>> I WILL CALL THIS MEETING OF SACHRP TO ORDER AND WE'LL START WITH A ROLL CALL. I'M GOING TO READ OUT THE MEMBERS. IT IS ALWAYS DISORGANIZED TO TRY TO DO THAT. MARY ALLEN ENGLE, ARE YOU ON? I KNOW SHE WAS ON. SHE MAY BE MUTED. WE'LL COME BACK TO HER [ INAUDIBLE ] [ BACKGROUND NOISE ] >> NICOLE? >> I'M HERE. >> DYING LAS? >> I'M HERE. >> THANK YOU. DOUGLAS -- [ INAUDIBLE ] [ ROLL CALL ] ANYONE ELSE ON THE CALL THIS MORNING? >> YOU'LL NEED TO UNMUTE YOURSELF. >> THIS IS JULIE. >> THANK YOU. >> PRICHARD IS ON. >> COLLMAN. >> ALL RIGHT. DO WE HAVE MARY ALLEN ENGLE? >> YOU HAVE MARY ALLEN ALLEN. >> I'M SORRY. MY APOLOGIES, YES. SO THANK YOU. I'M HEARING AN ECHO. IF EVERYBODY COULD MUTE WHEN YOU'RE NOT TALKING. I'M GOING TO GO THROUGH THE OTHER AGENCIES TO ASK FOR EX OFFICIOS SINCE I DON'T HAVE A LIST OF YOUR NAMES. IS ANYONE ON THE CALL FROM FDA? >> THIS IS JOANNE. >> GOOD MORNING, THIS IS KEVIN. >> AND FROM CDC? HOW ABOUT AHRQ? OKAY, FROM HRSA? FROM NIH? [ INAUDIBLE ] >> THIS IS -- FROM NIH. >> THANK YOU. >> FROM OCR? >> THIS IS PAYTON FROM OCR. >> AND FROM IHS? ARE THERE ANY OTHER EX OFFICIOS OR AGENCY STAFF OHRP STAFF THAT I HAVE NOT CALLED ON? THANK YOU. SO FIRST OF ALL, WELCOME. FOR THOSE WHO HAVEN'T BEEN ON THE CALL FOR AN HOUR, WE ARE JUST GOING THROUGH ONE TECHNICAL THING AFTER ANOTHER. THIS IS STILL A LEARNING EXPERIENCE FOR ALL OF US. SO, PLEASE BE PATIENT AND UNDERSTANDING IF THINGS DON'T ALWAYS WORK AS SMOOTHLY AS THEY SHOULD. I REALLY DIDN'T APPRECIATE THE VALUE OF IN-PERSON MEETINGS UNTIL THE LAST SEVERAL MONTHS. AND I'M SURE THAT I'M NOT ALONE. I WANT TO NOTE THAT I'M WARING A MASK BECAUSE WALTER STRAWS AND I ARE IN THE SAME ROOM. WE ARE JUST FOLLOWING PUBLIC GUIDELINES, AND I THOUGHT THAT NEEDED SOME EXPLANATION. I HAVE THE PRIVILEGE. LIVING IN MANE, WHICH IS A VACATION DESTINATION, SO IF ANY OF THE REST OF YOU ARE HERE FOR THE NEXT ONE, YOU'RE WELCOME TO JOIN US HERE TOO. I'M GOING TO GO THROUGH A NUMBER OF PROCEDURAL ISSUES. SO COMMITTEE MEMBERS AND THE PUBLIC ARE USING DIFFERENT PLATFORMS FOR PARTICIPATING TODAY. COMMITTEE MEMBERS ARE USING WEBEX AND THE PUBLIC IS COMING IN ON THE NIH VIDEOCAST. FOR COMMITTEE MEMBERS, IF YOU HAVE A QUESTION OR COMMENTERS ON THE ITEM UNDER DISCUSSION, PLEASE USE THE RAISE HAND FUNCTION ON THE PARTICIPANT LIST. SO IF YOU HOVER OVER YOUR NAME, YOU SHOULD HAVE THE ABILITY TO RAISE YOUR HAND. IT'S TOWARDS THE RIGHT, RIGHT BEFORE THE LITTLE VIDEO CAMERA OR WHATEVER ICON IS APPROPRIATE FOR YOU. PRESENTERS, YOU CAN ONLY SEE RAISED HANDS IF YOU'RE A PRESENTER. SO FOR PRESENTERS, PLEASE KEEP AN EYE ON THOSE. THERE IS ALSO AN ABILITY TO SEARCH -- TO SORT, I'M SORRY BY RAISED HAND. SO IF SOMEONE RAISES THEIR HAND, THEY COME TO THE TOP OF THE LIST, WHICH IS IMPORTANT BECAUSE WE DON'T HAVE THAT MUCH SPACE FOR THE WHOLE LIST. AND THEN OBVIOUSLY, IT'S GOING TO BE THE PRESENTERS MONITORING AND THEY ALSO WILL BE PRESENTING. SO IF YOU'RE NOT TAKEN IN TURN OR YOU FEEL LIKE NO ONE IS NOTICING YOUR RAISED HAND, BE PATIENT BUT ALSO USE THE CHAT BOX BECAUSE I THINK IT'S QUITE POSSIBLE DURING THE COURSE OF THESE TWO DAYS, SOMEONE WILL FORGET TO CHECK THE RAISED HANDS. PLEASE BE UNDERSTANDING. ONCE YOU RAISE YOUR HAND -- PLEASE LOWER IT BY CLICKING ON THE SAME ICON. FOR PEOPLE ON THE VIDEOCAST, FROM IS A LINK TO SEND AN E-MAIL WITH QUESTIONS AND COMMENTS. WE ARE NOT GOING TO BE ABLE TO RESPOND TO THOSE IN REALTIME BUT WE WILL REVIEW THEM. THE PLAN IS TO REVIEW THEM DURING THE BREAKS AND TO RESPOND TO THEM IN THE PUBLIC COMMENT PERIOD. DEPENDING ON HOW MANY WE GET, WE MAY OR MAY NOT GET TO YOU ALL. PLEASE UNDERSTAND THE LIMITATIONS OF THE PLATFORM, AND I APOLOGIZE FOR THAT. THE OTHER THING THAT IS VERY IMPORTANT IS THAT WE ARE USING A NEW MECHANISM TO SHARE MEETING MATERIALS, SO THEY ARE NOW POSTED AT www.regulations.gov. AND THOSE ARE -- I'M NOT GOING TO SPELL THAT OUT BUT I WILL SPELL OUT THE DOCKET. SO ONCE YOU GO ON REGULATIONS.GOV, YOU HAVE TO SEARCH FOR A SPECIFIC DOCKET AND THEN OPEN IT UP AND NAVIGATE THROUGH THE FILES. THE DOCKET NUMBER IS HHS- IT'S ALL CAPS. OPHS-2020-0004. SO HOPEFULLY PEOPLE GOT THAT. I DON'T KNOW IF THAT IS POSTED ANYWHERE ON THE VIDEOCAST LINK. >> I'M SORRY, STEPHEN, THIS IS JULIA, I'LL JUST INTERRUPT FOR A MOMENT. THAT DOCKET IS POSTED ON THE SACHRP PAGE AS WELL AS OTHER INFORMATION SURROUNDING THE MEETING. DOCKET NUMBER IS POSTED ON THE SACHRP MEETING PAGE. >> THANK YOU. ALL RIGHT. SO FOR THOSE WHO ARE PARTICULARLY ATTENTIVE DURING THE ROLL CALL, YOU MAY HAVE NOTICED OUR ROSTER HAS CHANGED. WE SAID GOOD BY TO TWO MEMBERS, NANCY KING AND SANDRA BARRY, BOTH OF WHICH HAVE BEEN MEMBERS OF THE COMMITTEE. NANCY JOINED IN 2015 AND SANDY IN 2016. THEY PARTICIPATED ON OUR DELIBERATIONS FROM OUR ORIGINAL DISCUSSIONS OF THE NPRM THROUGH OUR SACHRP RECOMMENDATIONS REGARDING THE NEW COMMON RULE AND I THINK IT'S REALLY BEEN A UNIQUE PERIOD BECAUSE OF THE SCOPE OF TOPICS WE HAVE BEEN ASKED TO ADDRESS DURING THAT TIME AND I WANTED TO THANK BOTH OF THEM. NANCY CONTINUES ON THE SUBCOMMITTEE. WE ALSO HAVE TWO NEW MEMBERS, AND I WILL GO OVER THEIR BIOS, BUT THEN I'LL ASK THEM IF THEY EACH WANT TO SAY A FEW WORDS ABOUT THEMSELVES. SO FIRST KEVIN WINE FURT, A PH.D., PROFESSOR AND VICE-CHAIR OF RESEARCH IN THE POPULATION HEALTH SCIENCES AT DUKE UNIVERSITY MEDICAL CENTER. THE FACULTY MEMBER OF THE DUKE MEDICAL RESEARCH INSTITUTE. HE IS ALSO A PROFESSOR OF PSYCHOLOGY AND NEUROSCIENCE, PROFESSOR OF PSYCHIATRY AND BEHAVIORAL SCIENCES AND A FACULTY ASSOCIATE OF THE CENTER FOR THE STUDY OF MEDICAL HUMANITIES. HE CODIRECTS THE CENTER FOR HEALTH MEASUREMENT AT DUKE. HE RECEIVED HIS PH.D. IN PSYCHOLOGY FROM GEORGETOWN AND GRADUATE WORK IN HISTORY OF SCIENCE AND PHILOSOPHY AT OXFORD. HE CURRENTLY CONDUCTS RESEARCH ON MEASURING PATIENT REPORTED OUTCOMES, THE PSYCHOLOGY OF MEDICAL DECISION-MAKING AND BIOETHICS. AND HIS BIOETHICS RESEARCH IS FOCUSED ON CONFLICTS OF INTEREST AND CLINICAL RESEARCH. THE USE OF CENTRAL IRB REVIEWS AND ETHICAL TREATMENT OF PARTICIPANTS IN PRAGMATIC TRIALS. CURRENTLY, HE IS THE CO-PI OF THE COORDINATING CENTER FOR THE NIH HEALTH SYSTEMS RESEARCH COLLABORATORY, WHICH IS DEDICATED TO IMPROVING UNDERSTANDING OF HOW TO CONDUCT PRAGMATIC TRIALS. IS THERE ANYTHING I MISSED YOU'D LIKE TO ADD OR ANY REMARKS YOU'D LIKE TO MAKE? >> NO, THANKS. JUST TO SAY GOOD MORNING AND I'M VERY HAPPY TO BE ON AND I THANK EVERYONE IN ADVANCE FOR THEIR PATIENCE AS I LEARN THE ROPES HERE. >> THANK YOU. AND I APOLOGIZE TO BOTH YOU AND DOUG FOR INTRODUCING YOU. OR HAVING YOUR INTRODUCTIONS TO SACHRP BEING IN THIS AWKWARD SETTING. HOPEFULLY WE'LL RETURN TO NORMAL SEE SOMETIME SOON. OUR SECOND NEW MEMBER IS DR. DOUG DEAC MA, MDMPH, ATTENDING PHYSICIAN AND DIRECTOR OF EDUCATION FOR THE TRUMAN CATS CENTER FOR PEDIATRIC BIOETHICS AT SEATTLE CHILDRENS AND A PROFESSOR IN THE DEPARTMENT OF PEDIATRICS AT THE UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE. HE RECEIVED HIS MD FROM THE UNIVERSITY OF NORTH CAROLINA AND MPH FROM THE UNIVERSITY OF WASHINGTON. AND COMPLETED RESIDENCY AT THE UNIVERSITY OF WISCONSIN-MADISON. BOARD CERTIFIED IN GENERAL PEDIATRICS AND PEDIATRIC EMERGENCY MEDICINE AND HE'S PAST CHAIR OF THE COMMITTEE ON BIOETHICS OF THE AMERICAN ACADEMY OF PEDIATRICS AND SERVES ON THE ETHICS COMMITTEE OF THE AMERICAN BOARD OF PEDIATRICS. HIS RESEARCH INTERESTS INCLUDE PEDIATRIC BIOETHICS AND PEDIATRIC WILDERNESS MEDICINE. DR. DEAC MA, ANYTHING TO ADD? WELCOME. >> NOTHING TO ADD. I'M DELIGHTED TO JOIN THIS GROUP. THANKS. >> WE ARE GLAD TO HAVE YOU. JERRY ANY REMARKS? >> THANK YOU, STEPHEN. I DO HAVE SOME COMMENTS. WELCOME EVERYBODY. WE ARE PARTICULARLY LOOKING FORWARD TO A VERY PRODUCTIVE TWO DAYS AND ARE PLEASED THAT SACHRP IS TACKLING SUCH A WAVY SET OF TOPICS, INCLUDING IN PARTICULAR, RESEARCH INVOLVING INTERVENTIONS AND DONATED ORGANS, INTERPRETING THE PUBLIC HEALTH SURVEILLANCE AND THE DEFINITION OF RESEARCH. WHO KNEW DURING THE SEVERAL YEARS WHILE THE COMMON RULE IS BEING REVISED THAT DOING PUBLIC HEALTH SURVEILLANCE WOULD BECOME SUCH A IMPORTANT HOT TOPIC GENERATING DAILY HEADLINES ACROSS THE WORLD? IT ENDED UP BEING A CHANGE TO THE RULES AND UNDERSTANDING ITS FULL SCOPE IS NOW QUITE IMPORTANT AND JUSTICE, ANOTHER TOPIC THAT IS SO VERY APPROPRIATE FOR THE TIMES WE ARE LIVING IN. SO, VERY BIG THANK YOU TO YOU, STEPHEN, TO THE SUBCOMMITTEE CHAIRS, TO THE SACHRP MEMBERS, TO EX OFFICIOS, TO JULIA AND CECILIA AND THE OTHERS AT OHRP. SO ALL OF YOU, FOR THE WORK YOU HAVE BEEN DOING BEHIND-THE-SCENES UP UNTIL NOW AND THE WORK YOU OF COURSE, WILL BE DOING DURING THIS MEETING AND FOR A LONG TIME AFTERWARDS. I'M PLEASED TO WELCOME OUR TWO NEW MEMBERS, DR. WINE FURT AND DR. DEAC MA. WE ARE THRILLED THAT THEY ARE JOINING SACHRP AND I MUST SAY I HAVE BEEN PRIVILEGED TO BE ABLE TO WORK WITH THEM IN THE PAST AND LOOK FORWARD TO WORKING WITH THEM AGAIN AS THEY SERVE ON SACHRP. IN TERMS OF UPCOMING EVENTS FROM OHRP, I WANT TO MENTION AN EVENT AT OUR EDUCATION DIVISION WILL BE HAVING. THIS IS A ONE-DAY ON LINE WORKSHOP ON SEPTEMBER 17. WE HAD ONCE A YEAR THESE ONE-DAY WORKSHOPS IN PREVIOUS YEARS. THE TOPIC THIS TIME AROUND WILL BE PRACTICAL AND ETHICAL CONSIDERATIONS FOR SINGLE IRB REVIEW. A FREE, LIVE WEBINAR. YOU CAN FIND OUT MORE INFORMATION ABOUT IT, INCLUDING THE AGENDA ON THE EDUCATION DIVISION SECTION OF OHRP'S WEBSITE. AND FINALLY, LAST BUT DEFINITELY NOT LEAST, I WANT TO LET EVERYBODY KNOW ABOUT A UNIQUE OPPORTUNITY. OHRP IS LOOKING FOR A NEW DIRECTOR OF ITS POLICY AND ASSURANCES DIVISION. THIS IS ONE OF THE MOST SENIOR POSITIONS AT OHRP AND AS YOU CAN IMAGINE, RUNNING THE POLICY UNIT AT OHRP CRADLE THE POTENTIAL FOR HAVING HUGE IMPACT ACROSS THIS COUNTRY IF NOT THE WORLD. PARTICULARLY IN THE TIMES WE ARE LIVING IN RIGHT NOW. GIVEN WHAT IS GOING ON IN THE WORLD, MANY PEOPLE ARE REMINDED THAT LIFE IS SHORT AND MAYBE THEY HAVE BEEN RETHINKING ABOUT WHAT REALLY MATTERS AND WHAT YOU WANT TO ACCOMPLISH IN YOUR LIFE. AND SORT OF WONDERING ABOUT THE IMPORTANCE OF WHAT THEY ARE DOING DAY-TO-DAY. SO IT COULD BE MAYBE RUNNING OHRP'S POLICY UNIT IS EXACTLY WHAT YOU HAVE BEEN LOOKING FOR AND WHAT YOU NEED. YOU COULD BE THE VERY TALENTED PERSON WE NEED. SO LIFE IS SHORT. TIME IS SHORT. I AM SHORT. SO MAYBE YOU WANT TO DIG OUT THAT OLD RANDY NEWMAN ALBUM AND PUT IT ON THE TURNTABLE AND LOOK UP THE OHRP JOB ANNOUNCEMENT. GO TO USAJOB DOGOV 571348800. USAJOB.GOV. THERE IS A CAP ON THE NUMBER OF APPLICATIONS SO IT MIGHT CLOSE BEFORE FRIDAY. IF YOU'RE INTERESTED, AND YOU THINK YOU'RE THE RIGHT PERSON FOR THIS VERY ENUKE AND CHALLENGING POSITION IN THESE CHALLENGING TIMES, DON'T HESITATE TO APPLY. AND NOW, BACK TO YOU, STEPHEN. >> DR. ROSENFELD: THANK YOU, JERRY. THAT WAS A HEARTFELT PITCH. ALL RIGHT. SO WE ARE GOING TO MOVE ALONG WITH THE AGENDA AND THE NEXT ITEM IS SACHRP COMMENTS AND RECOMMENDATIONS ON THE NIH DRAFT DATA MANAGEMENT AND SHARING POLICY. LET ME SEE IF I CAN BRING THE DOCUMENT UP. THERE WE GO. AND I WOULD ALSO LIKE TO REMIND PEOPLE TO MUTE WHEN YOU'RE NOT SPEAKING. AND I'LL TURN IT OVER TO MARK BARNS. >> DR. BARNES: THANK YOU, STEPHEN. CAN YOU HEAR ME? GREAT. EXCELLENT. SO, GOOD MORNING, EVERYONE. WHAT I WANT TO PRESENT TO YOU IS A SET OF DRAFT COMMENTS THAT THE SUBCOMMITTEES HAVE WORKED ON FOR SOME MONTHS AND HAVE DISCUSSED IN OUR VARIOUS SESSIONS REALLY FOR THE PAST MONTHS TOGETHER, PROBABLY SINCE MARCH OR APRIL WHEN WE WERE FIRST ASKED TO COMMENT WHEN SACHRP WAS ASKED TO COMMENT ON THE NIH DRAFT DATA SHARING POLICY. SO WHAT WE HAVE HAS BEEN WORD SMITH PROCESSED, REPROCESSED AND PROCESSED AGAIN. I'M GOING TO GO INTO THE DOCUMENT AND TRY TO GIVE YOU THE HIGHLIGHTS OF THE RECOMMENDATIONS WHICH ARE IN BOLD IN THIS DOCUMENT. I DO WANT TO SAY AS A PREFACE THAT ONE HAS TO REMEMBER THAT WE ARE AT THE INITIAL STAGES, AS IS THE NIH AS A RESEARCH COMMUNITY AND THE NIH AND DRAFT POLICY, ARE REALLY AT THE INITIAL STAGES OF TRYING TO UNDERSTAND WHAT DATA SHARING IS, HOW IT SHOULD WORK, HOW CREDIT SHOULD BE ALLOCATED, THE RIGHTS OF PEOPLE WHO ARE THE FUNDERS, INVESTIGATORS, INSTITUTIONS, HOSTING INVESTIGATORS, THOSE WHO MAKE THE DATASETS AVAILABLE AND IN THE HUMAN SUBJECTS CONTEXT THE RIGHTS AND PROTECTIONS FOR THE HUMAN SOURCES OF THE DATA. THEREFORE, WHAT THE NIH HAS PUT FORWARD AS A DRAFT, AND FOR WHICH IT SOUGHT COMMENTS EARLIER THIS YEAR IS DRAFTED AT A HIGH LEVEL OF GENERALITY. THEREFORE, OUR -- AND THAT IS UNDERSTANDABLE GIVEN THE MANY QUESTION THAT IS LURK IN THE REALM OF DATA SHARING AND ALL OF THE IMPLEMENTATIONS THAT WORK IN MANY DIFFERENT FACETS, ASPECTS AND DIMENSIONS. AND SO THEREFORE, OUR COMMENT ON THE NIH POLICY ARE ALSO NOT CONCLUSIVE. THEY ARE TRYING TO STATE BRINGS PELISSES AND VALUES AND POINTS OF VIEW. THEY ARE NOT TRYING TO GIVE THE FINAL DETERMINATION AS TO HOW ALL OF THIS ULTIMATELY SHOULD WORK. IF YOU THINK OF THE 53 STATIONS OF THE -- BETWEEN QUOTEO AND ETO, WHICH IS NOW CALLED TOKYO, WE ARE AT THE FIFTH STATION. WE ARE NOT AT THE 52nd STATION. SO IN YOUR COMMENTS AND AS YOU THINK ABOUT WHAT WE HAVE DRAFTED, THEN PLEASE REMEMBER THAT THIS IS A CONTINUING CONVERSATION. THIS IS ONLY THE PROPOSED OPINION OF SACHRP AT THIS POINT IN TIME REACTING TO AN NIH DOCUMENT THAT AS I SAID, IS DRAFTED AT A HIGH LEVEL OF GENERALITY. I SAY THAT BECAUSE WHAT I THINK WOULD NOT BE USEFUL -- SACHRP MEMBERS CAN USE THE TIME AS THEY WISH, FROM MY POINT OF VIEW IT WOULD NOT BE USEFUL TO THINK IN THIS DRAFT, WE ARE TRYING TO MAKE FINAL CONCLUSIONS ABOUT ANYTHING. WE ARE TRYING TO STATE POINTS OF VIEW, VALUES, PRINCIPLES, CONSIDERATIONS TO MOVE US FROM THE FIFTH STATION TO THE 6th STATION OR 7th, NOT TO GET TO THE END. SO STEPHEN, I'M GOING TO, IF IT'S OKAY WITH YOU, I'LL PROCEED AND TRY TO SUMMARIZE. I GUESS WHAT I'LL DO, WHAT I'D LIKE TO DO IS TO GO THROUGH THE DOCUMENT AND SUMMARIZE ALL OF IT AND THEN LET'S GO TO QUESTIONS AND COMMENTS, IF THAT IS OKAY WITH YOU, OR UNLESS YOU HAVE SOMETHING ELSE TO SAY AS A PREFACE TO THOSE. >> I THINK THAT'S AN APPROPRIATE STRATEGY, THANK YOU. SO WE'LL HOLD COMMENTS. I'LL BE WATCHING THE RAISED HANDS BUT WE'LL ALLOW MARK TO GO THROUGH THE DOCUMENT AND THEN COME BACK AND IF PEOPLE HAVE QUESTIONS OR CHANGES OR COMMENTS, WE CAN GO TO THE LINE MEMBERS AS A SECOND PASS. >> GREAT. THANK YOU, STEPHEN. SO LOOK AT THE LINE NUMBERS BECAUSE THAT WILL ALLOW US TO DISCUSS THESE THINGS AS WE -- AND I'LL TRY TO FLAG THE LINE NUMBERS AS I'M GOING THROUGH IT. THE FIRST PAGE, AND DOWN TO LINE 60, I'M GOING TO SKIP OVER BECAUSE IT'S BASICALLY A INTRODUCTION AND A SUMMARY OF THE CONTEXT OF THE NIH DRAFT DATA SHARING POLICY. REMEMBER THAT THE NIH DATA SHARING POLICY IS LIMITED TO STUDIES THAT ARE FUNDED BY NIH. SO IT DOES NOT REACH STUDIES THAT ARE FUNDED BY DOD OR DOE OR NSF OR PRIVATE FOUNDATIONS. HOWEVER, BECAUSE OF THE -- AS I OFTEN OBSERVE TO THE PROVOST AROUND THE COUNTRY AT UNIVERSITIES AND THE BPs FOR RESEARCH, WE ARE ALL BAFFLED STATES OF THE NIH BECAUSE OF THE FUNDING POWER OF THE NIH AND THE NAIS WHICH WE DEPEND ON NIH FUNDING FOR RESEARCH. THEREFORE, WHAT THE NIH DOES, IT SETS A PRECEDENT AND OFTEN FOLLOWED AS I THINK YOU KNOW, BY OTHER FUNDERS LIKE NSF, OTHER GOVERNMENT FUNDERS AND ALSO PRIVATE FUNDERS. SO IF YOU LOOK AT LINE 62, THE FIRST ISSUE IS AN ISSUE WHICH THE NIH HAS DEALT WITH IN ITS POLICY THAT IS IN PLACE FOR THE SHARING OF GENOMIC DATA. THAT IS THE IDEA THAT PEOPLE WHO ARE THE HUMAN SOURCES OF DATA, THAT IT IS OPTIMALLY THEY OUGHT TO BE INFORMED THAT THEIR DATA WILL BE USED DOWNSTREAM FOR DATA SHARING PURPOSES AND FOR SECONDARY RESEARCH PURPOSES. AND PART OF THAT IS THE INSISTENCE THAT WE BELIEVE THAT IF THERE ARE SPECIFIC LIMITATIONS IN THE WAYS, IN THE CONTEXT IN WHICH THE DATA, THE HUMAN DATA WERE ORIGINALLY COLLECTED, THEN THE INVESTIGATORS WHO ARE SEEKING TO SHARE THOSE DATA OR TO ACCESS THOSE DATA SHOULD TAKE A COUNT OF THE SPECIFIC LIMITATIONS THAT WERE IMPOSED ON THE USE OF THE DATA WHEN THE DATA WERE FIRST COLLECTED. IN OTHER WORDS, PROMISES MADE TO INDIVIDUAL HUMAN SOURCES OF DATA, WHETHER THEY ARE HUMAN SOURCES IN THE CLINICAL CARE SETTING OR THE SOCIAL SERVICE SETTING OR THE RESEARCH SETTING, THAT THOSE SPECIFIC PROMISES REALLY OUGHT TO BE HONORED. AND SO IF YOU LOOK ON LINE 74-281. I'LL READ THIS. SACHRP BELIEVES THAT THE POLICY SHOULD MAKE CLEAR THAT INVESTIGATORS SHOULD CAREFULLY EVALUATE THE UNDERLYING CONSENT OF DATA DERIVED FROM HUMAN PARTICIPANTS AND ENSURE COMPLIANCE WITH LIMITATIONS CONTAINED IN SUCH CONCEPT AS PART OF THEIR PLAN. WHEN I SAY PLAN, REMEMBER THAT THE OPERATIVE WAY -- THE WAY THE DRAFT GUIDANCE POLICY WILL WORK, IS THAT THE INVESTIGATOR, RESEARCH TEAM, PRINCIPAL INVESTIGATOR AND HIS OR HER RESEARCH TEAM MEMBERS, THEY WILL NEED TO PROPOSE A DATA SHARING PLAN AS PART OF THEIR APPLICATION FOR FUNDING TO THE NIH. SO, THEREFORE, WHEN I TALK ABOUT THE PLAN, THIS MEANS THE STUDY-SPECIFIC PLAN FOR THE HOW THE DATA THAT ARE GENERATED IN THAT STUDY WILL BE SHARED BY THE INVESTIGATORS AND THE INVESTIGATORS INSTITUTION. SO WHAT THIS IS BASICALLY SAYING IS THAT THE INVESTIGATORS WHO ARE PROPOSING A PLAN OR DRAFTING A PLAN AS PART OF THEIR FINALIZATION OF THEIR APPLICATION FOR FUNDING TO THE NIH, WILL NEED TO EVALUATE AND CONSIDER AND ACCOMMODATE ANY SPECIFIC PROMISES OR LIMITATIONS WERE MADE TO THE DATA SOURCES. FURTHER, ON LINE 77, NIH SHOULD CONSIDER IMPLEMENTING A MEANS TO TRACK SUCH LIMITATIONS OR REQUIRE DOWNSTREAM USERS TO ENTER INTO DATA USE AGREEMENTS THAT IS DATA USE AGREEMENTS WITH THE ORIGINATORS OF THE DATA AND THEIR INSTITUTION SO THAT SUBSEQUENT DATA REQUESTERS ARE MADE AWARE OF SHARING LIMITATIONS AND HELD ACCOUNTABLE FOR UNAUTHORIZED FUTURE USES OF DATA DERIVED FROM HUMAN PARTICIPANTS. IF YOU GO TO LINE 100, REMEMBER -- AND THE DISCUSSION APPROXIMATELY LINES 83-100. REMEMBER THAT -- AND I KNOW WE HAVE OUR COLLEAGUES FROM OCR ON THE PHONE HAVE JURISDICTION OVER HIPPA. REMEMBER AS PART OF THE HIPPA PRIVACY RULE THAT IT IS A REQUIREMENT THAT COVERED ENTITIES MAKE AVAILABLE TO THE DATA SUBJECTS THOSE WHOSE PHI WILL BE HELD AND PROCESSED BY THE COVERED ENTITIES. IT'S REQUIRED THE COVERED ENTITIES MAKE AVAILABLE TO THOSE INDIVIDUALS A SO-CALLED NOTICE OF PRIVACY PRACTICES THAT GIVES THEM FAIR NOTICE AT A LEVEL OF NOT GROSS SPECIFICITY BUT SOME SPECIFICITY, HOW THEIR DATA WILL BE USED FOR TREATMENT TIME AND OPERATIONS AND RELATED PURPOSES. SO WHAT WE DISCUSSED IS THAT WE NOTE WHEN DATA ARE COLLECTED BY A COVERED ENTITY, WHETHER IN THE COURSE OF STANDARD CARE TREATMENT OR IN THE COURSE OF STANDARD OF PROCESSING OF HEALTH CLAIMS BECAUSE HEALTH SENTENCER ENTITIES ARE COVERED OR WHETHER IT'S A COVERED ENTITY COLLECTING DATA, PHI THROUGH RESEARCH OPERATIONS THAT IS THROUGH RESEARCH STUDIES; THAT IS IT IMPORTANT THAT THOSE ENTITIES INCLUDE IN THEIR NOTICE OF PRIVACY PRACTICES AS AN ETHICAL MATTER, EVEN IF NOT LEGALLY REQUIRED, SOME NOTICE TO THE SUBJECTS OF THE DATA THAT THEIR DATA, ONCE NONMIZED OR DEIDENTIFIED, MAY BE USED FOR ADDITIONAL RESEARCH PURPOSES FOR SECONDARY RESEARCH PURPOSES, MAYBE GIVEN TO OTHER ENTITIES AND RESEARCHERS. AND THAT EVEN IDENTIFIABLE INFORMATION MAY IN FACT BE USED WITHOUT SPECIFIC AUTHORIZATION OR CONSENT FROM THE INDIVIDUALS UNDER VARIOUS PATHWAYS, INCLUDING FOR EXAMPLE, SOME OF THE PATHWAYS THAT HAVE -- IN HIPPA, SOME OF WHICH HAVE BEEN REFERRED TO AND ALLUDED TO AND IN CORPORATEIATED INTO THE COMMON RULE. MOST IMPORTANTLY, THAT ONE CAN HAVE, FOR EXAMPLE, LIMITED DATASETS SHARED WITHOUT INDIVIDUAL CONCEPT. ONE CAN ALSO HAVE A WAIVER OF CONSENT AND AUTHORIZATION TO SHARE DATA BASED UPON THE RULING OF AN IRB OR PRIVACY BOARD THAT PRIMARILY DEPENDS ON A JUDGMENT OF MINIMAL RISK TO THE DATA SUBJECTS AND ALSO THE IMPACTABILITY OF GETTING INDIVIDUAL CONSENT FROM PEOPLE. SO IF YOU LOOK AT -- THE BOTTOM LINE HERE IS THAT THE -- ON LINES 100-107, SACHRP BELIEVES THE POLICY SHOULD PROMOTE TRANSPARENCY AND NOTICE OF PRIVACY PRACTICES AND SIMILAR STATEMENTS OF INSTITUTIONAL PRACTICES REGARDING SUBSEQUENT RESEARCH USES OF CLINICAL DATA SO PATIENTS MAY BE AWARE OF DATA SHARING FOR FUTURE RESEARCH PURPOSES. NIH IN COLLABORATION WITH OCR PROVIDE ADDITIONAL GUIDANCE IN THE FORM OF STANDARD TEXT OR TEMPLATES THAT WOULD ASSIST INVESTIGATORS AND INSTITUTIONS IN DEVELOPING UPDATED CONSENT AND NOTICE DOCUMENTS THAT CONFORM TO THE NIH POLICIES EXPECTATION THAT THERE OUGHT TO BE BROAD DATA SHARING AND THAT BROAD DATA SHARING IS A POSITIVE GOOD FOR SCIENCE AND FOR PUBLIC POLICY. TO CONTINUE, REMEMBER THIS IS ON LINES 109-126. IN GENERAL, UNDER HIPPA AND ALSO UNDER THE COMMON RULE, ONCE DATA HAVE BEEN TRULY DEIDENTIFIED OR NONMIZED RESPECTIVELY, THEN THE PARTICIPANTS IN GENERAL -- THOSE DATA ARE REGARDED AS NOT IDENTIFIABLE, NOT TRACEABLE TO A HUMAN SUBJECT, NOT DEALING WITH OR REGARDING HUMAN SUBJECTS AT THAT POINT IN MOST CASES, UNLESS THERE ARE PARTICULAR WAYS IN WHICH DEIDENTIFIED INFORMATION CAN BE TRACED TO THE ONE INDIVIDUAL OR A SMALL DEFINED SET IS OF INDIVIDUALS. AND REMEMBER THEREFORE THE DATA SUBJECTS, ONCE THEIR DATA ARE ANONMIZED, THEY NO LONGER HAVE ANY CONTROL OR RIGHTS RESPECTING THEIR DATA. HOWEVER, WHEN IDENTIFIABLE INFORMATION HAS BEEN COLLECTED AS PART OF A RESEARCH STUDY THAT INDIVIDUALS DO HAVE THE RIGHT F THEY WISH, TO REVOKE THE AUTHORIZATIONS FOR FUTURE USE OF DISCLOSURE OF THEIR PHI FOR RESEARCH PURPOSES AND REMEMBER THAT ONCE IDENTIFIABLE INFORMATION HAS BEEN PASSED ON TO OTHER RESEARCHERS UNDER THE COLOR OF LAW OF AN AUTHORIZATION, THAT HAS BEEN ENTERED INTO OR AGREED TO BY THE SUBJECT AS PART OF THE PRIMARY RESEARCH STUDY, THEN ONE OF THE REQUIREMENTS IS THAT INDIVIDUALS BE TOLD THEY REVOKE THEIR AUTHORIZATION THAT IT WILL AFFECT THE COLLECTOR OF THE DATA BUT IT WILL NOT AFFECT THE ENTITIES THAT ALREADY RECEIVED THE DATA THROUGH DATA SHARING MECHANISMS. SO, IT'S SOMEWHAT OBSCURE POINT BUT QUITE IMPORTANT AND THE IT'S SOMETHING THAT WE OFTEN FIND OURSELVES TALKING ABOUT WITHIN IRBs. SO, THE RECOMMENDATION HERE ON LINE 127, SACHRP BELIEVES THE 308 SEE OR SUPPLEMENTAL GUIDANCE SHOULD PROVIDE INVESTIGATORS WITH CLEARER GUIDELINES ON HOW TO MAKE CLEAR TO HUMAN PARTICIPANTS, THEIR RIGHTS TO MAINTAIN ANY CONTROL OF THEIR DATA WHETHER DEIDENTIFIED OR NOT ONCE SUCH INFORMATION HAS BEEN SHARED WITH DOWNSTREAM USERS, IS EXTREMELY LIMITED. PARTICIPANTS SHOULD BE INFORMED OF MECHANISMS THROUGH WHICH THEY MAY THEMSELVES STEEK MAKE THEIR DATA AVAILABLE TO THIRD PARTY RESEARCHERS. AND THE LAST IS ABOUT TOWARDS VARIOUS DISEASE ADVOCACY GROUPS THAT RATHER THAN OPPOSING DATA SHARING, THEY HAVE EMBRACED DATA SHARING BECAUSE THEY WOULD LIKE THEIR DATA TO BE SHARED WITH OTHER RESEARCHERS AND SO REMEMBER THAT A COVERED -- SO WHAT THIS ALLUDE TO IS THE UNDERLYING PRINCIPAL IN HIPPA THAT AN INDIVIDUAL WHO IS A DATA SUBJECT CAN DIRECT THE HOLDER OF DATA, THE COVERED ENTITY, TO RELEASE DATA, THE PHI, TO SPECIFIC NAMED PARTIES OR INDIVIDUALS AND THE ENTITY, COVERED ENTITY IS REQUIRED TO HONOR THOSE OBLIGATIONS. SO OVERALL, WHAT WE ARE TRYING TO DO ON LINES 109-132 IS TALK ABOUT THE POSITIVE RIGHTS AND THE NEGATIVE RIGHTS IMPLICATION FOR THE SUBJECTS FOR DATA SUBJECTS ESPECIALLY IN HIPPA CONTEXT. SO TO PROCEED ON PAGE 4, LINE 137, REMEMBER THAT -- THERE HAVE BEEN A NUMBER OF STUDIES BY LATONYA SWEENEY AT HARVARD AND RESEARCHERS WHO ARE BASED IN ISRAEL AND OTHERS, THAT IT BASICALLY HAD TAKEN DEIDENTIFIED DATASETS AND THEY HAVE BEEN ABLE TO ACCESS IDENTIFIED DATASETS THAT ARE IN MANY CASES PUBLICLY OR SEMI-PUBLICLY AVAILABLE AND THEY HAVE BEEN ABLE BY TRIANGULATING DEIDENTIFIED DATA OFF THE IDENTIFIED DATASETS AND THE PUBLICLY AVAILABLE DATASETS, THEY HAVE BEEN ABLE TO RE-CREATE MANY IDENTITIES OF PEOPLE WHICH LED MANY OF US TO QUESTION THOSE RESEARCHERS TO QUESTION, THE REAL EFFICACY OF CURRENT DEIDENTIFICATION STRATEGIES. AND SO, ONE OF THE -- AND THE DATA SHARING CONTEXT, MOST DATA THAT ARE SHARED ARE THEORETICALLY DEIDENTIFIED OR ANONMIZED WHETHER UNDER THE GENERAL POLICY IN PLACE WITH THE NIH OR WHETHER IT'S SUBJECT TO DATA SHARING THAT OCCURS BECAUSE OF CERTAIN JOURNALS REQUIRE THE DATA, PRIMARY DATA BE SHARED IN A DEIDENTIFIED FASHION. SO THE CONCERN HERE IS THAT DEIDENTIFICATION MIGHT NOT ACTUALLY BE SUFFICIENT PROTECTION. SO ON LINE 140, SACHRP RECOMMENDS THE POLICY PROVIDE MINIMUM STANDARDS THAT INVESTIGATORS SHOULD MEET OR SURPASS WHEN DEIDENTIFY DATA DERIVED FROM HUMAN PARTICIPANTS. AGAIN, WE DON'T SAY WHAT THAT SHOULD BE. WE ARE COMMENDING TO NIH'S ATTENTION THE NEED NOW OR LATER TO HAVE SOME PRINCIPLES OR STANDARDS THAT ARE STATED THAT WOULD PROVIDE SOME ADDITIONAL PROTECTION AND GUIDANCE REALLY FOR PREDICTION FOR GUIDENESS FOR THE INVESTIGATORS. ON LINE 151, MAKE NOTE OF THE POTENTIAL FOR IDENTIFICATION AND CONSIDER THE RISK OF REIDENTIFICATION FOR THEIR PARTICULAR DATASETS AS THEY FORMULATE THEIR OWN DATA SHARING PLANS TO THE EXTENT THAT AN INVESTIGATOR'S PLAN INCLUDES PUTTING IN PLACE THE DATA USE AGREEMENT, THAT IS AN AGREEMENT WITH THE ENTITIES AND PERSONS WITH WHOM THE DATA ARE SHARED. NIH SHOULD REQUIRE SUCH AGREEMENTS TO INCLUDE A PROVISION IN WHICH THE DATA RECIPIENT AGREES NOT TO ATTEMPT TO IDENTIFY INDIVIDUALS WHO ARE SUBJECTS OF THE DATA. THAT SEEMS STRAIGHTFORWARD BUT IT'S NOT CLEARLY STATED IN THE EXISTING NIH DATA SHARING DRAFT POLICY. THAT IS NOT BECAUSE NIH IS NOT CONCERNED ABOUT THESE THINGS, BUT RATHER BECAUSE THE NIH DATA SHARING POLICY ABOUT ANIMAL DATA, BENCH SCIENCE DATA AND HUMAN DATA. WHAT WE ARE DOING IN THIS PROCESS, I SHOULD HAVE SAID AT THE BEGINNING, WE ARE TRYING TO LOOK AT THE HUMAN SUBJECTS IMPLICATIONS OF THE DATA SHARING POLICY WHICH IS MUCH BROADER AND ALSO INVOLVES FOR EXAMPLE SHARING OF BENCH SCIENCE DATA AND ANIMAL DATA. WE ARE TRYING TO MAKE IT MORE SPECIFIC. ON LINE 162, SACHRP BELIEVES A CLEAR ARTICULATION OF STANDARDS AND HOW TO IMAGERY IDENTIFICATION RISKS WOULD CREATE A BASELINE OF HUMAN RESEARCH PROTECTIONS, THE POLICY SHOULD IDENTIFY COMMON DATA TYPES THAT INVESTIGATORS SHOULD CONSIDER EXCLUDING UNLESS SHARING OF SUCH INFORMATION IS OTHERWISE CONCEPTED TO BY THE INDIVIDUALS IN CONSIDERATION OF THE REIDENTIFICATION RISKS. NOW, THEN IN THE NEXT SECTION, WE TALK ABOUT THE RISK OF IDENTIFICATION NOT SO MUCH OF SPECIFIC INDIVIDUALS BUT RATHER OF DEFINED, DISCRETENESS OR MINORITIES WHO MAY BE ABLE TO IDENTIFIED AND CHARACTERIZED BY THE USE OF DATA THAT HAVE BEEN SHARED IN A WAY THAT IS REALLY QUITE IDENTIFIABLE. AND I WON'T GO INTO THE BACKGROUND IN REGARD TO THE CASE, BUT THAT IS ONE EXAMPLE OF WHEN THIS COULD OCCUR. REMEMBER THAT MOST OF THE -- AND I HAVE A SUPI CASE -- THE FACTS ARE UNCLEAR BECAUSE THE SHARING OF THOSE DATA WON'T FOR SO LONG AND WENT THROUGH SO MANY HANDS BUT IN MOST CASES, ACCORDING TO WHAT I UNDERSTAND FROM THE FACTS OF THAT CASE, THE REUSE OF THE DATA ACTUALLY WERE DONE UNDER COLOR OF LAW BECAUSE IRBs DID WAIVE CONSENT. AND THEREFORE -- BUT THERE WERE PROBLEMS IN THE -- DEPENDS ON WHAT YOU THINK THE REGULATORY STANDARDS ARE THE PROBLEM OR THE APPLICATION OF THE STANDARDS WAS THE PROBLEM, BUT THE POINT HERE IS THAT THERE IS RISK EVEN IN DEIDENTIFIED DATA OF THE ABILITY TO PIN THOSE DATA ON SMALL DEFINED GROUP INDIVIDUALS. SO, ON LINE 183, WHILE BROAD SHARING OF DATA MAY BE BENEFICIAL, SACHRP BELIEVES CIRCUMSTANCES IN WHICH THE SHARING OF CERTAIN DATA MAY INCREASE THE RISK OF HARM TO HUMAN PARTICIPANTS FOR POPULATIONS WITH UNIQUE SENSITIVITIES SUCH AS THOSE HISTORICALLY BEEN THE SUBJECT OF DISCRIMINATION OR LACK OF EFFECTIVE REPRESENTATION IN THE POLITICAL PROCESS OR SEPARATE DIGNITARY HARMS AS THE RESULT OF THE USE OF THEIR DATA FOR THE RESEARCH PROJECTS. THE POLICY SHOULD PROVIDE ADDITIONAL GUIDANCE TO SHARE CERTAIN DATA DERIVED FROM SMALL OR UNDER SERVED POPULATIONS. THE POLICY COULD GIVE EXAMPLES OF ACCEPTABLE AND PRUDENT LIMITS ON DATA SHARING TO SIGNAL TO INVESTIGATORS THE TYPES OF DATASETS AND POPULATIONS THAT WOULD EXPERIENCE A HIGHER RISK OF HARM IF REIDENTIFICATION WERE TO OCCUR. THE POLICY SHOULD CLEARLY AR IT TICK LATE PLANS SHOULD BE CRAFTED BY THE PRIMARY INVESTIGATORS WHO ARE SEEKING FUNDING FROM NIH SHOULD BE CAREFULLY CRAFTED TO MITIGATE SUCH RISKS OR PRESERVE THE ABILITY FOR MEMBERS OF THE POPULATIONS TO CONSENT TO THE SHARING OF THEIR DATA, PARTICULARLY IF THEY WANT THEIR DATA SHARED AS IN A RARE DISEASE POPULATION. THE NEXT SECTION IS IN REGARD TO GENOMIC DATA. GENOMIC DATA UNDER HIPPA RIGHT NOW, IF THEY ARE SHARED OF OTHER PHENOTYPIC DATA, LINE 197 -- THOSE DATA ARE CURRENTLY REGARDED AS IF SHED OF ALL THE 18 IDENTIFIERS UNDER -- DEFINED BY HIPPA IN THE DEIDENTIFICATION SAFE HARSH OR. GENOMIC DATA ARE REGARDED AS DEIDENTIFIED AND THEREFORE NOT AS PHI, FOR EXAMPLE. THE PROBLEM HERE IS THAT THE AVAILABILITY OF SOME GENOMIC DATABASES THAT DO HAVE ELEMENTS THAT MIGHT BE IDENTIFIABLE TO INDIVIDUALS BECAUSE THEY POSSESS A DEMOGRAPHIC OR PHENOTYPIC DATA IN ADDITION TO THE GENOME OR EXOME SEQUENCES, THAT THOSE MIGHT BE -- MIGHT PROVIDE THE ABILITY FOR REUSERS OF DATA ONCE THE DATE AT HAVE BEEN SHARED FOR REIDENTIFIED THE HUMAN SOURCES. SO, IN CONSIDERATION OF THIS ON LINE 204, SACHRP BELIEVES THE POLICY OR SUPPLEMENTAL GUIDANCE SHOULD STATE THAT IN THE CONTEXT OF NIH FUNDED RESEARCH AND THE PURPOSE OF THE POLICY, THE UNIQUE NATURE OF GENOMIC DATA SHOULD BE REGARDED AS PRECLUDING DEIDENTIFICATION AROUND ANONYMIZATION AS SUFFICIENT JUSTIFICATION FOR SHARING OF THE GENOMIC DATA WITHOUT CONSENT AND SAFEGUARDS SHOULD BE CONSIDERED WHEN INVESTIGATORS GENOMIC DATA UNDER THE DATA SHARING POLICY UNDER THE PLAN THAT HAS BEEN SUBMITTED BY THE INVESTIGATOR TO THE NIH. SUCH POSITIONS WOULD BE CONSISTENT WITH NIH'S OWN GENOMIC DATA SHARING POLICY. FURTHER CONSENT DOCUMENTS FOR PARTICIPANTS PROVIDING GENOMIC DATA THAT ARE TO BE SHARED SHOULD INCLUDE A STATEMENT ON THE UNIQUE ABILITY FOR SUCH DATA TO BE SAFEGUARDED THAT MIGHT BE ADDED BY INVESTIGATORS TO PROTECT THE DATA FROM REIDENTIFICATION. SO CONTINUING ON LINE 217. THIS IS TRYING TO ILLUSTRATE FROM 217-249. IT'S INDICATING AN AFFIRMATIVE VALUE IN ATTEMPTS TO PUT LIMITATIONS, CONDITIONS AND TERMS ON THE SHARING AND THE REUSE OF DATA THAT ONCE THEY HAVE BEEN SHARED IN ORDER TO PROTECT INDIVIDUALS, PROTECT THE HUMAN SOURCES OF THESE DATA. SO IF YOU LOOK -- WE ADDRESS IN HERE THE ISSUE OF -- IT WAS SAID IN OUR DISCUSSION AND THE REASONS I JUST SAY THE REASON IT IS IN HERE IS THAT IN THE DISCUSSION, IT WAS SAID THE NIH NOW HAS THE CERTIFICATE OF CONFIDENTIALITY ISSUED TO ALL NIH STUDIES SO THAT SHOULD SOLVE THE PROBLEM. IT DOESN'T SOLVE THE PROBLEM AND WE DID SOME SIGNIFICANT LEGAL RESEARCH ABOUT THIS BECAUSE UNDER THE CERTIFICATE OF CONFIDENTIALITY REQUIREMENTS, EVEN THE DATA THAT ARE UNDER A CERTIFICATE ARE ALLOWED TO BE SHARED IF THE SHARING OF THEM AND THE REUSE OF THEM IS IN COMPLIANCE WITH APPLICABLE FEDERAL REGULATION GUIDING THE SUBJECTS IN RESEARCH. SO IF YOU LOOK ON LINE 234, GENOMIC INFORMATION SHED OF ALL 18 HIPPA IDENTIFIERS COULD BE FURTHER SHARED DESPITE THE EXISTENCE OF THE CERTIFICATE BECAUSE THE SHARING OF DEIDENTIFIED GENOMIC INFORMATION FALLS OUTSIDE OF THE FEDERAL COMMON RULE WHICH GOVERNS THE USE OF ONLY IDENTIFIABLE PRIVATE INFORMATION. SO THE RECOMMENDATION HERE ON LINE 240, SENSITIVE DATA, PARTICULARLY THOSE DERIVED FROM HUMAN PARTICIPANTS MAY BE MORE SAFELY SHARED BY REQUIRING THE IMPLEMENTATION OF CONTROLLED ACCESS MEASURES. FOR EXAMPLE, NIH MAY CONSIDER REQUIRING DATA REQUESTERS TO AGREE TO TERMS AND CONDITIONS. THAT'S THE PERSONS AND ENTITIES THAT ARE REQUESTING THAT THE PRIMARY DATA BE SHARED WITH THEM FOR THEIR REUSE. THE NIH SHOULD CONSIDER REQUIRING THOSE REQUESTERS TO AGREE TO TERMS AND CONDITIONS UNDER WHICH THE REQUESTER MUST PROTECT DATA PRIVACY, REFRAIN FROM IDENTIFYING INDIVIDUAL PARTICIPANTS AND NOT SHARE DATA OUTSIDE THOSE WHO ARE LISTED IN THE DATA ACCESSORY QUEST. SO WE DON'T HAVE SUCCESSIVE SHARING, SHARING WITH NO ONE REMEMBERING WHAT THE ORIGINAL TERMS AND CONDITIONS WERE AND WITH THE SUBSEQUENT ENTITIES AND RESEARCHERS WITH WHOM DATA HAVE SUBSEQUENTLY BEEN SHARED NOT BEEN SUGGEST TO THOSE KIND OF TERMS AND CONDITIONS. LINE 246, PARTICULARLY SENSITIVE DATA ACCESS COULD ALSO BE CONTROLLED BY CREATING A SANDBOX ENVIRONMENT THAT IS A PORTAL IN WHICH LEGITIMATE REQUESTERS MAY ACCESS AND MANIPULATE DATA AND DO THEIR RESEARCH WITHOUT ACTUALLY ATTAINING THE UNDERLYING DATASET. SO, AND THUS SO DATA SHARING WOULD BE RESPECTED AS A PRINCIPAL. SECONDARIESY RESEARCHERS WOULD BE ABLE TO GET THE DATA BUT WOULDN'T BE ABLE TO TAKE WITH THEM A PORTABLE COPY OF THE DATA. MANY 69 PHARMA COMPANIES HAVE -- MANY OF THE PHARMA COMPANIES HAVE CREATED SANDBOX PORTAL ENVIRONMENTS AND IT CAN BE DONE EFFECTIVELY. THEN IN SECTION D, THIS IS PART OF A -- DEEPER DISCUSSION THAT HAS GONE ON FOR QUITE SOMETIME AND THAT IS THE NEED FOR THERE TO BE SANCTIONS FOR INDIVIDUALS WHO REQUEST AND OBTAIN DATA IN A DATA SHARING ENVIRONMENT AND THEN DON'T WERE THE TERMS AND CONDITIONS TO WHICH THEY AGREED. THERE HAVE BEEN A LOT OF CONVERSATION BUT NO REAL SERIOUS FEASIBLE LEGISLATIVE ACTION AT THE FEDERAL LEVEL OR EVEN AT THE STATE LEVEL OF WHICH I'M AWARE, THAT WOULD IMPOSE, FOR EXAMPLE, CRIMINAL SANCTIONS ON THOSE WHO ACQUIRE DATA SETS UNDER CONDITIONS OF WHICH IT IS CLEAR THEY ARE NOT SUPPOSED TO TRY TO REIDENTIFY OR RESELL OR PER HAVE A OR RESHARE DATA. BUT DOCUMENT AND CHANGE THE COMMANDS TO RECOMMENDS. I DON'T SEE IT AS A PROBLEM BUT I THINK THAT ALL OF THIS, ALL OF THESE PRINCIPLES, ESPECIALLY THOSE STATED IN BOLD TYPE ARE MEANT TO BE SACHRP RECOMMENDATIONS TO THE NIH. >> SO MY RECOMMENDATION WOULD BE TO USE THE WORD, RECOMMEND, AND JUST BE CONSISTENT THROUGHOUT SO THAT DOWN THE ROAD, PEOPLE DON'T START WONDERING ABOUT WHETHER THERE IS THE SUBTLE DIFFERENCES. >> THANK YOU. I SEE LESLIE RAISED HER HAND. >> THANK YOU FOR THE PRESENTATION AND CONTEXT. MUCH APPRECIATED. IT HELPED ME IN THINKING THROUGH THIS. I HAVE JUST A COUPLE OF MINOR COMMENTS. ONE THING I NOTICED, AND YOU SKIPPED OVER THE INTRODUCTION, BUT ON LINE 40-41, THERE IS THE MENTION OF THE SHARING OF DATA NEEDS TO BE OR SHOULD BE DICTATED BY THE APPLICABLE FEDERAL TRIBAL STATE AND LOCAL LAWS REGULATIONS STATUTES, GUIDANCE AND INSTITUTION OF POLICIES. AND MY COMMENT THERE WOULD BE THAT PROBABLY THAT MEANS A WHOLE LOT MORE THAN WE ARE ANTICIPATING HAVING DONE SOME OF THAT RESEARCH. JUST NOTING THAT IT'S INCREDIBLY COMPLICATED IN THAT CONTEXT. AND I DON'T KNOW THAT THAT MEANS ANY RECOMMENDATION OF ANY SUGGESTION -- ANY KIND, BUT JUST TO NOTE THAT, WHICH IS ONLY GOING TO MAKE RESPONDING IN ANY WAY MUCH MORE DIFFICULT. I HAD A QUESTION IN THE FIRST SECTION ON CONSENT TO DATA SHARING, CONTROL OF DATA, AND OUR RECOMMENDATION AT LINES 74 74-81. AND THE FOCUS OF THE WAY THAT RECOMMENDATION IS MADE IS RETROSPECTIVE LOOKING AT WHAT DOT CONSENT FORMS SAY, BUT AS THIS IS ALSO ABOUT RESEARCHERS MAKING PLANS WHEN THEY ARE COLLECTING DATA PROSPECTIVELY, IS IT WORTH ALSO EMPHASIZING THAT THEY SHOULD BE THINKING ABOUT THESE ISSUES AND INCLUDING WHETHER OR NOT THEY WANT TO THINK ABOUT DIFFERENT LIMITATIONS, GIVEN THE OTHER THINGS THAT ARE RAISED IN THIS DOCUMENT, MOVING FORWARD. >> I THINK THAT'S A GOOD POINT. I THINK A SUBS CAN BE INSERTED TO THAT EFFECT. I AGREE. I THINK THAT LINES 74-77, I THINK THE IMPLICATION THERE IS STATED AND PERHAPS THE IMPLICATION HERE IS THAT INVESTIGATORS WRITING THEIR OWN CONSENTS, NEED TO ANTICIPATE THESE ISSUES BUT I THINK THE WAY IT READS, IF I LOOK AT IT, IT IS MORE THEY ARE LOOKING AT PAST CONSENTS AND ANY LIMITATIONS ON THE CONSENT. AND I THINK -- >> MUCH OF HOW WE HAVE BEEN THINKING ABOUT THESE ISSUES MAKES TOTAL SENSE AND I THINK THAT REINFORCING THEY SHOULD BE THINKING ABOUT IT AND AGAIN, KEEPING IN MIND THE VARIOUS ISSUES THAT ARE ALREADY RAISED IN THIS DOCUMENT WILL HELP THEM THINK ABOUT THEIR CONCERNS MAY BE. ONLY OTHER THING THAT STRUCK ME IS IN THE SECTION ON EFFICACY OF DEIDENTIFICATION AND THE RECOMMENDATION AT 151-1PICKS, IS WHETHER IT IS -- 151-156, IN THE SECTION THAT TALKS ABOUT CERTIFICATES, AND I AGREE WITH YOUR SENSE THAT THEY ARE NOT SUFFICIENT AND THE CONCERNS YOU RAISED AND THE SUGGESTIONS YOU RAISED IN TERMS OF MAYBE ADDRESSING THAT IS THAT THEY ARE IN FACT, THOSE OBLIGATIONS FROM THE CERTIFICATE DO FOLLOW THE DATA IN THE WAY THE NEW CERTIFICATES -- AT LEAST REMINDING INVESTIGATORS, PARTICULARLY BECAUSE GIVEN THAT IT IS NOW AN AUTOMATIC ISSUE FROM NIH, I DON'T KNOW THAT INVESTIGATORS ALWAYS ARE AWARE OF THEM SO IT'S AN OPPORTUNITY FOR US TO REINFORCE THAT. THAT DOESN'T MEAN IT'S FULLY SUFFICIENT BUT IT'S A GOOD OPPORTUNITY. >> THAT PARTICULAR -- YOU'RE REFERRING TO ONE LINE BUT THE LINES THAT ARE DEALING WITH CERTIFICATE ARE REALLY 217-249. >> RIGHT. BUT I WAS LOOKING AT THE 151-156, BECAUSE IT REMINDED ME, THERE IS SOMETHING. AND THEN THE OTHER SECTION IS TALKING ABOUT, AND YET THAT'S NOT ENOUGH. SO THAT'S WHERE I THOUGHT IT MAY BE USEFUL. IT COULD BE BETTER THAT IT IS IN THE CONTEXT WHERE YOU'RE TALKING ABOUT CERTIFICATES MORE FULLY. I SEE CERTIFICATES EVERYWHERE. NOT EVERYBODY MAY THINK OF IT THERE AND IT MAY BE BETTER IN THE LOCATION THAT EVEN THOUGH THE PROTECTIONS FOLLOW THE DATA THAT THEY ARE NOT SUFFICIENT FOR THE REASONS YOU HAVE THERE. I'M AGNOSTIC AS TO LOCATION. >> YOU KNOW WHAT I MIGHT DO IS DROP A FOOTNOTE ON LINE 156 AND REFER TO THE LATER DISCUSSION OF THE CERTIFICATES, OKAY? >> WORKS FOR ME. >> OKAY. >> THANK YOU. WALTER? >> THANK YOU, STEPHEN. FIRSTLY, A VERY THOUGHTFULLY-DESIGNED DOCUMENT AND WELL PRESENTED. A COUPLE OF OBSERVATIONS. ONE THE FOCUS UPON THE RESEARCH PARTICIPANTS, INVESTIGATORS AND THEN RECIPIENTS OF INVESTIGATORS DATA. I THINK THAT THE FIRST PIECE WE HAVE TO RECOGNIZE IS THAT THIS FIELD IS A VERY DYNAMIC ONE. SO WHAT WAS DEIDENTIFIED DATA 10 YEARS AGO IS NO LONGER DEIDENTIFIED ON THE COUNT OF PROGRESS AND INFORMATION TECHNOLOGIES. I THINK WE CAN ASSUME THAT THIS IS GOING TO CONTINUE TO BE THE CASE. SO WE HAVE TO RECOGNIZE THAT THIS IS NOT A STATIC ISSUE. I THINK THERE IS AN OPPORTUNITY FOR RESEARCH PARTICIPANTS TO, AS BEST WE CAN, IN THE REVISED INFORMED CONSENT DOCUMENT THAT IS A COMPONENT OF THE REVISION TO THE COMMON RULE, TO REALLY THINK ABOUT DEVELOPING A HEALTH LITERATE SET OF STATEMENTS PERTAINING TO ANY POTENTIAL REUSE OF DATA. THERE IS IT A GOOD OPPORTUNITY THERE TO COMMUNICATE RISKS. IT'S GOING TO BE -- I THINK IT'S GOING TO BE -- IT MAY NOT BE SUFFICIENT IN THE LONG TERM BUT IT IS GOING TO BE THE BEST THAT WE CAN OFFER AT THE PRESENT TIME. INVEST GATORS ARE OFTEN REALLY UNAWARE OF THIS ISSUE. SOME WORKING IN GENOMIC DATA I THINK ARE MUCH MORE SENSITIVE TO IT THAN INDIVIDUALS WORKING IN BEHAVIORAL RESEARCH. BUT I THINK WE HAVE TO DO A BETTER JOB OF EDUCATING INVESTIGATORS, AND I THINK WHERE YOU HAVE LINES 162-164 REGARDING -- 164-166, IDENTIFYING COMMON DATA TYPES AND DEVELOPING ESSENTIALLY AN EXPECTED MINIMUM STANDARD. THAT WILL BE HELPFUL BECAUSE I THINK AGAIN, MANY INVESTIGATORS ARE JUST NOT SENSITIVE TO THIS ISSUE AND THEY SHOULD, HAVING SOME MINIMUM STANDARD WILL AT LEAST RAISE THE LEVEL OF EXPECTATIONS. AND THEN I AGREE WITH YOU, I DON'T HAVE THE PARTICULAR SECTIONS BUT I DO AGREE WITH YOU THAT THERE SHOULD BE SOME CONSEQUENCES FOR INAPPROPRIATE SHARING OF DATA. AND WE ARE ALL AWARE, AS WE THINK MORE ABOUT PUBLIC/PRIVATE PARTNERSHIPS, ONE THINKS ABOUT DATA THAT MAY BE USED FOR IN THE COMMERCIAL PURPOSES FAR FROM THE ORIGINAL INTENT OF THE COLLECTION OF THE DATA, AND IN SOME CASES, THOSE USES ARE VERY ALTRUISTIC. IN OTHER CASES, THEY MAY NOT BE. AND SO I THINK THAT FLUSHING OUT THE CONSEQUENCES OF INAPPROPRIATE USE OF SUCH DATA WOULD BE -- WOULD STRENGTHEN THE DOCUMENT. THOSE ARE A COUPLE OF KEY POINTS FOR CONSIDERATION. >> WALTER, ON THE LAST, CAN YOU TELL ME WHAT ADDITIONAL SPECIFICITY DO YOU THINK WOULD BE APPROPRIATE? I'M JUST TRYING TO OPERATIONALIZE WHAT YOU'RE SAYING. >> WELL, I'M THINKING ABOUT THE THE ISSUE OF INDIVIDUALS WHO MAY FACE DISCRIMINATION ON ACCOUNT OF THEIR DATA, OR WHAT HAD BEEN INTENDED TO BE DEIDENTIFIED DATA BEING IDENTIFIABLE AND BEING -- LOOKING AT THE NATIONAL SCENE IN TERMS OF OUR HEALTH CARE SYSTEM, THE QUESTION OF PRE-EXISTING CONDITIONS HAS ARISEN AGAIN. SO THE POSSIBILITY THAT INDIVIDUALS MAY FACE DISCRIMINATION ON THE BASIS OF PRE-EXISTING CONDITIONS IS ONE THAT I THOUGHT WE PUT TO BED A COUPLE OF YEARS AGO BUT IT IS AN ACTIVE TOPIC OF DISCUSSION IN WASHINGTON NOW. A. >> THANK YOU. LINDA, DO YOU WANT TO MAKE A SUGGESTION? >> SURE. I'LL GO AHEAD AND DO THAT. THIS IS JUST MINOR BUT I THOUGHT MAYBE WORTH MENTIONING. IT WOULD BE HELPFUL, I THINK, TO MAYBE DEFINE LIKE DEIDENTIFIED AND ANONYMIZE BECAUSE SOMETIMES I THINK PEOPLE GET CONFUSED WITH THOSE TERMS AND ALSO WE ARE USING -- I DID A SEARCH OF SENSITIVE DATA AND I KNOW WE GENERALLY KNOW WHAT THAT MEANS BUT I THINK IT WOULD BE SOMETIMES HELPFUL TO DEFINE WHAT WE MEAN. I KNOW THAT WE TALK ABOUT SENSITIVE INFORMATION AND DATA IN THE CONTEX OF SETTLER OF CONFIDENTLY, MAYBE THERE MIGHT BE -- CERTIFICATES OF CONFIDENTIALITY -- AND THEN IN LIGHT OF THE SECTION YOU ADDED REGARDING THE GDPR, EVEN THOUGH I KNOW -- I THINK YOUR INTENT IS NOT TO GO INTO A LOT OF DETAIL REGARDING THAT IN THIS DOCUMENT. THERE ARE SOME TERMS IN THOSE REGULATIONS THAT COULD ALSO BE CONFUSING AS WELL BECAUSE THEY ARE NOT TERMS THAT ARE CONSISTENT WITH DEIDENTIFIED AND ANONYMIZE. SO I THOUGHT THIS MIGHT BE HELPFUL TO KIND OF TEASE OUT A BIT. >> OKAY. THANKS. >> CONSUELO? >> FOLLOWING ALONG WITH THE DEFINITIONS, I WAS GOING TO SUGGEST THAT AS WELL. I THINK THAT WOULD BE HELPFUL. I ALSO WONDER IF SOME OF THE LANGUAGE BEING USED IS CONTRADICTORY. SO IF WE ARE ACKNOWLEDGING THAT FOR SOME POPULATIONS THE CURRENT WAY WE ARE DEIDENTIFYING IS NOT ACTUALLY DEIDENTIFYING FOR THEM, THEN DOES THAT BRING UP OTHER ISSUES THAT NEED TO BE DISCUSSED AROUND WHT IS DISCLOSED TO THEM ABOUT NOT BEING FULLY -- FULLY IS PROBABLY NOT WHAT WE WANT TO SAY. THAT OPENS UP A BIGGER CAN OF WORMS MAYBE ABOUT WHETHER YOU CAN FULLY DEIDENTIFY ANYONE. BUT DO WE NEED TO TALK ABOUT HOW TO DISCLOSE THAT TO INDIVIDUALS FROM SPECIFIC GROUPS WHO ARE AT HIGHER RISK OF BEING REIDENTIFIED? WHAT ADDITIONAL INFORMATION NEEDS TO BE DISCLOSED SPECIFICALLY TO THEM IN INFORMED CONSENT? AND I DO THINK THAT -- I APPRECIATE THE FOCUS ON GROUPS WHO MIGHT BE AT RISK FOR HIGH -- HIGHER RISK FOR DEIDENTIFICATION. I THINK THE LANGUAGE SEEMS TO SKIRT AROUND MINORITIES AND RACIALIZED GROUPS. WE SAID MINORITY A COUPLE OF TIMES. UNDER SERVED IS USED. IT'S NOT DEFINED. I THINK IT WOULD BE HELPFUL TO REALLY BE SPECIFIC OR EXPLICIT IN WHICH GROUPS OF PEOPLE WE ARE TALKING ABOUT. >> THANK YOU. >> WALTER IS YOUR HAND STILL UP? MARK, IF THERE ARE NO IMMEDIATE ABOUT THE USE OF THAT WORD, BICITATES. LET ME SEE IF I CAN FIND THE LINE -- DICTATES. THE LINE NUMBERS IN THE COPY IN MY COMPUTER ARE DIFFERENT. HERE IT IS. SHOULDN'T THAT BE GOVERNED? DO WE WANT IT TO BE DICTATED? THIS IS A POLICY THAT IS SUPPOSED TO ATTACK DATA SHARING. >> I MEAN, I CAN SAY THAT. THE POINT THOUGH, STEPHEN, IS THAT ANYBODY CAN WRITE ANYTHING THEY WANT TO IN THE DATA SHARING PLAN AND IF THE LAW DOESN'T ALLOW THEM TO DO IT, THE LAW GOVERNS. THE DATA SHARING PLAN FALLS BEFORE OTHER LAWS AND REGULATIONS. THAT'S THE REASON FOR THE STRONG USE OF THE WORD THERE. >> I MEAN, MAYBE EVEN, PRE-EMPTED? IT'S JUST, DICTATED SEEMS LIKE IT TAKES OVER THIS POLICY. >> OKAY. >> ANYWAY, IT JUST READ ODDLY TO ME WHEN I LOOKED TAT. >> OKAY. >> THE OTHER THING, AND IF NO ONE ELSE FOUND THIS CONFUSING, THEN IT'S FINE. YOU KNOW, YOU START WITH YOUR EXAMPLES AND LET ME FIND THE LINE. SO STARTING AT LINE 83. FURTHER UPON THE ADOPTION OF THIS POLICY, INVESTIGATORS AND INSTITUTIONS WILL NEED TO UNDERTAKE THE BURDEN -- AND THEN GO TO AN EXAMPLE, WHICH IS FROM THE CLINICAL SPACE AND NOT FROM THE REACH SPACE. SO NOT GOVERNED BY THIS POLICY. SO FOR EXAMPLE, IF THERE IS AN ORIGINAL CONSENT ASSOCIATED WITH MEDICAL TREATMENT, THE CONSENT OFTEN MAY NOT INDICATE OR STATE THE DATA COLLECTED DURING STANDARD OF CARE PROCEDURES MAY BE SUBSEQUENTLY A RESEARCH STUDY. AND I TOTALLY AGREE WITH THE IMPORTANCE OF MAKING THAT TRANSPARENT. BUT THE DATA SHARING COVERED BY THIS POLICY IS THE SHARING THAT WILL TAKE PLACE AFTER ITS USED IN THE RESEARCH STUDY. >> NO. I THINK I UNDERSTAND WHAT YOU'RE SAYING BUT REMEMBER THAT THIS IS THE PROBLEM WITHIN A PROBLEM WITHIN A PROBLEM. AND ORIGINAL RESEARCHER WHO WAS MAKING A PROPOSAL TO THE NIH, MAY IN FACT HIMSELF OR HERSELF BE RELYING UPON A CLINICAL DATASET THEY WANT TO USE IN THEIR DATA. IT IS ALREADY BEEN CREATED BEFORE THEIR RESEARCH EVER BEGINS. AND THEN ONCE THEY ANALYZE THOSE DATA, THEY WILL HAVE TO -- AND BE ASKED TO SHARE THOSE DATA EVEN IF THOSE DATA WERE NOT CREATED IN THE COURSE OF A PRIMARY RESEARCH STUDY. >> SO I UNDERSTAND THAT. TO ME, THE EXAMPLE READ LIKE THE EXAMPLE WAS ADDRESSING THE TRANSPARENCY IN THE FIRST STEP. WHEN THE RELEVANCE OF THIS POLICY IS TO THE SECOND STEP. SO, THE QUESTION OF SHARING CLINICAL DATA WITHOUT EXPLICIT ACKNOWLEDGMENT IS NOT REALLY A QUESTION FOR THIS POLICY. THIS POLICY ADDRESSES WHAT HAPPENS WHEN A RESEARCHER USING A CLINICAL DATASET SUBSEQUENT DOES THEIR RESEARCH WHICH FALLS UNDER DIFFERENT OVERSIGHT, AND THEN SHARE IT IS, WHICH IS UNDER THIS POLICY. I JUST FOUND THAT IT SOUNDS LIKE YOU'RE REFERRING TO THE INITIAL SHARING OF THE CLINICAL DATA FOR RESEARCH, WHICH I DON'T THINK IS THE INTENT. YOU'RE LOOKING FOR THE DOWNSTREAM SHARE. >> NO, I THINK WHAT WE ARE SAYING HERE IS BOTH. AND THAT IS THAT IF ENTITIES WHEN THEY ARE CREATING DATA, THAT ULTIMATELY THAT WILL BE USED FOR RESEARCH WHETHER IT IS STANDARD OF CARE CLINICAL DATA OR INTERVENTIONAL STUDIES OR REGISTRY STUDIES, THEY NEED TO UNDERSTAND THAT THEIR DATA WILL BE USED BY NIH-FUNDED RESEARCHERS AND THEY NEED TO ANTICIPATE RIGHT NOW THAT PEOPLE WHO ARE THE DATA SUBJECTS NEED TO BE TOLD THAT THEIR DATA WILL BE SHARED IN ORDER TO HAVE AN APPROPRIATE ETHICAL UNIVERSE THAT WILL PROMOTE AND FACILITATE THE DOWNSTREAM SHARING OF DATA. SO IT'S REALLY IMPORTANT FOR NOT JUST RESEARCHERS WHO ARE GOING TO SHARE DATA BUT FOR EVERYBODY WHO DOES STUFF TO CREATE THE DATA, THE ESSENTIAL DATA BEFORE THE PRIMARY RESEARCHER EVER GETS THEM. THAT'S THE REASON I THINK THIS IS IN HERE. AND SO I DON'T WANT TO TAKE AWAY FROM THE IMPORTANCE OF IT. I'M JUST TRYING TO THINK ABOUT HOW TO MAKE IT CLEARER. SO IT'S THE POSSIBILITY THAT CLINICAL DATA MAY BE SHARED AND THEN MAYBE USED FOR RESEARCH AND THEN SUBSEQUENTLY SHARED. I GUESS WHAT I'M GETTING HUNG UP, IS THE POLICY WE ARE COMMENTING ON DOESN'T SPECIFICALLY ADDRESS THAT FIRST STEP. IT'S THE SECOND STEP IT ADDRESSES. AND YET WHAT YOU'RE SAYING IS THAT'S A POSSIBILITY SO IN THE CONSENTS AND THE DISCLOSURES THAT POSSIBLY HAS TO BE EXPLICIT EXPLICIT. >> RIGHT. WHAT I THINK WE ARE SAYING TO NIH IS, YOU NEED TO THINK -- WE ARE SAYING, YOU NEED TO THINK MORE DEEPLY THAN JUST ABOUT INVESTIGATORS THAT ARE FUNDED BY YOU SHARING THEIR DATA BECAUSE THEY ARE ACQUIRING DATA FROM OTHER SOURCES AND IT'S IMPORTANT FOR YOU -- IF YOU, THE NIH, WANT DATA TO BE SHARED, WHICH IS WHY YOU HAVE THIS POLICY TO BEGIN WITH, YOU HAVE TO THINK MORE BROADLY ABOUT HOW YOU CREATE AN ETHICAL UNIVERSE IN WHICH YOUR INVESTIGATORS CAN HAVE GREATER ABILITY TO SHARE THEIR DATA. >> OKAY. I TOTALLY SUPPORT THAT. IT WASN'T ENTIRELY CLEAR. NO ONE ELSE HAD THAT CONFUSION. ANY OTHER COMMENTS OR CONCERNS WITH THE DOCUMENT? SO, TODD? >> THANK YOU. THIS IS TODD FROM NIH. IF NOBODY ELSE HAS ANY CONCERNS, I WANTED TO SAY A COUPLE OF THINGS ABOUT THIS. FIRST I WANTED TO SAY THANK YOU TO THE COMMITTEE FOR TAKING ON THIS TOPIC AND FOR LOOKING INTO THESE ISSUES. WE CERTAINLY REALLY APPRECIATE THIS AND ERG YOU'RE SAYING HERE I THINK. WE ARE VERY INTERESTED IN THIS AND WE ARE MOVING TOWARDS FINALIZATION OF THE POLICY, SO THIS IS A GREAT INTEREST TO US. WE GOT A PRETTY ROBUST RESPONSE TO THE COMMENT PERIOD SO THIS IS HELPFUL GOING THROUGH THE PUBLIC COMMENTS. A COUPLE OF POINTS OF CLARIFICATION THAT I WAS HOPING TO GET. SO I HAVE A COUPLE OF MINOR QUESTIONS BUT I WANTED TO MAKE ONE POINT, MOSTLY IN RELATION TO THE CONVERSATIONS. THE POLICY, I THINK, IS NOT NECESSARILY -- AND I JUST WANT THE DRAFTED THING TO SOME EXTENT WHEN IT COMES TO CONSENT AND DATA SHERRYING. SO FOR EXAMPLE, I THINK ON LINE, THE 5 OR IT TALKS ABOUT THE TYPE OF CONSENT NEEDED TO ACCOMMODATE THE TYPE OF BROAD DATA SHARING IN THE POLICY. AND I THINK THERE CAN BE PERHAPS% AN IMPLICATION COMING FROM THIS THAT NIH IS REQUIRING OR PERHAPS EXPECTING BROAD CONSENT TO BE OBTAINED IN ALL CASES SINCE THE POLICY WOULD SEEM TO EXPECT SOME LEVEL OF SHARING. BUT I THINK THAT IS NOT NECESSARILY IN THE POLICY OR IN THE DRAFT THAT WAS PUT FORWARD. THERE WASN'T SORT OF AN EXPECTATION TO TRY AND FORCE PEOPLE TO ADOPT BROAD CONSENT OR OBTAIN BROAD CONSENT. AND WE ARE AWARE THERE ARE CHALLENGES WITH THAT. AND I WANT TO EMPHASIZE ALSO THAT IF YOU LOOK AT THE SUPPLEMENTAL GUIDANCE WE PUT OUT, CERTAINLY WE WOULD ANTICIPATE LIMITATIONS IN CONSENT COULD BE A VALID REASON FOR NOT SHARING DATA AS WIDELY OR FULLY BROAD OR OPENLY. AND I THINK THIS DOCUMENT DOES GOAT THAT. I JUST WANT TO POINT OUT THAT IT ALSO AT SOME POINT SEEMS TO BE SUGGESTING WE ARE MOVING PEOPLE TOWARDS BROAD CONSENT AND I DON'T THINK THAT IS NECESSARILY -- >> CAN I JUST STOP RIGHT THERE? THERE IS NO -- YOU KNOW THAT I AM AN OPPONENT OF REGULATORY BROAD CONSENT. I HAVE WRITTEN ABOUT IT. I DIGS PIES IT. I THINK IT WAS BADLY CONCEIVED -- DESPISE IT. IT CONCERNS ME THAT IF YOU THINK ANYTHING IN HEAR COULD BE READ AS INDICATING WE SHOULD HAVE UNIFORM BROAD CONSENT, REGULATORY BROAD CONSENT. SO I WILL LOOK THROUGH THIS AND MAKE SURE THAT THERE IS NO SUCH IMPLICATION. >> OKAY. WELL, SO JUST TO THAT POINT THERE, AND YOU MIGHT WANT TO LOOK AT LINES 83-85. I'M NOT SURE HOW EVERYBODY WOULD READ IT. BUT IT CAME TO ME THAT WAY. AND THEN RELATED TO ONE OF THE OTHER QUESTIONS I WANTED TO -- >> LET ME JUST -- I THINK THAT WHAT I AM TRYING TO SAY IS THAT IT'S NOT THAT -- WHAT WE ALL WERE TRYING TO SAY IS NOT REGULATORY BROAD CONSENT SHOULD BE GAINED FROM INDIVIDUALS RATHER A CONSENT DOCUMENT SHOULD GIVE A GOOD INDICATION, HONEST INDICATION OF THE FACT THERE WILL BE DATA SHARING. THAT IS NOT BROAD CONSENT. IT'S GIVING PEOPLE INFORMATION ABOUT DATA SHARING. SO THAT IS WHAT IT IS MEANT TO SAY. AND I CAN CLARIFY THAT. ABOUT GO AHEAD, SORRY. >> SURE. AND I THINK THAT YOU MIGHT WANT TO LOOK AROUND 105 WHERE IT TALKS ABOUT CONSENT AND NOTICE AND IT DOES SAY, UPDATED CONSENT IN NOTICE DOCUMENTS CONFORMS TO THE POLICY EXPECTATIONS WITH BROAD DATA SHARING. TO YOUR POINT, IT'S NOT NECESSARILY SAYING IT IS EXPECTING BROAD CONSENT BUT -- >> OKAY. >> AND THEN I HAD A COUPLE OTHER QUESTIONS. MOSTLY JUST FOR CLARIFICATION. SO YOU TOUCHED ON THIS BRIEFLY BUT AT LINE 130 WHERE IT STATES THAT PARTICIPANTS SHOULD BE INFORMED OF MECHANISMS AND SEEK TO MAKE THEIR DATA AVAILABLE TO THIRD PARTY RESEARCHERS. I THOUGHT YOUR CLARIFICATION WAS HELPFUL. BUT JUST TO UNDERSTAND A LITTLE BIT BETTER. IS THIS REFERRING TO DATA THAT PARTICIPANTS MIGHT THEMSELVES BE IN POSSESSION OF THAT WASN'T NECESSARILY GENERATED DURING THE COURSE OF THE STUDY OR ARE WE REFERRING HERE TO THE DATA THAT WOULD BE GENERATED DURING THE COURSE OF THE STUDY?% BECAUSE IN THE FORMER CASE, IT MIGHT BE THE EHR WHICH I KNOW IS SOMETHING THAT MECHANISMS HAVE BEEN CREATED FOR PEOPLE TO BE ABLE TO VOLUNTARILY SHARE THAT. AND I'M JUST TRYING TO GET A SENSE OF IT, ARE YOU REFERRING MORE HERE TO WHERE IT'S COMING FROM THE STUDY? GENERATED BY THE STUDY? >> I THINK IT COULD BE EITHER. EITHER PARTICIPANTS PARTICIPATING IN THE STUDY AND THEY WANT THEIR DATA TO BE SHARED WITH ADDITIONAL SET OF RESEARCHERS. THAT'S ONE THING. THE OTHER WOULD BE A PERSON, FOR EXAMPLE N A RARE DISEASE COMMUNITY WHO MAY WANT HIS OR HER DATA SHARED WITH THIRD PARTY RESEARCHERS JUST THE STANDARD OF CARE DATA SHARED AND THEY DON'T POSSESS THE DATA BUT THE DATA IS IN THE POSITION OF THE SOCIAL SERVICE AGENCY OR INSTITUTION WHERE THEY RECEIVE THEIR CARE AND THEY WOULD LIKE TO SHARE. I MEAN, THIS IS PROBABLY MOST COMMON IN REAL LIFE IN THE RARE DISEASE COMMUNITY LIKE THE OTHERS IN WHICH THERE ARE A SET OF PATIENTS, FAMILIES THAT BAND TOGETHER AND THEY WOULD LIKE THEIR DATA COLLECTIVELY TO BE SHARED WITH A NEW SET OF RESEARCHERS AT A DIFFERENT INSTITUTION. SO THEY ASK THE INDIVIDUAL INSTITUTION WHERE THEY HAVE GENERALLY RECEIVED THEIR CARE TO PACKAGE THE DATA AND SEND THEM ON TO AN ADDITIONAL INSTITUTION OR RESEARCHER. >> OKAY. SO IS THE RECOMMENDATION THEN NIH IS INDICATING THE POLICY OR IN GUIDANCE THAT INVESTIGATORS SHOULD INFORM PARTICIPANTS DURING CONSENT ABOUT THE EXISTENCE OF THESE MECHANISMS OR IS THIS DIRECTED TO INVESTIGATORS THEMSELVES? >> I DON'T THINK IT'S -- IT'S NOT ABOUT NIH. I THINK THIS IS ABOUT THE NEED FOR I DON'T KNOW HOW IT IS OPERATIONALIZED. I DOUBT IT WOULD BE IN CONSENT BECAUSE MOST OF THE TIME THIS OCCURS, IT'S NOT ABOUT INDIVIDUALS WHO ARE UP IN A STUDY WANTING THE INVESTIGATOR TO RESHARE THEIR DATA. IT IS INSTEAD ABOUT A SITUATION IN WHICH DATA HAVE ALREADY BEEN COLLECTED AND NOW A GROUP OF PATIENTS OR FAMILIES WANT THEIR DATA OR BENEFICIARIES TO BE SHARED. AND SO, HOW WOULD THAT BE? I MEAN HOW WOULD THAT BE OPERATIONALIZED? I THINK IT WOULD BE USEFUL FOR NIH TO SAY SOMETHING ABOUT THAT IN THE POLICY. THAT WOULD BE USEFUL BECAUSE IT'S NOT SOMETHING THAT PEOPLE WOULD TEND TO KNOW ABOUT. IT'S ALSO NOT SOMETHING THAT RESEARCHERS SHOULD KNOW ABOUT. I THINK IT'S ALSO SOMETHING THAT OUGHT TO BE PERHAPS REFERRED TO IN A NOTICE OF PRIVACY PRACTICES AMONG COVERED ENTITIES. THERE ARE DIFFERENT WAYS OF OPERATIONALIZING THAT. REMEMBER THAT THIS DOCUMENT, THE REASON WE DO THESE DOCUMENTS IS NOT JUST BECAUSE WE ARE COMMENTING IN THIS CASE, TO NIH, BECAUSE NIH ASKED FOR COMMENTS. THESE DOCUMENTS BECOME PART OF PUBLIC RECORD AND PERFORM A FUNCTION JUST BY HAVING BEEN AUTHORED BY THIS COMMITTEE AND APPROVED AND SEPTEMBER TO THE SECRETARY. SO -- SENT TO THE SECRETARY. SO THE FACT THAT THERE ARE THINGS NOTED IN THESE DOCUMENTS IN WHICH THERE IS NO SPECIFIC RECOMMENDTION, WE MUST DO OR WE THINK THAT NIH OR ANYBODY ELSE MUST DO X, Y OR Z, DOESN'T MEAN WE DON'T SAY IT IN A DOCUMENT. >> RIGHT. THAT'S HELPFUL. OKAY. AND THEN I JUST HAVE ONE MORE QUESTION HERE WHICH IS AROUND LINE 267 AND THIS CONVERSATION REGARDING PENALTY. JUST WHETHER SORT OF THE COMMITTEE HAD ANY THOUGHTS ON THE SOURCE OF WHAT SOME OF THESE SANCTIONS MIGHT BE, WHETHER IT WOULD BE LIKE A LEGISLATIVE CHANGE OR SOMETHING ALONG THOSE LINES? >> I MEAN, WE TALKED ABOUT MANY DIFFERENT OPTIONS AND HAVE BEEN DEBATED AT OTHER MEETINGS AND PRIVATE AND PUBLIC CONVERSATIONS. I THINK A NUMBER OF US HAVE VOICED THE OPINION THAT THERE SHOULD BE SOME KIND OF GRADUATED SANCTION THAT WOULD START WITH -- IT'S NOT JUST A PRIVATE CAUSE OF ACTION BECAUSE THAT WOULD BE FOR THE AGREED PERSON TO HAVE A LT. AGAINST THE MISUSER OR ABUSER OF THE DATA -- LAWT -- BUT RATHER SOME AMOUNTY OF GOVERNMENT WHETHER IT'S HHS, OCR OR OHRP OR THE FUNDING AGENCY, OR EVEN A U.S. ATTORNEY TO BE ABLE TO SAY THAT -- TO IDENTIFY AN ABUSER OF DATA WHO CLEARLY HAS EXCEEDED WHAT HE OR SHE WAS ALLOWED TO DO OR THEIR INSTITUTION WAS ALLOWED TO DO WITH THE DATA IN A WAY THAT HARMED EVEN THE DIGNITY OR THE INTEREST OF THE INDIVIDUALS AND ASSESS AT THE BEGINNING, A FINE AGAINST THEM BUT GRADUATING ULTIMATELY FOR MALICIOUS USE OF DATA OR FOR THE CONVERSION OF DATA FOR-PROFIT USE LIKE IN THE HIPPA STANDARDS IN THE HIPPA CONTRACTUAL PROVISIONS RESULTING IN A CRIMINAL PENALTY. I THINK THAT IS -- IF WE AS A SOCIETY WANT TO BE SERIOUS ABOUT THIS, THAT IS WHAT WE WOULD DO. AND NOBODY WANTS TO -- I KNOW THAT PEOPLE IN GOVERNMENT DON'T WANT TO TALK ABOUT THIS BECAUSE I HAD THIS CONVERSATION WITH MANY OF YOU ON THE PHONE AND YOU ALL DON'T WANT TO DO IT BECAUSE YOU THINK OF IT AS A CONGRESSIONAL ACT. I UNDERSTAND THAT. YES, IT'S A CONGRESSIONAL ACT BUT IT DOESN'T MEAN THAT THE EXECUTIVE AGENCIES CAN'T VOICE THE NEED FOR SUCH A MEASURE AND CERTAINLY FOR US AS PRIVATE INDIVIDUALS AND INSTITUTIONS FROM ADVOCATING FOR IT. I THINK THAT IS JUST A LARGER CONTEXT FOR THE WHOLE IDEA. >> THANK YOU. THAT'S ALL THE QUESTIONS I HAVE. >> THANK YOU FOR YOUR COMMENTS. >> THANK YOU. AND I THINK THAT GAVE AN OPPORTUNITY TO REALLY ARTICULATE THE BROADER POTENTIAL IMPACT OF THE DOCUMENT, WHICH IS VERY USEFUL. OTHER COMMENTS BEFORE WE BREAK? SO MARK, ARE YOU THINKING THE CHANGES THAT ARE SUGGESTED ARE THINGS WE CAN GET TO DURING THIS MEETING? OR ARE THEY LIKELY TO REQUIRE MORE THOUGHT? >> WHAT I THINK I'M GOING TO TRY TO DO IS ACTUALLY DO THIS, TRY TO AMEND THIS TODAY SO WE CAN MAYBE TAKE IT UP EITHER AT THE END OF THE DAY TODAY OR TOMORROW. AND WHAT I'LL DO IS TAKE THIS VERSION AND DO A TRACK CHANGES VERSION AND THEN I THINK IF I COULD GET 15 MINUTES ON THE AGENDA, I THINK WE COULD CLEAN THIS UP AND HOPEFULLY THE COMMITTEE WOULD SEE ROOM TO APPROVE IT. BECAUSE NIH NEEDS IT. >> I THINK IT'S FAIR. SO LET'S TRY TO GET BACK TO IT TODAY, IF YOU'RE WILLING TO DO THAT WORK. THANK YOU VERY MUCH. >> SURE. >> AND AT THIS POINT, ONE LAST CALL FOR COMMENTS GIVEN MARK'S INTENT TO FINALIZE THIS OR GET THE COMMENTS INCORPORATED TODAY. IF THERE ARE NONE, WE HAVE A SCHEDULED BREAK FROM 12:30-1:00, GIVEN THAT'S THE OPPORTUNITY FOR MOST OF US TO HAVE LUNCH. I THINK THERE IS NO HARM IN STARTING A FEW MINUTES EARLY. WE'LL RECONVENE PROMPTLY AT 1:00 I THINK IT'S TIME TO GET STARTED. WE'RE GOING TO JUMP BACK IN TO DONOR INTERVENTION RESEARCH. RESEARCH. -- DDIR. GIVE ME A MOMENT TO GET ORGANIZED HERE. SO, FIRST OF ALL, WE HAVE BEEN DEALING WITH THIS TOPIC FOR ALMOST A YEAR AND A HALF AND THE EARLIEST DRAFT, I BELIEVE, WAS BEGUN BY MICHELLE LINE HORN AND THEN CONTINUED WITH WORK FROM NANCY KING, AND I'D LIKE TO THANK THEM BOTH. THIS HAS BEEN A GROUP EFFORT. AT THE LAST MEETING IN MARCH, WE HEARD FROM A PANEL OF TRANSPLANT RECIPIENTS AND ALSO FROM A TRANSPLANT SURGEON INVOLVED IN THIS TYPE OF RESEARCH. BOY THE END OF THE MEETING, THE RECOMMENDATIONS WERE VERY CLOSE TO FINAL. AND WE HAD SOME SIGNIFICANT DISAGREEMENT ABOUT LANGUAGE SUGGESTING THAT A TRANSPLANT SURGEON, PROVIDING CARE, COULDN'T OVERRULE AN INDIVIDUAL'S EXPLICIT DECISION NOT TO RECEIVE AN [ INAUDIBLE ] THAT DEBATE HAS CONTINUED IN THE 3-4 MONTHS SINCE THAT TIME ON THE SUBCOMMITTEES. AND THE RESULT HAS BEEN -- YOU THINK IT'S A BIT OF A COMPROMISE AND I'LL WALK THROUGH THE LANGUAGE. IT WAS REALLY FELT THAT THERE WAS -- THAT NOT TO GIVE PEOPLE THE ABILITY TO SAY NO WAS A VIOLATION OF THEIR AUTONOMY. IF YOU WERE GOING TO ASK AND THEN SAY, BUT IF THEIR DOCTOR DISAGREES, THEY CAN OVERRULE THEM, THAT IT TOOK AWAY SOME OF THE MEANING OR A LOT OF THE MEANING FROM THE DECISION. WE'LL GET TO DISCUSS THIS FURTHER AS WE GET INTO THE DOCUMENT. WHAT WE DID, REALLY, WHILE THAT WAS LEFT AS AN IMPLICATION, THE DECISIONS WERE BINDING. IT WAS NOT SHARED IN SUCH AN EXPLICIT WAY AND WE REALLY BEEFED UP THE RECOMMENDATIONS FOR ONGOING EDUCATION AND THE ABILITY TO REVISIT DECISIONS, PARTICULARLY IF THEY FELT THEY WERE NOT IN THE INDIVIDUAL'S BEST INTEREST. I THINK THIS ISSUE IS FURTHER COMPLICATED BY THE PRACTICAL MATTER THAT OFFERING A PARTICIPANT -- A POTENTIAL PARTICIPANT -- AN ORGAN, MANIPULATED ORGAN, WHEN THEY STATED THEIR INTENT TO REFUSE IT, COMPROMISES THE VEIL ABILITY TO SOMEONE ELSE. THAT'S ANOTHER DIMENSION TO THIS THAT IS A LITTLE BIT OUTSIDE OF WHAT WE USUALLY DO. SO THAT IS THE FIRST SET OF CHANGES, WHICH I'LL GO THROUGH. THE TRANSPLANT SURGEON, COURTHOUSE NEHMAN, ALSO EXPRESSED CONCERN -- CLAUS -- INSTITUTIONAL RISK AVERSION AND IF CONSENT WAS REQUIRED. HIS CONCERN WAS THAT INSTITUTIONS WOULD NOT WANT TO ENGAGE IN THIS AS A MATTER OF INSTITUTIONAL EXPOSURE AND WOULD FIND WAYS NOT TO DO THAT. THERE IS NO PERFECT ANSWER TO THAT, EXCEPT TO CREATE A CULTURE AND THE COMMUNITY WHERE THIS IS THE EXPECTATION. SO WE CAN DISCUSS THAT MORE IF IT COMES UP AGAIN. AND THEN THE MOST RECENT CHANGES WERE IN RESPONSE TO REQUESTS FOR CLARITY FROM HRSA. THEY WANTED TO KNOW EXACTLY WHAT WAS EXPECTED IN TERMS OF THE CONSENT AND WHAT THE TRANSPLANT TEAM WOULD BE INVOLVED IN. AND THEN OHRP ASKED FOR SOME CLARIFICATIONS ABOUT THE DISCUSSION OF WAIVERED CONSENT, SO I'LL GO OVER THOSE. TURNING TO THE DOCUMENT ITSELF, MOST OF THIS IS UNCHANGED SINCE MARCH AND SO I'M NOT GOING TO LINGER. THE OPENING IS LARGELY THE BACKGROUND AND RECAPITULATES THE NATIONAL ACADEMY'S REPORT, WHICH WAS OUR STARTING POINT, AND IF YOU RECALL WHAT THEY CAME DOWN WITH WAS A TWO-PART PROCESS WHERE PEOPLE WOULD BE EDUCATED TO THE POSSIBILITY OF MANIPULATED ORGANS AND RECALL THESE ARE ORGANS THAT ARE MANIPULATED BY THEIR AFTER-HARVEST OR AFTER-COLLECTION OR WHILE STILL IN THE DONOR BUT WHEN THAT INDIVIDUAL IS LEGALLY AND CLINICALLY DECEASED. SO THE INTERVENTION ITSELF IS NOT AN INTERVENTION. THAT INTERVENTION IS NOT RESEARCH ON A HUMAN SUBJECT PER THE REGULATIONS. THERE ARE OTHER ISSUES ABOUT GETTING CONSENT FOR THIS FROM THE FAMILY AND SUCH. THOSE ARE NOT WITHIN THE SCOPE OF THE DOCUMENT. AND THEN WHERE THE NATIONAL ACADEMIES CAME DOWN AND -- THIS IS THE CONCLUSION WITH WHICH WE AGREED -- IS THAT RECIPIENTS OF ORGANS WHO WERE MANIPULATED AND RECEIVING THOSE IN AN ATTEMPT TO IMPROVE THE TRANSPLANT PROCESS, AND THEIR OUTCOMES ARE BEING STUDIED, ARE RESEARCH CENTERS. THEY ARE RECEIVING A MANIPULATED ORGAN. SO THAT'S REALLY THE BACKGROUND THAT GOES OVER THAT WHOLE PROCESS. FOR THOSE OFF -- I KNOW WE HAVE NEW MEMBERS -- FOR THOSE WHO HAVE NOT BEEN ENGAGED BEFORE, IF YOU HAVEN'T DEALT WITH ORGAN TRANSPLANTS -- AND I HAVE TO SAY THIS HAS BEEN A LEARNING EXPERIENCE FOR ME -- WHEN INDIVIDUALS HAVE DISEASE THAT IS SERIOUS ENOUGH TO CONTEMPLATE AN ORGAN TRANSPLANT, THEY ARE TOLD ABOUT THAT AND PUT ON A WAITING LIST AND THEN THERE IS -- WHEN AN ORGAN BECOMES AVAILABLE THAT IS APPROPRIATE FOR THEM, THEY HAVE A VERY SHORT TIME TO DECIDE WHETHER OR NOT TO ACCEPT THAT ORGAN AND THEY MAKE THAT DECISION QUICKLY AND THEN BASICALLY GO INTO SURGERY. AND THEN TIME CONSTRAINT IS ANYWHERE FROM AN HOUR TO HALF HOUR FOR NOT ONLY THE INDIVIDUAL TO DECIDE TO ACCEPT BUT ALSO FOR THE TRANSPLANT TEAM TO MOBILIZE, FOR THE TRANSPLANT SURGEON TO AGREE IT'S AN APPROPRIATE ORGAN FOR THAT INDIVIDUAL. SO IT'S A VERY COMPRESSED TIME. >> STEPHEN? >> JULIA? >> I'M SO SORRY TO INTERRUPT YOU. I DID JUST WANT TO POINT OUT THAT WE DO HAVE SEVERAL REPRESENTATIVES FROM HRSA ON FOR THIS DISCUSSION, AND I WANTED TO MAKE SURE THEY JUST FEEL WELCOME TO JOIN IN AND ASK QUESTIONS. I ALSO WANTED TO POINT OUT THAT AT LEAST FOR ME, YOU'RE VERY QUIET. SO IF IT'S AUDIO IN GENERAL OR MAYBE YOU COULD SPEAK UP A LITTLE MORE. THANK YOU. >> DR. ROSENFELD: ALL RIGHT. LET ME TWEAK MY AUDIO FIRST. IS THIS BETTER? I HAVE MULTIPLE MICROPHONES I CAN USE. IS THIS STRONGER? >> I'M HEARING IT AT ABOUT THE SAME. >> DR. ROSENFELD: OKAY, I'LL TRY TO SPEAK LOUDER. >> OKAY, THAT'S BETTER, DEFINITELY. >> DR. ROSENFELD: SO HERE YOU'LL SEE THIS CHANGED LANGUAGE. WE HAD USED THE LANGUAGE, EXPANDED CRITERIA ORGANS, WHICH IS AN OLD NOMENCLATURE AND WE ARE TOLD NOW THEY ARE DESCRIBED AS NON STANDARD OR MARGINAL. SO THAT WAS CHANGED. I THINK THERE WAS ONE I MISSED BUT THE INTENT WAS TO CHANGE THAT THROUGHOUT. THE CONTEXT OF THAT IS THAT WHEN A PERSON IS PUT ON THE WAIT LIST FOR AN ORGAN, THERE ARE DIFFERENT TYPES OF ORGANS. THERE ARE YOUR STANDARD ORGANS COLLECTED BY STANDARD PROCEDURES AND HAVE ASSOCIATED FACTORS WITH THEM THAT MAKE THEM PREDICTABLE RISK, AND THEN THERE ARE THESE OTHER NON STANDARD OR MARGINAL ORGANS, WHICH REALLY TYPICALLY HAVE TO DO WITH DONOR DIFFICULTICS. AND PEOPLE ARE TOLD ABOUT THIS -- CHARACTERISTICS -- AND IN SOME CASES ASKED IF THEY ARE WILLING TO ACCEPT AN ORGAN UNDER THOSE CIRCUMSTANCES. SOME OF THE EXAMPLES HAVE BEEN THINGS LIKE HEPATITIS C WHERE IT WAS A TREATABLE DISEASE BUT THE ORGAN RECIPIENT RECENTLY TREATABLE, WOULD HAVE TO LOOK FORWARD TO BEING TREATED AFTER THEY RECEIVED THE ORGAN. SO THIS GOES THROUGH THE MECHANICS AND THEN AT LINE 48, WE TALK ABOUT THE REASONS FOR SACHRP'S INVOLVEMENT AND THAT'S THE LACK OF PROFESSIONAL CONSENSUS IN THE COMMUNITY, A LACK OF STANDARDIZED PRACTICE. SO, THE OTHER PIECE THAT IS WITHIN THE DOCUMENT IN WHICH WE LEARNED FROM THE REPORTS AND THE MULTIPLE PANELS WE HAD IS THAT THE PRACTICAL -- PRACTICALITIES OF ORGAN TRANSPLANTATION VERY GREATLY, DEPENDING ON THE CENTER WHERE THAT TRANSPLANT IS OCCURRING. AND THAT IS REALLY A UNIQUE VENUE IF YOU'RE TRYING TO DO RESEARCH ACROSS ALL OF THOSE ENT ENTITIES. SO ONE OF THE PLACES WE CAME DOWN WAS, WE WANTED TO DEFINE WHAT IT IS THAT MAKES THIS A DIFFICULT PROBLEM Y SHOULD THIS NOT BE SUBJECT TO THE EXISTING REGULATIONS. WHY WERE THERE PROBLEMS WITH THE EXISTING REGULATION? I'LL JUST GO THROUGH THESE BRIEFLY TO REITERATE. SO THERE ARE TWO INTERVENTIONS AS WE HAVE ALREADY DISCUSSED. THE INTERVENTION OF THE DECEASED DONOR AND THEN THE INTERVENTION THAT IS CONSTITUTED BY THE TRANSPLANT, WHICH IS A TRANSPLANT OF A MANIPULATED ORGAN IN ORDER TO DETERMINE WHETHER THAT MANIPULATION IMPROVES OUTCOMES. THE LACK OF WELL-DEFINED SITES, SO OVER 250 HOSPITALS IN THE U.S. THAT DO TRANSPLANTS. I THINK THE VISION FOR DDIR IS THAT THERE MAY BE ONE CENTER THAT -- AND JIMBO MAN AND OTHERS FROM HRSA CAN CORRECT ME. MY SENSE IS WE ARE MOVING MORE AND MORE TOWARDS A NATIONAL TRANSPLANT APPARATUS FROM ONE THAT WAS MORE LOCAL. AND THE IDEA, THE VISION FOR THIS KIND OF RESEARCH IS THERE WOULD BE ORGANS. THE RECIPIENTS WOULD COME OFF THE WAIT LIST AND THAT COULD HAPPEN ANYWHERE IN THE COUNTRY. SO NO WAY TO PREDICT WHERE A POTENTIAL RECIPIENT IS GOING TO BE BEFORE THAT HOUR TO HALF HOUR CALL WHERE YOU HAVE TO MAKE YOUR DECISION. SO THAT WAS REALLY KIND OF A UNIQUE -- IF THERE ARE 10 PROTOCOLS FOR THIS, AND THERE ARE 250 SITES, AND MOST OF THEM NEVER KNOW WHETHER THEY ARE GING TO EVER SEE AN ORGAN INVOLVED IN THAT PROTOCOL. TO BRING EVERYBODY UP TO SPEED ON ALL POSSIBLE PROTOCOLS AS A TYPICAL RESEARCH SITE AS WE USUALLY UNDERSTAND IT, REALLY DOESN'T FIT THE CURRENT MODELS. WHAT WE SPENT THE MOST TIME ON IS THE CONSTRAINT THAT WE TALK ABOUT AT LINE 79, BECAUSE IT REALLY IMPACTS THE COMMON RULE AND THE REQUIREMENTS FOR CONSENT. THERE IS REALLY VERY, VERY LITTLE TIME TO MAKE THIS DECISION ON THE PART OF THE RECIPIENT AND WE'LL GET INTO THAT LATER. SO ONE OF THE THINGS THAT WAS BROUGHT UP EARLY ON IS THAT IRBs AND RESEARCHERS OFTEN DEAL WITH EMERGENT CLINICAL SITUATIONS WHERE THERE IS VERY LITTLE TIME. CARDIAC ARREST, STROKE, ALL SORTS OF THINGS. ONE OF THE STRUCTURAL DIFFERENCES HERE IS THAT YOU CAN'T JUST SAY WE DON'T KNOW WHO IS GOING TO BE OFFERED RESEARCH UNDER THIS PROTOCOL BECAUSE WE DO HAVE A GOOD IDEA OF THE UNIVERSE. THEY ARE VERY WELL DEFINED GROUP OF PEOPLE, THE PEOPLE ON THE TRANSPLANT WAITING LIST. SO STRUCTURAL DIFFERENCES THAT WE FELT HAD ETHICAL IMPLICATIONS IMPLICATIONS. THE CHOICE FACING THE POTENTIAL PARTIIPANT IS UNUSUALLY STARK SO THERE IS DATA TO TOGETHER YOU REFUSE AN OFFER OF AN ORGAN, YOUR RISK OF DEATH IS SIGNIFICANTLY HIGHER IF YOU WAIT. SO IF YOU WAIT FOR THE NEXT ONE. SO, YOU'RE REALLY FACING THE DECISION OF WHETHER TO ACCEPT A LIFE-SAVING INTERVENTION THAT WILL HAVE VERY LIKELY AN IMPACT ON YOUR MORTALITY BUT IF YOU -- BUT THAT DECISION MEANS YOU'RE PARTICIPATING IN RESEARCH. SO BASICALLY, YOU'RE DIRECTLY CONNECTING IN ALMOST ALL CASES OF THIS KIND OF RESEARCH, SURVIVAL TO RESEARCH PRTICIPATION, WHICH I THINK IS A DIFFICULT DECISION TO ASK PEOPLE TO MAKE. THAT'S CAPTURED IN LINES 97-102. 102 RAISES ANOTHER ISSUE. SO ONE OF THE COMPLEXITIES HERE AND ONE OF THE REASONS FOR DOING THIS KIND OF RESEARCH IN THE FIRST PLACE IS THAT THERE IS A SHORTAGE OF ORGANS. THE WHOLE PURPOSE OF THIS KIND OF RESEARCH IS TO RUN THE POOL OF AVAILABLE ORGANS SO MORE PEOPLE ON THE WAITING LIST CAN RECEIVE AN ORGAN. IF WE GET TO A POINT WHERE THIS KIND OF RESEARCH IS MORE COMMONPLACE, IT'S POSSIBLE IT WILL HAVE AN IMPACT ON THE FULL POOL OF ORGANS THAT ARE AVAILABLE. SO, THE DECISION TO ALLOW A DDIR PROTOCOL HAS TO BE REVIEWED IN THE CONTEXT OF THE ORGAN DELIVERY SYSTEM AND RESEARCH AS A WHOLE. IT CAN'T BE -- NOTHING CAN BE REALLY A ONE OFF. SO WE RESPONDED -- THE WAY THE REST OF THE DOCUMENT IS STRUCTURED, WE RECEIVED EXPLICIT QUESTIONS FROM OHRP TO WHICH WE RESPONDED AND THEN COME UP WITH RECOMMENDATIONS AT THE END. SO I'M GOING WALK THROUGH THESE BECAUSE IT'S BEEN A WHILE AND I'LL HIGHLIGHT THE THINGS THAT HAVE BEEN CHANGED. SO THE FIRST QUESTION WAS, IF THE TWO-PART PROCESS PROPOSED BY THE NATIONAL ACADEMIES ARE SEEKING INFORMED CONSENT -- AND YOU RECALL THAT WAS GIVING PEOPLE GENERAL INFORMATION WHEN THEY ARE PUT ON THE WAITING LIST AND THEN FILLING IN THE SPECIFICS ABOUT THE PROTOCOL AT THE TIME OF ORGAN OFFER -- WOULD THE INFORMATION PROVIDED TO A CANDIDATE IN THE SECOND PART OF SUCH A PROCESS, AT THE TIME OF ORGAN OFFER, BE VERY DIFFERENT FROM THE INFORMATION THEY NOW GET AS PART OF THE CLINICAL CONSENTING PROCESS? AND DOES IT CHANGE IF THE ORGANS ARE COMING FROM -- SO WE TALK ABOUT THIS BUT I THINK THE BOTTOM LINE THAT WAS WE FELT, YES, IT WOULD BE DIFFERENT. AND WHILE THERE ARE A LOT OF SPECIFICS ABOUT WHY IT WOULD BE DIFFERENT, PART OF IT IS THAT WE HAVE DIFFERENT EXPECTATIONS FOR RESEARCH CONSENTS HANDY FOR CLINICAL CONSENTS. AND IF YOU HAVE TO GO THROUGH THE REQUIRED ELEMENTS OF 116B, AS WE'LL DISCUSS LATER, THERE IS NO QUESTION THAT THAT WOULD TAKE LONGER THAN THE CLINICAL CONSENT WHERE PEOPLE, WHICH ARE REALLY JUST FROM A PAPER POINT OF VIEW, IS MUCH SHORTER AND WHERE PEOPLE ARE MUCH MORE USED TO RELYING ON THE ASSESSMENT OF THEIR TREATING CLINICIAN. SO THE CONCLUSION WAS WHILE CLINICAL CONSENT IS FROM A HIGH-RISK DONOR PROVIDES MANY PARALLELS BECAUSE IN THOSE SETTINGS, THERE IS ADDITIONAL INFORMATION THAT HAS TO BE CONVEYED, THE DIFFERENCE BETWEEN WHAT IS ADEQUATE FOR CLINICAL AS COMPARED TO RESEARCH, LED SACHRP TO CONCLUDE THAT RESEARCH CONSENT WOULD BE EXPECTED TO REQUIRE MORE TIME IN DISCUSSION THAN HAS USUALLY BEEN ALLOTTED FOR CLINICAL CONSENT. AND I THINK THAT IS FAIRLY NON CONTROVERSIAL. QUESTION TWO. SHOULD IRB APPROVAL OF A PROTOCOL BE AFFECTED BY SPECIFIC ORGAN TRANSPLANTATION, INCLUDING WHAT I TALKED ABOUT, THE VERY SHORT TIMEFRAME IN WHICH ONE HAS TO ACCEPT OR REJECT. WHAT THE RISK OF DEATH OR DISABILITY IS WITHOUT THE TRANSPLANT AND WHAT THE LIKELIHOOD IS OF THEM GETTING ANOTHER OFFER IF THEY SAY NO. AND NUMBER 4, THE FACT THAT ANY ORGAN OFFERED FOR TRANSPLANTATION, SUBJECT RESEARCH INTERVENTION OR NOT, MUST BE INDIVIDUALLY ACCEPTED BY A TRANSPLANT CANDIDATE. I'M NOT SURE WE REALLY EVER UNDERSTOOD WHAT THE POINT OF THAT WAS, BECAUSE THAT'S JUST A GIVEN. SO WE REALLY FELT THAT ALL OF THESE THINGS HAD IMPLICATIONS. THE TIME PERIOD AVAILABLE TO TRANSPLANTATION, LESS IMPLICATIONS ABOUT THE EQUIVALENT OF THE PROTOCOL BUT AS REAL IMPLICATIONS FOR THE PROCESS OF CONSENT. AND HENCE [ INAUDIBLE ] WHETHER A TRANSPLANT CANDIDATE IS LIKELY TO DIE -- WE DIDN'T FEEL THIS REALLY CHANGED THINGS BECAUSE THAT'S TRUE OF MANY DIFFERENT KINDS OF RESEARCH AND THE RISK OF DEATH IS SOMETHING THAT WE ROUTINELY TAKE INTO ACCOUNT. AGAIN, THIS MAY BE -- BASICALLY NOT SO DIFFERENT THAN WHAT WE USUALLY SEE. THE LIKELIHOOD THEY WILL RECEIVE OTHER ORGAN OFFERS, AGAIN THESE THINGS IMPACT ONE'S ABILITY TO GET TRULY INFORMED CONSENT THAT IS NOT UNDULY INFLUENTIAL. AND WE MAKE THE POINT LATER IN THE DOCUMENT WHEN WE USUALLY USE THOSE TERMS, THEY ARE USED CRITICALLY ABOUT THE CONSENT PROCESS OR THE DOCUMENT. IN THIS SETTING, I THINK YOU COULD ARGUE THAT THE SITUATION IS UNAVOIDABLY UNDULY AND -- [ LOW AUDIO ] THOSE THINGS HAD TO BE CONSIDERED. NUMBER 4 IS WHAT I RAISED EARLIER. IT'S NOT CLEAR -- QUESTION 3 HOW PRACTICAL WOULD IT BE -- [ LOW AUDIO ] IN PARTICULAR THE SECOND STEP, GETTING -- [ LOW AUDIO ] I THINK WE EMPHASIZED EARLY ON THERE ARE NO LIMITATIONS. THERE MAY BE CERTAIN CIRCUMSTANCES WHERE SOMEONE IS SO SERIOUSLY ILL THAT THEY ARE HOSPITALIZED AND PUT ON THE LIST AND RECEIVED A TRANSPLANT WITHIN DAYS AND I BELIEVE ONE OF THE PEOPLE WHO SPOKE TO US ON THE PANEL IN MARCH -- [ LOW AUDIO ] IN GENERAL, THAT'S NOT THE WAY IT WORKS. YOU STAY ON THE LIST -- [ LOW AUDIO ] I THINK THE GENERAL STRATEGY IS TO PUT AS MUCH WEIGHT AS WE COULD ON STEP 1. SO MULTIPLE INTERACTIONS, LOTS OF TIME, LOTS OF TIME TO EXPLAIN EXPLAIN, REEXPLAIN, AND THIS IS WHERE WE GOT INTO TROUBLE AT THE LAST MEETING. THIS IS WHERE WE STARTED TO FIX WHAT GOT US IN TROUBLE. WE STARTED TO PUT IN LANGUAGE HERE 236-238, THAT IT WAS REALLY BEHOLDEN ON THE TRANSPLANTEE TO CONTINUE TO RAISE THIS ISSUE, PARTICULARLY IF SOMEONE SAYS, NO,. IT'S THE CLINICAL TEAM FEELS IT'S NOT IN THE PERSON'S BEST INTEREST, THEN THEY REALLY -- THE PERSON'S DECISION MUST STAND BUT THERE IS NOTHING TO PRECLUDE IT BEING RAISED AND ADDITIONAL INFORMATION BEING PROVIDED. SO THEN WE TALK ABOUT STEP 2 OF THE CONSENT, AND THAT'S REALLY THE PROBLEM. IF YOU HAD THE TYPICAL TIME UNDER A NORMAL -- AND YOU OFTEN DO. IT'S REALLY DIFFICULT TO CONVINCE ONES SELF THAT PEOPLE HAVE TIME FOR SUBSTANTIVE DISCUSSION, OR AS THE REGULATIONS REQUIRE, THE OPPORTUNITY TO DISCUSS AND CONSIDER PARTICIPATION. THERE JUST ISN'T TIME. AND IT'S NECESSARY BECAUSE IT'S A FUNCTION OF THE VIABILITY OF THE ORGAN AND THE NECESSITIED IF SOMEONE SAYS NO TO BE ABLE TO OFFER IT TO THE NEXT PERSON ON THE LIST. SO THAT'S NOT GOING TO CHANGE. AND THAT'S REALLY WHERE THE -- SO WE DISCUSSED THIS. WHEN WE CONCLUDE THAT DETERMINING STEP TWO OF THE TWO-STEP PROCESS, CONFORMS WITH THE USUAL INTERPRETATION OF THE REGULATORY REQUIREMENTS. AND QUESTION 4 MAKES IT EXPLICIT. WITH THE TWO STEP PROCESS TAKEN AS A WHOLE SATISFIES REGULATORY CRITERIA FOR INFORMED CONSENT. WHAT THIS IS ASKING, WE CAN'T DO IT AT THE TIME OF THE RESEARCH DECISION. CAN WE OFF LOAD ENOUGH TO STEP 1 SO THAT WE CAN CONSIDER THIS AND EFFECTIVE CONSENT FOR STANDARD INTERPRETATION. AND WE DID NOT FEEL THAT THIS WAS LIKELY TO BE TRUE. THERE IS LOTS OF PIECES TO THIS. PART OF IT IS THAT THESE -- PEOPLE CAN BE ON THE TRANSPLANT LIST FOR YEARS SO IT'S PROBABLY LIKELY THAT THE PARTICULAR RESEARCH PROTOCOL UNDER WHICH THEY ARE OFFERED THEIR ORGAN EVENTUALLY, WASN'T EVEN WRITTEN AT THE TIME OF THE INITIAL CONSENT PROCESS. SO WE HAVE TRADITIONALLY REQUIRED SPECIFICITY, PARTICULARLY FOR INTERVENTIONAL RESEARCH ABOUT WHAT IS GOING TO HAPPEN, AND IT SIMPLY IS NOT POSSIBLE TO GIVE THAT UNTIL THE STEP 2 PROCESS. SO IF YOU PLACE THOSE REQUIREMENTS ON STEP 2, THEN THERE SIMPLY ISN'T ENOUGH TIME TO DO IT TO OUR USUAL STANDARDS. >> THE FUNDAMENTAL PROBLEM. AND A LOT OF THESE -- THE ARGUMENTS AND A LOT OF THESE QUESTIONS ARE DUPLICATIVE. I APOLOGIZE IF I SOUND LIKE I'M REPEATING THE SAME QUESTION OVER AND OVER AGAIN. SO, QUESTION 5 STARTS TO TALK ABOUT WAIVERS OF CONSENT. SO PART OF THE HISTORY OF THIS PROBLEM IS THAT THE PROTOCOL THAT BROUGHT ATTENTION TO THIS WAS CONDUCTED UNDER A WAIVER AND THE IRB -- WE HAVE CHOSEN NOT TO TALK ABOUT THE CRITERIA FOR MINIMAL RISK AS PART OF THE DISCUSSION OF THOSE DOCUMENTS AND THAT WAS INTENTIONAL DIRECTION BECAUSE IT'S VERY PROMULGATED. I THINK THERE ARE MISUNDERSTANDINGS AND EVEN IF YOU COULD ARTIS LAKE, A CLEAR APPLICATION OF MINIMAL RISK -- ARTICULATE -- THERE WILL BE SOME PROTOCOLS THAT ARE MORE RISK AND THEY ARE GOING TO BE SOME THAT ARE NOT. SO YOU STILL HAVE TO ANSWER THE QUESTIONS. SO WE BASICALLY CHOSE NOT TO GET INTO THE RISK DISCUSSION. THE QUESTION IS SHOULD THE WAIVER OF CONSENT BE AFFECTED BY CIRCUMSTANCES SPECIFIC TO ORGAN TRANSPLANTATION. WE GO OVER THE MINIMAL RISK DEFINITION AND THE FACT THAT IT IS REFERENCED IN THE QUESTION ARE THE ONES THAT CAME UP BEFORE. LIKELIHOOD OF DEATH WITHOUT ACCEPTANCE AND THE POSSIBILITY OF ANOTHER ORGAN OFFER. AND THE APPLICATION FOR WAIVER OF CONSENT SHOULD APPLY HERE IN THE SAME WAY THEY APPLY TO ANY OTHER RESEARCH. NOTHING DIFFERENT ABOUT THE APPLICATION OF THE CRITERIA. SO QUESTIONS 6 STARTS TO GET INTO INDIVIDUAL CRITERIA. [ READING ] I THINK THE ANSWER IS A BIT OF A -- THIS IS A DIFFICULT QUESTION. AND THERE IS NOTHING DIFFERENT IN THIS SETTING IN TERMS OF PROTECTING RIGHTS OF WELFARE. AND IRBs DO THIS ALL THE TIME. PART OF OUR CONCERN HERE IS THAT I THINK IRBs DO THIS -- DON'T ALWAYS DO THIS CONSISTENTLY. THAT'S A DIFFERENT PROBLEM AND WE DIDN'T WANT TO CONFOUND THIS ALREADY COMPLICATED ISSUE WITH THAT. SO THIS IS, QUESTION 7 GOES INTO THE PRACTABILITY. IF IT'S NOT PRACTICAL, CONSENT FOR A STUDY -- IS IT PERMISSIBLE PERMISSIBLE -- SO FIRST OF ALL, THE OTHER CRITERIA ARE SATISFIED AND NOT APPLICABLE. AND IT WOULD BE APPROPRIATE THE LAST RECOMMENDATION. SO THE LAST RECOMMENDATION SAID THAT OFTEN WHEN AN IRB USES -- [ LOW AUDIO ] IT IS A SIGNAL IF THEY ARE HAVING THAT DISCUSSION IT'S NOT GOING TO SATISFY THE REQUIREMENT REQUIREMENT. SO WHEN WE TALK, YOU'LL SEE -- IF YOU HAVEN'T READ THE DOCUMENT, WHAT WE COME DOWN TO IS RECOMMEND THIS RESEARCH BE DONE UNDER -- BECAUSE IT'S IMPACTABLE TO GET CONSENT UNDER ANY CIRCUMSTANCES AS WE TRADITIONALLY UNDERSTAND IT. IF IT'S IN PRACTICABLE AND THAT JUSTIFIES THE WAIVER WHERE CONSENT MIGHT BE REQUIRED, IT DOESN'T MAKE SENSE TO SAY YOU COULDN'T USE IT, BUT IT'S NOT IMPACTIBLE ENOUGH OR WITH MINIMAL RISK. SO IN THE END, FOR ALL THE THINGS WE SAY IN THE REST OF THE DOCUMENT, THE SENSE WAS -- I WOULDN'T SAY THE SENSE WAS. THIS WAS A CHANGE MADE BY ME AFTER THE SUBCOMMITTEE IN RESPONSE TO QUESTIONS. WE SHOULD TALK ABOUT THIS IF PEOPLE -- IT SEEMS LIKE THE REST OF THE DOCUMENT GOES TO SUCH GREAT LENGTHS TO DEMONSTRATE IMPACTABILITY THAT TO SAY HERE, IN THE CASE OF MINIMAL RISK, IT IS SOMEHOW PRACTICABLE, DOESN'T MAKE LOGICAL SENSE AND I THINK WHAT THIS COMES DOWN TO IS THE OTHER CRITERIA WERE SATISFIED, IMPACTABILITY WOULDN'T BE THE CRY TEARSIA -- QUESTION 8. IS A SECT AIRLINE WAIVER NECESSARY? [ LOW AUDIO ] WE WENT BACK-AND-FORTH WITH THIS. THE COMMITTEE AND THE SUBCOMMITTEES SWUNG 180 DEGREES A COUPLE OF TIMES. I THINK WE WERE ALL IMPRESSED FOR THE LAST YEAR AND A HALF ABOUT THE URGENCY AND THE IMPORTANCE OF THIS RESEARCH AND WE REALLY HAVE BEEN FOCUSED ON TRYING TO FIND THE SIMPLEST PATH FORWARD TO LET IT GO FORWARD ETHICALLY. AND I THINK THAT IS WHAT HAS BEEN DRIVING US AND HAS DRIVEN THE CHANGES IN APPROACH. BUT WHERE WE FINALLY CAME DOWN IS THAT WE FELT IT WAS JUST TOO MUCH OF A STRETCH TO SUGGEST THAT YOU COULD SATISFY ALL OF THE CONSENT REGULATIONS IN THE HOUR OR HALF HOUR YOU HAVE. AND THIS IS INCREASINGLY DESCRIBED AS ALL IN THE MIDDLE OF THE NIGHT. YOU DON'T KNOW. IT'S A TRANSPLANT COORDINATOR, TYPICALLY MAKING THE CALL. THAT HOUR OR HALF HOUR, THEY ONLY GET TO THE PARTICIPANT AFTER ITS RUN BY THE SURGEON AND THEY HAVE CONFIRMED WITH THE FACILITY THE TRANSPLANT IS AVAILABLE. THIS IS A VERY SPORT PERIOD OF TIME IN WHICH ONE HAS TO COMMIT -- SHORT -- YOU CAN'T MAKE THE TIME LONGER BECAUSE THAT BECOMES AN ISSUE OF SCARCE RESOURCES AND IF IT'S NOT GOING TO WORK FOR THAT INDIVIDUAL, IT NEEDS TO BE PASSED TO THE NEXT PERSON ON THE LIST. WE FELT UNDER THOSE CONSTRAINTS, THAT IT MAY NOT BE POSSIBLE TO SATISFY THE REGULATORY CRITERIA TO CONVEY KEY INFORMATION AND CONSENT IN A WAY THAT FACILITATES UNDERSTANDING. THAT'S THE LANGUAGE IN THE REGULATION. AND PARTICIPANTS HAVE SUFFICIENT OPPORTUNITY TO DISCUSS AND CONSIDER PARTICIPATION RESEARCH AND CIRCUMSTANCE THAT IS MINIMIZE THE POSSIBILITY OF COERCION OR -- IT'S JUST A MATTER OF TIME. WE CAN DISCUSS IT IF YOU LIKE. AND THIS IS THE CONCLUSION. SOME CASE WHERE IS IT'S KNOWN AND THEN MOST CASES YOU CAN'T COUNT ON THAT. SO YOU REALLY HAVE TO DO IT ALL IN STEP TWO. SO QUESTION NINE PIVOTS TO ANOTHER RECOMMENDATION FROM THE REPORT. AND THAT WAS THAT THIS TYPE OF RESEARCH BE CENTRALLY MANAGED. AND THEY SUGGEST THE IMPLEMENTATION OF THREE ORGANIZATIONS. A CENTRAL IRB DEDICATED AND I APOLOGIZE BUT I FORGOTTEN WHAT IT STANDS FOR. BUT IT'S DONOR RESEARCH. >> OVERSIGHT COMMITTEE. >> THANK YOU. SO THAT IS ESSENTIALLY THE SCIENTIFIC REVIEW FUNCTION AND DSMB WOULD BE CONVERSANT WITH EVALUATING RISKS AND SAFETY IN THIS PARTICULAR CIRCUMSTANCE WE FELT THAT ALL OF THESE RECOMMENDATIONS WERE SOUND. GIVEN THE ISSUES ABOUT MINIMAL RISK AND OTHER PECOOLATORS, WE HAVE THE IDEA THAT -- AND SO THERE ARE TWO ISSUES. THE ISSUE OF CENTRAL IRB REVIEW AND THE ISSUE OF SING E8 IRB REVIEW. SO THE ISSUE OF CENTRAL IRB REVIEW IS A NO-BRAINER HERE BECAUSE OF WHAT I DISCUSSED ABOUT THE SITES. IF YOU HAD TO HAVE IRBs AT EACH 250 SITES REVIEW AND OPINE ON EACH PROTOCOL THAT CAME UP, THE SITES ARE CLINICAL AND LESS CONVERSANT WITH RESEARCH AND THEIR IRBs WOULD SEE THESE RARELY. WE FELT THAT'S WHERE WE SHOULD END UP. THE PECULIAR NATURE OF THIS RESEARCH, IT'S DIFFERENT. AND I THINK THERE IS VALUE IN HAVING AN IRB THAT IS REALLY FAMILIAR WITH THESE ISSUES. SO WE CAME OUT STRONGLY. THERE IS A PRACTICAL CONSEQUENCE TO THAT. SO THESE THINGS DON'T EXIST TODAY. THEY WILL F THEY ARE SET UP, IT WILL TAKE TIME AND EFFORT AND RESOURCES. AND SO THE QUESTION IS DO WE WANT TO MAKE ALL THE REST OF THIS. [ LOW AUDIO ] AND WE FELT THE URGENCY OF THE RESEARCH AND NEED FOR THIS PRECLUDED THAT CONCLUSION AND THAT IN FACT WE DON'T WANT TO DIMINISH THE STRENGTH OF OUR RECOMMENDATION TO THOSE ENTITIES. BUT WE DON'T WANT TO HOLD UP ALL THIS RESEARCH AND THAT IS THE ADDED LANGUAGE. WE WANTED TO MAKE IT CLEAR IF THE WAIVER AND EVERYTHING ELSE WE RECOMMEND ISN'T CONTINGENT ON THESE ENTITIES EXISTING. ON THE OTHER HAND, JUST BECAUSE YOU CAN GO AHEAD NOW, WE DON'T WANT TO DIMINISH THE STRENGTH AND THE REPUTATION. SO IT'S A LITTLE BIT -- SHOULD NOT BE INTERPRETED AS -- [ READING ] QUESTION 10 IS AN INTERESTING ONE THAT WE DIDN'T HAVE ENOUGH CHANCE TO DISCUSS. SO WHEN ORGAN MANIPULATION -- WHEN MANIPULATION OCCURS ON THE DONOR, THE TYPICAL ORGAN DONOR, AS I UNDERSTAND IT, IS A SOURCE OF MULTIPLE ORGAN -- SO IF YOU HAVE AN INTERVENTION THAT TARGETS THE VIABILITY OF THE HEART, IT'S ADMINISTRATION OF HYPOTHERMIA AND SYSTEMIC -- IT WILL EFFECT THE LIVER AND LUNGS AND THE KIDNEY. WHAT DO YOU DO? THOSE ARE NOT THE TARGETS OF THE RESEARCH. WHAT STATUS IS THE RECIPIENTS OF THE OFF TARGET -- WHAT STATUS IS THAT? AS AN INDIVIDUAL YOU WILL BE RECEIVING FROM THE PERSPECTIVE OF THE PARTICIPANT, IT LOOKS TO YOU AS IT WOULD IF YOU WERE -- WE FELT THESE INDIVIDUALS SHOULD HAVE THE SAME PROTECTIONS. IT MAY BE TRUE THE DOWNSTREAM RESEARCH IF THE TARGET ORGAN IS THE LIVER, YOU MAY BE SCHEDULED TO HAVE LIVER BIOPSIES THAT ARE NOT OTHERWISE CLINICALLY -- AND SO THERE WILL BE RESEARCH PROCEDURES, NOT JUST PROTOCOLS. -- IN OTHER WAYS THEY WOULD LOOK JUST LIKE PEOPLE -- [ LOW AUDIO ] I WOULD SAY ANOTHER ARGUMENT IN FAVOR OF THAT IS JUST WHAT WE STARTED WITH. AND THE ONLY WAY TO ENSURE A STANDARDIZED ACROSS-THE-BOARD -- [ LOW AUDIO ] WE DID FEEL THAT SECRETARIAL WAIVERS ARE REQUIRED. I TALKED ABOUT THAT BEFORE. ONE OF THE THINGS THAT CAME UP IN THE SUBCOMMITTEES IS WE DO RESEARCH IN THE URGENCY SETTING. NOT UNCOMMONLY THEY DON'T REQUIRE SECRETARIAL WAIVER. WE REALLY FELT THAT WE DID NOT WANT THIS PROCESS, THIS IS VERY WELL DEFINED AND VERY PARTICULAR TO NECESSARILY INHERIT THAT STRATEGY NOR DID WE WANT TO SAY IT WAS NECESSARILY RIGHT BUT WE DIDN'T FEEL IT WAS WITHIN SCOPE. THAT'S WHAT THIS FIRST LANGUAGE IS. SO THE FIRST RECOMMENDATION WAS CREATION OF CENTRALIZED OVERSIGHT. THE SECOND WAS THE REQUIREMENT OF THE SECRETARIAL WAIVER AND THEN THE SECRETARIAL WAIVER RECOMMENDATION HAD THREE SUBPARTS. THIS IS WHAT IS -- SO SECRETARIAL WAIVER -- [ READING ] THE REQUIREMENT FOR THE PRESENTATION HAVE GONE KEY INFORMATION IS NOT WAIVER AND THE FOLLOWING RECOMMENDATIONS MUST BE IMPLEMENTED AS A CONDITION. IT'S AWKWARD. WE WERE TRYING TO -- ANYWAY -- IT SAYS WHAT IT SAYS. THERE ARE CERTAIN THINGS AND BASICALLY PEOPLE HAVE TIME TO DISCUSS. SO A2 IS SUFFICIENT TIME FOR DISCUSSION AND CONSIDERATION. B ARE THE REQUIRED ELEMENTS. A5I IS THE INSIDE SUMMARY, WHICH IS NOT WAIVED. AND THEN THIS IS THE ADDITIONAL RECOMMENDATIONS SO WE BEEFED UP THIS LANGUAGE IN RESPONSE TO THE COMMITTEE'S CONCERN AT THE LAST MEETING. ABOUT THE FACT THAT IT REALLY WAS INCUMBENT TO SEIZE EVERY OPPORTUNITY TO EDUCATE PEOPLE AND GIVE THEM THE OPPORTUNITY TO MAKE A FULLY INFORMED DECISION ABOUT WHETHER THEY WANTED TO SEE -- [ LOW AUDIO ] WE SAY POTENTIAL RECIPIENTS REMAIN FREE TO EITHER ACCEPT OR REFUSE THE OFFER OF AN ORGAN. SO REMEMBER, THIS IS ANOTHER SUBTLY HERE YOU'RE MAKING THE DECISION WHETHER TO BE OFFERED THE OPPORTUNITY TO PARTICIPATE IN RESEARCH. AND WE WILL PROBABLY END UP DISCUSSING THIS. THIS IS TOUGH. YOU COULD ARGUE THAT IF THIS IS WHERE WE WERE LAST TIME. IF YOUR TRANSPLANT SURGEON THINKS THIS IS THE BEST OPTION FOR YOU BUT YOU SAID, I DON'T WANT TO RECEIVE AN OFFER, NO HARM IN OFFERING YOU BECAUSE YOU CAN STILL ALWAYS SAY NO. BUT THE BULK OF THE DOCUMENT TALKS ABOUT HOW YOU DON'T REALLY HAVE TO SAY NO. SO THIS IS COMPLICATED AND WE TRIED TO FIND A WAY TO RESPECT THE AUTONOMY OF THE DECISION AND ALSO TO REITERATE OVER AND OVER AGAIN THAT PEOPLE NEED TO BE TOTALLY EDUCATED AND INFORMED BEFORE THEY CAN REVISIT IT WHENEVER THEY WANT. RECOMMENDATION FOUR IS FOR STANDARDIZED EDUCATION AND SO 4 IS FOR THE TRANSPLANT RECIPIENTS AND 5 IS FOR THE TEAMS BECAUSE AGAIN, THE TRANSPLANT SURGEONS ARE NOT INVESTIGATORS IN THIS RESEARCH. THEY MAY NOT KNOW ABOUT IT EXCEPT IN A SUPERFICIAL WAY BEFORE THEY RECEIVE AN ORGAN OFFER FOR ONE OF THEIR PATIENTS THAT HAS BEEN TREATED SO WE FELT THERE NEEDED TO BE A FLOOR OF EDUCATION BOTH FOR TRANSPLANT RECIPIENTS AND FOR THE TRANSPLANT CLINICAL TEAMS AS TO WHAT ALL OF THIS ENTAILS. SO 6 SAYS BASICALLY THAT WHILE WE ARE WAIVING 116B AND 116A2 IN THE CONTEXT OF THE ORGAN OFFER, THAT DOES NOT MEAN THAT THE INVESTIGATOR IN THE RESEARCH TEAM CONSENT DOCUMENTS SERVE MANY PURPOSES. AND WE FELT IT WAS IT WAS IMPORTANT FOR INVESTIGATORS TO WALK THROUGH THOSE REQUIREMENTS AND SATISFY THEM AND IT WAS IMPORTANT FOR RECIPIENTS TO HAVE THAT INFORMATION AT SOME POINT. THIS IS ONE OF THE CLARIFICATIONS REQUESTED BY HRSA HRSA. WE WANT TO MAKE CLEAR IT DOESN'T HAVE TO HAPPEN BEFORE SURGERY. CONSENT TO SURGERY IS WHAT HAPPENS THE NIGHT BEFORE OR HOUR BEFORE, THAT'S STEP TWO. TO HAVE PEOPLE SAY I'M GOING TO ACCEPT THIS ORGAN AND BRING THEM IN AND GIVE THEM FULL CONSENT FORM AND HAVE THEM WALK THROUGH IT AND SAY NO IS NOT ACCEPTABLE. THAT ORGAN IS NOW NOT AVAILABLE FOR ANYONE ELSE. THAT WHOLE APPARATUS IS IN PLACE TO TRANSPLANT THE ORGAN. WE REQUESTED A SECRETARIAL WAIVER BECAUSE WE DIDN'T FEEL IT WAS PRACTICAL TO GIVE CONSENT. SO BASICALLY, WE WANT PARTICIPANTS TO REVIEW AND SIGN THE COMPLETED FORM. IT'S BASICALLY ATTESTING THEY RECEIVED THIS INFORMATION AND EXPLAINED IT. IT'S NOT A CONDITION FOR THEM TO UNDERGO SURGERY. AND IT CAN HAPPEN AFTER THE SURGERY. THAT'S WHAT THIS TRIES TO MAKE IT EXPLICIT. THE CONSENT, WHAT WE CALL THE CONSENT FORM, IS NOT SERVING AS THE CONSENT FOR TRANSPLANT AT THIS TIME. IT'S AN INFORMATION DOCUMENT. 7 IS TO REITERATE THAT MULTIPLE THINGS COME TOGETHER. THE KEY INFORMATION REQUIREMENT OF THE COMMON RULE FITS THERE PERFECT BECAUSE IT GIVES A BLUEPRINT FOR WHAT IT IS THAT PEOPLE -- [ LOW AUDIO ] SO THAT IS A CONDITION TO BE PREPARED AND HUGE FOR CONSENT IS A CONDITION OF THE WAIVER AND ACKNOWLEDGING THAT THE CONVERSATIONS -- ADDITIONAL RESOURCES TO PLUG THE HOLES. ONE IS A WEBSITE THAT IS OBVIOUSLY DESIGNED WITH ACCESSIBILITY AND ALLOW PEOPLE A SYNOPSIS -- [ LOW AUDIO ] ONE OF THE EARLY SUGGESTIONS IS THIS COULD STAND IN FOR -- [ BACKGROUND NOISE ] >> THE TELEPHONE HOTLINE IS AVAILABLE TO ANSWER SPECIFIC QUESTIONS OF THAT PROTOCOL. SO THE PERSON WHO MAKES THAT CALL, WHICH CAN OCCUR AT ANY TIME, IS LIKELY A MEMBER OF THE TRANSPLANT TIME OR COORDINATOR, NOT THE SURGEON, WHO IS BUSY TRYING TO GET THE FACILITY SET UP. THEY ARE SIMPLY NOT GOING TO KNOW TO SUGGEST THAT EVERY TRANSPLANT COORDINATOR BE TRAINED ON ALL THE PROTOCOLS THEY MIGHT EVER RECEIVE, IS NOT REALISTIC. BUT THERE IS A GROUP THAT KNOWS ABOUT THAT RESEARCH AND THAT'S THE RESEARCHERS AND THE TEAM AND WE FELT THEY SHOULD BE AVAILABLE JUST AS YOU'RE AVAILABLE ON CLINICAL CALL, TO ANSWER SPECIFIC QUESTIONS THAT MAY COME UP. THAT MAY NOT HAPPEN VERY OFTEN BUT WE FELT IT WAS APPROPRIATE TO HAVE IT AVAILABLE. AND THEN 9 WAS, WE TALKED ABOUT ADDITIONAL PROTECTIONS SIMILAR TO THOSE OFFERED BY THE EMERGENCY EXCEPTIONS OF INFORMED CONSENT, COMMUNITY CONSULTATION BE CONSIDERED AND ENCOURAGED OR REQUIRED BY THE SINGLE IRB. THIS WAS FELT TO BE NOT SOMETHING WE WANTED TO REQUIRE IN ALL CASES NECESSARILY BECAUSE IT IS GOING TO BE FACT SPECIFIC. IT SHOULD BE CONSIDERED. SO THE LAST -- NOT QUITE THE LAST. THE NEXT SECTION IS JUSTIFICATION FOR THE SECRETARIAL WAIVER. IF YOU RECALL FROM THE REGULATIONS, A SECRETARIAL WAIVER CAN ONLY BE USED IF THE CONDITIONS ARE CONSISTENT WITH THE PRINCIPLES AVAILABLE. SO THIS IS A DISCUSSION OF HOW THAT WOULD WORK. REGULATORY CONSENT OR THE PROVISIONS ADHERENCE TO THE REGULATORY PROVISIONS FOR CONSENT. WE MAKE THE ARGUMENT HERE THAT USING THE KEY INFORMATION OF CONSENT ALONE AND EXTENSIVE USE OF STEP 1 PART OF THE PROCESS DOES APPROPRIATELY RESPECT INDIVIDUALS. -- TRYING TO REMEMBER THE SPECIFIC. SO THERE IS AN ISSUE IN THAT THE SHARED RESOURCE PIECE, YOU HAVE TO ALSO PROTECT OTHERS WHO MAY POTENTIALLY -- JUST A LITTLE SQUISHY BUT WE TRIED TO ADDRESS IT HERE. I THINK THE -- IT'S REALLY HARD SO JUSTICE, THIS IS A LOT OF THIS IS -- THERE ARE JUSTICE QUESTIONS BEHIND THIS AND THEY GO TO DR. NEHMAN'S COMMENTS AND I THINK THE JUSTICE -- I INVITE YOU TO READ THIS. THE JUSTICE CONCERNS ARE REALLY ADDRESSED BY THE OVERSIGHT AND THE FACT THAT EVERYONE FOLLOWS THE SAME STANDARD. IF A RESEARCH COOLING DONORS OR COOLING ORGANS IS DETERMINED TO BE EFFECTIVE AND WIDENS THE AVAILABILITY OF ORGANS FOR EVERYBODY, 80% OF TRANSPLANT SITES CHOOSE NOT TO ENGAGE IN THE RESEARCH BECAUSE THEY ARE CONCERNED ABOUT INSTITUTIONAL EXPOSURE, THAT REALLY UNFAIRLY BURDENS THE REMAINING 20% OF RECIPIENTS WITH PROVIDING THE PROOF. THAT'S THE MOST GENERAL SENSE. THERE ARE OTHER ISSUES AND IT IS PROBABLY TRUE THAT THE 250 ORGAN TRANSPLANT CENTERS DON'T ALL SERVE THE SAME POPULATION SO THERE ARE ISSUES JUST AS THERE ARE -- ABOUT THE RESEARCH IN GENERAL AND APPLICABILITY. WE FELT THE EXPECTATION WILL BE CENTRALIZED MANAGEMENT. ADDRESSES THE MAIN JUSTICE ISSUE. FOR THOSE WHO ARE NOT FAMILIAR WITH THE CIRCUMSTANCES, THAT LED TO US TAKING ON THIS TOPIC. THE ISSUE WAS TO SUM IT UP QUICKLY, ONE INSTITUTION CHOSE TO DO THIS FOR A PARTICULAR PROTOCOL, THEIR IRB GRANTED A WAIVER OF INFORMED CONSENT FINDING THE RESEARCH WAS MINIMAL. OTHERS QUESTIONS THAT DETERMINATION AS TO -- AND SUGGESTED IT WAS NOT MINIMAL RISK AND THEY WERE DOING RESEARCH ON PEOPLE WITHOUT CONSENT AND THERE WERE CONSEQUENCES FOR THE INSTITUTION AND TO THE INVESTIGATORS TO EVEN HAVE THAT CONVERSATION. AND I THINK AT LEAST TALKING TO DR. NEHMAN, THAT CAUSED A LOT OF CONCERN ABOUT WHETHER WE WANT TO DO THIS AT ALL IN THE FUTURE. AND YET EVERYBODY BELIEVES THAT THIS KIND OF RESEARCH IS NECESSARY TO INCREASE THE AVAILABILITY OF OTHER ORGANS. MUCH OF THIS RESEARCH HAS THE POTENTIAL TO INVOLVE FDA REGULATORS. THAT PATHWAY IS NOT AVAILABLE. INSTEAD, THE FDA HAS THESE TWO BROAD CATEGORIES WITH CONSENT. LIKE EXISTING CATEGORIES. UNDER 5023 AND 5024. AND 5023 IS REALLY SORT OF THE CIRCUMSTANCES PROTOCOL, EVERYTHING IS FINE BUT FOR AN INDIVIDUAL -- AND 5024 IS FOR POPULATIONS WHERE YOU CAN ANTICIPATE. AND WE SPENT A LOT OF TIME IN EARLIER DRAFTS OF THE DOCUMENT TRYING TO FIT THIS RESEARCH INTO THE 2054 EXCEPTION. AND I THINK THAT WAS THE RIGHT DECISION [ INAUDIBLE ] WE RECOMMEND THE NDA GO BACK TO RULEMAKING FOR THIS SPECIFIC CIRCUMSTANCE AND THEN WE ALSO, KNOWING THE BURDEN THAT WOULD CAUSE, WE MAKE THE SUGGESTION THAT THE FDA CONSIDER -- [ INAUDIBLE ] SO ALL IN FAVOR? I DON'T SEE ANY HANDS GOING UP, WHICH IS GOOD BECAUSE I COULDN'T WATCH BUT I'LL OPEN THE FLOOR FOR COMMENTS. THIS IS A MERCURY AN EFFORT AND WE REALLY APPRECIATE EVERYTHING YOU HAVE DONE. SO A COUPLE OF COMMENTS. IN TERMS OF MINIMAL RISK VERSUS NON MINIMAL RISK, I WANT TO SORT OF CLARIFY BECAUSE I THINK I JUST WANT TO UNDERSTAND. MINIMAL RISK IS EASY, RIGHT? BUT IF YOU'RE GOING TO GIVE -- I THINK SANDY TALKED ABOUT INTRAVENOUS MAGNESIUM TO GIVE THE DONOR. AND THAT WOULD NOT BE CONSTITUTED AS MINIMAL RISK. THAT WOULD BE MORE THAN MINIMAL RISK. SO HOW -- COULD YOU GO OVER THIS AGAIN JUST FOR MY CLARIFICATION? >> SO, I DON'T KNOW THAT'S A GREAT EXAMPLE IT'S NOT THAT INTERVENTION OF THE DONOR -- SO I'M GOING STATE THIS AND YOU'LL HEAR MY BIAS BUT THAT'S ONE OF THE REASONS WHY WE DIDN'T -- SO THE PRESUMPTION IS, YOU'RE GIVING SOMEONE A MANIPULATED ORGAN BECAUSE YOU WANT TO KNOW WHETHER MANIPULATION OF THAT ORGAN HAS BENEFICIAL EFFECT OR NOT ON OUTCOMES, WHETHER THAT IS VIABILITY OR LONG TERM SURVIVAL OF THE ORGAN OR COMPLICATIONS OF THE SURGERY. THE FACT THAT SO YOU'RE ASKING A QUESTION AND YOU CAN'T PRESUME -- AND AGAIN YOU'RE GOING TO HEAR MY BIASES. YOU CAN'T PRESUME THE ANSWER TO THAT QUESTION IS GOING TO BE YES, IT HELPS. AND IF WHY ARE HONEST, I DON'T FEEL YOU CAN PRESUME TO SAY IT WON'T HURT EITHER. THAT'S WHY WE'RE DOING THE RESEARCH. SO FORGET WHAT YOU DO TO THE DECEASED DONOR BECAUSE THEY ARE NOT A HUMAN SUBJECT. THE ACTUAL PROCESS OF THANS PLANTING A MANIPULATED ORGAN, I HAVE TROUBLE COMING UP WITH CIRCUMSTANCES IN WHICH I PERSONALLY WOULD SEE THAT AS MINIMAL RISK AND WE ARE TALKING ABOUT MINIMAL RISK AS DEFINED IN THE REGULATIONS WHICH ARE VERY SPECIFIC AND IT'S HOW WE APPLY THEM EVERYWHERE ELSE [ READING ] TRADITIONAL INTERPRETATION IS SAY YOU'RE A CHILD WITH LEUKEMIA AND YOU'RE GETTING PLATELET TRANSPLANTS EVERY FOURTH DAY, THAT'S NOT SUPPOSED TO BE THE IN YOUR CASE, TO GET AN EXTRA TRANSFUSION, IT'S REALLY MINIMAL INCREMENTAL RISK THAN WHAT YOU'RE FACING. THAT'S NOT HOW WE ALWAYS INTERPRETED RISK. WE INTERPRETED IT EXPLICITLY NOT TO ALLOW EXPOSURE OF INDIVIDUALS WHO ARE IN RISKY CIRCUMSTANCES JUST BECAUSE WHERE THEY ARE AT THE MOMENT. BUT IRBs MAKE THIS DECISION ALL THE TIME. SO THIS IS ONE OF THE JUSTIFICATION FOR SINGLE AND CENTRAL IRBs SO WE HAVE A CONSISTENT AND JUSTIFIED DEFINITION, APPLICATION OF MINIMAL RISK. OTHERWISE THEY CAN TELL YOU AND IT WOULD BE ALL OVER THE BOARD. I PERSONALLY DON'T THINK THE RESEARCH THAT WAS DONE IN THE WAIVERED CONSENT WAS MINIMAL RISK. IF YOU'RE A FRANCE PLANT SURGEON, THE THINGS THAT PEOPLE ARE GOING THROUGH ON YOUR WATCH AND UNDER YOUR SUPERVISION, ARE SO HIGH RISK ANYWAY, THAT THE FACT THAT SOMEONE THAT A DONOR WAS COOLED BY 5 DEGREES OR TWO DEGREES CENTIGRADE BEFORE THE ORGAN WAS HARVESTED. IT'S SUCH A MINIMAL CHANGE IN WHAT THEY ARE ALREADY EXPOSING INDIVIDUALS TO THAT I HAVE TO SAY, IF I WERE THAT SURGEON, TO ME IT WOULD BE A NO-BRAINER. THIS WOULD MEET THE COMMON SENSE DEFINITION. THE DIFFICULTY IS THAT THAT IS NOT HOW WE INTERPRETED THE REGULATIONS. WE INTERPRETED THEM SPECIFICALLY TO NOT GIVE PRIVILEGE TO PEOPLE WHO ARE ALREADY AT HIGH RISK. DOES THAT HELP AT ALL? >> THANK YOU SO MUCH. SO BASICALLY THE CENTRAL IRB WOULD MAKE THE DETERMINATION OF WHETHER THIS WAS MINIMAL RISK OR NOT AND THEN THAT WOULD HAVE TO -- THAT DETERMINATION WOULD BE ACCEPTED BY WHEREVER THAT ORGAN GOES WHETHER IT IS THE INTENDED ORGAN FOR THE STUDY VERSUS BYSTANDER ORGANS. SO IF YOU'RE GIVING A KIDNEY, WHAT IS THE HEART DOING. THE HEART IS THE BYSTANDER. SO THE IRB, CENTRAL IRB MAKES A DETERMINATION, CALL THIS IS GREATER THAN MINIMAL RISK. SO WOULD THAT FALL ALSO UNDER THE SECRETARIAL WAIVER? >> YES. SO THE ONLY TIME THE SECRETARIAL WAIVER WOULD BE INVOKED, SO THERE ARE A COUPLE OF PATHS. THE WAIVER IS THE REQUIREMENTS FOR CONSENT. IF AN IRB FOUND THIS -- AND SO THESE KICK IN -- IF AN IRB FOUND IT WAS NO GREATER, THEY COULD WAIVE CONSENT AND YOU WOULDN'T INVOKE THE SECRETARIAL WAIVER AND [ INAUDIBLE ] >> SO THAT'S VERY HELPFUL. AND THE OTHER QUESTION IS, IN TERMS OF THE TRANSPLANT TEAMS IN THE INDIVIDUAL TRANSPLANT CENTERS, MY UNDERSTANDING, WHEN I READ THE NATIONAL ACADEMY OF MEDICINE, THE REPORT, WAS THAT THOSE TRANSPLANT TEAMS IN -- WHEREVER THEY ARE, WOULD BECOME COINVESTIGATORS IN THE STUDY SO THEY WOULDN'T JUST BE THE TECHNICIANS DOING THE TRANSPLANT BUT THEY WOULD BE CONSIDERED A COINVESTIGATOR. IS THAT YOUR UNDERSTANDING? SO I DON'T THINK WE ADDRESSED THAT. AND I CAN MAKE ARGUMENTS ON BOTH SIDES. I THINK THE REALITY OF IT IS THAT IT'S HARD TO CONSIDER A COINVESTIGATOR. SO IF YOU'RE A TRANSPLANT SURGEON, 250 CENTERS AND SAY 10 OR 20PDIR PROTOCOLS OUT THERE AND -- FOR EACH OF THOSE TRANSPLANT SURGEONS WOULD BE COMPLETELY CONVERSE ENT IN THE WAY THAT WE WOULD EXPECT AN INVESTIGATOR TO BE -- THE CHANCES THEY WILL EVER SEE SOMEONE WHO RECEIVED AN ORGAN UNDER THAT PROTOCOL -- I THINK IT RAISES QUESTIONS ABOUT WHAT IT MEANS TO CALL SOMEONE -- I DON'T KNOW WHAT THE ANSWER IS. THEY ARE COLLECTING CONSENT. I THINK THEY WOULD BE CONSIDERED RESEARCH. IT'S ANOTHER ASPECT OF THIS. IT DOESN'T REALLY FIT THE WAY WE HAVE DONE CLINICAL RESEARCH. AND SO, I DON'T WANT TO MINIMIZE IT. >> I AGREE BECAUSE THEY ARE AT RISK FOR SOME SORT OF LIABILITY IF THEY ARE BASICALLY -- IT'S INTERESTING TO MAKE THE DEFINITIONS BUT TO SAY THAT THEY ARE USING A STUDY ORGAN, IMPLANTING OR TRANSPLANTING IT AND THEN -- LET'S SAY THERE IS A BAD OUTCOME, WHATEVER IT IS, AND THEN THERE IS A CONCERN ABOUT LIABILITY OF THE TRANSPLANT CENTER HAVING TO USE THAT ORGAN. I MEAN, THEY NEED SOME SORT OF PROTECTION. >> I TOTALLY GET IT. I THINK THE MINIMUM THING YOU HAVE TO -- THE MINIMUM YOU HAVE TO REQUIRE, BEFORE THAT ORGAN IS OFFERED TO A RECIPIENT, IT NEEDS TO BE DEEMED APPROPRIATE FOR THAT RECIPIENT. THEY HAVE TO KNOW ENOUGH TO MAKE A DEFENSIBLE AND RESPONSIBLE CLINICAL DECISION. WHATEVER YOU CALL THEM, THEY HAVE TO HAVE ENOUGH INFORMATION TO MAKE THAT DECISION. I'M NOT GOING TO -- WE DIDN'T GET INTO HOW TO DO THAT. THAT'S AN AXE EXPECT OF THIS WE DIDN'T REALLY SPEAK TO. WE WERE CONCERNED ABOUT THE PARTICIPANT, NOT THE SURGEON. I MEAN, I THINK IT'S A GREAT -- WE ARE ASKING THEM TO MAKE A CLINICAL DECISION. THEY HAVE THE RIGHT TO REFUSE THAT ORGAN BEFORE AN INDIVIDUAL EVER TALKS TO THEM. I THINK I'M RIGHT ABOUT THAT. AND SO THEY HAVE TO KNOW ENOUGH TO MAKE A CLINICAL DECISION THAT THIS ORGAN IS APPROPRIATE FOR THAT INDIVIDUAL. AND SO THEY ARE GOING TO HAVE TO KNOW SOMETHING, POTENTIALLY QUITE A LOT, AND THE CIRCUMSTANCES OF THE MANIPULATION. BUT I'M REALLY TALKING OFF THE TOP OF MY HEAD. I THINK THAT IS DEFINITELY TRUE AND I THINK THERE SHOULD BE SOME LIABILITY PROTECTIONS AND THEY SHOULD BE PROVIDED BY IS IT THE CENTRAL STRUCTURES AND POTENTIALLY OTHER RULES. BUT I ALSO THINK YOU CAN'T TAKE AWAY THE RESPONSIBILITY OF THE SURGEON TO MAKE THAT DECISION. NO ONE ELSE IS GOING TO BE ABLE TO MAKE IT. AND SO THEY HAVE TO HAVE ENOUGH INFORMATION TO MAKE IT AND MAKE IT IN A WAY THEY FEEL IS DEFENSIBLE. >> I AGREE. I DON'T KNOW WHAT OR WHERE THIS GOES FROM HERE, BUT I AGREE WE NEED TO INCLUDE THEM IN THE PROTECTION. I AGREE. >> SKIP, YOU HAD YOUR HAND UP. >> YES, STEPHEN, JUST ONE QUICK COMMENT. I AGREE WITH THE APPROACH OF NOT WAITING INTO THIS MINIMAL RISK ISSUE WITHIN THE DOCUMENT BECAUSE IT IS COMPLICATED AND VERY CONTEXTUAL, BUT YOU DID SAY SOMETHING I'D LIKE TO JUST AMPLIFY OR MODIFY A BIT. I DON'T THINK THE ISSUE IS SO MUCH THAT THE INDIVIDUALS WERE FACING ORGAN TRANSPLANT SHARE A GREATER RISK AND THEN WE ARE ASKING THEM UNDER MINIMAL RISK TO ACCEPT GREATER MINIMAL RISK THAN SOMEONE ELSE MIGHT ACCEPT, WHICH IS WHAT YOU IMPLIED IS A VIOLATION OF JUSTICE. I THINK THE QUESTION IS, WHAT IS THE INCREMENTAL RISK OF THE RESEARCH ABOVE AND BEYOND THAT RISK THAT THEY ARE EXPERIENCING? YOU SAID SOMETHING ELSE THAT I THINK COULD BE EXPANDED ON, IF IN FACT THE INTERVENTION ON THE DECEASED DONOR IS SO MINIMAL, IT WOULD BE REASONABLE TO WONDER WHY THAT WOULD HAVE ANY EXPECTATION TO HAVE IMPACT ON THE SURVIVABILITY OF THE ORGAN. SO TO SAY SOMETHING IS ONLY A RISK OF DAILY LIFE INCREMENT ABOVE THEIR RESEARCH RISK, I THINK IT'S PROBLEMATIC. BUT I DON'T THINK IT'S AN ISSUE OF THE JUSTICE BEING EXPOSED TO MORE RISK. I THINK IT'S AN ISSUE OF THE IRB EVALUATING THE INCREMENTAL RISK OF RESEARCH OVER WHAT WOULD OTHERWISE BE HAPPENING. >> SO SKIP, I THINK THAT THAT IS A PERFECTLY COMMON SENSE IMPLICATION. IN MY EXPERIENCE, AND I KNOW THIS IS DONE DIFFERENTLY BY DIFFERENT GROUPS. THE IRS ACTUALLY NOT SUPPOSED TO LOOK -- THE IRB -- AT MINIMAL RISK AS INCREMENTAL BUT AS ABSOLUTE RISK. BUT I'M NOT SURE THAT'S IN SCOPE. >> UNDER PART A, IT SAYS THAT THE IRB IS SUPPOSED TO LOOK AT THE RISKS OF THE RESEARCH AND NOT AT THE RISKS OF WHAT THEY WOULD OTHERWISE RECEIVE. I MEAN I'M NOT QUOTING IT DIRECTLY BUT THAT'S, AS I RECALL, ONE OF THE CRITERIA UNDER SUBPART A. >> SO I THINK WE ARE USING THE SAME TERMS. I THINK WE ARE IN AGREEMENT. SO I TOTALLY AGREE WITH YOU. THE QUESTION OR THE POINT I WAS RAISING IS THAT AS A PRACTICAL MATTER, FORGET IRBs FOR THE MOMENT. CLINICIANS LOOKING AT RISKS OF A PROCEDURE WILL IN FACT TAKE INTO ACCOUNT THE INCREMENTAL RISK OF A PROCEDURE, AND THE RISK BACKGROUND FOR THAT INDIVIDUAL. AND MY UNDERSTANDING IS THAT IRBs ARE NOT SUPPOSED TO DO THAT. ABSOLUTELY. SO WE ARE USING INCREMENTAL RISK IN TWO DIFFERENT WAYS. YOU'RE ABSOLUTELY RIGHT. >> THAT'S FINE. AND THAT MAY BE WHAT THAT IRB DID. I DON'T KNOW THE DETAILS BUT THAT MAY HAVE BEEN THEIR LOGIC. >> I THINK IT PROBABLY WAS. I AGREE. SO LAUREN IS DOING SOMETHING TO THE DOCKET. OTHER COMMENTS? >> STEPHEN, THIS IS LESLIE. I HAVE MY HAND RAISED. IT'S NOT ALWAYS EASY TO LOOK AT OWL THOSE THINGS, PARTICULARLY WHEN YOU'RE PRESENTING. >> YOU NOTICED MY EYE TRACKING. I WOULD ENCOURAGE PEOPLE TO -- DO I NOT HAVE THE BALL? NO, I DO. SO PEOPLE, IF YOU RAISE YOUR HANDS, IT'S EASIEST FOR ME IF YOU RAISE YOUR HANDS ON THE WEBEX. BUT HAVING BEEN SAID, LESLIE, YOU MAY HAVE DONE THAT. >> WHICH I DID, BUT AS BEING MODERATOR AND LOTS OF RESPONDING TO OMMENTS AND ALL THAT, IT'S A LOT TO HANDLE. SO ONE, I JUST WANTED TO COMMENT ON WHAT A FANTASTIC JOB SHEPERDING THIS COMPLICATED ISSUE AND THIS DOCUMENT THROUGH. I MESSED THE MARCH MEETING BUT WAS ABLE TO PARTICIPATE IN THE PREVIOUS MEETINGS AND THIS IS SUPER CHALLENGING AND I WAS REALLY -- HAD VERY LITTLE TO SAY. I THINK WE ENDED UP IN THE RIGHT SPOT WITH THIS DOCUMENT AND JUST WANTED TO LEND MY COMPLIMENTS TO ALL OF THOSE WHO WERE PARTICIPATING IN THIS. THE ONE MINOR ISSUE I HAVE IS WHERE WE ARE SHARING ON THE SCREEN RIGHT NOW IN QUESTION 7, WHICH IS THAT ISSUE OF PRACTABILITY IN THE WAIVER AND I UNDERSTAND WHY YOU MADE THE MOVE YOU DID, STEPHEN, AND I'M NOT SUGGESTING AN ALTERATION OF THAT. I DID WANT TO COMMENT. MY VIEW HAS ALWAYS BEEN THAT PRACTABILITY REALLY IS ABOUT WHEN SOMEBODY IS NOT AVAILABLE, WHICH IS NOT THIS CASE. AND IT MAY BE WORTH JUST ACKNOWLEDGING THAT THIS IS A VERY DIFFERENT AND CONSTRAINED PRACTABILITY ISSUE. AND TO ACKNOWLEDGE THAT DISCOMFORT THAT PEOPLE MIGHT OTHERWISE HAVE. >> YOUR FIRST OBSERVATION IS WHY WE WENT THE OTHER WAY IN THE PREVIOUS DRAFT. YOU CAN SEE THE LANGUAGE. THE IT LITERALLY SAID -- BUT THEN WE GO ON TO TALK ABOUT HOW YOU HAVE PRACTICABILITY. BUT OTHERWISE, IT'S ESSENTIALLY THE SAME DISCUSSION. SO IT REALLY -- ANYWAY, IF YOU WERE TO DO A WAIVER, IT WOULD BE -- OR AN ALTERATION, IT WOULD PROBABLY BE TO DO A WAIVER. BUT I'LL THINK ABOUT THAT. >> I THINK IT REALLY JUST CALLING IT OUT. WE RECOGNIZE THIS IS DIFFERENT THAN WHAT WE USUALLY THINKING OF BUT GIVEN THESE CIRCUMSTANCES WE HAVE ARTICULATED IN SO MANY OTHER WAYS OF WHAT IS TRULY DIFFERENT ABOUT THIS CIRCUMSTANCE THAT HERE WE THINK -- AND SEE THE CONVERSATION LATER. >> YES. THANK YOU. I'LL TRY TO THINK OF SOMETHING TO DO WITH THAT. >> HI, I WANTED TO ECHO LESLIE'S COMMENT ABOUT HOW MUCH WORK THE COMMITTEE HAS PUT INTO THIS. SO, I THINK THE CONVERSATIONS WITH A COUPLE OF GROUPS HERE AT NIH THAT HAVE AN INTEREST IN THIS AREA AND I WANTED TO RELAY A COUPLE OF QUICK COMMENTS FOR YOU HERE. THE FIRST ONE IS RIGHT WHERE WE ARE LOOKING RIGHT NOW. AND I'M SORRY TO KEEP DISCUSSING THIS ONE SECTION BUT WITH THE PRIOR EDIT, IT ALSO SAID THAT IRBs MIGHT AUTHORIZE AN ALTERATION RATHER THAN A WAIVER. AND I TAKE YOUR POINTS IN THE CURRENT CONVERSATION AND THE FEAR THIS MAY BE A MOOT POINT NOW BUT I WANT TO RAISE THAT WHETHER THE COMMITEE CONSIDERED IS THAT ALTERATION OR THAT WAIVER IN THE EVENT AN IRB DID DO SO BECAUSE OF RISK, WHETHER THAT WAS ENVISIONED BY THE COMMITTEE TO BE SIMILAR IN TERMS OF THE CONTENT AND THE PROCESS TO WHAT WOULD BE DONE UNDER THE SECRETARIAL WAIVER. IT DOESN'T REALLY GO INTO THAT LEVEL OF DETAIL HERE. >> SO THERE ARE A COUPLE OF PIECES TO THE SECRETARIAL WAIVER. THE SUBSTANCE -- ALL WAIVERED. I THINK. SO IT BECOMES UNNECESSARY IN THAT CONTEXT. BUT, THERE ARE OTHER PARTS OF THE RECOMMENDATIONS IN WHICH THE SECRETARIAL WAIVER IS CONTINGENT. THAT SHOULD APPLY. SO I THINK THAT THAT IS A VERY GOOD OBSERVATION. I'M GOING TO TRY TO SCROLL, AND I DON'T KNOW. I MADE -- THERE WE GO. SO LET ME GO DOWN TO C. THE SECRETARIAL WAIVER REQUIRED -- RECOMMENDATION 1 IS STAND ALONE. SO I THINK THIS IS A DOCUMENT PARSING ISSUE. 2, SECRETARIAL WAIVER REQUIRED. AND MAYBE I SHOULD MAKE THE DOCUMENT EXPLICIT THAT THE SECRETARIAL WAIVER APPLIES TO GREATER RESEARCH THAT WOULD OTHERWISE NEED CONSENT. THE SECRETARIAL WAIVER IMPLICATES OTHER -- 3-7 OR 8 OR 9 -- 3-9, AND REQUIREMENTS FOR SECRETARIAL WAIVER. BUT THOSE ARE ALSO -- AND I DON'T KNOW HOW TO STRUCTURE THE DOCUMENT. MAYBE I JUST NEED TO SAY IT EXPLICITLY. THEY ARE ALSO INDEPENDENT RECOMMENDATIONS SO SACHRP MADE NINE RECOMMENDATIONS. RECOMMENDATION TWO WAS THE SECRETARIAL WAIVER BE REQUIRED. RECOMMENDATION 2 WAS CONTINGENT ON SOME OF THE OTHER RECOMMENDATIONS. BUT IF YOU SAY YOU WAIVE CONSENT, IT DOESN'T MEAN -- SO ALL OF THE OTHER RECOMMENDATIONS ARE NOT PART OF THE SECRETARIAL WAIVER. THEY ARE SEPARATE BUT -- IF THAT MAKES SENSE? OR IS IT MORE CONFUSING? >> AS YOU'RE SAYING IT, IT DOES MAKE SENSE. I DON'T THINK IT WAS NECESSARILY READ THAT WAY. >> OKAY. SO I'M GOING TRY TO THINK OF WAYS TO MAKE THAT CLEARER BECAUSE I THINK IT IS REALLY IMPORTANT. THERE ARE TWO SEPARATE ISSUES. THE SECRETARIAL WAIVER IS ONLY REQUIRED -- AND MAYBE THIS IS THE LANGUAGE I NEED TO PUT IN. IT'S ONLY REQUIRED IN THE CIRCUMSTANCES IN WHICH IT'S GREATER THAN MINIMAL RISK. ARE AND THAT'S TOTALLY APPROPRIATE I SHOULD MAKE THAT CHANGE. >> AND I HAD ONE OTHER QUESTION AS WELL. IT'S MORE GENERAL, WHICH IS REALLY WHETHER THE COMMITTEE, THE EXTENT TO WHICH THEY CONSIDERED IMPLEMENTATION CHALLENGES, THAT MIGHT STEM FROM STANDING OUT THE RECOMMENDED ENTITIES FOR THE NATIONAL ACADEMY'S REPORT SO THE D ROCK AND THE DSMB AND WHETHER THAT FACTORED INTO THE RECOMMENDATIONS HERE. EVEN WITH THE WAIVER. AND WHETHER THERE IS ANY THOUGHTS AS TO HOW QUALITY COULD BE ASSURED IN CERTAIN STEPS THAT ARE BEING CONTEMPLATED HERE BEING AN INFORMATION PROVIDED DURING ORGAN OFFER CALL. >> SO, TO THE FIRST POINT, THE RECOGNITION OF THE BURDEN OF CREATING THESE ENTITIES IS THE REASON WE DIDN'T MAKE THEM REQUIRED FOR THE SECRETARIAL WAIVER. ON THE OTHER HAND, TALKING TO THE PEOPLE WHO HAVE BEEN ON THE PANELS, TO DR. NEHMAN, THIS RESEARCH IS SIMPLY NOT HAPPENING NOW, LARGELY BECAUSE OF THE COMPLEXITY, THE BURDEN AND REGULATORY -- LACK OF REGULATORY CLARITY. SO I THINK IT'S ONE OF THOSE THINGS, LIKE A LOT OF THE PROVISIONS OF THE UPDATED RULE IF YOU'LL GIVE ME THE LIBERTY. IT'S GOING TO BE A SLOG TO PUT ALL OF THIS IN PLACE. BUT WHERE WE WILL END UP, WE'LL ALLOW THIS KIND OF RESEARCH IN A WAY WE SIMPLY CAN'T DO IT NOW. AND THE ONE THING WE HEARD NO CONTROVERSY FROM ANY IS THE NECESSITY FOR THIS RESEARCH TO GO AWAY. SO I THINK THAT WE DON'T IN ANY WAY -- WE DIDN'T GET INTO THE DETAILS OF HOW HRSA PRESUMABLY WOULD STAND THESE ENTITIES UP WHERE THE RESOURCES WOULD COME FROM ANY OF THAT. I THINK THAT IS BEYOND MOST OF OUR AREAS OF EXPERTISE. THAT BEING SAID, THE ENVIRONMENT THAT WAS PRESENTED TO US AND TO THE NATIONAL ACADEMIES IS IF YOU TRIED TO DO THIS WITHOUT CENTRALIZATION, YOU WOULDN'T. I MEAN THE RESEARCH UTILIZATION MIGHT NOT BE VISIBLE BUT THE RESOURCES REQUIRED TO DO IT WELL AND EQUITABLY WOULD BE MUCH, MUCH GREATER THAN STANDING UP -- SO I DON'T KNOW WHETHER IT'S WORTH SAYING EXPLICITLY. THIS IS NOT MEANT TO BE A SUGGESTION TO INCREASE EFFICIENCY. IT'S MEANT TO BE A SUGGESTION THAT WILL ALLOW SUFFICIENT DEFICIENCIES SO MUCH-NEEDED RESEARCH CAN MOVE FORWARD. IT WILL COME AT SOME COST. THAT COST IS NOT BEING SPENT NOW BECAUSE THE RESEARCH IS NOT BEING DONE. SO, I MEAN, I THINK THAT'S THE WAY TO LOOK AT IT. AND ULTIMATELY, THOSE AGENCIES WILL HAVE TO DECIDE WHETHER IT'S WORTHWHILE OR NOT. IF WE WANT TO PROMOTE THIS KIND OF RESEARCH. WE HEARD OVER AND OVER AGAIN ABOUT THIS. AND REMIND ME ABOUT THE SECOND PART. >> SURE. IT WAS JUST SORT OF WHETHER THE COMMITTEE HAD GIVEN ANY THOUGHT TO HOW QUALITY CAN BE ASSURED IN CERTAIN STEPS THAT ARE BEING PROPOSED, LIKE THE INFORMATION PROVIDED DURING THE ORGAN OFFER CALL. >> SO, I THINK THOSE CONCERNS WERE WHAT WAS BEHIND THE REQUIREMENT THAT STANDARDIZED EDUCATIONAL MATERIAL BE DEVELOPED FOR BOTH TRANSPLANT RECIPIENTS AND TRANSPLANT TEAMS BY THE CENTRAL IRB. AND WE, I BELIEVE, CALLED FOR THAT STANDARDIZED EDUCATION. IT'S ABOUT DDIR. IT'S NOT JUST ABOUT THE SINGLE PROTOCOL. BUT YOU HAVE THE KEY INFORMATION SECTION. BUT WE TALKED ABOUT FRAMING ORAL CONSENT AND WE TALKED ABOUT STANDARDIZED MATERIALS AND I DON'T KNOW -- THOSE WILL BE DEVELOPED BY THE CENTRAL IRB, SINGLE IRB. I DON'T KNOW HOW YOU GO -- IT'S A MUCH BIGGER DISCUSSION TO EVALUATE THE QUALITY. I THINK THAT'S SOMETHING WE STRUGGLED WITH FOR YEARS. BUT THAT IS WHAT WE FELT BY PUTTING THIS ON THE SHOULDERS OF AN ORGANIZATION THAT WAS SUPPOSED TO BE RESPONSIBLE, ULTIMATELY FOR PROTECTION OF THE PARTICIPANT, THAT WAS THE BEST WAY TO SHARE THAT CALL. IT'S A MUCH BUGGER QUESTION WHETHER THAT ALL WILL WORK THAT WAY. DOES THAT HELP? >> YES, IT DOES. THANK YOU VERY MUCH. >> OTHERS? SO, HERE ARE THE CHANGE THAT IS I INTEND TO MAKE. I WANT TO CLARIFY THAT THE PRACTICABILITY DISCUSSION IS SPECIFIC IN THE CONTEXT OF WAIVER OF CONSENT, AND SPECIFIC TO DDIR. AND THEN I WANT TO MAKE CHANGE THAT IS MAKE IT CLEAR THAT RECOMMENDATIONS 3-9, EVEN THOUGH WE FOLLOW THE RECOMMENDATIONS OF THE SECRETARIAL WAIVER, STAND ALONE AND THE SECRETARIAL WAIVER -- I THINK THE BEST WAY TO DO THAT IS TO ADD LANGUAGE TO THE RECOMMENDATION 2 THAT THE SECRETARIAL WAIVER IS TO BE USED IN THE CONTEXT WHERE GREATER THAN MINIMAL RISK RESEARCH OR CONSENT -- SO THOSE ARE THE TWO CHANGES THAT I HAVE. ANYTHING ELSE PEOPLE WANT TO ADD? BECAUSE I HAVE TO TELL YOU, IT'S BEEN 18 MONTHS. I THINK IT'S TIME TO PASS THIS OFF TO THE PEOPLE WHO CAN ACT ON IT. SO I WOULD REALLY LIKE TO GET THIS VOTED ON. MAYBE I CAN -- ANY LAST COMMENTS? THANK YOU. SO WE DON'T HAVE ANOTHER BREAK. WE MOVE RIGHT INTO THE BEGINNING OF THE DISCUSSION OF PUBLIC HEALTH SURVEILLANCE. DAVID, YOU CAN BRING UP THAT DOCUMENT, YES? >> DR. FORSTER: CORRECT. I WILL NEED -- DO YOU HAND THE BALL TO ME OR DO I JUST TAKE CONTROL? >> DR. ROSENFELD: LET ME STOP SHARING AND I THINK IT WORKS BOTH WAYS BUT I'M THERE SO I'LL JUST DROP IT ON YOU. >> STEPHEN, THIS IS MARK. I WANTED TO NOTE THAT I HAVE DONE ALL OF THE CHANGES THAT I THINK PEOPLE ASKED FOR IN THE STUFF WE DISCUSSED ON THE AGENDA. I CAN EITHER DO THAT NOW AND GET RID OF IT QUICKLY OR GO TO DAVID, WHATEVER YOU WANT. >> DAVID HAS TO LEAVE AT 4:00. >> DR. ROSENFELD: I GUESS WE'RE GOING TO DAVID AND THEN WE'LL COME BACK TO YOU. >> DR. BARNES: THAT'S FINE. I WAS JUST GOING TO OFFER. >> DR. FORSTER: ALL RIGHT. THANK YOU ALL. AND I WOULD LIKE TO SAY WELCOME TO KEVIN AND DOUG. I HAVEN'T CROSSED PATH WITH EITHER OF YOU FOR SEVERAL YEARS BUT I WAS PLEASED TO SEE YOUR NAMES SHOW UP AS NEWEST MEMBERS. SO WELCOME. THIS IS ABOUT A NEW EXCLUSION THAT WAS ADDED TO THE 2018 REQUIREMENTS, THE NEW VERSION OF THE COMMON RULE. AND IT WAS VERY TIMELY. IT WAS PUT IN THE 2018 VERSION AND THEN VERY PROMPTLY HERE WE HAVE THE CORONAVIRUS PANDEMIC. AND SO THIS BECAME APPLICABLE, OR POTENTIALLY APPLICABLE TO A LOT OF PROJECTS THAT WERE BEING DONE IN REGARDS TO THE PANDEMIC AND ALSO JUST ALSO OTHER ACTIVITIES SEPARATE OVER THE COURSE -- IT RAISED THE CONCERN ABOUT IT. AND AS SOMEONE COMMENTED EARLIER IN OUR DISCUSSIONS AT THE SUBCOMMITTEE LEVEL, THIS COULD BROADLY YOU CAN DRIVE ALMOST ANY RESEARCH PROJECT THROUGH A LOOPHOLE. AND SO THERE WAS A CONCERN THAT IF YOU CONSIDER FOR INSTANCE NIH TO BE A PUBLIC HEALTH RESEARCH AGENCY OR -- EXCUSE ME, A PUBLIC HEALTH AGENCY AND THEN BROADLY DETERMINED WHAT PUBLIC HEALTH SURVEILLANCE ACTIVITY IS, ALMOST ANYTHING NIH COULD DO AND ANY KIND OF RESEARCH COULD BE INTERPRETED AS FITTING THIS EXCLUSION. AND SO THAT WAS KIND OF THE CONCERN, THE BROAD CONCERN. AND THEN THE FINE DETAILS OF WHEN IT APPLIES AND HOW TO APPLY IT. THAT IS THE PURPOSE OF THIS RECOMMENDATION. IT CAME FROM OHRP BUT HAD INPUT FROM SEVERAL OTHER AGENCIES AS WELL, IS MY UNDERSTANDING. AND IT IS DIVIDED INTO A SERIES OF EIGHT QUESTIONS. SO THE QUESTIONS ARE FAIRLY SPECIFIC. SO WHAT I THINK I'LL DO IS GIVE A BROAD OVERVIEW AND THEN WE'LL ADDRESS THIS QUESTION BY QUESTION AND GET INPUT FROM THE SACHRP MEMBERS RATHER THAN GO THROUGH THE WHOLE DOCUMENT. THE THE FINAL PART OF THE DOCUMENT IS TO PROVIDE OUR COMMENTARY ON THE DRAFT GUIDANCE FROM OHRP ON HOW TO INTERPRET THIS AND IN THE END, WE PRETTY MUCH SAID WE AGREE WITH EVERYTHING IN THERE. IT LOOKS FINE. AND THEN WE PUT TOGETHER AN ALGORITHM TO GO THROUGH IT. THERE IS AN ALGORITHM AT THE END OF THIS DOCUMENT THAT IS FAIRLY STRAIGHTFORWARD AND PRETTY MUCH QUOTES REGULATORY LANGUAGE AND THEN SOME EXAMPLES FROM THE PREAMBLE. AND THEN STEPHEN PUT TOGETHER A SEPARATE ALGORITHM WE'LL LOOK AT AFTERWARDS IF WE HAVE TIME, THAT HAS THE MORE NARRATIVE TEXT IN IT AND THE SLIGHTLY DIFFERENT ARRANGED. SO, I DON'T IMAGINE WE WILL GET THIS APPROVED OVER THE COURSE OF THESE TWO DAYS BUT IF WE DO, THAT IS GREAT, AND IF NOT, IT CAN COME BACK. SO, STARTING WITH THE BROAD OVERVIEW, OHRP PROVIDED A SERIES OF QUESTIONS TO SACHRP AND ASKED FOR OUR RESPONSE. THE QUESTIONS ARE ALL ABOUT 45CFR, 46102K AND L2. SO ONE 02K IS THE DEFINITION OF A PUBLIC HEALTH AUTHORITY. AND YOU CAN SEE THE DEFINITION ON THE SCREEN. AND THEN 102L2 IS THE ACTUAL EXCLUSION. SO IT'S PUBLIC HEALTH SURVEILLANCE ACTIVITIES INCLUDING THE BROAD LIST THAT CONDUCTED OR REQUESTED AND REQUIRED AND AUTHORIZED BY PUBLIC HEALTH AUTHORITY. AND THERE ARE LIMITS TO ALLOW THE PUBLIC HEALTH AUTHORITY TO TAKE CERTAIN ACTIONS REGARDING THESE PUBLIC HEALTH ISSUES. >> DAVID, I'M SO SORRY. IT'S JULIA. CAN YOU POSSIBLY ZOOM IN A LITTLE BIT TO MAKE THE TEXT EASIER TO READ ON THE VIDEOCAST? >> DR. FORSTER: OF COURSE. SORRY ABOUT THAT. DOES THAT HELP? >> I THINK THAT IS MUCH BETTER. THANK YOU. >> DR. FORSTER: OKAY. ALL RIGHT. AND I DOES WANTED TO MENTION A NOTE OFF TO THE SIDE THAT THE QUESTION THAT CAME FROM OHRP USED THE TERM, EXCEPTIONS. AND JANET, THANK YOU. YOU ASKED FOR AN EXPLANATION OF THAT. I WAS DISCUSSING WITH THE FOLKS FROM OHRP, WE CAME TO THE CONCLUSION THAT EXCLUSIONS WAS THE BETTER TERM THAN EXCEPTIONS. AND THE REASON BEING IS THAT EXCLUSION WAS THE WORD USED IN BOTH THE NPR THAT ORIGINALLY CAME OUT AND IN THE PREAMBLE TO THE REVISED RULE. SO I JUST CHANGED EXCEPTION TO EXCLUSION, ALL THE WAY THROUGH. AND THEN THERE IS A FUNNY THING THAT THE TERM, EXCLUSION, IS NOT ACTUALLY USED IN THE COMMON RULE. WHAT IT SAYS IS, YOU'LL SEE HERE WHERE I HAVE MY -- IT SAYS THERE ARE FOUR ACTIVITIES WHICH ARE DEEMED NOT TO BE RESEARCHED. SO THEY ARE NOT CALLED EXCLUSIONS, THEY ARE JUST DEEMED NOT TO BE RESEARCH. SO IT'S TRICKY HERE BUT YOU KNOW. WE CAN TALK ABOUT IT AFTER THE MEETING. THEN WE HAVE SOME OPENING COMMENTS AND THIS CAME FROM STEPHEN ORIGINALLY. AND IT WAS REALLY JUST AN EFFORT TO DISTINGUISH BETWEEN RESEARCH AS IT IS DEFINED UNDER THE COMMON RULE AND COMMONLY UNDERSTOOD BY ALL OF US IN THE COMMUNITY. AND PUBLIC HEALTH SURVEILLANCE ACTIVITIES. AND REALLY THE THRUST OF THESE FIRST THREE PARAGRAPHS IS THAT IT'S THE PURPOSE. WHAT REALLY MATTERS IS THESE ACTIVITIES LOOK VERY SIMILAR. AND COULD BE THE SAME ACTIVITY. AND IT'S REALLY THE PURPOSE TO WHICH THE ACTIVITY IS DRIVEN OR WHAT IS BEING DONE TO ACCOMPLISH. AND SO WE WANTED TO POINT THAT OUT. AND THEN WE ALSO JUST BROADLY SAID STARTING ON LINE 69-73 THAT JUST BECAUSE THE PUBLIC AGENCY IS DESIGNATED A PUBLIC HEALTH AGENCY, IT DOESN'T MEAN THAT EVERYTHING THEY DO IS A PUBLIC HEALTH SURVEILLANCE ACTIVITY OR PUBLIC HEALTH ACTIVITY. THIS IS AN EFFORT TO NARROW THE INTERPRETATION OF THIS. AND THEN SECOND, JUST TO POINT OUT THAT IF THIS EXCLUSION DOES NOT APPLY, THE OUTCOME IS THAT IT THEN NEEDS TO BE DETERMINED WHETHER IT MAKES AN EXEMPTON OR NEEDS EITHER EXPEDITED OR FULL BOARD IRB REVIEW. SO IT'S NOT THE END OF THE WORLD. NOT LIKE YOU CAN'T DO THESE ACTIVITIES IF THEY DON'T MEET THE EXCLUSION. THE THEY ARE NOT A PUBLIC HEALTH SURVEILLANCE ACTIVITY BUT THEY JUST NEED THAT OVERSIGHT WE EXPECT OF RESEARCH. THOSE ARE THE OPENING COMMENTS. AND I GUESS -- I DON'T RECALL HOW TO SEE HANDS UP. >> DAVID, THIS IS SKIP. I JUST MADE A COMMENT. I DON'T THINK WE NEED TO WORD SMITH IT NOW BUT I FIND THE OPENING COMMENTS CONFUSING. AND TO IMPLY -- THERE IS A TENSION BETWEEN THE LANGUAGE OF YES, THERE IS SOME ACTIVITIES THAT ARE RESEARCH. THERE ARE SOME ACTIVITIES THAT ARE PUBLIC HEALTH AND THERE ARE SOME ACTIVITIES THAT ARE BOTH. BUT THEN SOME OF THE CONCEPTUAL LANGUAGE ATTEMPTS TO MAKE A STRONGER DISTINCTION BETWEEN THE TWO OF THEM AND I FOUND THAT IN THIS DOCUMENT, AS WELL AS THE ONE THAT WAS SENT, WHICH IS IN THE PDF, AND I THINK THEY ARE JUST CONCEPTUALLY NOT ACCURATE. I MEAN PUBLIC HEALTH SURVEILLANCE CAN RESULT IN GENERALIZABLE KNOWLEDGE. IT CAN. SO THAT IS THE TENSION SOMEHOW WE NEED TO CARVE THAT OUT. BUT I AGREE WITH THE CONCERN OF NOT HAVING IT COVER EVERYTHING THAT AN AGENCY WHO MIGHT BE SEEN AS HAVING A PUBLIC HEALTH ROLE WOULD DO. SO I AGREE WITH THAT. BUT I THINK THIS WHOLE SECTION NEEDS MUCH MORE CAREFUL EXPOSITION. >> AND IT STARTED OFF WITH THE IDEA OF A VIN DIAGRAM WHERE YOU HAVE ACTIVITIES THAT ARE RESEARCH AND ACTIVITIES THAT ARE PUBLIC HEALTH SURVEILLANCE AND THERE IS AN OVERLAP. IT'S AN EFFORT TO DESCRIBE THE ACTIVITIES IN OVERLAP AND HOW TO DEFINE THEM AND THEN WHAT TO DO WITH HOME. >> WE AGREE WHERE WE WANT TO GO. I JUST FIND THE LANGUAGE DOESN'T QUITE GET THERE BECAUSE IT SORT OF IMPLIES THINGS THAT ARE PUBLIC HEALTH AREN'T RESEARCH -- I WOULD ALSO GET RID OF WHAT YOU'RE SAYING ABOUT THE FDA REGULATIONS. THE FDA IS ABOUT BROAD SCIENTIFIC PROGRESS SO I GUESS AS A FORMER PERSON AT THE FDA II WOULD TAKE THE IMPLICATION THAT IT'S NOT ABOUT PROGRESS AND JUST ABOUT SOCIAL UTILITY FOR CLINICAL PRACTICE. >> OKAY. THAT'S GOOD COMMENTARY. THANK YOU. AND I THINK SINCE I'M TECHNOLOGICALLY CHALLENGED AND CAN'T SEE THE HANDS, PEOPLE WILL JUST HAVE TO SPEAK UP. >> SO DAVID, I JUST WANTED TO RESPOND TO SKIP. I THINK THIS IS AN IMPORTANT POINT. AND WE MAY JUST UNDERSTAND IT DIFFERENTLY AND I DON'T KNOW HOW IPORTANT IT IS WE UNDERSTAND IT THE SAME WAY BUT MY UNDERSTANDING OF THIS IS THAT THERE IS THE DEFINITION OF RESEARCH THAT'S USED IN THE REGULATIONS. THIS IS NOT AN EXCEPTION. IT'S NOT AN EXEMPTION T IS SIMPLY NOT RESEARCH. IT'S NOT REACH BY VIRTUE OF BEING PUBLIC HEALTH SURVEILLANCE. AND SO, TO SAY SOMETHING CAN BE A PUBLIC -- IT'S NOT THAT IT CAN'T BE USED FOR GENERALIZABLE KNOWLEDGE. IT'S THAT THOSE CRITERIA, YOU JUST BY BEING NEEDED TO MAINTAIN PUBLIC HEALTH, IT TAKES IT OFF THE TABLE. IT'S NOT RESEARCH. IT'S NOT AN EXCEPTION FOR RESEARCH OR EXCLUSION OR AN EXEMPTION FROM RESEARCH. IT'S SIMPLY NOT RESEARCH, WHICH IS WHAT I WAS TRYING TO GET AT. I THINK THAT'S A FUNDAMENTALLY DIFFERENT UNDERSTANDING. >> AND WE ARE GOING TO HAVE TO WORK ON THAT BECAUSE THE WAY I WOULD SEE IT IS IF -- LET'S TAKE AN EXAMPLE OF WHAT MIGHT BE A PUBLIC HEALTH ACTIVITY AND LET'S SAY POISON CONTROL REPORTING AND THE SURVEILLANCE OF THE POISON CONTROL DATA. YOU CAN TAKE THOSE DATA AND THEN DRAW THE CONCLUSION ABOUT THE POPULATION THAT IS BROADER THAN SIMPLY THE POPULATION IN THAT DATABASE. THAT IS IN FACT AN INFERENCE A LARGER POPULATION FROM A SMALLER POPULATION, WHICH IS GENERALIZING THAT DATA. SO IT FITS THE RESEARCH DEFINITION. THAT'S MY CLAIM. FROM A PHILOSOPHICAL POINT ABOUT THE NATURE OF THE DESCRIPTIVE INFERENCE. AND SO, IT'S RESEARCH BUT IT'S NOT COVERED UNDER THE IRB AUTHORITY WHICH IS PUBLIC HEALTH FOCUS. >> SO I'LL MAKE ONE COMMENT AND THEN I'LL LET OTHERS SPEAK. I DON'T THINK IT'S -- I THINK THE COMMON USE OF THE WORD RESEARCH IS NOT WHAT WE ARE TALKING ABOUT AND I THINK WHAT THE CIRCUMSTANCE YOU DESCRIBE WOULD IN FACT BE COVERED AND ORIGINAL ACTIVITY THEY IS PUBLIC HEALTH SURVEILLANCE AND SUBSEQUENT USE OF THAT DATA IN RESEARCH THAT WOULD BE RESEARCH AND REQUIRE AN IRB. >> BUT THE CDC AND THE FDA DO THAT ALL THE TIME AND I DOUBT THEY GO TO AN IRB TO SAY CAN WE LOOK AT OUR DATA TO DRAW GENERALIZE CONCLUSIONS. >> I'LL LEAVE THAT UP. >> IF YOU LOOK THAT THE DATA YOU NEED AN IRB. BUT IF THEY LOOK AT THE DATA, THEY DON'T. >> WE SPENT A LOT OF TIME AT THE TRUMP LEVEL COMMITTEE DISCUSSING THIS ISSUE. IN THE END, IT'S A PHILOSOPHICAL ISSUE. SO I THINK IF WE ANSWER THE QUESTIONS AND IT'S CLEAR WHAT THE EXCLUSION APPLIES TO, WE DON'T REALLY HAVE TO GET TO THIS. SOMEONE ELSE IS GOING TO COMMENT? >> THAT MAY BE A REASON TO LOOK AT THIS AND HAVE A DIFFERENT REACTION THAN SKIP'S BUT ALSO HAD SOME CONCERNS WITH THE STATEMENTS IN BEING VERY BROAD, INCLUDING THAT THE COMMON RULE ARTICULATES ETHICAL PRINCIPLES AND SETS OF EXPECTATION BUSY HOW WE TREAT EACH OTHER BUT IT'S IN A PARTICULAR CONTEXT. SO THE WAY SOME OF THIS IS WRIT SEN BROADER. SO I'M NOT SURE THAT IT IS DOING A LOT OF WORK. IT MAY NOT BE THAT HELPFUL. IS IT ENOUGH DISCUSSION -- AND SKIP AND I ARE COMING TAT FROM DIFFERENT PERSPECTIVES. MAYBE WE COME BACK TO IT LATER HAVING ANSWERED THE QUESTIONS. BUT RATHER THAN GET BOGGED DOWN THAT THE POINT, IT MAY NOT BE THAT USEFUL. WE SORT OF HEARD SOME COMMENTARY AND THEN SORT OF LOOKED BACK AT THE END. SORT OF WRITE A LOT OF PAPER. THE INTRODUCTORY STUFF MAY BECOME CLEARER AS WE GRAPPLE WITH THE REST OF IT. >> OKAY. I LIKE THAT. >> IF I COULD MAKE A POINT. I THINK THAT THIS ISSUE OF WHETHER PUBLIC HEALTH SURVEILLANCE ACTIVITIES CONSTITUTE RESEARCH HAS BEEN THE SUBJECT OF A LOT OF ATTENTION. I WOULD INVITE THE WORKING GROUP TO REVIEW THE WHITE PAPER PREPARED BY PRIMERO THE BOUNDARIES OF RESEARCH. AND ESSENTIALLY WHAT IT ATTEMPTED TO DO WAS TO TRY TO FUSE OUT WHAT IS SURVEILLANCE AND OTHER ACTIVITIES SUCH AS QUALITY IMPROVEMENT ACTIVITIES WITHIN HOSPITALS AND WHETHER THOSE ARE ACTUALLY RESEARCH ACTIVITIES AS OPPOSED TO WHAT WE THINK OF AS TRADITIONAL HYPOTHESIS-DRIVEN RESEARCH. I THINK THAT WOULD BE A HELPFUL RESOURCE. I ALSO WOULD JUST HIGHLIGHT THAT I'M NOT SURE THAT IT IS REALLY A CURRENT DEFINITION. IT'S A CLASSICAL REACTIVE PUBLIC HEALTH SURVEILLANCE DEFINITION. ONE THAT DOES NOT INCORPORATE SUCH THINGS AS WEARING A MASK, FOR EXAMPLE. THE CDC WOULD BE INTERESTED IN MONITORING THE IMPACT OF MASK WEARING IN TERMS OF DISEASE INCIDENCE, BUT THAT IS -- BUT THAT SORT OF ACTIVITY DOES NOT FALL -- AND I DON'T THINK THAT'S A HYPOTHESIS NECESSARILY. A HIGH PROCESS SIS-DRIVEN RESEARCH ACTIVITY. IT'S A RESPONSE TO POLICY MONITORING THE IMPACT OF A POLICY. THAT WOULD FIRMLY BE WITHIN THE BUCKET OF PUBLIC HEALTH SURVEILLANCE ACTIVITIES. SO I WOULD INVITE THE WORKING GROUP TO TRY TO TAKE A LITTLE BIT MORE EXPANSIVELY ABOUT THIS ISSUE THAN THE CURRENT DEFINITION PROVIDES. >> THIS IS MARY ELLEN. A FOLLOW ON COMMENT TO SKIP'S REGARDING LINES 52 BUILT PURPOSES OF THE FDA REGULATION. I PROPOSE WE DELETE IT BECAUSE I DON'T THINK IT CAPTURED THE PURPOSE OF THE FDA REGULATION TO PROTECT PUBLIC HEALTH BY ENSURING THE SAFETY EFFICACY AND DEVICES. SO I THINK IT IS REALLY -- I JUST THINK IT WOULD SIMPLIFY THIS DOCUMENT BY SIMPLY DELETING THAT. >> I CONSIDER IT DELETED. OKAY. I'M GOING MOVE ON TO QUESTION 1. SO AGAIN, I WANT TO -- AS I MENTIONED, THE SUBCOMMITTEES FELT IN WORKING ON THIS DRAFT, THAT THIS EXCLUSION SHOULD BE NARROWLY INTERPRETED. SO YOU'RE GOING TO SEE THAT FOCUS ON THE RESPONSES TO MOST OF THESE QUESTIONS. AND WITH THAT, IT'S KIND OF A BACKGROUND. THE FIRST QUESTION IS, WHAT SHOULD BE CONSIDERED TO MEET THE COMMON RULE DEFINITION OF A PUBLIC HEALTH AUTHORITY AND THEY NOTE THAT HIPPA HAS A VERY SIMILAR DEFINITION. AND SO PERHAPS WE SHOULD LOOK AT THAT. AND I DID PUT THE HIPPA DEFINITION HERE. THE ONE THING THAT IS DIFFERENT IS THAT THE HIPPA DEFINITION DOESN'T INCLUDE A FOREIGN GOVERNMENT, WHICH IS IN THE COMMON RULE DEFINITION. SO WE HAD THREE STATEMENTS SO FAR TO THIS QUESTION. OR RESPONSES. FIRST WE NOTE THAT WE SUPPORT HARMONIZATION. THAT IS ONE OF THE SUBCOMMITTEES ON HARMONIZATION AND WE CERTAINLY WANT TO MAKE SURE THAT PAST INTERPRETATIONS BY OCR ARE CONSIDERED. AND THAT COMES LATER IN QUESTION 3 AND 4. MORE REFERENCE TO PREVIOUS OCR AND CDC GUIDANCE ON THIS ISSUE. THAT SHOULD BE ONLY FOR RESEARCH CONDUCTED IN THAT COUNTRY, THE COUNTRY OF THAT GOVERNMENT THAT SHOULD NOT ALLOW A FOREIGN GOVERNMENT TO CONDUCT PUBLIC HEALTH SURVEILLANCE ACTIVITIES IN THE U.S. OR IN ANOTHER COUNTRY THAT IS NOT THAT GOVERNSES. AND THEN THIRD, WE NOTED THAT THE WAY THE DEFINITION IS WRITTEN FROM A PLAIN READING, IT SEEMS THAT AS LONG AS A PERSON OR ENTITY HAS A GRANT OF AUTHORITY FROM OR A CONTRACT WITH A PUBLIC AGENCY, IT BECOMES A PUBLIC HEALTH AUTHORITY. AND I KNOW ONE OF THE EARLY POINTS THAT PEOPLE CONSIDERED IS WHETHER ONLY GOVERNMENT AGENCIES CAN BE PUBLIC HEALTH AUTHORITIES. AND I DON'T THINK FROM THE WAY THAT THE DEFINITION IS WRITTEN, THAT IS ACCURATE. AND THEN QUESTION 1A, IT'S A SUBSET THAT TALKS ABOUT GOING INTO A PARTNERSHIP WITH A PRIVATE INSTITUTION. IS THAT ENTITY A PUBLIC HEALTH AUTHORITY? AND AS I JUST SAID, WE WENT THROUGH MORE DETAIL HERE AND LOOKED AT THE DEFINITION AND SAID THAT IT CERTAINLY APPEARS THAT IF THERE IS A GRANT OF AUTHORITY OR CONTACT WITH A PUBLIC AGENCY, THEN THE PRIVATE INSTITUTION IS A PUBLIC HEALTH AUTHORITY. THEN WE WENT ON AND SAID THIS SHOULD BE INTERPRETED NARROWLY AND THE GRANT OF AUTHORITY OR CONTACT SHOULD BE CLEARLY LIMITED TO DEFINED PUBLIC HEALTH SURVEILLANCE ACTIVITY AND NOT ALLOWED TO EXTEND TO OTHER ACTIVITIES OR STUCK IN OTHER ACTIVITY WITHIN THE EXCLUSION. AND WE AGREED IN THE PREAMBLE COMMENTS, SUBSEQUENT USE OF THE DATE OR SAMPLES GATHERED UNDER THE PUBLIC HEALTH SURVEILLANCE ACTIVITY EXCLUSION WOULD NEED TO BE FURTHER ANALYZED TO SEE WHETHER THEY STILL FALL UNDER EXCLUSIONS OR MEET AN EXEMPTION, ET CETERA. IT'S NOT THAT ONCE SOME DATA OR SAMPLES FALL UNDER THIS EXCLUSION THEY ARE FOREVER UNDER THE EXCLUSION. THAT DOESN'T FOLLOW. INSTEAD, YOU NEED TO LOOK AT EACH SEPARATE ACTIVITY THEY IS CONDUCTED USING THOSE DATA. AND THEN FINALLY, WE NOTED THAT THE GRANT OF AUTHORITY SHOULD BE CLEARLY DOCUMENTED IN THE LEGAL DOCUMENT, THAT THERE COULD BE SEVERAL FORMS LIKE AN MOU, CONTRACT, PURCHASE ORDER, LETTER. BUT NOT SOMETHING SAYING WE ARE PLEASED TO WORK WITH SUCH AND SUCH UNIVERSITY. IT NEEDS TO BE MORE FORMAL THAN THAT. I'M SORRY, THIS IS WHERE WE SITE THE OCR AND CDC GUIDANCE. THIS IS THE PREAMBLE TO THE PRIVACY RULE WHERE THE OCR GAVE RECOMMENDATIONS ON THE TYPE OF DOCUMENTATION WE NEEDED FOR THIS AUTHORITY AND THEN CDC ALSO HAD SOME GUIDANCE ON THAT WE THOUGHT WAS HELPFUL. SO, I WILL OPEN UP RESPONSES OR COMMENTS ON THIS DETAILED RESPONSE TO QUESTION 1. I WILL CONSIDER IT PERFECT AND MOVE ON. >> DAVID, THIS IS LESLIE. I THINK IT'S RIGHT. I THINK IT'S INTERESTING. IT'S MORE OF A COMMENT AND NOT A REQUEST FOR ANY CHANGES. I WAS LOOKING BACK AT THIS EXCLUSION IN THE CONTEXT OF WHAT UNIVERSITIES ARE DOING NOW PREPARING FOR FALL IN THE CONTEXT OF COVID. AND THE REAL QUESTION OF COULD IT FALL WITHIN THIS AND MADE THE RELATION IT REALLY IS LIMITED TO THE PUBLIC HEALTH AUTHORITY. AND I THINK WITH THE ANALYSIS HERE, IT MAKES IT CLEAR, ALTHOUGH THERE WILL BE INSTITUTIONS AND BUSINESSES AND OTHERS WHO WILL BE DOING THE SAME KIND OF ACTIVITY IN TERMS OF TRACKING PEOPLE, TESTING PEOPLE, THAT A PUBLIC HEALTH AUTHORITY WOULD BE DOING BUT WOULD NOT FIT INTO THIS EXCLUSION. >> RIGHT. >> I THINK THE INTERPRETATION IS RIGHT AND THAT IT IS IN FACT WHAT WAS INTENDED BUT IT JUST PLAYS OUT DIFFERENTLY IN THE PLACE IN WHICH WE FIND OURSELVES IN AT THE MOMENT. >> INTERESTING COMMENT. SO I CAN SEE A UNIVERSITY LIKE WHERE MY DAUGHTER WILL BE GOING TO SCHOOL. I HOPEFULLY WILL BE DOING A GOOD JOB OF PUBLIC HEALTH SURVEILLANCE ACTIVITY. AND BUT IF THEY DON'T HAVE FEDERAL FUNDING OR SUPPORT, THEN THEY JUST DON'T FALL INTO THIS AT ALL. >> WE MAY WANT TO LEARN SOMETHING FROM IT AND I DO THINK THE INTERPRETATION IS CORRECT AND LAID OUT WELL. >> I AGREE. IT'S NICELY DESCRIBED. AND IT PERTAINS WELL BEYOND UNIVERSITY ENVIRONMENTS. WE JUST HEARD AGAIN ON THE COVID-19 THEME SOME OF THE SURVEILLANCE RESPONSIBILITIES AND ESPECIALLY CASE COUNTING THAT WERE THE RESPONSIBILITY AT THE CDC AND NOW HAVE BEEN TRANSFERRED THROUGH A CONTRACT TO A PROJECT OR PRIZE. SO SINCE THIS IS HARDLY THE UNIVERSITY ISSUE, I WOULD EXPECTS THAT THAT ENTITY WOULD FALL UNDER THE STRUCTURE THAT IS OUTLINED HERE VERY NICELY. SO I'M SUPPORTIVE, DAVID. >> GREAT. OTHERS? >> DAVID, THIS IS MARK. CAN YOU HEAR ME? >> YES. >> TO RESPOND TO LESLIE. JUST I JUST BRING THIS UP BECAUSE IT MAY INTEREST PEOPLE. ONE STRATEGY ABOUT UNIVERSITY TESTING IN ORDER TO BRING STUDENTS AND FACULTY AND OTHERS BACK ON SITE IS THAT TO THE EXTENT ONE CAN GET ESSENTIALLY A LETTER FROM THE LOCAL OR STATE PUBLIC HEALTH DEPARTMENT THAT AGREES WITH AND EVEN POSSIBLY REQUIRES THE UNIVERSITY TO DO A TESTING PROGRAM, AND ALSO THERE IS REPORTING OF THE RESULTS BACK TO THE PUBLIC HEALTH AUTHORITY. IT MAY BE POSSIBLE TO MAKE AN ARGUMENT THAT THE UNIVERSITY IS ACTING AS AN AGENT OF THE LOCAL OR STATE PUBLIC HEALTH DEPARTMENT AND THAT ALSO CAN HELP WITH THE POTENTIAL IMMUNITY UNDER THE PREP ACT. SO I JUST BRING THAT UP BECAUSE IT MAY INTEREST PEOPLE WHO ARE ON THE PHONE. >> THANK YOU. I'M GOING TO MOVE ON TO QUESTION 2. AND IF YOU ALL HAVE A SECOND CHANCE TO PROVIDE MORE COMMENTARY TOMORROW, WE HAVE THIS ON THE AGENDA. SO QUESTION TWO IS REGARDING THE OPERATION EXCLUSION WHEN IT'S NOT CARRIED OUT OR CARRIED OUT OUTSIDE OF FEDERAL, STATE OR LOCAL GOVERNMENTS. AND THE QUESTION ASKED US TO CONSIDER WHETHER THERE SHOULD BE A DIFFERENCE WHEN IT'S A CONTRACTOR VERSUS A GRANTEE VERSUS A PUBLIC-PRIVATE PARTNERSHIP THAT DOES NOT INVOLVE FUNDS. AND THE ACTIVITY MUST BE LIMITED TO ALLOW PUBLIC HEALTH AUTHORITY TO IDENTIFY, MONITOR, ET CETERA. SO AGAIN, WE STARTED THE ANSWER WITH SAYING WE NOTE THE PLAIN READING IS A DEFINITION OF A PUBLIC HEALTH AUTHORITY AND INCLUDES A PERSON OR ENTITY ACTING UNDER AUTHORITY OR CONTRACT. SO IT DOES INCLUDE PRIVATE ENTITIES WITH SUCH AUTHORITY. AND THEN WE HAD A LONG DISCUSSION AT THE SUBCOMMITTEE LEVEL ON WHETHER ONE OF THESE PRIVATE ENTITIES WITH SUCH A GRANT OF AUTHORITY OR CONTRACT COULD CONDUCT THE ENTIRE PUBLIC HEALTH SURVEILLANCE ACTIVITY THEMSELVES AND NEVER GIVE ANY INFORMATION BACK TO THE GOVERNMENT AGENCY OR THE PUBLIC HEALTH AGENCY. AND WE FELT THAT WAS WRONG. WE REALLY DIDN'T HAVE THE LANGUAGE IN THE REGULATORY LANGUAGE TO SAY IT WAS PROHIBITED BUT WE DID STATE THERE SHOULD BE SOME RETURN OF INFORMATION TO THE AGENCY AND IT COULD BE BROAD DATA. MIGHT BE REPORTS OR SUMMARIZE. BUT THAT THIS SHOULDN'T BE A MECHANISM TO COMPLETELY TAKE THE GOVERNMENT OUT OF THE PUBLIC HEALTH. IT'S FUNDAMENTALLY A GOVERNMENT ACT EVEN THOUGH THEY NEED HELP FROM PRIVATE ENTITIES, IT SHOULDN'T BE SOLELY A PRIVATE ENTITY. AND THEN WE REALLY DIDN'T HAVE MUCH TO SAY ABOUT THE DISTINCTION BETWEEN A CONTRACTOR VERSUS A GRANTEE VERSUS A PUBLIC-PRIVATE PARTNERSHIP. WE DISCUSSED THOSE AND NOBODY REALLY HAD ANY AM STRONG FEELINGS THERE WAS A DISTINCTION BETWEEN THOSE 3 IN A WAY THAT COULD BE WRITTEN OUT AT PART OF THIS RECOMMENDATION. SO I'LL OPEN IT UP TO COMMENTS AND QUESTIONS. >> DAVID, THIS IS SKIP. I GUESS A COUPLE OF COMMENTS. HAVING HAD EXPERIENCE ON THE RECEIVING END WITH NIH RELATIVE TO THE DIFFERENCES BETWEEN A CONTRACT AND A GRANT, THEY ARE SIGNIFICANTLY DIFFERENT IN TERMS OF THE OBLIGATION TO DELIVER A PRODUCT BACK TO NIH WHEREAS THE GRANT, YOU CAN PUBLISH IT AND DO WHAT YOU AND WANT JUSTIFY WHAT YOU HAVE DONE. A CONTRACT REALLY CREATES A VERY CONCONTRACTUAL RELATIONSHIP. IT APPEARS -- I THINK THERE IS AN IMPORTANT DISTINCTION THAT CAN BE CAPTURED. NOW WHETHER ALL THE OTHER AGENCIES HAVE THAT SAME DISTINCTION, I DO NOT KNOW. BUT WHAT THIS LANGUAGE APPEARS TO PRECLUDE IS - ALTHOUGH I AGREE WITH THE IDEA IF I DELEGATE MY AUTHORITY OR RESPONSIBILITY TO SOMEONE ELSE TO HANDLE SOMETHING, I SHOULD KNOW THAT THEY ARE DOING A GOOD JOB AND THEREFORE DATA SHOULD COME BACK TO ME ABOUT THAT. THE WAY THIS IS WORDED ALMOST IMPLIES, BECAUSE IT SAYS, ALLOW THE PUBLIC HEALTH AGENCY AND THEN YOU HAVE THE QUOTE, THAT I COULD NOT CREATE A CONTRACT THAT WOULD ALLOW THE CONTRACTOR TO DO THESE THINGS. IT SEEMS TO GO FURTHER THAN SAYING, IF I DECIDE TO TAKE MY PUBLIC HEALTH AUTHORITY, CREATE A CONTRACT TO A CONTRACT, THERE IS PLENTY OF GOVERNMENT CONTRACTORS THAT DO THE WORK. IT SEEMS TO PRECLUDE THAT I COULD HAVE THEM ACTUALLY ACT ON THIS, IDENTIFY MONITORS ET CETERA. AS OPPOSED GETTING THE INFORMATION BACK. IT SEEMS TO PRECLUDE MY DELEGATING THAT ACTIVITY AS OPPOSED TO JUST THEY GET OUT THE DATA AND IT COMES BACK TO ME AND I DO IT. THAT'S THE WAY I READ THIS. IT WAS INTENDED TO PRECLUDE NEVER RETURNING ANY DATA. >> I GET THAT BUT THE WAY IT IS READING OF THE TEXT, CAPTURE THAT. IT SEEMS TO GO FURTHER TO SAY IT COMES BACK SO I, AS THE AGENCY CAN DO THE WORK, NOT ALL I'M DOING IS MONITORING THE WORK OF THE CONTRACT. >> AND THANK YOU FOR THE COMMENT, SKIP. AND THEN WE DOES DISCUSS -- AND I THINK YOU'LL -- SYNONYMOUS WITH GRANT OF AUTHORITY NOT JUST THE GRANT TO CONDUCT RESEARCH. >> I REALIZE IT'S A BIT HIGHER BUT THE DISTINCTION BETWEEN GRANT AND CONTRACT WITHIN NIH. THEY CAN SPEAK TO IT. I THINK THAT IS PRETTY WELL ACCEPTED AROUND MECHANISMS OF GRANTING MONEY. I DON'T KNOW IF THAT IS TRUE OF OTHER AGENCIES. AND I THINK THAT'S A VERY GOOD PICK UP THAT SKIP MADE AND I READ IT THE SAME WAY AND JUST THINKING BACK TO DAYS AT THE CDC, IT WAS THE SAME DISTINCTION. A CONTRACT WAS JUST THAT. IT WAS AN AGREEMENT TO CONDUCT A SPECIFIED BODY OF WORK AND REPORT THAT WORK BACK TO THE FUNDING AGENCY WHEN A GRANT WAS SIGNIFICANTLY MORE PERMISSIVE IN TERMS OF THE SORTS OF WORK THAT COULD BE CONDUCTED AS PART OF THAT GRANT WITH LESS RESPONSIBILITY TO REPORTING BACK TO THE AUTHORITY. I READ IT THE SAME WAY. IT READS LINES ONE 91 TO 195T SUGGESTS THE AGENCY AND AUTHORITY CAN USE THE DATA THAT IS PROVIDED TO DO THE WORK ON IDENTIFICATION MONITORING, WHEN IN FACT, THE GRANT MAY -- THE CONTRACT MAY LOOK OR SPECIFY THAT IS THE RESPONSIBILITY OF THE RECIPIENT OF THAT CONTRACT. >> SO MAYBE AT THE SUBCOMMITTEE LEVEL, WE WENT A LITTLE FAR WITH THIS IDEA. THERE WERE A FEW SUBCOMMITTEE MEMBERS WHO FELT STRONGLY THAT THIS SHOULDN'T ALLOW A COMPLETE HANDOFF FROM THE AGENCY TO A PRIVATE ENTITY. BUT YOU ARE THE PARENT COMMITTEE. YOU DECIDE WHAT THIS SAYS. >> SO THE DEVIL IS IN THE WORD, COMPLETE. I AGREE WITH THE AGENCY SHOULD MONITOR PERFORMANCE, ABSOLUTELY. AND THE WAY TO MONITOR THAT IS TO GET THE DATA BACK AND SEE WHAT THEY ARE DOING. BUT THIS IMPLIES THAT THAT CONTRACTOR CAN EXECUTE WHATEVER >> WHERE ARE YOU SEEING, COMPLETE. >> I DON'T SEE COMPLETE EITHER. AND I WANT TO RESPOND TO SKIP AND TO WALTER. WHERE DO YOU SEE, COMPLETE, SKIP? >> DAVID USED THAT WORD BUT I LOOK AT, ALLOW THE PUBLIC HEALTH AGENCY AUTHORITY TO QUOTE, IDENTIFY. IN OTHER WORDS, I GET THE DATA BUT THEN IT COMES BACK TO ME AND I'M STILL ACTING. I IDENTIFY AND IT IMPLIES I CAN'T IN THAT CONTRACT GIVE THE CONTRACTOR THE AUTHORITY TO IDENTIFY, HONOR, ASSESS OR INVESTIGATE. THAT'S THE WAY I READ IT. >> RATHER THAN SAY COMPLETE -- SUFFICIENT. >> LET ME TELL YOU WHAT WE WERE TRYING TO SAY. THERE IS DEFINITELY A DIFFERENCE BETWEEN A GRANT AND CONTRACT IN THE SPONSORED RESEARCH WORLD AND DOD AND DOE AND OTHERS HAVE THE SAME DIFFERENCE. THE GRANT IS ONE THING AND IS HANDED OFF, MONEY HANDED OFF IN A RESEARCH PLAN AND IT'S EXECUTED BY THE INSTITUTION AND THE INVESTIGATOR, WITH ONLY ACADEMIC PUBLICATION RESULTING. WHEREAS A CONTRACT IS FOR A SPECIFIC DELIVERABLE. THAT'S TRUE. REMEMBER THAT THE CONTEXT HERE IS THAT IF IT IS THE ACTION OF A PUBLIC HEALTH AUTHORITY, EVEN IF IT IS RESEARCH, THEN THEREFORE IT IS EXEMPT FROM ALL OF THESE PROTECTIONS AND CONTROLS. SO WHAT YOU DON'T WANT TO HAPPEN AS A END RESULT IS EVERY TIME THERE IS A GRANT MADE BY NIH OR CDC OR ANYTHING ELSE, THAT THAT ALL OF A SUDDEN BECOMES EXEMPT FROM ALL IRB REVIEW AND OTHER RESEARCH REQUIREMENTS. SO THE POINT OF THE SUBCOMMITTEE HERE IS TRYING TO LIMIT THE DEFINITION OF THE RANGE OF ACTIVITY THAT WOULD HAVE COMPLETE EXEMPTION FROM THE COMMON RULE. THAT'S WHAT WE WERE TRYING TO DO. AND SO MAYBE THIS IS INARTFULLY STATED BUT WHAT WE ARE TRYING TO SAY HERE IS, IS NOT, WE ARE NOT TRYING TO SAY A PUBLIC HEALTH AUTHORITY CANNOT CUT A CONTRACT WITH AN ENTITY TO DO A PUBLIC HEALTH FUNCTION ON BEHALF OF THE AGENCY. THAT IS NOT WHAT WE ARE TRYING TO SAY. WE ABSOLUTELY BELIEVE THAT THEY CAN DO THAT AND THAT WHEN THEY DO THAT AND THERE IS A PLAN OF ACTION THAT IS DICK TAILLIGHTED BY THE PUBLIC HEALTH AUTHORITY, THE LOCAL -- DICTATED -- OR FEDERAL AUTHORITY, AND THAT CONTRACT IS DIRECTING THAT ENTITY TO DO IT, PUBLIC OR PRIVATE, THEN THAT ENTITY IS ACTING IN THE STED OF THE PUBLIC HEALTH AUTHORITY AND THEREFORE ITS ACTIVITIES WOULD BE ABLE TO TAKE ADVANTAGE OF THIS EXEMPTION. THAT'S ALL WE ARE TRYING TO SAY. I THINK YOU GUYS WERE READING TOO MUCH INTO THE WORDS HERE. >> WELL, SO MARK, WE ARE IN VIOLENT AGREEMENT. IT'S JUST THE QUESTION OF TO WHETHER IT SAYS THAT TO THE NON-LEGAL READER. AND THAT'S ALL. >> OKAY. WE'LL FECES IT. I WANTED TO LET YOU KNOW THAT'S WHAT WE WERE TRYING TO SAY. >> OKAY. I THINK WE ARE ALL AGREEING. IT JUST DIDN'T READ THAT WAY TO THE NON LEGAL READER. >> DON'T BLAME THE LAWYERS. IT MAY NOT BE A LAWYER PROBLEM. IT MIGHT JUST BE A TWO-WAY COMMUNICATION PROBLEM. >> I'M GOING TO OFFER A DIFFERENT PERSPECTIVE FROM A DIFFERENT LAWYER. AND WHEN I READ IT, I FOCUSED ON THE QUESTION A LITTLE BIT AND WHERE I THINK SOME DISTINCTION MAY BE BETTER IN THE ANSWER, WHICH SATURDAY WAY OHRP FRAMED THE QUESTION WAS THOSE ACTIVITIES CARRIED OUT BY A CONTRACTOR VERSUS A GRANTEE AND THEY SPECIFY AND I HIGHLIGHTED ON 175 TO 177, WHICH THE ACTIVITIES ARE PROPOSED BY THE GRANTEE AND NOT DIRECTED BY THE AWARDING GOVERNMENT AGENCY. SO I THINK MAKING THAT DISTINCTION, WHOSE DRIVING THE ACTIVITY? AND I THINK FOCUSING THE ANSWER ON WHO IS DRIVING THE ACTIVITY WHERE IT WOULD BE OUTSIDE OF THE COMMON RULE IF THE PUBLIC HEALTH AUTHORITY IS DRIVING THE QUESTION, THE ACTIVITY, WHAT THEY WANT CONSISTENT WITH PUBLIC HEALTH AUTHORITY VERSUS BEING A PUBLIC HEALTH ENTITY THAT GIVES OUT GRANTS AND SAYS, YOU HAVE AN INTERESTING IDEA. GO FOR IT. AND MAYBE WE'LL LEARN SOMETHING WE CAN FEED BACK IN IN SOME OTHER WAY. BUT THAT SEEMED TO BE IMPORTANT HERE. AND MAY GO BACK ALSO AS A WAY OF ADDRESSING SKIP AND WALTER'S COMMENTS ABOUT THE FACT THAT IT'S THE FUNCTION OF THE PUBLIC HEALTH AGENCY AND WHAT THEY ARE DOING FOR PUBLIC HEALTH THAT BECOMES THE IMPORTANT PART OF WHAT THAT CONTRACT IS DOING. >> WE REALLY DID POSES THAT, THAT SECOND PART OF THE QUESTION -- PASS ON THAT SECOND PART OF THE QUESTION. THANK YOU. OTHERS BEFORE WE MOVE ON TO QUESTION 3? OKAY. QUESTION 3 IS ASKING FOR MORE DEFINITION. SO WHAT ACTIVITIES SHOULD BE CONSIDERED PUBLIC HEALTH SURVEILLANCE ACTIVITY? AND THE QUESTION NOTES THAT THE TERM USED IN THE COMMON RULE BUT NOT DEFINED. AND THEN PART A OF QUESTION 3 ASKED IF WE MIGHT DEVELOP ILLUSTRATIVE CASES SUCH AS REPOSITORY AND A REPOSITORY EMBEDDED WITHIN A TRIAL. AND THEN ASK CERTAIN QUESTIONS ABOUT THE PLANNED USE OF THAT REPOSITORY. SO IN RESPONSE, WE WROTE FIRST THAT THERE HAVE BEEN DEFINITIONS PROVIDED AND THAT THE REGULATION IN ITSELF PROVIDES TWO DEFINITIONS OR TWO DESCRIPTIONS HERE. AND THEN WE NOTED THAT THE PREAMBLE ALSO HAS A LENGTHY LIST OF TESTS THAT FALL WITHIN THE DEFINITION. AND THESE ARE ALSO LISTED VERBATIM IN THE DRAFT GUIDANCE. AND WE REALLY DIDN'T HAVE ANY SUGGESTIONS TO ADD. IF WOO DO, THIS IS THE TIME TO ADD THEM. AND THEN ACTIVITIES THAT ARE NOT PUBLIC HEALTH SURVEILLANCE ACTIVITIES, WERE ALSO LISTED IN THE PREAMBLE AND THEY GAVE THESE THREE EXAMPLES OF EXPLORATORY STUDIES AND WE DIDN'T HAVE ANY SUGGESTIONS TO ADD TO THAT EITHER. SO THAT IS WHERE IT STANDS. BASICALLY WE REFERENCED THE PREAMBLE AND REGULATORY DEFINITIONS AND COMMENTS AND WE DON'T GO BEYOND THAT. AND THEN QUESTION 3A ADDRESSINGS A QUESTIO OF A REPOSITORY. THE FIRST PART LOOKS AT THE QUESTION OF A REPOSITORY THAT IS A STAND ALONE. AND IT COULD FALL WITHIN THE EXCLUSION AS LONG AS IT WAS CLEARLY FOR PUBLIC HEALTH SURVEILLANCE ACTIVITIES AND STATED THIS SHOULD BE APPLIED NARROWLY AND WE WOULD HAVE TO KNOW THE REPOSITORY ACTIVITIES WOULD FALL WITHIN THE PUBLIC HEALTH SURVEILLANCE ACTIVITY DEFINITION. NOT THAT THEY WERE UNKNOWN AT THE TIME OR MIGHT BE DONE LATER. WE SAID YOU NEED TO USE THE EXCLUSION AND NEED TO BE THE USE OF THE DATA OR SAMPLES WILL BE. HERE YOU HAVE A SEPARATE QUESTION. YOU HAVE A PROJECT THAT IS CLEARLY RESEARCH BUT THEN YOU HAVE A REPOSITORY EMBEDDED THAT IS INTENDED TO BE USED FOR PUBLIC HEALTH SURVEILLANCE ACTIVITY AND IN THE DRAFT GUIDANCE, THEY SAID THOSE ACTIVITIES THAT WERE PART OF A BIGGER PROJECT THAT MET THE PHSA EXCLUSION COULD BE CARVED OUT AND NOT GET IRB REVIEW OR FOUND TO MEET EXEMPT STATUS. SO AT THE SUBCOMMITTEE LEVEL WE AGREED WITH THAT. WE DID NOTE STARTING ON LINE 326, THAT IS DIFFERENT THAN THE TRADITIONAL VIEW WE HAD REGARDING EXEMPTIONS. THAT OHRP SAYS WHEN YOU HAVE AN EXEMPTION THAT -- IF YOU HAVE A PROJECT WITH A RESEARCH ELEMENT, YOU CAN'T CARVE OUT THE EXEMPTION AND NOT GET THEM REVIEWED. ONCE SOMETHING QUALIFIES AS RESEARCH, THE WHOLE PROJECT GETS REVIEWED. SO COMMENTS. >> THIS IS JANET. I'M LOOKING AT LINE 286. REGARDING CREATION OF REPOSITORY. IT SAYS SACHRP BELIEVES THAT IF THE SAMPLES ARE CLEARLY GOING TO BE FOR PUBLIC HEALTH SURVEILLANCE, THEN QUALIFIES FOR EXCLUSION. AND IF YOU GO DOWN TO LINE 304, IT MAKES IT SOUND LIKE SOME ELEMENTS OF IT WOULD BE RESEARCH T SEEMS CONTRADICTING. TI MESSED UP THE LINES SO I COULDN'T FOLLOW YOUR LINE NUMBERS. >> MY LINE NUMBER IS YOUR 313. SO I'M LOOKING AT THE FIRST PARAGRAPH -- I CAN'T SEE THE LINE NUMBERS. I'M LOOKING AT THE SECOND PARAGRAPH UNDER SACHRP ANSWER TO QUESTION 3A. SO THAT SAYS, IT IS CLEARLY -- REPOSITORY QUALIFIES FOR THE EXCLUSION, RIGHT? >> YES. >> OKAY. SO NOW GO BACK DOWN. >> THE QUESTION ASKS DATE AT REPOSITORIES AS A STAND-ALONE PROJECT VERSUS DATA REPOSITORY AS PART OF A BROADER CLINICAL PROJECT. THAT IS WHAT WE ARE TRYINGS TO TEASE THE DIFFERENCE OUT. >> THEY SOUND CONTRADICTORY TO ME. NOT SURE ABOUT ANYBODY ELSE. >> LET ME MAKE A NOTE. >> A COUPLE OF SUGGESTIONS. MOST OF THESE ACTIVITIES FROM PUBLIC HEALTH STANDPOINTS ARE REFERRED TO AS PASSIVE SURVEILLANCE SYSTEMS. SO FOR EXAMPLE, THE SPONTANEOUS REPORTING SYSTEM IN WHICH WE PROVIDE PATIENTS AND SUBMIT REPORTS OF ADVERSE EVENTS TO THE FDA OR TO A SPONSOR. THAT'S PASSIVE. BUT THERE ARE IMPORTANT -- ACTIVE SURVEILLANCE SYSTEMS WHICH ARE NOT -- AS FAR AS I CAN TELL CAPTURED IN ANY OF THESE BUCKETS HERE. SO A CONTRACT WITH A NUMBER OF HOSPITALS TO SPECIFICALLY PROVIDE INFORMATION IN ALL CASES OF A PARTICULAR PATHOGEN THAT THEY RECEIVE ANTIBIOTIC RESISTANT -- [ BACKGROUND NOISE ] AND SURVEILLANCE INTENDED TO MONITOR IMPACT OF MIDIGATION STRATEGY AND MOST OBVIOUS TODAY IS IMPACT OF WEARING MASK AND SOCIAL DISTANCING. >> IF YOU COULD WRITE UP THOSE NOTES AND E-MAIL THEM, THAT WOULD BE HELPFUL. >> SO THIS IS SKIP. COULD YOU GO BACK TO THE OHRP QUESTION. PART OF IT I DIDN'T THINK IT WAS NECESSARILY ANSWERED DIRECTLY. SO IF YOU START ON LINE 216 WHERE IT SAYS, FOR EXAMPLE, [ READING ] -- SO MY INTERPRETATION OF THIS CARVE OUT IS THAT THIS CARVE OUT IS DIRECTED TO THE PUBLIC HEALTH AUTHORITY OR TO A LEGITIMATE CONTRACTOR OF THE PUBLIC HEALTH AUTHORITY WHERE THAT AUTHORITY HAS IN FACT BEEN EXPLICITLY AND TRANSPARENTLY DELEGATED T DOESN'T APPLY TO PUBLISHING AN ARTICLE AND THEN SOMEBODY WHO IS DOING PUBLIC HEALTH PRACTICE, WHATEVER THAT MEANS, APPLIES THE STUDIED FINDINGS. I COUNTY SEE YOU DIRECTLY ANSWER THAT. TO ME, ONE WAY TO LIMIT THE EXTENT OF THIS CARVE OUT IS IT IS CLEARLY DIRECTED TO THE PUBLIC HEALTH AUTHORITY AND LEGITIMATE INDIVIDUALS FROM WHOM THAT AUTHORITY HAS BEEN LEGITIMATELY DELL GREATED THROUGH CONTRACT. >> SKIP, APPARENTLY YOU MISSED THE COMMENT ON THE LAST VERSION BEFORE I TURNED INTO JULIA. WE SAID WE DIDN'T ANSWER AND WE SHOULD WAIT. BUT YOU'RE RIGHT. >> IT GOES BACK TO THE QUESTION BEFORE, BASICALLY TO SAY THERE IS DEFINING PUBLIC HEALTH ACTIVITY WHICH IS IMPORTANT SO A PUBLIC HEALTH AGENCY IS THAT DOESN'T DO RESEARCH, BUT THE TWO GO TOGETHER. SO ONCE YOU HAVE DEFINED PUBLIC HEALTH SURVEILLANCE, IT DOESN'T MEAN THAT I CAN GO OUT -- IF I HAVE NO AUTHORITY AND SAY I'M DOING PUBLIC HEALTH SURVEILLANCE, EVEN IF I'M DOING THE SAME ACTIVITY THAT THE CDC WOULD DO. >> I'LL TRY TO COME UP WITH SOMETHING MORE. BECAUSE I JUST HAD A VERY DIFFICULT TIME WITH THESE TWO. >> IT GOES BACK TO THE PRIOR QUESTION. ONE COULD JUST SAY NO, THIS IS ONLY APPLYING TO PUBLIC HEALTH AUTHORITIES T DOESN'T APPLY TO THE USE OF THE DATA BY OTHER PEOPLE. >> SO THIS IS JANET. IT TIES IN. YOU HAVE A LIST OF STATEMENTS FROM THE PRE AM NEL BULLET POINTS. FOR ME IT WAS ON LINE 251. SO IT'S THE ONE THAT STARTS WITH SURVEILLANCE ACTIVITIES DESIGNED TO ENABLE THE AUTHORITY TO APPLY THE PREVALENCE OF THE KNOWN RISK FACTOR. FURTHER DOWN. >> SORRY, I'M CHANGING THINGS HERE. >> WHILE I WAS READING THIS, LOOKING FOR WAYS TO IDENTIFY PREVALENCE OF KNOWN RISK FACTOR AND THEY ARE SAYING THAT THAT IS OBVIOUSLY A PUBLIC HEALTH SURVEILLANCE ACTIVITY. IT GETS MURKY WHEN YOU'RE DEALING WITH AN AGENT YOU NEVER SEEN BEFORE. NO WAY TO MEASURE THE PREVALENCE TO START OUT WITH YET. AND THERE WERE SEVERAL DIFFERENT ORGANIZATIONS THAT CAME UP WITH WAYS FOR MEASURING WHETHER OR NOT SOMEONE HAD COVID-19 AND LATER WHETHER OR NOT SOMEONE HAD ANTIBODIES TO COVID-19. PUBLIC HEALTH MEASURES OR AGENCIES ARE MEASURING THOSE THINGS TO DETERMINE WHAT THE SPREAD OF THE VIRUS IS AND HOW MANY PEOPLE MIGHT HAVE HAD IT BUT THE PLACES BEING USED TO MEASURE WERE DEVELOPED BY IF THEY DEVELOP DEVICES AND THEY ARE BEING USED TO MEASURE BUT THEY DON'T KNOW HOW ACCURATE THEY ARE, IS THAT RESEARCH? OR PUBLIC HEALTH SURVEILLANCE? >> SO JANET, I HAVE A PROBLEM WITH MY EAR BUDS AND THEY DIED AND I SWITCHED TO ANOTHER SPEAKER SYSTEM AND I DID NOT HEAR MOST OF YOUR COMMENT. LINE 261. WE ARE DEALING WITH A NEW VIRUS. IT'S NOT LIKE WE HAVE A GOOD WAY OF KNOWING IF SOMEONE IS SICK FOR SURE. WE HAD TO DEVELOP WHETHER OR NOT SOMEONE HAD COVID-19 IN AN ACTIVE CASE AND ALSO WHETHER OR NOT THEY DEVELOPED ANTIBODIES TO SAY MAYBE THEY HAD IT IN THE PAST. RESULTS FROM THOSE TESTS ARE BEING USED IN PUBLIC HEALTH SURVEILLANCE ACTIVITIES BUT THE TESTS THEMSELVES, PART OF WHICH FALL UNDER FDA GUIDANCE, ARE RESEARCH PROJECTS. WE DON'T KNOW IF THE TESTS WORK WELL. SO THE WATER GETS REALLY MURKY. >> I AGREE WITH YOU. >> JANET, THIS IS SKIP. YOU PUT YOUR FINGER ON ONE REASON WHY I WAS GLAD THAT IT DID NOT HAVE THE DEFINITION OF RESEARCH IN THE COMMON RULE. IT'S A PUBLIC HEALTH ACTIVITY AND ALSO A CLINICAL INVESTIGATION. BUT IT'S NOT WHETHER IT DEFINES IS A DEBATABLE POINT. THEY FIND OUT AS THEY GO, WE NEED TO DO MORE RESEARCH TO FIND OUT IF THIS MEASUREMENT IS CORRECT. >> BUT ALL OF THAT IS UNDER THE FDA DIAGNOSTIC DEVICE REGULATIONS. TO APPLY THE DEFINITION OF RESEARCH TO THAT DOMAIN CREATES CONCEPTUAL PROBLEMS. AND SO -- >> THAT COMES UP IN QUESTION 8. SO WE'LL GET TO THAT. >> I THINK THERE ARE TWO ISSUES. ONE IS THE -- AND JANET POINTS THIS OUT. PREVALENCE OF KNOWN RISK FACTORS. I WOULD THINK IF ONE WERE TO SUBSTITUTE TO CHARACTERIZE RISK FACTORS, THAT WOULD BE MORE APPROPRIATE TO THE SITUATION WE HAVE BEEN IN WITH RESPECT TO SARS COVID 2. AND THEN THE ISSUE AROUND THE DEVICES AND PRECISION OF THE DEVICES -- THAT'S A DIFFERENT SEPARATE OF ISSUES WITH COMPLEXITIES. IT'S A LITTLE BIT OUTSIDE OF SURVEILLANCE BUT CRITICALLY IMPORTANT ISSUE. >> I WOULD AGREE WITH THAT. BUT STILL USING RESEARCH TO IDENTIFY WHAT THE RISK FACTORS ARE. >> AGAIN, JANET? >> I SAID, WE ARE STILL REQUIRING RESEARCH TO IDENTIFY RISK FACTORS SO THAT PUBLIC HEALTH SURVEILLANCE CAN KEEP TRACK OF THEM. FOR INSTANCE, WE STILL DON'T KNOW WHICH GROUP OF PEOPLE ARE THE ONES THAT ARE LIKELY TO BE IMPACTED WHEN THEY GET A SEVERE CASE. AND SIGNIFICANT THINGS ARE GOING ON TO DETERMINE THAT. AT THE SAME TIME THAT WE CAN SAY IT'S A PUBLIC HEALTH ACTIVITY, AND WE CAN SAY GENERALIZABLE KNOWLEDGE AND FIT THE COMMON RULE BUT IT'S UNDER FDA BUT ALSO UNDER THE FDA PART 50 AND 54. SO YOU'RE GETTING CONSENT AND IR ABANDONMENT - SO TEACH WE DON'T CALL IT RESEARCH, IT'S STILL FALLING UNDER THE FDA REGULATIONS, WHICH HAVE THE SAME PROTECTIONS. BUT IT'S NOT AS IF IN MY MIND, THIS CARVE OUT, IF WE CALLED IT PUBLIC HEALTH, WOULD ACTUALLY HAVE ANY CONSEQUENCE TO WHAT HAPPENS ON THE GROUND TO THE SUBJECT. >> I WAS MORE LOOKING AT THE STATEMENT OF THAT PARAGRAPH, THE BULLET POINT. IT SAYS THAT THESE ARE CLEARLY PART OF THE EXCLUSION. AND THEY ARE NOT. >> I KNOW. BUT THEY CAN BE EXCLUSION FROM THE COMMON RULE AND FROM HHS REGULATIONS BUT THEY ARE NOT EXCLUDED FROM FDA REGULATIONS WHICH HAVE THE SAME PROTECTION. >> OKAY. IT'S NOT ALL JUST FDA. THE RESEARCH AND RISK FACTORS ARE UNDER COMMON RULE. >> SOME OF IT IS. >> I'M GOING MOVE ON TO QUESTION 4 SO WE GET THROUGH ALL OF THE QUESTIONS. YOU LOOKED LIKE YOU WERE GOING TO SAY SOMETHING? >> NO, SORRY. >> GOOD. QUESTION 4. THIS IS VERY SHORT AND SWEET T JUST ASKED ABOUT WHAT ARE THE MEANINGS OF THESE WORDS? AND WE JUST GAVE A SHORT ANSWER HERE SAYING A PLAIN DICTIONARY DEFINITION AND SAID WE THINK THAT SUPPORTED AND REQUESTED IN PARTICULAR SHOULD BE INTERPRETED GNARLY AND THAT'S ABOUT ALL WE SAID. COMMENTS? >> 21 MORE TIME. ON THE REQUIRED IS THE SAME WITH ORDERED? IT LOOKS LIKE YOU DROPPED THE POINT I BROUGHT UP EARLIER AND FORGIVE ME IF WE THOUGHT IT WAS RESOLVED. BUT FOR ME, IT'S DIFFERENT THAN ORDERED BECAUSE ORDERED MIGHT BE SOME EXTERNAL AGENCY TOLD YOU TO DO SOMETHING WHEREAS REQUIRED MIGHT BE THE CHARTER OF AN ORGANIZATION SAYS THEY HAVE TO DO SOMETHING. [ ECHOING AUDIO ] >> SO I READ THE USE OF THESE TERMS IN THE QUESTION. AS AN ATTEMPT TO INCLUDE ANYTHING THAT PEOPLE WOULD CHARACTERIZE. SO I'M NOT SURE -- I DON'T ARGUE WITH THE DEFINITIONS. I'M NOT SURE IT'S TERRIBLY USEFUL TO PARSE THESE OUT AND THEN SAY, IT SHOULD BE LIMITED TO THIS SPECIFIC LIST [ READING ] I THINK IT'S TRYING TO BE AS EXPANSIVE AS POSSIBLE BECAUSE ALL THOSE TERMS MAY BE USED. AND I DON'T THINK IT REALLY MATTERS TERRIBLY WHICH ONE YOU USE. IT'S AT THE DIRECTION OF THE PUBLIC HEALTH AUTHORITY. I DON'T KNOW. I JUST RAISED -- NOT SURE THE QUESTION REALLY SERVES A PURPOSE PURPOSE. >> I WILL MOVE ON TO QUESTION 5 TO KEEP THINGS MOVING. THE QUESTION CENTERS ON EMERGENCY CONTEXT. AND THE PROS AND CONS OF BROAD APPLICATION OF EXCLUSION SO WHAT WE SAID WAS SHORT IN RESPONSE HERE. WE SAID THAT THE POSITIVE ALLOWING A BROAD APPLICATION OF INTERPRETATION AND EXCLUSION PROVIDES MORE FLEXIBILITY AND REDUCE ADMINISTRATIVE BURDEN WHEN IT IS FOUND TO MEET THE EXCLUSION. AND THAT THE NEGATIVE IS THAT A BROAD APPLICATION MAY HARM PUBLIC TRUST IF IT'S DONE OR APPLIED TO ACTIVITIES WHICH REALLY SHOULD HAVE IRB REVIEW AND CONSENT OR THE EXISTENCE OF THIS EXCLUSION AND WE SAID THAT YOU SHOULD BE TRANSPARENT AND HAVE A NARROW APPLICATION OUTSIDE OF THE PUBLIC HEALTH EMERGENCY AND THAT DURING A PUBLIC HEALTH EMERGENCY, A BROADER APPLICATION MAY BE APPROPRIATE IN ORDER TO ADDRESS THE ISSUES. AND CERTAINLY THIS SEEMS TO BE RELEVANT QUESTION GIVEN THE PANDEMIC. >> SO, I DON'T DISAGREE WITH WHAT YOU SAID BUT I THINK THERE IS -- MORE COULD BE SAID. PERSONALLY IT WOULD HAVE BEEN GREAT IF WE WERE PREPARED IN A NON-EMERGENCY CONTEXT TO BE ABLE TO RESPOND IN AN EMERGENCY. I DON'T HAVE ANY CONCERNS ABOUT APPLYING THIS IN A NON-EMERGENCY CONTEXT SO WE ARE PREPARED WHEN IT HAPPENS. I FIND THE ASSUMPTION, SOMEHOW IF WE ARE CARVING THIS OUT FROM RESEARCH, WE ARE NOT GETTING INFORMED CONSENT AND NO HUMAN SUBJECT PROTECTIONS. THAT'S NOT TRUE BUT THE FDA MIGHT DO OR MAY NOT BE TRUE OF WHAT OTHER AGENCIES MIGHT DO. I DON'T KNOW. BUT SOMEONE WANTED TO DO PUBLIC HEALTH SURVEILLANCE AND GET MY BLOOD, THEY HAVE TO ASK MY CONSENT TO DO THAT. IT'S NOT TRUE AT A LOCAL ASSAULT AND BATTERY LEVEL. THERE IS A NUMBER OF ASSUMPTIONS THAT NEED TO BE UNPACKED. IN ADDITION, I'M NOT SURE WHEN A NON-GOVERNMENTAL INSTITUTION CONDUCTING A PUBLIC HEALTH SURVEILLANCE ACTIVITY IS, OR BECAUSE UNLESS THEY HAVE A GRANT OF AUTHORITY FROM A PUBLIC HEALTH AUTHORITY, THEN THEY ARE NOT COVERED. SO I JUST THINK MORE NEEDS TO BE SAID. >> OKAY. OTHERS? I'M MOVING ON TO QUESTION 6. WHAT ENTITY OR INVOLVED INDIVIDUAL MAY OR SHOULD DECIDE WHETHER A PLANNED ACTIVITY MEETS THE REQUIREMENTS? AND SO WE DISCUSSED THIS AT GREAT LENGTHS AND WE THOUGHT THAT CLEARLY AS WITH EXEMPTIONS, THE INVESTIGATOR SHOULD NOT MAKE THIS DECISION. BUT WE ENDED UP COMING TO THE CONCLUSION THAT MOST OFTEN THIS EXCLUSION IS GOING TO BE APPLIED BY A GOVERNMENT AGENCY RATHER THAN BY AN INSTITUTION OR AN INDIVIDUAL AT A HOSPITAL OR UNIVERSITY-TYPE SETTING; BECAUSE IT'S GOING, GENERALLY OFTEN, WILL SPREAD ACROSS INSTITUTIONS. SO SOME OF THE SUBCOMMITTEE MEMBERS GAVE SOME REAL-LIFE EXAMPLES OF ACTIVITIES THAT HAD COME TO THEM. THERE WERE FEDERAL MONEY INVOLVED. THE ACTIVITY WAS PRESENTED TO THE INSTITUTION AS WE HAVE ALREADY DECLARED THIS TO BE A PUBLIC HEALTH SERVICE ACTIVITY UNDER THE EXCLUSION AND YOU CAN PARTICIPATE OR NOT. THE DECISION HAS BEEN MADE. SO WE TRIED TO CAPTURE THAT IDEA THAT IT SHOULD BE SOMEBODY OTHER THAN THE INVESTIGATOR. IT COULD BE AN IRB OFFICE OR SOME OTHER MECHANISM WITHIN THE INSTITUTION BUT AT TIMES IT WILL BE THE AGENCY THAT MAKES THE DECISION. COMMENTS. >> I AGREE WITH WHAT YOU SAID. I DON'T THINK WHAT IS WRITTEN HERE SAYS IT AS CLEARLY. SO JUST LOOK AT IT. AND SILD THINK IF SOMETHING CAME MY WAY I WOULD WANT TO SEE GRANT OF AUTHORITY ATTACHED AS OPPOSED -- NOT JUST -- >> AND WE TRIED TO CAPTURE IT IN LINES 388 AND 391 THERE. FOR TRANSPARENCY, THIS CRITERIA SOMEBODY PROVIDED AND SHOULD BE EASILY ACCESSIBLE. >> I GUESS I WOULD LEAD WITH ALL OF THAT. BY STARTING OFF WITH PRINCIPLE INVESTIGATOR IT FALLS INTO THE IRB EXEMPTIONS CATEGORY AND APPROACH TO THAT. I WOULD LEAD WITH THOSE IDEAS. IT IT WOULD BE CLEARER. >> THIS IS LESLIE AGAIN. I APOLOGIZE FOR CONTINUING TO TALK. I HAD ONE CONCERN AND I THINK IT'S THE PRINCIPAL INVESTIGATOR HERE, WHICH IS PUTTING IT BACK IN THE RESEARCH CONTEXT, WHICH IT IS SORT OF NOT SUPPOSED TO BE AND SORT OF LIKE THE DISCUSSION WE JUST HAD WAS ASSUMING IT IS A GRANTEE OR A CONTRACTOR RATHER THAN THE AGENCY ITSELF. WHEN I READ THIS, THIS EXCLUSION OR WHATEVER TERM WE USE FOR THIS CARVE OUT, I THINK REALLY WAS RESPONSIVE TO TRUE PUBLIC HEALTH INSTITUTIONS THAT DO THIS STUFF UNDER THEIR LEGAL AUTHORITY EVERY DAY AND FELT LIKE THEY WERE GETTING CAUGHT UP IN THE IRB REGULATION AND TRYING TO BE CLEAR ABOUT THAT. AND I THINK IT'S PROBABLY TRUE THAT WE NEED TO ADDRESS BOTH PARTS OF IT. WHAT HAPPENS WITHIN THE PUBLIC HEALTH AUTHORITY TO MAKE ITS DECISION AS WELL AS THOSE THEY MAY DEPUTIZE THROUGH WHATEVER MECHANISM THAT MAY BE AT A DIFFERENT INSTITUTION WHERE I THINK THAT ISSUE OR THE LANGUAGE ABOUT TRANSPARENCY WOULD BE REALLY IMPORTANT. BUT I THINK WE NEED TO THINK ABOUT BOTH OF THOSE AND BE CAREFUL OF THE LANGUAGE. GOING BACK TO QUESTION 3, I THINK IT'S NOT -- THE QUESTION THAT OHRP PRESENTED TALKED ABOUT PRINCIPLE STUDY AND WHEN WHAT WE ARE TALKING ABOUT IS INTENDED TO BE THIS PUBLIC HEALTH ACTIVITY THAT IS THE REASON WHY IT'S CHALLENGING TO MARK THOSE LINES. >> THAT'S A GOOD POINT. AND AS SOMEBODY WITH AN IRB BACKGROUND, I FELL RIGHT INTO IT. >> AND HERE I'M TRYING TO CHANNEL MY PUBLIC HEALTH BACKGROUND AND HAVING WALTER AROUND IN THAT. >> OTHERS? >> HI, DAVID. NOT SURE IF YOU CAN SEE MY HAND UP. I WANTED TO COMMENT THAT MAYBE WE COULD OR YOU COULD ADD SOME LANGUAGE THAT EMPHASIZES THAT I AGREE THAT SOMEONE AT THE INSTITUTION AND IT DEPENDS ON WHICH BODY THAT WOULD BE, TO MAKE THE DECISION BUT MAYBE SAY SOMETHING LIKE IN ORDER TO MAKE A DECISION REGARDING WHETHER SOMETHING IS EXCLUSIONS ARE MET -- I APOLOGIZE. THAT YOU MAY WANT TO -- MAYBE THERE ARE CERTAIN TYPES OF INFORMATION YOU MAY WANT TO RECEIVE IN ORDER TO VERIFY THAT INFORMATION. SOMETIMES IN PRACTICE, I HAD THIS HAPPEN ONCE WHERE IT HAPPENED TO BE A PERSON OR A RESEARCHER BUT IT WAS IN A NON-RESEARCH CONTEXT WHERE THEY WERE DOING SOMETHING FOR GOVERNMENT AGENCIES IN THIS SORT OF AREA AND IN TERMS OF MAKING A DECISION ABOUT WHETHER OR NOT THESE EXCLUSIONS ARE MET, WHAT KIND OF INFORMATION SHOULD I BE LOOKING AT IN ORDER TO VERIFY THAT INFORMATION? SO I THINK THAT WOULD BE HELPFUL TO ADD SOMETHING LIKE THAT AS AN EXAMPLE. AND THEN YOU ALSO SAY HERE IT MAY BE MORE PRACTICAL FOR AN AGENCY OFFICIAL TO MAKE THE DECISION. I THINK THAT IS TRUE TO HAVE THAT BE THE CASE. BUT I'M WONDERING WHAT WOULD HAPPEN IN A SITUATION WHERE YOU DO HAVE A SITUATION WHERE THE ACTIVITY -- I'M SORRY - COULD FALL INTO A RESEARCH SPHERE AND A SURVEILLANCE SPHERE. HOW DO WE NAVIGATE THAT PIECE OF IT? NOT SURE IF THAT MAKES SENSE. >> IT DOES. IT DOES. THAT WAS THE EXAMPLE THAT WAS GIVEN BY ONE OF THE SUBCOMMITTEE MEMBERS. THIS WAS PRESENTED TO HER INSTITUTION AS THE DECISION HAS BEEN MADE. TAKE IT OR LEAVE IT. AND SHE THOUGHT IT COULD HAVE BEEN RESEARCH. >> RIGHT. I THINK THAT HAPPENED IN ONE CASE WHERE I HAD A SITUATION WHERE IT WAS A LITTLE BIT VAGUE BUT I ASKED A LOT OF QUESTIONS AND I WAS ABLE TO FEEL COMFORTABLE WITH IT. BUT I JUST FEEL LIKE IT MIGHT BE GOOD TO GIVE MORE SPECIFICS EXAMPLES OF WHAT KIND OF INFORMATION. THAT WOULD BE HELPFUL. >> OKAY. >> SO DAVID, I WANTED TO CALL YOUR ATTENTION TO THE TIME. WE ARE SUPPOSED TO BE TAKING A 15 MINUTE BREAK BUT WE ARE GOING TO USE THAT TO REVIEW THE QUESTIONS FROM THE VIDEOCAST. BUT THOSE HAVE NOT BEEN TERRIBLY -- THERE HAS BEEN ONLY ONE REQUIRED A RESPONSE. SO I DON'T THINK THAT IS NECESSARY. IF THE GROUP WANTS TO CONTINUE THROUGH THE BREAK, WE ARE CLOSE TO THE END OF THE MEETING ANYWAY. SO I THINK THAT'S FINE. >> I APOLOGIZE. I THOUGHT I HAD UNTIL 4:00. >> I THINK IT'S FINE. WE'LL JUST GO TO 4:00. >> GOOD. AND THEN I HAVE TO DROP-OFF. SO IT WORKS PERFECTLY. QUESTION 7. PRETTY SHORT ANSWER. SHOULD DOCUMENTATION BE RECOMMENDED OR REQUIRED REGARDING THE DECISION POINTS? WE SAID YES, WE THINK THAT THERE SHOULD BE VERY CLEAR DOCUMENTATION AND IT SHOULD BE PUBLICLY AVAILABLE. COMMENTS? OKAY. HEARING NONE, I'LL MOVE ON. QUESTION 8, THIS IS WHERE THE ISSUE OF THE FDA COMES UP. AND SO, IT'S FUNNY BECAUSE THE QUESTION WAS WORDED SUCH THAT SINCE THIS DOESN'T APPLY TO FDA -- THERE WILL BE NO DULY REGULATED ACTIVITIES BETWEEN FDA AND OHRP AND WE DISAGREED WITH THAT RIGHT OFF AND SAID, WAIT A MINUTE. WE THINK THERE COULD BE EXAMPLES AND FOR INSTANCE IF YOU HAVE A PUBLIC HEALTH AUTHORITY USING HHS FUNDING TO CONDUCT A SURVEILLANCE PROGRAM AND THEY ARE USING DEVICES THAT FALL UNDER THE FDA REGULATION OF 21CFRA12, THEN THERE IS DUAL OVERSIGHT. WE THEN WENT ON TO NOTE THAT FDA DOES DO VARIOUS HEALTH SURVEILLANCE ACTIVITY AND BECAUSE THEY ARE AN HHS AGENCY, WHEN FDA ITSELF IS SUPPORTING OUR CONDUCTING THE RESEARCH, AS OPPOSED TO A OUTSIDE ENTITY, THAT IT CAN USE THE EXCLUSION, BUT THAT IF IS THERE A STUDY BY A PARTY OUTSIDE OF FDA UNDER 312 OR 812, THEN THE EXCLUSION DOES NOT APPLY AT THIS POINT. WE'LL SEE IF FDA ADOPTS IT IN THE FUTURE. COMMENTS? >> DAVID, THIS IS SKIP. MINOR POINT. SO LINE 417, I WOULD PUT, HOW FAR DRUG BIOLOGIC AND DEVICE REGULATIONS BECAUSE THE BIOLOGICS ARE UNDER THE SERVICE ACT AND THEN THE OTHER IS UNDER THE COSMETIC ACT. >> I KNOW. I JUST IGNORE THAT. >> I KNOW. EVERYBODY DOES. OTHERWISE IT LOOKS FINE TO ME. >> OTHERS? THANK YOU. >> TING LOOKS FINE AS WELL. >> OKAY. PERHAPS BETTER EXAMPLES TO PUT WOULD BE FAIRS OR THEIRS (?) WHICH ARE THE REPORTING SYSTEMS FOR EVENTS ASSOCIATED WITH RIGS AND BIOLOGICS. >> OKAY. -- EVENTS -- FAERS AND VAERS. THE AE STANDS FOR ADVERSE EVENTS. >> GREAT. THANK YOU. ALL RIGHT. SO THEN WE ALSO CAME UP IN THE DISCUSSIONS AT THE SUBCOMMITTEE LEVEL OF WHETHER OR NOT WE SHOULD COMMENT ON THE OHRP DRAFT GUIDANCE THAT WAS OUT ON THIS VERY QUESTION. AND OHRP SAID, SURE, GO AHEAD AND DO THAT. AND IN REVIEWING IT, EVERYONE SEEMED TO THINK IT WAS A GOOD DOCUMENT, AT LEAST NOBODY SAID IT WAS A BAD DOCUMENT. THERE WERE POINTS. SO JUST A VERY SHORT STATEMENT WE THINK IT IS GOOD AND I PUT IN TWO STATEMENTS THAT WERE PARTICULARLY NOTEWORTHY THAT I AGREED WITH. AND JUST LEFT IT AT THAT. SO VERY SHORT. SO OTHER THOUGHTS ON THAT PARTICULAR SECTION? OKAY. AND THEN WE INDIVIDUAL FIRST OF THE ALGORITHMS. SO IN THIS, IT'S A STRAIGHTFORWARD, HERE IS THE REGULATORY LANGUAGE. IF YES, MOVE ON. IF NO, IT DOESN'T MEET THE EXCLUSION. AND WE REALLY -- THE ONLY THING THAT IS NOT REGULATORY LANGUAGE IN THE CONTENT IS THIS LIST OF DEFINITIONS, BASICALLY, FROM THE DRAFT OHRP GUIDANCE, WHICH I PUT IN THERE JUST AS GIVING SOME MORE MEAT TOTALGRITHM. AND -- TOTALGRITHM. SO VERY STRAIGHTFORWARD. AND YOU WILL LOVE THIS NEXT DOCUMENT. I WILL PUT THAT UP NOW. WE HAVE STEPHEN CAME UP WITH THIS DOCUMENT AND I HAVE STARTED AT THE BOTTOM OF THE DOCUMENT WHERE YOU HAVE THE COMPLETE TREE AND THEN I'LL GO UP IN A SECOND TO SHOW YOU THE EXPLANATORY TEXT. SO THIS STARTS OFF WITH, COULD THE PROJECT BE CONSIDERED RESEARCH INVOLVING HUMAN NO. JUST STOPS UNDER THE COMMON RULE. YES, IS IT SUPPORTED BY A PUBLIC HEALTH AUTHORITY -- [ READING ] IF YES -- YOU HAVE TO APPLY STEP 3. WE HAD A LOT OF DEBATE ABOUT WHETHER STEP 1 SHOULD BE THERE. WHETHER IT JUST CONFUSED THINGS TO INCLUDE RESEARCH INVOLVING HUMAN SUBJECTS. SO TO GO UP TO THE TOP OF THE DOCUMENT, WHAT YOU'LL SEE IS THAT STEPHEN PUT TOGETHER A NICE DISCUSSION OF WHY THIS FIRST STEP SHOULD BE THERE. AND THEN SIMILARLY DISCUSSIONS AND FURTHER POINTS. SO I GUESS I WOULD LEAVE IT HERE SO PEOPLE CAN SEE THE TOTAL BUT COMMENTARY, PLEASE. >> WE HAD THIS DISCUSSION IN THE SUBCOMMITTEES BUT IT STILL STRIKES ME THAT IF SOMEONE IS CONFUSED ABOUT WHETHER SOMETHING SURVEILLANCE, THAT IF WE MAKE THAT FIRST STEP 1 BEING CONSIDERED RESEARCH, IT JUST PUTS THE PROBLEM UP THERE VERY FIRST. IT SEEMS LIKE IF WE HAVE THE FIRST LINE BEING, COULD THIS BE CONSIDERED PUBLIC HEALTH SURVEILLANCE AS A QUESTION, THEN IF THE ANSWER IS, NO, THERE IS NO REASON FOR THEM TO READ THE REST OF THE DOCUMENT. IT JUST SEEMS TO ME THAT LINE NEEDS TO BE FIRST. >> OKAY. >> SO DAVID, I CAN SPEAK TO THAT THAT. I THINK THAT -- SO THE ANSWER OF WHETHER IT CAN BE CONSIDERED LICK HEALTH SURVEILLANCE IS NOT A STRAIGHTFORWARD QUESTION. IT INVOLVES QUESTIONS 2-4T INVOLVES DOCUMENTING THE NATURE OF THE ACTIVITY, THE GRANT OF AUTHORITY, ET CETERA. STEP 1 SHOULD SORT OF BE A NO-BRAINER. SO IF YOU'RE AN INSTITUTION AND YOU GET ONE OF THE MANY ARRANGEMENTS WE HAVE TALKED ABOUT TO CONDUCT SOME ACTIVITY ON THE BASIS -- FOR THE CDC, AND IT INVOLVES -- IT DOESN'T INVOLVE INTERACTION OR INTERVENTION WITH INDIVIDUALS AND IT DOESN'T INVOLVE PERSONALLY IDENTIFIED INFORMATION. THEN DON'T WORRY ABOUT IT. THAT'S THE IDEA. THE IDEA IS TO SORT OF TAKE OFF THE LOW-HANGING FRUIT BEFORE YOU HAVE TO GET INTO THE MIRE. IF INSTEAD OF DOING THAT, YOU SAY, THIS IS COMING FROM THE CDC, ARE THEY A PUBLIC HEALTH AUTHORITY? WHAT IS THE GRANT THEY HAVE GIVEN US? HAVE WE DOCUMENTED THAT? ARE THESE ACTIVITIES SPECIFICALLY DIRECTED? IT JUST SEEMS LIKE THERE IS A BUNCH OF STUFF THAT MAY BE REQUIRED OR REQUESTED FROM PUBLIC HEALTH AUTHORITIES, INCLUDING REQUESTS FOR DEIDENTIFIED INFORMATION AND OTHER THINGS. YOU SIMPLY DON'T EVEN HAVE TO DO THIS. AND THAT'S NOT A HARDS CALL. SO THE IDEA WAS TO TAKE THE EASY STUFF OFF AND NOT FORCE PEOPLE THROUGH DIFFICULT DECISIONS IN WHAT MAY BE A MINORITY OF CASES, BUT YOU SHOULDN'T HAVE TO WORRY ABOUT THE REST OF IT. IF IT'S NOT RESEARCH, WHY ARE WE DOING THE REST OF IT? >> THAT SILENT PURPOSE, ANYWAY. I KNOW THERE IS DISAGREEMENT. >> I GUESS THE REASON IT CONFUSES ME IS IT YOU SAY COULD IT BE CONSIDERED RESEARCH? THEN YOU'RE OPENING UP THE WHOLE QUESTION AGAIN. COULD WE MAKE THAT STATEMENT A LITTLE CLEARER? LIKE DOES THIS PROJECT INVOLVE HUMAN SUBJECTS? >> SO THAT GETS TO WHAT I PUT INTO THE DISCUSSION AND THE ACTIVITIES CAN BE THE SAME BUT THE PURPOSES ARE DIFFERENT, WHICH IS DIFFICULT SOMETIMES TOO TOO. >> LET ME EXPAND ON THAT. IT WAS INTERESTING THAT WHEN YOU GAVE THE EXAMPLES OF THINGS THAT ARE JUST LOW-HANGING FRUIT, YOU DID NOT DISCUSS RESEARCH IS GENERALIZABLE KNOWLEDGE. YOU TALKED ABOUT IDENTIFIABLE LIVING HUMAN SUBJECTS, YOU TALKED ABOUT ALL THE OTHER STUFF THAT IS RELATED TO THE APPLICATION OF RESEARCH AND THE COMMON RULE. I HAVE PERSONALLY NO PROBLEM WITH THE ALGORITHM. I HAVE A PROBLEM WITH THE CONCEPTUAL DISCUSSION BEHIND THAT SIMILAR TO WHAT I RAISED IN THE OTHER DOCUMENT. I MEAN, THAT CAN BE CLEANED UP BUT BY SAYING CONSIDERED RESEARCH INVOLVING HUMAN SUBJECTS, YOU WENT AFTER THE HUMAN SUBJECT SIDE, NOT AFTER THE RESEARCH SIDE IN YOUR ANSWER TO JANET, I JUST WANT TO POINT THAT OUT. >> THAT'S THE EASY PART, RIGHT? I DON'T THINK WE NEED TO WORRY ABOUT THE GENERALIZABLE KNOWLEDGE THAT THE STEP. >> I DON'T THINK YOU -- BY GETTING INTO A DISCUSSION OF GENERALIZABILITY. SO THAT'S A WHOLE SEPARATE TOPIC. SO I HAVE NO PROBLEM WITH STARTING WITH THIS QUESTION BUT MY ISSUES ARE JUST HOW IT WAS CONCEPTUALIZED IN THE EXPLANATION. >> OKAY. I'LL LOOK AT THAT AGAIN. >> AGAIN, I DON'T THINK -- I MEAN PUBLIC SURVEILLANCE IS GENERALIZABLE KNOWLEDGE. SO IT MEETS THE DEFINITION OF RESEARCH, MOST OF IT. SO, TO SORT OF -- THE LANGUAGE IS SAYING IT'S EITHER THIS OR THAT DOESN'T HELP. IT'S RESEARCH AND THEN BUT IT'S CARVED OUT BECAUSE IT'S PUBLIC HEALTH SURVEILLANCE BY A PUBLIC HEALTH AUTHORITY. AND THAT'S THE LOGIC HERE. >> SO I THINK SKIP, WE ARE IN FUNDAMENTAL DISAGREEMENT ABOUT WHAT GENERALIZABLE KNOWLEDGE IS IN THIS CONTEXT MEANS. I THINK THAT I DON'T KNOW WE HAVE TIME. IT'S 3:59. SO WE NEED TO PICK THIS UP AND I'LL GIVE IT SOME THOUGHT. BUT I THINK THAT I'M TRYING TO STICK TO A PRACTICAL, ALL-LEARNING IS NOT RESEARCH. AND IF WE INCLUDED THAT, IF WE SAID ANYTHING YOU WANT TO LEARN IS CLASSIFIED AS RESEARCH, THEN THE ATTEMPT TO TALK ABOUT GENERALIZABLE KNOWLEDGE IS AN ATTEMPT AT LEAST, ALBEIT -- THAT'S WHY WE HAVE THE EXCLUSION IN THE FIRST PLACE OR WHATEVER YOU WANT TO CALL IT, BECAUSE THAT CASTS SUCH A WIDE NET THAT IT CAPTURED THINGS AND THAT'S IT I THINK. >> THANK YOU. [ MULTIPLE SPEAKERS ] >> AND I WILL LOOK MORE CLOSELY AT THE DISCUSSION. I'LL TRY TO LOOK AT THE DISCUSSION OF THE FLOWCHART AND SEE IF I CAN MAKE IT -- BUT NOW WE ARE ENTERING THE PUBLIC COMMENT PERIOD. LET ME PULL UP MY AGENDA HERE. ADDRESS THAT IS ON THE VIDEOCAST. AND I HAVE BEEN MONITORING THOSE E-MAILS AND THERE WERE A NUMBER, A TOTAL OF SEVEN COMMENTS. MANY AT THE BEGINNING WERE RELATED TO THE QUALITY OF CONNECTION, THE PRESENCE OF STATIC AND NOISE, ET CETERA. THE ONLY QUESTION THAT WAS MADE OR SUBSTANTIVE RELATED TO THE DDIR DISCUSSION, AND THE PARTICIPANT ASKED, I'M SORRY IF I MISSED THIS, BUT DOES THIS DOCUMENT -- REMEMBER THE DDIR DOCUMENT -- COVER PRIOR CONCEPT OR ETHICAL CONSIDERATIONS FROM THE DECEASED INDIVIDUAL'S PERSPECTIVE? I WOULD ADD, OBVIOUSLY THE FAMILY OF THE DECEASED. AND THE ANSWER IS, NO. THAT THAT WAS NOT CONSIDERED IN SCOPE. THIS WAS SPECIFICALLY A SET OF QUESTIONS UNDER THE COMMON RULE FOR RESEARCH INVOLVING HUMAN SUBJECTS. THE MANIPULATION OF THE ORGANS FROM THE DECEASED INDIVIUAL DOES NOT FALL UNDER THE COMMON RULE IF THAT INDIVIDUAL IS DEAD. SO THAT'S NOT TO MINIMIZE OR DISMISS THAT CONCERN. IT'S A VERY SIGNIFICANT CONCERN. I BELIEVE IT IS ADDRESSED IN THE REPORT AND THERE ARE CLEARLY ETHICAL OBLIGATIONS AND I BELIEVE ARE WELL DISCHARGED IN THE STUDIES THAT HVE BEEN DONE TO DATE. BUT THEY ARE NOT WITHIN SCOPE OF THE DOCUMENT. DOES ANYONE HAVE A DIFFERENT RESPONSE FOR THAT QUESTION THAT THEY WOULD LIKE TO SHARE? ALL RIGHT. HOPEFULLY THAT SATISFIES THE INDIVIDUAL WHO ASKED. AND I'M GOING TO GO, SINCE WE HAVE ADDITIONAL TIME NOW, I'M GOING ASK MARK TO BRING BACK HIS DOCUMENT AND TRY TO GET CLOSURE. I'M NOT GOING TO HAVE A CHANCE TO MAKE THE CHANGES TO THE DDIR DOCUMENT. HOPEFULLY WE'LL HAVE TIME TO DEAL WITH THAT TOMORROW. MARK? >> DR. BARNES: CAN ONE OF YOU PULL UP -- YOU CAN -- YOU SENT IT TO EVERYONE BUT THERE MAY BE PENAL ON THE WEBCAST WHO WOULD LIKE TO SEE THE RED LINED DOCUMENT. I WAS BORN TO TYPE SO I JUST WENT AHEAD AND DID IT. >> GREAT. VERY MUCH APPRECIATE THAT. >> I HAVE IT UP, DO YOU WANT ME TO SHARE IT, STEPHEN? >> SURE. >> IF NOT, I CAN DO IT. >> THERE WE GO. >> SO I TRIED TO TAKE INTO ACCOUNT ALL THE NOTES THAT PEOPLE SAID AND HOPING THAT THAT WAS EVERYTHING THAT WAS VOICED. THIS RESULTS IN A BIT OF LANGUAGE. AND THAT'S OKAY BECAUSE IT WAS NOT MEANT TO BE ENTERTAINING AS A NOVEL. SO IF YOU GO TO LINE 41 AND 42 -- >> THERE IS 40 RIGHT THERE AND THEN 41 AND 42 IS RIGHT THERE. EVERYBODY SEEING IT? >> THE GOVERNED WAS STEPHEN'S POINT INSTEAD OF DICTATED. AND WHAT MAKES IT CLEAR ON 41 IS THAT THE PLANS OF THE INVESTIGATORS HAVE TO TAKE INTO ACCOUNT THE RESTRICTIONS OF ALL OF THESE OTHER REGULATIONS AND LEGAL REQUIREMENTS LINE 43, PLANS MUST INCLUDE CONSIDERATION OF THESE REQUIREMENTS WHICH SACHRP RECOGNIZES MIGHT OFTEN BE UNKNOWN IN DATA PRIVACY LAW. THAT IS TO WHAT LESLIE WOLF SUGGESTED BUT HOW THIS WAS A BIG DEAL OF WHICH INVESTIGATORS MIGHT NOT BE AWARE. LESLIE'S POINT ALSO ON LINE 77, WHICH IS THAT -- [ READING ] I SEGREGATED THIS ON LINE 77-84 SO THAT LESLIE, IT COVERED CONSENT BEING DRAFTED NOW, LOOKING AT CONSENTS DRAFTED IN THE PAST THAT MIGHT CONTAIN RESTRICTIONS AND THEN ENSURING COMPLIANCE WITH THOSE DATA LIMITATIONS IN THESE INVESTIGATORS OWN DATA SHARING DOWN THE LINE. SO THAT'S DONE. THERE IS A NEW FOOTNOTE, 8, WHICH DEFINES IDENTIFICATION AND ANONYMIZATION AND SENSITIVE DATA. DEIDENTIFICATION AS THE HIPPA DEFINITION, ANONYMIZATION USING THE STANDARD IN THE COMMON RULE OF READILY IDENTIFIABLE -- NOT READILY IDENTIFIABLE, AND SENSITIVE DATA REFERRING TO PERSONAL DATA WHOSE DISCLOSIER CAN BE EXPECTED TO BRING IDENTIFIABLE INJURY OR HARM TO THE DATA SUBJECT -- [ READING ] SO THAT WAS RESPONSE, I THINK, TO MAYBE LINDA'S POINT. STEPHEN'S POINT ON LINE 110. UPON STEPHEN WAS CONFUSED ABOUT WHY WE WOULD WORRY ABOUT STANDARD OF CARE CONSENTS OR NOTICES OF PRIVACY PRACTICES. SO I TRIED TO SAY IN LINES 109-111, THAT PATIENT SHOULD BE AWARE OF DATA SHARED FOR FUTURE RESEARCH EVEN IN ADVANCE OF ANY PARTICIPATION IN A PRIMARY RESEARCH STUDY AS MANY DATA USED IN PRIMARY STUDIES ARE PREVIOUSLY GAINED DURING DELIVERY OF STANDARD CARE OR PREVIOUS RESEARCH. WALTER MADE A POINT ABOUT HEALTH LITERACY ENCOMPASSED IN THE ADDITION ON LINE 116. THESE TEMPLATES BE CRAFTED TO RESPECT HEALTH LITERACY LIMITATION THAT IS CHARACTERIZE THE PUBLIC AT LARGE. I TRIED TO SAY THAT IN A NON PEJORATIVE WAY. I DON'T HAVE EXACTLY THE LINE BUT AS SEVERAL POINTS IN HERE -- I TOOK OUT THE WORD BROAD. THE WORD BROAD CONSENT, BROAD REGULATORY CONSENT NEVER APPEARED. BROAD DATA SHARING APPEARED SO I HAVE TAKEN OUT THE WORD BROAD FROM THE NIH ABOUT THE CONFUSION THAT BROAD DATA SHARING MIGHT HAVE WITH BROAD CONSENT. >> SO THERE IS STILL THE WORD, BROAD ON LINE 91. >> OKAY. YOU CAN REGARD THAT AS TAKEN OUT OUT. OKAY? FOR THIS PURPOSE. NOW THE NEXT IS -- I'M SKIPPING OVER THE RECOMMENDS. >> THAT'S FINE. >> I THINK THE NEXT SIGNIFICANT CHANGE -- IF YOU LOOK ON LINE 1 192, THIS IS IN RESPONSE TO CONSUELO'S POINT ASKING ABOUT WHAT ARE WE TALKING ABOUT HERE? FOR EXAMPLE INDIVIDUALS BELONGING TO -- [ READING ] I'M TRYING TO MAKE IT CLEARER THROUGH THE EXAMPLES OF WHAT WE MIGHT BE TALKING ABOUT HERE. AND THEN SMALLER ON DOWN FURTHER, DOE FIND VULNERABLE POPULATIONS. -- DEFINED. ANDIC LINDA A POINT ON 301, THE GDPR AND OTHER NATIONAL PRIVACY LAWS OUTSIDE OF THE UNITED STATES MAY USE THESE TERMS DEIDENTIFICATION, WHICH IS MISSPELLED BUT I WILL SPELL IT CORRECTLY AND ANONYMIZE, THEY MAY USE THOSE TERMS IN DIFFERENT WAYS -- [ READING ] WE NEED TO BE CAREFUL ABOUT KNOWING ABOUT THESE U.S. LAWS AND HOW THEY MIGHT APPLY AND NOT ASSUMING THAT THE TERMINOLOGY IN THOSE LAWS WILL BE THE SAME. THAT'S WHAT I DID. I TRIED TO GET EVERYTHING THAT PEOPLE HAD SAID. >> I THINK YOU DID A GOOD JOB, PERSONALLY. >> THANK YOU. ANY COMMENTS? >> MARK, THE EDITS LOOK GREAT. CAN WE JUST RETURN TO A POINT YOU MADE EARLIER THIS MORNING REGARDING POTENTIAL PENALTIES. AND I'M WONDERING WHETHER IT WOULD BE WITHIN THE PER VIEW OF THE COMMITTEE TO MAKE RECOMMENDATIONS ON DIGS CLOSURE OF DATA OUTSIDE OF THE -- DISCLOSURE -- STIPULATED IN THE DRAFT POLICY, PENALTIES FOR SELLING DATA FOR COMMERCIAL USE. WHICH IS FAR OUTSIDE OF THE INFORMED CONSENT THAT WE WOULD AGREE TO AND YOU POINTED OUT THERE HAS BEEN A WIDELY RECOGNIZED CHALLENGE IN CONTEMPORARY SOCIETY ONE WHICH WILL HAS BEEN SOME RESISTANCE TO TRYING TO PUSH FORWARD AND HOLD THOSE ORGANIZATIONS ACCOUNTABLE FOR SUCH INAPPROPRIATE USE OF DATA. AND WONDER WHETHER IF YOU HAVE GIVEN THOUGHT TO WHETHER IT WOULD BE WITHIN THE REMIT OF THE COMMITTEE TO MAKE A RECOMMENDATION FOR THERE TO BE PENALTIES IN THIS MANNER. >> WELL, WALTER, IF YOU LOOK AT THE RECOMMENDATION I THINK IT IS AT A LEVEL OF GENERALITY THAT MAY NOT BE SUFFICIENT FOR WHAT YOU'RE TALKING ABOUT BUT ON LINES TWLINES 277-289. I INTENTIONALLY LEFT IN THE WORD, BELIEVE, IT WAS JUST A BACKGROUND THOUGHT, SKIP, IN LINE 279. WE SAY SACHRP RECOMMENDS THAT NIH ARTICULATE STRONGER MEASURES TO DETERMORE EFFECTIVELY ANY MISUSE OF SUCH DATA -- [ READING ] WHAT I WOULD SAY, WALTER, IS THAT IF YOU ARE INTERESTED IN THAT ISSUE, I THINK THAT WE CAN TAKE THAT UP, THAT ISSUE UP BY ITSELF. THIS IS PROBABLY SUFFICIENT FOR THE PURPOSE OF RESPONDING TO THE NIH BUT WHAT WE ARE TALKING ABOUT IS AN ISSUE THAT HAS BOTH PRIVACY IMPLICATIONS AS WELL AS HUMAN SUBJECTS RESEARCH IMPLICATIONS AND IT'S ALL ABOUT PROTECTING THE WELFARE OF RESEARCH SUBJECTS. SUBCOMMITTEE, IF TOLD BY YOU GUYS AND JERRY AND THE LEADERSHIP, WE ARE HAPPY TO TAKE THAT UP AS A DISCRETE TOPIC. >> SO I WOULD BE SUPPORTIVE OF FURTHER DISCUSSION ON THIS TOPIC AND WONDER WHAT OTHERS THINK AS WELL. >> WALTER, THIS IS SKIP. DO YOU REALLY THINK WE SHOULD GET INTO THE DETAILS ABOUT GEE, IT SHOULD BE THIS AMOUNT OF MONEY FOR THIS OR THAT? I MEAN, THIS LOOKS PRETTY STRONG. THERE SHOULD BE SANCTIONS OF SIGNIFICANT CONSEQUENCE AND SUGGESTED ENFORCEMENT MECHANISMS OR FINES OR CIVIL MONETARY PENALTIES. I DON'T KNOW IF WE WANT TO GET INTO HOW BIG AND HOW MUCH, DO WE? >> I DON'T MEAN TO BE -- I DON'T THINK WE CAN OR SHOULD BE TERRIBLY DESCRIPTIVE BUT I WOULD JUST DIFFERENTIATE THAT WHAT IS A SUBSTANTIVE PENALTY TO INVESTIGATOR IS QUITE DIFFERENT THAN IT IS TO A LARGE CORPORATION. AND PERHAPS THERE ARE SEVERAL LAWYERS ON THE COMMITTEE AND THEY MAY SUGGEST THAT THIS VERBIAGE IS SUFFICIENTLY DIRECTIVE, THAT IT WILL BE UNDERSTOOD BUT I SIMPLY WANTED TO CALL OUT THAT I THINK THIS IS AN IMPORTANT ISSUE THAT MERITS ATTENTION. >> SO HOW DO PEOPLE FEEL ABOUT ADDRESSING THAT? I'M AMBIVALENT BECAUSE I THINK THIS IS AN IMPORTANT DOCUMENT TO GET OUT. AND I THINK WALTER, THAT THE ISSUE YOU RAISE IS LITERALLY MUCH LARGER. AND IT EXTENDS TO DATA SHARING AND DATA USE ACROSS-THE-BOARD. >> STEPHEN, MY VIEW IS THAT THE DOCUMENT IS STRONG ENOUGH AND IF THIS RECOMMENDATION IS ACTED ON, I ASSUME THE PEOPLE THAT WILL CREATE THE STRUCTURE AROUND IT WOULD RECOGNIZE THE IMPORTANT DIFFERENCES BETWEEN AN INVESTIGATOR WITH A SMALL INSTITUTION VERSUS A CORPORATE ENTITY. I MEAN IN RECOGNIZING THEY CAN'T BE THE SAME. BUT I DON'T KNOW. I WOULDN'T HAVE THE EXPERTISE TO START SAYING WHAT THAT OUGHT TO LOOK LIKE. >> NO, NO. AND I AGREE WITH YOU. THE QUESTION IS -- I WAS JUST POINTING OUT AND I'M HAPPY WITH THE DOCUMENT AND I WAS JUST POINTING OUT THAT THIS IS PERHAPS A BROADER TOPIC, THAT SANCTIONS FOR DATA MISUSE GOALS WELL BEYOND NIH DATA SHARING. [ MULTIPLE SPEAKERS ] >> IS I'M VERY SUPPORTIVE OF GETTING THIS DOCUMENT OUT AND I THINK FOR THE PURPOSES OF -- THIS MAY WELL BE SUFFICIENT FOR THIS DOCUMENT BUT I RAISED THE BROADER ISSUE AS ONE THAT MAY MERIT DISCUSSION IN A DIFFERENT SACHRP MEETING. >> THANK YOU, WALTER. >> THIS IS LESLIE. I HAD ONE -- I WANT TO SAY MARK, YOU'RE BRILLIANT. YOU ADDRESSED ALL THESE THINGS ON THE FLY. I HAVE ONE MINOR KNIT IN FOOTNOTE 8. SENSITIVE DATA. IT'S IDENTIFIABLE REPUTATIONAL INJURY OR HARM. AND I THINK IT CAN BE, OTHER TYPES OF INJURY. I WOULD TAKE OUT REPUTATIONAL AND I THINK YOU DEFINED IT WONDERFULLY. JUST SO IT COULD BE BROADER. >> THAT IS FINE. I DID NOT MEAN REPUTATIONAL TO MODIFY HARM THERE BUT I CAN TAKE THAT OUT. I JUST MEANT ANY HARM. BUT I CAN TAKE OUT REPUTATIONAL, THAT'S FINE. >> ANY LAST CHANGES? I WOULD ENTER TAIN A MOTION TO ENDORSE THE RECOMMENDATION AS MODIFIED. -- ENTERTAIN. >> SO MOVED. >> SECOND. >> MOVED AND SECONDED. ALL IN FAVOR SAY, YEA. AND VERY IMPORTANTLY, ALL OPPOSED SAY NEIGH. AND ANY ABSTENTIONS. THE RECOMMENDATION IS PASSED. THANK YOU, MARK. >> NO PROBLEM. SO I WILL DO THE LAST LITTLE THINGS THAT WERE TALKED ABOUT AND I WILL SEND JULIA A CLEAN COPY, OKAY? >> THANK YOU VERY MUCH. AND BEFORE WE MOVE TO THE CLOSING OF BUSINESS, WE DID HAVE ONE MORE VIDEOCAST QUESTION -- WALTER CAN I ASK YOU TO MUTE? THANK YOU. I ASSUME YOU NO LONGER SEE MY SCREEN? >> WE NO LONGER SEE YOUR SCREEN. >> JUST CHECKING. >> THANK YOU FOR STEPPING IN AND SHARING THAT. >> NO PROBLEM. >> WE HAVE ONE MORE QUESTION THAT CAME IN FROM THE VIDEOCAST PARTICIPANTS. IT SAYS, GOOD AFTERNOON, THANK YOU FOR THIS. WILL THE RED LINES IN THE DOCUMENTS BE MADE AVAILABLE FOR PARTICIPANTS THIS EVENING OR EARLY TOMORROW MORNING? I'LL TURN TO JULIA TO ANSWER THAT. JULIA, YOU'RE MUTED. >> THANK YOU. I COULDN'T GET MY CURSOR OVER. I'LL BE POSTING THE FINAL RECOMMENDATIONS AND POTENTIALLY APPROVED RECOMMENDATIONS AFTER TOMORROW. THERE IS A SLIGHT DELAY BETWEEN THE TIME THEY ARE POSTED AND THE TIME IT'S ON THE DOCKET. IF THERE IS A PARTICULAR VIEWER WHO IS URGENTLY WANTING OR NEEDING A PARTICULAR DOCUMENT, I WOULD ENCOURAGE THEM TO E-MAIL ME NOW OR VERY SHORTLY IF YOU'RE LOOKING FOR DOCUMENTS FROM TODAY. I WILL TRY MY BEST TO GET THEM OUT TO YOU. AND MY E-MAIL ADDRESS IS JULIA GOREY AT HHS.GOV. >> JULIA, DO WE HAVE ANY OTHER CLOSING BUSINESS? >> NO, WE DO NOT. >> ALL RIGHT. ING, THANK YOU ALL NEW SACHRP MEMBERS AND PARTICIPANTS. THANK YOU TO EVERYONE THROUGH THE PUBLIC WHO SAT THROUGH THE VIDEOCAST AND WE'LL SEE MANY OF YOU OR MOST OF YOU ALL AGAIN TOMORROW MORNING. >> 10:30. >> AT 10:30. >> THE CONNECTIVITY BEFORE THE MEETING OPENS AT 11, YES, THANK YOU. >> SO THAT'S NOT FOR PEOPLE ON THE VIDEOCAST. >> NO. >> WE ARE LIVE AT 11:00. I WILL DECLARE THE MEETING ADJOURNED UNTIL TOMORROW MORNING. >> THANK YOU ALL VERY MUCH!