DO IT IS BECAUSE ONE THINKS THERE'S LOCAL CONDITIONS THAT WOULD MEAN IT WOULD BE APPROPRIATE TO HAVE SINGLE IRB REVIEW NOT TO HAVE SINGLE IRB REVIEW AND A SITUATION IN HAVING A REVIEW WOULD BE FOR A SMALL NUMBER OF SITES WOULD BE LESS OFFICIAL THAN SIMPLY ALLOWING SINGLE IRB'S TO DO THEIR WORK AND ALLOWING THE INSTITUTIONAL IRB'S TO DO THEIR WORK. THOSE ARE THE TWO QUALITATIVE CONSIDERAT CONSIDERA CONSIDERATIONS. >>AND THERE'S ROOM HERE AND MAY BE FIVE THAT TRIGGERS THE RATIONALE IT COULD BE LOWER. >>OF COURSE. IF THERE'S FIVE OR FEWER SITES IT COULD BE AN OPTION NOT TO HAVE A SINGLE IRB. >>THIS IS AN OPTIONAL EXCEPTION NOT ARE REQUIRED EXCEPTION. >>AND THE OTHER IS A MULTI-SITE STUDY WITH A SMALL NUMBER OF SITES AND WE REITERATE THE RESPONSES IN THE DRAFT DOCUMENT AND TALK ABOUT THE USE OF SINGLE IRB MAY BE LESS APPROPRIATE OR LESS BENEFICIAL FOR STUDIES WITH FEWER SITES ESPECIALLY IF THE STUDY IS LIKELY TO IMPLICATE SENSITIVE ISSUES IN ONE OR MORE OF THE LOCAL COMMUNITIES. AND MAY BE MORE EFFICIENT TO RESULT IN COMPLEX ETHICAL ISSUES WITH THEIR RESPECTIVE IRBs COORDINATING FOR A SINGLE IRB MAY JUST ADD AN ADDITIONAL LAYER OF COMPLEXITY. IT GETS TO THE QUALITATIVE ISSUE YOU WERE ASKING, WHEN WOULD ONE APPLY THIS FOR WHAT REASONS AND OFFER THE EXCEPTION. WE ASKED FOR THE RELATIONSHIP OF SITES AND SINGLE IRB REVIEW. WE DON'T HAVE THE DATA. THOSE ARE OUR EMPIRICAL DATA I PERSONALLY THINK WOULD BE DIFFICULT TO IDENTIFY IN A COMPREHENSIVE AND RELIABLE WAY BUT SACHRP DOESN'T DO THAT KIND OF EMPIRICAL RESEARCH AS YOU KNOW. IT'S LARGELY REPETITIVE OF WHAT WE SAID BEFORE. EVEN IF THE EXCEPTION APPLIES AND WE'RE LOOKING AT THE EXCEPTION FROM THE SINGLE IRB MAY HAVE STAKEHOLDERS AND MINIMIZE EFFECTS SUCH AS WHETHER ADDITIONAL EXCEPTIONS FROM THE PROPOSED SINGLE IRB REQUIREMENT SHOULD BE INCLUDED OR WHETHER GUIDANCE MAY -- WHAT WE ARE SAYING AND THIS IS REPETITIVE BECAUSE THE QUESTION IS SOMEWHAT REPETITIVE. WE SUPPORT THE GOAL OF A SINGLE IRB REVIEW FOR MULTI-SITE RESEARCH AND IMPROVING EFFICIENCY ON PROTECTING HUMAN SUBJECTS AND WHAT WE STATE IS SACHRP CONTINUES TO RECOMMEND AS BEFORE BOTH FDA AND OHRP CONSIDER THE FOLLOWING CATEGORIES, THREE CATEGORIES AS POTENTIALLY APPROPRIATE TO AN EXCEPTION TO SINGLE IRB REVIEW. ONE, RESEARCH INVOLVING FIVE OR FEWER SITES, TWO, RESEARCH REVIEWED BY A SINGLE IRB UNABLE TO MEET THE NEEDS OF SPECIFIC POPULATIONS AND THREE, RESEARCH INVOLVING POLITICAL CONTROVERSY OVER SENSITIVE ISSUES SUCH REVIEW BY LOCAL IRB WOULD BETTER THE CONCERNS. THIS IS A QUOTATION FROM PREVIOUS SACHRP POSITIONS ON THIS ISSUE. >>THAT'S FROM RELATIVELY RECENT SACHRP REVIEW. IT'S CONTEMPORARY. >>LAST YEAR -- THIS IS QUOTING AN ITERATION OF 12 MONTHS AGO OR SO. >>SKIP. >>I THINK THIS WOULD BE FINE. I ASSUME PROCEDURALLY OHRP WOULD THEN HAVE TO GO TO AN NRPM TO DO THIS. IT WOULD ADD THE ADDITIONAL LAYER OF COMPLEXITY TO HARMONIZE. YOU HAVE TO START SOMEWHERE. >>OKAY. AND THE NEXT ONE IS -- ANN, I WOULD WELCOME IF YOU WANT TO SAY ABOUT THIS AND FDA WAS ASKING ABOUT WHETHER FDA SHOULD ADOPT AN EXCEPTION ANALOGOUS TO THE COMMON RULES EXCEPTION IN 45CFR, 4614B2 II AND THAT IS BASICALLY AN EXCEPTION THAT SAYS IF A FEDERAL AGENCY IS FUNDING RESEARCH AND THE FEDERAL AGENCY DECIDES THERE SHOULD REALLY NOT BE SINGLE IRB REVIEW THEN OHRP WOULD DEFER AND THE COMMON RULE WOULD DEFER TO THE JUDGMENT OF THE AGENCY. THE FDA DOESN'T ROUTINE FUND RESEARCH IT'S LIKE APPLES AND ORANGES BUT WE BASICALLY SAID THE BOTTOM LINE OF THE RESPONSE IF THERE IS A FEDERALLY-FUNDED STUDY REGULATED BY FDA, THEN, YES, FDA SHOULD DEFER TO THE FUNDING AGENCY'S DECISION THERE SHOULD NOT BE A SINGLE IRB SO YES, THAT WOULD BE APPROPRIATE. AND HAVING A SITUATION WHICH FDA ITSELF HAS TO APPROVE THE USE OF A SINGLE IRB ON A CASE-BY-CASE BASIS WOULD BE ADMINISTRATIVELY COMPLEX AND WOULD PROBABLY NOT BE -- IT WOULD CERTAIN DELAY RESEARCH AND ADD AN ADDITIONAL BURDEN ON FDA AND WE WOULD NOT ENDORSE THAT. THAT'S THE BOTTOM LINE ANSWER. ANN, DID YOU WANT TO ADD ANYTHING >>WE'RE LOOKING AT RESEARCH AND PROPOSED SET OF REGULATIONS AND GET FEEDBACK FROM STAKEHOLDERS AND THE EXCEPTIONS WE'RE PROPOSING WOULD COVER MOST THE CASE WHERE THERE IS AN EXCEPTION GRANTED UNDER THE COMMON RULE BUT WE WERE JUST TRYING TO UNDERSTAND WHETHER THERE WERE ANY UNIQUE CHALLENGES THAT NEEDED AND WHETHER IT WOULD BE THERE WERE OTHER CONSIDERATIOS DOES THAT HELP? >>IT DOES. >>SKIP. >>I KNOW THERE'S A LIMITED SET OF RESEARCH PROTOCOLS THAT GO THROUGH THE FDA IRB THAT MIGHT BE CONDUCTED BY FDA. WHAT ARE YOUR THOUGHTS ABOUT THAT LIMITED SET OF RESEARCH PROJECTS? THEY CALL WITHIN THE BANNER OF FDA RULES AND REGULATIONS. WITH WERE LOOKING MORE BROADLY AT IF YOU LOOK AT CLINICALTRIALS.gov 90% OF WHAT WE REGULATE HAVE NO FEDERAL FUNDING OR SUPPORT AND WERE LOOKING AT THE REMAINING 10% AND HAVE A SINGLE SITE AND AREN'T COOPERATIVE RESEARCH AND WEREN'T FOCUSSING ON SOLELY ON RESEARCH FDA MIGHT SUPPORT. >>AND SEVEN IS REPETITIVE AND SOME WAS ANSWERED IN THE PREVIOUS DRAFT COMMENT ON SIX. AND THE EXCEPTION THAT PROVIDES FOR FDA TO DETERMINE DOCUMENT A SINGLE IRB REVIEW IS NOT APPROPRIATE AND IN ADDITION TO THE EXCEPTIONS, FDA IS HELPING ADDRESS THOSE SITUATIONS. WE SAY HERE, WE PREVIOUSLY ANSWERED THIS BY SAYING WE DO NOT THINK FDA SHOULD HAVE TO ITSELF ADJUDICATE THE USE OF SINGLE IRB. AND WOULDN'T ADD A MATERIAL BENEFIT. WE DO SAY THAT WE RECOMMEND INCORPORATING AN EXCEPTION THAT WOULD PREVENT THE COGNIZANT IRB OR INSTITUTION ENGAGED IN THE RESEARCH PRESUMABLY IN CONSULTATION TO DETERMINE ON THE CASE BY CASE BASIS A SINGLE IRB WOULD NOT BE IN THE BEST INTEREST OF THE RESEARCH SUGGESTS OR SINGLE IRB REVIEWED WOULD HELP THE SAFETY OF SUBJECTS. SO WHAT WE'RE SAYING IN RESPONSE IS NO, THE FDA NUDE NOT HAVE TO DETERMINE AND DOCUMENT A SINGLE IRB REVIEW IS NOT APPROPRIATE BUT INSTEAD THE EXCEPTION SHOULD BE SELF-EXECUTING IN THE WAYS WE DESCRIBED. >>LASTLY, FDA'S REQUESTING COMMENT ON THE PROPOSED EXCEPTIONS AND ANY OTHER CRITERIA THAT SHOULD BE CONSIDERED WHEN ASSESSING WHETHER A SINGLE IRB MAY BE WARRANTED AND LOOKING AT CLINICAL INVESTIGATIONS THAT SHOULD QUALIFY. WE ARE FDA HAS PROPOSED THE FOLLOWING EXCEPTIONS, COOPERATIVE RESEARCH, THIS IS LINE 2 OF 3, FOR WHICH MORE THAN A SINGLE IRB IS REQUIRED BY LAW AND INVOLVING A MEDICAL PRODUCT FOR WHICH UNIQUE LOCALIZED EXPERTISE IS REQUIRED AND COOPERATIVE RESEARCH THAT MEET EXCEPTIONS FROM I.N.D. AND DEVICES THAT MEET THE NON-SIGNIFICANT RISK OR REQUIREMENT FOR I.D.E. EXCEPTION. THESE ARE WHAT FDA PROTOED AS THE EXCEPTIONS. THIS EXCITED DISCUSSION IF THE SUBCOMMITTEES. THEY'RE NOT INDUSTRY SPONSORED AND NOT MEANT TO PRODUCE DATA TO BE SUBMITTED FOR FDA APPLICATIONS. BUT INSTEAD ARE REALLY MORE LOCALIZED TRIALS. WE THINK THAT THOSE POLICY GOALS WOULD ACTUALLY BE PRETTY MUCH IN VERY LARGE PART ACCOMMODATED ALREADY BY HAVING AN EXCEPTION FOR FIVE OR FEWER SITES AS AN OPTIONAL EXCEPTION. WE THINK THERE ARE ON THE OTHER HAND SOME STUDIES THAT WOULD BE I.D.E. EXEMPT THAT MAY BE INDUSTRY-SPONSORED AND SHOULD BE REQUIRED TO BE UNDER A SINGLE IRB MANDATE. THAT'S WHAT THEY'RE PROPOSING SACHRP WOULD ANSWER IN THE CASE AND BOTTOM LINE WE THINK THE FIVE OR FEWER SITE EXCEPTION IF ADOPTED WOULD ACCOMMODATE THE POLICY GOAL THAT FDA HAS ARTICULATED IN PROPOSING THESE ADDITIONAL EXCEPTIONS. WE'VE RESPONDED WITH A COUPLE EXAMPLES PREVIOUSLY AND ASKED FOR SCENARIOS THAT SHOULD BE EXEMPT FROM SINGLE IRB. WE GAVE SOME EXAMPLES HERE THAT WERE SIMPLY THINGS THAT EMERGED FROM THE COURSE OF THE CONVERSATION WITHIN THE SUBCOMMITTEES. AND THEN WE DID ADD A FINAL POINT ABOUT PROCEDURAL CONSIDERATIONS AND THAT IS WHAT'S NOT DESCRIBED IN THE FDA GUIDANCE FOR THE NRPM OR THE COMMENTARY ON IT BUT WE THINK IT OUGHT TO BE PROPOSED OR DESCRIBED AT SOME POINT AND THERE'S QUESTIONS HOW THE EXCEPTIONS WOULD ACTUALLY GET ACCESS, WHEN WOULD THEY BE TRIGGERED AND WHAT WE BASICALLY SAY HERE IS THAT THAT IT'S THE LOCAL IRB AND INVESTIGATOR AND INSTITUTIONS THAT WOULD BE ENGAGED IN THE RESEARCH THAT WOULD HAVE TO BE THE ONES TO DETERMINE THROUGH DISCUSSION AMONGST THEMSELVES WHETHER THE EXCEPTION WOULD BE APPROPRIATE OR NOT. THAT WOULD PROBABLY BE A USEFUL THING FOR FDA TO POINT OUT IN THE ULTIMATE GUIDANCE OR IN THE COMMENTARY ON THE ADOPTION OF A FINAL RULE. THAT'S BASICALLY IT. >>MARK, THERE'S A SMALL TYPO APPROPRIATE AT THE END OF THE FIRST PARAGRAPH IS MISSPELLED. >>GOT IT. >>ALL RIGHT. SACHRP MEMBERS, COMMENTS ON THIS? IS IT GOOD? DO YOU WANT CHANGES? >>I THINK IT'S WELL DONE AND DON'T HAVE PARTICULAR CONCERNS BUT THERE'S MEMBERS I'D BE CURIOUS TO HEAR FROM OTHERS. >>I'M SEEING THIS FOR THE FIRST TIME IN THE LAST COUPLE DAYS. I THINK THE RESPONSES FROM THE SUBCOMMITTEE ARE CLOR AND I APPRECIATED THE EXAMPLES THAT WERE PROVIDED WHICH REALLY MAKES IT MUCH MORE ACCESSIBLE AND REVIEWERS AND NICELY DONE. >>I'M FINE WITH THE RECOMMENDATIONS. NO COMMENTS. >>NO CONCERNS FROM ME. >>IF THERE'S A MOTION TO APPROVE THIS RESPONSE WE WILL VOTE. >>I'LL MOVE APPROVAL WITH THE CORRECTION OF THE TYPO. >>SECOND? >>SECOND. >>ANY FURTHER DISCUSSION? THEN LET'S JUST DO A SHOW OF HANDS EITHER VIRTUAL HAND OR REAL HAND OF MEMBERS. ALL IN FAVOR HANDS DOWN. ANYONE OPPOSED? ANY ABSTENTIONS? THE MOTION PASSES. THANK YOU ALL. >>THANK YOU, MARK. >>OKAY. WE CAN THEN MOVE ON TO THE OTHER PROPOSED RULE RELATED TO HUMAN SUBJECTS AND INSTITUTIONAL REVIEW BOARDS AND PROTECTIONS OF HUMAN SUBJECTS. DAVID FORSTER. >>I HAVE A COLD IN MY CHEST SO IF I SUDDENLY GO MUTE I'M HAVING COUGHING ATTACK. >>CAN YOU SEE A SLIDE PRESENTATION. FOR THOSE FOLLOWING THE PROPOSED RULE IS FOUND IN THE FEDERAL REGISTER. 87 FR587 33. >>I'LL HIGHLIGHT A POWER POINT FIRST THE THREE MAIN AREAS. I'D LIKE TO START BY SAYING AS JERRY MENTIONED, SACHRP HAS A LONG STANDING POSITION THAT MORE HARMONIZATION IS BETTER. THIS WAS A DRIVING FORCE WE'RE TRYING TO HELP THE COMMUNITY BY HAVING THE LEAST AMOUNT OF DIFFERENCES BETWEEN THE TWO SETS OF REGULATIONS, IF POSSIBLE. IT MAKES IT EASIER FOR IRB ADMINISTRATORS AND SPONSORS, ETCETERA TO DO THEIR JOBS. OVER ALL THEY CAPTURED MOST THE HARMONIZATION WE WERE HOPING FOR SO THERE'S FEW ISSUES I WANTED TO COMMENT ON TODAY. THE FIRST-ISSUE IS THE NEW ELEMENT OF INFORMED CONSENT THAT WE HEARD ABOUT EARLIER AND HERE'S THE CHOICE WE HAVE, FDA PROPOSED NEW LANGUAGE INSTEAD OF WHAT THE HHS REGULATIONS CAME OUT WITH IN 2018. OUR CHOICE IS TO RECOMMEND FDA DOES ADOPT A NEW AND DIFFERENT CONSENT ELEMENT OR DO NOT DO NOT ADOPT AND GO BACK TO ADOPT THE HHS LANGUAGE BEFORE 2018. THAT'S THAT CHOICE. IT COULD BE DISTRIBUTED FOR FUTURE RESEARCH AND THAT'S WIN ISSUE WE'LL TALK ABOUT TODAY. THE SECOND ISSUE IS ACTIVITIES PREPARATORY TO RESEARCH AND HERE FDA PROPOSE THEY DO NOT ADOPT THE 2018 LANGUAGE THAT WAS PUT INTO THE COMMON RULE. AND WE HAVE A CHOICE OF RECOMMENDING WHETHER OR NOT THEY DO ADOPT THE HHS LANGUAGE OR NOT. ABOUT ACTIVITIES PRIOR TO CONSENT. THE ISSUE IS THAT BEFORE THE 2018 REVISIONS TO THE HHS REGULATIONS IT WAS UNCLEAR WHETHER AN IRB SHOULD DO A WAIVER OF CONSENT FOR ALL THOSE ACTIVITIES THAT OCCUR PRIOR TO THE CONSENT PROCESS WHERE RESEARCHERS ARE LOOKING AT IDENTIFIABLE DATA. FOR INSTANCE, YOU'RE THROUGH CHARTS AND TALKING TO SUBJECTS AND SAYING BY THE WAY I HAVE A RESEARCH STUDY, WOULD I LIKE TO KNOW MORE ABOUT IT. IT WAS A GRAY AREA ON THE HHS SIDE WHETHER THE IRB CAN DO A WAIVER OF CONSENT AND THERE WERE ISSUES WITH HIPAA AT FIRST BUT THERE WAS RESOLUTION OF THAT AND IT CLEARED THE ISSUE UP SAYING BEFORE CONSENT YOU DON'T HAVE TO WORRY ABOUT IT OR DO A WAIVER OF CONSENT. THE ACTIVITIES CAN TAKE PLACE AND FDA HAS HAD SIMILAR GUIDANCE FOR MANY YEARS UNDER THE DEFINITION OF THE CLINICAL INVESTIGATION IT'S IRRELEVANT. IT'S IMPORTANT WE HARMONIZE IT AND THE SECOND ISSUE IS WHETHER FDA SHOULD ADOPT A WAIVER OF DOCUMENTATION OF CONSENT CRITERIA THAT HAS BEEN IN THE COMMON RULE SINCE 1991 WHERE YOU CAN WAIVE THE REQUIREMENT FOR DOCUMENTATION OF CONSENT IF THE ONLY LINK BETWEEN THE RESEARCH AND THE SUBJECT'S IDENTITY IS THE SIGNED CONSENT FORM. FDA DID NOT ADOPT THAT BACK IN 1981 AND NOW ASKING IF THEY SHOULD AND THEY'RE RARE BUT YOU CAN COME UP WITH SCENARIOS WHERE THEY MAKE SENSE. FDA HAS OTHER PROVISION FOR WAIVER OF DOCUMENTATION OF CONSENT SO IT'S NOT A NEW ISSUE AND BRING UP UNIQUE REGULATORY ISSUES AND WE THINK EVERY ONCE IN A WHILE IT WOULD BE A USEFUL PROTECTION FOR RESEARCH SUBJECT TO HAVE THIS IN FDA REGULATIONS. SO THAT IS THE SLIDE PRESENTATION. I'LL STOP SHARING THAT. THAT WAS TO FRAME IT UP. NOW I WANT TO GO TO -- RECOMMENDATIONS. CAN YOU ALL SEE THE SACHRP COMMENTARY? >>YES. I'LL START THROUGH. WE STARTED OUT BY SAYING WHAT I SAID AT THE BEGINNING, WE HAVE A SUBCOMMITTEE ON HARMONIZATION THAT CAN PROVIDE FRAMEWORK FOR ARE REVIEWING THE CHANGES PROPOSED BY FDA AND HERE WE HAVE THE ARGUMENTS OR THE ISSUE OF THE NEW ELEMENT OF INFORMED CONSENT FDA PROPOSED. -- DAVID, I KNOW YOU HAVE A COLD BUT I'M GOING TO ASK IF YOU CAN TALK LOUDER. TRY. THANK YOU. >>SORRY. YES I WAS GIVING A LIVE PRESENTATION AND I THINK EVERYONE IN THE ROOM WAS SURE I HAD COVID. REALLY UNFORTUNATE. THIS IS THE ELEMENT OF INFORMED CONSENT AND AS WE MENTIONED IN THE SLIDE DECK HERE'S THE LANGUAGE HHS REQUIRES SO PEOPLE HAVE BEEN DOING THIS AND IRBs HAVING BEEN DOING THIS AND FDA PROPOSED INSTEAD WE HAVE THIS LANGUAGE HERE. AND HOW IT MAY BE USED FOR FUTURE RESEARCH OR DISTRIBUTED AND AT THE SUBCOMMITTEE LEVEL NOT UNANIMOUS BUT CLOSE WE THOUGHT THERE WERE PROBLEMS WITH FDA'S PROPOSAL AND THE LANGUAGE IS OPEN ENDED AND SEEMS TO REQUIRE A STATEMENT ABOUT FUTURE RESEARCH BUT OFTEN TIMES AT THE TIME THE CONSENT FORM WAS DRAFTED AND IMPLEMENTED THE FUTURE RESEARCH IS NOT YET CONTEMPLATED. IT COMES UP WITH LATER LIKE HEY, WE HAVE GREAT SAMPLES THAT CAN ANSWER THAT QUESTION AND GO THROUGH THE DATA SET AND TRY TO ANSWER THE NEW QUESTION. THERE'S A CONCERN THAT THIS WILL STIFLE RESEARCH BY MAKING IT -- GIVING THE IMPRESSION THAT FDA WILL NOT ALLOW SECONDARY RESEARCH IF IT WAS NOT DESCRIBED IN THE ORIGINAL CONSENT FORM. SOME GOING WAY BACK MAY REMEMBER THE UNSPECIFIED FUTURE RESEARCH DEBATE UNDER HIPAA WHEN IT WAS FIRST RELEASED AND THE SIMILAR ISSUE CAME UP AND IN THE END THEY BACKED OFF THEIR EARLIER STATED REQUIREMENT YOU COULDN'T DO RESEARCH THAT WASN'T DESCRIBED IN CONSENT FORM. THIS HAS THE POTENTIAL TO BE THAT KIND OF DEBATE AGAIN AND THE TWO CONCERNS GOING FURTHER BEYOND THE FACT THAT IT MIGHT NOT BE CONTEMPLATED AT THE TIME THE RESEARCH IS BEING PRESENTED TO THE RESEARCH SUBJECTS. SECONDARILY THERE'S A CONCERN BY US THAT BY THE SUBCOMMITTEE THAT PEOPLE MIGHT SEE IT AS A PROHIBITION ON CONDUCTING SUCH RESEARCH SO IF YOU DID NOT DESCRIBE IT IN THE ORIGINAL CONSENT FORM IT'S PROHIBITIVE TO DO IT AND HAS TO BE PRACTICALLY DESCRIBED IN THE FIRST CONSENT FORM OR IT'S NOT ALLOWED AND MORE OF A CONCERN PERHAPS SOMEBODY DOES DO SECONDARY RESEARCH THAT WAS NOT DESCRIBED IN THE ORIGINAL CONSENT FORM, FDA COMES AND DOES AN INSPECTION AND SAY YOU VIOLATED THE CONSENT AND THOSE WERE BASICALLY A SUMMARY OF THE CONCERNS AND THE RATIONALE FOR WHY IT WOULD BE PREFERABLE IF FDA STICKS WITH THE CURRENT LANGUAGE IN THE HHS REGULATIONS AND TWO CHOICES AND LIMITED TO RESEARCH WHERE THE IDENTIFIERS IS REMOVED AND NOT RESEARCH THAT HAS IDENTIFIERS AND IS HARMONIZATION. >>I'D LIKE TO TALK ABOUT THE CONCERN AND SET UP A QUESTION ABOUT THE VERY FLEXIBILITY THAT FDA CLAIMS. I THINK ALL THE POINTS ARE ACCURATE. WHEN THIS FIRST STARTED I WAS -- IF YOU SHOWED THE LANGUAGE THE HHS LANGUAGE, AS I READ THAT, IF YOU INCLUDE STATEMENT 2 BASICALLY ALL FUTURE RESEARCH IS OUT WILL MEANS NOTHING'S GOING TO HAPPEN. THAT'S FAIRLY STRAIGHTFORWARD. THE FIRST STATEMENT IS A MIGHT. YOU MIGHT REMOVE IT AND AFTER SUCH REMOVAL YOU MIGHT USE IT WITHOUT ADDITIONAL INFORMED CONSENT. THERE'S A NUMBER OF PEOPLE THAT REASSURED ME, BOTH COLLEAGUES WITH INDUSTRY AS WELL AS IRB EXPERIENCE THAT THAT STATEMENT ONE IS STILL COMPATIBLE WITH THE CONSENT DOCUMENT OUTLINING SOME RESEARCH STUDY, IF YOU KNOW WHAT THAT'S GOING TO BE OR THE POSSIBILITY YOU MIGHT USE -- INDUSTRY WILL -- I'M THINKING INDUSTRY RESEARCH YOU HAVE IDENTIFIERS. THERE MAY BE A CODE OR SOMETHING BUT YOU CAN POTENTIALLY LINK IT. THAT IN FACT THERE WOULD BE THE POSSIBILITY IF YOU KNOW WHO IT IS TO GET ADDITIONAL CONSENT, WHICH IS WHAT YOU OUGHT TO DO AND IF YOU DON'T YOU CAN THEN REMOVE IT. I WAS REASSURED AND I HONESTLY CAN'T COME UP IN MY MIND OF A SITUATION WHERE I THINK IT WOULD BE INCOMPATIBLE WITH THAT STATEMENT. I WAS REASSURED THERE WOULD BE FLEXIBILITY FOR THE KINDS OF RESEARCH THAT PEOPLE WANT TO DO. SO THIS LEADS ME TO A QUESTION, I'D BE CURIOUS ANN MENTIONED IN HER PRESENTATION THAT THE FDA WANTED TO PICK THIS LANGUAGE BECAUSE THEY WANT TO KEEP IT OPEN-ENDED AND ONE WOULD PRECLUDE SOMETHING WORTH DOING AND MY QUESTION IS IS THERE ANYTHING CONCRETE PEOPLE COULD COME UP WITH FROM PRECLUDING STATEMENT ONE WHERE IT'S DESCRIBED IN THE CONSENT DOCUMENT YOU KNOW WHAT YOU'RE GOING TO DO OR IF YOU KNOW YOU'LL DO SOMETHING IN THE FUTURE AND HAVE IDENTIFIERS YOU CAN SEEK CONSENT BECAUSE YOU CAN ALWAYS BE IDENTIFIED AND DO WHAT YOU WANT UNDER ONE. I'M CURIOUS. ARE THERE CONCRETE EXAMPLES THAT COULD BE PROBLEMATIC IF ONE AND TWO WERE ADOPTED BY FDA. THAT'S MY QUESTION. >>IS THAT ONE OR FOR OTHERS? [NO AUDIO] SORRY, I MUTED MYSELF WHILE I WAS TALKING. PRECLUDE FUTURE POSSIBILITIES. AND WONDER IF THERE'S CONCRETE FUTURE POSSIBILITIES THAT ARE REAL OPPOSED TO JUST A GENERAL CONCERN THAT FLEXIBILITY MAY BE PRECLUDED FOR SOME POSSIBLE OPTION THAT WE CAN'T IMAGINE TODAY. IF ANN IS WILLING TO TALK TO THAT FLEXIBILITY AND THAT'S WHY THEY WERE PROPOSING WHAT GOES TO THE FLEXIBILITY OR ANYTHING ELSE. >> I CAN SPEAK TO THAT WITH A GENERAL SENTIMENT. I ALSO -- THE SECOND POINT I MADE WAS ALSO JUST GIVING CONSIDERATION TO PROVIDING INFORMATION FOR POTENTIAL PARTICIPANTS SO THEY COULD IDENTIFY POTENTIAL TYPES. AGAIN, RECOGNIZING WE WON'T KNOW WHAT THE SPECIFIC RESEARCH STUDY IS BUT IT MAY BE IMPORTANT FOR A POTENTIAL PARTICIPANT, FOR EXAMPLE, THERE'S EXAMPLES OR DATA MAY BE USED FOR EXAMPLE FOR GENETIC RESEARCH. SO BUT TO YOUR FIRST QUESTION THERE WEREN'T SPECIFIC EXAMPLES UNDER CONSIDERATION JUST A GENERAL REFLECTION OF THE WAY THAT DATA AND BIO SPECIMENS ARE USED CONTINUE TO EVOLVE. >>SANDRA. >>THAT EXPLANATION IS VERY HELPFUL BECAUSE MY QUESTION WAS WHAT IS THE PROBLEM THAT'S TRYING TO BE SOLVED HERE WITH THIS NEW LANGUAGE AND IT SEEMS TO ME FROM THE PERSPECTIVE OF PARTICIPANTS, ENABLING THEM TO UNDERSTAND THE POTENTIAL FOR FUTURE RESEARCH THIS MAY BE HELP IN STOKING THEIR INFORMATION AND I GUESS IN TERMS OF BOXING IN THE RESEARCH IT SEEMS THE LANGUAGE THAT MAY BE USED FOR FUTURE RESEARCH AND POSSIBLY GIVING EXAMPLES WOULDN'T NECESSARILY PRECLUDE OTHER PATHS BUT MIGHT ENABLE OR AUGMENT THE ABILITY FOR PARTICIPANTS TO MAKE INFORMED DECISIONS WHETHER TO PARTICIPATE OR GIVE UP BIO SPECIMENS FOR RESEARCH. I GUESS I'M TRYING TO UNDERSTAND WHETHER OR NOT THIS ACTUALLY IS RESTRICTIVE OR WHAT THE TRADE-OFF IS IN ALLOWING PARTICIPANTS TO MAKE BETTER DECISIONS. >>THE WAY WE LOOKED AT IT IS THE STATEMENTS COULD BE COMPATIBLE AND IF THEY WON'T BE USED YOU CAN USE THE SECOND STATEMENT FROM THE COMMON RULE IF THEY ARE USED IT WOULD BE A STATEMENT THAT THEY COULD BE USED OR MIGHT BE USED FOR THE KINDS OF RESEARCH THAT MIGHT BE DONE. I THINK IN THAT WAY WE SAW THEY COULD POTENTIALLY BE COMPATIBLE INSTEADOF CONFLICTING. >>I'D LOVE TO HEAR FROM THE SUBCOMMITTEE. THERE'S PROBABLY DISCUSSION ABOUT THAT BECAUSE THAT MAKES SENSE TO ME. BECAUSE IT WOULD ALLOW FOR PARTICIPANTS TO UNDERSTAND WHAT MIGHT DEVELOP IN THE FUTURE. SO WITHOUT NECESSARILY RESTRICTING THEIR USE, THE SAMPLES FROM THE DATA. >>SHOULD WE MOVE TO MARY ELLEN. >>I APPRECIATE EVERYBODY'S THOUGHTFUL COMMENTS. I SUPPORT FDA'S PROPOSED LANGUAGE FOR THE USE OF PATIENT'S DATA AND BIO SPECIMENS. AT A HIGH LEVEL WHILE THE LANGUAGE DOESN'T MIRROR THE HHS LANGUAGE BUT I THINK IT DOES HARMONIZE AND RULE THAT OUT AS AN OPPOSITION TO FDA LANGUAGE. I JUST FIND HHS LANGUAGE RIGID AND PRESCRIPTIVE. AND THE LANGUAGE IS PREFERRED AND LOOKING AT HOW TO -- THE INFORMED CONSENT SHOULD GIVE THE SUBJECT ADEQUATE INFORMATION WHETHER THEY WANT TO PARTICIPATE IN THE RESEARCH IN THE CLINICAL TRIAL FOR CLINICAL INVESTIGATION. AND I JUST DON'T THINK IT'S ADEQUATE IN THAT REGARD. I THINK IT SHOULD BE IT SHOULD BE A REGULATORY REQUIREMENT TO REQUIRE THE SPONSOR -- INVESTIGATOR TO AT A HIGH LEVEL DESCRIBE WHAT IS THE FUTURE RESEARCH AND I THINK FDA HAS FLEXIBILITY INVOLVING THE RESEARCH LANDSCAPE AND ALSO THE FACT THAT HHS LANGUAGE DOESN'T EVEN ADDRESS THE SITUATION WHERE IDENTIFIABLE SUBJECT INFORMATION OR BIO SPECIMENS MAY BE USED. I KNOW THERE WERE CONCERNS ON WHAT KIND OF LANGUAGE WOULD BE USED TO LOOK AT THE FDA'S PROPOSED LANGUAGE BUT SAYING NOTHING IS NOT -- I THINK IS AN INJUSTICE TO THE STUDY PARTICIPANT. >>IF THERE'S NOTHING DESCRIBED IN THE CONSENT FORM ABOUT FUTURE RESEARCH AND LATER THERE'S A GREAT NEW QUESTION USING THE DATA SAMPLES. WOULD YOU ALLOW IT OR NOT? ONE QUESTION, IS IT IDENTIFIABLE INFORMATION OR BIO SPECIMENS AND IT HAS TO BE IN THE INFORMED CONSENT. IF THE IDENTIFIERS ARE STRIPPED, THAT WOULD BE THE QUESTION. AND WHAT IS IN THE INFORMED CONSENT. >>IF IT WERE DE-IDENTIFIED YOU'D BE COMFORTABLE AS SAID UNDER THE HHS STATEMENT. >>THERE ARE THE REGULATIONS. OBVIOUSLY, DIFFERENT INSTITUTIONS HAVE THEIR OWN POLICIES AND POSITIONS BUT THAT'S OUTSIDE OUR SCOPE. >>I'M WONDERING HOW THE SUBCOMMITTEE CONSIDERED THE POSSIBILITY THAT INDIVIDUALS MIGHT BE WILLING TO CONCEPT TO USE OF CERTAIN BUT NOT ALL BIO SPECIMENS, FOR EXAMPLE, THEY MAY NOT BE WILLING TO TO SHARE INFORMATION THAT IS RELATED TO GENETIC RESEARCH AND MIGHT BE WILLING TO SHARE BIO SPECIMENS IN THE AREA OF INFECTIOUS DISEASE WHERE THE PATHOGEN WAS NOT -- WAS THE TOPIC OF INTEREST AND NOT SOMETHING RELATED PARTICULARLY RELATED TO THE HOST. >>ARE YOU ASKING IF THE SUBCOMMITTEE CONSIDER THAT ISSUE? >>YES. >>WE DID NOT. A LARGE PERCENTAGE OF THE SUBCOMMITTEE MEMBERS ARE OLD IRB MEMBERS AND WE REMEMBER THE DAYS OF TIERED CONSENT AND WE'LL COLLECT TISSUE SAMPLES AND YOU CAN AGREE TO THIS AND NOT THAT AND SOMEBODY WOULD HAVE TO KEEP THE CONSENT FORMS AND BE ABLE TO FIGURE OUT WHAT THE SUBJECT'S ORIGINALLY AGREED TO. AND IT TURNED OUT TO BE VERY ADMINISTRATIVE. >>THIS COULD EASILY GET UNWIELDY. >>THERE'S A FEAR ABSENT A VERY CONCRETE OR AS MARILYN SAID PRESCRIPTIVE STATEMENTS IN THE COMMON RULE WE WOULD DEVOLVE BACK TO THAT SORT OF UNIVERSE OF CHAOS. AND I DON'T KNOW IF THIS IS SATISFACTORY. TO SAY A DESCRIPTION OF HOW IT MAY BE USED FOR FUTURE RESEARCH, BLAH, BLAH, BLAH, WHAT IS MISSING FROM THERE IS CLEARLY PROMPTING SOMETHING WHAT'S SPECIFIC ABOUT ONE AND TWO IS IT'S EXPLICIT ABOUT IDENTIFYING WHETHER THEY'RE ON OR OFF. AND IF THEY'RE ON, YOU HAVE TO GET FUTURE CONSENT AND IF THEY'RE OFF THEN MAYBE YOU SHOULD USE IT, ETCETERA. ONE COULD AS A MIDDLE GROUND SAY THE FDA LANGUAGE NEEDS TO BE EXPLICIT AND THE DESCRIPTION HAS TO INCLUDE HOW IDENTIFIERS WILL BE HANDLED. HOW IDENTIFIABLE PRIVATE INFORMATION BE HANDLED, REMOVED FROM THE SPECIMEN, ETCETERA. THE BIO BANK DISCUSSION, IF YOU WILL,. AND HELP PROPOSE LANGUAGE THAT IS JUST NOT VERY HELPFUL. GOING BACK TO THE DAYS YOU REMOVED IT AND BY SAYING A DESCRIPTION OF HOW INFORMATION OF BIO SPECIMENS MAY BE USED, BLAH, BLAH, BLAH, INCLUDING A DESCRIPTION OF HOW IDENTIFIABLE INFORMATION WILL BE EITHER MAINTAINED OR REMOVED. SOMETHING LIKE THAT. COULD BE A RECOMMENDATION TO SAY THAT NEEDS TO BE AN EXPLICIT PART OF THAT CONVERSATION. JUST A THOUGHT. AND THERE'S CERTAIN SUBCOMMITTEE DISCUSSIONS SO I APOLOGIZE FOR THAT. >>WHAT IF THE RECOMMENDATION WERE TO ADOPT EXACTLY THE SAME HHS LANGUAGE OF THE TWO STATEMENTS AND THEN ADD AND/OR A DESCRIPTION OF HOW INFORMATION OR BIO SPECIMENS AND ADD IN THE FDA LANGUAGE? AND ACTUAL LY AND SAY, HEY, SPONSOR INVESTIGATORS CAN ACTUALLY USE THE HHS -- USE ONE OF THE HHS STATEMENTS. AND PROPOSED REGULATORY REQUIREMENT. AND COMBINED WITH AN AND/OR. I THINK THAT WOULD WORK. >>THEY DID SAY THE TWO STATEMENTS WOULD BE SUFFICIENT. JER JERRY. >>MAYBE IF I EXPLAIN WHAT IT'S INTENDED TO DO. IT WAS A PRETTY MODEST PROVISION IT'S NOT TALKING ABOUT IDENTIFIABLE STUFF AND RESEARCH THAT MIGHT BE DONE IF THERE'S IDENTI IDENTIFDENTIFIERS AND THERE'S A COMPLICATED SET OF PROVISIONS THAT GO TO IDENTIFIABLE BIO SPECIMENS BECAUSE THAT MEANS YOU'RE NOT USING A HUMAN SUBJECT AND RULES APPLY. THAT WAS NOT ON ANYBODY'S RADAR SCREEN. IT WAS DEALING WITH WELL DEMARCATED ISSUE THAT AGAIN ANYONE FAMILIAR WITH THESE REGULATIONS IS AWARE BY STRIPPING IDENTIFIERS YOU'RE NOW NO LONGER UNDER THE COMMON RULE AND DO WHATEVER YOU WANT WITHOUT BEING SUBJECT TO ANY OVERSIGHT. MOST WHO ARE NOT EXPERTS ON THE COMMON RULE ARE NOT FAMILIAR WITH A NUMBER OF US DRAFTED WHAT WE THOUGHT WERE HIGH VISIBILITY ITEMS AND THOUGHT IT WOULD BE A SURPRISE TO CERTAIN SUBJECTS TO SUDDENLY LEARN -- IT'S AN INTEREST PEOPLE MY HAVE IN NOT PROVIDING BIO SPECIMENSES -- BIO SPECIMENS IN A RESEARCH STUDY UNLESS THEY KNOW THEY CAN CONTROL THE DOWN STREAM USE AND SOMETHING SOME WOULD HAVE NO CLUE ABOUT AND THE RULES ALLOW YOU TO STRIP IDENTIFIERS AND TWO WHATEVER THEY WANT WITH IT AND THAT WAS WHAT IT WAS INTENDED TO DO AND THE TWO STATEMENTS WERE TO LET PEOPLE KNOW THAT WAS A POSSIBILITY, THAT'S ALL IT WAS INTENDED TO SAY OR MAKE A PROMISE TO THEM, NO, THEY WON'T DO THAT AND THERE SHOULD BE RULES RELATING TO CONTENT, ETCETERA. THIS PROVISION WAS NOT INTENDED TO DEAL WITH THAT AND THERE ARE OTHER PROVISIONS, ETCETERA. AND IN CASE THAT MAY BE HELPFUL I WANT PEOPLE TO UNDERSTAND WHAT PART OF THE UNIVERSE OF TO THE STATEMENT WAS AND NOT DESIGNED TO CURE AND HAPPY TO ANSWER ANY QUESTIONS. >>I'M FINE IF THE COMMITTEE STICKS WITH THIS AND I WOULD ADD THE PHRASE CONFIDENTIALITY AND HOW THE IDENTIFIERS WERE HANDLED WOULD BE ADDRESSED RATHER THAN JUST A DESCRIPTION. I DO THINK LOGICALLY WITH STATEMENT 1 THAT WOULD BE INCLUDED IN THE CONCEPT DOCUMENT AND STILL HAVE OTHER DESCRIPTIONS HOW IT WOULD BE USED TO BE COMPATIBLE WITH FUTURE OPTIONS. I'D BE WILLING TO SUPPORT EITHER WHAT'S THERE NOW OR THE MINOR CHANGE OF MAKING THE FDA AS A THE IDENTIFIABLE SPECIMENS NEED TO BE ADDRESSED AS PART OF THAT. JUST TO LAY THAT OUT. >>THANK YOU. OTHERS? >>A QUICK COMMENT. JERRY, THANKS FOR PROVIDING THAT CONTEXT. THAT WAS REALLY GOOD. MY ONLY RESPONSE TO THAT IS THAT UNDER THE NOTICE OF PROPOSED RULE MAKING, FDA'S PROPOSED RULE MAKING THERE'S THE NATION NOT AT THE TIME TO INCLUDE -- A NOTION NOT AT THE TIME TO INCLUDE THAT. >>I DON'T KNOW WHETHER TO VOTE OR IF CONSUELO OR OTHERS WHO HAVEN'T SPOKEN WOULD LIKE TO SPEAK ON IT. ARE COMMITTEE MEMBERS READY TO APPROVE THE DOCUMENT? >>I'M THINKING TO MOVE FORWARD MAKES SENSE TO MAYBE NOT A VOTE ON THE DOCUMENT BUT ON THE ISSUE. MARY ELLEN AND I WERE BOTH INVOLVED IN SUBCOMMITTEE DISCUSSIONS AS REVISIT IING. THE OTHERS DIDN'T HEAR THAT AND FINDING OUT WHAT PEOPLE WANT TO DO ON THIS ONE I THINK WOULD BE USEFUL. >>SKIP, WOULD YOU MIND RESTATING WHAT THE PROPOSAL IS? >>I THINK THERE'S TWO POSSIBLE DISTRIBUTIONS WE CAN DO. I'M PERSONALLY CONVINCED THAT THE KIND OF FLEXIBILITY THAT FDA IS CONCERNED ABOUT ON THE USE OF BIO SPECIMENS IN THE FUTURE IS COMPATIBLE WITH THE INCLUSION STATEMENT, NUMBER ONE AS JERRY OUTLINED THAT WAS MEANT TO ALERT PEOPLE THERE'S A POSSIBILITY IT COULD BE USED IN WAYS THEY DON'T ANTICIPATE FOR IDENTIFIESE EEER IDENTIFIERS AND WHAT WE MIGHT DO WITH BIO SPECIMENS I THINK ARE COMPATIBLE WITH NUMBER ONE. FROM THAT STANDPOINT, DO I THINK IT'S A PROBLEM WITH SACHRP'S CURRENT RECOMMENDATIONS? NO. THE OTHER OPTION MARY ELLEN OFFERED IS TO MAKE IT A THREE WITH A FOUR AND THEN HAVE THE FDA'S LANGUAGE BUT I WOULD THEN PROPOSE WE ADDRESS HOW IDENTIFIABLE PARTICIPATION WOULD BE HANDLED. THAT WOULD REQUIRE A CHANGE. I PERSONALLY KNOW WE NEED TO GET THIS DONE TODAY AND TOMORROW AND THE COMMITTEE SAID WE'RE FINE WITH THIS. AND TO THINK IF THERE'S PROPOSAL WITH THE'S LANGUAGE MAKES MORE SENSE I COULD GO EITHER WAY BUT IT WOULD BE HELPFUL FOR ALL OF YOU WHO ARE NOW HEARING THIS FOR TODAY TO SAY WHAT YOU THINK. AND THREE IS WE STATE WHAT THREE IS? >>AND/OR A DESCRIPTION OF HOW THE ONE CHANGE WOULD BE HOW IDENTIFIABLE INFORMATION OR BIO SPECIMENS MAY BE USED FOR FUTURE RESEARCH OR DISTRIBUTED TO ANOTHER INVESTIGATOR FOR FUTURE RESEARCH. >>IF I UNDERSTAND CORRECTLY BASED ON WHAT JERRY SAID IT'S NOT NECESSARY. I THINK THAT'S WHAT JERRY WAS SAYING. >> >>I AGREE. I RAISED THE ISSUE THAT ONE IS NOT PRECLUDED FROM THOSE RESEARCH AND WHY I SAY PERSONALLY I WOULD GO WITH THE CURRENT RECOMMENDATION BUT IF OTHERS WANTED TO ADD I COULD ADD THAT TOO. >>WHERE IS IT ADDRESSED IN TERMS OF A DESCRIPTION OF THE POTENTIAL FUTURE USES? ELSEWHERE IN THE CONSENT DOCUMENT OR IF YOU KEPT IDENTIFIABLE SPECIMENS YOU'LL HAVE TO GET ADDITIONAL INFORMED CONSENT AS JERRY POINTED OUT IT'S COVERED BY OTHER ASPECTS OF THE REGULATIONS. >>THEY PUT OUT GUIDANCE SAYING THEY DO ALLOW IT. >>YEAH. SO WITH ALL OF THIS DISCUSSION SUPPORTING ONE OR TWO SHOULDN'T BE A PROBLEM. THAT'S WHERE I CAME UP HAVING RAISED ALL THE ISSUES HAVE BEEN RAISED. >>THERE'S A FEW WE HAVEN'T HEARD FROM. IT'D BE NICE TO HEAR FROM YOU WHETHER YOU'RE COMFORTABLE WITH THE LANGUAGE OR IF IT NEEDS CHANGE AND IF IT NEEDS A CHANGE WE'LL NEED TO BE SPECIFIC. >>I'M COMFORTABLE WITH IT. >>I THINK IT'S CLEAR AND SUFFICIENT. >>SANDRA? CONSUELO? >>I'M THINKING. >>I THINK A CHANGE WOULD REQUIRE MORE DISCUSSION AND SPECIFICITY AND MY CONCERNS NOT THAT THE THE LEVEL WHERE I FEEL IT'S NECESSARY AND I'M OKAY WITH THIS GIVEN THE TWO STATEMENTS. >>I'M GOING TO ASSUME SILENCE IS COMFORT WITH THE CURRENT LANGUAGE. I GUESS YOU CAN TAKE US THROUGH THE REST OF THE DOCUMENT. WHAT I'M HEARING NOW IS TO KEEP IT AS IS. >>SOUNDS GOOD. THE NEXT SECTION IS THE ACTIVITIES PERPTORY TO RESEARCH AND MAY NOT GET AS INVOLVED. THIS GOES BACK TO ONE OF THE FIRST ACTIVITIES ON HARMONIZATION PREP ARATORY TO RESEARCH AND THE ACTIVITIES INVESTIGATORS ENGAGE IN PRIOR TO THE CONSENT PROCESS DON'T NEED CONSENT. THEY -- THE IRB CAN APPROVE THE RESEARCH WITH THE ACTIVITIES DESCRIBED AND IN PLACE AND DIDN'T NEED TO WORRY ABOUT CONSENT FOR THE CHART OR SUBJECTS OR LOOKING AT DIAGNOSTIC TESTS THAT HAVE BEEN TAKEN. HIPAA CAME OUT AND CAME OUT WITH THE ACTUAL TERM PREPARATORY RESEARCH AN GAVE ALLOWANCES TO THOSE ACTIVITIES AND OHRP AT THE TIME I BELIEVE SAID IF YOU'RE LOOKING AT IDENTIFIABLE PRIVATE INFORMATION THEN YOU EITHER NEED CONSENT OR A WAIVER OF CONSENT AND THEIR RECOMMEND WAS EVERY IRB DO A WAIVER OF CONSENT WITH EVERY PROTOCOL THAT HAD ACTIVITIES LOOKING FOR RESEARCH SUBJECTS AND AND YOU HAVE TO GO LOOK AROUND TO SEE IF YOU HAVE SUBJEC SUBJECTS OHRP IGNORED THE GUIDANCE AND IT GOT RESOLVED WHEN THE COMMON RULE WAS PUT OUT WHEN AN IRB IS LOOKING AT THE SITES OF PROPOSALS WHERE AN INVESTIGATOR WILL OBTAIN INFORMATION WITHOUT INFORMED CONSENT THEY'LL OBTAIN INFORMATION FOR THE PROSPECTIVE SUBJECT IN THE FUTURE AND ASK FOR CONSENT OR OBTAIN INFORMATION BY IDENTIFYING BIO SPECIMENS. IT AND THE SACHRP RECOMMENDATION WAS ADOPTED BY THE COMMITTEE. FDA SAID THIS DOESN'T APPLY TO US WE DON'T HAVE A DEFINITION THAT INCLUDES THAT WE HAVE CLINICAL INVESTIGATION INSTEAD AND THAT'S NOT AN ISSUE AND WE HAVE THIS GAP. SO THERE'S NO PROBLEM. AND IT WILL BE EASIER IF FDA INVOLVE THE REGULATORY LANGUAGE AND FOR NEW PEOPLE COMING INTO IRBs AND INVESTIGATOR AND COORDINATOR ROLES AND SPONSORS, THEY KNOW THIS. IT'S FLAT-OUT STATED IN THE REGULATION AND DON'T HAVE TO LOOK FOR FDA GUIDANCE THAT EXPLAINS THIS. THAT'S THE RECOMMENDATION. ONE OTHER THING AND THOUGH FDA LIMITS THEIR CLINICAL INVESTIGATION THERE'S A FUNNY SITUATION FDA ALSO PUT OUT IN SEPTEMBER OF THIS YEAR AND GUIDANCE DOCUMENT THAT SAYS WE'LL TAKE REAL-WORLD EVIDENCE DATA AND THAT COULD BE OBSERVATIONAL STUDIES, IT WOULD BE CHART REVIEWS, ALL SORTS OF THINGS THAT SAY ACCEPT DATA BEYOND A CLINICAL INVESTIGATION. BASED ON THAT WE THOUGHT FDA SHOULD ADOPT THE LANGUAGE AND NOT WORRY ABOUT TRYING TO RESOLVE IT. OPEN FOR CONVERSATION. >>A QUESTION. IT'S FAIRLY COMMON FOR AN INVESTIGATOR TO SORT OUT FEASIBILITY. I'M ASKING THE LINE BETWEEN FEASIBILITY AND WHEN YOU'RE ACTUALLY SCREENING, RECRUITING OR DETERMINING WHETHER A CERTAIN PATIENT IS ELIGIBLE AND THAT FEASIBILITY OFTEN MIGHT REQUIRE AN INVESTIGATOR -- A POTENTIAL INVESTIGATOR TO LOOK AT ELECTRONIC HEALTH RECORDS, COUNT UP HOW MANY PEOPLE MAY MEET CERTAIN CRITERIA, ETCETERA. NOT TO DETERMINE JOHNNY JONES IS ELIGIBLE BUT HOW MANY JOANY JONESES ARE THERE. THAT'S LONG BEFORE -- YOU HAVE A CONTRACT AND PROTOCOL OR ANYTHING THAT'S ON THE TABLE TO THE IRB. I'M CURIOUS, FROM YOUR IRB EXPERIENCE HOW WOULD YOU ASSESS THAT ACTIVITY? THEY'RE NOT RIGHTING DOWN NAMES. THEY'RE JUST COUNTING UP HOW MANY JOHNNY JONES THEY GOT. THEY'RE LOOKING AT IT BUT NOT WRITING IT DOWN. HOW DO YOU JUDGE THAT IN THE IRB? >>I THINK IT FITS IN THE LANGUAGE IN THE COMMON RULE ON THE SCREEN. >>IT SAYS AN IRB MAY APPROVE THIS IS BEFORE THE IRB. I THINK IT'S DANGEROUS TERRITORY WHETHER AN IRB SHOULD BE -- >>I'M JUST ASKING HOW YOU INTERPRET THE LANGUAGE. I DON'T THINK THE IRB SHOULD BE INVOLVED IN THE EARLY FEASIBILITY AND ONE COULD SAY THE INVESTIGATOR IS NOT OBTAINING IT BUT BUT THEY'RE LOOKING AT THE MEDICAL RECORDS TO SAY HOW MANY DO I HAVE. >>IT'S NOT A PROBLEM. >>WE WORKED ON THIS MANY YEARS AGO TOGETHER AND WE DON'T HAVE TO BELABOR THIS BUT THIS LANGUAGE SAYS IRB MAY APPROVE INVESTIGATOR IN THE FUTURE DOING SOMETHING AND WHAT SKIP IS TALKING ABOUT IS BEFORE THE PROPOSAL WAS EVERY WRITTEN FOR THE IRB THE INVESTIGATOR IS GOING AROUND THE RECORDS TO UNDERSTAND WHAT THE CRITERIA SHOULD BE AND COVERED UNDER THE HIPAA PREPARATORY TO RESEARCH AND I THINK THE ANSWER IS LEADING HIPAA ASIDE WHETHER IT WILL BE COVERED UNDER PREPARATORY TO RESEARCH IT'S JUST AN ACTIVITY THAT IS NOT CLEARLY REGULATED BY THE COMMON RULE BECAUSE IT'S NOT RESEARCHED WHAT'S DONE IN THE SITUATION. I DON'T THINK THERE'S A BIG ISSUE WITH IT AND THERE'S THE PROCESS OF AN INVESTIGATOR GOING IN RECORDS. THAT'S FINE. >>NOT HEARING COMMENTS I THINK I'LL CONTINUE ON. >>IT IS COMMON PRACTICE TO TRY TO CHARACTERIZE THE FEASIBILITY OF CONDUCTING RESEARCH ACTIVITY BY TRYING TO UNDERSTAND FOR EXAMPLE HOW MANY INDIVIDUALS MAY BE ELIGIBLE FOR RESEARCH ACTIVITY WITHIN AN INSTITUTION OR INSTITUTIONS. IT MAKES A FEASIBILITY STUDY MORE FEASIBLE, IF YOU WILL. >>THE NEXT IS WAIVER OF DOCUMENTATION CONSENT. I MENTIONED THIS DURING THE SLIDE PRESENTATION. CURRENTLY AND SINCE 1981 UNDER THE HHS REGULATIONS THERE'S BEEN AN ALLOWANCE FOR A WAIVER OF DOCUMENTATION OF CONSENT. YOU DON'T HAVE THE SUBJECTS SIGN THEIR NAME. IF THE ONLY LINK BETWEEN THE RESEARCH AND SUBJECT IS THE SIGNATURE ON THE CONSENT FORM AND THAT THERE'S STIGMATIZING AGENCY SPENT WHERE THERE COULD BE CRIMINAL LIABILITY ETCETERA, AND I APPRECIATE THE FACT THEY BROUGHT THIS UP SAYING THIS IS SOMETHING WE HAVEN'T DONE IN THE PAST AND SHOULD WE DO IT NOW? WE THOUGHT OF A FEW EXAMPLES. THERE'S MONKEY POX OR SOMETHING WITH ABORTION, PREGNANCY TESTING IN THE FUTURE AND MAYBE A SIMILAR TYPE OF ISSUE. WE THINK THOUGH IT WILL NOT BE COMMONLY USED AND NOT COMMONLY USED WITH HHS REGULATIONS, AT TIMES IT IS A GOOD WAY TO PROTECT RESEARCH SUBJECTS FROM POSSIBLE LIABILITY AND GOING TO STIGMATIZATION OR LEGAL THREATS OR FINANCIAL HARM, ETCETERA. IT'S A PROVISION IN THE COMMON RULE. IT IS WHEN IT IS APPLICABLE, IT IS A GOOD PROVISION. I THINK BETTER THAN THE CERTIFICATE OF CONFIDENTIALITY BECAUSE YOU DON'T HAVE THE RECORD TO PROTECT IN THE FIRST PLACE. OUR RECOMMENDATION IN THE SUBCOMMITTEE WAS THIS SHOULD INVOLVED THE FDA AS WELL AND THERE'S ANOTHER WAIVER OF DOCUMENTATION OF CONSENT PROVISION IN THE CURRENT FDA REGULATIONS WHEN THERE'S MINIMAL RISK AND NORMALLY WOULD NOT OBTAIN CONSENT IN THE CLINICAL SETTING AND NOT NEW TO FDA. >>WE TALKED ABOUT THE DOCUMENTATION AND I KNOW THAT THE FDA WOULD HAVE GUIDANCE FOR TRACKING INFORMED CONSENT AND AUDITING THE RECORDS YET DELINKING, IF YOU WILL, FROM THE SUBJECT AND THERE'D HAVE TO BE THOUGHT ABOUT THE PROCESS. >>THERE IS ALSO PROVISION FOR WAIVER OF DOCUMENTATION. THAT ISSUE HAS BEEN THERE SINCE THE FDA REGULATIONS WERE ADOPTED. >>BUT THAT'S FOR IN VITRO DIAGNOSTICS RIGHT? >>NO, JUST IN THE -- >>I WASN'T ON THE INSPECTION SIDE OF THE HOUSE SO MAY THEY HAVE ALREADY FIGURED THAT OUT AND I'LL ALSO POINT OUT THERE'S BEEN A LOT OF RESEARCH DONE ON THE TOPICS WITHOUT SUCH A WAIVER OF DOCUMENTATION AND WHETHER IT WAS DONE -- DO I HAVE A PROBLEM WITH ADOPTING THIS WAIVER? NO. I ASSUME FDA WOULD SORT OUT IF THERE'S ANY PROCEDURAL ISSUES THEY HAVE TO ADDRESS AND YOU'RE SUGGESTING THEY HAVE ALREADY DONE THAT. >>THERE'S SOME THINGS THAT DON'T WARRANT DISCUSSION AT THIS LEVEL AND THE 90 DAYS FOR IMPLEMENTATION AND AGAIN -- SOME VERY MORE ADMINISTRATIVE --0 DA IMPLEMENTATION AND AGAIN -- SOME VERY MORE ADMINISTRATIVE --10 D IMPLEMENTATION AND AGAIN -- SOME VERY MORE ADMINISTR80 DAYS FOR IMPLEMENTATION AND AGAIN -- SOME VERY MORE ADMINISTRATIVE -- AND THE FLEXIBILITY MARK WAS NOT OUR EXPERTISE SO WE DIDN'T COMMENT ON THOSE SECTIONS. THEN WE GET TO SACHRP RECOMMENDATION ON BIO SPECIMENS. THIS IS ABOVE AND BEYOND WHAT IS IN THE NRPM AND WHAT WE'RE ASKING HERE IS THAT THE FDA CLARIFY HOW IN VITRO DIAGNOSTIC RESEARCH USING LEFT OVER DE-IDENTIFIED SAMPLES SHOULD BE HANDLE TO HARMONIZE THE REGULATION AMONG HHS. THE ISSUE IS THE FDA DEFINITION OF A SUBJECT AND DEVICE REGULATIONS INCLUDES INDIVIDUALS ON WHOM OR ON WHO'S SPECIMEN AND INVESTIGATIONAL DEVICE IS USED OR HAS A CONTROL. SO FDA'S INTERPRET THIS TO INCLUDE STUDIES INVOLVING PERFECTIVE COLLECTION OF SPECIMENS AND DE-IDENTIFIED SPECIMENS AND THE COMMON RULE LANGUAGE LOOKS AT DE-IDENTIFIED SPECIMENS NOT CONSIDERED TO BE RESEARCH BY THE SUBJECT. I THINK TO SOME EXTENT THIS HAS BEEN ADDRESSED BY FDA GUIDANCE. SO IT'S REALLY MORE OF A PROACTIVE RECOMMENDATION BY SACHRP TO THINK ABOUT THIS ISSUE. I WOULD WELCOME COMMENTS IN THIS AREA. >>I THINK THE RISK IS THAT THE COMPLIANCE RISK IS THAT INVESTIGATORS ARE ACCUSTOMED TO THINKING DEIDENTIFIED SPECIMEN NOT HUMAN SUBJECTS AND THEREFORE DOES NOT NEED A WAIVER OF CONSENT, WHEREAS IF AN INVESTIGATOR IS GOING TO AN INDUSTRY-SPONSORED AGREEMENT OR AN INVESTIGATOR WITH AN WANTS TO USE DE-IDENTIFIED LEFT OVER SPECIMENS TO SUPPORT AN APPLICATION OR SUBMIT TO THE FDA UNDER FDA REGULATIONS WOULD REQUIRE AN IRB PROTOCOL AND WAIVER OF INFORMED CONSENT . THAT'S THE DISSONANT WE SEE HERE. >>AND ADOPTED. IT'S BECOME MUCH LESS OF AN ISSUE THAN IT USED TO BE. I'M GOING TO TAKE AS SILENCE AS GOLDEN. DAVID BORASKI. I KNOW YOU WERE ADDED TO THE AGENDA TOMORROW AND ASSUME YOU WERE ADDED TO ADDRESS THIS AREA WHERE FDA SAID THESE HERE'S THE THINGS WE'RE NOT ADDRESSING AT THIS TIME. DO YOU WANT TO COMMENT ON THIS SECTION? >>HAPPY TO ROLL THROUGH THIS. THIS SECTION WAS ADDED LATE IN THE PROCESS OF PREPPING THE COMMENTS BUT HOPEFULLY WE GET A CHANCE TO LOOK THROUGH THEM AS THEY LOOK THROUGH THE MATERIALS IN GENERAL BUT REALLY HASN'T BEEN FOR THE SUBCOMMITTEE THE SAME DEGREE OF COVERAGE AS THE OTHER ASPECTS. SO IN THIS SECTION, IT REALLY OHRP ASKS SACHRP TO COMMENT ON THE COMPONENTS OF THE NRPM THAT DO NOT -- I SHOULD SAY, ASPECTS OF THE REVISED COMMON RULE NOT REFLECTED IN TERMS OF HARMONIZATION IN THE NRPM AND BEGINNING THE PARAGRAPH STARTING AT LINE 270 IS THE LANGUAGE FROM THE FDA'S NRPM AND LIST THE NUMBER OF THINGS NOT INCORPORATED IN THEIR NRPM AND I THINK OF NOTE SOME OF THAT IS BECAUSE THERE ARE A FEW THINGS THAT ARE ALREADY ADDRESSED IN OTHER ONGOING DRAFT GUIDANCES OR OTHER PROPOSED THINGS FROM THE FDA SO IF YOU CAN SCROLL AT LINE 280, SACHRP WAS ASKED TO TALK ABOUT A FEW SPECIFIC THINGS INCLUDED AND THESE INCLUDE THE CONSENT FORMS ON A PUBLICLY AVAILABLE GOVERNMENT WEBSITE, THE BROAD CONSENT PROVISIONS, THE USE OF LIMITED IRB REVIEW, EXEMPT RESEARCH AND PUBLIC HEALTH SURVEILLANCE ACTIVITIES. THE GENERAL THEME IS THAT OUR TAKE ON THIS IS THAT THESE EXCLUSIONS ARE INTENTIONAL BECAUSE MANY OF THE THINGS THAT THEY COVER ARE LIKELY TO BE IRRELEVANT TO THE TYPE OF CLINICAL INVESTIGATIONS REGULATE WILL BY THE FDA. STARTING AT 292 WE TALKED ABOUT THE ONE THING NOT QUITE THE SAME IS THE POSTING OF INFORMED CONSENT DOCUMENT ON THE PUBLICLY AVAILABLE FEDERAL WEBSITE. YOU SEE THE CITATION THERE AND AT LINE 295 WE NOTE -- SORRY, MY ELBOW BUMPED THE MUTE BAR. THERE'S PRACTICAL CHALLENGE THOSE FDA'S ADOPTION OF THIS REQUIREMENT. AND SOME WAS NOTED IN THE RESPONSE TO THE OLD COMMON RULE NRPM THAT AND INDUSTRY SPONSORS WOULD LIKE TO POST THEIR CONSENT FORMS AND INSISTING ON THE DEGREE OF REDACTION ON THE MATERIALS TO OBSCURE PROPRIETARY INFORMATION THE DOCUMENT THAT ENDS UP BEING POSTED WOULD LIKELY PROVIDE INSIGHT TO THE MANNER ON WHICH INFORMATION IS CONVEYED TO RESEARCH SUBJECTS. THE UTILITY FOR POSTING THE DOCUMENTS IS UNSETTLED. AND THE POSTING FOR REQUIREMENT CONSENT FORMS IS NOT WELL UNDERSTAND AND THE WAY THE RULE IS WRITTEN AND POSTED CONSENT FORMS ARE NOT NECESSARILY THE FINAL CONCEPT FORM OR THE STUDY OR THE INFORMATION PROVIDED TO ALL PRCHTS. AND MAY GO TO THE PUBLIC POSTING CONCEPT FORMS IN RESPONSE TO THE COMMON RULE NRPM AND THE FOOT NOTE THERE AND THE LANGUAGE IS TAKEN FROM THE PREAMBLE OF THE COMMON RULE AND THERE'S ADMINISTRATIVE BURDEN AND RISK OF LITIGATION AND COMPLIANCE THOSE WERE RAISED IN THE COMMENTS PRECEDING THE COMMON RULE. I'LL PAUSE AND SEE IF THERE'S QUESTIONS OR COMMENTS ABOUT THE AGREEMENT THIS IS AN APPROPRIATE THING TO EXCLUDE FROM HARMONIZATION. A AND THE PRIVATE SECTOR SPONSORS WOULD SEEK TO REDACT SUFFICIENT AMOUNT OF PROPRIETY INFORMATION FROM THE CONSENT DOCUMENTS AS TO MAKE THEM UNINTELLIGIBLE. >>WITH THE NEW CLINICAL TRIALS REGULATIONS THIS YEAR AND NOT VOLUNTARILY NEXT YEAR THINGS LIKE INVESTIGATOR BROCHURES ARE POSTED PUBLICLY AND ALL THE COMPANIES ARE GOING THROUGH A PROCESS OF REDACTING THOSE. DO YOU KNOW IF THE CONSENT DOCUMENT IS PART OF THAT OR NOT? >>I DON'T KNOW, SKIP. SEARCH THINGS WILL BE REDACT FROM THIS FORM AND IN EUROPE THEY'RE GOING SO FAR AS THE INVESTIGATOR BROCHURE BE POSTED PUBLICLY AND THERE'S MORE PROPRIETY INFORMATION THAN IN A CONSENT DOCUMENT. I'M FINE WITH THIS AS A GENERAL COMMENT. >>THE NEXT QUESTION IS ABOUT BROAD CONSENT. THE PROVISIONS ARE LARGELY INAPPLICABLE TO MOST FDA REGULATIONS AND IT'S BEEN ADOPTED IN COMMON RULE REGULATED RESEARCH IS UNCLEAR BUT ANECDOTALLY UPTAKE IS UNDERSTOOD TO BE GENERALLY LOW. THE PROVISIONS ARE LARGELY IRRELEVANT IN THE FDA REGULATIONS. >>I AGREE WHOLEHEARTEDLY WITH THAT ONE. THESE ARE NOT RESEARCH ACTIVES BUT PUBLIC HEALTH PRACTICES AND OUTSIDE THE SCOPE OF NOT INVESTIGATIONAL STUDIES BUT PUBLIC HEALTH PRACTICES. >>JERRY, YOU HAVE YOUR HAND UP? >>GOING BACK TO THE POSTING OF CONSENT FORMS YOU MADE A COMMENT ABOUT THE PUBLIC RESPONSE TO THAT PROPOSAL. I'M AWARE THAT INDUSTRY DIDN'T WRITE TO THE PROPOSAL BUT MY SENSE AND THIS WAS ONE OF THE BEST RECEIVED PROPOSALS AS FAR AS ALL THE CHANGES MADE TO THE COMMON RULE. WHETHER THERE'S ON THE HHS SIDE ORFULLY FEDERAL -- FEDERALLY FUNDED SIDE ALL THE RESEARCH BEING DONE IS ULTIMATELY GOING TO BE USING PEOPLE AS RESEARCH SUBJECTS AND SEEMS APPROPRIATE THE EXTENT THE LAWS OF THIS COUNTRY ARE BEING USED TO ALLOW ENTITIES TO PROFIT FROM DOING THAT AND THE KEY PART OF MAKING THAT RESEARCH ETHICAL SHOULD BE MADE PUBLIC. I'M CURIOUS WHEN YOU SAY YOU HUGELY DISLIKE THE PROPOSAL I'M NOT SURE WHAT I'M MISSING HERE. I'D BE VERY SURPRISED -- I WANT IT MAKE IT CLEAR FOR YOU GUYS AND ALSO FOR THE PUBLIC THAT VIEWING THIS. >>IN THE FOOT NOTE -- I'LL POINT OUT THE RECOLLECTION OF A NUMBER OF US. THERE MAY BE DISSATISFACTION OR ANOTHER WITH A PROVISION OF RELATING TO 5.7 BUT I NEED HELP. AGAIN, MY APOLOGIES FOR NOT NOTICED THIS AHEAD OF TIME AND WHAT THE CITATION IS SAYING. >>THE URL IS IN THE FOOT NOTE AND I'LL TROUBLE PULLING IT UP TO DISPLAY IT BUT THAT'S A QUOTE FROM >>COULD BE COMMENTS FROM INDUSTRY AND PEOPLE HAVING AN INTEREST IN NOT HAVING THEIR OWN CONSENT FORMS FOR LAWYERS TO LOOK AT, ETCETERA, BUT IN TERMS OF THE GENERAL PUBLIC REACTION TO THAT PROVISION IT WAS THE TAKE OF A NUMBER OF US IT WAS VERY WELL RECEIVED. AND ENCOURAGE THE PUBLIC IN GENERAL AND THIS WAS LIKE SOMEHOW GOT SNUCK IN THERE WOUND UP IN THE FINAL RULE CHANGE IF EVERYONE WAS SO NEGATIVE ABOUT IT. >>I HAD A QUESTION I THINK IN LINE WHERE THERE'S A MENTION THERE ISN'T UTILITY IN THE POSTING OF THE INFORMED CONSENT MATERIALS AND IF IT'S A WAY TO ENGENDER AND NURTURE PUBLIC TRUST. IS THAT THE UTILITY BEING QUESTIONED? IN LINE 300. TO THE EXTENT THERE'D MAYBE THE PUSHBACK IN TERMS OF REACTION. IS THE SPIRIT OF THE REQUIREMENT IN QUESTION OR IS IT THAT AND WANTING MORE CLARITY IN THAT STATEMENT. >>I WOULD SAY THAT STATEMENT IS SUBJECTIVE AND MAYBE MORE OPINION THAN FACTS. I'D BE HAPPY WITH STRIKING IT. >>IF THE CONSENT FORMS ARE A WAY TO CONVEY TO THE PUBLIC THERE'S TRANSPARENCY YOU WOULD SAY THE UTILITY IS QUITE HIGH EVEN TO THE THERE MAY BE EFFORTS TO LIMIT THE AMOUNT OF INFORMATION FOR VARIOUS REASONS. >>IT MAY BE FAIR TO REMOVE THE WORD UNKNOWN OR STRIKE IT TOGETHER AND I DON'T KNOW IF THE MAJORITY OF THE PUBLIC KNOW WHERE THE FORMS ARE POSTED OR SACHRP MEMBERS KNOW WHERE THEY'RE POSTED. >>I'D WANT MORE CLARIFICATION FOR TO STRIKE IT. >>I THINK WE CAN STRIKE IT. >>WE'D LIKE TO COMMENT ON THE PUBLIC HEALTH SURVEILLANCE AND I DON'T KNOW IF THERE'S MORE COMMENTS ON THE PUBLIC HEALTH ASPECT. >>AS I RECALL THE CONVERSATION HAS THE COMMON RULE BEING DEVELOPED. THE AND THE CONCERN IT WOULD HAVE HAD THE SAFETY SURVEILLANCE ACTIVITIES. IT IMPLIES THE FDA'S NOT INVOLVED AND THERE'S PUBLIC HEALTH ACTIVITY THE FDA IS INVOLVED IN THAT MAY NOT INVOLVE EDUCATIONAL USE BUT INVOLVED IN THE SURVEILLANCE >>I'D DIFFERENTIATE THIS AS PUBLIC HEALTH SURVEILLANCE. >>I AGREE. HAVING BEEN AT THE FDA DURING THAT TIME AND MAKE SURE PUBLIC HEALTH SURVEILLANCE IS CARVED OUT BUT I KNOW MOST OF US THINK OF THIS AT THE CDC AND OTHER ACTIVITIES. WOE WE NEED TO KNOW THE CHANGES MADE BY THE DOCUMENT. I'M WONDERING IF IT'S NECESSARY TO SAY THAT. CAN WE JUST REMOVE THAT CLAUDE AND PUT IT IN THE FOOT NOTE? I THINK DAVE IS CORRECT IN WHAT IT SAYS. I WOULD SAY THE FACT THE FEDERAL GOVERNMENT WENT AHEAD AND MADE THE CHANGE WAS A RECOGNITION I THINK A LOT OF THE COMMENTS WERE FROM THE USUAL SUSPECTS YOU WOULD SUSPECT WOULD NOT WANT THEIR CONSENT FORMS MADE PUBLIC SO THEY SAID A HUGE AMOUNT OF WORK ETCETERA BUT WHEN YOU LOOK AT THE BROADER INTEREST OF PUBLIC AND PROBABLY MANY MEMBERS OF THE PUBLIC WE'RE LESS AWARE OF THE BENEFITS AS YOUR COLLEAGUES NOTED DURING THE SESSION. >>AND WE'RE SPECULATING ON THE FDA'S MOTIVATION AND KNOWLEDGE OF IT AND SO I'D STRIKE IT. >>I DON'T THINK IT'S NECESSARY. >>WHAT IF THE FINAL SENTENCE? DOES IT STAND ON ITS OWN? >>I THINK IT'S TRUE. THERE'S RISK INFORMATION AND THAT KIND OF INFORMATION IT'S AN INTERESTING QUESTION WE DON'T HAVE TO GO THERE. 307 AND 308 IS A TRUE STATEMENT. >>STRIKING THE HIGHLIGHTED SENTENCE I THINK IS APPROPRIATE. >>I THINK IT WILL READ BETTER IF WE SAY COMMON CONCERNS INCLUDE SINCE IT'S NO LONGER REFERRING TO THAT PRIOR SENTENCE. THOSE ARE BASICALLY THE TWO CHANGES? I'M SEEING NO OTHER HANDS FROM COMMITTEE MEMBERS ABOUT OTHER CHANGES THEY WOULD LIKE SO I WOULD I GUESS ASK FOR A MOTION. I MOVE TO ENDORSE THE DOCUMENT SUBJECT TO THE REVISIONS WE DISCUSSED. >>DO I HAVE A SECOND? >>SECOND. >>ANY FURTHER DISCUSSION? HEARING NONE, LET'S VOTE WITH A SHARE OF HANDS REAL OR VIRTUAL. ALL IN FAVOR OF MOVING THIS RECOMMENDATION FORWARD RAISE YOUR HAND. ALL OPPOSED. >>I -- LET ME REWORD THIS I APPROVE SUBJECT TO A MODIFICATION TO THE ADDITIONAL PROVISION REGARDING FUTURE RESEARCH USE OF INFORMATION AND BIO SPECIMENS AND I DO HAVE SOME PROPOSED LANGUAGE -- >>OKAY. >>I KNOW I'M MUDDYING THE WATER. >>I'M NOT SURE HOW TO HANDLE THIS. >>ABSENT -- WE CAN LOOK AT THE LANGUAGE OUT OF COURTESY BUT ABSENT THAT IF EVERYBODY ELSE VOTES -- >>THIS IS CORRECT. >> >>I GUESS I DON'T THINK WE REALLY HAD AN OPPORTUNITY TO GO THROUGH WHAT THIS PROPOSED LANGUAGE AND HOW IT WOULD READ. >>AT THIS POINT WE HAVE FIVE IN FAVOR, ONE OPPOSED AND NO ABSTENTIONS SO THE MOTION DOES CARRY. JULIA -- >>I WOULD PROPOSE YOU COULD ENTERTAIN MARY ELLEN'S REVISION AND VOTE ON IT AT THAT POINT. IT'S A MAJORITY VOTE. IT DOESN'T NEED TO BE UNANIMOUS VOTE. >>OKAY. >>I GUESS I WOULD JUST ASK FOR THE RECORD IF MY PROPOSED LANGUAGE WOULD BE INCLUDED IN THE MINUTES. >>RIGHT. >>AND WHAT IS THAT, MARY ELLEN? IT WOULD BE EXACTLY THE SAME HHS LANGUAGE SO IT'S NOT ADDING A THIRD STATEMENT, I WANT TO CLARIFY THAT. WE WOULDN'T HAVE TO CHANGE ANYTHING. IT WOULD BE EXACTLY ONE OF THE FOLLOWING STATEMENTS AND THEN IT WOULD BE ONE AND TWO SEMI COLON AND WHEN APPLICABLE, COMMA, A DESCRIPTION OF HOW IDENTIFIABLE PRIVATE INFORMATION OR BY IDENTIFIABLE BIO SPECIMENS MAY BE USED FOR FUTURE RESEARCH ARE DISTRIBUTED TO ANOTHER INVESTIGATOR FOR FUTURE RESEARCH. >>OKAY. SO WE DID ACTUALLY DISCUSS THIS EARLIER. >>WE DISCUSSED IT BUT IT WASN'T A DISCUSSION OF A THIRD STATEMENT AND IT'S NOT REALLY A THIRD STATEMENT OTHERWISE YOU HAVE TO CHANGE THE BEGINNING OF HHS BECAUSE YOU HAVE TO INCLUDE ONE OF THE FOLLOWING. MAYBE THAT'S NUANCED. TO CAPTURE THE ESSENCE OF IT. >>WE CAN CAPTURE THAT IN THE MINUTES UNLESS OTHER MEMBERS FEEL STRONGLY WE SHOULD ENTERTAIN THIS AS AN AMENDMENT. SO I THINK THAT'S WHERE WE WILL LEAVE IT. MY SUGGESTION AT THIS POINT IS WE TAKE A BREAK, JULIA, IF THAT'S OKAY AND WE HAVE COMPLETED OUR AGENDA FOR TODAY AND WE HAVE SUFFICIENT TIME TO LAUNCH INTO TOMORROW'S AGENDA AFTER THE BREAK. SO -- >>WHAT I WOULD PROPOSE, DOUG, AT THIS POINT, IT'S 1:40. I PROPOSE PEOPLE COME BACK AT 2:15. DAVID FORSTER, I DON'T KNOW IF YOU'RE UP TO IT BUT WOULD YOU POSSIBLY BE ABLE TO DO SOCIAL MEDIA AND I CAN CONTACT -- I NEED TO REACH OUT TO STEVEN TO SEE IF HE POSSIBLY COULD FOLLOW YOU WITH A.I.? WE MAY BE ABLE TO ACCOMPLISH THE ENTIRE AGENDA. WE'LL SEE. BUT I DON'T THINK SOCIAL MEDIA WILL TAKE LONG, A.I. WILL TAKE LONGER BUT I NEED TO SEE IF I CAN GET HOLD OF STEVEN SO THAT WOULD BE MY PROPOSAL TO HAVE EVERYONE PLEASE COME BACK AT 2:15 JUST A REMINDER FOR THE SACHRP MEMBERS WE'RE AT QUORUM SO WE CAN'T DISCUSS ANYTHING WITHOUT YOU AND CERTAINLY CAN'T VOTE WITHOUT YOU. TO PLEASE DO COME BACK. WE INVITE YOU TO COME BACK PROMPTLY, PLEASE AT 2:15. >>I WOULD SAY MORE THAN INVITE, I WOULD LIKE ALL OF YOU TO COME BACK FOR SURE. >>IT'S ALMOST A DEMAND. >>WE PROMISE. >>ALL RIGHT. >>AND DAVID, THANK YOU FOR BEING WILLING TO TAKE OVER ON SOCIAL MEDIA. THAT'S VERY HELPFUL. WE ARE ADJOURNED TO 2:15. >>I HOPE WE'LL GO STRAIGHT FROM SOCIAL MEDIA TO A.I. OKAY. CAN WE CONFIRM WE HAVE ALL OF OUR MEMBERS BACK? >>I'M HERE, CONSUELO. >>THANK YOU. >>GOOD. THEN WE HAVE TWO MORE ITEMS LEFT FOR THIS MEETING AND THE NEXT ONE WE'RE GOING TACKLE IS THE IMPACT OF SOCIAL MEDIA USE ON HUMAN SUBJECT RESEARCH AND DAVID, THAT WILL TAKE US THROUGH THE FINE WORK THAT YOU'RE SUBCOMMITTEE'S DONE ON THIS TOPIC. YOU'RE MUTED, DAVID? >>IS THAT A PROBLEM? [LAUGHTER] >>OKAY. I'LL SHARE MY SCREEN. CAN YOU SEE IT? >>YES. >>AND IS IT LARGE ENOUGH? >>IT CAN BE A LITTLE LARGER. I'M SORRY. >>OKAY. >>THANK YOU. >>ABSOLUTELY. SO I MADE THE MISTAKE OF HAVING NUTS AS A SNACK DURING THE BREAK AND CAUSED A COUGHING FIT. THIS IS GOOD SHAPE AND NOT CHANGED FROM THE PARENT COMMITTEE THOUGH I REALIZE WE HAVE NEW MEMBERS AND THIS WILL BE NEW TO YOU. THIS IS A RECOMMEND ON A SET OF SPECIFIC QUESTIONS FROM OHRP TO SACHRP REGARDING THE USE OF SOCIAL MEDIA BY RESEARCH SUBJECTS AND ASKED SIX SPECIFIC QUESTIONS ON THE PROBLEMS WITH RESEARCH SUBJECTS GETTING ON TO SOCIAL MEDIA PLATFORMS TO DISCUSS CLINICAL RESEARCH AND WHAT, IF ANY, INTERVENTIONS SHOULD IRB INVESTIGATORS AND OTHERS CONSIDER REGARDING THIS OCCURRENCE OF RESEARCH SUBJECTS USING SOCIAL MEDIA. SOME WILL REMEMBER EARLY ON WE WENT WIDE RANGING OF EVERY EFFECT SOCIAL MEDIA CAN HAVE ON RESEARCH AND NARROWED BACK DOWN TO SPECIFIC QUESTIONS OHRP ASKED OF US. BURY START GOING THROUGH THIS I'LL ASK IF THERE ARE ANY PARTICULAR BROAD COMMENTS ABOUT THIS OR ANY PLACE ANYBODY WANTS TO GO DIRECTLY TO TO START THIS OFF. >>THE FIRST IS A SIMPLE INTRODUCTION. I'LL GIVE A DESCRIPTION OF SOCIAL MEDIA. AS YOU MAY REMEMBER MY CHILDREN LAUGHED WHEN I TOLD THEM I WAS WORKING ON THIS AND ASKED IF I WANTED A TIKTOK ACCOUNT AND THEN WE GET TO THE FIRST QUESTION ABOUT WHAT ARE THE PRIMARY CONCERNS WITH SUBJECT'S USE OF SOCIAL MEDIA TO DISCUSS THEIR PARTICIPATION IN ONGOING RESEARCH AND WHAT IMPACTS HUMAN RESEARCH PROTECTIONS? AND MAY REMEMBER JANET WHO IS NOT ON THE CALL TODAY HAD A BIG ROLE IN CHANGING THIS FROM JUST CONCENTRATING ON THE POSSIBLE NEGATIVE EFFECTS TO THE POSSIBLE BENEFITS OF SUBJECTS COMMUNICATING ON SOCIAL MEDIA ABOUT RESEARCH STUDIES THEY'RE PARTICIPATING IN. WE SAID THERE WERE THREE AREAS THAT NEED TO BE DISCUSSED AS FAR AS PRIMARY CONCERNS. ONE IS SUBJECT SAFETY WHICH CAN BE IMPACTED IN SEVERAL WAYS. THE OTHER THE SECOND IS SCIENTIFIC VALIDITY. THIRD, WE SAID THERE CAN BE BENEFITS AND LARGELY FROM JANET'S POSITION FROM A PATIENT AND SUBJECT ADVOCATE SHE HAD BEEN INVOLVED WITH A VARIETY OF SOCIAL MEDIA DISCUSSIONS THAT HELPED IN THE PARTICIPATES -- PARTICIPATION AND ASK IF THERE'S A RESPONSE TO QUESTION ONE? ALL RIGHT. QUESTION TWO, ARE THERE TYPES OF TRIALS WHERE THE CONCERNS MAY BE MORE OF A PROBLEM AND IF SO WHY AND ARE DIFFERENT MITIGATION MEASURES FOR DIFFERENT TRIALS? WE STATED BY SAYING THE THINGS WE'RE WORRIED ABOUT IS SUBJECT SAFETY AND SCIENTIFIC VALIDITY. WE SAID MOST THE CONCERN WITH SCIENTIFIC VALIDITY WILL HAVE TO GO WITH MULTI-ARM BLINDED STUDIES WHERE POTENTIALLY THE RESEARCH SUBJECTS OR THE RESEARCH STAFF CAN REALIZE WHICH ARM THERE ON OR A WAY TO IDENTIFY WHICH ARM VARIOUS ARMS ARE ON OR LOOK AT THE PLACEBO OR TASTE OR SIDE EFFECT OF THE DRUG AND HAVE LINE 91 AND 95 NOTING SIMILAR ISSUES CAN COME UP IN SOCIAL BEHAVIORAL RESEARCH FOR INSTANCE, IF THERE'S A PSYCHOLOGY STUDY INVOLVING DECEPTION AND ONE OF THE EARLY SUBJECTS GOT ONLINE AND SAID HERE'S WHAT THEY SAID IN THE DE BRIEFING. ANY COMMENTS ON THAT SECTION? AND THE NEXT IS WHETHER THERE'S TOOLS OR FUNDING AGENCIES OR INVESTIGATORS OR STAFF, ETCETERA, CAN USE TO ILLUMINATE AND MITIGATE THE CONCERNS ON SOCIAL MEDIA AND WHAT ARE EXAMPLES OF MITIGATION STRATEGIES. ONE IS RESEARCH FOR STUDY AND STAFF AND THERE COULD BE FUNDING AGENCIES OR OHRP OR OHRP STAFF OR NON-PROFITS AND DISCUSS THE PROS AND CONS OF USUAL SOCIAL MEDIA AND HAVE THAT PROVIDED TO SUBJECT PRIOR TO THE PARTICIPATION OF RESEARCH. YOU CAN USE IT IN THE CONCEPT PROCESS OR FORMS AND WOULD ASK OR REQUIRE SUBJECT TO REFRAIN FROM DISCUSSING CERTAIN ASPECTS OFF THE TRIAL ON SOCIAL MEDIA AND PENALTIES HAVE REMOVAL FROM THE RESEARCH AND THAT WOULD NEED A LOT OF JUSTIFICATION TO PUT THOSE LIMITATIONS ON SUBJECT'S ACTIVITIES. THE HAVE AUTONOMY ON HEALTH AND IT CAN GIVE AN IMPRESSION THERE'S SOMETHING SECRETIVE GOING ON. THERE ARE A FEW PAPERS OUT TH THERE. ANY QUESTIONS OR RESPONSES TO THREE? QUESTION FOUR, WHICH SPECIFIC REGULATORY ISSUES ARE LIKELY TO ARISE FROM CONSIDERING THE CONCERNS OR COMMON MITIGATION STRATEGIES? HEREWE TRIED TO TIE IT BACK TO THE REGULATIONS AND THIS IS A FAIRLY GENERAL SECTION. WE SAID CLEARLY THERE'S ISSUES OF THE IRB CRITERIA FOR APPROVAL AND CONSENT AND SUBJECTS HAVE THE RIGHT TO WITHDRAW FROM ANYTIME AND CAN LOOK FOR INFORMATION THAT MAY AFFECT THEIR DECISION TO PARTICIPATE IN RESEARCH. THAT SOCIAL MEDIA COULD CHANGE COMMUNICATION AND RISK BENEFIT RATIO GOING BACK TO 4611H2 AND COULD CHANGE IN POPULATION-MANNER DROP OUT OR STAY IN THE RESEARCH AND I MADE A CORRECTION THERE. FINALLY, THE PROCESS FOR MONITORING DATA DURING THE RESEARCH COULD BE AFFECTED AND FINALLY, THERE'S SIMILAR CONCERNS IN FDA REGULATIONS FOR DRUGS. ANY QUESTIONS IN RESPONSE TO QUESTION FOUR? >>IF WE CAN GO DOWN TO THE LAST PAGE WHERE WE TALKED ABOUT -- YEAH, 154 AND 155. I THINK IT'S NOT SIMPLY THE PROCESS BUT THE INTEGRITY OF SAFETY DATA COLLECTION. I SPENT MOST OF THE TIME IN THE AREA OF VACCINES AND APPRECIATE THE PERSPECTIVE THAT JANET PROVIDED WHERE SOCIAL MEDIA HAS BEEN A -- IF YOU WILL, A SOCIAL IN RAISING AWARENESS OF TRIALS AND POTENTIAL OPPORTUNITIES TO PARTICIPATE IN TRIALS. VACCINES, HAVE FOR A VARIETY OF REASONS, BECOME A SCIENTIFIC AND SOCIALLY DIVISIVE TOPIC. IT'S NOT JUST MISINFORMATION BUT DISINFORMATION DISSEMINATED AROUND VACCINES. AND DO I WORRY ABOUT THE POTENTIAL FOR VACCINE TRIALS AND VACCINE PROGRAMS TO BE MALICIOUSLY UNDERMINED THROUGH THE USE OF SOCIAL MEDIA. THAT'S A PROBLEM STATEMENT. I'M NOT AWARE OF IT HAVING HAPPENED STATE BUT IT'S A PROBLEM STATEMENT AND I THINK IT'S A POSSIBILITY. I DO WONDER HOW WE MIGHT MITIGATE THAT RISK AND WE CAN GET TO THAT IN A BIT BUT I'LL PUT THAT FORWARD AS AN ISSUE THAT'S OF SIGNIFICANT CONCERN TO ME. >>WALTER, YOU MAY REMEMBER EARLY ON WE DID HAVE THAT AS A TOPIC AND WHEN WE DECIDED TO NARROW DOWN TO THE QUESTIONS OHRP ASKED US, WE HAD DISCUSSION WHETHER PEOPLE ALREADY IN THE RESEARCH AND PARTICIPATING IN SOCIAL MEDIA WOULD BE THE ONES WHO WOULD TRY TO MALICIOUSLY GET TO THE RESEARCH AND WE TOOK IT OUT. >>AGAIN, THANKS FOR REMINDING ME. THIS PERTAINS ONLY TO THOSE WHO ARE ACTIVELY INVOLVED, RECRUITED IN RESEARCH. >>YEAH. OHRP HANDLES A PRETTY NARROW SET OF QUESTIONS TO ANSWER ABOUT SUBJECTS WHO ARE PARTICIPATING. >>I THINK -- IT'S A REMOTE POSSIBILITY -- AND BY DEFINITION, THOSE WHO ARE DEEPLY SUSPICIOUS OF VACCINES FOR ALL SORTS OF REASONS WOULD BE LESS LIKELY TO ENROLL IN VACCINE TRIALS BUT I DO WONDER A BIT WHETHER THE SAME WAY WE PROVIDE GUIDANCE TO PARTICIPANTS ON NOT NOT OFTEN NOT TAKING CERTAIN THERAPEUTICS OUTSIDE THE TRIAL AND WHETHER WE SIMILARLY PROVIDE GENERAL GUIDANCE ABOUT THE USE OF APPROPRIATE USE OF SOCIAL MEDIA BEARING IN MIND THAT I THINK IT'S A REAL ISSUE TO THE POINT YOU MADE WITH THE DOCUMENT MIX ABOUT NOT WANTING TO CREATE SOME SENSE OF BEING INTRUDED UPON ON PARTICIPATING RESEARCH. >>AND LET ME KNOW IF YOU HAVE SPECIFIC LANGUAGE YOU'D LIKE US TO CONSIDER. >>QUESTION FIVE, ARE THERE CIRCUMSTANCES WHERE IT'S APPROPRIATE ON AN AGREEMENT TO ARE REFRAIN FROM SHARING STUDY INFORMATION ON SOCIAL MEDIA, IF SO, WHAT ARE THE CIRCUMSTANCES AND WHAT SHOULD BE CONSIDERED WHEN ENCOUNTERING SUCH A PROPOSAL. WE SAID THIS SHOULD BE VERY LIMITED. IT SHOULD BE AN INSTANCE WHERE IT'S DIFFICULT TO BLIND THE STUDY. PERHAPS THE STUDY ARTICLE OR PLACEBO HAS IDENTIFIERS. WHERE SUCH PROHIBITION OR AN ACT OR PROPOSAL WOULD BE NECESSARY FOR THE RESEARCH TO BE POSSIBLE. WE THOUGHT A SIMILAR COROLLARY IS DECEPTION IN RESEARCH AND RARELY USE IT BUT EVERY ONCE IN A WHILE IT'S NECESSARY FOR STUDY DESIGN. WE DO NOTE HERE THE VIEW POINT THROUGH LINE 27 TO 175 WE DO OFTEN CONDITION RESEARCH SUBJECT'S PARTICIPATION ON NOT TAKING CERTAIN ACTIONS SUCH AS NOT BECOMING PREGNANT, TAKING PART IN CO-MEDICATIONS AND SAID HERE THE NEXUS BETWEEN THE SUBJECT SAFETY AND RESEARCH VALIDITY IS NOT AS DIRECT DISCUSSING THE STUDY ON SOCIAL MEDIA IS NOT AS DIRECT AS THE ISSUE OF BECOMING PREGNANT OR TAKING DRUGS. WE FINALLY DISCUSSED LINE 176 TO 179 YOU ALSO NEED TO DECIDE IF YOU'RE GOING TO MAKE THIS A STATEMENT YOU CAN'T PARTICIPATE IN SOCIAL MEDIA AND SAY IS THERE RECOMMENDATIONS OR PENALTIES OR REMOVED AND REMOVED FROM SUBJECTS OR IRB. >>THERE'S SOME PLACEBO CONTROLLED AND I WONDER ABOUT THE RISK OF SINCE INJECTABLE VACCINES ARE TYPICALLY ASSOCIATED WITH SOME INJECTION SITE REACTION. WHETHER WE MIGHT BE -- WHETHER THE SHARING OF INFORMATION -- SHARING PATIENT EXPERIENCES MIGHT LEAD TO AN EXAGGERATED DIFFERENTIAL BETWEEN INTERVENTION ARM AND PLACEBO ARM BY VIRTUE OF SHARING AN INDIVIDUAL HAD HEADACHE AND NAUSEA AND INJECTION SITE TENDERNESS, EVEN UNINTENTIONALLY HAVE THE AFFECT OF BIASSING OTHER RECIPIENTS TO OVER REPORT THOSE EVENTS WHICH ARE -- WHICH TEND TO BE TYPICALLY RELATED TO INJECTION OF A VACCINE WHICH INDUCES AN IMMUNE RESPONSE AND SOME LOCALIZED SITE REACTIONS. >>WE DIDN'T GET TO THE LEVEL OF THAT TYPE OF DETAIL IN THE RECOMMENDATION TO DATE. BUT IF YOU HAVE SOME PROPOSED LANGUAGE -- >>LET ME THINK ABOUT THAT. >>I HAVE A QUESTION. I THINK QUESTION SEVEN. JUST WONDERING WHAT IT MEANS A DECISION WOULD BE VERY FACT DEPENDENT. THEY WOULD END A SUBJECT'S PARTICIPATION BASED ON THE SUBJECT'S HEALTH OR HEALTH OF OTHERS AND WHETHER IT WOULD COMPROMISE THE STUDY OR RESEARCH AND THAT DECISION SHOULD BE VERY FACT DEPENDENT. WHAT DOES FACT DEPENDENT MEAN? >>WHAT I WAS TRYING TO GET ACROSS AND APPARENTLY DID NOT, IT WILL DEPEND ON THE PARTICULAR SUBJECT AND RESEARCH STUDY AND WHAT HAPPENED TO THEM, WHAT HE THE SOCIAL MEDIA COMMENTARY WAS. THERE'S A LOT OF FACTORS. IT'S DIFFICULT TO COME UP WITH A BROAD STATEMENT ABOUT WHAT MIGHT BE INVOLVED IN AN ACTUAL DECISION TO END A PARTICIPATES AND WHAT HARMS DOES THE DISCLOSURE ON SOCIAL MEDIA CAUSE. >>THE DEMONSTRATION OF ACTUAL HARM WOULD BE A JUSTIFICATION, BUT SORT OF THAT -- I'M WORRIED, FOR EXAMPLE, IF SOMEBODY WENT ON SOCIAL MEDIA AND STARTED TO SPREAD MISINFORMATION OR MAYBE IT'S ACCURATE INFORMATION ABOUT A STUDY. HOW WOULD THE RESEARCHER DEMONSTRATE HARM IN THIS CASE TO JUSTIFY -- >>I THINK THEY HAVE TO SHOW OR AT LEAST BE CONCERNED ABOUT HARM TO SUBJECTS OR HARMED TO VALIDITY OF THE STUDY. IT MAY PREVENT THE STUDY FROM GOING FORWARD. THERE'S A LOT OF FACTORS IN COMPARING THIS. IT MAKES ME THINK OF SUBJECT COMPLAINTS. IT'S HARD TO DESCRIBE THEM IN ADVANCE OR TO COME UP WITH GENERAL RULES BECAUSE THEY'RE SO DIFFERENT WHEN THEY COME IN. >>YES, I GUESS I WAS GETTING TRIPPED UP WITH THE FACT DEPENDENCY. >>DO YOU HAVE A BETTER WAY TO DESCRIBE IT? >>OH, GOSH -- >>-- DEPENDING ON THE SITUATION. FACTS OF THE PARTICULAR CIRCUMSTANCE? >>MAYBE AN ACKNOWLEDGEMENT AS YOU SAY IT WILL DEPEND ON THE SPECIFIC DETAILS OF THE CONTEXT. I'M NOT SURE. OR MAYBE YOU TAKE IT OUT. >>THAT MIGHT BE EASIER. IS THAT WHAT YOU PREFER TAKE IT OUT? >>BECAUSE IT'S SO OPEN TO INTERPRETATION AND I'M NOT SURE WHAT THRESHOLD WE'RE SUGGESTING IN TERMS OF DEMONSTRATING IN A FACTUAL WAY THERE'S BEEN HARM. I WELCOME OTHER COMMITTEE MEMBERS' THOUGHTS ON THIS AND LOOKS LIKE CONSUELO HAS HER HAND UP. >>I HAVE CONCERNS MORE BROADLY BUT CERTAINLY RELATED JUST IN GENERAL HOW WE IMAGINE THIS WOULD BE OPERATIONALIZED. DETERMINING WHO IN SOCIAL MEDIA SPACE WITH NAMES AND IDENTITIES AND HOW MUCH TIME ARE PEOPLE GOING SPEND TO DETERMINE WHAT IS FACTUAL AND WHAT THE EVIDENCE IS. THERE'LL BE A LOT OF SUBJECTIVITY. >>I AGREE. >>WE CERTAINLY HAVE HAD ISSUES AND A RESEARCH SUBJECT BEING THROWN OUT OF RESEARCH AND COMPLAINING THE IRB AND WASN'T ABLE TO PARTICIPATE. THESE CAN VARY IN HOW THEY UNFOLD FROM WHAT THE ISSUES ARE. NONE OF WHICH WE CAN SAY ANYTHING USEFUL FOR WITHOUT SPENDING A LONG TIME ON IT. I SUGGEST THE SENTENCE BE DELETED. >>OKAY. THAT'S THE BAR. NOT OR WHATEVER OR YOU DON'T LIKE WHAT THEY SAID. THAT'S WHAT I WOULD SUGGEST. >>THAT'S EASY. AND WE SKIPPED OVER QUESTION SIX. THAT'S WHETHER CIRCUMSTANCES WAS APPROPRIATE FOR AN INVESTIGATOR TO MONITOR THE SUBJECT'S USE OF SOCIAL MEDIA. WHETHER IT SHOULD BE DISCLOSED IN THE CONSENT PROCESS OR IT'S DIFFICULT TO MONITOR SOCIAL MEDIA USE BECAUSE THERE'S DOZENS OF PLATFORMS, YOU DON'T HAVE TO USE YOUR NAME, YOU CAN USE VARIOUS MONIKERS. HER POINT IS SHE'S ON VARIOUS RESEARCH OR MEDIA GROUPS -- SOCIAL MEDIA GROUPS THAT ALL OF A SUDDEN DROP OUT OF THE SKY OR DISAPPEAR AND PEOPLE CHANGE THEIR NAMES. SHE WANTED TO MAKE THE POINT THAT YOU CAN SUGGEST DOING THIS BUT EVEN IF YOU DO, IT WILL NOT BE EASY. >>GO TO 191. THIS IS THERE'S THE CHESSRA PROGRAM DEVELOPED AT THE UNIVERSITY OF WISCONSIN AT WHICH TIME PROVIDED -- BEFORE WE USED THE TERM SOCIAL MEDIA THIS GOES BACK SEVERAL YEARS AGO. AND A MODERATED FORUM FOR INDIVIDUALS WHO ARE INTERESTED IN A PARTICULAR DISEASE. I REMEMBER THERE WERE A COUPLE DIFFERENT MALIGNANCIES. FOR EXAMPLE THERE WAS A FACULTY MEMBER AT THE UNIVERSITY OF WISCONSIN WHO WAS ABLE TO ADDRESS QUESTION CAME UP AND THERE WERE ISSUES AROUND LIVING WITH CANCER AND IT WAS PRIMARILY AND THERE WAS ALWAYS A MODERATOR WITH EXPERTISE OVERSEEING THIS. AND WE MIGHT CONSIDER THAT APPROACH AND THAT'S WHAT THEY'RE GETTING AT. AND I THINK AND LET ME PAUSE ON THAT ONE. >>AS A PART OF THE INFRASTRUCTURE FOR A TRIAL -- I'M NOT -- I'M ACTUALLY THINKING IF YOU ENROLL IN A TRIAL AND YOU HAVE ACCESS TO THIS SOCIAL MEDIA PLATFORM FOR THE TRIAL AND YOU CAN SHARE YOUR EXPERIENCES. >>194 AND 195 GIVES AN ALTERNATIVE, YOU HAVE AN IDENTIFIED SOCIAL MEDIA PLATFORM. HAVE YOU AN IDENTIFIED MODERATOR. THAT'S VERY DIFFERENT THAN 183 TO 189 WHICH YOU'LL HAVE SOMEBODY TROLLING ALL THE DIFFERENT SOCIAL MEDIA PLATFORMS AND TRYING TO FIND LANGUAGE AND DISCUSSION WHICH WOULD BE CRAZY. IN THE PARAGRAPH OF 196, AS SUCH IS A BIT AMBIGUOUS. I WOULD AGREE WHERE YOU LOOK FOR TALKING ON SOCIAL MEDIA WOULD BE BURDENSOME AND IMPOSSIBLE TO DO. AND SETTING UP A DEDICATED SOCIAL MEDIA PLATFORM AND GROUP WITHIN A PLATFORM WOULD NOT BE. IF YOU PUT IT UP ITS SETS A DIFFERENT TONE AND THE ALTERNATIVE IS A POSSIBILITY. >>IS IT A NON-SECULAR -- IN OTHER WORDS, IF WE START WITH THE HOWEVER, MONITORING, IT REFERS TO THE PARAGRAPH ABOVE. WE CAN ADD A STATEMENT HERE THERE COULD ALSO BE POSSIBILITIES TO ESTABLISH -- AS A DEDICATED SOCIAL MEDIA FOR -- I WAS INTERPRETING 195, 199 NOW AND MONITOR AND AN I.T. WIZARD TROLLING MEDIA PLATFORMS. >>FOR THOSE NOT INVOLVED IN THE PRIVATE SECTOR SIDE, COMPANIES ARE EXPECTED TO MONITOR NOW AND TO LOOK AT LEAST REFERENCES TO THEIR PRODUCTS ON THOSE SOCIAL MEDIA PLATFORMS LIKE TWITTER AND IT'S BURDENSOME. THIS IS NOT ANYTHING THAT A SINGLE ACADEMIC GROUP COULD TAKE ON IT'S REALLY BURDENSOME. AND IF THERE'S A DEDICATED CHANNEL FOR A TRIAL IT BECOMES A LOT MORE REASONABLE I THINK. I INTERPRETED AS A SITE AND GIVEN THE ROLE OF MONITORING A DEDICATED OR ARE WE -- >>YEAH, THAT WORKS. MODERATING A DEDICATED -- >>DEDICATED ON LINE 195 AND THEN REALLY, I DON'T THINK YOU NEED THAT LAST SENTENCE. I THINK UNLESS IT'S A DEDICATED SITE AND UNLESS YOU PUT A LOT OF RESOURCES LIKE INDUSTRY, IF THEY SEE AN ADVERSE EVENT THERE'S REPORTS THAT'S PARTLY WHAT'S DRIVING SOME OF THE MONITORING. DEDICATED IS SUFFICIENTLY IMPLIES WE'RE IN THE TALKING ABOUT FACEBOOK BUT -- >>WALTER, IT COULD BE A FACEBOOK GROUP. WHY NOT. >>THE POINT IS NOT IT'S ALL OF FACEBOOK. IT COULD BE A DEDICATED GROUP IF YOU WANT TO MAKE IT MORE INCLUSIVE. >>YEAH, DISCUSSION. I THINK WE KNOW AND WE'RE GETTING A BIT INTO THE WEEDS HERE. >>THIS IS MUCH BETTER, I THINK. >>I HAD ONE OTHER QUESTION AND WE MAY HAVE GLOSSED OVER IT, DAVID. DID WE TALK ABOUT THE TYPES OF -- THE WAYS IN WHICH THE INTEGRITY OF RESEARCH FINDINGS COULD BE COMPROMISED. AND WHAT I'M GOING TO TRY TO GET AT IS FOR TRIALS THERE'S CERTAIN END POINT S THAT ARE GOING TO GO TO SOCIAL MEDIA THAN OTHERS AND IN PARTICULAR I NOTICE FOR NEARLY 20 YEARS OR MORE, THERE'S BEEN A LOT OF DISCUSSION ABOUT THE SUITABILITY OF INCLUDING PATIENT-REPORTED OUTCOMES IN LABELS AND THE AGENCY HAS HAD A LOT OF CONCERNS ABOUT THE VALIDITY OF SUCH DATA AND THE REPRODUCIBILITY OF DATA AND I WONDER, SOCIAL MEDIA COULD BE AFFECTED AND PATIENT-REPORTED OUTCOMES ARE NOT SPECIFIC TO SOCIAL BEHAVIORAL RESEARCH. AND THEY'RE IMPORTANT IN THE DEVELOPMENT OF NEWER S. I WONDER IF WE CAN ACKNOWLEDGE THAT THERE'S CERTAIN END POINTS THAT MAY BE PARTICULARLY SUSCEPTIBLE TO SOCIAL MEDIA USE OR ABUSE. IS THAT CAPTURED ANYWHERE? >>NOT DIRECTLY AND I THINK IN PART BECAUSE PATIENT-CAPTURED OUTCOMES ARE DISTINCT PROCESS FROM COMMUNICATION ON SUBJECT COMMUNICATION ON SOCIAL MEDIA. AND YOU'RE ABLE -- AND YOU WON'T AFFECT YOUR HEMOGLOBIN BUT ON SOCIAL MEDIA YOU ARE ABLE TO INFLUENCE IN HOW YOU REPORT YOUR OVER ALL WELL BEING. AND REPORT THAT OR DISEASE SPECIFIC P.R.O.s. BUT THE P.R.O. TOPIC IS ONE THAT I THINK IS AN IMPORTANT ONE FOR DIFFERENT STAKEHOLDERS. >>CAN YOU COME UP WITH A QUICK ONE HERE? >>THEORETICALLY WE COULD SAY BE INFLUE INFLUENCED REPORT TO PROVIDE PATIENT REPORTED OUTCOMES THAT THEY WOULD ANOTHER WISE MIGHT HAVE. AND TO ALTER PATIENT-REPORT THE OUTCOMES I THINK THAT'S FINE. THAT'S THE CONCEPT. >>I'M CONCERNED ABOUT THIS IN GENERAL PEOPLE BEING IN A GROUP OR HAVING DISCUSSIONS MAY SELF-CONSCIOUSLY CHANGE THEIR VIEWS OR PERSPECTIVES BASED ON THAT GROUP EXPERIENCE OR HEARING OTHER PEOPLE ARTICULATE THEIR EXPERIENCES. I WORRY ABOUT ATTRIBUTING WHAT COULD JUST BE A COMMENT TO FROM ONE PERSON TO INFLUENCING PURPOSEFULLY -- >>I THINK THAT'S GENERALLY CAPTURED IN THE DOCUMENT AS A WHOLE BUT WE DON'T SPECIFICALLY MAKE THE STATEMENT YOU JUST MADE. >>WITH THE LANGUAGE THAT WAS JUST ADDED THOUGH. AND PEOPLE JUMPING TO CONCLUSIONS ABOUT AND TO WHAT SOMEONE IS SAYING ONLINE AND SOCIAL MEDIA THAT IS SOMEHOW INTENTIONAL OR WOULD CAUSE THEM TO BE VIEWED NEGATIVELY BY THE STUDY. >>THE EFFECT OF THE SOCIAL MEDIA DISCUSSIONS SO IT WOULD BE INPUT FROM OTHER SUBJECTS. >>AND INFLUENCE PROMS IN SOME WAYS. AGAIN, THAT INTERACTION WITH PEOPLE MIGHT CHANGE THEIR PERCEPTION OF THEIR EXPERIENCE. SO IS THAT INFLUENCE UNNATURAL BECAUSE OF THE INTERACTION OR ARE WE TYING THIS TO SOMETHING WE CAN CONTROL OR SHOULD BE SANCTIONING IN SOME WAY? >>PERHAPS, MIGHT BE HELPFUL TO PROVIDE A BIT MORE SPECIFICITY ON WHAT I HAD IN MIND. >>IN PRODUCT DEVELOPMENT, WHAT YOU DO IS YOUR STUDY WITH FEW EXCEPTIONS IS INTENDED TO CAPTURE THE EXPERIENCES OF INDIVIDUALS. SHE EXPERIENCES OF THE INDIVIDUALS ARE BASED UPON THEIR RESPONSE TO AN INTERVENTION OR COMPARATOR. AND THE WORE ARY AND THAT INCLUDES MEASURES SUCH AS HOW THEY'RE FEELING. THEIR SENSE OF WELL BEING OR THEIR LEVEL OF MAYBE LEVELS OF PAIN FOR EXAMPLE OR HEADACHE. AND IT'S INTENDED TO CAPTURE INDIVIDUAL EXPERIENCES AND ONE OF THE FEATURES OF SOCIAL MEDIA IS SHARING YOUR EXPERIENCE AND SHARING THE EXPERIENCE CAN I THINK AFFECT ONE'S OWN PERCEPTIONS AND RECORDING WHAT WOULD HAVE BEEN YOUR INDEPENDENT EXPERIENCE. THAT'S THE POINT I WAS TRYING TO MAKE, CONSUELO. >>I UNDERSTAND THAT. I DON'T SEE HOW WE'D BE ABLE TO DISTINGUISH IT FROM YOUR DESCRIBING YOUR FATIGUE OR INSOMNIA AND ME REALIZING, OH, THAT'S WHAT I'VE ALSO BEEN EXPERIENCING. I JUST HADN'T THOUGHT ABOUT IT TO CHECK THE FATIGUE BOX OR WHATEVER THE MARKERS NOW THAT I'M FEELING I WAS FATIGUED. I WAS ALREADY FEELING THAT I JUST HADN'T THOUGHT ABOUT IT TO ARTICULATE IT OR CHECK THE BOX. I DON'T KNOW HOW WE KNOW OR UNDERSTAND WHAT THE INFLUENCE IS HERE. I THINK ALL OF THIS IS GOING TO BE SO SUBJECTIVE FOR HOW WE WOULD -- HOW ANYONE WOULD MONITOR OR ASSESS THOSE. >>I THINK STARTING WITH LINE 53 IT'S SIMPLY A SET OF STATEMENTS OF POTENTIAL IMPACT AND THAT'S ONE OF THE IMPACT. IT DOESN'T PROVIDE IN THIS SECTION IT DOESN'T PROVIDE A SOLUTION. IT'S MORE A PROBLEM STATEMENT. >>RIGHT, BUT IF WE'RE TALKING ABOUT SCIENTIFIC VALIDITY AND THIS SOMEHOW WE WOULD DETERMINE THAT THE STUDY AND THE FINDINGS AND IT'S NO LONGER VALID BECAUSE THEY MAY HAVE BEEN INFLUENCED. I DON'T KNOW HOW YOU EVEN UNDERSTAND WHETHER OR NOT IT WAS INFLUENCED. >>IT FURTHER COMPLICATED THE PATIENT-REPORTED OUTCOMES. THAT'S THE POINT AND THAT IS SOMETHING THAT SPONSORS AND REGULATORS WOULD BE VERY SENSITIVE TO. >>I THINK CONSUELO'S POINT IS AN IMPORTANT ONE BECAUSE ONE OF THE THINGS I HEAR HER SAYING IS THAT THE INFLUENCE MAY ACTUALLY MAKE PEOPLE'S REPORTS MORE ACCURATE THERE'S AN ASSUMPTION HERE IT ALTERS THE SCIENTIFIC VALIDITY BECAUSE IT'S MAKING THE REPORTS LESS ACCURATE BUT COULD BE MAKING THEM MORE ACCURATE BY GETTING THEM TO THINK MORE DEEPLY ABOUT WHAT THEY ACTUALLY ARE EXPERIENCING. >>BI-DIRECTIONAL. >>HERE WE'RE TALKING ABOUT THE NEGATIVE EFFECTS OF SCIENTIFIC VALIDITY STARTING ON LINE 52. MAYBE IF WE ADD INAPPROPRIATELY AND LATER TALK ABOUT THE BENEFITS THAT MIGHT BE IMPROVED IF WE IDENTIFY AFFECTS IN SOME SUBJECT'S OR RESEARCH STAFF. I THINK WE GET TO CONSUELO'S POINT OF THE BENEFIT SECTION. >>THERE'S MORE POTENTIAL. >>THERE'S THE REQUEST TO SACHRP THERE WAS NOT MUCH OF AN EMPHASIS ON BENEFITS. THE MEMPHIS FROM OHRP'S QUESTIONS WAS ON PROBLEMS. WE ADDED THE BENEFIT THROUGHOUT THE RESPONSES AND QUESTIONS. AGAIN JANET'S EXPERIENCES AND INSIGHT SAYING THERE COULD BE BENEFIT TO THIS TOO. >>I DO THINK THE STATEMENT ON 63 REGARDLESS OF POTENTIAL BENEFITS AND 63 AND 64 ARE ACCURATE. >>I DON'T THINK THERE'S ANYTHING REALLY TO DISCUSS AFTER SIX. I BELIEVE AT THIS POINT WE COVERED THE DOCUMENT UNLESS ANYBODY HAS FURTHER COMMENTS. >>I THINK THE SILENCE IS AN INDICATION IT'S TIME TO HAND IT TO YOU. >>IS EVERYBODY HAPPY WITH THE CHANGES THAT HAVE BEEN MADE? LET ME PUT IT ANOTHER WAY. DOES ANYBODY THINK THIS IS NOT ADEQUATE TO MOVE FORWARD TO A VOTE? >>WOULD ANYBODY LIKE TO MAKE A MOTION TO ADOPT THIS? THERE'S ONLY FIVE OF YOU THAT CAN DO THAT. >>I'LL MAKE THAT MOTION, DOUG. IT'S AS GOOD AS IT'S GOING GET FOR A MOMENT. I THINK IT'S A FINE STATEMENT AS FAR AS IT GOES LIMITED TO THE QUESTION. I'LL MAKE A MOTION TO APPROVE. >>THANK YOU. IS THERE ANY FURTHER DISCUSSION BEFORE WE GO TO A VOTE? ALL RIGHT. HEARING, ONCE AGAIN LET'S DO A RAISE OF HANDS ALL IN FAVOR OF ADOPTING THIS DOCUMENT RAISE YOUR HANDS, PLEASE. I'M NOT SEEING CONSUELO AT ALL ON MY SCREEN? >>I'M NOT. >>SHE WAS LOWERED DOWN ON IT. >>I CAN E-MAIL HER AND ASK HER WHAT HAPPENED. >>THERE SHE IS. >>GREAT. >>IT LOOKS LIKE WE GOT DISCONNECTED. WE WERE DOING A VOTE AND WE WERE IN FAVOR OF ADOPTING THIS DOCUMENT. >>YES, I LOST MY CONNECTION IN THE MIDDLE OF MAKING A COMMENT, I THINK. I'M SORRY I MISSED PROBABLY TWO OR THREE MINUTES. IF POSSIBLE I'D LIKE TO CONFIRM WHAT A THOUGHT I WAS HEARING WAS THAT THE ISSUE I WAS BRINGING UP ABOUT SCIENTIFIC VALIDITY WAS THE BENEFITS WERE IN SOME OTHER SECTION. I JUST WANTED TO MAKE THE POINT THAT IF THERE'S A SPECIFIC SECTION ABOUT SCIENTIFIC VALIDITY IT WOULD BE IDEAL TO HAVE THE NEGATIVE AND POSITIVE ISSUES RELATING TO VALIDITY BE IN THE SAME SECTION BECAUSE AS I SEE IT HERE, SCIENTIFIC VALIDITY IS NOT LISTED UNDER NEGATIVE IMPACTS OF SCIENCE VALIDITY. SHOULD I SHARE MY SCREEN AGAIN? HERE'S HOW WE DID THE SECTION. THE QUESTION FROM OHRP IS WHAT ARE THE PRIMARY CONCERNS OF THE SUBJECT'S USE OF SOCIAL MEDIA TO DISCUSS THEIR EXPERIENCES PARTICIPATING IN ONGOING RESEARCH. WE SAID OUR CONCERNS WERE SUBJECT SAFETY ISSUES SCIENTIFIC VALIDITY ISSUES BUT THEN THERE ARE ALSO BENEFITS. AND JANET, SAID, YOU CAN'T MAKE THIS ALL NEGATIVE. THERE ARE BENEFITS. HERE WE TRIED TO CAPTURE THE BENEFITS AND EXPERIENCE TO RESEARCH AND SAFETY. >>RIGHT. MY POINT IS IF SOMEONE IS REVIEWING THE DOCUMENT AND SPECIFICALLY INTERESTED IN SCIENTIFIC VALIDITY THEY MAY NOT GO TO THE BENEFIT SECTION TO UNDERSTAND THAT'S THE POINT WE WOULD WANT TO MAKE? >>HERE'S 73 AND 74. SUCH COMMUNICATION MAY LEAD TO DISCOVERIES THAT STRENGTHEN THE VALIDITY OF THE AND NEGATIVE AND POSITIVE EFFECTS ON THE STUDY ARM. DOES THAT GET TO WHAT YOU'RE THINKING? >>YES, WITH THE ADDITION OF THE NEW BULLET IS INCOMPLETE WOULD LOOKING AT WHETHER THE INFLUENCES COULD BE POSITIVE AND NEGATIVE. >>INAPPROPRIATELY -- I ADDED INAPPROPRIATE HERE TO TRY TO ADDRESS THE NEGATIVE HERE. >>THERE'S TO IN THE SECTION SPECIFICALLY TO HAVE SOME I'D SAY ENHANCED REPORTING OUTCOMES. THERE'S A PARALLEL STRUCTURE WHICH I THINK IS ADDRESSING THIS. >>TO BE RECORDED NOT REPORTED. >>WITH A "T". >>SAME ON THE BULLET. >>CONSUELO, DOES THAT ADDRESS YOUR CONCERNS? >>I THINK IT'S FINE. I DON'T THINK IT'S IDEAL BUT I THINK IT'S FINE. >>I'LL STOP SHARING. >>BEFORE WE NOTICED YOU WERE GONE, CONSUELO, THERE WAS A MOTION TO APPROVE AND A SECOND AND WE ARE ON IN THE PROCESS OF VOTING WHEN WE DISCOVERED YOU WEREN'T ON. SO WE WILL VOTE NOW THE MOTION IS TO ADOPT THE DOCUMENT. SO I WILL ASK FOR A SHOW OF HANDS. ALL IN FAVOR AND I SEE SIX. ALL OPPOSED? AND NO ABSTENTIONS. >>I NOTICE CONSUELO'S HAND IS PERMANENTLY THERE. >>IT'S IN BETWEEN. IT'S A VERY RELUCTANT HAND RAISE. SO THAT MOTION PASSES WHICH BRINGS US TO OUR LAST ITEM OF OFFICIAL BUSINESS FOR THIS MEETING AND WE'LL SEE IF WE CAN GET THROUGH THIS TODAY OR NOT. IT LOOKS LIKE STEVEN IS HERE TO JOIN US AND TAKE US THROUGH THE ARTIFICIAL INTELLIGENCE AND HUMAN SUBJECTS RESEARCH DOCUMENT AND I BELIEVE THIS IS THE SECOND TIME THE FULL COMMITTEE IS DOING THIS AND HE'S DONE CONSIDERABLE, ALONG WITH THE SUBCOMMITTEE, CONSIDERABLE WORK ON THIS TO MEET THE CONCERNS OF OUR SACHRP PANEL FIRST TIME AROUND. STEVEN, I'LL LET YOU TAKE OVER. >>THANK YOU. AND IF PEOPLE CAN PREFER WE CAN COME BACK AND DO THIS ALL DAY TOMORROW -- >>THE CONTEXT IS DIFFERENT. THE COMMITTEE APPROVED FINAL RECOMMENDATIONS AND WE PRESENTED THE DOCUMENT AT THE LAST IN-PERSON MEETING AND HAD A LONG PREAMBLE AND IT TALKED ABOUT THE HARMS AND WE HAD CONCRETE RESPONSES TO THE ANSWERS THAT OHRP ASKED US TO THE CHARGE. AFTER A LONG DISCUSSION WE JUST DECIDED THERE WAS ENOUGH IN THE PREAMBLE THAT WAS SPECULATIVE AND REFLECTED OPINIONS FROM SUBCOMMITTEE AND THE BOARD I THINK GENERALLY AGREED WASN'T ENTIRELY COMFORTABLE WE HAD THE STANDING TO MAKE THE COMMENTS AND OBSERVATIONS. SO WE TOOK THE PREAMBLE OUT AND THE DOCUMENT YOU HAVE BEFORE YOU -- THERE'S A LOT OF THINGS OPEN. TOTALLY INVOLVED IN THE SOCIAL MEDIA DISCUSSION WHICH ACTUALLY WHILE -- OKAY, HERE WE GO. I'M GOING TO TRY TO STOP MY SHARING AND THERE WAS A COMMENT IT WAS BEING PRACTICAL FOR MONITORING SOCIAL MEDIA AND WATCHING WHAT PEOPLE WERE SAYING ABOUT TRIALS IS THE CONTEXT OF A MODERATED SESSION IN A SINGLE PLATFORM AND ONE OF THE KINDS OF THINGS YOU CAN DO WITH A.I. AND PEOPLE DO, DO. AS WITH SO MANY OF OUR THINGS THEY'RE NOT ENTIRELY UNRELATED. THIS IS THE CHANGED VERSION OF WHAT WE APPROVED LAST TIME. THIS IS WHAT WE CHANGED THE PREAMBLE TO WE TOOK IT OUT AND SAID SACHRP WAS ASKED TO RESPOND GIVEN THE CHANGE TO A.I. AND VARIED UNDERSTANDING. THE COMMITTEE DID NOT REACH CONSENSUS IN THE BACKGROUND FRAMING THAT FELT AUTHORITATIVE AND APPROVED THE CHANGES. WHAT HAPPENED AFTER THAT ON REVIEW FROM OHRP AND OTHERS THEY FELT PARTICULARLY WITHOUT THE PREAMBLE THERE WAS AMBIGUITY AND LACK OF CLARITY AND NEEDED MORE EXPLANATION. AMONG THE PARTICULARS AND WE'LL GET TO THIS WHEN YOU WALK THROUGH, THEY ASKED WE PROVIDE BETTER EXAMPLES TO EXPLAIN QUESTIONS ONE AND TWO THE ANSWERS TO QUESTIONS ONE AND TWO WHICH HAVE TO DO WITH GENERALIZABILITY AND THE REGULATORY LANGUAGE OF ABOUT WHOM AND THE DEFINIION OF RESEARCH AND HUMAN SUBJECT AND WERE APPROPRIATE TO INCORPORATE MATERIAL TO ADD TO CLARITY. I'M GOING TO GO THROUGH THIS DOCUMENT YOU HAVE ON SCREEN. CAN EVERYBODY SEE THAT. IT'S APPROPRIATE MAGNIFICATION? OKAY. NOT HEARING OTHERWISE -- SO THIS IS UP TO LINE 39. IT'S ALL JUST A RESTATEMENT OF THE CHARGE UNDER ITEM 1 UNDER A.I. OR A.I. VALIDATION ACTIVITIES WOULD MEET THE COMMON RULE DEFINITION TO CONTRIBUTE TO THE GENERALIZABLE KNOWLEDGE. FIRST I'M GOING TO GO TO THE END OF THIS QUESTION WHICH IS REALLY THE ANSWER TO IT. IT'S BEEN ARGUED A.I. VALIDATION ACTIVITIES, FRECHL FOR EXAMPLE, FOR EXAMPLE, COLLECTING DATA IS NOT GENERALIZABLE. TO ME, AND I THINK WHAT I TRIED TO CAPTURE HERE IS THAT THIS IS NO DIFFERENT THAN ANY OTHER SCIENTIFIC ENDEAVOR OF AN IN VITRO DIAGNOSTIC AND COLLECT BLOOD, TO SAY, WHETHER YOUR TEST WORKS OR NORMAL RANGES. YOU DON'T INTEND TO USE THE TEST ON THE PEOPLE EXCLUSIVELY YOU TESTED THE BLOOD FROM IN THEIR CURRENT STATE. YOUR ALWAYS DEVELOPING THINGS INFERENCES AND ALGORITHMS TO APPLY TO CERTAIN POPULATIONS EXCEPT IN SOME POPULATIONS WHERE YOU CAN MAKE THE ARGUMENT YOU WEREN'T GENERALIZING. THIS IS AN EXAMPLE OF THINKING OF A.I. DIFFERENTLY WHEN IT DOESN'T NEED TO BE THOUGHT OF DIFFERENTLY AND THE CONCLUSION IS YOU CAN READ THIS BUT IT'S THE NATURE OF DIAGNOSTIC TOOLS DEVELOPED FROM A SUBSET OF THE WHOLE POPULATION HENCE THE REQUIREMENT FOR RESEARCH PARTICIPATION AND THE DEVELOPMENT OF AN A.I., M.L. TOOL IS NOT DIFFERENT FROM A DIAGNOSTIC DEVICE AND SACHRP TAKES THE STANCE IT SHOULD HAVE THE SAME REGULATORY OVERSIGHT AND THERE'S DIFFERENCES IN HOW YOU COLLECT THE DATA BUT THIS QUESTION IS WHETHER THE RESEARCH PROJECT ITSELF SHOULD NOT BE CONSIDERED THE GENERALIZABLE KNOWLEDGE. THERE'S OTHER ISSUES ABOUT THE DATA AND WHETHER IT'S IDENTIFIED AND ALL SORTS OF THINGS BUT AS FAR AS GENERALIZABILITY GOES IT'S NO DIFFERENT THAN ANY OTHER COLLECTION OF DATA. YOU CAB SEE A NUMBER OF OTHER CHANGES IN THE PREAMBLE THAT DEAL WITH THE APPLICATION OF EXCEPTIONS AND WHY YOU DON'T GET TO GENERALIZABILITY BECAUSE YOU CONCLUDE PRESIDENT EXEMPT. THAT'S THE WORK THAT'S DONE ABOVE. AND REALLY, THEIR ONLY SUBSTANTIVE COMMENTS ON ONE AND TWO. WE WON'T DO THIS FOR ALL QUESTIONS. I DON'T KNOW IF YOU WANT ME TO STOP WITH EACH CHARGE OR GO THROUGH FIRST AND THEN COME BACK? THAT'S WHAT I'LL DO. SO THE SECOND CHARGE WAS WHEN A.I. INVOLVED SEARCH IN PRIVATE IDENTIFIABLE INFORMATION, WHEN ARE THOSE PERSONS, PRESUMABLY THE PEOPLE PROVIDING THE DATA OR ASSOCIATED WITH IT, HUMAN SUBJECTS DOES THE RESEARCH CAPTURE THE ABOVE WHOM PART OF THE SUBJECT DEFINITION, ARE THERE OTHER CONSIDERATIONS FOR THESE PERSONS? WE'RE ALL FAMILIAR WITH THE ABOUT WHOM THAT COMES FROM THE DEFINITION OF HUMAN SUBJECT. WHAT WE DISCUSSED ON THE SUBCOMMITTEE I'LL TELL YOU ABOUT THE DISCUSSION BEFORE WE I GO TO THE LANGUAGE. I THINK THE LANGUAGE AND THE ABOUT WHOM AND SUBCOMMITTEE AGRE AGR AGREED, I DON'T THINK THAT WAS SUPPOSED TO BE A POINT OF DISCRIMINATORY INFORMATION AND WHEN YOU SAY IT'S ABOUT AN INDIVIDUAL WHO USES INFORMATION, YOU'RE TALKING ABOUT THE PERSON ASSOCIATED WITH IDENTIFIERS. PEOPLE DIDN'T CONSTRUE ABOUT WHOM TO HAVE BEEN INTENDED AS A TEST. THE EXAMPLES THAT WERE RAISED BY OHRP IN BRINGING THIS BACK, WERE THINGS LIKE SOMEONE DOES MOVE AGAINST A SCREEN AND SCRAPE FACIAL IMAGES OFF THE INTERNET WITH THE INTENTION OF SAYING SOMETHING ABOUT FACIAL MORPHOLOGY IN GENERAL OR DEVELOPING A TOOL BASED ON THAT. HOW ARE THOSE FACIAL IMAGES ABOUT THOSE PEOPLE. IT'S AN INTERESTING PHILOSOPHIC QUESTION BUT NO DIFFERENT THAN WHEN YOU DRAW BLOOD FROM SOMEONE AND MEASURE THEIR SODIUM OR GLUCOSE LEVEL. YOU'RE USING CHARACTERISTICS TO DRAW CONCLUSION AND YOU GENERALLY ASSUME THE THINGS YOU COLLECT FROM PEOPLE ARE ABOUT THOSE PEOPLE. THERE ARE SEVERAL PEOPLE IN THE SUBCOMMITTEE WHO REALLY WORRIED EVEN RAISING THIS ISSUE AS A CHECK POINT AND ANOTHER THING THE IRB HAS TO CONSIDER WOULD LEAD TO JUST ENDLESS COMPLICATIONS AS PEOPLE TRIED TO JUSTIFY WHAT IT WAS ABOUT AND WHAT IT WAS NOT ABOUT. AND WE COULDN'T COME UP WITH ANY BRIGHT LINES THE IDEA WE CAN ASK THE QUESTION ABOUT FACIAL IMAGES FORGET PUBLIC VERSUS PRIVATE BUT TO SAY SOMEONE'S FACE ISN'T INFORMATION ABOUT THEM SEEMS LIKE WHY IT INVITES ANOTHER DEFINITION WE'RE IN THE USED TO USING. CAN READ WHAT A WROTE ABOUT THAT THE USE OF BIG DATA IN RESEARCH INVOLVES USING A.I. ML AND NUANCED INTERPRETATION OF THE DEFINITION AND SPECIFICALLY WHAT IS INFORMATION ABOUT INDIVIDUAL AND THEN I USED THE FACIAL THING. MORE GENERALLY, IS SPECIFIC INFORMATION COLLECTED WITHOUT ATTEMPT TO INFER ANYTHING TO INFER ABOUT PARTICULAR INDIVIDUALS IS THE BEST I COULD DO AT UNDERSTANDING THE QUESTION. THEN I MADE ME POINT IN ITEM IS AND 2 HOW IT IS ABOUT PROSPECTIVE COLLECTION OF DATA TO ESTABLISH NORMAL RANGES. THAT MAY INVOLVE INTERACTION BUT THAT'S NOT WHAT WE'RE TALKING ABOUT. THE ABOUT WHOM APPLIES TO THE INTERACTION DEFINITION AS WELL. IF THAT WAS NOT ABOUT WHOM IT WOULDN'T BE HUMAN SUBJECT RESEARCH EVEN IF IT INVOLVES INTERACTION. AND I'LL GO ON TO TALK ABOUT ASKING IF P.I.I. ABOUT AN INDIVIDUAL IS NOT ABOUT THE REGULATORY LANGUAGE. IT'S AN ASSUMPTION. THEN I TALK ABOUT PRIVATE VERSUS PUBLIC. IN READING THIS AGAIN FOR THE 500th TIME, THERE IS SOME LEAKAGE FROM THE ORIGINAL PREAMBLE SO SOME ANSWERS HAVE THINGS THAT ARE MIGHT BETTER BE PLACED IN OTHER PLACES OR COULD BE DIVIDED UP BETTER BUT THIS WAS AN APPROVED DOCUMENT SO I DIDN'T WANT TO GO BACK AND DO THAT. SO I DID MODIFY THREE. -- >>IS THERE A RECOMMENDATION UNDER TWO? A CONCRETE RECOMMENDATION OTHER THAN CAUTIONARY ON THE ABOUT WHOM ISSUE? CLEARLY THE RECOMMENDATION IS IT IS ABOUT THEM AND WE DON'T WANT TO OPEN THIS BOX. LET ME SEE IF I CAN SAY THAT MORE CLEARLY. I CAN ADD A SENTENCE THAT SAYS IN SUM -- >>THAT'S FINE. >>I THINK THAT'S IT. WANTED TO RAISE ONE OTHER THING BECAUSE JUST THIS MORNING AND YOU HAVEN'T SEEN IT YET BUT THIS PREAMBLE AND WHAT WE REPLACED THE PREAMBLE WITH BOTHERED ME BECAUSE I DON'T THINK IT'S SO COMPLICATED. AS THE ANSWERED WE JUST REVIEWED REFLECT I THINK THERE'S A MYSTIQUE AND OBSCURITY AROUND A.I. AND M.L. THAT MAKES US NOT NECESSARILY SUBJECT TO THE SAME TESTS WE APPLY EASILY TO OTHER THINGS. LET ME BRING UP DRAFT LANGUAGE THAT I HAVE IN ANOTHER DOCUMENT. >>BEFORE DO YOU THAT, WHAT IF YOU DELETED THAT AFTER SACHRP WAS ASKED TO RESPOND, PERIOD. >>THAT'S A GOOD ALTERNATIVE. I'D LIKE TO MAKE A STATEMENT IF YOU'LL ALLOW ME AND THE COMMITTEE FINDS IT COMPELLING BECAUSE I THINK IT'S WORTH SAYING. ONE THING UNDERNEATH ALL OF T THIS -- THAT'S THE SAME ONE. >>NO, IT'S DIFFERENT. >>THAT'S -- >>I CAN'T EVEN SEE WHAT I'M SHARING AT THIS POINT. LET ME FIGURE IT OUT. I THINKED THIS AND I'M GOING READ IT TO YOU BECAUSE YOU HAVEN'T SEEN IT AND IT'S NOT LONG. A.I. AND M.L. ARE A SET OF INFERENCE TO DRAW FROM DATA. THEY DIFFERENT FROM TRADITIONAL METHODS IN MAKING ASSUMPTIONS ABOUT THE DATA SUCH AS THE NATURE OF THE UNDERLYING DISTRIBUTION I WAS THINKING WHERE WE CAN USE P FAS AND OTHER THINGS BECAUSE WE HAVE THIS PROBABILITY SCIENCE THING THAT THINGS ARE NORMALLY DISTRIBUTED. WE DON'T HAVE TO DO ANY OF THAT WITH A.I. AND M.L. THE PRICE OF THIS FLEXIBILITY IS THERE'S ENORMOUS APPETITE FOR DATA. WHILE MANY OF THE UNDERLYING TECHNOLOGIES SUCH AS NEURAL NETWORKS WERE DEVELOPED DECADES AGO, UBIQUITOUS DATA COLLECTION FROM THE INTERNET AND INTERNET OF THINGS NOW PROVIDES ENOUGH DATA TO MAKE A.I. AND M.L. POWERFUL PRACTICAL TOOLS WITH THE POTENTIAL TO RAPIDLY ADVANCE SCIENTIFIC KNOWLEDGE. SACHRP ALSO ACKNOWLEDGES THE AVAILABILITY OF DATA CREATES PRESSURE ON SCIENTISTS TO USE THAT DATA TO LEARN AND TO BUILD TOOLS FOR PUBLIC AND COMMERCIAL GOOD. THERE ARE TWO UNDERLYING QUESTIONS IN THE CHARGE TO SACHRP, DO THESE NEW METHODS PRESENT ENOUGH PROMISE FOR SCIENCE AND THE PUBLIC AND THE PUBLIC GOOD TO JUSTIFY INTERPRETING THE LANGUAGE OF THE COMMON RULE TO ALLOW MORE PERMISSIVE USE OF DATA AND AS DISCUSSED UNDER ONE AND TWO, THINGS THAT I DON'T THINK WERE EVER MEANT TO BE DISTINGUISHING THINGS IN THE COMMON RULE LIKE ABOUT WHOM AND GENERALIZABILITY ARE BEING USED NOW I THINK AS WAYS BECAUSE WE HAVE IN A SENSE THIS PRESSURE. THERE'S ALL THIS DATA AND WE KNOW THERE'S A GOAL AND IT COULD BE USED FOR GREAT THINGS. AND ANYTHING THAT COULD BE A BARRIER TO THAT USE, THERE'S PRESSURE AGAINST THAT AND I THINK THAT'S WHY WE'RE TRYING TO PARS THE REGULATIONS IN A WAY THAT WE CAN FIND THIS ACCEPTABLE EVEN THOUGH THE BASIC STUFF HASN'T CHANGED BUT MAYBE IT SHOULD CHANGE. I THINK THAT'S THE OTHER PIECE. I DON'T WANT THIS DOCUMENT TO BE A BUNCH OF SAYING NO. THE ISSUE IS, IS THE POTENTIAL SO GREAT FOR GOOD THAT WE SHOULD ACTUALLY RECONSIDER HOW SOME TERMS ARE INTERPRETED. THAT'S THE POINT OF ONE. AND TWO, DOES THEIR USE, NOT JUST IN INFERENCE BUT APPLICATION OF THE INFERENCE BECAUSE THERE'S OTHER PLACES IN THE CHARGE THAT TALK ABOUT SEPARATION OF TRAINING SETS AND USE OF A.I.-BASED TOOLS, PRESENT NEW RISKS AND BENEFITS THAT ARE NOT ADEQUATELY REFLECTED IN THE RULES LANGUAGE OR ITS CURRENT INTERPRETATION? AND QUESTIONS FOUR THROUGH 10 RAISE ISSUES OF IDENTIFIABILITY AND PUBLIC VERSUS PRIVATE AND IT'S THESE SORT OF BASIC CHANGES -- IT'S NOTHIN ABOUT THE PARTICULAR ALGORITHMS BUT THE MASSIVE USE OF DATA THAT'S REALLY DRIVING THIS AND THE FACT THAT A.I. GIVES US A TOOL TO ACTUALLY USE THAT DATA NOW FOR SOMETHING THAT COULD BE VERY VALUABLE AND FORCING THESE DISCUSSIONS. I THOUGHT THIS WAS A NICE WAY TO OPEN BUT IT'S YOUR DOCUMENT. >>STEVEN, TWO QUICK COMMENTS. JUST I ASSUME THE FORMATTING -- >>DON'T WORRY ABOUT THE FORMATTING. THAT'S A WORD THING. MY COMMAND COMMENTS IS WHAT YOU JUST PRESENTED US EARLIER IS FACING AN ARGUMENT AGAINST LET'S CALL IT BIG DATA EXCEPTIONALISM. IN OTHER WORDS, YOU'RE SAYING, THIS IS NO DIFFERENT THAN GETTING -- SO WHAT'S UNCLEAR TO ME IS WHETHER YOU REALLY NEED THOSE TWO QUESTIONS. IN OTHER WORDS, YOU CAN GET RID OF THOSE UNDERLYING QUESTIONS. THAT'S YOUR INTERPRETATION. >>SO THE REASON THEY'RE THERE, SKIP, IS BECAUSE I THINK WE NEED TO TALK ABOUT WHY WE'RE BEING ASKED THESE THINGS. I THINK THERE'S REALLY, FIRST OF ALL, THERE'S A STRONG ARGUMENT TO BE MADE THAT THIS STUFF HAS UNPRECEDENTED VALUE AND WE DO NEED TO INTERPRET THINGS DIFFERENTLY TO MAKE IT EASIER TO DO. THAT WE SHOULDN'T KEEP THE SAME. I MEAN, WHAT I TALK ABOUT IN THE REST OF THE DOCUMENT IS HOW THERE'S NO REAL REASON ON THE FACE OF IT TO INTERPRET THE REGULATIONS ANY DIFFERENTLY. I THINK IT'S NOT ENTIRELY RESPONSIBLE TO SAY THAT WITHOUT ACKNOWLEDGING THE REASONS WHY WE MIGHT WANT TO DO SOMETHING. I DON'T THINK WE GET THERE BY PARSING OUT ABOUT WHOM AND GENERALIZABILITY. WE GET THERE BY REASSESSING WHETHER WE'RE APPROPRIATELY DEALING WITH THIS KIND OF INQUIRY. >>I KNOW WHAT YOU'RE INTENT IS AND A SUPPORT THE MOTIVATION BUT THE MORE WE WANDER INTO THAT SPECULATIVE WORK THE MORE WE GET BACK IN THE PROBLEM WITH THE PREAMBLE SAYING IT SHOULDN'T BE TREATED ANY DIFFERENTLY BUT -- I GUESS I DON'T SEE THOSE TWO QUESTIONS ADDING A WHOLE LOT. >>SO THERE WAS A LOT OF THAT AND LET ME GO DOWN TO THAT. >>THE INTRO HAS TO INCLUDE THAT PIECE. >>WELL, OKAY. I CAN DO THAT. I DIDN'T INCLUDE THEM BECAUSE EVERYTHING ELSE -- SO I WAS TRYING TO LEAVE OPEN -- THERE'S SOME GIVE SOME NOD TO THE REASON WE'RE BEING ASKED THIS STUFF. THAT'S SUPPOSED TO BE ALLUDED TO HERE AND I CAN MORE FULLY FLUSH OUT SOME OF THOSE RISKS. THE ONLY CONCERN I HAVE AND I ASK FOR GUIDANCE FROM YOU. MAYBE IT SHOULD BE -- I'M JUST CONCERNED THERE'S A TENSION HERE BETWEEN CONSUELO, WHAT YOU WANT TO SEE AND WHAT SKIP WANTS TO SEE. >>ALL I'M SAYING I THINK A.I. AND MACHINE LEARNING A GREAT POTENTIAL FOR GOOD AND ALSO AGREE THEY HAVE A POTENTIAL FOR RISK. ON THE OTHER HAND TO GET TO THAT DISCUSSION GETS US BACK TO THE PROBLEMS OF THE PREAMBLE AND GETTING US ALL TO AGREE ON THE LANGUAGE AND WHY INITIALLY SUGGEST THE LET'S JUST FOCUS ON THE QUESTIONS. AND THAT WAS PART OF MY MOTIVATION FOR US TO GET THE RIGHT BALANCE BETWEEN GOOD AND BAD AND OUR BIASES AND USE I THOUGHT THAT WAS GOING TO BE NEARLY IMPOSSIBLE TO DO WHICH IS WHY I RECOMMENDED IT AND GOING TO THE QUESTIONS. THE MORE IT COMES BACK IN, THE MORE WE'LL GET BACK TO THAT CONVERSATION. >>THOUGH I HAVE TO SAY, SKIP, I DON'T SEE WHAT'S SO -- I THINK IT'S NOT SUCH A BAD IDEA TO HOLD THE COMMITTEE'S FEET TO THE FIRE AND MAKE SOME STATEMENTS ABOUT THIS. I THINK THERE ARE RISKS THAT DESERVE FOR DISCUSSED AND TALKED ABOUT AND IT DOES CHANGE THE INTERPRETATION OF REGULATIONS. AND I THINK IT WAS A BIT OF A DODGE TO REMOVE ALL THAT. NOT TO SAY IT WASN'T OVERDONE AND WORDY AND ALL OF THAT AND I TOTALLY GET THAT. THERE'S OTHER PEOPLE WITH THEIR HANDS UP. LET ME COME BACK TO CONSUELO AND THEN SANDY AND WALTER. SANDRA. >>I'M SORRY I WAS NOT AT THE JULY MEETING BECAUSE I GUESS THIS WAS A BIG DISCUSSION. I'M JUST WONDERING -- I QUICKLY SCANNED THE DOCUMENT AND OF COURSE WE HAVEN'T HAD THE BENEFIT OF HAVING THIS OUT FOR VERY LONG BUT TO WHAT EXTENT IS THE OSTP BLUEPRINT FOR AND I'M SURE YOU'RE ALL AWARE OF THE DOCUMENT THAT'S COME OUT ABOUT THE DIFFERENT PRINCIPLES RELATED TO WHAT THEY'RE CALLING A.I. BILL OF RIGHTS AND IN IT I THINK THERE'S SOME INTERESTING THERE'S A LOT WITH CONSIDERATION AND FALLBACK. THE QUESTION ABOUT THE ABILITY, FOR EXAMPLE, TO EXIT OR TO TAKE ONE SELF OUT OF THE AUTOMATED SYSTEMS FROM OSTP PERSPECTIVE IDENTIFIED AS A RIGHT AND AS I SCANNED AND READ THE DOCUMENT I'M WONDERING TO WHAT EXTENT ARE WE ADDRESSING SOME OF THE ISSUES UNIQUE TO A.I. AND MACHINE LEARNING AND TO THE EXTENT WE WANT TO BE HELPFUL ABOUT THE ABILITY TO MAP ON WHAT WE'RE DOING IN TERMS OF OHRP WITH SOME OF THE OTHER UNIQUE FEATURES OF A.I. AND MACHINE LEARNING. >>IT'S A GREAT QUESTION. WE'VE BEEN WORKING ON THIS FOR A YEAR AND A HALF AND NOT TO SAY WHAT COMES FROM THE OSTP IS LIKE EVERYTHING ELSE BUT THERE'S SO MANY DOCUMENTS. WHEN WE STARTED THERE WERE QUITE A FEW FEWER. SO I HAVEN'T GONE BACK. THE OTHER THING IS I'M SURE YOU'VE SEEN THE FTC NRPM WHICH TALKS IN GREAT DETAIL ABOUT THE HARMS THAT COME FROM THIS. AND I THINK GOES BACK TO THE FACT WE'RE BEING PRESSED -- SO THIS IS MY FEELING AND MAYBE IN RESPONSE TO SOME OF SKIP'S CONCERNS, WE'RE BEING PRESSED TO ALLOW THIS AND EMBRACE IT. FIRST, BOTH BECAUSE RESEARCHERS AND SCIENTISTS WE SEE THIS IN THE COMMERCIAL SECTOR AND WE DON'T HAVE ANY CONTROL OVER IT AND MAYBE OSTP AND FTC WILL CHANGE THAT BUT THAT'S WHAT'S BEEN GOING ON IN THE PAST DECADE AND YET WE DON'T HAVE ACCESS FOR SCIENTIFIC PURPOSES AND GOOD AND THERAPY DEVELOPMENT AND STUFF BECAUSE WE'RE BEING BLOCKED BY INTERPRETATION OF RESEARCH REGULATIONS. AND I THINK THAT'S A VERY FRUSTRATING STATE FOR MANY AND ONE OF THE REASONS WHY WE WERE ASKED TO ADDRESS THIS IN THE FIRST PLACE AND TO HELP IRB'S FIND THEIR WAY THROUGH IT. I DON'T KNOW THE ANSWER TO THAT. I'M VERY FRUSTRATED AT THE ASSUMPTIONS THAT ARE MADE BEHIND THE COMMERCIAL USE THAT IT'S A BENEFIT TO EVERYBODY. WE KNOW WHO IT BENEFITS AND I'M NOT SURE IT BENEFITS THE PEOPLE WHO PROVIDE THE DATA. AND SO IT'S ONE OF THESE THINGS WHERE WE TALK IN GENERALITIES. I SHOULD CERTAINLY ADD THE OSTP DOCUMENT TO THE REFERENCES. IT WASN'T THERE WHEN I CREATE THE LIST. -- CREATED THE LIST. THE OTHER THING I HAVE TO SAY IS EVERY TIME I COME BACK TO THIS, THERE'S MORE TO ADD AND YET THERE'S -- IT'S CHANGING ALL THE TIME. I DON'T KNOW WHERE YOU ALL WANT TO STOP. YOU HAVE A DOCUMENT OUT YOU APPROVED THAT IS THE ONE WE STARTED WITH TODAY. I CAN KEEP DOING THIS. I LEARN A LOT EVERY TIME I REWRITE IT BUT AT SOME POINT -- I MEAN I'LL TAKE MY GUIDANCE FROM YOU ALL. I'M NOT SURE WHAT THE ANSWER IS BUT I THINK IT'S VERY RELEVANT. WALTER? >>THIS FIELD IS CHANGING SO RAPIDLY THAT STEVEN, YOU COULD REVISE THIS INDEFINITELY AND COME BACK TO THESE MEETINGS AND EACH TIME BE PROMPTED TO REVISE IT AGAIN. I DO THINK THE PROBLEM STATEMENT OF ESSENTIALLY THE COMMODITIZATION OF DATA IS A REAL ONE. THE PRIVATE SECTOR IS USING THESE DATA FOR OTHER PURPOSES. AND I DO THINK THIS SERVES THE DOCUMENT -- SERVES A PURPOSE FOR ENTITIES COVERED BY THE COMMON RULE. I DO PERSONALLY THINK HAVING A BRIEF PREAMBLE IS HELPFUL BECAUSE IT TOOK US A WHILE TO GET TO A POINT WHERE WE REALIZED THAT PRINCIPLES ARE REALLY NOT DIFFERENT THAN THOSE THAT WE'RE ACCUSTOMED TO. IT'S SIMPLY THE LANGUAGE AND THE TOOLS ARE OPAQUE AND THE TERMS SUCH AS A.I. AND MACHINE LEARNING ARE NOT USED WITH THE CONSISTENCY THAT WE EXPECT IN OTHER DOMAINS OF SCIENTIFIC RESEARCH. SO I AM IN FAVOR OF HAVING A BRIEF PREAMBLE LIKE THIS AND WE RUN THE RISK OF HAVING THE PERFECT BE THE ENEMY OF THE GOOD HERE AND I SUPPORT HAVING THESE BRIEF PROBLEM STATEMENTS HERE. OVER. >>SO IF WE DO THAT, I KNOW CONSUELO I KNOW THINKS WE SHOULD BE MORE UP FRONT AND NOT HAVE TO DO ITEM 8 OR 9 OR 10 OR WHATEVER THEY ARE. IS THERE ANYTHING ELSE -- WELL, I DON'T KNOW -- I'M NOT SURE WHAT THE TRAJECTORY OF THIS DOCUMENT IS BECAUSE YOU PROBABLY HAVE NOT GOING TO CONVENE AGAIN TOMORROW. SO I'M NOT GOING HAVE TIME TO MAKE SIGNIFICANT CHANGES AND WE'VE GONE BACK AND FORTH SO WE EXPECTED, TO BE HONEST, WHEN I PRESENTED WHENEVER THE LAST MEETING WAS, JUNE, THE IN-PERSON MEETING, IT HAD THE COMMITTEE HAD SEEN AND THE COMMITTEE CHANGES BUT THE COMMITTEE HAD SEEN THREE OR FOUR ITERATIONS OF THE DOCUMENT NOT QUESTIONED THE PREAMBLE. I WAS TAKEN ABACK WHEN WE TOOK IT OUT. I OFFER YOU -- I WILL DO WHATEVER YOU WANT ME TO DO I CAN ADD THINGS TO THE PREAMBLE AND THAT MEANS IT COMES BACK NEXT TIME. I CAN OR IF YOU END UP MEETING TOMORROW I CAN BRING IT BACK THEN. OR WE CAN LEAVE IT LIKE THIS OR I CAN MAKE A FEW CHANGES NOW IF YOU WANT ME TO. OR I CAN DO WHAT SKIP SUGGESTED WHICH IS TAKE THE PREAMBLE AND LEAVE THE ONE SENTENCE THAT SAYS HERE'S THE CHARGE AND THEN THE MODIFIED CHARGE. BEFORE WE DISCUSS THE PREAMBLE FURTHER WERE THERE ANY CONCERNS ABOUT THE LANGUAGE I ADDED UNDER THE CHARGES? OKAY. I'LL TAKE THAT AS A NO. THE QUESTION IS ONLY ABOUT THE PREAMBLE WHICH I ONLY ADDED LAST NIGHT SO IF I HAVEN'T DONE THAT, WE WOULDN'T HAVE THE DISCUSSION. SO I KIND OF LIKE THIS BECAUSE I THINK IT REALLY NEEDS SOME STAGE SETTING ABOUT WHY WE'RE EVEN BEING ASKED TO DO THIS BUT LEAVES A BUNCH OF THINGS OUT AND LEAVES WHAT SANDRA AND CONSUELO BOTH BROUGHT UP AS UNIQUE HARMS THAT OTHER PEOPLE ARE TALKING ABOUT. WILL WE BE SEEN AS NOT I TRIED TO FRAME IT -- IT'S REALLY, ONE, AND TWO I TRIED TO FRAME THEM POSITIVELY. BUT THEY'RE REALLY -- NOT. WHAT PEOPLE ARE CONCERNED ABOUT ARE THE HARMS. >>WHY NOT JUST KEEP IT SIMPLE THEY'RE TRYING TO INTERPRET WHY WE ASKED THE QUESTION WHICH I GENERALLY DON'T DO. I HAVE NO PROBLEM WITH A MORE BALANCED INTRODUCTION ABOUT THE CHALLENGE OF BENEFITS AND RISKS AND THAT COULD BE DONE WITH ANOTHER SENTENCE OR TWO. I DON'T SEE ANY PROBLEM WITH WHAT YOU'VE WRITTEN THERE BUT I SUGGEST TAKING OUT THE UNDERLYING QUESTIONS -- >>IF WE TAKE THESE OUT. >>AND DO TRACT CHANGES. >>TRIED TO KEEP IT SIMPLE BUT I CAN. ADDING A SENTENCE THAT BASICALLY ACKNOWLEDGES -- ACKNOWLEDGES THE HARMS AND COULD EVEN MENTION THE BILL OF RIGHTS AND ALL THAT SORT OF STUFF. STICK TO WHAT WE WERE ASKED TO ADDRESS. ADDRESSING ALL THAT OTHER STUFF IS GOING TO BE HARD TO DO. >>SO LET ME ASK A PROCESS -- OKAY, DOUG. >>I WAS GOING SAY, SKIP, IF WE'RE GOING TRY TO APPROVE THIS TODAY WE DO NEED TO WORDSMITH IT. >>THAT'S FINE. >>I'VE ALREADY STATED MY VIEW WE SHOULD GO TO THE QUESTION AND KEEP IT SIMPLE AND WE ACKNOWLEDGE THE HARMS. I THINK WE CAN DO THAT PERHAPS WITH A SENTENCE TO THE END OF THAT FIRST PARAGRAPH OR THE SECOND SHORT PARAGRAPH ON PRESSURES TO USE THE BILL HOWEVER, THEN A SENTENCE ABOUT RISKS. STEVEN, WITH ALL DUE RESPECT HAVE YOU A PROPENSITY FOR COMPLEX SENTENCES. I WOULD ASK A PERIOD AND THEN A SECOND SENTENCE. >>THANK YOU, SKIP. >>AND SAY, HOW, HOWEVER, COMMA, AND SOMETHING ABOUT THE CONCERN ABOUT THE NEED TO -- I WASN'T AWARE THERE WAS A BILL OF RIGHTS AND THAT OBVIOUSLY INDICATES TO ME THERE'S DEEP CONCERN ABOUT THE INFRINGEMENT ON INDIVIDUALS OF THESE ACTIVITIES. I GUESS RISKS AND REAL HARMS NOT JUST POTENTIAL HARMS. >>SURE. >>WELL, SO THERE HAVE BEEN REAL HARMS, I THINK IN THE COMMERCIAL SPACE. >>CONCERNS ABOUT THE IMPACT -- AND I WOULD SAY ABOUT THE NEGATIVE IMPACT. ABOUT THE HARMS. >>YEAH, ABOUT THE HARMS OF THIS -- I MEAN, JUST SAY THESE TECHNOLOGIES AND RATHER THAN TRYING TO MAKE IT COMBLI KATED JUST SAY THESE -- COMPLICATED ABOUT A.I. AND MACHINE LEARNING. >>IT BE A FRANCHISE THIS WAS IN THE PRIOR PREAMBLE. THE USE OF DATA IS NOT APPROPRIATELY REPRESENTED AND COLLECTED OR USED IS USED IN AN UNBALANCED OR COLLECTED IN AN UNBALANCED WAY FROM SOME GROUPS AND THAT'S A HUGE ISSUE. >>STEVEN, THAT IS TRUE BUT -- >>SO HOW'S THIS. I WOULD ASK CONSUELO AND SANDRA WHAT THEIR THOUGHTS ARE ON THIS AND THEY'RE MORE IN TUNE WITH THIS THAN I AM. >>WELL, SO I GUESS -- I THINK IT'S REALLY IMPORTANT TO FOR THE OSTP A.I. BILL OF RIGHTS TO BE INCLUDED AS A REFERENCE. BY PUTTING IT IN THE PREAMBLE IT SUGGESTS WE HAVE SOMEHOW TAKEN THAT TO CONSIDERATION IN OUR RESPONSES BELOW SO I'M A LITTLE BIT CONCERNED ABOUT THAT. AND THAT'S WHERE I THINK SOME OF THE OTHER EFFORTS ARE COMING FROM. >>DATA BIAS, INEQUITIES AND -- >>THE IDEA IS THAT IT REINFORCED EXISTING DISCRIMINATION. IS THAT THE BEST WAY TO SAY IT. >>THERE'S DISCRIMINATION TO EXISTING BECAUSE THERE IS EVIDENCE THAT A.I. CAN DO IT ON ITS OWN. >>I WOULD ADD DISCRIMINATION AS A DATA BIAS IS ITS OWN CONCEPT. DISCRIMINATION AS THE SECOND ONE. IT'S NOT MEANT TO BE A COMPLETE LIST. >>SO HOW ABOUT, FOR EXAMPLE, DATA BIAS DISCRIMINATION REINFORCEMENT OF EXISTING INEQUITIES -- INEQUITY. >>COULD CAUSE -- IF IT'S NOT MEANT TO BE EXHAUSTIVE I UNDERSTAND. >>PERPETUATING INEQUITIES. >>OKAY. THAT'S WHAT I MEANT BY REINFORCEMENT BECAUSE IT CARRIES IT FORWARD FOREVER ONCE YOU PUT IT IN THE DATA SET. >>AND NEW INEQUITIES. >>HOW ABOUT REINFORCEMENT OF INEQUITY? >>OR YOU COULD EVEN SAY REINFORCING EXISTING INEQUITIES AND CREATING NEW ONES OR SOMETHING ALONG THOSE LINES. >>DATA BIAS DISCRIMINATION AND -- OKAY, DATA BIAS, DISCRIMINATION >>ENFORCEMENT IS IMPORTANT. IT COMES OUT OF THE NATURE OF THE THING. IT TAKES DATA AND IT'S NATURALLY DOING TO USE THE SAME THING EVERY TIME GOING FORWARD. I THINK THE REINFORCEMENT -- IT WILL REINFORCE ALL THIS. >>IT ALSO CREATES NEW INEQUITIES. >>WHERE YOU HAVE THE FIRST WORD INEQUITY BUT CREATION THERE. GET RID OF EXISTING -- >>OKAY. >>JUST PUT CREATION. >>AND REINFORCEMENT. >>OKAY. YOU SHOULD HAVE INSISTED I LISTEN TO YOU, SKIP. I TRIED. IT'S ALWAYS A CHALLENGE. >>I'M IN MY HEAD THINKING COMPLEX LANGUAGE. >>I'M NOT SURE WHAT DATA BIAS MEANS HERE. LACK OF REPRESENTATIVENESS. >>WALTER, GOING BACK TO THE EARLIER PREVIEW WITH THE WAY DATA'S COLLECTED, YOU DON'T KNOW, UNLIKE CONTROLLED EXPERIMENT WHERE YOU CONTROL WHERE YOU GET THE DATA, YOU DON'T KNOW WHETHER IT'S REPRESENTATIVE OR NOT BUT YOU APPLY IT. >>YES, SOMETIMES YOU DO KNOW THAT IT IS. >>SOMETIMES YOU DO AND THEN THAT'S JUST BAD METHODOLOGY. >>THE TERM DATA BIAS IS JARGON. >>AND TAKE IT OUT? >>WE COULD REFER TO -- >>HOW ABOUT JUST BIAS? INTERROGATED BY A.I.E DATA BEIN- THAT'S CUMBERSOME BUT THAT'S THE IDEA. >>THAT'S THE ORIGINS OF THE HARMS BUT WHAT ARE THE CAUSE OF THE HARMS? IS THIS SENTENCE GOOD ENOUGH? IT WOULD BE NICE TO BE ABLE TO TO GET FOUR HOURS BACK TOMORROW. >>THE DATA BIAS JARGON PERHAPS BUT I THINK WE RUN THE RISK OF SPENDING A LOT OF MORE TIME -- IT COULD BE BIAS IN THE SAMPLE OR IN THE DATA SET THE WAY IT WAS RETRIEVED AND IMPUTED, THE MODELS, THE LABELLING. THE POINT IS THESE ARE THE HARMS. I'M NOT CONCERNED ABOUT THE METHODOLOGICAL TERMS. >>WE DON'T CARE ABOUT BIAS IN THE DATA WE CARE ABOUT WHAT HAPPENS TO THE PEOPLE AS A RESULT OF THE BIAS IN THE DATA. >>I KIND OF LIKE THE WAY THIS READS. >>MY PREVIOUS APPROACH IN THE LAST MEETING DIDN'T STICK. IF YOU ADD YOU'RE IN A DIFFERENT DOCUMENT NOW -- I CONTROLLED BACK BECAUSE I WANT TO ADD A NOTE TO PUT IN THE OSTP REFERENCE. >>I CAN GO BACK TO SHOW YOU THE TRACK. >>I WANT TO MAKE SURE AND LOOK AT THE ONE WE'RE APPROVING. HERE'S THE PART ABOUT NUANCED INTERPRETATION OF AND WHAT JULIA SENT OUT AND CHANGE IS ACCEPTED AND I PUT MY ADDITIONAL PREAMBLE ON TOP OF THIS. >>THEN YOU WANT TO ADD -- >>UNDER FIVE REFERENCES I HAVE THESE THINGS AND I THINK IT'S ENTIRELY APPROPRIATE TO ADD THE OSTP REFERENCE BUT I HAVE TO DO IT OFFLINE AND SEND IT BACK OUT. >>WHAT ABOUT THE FTC? >>I DON'T KNOW -- I CAN DO THAT. IT'S AN NRPM SO I DON'T KNOW WHAT HAPPENS TO IT. I GUESS IT WILL ALWAYS BE THERE AND WE CAN ADD A REFERENCE TO IT. IT'S QUITE EXHAUSTIVE, IT'S 125 PAGES. I THINK IT WAS GREAT AND LONG OVERDUE AS I THOUGHT ABOUT THE OSTP AS WELL. >>OKAY. DOUG, ARE YOU WILLING TO ENTTRAIN -- ENTERTAIN A MOTION OF APPROVAL WITH THE CHANGES DISCUSSED? >>I AM AND IT SOUNDS LIKE YOU'RE DOING THAT. >>MY LAST MOTION DIDN'T STICK. >>IT WASN'T MY FAULT. I DID NOT WANT TO BRING THIS BACK. ARE THERE ANY OTHER CHANGES BEFORE WE MOVE TO A VOTE? THEN SKIP, WHY DON'T YOU MAKE A MOTION. >>A MOTION FOR APPROVAL AS AMENDED WITH THE PREVIOUS CHANGES WE SAW IN CHANGES. >>IS THERE A SECOND TO THAT MOTION? >>SECOND. WE HAVE A MOTION TO APPROVE THIS DOCUMENT WITH THE CHANGES THAT WE HAVE JUST MADE. AND ACCEPTING THE CHANGES YOU SAW EARLIER WITH THE ADDITION TO THESE TWO REFERENCES. SO WE WILL MOVE TO A VOTE. ALL IN FAVOR -- I CAN'T SEE THE WHOLE SCREEN. I DON'T KNOW IF YOU CAN JULIA. >>LET ME STOP SHARING AND YOU'LL BE ABLE TO SEE IT. >>I'M SEEING SIX. ALL OPPOSED? >>THE MOTION PASSES. EXCELLENT. THAT CONCLUDES THIS BUSINESS FOR TODAY. MY UNDERSTANDING AND JULIA, CORRECT ME IF I'M WRONG, IS THAT WE HAVE NO PUBLIC COMMENTS TO REPORT OUT. >>WE DO NOT. >>AND -- WAS THERE A PUBLIC COMMENT PERIOD FOR TOMORROW THAT SOMEHOW WE HAD TO SHOW UP FOR FIVE MINUTES -- >>NO, THE ENTIRE AGENDA WAS DONE TODAY SO WE'RE DONE. THERE'S NO NEW TOPICS THAT WOULD HAVE BEEN DISCUSSED TOMORROW. >>OKAY. AND TO BE CLEAR THE PUBLIC COMMENT PER THE FEDERAL REGISTER ANNOUNCEMENT FOR THE MEETING NEEDED TO BE SUBMITTED IN ADVANCE SO I WOULD HAVE REGARDLESS OF WHAT DATA TOPIC IT WAS ON. >>GREAT. >>WELL, BEFORE WE ADJOURN, I JUST WANT TO THANK EVERYBODY FOR YOUR GOOD WORK. THIS WAS A VERY PRODUCTIVE MEETING WITH THE APPROVAL OF TWO DOCUMENTS AND THE APPROVAL OF TWO SETS OF SETS OF RECOMMENDATIONS ON AS ALWAYS MANY THANKS TO THE SUBCOMMITTEES AND AUTHORS OF THE DOCUMENTS WHO PUT IN A TON OF WORK AND TO THE OHRP STAFF, PARTICULARLY JULIA WHO WAS BEHIND THE SCENES MAKING THIS WORK. DID YOU WANT TO SAY ANYTHING IN CLOSING? >>I'D LIKE TO JOIN YOU IN THANKING EVERYBODY AND GREAT WORK AND LOOK FORWARD TO USING ALL OF THIS. THANK YOU. LET ME NOTE THE NEXT SACHRP MEETING IS SCHEDULED TO BE AN IN-PERSON MEETING AND THAT'S MARCH 22 AND 23. I DO HOPE THAT BY THAT POINT WE'LL BE BACK UP TO 11 SACHRP MEMBERS. WE'LL SEE. MAKE SURE YOU HAVE MARCH 22 AND 23 RESERVED ON YOUR CALENDAR FOR AN IN PERSON MEETING HERE IN BETHESDA. >>IS THERE ANY RISK THAT COULD CHANGE? OR IS THAT FAIRLY CERTAIN? WE'RE PART OF IT. THE IN PERSON PART? IF A TERRIBLE WEATHER REPORT EMERGES CAN SHIFT AT THE LAST MINUTE. >>MARCH IN BETHESDA, I HOPE NOT. >>IT CERTAINLY CAN HAPPEN. THE INTENT AT THIS POINT IS TO HAVE AN IN PERSON MEETING. IF THAT DOES CHANGE I'LL CERTAINLY LET YOU KNOW BUT I'LL LET EVERYBODY TO TRY TO CIRCLE THE DATES ON THEIR CALENDARS ACCORDINGLY. >>WONDERFUL, THANK YOU. >>THANKS, AGAIN, EVERYBODY. I THINK WE CAN CONSIDER OURSELVES TO BE OFFICIALLY ADJOURNED. >>THANK YOU. >>THANK YOU.