>> WELCOME, I'LL CALL THE MEETING TO ORDER. FIRST OF ALL, APOLOGIES TO EVERYBODY FOR THE LATE START. THERE'S ALWAYS SOMETHING. THANK YOU TO THE PANELISTS WHO ON VERY SHORT NOTICE AGREED TO JOIN US TODAY. WE'RE GOING TO TALK ABOUT TRANSITION PROVISIONS, YOU'VE ALL SEEN SOME OF THE DOCUMENTS, BUT I THINK WE'RE DOWN TO THE WIRE HERE, AND THE CLOSER WE GET SORT OF THE MORE AWARE WE'VE BECOME OF SOME REALLY POTENTIALLY CONFUSING AND DISRUPTIVE THINGS. AND WE'RE NOT -- WE DON'T HAVE THE EXPECTATION THAT WE'RE GOING TO RESOLVE THEM BUT I THINK IT'S MORE IMPORTANT FOR OUR CONVERSATION TO BE RECORDED SO THAT PEOPLE ARE AT LEAST AWARE OF SOME OF THE ISSUES AND CAN THINK ABOUT HOW WE'RE GOING TO MAKE THIS WORK AS EASILY AS POSSIBLE. SO, AGAIN, THANK YOU ALL FOR COMING ON SHORT NOTICE. JERRY? >> I WANT TO ECHO YOUR THANKS, STEPHEN AND THANK EVERYBODY WHO HAS BEEN WORKING SO HARD BEHIND THE SCENES SINCE THE LAST SACHRP MEETING. IT'S AN ONGOING PROCESS OF PREPARING DRAFT GUIDANCE DOCUMENTS THAT WILL HELP EVERYBODY SMOOTHLY ROLL OUT AS THIS RULE GRADUALLY GOES INTO EFFECT. I PARTICULARLY WANT TO THANK THE SACHRP SUBCOMMITTEE MEMBERS, THE MEMBERS OF SACHRP THAT HAVE BEEN WORKING WITH THE SUBCOMMITTEE MEMBERS. [ NO AUDIO ] >> THROUGH A BRIEF POWERPOINT PRESENTATION THAT GIVES BACKGROUND ABOUT THE TRANSITION. WE'RE GOING TO TURN IT OVER TO THE PANELISTS AND EACH OF THEM WILL TAKE WHATEVER TIME THEY NEED, FIVE OR TEN MINUTES PROBABLY EACH, TO TALK ABOUT THEIR CONCERNS, AND WHAT THEIR ORGANIZATION HAS DONE OR THINKS SHOULD BE DONE, WHAT THEY THINK SHOULD BE DONE, ABOUT THE TRANSITION PROVISIONS AND TRYING TO IDENTIFY AMBIGUITIES AND POSSIBLE RESOLUTIONS IN SOME OF THE TRANSITION ISSUES. WE'LL TAKE A BREAK AND COME BACK AND HAVE A FULL DISCUSSION WITH THE PANEL, AND ALSO WE HAVE A DRAFT DOCUMENT WHICH IS ABOUT 10 SINGLE-SPACE PAGES LONG, THE PRODUCT OF CONVERSATIONS THAT THE SUBCOMMITTEES HAVE HAD ABOUT THE -- WITH ESSENTIALLY AN EXPLANATION OF PROBLEMS AND AMBIGUITIES AND SOME RECOMMENDATIONS THAT THE SUBCOMMITTEES ARE FORWARDING TO SACHRP FOR POTENTIAL ACTION AT THIS MEETING. SO THAT'S HOW WE'RE GOING TO HANDLE THIS. STEPHEN, IS THAT OKAY WITH YOU? OKAY. SO LET ME JUST START BY BRIEFLY INTRODUCING THE PANELISTS. ALBERT ALLEN IS A SENIOR MEDICAL FELLOW IN MEDICINES DEVELOPMENT AT LILLY AND HAS BEEN A MEMBER OF SACHRP AND ALSO OF THE SUBCOMMITTEES FOR A LONG PERIOD OF TIME, A.J. YOUR TIME ON SACHRP AS A MEMBER HAS STOPPED BUT YOU'RE STILL A MEMBER OF THE SUBCOMMITTEE. PARTHENA PSYLLOS WHO IS A FRIEND OF MINE AND COMES FROM PFIZER, SENIOR CORPORATE COUNSEL AT PFIZER, MEGAN KASIMASIT SINGLETON, OFFICE OF HUMAN SUBJECTS RESEARCH AT JOHNS HOPKINS, TIM CHULINDRA, HEALTH SCIENCES, A WELL-KNOWN CRO, HEATHER PIERCE, SENIOR DIRECTOR FOR SCIENCE POLICY AND REGULATORY COUNCIL AT ASSOCIATION FOR MEDICAL COLLEGES, AND FILLIVE DESJARDINS, FROM JOHNSON AND JOHNSON. SO THANK YOU ALL VERY MUCH FOR BEING HERE. IF YOU WANT TO SAY MORE ABOUT YOURSELVES, WHEN IT'S YOUR TIME TO TALK PLEASE FEEL FREE, ESPECIALLY IF YOU THINK IT'S RELEVANT TO THE BACKGROUND BUT THAT'S JUST A BRIEF INTRODUCTION. SO, I GUESS WHAT I SHOULD SAY IN STARTING IS THAT BECAUSE THIS IS THE TIME FOR CONFLICT DISCLOSURE, IS THAT I PERSONALLY AM CONFLICTED IN EVERY POSSIBLE WAY ABOUT THIS ISSUE BECAUSE I REPRESENT LOTS OF PHARMA, UNIVERSITIES, ACADEMIC MEDICALLERS IS, RESEARCH INSTITUTES, I'M CONFLICTED, YOU CAN IGNORE WHAT YOU WANT, WHATEVER I SAY, OR INTERPRET IT IN LIGHT OF MY COMPLETE AND UTTER CONFLICT IN REGARD TO THESE ISSUES. SO WITH THAT SAID, LET ME -- WE'RE GOING THROUGH THIS PRESENTATION TO GIVE YOU SOME BACKGROUND. THERE WE GO. OKAY. SO, THIS IS THE AGENDA FOR THE BRIEF BACKGROUND PRESENTATION, WE'LL TALK ABOUT THE COMPLEXITY CREATED BY THE TRANSITION PROVISIONS, WE'LL TALK ABOUT THE CONSENT REQUIREMENT, WE'LL TALK ABOUT THE POTENTIAL HARMONIZATION, SO CALLED, BETWEEN THE COMMON RULE AND FDA REGULATIONS, ABOUT ALL OF THE PROVISIONS OF THE REVISED COMMON RULE BUT FOCUSING ON THE INFORMED CONSENT ISSUES BECAUSE THAT'S WHAT'S BEFORE US TODAY. AND FINALLY RECOMMENDATIONS. SO, THE REASON WE'RE HERE TODAY IS BECAUSE IN THE PROCESS OF LOOKING AT, EXAMINING, DISCUSSING THE TRANSITION FROM OLD COMMON RULE TO REVISED COMMON RULE SACHRP AND COMMITTEES ARE AWARE OF PROBLEMS CONDITIONS AND INSTITUTIONS HAD IN REGARD TO THESE TRANSITION PROVISIONS. THERE ARE AMBIGUITIES BECAUSE THE TRANSITION PROVISIONS ARE BRIEFLY EXPRESSED IN THE REVISED COMMON RULE BUT THERE'S STUFF TO UNPACK WITH RESEARCH INSTITUTIONS, COMPANIES, IRBs SHOULD BE DOING AND THINKING ABOUT. WE DO AT THE END OF THIS RECOMMEND THERE BE SOME RECOMMENDATIONS ISSUED BY POTENTIALLY OHRP AND/OR FDA IN REGARD TO SOME OF THE ISSUES, ALTHOUGH I THINK IT'S ALSO SAFE TO SAY THAT IN MANY CASES EVEN WHEN OHRP HAS NOT ISSUED FORMAL GUIDANCE, BASED ON SACHRP RECOMMENDATIONS, NEVERTHELESS THE SACHRP RECOMMENDATIONS ALONE STAND OUT THERE AS A POTENTIAL SOURCE OF PERSUASIVE AUTHORITY FOR THE ENTIRE RESEARCH COMMUNITY, EVEN IF NOT ADOPTED VERBATIM OR IN PART BY THE REGULATORY AGENCIES. SO PART OF THE PURPOSE OF TODAY'S SESSION IS NOT ONLY TO MAKE RECOMMENDATIONS TO FDA, TO OHRP AND REALLY TO THE HHS SECRETARY WHO OVERSEE THE BOTH BUT ELUCIDATE AND RECOMMEND REASONABLE SOLUTIONS THAT THE ENTIRE RESEARCH COMMUNITY HOPEFULLY CAN CONGREGATE AROUND AND SUPPORT. SO, WITH THAT SAID, LET'S TALK ABOUT SOME OF THE COMPLEXITIES FOR A SECOND. WE KNOW THAT THE COMMON RULE WAS PROMULGATED IN JANUARY OF 2017, COMPLIANCE DATE SLATED FOR JANUARY 21 OF 2019, WHICH IS THREE OR FOUR MONTHS AWAY. WE ALSO KNOW THAT RESEARCH THAT IS INITIATED ON OR AFTER JANUARY 21, 2019, MUST COMPLY WITH THE COMMON RULE, REVISED COMMON RULE REQUIREMENTS EXCEPT FOR THE COOPERATIVE RESEARCH REQUIREMENT WHICH TAKES EFFECT IN JANUARY OF 2020. WE ALSO KNOW THAT RESEARCH INITIATED BEFORE THE COMPLIANCE DATE OF JANUARY 21, 2019, REMAINS SUBJECT TO THE PRE-2018 OLD COMMON RULE PRE-REVISION REQUIREMENTS WITH TWO EXCEPTIONS. SO, FIRST OF ALL, INSTITUTIONS HAVE BEEN ABLE AFTER THE ADOPTION OF THE FINAL REVISED COMMON RULE TO IMPLEMENT THREE SO-CALLED BURDEN-REDUCING PROVISIONS OF THE NEW COMMON RULE. THEY HAVE BEEN ABLE TO DO THIS SINCE JULY 19 OF 2018. THESE THREE BURDEN-REDUCING PROVISIONS INCLUDE THE CHANGE OF THE DEFINITION OF RESEARCH WHICH EXCLUDE CERTAIN ACTIVITIES IN THE DEFINITION OF RESEARCH AND THEREFORE EXCLUDES OR PREVENTS NECESSITY OF IRB REVIEW AND APPROVAL. NUMBER TWO, THE ELIMINATION OF THE NEED FOR ANNUAL CONTINUING REVIEW IN CERTAIN CASES, IN GENERAL IN REGARD TO LOWER RISK RESEARCH. AND THIRD IS ELIMINATING THE REQUIREMENT THAT IRBs REVIEW GRANT APPLICATIONS AND FUNDING PROPOSALS, THREE OF THE BURDEN-REDUCING PROVISIONS. STUDIES IN WHICH THESE THREE PROVISIONS HAVE BEEN ELECTED TO BE USED BY INSTITUTIONS MUST THEN ABIDE AS PART OF THE DEAL BY WHICH THEY GET ACCESS TO THE BURDEN-REDUCING PROVISIONS, THEY MUST THEREFORE ABIDE BY THE FULL SET OF REVISED REGULATIONS AS OF JANUARY 21, 2019. NOW, INSTITUTIONS CAN ALSO CHOOSE TO TRANSITION STUDIES INITIATED BEFORE 21, 2019, TO THE REVISED COMMON RULE EVEN IF THEY HAVE NOT AVAILED THEMSELVES THE THREE BURDEN-REDUCING PROVISIONS. SO, IF THERE IS A STUDY THAT IS ONGOING, THEN AS OF BEFORE THE TRANSITION DATE, IT'S ALREADY BEEN INITIATED, THEN THE INSTITUTION CAN DECIDE TO BEGIN TO TREAT THE STUDY UNDER THE REVISED COMMON RULE PROVISIONS EVEN IF THE INSTITUTION HAS NOT AVAILED ITSELF OF THE THREE BURDEN-REDUCING PROVISIONS. THE ELECTION IS IRREVERSIBLE. THEY CAN'T GO BACK AND FORTH. IT CAN BE DONE BY INSTITUTIONS ON A STUDY-BY-STUDY BASIS OR A GROUP OF STUDIES OR ALL THE STUDIES BEING CONDUCTED UNDER THE JURISDICTION OF THAT INSTITUTION. IN TERMS OF WAIVER OF INFORMATION CONSENT, REMEMBER THAT THERE ARE REVISIONS TO THE INFORMED CONSENT PROVISIONS, ONE OF THE REVISIONS IS THE REVISION IN THE CRITERIA FOR WAIVER OF INFORMED CONSENT. UNDER THE REVISED COMMON RULE IRBs MUST DETERMINE RESEARCH COULD NOT BE CARRIED OUT WITHOUT IDENTIFIABLE INFORMATION IN ORDER TO GRANT A WAIVER, IN ADDITION TO THE OTHER CRITERIA THAT EXISTED IN THE OLD COMMON RULE. NOW, ONE OF THE AMBIGUITIES HERE IS HOW THE REVISED WAIVER CRITERIA APPLY TO STUDIES THAT TRANSITION TO THE REVISED COMMON RULE. QUESTION HERE IS WOULD STUDY BE REQUIRED TO OBTAIN REFRESHED WAIVERS, IN OTHER WORDS WOULD AN IRB NEED TO RECONSIDER THE WAIVER UNDER THE NEW CRITERIA, WITH THE NEW CRITERIA, WITH THE NEW CRITERION ADDED, IN THE FIRST BULLET HERE, EVEN IF A WAIVER HAD BEEN GRANTED ALREADY UNDER THE PRE--- UNDER THE OLD COMMON RULE. NOW, THE RECOMMENDATION -- THESE ARE DRAFT RECOMMENDATIONS. THESE ARE FOR DISCUSSION. THEY ARE FOR DISCUSSION BY THE PANEL. THEY ARE FOR DISCUSSION BY SACHRP, YOU KNOW, SO ANY OF THIS CAN BE -- IT'S ALL WRITTEN ON WATER, IT CAN ALL BE CHANGED, RIGHT? BUT THE DRAFT RECOMMENDATION IS THAT A STUDY PREVIOUSLY GRANTED AND INFORMED CONSENT WAIVER UNDER THE OLD COMMON RULE SHOULD BE PERMITTED TO CONTINUE TO RELY ON THAT WAIVER AFTER THE ADVENT OF THE NEW COMMON RULE, EVEN WHEN THE STUDY TRANSITIONS. OKAY, THAT'S THE BEST OF THE RECOMMENDATION. WE CAN TALK ABOUT RATIONALE FOR THAT, WE'LL GET INTO THAT IN THE PANEL DISCUSSION. THERE IS ALSO A NEW REQUIREMENT THAT IN REGARD TO INFORMED CONSENT, BECAUSE AGAIN WE'RE FOCUSING ON THAT TODAY, THAT CONSENT FORMS FOR RESEARCH THAT IS CONSIDERED TO BE A CLINICAL TRIAL BE POSTED ONLINE TO PROMOTE TRANSPARENCY IN THE CLINICAL TRIAL ENTERPRISE AND HOPEFULLY TO, WITH THIS AVAILABILITY OF FORMS, WE CAN THEN UNDERSTAND WHAT OTHERS ARE DOING, CAN COMPARE BEST PRACTICES, CAN DERIVE BEST PRACTICES AND UNDERSTAND WHAT MAYBE DOESN'T WORK AS WELL THROUGH EXAMINING THESE FORMS POSTED ONLINE. UNDER THE NEW COMMON RULE THE FORM MAY BE POSTED AFTER THE STUDY ENDS, NO LATER THAN 60 DAYS AFTER THE LAST STUDY VISIT BY ANY SUBJECT. IT IS NOT ALL THE FORMS DURING THE COURSE OF THE STUDY THAT MUST BE POSTED, IT IS ONE FORM, AT LEAST ONE FORM THAT HAS BEEN USED AND APPROVED BY AN IRB DURING THE COURSE OF THE STUDY, AS I UNDERSTAND IT. NOW, IT'S UNCLEAR FOR STUDIES INITIATED BEFORE JANUARY 21 OF 2019 THE -- WHICH CONSENT FORMS MUST BE POSTED ONLINE AND WHEN THEY MUST BE POSTED. SO HOW THIS POSTING REQUIREMENT APPLIES TO THESE STUDIES THAT WERE INITIATED BEFORE THE COMPLIANCE DATE, HOW DOES THE POSTING REQUIREMENT APPLY TO THEM. HERE IS THE DRAFT RECOMMENDATION. FIRST OF ALL, STUDIES THAT TRANSITION TO THE NEW RULE SHOULD BE REQUIRED TO POST THE CONSENT FORMS CONSISTENT WITH THE NEW RULE. THE SECOND PIECE OF THIS IS IF RECRUITMENT HAS ENDED, WHEN AT THE TIME THE TRIAL IS TRANSITIONED, THE POSTING SHOULD BE MADE NO LATER THAN 60 DAYS AFTER THE LAST STUDY VISIT. NOW, I DO WANT TO AMEND THIS BECAUSE AS I LOOKED AT THIS THIS MORNING PREPARING FOR THIS, THIS LEAVES OUT ONE PIECE, WHICH IS WHAT IF THE TRIAL TRANSITIONED AND THE LAST STUDY VISIT HAPPENED AND 60 DAYS HAVE ELAPSED, AND YET WE'RE STILL NOT TO THE TRANSITION DATE? SO IN THAT CASE, WHAT ONE WOULD DO I THINK WITH THIS RECOMMENDATION, IF YOU WANT TO ABIDE BY IT OR KEEP IT, WOULD BE YOU WOULD SAY, ONE WOULD SAY IF WE SAY IF RECRUITED HAS ENDED, 60 DAYS, WHICH EVER IS LATER, THAT'S WHAT WE WOULD SAY. IF RECRUITMENT IS ONGOING, WHEN THE TRIAL IS TRANSITIONED, RESEARCHERS SHOULD BE REQUIRED TO POST THE VERSION OF THE CONSENT USED FOLLOWING THE TRANSITION IN THE SAME WAY UNDER THE SAME COMMON RULE REQUIREMENT, THAT IS ANYTIME BUT MUST DO IT NO LATER THAN 60 DAYS AFTER THE LAST STUDY VISIT. THEN THERE'S THE ISSUE OF RECONSENT, IN TRANSITION STUDIES. IT'S UNCLEAR WHETHER ONGOING STUDIES THAT TRANSITION AT THE REVISED COMMON RULE WILL NEED TO RECONSENT SUBJECTS WHO ARE CONSENTED INTO THE STUDY USING A FORM THAT ABIDED BY THE OLD COMMON RULE REQUIREMENTS BUT AT THE TIME THE CONSENT WAS USED WAS NOT ABIDING BY THE NEW INFORMED CONSENT REQUIREMENTS. SO HERE'S THE RECOMMENDATION. OBTAINING BRAND NEW CONSENT FOR SUBJECTS ALREADY CONSENTED BEFORE THE TRANSITION, OBTAINING THOSE NEW CONSENTS SHOULD NOT BE REQUIRED. THEY WERE ALREADY CONSENTED UNDER THE OLD RULE, THAT SHOULD BE EFFECTIVE FOR THE NEW RULE, FOR THE POST-TRANSITION PERIOD FOR THAT STUDY. BUT IF AN IRB CALLS FOR OBTAINING NEW CONSENT FOR ANOTHER REASON BECAUSE, FOR EXAMPLE, EVERYONE SHOULD BE RECONSENTED BECAUSE RISKS AND BENEFITS OF THE STUDY CHANGED IN SOME MATERIAL WAY, THEN THE NEW FORM THAT WOULD BE USED FOR ALL SUBJECTS IN THE RECONSENT WOULD ABIDE BY THE PROVISIONS OF THE REVISED COMMON RULE. THAT'S THE RECOMMENDATION. NOW, ONE OF THE OTHER -- AND THIS IS ARTICULATED MORE FULLY IN THE LENGTHY PROSE DOCUMENT YOU HAVE BUT ONE OF THE BOTTOM LINES HERE IN TERMS OF THE DISCUSSIONS THAT THE SUBCOMMITTEES AT LEAST HAVE HAD IS THAT IT'S OUR FEELING THAT BECAUSE OF THESE AMBIGUITIES IT IS GENERALLY BETTER, AND THIS IS A GENERAL RECOMMENDATION, PEOPLE DON'T HAVE TO FOLLOW IT, INSTITUTIONS AND IRBs DON'T HAVE TO FOLLOW IT BUT THE RECOMMENDATION IS THAT IF A STUDY HAS ALREADY BEEN INITIATED UNDER THE OLD COMMON RULE, IT IS BETTER TO ALLOW IT TO STAY UNDER THE OLD COMMON RULE TO ELIMINATE ALL OF THESE AMBIGUITIES FOR THAT STUDY. SO THIS IS THE GENERAL RECOMMENDATION. OTHERWISE, WE WILL END UP WITH SO MANY PERMUTATIONS AND COMBINATIONS OF STUDIES IT WILL BE INCREASINGLY DIFFICULT AS WE MOVE TOWARD THE TRANSITION DATE AND AFTER THE TRANSITION DATE FOR EVERYONE TO KEEP ALL THEIR OBLIGATIONS STRAIGHT AND MAKE SURE THEY ABIDE BY THEM. IN TERMS OF THE CONSENT REQUIREMENT, REMEMBER WHAT THE NEW CONSENT REQUIREMENTS ARE IN TERMS OF THE CONTENT OF THE ICF. THE REVISED COMMON RULE REQUIRES ICFs BEGIN WITH CONCISE STATEMENT OF KEY INFORMATION A SUBJECT MIGHT WANT TO KNOW. THE STATEMENT SHOULD INCLUDE ACCORDING TO REVISED COMMON RULE CONCISE EXPLANATION OF PURPOSE OF CONSENT, VOLUNTARY NATURE OF RESEARCH, PURPOSE, DURATION, PROCEDURES OF THE RESEARCH, MAJOR FORESEEABLE RISKS TO THE SUBJECTS, BENEFITS TO THE SUBJECTS, AND ALTERNATE PRODUCTS OR PROCEDURES THAT MIGHT BENEFIT THE SUBJECT. THE PURPOSE OF THE NEW REQUIREMENT AS YOU KNOW IS TO MAKE SURE THAT POTENTIAL SUBJECTS RECEIVE AND COMPREHEND INFORMATION THAT WOULD HELP THEM MAKE IN A QUICK FASHION AND A WELL-INFORMED FASHION THE MAJOR RISKS AND BENEFITS, THE MAJOR REASONS WHY THEY WOULD DECIDE TO ENTER OR NOT ENTER THE STUDY. THIS IS THE PURPOSE OF CONCISE STATEMENT. BACKGROUND AS WE KNOW THAT THE INFORMED CONSENT FORMS HAVE BECOME SO LONG AND SO COMPLEX THAT IT IS DIFFICULT FOR SUBJECTS IN LOOKING AT A 20 OR 30 PAGE CONSENT FORM TO UNDERSTAND MAJOR FEATURES OF RISKS/BENEFITS. NANCY? >> ONE SMALL POINT OF CLARIFICATION, THAT LIST OF EXPLANATIONS IS IN THE PREAMBLE, NOT IN THE REGULATIONS. >> YOU ARE RIGHT, YES. YOU'RE RIGHT. IT'S IN THE COMMENTARY, NOT IN THE REGULATIONS. THE REVISED CONSENT REQUIREMENTS ALSO INCLUDE FOUR PARTICULAR STATEMENTS THAT MUST BE MADE IN THE CONSENT FORM IN ORDER TO COMPLY WITH THE REVISED COMMON RULE REQUIREMENTS. A STATEMENT IS REQUIRED THAT DATA SHED OF IDENTIFIERS MAY BE USED FOR FUTURE STUDIES WITHOUT A NEW INFORMED CONSENT, OR NOT, AS THE RESEARCHER AND INSTITUTION OFFERING THE INFORMED CONSENT MAY CONTEND BUT MUST BE SAID WHETHER THIS WILL HAPPEN OR NOT. A STATEMENT THE SUBJECT'S BIOSPECIMENS MAY BE USED FOR PROFIT, WHETHER THE SUBJECT WILL SHARE IN THE PROFIT OR NOT. THAT MUST BE SAID, EXPRESSED IN THE INFORMED CONSENT. A STATEMENT AS TO WHETHER THE RELEVANT RESEARCH RESULTS WILL BE DISCLOSED TO SUBJECTS OR NOT, AND FINALLY A STATEMENT AS TO WHETHER WHOLE GENOME SEQUENCING IS GOING TO BE PART OF THE RESEARCH OR NOT. THIS LAST REQUIREMENT IS ALSO IMPORTANT TO INTERPRET IN TERMS OF THE VARIOUS STATE LAWS THAT APPLY TO GENETIC TESTING AND GENOME SEQUENCING BECAUSE EVEN WITHOUT THIS, JUST AS A FOOTNOTE, EVEN WITHOUT THE NEW SPECIFIED INFORMED CONSENT REQUIREMENT IF ONE WANTS TO PERFORM WHOLE GENOME SEQUENCING OR OTHER GENETIC TESTING LAWS IN 30 STATES REQUIRE EXPLICIT INFORMED CONSENT UNLESS THERE IS THE BIOSPECIMEN THAT'S USED IS COMPLETELY SHED OF IDENTIFIERS AND ANONYMIZED, AND THERE ARE DIFFERENT STATE LAWS INTERPRET THIS, PROVIDE DIFFERENT ANONYMIZED RESEARCH EXCEPTIONS BUT IN GENERAL THIS STATEMENT IS ACTUALLY ASSISTING US BECAUSE IN MANY CASES OUR INFORMED CONSENT FORMS AS YOU KNOW IN THE PAST EVEN WHEN WHOLE GENOME SEQUENCING OR OTHER TESTING IS DONE HAVE NOT IN MY EXPERIENCE AT LEAST ADEQUATELY IMPLEMENTED STATE LAW REQUIREMENTS IN REGARD TO TELLING PEOPLE AND DISCLOSING TO PEOPLE WHAT MIGHT BE DONE IN THAT REGARD. WHEN ONE LOOKS AT THE FDA REGULATIONS ON INFORMED CONSENT, THERE ARE CLINICAL STUDIES THAT FALL UNDER THE COMMON RECALL BECAUSE THEY ARE FEDERALLY FUNDED, THERE ARE CLINICAL STUDIES THAT FALL UNDER FDA JURISDICTION, BECAUSE THEY ARE ABOUT DRUGS AND DEVICES THAT ARE IN INTERSTATE COMMERCE, AND THERE ARE STUDIES THAT FALL UNDER BOTH BECAUSE THEY COULD BE NIH-FUNDED STUDIES THAT ARE UNDER, FOR EXAMPLE, AN IND OR IDE AND WOULD HAVE COMPLY WITH ALL THESE REQUIREMENTS. THE FDA HAS NOT YET ADOPTED THE ON REVISIONS TO ITS INFORMED CONSENT RULES, REGULATIONS, THAT WOULD -- THAT CAME AFTER THE ADOPTION OF THE FINAL RULE, WITH ONE EXCEPTION, WHICH IS THAT THE FDA HAS ISSUED INTERPRETIVE GUIDANCE TO ALLOW WAIVER OF INFORMED CONSENT IN CERTAIN CIRCUMSTANCES THAT'S COME MORE RECENTLY. THE QUESTION IS, FOR STUDIES THAT ARE UNDER FDA JURISDICTION, BUT NOT UNDER COMMON RULE JURISDICTION, OR FOR STUDIES UNDER FDA JURISDICTION AND COMMON RULE JURISDICTION, SINCE THE FDA HAS NOT MIRRORED AND MAY NEVER MIRROR THESE REQUIREMENTS THEN WHAT DOES ONE DO IN THAT SITUATION? WE KNOW FDA REGULATIONS THAT EXIST NOW MIRROR ESSENTIALLY THE OLD COMMON RULE REQUIREMENTS AND THEY HAVE THE STANDARD KINDS OF PROVISIONS THAT WE'RE ACCUSTOMED TO IN THE OLD COMMON RULE REQUIRING THE ICF TO HAVE A STATEMENT OF PURPOSE, RISKS AND BENEFITS, OTHER INFORMATION BUT THE FDA REGS DO NOT AS OF TODAY REQUIRE THIS CONCISE STATEMENT, NOR DO THEY REQUIRE ALL OF THOSE FOUR SPECIFIC STATEMENTS REQUIRED UNDER THE NEW -- UNDER REVISED COMMON RULE. SO WHAT ABOUT HARMONIZATION HERE? THE 21ST CENTURY CURES ACT CALLS FOR HHS TO TAKE ACTION TO HARMONIZE THE HHS HUMAN SUBJECTS REGULATIONS AND ANALOGOUS FDA PROVISIONS, ALTHOUGH THE 21ST CENTURY CURES ACT WAS PASSED BEFORE THE FINALIZATION OF THE COMMON RULE, THE REVISED COMMON RULE. THE ACT ALSO REQUIRES A PROGRESS REPORT BE SUBMITTED TO CONGRESS NOT LATER THAN DECEMBER 13 OF 2018, AND HARMONIZATION BE COMPLETED BY DECEMBER 13 OF 2019. WE DON'T KNOW AND WE'RE NOT ASKING FDA TO OPINE, BUT IT WOULD NOT BE UNREASONABLE TO THINK THAT FDA IS LOOKING CAREFULLY AT THE EXPERIENCE OF THE IMPLEMENTATION OF THE REVISED COMMON RULE, TO UNDERSTAND WHETHER THE FDA THINKS THIS IS A GOOD THING OR WHETHER IT'S NOT NECESSARY FOR THE FDA TO MIRROR EXACTLY ALL OF THESE REQUIREMENTS, OR MAYBE FDA WOULD HAVE REQUIREMENTS OF ITS OWN THAT WOULD DIFFER FROM THESE BUT NOT BE INCONSISTENT WITH THAT THE REVISED COMMON RULE REGULATIONS. AND REMEMBER THAT IN TERMS OF THE ACADEMIC INSTITUTIONS, ACADEMIC TEACHING HOSPITALS, UNIVERSITIES, MEDICAL SCHOOLS, ET CETERA, EVEN WHEN THEY DO, WHEN THEY ARE A SITE TO CONDUCT FDA-REGULATED RESEARCH, EVEN IF THE FDA-REGULATED RESEARCH DOES NOT PER FORCE ALSO -- MUST NOT ALSO BE CONDUCTED UNDER THE REVISED COMMON RULE, NEVERTHELESS THESE ACADEMIC INSTITUTIONS MOST OFTEN TRY TO APPLY THE SAME STANDARDS TO ALL THE RESEARCH CONDUCTED THERE TO SIMPLIFY COMPLIACE PROCESS. AND SO WHEN THERE ARE FDA-REGULATED STUDIES CONDUCTED THERE, THESE ACADEMIC INSTITUTIONS MOST OFTEN TRY TO APPLY THE COMMON RULE REQUIREMENTS BECAUSE THEY APPLY THE COMMON RULE REQUIREMENTS TO ALL OF THEIR RESEARCH. RECENTLY, WITHIN THE LAST FEW DAYS, FDA HAS ISSUED A SHORT GUIDANCE DOCUMENT WHICH INDICATES THAT THE INFORMED CONSENT REQUIREMENTS OF THE REVISED COMMON RULE WHILE NOT PERFECTLY MIRRORING THOSE OR VICE VERSA ARE NOT INCONSISTENT WITH THE FDA REGULATIONS, SO IT IS ENTIRELY POSSIBLE TO HAVE AN INFORMED CONSENT FORM THAT ABSOLUTELY COMPLIES WITH BOTH SETS OF REQUIREMENTS. THAT OUGHT NOT BE A PROBLEM. AND SO SIMULTANEOUS COMPLIANCE RIGHT NOW IS COMPLETELY POSSIBLE AND WILL BE POSSIBLE AFTER THE COMPLIANCE DATE. AND IN TERMS OF THE RECOMMENDATIONS THESE ARE THE RECOMMENDATIONS AND WE'LL MOVE TO THE PANEL. SACHRP-- DRAFT RECOMMENDATIONS -- OHRP SHOULD ISSUE GUIDANCE CALLING FOR USE OF OLD COMMON RULE REQUIREMENTS FOR ALL RESEARCH UNTIL JANUARY 21 OF 2019 UNLESS THERE IS SOME COMPELLING REASON IN INDIVIDUAL CASE FOR THE STUDY TO BE TRANSITIONED. OHRP SHOULD ISSUE ADDITIONAL GUIDANCE IN REGARD TO CONSENT, WAIVERS, NEED TO OBTAIN NEW CONSENT. WE'VE GONE THROUGH SPECIFIC RECOMMENDATIONS ABOUT THAT. ULTIMATELY, DEPENDING ON WHAT FDA CHOOSES TO DO, THERE NEEDS TO BE GUIDANCE THAT WOULD INDICATE IF THE FDA REGULATIONS DO ANYTHING OTHER THAN MIRROR CHANGES TO THE COMMON RULE, THERE NEEDS TO BE A PATH BY WHICH -- A CLEAR PATH BY WHICH INSTITUTIONS, RESEARCHERS AND COMPANIES CAN ISSUE AND WRITE CONSENT FORMS AND UNDERTAKE RESEARCH THAT IS COMPLETELY CONSISTENT AND COMPLIANT WITH BOTH SETS OF REGULATIONS. TO THE EXTENT GUIDANCE IS NEEDED GUIDANCE SHOULD BE ISSUED IN THAT REGARD. OKAY. SO, THAT'S THE BACKGROUND. AND SO NOW I THINK LET'S TURN IT OVER TO THE PANEL. SO -- >> MARK, COULD I MAKE A COMMENT? >> YES, ABSOLUTELY. >> CHAIR'S PREROGATIVE. I JUST WANT TO FRAME THE NIGHTMARE HERE, INSTITUTIONS WANT TO KEEP THINGS -- EVERYBODY WANTS TO DO THINGS SIMPLY BUT WE ALL IN THE ABSENCE OF GUIDANCE AND PRECEDENT AND EXPERIENCE WITH THE NEW REQUIREMENTS, WE DON'T KNOW WHAT THAT MEANS. AND WE'RE ALL GOING TO COME UP WITH DIFFERENT IDEAS. AND SITTING AT AN IRB THAT DOES MANY MULTI-SITE TRIALS, THE IDEA THAT WE WILL NOW RECEIVE CONSENT FORMS EACH OF WHICH CONTAINS A DIFFERENT INSTITUTION OR SPONSOR'S VISION OF HOW TO INTERPRET THESE RULES, TAKES THE PROBLEMS THAT EXIST WITH MULTI-SITE RESEARCH AND CONSENT FORMS AND REALLY INCREASES THEM DRAMATICALLY. SO THAT REALLY IS MY -- WE NEED CLARITY BUT I THINK WE'LL GET TO THIS. WE ALSO NEED PERHAPS SOME PATIENCE AND FORBEARANCE FROM THE COMMUNITY AS A WHOLE. AND THE ONLY OTHER THING I WOULD SAY, MARK, YOU HAD A SLIDE, NANCY MENTIONED THOSE PROVISIONS WERE IN THE PREAMBLE, SO YOUR SLIDE SAID "MUST," THOSE ARE SUGGESTED. >> YES, THAT'S CORRECT. SORRY ABOUT THAT, YOU'RE RIGHT. >> THANKS. SORRY. >> NO, THAT'S FINE. OKAY. SO SHALL WE GO -- MEGAN, DO YOU WANT TO GO FIRST, IS THAT OKAY? >> THANK YOU FOR THE OPPORTUNITY TO BE HERE THIS MORNING AND THANK YOU TO SACHRP FOR TAKING ON THIS CHALLENGE OF GENERATING GUIDANCE FOR ALL OF US IN THE REGULATED COMMUNITY THAT ARE WORKING TO DEAL WITH THE TRANSITION. I THINK THERE'S A FEW THINGS THAT STUCK OUT TO ME PERSONALLY WITH THE PROVISIONS THAT ARE SET FORTH IN THE GUIDANCE, IN ITS DRAFT FORM, THAT I WANTED TO ASK THAT WE SPEND SOME TIME THINKING ABOUT OVER OUR NEXT FEW HOURS TOGETHER. SO, ONE IS IN THE AREA OF POTENTIAL FLEXIBILITY. ONE CHALLENGE THAT ISN'T CURRENTLY CONTEMPLATED IN THE GUIDANCE BUT IS A REAL LIMITATION FOR SOME ORGANIZATIONS IS THE FACT THAT IN ADDITION TO INSTITUTIONAL PRACTICE, TO APPLY THE COMMON RULE REQUIREMENT TO ALL RESEARCH, THERE' ALSO SOME STATE LAWS THAT REQUIRE THE APPLICATION OF FEDERAL REGULATIONS FOR HUMAN SUBJECTS PROTECTIONS TO ALL RESEARCH. THAT PUTS THOSE INSTITUTIONS IN A PARTICULARLY CHALLENGING POSITION TO HAVE TO ACCOMMODATE THE TRANSITION IN A BROADER WAY. AND CONSIDER THE IMPLICATIONS OF THAT, SPECIFICALLY IN AREAS WHERE THERE MAY BE CONFLICT. SO THAT'S ONE THING WE WOULD LIKE THE GUIDANCE TO ADDRESS, AND TO SPEND SOME TIME THINKING ABOUT, BECAUSE ALTHOUGH WE MAY ALL WANT TO BE ABLE TO ADOPT A MORE FLEXIBLE APPROACH, THERE CERTAINLY ARE SOME OF US WHO ARE MORE RESTRICTED IN THE CAPABILITY TO DO SO. ONE OTHER ITEM, AND I'M GLAD THAT STEPHEN RAISED THIS, IS AN ISSUE RELATED PARTICULARLY TO MULTI-SITE RESEARCH, AND ONE IN MY CAPACITY AT JOHNS HOPKINS, ONE OF THE ROLES THAT I SERVE IS COORDINATING THE ACTIVITIES OF OUR ROLE AS SINGLE OR CENTRAL IRB. AND ONE OF OUR CONCERNS MOVING INTO THIS NEW DOMAIN IS THAT INSTITUTIONS ARE INDEED INCORPORATING THEIR INTERPRETATION OF THE REGULATION INTO POLICY. AND ONE OF THE AREAS WHERE COMMENTARY WOULD BE PARTICULARLY USEFUL IS WHEN THAT POLICY BECOMES CONSIDERED AS A REQUIREMENT FOR LOCAL CONTEXT, RIGHT? SO, AS WE SERVE AS A REVIEWING IRB, AND WE TRY AS MUCH AS POSSIBLE TO LIMIT THE VARIABILITY AND CONSENT FORM DEVELOPMENT FROM SITE TO SITE ON ONLY THAT LANGUAGE THAT WOULD BE EITHER REQUIRED BY LOCAL STATE LAW OR REQUIRED AS A MATTER OF INSTITUTIONAL POLICY. AS INSTITUTIONS CERTAINLY EVOLVE TO INCORPORATE THE NEW REGULATORY REQUIREMENTS INTO POLICY, AND INTO INTERPRETATIONS OF WHAT THAT MIGHT MEAN, INCLUDING POLICIES SURROUNDING WHAT SPECIFIC WORDING MUST BE IN THE CONSENT FORM. THAT POSES VERY REAL CHALLENGES FOR THOSE WHO ARE SERVING IN THE CAPACITY OF A SINGLE IRB TO NOW HAVE TO ADDRESS THAT MANY RELIANCE SITES MAY HAVE VARIED POLICIES RELATED TO, FOR EXAMPLE, WHAT MAY CONSTITUTE KEY INFORMATION AND MAY CONSIDER THAT THAT POLICY ACTUALLY IS REPRESENTATIVE OF THEIR LOCAL CONTEXT. AND FOR THAT REASON, SHOULD BE INCORPORATED INTO THEIR VERSION OF THE MULTI-SITE CONSENT. THAT'S A REAL CHALLENGE THAT I HOPE THAT WE WOULD BE ABLE TO ADDRESS AS PART OF OUR DISCUSSION THIS MORNING AS WELL. THE LAST THING I WILL COMMENT ON THAT I THINK IS -- I APPRECIATE THERE WAS ATTENTION GIVEN TO THIS ISSUE. [ NO AUDIO ] [ PLEASE STAND BY ] >> ABSOLUTELY. SO ONE OF THE THINGS THAT IS AMBIGUOUS ABOUT THE WORDING OF THE LAW IS THAT IT READS, AND I BROUGHT IT FOR THIS EXPLICIT PURPOSE BECAUSE I KNEW MY COLLEAGUES IN MARYLAND AND ALSO IN NEW YORK HAVE SIMILAR CHALLENGES, IS THAT A PERSON MAY NOT CONDUCT RESEARCH USING A HUMAN SUBJECT UNLESS THE PERSON CONDUCTS THE RESEARCH IN ACCORDANCE WITH THE FEDERAL REGULATIONS ON THE PROTECTION OF HUMAN SUBJECTS. THE WAY THAT BROADLY HAS BEEN INTERPRETED AND HAS BEEN IMPLEMENTED IS THAT YOU VIRTUALLY HAVE TO EXTEND THE COMMON RULE REQUIREMENTS TO ALL RESEARCH. WHAT THAT WOULD MEAN IS A PARTICULAR AREA OF CHALLENGE IF THERE WERE A DISPUTE OVER CONSENT FORM DEVELOPMENT FOR A STUDY THAT WAS IN FACT CONDUCTED IN MARYLAND BUT FDA REGULATED AND NOT OTHERWISE SUBJECT TO THE COMMON RULE REQUIREMENTS. >> DO YOU THINK -- IS THERE A PROBLEM WITH INTERPRETING -- I UNDERSTAND WHAT YOU JUST SAID BUT IS THERE ALSO A PROBLEM IN UNDERSTANDING WHETHER THAT LAW WHICH REQUIRES ADHERENCE TO THE COMMON RULE REQUIREMENTS IN ALL RESEARCH ESSENTIALLY WHETHER THAT MEANS RIGHT NOW OR AFTER THE TRANSITION DATE THAT ALL RESEARCH MUST COMPLY WITH THE REVISED COMMON RULE, IS THAT AN AREA OF AM BIG AMBIGUITY? >> NOT AS MUCH BECAUSE THERE'S SPECIFIC PROVISIONS IN THE RULE THAT OUTLINE HOW YOU MAY OR MAY NOT TRANSITION. >> RIGHT, OKAY. >> WE WEREN'T WORRIED THAT -- BECAUSE OF THE FACT THERE IS A NEW RULE WE SUDDENLY HAVE TO TRANSITION ALL RESEARCH TO THAT RULE. THE RULE ALLOWS FOR YOU SPECIFICALLY NOT TO DO SO. WE DIDN'T HAVE THE SAME CONCERN. >> OKAY. GREAT. HEATHER? >> THANK YOU, MARK AND THANK YOU FOR HAVING ME HERE TODAY TO BE PART OF THIS CONVERSATION FOR THOSE WHO ARE NOT FAMILIAR, THE ASSOCIATION OF AMERICAN MEDICAL COLLEGES, IS A NON-PROFIT ASSOCIATION WHOSE MEMBERS INCLUDE ALL ACCREDITED MEDICAL SCHOOLS IN THE U.S. AND CANADA, AND OVER 400 TEACHING HOSPITALS AND HEALTH SYSTEMS INCLUDING THE V.A. SYSTEM. THROUGH THESE INSTITUTIONAL MEMBERS, OUR CONSTITUENTS INCLUDE HUNDREDS OF THOUSANDS OF PHYSICIANS, RESEARCHER, BIOMEDICAL GRADUATE STUDENTS, AND THE LIKE. AND SO HAPPY TO BE HERE TO PROVIDE SOME OF THE NATIONAL PERSPECTIVE ON WHAT WE'RE SEEING ON THESE. I'D LIKE TO BRING UP ISSUES RELATED TO MANY OF THE PROPOSED RECOMMENDATIONS THAT ARE IN THIS DOCUMENT AND THEN DISCUSS THEM FURTHER AS IT MAKES SENSE. GENERALLY, VERY GLAD WE'RE HAVING CONVERSATION, ALL THE LACK OF GUIDANCE ESPECIALLY AROUND INFORMED CONSENT HAS BEEN A SERIOUS ISSUE OF CONCERN FOR ACADEMIC MEDICINE, IT'S BEEN FRUSTRATING FOR INSTITUTIONS TRYING TO CHANGE FORMS, POLICIES, SOFTWARE, EDUCATE RESEARCHERS AND RESEARCH STAFF, WHILE BEING AFRAID OF NOT DOING IT RIGHT AND HAVING TO REDO IT AFTER GUIDANCE COMES OUT. SO I'VE TALKED TO PEOPLE WHO FEEL LIKE THEY ARE IN THE DARK, THAT THEY ARE STRUGGLING AND SOMEONE RECENTLY SAID I FEEL LIKE OUR INSTITUTION IS SO FAR FROM BEING READY TO IMPLEMENT THE CHANGES BUT THAT AS SOON AS I UPDATE OUR TEMPLATES AND POLICIES THERE WILL BE A GUIDANCE DOCUMENT THAT SHOWS ME I HAVE TO START FROM SCRATCH AND MY INVESTIGATORS AND ADMINISTRATORS ARE ALREADY FRUSTRATED WITH ME ABOUT THIS. THIS IS VERY APPRECIATIVE SACHRP IS TAKING THIS ON. A FEW QUICK COMMENTS, ON THE WAIVER OF INFORMED CONSENT, I STRONGLY AGREE THERE SHOULD NOT BE A REQUIREMENT TO GO BACK AND GET AN ADDITIONAL WAIVER WITH ONE ADDITIONAL ELEMENT. WE DON'T SEE ANY PARTICULAR ADDITIONAL PROTECTION THAT THAT WOULD PROVIDE, BUT AN ADDITIONAL BURDEN WHICH IS NOT WHAT WAS INTENDED BY THE RULE. NOW, THIS SHOULD NOT BE PROHIBITED THOUGH. THERE SHOULD BE AN OPTION IF THE PARTICULAR TYPE OF RESEARCH OR SENSITIVITIES AROUND THE RESEARCH WOULD ENCOURAGE -- WOULD SUGGEST TO AN INSTITUTION THAT GOING BACK HAVING IT BE REREVIEWED BY AN IRB TO MAKE SURE THAT IT'S STILL SOLID WITH ADDITIONAL CRITERION SHOULD OF COURSE BE AN OPTION. THE IDEA OF CONSENT FORM TEMPLATES IS -- CONTINUES TO BE INTRIGUING AND POTENTIALLY HELPFUL. THIS IS AN EFFORT THAT HAS GONE ON FOR MANY, MANY YEARS, I KNOW MANY OF YOU IN THIS ROOM HAVE BEEN INVOLVED IN EFFORTS, YOU KNOW, IN 2007 THE AMC TOOK ON THIS ISSUE, IN 2015 THE CPTI TOOK ON THE ISSUE AND HAS COME UP WITH RECOMMENDATIONS, WITH TEMPLATES. THIS HAS COME A LONG WAY BUT IT'S OUR SENSE THAT THE STICKING POINTS THAT CONTINUE TO COME UP REMAIN CONSISTENT OVER THE YEARS AND ARE NOT SPECIFICALLY ADDRESSED IN THE REVISED COMMON RULE, SO THAT WHEN IT COMES TO ACTUAL ADOPTION AND IMPLEMENTATION OF INFORMED CONSENT TEMPLATES, WE GET INTO WHAT IS -- WHAT IS DESCRIBED IN THE DRAFT RECOMMENDATION OF THE BATTLE OF THE FORMS, WHERE WE CAN GET INSTITUTIONS ESPECIALLY MULTI-SITE TRIALS OR MULTI-INSTITUTION COLLABORATIONS CAN GET 75% OF THE WAY IN AGREEMENT BUT THEN THE NEGOTIATIONS ON THE SAME PROVISIONS, WHETHER INDEMNIFICATION OR SUBJECT INJURY OR ISSUES OF LOCAL CONTEXT THAT YOU BROUGHT UP REMAIN CONCERNING. THAT SAID, WE'RE STILL HOPEFUL THAT THIS COULD BE -- THIS COULD BE A NEW WAY OF APPROACHING AN INFORMED CONSENT TEMPLATE. WE THINK GIVEN THE CONVERSATION AROUND HARMONIZATION, GIVEN LAST WEEK'S BRIEF BUT HEARTENING GUIDANCE DOCUMENT FROM FDA THAT IT'S IMPERATIVE THAT FDA AND OHRP WORK TOGETHER TO CREATE TEMPLATES TO MAKE IT CLEAR THAT INFORMED CONSENT DOCUMENTS CAN SIMULTANEOUSLY MEET THE REQUIREMENTS OF BOTH SETS OF REGULATIONS, REGARDLESS OF HOW CLOSE THE FDA REGULATINS COME TO THE FINAL REVISED COMMON RULE. THE SPECIAL CONSIDERATIONS I THINK WE'LL DISCUSS I'M SURE LATER TODAY, FOR MULTI-SITE TRIALS, REALLY EXACERBATE ALL OF THE ISSUES WE'RE TALKING ABOUT TODAY, AND THE LACK OF HARMONIZATION ACROSS SITES IS AS POTENTIALLY DAMAGING OR BURDEN INCREASING AS LACK OF HARMONIZATION BETWEEN TWO SETS OF REGULATIONS AND WE SHOULD BE WORKING TOGETHER AS A COMMUNITY WITH GUIDANCE FROM THIS GROUP, FDA AND OHRP, TO MAKE THAT A REALITY. I'D LIKE TO TALK FOR A FEW MINUTES ABOUT THE ISSUE OF POSTING OF THE INFORMED CONSENT DOCUMENTS, AND I GO BACK AS MANY OF YOU HAVE TO THE PREAMBLE AND COMMENTARY ON THE PURPOSE OF THIS POSTING WHICH IS REALLY TO IMPROVE THE QUALITY OF CONSENT FORMS, TO ALLOW AN EVOLUTION AND UNDERSTANDING OVER TIME AND SO THAT REQUIRES NOT JUST THAT THEY ARE FINDABLE SOME WAY, BUT THAT THERE IS SOME -- THAT THERE IS SOME EFFORT AND SOME ABILITY TO BE ABLE TO SEE WHAT HAPPENS IN CONSENT DOCUMENTS OVER TIME, TO BE ABLE TO TRACE THIS PATH THROUGH. IT IS WORTH CONSIDERING THE VALUE IN THIS RUBRIC OF TRYING TO IMPROVE QUALITY, IT'S WORTH CONSIDERING WHAT IS THE VALUE OF POSTING INFORMED CONSENT DOCUMENTS THAT WERE DEVELOPED WITH A PRE-2018 REQUIREMENT. SO THIS IS A CONSIDERATION WITH THE DRAFT RECOMMENDATION THAT IF A STUDY TRANSITIONED TO THE NEW RULE, SO AN EXAMPLE OF A LONGITUDINAL STUDY PAST JANUARY OF 2019 BUT ENROLLED FINAL SUBJECT BEFORE THEIR TRANSITIONS TO THE REVISED REQUIREMENTS BUT THERE ARE NO EXISTING CONSENT FORMS THAT INCORPORATE THE REVISED REQUIREMENT. THEY WERE NEVER USED, NEVER REQUIRED TO BE USED. MY CONCERN IS THAT REQUIRING TO POSTING OF THOSE CONSENT FORMS THAT ARE NO LONGER COMPLIANT WITH THE NEW REQUIREMENTS SUGGEST THAT SOMEONE HAS DONE SOMETHING WRONG AND DOESN'T ACTUALLY HELP TO MOVE THINGS FORWARD BECAUSE IT'S AN EXAMPLE OF A FORM WE'VE GONE AWAY FROM. SO I MIGHT SUGGEST A CHANGE THERE. OR ALTERNATIVELY A SPECIFIC DESIGNATION ON THE FORM OR IN A CHECK BOX OR SOMETHING THAT WHAT WE'RE POSTING IS A PRE-2018 REQUIREMENT RULE. ONE PIECE THAT I THINK IS WORTH CONSIDERING BY THIS GROUP IS THAT GIVEN THAT WE ARE HOPEFUL THIS WILL BE AN EVOLUTION, WE'LL BE ABLE TO TRACE THIS OVER TIME, THE ORDER IN WHICH FORMS WILL BE POSTED AND DATE ON WHICH THEY ARE POSTED WILL NOT IN ANY WAY REFLECT THE DATE IN WHICH THEY WERE DEVELOPED. THAT WILL BE MORE A REFLECTION OF THE LENGTH OF TIME OF THE STUDY THAN OF THE WHAT WENT BEFORE. AND SO HAVING SOME WAY TO HELP BETTER UNDERSTAND WHEN THE FORM WAS DEVELOPED, WHEN IT WAS LAST USED WITH A SUBJECT, WILL BE I THINK IMPORTANT IF WE'RE GOING TO REALLY TRY TO FIND SOME SORT OF SYSTEMATIC WAY OF LOOKING BACKWARDS, AT FORMS. I APPRECIATE THE DISCUSSION ABOUT clinicaltrials.gov AND THE REGULATIONSGOV DOCKET. WHILE I AGREE THAT THAT WOULD NOT AUTOMATICALLY TRYINGER RESULTS REPORTING, YOU CAN'T REALLY PUT AN INFORMED CONSENT DOCUMENT INTO clinicaltrials.gov IN A VACUUM, AND SO IN TERMS OF FIGURING OUT WHAT ARE THE MINIMUM NUMBER OF FIELDS YOU COULD PUT IN TO GIVE IT ANY CONTEXT AT ALL IS WORTH CONSIDERING, AND IN REGULATIONS.GOV WOULD THERE BE ADDITIONAL CONTEXT OF WHAT IS THIS TRIAL, WHERE DID IT TAKE PLACE OR JUST RELY ON THE WORDS IN THE ACTUAL DOCUMENT. SO I THINK FINALLY TALKING ABOUT THE HARMONIZATION WITH FDA, ABSOLUTELY IMPERATIVE, THE VERY WELL-TIMED GUIDANCE DOCUMENT ON FRIDAY SUPPORTS THE ASSERTION IN THE DRAFT RECOMMENDATION THAT THE ADDITIONAL REQUIREMENTS ARE NOT INCONSISTENT AND WOULDN'T NEED TO CREATE TWO DIFFERENT FORMS. IT'S HEARTENING TO SEE EVIDENCE OF THIS MOVEMENT TOWARDS HARMONIZATION AND I STRONGLY AGREE THAT THE DECEMBER -- AND FOR THOSE IN FDA THAT ARE LISTENING, THE DECEMBER 2018 REPORT TO CONGRESS WILL BE AN IMPORTANT STEP NOT JUST FOR CONGRESS TO HEAR BUT FOR THE ENTIRE RESEARCH COMMUNITY TO BE -- TO HAVE CONFIDENCE THAT THE GOALS OF HARMONIZATION ARE REALLY BEING REALIZED. THE RECOMMENDATION FOR GUIDANCE THAT STUDIES SHOULD REMAIN UNDER THE 2018 ABSENT COMPELLING REASONS, I THINK THAT MAKES PRACTICAL SENSE. WITH THAT SHOULD BE SOME EXAMPLES OF WHAT THOSE COMPELLING REASONS MIGHT BE. IT WOULD BE HELPFUL FOR SACHRP TO THINK ABOUT AND FOR OHRP TO DISSEMINATE A SET OF CONSIDERATIONS THAT WOULD HELP NOT JUST IN THAT LIMITED CASE BUT GENERALLY WHY MIGHT AN INSTITUTION WANT TO TRANSITION A PRE-2018 -- OR A STUDY INITIATED BEFORE JANUARY 21, 2019, WHY MIGHT ONE WANT TO TRANSITION A STUDY AND WHY WOULDN'T THE OTHER PARTICULAR CRITERIA, PARTICULAR SENSITIVITIES OR PARTS -- STAGES OF THE TRIAL OF THE RESEARCH LIFE CYCLE THAT WOULD MAKE IT MORE COMPELLING. AND SO THOSE I THINK I'LL LEAVE THERE, HAPPY TO ANSWER ANY QUESTIONS, AND LOOK FORWARD TO THE CONTINUATION OF THE DISCUSSION. >> HEATHER, LET ME ASK YOU ONE QUESTION ABOUT THE LAST THING THAT YOU SAID. IF WE'RE GOING TO PUT IN SOME EXAMPLES OF STUDIES FOR WHICH THERE ARE COMPELLING REASONS LIKE NOW IS THE TIME TO DO IT BECAUSE IF WE ONLY SAY THAT -- IF WE ONLY RECOMMEND TO OHRP THEY DO IT, IT PROBABLY WON'T BE DONE IN TIME, SO IF WE'RE GOING TO PUT SOMETHING IF LET'S PUT IT IN NOW AND SO I'M JUST WONDERING, YOU DON'T HAVE TO ANSWER THIS, BUT THIS IS FOR THE LATER DISCUSSION WITH THE SACHRP, CAN ANYONE THINK OF A SITUATION IN WHICH TRANSITION REALLY THERE IS A COMPELLING REASON TO TRANSITION STUDIES THAT DON'T NEED TO BE TRANSITIONED. I COULDN'T THINK OF ONE BUT THAT DOESN'T MEAN IT DOESN'T EXIST. >> SO OFFHAND I WOULD -- I THINK THERE MAY BE CIRCUMSTANCES IN WHICH THE NATURE OF THE RESEARCH IS SO -- HAS POTENTIAL CONCERNS ABOUT VULNERABILITY OF SUBJECTS ABOUT ISSUES THAT ARE PARTICULARLY IN THE PUBLIC EYE, MAYBE RESEARCH THAT MAY BE CONTROVERSIAL, WHERE IT IS -- THERE'S A COMPELLING REASON TO BE ABLE TO PUBLICLY DEMONSTRATE THAT EVERY AVENUE WE HAVE TO ENSURE THE PROTECTION OF HUMAN SUBJECTS, INCLUDING INCORPORATING ALL THE NEW REQUIREMENTS OF THE NEW RULE MAY BE HELPFUL FROM A CROSSING Ts AND DOTTING Is PERSPECTIVE. THAT MAY NOT BE A SACHRP RECOMMENDATION BUT I WOULDN'T WANT IT TO STAY OUT THERE THAT THERE'S PROBABLY NEVER A REASON THAT YOU WANT TO TRANSITION. I DO AGREE THAT IN MOST CASES IT MAKES SENSE TO STAY UNDER THE OLDER COMMON RULE UNTIL COMPELLED TO DO SO. >> REMEMBER ALSO THAT THIS WAS ONE OF THE COMMENTS MADE IN SOME OF THE DRAFTING OF THE DRAFT GUIDANCE DOCUMENT THAT WE HAVE, AND THAT IS THAT JUST BECAUSE A STUDY HAS NOT TRANSITIONED DOES NOT MEAN IT CANNOT VOLUNTARILY SAY THINGS LIKE WHETHER BIOSPECIMENS WE USED IN THE FUTURE, DOESN'T MEAN IT CAN'T HAVE A CONCISE STATEMENT, IN OTHER WORDS ONE CAN HAVE VOLUNTARY COMPLIANCE WITH CERTAIN ELEMENTS OF THE REVISED COMMON RULE WITHOUT ACTUALLY TRANSITIONING TO THE COMMON RULE. STEPHEN? >> THERE WAS AN E-MAIL THREAD LAST NIGHT. I WANT TO BE CLEAR MY UNDERSTANDING, IF I'M WRONG I'LL INVITE OHRP TO CONTRADICT ME, IF I'M RIGHT YOU DON'T HAVE TO SAYING ANYTHING THAT VOLUNTARY COMPLIANCE WITH ASPECTS OF THE RULE ISN'T TRANSITION. FOR IT TO BE TRANSITION.SITION- YOU CAN DO ANY PIECE WITHOUT FEAR OF THAT. >> RIGHT >> THE OTHER THING, HEATHER, I WANT TO COMMENT ON IS TEMPLATES. I INVITE ALL OF YOU IF YOU HAVE TIME TO STAY FORT FOR THE REST OF THE MEETING DISCUSSING OUR RECOMMENDATIONS AND KEY ELEMENTS OF CONSENT, THE CONCISE SUMMARY, THAT WE'VE BEEN WORKING ON IT FOR A LONG TIME. WE'VE GONE THROUGH A BUNCH OF EXERCISES, REALLY TO TRY TO GET AT WHETHER IN FACT THAT COULD BE TEMPLATED. AND WE FAILED EVERY TIME WE TRIED. SO I THINK THERE ARE ASPECTS OF THE NEW RULE THAT REALLY ALMOST BY DESIGN AND I THINK SORT OF FROM A HUMANITARIAN PHILOSOPHIC POINT OF VIEW AND INTERPERSONAL THING THEY ARE RIGHT, CONSENT WILL BE MORE EFFECTIVE WHEN IT'S LESS TEMPLATED, MORE SUITED TO THE INDIVIDUAL RESEARCH AND CIRCUMSTANCE. I'M NOT ARGUING THAT'S PRACTICAL BUT I DO THINK THERE ARE PARTICULAR CHALLENGES TO A TEMPLATE APPROACH WITH KEY INFORMATION AND JUST NEED TO BE AWARE. THEY JUST MAKE THE PROBLEMS WORSE. >> YES, I AGREE AND RECOGNIZE NOT ONLY THE DIFFICULTY IN COMING TO SOME SORT OF CONSENSUS BUT THAT MAY NOT BE AN IDEAL PIECE. WHAT WOULD I THINK BE HELPFUL AND HELP INSTITUTIONS FEEL FREER TO ADAPT THAT KEY INFORMATION IN WAYS THAT ARE MEANINGFUL IS TO BE VERY, VERY CLEAR ABOUT WHICH PARTS, WHICH REQUIREMENTS CAN BE TEMPLATED, WHICH ONES COULD WE COME TO CONSENSUS ON, SOMETIMES WE REFER TO AS THE OPEN AND CLOSED SECTIONS OF AN INFORMED CONSENT DOCUMENT, MULTI-SITE STUDY TO SAY -- TO GIVE INSTITUTIONS THE FREEDOM TO SAY THIS IS AS MUCH GUIDANCE AS YOU'RE GOING TO GET AND THAT'S OKAY, WE EXPECT THERE TO BE VARIATION BECAUSE THE REAL FEAR IS DOING IT WRONG. >> OKAY. THANK YOU FOR HAVING US HERE TODAY. I THINK THE ENTIRE PANEL WILL HELP PROVIDE ADDITIONAL INSIGHT INTO TRANSITION INSIGHT. BEFORE I JUMP INTO MY BRIEF OPENING COMMENTS I WANT TO GIVE BACKGROUND IN TERMS OF WHO I'M REPRESENTING HERE TODAY, WHERE MY PERSPECTIVE AND COMMENTS ARE GOING TO BE FOCUSED. I'M REPRESENTING JOHNSON AND JOHNSON, A GLOBAL PHARMACEUTICAL MEDICAL DEVICE AND PRODUCT COMPANY, FOCUSED ON MEDICAL DEVICE AND MEDICAL DEVICE INDUSTRY AS A WHOLE. I'M SURE THERE'S OVERLAP BETWEEN PHARMACEUTICAL COMPANIES ALSO REPRESENTED UP HERE, BUT I THINK THERE ARE SOME UNIQUE ISSUES BOTH AROUND THE MEDICAL DEVICE INDUSTRY AND THE WAY MEDICAL DEVICE STUDIES ARE TRADITIONALLY UNDERTAKEN THAT I WANT TO SHED LIGHT ON WE'LL BE ADDING INTO THE DISCUSSION TODAY. THE FIRST OF THOSE ISSUES IS SORT OF THE MAKEUP OF THE MEDICAL DEVICE INDUSTRY AS A WHOLE. WHILE JOHNSON AND JOHNSON IS LARGE AND SOPHISTICATED ORGANIZATION, THAT'S NOT NECESSARILY THE CASE OF THE ENTIRE MEDICAL DEVICE INDUSTRY AS A WHOLE. I DON'T KNOW THE EXACT DETAILS OR EXACT NUMBERS, BUT I THINK IT'S SOMEWHERE IN THE ORDER OF MAGNITUDE 60% OF THE MEDICAL DEVICE INDUSTRY IS MADE UP OF ORGANIZATIONS OF 50 INDIVIDUALS OR LESS, WITH MUCH SMALLER SALES THAN AVERAGE PHARMACEUTICAL COMPANY. SO WHEN YOU THINK ABOUT THAT AND LEVEL OF SOPHISTICATION ASSOCIATED WITH MANY OF THOSE ORGANIZATIONS, THEY MAY BE UNDERTAKING ONE, MAYBE TWO CLINICAL TRIALS, OVER THE COURSE OF THE ENTIRE EXISTENCE OF THAT COMPANY. SO THESE ARE NOT ORGANIZATIONS THAT HAVE DEDICATED CLINICAL TRIAL ORGANIZATIONS NECESSARILY IN SOME INSTANCES, THEY ARE OUTSOURCING THE DESIGN AND OVERSIGHT OF THESE CLINICAL TRIALS THEMSELVES, WHICH HONESTLY IS HELPFUL BECAUSE THOSE ORGANIZATIONS ARE MORE SOPHISTICATED, DO THIS ON A REGULAR BASIS, BUT THAT'S NOT NECESSARILY THE CASE FOR ALL THESE COMPANIES. MY FIRST COMMENT WOULD BE THE COMMON RULE AND SORT OF PARTICULARLY OVERLAP OF FDA JURISDICTION, COMMON RULE JURISDICTION, OR CLINICAL TRIALS IS RELATIVELY COMPLICATED FOR UNSOPHISTICATED ORGANIZATIONS AND ORGANIZATIONS AND INDIVIDUALS THAT HAVEN'T GONE THROUGH THIS AND DON'T DO THIS ON A REGULAR BASIS. I BELIEVE THERE IS A NEED FOR GUIDANCE AND INFORMATION AROUND HOW -- WHEREVER THE RECOMMENDATIONS OF THIS ORGANIZATION AND THE FINAL RULES AND -- NOT FINAL RULES BUT INTERPRETATION AND TRANSITION PERIODS, BIOLOGY THAT DOWN TO A LEVEL THAT'S UNDERSTANDABLE TO -- BOILING THAT DOWN TO A LEVEL THAT'S UNDERSTANDABLE NOT JUST TO THE ORGANIZATIONS ON THE PANEL BUT FOR INDIVIDUALS AND ORGANIZATIONS THAT AREN'T ACTIVELY FOLLOWING THIS, HAVE NOT BEEN FOLLOWING THIS FOR THE LAST EIGHT YEARS, AND THAT MIGHT BE THINKING ABOUT THIS FOR THE FIRST TIME WHEN THEY SUBMIT THEIR DOCUMENTATION TO AN IRB. I'D ALSO HIGHLIGHT IN THE MEDICAL DEVICE COMMUNITY, THIS IS TRUE IN PHARMA AS WELL, IT'S NOT JUST SPONSOR INITIATE AND SPONSOR OVERSEEN CLINICAL TRIALS THAT WE'RE TALKING ABOUT. A LOT OF THE RESEARCH DONE IN THE MEDICAL DEVICE INDUSTRY ALSO STEMS FROM INVESTIGATOR INITIATED RESEARCH, THAT MIGHT NOT NECESSARILY BE TAKING PLACE, NOT NECESSARILY MULTI-SITE, NOT NECESSARILY BEING DONE BY THE ACADEMIC AND MEDICAL INSTITUTIONS THAT ARE REPPING BEING REPRESENTED IN THE DISCUSSIONS HERE TODAY. THERE'S LOCAL AND REGIONAL HOSPITALS AND ACADEMIC INSTITUTIONS THAT MIGHT NOT BE DOING FEDERALLY FUNDED RESEARCH THAT IS WITHIN THE FULL ON-PAPER SCOPE OF THE COMMON RULE. SO THE AREA OF -- THE DELTA BETWEEN FDA REGULATED RESEARCH AND COMMON RULE REGULATED RESEARCH MIGHT BE LARGER IN THE DEVICE COMMUNITY THAN IN OTHER AREAS OF THE RESEARCH COMMUNITY. I THINK IT'S WORTH AT LEAST IDENTIFYING THAT IF FDA CHOOSES NOT TO MIRROR THE COMMON RULE REQUIREMENTS, FURTHER œOF WHAT IT MEANS TO BE COMPLIANT WITH THE FDA REQUIREMENTS IN ORGANIZATIONS AND INSTITUTIONS THAT MIGHT NOT BE SUBJECT TO THE COMMON RULE REQUIREMENTS UNDERSTANDING, BEING CLEAR ON THAT AND UNDERSTANDING THAT THERE ARE SITUATIONS WHERE THAT MIGHT BE APPROPRIATE, PARTICULARLY WHEN I GO BACK SORT OF TO THE INSTITUTION SETTING, I THINK THERE WAS A SLIDE, AROUND SLIDE 18, FINAL BULLET WAS ALTHOUGH THE COMMON RULE DOES NOT APPLY TO FDA REGULATIONED RESEARCH MANY APPLY TO ALL RESEARCH CONDUCTS THERE, THAT STATEMENT IS NOT 100% TRUE ACROSS THE BOARD. TO THE EXTENT THAT MAY CONTINUE TO BE TRUE IN SOME INSTITUTIONS, WE SHOULD RECOGNIZE THAT AND MAKE SURE BOTH, AND CLARIFYING IN THAT SCENARIO WHAT REQUIREMENTS APPLY AND I BELIEVE IN RECOMMENDATIONS THAT MARK PUT FORWARD SORT OF CLARIFYING THAT INSTITUTIONS AND RESEARCH ITSELF SHOULD BE VERY CLEAR IN WHAT REQUIREMENTS AND WHAT REGULATIONS APPLY TO THAT PARTICULAR STUDY. I THINK IN THE VAST MAJORITY WE'LL BE LOOKING AT DUAL OVERSIGHT, BUT THAT'S NOT NECESSARILY THE CASE FOR EVERYTHING. AND UNDERSTANDING THAT AND MAKING SURE THAT'S UNDERSTOOD BY THE INDIVIDUALS AND ORGANIZATIONS RESPONSIBLE FOR OVERSEEING THAT RESEARCH I THINK IS GOING TO BE VERY IMPORTANT. FINALLY, I THINK THIS BOTH GOES WITHOUT SAYING AND EVERYTHING THAT I'VE SEEN AND HEARD THUS FAR INDICATES THIS, BUT TO THE EXTENT FDA IS PROMULGATING REVISIONS TO THE REGULATIONS, DOING THIS FORMAL NOTICE IN COMMON RULE MAKING WILL BE IMPORTANT. I THINK THE TWO OTHER OPTIONS THAT COULD POTENTIALLY BE ON THE TABLE, WHETHER MAKING THESE UPDATES AND POLICIES THROUGH GUIDANCE I THINK LACK THE FORCE OF LAW THAT WILL BE NECESSARY FOR HEALTH CARE INSTITUTIONS, RESEARCH INSTITUTIONS, TO ENFORCE IT I THINK IS PROBLEMATIC. AND DOING IT THROUGH DIRECT FINAL RULE MAKING, RULE MAKING THAT DOES NOT ALLOW FOR NOTICE AND COMMENT WOULD BE CHALLENGING AS WELL. I THINK ACROSS THE BOARD THERE'S GOING TO BE A LOT OF QUESTIONS AND INPUT THAT ARE GOING TO BE NECESSARY TO BE ADDED INTO THAT PROCESS, AND HEARING DIRECTLY FROM BOTH SPONSORS OF THIS TYPE OF RESEARCH, RESEARCH INVESTIGATORS, PATIENTS AS WELL WILL BE VALUABLE BOTH IN THE FDA SETTING AND IN THE COMMON RULE SETTING AND I WOULD ADVOCATE THAT CONTINUE TO MOVE FORWARD BUT AGAIN LIKE I SAID I THINK EVEN IN THE GUIDANCE DOCUMENT ON FRIDAY FDA INDICATED THAT AT THAT RULE MAKING WAS UNDERWAY SO WE'RE COMFORTED TO HEAR THAT. WITH THAT MAYBE I CAN PASS DOWN TO THE BOARD OR RESPOND TO ANY QUESTIONS. >> ANY IMMEDIATE QUESTIONS OR COMMENTS? OKAY. THANK YOU. THANK YOU, PHILIP. TIM? >> THANK YOU. SO I'M TIM CHULINDRA, ONE OF THE VICE PRESIDENTS, CHIEF PRIVACY OFFICER FOR PRA HEALTH SCIENCES, CONTRACT RESEARCH ORGANIZATION, GLOBAL PRESENCE, BASED OUT OF RALEIGH, NORTH CAROLINA, HELP COORDINATE CLINICAL TRIALS, I WANT TO MAKE SURE I WANT TO HAVE RESPONSIBLE COMMUNICATIONS HERE THAT MY LENS WILL BE SPECIFICALLY FROM A DATA PRIVACY PERSPECTIVE WHICH IS VERY SMALL LENS, AND THEN ALSO IT'S A HOT TOPIC AND I'LL STAY A POINT, EUROPEAN UNION, SOMETHING WE'RE LIVING EVERY DAY, LESSONS CAN BE LEARNED, ALSO EXPERIENCES THAT CAN BE SHARED. I'M ENCOURAGED TO HEAR THE RULES CAN POTENTIALLY COEXIST. I THINK EVEN ACKNOWLEDGING AND COMMUNICATING TO STAKEHOLDERS, I THINK ONE OF THE KEY PHRASES HERE THAT I THINK IS FEAR OF DOING IT WRONG, AND SO WITH OUR ORGANIZATION WE HELP FACILITATE CLINICAL TRIALS FOR A NUMBER OF STAKEHOLDERS WITH A VARIETY OF SOPHISTICATIONS, AND SO WHAT'S HELPFUL IS TO HAVE GUIDANCE, AND I THINK IT'S TEMPTING TO SAY LET'S HAVE A CHECKLIST. I THINK IT'S PERHAPS EVEN HAVING THINGS TO ACKNOWLEDGE THAT THIS IS A DIFFICULT TOPIC. HERE ARE SOME THINGS TO CONSIDER AS WE'RE GOING THROUGH THE EUROPEAN UNION GDPR, I THINK WHAT'S HELPFUL IS THERE'S NO RIGHT OR WRONG ANSWERS. I MEAN, I THINK YOU'RE DEALING WITH A LOT OF AMBIGUITY. IF WE CAN GIVE TOOLS AND RESOURCES TO A LOT OF THE STAKEHOLDERS TO GIVE THEM COMFORT, TO KNOW THAT THEY ARE NOT DOING THE WRONG THING, I THINK WE'RE GOING TO MISS. I MEAN, THAT'S JUST THE REALITY. EVEN ACKNOWLEDGMENT OF THAT WILL HELP. YOU KNOW, THE OTHER CHALLENGE, INTERPRETATION IS BIG SO IF THERE'S SOME I WOULD SAY CONTROVERSIAL OR HOT TOPICS I WOULD HIGHLY SUGGEST THAT THOSE BE HIGHLIGHTED IN A WAY THAT -- AS CRO, WE INTERACT WITH SPONSORS AND CAN'T GIVE LEGAL OR PRIVACY COMPLIANCE ADVICE BUT THEY STILL LOOK TO US FOR WE'RE A GLOBAL ORGANIZATION. AND SO ANY KIND OF DATA POINTS THAT WE CAN HAVE IN TERMS OF GUIDANCE DOCUMENTS, ESPECIALLY IF THERE'S ALIGNMENT BETWEEN THE FDA AND OHRP, WOULD BE VERY BENEFICIAL. AND I ALSO THINK THE OTHER THING THAT'S BEEN VERY HELPFUL AT LEAST WITH THE GDPR, I'VE ACTUALLY SEEN IT'S ONLY BEEN IMPLEMENTED IN MAY, BUT I THINK COLLECTIVELY, THIS IS COMMON SENSE, TO HEAR IT OUT LOUD IS I THINK THE GUIDANCE OF THE RECOMMENDATIONS TALKED ABOUT BATTLE OF THE FORMS, YOU NEED TO USE THIS FORM, USE THAT FORM. I'VE SEEN A SHIFT ACROSS THE BOARD IN TERMS OF PEOPLE TAKING A LOOK AND SAYING WE USED TO REALLY FIGHT HARD ON THIS PROVISION BUT IS IT LEGALLY REQUIRED? THE BEGINNING OF THAT DISCUSSION AND DIALOGUE, VIEWING IT AS A PARTNERSHIP, WE'RE ALL TRYING TO INTERPRET THIS TOGETHER. I'M ENCOURAGED BY THE TONE. I CAN TELL YOU THIS IS -- I WISH I WOULD HAVE HAD SOME OF THIS WITH THE GDPR, IT WOULD MAKE MY LIFE EASIER, BUT I'M VERY ENCOURAGED BY THAT. AND SO I REALLY THINK THAT'S ALL I HAVE TO SAY. AGAIN, VERY SMALL SLICE BUT I'M VERY ENCOURAGED BY WHAT I SEE HERE. >> TIM, LET ME ASK YOU THIS. ARE YOU GUYS GETTING QUESTIONS ABOUT WHETHER AND WHEN THESE STUDIES THAT DON'T NEED TO BE TRANSITIONED SHOULD BE TRANSITIONED? >> WE'RE STARTING TO GET THAT, YES. >> YEAH, AND WHAT ARE YOU SAYING? >> THE PEOPLE THAT ANSWER THAT AREN'T HERE SO I CAN'T REALLY SAY. >> OKAY, OKAY. OKAY, OKAY. >> CAN I MAKE ONE FOLLOW-UP COMMENT? >> OF COURSE. >> I THINK ONE THING, WE'RE THINKING ABOUT TEMPLATES, TO THE EXTENT THERE ARE ADDITIONAL PRIVACY CONCERNS, PARTICULARLY AROUND GDPR, MAYBE A PARTICULAR HIGH BAR STATE REQUIREMENT AROUND PRIVACY, IT WOULD BE GREAT IF CONCERNS COULD BE BUILT INTO WHAT BECOMES COMMON TEMPLATE OR COMMON RECOMMENDATIONS. EUROPE AND CALIFORNIA WHERE MY HEAD GOES TO IMMEDIATELY. BUT LOOKING EXCLUSIVELY JUST TO THE REGULATION AND NOT THINKING ABOUT SOME EXTERNAL COMPONENTS COULD RESULT IN SORT OF REVISIONS TO IT, OR DEVIATIONS SHOULD A COMMON TEMPLATE BE IDENTIFIED. >> TIM, YOU KNOW, I THINK BRINGING UP POINTS TO CONSIDER -- [ NO AUDIO ] [ PLEASE STAND BY ] >> AND THE INITIAL CONSENT SO I THINK WE HAVE TO CAPTURE EXACTLY WHAT SLICE OF INFORMATION IS POSTED SOMEHOW TO REFLECT ALL OF THAT. THAT SAID, PFIZER BELIEVES OF COURSE IN THE PRINCIPLES OF TRANSPARENCY, IN THE CLINICAL TRIAL -- IN CLINICAL TRIALS AND IN THE RESEARCH COMMUNITY AS A WHOLE, AND WANTS TO FACILITATE THE DEVELOPMENT OF BETTER INFORMED CONSENT FORMS. AS SUCH, PFIZER WILL BE PREPARED TO COMPLY WITH ANY SUCH APPLICABLE REQUIREMENTS, IT WILL BE HELPFUL IF THERE IS ADDITIONAL CLARITY ON THE TYPE OF INFORMATION THAT MAY BE REDACTED. PFIZER BELIEVES THAT EXAMPLES OF REDACTIONS THAT WOULD BE PERMISSIBLE SHOULD INCLUDE ANY COMPANY CONFIDENTIAL OR PROPRIETARY INFORMATION THAT IS NOT PUBLICLY AVAILABLE SUCH AS SAFETY PROFILE OF AN INVESTIGATIONAL MEDICINE THAT IS NOT YET MARKETED. REDACTING THIS TYPE OF INFORMATION WOULD FURTHER GOALS OF TRANSPARENCY AND INFORMED CONSENT FORM, AND FACILITATE DEVELOPMENT OF BETTER FORMS WHILE OF COURSE PROTECTING PROPRIETARY INFORMATION OF SPONSORS. THIRD, ON THE ISSUE OF RECONSENT, PFIZER AGREES WITH THE RECOMMENDATION THAT RECONSENT SHOULD NOT BE NECESSARY IN THE SITUATION WHERE SUBJECTS WHO HAVE PROVIDED INFORMED CONSENT MEET THE REQUIREMENTS OF THE PRE-2018 COMMON RULE. HOWEVER, WITH RESPECT TO THE RECOMMENDATION FOR RECONSENT FOR ALL ONGOING STUDY PARTICIPANTS, WHERE THE IRB REQUIRES RECONSENT FOR AN INDEPENDENT REASON SUCH AS THE ONES MENTIONED EARLIER FOR SAFETY, UPDATES, OTHERWISE, PFIZER HAS THE FOLLOWING ADDITIONAL STATEMENT FOR THE COMMITTEE'S CONSIDERATION. PFIZER BELIEVES IN THE PRINCIPLE OF RESPECT, FOR RESEARCH PARTICIPANTS. APPLYING THAT PRINCIPLE IN THE SCENARIO WHERE THERE'S A NEED TO RECONSENT FOR INDEPENDENT REASONS, WE DO NOT BELIEVE THAT THE REVISED COMMON RULE CONSENT REQUIREMENT SUCH AS KEY INFORMATION OR UP-FRONT SUMMARY MEANINGFULLY ADVANCED THAT PRINCIPLE. FIRST FROM A PARTICIPANT PERSPECTIVE, THE INFORMED CONSENT FORM COULD POTENTIALLY LOOK VERY DIFFERENT FROM THE INITIAL FORM THAT COULD RAISE QUESTIONS FOR THAT PERSON ON WHY THE FORMAT OR PRESENTATION HAS CHANGED, IF ALL THE PRIOR INFORMATION THEY ALREADY AGREED TO IS STILL ACCURATE. WITH THE EXCEPTION OF COURSE OF THE NEW INFORMATION. SECOND, IF REQUIRED FOR ALL ONGOING STUDIES, THIS COULD HAVE THE IMPACT OF HAVING CERTAIN PARTICIPANTS RECEIVE THE SAME INFORMATION IN DIFFERENT WAYS FOR THE SAME STUDY. SIMPLICITY AND RESPECT FOR THE RESEARCH PARTICIPANT CALLS FOR ONLY TRULY NEW INFORMATION TO BE PROVIDED TO STUDY PARTICIPANTS, SO THAT EACH PARTICIPANTS MAY MEANINGFULLY MAKE THAT DETERMINATION IF THEY WOULD LIKE TO CONTINUE IN A STUDY OR NOT. THAT SAID, IF RECONSENT UNDER THE REVISED COMMON RULE CONTENT REQUIREMENTS WILL BE REQUIRED FOR ALL ONGOING STUDY PARTICIPANTS, IT WILL BE VERY HELPFUL FOR THE RESEARCH COMMUNITY TO HAVE ADDITIONAL CLARITY ON HOW THIS REQUIREMENT WILL BE IMPLEMENTED. FOR EXAMPLE, CAN THERE BE CERTAIN CRITERIA FOR IRBs TO USE WHEN DETERMINING WHETHER AN ONGOING STUDY FOR WHICH THERE'S AN INDEPENDENT REASON TO CONSENT SHOULD DO SO USING A CONSENT FORM THAT REFLECTS THE REVISED COMMON RULE REQUIREMENTS. CAN THERE BE AN IMPLEMENTATION APPROACH THAT TAKES INTO ACCOUNT AN ONGOING STUDY'S TARGETED COMPLETION DATE? FOR EXAMPLE, WHAT IF A STUDY IS DUE TO COMPLETE IN A FEW MONTHS WITHIN 2019? ADDITIONAL GUIDANCE ON THESE REQUIREMENTS FOR RECONSENTING IN ONGOING STUDIES WOULD BE VERY HELPFUL. TURNING TO THE RECOMMENDATIONS ON CONSENT REQUIREMENTS, PFIZER IS IN AGREEMENT WITH THE FDA'S MOST RECENT GUIDANCE THAT CLARIFIED THE REVISED COMMON RULE'S REQUIREMENTS RELATING TO CONTENT, ORGANIZATION AND PRESENTATION OF INFORMATION IN THE INFORMED CONSENT FORM AND THE PROCESS AS WELL AS THE NEW BASIC AND NEW ADDITIONAL ELEMENTS OF INFORMED CONSENT ARE NOT INCONSISTENT WITH THE FDA'S REGULATIONS FOR HUMAN SUBJECT PROTECTION. THUS PFIZER BELIEVES IN THE INTEREST OF PATIENTS AND RESEARCHERS AND STREAMLINED REGULATIONS, THAT AVOID UNNECESSAR ADMINISTRATIVE BURDEN WHILE PROTECTING RESEARCH PARTICIPANTS THERE'S NO NEED FOR TWO DIFFERENT INFORMED CONSENT FORMS. IN FACT, PFIZER HAS ALREADY UPDATED OUR INFORMED CONSENT DOCUMENTS TO ALIGN WITH BOTH REVISED COMMON RULE AND FDA REGULATIONS. WE NOW INCLUDE A CONCISE AND FOCUSED PRESENTATION OF THE KEY INFORMATION THAT IS MOST LIKELY TO ASSIST SUBJECTS OR REPS IN UNDERSTANDING THE REASONS ONE MIGHT OR MIGHT NOT WANT TO PARTICIPATE IN THE RESEARCH AND ORGANIZED AND PRESENTED IN A WAY THAT FACILITATES COMPREHENSION. FOR EXAMPLE, PFIZER'S ICD NOW STARTS WITH AN OPENING WELCOME LETTER THAT INCLUDES THAT PARTICIPATION IS VOLUNTARY, INCLUDING THE RIGHT TO CHANGE THAT DECISION AT A LATER DATE, ENCOURAGING PARTICIPANT TO SPEAK WITH THEIR FAMILY, CAREGIVERS, DOCTORS AND THE STUDY TEAM ABOUT THE STUDY AND WHETHER IT IS RIGHT FOR YOU. AND BRIEFLY INTRODUCES THE POSSIBILITY OF OPTIONAL ACTIVITIES SUCH AS COLLECTION OF BIOLOGICAL SAMPLES FOR OPTIONAL ADDITIONAL RESEARCH. PFIZER'S ICD ALSO INCLUDES A CONCISE SUMMARY OF THE STUDY. AND I THINK SIMILARLY WE'VE ALIGNED OUR CONSENT TO THE NEW BASIC ELEMENT OF CONSENT REQUIRING THE STATEMENT THAT IDENTIFIERS MIGHT BE REMOVED FROM THE DATA, AND NON-IDENTIFIED DATA COULD BE USED FOR FUTURE RESEARCH OR DISTRIBUTED TO ANOTHER INVESTIGATOR FOR FUTURE RESEARCH. IN SUMMARY I THINK OUR EFFORTS HAVE SHOWN THAT IT IS IN FACT POSSIBLE FOR THE TWO UNIVERSES TO COEXIST IN A SINGLE INFORMED CONSENT TEMPLATE. TURNING TO DRAFT RECOMMENDATION ON HARMONIZATION BETWEEN COMMON RULE AND FDA RECOMMENDATIONS PFIZER COMPLETELY AGREES WITH EACH OF THE POINTS RAISED IN THE DRAFT RECOMMENDATIONS CALLING FOR HARMONIZATION BETWEEN REVISED COMMON RULE AND FDA REGULATIONS. MAJORITY OF CLINICAL TRIALS ARE NOT IN THE CATEGORY OF FEDERALLY FUNDED RESEARCH, I THINK AS WE'VE HEARD HERE TODAY THE MAJORITY OF OUR CLINICAL TRIAL SITES ARE IN THAT CATEGORY, AND ARE THUS SUBJECT TO COMMON RULE, REVISED COMMON RULE'S REQUIREMENTS. AS SUCH, WHAT THAT MEANS PRACTICALLY IS THAT THE SAME RESEARCH SITES WILL LIKELY BE RUNNING VARIOUS TYPES OF STUDIES, FEDERALLY FUNDED OR UNDER FDA JURISDICTION, OR IN SOME INSTANCES BOTH, AT ANY GIVEN TIME. AND A SINGLE CONSENT FORM TEMPLATE FOR ALL OF THESE STUDIES WOULD BE A MUCH SIMPLER AND PREFERRED APPROACH. BY NOT HARMONIZING THE INFORMED CONSENT REQUIREMENTS, THERE'S A POTENTIAL FOR CAUSING ADDITIONAL INDUE BURDEN ON CLINICAL TRIAL RESEARCHERS PRINCIPAL INVESTIGATORS, STUDY STAFF TO MAINTAINING TWO DIFFERENT TEMPLATES, IF NOT MANY MORE, BASED ON THE SOURCE OF FUNDING. THERE'S INCREASED POSSIBILITY FOR ERROR IF WRONG TEMPLATE IS USED. AND PRACTICALLY IT WOULD BE EASIER FOR SPONSORS TO GIVE CLEARER INSTRUCTIONS TO SITES IF THERE'S A SINGLE TEMPLATE. THEREFORE, TO AVOID AS WE HAVE ALREADY HEARD A BATTLE OF THE FORMS, AND TO PREVENT DEADLOCK IN THE NATIONAL AND INTERNATIONAL RESEARCH REVIEW AND APPROVAL PROCESS, PFIZER AGREES WITH THE DRAFT RECOMMENDATIONS IN THE SECTION ON HARMONIZING BETWEEN THE COMMON RULE AND FDA REGULATIONS. IN CLOSING, PFIZER BELIEVES THAT THROUGH PATIENT-FRIENDLY INFORMED CONSENT DOCUMENTS, STREAMLINED REGULATIONS, WE CAN ACHIEVE A SINGLE SHARED GOAL FOR ALL OF SOCIETY, TO BRING MUCH NEEDED MEDICINES TO PATIENTS AS QUICKLY AS POSSIBLE WITHOUT UNNECESSARY ADMINISTRATIVE BURDENS, WHILE PROTECTING THE VERY PEOPLE WHO MAKE THOSE MEDICINES A REALITY. THE RESEARCH PARTICIPANTS. THANK YOU. >> I HAVE QUESTIONS. FOR CLARIFICATION, YOU TALKED ABOUT NOT REQUIRING REWRITING THE WHOLE CONSENT, IF AN IRB DETERMINES THE RISKS ARE UPDATED SUCH THAT SUBJECTS HAVE TO BE INFORMED, AND THEY WERE PREVIOUSLY APPROVED ON THE PRE-2018 CONSENT. >> UH-HUH. >> DOES THAT SAME CONCERN HOLD IF THE CONSENT FORM WAS UPDATED ANYWAY? SO YOU HAVE SOME SUBJECT WHO IS WERE ENROLLED IN THE OLD FORM, SOME ON THE NEW FORM, WOULD YOU MAINTAIN TWO DIFFERENT FORMS THROUGH THE LIFE OF THE STUDY OR WOULD YOU TRANSITION TO THE NEW FORM, MAKE THE NEW CHANGES ON THE NEW FORM, I THINK YOU UNDERSTAND. >> YEAH, IT'S A FAIR QUESTION. I THINK THE SIMPLEST APPROACH WOULD BE TO ONLY HIGHLIGHT WHATEVER NEW INFORMATION IS WITHOUT NECESSARILY TRANSITIONING TO A NEW PRESENTATION OF INFORMATION THAT A PATIENT HAS ALREADY CONSENTED TO. I THINK THERE IS -- WE'D HAVE TO CONSIDER NEW PATIENTS, SO IN THE CASE OF A LONG-TERM STUDY WE'D HAVE TO CONSIDER WHETHER NEW PATIENTS ARE CONSENTED ON A NEW FORM VERSUS THE PRE-2018 ALTOGETHER. >> SO WE TALKED ABOUT THIS A LITTLE BIT AT THE SUBCOMMITTEE MEETING. AND MAYBE IT'S SOMETHING THAT IT WOULD BE HELPFUL FOR US TO MAKE EXPLICIT, BUT ONE OF THE ALTERNATIVES, I'M NOT AWARE OF ANY REGULATORY LANGUAGE THAT REQUIRES UPDATED INFORMATION TO BE PRESENTED ON AN UPDATED CONSENT FORM. AND WE CERTAINLY SEE PEOPLE USE ADENDA AND INFORMATION SHEETS, PERHAPS THAT'S A STRATEGY FOR ALL BUT THE MOST, YOU KNOW, SIGNIFICANT CHANGES THAT REALLY REQUIRE A FULL RECONSENT BY THEIR NATURE. PERHAPS THAT'S SOMETHING WE -- A STRATEGY WE SHOULD ENDORSE FOR THIS PURPOSE AS WELL. THEN THE OTHER THING, I THINK IT'S WONDERFUL PFIZER HAS BEEN PRO-ACTIVE AND DEVELOPED A TEMPLATE THAT'S COMPLIANT. IT RAISED THE ISSUE IF RESEARCH INSTITUTES, AND THOSE THAT HEATHER AND MEGAN TALKED ABOUT, WHAT DO YOU EXPECT PFIZER'S FLEXIBILITY WILL BE IF SOMEONE HAS A DIFFERENT KEY INFORMATION TEMPLATE AT ONE OF YOUR SITES? >> I THINK WE FACE THAT PROBABLY EVEN TODAY, RIGHT? IN THE CURRENT REGULATORY FRAMEWORK. I THINK SO LONG AS THAT FORM IS IN OUR VIEW COMPLIANT WITH THE APPLICABLE REQUIREMENTS, WE WOULD BE OKAY WITH THAT FORM. >> THANK YOU. I'M GOING TO SPEAK INTO THE MICROPHONE SO I APOLOGIZE FOR NOT LOOKING AT YOU. THANK YOU FOR THOSE COMMENTS, I THOUGHT THEY WERE VERY HELPFUL. TWO SORT OF QUESTIONS AND REMARKS. ONE IS I THINK IT'S A GREAT POINT TO NOTE THAT THERE'S AN INCREASING USE OF ELECTRONIC CONSENT AND HOW WILL WE INCORPORATE THOSE IN THE POSTING REQUIREMENTS, SO THAT RAISES A QUESTION FOR YOU, LAUREN, WHICH IS WITHIN EITHER OF THE POSTING MECHANISMS CAN IT FACILITATE POSTING A LINK OR SOME OTHER MECHANISM THAT WOULD ALLOW YOU TO EXPERIENCE THE CONSENT THE WAY THE PARTICIPANT MIGHT AS OPPOSED TO TRYING PDF AND ELECTRONIC INTERACTIVE DOCUMENT? >> YES, SO I BELIEVE THAT BOTH SYSTEMS CERTAINLY WOULDN'T STOP ANYBODY FROM POSTING A LINK INCLUDING THAT INFORMATION WITH THE CONSENT FORM ITSELF. BUT I KNOW, I BELIEVE 116(H) DOES SPECIFY THE INFORMED CONSENT FORM AND I THINK WE WOULD NEED TO CONSIDER HOW THAT WOULD BE INTERPRETED IN THE CONTEXT OF ELECTRONIC CONSENT. >> YEAH, IN OUR POINTS TO CONSIDER WE SHOULD EMPHASIZE THAT TO THE EXTENT ELECTRONIC PROCESS IS BEING USED SATISFYING THE REGULATORY REQUIREMENTS FOR FORMS ALSO THAT WE TRY TO ALLOW THE PUBLIC TO EXPERIENCE WHATEVER IT WAS THAT THE RESEARCH PARTICIPANTS ARE EXPERIENCING. THE OTHER POINT WAS ABOUT THIS QUESTION OF REDACTION, AND IT'S SOMETHING THAT I STRUGGLE WITH BECAUSE I HEAR COMMENTS ABOUT COMMERCIALLY PROTECTED INFORMATION, PRIVATE INFORMATION. THAT SAID, THESE DOCUMENTS ARE BEING PROVIDED TO RESEARCH PARTICIPANTS UNDER NO OBLIGATION TO KEEP THEM POTENTIAL AND IF THEY WANTED TO COULD POST THEM TO WHATEVER WEBSITE THEY WANTED TO DO SO. I DON'T WANT US TO GET TOO TIED UP IN THE IDEA OF REDACTION BECAUSE THEY ARE NOT REALLY PRIVATE DOCUMENTS, THEY COULD BE PUBLIC DOCUMENTS. WHILE I APPRECIATE THE STATED PURPOSE OF PUBLICLY POSTING CONSENT FORMS IS TO ALLOWS US IMPROVE THE CONSENT PROCESS AND LEARNING FROM DIFFERENT APPROACHES TO INFORMED CONSENT, AS SOMEBODY WHO DOES RESEARCH ON RESEARCH AND ON IRBs AND ON THE RESEARCH ENTERPRISE, IT IS INCREDIBLY DIFFICULT TO GET ANY WINDOW INTO THE SYSTEM, AND SO TO THE EXTENT THAT WE CAN MILK WHATEVER WE CAN OUT OF THESE PUBLICLY POSTED CONSENT FORMS, I THINK THAT IT'S IMPORTNT THING FOR US TO ENCOURAGE, SO GENERALLY SPEAKING I THINK WE SHOULD MINIMIZE REDACTION, AND ENCOURAGE THE TYPE OF POSTING THAT WILL BE MOST FACILITATIVE OF LEARNING AND SO ALTHOUGH THE REGULATORY REQUIREMENT IS NOT TOTALLY IDEAL, RIGHT, FROM A RESEARCHER'S PERSPECTIVE TO SAY IT CAN BE ANY FORM THAT WAS USED TO CONSENT PARTICIPANTS, WE MIGHT BE ABLE THROUGH SACHRP POINTS TO CONSIDER TO ENCOURAGE ENTITIES THAT HAVE TO POST ANYWAY TO POST THE SORTS OF MATERIALS THAT WILL BE MOST CONDUCIVE TO LEARNING AND FURTHER RESEARCH. >> I JUST WANT TO MAKE A COMMENT BECAUSE WE'VE TALKED ABOUT THIS AT PREVIOUS SACHRP MEETING. MY UNDERSTANDING OF THE INTENT OF THE POSTING IS NOT TO SUPPORT THE PUBLIC IN LEARNING ABOUT RESEARCH OPPORTUNITIES. AND I THINK THAT REQUIREMENTS THAT THE POSTING OCCUR 60 DAYS AFTER THE LAST STUDY VISIT SORT OF ENSURES -- ACTUALLY I THINK THE FACT IN A THERE'S PROPRIETARY RISK INFORMATION I WOULD FIND IT ACCEPTABLE TO REDACT THAT BECAUSE I DON'T THINK THAT THE PURPOSE OF THE FORM IS TO GIVE ANYONE THE IDEA OF A RISK PROFILE FOR PARTICULAR AGENT, BUT RATHER HOW WE WRITE CONSENT FORMS. SO I THINK MAYBE THAT'S ALSO SOMETHING WE NEED TO -- I DON'T KNOW THAT WE'VE BEEN EXPLICIT ABOUT OUR UNDERSTANDING OR IF EVERYONE AGREES. MARK? >> LET ME SAY THIS. WHAT I WOULD SUGGEST, THIS REDACTION ISSUE IS SOMETHING WE NEED TO DISCUSS FULLY. HEATHER, IF YOU COULD HOLD THAT TO THE NEXT SESSION, I THING WE NEED TO -- WE NEED TO TALK ABOUT IT AND HEAR FROM OHRP WHAT THEIR UNDERSTANDING HAS BEEN AND THEIR INTERPRETATION OF POSSIBILITY OF REDACTION, OKAY? ONE QUESTION, PARTHENA, ONE POINT, AND ONE QUESTION BEFORE WE MOVE TO A.J., THE QUESTION IS, YOU GUYS HAVE NOW A TEMPLATE THAT DOES COMPLY WITH THE NEW REQUIREMENTS, HAVE YOU BEEN USING THAT TO DATE IN NEW STUDIES, AND IF SO WHAT'S THE EXPERIENCE BEEN. >> YES, WE HAVE BEEN USING IT. AND WE IN GENERAL -- I HAVE NOT HEARD ANY SIGNIFICANT CHALLENGES WITH IMPLEMENTING THIS NEW CONSENT FORM THAT DOES INCORPORATE THE REQUIREMENTS OF THE REVISED COMMON RULE, AND WE ALWAYS SAY WE'RE ALIGNING TO IT BECAUSE, AGAIN, WE'RE NOT NECESSARILY REQUIRED TO FOLLOW IT BUT WE DO FIND MANY OF ITS REQUIREMENTS HELPFUL IN ADVANCING PATIENT FRIENDLY INFORMED CONSENT, AND THAT IS PFIZER HAS A PATIENT FIRST PHILOSOPHY, THIS IS ANOTHER EXAMPLE OF HOW WE'RE REALLY PUTTING PATIENTS AT THE CENTER OF WHAT WE DO EVERY DAY. >> SO YOU'VE NOT HAVE ANYBODY THROW THIS BACK IN PFIZER'S FACE, WE DON'T LIKE YOUR CONCISE STATEMENT, WE WANT OUR OWN CONCISE STATEMENT? >> NO, I HAVE NOT HEARD ANYTHING ALONG THOSE LINES. >> GOOD, OKAY. THAT'S GOOD. OKAY. AND THEN -- >> CAN I -- >> OF COURSE, GO AHEAD. >> I DID FIND IT INTRIGUING THAT THERE'S INTEREST IN STREAMLINING REGULATIONS, NOT SO MUCH INTEREST STREAMLINING INFORMED CONSENT DOCUMENTS. COULD YOU HELP ME UNDERSTAND WHY AT ONE COMPANY YOU WILL FIND INFORMED CONSENTS WRITTEN VERY DIFFERENTLY, YOU KNOW, MAYBE A PROBLEM COMES OUT OF EUROPE, MAYBE -- I DON'T REALLY UNDERSTAND WHAT HAPPENS, BUT I APPRECIATE YOUR COMMENTS ABOUT PFIZER'S INTEREST IN READABILITY FOR PATIENTS, BUT WHY DO I ROUTINELY, AS A MEMBER OF AN IRB, WHY DO I ROUTINELY SEE INFORMED CONSENTS FROM ONE COMPANY THAT ARE ALL OVER THE MAP IN TERMS OF READABILITY? >> I THINK YOU MENTIONED THE KEY SORT OF, QUOTE, ELEPHANT IN THE ROOM, WHICH IS LOCAL COMPLIANCE, RIGHT? LOCAL LEGAL, REGULATORY AND ETHICS COMMITTEE OUTSIDE THE U.S. FOR EXAMPLE SOMETHING AS SIMPLE AS LENGTH, IN SOME COUNTRIES THERE IS A PERMISSIBLE -- THERE WAS A MINIMUM -- THERE'S A MAXIMUM NUMBER OF PATIENTS, THAT'S WHAT I WANT TO SAY, RIGHT? THAT NUMBER OF PAGES IS MUCH FEWER THAN I THINK, YOU KNOW, WE'RE NORMALLY USED TO. IN EUROPE COMPANIES FROM 15-PAGE MAXIMUM REQUIREMENTS, RIGHT? WHICH EVEN THAT SOUNDS LIKE A LOT. BUT I THINK WE'RE ORDINARILY USED TO CONSENT FORMS THAT ARE -- THAT GO INTO ADDITIONAL DETAIL AND THUS TAKE ADDITIONAL NUMBER OF PAGES. SO I THINK IT'S REALLY, YOU KNOW, A RESULT OF COMPLIANCE WITH THE VARIOUS REQUIREMENTS THAT WE'RE SUBJECT TO, VARIOUS JURISDICTIONS. >> OKAY. IF THERE IS AN INTEREST IN LOCAL CONTEXT, I WOULD THINK THERE WOULD BE A MOTIVATION TO CREATE ONE SPECIFICALLY FOR THE UNITED STATES, FOR EXAMPLE, RATHER THAN HAVING IT REFERENCED USING EUROPEAN WORDS OR -- YEAH, JUST -- T W O CENTS. >> YEAH, AT PFIZER WE HAVE AN INFORMED CONSENT TEMPLATE AND DO HAVE VARIATIONS FOR DIFFERENT COUNTRIES. WE HAVE COUNTRY-SPECIFIC TEMPLATES. >> I COULD TRY TO ANSWER THE QUESTION IN ANOTHER WAY WHICH IS THAT, YOU KNOW, WITHOUT TALKING ABOUT ANY PARTICULAR COMPANY, THE LARGE AMERICAN PHARMA COMPANIES ARE NOT IN MANY CASES UNIFIED ORGANIZATIONS. THEY ARE CONGLOMERATIONS OF SMALLER COMPANIES, EVEN LARGER COMPANIES BOUGHT UP AND ARE BEING DIGESTED OVER TIME. AND SO IN MANY CASES WHAT'S OCCURRED IS THAT THE -- THERE ARE DIFFERENT PARTS OF A COMPANY WHICH REFLECT PREVIOUS COMPANIES, SMALLER COMPANIES OR LARGER COMPANIES SWALLOWED UP THAT HAVE THEIR OWN TEMPLATES, I'M NOT SAYING THIS ABOUT PFIZER OR NOT. >> THAT'S ANOTHER POINT. >> BUT THAT IS -- TO THE AVERAGE AMERICAN, OR OTHER PERSON, IT LOOKS AS THOUGH THE PHARMA AND DEVICE COMPANIES, THE LARGE ONES, ARE LARGE CORPORATE BEHEMOTHS BUTTER BUT -- BUT ARE IN MANY CASES COMPOSED OF SMALLER PROVINCES. >> [ INAUDIBLE, OFF MIC ]. >> IT DOES HAPPEN. IN GENERAL IT HAPPENS INCREMENTALLY BUT NOT IN A REVOLUTIONARY WAY IN THE EVOLUTION OF MOST CORPORATIONS LIKE THIS IN MY EXPERIENCE. PARTHENA, LET ME MAKE ONE POINT AND MOVE TO A.J. THIS GOES BACK YOUR AND STEPHEN'S COMMENT ABOUT FORMS, RECONSENT PROCESS THAT IS DECREED IN A -- BY THE IRB OR EVEN PROPOSED BY THE RESEARCHERS AND RATIFIED BY IRB, IN THAT CASE JUST SO THAT I CAN MAKE SURE THAT MY UNDERSTANDING AND THEREFORE OUR UNDERSTANDING IS THE SAME AS OHRP'S, FOR STUDY THAT HAS -- THAT WAS INITIATED BEFORE THE COMPLIANCE DATE, THAT STUDY AFTER THE COMPLIANCE DATE CAN CONTINUE IF IT IS NOT TRANSITIONED TO USE THE OLD FORM. AND THEREFORE, THE -- IF THERE IS RECONSENT ALL THE RECONSENTS CAN BE DONE USING AN AMENDMENT TO THE FORM THAT WAS COMPLIANT WITH THE OLD COMMON RULE, RIGHT? OKAY. AND SO JUST TO NARROW THE CIRCUMSTANCE THAT YOU'RE TALKING ABOUT, YOUR COMMENT IS ADDRESSING A STUDY THAT HAS TRANSITIONED, AND SO THAT SUBJECTS, NEWLY ENROLLED SUBJECTS, ARE BEING ENROLLED UNDER THE REVISED CONSENT FORM, AND THE OLD ONES AND THE SUBJECTS ENROLLED PRIOR TO THE TRANSITION DATE WERE ENROLLED WITH THE OLD FORM AND NOW THERE IS A RECONSENT PROCESS AND THE QUESTION IS IN THAT STUDY THAT HAS ACTUALLY BEEN DECIDED TO TRANSITION DO YOU NEED FOR THE SUBJECTS ENROLLED IN THE OLD CONSENT FORM NEED TO HAVE A NEW CONSENT -- A NEW FORM THAT ACTUALLY COMPLIES -- >> A WHOLE NEW DOCUMENT. >> OKAY, JUST TO BE CLEAR, TO NARROW THE CASE THERE. OKAY. THANK YOU. >> A LOT OF IT IS. >> A LOT OF IT IS. OKAY. FINALLY A.J. FROM ELI LILLY. >> THANK YOU FOR HAVING THE PANEL TO SACHRP AND OHRP, AND I THINK THIS HAS BEEN A GOOD DISCUSSION SO FAR. LET ME MAKE A COUPLE SPECIFIC POINTS. SO, ONE, I'M HERE, I WORK AT LILLY, AND I'M INVOLVED IN OUR RESEARCH ORGANIZATION THERE. I NOTED I'M ALSO I THINK THE ONLY PHYSICIAN AMONGST LAWYERS, WHICH -- TAKE IT FOR WHAT YOU LIKE. [LAUGHTER] AND I ALSO HAVE A PERSPECTIVE ON THIS, AS BEING A PATIENT ALTHOUGH I HAVEN'T PARTICIPATED IN TRIALS. I AM A PATIENT, A CANCER PATIENT. AND SO I'M INTERESTED IN THIS FROM BOTH THE IMPACT ON POTENTIALLY SCIENCE AND JUST THE OVERALL COMMUNICATION WITH PATIENTS IN GENERAL. YOU KNOW, I WANT TO GO BACK TO THE FDA GUIDANCE THAT WAS RELEASED BECAUSE I THINK IT'S HELPFUL BUT I ALSO WANT TO NOTE THAT NOT INCONSISTENT AT, SAY, ONE IRB WHERE MAYBE THE CONSENT IS NOT THE SAME AS CONSISTENT ACROSS IRBS OR ACROSS THE STUDIES THAT -- A TEAM MAY HAVE TO DEAL WITH. I ALSO WANT TO NOTE THAT, YOU KNOW, THIS IS A BIGGER ISSUE FOR THE SMALLER COMPANIES. LILLY IS ABOUT 30 TO 35,000, I THINK, SO WE'RE MEDIUM SIZED, BUT THEN THERE ALSO ARE MANY COMPANIES OUT THERE IN THE BIOPHARMACEUTICAL SPACE THAT MAY CONSIST OF 10, 15, EMPLOYEES. AND SO THEY ARE THE ONES THAT ARE MOST LIKELY GOING TO BE CAUGHT BY SURPRISE WITH THIS BECAUSE THEY ARE NOT NECESSARILY TRACKING ALL OF THESE THINGS IN REAL TIME, AND I WORRY EVEN THOUGH PFIZER HAS HAD A GOOD EXPERIENCE WITH THEIR UPDATED TEMPLATE THAT INCLUDES KEY INFORMATION SECTION, THIS IS GOING TO BE A REAL CHALLENGE FOR MANY OF THOSE SMALL COMPANIES BECAUSE I THINK FOR EXAMPLE KEY INFORMATION SECTION HAVING BEEN A MEMBER OF THE SUBCOMMITTEES AND PARTICIPATED IN THE DISCUSSIONS AROUND THAT, YOU KNOW, IF IT WAS CLEAR WHAT THAT WAS GOING TO BE, WOULD HAVE ALREADY MADE A RECOMMENDATION ON IT, AND THAT'S PART OF THE CHALLENGE THAT'S OUT THERE. I THINK THE WAY IT IS GOING, BASED ON THE DRAFTS THAT YOU'RE GOING TO DISCUSS I THINK IS GOING TO BE HELPFUL. BUT EVEN THAT'S NOT GUIDANCE. THAT'S SOME INFORMATION FOR OHRP TO CONSIDER AND FDA TO CONSIDER. THAT'S NOT GOING TO BE VERY HELPFUL TO PEOPLE THAT ARE WORKING AT DIFFERENT COMPANIES TRYING TO PREPARE A DRAFT OF AN INFORMED CONSENT OR AT LEAST IN TERMS OF BENEFITS AND RISK AND SUCH TO THEN GO OUT AND APPLY TO THE INDIVIDUAL SITES AT 20 IRBs ACROSS THE COUNTRY. SO THOSE ARE SOME OF THE OPERATIONAL CHALLENGES I THINK THAT THAT ARE GOING TO BE IN THERE, AND DEPENDING UPON THE COMPANY THEY ARE GOING TO HAVE TO WORK ON RETHINKING THEIR PROCESSES, RETHINKING HOW THEY DO THIS. EVERYBODY IN INDUSTRY RECOGNIZES THE IMPORTANCE OF INFORMED CONSENT FROM THE STANDPOINT OF, YOU KNOW, WE NEED TO DO THIS, WE NEED TO DO IT RIGHT BECAUSE IT'S CRITICAL TO HAVING PEOPLE TRUST THE RESEARCH PROCESS AND TRUST THE RESULTS, SO THAT AT THE END OF THE DAY WE MAKE ADVANCES IN HEALTH CARE, WHETHER AT NIH OR LILLY OR SOME SMALL BIOTECH COMPANY SOMEPLACE. THAT'S IMPORTANT. I THINK THE CHALLENGE HERE IN MANY RESPECTS IS GOING TO BE THE OPERATIONAL CHALLENGES, AND ALSO MAKING SURE THIS INFORMATION GETS OUT TO THE DIFFERENT ORGANIZATIONS, AND SO I THINK, FOR EXAMPLE, THE FDA GUIDANCE THAT WAS RELEASED ON FRIDAY ONE OF THE BENEFITS OF THAT IS THAT'S INSTANTLY GOING TO GET THE ATTENTION OF PEOPLE IN THE REGULATORY SCIENCE GROUPS AT MOST COMPANIES, EVEN IF IT'S ONE PERSON THAT SPLITS THEIR JOB WITH MAYBE LEGAL ROLES. SO THAT WILL HELP MAKE PEOPLE AWARE OF THIS. I DO THINK THAT THE GUIDELINES OR NOT THE GUIDELINES BUT RECOMMENDATIONS IN THE DRAFT SACHRP DOCUMENT ARE GOOD. I AGREE WITH PARTHENA ABOUT THE CONCERNS ON REDACTION, AND LET ME JUST THROW OUT ONE OTHER REASON THAT THERE'S CONCERN ON THE INDUSTRY SIDE REGARDING REDACTION, AND THAT'S THAT THERE HAS BEEN CASE LAW NOW APPARENTLY, I'M NOT A LAWYER BUT I TALK TO LAWYERS, AND APPARENTLY THE CASE LAW IS SUCH THAT A DISCUSSION IN -- [ NO AUDIO ] [ PLEASE STAND BY ]. >> ISSUING GUIDANCE ON INFORMED CONSENT, THAT SORT OF INTRODUCES THE POSSIBILITY WHAT IS CURRENTLY A SITUATION WHERE THEY ARE COMPATIBLE MAY RESULT IN A SITUATION THEY ARE NOW INCOMPATIBLE, I WAS CURIOUS WHY YOU THOUGHT IT WAS A GOOD IDEA. >> THE NOTICING COMMENT PROCESS WAS FOR REVISIONS TO THE CURRENT INFORMED CONSENT REGULATIONS FDA HAS. IN PARALLEL THERE'S ALSO A NEED FOR GUIDANCE THAT EXPLAINS IN MORE COMMON LAYMAN'S TERMS, MORE EASILY UNDERSTOOD, WHAT THOSE -- HOW THOSE REQUIREMENTS SHOULD BE INTERPRETED AND HOW THEY INTERPLAY WITH THE COMMON RULE REQUIREMENTS. I DON'T THINK THAT SHOULD FDA AND I BELIEVE THEY ARE IN THE PROCESS OF UPDATING THOSE REGULATIONS TO BE MORE HARMONIZED AND MORE CLOSELY ALIGNED WITH WHERE THE CURRENT OR NEW VERSION OF COMMON RULE IS, I DON'T THINK THEY THE ABILITY TO DEVIATE FURTHER FROM WHERE THEY ARE RIGHT NOW. MY UNDERSTANDING OR INTERPRETATION OF THE OVERLAP OR THE INTERACTION BETWEEN THE CURRENT NEW COMMON RULE AND THE EXISTING PART 50 AND 56 FDA REQUIREMENTS IS THAT WHILE THEY ARE NOT INCONSISTENT, THEY ARE NOT NECESSARILY HARMONIZED TO THE FULLEST EXTENT POSSIBLE. SO I'M NOT ADVOCATING FOR FURTHER OR CLOSER HARMONIZATION, I'M NOT POSITIVE THE CURRENT INFORMED CONSENT PART 50 AND 56 FDA REGULATIONS NEED TO BE UPDATED, I THINK THAT'S FDA'S DETERMINATION, SEEMS THEY ARE GOING DOWN THE ROAD THAT THEY WILL BE. BUT ONCE THEY ARE OR IF THEY ARE REVISING THOSE REGULATIONS IT SHOULD BE THROUGH NOTICE AND COMMENTING RULE MAKING WHERE INDUSTRY, STAKEHOLDERS, PATIENTS, SUBJECTS, CAN COMMENT ON WHAT THE NEW PROPOSED REGULATIONS WILL LOOK LIKE AND HOW THEY SHOULD BE INTERPRETED BUT I BELIEVE REGULATIONS ARE OFTEN WRITTEN MORE FOCUSED, MORE CLOSELY ALIGNED TO STATUTORY REQUIREMENTS AND CAN OFTEN PRESENT A CHALLENGE INTERPRETATION PARTICULARLY WHEN YOU GET DOWN TO THOSE SMALL COMPANIES, THE SMALL CLINICAL -- OR INDIVIDUAL CLINICAL INVESTIGATORS TO A CERTAIN DEGREE TO PATIENTS AND SUBJECTS THAT MAY BE DOING THAT ADDITIONAL LEVEL OF RESEARCH TO UNDERSTAND WHAT IT IS THEY ARE GETTING INVOLVED WITH WHEN THEY DECIDE TO BECOME PARTICIPANT IN THE CLINICAL TRIAL. DOES THAT CLARIFY? >> NOT REALLY. >> I'M SORRY. >> A.J., COULD I MAYBE TACK ON TO THAT, FDA HAD A DRAFT GUIDANCE WITH OHRP, 2016 OR SOMETHING LIKE THAT, THAT WAS ON INFORMED CONSENT. AND ACTUALLY WAS PRETTY WELL CONCEIVED, A FAIR NUMBER OF COMMENTS, BUT CERTAINLY WAS FELT BY MANY TO BE HELPFUL IN TERMS OF ADVANCING THE DISCUSSION. WITHIN INDUSTRY, THOSE SORTS OF DRAFT GUIDANCES, YOU KNOW, WE OFTEN TRY AND LOOK AT THOSE AND START INTERPRETING THEM VERY QUICKLY, EVEN THOUGH THEY ARE STILL DRAFT, RECOGNIZING THERE ARE SOME POINTS WHERE THERE MAY BE SOME CHANGE BUT CERTAINLY MUCH OF IT THAT'S LIKELY TO BE HELPFUL. ONE OPPORTUNITY I THINK FOR FDA MIGHT BE TO DO A REVISED DRAFT OF THAT, WITH OHRP, THAT TALKS TO THE CHANGES IN THE INFORMED CONSENT REQUIREMENTS THAT WOULD CERTAINLY GET SOMETHING OUT THERE, WOULD STILL ALLOW FOR COMMENT AND THAT BUT GIVE US SOMETHING TO WORK FROM THAT WOULD BE VERY HELPFUL. >> WOULD YOU PREFER THAT COMES THROUGH A NOTICE AND COMMENT PROCESS AND RULEMAKING PROCESS OR -- I MEAN YOU WERE SORT OF SAYING YOU PREFER THIS FORMAL PROCESS WHICH ALLOWS FOR A LOT MORE DISCUSSION THAN A GUIDANCE DOCUMENT, WHEREAS YOU SEEM TO BE TALKING ABOUT SOMETHING THAT SOUNDS MORE LIKE A GUIDANCE DOCUMENT. >> THERE ARE TWO SEPARATE PROCESSES. THERE IS A GUIDANCE PROCESS AND THEN THERE IS A RULEMAKING PROCESS. THE 21ST CENTURY CURES REFERENCE IS TO THE RULEMAKING PROCESS. AND SO I THINK THERE IS AN EXPECTATION OUT THERE TO THE EXTENT POSSIBLE FDA WILL HARMONIZE REGULATIONS WITH THE REGULATIONS IN THE COMMON RULE. SO THAT PIECE IS GOING ON AND I THINK THAT IT IS APPROPRIATE TO HAVE A COMMENT PERIOD ON THAT BECAUSE THERE MAY BE SOME ELEMENTS WHERE THERE'S DIFFERENCES IN THAT, AND IT'S HELPFUL TO HAVE THE INDUSTRY INPUT BECAUSE WE'RE ALSO TALKING ABOUT A DIFFERENCE BETWEEN GRANT MAKING AGENCIES AND REGULATING TRIALS THAT ARE DONE FOR THE PURPOSES OF REGISTERING DRUGS AND DEVICES. IN ADDITION TO THAT, I THINK THE GUIDANCE SERVES AN IMPORTANT ROLE, AND IT CAN BE VERY HELPFUL NOT ONLY TO, YOU KNOW, LARGE COMPANIES BUT PARTICULARLY THE SMALL COMPANIES THAT MAY NOT HAVE ANY OTHER RESOURCES TO GO THROUGH AND MAY HELP THEM QUITE A BIT IN THIS TYPE OF THING. >> OKAY. SO LET'S DO THIS. WE'RE SCHEDULED FOR A BREAK. LET'S TAKE A BREAK UNTIL 11:00. OKAY? AND THEN WE WILL COME BACK AND WE WILL RECONVENE THE PANEL. WE'LL LEAD OFF BY TALKING ABOUT THE POSTING REQUIREMENT AND REDACTION ISSUES AND TALK ABOUT WHATEVER ELSE EVERYONE WANTS TO TALK ABOUT IN REGARD TO WHAT'S BEEN DISCUSSED SO FAR. OKAY, STEPHEN? >> LET'S MAKE IT FIVE OF 11:00, THEN WE MIGHT ACTUALLY GET STARTED AT 11:00. >> OKAY, SOUNDS GOOD. >> THANK YOU ALL. THIS BRINGS UP TO ME HAVING REREAD THIS, FOR THE INDUSTRY REPRESENTATIVES HERE, I MEAN, GENERALLY THIS POSTING REQUIREMENT UNLESS IT IS FOLLOWED BY FDA IS NOT GOING TO APPLY TO MOST OF THE STUDIES, TO THE VAST MAJORITY OF THE STUDIES THAT ARE SPONSORED BY INDUSTRY BECAUSE THEY ARE NOT SUPPORTED BY A FEDERAL AGENCY. SO I'M WONDERING GIVEN THAT CONTEXT, THERE'S A LOT OF DISCUSSION ABOUT REDACTION, AND I DON'T -- I MEAN IF THIS WERE AN FDA REQUIREMENT I WOULD UNDERSTAND MORE THE CONCERN ABOUT REDACTION, BUT DO YOU NEVERTHELESS HAVE CONCERNS ABOUT REDACTION EVEN THOUGH THIS ONLY APPLIES TO POSTING OF FORMS THAT ARE IN STUDIES SUPPORTED BY A FEDERAL AGENCY? DOES THAT QUESTION MAKE SENSE? YES, A.J.? >> SO I GUESS IN SO FAR AS THIS IS SOMETHING THAT FDA HAS TO CONSIDER AS PART OF HARMONIZATION OF THE COMMON RULE, I THINK WHETHER IT APPLIES IN THE IMMEDIATE CASE OF THE TRANSITION ON JANUARY 21 OR AT SOME FUTURE DATE WHEN THEY PUT OUT A NOTICE POST RULEMAKING THIS IS SOMETHING THEY OUGHT TO KEEP IN MIND. >> OKAY. >> YOU MAY BE WORKING WITH INSTITUTIONS THAT IN THE PAST HAVE CHECKED THE BOX, THAT APPLIES THE SAME CRITERIA TO ALL OF THEIRS, AND THE INSTITUTIONS MAY HAVE FOR REASONS OF EITHER SIMPLICITY OR ETHICAL REASONS HAVE DECIDED TO CONTINUE THIS PRACTICE, IN WHICH CASE IT WOULD BE INVOKED AT THE INSTITUTION LEVEL, NOT THE FUNDER LEVEL. >> YES, YOU'RE RIGHT. THINK THAT'S THE BACKGROUND CONCERN IN ALL THIS REGARD, ALTHOUGH AN INSTITUTION COULD CONTINUE TO APPLY FEDERAL STANDARDS BUT NOT APPLY THE POSTING REQUIREMENT. >> I THINK THIS IS AN EXAMPLE OF WHERE THERE'S -- AT LEAST RIGHT NOW OR LIKELY TO BE OR COULD BE LIGHT BETWEEN THE COMMON RULE AND FDA REQUIREMENTS. THINK IT'S STILL TO BE DETERMINED, THIS IS AN EXAMPLE WHERE I COULD EXPECT TO SEE A DIFFERENCE BETWEEN THE REGULATION AND GUIDANCE IN TERMS OF WHAT DOES THAT DELTA LOOK LIKE AND HOW DO INSTITUTIONS APPLY FDA REGULAR DAYSES AND RULE TO THE SPECIFIC STUDIES THAT MEET THE REQUIREMENTS AND UNDERSTANDING THE DIFFERENCE WILL BE CRITICAL EVEN IF INFORMED CONSENT DOCUMENT IS IDENTICAL OR NEAR IDENTICAL ADDITIONAL REQUIREMENTS MAY NOT BE APPLICABLE, THAT'S WHERE THE CONFUSION COULD FALL. >> AJ? >> YEAH, TO USE THE EXAMPLE SANDRA GAVE, YOU COULD HAVE SOME INSTITUTIONS THAT CHECKED THE BOX THAT DECIDES DECIDE TO APPLY POSTING REQUIREMENT TO FDA REGULATED STUDY FROM SPONSOR, OTHER INSTITUTIONS DECIDED NOT TO APPLY THAT TO FDA-REGULATED INSTITUTION, WE'VE GOT, SAY, 25 INSTITUTIONS YOU'RE DEALING WITH, YOU COULD HAVE SOME THAT SAID THAT'S FDA RESEARCH, WE'RE NOT GOING TO DEAL WITH IT, THE OTHER QUESTION BECOMES WHICH IRB DECIDES FOR THE ENTIRE STUDY, IS IT THE LAST ONE TO HAVE -- WE DON'T KNOW WHO THAT'S GOING TO BE. >> RIGHT. >> A LOT OF OPERATIONAL CHALLENGES THERE. >> THERE IS, AND THIS IS THE REASON THAT I READ THE LANGUAGE BECAUSE FEDERALLY AGENCY DECIDES REACTION, IS THERE NO FEDERALLY AWARDING AGENCY WHO DECIDES ON THE REDACTION, AND THAT IS NOT SPECIFIED HERE AT ALL AND WON'T BE SPECIFIED UNTIL -- EVEN IF THE FDA REGULATIONS SPECIFY FOR FDA REGULATED RESEARCH THERE'S GOING TO BE A LOT OF RESEARCH THAT'S NEITHER FEDERALLY FUNDED NOR FDA REGULATED, SO IF INSTITUTIONS APPLY THE POSTING REQUIREMENT, WHO IS GOING TO DECIDE THE REDACTION? YEAH, HEATHER? >> A POINT I WANTED TO MAKE EARLIER IN THE DISCUSSION BEFORE THE BREAK WHEN WE WERE TALKING ABOUT, I THINK, HOLLY, YOUR REMARK'S VERY MUCH APPRECIATED ABOUT NEED FOR MORE AND MORE INFORMATION, THE OTHER PIECE THAT I THINK SACHRP SHOULD CONSIDER THAT WE DIDN'T DISCUSS IS THAT IF THERE'S CONCERN BECAUSE OF THESE VARIOUS STANDARDS AND NOT KNOWING WHAT WILL GET POST AND WHAT WON'T GET POSTED, IF THERE'S CONCERN FROM THE INDUSTRY PERSPECTIVE THAT THEY WON'T BE ABLE TO REDACT, THEN WE SHOULD AT LEAST CONSIDER WHETHER THERE WILL BE CERTAIN INFORMATION THAT MIGHT BE ON THE EDGE OF OPTIONAL BUT MIGHT BE HELPFUL THAT WOULD BE LEFT OUT OF INFORMED CONSENT DOCUMENTS BECAUSE IT MIGHT NOT BE REDACTED LATER. AND SO THE QUESTION OF, YOU KNOW, THE ULTIMATE REASON FOR HAVING THIS INFORMED CONSENT INFORMATION IS TO MAKE SURE THAT THE PERSPECTIVE SUBJECTS KNOW EVERYTHING THEY NEED TO. I WOULD HATE TO CREATE DISINCENTIVE THROUGH A RECOMMENDATION THAT NOTHING BE REDACTED, DISINCENTIVE FOR INCLUDING HELPFUL INFORMATION, IF THAT HELPS MAKE A DECISION. >> YEAH, MEGAN AND SANDRA. >> FURTHERMORE, AND I KNOW HEATHER RAISED THIS POINT EARLIER, THIS GIVES US PAUSE TO CONSIDER THE RECOMMENDATION ABOUT REQUIRING THE POSTING FOR STUDIES THAT HAVE TRANSITIONED, SO I THINK ONE OF THE THINGS TO CONSIDER IS IN THE ABSENCE OF CLEAR GUIDANCE ABOUT SOME COMPONENTS INCLUDING REDACTION, AND THE CROSS BETWEEN FDA REGULATIONS AND THE NEW RULE, HOW DO ORGANIZATIONS ACTUALLY OPERATIONALIZE THIS, IF IT WERE TO BE REQUIRED FOR STUDIES THAT HAVE TRANSITIONED EITHER THE BURDEN-REDUCING TIME OR WILL SOON TRANSITION AFTER THE POINT AT WHICH THE NEW RULE GOES INTO EFFECT, SO I THINK WE WANT TO REALLY BE CAUTIOUS ABOUT THE RECOMMENDATION THAT TRANSITIONING STUDIES MUST HAVE THAT POSTING IN THE ABSENCE OF GUIDANCE TO KNOW EXACTLY HOW TO OPERATIONALIZE THAT. >> I WANTED TO QUESTION WHETHER A CONSENT FORM BECOMES SOME SORT OF PUBLICLY UPLOADABLE INFORMATION, SIMPLY BECAUSE IT IS GIVEN TO PEOPLE WHO ARE PERSPECTIVE SUBJECTS. IN OTHER WORDS, CAN A CONSENT FORM REMAIN THE INTELLECTUAL PROPERTY OF THE DRUG COMPANY DURING THE PERIOD OF TIME WHEN PATIENTS ARE BEING CONSENTED AND THEY ARE BEING OFFERED THE OPPORTUNITY TO PARTICIPATE, AND THEY MAY SHOW IT TO THEIR FAMILY MEMBERS, AND THEIR PHYSICIANS AND WHATEVER, BUT THEY DON'T OWN IT AS INTELLECTUAL PROPERTY THAT THEY CAN CIRCULATE AT WILL. IT REMAINS THE INTELLECTUAL PROPERTY OF THE PERSON CONDUCTING OR THE ENTITY CONDUCTING THE CLINICAL TRIAL UNTIL SUCH TIME AS IT'S REQUIRED TO BE PUBLICLY POSTED, WHICH IS AFTER THE PATIENTS -- AFTER THE TRIAL ESSENTIALLY IS UNDERWAY OR OVER. I'M JUST SORT OF -- HOLLY, YOU WERE POSITING ONCE IT'S AROUND THEY COULD POST IT PUBLICLY BUT THEY DON'T NECESSARILY OWN IT AT THAT POINT. YOU CAN'T NECESSARILY POST PUBLICLY SOMETHING THAT YOU DON'T OWN. >> I THINK THEY COULD POST IT, UNLESS THEY WERE EXPLICITLY -- UNLESS AS A CONTRACTUAL MATTER THEY AGREED NOT TO POST IT. >> THIS HAS -- I'LL TELL YOU MY UNDERSTANDING OF THE LAW AND PREVAILING INTERPRETATION IS, AND ANYONE CAN FELL FREE ESPECIALLY OHRP OR FDA TO DISAGREE WITH THIS, MY UNDERSTANDING HAS ALWAYS BEEN THAT BECAUSE BOTH THE COMMON RULE AND FDA REGULATIONS SAY THAT ONE CANNOT FORCE A SUBJECT TO WAIVE HIS OR HER RIGHTS AS PART OF THE CONSENT PROCESS, THEREFORE IT'S NOT POSSIBLE TO ALLOW AN INFORMED CONSENT FORM OR ANCILLARY DOCUMENT GIVEN TO A SUBJECT OR PERSPECTIVE SUBJECT TO SAY YOU CANNOT DISCLOSE THIS INFORMATION PUBLICLY BECAUSE THAT WOULD BE A WAIVER OF A RIGHT TO DISCLOSE SOMETHING PUBLICLY. SO I THINK THAT MOST -- I'VE NEVER HEARD A DIVERGENT INTERPRETATION, NOT TO SAY THAT THERE CAN'T BE ONE, BUT I THINK MOST PEOPLE HAVE THOUGHT IT'S NOT POSSIBLE TO TELL SUBJECTS IN ANY KIND OF BINDING WAY THAT THEY CAN'T DISCLOSE THE CONTENT OF A CONSENT FORM OR OF A CONSENT CONVERSATION OR STUDY VISIT. NOW, THAT HAS COME UNDER SOME CRITICISM BY INDUSTRY BECAUSE FRANKLY THERE ARE SITUATIONS, AND WE HAVE IDENTIFIED -- I MEAN THE MEDIA HAS IDENTIFIED AND OTHERS, AND COMPANIES HAVE IDENTIFIED SITUATIONS, IN WHICH THERE HAVE BEEN FICTITIOUS PERSPECTIVE SUBJECTS SENT BY INVESTMENT FIRMS TO TRY TO ENROLL IN STUDIES TO GET -- AND TO ASK LOTS OF QUESTIONS OF THE STUDY DOCTOR TO GET AS MUCH INFORMATION ABOUT A DRUG OR DEVICE IN DEVELOPMENT IN ORDER TO BE ABLE TO TAKE THE INFORMATION BACK TO AN INVESTMENT FIRM AND SO THAT TO ALLOW THE INVESTMENT FIRM TO MAKE SOME DECISIONS. DON'T TAKE MY WORD FOR IT, THIS IS PUBLICLY REPORTED, IT'S IN THAT CONTEXT PEOPLE ASK THAT INDUSTRY SPONSORED HAVE ASKED CAN WE PUT A KIND OF -- I DON'T WANT TO SAY GAG CLAUSE, TOO STRONG A WORD, BUT AN OBLIGATION OF THE SUBJECT NOT TO DISCLOSE BECAUSE THAT WOULD DETER SUCH BEHAVIOR AND THE GENERAL ANSWER HAS BEEN NO, WE CAN'T. >> I WANT TO PURSUE THIS FOR ONE SECOND. THERE'S THE CONCEPT OF FAIR USE. A FAIR USE IS THAT YOU CAN SHOW IT TO YOUR DOCTOR, TO YOUR FAMILY, YOU CAN -- YOU KNOW, YOU CAN SEND IT TO SOMEONE WHO YOU WANT TO COMMENT ON IT FOR PERSONAL REASONS, BUT YOU CAN'T POST IT PUBLICLY FOR ALL TO SEE. >> IF YOU SEND ME A LETTER, I CAN POST IT. EVEN THOUGH IT'S YOUR DOCUMENT, RIGHT? I CAN'T PUBLISH IT AND PROFIT IT FROM IT. >> RIGHT. >> BUT I CAN POST IT, MY COPY OF IT. >> YOU CAN PUT IT ON FACEBOOK FOR OTHER PEOPLE TO READ. >> OKAY. >> (INAUDIBLE) [LAUGHTER] >> NO ONE SEND HOLLY ANYTHING. [LAUGHTER] >> HOLLY WILL ONLY SEND YOU PICTURES OF HER CHILDREN. >> RIGHT. >> OKAY. SO I FIND THIS VERY CURIOUS, I MEAN, MEDICAL CONFERENCES, SIDE EFFECTS, TOXICITIES ARE REPORTED OPENLY ALL THE TIME. AND I CAN GO ONLINE AND FIND OUT SIDE EFFECTS OF DRUGS THAT ARE IN DEVELOPMENT. AND THEN THERE ARE CLASSES OF DRUGS THAT SHARE SIDE EFFECTS. SO I'M JUST REALLY SO PUZZLED BY THIS CONCERN, THIS DESIRE FOR REDACTION OF SIDE EFFECTS, NOT TO MENTION AFTER A DRUG IS APPROVED, AND THEN THE AD IS RUNNING ON TELEVISION AND THREE MINUTES READING SIDE EFFECTS, AND IT REMINDS ME OF CHRIS ROCK SAYING DO YOU GO TO BED AND WAKE UP IN THE MORNING? >> SO I GUESS I WOULD SAY, YOU KNOW, WE FOCUSED EXCLUSIVELY ON STUFF RELATED TO SIDE EFFECTS. THERE MAY BE OTHER INFORMATION THAT IS IN AN INFORMED CONSENT AND OF INTEREST TO PATIENTS PARTICIPATING IN A TRIAL THAT MAY BE IMPORTANT NOT FROM, SAY, COMPETITIVE ASPECT BUT FROM AN INTELLECTUAL PROPERTY ASPECT, AND THAT AREA, MY UNDERSTANDING IS, AGAIN, I'M NOT A LAWYER BUT MY UNDERSTANDING FROM TALKING TO LAWYERS IS THAT THERE ARE SOME -- THE CASE LAW THERE IS EVOLVING. AND SO THAT IS AN AREA OF CONCERN THAT IS OUT THERE. I THINK IT'S EVOLVED SOME RECENTLY SO THAT MAY BE A PART OF IT. AND SO I WOULDN'T GET FOCUSED JUST OR EXCLUSIVELY ON, SAY, YOU KNOW, BENEFITS AND RISKS OR THAT TYPE OF THING. I WOULD ALSO KEEP IN MIND THERE MAY BE OTHER ISSUES, THE INTELLECTUAL PROPERTY CONCERN IS ALSO ONE THAT'S OUT THERE FOR INDUSTRY. >> CAN I ASK OHRP A QUESTION ABOUT THIS? IT'S A MORE GENERAL QUESTION BUT IT APPLIES TO THIS REQUIREMENT. FOR INSTITUTIONS THAT HAVE AN FWA, THAT IS NOT EXPIRED, AS OF THE TRANSITION DATE, AND THAT HAVE CHECKED THE BOX, THAT THEY AGREED TO APPLY THE COMMON RULE TO ALL OF THEIR RESEARCH, HOW DOES THAT -- HOW EFFECTIVE IS THAT FWA OPTION, HOW BINDING IS IT AFTE THE TRANSITION DATE ON THE NECESSITY OR ON THE PRACTICE THAT THEY MUST APPLY THE NEW COMMON RULE TO THE NON-FEDERALLY FUNDED RESEARCH, HAVE YOU GUYS THOUGHT ABOUT THAT AND TALKED ABOUT THAT? BECAUSE THAT DOES HAVE DIRECT APPLICATION TO THIS POSTING REQUIREMENT. >> IT'S A GOOD QUESTION. AND WE CERTAINLY ACTUALLY HAVE THOUGHT ABOUT IT AND TALKED ABOUT IT. I THINK THE BEST THING IS TO SAY WE'RE IN A LISTEN MODE HERE. IT'S A GOOD QUESTION, NAMELY HOW THAT SHOULD BE INTERPRETED IN TERMS OF CHANGE IN REGULATIONS. PROBABLY IT ALSO SHOULD BE VIEWED IN THE CONTEXT OF AS MANY ARE AWARE WE'RE BASICALLY PHASING OUT THE CHECK-THE-BOX REQUIREMENT, SO WHAT MEANS IN TERMS OF WHAT THE EARLIER COMMITMENT SHOULD MEAN, THERE'S A BUNCH OF QUESTIONS RAISED. >> THANKS. >> IT'S A GOOD QUESTION. AS IS TRUE WITH ALL OF THIS STUFF, WE'RE VERY MUCH MOVING FORWARD TOWARD PUTTING OUT GUIDANCE AND APPRECIATE HEARING ALL OF THESE QUESTIONS PRECISELY BECAUSE WE WANT AS MUCH GUIDANCE AS POSSIBLE TO ANSWER THESE QUESTIONS, AND WE WANT IT NT IT TO BE REASONABLE GUIDANCE. >> MAYBE WE SHOULD PUT IN OUR DOCUMENT GIVEN THAT EXTENSION OF THE POSTING REQUIREMENT, EVEN IF YOU EXTEND -- EVEN IF YOU INTERPRET CHECKING THE BOXES REQUIRING COMPLIANCE WITH STANDING REGULATION, THAT PERHAPS THERE SHOULD BE AN EXPLICIT EXCEPTION TO THE POSTING REQUIREMENT GIVEN THE TECHNICAL ISSUES AND OPERATIONAL ISSUES OF BRINGING INTO SCOPE THINGS FOR WHICH THAT LANGUAGE DOESN'T EVEN MAKE SENSE IN TERMS OF THE REDACTION AND AGENCY, MAYBE THAT'S SOMETHING WE SHOULD CAR. >> LET ME PROPOSE SOMETHING MORE RADICAL ENCOMPASSING THAT BUT MORE RADICAL, WHAT ABOUT A RECOMMENDATION THAT AFTER THE COMPLIANCE DATE THAT IF AN INSTITUTION'S FWA IS NOT EXPIRED THE OBLIGATION, THE LEGAL OBLIGATION TO COMPLY WITH THE COMMON RULE FOR NON-FEDERALLY FUNDED STUDIES SHOULD REALLY LAPSE AS OF COMPLIANCE DATE? >> I THINK THAT'S FINE. MY ONLY CERTAIN IS FOR STATES THAT REQUIRE COMPLIANCE WITH THE FEDERAL LAW AS PART OF STATE LAW AND HOW THAT WOULD PLAY OUT. >> YES, YOU'RE RIGHT, BECAUSE IN NEW YORK AND -- I WAS THINKING ABOUT THAT TOO. YEAH, DID YOU WANT TO SAY SOMETHING, MEGAN? YOU'RE DIRECTLY AFFECTED. >> THAT WOULD BE GREAT, YEAH, REALLY GREAT. I THINK SOMETHING THAT REALLY EXPLICITLY CALLS OUT THAT CHALLENGE AND SAYS THAT IT'S A REASONABLE INTERPRETATION TO INDICATE THAT YOU CAN STILL APPLY THE FEDERAL PROTECTION REQUIREMENTS WITHOUT HAVING TO ADHERE TO THE POSTING REQUIREMENT FOR A STUDY WHERE IT IS NOT DIRECTLY APPLICABLE, AND FOR A STUDY WHERE YOU CAN'T REALLY FULFILL THE REQUIREMENT BECAUSE THERE'S NOBODY TO ASK ABOUT REDACTION, I THINK THAT WOULD BE VERY, VERY HELPFUL FOR ORGANIZATIONS AND STATES THAT ARE STRUGGLING WITH THAT. >> MEGAN, WHAT DO YOU THINK ABOUT THE MORE RADICAL ALTERNATIVE THAT AS OF COMPLIANCE DATE THOSE INSTITUTIONS THAT HAVE AN FWA THAT HAVE CHECKED THE BOX ARE NO LONGER -- LET'S PUT IT THIS WAY, CAN ACTUALLY OPT AS TO WHETHER THEY WANT TO CONTINUE TO BE BOUND BY THE FWA FOR ITS -- UNTIL IT EXPIRES OR THEY CAN CHOOSE THAT FOR THE NON-FEDERALLY FUNDED RESEARCH THAT THEY DON'T WANT THE FWA TO APPLY TO THAT RESEARCH AS OF THE COMPLIANCE DATE? >> I THINK THERE ARE QUITE A FEW ORGANIZATIONS WHO WOULD FIND THAT INTERPRETATION FAVORABLE, IN THAT IT WOULD RELIEVE SOME ANXIETY ABOUT HOW TO DEAL WITH A TRANSITION AWAY FROM THE CHECKING THE BOX REQUIREMENT, AND HAVING SOME STATEMENT TO THAT EFFECT I THINK WOULD HELP PEOPLE THINK ABOUT HOW DO I MOVE FORWARD IN A WORLD WHERE THERE WON'T BE A BOX TO CHECK, I STILL DON'T KNOW THAT IT RESOLVES THE ISSUE FOR THOSE OF US WHO HAVE THE STATE LAW OBLIGATION. >> RIGHT, LONG-TERM, IT DOESN'T. >> BUT I DO THINK THAT ORGANIZATIONS WOULD FIND IT HELPFUL TO HAVE SOME DIRECTION TO SAY THIS IS HOW YOU CAN START TO THINK ABOUT THIS MOVING FORWARD, EVEN NOW. I THINK THAT WOULD BE A STEP IN THE RIGHT DIRECTION. >> OKAY. >> SO I WOULD AGREE THAT THAT WOULD BE HELPFUL STATEMENT FOR INSTITUTIONS THAT STILL DON'T QUITE KNOW WHAT CHECK THE BOXES GOING AWAY MEANS OR HOW TO IMPLEMENT THAT. I WOULD ALSO REQUEST THAT EMBEDDED IN THAT RECOMMENDATION IS ANOTHER SPECIFIC RECOMMENDATION ABOUT HOW THAT DECISION IS COMMUNICATED OR DOCUMENTED SO THAT IT'S CLEAR. >> RIGHT. >> THAT IT'S AN ACTUAL DECISION TO BE MADE AND DOCUMENT THE SOMEWHERE. >> I HAVE A BRIEF BUT PROBABLY OUT OF SCOPE QUESTION. ONE OF THE CONCERNS WHEN WE STARTED TO TALK ABOUT THIS MONTHS OR YEARS AGO WAS THAT THERE ARE STATE LAWS I THINK IT WAS NEW YORK. >> AND MARYLAND, THE TWO. THOSE ARE THE TWO. THERE'S ALSO ONE IN VIRGINIA, WHICH IS A LITTLE LESS CLEAR. >> THAT IF YOU DON'T ADHERE TO THE FEDERAL RULES, YOU WOULD HAVE TO ADHERE TO STATE LAW, WHICH HAS -- BECAUSE OF THE ABILITY OF, YOU KNOW, THE PRESENCE OF THE BOX AND THAT OPTION NO ONE'S EXPLOITED THAT AND THE STATES HAVE NO INFRASTRUCTURE OR EVEN PERHAPS REGULATORY BASIS FOR THEIR OWN, SO WE GET INTO THIS SORT OF LIMBO. >> RIGHT. BUT IN THE -- YES, BUT THAT'S WHY IN MY LAST ITERATION OF THIS POSSIBILITY I SAID THAT AN INSTITUTION THAT OUR RECOMMENDATION WOULD BE AS OF THE COMPLIANCE DATE FOR INSURE EXCLUSIONS THAT CHECKED THE BOX BUT FWA HAS NOT EXPIRED AS OF COMPLIANCE DATE THEY SHOULD BE ABLE TO CHOOSE WHETHER THEY WANT AS A LEGAL MATTER TO BE BOUND FOR THE FWA FOR NON-FEDERALLY FUNDED RESEARCH OR NOT, THAT WOULD ALLOW INSTITUTIONS IN NEW YORK AND MARYLAND TO SAY AS OF THE COMPLIANCE DATE WE STILL WISH TO -- LEGALLY TO BE BOUND TO APPLY THE COMMON RULE AND THAT WOULD GET THEM OUT OF THE PROBLEM FOR THE DURATION OF THEIR FWA, OKAY? >> IF WE DO THAT, WHICH IS THE RADICAL PROPOSAL, I COULD SUGGEST WE ALSO PUT SOMETHING IMPLICIT IF YOU ADOPT THAT, BECAUSE YOU HAVE TO BECAUSE OF YOUR STATE, WE STILL HAVE A PIECE ABOUT THE POSTING. >> EXACTLY. NO, I THINK THAT -- ACTUALLY THE POSTING NEEDS TO BE DISCUSSED IN THAT RECOMMENDATION BECAUSE THAT IS AN ILLUSTRATION OF THE DIFFICULTY HERE. >> I THINK I MIGHT BE MISSING SOMETHING THOUGH BECAUSE EVEN UNDER THE RADICAL APPROACH, IN MARYLAND, IF IT'S THE REQUIREMENT FROM THE STATE'S PERSPECTIVE YOU HAVE TO DO WHATEVER THE FEDERAL GOVERNMENT SAYS, AFTER THE TRANSITION DATE HAPPENS, RIGHT? FOR ALL OF THAT FUTURE RESEARCH, REGARDLESS OF WHETHER YOU CHECKED THE BOX OR HAVE AN FWA THAT'S EXPIRED OR WHATEVER, WOULD YOU HAVE TO POST. RIGHT? I JUST WANT TO MAKE SURE I'M CLEAR ABOUT THAT. >> WE WOULD. >> THAT'S WHY WE WOULD SAY IN THE RECOMMENDATION, THEORETICAL RECOMMENDATION IN REGARD TO POSTING, THAT BECAUSE THERE IS NO CLEAR PART -- BECAUSE THE REQUIREMENT ONLY SEEMS TO BE IMPLEMENTED IN REGARD TO FEDERAL FUNDING AGENCIES, FOR STUDIES NOT FEDERALLY FUNDED IT WOULD BE UP TO THE INSTITUTION, HOW, WHETHER, WHEN IF THAT APPLIES. >> THAT DOESN'T MAKE SENSE FROM A LEGAL INTERPRETIVE STANDPOINT, HOW COULD YOU APPLY A FEDERAL REGULATION THAT SAYS THE FUNDER HAS TO MAKE A DECISION IF THERE IS NO FUNDER. >> EXACTLY. >> FROM THE STATE'S PERSPECTIVE THAT'S SOMETHING THAT'S NOT APPLICABLE. >> OKAY. >> I WANT TO MAKE SURE THAT'S CLEAR. >> OKAY. >> THIS WAS A USEFUL DISCUSSION BECAUSE WE HAD NOT EXPLORED THIS BEFORE. SO-- OKAY. >> I WANT TO GO BACK TO ONE OTHER THING HEATHER HAD SAID, IF I'M UNDERSTANDING THE POINT CORRECTLY, THE WORRY IS THAT IF WE ENCOURAGE POSTING OF CONSENT FORMS WITHOUT REDACTION, THAT PERHAPS COMPANIES WOULD BE LESS FORTHCOMING IN THEIR CONSENT MATERIALS WITH PARTICIPANTS ABOUT MATERIALS, INFORMATION THAT THEY MIGHT BE WORRIED ABOUT BEING MADE MORE GENERALLY PUBLIC? >> THAT'S CORRECT, THAT IN THE BALANCE OF IS IT MORE IMPORTANT TO MAKE SURE -- NOW, THIS IS IF IT'S CRITICAL THAT SOMEONE KNOWS THAT WILL BE IN BUT IF IT'S ON THE EDGE BETWEEN THE CALCULUS, IS IT MORE IMPORTANT THAT WE TELL SOMEONE UP FRONT ABOUT THIS SAFETY PROFILE OR SOMETHING ELSE, OR TO MAKE SURE THAT THIS DOESN'T EITHER ON PURPOSE OR INADVERTENTLY GET RELEASED, MIGHT YOU DECIDE -- AND I DON'T KNOW THAT ONE IS WRONG WAY, WE'VE BEEN TALKING ABOUT INFORMED CONSENT DOCUMENTS THAT ARE LIMITED TO 15 PAGES, OR 20 OR 30 OR 50 PAGES LONG, AND SO IT MIGHT BE JUST FINE TO TAKE OUT THAT INFORMATION BECAUSE OF THAT WORRY BECAUSE NO ONE'S USING IT TO MAKE A DECISION BUT THE WORRY IS THAT YOU MIGHT CREATE AN INCENTIVE TO BALANCE THE OTHER WAY. >> IT WOULD BE HELPFUL I THINK TO HAVE A MORE SPECIFIC CONVERSATION ABOUT THE TYPES OF THINGS THAT MIGHT BE REDACTABLE, SO IT DOESN'T SEEM TO ME ALTHOUGH I SUPPOSE YOU COULD FIND ANY EXCEPTION TO THE RULE THAT A PARTICIPANT WOULD NEED TO UNDERSTAND LIKE THE MECHANISMS OF ACTION AND THE CHEMICAL STRUCTURE, ALL OF THOSE THINGS THAT ARE REALLY CRITICAL TO THE INTELLECTUAL PROPERTY, THAT'S NOT HELPING SOMEBODY MAKE THEIR DECISION BUT THE SAFETY PROFILE CERTAINLY IS, RIGHT? >> THAT'S THE EXAMPLE BROUGHT UP, THE IDEA OF REDACTING THE SAFETY PROFILE. >> THAT CONCERNS ME, REDACTING THE SAFETY INFORMATION FROM THE PUBLICLY AVAILABLE CONSENT FORM, THAT'S THE SORT OF THING THAT COULD BE USEFUL IN DEVELOPING CONSENT FORMS GOING FORWARD TO UNDERSTAND HOW THESE TYPES OF RISKS ARE DESCRIBED FOR EXAMPLE. AGAIN, I UNDERSTAND THIS IS NOT THE INTENDED REGULATORY PURPOSE, BUT IF YOU HAD A COLLECTION OF CONSENT MATERIALS THAT WERE PUBLICLY POSTED, WITH THEIR SAFETY PROFILES, YOU COULD HAVE A BETTER SENSE OF THE TYPES OF RISKS THAT WE'RE ASKING PEOPLE TO UNDERTAKE IN CLINICAL RESEARCH, RIGHT? SO I DON'T WANT TO SUGGEST THAT THERE'S NOT A VALUABLE LEARNING THAT COULD HAPPEN FROM THOSE -- THERE -- FROM THAT TYPE OF INFORMATION BUT THE SCIENTIFIC INFORMATION ABOUT HOW THE PRODUCT IS MANUFACTURED, THOSE TYPES OF THINGS, YES, REDACT AWAY BECAUSE THAT SHOULDN'T BE IN THE CONSENT FORM IN THE FIRST PLACE. IT WOULD HELP ME AT LEAST HAVE A MUCH MORE SPECIFIC CONVERSATION ABOUT WHAT WOULD BE REDACTABLE. >> I WANT TO CLARIFY, I WAS NOT SUGGESTING WE WOULD NEVER PROVIDE THE SAFETY PROFILE OF INVESTIGATIONAL MEDICINE, BUT I THINK WE DO HAVE TO THINK ABOUT IT IN THE CONTEXT OF SPECIFIC CLINICAL TRIALS, AND I THINK TO A.J.'S EARLIER COMMENT, SOME OF THAT COULD IN FACT BE, YOU KNOW, IN THE GRAY OF POTENTIAL, YOU KNOW, DESCRIPTIONS OF MECHANISMS OF ACTION AND OTHER TYPES OF PROPRIETARY INFORMATION, RIGHT? YOU COULD START GETTING INTO THAT AREA. SO I THINK I WAS TRYING TO SUGGEST AN EXAMPLE, IT WAS A VERY QUICK ONE, SO APOLOGIES FOR BROADLY INTERPRETING THAT AS NEVER EVER, BUT I THINK IT NEEDS TO BE DETERMINED ON A CASE-BY-CASE BASIS IN THE CONTEXT OF CLINICAL TRIALS >> I LIKE THE IDEA OF CASE BY CASE, I WOULD GO A STEP FURTHER TO SAY THAT WE SHOULD PROBABLY, IF OTHERS AGREE WITH THIS, SUGGEST THAT REDACTION WOULD BE THE EXCEPTION TO THE RULE AS OPPOSED TO THE EXPECTATION, SO THAT IT WOULD BE A MORE LIMITED -- CHANGING THE DEFAULT ABOUT WHAT THE EXPECTATIONS ARE. >> I WOULD BE CAUTIOUS ABOUT THAT BECAUSE SAYING THAT -- MAKING IT THE EXCEPTION TO THE RULE, THAT TENDS TO OFTEN -- WHO JUDGES THAT? AND IT CAN BE A VERY, VERY TRICKY ISSUE. THE CONCERNS I THINK PROBABLY IN MOST CASES, YOU KNOW, IN GENERAL, THE MOST SENSITIVE PARTS OF RESEARCH WHEN WE'RE DEALING WITH HUMAN SUBJECTS RESEARCH IS GOING TO BE THE EARLY PHASE TRIALS. PHASE 1 AND POTENTIALLY IN SOME CASES PHASE 2. SO, YOU KNOW, IT'S NOT THE BIG PHASE 3 TRIALS THAT MOST PEOPLE PARTICIPATE IN. >> CAN SOMEONE REMIND ME FROM OHRP OR FROM ANY ONE OF YOU, THIS REQUIREMENT FOR POSTING, DOES THIS REQUIREMENT FOR POSTING APPLY TO PHASE 1 TRIALS? I'M JUST NOT REMEMBERING EXACTLY. THINK IT DOES. >> FOR ALL CLINICAL TRIALS AS DEFINED BY THE NEW RULE. >> THERE'S NO EXCLUSION FOR PHASE 1 OR DEMONSTRATION STUDIES, NO? >> I MEAN IF IT MET THE CRITERIA FOR CATEGORY 5. >> OKAY. I THINK THAT'S THE ANSWER, HOLLY, IT'S REALLY IN THE PHASE 1 AND PHASE 2 TRIALS, ESPECIALLY PHASE 1 WHERE THERE MIGHT BE A DISCLOSURE ABOUT THE PRODUCT SINCE IT'S A FIRST-IN-HUMAN STUDY, YOU KNOW, WOULD THE DISCLOSURE SHADE OVER INTO CONFIDENTIAL INFORMATION. >> SOMEONE ELSE MENTIONED EARLIER IN THE CASE OF, YOU KNOW, A CLASS OF DRUG, RIGHT? WHERE THERE ARE KNOWN, YOU KNOW, SAFETY EVENTS THAT HAPPENED WITH A PARTICULAR CLASS, I THINK IT'S REALLY MORE IN THE MORE SENSITIVE AREA. >> I THINK ALSO DEVICE CONTEXT, A LITTLE DIFFERENTIATION BETWEEN PHARMACEUTICALS, IT DOESN'T NECESSARILY REQUIRE A Ph.D. IN TOXICOLOGY OR PHARMACOLOGY TO UNDERSTAND THE ACTION, THERE MIGHT BE MORE BEHIND THE PRINCIPLES WHICH COULD BLUR INTO THE I.P. CONFIDENTIAL INFORMATION THAT MIGHT BE DISCLOSED EVEN IN A HIGH LEVEL OVERVIEW OF THE DEVICE AND SAFETY PROFILE. >> YEAH, MEGAN, GO AHEAD. >> ONE OTHER THING RAISED BEFORE THAT SHOULD REALLY BE CONSIDERED IN THE CONTEXT OF RECOMMENDATIONS REGARDING REDACTION AS ALSO THIS SPECIFIC LABELING OF THE POINT IN TIME AT WHICH THAT CONSENT REPRESENTS, SO SINCE IT'S ANY CONSENT IT COULD BE VARIABLE IN TERMS OF WAS THIS YEAR 1, YEAR 5, WHERE WAS IT IN THE DEVELOPMENT OF INFORMATION THAT WAS ACQUIRED THROUGH THE LIFE OF THE STUDY, AND WHAT THAT ACTUAL SLICE OF INFORMATION REPRESENTS. SO I THINK SOME CATEGORIZATION OF THOSE DETAILS AND REQUIRED THAT THAT CONTEXT BE LISTED NO MATTER WHICH OPTION IS USED FOR POSTING, WOULD REALLY HELP GIVE FOLKS SOME COMFORT THAT THIS IS REALLY REPRESENTATIVE OF INFORMATION AT A POINT IN TIME, AND NOT LIVING BREATHING INFORMATION ABOUT A PRODUCT OR ABOUT A SPECIFIC RESEARCH PATHWAY. >> WE CAN ADD THAT TO OUR RECOMMENDATION. I THINK THE RECOMMENDATION WOULD BE A QUALITATIVE RECOMMENDATION THAT WHEN POSTING IS REQUIRED, WHEN IT'S GOING TO BE DONE, THAT PROVIDING FOR THE POSTER TO PROVIDE SOME CONTEXT AS TO THE TIMING AND THE POINT IN THE LIFE CYCLE OF THE TRIAL WOULD BE USEFUL. SO WE CAN -- I'LL ADD THAT IN. HOLLY, I WANTED TO -- THIS IS SORT OF -- THIS IS NOT THIS ISSUE BUT REMINDS ME OF THE CONVERSATION YOU JUST HAD WITH HEATHER, HEATHER'S POINT ABOUT THE POSSIBLE DISINCENTIVE EFFECT. THIS WAS ACTUALLY AN ARGUMENT THAT WAS MADE IN REGARD TO THE CT.GOV REQUIREMENT FOR POSTING OF RESULTS, AND ADVERSE EVENTS, NAMELY THAT THERE MAY BE AN UNINTENDED CONSEQUENCE OF THAT THAT WOULD LEAD INDUSTRY SPONSORS OF STUDIES TO DRAFT TRIAL PROTOCOLS IN A MORE NARROW WAY THAN THEY WOULD HAVE OTHERWISE AND GET THE DRUG OR DEVICE APPROVED ON A NARROW LABEL BECAUSE THEN THEY WOULD HAVE DISCLOSE FEWER RESULTS AND THEN LET IT BE SOLD OFF LABEL. SO THAT -- YOU KNOW, THAT HAS BEEN DISCUSSED AS A POSSIBLE UNINTENDED CONSEQUENCE OF RESULTS POSTING REQUIREMENTS IN CT.GOV, THAT'S AN ASIDE BUT IT'S AN ANALOGOUS ARGUMENT TO THE ONE THAT HEATHER WAS MAKING. ARE THERE ISSUES ABOUT -- ARE THERE OTHER ISSUES ABOUT THE TRANSITIONING STUDIES AND INFORMED CONSENT THAT WE NEED TO GO OVER OR THAT PEOPLE WERE UNCLEAR ABOUT? YEAH, GO AHEAD. >> SO IS THIS A GOOD TIME TO RETURN TO THE RECONSENT? >> YES, IT IS. YES. NOW IS THE TIME. >> OKAY. >> IF NOT NOW, WHEN? >> SO, THAT WAS I THINK THE BEGINNING OF A VERY IMPORTANT CONVERSATION, AND THE MORE THE CONVERSATION WENT ON THE MORE DIFFERENT EXAMPLES AND CASE STUDIES CAME UP, AND I THINK IT'S IMPORTANT THAT THE RECOMMENDATION ADDRESS ALL OF THEM. SO THE PIECE THAT STRUCK ME WAS THE ISSUE OF A RECONSENT, WHATEVER CIRCUMSTANCES BETWEEN SOMEONE WHO SIGNED A CONSENT FORM UNDER THE OLD RULE AND WHO IS NOW IN A STUDY THAT HAS TRANSITIONED TO THE NEW RULE, AND SO WE TALKED ABOUT I THINK VERY COMMON SENSE RECOMMENDATION ABOUT WHEN YOU WOULD USE WHICH FORMS. BUT THE DICHOTOMY WAS KIND OF MADE THAT IT SEEMED TO BE THAT IF THE REASON FOR RECONSENT WAS JUST FORMAT BECAUSE YOU'RE IN THE NEW RULE, THAT DOESN'T MAKE SENSE TO DO, RECONSENT SHOULDN'T BE AN ISSUE. IF INFORMATION WARRANTS A RECONSENT PROCESS THAT SHOULD BE DONE WITH THE NEW FORMS AND THEN THERE WAS A QUESTION THAT WAS RAISED AS TO WHETHER THAT SHOULD BE DONE BY UPDATING BOTH FORMS AND SO I JUST WANTED TO LAY OUT SOME OF THE BALANCE BETWEEN A VERY COMPLICATED BURDENSOME MAINTENANCE OF A FORM BANK TO REMEMBER WHO SIGNED WHAT, WHEN, AND THEN WHO DID WHAT, AND THE SIMPLICITY OF A MORE OF A A ONE-SIZE-FITS-ALL APPROACH WITH THE CAVEAT THAT GIVING SOMEONE A NEW CONSENT FORM WHO SIGNED THE PREVIOUS ONE UNDER THE OLD DOCUMENT COULD HAVE TWO UNINTENDED CONSEQUENCES. ONE IS THAT A CHANGE IN FORMAT MIGHT SUGGEST THAT THERE ARE MORE -- AS SOMEONE SUGGESTED THERE ARE MORE SIGNIFICANT CHANGES THAN THERE REALLY ARE. THIS LOOKS TOTALLY NEW. THERE WAS NOTHING UP FRONT BEFORE, THE WORDING IS DIFFERENT, PUT IN LAY LANGUAGE, IS THAT DIFFERENT THAN WHAT SOMEONE DESCRIBED A YEAR AGO. THAT WOULD BE ANXIETY PRODUCING AND COULD REQUIRE EXPLANATION. ON THE OTHER HAND AN EQUALLY OR BIGGER WORRY IS THAT A NEW FORM WITH A CHANGE IN FORMAT MIGHT MASK THE VERY IMPORTANT PIECE THAT YOU'RE TRYING TO UPDATE FOR. SO REALLY THE IRB HAS DECIDED THERE IS NEW SAFETY INFORMATIN THAT IS SO IMPORTANT IT IS WORTH RECONSENTING, BUT IT IS REALLY ONE NEW PARAGRAPH, THE PRESENTATION OF A FORM THAT LOOKS ENTIRELY DIFFERENT AND STRUCTURED ENTIRELY DIFFERENT BUT HAS ONLY ONE NEW PIECE OF INFORMATION COULD GET LOST. SO I WOULD HOPE SOMEWHERE THERE'S A TEASING OUT OF THAT A BIT AND THAT SOMEWHERE THERE'S AT LEAST THE ACKNOWLEDGMENT THAT IF THE IRB REQUIRES A RECONSENT AND AN INDIVIDUAL OR SET OF INDIVIDUALS ARE BOTH TRANSITIONING TO NEW INFORMATION AND A NEW FORMAT THAT THERE BE SOME EXPLICIT COMMUNICATION OR COVER LETTER OR SOMETHING THAT SAYS THERE'S TWO CHANGES, ONE IS WE'VE REDONE THE FORM BECAUSE WE HAD TO REDO THE FORM, BUT WE NEED TO MAKE SURE THAT YOU UNDERSTAND THIS IS WHY WE'RE DOING THIS NOW. >> WHAT ABOUT LIKE A LITTLE ROOF ON THE EXISTING RECOMMENDATION BASED ON THAT AND WHAT WAS SAID WHICH WOULD BE WHEN THERE IS A STUDY THAT'S TRANSITIONED, NEW INFORMATION THAT MUST BE IMPARTED TO ALL SUBJECTS, IT WOULD BE WITHIN THE DISCRETION OF IRB FOR THE REASONS YOU ARTICULATED TO CONTINUE TO USE THE OLD FORM, BUT WITH THE REQUISITE AMENDMENT THAT WOULD BE WITHIN THE DISCRETION OF THE IRB TO DO THAT? >> I THINK THAT WOULD PROBABLY BE IDEAL IN THE BALANCE OF DO WE STILL HAVE THOSE OLD FORMS OR DO WE KNOW WHAT VERSION THE PERSON SIGNED OR IS THERE A COMPELLING REASON TO DO IT THE OTHER WAY, SLAG IN THE DISCRETION OF THE -- HAVING THAT IN THE DISCRETION OF THE IRB BUT TWO OPTIONS WOULD BE A WAY TO GO. >> I WANT TO MAKE EXPLICIT THE THIRD OPTION, NOT TO REVISE THE CONSENT FORM. YOU'RE IN THE HABIT OF DOING THIS. >> RIGHT. >> SO YOU HAVE TO REVISE THE CONSENT FORM ANYWAY FOR ALL THE PEOPLE TO COME IN THE FUTURE SO IT'S EASIER TO GET EVERYBDY TO SIGN IT AGAIN. IT'S 20 PAGES, 30 PAGES LONG. SOMEWHERE IN THE MIDDLE IS A CHANGE BURIED, I THINK USING AN ADDENDUM IN THAT CIRCUMSTANCE IS PROBABLY ETHICALLY OR SUBJECT FRIENDLY ADVANTAGEOUS, WE DON'T DO IT BECAUSE IT'S YET ANOTHER DOCUMENT BUT IN THIS CIRCUMSTANCE I THINK THAT'S SOMETHING THAT WE SHOULD SERIOUSLY CONSIDER. . >> RECOMMENDATION WOULD PUT THAT AS THIRD ALTERNATIVE, TO GET IN AN EFFECTIVE BUT NON-CONFUSING WAY. >> WELL, JUST A QUICK COMMENT THAT IN THE IRB ALSO OUGHT TO HAVE THE OPTION, I'M AN OPERATIONAL PERSON, THE IDEA OF RECONSENTING EVERYONE STRIKES FEAR IN MY HEART. SO I'M WITH YOU. HOWEVER, I MEAN, THE IRB MAY LOOK AT THE CONSENT FORM AS IT EXISTS AND SAY, THIS WAS SO INCOMPREHENSIBLE WE DON'T THINK IT SHOULD BE CONTINUED AND WE THINK YOU SHOULD TRANSITION TO THE NEW CONSENT FORM, TAKING THE HIT WHERE YOU HAVE TO, BECAUSE THE OLD FORM IS TERRIBLE. AND THE NEW FORM IS SO MUCH BETTER. AND YOU ARE, YOU KNOW, YOU HAVE NOW TRANSITIONED YOUR STUDY AND WE THINK YOU REALLY OUGHT TO USE THE NEW FORM AND RECONSENT PEOPLE. I WOULD LIKE BOTH OF THOSE OPTIONS TO BE POTENTIALLY THERE FOR THE IRB, I'M COMPLETELY WITH YOU ON THE OPERATIONAL ISSUE. >> OKAY. >> SO MAYBE A REALLY AWFUL CONSENT FORM IS ONE OF THOSE COMPELLING CONSIDERATIONS FOR TRANSITION. [LAUGHTER] >> WHEN YOU DETERMINE IN RETROSPECT YOU VIOLATED HUMAN SUBJECTS PROTECTION BECAUSE YOUR CONSENT FORM WAS INADEQUATE, YES. THAT'S RIGHT. OKAY. >> YEAH, I THINK THE ALL-OR-NOTHING APPROACH WAS WHAT WAS TROUBLING IN TERMS OF REQUIRING ALL ONGOING SUBJECTS TO BE FULLY RECONSENTED. >> YES. >> BECAUSE OF THE TRANSITION. >> OKAY. I CAN CERTAINLY -- I CAN ACCOMMODATE THIS IN THE REVISION THAT I'M GOING TO DO IN A FEW MINUTES. ARE THERE OTHER PARTS OF THIS THAT YOU GUYS WANT TO TALK ABOUT? MEGAN? >> ON THE PRO CAUTIONARY NOTE, THE FIRST RECOMMENDATION, A GENERAL RECOMMENDATION THAT STUDIES NOT BE TRANSITIONED UNLESS THERE'S A COMPELLING JUSTIFICATION, AND I JUST WANT TO RESPECT THE REAL FACT ORGANIZATIONS HAVE ALREADY STARTED TO TRANSITION, AND IF THEY DO SEE GUIDANCE THAT SAYS DON'T TRANSITION, STOP NOW, UNLESS THERE'S A COMPELLING JUSTIFICATION, YOU MIGHT HAVE SOME WHICH DECIDE THEY NEED TO PANIC AND REVERSE COURSE. WHICH WOULD BE AN ADMINISTRATIVE NIGHTMARE. I THINK IF THERE COULD BE SOME POINT TO ADDRESS IF YOU'RE ALREADY STARTED, WE'VE GIVEN YOU RECOMMENDATIONS BELOW, HOWEVER IF YOU HAVEN'T WE WOULD ASK YOU TO THINK CAREFULLY AND THEN ADOPT THIS NEW STANDARD AND APPROACH OF COMPELLING JUSTIFICATION MOVING FORWARD, WOULD BE REALLY HELPFUL BECAUSE OTHERWISE I THINK THERE WILL BE THIS ONSET OF PANIC, AS PEOPLE SEE THAT STANDARD THAT THEY HAVEN'T SEEN BEFORE. >> SO MARK, WE'VE ONLY TALKED ABOUT IT IN PASSING AT THE BEGINNING BUT THE CONCLUDING SENTIMENT OF THE RECOMMENDATION IS REALLY IMPORTANT WHICH IS THAT THERE ARE GOING TO BE ORGANIZATIONS THAT ONLY WANT TO HAVE ONE SYSTEM AND SO THEY ARE GOING TO TRANSITION EVERYTHING. THEY ARE GOING TO BE ORGANIZATIONS WHO WON'T TRANSITION UNTIL THEY ABSOLUTELY HAVE TO. EVERYBODY'S GOING TO HAVE DIFFERENT STANDARDS FROM THE SPONSORS TO THE LOCAL CONTEXT, YOU KNOW, WE'RE ENTERING A TIME -- AND IT'S NOT JUST THE NEW ELEMENTS, AND IT'S NOT JUST KEY INFORMATION. BUT THERE'S LANGUAGE, YOU KNOW, THE FORMAT AND ORDERING OF THE CONSENT FORM IS SUPPOSED TO FACILITATE UNDERSTANDING, WE DON'T KNOW WHAT PEOPLE ARE GOING DO WITH THAT. SO WE MAY ACTUALLY HAVE DIFFERENT VERSIONS OF THE CONSENT FORM, NOW WE MAY HAVE DIFFERENT COMPENSATION FOR INJURY LANGUAGE, OR INSTITUTIONAL LIABILITY LANGUAGE. WE MAY HAVE VISIONS THAT ARE VERY DIFFERENT ABOUT HOW TO FILL THESE REGULATIONS, AND SINGLE -- AND SPONSORS AND IRBs MAY BE PARTICULARLY IN THE SINGLE IRB CONTEXT FACED WITH WILDLY VARYING -- UNTIL WE FIGURE THIS OUT, THAT'S NOT WHAT ANYONE WANTS. SO I THINK THAT IT'S REALLY IMPORTANT THAT THE DOCUMENT SPEAK TO FLEXIBILITY AND THE FACT THAT AT THIS MOMENT IN TIME AS WE TRANSITION TO A NEW SET OF RESEARCH REGULATIONS THAT WE KEEP IN MIND THE IMPACT OF OUR ACTIONS AND RESEARCH ENTERPRISE AS A WHOLE, NOT IN OUR PARTICULAR INSTITUTION OR PARTICULAR COMPANY, BUT EVERYTHING. >> SO, STEPHEN, I THINK THAT'S A GOOD POINT. I WONDER IF ONE OF THE THINGS THAT WOULD BE WORTH NOTING IS THAT WE'VE TALKED MOSTLY ABOUT THE REGULATIONS AND UP-FRONT PIECE OF THIS. I THINK IT MAY BE ALSO WORTH THINKING ABOUT PUTTING SOMETHING IN ABOUT THE OHRP AND FDA FORWARD DEALING WITH WHAT HAPPENS, WHAT ACTUALLY ENDS UP HAPPENING, AND AT THE END OF THE DAY THAT THERE'S A NEED TO CONSIDER WHETHER THE INTENT OF THE PEOPLE THAT ARE GOING THROUGH THIS TRANSITION, WHAT THEY ARE DOING IS CONSISTENT WITH TRYING TO FULFILL THESE REGULATIONS AS THEY UNDERSTAND THEM, AS OPPOSED TO SAYING, YOU KNOW, TAKE A RIGID HARD LINE WHICH I DON'T THINK IS THE CASE BUT I THINK THAT SORT OF COMPASSIONATE FLEXIBILITY ON HOW THEY -- AND UNDERSTANDING ON THE ACTUAL ENFORCEMENT COMPONENT IS . >> OKAY. >> AND WE I THINK -- YOU KNOW, A.J., YOU'RE FAMILIAR WITH KEY INFORMATION DOCUMENT BUT WE DO MAKE THAT POINT THAT WE'RE ONLY GOING TO SEE THE BENEFIT OF ALL THIS IF PEOPLE ARE ALLOWED TO FIGURE IT OUT AND TRY DIFFERENT THINGS AND I THINK WE SHOULD HAVE A STRONG RECOMMENDATION TO THE AGENCIES THAT ENFORCEMENT BE GUIDED BY -- JUST LIKE IRB DECISIONS, IF YOU FOLLOW THE RULES AND YOU HAVE THE RIGHT PEOPLE IN THE ROOM AND YOU FOLLOW THE PROCESS AND YOU CAN JUSTIFY IN A TRACEABLE WAY YOUR DECISIONS, THAT SOMETHING LIKE THAT SHOULD HOLD IN THIS CASE AS WELL, AS OPPOSED TO AS A.J. SAID RIGID COMPLIANCE. >> OKAY. SO, LET ME PROPOSE THIS. WE HAVE TIME ON THE AGENDA ACTUALLY TO GO OVER THE TEXT OF THIS RECOMMENDATION. WHAT I THINK WOULD BE MORE USEFUL, STEPHEN, IF THIS IS OKAY WITH YOU, IS FOR US TO BREAK WITH THIS PORTION OF THE AGENDA RIGHT NOW, AND LET ME GO OFF AND TRY TO ENCOMPASS AND INCORPORATE THESE THINGS IN THE DOCUMENT BEFORE WE START GOING THROUG IT. >> SO THAT MAKES SENSE TO ME. I WILL -- THE PANELISTS WERE ONLY EXPECTING TO BE HERE UNTIL 12:30, SO IT WILL BE UP TO YOU, THAT MAKES SENSE BECAUSE IT WILL GIVE US SOMETHING CONCRETE TO TALK ABOUT AND HAVE MOTIONS ON. >> RIGHT. >> BUT I'M RESPECTFUL OF YOUR TIME. YOU ARE ABSOLUTELY INVITED TO STAY AND CONTINUE TO PARTICIPATE, BUT WE ALL WILL UNDERSTAND IF YOU HAVE TO GO BACK TO WORK. SO -- >> THE ALTERNATIVE IS JUST TO GO NOW INTO THE DOCUMENT, INTO THE TEXT, WHICH WE CAN DO. AND THEN BREAK FOR LUNCH, AND THEN WHILE WE'RE AT LUNCH I'LL DO A FEW OF THE NIPS AND TUCKS, AND COME BACK. THE PANELISTS WOULD BE HERE FOR MOST OF THE CONTEXTUAL IT MAY NOT BE NECESSARY BECAUSE I THINK THE TEXT WE'VE ACTUALLY DISCUSSED, DISCUSSION AND CONSENSUS IS VERY MUCH REFLECTED IN THE TEXT. WHAT'S NOT REFLECTED IN THE TEXT ARE THE ADDITIONAL POINTS WE'VE JUST TALKED ABOUT. >> NO, I AGREE. I THINK THAT WOULD BE THE BETTER WAY TO GO. >> OKAY, OKAY. >> SO THANK YOU ALL. AND, AGAIN, YOU'RE MORE THAN WELCOME TO STAY AND PARTICIPATE. AND WHAT SOMETIME TIME IS LUNCH EXPECTED? PROBABLY 12:30. THOSE OF US ON THE COMMITTEE DON'T HAVE OUR LUNCHES YET AND WON'T FOR A LITTLE BIT OF TIME SO WE'LL PROBABLY MOVE TO THE NEXT TOPIC, IF PEOPLE ARE READY, WHICH IS KEY INFORMATION, IF PEOPLE ARE READY TO DISCUSS. PANELISTS, IF YOU WANT TO STAY AND LISTEN TO THE BEGINNING YOU'RE MORE THAN WELCOME TO. DOES THAT MAKE SENSE? SO DAVID, IS THAT OKAY WITH YOU? ARE YOU READY? >> SURE. IF YOU SAW ON YOUR PLAY BILL THE ROLE OF DAVID FORSTER IS PLAYED BY AN UNDERSTUDY TODAY, THAT WOULD BE ME. AND SO WHERE I'M GOING TO WALK US THROUGH THE DRAFT DOCUMENT, NEW INFORMED CONSENT REQUIREMENTS, AND THIS HAS BEEN BEFORE US BEFORE HERE IN THIS VENUE, NOT THIS PHYSICAL VENUE BUT THE SACHRP VENUE AND HAS GONE THROUGH ITERATIONS OF SUBCOMMITTEE REVIEW, FROM THE LAST SUBCOMMITTEE REVIEW WE THINK THIS DOCUMENT'S IN PRETTY GOOD SHAPE BUT AFTER THE DISCUSSION THIS MORNING IT PROBABLY WARRANTS A WALK-THROUGH. THERE'S THIS MAIN DOCUMENT WHICH INCLUDES NUMBER OF RECOMMENDATIONS FROM SACHRP, THERE'S ALSO SOME ANCILLARY MATERIALS THAT GO ALONG WITH IT, WE'LL SEE FROM A TIME STANDPOINT WHAT IF ANYTHING WE DO WITH THOSE. I'VE HAD A FEW COMMENTS ABOUT THE SUBSTANCE OF THOSE AND WHETHER WE'LL BE WORKING ON THEM BUT WE SHOULD START WITH THIS DOCUMENT, I KNOW THAT I BELIEVE THAT ALL THE SACHRP MEMBERS ARE IN AGREEMENT WE WOULD LIKE TO GET THIS DOCUMENT FINALIZE THE BY THE END OF THE MEETING, THIS IS OUR LAST CRACK BEFORE THE RULE GOES INTO EFFECT BASED ON THE TIMELINE OF SACHRP MEETINGS. NO PRESSURE BUT THAT'S OUR GOAL. LET ME MAKE SURE I HAVE THE TRACKING ON. I HAVE TO FIND THE TRACKING. RIGHT IN THE MIDDLE? OH, SHOOT. OH, THERE IT IS. OKAY. NOW THAT'S ON. AND WE CAN GET STARTED. SO IN THIS DOCUMENT WHICH WE'VE SEEN A FEW TIMES, IT STARTS WITH BACKGROUND ABOUT WHY WE HAVE THIS DOCUMENT, SACHRP WAS GIVEN A SERIES OF QUESTIONS BY OHRP RELATED TO SOME OF THE NEW CONSENT REQUIREMENTS TO CONSIDER. AND JUST GIVES SOME BACKGROUND, THE NEW ADDITION OF DEFINITION OF CLINICAL TRIAL, ET CETERA. STEPHEN, I DON'T KNOW IF YOU WANT ME TO JUMP INTO THE MEAT OR GO FROM, YOU KNOW, LINE ONE AND START WORKING THROUGH. I DON'T HAVE A STRONG PREFERENCE. >> I THINK YOU SHOULD BASICALLY STAND -- (INAUDIBLE). >> GOOD. LET'S DO THAT. THIS IS LARGELY BACKGROUND ON THE FIRST PAGE. AND TALKS ABOUT THE IDEA THAT, YOU KNOW, WE AS A GROUP BELIEVE THAT THIS -- THESE CHANGES TO INFORMED CONSENT PROVIDE AN OPPORTUNITY TO IMPROVE THE CONSENT PROCESS WITH THIS -- THESE CHANGES TO THE CONSENT FORM BEING THE VEHICLE THAT WILL DRIVE THAT, OBVIOUSY PROCESS IS DIFFERENT FROM THE FORM BUT THE PROCESS IS SUPPORTED BY THE INFORMATION IN THE FORM AND SO THAT CHANGES TO THE FORM THAT MAKE THE DECISION-MAKING PROCESS MORE TRANSPARENT AND OBVIOUS TO PEOPLE BEING PRESENTED WITH AN OPPORTUNITY TO BE IN RESEARCH SHOULD BE A GOOD THING. AND SO STARTING AT LINE 21 THAT LARGER PARAGRAPH TALKS ABOUT SOME OF THE REGULATORY LANGUAGE AROUND KEY INFORMATION, AND DOES NOTE THAT THERE'S THIS LENGTHY QUOTE ON LINE 23 THAT INFORMED CONSENT AS A WHOLE MUST PRESENT INFORMATION IN SUFFICIENT DETAIL RELATING TO THE RESEARCH, AND FACILITATES THE DECISION-MAKING PROCESS AND SO THAT KEY INFORMATION WHILE WE'RE FOCUSING ON SORT OF THE OPENING SECTION, YOU KNOW, THE REQUIREMENTS OF THE RULE REALLY GO BEYOND JUST THAT, THAT THERE IS SUPPOSED TO BE AN ATTEMPT BY THE AUTHORS OF CONSENT DOCUMENT TO HAVE CONSENT DOCUMENTS THAT AS CONCLUDES HERE BETTER SERVE ITS INTENDED FUNCTIONS AS DESCRIBED IN BELMONT. WITH THAT BACKGROUND -- OH. >> IN THE LAST ALMOST NEXT TO THE LAST LINE IN THAT PARAGRAPH, DON'T YOU WANT TO SAY FUNDAMENTALLY CHANGE AND IMPROVE THE CONSENT PROCESS AS A WHOLE, COMMA, TO BETTER SERVE? >> IT DOES. LET ME MAKE THE TRACKING TURN ON. >> YOU HAVE TO GO TO WHERE IT SAYS SIMPLE MARKUP. YEP, CHANGE IT TO ALL MARKUP. >> THANK YOU. >> YOU SHOULD SEE IT. >> AS WELL AS THE PROCESS? >> INCLUDING. >> INCLUDING THE FORM. OKAY. >> [ INAUDIBLE, OFF MIC ]. >> OKAY. AND THEN WE HAVE -- I'M GOING TO CLOSE THIS WE'VE GOT THE BACKGROUND, DEFINITION OF CLINICAL TRIAL, 116(A) 4 TALKS ABOUT THE PROVISION OF INFORMATION THAT THE REASONABLE PERSON WOULD WANT TO HAVE TO MAKE THEIR DECISION, AND THEN 116(A)5 GETS INTO THE IDEA THAT THE CONSENT HAS TO BEGIN WITH CONCISE AND FOCUSED PRESENTATION OF KEY INFORMATION SO I'M GOING TO SCROLL RIGHT PAST THIS BECAUSE THIS REALLY IS QUOTES FROM THE REGULATIONS, AND THEN SIMILAR TO WHAT WE HEARD IN MARK'S PRESENTATION THIS MORNING PREAMBLE SUGGESTS THESE FIVE THINGS WOULD BE AT THE CORE OF WHAT'S IN KEY INFORMATION, AND LINE 73, THE PREAMBLE DOESN'T HAVE THE WEIGHT OF REGULATION BUT GIVES SOME IDEA OF WHAT THE AUTHORS OF THE REGULATIONS WERE THINK WHEN THEY CAME UP WITH THE IDEA OF KEY INFORMATION. SO THAT'S THE BACKGROUND THAT LEADS US INTO COMMENTARY AND RESPONSES TO THE QUESTIONS THAT SACHRP WAS GIVEN BY OHRP. SO WE RECEIVED SIX QUESTIONS, AND AS WE WORKED THROUGH THOSE IT MADE SENSE TO US TO LUMP A FEW TOGETHER, SO 1, 3 AND 4 HAVE RESPONSES THAT APPLY TO ALL THREE OF THOSE QUESTIONS, AND THEN 2, 5 AND 6 WERE ANSWERED SEPARATELY AND ALL OF YOU ON THE COMMITTEE HAVE SEEN THIS DOCUMENT BEFORE, ADHERES TO THE SAME FORMAT WE HAD BEFORE. AND SO THE QUESTIONS, HERE ARE THE THREE QUESTIONS WE'VE LUMPED TOGETHER. HOW DOES KEY INFORMATION -- I'M GOING TO SUMMARIZE, HOW DOES KEY INFORMATION VARY DEPENDING ON CLINICAL TRIAL DESIGN AND THERE'S SOME EXAMPLES. QUESTION 3, CRITERIA THRESHOLDS OR STANDARDS THAT COULD BE IDENTIFIED TO DETEMINE WHAT INFORMATION SHOULD BE INCLUDED AS KEY. AND WHAT ARE THE JUSTIFICATIONS OR PRINCIPLES SUPPORTING THEM, AND THEN QUESTION 4 WAS GIVEN THE WIDE VARIETY OF TIMES AND COMPLEXITIES OF STUDIES AND DRUG DEVICE BIOLOGIC CONSIDERATIONS WHAT TOOLS OR STRATEGIES DO YOU RECOMMEND TO ASSIST INVESTIGATORS DETERMINING KEY INFORMATION, HOW DO THINGS LIKE TRIAL DESIGN FIGURE IN, THE TYPE OF STUDY THAT'S BEING COVERED BY THE CONSENT FORM, FACTOR INTO WHAT'S IN KEY INFORMATION. SO WITH THOSE QUESTIONS PRESENTED LET'S DROP TO THE RESPONSE TO THOSE. AND STARTING AT LINE 13, WE HERE AT SACHRP CONCLUDED THE DEVELOPMENT OF SUCH A TOOL IS NOT A SIMPLE MATTER, IN OTHER WORDS CAN WE PUT TOGETHER A TOOL THAT WOULD HELP US DISTILL THE INFORMATION ABOUT A DOCUMENT. NO, WE DON'T THINK SO. AND THAT, YOU KNOW, THERE'S A REAL CHALLENGE WHEN WE'RE LOOKING AT VARIABILITY AND TRIAL DESIGN, TIMES OF INTERVENTIONS, POOLS OF SUBJECTS THAT ARE POTENTIAL PARTICIPANTS IN STUDIES, TO SAY THERE'S GOING TO BE A TOOL THAT JUST SIFTS THAT OUT AND GIVES YOU THE ANSWER. WE COULDN'T COME UP WITH AN EXAMPLE OF THAT SO THERE ARE SOME TOOLS THAT TRY TO GET AT IT THAT ARE IN THE APPENDICES BUT WE WEREN'T ABLE TO IDENTIFY A SINGLE ONE THAT WOULD MAKE THAT WORK ACROSS STUDIES OF ALL TYPES. LINE 120, SACHRP RECOGNIZES SIGNIFICANT CREATIVITY EXISTS IN THE REGULATED COMMUNITY AND ENCOURAGES EFFORTS TO TEST TOOLS BECAUSE THERE'S GREAT VARIABILITY, MAY BE VARIABILITY IN CHOICE AND PRESENTATION OF KEY INFORMATION, THE CONCERNS ABOUT VARIABILITY SHOULD BE BALANCED, RECOGNITION OF IMPORTANCE OF FLEXIBILITY. AND THE EXISTING SYSTEM OF DRAFTING CONSENT FORMS AND CONTAINING CONSENT IS STAGNANT AND NEEDS TO IMPROVE. THAT'S OUR RESPONSE. COMMENTS? STEPHEN? >> I'M GOING TO CHANNEL MICHELLE WHO MADE THIS COMMENT TO ME LAST NIGHT, WE WERE ON THE SAME PLANE FROM BOSTON. AND SHE SAID THAT SHE TOOK AWAY FROM THOSE RULES THAT THERE'S -- I DON'T KNOW WHICH TOOLS SHE WAS REFERRING TO BUT THERE'S A LIST OF QUESTIONS, THAT SHE FELT WOULD BE A USEFUL THING PERHAPS TO PROMOTE TO THE CORE OF THE DOCUMENT AS OPPOSED TO APPENDIX AS A PLACE FOR PEOPLE TO START, WHAT THEY SHOULD ASK THEMSELVES. YOU KNOW, WHEN YOU START DOWN THIS PATH. I'M TRYING TO PULL THAT UP NOW. >> IS IT APPENDIX 2? ALL THE FOLDERS. OH, OKAY. SHOULD I SCROLL DOWN TO THAT? OKAY. I'M GOING TO GIVE YOUR EYEBALL AS WHIPLASH, SO HOLD ON. SO THIS IS APPENDIX 2, AND THIS WAS THE LIST OF QUESTIONS. TO HELP IDENTIFY WHAT WOULD BE KEY INFORMATION, AND THESE WERE EXAMPLE QUESTIONS THAT MIGHT HELP PEOPLE DESIGNING OR DEVELOPING FORMS TO GET TO THE HEART OF WHAT RISES TO THE TOP AS KEY INFORMATION. WE HAVE THIS AS AN APPENDIX. I DON'T KNOW IF WE TIE IT IN THE RESPONSE UP ABOVE TO THOSE THREE QUESTIONS TO SAY APPENDIX 2 INCLUDES A LIST OF QUESTIONS THAT -- >> SO I THINK WE SHOULD AT LEAST -- FIRST OF ALL DO PEOPLE AGREE THIS IS A PARTICULARLY USEFUL -- GIVEN WE'RE NOT ENDORSING ANYTHING IN PARTICULAR, THAT THIS IS MORE SPECIFIC AND WOULD BE USEFUL TO PEOPLE AS A PLACE TO START? NANCY? >> I THINK THE REASON WE DEMOTED IT TO AN APPENDIX WAS IT'S REALLY A STARTING PLACE, DOESN'T GIVE THE AMOUNT OF DETAIL THAT WE WERE SORT OF LOOKING FOR IN A TOOL. BUT IT'S A REALLY, REALLY GOOD STARTING PLACE. >> SO WE -- >> THAT'S DIFFERENT FROM OTHER APPENDIX MATERIAL. >> WE CAN SAY IN ANSWER TO THE QUESTION, MAKE THIS APPENDIX 1, THE FIRST ONE REFERRED TO, THE APPENDIX WHATEVER HAS A LIST OF QUESTIONS THAT MAY BE A GOOD STARTING POINT FOR CONSIDERING WHAT MIGHT BE APPROPRIATE AS KEY INFORMATION. >> I THINK WE SHOULD MAKE THE APPENDIX 1, AND THEN REFERENCE IT IN THE TEXT, IF OTHERS AGREE. ANYONE WANT TO ARGUE AGAINST THAT? >> I WOULD JUST REFERENCE IT AS SOME KEY QUESTIONS, NOT INTENDED TO BE THE COMPREHENSIVE GOLD STANDARD LIST, BUT I THINK IT'S VERY USEFUL. I ALWAYS THOUGHT IT WAS REALLY VERY USEFUL. >> THIS IS NOT THE FINAL FORM. I WAS GETTING THE IDEA DOWN. >> DAVID, PERHAPS WE'LL FINISH THE DISCUSSION OF THIS AND GIVE YOU SOME TIME. DON'T FEEL YOU HAVE TO HAVE IT FINALIZED. >> YEAH. OKAY. OKAY. SO THAT WOULD BE A GOOD ADDITION TO QUESTION 1 AND MAKE USE OF THAT APPENDIX, I'LL GO BACK AND TURN THAT INTO APPENDIX 1 LATER, WE ALL AGREE IT WILL BE. ANYTHING ELSE IN THIS GENERAL RESPONSE TO THESE THREE QUESTIONS? I KNOW WE STRUGGLED TO TAKE IT ANY FURTHER BECAUSE IT WAS A BROAD QUESTION. AND THE GLOBAL WORLD OF RESEARCH MAKES IT REALLY HARD TO COME UP WITH ONE SIZE FITS ALL ANSWERS. QUESTION 2, ADDRESSED AS AN INDIVIDUAL QUESTION, AND THE QUESTION WAS PLEASE CONSIDER WHETHER ELEMENTS OF CONSENT LISTED IN PREAMBLE, THE FIVE LISTED EARLY, SHOULD ALL BE CONSIDERED KEY INFORMATION, OR DEPENDING ON THE DESIGN, CONTEXT, ET CETERA, WOULD SOME NOT BE KEY, ARE THERE ADDITIONAL RECOMMENDATIONS WHAT SHOULD BE CONSIDERED KEY DEPENDING ON DESIGN AND CONTEXT OF THE STUDY, A LONGER ANSWER HERE, THE FIRST PART IS CONSIDERING WHETHER THE ELEMENTS LISTED IN THE PREAMBLE SHOULD BE CONSIDERED TO ENCOMPASS KEY INFORMATION, AND THE REST OF THIS PARAGRAPH LISTS THOSE FIVE. YOU KNOW WHAT THE FIVE ARE. WE GO ON TO SAY WE RECOGNIZE THE ELEMENTS OF CONSENT LISTED MAY OR MAY NOT BE SUFFICIENT. SO WE DON'T REALLY DRAW A HARD LINE THERE TO SATISFY THE REQUIREMENT OF PROVIDING KEY INFORMATION DEPENDING ON THE STUDY. WE DO NOTE FROM A COMPLIANCE PERSPECTIVE SINCE THESE WERE LISTED IN THE PREAMBLE IT'S A GOOD BET THIS IS WHAT THE REGULATORS WOULD EXPECT TO SEE THERE. BUT IT IS THE PREAMBLE, NOT THE RULE. AND AS WE DID EARLIER THE DOCUMENT, WE CONTINUED TO PUSH THE IDEA FLEXIBILITY IS A GOOD THING. AND THAT THERE SHOULD BE THE ABILITY TO STAY FLEXIBLE AND INCLUDING OTHER ELEMENTS OF CONSENT OR EVEN ADDITIONAL INFORMATION THAT IS NOT, YOU KNOW, A REQUIRED ELEMENT OF CONSENT, IF IN THE OPINION OF THE RESEARCHERS AND IRB THAT THAT INFORMATION WOULD BE HELPFUL TO THE REASONABLE PERSON IN MAKING THAT DECISION. AND THAT THERE SHOULD BE FLEXIBILITY TO NOT INCLUDE ONE OF THOSE PREAMBLE ELEMENTS WHEN IT DOESN'T MAKE SENSE. >> I EVEN HATE TO BRING IT UP BUT LINE 152, WHERE IT SAYS" HOWEVER," WE WANT TO DELETE HOWEVER, IT'S NOT IN CONTRAST, JUST SUPPORTING. NOT NECESSARILY SAFE HARBOR, THERE SHOULD BE FLEXIBILITY. >> I SEE A LOT OF HEADS NODDING, I PUT THAT CHANGE IN. OKAY. LET ME CONTINUE ON BECAUSE THEN WE HAVE EXAMPLES OF ADDITIONAL ELEMENTS OF CONSENT OR OTHER INFORMATION THAT MIGHT BE KEY INFORMATION IN CERTAIN STUDIES. AND THIS WAS THE RESULT OF BRAINSTORMING ON THE SUBCOMMITTEES AND AMONGST SACHRP, NOT MEANT TO BE ALL INCLUSIVE BUT THINGS THAT MAY BE OF VALUE FOR INDIVIDUALS ENGAGED IN THE DECISION-MAKING PROCESS. >> DOES BULLET 3 ADD ANYTHING TO BULLET 1? >> NO, IT DOES NOT APPEAR TO, IN MY OPINION. WE CAN -- AND ANY OTHER OBVIOUS BIG TICKET ITEMS THAT MEMBERS OF THE COMMITTEE THINK WE FORGOT OR DIDN'T THINK OF? I WILL SCROLL ALONG, NOT READ THROUGH EACH OF THEM. AND THEN WE -- YEAH? >> [ INAUDIBLE, OFF MIC ] SOMETIMES THERE ARE OTHER OPTIONS. THAT WOULD BE A DESIGN ELEMENT THAT BELONGS IN THE FIRST BULLET. >> SO IT LOOKS SOMETHING LIKE THAT. SO IT'S IN THERE. IS THAT -- DIANA, WOULD THAT WORK? PUTTING IT IN THE FIRST BULLET? >> YES. >> I AM REMINDED BY THE MINUTE TAKER TO PLEASE ASK PEOPLE TO SPEAK INTO THE MIC. YOU'RE RIGHT. THANK YOU. >> ALL RIGHT. I'LL SCROLL ON. SO WE CONCLUDE THIS SECTION BY SAYING REGARDING ITEM 3 OF THE PREAMBLE LIST, REASONABLY FORESEEABLE RISKS OR DISCOMFORT, FREQUENCY OR MAGNITUDE RATHER THAN REASONABLY FORESEEABLE RISKS, AND THE PREAMBLE PUTS THIS IN CONTEXT, AND IT QUOTES WHERE TO FIND THAT IN THE PREAMBLE BUT I DON'T HAVE THE PREAMBLE LANGUAGE IN FRONT OF ME. BUT I THINK THE CONCERN WAS WE DON'T USE KEY INFORMATION AS A NEW DUMPING GROUND FOR RISK AND SUDDENLY IT'S OUT OF PROPORTION WITH EVERYTHING ELSE IN THERE. SO THAT IRB SHOULD BE THINKING ABOUT DISTILLING THAT DOWN, MAYBE BASED ON THINGS LIKE FREQUENCY OR MAGNITUDE. >> YEAH, I THINK ACTUALLY WHAT THE PREAMBLE SAYS THERE IS IT ACTUALLY SAYS MOST IMPORTANT IN THAT OTHER PLACE. >> YEAH, I FORGOT TO LOOK SO I DON'T REMEMBER BUT I'LL TAKE YOUR WORD FOR IT. >> DOES IT MAKES SENSE TO JUST EXPLAIN WHY, YOU KNOW, MAYBE NOT DUMPING GROUND BUT RATHER THAN REASONABLE RISK WHICH WOULD RECREATE WHAT'S ALREADY HAPPENED, A BRIEF EXPLANATION LIKE YOU JUST SAID, DAVID, THAT EXPLAINS WHY WE'RE CONCERNED THAT OTHERWISE PEOPLE WOULD JUST USE THIS TO PUT THE ENTIRE CHART AND LIST OF ALL THE RISKS. >> IT MIGHT BE WORTH CALLING OUT EXPLICITLY HERE THAT THERE IS GOING TO BE A COMPLETE LIST IN THE -- THIS IS NOT THE RISK LIST FOR THE PROTOCOL AND PEOPLE SHOULD USE DISCRETION IN PICKING FROM THAT LIST TO PUT THINGS UP FRONT AND KEY INFORMATION. TO HOPEFULLY HEAD OFF THE IDEA THAT THERE ARE LIABILITY ISSUES AND YOU NEED TO DISCLOSE EVERYTHING. >> OKAY. THIS GIVES ME THE IDEA AND WE CAN FLESH IT OUT. ALL RIGHT. QUESTION 5 WAS ASSUMING RISK AND BENEFIT INFORMATION MUST BE INCLUDED, WHAT CONSIDERATIONS ARE RELEVANT, WHAT STRATEGIES CAN BE USED TO DETERMINE WHICH RISKS AND BENEFITS SHOULD BE INCLUDED AS KEY INFORMATION AND DISCUSSED AS KEY INFORMATION SPECIFICALLY HOW DIFFERENT STUDY DESIGNS, AND, TWO, HOW RISKS AND BENEFITS SHOULD BE DISCUSSED IN KEY INFORMATION. AND SO WE HAVE OUR RESPONSE, THAT STARTS OFF BY SAYING ONE THE MOST IMPORTANT FACTORS IS FREQUENCY AND SEVERITY OF RISKS AND BENEFITS, TYING INTO OUR RESPONSE TO THE PREVIOUS QUESTION. KEY INFORMATION SHOULD NOT INCLUDE FULL LIST OF RISKS AND BENEFITS, FLOODING PEOPLE WITH THE FULL LIST OF RISKS AND BENEFITS DOES NOT AID IN SUBJECT UNDERSTANDING, QUESTION 5 ASKS WHAT CONSIDERATIONS ARE RELEVANT AND WHAT STRATEGIES CAN BE USED TO DETERMINE WHICH SHOULD BE INCLUDED, SACHRP PROVIDES THE FOLLOWING CONSIDERATIONS. IF RISKS OR POTENTIAL BENEFITS ARE SUCH A POTENTIAL SUBJECT WOULD USE THEM MORE, TO DECIDE WHETHER TO PARTICIPATE, MORE LIKELY TO QUALIFY, RISKS WITH GREATEST IMPACT IN TERMS OF FREQUENCY OR SEVERITY WOULD LIKELY MEET THAT CRITERION, THAT AGREE TO WHICH RESEARCH RISKS AND POTENTIAL BENEFITS VARY FROM CLINICAL CARE SUBJECTS ARE RECEIVING OR WILL RECEIVE, HERE WE SAY WILL QUALIFY AS KEY INFORMATION. THIRD BULLET, MANY STUDIES, DISCOMFORT AND INCONVENIENCE RATHER THAN RISK, AVOID EXPOSURE TO SUNLIGHT, YOUR HAIL WILL FALL OUT, REQUIREMENT TO ABSTAIN FROM ALCOHOL OR SEXUAL CONTACT OR HIGH VOLUME OF STUDY VISITS. >> DAVID, CAN YOU GO BACK UP TO QUESTION 3 RIGHT BEFORE THIS? INSTEAD OF -- WHAT WE SAID REGARDING -- CAN WE REFER DOWN, JUST SAY SEE RESPONSE TO QUESTION 5? BECAUSE WE JUST -- WE DISCUSS IT EXHAUSTIVELY, TAKE OUT ALL THE REST OF THAT. >> YEAH. >> SANDY? >> LOOKING AT THE LIST, SCROLLING BACK DOWN TO THE LIST. >> UH-HUH. >> OKAY. WOULD WE WANT TO SAY RISK WITH GREATEST IMPACT AND SEVERITY WITH BE MOST LIKELY, NOT FREQUENCY OR SEVERITY BUT FREQUENCY AND SEVERITY? I MEAN YOU WOULD WANT TO HAVE THE LISTS THAT ARE MOST FREQUENT AND CERTAINLY THE LIST, RISKS MOST SEVERE. >> WOULD BE A BIG CHANGE, WHAT DO COMMITTEE MEMBERS THINK? WHAT ARE THE BENEFITS OF LUMPING THOSE TOGETHER WITH AN "AND" VERSUS SAYING "OR." >> AND/OR. >> NO, I THINK THAT WOULD BE RIGHT ACTUALLY. >> I MEAN, THERE ARE DIFFERENT CRITERIA BUT MAY ALSO BE THE SAME. >> "AND" MAKES IT SOUND LIKE YOU'RE REQUIRING BOTH, YOU DON'T WANT TO SAY ONLY THE ONES THAT HAVE BOTH CHARACTERISTICS. >> RIGHT. YOU DON'T WANT IT TO BE READ AT "EITHER." ALSO, IN THE FOURTH BULLET, ISN'T IT -- IF THERE ARE NO BENEFITS TO THE INDIVIDUALS, IN OTHER WORDS TO THE PARTICIPANTS, BECAUSE THERE'S ALWAYS PUBLIC BENEFIT BUT WE'RE REALLY TALKING ABOUT HERE, NO DIRECT BENEFITS TO THE INDIVIDUAL, IF THERE ARE NO RISKS, DIRECT RISKS? >> YOU DON'T SAY DIRECT RISKS. >> WELL, NO. OKAY. >> DAVID, THIS IS REALLY A SMALL THING, IF YOU SCROLL BACK UP TO ABOVE THE BULLETS, SO IN 198, INCLUDING WHERE THERE ARE NO RISKS AND BENEFITS, I WOULD SAY NO RISKS, NO BENEFITS, WE'RE TALKING ABOUT DIFFERENT THINGS, BUT IT'S VERY SMALL. >> YEP, GOT IT. THAT'S DAVID'S FAULT. HE LEFT THAT OUT. I DON'T KNOW WHAT HE WAS THINKING. IT'S OBVIOUS TO ME. >> BRAIN FREEZE. THE FIRST FOUR WE MADE ADJUSTMENTS, THE LAST DISCOURAGING INCLUSION OF VAGUE STATEMENTS ABOUT RISKS AND BENEFITS, EXAMPLES INCLUDE YOU MAY OR MAY NOT BENEFIT FROM THIS RESEARCH, OR THE RESEARCHERS WILL TRY TO KEEP RISKS AS LOW AS POSSIBLE, THERE MAY BE RISKS WHICH ARE NOT KNOWN AT THIS TIME. WE WANT TO DISCOURAGE INCLUDING THAT AS KEY INFORMATION. >> I MEAN, ISN'T THE LAST ONE POTENTIALLY KEY INFORMATION? I MEAN THERE MAY BE THOSE WHERE THE RISKS ARE UNDERSTOOD BUT MAYBE STUDIES WHERE RISKS ARE NOT KNOWN, THAT IS KEY INFORMATION. >> AS I WAS READING THAT I WAS THINKING FIRST-IN-HUMAN STUDIES, AND IN THAT, YOU KNOW, SAYING THAT KIND OF STUDY MAY BE PART OF THE KEY INFORMATION, WHETHER WE SAY THERE'S SOME RISKS WE OVER THAT ONE. >> [ INAUDIBLE, OFF MIC ] SORT OF COVERING YOUR BASES STATEMENT, RISKS AND BENEFITS ARE NOT FULLY KNOWN AT THIS TIME BUT THERE WAS ALSO -- WE REALLY DON'T KNOW WHAT'S GOING ON HERE, THIS IS A KEY PIECE OF INFORMATION, YOU NEED TO UNDERSTAND. >> YEAH, I MEAN, THAT'S SOMETHING THAT'S IN EVERY CONSENT FORM, BOILERPLATE, DOESN'T REALLY HAVE -- >> SOME OF THESE MICS PICK UP SOUND BETTER THAN OTHERS. >> THAT'S PART OF THE PROBLEM, I HAVE TO LOOK THIS WAY. THAT'S BOILERPLATE IN EVERY CONSENT FORM. IT'S FAIR TO SAY THAT'S NOT KEY INFORMATION BUT WE -- YOU KNOW, WE TALK ELSEWHERE ABOUT THE NEED TO BE MORE DETAILED AND SPECIFIC ABOUT RISKS AND HARM, AND POTENTIAL BENEFITS, SO I THINK IT'S OKAY TO LEAVE THAT IN AS A VAGUE STATEMENT. CERTAINLY IT MIGHT BE SIGNIFICANT BUT TO SAY IT THAT WAY IS NOT SIGNIFICANT. >> MAKING VAGUE STATEMENTS ABOUT VAGUE STATEMENTS. >> YEAH. >> WHAT IF WE SHOULD NOT GENERALLY BE CONSIDERED. YOU KNOW, PEOPLE TAKE THESE THINGS LITERALLY AND SOMEONE WILL LOOK AT THAT AND SAY, WELL, THAT'S NOT KEY INFORMATION. >> OKAY. SO STATING THAT IT'S A FIRST-IN-HUMAN STUDY WOULD BE KEY INFORMATION AND CONVEY THE SAME SENTIMENT I THINK. >> IT MAY NOT CONVEY THE SAME THING BUT WOULD TIE INTO WHAT YOU SAY IN THE RISK SECTION, THE MAIN BODY OF THE CONSENT FORM WHERE A STATEMENT LIKE THAT MAY BE VERY APPROPRIATE IN THAT KIND OF A STUDY. OKAY. I'M GOING TO SCROLL. AND THEN AFTER THE BULLETS WE CONTINUE ON, THE NEXT, HOW SHOULD RISKS AND BENEFITS BE DISCUSSED AS KEY INFORMATION? SACHRP BELIEVES IT'S PREFERABLE TO PLACE INTO A PRO AND CON, OR WHY AND WHY NOT FRAMEWORK WITH POSSIBLE INCLUSION OF ALTERNATIVE TREATMENT TO PROVIDE CONTEXT TO FACILITATE UNDERSTANDING OF RISKS AND BENEFITS PRESENTED AS KEY INFORMATION. IMPLICIT IN CONSIDERATION OF HOW BEST TO PRESENT RISKS OF HARM AND POTENTIAL BENEFITS TO POTENTIAL SUBJECTS IS THE CONCERN THAT PATIENTS WHO ARE POTENTIAL SUBJECTS MAY NOT FULLY APPRECIATE THAT RESEARCH, EVEN RESEARCH THAT HAS SOME POTENTIAL BENEFITS, HAS PRIMARY GOAL OF ADVANCING KNOWLEDGE RATHER THAN DELIVERING TREATMENT, MAY POSE PARTICULAR CHALLENGE, DISTINGUISHED FROM ANTICIPATED VALUE OR SOCIETAL BENEFIT OF THE RESEARCH IN SIMPLE AND STRAIGHTFORWARD TERMS, AND RESEARCHERS SHOULD BE AWARE OF THE POSSIBILITY THAT POTENTIAL SUBJECTS MAY TEND TO OVERSTATE THE VALUE OF THEIR RESEARH, RESEARCHERS MAY TEND TO OVERSTATE VALUE OF RESEARCH AND MINIMIZE RISK OF HARM. >> SO I'M WONDERING WHAT THE OPERATIONAL IMPLICATION OF THAT IS FOR WRITERS OF CONSENT FORMS BECAUSE WE'RE TRYING TO GIVE DIRECTION HERE, AND I DON'T -- I MEAN, I THINK THAT'S TRUE, BUT I THINK -- WE'RE GIVING DIRECTION TO IRBs. BUT I THOUGHT WE WERE GIVING DIRECTION TO WRITERS OF CONSENT FORMS. AND HOW DO I SAY IT TO THE WRITER OF THE CONSENT FORM? >> IN TERMS OF WHO IS THE AUDIENCE FOR THIS DOCUMENT WILL BE, I WOULD THINK THAT INITIALLY IT'S IRBs BUT AS DEPENDING ON HOW IT MAKES IT OUT INTO THE WORLD, IF THERE ARE RESEARCHERS THAT ARE LOOKING FOR GUIDANCE ON APPROACHES TO KEY INFORMATION IT MAY FALL INTO THEIR HANDS AS WELL. I'M NOT SURE HOW I WOULD MODIFY THAT TO MAKE IT MORE NEUTRAL OR BROADLY APPLICABLE. >> I THINK IT'S A TROUBLESOME STATEMENT IN A WAY BECAUSE I MEAN DEALING WITH PEOPLE WHO ARE DECIDING ABOUT RESEARCH, THE DESIRE TO BE -- TO MAKE -- TO ADVANCE KNOWLEDGE AND HELP OTHER PATIENTS IN THE FUTURE AND CURRENTLY IS A BIG SOURCE OF SATISFACTION FOR PEOPLE WHO WANT TO PARTICIPATE IN TRIALS. AND I THINK THAT SHOULD BE A SOURCE OF SATISFACTION FOR THEM. I'M JUST NOT SURE WHAT THAT SENTENCE MEANS OR WHAT OPERATIONAL THINGS ANYONE SHOULD TAKE AWAY FROM IT. >> YEAH, I MEAN -- >> YEAH, THIS IS SOMETHING THAT -- FIRST OF ALL, EVEN THOUGH WE KNOW INVESTIGATORS USUALLY DON'T WRITE THEIR OWN CONSENT FORMS, THAT IS A ROLE THAT THE STUDY TEAM HAS. IT'S NOT THE IRB THAT WRITES THE CONSENT FORM. AND THAT ACTUALLY CAME FROM THE -- FROM SUBCOMMITTEE DISCUSSIONS, TRYING TO GET AT THE FACT THAT IT IS REALLY EASY TO GET CAUGHT UP IN ONE'S OWN RESEARCH AND DESCRIBE IT IN A WAY THAT MAY NOT REALLY DO JUSTICE TO APPROPRIATELY GETTING AT THE HARMS AND BENEFITS, AND SO I MEAN THERE WERE SOME SUBCOMMITTEE MEMBERS WHO FELT REALLY STRONGLY THAT TRYING TO SAY SOMETHING LIKE THIS NICELY WOULD ASSIST WRITERS OF CONSENT FORMS IN STEPPING BACK AND TRYING TO BE -- TRYING TO CRITICALLY REFLECT ON WHAT SUBJECTS SHOULD BE TOLD, EVEN THOUGH THEY WERE ABSOLUTELY CONVINCED THAT THEIR RESEARCH WAS THE GREATEST THING SINCE SLICED BREAD. SO THE IDEA THERE WAS AS PART OF A DISCUSSION OF APPROPRIATELY DESCRIBING HARMS AND BENEFITS AND DISTINGUISHING BETWEEN DIRECT BENEFIT AND BENEFIT TO SOCIETY, THAT IT MADE SENSE TO SAY SOMETHING LIKE EVEN WITH THE BEST INTENTIONS, YOU HAVE TO REALLY THINK ABOUT GETTING THAT RIGHT. THAT'S WHY THAT'S THERE. >> SO WHAT ABOUT SOMETHING THAT SAYS SOMETHING TO THE EFFECT THAT GIVEN THAT KEY INFORMATION IS A SUBSET OF THE RISKS AND BENEFITS THAT WILL BE DESCRIBED LATER IN THE PROTOCOL, IT SHOULD NOT SERVE AS A PLACE -- IT SHOULD NOT REFLECT THE INVESTIGATOR'S NATURAL CONFIDENCE IN THE IMPORTANCE AND BENEFITS OF THEIR OWN RESEARCH OR SOMETHING LIKE THAT. >> HOW ABOUT SOMETHING LIKE DESCRIPTIONS OF SOCIETAL OR DESCRIPTIONS -- HOW DO WE PUT THIS? DESCRIPTIONS OF THE PROJECTS POTENTIAL TO ADVANCE KNOWLEDGE AND HELP PATIENTS SHOULD BE DESCRIBED IN REALISTIC TERMS, OR SOMETHING LIKE -- IN THE PROPER CONTEXT >> THE CONFUSION IS THE TERM "VALUE." I DON'T THINK THIS MEANT TO SAY RESEARCHERS SHOULDN'T SAY THEY THINK THEIR RESEARCH IS GOING TO SOLVE AN IMPORTANT PROBLEM. I THINK THE CONCERN WAS THAT WHAT WAS OVERSTATING DIRECT BENEFIT. >> EXACTLY. >> SO PERHAPS WE CAN RECAST THAT SENTENCE AND NOT TRY TO -- SAYING WHAT THEY SHOULDN'T DO ISN'T REALLY HELPFUL. SO MAYBE IT'S MORE A MATTER OF TAKING THE SENTENCE, RESEARCH SHOULD BE AWARE THEY MAY TEND TO OVERSTATE THE POTENTIAL DIRECT BENEFIT OF THEIR RESEARCH. >> SO WHY -- I'M GOING TO GO BACK TO SANDY'S PERSPECTIVE I THINK. WHY IS THIS AN ISSUE FOR KEY INFORMATION RATHER THAN ISSUE FOR THE WHOLE CONSENT DOCUMENT? >> IT'S AN ISSUE FOR CONSENT DOCUMENT, THAT'S ONE OF THE PROBLEMS HERE, WE SAY THAT SOMEWHERE IS THAT KEY INFORMATION AND SORT OF THE REASONABLE PERSON FOCUS, SORT OF BLEND TOGETHER, AND WE CAN'T JUST WRITE ABOUT KEY INFORMATION WITHOUT WRITING ABOUT SOME OTHER THING SO THAT'S ACTUALLY A DILEMMA IN TRYING TO SEPARATE OUT A GUIDANCE ON KEY INFORMATION FROM A GUIDANCE ON THE CHANGES IN INFORMED CONSENT MORE GENERALLY. >> YEAH, SO I WONDER WHETHER WE SHOULD FIND SOME OTHER PLACE TO PUT IT. I DON'T KNOW. I DO THINK IT STANDS OUT HERE AS NOT BELONGING. >> IT'S A LITTLE OUT OF PLACE. >> AN IMPORTANT POINT BUT I'M NOT SURE THAT IT BELONGS HERE. >> I WOULD JUST -- MY VOTE WOULD BE TO DELETE EVERYTHING ON THE SCREEN STARTING AT 237, RESEARCHERS SHOULD BE AWARE, DELETE THE REST OF THAT PARAGRAPH, AND INSTEAD SAY POTENTIAL DIRECT BENEFITS TO SUBJECTS SHOULD NOT BE OVERSTATED AND SHOULD BE DISTINGUISHED FROM THE ANTICIPATED VALUE. LIKE THE PASSIVE VOICE COULD BE OUR FRIEND HERE BECAUSE WE'RE TALKING -- WE DON'T WANT RESEARCHERS BE ON ANYBODY TO DO, JUST BE ACCURATE AND FACTUAL WHAT WE EXPECT DIRECT BENEFITS TO BE. >> I'M HAPPY WITH THAT. DAVID STRAUSS WON'T BE BECAUSE HE WAS WANTING TO HOLD ONTO THAT IDEA. >> IT'S AN IMPORTANT IDEA. >> [ INAUDIBLE, OFF MIC ]. >> LOOK AT THE NEXT PARAGRAPH. >> ALL RIGHT. SHOULD I DELETE THIS GRAY AREA? OR HOLD IT FOR NOW? OKAY. ADIOS. NEXT PARAGRAPH. WE'RE AWARE SOME IRBs HAVE RESPONDED TO CONCERNS ABOUT POTENTIAL SUBJECTS OVERESTIMATION BY MINIMIZING INFORMATION ABOUT POTENTIAL DIRECT BENEFIT IN THE CONSENT FORM REASONING SUBJECTS WILL BE LESS LIKELY TO BELIEVE THERAPY AND RESEARCH ARE GOVERNED BY THE SAME PRIMARY GOAL. HOWEVER PATIENTS WHO ARE POTENTIAL SUBJECTS APPROACH CLINICAL TRIALS WITH HOPE OF DIRECT BENEFIT, LANGUAGE DOES NOT CORRECT THAT, IT'S ACCEPTABLE AND DESIRABLE TO INCLUDE AN ACCURATE DESCRIPTION OF POTENTIAL BENEFITS TO SUBJECTS. >> THIS WILL BE ANNOYING BECAUSE I REWROTE THE LAST LINE, SO I'M GOING TO READ IT AND SEE IF PEOPLE LIKE IT AND MAYBE I CAN READ IT MORE SLOWLY. AFTER THE SENTENCE THAT SAYS DOES NOT CORRECT THIS MISPERCEPTION, I THINK IT MIGHT BE CLEAR TO SAY POTENTIAL BENEFITS ARE LEGITIMATE CONSIDERATION IN PARTICIPANT'S DECISION TO ENROLL, IT'S ACCEPTABLE AND DESIRABLE TO INCLUDE ACCURATE DESCRIPTION OF POTENTIAL BENEFIT AS KEY INFORMATION, WHEN SUCH BENEFIT IS LIKELY TO BE IMPORTANT TO PARTICIPANT DECISION MAKING. SO IT'S JUST TRYING TO FIRST OF ALL TIE IT TO KEY INFORMATION WHICH IS WHAT WE'RE TRYING TO TALK ABOUT HERE, AND BEING TOTALLY EXPLICIT THAT PEOPLE CAN MAKE THESE DECISIONS, BASED ON EVEN IF IT'S, YOU KNOW, UNLIKELY BUT PLAUSIBLE BENEFIT THAT THAT'S A RELEVANT CONSIDERATION AND BECAUSE IT'S A RELEVANT CONSIDERATION WE SHOULDN'T TAMP IT DOWN, RIGHT? OUR OBLIGATION IN THE CONSENT FORM IS JUST TO PRESENT THE FACTS AS THEY EXIST. SO IF PEOPLE LIKE THAT I CAN READ IT MORE SLOWLY. >> I THINK IT'S A GOOD SENTENCE BUT YOU BURIED THE LEAD, IT OUGHT TO BE THE FIRST, NOT THE LAST SENTENCE OF THE PARAGRAPH. >> SURE. >> WELL, WHY DON'T YOU FINISH THE SENTENCE FOR ME AND WE'LL SEE IF IT OUGHT TO GET PLACED ANYWHERE IN THE PARAGRAPH. >> OKAY. AFTER ENROLL, SEMICOLON, I OVERUSE SEMICOLONS, OR PERIOD. OH SHOOT. SORRY. THERE IT IS, OKAY. DELETE THEREFORE. ACCEPTABLE AND DESIRABLE TO INCLUDE ACCURATE DESCRIPTION, THAT'S ALL THERE. OF POTENTIAL BENEFIT. AN THEN DEETE TO SUBJECTS. AND SAY, AS KEY INFORMATION WHEN SUCH BENEFIT IS LIKELY TO BE IMPORTANT TO PARTICIPANT DECISION MAKING. >> WHY DO YOU NEED THE LAST PHRASE? ISN'T IT ALWAYS GOING TO BE IMPORTANT OR ALMOST ALWAYS GOING TO BE IMPORTANT? WHY NOT END AS KEY INFORMATION. >> SURE, THAT'S FINE. >> ALL RIGHT. SO THIS IS OUR REWRITTEN SENTENCE, AND CAN STAY HERE, IT CAN GO TO THE BEGINNING OF THE PARAGRAPH. >> NO, I DISAGREE WITH MOVING IT. I'LL EXPLAIN WHY. >> GO AHEAD. >> BECAUSE THE IMPORT OF THE PARAGRAPH IN THE FIRST PLACE, AND THIS ACTUALLY CAME FROM DAVID FORSTER, WAS THE IDEA THAT EVERYBODY'S WORRIED ABOUT THERAPEUTIC MISCONCEPTION, AND SO WE DON'T HAVE TO DEFINE AND EXPLAIN IT WE WANTED TO NOT USE THE PHRASE "THERAPEUTIC MISCONCEPTION" IN HERE BUT THAT -- >> SAY IT AGAIN, I DON'T REMEMBER WHY, WE DID NOT INCLUDE IT? >> IT WOULD REQUIRE US TO PROBABLY EXPLAIN AND DEFINE. O IF THE IDEA IS IRBs ARE LEERY ABOUT TALKING ABOUT POTENTIAL DIRECT BENEFIT BECAUSE THEY ARE AFRAID THAT PEOPLE ARE THEN GOING TO AUTOMATICALLY THINK IT'S THEIR TREATMENT, THIS STARTED WITH THE IDEA, OKAY, WE KNOW THAT PEOPLE -- SOME IRBs DON'T WANT THIS TALKED ABOUT AND WE THINK THAT THAT'S WRONG, RATHER THAN FLIPPING IT AND SAYING WE REALLY THINK IT'S IMPORTANT TO START EMPHASIZING DIRECT BENEFIT, IT'S REALLY A RESPONSE TO DOWNPLAYING RATHER THAN A WAY TO TRY TO MAKE IT MORE PROMINENT, SO I THINK THAT THE PROBLEM WITH MOVING THAT SENTENCE TO THE BEGINNING IS THAT IT OVEREMPHASIZES THE ROLE OF DIRECT BENEFIT IN A WAY THAT WASN'T REALLY PART OF WHY WE PUT THE WHOLE PARAGRAPH IN THERE. >> I THINK THAT'S FINE. I WOULD JUST CHANGE THE WORD "ACCURATE" TO SPECIFIC. IT'S OKAY TO PUT IN SPECIFIC LANGUAGE. ACCURATE AND SPECIFIC IS FINE. >> WHAT DO PEOPLE THINK ABOUT TAKING OUT "DESIRABLE"? WE HAVE ALL THIS TALK ABOUT HOW WE CAN'T TELL WHAT SHOULD BE IN THE KEY INFORMATION, IT'S GOING TO VARY, SO -- YEAH. >> EVERYBODY LIKES IT? OKAY. WE'RE NOT DONE WITH QUESTION 5 YET. FINALLY QUESTION 5 ASKS SPECIFICALLY HOW DO DIFFERENT STUDY DESIGNS AFFECT ONE, WHICH RISKS AND BENEFITS SHOULD BE INCLUDED IN KEY INFORMATION AND, TWO, HOW SUCH RISKS AND BENEFITS SHOULD BE DESCRIBED IN THE DISCUSSION OF KEY INFORMATION, AND WE PUNT AND SAY -- WELL, WE REFER BACK TO WHAT WE SAID, AS DISCUSSED ABOVE DIFFERENT STUDY DESIGNS FACTS AFFECT WHICH SHOULD BE INCLUDED AND DESCRIBED, SACHRP DID NOT FIND ANY SINGLE TOOL THAT WAS SUFFICIENT TO IDENTIFY KEY INFORMATION FOR EVERY TYPE OF TRIAL, THAT CONCLUSION APPLIES TO DE-IDENTIFICATION AS KEY INFORMATION AS TARGETED HERE. THERE MAY BE GREAT VARIABILITY IN CHOICE AND PRESENTATION OF KEY INFORMATION. THAT SHOULD BE PRETTY NON-CONTROVERSIAL. OKAY. ALL RIGHT. QUESTION 6, UNDER WHAT CIRCUMSTANCES SHOULD KEY INFORMATION PRESENTED UP FRONT BE REPEATED IN THE CORE SECTIONS OF CONSENT FORM RECOGNIZING THERE IS NO REQUIREMENT THAT ANY SUCH INFORMATION THAT'S ALREADY PRESENTED A THE FRONT OF THE FORM NEEDS TO BE REPEATED, AND HERE IS OUR RESPONSE. THE INTENT OF KEY INFORMATION IS TO CREATE MORE UNDERSTANDABLE CONSENT FORM, NOT SHORTEN OR LENGTHEN, SACHRP SUPPORTS EFFORTS TO DECREASE LENGTH TO THE EXTENT THEY PROMOTE READABILITY AND UNDERSTANDING. HOWEVER SACHRP NOTES THE NEW CONSENT REQUIREMENTS AT SECTION 116 ARE ADDATIVE, THAT AS THE OTHER OPTIONAL ELEMENTS, NONE OF THE CURRENTLY EXISTING ELEMENTS WERE REMOVED. IT'S LIKELY A CONCISE AND FOCUSED PRESENTATION OF KEY INFORMATION WILL ADD TO LENGTH OF THE CONSENT FORM, THAT'S AN OPENING STATEMENT SAYING WE'RE NOT TRYING TO FIX A LENGTH PROBLEM. >> CAN YOU MAKE IT "WILL ALSO ADD." >> DOWN HERE? >> YEAH, EXACTLY. >> ALL RIGHT. THAT'S THE BACKGROUND. WE SAY THEREFORE, SACHRP TAKES THE POSITION INFORMATION PRESENTED IN THE KEY INFORMATION SECTIONS NEED NOT BE REPEATED IN THE SUBSEQUENT SECTIONS OF THE CONSENT DOCUMENT UNLESS THAT INFORMATION IS NECESSARY TO HELP ENSURE THAT THE BODY OF THE CONSENT REMAINED UNDERSTANDABLE TO SUBJECTS CONSISTENT WITH GOALS OF THE REGULATION, IF REPEATING INFORMATION ASSISTS SUBJECT UNDERSTANDING THEN IT SHOULD BE DONE IF THE KEY INFORMATION SUMMARY CONTAINS ALL THE NECESSARY -- ALL THE INFORMATION NECESSARY TO FULFILL A REQUIRED ELEMENT THERE MAY BE NO REASON TO REPEAT, STATED MORE SIMPLY BREVITY SHOULD NOT SACRIFICE CLARITY, MAY FACILITATE MINIMAL REPETITION. >> WHAT ABOUT MAY HELP MINIMIZE REPETITION? MAY FACILITATE MINIMAL, THAT'S SORT OF A -- YEAH. >> IT WILL LOOK LIKE THAT. ACTUALLY THAT DOES READ A LITTLE BIT BETTER. >> THE OTHER THING IS NOT TO MAKE THIS CHANGE NOW BUT WHEN WE FINALIZE THIS DOCUMENT WE SHOULD MAKE SURE ALL OF THE CITATIONS ARE CONSISTENT SO WE DON'T USE THE UNDERSCORE IN SOME PLACES, 46 IN OTHERS. DON'T CHANGE IT NOW. >> TALKING ABOUT THIS? >> YEAH. >> YEAH. ALL RIGHT. THIS SECTION CONCLUDES THE CONSENT FORM MAY BE A FEW PAGES, CONTAINING KEY INFORMATION IN APPROPRIATE FORMAT, SACHRP BELIEVES THIS FLEXIBILITY SHOULD BE ADDRESSED IN AGENCY'S GUIDANCE ON CONCISE CONSENT, READILY AVAILABLE TO THE REGULATED PARTIES. OKAY. THOSE WERE THE FIRST SIX QUESTIONS. >> IN THE INTEREST OF BREVITY, THAT'S THE PURPOSE OF GUIDANCE, DO WE NEED THAT LAST CLAUSE SO IT'S MORE READILY AVAILABLE TO REGULATED PARTIES? >> WE DO NOT. I DON'T THINK WE DO. ALL RIGHT. SO NOW IN THE INTEREST OF LUNCH DO WE KEEP GOING OR. >> [ INAUDIBLE, OFF MIC ]. >> [ INAUDIBLE, OFF MIC ]. >> LET ME LOOK AT THE SCHEDULE. I THINK WE HAVE PLENTY OF TIME. [ INAUDIBLE, OFF MIC ]. >> LET'S TRY TO START AT QUARTER AFTER. RECOGNIZING THAT -- [ INAUDIBLE, >> I WOULD ENTERTAIN A MOTION TO APPROVE LAST MEETING'S MINUTES. >> SO MOVED. >> THE SECOND? IT'S BEEN SECONDED, APPROVED THE MINUTES FROM THE LAST MEETING OF THE DISCUSSION? ALL IN FAVOR SAY AYE. >> AYE. >> OPPOSED? ABSTAINING? MOTION PASSES. THANK YOU. NOW, SLIGHT CHANGE IN PLANS, WE'RE GOING BACK TO MARK BARNES TO FINISH THE DOCUMENT ON THE TRANSITION PROVISIONS BEFORE WE RETURN TO THE MORE LENGTHY DISCUSSION ON KEY INFORMATION. SO, MARK? >> OKAY. SO IN THE INTERIM I HAVE TRIED TO ADD TO THE DOCUMENT AND TRACK CHANGES, THE ISSUES THAT WE DISCUSSED THIS MORNING, AND I'M HOPING THAT I ACCURATELY AND ADEQUATELY REFLECTED THEM. I DID PUT IN EVERYTHING THAT I HAD IN MY NOTES BUT I COULD HAVE FORGOTTEN SOMETHING OR MISSTATED SOMETHING. SO STEPHEN, DO YOU WANT ME TO GO THROUGH -- I SHOULD GO THROUGH BRIEFLY THE DOCUMENT AND SORT OF -- AND THEN HIGHLIGHT THOUGH THOSE THINGS THAT -- THE ACTUAL RECOMMENDATIONS WHICH ARE REALLY BOLD AND UNDERLINED AND ALSO THE CHANGES OR ADDITIONS, OKAY? SO, THIS IS BACK, THE FIRST PART IS BACKGROUND ABOUT THE -- ABOUT WHAT THE TRANSITION PROVISIONS ARE AND ALSO WHAT THE CONSENT -- TRANSITION PROVISIONS ARE THAT SPECIFICALLY APPLY TO CONSENT, TO THE CONSENT ISSUES. THAT'S BASICALLY JUST DESCRIPTIVE, WE HAVE A SECTION ON THE COMPLEXITY WHICH GOES INTO DETAIL ABOUT THE VARIOUS COMPLEXITIES CREATED BY TRANSITION PROVISION, SACHRP BELIEVES A STUDY GRANTED A WAIVER OF INFORMED CONSENT UNDER THE PRE-2018 RULE AND TRANSITIONS TO REVISED COMMON RULE SHOULD CONTINUE TO RELY ON THE EXISTING WAIVER OF INFORMED CONSENT FOLLOWING THE TRANSITION. OKAY. >> I DIDN'T THINK WE HEARD ANY DISAGREEMENT WITH THAT THIS MORNING. >> YEAH, I AGREE. THEN THIS IS IN REGARD -- I GO INTO THE POSTING REQUIREMENT, AND THERE'S A LOT HERE BECAUSE I HAD TO CHANGE A LOT GIVEN OUR DISCUSSION. ONE THING I CHANGED WHICH I NOTED BEFORE IS THAT WE HAVE THREE CATEGORIES. RESEARCH TRANSITIONING TO REVISED COMMON RULE SHOULD COMPLY WITH THE CONSENT FORM POSTING REQUIREMENT, OKAY? IT'S MORE COMPLICATED BUT LET ME GIVE YOU THE FIRST CUT OF THIS. SECOND, IF THE TRIAL ALREADY CLOSED TO RECRUITMENT AT THE TIME THE TRANSITION HAS BEEN MADE, POSTING NO THE LOW THAN 60 DAYS AFTER THE LAST STUDY VISIT OR 60 DATES AFTER TRANSITION DATE WHICH EVER IS LATER THAT'S BECAUSE IT COULD BE THE STUDY IS ONGOING BUT TRANSITION -- LAST STUDY WAS THREE MONTHS AGO BEFORE THE TRANSITION DATE. IF RECRUITMENT IS ONGOING AT THE TIME TRANSITION IS MADE, THE RESEARCHER SHOULD BE REQUIRED TO POST A VERSION OF THE CONSENT FORM THAT IS USED AFTER THE GENERAL COMPLIANCE DATA, REVISED COMMON RULE, SO THE VERSION POSTED REFLECTS ADDITIONAL CONSENT ELEMENTS. AND THERE WAS -- I MADE A MISTAKE ABOUT THE DATE, REVERTED TO 2019. NOW, THEN WE GET TO THE -- I WILL ADMIT THIS IS NOT -- GO AHEAD. >> BEFORE WE MOVE ON, MARK, I THOUGHT IT WAS CLEARER THIS MORNING, SORT OF BACKED OFF, BUT FOR THE BASICALLY THE MIDDLE PART WHERE IF THE TRIAL IS CLOSED TO RECRUITMENT, I'M TRYING TO FIGURE OUT IF THE STUDY HAS TRANSITIONED, IF YOU'RE ALREADY CLOSED BEFORE YOU TRANSITION WOULD YOU HAVE REVISED THE CONSENT FORM, AND IF YOU HAVEN'T, THEN IT DOESN'T MAKE -- IF IT'S THE OLD RULE IT DOESN'T MAKE SENSE TO ME. >> THAT'S TRUE. YEAH, THAT'S TRUE. YOU MEAN, IF ALL THE PATIENTS WERE CONSENTED SO THERE WAS NO REASON TO USE NEW CONSENT FORM. >> RECRUITMENT IS COMPLETE. >> OKAY. >> AND I SUPPOSE, YOU KNOW, AND THEN HOW COMPLICATED DO WE WANT TO GET WITH THE IFS, THEN IF THERE'S ONGOING MONITORING, MAYBE THAT'S WHEN YOU WOULD HAVE TRANSITIONED, BUT -- >> SOMETHING THAT SAYS -- >> IT'S MORE IF YOU HAVEN'T REALLY UPDATED THE CONSENT FORM THEN IT DOESN'T MAKE SENSE. >> SHOULD WE SAY SOMETHING LIKE FOR STUDIES THAT NEVER HAVE A CONSENT FORM THAT'S COMPLIANT WITH THE REGULATIONS, WE DON'T BELIEVE OLD -- PREVIOUSLY COMPLIANT CONSENT FORMS SERVE ANY PURPOSE BY BEING POSTED IN THE SAME REPOSITORY. >> CAN I ASK THOUGH, DOESN'T THIS SENTENCE CAPTURE WHAT YOU'RE TALKING ABOUT? BECAUSE IF RECRUITMENT IS ONGOING -- >> THAT DOES. IT'S THE ONE BEFORE THAT. >> THE ONE BEFORE THAT. THE TRIAL IS ALREADY CLOSED TO RECRUITMENT AT THE TIME OF THE TRANSITION -- >> RIGHT, BUT THE POSTING HERE, THIS IS NOT THE POSTING HAS TO BE REVISED CONSENT POSTING, JUST SAYS IT HAS TO BE POSTED. >> WHICH IS HER POINT. >> I'M QUESTIONING WHAT'S THE VALUE OF THE POSTING A PREVIOUSLY -- >> YOU'RE RIGHT, OKAY. >> I UNDERSTAND IT TO BE LET'S ALL HELP FIGURE OUT HOW WE GO THROUGH THIS PROCESS AND IMPROVE CONSENT FORMS. >> OKAY. SO IF YOU WANT, WE COULD SAY IF THE TRIAL IS ALREADY CLOSED TO RECRUITMENT, POSTING SHOULD BE MADE NO LATER THAN 60 DAYS OR WHICH EVER IS LATER. IF HOWEVER THERE HAS BEEN NO NEED FOR A -- NO REGULATORY NEED OR MANDATE FOR NEW CONSENT FORM THAT COMPLIES WITH THE NEW REQUIREMENTS, THEN NO POSTING SHOULD BE REQUIRED. >> WHAT IF YOU JUST SAY IF THE STUDY HAS NOT USED A CONSENT FORM. >> OKAY. >> BECAUSE PEOPLE MAY VOLUNTARILY COMPLY AHEAD OF TIME AND THERE'S NO REASON NOT TONG POST IT IF THEY ARE UNDER THE NEW RULES. >> I THINK IT COULD JUST BE -- A CHANGE MADE IN THE FIRST SENTENCE, SACHRP BELIEVES RESEARCH TRANSITION SERVED BY COMMON RULE SHOULD BE REQUIRED TO COMPLY WITH POSTING REQUIREMENT IF THE TRANSITIONING RESEARCH USES THE REVISED -- NOT EXACTLY SAYING THE RIGHT LANGUAGE. THE IDEA IF THEY HAVE TRANSITIONED IN SUCH A WAY THEY HAVE CHANGED THE CONSENT FORM. >> BEFORE WE PUT THIS IN, DOES EVERYONE AGREE WITH THIS? OKAY. I THINK WE DID HEAR A SIMILAR SENTIMENT THIS MORNING FROM THE PANEL. >> I THINK WE DID TOO, YEAH. OKAY. HOW'S THAT? OKAY. >> IF WE WANT IT TO BE TOTALLY EXPLICIT WE COULD SAY THERE'S NO NEED TO POST OLD CONSENT FORMS. >> I THINK LESS MAY BE MORE HERE . OKAY. WHAT ABOUT THIS TO MAKE IT EVEN CLEARER, WHAT ABOUT THIS, OKAY? WHAT ABOUT BUT ONLY IF THE TRANSITION STUDY, OKAY? OKAY? >> I DON'T KNOW THAT WE NEED THE SENTENCE AFTER THE YELLOW, RIGHT? >> AFTER THE YELLOW? >> THE LINE 114 IF RECRUITMENT IS ONGOING DO WE NEED THAT? THAT'S WHAT WE'RE SAYING ABOUT NOW. >> YES, YOU'RE RIGHT. >> I THINK WE DON'T NEED IT. IT'S JUST MEANT TO MAKE IT CRYSTAL CLEAR, THAT'S ALL. BUT I'LL TAKE IT OUT IF YOU WANT. THEN I ADDED, ABOUT THE NEXT, I ADMIT THIS IS NOT THE MOST ELEGANT PRESENTATION OR ORGANIZATION OF THIS BUT I'M TRYING TO GET IT IN SO WE CAN GET THIS DONE. I PUT IN THE CONTEXTUAL POINT MADE BY SEVERAL OF THE PANEL SPEAKERS, WHICH IS WHEN A CONSENT FORM IS POSTED, THAT POSTING REGARDLESS OF WHERE IT OCCURS SHOULD INCLUDE SOME CONTEXT FOR THE FORM ITSELF, STUDY NAME, SITE, POINT IN THE LIFE CYCLE WHEN THE POSTED FORM WAS ACTUALLY USED. >> CAN YOU REMIND ME DO WE SAY ABOVE IT DOES NOT HAVE TO BE THE FINAL FORM? BECAUSE THAT'S WHY YOU NEED THIS. >> I THINK WE DO BUT LET ME JUST SEE. œFORM IS NOT REQUIRED TO BENSENT POSTED, RATHER ANY IRB -- OKAY. >> SO, MARK, WHY DID YOU PUT SITES IN THERE? I'M THINKING OF LISTING ON clinicaltrials.gov WHERE OFTEN THE SITES ARE NOT IDENTIFIED. >> ON clinicaltrials.gov THEY ARE ALL SUPPOSED TO BE IDENTIFIED. >> THEY ARE IDENTIFIED IF YOU TAKE PFIZERS AN EXAMPLE, PFIZER INVESTIGATIONAL SITE IN THE STATE, IT WON'T NECESSARILY HAVE THE -- I THINK THAT'S RIGHT. >> NO, NO, IT'S SUPPOSED TO HAVE THE ACTUAL SITE. NOW, THERE ARE A COUPLE PFIZER SITES, I HAPPEN TO KNOW THEY ARE PFIZER-OWNED FACILITIES, IT MIGHT SAY PFIZER FACILITY IN NEW HAVEN BUT IT'S SUPPOSED TO SAY THE ACTUAL SITE. I COULD TAKE OUT THE SITE, THIS IS AN EG, BY THE WAY. >> IF IT'S ON clinicaltrials.gov THAT INFORMATION IS ALREADY SUPPOSED TO BE THERE? >> RIGHT. >> IF IT'S NOT ON clinicaltrials.gov, SO IT DOESN'T MEET THOSE REQUIREMENTS, I DON'T KNOW, I MEAN. >> DOES IT MATTER? OKAY. >> THE KEY THING IS THE WORD IS IN THE LIFE CYCLE. >> OKAY. >> DID WE SAY DATE SPECIFICALLY? DATE AND WHERE IT IS IN THE LIFE CYCLE, SO THAT YOU CAN ACTUALLY SEQUENCE THEM. >> THE APPROVAL DATE OF THE CONSENT FORM? OKAY. >> [ INAUDIBLE, OFF MIC ]. >> NO, THIS IS THE IRB. APPROVAL DATE OF CONSENT FORM SHOULD ALWAYS BE THE IRB, YEAH. >> [ INAUDIBLE, OFF MIC ]. >> YEP, OKAY. OKAY. OKAY. NOW, THEN WE COME INTO THE CHECK THE BOX ISSUE. REMEMBER OUR DERIVATION OF THE CHECK THE BOX PROBLEM CAME FROM THE CONSENT FORM, RIGHT? THIS IS HOW IT WAS PRESENTED TO US. THERE ARE HOWEVER SOME DISTINCT PROBLEMS IN INTERPRETING AND APPLYING POSTING REQUIREMENT, SOME INSTITUTIONS HAVE EXECUTED FWAs WHICH THEY CHECKED THE BOX, THUS APPLYING COMMON RULE REQUIREMENTS REGARDLESS OF SOURCE OF FUNDING. HOWEVER, THE CONSENT FORM POSTING REQUIREMENT INCLUDES DISCRETION TO ALLOW REDACTION TO PROTECT FOR EXAMPLE COMMERCIALLY CONFIDENTIAL INFORMATION. FOR STUDIES NOT FEDERALLY FUNDED BUT INSTITUTION CHECKED THE BOX, THERE IS NO NAMED REGULATORY AUTHORITY, NO NAMED AUTHORITY TO APPROVE REDACTION TO POSTED FORMS. IS EVERYBODY WITH ME ON THAT? OKAY. THIS DEMONSTRATES AMBIGUITY IN COMMON RULE ALLOWING INSTITUTIONS TO APPLY THE COMMON RULE VOLUNTARILY TO ALL OF THE RESEARCH IN WHICH THEY ARE ENGAGED REGARDLESS OF FUNDING SOURCE. IF AN INSTITUTION HAS EXECUTED AN FWA AND CHECKED THE BOX BEFORE COMPLIANCE DATE, BUT THE FWA TERM EXTENTS PAST THE COMPLIANCE DATE, IT IS UNCLEAR AS TO WHETHER THE REGULATORY OBLIGATIONS IN REGARD TO NON-FEDERALLY FUNDED STUDIES WILL EXTEND PAST THE COMPLIANCE DATE. LACK OF NAMED AUTHORITY TO APPROVE REDACTIONS OF POSTED CONSENT FORMS IN A NON-FEDERALLY FUNDED STUDY IS ONE EXAMPLE OF HOW THE REVISED COMMON RULE CANNOT BE FULLY IMPLEMENTED FOR THOSE NON-FEDERALLY FUNDED STUDIES. EVERYBODY WITH ME ON THAT? AT THE SAME TIME IN MARYLAND AND NEW YORK -- IS MEGAN STILL HERE? NO, OKAY. SHE OUGHT TO BE HAPPY ABOUT THIS, WE'LL TELL HER LATER. AT THE SAME TIME IN MARYLAND AND NEW YORK STATE LAWS REQUIRE THAT FOR RESEARCH NOT CONDUCTED UNDER FEDERAL JURISDICTION, ENTITIES AND RESEARCHERS CONDUCTING STUDIES MUST APPLY STATE RESEARCH LAWS. IN THOSE STATES, RESEARCH INTENSIVE INSTITUTIONS HAVE OFTEN CHECKED THE BOX ON THEIR FWAs IN ORDER TO PREVENT APPLICATION OF LESS SALUTARY STATE RESEARCH LAWS. WITH THE ENDING OF THE CHECK THE BOX ALTERNATIVE THOSE IS MAY NOT AVOID OBLIGATIONS, FOR THIS REASON, TAKING INTO ACCOUNT THE NEED TO FREE OTHER INSTITUTIONS FROM COMMON RULE JURISDICTIONS SO THEY ARE NOT REQUIRED TO COMPLY ARE REQUIREMENTS THAT ARE NOT IMPLEMENTABLE, SACHRP RECOMMENDS THE FOLLOWING. INSTITUTIONS THAT CHECKED THE BOX ON THEIR FWAs TO IMPOSE COMMON RULE JURISDICTION SHOULD BE ALLOWED AFTER THE COMPLIANCE DATE TO CHOOSE BY WRITTEN NOTIFICATION TO OHRP WHETHER THEY WISH TO CONTINUE AS A REGULATORY MATTER TO IMPOSE COMMON RULE JURISDICTION ON ALL RESEARCH FOR THE DURATION OF THEIR PREVIOUSLY EXECUTED FWA. OKAY. WHAT, YOU DON'T LIKE THAT? >> WELL, FIRST OF ALL -- >> MIC. >> I'M SORRY. FIRST OF ALL, THERE'S A LOT MORE TO THAT THAN JUST THE INCONVENIENCE OF POSTING. AND SECONDLY THERE'S NO PROVISION IN THE NEW COMMON RULE FOR NOTIFYING OHRP ABOUT WHETHER YOU WANT TO CONTINUE OR NOT. SO IT'S IMPOSING A NEW NOTIFICATION REQUIREMENT THAT PREVIOUSLY HAS NO PARTICULAR REGULATORY WEIGHT BEHIND IT. >> WELL, I MEAN, JUST TO BE CLEAR, THE COMMON RULE TRANSITION PROVISIONS ARE ABSOLUTELY SILENT ON THIS POINT. UNLESS SOMEBODY TELLS ME OTHERWISE. >> WELL, I THOUGHT THEY WERE PHASING OUT THE CHECK THE BOX, AND THAT WAS IN THE COMMON RULE OR AT LEAST IN THE PREAMBLE. >> WELL, THERE'S BEEN AMBIGUITY ABOUT WHAT'S WHAT BUT THE POINT& HERE IS ACTUALLY TO GIVE SOME MORE DISCRETION TO THE REGULATED COMMUNITY WHEN THAT IS NOT INCONSISTENT WITH THE NEW REGULATORY STANDARD. >> THERE'S MORE TO IT THAN JUST POSTING. >> ABSOLUTELY THERE IS. >> THERE'S ISSUES ABOUT AUDITS, THE SCOPE OF AUDITS, OTHER SORTS OF ISSUES. THROWING THIS NOTIFICATION REQUIREMENT OUT IN THE CONTEXT OF THIS RELATIVELY MINOR ISSUE IS NOT REALLY APPROPRIATE. >> OKAY. I MEAN THAT'S FINE. YOU GUYS DECIDE. YOU DECIDE AND I'LL WRITE. >> SCROLL UP. I THINK YOU WERE CAREFUL TO CAST THE CONSENT FORM THING AS AN EXEMPLAR, NOT AS THE DEEP ISSUE. I THINK WE'LL GET TO SOME THINGS ABOUT THE CONSENT FORM SUBMISSIONS LATER BUT I IT DIDN'T SEEM OUT OF PLACE TO ME. SCROLL UP A LITTLE BIT SO WE CAN SEE THE WHOLE THING. WELL, MAYBE WE CAN'T SCROLL UP. COULD YOU MAKE THE SCREEN LONGER? NO, I'M KIDDING. [LAUGHTER] >> SORRY. THERE WE GO. IS THAT BETTER? >> DEMONSTRATE THE AMBIGUITY; THE PARAGRAPH IS GENERAL. NO, THEN IT HAS THE REDACTIONS AGAIN AT THE END. >> THERE ARE TWO REASONS FOR THIS. WE'VE DISCUSSED BOTH, ALTHOUGH ONLY ONE OF THEM I MEAN IN GREAT DETAIL TODAY. ONE REASON IS THE MARYLAND AND NEW YORK PROBLEM. WE MADE A PREVIOUS RECOMMENDATION ABOUT THAT I THINK. I THINK WE DID. BUT IT WAS NOT -- THIS IS NOT INCONSISTENT WITH OUR PREVIOUS RECOMMENDATION. PREVIOUS RECOMMENDATION WAS THAT IT WOULD BE NICE FOR OHRP TO ALLOW THE FWAs TO CONTINUE UNTIL EXPIRATION IN THOSE STATES TO GIVE THOSE INSTITUTIONS A DECENT INTERVAL TO GET THEIR STATE LAWS IN COMPLIANCE. THAT WAS ONE THING. THE SECOND THING IS THE POSTING REQUIREMENT WHICH ILLUSTRATES THE DIFFICULTY IN CONTINUING TO APPLY THE FEDERAL JURISDICTION OVER -- REMEMBER, IT'S NOT AN INSIGNIFICANT PROBLEM. IF YOU CHECK THE BOX, AND YOUR FWA EXTENDS PAST COMPLIANCE DATE FOR ALL THE STUDIES THE INDUSTRY-SPONSORED STUDIES, ALL THE STUDIES NOT FEDERALLY FUNDED, YOU'RE GOING TO HAVE TO POST. THAT'S NOT AN INSIGNIFICANT OBLIGATION, ESPECIALLY GIVEN COMMERCIALLY SPONSORED STUDIES, YOU'LL RUN INTO ALL THE REDACTION PROBLEMS. >> SO WHAT WE'RE DOING HERE, WE'VE ALREADY IN PREVIOUS RECOMMENDATIONS SAID YOU SHOULD BE ABLE TO EXTEND YOUR CHECK THE BOX BECAUSE OF THE STATE LAW ISSUE. >> RIGHT. >> NOW WE'RE SAYING THAT FOR THOSE WHO DON'T WANT TO EXTEND THE BOX, CHECK THE BOX, SINCE THE REGULATIONS SIG SIGNAL IN THE PREAMBLE THIS IS NOT THE WAY OHRP IS GOING YOU CAN WITHDRAW YOUR BOX WITHOUT HAVING TO SUBMIT YOUR FWA, THEN WE'LL GET INTO THE CASE YOU DON'T HAVE MUCH CHOICE BECAUSE OF STATE LAW ISSUES BUT YOU'RE CONFRONTED WITH CONSENT FORM. >> POSTINGPROBLEM. >> THAT'S THE ISSUE WE IDENTIFIED TODAY. >> RIGHT. >> SO DON'T INSTITUTIONS -- I GUESS MY INTERPRETATION WAS THAT WITH THE NEW REVISED COMMON RULE WHATEVER YOU CHECKED IN THE BOX IS NO LONGER RELEVANT BECAUSE YOU -- THEY ARE ELIMINATING THIS REQUIREMENT, PROVISION, THAT WAS MY ASSUMPTION BASED ON THE LANGUAGE, BUT THAT INSTITUTIONS WHO WANTED TO APPLY THE SAME RULES TO EVERYTHING COULD CONTINUE TO DO SO AND THEY MIGHT DO THAT BECAUSE THEY PREFER TO DO IT, SIMPLER FOR THEM, NOT TO HAVE TWO SETS OF BOOKS, OR THEY MAY DO IT BECAUSE THEIR STATE LAWS REQUIRE THEY DO THAT, BUT THEY DON'T HAVE TO SUBMIT PAPERWORK ABOUT IT. IT'S SIMPLY THERE. AND IT WORRIES ME TO CREATE SOME SORT OF NOTIFICATION REQUIREMENT IN RELATION TO THIS RELATIVELY TINY ISSUE ABOUT WHETHER YOU HAVE TO POST A CONSENT FORM AFTER -- IF YOU HAVE GONE THROUGH A PARTIAL TRANSITION, THAT'S SORT OF LIKE A FLEA ON THE TAIL WAGGING THE DOG. >> COMMON SENSE BUT MY INTERPRETATION, I'LL ASK MARK TO VERIFY, YOU'RE NOT COMPLIANT WITH STATE LAW BECAUSE YOU SAY OUR POLICY IS TO FOLLOW THE COMMON RULE. HAVE YOU TO BE ABLE TO BE HELD TO THAT. >> RIGHT. >> THAT'S WHY THE CHECKING OF THE BOX IS IMPORTANT. IT PUTS YOU UNDER THAT JURISDICTION, NOT AS A MATTER OF VOLUNTARY POLICY BUT PEOPLE CAN TAKE COMPLIANCE ISSUES AGAINST YOU. THAT'S MY UNDERSTANDING, KEEPING THE BOX IN PLACE. >> IF YOU'RE NOT UNDER STATE LAW, YOU CAN STILL CONTINUE THE POLICY OF APPLYING THE SAME THING. >> ABSOLUTELY. THEY WOULDN'T HAVE -- >> IF YOU'RE UNDER STATE LAW YOU HAVE TO SAY YOU'RE REQUIRED DO THIS. >> THAT'S RIGHT. >> THAT IS CORRECT, YEAH. >> ACCORDING TO FEDERAL OR STATE LAW? >> STATE LAW, YEAH. YOU HAVE TO DEMONSTRATE UNDER BOTH STATE LAWS THAT YOU ACTUALLY ARE LEGALLY OBLIGATED TO COMPLY WITH THE FEDERAL STANDARDS. >> WHILE WE'RE TALKING ABOUT STATE LAWS, WHICH IS NOT GETTING TO THE SUBSTANTIVE POINT WE'RE TALKING ABOUT NOW, THE PARAGRAPH THAT YOU'VE ADDED HERE, I WOULD SUGGEST THAT LIKE MARYLAND, FOR EXAMPLE, SAYS YOU HAVE TO FOLLOW THE FEDERAL, SO IT'S NOT LESS -- CHARACTERIZATION OF THEM LESS PROTECTIVE OR LESS CLEAR? >> IS NOT TRUE. >> IS NOT ACTUALLY TRUE. >> OKAY, OKAY. >> AND SO, YOU KNOW, WE ARE SORT OF LEAVING OFF -- I THINK IT MAY BE HELPFUL HERE TO NOT JUST SAY MARYLAND AND NEW YORK BUT TO SAY SOME STATES LIKE MARYLAND AND NEW YORK. I DON'T HAVE VIRGINIA IN FRONT OF ME. I DO RECALL IN TERMS OF -- >> THERE IS, YEAH. >> WE CAN AVOID THAT PROBLEM BUT DESCRIBE GENERALLY THAT THERE ARE REQUIREMENTS AND HOW THIS PLAYS OUT WITHOUT CHARACTERIZING THEM AS MORE OR LESS PROTECTIVE. >> HOW'S THAT? HOW'S THAT? YEAH, NANCY? >> JUST ONE OTHER THING. I WOULD -- MAYBE WE SHOULD DELETE LESS SALUTARY FROM LINE 4, YOU DON'T WANT TO NECESSARILY DIS MARYLAND AND NEW YORK FOR HAVING STATE RESEARCH LAWS. >> LET ME -- YEAH, OKAY. >> THERE'S NO NEED TO MODIFY. >> OKAY. >> WITH AN ADJECTIVE THAT MIGHT OFFEND THE LEGISLATORS. >> OKAY. >> CAN YOU MAKE IT BIGGER AGAIN? >> OKAY. IS THAT BETTER? I LOST THE LINE NUMBERS. I DON'T KNOW HOW THAT HAPPENED. JULIA, IF YOU WANT TO GET THEM BACK YOU'RE WELCOME TO COME UP HERE AND GET THEM BACK, OR IF DAVID KNOWS HOW TO DO IT. >> I THINK YOU JUST CHANGE THE -- >> OH, THANK YOU. OKAY. >> IF YOU WANT TO JUST BE CONSISTENT THEN USE OF STATES OTHER THAN NAMING MARYLAND AND NEW YORK, WHICH -- >> WHAT ABOUT THIS. HOW ABOUT THAT? OKAY? NOW, SO BUT THERE'S STILL RESIDUAL PROBLEM WHICH IS MARYLAND AND NEW YORK, PERHAPS IN VIRGINIA, THEY ARE GOING TO WANT TO CONTINUE -- THEY ARE GOING TO NOTIFY OHRP IF OHRP IMPLEMENTS THEY WANT TO CONTINUE THEIR FWA APPLYING TO ALL OF THEIR RESEARCH. SO THEN THEY HAVE STILL GOT THE PROBLEM THAT THEY HAVE RESEARCH AND THEY'VE GOT TO POST ALL THESE FORMS BUT THEY HAVE NO AUTHORITY, THERE'S NO AUTHORITY TO WHICH THEY CAN APPEAL, SO THEY CAN POST THE WHOLE FORM BUT THE INDUSTRY SPONSORS AS YOU'VE HEARD ARE NOT GOING TO WANT THEM TO DO THAT. SO I'LL GIVE YOU WHAT MY ITERATION, YOU CAN CHOOSE WHATEVER YOU WANT. FOR MARYLAND AND NEW YORK ENTITIES THIS CHOICE TO CONTINUE PAST COMPLIANCE DATE WILL THEREFORE MEAN THEY WILL BE SUBJECT TO THE CONSENT FORM POSTING REQUIREMENT EVEN THOUGH THERE'S NO AUTHORITY TO WHICH TO APPEAL FOR REDACTION PERMISSIONS. BECAUSE THIS NEW COMMON RULE REQUIREMENT CANNOT MEANINGFULLY BE IMPLEMENTED IN THIS CONTEXT, SACHRP SUGGESTS ... NOT ENFORCING POSTING REQUIREMENT EXCEPT IN FEDERAL FUNDED STUDIES. >> TAKE OUT THEN, IN FRONT OF THEN SACHRP, BECAUSE THE COMMON RULE REQUIREMENT, YEAH. BUT I THINK THIS IS GOOD. IT ACTUALLY HIGHLIGHTS ANOTHER UNINTENDED CONSEQUENCE, BECAUSE THOSE OF COURSE ARE THE STUDIES THAT MOST NEED REDACTION. AND IF SPONSORS ARE FACED WITH -- >> THAT'S TRUE. >> THERE MAY BE LESS RESEARCH THAT'S DONE IN MARYLAND AND NEW YORK. >> A TIME POINT, EVEN THOUGH THERE'S NO AUTHORITY TO WHICH TO APPEAL PROBABLY SAY NO FUNDING AUTHORITY BECAUSE IF YOU LOOK AT THAT PARAGRAPH YOU THINK WHY COULDN'T THE IRB DECIDE WHAT IS REDACTABLE. >> OKAY. >> THAT'S NOT WHAT THE REGULATION REFERS TO. >> OKAY, GREAT. HOW'S THAT? >> AT THE BEGINNING, I'M NOT SURE WE HAVE TO CALL OUT NEW YORK OR MARYLAND, BECAUSE WE HAVE -- WE'VE SAID BEFORE THAT SOMEBODY WITH AN EXISTING FWA MAY MAKE THE DECISION, WE'RE NOT SURE WHY BUT JUST FOR THOSE ENTITIES THAT CHOOSE TO EXTENT THEIR FWA OR CONTINUE TO APPLY THE COMMON RULE, THEN WE DON'T CALL OUT NEW YORK AND MARYLAND AGAIN. >> OKAY. I TOOK IT OUT. YOU CAN SEE. OKAY. AND THEN I DROPPED A FOOTNOTE HERE BECAUSE OF SOMETHING THAT MEGAN HAD SAID, AND THE FOOTNOTE IS 23, LET ME FIND OUT WHERE IS 23 UP HERE. DID I PASS IT? OH, HERE IT IS. YEAH, YEAH, OKAY. SO FOOTNOTE 23, SACHRP NOTES IN MARYLAND AND NEW YORK INSTITUTIONS THAT ELECT TO -- THAT IN STATES -- THAT INSTITUTIONS THAT ELECT TO CONTINUE TO SELF IMPOSE COMMON RULE JURISDICTION OVER ALL THEIR RESEARCH ALSO WILL BE CONDUCTING SOME RESEARCH UNDER FWA JURISDICTION, UNDER COMMON RULE JURISDICTION AS WELL, BECAUSE THEY ARE STILL ADHERING TO COMMON RULE FOR EVERYTHING, FOR THOSE STUDIES UNDER BOTH REGULATORY REGIMES INDUSTRY SPONSORS MUST TOLERATE CONSENT FORMS THAT COMPLY WITH NEW COMMON RULE CONSENT REQUIREMENTS. THIS IS MEGAN'S POINT. I ASKED HER ABOUT IT IN THE BREAK. HER POINT WAS BASICALLY THIS. THAT BECAUSE WE SELF IMPOSE ALL FEDERAL REQUIREMENTS WE CANNOT COMPROMISE WITH SPONSORS NOT TO USE THE REVISED CONSENT FORM. THAT'S THE POINT. OKAY? >> IS THE LANGUAGE THAT YOU WANT THAT INSTITUTIONS SELF IMPOSE TO CONTINUE, SELF IMPOSE THE COMMON RULE, IT'S THAT STATE LAW REQUIRES THAT THEY CONTINUE TO APPLY THE FEDERAL COMMON RULE, THEY ARE NOT SELF IMPOSING IT. THEY ARE IN STATES WHERE THE STATE LAW REQUIRES. THEY ARE NOT ELECTING TO DO THAT. THEY ARE REQUIRED TO DO IT BY STATE LAW INSTEAD OF FEDERAL LAW. >> WELL, IN MARYLAND AS I UNDERSTAND IT'S REQUIRED -- THEY ARE REQUIRED TO COMPLY WITH FEDERAL LAW, BUT IN NEW YORK THEY ARE NOT REQUIRED TO COMPLY WITH FEDERAL LAW BUT IF THEY DON'T COMPLY WITH FEDERAL LAW THEN STATE LAW APPLIES. SO THEY ARE NOT ACTUALLY REQUIRED TO COMPLY WITH FEDERAL LAW IN NEW YORK. >> OKAY. FORTUNATELY CALIFORNIA HASN'T DONE THAT YET. IF THEY HEARD ABOUT IT, THEY WOULD. >> OKAY. LINE 187 OR SO THE ISSUE WHEN A STUDY TRANSITIONS DO SUBJECTS WHO ARE CONSENTED UNDER THE OLD COMMON RULE REQUIREMENTS NEED TO BE RECONSENTED UNDER THE NEW AND THE ANSWER IS NO. WE TALKED ABOUT THAT, RIGHT? >> [ INAUDIBLE, OFF MIC ]. >> IT MEANS THE FOLLOWING. IT MEANS THAT IF AN INSTITUTION STILL HAS AN FWA, WHETHER IT'S IN NEW YORK, VIRGINIA, OR MARYLAND OR ANYWHERE ELSE, BUT IT CONTINUES TO SELF IMPOSE THE FWA REQUIREMENT, IF IT CONTINUES TO CHECK THE BOX SO THAT ALL THE RESEARCH DONE IN THAT SPONSOR MUST BE COMPLIANT WITH THE REVISED COMMON RULE AFTER THE COMPLIANCE DATE, THIS MEANS THAT THOSE INSTITUTIONS HAVE NO CHOICE BUT IN ALL OF THEIR RESEARCH TO HAVE CONSENT FORMS THAT COMPLY WITH THE NEW REVISED COMMON RULE WITH THE CONCISE STATEMENT AND ALL THE OTHER THINGS. SO IN THOSE SITUATIONS IT'S NOT REALLY -- IT'S NOT LEGALLY POSSIBLE FOR THE SPONSOR TO INSIST ON THE SITE, NOT HAVING A CONSENT FORM THAT AT LEAST COMPLIES WITH THE NEW FEDERAL REQUIREMENTS. >> [ INAUDIBLE, OFF MIC ]. >> OKAY. >> OR JUST BE WILLING TO ACCEPT. >> RIGHT. >> RIGHT. >> HOW'S THAT? >> [ INAUDIBLE, OFF MIC ]. >> YES, UH-HUH. WELL, THE REASON ABOUT SPONSORS IS BECAUSE THAT'S WHAT MEGAN WAS SAYING WHERE THE RUBBER IS GOING TO MEET THE ROAD WHICH IS IT'S GOING TO BE SPONSORS WHO SAY, ESPECIALLY FRANKLY SMALL DEVICE COMPANIES ARE GOING TO SAY WE DON'T WANT THIS. WHERE IS THIS CONCISE STATEMENT COMING IN? WE DON'T LIKE THIS. WE DON'T WANT THIS. BUT THE INSTITUTION HAS NO CHOICE BUT TO USE THE NEWLY COMPLIANT CONSENT FORM. OKAY. >> WHAT IF YOU TOOK OUT INDUSTRY AND PUT SPONSORS? >> OKAY. HOW'S THAT? OKAY. >> [ INAUDIBLE, OFF MIC ]. >> I'M SORRY. >> IT SAYS -- WHY NOT JUST SPONSORS ACCEPT. >> OKAY, OKAY. NOW, THE NEXT POINT IS THIS -- WAS TO ENCAPSULATE THE LONG DISCUSSION WE HAD ABOUT WHAT HAPPENS WHEN A STUDY THAT HAS TRANSITIONED HAS SOME PEOPLE WHO ARE CONSENTED UNDER THE OLD FORM, SOME WHO AFTER THE TRANSITION DATE WERE CONSENTED UNDER THE NEW FORM BUT ALL OF A SUDDEN THE IRBs WANTS RECONSENT FOR EVERYONE, WHEN THE PEOPLE THAT CONSENTED UNDER THE OLD FORM HAVE TO GET THE NEW FORM WITH THE NEW INFORMATION ABOUT RISK OR BENEFIT, OR DO THEY GET THE OLD FORM WITH THE NEW ESSENTIAL INFORMATION ADDED TO THE OLD FORM THAT THEY ALREADY SAW? AND REMEMBER AFTER THAT LONG DISCUSSION WHAT WE SAID WAS THE IRB SHOULD BE ABLE TO CHOOSE IN THOSE SITUATIONS ONE OF THREE ALTERNATIVES. ONE IS THEY CAN MANDATE RECONSENT, USING THE NEW CONSENT FORM COMPLIANT WITH REVISED COMMON RULE. OR MANDATE RECONSENT USING PRE-COMPLIANCE STATE FORM AMENDED WITH REQUISITE INFORMATION OR MANDATE SUPPLEMENTAL FORM TO PRESENT AND HIGHLIGHT NEW INFORMATION ALONE. >> CAN YOU SCROLL BACK DOWN? I THINK THE LANGUAGE -- NO, THE OTHER WAY, SORRY. THE LANGUAGE AT A POINT, OTHER STUDIES WHICH AN IRB MAY REQUIRE AT A POINT FOLLOWING THE COMPLIANCE DATE ALL SUBJECTS -- I WOULD SAY ALL SUBJECTS BE GIVEN OPPORTUNITY TO RECONSENT. I DON'T THINK -- YEAH, AS TO RECONSENT OR AS TO REAFFIRM THEIR CONSENT TO PARTICIPATE SINCE I'M NOT SURE RECONSENT IS REALLY A THING. THANK YOU. >> HOW'S THAT? NANCY'S CRINGING. SHE DOESN'T LIKE RECONSENT TO BE USED AS A VERB LIKE THAT. BUT ANYWAY. OKAY. >> A TYPO IN 201, IRB SHOULD HAVE BROAD DISCUSSION AS TO. >> OKAY. >> IF YOU DON'T USE ITS A VERB, IT'S NOT A NOUN. >> NOT A TRANSITIVE VERB. >> OKAY. >> [ INAUDIBLE, OFF MIC ]. >> AND THEN WE SAY AT THE BOTTOM IN TERMS OF RATIONALE THE IRB DECISION SHOULD BE MADE ... LEAST CONFUSING FROM THE SUBJECT'S POINT OF VIEW, OKAY. OKAY, THEN THERE'S SORT OF THIS OVERARCHING RECOMMENDATION THAT BASICALLY SAYS TURN BACK BEFORE IT'S TOO LATE AND DON'T TRANSITION UNTIL YOU ARE FORCED TO DO SO. BUT THEN THERE WAS THE -- THEN HEATHER SAID OR SOMEBODY SAID THERE'S INSTITUTIONS THAT HAVE GONE DOWN THAT ROAD AND CAN'T TURN BACK NOW. WHAT ARE WE TELLING THEM, WE DON'T WANT TO MAKE THEM TOO NERVOUS, I ADDED SOME INSTITUTIONS HAVE BEGUN TO TRANSITION TO STANDARDS OF THE REVISED COMMON RULE, AND FOR THOSE INSTITUTIONS IT IS IMPORTANT THEY UNDERSTAND AS CLEARLY AND PRACTICALLY AS POSSIBLE HOW TO IMPLEMENT THAT TRANSITION WHICH MAY INCLUDE TOLERATING MORE REGULATORY AMBIGUITY THAN THEY HAVE BEEN ACCUSTOMED AND WITH WHICH THEY HAVE BEEN COMFORTABLE. FOR THOSE ENTITIES IRBs AND RESEARCHERS THAT TRANSITION STUDIES BEFORE LEGALLY REQUIRED TO DO SO WE DISCUSS IN THIS LETTER ADDITIONAL GUIDANCE THAT SACHRP RECOMMENDS CONSISTENT WITH THE ISSUES IDENTIFIED ABOVE. >> I THINK YOU SHOULD SAY THEY MUST TOLERATE. NO, I'M KIDDING. [LAUGHTER] SO, IS HEATHER STILL HERE? >> YES. >> THERE SHE IS. >> HEATHER, WHEN YOU TALK ABOUT INSTITUTIONS THAT HAVE STARTED TO TRANSITION, WHAT THEY HAVE STARTED TO DO IS ADOPT THESE NEW CONSENT REQUIREMENTS, BUT SORT OF STATUTORY TRANSITION THEY COULD STILL NOT DO THAT. >> YES. [ INAUDIBLE, OFF MIC ] I THINK THE INSTITUTIONS -- IT'S NOT -- AT THE LEAST FROM OUR MEMBERSHIP FROM LARGE INSTITUTIONS A HUGE NUMBER, BUT IT'S INSTITUTIONS WHO HAVE DECIDED WE'RE GOING TO JUST MOVE EVERYTHING. WE'RE GOING TO HAVE ONE SET OF POLICIES, SO IF IT WAS ONGOING WE'LL TRANSITION ALL THOSE STUDIES, AND ALL NEW STUDIES AND TREAT THEM ALL THE SAME WAY. AND AGAIN IT'S CERTAINLY NOT A MAJORITY. BUT IT IS WORTH, AS I THINK MEGAN SAID, THROWIG A BONE TO THOSE, THAT SAYS YOU HAVEN'T MESSED UP, YOU JUST DON'T HAVE TO DO IT THIS WAY. >> ANOTHER ALTERNATIVE FOR THOSE STUDIES FOR WHICH THIS APPLIES, THERE'S CONSENTING GOING ON AND EVERYTHING ELSE, THEY ARE NOT LIKELY TO BE STUDIES THAT HAVE ANY BURDEN-REDUCING ADVANTAGES TO TRANSITIONING. THEY ARE CONSENTING, THEY ARE STILL GOING TO BE DOING CONTINUING REVIEWS AND EVERYTHING ELSE. THEY COULD DO ALL OF THE THINGS THAT THEY PLANNED TO DO ON THE SAME I.T. SYSTEM AND NOT DECLARE THE STUDY HAS TRANSITIONED AND AVOID THIS STUFF. >> YEAH, THAT'S SOMETHING YOU COULD PUT IN THERE IF YOU HAVEN'T MADE A FORMAL DECLARATION. IS THE PROCESS FOR DECLARING WELL LAID OUT? >> I THINK IT HAS TO GO THROUGH THE IRB BUT I THINK IT HAS TO BE IN THE IRB RECORDS. >> INTERNAL DOCUMENTATION. >> I THINK IF YOU HAVEN'T MADE THAT DETERMINATION YOU CAN STILL MOVE FORWARD. >> THEY CAN'T HAVE MADE THAT, WELL, UNLESS THEY TOOK ADVANTAGE. >> RIGHT, EXACTLY. >> SO, HEATHER, I MEAN IS THIS OKAY WITH YOU, THIS NEW LANGUAGE? >> I DON'T THINK THE LANGUAGE IS PROBLEMATIC. I DON'T KNOW THAT IT GIVES MUCH PRACTICAL GUIDANCE. [ INAUDIBLE, OFF MIC ]. >> MARK, I THINK WE SHOULD DELETE THE CLAUSE, 223, WHICH MAY INCLUDE TOLERATING AMBIGUITY. I DON'T THINK WE NEED IT. >> TELL THEM THEY HAVE GONE DOWN THE WRONG ROAD. [LAUGHTER] >> TO EXTENT THIS IS ABOUT WHICH ROAD DO YOU GO DOWN I WAS WONDERING WHETHER IT SHOULD BE AT THE VERY BEGINNING OF THE DOCUMENT, RIGHT? BECAUSE I DON'T KNOW, IF YOU DECIDED NOT TO DO THESE THINGS MAYBE YOU DON'T CARE ABOUT THE REST OF THE DOCUMENT. >> THERE'S STILL A LOT IN THIS DOCUMENT YOU CARE ABOUT REGARDs WILL OF WHICH ROAD YOU TOOK BECAUSE OF THE FWA ISSUE AND OTHER THINGS. >> HOLLY LET'S GO THROUGH AND WE'LL SEE. >> THAT'S FINE. >> OKAY. THERE ARE A COUPLE CHANGES HERE THAT I MADE. THIS WAS CONVERSATION I HAD WITH NANCY. >> MARK, GO BACK, YEAH, RIGHT THERE ON 237. >> YEAH. >> ACCORDING TO THE REVISED COMMON RULE THIS IS THE POINT MADE EARLIER THAT ACCORDING TO THE PREAMBLE OF THE REVISED COMMON RULE. >> YEP. >> YEP, PERFECT. >> OKAY. AND THIS IS THE BACKGROUND ABOUT THE 21ST CENTURY CURES ACT AND THE STATEMENT THAT'S REQUIRED ON THE 13th, BY THE 13th OF DECEMBER OF 2018. THE FDA, IT'S NOT -- WE HAD SOME CONVERSATIONS WITH OURSELVES ABOUT THIS HARMONIZATION MANDATE, AND IT'S NOT CLEAR THAT -- IT'S NOT CLEAR UNDER HARMONIZATION THAT IT DOES REQUIRE THE FDA ADOPT COMMON RULE REQUIREMENTS, JUST THEY HAVE TO BE HARMONIZED WHICH MEANS THEY DON'T HAVE TO BE INCONSISTENT. SO I WAS GLAD THAT WE ACTUALLY WROTE THIS WITHOUT HAVING SEEN THE FDA ISSUANCE LAST WEEK, AND THE FDA WAS SO WONDERFUL, I MEAN, PEOPLE KNOW THE FDA WAS SO INTENT ON NOT BREACHING ANY OBLIGATION THAT WE HAD NO IDEA THAT WAS COMING OUT, AND IT WAS A COMPLETE HAPPY HAPPENSTANCE THAT THIS DRAFT WAS COMPLETELY CONSISTENT WITH THE FDA GUIDANCE DOCUMENT. THAT'S THE TRUTH. RIGHT? ANYWAY, SO, OKAY. WE TALK ABOUT THE CO-TERMINUS JURISDICTION OF FDA AND COMMON RULE. AND THEN THIS IS THE POINT AT WHICH WE TALK ABOUT THE KIND OF BATTLE OF THE FORMS ISSUE AND INDUSTRY WANTING FDA AND REQUIREMENTS, NOT MORE, SOME CASES, INSTITUTIONS WANTING AND EXPECTING NEW COMMON RULE REQUIREMENTS WOULD BE MET. WE CONTEMPLATE SOME SPONSORS, WE HEARD FROM PFIZER THEY HAVE BEGUN TO IMPLEMENT THESE NEW REQUIREMENTS ALREADY, EVEN THOUGH NOT REQUIRED TO DO SO BY ANY FDA REGULATION. AND THEN WE PUT -- WE HAVE THIS GENERAL LANGUAGE WHICH I THINK ACCURATELY REFLECTS WHAT THE CONVERSATION HAS BEEN, AT LEAST THE SUBCOMMITTEES, EXPRESSED TODAY, THAT THESE INSTITUTIONS, COMPANIES, PEOPLE, RESEARCHERS, IN SO FAR AS POSSIBLE TO TOLERATE THE DIFFERENCES AMONG ONE ANOTHER, AS LONG AS THE BASIC LEGAL REQUIREMENTS ARE MET IN THESE STUDIES FOR INFORMED CONSENT. AND THIS IS THE BASIC, TO PREVENT DEADLOCK, RESEARCH, BELIEVE IT ESSENTIAL THAT ALL PARTIES INSIST DURING TRANSITION ON CONSENT FORM COMPLIANCE WITH TRUE ACTUAL REGULATORY OBLIGATIONS AND YET PARTIES TOLERATE WHEN POSSIBLE OTHER PARTIES' EFFORTS TO IMPROVE CONSENT FORMS AND PROCESSES CONSISTENT WITH REVISED COMMON RULE. NOW, THEN WE COME TO -- I TRIED TO INSERT HERE THE POINT THAT SEVERAL PEOPLE MADE TOWARD THE END OF THE DISCUSSION, I THINK MAYBE A.J. HAD MADE, WHICH IS THAT GIVEN THE AMBIGUITY IN THESE TRANSITION PROVISIONS, EVEN AMBIGUITY IN REGULATIONS, EVEN AFTER TRANSITION, THIS IS THE RECOMMENDATION BASICALLY SAYS THAT SACHRP IS RECOMMENDING THAT OHRP AND LATER AFTER IT ADOPT'S ITS VERSION FDA BASICALLY TRIED TO TOLERATE DIFFERENT INTERPRETATIONS OF THESE REGULATIONS SO THAT THE REGULATED COMMUNITY HAS AN OPPORTUNITY TO TRY TO CONFORM PRACTICES TO BEST PRACTICES, AND THEN WE CAN ALL LEARN FROM THAT. THIS IS THE POINT THAT STEPHEN MADE. >> SO, MARK, I DON'T THINK IT'S ENFORCEMENT DISCRETION BECAUSE YOU'RE NOT TAKING THINGS OUT OF COMPLIANCE. I WOULD TAKE THAT THING THAT STARTS WITH IF, 422, TAKE THAT WHOLE FIRST SECTION OUT UP TO "THE," START WITH CREATIVITY OF REGULATED COMMUNITY. IF I'M RIGHT ABOUT ENFORCEMENT DISCRETION, IT DOESN'T SEEM QUITE THE RIGHT CONCEPT. >> OKAY. DO YOU WANT ME TO READ THIS OR PEOPLE CAN READ IT TO THEMSELVES? NO? >> I'M ACTUALLY WONDERING WHETHER THE SENTENCE AT 419, THIS IS PARTIALLY BECAUSE, I WONDER IF IT WOULD HELP TO ACTUALLY SAY THIS IS LESS BECAUSE INHERENT AMBIGUITIES MAY PREVENT PERFECT COMPLIANCE AND BECAUSE THE WAYS -- ONE OF THE THINGS THAT STRUCK ME IN THE PANEL DISCUSSION WAS THE EXTENT TO WHICH EVERYBODY FELT LIKE WE NEED TO BE TOLD WHAT IT'S OKAY TO DO AND WE'RE REALLY TALKING HERE ABOUT ALLOWING THE REGULATED COMMUNITY TO COME UP WITH THINGS THAT MAY BECOME BEST PRACTICES. >> OKAY. . >> [ INAUDIBLE, OFF MIC ]. >> CAN I MAKE A SUGGESTION, STEPHEN? HERE'S MY SUGGESTION. WE SHOULD ELIMINATE THIS ENTIRE RECOMMENDATION SECTION, BECAUSE THE RECOMMENDATION SECTION IS REFLECTING MUCH EARLIER DRAFT OF THIS DOCUMENT AND IT'S NOT NEEDED BECAUSE WE'VE HIGHLIGHTED ACTUALLY RECOMMENDATIONS. AND WE DON'T HAVE TO WORDSMITH EVERYTHING, IT'S RESTATING IN A LESS COMPREHENSIVE WAY. >> IS IT WORTH SCANNING THROUGH TO MAKE SURE THERE'S NOT SOMETHING WE MISSED ABOVE? >> IF YOU WANT TO, WE CAN. I'M PRETTY SURE THERE'S NOTHING IN HERE THAT HAS NOT BEEN SAID ABOVE EXTENSIVELY. >> ALL RIGHT. ANYONE ELSE OBJECT TO TAKING IT OUT? >> TOTALLY MINOR, FOR THE END OF LINE 459, SHOULDN'T IT BE "BETWEEN" RATHER THAN "AMONG"? >> OKAY. >> SO ANY LAST THOUGHTS ON THIS DOCUMENT? MARK, YOU'LL REVIEW IT FOR SPELLING ERRORS AND THAT KIND OF STUFF. >> I WILL. >> SO I THINK -- I'M TRYING TO THINK IF A MOTION IS APPROPRIATE, IF WE NEED TO SEE THE FINAL DOCUMENT. I THINK, YOU KNOW, WE'VE DEALT WITH THE SUBSTANTIVE ISSUES, AND A MOTION TO APPROVE WITH MODS, YOU KNOW, PENDING THE CLEANUP BASICALY AND FINALIZATION. >> YEAH, I THINK EXCEPT FOR SPELLING, MAYBE THERE'S A WITH OR AND, WHATEVER, THERE'S REALLY NO PROBLEM, I DON'T THINK. >> CAN I MAKE ONE MINOR COMMENT THAT WE CAN IGNORE -- IN THE SECTION ON WHY PEOPLE NEED TO NOT GO AT THE BATTLE OF THE FORMS. >> YEP. >> ONE THING I THOUGHT ABOUT AS I READ IT WAS WHY IS IT DIFFERENT NOW, AND I THOUGHT IT WOULD BE POSSIBLE TO PUT IN A JUSTIFICATION OF WE REALLY NEED TO BE SORT OF A LITTLE CHILL HERE BECAUSE OF THE -- IT'S EXACERBATED WITH THE CHANGE IN THE COMMON RULE, WHILE WE'RE WAITING FOR HARMONIZATION, AND BY THE WAY THE WHOLE UNDERLYING IS TO REDUCE BURDEN, TO HARMONIZE, AND MOVE TOWARDS SINGLE IRB, SO THERE'S REALLY. >> A LOT GOING ON. >> IF WE TIED IT TO THE UNDERLYING GOALS IT COMES STRONGER TO BE WHY WE SHOULD BE DOING WHAT WE'RE SAYING IN IT, AND SO IT WOULD JUST BE A LITTLE WORD -- I DIDN'T WORDSMITH IT. >> OKAY. >> ANY COMMENTS FROM PEOPLE OR EX OFFICIOS THAT WE SHOULD TAKE INTO CONSIDERATION AT THIS POINT ? >> I'LL CLEAN THE SPELLING UP IN A MINUTE. AND WHAT ELSE? TELL ME WHAT ELSE. SO IN ADDITION COMPLEXITY ... TRANSITION TO CENTRAL IRBs, REPORTING OF RESULTS, WHAT ELSE? >> [ INAUDIBLE, OFF MIC ]. >> YEAH. >> FOCUSING ON IS THIS GOING TO IMPROVE SUBJECT PROTECTION. >> I'M THINKING MAYBE WE DON'T WANT TO DO THIS, PUT THIS POINT IN THIS WAY, SORT OF AS A CHANGE MADE ON THE SCREEN. WE'RE TRYING TO MAKE A RELATIVELY SIGNIFICANT BUT COMPLICATED POINT. I THINK MAYBE, MARK, YOU SHOULD TAKE IT OFFLINE AN THINK OF LANGUAGE AS OPPOSED TO STANDING AT THE PODIUM AND THINK ABOUT HAVING US -- I'M AFRAID WE'RE GOING TO END UP WITH SOMETHING THAT ENDS AWKWARD. >> MARK, THIS IS MINOR, BUT LOOKING AT IT SOME PLACES YOU SAY SACHRP BELIEVES, AND OTHER PLACES SACHRP RECOMMENDS. I THINK AT TIMES YOU MEAN BELIEVES, AT TIMES YOU MEAN RECOMMENDS, IF YOU COULD LOOK AT THAT AND BE CLEAR WHICH IS WHICH. >> SO -- >> WHAT I'M WORRIED ABOUT, MARK, THE FLOW OF THIS WITH THE OTHER PARAGRAPH WHICH THE PREVIOUS SENTENCE STARTS, IN ADDITION, IT MENTIONS BURDENS AND JUST LOOKS LIKE IT NEEDS SOME ATTENTION TO MAKE THE WHOLE THING PIECE TOGETHER WELL. >> I'M HAPPY TO TAKE IT OUT. LESLIE? >> I MEAN, I DON'T WANT TO HOLD US UP FROM APPROVING THIS DOCUMENT, AND IT WAS MORE -- >> I DIDN'T MEAN TO SUGGEST WE NOT SAY SOMETHING TO THIS EFFECT. I'M NOT SURE COMPOSING THIS WAY IS GOING TO LEAD TO THE BEST DOCUMENT. >> I DON'T THINK THE STATEMENT IS WRONG, STEPHEN. I DON'T KNOW. THE ONE FURTHER, COMPLEXITY, YOU KNOW. >> CAN YOU MAKE IT sIRBs? SINGLE IRBS, I THINK THAT'S THE LANGUAGE THAT'S USED. >> DO YOU LIKE IT, LESLIE? >> I LOVE IT, MARK. >> SO ANYTHING ELSE? I WOULD INVITE A MOTION TO ABOVE THE DOCUMENT PENDING EDITORIAL -- NOT EDITORIAL, GRAMMATICAL CLEANUP BASICALLY. >> SO MOVED IT HUGE THANKS TO MARK. >> SECOND. >> ALL IN FAVOR, SAY AYE. >> AYE. >> OKAY. >> THANK YOU. >> ABSOLUTELY. JULIA, CAN YOU SAVE THIS? I DON'T HAVE ANY OTHER COPY OF IT IN THE WORLD EXCEPT WHAT'S HERE. I DON'T WANT TO TOUCH ANYTHING. >> OKAY. >> SO FIVE-MINUTE BREAK >> BEFORE WE RECOMMENDATION FOR LUNCH WE WORKED THROUGH THE QUESTIONS SACHRP ASKED BY OHRP ABOUT THE KEY INFORMATION, AND THEN THANKS FOR YOUR INPUT. I'VE NOT GONE BACK AND CLEANED IT UP BUT IT'S COMING ALONG NICELY. AFTER THOSE, THE RESPONSES TO QUESTIONS WE HAD A NUMBER OF ADDITIONAL THOUGHTS, GENERAL COMMENTARY ON KEY INFORMATION. AND SO WE'LL WALK THROUGH, YOU CAN SEE THEY ARE NOT NUMBERED. THAT'S FINE. BASICS ARE ALL HERE. IF WE COULD GET SOME FEEDBACK THAT WOULD BE VERY HELPFUL. SO ADDITIONAL COMMENTS? THE FIRST ONE TO BE NUMBERED. SACHRP BELIEVES THE CHANGES TO CONSENT FORM REQUIREMENTS INCLUDING BUT NOT LIMITED TO ADDITION OF KEY INFORMATION OF THE KEY INFORMATION SUMMARY SHOULD LEAD TO NEW WAYS OF ORGANIZING AND PRESENTING THE REQUIRED ELEMENTS OF CONSENT AND ALSO LEAD TO INCLUSION OF NEW INFORMATION THAT IS NOT REQUIRED ELEMENT OF CONSENT AS APPROPRIATE IN ORDER TO BEST FACILITATE INFORMED DECISION MAKING, REFLECTING UNDERSTANDING AND ABILITY TO TRANSLATE PROTOCOL INTO INFORMATION USEFUL TO POTENTIAL SUBJECTS, RESOURCES DEDICATED TO SUPPORTING BETTER CONSENT PREPARATION AND RESEARCH, THE AGENCY SHOULD BE SURE TO TARGET BOTH CONSENT FORM AUTHORS AND THOSE INDIVIDUALS WHO OBTAIN CONSENT AND GUIDANCE AND CONSIDER HOW TO DISSEMINATE GUIDANCE TO THOSE INDIVIDUALS. AND JULIA STEPPED OUT. THIS IS ONE THAT BEGINS WITH BELIEVES RATHER THAN RECOMMENDS, SHE IT TELL US IF THAT'S AN IMPORTANT WORD TO FIX LATER. >> JUST IN THE SAKE OF -- FOR SAKE OF BREVITY DO WE NEED THAT TO FACILITATE BY POTENTIAL SUBJECTS OR JUST INFORMED DECISION MAKING. WE TALK ABOUT POTENTIAL SUBJECTS IN THE NEXT -- >> I THINK THAT COULD DISAPPEAR. >> IS THIS CLEAR ENOUGH? WE TALKED ABOUT THIS A LOT. THE IDEA WAS THAT AS OPPOSED TO TEMPLATES WHICH WE'VE ALL SEEN THAT GET FILLED OUT AND ARE INCOMPREHENSIBLE, HERE IS WHERE THE RISKS GO, AND CLEARLY WE OFTEN SEE CONSENT FORMS NOT NECESSARILY WRITTEN BY WRITERS, BUT RATHER BY PEOPLE WHO PLUG IN THE INFORMATION AT THE TEMPLATES. WE'RE LOOKING FOR A WAY TO GET AWAY FROM THAT. IS THIS CLEAR ENOUGH THAT THAT'S WHAT IT'S ASKING? >> I ACTUALLY THINK THAT BELIEVES IS APPROPRIATE IN THAT FIRST LINE BUT THE RECOMMENDATIONS ARE IN THE LAST TWO SENTENCES. STARTING AT LINE 300. >> SACHRP RECOMMENDS THAT? >> YEAH, AND ALSO THAT THE AGENCIES SHOULD TARGET BOTH. THAT THE AGENCY SHOULD TARGET. >> YEAH. >> OKAY. OKAY, I'M GOING TO KEEP GOING. NOW WE DO HAVE A RECOMMEND. SACHRP RECOMMENDS BECAUSE OF THE TENSION BETWEEN ENFORCEMENT AND ADVANCEMENT MISSIONS, OHRP AND OTHER AGENCIES CONFIRM THERE IS COMPLIANCE FLEXIBILITY GOING FORWARD UNLESS AND UNTIL SUCH TIME AS THERE IS A AGREEMENT ON HOW TO APPROPRIATELY SELECT AND PROVIDE KEY INFORMATION, OHRP SHOULD SPECIFICALLY STATE THAT DIVERGING FROM THE PREAMBLE SUGGESTIONS OF KEY INFORMATION WOULD NOT INCUR COMPLIANCE RISK AS LONG AS FULL CONSENT DOCUMENT MEETS REQUIREMENTS OF REGULATIONS, TO ENCOURAGE BETTER APPROACHES TO PRESENTING KEY INFORMATION AND IMPROVEMENT OF THE CONSENT FORM AND PROCESS AS A WHOLE, OTHERWISE RESEARCHERS AND IRBs WILL BE RELUCTANT TO DEVIATE FROM CURRENT PRACTICES ERR ON THE SIDE OF MORE IS BETTER TO ENSURE COMPLIANCE. >> THIS MAY BE AN IGNORANT QUESTION. ENFORCEMENT AND ADVANCEMENT MISSIONS, WHAT IS THE ADVANCEMENT MISSION OF OHRP? I MEAN I'M NOT SAYING THAT ENFORCEMENT IS THE WHOLE MISSION BUT IS THAT THE RIGHT WORD? IT SHOULD BE COMPLIANCE AND POLICY OR -- >> I WAS WONDERING IF SOMETHING ON THE POLICY SIDE, YEAH. >> YEAH. >> AND -- DO WE HAVE TO FLESH IT OUT, BETWEEN ENFORCEMENT OF REGULATION AND ADVANCEMENT OF POLICY OR -- SO IT LOOKED LIKE THIS IN. >> THAT PARALLELS THINGS WE'LL TALK ABOUT IN THE OIG REPORT. >> I WAS THINKING THAT. >> THAT READS AWKWARD. COULD BE TENSION BETWEEN THE MISSION -- TO ADVANCE POLICY. >> YEAH. LIKE THAT. >> JUST MAKE MISSIONS PLURAL. >> OH YEAH. THANKS. >> I GUESS I'M STILL STRUGGLING WITH WHAT -- I KNOW WHAT ENFORCEMENT MEANS. WHAT DOES ADVANCED POLICY MEAN IN THE CONTEXT OF HOW DOES THAT JUSTIFY FLEXIBILITY TO CREATIVELY INTERPRET THE CONSENT FORM REGULATION? I KNOW WHAT WE'RE TRYING TO SAY, ENFORCEMENT IS BASICALLY MAKING SURE YOU'RE COMPLIANT AND ON THE OTHER SIDE YOU WANT TO IMPROVE THE RESEARCH ENVIRONMENT BASICALLY PARTICULARLY FOR PARTICIPANTS IN THE COMMUNICATION. >> I I DON'T KNOW WHY WE NEED ALL OF THAT. IF YOU TAKE OUT THAT AND JUMP RIGHT TO WHAT IT ACTUALLY WANTS THE RECOMMENDATION TO BE. >> YEAH. >> I'M GOOD WITH THAT. >> I THINK THE REASON THAT WAS IN THERE WAS BECAUSE IT KEEPS BECOMIN CLEARER AND CLEARER THAT EVERYBODY WANTS TO BE TOLD WHAT'S THE RIGHT THING TO DO BECAUSE THEY ARE AFRAID OF THE HAMMER, AND SO WE WERE TRYING TO EMPHASIZE THERE'S SOMETHING OTHER THAN THE HAMMER, BUT IT'S NOT REALLY NECESSARY. BY THE TIME WE GET TO THIS POINT. >> YEAH, THERE ARE OTHER PLACES IN THE DOCUMENT WHERE WE HAVE CALLED OUT THE NECESSITY FOR FLEXIBILITY. SO I DON'T THINK IT HURTS TO CUT OUT THOSE WORDS. BECAUSE THAT'S THE HEART OF IT, IRBs FEELING THERE STILL IS ABILITY TO BE FLEXIBLE AND BE CREATIVE IN COMING UP WITH WAYS TO MEET THE REGULATORY REQUIREMENTS. >> SO THEN THE WORK OF THIS RECOMMENDATION IS PURELY TO ADDRESS THE HAMMER. >> I THINK SO. >> OKAY. >> SO YOU THINK IT COULD BE READ AS -- SORRY. DO YOU THINK IT COULD BE READ AS, WELL, WE DON'T KNOW HOW TO TELL YOU HOW TO COMPLY WITH WHAT'S IN THE NEW REGULATION AND PREAMBLE, SO WE'RE JUST SAYING WE DON'T KNOW, AND WE'RE NOT GOING TO ENFORCE WHAT'S IN THERE? BECAUSE IF I'M AN IRB OR A PROJECT THAT'S UNDER THE GUN, I DON'T REALLY HAVE TIME TO BE CREATIVE AND I DON'T KNOW HOW TO BE CREATIVE, AND YOU HAVEN'T TOLD ME HOW TO BE CREATIVE SO IT SOUNDS LIKE YOU'RE TELLING ME I CAN DO WHAT YOU'RE DOING I'VE BEEN DOING AND YOU'RE NOT GOING TO ENFORCE ANYTHING. >> I READ IT DIFFERENT, WHICH IS TO MEET THESE NEW REQUIREMENTS WE MAY WANT TO THINK OUTSIDE THE BOX, AND WOULD PREFER NOT TO BE TOLD THERE'S ONLY ONE WAY YOU CAN ACHIEVE THAT. >> THAT'S WHAT WE WANT TO SAY, IT MAY READ IN A SLIGHTLY DIFFERENT WAY. >> CHOICE OF WORDS, FLEXIBILITY, IS MORE EXPLANTORY THAN WHAT WE HAD IN THE LAST DOCUMENT, WHERE WE HAD ENFORCEMENT DISCRETION. I THINK -- I DON'T KNOW AGAIN AS WE DISCUSSED WHEN THE PANEL WAS HERE, I WOULD THINK THAT PEOPLE COULD PROVIDE RATIONALE AND STRONG JUSTIFICATION FOR WHAT THEY WERE DOING, AND THAT MIGHT BE SUFFICIENT, AS OPPOSED TO, YOU KNOW, PARTICULAR THINGS THAT WERE IN THERE OR NOT, PEOPLE WITH GOOD EVIDENCE CAME TO A PARTICULAR CONCLUSION, THE PROCESS SHOULD BE ADEQUATE AS FAR AS COMPLIANCE. I DON'T KNOW HOW TO SAY THAT. BUT I THINK IT'S IMPLIED. >> I THINK IT'S THERE. ALL WE'RE SAYINGIF YOU WANT TO DO SOMETHING OTHER THAN THE LIST IN THE PREAMBLE, THAT'S OKAY. WE'RE NOT GOING TO DROP THE HAMMER. RIGHT? SO YOU HAVE TO COME UP WITH SOMETHING, RIGHT? YOU HAVE TO STILL COMPLY WITH THE NEW REGULATIONS WHICH HAS KEY INFORMATION, CONCISE SUMMARY, YOU CAN'T DO WHAT YOU'VE BEEN DOING. IT'S JUST THAT YOU DON'T NECESSARILY HAVE TO DO WHAT THE PREAMBLE SAYS. IF YOU ARE UNDER THE GUN, NOT CREATIVE, WHATEVER IT IS, THEN YOU COULD POTENTIALLY COMPLY WITH THE PREAMBLE LIST. >> AND THE PREAMBLE REMAINS THE PREAMBLE, THE TEXT OF THE REGULATION ITSELF IS PRETTY LIMITED. >> I THINK THERE'S ALSO SOME DANGER IN TAKING EACH OF THESE BY THEMSELVES, SO I THINK THE PRECEDING BULLET OR NUMBER, WHATEVER, WHICH TALKS ABOUT INCREASED RESOURCES AND RESEARCH AND GUIDANCE TO INDIVIDUALS WHO ARE WRITING CONSENT, I MEAN, I DON'T THINK WE CAN DO ANY OF THIS IF WE'RE ALL OPERATING ON THE OLD MODEL. UNLESS WE JUST TAKE THOSE FIVE THINGS OUT OF THE PREAMBLE AND CALL THAT THE KEY INFORMATION. >> YEAH. >> SO IS COMPLIANCE FLEXIBILITY INTENDED TO FACILITATE DEVELOPMENT OR IS IT SIMPLY COMPLIANCE FLEXIBILITY BECAUSE WE DON'T QUITE KNOW WHAT WE'RE ASKING FOR? BECAUSE I THINK IT'S INTENDED TO FACILITATE THE DEVELOPMENT, THE FURTHER DEVELOPMENT. YET I DON'T THINK WE'RE QUITE SAYING THAT IN THAT PARAGRAPH. MAYBE THAT'S THE LEAP WE NEED TO MAKE. >> IT SAYS UNLESS UNTIL SUCH TIME THERE'S AGREEMENT HOW TO SELECT AND PROVIDE KEY INFORMATION, DIRECTED AT THE -- YOU KNOW, IT'S HARD TO FIGURE OUT EXACTLY HOW WE'RE GOING DO THIS AND WE WANT PEOPLE TO DO IT SO THAT RIGHT NOW WHILE WE'RE IN THE TRANSITION AS LONG AS YOU'RE DOING A GOOD FAITH EFFORT THAT WE SHOULDN'T HAVE THE HAMMER COME DOWN, AND THAT -- BUT WE'RE GOING TO MOVE TO A PLACE WHERE WE CAN PROVIDE BETTER GUIDANE. >> MAYBE WE NEED TO COMBINE THIS INTO THE SAME PARAGRAPH AS THE ONE BEFORE BECAUSE I THINK THE PROBLEM IS IF YOU SCROLL UP, I THINK THE PRECEDING PARAGRAPH CAPTURES THE POINT OF CREATIVITY, AND THEN WE SAY, YOU KNOW, ALMOST AS A CONSEQUENCE OF THAT, THAT'S NOT GOING TO HAPPEN IF YOU THINK YOU'RE GOING TO BE FOUND OUT OF COMPLIANCE EVERY TIME YOU TRY SOMETHING THAT'S NOT ON THE LIST. SO I DON'T KNOW HOW TO TIE THOSE TWO THINGS TOGETHER BUT I THINK EACH PARAGRAPH DOES SOMETHING DIFFERENT AND THEY ARE SYNERGISTIC. >> IT LOOKS LIKE IF WE PUT THE SECOND ONE FIRST AND COMBINE THEM, THAT WILL WORK. BECAUSE THE SECOND ONE BASICALLY SAYS CONFIRM THERE'S FLEXIBILITY, WE'RE TRYING TO ENCOURAGE CREATIVITY, AND THEN THE FIRST ONE SAYS -- >> DEVELOP GUIDANCE TO HELP FACILITATE THAT. >> I DON'T KNOW HOW TO TIE THE TWO THINGS TOGETHER. BUT I THINK -- >> THAT SOUNDS BETTER. YOU HAVE TO PUT THE KEY INFORMATION UP FRONT. THERE IS IN THE PREAMBLE A SUGGESTION ABOUT WHAT THE KEY INFORMATION IS. THAT'S A FALLBACK STRATEGY. BUT IT SHOULDN'T BE THE ONLY STRATEGY BECAUSE WE'RE NOT ENTIRELY SURE THAT THAT'S THE BEST STRATEGY, SO IF YOU WANT TO DEVELOP BETTER STRATEGIES YOU NEED FLEXIBILITY TO DO THAT, YOU HAVE IT. THAT'S WHAT I THINK WE'RE TRYING TO SAY. >> WE'RE GOING TO PUT THAT AUDIO IN A LITTLE BUBBLE THAT YOU CLICK ON RIGHT NEXT TO THE PARAGRAPH. >> THAT'S WHAT IT WOULD LOOK LIKE IF WE REVERSED AND SQUISHED TOGETHER, THERE MAY BE A FEW EXTRA WORDS THAT CAN BE TAKEN AWAY BUT -- ALL RIGHT. WE'LL LET THAT SIT AND IF WE WANT TO COME BACK FRESH IN A FEW MINUTES WE CAN DO THAT. ALL RIGHT. DOWN TO 323, SACHRP RECOGNIZES FLEXIBILITY IS INHERENT IN CONCEPT OF REASONABLE PERSON AS APPLIED TO INFORMED DECISION MAKING, RECOGNIZING THAT IT IS IMPOSSIBLE FOR RESEARCHERS TO DETERMINE WHAT INFORMATION EVERY INDIVIDUAL PARTICIPANT WOULD CONSIDER HELPFUL IN DECIDING WHETHER OR NOT TO PARTICIPATE. INSTEAD ASKING RESEARCHERS TO INCLUDE REASONABLE PEOPLE IN THE SAME OR SIMILAR CIRCUMSTANCES WOULD CONSIDER KEY, THUS REQUIRING RESEARCHERS TO CONSIDER POPULATION THEY ARE ENROLLING, AND THE INFORMATION THAT THOSE PEOPLE WOULD REGARD AS KEY. IT'S A LONG SENTENCE. OTHER INFORMATION IS KEY TO FACILITATING SUBJECT'S UNDERSTANDING OF REASONS EACH MIGHT OR MIGHT NOT PARTICIPATE IN THE STUDY. ENDS BY SAYING PARTICIPANTS NEED OPPORTUNITIES TO ASK QUESTIONS. >> SO THERE'S A BUNCH OF REDUNDANCY. NANCY, DO YOU WANT TO -- >> YEAH, ACTUALLY I DON'T THINK IT'S REDUNDANT BECAUSE IT'S SORT OF IMPERFECTLY TRYING TO DO SEVERAL THINGS. IT'S THE REASONABLE PERSON'S STANDARD IS ABOUT WHAT INDIVIDUAL SUBJECTS WANT, BUT ALSO WHAT THEY MIGHT NOT REALIZE THEY NEED TO KNOW, AND THEN IN ADDITION IT'S A QUESTION, THAT'S A QUESTION OF LOOKING AT SUBJECT POPULATIONS BUT THEN INDIVIDUALS NEED THE OPPORTUNITY TO ASK QUESTIONS SO THAT EACH INDIVIDUAL CAN SORT ALL THAT OUT . AND I ALSO THINK THAT THAT PARAGRAPH NOW WILL GO BETTER TO DO ANOTHER FLIP. THE NEXT PART THAT SAYS THE KEY INFORMATION SUMMARY SHOULDN'T BE TREATED AS A STAND-ALONE, THE REASONABLE PERSON DISCUSSION FOLLOWS REALLY WELL FROM THAT. AND THE REASONABLE PERSON STANDARD IS A DISCUSSION, IT'S NOT REALY A RECOMMENDATION, SO IF IT FOLLOWS AFTER WHAT NOW BEGINS AT LINE 337 AND CONTINUES LIKE A LITTLE BIT FURTHER, LIKE THERE'S ANOTHER PARAGRAPH TO THAT. THAT WILL PROBABLY WORK BETTER. SO IF WE MOVE THE REASONABLE PERSON DISCUSSION TO AFTER LINE 344. >> OKAY, SO THESE TWO TOGETHER WOULD MOVE UP ABOVE. >> YEAH. >> IS THE REASONABLE PERSON STANDARD REFERENCE EITHER IN THE PREAMBLE OR IN THE REGULATIONS? >> IT'S IN THE REGULATIONS BUT IT'S NOT PART OF KEY INFORMATION. IT'S IN THE REGULATIONS PROPER, SO WE FELT THE NEED BECAUSE THIS IS BOTH ABOUT KEY INFORMATION AND ABOUT INFORMED CONSENT IN GENERAL TO MAKE SOME REFERENCE TO IT SINCE IT'S COMPLETELY UNDEFINED IN THE REGS. >> ALL RIGHT. NOW 323 WE'VE GOT THE LITTLE PARAGRAPH ABOUT REGARDING KEY INFORMATION, REGARDING KEY INFORMATION SUMMARIES, THE OPPORTUNITY TO ASSIST SUBJECTS IN DECISION MAKING, AND THAT WOULD SERVE AS -- SHOULD FRAME THE PURPOSE AND PROCESS OF DECISION MAKING. THE NEXT PARAGRAPH IS KEY INFORMATION IS NOT -- SHOULDN'T BE REGARDED AS STAND-ALONE DOCUMENT. AND THEN MOVES INTO THIS LONGER ONE ABOUT THE FLEXIBILITY AND THE REASONABLE PERSON APPROACH. OR NEED FOR FLEXIBILITY AND REASONABLE PERSON APPROACH. >> I WONDER IF WE COULD COMBINE THE TWO PREVIOUS POINTS BECAUSE THEY SEEM CLOSELY RELATED. >> THEY DO SEEM VERY RELATED. I THINK -- >> I THINK THAT WOULD HELP THE FLOW. >> YEAH. I SUSPECT DAVID WAS TRYING TO PEEL OUT WHAT MIGHT BE -- >> IN THE FOLLOWING PARAGRAPH THERE'S SOME SENTENCES THAT I THINK ARE REALLY UNNECESSARILY WORDY. >> CERTAINLY PARTS OF THEM CAN COME OUT. >> WOULD YOU CONSIDER, 333, DETERMINE WHAT INFORMATION EVERY INDIVIDUAL PARTICIPANTS WOULD CONSIDER HELPFUL IN DECIDING WHETHER TO PARTICIPATE, STOP THERE, INSTEAD WHAT REASONABLE PEOPLE IN THE SIMILAR WOULD CONSIDER KEY, THUS REQUIRING RESEARCHERS TO CONSIDER CHARACTERISTICS OF THE SUBJECT POPULATION, PERIOD. BECAUSE, AGAIN, IN ORDER TO IDENTIFY THE INFORMATION THAT'S WHAT WE SAID RIGHT ABOVE. AND THEN WE NEED TO TAKE THAT AS WELL AS WHAT OTHER -- >> THAT COULD JUST BE THE REST OF THAT SENTENCE AND THEN IT'S NOT TOO TERRIBLY LONG, BECAUSE IT'S CONNECTED. SUBJECT POPULATION ALONG WITH OTHER THINGS. >> YEAH. TAKE OUT THE -- YEAH. >> HOW ABOUT SAYING TO CONSIDER THE CHARACTERISTICS OF THE SUBJECT POPULATION AND WHAT INFORMATION IS KEY TO FACILITATING POTENTIAL SUBJECT'S UNDERSTANDING, GET RID OF SOME OF THAT STUFF IN THE MIDDLE AS WELL AS WHAT OTHER -- WHATEVER OTHER -- YOU DON'T NEED THAT. >> SO I LOST YOU. I'M FINDING MYSELF. >> GET RID OF AS WELL AS WHATEVER OTHER. INSTEAD OF THE CHARACTERISTICS OF SUBJECT POPULATION AND WHAT INFORMATION IS KEY. FACILITATES PUBLIC UNDERSTANDING . >> I THINK THAT DOESN'T QUITE MAKE CLEAR WHY WE WANT TO CONSIDER THE CHARACTERISTICS OF THE SUBJECT POPULATION. >> HOW ABOUT CHARACTERISTICS OF THE SUBJECT POPULATION AND OTHER INFORMATION THAT IS KEY. >> WELL, THAT DOES CHANGE. WHAT WOULD BE AN EXAMPLE OF -- >> SO I THINK WHAT NANCY'S TRYING -- THERE ARE TWO THINGS. THERE'S ONE THING PUT YOURSELF IN THE SHOES OF WHAT THEY WOULD EXPRESS INTEREST IN, AND THEN THERE'S ALSO INFORMATION THEY MAY NOT EVEN KNOW THEY SHOULD BE INTERESTED IN BUT NEED TO KNOW ABOUT. I THINK IT'S THE LATTER THAT WE'RE TRYING TO CAPTURE WITH THE SECOND HALF. >> I'M REREADING, I SEE THAT. >> CHARACTERISTICS AND LIKELY PREFERENCES OF THE SUBJECT POPULATION? THAT WOULD HELP DISTINGUISH ON THE ONE HAND WHAT THEY THINK THEY WANT TO KNOW AND OTHER THINGS THEY MAY NOT KNOW THAT THEY THINK THEY WANT TO KNOW. >> [ INAUDIBLE, OFF MIC ]. >> THE LAST SENTENCE, EVEN THOUGH THE IRB AND THE INVESTIGATOR CAN ONLY DO THIS AT A POPULATION LEVEL, THEN INDIVIDUALS NEED TO BE ABLE TO GET MORE. >> MAYBE WE DON'T NEED TO GET INTO THE OTHER INFORMATION SINCE WE ALREADY TALKED ABOUT HAVING -- THAT'S THE FOCUS OF EVERYTHING ELSE WE'VE TALKED ABOUT. WHEREAS THIS REALLY IS WHAT THE REASONABLE PERSON STANDARD DOES AND THAT IS THE THINKING ABOUT THE PERSON IN SAME OR SIMILAR CIRCUMSTANCES, WHICH MEANS PUTTING YOURSELVES IN THE SHOES. >> YEAH, I CONFESS I'M A LITTLE BIT WORRIED ABOUT A SUBJECT POPULATION THAT SAYS, ALL WE WANT TO KNOW IS X, DON'T TELL US ABOUT Y AND Z. MAYBE THAT'S AN EXCESSIVE CONCERN OF MINE. >> BUT, YEAH, YOU KNOW, I'M SURE I THREW THIS IN HERE TOO. BUT I AM THINKING IN THIS CONTEXT THAT WE'VE ALREADY TALKED ABOUT GOING THROUGH THE PROCESS OF THINKING ABOUT WHAT IS KEY, SO THIS IS ADDING TO IT IN ADDITION TO ALL THAT OTHER STUFF, YOU ALSO HAVE TO THINK ABOUT WHAT THE PEOPLE IN THOSE PARTICULAR CIRCUMSTANCES, THE PEOPLE YOU'RE ACTUALLY RECRUITING MAY THINK OF THIS KEY. >> OKAY. SO HOW ABOUT THIS THEN. CONSIDER THE CHARACTERISTICS OF THE SUBJECT POPULATION IN ORDER TO -- IN ORDER TO IDENTIFY EVERYTHING THAT MAY BE KEY OR SOMETHING LIKE THAT, SO THAT IT'S NOT JUST -- WE'RE NOT ONLY CONSIDERING THE SUBJECT POPULATION, JUST ADDING THAT TO THE OTHER CONSIDERATIONS. >> THE EXAMPLE OR BE CLEAR THERE ARE TWO TYPES OF THINGS? IT COULD JUST BE YOU GET EVERYTHING THAT YOU NEED BY THINKING ABOUT WHAT THE PARTICIPANTS WOULD WANT, RIGHT? LIKE WHAT THEIR PREFERENCES ARE, BUT THERE MAY BE THINGS THEY DIDN'T THINK OF BUT NOTE IN EVERY CIRCUMSTANCE. ANY OTHER INFORMATION, THAT GIVES MORE WIGGLE ROOM. >> LET ME ASK SOMETHING. WHAT WOULD BE WRONG WITH SAYING ASKS RESEARCHERS TO INCLUDE WHAT REASONABLE PEOPLE IN THE SAME OR SIMILAR CIRCUMSTANCES WOULD WANT TO OR NEED TO CONSIDER KEY, I MEAN WE'RE REALLY -- THEN GET RID OF ALL THE REST OF THIS STUFF. BECAUSE YOU REALLY WANT TO CONSIDER THE POPULATION, EVEN IN THE THINGS YOU FEEL THEY NEED TO KNOW. IT DOESN'T -- THE REASONABLE PERSON IS NOT JUST ASKING PEOPLE WHAT THEY WANT TO KNOW. >> SO WE STRIP OUT ALL THAT? OR EVEN FURTHER? I THINK JUST THAT. >> (INAUDIBLE). >> THAT'S A SMALL POINT. >> WANT TO OR NEED TO CONSIDER KEY TO KEEP IT -- WOULD WANT TO OR SHOULD NEED TO OR SOMETHING. >> [ INAUDIBLE, OFF MIC ]. >> LIKE THAT. THEN THE LAST SEVERAL LINES WOULD STILL STAY, RIGHT? SO IT WOULD LOOK LIKE THAT. >> I THINK WHAT STEPHEN HAD SAID BEFORE WAS WOULD WANT OR NEED TO KNOW, AND THAT MIGHT DEAL WITH THE AWKWARDNESS OF THE SENTENCE. >> TAKE OUT THE INFORMATION. >> YEAH. >> YEAH. >> WHAT DO REASONABLE PEOPLE WANT OR NEED TO KNOW. >> WHEN WE'RE DONE I HAVE A BUNCH OF CONSENT FORMS. [LAUGHTER] >> OKAY. THAT WILL BE SHORTER. THOSE PARAGRAPHS MOVED. WE'RE DOWN HERE, MAKE IT EASIER TO PROVIDE AND ORGANIZE THE INFORMATION TO FACILITATE COMPREHENSION, UNDERSTANDING. YEAH, THIS IS REALLY JUST -- THIS PARAGRAPH SORT OF REMINDS EVERYBODY E-CONSENT OR NON-TRADITIONAL MEDIA MAY BE A GOOD VEHICLE FOR DOING THIS, FOR IMPLEMENTING THE KEY INFORMATION REQUIREMENTS AND GENERALLY IMPROVING THE PRESENTATION OF INFORMED CONSENT INFORMATION. >> CAN WE TAKE OUT THE PERSPECTIVE SUBJECT? WHAT FACILITATES COMPREHENSION AND UNDERSTANDING OF THE REASONS WHY, THERE'S A LOT OF EXTRA STUFF THERE. DO WE NEED THE "FOR INSTANCE"? >> NO, I THINK ANYBODY READING THIS SHOULD UNDERSTAND WE'RE TALKING ABOUT -- A VARIETY OF ELECTRONIC FORMATS. >> DELETE FOR INSTANCE. >> TELLING PEOPLE IT'S ELECTRONIC SEEMS REDUNDANT. >> [ INAUDIBLE, OFF MIC ]. >> RIGHT. ALL RIGHT. 363, EMPIRICAL RESEARCH BEFORE AND AFTER CONSENT REQUIREMENTS, IMPORTANT TO DETERMINE WHETHER AND HOW MODELS CAN BEST FACILITATE SUBJECT'S UNDERSTANDING AND USE RESEARCH RESULTS TO IMPROVE CONSENT FORM AND PROCESS, SHOULD BE CONDUCTED AS ONGOING PROJECT, SO ON. THIS IS REALLY A -- REALLY A CALL FOR MORE RESEARCH IN THIS AREA AND MENTIONS THE POSTING OF INFORMED CONSENT DOCUMENTS MAY FACILITATE THAT. >> I THINK I WAS RESPONSIBLE FOR THIS PARAGRAPH. I'M HAPPY WITH IT. THERE'S A COUPLE TWEAKS. SO ONE QUESTION FOR THE GROUP WHETHER THE TIME FRAME FOR EMPIRICAL RESEARCH BEFORE IMPLEMENTATION OF CONSENT REQUIREMENTS, THAT SHIP HAS SAILED, SO I THINK WE PROBABLY WANT TO SAY EMPIRICAL RESEARCH SHOULD BE CONDUCTED. >> ON THE? >> YES, CONDUCTED IN LIGHT OF IMPLEMENTATION OF THE NEW CONSENT REQUIREMENTS, SOMETHING LIKE THAT. AND THEN ON LINE 367, I WASN'T SURE IF THAT WAS ONGOING CONTINUOUS IMPROVEMENT, DO WE MEAN ONGOING QUALITY IMPROVEMENT? ONGOING CONTINUOUS? CONTINUOUS QUALITY IMPROVEMENT PROJECT OR SOMETHING. OKAY, THAT'S PINE. FINE. >> WHAT ARE WE DOING? >> MAKING THAT ONGOING. THE NEXT CLAUSE, SHOULD RELY ON FINDINGS OF READABILITY AND NUMERACY, I THINK WHAT WE'RE TRYING TO SAY IS LIKE DO PEOPLE UNDERSTAND, RIGHT? IT'S A COMPREHENSION QUESTIONS. I DIDN'T KNOW IF WE WERE TRYING TO REFER TO SOMETHING ELSE THAT MAYBE I'M NOT AWARE OF. >> WHY DON'T WE JUST TAKE THAT OUT. >> I THOUGHT WE SHOULD TAKE IT OUT, I AGREE AGREE. I I AGREE WE SHOULD GET RID OF THE AND SHOULD CLAUSE, THIS RESEARCH SHOULD BE CONDUCTED IN A CONTINUOUS IMPROVEMENT PROJECT. THE IDEA IS THE LEARNING SYSTEM. >> I LOST IT. THE PROJECT IDEA BOTHERS ME. IT SUGGESTS THERE'S WALLS AROUND IT, IT'S A PARTICULAR THING. AS A CONTINUOUS IMPROVEMENT EFFORT OR RESEARCH SHOULD BE CONDUCTED TO FACILITATE CONTINUOUS IMPROVEMENTS IN THE CONSENT FORM AND PROCESS, THE PROJECT SUGGESTS IT'S ONE THING. >> RESEARCH CONDUCTED AS CONTINUING EFFORT TO IMPROVE INFORMED CONSENT. THAT MIGHT BE WHAT WE SAY ABOVE AND USE RESEARCH RESULTS TO IMPROVE CONSENT FORM PROCESS, MAYBE YOU'RE RIGHT, DELETE THAT WHOLE SENTENCE. >> OKAY. >> WE CAN DELETE THE WHOLE SENTENCE. >> 371, BE MORE SPECIFIC, CONDUCTED ON LARGE SCALE ACROSS SITES AND STUDIES. >> STUDIES AND POPULATIONS YES, THAT'S GOOD. >> CAN WE MAKE THIS A RECOMMEND INSTEAD OF BELIEVES? >> THIS MIGHT BE OVERKILL, THE LAST THING I WANTED WAS ON 374, THE VERY END, NEW SENTENCE THAT WRAPS UP TO SAY IN OTHER WORDS WHAT DO SUBJECTS VIEW TO BE KEY INFORMATION IN DIFFERENT CONTEXTS. THAT'S THE RESEARCH QUESTION THAT WE NEED TO ANSWER. AND WHY THIS WHOLE PROJECT HAS BEEN SO DIFFICULT, THERE'S NOT GOOD EMPIRICAL DATA. >> I DON'T KNOW THAT'S WHAT WE -- THIS GETS BACK TO THE THING WE DISCUSSED ABOVE, WHAT PEOPLE WANT AND NEED TO KNOW. I DON'T KNOW, IT'S NOT JUST WHAT SUBJECTS VIEW AS KEY INFORMATION. I MEAN, SO I DON'T KNOW, WE TALKED ABOUT THAT ALREADY FROM THE REASONABLE PERSON STANDARD SO I DON'T KNOW THAT I WOULD PUT THAT IN. >> A CONCERN ABOUT THIS RECOMMENDATION, SOUNDS LIKE WE'RE SAYING WE THINK WE'RE READY TO DO LARGE-SCALE EFFORT HERE, THAT WILL BE REALLY GENERALIZABLE ACROSS LOTS AND LOTS OF STUDIES, AND I THINK THAT'S A GOAL THAT WOULD BE REALLY WONDERFUL BUT I'M NOT SURE THAT WE'RE METHODOLOGICALLY READY AND MAIN DATE THE RESEARCH THAT SHOULD BE DONE NEXT SEEMS PREMATURE. I COULD IMAGINE SMALLER SCALE COGNITIVELY ORIENTED STUDIES ON COMPREHENSION THAT RELATE TO DIFFERENT KINDS OF RESEARCH AND DIFFERENT CHARACTERISTICS. WE NOW HAVE BEHAVIORAL RESEARCH, WE HAVE CLINICAL TRIALS, WE HAVE -- I'M JUST -- I DON'T NECESSARILY THINK THIS MANDATE FOR A LARGE SCALE GENERALIZABLE STUDY IS NECESSARILY THE ONLY WAY TO GO OR REALLY THE WAY WE OUGHT TO GO NEXT. >> IS THAT -- I DON'T READ IT THAT WAY. I READ IT AS A GENERALIZABLE AND LARGE SCALE EFFORT, RESEARCH AGENDA BASICALLY NOT A STUDY. SO -- >> SOUNDS LIKE WE'RE LOOKING FOR A BIG N AND POWER CALCULATIONS, WHICH MAY BE TRUE, I'M NOT SURE IT'S WHAT WE'RE READY TO DO. >> [ INAUDIBLE, OFF MIC ]. >> WE ARE TALKING ABOUT THE RESEARCH AGENDA, NOT THE STUDY. >> MAKE IT CLEAR THAT'S WHAT WE'RE THINKING ABOUT, IT MAKES MORE SENSE. I'M PROBABLY THE LAST PERSON IN THE ROOM TO REALIZE THIS BUT PCORI HAS BEEN DOING A LARGE AMOUNT OF RESEARCH KIND OF ASSESSING HOW SUBJECTS -- HOW WELL SUBJECTS FEEL THE CONSENT FORM ACTUALLY REPRESENTED WHAT THEIR EXPERIENCE IN THE STUDY WAS. AND SO THERE'S A LOT OF STUFF OUT THERE THAT IS PRETTY DIRECTLY TRANSLATABLE INTO THE CONCERNS THAT WE'RE TALKING ABOUT HERE. >> HOW DO WE FEEL ABOUT THIS PARAGRAPH? >> MAYBE WE WANT TO TAKE OUT THE LAST SENTENCE? >> THERE'S STILL A GAP. >> [ INAUDIBLE, OFF MIC ] >> THAT WAS SIX YEARS AGO. >> LEAVE IT, OKAY. ALL RIGHT. 376, SACHRP NOTES EXISTING ELEMENTS OF TRADITIONAL APPROACHES HAVE EMPHASIZED BENEFIT AND RISK, NOT GIVEN SIMILAR ATTENTION TO BURDEN OR IMPACT OF RESEARCH ON INDIVIDUAL'S NORMAL LIFE ACTIVITIES, FLEXIBILITY PROVIDED SHOULD BE USED TO ADDRESS SUCH INTACT, IMPACT A CERTAIN BUT BENEFITS AND HARMS ARE NOT. >> I LIKE THAT BUT I'M NOT SURE THAT IT BELONGS AFTER. IT SHOULD BE WAY EARLIER. >> YEAH. I ACTUALLY DON'T KNOW IF THAT BELONGS IN THE INITIAL SECTION WHERE WE TALK ABOUT, YOU KNOW, THE THINGS THAT SHOULD BE INCLUDED AND -- I CAN THINK ABOUT THAT. >> THAT'S IN THE QUESTIONS AND THAT WE'RE GOING TO REFER TO IN THE APPENDIX. >> YEAH. THIS NEEDS TO BE MOVED SOMEWHERE, AT A MINIMUM, WHETHER IT'S UP IN ANSWER TO THE SIX QUESTIONS OR SOMEWHERE IN THIS PART, BUT I THINK WE HAVE A CONSENSUS THAT JUST NEEDS TO BE MOVED. >> IT'S NOT A RECOMMENDATION, DOESN'T BELONG HERE. OBSERVATION. >> MAY GO IN QUESTION FIVE TALKING ABOUT RISKS AND BENEFITS. >>A, OKAY. WE'LL MOVE THAT. I DEGREE WITH STEPHEN, THIS IS A GOOD PARAGRAPH AND USEFUL, FINDING THE RIGHT PLACE IS THE MORE IMPORTANT THING. LESLIE, I'LL SEE IF IT FITS QUESTION FIVE. >> FITS WITH OTHER COMMENTARY IN THAT SECTION. I THINK IT'S JUST WHERE IN THAT GROUP. >> THAT GETS US TO CONCLUSION, REVISED REGULATIONS, REQUIREMENT, SOME IS RESTATEMENT, GOT TO BEGIN WITH THE INFORMATION. NOT A WHOLE LOT THERE. >> I THINK MAYBE WE WANT TO GO BACK TO THE PREAMBLE A BIT BUT I THINK RATHER THAN SAYING MAKE -- THERE'S AN OPPORTUNITY TO -- TO MAKE PARTICIPATION IN RESEARCH BETTER FOR RESEARCH SUBJECTS. >> RIGHT AT THE END DOWN HERE? >> YEAH. >> [ INAUDIBLE, OFF MIC ] >> I KNOW. JUST TAKE OUT THAT SENTENCE. WE'VE SAID IT IN THE PREVIOUS ONE, INFORMED CONSENT, MUST BE ORGANIZED. JUST A SIGNIFICANT OPPORTUNITY TO MAKE INFORMED CONSENT PROCESS BETTER FOR RESEARCH SEARCH SUBJECTS. >>. APPENDIX 2 WILL NOW BE APPENDIX 1. WE'VE AGREED ON THAT. I GUESS APPENDIX 1 CAN NOW BE APPENDIX 2. THIS WAS THE LIST OF QUESTIONS THAT WE THOUGHT MIGHT HELP PEOPLE PUTTING TOGETHER CONSENT MATERIALS, GET TO THE HEART OF WHAT IS KEY INFORMATION FOR THEIR STUDY. >> THIS IS REALLY A TOOL AIMED AT PEOPLE WRITING CON SEVEN FORMS, SO SHOULDN'T BE TAKEN AS A Q&A. NERD IN OTHER WORDS, WHAT ARE THE MAIN REASONS THE SUBJECT WILL -- (INAUDIBLE) -- MAYBE WE JUST WANT TO SAY -- (INAUDIBLE) -- THAT A WRITER OF CONSENT FORMS MIGHT DO. >> BUT ADD IT'S FOR PEOPLE THAT ARE CREATING -- >> (INAUDIBLE) >> A LIST OF QUESTIONS DESIGNED TO HELP WRITERS OF CONSENT FORMS IDENTIFY -- (INAUDIBLE). >> IS IT JUST FOR THE WRITERS OR IS IT ALSO A TOOL FOR IRBs TO BE THINKING DID THE WRITER OF THE CONSENT FORM ACTUALLY IDENTIFY THOSE KEYS. >> AND IRBs.. >> AND I'LL FIX THIS BECAUSE IT'S NO LONGER THE SECOND THING. ALL RIGHT. AND THEN APPENDIX 3 WAS AS YOU RECALL WE HAD THE PRESENTATION BY DR. ALPERT OF THE ABSCO HEALTH OPTION GRID, THIS IS A REVIEW OF HIS PRESENTATION. I THINK THAT'S PRETTY STRAIGHTFORWARD BECAUSE WE DON'T MAKE ANY RECOMMENDATIONS ABOUT IT, WE JUST SAY IT'S SOMETHING WE CONSIDERED IN CREATING OUR DOCUMENT. AND THEN APPENDIX 4 TALKS VERY BRIEFLY ABOUT THE WORK PRESENTED AT SACHRP AT OUR MARCH MEETING, AND AS WITH THE DR. ALPERT PRESENTATION WE SAY THE MATERIALS ARE ALSO ATTACHED. SO THE OTHER THING THAT WE HAVE IS PART OF THIS KEY INFORMATION PACKET OR A NUMBER OF CONSENT FORM EXAMPLES, AND WHILE AFTER GOING THROUGH THIS DOCUMENT I DON'T WANT TO EDIT AND OPEN THEM AND EDIT THEM, YOU KNOW, WE PROBABLY SHOULD DISCUSS WHETHER WE WANT TO PUT THEM ALL FORWARD AS EXAMPLES OR, YOU KNOW, HOW WE FRAME WHAT THEY ARE BECAUSE DAVID DOESN'T REALLY SAY ANYTHING ABOUT IT IN THE DOCUMENT, DON'T SAY ANYTHING ABOUT IT IN THE DOCUMENT. >> SO MY CONCERN WITH THEM IS THAT THEY ARE NOT ALL EQUALLY GOOD, IN MY OPINION. AND I ALSO DON'T KNOW IF WE WANTED TO IDENTIFY, YOU KNOW -- I THOUGHT THE POINT WAS TO SHOW THERE'S SEVERAL WAYS TO DO IT. WE SAID YOU COULD BE CREATIVE, HERE ARE SOME CREATIVE WAYS TO DO IT. SOME OF THEM DID HAVE LIKE SOME VAGUE LANGUAGE ON BENEFITS THAT WENT IN CONTRAST TO WHAT WE HAD RECOMMENDED IN THE DOCUMENT, SO I'M A LITTLE BIT TORN ON WHAT TO DO BECAUSE I DO THINK IT'S HELPFUL TO SEE SOME EXAMPLES YOU COULD DECIDE WE LIKE WHAT THEY DID HERE, DON'T LIKE WHAT THEY DID HERE, JUST TO HAVE SOMETHING TO START FROM. I WOULD BE WORRIED ABOUT THE IMPRESSION THAT WE'RE ENDORSING THESE AS GOOD EXAMPLES. THEY ALL HAVE THINGS TO RECOMMEND WITHIN THEM, RIGHT? THEY ALL HAVE GOOD ELEMENTS WITHIN THEM BUT I DON'T THINK ANY ONE OF THEM STOOD OUT LIKE A SHINING BEACON. SHINING BEACON.. SHINING BEACON. >> THE IMPORTANCE OF APPEARING IN LINE WITH RECOMMENDATION MAY RING AS ENDORSEMENT WHETHER WE SAY IT IS OR ISN'T. NANCY? >> I THOUGHT EXAM PLES 1 AND 2 WITH VAGUE AND CONFUSING LANGUAGE. I LIKED 3 AND 4, AND THE ADVANTAGE OF 3 AND 4 THEY ARE MORE LIKE TEMPLATES THAN EXAMPLES. MAYBE IF THERE'S SOME WE WANT TO KEEP MY RECOMMENDATION WOULD BE TO KEEP 3 AND 4 AND SAY HERE'S A COUPLE OF EXAMPLES OF WAYS TO THINK ABOUT TEMPLATING A WAY TO THINK THROUGH WHAT SHOULD BE IN KEY INFORMATION. >> SO THESE ARE MOSTLY INSTITUTIONAL PROVIDED THINGS, RIGHT? >> THAT'S CORRECT. >> WE HAVE ACCESS TO A SMALL PART OF THE PEOPLE DOING THIS. AS OPPOSED TO INCLUDING ANY WHETHER WE SHOULD MAKE THE STATEMENT MAYBE IN OUR REFERENCE TO TOOLS OR SOMETHING THAT THERE ARE MANY PEOPLE WORKING ON THESE THINGS. I DON'T KNOW IF THERE'S -- IF THERE WERE LINKS BUT WE'RE NOT GOING TO BE EXHAUSTIVE. HEATHER, I'M SORRY TO CALL ON YOU WHEN YOU'RE -- SO WE'RE TALKING ABOUT -- I DON'T KNOW IF YOU'VE BEEN FOLLOWING BUT THE -- WE RECEIVED I DON'T KNOW FIVE CONSENT FORMULATES FROM FIVE INSTITUTIONS ALMOST ACCIDENTALLY. PEOPLE IN THE ROOM, SUBCOMMITTEES, IT'S OBVIOUSLY A TINY PIECE OF WHAT INSTITUTIONS ARE DOING. THEY ARE OF VARIABLE QUALITY. WE DON'T WANT TO APPEAR TO BE ENDORSING THESE. IS THERE A BETTER WAY, DO YOU HAVE ANY THOUGHT OF, YOU KNOW, A AAMC RESOURCING RESOURCEE OR SOMETHING WE COULD POINT PEOPLE TO TO FIND THINGS SO WE DON'T HAVE ENDORSE THEM BY INCLUDING THEM HERE? >> SO WE WERE SPEAKING RECENTLY WITH A GROUP ABOUT WHETHER THERE COULD BE SOME SORT OF A YELP FOR TEMPLATES, SOME THING WHERE THERE WAS NO SPECIFIC ENDORSEMENT FOR ANYONE BUT A PLACE WHERE INSTITUTIONS COULD VOLUNTEER TO PUT THINGS OR HOUSE THINGS BUT THEN THERE COULD BE AN ACTIVE COMMENTING DISCUSSION ABOUT THEM SO HAVING THEM THERE WOULDN'T BE AN IMPLICIT ENDORSEMENT BUT AT THE SAME TIME DOESN'T MAKE ANY SENSE THAT EACH INSTITUTION BECAUSE THERE'S NO SINGLE PLACE FOR THIS, SO I DON'T THINK IT EXISTS YET. I THINK IT COULD. THERE'S A LOT OF PLACES THAT MIGHT BE VERY WILLING TO HOUSE SOMETHING LIKE THIS AND MAKE IT AVAILABLE. HOPEFULLY I CAN VOLUNTEER US AT THE TIME, WE CAN LOOK INTO IT. I KNOW JUST FROM LOOKING AND BEING SLIGHTLY INVOLVED AT THE CTTI, THE TRANSFORMATION INITIATIVE, HAS DONE A LOT OF WORK IN THIS AREA. I THINK, JERRY, YOU WERE INVOLVED IN THAT 2015 EFFORT TO MAKE TEMPLATES AND HAVE SOME GOOD RESEARCH ON THE WEBSITE. MAYBE THE RECOMMENDATION IS TO EITHER DEVELOP OR IDENTIFY WHERE THESE THINGS COULD GO. WOULD THAT BE A HELPFUL RESOURCE? >> I'M LEANING TOWARDS NOT INCLUDING ANY OF THESE. >> I LEAN THE SAME WAY. I DON'T SEE THE UP SIDE TO IT, AS SOMETHING THAT'S INCLUDED ALONG WITH THESE, WITH THIS DOCUMENT. >> IS THERE A PLACE IN THE DOCUMENT WHERE WE COULD ALERT PEOPLE TO THE FACT THAT THERE ARE MULTIPLE EFFORTS ON THIS? AND WE CAN'T GIVE SPECIFIC WEBSITES BUT WHETHER IT'S CTTI OR LOCAL ACADEMIC INSTITUTIONS, MAJOR ACADEMIC INSTITUTIONS, WHATEVER YOU WANT TO CALL THEM? NANCY? >> I DIDN'T WANT TO INTERRUPT. >> IT'S FINE. >> IT MAKES SENSE TO ME TO NOT INCLUDE THEM BUT LET ME ALSO THEN ASK ABOUT THE PRESENTATIONS FROM ALPERT AND THE DARTMOUTH FOLKS. WE'RE NOT ENDORSING THOSE EITHER BUT WE'RE TAKING UP A LOT OF SPACE WITH THEM BECAUSE THEY HAVE SOME GOOD IDEAS THAT PEOPLE COULD USE AND THE SAME IS TRUE FOR AT LEAST SOME OF THESE. IF WE TAKE OUT THE MODEL KEY INFORMATION SECTIONS, DO WE NEED TO KEEP IN ALL OF THOSE POWER POINTS AND STUFF? >> WHAT WE ENDED UP IS TOOL 1, THE LIST OF QUESTIONS, REALLY TOOK THE BEST OUT OF THOSE. SO I ACTUALLY DON'T HAVE ANY ISSUES TAKING EITHER OF THOSE OUT. >> JUST HAVE THE ONE APPENDIX OF QUESTIONS. >> I DIDN'T THINK THE INFORMATION GRID REALLY ADDED ANYTHING TO A LIST OF QUESTIONS. >> RIGHT. >> THAT SOUNDS GOOD TO ME. >> YEAH, THAT WOULD BE FINE TO ME TO TAKE THEM OUT. WE HAVE LOTS OF PEOPLE PRESENT TO SACHRP, WE DON'T BUNDLE, IT'S NOT LIKE WE'RE UPSTARTING A PRECEDENT. IT SOLVES THE CONSENT FORM PROBLEM, WHETHER SACHRP WANTS TO SAYING SOMETHING ABOUT HOW THE LARGER COMMUNITY SHOULD BE WORKING COLLABORATIVELY TO DEVELOP TOOLS AROUND THIS, WHETHER IT'S CALLING OUT GROUPS LIKE ANYBODY IN THIS SPACE, CTTI, WHATEVER, I MEAN I DON'T KNOW HOW THAT CALL WILL BE RECEIVED BUT IF WE WERE LOOKING TO CALL OUT PEOPLE AS POTENTIAL PARTNERS IN THIS, THOSE ARE SOME OF THE USUAL SUSPECTS THAT I THINK IT WOULD BE WITHIN THEIR MISSION TO DO JUST THAT. SO WE COULD IN THE CONCLUSION SAY SOMETHING ABOUT THESE COMPONENTS OF THE IRB COMMUNITY, THE PRIMERS, AHARPS, WHOMEVER, SHOULD BE ENCOURAGED TO -- >> PART OF THE IDEA WE DON'T NEED NECESSARILY EVERY INSTITUTION TO BE A LONE WOLF DOING THIS ON THEIR OWN, THEY OUGHT TO LEARN FROM ONE ANOTHER, FACING MORE CHALLENGES AND TO THE EXTENT THAT THERE ARE ALREADY COMMUNITIES OF IRB DIRECTORS, THINGS OF THAT NATURE, THAT THOSE ENTITIES, I'M TRYING TO THINK OF THE BROAD PHRASE WE WANT TO REFER TO PRIMER AND AHARP, AND AAMC AND OTHERS, RIGHT? THOSE ARE THE SORTS OF ENTITIES THAT SHOULD FACILITATE THOSE EFFORTS, THAT'S THE GIST. >> YEAH, ORGANIZATIONS THAT ARE PART OF THE DEVELOPMENT OF HUMAN RESEARCH PROTECTION PROGRAMS AND GENERAL PROTECTION OF HUMAN SUBJECTS. >> IT'S ALSO SPONSORS AND INSTITUTIONS. THERE'S A LOT OF WORK GOING ON IN THIS EVERYWHERE. WE DON'T WANT PEOPLE TO THINK SACHRP IS THE FINAL ANSWER. PARTICULARLY WHEN WE'RE DOWN TO SIX PEOPLE IN A MEETING. >> BEST OF THE BEST. >> WE MAKE GREAT RECOMMENDATIONS, BUT THEY ARE GENERAL, I'M NOT COMFORTABLE RECOMMENDING THE FIVE SUBMITTED TO US. >> YEAH. >> SO I THINK IN CONCLUSION WE JUST DO WANT TO SAY FURTHER ENCOURAGEMENT THAT THE REGULATED COMMUNITY WORK TOGETHER. >> YEAH. >> AND TAKE ADVANTAGE OF EFFORTS ONGOING IN THE REGULATED COMMUNITY. >> OKAY. >> HAVEN'T WAITED FOR US TO ENCOURAGE THEM. >> I CAN ADD SOMETHING BECAUSE I'M GOT A NUMBER OF CLEANUPS TO DO ANYHOW. >> THAT LAST SENTENCE, WE HOPE THAT THEY WILL TAKE FULL ADVANTAGE BUT ALSO WORK TOGETHER TO SHARE RESOURCES AS -- YOU KNOW, SOMETHING LIKE THAT, THAT COULD BE THE END OF THAT LAST SENTENCE. >> OKAY. I'LL PLAY AROUND WITH IT. >> DAVID, WOULD IT BE ACCEPT ACCEPTABLE, THE LAST SEVEN IS REASONABLE AVAILABLE, COULD YOU CLEAN THIS UP WHILE DOING THAT AND BRING THIS BACK. >> THIS CAN COME BACK TOMORROW. SHOULDN'T TAKE LONG. >> SO WE HAVE A HARD STOP TOMORROW BECAUSE WE LOSE QUORUM AT 2:30. AND THIS IS REALLY THE TWO DOCUMENTS WE'VE DISCUSSED SO FAR TODAY, I THINK, ARE THE PRIORITY FOR THIS MEETING BECAUSE THEY ARE ALL RELATED TO THE TRANSITION. SO I GUESS THAT'S RIGHT. IF YOU COULD BRING THIS BACK FIRST THING IN THE MORNING, AND WE COULD FINALIZE IT OR ATTEMPT TO DO SO. >> ALL RIGHT. >> THANK YOU. >> AND NOW BACK TO YOUR PLAYBILLS, I'LL BE THE UNDERSTUDY FOR MICHELE RUSSELL-EINHORN WHO CONVENIENTLY GOT OUT OF PRESENTING THIS AFTERNOON. [LAUGHTER] IT'S MY PLEASURE TO PRESENT THIS FOR MICHELE. THIS DOCUMENT AGAIN WE HAD A DISCUSSION ABOUT THIS BACK AT THE MARCH SACHRP MEETING. IT WAS FURTHER REFINED AND BEEN REVIEWED BY THE SUBCOMMITTEES, AND WE FELT PRETTY GOOD ABOUT WHERE IT IS AT AT THIS POINT. DO I HAVE THE WRONG ONE UP? I CANNOT HANDLE THIS ONE RIGHT NOW. YEAH, HOLD ON. THAT'S A NO. HOLD ON. I'VE GOT LIKE THREE DIFFERENT FOLDERS HERE. REASONABLE AVAILABLE, OKAY. LET'S TRY THIS ONE. SO WE HAVE THE REASONABLY AVAILABLE WHICH DEALS WITH ISSUES OF PARENTAL PERMISSION AND RESEARCH INVOLVING CHILDREN. AND YOU'LL RECALL FROM THE LAST MEETING THAT THIS DOCUMENT STARTS WITH SOME OF THE BACKGROUND, SUBPART D, AND THE REQUIREMENTS FOR OBTAINING PERMISSION FROM EITHER ONE PARENT OR GUARDIAN OR BOTH PARENTS, DEPENDING ON THE LEVEL OF RISK ASSIGNED TO THE STUDY AND WHETHER IT FITS IN THE FOUR CATEGORIES OF APPROVABLE RESEARCH UNDER THE SUBPART. SO THE FIRST PARAGRAPH LAYS OUT THE REGULATORY BACKGROUND. AND THE SECOND PARAGRAPH CONTINUES ON TO TALK ABOUT THE REQUIREMENT, SO THE FIRST SETTING THE CATEGORY OF THE RESEARCH, SECOND PARAGRAPH IS ABOUT THE REQUIREMENTS FOR PARENTAL PERMISSION, BASED ON ASSIGNED LEVEL OF RISK AND THIRD PARAGRAPH BRINGS UP THE QUESTION THAT IRBs AND INVESTIGATORS EXPRESSED CONFUSION ABOUT THIS TERM, REASONABLY AVAILABLE, WHICH AS YOU CAN SEE IN THE PARAGRAPH BEFORE IS IN THE REGULATION. THE REGULATION SAYS IF PERMISSION IS TO BE OBTAINED FROM PARENTS, PERMISSION MUST BE OBTAINED FROM BOTH UNLESS ONE IS DECEASED, UNKNOWN, INCOMPETENT OR NOT REASONABLE AVAILABLE. IT'S THAT "OR NOT REASONABLE AVAILABLE" THAT CAUSED CONFUSION IN THE REGULATED COMMUNITY AND DOCUMENT GOES ON TO SAY STARTING AT LINE 37 THAT THE INTERPRETATION OF NOT REASONABLY AVAILABLE HAS BEEN QUITE VARIABLE ACROSS IRBs AND RESEARCHERS. AND NOTES IN THE MIDDLE OF LINE 45 THE IRB CAN BE CONSULTED FOR GUIDANCE ON A SITUATION IT'S ULTIMATELY THE RESPONSIBILITY OF THE INVESTIGATOR TO ASSESS DOCUMENT AND DECIDE WHETHER A PARENT IS NOT REASONABLY AVAILABLE GIVEN THE FACTS. AND THEN DOWN AT LINE 51 WHEN THE IRB REQUIRES THAT PERMISSION BE PROVIDED BY TWO PARENTS, BOTH PROVIDE PERMISSION, NO ISSUE. THE PROBLEM ARISES WHEN BOTH PARENTS ARE KNOWN AND COMPETENT AND HAVE LEGAL RESPONSIBILITY FOR THE CHILD BUT PERMISSION OF THE SECOND PARENT IS NOT OBTAINABLE, AND HERE THE ABSENCE OF PERMISSION COULD BE BECAUSE THE SECOND PART, ONE, DOESN'T WANT TO PARTICIPATE IN CONSENT PROCESS, TWO IS NOT REASONY AVAILABLE, OR THREE IS AVAILABLE BUT NOT REASONABLY AVAILABLE IN TERMS OF PROVIDING DOCUMENTATION, THE SIGNATURE. SO THIS RECOMMENDATION IS GOING TO PROVIDE GUIDELINES HOW TO DETERMINE WHETHER A PARENT IS NOT REASONABLY AVAILABLE, AND ON MANAGING SITUATIONS WHERE THE ISSUE IS REALLY ABOUT DOCUMENTATION MORE THAN BEING REASONABLY AVAILABLE TO ENGAGE IN THE PERMISSION PROCESS. QUESTIONS SO FAR? THIS IS BACKGROUND THAT SHOULD BE PRETTY STRAIGHTFORWARD. SECTION 2 REVIEWS EXISTING GUIDANCE IF NOT REASONABLY AVAILABLE. IT NOTES LINE 79 THAT THIS TERM IS NOT DEFINED IN REGULATION OR IN GUIDANCE. AND REPEATS THERE ARE VARYING IRB INTERPRETATIONS THAT RESULT IN EITHER ABILITY TO MORE EASILY ENROLL CHILDREN WITH ONE PARENT'S PERMISSION OR MORE STRINGENT THAT IMPOSE MORE LIMITS ON ABILITY TO ENROLL CHILDREN IN RESEARCH. SINCE SUBPART D WAS DEVELOPED, CONCEPT HAS BEEN AFFECTED BY ADVENT OF NEW FORMS OF COMMUNICATION, THAT CAN LEAD TO MORE EASILY REACHING AND COMMUNICATING WITH A PARENT, THINK SKYPE OR CELL PHONES. SO PEOPLE THAT IN THE PAST WHO MIGHT NOT HAVE BEEN READILY AVAILABLE FOR DISCUSSION NOW ARE, BUT WHILE THE TOOLS ENABLE COMMUNICATION DOCUMENTATION IS MORE DIFFICULT. SO SECTION 3 WE PRESENT OVERARCHING PRINCIPLES. >> DAVID, GO BACK. ENABLE COMMUNICATIONS -- (INAUDIBLE). >> YOU'RE RIGHT, THIS PARAGRAPH DOES NOT. SORRY, YEAH, I THINK I SNIPPED THAT OFF IN MY SUMMARY. OKAY. SO WE HAVE OVER ARCHING PRINCIPLES IN THE THIRD SECTION, NOTING RESEARCHERS HAVE TO BE SENSITIVE TO THE VARIABILITY OF CONFIGURATIONS AND EXPERIENCES OF FAMILIES IN MAKING DETERMINATIONS ABOUT SECOND PARENT AVAILABILITY, CALLING OUT THE FACT THAT IN CASES LIKE DOMESTIC VIOLENCE OR ABANDONMENT MAY BE ININAPPROPRIATE AND RESEARCHERS MAY NEED TO INQUIRE ABOUT PARENTAL RELATIONSHIP INCLUDING WHETHER TWO PARENTS LIVE IN THE HOME OR ARE OTHERWISE INVOLVED IN THE CHILD'S LIFE MAKING EVALUATION AND IN DOING SO HAVE TO RELY ON INFORMATION PROVIDED BY ONE PARENT. SO WE'VE GOT THREE BULLETS THAT ARE THE OVERARCHING PRINCIPLES, ONE WHEN AN IRB DETERMINES THE PERMISSION OF BOTH PARENTS IF REASONABLY AVAILABLE IS REQUIRED, PERMISSION PROCESS WITH EACH PARENT CAN OCCUR INDEPENDENTLY SO THEY DON'T HAVE TO BE IN THE SAME ROOM AT THE SAME TIME. AND BY DIFFERENT METHODS PRIOR TO INVOLVEMENT OF THE CHILD IN RESEARCH. WHEN CHILDREN ARE IN THE SHARED LEGAL CUSTODY OF TWO PARENTS OR GUARDIANS EACH RIGHT OF DECISION MAKING IS TO BE RESPECTED, IF ONE PARENT AGREES TO BE CONTACTED AND DECLINES TO GIVE PERMISSION, IN OTHER WORDS AFFIRMATIVELY SAYS NO TO PARTICIPATION BY THE CHILD IN RESEARCH, THAT DOES NOT MEAN THE PARENT IS NOT REASONABLY AVAILABLE, IT MEANS THE PART HAS DECIDED NOT TO PROVIDE PERMISSION AND THE CHILD SHOULD THEREFORE NOT BE ENROLLED. THIRD BULLET, THE TERM REASONABLY AVAILABLE SHOULD BE APPLIED TO, ONE, LOCATING A A PARENT, TWO, MECHANISM USED TO SECURE THE PERMISSION, FOR EXAMPLE PARENTS MAY BE REASONABLY AVAILABLE BECAUSE THEY HAVE BEEN LOCATED BUT THERE MAY BE NO REASONABLY AVAILABLE MECHANISM TO OBTAIN THE SECOND PARENT'S SIGNATURE ON A PERMISSION FORM. >> DO WE REALLY NEED THE THIRD BULLET? ISN'T THAT -- I MEAN WHO WOULD SAY THAT SIMPLY LOCATING SOMEONE MAKES THEM REASONABLY AVAILABLE? IT DOESN'T SAY YOU KNOW WHERE THEY ARE. IT SAYS REASONABLY AVAILABLE. I DON'T KNOW, DO OTHERS NOT FEET . - FEEL -- >> IF YOU LOCATED BUT THEY COULDN'T SIGN. IF THEY COULDN'T GIVE PERMISSION BUT YOU KNEW WHERE THEY WERE, RIGHT? OKAY. I SEE WHAT YOU'RE SAYING, THAT'S JUST OBVIOUS THEN. >> IF YOU KNOW WHERE THEY ARE BUT YOU CAN'T COMMUNICATE WITH THEM OBVIOUSLY THEY ARE NOT REASONABLY AVAILABLE. DOESN'T MATTER IF YOU KNOW WHERE THEY ARE. IT'S NOT REASONABLY LOCATABLY, IT'S REASONABLY AVAILABLE. >> SO YOU KNOW WHERE THEY ARE, YOU KNOW HOW TO REACH THEM, LIKE YOU HAVE THEIR TELEPHONE NUMBER OR YOU HAVE THEIR E-MAIL ADDRESS OR SOMETHING LIKE THAT. >> NO, IF YOU KNOW HOW TO REACH THEM, YEAH, IN PRISON, IF YOU HAVE THEIR CELL PHONE NUMBER YOU CAN CALL THEM. >> BUT, NO, THAT BULLET WAS SUPPOSED TO BE TWO PARTS.. >> THAT'S THE LEAD-IN FOR THE SECTION THAT TALKS ABOUT HOW YOU MAY BE ABLE TO GET PERMISSION FROM SOMEONE, BUT THEY ARE NOT ABLE -- RIGHT? THEY ARE NOT ABLE TO ACTUALLY PROVIDE A SIGNATURE. I THINK IT'S JUST A SUMMARY STATEMENT THAT THAT INTRODUCES THE CONCEPT. >> WHAT'S THE HEADER? >> OVERARCHING PRINCIPLES IS THE HEADER. >> IT KIND OF LIKE SETS OUT HERE IS WHAT WE'RE GOING TO TALK ABOUT. I MEAN -- >> THAT'S FINE, IT'S NOT SOMETHING I'M GOING TO MAKE A FUSS ABOUT. >> I THINK THE REASON IS BECAUSE THERE'S A WHOLE SECTION THAT RELATES TO IT SO IT'S A PLACE TO INTRODUCE IT AS A TOPIC. >> MAYBE IT DOESN'T NEED TO BE A BULLET BUT BECOMES ITS OWN PARAGRAPH, LIKE THE BULLETS ARE THE PRINCIPLES AND THEN THE NEXT PARAGRAPH -- THAT'S STILL MINOR BUT THAT MIGHT BE A WAY TO CLARIFY. >> CAN I CLARIFY IF YOU KNOW WHERE A PARENT IS BUT THEY ARE NOT RESPONDING TO YOU AT ALL, YOU KNOW THEORETICALLY WHERE THEY ARE BUT DON'T KNOW HOW TO REACH THEM THEY ARE NOT REASONABLY AVAILABLE. IF YOU KNOW HOW TO REACH THEM AND THEY ARE SIMPLY NOT RETURNING YOUR CALLS, YOU HAVE THEIR PHONE NUMBER, YOU'RE PRETTY SURE YOU HAVE IT AND HAVE THEIR E-MAIL ADDRESS AND YOU HAVE THESE MECHANISMS FOR REACHING THEM AND THEY ARE NOT RETURNING YOUR CALL, THEN I WOULD SAY THEY ARE REASONABLY AVAILABLE BUT NOT WILLING TO ENGAGE WITH THE PERMISSION PROCESS SO WOULD YOU SAY THAT MEANS THAT ONE PARENT CAN GIVE PERMISSION OR THAT THAT KID CAN'T PARTICIPATE IN THE STUDY? >> IT'S FACT BASED. IF YOU GO TO THE PREVIOUS PAGE, ONE PARENT IS UNWILLING TO ENGAGE IN THE CONVERSATION, THAT'S NOT A YES OR NO. AND I THINK THAT -- SO IT WILL ALL COME DOWN IN THE END TO HOW THE INVESTIGATOR INTERPRETS THAT. >> BUT WE'RE GIVING GUIDANCE HOW TO INTERPRET THAT. WHAT GUIDANCE ARE WE GIVING? >> IF A PARENT WON'T ENGAGE, SO AFFIRMATIVELY SAYS THAT -- NOT BECAUSE THEY DON'T WANT THE CHILD TO PARTICIPATE BUT I DON'T WANT TO HAVE ANYTHING TO DO WITH THE CHILD'S FATHER AND THE CHILD, THEY ARE GONE, OR THE CHILD'S MOTHER, I'M NOT INVOLVED, DON'T CALL ME AGAIN, I THINK IN MANY CIRCUMSTANCES, IF NOT ALL, YOU WOULD CONSIDER THAT PERSON NOT REASONABLY AVAILABLE AND WOULDN'T HOLD THE CHILD'S WHO IS NOT FUNCTIONING AS A PARENT. BUT THAT'S A PERSONAL -- THAT'S JUST HOW I WOULD SEE IT. >> I SEE IT AS ANALOGOUS TO REFUSAL WHERE YOU MAKE -- IN OUR SHOP WE MAKE A DISTINCTION BETWEEN INFORMED REFUSAL AND UNINFORMED REFUSAL. IF YOU CALL SOMEONE ON THE PHONE, LISTEN TO THE STUDY PITCH, THEY SAY NO, THEY HAVE MADE AN INFORMED REFUSAL, YOU DON'T CALL THEM AGAIN. IF THEY SAY I'M BUSY RIGHT NOW, BAM, OR I DON'T DO STUDIES, BAM, YOU CALL THEM AGAIN AT A DIFFERENT TIME. AND MAKE YOUR PITCH. OR ATTEMPT TO MAKE YOUR PITCH. HERE I MEAN I THINK PART OF IT IS WERE YOU ABLE TO REACH THIS PARENT IN SOME WAY AND TELL THEM WHAT YOU WERE ON ABOUT, IF YOU DID AND THEY ARE NOT RESPONDING I WOULD SAY THAT KID CAN'T PARTICIPATE IN THE STUDY. >> I THINK THAT LATER ON IN THE DOCUMENT WE TALK ABOUT THAT. THERE'S NO REASON -- UNLESS THERE'S TIME CRITICAL - -- AND INTERVENTION THAT'S TIME CRITICAL THAT YOU SHOULD TRY AGAIN BUT WE ALSO HAVE THIS NUMBER 1 WHERE THERE ARE PARENTS WE CAN ANTICIPATE WON'T WANT TO BE REACHED AND DON'T WANT TO DISCUSS IT WITH YOU. >> BACK TO WHERE WE WERE, HOLLY HAD THE SUGGESTION OF DEBULLETTING THE THIRD ONE AND MAKING IT A STAND-ALONE THING WHICH I'M HAPPY TO DO. I'M GOING TO TURN THIS OFF FOR A SECOND SO THE TRACKING DOESN'T GO WILD. >> IT'S A DEFINITION, NOT A PRINCIPLE. >> DOES THIS HAPPEN RELATIVELY OFTEN FOR PEOPLE IN THE MILITARY, AS ONE EXAMPLE? >> YES. THAT'S ONE THING. >> DID SOMEBODY SAY I SHOULD MOVE THIS PARAGRAPH? >> GO ABOVE THE BULLET. >> IT NEEDS NATURALLY INTO FOUR. >> LET'S LEAVE IT, IF WE THINK SECTION 4 IS APPLICATION OF REASONABLY AVAILABLE TO LOCATING A PARENT. HERE WE'RE SAYING IF A PARENT'S ROLE IN THE CARE OF AND/OR DECISION MAKING ABOUT THE CHILD, EVEN IF LIMITED, IS SUCH THAT HIS OR HER INVOLVEMENT AND LOCATION MAY BE READILY ASCERTAINED, THEY ARE REASONABLY AVAILABLE, YOU HAVE TO TRY TO CONTACT THEM. NOT REASONABLY AVAILABLE IS NOT INTENDED TO MEAN TEMPORARILY UNAVAILABLE, UNLESS THERE ARE SPECIFIC CIRCUMSTANCES WHERE TIME IS OF THE ESSENCE. STEPHEN, YOU WERE JUST TALKING ABOUT THAT, SOME FACTS THAT MIGHT PLAY INTO THE DECISION. THERE ARE NUMEROUS SPECIFIC SITUATIONS THAT COULD SUPPORT A DETERMINATION THAT A PARENT IS NOT REASONABLY DEVELOP, IN GENERAL IT'S ONE WHOSE WHEREABOUTS ARE UNKNOWN, WHO SHOULD NOT BE CONTACTED BECAUSE THE NATURE OF THE RELATIONSHIP BETWEEN THE PARENT AND CHILD, WHOM THERE'S NO WAY TO REACH BY PHONE, MAIL, E-MAIL, FAX OR ANY TYPE OF VIDEO CONFERENCES, OR CONTACT ATTEMPTS, AND THERE'S A FOOTNOTE AT THE BOTTOM SAYING IT'S GOING TO BE CONTEXTUAL. NOT REASONABLY AVAILABLE DOES NOT APPLY TO SITUATIONS WHEN A PARENT IS AT WORK, TRAVELING, NOT IMMEDIATELY AVAILABLE BY ELECTRONIC MEANS OR LIVING IN ANOTHER STATE OR COUNTRY WITHOUT MORE TO JUSTIFY THE INVESTIGATOR'S ABILITY TO REACH THE PARENT AND SEEK PERMISSION. WE HAVE SOME EXAMPLES OF SITUATIONS WHERE WE WOULD CONCLUDE THAT SOMEBODY IS NOT REASONABLY AVAILABLE. THE PARENT IS INCARCERATED AND NOT CONTACTABLE. THE PARENT IS ON ACTIVE MILITARY DUTY AND NOT CONTACTABLE. THE PARENT'S WHEREABOUTS ARE UNKNOWN. THE PARENT IS KNOWN AND CONTACTABLE BUT UNINVOLVED IN THE CHILD'S CARE. THE PARENT IS KNOWN BUT UPON INQUIRY THERE IS NO REASON TO BELIEVE THAT REQUESTING PERMISSION WOULD BE INCONSISTENT WITH THE PARENT-CHILD RELATIONSHIP SUCH AS WHERE THERE IS REASON TO BELIEVE THERE IS OR HAS BEEN DOMESTIC VIOLENCE OR OTHER SITUATIONS INVOLVING HARM TO THE HEALTH OR WELFARE OF THE CHILD. THE PARENT HAS BEEN CONTACTED AND HAS ACTIVELY DECLINED TO PARTICIPATE IN THE PERMISSION PROCESS, IN THIS SITUATION THE PARENT IS REFUSING TO PARTICIPATE IN THE PROCESS ENTIRELY. THIS IS DIFFERENT FROM DECLINING TO PROVIDE PERMISSION. THAT IS SAYING NO, THE CHILD SHOULD NOT PARTICIPATE IN RESEARCH. >> I'M BOTHERED BY THE FOURTH BULLET, KNOWN CONTACTABLE BUT UNINVOLVED. WE'VE ALREADY TAKEN OFF THE CIRCUMSTANCE WHERE THEY DON'T HAVE CUSTODY. >> RIGHT. >> SO WHO MAKES THE DECISION? THAT SEEMS A LITTLE BIT THIN ON CRITERIA TO ME. >> I THINK IT GOES BACK TO THE COMMENTS MADE EARLIER ABOUT FAMILY SITUATIONS MAY BE COMPLICATED. I MEAN, I THINK THE CRITICAL ISSUE IS THAT THE IRB MAKES A DETERMINATION THAT GENERALLY FOR THIS TYPE OF RESEARCH UNDER REVIEW, TWO PARENTS SHOULD PROVIDE THEIR PERMISSION. BUT WHAT THIS IS SAYING, MORE REASONABLY AVAILABLE SAYS THERE ARE CERTAIN CIRCUMSTANCES WHEN THAT SECOND PARENT IS NOT REASONABLY AVAILABLE AND THE ISSUE AND I THINK LESLIE RAISED THIS VERY ARTICULATELY DESCRIBED HOW EVEN IF THERE'S A PARENT WHO HAS LEGAL OR JOINT CUSTODY THERE MAY BE DIFFICULT FAMILY CIRCUMSTANCES AND THERE IS THIS FUNKY SENTENCE THAT SAYS IF YOU WANT TO GO BACK, DAVID, SOME SENTENCE THAT TALKS ABOUT, YOU KNOW, THE INVESTIGATOR'S RESPONSIBILITY TO FIGURE OUT WHAT THE FAMILY RELATIONSHIP IS. >> I AGREE WITH ALL OF THAT. IT'S JUST SIMPLY TO DESCRIBE IT AS THE PARENT IS KNOWN BUT ININVOLVED SEEMS REALLY LIKE COMPLETELY SUBJECTIVE AND POTENTIALLY SUBJECT TO MANIPULATION FOR THE SAME PROBLEMATIC FAMILY REASONS THAT YOU ALREADY MENTIONED. I'M NOT TALKING ABOUT ABUSE BUT A DIFFICULT REPORT, IT DOESN'T TAKE AWAY RIGHTS BECAUSE THEY ARE NOT SPEAKING TO ONE ANOTHER. >> YOU CAN TAKE IT OUT, ITS MAY BE INAPPROPRIATE OR DISRESPECTFUL TO SOLICIT CONSENT FROM THE SECOND PARENT, I'M ASSUMING IT MEANS BOTH HAVE LEGAL CUSTODY. WHAT THAT SAYS IS WHAT THAT BULLET SAYS, YOU CAN CONTACT BOTH PEOPLE BUT YOU'RE MAKING A DETERMINATION BASED UPON THE FAMILY SITUATION THAT IT'S NOT APPROPRIATE TO GO GET CONSENT. >> I MEAN, I FEEL LIKE IRBs DO THIS BECAUSE THEY FEEL THE RISK OF THE STUDY MERITS THIS LEVEL OF INVOLVEMENT. THAT SHOULD NOT BE TAKEN LIGHTLY. THERE ARE CLEARLY FAMILY SITUATIONS THAT WOULD JUSTIFY NOT CONTACTING THE OTHER PARENT. BUT I DON'T THINK THAT SENTENCE IS QUALIFIED ENOUGH. >> THIS SAYS EXAMPLES. YOU COULD TAKE IT OUT AND IT DOESN'T MEAN IT'S NOT A CONCEPT THAT MIGHT FALL UNDER THAT BUCKET. >> I'M OKAY IN THE CONTEXT OF THE REST OF THE DOCUMENT, WHAT IS UNDER THE -- WHAT WAS INCLUDED IN THE OVERARCHING PRINCIPLES AND DESCRIPTION OF FAMILY AND KINDS OF THINGS THAT OUGHT TO BE TAKEN INTO ACCOUNT, NOT HAVING IT HERE AS AN EXAMPLE I THINK IS FINE. >> I'M CURIOUS HAVE WE DISCUSSED THE LAST BULLET HERE, I'M JUST TRYING TO UNDERSTAND THAT -- RIGHT. THAT ONE. ARE WE DISCUSSING THAT? >> I CAN'T GET A NO AND PRESUME THEY WEREN'T ABLE. >> IT'S THE OPPOSITE. >> MAYBE I MISUNDERSTOOD. >> YOU CALL ON THE PHONE, THEY SAY -- THEY DON'T SAY NO, THEY SAY NO, I DON'T WANT TO MAKE THIS DECISION AND BE PART OF THIS DECISION-MAKING PROCESS. >> TO GO TO THE LAST -- >> THE PARENT IS NOT REASONABLY AVAILABLE, AM I MISUNDERSTANDING, WHAT I WOULD GUESS WHY, GIVEN WHAT WE JUST DISCUSSED EARLIER, THE PREMISE OF THE RULE IS THAT BASICALLY YOU ARE GOING TO NEED BOTH PARENTS TO SAY YES, UNLESS, AGAIN, ONE OF THE PARENTS IS NOT REASONABLY AVAILABLE. SOUND LIKE THAT PERSON IS REASONABLY AVAILABLE, FOR WHATEVER THEY DON'T WANT TO SAY YES. IF THE RULE IS THAT -- >> BUT THEY ARE NOT REASONABLY AVAILABLE FOR PURPOSES OF MAKING THE DECISION BECAUSE THEY MADE THEMSELVES NOT AVAILABLE, RIGHT, MICHELE? >> THE ISSUE IS THEY ARE THOUGHT TALKING ABOUT THE SITUATION OF ENROLLING THE CHILD IN RESEARCH. THEY ARE LIKE I DON'T WANT TO TALK TO YOU. IT'S NOT LIKE -- IT IS LOOKING -- MAYBE WHAT YOU'RE SAYING, YOU'RE LOOKING AT REASONABLY AVAILABLE. >> IN TERMS OF STEPHEN'S POINT, THE STARTING PREMISE IS THAT BOTH PEOPLE, BOTH PARENTS SHOULD IN FACT SAY YES BEFORE YOU ENROLL THE CHILD. IF ONE -- I'M NOT ABOUT TO -- I WANT NOTHING TO DO WITH THIS STUDY, CERTAINLY FAR FROM CLEAR THAT THAT SHOULD BE VIEWED AS ESSENTIALLY THEY ARE OUT OF THE PICTURE, ALL YOU NEED IS A YES FROM THE OTHER ONE. >> GREATER THAN MINIMAL RISK. >> THERE'S SOME PREMISE -- >> WHAT'S THE DEFAULT OPTION? IS THE SITUATION IN A MORE THAN MINIMAL RISK STUDY UNLESS ONE OF THE PARENTS IS SIMPLY UNAVAILABLE. >> THE ISSUE IT'S NOT THAT THEY DON'T WANT TO SAY YES. THEY SAY YOU'RE CALLING ABOUT A RESEARCH STUDY, I HAVE NOTHING DO WITH THAT FAMILY ANYMORE, DON'T CALL ME AGAIN. >> THAT'S A DIFFERENT SCENARIO. I THOUGHT YOU COVERED THAT EARLIER. I GUESS IT SEEMS THAT LAST BULLET WAS SAYING SOMETHING DIFFERENT. THAT THEY MAY VERY WELL -- THAT'S A DIFFERENT POINT SAYING THEY HAVE NOTHING TO DO WITH TAKING CARE OF THE CHILD, YOU COVERED THAT POINT. HERE IT SEEMS TO BE ONE JUST DOESN'T WANT TO TALK TO YOU AT THAT POINT OR SOMETHING. I WANT NOTHING TO DO WITH THIS STUDY. >> I DON'T THINK THAT'S WHAT W MEAN. >> OKAY. >> I THINK WE NEED ON CLARIFY THAT. >> MORE ALONG THE LINES, THE FIRST SENTENCE OF IT, ACTIVELY DECLINED TO PARTICIPATE IN THE PROCESS, IF YOU NARROW IT -- WELL, MAYBE THAT DOESN'T REALLY HELP. >> I THINK WE DID MEAN THAT TO SAY THAT THERE ARE A NUMBER OF SITUATIONS WHERE YOU COULD HAVE TWO PARENTS, AND ONE SHOULDN'T BE CONSULTED BECAUSE THERE'S DOMESTIC ABUSE AND, YOU KNOW, THAT HAS NOT BEEN ADJUDICATEDDED TO TAKE AWAY CUSTODY, YOU MAY CONTACT THEM, THEY MAY SAY I DON'T WANT ANYTHING TO DO WITH THIS CONVERSATION, SHOULDN'T LIKE STEPHEN SAID HOLD THE KID HOSTAGE SO THE KID CAN'T BE ENROLLED IN RESEARCH. I DO BELIEVE THAT'S WHAT THE GROUP FELT AND CAN HEAR SUSAN SAYING AT BOSTON CHILDREN'S HOSPITAL THERE'S MANY SITUATIONS IT'S DIFFICULT TO GET CONSENT FROM A SECOND PARENT BECAUSE THERE'S FUNKY FAMILY CIRCUMSTANCES AND I THINK WE DID TAKE THE POSITION THAT IF YOU KNOW WHERE THEY ARE AND THEY DON'T WANT TO TALK TO YOU, NOT THAT THEY DON'T WANT TO GIVE PERMISSION BUT JUST DON'T WANT TO TALK TO YOU THAT WE'RE LOOKING AT THAT SITUATION AS THEY ARE NOT REASONABLY AVAILABLE FOR THE PURPOSE OF DISCUSSING PARTICIPATION IN THE RESEARCH. YOU MAY DISAGREE WITH THIS. I'M JUST TELLING YOU I THINK THAT'S WHAT WE SAID. >> THAT SOUNDS LIKE THE FOURTH BULLET, YOU'RE SAYING SOMETHING IN THE NATURE OF THE RELATIONSHIP THAT MEANS IT'S PROBLEMATIC TO CONTACT THIS PARENT OR NEED TO GET THEIR PERMISSION. BUT THE FIFTH BULLET IS JUST THAT THE PERSON DOESN'T WANT TO -- >> WON'T ENGAGE. >> YOU'RE SAYING THE OVERLAP BETWEEN BULLET 4 AND 5. >> THE LAST TWO BULLETS. >> THE LAST ONE. THE MERE FACT ONE OF THE PARENTS DOESN'T WANT TO TALK TO YOU I MEAN THEY JUST SAY I'M NOT GOING TO TALK TO YOU ABOUT THAT STUDY, IF THAT'S ALL YOU KNOW AND YOU HAVE PROBLEMS GETTING THEM IT TELL YOU ANYTHING, I WOULD HAVE THOUGHT THE STARTING PREMISE OF THE REQUIREMENT WAS THAT YOU SHOULD GET BOTH PARENTS, AGAIN, UNLESS WE'RE BACK TO WHAT THIS REASONABLY AVAILABLE MEANS. THE FACT THAT THEY DON'T WANT TO DISCUSS THE STUDY WITH YOU AGAIN ASSUMING THERE'S NOTHING INDICATING THIS IS A PARENT WHO DOESN'T TAKE CARE OF THE CHILD, HAS A BAD RELATIONSHIP, PARENT WHO DOES TAKE CARE OF THE CHILD, NO PROBLEM WITH THAT. IT'S THE NEXT TO THE LAST BULLET. BUT THE LAST BULLET SEEMS LIKE, I'M TRYING TO UNDERSTAND WHAT THAT WOULD MEAN, ASSUMING OHRP WAS TRYING TO IMPLEMENT THIS, I'M NOT UNDERSTANDING THAT LAST BULLET, THE MERE FACT THAT THE PARENT JUST -- I'M NOT GOING TO TALK TO YOU ABOUT THAT STUDY CAN MEAN A LOT OF THINGS, ASSUMING THAT MEANS THE PARENT IS NOT REASONABLY AVAILABLE SOUNDS LIKE CREATING TENSION, STARTING PREMISE THAT THIS TYPE OF STUDY STARTING PREMISE IS THAT BOTH PARENTS SHOULD BE SAYING YES, AGAIN, UNLESS THERE'S A REALLY GOOD REASON. >> IT COULD UNINTENTIONALLY OPEN A LOOPHOLE. >> PUT BACK FOUR, THE PARENT IS KNOWN AND CONTACTABLE BUT CHOOSES NOT TO BE INVOLVED IN THE CHILD'S CARE. IF THEY DON'T WANT TO TALK TO YOU, YOU DON'T KNOW WHAT IT MEANS, THEY COULD BE OPPOSED TO RESEARCH. BUT IF LEGAL STUFF HASN'T BEEN ADJUDICATED, THEY HAVE CUSTODY BUT SAY TALK TO THE MOM, TALK TO HIS MOM, I DON'T HAVE ANYTHING TO DO WITH THEM ANYMORE, I DON'T WANT TO BE PART OF THIS CONVERSATION, THEY ARE NOT SAYING I DON'T WANT TO TALK ABOUT THE STUDY OR BE IN RESEARCH, THEY ARE SAYING BASICALLY THIS IS A ONE-PARENT FAMILY AS FAR AS I'M CONCERNED. I DON'T KNOW THE RIGHT ANSWER. WE COULD ARGUE BOTH WAYS BUT THAT'S THE CIRCUMSTANCE WE WERE TRYING TO CAPTURE AND NEED TO BE CLEAR BECAUSE THE LANGUAGE IS AMBIGUOUS. >> I THINK THAT'S RIGHT, WHY WE HAD THE TWO BECAUSE WITH ONE ABOUT DOMESTIC VIOLENCE OR SOMETHING ELSE WAS YOU DON'T EVEN HAVE TO GO AND TRY TO COTACT THEM BUT THE OTHER IS YOU CALL AND SAY I DON'T MAKE ANY OF THOSE DECISIONS, TALK TO THE OTHER PARENT, THAT'S A DIFFERENT THING. SO I THINK STEPHEN IS RIGHT, IF WE CONNECT IT TO ONE WE TOOK OUT AND THAT PIECE OF IT THEN IT MAY HELP EXPLAIN AND NARROW IT. SO IT DOESN'T JUST SOUND LIKE I'M BUSY AT WORK, DON'T TALK TO ME KIND OF THING. >> THAT'S HELPFUL BECAUSE I WOULDN'T HAVE INTERPRETED IT THE WAY IT'S WRITTEN NOW AS BEING ANYTHING LIKE I'M SOMEHOW NOT INVOLVED WITH TAKING CARE OF THE CHILD IN THAT SORT OF THING BUT RATHER IT'S JUST THAT -- RIGHT, I'M NOT GOING TO TALK TO YOU AT THE MOMENT WHICH AGAIN WOULD BE HARD FOR ME IN TERMS OF OHRP IMPLEMENTING THESE THAT VIEW THAT AS A RATIONALE FOR THE CONCEPT OF REASONABLY AVAILABLE AND THE WHOLE SENSE THIS IS A PARENT WHO IS NOT INVOLVED WITH TAKING CARE OF THE CHILD. THE CURRENT WORDING OF THAT IN NO WAY ACTUALLY HINTS AT THAT. THEY SAID NO, I DON'T WANT TO TALK TO YOU ABOUT THAT. THAT WOULD CERTAINLY HELP. >> ONE QUESTION ABOUT THIS IS THE PARENT IS KNOWN AND CONTACTABLE BUT THEY SAY THEY ARE UNINVOLVED, YOU COULD END UP IN A SITUATION TALKING TO THE PART WHO IS WITH THE HOME, AND THAT PARENT IS SAYING THINGS ABOUT THE OTHER PARENT THAT MAY OR MAY NOT BE TRUE, YOU KNOW, LIKE THIS FATHER ISN'T DOING ANYTHING, HE'S NOT IN CHARGE, AND IN FACT IF YOU CONTACTED THE OTHER PARENT, THEY WOULD SAY QUITE THE OPPOSITE, THAT THEY ARE REALLY VERY INTERESTED IN THEIR CHILD AND CARE ABOUT THE CHILD BUT MOM OR FATHER IS KEEPING THEM FROM SEEING THE CHILD. THAT'S A PARENT WHO -- AGAIN YOU GET INTO THE WEIRD MANIPULATION SITUATION BETWEEN PARENTS, GRANDPARENTS, WHATEVER IS GOING ON BUT THE QUESTION I WORRY ABOUT HERE WHO DO YOU BELIEVE? IF YOU TALK TO A PARENT AND SAY, WELL, YOU SHOULDN'T GO AND CALL MY SPOUSE, THE OTHER PARENT, BECAUSE THEY HAVE BEEN ABUSING THIS CHILD, WELL, REALLY? THESE ARE AWKWARD SITUATIONS TO ADJUDICATE, WHAT'S THE SOURCE OF INFORMATION WE BELIEVE TO MAKE THIS DECISION. . >> THAT'S WHY I WAS UNCOMFORTABLE WITH ORIGINAL BULLET 4, BUT CHOOSES NOT TO BE IMPLIES THERE'S SOME INDICATION THAT IT'S NOT THE SAME CONVERSATION WHERE THE MOM OR DAD SAYS, WELL, MY SPOUSE HAS CHOSEN NOT TO BE, YOU'RE TRYING TO CONTACT, THEY CHOOSE NOT TO BE INVOLVED. AND THE ISSUE, THIS IS WHERE ULTIMATELY I THINK WE SAY THIS LATER, ULTIMATELY COMES DOWN TO THE INVESTIGATOR'S ASSESSMENT BECAUSE YOU CAN ABSOLUTELY SEE SITUATIONS WHERE EACH OF THESE THINGS COULD BE CLAIMED AS A REASON TO MANIPULATE THE DECISION-MAKING PROCESS, BUT YOU DON'T WANT TO -- THE CONTRARY, START INVOLVING PARENTS WHO ARE IN, YOU KNOW, SO YOU'RE SORT OF STUCK. I THINK REALLY THAT'S WHY THE IRB CAN'T DO IT. IT COMES DOWN TO THE INVESTIGATOR TALKING TO THE PARTICIPANTS OR THE PARENT AND MAKING AN ASSESSMENT AND THESE ARE THE THINGS THEY SHOULD CONSIDER, BUT NONE OF THEM ARE HARD AND FAST CRITERIA. I DON'T KNOW HOW WE CAN GET THAT ACROSS. DON'T WE SAY IT LATER? >> WE SAY IT AT THE BEGINNING. THERE'S ALSO THE PROBLEM IF YOU IMPLY TOO HIGH A STANDARD YOUR SYSTEMATICALLY DISADVANCING KIDS IN COMPLEX FAMILY SITUATIONS WHO CAN NEVER PARTICIPATE IN RESEARCH BECAUSE YOU'LL NEVER FIND BOTH PARENTS. IT'S A VERY MESSY PROBLEM. >> WE SHOULD BE CLEAR ABOUT WHAT SOURCE OF INFORMATION WE'RE WILLING TO TAKE, THE PARENT IS KNOWN AND CONTACTABLE BUT SAYS THEY DO NOT WISH TO BE INVOLVED BUT ONE PARENT SAYING DON'T CALL MY OTHER PARENT, HE OR SHE WON'T WANT TO DO THIS IS DIFFERENT. >> THAT'S THE OTHER THING THAT SUSAN SAID AT THE SUBCOMMITTEE, WE'RE TALKING ABOUT GREATER THAN MINIMAL RISK WITHOUT PROSPECT OF BENEFIT, THAT'S UNDERSCORING JERRY'S POINT, THE DEFAULT, YOU NEED TWO PARENTS BECAUSE IT'S NOT DIRECT BENEFIT SO MAYBE WE'RE STRANGE OURSELVES OUR -- STRAINING OURSELVES TO COME UP WITH CIRCUMSTANCES WHERE IT WOULD BE OKAY FOR ONE PARENT TO BE THE DECIDER. >> IT'S IMPORTANT IT REMEMBER THIS COMES UP AT LEAST WHAT WE SEE IN INDEPENDENT IRB WHERE THIS COMES UP IS PLACEBO-CONTROLLED PEDIATRIC CLINICAL TRIALS, ONE HARM IS DIRECT BENEFIT, THE OTHER IS PLACEBO, WITH WITHDRAWAL RISKS OR PROCEDURE RISKS, THAT HAVE TO BE DEEMED A MINOR INCREASE OVER MINIMAL RISK. CAN'T BE HIGH RISK OR KICKS INTO A 50-50 POUR. IT'S A VERY LIMITED CIRCUMSTANCE BUT DOES COME UP BECAUSE THERE MAY BE CT SCANS, BLOOD DRAW VOLUMES INVOLVED, AND THEY ARE BLINDED SO YOU CAN'T CHOOSE WHICH ARM TO PUT THEM ON. YOU'RE REALLY EXPOSING THE KIDS FOR WHOM YOU'RE GETTING TWO-PARENT SIGNATURES ARE EXPOSED TO MINOR INCREASE OVER MINIMAL RISK, IT'S NOT SUPPOSED TO BE SIGNIFICANT RISK. SO-- >> THAT DOES CHANGE THE ANALYSIS BECAUSE I KNOW THIS GETS INTO COMPONENT ANALYSIS AND ALL OF THAT BUT ON ONE HAND WE MIGHT SAY IT'S NOT THAT BIG OF A DEAL FOR EXCLUDING SOME KIDS BUT IN THE PRE-RANDOMIZATION STATE IT COULD BE. >> THE OTHER THING TO KEEP IN MIND WHEN REGULATIONS WERE ADOPTED, WHERE WE ARE NOW IN TERMS OF THE WAYS FAMILIES ARE CREATED, AND THE WAYS THAT FAMILIES ARE IN A VARIETY OF WAYS, AND SO I THINK YEAH, IT CAN'T JUST BE WE TOTALLY GET AROUND THIS BUT ALSO HAS TO RECOGNIZE THAT THERE ARE MANY, MANY MORE FAMILIES FOR WHICH THERE WILL BE ONE PARENT, OR IT WILL BE MUCH HARDER TO FIND -- AND SO YOU ARE AT SOME POINT GOING TO HAVE TO -- WE SAY WE PUT AN OBLIGATION ON RESEARCHERS TO INQUIRE ABOUT THOSE RELATIONSHIPS AND PROVIDE SOME IDEAS OF WHAT ONE MIGHT ASK BUT ULTIMATELY RECOGNIZE YOU HAVE TO TRUST THE PERSON THAT'S IN FRONT OF YOU. WE'RE NOT GOING TO ASK THEM TO GO OFF AND DO INDEPENDENT RESEARCH TO FIND WHETHER THIS PARENT IS ACTUALLY THERE. >> MAYBE WE SHOULD OHRP TO REQUIRE ONE PARENT'S SIGNATURE. THIS IS THE REGULATION. I THINK YOU'RE ABSOLUTELY RIGHT, LESLIE. I COMPLETELY AGREE BUT THIS IS THE REGULATION. >> SO THE OTHER ALTERNATIVE IS WHEN WE'RE DONE WITH THIS DOCUMENT WHICH WE STARTED DOWN A PATH ABOUT, I THINK AT THE LAST MEETING I THINK IT WAS THE LAST MEETING, IT WAS -- I GOT THE SENSE WHAT WE WERE REALLY BEING ASKED BUT IT WAS TOO LATE TO CHANGE WAS WHETHER COMPONENT ANALYSIS AT THAT LEVEL FOR THAT PARTICULAR QUESTION WAS THE APPROPRIATE APPROACH. AT THAT POINT WE ALREADY SPENT, I DON'T KNOW HOW LONG ON THIS, AND WE RAISED ISSUES PEOPLE WANTED ARTICULATED. I'M HOPING WE DO THIS AND THEN WE CAN ACTUALLY GET TO THE QUESTION BECAUSE AS HOLLY POINTED OUT, THE ISSUE HERE IS NOT -- IT'S NOT ABOUT GREATER THAN MINIMAL RISK STUDIES OR MINOR INCREASE, IT'S ABOUT KIDS THAT SUSAN IS SEEING AT BOSTON CHILDREN'S FOR WHOM IT IS A THERAPEUTIC TRIAL, AND YOU'RE NOT INCLUDING THEM, YOU'RE DEPRIVING THEM OF THE OPPORTUNITY OF DIRECT BENEFIT AMONG OTHER THINGS, AND WE CAN TALK ABOUT THERAPEUTIC MISCONCEPTION SOME OTHER TIME BUT IT'S NOT SO MUCH ABOUT THE RISK OF THE KIDS WHO GET THE PLACEBO, NOT ALLOWING THEM THE OPPORTUNITY TO PARTICIPATE IN THE STUDY WHICH IS POTENTIALLY BENEFICIAL TO THEM. >> JERRY RAISED A GOOD POINT ABOUT THE LAST BULLET. CAN WE GET RID OF THE LAST BULLET AND HAVE THE FOURTH BULLET WITH THE INCLUSION OF INCLUSION WORDS THAT CHOOSES NOT TO BE INVOLVED, IT WASN'T THAT THEY SAID LEAVE ME ALONE IT WAS AFFIRMATIVE I DON'T WANT ANYTHING TO DO WITH THAT WHICH SHOULD BE AFFIRMATIVE I DON'T WANT TO BE INVOLVED IN THIS CHILD'S CARE, THE SECOND WAS SOMETHING INCONSISTENT WITH THE RELATIONSHIP. IF WE HAVE THOSE TWO BULLETS WE CAPTURE THE SITUATION. I AGREE, I DON'T THINK WE MEANT IT TO BE THE PERSON'S BEING A PAIN IN THE NECK. THAT WASN'T WHERE THE GROUP WAS GOING. >> YEAH, I'VE GOTTEN RID OF THAT BULLET AND PUT THE INITIAL CHANGE TO THE FOURTH BULLET, SANDRA HAD SLIGHTLY BETTER WORDING THAT MADE IT CLEAR WHO THE SOURCE OF THAT INFORMATION WAS BUT THE IDEA IS HERE THAT YOU'VE GOTTEN HOLD OF THE SECOND PARENT AND THEY'VE SAID I'M NOT ENGAGING IN THIS, I HAVE NOTHING TO DO WITH THIS CHILD. I'M NOT GOING TO BE PART OF THAT. WE'LL CLEAN THAT UP. OKAY. SECTION 5, A DETERMINATION THAT A PARENT IS NOT REASONABLY AVAILABLE MAY INCLUDE CIRCUMSTANCES WHICH A PARENT IS AVAILABLE TO PARTICIPATE IN THE PROCESS AND GIVE PERMISSION FOR THE PARTICIPATION BUT NOT ABLE TO PROVIDE LEGALLY EFFECTIVE VALID SIGNATURE ON THE DOCUMENT. PROVIDE A SIGNATURE MUST NOT BE USED AS A REASON NOT TO INVOLVE THE PARENT IN CONSENT PROCESS OR REASON NOT TO RESPECT THAT PARENT'S DECISION. HOWEVER, THAT PARENT'S INABILITY TO PROVIDE A SIGNATURE OR OTHER ACCEPTED FORM OF PERMISSION IN WRITING CONFIRMING THE DECISION TO PERMIT THE CHILD TO ENROLL IN THE RESEARCH WOULD BE ACCEPTABLE UNDER THE REGULATIONS AS AN APPLICATION OF THE NOT REASONABLY AVAILABLE CRITERION AND THUS NOT REQUIRE A WAIVER OF DOCUMENTATION OF INFORMED CONCEPT, THIS PERMITS RECOGNIZES IMPORTANCE OF OBTAINING PERMISSION FROM BOTH IF AVAILABLE WITHOUT VIOLATING 117C INVOLVING GREATER THAN MINIMAL RISK RESEARCH. >> WE NEED TO SEE IF YOU FOUND SOMEBODY AND CAN ENGAGE WITH THEM ABOUT THE DECISION FOR THEIR CHILD, AND THEY SAY NO, THEN YOU ABIDE BY THAT DECISION REGARDLESS OF WHETHER THEY CAN SUPPLY THE SIGNATURE OR NOT. >> WE SAID THAT MULTIPLE TIMES. >> THIS IS THE OPPOSITE. >> AND BECAUSE THE SITUATION IS THIS REMINDS ME OF BROAD CONSENT, THE DIFFERENCE BETWEEN SAYING YES AND NO. YOU CAN SAY NOW WITHOUT A SIGNATURE, YOU REACH SOMEONE, THEY ARE AVAILABLE, THEY SAY NO, NO PARTICIPATION RESEARCH. BUT THEY ARE ON A CELL PHONE ON SOME OTHER CONTINENT, AND THEY CAN'T SIGN THE FORM. BUT THEY SAID YES. IS THAT REALLY -- THE OTHER PARENT SAID YES AND SIGNED THE FORM, THAT DOESN'T MAKE CENTS MAKE SENSE BUT YOU CAN'T GET A WAIVER, IF YOU HAVE TWO PARENTS IT'S LIKELY TO BE GREATER THAN MINIMAL RISK. YOU'RE IN A BIND. THAT'S WHAT THIS IS TRYING TO ANSWER. AND IT'S A PURELY -- THIS IS NOT AN ETHICAL ISSUE. THIS IS AN ISSUE OF NAVIGATING THE REGULATIONS TO GET THE OUTCOME THAT YOU FEEL IS BEST FOR THE CHILD AND THE FAMILY. AND WE'VE TALKED ABOUT THIS. I DON'T KNOW HOW TO MAKE IT SIMPLER. IT NEEDS TO BE CLEAR, I THINK WE'VE TRIED TO DO THIS, IF THEY SAY NO, THEY SAY NO. YOU NEVER HAVE TO SIGN A NO EXCEPT IN BROAD CONSENT. THAT'S A DIFFERENT ISSUE. >> YEAH. I WOULDN'T TRY TO INSERT THAT HERE. THIS IS REALLY ABOUT THE DOCUMENTATION. WHETHER IT NEEDS TO BE MORE CLEAR, ALL WE'RE SAYING IS EVERYBODY'S WILLING TO LET THE CHILD PARTICIPATE BUT ONE PARENT CANNOT GIVE YOU A VALID SIGNATURE FOR WHATEVER REASON, DISTANCE, WHATEVER IT IS, THEY SHOULD STILL BE ALLOWED TO ENROLL THE CHILD BECAUSE IT IS A MATTER OF WORKING THROUGH THE REGULATIONS BUT AN ETHICAL ISSUE, TWO PARENTS SAY THIS IS IMPORTANT FOR MY CHILD TO BE IN THIS RESEARCH BUT YOU WON'T LET ME BECAUSE PARENT A IS IN AFGHANISTAN AND CAN'T SIGN A FORM. SO IS THIS PARAGRAPH CLEAR ABOUT WHAT WE'RE TRYING TO SAY OR DOES IT NEED SOME HELP? >> IT'S FAIR. MICHELE, I WOULD BE HAPPY TO WORK ON THIS IF THIS IS THE DOCUMENT THAT WOULD LEND ITSELF TO A FLOWCHART TO DEMONSTRATE IN ANOTHER WAY THE PRINCIPLES WE'RE TRYING TO DESCRIBE BECAUSE THAT WILL HELP PEOPLE SEE THAT THERE'S A TWO-PART ANALYSIS, CAN YOU FIND THE PERSON, WHAT WE WERE TALKING ABOUT, THE LOCATION ISSUE, AND CAN THEY SIGN, AND THERE COULD BE A COUPLE DIFFERENT BRANCHES, RIGHT? YOU CAN FIND THEM AND THEY CAN SIGN, YOU CAN FIND THEM AND FOR WHATEVER REASON THEY CAN'T SIGN, BUT YOU STILL WANT TO FIGURE OUT WHETHER THEY HAVE SAID YES OR NO AND RESPECT THAT DECISION. >> I MEAN, THAT SOUNDED LIKE TWO BRANCHES. I GUESS I'M NOT SURE -- WELL, WE COULD CERTAINLY PUT A FLOWCHART IN. >> I DON'T KNOW THAT WE NEED IT. THIS IS A PRETTY LIMITED CIRCUMSTANCE. IF THE LANGUAGE ISN'T CLEAR I'D PREFER TO MAKE IT VERY CLEAR THAT -- >> SOMEBODY SAYS YES, THAT'S THE ONLY TIME YOU'RE IN THIS PARAGRAPH. IT'S ONLY THEY SAID YES, BUT THERE'S NO WAY FOR THEM TO SIGN. >> THAT'S WHY I THOUGHT THE FLOWCHART. >> BUT IT SAYS THAT. >> YOU'RE NEVER AT THE NO. ANYBODY SAYING NO, THIS DIDN'T APPLY. I DON'T KNOW HOW YOU DO A FLOWCHART UNLESS -- YOU KNOW. >> SO WHAT ABOUT -- WOULD IT BE EXTRA CLEAR IF THE ITALICIZED WITH THE PORTION, LAST WORD AT 156, DECISION SPECIFICALLY SAY TO ENROLL OR PERMIT OR SOMETHING LIKE THAT, RESPECTING PARENTS' DECISION, YOU KNOW, MAY MAKE IT SOUND LIKE WE'RE TALKING ABOUT YES OR NO BUT WE'RE ONLY TALKING ABOUT YES. >> [ INAUDIBLE, OFF MIC ]. >> NO, IT'S NOT. IT'S ABOUT YES. >> [ INAUDIBLE, OFF MIC ]. IT'S EITHER WAY. YOU DON'T WANT TO LEAVE OPEN IF THEY SAY -- (INAUDIBLE) -- REGARDLESS OF WHETHER THEY SIGN OR NOT. >> THERE'S A LAND IN THE BACK. WE CAN LET JONATHAN MAKE A COMMENT. YOU HAVE TO GO TO THE MIC, JONATHAN. WAIT TILL YOU'RE AT THE MIC BECAUSE I CAN'T HEAR YOU. >> MAY INCLUDE CIRCUMSTANCES A PARENT IS AVAILABLE TO PARTICIPATE IN CONSENT PROCESS AND HAS GIVEN PERMISSION FOR THE CHILD'S PARTICIPATION, THAT MAKES IT ABUNDANTLY CLEAR IT ONLY APPLIES IN A QUESTION SITUATION. >> BUT THAT MAKES THE SENTENCE WITH THE ITALICIZED PORTION THAT SAYS UNDER THESE CIRCUMSTANCES SENTENCE IS ABOUT EITHER WAY, SO WE WANT TO DELETE UNDER THESE CIRCUMSTANCES. >> I AGREE. I WAS THINKING THE SAME THING. >> SHOULD WE ALSO SAY HOWEVER SACHRP PROPOSES OR RECOMMENDS -- (INAUDIBLE) -- WE'RE STRETCHING THE REGULATORY LANGUAGE. I DON'T THINK THIS IS A -- THIS IS (INAUDIBLE). >> I THINK THIS IS ANOTHER INSTANCE WHERE WE SHOULD RECOMMEND THAT OHRP RECONSIDER THE REGULATION BECAUSE THE REGULATION IS THAT YOU CAN'T ALLOW A WAIVER OF DOCUMENTED CONSENT FOR MORE THAN MINIMAL RISK. THE REGULATION IS QUITE CLEAR. >> WE STARTED THERE IN CONVERSATIONS, BUT I DON'T REMEMBER IF IT WAS SUBCOMMITTEES OR WALKING ON THE STREET BUT BASICALLY INTERPRET THE WAIVER TO USE ENFORCEMENT DISCRETION IN THAT SETTING OR REVISIT THE WAIVER CRITERIA, FELT TO BE MUCH HIGHER BAR FOR THIS AND LONGER TERM BUT I THINK WE ALL AGREE. >> MIGHT AN ALTERNATIVE BE SAYING WHAT ABOUT GUIDANCE ON WHAT COUNTS AS DOCUMENTATION UNDER CIRCUMSTANCES WHERE NOW THERE'S A LOT OF DIFFERENT WAYS TO CONTACT THE SECOND PERSON. >> LIKE A RECORDING OF THE SKYPE CONVERSATION. >> ON THE OHRP IT'S DIFFICULT, THE FDA SIDE, WE MADE IT CLEAR THAT THEY ARE IN TERMS OF ELECTRONIC SIGNATURES, WHATEVER IT IS, YOU COULD TYPE YOUR NAME, YOU DON'T HAVE TO MEET -- I KNOW FDA HAS COMPLICATED RULES FOR GOOD REASONS. SO WE WERE TALKING ABOUT SOMEBODY'S ON A PHONE, HOW OFTEN IS IT GOING TO BE THESE DAYS THEY ARE ON A PHONE THAT PROBABLY IS A CELL PHONE, THEY COULD WRITE THEIR NAME ON A PIECE OF PAPER, TAKE A PICTURE AND E-MAIL. I SUSPECT EXACTLY THIS POINT THAT ON OUR END WE'VE TRIED TO BE VERY FLEXIBLE, CONSISTENT WITH THE PURPOSE OF THE RULE. SO AS LONG AS THERE'S SOME WAY OF DOCUMENTING IT AND COULD BE PRETTY GENEROUS, I SUSPECT THAT'S SOMETHING WE PROBABLY WOULD BE RECEPTIVE TO, THIS IS NOT ALL THAT BIG A PROBLEM THESE DAYS, IF YOU'RE ABLE TO CONTACT SOMETHING IT'S BECAUSE YOU DO HAVE THEM -- EVEN IF THEY ARE IN THE AMAZON RAINFOREST, THEY ARE ON A CELL PHONE BE ON ELECTRONIC DEVICE WITH WAYS OF DOING THIS, ON OUR END WE'VE TRIED TO BE GENEROUS, ONE WAY OR ANOTHER YOU COULD SAY THIS IS DOCUMENTATION. >> INSERTING LANGUAGE THAT MAKES THAT CLEAR PROBABLY WOULD BE HELPFUL BECAUSE I SUSPECT EVEN THOUGH THE FREQUENCY WITH WHICH THIS HAPPENS I THINK IS PROBABLY NOT THAT GREAT, IT PROBABLY IS BECAUSE THERE'S AN IRB THAT SAYS THE ONLY DOCUMENTATION WE'RE GOING TO ALLOW YOU TO ACCEPT IS A HANDWRITTEN ON THE CONSENT FORM OR PARENTAL PERMISSION FORM, WE DON'T WANT TO HEAR ABOUT TAKING PICTURES OF SIGNATURES, GETTING AN E-MAIL BACK. >> (INAUDIBLE). >> OR HAVING SOMEBODY TYPE ON SKYPE, WHICH IS NOT A SIGNATURE BUT IT COULD BE APPROPRIATE DOCUMENTATION. >> WHAT IS ACCEPTABLE? THEY DON'T HAVE THE FORM, THEY TYPE YES, YES I WANT MY CHILD TO PARTICIPATE IN THIS RESEARCH, THEY SEND YOU THAT TEXT. IS THAT CONSIDERED DOCUMENTATION? I DON'T KNOW WHAT THE ANSWER IS. WE'RE TRYING TO FIND A WAY, THAT WOULD BE GREAT. BUT I DON'T KNOW. AND IF YOU EXTEND THAT TO THE PARENT, WHAT IF THE OTHER PARENT SAYS I DON'T WANT TO COME IN AND SIGN MY FORM, YOU LET MY HUSBAND DO IT.. >> OHRP IS WILLING TO BE FLEXIBLE BUT WHAT DOES THAT MEAN? YOU CAN SAY ANYTHING YOU CAN TRACE BACK TO THAT PERSON, EVEN IF IT'S ACTUALLY NOT A SIGNATURE, BUT INDICATES A WILLINGNESS TO BE DOCUMENTATION. >> I'M NOTING THERE'S A REALITY OF WHAT OHRP HAS DONE, IN TERMS OF ELECTRONIC SIGNATURES LOTS OF TIMES YOU NEED DOCUMENTATION IN TERMS OF ONLINE INTERNET STUFF OR SOMETHING, WE'RE NOT REQUIRING CREDIT CARDS OR ANYTHING LIKE THAT. WE'VE ALREADY GOT IN PRINT SOME WHETHER SAYING THE PERSON IS SAYING THEY ARE THIS PERSON, THEY ARE ANSWERING THE SURVEY, YOU'RE NOT GETTING A SIGNATURE FROM THEM BUT THEY ARE TYPING THEIR NAME ON THE LINE OR SOMETHING. I'M PRETTY SURE ONE WAY OR ANOTHER WE'VE SAID THAT'S FINE IN A LOT MORE STUDIES THAN THESE RARE CIRCUMSTANCES. ALL I'M SAYING THERE'S ALREADY STUFF OUT THERE INDICATING AGAIN CERTAINLY FOR BENIGN CIRCUMSTANCES, OBVIOUSLY DIFFERENT TALKING ABOUT THE PERSON'S CONSENT TO TEN MINUTES FROM THEN GO INTO MAJOR HEART SURGERY, AND YOU'RE NOT CHECKING OTHER THAN TYPE THEIR NAME ON A LINE, THAT'S DIFFERENT. I'M SAYING THE REALITY IS THERE ARE A VARIETY OF CIRCUMSTANCES OHRP HAS ALREADY SAID THERE ARE A LOT OF OTHER WAYS FOR GETTING DOCUMENTATION THAT SOMEBODY SIGNED SOMETHING OTHER THAN NEEDING A SIGNATURE BECAUSE WE'RE DOING THIS ON THE INTERNET. SO PROBABLY THOUSANDS OF TIMES A DAY. >> I DON'T WANT TO TAKE THE DOCUMENT BACK BUT ALMOST SOUND LIKE THIS PARAGRAPH COULD DISAPPEAR, IF INDEED -- MAYBE ALL THAT'S NEEDED IS JUST SOMETHING THAT TALKS ABOUT HOW, YOU KNOW, THERE MAY BE OTHER WAYS OF DOCUMENTING THAT SOMEBODY IS WHO THEY ARE AND WHAT THEIR INTENT IS. IF YOU HAVE THE PERSON IN AFGHANISTAN WHO IS OUT IN THE FIELD, YOU'RE CONTACTING THEM, COMMUNICATING BY SKYPE OR SOMETHING, WHO KNOWS HOW, COULD YOU TAKE A PICTURE OF THAT? THERE'S LOTS OF WAYS TO -- I'M JUST WONDERING LIKE IF THERE IS SOME FLEXIBILITY ALREADY THEN WHAT IS THIS SAYING? >> THE PROBLEM I SEE WITH THAT, I DON'T KNOW THAT -- THIS IS A VERY SPECIFIC CIRCUMSTANCE WHERE THE SECOND PARENT -- GREATER THAN MINIMAL RISK RESEARCH, THIS IS YOU DON'T WANT TO SAY IN 50.53 SUBPART D STUDY TO ACCEPT CONSENT ON THE INTERNET, THERE'S ANOTHER ARM, HAS TO BE THE SAME CONSENT PROCESS FOR BOTH ARMS. SO DO YOU WANT -- WHY FOR ONE PARENT THAN ANOTHER, I THINK IT'S MORE COMPLICATED. >> THERE'S TWO ELEMENTS, ONE IS THE INFORMED PART, THE OTHER IS THE CONSENT PART. IF YOU'RE TALKING ABOUT INTERNET SURVEY, THEY COMPLETE IT, THEY UNDERSTAND WHAT THEY WERE BEING ASKED TO DO BECAUSE IT WAS PART OF THE SURVEY AND THEY DID IT. IN THIS CASE YOU DON'T KNOW THEY WERE FULLY INFORMED, IF ALL YOU HAVE IS A SIGNATURE. YOU DON'T HAVE ANY DOCUMENTATION THAT THEY WERE INFORMED, ALL YOU HAVE A SIGNATURE. IT'S DIFFERENT THAN A SURVEY WHERE YOU CLICK I'M WILLING TO DO THE SURVEY, CAN SKIP A QUESTION, DO ANYTHING YOU WANT BUT ARE GIVING CONSENT AS YOU GO ALONG BECAUSE YOU'RE BEING ASKED TO DO CERTAIN THINGS. >> DAVID, WHAT ABOUT ALTERNATIVE PUTTING ANOTHER SENTENCE OR PARAGRAPH AFTER THIS THAT SAYS AS AN ALTERNATIVE IT MAY BE ACCEPTABLE TO USE NON-TRADITIONAL FORMS OF DOCUMENTATION IN THE CIRCUMSTANCES FOR THE SECOND PARENT OR SOMETHING, NANCY? >> I WOULDN'T PUT IT AS A SEPARATE PARAGRAPH. I WOULD PUT A SENTENCE OR TWO AFTER THE ITALICIZED PORTION, SAY SACHRP RECOMMENDS THAT IRBs EXPLORE WHAT COUNTS, EXPLORE WHAT SHOULD COUNT AS ACCEPTABLE FORM OF PERMISSION IN WRITING WHICH MIGHT BE -- WHICH MIGHT BE BROADER UNDER THESE CIRCUMSTANCES THAN WOULD OTHERWISE BE ACCEPTABLE, AND THEN YOU CAN SAY, IF THE IRB DOESN'T -- THEN YOU HAVE -- BUT THEN THE DEFAULT IS SAYING THAT THE SECOND PARENT IS NOT AVAILABLE. FIRST YOU GO THROUGH ALTERNATIVE -- >> JUST PUTTING IT THERE. >> BUT THE IRB IS NOT -- IT'S THE INVESTIGATORS FACED WITH THESE SITUATIONS. >> THE IRB CAN SAY WHAT COUNTS AS ACCEPTABLE AND THEN BE READY FOR A RANGE AND THEN THE INVESTIGATORS ARE GOING TO DO IT BUT NECESSARILY WANT TO MAKE STUFF UP UNLESS THE IRB HAS SORT OF THOUGHT WHAT MIGHT BE ACCEPTABLE. >> I DON'T THINK IT'S IN THE PURVIEW OF THE INVESTIGATOR TO DECIDE WHAT'S AN ACCEPTABLE SIGNATURE. I'M NOT SURE THAT'S A GREAT PRECEDENT. THAT SHOULD BE SOMETHING THAT'S APPROVED BY THE IRB BUT WHETHER SOMEONE IS REASONABLY AVAILABLE HAS TO BE UP TO THE INVESTIGATORS BECAUSE THEY ARE THERE, THE IRB IS NOT. THE OBLIGATION FALLS ON TWO DIFFERENT PARTIES. >> ANOTHER WAY TO APPROACH TO AVOID HAVING THE WHOLE DOCUMENT GO BACK FOR MORE WORK IS SACHRP RECOMMENDS THAT GUIDANCE BE ISSUED INDICATING WHAT WOULD BE ACCEPTABLE FORMS OF DOCUMENTATION IN CIRCUMSTANCES LIKE THIS. THAT'S A ONE QUESTION FAQ, NOT A WHOLE DOCUMENT. >> IF YOU COULD CHANGE IRB -- (INAUDIBLE). >> I DON'T KNOW HOW PEOPLE FEEL ABOUT THAT BUT THAT WOULD BE A VALID RECOMMENDATION GIVEN THIS CONVERSATION AND NOT REQUIRE A DOCUMENT WHERE WE'RE FINE WITH THE BULK, GO BACK ON ONE POINT. >> SUCH A VERY SPECIFIC CIRCUMSTANCE. >> YEAH. WE COULD ALSO RECOMMEND GET RID OF COMPONENT ANALYSIS AND LEAVE THAT HANGING OUT THERE. THAT'S WHAT'S TRIPPING UP HALF OF THESE. . I'LL ADD A RECOMMENDATION ABOUT GUIDANCE ON ONE SPECIFIC POINT AND SEE IF THAT RESOLVES IT. >> SO BRING IT BACK TOMORROW MORNING. (INAUDIBLE). ANY OTHER COMMENTS ON THIS? WE'LL BRING IT BACK TOMORROW MORNING. WE'VE HAD A LOT OF DISCUSSION ABOUT THIS AND THE PRECEDING DOCUMENT. THE GOAL IS TO GIVE DAVID ALL OF OUR THOUGHTS ON THIS NOW. SO WHAT COMES BACK TO US TOMORROW FOR REVIEW, CHANGES, TO SIGN OFF. I'M GOING TO MAKE A LAST CALL WHETHER THIS DOCUMENT RAISES OTHER CONCERNS FOR PEOPLE. ALL RIGHT. I THINK IT'S PROBABLY CLOSE TO TIME FOR PUBLIC COMMENT. >> I DON'T THINK THERE IS ANYONE SIGNED UP BUT ANY PUBLIC COMMENT? >> ALL RIGHT. THANK YOU ALL. JULIA THOUGHT WE WERE GOING TO GET OUT WAY EARLY. BUT WE'RE ADJOURNED FOR THE DAY. THANK YOU.