>> WE HAVE A BUSY DAY AND BEFORE WE GO THROUGH THE ROLL CALLS AND ALL THE OTHER PIECES OF THIS, LET'S GET THE TECHNICAL ISSUES OUT OF THE WAY. JULIA DO YOU WANT TO TELL ANYONE ABOUT TECHNICAL THINGS. >> WELL LET ME FIRST OF ALL TELL ANY MEMBERS OF THE PUBLIC HOW TO ACCESS THE MATERIALS FOR THE MEETING. YOU WANT TO GO TO REGULATIONS.GOV. WITH ALL THE MATERIALS, CAN YOU GO TO REGULATIONS.GOV AND YOU CAN SEARCH HHS-OPHS-2020-0005. IF THAT'S WHAT YOU WANT TO DO, BUT IT WOULD B SIMPLER TO GO TO REGULATIONS.GOV, GO TO THE DOCKET AND SEARCH SACHRP OCTOBER. AND THERE WILL BE A DOCUMENT WITH ALL THE PUBLIC MATERIALS. >> THANK YOU. >> THANK YOU. , AND ONCE WE GET TO COMMITTEE DISCUSSION WHAT I WOULD LIKE PEOPLE TO DO IS USE THE RAISE HAND FEATURE WHICH I THINK YOU JUST HOVER OWEVER YORE NAME AND THE PARTICIPANT LIST AND YOU HAVE A LITTLE ICON WITH A HAND THAT COMES UP IN THOSE CIRCUMSTANCES AND THOSE ACTUALLY THEP APPEAR ON MY SCREEN, GET SORTED TO THE TOP AND I THINK THAT'S THE BEST WAY. I WOULD NOT USE THE CHAT PRIMARILY. I'M NOT SURE WHO IS GOING TO BE MONITORING THAT. I'LL TRY TO KEEP AN EYE ON IT. I'M SURE JULIA WILL AS WELL BUT I WOULD PREFER TO KEEP IT AS MEETING LIKE AS POSSIBLE. THERE IS ALSO A MECHANISM FOR THE PUBLIC TO SEND IN COMMENTS. AND SO WHEN WE GET TO THE PUBLIC COMMENT PERIOD, I'LL EXERT THOSE AND REVIEW THEM AS WE RECEIVE IT. DOES ANYONE ELSE HAVE TECHNICAL QUESTIONS OR ISSUES BEFORE WE GET STARTED. OKAY, GREAT. I WILL START WITH ROLL CALL, WHEN I CALL YOUR NAME, JUST BRIEFLY INTRODUCE YOURSELF, PARTICULARLY FOR MEMBERS OF THE PUBLIC WHO ARE WATCHING TODAY. SO I WILL GO DOWN THE ROSTER, I WILL START WITH MARY ELEN ALLAN? ARE YOU THERE? I SAW YOU EARLIER. ALL RIGHT, WE'RE COME BACK TO MARY ELLEN. >> JODI? >> HI, GOOD MORNING I'M JOE I'M DIRECTOR FOR [INDISCERNIBLE] RESEARCH WITH THE [INDISCERNIBLE] RESEARCH INSTITUTE IN SOUTH DAKOTA, I'VE BEEN A MEMBER FOR THE PAST YEAR AND HAVE HAD MY EXPERIENCE HAS BEEN IN WORKING WITH A LOT OF NATIVE COMMUNITIES IN THE REGION AND HELPING WITH DEVELOPING THE REGULATORY PROCESSES. >> IS LINDA COLEMAN ON? I'LL COME BACK TO LINDA. DOUG [INDISCERNIBLE]. >> GOOD MORNING. I'M DOUG [INDISCERNIBLE], I AM AT THE UNIVERSITY OF WASHINGTON WHERE AMOUNT OF EXPERIENCE A PROFESSOR OF PEDIATRICS IN SEATTLE CHILDREN'S HOSPITAL WHERE I AM THE DIRECTOR OF EDUCATION AT THE [INDISCERNIBLE] CENTER FOR PEDIATRIC BIOETHICS AND THIS IS MY FIRST YEAR ON SACHRP. >> JANET DAILY? >> HI I'M JANET [INDISCERNIBLE] I'M AN ADVOCATE FOR CANCER, I HAVE LUNG CANCER AND I'M ALSO THE CO FACTOR OF CANNED WHAT WITH A SPECIAL CANCER. >> STEVEN I'M HEARING-- >> JANET--SORRY. >> HEARING BACKGROUND NOISE. >> YEAH. >> WHAT KIND OF--CAN YOU DESCRIBE THEM BRIEFLY SO WE CAN SORT OF TARGET? >> I DON'T KNOW SOMEBODY SOMEBODY'S FAN IN THE BACKGROUND OR RUSTLING SOMETHING AROUND. >> IF EVERYONE COULD KEEP THEMSELVES ON MUTE WHEN THEY'RE NOT SPEAKING AND STEVEN UNFORTUNATELY THAT MEANS YOU TOO. >> UNDERSTOOD, I HAVE A HARD DRIVE THAT WAS BACKING UP IF THAT WAS THE CAUSE, I'VE TURNED IT OFF SO WE'LL SEE. THANK YOU FOR TELLING US JANET, IF IT COMES UP AGAIN FEEL FREE TO CALL THAT OUT. SKIP NELSON? >> THANKS STEVEN, SKIP NELSON, SENIOR DIRECTOR OF PEDIATRIC DEVELOPMENT AT JOHNSON & JOHNSON. >> THANK YOU. WALTER STRAUSS. >> --STARE, AUIS, S, VICE PRESIDENT OF THERAPEUTICS FOR CLINICAL SAFETY AND MISMANAGEMENT AT [INDISCERNIBLE] DEVELOPS AND XECIALIZES VACCINES AND THERAPEUTIC PRODUCTS, CLINICIAN AT-- >> I'M THE VICE PRESIDENT FOR HEALTH EQUITY AT VANDERBILT, I'M AN INTERNIST AND GERIATRICIAN, VERY INVOLVED IN OUR CLINICAL AND DRANSALATION SCIENCES AWARD. >> THANK YOU. KEVIN WEINSTEIN. >> KEVIN, PROFESSOR AND VICE CHAIR OF RESEARCH AT THE DEPARTMENT OF POPULATION HEALTH SCIENCES AT DUKE UNIVERSITY. >> LESLIE WOLF? >> INTERIM DEAN AND PROFESSOR AT GEORGIAITATE UNIVERSITY COLLEGE OF LAW. NTHANK YOU. AND I THINK THAT COMPLETES THE SACHRP OTHER THAN ME, STEVEN ROSENFELLED, I'M THE CHAIR AT THE MEMORY CLONE I'M AN INDEPENDENT CHAIR, PHYSICIAN AND CONSULTANT. WOULD PEOPLE FROM OHRP IDENTIFY THEMSELVES. >> THIS IS JERRY MENIKOFF, OHRP DIRECTOR. >> JULIA [INDISCERNIBLE] OHRP. >> HI, JULIE [INDISCERNIBLE] OHRP. >> --OHRP. >> ANYONE ELSE? >> [INDISCERNIBLE] HERNçNDEZ OHRP. >> THANK YOU. AND JULIA DO YOU WANT TO DO EXOFFICIOS OR NOT? >> I ASKED THE EXOFFICIOS WHO ARE ON TO PLEASE IDENTIFY THEMSELVES. PERHAPS STARTING WITH NIH? >> MIA KLEIN, ACTING TEAM LEAD IN THE OFFICE OF SCIENCE POLICY AT NIH. >> [INDISCERNIBLE] THE DIRECTOR OF DIVISION OF CLINICAL HEALTHCARE RESEARCH POLICY. >> [INDISCERNIBLE] FDA. >> FDA. >> GOOD MORNING HI, THAT IS KEVIN [INDISCERNIBLE] FROM THE OFFICE OF CLINICAL PRACTICE FDA. >> ANY RPGHT EXOFFICIOS, PLEASE? >> THIS IS [INDISCERNIBLE] FROM HRQ. >> THANK YOU. [SPEAKING AT SAME TIME ] >> THIS IS ELISE, ANTHONY NATIONAL OFFICE FOR COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY SITTING IN FOR [INDISCERNIBLE]. >> THANK YOU. >> [INDISCERNIBLE] WITH THE CENTERS FOR DISEASE CONTROL AND PREVENTION, OFFICE OF SCIENCE. >> THIS IS PAYTON ISAAC SITTING IN FOR [INDISCERNIBLE] OFFICE FOR CIVIL RIGHTS. >> I DO SEE THAT LINDA COLEMAN HAS JOINED US. WE JUST GO THE ROSTER CAN YOU DO A BRIEF INTRODUCTION? >> THANK YOU. THANK YOU FOR YOUR PATIENCE THIS MORNING, I HAD TO HAVE IT HELP ME GET ACCESS. MY NAME IS LINDA COLE MAN, I'M DIRECTOR OF THE HUMAN RESEARCH PROTECTION PROGRAM AT YALE UNIVERSITY. AND SO I'VE BEEN AT YALE FOR CLOSE TO 5 YEARS AND PRIOR TO THAT, I WORKED AT AN EXTERNAL IRB QUORUM REVIEW WHICH IS NOW [INDISCERNIBLE] FOR 8 YEARS AND BEFORE THAT I WAS IN PRIVATE PRACTICE, PRACTICING HEALTH LAW. THAT'S MY BACKGROUND. SO GOOD MORNING EVERYONE. >> MORNING. >> AND IS MARY ELLENOIR BACK? >> YES, I AM. I AM UNMUTED NOW. HELLO EVERYONE. MARY ELLEN, ALLEN, ASSISTANT COUNSEL OF GENENTEH IN IS SAN FRANCISCO, I SUPPORT OUR BIOETHICS GROUP, RESEARCH AND CLINICAL DEVELOPMENT PROGRAMS AND PERSONALIZED HEALTHCARE INITIATIVES. >> ANY OTHER ANNOUNCEMENTS OR TECHNICALITYS BEFORE WE GET STARTED NNO. >> OKAY, WELL I WOULD LIKE YOU ALL--THANK YOU FOR FOR JOINING US FOR THE MEETING TODAY, I KNOW IT WAS SHORTENED BUT THAT PUTS--IT MAKES FOR A VERY BUSY SINGLE DAY. I WAS REALLY STRUCK YOU KNOW SACHRP OFTEN DEALS WITH ISSUES OF REGULATORY INTERPRETATION, NEARBY APPLICATIONS WAS REGS THAT ARE LIKELY OBSCURED TO MANY, BUT THE LIST OF TOPICS FOR TODAY OFFERS REALLY A DRAMATIC CONTRAST AND I CAN'T REMEMBER A MEETING WHEN OUR TOPICS WERE SUCH--MONTHS AMONG THEM THE PUBLIC HEALTH SURVEILLANCE TOPIC WAS MADE EXPLICIT IN THE 2018 [INDISCERNIBLE] IT SEEMED QUITE STRAIGHT FORWARD REALLY UNTIL WE ALL HAD TO COMPLY TO IT EVERY DAY. SIMILARLY NONAPOPTOTIC TERMS OF RISK TO NONPARTICIPANTS, THERE'S NOTHING THROUGH IN THE IDEA THAT RESEARCH IMPOSED RISKS BEYOND THOSE WE ASK EXPLICIT PARTICIPANTS TO BEAR. BUT SUCH CONCERNS REALLY BECAME URGENT AND WIDE SPREAD IN THE CONTEXT OF RESEARCH ON COVID-19 AND VACCINES. AND I THINK LASTLY JUSTICE IS OBVIOUSLY ANYTHING BUT A NEW ISSUE. AND YOU KNOW JUST AS IT TOOK EGREGIOUS HARMS THROUGH TUSKEGEE TO SPUR EGHT ICS AND THE DEVELOPMENT OF BELMONT AND THE REGS, I THINK IT REALLY REQUIRED THE GROSS INEQUIT IS OF IMPACT OF THE PANDEMIC AS WELL AS BROADER AWALKENNING OF THOSE THROUGH THE DEATH OF GEORGE FLOYD AND THE BLACK LIVES MATTER MOVEMENT TO MAKE JUSTICE RENEW THE PRIORITY OF JUSTICE AND THE RESEARCH ENTERPRISE. SO I'M REALLY LOOKING FORWARD TO TODAY'S DISCUSSION AND TO THE OPPORTUNITY TO LEARN FROM ALL OF YOU 1 MORE THING BEFORE WE GET STARTED, I JUST WANT TO RECOGNIZE YESTERDAY'S ANNOUNCEMENT FROM THE NATIONAL ACADEMIES WHICH ANNOUNCED THE ELECTION OF DR. WILKINs, TO THE NATIONAL ACADEMIES OF MEDICINE AND I WILL READ YOU HER BRIEF BLUSH, SHE WAS RECOGNIZED FOR RECOGNIZING THE DEVELOPMENT OF NOVEL METHODS TO ENGAGE TRADITIONALLY HARD TO REACH COMMUNITIES IN THE DESIGN AND CONDUCT OF CLINICAL RESEARCH EFFECTIVELY INTEGRATING PARTICIPANT AND COMMUNITY PERSPECTIVES HER INNOVATIONS HAVE TRANSFORMED GLOBAL SCIENCE AND INITIATIVES BY ADDRESSING DISPARITIES IN THE RESEARCH PARTICIPATION AND THAT'S VUBSLY SO RELEVANT TO TODAY'S DISCUSSION, SO I LOOK FORWARD TO THAT AND IT'S A PRIVILEGE TO BE WORKING WITH YOU. SO WITH THOSE INTRODUCTIONS OUT OF THE WAY, JERRY DO YOU WANT TO ADD ANYTHING? >> THANK YOU STEVEN, I WOULD CERTAINLY LIKE TO ECHO YOUR COMMENTS CONGRATULATING DR. WILKINS, IT WAS JUST A REFLECTION, MORE BROADLY OF SUPERB GROUP OF PEOPLE WHO WORK WITH SACHRP AND ARE ON SACHRP AND PART OF THIS IN TERMS OF THESE CHALLENGING TIMES WE LIVE IN ON OUR END, WE CONTINUE TO BE IMPRESSED BY THE DEDICATION OF EVERYBODY INCLUDING, IN PARTICULARLY THE SUBCOMMITTEE CHAIRS, THE SUBCOMMITTEE MEMBERS, THE EXPECTATIONS OFFICIOS, EVERYBODY ELSE THEY WORK WITH, WE'RE GRATEFUL TO THE MEMBERS OF THE PUBLIC SOAP AGAIN IT CONTINUES TO BE VERY, VERY IMPRESSIVE THAT ALL THESE PEOPLE IN THESE DEMANDING TIMES ARE SO WILLING TO GIVE OF THEIR TIME AND EFFORT AND AS YOU IN NOTED STEPHEN, THERE IS A GREAT DEAL OF IMPORTANCE ATTACHED TO THE TOPICS THAT SACHRP AND TAKING ON. I ALSO WANT TO SAY AT THE BEGINNING, IT'S IMPORTANT TO NOTE THAT THIS IS YOUR LAST MEETING THAT YOU WILL SERVE AS CHAIR AND WE ARE VERY, VERY GRATEFUL AND I'M SAYING THIS ON BEHALF OF OHRP BUT ALSO MYSELF PERSONALLY, IT'S SAD TO SEE YOUR TERM AT THIS CHAIR ENDING. LET ME JUST SAY A LITTLE BIT ABOUT EVERYTHING THAT'S BEEN ACCOMPLISHED IN YOUR TENURE. YOU'VE BEFORE CHAIR SINCE JULY OF 2017 AND PRIOR TO THAT YOU SERVED ON 3 YEARS AS A SACHRP MEMBER. YOU PRESIDED OVER SACHRP DURING A VERY PRODUCTIVE PERIOD AND NOT JUST A PRODUCTIVE PERIOD BUT OBVIOUSLY A PERIOD IN WHICH A LOT OF CHALLENGES HAVE BEEN TAKING PLACE, BOTH IN TERMS OF THE COMMON RULE BEING REVISED FOR THE FIRST TIME IN DECADES WHICH CREATED ITS OWN ISSUES IN THIS PANDEMIC CAME ALONG. SO IT WAS A LOT OF THINGS HAPPENING, JUST TO HIGHLIGHT SOME OF THE THINGS THWACK SACHRP HAS DEALT WITH. IT'S DEALT WITH THE COMMON RULE REVISIONS, TOPICS SUCH AS BROAD CONSENT, NEW OTHER CONSENT PROVISIONS, INTERPRETING EXPERT REVISED EDITIONS, REVIEW LIST, BROADER ETHICAL ISSUES SUCH AS CHARGING SUBJECTS FOR CLINICAL TRIAL PARTICIPATION, PAYMENT TO RESEARCH--FOR DEALING WITH A PANDEMIC INCLUDING JUSTICE AS AN ETHICAL CONCEPT. YOU'VE ALSO HAD TO DEAL WITH THE, YOU KNOW PRAGMATIC ISSUES OF GOING FROM IN-PERSON MEETING TO GOING TO ONLINE MEETINGS WHICH HAS OF COURSE CREATED OTHER CHALLENGES. AND IT'S IMPORTANT TO NOTE THROUGHOUT THIS, JUST IN TERMS OF YOUR STYLE OF WORKING AND YOUR PERSONALITY, WE LIVE IN TIMES IN WHICH EVERY DAY IN THE NEWSPAPERS AND THE MEDIA, WE HEAR ABOUT TENSIONS AND DISAGREEMENT ANDS CONFLICTS AND 1 OF YOUR INCREDIBLE STRENGTHS AND YOU HAVE MANY STRENGTHS IS YOUR WILLINGNESS TO WORK WITH OTHER PEOPLE AND BRIDGE DIVIDES AND TO COME TO A CONSENSUS AND CERTAINLY ON OUR END AND AGAIN MY VIEW POINT PERSONALLY, THAT HAS BEEN HUGELY, HUGE LOW LIMITED PARTNERFUL IN TERMS OF LEADING TO RESULTS AND ENABLING TO COMMITTEE TO ACCOMPLISH AS MUCH AS IT IS CAPABLE OF ALISHING SO AGAIN, MANY, MANY THANKS FOR EVERYTHING YOU HAVE DONE. IT'S BEEN A PLEASURE AND PRIVATE SECTOR LEMMING TO WORK WITH YOU AND EVEN THOUGH THIS IS YOUR LAST MEETING PRESIDING AS CHAIR, WE'RE THRILLED THAT YOU ARE GOING TO REMAIN CHAIR THROUGHOUT THE YEAR AND WILL BE JOINING THE SUBCOMMITTEE ON HARMONIZATION SO AGAIN, THANK YOU SO MUCH STEPHEN, BACK TO YOU. TO BE HONEST IT'S HARD TO BELIEVE THIS WILL NOT BE PARADIGM OF WHAT I DO. IT'S BEEN A JOY, I CAN'T BELIEVE IT'S BEEN 4 OR 7 YEARS IF YOU COUNT THE WHOLE TENURE. ANYWAY, THANK YOU ALL TO THE OHRP STAFF, TOO WHICH TAKE THIS RUN PARTICULARLY IN THEIR RESPONSE TO THE MANDATES TO MOVE TO THE VIRTUAL PART. ANYWAY, IT'S BEEN A JOY. WITH THAT HAVING BEEN SAID, WE WILL TURN TO THE FIRST TOPIC ON OUR AGENDA WHICH IS INTERPRETATION OF PUBLIC HEALTH SURVEILLANCE. DAVID FORSTER? , OKAY, I'M OFF MUTE. LET ME KNOW IF YOU CAN HEAR ME OKAY, CAN YOU SHARE MY SCREEN. CAN YOU SEE THE PUBLIC HEALTH SURVEILLANCE ACTIVITY DOCUMENT? GREAT. OKAY, GOOD, SO WHAT I WOULD LIKE TO DO IS JUST KIND OF BRIEFLY SPEAK ABOUT, GIVE AN OVERVIEW OF THIS PARTICULAR DOCUMENT AND BASICALLY THIS HAS BEEN TO SACHRP 1 TIME BEFORE AND IT'S BEEN RUN THROUGH WITH TD SUBCOMMITTEES, I BELIEVE IT IS READY TO PASS TODAY, HOPEFULLY NOT JINXING IT WITH SAYING THAT. KEVIN WINE HATTER FOUND A FEW TYPOS LAST NIGHT, IF YOU SEE ANYMORE, WE CAN FIX THOSE BUT I HOPE WE CAN APPROVE THIS AND GET IT OUT FOR POSTING. SO IF YOU HAVE ANY CHANGES THAT INVOLVE--SUBSTANTIAL CHANGES, PLEASE IF YOU IF YOU DO, TRY TO MAKE SURE YOU HAVE A FIX IN MIND FOR THOSE PROBLEMS. AND I WILL BRIEFLY RUP THROUGH IT. SO, AT THE BEGINNING WE JUST HAVE THE CHARGE FROM OHRP WHERE THEY ASKED US TO LOOK AT THIS ISSUE OF THE PUBLIC HEALTH AUTHORITY AND PUBLIC SURVEILLANCE ACTIVITY WHICH IS FOCUSES AT THE DEFINITIONS AT 46.102 AND K, WHICH IS PUBLIC HEALTH AUTHORITY AND SURVEILLANCE ACTIVITIES AND IT CAME TO LIT THAT THESE TERS WERE NOT WELL DEFINED WHEN WE STARTED THIS CURRENT PANDEMIC AND ISSUES CAME UP ON HOW TO INTERPRET IT. SO, AT SACHRP AS BOTH THE PARENT AND THE SUBCOMMITTEES, WE CAME UP WITH A FEW KIND OF OVERARCHING BELIEFS ABOUT THIS DOCUMENT AND THE FIRST 1 I WANT TO POINT OUT IS LINE 38-42 WE DEBATED AT GREAT GREAT DEPTH WHETHER THEE WERE THESE EXCLUSIONS INCLUDING THE APPROXIMATE UBIQUITINNATION LICK HEALTH SURVEILLANCE WERE NOT RESEARCH OR WHETHER THEY WERE RESEARCH THAT DOES NOT REQUIRE COMPLIANCE WITH THE 2018 COMMON RULE AND IN THE END WE DECIDED THAT REALLY DIDN'T MATTER, THAT--NEED TO BE RESOLVED AND THEN WE HAD STARTING ON LINE 48 SOME OPENING COMMENTS OR MAYBE SOME BROAD THOUGHTS ABOUT THIS. AND THE FIRST 1 IS THAT THE EFFECT OF AN ACTIVITY, NOT FITTING UNDER THIS PUBLIC HEALTH EXCLUSION IS THAT IRB REVIEW WILL BE REQUIRED OR YOU KNOW IT MIGHT BE 1 OF THE EXISTING EXEMPTIONS, IT MIGHT REQUIRE EXPEDITE REVIEW, MIGHT NEED FULL BOARD REVIEW, MIGHT BE CONSENT OR QUALIFIED FOR WAIVER OF CONSENT BUT THAT WAS KIND OF THE EXTENT OF THE ISSUE IF IT DOES NOT APPLY. SO IT'S NOT THAT THE RESEARCH CAN'T GO FORWARD, IT'S NOT THE END OF THE WORLD, IT'S JUST REALLY GOING THROUGH THE FORMAL REVIEW PROCESS. SECOND, WE MADE THE POINT AND WE REITERATE THAT JUST BECAUSE THE AGENCY IS A PUBLIC HEALTH AUTHORITY THAT DOES NOT MEAN THAT EVERYTHING THEY DO IS A PUBLIC HEALTH ACTIVITY OR FALLS UNDER THE PUBLIC SURVEILLANCE ACTIVITIES. THOSE NEED TO BE LOOKED AT AS ACTIVITIES BY THEMSEVES NOT JUST AS AN AGENCY FUNCTION PARTICULARLY IF THE AGENCY DOES LOTS OF THINGS THAT ARE NOT PUBLIC HEALTH. THIRD, STARTING ON LINE 59 WE RECOMMEND THIS EXCLUSION BE INTERPRETED NARROWLY AND AGAIN, WE AGREE TO THE PATH IN MANY PLACES THAT IF YOU WERE TO INTERPRET THIS BAUDLY, IT WOULD END UP ALLOWING MANY ACTIVITIES THAT WE BELIEVE OUR RESEARCH TO BE EXCLUDED FROM COVERAGE BY THE COMMON RULE. SO WE THINK THAT THE NARROW INTERPRETATION OF THE VARIOUS DEFINITIONS IS APPROPRIATE. AND THEN FINALLY AN ISSUE WE SPEND A LOT OF TIME ON, STARTING ON LINE 64 WAS THAT A GRANT OF AUTHORITY AS USE INDEED 102 K IS NOT SYNONYMOUS WITH A GRANT IN THE MEANING OF SUPPORT FROM AN AGENCY SUCH AS THE NIH GRANT, THAT THOSE ARE 2 SEPARATE TERMS, DIFFERENT MEANINGS AND SO WE SEPARATE THOSE OUT VERY CAREFULLY [INDISCERNIBLE]. SO THOSE ARE KIND OF THE OVERALL THEMES THAT GO THROUGH OUR RESPONSES TO THE VARIOUS QUESTIONS. THEN WE HAVE THE ACTUAL QUESTIONS FROM OHRP. MY THOUGHT WAS IN PRESENTING THESE THAT I WOULD JUST ASK IF ANYONE HAS ANY CONCERNS ABOUT THAT OPEN SECTION AND THEN RATHER THAN LOOK AT THE QUESTIONS IN DETAIL JUST ASK IF ANY OF MEMBERS HAVE CONCERNS ABOUT THE QUESTIONS, SO I WOULD LIKE TO START WITH ASKING IF ANYONE HAS ANY CONCERNS OR TYPOS TO CORRECT ANYTHING ELSE UP UNTIL LINE 85. >> WE HAVE AN ECHO AND A DELAY, ARE OTHER PEOPLE HEARING THAT AS WELL. >> I DID, I HEARD THAT? >> OKAY. I CAN ONLY SEE MY DOCUMENT, I CAN'T HEAR ANY PEOPLE FOR WHATEVER REASON, SO HEARING SILENCE, I WILL CONTINUE EMPLOY I DON'T KNOW WHY I CANNOT GET RID OF THE OTHER SCREEN. SO I CAN'T SEE ANY HANDS THAT ARE UP. >> NO, I THINK THERE MAY BE SOME WAY FOCUSED ON GET A PANEL OF--SO THERE A--I DON'T KNOW WHAT IT LOOKS LIKE TO THE PRESENTER. THERE'S A LITTLE THING UP BY--SO I CAN SEE YOUR SLIDES AND THEN THERE'S A STRIP ACROSS THE TOP WITH FACES. I'M NOT SURE IF YOU CAN GET TO THAT OR NOT PROBABLY NOT IF YOU'RE SHARING YOUR WHOLE SCREEN AS OPPOSED TO SHARING THE DOCUMENT. BUT THE OTHER THING IS I'M WATCHING FOR RAISED HANDS SO IF PEOPLE HAVE COMMENTS, KIBRING THOSE TO DAVID'S AWARENESS. >> OKAY, GREAT. THANK YOU. SO MOVING ON THEN WITH QUESTION 1, AGAIN I WON'T GO OVER AND READ IT AND DEFINE IT, DOES ANYBODY HAVE ANY COMMENTS OR QUESTIONS THEY WOULD LIKE TO ADDRESS. OKAY, I WILL MOVE ON TO QUESTION 2, STARTING ON LINE 176. ANY COMMENTS OR QUESTIONS ON QUESTION 2? STARTING TO SEE A FEW TYPOS, QUESTION 3, QUESTIONS OR COMMENT OKAY QUESTION 4? STARTING ON LINE 366. OKAY, QUESTION 5 STARTING ON LINE 384? QUESTION 6 STARTING ON LINE 401. HAD A FEW MORE TYPOS THAT WERE THERE THAT WERE CORRECTED. QUESTION 7 STARTING ON LINE 419? AND FINALLY QUESTION 8? OKAY. >> AFTER THAT WE MOVED ON TO JUST A BRIEF SUPPORT OF THE CURRENT SACHRP COMMENTARY ON ON THE OHRP DRAFT GUIDANCE ON THIS ISSUE. WE BASICALLY SAID THAT WE AGREED WITH EVERYTHING IN THAT DOCUMENT AND HIGHLIGHTED 2 OF THE IMPORTANT POINTS THAT WE HAD KIND OF DISCUSSED ABOVE IN OUR RESPONSES TO QUESTIONS. AND THEN FINALLY THE LAST THING AFTER THAT WAS AN ALGORITHM AND ONLY THING I DID HERE IS I FINALIZE THE NUMBERING. SO WE WILL CLEAN THAT UP FOR PUBLICATION. AND THAT POINT THERE IS REALLY NO MORE TO DISCUSS. >> SO ANY COMMENTS? CHANGES? THIS WILL BE YOUR LAST OPPORTUNITY BECAUSE IF THERE ARE NO COMMENTS WE WILL GO TO A VOTE. WHICH WILL GIVE US A LOT OF EXTRA TIME IN THE MEETING. BUT THANK YOU DAVID. I HAPPENING THIS WAS VERY IMPORTANT PIECE OF WORK AND IT DID EVOLVE FROM WHEN WE FIRST TOOK IT ON. >> YEAH, WE DID, WE ENDED UP CHANGING OUR VIEWS QUITE A BIT OVER THE PERIOD. AND I THINK TO MY READ, THE--AS YOU POINTED OUT IN THE BEGINNING, THE OVERARCHING MESSAGE IS WE WANT TO INTERPRET THIS NARROWLY. OBVIOUSLY WE HAVE TO MAKE IT GO FORWARD IN CONTEXT OF THE PUBLIC HEALTH EMERGENCIES BUT AT THE SAME TIME WE DON'T--WE HAVE TO BE CAREFUL NOT TO SET, OR PUT PRECEDENCE IN PLACE THAT MAKE IT POSSIBL TO INTERPRET IT, I THINK MORE BROADLY THAN IT WAS INTENDED AND USE IT AS A WAY AROUND ETHICAL OVERSIGHT FOR BROAD CATEGORIES OF RESEARCH. AS A MATTER OF CONVENIENCE. ALL RIGHT, ANY LAST COMMENTS. SO LET ME SEE, VOTING--VOTING IS A CHALLENGE SO DAVID CAN YOU UNSHARE YOUR SCREEN. >> YES. >> AND I JUST GO DOWN THE ROSTER, WE HAVE PLENTY OF TIME AND THAT WILL BE MUCH MORE STRAIGHT FORWARD THAN TRYING TO WATCH PEOPLE'S HANDS GO UP OR OTHER THINGS. SO, I'M GOING TO CALL ON PEOPLE AND SO FIRST WE NEED A MOTION TO APPROVE. NTHERE WAS LESLIE. >> AND A SECOND? MOVED AND SECONDED TO ARK PROVE THE GUIDANCE, THE RECOMMENDATIONS ON PUBLIC HEALTH SURVEILLANCE AND I WILL DO A ROLL CALL VOTE, MARY ELLEN? OKAY, I WILL COME BACK TO MARY ELLENOIR? >> JODI? >> THANK YOU. >> LINDA? >> APPROVE. >> DOUG. >> THANK YOU. >> JANET? >> [INDISCERNIBLE] SKIP? YOU CAN ALSO GIVE SOMETHING VISIBLE WITH AN UP OR DOWN THUMB OR SOMETHING IF THERE ARE TECHNICAL ISSUES. I SEE YOU ARE STILL MUTED. AND LESLIE? THANK YOU. AND MARY ELLENOIR, ARE YOU THERE? >> YES, I APPROVE. >> THANK YOU VERY MUCH. MOTION PASSED. THANK YOU. >> WELL THANK YOU ALL THAT WAS A DIFFICULT DOCUM AND IT TOOK US A--DOCUMENT BUT IT TOOK A WHILE AND WE CAME TO A GOOD END ON IT. THANK YOU VERY MUCH. >> THANK YOU. DAVID. OKAY SO WE'RE CONSIDERABLY AHEAD OF TIME I THINK WE DID HAVE A BREAK--A 15 MINUTE BREAK SCHEDULED AT 12:45 TO 1. WHICH WAS SUPPOSED TO BE I GUESS A QUICK LUNCH SO WE--WE WILL EXPAND THAT, MAYBE START THAT BREAK AT 12:30 BUT THAT STILL LEAVES US AN HOUR NOW. I DON'T THINK--SO AS YOU KNOW FROM THE AGENDA WE'RE HAVING A PANEL FOR THE JUSTICE DISCUSSION, SO WE REALLY CAN'T START THAT EARLY, I KNOW SOME OF THE PANEL MEMBERS ARE NOT ON THE CALL YET. >> STEPHEN, THIS IS JULIA, YOU MIGHT WANT TO CONSIDER DAVE BORASKY'S DOCUMENT GOING NOW IF HE'S PREPARED FOR THAT. >> THAT WAS WHERE I WAS HEADED. SO DAVID ARE YOU GAME? >> I DIDN'T HEAR YOU. >> SO YOU'RE NOT LISTED AS MUTED BUT YOU ARE MUTED. >> HOW ABOUT NOW? >> NOW IT WORKS. >> ALL RIGHT. >> SO WE'LL GO TO WHAT WAS SCHEDULED AT 3:15 WHICH IS RISKS TO NONSUBJECTS AND THANK YOU DAVID FOR BEING FLEXIBLE. >> YEP. NO PROBLEM. >> OKAY, I WILL SHARE MY SCREEN STEPHEN CAN YOU SEE MY SCREEN AND IS IT LARGE ENOUGH? >> YES, I THINK YOU'RE GOOD DAVE. >> ALL RIGHT, GREAT. ALL RIGHT BEFORE DIVING INTO IT DOCUMENT, IT HAS CHANGED SENSE THE LAST TIME THAT IT CAME BEFORE SACHRP AND AT THAT POINT IN TIME, WE HAD A PRETTY ROBUST DISCUSSION ABOUT THE FUTURE OF THE DOCUMENT AND DISCERNING WHAT WAS SORT OF THE RIGHT WAY TO GO WITH IT, FRANKLY WITH PEOPLE FALLING INTO A COUPLE OF CAMPS THAT WERE SIMILAR TO THE SAME SORT OF BOUNDARIES THAT WE HAD IN THE SUBCOMMITTEE WHICH IS THAT THERE WERE SUBSTANTIAL CONCERNS PARTICULARLY FROM PEOPLE ROOTED IN IRB WORK OR IRB OPERATIONS OR IRB MANAGEMENT, OR IRB SERVICE ABOUT CREATING A NEW CATEGORY OF CONSIDERATIONS THAT WERE EXTRA REGULATORY FOR IRBs TO CONSIDER THAT WERE SIGNIFICANT CONCERNS ABOUT PRACTICE RESEARCHICCABILITY OF HAVING IRBs TAKE ON THIS ROLE AND MISSION CREEK CONCERNS AS WELL AND ON THE OTHER SIDE OF IT, THERE WERE A DESCENT NUMBER OF PROBABLY THE OTHER HALF OF PEOPLE THOUGHT THAT WE SHOULD CONTINUE TO TRY TO PURSUE THIS AND SEE WHERE WE COULD TAKE IT. SINCE THAT TIME, IT'S GONE BACK TO THE SUBCOMMITTEE A FEW TIMES, WE HAVEN'T RESOLVED THE CONFLICT WITHIN THE SUBCOMMITTEE BUT THE DOCUMENT ITSELF HAS MADE PROGRESS AND I'M HAPPY TO TALK US THROUGH IT THIS MORNING AND INTO THE BEGINNING OF THE AFTERNOON. AND YOU KNOW SEE IF WE CAN TO FIND A PATH FORWARD AND WHAT ARE THE NEXT STEPS FOR THIS PIECE. FOR PEOPLE THAT MAY COMMENT AT THE LAST SACHRP MEETING HOPEFULLY A NUMBER OF ISSUES THAT WERE RAISED AT THAT TIME WERE CONSIDERATIONS THAT WERE RAISED IN THAT DISCUSSION HAVE BEEN REFLECTED IN THE DOCUMENT. WE'VE DONE OUR BEST TO INCORPORATE THOSE INTO THE SUBCOMMITTEE. THERE ARE ALSO SOME THINGS THAT WE HAVE NOT BEEN SUCCESSFUL AT WORKING INTO THE DOCUMENT AND SOME SUGGESTIONS THAT SEEM TO HIT A DEAD END SO FOR EXAMPLE, THERE WAS TALK AT THE SACHRP MEETING OF APPROXIMATER HAPPENS COMING UP WITH A CHECK LIST OR A TOOL THAT IRB--COME TO FRUITION THAT WE WOULD HAVE THAT SO WE DON'T HAVE THAT YET. AND THERE'S CONCERN THAT IT MAY NOT BE POSSIBLE TO DEVELOP 1 THAT IS SUBSTANTIVE ENOUGH TO SERVE ON AN IRB ON A REGULAR BASIS BUT SPECIFIC ENOUGH TO HELP THEM ACTUALLY WORK THROUGH ISSUES IN A MEANINGFUL WAY. THE DOCUMENTS ALSO UNDERGONE QUITE A BIT OF REORGANIZATION SINCE THE LAST TIME WITH NEW SECTIONS ADDED OR PREVIOUS SECTIONS SPLIT UP INTO OTHER COMPONENTS. HOPEFULLY PROVIDING A BIT MORE CLARITY WITH THE DOCUMENT AND WE'LL SEE WHERE WE GO TODAY. SO I THINK WHAT I'LL DO IS WALK THROUGH THE DOCUMENT, THERE ARE SOME THINGS IN THIS DOCUMENT IF YOU HAD A CHANCE TO GO THROUGH IT THAT ARE TRACKED AND THOSE ARE SOME OF THE MORE RECENT AND LARGER CHANGES TO THE DOCUMENT. THERE HAVE BEEN A NUMBER OF SMALL EDITS, SOME OF THE REORGANIZATIONS NIZZATION AND CHANGES THAT WE'VE NOT TRACKED BECAUSE FRANKLY THE TRACK VERSION OF IT WAS ALMOST UNREADABLE BECAUSE SO MANY THINGS WERE MOVED AROUND AND YOU KNOW IN THE TIME SINCE THE LAST THAT'S SHOWING YOU A TRACK VERSION OF THAT WOULD HAVE BEEN INCREDIBLY DISTRACTING AND I THINK IT MADE IT VERY DIFFICULT TO FOLLOW ALONG. SO IF THERE'S IMES AS WE GO THROUGH, WE NOW HAVE THE GIFT OF TIME, AND I WILL NOT MAKE THE BOLD PREDICTION DAVID FORSTER SAID THIS DOCUMENT WOULD GOT TO THE FINISH LINE TODAY BECAUSE IF YOU GOT TO THE END OF IT, THERE ARE SECTIONS TO BE DETERMINED THAT CANNOT BE WRITTEN I THINK UNTIL WE SORT OF KNOW THE FINAL DIRECTION OF THE DOCUMENT. SO I'LL JUST START BY GOING THROUGH SECTION BY SECTION AND INVITE COMMENTS FROM FROM THE GROUP AND I WILL TRY TO KEEP AN EYE ON--I HAD THE SAME PROBLEM AS DAVID. IT'S HARD TO TRY TO KEEP AN EYE ON WHOA HAD THEIR HANDS UP BUT LET ME SEE IF I CAN MAKE THAT PART OF MY SCREEN BIGGER SO I CAN WATCH FOR THOSE THINGS, AND I WILL TRY TO TRACK IN SOME COMMENTS AS WE GO OR AS NECESSARY. LET'S MAKE SURE THAT WORKED. OKAY, SO IN THE BEGINNING THE INTRODUCTION HAS BEEN SHORTENED A LITTLE BIT IT STILL RETAINS THE FLAVOR OF WHAT IT ORIGINALLY HAD. THERE USED TO BE CITATIONS OR CALL OUTS OF REGULATIONS IN THIS INTRODUCTORY SECTION AND THEY'VE BEEN MOVED AND CONSOLIDATED IN A SECTION DEALING WITH THE REGULATIONS. OTHERWISE, THIS IS 1 SECTION THAT'S REMAINED LARGELY UNTOUCHED SINCE THE BEGINNING, YOU WILL NOTICE THAT THERE'S A COMMENT THAT'S LINGERING IN HERE, IT'S BEEN THERE FOR A LITTLE WHILE BECAUSE WE HAVEN'T HAD A SATISFYING ANSWER BUT THERE WAS AT LEAST 1 COMMENTER WHOSE CONSISTENTLY SAID THAT YOU KNOW IF WE'RE GOING TO MAKE QUESTIONS ABOUT WHAT IRBs ARE DOING OR WHAT THEY'VE DONE WELL, THEN DO WE HAVE ANY EVIDENCE TO BACK THAT UP? AND I HAVE NOT GONE AND LOOKED THROUGH THE LITERATURE TO SUPPORT ANY OF THESE CLAIMS. WE COULD EITHER SOFTEN THE CLAIM OR SAY THERE'S NO EVIDENCE TO SHOW THAT THEYN'T ADDRESSED THEM BUT THAT COMMENT MIGHT POP UP A COUPLE TIMES WHERE IF IT'S NOT CALLED OUT AS A COMMENT, THERE ARE A FEW AREAS WHERE OUR COMMENTERS HAD A QUESTION ABOUT THAT. THAT NOT WITHSTANDING ANY QUESTIONS ABOUT THE INTRODUCTION? I DON'T SEE ANY HANDS SO I WILL KEEP ROLLING. >> SO WE HAVE A COUPLE OF HANDS DAVID. WALTER AND SKIP BOTH HAVE HANDS RAISED. >> APOLOGIES. >> YEAH, DAVID, MY HANDS ARE SMALL ON THE SCREEN. TWO-POINTS. THEY'RE REALLY EASY 1 IS LINE 22, WHERE LET'S GET RID OF THE WORD HAVE BUT MORE GENERALLY I THINK 1 OF THE KEY POINTS THAT CAME UP IN OUR LAST DISCUSSION CONCERNED NOT SO MUCH RISKS OF VACCINE AND VECTORS BUT THEY WERE PARTICULARLY AROUND CHALLENGE STUDIES WHICH HAVE RECEIVED QUITE A BIT OF ATTENTION IN THE NEWS AND WE'RE NOT SO ACCUSTOMED TO CHALLENGE STUDIES IN INFECTIOUS DISEASES AND CERTAINLY NOT IN VACCINES AND CERTAINLY NOT FOR VACCINES--FROM THIS INTRODUCTION AND IT SHOULD BE CAPTURED. >> OKAY. JUST TAKING NOTES, SKIP. >> YEAH, I AGREE WITH WALTER, I'M ALSO WONDERING IF THAT SENTENCE THAT'S HIGHLIGHTED IS REALLY EVEN NECESSARY TO THE PARAGRAPH. I MEAN YOU COULD SAY THAT YOU KNOW THAT VACCINES AND VECTORS HAVE BI STANDER RISKS, I'M NOT SURE WHY YOU HAVE TO SAY IRBs USED TO OR NOT, IT'S NOT RELEVANT TO THE DOCUMENT ITSELF, SO YOU COULD GET RID OF THE SENTENCE. >> DOUG ALSO RAISED HIS HAND. >> I AGREE WITH WHAT SKIP SAID, I DON'T THINK THAT STATEMENT IS TRUE, I DON'T THINK IT'S TRUE FOR OUR IRB AND I AGREE, I DON'T THINK IT'S NECESSARY. >> DAVE I WILL TAKE AN OPPORTUNITY TO MAKE A GENERAL COMMENT WHICH I DID AT 1 OF THE SUBCOMMITTEE CALLS AND I DON'T KNOW IF THIS BELONGS IN THE INTRODUCTION OR SOMEWHERE ELSE BUT IT DID STRIKE ME WE SPENT SO MUCH TIME TALKING ABOUT WHAT'S THE RIGHT WORD TO USE FOR PEOPLE INVOLVED IN RESEARCH, PARTICIPANTS VERSUS SUBJECTS WITH ALL THEIR CONNOTATIONS AND I THINK THIS IS 1 CIRCUMSTANCE WHERE IT'S VERY--WHERE IT'S CLEAR THERE IS A DIFFERENCE BETWEEN THE MEANING OF THOSE 2 WORDS. SO IF WE STOP SAYING HUMAN RESEARCH SUBJECTS AS A TERM OF ART AS EVERYBODY WHO GETS--SIGNS A CONSENT FORM, AND ACTUALLY TALK ABOUT THE SUBJECTS OF RESEARCH THAT'S DIFFERENT THAN THE PARTICIPANTS AND I DON'T KNOW WHETHER THIS IS WORTH SAYING OR NOT, I'M NOT SURE IT'S SUBSTANTIVE BUT IT'S JUST SORT OF A--WHAT WE'RE ADDRESSING HERE IS THE IRB IS CHARGED EXPLICITLY WITH RISKS TO THE PEOPLE WHO ARE THE SUBJECTS OF RESEARCH BUT THEY'RE NOT NECESSARILY EXCLUSIVELY CHARGED IN THE PARTICIPATED IN THE RESEARCH BUT NOT NOSES'RE IN SAYSLY RESEARCH SUBJECTS SO THIS IS AN INSTANCE WHERE THOSE 2 TERMS DON'T DIRECTLY OVERLAP AND YOU TALK ABOUT THAT, YOU TALK ABOUT PEOPLE WHO ARE NONSUBJECTS AND PARTICIPANTS, I WONDER GIVEN THE ONGOING ISSUE ABOUT USE OF THOSE TERMS WHETHER YOU SHOULD MAKE IT EXPLICIT. JUST A THOUGHT. >> YEAH, YOU DID RAISE THAT BEFORE, I MEAN, I THINK YOU KNOW THE CHALLENGE--THE CHALLENGE I HAD IN TRYING TO TAKE THAT SOMEWHERE, 1, YOU KNOW I FEARED IT COULD BECOME A DISTRACTION AND MAYBE ALTHOUGH, MAYBE IT COULD BE WOVEN IN WHEN WE TALK ABOUT SORT OF THE NON--THE BI STANDERS, THE NONSUBJECTS WHO ARE EXPOSED TO RISK. I DON'T KNOW IF THERE--I DON'T KNOW THAT ALL OF THOSE COUNT AS PEOPLE WHO PARTICIPATE IN RESEARCH. I MEAN, YOU KNOW A CAREGIVER OF SOMEBODY CLEARLY HAS A ROLE IN HELPING THE SUN SUBJECT PARTICIPATE IN RESEARCH BUT THERE ARE OTHER KINDS OF BI STANDERS AS WELL THAT I THINK WE DON'T INTEND TO PULL IN. I DON'T KNOW. IT BECAME DIFFICULT TO DISCREETLY SORT OF CARVE OUT AND MAKE--YEAH. >> NO, I CAN SEE THAT,. >> YEAH. >> SO IT MAY BE FOR A DISCUSSION FOR A DIFFERENT PLACE. >> AND I PERSONALLY WOULD FEAR--I MEAN THERE'S--YOU KNOW THE WHOLE ISSUE OF THE LANGUAGE OF SUBJEKS VERSUS PARTICIPANTS AND YOU SACHRP CONTEXT WE'VE BEEN ENCOURAGED TO STICK TO SUBJECTS THAT RAISES OTHER ISSUES WITH PEOPLE THAT OTHERS HAVE WITH THE ISSUE AND I DON'T KNOW THAT THIS IS THE DOCUMENT TO TRY TO WADE INTO THOSE WATERS OR CREATE THAT KIND OF CONFUSION. >> OKAY. >> I THOUGHT I WOULD BRING IT UP. TO ME IT'S A HELPFUL WAY FOR ME TO THINK ABOUT IT BUT, YEAH. >> DAVID, I HAD MY HAND UP AND SINCE IT'S RELATED, I THOUGHT I WOULD INTERRUPT. SORRY ABOUT THAT. >> PLEASE, GO AHEAD. >> I DO AGREE AND I FEEL PERHAPS MORE PASSIONATELY THAN SOME THAT WE SHOULD BE PUSHING FOR GREATER DISTINCTION BETWEEN PARTICIPANT AND SUBJECT AND KEEPING REALLY SUBJECT TO THOSE PEOPLE--I THINK IF WE'RE WORRIED ABOUT CONFUSING PEOPLE, IT'S ALREADY CONFUSING, SO, TO THE DEGREE THAT WE CAN ACTUALLY ADD SOME CLARITY OR MAKE CLEAR HOW WE'RE DEFINING THESE, AT LEAST IN THE CONTEXT OF THIS DOCUMENT, THAT WOULD BE HELPFUL AND THAT MIGHT NOT MEAN WE'RE SPECIFICALLY TALKING ABOUT PARTICIPANT VERSUS NON, BUT, I DO THINK THAT IF IT'S NOT CLEAR WE SHOULD PERHAPS THINK MORE ABOUT HOW TO--HOW TO MAKE IT CLEAR, NONSUBJECTS. I ALWAYS FIND PUTTING NONIN FRONT OF A TERM DOESN'T NECESSARILY MAKE US UNDERSTAND WHAT IT MEANS. >> SO CONSWALE O, AM NOT SURE IF YOU AND I AGREE OF WHAT SUBJECT MEANS, I THINK OF SUBJECT THERE AS THE SUBJECT OF RESEARCH STUDY AND YOU'RE TALKING ABOUT MORE OF SUBJECT AS A MEASURE OF VOLUNTARINESS,. >> YES. >> BUT IT DOES HIGHLIGHT THERE ARE LOTS OF DIFFERENT WAYS TO USE THESE TERMS. I THINK WE'VE USED THEM--I THINK SACHRP HAS USED THEM THIS WAY BECAUSE THAT'S THE WAY THE REGULATIONS USE THEM, SO THAT'S--WE BASICALLY MIMIC THAT BUT IF THERE'S REALLY LIKELY TO BE--SO I SAW THIS AS SORT OF AN OPPORTUNITY TO CLARIFY THINGS BUT I WASN'T--I ALSO WASN'T READING IT, I KNEW WHAT WE WERE TALKING ABOUT, IF THERE'S A POSSIBILITY THAT THIS WILL BE, THAT OTHERS WON'T FULLY GET THIS, WE HAVE TO FIGURE OUT A WAY TO RELAY. >> YOUR HAND UP FROM BEFORE OR NEW? >> I'M SORRY ARE WERE YOU REFERRING TO OR TALKING TO ME. >> NO, I WASN'T, I SAW SKIP'S HAND IS STILL UP BUT IT MAY BE UP FROM BEFORE AND THEN I CALLED ON YOU SO NOW LINDA GO AHEAD,--OR, SKIP. >> I WAS GOING TO POINT OUT NOT WITHSTANDING SOME OF THE CONCEPTUAL ISSUES WE RAISED WHICH I AGREE COULD POTENTIALLY BE WORTH CLARIFYING ALTHOUGH MAYBE NOT IN THIS DOCUMENT THAT THE WORD PARTICIPANT HAS BEEN USED AND IS PRETTY MUCH RECOMMENDED AT LEAST WITHIN CERTAIN STAKEHOLDER DPROWPS SUCH AS AT LEAST INDUSTRY, I MEAN, WE'RE USING PARTICIPANT AND SUBJECT TO MEAN THE SAME THING, SO IF WE START USING PARTICIPANT DIFFERENTLY, THAT'S GOING TO CREATE A PROBLEM. >> YEAH SO MAYBE WE NEED ANOTHER SACHRP TOPIC TO TALK ABOUT THIS BECAUSE IT SOUNDS LOAMACYIC IT HAS MULTIPLE RAMIFICATIONS. BUT I THINK THIS DOCUMENT, WE MADE EVERYTHING SUBJECT IN THIS DOCUMENT EXCEPT WHEN WE REFER TO HOW OTHER PEOPLE TALK ABOUT THEM. I THINK THAT'S RIGHT, DAVE, ISN'T IT? >> IT SHOULD BE, THAT WAS 1 OF THE TASKS I HAD COMING OUT OF A RECENT SUBCOMMITTEE MEETING AND AS YOU SAID, I MEAN, SETTING ASIDE THE ISSUES AROUND THE TERMINOLOGY, WE'VE CONSISTENTLY AT SACHRP BEEN ENCOURAGED TO STICK WITH THE REGULATORY LANGUAGE. >> YEAH, SO LET'S JUST FILE THAT 1 AWAY BECAUSE I THINK THE DOCUMENT IS INTERNALLY CONSISTENT. I THINK-- >> CONSWALE O'S POINT ABOUT NOT PUTTING NONSUBJECTS, MAYBE WE CAN LOOK AT THAT LANGUAGE BUT I THINK PERHAPS NOT THE TIME TO RAISE THE PARTICIPANT VERSUS SUBJECT ISSUE. LINDA? >> I'M SORRY, I APOLOGIZE, I WAS GOING TO MAKERS AND A GBL COMMENT, I'M NOT SURE HOW PEOPLE FEEL ABOUT THIS IN TERMS WAS INTRODUCTION, I KNOW THAT THE REASON WHY WE--THIS IS SOMETHING THAT IS BEING CONSIDERED IS BECAUSE OF THE COVID-19 PANDEMIC AND THAT'S WHAT SPARKED IN KOEVERGZ BUT I WONDERING WHETHER IT WOULD BE POSSIBLE NOT TO ADD LAY LOT OF SPECIFIC EXAMPLES IN THE INTRODUCTION TO KEEP IT MORE GENERAL AND THEN MOVE SOME OF THE SPECIFIC EXAMPLES OF HOW THIS MIGHT APPLY LATER ON IN THE DOCUMENT? I'M JUST LOOKING AT IT AGAIN WITH FRESH EYES AND I WAS WONDERING HOW PEOPLE FELT ABOUT THAT? NYEAH I'M CURIOUS TO HEAR OTHERS THOUGHTS ABOUT THAT AS WELL. I'M JUST TAKING NOTES ABOUT IT, IT WOULD BE POSSIBLE TO DO THAT, YOU KNOW TO MAKE THE INTRODUCTION A BIT MORE I GUESS GENERIC AND THEN IF I TAKE WHAT YOU JUST SAID LINDA AND KIND OF--OF RISKS TO OTHERS? >> SO DOUG AND WALTER BOTH HAVE THEIR HANDS UP. >> I WOULD JUST AGREE WITH LINDA. IT READS A BIT LAKE A COVID-19 DOCUMENT WITH THAT BEING SO PROMINENT IN THE INTRODUCTION AND SO I THINK IT DOES MAKE SENSE TO MAKE IT MORE GENERIC AT THE BEGINNING AND THEN PROVIDE EXAMPLES LATER ON. >> MY RECOLLECTION OF TRAUMA ARE DISCUSSION THIS SUMMER WAS THAT THERE WERE QUESTIONS ABOUT WHETHER THE RISKS POSED TO BY STANDERS TO RESEARCH WERE REASONABLY WELL ARTICULATED AND EXISTING REGULATIONS AND THAT THERE WERE SOME ISSUES THAT WERE--THAT COVID-19 POSED THAT RAISED THIS AS BEING A TIMELY TOPIC. SO I--I UNDERSTAND THE GENERAL OBSERVATION THAT THIS, WE DON'T WANT THIS TO BE POSITIONED AS A COVID-19 TOPIC BUT I DO THINK IT'S IMPORTANT TO PERHAPS IN THE INTRODUCTION TO INDICATE THAT IT'S KIND OF COVID-19 ISSUES THAT HAVE CATALYZED THE REEXAM NATION OF THIS BROADER TOPIC. >> LINDA DID YOU HAVE YOUR HAND UP AGAIN? >> I ACTUALLY WAS JUST GOING TO MAKE A COMMENT AND I THINK THAT IN TERMS OF WHAT YOU JUST SAID, I THINK THAT KIND OF MAKES SENSE THAT WHAT PROMPTED IT IS THIS PARTICULAR ISSUE BUT THEN IF WE REMOVE THE EXAMPLES LATER ON, WE IT MIGHT MAKE IT FLOW BETTER AND I CAN THINK OF ARK DITIONAL SAMPLES THAT WE CAN SEE THAT ARE A BIT MORE GENERAL IN NATURE WHERE OUR IRBs HAVE, YOU KNOW LOOKEDDA THE THIS PARTICULAR ISSUE AND MAYBE KIND OF TOUCH UPON IT LATE OR SO I THINK THAT DOES MAKE SENSE WHAT YOU JUST SAID. >> ALL RIGHT, THAT'S HELPFUL AND I AM NOT PUTTING IT IN THE DOCUMENT, BUT I AM MAKING NOTES SO THAT I CAN PUT THIS IN THERE LATER BAH IT WILL TAKE A BIT OF WORK TO DO THAT BUT I THINK IT MAKES SENSE WITH MAKING THE INTRO MORE GENERIC AND THERE'S NO HARM IN INDICATING THAT THE COVID-19 RELATED ISSUES THAT HAVE,A RISEN HAVE SORT OF-SHOULD HAVE WHAT BROUGHT THIS TO THE ATTENTION OF SACHRP IN THE CURRENT MOMENT. SO I CAN DEFINITELY WORK ON THAT. OKAY, ALL RIGHT. SORRY, WHEN HANDS ARE UP, THEY'RE AWFULLY SMALL. MOVING ON THEN THIS THE NEXT SECTION WAS YOU KNOW TRYING TO DRIEB WHAT WE MEAN WITH HOW WE'RE DEFINING SOME OF THE TERMS. AND SO YOU KNOW WE START OFF--THERE'S BEEN COMPETING QUESTIONS ABOUT WHEN WE FIRST SAY WHO'S INCLUDED AND EXCLUDED IN THE SCOPE OF THIS DOCUMENT AND SAYING WHAT WE MEAN BY BYSTANDERS AND THE 4 PARAGRAPHS BETWEEN LINES 30 AND 50 DO THAT AND EVEN THOUGH I THINK THE TITLE OF THE DOCUMENT MAY STILL SAY NONSUBJECTS, I BELIEVE AT LEAST THE SUBCOMMITTEE LEVEL WE SETTLED THEM BY STANDARDS, IT SEEMS TO BE THE TERM USED MOST CONSISTENTLY IN THE LITERATURE AND THAT'S WHY IT'S REFLECTED IN THE DOCUMENT EVEN THOUGH THE TITLE SAYS DIFFERENTLY. ANYHOW, OPEN FOR COMMENTS OR QUESTIONS ON THIS SECTION. >> LESLIE? >> TAKING MY HAND DOWN AND UNMUTING. I HAD A MINOR QUESTION, IT TOARDS THE END FROM 45-49 WHERE YOU'RE DISTINGUISHING BETWEEN THOSE BYSTANDERS WHO MAY BE AWARE AND THOSE WHO MAY NOT BE. AND SOME OF IT GOES TO SCOPE, SO 1 I WOULD BE EXPLICIT OR I INTERPRETED THE FIRST OR HOWEVER ARE MUCH MORE INVOLVED AND AWARE AND I MIGHT JUST BE EXPLICIT ABOUT WHO ACCOMPANIED THE RESEARCH PARTICIPANT TO STUDY VISITS TO SORT OF HAMMER THAT HOME. IF I'M CORRECT IN THAT. AND THE SECOND QUESTION WAS FOR THE OTHERS FOR THOSE WHO ARE NOT AWARE, WONDERING HOW FAR WE INTEND TO TAKE IT, RIGHT? BECAUSE THE EXAMPLE IS QUITE INTIMATE AND WHERE, YOU KNOW--AND COULD IT BE, IN THINKING ABOUT A CHALLENGE, TODAY OR SOMETHING, SOMEBODY WHO DOES NOT HAVE THAT CLOSE RELATIONSHIP WITH THE INDIVIDUAL BUT MAY BE EXPOSED AND YOU KNOW IT REALLY IS A LARGER QUESTION AND I DON'T NECESSARILY HAVE TO HAVE THE ANSWER NOW, BUT OUR EXAMPLE YOU KNOW I WAS THINKING ABOUT SOMETHING WHO HAD SOMETHING RADIO LOGIC INJEBTED OR SOMETHING, THERE COULD BE SOMEBODY IN THEIR OFFICE, SOMEBODY IN DIFFERENT PLACES. >> YEAH. FROM--I HAD ACTUALLY WRITTEN DOWN A COWORKER EXAMPLE AS YOU WERE TALKING. SO THAT DOES MAKE SENSE AND I THINK WOULD HELP EXPAND THAT, THE UNDERSTANDING OR WHAT IS MEANT BY THAT PART OF IT. >> DOUG? JUST BUILDING ON THAT POINT. I HAVE TO ADMIT WHEN I FIRST PICKED UP THIS DOCUMENT, THE FIRST EXAMPLE THAT CAME TO MIND WAS ACTUALLY THE ARIZONA STATE STUDIES INVOLVING THE HAVI SUPI PEOPLE, AND THOSE RISKS WERE REALLY NOTHING LIKE BEING POTENTIALLY EXPOSED TO RADIATION OR INFECTIOUS VECTOR, THEY WERE MORE RELATED TO THE STIGMA OF AN ENTIRE POPULATION AND PSYCHOLOGICAL RISKS AND HARMS AND THOSE SORTS OF THINGS. >> JANET? >> I WAS JUST READING AN ARTICLE ABOUT STIGMA ASSOCIATE WIDE COVID-19. IN THE ASIAN COMMUNITY IN SAN FRANCISCO AND WHAT THEY WERE HIGHLIGHTING WAS 1 PARTICULAR CASE OF FAMILY THAT LIVES SELF-PEOPLE IN A VERY SMALL AREA BECAUSE THEY CAN'T AFFORD THE RENT IN A COMMUNAL AREA AND IMHIEWNICAL KITCHEN SO EVERYONE IN THE BUILDING COULD BE AFFECTED IF SOMEBODY HAD A PARTICULAR DISEASE AND YET FOR THAT SAME REASON, THERE'S A LOT OF STIGMA ASSOCIATE WIDE TELLING THE PEOPLE YOU'VE BEEN EXPOSED TO PARTICULAR THINGS. AND THAT IN SOME WAYS BROADENS THE INFLUENCE OF PEOPLE TO MIGHT NEED TO KNOW AND YET IT MAKE ITS DIFFICULT TO KNOW WHETHER TD IRB SHOULD BE [INDISCERNIBLE] ANYBODY. >> SO LESLIE HAS HER HAND UP TOO BUT LET ME ASKING SOMETHING, THOUGH. I THINK IN THE ORIGINAL CHARGE FOR THIS DOCUMENT, WE WERE FAIRLY--WELL IT WAS--I THINK THE ISSUE WAS PHYSICAL--RISK OF PHYSICAL HARMS TO INDIVIDUALS. THAT'S NOT IN ANY WAY TO MINIMIZE THE COMMUNITY IMPACT AND STIGMA IMPACT. I AM CONCERNED THAT WE WILL GET THIS--THIS WILL BECOME OVERLY BROAD. THAT'S JUST--THE ISSUES OF IMPACT AND RESEARCH ON COMMUNITY SYSTEM SUCH A HUGE ISSUE AND I AM CONCERNED THAT IT WILL GET--THAT IF WE TAKE THAT ON IN THIS DOCUM, WE WILL LOSE THE OTHER PIECE WHICH IS THE PIECE THAT CAME UP SORT OF MORE CONCRETELY IN THE COVID STUDIES OR CONIS VERSELY, WE COULD PUT THAT RISK MINE MYSELFING EITHER SIDE OF THOSE. SO I DON'T KNOW BUT I ALSO--I THINK IF WE DECIDE NOT TO DRAW A LINE, WE DECIDE TO DRAW A LINE, WE SHOULD BE VERY EXPLICIT ABOUT IT SO THAT WHEN WE DISCUSS BYSTANDER RISKS AND DON'T GO INTO SAY COMMUNITY STIGMA RISKS OR RISKS THAT ACCRUED TO LARGE GROUPS LIKE THAT AS A RESULT OF THE RESEARCH CONDUCT AND RESULTS ARE NOT TAKING IT ON IS NOT SEEN AS NOT SORT OF TAKING IT SERIOUSLY. SO I THINK AT A MINIMUM WE NEED TO ACKNOWLEDGE THAT SCOPE. I ALSO WONDER WHETHER, YOU KNOW FOR THOSE WHO HAVE BEEN ON THE COMMITTEE ANY LENGTH OF TIME, YOU KNOW I LOVE GRAPHICS. THEY USUALLY DON'T MAKE IT INTO THE FINAL TECHNOLOGY TRANSFER BUT THIS IS ANOTHER 1 WHERE IT SEEMS TO LAY OUT THE SPECTRUM OF BYSTANDERS. >> I PUT MY HAND UP WHEN DOUG SPOKE AND STEPHEN YOU JUST REACTED IN A SIMILAR WAY, WHICH IS I HAD NOT AND THE REGULATIONS DO NOT ADDRESS GROUP HARM BUT I UNDERSTOOD THIS TO BE ABOUT PHYSICAL HARM AND IF THAT IS WHERE WE'RE GOING TO RESTRICT IT I THINK WE SHOULD BE EXPLICIT ABOUT THAT AND EXPOLICE THE ABOUT THE REASON AND TO ACKNOWLEDGE THE OTHER TYPES--AND IF WE'RE CONCERNED ABOUT COMMISSION CREEP WITH THIS PARTICULAR ISSUE, I THINK THE LARGER ISSUE ABOUT GROUP HARM WHICH HASN'T BEEN CONFRONT WIDE REALLY WITHIN THE REGULATIONS WOULD BE MUCH MORE OF A CHALLENGE. >> THANK YOU JODI. >> I WAS GOING TO SAY, LESLIE, SUMMED IT UP RIGHT, I WAS THINKING OF SAME THING WHEN I WAS THINKING ABOUT EXAMPLES IT WAS MORE ABOUT THE VARIABLES AND REMOTE SENSING TECHNOLOGY THAT WE NOW USE AND WHICH MIGHT COLLECT BEHAVIORS AND OTHER INFORMATION FROM NONSUBJECTS SO THAT REALLY IS A MORE CIRCUMSCRIBED SCOPE AND THE IRBs WILL BENEFIT FROM SOMETHING LIKE THAT. >> SO I HAVE A NUMBER OF PEOPLE THAT HAVE THEIR HAFNEDS UP AND I WILL DO THE BEST TO GO IN THE ORDER AS I SAW THEM AND I APOLOGIZE IF I GET IT WRONG. >> AND STEPHEN, I APPRECIATE THAT BECAUSE I DON'T SEE THE HANDS. >> YOU HAVE TO BE A CO- PRESENTER TO SEE THE HANDS. >> SO I DON'T DISAGREE WITH HA WITH WHAT OTHERS HAVE SAID BUT I'M STRUGGLING WITH WHETHER IT'S REALLY A DEFENSIBLE DISTINCTION. IT'S NOT SO MUCH TO ME BETWEEN GROUP HARMS AND INDIVIDUAL HARMS BECAUSE QUITE FRANK LYE TBROWP ARMS ARE FELT BY INDIVIDUALS. I MEAN STIGMA IS NOT FELT BY GROUPS, IT'S FELT BY THE INDIVIDUALS WITHIN THOSE GROUPS AND PSYCHOLOGICAL HARMS. I DON'T KNOW IF THE DISTINCTION BETWEEN THE PSYCHOLOGICAL HARM OR THE PRIVACY VIOLATION, AND SAY A PHYSICAL HARM IS REALLY DEFENSIBLE, SO I STRUGGLE WITH THAT A LITTLE BIT, AND JUST WANT TO RAISE THAT. >> I APPRECIATE YOU RAISING THAT. IT'S AN UNDERCURRENT OF SO MUCH HOW THE REGULATIONS WERE WRITTEN AND INTERPRETED FOR SO LONG. IT'S A HUGE ISSUE AND MAYBE IF WE DO DECIDE NOT TO TAKE THE GROUP HARM ISSUE ON, WE CAN MAKE THAT EXPLICIT. IT WILL AT LEAST SERVE AS A PLACE HOLDER FOR FUTURE CONSIDERATION. IF, YEAH. >> CONSWALE O, I THINK YOU WERE NEXT. >> YEAH, WANT TO PUT A PLUG IN FOR TRYING TO ADDRESS GROUP AND COMMUNITY HARM, NOT NECESSARILY IN THIS DOCUMENT BUT IN THE FUTURE. IT'S A RECURRING ISSUE, IT'S A RECURRENT ISSUE, IT WILL COME UP IN OUR SESSION ABOUT JUSTICE, UNLESS WE REALLY ACKNOWLEDGE AND CONFRONT THE GROUP LEVEL HARMS DONE BY RESEARCH, WE WILL CONTINUE TO BE IN THESE QUANDARYS ABOUT OTHER ISSUES RELATED TO RECRUITMENT AND RELEVANCE OF THE WORK, ET CETERA. >> SO WHAT I'M HEARING IS THAT THIS IS A HUGE ISSUE THAT'S OF CONCERN TO MANY MEMBERS OF THE COMMITTEE I HAVEN'T HEARD--I HAVEN'T HEARD COMPELLING REASONS, I'M STILL CONCERNED ABOUT ADDRESSING IT IN THIS DOCUMENT BECAUSE I THINK WE WILL--AS WE WILL SEE IN THE JUSTICE DOCUMENT, CONSWALE O ABSOLUTE LE THAT'S AN ISSUE IN THE JUSTICE DOCUMENT AND I THINK IT'S GOING TO TAKE A LOT OF WORK TO FIGURE OUT WHAT WE WANT TO SAY AND WHAT THE RIGHT APPROACH IS AND I DON'T WANT TO--I THINK THIS DOCUMENT HAS OTHER WORK TO DO THAT SHOULD GET DONE BUT DAVE, I THINK WE HAVE TO BE EXFLISIT ABOUT IT AND THE SCOPE WHEN WE TALK ABOUT THAT. IF ANYONE DISAGREES WITH THAT? WE HAVE TO PROVIDE GUIDANCE TO THE IRB NOW ON THAT ISSUE EMPLOY. >> YEAH, I MEAN THE--THE 2 BRANCHES ARE 1 TO CALL IT OUT AS A KNOWN ISSUE AND EMBED A SACHRP RECOMMENDATION THAT THAT BE SEPARATELY PURSUED BUT FOR THAT DOCUMENT IT'S OUT OF SCOPE OR WE--WE TRY TO WORK IN SOMETHING ABOUT IT. IT WILL CHANGE THE DOCUMENT, BUT THAT'S THE DIRECTION IT'S GOING. >> THERE ARE A NUMBER OF PEOPLE THAT HAVE THEIR HANDS UP, BUT WE WILL GO THROUGH IT. >> I THINK IT WAS KEVIN AND WALTER AND JODI AND CONSWALE O AGAIN. >> HI, THANKS STEPHEN. SO I AGREE IT SEEMS LIKE THE DOCUMENT NEEDS TO AT LEAST SKETCH OUT THE BROADER CONTEXT OF THIS AND AND BE CLEAR ABOUT WHAT IT IS ADDRESSING AND IT ALSO STRUCK ME IT WOULD BE AN INTERESTING EXERCISE, YOU KNOW IF THE SCOPE WERE RESTRICTED IN THE WAY THAT THE FOLKS HAVE BEEN DISCUSSING TO SEE AT THE END OF IT WHAT RECOMMENDATIONS AND GUIDANCE ARE COMING OUT, THEN TO SEE TO WHAT EXTENT THOSE RECOMMENDATIONS AND GUIDANCE WOULD APPLY TO SOME OF THESE OTHER TYPES OF HARMS. THAT MIGHT HELP INFORM THE DIRECTION FOR FUTURE WORK THAT NEEDS TO BE DONE AND THEN THE OTHER--KIND OF A TRIVIAL REMARK ABOUT THE ORGANIZATION OF THE DOCUM AT THIS POINT. IT SEEMED LIKE THIS SECTION STARTS OUT, THE FIRST 2 PARAGRAPHS DISCUSSING BYSTABBEDDERS WITH THE EXPOTIONURE RISKS THE NEXT SECTION GOES TO ANOTHER GROUP OF PEOPLE AND THOSE PARAGRAPHS FROM 41-49 SEEM TO BE SKETCHING OUT CONSIDERATIONS THAT WOULD HELP INFORM HOW THESE THINGS COULD BE CONSIDERED BY AN IRB AND I JUST WONDER WHETHER THOSE WOULD FIT BETTER LATER WHEN THERE ARE MORE STUB STANTIVE RECOMMENDATIONS MORE THOSE SITUATIONS. THAT WAS ALL. >> RIGHT. I THINK THESE ISSUES ARE IMPORTANT TO CAPTURE, BUT I ALSO THINK THEY'RE DIFFICULT--SOME OF THESE ISSUES ARE DIFFICULT TO CAPTURE. IT'S NOT A GREAT ANALOGY BUT ROUGHLY, I THINK ABOUT THE WAY THAT COSTS ARE CAPTURED AND HEALTH ECONOMICS AND WHAT ARE REFERRED TO AS DIRECT MEDICAL COSTS WHICH ARE THE COSTS OF CARE AND INDIRECT COSTS WHICH ARE COSTS ASSOCIATED WITH LOSS OF WORK AND INTANGIBLE COSTS WHICH ARE THINGS LIKE EMOTIONAL BURDEN AND IT MAY BE USEFUL IN THE DOCUMENT TO THINK ABOUT--I THINK THE DRIVER FOR THIS ORIGE NAWILLLY WAS AROUND THE DIRECT--THE DIRECT CONSEQUENCES THAT QUANT FIELD FUNCTIONSABLE CONS--POTENTIAL CONSEQUENCES TO BYSTANDERS BUT THEN TO ACKNOWLEDGE AS WELL THAT THERE ARE REALLY IMPORTANT INDIRECT, YOU KNOW CONSEQUENCES AS WELL THAT ARE AND IT MAY BE A FALSE THAT I'M BEING ABOUT BUT THERE ARE THOSE PHYSICAL CONSEQUENCES AND THOSE CONSEQUENCES THAT ARE--THAT ARE ASSOCIATE WIDE STIGMA AND PSYCHOSOCIAL BURDEN. >> I THINK YOU ARE MUTED. >> SORRY, THANK YOU. SKIP? SKIP'S ALSO MUTED. >> SORRY, I FORGOT TO UNMUTE AWZ I'M ARE TALKING OF TALKING. I WOULD SUPPORT THE VIEW OF THE BURDEN OF THIS DOCUMENT WITH THE IMPORTANT ISSUE OF GROUP AND COMMUNITY HARM. I THINK WE CAN FRAME IT AS NOT COVERING IT IN THIS DOCUMENT BUT I THINK IF WE--I MEAN ISSUE IS GOING TO TAKE, I THINK A VERY CAREFUL DELIBERATION, PARSING OF LANGUAGE, ET CETERA AND IT WOULDN'T--YOU CANT DO THAT IN A FEW PARAGRAPHS. >> SO I STILL HAVE HANDS UP FROM KEVIN AND WALTER, I DON'T KNOW IF THOSE ARE NEW OR OLD. >> OLD, SORRY. >> SO, DAVE, A LOT TO THINK ABOUT NYEAH,. >> IT HELPFUL AND I CAN STRIE STOCK EXCHANGE START. I MEAN IT--SO MY PERSONAL BIAS IS I AGREE WITH, I THINK SKIP SUMMARIZED THESE CONCERNS NICELY, THIS IS EASY ENOUGH TO TRY TO WORK IN THIS THE CONTEXT OF SCOPE THAT YOU KNOW THESE THINGS ARE OUT OF SCOPE AND EVEN THE SACHRP A SEPARATE DISCUSSION OR CONSIDERATION THAT WE MADE INTO IT INTO THOSE SORTS OF GROUP AND COMMUNITY HARM ISSUES OR RISK ISSUES, BE SEPARATELY CONSIDERED BY SACHRP THAT'S A PRETTY--IT WOULD ALLOW US TO ACKNOWLEDGE THEM IN THIS DOCUMENT, CALL THEM OUT OF SCOPE AND RECOMMEND FUTURE WORK IN THAT AREA. AS I LISTEN TO KEVIN'S COMMENTS ABOUT THE STRUCTURE OF THIS SECTION AND IT ACTUALLY--IT DOES MAKE SOME SENSE, SO OF THOSE--THE LATTER 2 PARAGRAPHS OF BEING MORE TOWARDS ACTIONS OR CONSIDERATIONS BY THE IRB TO TAKE VERSUS DEFINING WHAT WE NEED BY BYSTANDERS WITH EXPOSURE TO RISK OTHERWISE THIS IS A USEFUL DISCUSSION. YOU KNOW I THINK ON OUR LAST SACHRP MEETING BACK IN THE SUMMER, THE ISSUE OF AT LEAST COMMUNITY LEVEL ISSUES WAS RAISED BUT WITHOUT SORT OF WITHOUT CONCRETE MARCHING ORDERS WHAT TO DO WITH IT AND THE SUBCOMMITTEES ACKNOWLEDGE THAT COMMENT BUT WERE NOT QUITE SURE WHERE TO TAKE IT BUT WE DIDN'T HAVE A CONVERSATION LIKE THIS SO THAT IS CERTAINLY HELPFUL. >> SO I WOULD HAVE 1 MODEL CITIZENNER CAUTION ABOUT THAT WHOLE ISSUE AND IT REFLECTS WHAT DOUG SAID EARLIER. I THINK WE'VE BEEN HAUNT FEDERAL ARE DECADES ABOUT THIS AND IT GETS TO WALTER'S CLASSIFICATION ISSUE, AND WE'VE BEEN HAUNTED BY PRETENDING THERE'S ALSO A CLENNING SEPARATION BETWEEN PSYCHOLOGICAL STIGMA, PHYSICAL HARMS THAT ALL OF THIS IS SOMETHING THAT EVERYBODY CLEARLY GETS AND AGREES WITH AND THAT THEY FORM 2 DIFFERENT HIERARCHYS OF FOR THE PURPOSE, I DON'T WANT TO DISCUSS THAT OR ARGUE IT TODAY BUT I THINK WE SHOULD JUST BE SENSITIVE TO THAT, THAT THAT MAY NOT BE AS ACCEPTED AS WE'VE SORT OF ASSUMED THROUGH THE YEARS SO THIS HAS BEEN A VERY INTERESTING CONVERSATION. YEAH. >> OKAY, I WILL CONTINUE TO MOVE ON AND WITH YOUR HELP WE WILL WATCH FOR HANDS POPPING UP. SO IN THE NEXT 2 PHOTOGRAPHS THIS WAS AN ATTEMPT TO CALL OUT A COUPLE OF CATEGORIES OF NONSUBJECTS WHO MAY HAVE EXPOSURE TO RISK BUT THAT WE WANTED TO KEEP OUT OF SCOPE FOR THIS DOCUMENT AND THE EARLIER ARGUMENTS IN THE BYSTANDER SO IN THE FIRST PARAGRAPH IT'S--THIS GETS BACK TO THE OLD ISSUE OF SECONDARY SUBJECTS THAT HAUNTED IRBs BACK IN THE EARLY 2000S, LATE 90S AND WE--WE WANT A DATE TO KEEP THAT TYPE OF INDIVIDUAL OR GROUP OF INDIVIDUALS OUT OF SCOPE AND THE LAST PHOTOGRAPH THERE, THE SECOND PARAGRAPH AT LINE 59 MEMBERS OF THE RESEARCH TEAM, NOBODY DISAGREES THAT THERE MAY BE EXPOSURE TO RISK ON SOME OF THEIR PART AND I THINK A FEW PEOPLE MAY BE TOOK ISSUE WITH THE IDEA THAT--WITH THE PRESUMPTION THESE PEOPLE IN THESE POSITIONS CHOOSE TO WORK IN THESE SITUATIONS WITH AN UNDERSTANDING OF THE RISKS BUT AGAIN, IF WE TRIED TO PULL THEM IN SCOPE, IT BECOMES AWFULLY--IT BECOMES COMPLICATED AND DISSTRACTS FROM WHAT OUR INITIAL INTENT WAS WITH THE DOCUMENT. IN THE EARLIER CONVERSATION, I CONSIDERED WHETHER OR NOT, I STARTED THINKING ABOUT WHETHER THIS WAS WHERE WE TALK ABOUT GROUP AND COMMUNITY LEVEL HARMS, BUT THAT MAY--THAT MAY REQUIRE IT'S OWN SECTION JUST TO KEEP IT APPROPRIATELY SEPARATED AND HIGHLIGHTED. >> SO 1 QUESTION, THAT FIRST PARAGRAPH FROM 51 TO 58, I JUST WOULD LIKE-- >> YES,. >> AND WHAT DO YOU THINK OF THIS LANGUAGE? >> I THINK IT WORKS. IN PARTICULAR THE LAST--SO 55-57, YOU KNOW IT TALKS ABOUT THAT THEY MAY BE IDEBT FIELD FUNCTIONSABLE OR MAY NOT BE AVAILABLE, THAT RESEARCHERS ARE OBTAINING INFORMATION ABOUT THEM. SO I THINK THOSE 2-POINTS WOULD COVER WHAT I WAS THINKING THOUGH, AND? , AND YOU'RE OKAY WITH THEM NOT BEING SO THIS DOCUMENT FROM CONSIDERATION HERE. >> I WILL SCROLL FOR A SECOND, I THOUGHT WE ADDED THEM AS AN EXAMPLE OF-- >> OKAY. >> --A SCENARIO OF PEOPLE THAT WERE-- >> OKAY, THIS IS SUPPOSED TO BE A COUPLE OF EXAMPLES BECAUSE I THOUGHT WE DIDN'T DO--DIDN'T WE DECIDE NOT TO DO THE RESEARCH TEAM. >> I THOUGHT I HAD SENT EXAMPLES TO DAVID. SO MAYBE THAT'S--YEAH,. >> AT LINE 200 WE TALK ABOUT THE WEARABLES AND THINGS,. >> YES. >> AND I WILL SAY STEPHEN, I WILL GO BACK UP NOW, SORRY ABOUT THE EYEBALL WHIPLASH, BUT WHEN WE PUT THE SECONDARY SUBJECTS INTO AN EXCLUSION, I MEAN WE'VE--AT LEAST SOME OF US THAT WERE LOOKING AT IT, WERE REALLY THINKING ABOUT THE OLD VCU CASE FROM I FORGET HOW MANY YEARS BACK WHERE PEOPLE WERE COMPLETING QUESTIONNAIRES WITH SENSITIVE INFORMATION ABOUT PARENTS, I THINK IT WAS OR SOME OTHER FAMILY MEMBERS AND THAT LED TO THE WHOLE RISE OF THE SECONDARY SUBJECT CONSIDERATIONS. THIS WAS NOT WRITTEN WITH WEARABLES IN MIND WHICH IS WHY IT ENDS UP BEING A DIFFERENT KIND OF--I THINK THOSE ARE POTENTIALLY DIFFERENT NUANCE BUT DIFFERENT TYPES OF SECONDARY SUBJECTS. >> THIS KIND OF INFORMATION IS ACTIVELY COLLECTIVE AS OPPOSED TO WEARABLES OR BODY CAMS OR WHATEVER, COLLECT INFORMATION THAT'S INCIDENTALLY INVOLVED. >> RIGHT. >> ANY OTHER HANDS HERE, STEPHEN? >> JANET HAS HER HAND UP. >> I WANT TO MAKE SURE I UNDERSTAND YOU. IN A SITUATION WHERE SAY, IN AUTISM RESEARCH WHERE THEY'RE TRIKING TO TRACK VARIOUS FAMILY MEMBERS WHO MIGHT HAVE HAD IT IN THE PAST, THE RESEARCH SUBJECT WHO HAS GONE THROUGH CONSENT MAY BE ENTERING INFORMATION ABOUT PARENTS OR RELATIVES BUT NONE OF THOSE PEOPLE WERE CONSENTED. IS THAT WHAT THIS PARAGRAPH IS TALKING ABOUT? FIFTY-ONE THROUGH 58? >> I THINK SO. >> DAVE IS THAT YOUR UNDERSTANDING? >> JUDGES. >> THAT'S EXACTLY WHAT IT'S DONE. >> OKAY, THANK YOU. OKAY. LET'S KEEP GOING. >> ALL RIGHT, THE NEXT SECTION SHOULD BE LESS CONTROVERSIAL, SO WE THEN GO INTEREST A DISCUSSION OF THE REGULATORY PARAMETERS AROUND THESE CONSIDERATIONS. THIS IS LONGER THAN BEFORE BECAUSE WE HAD IT SPLIT UP IN A FEW AREAS BUT THERE'S--THERE'S--I DON'T THINK THERE'S ANYTHING HERE THAT'S SURPRISING BECAUSE IT'S QUOTING REGGULESES AND THEN TALKING ABOUT WHAT THAT MEANS SO IT STARTS OFF BY TALKING ABOUT THE 111, CRITERIA FOR APPROVAL AND WHERE RISKS ARE MENTIONED AND THEN AT LINE 74 CLRIFYS THAT THIS DOESN'T REQUIRE THEM TO CONSIDER RISKS TO NON--IT DOESN'T EXPOLICE THELY REQUIRE RISKS TO NONSUBJEBTS BEING PART OF THE CRITERIA FOR APPROVAL. BUT DOESN'T PROHIBIT IT EITHER AND I NOTE THAT YOU KNOW THAT'S JUST THE WAY THE REGULATIONS ARE WORDED. IT'S RISK TO SUBJECTS AND DOESN'T TALK ABOUT NONSUBJECTS. >> LINE 78, IT SIMPLY TALKS ABOUT YOU KNOW MAKING CHANGES THAT ARE RELATED TO HAZARDs, AGAIN TO THE SUBJECTS WITHOUT ANY MENTION OF OTHERS AND THEN STARTING AT LINE 87, WE GIVE INTO THE UNANTICIPATED PROBLEM LANGUAGE BECAUSE THIS REALLY IS THE PLACE WHERE WE--THAT INFORMATION OR HOW TO ACT ON IT, THIS IS A REGULATION THAT TALKS ABOUT REPORTING THAT THE IRB REVIEWED THESE THINGS, IT, YOU KNOW IT JUST SORT OF APPEARS IN THE REGULATION OF THIS 1 AREA AND THAT'S WHAT THE PARAGRAPH AT 96 POTENTIALLY SAYS IS THAT REGULATIONS--JUST SAY IRBs HAVE TO REPORT IT BUT IT DOESN'T TEL THEM WHAT TO DO WITH THE INFORMATION ITSELF, ALTHOUGH ON THE LAST 3 LINES, IN THE MIDDLE OF 98 THRU 100, YOU KNOW WHEN YOU IRBs AND THIS IS--I GUESS I HAVE TO CALL ANECDOTAL BUT IRBs ARE GETTING THESE THINGS AND THEY ADDRESS THEM WHEN REPORTED EVEN IF THE HARMS DIDN'T DIRECTLY INSOLVE SUBJECTS, I'M NOT AWARE, OF IT BUT THAT'S GREAT AND WE WILL IGNORE IT BUT IT IS SORT OF EXTRA REGULATORY AT THAT POINT BECAUSE THERE'S NO REQUIREMENT THAT THE IRB DO ANYTHING TO ACT ON IT. AND WE DID WORK ON THIS SECTION TO MAKE LANGUAGE ABOUT WHAT RIERKS RBs ARE ALLOWED TO DO OR NOT ALLOWED TO DO AND THAT'S BEEN CAUGHT BY THE COMMITTEE SO ANY COMMENTS ON THE REGULATORY SECTION? I'M GUESSING NOT THEN, SO I WILL MOVE ALONG AND THEN THE NEXT SECTION, SO 1 OF THE THAT WE'VE BEEN SUBCOMMITTEES WERE PRESSED TO CONSIDER IS, YOU KNOW WHAT IS THE ETHICAL PARAMETERS THAT MIGHT BRING THIS INTO CONSIDERATION FOR THE IRB EXCLUSIVELYOT REGULATIONS, SO THESE SECTIONS IS PRETTY NEW, SEEN BY THE SUBCOMMITTEE BUT NOT A LOT OF CHANGE WAS RECOMMENDED AND THAT YOU KNOW HERE WE TURN AND LOOKED TO THE BELMONT REPORT AND NOTE THAT YOU KNOW IT DOES ACKNOWLEDGE THAT RISKS AND BENEFITS OF RESEARCH GO BEYOND THE INDIVIDUAL SUBJECTS AND USE THAT AS AN ARGUMENT TO SAY WHY IT WOULD BE REASONABLE TO CONSIDER FOR IRBs TO HAVE THESE CONSIDERATIONS AS WELL. >> I HAVE A QUESTION, DAVE, YOU QUOTE THE BELMONT REPORT IN THE SAME SENTENCE TWICE SO I THINK YOU CAN DO SOME EDITING TO MAKE IT A BIT TIGHTER. >> YES, THANK YOU. >> AND THEN MY QUESTION IS I DIDN'T LOOK BACK TO SEE WHERE, UNDER WHAT PRINCIPLE IS THIS OBSERVATION MADE IN THIBLE MOBT REPORT? IF ANY? >> I DON'T REMEMBER IF IT'S IN THE SECTION ON THE PRINCIPLES ITSELF, I APOLOGIZE. >> I WILL TAKE A QUICK PEEK BECAUSE I DO THINK IT WILL BE INTERESTING TO SEE IF THEY LINK IT MORE TO THE PRINCIPLES SO I WILL GOOGLE IT AND LOOK AT IT MYSELF WHILE WE'RE LISTENING. >> SO DAVID JUST OCCURS TO ME THAT THE CONCISE STATEMENT OF THE PROBLEM HERE IS THE AUTHORITY OF THE IRB TO APPROVE, DISAPPROVE OR REQUIRE CHANGES ABOUT YOU THOSE ARE EXPLICITLY BASED ON THE 111 CRITERIA WHICH DOESN'T INCLUDE RISKS TO BYSTANDERS SO THAT'S SORT OF IT. SO IT'S GOING TO BE LIKE THE JUSTICE PIECE. WHETHER YOU KNOW IT WILL GO BEYOND THE EXPLICIT LANGUAGE OF THE 111 QUICKLY. SKIP, IS YOUR HAND STILL UP? LESLIE AND THEN KEVIN. >> SO 1, I JUST QUICKLY LOOKED AND IT IS UNDER ASSESSMENT OF RISKS AND BENEFITS IN THE BELMONT REPORT THAT LINE THAT SKIP WAS TALKING ABOUT THE OTHER THING I HAD WAS JUST ON 112-113, HAVE YOU A SENTENCE ABOUT SETTING THE BAR FOR ENGAGEMENT AND MORE JUST I THOUGHT MAYBE SETTING THE PARAMETERS CONNOTATION WISE I JUST THOUGHT OF THAT AS THE HURDLE, GETTING OVER IT KIND OF THING, IT'S A VERY MINOR POINT BUT IT JUST STRUCK ME WHEN READING IT. >> I WILL NOT COMMUNICATE THIS WELL BUT WITH CONCERN ABOUT ETHICAL CONCERNS WHEN IT TALKS ABOUT MISSION CREEP AND THE NEXT SECTION DISCUSSES HOW THAT IS DISCOURAGED AND IT JUST FELT TO ME LIKE THE ETHICAL PARAMETERS EXAMINED WERE WERE MAYBE NOT BROAD ENOUGH, WHAT ARE THE RISKS THAT THE IRB DOESN'T DO IT, WHAT ARE THE RISKS OF IRBs BECOMING OVER TAXED AND MAYBE MY CONFUSION IS ABOUT THE FRAMING OF THE CHARGE FOR THIS PARTICULAR DOCUMENT, YOU KNOW SPECIFICALLY ASKING ABOUT WHAT ROLE THE IRBSHOULD PLAY, BUT THEN THIS IS THE ASSUMPTION THAT THE RESOURCES AVAILABLE TO IRBs AND THE RULES GOVERNING THEM SHOULD REMAIN STATIC AND THOSE CAN'T BE MOVED IN THIS DOCUMENT OR THIS DOCUMENT SUPPOSED TO CONSIDER WHAT COULD BE DONE. SO THERE'S JUST--IT SEEMS LIKE THERE ARE BROADER ETHICAL ISSUES REGARDING DIFFERENT TYPES OF COSTS THAT MIGHT BE RELEVANT. I FEEL LIKE THAT--I ONLY UNDERSTAND ABOUT 80% OF WHAT I JUST SAID SO OPOLOGYS. >> SO KEVIN, DAVE, TELL ME IF I GOT THIS WRONG BUT I WILL CHANNEL THE SUBCOMMITTEE TO SOME EXTENT SO I THINK THERE IS AN UNSPOKEN ASSUMPTION THAT IRBs THAT ARE BEING DISCUSSED HERE IS THAT IRBRKSZs TAKE THIS ON WITH THE CURRENT INSTRUCTURE AND RESOURCES MOSTLY BECAUSE IT WASN'T FELT AND I DON'T THINK THAT'S UNJUSTICIFIED FROM WHERE THE SUBCOMMITTEES WERE COMING FROM, I THINK THE FEELING WAS THIS WAS NOT A HUGE PROBLEM FROM THE PEOPLE WHO SERVE ON IRBs AND RUN IRBs, THIS IS A PROBLEM IN SPECIFIC CIRCUMSTANCES AND IN FACT, THERE WAS A LARGE COMPONENT OF THE SUBCOMMITTEES WHO FELT LIKE THIS DIDN'T EVEN NEED TO BE ADDRESSED BECAUSE THEY ALREADY WERE SENSITIVE TO IT AND DID IT ROUTINELY WHEN THEY DISCUSSED THE DESIGN AND RESEARCH STUDIES OR THERE WERE OTHER COMMITTEES THAT DID IT WHICH REPORTED THEIR FINDINGS TO THE IRB, AND MANY PEOPLE DIDN'T WANT TO MAKE CHANGES AND MANY PEOPLE FELT LIKE WE SHOULD NOT TAKE THIS ON BECAUSE IT WAS LARGE. >> OKAY? , >> SO I THINK--YOU KNOW IT DEPENDS OW EXPENSE OF WE GET BUT YOU RAISED 1 OF THE TROUBLING ISSUES OF THIS IS EVERYBODY'S AFRAID THAT IF WE CREATE POOLS AND CHECK LISTS THAT OTHER IRBs WILL HAVE TO DO, IT WILL BE ADDING TO THEIR BURDEN AND MOST PEOPLE FELT THAT THAT WAS NOT WORTH WHILE NOT BECAUSE IT WAS NOT EGHTECLY NECESSARY OR ANYTHING LIKE THAT, OR THAT PEOPLE WERE BEING HARMED, BUT JUST BECAUSE IT WASN'T A PROBLEM RIGHT NOW. SO I THINK THAT'S, YOU KNOW SOMETHING WE HAVE TO DEAL WITH. I HAVE A COUPLE MORE HANDS UP AND THEN I WILL ASK IF PEOPLE WANT TO--SO WE HAVE A BREAK SCHEDULED AT 12:45, THAT'S OUR ONLY TIME TO GRAB SOME LUNCH AND ANOTHER CUP OF COFFEE. I WAS GOING TO STOP EARLY AND THIS TOPIC IS ON THE AGENDA AGAIN, AT 3:15. SO I'M INCLINED TO TAKE THE CURRENT QUESTIONS AND THEN WRAP IT UP, RECONVENE AT 1 FOR THE JUSTICE DISCUSSION IF THAT'S AGREEN CELLSABLE TO PEOPLE. DAVE, DOES THAT WORK FOR YOU? SO WE ASK SKIP AND JODI HAVE THEIR HANDS UP SKIP, YOU'RE MUTED. >> I WANT TO MAKE A QUICK COMMENT. >> JODI? >> SO DAVID, I DON'T KNOW IF THIS IS SOMETHING THAT WILL COME TOWARDS THE END OF THE DOCUMENT BUT ARE WE THINKING OF PROVIDING ANY GUIDANCE FOR INVESTIGATORS AS WELL, SO I'M THINKING ABOUT QUESTIONS THAT COME UP WHEN WE CALL SOMEBODY A NONSUBJECT AND I'M THINKING OF QUESTIONS LIKE, OKAY, WHO IS A NONSUBJECT, ARE THOSE OTHER FAMILY MEMBERS THAT SOMETHING FOR LIKE AN HOUR AND HAPPENS TO HAVE--JUST AS ETHICAL PROVIDERS OR GUIDANCE FOR SOME INVESTIGATORS. IT'S SOMETHING TO THINK ABOUT. >> YEAH, I CAN'T REMEMBER IF THAT CAME UP IN THE LAST SACHRP MEETING OR IN 1 OF THE SUBCOMMITTEE CALLS BUT THERE WAS SOME QUESTION ABOUT WHETHER, YOU KNOW IF IT'S APPROPRIATE TO FOCUS ON THE IRB, I THINK 1 OF THE CHALLENGES IN THINKING ABOUT BROADENING IT TO LIKE SOME FDA GUIDANCE WILL SAVE THIS GUIDANCE FOR INVESTIGATORS AND IRBs, BROADENING IT INCREASES THE CHALLENGES OF US FALLING DOWN A HOLE THAT MAKE ITS UNMANAGEABLE BUT IT'S A VALID POINT. >> SKIP? >> YEAH, I WAS JUST LOOKING AT THE QUOTATION FROM THE BELMONT REPORT AND AND AS KEVIN WAS TALKING, I WAS THINKING, THERE'S NOT MUCH ACTUALLY SAID HERE ABOUT THE ETHICS OTHER THAN QUOTING AN ARTICLE BY JONATHAN KIMMELMAN AND THEN QUOTING THE BELMONT REPORT SO I THINK WE NEED TO SAY MORE BUT THEN IN ASKING MYSELF ABOUT THOSE QUESTIONS I'M LOOKING AT THE QUOTE AND THIS ISSUE OF SOCIETY AT LARGE, I GUESS THERE'S 2 TENSIONS, 1 IS HOW MUCH IT GETS INTO THE DISCUSSION OF GROUP HARMS THAT ARE GOING TO FINESSE IN THIS DOCUMENT BUT THEN I'M ALSO REMINDED IN LOOKING AT THE CRITERIA, THAT THE IRB IS NOT SUPPOSED TO APPLY LONG RANGE EFFECTS OF THE KNOWLEDGE GANNAD IN RESEARCH WHICH TO SOME EXTENT IS THE MECHANISM BY WHICH SOCIETY AT LARGE IS AFFECTED UNLESS WE YOU KNOW TRIGGER SOME SORT OF CATASTROPHIC EVENT FROM THE RESEARCH ITSELF, SO I'M STRUCK MORE BY THE COMPLEXITY OF THINKING ABOUT THESE FEW SENTENCES. I'M SURE HOW TO FIX IT, BUT, I DON'T THINK WHAT'S SAID HERE REALLY DOES ENOUGH IN PROVIDING ANY SORT OF ETHICAL FRAMEWORK AROUND THIS PARTICULAR TOPIC. SO JUST SOME THOUGHTS. SO IT CAME OUT BETWEEN THE LAST MEETING AND THIS 1. IT'S WORTH WHILE. IT REITERATES MANY OF THE PARTS OF THE THING WE WERE DISCUSSING ALTHOUGH I DON'T THINK HE TALKS ABOUT [INDISCERNIBLE] AS I RECALL BUT HE GIVES A VERY NICE EXPLICATION OF THE PHYSICAL HARMS WE THOUGHT WE WERE DEALING WITH WHEN WE STARTED THIS. SO DAVE IF YOU WERE HOPING FOR AT ALL ODDS IF ARE THIS TO COME TO A VOTE TODAY, I DON'T THINK SO. >> OH NO, I HAD NO SUCH HOPE. NO. >> BUT THANK YOU ALL. WE WILL RESTART THIS DISCUSSION WHEN WE'RE DONE WITH THE JUSTICE PANELS AND JUSTICE PANEL AND DISCUSSION, SO AT 3:15, IF NOT BEFORE AND OBVIOUSLY THERE'S A LOT TO STILL DISCUSS. AND FOR NOW, WE WILL GO ON PAUSE FOR 23 MINUTES. GRAB A CUP OF COFFEE AND SOME LUNCH AND WE WILL SEE YOU BACK IN A FEW. >> THANK YOU ALL, WELCOME BACK, I HOPE YOU HAD A CHANCE TO HAVE SOMETHING TO EAT AND WE'RE GOING TO JUMP RIGHT IN TO GET BACK TO JUSTICE, SO I THINK THAT SOME OF THE DISCUSSION WE HAD BEFORE LUNCH ON BYSTANDER RISK--IS A CONCERN AND I WILL MAKE A COUPLE REMARKS BEFORE INTRODUCING OUR PANEL AND I KNOW THAT DR. OROJO WANTED TO MAKE SOME REMARKS FROM THE FDA. SO I THINK THIS IS A VERY LARGE AND TIMELY ISSUE AND I THINK SACHRP IS CHALLENGED TO BOTH COME UP WITH THE RECOMMENDATIONS IN THE DOCUMENT THAT DOES JUSTICE--FORGIVE THE--IT WAS NOT INTENDED TO BE A PUN BUT ACKNOWLEDGES THE DEPTH OF THIS ISSUE AND IT'S IMPORTANTS BUT IT DOES SHY AWAY FROM CONCRETE RECOMMENDATIONS, SO FOR US LEND OUR VOICE TO THE MANY RAISED NOW ABOUT JUSTICE CONCERNS IS IMPORTANT BUT I ALSO THINK WE HAVE AN OPPORTUNITY TO TRY TO FIND WAYS TO MAKE THIS REAL FOR OUR COMMUNITY. SO, WE'RE NOT EXPECTING TO HAVE THIS DOCUMENT OBVIOUSLY CONCLUDED TODAY. I THINK THIS IS GOING TO BE AN ONGOING CONVERSATION. AND I KNOW ON THE PANEL TODAY WE WILL HEAR FROM PEOPLE WHO HAVE SOME CONCRETE RECOMMENDATIONS. SO I LOOK FORWARD TO THAT DISCUSSION, BUT BEFORE WE START WITH THE PANEL, I WOULD LIKE TO CALL ON ADMIRAL ORJO, I HOPE I PRONOUNCED THAT CORRECTLY, ASSOCIATE COMMISSIONER MINORITY HEALTH, DIRECTOR OF THE OFFICE OF MINORITY HEALTH AND HEALTH EQUIT NEUROECTODERMAL THE OFFICE OF THE FDA COMMISSIONER, ADMIRAL? YOU'RE MUTED. >> HOPEFULLY CAN YOU HEAR ME, CAN YOU HEAR ME NOW? >> YES. >> THANK YOU. >> WONDERFUL. THANK YOU VERY MUCH. I REALLY APPRECIATE THE OPPORTUNITY TO BE ABLE TO BE HERE TODAY WITH EVERYONE AND OF COURSE REALLY LOOKING FORWARD TO HEARING THE PANEL DISCUSSION ON THE TOPIC AND WE REALLY WANTED TO JUST GIVE A BRIEF UPDATE TODAY LEADING INTO THE PANEL DISCUSSION IF YOU HIGHLIGHT THE WORK THAT THE FDA HAS BEEN DOING SPECIFICALLY AREA OF CLINICAL TRIAL DIVERSITY AT THE NUMBER OF FAMILIAR FACES AND NUMBER OF PEOPLE THAT WE'VE BEEN ABLE TO WORK WITH TO ADVANCE DIVERSE PARTICIPATION AND WANTED TO REALLY HIGHLIGHT THAT FOR THE GROUP TODAY AND JUST BY WAY OF BACKGROUND, OF COURSE FDA ESTABLISHED THE OFFICE OF MINOR HEALTH AND HEALTH EQUIT NEUROECTODERMAL 2010, WE WORK BROADLY ACROSS OUR AGENCY TO PROTECT THE HEALTH OF DIVERSE POPULATIONS BY FOCUSING ONURE OUR EFFORTS IN 2 AREAS AND RESEARCH AND COMMUNICATION THAT WORKS TOWARDS ADDRESSING HEALTH DISPARITIES AND OF COURSE CENTRAL TO THAT MISSION IS WORKING TO ADVANCE THE PARTICIPATION OF RACIAL ETHNIC MINEARITY GROUPS IN CLINICAL TRIALS AND WE'VE HAD THE OPPORTUNITY TO REALLY DO A LOT OF WORK IN THIS SPACE. I THINK IT'S ALWAYS IMPORTANT WHEN WE TALK ABOUT CLINICAL TRIAL DIVERSITY TO HIGHLIGHT OUR MOST RECENT KIND OF SIGNIFICANT LEGISLATION IN THIS SPACE, WHICH IS THE 2012--BIOLOGICS AND DEVICES AND ULTIMATE GOAL PLATELY WE ISSUED OUR DATA PLAN WHICH FOCUSES ON QUALITY, PARTICIPATION AND TRANSPARENCY AND WE HAVE WORKED TO HOST PUBLIC MEETING, DEVELOP TOOLS, ISSUE GUIDANCE DOCUMENTS TO SUPPORT DIVERSE PARTICIPATION IN CLINICAL TRIALS. I KNOW MANY OF YOU HERE ARE WITH THE DOCUMENTS BUT TO HIGHLIGHT A FEW OF THOSE, WE HAVE OUR 2016 GUIDANCE THAT FOCUSED ON COLLECTION OF RACE AND ETHNICITY DATA AND CLINICAL TRIALS, THIS GUIDANCE WAS IMPORTANT BECAUSE IT REALLY REAFFIRMED AND HIGHLIGHTED THAT EXPECTATIONS ARE THAT SPONSORS AND ROLE PARTICIPANTS BHO REFLECT THE DEMOGRAPHICS FOR RELEVANT POPULATIONS WITH REGARD TO AGE, GENDER, RACE AND ETHNICITY. WE HAD OUR 2017 GUIDANCE DOCUMENT THAT FOCUSED ON EVALUATION AND REPORTING OF AGE, RACE, AND ETHNICITY SPECIFIC DATA DEVICE STUDIES AND THEN FAST FORWARD TO THE 2017 REAUTHORIZATION ACT IN RESPONSE TO THIS, THE AGENCY ISSUED OUR MOST RECENT DRAFT GUIDANCE, THIS CAME OUT IN JUNE 2019 AND IT'S FOCUSED ON ENHANCING THE DIVERSITY OF CLINICAL TRIALS POPULATIONS, ELIGIBILITY CRITERIA AND ENROLLMENT PRACTICES AND TRIAL DESIGN AND THIS GUIDANCE IS REALLY IMPORTANT BECAUSE IT FOCUSED ON BROADENING ELIGIBILITY CRITERIA, AVOIDING EXCLUSIONS FOR CLINICAL TRIALS AND WORKING TO IMPROVE TRIAL RECRUITMENT SO THAT PARTICIPANTS ENROLL INDEED TRIALS BETTER REFLECT THE POPULATION, MOST LIKELY TO USE THE DRUG IF THE DRUG IS APPROVED OF COURSE WHILE MAINTAINING SAFETY AND EFFECTIVENESS STANDARDS SO THAT'S JUST KIND OF A QUEK HIGHLIGHT OF THE GUIDANCE DOCUMENT THAT WE'VE ISSUED, OF COURSE, DURING THE COVID-19 PANDEMIC WE HAVE CONTINUED TO WORK TO RAISE AWARENESS AROUND THE IMPORTANCE OF DIVERSE PARTICIPATION IN CLINICAL TRIALS AND WE HAVE GUIDANCE DOCUMENTS THAT HAVE BEEN ISSUED SPECIFIC TO COVID-19 THAT HIGHLIGHT THIS, FOR EXAMPLE, WE HAVE THE GUIDANCE FOR INDUSTRY ON DEVELOPMENT AND LICENSURE VACCINES TO PREVENT COVID-19, THIS GUIDANCE STATES THAT FDA STRONGLY ENCOURAGING THE ENROLLMENT OF POPULATIONS MOST AFFECTED BY COVID-19 SPECIFICALLY RACIAL AND ETHNIC MINORITIES, ANOTHER GUIDANCE DOCUMENT THAT I WANT TO HIGHLIGHT ABOUT THOSE, IS COVID-19 GUIDANCE FOCUSED ON DEVELOPING DRUGS AND BIOLOGICAL PRODUCTS FOR TREATMENT OR PREVENTION. AND THIS GUIDANCE ALSO STATES THAT RACIAL AND ETHNIC MINORITY PERSONS SHOULD BE REPRESENTED IN TRIALS AND IT GOES ON TO INSURE THAT CLINICAL TRIALS SITES INCLUDE GEOGRAPHIC LOCATIONS WITH THE HIGHEST CONCENTRATION OF MAICIAL AND ETHNIC MINORITIES TO RECRUIT A STEADY DIVERSE POPULATION. THE OTHER THING THAT IS IMPORTANT TO HIGHLIGHT, OFF OFFICE WITHIN THE OFFICE OF HEALTH MINORITY INEXPECTATIONS QUIT SKPE BAKUGAN IN RESPONSE TO DAJA, WE DEVELOPED A AN INITIATIVE AND THAT IS TO RAISE AWARENESS AROUND THE PERSON OF RACIAL AND ETHNIC MINORITY IN CLINICAL TRIALS, ONGOING CAMPAIGN THAT PROVIDES POSITIVE REINFORCEMENT TO EDUCATION AND MULTIMEDIA TWORK TOWARDS ADDRESSING THE BARRIERS PREVENTING DIVERSE GROUPS FROM PARTICIPATING IN CLINICAL TRIALS THROUGH A VARIETY OF DIFFERENT CULTURALLY AND LINGUISTICALLY CONFIDENT TOOLS, STRATEGIES AND RESOURCES. ALL OF THIS IS AVAILABLE ON OUR WEBSITE, WE DEVELOPED EDUCATION MATERIALS IN MULTIPLE LANGUAGES, FACT SHEETS, BROCHURES, VIDEOS, PUBLIC SERVICE ANNOUNCEMENTS, ENGAGED IN SOCIAL MEDIA OUTREACH, WE HAVE A DEDICATED WEBPAGE INCLUDING A COMMUNICATIONS TOOL KIT WITH ALREADY PREPARED SOCIAL MEDIA MESSAGES FOR OUR STAKEHOLDERS BUT I THINK THE OTHER PART TO THIS CAMPAIGN THAT'S BEEN REALLY IMPORTANT FOR US IS INSURING THAT WE ARE REALLY ENGAGING DIFFERENT COMMUNITIES AND HEALTH PROFESSIONALS TO HIGHLIGHT AND PROVIDE EDUCATION ON THE IMPORTANCE FOR DIVERSE PARTICIPATION AS WELL AS BOTH COLLABORATIONS ACROSS GOVERNMENT FROM BOTH PUBLIC AND PRIVATE SECTOR STAKEHOLDERS AMONG OTHERS AND ADDING THE STAKEHOLDER PIECE IS REALLY IMPORTANT BECAUSE WHEN WE LOOK AT BARRIERS TO PARTICIPATION THOSE BARRIERS CROSS MULTIPLE SECTORS AND BEING ABLE TO COLLABORATE AND WORK TOGETHER OF COURSE, WE THINK THAT'S VERY IMPORTANT TO TRY TO CONTINUE TO WORK AND PARTIARASIPATION IN CLINICAL--PARTICIPATION IN CLINICAL TRIALS AND KNOWING THAT BARBARA IS GOING TO SPEAK IN A BIT, I WANT TO HEIGHT LIGHT THAT 1 OF OUR STAKEHOLDER ACTIVITIES WAS BEING ABLE TO PARTICIPATE IN THE MRCT AT HARREGARD, LARGE DIVERSITY WORKING GROUP THAT INCLUDED FDA, INDUSTRY AND ACADEMIA AND OTHERS AND WHERE THEY ULTIMATELY ISSUED THE GUIDANCE DOCUMENT, I KNOW BARBARA WILL TALK ABOUT THIS THAT'S FOCUSED ON ACHIEVING DIVERSITY AND EQUITY IN CLINICAL RESEARCH, THOUGH, THAT WAS A GREAT OPPORTUNITY FOR US TO BE ABLE TO PARTICIPATE AND BE A PART OF THAT, I SAW LINDA ON THE VIDEO AS WELL AND WE'VE BEEN ABLE TO WORK ALSO WITH YALE AND THE CULTURAL AMBASSADOR PROGRAM FROM A COMMUNITY ENGAGEMENT PERSPECTIVE DISP WE ARE LOOKING FORWARD TO DIVERSE PARTICIPATION, SO, TO ADVAPS PARTICIPATION AND CLINICAL TRIALS AND ULTIMATELY DATA THAT'S SUBMITTED TO FDA AND THANK YOU SO MUCH FOR HAVING THE OPPORTUNITY TO GIVE A BRIEF HIGHLIGHT OF THE ACTIVITIES AND THE WORK THAT WE'VE BEEN DOING AND I LOOK FORWARD TO BEING ABLE TO LISTEN TO THE PANEL DISCUSSION, THANK YOU. >> THANK YOU. THAT WAS ALSO A CONTEXT AND ALSO ENERGIZES US WITH WHAT'S POSSIBLE, SO AGAIN, THANK YOU. THE WAY IT WILL WORK IS EACH PANELIST WILL HAVE 15 MINUTES TO PRESENT AND THEN WE WILL OPEN IT TO DISCUSSION, I WILL WATCH THE TIME. I THINK WE ARE SCHEDULED TO END AT--THIS DISCUSSION AT 3 WHICH MAY BE AMBITIOUS BUT I WANT TO SAVE TIME AT THE END FOR COMMENTS ON THE DRAFT DOCUMENT. SO FOR OUR PANELISTS TODAY WE WILL START WITH DR. OWEN GARRETT, SOME OF YOU LONG TIME SACHRP MEMBERS ACCIDENT PROBABLY NONE OF YOU SENTENCE HE WENT OFF THE COMMITTEE BEFORE I WAS CHAIR WHICH MEAN ITS WAS A WHILE AGO, MAY BE FAMILIAR WITH OWEN. OWEN IS THE PRESIDENT AND CHIEF EXECUTIVE OFFICER OF BRIDGE CLINICAL RESEARCH WHOSE MISSION IS TO INCREASE DIVERSITY IN CLINICAL TRIALS. HE HELPED LAUNCH MULTIPLE COLLABORATIVE EFFORTS IN ADVANCING PRECISION MEDICINE WERE AND DATA SCIENCE. HE SERVES AS AN ADVISOR TO THE STANFORD PERSONAL HEALTH AND I--TO IMPROVE THE HEALTH OF UNDERSERVED AND ETHNIC RACIAL GROUPS. HE'S A STANFORD CO-INVESTIGATOR USING GENETIC TESTING KITS EXPLORING WHY MINORITY PATIENTS MAY OR MAY NOT PARTICIPATE WITH GENETIC TESTING AND AWARDEE FOR PRONL ECTOMYOSINS FOCUSED ON THE WILLINGNESS OF PATIENTS WITH SICKLE CELL DISEASE TO PARTICIPATE IN PREMEDICINE RESEARCH. THESE ALSO A NATIONALLY RECOGNIZED LEDDER IN THE FIELD OF RESEARCH AND RESEARCH ETHICS. HE WAS AS I NOTED ON SACHRP BETWEEN 2012-2016. HE CO-AUTHORED ADMINISTRATE DOCUMENTS AROUND BIOSPECIMEN DATA SECURITY AND PATIENT ENGAGEMENT RESEARCH AND COWERRENTLY SERVES ON THE BOARD OF PROFESSIONAL SCIENTIFIC RESEARCH. WHICH OF YOU ARE FAMILIAR. AND THERE'S ALSO A BIODIVERSITY INFORMATION IN THE PACKET ON RESEARCH OUTCOMES AND THAT WAS PRECEPTED FOR THOSE OF WHO YOU ARE BRAIN LISTENERS ON THAT NPR PODCAST. WELCOME, OWEN. >> THANK YOU . >> SO I DON'T KNOW THAT I WILL GET YOUR NAME RIGHT IN TERMS OF PRONOUNCUATION BUT-- >> RUQAIJAH, YEARBY. >> I APOLOGIZE, PROFESSOR OF LAW AND MEMBER CENTER FOR HEALTH LAW STUDIES. CO DIRECTOR SAINT LOUIS UNIVERSITY OF FOR HEALING JUST INEQUIT AND SHE'S A SPECIALIST IN HEALTHCARE INJUSTICE IN MEDICAL RESEARCH AND IS PUBLICKED AND TAUGHT EXTENSE OFLY IN NEEZ AREAS AND I HAVE TO SAY, YOU KNOW 1 OF THE--WHEN WE WERE LOOKING FOR PEOPLE TO PUT--TO ASK I SHOULD SAY TO BE ON THIS PANEL, JUST READING HER BIBLIOGRAPHY MADE IT IMMEDIATELY CLEAR HOW TOPICAL HER PERSPECTIVE WOULD BE TO OUR ISSUES TODAY. LASTOT PANEL IS DR. BARBARA BIERER, FOR THOSE IN THE SMALL GROUP WHO DON'T ALREADY KNOW BARBARA SHE'S A HEMATOLOGYST, ONCOLOGIST AT BRIGMEDICARE AND MEDICAID MEDICAL SCHOOL AND HARVARD, AND DIRECTOR OF POLICY FOR SMART IRB, PROBABLY MOST RELEVANT FOR TODAY'S DISCUSSION, SHE CONFOUNDED AND LEADS MRCT, AND CLINICAL TRIALS CENTER, AT BRIGHAM WOMEN'S CENTER WHICH IS I COLLAB RAIVE EFFORT TO IMPROVE STANDARS FOR THE PLANNING AND CONDUCT OF INTERNATIONAL CLINICAL TRIALS. YOU KNOW FROM MY PERSPECTIVE, 1 OF THE UNIQUE THINGS ABOUT MRCT IS THAT IT INVOLVING REPRESENTATIVES FROM ALL THE STAKEHOLDERS IN THE CLINICAL TRIALS ENTERPRISE. SO FROM REGULATORS, PHARMACEUTICAL COMPANIES, CROs, ACADEMIA AND PATIENTS, AND THEY HAVE ARE RECENTLY DEVELOPED AGAIN WE WERE TRYING TO GET THIS OUT. --COPIES OF WHICH WERE DISTRIBUTED AND WHICH I EXPECT TO BE MUCH OF WHAT BARBARA TALKS ABOUT TODAY. SO AGAIN, I WILL GIVE EACH PANELIST 15 MINUTES AND WE WILL TAKE IT FROM THERE. AND WE WILL START WITH OWEN. >> ALL RIGHT. THANK YOU MUCH. I WILL BEGIN SHARING MY SCREEN. >> CAN YOU SEE THAT. >> YES. >> AND YOU WILL HOLD ME TO THE 15 MINUTES. >> WELL, YES. >> [LAUGHTER] >> SERIOUSLY, I APPRECIATE IT AND I'VE HAD THE BENEFIT OF BENEFIT OF WORKING WITH STEVEN IN MANY, MANY ROLES SACHRP BEING FIRST AND THEN HE TWISTED MY ARM AND I WAS A QUORUM ON THE CHAIR IRB, THEN THEY FIRED ME FROM THE IRB AND I WAS ON THE CORPORATE BOARD OF QUORUM AND HAD A CHANCE TO WORK WITH LINDA AS WELL AND NOW STEPHEN AND I ACTUALLY SERVE ON THE PRIMER BOARD TOGETHER AND I THINK YOU FOLLOWED ME ON TO THE PRIMER BOARD SO THAT WAS A FIRST, SO, WE'RE LIKE A--AN OLD MARRIED COUPLE, WE'VE GONE EVERYWHERE WITH EACH OTHER AND THANK YOU FOR AND INVITING MOOY TO BE PART OF THIS DISCUSSION THAT WE DID THAT LOOKED AT CONCORDANCE AND I WILL HIGHLIGHT SOME OF THAT AND AND TALK ABOUT HOW I THINK IT APLAYS TO THIS NOTION AND ISSUE OF JUSTICE AND RESEARCH AND RECRUITMENT AND RESEARCH, ALL RIGHT? , MY QUESTION ANDA WILL DO THAT SOME POINT INSTEAD OF DURING THE 15 MINUTES. >> YEAH, WE'RE GOING TO TRY TO GIVE EVERYBODY THE FULL LENGTH OF TIME, I THINK WE WILL TRY TO HOLD QUESTIONS UNTIL WE HAVE A DISCUSSION OF THE PANEL AT THE END. SO THIS IS THE DRAFT DOCUMENT--I. >> I DON'T KNOW IF IT'S JUST ME BUT YOU HAVE A BIG GRAY RECK TANGLE? >> HOW ABOUT THAT. >> THAT THERE WE GO. >> THAT IS YOUR VIDEO ACTUALLY, THAT'S THE WEBEX VIDEO, I WILL MOVE THAT,A ROUND. PERFECT. ALL RIGHT. SO FROM TD DOCUMENT, THIS IS A DISTRIBUTION OF BURDENS AND BENEFITS OF RESEARCH SO RIGHT, SHARING THE LOVE OF RESEARCH ACROSS MANY POPULATIONS. SO THE NOTION OF INJUSTICE ARISES FROM THESE BAD THINGS THAT HAPPENING IN SOCIETY WHAT IS IMPLIED IS THESE ISSUES OF BIAS AND INNS TUITIONALLIZED RACISM THAT EXIST IF OUR SOCIETY ARE SOMEHOW OR SOMEHOW INTO THE RESEARCH ENTERPRISE SO IF IT JUST EXITED OUT THERE AND DIDN'T IMPACT US, IT WOULD BE LESS OF AN ISSUE BUT THIS NOTION THAT THESE ARE ISSUES THAT ARE FRANKLY, YOU KNOW MAYBE NOT AS ACUTELY EGREGIOUS BUT CERTAINLY OCCURRING WITHIN THIS RESEARCH ENTERPRISE WITHIN IRBEXPZ WHAT EVERYONE KNOWS RIGHT, BELMONT EXAMINED THIS NOTION OF JUSTICE OR PART OF THE UNDERLYING QUESTION IS, YOU KNOW WAS--DO WE NEED TO MOVE THE PENDULUM A LITTLE DIFFERENTLY. SO BELMONT WRITTEN AND ORGANIZED DURING A TIME WHEN A LOT OF BAD THINGS IN RESEARCH CAME TO LIGHT. RIGHT? AND SO THERE WAS I THINK APPROPRIATELY A MOVE TO PROTECT A CERTAIN GROUP THAT WAS BEING EXPLOITED THAT THAT HAD SOME UNINTENDED CONSEQUENCES AFTER 20, 30, 40, YEARS SO DO WE NEED TO THINK THROUGH AND I THINK THAT THE PART OF THE SENTIMENT IS THINKING THROUGH HOW WE BALANCE THE--YOU KNOW BOTH OF THOSE NEEDS AND MAYBE COUNTER SOME OF THE UNINTENDED CONSEQUENCES MOST NOTABLY WHICH HAVE LED TO AN UNDERREPRESENTATION IN CLINICAL RESEARCH OR RESEARCH BROADLY. SO THIS BACK DROP IS RACISM, SO RACE IS A FIRST GENETIC ANTHROPOETIC LOGIC PHENOMENA WHICH I BELIEVE--SO IF YOU LOOK AT SICKLE CELL DISEASE IT IS PRIMARILY A DISEASE OF THOSE THAT HAVE AFRICAN ANCESTRY AND HAVING SICKLE CELL DISEASE A THOUSAND, 2000, EVEN NOW, YEARS AGO WAS PROTECTIVE AGAINST MALARIA. AND SO MALARIA, THAT MALARIA WILL KILL YOU WHEN YOU'RE MUCH YOUNGER AND IF YOU HAVE SICKLE CELL DISEASE, IF YOU GROW OLDER YOU CAN REPRODUCE, SO THAT LENDS ITSELF TO CONTINUING THAT GENETIC VARIANT IN THE POPULATION AND YOU KNOW OVER THE YEARS THINGS LIKE BOATS AND TRAINS AND PLANES OCCURRED AND THEY MOVE A LOT FASTER THAN OUR GENES CHANGE. RACE IS ALSO A SOCIAL CONSTRUCT AND I THINK THAT IS HIGHLIGHTED IN THE WORKING DOCUMENT AND WHEN THE DOCUMENT TALKS AND HIGHLIGHTS THINGS AROUND THE SOCIAL DETERMINANTS OF HEALTH IT'S ALSO A QUESTION OF PHENOTYPE AND IF YOU LOOK AT ME AND DEPENDING IF YOU HAVE ME ON THE BIG SCREEN OR NOT MOST FOLK WHO IS MET ME WOULD IDENTIFY ME AS A BLACK GUY, RIGHT, BUT INTERESTINGLY, NOT EVERYONE WOULD, RIGHT? I SELF-IDENTIFY AS A BLACK PERSON BUT YOU KNOW, THIS IS REALLY A QUESTION OF PHENOTYPE AND LASTLY, YOU KNOW I KNOW THE CENSUS EITHER CONCLUDED OFFICIALLY A COUPLE DAYS AGO OR MAYBE WE WILL GET ANOTHER CRACK AT IT BUT, FROM THE CENSUS PERSPECTIVE RACE IS A NOTION IS SIMPLY SELF-SELECTION. SO I CAN DECIDE EVERY 10 YEARS THAT I'M BLACK, WHITE, ASIAN, YOU KNOW BY CIRCLING A DIFFERENT BOX ON THE CENSUS FORM. SO THOSE ARE WHAT RACE IS IN DIFFERENT PARTS IN DIFFERENT PERSPECTIVES, BUT THERE IS--WHILE NOT PERFECT, SOME VALIDITY WHILE WE TALK ABOUT BOTH THE ENVIRONMENTAL AS WELL AS BIOLOGIC IMPACTS OF RACE. ALTHOUGH NOT PERFECT. SO LET ME JUMP INTO THE STUDY THAT THE STUDY THAT I WILL TRY TO MOVE THE BIG GRAY BOX,A ROUND. SO THE STUDY THAT WE DID LOOKED AT RACIAL CONCORDANCE, RIGHT? SO THE IMPACT OF HAVING SAME RACE PHYSICIAN ON AND IN THIS CASE BLACK MEN THE WILLINGNESS TO INCREASE UPTAKE OF PREVENTATIVE SERVICES AND WE FOUND THAT YES, ACTUALLY IS A GOOD THING. RIGHT? SO, IF YOU HAVE A BLACK FACTOR AND BLACK GUY WE SAW IN OUR STUDY YOU ACTUALLY MUCH MORE WILLING SURPRISINGLY MORE WILLING TO PREVENTATIVE SERVICES LIKE BLOOD PRESSURE SCREENS, CHOLESTEROL SCREENED, ET CETERA SO A FOLLOW UP RESEARCH QUESTION IS WELL WILL THAT MAKE AN IMPACT ON THE RESEARCH SETTING? SO IN OUR SETTING WE SHOW THAT A CLINICAL SETTING, RESEARCH ENVIRONMENT, REPRESENTING A CLINICAL SETTING THAT THE SAME RACE POSITION HAS THE ABILITY TO IMPACT HEALTH OUTCOMES, CAN YOU HAVE A DIVERSE RESEARCH PI, RESEARCH COORDINATOR, RESEARCH ENTERPRISE POPULATION AND WILL THAT IMPACT RANDOMIZATION, PARTICIPATION AND RESEARCH. SO THAT IS THE BROADER QUESTION, THERE MIGHT BE SOME TRANSFER ENSEL OF SOME OF OUR FINDINGS. ALL RIGHT. SO HERE IS EYE LIGHTS OFURE STUDY, WOMAN IN THE MIDDLE IS MY CO AGHTOR, SHE WAS ON THE FACULTY AT STANFORD WILE DOING THIS RESEARCH, SHE'S IN BARBARA'S NECK OF WOOD, SHE'S AT HARVARD'S KENNEDY SCHOOL, SHE'S A SMART PERSON, SHE'S A ECONOMIST AND A DOC, THERE ARE 3 PEOPLE ON ON HER ON THE PLANET BUT PROBABLY JUST 1 ABOUT BUT A FANTASTIC INDIVIDUAL, AND WE DID OUR EXPRCH WE RECRUITED PRIMARILY FROM BARBER SHOPS IN THE BAY YEAR AND I'LL TALK ABOUT WIDE BAB BERNEA DEET SHOPS AND THE ISSUE OF WHY DID OUR RESEARCH AND WE LOOKEDDA THE BLACK MEN BECAUSE THEY'RE THE SICKEST, CAN BE THE SICKEST SUBGROUP A LOT OF THE EXCESS DEATH ASK CAUSED BY PREVENTIBLE ILLNESS, SUCH AS CARDIOVASCULAR DISEASE ANDNESS KACCTER AND IN THE U.S. CANCER IS BECOMING MORE OF A CHRONIC CONDITION BUT WHILE MANY OF THESE THINGS ARE PREVENTIBLE, BLACK MEN IN PARTICULAR WERE LESS LIKELY TO SEEK PREVENTATIVE CARE AND THIS WASN'T INSURANCE OR LACK OF INSURANCE DOESN'T FULLY AND WE SEE THIS IN LABOR MARKETS AND EDUCATION WHEN PEOPLE IN THE WORKFORCE SEE OTHERS IN LEADERSHIP THAT LOOK LIKE THEM AND YOUNG KIDS AND YOUNG PEOPLE SEE PROFESSORS THAT LOOK LIKE THEM FROM A GENDER FROM A RACE ETHNICITY PERSPECTIVE, YOU KNOW THEY ARE MOTIVATED, LIKELY TO PURSUE INTERESTING CAREERS, CAN SEE THEMSELVES AS LEADERS, SO WE WANTED TO DO--BUT THE RESULTS IN HEALTHCARE WERE A BIT MORE MIXED. ALL RIGHT, SO WE WANT TO DO A STUDY THAT EXAMINED FROM AN IMPERCALIPER SPECTIVE WHETHER OR NOT THIS ISSUE EXIST INDEED HEALTHCARE SO VERY QUICKLY THE STRUCTURE OF THIS WE RECRUITED IN BARBER SHOP AND THE REASON WE RECRUITED IN BARBER SHOPS IS THE REASON THIS SPEAKS TO THE ISSUE OF JUSTICE RIGHT, AND ALWAYS THIS QUESTION WELL, I CAN'T RECRUIT DIFFERENT POPULATIONS AND SO WE WENT TO BARBER SHOPS BECAUSE THERE WAS A WIDE CROSS SECTION OF INDIVIDUALS, SO IF YOU GO TO MY BARBER SHOP, I GO IT A BLACK BARBER SHOP, YOU WILL TO LITERALLY WHO EVER IS NEXT IN LINE, THEY COULD BE AS EDUCATED MORE EDUCATED FROM ME FROM A DIFFERENT SOCIOLOGICAL ECONOMEC STATUS SO JUST A WIDE VARIETY OF INDIVIDUALS, I THINK THE NOTION--PART OF THE NOTION, I THINK I WANT TO GET ACROSS IS THIS ISSUE OF RECRUITMENT IS REALLY A FUNCTION OF SORT OF WHERE YOU LOOK IN PART. SO, RECRUITED IN BARBER SHOPS, OUR STRUCTURE WAS, YOU KNOW ONCE YOU FILLED OUT A QUICK SURVEY, AND THEN YOU WERE INVITED TO COME TO A CLINIC, TO DO THE ACTUAL STUDY, EXPECTATIONS-ANTIREFERS TO YOU FIRST SAW THE PHOTO OF YOUR DOCTOR WHETHER OR NOT HE WAS BLACK OR NOT BLACK AND THE NONPLAQUE PHYSICIANS COULD BE WHITE, THEY COULD BE ASIAN, ASIAN FROM YOU KNOW EAST ASIAN OR YOU KNOW CHINESE DISSENT, ET CETERA OR YOU WERE RANDOMLY SO YOU SAW THAT ON THE TABLET AND EXPOSE IS WHEN YOU ACTUALLY MET THE PHYSICIAN IN PERSON AND YOU WERE ALLOWED ANTI--SO INITIALLY TO MAKE A SELECTION OF ALL SERVICES THEN YOUR CLINICIAN WAS DIRECTED TO ENCOURAGE YOU TO INCREASE ALL OF YOUR SERVICES BECAUSE THEY WERE ALL RECOMMENDED AND WE FOUND THAT JUST KNOWING BY VIDEO OR SEEING THIS PICTURE WHETHER OR NOT YOU HAD A BLACK DOCTOR MAKE NO DIFFERENCE IN TERMS OF PREFERENCE FOR PREVENTATIVE SERVICES BUT THIS INTERACTION, ONCE YOU INTERACTED AND MET YOUR BLACK DOCTOR, THE DRAMATIC INCREASE IN WHAT YOU UPTAKE, IN TERMS OF PREVENTATIVE SERVICES. AND WE THINK THIS ISSUE IS REALLY A FUNCTION OF COMMUNICATION. --WON'T GO THROUGH ALL OF THIS BUT I WILL HIGHLIGHT A FEW THING SWEES DID IN THIS ABOUT 14 SATURDAYS SO THIS NOTION THAT YOU CAN'T RECRUIT DIFFERENT POPULATIONS THAT PART I THINK IS REELGLY, REALLY TRUE, SO YOU COME TO THE CLINIC, YOU RANDOMIZE TO A BLACK OR NONBLACK DOCTOR, THERE'S ACTUALLY HERE, FOR BODY, HEIGHT, WEIGHT, BLOOD PRESSURE, DIABETES SCREENING, CHOLESTEROL WHICH IS TOTAL CHOLESTROL, DIABETES FOR THOSE THAT ARE INTEREST WAS HEMOGLOBIN AC1 Y AND THEN YOU RECEIVE, YOU HAVE THE OPTION TO RECEIVE A FLU SHOT, SO ONCE AGAIN WHEN YOU JUST SAW THE VIDEO OR A TABLET YOU GOT WITH EITHER BLACK OR NONBLACK AND EXPECTATIONS POST, ONCE YOU HAD THE INTERACTION SO YOU HAD THE ABILITY TO REVISE YOUR CHOICES. AND THEN THAT'S REALLY WHAT WE STUDIED AND YOU PROVIDE SOME FEEDBACK, BASICALLY A QUESTIONNAIRE ABOUT YOUR EXPERIENCE. SO INTERESTINGLY WE DID HAVE DECEPTION IN THE STUDY WHERE THE RESEARCH PARTICIPANTS WERE NOT TOLD THAT FLU SHOT WOULD BE PART OF WHAT THEY COULD BE OFFERED. AND WE DID THAT AS PART OF OUR FOCUS GROUPS THAT IT WAS JUST A HUGE AVERSION TO FLU SHOTS SO WE DIDN'T ADVERTISE OR MAKE THEM AWARE AT THE BARBER SHOP LEVEL THAT THEY COULD GET A FLU SHOT BUT THEY WERE MADE AWARE. SO I WILL QUICKLY HIGHLIGHT SOME OF THE DATA SO THIS SHOWS THE ABILITY OF THE NONBLACK DOCTORS ONCE THEY INTERACTED TO INKRES THE AMOUNT OF SERVICES. AND GENERALLY ALL--CHOSE TO GET THEIR BLOOD PRESSURE SCREENED ONCE THEY SAW THE PICTURE, THEN AFTER THE INTERNATION WITH THE NONBLACK PHYSICIAN WAS INCREASED TO ALMOST 3-QUARTERS. SO GENERAL LYE AN IMPROVEMENT ACROSS THE BOARD, FLU SHOT WAS FLAT, NONFLAT DOCTOR THAT INTERESTINGLY WE LOOK AT THE BLACK DOCTORS, YOU SAW WE SEE EVEN MORE ABILITY, INCREASED ABILITY TO INCREASE UPTAKE OR PREVENTATIVE SERVICES, WHEN WE MEASURE AND WE SEE THIS IN FLU IN PARTICULAR, WHEN WE COMPARE THE DIFFERENTIAL ABILITY, RIGHT, SO THIS IS COMPARING THE DIFFERENCE LARGELY BETWEEN THE BLACK VERSUS NONBLACK POSITIONS SO YOU SLEEP APNEA AND OBESITYY THAT FOR INVASIVE SERVICES ANYTHING THAT REQUIRED BLOOD OR A FLU SHOT, THERE WAS WAS JUST A HUGE ABILITY DIFFERENTIAL ABILITY OF THE BLACK PHYSICIANS TO INCREASE THE UPTAKE IN PREVENTATIVE SERVICES, RIGHT? SO WE FELT THERE MIGHT BE SOME DIFFERENCE BUT YOU KNOW WHEN WE LOOKED AT CHOLESTEROL IN PARTICULAR, THIS ALMOST 75% ABILITY TO INCREASE THE SELECTION OF CHOLESTEROL SCREENING WE THOUGHT WAS REALLY DRAMATIC AND SURPRISING SO THE QUESTION IS FOR US AND THEN I WON'T GET INTO SORT OF THIS ISSUE OF YOU KNOW THE MECHANISMS BUT, WE THOUGHT IT WAS REALLY ABOUT COMMUNICATION, RIGHT? AND SO, THIS NOTION OF COMMUNICATION AND RACIAL CONCORDANCE, RIGHT, IT'S REALLY ABOUT THIS TRUSTED MESSENGER AND THIS I THINK AMRIS, THE FINDINGS AND THE THOUGHTS AMRI TO THE RESEARCH SETTING. THIS ABILITY TO DIFFERENTIAL--BETTER COMMUNICATE, SO YOU HAVE A MESSAGE THAT RESONATES AND THEN, WHATEVER THE INCENTIVE IS, RIGHT, THE INCENTIVE COULD BE PARTICIPATE NOTHING RESEARCH FOR MY OWN BENEFIT OR MY FAMILY'S BENEFIT FOR FUTURE GENERATIONS AND THEN I'LL CLOSE HERE WITH, I THINK I'M OUT OF TIME, YOU KNOW, IN THIS PERSPECTIVE OF YOU KNOW PARTICULARLY IN OUR CONVERSATION AROUND JUSTICE. RIGHT, SO FOR THIS STUDY, THE BURDENS AND BENEFITS OF RESEARCH LARGE LYE ARE ACCRUED TO 1 GROUP, RIGHT? BLACK MEN. YOU COULD AWRPG, WELL, FOR YOU KNOW THE GREATER GOOD IF 1 PART OF OUR POPULATION HAS INCREASED HEALTH, THAT'S BETTER FOR THE REST OF US, NOW, BUT THE QUESTION IS WHY AM I NEEDING THIS JUSTICE THRESHOLD BECAUSE I FOCUSED ON 1 GROUP AND YOU KNOW THE BENEFITS ACCRUE TO THE SAME GROUP. MAYBE FOR A RESEARCH SETTING, I'M SURE THAT'S FINE, AS AN INSTITUTION RIGHT, CAN--YOU KNOW CAN I JUST FOCUS ON 1 GROUP OR DO I HAVE AN OBLIGATION TO THINK MORE BROADLY? AND THEN THIS QUESTION S&P THIS A TRICK QUESTION, IF I CAN'T RETAIN OR IF I CAN'T RECRUIT FROM A CERTAIN GROUP TO PARTICIPATE IN CERTAIN RESEARCH BECAUSE THERE ARE ALL THESE ISSUES, YOU KNOW DO I GET A PASS? THAT'S A TRICK QUESTION BECAUSE THE ANSWER IS NO, WE ALL HAVE THIS OBLIGATION TO RECRUIT BROADLY AND OFTEN TIMES, AND I THINK IN THE WORKING DOCUMENT, THIS WAS HIGHLIGHTED, THE BURDENS AND BENEFIT GO HAND IN HAND SO YOU SEE THIS MORE IN--YOU SEE THIS VERY CLEARLY IN BIOMEDICAL RESEARCH WHERE, YOU KNOW THE--YOU KNOW A DRUG WORKS IN A POPULATION BECAUSE THAT POPULATION PARTICIPATES. RIGHT? SO IN ORDER TO GET THAT BENEFIT OF, YOU KNOW THIS DRUG WORKS IN MY POPULATION, I HAVE TO PARTICIPATE AS A--DRUGS IN MY FROWP AND THEN FINALLY I WILL LEAVE YOU WITH THIS NOTION THEY THINK IS REALLY IMPORTANT. THAT BEING UNDERREPRESENTED IN RESEARCH IS NOT THE SAME AS BEING A DISADVANTAGED GROUP, RIGHT? SO AS A BLACK PERSON, RIGHT, SO I'M AN--I AM PART OF AN UNDERREPRESENTED GROUP IN RESEARCH, RIGHT? I'M NOT NECESSARILY DISADVANTAGED ALTHOUGH I HAD MY OWN PERSONAL SHORT COMINGS, YOU KNOW, RIGHT FROM? FROM A SOCIOECONOMIC STANDPOINT I AM NOT DISADVANTAGED. SO WE NEED TO DISENTANGLE THIS BECAUSE THEY'RE WEALTH AND AND WELL-INFORMED CERTAIN RACIAL ETHNIC GROUPS THAT ARE NOT NECESSARILY DISADVANTAGED ABOUT YOU THEY ARE IN FACT UNDER REPRESENTED IN RESEARCH AND I MAY HAVE GONE OVER ABOUT 45-SECONDS STEPHEN BUT THAT WAS THE END OF MY PREPARED REMARKS. >> THANK YOU OWEN AND I SUSPECT THERE WILL BE LOTS OF DISCUSSION WHEN WE HAVE TIME FOR THAT. >> PROFESSOR YEARBY, YOU'RE UP NEXT. >> SO THANK YOU FOR THE OPPORTUNITY TO DISCUSS THE JUSTICE PRINCIPLE, TODAY I WILL PRESENT WORK THAT I PRESENTED AT THE--AND TOOL THAT I CREATED BASED ON ENVIRONMENTAL JUSTICE AND HEALTH IMPAJT TOOLS SO I THINK WILL ASSIST RESEARCHERS AS WELL AS IRBs AND HOPEFULLY THE FDA AND OTHER GOVERNMENTAL AGENCIES ACTUALLY APPLYING JUSTICE. SO I WILL DISCUSS THE BELMONT RULE AND REDEFINE THE JUSTICE AND THEN VELNEARABILITY AND EQUITY ASSESSMENT TOOL. SO WHEN WE THINK ABOUT THE JUSTICE IN THE BELMONT PRINCIPLE THERE ARE TOO PARTICULAR LEVELS, THERE ARE 2 INDIVIDUAL LEVELS INCREASES THAT TALK ABOUT THE RESEARCH UBIQUITINNATION SECTIONAL ANALYSISES AND WHO OUGHT TO RECEIVE THE BENEFITS OF RESEARCH AND BEAR THE BURDENS. AND THEN WE MOVE TO THE SOCIAL LEVEL, TAKEN INTO CONSIDERATION NOT JUST INDIVIDUAL PARTICIPANTS BUT THE POPULATIONS THAT THEY COME FROM, AND REALLY SHOULD THAT POPULATION PARTICIPATE IN RESEARCH THROUGH INDIVIDUALS. FURTHER MORE THE BELMONT REPORT NOTES THAT EVEN AFTER RESEARCHERS BALANCE INDIVIDUAL AND IS SOCIAL LEVEL REQUIREMENTS, BURDENS AND BENEFITS, THAT USING CERTAIN CLASSES OF PEOPLE FOR RESEARCH MAY BE UNJUST BECAUSE OF THE SOCIAL, RACIAL, SEXUAL AND CULTURAL BIASES, INSTITUTIONALIZED IN SOCIETY THAT PLACE A CLASS OF PEOPLE IN A COMPROMISED POSITION. WHEN WE TURN TO THE COMMON RULE WE TALK ABOUT SHOULD THE SUBJECT BE EQUITABLE THAT THE IRB SHOULD TAKE INTO ACCOUNT THE PURPOSES OF RESEARCH AND SHOULD BE COGNIZANT OF THE SPECIAL PROBLEMS OF RESEARCH PARTICULARLY AS IT INVOLVES VULNERABLE POPULATIONS. SO ASSURING THE FAIR AND INCLUSION PARTICIPATION OF VULNERABLE POPULATIONS. I SUGGEST WE NEED TO MOVE FURTHER SO WE'VE GONE FROM JUSTICE SERVING AS PROTECTION FROM THE BELMONT REPORT TO INCLUSION AFTER THE HIV/AIDS DRUG TRIALS, I SUGGEST THAT NOW WE NEED TO REDEFINE JUSTICE IN TERMS OF EQUITY, PARTICULARLY BASED ON THE DOCTORS DEFINITION OF EQUITY IN HEALTH WHICH ACCORDING TO THEM IS THE ABSENCE OF SYSTEMIC DISAR PARITIES AND HEALTH BETWEEN SOCIAL GROUPS WHO HAD DIFFERENT LEVELS OF SOCIAL ADVANTAGED AND DISADVANTAGED BASED ON THEIR POSITION IN OUR SOCIAL HIERARCHY. FURTHER MORE, I WANT TO BRING IN THE HEALTH EQUITY DEFINITION FROM THE GOVERNMENT OF ONTARIO THAT TALKS ABOUT THAT EQUITY IMPOSES A DUTY TO WORK TO REDUCE OR ELIMINATE SOCIALLY STRUCTURED HEALTH INEQUALITIES IN DIFFERENTIAL HEALTH OUTCOMES AND SO WHEN I THINK ABOUT JUSTICE, I THINK ABOUT THAT PARTICULARLY AS WE MOVE FORWARD IN CLINICAL TRIALS OR RESEARCH TRIALS THAT WE THINK ABOUT HOW THE TRIAL CAN REDUCE SYSTEMIC BARRIERS EQUITY BARRIERS TO--HOW DO WE ASSURE THAT IT PROVIDES AND ADDRESSES AND REDUCES OVERALL HEALTH DISPARITIES. SO LET ME RETURN TO DISCUSSING THE TOOL THAT I CREATED SO IT HAS--AND I WILL GO THROUGH EACH 1 IN PARTICULAR. SO WHEN WE THINK ABOUT SCREENING, SCREENING BEGINS TO ANSWER THIS QUESTION ABOUT HOW DO WE SELECT AND USE RESEARCH SUBJECTS PARTICULARLY THOSE WHO COME FROM? THESE QUESTIONS BEGIN TO REQUIRE THE RESEARCHER TO ANSWER WHY ARE THEY CONDUCTING THE RESEARCH AND HOW DOES THIS COMPARE TO THE PRIORITIES OF THE VULNERABLE POPULATIONS THEY PLAN TO USE? NEXT WHEN WE TURN TO SCOPING, THIS REQUIRES THE RESEARCH TO BEGIN TO NOT ONLY IDENTIFY THE BELMONT--SO WHEN WE THINK ABOUT SCREENING OR SCOPING, IT TALKS ABOUT THE RESEARCHERS AND THOSE PATENTING THE MEDICINE TO BEGIN TO QUESTION WHY ARE WE USING THESE PARTICULAR GROUPS. HOW DOES IT CONNECT THE OVERALL GOALS OF THE RESEARCH, HOW DOES IT CONNECT THE OVERALL GOALS OF THE THAT PARTICULAR POPULATION? SO WHAT HAPPENS US AS WE BEGIN TO THINK ABOUT TRANSLATING RESEARCH AND ACTUAL UPTAKE IN THESE PARTICULAR POPULATIONS. NEXT WE MOVE TO IMPACT ASSESSMENT. FIRST THE RESEARCHERS ASSESS WHETHER THE SUBJECTS FROM THE VULNERABLE POPULATION WILL BE A FIRST OR A BENEFICIAL. AND I SUGGEST THEY ENGAGE IN THE POPULATIONS AND THIS IS BASED ON COMMUNE PARTICIPATORY RESEARCH THAT WE SEE IN PUBLIC HEALTH THAT YOU ARE PARTNERING WITH THIS THESE COMMUNITIES NONAPOPTOTIC THE JUST NOT JUST SEEKING OUT PEOPLE TO GET PEOPLE TO ENROLL IN THIS STUDY BUT ACTUALLY AND PARTNER WITH THESE VULNERABLE POPULATIONS TO DETERMINE WHAT ARE THEY SUFFERING FROM WHAT ARE THE NEEDS WE HAVE AND WE SEE THIS IN PRACTICE HERE IN THE U.S. WHERE RESEARCHERS ARE PARTNERING WITH THE NATIVE AMERICAN COMMUNITIES AND OTHER GROUPS PARTICULARLY IN OAKLAND, CALIFORNIA TO WORK WITH POPULATIONS TO DECIDE AND TO CREATE RESEARCH STUDIES. AND HOW THESE CAN BENEFIT THE POPULATION? THE RESEARCH SHOULD GO THROUGH AND DETERMINE THE DISPARITIES, BURDENS, ADVERSE IMPACTS AND BENEFITS AND I WILL GO THROUGH EACH THE RESEARCHER CAN PULL DATA, DO SURVEYS FOCUS GROUPS. ONCE THE RESEARCHER DOES THAT PERSON SHOULD PROVIDE AN EVIDENCE-BASED DETERMINE NATION OF WHETHER THE MEMBERS OF THE VULNERABLE POPULATION SHOULD BE USED AS A RESEARCH SUBJECTS, TALKING ABOUT HOW THE RESEARCH WILL EITHER ELIMINATE DISPARITIES AND/OR BURDENS WHICH WILL OUTWEIGH THE ADVERSE IMPACTS. SO I WANT TO BRIEFLY JUST RUN THROUGH SOME OF THE KEY COMPONENTS OF THE IMPACT ASSESSMENT. ONE IS TO DEWHAT ARE THE DISPARITIES FOR THE POPULATION OF THAT THE RESEARCH SUBJECTS ARE COMING FROM. ARE THERE SURVIVAL DISPARITIES, ARE THERE DISBARRITIES IN ACCESS TO HEALTHCARE. WHAT IS THE EVIDENCE BOTH QUANTITATIVE AND QUALITATIVE AROUND DISPARITIES. WHAT ARE SOME OF THE BURDENS THAT INDIVIDUALS, THESE VULNERABLE POPULATIONS SUFFER, WHAT ARE THE ROUTE CAUSES, AS WAS MENTIONED BEFORE, WE KNOW THAT STRUCTURAL WE KNOW THAT STRUCTURAL INEQUALITIES, RACISM, SEXUAL, OR OTHERS EXIST, HOW ARE THESE IMPACTING THE VULNERABLE POPULATIONS AND WILL THE RESEARCH FURTHER EXACERBATE THESE PROBLEMS. WE TURN NOW TO ADVERSE IMPACTS LOOKING PARTICULARLY AT THE RESEARCH TO SEE WILL IT HAVE A POTENTIAL FOR ADVERSE IMPACTS. IT ALSO REQUIRES A RESEARCH TO THINK ABOUT PERHAPS SOME UNINTENDED CONSEQUENCES. WHEN WE DO RESEARCH ON PARTICULAR GROUPS, OFTEN TIMES WE DON'T TAKE INTO CONSIDERATION WILL IT HAVE AN UNINTENDED CONSEQUENCE OF STIGMATIZING A PARTICULAR GROUP AND THEN MUST BE TAKEN INTO CONSIDERATION. FINALLY, WE NEED TO,A SESES WHETHER THE SOLUTION WILL ADDRESS THE SPACE BY THE VULNERABLE POPULATION? WILL IT ADDRESS THE ROOT CAUSES, SOME THE BURDENS? TO ACTUALLY QUANTIFY AND BEGIN TO CRYSTALLIZE WHAT ARE THE BENEFITS FROM THE RESEARCH. AS I MENTIONED AFTER GOING THROUGH ALL OF THOSE QUESTIONS ABOUT THE BURDENS, DISPARS--THIS IS HA WILL HAPPEN AS PART OF THE RESEARCH RIGHT THAT THESE VULNERABLE POPULATIONS WILL NOT BE OVERBURDENED AND THEY WILL RECEIVE A BENEFIT FROM PARTICIPATION IN THE RESEARCHER. IN THE RESEARCH. IF THE RESEARCHER DECIDES TO USE THIS AS IMPACT, THE RESEARCH MUST DEVELOP AND IMPLEMENT AN EVIDENT BASED STRATEGY TO MINIMIZE TO MINIMIZE ADVERSE IMPACTS, PAYMENT OF MONEY AND ACCESS TO FREE HEALTHCARE TO JOIN THE TRIAL IS NOT ENOUGH TO MITIGATE THE ADVERSE IMPACTS BECAUSE WE KNOW MEMBERS OF VULNERABLE GROUPS OFTEN LACK ACCESS TO HEALTHCARE, AND RESOURCES BEYOND THE RESEARCH AND SO JUST PROVIDING THOSE SOURCES DURING IS NOT GOING TO ADDRESS ANY LONG-TERM IMPACTS. AND FINALLY AFTER THE RESEARCH IS DONE, THE RESEARCHER MUST MONITOR MITIGATION STRATEGY AND THE IMPACTS DURING THE STUDY AND AFTER THE STUDY IS DONE THEN PROVIDE EVIDENCE OF HOW THE RESEARCH DID NOT OVERBURDEN THE PARTICULAR POPULATION. AND THAT GOES INTO EVALUATION SO HOW COULD THIS BE USED. THE TOOL COULD BE USED BY RESEARCHERS TO UNDERSTAND HOW THEIR RESEARCH CAN INCREASE BARRIERS TO HEALTH EQUITY AND IT ALSO REQUIRES THEM TO PARTNER WITH THE COMMUNITY WHICH BUILDS TRUST AND INSURES THAT AS THE RESEARCH IS DONE THAT MEMBERS OF THOSE POPULATIONS WILL USE WHATEVER COMES OUT OF THE RESEARCH. IT PROVIDES GUIDANCE TO IRBs, PARTICULARLY QUESTIONS AND THINGS TO LOOK FOR IN TERMS OF TRYING TO IEE, AUDIENCE DENTIFY WHETHER THE RESEARCH COMPLIES WITH THE JUSTICE PRINCIPLE. IT PROVIDES FUNDERS, AS WELL AS THOSE WHO ARE PROVING PATENTS AND DRUG APPROVALS WITH A MEASURABLE TOOL AND WHICH TO IDENTIFY WHETHER THE JUSTICE PRINCIPLE IN TERMS OF BENEFITS AND BURDENS IS ACTUALLY BEING MET. AND SO WITH THAT I WILL STOP HERE, HERE ARE THE ARTICLES WE'VE WRITTEN REALLY APPLY IN THE TOOL TO VARIOUS INCIDENTS OF EXPLOITATION AND TARGETING TACKERET BEING OF CHILDREN AND ETHNIC MINORITIES AND TRIALS AND HOW THIS TOOL COULD HAVE PREVENTED THAT. SO WITH THAT THANK YOU AND I LOOK FORWARD TO YOUR QUESTIONS? NOW WE WILL TURN TO BARBARA BIERER SO MUCH FOR INVITING ME IT'S WONDERFUL TO BE BACK AGAIN. I DON'T THINK YOU WILL HEAR MUCH ARGUMENT ON THIS PANEL, I REALLY WANT TO THANK MY COLLEAGUES OWEN AND UPON DR. YEARBY, FOR THEIR PRESENTATIONS, GAVE US A GREAT FRAMEWORK TO THINK THROUGH AND ON A WONDERFUL DATA DRIVEN EXAMPLE OF THE IMPORTANCE OF WORKFORCE DEVELOPMENT AND OF UNDERSTANDING WHAT WE SHOULD AND SHOULD NOT BE DOING WITH THESE STORIES. SO WHAT I WILL PRESENT KNOW ON TODAY IS WORK DONE OVER THE LAST 3 YEARS ON DIVERSITY INCLUSION AND EQUITY AND I WANT TO SAY THAT ALL OF THE WORK I PRESENT S&P OUR OWN AND DOES NOT IMPLY ENDORSEMENT OR REFLECT THE VIEWS OF THE FDA OR ANY OF OUR ORGANIZATIONS ALTHOUGH OF COURSE PERSONALLY I THINK THEY SHOULD. AND WE'RE SUPPORTED BY VOLUNTARY [INDISCERNIBLE]. --THE GUIDANCE AND TOOL KIT AND THEN GIVE A SUMMARY OF THAT BUT THEN FOCUS ON THE ROLE OF THE IRB AND IF WE HAVE TIME, THE HRPP, THE HUMAN RESEARCH PROTECTION PROGRAM IN ACHIEVING DIVERSITY INCLUSION AND EQUITY BECAUSE I THINK THAT IS 1 OF THE CENTRAL COMPONENTS OF QUESTIONS BASED BY SACHRP HERE, IT'S NOT WHAT CAN WE DO AS A SOCIETY ALTHOUGH THE GUIDANCE AND TOOL KIT DOES GO THROUGH MANY DIFFERENT ROLES AND RESPONSIBILITIES BUT TODAY I WILL FOCUS ON THIS 1. SO THE EMRCT CENTER AS STEVE SAID IS A RESEARCH IS POLICY CENTER FOCUSED ON THE CONDUCT, ETHICS AND REGULATORY ENVIRONMENT OF INTERNATIONAL MULTISITE CLINICAL TRIALS WITH DEDICATED TO IMPROVING SAFETY, RIGOR AND INTEGRITY OF THOSE TRIALS AND WE DO THAT WORK BY ENGAGING DIVERSE STAKEHOLDERS FROM ACADEMIA, INDUSTRY, PATIENT-PATIENT ADVOCATES, REGULATORS, AND DEPENDING ON THE PROJECT JOURNAL EDITORS, AND OTHERS, WHOEVER IS INVOLVED IN THE EMERGING ISSUE TO DEFINE THE PROBLEM AND THEN TO REALLY THINK THROUGH PRACTICAL SOLUTION THINKING THAT IF IT WORKS FOR EVERYBODY IN THE PROBLEM, IT'S MORE LIKELY TO BE A SOLUTION THAT IS ADAPTABLE AND PRACTICAL AND THE IMPLEMENTABLE, AND INDEED WE ALREADY HAVE THEN FROM WORKING WITH THE NUMBER OF PEOPLE, HAVE SORT OF LEADERS WHO APPRECIATE THE CALL TO ACTION. AND WHY DID WE WORK ON THIS? WELL, YOU KNOW I HAVE TO SAY WE'VE BEEN WORKING ON THE LAST 3 YEARS AS I MENTIONED ON DIVERSITY AND INCLUSION BUT THERE'S NO OTHER TIME WHERE IT'S BEEN EVER MORE PRESENT AND TOP OF MIND THAN DURING THE COVID-19 PANDEMIC WHEN YOU LOOK AT, YOU KNOW THIS IS ADJUSTED FOR AGE, RACE ETHNICITY WIDENS THE GAP IN MORTALITY AS IT DOES IN INFECTION, FOR PLAQUE, LATIN X AND INDIGENOUS AND PACIFIC ISLANDER AND ASIAN POPULATIONS, SIGNIFICANTLY 3 AND HALF FOLD. AND 1 OF THE TERRIBLE THINGS ABOUT THIS IS WE REALLY DON'T KNOW WHY, WE DON'T KNOW WHETHER IT'S CO-MORBIDITIES AND UNDERLYING GENETICS. IS IT BECAUSE THEY LIVE IN MULTIGENERATIONAL FAMILIARLYS BECAUSE THEY COMMUTE TO WORK ON A BUS BECAUSE THEY'RE DEFINED AS ESSENTIAL WORKERS BECAUSE THEY ARE CENTRAL WORKERS WE DON'T--WE DON'T EVEN COLLECT THAT DATA SO 1 OF THE PROBLEMS HERE IS THAT WE SET UP A SYSTEM FOR RACE AND ETHNICITY TO SERVICE AS A SURROGATE FOR WHAT IS IN MANY WAYS SOCIAL DETERMINANTS OF HEALTH AND OTHER FACTORS WHICH WE HAVE NOT YET UNDERSTOOD. SO WE NEED TO THINK THROUGH WHY WE'RE FOCUSED ON THIS AND HOW TO UNPACK THE AND THEN FOR THE INFORMATION WE DERIVED, EVEN WITH THIS DATA HAVING SEEN IT, IT IS CHILLING THAT OUR CLINICAL TRIALS FOR COVID TREATMENT AND VACCINES STILL UNDERREPRESENT THE RACIAL AND ETHNIC MAJORITY POPULATIONS THAT ARE HARDEST HIT BY THE PANDEMIC AND THIS HAS BEEN WELL REPORTED AND IS TRUE IN LOTS OF PLACES. UNFORTUNATELY THIS IS NOT NEW AND WE HAD AS I MENTIONED STARTED THIS WORK A WHILE AGO, WE RELEASED THE DOCUMENT WHICH IS A BIT OF A BEAR TO UNPACK, IT'S A TOTAL OF WHATEVER BETWEEN THE 2 DOCUMENTS, THE IMIEDANCE AND THE TOOL KIT ABOUT 500 PAGES. SO, IT'S A LOT BUT WE WANTED TO TAKE A COMPREHENSIVE LOOK ACROSS ALL THE STAKEHOLDERS INVOLVED ACROSS ALL THE DIMENSIONS OF DRUG DEVELOPMENT AND CLINICAL TRIALS WHERE WE UNDERSTOOD BARRIERS TO INCLUSION, WE ADDRESSED WHAT COULD PRACTICALLY BE DONE AND I CAN SPEAK ABOUT WAWE'RE DOING IN THE FUTURE IN THIS REGARD. SO THIS WASY LED BY [INDISCERNIBLE] AT THE U.S. FDA AND HER COLLEAGUE AT HER CLEG AT MERK, AND DAVID STRAUSS AND SARAH WHITE AND MYSELF, AND ASSISTED BY STAFF AND MAJOR CONTRIBUTORS TO THE WORK. BUT WHILE WE LET IT, THIS WORK REALLY REFLECTS THE INVALUABLE CONTRIBUTIONS INDIVIDUALLY THEY REPRESENT HUGE DISCIPLINARY HAVEERCITY IN AGE, SEX, CO-MORBIDITIES, PATIENT STATUS, RACE/ETHNICITY AND AND YOU KNOW WHERE THEY COME FROM IN WHAT ORGANIZATION THEY PRESENT. WHEN WE STARTED THIS WORK, THERE WAS A LOT--I THINK WE FELT WE HAD TO JUSTIFY WHY THIS WAS IMPORTANT IN CLINICAL TRIALS MUCH MORE THAN WE DO TODAY. SO AS I SAID WHERE THIS WAS A MULTISTAKEHOLDER CONTRIBUTION AND NOT A CONSENSUS, A TRUE METHOD BUT WHAT CONSENSUS OF WHAT EVERYBODY COULD LIVE WITH, I THINK WE GIVE VERY PRACTICAL RECOMMENDATIONS. IN THE ACCOUNTABILITY SECTION AND THREAD IT THROUGHOUT THE DOCUMENT IS THE ROLE OF EACH OF THESE STAKEHOLDERS AND WHAT THEY CAN DO, AND THEN IN THE TOOL KIT, WE PROVIDE SOME RESOURCES THAT WE COULDN'T FIND EASILY ELSEWHERE AND WE'RE CONTINUING TO BUILD THOSE RESOURCES. TODAY AS I SAID, I AM GOING TO TALK ABOUT THE IRBs AND ETHICS COMMITTEE, I WILL FOCUS THIS ON ISSUES ATTENDED TO THE U.S., BUT OF COURSE THERE'S HUGE PROBLEMS INTERNATIONALLY THAT WE CAN TALK TO. I ALSO WANT TO SAY THAT YOU KNOW THE IRBs DON'T EXIST WITH THE EXCEPTION OF THE INDEPENDENT IRBs IN A VACUUM, THEY LIVE WITHIN RESEARCH INSTITUTIONS AND SITES, AND AGAIN WE CAN COME BACK TO THAT AS WELL. SEBEYOND COVID-19 IS THERE A PROBLEM TO SOLVE? IS THE WORLD FOR THE IRB JUSTIFIED? IS THAT WHERE SOME CERTAINLY NOT THE ONLY PLACE AND IS IT THE RIGHT PLACE AND WHAT PRACTICAL STEPS CAN BE TAKEN. SO, WE STARTED THIS WHEN WE SAW THE 2016 WHICH WAS PUBLISHED LATE THAT YEAR, OR 2017 ACTUALLY, DRUG TRIAL SNAPSHOTS WHICH IS AN FDA DOCUMENT THAT PUTS OUT THE PROPORTION OF RACE, ETHNICITY AND GENDER FOR EACH DRUG APPROVED IN THE PREVIOUS YEAR, SO OF COURSE, THERE'S--YOU KNOW THE RANDOMNESS IN TERMS OF WHAT THE POPULATION WAS AND IT'S ONLY THE PIVOTAL TRIALS IN THAT YEAR AND WHAT WE SAW IS CARDIOVASCULAR DISEASE AND ONCOLOGY, LESS THAN 3% OF THE PATIENTS WERE BLACK OR AFFRIC ARN AMERICAN AND DESPITE THE FACT THAT WE KNOW THAT MANY IN THE ONCOLOGY DISEASES, THE INCIDENTS AND SEVERITY FOR CANCER AND CARDIOVASCULAR DISEASE IS MORE SEVERE IN BLACK AND AFRICAN AMERICANS AND IT IS POSSIBLE TO RECRUIT MORE BLACK AND AFRICAN AMERICANS IN PSYCHIATRY WHICH IS GENERALLY SERIOUS MENTAL ILLNESS, ALMOST 25% OF THE POPULATION WERE PLAQUE AND AFRICAN AMERICAN. WE DON'T KNOW WHY THAT IS, WHETHER THEY WERE RECRUITING FROM THE MEDICARE POPULATION OR HOSPITALS OR IN GEOGRAPHIES BUT WE HAVE NO INSIGHT INTO THAT AND YET, WE SAW THAT THIS GREAT DISPROPORTIONATELY WAS SOMETHING THAT IS CORRECTABLE OR DRESSABLE AND NEEDED TO GET BE ADDRESSED WE HAD A BIOETHICS LABRATIVE AND THAT EVOLVED TO THE WORK GROUP. SO THIS IS BASICALLY THE SORT OF ARGUMENT IN A NUT SHELL, AS YOU ALL KNOW TO DEVELOP NEW DIAGNOSTICS, TREATMENTS AND VACCINES WE NEED CLINICAL TRIALS, AND THE PARTICIPANTS IN THE TRIALS AS WAS SAID SHOULD REFLECT THE POPULATION AFFECTED BY THE DISEASE OR THOSE USING OR INTENDED TO USE THE INTERVENTION. IMPORTANTLY, WE SHOULDN'T ASSUME THAT ALL INDIVIDUALS WILL RESPOND SIMILARLY TO INTERVENTIONS AND IF YOU START FROM THE HYPOTHESIS THAT ALL POPULATIONS WILL BE HOMOGENOUS TO PROVE A DIFFERENCE, AND PROVIDING AFFIRMATIVE EVIDENCE THAT SAFETY AND EFFICACY IS EQUIVALENT IN THE VARIOUS SUBPOPULATIONS. WE ALSO KNOW THAT UNDERREPRESENTATION AT ALL ENDS OF THE SPECTRUM, ELDERLY AND PEDIATRICS AND CERTAINLY UNDERSERVED POPULATIONS IS NOT NEW, IT'S TRUE IN BOTH INDUSTRY AND ACADEMIC TRIALS, IT'S ACROSS THERAPEUTIC AREAS AND AND IT'S ALSO TRUE THAT THE BIOLOGY IS INTRICATELY INTERTWINED WITH SOCIAL DETERMINANTS OF HEALTH. STRESS ITSELF HAS AN IMPACT ON INFLAMMATION AND OTHER DISEASE WE DON'T UNDERSTAND THE PATHOPHYSIOLOGY BUT WE KNOW THAT THIS IS--THIS IS TRUE AND REPRESENTATION IN CLINICAL TRIALS IS NOT SIMPLY A MATTER OF UNDERSTANDING BIOLOGICAL HETEROGENEITY, IT'S ALSO A MATTER OF HEALTH EQUITY, FAIRNESS AND PUBLIC TRUST, ABOUT YOU YOU DON'T HAVE TO REACH TO PROMOTING SOCIAL JUSTICE TO ARGUE THAT THIS IS IMPORTANT IN RESEARCH BECAUSE IT'S ABSOLUTELY FUNDAMENTAL IN BEING ABLE TO GENERALIZE THE RESEARCH FUNDING WE HAVE AND TO GENERATING RELIABLE DATA SO WE CAN COME BACK TO THIS POINT. SO, IF YOU LOOK AT THE APPLICATION OF THE BELL MONTGOMERY ALEX PRINCIPLES, THE PIECE YOU'VE WRITTEN DOES A WONDERFUL JOB OF THAT AND IT'S BEEN REVIEWED BY MY COLLEAGUES. I SHOULD SAY THAT, YOU KNOW THE BELMONT DOCUMENT GREW OUT OF--OUT OF A SERIES OF UNFORTUNATE RESEARCH HISTORY THAT REALLY FOCUSED ON PROTECTING THOSE THAT WERE MOST VULNERABLE AND AS DR. YEARBY MENTIONED, THAT IS WE REALLY MOVE FORWARDS A POSITION NOT OF PROTECTION OR CONSIDERING PROTECTION BUT ALSO CONSIDERING THE BENEFITS OF INCLUSION. AND CERTAINLY SOME CLINICAL TRIALS HAVE DIRECT BENEFITS OF THE NOVEL OR INVESTIGATIONAL THERAPY, WE ALSO AND THEREFORE SHOULD BE CONSIDERED A BENEFIT IF YOU DENY ACCESS TO IT, YOU ARE DENY HADDING ACCESS TO THAT BENEFIT AND IT'S, YOU KNOW THERE IS DATA TO SUGGEST THAT ANYONE IN A CLINICAL TRIAL DOES BETTER THAN PEOPLE NOT IN A CLINICAL TRIAL WHICH IS ANOTHER INTERESTING ARGUMENTIVE THING ABOUT HOW THAT PLAYS HERE. SO THE ETHICS INCLUSION AND ACCESS TO THE BENEFITS NOT ONLY OF THE DIRECT BENEFITS BUT ALSO TO THE LATER BENEFITS FROM SCIENTIFIC KNOWLEDGE OF UNDERSTANDING WHAT THE IMPACT IS ON WHAT POPULATION IS AN IMPORTANT POSITION TO TAKE. AND OF COURSE, THE OBJECTIVE OF ALL RESEARCH IS TO CONTRIBUTE TO GENERALIZABLE KNOWLEDGE THAT ITSELF IS FOUNDATIONAL TO THE DEFINITION AND JUSTIFICATION. SO THE IMPORTANCE OF INCLUSION, ANALYSIS OF GROUP DIFFERENCES AND SAFETY EFFICACY AMONG DIVERSE POPULATIONS CAN PROMOTE IDENTIFICATION BOTH OF THE UPDATER LYING BIOLOGICAL FACTORS AND SOCIALLY RELEVANT FACTORS THAT AFFECT HEALTH, THE SOCIAL DETERMINANTS OF HEALTH AS QUOTED IN THE BELMONT REPORT AND IT'S--1 CAN IDENTIFY BOTH AND IT SPEAKS TO THE FAIRNESS AND THE DISTRIBUTION OF BENEFIT AND IT IS BURDENS WITH THE CAVEATS WE JUST HEARD ABOUT MAKING SURE THAT WE ONLY BURDEN THAT WHICH IS NECESSARY FOR THE IMPORTANCE OF THE BENEFIT AND THE BURDEN IS MINIMIZED. AND IT BUILDS PUBLIC TRUST. SO, QUOTING FROM THE BELMONT REPORT, JUSTICE IS RELEVANT TO THE SELECTION OF SUBJECTS OF RESEARCH AT 2 LEVELS. SOCIAL AND INDIVIDUAL. MY PREVIOUS SPEAKER DISSECTED THAT. INJUSTICE MAY APPEAR IN THE SELECTION OF SUBJECTS EVEN IF INDIVIDUALS SUBJECTS ARE SELECED FAIRLY BY INVESTIGATORS TREATED FAIRLY IN THE COURSE OF RESEARCH, THUS INJUSTICE ARISES FROM SOCIAL RACIAL SEXUAL AND CULTURAL BIASES, INSTITUTIONALIZED IN SOCIETY. IMPORTANTLY IF WE CONTINUE TO DO THAT WE CONCRAITIZE THE SYSTEMIC RAISISM AND CONCLUSIONS AS WELL. AND INJUSTICE OCCURS WHEN SOME BENEFIT TO WHEN A PERSON IS JUSTICE IS DE9ED WITHOUT REASON AND WE SEE THE NOGZ NOTION OF DISTRIBUTED JUSTICE SO WHO OUGHT TO RECEIVE THE BENEFITS OF RESEARCH AND BEAR ITS BURDENNINGS, FAIR PROCEDURES AND OUTCOME AND YOU WILL SEE THE 46.111 CRITERIA THAT SELECTION OF SUBJECTS AND EQUITABLE DIRECTLY FROM THERE. BENEFICENCE, SPEAKS TO--I REALIZE I'M SPEAKING EVER QUICKER BECAUSE--SOCIETY OR OBLIGATED TO RECOGNIZE THE LONGER TERM BENEFITS AND RISKS THAT MAY RESULT AND FINALLY RESPECT FOR PERSONS WHICH YOU KNOW. SO HOW DO YOU DO THAT? HOW DO YOU FOCUS ON THE ROLE OF THE DIVERSITY OF THE IRB AND ADVANCING DIVERSITY? I'LL TAKE YOU THROUGH THIS QUICKLY AND WE CAN ALSO COME BACK TO IT. WE WENT THROUGH AND DAVID STRAUSS SARAH AND I HAVE A PAPER UNDER REVIEW TO ADVANCE SOME OF THESE THINKING THAT INITIAL REVIEW 1 SHOULD LOOK AT THE STUDY AIMS AND STUDY SELECTION THAT SHOULD REFLECT THE EPIDEMIOLOGY OF THE DISEASE OR WHO WILL USE THE THERAPEUTIC OR DEMOGRAPHIC OR THERAPEUTIC OR DIAGNOSTIC. DOES THE DEMONY GRAPHIC OF THE PROPOSED SAMPLE REFLECT THAT OF THE POPULATION, IF IT DOES NOT IS THE DEVIATION ADEQUATELY JUSTIFIED, IS PLANNED UNDER OR OVER REPRESENTATION BY ANY OF THOSE DIMENSIONS SCIENTIFICALLY JUSTIFIED AND IS THERE A STATISTICAL PLAN FOR ANALYSIS. YOU CAN SEE HOW 1 COULD I SECTIONAL ANALYSIS INTO EACH OF THESE FURTHER KRIST TERRIA FOR INCLUSION DOES IT UNNECESSARILY RESULT IN UNDER OR OVER REPRESENTATION OF UNDERSTUDIED SUBGROUPS, HAVE ALTERNATIVE APPROACHES TO MINIMIZING RISK, BEEN CONSIDERED AND WE GO THRAW IN THE DOCUMENT MANY OF THESE CRITERION AND HOW TO THINK ABOUT THEM AND IN RECRUITMENT ARE THERE SPECIFIC APPROACHES TO ENGAGE UNDERSERVED POPULATIONS IN STUDY CONDUCT ARE THE STUDIES ORGANIZED TO MEET THE NEEDS OF ALL GROUPS TO ALL PARTICIPANT FACING MATERIALS CONFORM TO HELP LITERACY PRINCIPLES, ARE THEY TRANSLATED IF NOT, WHY NOT. IS PAYMENT SUFFICIENT TO COVER ALL PARAMETERS AND ARE THE RESULTS SUFFICIENT TO MEET THE NEEDS OF THE POPULATION AND THAT FOCUS CAN CONTINUE TO REVIEW, HAS THE STUDY ITSELF FULFILLED OR IS FULFILLING ITS RECRUITMENT AND ACCRUAL GOALS. IS THE DEMOGRAPHIC DISTRIBUTION ON TRACK, IF NOT, ARE THERE ADEQUATE DIRECTIVE ACTIONS DESCRIBED SUFFICIENT AND LIKELY TO BE SUCCESSFUL? SO, WE THINK THE ROLE OF THE IRB IS TO INSURE ETHICAL RESEARCH TO CREATE EXPECTATIONS, PROMOTE THE DIALOGUE, IT DOES NOT SAY THAT IT HAS TO BE TRUE IN EVERY SETTING, BUT 1 HAS TO ASK FOR THE EVIDENCE AND MAKE SURE THAT THESE THINGS ARE WELL THOUGHT OUT. IT ESTABLISHES ACCOUNTABILITY AND FOSTERS CONFIDENCE AND EDUCATION AND THE DEVELOPMENT OF INFRASTRUCTURE. I KNOW I DON'T HAVE TIME TO TALK ABOUT THE ROLE OF THE HRPP ALTHOUGH I WOULD LOVE TO COME BACK TO IT AND WE REALLY BELIEVE THAT IF YOU ASK THE QUESTION, OF INVESTIGATORS IF YOU ASK THE QUESTION OF SPONSORS, YOU WILL CHANGE BEHAVIOR, YOU WILL CHANGE BEHAVIOR QUICKLY. SO OBVIOUSLY THERE ARE IMPORTANCE OF METRICS OF TRANSPARENCY OF THOSE METRICS AND ACCOUNTABILITY, AND PROGRESS TAKES TIME BUT WHAT WE DO EVERY DAY EACH DAY WILL BE IMPORTANT FOR TRANSFORMING THIS. WE ARE IN THE MIDDLE OF DOING A SERIES OF PRESENT ANTICIPATIONS ON DIFFERENT ASPECTS AND PRESENTING AS WELL IN NOVEMBER ON THIS ASPECT AS WELL. SO WITH THAT LET ME STOP TALKING AS FAST AS I CAN AND TURN IT BACK TO STEVE. >> THANK YOU VERY MUCH. SO I WILL MAKE AN OBSERVATION AND WE WILL OPEN THE FLOOR TO QUESTIONS AND DISCUSSIONS FROM THE COMMITTEE. YOU KNOW WATCHING ALL OF YOUR WONDERFUL PRESENTATIONS, I AM STRUCK BY A COMMITMENT TO FIXING A PROBLEM BUT IT'S A COMMITMENT THAT WILL REQUIRE CHANGE AND RESOURCES. AND YOU KNOW I KNOW MOST OF YOU WERE NOT PARTICULARLY--THE PANELISTS WERE NOT HERE FOR THE EARLIER PART OF THE MEETING WHERE WE TALKED ABOUT WHAT THE ROLE OF THE IRB SHOULD BE IN PROTECTING THE RIGHTS AND WELFARE OF PEOPLE WHO ARE NOT DIRECTLY ENROLL INDEED RESEARCH CENTERS BUT WHO MAY BE ECPOSED TO RISK AS PART OF THE RESEARCH. AND 1 OF THE PUSH BACKS WE RECEIVED ABOUT THAT PARTICULARLY WHEN IT'S BEEN DISCUSSED AT THE SUBCOMMITTEE AND THE SUBCOMMITTEES ARE MADE UP REALLY MORE THAN THE COMMITTEE OF PEOPLE WHO ARE PRACTICING IRB PROFESSIONALS. WAS, WELL, YOU KNOW WE'RE REALLY WORRIED ABOUT BEING ASSIGNED WHAT THEY CALL MISSION--BEING ASSIGNED THINGS WITHOUT OUR RESEARCH BEING INCREASED OR WITHOUT BUDGETS JUST ANOTHER THING FOR THE IRB TO REVIEW. AND IT STRIKES ME THAT THE--AND I JUST RAISED THIS, I DON'T KNOW THE ANSWER. AND I DIDN'T PUT IT IN THE DOCUMENT THAT WE HAVE LATER BUT WE--KEP THEM ON, YOU KNOW AT A LEVEL OF EFFORT AND DETAIL THAT THEY JUST DON'T DO THAT. NOT ONLY THE IRB, INSTITUTIONS AND INVESTIGATORS, AND THE QUESTION IS WHAT WE WILL HEAR IS I HAVE NO MONEY FOR THAT, THE MONEY WILL COME OUT OF MY RESEARCH INSTITUTION OR ORGANIZATION OR WHEAR --WHATEVER AND I AM NOT DEFENDING THAT BUT WE ALWAYS HEAR THAT AND I JUST WONDER, THAT LEADS MOOY TO THINK THAT WE SHOULD BE EXPLICIT ABOUT CALLING FOR NOT JUST RESEARCH INTO THIS AREA AS WE ALREADY DO, BUT ACTUALLY THE ALLOCATION OF RESOURCES TO DEAL WITH THIS EXPLICITLY. ANYWAY IT'S JUST 1 OBSERVATION THAT STRUCK ME AS I WAS LISTENING TO ALL THESE SUGGESTIONS AS WE APPROACH THIS PROBLEM. SO I'M NOW WATCHING FOR HANDS. AND I KNOW THERE ARE PEOPLE. JANET. THERE WE GO. >> THANKS STEPHEN, I CAN'T ADDRESS ALL OF THIS BECAUSE IT'S SUCH A HUGE PROBLEM BUT 1 THING THAT POPPED IN MY HEAD BECAUSEIME INVOLVED IN THE RARE CANCERS COMMUNITY AND VERY OFTEN THERE ARE CLINICAL TRIALS THAT HAVE A HARD TIME RECRUITING ENOUGH PEOPLE BECAUSE THEY CAN'T HAVE MULTIPLE SITES WHEN THEY CAN'T SORPT IT WHEN THERE'S NOT ENOUGH PATIENTS AND THEY OFTEN GET THE DRUGS APPROVED UNDER THE ALLOWANCE THAT LETS THE FDA GRANT APPROVAL UNDER A PHASE 2 TRIAL WITHOUT GOING TO A PHASE 3. AND I'M WONDERING WHAT'S THE ROLE OF THE IRB IN TRYING TO REQUIRE THAT THE SPONSOR GATHER REAL WORLD DATA TO MAKE SURE THEY'VE INCLUDED THE DIVERSITY THAT'S REPRESENTED IN THE DISEASE WHEN IT'S VERY DIFFICULT TO GET ENOUGH PATIENTS ENROLLED IN THE TRIAL IN THE FIRST PLACE? >> I WILL SPEAK TO THAT. AS WELL AS TO INITIAL BUOYANT ABOUT ALLOCATION FOR MORE RESOURCES. ONE, IF WE HAVE COMMITTED OURSELVES AS A NATION, AND AS A GOVERNMENT TO ADDRESS HEALTH DISPARITIES PARTICULARLY UNDER SOCIAL DETERMINANTS OF HEALTH MODEL, YEAH, WE HAVEN'T ALLOCATED PROPERTILY TO PAY PEOPLE TO DO THIS. AND SO IT IS IMPORTANT THAT AS WE MOVE FORWARD TO TALK ABOUT ADDRESSING HEALTH DISPARITIES THAT IT CAN BE SIMPLY PUTTING MORE MONEY INTO RESEARCH THAT IT HAS TO BE PUTTING MONEY INTO THE COMMUNITY THAT ARE IMPACT, I CAN WILL IT YOU THAT I HAVE DONE A FEW GRANTS WHICH IS RARE RARE FOR A LOW PROFESSOR BUT FOR EACH OF THE GRANTS WE HAVE DONE, WE HAVE BUDGETED MONEY OR SPECIFICALLY OR EITHER PARTNERED WITH THE COMMUNITY TO INSURE THEY HAVE EQUAL MONEY TO PARTICIPATE IN IT. SO I THINK THAT IF WE ARE ASKING IRBs AND RESEARCHERS TO DO THAT, THEN THEY NEED TO PUT A LINE ITEM IN THE RESEARCH BUDGET, THAT THE NIH, THE FDA, THE CDC, AND OTHER FUNDERS NEED TO ACTUALLY PAY FOR TO ALLOW THEM TO HAVE THESE GROUPS TO PARTICIPATE BECAUSE OTHERWISE, YOU DO RESEARCH AND THEN IT DOESN'T GET INTO THE GROUPS THAT YOU ARE TRYING TO GET IT TOO. ONE BECAUSE THEY'RE NOT PARTNERING, THEY THINK YOU'RE EXPLOATING THEM AND YOU ARE NOT BUILDING TRUST BUT 2, ALSO IT MEANS THAT IT DOESN'T GET--IT DOESN'T RECOGNIZE THE LIVED EXPERIENCES. SO I WOULD JUST SAY THAT GOES TO SORT OF THIS ALLOCATION AND IT'S NOT--FOR MY TOOL, I THINK THAT THERE ARE LOTS OF PEOPLE WHO ARE DOING THESE--THIS RESEARCH AND COMMUNITY THAT ARE ALREADY PARTNERING WITH THESE GROUPS AND SO, I DON'T LEAVE IT UP TO THE RESEARCHER OR THE RIERKS RB TO ACTUALLY DO THIS WORK--OR THE IRB TO DO THIS WORK, BUT TO PULL THESE PEOPLE IN. IT'S THE SAME WHEN WE GO TO DROSOPHILA INTERNATIONAL TRIALS AND I'VE BEEN A PART OF INTERNATIONAL TRIALS, YOU ALWAYS PARTNER WITH THE COMMUNITY, YOU ALWAYS WORK WITH SOMEBODY THERE. IN TERMS OF PULLING INFORMATION ABOUT AND IN THE AREA WHERE IT'S AVAILABLE BUT MOST OF THE DISEASES WE HAVE IN THE U.S., WE DO HAVE RESEARCH OUT THERE THAT TALKS ABOUT THE GROUPS THAT ARE MOST IMPACTED, RACIAL, ETHNIC, GENDER DISPARITIES AND THAT'S WHAT I'M ASKING PEOPLE TO DO IS TO PULL THAT THAT RESEARCH TO I THINK--THAT DATA, THERE'S A REASON WE'RE PULLING THAT DATA TO HIGHLIGHT DISPARITIES AND I THINK IT'S A GOOD IDEA TO USE THAT DATA IN THE RESEARCH THAT WE ARE DOING BUT ALSO IN WAYS TO ADDRESS THOSE DISPARITIES. SO I WOULD SAY IF THERE'S TO PULL THAT INFORMTION IN ABOUT WHO IS SUFFERING FROM IT, ARE WE TRACKING RACIAL AND ETHNIC DAT AND IF WE ARE NOW, THEN MAYBE THAT'S SOMETHING WE NEED TO START DOING. >> THANK YOU. THERE ARE A NUMBER OF PEOPLE WAITING TO ASK QUESTIONS BUT I AN OPPORTUNITY TO ANSWER BEFORE WE MOVE ON. SO BARBARA. >> SO I WOULD TAKE--I AGREE AND COMMUNITY ENGAGEMENT IS HUGELY IMPORTANT. I DO THINK THAT TO YOUR QUESTION STEPHEN, WE DON'T HAVE EVIDENCE THAT DOING TRIALS RIGHT IS MORE EXPENSIVE, IF YOU PLAN THEM, DO THEM, AND DO THEM FROM THE OUTSET AND PREPARE FOR THEM IN A WAY THAT IS INCLUDIVE BUT IT TAKES A FRAME SHIFT AND HOW 1 THINKS ABOUT IT, I DO THINK THAT TO YOUR QUESTION, JANET, IN THE RARE CANCER POPULATION, THAT'S A GOOD REASON WHY IT MAY NOT BE THAT THE DEMOGRAPHICS ARE THE DRIVER FOR WHO GETS INTO QUOTE-UNQUOTE THE STUDY. AND THAT 1 SHOULD LOOK TO PARTICULARLY SINCE IT'S LARGELY A GENETIC ISSUE IN THE CANCER, NOT THE CONSTITUTIONAL CELLS, THAT FOR THE DAILY BASIS THEA, I PERSONALLY DON'T BELIEVE IT'S IN THE FOLLOW ON TO SAY YOU MUST PROVIDE THAT IN THE REAL WORLD SETTINGS, IT IS THE REGULATORS RESPONSIBILITY TO DECIDE WHETHER AND HOW THE DATA IS SUFFICIENT FOR APPROVAL. SO I THINK IT SHOULD BE SCIENCE BASED IN THE WAY THAT WE,A PROACH THESE TRIALS. SO WE DO THINK THERE'S A ROLE FOR EACH. >> THANK YOU. OWEN, ANYTHING? >> YEAH, I WOULD ADD 2 THOUGHTS, 1--CAN EVERYONE HEAR ME OKAY. >> YES. >> YEAH. >> A FEW THINGS, JANET TO YOUR POINT, YOU WILL SEE MORE OF THIS, RIGHT? SO AS WE CONTINUE TO ADVANCE PRECISION MEDICINE AND RIGHT NOW WE'RE SEEING THIS IN TARGETED THERAPEUTICS IN CANCER RIGHT, WHERE WE'RE FOCUSING ON RECEPTORS AND MARKERS, RIGHT, YOU WILL SEE THESE, YOU KNOW, YOU MIGHT CALL THEM RARE NOW, WITH THESE SMALLER POPULATIONS, RIGHT? VERY PARTICULAR RUNG CANCER THAT HAS A--LUNG CANCER THAT HAS A PARTICULAR RECEPTOR SO WE WILL SEE THESE SMALLER POPULATIONS MORE AND MORE. AND I THINK THERE SHOULD BE SOME ALLOWANCE FOR THIS BALANCE OF SMALL POPULATION AND I THINK TO BARBARA'S POINT EARLIER, YOU JUST--YOU KNOW IN THE STATISTICIANS IN THE CALL CAN PROBABLY SPEAK TO THIS MORE, BUT YOU KNOW GIVEN SMALLER POPULATIONS, AND SMALLER DIFFERENCES, YOU ARE JUST NOT GOING TO HAVE ENOUGH REPRESENTATION TO MAKE A STATISTICAL OR AT LATEST LOOK AT THIS THING STATISTICALLY, RIGHT? THAT DOESN'T CHANGE THE POLICY PERSPECTIVE BUT FROM A STATIST CALIPER SPECTIVE, IT DOESN'T DO MUCH FOR US, THAT SAID, YOU KNOW I THINK PART OF THE CHALLENGE IS OFTEN SELF-INFLICTED RIGHT? WE--THIS IS NOT A RESOURCE ISSUE, RIGHT? BARBARA'S POINT OF ASKING THE QUESTION, RIGHT, IS THE PRETTY SIMPLE THING, YOU JUST HAVE TO DECIDE AS AN IRB OR IRB ADMINISTRATOR, THE 15 QUESTIONS I HAD PLANNED TO ASK, HAD TO TAKE 1 OFF AND PUT THE 1 ABOUT YOU KNOW APPROPRIATE REPRESENTATION ON. I MEAN--AND I DON'T WANT TO BE--THAT'S NOT AN INSTITUTION DECISION BUT IT'S A PROCESS DECISION THAT BUT THAT IS PART OF THIS PROCESS AND THAT PART OF THE CHALLENGE WE HAVE IN RESEARCH AND THE OTHER PART IS WHERE WE LOOK, RIGHT? SO WE WERE ADVISING A COMPANY THAT DID A COVID STUDY, THEY HAD NEVER WORKED WITH HOWARD UNIVERSITY BEFORE. HOWARD UNIVERSITY, BLACK MEDICAL SCHOOL, BLACK COLLEGE IN D. C. HAS BEEN DOING RESEARCH FOR PROBABLY A HUNDRED YEARS, THEM NOT WORKING WITH HOWARD ISN'T A HOWARD THING, RIGHT? IT'S AN US THING, IT'S A RESEARCHER THING, RIGHT? SO THINKING THROUGH WITH WHOM WE WORK, RIGHT IN AND THOSE, JEN TO YOUR POINT, IF IF YOU ARE ONLY GO TO HAVE 5 SITES THOSE ARE THE REEL KEEPSAKESY DID CISIONS BUT YOU IF YOU GO TO THE SAME SITES YOU GO TO OVER 30 YEARS THAT RETURN CERTAIN RESULTS IN TERMS OF ETHNIC DIVERSITY, THOSE ARE SOMETIMES UNCOMFORTABLE CONVERSATIONS YOU MIGHT HAVE TO HAVE WITH THE PARTNER YOU HAVE FOR 25 YEARS BECAUSE YOU HAVE TO--TRANSITION THEM OUT AND BRING SOMEONE IN THAT YOU KNOW MIGHT PRODUCE A DIFFERENT POPULATION, SO THOSE ARE SOME THINGS, YOU KNOW WE MIGHT WANT TO THINK THROUGH. >> THANK YOU. >> JANET DID YOU HAVE A FOLLOW UP. >> YES, JUST AN ADD TO THAT, IN THE SPACE OF RARE GENOMIC DRIVEN CANCERS, IT'S VERY HARD TO GET BIOMARKER TESTING DONE OUTSIDE OF THE MAJOR ACADEMIC CANCER CENTERS SO A LOT OF THE PEOPLE THAT WE MIGHT WANT TO ATTRACT TO THESE CLINICAL TRIALS IN ORDER TO INSURE DIVERSITY AREN'T GETTING TESTED AND DON'T EVEN KNOW THEY'RE ELIGIBLE. SO AND THEY MAY NOT HAVE ACCESS TO THE DRUG AFTERWARDS DEPENDING ON THEIR MEDICAL CARE PLAN, SOME OF THESE DRUGS ARE $15,000 A MONTH AND UP, SO WE ALSO NEED TO CONSIDER IF WE DO MANAGE TO GET A DIVERSE POPULATION IN THE CLINICAL TRIAL ARE THEY GOING TO HAVE ACCESS TO THE DRUG AFTER IT'S APPROVED? >> I THINK THAT'S FAIR AND I WOULD ARGUE WE SHOULDN'T NOT HAVE THAT POPULATION IN THE STUDY BECAUSE OF THESE FOLLOW ON CHALLENGES. RIGHT? SO, YOU KNOW WE'RE GOING TO LIVE IN THIS IMPERFECT WORLD FOR SOMETIME AND I THINK TO YOUR POINT, PART OF THE ISSUES AS STEPHEN MENTION INDEED THE INTRO, I WORK WITH STANFORD AND STANFORD MAJOR ACADEMIC CENTER HERE ON THE WEST COAST REALIZES THAT THEY ARE PART OF THE PROBLEM, RIGHT? THERE'S A COMMUNITY IN EAST P A LO ALTO WHICH IS BLOCKS AWAY FROM STANFORD THAT A'S MINORITY COMMUNITY THAT JUST DOESN'T FEEL COMFORTABLE GOING TO STANFORD FOR THESE STUDIES. SO I THINK WE HAVE TO OWN AS PART OF THE RESEARCH COMMUNITY WHAT WE CAN DO DIFFERENTLY, AND IT'S NOT JUST A--PEOPLE WORKING 9-5 HOURLY WAGES, DON'T HAVE INSURANCE, WE SPEND A LOT OF TIME TALKING ABOUT WHAT I CALL THE DEMAND SIDE OF THE ISSUE VERSUS THINKING ABOUT THE SUPPLY SIDE. YOU KNOW US AS THE SUPPLIERS OF RESEARCH OPPORTUNITY WHAT WE CAN DO BE DOING DIFFERENTLY. >> THANK YOU. >> WALTER IS NEXT AND THEN CONSWALE O. >> I WAS GOING TO BUILD A BIT ON JANET'S POINTS WHICH I THINK ARE REALLY WELL MADE AND I WOULD JUST POINT OUT THE OBVIOUS WHICH IS THAT [INDISCERNIBLE] WITHIN SACHRP IS 1 FACET OF A SOCIETY IN WHICH THERE ARE WIDE SPREAD INIQUITIES, THERE ARE INIQUITIES WITH RESPECT TO ACCESS TO CARE, SO THAT AS JANET WAS POINTING OUT, THAT THERE ARE INDIVIDUALS WHO MAY HAVE A PARTICULAR DISEASE THAT IS THE FOCUS OF RESEARCH WHO DO NOT MAKE THEIR WAY TO A MAJOR ACADEMIC MEDICAL CENTER WHERE RESEARCHER IS CONDUCTED ON THAT TARGET. AND I TAKE STEPHEN'S POINT THAT THERE IS A RISK OF DEVELOPING A NUMBER OF PROCEDURES FOR--TO ADDRESS THIS ISSUE WITHIN AN IRB FRAMEWORK THAT IS GOING TO BE BURDENSOME BUT WHICH DO NOT NECESSARILY GET AT THE HEART OF THE PROBLEM WHICH HAS TO DO WITH SOME BASIC ISSUES AROUND ACCESS TO CARE. AND I WOULD POINT OUT, I AGREE WITH OWEN THAT YOU KNOW THE--FOR THESE RARE CANCERS, THERE MAY BE--IT MAY NOT BE MEANINGFUL TO DO SUBANALYSIS BECAUSE THEY'RE NOT STAT STATISTICALLY MEANINGFUL AND I WOULD ACKNOWLEDGE THE REPORT THAT THE VMRC REPORT WHICH DOES ACCOUNT FOR JUSTIFICATION FOR NOT BEING AS--NOT ENROLLING AS DIVERSE POPULATIONS AS MIGHT BE AFTER THE ACCIDENT DEAL IN THIS PARTICULAR SETTINGS AND THEN THE FINAL POINT THAT I MAKE IS THAT FROM A PRIVATE SECTOR PERSPECTIVE IS NOT IN DEVELOPING NOVEL PHARMACEUTICAL PRODUCTS BUT THERE IS A SENSE OF URGENCY. IT'S A COMPETITIVE FIELD AND THERE ARE MANY--TYPICALLY MANY COMPANIES WHO ARE SORT OF TRYING TO BECOME THE FIRST TO MARKET WITH A NEW PRODUCT ADDRESSING AN UNMET MEDICAL NEED. AND SO--IT ALLOWS FOR EFFICIENT DEVELOPMENT OF IMPORTANT PHARMACEUTICAL INTERVENTIONS. >> THANK >> I DIDN'T HEAR A REAL QUESTION IN WALTER'S COMMENT. I DO THINK THAT IT'S NOT TO HAVE THOSE TRIALS. I THINK THE ANSWER IS MAKING SURE THAT WE INCLUDE THE COMMUNITY PHYSICIANS THAT WE THINK ABOUT HOW TO MAKE THIS MORE HOLISTIC. THERE IS SORT OF AN ETHICAL PRINCIPLE IN POST TRIAL MEDICINE BUT NOT TO SOCIETY IN GENERAL, SO WE HAVE GOT A BIG PROBLEM. I DO THINK, HOWEVER, THAT IF WE LOOK AT SACHRP'S REMAND, IT'S NOT NECESSARILY TO FIX SOCIETY. YOU CAN POINT IT OUT, BUT IT AIN'T TO FIX SOCIETY. AS MUCH AS EACH OF US INDIVIDUALLY WOULD LOVE TO DO. BUT REALLY FIGURING OUT WHERE WE CAN MAKE A DIFFERENCE AND HOW. AND ALSO, I THINK, TO BE COMFORTABLE HOLDING EACH OTHER ACCOUNTABLE FOR WHAT WE CAN DO AND THEREFORE, I THINK, YOU KNOW IRBs AND HUMAN RESEARCH PROTECTION PROGRAMS AND SITES AND INSTITUTIONS DON'T GET A PASS. THEY DON'T GET A PASS WHEN THEY DON'T PUBLISH THEIR DEMOGRAPHICS OR WHEN THEY PROMISE TO DELIVER X DIVERSE SORT OF GROUPS FOR CLINICAL RESEARCH AND THEN FAIL TO. SO, THERE IS A WHOLE SORT OF SERIES OF STEPS WE COULD BE TAKING, AND YES, IT'S NOT GOING TO GET FIXED OVERNIGHT; BUT IF WE DON'T START DOING THAT TOGETHER, WE WON'T BE IN A DIFFERENT PLACE A YEAR FROM NOW, OR 5. >> ANYTHING ELSE? >> YES, SO THIS IS JUST ADDING ON TO THAT POINT. I THINK IT'S THE UNDERSTANDING THAT IRB RESEARCH [ INAUDIBLE ] FROM STRUCTURAL EQUALITY. AND WHEN WE LOOK AT SOME OF THE ACADEMIC MEDICAL CENTERS, HOW THEY WORKED AT SOME OF THE BEST IN THE COUNTRY, THAT PART OF THE RELATIONSHIP BUILDING THAT NEEDS TO HAPPEN IS ACTUALLY THERE, RIGHT? AND AS YOU'RE TURNING AWAY PEOPLE FROM CARE, AS THEY FEEL LIKE THEY ARE NOT BEING VALUED, YOU CAN NOT THEN TURN AND SAY, HEY, WE HAVE A RESEARCH STUDY THAT WE WANT YOU TO PARTICIPATE IN. AND I THINK, TO ME, THAT IS JUST CRYSTALIZED WITH THE WHOLE COVID-19 EXPERIENCE. WE HAVE SPENT MONTHS AND MONTHS TURNING AWAY RACIAL AND ETHNIC MINORITIES FROM TESTING AND TREATMENT AND NOW WHEN WE WANT TO ROLLOUT A COVID-19 VACCINE, WE SAY, HEY, ALL OF A SUDDEN WE NEED YOU. AND SO WHAT WE NEED TO DO IS TO THINK ABOUT THAT. FOR ME, PART OF THE TOOL IS REALLY GETTING PEOPLE FROM THE RESEARCH SIDE, THE TREATMENT SIDE AND PEOPLE WITHIN THE COMMUNITIES THAT THEY ARE OFTEN LOCATED IN, WHICH IS OFTEN IN POOR NEIGHBORHOODS, TO WORK TOGETHER TO UNDERSTAND THAT WE ARE A PART OF A COMMUNITY. AND SO, I WOULD SAY THAT FOR ME, AS YOU MENTIONED, THAT THERE IS COMPETITION TO ROLLOUT NEW DRUGS, NEW VACCINES, BUT IT'S NOT GOING TO WORK IF A MAJORITY OF THE POPULATION ONE, DOESN'T WANT TO TAKE IT BECAUSE THEY DON'T TRUST IN YOU AND DOESN'T PARTICIPATE AND THEN IT DOESN'T WORK. SO WHAT I'M REALLY PUSHING US TO DO IS TO TAKE OUR ROLE IN THIS AND TO CONNECT WITH THE COMMUNITY THAT IS EXPERIENCING THAT SO WE CAN ADDRESS THESE ISSUES TOGETHER. SO, I'LL STOP THERE. >> THANK YOU. OWEN? >> JUST TO BUILD A LITTLE BIT ON A POINT THAT WAS MADE AND WAS MADE EARLIER. THIS NOTION OF WHAT IS COMMUNITY-BASED PARTICIPATORY RESEARCH? I WOULD ARGUE IT GOES BEYOND HAVING AN ADVISORY BOARD. IT IS REALLY HAVING PEOPLE IN THE COMMUNITY AS PART OF THE RESEARCH DECISION-MAKING PROCESS. AND I WILL LET YOU KNOW, THE SUCCESS OF THE STUDY THAT I TALKED ABOUT EARLIER WAS REALLY, I THINK, A BIG PART OF THAT WAS, WE HAD FOCUS GROUPS TO HELP UNDERSTAND -- FIRST THE POPULATION OF BLACK MEN. AND WE HIRED ABOUT 3 OR 4 OF THEM AS FIELD RESEARCHERS. AND ONE OF THEM WAS A RESEARCH LEAD AND WOULD BE SITTING WITH US MAKING THESE DECISIONS. AND, THE NOTION OF DOING RESEARCH IN A BARBERSHOP SEEMS FINE NOW, BUT FOUR YEARS AGO WHEN WE WERE PLANNING THIS, IT'S LIKE, WHERE DO THEY SIT? HOW DO THEY CONSENT PEOPLE? AND SO, YES, I GO IN AND OUT EVERY TWO WEEKS TO THE BARBERSHOP TO GET MY HAIRCUT, BUT THE INDIVIDUALS FROM THE COMMUNITY HELPED US THINK THROUGH THIS. IT IMPACTED OUR RESEARCH DESIGN. NOT ONLY THAT, IT IMPACTED -- AND WHEN I SAY DESIGN, THE STRUCTURE OF HOW WE DID IT. BUT IT ALSO IMPACTED THE QUESTIONS TWEE ASKED IN THE RESEARCH SURVEY. AND THIS ISSUE OF FLU, THE FLU SHOT. SO THESE WERE REAL ISSUES THAT I THINK YOU GO BEYOND THIS ADVISORY BOARD AND HAVE FOLKS HELPING YOU MAKE THE DECISIONS. SOMETIMES DISAGREEING WITH YOU AND ARGUING WITH YOU ABOUT THAT. SO THIS IS, I THINK, WHERE WE NEED TO GO AND GET TO. AND SOMETIMES THE ACADEMIC MEDICAL CENTERS DON'T THINK ABOUT IT THAT WAY. THEY THINK THAT THE BEST THING IS HAVING A CANCER ADVISORY BOARD THAT MEETS ONCE A QUARTER OVER DINNER AND YOU GET SOME IDEAS AND YOU MOVE ON. AND THAT IS A START, AND I'LL JUST SAY IT'S A START. IT'S NOT WHERE YOU NEED TO BE IN TERMS OF REALLY BEGINNING TO IMPACT RESEARCH. >> THANK YOU. IN THE INTEREST OF TIME, THERE ARE TWO PEOPLE WHO ARE STILL WAITING TO ASK QUESTIONS. CONSUELO AND LESLIE. I'M GOING TO TAKE THOSE QUESTIONS AND THEN WE'RE GOING TO HAVE TO MOVE ON FROM THE DISCUSSION. SO CONSUELO? >> THANK YOU TO EACH OF YOU FOR SHARING YOUR THOUGHTS AND YOUR PRESENTATIONS. I HAD A FEW NOTES OF THINGS AND SO SINCE WE ARE RUNNING OUT OF TIME, I WON'T ASK ALL OF MY QUESTIONS, BUT WE'LL SAY JUST POINTS THAT I THINK SOME OF THE THINGS YOU RAISED ARE IMPORTANT, AT LEAST IN MY MIND ACROSS THE DIFFERENT PRESENTATIONS THAT WE NEED TO ADDRESS, AND SO, I THINK THERE WAS SOME CONFLATION BETWEEN RACE AND ANCESTRY THAT IS IMPORTANT FOR THERE TO BE A ROLE FOR QUESTIONS THAT PERHAPS THE IRB IS NOT RESPONSIBLE FOR VETTING THOSE THINGS BUT THERE SHOULD BE A CLEAR DEFINITION OF RACE, ETHNICITY AND A STUDY PROPOSAL HOW THEY ARE USING IT AND HOW THAT IS DIFFERENT FROM ANCESTRY. SO WHETHER OR NOT IT'S SELF-IDENTIFICATION, WHETHER OR NOT IT'S PULLED FROM THE EHR, ALL OF THOSE THINGS I THINK THERE NEEDS TO BE SOME STANDARDIZATION AROUND THAT. I THINK A LOT OF WHAT I HEARD WAS ABOUT DIVERSITY IN TRIALS, WHICH I THINK IS DIFFERENT, IF NOT COMPLETELY DIFFERENT, AT LEAST DIVERSITY IS ONLY SOME PART OF JUSTICE IN RESEARCH. AND SO, I'D LOVE TO HEAR YOUR THOUGHTS ABOUT HOW WE REALLY IDENTIFY INJUSTICE IN RESEARCH BEYOND WHO IS PARTICIPATING. AND AGAIN, SOME OF THAT WE ARE HEARING MORE ASSET-BASED APPROACHES WITH INVOLVING AND ENGAGING COMMUNITIES AND REALLY VALUING THEIR INPUT. I THINK RIKIA WAS VERY MUCH FOCUSED ON REALLY EQUITY AND THINKING THROUGH WHAT IS MUTUALLY BENEFICIAL TO COMMUNITIES. BUT I THINK BROADLY, SOME OF THAT WILL BE A CHALLENGE TO IMPLEMENT IN HOW MOST CLINICAL TRIALS ARE DONE. SO IF YOU HAVE THOUGHTS ON SPECIFICALLY JUSTICE BEYOND DIVERSITY. >> I'LL JUST BRIEFLY SAY THIS IN THE INTEREST OF TIME. AND THANK YOU CONSUELO FOR THAT QUESTION AND THE COMMENT BEFOREHAND. I THINK IF WE GET TO THE POINT WHERE PEOPLE IN A COMMUNITY ARE ACTUALLY COMING UP WITH THE RESEARCH QUESTIONS, RIGHT? THAT, I THINK, IS THE GOAL. BECAUSE IF WE ARE DOING RESEARCH WITH OR IN CONJUNCTION WITH THE COMMUNITY, THEY HAVE, I THINK, AND I FOUND -- AND MAYBE THEY CAN'T ARTICULATE IT IN A NEW ENGLAND JOURNAL KIND OF WAY LIKE MANY OF US CAN, BUT THEY REALLY DO SPEAK TO WHAT ARE THE REAL ISSUES IMPACTING COMMUNITIES AND CAN HELP US IDENTIFY SOME OF THE OBSTACLES. SO TO ME, GETTING TO THIS NOTION OF JUSTICE, THAT WILL BE, I THINK, PART OF THE ENVIRONMENT THAT WE SEE. THAT IS JUST PART OF THE NORM. >> SO, LET ME ADDRESS THE FIRST PART SINCE OWEN DIDN'T. I COULDN'T AGREE MORE THAT WE NEED BETTER TOOLS TO COLLECT THE DATA AND STANDARDIZE THOSE TOOLS FOR BOTH WAYS OF ASKING AND HOW WE COLLECT IT AND IN ORDER TO DEVELOP A BETTER UNDERSTANDING OF SORT OF THE -- EVEN USING OBSERVATIONAL DATA, HOW THESE IMPACT AND HOW WE CAN DISAMBIGUATE THE DIFFERENT SORT OF PATHOPHYSIOLOGIC OR CAUSATIVE OR CORRELATIVE ISSUES HERE. AND WE DON'T HAVE THAT DATA. WE DON'T EACH HAVE THE STANDARDIZED WAY OF ASKING. AND WE HAVE BEEN REVIEWING THIS FOREVER, AND WE DON'T HAVE THAT AT ALL FOR LGBTQI. WE DON'T COLLECT IT UNLESS THAT'S THE OBJECT OF THE RESEARCH ITSELF. SO WE HAVE GOT THIS PROBLEM OF DATA AND FINDING RESPECTFUL WAYS OF COLLECTING THAT FROM PEOPLE QUICKLY. AND THERE HAS BEEN SOME WORK IN SOCIAL DETERMINANTS OF HEALTH, BUT IN DRUG DEVELOPMENT TRIALS, WE ALMOST NEVER COLLECT IT. IT'S ALSO, TO ME, VERY MUCH A CASE-BASED ANALYSIS OF WHEN IT IS ESSENTIAL TO INSIST UPON BOTH SORT OF HOW MUCH INVOLVEMENT IS NECESSARY TO DO A FAIR AND JUSTICE EQUITY FOCUSED-TRIAL. I THINK THAT ETHICS EMBEDS EQUITY IF YOU'RE GOING TO DO ETHICS RIGHT. AND THEREFORE, THAT'S THE LENSE THAT WE SHOULD BE APPLYING. BUT YOU DON'T APPLY IT AS A SORT OF HAMMER. IT'S GOT TO BE CONTEXTUALIZE TO THE POINT THAT WAS MADE EARLIER. IN THE RARE DISEASE COMMUNITY, WE ARE NOT GOING TO BE ABLE TO DO THAT EASILY. WE DON'T WANT TO PREVENT IT, BUT IT DOESN'T MEAN WE CAN'T DO IT AS A COMMUNITY OVER TIME. THAT'S A PRETTY IN COHERENT ANSWER. THAT'S WHERE I AM. >> I'D SAY YES TO BOTH. I THINK FOR ME, THIS IS MEANINGLESS IF YOU'RE NOT ALSO GOING TO APPLY SOCIAL DETERMINANTS OF HEALTH, BECAUSE WE DON'T HAVE A GREAT DEFINITION OF WHAT RACE IS. ONE IS SELF-IDENTIFICATION AND [ INAUDIBLE ] FOR ME AND FOR COLLECTING THAT INFORMATION, YES, WE NEED TO COLLECT, HAVE YOU EXPERIENCED RACISM? BECAUSE WHAT I THINK YOU WILL FIND IS THAT IT IMPACTS PEOPLE WE DON'T THINK IT DOES. LIKE WHITE, POOR PEOPLE AND ACROSS-THE-BOARD. AND SO THEN IT LEADS TO BETTER OUTCOMES AND BETTER RESEARCH. BUT I THINK THAT JUST GOING BACK TO COMMUNITY PARTICIPATORY RESEARCH, WHETHER IT IS DONE WELL, TO ME RESEARCH HAS TO BE DONE DIFFERENTLY. AND I KNOW IT'S HARD BECAUSE IT PUSHES US BEYOND WHAT WE ARE COMFORTABLE WITH, BUT I THINK WE REALLY NEED TO BEGIN TO PARTNER WITH PEOPLE IN THE COMMUNITY IF WE ARE STUDYING PEOPLE IN THE COMMUNITY. IT MAKES NO SENSE TO ME LIKE IF WE ARE TALKING ABOUT DOING SICKLE CELL RESEARCH, NO THE TO INVOLVE SOMEBODY WHO HAS SICKLE CELL ON THE DESIGN BECAUSE THEN THEY CAN ANSWER QUESTIONS ABOUT IT AND HELP YOUR RESEARCH DESIGN, HELP YOU FIGURE OUT WHAT YOU NEED TO TAKE INTO CONSIDERATION. OTHERWISE, YOU START DOING THE RESEARCH AND YOU HAVE TO STOP HALFWAY IN BECAUSE YOU REALIZE, I DIDN'T KNOW. I SHOULD HAVE ACCOUNTED FOR THAT. SO I WOULD SAY, I'M PUSHING US BEYOND WHAT WE ARE COMFORTABLE IN TO SOMETHING NEW BECAUSE THIS IS A GREAT TIME TO DO SOMETHING NEW AND BETTER AND REALLY CONNECT EQUITY TO THE WORK WE ARE DOING. >> THANK YOU. SO, LESLIE? >> I DON'T HAVE A QUESTION FOR OUR PANELISTS, BUT I WANT TO THANK EACH OF THEM, AND I THINK WHAT I REALLY APPRECIATED FROM EACH OF THE DIFFERENT PERSPECTIVES THAT YOU BROUGHT TODAY WAS A RESOUNDING YES THAT WE COULD ASK IRBs TO TAKE ON SOME OF THIS WORK. AND I APOLOGIZE STEPHEN, IF NOT IS NOT THE TIME TO TALK ABOUT THE DOCUMENT WE HAVE BEFORE US, BUT THAT WAS THE ONE THING IN THE DOCUMENT THAT I FELT SLIGHTLY DISAPPOINTED IN. IT WAS SOMETIMES, AND I THINK BARBARA YOU SAID, WE CAN'T GIVE IRB A PASS. USING THAT, THERE ARE TIMES WE WERE LIKE NOT STEPPING UP IN THE WAY THAT WE COULD. AND I DO THINK -- I SAID THIS LAST TIME. I THINK HISTORICALLY, WE HAVE JUST NOT GIVEN AS MUCH ATTENTION TO JUSTICE AS A PRINCIPLE AND ARTICULATING HOW WE IN FACT IMPLEMENT THAT. AND I THINK WE HAVE HAD REALLY GREAT EXAMPLES OF HOW TO MOVE FORWARD AND KNOWING WE ARE NOT GOING TO SOLVE ALL OF THE PROBLEMS IN WHICH WE ARE EMBEDDED, BUT BEING ABLE TO TAKE A STEP UP AND MOVE THINGS FORWARD. I JUST WANT TO THANK THE PANEL FOR MAKING THAT CASE SO WELL FOR ALL OF US AND THAT WILL INFORM OUR DECISIONS GOING FORWARD. SO THANK YOU. >> CAN I MAKE ONE POINT TO THAT? I JUST WANT TO SAY THAT IN THE WORLD OF SINGLE IRB, AND I'M EMBEDDED IN IT RUNNING SMART IRB, THIS BECOMES EVEN MORE COMPLICATED. IF YOU HAVE ONE IRB THAT SORT OF SAYING THIS IS IMPORTANT FOR US, AND YOU HAVE THE OTHER 12 SAYING, WELL, YOU KNOW THEN WE WON'T GO THERE; IT'S GOING TO BE -- IT'S GOING TO MAKE A SYSTEMIC -- IT'S GOING TO CAUSE A SYSTEMIC PROBLEM. AND WE SHOULD BE, THEREFORE, DEPENDENT ON SACHRP GUIDANCE TO SAY, THIS IS THE RIGHT THING TO DO. IT CAN BE DONE. AND ONE OF THE WAYS OF DOING IT IS TO EMBED IN THE PROCESS SOME OF THESE QUESTIONS AND APPROACHES VALUING JUSTICE, AND THEN DOING A CASE-BASED ANALYSIS THAT ONLY THE IRB CAN DO. >> SO THANK YOU. THERE IS STILL A NUMBER OF PEOPLE WITH QUESTIONS. WE HAVE 15 MINUTES LEFT IN THIS SESSION. MY TASK AT THE END, ONE OF MY TASKS AT THE END OF THIS SESSION WILL BE TO RE-DO THE DOCUMENT. SO, IT'S PERSONALLY IMPORTANT TO ME. SO I WILL ASK, DOUG AND JANET BOTH HAVE THEIR HANDS UP. IF THEY ARE NOT SPECIFICALLY PANEL QUESTIONS, IF YOU COULD HOLD THEM, I WOULD APPRECIATE THAT. IF NOT, I UNDERSTAND BECAUSE OBVIOUSLY WE HAD THE PANEL WITH US FOR A SHORT TIME. >> WE ALL HAVE E-MAIL ALSO. SO FEEL FREE. >> YES. IT'S ALWAYS A QUESTION ABOUT HOW MUCH WE CAN DO OUTSIDE, WHICH IS REALLY ANNOYING AT TIMES. SO YOU BOTH STILL HAVE YOUR HANDS UP. SO I'LL GO -- I THINK DOUG FIRST AND THEN JANET AND PLEASE KEEP IN MIND THAT I WOULD LIKE TO HEAR SOME COMMENTS ON THE PAPER SO I KNOW WHAT TO DO NEXT. >> MINE IS -- I GUESS I WOULD BE INTERESTED IN HEARING IF ANYBODY ON THE PANEL HAS COMMENTS, BUT WHEN WE TALK ABOUT SORT OF INCLUSION AND JUSTICE, THE ONE CATEGORY I HAVEN'T REALLY HEARD MENTIONED IS INDIVIDUALS FOR LANGUAGE. AND IT SEEMS LIKE THAT IS A REALLY IMPORTANT GROUP TO THINK ABOUT BECAUSE IT'S SOMEWHAT EXPENSIVE TO INCLUDE THEM IN RESEARCH, AND THERE ARE SOME ADDITIONAL HURDLES IN TERMS OF MAKING SURE THAT THEY TRULY UNDERSTAND WHAT THEY ARE BEING ASKED TO DO AND SO ON. BUT IT ALSO DOESN'T SEEM FAIR NOT TO INCLUDE THEM. SO I JUST WOULD BE INTERESTED IN HEARING WHAT PEOPLE THINK ABOUT THAT. >> BARBARA? >> SO WE ARE DOING AN ANALYSIS OF THAT NOW AND WE STARTED THAT OF HOW MANY TRIALS REQUIRE ENGLISH PROFICIENCY AND ALSO THE LEGAL BASIS OF WHETHER THAT IS GOING TO BE ACCEPTABLE. AND I WOULD SAY DEPENDING -- A LOT OF THE JUSTIFICATION FOR SAYING ENGLISH ONLY IS, NOT EVEN THERE. BUT SOME OF IT IS, THIS INSTRUMENT IS ONLY VALIDATED IN ENGLISH. AND MY FEELING IS, LOOK, THE FDA DOESN'T APPROVE THINGS FOR ENGLISH SPEAKERS. SO, LIKE WHY ARE WE SAYING THAT'S OKAY? AND YES, I THINK WE SHOULD DOE LESS LITTLE RESEARCH AND BETTER RESEARCH OVERALL. AND YES, IT'S GOING TO COST A LITTLE MORE MONEY BUT WE ARE MULTILINGUAL SOCIETY. CANADA CAN GET OVER THEMSELVES, WE SHOULD GET OVER OURSELVES. AND I ALSO THINK THERE IS A SOUND LEGAL BASIS FOR SAYING THIS IS NO LONGER ACCEPTABLE. SO WE ARE ACTUALLY WORKING ON THAT. >> OWEN? >> WHAT HAPPENS PRACTICALLY AS WELL, IT'S NOT THIS DEFINITIVE ENGLISH ONLY, RIGHT? BUT DEFACTO THERE IS NO TRANSLATION. SO IF YOU'RE NOT PROFICIENT IN ENGLISH, YOU JUST CAN'T PARTICIPATE. SO THAT IS WHAT -- IT'S JUST NO BUDGETED FOR IT IT'S JUST NO, WE ARE NOT TRANSLATING IT INTO ANYTHING. SO, WE NEED TO FIGURE OUT HOW WE SOLVE THAT ISSUE BECAUSE PRACTICALLY FOLKS ARE JUST -- I GUESS TECHNICALLY NOT MAKING A DECISION, BUT YOU ARE PRACTICALLY MAKING THE DECISION NOT TO BE ABLE TO RECRUIT. BECAUSE YOU CAN'T BE INFORMED ABOUT A RESEARCH STUDY IF YOU CAN'T READ THE PAPER, THE WORDS, RIGHT? IT'S NOT JUST TRANSLATION OR TRANSCRIPTION. I THINK IT'S ALSO MAKING SURE THAT IT IS UNDERSTANDABLE. WHEN I SERVED ON THE QUORUM IRB, IT STRUCK ME THAT THE -- WHEN THERE WERE KIDS INVOLVED, NOT THE INFORMED CONSENT -- I'M BLANKING ON THE DOCUMENT. >> ASCENT. >> THE ASCENT DOCUMENT MADE PERFECT SENSE. THIS SHOULD BE THE INFORMED CONSENT DOCUMENT. IT WAS JUST CRYSTAL CLEAR. IT WAS RARELY ISSUES AROUND EDUCATIONAL LEVELS. SO THERE ARE WAYS NOT JUST WITH OTHER LANGUAGES, BUT I THINK BETTER WAYS TO COMMUNICATE THE STUDY MATERIALS GENERALLY. >> JANET, LAST QUESTION. >> I MAY BE TREADING DANGEROUSLY CLOSE TO BRIDGING BETWEEN THE QUESTION FOR THE PANEL AND INPUT FOR YOUR DOCUMENT, STEPHEN. >> THAT'S GOOD. >> SO, THERE ARE MANY PATIENTS, LIKE MYSELF, WHO HAVE BECOME EDUCATED ABOUT THE RESEARCH PROCESS AND THERE ARE FORMAL PROGRAMS FOR TRAINING RESEARCH ADVOCATES. SOME OF THEM WOULD VERY MUCH LIKE TO BE INVOLVED IN HELPING TO DEVELOP THE RESEARCH PROTOCOLS TO HELP ADDRESS SOME OF THESE ISSUES. AND INCLUDING PATIENTS FROM THE AFFECTED COMMUNITIES WOULD INVOLVE THAT. HOWEVER, I HAVE OCCASIONALLY RUN INTO PROBLEMS WHERE RESEARCHERS HAVE TOLD ME TO MY FACE THAT YOU ARE A POTENTIAL PARTICIPANT AND THE IT'S A CONFLICT OF INTEREST FOR YOU TO ADVISE THE STUDY DEVELOPMENT. I'M WONDERING, HOW FORCEFULLY WE WANT TO WORD IT IN THE SACHRP DOCUMENT THAT WE WANT INFORMED PATIENTS INCLUDED IN THESE COMMUNITIES TO HELP GUIDE THE DEVELOPMENT OF THESE STUDIES? >> THANK YOU. SO I'M GOING TO USE THE CHAIR'S PRIVILEGE AND ACTUALLY ANSWER THAT FROM MY PERSPECTIVE. SO I JUST PARTICIPATED IN ANALYSIS OF COVID STUDIES LOOKING AT THE OUTCOME VARIABLES FOR THE STUDIES PUBLISHED IN CLINICALTRIALS.GOV. AND WE LOOKED IN JUNE AND I DON'T KNOW HOW MANY HUNDREDS OF STUDIES THERE WERE. NOW THERE ARE THOUSANDS. WE LOOKED AT STUDIES THAT SAID THEY USED THE ORDINAL SCALE T TURNED OUT THERE WERE AT LEAST 14 DIFFERENT ORDINAL SCALES. SOME WITH HIGHS AND LOWS AND ALL WITH DIFFERENT NUMBERS. BUT THEY WERE ALL CALLED THE ORDINAL SCALE. SO THERE IS THIS ISSUE ABOUT RESEARCHERS -- AND I THINK THIS UNDERLIES THIS WHOLE TOPIC. HOW MUCH IS RESEARCH SORT OF THE CREATIVITY OF INDIVIDUAL INVESTIGATORS WHO HAVE AN IDEA AND WANT TO DO SOMETHING? AND HOW MUCH IS THIS A SOCIAL ENTERPRISE THAT BASICALLY WE HAVE TO BE SPONSIVE TO THE COMMUNITIES. WE HAVE TO BE -- AND I THINK THERE IS, AT SOME POINT, ATTENTION WITH THESE THINGS. I MEAN, WITH COVID, WE HAVE DONE ALL THESE STUDIES THAT ARE GOING TO TAKE HUGE EFFORTS TO MAKE SENSE OF BECAUSE THEY WERE ALL DONE, PEOPLE WANTED TO GET COVID STUDIES OUT AND THAT'S HOW WE PRIORITIZED IN OUR ACADEMIC SYSTEM. YET, RESEARCH IS A SOCIAL PROJECT F YOU'RE NOT SOLVING A PROBLEM THAT NEEDS TO BE SOLVED, YOU'RE NOT DOING A LOT OF GOOD. SO I THINK THERE IS ATTENTION AS WE TALK ABOUT JANET OR THE COMMUNITY INPUT INTO -- AND OWEN, COMMUNITY INPUT INTO WHAT THE RESEARCH QUESTION IS INTO THE STUDY DESIGN. I THINK IT'S A CULTURE SHIFT THAT IS LONG OVERDUE, ACTUALLY; BETWEEN HOW WE HAVE DONE SCIENCE TRADITIONALLY AND HOW WE ARE GOING TO HAVE TO DO IT IN THE FUTURE. BUT IT'S NOT GOING TO BE NECESSARILY STRAIGHTFORWARD. BARBARA? >> WE JUST DID A BIOETHICS COLLABORATIVE ON JUST THIS POINT OF COMMUNITY ENGAGEMENT, PATIENT ENGAGEMENT, PARTICIPANT ENGAGEMENT, IN CLINICAL RESEARCH. AND THAT POINT WAS BROUGHT UP. I DON'T THINK THERE IS A UNIFIED SET OF DECISIONS THAT THIS IS APPROPRIATE OR NOT IN TERMS OF WHETHER A PARTICIPANT WHO -- OR A POTENTIAL PARTICIPANT WHO DESIGNS A STUDY WITH THE INVESTIGATORS, SHOULD BE EXCLUDED AND SIMILARLY SHOULD THEY BE GET PREFERENTIAL ENTRY INTO A TRIAL BECAUSE THEY WERE PART OF DESIGN. AND I THINK WHAT IS IMPORTANT IS WHETHER THE DATA CAN BE BIASED BY WHETHER SOMEBODY HAS BEEN IN A STUDY OR IN THE DESIGN OR NOT. IN THE SAME WAY THAT WE BLIND THE INVESTIGATORS TO THE WAY THAT SOMEBODY -- BUT I THINK WE NEEDED TO HAVE A PUBLIC DISCUSSION ABOUT THAT AND COME UP WITH WHAT ARE THE POINTS TO CONSIDER IN TERMS OF WHAT THE CONFLICTS ARE OR WHAT THE BIASES ARE. ,SHINE A LIGHT ON IT AND SAY, THIS IS WHY YOU CAN OR CANNOT. AND I DON'T THINK IT'S A ONE-SIZE FITS ALL. SO, I AGREE WITH YOU. >> SOOWEN, DO YOU HAVE SOMETHING TO ADD? >> I SHOULD MUTE MYSELF. >> NO, IT'S FINE. I WANT TO TAKE A MOMENT TO THANK THE PANEL. I THINK THIS HAS BEEN ENORMOUSLY VALUABLE TO ALL OF US. I HAVE GOTTEN SOME E-MAILS FROM PEOPLE WHO HAVE BEEN LISTENING IN WHO REALLY SEE -- FROM THE SUBCOMMITTEES WHO WORK ON THE DOCUMENTS AND REALLY ARE THANKFUL AS WELL. SO I THINK THIS WAS A WONDERFUL OPPORTUNITY TO RAISE AND BRING DIFFERENT PERSPECTIVES TO THE COMMITTEE. I DON'T GET A SENSE WE RAISE THINGS THAT WE DISAGREE ABOUT. BUT WE HAVE GONE INTO THEM, I THINK YOU MADE US AWARE OF THINGS THAT OR PERSPECTIVES WE MIGHT NOT HAVE INCLUDED AS FOE FORCEFULLY AS WE SHOULD. SO AGAIN, THANK YOU ALL. AND YOU'RE WELCOME TO STAY ON THE CALL. WE WERE SCHEDULED TO HAVE A BREAK IN 5 MINUTES. I WOULD ENCOURAGE ANYONE WHO NEEDS A BIOBREAK OR NEEDS TO GET A DRINK OF WATER TO JUST GO DO IT. BUT I'M GOING TO KEEP US WORKING UNTIL 3:15 WHERE WE SWITCH BACK TO BYSTANDER RISKS. JUST SO WE CAN GET SOME INPUT ON THE DOCUMENT. THIS IS OBVIOUSLY A DISCUSSION THAT IS NOT GOING END IN THIS COMMITTEE MEETING. WITH THAT, I'M GOING TO PUT UP THE DOCUMENT AND SPEND THE NEXT -- AS RAPIDLY AS I CAN, WALK YOU THROUGH IT AND THEN TAKE SUGGESTIONS. SO LET ME SEE IF I CAN SHARE. SO CAN YO SEE THE DOCUMENT? AND I CAN'T SEE WHO IS RAISING A HAND OR ANYTHING. SO YOU JUST SPEAK UP IF YOU CAN. >> YES. WE CAN SEE THE DOCUMENT. LOOKS GOOD. >> SO I'M JUST GOING TO GO THROUGH THIS. AND I PUT SOME BOOKMARKS IN. AND THEN I'M JUST GOING TO GO THROUGH IT AS QUICKLY AS I CAN AND THEN WHEN WE COME BACK, IF YOU COULD REFER TO SPECIFIC LINES, I'LL TAKE SOME NOTES ON THESE. SO THIS IS ALL JUST BACKGROUND. I THINK HERE I TRIED TO HIGHLIGHT -- OR WE TRIED TO HIGHLIGHT. I APOLOGIZE FOR THINKING OR TALKING ABOUT IT THAT WAY. I'M THE ONE WHO PUT THE FINAL DRAFT TOGETHER. BUT THERE HAS BEEN INPUT FROM THE COMMITTEE AND SO I APPRECIATE THAT -- SUBCOMMITTEES, I'M SORRY. SO BASICALLY, WHEN WE TALK ABOUT JUSTICE IN BELMONT AS WE HAVE SAID, BELMONT REALLY TALKED ABOUT DISTRIBUTED JUSTICE AND THE SOCIAL CONTEXT AND SOCIAL JUSTICE, BUT DOESN'T REALLY GIVE US THE TOOLS TO ADDRESS THAT. AND THEN -- >> STEPHEN? DO I WANT QUESTIONS AS YOU GO THROUGH OR AT THE END? >> I'M JUST TRYING TO THINK WHAT IS PRACTICAL FOR ME TO TAKE NOTES. I CAN TAKE QUESTIONS AS WE GO THROUGH. >> WHY THE NEED TO HAVE OR TO INCLUDE SOCIAL JUSTICE AS A DEFINITION? >> WELL, IT IS IN BELMONT, IN THAT SECTION THAT THEY SPEAK TO. BUT I'M OPEN TO NOT. I MEAN TO JUST TALK ABOUT DISTRIBUTEDDED JUSTICE. I THINK YOU'RE RIGHT, IN FACT, YOU CAN TELL FROM THE NUMBERING THIS HAS GONE THROUGH MULTIPLE DRAFTS BECAUSE IT'S JUST BEEN HARD TO GET MY HEAD AROUND THIS. AND I TRIED TOW MAKE IT MORE OF A ANALYTIC DOCUMENT AT THIS POINT. BUT IF WE WANT TO JUST ADDRESS DISTRIBUTED JUSTICE, I THINK IT FOLLOWS, AND MAYBE WE SHOULD JUST TAKE THAT UP. >> I THINK PEOPLE READING IT AND SEEING SOCIAL JUSTICE WILL IMMEDIATELY THINK IT IS BEYOND THE SCOPE OF THE IRB. >> OKAY. >> AND SO UNLESS WE THINK THERE IS SOME ADDITIONAL VALUE ADDED BY STATING OR GIVING A DEFINITION OF SOCIAL JUSTICE, WHICH I THINK YOU CAN CERTAINLY FIT ALL OF THIS INTO DISTRIBUTED JUSTICE. >> I GUESS THAT WAS WHERE I WAS COMING FROM, THAT IN FACT, IT IS IN THE SCOPE OF THE IRB BECAUSE IT DOES IN FACT TRANSLATE IN THE SPECIFIC CASE. BUT MAYBE WE WON'T HAVE TO SAY IT LIKE THIS, OR THIS MAY ONLY BE CONFUSING. >> I THINK WHAT YOU'RE SAYING IS THAT OUR VIEW OF DISTRIBUTED JUSTICE HAS BEEN TOO NARROW. >> RIGHT. THAT'S RIGHT. EXACTLY. >> AND I DON'T KNOW THAT YOU NEED TO SAY, TO BRING IN SOCIAL JUSTICE TO SAY THAT. >> FAIR ENOUGH. THANK YOU. OKAY, THIS IS JUST A QUOTE FROM BELMONT THAT I THINK WE ARE PROBABLY ALL FAMILIAR WITH. AND THEN JUST HIGHLIGHTING THE LANGUAGE OF WHAT IT IS ABOUT, WHAT IS CONSIDERED DISTRIBUTED JUSTICE, THE SELECTION. SO THEN JUST TRYING TO PARSE THIS OUT, DISTRIBUTIVE JUSTICE IS ABOUT THE DISTRIBUTION OF THE BURDENS AND BENEFITS UNIQUE TO EXPLICITLY TO IDENTIFY WHAT THOSE ARE. I TRIED TO GET EVERYTHING IN HERE. >> SO, STEPHEN, THIS IS SKIP. IF I COULD JUST RAISE A QUESTION. I THINK IT DOES RELAY CONCEPTUALLY TO THE LANGUAGE YOU HAVE HERE. IT'S SOMETHING I HAVE BEEN THINKING ABOUT. LET'S TAKE AS A STARTING POINT THAT -- AND I'M THINKING BIOMEDICAL RESEARCH, THAT IN FACT ONE OUGHT TO RECRUIT A POPULATION THAT IS REPRESENTATIVE OF THOSE WITH THE DISEASE SUCH THAT YOU HAVE AN APPROPRIATE DISTRIBUTION OF RACIAL AND ETHNIC GROUPS; HOWEVER WE DEFINE THEM. ONE OF THE CHALLENGES IN MY MIND -- SO THERE IS COMPETING ASSUMPTIONS. AND I PERSONALLY THINK WE HAVE TO DRILL DOWN TO THIS WHEN WE SAY TO THE IRB, WHAT DO YOU DO ABOUT A PROTOCOL? BUT I THINK IT LINKS TO THIS AND LET ME MAYBE TRY TO MAKE THAT CONNECTION AND MAYBE NOT AS ARTICULATE AS I COULD IF I COULD WRITE IT ALL OUT BUT TRY TO DO THAT AT LEAST CONCEPTUALLY. IMAGINE WE HAVE THAT TRIAL AND WE HAVE GOT THE DISTRIBUTION, THE DISEASE IS 60% CAUCASIAN, 20% ASIAN AND 20% AFRICAN-AMERICAN. BUT, THE ASSUMPTION OF THE PROTOCOL OFTEN IS THAT YOU POWER THE EFFICACY TO THAT ENTIRE GROUP, WHICH CONCEPTUALLY IS AN ASSUMPTION THAT YOU WILL NOT SEE DIFFERENCES WITHIN THAT GROUP. AND THAT'S THE ASSUMPTION. BUT THENY QUESTION IS, ARE THERE? IF YOU DO A SUBGROUP ANALYSIS, THERE IS ATTENTION THERE IN TERMS OF IF IT'S SMALL ENOUGH -- LET'S SAY IT'S FULLY REPRESENTATIVE OF THE DISTRIBUTION WITHIN THE POPULATION, SO WE ARE DOING THAT. WE ARE MAKING SURE WE RECRUITED APPROPRIATELY. BUT IF IT'S SMALL ENOUGH RELATIVE TO THE OVERPOPULATION, YOU RUN THE RISK OF MAKING AN INAPPROPRIATE INFERENCE ABOUT THAT POPULATION TO INCREASE THE DISTRIBUTION OF THAT POPULATION, BUT ON THE OTHER HAND, INCREASING THE DISTRIBUTION IS THAT NECESSARY IF IN FACT THERE IS NO EVIDENCE THAT THERE ARE IMPORTANT PHARMACOGENOMIC OR DISEASE-RELATED TARGETING DIFFERENCES THAT TRACK WITH RACE OR ETHNICITY. AND THE OTHER PROBLEM, AND JUST ONE OTHER PROBLEM, IF THAT GROUP IS TOO SMALL, IT'S FULLY REPRESENTATIVE, BUT RELATIVE TO ALL OF THOSE WITH THE DISEASE, IT'S TOO SMALL TO MAKE ANY KIND OF MEANINGFUL INFERENCE ABOUT THAT POPULATION. ONE COULD SAY THAT THEY ARE CONTRIBUTING TO THE HOWEVER ALL CONCLUSION BUT THERE IS NO MEANINGFUL DATA OR INFERENCE ABOUT THAT POPULATION IN AND OF ITSELF. AND SO, I GUESS WHAT I'M SAYING IS, UNLESS -- IF I WAS SITTING ON AN IRB, AND ALL OF THIS IS GREAT. I'M LOOKING AT THERE SAYING OKAY, I GET IT. THEN WHAT DO I DO ABOUT THIS PROTOCOL? AND A SUBGROUP ANALYSIS OR MAYBE NO SUBGROUP ANALYSIS OR NO DATA TO KNOW WHETHER THE POPULATIONS ARE THE SAME OR DIFFERENT. WHAT DO I DO? AND I THINK ULTIMATELY WE ARE GOING TO HAVE TO GET VERY CONCRETE. AND I THINK IT DOES -- SO WE CAN START WITH THE POSITION THAT YOU OUGHT TO INCLUDE, YES, BUT THEN WHAT DOES THAT MEAN AT THE PROTOCOL LEVEL? I THINK IT CAN BE A CHALLENGE. IT'S WHAT I HAVE BEEN THINKING ABOUT IN LISTENING TO THIS WHOLE CONVERSATION. >> I GET WHAT YOU'RE SAYING AND I AGREED WITH IT AND I TRIED TO DODGE IT AND I WASN'T SUCCESSFUL. >> I DON'T THINK WE CAN. >> LET ME FINISH. SO THE REASON -- WHAT I MEAN BY NA IS, THAT I REMEMBER I WAS AT AN MRCT MEETING VERY EARLY ON WHEN THIS TOPIC CAPE CAME UP AND PEOPLE RAISED THE OBVIOUS QUESTION. IF YOU'RE GOING TO POWER A STUDY TO GIVE YOU A STATISTICALLY-SIGNIFICANT ANSWER, EVERY POSSIBLE SUBGROUP ANALYSIS, WE CAN'T AFFORD TO DO THAT. I MEAN THE STUDY WILL BE HUGE. AND THEN SOMEONE WILL THINK OF A GROUP WE DIDN'T CONSIDER AND SO THERE ARE PRACTICAL SCIENTIFIC REASONS THAT YOU CAN'T DO THAT. BUT THAT'S ALSO -- AND I'M NOT SURE WE ARE ALL GOING TO AGREE ON THIS BUT I'LL TELL YOU WHERE I'M COMING FROM. I THINK THAT'S A QUESTION OF MA LIVE SENSE. SO I THINK THE ISSUE OF WHETHER YOU HAVE NO -- SOMETHING IS SAFE AND EFFECTIVE FOR FUTURE USE IN A GROUP, IS A HARM MINIMIZATION ISSUE. JUSTICE IS REALLY ABOUT WHETHER PEOPLE SHOULD HAVE THE OPPORTUNITY TO PARTICIPATE IN RESEARCH EQUALLY GIVEN THE OPPORTUNITY TO PARTICIPATE IN RESEARCH. AND I REALIZE THERE IS HUGE OVERLAP BETWEEN THOSE TWO THINGS. BUT I DON'T WANT -- WHAT I'M TRYING TO AVOID IS, I DON'T THINK WE WANT TO SAY THAT THERE ARE PRACTICAL LIMITATIONS THAT SUGGEST WE SHOULDN'T EVEN TRY TO LEVEL THE PLAYING FIELD AS FAR AS OPPORTUNITIES TO PARTICIPATE IN RESEARCH GOES. >> ONE QUICK RESPONSE. I WOULD NOT GO TO WHERE YOU JUST TOOK THAT ARGUMENT. SO, I AGREE WITH THAT, BUT I DON'T THINK THAT WE WOULD DO IRBs A SERVICE IF WE ARE NOT PROVIDING THEM VERY CONCRETE ASSESS ABOUT WHAT TO DO WITH THIS -- >> TOTALLY AGREE. I JUST WANTED TO DISENGAGE THAT FROM THE STATISTICAL QUESTION. >> BUT IT IS A STATISTICAL QUESTION, STEPHEN. I DON'T THINK YOU CAN DO THAT. AND THAT IS PRECISELY THE CONVERSTATION. IN OTHER WORDS, IF ALL WE ARE SAYING IS, THAT WE SHOULD MAKE SURE THAT WE OFFERED PARTICIPATION TO A REPRESENTATIVE GROUP AND THEN A REPRESENTATIVE GROUP HAS COME INTO THE TRIAL, IS THAT REALLY -- I MEAN THEN THERE IS NOTHING THAT TRANSLATES TO BENEFIT FOR THE POPULATION. IT'S JUST AN INDIVIDUAL'S RIGHT TO PARTICIPATE. >> I THINK THERE ARE LOTS OF BENEFITS THAT ARE JUST NOT THE ONES WE TRADITIONALLY LOOK FOR. SO, IF YOU DON'T INCLUDE THOSE GROUPS, I MEAN, I GUESS THE BOTTOM LINE IS THAT I THINK IF THAT IS OUR ONLY ARGUMENT, I'M NOTER SURE WE EVEN HAVE TO HAVE IT. BECAUSE IT'S DRIVING EFFICACY DETERMINATIONS. -- PROJECT KICKED OFF WITH THAT ISSUE. I THINK IT PIVOTED DURING IT BECAUSE IT BECAME AN ISSUE OF EQUITY. AND I THINK THERE ARE ISSUES OF JUSTICE THAT ARE SEPARATE FROM THE ISSUES OF DETERMINING SAFETY AND EFFICACY. >> STEPHEN, LOOK AT THE SENTENCE YOU HIGHLIGHTED. >> YES? >> YOU CAN NOT AVOID A DISCUSSION OF THE SAFETY AND EFFICACY OF A PRODUCT WHEN YOU'RE TALKING ABOUT THE BURDENS AND BENEFITS OF RESEARCH UNLESS YOU WANT TO ACTUALLY START TALKING ABOUT IT'S JUST AT THE INDIVIDUAL LEVEL. DO I WANT TO GO INTO IT OR NOT? THEN YOU EMASK LATED THE CONCEPT OF JUSTICE. >> SO AS I KNOW THAT THERE IS REAL OVERLAP, AND I THINK YOU'RE RIGHT THAT IF YOU CAN'T DEMONSTRATE SAFETY AND EFFICACY -- IT GETS BACK TO WHAT BARBARA TALKED ABOUT, THE DIFFERENCE BETWEEN AFFIRMATIVELY DEMONSTRATING SAFETY AND EFFICACY, VERSUS THE ASSUMPTION THERE IS NO DIFFERENCE. I THINK THERE ARE SUBTLER HARMS THAT OCCUR FROM EXCLUSION, INAPPROPRIATE AND UNNECESSARY EXCLUSION, WHICH GO FROM INABILITY TOW PARTICIPATE IN SORT OF WHAT IS SUPPOSED TO BE A SOCIAL PROJECT, TO REINFORCEMENTS THAT THIS POPULATION IS NOT CONTRIBUTING TO OUR SOCIETY IN THE SAME WAY AS WE ALL ARE AND THEREFORE WE MAY NOT BE WORTHY OF THE BENEFITS. TO -- I MEAN -- >> STEPHEN, ONE FINAL COMMENT AND THEN I'LL STOP. I AGREE WITH EVERYTHING YOU'RE SAYING. BUT I WOULD ARGUE THAT THAT IS NOT ENOUGH. AND I'M NOT SAYING I HAVE A SOLUTION TO THE PROBLEM I'M RAISING, BUT I DON'T THINK IT'S FLUFF TO JUST SAY, EVERYBODY HAD A CHANCE TO PARTICIPATE AND WE'RE GOOD. >> SO, SKIP, I THINK IT GOES BEYOND OFFERING THE OPPORTUNITY, BUT LET'S LEAVE THAT FOR NOW. I THINK WE HAVE A RESPONSIBILITY TO ENROLL. BUT LET'S SAY WE TOOK ON, WHEN YOU MENTIONED OR STARTED WITH, WHICH IS THE POWER TO ANSWER THE QUESTION FOR THESE PEOPLE. DO WE REALLY WANT TO TELL IRBs THAT EVERY STUDY HAS TO BE POWERED? >> NO! NO! I WOULDN'T GO THERE. THAT'S ABSURD. POWER IS ONE WAY TO APPROACH THE CONCLUSIONS YOU CAN GAIN FROM -- YOU DON'T NEED TO HAVE THE SUBGROUP FULLY POWERED TO BE ABLE TO DRAW A CONCLUSION ABOUT THE SUBGROUP. SO THAT'S A FALSE STARTING ASSUMPTION. >> SO, STEPHEN, I PUT IN THE CHAT BOX -- >> WHICH I CAN'T SEE. I APOLOGIZE. THE PRESENTER CAN'T SEE. >> I PASTED SOMETHING FROM THE RECENT SUMMARY STATEMENT AND IT'S A SEX-GENDER DISTRIBUTION JUSTIFIED SCIENTIFICALLY, RACE ETHNICITY JUSTIFIED SCIENTIFICALLY, AND THEN IT HAS SOMETHING ABOUT THE ANALYSIS, WHICH IS NOT APPLICABLE BECAUSE THERE WASN'T A PHASE III TRIAL. I PASTED IT THERE BECAUSE I THINK IT'S IMPORTANT THAT IT USES JUSTIFIED THERE. SO IF WE ARE TALKING ABOUT JUSTICE, THEN WE ARE TALKING ABOUT DOES THE STUDY, THE PLAN ENROLLMENT REALLY REFLECT THE DISEASE OR THE CONDITION THAT IS BEING STUDIED? OR THE OUTCOME THAT IS OF INTEREST? SO I THINK THAT IS ONE QUESTION AND ONE WAY TO THINK ABOUT JUSTICE. I WOULD ARGUE STATISTICAL ANALYSIS STANDPOINT, IT DEPENDS ON WHAT THE QUESTION IS. AND THERE ARE SOME TIMES WHERE WE DO WANT TO MAKE SURE THAT THERE IS AN ANALYSIS PLANNED BY SUBGROUPS. IF IT'S A DISEASE OR A CONDITION WHERE THERE IS A KNOWN DISPARITY BETWEEN POPULATIONS, THEN I DO THINK THAT WE SHOULD BE SAYING, WHERE IS THE ANALYSIS? KNOWN DIFFERENCE IN POPULATIONS, THEN WHY AREN'T WE ACTUALLY HAVING THE STUDY TO ASK AND ANSWER THAT QUESTION? >> WHICH IS TOTALLY FAIR. I MEAN, I THINK THE DIFFICULTY WHICH I HAD IN THE MULTIPLE -- I DON'T THINK THE COMMITTEE SEEN ALL SIX VERSIONS OF THIS. BUT IT'S REALLY TRYING TO PARSE OUT WHAT JUSTICE ADDS TO THE OTHER PRINCIPLES. AND I'M ACTUALLY GOING TO SCHEDULE THAT YOU JUST LET ME GO THROUGH THE DOCUMENT BECAUSE I THINK WE DO TALK TO SOME OF THESE THINGS. SO, I DON'T WANT TO GET CAUGHT UP IN THE BEGINNING WHEN THERE ARE THINGS THAT AT LEAST I TRIED TO ANSWER LATER ON. SO, LET ME JUST GO QUICKLY THROUGH IT. SO BURDENS AND BENEFITS. THEN I TALK ABOUT WHAT DOES THAT -- SO PARTICULARLY, WHAT ARE THE BURDENS, I THINK ARE RELATIVELY STRAIGHTFORWARD AND THOSE ARE THE THINGS WE ALWAYS TALK ABOUT, WHAT ARE THE BENEFITS. AND BASICALLY, YOU SHOULDN'T BURDEN POPULATIONS THAT DON'T HAVE THE POSSIBILITY OF HAVING -- AND YOU SHOULDN'T BURDEN POPULATIONS THAT ARE NOT AFFECTED BY THE DISEASES UNDER CONCERN OR UNDERSTUDY. SOMEONE ELSE COMMENTED ON THIS THAT WHAT ABOUT HEALTHY VOLUNTEER PHASE I RESEARCH? AND I THINK THAT IS SORT OF A SEPARATE WHERE OBVIOUSLY THE PEOPLE DON'T HAVE TO HAVE THE DISEASE -- BUT BASICALLY, PARTICIPATION SHOULD BE BASED -- OPPORTUNITIES SHOULD BE -- NEAR A POPULATION -- WHERE THERE ARE NO DIRECT -- AND THAT'S OBVIOUSLY TRUE IF THEY ARE THERAPEUTIC BENEFITS FOR PARTICIPATION IT'S PROBABLY ALSO TRUE, IT'S TRUE SCIENTIFICALLY AS WELL, IF YOU'RE LOOKING AT RESEARCH THAT HAS BURD EXPENSE IS NO DIRECT BENEFITS. PRESUMABLY THOSE INDIVIDUALS ARE REPRESENTATIVE OF A POPULATION THAT WILL HAVE THE OPPORTUNITY TO BENEFIT MORE BROADLY IN THE FUTURE. I DO THINK IT'S ALSO -- AND I WAS THINKING OF BRINGING THIS UP ITH THE PANEL. REMEMBERED, BUT THERE WASN'T TIME. WE ARE FOCUSED ON CLINICAL TRIALS. BUT THE REGS ARE ABOUT RESEARCH AND THE REGULATION OF RESEARCH. AND I THINK IT IS IMPORTANT TO CONSIDER SOCIAL BEHAVIOR AND RESEARCH, WHICH MAY IN FACT IN MANY WAYS THAT AFFECT THE SOCIAL DETERMINANTS OF HEALTH, INFORM POLICY AND PROCEDURES IN EDUCATION, IN LAW, SO THAT I DON'T THINK WHILE THERE IS -- I THINK WHAT REALLY SETS THAT APART IS THERE IS NO -- THE HARMS ARE DIFFERENT SO WE THINK OF IT DIFFERENTLY. THE BURDENS ARE DIFFERENT AND TYPICALLY LOWER AND NOT SO PHYSICAL. BUT THE BENEFITS ARE INEQUITABLE DISTRIBUTION OF THE BENEFITS CAN HAVE SIGNIFICANT IMPACT ON POPULATIONS. SO I DO THINK WE NEED TO MAKE SURE THAT WE ARE NOT ONLY THINKING ABOUT CLINICAL TRIALS. I TALKED ABOUT BELMONT AS HISTORICAL AS AN ANSWER TO A PROBLEM, WHICH WE TALKED ABOUT ON THE PANEL. THE PROBLEM OF EXPLOITATION AND THE INVOLVEMENT OF POPULATIONS OF CONVENIENCE INAPPROPRIATELY AND OFTEN AGAINST EITHER WITH -- IGNORANT OF WHAT THEY WERE DOING OR HAD NO POSSIBILITY OF SAYING, NO. AND WHAT IS NOW REALLY BEEN TURNED AROUND REALLY SINCE THE AIDS EPIDEMIC IS THE IDEA THAT RESEARCH IS SOMETHING MORE THAN THAT. IT'S THE ABILITY TO NOT ONLY BENEFIT PERSONALLY, BUT THAT THERE ARE ISSUES WITH INAPPROPRIATE EXCLUSIONS NOT JUST INAPPROPRIATE INCLUSIONS. AND THEN I TALK ABOUT RACE BECAUSE I HAVE TO SAY, AND I THINK WE ARE GUILTY OF THIS TOO, EVEN IN OUR CONVERSATIONS. WE TALK ABOUT RACE BUT WHAT WE SHOULD BE TALKING ABOUT IS THE SOCIAL DETERMINANTS OF HEALTH AND RACE STANDS IN FOR THAT. AND I THINK WHERE IT DOES STAND IN FOR THAT, WE NEED TO JUSTIFY THAT OR NOT USE -- IF WE ARE DOING THAT, WE SHOULD COLLECTED DATA ON THE SOCIAL DETERMINANTS OF HEALTH AND WE SHOULDN'T FALL INTO THE TRAP OF USING RACE AS A SURROGATE FOR THAT BECAUSE IT'S A CORRELATION, NOT A CAUSATION. AND IT ALSO HAS OTHER HARMS IN THAT IT REINFORCES -- >> STEVE, QUICK COMMENT. I LIKE WHAT OWEN HAD SAID IN TERMS OF WHAT RACE MEANS. RACE IS NOT JUST SOCIAL DETERMINANTS OF HEALTH. RACE IS ALSO POTENTIALLY MARKER FOR PHARMACOGENOMIC DIFFERENCES THAT MAY OR MAY NOT HAVE A MEANINGFUL IMPACT ON DRUG RESPONSE. [ MULTIPLE SPEAKERS ] >> I KNOW THAT IS TRUE. I THINK WE NEED TO JUSTIFY IT WHEN WE ARE USING IT FOR THAT. SO THAT'S THE ISSUE THAT I THINK CONSUELO RAISED ABOUT ANCESTRY VERSUS RACE. AND I THINK WE CONFLATE THOSE TWO THINGS ALL THE TIME. AND I THINK ONE OF THE LESSONS IS, IT'S NOT THAT THAT IS NOT RELEVANT. ANCESTRY AND GENOMICS ARE REALLY RELEVANT. BUT WE HAVE TO BE REALLY CAREFUL USING RACE TO MEAN THAT. >> I AGREE. IT'S A VERY POOR -- LET'S CALL IT A VERY POOR SURROGATE MARKER. BUT ALL I'M SAYING IS WE NEED TO UNPACK THAT. IF YOU WANT TO HAVE THIS TO BE TALKING ABOUT THAT, I THINK WE NEED TO UNPACK THOSE IDEAS. THAT'S ALL I'M SAYING. >> I CAN'T DISAGREE WITH THAT. I THINK THAT'S RIGHT. BUT I THINK THE ASSUMPTION IS BASED ON WE -- ANYWAY. I'LL JUST KEEP MOVING BECAUSE WE ARE ALREADY OUT OF TIME. SO HERE WE TALK ABOUT THE THINGS SKIP AND I TALKED ABOUT IN THE BEGINNING. SOME OF THIS IS COVERED UNDER OTHER PRINCIPLES. SO THESE WERE THE RECOMMENDATIONS, WHICH IN A WAY, ARGUABLY THE MOST IMPORTANT PART EVER THIS DOCUMENT, AND THIS IS THE FIRST QUESTIONED WAS, AMPLE DATA -- WHAT IS THE ROLE OF IRB ENSURING THAT RESEARCH CONDUCTED IN SETTING UP EQUITABLE HEALTH CARE DELIVERY APPROPRIATELY PROTECTS THE HEALTH AND WELFARE OF PARTICIPANTS. HOW CAN RESEARCH BE DONE SO IT DOESN'T IMPLICITLY INHERIT THOSE -- SO WE'VE NOT GOING TO HAVE TIME TO DO THIS. SO I'M STRUGGLING. I WOULD INVITE COMMENTS BUT I WANT TO BE SENSITIVE TO THE FA PHAKA AND THAT WE ARE ONLY SUPPOSED TO DISCUSS THIS STUFF IN THE COMMITTEE. SO JULIA, CAN IN INVITE BOARD MEMBERS TO SEND COMMENTS TO THE SUBCOMMITTEES THAT WE CAN THEN USE? OR DOES IT HAVE TO BE EXPRESSED HERE? >> SORRY. THIS IS JULIA. I THINK THAT'S REALLY GRAY. SO I WOULD RATHER NOT DOE THAT. I THINK ALL THE DISCUSSION WITH SACHRP NEEDS TO BE HERE IN THE PUBLIC DOMAIN AT SACHRP. >> OKAY. >> SO STEPHEN, ONE QUICK COMMENT AND I'M HAPPY TO HELP WITH THIS IF I WANT TO PUSH IT. THERE IS A LOT OF THOUGHT ABOUT HOW ONE EVALUATES THE SIMILARITY BETWEEN POPULATIONS AND THE DIFFERENCES BETWEEN POPULATIONS ASSUMING IT IS THE SAME POPULATION OR DIFFERENT POPULATION, HOW YOU DO THE SUBGROUP ANALYSIS, HOW DO YOU NOT? HOW DO YOU DRAW THOSE INFERENCES AND ALL YOU OF THAT COMES FROM THE LITERATURE ON PEDIATRIC EXTRAPOLATION. ADOLESCENTS IN ADULT TRIALS. IT'S THE SAME ISSUE AS INCLUDING A CERTAIN PROPORTION OF ASIAN ANCESTRY WITH CAUCASIAN AND EUROPEAN ANCESTRY. SAME QUESTION. SO THERE IS A LOT OF THINKING THAT CAN GO INTO HOW YOU MAKE ARGUMENTS FOR SIMILARITY AND DIFFERENCES IN POPULATION WHERE YOU JUSTIFY IT SCIENTIFICALLY. I AGREE WITH CONSUELO. IT HAS TO BE JUSTIFIED SCIENTIFICALLY. SO THERE IS A LOT OF THOUGHT THAT COULD BE BROUGHT TO BEAR ON THAT QUESTION. AND BOILED DOWN TO A FEW - I'M JUST CONCERNED TO BOIL IT DOWN TO SOME CONCRETE ADVICE TO GIVE TO IRBs ABOUT WHAT TO DOE. THAT'S ALL. >> SO LET ME GO THROUGH -- THIS IS THE CONCRETE ADVICE. SKIP, YOU'RE ON THE SUBCOMMITTEE SO WE CAN CONTINUE THIS CONVERSATION OFFLINE. I WILL SAY THAT I AM NOT SURE I AGREE THAT -- I MEAN, JUSTICE IS AN ETHICAL PRINCIPLE. WHY DOES IT HAVE TO BE -- THAT'S THE POINTED OF THE ETHICAL PRINCIPLES. IS THEY ARE ETHICAL PRINCIPLES. THERE IS SCIENCE YOU CAN AND CAN'T DO BECAUSE OF ETHICAL PRINCIPLES. I'M NOTED SURE IF WE IDENTIFY JUSTICE, IT DOESN'T HAVE -- >> ALL I'M SAYING IS I DON'T THINK YOU SATISFIED THE REQUIREMENTS OF JUSTICE. IT'S ALL YOU HAVE DONE IS GOTTEN A SORT OF POPULATION-BASED DISTRIBUTION. [ MULTIPLE SPEAKERS ] >> I AGREE WITH YOU. >> I AGREE WITH THAT AND WOULD ALSO ADD THAT IF -- WE HAVE TO CERTAINLY BE CAREFUL WITH, AGAIN, ESPECIALLY AS IT COMES DOWN TO RACE AND ETHNICITY, NOT CONTINUING TO CENTER WHITENESS. SO, WITH THESE ANALYSIS THAT WE ARE DOING AND PLANNING AND TALKING ABOUT, IF WE ARE STILL COMPARING OR CONSIDER NORMS TO BE WHITE PEOPLE, AND NOT REALLY THINKING ABOUT THE HARMS THAT WE'RE GOING TO CREATE JUST BY HAVING MORE DIVERSE PEOPLE IN, BUT THEN STILL DOING BAD SCIENCE OR STILL DOING THE ANALYSIS INCORRECTLY, THEN WE ARE ACTUALLY CREATING INJUSTICES. AND SO WE ARE REALLY WANTING TO PROMOTE JUSTICE, THEN WHAT IS THE END JUSTICE WE ARE PREVENTING OR CORRECTING? SO THE RECOMMENDATIONS NEED TO BE AROUND THOSE THINGS. >> RIGHT. >> BARBARA? >> I'M SORRY, JUST INTERRUPTING HERE KNOWING YOU'RE PRESSED FOR TIME ON THE AGENDA. JUST BE AWARE THAT WE HAVE NO PUBLIC -- [ INAUDIBLE ] >> I HAVE SOME THINGS TO READ OUT BUT THEY SHOULDN'T TAKE LONG. >> SO THAT THEORETICALLY BUYS YOU BACK 15 MINUTES. >> AND BARBARA, I THINK YOU WERE -- I'M TRYING TO -- I HAVE THIS LITTLE REDUCED SPACE HERE. SO I DON'T KNOW IF I SEE EVERYBODY. >> SO I WAS JUST GOING TO SAY, AND I WAS JUST TYPING IT INTO THE CHAT, THAT IT REALLY DEPENDS ON THE OUTCOME THAT YOU'RE WISHING TO ASSESS AND HOW ONE THINKS ABOUT JUSTICE IN THAT WAY. THE POINT OF INCLUSION IS MULTIDIMENSIONAL, SKIP, AND ONE HETEROGENEITY OF TREATMENT EFFECT ACTUALLY THE FDA AND MRCT ARE LEADING A -- OR COORDINATING A CONFERENCE EXACTLY ON THIS POINT, NOVEMBER 30 AND DECEMBER 1, TO WHICH EVERYBODY IS INVITED. BUT I DO THINK THAT THERE ARE TOOLS NOW IN PHASING ANALYSIS, NOT EVERYTHING IS AROUND WITHIN A SINGLE GIVEN TRIAL, AND IT IS REALLY OVER THE PROGRAM INCLUSIVE OF REAL WORLD DATA AND SORT OF THE DEFINITION OF THE DATA ELEMENTS AS CONSUELO WAS MENTIONING, AND THAT WE NEED TO LOOK AT THIS MORE HOLISTICALLY, BUT THAT IS NOT TO UNDERMINE ANY OF THESE INDIVIDUAL GOALS OF INCLUSION. I DON'T THINK THAT IT'S OBVIOUS HOW TO DO THAT, BUT I THINK IT'S FUNDAMENTAL TO THE QUESTIONS YOU'RE ASKING. THE QUESTION OF HOW DOES THE IRB REVIEW A SINGLE JOURNAL, WHICH IS WHAT YOU'RE GETTING AT, IS COMPLICATED. AND WE CAN TAKE IT OFF LINE, BUT -- >> THAT'S GREAT. I AGREE. I PURPOSE LIE AVOIDED USING THE WORD, BAYESIAN IN MY COMMENTS. >> I KNOW YOU DID. [ MULTIPLE SPEAKERS ] >> I SAID THAT JUSTICE HAS TO STAND SEPARATE OR APART FROM SCIENCE. THERE IS NO EXCUSE TO USE JUSTICE AS AN END IN ITSELF EITHER. YOU DON'T WANT TO DO BAD SCIENCE IN THE NAME OF EQUITY. THAT MAKES NO SENSE AT ALL WHEN WE ARE TALKING ABOUT RESEARCH. ALL I'M TALKING ABOUT IS THE ULTIMATE JUSTIFICATION. I'M GOING TO RUN THROUGH THESE FEW THINGS FOR THE IRB BECAUSE I THINK -- SO THE FIRST ONE, AND THESE MIRROR MANY OF THE THINGS BARBARA RAISED. INDIVIDUAL STUDY DESIGN BURDEN AND PLACES ON INDIVIDUAL PARTICIPANTS, SO WHERE THERE ARE DIFFERENTIAL BURDENS. THAT BE EXPLICITLY ADDRESSED OR JUSTIFIED. COMPENSATION, WE HAD A WHOLE SACHRP PRODUCT ON THAT WHICH I THINK HAS TO BE LOOKED AT THROUGH THE LENSE OF THE IMPACT ON, IN PARTICULAR THE SOCIAL DETERMINANTS OF HEALTH. COMP AND INJURY WE DON'T TALK ABOUT THAT MUCH BUT WE SAY BASICALLY PEOPLE HAVE A RIGHT TO SUE IN MANY CASES. THAT'S NOT SOMETHING THAT FALLS EQUALLY -- NOT AN OPPORTUNITY THAT FALLS EQUALLY AT ALL. AND I JUST PUT THIS IN AS A PROFESSOR NORM, IRB PROFESSORS ADVOCATE FOR IRB SECTION. ADDITIONAL SAFEGUARDS. I'M JUST GOING TO GO THROUGH THESE AND THEN WE CAN TALK ABOUT THEM. THIS IS KIND OF USESES THE RESEARCH LANGUAGE 46111B. WHICH WE NOTED IN THE CHARGE IS SEPARATE FROM THE APPROVAL CRITERIA UNDER 111A. ARE IN FLIES PROTECT RESEARCH SUBJECTS -- [ READING ] SO WHAT DOES THAT MEAN? AND I TALKED THEN ABOUT THE EXPLOITATION AND HOW WE HAVE TO THINK ABOUT INCLUSION. SO THIS IS THIS CONCLUSION TIME TO CONSIDER WHETHER RESEARCH HAS AN OBLIGATION TO ACTIVELY PROMOTE. AND THIS IS -- AND I SUSPECT NOT EVERYBODY WILL AGREE, THAT THE RESEARCH ENTERPRISE AS A WHOLE MUST BE RECOGNIZED AS A SOCIAL PROJECT AND [ READING ] AS A SOCIAL PROJECT, RESEARCH MUST BE EQUALLY OPEN TO ALL MEMBERS OF SOCIETY. THAT IS WHAT BEING A MEMBER OF SOCIETY IS SUPPOSED TO BE. SO, INDIVIDUAL IRBs CANNOT CHANGE THE CURRENT HEALTH CARE DELIVERY SYSTEM. BUT INSTITUTIONS CONDUCTING RESEARCH -- SOMEBODY SAID WE TURN PEOPLE AWAY AND THEN WE SAY WE NEED YOU -- TURN THEM AWAY FOR CARE AND THEN WE SAY WE NEED YOU TO DO THIS RESEARCH STUDY. INSTITUTIONS DO HAVE SOME ROLE TO PLAY HERE IN DOING WHAT THEY CAN TO MAKE SURE ACCESS IS. AND THAT DOES HAVE IMPLICATIONS FOR THE RESEARCH ENTERPRISE. SACHRP RECOGNIZES ONE OF THE LIMITATIONS IN PROMOTING INCLUSION SILENT SCOPE OF INDIVIDUAL IRB REVIEW. IT'S RELATIVELY EASY TO ENSURE INDIVIDUAL EXCLUSIONS MORE DIFFICULT FOR AN IRB TO ENSURE JUST OPPORTUNITIES FOR PARTICIPATION. AND MUCH OF THIS -- ENTITIES UPSTREAM OF THE IRB. SO THIS IS AGAIN, IN PARALLEL, THIS IS WHAT MRCTD. SACHRP RECOMMENDS -- [ READING ] SO THIS IS THE ISSUE OF REPRESENTATION ON THE IRB, WHICH IS SORT OF A DIFFICULT THING. SO, YOU CAN'T PUT -- SO THERE ARE TWO ISSUES. ONE IS, YOU CAN'T REPRESENT EVERYBODY. AND CHANGE FOR RESEARCH STUDIES. AND THE OTHER THING, IS EVEN IN MY EXPERIENCE, EVEN IF YOU PUT PEOPLE ON THE IRB WHO ARE SUPPOSED TO BE REPRESENTATIVE, THE WAY THE IRB IS RUN MAKES A HUGE DIFFERENCE AS TO WHETHER THOSE PEOPLE HAVE A VOICE OR NOT. I MEAN, PARTICULARLY IN BIOMEDICAL RESEARCH, IT'S NOT UNCOMMON FOR THE NON SCIENTIFIC MEMBERS OF THE IRB NOT TO BE ENCOURAGED AND NOT TO TALK A LOT. SO I THINK THAT IS -- THIS IS A PERSONAL THING THAT BASICALLY WE SPEND SOME TIME CONSIDERING WHAT YOU SHOULD DO TO RUN A GOOD IRB AND HEAR FROM THE PEOPLE YOU'RE SUPPOSED TO BE REPRESENTING. AND THEN, BARBARA, TO YOUR POINT. SOME OF THIS REALLY HAS TO BE CONSIDERED DIFFERENTLY IN THE SINGLE IRB STATE. AND ONE OF THE THINGS ABOUT SINGLE IRBs OR STUDIES DONE UNDER THE SINGLE IRB MANDATE IS THE JUSTIFICATION WORK FOR THAT WAS LOWER BURDEN, LOWER COST. SOME OF THAT MAYBE SHOULD BE PUT IN THAT SETTING TO ENHANCE REVIEW OF THIS KIND OF ISSUE IN A SINGLE IRB WORLD, WHICH TENDS TO BE MULTISITE CLINICAL TRIALS. SO, IT ALLIANCE WITH WHAT WE ARE TALKING ABOUT. THIS IS THE BUSINESS ABOUT RUNNING THE IRB MEETINGS. THE ADVISORY BOARDS, WHICH I'M SENSITIVE TO WHAT WE TALKED ABOUT EARLIER, BUT BASICALLY AS FAR AS GOING BEYOND THAT, WHAT OWEN SAID ABOUT THAT NOT BEING ENOUGH. BUT BASICALLY FORMAL RULE AND THE EVALUATION OF INDIVIDUAL RESEARCH STUDIES AND INSTITUTIONS RESEARCH PORTFOLIO. AND THEN THERE IS A BROAD QUESTION ABOUT ADDITIONAL THINGS WE COULD DO, GUIDANCE AND TRAINING AND RESOURCES. I THINK THAT WE HAVE A SENSE OF THIS BUT IT HADN'T BEEN THE TOPIC OF A LOT OF OR ENOUGH, I SHOULD SAY, PRIMARY RESEARCH. WE KNOW SOME THINGS ABOUT HEALTH DISPARITIES. WE KNOW SOME THINGS ABOUT INEQUITABLE DISTRIBUTION OF HEALTH OUTCOMES. WE DON'T NECESSARILY -- WE DON'T HAVE A LOT OF INTERVENTIONAL RESEARCH FOCUSED ON WHAT WE DO ABOUT THAT. AND THAT'S DIFFERENT THAN DEVELOPING A NEW DRUG THAT WORKS BETTER THAN ANOTHER F THERE IS A SOCIAL DETERMINANTS OF HEALTH, IT'S NOT CLEAR THAT CLINICAL TRIALS AND DRUG DEVELOPMENT ARE THE RIGHT PATHWAY. AND SOME OF THE THINGS -- IT'S JUST AN OBSERVATION, WHICH OBVIOUSLY THE COMMITTEE WOULD HAVE TO ENDORSE IF WE WANT TO LEAVE IT IN HERE. BUT, IT STRIKES ME THAT WITHIN HEALTH CARE RESEARCH, EFFECTIVE INTERVENTIONS TO ADDRESS THE SOCIAL DETERMINANTS OF HEALTH ACTUALLY HAVE THE POTENTIAL TO MUCH MORE BROADLY IMPACT THE HEALTH OF AMERICA THAN ANY PARTICULAR DRUG DEVELOPMENT. SO THAT'S JUST AN ENDING. SO THAT'S IT. SO LET ME ASK BEFORE WE GO, IT'S 3:30. IF WE SPEND VERY LITTLE, IF ANY TIME, ON PUBLIC COMMENT, DO WE HAVE -- WE HAVE 30 MORE MINUTES. WE DID PUT OFF SEVERAL SUBJECTS. WE'LL HAVE TO COME BACK TO THAT ANYWAY. SO IF DAVID IS AGREEABLE, WE CAN LEAVE THAT UNTIL NEXT TIME AND CONTINUE THIS CONVERSATION, OR WE CAN DO ANOTHER 15 MINUTES OF THAT AND TURN TO THAT TOPIC. I ACTUALLY DON'T THINK IT'S WORTH TURNING BACK TO THAT TOPIC. DAVID, WHAT DO YOU THINK? >> I HAVE PLENTY TO WORK ON WITH THAT JUST FROM THE FIRST HALF OF THE DOCUMENT. >> THANK YOU. SO LET'S CONTINUE ON THIS ONE, THEN. AND I APOLOGIZE FOR RUSHING THROUGH THIS. THIS IS NOT THE WAY I WOULD HAVE WANTED TO DO IT, BUT, THAT'S HOW OUR TIME WORKED OUT. WE SHOULD HAVE JUST HAD TOMORROW DEVOTED ONLY TO JUSTICE. SO, I CAN'T SEE PEOPLE WHO RAISE THEIR HAND OR WANT TO TALK BECAUSE I'M PRESENTING. SO JUST SPEAK. CONSUELO I SEE YOU POPPED UP. >> YES, AND I DID PUT SOMETHING IN THE CHAT BOX ABOUT DEFINING RACE. I THINK I WOULD ENCOURAGE THAT BEING A SPECIFIC RECOMMENDATION, THAT THERE IS AN EXPECTATION THAT RACE IS DEFINED, HOW IT'S BEING USED, WHAT THE PURPOSE OF IT IS, WHETHER OR NOT IT'S A PROXY FOR SOMETHING ELSE. I WOULD LOVE TO HAVE A STANCE ON INCLUSION OF SOCIAL FACTORS BUT I THINK THAT MIGHT BE CHALLENGING FOR SOME SPECIFIC STUDIES. BUT OF COURSE WE KNOW RACE AND ETHNICITY ARE OFTEN BEING USED AS PROXIES SO IT WILL BE HELPFUL FOR THAT TO BE SPECIFICALLY CLARIFIED. I AM A LITTLE BIT CONCERNED STILL ABOUT THE USE OF -- THE INCLUSION OF SOCIAL, IN THE DOCUMENT. RESEARCH AS A SOCIAL PROJECT. I DON'T KNOW THAT THAT ADDS MUCH TO WHAT WE ARE TRYING TO SAY. IT COULD BE A DISTRACTION. I THINK -- I CERTAINLY AGREE WITH THE PRINCIPLES UNDERLYING THAT, THAT IT SHOULD BE OPEN AS MUCH OF THE RESEARCH WE ARE TALKING ABOUT IS PUBLICLY-FUNDED. IF WE ARE REALLY DOING GOOD SCIENCE AND DISCOVERY, WE ARE INCLUDING THE POPULATIONS WHO HAVE CONDITIONS OR ARE AT RISK AND SO I THINK ALL OF THOSE THINGS SPEAK TO WHAT YOU MEAN. I JUST -- I'M CONCERNED THAT INCLUDING LANGUAGE LIKE SOCIAL, WILL BE -- SOCIAL PROJECTS WILL BE A DISTRACTION. I THINK ASKING PEOPLE TO BE -- HAVE A PROFESSIONAL NORM, A FOCUS ON EQUITY AND JUSTICE, FLUMES THERE WILL BE SOME TRAINING AND PREPARATION FOR THAT. SO IZ WONDER IF WE WANT TO CONSIDER WHAT THAT WOULD LOOK LIKE, WHO WOULD CREATE IT AND HOW THAT NORM WOULD BE ESTABLISHED. AND THEN THE FINAL PIECE IS, IF WE ARE ENCOURAGING HHS TO SUPPORT RESEARCH IN THIS SPACE, THEN PERHAPS A DIFFERENT FOCUS WOULD BE THAT IT'S FUNDED. SO THERE IS AMONG THE HEALTH DISPARITIES ONE OF THE LEAST FUNDED INSTITUTES AT NIH. IT IS SINGULARLY SOMETIMES RESPONSIBLE FOR DOING A LOT OF THE WORK IN THIS SPACE, ALTHOUGH CERTAINLY, THE LARGER INSTITUTES DO HAVE NHLBI AND N-IDDK HAVE PROGRAMS THERE. WHAT SPECIFICALLY ARE WE ASKING TO BE DONE DIFFERENTLY? I THINK THAT WOULD NEED A LITTLE MORE CLARIFICATION. >> I'M SORRY, THIS IS JULIA. I'M JUST GOING TO JUMP IN HERE AND ASK MEMBERS AND PANELISTS TO NOT USE THE CHAT FEATURE FOR REFERENCES AND SUBSTANTIVE DISCUSSION, PLEASE. IT'S A PROBLEM FOR THE NOTETAKER AND THE PUBLIC ACCESS. THANK YOU. >> THANK YOU, CONSUELO. THOSE ARE ALL -- I HAVE MIXED FEELINGS ABOUT THE SOCIAL PROJECT ISSUE BECAUSE IT GETS TO WHAT I WAS TALKING ABOUT EARLIER, WHEN I LOOKED AT THE COVID TRIALS. THEY WERE ALL DONE BECAUSE PEOPLE WANTED TO DO RESEARCH. THEY WEREN'T DONE -- ASSEMBLING PEASES OF A PUZZLE WITH GREATER KNOWLEDGE. AND I ALSO LOOKED AT RESEARCH AND IRBs AS A TRAGEDY OF THE COMMONS PROBLEM. SO THAT SOME OF THIS REFLECTS MY THINKING THAT WE NEED TO MOVE, PARTICULARLY WITH RESEARCH INVOLVING OTHER PEOPLE, WE NEED MOVE BEYOND THIS IDEA OF COMPLETE ACADEMIC FREEDOM, AS LONG AS YOU DON'T HURT, THAT IN PUBLICLY-FUNDED RESEARCH OR IN RESEARCH, THAT IS PART OF A BIGGER PROJECT, RESEARCHERS HAVE AN OBLIGATION TO SERVE THAT PROJECT AS OPPOSED TO JUST ANSWERING THE QUESTIONS THAT THEY ARE INTERESTED IN. BUT I'M NOT SURE IT BELONGS IN THIS DOCUMENT. SO THERE. >> STEPHEN, THIS IS LESLIE. [ FEEDBACK ] WHAT I WANTED TO SOARED OF START WITH IS WHERE I SAID IN TERMS OF MY APPRECIATION FOR THE PANEL EFFORTS. AND I DO THINK THAT WE CAN JUST COME STRONGER AND PERHAPS IT'S -- AS CONSUELO MENTIONED, THAT COMMENTED ABOUTY PROFESSOR NORM. I WANTED TO MOVE IT UP BUT LISTENING TO HER COMMENT, WHAT IT IS JUST MAKING A STRONGER ARGUMENT, A STRONGER EMBRACE OF, THIS IS A QUESTION THAT IS WELL WITHIN THE IRB PER VIEW AND THAT WHY SHOULD BE POSING THE QUESTIONS WHETHER IT'S IN THE WAY THAT WAS PUT OUT THAT BARBARA AND HER GROUP PUT IT OUT, BUT AS CONSUELO ASKED, WHY ARE YOU ASKING FOR THIS INFORMATION? WHAT DO YOU REALLY WANT TO DO WITH IT AS WELL AS, WHY ARE YOU RECRUITING AT THE ACADEMIC MEDICAL CENTER IF THAT'S NOT THE POPULATION? JUST ASKING QUESTIONS ABOUT SPECIFIC COMPONENTS THAT ARE WELL WITHIN THE IRB WHILE ALSO SIMULTANEOUSLY RECOGNIZING THAT THE IRB ALONE IS NOT GOING TOW RESOLVE THIS ISSUE T ABSOLUTELY WILL REQUIRE FUNDERS TO ALSO TAKE THIS ISSUE SERIOUSLY AND ENFORCE THEIR OWN POLICIES IN THIS REGARD THAT CONVEILO HAS ALREADY MENTIONED IN TERMS OF HOW DIFFERENT STUDIES ARE EVALUATED, FOR EXAMPLE, AT NIH. BUT WE CAN LEND OUR VOICE THAT AS ETHICS AND SCIENCE DEMANDS THIS. WHEN YOU ARE GIVING A SPECIFIC EXAMPLE, I DO THINK, AGAIN, INDIVIDUAL STUDY DESIGN AND BURDENS, THAT'S WHERE WE CAN ADD SOME OF THOSE KINDS OF QUESTIONS THAT PEOPLE OUGHT TO BE THINKING ABOUT. I THINK WE CAN CONNECT IT VERY STRONGLY, THE COMPENSATION COMPONENT TO THE WORK, AS YOU INDICATED, THAT WE HAVE ALREADY PUT OUT AND BE VERY EXPLICIT THAT IF -- AND THAT THE ECONOMIC DISPARITIES THATANIST OUR COUNTRY MAY REALLY MAKE IT -- THAT EXIST IN OUR COUNTRY -- SO THAT OTHERS CAN'T IF YOU'RE NOT PAYING ATTENTION TO THIS ISSUE BECAUSE THEY JUST WON'T BE ABLE TO PARTICIPATE. AND THEN, WITH RESPECT TO THE COMPONENT ABOUT THE MAKEUP OF THE IRB. THERE IS SOME CHALLENGE THAT IS YOU IDENTIFY, INCLUDING THE UNDER REPRESENTATION OF PEOPLE -- OF COLOR IN MDs, PH.D.s, JDs, ET CETERA, WHICH MEANS THEY ARE ALREADY OVERWHELMED WITH SERVICE OBLIGATIONS, BUT THERE ARE ALSO OTHER WAYS TO AUGMENT THAT AND I MENTIONED AT THE LAST MEETING, THE DEPARTMENT OF DEFENSE IN THEIR CONGRESSIONALLY-DIRECTED MEDICAL RESEARCH PROGRAM DOES AN EXCELLENT JOB OF REALLY HIGHLIGHTING THE VOICES OF COMMUNITY MEMBERS, WHICH ARE REQUIRED ON EACH OF THEIR PANELS, THEIR PLACE SO THEY GIVE THE SECOND PIECE. AND MY OWN VIEW OF IT, THEY ACTUALLY BROUGHT IN THE PARTS OF THIS WOULD BE REALLY BAD RESEARCH BECAUSE IT SOUNDS REALLY GOOD ON PAPER BUT IT WON'T ACTUALLY WORK. AND THE OTHER PIECE IN TERMS OF -- YOU HAD A COMMENTED ABOUT MANAGEABLE SIZE. OFTEN REALLY LARGE BECAUSE PEOPLE ARE BUSY AND THEY DON'T SHOW UP. AND WE STILL DON'T HAVE AS MUCH REPRESENTATION AS WE SHOULD. SO, WE MAY WANT TO BE WILLING TO COMPROMISE ON THAT IN ORDER TO GET BACK TO SORT OF WHAT WAS ORIGINALLY CONTEMPLATED WITH THE 1-5 REQUIREMENTS WHEN VERY FEW IRBs ACTUALLY ONLY HAVE FIVE MEMBERS. THERE WAS AN ARTICLE ABOUT THAT PROBABLY A DECADE AND A HALF AGO. AND I THINK THERE ARE STRUCTURAL ISSUES FROM TERMS OF ENSURING VOICES, INCLUDING HOW COMMENTS ARE SOLICITED, HOW MEMBERS RESPOND TO THOSE COMMENTS AND HOW MUCH REPRESENTATION THERE IS. >> SO, ONE OF THE CHARACTERISTICS OF THIS DOCUMENT, WHICH IS JUST BECAUSE IT HAS TO -- I MEAN THE RECOMMENDATIONS ARE RELATIVELY GENERAL BECAUSE IT'S NOT CLEAR. SO YOU KNOW, IN TERMS OF THIS BEING UNDER THE PER VIEW OF THE IRB, I ASSUME THAT IS 111A3. EQUITABLE SELECTION, WHICH IS LIKE ONE SENTENCE. AND THEN IT GOES ON TO QUALIFY THIS IS AING, BUT PAY PARTICLAR ATTENTION TO COERCION AND UNDUE INFLUENCE. THAT'S WHERE WE ALWAYS SPENT OUR TIME. SO, PART OF THIS IS REALLY HOW AN IRB SHOULD INTERPRET WHAT THAT SENTENCE MEANS. WITHOUT ANY -- AGAIN, WE ARE GIVEN GUIDANCE ON WHAT IT MEANS WHEN IT -- WHEN WE ARE TRYING TO AVOID INCLUSION OF INAPPROPRIATE POPULATIONS OF CONVENIENCE. BUT BEYOND THAT, THE REGULATIONS DON'T SAY ANYTHING. SO, THANK GOODNESS THERE IS THAT SENTENCE THERE OR WE WOULD BE REALLY STUCK BECAUSE IT'S A PRINCIPLE AND YET WE WOULDN'T HAVE -- I MEAN THERE ARE INCREASING NUMBER OF IRBs THAT ARE COMMON RULE LITERALISTS, IF YOU WILL. AND SO IF IT'S NOT THE LANGUAGE THAT ISN'T THERE, THEY ARE NOT GOING TO DO IT. SO I THINK A LOT OF THIS GOES TO EXPLICATING EXACTLY WHAT WE MEAN BY THAT AND I THINK WE NEED TO HAVE A COMMON UNDERSTANDING. I THINK THAT'S THE CHALLENGE BEHIND ALL OF THIS AS FAR AS IT APPLIES TO THE IRB. THE OTHER THING THAT STRIKES ME IS JUST ONE MORE REMARK. AND THE IRBs THAT HAVE REPRESENTATION ON SACHRP ARE REALLY UNUSUAL IRBs. I MEAN, I DON'T KNOW HOW MANY ARE REGISTERED. 2000 IN THE UNITED STATES. MOST OF THEM ARE RELATIVELY SMALL DUE TO A LOT OF SOCIAL BEHAVIORAL WORK. MOSTLY EXPEDITED. THERE ARE NOT A LOT OF CLINICAL TRIALS. SO WHEN WE TALK ABOUT WHAT THE IRB SHOULD DO, I JUST THINK WE HAVE TO KEEP IN MIND THAT IT'S NOT JUST THE STANFORDS AND YALES AND HARVARDS THAT ARE PART OF OUR AUDIENCE. A LOT OF THIS STUFF GOES ON -- NOT ALL BIG CLINICAL TRIALS. IT'S A LOT OF LITTLE STUFF, SINGLE-INSTITUTIONS, SOMETIMES LOW-RISK. BUT FOR WHICH JUSTICE, YOU HAVE TO START THERE TOO. SO, I JUST WANT TO MAKE SURE THAT WE PRESERVE THAT. LET'S SEE IF EVERYBODY AGREES. >> [ INDISCERNIBLE ] >> I WAS GOING TO JUST MAKE A COUPLE OF POINTS. I HAVE BEEN LIFT EARNING TO THE DISCUSSIONS WITH GREAT INTEREST. AND I THINK SO ONE OF THE POINTS AND CONSUELO ARTICULATED IT WELL. YOU REALLY HAVE TO START WITH THE SCIENCE. IS THERE A REASON TO BELIEVE THAT THERE ARE GOING TO BE DIFFERENCES IN OUTCOME AS A RESULT OF THE EXPOSURE, BE IT A THERAPEUTIC, OR BEHAVIORAL INTERVENTION, ON THE BASIS OF PARTICULAR GROUPS, HOWEVER WE DEFINE THEM. THAT'S LIKE POINT 1. THE SECOND PIECE IS -- AND THIS WAS A DIALOGUE SOMETIME AGO BETWEEN STEPHEN AND SKIP, WHICH HAD TO DO WITH THE CONCERNS ABOUT SUBANALYSIS THAT ARE UNDERPOWERED AND NOT REALLY JUSTIFIED. AND I DO SHARE SKIP'S CONCERN THAT THAT IS A POSSIBILITY. THAT IF ONE HAS PROTOCOLS THAT PRE DEFINE SUBPOPULATIONS, THERE IS GOING TO BE A TEMPTATION BY THE -- EITHER THE RESEARCHERS OR BY SOME GROUPS SUBSEQUENTLY, TO CONDUCT SUBANALYSIS ON THOSE POPULATIONS. WHEN IN FACT, THE DRIVER MAY BE VERY MUCH WHAT STEPHEN WAS ARTICULATING EARLIER ON. THAT THIS IS REALLY -- THAT THERE IS A FUNDAMENTALLY ETHICAL FOUNDATION FOR SOME OF THIS INITIATIVE DRIVEN BY DISTRIBUTED INTEREST IN DISTRIBUTIVE JUSTICE AND IN MA LIVE SENSE. IT SEEMS TO ME IF WE WERE TO MAKE THAT A BIT CLEARER IN THE PREAMBLE IN THE DOCUMENT, THAT MIGHT BE VERY HELPFUL IN TERMS OF HOW IT IS INTERPRETED AND IMPLEMENTED. I COULD READILY SEE THAT IF THE PROTOCOLS -- THEY COULD HAVE A STATEMENT WHICH IS DRAWN FROM THIS DOCUMENT AROUND THE INTENT OF INCLUSION OF VARIOUS DIFFERENT POPULATIONS, AND I THINK THAT MIGHT BE VERY HELPFUL. I AM CERTAINLY SENSITIVE TO THE POINT THAT STEPHEN MADE THAT, MANY IRBs ARE VERY PRESCRIPTIVE AND THEY DON'T HAVE THE RESOURCES THAT ARE AVAILABLE AT THE MAJOR INSTITUTIONS THAT ARE REPRESENTED WITHIN SACHRP. SO, THANK YOU. >> LINDA, JUST A SECOND BEFORE I GET TO YOU. I WANT TO JUST POSE A QUESTION THAT MAYBE WE FEEL DIFFERENTLY ABOUT IT. AND THAT IS F WE KNEW THERE WAS A HEALTH CONDITION, THAT WE KNEW HAD NO DIFFERENCES ACROSS POPULATIONS, I DON'T KNOW HOW. THIS IS A HYPOTHETICAL. WE KNEW IT. WOULD THAT JUSTIFY -- SO THERE IS NO ISSUE OF SUBGROUP ANALYSIS, NO ISSUE OF SCIENCE. IS IT OKAY UNDER THOSE CIRCUMSTANCES TO USE A BUNCH OF WELL OFF WHITE PEOPLE WHO HAPPEN TO BE THE PEOPLE WHO COME TO YOUR INSTITUTION FOR YOUR RESEARCH? OR DOES THAT RAISE OTHER ISSUES THAT ARE NOT SCIENTIFIC? WE KNOW THEY ARE NOT SCIENTIFIC. >> I THINK IF I COULD JUST QUICKLY RESPOND TO THAT. I THINK THAT IS, NO. I THINK OWEN MADE A VERY GOOD CASE. THAT PART OF THE BENEFIT OF DRAWING DIVERSE AND INCLUSIVE POPULATIONS IS REALLY TO PROVIDE THE KIND OF, IF YOU WILL, KIND OF VALIDITY AROUND THE SCIENCE AND IT BECOMES PERSUASIVE TO A POPULATION THAT THE DATA ARE RELEVANT BECAUSE THEY ARE DRAWN -- SOME OF THE INDIVIDUALS ARE DRAWN FROM THAT POPULATION. I THINK THERE IS A REAL CASE TO BE MADE FOR THAT. >> SO THAT'S A UTILITY ARGUMENT. IT DOESN'T GO TO A PRINCIPLED ARGUMENT. I GUESS THAT'S WHAT I'M TRYING TO GETTA. IS THERE A PRINCIPLED -- [ MULTIPLE SPEAKERS ] >> FROM A SCIENTIFIC STANDPOINT, THERE IS NO JUSTIFICATION FOR DOING A STUDY THAT INCLUDES PEOPLE FROM THE SPECIFIC POPULATION SOCIODEMOGRAPHIC, SOCIOECONOMIC DEMOGRAPHIC WHEN THEY DON'T REFLECT THE DISEASED DISTRIBUTION. [ MULTIPLE SPEAKERS ] EVEN IF YOU SAY THERE IS NO DIFFERENCE IN GROUPS, YOU'RE STILL NOT LOOKING AT -- THAT'S AVERAGE. THAT'S AVERAGE ACROSS GROUPS. THAT'S NOT PEOPLE IN A CERTAIN ZIP CODE. THAT'S THE SAME THING WE LEARNED ABOUT PHYSICIANS. THE PHYSICIANS STUDY, CAN WE EXTRAPOLATE EVERYTHING WE LEARNED ABOUT PHYSICIANS TO ALL OTHER PEOPLE? >> SO CONSUELO, I GET THAT PRACTICALLY. SO IT'S PURELY A THOUGHT EXPERIMENT. BUT I'M TRYING TO GET TO THE POINT THAT YOU TAKE THE SCIENTIFIC ISSUES AWAY. TAKE THE NEED FOR FACE VALIDITY, A UTILITY ISSUE, AWAY. IS THERE AN IMPERATIVE THAT IS JUST JUSTICE? I MEAN, WE ARE TALKING ABOUT THE BELMONT PRINCIPLES. WE DON'T BOTHER JUSTIFYING MAGNIFICENCE BEYOND MINIMIZING HARMS. WE FEEL LIKE WE HAVE TO TALK ABOUT, WHY ARE WE MINIMIZING? I'M GOING TO COME BACK TO YOU. MAYBE THERE ISN'T, THAT'S WHERE I WAS COMING FROM. I'M SORRY, LINDA, GO AHEAD. >> I WAS GOING TO SAY, I DON'T WANT TO CHANGE THE DIRECTION OF THE CONVERSATION SO MAYBE YOU CAN FINISH THIS AND I'LL JUST JUMP IN, IN A BIT. WHAT I WANT TO TALK ABOUT IS A LITTLE MORE ABOUT THE RESEARCH PROCESS AND HOW THE IRB FITS IN AND I THINK THIS IS -- SO HOWEVER YOU WANT TO DO THAT. I'M HAPPY TO WAIT. >> WE ACTUALLY HAVE A PRACTICAL AND IMPACTFUL COMMENT? >> I DON'T KNOW IF IT'S PRACTICAL OR IMPACTFUL. I'M JUST GOING TO MAKE A COMMENT. I THINK THAT IT'S KIND OF RELATED TO A COMMENT THAT WAS MADE EARLIER ABOUT HOW THE REPRESENTATION OF THE IRB AND HOW YOU ENGAGE PEOPLE TO ASSIST THE IRB LIKE USING A CONSULTANT TO HELP THE IRB. BUT ALSO WE FOCUS, I THINK, A LOT WHEN WE THINK ABOUT RESEARCH IN A VERY LINEAR WAY. EVERYTHING IS VERY SEQUENTIAL. YOU START THE FEASIBILITY, THE IRS TOWARDS THE LAST -- IRB -- AT THE END WHEN WE HAVE ALREADY KIND OF LOOKED AT THE SCIENTIFIC RESEARCH, THE SCIENTIFIC VALIDITY AND LOOKED AT THE RESEARCH ITSELF. I MEAN, I THINK THAT IT'S WORTH EXPLORING A SUGGESTION THAT THE IRB AND COMMUNITY, ET CETERA, BE ENGAGED EARLIER AND FEASIBILITY AND CONCEPT WHEN YOU'RE THINKING ABOUT THE CONCEPT OF THE STUDY AS WELL. IT CERTAINLY, WHEN YOU'RE DEALING WITH A CLINICAL TRIAL AND INDUSTRY-SPONSORED TRIAL IS DIFFERENT IN TERMS OF YOUR ABILITY TO INFLUENCE THAT. BUT CERTAINLY WE DO A LOT OF PI INITIATED RESEARCH AND THERE IS AN OPPORTUNITY TO ENGAGE THE IRB EARLIER ON TO START TALKING ABOUT ALL OF THE BELMONT PRINCIPLES WHEN WE ARE LOOKING AT THE RESEARCH. AND THEN, THAT WAY, AS IT MOVES THROUGH THE PROCESS, AND GETS MORE REFINED, THEN IT GETS TO THE IRB, IT'S NOT TO SAY THAT YOU WON'T LOOK AT THAT AGAIN TO VERIFY THE RECRUITMENT STRATEGIES AND SOME OF THE THINGS THAT ARE OCCURRING ARE APPROPRIATE, BUT AT LEAST THEN YOU HAVEN'T WAITED UNTIL THE VERY END. ONCE YOU GET TO THAT POINTED, IT'S DIFFICULT AND YOU CREATE ALL KINDS OF OTHER ISSUES IF NOW YOU'RE RAISING SOMETHING THAT COULD HAVE BEEN RAISED EARLY ON. >> AGREED. BARBARA? >> THANKS. YOU KNOW, I THINK I'M GOING SKIP LINDAS AND GO BACK ONE. IS THERE A RIGHT OR A NEED TO ADDRESS THIS ABSENT SCIENTIFIC SORT OF EVIDENCE OF DIFFERENCE? IF I THINK THAT WE LOOKED AT THE PROTOCOLS IN CLINICALTRIALS.GOV NOW, ALMOST NO PROTOCOLS SAY WHITE MEN OR WHITE PRIVILEGED PEOPLE ONLY. THEY ALL SAY -- THEY ALMOST NEVER SAY ACTUALLY WHAT THE RACE AND ETHNICITY DISTRIBUTION WILL BE. SO THE ISSUE, TO ME, IS TO START FROM THE POSITION TO SAY TO THE INVESTIGATOR THROUGH THE IRB, THERE IS THE DEMOGRAPHICS OF THE DISEASE OR CONDITION OR WHAT WE ARE STUDYING. THIS IS WHAT WE EXPECT TO DO BECAUSE WE ARE IN THIS GEOGRAPHY WITH THIS WAY. THIS IS THE CONCLUSION THAT WE ARE GOING TO REACH AND HOW GENERALIZABLE WE THINK IT IS. THESE ARE THE CONSTRAINTS OF TRADE. WHATEVER THE -- MAKE IT ALL THOUGHTFUL, ADVERT ENT AND SORT OF DETERMINED AND INTENTIONAL RATHER THAN IN THE BACK. BUT IF YOU DON'T THEN SAY A CONTINUING REVIEW OR MORE OFTEN, WE SAID WE WERE GOING TO RECRUIT X, Y AND Z. WE RECRUITED X. AND THE IRB DOESN'T COME BACK AND SAY WHERE IS Y AND Z. YOU MISSED -- YOU'RE BACK TO LINDA'S PROBLEM WHICH IS TOO LATE, TOO LITTLE AND TOO EXPENSIVE. BUT IF WE -- AND I CAN TELL YOU THERE ARE LOTS OF OTHER STAKEHOLDERS IN THE UNIVERSE MAKING THOUGHTFUL IMPACTFUL CHANGES. THIS IS ONLY HAVING A SORT OF CENTRAL LOCATION BECAUSE WE KNOW ALMOST ALL INTERVENTIONAL OR ALL INTERVENTIONAL RESEARCH OR ALMOST ALL, GOES THROUGH AN IRB. IT DOESN'T FIX THE DATABASE PROBLEM, WHICH IS A DIFFERENT PROBLEM. >> I'M HEARING -- I'M NOT GOING TO ARGUE FOR JUSTICE AS A PRINCIPLE IF KNOWN ELSE AGREES. I MEAN THIS IS A COMMITTEE DOCUMENT. SO I'M THE -- WE CAN ACKNOWLEDGE JUSTICE IS A PRINCEEL AND ALL OF THAT, BUT ALL OF THE SPECIFIC RECOMMENDATIONS WE ARE TALKING ABOUT SEEM LESS ABOUT JUSTICE AS A PRINCIPLE THAN THEY DO ABOUT THE VALIDITY OF THE RESEARCH. AND THAT'S OKAY. I MEAN, WHATEVER WE DECIDE. I'M NOT SURE IT LEADS TO DIFFERENT RECOMMENDATIONS, CERTAINLY NOT IN BIOMEDICAL. BUT THIS DISCUSSION OF THE SOCIAL PROJECT, ALL OF THAT STUFF, MAYBE JUST DOESN'T NEED TO BE SAID HERE AND NOW. KEVIN AND THEN JANET. >> FIRST OF ALL, I WANT TO ACKNOWLEDGE THAT IT WAS REALLY CHALLENGING AREA TO TRY TO GET ANYTHING OUT. I THOUGHT THE DOCUMENT WAS REALLY HELPFUL IN TRYING TO LAY OUT SOME OF THE ISSUES IN A VERY NUANCED WAY BUT IT'S REALLY, REALLY CHALLENGING. SO JUST ACKNOWLEDGING THAT. JUST QUICKLY I WANTED TO -- I AGREED THAT THE PROGRESSIONAL NORM STATEMENT WAS -- THAT CAUGHT MY EYE BECAUSE I THOUGHT THAT IT EITHER WILL BE IMPOSSIBLE TO SATISFY -- IT JUST SEEMED IMPOSSIBLE TO SATISFY. SO ANYWAY, I JUST WANTED TO LOOK AT THAT AGAIN. IT'S A PRETTY TALL ORDER. AND MAYBE I'M INTERPRETING IT DIFFERENTLY. THE SECOND THING WAS THE SOCIAL PROJECT FRAMING. I WAS 80% OF THE WAY WITH IT BUT I'M HAVING TROUBLE FOLLOWING ALL OF THE THINKING AROUND IT. IT SEEMED LIKE WE'D HAVE TO DEVELOP THAT THOUGHT A BIT FURTHER. AND THEN THE LAST THING I WANTED TO ADD WAS, THE RECOMMENDING THE RESEARCH BE SUPPORTED BY HHS SEEMED LIKE ANOTHER CATEGORY OF RESEARCH IN ADDITION TO WORK ON EQUITY AND INGEST SOCIAL DETERMINANTS OF HEALTH -- INJUSTICE -- WOULD BE MAKING FUNDS AVAILABLE WITHIN PROJECTS FOR THE TYPE OF WORK THAT WAS DESCRIBED IN TERMS OF EVALUATING WHAT HAPPENED WHEN YOU TRY TO USE DIFFERENT MITIGATIONS STRATEGIES. WHAT WERE THEY OR THE ADVERSE EFFECTS OF VULNERABLE POPULATIONS. WHAT WERE SOME OF THE BENEFITS. IT SEEMED LIKE THAT IS A IMPORTANT CATEGORY FOR BIOETHICS RESEARCH. SO PART OF THIS DOCUMENT IS GOING TO BE RECOMMENDING AND SUPPORT. AND IT SEEMS LIKE THAT IS ANOTHER CATEGORY THAT MIGHT BEAR CONSIDERATION. >> I THINK THE INTENT WAS TO DO THAT BUT NOT NECESSARILY ALWAYS PIGGYBACK ON TO AN EXISTING STUDY. NOT JUST COLLECT THE VARIABLES BUT LOOK ATTAINTED VENTION. THAT'S EXACTLY RIGHT -- INTERVENTION. JANET, I THINK? >> IN SUPPORT OF USING JUSTICE AS PART OF THE DOCUMENT, I CAN SUGGEST TWO AREAS. ONE, IF IT'S INTERVENTIONAL TRIAL WHERE THERE ARE POTENTIAL BENEFITS, THEN THE JUSTICE ASPECT IS -- YOU'RE DENYING ACCESS TO THIS POTENTIAL TREATMENT OPTION. BUT ANOTHER IS ALSO THAT IF YOU HAVE TOO MANY BARRIERS TO ENROLLMENT, EITHER THROUGH ELIGIBILITY CRITERIA OR ACCESS TO THE TRIAL SITE, YOU'RE ACTUALLY MAKING OR PUTTING THE PATIENTS WHO DID ENROLL AT RISK OF PARTICIPATING IN A TRIAL, MANY PUT THEIR HEALTH AT RISK WITHOUT ENABLING THE TRIAL TO FINISH SO THAT SOMETHING USEFUL WILL BE LEARNED. AND I THINK THAT IS A JUSTICE ASPECT. >> SO I MEAN, I THINK THAT IS CLEARLY RIGHT. I WOULDN'T HAVE CONSIDERED IT PRIMARILY JUSTICE ISSUE BUT I CAN'T DISAGREE WITH IT. ALL RIGHT. ANYTHING ELSE BEFORE I LOOK AT MY E-MAIL BOX, WHICH HAS BEEN COLLECTING PUBLIC COMMENTS, WHICH ACTUALLY SURPRISINGLY I HAVE NOT BEEN RICH FROM THIS SECTION. I THINK EVERYBODY HAS BEEN TOO BUSY LISTENING. HERE COMES ONE. BEFORE I TURN TO THOSE, THE PUBLIC COMMENTS STARTS IN TWO MINUTES. ANY LAST REMARKS? I WANTED TO JUMP IN AND SAY, TO ME THIS IS ALL ABOUT JUSTICE. IT'S REFRAMING JUSTICE. AND IT'S USING THE LANGUAGE THAT PEOPLE UNDERSTAND IN THE DISCIPLINE TO UNDERSTAND JUSTICE. AND SO, I THINK I'M GOING WITH CONSUELO WHEN SHE TALKS ABOUT SORT OF ADDING SOCIAL JUSTICE, SOCIAL ENTERPRISE, THAT PEOPLE MIGHT NOT UNDERSTAND. BUT THEY UNDERSTAND THE NEED TO CONNECT WITH THE POPULATION THAT THEY ARE WORKING ON SO THAT PERHAPS THEY COULD ACTUALLY GET THEIR DRUGS OUT. I THINK AS BARBARA HAS SAID SO OFTEN, THAT PEOPLE ARE ALREADY WORKING ON THAT. BUT IT'S TO FRAME IT IN A WAY OF JUSTICE THAT THEY UNDERSTAND AND CAN MOVE FORWARD. AND THEN LAST THING I WOULD ADD IS THAT, I SEE THE ROLE OF SOCIAL DETERMINANTS OF HEALTH PLAYING A BIG PART IN RESEARCH. OFTEN WE ARGUE THAT PEOPLE HAVE POOR HEALTH OUTCOMES BECAUSE OF SOCIAL DETERMINANTS OF HEALTH. SO HOW ARE THESE TECHNIQUES, THESE PRODUCTS, THESE DRUGS GOING TO ADDRESS THAT SEPARATE FROM THE LIVED REALITY OF PEOPLE, THE SOCIAL DETERMINANTS OF HEALTH? AND SO TO ME, IT'S JUST CONNECTING THE REALITY OF HOW PEOPLE LIVE AND EXPERIENCE THEIR ENVIRONMENT TO THE RESEARCH THAT WE PLAN TO GET OUT AND TO HELP THEM ADDRESS THESE ISSUES. >> SO IN A WAY, IF I HEAR YOU CORRECTLY, WHAT YOU'RE SUGGESTING, YOU ACKNOWLEDGE THAT IT IS A PRINCIPLE BUT YOU SUGGEST THAT WE USE BASICALLY UTILITY-BASED ARGUMENTS, WHY IT'S IN PEOPLE'S INTEREST TO PURSUE AND GIVE THEM REASONS TO DO IT? >> SO, YES. YES. AND THEN HELP THEM ALONG. BUT I THINK WHAT BARBARA HAS SAID IS THAT PEOPLE ARE ALREADY UNDERSTANDING THAT. SEWED CONTINUE TO REFINE IT IN THE ENGINE THAT THEY UNDERSTAND AND THAT THEY USE -- KNOWLEDGE -- WHILE ALSO CALLING FOR THEM TO BEGIN TO PARTNER WITH PEOPLE WHO DO THIS WORK IN THE SOCIAL DETERMINANTS EVER HEALTH, SO WE CAN WORK TOGETHER TO MAKE THE OUTCOMES BETTER. >> THANK YOU. AND THAT'S A GREAT NOTE TO END ON. WE'LL SEE IF THE PUBLIC COMMENTS ADDED ANYTHING. SO I'M GOING TO GO BACK. THE FIRST ONE WAS RECEIVED DURING OUR DISCUSSION OF PUBLIC HEALTH, PUBLIC HEALTH EXCEPTION. AND THE E-MAIL WAS, IT'S REALLY IMPORTANT TO HAVE REPRESENTATION FROM PUBLIC HEALTH AGENCIES. I BELIEVE I HEARD ONLY ONE PERSON FROM CDC AND NO ONE FROM STATE OR LOCAL HEALTH DEPARTMENTS. IT'S THESE PUBLIC AGENCY THAT HAVE THE RESPONSIBILITY TO PROTECT THE HEALTH OF THE PUBLIC. I WILL JUST COMMENT ON THAT, THAT ONE OF THE ISSUES WE TALKED ABOUT AT OUR PREVIOUS MEETING IS THE LANGUAGE OF THE EXCEPTION IN THE RULES WAS MUCH BROADER THAN THINGS WE CONSIDER PUBLIC HEALTH ENTITIES. SO THAT THAT WAS ONE OF THE AGENDA ITEMS. FOR EXAMPLE, YOU COULD FIT ALMOST EVERYTHING NIH DOES ON THE NON-TRADITIONAL SIDE UNDER THAT DESCRIPTION. AND STOW ONE OF OUR AGENDAS IN THE DOCUMENT WAS TO NARROW THAT DOWN SO IT REALLY WAS A MORE TRADITIONAL INTERPRETATION. BUT OTHER THAN THAT, I THINK WE CAN ONLY HOPE THAT PUBLIC HEALTH ENTITIES WILL LISTEN. THERE IS A FOLLOW-UP TO THAT. I MEANT TO CONTINUE MY COMMENT TO SPECIFICALLY ASK FOR CONSIDERATION OF SURVEILLANCE ACTIVITIES THAT INVOLVE NO CONTACT WITH INDIVIDUALS, ONLY POSSIBLE RISK OF CONFIDENTIALITY; AS EXEMPT EVEN WHEN THEY INCLUDE DATA FROM INDIVIDUALS WHO ARE ORIGINALLY CONSENT FOR RESEARCH. FOR EXAMPLE, LONG TERM SURVEILLANCE FOR INDIVIDUALS IN DRUG TRIALS WERE INVOLVED IN STUDIES OF THE HEALTH EFFECTS OF NATURAL OR MAN MADE DISASTERS. SO I THINK THAT THOSE -- IF THEY MET THE CRITERIA FOR BEING DIRECTED BY PUBLIC HEALTH AGENCY AND MEETING THE DEFINITION OF A PUBLIC HEALTH SURVEILLANCE ACTIVITY, I THINK THOSE THINGS MIGHT -- CERTAINLY WOULD BE ELIGIBLE TO BE CONSIDERED ACCEPT ACCEPTED. BUT I DON'T KNOW IF ANYONE DISAGREES WITH THAT. AND THERE IS ANOTHER ONE. THIS INCLUDES SURVEILLANCE BY LINKAGE OF RESEARCH RECORDS WITH VITAL STATS AND CANCER REGISTRY REGISTRIES. TO BE CONSIDERED ACCEPTED. >> SO THOSE TOPICS ARE IN OUR DISCUSSION IN THE SUMMER. THE. >> I THINK SO TOO. I MEAN I THINK THE BOTTOM LINE IS ALL OF THOSE HAVE TO BE TAKEN ON A CASE-BY-CASE BASIS. I DON'T THINK -- I THINK THAT THE THEME I TOOK AWAY FROM THAT IS WE WANT TO BE CAUTIOUS AND OPENING BROAD INTERPRETATION OF THE PUBLIC HEALTH EXCEPTION. THE WORST THAT WILL HAPPEN IS SOMETHING LIKE THAT GETS -- OR HAS AN EXEMPT DETERMINATION OR GOES THROUGH EXPEDITED REVIEW, WHICH REALLY ISN'T SO BURDENSOME BURDENSOME. AND THE DANGER OPENING IT TOO WIDE IS WE'LL HAVE RESEARCH ON PEOPLE THAT REALLY SHOULD HAVE BEEN DONE WITH THEIR CONSENT OR WHICH THEY SHOULD BE AWARE OF THAT JUST GETS DONE BECAUSE YOU CONSIDER IT AN EXCEPTION. SO THEN WE MOVE ON TO THE NEXT SECTION ON BYSTANDER RISK. AND THE COMMENT IS, AT THE ARMY HOSPITAL I WORK AT, WE USE SUBJECTS AND PARTICIPANTS THAT MEAN THE SAME THING. BOTH SIGNED INFORMED CONSENT. I THINK THAT REFLECTS SOME OF THE DISCUSSION THAT IT WAS THEE LET CALL INTEREST AND MAYBE THESE COULD BE USED, BUT IT'S A PRACTICAL MATTER AND WE DO TREAT THESE TWO TERMS THE SAME IN THE REGULATIONS WE USE SUBJECT AND IN MORE PROGRESSIVE SITUATIONS, WE USE PARTICIPANT TO ACKNOWLEDGE WHAT PEOPLE GIVE TO THE RESEARCH ENTERPRISE, BUT WE ARE USUALLY TALKING ABOUT THE SAME PEOPLE. SO I THINK THIS IS FAIR AND I THINK IT'S WHERE WE ENDED UP. THIS WAS AT 12:50. REGARDING LEGAL SACHRP SHOULD COMMENT ON CHANGES AND RECOMMENDATION. THERE IS A DISCONNECT DURING THE CURRENT REGULATORY FRAMEWORK IN THAT CRITERIA FOR APPROVAL DO NOT ADDRESS PERSONS WHO ARE SUBJECTS WHILE AT THE SAME TIME INVESTIGATORS AND IRBs ARE TASKED WITH ADDRESSING OTHERS IN REGARDS TO STATED PROBLEMS. SO THIS IS STILL BACK WITH THE BYE STANDER RISK. AND I THINK WE ACKNOWLEDGED THAT. REVISIONS TO THE REGULATORY FRAMEWORK WOULD PROVIDE A PROACTIVE OPPORTUNITY TO MINIMIZE RISKS THAT RESEARCH MAY PRESENT TO OTHERS CONSIDERING WHETHER THOSE RISKS ARE REASONABLE, AND TO CONSIDER WHETHER THOSE ARE -- WHETHER THERE ARE ADEQUATE PROVISIONS FOR MONITORING THE SAFETY, ET CETERA. THE CURRENTS FRAMEWORK PLACES IRBs IN A REACTIVE MODE ADDRESSING ISSUES -- [ INAUDIBLE ] HOW OTHERS FEEL THAT? I THINK THIS GOES BACK TO THE SUBCOMMITTEE DISCUSSIONS AND WHETHER THERE IS A PROBLEM HERE. I THINK THAT THE PEOPLE ON THE SUBCOMMITTEE LARGELY FEEL THAT IRBs -- IF AN IRB SEES A PROTOCOL, IT PUTS THE POPULATION AT RISK. IT'S NOT THE RESEARCH POPULATION. THEY ARE USED TO DEALING WITH THAT. AND THEY'LL DO IT AT THE TIME OF APPROVAL EVEN THOUGH THIS SPECIFIC 111 CRITERIA ARE ALL FOR SUBJECTS. AND WE DO IT ROUTINELY WITH PREGNANT PARTNERS AND SOME OTHER POPULATIONS AND THEN WE DO IT WITH -- INSTITUTIONS DO IT WITH OTHER REVIEW COMMITTEES THAT TYPICALLY INFORM THE IRB. SO, I THINK THAT -- I KNOW THE SUBCOMMITTEES WOULD FEEL THERE IS NO NEED FOR REGULATORY CHANGE ON THIS PARTICULAR ISSUE. I THINK IF WE DO FEEL IT'S -- I THINK SACHRP KNOWS THAT IF WE DO FEEL SOMETHING IS IN NEED OF REGULATORY CHANGE, WE ARE NOT SHY ABOUT RECOMMENDING THAT, ALTHOUGH WE ARE REALITY-BASED TOO. SO WE DON'T HAVE TO TURN TO THAT FREQUENTLY. ANY OTHER THOUGHTS ON THIS ONE? SO HERE IS ONE THAT YOU'LL APPRECIATE. THIS IS THE TAKEHOME FOR NEXT TIME. SO THIS WAS AT 1:00. SO RIGHT BEFORE WE RECONVENED. SO, FOR THOSE OF YOU WHO WERE -- SO WE WERE ON THE PUBLIC WEBCAST DURING OUR LYNCH BREAK. SO WHEN WE RECONVENED AND HAD INFORMAL DISCUSSIONS AMONG SOME OF THE PARTICIPANTS, THEY SAY PLEASE WARN YOUR SPEAKERS WE CAN HEAR THEM. SO, WE'LL HAVE TO -- JULIA, WE HAVE TO REMEMBER NEXT TIME TO REMIND PEOPLE OF THAT. WE DO IT AT THE BEGINNING BUT WE DIDN'T DO IT -- I SHOULD HAVE DONE IT AT THE LUNCH BREAK. AND THEN WE HAVE ONE LAST COMMENT THAT WAS RECEIVED IN THE CONTEXT OF THE JUSTICE DISCUSSION. THE FACT THAT IRBs TYPICALLY IGNORE ONE OF THE THREE BELMONT PRINCIPLES, FLIES IN THE FACE OF OUR CLAIMS THAT WE BASE OUR ETHICAL REVIEW ON BELMONT! I AM HOPING THAT SACHRP WILL LEAD AN EFFORT TO BRING OUR COMMUNITY TO FOCUS ON THIS. IF NOT NOW, WHEN? SO -- >> NOT US, WHO? JUST TO FINISH THE SENTENCE. >> I THINK IT'S TRUE. I THINK IGNORE, IN MY EXPERIENCE, IS AN OVERY STRONG. BUT I DON'T THINK THAT -- OVERLY STRONG -- I DON'T THINK IRBs IGNORE WHAT THEY THINK OF IS JUSTICE, BUT I THINK PART OF WHAT WE NEED TO DO IS ARTICULATE THE EXTENT OF JUSTICE FOR IRBs. I MEAN, I THINK IRBs DO CONSIDER 111A3 EQUITABLE SELECTION. BUT I THINK THEY HAVE BEEN RELATIVELY MODEST IN THEIR INTERPRETATION OF WHAT THAT MEANS. SO THAT IS ALL THE PUBLIC COMMENTER. SKIP? >> JUST A COMMENT. I'M REMINDED OF THE DIFFERENCE BETWEEN, IN TERMS OF THE DEBATE ABOUT BLACK LIVES MATTER F I MAY AT RISK TO SAY THIS. THAT THE DIFFERENCE BETWEEN SAYING I'M NOT A RACIST BY SAYING I'M ANTI-RACIST, IF I COULD MAKE A DISTINCTION. A PROTOCOL DOESN'T USUALLY SAY, WE ARE ONLY GOING TOW LOOK FOR CAUCASIANS T DOESN'T SAY THAT T WILL GIVE INCLUSION CRITERIA. I THINK THE QUESTIONS OR THE CHALLENGE, THE IRB LOOKS AT THAT AND THEY DON'T SEE ANY EXCLUSIONS. THEY DON'T SEE YOU'RE GOING TO DO THIS. THE CHALLENGE IS IF -- LIKE THE POINT MADE BIOEN ABOUT STANFORD UNIVERSITY WHERE THEY ARE LOCATED AND THEY DON'T EVEN GO OUT INTO THE NEIGHBORHOOD. IT'S THAT ACTED IRVA COMPONENT THAT THE IRB IS NOT LOOKING AT. ACTIVELY GOING TOUT MAKE SURE THAT YOU'RE GETTING THAT REPRESENTATIVE POPULATION. THE IRBs ARE BEING PASSIVE AND I THINK THAT IS THE DISTINCTION THAT WE NEED TO BEGIN TO MAKE. WHAT DOES IT MEAN TO BE ACTIVELY ENGAGED IN ASSURING EQUITABLE SELECTION, NOT JUST PASSIVE LIE SAYING THE PROTOCOL IS NEUTRAL IF YOU WILL TO ANY SELECTION BIAS BUT THEN THE SELECTION BIAS IS WITHIN OUR INSTITUTIONAL FORMS OF HOW WE OPERATIONALIZE RESEARCH. THAT'S THE CHALLENGE. I DON'T THINK IRBs ARE MISSING THIS BUT THEY ARE BEING PASSIVE. THE QUESTION IS, CAN WE MOVE THEM INTO BEING ACTIVE? >> I THINK IT'S RELATED TO THE ISSUE OF THAT IT'S RELATIVELY EASY TO PRESCRIBE EXCLUSION OF EXPLOITED -- TO AVOID EXPLOITATION OF INDIVIDUALS, IT'S MUCH HARDER TO PROMOTE INCLUSION OF POPULATIONS. AND IRBs HAVEN'T REALLY TAKEN THAT ON TO A LARGE EXTENT. THAT'S WHAT WE ARE TALKING ABOUT. CONSUELO? >> I THINK HIS POINT IS REALLY IMPORTANT IN THAT WHERE IS THAT OPPORTUNITY FOR SOME ACCOUNTABILITY AFTER THE STUDY STARTS? SO IN THE CONTINUATION REVIEW EVERY YEAR, WHEN THEY ARE COURTING, HOW MANY PEOPLE HAVE THEY RECRUITED AND WE SEE THERE IS A DISCREPANCY BETWEEN WHAT THEY PLANNED AND WHO THEY ARE RECRUITING. AND THEN WHAT KIND OF EXPECTATION SHOULD THERE BE THAT THERE IS A JUSTIFICATION AROUND AND A CHANGE IN PLAN FOR HOW THEY ARE GOING TO RECRUIT OR ENGAGE OR WHATEVER OTHER THINGS THAT THEY ARE GOING TO BE DOING. >> IF I COULD JUST ADD ONE MORE THING. I DON'T KNOW IF THIS WOULD BE WHAT BARBARA MIGHT HAVE SAID IF SHE HAD TIME SO SAY SOMETHING ABOUT THE HRPP. BUT IF I'M LIVING IN AN INSTITUTION AS A SINGLE INVESTIGATOR, THE BURDEN OF TELLING ME I HAVE GOT TO GO OUT INTO THE COMMUNITY, I HAVE TO GO INTO NORTH PHILADELPHIA OR EAST PALO ALTO OR SOMETHING. UNLESS THE INSTITUTION ITSELF HAS A COMMITMENT TO FACILITATE OR TO SUPPORT, TO GIVE ME THE RESOURCES TO DO THAT, I MEAN, I WOULD BE AT A TOTAL LOSS. SO I THINK WE NEED TO INCLUDE THAT INSTITUTIONAL COMPONENT INTO THIS. IT'S NOT ABOUT THE IRB. I MEAN THEY CAN HOLD THE INVESTIGATOR ACCOUNTABLE BUT AT THAT POINT, IF THEY DON'T HAVE INSTITUTIONAL SUPPORT TO DO THAT, THEY'LL BE FLOUNDERING. >> I THINK THAT IS TOTALLY FAIR. I KNOW FROM MY EXPERIENCE AS AN IRB CHAIR, WE WOULD COLLECT ENROLLMENT INFORMATION OBVIOUSLY REVIEWING THE SITES AND THE PROTOCOLS. WE NEVER ASKED ABOUT TO BREAKDOWN THOSE NUMBERS. SO IF A PROTOCOL WAS AT 10% OF ITS ENROLLMENT GOAL, FOR WHERE IT SHOULD BE AT THAT TIME, WE WOULD CERTAINLY QUESTION THAT AND ASK THEM WHAT THEY WERE DOING ABOUT IT AND ASK THEM TO EXPLAIN IT. WE NEVER EVEN KNEW WHETHER THE DISTRIBUTION -- WE NEVER THOUGHT TO ASK WHETHER THE DISTRIBUTION ACROSS POPULATIONS WAS MEETING THEIR PLAN WHEN THERE WAS EVEN SUCH A PLAN. SO AND I KNOW BARBARA AND THE MRCT RECOMMENDATIONS CALLED THAT AS AN EXPLICIT TIME TO DO THAT. BUT THOSE THINGS HAVE TO BE REPORTED IN ORDER FOR THE IRB TO ACT UP. WELL, WE ARE AT THE END OF OUR TIME. WE HAVE 15 MINUTES FOR CLOSING COMMENTS. SO WE CAN CONTINUE THIS DISCUSSION FOR ANOTHER 15 MINUTES. I THINK -- I STILL STRUGGLE. I HAVE UNTIL MARCH BEFORE I RETURN THIS DOCUMENT TO YOU AGAIN. I WOULD ENCOURAGE PEOPLE, IF THEY WANT TO, AND I'LL TALK TO JULIE ABOUT HOW WE CAN MAKE THIS HAPPEN, BUT THERE ARE PARTICULAR ISSUES THAT YOU FEEL PASSIONATE ABOUT OR PARTICULAR INTERESTED IN, WE'LL FIGURE OUT SOME MECHANISMS SO YOU CAN JOIN THE CONVERSATIONS. SKIP? >> LET ME ASK CONSUELO AND PERHAPS OTHERS, BECAUSE I WAS THINKING ABOUT THIS AND I TOOK A VERY BRIEFLY LOOK AT THE 317-PAGE DOCUMENT PRODUCED BY MRC. TO THIS ISSUE. AND I GUESS MY QUESTION IS, WOULD IT HELP INFORM THE DOCUMENT THAT YOU'RE WORKING ON, STEPHEN, TO LOOK AT SOME EXAMPLES AND SOME GOOD AND BAD CASES? IN OTHER WORDS, CASES WHERE IT WAS DONE RIGHT, CASES WHERE IT WAS DONE POORLY. I'M ALSO THINKING ABOUT SOME OF THE PRODUCT-RELATED CASES WHERE DIFFERENCES WERE FOUND BETWEEN POPULATIONS AND WHETHER THAT WAS DONE INTENTIONALLY OR JUST STUMBLED UPON OR DONE AS A PART OF POST MARKETING SURVEILLANCE? WHETHER LOOKING AT SOME OF THOSE CASES WOULD HELP SORT OF TAKE -- I THINK FUNDAMENTALLY STEPHEN IT'S A GOOD DOCUMENT DESPITE MY COMMENTS, BUT TRY TO BRING IT DOWN TO THE WORLD OF THE IRB THINKING ABOUT WHAT THEY NEED TO DO ABOUT A PROTOCOL. WOULD THAT BE USEFUL? >> SO, I DON'T KNOW SO I LOOK AT THE MRCT DOCUMENT T HAS A LOT OF EXAMPLES, A LOT OF STUFF. AND I LOOK AT IT AND I THINK WHY ARE WE EVEN BOTHERING? BECAUSE THERE IS REALLY VERY LITTLE CONCRETE THAT WE ARE GOING TO SAY THAT'S NOT ALREADY CAPTURED IN THEIR TOOLS. AND THEY HAD A MUCH LARGER STAKEHOLDER GROUP THAT HAD A SPECIFIC INTEREST IN THIS TOPIC. WHEREAS HERED WE ARE, WE ARE SACHRP AND WE ARE GENERA GENERALISTS. I DON'T WANT TO -- I THINK IT'S IMPORTANT BECAUSE PEOPLE LISTEN TO US AND WE MAKE RECOMMENDATIONS TO THE SECRETARY AND THAT'S WHAT WE SHOULD BE DOING. I DON'T WANT TO REPRODUCE WHAT OTHERS HAVE BEEN DONE BETTER. >> THAT WASN'T MY INTENT. MY INTENT WAS TO KEEP IT HIGH LEVEL BUT WHETHER OR NOT -- THAT THE POINT CAN BE SEEN AS SOMEWHAT DISEMBODIED LANGUAGE CAN BE TRUNCATED AND IN A VERY SUCCINCT WAIT WITHOUT -- I'M NOT SUGGESTING WE TRY TO REPRODUCE IT BUT WHETHER THERE IS SELECT CASES THAT MIGHT HELP US BRING THAT LANGUAGE DOWN-TO-EARTH, IF YOU WILL. THAT'S ALL. >> I THINK IT'S A GREAT IDEA AND SKIP, I WOULD INVITE YOU TO -- >> I WOULD BE INTERESTED. IF THERE IS SOME CASES THAT CONSUELO WOULD SUGGEST OR OTHERS THAT MIGHT SERVE BOTH AS -- AND I'M NOT SUGGESTING THAT THEY GO INTO THE DOCUMENT. I'M SUGGESTING THEY HELP INFORM OUR DELIBERATIONS. >> THAT'S INTERESTING. YES. >> I'M JUST SAYING IT WOULD BE HELPFUL FOR ME TO SORT OF SEE -- I THINK ABOUT LIKE -- I DON'T REMEMBER THE NAME OF DRUG. IT WORKED IN AFRICAN-AMERICANS. DIDN'T WORK IN -- I THINK THE FDA AND THE COMPANY JUST TRIPPED OVER THAT FINDING. I DON'T THINK THEY WENT LOOKING FOR IT. BUT THEN THEY WENT LOOKING FOR IT AFTER THEY TRIPPED OVER IT. SO, YOU KNOW, I'M JUST WONDERING IF THERE ARE WAYS TO LOOK AT SOME EXAMPLES TO HELP I BELIEVE FORM OUR DELIBERATIONS IN A WAY THAT WOULD HELP US PROVIDE MORE CONCRETE ADVICE. >> SKIP, THAT IS VERY GERMANE. LET ME ASK SOMETHING. SO THE NEXT MEETING IS IN MARCH. TO SOME EXTENT, AND I HAVE READ SOME OF THOSE EXAMPLES AND I READ I DON'T REMEMBER WHERE BIIN THE LAST COUPLE OF MONTHS. ISSUES ABOUT DIFFERENT PRESCRIBING GUIDELINES AND HOW MUCH IMPACT, HOW THEY ARE BASICALLY MISGUIDED BECAUSE THEY EXCLUDE DRUGS THAT WOULD BENEFIT. THE NUMBERS JUST DON'T WORK OUT. EVEN THOUGH -- ANYWAY. I WONDER WHETHER THAT SHOULD BE THE FOCUS OF A PANEL NEXT TIME? TO GET SOME PEOPLE TO COME AND PRESENT THEIR FINDINGS WITH A COUPLE OF THOSE CASES. WE COULD ALL LISTEN TO THEM. >> STEPHEN, I WONDER IF YOU WOULD SAY A LITTLE BIT ABOUT HOW YOUR APPROACH TO PREPARING THE DOCUMENT. BECAUSE I THINK -- I MEAN I LEAVE WORK AND HEALTH EQUITY, RACIAL EQUITY AND WE START WITH THE FUNDAMENTAL QUESTION LINKED TO ANALYZING THE PROBLEM. AND DEFINING THE PROBLEM, ANALYZING THE PROBLEM. SO WHAT IS IT THAT WE KNOW OR PRESUME TO BE AN INTECH TEE LINE OF INJUSTICE -- INEQUITY -- AND WHAT IS THE EVIDENCE THAT SUPPORTS THAT? SO I'M SURE SOME OF THE THINGS THAT WERE JUST MENTIONED THAT WERE PRESENTED TO US ALREADY, WAS FROM ALL OF OUR PANEL EFFORTS, THERE IS EVIDENCE THAT ALREADY WILL HELP US DEFINE WHAT THAT PROBLEM IS. AND THEN, GOING THROUGH THE PROCESS OF WHAT ARE THE POSSIBLE RECOMMENDATIONS AND HOW DO WE NAIL THOSE RECOMMENDATIONS -- WHAT IS OUR CONFIDENCE AND THE EVIDENCE WE HAVE THAT THOSE -- THAT THOSE RECOMMENDATIONS ARE GOING TO HELP US ACHIEVE EQUITY OR CLOSE THAT GAP? AND THEN I THINK AN IMPORTANT PIECE FOR THAT, TO ME, IS ARE THOSE RECOMMENDATIONS REALLY CENTERED IN THE PEOPLE WHO ARE BEING DISPROPORTIONATELY IMPACTED? AND THAT CAN BE DIFFICULT WHEN WE ARE TALKING ABOUT AS SOMETHING AS BROAD AS THIS AS CLINICAL RESEARCH. BUT WHAT EVIDENCE DO WE HAVE, WHAT WE ARE RECOMMENDING REALLY LOOKS LIKE? THOSE PRIORITIES AND VALUES AND SYSTEMS? AND SO I THINK THAT IS AGAIN A PART OF THE DEVELOPMENT OF THE PROPOSAL AND RECOMMENDATIONS EMBEDDING OF THEM. AND THEN THE FEASIBILITY BEING REALLY PART OF THE LAST PIECE. SO THINKING THROUGH, DO YOU HAVE QUESTIONS THAT HAVE BEEN DEVELOPED AND THAT ARE GUIDING THIS MULTI-STEP PROCESS OF COMING UP WITH SOME RECOMMENDATIONS? >> SO, JUST IN TERMS OF PROCESS, WE STARTED WITH A CHARGE. SO THERE IS A FORMAL CHARGE WHICH ASKS US QUESTIONS WHICH ARE HIGHLIGHTED IN THE -- AND THEY ARE VERY CONCRETE. AND I THINK THIS IS PART OF THE CHALLENGE. HOW FAR BACK DO WE HAVE TO GO TO ANSWER THOSE QUESTIONS? AND THERE ARE PRACTICAL CONSIDERATIONS TOO. YOU COULD WRITE A LOT ON THIS AND IF WE TOOK ON DOING BASICALLY AN ACADEMIC PAPER WITH JUSTIFICATIONS AND LITERATURE AND -- I'M NOT SURE HOW PRACTICAL THAT IS. THESE ARE SUPPOSED TO BE DOCUMENTS WRITTEN BY THE COMMITTEE. AS A MATTER OF FACT, THERE IS ONE PERSON THAT GETS TO DRAFT THEM AND WE BASICALLY -- THE SUBCOMMITTEES ACT AS STAFF. BUT THEY ARE NOT MEANT TO BE -- SO I APPRECIATE -- I THINK THAT IS THE RIGHT WAY TO DO IT. BUT I THINK IT SEEMS MORE PRACTICAL TO ME IF WE FEEL THAT THAT IS WHAT NEEDS TO BE DONE, THAT WOULD BE OUR RECOMMENDATION. BECAUSE THAT IS NOT SOMETHING -- THAT'S NOT -- SACHRP IS SAY BUNCH OF PEOPLE WHO GET-TOGETHER TO ASK QUESTIONS AND MAKE RECOMMENDATIONS. IT'S NOT AN ACADEMIC THING EVERYBODY SERVES. SO I THINK IF WE COULD ARTICULATE THAT NEED, THAT WOULD BE A RECOMMENDATION. BUT THAT BE DONE AND THAT SPECIFIC OUTCOMES OF THAT BE USED TO INFORM RECOMMENDATIONS TO THE IRB. DOES THAT MAKE SENSE? I DON'T WANT TO COME ACROSS AS SORT OF TRYING TO GET OUT OF DOING THAT. BUT I MEAN, I THINK IT'S A GREAT IDEA. BUT IT'S REALLY NOT EQUIPPED WITH THE RESOURCES FOR MYSELF OR THE COMMIT I TO DO THAT WELL. >> I MEAN, I DO THINK IT IS WHAT IT IS. THAT'S PROBABLY NOT WHAT I SHOULD SAY. BUT THAT'S THE REALITY, BUT IF WE ARE REALLY TRYING TO -- TALKING ABOUT SOMETHING AS BIG AS JUSTICE AND WHAT WE ARE DEALING WITH NOW IS SORT OF THE RECKONING WITH THERE IS SO MUCH INJUSTICE THAT IF WE TRULY WANT TO CHANGE THINGS, THEN YOU SHOULDN'T BE EXPECTED, THIS GROUP COULDN'T BE EXPECTED TO HAVE ALL THE KNOWLEDGE AND INFORMATION. OF ACTUALLY GATHERING AND SYNTHESIZING EVIDENCE THAT REALLY REPRESENTS GLENN A BROAD -- THE BROAD ARRAY OF DATA AND INFORMATION THAT IS AVAILABLE, INCLUDING SOME THAT MIGHT BE HIDDEN FROM THE USUAL PLACES THAT WE LOOK. AND I THINK THAT IS GOING TO BE REALLY IMPORTANT AS WELL BECAUSE WE OFTEN GO TO SOURCES OF INFORMATION THAT WE KNOW ABOUT AND SOME OF THE MOST IMPORTANT AND USEFUL INFORMATION WILL NOT BE PUBLISHED, WILL BE IN THE HANDS OF COMMUNITY MEMBERS, WILL BE IN THE HANDS OF JUSTICE INNEREQUITY WARRIORS AND SO IF WE ARE GOING TO CREATE SOME DOCUMENT THAT REALLY IS GOING TO HELP US CHANGE SYSTEMS, THEN WE HAVE TO CONSIDER WHAT INFORMATION WE'LL BE MISSING. >> SO, I'M GOING TO GIVE YOU -- [ FEEDBACK ] >> I WANT TO CAUTION THAT YOU HAVE A HARD STOP IN FOUR MINUTES. >> OKAY. FOUR MINUTES. SO I'M GOING TO CHALLENGE THE COMMITTEE AND THE SUBCOMMITTEES, BASICALLY TO ASSEMBLE THOSE PEOPLE. THE ONLY WAY WE ARE GOING TO HEAR FROM THEM IS TO CALL THEM TO THE COMMITTEE. LIKE WE DID TODAY, WITH THE PEOPLE WHO PARTICIPATED IN THE PANEL. I MEAN, I DON'T THINK -- SO THIS IS AN URGENT BUT IT'S NOT SOMETHING WE WILL FIX QUICKLY. SO I DON'T THINK WE SHOULD DO THIS IN A HURRY OR NOT DO WHAT WE SHOULD DO. SO,. [ FEEDBACK ] I WILL ASK THE COMMITTEE AND ANYONE WHO PARTICIPATED IN THE PANEL AND SUBCOMMITTEE MEMBERS, LET'S START PUTTING TOGETHER A PANEL FOR MARCH. IT USED TO BE HARD TO DO PANELS BECAUSE YOU HAD TO TRAVEL EVERYBODY AND THERE WERE COSTS AND ALL OF THAT. VIRTUAL PANELS, PEOPLE JUST NEED TO BE WILLING TO DEVOTE THE TIME. SO IT IS AN OPPORTUNITY. ONE OF THE FEW THINGS THAT WORKS BETTER THIS WAY. SO, THREE MORE MINUTES. >> STEPHEN, IF I COULD HELP, PLEASE, LET ME KNOW. >> THAT WOULD BE GREAT, THANK YOU. I WAS HOPING YOU WOULD VOLUNTEER. >> STEPHEN, I WOULD JUST PUT IN A VOTE FOR EVERYONE TO REALLY READ THE MRCT DOCUMENTS BECAUSE IN MY VIEW, THESE ARE -- THEY ARE ENCYCLOPEDIC AND HAVE A TREMENDOUS -- AND I HAVE NO DOUBT THAT THEY WILL BE THE STANDING RESOURCE IN THIS FIELD, THE EVIDENTIARY BASIS FOR SOME TIME TO COME. SO, IT'S A TREMENDOUS RESOURCE. AND IT HAS A LOT OF -- IT ADDRESSES MANY OF THE ISSUES. NOT ALL OF THEM THAT WERE RAISED. >> APPROVE THE JULY MINUTES, PLEASE. >> I WOULD INVITE A MOTION TO APPROVE THE MINUTES FROM JULY. >> SO MOVED. >> SECOND. >> MOVED AND SECONDED. I'M JUST GOING TO ASK YOU ALL TO RAISE YOUR HANDS IF YOU SAY, YES. >> THANK YOU. >> CLEARLY THE MAJORITY. THANK YOU. AND THEN WE HAVE TWO MINUTES. SO THANK YOU ALL T HAS BEEN AS ALWAYS, A PLEASURE. AND WE WILL TALK AGAIN -- NO, I MIGHT. BUT YOU WILL TALK AGAIN IN MARCH AND THEN THERE IS A SUBCOMMITTEE MEETING IN NOVEMBER AND IT GOES ON. GREAT CONVERSATIONS TODAY. >> THANK YOU STEPHEN.