WELCOME, EVERYBODY. THIS IS JERRY MENIKOFF. IT'S A PLEASURE TO SEE YOU HERE. I WANT TO THANK THE MEMBERS, SUBCOMMITTEE MEMBERS, EX-OFFICIOS, MEMBERS OF THE PUBLIC, THANK YOU ALL FOR BEING WILLING TO GIVE OF YOUR TIME AND EFFORT TO PARTICIPATE IN THIS WORTHY ENDEAVOR. I WANT TO THANK AS WE DO EVERY TIME, IT'S IMPORTANT TO THANK ALL THE WORK THAT IS DONE BETWEEN THE MEETINGS BY IN PARTICULAR THE MEMBERS OF THE SUBCOMMITTEES AND THOSE MEMBERS OF, WE'RE LOOKING FORWARD TO AN INTERESTING TWO DAYS OF WORK. I PARTICULARLY WANT TO WELCOME, STEPHEN WILL WELCOME THEM MORE FORMALLY IN A MOMENT, WE HAVE TWO NEW MEMBERS HERE IN PERSON, DR. KATZ AND PROFESSOR WOLF, IT'S REALLY SOMETHING WE'RE VERY, VERY MUCH LOOKING FORWARD TO GETTING YOUR INPUT AS YOU SERVE ON SACHRP. LET ME JUST SAY ONE THING IN TERMS OF AN UPDATE ON WHERE THINGS ARE AT IN TERMS OF THE COMMON RULE REVISIONS. IN ONE SENSE, IT HASN'T ALTERED THAT MUCH FROM WHAT I HAD MENTIONED IN THE PRIOR SACHRP MEETING, WHICH IS THAT WITHIN HHS, THE REVISIONS TO THE COMMON RULE ARE BEING REVIEWED, BUT THAT REVIEW IS FURTHER ALONG IT IS A VERY THOROUGH REVIEW, THEY WANT TO MAKE SURE THEY'RE DOING A THOROUGH REVIEW OF THE CHANGES. IF I CONSULTED MY MAGIC 8 BALL AND ASKED IS IT LIKELY THAT WE'LL HAVE AN OUTCOME FROM THIS FAIRLY SOON, I THINK IT MIGHT ACTUALLY SAY, YOU KNOW, SIGNS POINT TO YES. SO THAT WOULD BE GOOD. IT IS STILL TRUE AS I INDICATED AT THE LAST MEETING THAT WE HAVE NOT GOTTEN ANY INDICATION, THEY HAVE NOT MENTIONED SPECIFIC THINGS IN THE REVISIONS THAT THEY'RE LIKELY THAT THEY WANT CHANGE, PARTICULAR SUBSTANTIVE PROBLEMS WITH WHAT HAS BEEN PROPOSED. AGAIN, THERE ISN'T A FINAL DECISION ON ANY OF THIS. AS I MENTIONED BEFORE, I DON'T THINK -- A LOT OF PEOPLE WOULDN'T FIND IT PARTICULARLY SURPRISING IF WHAT CAME OUT OF THIS REVIEW MIGHT BE THAT WE END UP -- THERE'S SOME SORT OF DELAY IN THE COMPLIANCE DATE WITHOUT A CHANGE IN ANY OF THE OTHER SUBSTANTIVE PROVISIONS. AGAIN, IT'S STILL UNDER REVIEW, THERE HASN'T YET BEEN A FINAL DECISION, BUT THAT'S PRETTY MUCH WHERE THINGS ARE AT. SO HOPEFULLY PEOPLE VIEW THAT AS MOVING FORWARD AND A GOOD THING. I THINK THAT'S ALL I HAVE TO SAY FOR NOW. I'LL HAND IT OVER. >> I'LL SECOND JERRY'S WELCOME. I GUESS GLASS HALF FULL OR LOOKING ON THE BRIGHT SIDE, IT GIVES US MORE TIME TO TALK ABOUT THIS STUFF BEFORE IT ACTUALLY HAS AN IMPACT ON PEOPLE. AND THERE IS, AS WE STARTED TO TALK ABOUT LAST TIME, THINK THE AGENDA TODAY IS GOING TO TAKE US DEEPER INTO TOPICS LARGELY THAT WE'VE ALREADY COVERED, AT LEAST FOR TODAY. BUT THAT RAISE SUBSTANTIVE ISSUES SO I HOPE YOU ALL PARTICIPATE IN THE DISCUSSION. I WOULD LIKE TO FORMALLY WELCOME DR. CATS AND PROFESSOR WOLF. WE HAD TWO OTHER MEMBERS WHO JOINED US LAST TIME. SO DR. KATZ IS THE DIRECTOR OF THE CONSORTIUM ETHICS PROGRAM AT THE UNIVERSITY OF PITTSBURGH. SHE'S A PHYSICIAN IN THE DEPARTMENT OF PEDIATRIC GENERAL AND THORACIC SURGERY AT THE CHILDREN'S HOSPITAL OF PITTSBURGH. JUST AS AN ASIDE, I DON'T KNOW WHAT OTHER PEOPLE'S IRB EXPERIENCE HAS BEEN, BUT WE'VE ALWAYS HAD DIFFICULTIES RECRUITING SURGEONS TO THE IRB, SO I THINK IT'S WONDERFUL TO HAVE SOMEONE WITH A SURGERY BACKGROUND ON SACHRP. I THINK THAT'S A PERSPECTIVE THAT'S MUCH NEEDED. ALSO ASSISTANT PROFESSOR OF SURGERY PROVIDING CLINICAL ETHICS EDUCATION TO RESIDENTS AND STUDENTS AND SERVES WITH THE ETHICS CONSULTATION SERVICE AT THE CHILDREN'S HOSPITAL OF PITTSBURGH. AND AS VICE CHAIR OF THE UNIVERSITY OF PITTSBURGH'S INSTITUTIONAL REVIEW BOARD. I'LL STOP THERE. HER BIO GOES ON WITH ADDITIONAL AND RELEVANT ACTIVITIES TO SACHRP. PROFESSOR WOLF IS PROFESSOR AND DIRECTOR OF THE CENTER FOR LAW, HEALTH AND SOCIETY AT GEORGIA STATE UNIVERSITY COLLEGE OF LAW. HE HAS A JOINT APPOINTMENT WITH THE SCHOOL OF PUBLIC HEALTH, CONDUCTS RESEARCH IN A VARIETY OF AREAS IN HEALTH AND PUBLIC HEALTH LAW AND ETHICS WITH A PARTICULAR IMFA CYST ON RESEARCH ETHICS. BEFORE JOINING THE LAW SCHOOL, SHE WAS ON THE FACULTY OF UCSF, CENTER FOR AIDS PREVENTION STUDIES WHERE SHE PROVIDED CONSULTATION TO HIV RESEARCHERS ABOUT ETHICAL DESIGNS OF THEIR STUDIES. SHE ALSO SERVED ON THE UCSF INSTITUTIONAL REVIEW BOARD AS WELL AS THE ADVISORY COMMITTEE REGARDING STEM CELL RESEARCH AND ON THE GENERAL CLINIC RESEARCH CENTER'S ADVISORY COMMITTEE, AND I WILL STOP THERE, ALTHOUGH THERE'S MORE. SO THANK YOU BOTH FOR JOINING US. I EXPECT YOU TO BRING INTERESTING AND UNIQUE PERSPECTIVES, AND I HOPE YOU ENJOY OUR DELIBERATION. >> BEFORE WE GO ANY FARTHER AND PERHAPS AT THE START IT WOULD HAVE BEEN GOOD, COULD WE JUST DID AROUND FOR THE SAKE OF THE WEBCAST AND EVERYONE JUST ANNOUNCE THEMSELVES, WHO THEY ARE AND WHERE THEY'RE FROM BRIEFLY? >> MY NAME IS REID PEER ET CETERA, UNIVERSITY OF PANCREATIC ADENOCARCINOMA. >> DIANA CHINGOES, CANCER SURVIVOR AND PATIENT ADVOCATE IN RESEARCH IN LOS ANGELES. >> DR. KATZ, UNIVERSITY OF PITTSBURGH. >> [INAUDIBLE] FOR THE NEXT COUPLE OF DAYS, I AM AT HARVARD LAW SCHOOL AND THEN I'LL BE MOVING OVER TO UNIVERSITY OF PANCREATIC ADENOCARCINOMA SCHOOL OF MEDICINE. >> -- STATE UNIVERSITY COLLEGE OF LAW. >> KAREN JAMES WITH THE V.A. >> ANNE ANDREWS WITH NATIONAL INSTITUTE OF STANDARDS AND TECH NOTHING. >> STEF NOLG. >> STEPHANIE BRUCE, DEPARTMENT OF DEFENSE. >> JOANNE, FDA. >> JEFF -- DEPARTMENT OF ED. >> JAMES ANDERSON, STATISTICIAN WITH MERCK AND COMPANY. >> NANCY KING, WAKE FOREST SCHOOL OF MEDICINE. >> SANDY BARRY, RAND CORPORATION, BEHAVIORAL SCIENTIST. >> THANK YOU. AND JULIA, NEXT TIME I'LL REMEMBER. >> ARE THERE ANY EX-O'S IN THE AUDIENCE THAT JUST MIGHT WANT TO INTRODUCE THEMSELVES? >> RACHEL TRACY WITH THE INDIAN HEALTH SERVICE. >> AND I'M STEPHEN ROSENFELD, EXECUTIVE CHAIR, BOARD CHAIR. I THINK WE'RE READY. WE'RE A LITTLE BEHIND TIME BECAUSE WE STARTED LATE BUT WE'LL TURN TO OUR FIRST TOPIC, SUBPART A SUBCOMMITTEE REVIEW OF THE BENIGN BEHAVIORAL INTERVENTIONS IN THE NEW FINAL RULE. MICHELE. >> GOOD MORNING. OKAY. SO THANKS, EVERYBODY. , FOR BEING HERE. WE ARE GOING TO START OUR TWO-DAY MEETING GOING OVER THE DRAFT SACHRP RECOMMENDATION ON THE NEW BENIGN BEHAVIORAL INTERVENTIONS EXEMPTION. JUST A LITTLE BIT OF A RECAP HERE. WE DID GO OVER THIS AT OUR LAST MEETING AND IN THE INTERIM, THERE HAVE BEEN CALLS WITH THE SUBCOMMITTEE MEMBERS FOR THE SUBPART A AND THE HARMONIZATION SUBCOMMITTEES WHERE THOSE MEMBERS OF THOSE SUBCOMMITTEES HAVE HAD THEIR INPUT ON THIS. AND IN TERMS OF HOW WE APPROACH THIS, WHAT THE CO-CHAIRS HAVE SAID TO THE SUBCOMMITTEE MEMBERS AS WE'VE MET TO DISCUSS THIS IS THAT WHAT WE'RE COMING UP WITH IS A RECOMMENDATION, THIS GROUP HAS THE OPPORTUNITY TO OPINE ON WHAT WE'VE PUT INTO THIS IN TERMS OF THE APPROACH THAT IS RECOMMENDED FOR DEALING WITH THIS NEW EXEMPTION, BUT ULTIMATELY IT WOULD BE REFERRED ON TO OHRP AND THERE WOULD PROBABLY BE OTHER CHANGES. I SAY THAT JUST BECAUSE -- AND STEPHEN, I DON'T KNOW IF YOU WANT TO TAKE THIS OPPORTUNITY TO JUMP IN, BUT I THINK THAT WHAT I'D LIKE TO FOCUS ON IS THE APPROACH AS OPPOSED TO WORDSMITHING THE DOCUMENT, BECAUSE THERE'S ALWAYS A BETTER WAY TO REFRAME A SENTENCE AND SUBSTITUTE THIS WORD FOR THAT WORD, BUT WHAT WE WERE TRYING TO DO WITHIN THE SUBCOMMITTEES WAS FIGURE OUT HOW WE THOUGHT THIS NEW EXEMPTION SHOULD BE APPROACHED. SO STEPHEN, WOULD YOU SAY SOMETHING ON THAT? >> THANK YOU FOR THAT. I THINK THAT SHOULD BE OUR STRATEGY WITH ALL THE DOCUMENTS OF THE REVIEW. THERE ARE ALWAYS INEVITABLY WORDS THAT CAN BE BETTER, THERE ARE EVEN OCCASIONALLY MISTAKES. IT'S ALMOST CERTAINLY TRUE THAT THERE WILL BE ANOTHER ROUND OF EDITING FOR THINGS LIKE THAT BEFORE THIS IS FINALIZED, WHETHER BY SACHRP OR BY OHRP, SO WE SHOULD REALLY BE FOCUSING ON THE MESSAGE AND THE CONTENT OF THE DOCUMENTS. SO THANK YOU FOR THAT REMIND E MICHELE. >> OKAY, THANKS. SO I'M GOING -- ESPECIALLY BECAUSE WE HAVE TWO NEW PEOPLE, I'M GOING TO DO A QUICK RUNTHROUGH SNAPSHOT OF THE DOCUMENT AND THEN I WILL BRING US BACK TO THE BEGINNING OF IT. SO THE VERY BEGINNING, THIS FIRST PARAGRAPH YOU SEE HERE, EVEN FOR PEOPLE WHO HAVE BEEN PART OF THESE DISCUSSIONS IS NEW. WHAT WE WERE ASKED TO DO WAS TO ADD AN INTRODUCTORY PARAGRAPH THAT KIND OF GAVE AN INTRO INTO WHAT OUR THOUGHTS ARE ON THIS EXEMPTION, AND I JUST WANTED TO POINT OUT THAT ONE OF THE MOST IMPORTANT THINGS IN THIS IS A RESEARCH THAT DOES NOT MEET THE REQUIREMENTS FOR THIS EXEMPTION MAY BE ELIGIBLE FOR EXPEDITED REVIEW. AGAIN, WE'RE GOING TO HAVE THE OPPORTUNITY TO GO BACK THROUGH THE ENTIRE DOCUMENT. I'D JUST LIKE TO TAKE A MOMENT TO DO THIS SNAPSHOT. SO WHAT FOLLOWS AFTER THAT INTRODUCTORY PARAGRAPH ARE NINE QUESTIONS, AND THE PURPOSE OF THE NINE QUESTIONS IS TO TRY TO CREATE A FRAMEWORK THAT PEOPLE CAN USE AS THEY WORK THROUGH DIFFERENT SCENARIOS AND FIGURE OUT WHETHER THIS EXEMPTION WILL APPLY. SO IT STARTS OFF PRETTY BASICALLY WITH THE QUESTION DOES THE HUMAN SUBJECTS RESEARCH INVOLVE ONLY THE PARTICIPATION OF ADULTS? BECAUSE THAT IS ACTUALLY ONE OF THE CRITERION IN THE EXEMPTION. THE SECOND ONE, COST THE PARTICIPANT HAVE ADEQUATE DECISION-MAKING CAPACITY TO AGREE TO PARTICIPATE IN THE PROPOSED RESEARCH, AND THERE WAS A SIGNIFICANT AMOUNT OF DISCUSSION ON THIS POINT AS TO WHETHER IT WAS APPROPRIATE TO HAVE A LEGALLY AUTHORIZED REPRESENTATIVE CONSENT FOR EXEMPTION FOR THE BENIGN BEHAVIORAL EXEMPTION EXCEPTION AND JUST THE SENSE OF THE GROUP WAS THAT IT WAS NOT. THE THIRD, DOES THE NATURE OF THE RESEARCH ENABLE PROSPECTIVE AGREEMENT TO PARTICIPATION BY THE SUBJECT, AND IF SO, IS SUCH PROSPECTIVE AGREEMENT REQUIRED? THIS POINTS OUT THAT THE RELEVANT PHRASE IN THE EXEMPTION IS NOT CONSENT BUT PROSPECTIVE AGREEMENT. NUMBER FOUR, IF THE RESEARCH INVOLVES DECEIVING THE SUBJECTS, DOES THE RESEARCH INVOLVE PROSPECTIVE AGREEMENT BY THE SUBJECT TO THE PLANNED DECEPTION? FIVE, IS THE RESEARCH INTERVENTION LIMITED TO PROCEDURES INVOLVING A, B AND C. THIS WAS A VERY IMPORTANT -- THIS EP CAPS ENCAPSULATES A VERY IMPORTANT PART OF OUR PREVIOUS DISCUSSION WHICH IS WHEN YOU'RE TALKING ABOUT SOMETHING THAT IS A BENIGN BEHAVIORAL INTERVENTION, HOW DO YOU DEAL WITH THE FACT THAT THERE MAY WELL BE SOME PHYSICAL ACTIVITY AS PART OF THAT BENIGN BEHAVIORAL INTERVENTION, AND HOW DEEPLY DO WE GET ENTWINED IN EVALUATING THAT PHYSICAL ACTIVITY. AND ONCE AGAIN, WE'LL GO BACK THROUGH THESE, BUT JUST TRYING TO POINT OUT THE SALIENT POINTS. SIX, DOES THE HUMAN SUBJECT RESEARCH INVOLVE MEANS OF COLLECTING DATA LIMITED TO VERBAL OR WRITTEN RESPONSES, DATA ENTRY OR OBSERVATION OF THE SUBJECT BECAUSE THE EXEMPTION IS VERY CLEAR THAT THERE'S VERY SPECIFIC TYPES OF DATA COLLECTION. SEVEN, DOES THE INTERVENTION OR METHODS USED TO COLLECT DATA INTRODUCE RISKS OF HARM, PHYSICAL OR EMOTIONAL DISCOMFORT, OFFENSE OR EMBARRASSMENT? EIGHT, IS THE RESEARCH BRIEF IN DURATION? SO THIS HAS BEEN ONE OF THE MOST DIFFICULT ISSUES TO ADDRESS. BOTH WITHIN THE LAST MAIN SACHRP MEETING AND WITH RESPECT TO THE INTERVENING SUBCOMMITTEE MEETINGS. AT THE LAST SACHRP MEETING, THE COMMITTEE ADDED THE WORDS UNDER THE DESCRIPTION AT THE BOTTOM "BRIEF IS INTENDED TO MEAN A FEW MINUTES TO A FEW HOURS." THE COMMITTEE ADDED THE WORDS "AND DOES NOT LEAD TO ANY FATIGUE OR INCONVENIENCE," AND I JUST WANT TO NOTE THAT BECAUSE THE SUBCOMMITTEE MEMBERS TOOK THAT OUT AFTER MUCH DISCUSSION OF FATIGUE AND INCONVENIENCE. AND NANCY, I THINK YOU WERE ON SOME OF THOSE SUBCOMMITTEE CALLS, SO IT'S GREAT, AM I RIGHT? IT'S GREAT TO HAVE YOU HERE BECAUSE YOU ARE ALSO ANOTHER PERSON WHO WAS PRIVY TO ALL THESE DIFFERENT CONVERSATIONS. NINE, IS AT LEAST ONE OF THE FOLLOWING -- SO ANYWAY, THIS BRIEF IN DURATION ONE IS VERY CRITICAL TO THIS DOCUMENT, AND I THINK IT MAY WELL BE THE PLACE WHERE WE SPEND A GOOD AMOUNT OF OUR TIME. NINE, IS AT LEAST ONE OF THE FOLLOWING CONDITIONS REGARDING PRIVACY PROTECTIONS MET? SO THOSE ARE THE NINE QUESTIONS. WHAT FOLLOWS FROM THOSE NINE QUESTIONS ARE SEVERAL EXAMPLES, AND THEN AFTER EACH EXAMPLE IN THE GRAY SHADED AREA IS WHAT WE CAME UP WITH AS OUR ANALYSIS OF WHETHER THE EXAMPLE MEETS EXEMPTION OR NOT, AND IF NOT, WHY NOT. AND I DON'T RECALL THAT WE ACTUALLY WENT THROUGH THE EXAMPLES THE LAST TIME WE WERE HERE AS A GROUP, BUT I THINK THIS WOULD BE AN OPPORTUNE TIME TO DO THAT WHEN WE'RE DONE GOING THROUGH THE NINE QUESTIONS. SO THAT'S A QUICK OVERVIEW OF THE DOCUMENT THAT WE'RE GOING TO GO OVER TODAY. AND I'M THINKING THAT WE'LL GO BACK TO THE BEGINNING. DOES THAT SOUND OKAY, STEPHEN? DO YOU WANT TO ADD ANYTHING BEFORE I GET STARTED? >> I HOPE THAT THE SUBCOMMITTEE DELIBERATIONS SORT OF ARE CONSISTENT WITH THIS. YOU KNOW, WHEN WE SPENT SO MUCH TIME ON A LOT OF THESE DIFFERENT CRITERIA LAST TIME, ONE OF THE BENCHMARKS WE ENDED UP USING WAS THE REMINDER THAT THIS WAS AN EXEMPTION CATEGORY, SO IF YOU MAKE THIS, THERE'S NO FURTHER OVERSIGHT OR REVIEW. AT LEAST FROM THE IRB APPARATUS. SO THAT IT HAS TO BE FAIRLY CUT AND DRIED. SO IN GENERAL, WE DID BRAINSTORM AT THE LAST MEETING A LOT OF THINGS THAT WERE BEHAVIORAL INTERVENTIONS THAT WE ALL FELT WOULD NOT BENEFIT FROM IRB REVIEW, BUT TO MAKE THE LANGUAGE LANGUAGE, I THINK PART OF THE BRIEF DURATION ISSUE WATION TO WAS TO MAKE THE LANGUAGE INCLUDE EVERYTHING THAT WE MIGHT WANT TO, REALLY SACRIFICED CLARITY AND WE FELT IT WAS BETTER TO HAVE IT -- BECAUSE AGAIN, IT'S AN EXEMPTION, AND ONCE YOU MEET IT, YOU'RE DONE. THAT IT BE NARROW, AND AGAIN AS THE NEW LANGUAGE SAYS, THE COST OF THAT, EVEN IF THERE'S SOMETHING THAT WE ALL AGREE DOES NOT PRESENT RISK TO PARTICIPANTS, THE WORST THING THAT HAPPENS IS THAT IT GOES FOR EXPEDITED REVIEW, WHICH IF YOU NOW RECALL UNDER THE FINAL RULE DOESN'T REQUIRE CONTINUING REVIEW, SO THE BURDEN IS ACTUALLY NOT HIGH, EVEN IF YOU MISS THIS. BUT I WOULD JUST LIKE, UNLESS YOU DISAGREE, AND THEN WE SHOULD DISCUSS IT, BUT TO COME AT THE DISCUSSION OF THIS WITH THE BIAS AGAIN THAT THIS IS AN EXEMPTION, IT HAS TO BE CLEAR, AND IT'S BETTER TO LEAVE SOME THINGS OUT THAT ARE MINIMAL RISK THAT BE TO THAN TO OPEN THE DOOR FOR THE REALISTIC POSSIBILITY THAT SIGNIFICANT RISK ACTIVITIES WOULD BE INCLUDED. >> THANKS. SO I'M GOING TO TAKE US TO THIS FIRST PARAGRAPH. SO THE IDEA WAS THAT WE NEEDED A FIRST INTRODUCTORY PARAGRAPH THAT COVERED WHAT ARE THE CRITICAL ISSUES. IT BASICALLY RESTATES A LOT OF WHAT'S IN THE EXEMPTION, AND WHAT IS IN ADDITION IS THAT IT MAY WELL BE ELIGIBLE FOR EXPEDITED REVIEW. ALSO WITH THE HOPE THAT WE CAN AVOID WORDSMITHING BECAUSE THIS WILL GO THROUGH ANOTHER ROUND IF NOT MORE OF EDITING, I'D LIKE TO OPEN THE DISCUSSION WITH THE QUESTION IS THERE ANYTHING ELSE THAT THE GROUP FEELS SHOULD BE INCLUDED IN AN INTRODUCTORY PARAGRAPH TO THE USE OF THIS NEW EXEMPTION. YES. >> [INAUDIBLE] >> SO THAT'S IN THE EXEMPTION, RIGHT. SO THE EXEMPTION SAYS PROSPECTIVE ADPREEMENT. AGREEMENT. IS YOUR COMMENT THAT YOU THINK WE SHOULD ADD SOMETHING IN THE INTRODUCTORY PARAGRAPH THAT SAYS IT'S IMPORTANT TO NOTE THAT THE EXEMPTION DISCUSSES A PROSPECTIVE AGREEMENT AS OPPOSED TO CONSENT? >> THE LANGUAGE WE TYPICALLY USE IS INFORMED CONSENT AND IT SORT OF INTRODUCES THE QUESTION OF WHETHER AGREEMENT MEANS SOMETHING DIFFERENT, LESS EXTENSIVE OR SOMETHING THAT DOESN'T -- THAT ISN'T THE SAME AS INFORMED CONSENT. THIS IS A WORLD WHERE INFORMED CONSENT IS WHAT WE SAY. >> SO WE HAVE IN HERE, IN THE THIRD LINE IT SAYS SUBJECT AUTONOMY IS RESPECTED -- WE COULD ADD THERE A COMMENT THAT IT SHOULD BE NOTED THAT THIS IS NOT AN EXPECTATION THAT THERE WOULD BE INFORMED CONSENT, THAT THIS IS SOMETHING DIFFERENT THAN INFORMED CONSENT. >> IS IT SOMETHING DIFFERENT THAN INFORMED CONSENT? >> YES. ALTHOUGH COLLEAGUES FROM OHRP CAN OPINE HERE. MY INTERPRETATION IS THAT PROSPECTIVE AGREEMENT IS NOT THE SAME AS INFORMED CONSENT. >> AND WHAT'S DIFFERENT ABOUT IT? IN WHAT WAY? HOW DO YOU DISTINGUISH PERSPECTIVE AGREEMENT FROM INFORMED CONSENT? >> I THINK IT'S JUST THAT YOU DON'T HAVE TO GO THROUGH THE REQUIRED ELEMENTS, ADDITIONAL ELEMENTS IN THE REGULATIONS, SO FOR PROSPECTIVE AGREEMENT, YOU'RE ASKING SOMEONE, THEY SAY YES, BUT YOU DON'T HAVE TO GO THROUGH EACH ONE OF THOSE ELEMENTS AND HAVE THEM SIGN AND DOCUMENT THAT THEY ARE CONSENTING TO PARTICIPATION. IT'S IN QUESTION THREE OF THIS DOCUMENT. >> I'LL MAKE A NOTE ABOUT WHETHER IT SHOULD BE SOMETHING POINTED OUT IN THE INTRODUCTORY PARAGRAPH. SO THAT SAID, I WILL MOVE US ALONG. SO THE FIRST QUESTION I THINK IS PRETTY STRAIGHTFORWARD, DOES HUMAN SUBJECTS RESEARCH INVOLVE ONLY THE PART PAITION OF ADULTS? IF NO, IT'S NOT EXEMPT. TWO, DOES THE PART PANT HAVE ADEQUATE DECISION-MAKING CAPACITY TO PARTICIPATE IN THE PROPOSED RESEARCH? AND ONCE AGAIN, THIS WAS THE SUBJECT OF MUCH DISCUSSION ABOUT WHETHER YOU COULD HAVE A LEGALLY AUTHORIZED REPRESENTATIVE CONSENT FOR PARTICIPATION IN THIS TYPE OF EXEMPT RESEARCH AND THE CONSENSUS OF THE GROUP WAS AS REFLECTED IN THE LAST SENTENCE, "RESEARCH REQUIRING DECISION-MAKE ON BEHALF OF THE PARTICIPANT BY A LEGALLY AUTHORIZED REPRESETATIVE WOULD NOT QUALIFY FOR THE EXEMPTION." SO DOES THE GROUP STILL -- IS THE GROUP STILL OKAY WITH THAT? YES. >> I'D LIKE TO GO BACK TO NUMBER ONE. >> SURE. >> DO WE WANT TO DEFINE "ADULT"? >> THERE'S A DEFINITION IN THE MAIN REGULATIONS OF ADULT IN THE SENSE THAT YOU REFERENCE APPLICABLE STATE LAW. I THINK THAT FOR THE PURPOSE OF WRITING GUIDANCE BY THIS GROUP, WE NEED TO BE CAREFUL ABOUT REFERRING TO THINGS THAT ARE ALREADY IN THE OTHER DOCUMENTS OR THIS COULD BE CONSIDERABLY LONGER. JUST MY THOUGHT. OTHERS CAN WEIGH IN. >> JUST A FOOTNOTE TO THAT CONVERSATION. BASICALLY ON COLLEGE CAMPUSES, YOU HAVE EARLY ADMISSIONS FOR HIGH SCHOOL STUDENTS AND VARIOUS OTHER OVERLAPS SO WHEN YOU'RE CONDUCTING A STUDY ON A COLLEGE CAMPUS, FOR EXAMPLE, THIS COULD RAISE QUESTIONS ABOUT HOW TO DO IT. >> IT COULD. >> I'M NOT SURE IT FALLS DIRECTLY UNDER QUESTION NUMBER ONE, BUT WHEN I READ THROUGH THIS AND AS WE'RE DISCUSSING IT NOW, I WAS THINKING ABOUT PRISONERS, AND I'M NOT SURE THAT ANY OF THE QUESTIONS ADDRESS -- BECAUSE THAT WOULD BE A POPULATION I WOULD THINK FOR SOME RESEARCH IS RIPE FOR BEHAVIORAL INTERVENTION RESEARCH. AND DO WE NEED SOMETHING ABOUT THAT IN HERE OR NO. >> MY APOLOGIES IF THIS WAS ADDRESSED PREVIOUSLY. >> NO, IT WASN'T ADDRESSED PREVIOUSLY. I NEED HELP HERE ON WHETHER THIS POPULATION WAS SPECIFICALLY EXCLUDED FROM USE OF THIS EXEMPTION. I DON'T RECALL. JERRY? JULIA? >> WELL, IN THE NEW RULE, THE EXEMPTIONS DON'T APPLY UNLESS THE STUDY IS EXAMINING A DIFFERENT POPULATION AND IS ONLY INCIDENTAL INCLUDING PRISONERS. SO I GUESS POTENTIALLY MAYBE -- >> IT COULD. YEAH. >> IT'S POSSIBLE. >> IT'S A GOOD POINT. I GUESS WHAT I'M THINKING IS THAT IT'S A BROADER ISSUE THAN PRISONERS. IT'S AN ISSUE OF DIFFERENT TYPES OF VULNERABLE POPULATIONS AS WELL. SO LET'S GO BACK TO THE ISSUE OF THE ADULTS, THOUGH, FIRST, JUST BECAUSE THAT'S WHERE I CAN GET MY HANDS AROUND IT. I'D ASK THE GROUP TO WEIGH IN ON THIS. I THINK THAT THERE IS A REFERENCE IN THE MAIN REGULATIONS TO ADULTS AND MINORS AND STATE LAWS AND SO ON AND SO FORTH, AND I'M JUST A LITTLE WORRIED ABOUT SORT OF ADDING ALL THOSE THINGS INTO THIS BECAUSE WE COULD END UP WITH A PRETTY DENSE DOCUMENT. DID YOU HAVE A COMMENT? >> I'M WITH YOU. LEAVE IT AS ADULTS. >> IS THAT OKAY? WE'LL LEAVE THAT AS ADULTS. SO LET ME THROW OUT -- HOLLY? >> I WAS JUST GOING TO BRAINSTORM ABOUT A SUGGESTION WHICH IS I DON'T KNOW THAT WE NEED TO MENTION PRISONERS NECESSARILY BY NAME AS A VULNERABLE GROUP, BUT IT COULD GO IN THAT INTRODUCTORY PARAGRAPH ALONG WITH WHAT STREEFN WAS SAYING ABOUT STEPHEN WAS SAYING ABOUT SORT OF THE GENESIS OF THIS GUIDANCE, NOT TRYING TO INCLUDE TOO MANY THINGS, SO WE MIGHT TAKE A PAGE OUT OF THE EXPEDITED GUIDANCE WHICH BASICALLY SAYS THAT THERE'S AN INDEPENDENT RESPONSIBILITY TO MAKE SURE THIS REALLY IS MINIMAL RISK AND THAT VULNERABLE POPULATION ARE NOT INCLUDED IN THIS EXEMPTION, SOMETHING ALONG THOSE LINES. >> DOES THIS IS ONLY APPLIES TO SUBPART A BUT IF YOU HAD TO INVOKE THE OTHER SUBPARTS, WOULD THIS STILL APPLY? >> I THOUGHT AS JULIA WAS EXPLAINING THAT THAT WAS FOR THE PRISONER SUBPART, THE EXEMPTIONS DO NOT APPLY, RIGHT? >> NO, PER THE REVISED RULE, THERE IS A VERY NARROW EXEMPTION WHERE IT'S POSSIBLE THAT THE EXEMPTIONS COULD APPLY TO SUBPART C. IF THE STUDY IS NOT TARGETING PRISONERS, PER SE, BUT PRISONERS ARE ONLY INCIDENTAL SUBJECT IN THE POPULATION. >> SO MAYBE THAT'S WHAT WE INCLUDE IN THE INTRODUCTORY PARAGRAPH IS REFERENCE TO THAT. HOW'S THAT? >> I GUESS WHAT I THOUGHT IT WAS A BROADER COMMENT THAT PRISONERS WAS ONE TYPE OF VULNERABILITY, BUT WE MIGHT WANT TO MAKE A BROADER COMMENT IN THE INTRODUCTORY PARAGRAPH THAT'S SUGGESTIVE THAT THIS EXEMPTION IS NOT APPROPRIATE FOR VULNERABLE GROUPS? >> I THINK IF WE'RE GOING TO INCLUDE -- STILL INCLUDE PREGNANT WOMEN AS A VULNERABLE POPULATION, I DON'T SEE THEM AS BEING PARTICULARLY AT RISK, I DO WORRY ABOUT THE PRISONERS, THOUGH. >> YEAH, WHAT I'M HEARING IS THE QUESTION OF -- IN TERMS OF ADDING ADDITIONAL QUESTION, WHAT POPULATIONS IN TERMS OF VULNERABLE POPULATIONS DOES THIS APPLY TO? THAT IS THE QUESTION I'M HEARING. TO BE ADDED AS AN ADDITIONAL QUESTION. WHICH ISN'T PERTINENT TO THE PEOPLE READING THIS GUIDANCE. WHAT POPULATION SHOULD I NOT CONSIDER JUST AS WE DO IN OUR CURRENT COMMON RULE. SO THAT WOULD BE THE SUGGESTION I WOULD GO WITH. >> SO THE STAT STATUTORILY DEFINED SUBPARTS ARE DISCUSSED EARLIER IN THE EXEMPTIONS. WHAT ABOUT LANGUAGE JUST SAYING THAT OTHER CRITERIA, EMBARRASSING, COMPROMISING, ALL OF OTHER THINGS THAT COME UNDER THE DEFINITION OF BENIGN BEHAVIORAL INTERVENTION THAT THE CHARACTERISTICS OF THE POPULATION BEING STUDIED SHOULD BE ONE OF THE THINGS BEING TAKEN INTO ACCOUNT TO MAKE THAT DETERMINATION? OR IS THAT JUST OBVIOUS? >> CHARACTERISTICS OF THE GREUM? I LIKE THE IDEA OF ADDING ANOTHER QUESTION. BECAUSE I THINK THIS IS AN IMPORTANT POINT, IT'S INTERESTING HOW WITH ALL THE DISCUSSION WE'VE HAD SO FAR, WE ACTUALLY HAVEN'T FOCUSED ON IT UNTIL NOW, THAT'S A GREAT QUESTION. EVEN, STEPHEN, WITH YOUR COMMENT CONSIDERING THE CHARACTERISTICS OF THE GROUP INVOLVED, THAT WOULD STILL BE RELEVANT TO HAVING A NEW QUESTION. SO THE FIRST QUESTION IS DOES IT INVOLVE ADULTS? YES. SECOND QUESTION, WHAT POPULATION IS TARGETED TO BE INCLUDED IN THE USE OF THIS EXEMPTION? AND THEN WE COULD ADD A REMINDER THERE ABOUT THE GENERAL LANGUAGE THAT IT SHOULDN'T TARGET, THAT THEY SHOULD BE INCIDENTAL, AND AS USUAL, THERE SHOULD BE CONSIDERATION TO THE RISK -- TO THE CHARACTERISTICS OF THE POPULATION THAT'S UNDER STUDY OR SOMETHING LIKE THAT. IF THAT SOUNDS LIKE IT'S WHERE THE GROUP IS HEADED, I'LL MAKE A NOTE AND I CAN WRITE THAT UP AND THEN TRADITIONALLY WHAT WE DO IS WE'LL TAKE COMMENTS HERE AND BRING A DOCUMENT BACK WITH SOME OF THE REVISIONS. DOES THAT SOUND LIKE AN OKAY APPROACH? >> SO JUST A COMMENT, AND I DON'T KNOW HOW OTHERS FEEL ABOUT THIS, I THINK WE SHOULD BE CAUTIOUS ABOUT BEING TOO LIMITING BECAUSE WHAT IS A VULNERABLE POPULATION OFTEN CHANGES WITH ONE'S PERSPECTIVE. SO I DON'T KNOW IF YOU WANT TO SAY THAT SUCH POPULATIONS WOULD ONLY BE INCIDENTALLY INVOLVEED. I THINK WHATEVER POPULATION YOU INVOLVE, IT HAS TO -- THAT SHOULD BE TAKEN INTO ACCOUNT, THEY HAVE TO HAVE PROSPECTIVE AGREEMENT, IT CAN'T BE IN ANY WAY DAMAGING TO THEM. IT SEEMS TO ME THOSE CRITERIA MAY APPLY DIFFERENTLY TO DIFFERENT POPULATIONS, BUT IF YOU SATISFY THEM, IN GENERAL THE EXEMPTION SHOULD APPLY, BUT I DON'T KNOW, HOW DO OTHERS FEEL ABOUT THAT? >> WOULD THIS MEAN THAT FOR PRISONER POPULATIONS, WE WOULDN'T NEED TO HAVE APPROVAL BY A PRISONER REPRESENTATIVE? >> SO PRISONER POPULATIONS, AS JULIA POINTED OUT, THEY'RE EXPLICITLY DEALT WITH THE INCIDENTAL LANGUAGE BUT IT'S SILENT TO THE PRISONER REPRESENTATIVE PEASE. SINCE IT DOESN'T GO TO AN IRB, THOUGH, BECAUSE IT'S AN EXEMPTION, I WOULD ASSUME NOT. >> SO YOU WOULD BE COMFORTABLE WITH HAVING PRISONERS EXEMPTED IN THIS WAY? >> [INAUDIBLE] >> SO, LIKE, SOMEONE WHO'S AT HOME WITH A -- WHO WOULD BE A PRISONER WHO WOULD BE INCIDENTALLY INCLUDED? SOMEONE WHO'S AT HOME WITH SOME KIND OF A DEVICE AROUND THEIR ANKLE? I MEAN, IT'S HARD TO IMAGINE WHO WOULD BE. >> I THINK THE NOTION WAS THAT YOUR TARGET GROUP OF SUBJECTS WOULD BE A GROUP THAT, BY DEFINITION, ISN'T REALLY AGAIN -- YOU'RE NOT DESCRIBING AS PRISONERS BUT IT COULD BE THAT SOME ACTUAL PRISONERS MEET THAT STANDARD. SO YOU COULD BE SAYING EVERYBODY WHO HAS THIS INCREDIBLY OBSCURE DISEASES DISEASE THAT'S IN THE RECORDS OF A PARTICULAR HOSPITAL, WITH THE THINKING THAT ASSUMING IT'S NOT INCREDIBLY LIKELY THAT ONLY PRISONERS ARE THE PEOPLE WHO GET THIS DISEASE, YOU WOULD PICK UP NIEP TI 8% OF PEOPLE WHO WERE OUTSIDE AND NOT IN PRISONS, BUT THERE COULD BE A FEW PRISONERS IN YOUR DATABASE AND THIS WOULD NOT PREVENT THE WHOLE INTENT OF THE NEW RULE, WAS TO ALLOW THOSE PRISONER, EVEN THOUGH THEY ARE ACTUALLY PRISONERS, TO BE EXEMPTED. >> WITHOUT MAKING PRISONER FINDINGS. >> YOU WOULDN'T HAVE TO BECAUSE YOU'RE NOT GOING THROUGH ANY IRB. AGAIN, IT'S EXEMPT. >> SO WE HAVE A COUPLE EXAMPLES AT THE END, AND IF YOU -- ONE OF OUR EXAMPLE HAS TO DO WITH PLAYING MUSIC. IF YOU HAD AN ICU UNIT OR YOU HAD MUSIC BEING PLAYED IN A HOSPITAL, YOU ACTUALLY -- WHO KNOWS WHO THOSE PEOPLE ARE IN THE HOSPITAL. YOU COULD HAVE SOMEBODY THAT'S A PRISONER, YOU COULD HAVE PEOPLE WITH VARYING CHARACTERISTICS. SO I THINK THAT'S A KIND OF SITUATION WHERE YOU MIGHT END UP WITH SOMEONE WHO'S A PRISONER, AND LIKE EVERYBODY SAID, YOU WOULDN'T HAVE THE PRISONER REGULATORY DETERMINATIONS MADE, YOU WOULDN'T HAVE A PRISONER REPRESENTATIVE BECAUSE THE WHOLE POINT OF THIS IS THAT IT'S SO BENIGN THAT YOU DON'T NEED THAT ADDITIONAL PROTECTION OF INSTITUTIONAL REVIEW BOARD OVERSIGHT. SO I GUESS THINKING ABOUT IT IN THAT WAY TOO, IF IT'S SO BENIGN AND YOU DO HAVE SOMEBODY WHO'S A PRISONER, WHAT'S THE HARM THAT WE'RE WORRIED ABOUT BY HAVING THAT PERSON INCLUDED IN THIS VERY BENIGN BEHAVIORAL RESEARCH. >> I WOULD POINT OUT, TOO, THAT THE LANGUAGE THAT DESCRIBES THAT PRISONERS BE INCIDENTAL APPLIES TO ALL THE EXEMPTIONS. IT'S NOT SPECIFICALLY TO THIS ONE. AND I THINK WE REALLY HAVE TO BEND OVER BACKWARDS TO THINK OF EXAMPLES WHERE THEY'RE LIKELY TO BE PRISONERS IN BEHAVIORAL INTERVENTIONS. >> SO HOW ABOUT -- LET ME SUGGEST THAT -- I WILL ADD A SECOND QUESTION ANDLY WORK ON THE LANGUAGE AND THEN I BELIEVE THERE WILL BE AN OPPORTUNITY, JULIA, TO COME BACK WITH THE CHANGES SO I DON'T HAVE TO DO THIS RIGHT HERE. SO NOW THAT WE GOT PAST 1, THERE WILL BE A NEW 2. 3 IS THE -- GOES TO THE QUESTION OF WHETHER A LEGALLY AUTHORIZED REPRESENTATIVE SHOULD BE ABLE TO MAKE A DECISION ABOUT SOMEONE'S PARTICIPATION IN THIS EXEMPT RESEARCH. SO DOES ANYBODY HAVE ANY OBJECTION TO KEEPING THIS THE WAY IT IS? AGAIN, THE REMINDER IS THAT IF IT DOESN'T MEET THIS, IT CAN JUST BE EXPEDITED. SO THIS NUMBER 3 AND AGAIN THE NUMBERS WILL CHANGE, DOES THE NATURE OF THE RESEARCH ENABLE PROSPECTIVE AGREEMENT TO PARTICIPATION BY THE SUBJECT AND, IF SO, IS SUCH PROSPECTIVE AGREEMENT REQUIRED. SO THIS GOES TO THE QUESTION THAT WAS RAISED ABOUT IS PROSPECTIVE AGREEMENT CONSENT? WHAT WE HAVE IN THE EXEMPTION IS THE PHRASE PROSPECTIVE AGREEMENT, AND SO WHAT WE TRY TO DO IS FIGURE OUT WHAT THAT SHOULD MEAN. SO THE LANGUAGE OF THE EXEMPTION THAT REQUIRES SUBJECTS TO PROSPECTIVELY AGREE TO THE SPECIFIC INTERVENTION AND THE INFORMATION COLLECTION. THIS MEANS THAT ONLY RESEARCH IN WHICH THE HUMAN SUBJECT IS A KNOWING PARTICIPANT IN RESEARCH WOULD QUALIFY FOR THE EXEMPTION, PROSPECTIVE AGREEMENT MUST BE MEANINGFUL, BUT IT IS NOT THE SAME AS A REQUIREMENT FOR EXPLICIT CONSENT BECAUSE FOR EXAMPLE, INDIVIDUALS WERE SIMPLY MADE AWARE THAT RESEARCH DATA WILL BE COLLECTED AS THEY COMPLETE A COMPUTER TASK MAY BE UNDERSTOOD AS HAVING AGREED TO PARTICIPATE. RESEARCH FOR WHICH PROSPECTIVE AGREEMENT IS NOT POSSIBLE WOULD NOT BE ELIGIBLE FOR EXEMPTION. FOR EXAMPLE, RESEARCH INVOLVING THE VIDEOTAPING OF PEDESTRIANS' BEHAVIOR WHEN THE TIMING OF A PUBLIC WALK/DON'T WALK IS MANIPULATED WOULD NOT BE EXEMPT UNDER THIS CATEGORY UNLESS THEY AGREED IN ADVANCE TO PARTICIPATE. SO ONCE AGAIN, THE CAVEAT IS THAT IT HAS TO BE DENINE,BENIGN, CAN'T BE BRIEF IN DURATION, CAN'T BE OFFENSIVE, EMBARRASSING, IT HAS TO BE HARMLESS, CAN'T BE PAINFUL. SO IT'S WITHIN THAT CONTEXT THAT WE FIGURE OUT HOW TO DESCRIBE PROSPECTIVE AGREEMENT. STEPHEN LOOKS LIKE HE'S REACHING FOR HIS MIC. >> I WAS JUST GOING TO ASK ABOUT A WORD WHICH I KNOW WE WEREN'T SUPPOSED TO DO. >> I'M NOT LISTENING. [LAUGHTER] FLASH >> IF IT'S WORTHWHILE PUTTING VOLUNTARY IN FRONT OF A COMPUTER TASK. THERE ARE LOTS OF THINGS WE DO WITH COMPUTE IRES AND IF YOU'RE JUST TOLD DATA IS GOING TO BE COLLECTED, THAT'S NOT THE SAME AS PROSPECTIVE AGREEMENTS. >> SURE. YOU'RE THE EXECUTIVE CHAIR. >> I WAS GOING TO MAKE THE SAME POINT, THAT SOMEHOW VOLUNTARY SEEMS TO BE MISSING. >> THAT'S GREAT. SO AS THEY VOLUNTARILY COMPLETE& A COMPUTER TASK. GOOD. ALL RIGHT. OKAY. >> 4, IF THE RESEARCH INVOLVES DECEIVING THE SUBJECTS, THE EXEMPTION PERMITS RESEARCH INVOLVING DECEPTION ONLY WHEN THE SUBJECT AGREES TO PARTICIPATE FOLLOWING DISCLOSURE OF THE FACT THAT HE OR SHE WITH WILL BE UNAWARE OR MISLED REGARDING THE NATURE OR PURPOSE OF THE RESEARCH. SO YOU CAN GO DOWN A RABBIT HOLE ABOUT ALL DIFFERENT KINDS OF RESEARCH THAT COULD REASONABLY INCLUDE DECEPTION WHERE YOU DON'T WANT TO TELL PEOPLE, BUT AGAIN IF IT DOESN'T FIT THIS EXEMPTION T CAN LIKELY BE EXPEDITED. SO WHAT THIS IS AGAIN REACHING OR THE TYPES OF RESEARCH THAT ARE SO BENIGN THAT IT DOESN'T NEED ANY TYPE OF IRB OVERSIGHT. HOLLY? >> IS THERE SOME EXPECTATION THAT YOU DISCLOSE THE TYPE OF DECEPTION AFTER PARTICIPATION IS OVER SIMILAR TO THE WAIVER OF CONSENT? I DON'T THINK WE TALKED ABOUT THAT YET. A DEBRIEF. I DON'T KNOW IF IT'S ESSENTIAL BECAUSE IT'S SO BENIGN, BUT I THINK PEOPLE WOULD AT LEAST BE CURIOUS, RIGHT, TO KNOW HOW THEY WERE DECEIVED. I'M ON THE FENCE ABOUT WHETHER IT SHOULD BE REQUIRED AS PART OF THE EXEMPTION THAT YOU INCLUDE THE DEBRIEF? >> COULD BE A RECOMMENDATION. COULD BE A SUGGESTION. >> I THINK THE LANGUAGE IS DEBRIEF WHERE APPROPRIATE. WHICH IS NOT -- >> HOW ABOUT IF I ADD A LINE AFTERWARDS THAT TALKS ABOUT RESEARCHERS MIGHT CONSIDER DEBRIEFING AFTERWARDS AS APPROPRIATE? OKAY. IS THE RESEARCH INTERVENTION LIMITED TO PROCEDURES INVOLVING COMMUNICATION OR INTERPERSONAL CONTACT, THE PERFORMANCE OF A COGNITIVE INTELLECTUAL, EDUCATIONAL BEHAVIORAL TASK OR MANIPULATION OF THE SUBJECT'S PHYSICAL, SENSORY OR EMOTIONAL ENVIRONMENT. SO THIS WAS -- THIS WAS A SUBJECT OF MUCH DISCUSSION. THE TERM BEHAVIORAL INTERVENTION IS USED IN THE LANGUAGE OF THE REGULATIONS TO DEFINE RESEARCH PROCEDURES THAT ARE EMPLOYED IN THE STUDY OF PSYCHOLOGICAL STATES AND PROCESSES, COGNITION, IDEAS AND ATTITUDES OR BEHAVIOR, AND DO NOT INCLUDE PHYSICAL BODILY TASKS OR PHYSICAL MANIPULATION. RANGE OF MOTION ACTIVITIES, PHYSICAL EXERCISE. THIS IS THE CRITICAL SENTENCE: UNLESS THESE ARE MINOR ACTIVITIES THAT ARE INCIDENTAL TO THE BEHAVIORAL INTERVENTION AND DO NOT INCREASE RISK. SO WE STARTED TO GO OFF A CLIFF HERE, TALKING ABOUT THE NAVY SEALS PARACHUTING OUT OF PLANES, AND LISTENING TO MUSIC WHILE THEY WERE DOING THAT OR WHATEVER OUR EXAMPLES WERE, BUT THE GROUP OUTSIDE OF THE MAIN MEETING I THINK WAS VERY COMFORTABLE WITH THE LANGUAGE THAT'S IN HERE RIGHT NOW. SO LET ME JUST CONTINUE, THEN I'LL GET TO YOU, NANCY. FOR EXAMPLE, MANIPULATING A KEYBOARD, WHICH IS A PHYSICAL TASK, DOING A PUZZLE, WALKING WHILE LISTENING TO MUSIC, PHYSICAL ACTIVITIES, PHYSICAL ACTIVITIES THAT COULD BE CONSIDERED MINOR ACTIVITIES THAT ARE TAKING PLACE INCIDENTAL TO THE BE NIEP BEHAVIORAL INTERVENTION, PHYSICAL ACTIVE INTERVENTIONS THAT ARE PHYSICALLY INVASIVE, WHERE THOSE THAT COULD BE HARMFUL OR PAINFUL WOULD NOT MEET THE EXEMPTION. NANCY? >> THIS IS ABOUT A WORD BUT IT ISN'T WORDSMITHING. >> SURE. >> I THINK IT SHOULD BE INCIDENT TO RATHER THAN INCIDENTAL TO, AND THAT SORT OF MADE CLEAR THE -- THE DISTINCTION IS MADE CLEAR BY THE DISCUSSION WE JUST HAD ABOUT PRISONER SUBJECTS WHO WERE INCIDENTAL. >> OK. GOT IT. THEN IT GOES ON, BEHAVIORAL INTERVENTIONS ARE NOT PHYSICALLY INVASIVE WHEN THEY DO NOT INVOLVE THE ADMINISTRATION OF INSTRUMENTS, SUBSTANCES OF ENERGY, ALTERATIONS IN THE SUBJECT'S PHYSICAL OR SENSORY ENVIRONMENT MAY BE CONSIDERED BEHAVIORAL INTERVENTIONS FOR THE PURPOSE OF THIS EXEMPTION, SUCH INTERVENTIONS MAY NOT BE HARMFUL, PAINFUL, DISTRESSING, COLD NOISE OR LIGHT. I JUST THINK THAT WHAT WE'RE TRYING TO DO IS COME UP WITH AN APPROACH THAT WILL MAKE SENSE TO PEOPLE WHO WERE GOING TO HAVE TO THINK ABOUT HOW DOES THIS GET APPLIED. AND I PERSONALLY THOUGHT THAT THIS WAS A NICE WAY OF DESCRIBING IT, ESPECIALLY GIVEN ALL THE DIFFERENT SITUATIONS WE WERE ABLE TO CONJURE UP HERE IN OUR VARIOUS MEETINGS. ARE THERE ANY OTHER COMMENTS OR THOUGHTS ABOUT THIS? OKAY. VERY SATISFYING FOR ME TO HEAR. DOES THE HUMAN SUBJECTS RESEARCH INVOLVE MEANS OF COLLECTING DATA LIMITED TO VERBAL OR WRITTEN RESPONSES, DATA ENTRY BY THE SUBJECT, OBSERVATION OF THE SUBJECT. SO HERE THERE WAS SOME DISCUSSION ABOUT THE DATA ENTRY AND WHETHER IT HAD TO BE BY THE SUBJECT, SO IF THE DEVICE RECORDED IT, WAS THAT ADEQUATE DATA -- WAS THAT DATA ENTRY THAT WOULD MEET THE EXEMPTION? AND IT WON'T. SO THE PARAGRAPH SAYS THIS CATEGORY DEFINES A NARROW SET OF THE ALLOWABLE MEANS BY WHICH DATA CAN BE COLLECTED, EVEN VERY LOW RISK PHYSICAL PROCEDURES SUCH AS THE APPLICATION OF SENSORS TO THE BODY, BLOOD PRESSURE MONITORING, MINIMALLY INVASIVE PROCEDURE, BLOOD DRAWING IN THE COLLECTION OF BODILY FLUIDS WOULD NOT BE CONSISTENT WITH THE LANGUAGE OF THIS EXEMPTION, DATA BY ADVICE VIA FITBIT WOULD NOT MEET THIS EXEMPTION. 7, DOES EITHER THE INTERVENTION OR METHODS USED TO COLLECT DATA INTRODUCE RISK OF HARM, OFFENSE, EMBARRASSMENT, THESE ARE VERY NICE WORDS IN TERMS OF BEING ABLE TO LIMIT THE VARIOUS SITUATIONS THAT REASONABLY COULD COME UNDER THIS EXEMPTION. SO THE TERM BENIGN DESCRIBES AN INTERVENTION -- ORDINARY MILD TRANSIENT FORMS OF DISCOMFORT SUCH AS THE STRESS ASSOCIATED WITH COMPLETING A TIMED COGNITIVE TASK, ET CETERA, ARE CONSISTENT WITH THE EXEMPTION. SIMILARLY WHILE RESEARCH CANNOT MEANINGFULLY ELIMINATE ALL RISK, THE RESEARCH SHOULD INCLUDE ONLY -- CONSIDERING THE CHARACTERISTICS OF THE SUBJECT POPULATION, THE RESEARCH CONTEXT, AND HOW THEY MIGHT IMPACT THE SUBJECT'S EXPERIENCE OF THE RESEARCH INTERVENTION. AND SO INTERESTINGLY, THIS LOON HERE WITH THE CHARACTERISTICS OF THE SUBJECT POPULATION ACTUALLY DOES PLAY INTO THAT NEW QUESTION TOO. WERE THERE COMMENTS ABOUT HOW THIS HAS BEEN DESCRIBED? >> MICHELE, I DON'T UNDERSTAND WHAT YOU ARE WHY YOU ARE EXCLUDING THE PASSIVE COLLECTION OF DATA LIKE IN A FITBIT? >> SO MY UNDERSTANDING IS THAT THE WAY THE DATA ENTRY IS WRITTEN INTO THE WORDS OF THE EXEMPTION, IT IS INTERPRETED BY OUR COLLEAGUES IN THE GOVERNMENT AS REQUIRING ONLY DATA ENTRY BY THE SUBJECT. MY DATA ENTRY ON A COMPUTER, MY KAY TA DATA ENTRY ON A PIECE OF PAPER BUT IT DOESN'T INCLUDE DATA ENTRY PICKED UP BY A DEVICE. >> IN MY INTERPRETATION, WHICH MAY NOT BE THE GOVERNMENT, IS THAT THIS IS A VERY NARROW EXEMPTION FOR BEHAVIORAL RESEARCH, AND I THINK WHEN WE DISCUSSED IT LAST TIME, IF YOU OPEN THE DOOR, THE COLLECTION BY A DEVICE, YOU CAN START ADDING BLOOD PRESSURE MONITORS, ALL SORTS OF THINGS THAT ARE ABSOLUTELY MINIMAL RISK BUT ARE COVERED ELSEWHERE. SO THAT THEY'LL TYPICALLY FALL UNDER AN EXPEDITED REVIEW CATEGORY AS MINIMAL RISK RESEARCH. AND I DON'T THINK THAT'S THIS -- MY UNDERSTANDING OF THE INTENT OF THIS WAS TO TAKE A REALLY BIG CHUNK OF SOCIAL AND BEHAVIORAL RESEARCH THAT DOESN'T BENEFIT IRB REVIEW OFF THE TABLE, BUT WHEN YOU START POKING AT THE INDIVIDUAL CRITERIA, IT CAN SORT OF GET GRAY AS TO WHERE IT STOPS BEING SOCIAL BEHAVIORAL AND WHEN IT STARTS TO BE BIOMEDICAL, AND THIS WAS NOT INTENDED TO APPLY TO BIOMEDICAL. >> SO MOVING ON TO 8 -- HOW MUCH TIME DO WE HAVE, JULIA? LET'S NOT TAKE THE WHOLE HOUR. IS THE RESEARCH BRIEF IN DURATION? WELL, THAT'S A REALLY SHORT SENTENCE RIGHT THERE, BRIEF IN DURATION IS INTENDED TO MEAN A FEW MINUTES TO A FEW HOURS, BUT WHEN YOU ACTUALLY WORK THROUGH DIFFERENT EXAMPLES AND SO AGAIN, THERE ARE EXAMPLES AT THE END OF IT, IF YOU HAVE A NURSING HOME, AND YOU HAVE AMBIENT MUSIC PLAYED EVERY NIGHT FOR AN HOUR FOR THREE WEEKS, IS THAT BRIEF IN DURATION, IF YOU HAVE SOMEBODY SITTING DOWN AND DOING A COMPUTER TASK FOR THREE HOURS AND YOU GIVE THEM TWO BREAKS, IS THAT BRIEF IN DURATION? AND WHEN WE DISCUSS THAT EXAMPLE HERE, PEOPLE SAID, WELL, WE DO THINK IT'S BRIEF BUT BECAUSE THEY'RE GIVING BREAKS, THEN WHAT WE'RE REALLY THINKING ABOUT IS THAT WE DON'T WANT PEOPLE FATIGUED, SO THAT WAS WHY THE WORD FATIGUED ENDED UP IN THERE, BUT THEN THE SUBCOMMITTEES TOOK IT OUT, WHICH IS WHY IT'S MY JOB TO MAKE SURE YOU ALL KNOW THAT WE TOOK IT OUT. AND SO TAKING US BACK TO THE PURPOSE OF ANY GUIDANCE DOCUMENT, WHICH IS TO HELP THE COMMUNITY, TO WHEN SOMEBODY IS MAKING A DECISION WHETHER SOMETHING FITS THE BY NINE BEHAVIORAL INTERVENTION EXEMPTION, AND THEY'RE GIVEN A CERTAIN FACT PATTERN, HOW DO THEY KNOW? WHAT ARE THE PARAMETERS THAT THEY HAVE TO WORK WITH TO FIGURE OUT IS IT REALLY BRIEF. I THINK THAT THIS HAS BEEN SOMETHING THAT WE'VE ALL STRUGGLED WITH ON THE MAWN COMMITTEE SIDE AN ON THE BUT AGAIN GOING BACK TO THE PURPOSE OF THIS, THIS IS AN EXEMPTION. THERE'S NO OVERSIGHT. IT'S FOR THINGS THAT ARE REALLY, REALLY BENIGN. SO IF WE GO DOWN THE RABBIT HOLE OF TRYING TO FIT IN TO BRIEF IN DURATION MANY DIFFERENT SCENARIOS, WE MAY ACTUALLY BE MISSING THE FOREST FOR THE TREES AND NOT ENDING UP PROVIDING THE COMMUNITY WITH THE KIND OF GUIDANCE THEY NEED BECAUSE SOME OF THESE THINGS MAY BE JUST SIMPLY CAN BE EXPEDITED AND IT'S NOT THE END OF THE WORLD. THAT SAID, I'M STILL NOT SURE THAT BRIEF IN DURATION IS INTENDED TO MEAN A FEW MINUTES TO A FEW HOURS IS SUFFICIENT INFORMATION TO HELP THE COMMUNITY BECAUSE WE CAN ALL SITTING IN THIS ROOM HAVE DIFFERENT IDEAS OF HOW MANY HOURS IS A FEW HOURS. SO LET ME THROW OUT, THE OPTIONS ARE TO LEAVE THIS AS IT IS, TO MAYBE GO BACK TO CONSIDERING ADDING THE WORDS THAT WERE THERE BEFORE SO LONG AS SUBJECTS ARE NOT FATIGUED OR INCONVENIENCED, OR A THIRD OPTION IS TO ADD SOME OTHER QUALIFYING LANGUAGE THAT WOULD HELP PEOPLE KNOW WHEN THEY'VE REACHED THE LINE WHERE THEY NEED TO SEND SOMETHING OVER INTO AN EXPEDITED CATEGORY. >> I DON'T THINK WE CAN GET TOO EXPLICIT BECAUSE FOR ALL THE REASONS WE'VE TALKED ABOUT, THERE'S JUST SO MANY DIFFERENT SCENARIO, BUT PERHAPS JUST ADDING SOME LANGUAGE, WHAT REALLY NEEDS TO BE DONE IS PEOPLE NEED TO CONSIDER BOTH THE NATURE OF THE INTERVENTION AND THE CHARACTERISTICS OF THE SUBJECT POPULATION, AND PERHAPS PUTTING IN A SENTENCE THAT STATES SOMETHING TO THAT EFFECT, THAT IN DETERMINING WHETHER THIS -- DETERMINING WHETHER THE RESEARCH INTERVENTION IS BRIEF, SHOULD CONSIDER THE NATURE OF THE RESEARCH INTERVENTION ITSELF, AND THE CHARACTERISTICS OF THE SUBJECT POPULATION. IT'S SORT OF THAT INTEGRAL OF INTENSITY AND DURATION, I THINK IS WHAT WE WANT PEOPLE TO CONSIDER. >> IN LOOKING AT THIS AND THE EXAMPLES THAT YOU IMAIF, I WAS THINKING IF YOU ADDED "ON A SINGLE OCCASION," WHICH AGAIN IF WE'RE LOOKING AT BETWEEN BEING VERY CLEAR FOR AN EXEMPTION AND THE WORST BEING YOU GO ON TO EXPEDITED AND THINKING A NURSING HOME OVER TWO WEEKS, EVEN IF IT'S ONLY FIVE MINUTES, THAT YOU JUST SAY THAT GOES TO EXPEDITED IF WE THINK A SHORT PERIOD ONE TIME THAT, THAT MIGHT HELP GIVE SOME CLARITY HERE AND IT'S IN KEEPING WITH THE CONVERSATION LAST TIME. >> I AGREE AND I THINK IT WOULD BE VERY HELPFUL TO IRBs TO HAVE SOME CLARITY HERE, BECAUSE ONCE YOU GET INTO THE LET'S TAKE INTO ACCOUNT THE NATURE THE INTERVENTION AND THE NATURE THE POPULATION, THEN WE'RE INTO A LONG DISCUSSION. THIS IS REALLY SUPPOSED TO BE SIMPLE AND STRAIGHTFORWARD, IS MY OPINION. >> SO I DON'T DISAGREE WITH THE OTHER COMMENTS. ON THE OTHER HAND, THIS IS A GUIDANCE DOCUMENT, NOT A DIRECTIVE, AND IT SEEMS TO ME THAT LANGUAGE PLUS THE TWO EXAMPLES THAT APPEAR LATER IN THE DOCUMENT, THE ONE ABOUT THE MUSIC AND THE ONE ABOUT THE THREE HOURS WITH THE TRAINING PROVIDE A SENSE OF WHAT WE THINK IS OKAY AND WHAT WE DON'T -- WHAT WE THINK IS PROBABLY NOT OKAY. >> I GUESS I WOULD DISAGREE WITH HAVING SPECIFYING SOMETHING AS PRESCRIPTIVE THAT IT HAS TO BE A SINGLE EPISODE, BECAUSE WHAT IF IT WAS TWO FIVE-MINUTE INTERVENTIONS, ONE IN THE MORNING, ONE IN THE AFTERNOON, FOR A NORMAL HEALTHY PERSON, THAT'S STILL PRETTY BRIEF. SO I THINK IF WE START GETTING PRESCRIPTIVE, THEN WE REALLY LOCK PEOPLE IN. BY THE NATURE OF WHAT IRBs DO, JUDGMENT IS GOING TO BE REQUIRED, AN AND I THINK IT'S GOING TO BE -- I THINK WITH THE EXAMPLES AND IMIFN ALL OF THE GIVEN ALL OF THE OTHER DISCUSSION AS TO WHAT THIS EXEMPTION IS ABOUT, I DON'T THINK WE'LL BE PUTTING PEOPLE AT RISK BY KEEPING IT SOMEWHAT OPEN, BUT I WORRY ABOUT LOCKING IT IN TO JUST SAYING A SINGLE INTERVENTION OR SINGLE EPISODE. >> WHO ARE WE THINKING IS GOING TO BE MAKING THE JUDGMENT HERE? IS THIS SOMETHING -- THIS IS THE RESEARCHER MAKE THE JUDGMENT? >> IT'S AN EXEMPTION, SO AS WE'VE TALKED ABOUT IN THE PAST IN HERE, YOU KNOW, IT'S NOT -- THE EXPECTATION, I THINK, IS THAT IRBs WILL BE DETERMINING WHETHER THINGS ARE EXEMPT OR NOT. I DON'T THINK THAT NEW FINAL RULES MANDATES THAT, BUT THE PRACTICE OF THE VAST MAJORITY OF INSTITUTIONS REQUIRE THAT -- >> SO DEPENDING ON INSTITUTIONAL POLICY COULD BE THE IRB, COULD BE THE RESEARCHER, IT COULD BE SOME FUTURE TOOL THAT GETS DEVELOPED IN THE FUTURE. WHICH IS, TO ME, THAT'S WHAT PUSHES TOWARDS SPECIFICITY, BECAUSE WHEN YOU ARE TRYING TO MAKE A DECISION, DOES THIS CLEARLY FIT INTO A VERY BENIGN CATEGORY THAT REALLY DOESN'T REQUIRE A LOT OF FUSS, AND THE DECISION MAKER COULD BE RECEIPT SECHER, I THINK IT'S REALLY MUCH BETTER TO BE SPECIFIC AND IF THERE'S A LOT OF DOUBT, YOU KNOW, THEY GO TO EXPEDITED REVIEW. IT'S NOT THAT BIG A DEAL. SO I GUESS THAT'S THE REASON I'M SORT OF PUSHING TOWARD YEAH, OKAY, FINE, WE ARE TRADING OFF THAT MAYBE THERE'S A LITTLE LACK OF FLEXIBILITY HERE, BUT I THINK GIVEN THE SITUATION IN WHICH IT'S LIKELY TO BE USED, CLARITY IS THE MORE IMPORTANT CHARACTERISTIC. >> SO I UNDERSTAND WHERE YOU'RE COMING FROM. I'M A LITTLE CONCERNED BECAUSE -- THE ISSUE IS, AGAIN, THAT PEOPLE CAN INTERPRET THINGS DIFFERENTLY. SO IF YOU DID HAVE AN EXEMPTION TOOL AND YOU HAD THE WORD PAINFUL OR HARMLESS, WHAT I THINK IS HARMFUL OR HARMLESS MIGHT NOT BE WHAT DAVID THINKS IS HARMLESS OR THE RESEARCHER WHO'S DOING MANDATORY BIOPSIES MIGHT THINK IS HARMLESS. AND SO I'M JUST WORRIED ABOUT ORIENTING THE GUIDANCE TOWARD THE TOOL THAT DOESN'T EXIST YET WHERE YOU COULD HAVE ISSUES RELATING TO ANY ONE OF THE WORDS THAT ARE IN THE INTERVENTION. BUT I DO THINK THAT ACTUALLY THE TWO EXAMPLES, IF YOU'VE LEFT NUMBER 8 THE WAY IT IS, AND YOU HAD INCLUDED THE EXAMPLES, THEY DO PROVIDE A REALLY STRONG INTERPRETIVE FOUNDATION FOR IT. IF YOU TOOK THE EXAMPLES AWAY, I THINK THEN WOULD YOU HAVE A LOT MORE FLEXIBILITY IN TERMS OF HOW YOU COULD INTERPRET IT. BUT IT'S FOR THIS GROUP TO DECIDE. SO I THINK WHAT'S ON THE TABLE IS WHETHER WE SHOULD ADD SOMETHING THAT LIMITS BRIEF IN DURATION TO A FEW MINUTES TO A FEW HOURS ON A SINGLE OCCASION. >> SO LET'S TAKE A STRAW VOTE TO GET A SENSE OF THE GROUP. SO IF YOU FEEL WE SHOULD ADD THAT LANGUAGE, JUST RAISE YOUR HAND. FOR THAT PARTICULAR FOR THE SPECIFICITY, WOULD IT BE A SINGLE OCCASION? WE CAN TALK ABOUT OTHER SPECIFICITY LATER. AND PEOPLE WHO FEEL THAT IT SHOULD NOT BE FURTHER QUALIFIED WHY THAT WAY. SO IN THAT WAY. I THINK WE'VE HEARD THE ARGUMENTS, THINK THE SENSE OF THE COMMITTEE AS A WHOLE IS NOT TO ADD THAT IN. >> OKAY. >> JERRY. >> IF I COULD JUST COMMENT FROM A REGULATORY PERSPECTIVE WHICH AGAIN, YOU CAN VOTE WHICHEVER WAY YOU WANT, BUT IT SOUNDS LIKE YOU'RE SAYING IF YOU DON'T WANT TO QUALIFY THAT, IT'S LEAVING SOME AMBIGUITY OF WHAT MICHELE WAS NOTING IN TERMS OF THE EXAMPLES IN THERE, BECAUSE IF YOU'RE SAYING THAT EITHER, YOU KNOW -- AND ONE OF THE GOALS OF THE NEW RULES IN THE FIRST PLACE IS TO GET A FAIR AMOUNT OF UNIFORMITY IN TERMS OF HOW IRBs FUNCTION. SO EITHER IT DOES HAVE TO BE A SINGLE OCCASION OR IT DOESN'T. IF YOU'RE CONCLUDING THEN THE RESULT OF THE WINNING VOTE HERE IS THAT IT DOESN'T HAVE TO BE A SINGLE OCCASION, IT WOULD BE NICE TO SAY THAT, AND IF YOU THEN SAID THAT, THE QUESTION IS HOW DOES THAT BECOME CONSISTENT WITH THE EXAMPLE WHICH IS -- THERE IS AN EXAMPLE OF DOING SOMETHING ONCE A DAY IN THE NURSING HOME, WHATEVER, THE ACTUAL INTERVENTIONS WHEN ADD UP TOGETHER ADD UP TO LESS THAN A FEW HOURS. BUT IT SAYS THAT'S NOT OKAY. AND THEN IT'S NOT CLEAR TO ME THAT'S NOT OKAY IF YOUR ACTUALNG RULE THAT YOU STATED IS THAT IT'S PERFECTLY OKAY FOR IT TO BE BRIEF IN DURATION. SO IT JUST STRIKES ME AS THERE IS AN ISSUE HERE, AND DWEP, IT'S UP TO YOU TO WHICH WAY YOU WANT TO COME OUT ON THE SUBSTANTIVE INTERPRETATION, BUT IT SOUNDS LAKE YOU ACTUALLY ARE RESOLVING THE SUBSTANTIVE INTERPRETATION IN SAYING THAT IT DOESN'T HAVE TO BE THE SINGLE OCCASION, BUT THEN YOU HAVE AN INCONSISTENCY BETWEEN WHAT THIS SAY, THAT'S WHY I THINK IT WOULD BE NICE FOR YOU IN THIS SECTION TO ACTUALLY SAY IF YOU WANT TO SAY IT DOESN'T HAVE TO BE A SINGLE OCCASION, THEN SAY THAT, THEN COME UP WITH A JUSTIFICATION FOR ANOTHER EXAMPLE. >> SO WHAT IF WE ADDED A SENTENCE THAT SAYS SOMETHING LIKE WHILE IT DOES NOT HAVE TO BE A SINGLE OCCASION, THE ENTIRE TIME FOR THE ENTIRE INTERVENTION SHOULD NOT BE MORE THAN A FEW MINUTES OR A FEW HOURS IN TOTAL. SOMETHING LIKE THAT? >> I LIKE THAT IDEA, I COULD LIVE WITH IT. WHAT LESLIE AND I WERE JUST DISCUSSING WAS MAYBE WHAT WE'RE REALLY GETTING AT IS THAT IT SHOULD ALL OCCUR ON A SINGLE DAY, BECAUSE IT'S THE SHORT INTERVENTIONS OVER THE PERIOD OF MULTIPLE DAYS OR WEEKS THAT START TO MAKE IT FEEL NO LONGER BRIEF. I DON'T KNOW IF THAT MEETS YOUR CONCERN, JONATHAN. BECAUSE I'M CONVINCED BY YOUR EXAMPLE, 5 MINUTE IN THE MORNING, 5 MINUTES IN THE AFTERNOON STILL SEEMS TO ME TO BE BRIEF, AND THERE'S SOME JUDGMENT CALL, IF IT'S FIVE MINUTES IN THE MORNING TWO DAYS, STILL PROBABLY BRIEF, BUT WE NEED TO HAVE SOME CLEAR-CUT RULE, SO I COULD LIVE WITH INTERVENTIONS THAT ARE BRIEF WITHIN A SINGLE DAY. >> NO, WITHIN A SINGLE DAY. BECAUSE I WAS GOING TO SAY EXACTLY THE SAME THING, AND WHAT I'M THINKING ABOUT IS FROM THE STANDPOINT OF HOW LONG AM I GOING TO BE A SUBJECT. SO IF YOU HAVE A 24-HOUR PERIOD THAT STARTS AT NOON ON ONE DAY AND ENDS AT NOON ON THE NEXT DAY, THEN YOU'RE A SUBJECT FOR TWO DAYS. >> HOW WOULD YOU SPECIFY IT? >> A DAY. >> BUT YEAH, IN A SINGLE KAY AS WE USUALLY SORT OF UNDERSTAND DAYS SEEMS TO ME TO BE A SENSIBLE LIMITATION BECAUSE, YEAH, FIVE MINUTES IN THE MORNING, FIVE MINUTES IN THE AFTERNOON MAKES SENSE, BECAUSE THEN YOU CAN SAY TO YOURSELF, I'M A RESEARCH SUBJECT FOR TODAY, YOU KNOW, TUESDAY, JULY 25TH, AND THAT'S IT. >> SO TAKING US BACK TO THE ISSUE THAT THE GOAL IS TO PROVIDE SOME PARAMETERS, HELP PEOPLE BE ABLE TO USE THIS, I ACTUALLY THINK THAT IF WE DO SAY SOMETHING LIKE IF YOU ADD UP EVERYTHING, IT ISN'T MORE THAN A FEW MINUTE OR A FEW HOURS IN A SINGLE DAY, THAT'S A LOT OF GOOD GUIDANCE. YOU CAN THINK OF A LOT OF SCENARIOS WHERE IT'S ACTUALLY PROBABLY PRETTY BENIGN BUT SPREADS OUT OVER TWO DAYS BUT IF YOU START GOING DOWN THAT RABBIT HOLE, THEN WE'RE GOING TO BE OPENING OURSELVES UP TO ANY NUMBER OF DIFFERENT SITUATIONS, AND I THINK WE JUST CAN'T FIX EVERYTHING. SO I PERSONALLY THINK THIS IS A NICE WAY TO SET CLEARER GUIDELINES. >> [INAUDIBLE] >> RIGHT, IN A SINGLE DAY. BUT I THINK IT STILL HAS TO BE BRIEF WITHIN THE CONTEXT OF THAT SINGLE DAY, BECAUSE YOU CAN'T HAVE -- I MEAN, 24 HOURS OR 12 HOURS IN A SINGLE DAY IS NOT BRIEF. SO I THINK IT STILL HAS TO BE -- COW DO IT IN THE YOU COULD DO IT IN THE MORNING, HAVE MORE IN THE AFTERNOON OR SOMETHING, BUT WHEN YOU CONSIDER THE TOTAL NUMBER OF TIME SPENT, IT STILL HAS TO BE BRIEF IN A SINGLE DAY. SO HOW ABOUT IF I WRITE SOMETHING UP AND THEN COME BACK TO THE GROUP? OKAY. THAT WAS GOOD. SO 9 IS AT LEAST ONE OF THE FOLLOWING CONDITIONS REGARDING PRIVACY PROTECTIONS MET. IN ADDITION TO THE EXPLICIT LIMITS ON THE RISK OF HARM DESCRIBED IN THE REGULATORY LANGUAGE, AND IMPLIED IN THE EXAMPLES ONLY HUMAN SUBJECT RESEARCH THAT INTRODUCES LITTLE OR NO RISK OF HARM TO SUBJECTS' PRIVACY AND M INTEREST MAY BE EXEMPT FROM IRB REVIEW UNDER THIS CATEGORY OR SUBJECT TO LIMITED IRB REVIEW. DAMAGING TO THE SUBJECT'S REPUTATION INCLUDE CIRCUMSTANCES WHERE A SUBJECT IS LIKELY TO FEEL THAT DISCLOSURE WOULD CAUSE SIGNIFICANT EMBARRASSMENT. SO ARE THERE COMMENTS ABOUT THIS? PRETTY STRAIGHTFORWARD? SO THE EXAMPLES. SHALL WE GO THROUGH THE EXAMPLES? >> THERE'S SOME ADDITIONAL QUESTION OR DISCUSSION ABOUT PRISONERS THAT SOME MEMBERS -- >> I JUST WANT TO RE-RAISE THE PRISONER ISSUE. I THINK THE EXAMPLE THAT SOMEONE IS INCARCERATED HAPPENS TO BE INCARCERATED IN AN ICU IS QUITE -- THEY'RE IN AN ICU AND THEY'RE AN INCARCERATED PERSON, CHAINED TO THE BED OR WHATEVER THEY R AND YOU'RE GOING TO DO A BRIEF BEHAVIORAL INTERVENTION ON THEM SEEMS MILDLY FAR FETCHED TO ME, BUT OKAY. BUT WHEN YOU'RE ACTUALLY GOING INTO A PRISON, OR A JAIL, AND YOU ARE NEGOTIATING WITH THAT PRISONER JAIL TO GET THIS PERSON ALLOWED TO PARTICIPATE IN WHATEVER IT IS YOU'RE GOING TO DO, I THINK THAT YOU'RE IN AN ENTIRELY DIFFERENT SITUATION. THERE'S AN ELEMENT OF COERCION FOR SOMEONE SIMPLY BEING IN A PRISON OR JAIL. THE INCENTIVES FOR PARTICIPATION AND THE INTERPRETATION FOR VOLUNTARINESS IS QUITE DIFFERENT, AND I RELE FIND REALLY FIND IT VERY DIFFICULT TO IMAGINE THAT BENIGN BEHAVIORAL INTERVENTION, EVEN A BENIGN BEHAVIORAL INTERVENTION, THAT WILL BE A NOTHING FOR SOMEONE WHO IS NOT INCARCERATED, IS THE SAME FOR SOMEONE WHO IS INCARCERATED. AND I JUST FIND IT AMAZING THAT YOU COULD THINK ABOUT EXEMPTING THAT. I MEAN, SOMEONE NEEDS TO THINK SERIOUSLY ABOUT WHAT'S THE MEANING OF GOING INTO THIS SITUATION OF INCARCERATION AND ATTEMPTING TO ENGAGE SOMEONE IN RESEARCH. >> BUT THAT'S EXACTLY WHAT WE'RE GOING TO DO WITH THIS ADDITIONAL QUESTION, THAT IS GOING TO BE DRAFTED TO ADDRESS THE OTHER CATEGORIES OF VULNERABILITY -- [INAUDIBLE] THAT INCLUDES PRISONERS, THE LANGE WAMG OF LANGUAGE OF T HE REGULATION -- [INAUDIBLE] WE'VE ALREADY SAID, IT CAN'T BE CHILDREN, IT CAN'T BE PEOPLE WITH IMPAIRED DECISION-MAKING CAPACITY, PEOPLE WHO ARE ECONOMICALLY DISADVANTAGED, AND THAT ALL HAS TO DO WITH WHETHER THEY'RE MORE SUBJECT TO COERCION OR UNDUE INFLUENCE, SO THAT QUESTION IS GOING TO HAVE TO LOOK AT THE OTHER CATEGORIES OF VULNERABILITY, THE POSSIBILITY OF COERCION AND UNDUE INFLUENCE AND THE POSSIBILITY OF WHETHER BENIGN INTERVENTIONS THAT WOULD BEBENIGN FOR OTHERS AROUND UNDER THE CIRCUMSTANCES BENIGN FOR THOSE GROUPS. SO >> SO IF I COULD INTERRUPT AND CLARIFY SOMETHING HERE. I DON'T THINK THAT THIS EXEMPTION APPLIES TO ALLOW PEOPLE TO GO TO A PRISON AND NEGOTIATE WITH A WARDEN TO USE THE POPULATION FOR BENIGN BEHAVIORAL INTERVENTIONS BECAUSE WHAT IT SAYS IS THE EXEMPTIONS OF THIS SECTION DO NOT APPLY TO RESEARCH SUBJECT TO SUBPART C EXCEPT FOR RESEARCH AIMED AT A BROADER SUBJECT POPULATION THAT ONLY INCIDENTALLY INCLUDES PRISONERS. AND IT JUST SEEMS TO ME THAT AS SOON AS YOU WALK IN THE DOOR AND START NEGOTIATING TO INCLUDE A PRISONER POPULATION, YOU ARE OUT OF THIS EXEMPTION. SO THAT THE CONCERNS YOU HAVE HAVE BEEN ADDRESSED IN THE FINAL RULE BY THIS SECTION. BUT AGAIN, OUR COLLEAGUES FROM OHRP CAN -- >> THAT WAS MY POINT TOO, THAT IT SAYS YOU CAN'T GO IN AND DO THAT. NONE OF THE EXEMPTIONS APPLY UNDER THAT CIRCUMSTANCE, AND I THINK WHETHER IT'S THE ICU OR I KNOW MANY IRBs, IF SOMEBODY IS A PA ROW PAROLEE WILL COUNT AS A PRISONER, SO WHERE YOU'RE DIRECTING SOMETHING AT A LARGER POPULATION AND SOMEBODY WHO IS OUT IN THE WORLD BUT STILL CONSIDERED A PRISONER FOR PURPOSES OF THE REGULATION COULD HAPPEN TO SIGN UP FOR THE WALKING WELLNESS INTO MUSIC OR WHATEVER BENIGN -- SO I THINK YOUR CONCERNS ARE LEGITIMATE BUT TAKEN CARE OF ALREADY HERE. >> THAT'S NOT WHAT I HEARD JERRY SAY, WHICH WAS THAT SUPPOSE SOMEONE FALL NOOSE A PARTICULAR CATEGORY, WHICH IS THE SUBJECT OF THIS PARTICULAR STUDY, BUT THEY HAPPEN TO BE INCARCERATED. BECAUSE THEY ARE INCIDENTALLY INCARCERATED, PERHAPS THEY WERE SIMPLY RE-ARRESTED, THEY WERE OUT WHEN THEY WERE PICKED BUT NOW THEY'RE IN JAIL OR SOMETHING LIKE THAT, SO PLEASE CLARIFY. >> I DON'T THINK BY ITS WORDING THE EXEMPTION PREVENTS IT FROM APPLYING TO PEOPLE WHO WERE ACTUALLY PRISONERS, WHICH THE MOST COMMON GROUP OF ARE PEOPLE WHO ARE ACTUALLY IN PRISON. YOU COULD BE DETERMINING THE PEOPLE WHO ARE ELIGIBLE FOR YOUR STUDY BY A UNIFORM CRITERION THAT WOULD PICK UP OUT OF THE THOUSAND PEOPLE ON A LIST OF PEOPLE WHO MEET THESE ELIGIBILITY CRITERIA, AGAIN INCIDENTALLY NOT BECAUSE THEY'RE PRISONERS BUT BECAUSE THEY JUST HAPPEN TO BE IN PRISON, ARE FIVE PEOPLE WHO HAVE A PARTICULAR CONDITION AND YOU WERE DOING SOME SORT OF BEHAVIORAL INTERVENTION THAT YOU WANTED TO SEE HOW SOMEBODY WHO HAS A PARTICULAR GENETIC CODING, WHATEVER IT IS, BEHAVES UNDER CERTAIN CIRCUMSTANCES. SO COULD THAT APPLY TO A FEW PRISONERS? I WOULD GUESS SO. AGAIN, THERE ISN'T GUIDANCE ON THIS, IT'S A NEW PROVISION, BUT I CAN'T SAY THAT IT ABSOLUTELY CAN APPLY. >> -- THESE PEOPLE WOULD BE PUT UNDER A LEVEL OF RISK THAT WOULD BE UP UNTENABLE, BUT I DO THINK IN AN EXEMPTION SITUATION, THE BURDEN IS ON WHOEVER IS MAKING THAT EXEMPTION DECISION TO JUSTIFY GOING INTO A PRISON AND EXPLAINING WHY IT IS ACTUALLY POSSIBLE FOR SOMEONE TO VOLUNTARILY AGREE TO PARTICIPATE IN THIS BENIGN BEHAVIORAL INTERVENTION, BECAUSE THAT IS NOT SOMETHING THAT ISIZE EE TO DO IS EASY DO IN AN INCARCERATION SITUATION. I CAN IMAGINE THERE WOULD BE PRESSURE TO SOMEONE TO PARTICIPATE IN SOMETHING LIKE THIS IF THEY ARE INCARCERATED. I CAN ALSO IMAGINE THEY WOULD LOVE TO PARTICIPATE IN SOMETHING LIKE THIS IF THEY'RE INCARCERATION AND THE INCARCERATION SITUATION IS JUST QUITE DIFFERENT. >> MY CONCERN HAD BEEN WHAT YOU RAISED, THAT SOMEBODY WOULD CREATE A RESEARCH PROTOCOL THAT SPECIFICALLY LOOKED AT PRISONERS BECAUSE I THINK THAT WOULD BE FOR MANY PEOPLE A POPULATION RIGHT, BUT THAT'S NOT SOMETHING THAT THEY CAN DO UNDER THE EXEMPTION. I THINK THERE IS ALWAYS GOING TO BE A FUZZY LINE. COULD YOU LOOKING AT A BENIGN BEHAVIORAL INTERVENTION THAT INVOLVES POTENTIAL FOR ADDICTION AND YOU'RE GOING TO HAVE A POPULATION THAT HAS MORE PRISONERS THAN IF YOU LOOKED AT A DIFFERENT TYPE OF BENIGN BEHAVIORAL INTERVENTION, BUT I THINK THAT THE THOUGHT THAT YOU CAN ENROLL SUBJECTS WHO HAPPEN TO BE WITHIN THE CORRECTION SYSTEM IN WHATEVER WAY, WHETHER ON PAROLE OR LOCALLY JAILED, AS LONG AS IT IS NOT TARGETING THAT POPULATION DOES NOT SEEM UNREASONABLE. >> I ALSO DON'T THINK YOU CAN MEET IF YOU'RE TARGETING, BECAUSE AGAIN, THE LANGUAGE IS INCIDENTAL. SO I DON'T BELIEVE THAT YOU COULD USE THIS IF YOU WERE TARGETING PRISONERS AND IF YOU WENT TO IT -- AND AS SOON AS YOU GO TO A PRISON, TO ME YOU'RE TARGETING PRISONERS. IF YOU HAVE AN ADDICTION RECOVERY MEETING AT A CHURCH, AND IT HAPPENS THAT SOME OF THE PEOPLE THERE ARE BEING BROUGHT IN FROM A PRISON, AND WHAT YOU'RE LOOKING AT IS WHETHER HAVING MUSIC PLAYING IN THE BACKGROUND HELPS THE DISCUSSION -- BEAR WITH ME ON THIS, I'M TRYING TO FIGURE OUT SOME EXAMPLE. YOU KNOW, THE MUSIC IS CLEARLY BENIGN, THE FACT THAT THEY'RE PRISONERS IS INCIDENTAL TO THEM BEING THERE, NOBODY WALKED INTO A PRISON AND SAID THEY WERE GOING TO DO THIS RESEARCH THERE, ALTHOUGH I'M SURE THERE ARE PEOPLE WHO WOULD ARGUE THAT IF YOU DID HAVE MUSIC PLAYING IN A PRISON, IT'S BENIGN, BUT THAT'S PRIEST PREE SEISELY WHAT WE DON'T WAN WANT TO HAVE EXEMPTED, THAT WOULD BE EXCEPTED OR HEADED TO ANOTHER CATEGORY. I THINK IF IT ISN'T TARGETING, YOU CAN'T TARGET PRISONERS AND THEY REALLY JUST HAVE TO BE INCIDENTAL TO THE BROADER POPULATION. >> SO LET ME ASK A QUESTION THAT MAYBE IS CLARIFYING BUT MAYBE NOT, AND THAT IS IF YOU DO INVOLVE -- IF RIS NERS GET CAUGHT UP, IS THE COMPROMISE -- AND THAT'S AN YOU A AUTONOMY ISSUE. THE FREEDOM TO PROSPECTIVELY AGREE WITH THE SAME LACK OF CONSTRAINTS IN THE GENERAL POPULATION, SO THAT'S WHAT WE NEED TO BALANCE AGAINST -- IT'S MINIMAL RISK BENIGN INTERVENTION, SO IS THAT SUFFICIENT TO FURTHER QUALIFY THE GUIDANCE BASICALLY, THAT'S WHAT WE'RE TALKING ABOUT. ALL OF THIS IS LOW RISK, THERE ARE LOTS OF PROTECTIONS THAT IT'S NOT GOING TO AFFECT ANY OF THE PARTICIPANTS ADVERSELY. SO ARE THE AUTONOMY CONSTRAINTS ON PRISONERS WHO I THINK THE GENERAL DISCUSSION THAT THEY'RE NOT GOING TO BE INCARCERATED, LIKELY NOT TO BE IB CARS RATED DURING THE INTERVENTION, WHETHER THAT'S BECAUSE THEY'RE BUST TO AN ADDICTION THING OR -- IS THAT SUFFICIENTLY OF CONCERN IN THIS CIRCUMSTANCE OR DO WE FEEL SUFFICIENTLY STRONGLY TO FURTHER QUALIFY? >> I GUESS I WOULD SAY THE FLIP SIDE OF THAT ISSUE IS THEN IF YOU DO FURTHER QUALIFY, YOU THEN MAY BE EXCLUDING A POPULATION FROM PART PAITION IN THE RESEARCH THAT PERHAPS COULD BE BENEFICIAL. BY DEFINITION, IF IT'S IN THIS EXEMPTION, IT'S OF VIRTUALLY NO RISK, SO AT WORST IT'S OF NO BENEFIT AND POSSIBLY IT'S OF SOME BENEFIT. AND SO WHAT'S THE HARM OF LETTING THEM IN? >> WHAT'S THE HARM IN THIS SITUATION OF SAYING THAT IF YOU'RE GOING TO GO INTO A PRISON OR -- >> I THINK WE'RE NOT GOING INTO A PRISON, WE CAN'T GO INTO A PRISON. >> IT DOESN'T SAY THAT IN HERE. >> THAT WOULD NOT BE INCIDENTAL TO THE STUDY. >> I WOULD MAKE THE SECONDARY ARGUMENT THAT IF YOU HAVE BEEN BUSSED TO A SESSION OF SOME KIND KIND, AND YOU ARE REQUIRED TO STAY THERE FOR THIS SESSION, THAT YOUR LEVEL OF VOLUNTARINESS IS QUITE DIFFERENT FROM SOMEONE WHO COULD GET UP AND LEAVE. BUT LEAVING THAT ASIDE, ONLY SIMPLY SAYING IF YOU'RE GOING TO DEAL WITH PEOPLE THAT ARE PRISONERS UNDER THE GUIDELINES, YOU SHOULD AT LEAST BE DEALT WITH AN AN EXPEDITED REVIEW AND NOT EXEMPTED. JUST HAVING SOMEONE TAKE A LOOK AT AN EXPEDITED REVIEW IS NOT A HIGH BAR, BUT I MEAN, THERE JUST ARE DIFFERENT ISSUES FOR PRISONERS. >> JUST ANOTHER QUESTION. IS THERE AN ISSUE FOR PEOPLE WHO ARE, SAY, ON PAROLE. AS WE'VE DISCUSSED FOR THIS KIND OF THING, WHAT IF ONE IS ON PAROLE AND TAKING PSYCH 101, TEACH STUG DID YOU GOING STUDY UNDERWAY, I S IT -- >> [INAUDIBLE] [LAUGHTER] >> PRISON -- THEY DON'T APPLY TO PEOPLE ON PAROLE. IT'S DEFINITELY SOMETHING ONE MIGHT THINK ABOUT BUT -- >> I SEE NODS AND SHAKING HEADS AT THE SAME TIME. SO I'M NOT SURE WHAT TO DO WITH THAT. HOLLY AND LESLIE, DO YOU WANT TO COMMENT? >> I THINK THAT THIS IS GOING TO BE RESOLVED IN THE LANGUAGE THAT MICHELE IS GOING TO ADD, WHICH I'M HAPPY TO WORK ON DURING A BREAK ABOUT VULNERABLE POPULATIONS. THAT'S REALLY THE ISSUE HERE AND I THINK WE'VE KIND OF BEAT IT TO DEATH NOW THAT IT CAN BE THAT YOU'RE SPECIFICALLY TARGETING A PRISON POPULATION AND THE CIRCUMSTANCES IN WHICH PRISONERS MIGHT GET SWEPT UP INCIDENTALLY ARE UNLIKELY TO INVOLVE ACTUALLY STEPPING FOOT INTO A PRISON, IT MIGHT CATCH PEOPLE WHO ARE IN SORT OF HALFWAY HOUSES OR THOSE TYPES OF THINGS. WHICH I THINK CAN BE RESOLVED THROUGH THIS VULNERABILITY LANGUAGE. >> SO I'M JUST GOING TO ASK ONE MORE QUESTION. SO I THINK WHAT SANDRA IS GETTING TO IS THE AUTONOMY ISSUE, NOT THE RISK. AND THE RISK WOULD BE CAUGHT UP IN ALL THE OTHER KIE KROO TIER CRITERIA FO R HARMS, EMBARRASSMENT AND SUCH, BUT AUTONOMY IS NOT CAPTURED IN THAT. AND DO WE NEED TO ADD SOME LAPG LANGUAGE AROUND PROSPECTIVE AGREEMENT OR SOMETHING THAT PROVIDES THAT CLARITY? >> DRUG TREATMENT AS A CONDITION OF A COURT ORDERED DRUG TREATMENT, AND THIS IS BEING DONE IN A DRUG TREATMENT FACILITY. YOUR ABILITY TO SAY NO IS QUITE DIFFERENT. BECAUSE YOU ARE REQUIRED TO BE COOPERATIVE WITH THE DRUG TREATMENT PROGRAM THAT YOU'RE IN AND IF THIS IS YOU PART OF THE DRUG TREATMENT PROGRAM, YOU COULD BE IN TROUBLE IF YOU WANT TO WALK AWAY FROM IT. SO I THINK YOU CAN SOLVE THIS IN LANGUAGE AND I TRUST THAT LU, BUT THERE ARE AREAS OF DIMINISHED AUTONOMY FOR PEOPLE IN SOME KIND OF VOLUNTARY PROGRAM AND SORT OF SAYING, WELL, WE CAN DEAL WITH THIS AND EXEMPTION MIGHT NOT BE QUITE WHAT WE WANT TO DO, OR WE WANT TO PUT SOME LIMITATIONS ON THERE. YOU CAN SOLVE IT IN CRAFTING. AND CRAFT IT . >> OKAY. HOLLY, YOU'VE GOT A LUNCH PARTNER.. >> GRADUATE BUSINESS STUDENTS ARE ASKED TO PARTICIPATE IN RESEARCH EXAMINING THE INFLUENCE OF TIME SPENT SURFING A SOCIAL MEDIA SITE ON SELF CONTROL. STUDENT WERE RANDOMLY ASSIGNED TO BROWSE A POPULAR SOCIAL NETWORKING SITE OR A POPULAR NEWS SITE AND THEN AS A MEASURE OF SELF CONTROL AND PERSISTENCE WERE TIMED IN THEIR EFFORTS TO SOLVE A COMPLEX WORD PUZZLE FOR WHICH THERE WAS NO SOLUTION. NO IDENTIFIABLE INFORMATION IS RECORDED. THIS EXAMPLE DESCRIBES A BEHAVIORAL INTERVENTION. THE INTERVENTION IS BENIGN, IN THAT IT IB VOFLS NO APPRECIABLE RISK OF HARM OR PAIN OR EMOTIONAL DISTRESS FOR THE SUBJECTS. ASSUMING STUDENT AGREEMENT WAS OBTAINED FOR PARTICIPATION AND THE DATA WERE ANONYMOUS, THE STUDY WOULD MEET THE CRITERIA FOR BENIGN BEHAVIORAL INTERVENTION. >> [INAUDIBLE] >> REMINDER FOR EVERYBODY TO USE THEIR MICROPHONES WHEN THEY SPEAK. THANK YOU. >> OTHER COMMENTS? I HATE TO SAY THIS BUT I'M GOING TO. I'M GOING TO TAKE US SLIGHTLY BACK TO THE CONVERSATION ON PRISONERS AND AUTONOMY. AND JUST SAY THAT THERE ARE LOTS OF POPULATIONS WHERE ONE MIGHT SAY THAT IT WAS NOT ENTIRELY CLEAR THAT THERE WAS PROSPECTIVE AGREEMENT. EVEN THIS EXAMPLE WHERE YOU'RE TALKING ABOUT GRADUATE BUSINESS STUDENTS, YOU CAN IMAGINE SITUATIONS WHERE THERE'S HEAVY PRESSURE TO PARTICIPATE AS STUDENTS IN RESEARCH, CAN YOU IMAGINE BENIGN BEHAVIORAL INTERVENTIONS INVOLVING MUSIC WITH INDIVIDUALS WHO HAVE ALZHEIMER'S OR SOME COGNITIVE IMPAIRMENT WHERE THEY'RE ABLE TO GIVE PROSPECTIVE AGREEMENT, YOU DON'T NEED A LEGALLY AUTHORIZED REPRESENTATIVE, BUT I THINK WE HAVE TO BE CAREFUL BECAUSE WE JUST DON'T WANT TO TRY TO CAPTURE EVERYTHING BUT WE WANT TO MAKE SURE THAT THE HARM -- IN THIS CASE, BENIGN BEHAVIORAL, IT'S NOT HARMFUL, NOT PAINFUL, NOT EMBARRASSING, THERE'S ALREADY LOTS OF RESTRICTIONS ON IT, AND AS WE WORK THROUGH THIS ISSUE THAT NANCY AND HOLLY AND I WORK ON, WE JUST HAVE TO BE CAREFUL, I THINK, ABOUT IT. >> MICHELE, CAN I SUGGEST THAT WHEN YOU DO WORK ON IT, YOU CONSIDER ADDING THAT LANGUAGE TO QUESTION 3 ABOUT PROSPECTIVE -- >> RIGHT. >> BECAUSE I THINK JUST MAKING IT CLEAR, WHILE IT'S NOT CONSENT,MAYBE DON'T USE THE OTHER WORDS THAT WE ALWAYS USE AND CONFUSE BUT -- >> USE AND CONFUSE IS A GOOD PHRASE. TO STUDY THE IP FLEUNS OF RESTAURANT GRATUITY POLICIES ON OVERALL SATISFACTION, CUSTOMERS CALL FORG RESERVATIONS ARE ASKED TO TAKE PART IN A RESEARCH STUDY INVOLVING THE COMPLETION OF AN ANONYMOUS SURVEY FOLLOWING THEIR MEAL. ARE ALL OF YOU AS TIRED OF THESE SURVEYS AS I AM? I CAN'T CALL VERIZON, I CAN'T GET MY CAR FIXED WITHOUT SOMEBODY SENDING ME A SURVEY. IT'S NOT HUMAN RESEARCH -- THOSE ASSIGNED TO A FIXED SERVICE CHARGE IMREUP OR VOLUNTARY GRATUITY GROUP ARE INFORMED OF THIS, ALL ARE TOLD THAT CERTAIN ASPECTS OF THE RESEARCH WILL ONLY BE REVEALED TO THEM AT THE CONCLUSION OF THEIR INVOLVEMENT.& THIS EXAMPLE FULFILLS THE CRITERIA FOR EXEMPTION AS A BENIGN BEHAVIORAL INTERVENTION. SINCE NOT OF STUDY'S PURPOSE MAY INFLUENCE -- SUBJECTS ARE INFORMED OF THE RESEARCH OF THE FACT THAT THE RESEARCH INCLUDED DECEPTION AND THEY PROSPECTIVELY AGREE TO TAKE PART. THE RANDOM ASSIGNMENT IS BRIEF, HARMLESS, PAINLESS, NOT LIKELY TO HAVE A SIGNIFICANT ADVERSE IMPACT ON THE SUBJECT AND NOT LIKELY TO CAUSE OFFENSE OR EMBARRASSMENT. COMMENTS? OKAY. 3 -- JERRY? >> I GUESS I'M NOT SURE -- I'M NOT RAISING THIS AS A REGULATORY ISSUE BUT THIS GETS BACK TO THE BROADER ISSUE OF WHAT YOU'RE SUPPOSED TO BE TELLING THE SUBJECTS WHEN YOU'RE TELLING THEM SOMETHING IS HAPPENING TO THEM THAT THEY'RE GOING TO BE DECEIVED ABOUT AND YOU'RE NOT TELLING THEM THE NATURE OF THAT. AGAIN, THERE'S A PERSONAL TAKE ON THIS, I'M JUST CURIOUS BECAUSE I THINK ABOUT THESE SO IF I UNDERSTAND, YOU ARE ACTUALLY ALTERIG HOW MUCH THEY'RE GOING TO HAVE TO PAY IN TERMS OF GRATUITY, RIGHT? AND THEY'RE NOT BEING GIVEN A HINT ABOUT THAT IN TERMS OF TELLING THEM THAT DECEPTION IS GOING TO TAKE PLACE. AND -- >> IT COULD BE HARMFUL FOR YOUR -- >> THAT'S WHAT I'M SAYING, WHETHER OR NOT -- THAT YOU'RE ACTUALLY PAYING MORE AT THE RESTAURANT, WHAT IF WE'RE GOING TO DOUBLE THE COST OF THE MEAL TO YOU AND WE'RE NOT GOING TO TELL YOU THAT EITHER OR SOMETHING. WHICH AGAIN, I'M NOT SAYING AS A REGULATORY MATTER BUT GETTING TO THE HEART OF WHAT THIS PROVISION WAS ABOUT, IN TERMS OF TRYING TO BE TRUER TO WHAT IT'S GETTING AT, I CAN TELL YOU THE PURPOSE OF THE RESEARCH OR SOMETHING LIKE THAT. BUT OARPD, YOU'D BE DOING THE RESEARCH KNOWING THAT NOTHING IS GOING TO HAPPEN IN THE STUDY THAT, REALLY SOMEBODY SHOULD CARE GREATLY ABOUT ONE WAY OR THE OTHER. I SUSPECT SOMEBODY DID CARE ABOUT PAYING SIGNIFICANT AMOUNTS OF MONEY, IT DEPENDS ON THE PERSON, WHAT A SIGNIFICANT AMOUNT OF MONEY IS. SO -- >> IT WAS INTERESTING LISTENING TO YOU RAISE THIS BECAUSE I'M THINKING WHAT IF THEY PUT IN A 25% FIXED SERVICE CHARGE AND THE VOLUNTARY GROUP ONLY PAYS A 5% TIP. THAT'S A DIFFERENCE. >> WHY DID YOU CHANGE IT TO MAKE IT ONE GROUP GETS A SUGGESTED OR A SUGGESTED GRATUITY, SUGGESTED VOLUNTARY GRATUITY AND THE OTHER ONE GETS NO SUGGESTION. ONE GROUP IS SIMPLY GETTING A SUGGESTION, THE OTHER IS GETTING -- IN FACT THERE'S NO DIFFERENCE IN WHAT THEY CAN PAY, IT IS ACTUALLY A BEHAVIORAL INTERVENTION THAT IS BENIGN. >> IN FACT RELATED TO THAT, YOU COULD MANIPULATE THE STUDY SO THAT IT DOESN'T ACTUALLY ALTER WHAT GETS PAID. EVERYBODY ENDS UP BEING REIMBURSED IN A CERTAIN WAY OR WHATEVER IT IS, BUT YOU STILL COULD STUDY IT BECAUSE YOU CAN LOOK AT WHAT HAPPENS, THEN AFTERWARDS, YOU PUT THEM BACK AT WHERE THEY OTHERWISE WOULD HAVE BEEN. THE FACT THAT YOU'RE ALTERING HOW PEOPLE END UP IN TERMS OF BEING OUT OF POCKET MONEY HERE AND THERE WAS NEVER EVEN A HINT THAT THAT WAS A PART OF THE STUDY, I SUSPECT THAT RAISES A NON-TRIVIAL ISSUE HERE ABOUT WHAT YOU'RE ACTUALLY HIDING FROM THEM, THAT YOU'RE HIDING SOMETHING THAT MIGHT ACTUALLY MATTER TO PEOPLE. >> I'M THINKING HAVING THIS SUGGESTED SERVICE CHARGE VERSUS THE NO SUGGESTIONS ON THE SERVICE CHARGE MIGHT BE THE WAY TO GO WITH THIS. ANYBODY OPPOSED TO THAT? >> I'M JUST WONDERING IF WE CAN EVEN FIX THAT SENTENCE ABOUT THEY ARE INFORMED OF THIS. WE READ THAT A COUPLE TIMES AND I THINK IT COULD BE INTERPRETED A COUPLE WAYS, WHAT THE "THIS" IS. SO WHAT ARE THEY ACTUALLY BEING TOLD THAT -- THEY'RE BEING TOLD THEY'RE PARTICIPATING IN THE STUDY RELATED TO GRATUITY, BUT NOT WHICH ARM THEY'RE IN? >> HOW ABOUT IF WE WORK ON THIS? I JUST DON'T WANT US TO GET TOO DEEP IN THE DETAILS. I THINK WE ACTUALLY CAN FIX IT. >> IF WE WERE TOLD, LOOK, WE'RE GOING TO DO A STUDY ABOUT GRATUITIES, AND THEN THE FIXED SERVICE CHARGE GROUP IS TOLD SOMETHING LIKE IF YOU EAT AT THIS RESTAURANT, THERE'S A FIXED GRATUITY OF 20% OR SOMETHING, YOU'RE NOT NECESSARILY HIDING THE BALL, YOU'RE JUST HIDING THE BALL THAT THERE ARE OTHER PEOPLE WHO EXIST THAT ARE NOT BEING FIXED. >> LET'S TALK ABOUT THAT. GOOD POINT. GOOD POINTS. LET'S GO ON TO 3. ADULT LEARNERS ARE VIDEOTAPED WHILE READING A PASSAGE FROM A STANDARD TEXT WHILE ALONE IN A DWIE QIE ET ROOM. RATINGS OF VOCAL INFLECTION AND TONE ARE ASSESSED AS PREDICTERS OF COMPREHENSION AND COMPARED WITH THE RESULTS OF A WRITTEN TEST OF THE SUBJECT'S ABILITY TO UNDERSTAND THE SAME READING MATERIAL. THE PROCEDURES TAKE 90 TO 120 MINUTES. ASSUMING PROSPECTIVE AGREEMENT, THIS WOULD BE BRIEF IN DURATION. THE INTERVENTION HERE REQUIRES THE SUBJECT TO READ A PASSIONAGE. WHILE PUBLIC READING OR THE PERFORMANCE OF MATH PROBLEMS IN FRONT OF AN AWPPED YENS OF STRANGERS MAY BE USED TO PROVOKE A STRESS RESPONSE IN SOME RESEARCH, THE SUBJECT IN THIS EXAMPLE IS ALONE IN A QUIET ROOM AND READING FROM A STANDARD TEXT. THIS EXAMPLE WOULD BE CONSIDERED A BENIGN BEHAVIORAL INTERVENTION FOR WHICH EVEN UNINTENDED DISCLOSURE OF THE SUBJECT'S RESPONSES WOULD NOT BE DAMAGING TO EMPLOYABILITY OR REPUTATION OR BE SIGNIFICANTLY EMBARRASSING. COMMENTS? >> WHAT IF THEY DID REALLY BADLY AND IT WAS AN INDICATION OF COGNITIVE IMPAIRMENT? >> ANY TAKERS ON THAT? >> THEY'RE NOT BEING INFORMED AS TO, QUOTE, HOW THEY DID, SO IT WOULDN'T MATTER. >> IT'S REALLY ABOUT UNINTENDED DISCLOSURE. SO IT SAYS UNINTENDED DISCLOSURE. SO SUPPOSE IT WAS DONE IN A SITUATION WHERE IT COULD BE DISCLOSED TO SOMEONE, THEY'RE THEIR FAMILY MEMBER, THEIR WORK, SOMEONE WHO DROVE THEM THERE, IT'S ITS UNINTENDED DISCLOSURE WOULD NOT CAUSE ANY PRUB. THAT'S A RELATIVELY HIGHER BAR. COW SAY THIS IS BEING DONE IN A WAY THAT IS NOT IDENTIFIABLE, THEREFORE, YOU'RE NOT WORRYING ABOUT UNINTENDED DISCLOSURE, BUT YOU'RE MAKING A STATEMENT HERE THAT UNINTENDED DISCLOSURE COULD NOT CAUSE THEM ANY PROBLEM. IT DEPENDS ON THE CONTEXT OF THIS EXPERIMENT AND WHAT YOU MIGHT LEARN FROM THIS EXPERIMENT, WHETHER UNINTENDED DISCLOSURE COULD CAUSE PROBLEMS. >> WE'LL FIX THE EXAMPLE. OKAY. 4. NURSING HOME STAFF INTERVIEWED PATIENTS TO COMPLETE A BRIEF SELF-REPORT SCALE MEASURING MOOD AND ANXIETY AT BASELINE AND TWO WEEKS AFTER MUSIC IS PLAYED NIGHTLY IN PATIENT ROOMS ON HALF THE WARDS. ALL SUBJECTS ARE INFORMED THAT A STUDY OF THE EFFECT OF MUSIC IS PLANNED AND THE MUSIC IS PLAYED ONLY IN THE ROOMS OF THOSE PATIENT WHO AGREE TO THE INTERVENTION AND RATINGS. THE INTERVENTION INVOLVES THE MANIPULATION OF THE SUBJECTS' ENVIRONMENT AND THE COLLECTION OF DATA USING A SELF-REPORT MEASURE OF MOOD AND ANXIETY. THE INTERVENTION IS BENIGN AND THE METHOD OF COLLECTING DATA ARE CONSISTENT WITH THE EXEMPTION CRITERIA. CONSIDERING THE NATURE OF THE STUDY, THE PLAYING OF BACKGROUND MUSIC, THE DURATION OF EXPOSURE DOES NOT ALTER THE FUNDAMENTALLY BENIGN NATURE OF THE INTERVENTION. NONETHELESS, IT WOULD NOT BE CONSIDERED BRIEF. THE STUDY WOULD NOT MEET THE REQUIREMENTS FOR EXEMPTION. OKAY. HEALTHY ADUMENT SUBJECTS ARE ASKED TO TAKE PART IN AN HOUR LONG ASSESSMENT OF MEMORY, ATTENTION AND INFORMATION PROCESSING. SPEED BEFORE AND AFTER ONE HOUR OF COGNITIVE ENHANCEMENT EXERCISE USING SPECIFICALLY DESIGNED COMPUTER SOFTWARE. THE PROCEDURES ARE CONDUCTED DURING A SINGLE VISIT AND SUBJECTS ARE ENCOURAGED TO TAKE BREAKS WHEN DESIRED. THE INTERVENTION IN THIS EXAMPLE REQUIRES HEALTHY ADULT SUBJECTS TO TAKE PART IN A THREE-HOUR RESEARCH STUDY WITH NO PERSONAL BENEFIT, ONE NOT LIKELY TO BE EXPERIENCED AS BURDENSOME AND NOT LIKELY TO INTRODUCE HARM OF ANY KIND. WHILE IRB REVIEW IS UNLIKELY TO CAUSE ADDITIONAL PROTECTIONS THE INTERVENTION WOULD NOT BE CONSIDERED TO BE BRIEF IN DURATION AND, THEREFORE, WOULD NOT MEET THE EXEMPTION. YES. >> WOULDN'T IT MEET IT BASED ON WHAT WAS REVISED, SO IT'S LASTING ONLY A FEW HOURS, UNLESS WE'RE GOING TO DEBATE YOU WHETHER IT'S TWO OR THREE OR -- >> SO DO PEOPLE THINK THIS SHOULD MEET THE EXEMPTION? >> JUST RELATED TO THAT, JUST IN TERMS OF CLARITY, IT'S NOT CLEAR FROM THE WAY IT'S DESCRIBED, IT SOUNDS LIKE IT WOULD INITIALLY BE SAYING THE THREE HOURS WOULD HAVE BEEN MORE THAN BRIEF, WHICH GETS BACK TO THE WORDING IN THE EXEMPTION IS THAT THE BEHAVIORAL INTERVENTION IS THE THING THAT HAS TO BE BRIEF. I WOULD HAVE THOUGHT THAT'S ACTUALLY JUST THE ONE HOUR THING WHERE YOU'RE ACTUALLY HAVING THEM WATCH SOMETHING. DOING THE QUESTIONNAIRE PART OF IT ISN'T PART OF THE REGULATORY LIMITATION ON BRIEFNESS. >> WE SHOULD DEFINITELY SAY THAT EXPLICITLY IN THIS DOCUMENT THEN. IN THE INTRODUCTION EVEN. >> SO AND THAT IS THAT THE INTERVENTION AND THE ASSESSMENTS ARE SEPARATE THINGS? >> RIGHT. BECAUSE THAT COULD DRAMATICALLY CHANGE THINGS. I THINK -- NOT DRAMATICALLY. IF WE'RE STILL TALKING ABOUT WITHIN A DAY OR SOMETHING, WITHIN A 24 HOUR PERIOD, WHATEVER WE DECIDE ABOUT THAT. BUT IF THE INTERVENTION ITSELF LASTS FIVE MINUTES BUT THE QUESTIONNAIRE DOESN'T COUNT AS AN INTERVENTION AND THE QUESTIONNAIRE COULD BE AN HOUR, THAT -- I THINK -- I'M HAPPY TO HEAR YOU SAY THAT BECAUSE I LIKE MAKING THIS EXEMPTION AS PROD WAS WE CAN, BUT I WOULD NOT NECESSARILY HAVE PICKED UP ON THAT NUANCE. >> SO YOU WOULD BE SAYING -- SO YOU'RE GOING TO SAY THAT ONLY THE INTERVENTION HAS TO TAKE PLACE WITHIN A DAY, THE DATA COLLECTION CAN TAKE PLACE SEPARATE BECAUSE IT'S OVER A LONGER PERIOD OF TIME? >> I THINK WE CAN TALK ABOUT HOW LONG WE WANT TO EXTEND THAT PART. THAT WILL BE BEYOND THE TERMS OF THE REGULATION. IT SOUNDS LIKE THE REGULATION ITSELF IS NOT INTENDING TO ADDRESS SPECIFICALLY THE DATA COLLECTION PERIOD. WE CAN ADD THAT TO THE GUIDANCE AND I THINK WE PROBABLY SHOULD DO THAT. >> BECAUSE THAT INTRODUCES THE NOTION THAT YOU COULD HAVE A ONE-HOUR INTERVENTION AND FOLLOW PEOPLE FOR THREE MONTHS. >> AND I THINK THAT'S TO NANCY'S CONCERN, THAT IF WE WANT THIS TO BE PART OF THE EXEMPTION, WE DON'T WANT TO EXTEND PARTICIPATION FOR WEEKS OR EVEN A LONG NUMBER OF DAYS, BUT I DO LIKE THIS IDEA OF SPECIFYING -- IT HELPS PUT SOME CLARITY AROUND "A COUPLE OF HOURS," BECAUSE I THINK IF THERE'S AN INTERVENTION GOING ON FOR THREE HOURS, THAT'S PROBABLY DIFFERENT FROM GOING THROUGH A SURVEY AT YOUR OWN PACE, FOR EXAMPLE. >> MICHELE, CONSIDERATION OF ADDING SOMETHING ABOUT THAT TO THE EARLIER LANGUAGE? >> SO THIS IS AN INTERESTING CONVERSATION. SO THE IDEA BEING THAT THE INTERVENTION COULD TAKE FIVE MINUTES BUT THE DATA COLLECTION COULD TAKE MUCH LONGER. RIGHT? IS THAT WHAT I'M HEARING? >> ARE YOU SAYING THAT YOU'RE THINKING THAT YOU WOULD SAY THE INTERVENTION NEEDS TO BE BRIEF AND THE DATA COLLECTION NEEDS TO BE ACCOMPLISHED WITHIN A DAY? I MEAN, I'VE SORT OF -- NOW I'VE LOST TRACK OF WHERE WE ARE IN TERMS OF WHAT'S BRIEF. >> I DON'T THINK THAT WE'VE QUITE FIGURED IT OUT YET, BUT IT'S AROUND THIS IDEA ABOUT WHAT COUNTS AS A FEW HOURS. RIGHT? SO IF SOMEONE IS INTERVENING UPON YOU FOR THREE HOURS, THAT MIGHT FEEL DIRN THAN DIFFERENT THAN SOMEONE INTERVENING UPON YOU FOR FIVE MINUTES AND THEN YOU TAKE A SURVEY YOURSELF FOR TWO HOURS. OBVIOUSLY THIS IS ALL FUZZY, WE'RE GOING TO HAVE TO MAKE SOME ARBITRARY DIVIDING LINE, BUT I HAD NOT PICKED UP ON THAT NUANCE THAT IT'S THE INTERVENTION ITSELF THAT HAS TO BE BRIEF AS OPPOSED TO THE ENTIRETY OF ONE'S PARTICIPATION. AND AGAIN, I THINK WE AREN'T GOING TO WANT TO EXPAND THINGS SO FAR THAT THE PARTICIPATION ITSELF IS REALLY LONG IN DURATION, BUT IT MIGHT NOT HAVE TO BE QUITE SO BRIEF AS WE'RE WORRIED THAT THE INTERVENTION ITSELF NEEDS TO BE. >> SO JUST TO REMIND PEOPLE, THE LANGUAGE OF THE EXEMPTION IS RESEARCH INVOLVING BENIGN BEHAVIORAL INTERVENTIONS IN CONJUNCTION WITH THE COLLECTION OF INFORMATION. AND THEN IT'S ONLY THE BENIGN BEHAVIORAL INTERVENTION THAT'S QUALIFIED BY BRIEF. SO THEY ARE SEPARATE, ALTHOUGH IN CONJUNCTION CERTAINLY SUGGESTS THAT THEY'RE NOT ENTOIRLY ENTIRELY SEPARATED WHEN ONE GOES ON FOR WEEKS. >> THIS HAS ACTUALLY CHANGE MIGHT THINKING ABOUT IT SO LET'S KEEP GOING THROUGH THE EXAMPLES AND -- I'M TRYING TO FIGURE OUT -- I THINK I HEARD SOMEBODY SAY THREE WEEKS THERE. I'M TRYING TO FIGURE OUT IF YOU ACTUALLY SEPARATE IT OUT LIKE THAT, WHERE ARE WE GOING WITH IT? BUT LET'S KEEP MOVING. ELDERLY NURSING HOME RESIDENTS WHO MEET CRITERIA FOR MILD COGNITIVE IMPAIRMENT ARE ASKED TO TAKE PART IN A TWO HOUR -- ALL PROCEDURES ARE CONDUCTED ON A SINGLE DAY. IT IS NOT CLEAR THAT INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT CAN PROVIDE PROSPECTIVE AGREEMENT. IN ADDITION, WHETHER OR NOT THE PROCEDURES KE SCRIBED IN THIS EXAMPLE ARE LIKELY TO CAUSE HARM, LASTING ADVERSE IMPACT OROFENCE, A STUDY WHICH INVOLVES EIGHT HOURS OF RESEARCH TESTING IN A POPULATION OF ELDERLY COGNITIVELY IMPAIRED NURSING HOME RESIDENTS IS NOT BRIEF AND MOREOVER IS NOT CONSISTENT WITH THE INTENT OF THIS EXEMPTION CATEGORY. WHETHER PROSPECTIVE AGREEMENT BY THE SUBJECTS IS POSSIBLE WHETHER RISKS AND BURDENS ARE ADEQUATELY MINIMIZED AND WHETHER THE SPECIFIC AIMS OF THE STUDY JUSTIFY THE PURD OF RESEARCH PARTICIPATION ARE MATTERS APPROPRIATELY ADDRESSED BY EXPEDITED REVIEW. >> SO ON THIS ONE, I THINK THIS IS SUBSTANTIVE, NOT WORDSMITHING, THAT IT WOULD BE APPROPRIATE TO SAY IT WOULD NOT BE BRIEF IN ANY POPULATION BECAUSE OF THE LENGTH OF TIME. BUT -- AND THEN YOU COULD ADD, AND I THINK IT WOULD GO TO THE SECOND QUESTION THAT WE'RE GOING TO BE ADDING, THAT IN PARTICULAR IN THIS POPULATION WITH THESE CHARACTERISTICS, AND I THINK THAT'S CONSISTENT WITH WHERE WE'RE GOING WITH THE BRIEF, BUT ALSO PROVIDES AN OPPORTUNITY TO EMPHASIZE THIS ISSUE ABOUT VULNERABILITY. >> I THINK THAT'S A GOOD POINT. WE'LL ADD THAT. >> SO I'M GOING TO MUDDY THE WATERS A LITTLE BIT. BECAUSE JERRY JUST MADE A COMMENT TO ME THAT I THINK WAS REALLY ENLIGHTENING. IF YOU LOOK AT EXEMPTION 2 BASICALLY REGARDING SURVEYS AND ROUTINE EDUCATIONAL TESTING, THERE'S NO TIME LIMIT ON IT. SO IN SOME WAY THIS, IS ANOTHER WAY TO THINK OF EXEMPTION 3, IS YOU'RE ALLOWING ANYTHING THAT -- THINGS THAT WOULD BE EXEMPTIBLE BUT NOW HAVE A BENIGN BEHAVIORAL INTERVENTION WITH THEM. JUST BECAUSE IT HAS A BENIGN BEHAVIORAL INTERVENTION, IT DOESN'T KICK IT OUT OF THE EXEMPTIONS AND THE ACTUAL COLLECTION PROCEDURES WOULD BE BE -- THAT'S, I THINK, WORTH THINKING ABOUT. AT LEAST IT SEEMED TO ME TO CHANGE THE LANDSCAPE A LITTLE BIT. FOR EXAMPLE FOR THIS ONE, IT'S THE -- SO THERE'S A DIFFERENT QUESTION WHETHER WE THINK THIS SHOULD BE EXEMPT OR NOT. INDEPENDENT OF THE REGULATION. BUT IF THE SURVEY PROCEDURE HERE WOULD BE ALLOWABLE UNDER EXEMPTION 2, IF YOU WEREN'T DOING THE BENIGN BEHAVIORAL EXEMPTION INTERVENTION, IS THAT INTERVENTION SUFFICIENTLY INTRUSIVE TO MAKE IT NO LONGER EXEMPTS, EXEMPT, OR SHOULD WE INTERPRET IT THAT WAY? >> THE EXAMPLE STILL CONTAINS FOUR 1-HOUR BEHAVIORAL INTERVENTION SLOTS, WHICH IT SEEMS LIKE WE'RE KIND OF AGREED THAT WHILE THREE HOURS MIGHT BE OKAY, FOUR HOURS IS PROBABLY TOO MUCH? >> I DON'T DISAGREE WITH THAT. I JUST WANTED TO BRING UP THE ANALYSIS TALKS ABOUT EIGHT HOURS OF RESEARCH TESTING, AND MAYBE THAT'S -- IF THAT'S SOMETHING THAT WE WOULD HAVE I ALLOWED UNDER EXEMPTION 2, WE SHOULD JUST THINK OF THIS IN THAT LIGHT. >> SO THEN IS IT BEING ALLOWED UNDER 2 AND 3? >> WELL -- >> I MEAN -- >> YOU CAN'T ALLOW SOMETHING UNDER 2 THAT INVOLVES AN INTERVENTION. >> RIGHT, BUT I'M STILL HAVING TROUBLE CONNECTING THE TWO, BECAUSE THE BRIEF -- I HADN'T THOUGHT ABOUT THE INTERPRETATION, WE HADN'T DISCUSSED IT EARLIER, ABOUT SEPARATING OUT THE BENIGN INTERVENTION FROM THE DATA COLLECTION. SO LET'S -- WE'LL TALK ABOUT IT OVER LUNCH AND SEE HOW WE REFRAME THINGS. GOOD CONVERSATIONS. I THINK SOME OF THESE ARE GOING TO CHANGE BASED ON WHAT WE END UP DOING WITH SOME OF THE THINGS WE'VE OPINION TALKING ABOUT. SO 7, RECORDINGS OF BLOOD PRESSURE AND PULSE ARE OBTAINED ALONG WITH THE COLLECTION OF A IS SALIVA SPECIMEN IN A STUDY THINK LIPGING PHYSIOLOGICAL AROUSAL, THE PROCEDURES LAST 75 MINUTES. THE COMPUTER GAME INTERVENTION IS BRIEF AND IS LIKELY TO BEBENIGN DEPENDING ON THE CONTENT OF THE GAMES BUT THE COLLECTION OF BLOOD PRESSURE, PULSE AND SERUM CORTISOL DATA WOULD BE CONSIDERED MEDICAL INTERVENTIONS AND SO NOT CONSISTENT WITH THE EXEMPTION. IN ADDITION, THE DATA COLLECTION PROPOSED IS NOT CONSISTENT WITH THE EXEMPTION WHICH REQUIRES DATA COLLECTION BY ORAL OR WRITTEN RESPONSE ONLY. THIS EXAMPLE WOULD NOT BE EXEMPT UNDER THIS CATEGORY. COMMENTS? OKAY. 8. COLLEGE STUDENTS TAKE PART IN A STUDY INVOLVING COMPUTER SIMULATION OF AN ONLINE DATING APP IN WHICH EACH STUDENT IS ULTIMATELY REJECTED BY A PROSPECTIVE DATE WHO, IN FACT, IS A MEMBER OF THE STUDY TEAM. THE STUDENTS ARE ASKED TO AGREE TO THE RESEARCH AND ARE TOLD THAT ASPECTS OF THE RESEARCH GOALS AND METHODS ARE BEING WITHHELD FROM THEM UNTIL AFTER THEIR PARTICIPATION. WHILE THE STUDENTS AGREE TO TAKE PART IN THIS STUDY AND ARE TOLD THAT DECEPTION IS INVOLVED, THE AIM OF THE INTERVENTION IS TO SIMULATE REJECTION AND ELICIT EMOTIONAL RESPONSES. WHILE SOME MAY ASSUME THEIR EXPERIENCE OF REJECTION WAS AN EXPERIMENTAL MANIPULATION, MANY WILL LIKELY REACT TO THE INTERVENTION AND TO THE POST STUDY DEBRIEF WITH SHAME, EMBARRASSMENT AND HUMILIATION. THIS EXAMPLE WOULD THEREFORE NOT MEET THE EXEMPTION CRITERIA. 9, A STUDY SEEKS TO MEASURE HOW INDIVIDUALS ATTEND TO VISUAL STIMULI WITH DIFFERENT EMOTIONAL MEANING. EACH SUBJECT PLACES HIS HEAD ON A CHIN REST IN FRONT OF A COMPUTER MONITOR WHILE BEING SHOWN A MATRIX OF 6 MAGAZINE PHOTOS OF PEOPLE WITH MILDLY SAD, HAPPY, SURPRISED, FRIGHTENED AND WORRIED EXPRESSIONS. SUBJECT EYE MOVEMENTS/FIXATION ARE RECORDED BY A DIGITAL CAMERA. NO IDENTIFYING DATA IS RECORDED. THE INTERVENTION IS BRIEF, DATA COLLECTION INVOLVES ONLY VISUAL RECORDING. GIVEN THE DESCRIPTION OF THE PHOTOS, THE INTERVENTION IS NOT LIKELY TO BE HARMFUL, FRIGHTENING, LIKELY TO HAVE A SIGNIFICANT ADVERSE LASTING IMPACT OR BE CONSIDERED OFFENSIVE. THE EXAMPLE IS CONSISTENT WITH THE EXEMPTION UNDER THIS CATEGORY. OKAY? LAST ONE. CLIENTS AT A HEALTH CLUB ARE ASKED TO PARTICIPATE IN A STUDY LOOKING AT THE IMPACT OF WALKING ON LOWERING BLOOD PRESSURE. CLIENTS ARE PROVIDED WITH A FREE FITBIT AND THEN ASKED TO COME TO THE CLUB EVERY OTHER DAY TO HAVE A READING TAKEN OF THEIR DAILY STEPS AS RECORDED ON THE FITBIT AND OF THEIR BLOOD PRESSURE. THIS WOULD NOT MEET THE EXEMPTION BECAUSE THE DATA RECORDED BY THE FITBIT DOES NOT -- IS NOT CONSISTENT WITH THE REQUIREMENT THAT DATA MAY ONLY BE COLLECTED USING VERBAL OR WRITTEN RESPONSES OR AUDIOVISUAL RECORDING. IT WOULD ALSO NOT BE BRIEF IN DURATION. >> SO WHEN I READ THIS THIS TIME THROUGH, IT SEEMED TO ME A LITTLE OVERDETERMINED BECAUSE OF THE NUMBER OF WAYS IN WHICH IT DOESN'T FIT, AND I ALSO COULDN'T REALLY SEE WHAT'S THE BEHAVIORAL INTERVENTION HERE? I MEAN, IT LOOKS LIKE SOMETHING THAT WOULD BE EXPEDITED BUT IT DOESN'T SEEM TO HAVE A BEHAVIORAL INTERVENTION AS PART OF IT. >> RIGHT, BECAUSE THE WALKING IS PHYSICAL, NOT BEHAVIORAL. >> AND WHAT'S BEING MEASURED ISN'T BEHAVIORAL EITHER. >> RIGHT. >> SO WE MIGHT BE ABLE TO -- >> LET'S LOOK AT THIS AGAIN. >> OKAY. >> OR DELETE. >> YOU CAN ALTER THIS, AND CHANGE THE EXAMPLE SO THAT THEY'RE GIVEN THE FITBIT AND YOU'LL SEE IF PEOPLE INCREASE THEIR PHYSICAL ACTIVITY AFTER THEY GET THE FITBIT AND THEN YOU HAVE A BEHAVIORAL INTERVENTION LIKE THAT. >> THEN THE DATA STILL ISN'T -- IT STILL DOESN'T MEET IT. >> BUT IT GIVES YOU A BEHAVIORAL COMPONENT TO YOUR RESEARCH. >> GOT IT. OKAY. SO I THINK THAT SOME OF US HAVE OUR WORK CUT OUT FOR US. IT'S INTERESTING TO GO THROUGH THESE CONVERSATIONS AND SEE DIFFERENT ISSUES ARISE AT DIFFERENT TIMES IN THE CONVERSATIONS. SO DOES ANYBODY HAVE ANY OTHER COMMENTS ON THIS? SO JULIA, IN TERMS OF OUR TIMING FOR THIS MEETING, SOME OF US WILL SIT DOWN AT LUP CH AT LUNCHTIME AND WORK THROUGH SOME OF THE CHANGES AND THEN THERE WILL BE AN OPPORTUNITY TO COME BACK TO THE GROUP. ALL RIGHT. GOOD. >> THANK YOU. >> I THINK I'LL PASS THE BATON TO THE NEXT PERSON. >> SO WE'RE ACTUALLY 20 MINUTES EARLY FOR OUR BREAK. BUT WHY DON'T WE TAKE A 15-MINUTE BREAK NOW, COME BACK IN 20 MINUTES, THAT'S APPROXIMATELY 20 OF 11:00. AND WE'LL MOVE ON TO THE NEXT TOPIC, WHICH WILL BE THE EXPEDITED REVIEW LIST. THANK YOU. OUR NEXT TOPIC IS THE EXPEDITED REVIEW LIST. DAVID. >> THANK YOU, STEVE. GOOD MORNING, EVERYBODY. FEELS LIKE WE WERE JUST GOING THROUGH THIS NOT LONG AGO, BUT REALLY HAPPY TO HAVE IT BACK IN FRONT OF YOU, AND THIS HAS BEEN A LOT OF WORK SO IT LOOKS QUITE DIFFERENT THAN THE LAST TIME YOU SAW IT. I WOULD HAVE SHOWED YOU THE TRACK VERSION BUT YOU WOULD STRUGGLE TO FIND REMNANTS OF A LOT OF THE OLD THINGS IN THERE AND I THOUGHT IT WOULD MAKE MORE SENSE IF WE WENT AT IT FROM THE CLEAN VERSION THAT WE HAVE. JUST AS A BIT OF BACKGROUND, PARTICULARLY FOR THE NEW MEMBERS WHO WEREN'T AT THE LAST MEETING, THE SUBCOMMITTEE WAS ASKED TO TAKE A STAB AT WHAT THE CATEGORIES MIGHT LOOK LIKE. THE LIST DOES DATE BACK TO THE 1990s SO IT IS RIPE FOR REVISION. SOME OF THE PARAMETERS WE HAD PUT AROUND US WERE, OF COURSE, THAT IT HAD TO BE NO MORE THAN MINIMAL RISK RESEARCH, THE REGULATIONS ARE NO LONGER QUITE EXPLICIT ON THAT POINT BUT OHRP HAS BEEN, SO IF YOU SEE LOT OF REFERENCES TO ENSURING THAT IT'S MINIMAL RISK, THAT'S THE REASON FOR SOME OF THAT LANGUAGE. AND THAT THE PRESUMPTION WOULD BE THAT THINGS ON THIS LIST ARE MINIMAL RISK, SO WE'VE TRIED TO WRITE THEM AS NARROWLY AS POSSIBLE OR PROVIDE FAIRLY REVIEWER THAT WAS TRYING TO DECIDE IF SOMETHING DID FIT ON THE LIST SHOULD HAVE A PRETTY CLEAR INDICATION WHETHER IT DOES OR DOES NOT, EVEN THOUGH THEY'RE STILL REQUIRED TO MAKE SURE THAT THE ACTIVITY AS DESCRIBED IN THE PROPOSED RESEARCH IS MINIMAL RISK. SO IT'S GONE THROUGH QUITE A FEW REVISIONS OVER THE LAST HOWEVER MANY MONTHS WE'VE BEEN WORKING ON IT, AND THIS DRAFT TRIES TO INCORPORATE THE FEEDBACK THAT WE'VE RECEIVEED FROM BOTH ALL OF YOU ON THE SACHRP AS WELL AS THE SUBCOMMITTEE MEMBER, AND WE'VE REALLY APPRECIATED THAT ENGAGEMENT AS WELL AS ENGAGEMENT BY THE FOLKS AT OHRP WHO HAVE BEEN HELPFUL IN CHIMING IN WHEN THEY THOUGHT WE WERE SORT OF HEADED IN A DIRECTION THAT MIGHT NOT BE SUPPORTABLE. MY HOPE IS THAT WE'LL SORT OF GET THROUGH THIS TODAY AND IF WE HAVE TO BRING IT BACK TOMORROW WITH ADDITIONAL EDITS, WE CAN CERTAINLY DO THAT. ALSO I GUESS AS A REMINDER, BECAUSE SOMETIMES THIS QUESTION HAS COME UP BOTH WITHIN THE SUBCOMMITTEE AND AT THE LAST MEETING HERE IN TERMS OF THE REGULATORY PROCESS FOR THIS, OBVIOUSLY ANY PRODUCT THAT WE -- IF SACHRP WAS TO END UP ENDORSING THIS BY THE END OF MEETING, IT CLEARLY WOULD HAVE TO GO THROUGH A REGULATORY PATHWAY THAT OHRP WOULD LEAD, SO WHAT YOU SEE HERE IS NOT -- PROBABLY NOT GOING TO BE WHAT WOULD APPEAR IN THE REGULATIONS ANY TIME SOON, EVEN WITH SACHRP'S ENDORSEMENT. SO I THINK WITH THE SAME ENCOURAGEMENT AS MICHELE STARTED HER TALK, TO THE EXTENT THAT WE CAN AVOID GETTING TOO FAR INTO THE WEEDS, ALTHOUGH I THINK SOMETIMES IT WILL BE NECESSARY TO BE VERY CAREFUL AND PRECISE WITH THE WORDS HERE, THIS ISN'T THE LAST SAY ON WHAT THIS WOULD LOOK LIKE IN ITS FINISHED PRODUCT. SO I'LL JUST ENCOURAGE YOU TO KEEP MOVING FORWARD BUT I ALSO DO RECOGNIZE THAT IT WILL REQUIRE QUITE A BIT OF TWEAKING AS WE GO THROUGH, PARTICULARLY BECAUSE SOME OF THESE PROPOSED CATEGORIES HAD SOME SIGNIFICANT REWRITINGS FROM THE LAST TIME OR WEREN'T HERE LAST TIME BASED ON FEEDBACK FROM SACHRP OR AS THE SUBCOMMITTEE CONTINUED TO THINK IT THROUGH. IN TERMS OF THE STRUCTURE, IT CONTINUES TO LOOK VERY MUCH IN THE BROAD PICTURE LIKE THE OLD EXPEDITED REVIEW LIST THAT BEGINS WITH THE LIST OF CATEGORIES THAT WOULD APPLY TO INITIAL REVIEW OF RESEARCH AND THEN HAS A FEW CATEGORIES AT THE END THAT ARE SIMILAR IN SOME WAYS TO THE CURRENT CONTINUING REVIEW CATEGORIES FOR EXPEDITED REVIEW. TO THE EXTENT POSSIBLE, I'VE TRIED TO RETAIN THE STRUCTURE IN TERMS OF WHERE THINGS APPEAR ON THAT LIST THAT WAS SOMETHING BROUGHT UP AT THE LAST SACHRP, BUT AS THE LIST HAS SORT OF EVOLVED AND CHANGED AND SOME OF THE OLD CATEGORYS HAVE LITERALLY BEEN PULLED INTO TWO PIECES, IT WAS NOT POSSIBLE TO ROW RETAIN A LOGICAL FLOW AND FORCE IT INTO THAT SAME THING, BUT GENERALLY IT FOLLOWS THE SAME STRUCTURE ORDER IN TERMS OF WHERE THE CATEGORIES APPEAR AS THE OLD ONE WITH THE EXCEPTION OF NEW CATEGORIES OR NOW SEPARATED CAT DPRIS. CATEGORIES. SO BEFORE WE GET STARTED, I'LL JUST SAY THAT IT AGAIN BEGIN WITH A PAGE OR SO OF INTRODUCTION, AND IT INCLUDES THE ADMONITIONS FOR MAKING SURE IT'S MINIMAL RISK AND TALKS ABOUT THE SCOPE OF IT, AND EVEN THIS HAD QUITE A BIT OF BACK AND FORTH, SO I'M NOT GOING TO RUSH US THROUGH THAT. I'LL JUST GO AHEAD, I GUESS, AND OPEN IT UP AND SAY I'D LIKE FEEDBACK ON THIS FRONT MATTER BEFORE WE GET TO THE LIST ITSELF. SO WITH THAT, WE'VE GOT A FEW PARAGRAPHS FROM LINE 35 TO 15 LINES 5 TO 1 5 THAT FALL UNDER INTRODUCTION. COMMENTS OR QUESTIONS ABOUT THOSE? LINES 5 TO 15. AND THEN STARTING AT LINE 16, WE HAVE A SECTION THAT TALKS ABOUT THE EVALUATION OF THE STUDY, AND THIS WAS REALLY AT THE ENCOURAGEMENT OF OHRP THAT WANTS TO BE SURE THAT IT'S CRYSTAL CLEAR THAT THE PERSON -- THE IRB MEMBER THAT'S DOING THIS REVIEW HAS TO BE MINIMAL RISK AND THAT THEY SHOULD BE PART OF THEIR EVALUATION SHOULD BE DECIDING THAT THE RESEARCH THAT'S PROPOSED IS INDEED NO GREATER THAN MINIMAL RISK OR NO MORE THAN MINIMAL RISK. QUESTIONS OR COMMENTS FROM LINE 17 TO 34? >> SO DO WE WANT WORDSMITHING? >> ONLY GOOD WORDSMITHING. >> THERE AGAIN, THEY ARE WORDS WITH IMPLICATION. SO ACTUALLY GOING BACK TO 15, CARRIED OUT BY THE CHAIRPERSON OR BY ONE OR MORE EXPERIENCED REVIEWER AS DESIGNATED BY THE CHAIRPERSON. I THINK THAT INVITES WHAT DOES IT MEAN BY EXPERIENCED, WHAT IS THE QUALIFICATION REQUIRED. I THINK TRADITIONALLY, IT'S THE CHAIR'S ROLE TO DESIGNATE SUITABLE REVIEWERS. I'M NOT SURE WE WANT TO EXPLICITLY SAY EXPERIENCED. >> THAT'S FROM THE REGULATORY LANGUAGE. I MEAN, THE OLD REGULATORY LANGUAGE. >> WE CAN CHANGE IT. >> WE COULD. I DON'T REMEMBER WHAT IT SAYS AT 110 RIGHT NOW OR WHAT IT SAYS AT 110 -- >> OH, IT'S IN THE REG LANGUAGE. >> THAT'S WHAT I MEANT. IT'S IN THE 45, 46. I'M NOT SAYING I DISAGREE. SO ANY OTHER COMMENTS UP TO -- WE'RE NOW AT LINE 34? >> BETWEEN 17 AND 34 IS UP FOR GRABS RIGHT NOW. ALL RIGHT. THIS IS INCREDIBLE. I'M GOING TO KEEP SCROLLING ALONG THEN. THE APPLICABILITY SEC SHUNL, SO I'LL JUST SAY THAT SOME OF THIS, THE NUMBERS, I EITHER LOST THE TRACKING OR ACCIDENTLY REVERTED TO THE OLD ONE. OBVIOUSLY THESE NUMBERS WILL BE CHANGED, CATEGORIES 1 THROUGH WHATEVER WILL APPLY TO INITIAL REVIEW, AND THEN CATEGORY WHATEVER WILL APPLY TO THE PREVIOUSLY CONSIDERING. SO I KNOW THAT NEEDS TO BE FIXED, I DON'T KNOW HOW THAT SLIPPED THROUGH, IT'S JUST BEEN A TRACKING ERROR ON MY PART BUT I REALIZED THOSE NUMBERS ARE INCORRECT. OTHERWISE, THE APPLICABILITY IS A COMBINATION OF THE OLD AND THE NEW IN TERMS OF WHAT THE APPLICABILITY OF THIS LIST IS. AGAIN, IT HAS TO BE MINIMAL RISK THAT THE CAT IMRIS CATEGORIES APPLY EXCEPT WHERE NOTED, HAS TO FIT INTO THOSE CATEGORY, THEN E, EXAMPLES ARE INTENDED TO SUGGEST THE TYPES OF RESEARCH ACTIVITIES AND PROCEDURES THAT POSE NO MORE THAN MINIMAL RISK AND MAY NOT BE APPROVED USING EXPEDITED PROCEDURES. THAT MIGHT BE SLIGHTLY AT ODDS WITH WHAT I SAID. IF THE GOAL IS TO MAKE SURE THAT EXPEDITED REVIEW IS USED APPROPRIATELY AND TO SOME EXTENT THERE'S A DESIRE TO SEE A SLIGHT BROADENING OF THE CATEGORIES, PART OF OUR CHALLENGE WAS TO BRING THINGS TO THE TABLE THAT RIGHT NOW GO TO THE FULL BOARD WHERE THE CONSENSUS AT LEAST AMONG THE SUBCOMMITTEES WAS THAT'S A WASTE OF FULL BOARD TIME, WE WANT TO DO THAT. THERE'S ALWAYS THE CONCERN THAT THE EXAMPLES, YOU KNOW, WE DON'T SAY THESE ARE THE ONLY THINGS THAT CAN BE DONE. WE THE SUBCOMMITTEE MEMBERS THOUGHT THERE SHOULD BE SOME REASONABLE -- IF IT'S AN EXPERIENCED REVIEWER DOING THIS, THAT THERE SHOULD BE SOME REASONABLE DISCRETION FOR THEM TO SAY WELL, MAYBE THAT'S AN OVAL PEG FOR A ROUND HOLE, BUT WE THINK IT MAPS ON TO THE EXAMPLES AND IT'S APPROPRIATE. SO I KNOW THOSE TWO STATEMENTS I SAID ARE SLIGHTLY AT ODDS, BUT WE STILL -- THE CONSENSUS FOR THE SUBCOMMITTEES IS THAT EXAMPLES ARE EXAMPLES AND NOT A DEFINITIVE LIST. LETTER F, CAN'T BE USED FOR CLASSIFIED RESEARCH, AND THEN LETTER IM. LETTER G JUST REFLECTS THE NEW COMMON RULE, CONTINUING REVIEW IS NOT REQUIRED FOR RESEARCH ELIGIBLE FOR AND APPROVED BY EXPEDITED REVIEW, AND THAT'S THE CITATION FOR THAT NEW REQUIREMENT. SO I THINK IT WAS MENTIONED EARLIER BY STEPHEN IN DISCUSSING BENIGN BEHAVIORAL INTERVENTIONS, THAT EXPEDITED REVIEW STUDIES ARE ALSO SORT OF ONCE AND DONE FROM AN IRB PERSPECTIVE IN TERMS OF THAT INITIAL REVIEW. OBVIOUSLY CHANGES WOULD HAVE TO COME BACK, THINGS OF THAT NATURE, BUT IT WOULD BE NO LORNGER IN LONGER IN THE CONTINUING REVIEW LOOP. YES. >> VERY MINOR WORDSMITH. IN A, DON'T YOU WANT TO SAY "NO MORE THAN MINIMAL RISK" VERSUS THE STUDY HAS TO BE MINIMAL RISK? >> YEAH, I THINK JULIA HAS CHIDED ME ON THIS PF. IS IT NO GREATER THAN MINIMAL THE PREFERRED TERM, JULIA? >> WHATEVER. >> WELL, YEAH, YOU'RE RIGHT. >> THEN UNDER G, DOESN'T THE IRB DETERMINE OTHERWISE AND DOCUMENTS THE RATIONALE, AREN'T THEY REQUIRED TO DOCUMENT THAT RATIONALE? >> THAT IS CORRECT, I BELIEVE THAT IS WHAT IS REQUIRED BY 109. WE HAD THAT IN AN EARLIER VERSION AND THERE WAS SOME CONCERN ABOUT IT, SO IT WAS PULLED BACK OUT, BUT THAT INDEED IS THE REQUIREMENT, THAT'S PART OF THAT PUSH TO MAKE SURE THAT INSTITUTIONS OR IRBs ARE APPLYING -- ARE USING THE EXPEDITED REVIEW LIST. REID? >> THIS ALL SUGGESTS THAT EXPEDITED RESEARCH IS UNLIMITED AS TO LENGTH OF TIME. IS THAT A FAIR -- >> I WOULD SAY THAT THAT IS FAIR. AND IN FACT, THERE WAS A NEW CATEGORY FOR NON-EXEMPT BENIGN BEHAVIORAL INTERVENTIONS. ONE OF THE THINGS IT SAYS IS BECAUSE IT'S NOT BRIEF IN DURATION. OKAY. SO THEN WE'LL JUMP INTO THE CATEGORIES AND AGAIN FOR THOSE OF YOU THAT HAVE BEEN EITHER THROUGH SERVICE ON THE SUBCOMMITTEES OR JUST REMEMBERING FROM THE LAST MEETING, HOPEFULLY UNLIKE THE CATEGORIES ABOVE, I DIDN'T MAKE TOO MANY MISTAKES WITH THE ACCEPTING OF REVISIONS AND CHANGES. SO CATEGORY ONE IS A REVISED VERSION OF THE EXISTING CATEGORY ONE, AND WE'VE TRIED TO DO SOME REFINEMENT. SO WHAT THE SUBCOMMITTEES SETTLED ON IS THAT FOR 1A, THIS WOULD BE RESEARCH INVOLVING THE USE OF OVER THE COUNTER DRUGS WHEN USED WITHIN THEIR APPROVED INDICATIONS AN DOSAGES AND EXEMPT FROM THE IND REQUIREMENTS. SO AS WE WERE TRYING TO FIGURE OUT WHAT WE THOUGHT WOULD BE ACCEPTABLE FOR EXPEDITING, THIS IS SORT OF WHAT WE NARROWED IT DOWN TO. I KNOW WE'VE GOT FOLKS FROM FDA IN THE ROOM AND WE'RE REALLY TALKING ABOUT THINGS THAT ARE SORT OF ON THE CUSP OF CLINICAL INVESTIGATION SO IF THEY'VE GOT COMMENTS ON THAT, I WELCOME THAT AS WELL. THEN 1B WAS RESEARCH INVOLVING THE USE OF MEDICAL DEVICES EXEMPT FROM THE IDE REQUIREMENTS AT 812. AND WE TALKED ABOUT ELIMINATING THAT ONE, BUT WE -- BECAUSE WE WERE HAVING DIFFICULTY COMING UP WITH GOOD EXAMPLE, BUT DECIDED TO LEAVE IT THERE BECAUSE WITH THE ERA OF MEDICAL APPS AND THINGS, WE DIDN'T KNOW WHERE THAT WOULD TAKE US IN THE FUTURE AND WE'D HATE TO LOSE THAT ABILITY TO EXPEDITE. YES. >> SO IN A, YOU HAVE THE FACT THAT IT'S OVER THE COUNTER DRUGS APPROVED AND IT'S FOR THEIR APPROVED INDICATIONS AND DOSAGES. IN B, IT'S THE USE OF MEDICAL KE VICES THAT ARE EXEMPT BUT IS THERE ANY CRITERIA THERE FOR APPROVED INDICATIONS OR ANY CRITERIA INVOLVING USE? THIS IS NOT MY FIELD. I JUST LOOKED AT THEM AND SAID THESE DON'T LOOK PARALLEL TO ME, THERE'S SOMETHING MISSING. IT IS INTENTIONALLY MISSING AND SHOULD IT NOT BE THERE? >> I WOULD SAY IT'S INTENTIONALLY MISSING. THE DRUG AND DEVICE REGULATIONS ARE SO DIFFERENT THAT WE STRUGGLE TO SORT OF COME UP WITH SIMILAR LANGUAGE THAT WE FELT COMFORTABLE USING ACROSS BOTH -- THE PATHWAYS FOR DEVICES ARE MORE DIVERSE THAN ON THE DRUG SIDE. >> [INAUDIBLE] >> IT WOULD HAVE TO BE EXEMPT FROM THE ICHT FROM THE IDE REQUIREMENTS, SO YOU WOULDN'T BE TAKING SOMETHING AND SAY WE CAN EXPEDITE IT. THIS NARROWING OF SAYING IT HAS TO BE EXEMPT FROM THE IDE REQUIREMENTS REALLY, IF YOU FOUND DEVICES THAT FIT INTO THAT, WE WERE COMFORTABLE SAYING IT WOULD BE EXPEDITED. >> SO I WOULD SUGGEST IN A, SAYING INDICAIONS -- CONTRAINDICATIONS AND DOSAGES. FOR EXAMPLE, ASPIRIN WOULD BE CONTRAINDICATED IN SOMEONE TAKING WARFRIN. >> YOU MIGHT ALSO ADD "POPULATIONS" THERE, SORT OF PARALLEL WITH THE IND EXEMPTION REQUIREMENTS. >> I DON'T KNOW THAT YOU NEED TO ADD ALL OF THE SPECIFICITY BECAUSE IT'S INCLUDED IN THE EXEMPTION CRITERIA. TO BE IND EXEMPT, YOU HAVE TO BE WITHIN THAT LABEL, SAME DOSE, SAME POPULATION, NOT A NEW ROUTE OF ADMINISTRATION, SO ONCE YOU START DOWN THAT PATH, I THINK YOU WOULD HAVE TO ADD OTHER THINGS LIKE NOT THAT DIFFERENT ROUTE OF ADMINISTRATION, YOU'RE NOT INCREASING THE RISK TO THE SUBJECT, SO I THINK YOU'RE SAFER IF YOU JUST SAY EXEMPT FROM THE IND REQUIREMENTS. BUT I THINK FDA WOULD STILL HAVE SOME CONCERNS, GIVEN THAT THIS LIST NOW IS SUPPOSED TO BE THAT THE KEY FAULT IS DEFAULT IS THAT IT'S MINI MAL RISK, EVEN FOR SOME OF THE OVERTHE COUNTER MEDICATION, IF YOU TAKE TYLENOL AND COMPARE IT TO ACETAMINOPHEN, PEOPLE DON'T NECESSARILY CONSIDER THAT TO BE MINIMAL RISK JUST BECAUSE THEY'RE APPROVED EVEN IF THEY ARE USED WITHIN THEIR LABEL AND EVERYTHING ELSE. AND TO ADDRESS SANDRA'S QUESTION, THE REASON A AND B ARE DIFFERENT IS THE EXEMPTIONS FOR AN IND ARE APPROVED DRUGS THAT ARE ON LABEL AND THE OTHER CRITERIA. FOR DEVICES, THERE ARE SOME THINGS THAT REX EMENT BECAUSE THEY'RE APPROVED, LIKE IF YOU TAKE A PMA APPROVED DEFIBRILLATOR AND YOU USE IT ON LABEL, YOU DON'T NEED AN IDE FOR THAT, BUT AS STEPHEN WAS DESCRIBING, THAT WOULDN'T BE A MINIMAL RISK STUDY, EVEN THOUGH IT IS APPROVED. BUT YOU COULD HAVE SOMETHING THAT'S NOT APPROVED LIKE AN IN VITRO DIAGNOSTIC THAT COULD ALSO BE EXEMPT. THE EXEMPTIONS IN 812, WHAT I'M TRYING TO SAY, INCLUDING BOTH THINGS THAT ARE APPROVED AND BEING USED OP LABEL ON LABEL AND ALSO IN ININVESTIGATIONAL, SO THAT'S WHY THERE'S NOT THAT PARALLEL BETWEEN A AND B. >> I WAS CURIOUS ABOUT SANDRA'S POINT TO JOANNE. SO ARE YOU SAYING THAT THAT ADDED THING IN A, WHICH IS SORT OF GETTING TO THIS NOTION THAT JUST BECAUSE YOU'RE USING SOMETHING ACCORDING TO ITS CLINICAL INDICATION THIS, IS FETTING GETTING INTO ISSUES WITH STANDARD OF CARE COMPARISONS, THAT TREATMENT COULD IMPOSE DIFFERENT SORTS OF SIDE EFFECTS AND, THEREFORE, RANDOMIZING SOMEBODY BETWEEN THEM CAN RAISE LEGITIMATE ISSUES, EVEN THOUGH IT COULD STILL BE EXEMPT FROM IND OR OTHER THINGS. SO UNDER THE DEVICE RULES, LET'S ASSUME YOU'RE DOING A STUDY WHICH IS RANDOMIZING PEOPLE TO GETTING ONE OF TWO DIFFERENT DEVICE, THEY DEVICE, THEY WOULD BOTH BE USED ACCORDING TO THE MARKETING INDICATIONS BUT LET'S ASSUME THERE ARE DIFFERENT -- DIFFERENCES BETWEEN THE RISK PROFILES CONSTITUTE A MORE THAN MINIMAL RISK DIFFERENCE. YOU DON'T NEED THE ADDITIONAL SENTENCE IN B FOR WHAT REASON? THERE ISN'T A POSSIBILITY THAT -- >> I THINK B IS BROAD. I MEAN, BECAUSE ANYTHING THAT'S EXEMPT UNDER THERE, THIS ALL GOES BACK TO THE CHANGE IN THIS REGULATION THAT SAYS MORE OR LESS YOU'RE ASSUMED TO BE MINIMAL RISK IF YOU'RE ON THIS LIST. BEFORE, THE WAY WE INTERPRETED IT, IT WAS IF YOU'RE ON THE LIST, AND WHEN YOU MAKE THE DETERMINATION THAT IT'S MINIMAL RISK, WHERE NOW THERE'S MORE OF THAT PRESUMPTION, SOMEBODY HAS TO LOOK AT IT AND SAY IT'S NOT MORE THAN MINIMAL RISK BUT I THOUGHT IN THE COMMON RULE REVISION, THERE WAS MORE OF A SHIFT TOWARDS IF YOU'RE ON THIS LIST, YOU'RE PRETTY MUCH GOING TO BE IN MINIMAL RISK. >> OKAY. SO THIS GETS BACK TO WHY SHOULD SHOULDN'T YOU BE ADDING IN B THE WAY SANDRA WAS SUGGESTING IT, A SENTENCE THAT IS PICK UP WHAT WAS IN THE PARENTHETICAL SENTENCE AT THE END OF A, NAMELY, IF YOU'RE DOING A STUDY, THAT -- AGAIN, I DON'T KNOW THE FDA RULES, BUT I TAKE IT YOU CERTAINLY CAN MEET THE BODY OF PART B IF YOU'RE DOING A STUDY COMPARING TWO DEVICES AND BOTH DEVICES ARE BEING USED ACCORDING TO OUR LABELING INDICATION BUT THE STUDY ACTUALLY RANDOMIZES A PERSON TO ONE OR ANOTHER OF THE DEVICES AND AGAIN, ASSUMING THAT THERE ARE DIFFERENT RISK PROFILES FOR THE TWO DEVICES, WHY WOULDN'T YOU WANT TO NARROW THE SCOPE OF THE EXEMPTION OR THE EX-PE EXPEDITING, WHATEVER IT IS, BECAUSE YOU MAY IN FACT HAVE A STUDY THAT INVOLVES MORE THAN A MINIMAL RISK DIFFERENCE BETWEEN THE TWO ARMS AND PRESUMABLY YOU WOULDN'T WANT TO EX-PE TIGHT THAT STUDY. SO IT SOUNDS LIKE THAT ISN'T ALREADY BUILT IN TO B, AND YET IT IS BUILT IN TO A BY THAT ADDITIONAL SENTENCE IN A. AGAIN WE'RE CONSTRUCTING, PARTICULARLY US A NOTE, THERE IS A DEFAULT, ASSUMING THAT A STUDY IS DEEMED TO BE MINIMAL RISK UNLESS THE REVIEWER DETERMINES OTHERWISE. PRESUMABLY THAT'S NOT THE KIND OF STUDY WE WANT JUST GOING TO ONE REVIEWER, WE ACTUALLY WANT THAT TO DW TO GO TO A FULL BOARD REVIEW. >> I GUESS I'M NOT AGREEING THAT IT'S BUILT IN TO A. ALL THAT A IS SAYING IS IT'S EXEMPT FROM THE IND REQUIREMENTS THAT WE'RE NOT NECESSARILY SAYING IT'S MINIMAL RISK, SO IT'S THE SAME AS IN B, IT'S EXEMPT FROM AN IDE BUT OUR CONCERN AT FDA IS WHETHER OR NOT THAT WOULD BE MINIMAL RISK. SO YOU HAVE TO -- IT'S -- I THINK IT'S SOMEWHAT CASE BY CASE. >> SO AN EXCELLENT POINT, I WAS INCORRECTLY LOOKING AT THE OLD LANGUAGE WHERE THE OLD LANGUAGE ACTUALLY DID HAVE A PARENTHETICAL, "NO RESEARCH -- THIS WAS IN A -- RESEARCH IN MARKETED DRUGS THAT SIGNIFICANTLY INCREASES THE RISK OR DECREASES THE ACCEPTABILITY OF RISK ASSOCIATED WITH USE OF THE PRODUCT IS NOT ELIGIBLE FOR -- REVIEW. SO MAYBE THIS IS A QUESTION FOR DAVID AND THE GROUP, WHY EVEN IN A, THE QUESTION IS COULD YOU HAVE TWO OVER THE COUNTER DRUGS THAT HAVE DIRN RISK PROFILES THAT TREAT THE SAME CONDITION. >> OR MAYBE THAT PARENTHETICAL SHOULD GO BACK IN TO THE STEM OF 1. >> THAT WAS WHAT I WOULD BE RAISING THE QUESTION, THEN THE QUESTION WOULD BE EVEN FOR B, OR IF IT'S IN THE STEM FOR 1, IT WOULD COVER BOTH A AND B. >> THE MULTIPLE ONCOLOGY STUDIES WE DO WHERE WE GIVE TWO APPROVEED COMPARATIVE EFFECTIVENESS STUDIES OF DIFFERENT CHEMOTHERAPY AGENTS. THEY HAVE TWO DIFFERENT RISK PROFILES, SO INDEED, WE WOULD CONSIDER THAT TO BE GREATER THAN MINIMAL RISK BECAUSE YES, EVEN THOUGH A WOULD SAY IT'S MARKETED, IT'S COMMERCIALLY AVAILABLE, IT'S USED WITHIN ITS APPROVED INDICATION IN DOSAGE, THE RISK PROFILES ARE DIFFERENT FOR SUBJECTS THAT ARE RANDOMIZED, ONE OR THE OTHER. >> SO I THINK IN THE NEW CATEGORIES, I THINK THAT'S THE JUSTIFICATION FOR THE OVER THE COUNTER QUALIFIER. SO I THINK THOSE CHEMOTHERAPY AGENTS WOULDN'T FALL UNDER A. MAYBE IF WE ADD THE PAREN THEY WILL THET CAL BACK WE WANT TO TALK ABOUT THE RISKS OF THE STUDY AS WELL AS THE RISK OF THE DRUGS, SORT OF THAT DIFFERENCE. THE OTHER THING IS MAYBE UNDER B, CLASS 1 DEVICES THAT KEEP MAINTAINING SOME PARALLELISM, IS THAT THE EQUIVALENT OF OVER THE COUNTER DRUGS? >> I DON'T KNOW HOW OFTEN YOU'D BE DOING CLINICAL RESEARCH ON A CLASS 1 PROJECT. YOU COULD SAY YEAH, IF YOU'RE COMPARING TWO TONGUE DEPRESSORS, BUT THAT MIGHT BE MORE OF A NULL SET. >> SO WHAT I'VE GOT FOR NOTES IS TO CONSIDER PUTTING BACK IN THAT PARENTHETICAL LIMITATION, AND THAT MAY BE VERY APPROPRIATE IN& TERMS OF NOT ACCIDENTALLY OVEREXPANDING THESE CATEGORIES. INITIALLY FOR A AND B, THE SUBCOMMITTEES JUST TRIED TO SIMPLIFY AND SHORTEN THE LANGUAGE TO BOIL IT DOWN TO WHAT IT WAS SAYING IN ESSENCE ABOUT WHAT WOULD BE APPROVABLE, BUT MAYBE WE'VE STRIPPED OUT A LITTLE BIT TOO MUCH, SO I CAN PUT THAT BACK IN AND SEE IF IT'S APPROPRIATE. I JUST DON'T HAVE IT COMMITTED TO MEMORY SO I CAN'T TYPE IT IN ON THE FLY. >> SO JUST ANOTHER THOUGHT. IT IS SUPPOSED TO BE MINIMAL RISK, THAT DETERMINATION IS SUPPOSED TO BE MADE EVEN THOUGH THIS IS THE PRESUMPTION. IS IT INAPPROPRIATE TO REMIND PEOPLE OF THAT IN THIS CATEGORY IN PARTICULAR? BECAUSE THESE ARE DRUG AND DEVICE STUDIES. IT'S NOT NECESSARY LOGICALLY BECAUSE THESE ARE PRESUMED TO BE BUT YOU STILL HAVE TO MAKE THAT DETERMINATION, BUT WE'RE WORRIED ABOUT THAT, THAT'S WHY WE'VE CHANGED THESE, OTHERWISE WE COULD HAVE LEFT THEM THE SAME. >> YEAH. I THINK WHAT I WOULD PROPOSE IS THAT I TAKE THE PARENTHETICAL, PUT IT BACK IN, AND IF IT'S SORT OF A STRANGE FIT, THEN CHANGE IT TO SOMETHING ABOUT A MINIMAL RISK ADMONITION. I'M A LITTLE HESITANT BECAUSE IF YOU DO IT FOR ONE CATEGORY, WHY WOULDN'T YOU DO IT FOR ALL OF THEM? I THINK IN THE FIRST PAGE OF THIS DOCUMENT, WE'VE TAKEN QUITE A BIT OF PAIN TO HAMMER HOME THE WHOLE IDEA THAT IT HAS TO BE MINIMAL RISK, BUT I'M HAPPY TO WORK ON THAT AND SEE IF I CAN COME UP WITH SOMETHING THAT FITS FOR THIS CATEGORY ONE AND MAKES IT CLEAR THAT THERE ARE STILL IN FACT SOME LIMITATIONS THAT THE IRBs HAVE TO CONSIDER. >> I DON'T KNOW IF THERE'S A WAY TO PHRASE THIS SO THAT THIS IS AN OPTION THAT IRBs HAVE BUT NOT A MANDATE? I'M THINKING IF OUR IRB WOULD NOT APPROVE OVER THE COUNTER DRUG STUDIES AS MINIMAL RISK, WE WOULD SAY THEY'RE GREATER THAN MINIMAL RISK, AND I WOULD HATE TO PUT PEOPLE IN THE POSITION THAT THEY'RE NOW GOING TO BE TENSIONED WITH THEIR INVESTIGATORS WHO ARE GOING TO INSIST THE STUDY SHOULD BE ABLE TO DID FORWARD AND GO FORWARD AS EXPEDITED WHEN AN IRB MIGHT WANT TO TAKE IT TO FULL BOARD. >> THAT'S A GREAT POINT AND I'M HOPEFUL IF WE CAN REVISE NUMBER 1 A LITTLE BIT TO MAKE IT CLEAR THAT IT HAS TO BE ALMOST OBVIOUSLY MINIMAL RISK, THAT THAT TAKES SOME OF THAT CONCERN I ALSO THINK THE NEW RULE IS PROVOCATIVE FOR ANYTHING THE IRB WANTS TO ESCALATE TO THE FULL BOARD BECAUSE THAT'S THEIR COMFORT LEVEL. I THINK THERE ARE A NUMBER OF THINGS IN HERE WHERE AT LEAST ANECDOTALLY IRBs HAVE A HABIT OF WORRYING ABOUT CERTAIN KINDS OF RESEARCH AND BUMPING IT UP, AND THAT, I DON'T KNOW THAT WE'LL -- THE REGULATIONS HAVE TRIED TO PUT IN A MECHANISM TO FIX THAT. I DON'T KNOW THAT MASSAGING THE LIST IS GOING TO ACCOMPLISH THAT TOO MUCH. BUT HAPPY TO TRY TO FIGURE OUT HOW TO MAKE ONE READ BETTER AND BE MORE READILY UNDERSTOOD BY THE REGULATED COMMUNITY. >> WILL YOU BE CRAFTING SOME EXAMPLES THAT MIGHT BE HELPFUL? ALL THE REST OF THEM HAVE EXAMPLES. THIS ONE DOESN'T. >> THE REST OF THEM DO HAVE EXAMPLES. I DON'T KNOW IF I COULD DO THAT OVERNIGHT, BUT -- WE HAD TROUBLE COMING UP WITH EXAMPLES OURSELVES. I DON'T KNOW HOW OFTEN THESE CATEGORIES ARE PUT INTO USE. SO THERE MAY BE JUST A BROADER QUESTION ABOUT THEIR UTILITY OVERALL, BUT WE DIDN'T HAVE DATA TO INFORM US ABOUT HOW OFTEN THEY'RE BEING USED. THERE ARE CATEGORIES THAT DON'T HAVE EXAMPLES IN THE CURRENT LIST, BUT WE STRUGGLED TO COME UP WITH ACTUAL GOOD EXAMPLES FOR THESE. >> CAN I ASK, TO HELP DAVID OUT, IF YOU HAVE EXAMPLES IN YOUR IRB EXPERIENCE WHERE THIS HAS HAPPENED, IF YOU COULD SORT OF SUITABLY ANONYMIZE THEM AND SEND THEM TO HIM, BECAUSE I THINK REAL CASE STUDIES ARE OFTEN MORE INFORMATIVE ANYWAY. >> I'LL WORK ON MODIFYING ONE FOR THE MINIMAL RISK ASPECT AND TRY TO SOLICIT EXAMPLES FROM THE SUBCOMMITTEE, AND OF COURSE IF OR TWO, THAT MAYBE HELPS PROVIDE INCORPORATE THAT. I'M GOING TO STEP ON TO NUMBER 2 BECAUSE T HIS IS ANOTHER ONE WHERE THIS CATEGORY HAS MOREMORPHED SEVERAL TIMES. AS YOU CURRENTLY SEE, WE'VE REFRAINED FROM PUTTING BACK IN THE WORDING THAT IT HAS TO BE HEALTHY ADULT, SO WE NOW SAY, FROM ADULTS WHOSE HEALTH WILL NOT BE ADVERSELY AFFECTED BY THE BLOOD DRAWS, WHO WEIGH AT LEAST 50 KILOGRAMS, THE AMOUNTS COLLECTED SHOULD NOT EXCEED, AND THERE'S ROUGHLY THE OLD AMOUNTS. OR B, FROM CHILDREN AND OTHER ADULTS, THE AMOUNTS COLLECTED SHOULD NOT EXCEED THE LESSER OF THESE TWO VALUES. THE 150 IS NEW, AND AGAIN JUST BRIEFLY FOR THE NEWER MEMBERS, THE OLD LIST HAD A MUCH SMALLER LIMIT. WE TALKED AMONG THE SUBCOMMITTEES BOTH WHEN WE FIRST LOOKED AT THE EXPEDITED REVIEW LIST FIVE YEARS AGO AND THEN IN THIS GO-ROUND THAT THAT LIMITATION SEEMS SMALL WHEN YOU CONSIDER THAT CHILDREN AND ADILTS -- CHILDREN IN PARTICULAR, YOU MAY HAVE A 17-YEAR-OLD 200-POUND YOUNG MAN WHO IS PHYSICALLY CLOSER TO AN ADULT THAN A CHILD BUT HAD THESE VERY SMALL LIMITATIONS. WE WERE ASKED TO PROVIDE SOME SORT OF -- SOMETHING SPECIFIC TO SUPPORT THE IDEA THAT THIS WAS MINIMAL RISK BUT SO FAR WE HAVE FAILED TO PROVIDE ANYTHING. SO I STILL DON'T HAVE ANY SORT AFTER FOOTNOTE SAYING WHICH 150-MILLILITERS -- THE LESSER OF THOSE TWO AMOUNTS MAY BE MINIMAL RISK, SO WELCOME -- CONTINUE TO WELCOME FEEDBACK ON THAT, AND THEN UNDER THE EXAMPLES, THIS IS MORE OR LESS THE SAME EXAMPLE LIST WE LOOKED AT LAST TIME WHERE WE DID EXPAND IT FROM THE CURRENT LIST JUST TO HAVE OTHER ALLOWABLE PROCEDURES FOR OBTAINING THESE SPECIMENS. >> SO I'VE BEEN AWARE, I GUESS, FOREVER OF THE 50-KILOGRAM THRESHOLD, BUT NOW FOR THE FIRST TIME I'M QUESTIONING IT. SUNS PEOPLE IN THIS ROOM MAYSINCE PEOPLE I N THIS ROOM MAY BE EXCLUDED FROM EXPEDITED RESEARCH. MY WIFE CERTAINLY WOULD BE. WHAT'S THE BASIS OF THAT? >> YOU KNOW, THAT IS FROM THE OLD LIST AND MICHELE, DO YOU REMEMBER? MICHELE HELPED WRITE THE OLD LIST. SO ANYTHING YOU HATE ABOUT THE OLD LIST -- >> MY RECOLLECTION IS WE SOUGHT INPUT FROM THE RED CROSS AND OTHER PLACES ABOUT WHAT THEY CONSIDERED TO BE STANDARD AMOUNTS FOR BLOOD DRAWS AND APPROPRIATE AMOUNTS, AND THAT WAS HOW THOSE NUMBERS WERE ARRIVED AT. BUT THIS WAS A LONG TIME AGO. TAKING 5 ML FROM SOMEONE WHO WEIGHS 100 POUNDS. >> WELL, THEY WOULD FALL INTO CATEGORY B, SO YOU WOULD HAVE TO -- SO CATEGORY B IS CHILDREN AND OTHER ADULTS, SO IF YOU HAD A 49-KILOGRAM ADULT, YOU COULDN'T TAKE OUT A FULL 550 BUT YOU COULD CERTAINLY TAKE OUT, DEPENDING ON THEIR WEIGHT, UNTO 150. THIS IS ONE OF THE AREAS I WOULD SAY THE SUBCOMMITTEE WOULD LOVE TO LEAVE IN THAT NEW AMOUNT FOR CHILDREN AND I WOULD JUST SAY THAT OBVIOUSLY THIS IS NOT THE END OF THE DISCUSSION ABOUT THIS EVEN IF SACHRP WERE TO APPROVE THIS LIST. I DON'T KNOW -- I CAN'T SPEAK TO WHAT THE REGULATORS WILL DO IN TERMS OF SOLICITING COMMENTS OR VETTING PROPOSED CHANGES AS TO WHETHER IT'S MEDICALLY ACCEPTABLE OR STILL MINIMAL RISK. I'M NOT WEDDED TO IT, BUT -- >> THANKS, DAVID. JUST A COMMENT, I THINK I'VE NOTED THIS BEFORE IN TERMS OF JUST THINKING OUT LOUD ABOUT HOW THIS WOULD ACTUALLY BE ADMINISTERED. THE PRIOR VERSION WE JUST TALKED ABOUT HEALTHY PEOPLE IN GENERAL, IT WAS MORE STRAIGHTFORWARD. FOR YEARS, I WAS THE MAIN REVIEWER ON A PARTICULAR IRB, AND YOU KIND OF -- ALL YOU HAD TO KNOW WAS HERE ARE THE AMOUNTS AND THEY WERE ENROLLING HEALTHY SUBJECTS. NOW, UNLESS SOMEBODY IS GOING TO COME ALONG AND SAY NO MATTER HOW UP HEALTHY SOMEONE IS, THE AMOUNTS LISTED IN A IS VIRTUALLY NEVER GOING TO BE TROUBLESOME TO THEM, BUT IF THAT IS NOT THE CASE AND IT NOT OBVIOUS THAT SOME PRESTIGIOUS GROUP IS GOING TO COME ALONG AND SAY THAT, YOU KIND OF -- IF ONE OF US HAS AN EXPEDITED REVIEWER ENCOUNTERED SOME STUDY INVOLVING SOME PEOPLE WITH A PARTICULAR MEDICAL CONDITION AND YOU'RE TRYING TO IMPLEMENT 2A, IT'S LIKE WHAT ACTUALLY HAS TO HAPPEN FOR THE REVIEWER TO FIGURE OUT THE PERSON WON'T BE ADVERSELY AFFECTED BY THIS AGAIN, THE INTENT OF THESE RULES WAS TO MAKE IT FAIRLY BLACK AND WHITE, THAT THERE'S A UNIFORM IMPLEMENTATION OF THESE RULES. SO I'M JUST POINTING THAT OUT, THAT THERE'S BEEN A MAJOR ELEMENT INTRODUCED ABOUT WHAT DO YOU ACTUALLY WANT THE REVIEWER TO DO THE MOMENT YOU'RE DEALING WITH A STUDY WITH SOMEBODY WHO IS NOT HEALTHY, AND NOW THESE AMOUNTS ARE BEING APPLIED. >> I KNOW ONE PROBLEM THAT REVIEWERS ALSO HAVE IS WHEN YOU GO TO -- INCLUDING PEOPLE WHO MY IT MIGHT NOT BE HEALTHY GETTING BLOOD DRAWN FOR CLINICAL PRACTICE, HOW DO YOU FACTOR THAT IN. SO YOU HAVE A SUBJECTS IN THE ICU AND IS ALREADY GETTING 20 TO 30 CCs OF BLOOD DRAWN A TAI FOR A DAY FOR CLINICAL PURPOSES, HOW DO YOU INCLUDE THAT IN WORKING WITH THIS SORT OF RESTRICTION. AND WE MAY NOT BE ABLE TO CRAFT SPECIFIC LANGUAGE FOR THAT, BUT TO MAKE IRBs AWARE THAT THEY NEED TO INCORPORATE THAT WHEN CONSIDERING THIS FOR EXPEDITED RESEARCH. BECAUSE THE PUSH IS OFTEN, WELL, THEY'RE ALREADY HAVING THEIR BLOOD DRAWN, WE ALREADY HAVE AN INGEL INDWELLING CATHETER, THERE'S NO ADDITIONAL RISK, THERE'S NO NEEDLE STICK. >> I THINK THAT'S A FAIR COMMENT. EARLY ON I KNOW WE WRESTLED WITH THIS IDEA OF TRYING TO FIGURE OUT HOW TO MAKE PEOPLE THINK ABOUT THE CLINICAL SETTING AND WHAT MIGHT BE GOING ON OUTSIDE THE RESEARCH CONTEXT AND, FRANKLY, WE COULDN'T COME UP WITH A SOLUTION THAT WE COULD AGREE ON. SO IN THAT CASE, WE STUCK CLOSER TO THE ORIGINAL LANGUAGE. >> JUST AS A POINT OF INFORMATION, IN THIS CATEGORY, CAN YOU PLACE A PERIPHERAL VENOUS CATHETER FOR RESEARCH PURPOSES UNDER EXPEDITED REVIEW? I JUST WASN'T CLEAR WHEN I READ THIS WHETHER YOU COULD ONLY TAKE BLOOD FROM AN ALREADY PLACED INDWELLING CATHETER FOR CLINICAL PURPOSES OR WHETHER YOU WERE ABLE TO PLACE ONE FOR RESEARCH PURPOSES. >> SO THE LAST TWO LINES OR SO OF THAT, WE TRIED TO DIFFERENTIATE BETWEEN AN INDWELLING CATHETER THERE FOR CLINICAL PURPOSES AND SAYING THAT HAD TO ALREADY BE THERE IF YOU WERE GOING TO EXPEDITE THE DRAW. BEFORE THE COMMA, IT WOULD HAVE TO BE THE PERIPHERAL CATHETER, WE THOUGHT WOULD BE FIEP TO EXPEDITE IF IT WAS BEING PLACED FOR RESEARCH PURPOSES. >> SO DAVID I'LL TAKE A MOMENT TO MAKE A GENERAL OBSERVATION WHICH I THINK MAKES THIS TASK THAT YOU'VE UNDERTAKEN DIFFICULT. WE HAVE TWO SEPARATE THINGS WE'RE DOING HERE. ONE IS ADAPTING THE EXPEDITED REVIEW LIST TO THE CHANGES IN THE FINAL RULE, AND THAT IS TO ADD THE PRESUMPTION THAT IT'S MINIMAL RISK. AND THE SECOND IS TO UPDATE THE EXPEDITED REVIEW LIST. AND I AM MUCH MORE COMFORTABLE WITH THINGS DONE TO ADDRESS THE FIRST ONE THAN RECOGNIZING US AS THE GROUP TO ADD OR TAKE THINGS OFF THE EXPEDITED REVIEW LIST. SO WE'LL SEE HOW THIS ALL -- I'VE SHARED THAT CONCERN BEFORE AND WE'LL JUST SEE HOW IT ALL WORKS OUT, BUT FROM MY POINT OF VIEW, OUR PRIMARY TASK, WE'RE WORKING OFF A BASE OF AN UPDATED LIST THAT WAS DONE IN 2012, 2013, SO THAT ADDS COMPLEXITY TO IT. BUT I THINK WHAT WE HAVE TO DO PARTICULARLY TODAY IS TO ADAPT IT TO THE NEW PRESUMPTION. >> I KNOW WE'VE TALKED ABOUT THIS A LOT IN THE SUBCOMMITTEES, BUILDING OFF OF WHAT JERRY SAID, I REMAIN MODERATELY UNCOMFORTABLE WITH THIS LANGUAGE œNOT BE ADVERSELY AFFECTED ASLL COMPARED TO HEALTHY ADULTS. I KNOW THE THOUGHT IS WHAT IF YOU HAVE A WELL CONTROLLED DIABETIC, WOULD AN IRB CONSIDER THEM NOT TO BE HEALTHY AND NOT BE ABLE TO BE EXPEDITED UNDER THAT LIST, BUT I CAN JUST IMAGINE ALL SORTS OF CIRCUMSTANCES WHERE AN INVESTIGATOR TRIES TO CONVINCE AN IRB REVIEWER THAT TAKING 100 CCs OF BLOOD FROM ACTUALLY A PERSON WHO'S SICK, THAT THEIR HEALTH WOULD NOT BE ADVERSELY AFFECTED, THAN FROM THEIR BASELINE STATE. SO AGAIN TAKING BLOOD OUT OF THE ICU PATIENT OR WHATEVER. SO IT JUST -- IT MAKES ME UNCOMFORTABLE, AND I UNDERSTAND WHY IT GOT THERE BUT I'M NOT SURE HOW TO FIX IT WITHOUT GOING BACK TO BEING PRETTY RESTRICTIVE RESTRICTIVE. >> IT CERTAINLY CHANGES THE CALIBER OF REVIEWER THAT IS REQUIRED TO MAKE THIS DECISION. BECAUSE IF YOU HAVE A HEALTHY ADULT STANDARD, THEN IT'S A QUESTION OF MATH. BUT IF YOU HAVE THIS KIND OF AMBIGUOUS STANDARD, THEN YOU HAVE TO MAKE A MEDICAL DECISION ABOUT WHETHER THIS EXPEDITED CATEGORY HOLDS, AND I THINK THAT'S JERRY'S POINT TOO, WHICH MAKES THAT -- MAKES THIS EXPERIENCED REVIEWER PROBLEM A LOT MORE COMPLEX FOR AN IRB. >> I DON'T KNOW IF THAT'S A REQUEST TO REVERT TO HEALTHY. IS THERE SORT OF CONSENSUS, YEAH, I SHOULD TYPE THAT IN OR -- >> I JUST QUESTION WHAT YOU DEFINE AS HEALTHY. >> THAT'S HOW THE SUBCOMMITTEE GOT HERE. >> IF YOU LOOK AT VIRTUALLY ANY ADULT TODAY, WHETHER IT'S ELECTRONIC HEALTH RECORD OR WHATEVER, THAT MAN OR WOMAN WILL HAVE SOME DIAGNOSIS LISTED. AND DOES THAT DISQUALIFY THEM? >> WHICH WE DID HAVE A LOT OF DISCUSSIONS ABOUT WHO IS THE HEALTHY ADULT. JONATHAN GAVE ONE EXAMPLE OF A SMOKER. A SMOKER WOULD BE ANOTHER EXAMPLE. STEVE, DO YOU WANT TO DO A STRAW PULL? I'M HAPPY TO CHANGE IT. >> IT'S THE SAME PROBLEM FROM ONE SIDE OR THE OTHER. YOU CAN SAY HEALTHY AND THERE'S A QUESTION ABOUT WHAT THAT MEANS, OR YOU COULD SAY -- I DON'T KNOW. IF THE PROTOCOL IS WRITTEN -- I MEAN, IN THEORY, AT LEAST, YOU SHOULD BE LOOKING AT THE INCLUSION CRITERIA UNDER EITHER CIRCUMSTANCE AND THAT GETS TO THE QUALITY OF THE DECISION BEING MADE. I'M NOT SURE -- IT'S SORT OF A -- IT'S A WAY OF LOOKING AT IT. THAT BEING SAID, WE MAY AS WELL TAKE A STRAW VOTE. SO ALL OF THOSE WHO WOULD RETURN IT TO HEALTHY ADULT, FROM THIS LANGUAGE WHICH IS ADULTS WHOSE HEALTH WILL NOT BE ADVERSELY AFFECTED, PLEASE RAISE YOUR HAPPENED. ALL WHO PREFER THIS LANGUAGE? >> LEAVE IT? OKAY. DIANA. >> DO YOU MEAN CENTRAL VENOUS CATHETER THERE? BECAUSE THOSE ARE BOTH PERIPHERAL LINES. >> A STANDARD I.V. CATHETER IS ALLOWABLE, BUT A PIC, WHILE PERIPHERALLY INSERTED, TERMINATES CENTRALLY AND HAS A GREATER RISK PROFILE. SO YOU WOULDN'T WANT TO PLACE A PIC FOR RESEARCH PURPOSES BUT YOU COULD PLACE A STANDARD PERIPHERAL I.V. THAT COULD BE EITHER BUT IT'S NOT BEING PLACED FOR RESEARCH PURPOSES. IT'S THERE FOR -- IT'S ALREADY THERE. IT'S AN EXISTING CATHETER SO THAT'S DRAWING OFF SOMEBODY'S CENTRAL LINE. >> SO NUMBER THREE, THIS ONE IS HAS ALSO GONE THROUGH A FEW DIFFERENT REVISIONS SO A LOT OF WHAT IS LEFT TO HEAR COMES FROM THE EXISTING LIST. WE TRIED TO BROADEN IT QUITE A BIT AND HAD REMOVED A LOT OF EXAMPLES, BUT UNDER OUR FRAMEWORK FOR THINKING ABOUT EXPEDITED IN THE NEW CONTEXT, WE DECIDED IT MADE SENSE TO LOAD BACK IN THE EXAMPLES, SO THIS IS PROSPECTIVE COLLECTION OF BIOLOGICAL SPECIMENS BY NONINVASIVE MEANS. IT'S LARGELY THE OLD LIST, AND I THINK PRETTY STRAIGHTFORWARD. >> I HAD ONE QUESTION ON THIS. THIS IS AN AREA I DON'T KNOW ANYTHING ABOUT, BUT E IT SEEMS VERY SPECIFIC. I DON'T KNOW WHAT OTHER WAY THERE IS ARE TO STIMULATE SALIVA SECRETION, BUT IT SEEMS LIKE TO ONLY ALLOW IT, IF IT'S DONE THAT WAY. AND THAT IS FROM -- THAT'S LITERALLY FROM THE OLD RULE. I JUST DON'T KNOW ITS BASIS. IT SEEMS LIKE THINGS MAY HAVE CHANGED SINCE THE OLD LIST WAS WRITTEN. MICHELE, ANY COMMENT? IT'S HARMLESS TO LEAVE IT BUT I DON'T KNOW IF WE'RE EX-CLEUTD CLEUDING SOMETHING THAT'S REALLY BENIGN. IF SOMEONE IS A SPECIALIST IN SALIVA SECRETION, SPEAK UP NOW. >> I WOULD BE HAPPY TO SHORTEN IT TO UNCAN EU UNCANNULATED SALIVA. IF SOMEBODY CAN THINK OF A DEVIOUS WAY TO COLLECT THAT SALIVA THAT'S MORE THAN MINIMAL RISK I'LL BE HAPPY TO PUT THIS BACK IN. >> I THINK IT'S PUTTING A CANNULA INTO THE SALIVARY GLAND. I DON'T THINK IT'S PLEASANT. >> NO, NO, CAN EU -- >> THEN IT WOULD BE NONINVASIVE. BUT I'LL GET RID OF ALL THAT AND PEOPLE CAN HAVE ALL THE SALIVA THEY WANT. OR NEED. >> I HAVE A QUESTION ABOUT A. >> YES. >> DOES THAT INCLUDE URINE, STOOL, HAIR AND NAIL? D? >> SO I THINK A DID USED TO SPECIFICALLY SAY HAIR AND FINGERNAILS. DIDN'T IT, MICHELE? >> I'M NOT SURE WHAT CATEGORY YOU PUT IT IN BUT I WOULD LIKE IT TO BE VERY CLEAR WHERE URINE, STOOL, HAIR AND NAILS FIT INTO THIS WHOLE THING. >> [INAUDIBLE] >> STILL VERY RELEVANT. LOTS OF DRUG STUDIES. IT JUST DOESN'T MENTION IT. WE'VE GOT REMARKABLE LEVEL OF DETAIL IN SOME AREAS AND WE LEAVE OUT STUFF THAT PEOPLE DO OFTEN AND IT'S NOT CLEAR THAT THEY'RE IN THERE OR WHERE EXACTLY THEY GO. SO WHICH ONE IS A URINE SAMPLE? >> D WOULD BE -- >> SO COULD WE SAY INCLUDING SWEAT, URINE, STOOL? LIKE WE HAVE DEWORMING STUDIES. >> DO PEOPLE FEEL WE SHOULD PUT HAIR AND NAILS IN A AS EXEMPLARS? THAT'S REALLY WHAT YOU ARE SUGGESTING. >> YEAH, I JUST -- [INAUDIBLE] >> OKAY. MOVING ON, SORRY, 4 SPLITS OVER A PAGE BREAK. SO 4, PROSPECTIVE COLLECTION OF BIOLOGICAL SPECIMENS EXCLUDING BLOOD NOR RESEARCH PURPOSES BY MINIMALLY INVASIVE MEANS NOT REQUIRING SEDATION FOR RESEARCH PURPOSES. PROVIDING THAT -- AND THEN THERE'S SOME PARAMETERS AROUND THAT AND YOU'LL SEE THE FOOTNOTE NUMBER 3, THAT FOOTNOTE NUMBER 3 I'LL SCRO LL DOWN QUICKLY CITES FDA GUIDANCE ON IN VITRO DIAGNOSTIC MEDICAL STUDIES WHERE THEY HAVE Q & A THAT DESCRIBES WHAT THEY CONSIDER NONINVASIVE AND THIS IS REALLY CUT AND PASTED FROM THAT. AND THEN WE HAVE EXAMPLES HERE, REID, WE HAVE PUT SOME PARAMETERS AROUND THE SKIP PUNCH AND WELCOME YOUR FEEDBACK IF THEY APPEAR APPROPRIATE. >> DAVID, I HAD A QUESTION AGAIN, THIS IS A LEARNING THING FOR ME. WHAT IS COLLECTION FROM -- THAT PENETRATES THE OCULAR CAVITY THAT'S NONINVASIVE? HOW DOES THAT PENETRATE THE OCULAR CAVITY? >> [INAUDIBLE] >> NO, NO, IT DOESN'T, RIGHT, BUT WE EXCLUDE -- MINIMAL RISK, N, IT NONINVASIVE AND DOES NOT PENETRATE THE OCULAR CAVITY, THAT SEEMS TO ME WE DON'T NEED THAT QUALIFYIER. I CAN'T THINK OF A NONINVASIVE WAY TO PENETRATE THE OCULAR CAVITY. SO IT'S ANOTHER ONE OF THESE SPECIFIC THINGS THAT I DON'T KNOW WHY IT'S THERE. >> I DON'T KNOW EITHER. WE'VE REALLY JUST STOLE THAT FROM THAT FDA GUIDANCE. WE DIDN'T THINK TOO DEEPLY BEYOND THAT IN THIS PARTICULAR CASE. >> JUST A QUESTION, DAVID. SO 4, YOU'RE SAYING THE FDA DOCUMENT TALKS ABOUT NONINVASIVE STUFF? >> CORRECT. >> BECAUSE THE CAT DPRI IS CATEGORY IS ABO UT MINIMALLY INVASIVE AND THAT'S NUT CONCEPT, RIGHT? THE NEW CONCEPT, RIGHT? SO WHAT CONSTITUTE MINIMALLY INVASIVE AND HOW DOES THE FDA DOCUMENT HELP? BECAUSE 3 WAS THE CATEGORY THAT DEALS WITH NONINVASIVE STUFF, RIGHT? >> SO YOU'RE CORRECT, AND WHERE WE GOT TRIPPED UP LAST TIME IS THAT 4 AND 3 USED TO BE COMBINED INTO ONE BIG CATEGORY, AND THERE WAS SOME CONCERN THAT THINGS THAT ARE IN THE EXAMPLES OF 4 CLEARLY WEREN'T NONINVASIVE, AND SO TO JUSTIFY SAYING THAT THESE WERE MINIMALLY INVASIVE PROCEDURES, THE CLOSEST SORT OF READY THING THAT WE COULD FIND WHERE SOMEBODY HAD TRIED TO PUT SOME PARAMETERS AROUND WHAT LEVEL OF INVASIVENESS WOULD BE MINIMAL RISK WAS IN THAT IVD GUIDANCE SO THEY USED NONINVASIVE, AND WE CO-OPED THEIR PARAMETERS BUT CHANGEED IT. THERE SEEMED TO BE A CONSENSUS LAST TIME THAT OBTAINING SAMPLES FROM THE URETHRA OR GOING INTO THE MOUTH BEYOND THE PHARYNX WAS NOT NONINVASIVE, AND WE THOUGHT IT WAS MINIMALLY INVASIVE. >> I THINK THEY'RE STILL A LITTLE CONFUSING. YOU TALK ABOUT NOT PENETRATING THE URETHRA AND THEN YOU TALK ABOUT EU URETHRAL SWAB. IT'S HARD TO KNOW WHAT'S MINIMALLY INVASIVE WHEN IT'S WORDED INVOLVING THE ANUS BUT NOT GOING PAST THE RECTUM, THAT'S A FAIRLY BROAD AREA TO CALL MINIMALLY INVASIVE, AND I THINK THAT THERE ARE MANY PLACES THAT WOULD BE UNCOMFORTABLE JUST EXPEDITING RESEARCH WITH THAT KIND OF INVASIVENESS OF THE STUDY. >> JONATHAN? >> THE KIND OF THING I WOULD THINK OF, SO THERE'S PRETTY STANDARD PRACTICE OF SWABBING, NASAL SWAB AND RECTAL SWABS TO SCREEN FOR MRSA OR OTHER -- AND THOSE HAVE ALWAYS BEEN ABLE TO BE CONSIDERED MINIMAL RISK AND EXPEDITED IF IT'S JUST A SURVEILLANCE, AND I THINK THIS IS TRYING TO MAKE SURE WE DON'T SUDDENLY -- TO CAPTURE THOSE KINDS OF PROCEDURES. >> AND I THINK YOU NEED TO CHANGE THE WORDING TO "ANAL CANAL." >> IT SAYS THAT. >> WHEN I READ THAT, I WAS -- >> JUST STOP AT CANAL? >> YEAH. >> OH, OKAY. >> I THINK ONE THING WE COULD -- ONE WAY THAT WE COULD THINK ABOUT CHANGING CATEGORY 4 WOULD BE TO COME UP WITH SOMETHING THAT'S CLOSER TO THE KINDS OF PROCEDURES THAT JONATHAN DESCRIBED, THAT ARE DEBATABLE AS TO WHETHER OR NOT THEY'RE TECHNICALLY NONINVASIVE. WE STILL WOULDN'T HAVE A DEFINITION OF MINIMALLY INVASIVE BUT WE COULD HAVE A FAIRLY -- WE COULD COME UP WITH A FAIRLY LENGTHY LIST OF TYPES OF EXAMPLE EXAMPLES. WHEREAS BEFORE, WE WERE A LITTLE HESITANT TO LIST LOTS OF EXAMPLE, IT'S BECOME CLEAR THAT LOTS OF EXAMPLES IS A GOOD THING FOR THE PURPOSES OF THIS LIST, SO WE COULD LOSE A LOT OF THE FIRST FEW LINES OF THAT IF IT WAS CAUSING MORE CONFUSION, WE COULD SIMPLIFY THAT STEM AND THEN JUST HAVE A LONGER LIST OF EXAMPLES. I'D STILL BE IN A PLACE OF HAVING NO FIRM DEFINITION OF MINIMALLY INVASIVE. I COULD STILL REFER TO THE FDA GUIDANCE AND LET THE EXAMPLES SORT OF HELP SET THE BOUNDARIES. >> SO DAVID, JUST TO BE CLEAR, BECAUSE I'M NOT SURE I GET THIS, WE PRODUCED 4, WHICH IS A NEW CATEGORY FORMIN MEDICALLY INVASIVE ON TOM OF THE 3 WHICH IS NONINVASIVE, BUT TO DEFINE WHAT'S MINIMALLY INVASIVE, WE USE THE FDA DEFINITION OF NONINVASIVE. >> YES. >> SO JUST AN ALTERNATIVE WOULD BE TO USE THAT DEFINITION AND PUT IT ALL BACK UNDER 3. >> YES, THAT WOULD BE AN OPTION AS WELL. AND I'M REALLY HAPPY TO DO WHAT THE COMMITTEE LIKES. I THINK WE DID THINK IT MADE SENSE TO SEPARATE THEM OUT JUST BECAUSE 3 COULD REALLY BECOME QUITE LENGTHY AND GET OUT OF HAND SO TO SPEAK. THIS SEEMED LIKE A NICE LINE TO DIVIDE THOSE TWO TYPES OF SPECIMEN COLLECTION ACTIVITIES, THE ONES THERE SEEMED TO BE CONSENSUS WERE NOT INVASIVE VERSUS THE ONES THAT WERE EITHER MINIMALLY INVASIVE OR WHATEVER TERM WE LIKE, BUT THEY CLEARLY WENT BEYOND JUST -- >> IT HELPS WITH ASSIGNING REVIEWER, BECAUSE SOMEONE CAN& MAKE A JUDGMENT ABOUT CATEGORY 3 MORE EASI LY THAN THEY CAN CATEGORY 4, AND I THINK THAT'S HELPFUL. AND I ALSO WONDER WHAT IS CURETTAGE UNDER CATEGORY 4? >> THAT'S THE WORD THAT GAVE ME PAUSE AS WELL. I HAVEN'T BEEN INVOLVED IN SURGICAL PROCEDURES SINCE MEDICAL SCHOOL, BUT I DO RECALL, AND I'LL DEFER TO DR. KATZ, THAT THERE ARE SOME CURETTAGE PROCEDURES THAT ARE NOT MINIMALLY INVASIVE. >> I INTERPRETED THAT AND THAT WAS MY QUESTION TOO, IS I INTERPRET THAT AS A SWAB GOING INTO THE URETHRA, WOULD BE HOW I THINK MOST PHYSICIANS WOULD INTERPRET THAT, AND THAT IS NOT IN MY MIND MINIMALLY INVASIVE. >> CURETTAGE JUST MEANS A SCRAPING. SO IT COULD BE USED ANYWHERE. >> BUT YOU WOULD NEED TO HAVE A SWAB INSIDE THE URETHRA. >> AND IF THAT PARTICULAR WORD IS CAUSING CONSTERNATION, I THINK IT'S CERTAINLY FINE TO DROP THAT. THE IMPLICATIONS ARE ONLY THAT STUDIES THAT HAD THAT SPECIFIC PROCEDURE WOULD GO TO A FULL BOARD. AND BY ELIMINATING THAT, HONESTLY OTHER THAN SKIN PUNCHED BIOPSIES ARE ONE THING BY UNDER B, WE GET A LOT CLOSER TO THE THINGS JONATHAN WAS TALKING ABOUT, SOUTHWEST MENS COLLECTED BY SWABS. I DON'T KNOW IF WE STILL NEED ALL OF THIS WITH THESE EXAMPLES. >> THIS MAY ALREADY BE THE DIRECTION YOU'RE GOING IN, SINCE IT SEEMS A BIT UNCLEAR WHAT MINIMALLY INVASIVE IS, THIS GETS BACK TO DEBATES WE'VE HAD ABOUT EXAMPLES VERSUS YOU COULD JUST LIST, HERE ARE TWO THINGS COVERED UNDER THIS CATEGORY, SO PEOPLE DON'T HAVE TO BE GUESSING WHAT THE OTHER THINGS ARE THAT MIGHT MEET THE DEFINITION OF MINIMALLY INVASIVE. THAT'S ALWAYS THE PROBLEM WITH THE EXAMPLES. PEOPLE RAISE THE ISSUE EARLIER ON, WHERE THE PRIOR LANGUAGE TOLD YOU HOW YOU COLLECTED BLOOD AND BEFORE IT WAS FAIRLY CLEAR BECAUSE IT ACTUALLY SAID YOU WERE ONLY ALLOWED TO COLLECT BLOOD BY THE FOLLOWING SEVEN METHODS. NOW YOUR NEW VERSION GAVE EXAMPLES BUT NEVER THEN EXPLAIN WHAT ACTUALLY IS THE STANDARD BY WHAT YOU FIGURED OUT WHAT A PARTICULAR BLOOD COLLECTION TECHNIQUE WAS OR WAS NOT ALLOWABLE. SO IN THIS SCENARIO, ONE OPTION COULD BE IF YOU SORT OF COVERED WHAT YOU THINK IS ALLOWABLE, YOU JUST SAY THE FOLLOWING ITEMS AS OPPOSED TO TRYING TO PROVIDE A BROADER DESCRIPTION, WHICH THEN LEADS PEOPLE TO FIGURE OUT WHAT EXACTLY IS MINIMALLY INVASIVE. >> I AGREA AND AGREE AND I THINK THAT IS WHERE WE'RE HEADED TO BACK OUT THE -- ALL OF THAT AND GETTING RIZ OF RID OF THAT PHRASE, MINIMALLY INVASIVE, AND FIX THE FRONT END TO GET RID OF THIS NEW TERM THAT WE'RE INTRODUCING. AND REPLACE IT WITH SOMETHING THAT MAKES SENSE GIVEN THE KINDS OF EXAMPLES WE'VE LISTED. IF I RETAINED THAT DELETION, DOES IT REMAIN PROBLEMATIC TO CONTINUE SAYING MINIMALLY INVASIVE? OR IS IT THAT USE OF THE FDA WORDS THAT HAS ACTUALLY CONFUSED IT? >> I ACTUALLY LIKE MINIMALLY INVASIVE. YOU HAVE TO HAVE SOMETHING THAT SETS IS OFF FROM 3. IT'S A STEP MORE POTENTIALLY INVASIVE THAN 3. AND AS LONG AS I WAS BOTHERED BY THE FACT THAT YOU'RE USING CRITERIA FOR WHAT'S NONINVASIVE TO DEFINE MINIMALLY INVASIVE. ONCE YOU TAKE THAT AWAY, I THINK ANYTHING YOU COME UP TO QUALIFY INVASIVE IS GOING TO HAVE THE SAME ISSUE, SO I THOUGHT MINIMALLY WAS -- >> OKAY. SO BARRING ANY BIG OBJECTIONS, THAT'S WHAT I PROPOSE THEN, IS DELETING THAT LANGUAGE FROM THE FDA GUIDANCE, RETAINING THE FACT THAT IT'S COLLECTED BY MINIMALLY INVASIVE MEANS NOT REQUIRING SEDATION, AND KEEPING THESE EXAMPLES IS MODIFIED SO IT'S THE SKIN PUNCH BIOPSIES WITHIN SPECIFIC LIMITS AND SPECIMENS COLLECTED BY SWABS. IF ANYBODY HAS ANOTHER GOOD EXAMPLE OF SOMETHING THEY THINK MAY HAVE BEEN LOST, I'M HAPPY TO ADD, THE MORE EXAMPLES THE BETTER, AS FAR AS I'M CONCERNED. JONATHAN? >> I'M JUST THINKING IF WE'RE GOING TO MAKE IT VERY DIRECTIVE, YOU WOULD WANT TO EXPAND THE NUMBER OF SWABS, BECAUSE NASAL SWABS IS OUT SO YOU'D WANT TO PUT THAT IN, SWAB OF THE EXTERNAL AUDITORY COULDAL IS PROBABLY WITHIN THE SAME RANGE. WE CAN TALK LATER. JUST WANT TO CAPTURE A FEW MORE. >> I'LL MOVE ON THEN. CATEGORY 5 IS COLLECTION OF ADDITIONAL INFORMATION OR SPECIMENS OTHER THAN BLOOD FOR RESEARCH PURPOSES DURING PROCEDURES ALREADY BEING PERFORMED FOR CLINICAL PURPOSES, PROVIDED ADDITIONAL COLLECTION DOES NOT PRODUCE MORE THAN MIN CAL INCREASE OF RISK OR DISCOMFORT OVER THAT IMPOSED BY THE UNDERLYING PROCEDURE. I'LL TALK MORE ABOUT ANESTHESIA IN A SECOND, AND THEN WE HAVE SOME EXAMPLES. WE STRUGGLED IN THE PAST WITH SAYING WHAT WE THOUGHT WOULD BE ALLOWABLE EXTENSION OF SEDATION. ONE OF THE SUBCOMMITTEE MEMBERS HAD GUIDANCE DEVELOPED LOCALLY AT THEIR INSTITUTION THAT WE'VE ADOPTED SO I'LL ZIP DOWN TO FOOTNOTE 4 AND HERE IS THE PARAMETERS THAT WE'RE PROPOSING WOULD BE MINIMAL RISK. I WOULD SAY NONE OF THE SUBCOMMITTEE MEMBERS ARE ANESTHESIOLOGISTS. SO WITH THAT, FOR THOSE THAT ARE MORE KA VEE ABOUT SAVVY ABOUT THIS THAN I AM, THAT'S FINE BUT WE HAD TO HAVE SOMETHING WE COULD PUT OUT THERE ABOUT WHAT MIGHT MAKES THE EXTENSION OF ANESTHESIA MINIMAL RISK. >> THIS EXTENSION OF ANESTHESIA IS ONLY APPLYING TO ADULTS? >> NO, NOT AS WRITTEN. >> SO THE LENGTH OF ANESTHETIC FOR INFANTS AND TODDLERS IS NOW A VERY SENSITIVE SUBJECT REGARDING THE NEW WARNINGS REGARDING POTENTIAL EFFECTS ON NEURODEVELOPMENT. I'M NOT SURE YOU WANT TO INCLUDE THAT POPULATION IN THIS SORT OF EXPEDITED REVIEW, IT'S GOING TO BE EXTENSION OF ANESTHESIA OF ANY SORT. >> OKAY. WE COULD CERTAINLY ADD THAT. WE COULD CERTAINLY LIMIT CATEGORY 5 TO ADULTS IF THAT WAS THE CONSENSUS. >> IS EVERYONE COMFORTABLE WITH EXTENSION OF ANESTHESIA BEING MINIMAL RISK UNDER THESE CIRCUMSTANCES? SO I'LL ONLY COMMENT THAT THAT'S A LONG LIST OF CRITERIA TO BE MET TO SATISFY MINIMAL RISK EXTENSION OF ANESTHESIA, WHICH MAY BE CHALLENGING IN SOME REVIEW SITUATIONS. IF THE PROTOCOLS ARE NOT EXPLICITLY WRIT TONE ADDRESS ALL OF THOSE POINTS. >> I CERTAINLY AGREE THERE ARE INSTITUTIONS THAT WOULD WANT TO HAVE S.O.P.s IN PLACE OR SOMETHING THAT HELPS THEM WORK THROUGH THE REQUIREMENTS FOR THAT AND MAKE SURE THAT THEY'RE CONFIRMING THAT THE DATA COLLECTION WOULD BE DONE UNDER THOSE CIRCUMSTANCES. IT'S NOT INSURMOUNTABLE BUT IT WOULD BE SOME WORK. I SAW ANOTHER HAND. >> SO ALL OF THE OTHER STUFF IS SOMETHING THAT SEEMS VERY SEPARABLE FROM ANYTHING ELSE THAT'S GOING ON, BECAUSE IT'S HAPPENING FOR RESEARCH PURPOSES AND IT'S CLEARLY DIFFERENT. AND THIS IS REALLY SOMETHING THAT'S HAPPENING IN THE CONTEXT OF ONGOING MEDICAL PROCEDURES AND CARE, WHICH MAKES ME WONDER WHO'S PAYING FOR IT. BECAUSE THE SURGICAL TIME IS LON E THE LONGER, THE ANESTHESIA IS GREATER, AND IT'S LINKED, IT'S KNITTED VERY TIGHTLY INTO THESE ONGOING PROCEDURES. SO THIS DOES COME UP IN CLINICAL TRIALS FROM TIME TO TIME IN VARIOUS WAYS IN WHO'S PAYING FOR THE EXTRA MONITORING THAT HAPPENS AS PART OF THE CLINICAL TRIAL, AND SOMETIMES IT'S THE INSURER THAT'S PAYING FOR IT. SOMETIMES IT'S THE PATIENT THAT'S PAYING FOR IT. BUT THIS IS REALLY SO TIGHTLY LINKED THAT COULDN'T THE PATIENT BE PRIMARILY AT RISK FOR COST HERE? AND HOW DOES THAT FIT IN? >> I THINK THAT'S AN INTERESTING QUESTION. IT'S NOT SOMETHING WE CONSIDERED CONSIDERED. I KOPT KNOW THAT IT WOULD BE IN THE NARROW CONTEXT OF THE EXPEDITED LIST -- IT'S JUST SOMETHING WE DIDN'T CONSIDER OR TALK ABOUT. THIS WAS ONE OF THE EXAMPLES OF THINGS WHERE THE SUBCOMMITTEES FELT AS FAR AS THE PROCEDURES GO, THAT WE WANTED TO CRAFT A MINIMAL RISK CATEGORY THAT WOULD FIT THIS. RESEARCH, THERE'S LOTS OF NON-EXPEDITED RESEARCH THAT HAPPENS IN THE CONTEXT OF CLINICAL CARE AND INVOLVES THESE THINGS. I WOULD SUGGEST THAT THAT MIGHT BE A QUESTION FOR THE IRB TO ASK DEPENDING ON THE CIRCUMSTANCE, BUT I DON'T THINK IT'S SOMETHING THAT EXPEDITED CATEGORY WOULD RESOME OF.. >> I AGREE WITH DAVID, I THINK THAT'S AN ISSUE THAT IRBs SHOULD CONSIDER BUT I DON'T THINK IT AFFECTS WHETHER OR NOT THESE PROCEDURES SHOULD BE EXPEDITABLE. AND THESE ARE VERY COMMON RESEARCH PROCEDURES. >> I THINK FOR SOMETHING THAT'S GOING TO EXTEND ANESTHESIA 10 TO 15 MINUTES, MOST IRBs WOULD NOT QUESTION WHERE THE FINANCIAL RISK IS, BUT THERE ARE CERTAINLY APPROVED STUDYS THAT THERE IS A SIGNIFICANT DIFFERENCE IN WHAT'S LIKELY TO BE THE BILLING, AND EACH IRB IS GOING TO HANDLE THAT INDIVIDUALLY FREQUENTLY, THERE'S INSTITUTIONAL SHIFT OF FONDZ AND WILL COME OUT OF DIVISIONAL OR DEPARTMENTAL FUNDS THAT WILL COVER THAT INCREASED COST OF CLINICAL/RESEARCH CARE, BUT AGAIN, TO PUT THIS IN THE REGULATIONS IS BEYOND WHAT WE SHOULD EXPECT THEM TO COVER, I THINK. >> PERHAPS IT MIGHT BE USEFUL TO MENTION THIS ISSUE IN DESCRIBING RISK. IT MIGHT BE USEFUL TO RAISE THAT AS PART OF IT TO JUST CALL ATTENTION TO THAT QUESTION. >> SO I'M GOING TO ASK THAT WE MOVE ON AND THINK ABOUT THAT AND WE COME BACK TO T BECAUSE I THINK IT'S A QUESTION OF MUCH GREATER IMPLICATION THAN THESE CHANGES TO THE EXPEDITE REVIEW LIST. IT'S SORT OF IN THE BACKGROUND FOR ALL I RSM Bs FOR EVERYTHING AND HOW TO BEST ADDRESS IT. WE CAN COME BACK AND TOUCH ON THAT AGAIN BUT LET'S KEEP MOVING THROUGH THE LIST. >> OKAY. SO I'VE GOT FOR CATEGORY 5 THEN, A CALL TO LIMIT IT TO ADULTS. AND I SEE A FEW HEADS NODDING SO I'LL MAKE THAT CHANGE. I JUST HAVE A NOTE TO DO THAT. >> THAT'S JUST FOR THE EXTENSION OF ANESTHESIA, NOT FOR THE REST? >> CORRECT. >> THANK YOU. CATEGORY 6 IS COLLECTION OF RESEARCH PURPOSES THROUGH NONINVASIVE PROCEDURES ROUTINELY EMPLOYED IN CLINICAL PRACTICE NOT REQUIRING -- I DON'T KNOW IF THAT WAS ALL SUPPOSED TO CARRY OVER. MAYBE IT WAS. THIS IS COLLECTION OF INFORMATION THROUGH NONINVASIVE PROCEDURES AND INTERVENTIONS ROUTINELY EMPLOYED IN CLINICAL PRACTICE AND NOT REQUIRING ADDITIONAL ANESTHESIA OR SEDATION. SO AGAIN, SOME OF THIS COMES FROM ONE OF THE CURRENT EXISTING CATEGORIES BUT WE HAVE BROADENED IT A LITTLE BIT OR TRIED TO BROADEN IT A LITTLE BIT, AND I WOULD SAY THAT THE CHANGES HERE FROM THE CURRENT LIST, EXAMPLE C ABOUT MRIs, WE'VE REFINED THE WORDING A LITTLE BIT TO SAY WHAT WOULD BE ACCEPTABLE AS IN MY OPINION AS MINIMAL RISK. CATEGORY F, EXPOSURE TO IONIZING RADIATION. BASICALLY THE OLD LIST SAID NO X-RAYS WHATSOEVER COULD BE EXPEDITED, AND HERE WE'VE PROPOSED EXPOSURE TO A LEVEL OF X-RAY THAT'S TYPICALLY ASSOCIATED WITH THE SINGLE CHEST X-RAY PROVIDED APPROPRIATE SHIELDIG TECHNIQUES ARE EMPLOYED. AT OUR LAST SACHRP MEETING, THERE WAS A EXAWL FOR US CALL FOR US TO JUSTIFY THIS AND TO GIVE SOMETHING TO SUPPORT THE IDEA IT WOULD BE MINIMAL RISK. THE BEST I COULD FIND WITH THE HELP OF SOME COLLEAGUES WHO ARE RADIOLOGISTS WERE LOOKING AT THE NRC'S ANNUAL ALLOWABLE EXPOSURE GUIDELINES FOR MEMBERS OF THE PUBLIC, WHICH IS AT 1MS, AND THAT WAS THE BEST I COULD DO IN TERMS OF JUSTIFYING THAT. BUT IT DOES GIVE US A GOVERNMENT DOCUMENT THAT TALKS ABOUT ALLOWABLE LIMITS AND FALLS WELL WITHIN THOSE. I DON'T KNOW IF THAT WILL SATISFY BUT THAT WAS THE BEST WE COULD COME UP WITH. BUT THERE CERTAINLY WAS ON THE PART OF THE SUBCOMMITTEES A DESIRE TO SEE SOME LOWER ALLOWABLE LIMIT ON X-RAY BEING ALLOWED. WE FELT THERE WERE A LOT OF STUDYS THAT WOULD BE EXPEDITED EXCEPT THEY REQUIRED ONE DENTAL BITEWING OR ONE CHEST X-RAY OR YOU KNOW, ONE SCAN, SOMETHING THAT THAT WAS THE ONLY THING HOLDING IT BACK, AND THAT WITH APPROPRIATE PARAMETERS, WE THOUGHT THAT WOULD BE ALLOWABLE. AND I MAY HAVE MISSPOKE, SO IF THAT'S -- DOESN'T -- >> THAT'S EQUAL TO TWO HOURS RIDE ON AN AIRPLANE. >> [INAUDIBLE] >> I WOULD DEFER TO THE RADIOLOGISTS OR NUCLEAR MEDICINE PEOPLE ON THAT. BUT FORGET THAT I SAID DE EXSM A, BECAUSE WHAT WE'RE REALLY INTERESTED IN IS WHAT THE LIMIT WOULD BE IN TERMS OF EXPOSURE TO RADIATION REGARDLESS OF WHETHER IT WAS A DENTAL X-RAY OR CHEST X-RAY OR SOME OTHER SCAN THAT INVOLVED EYE NIED NATIONAL NETWORK OF NATIONAL NETWORK OF INVOLVED IONIZING RADIATION. THE GOAL WAS TO PUT THE CAP ON THAT, NOT TO SAY WHAT TYPES OF X-RAYS WERE ALLOWABLE. >> WHEN I WAS READING OVER THIS TH AGAIN, I GOT CONFUSED BETWEEN 6 AND 7, BECAUSE E IS ACTUALLY REPEATED VERBATIM AS A IN 7, AND THAT MIGHT JUST BE AN ERROR, ONE OF THEM SHOULD HAVE BEEN DELETED, BUT THEN I WAS LOOKING AT D AND E IN 7 AND TRYING TO FIGURE OUT WHY THOSE WEREN'T IN 6. I MEAN, PEOPLE WEIGH THEMSELVES AND MEASURE THEIR HEIGHT, BUT IT STIM SEEMS LIKE THAT COULD STILL SEEMS LIKE SOMETHING THAT COULD BELONG IN 6, MEASURING COGNITIVE FUNCTIONING SEEMS LIKE IT BELONGS IN 6. SO I SUSPECT I WAS SOMEBODY ARGUING FOR SEPARATING 6 AND 7 IN THIS WAY, BUT WHEN YOU LOOK AT THE EXAMPLES, I'M NOT SURE IT'S ALL AS NEATLY SEPARABLE AS IT MIGHT BE. >> YEAH, I THINK YOU OR SOMEBODY THAT LOOKED LIKE YOU MAY HAVE ENCOURAGED US TO SEPARATE THIS OUT IN THE PAST. BUT YOU WEREN'T THE ONLY ONE. WE HAD SQUISHED A LOT INTO ONE CATEGORY. THEY WEREN'T ALL ALIKE THINGS. SO THIS WAS THE ATTEMPT AT SEPARATING OUT. I HONESTLY CANNOT RECALL IF SOME OF THAT REDUNDANCY WAS DONE PURPOSELY OR WAS SIMPLY A CUT AND PASTE ERROR TO A LARGE EXTENT. I'M NOT SO WORRIED IF THERE IS A LITTLE BIT OF DUPLICATION. THE BOTTOM LINE IS DOES IT FIT INTO UP WITH OF ONE OF THE CATEGORIES BUT IF THE DUPLICATION DOESN'T MAKE ANY SENSE, WE CAN REMOVE IT FROM ONE OR THE OTHER. I STILL THINK THERE IS SOME UTILITY IN HAVING THESE AS TWO SEPARATE CATEGORIES EVEN IF THE CATEGORIES NEED SOME CAT IF THE EXAMPLES NEED SOME CLARIFYING. IT REALLY WAS BECOMING ONE VERY BIG UNWIELDY CATEGORY. >> ANOTHER SMALL NUANCED POINT UNDER THE MRI. I THINK A LOT OF PLACES ARE MOVING TOWARDS USING THEIR RESEARCH M Rs OR RESEARCH PROTOCOLS JUST TO UNLOAD THE CLINICAL. THOSE ARE OFTEN SET DIFFERENTLY, THEY'VE JUST BOUGHT DIFFERENT EQUIPMENT, THEY MAY HAVE A 7T SCANNER INSTEAD OF A 3T, AND I THINK THAT THAT ACCEPTED CLINICAL USE GUIDELINES MIGHT BE INHIBITING. I LIKE THAT WITHOUT USE OF CONTRAST, I THINK THAT'S IMPORTANT, BUT I THINK THE SEQUENCE PARAMETERS MAY BE DIFFERENT ON SOME OF THOSE RESEARCH SCANNERS. >> THE OLD CATEGORY WAS A BIT MORE VAGUE, IT CERTAINLY DIDN'T HAVE THIS LEVEL OF SPECIFICATION ABOUT WHAT WAS ALLOWABLE. I WOULD REALLY DEFER TO THE GROUP TO SAY WHAT THEIR COMFORT LEVEL IS WITH LOOSENING OR TIGHTENING WHAT TYPES OF MRI SES COULD BE EXPEDITED. I JUST DON'T HAVE THE EXPERTISE TO -- >> I THINK WE PUT THAT IN IN PART BECAUSE THERE MIGHT BE INVESTIGATIONAL COILS BEING USED. WE SEE A LOT OF STUDIES WHERE THEY'RE TESTING NEW SEQUENCES. I THINK THE IMPORTANT PARAMETERS, I'VE BEEN TOLD IT'S THE SPECIFIC ABSORPTION RATE, THE SAR, WHICH I THINK IS HARDER TO SPECIFY IN THIS LANGUAGE. BUT JUST TRYING TO KEEP IT SO THAT IF THE MRI WAS BEING USED, IT WAS WITHIN WHAT WOULD NORMALLY BE USED CLINICALLY AND NOT INVESTIGATIONALLY. >> DAVID, IS THERE ANYTHING REASON TO HAVE ADDITIONAL GENERAL ANESTHESIA OR SEDATION? WE'VE ALREADY COVERED IN 5, SECONDARY -- OR ADDITIONAL COLLECTIONS. >> YEAH, THAT MAY BE A CUT AND PASTE ERROR WHEN I WAS SPLITTING IT INTO TWO. >> LINE 98. >> YEAH. >> YOU COULD EVEN JUST -- YEAH. >> WELL, I WILL SAY THE ONLY THING, STEPHEN, IS THAT UNDER THE CURRENT LIST, THE MRI HAD TO BE WITHOUT SEDATION. >> SO I WASN'T TO OBJECTING TO WITHOUT GENERAL ANESTHESIA OR SEDATION, I THINK THOSE ARE FINE EVEN THOUGH THEY WON'T APPLY MOST TIMES. IT'S JUST THE WORD ADDITIONAL. >> OH, I GOTCHA. >> OKAY. LET ME -- SO I DON'T HEAR A CONSENSUS FOR REWRITING THE BUN MRI, SO FOR NOW, I'LL JUST LEAVE IT. THEN 7 IS COLLECTION OF INFORMATION OF ACTIVITIES PERFORMED IN DAILY LIFE IN INDIVIDUALS AND GROUPS WHOSE HEALTH WILL NOT BE ADVERSELY AFFECTED BY THE ACTIVITIES. SO PART OF THAT BEGINNING CHANGED BECAUSE FOR SOME OF THE EXAMPLES IN HERE, WE HAD SOME LIVELY DISCUSIONS THE LAST MEETING THAT SOME OF THESE WERE JUST SORT OF OPENING THE DOORS A BIT TOO FAR. FOR EXAMPLE, EXAMPLE C, THE MANIPULATIONS OF DIET AND LIFESTYLE, THERE WAS CONCERN THAT WITHOUT SOME ADDITIONAL RESTRICTIONS AROUND THAT, THAT IT COULD BE ABUSED. EVEN THOUGH WE'RE LOOKING AT A LIST THAT'S SUPPOSED TO BE ONLY IN THE CONTEXT OF MINIMAL RISK RESEARCH. HOWEVER, WE'VE DONE THAT. SO WE'VE GOT COLLECTIONS OF ACTIVITIES FOR DAILY LIFE, IN INDIVIDUALS AND GROUPS WHOSE HEALTH WILL NOT BE ADVERSELY AFFECTED BY THE ACTIVITIES, AND THEN YOU CAN SEE THE EXAMPLES HERE. MANY OF THESE EXAMPLES ARE JUST THE SAME AS THEY WERE THE LAST TIME WE MET. >> SO I THINK I MIGHT BE HAPPY WITH 6 AND 7 SEPARATED, IF WE MOVE MEASURES OF COGNITIVE FUNCTIONING UP TO 6. BECAUSE THAT DOESN'T SPECIFY WHAT THE ACTIVITY IS RS, AND THE CATEGORY IS LET'S START WITH ACTIVITIES THAT PEOPLE USUALLY DO IN DAILY LIFE AND PEOPLE DON'T SORT OF ORDINARILY GO AROUND MEASURING THEIR COGNITIVE FUNCTIONING, SO THAT SEEMENT TO FIT BETTER IN 6. >> SURE. WE'LL RECONCILE THE DUPLICATION IN E. I THINK IT SHOULD REALLY ONLY BE IN ONE PLACE. 6E. 6E AND 7A ARE THE SAME. >> YEAH, ARE PEOPLE COMFORTABLE WITH THIS MOVING DOWN TO 7, WHERE I THINK IT HAS A BETTER HOME? OKAY. SO THAT'S 7. AND THEN 8, ACTIVITIES STATISTICAL AND DATA COORDINATING CENTERS OR BIOSPEPS MEN -- NOT RESPONSIBLE FOR THE PRIMARY OVERSIGHT OF THE COMMITTEE -- WHICH MAY BE ONGOING AT OTHER SITES. AND THEN SORRY, AFTER THE BREAK, WE HAVE THE EXAMPLES, CENTRAL DATA COORDINATING CENTERS, COORDINATING CENTER, DATA COORDINATING CENTER, NOTE OTHERWISE PARTICIPATING -- INTERACTING DIRECTLY WITH SUBJECTS. >> SO WHAT'S MEANT BY PRIMARY OVERSIGHT? >> THAT MEANS THAT -- NOW OF COURSE THIS MAY BE SHIFTING WITH THE NEW IRB REQUIREMENTS, BUT IN GENERAL, IF I WAS IN AN INSTITUTION AND WE WERE THE DATA COORDINATING CENTER BUT HAD NOTHING TO DO WITH ALL THE CLINICAL WORK AND THE COLLECTIONS THAT WE WEREN'T THE IRB THAT WAS OVERSEEING THE CLINICAL TRIAL THAT WAS PREPROA DUESING THE DATA, JUGS OVERSEEING THE WORK OF THE DATA COORDINATING CENTER AS THE CENTRAL SITE THAT'S GETTING AND MANAGING AND -- MANAGING THE DATA. >> I'M OKAY WITH THAT. ALTHOUGH IT COULD BE READ TO MEAN THAT IT HAD THE PRIMARY OVERSIGHT OF THE STUDY WHICH WAS THEY WERE PRIMARILY RESPONSIBLE FOR THE COLLECTION OF THE DATA AND THE DATA ANALYSIS, AND THAT WOULD MAKE THIS UNHELPFUL. >> I CAN THINK ABOUT THAT AND WORK OVER THE BREAK. I'M NOT SURE WHERE BEST TO MASSAGE THIS A LITTLE BIT BUT I THINK I UNDERSTAND THE CONCERN. >> I HAD A COUPLE OTHER QUESTIONS BECAUSE THIS KIND OF COORDINATING CENTER CAN BE HANDLING VERY SENSITIVE DATA. I'M SORT OF WONDERING SORT OF HOW THE IN MY OPINION MALL RISK STANDARD APPLIES HERE, WHETHER IT SAYS ANYTHING THAT'S RELEVANT TO THAT. BECAUSE THEY NEED TO BE HANDLING THE DATA IN A FASHION THAT'S SECURE AND PROPERLY -- [INAUDIBLE] AND ALSO IT SPEAKS TO NOTHING ABOUT THE DISTRIBUTION OF THE DATA. BECAUSE THAT'S VERY IMPORTANT. SO I DON'T KNOW WHO'S SUPPOSED TO BE OVERSEEING THE QUALITY OF THE DATA MANAGEMENT AND THE RULES FOR DISTRIBUTION OF DATA IN PARTICULAR WAYS. IF REALLY WE'VE ONLY ADDRESSED THE COLLECTION OF THE DATA, AND HERE WE HAVE A COORDINATING CENTER THAT IS VERY VAGUELY SPECIFIED. >> JIM, DID YOU HAVE SOMETHING TO ADD TO THAT BEFORE I RESPOND? >> ONLY TO SAY THAT THE ROLE OF THE IRB TYPICALLY IN THE REVIEW OF A STATISTICAL AND DATA COORDINATING CENTER FOCUSES ON CONFIDENTIALITY, AND THAT'S THE SAME SORT OF ASSESSMENT OF MINIMAL RISK THAT WOULD TAKE PLACE IN ASSESSING WHETHER THIS COULD BE EXPEDITABLE. I KNOW MY OWN EXPERIENCE WITH MY OWN IRB, WE DID CONTINUING REVIEWS, NOT BECAUSE THE IRB FELT IT WAS NECESSARY, BUT BECAUSE IT WAS REQUIRED BY THE REGULATIONS. SO I THINK THE ISSUES THAT YOU'VE RAISED ARE COVERED IN THE KIND OF INFORMATION THAT HAS TO BE SUBMITTED FOR AN ASSESSMENT OF AN EXPEDITABLE REVIEW. >> JUST IN TERMS OF THE CONTEXT OF THE FINAL RULE, I'M STRUGGLING WITH WHY THESE WOULD EVER BE REVIEWED AS SEPARATE SITE AND REQUIRE THEIR OWN IRB REVIEW AS OPPOSED TO REVIEWING IT AS PART OF THE WHOLE PROTOCOL. >> I THINK THAT'S A GOOD QUESTION. THIS IS CERTAINLY ONE OF THE OLDER CATEGORIES AND WAS IMAGINED WHEN THERE WAS NO SINGLE IRB MANDATE. I SUPPOSE THERE MAY BE A QUESTION, SAY IN A MULTISITE CLINICAL -- A MULTISITE STUDY WHERE A DIFFERENT ORGANIZATION WILL SERVE AS THE STATISTICAL CENTER OR THE DATA COORDINATING CENTER, WHETHER OR NOT THEIR WORK WOULD BE CONSIDERED PART OF WHAT THE SINGLE IRB FOR THE MULTISITE RESEARCH IS LOOKING AT OFFER WHETHER THEY WOULD FALL UNDER SOME SORT OF EXCEPTION FROM THE SINGLE IRB REQUIREMENT, BUT NOW I'M REALLY JUST THINKING OUT LOUD, BUT ON A VERY SUPERFICIAL LEVEL LOOKING AT THE SINGLE IRB REQUIREMENT, YOU COULD SAY IT WILL JUST BE FOLDED IN AS PART OF WHAT THAT SINGLE IRB IS REVIEWING, BUT SOMETIMES THAT COORDINATING CENTER IS SO -- IT'S DISTINCT IN EVERY OTHER WAY FROM WHAT ALL THE IMPLEMENTATION SITES, THE SITES DOING PRIMARY DATA COLLECTION ARE DOING THAT IT WOULD BE SORT OF AN AWKWARD THING TO TACK ON UNDER THE SINGLE IRB OR COULD CONCEIVABLY BE A STRANGE THING TO TACK ON. >> [INAUDIBLE] >> IT'S SORT OF -- THEY'LL HAVE A COORDINATING -- ANYTHING THAT'S GINLY -- UNLESS IT SPECIFICALLY FALLS INTO ONE OF THE EXEMPTIONS FOR THE SINGLE IRB MANDATE, IF THEY'RE CONSIDERED A SITE, IT MAKES IT -- THEY WOULD FALL UNDER THE SAME -- [INAUDIBLE] >> THEY MAY BE FUNDED IN DIFFERENT WAYS. >> I DON'T COMPLETELY DISAGREE WITH YOU, STEPHEN, BUT I WOULD SAY I WOULD PRESERVE THIS CATEGORY BECAUSE THERE MAY BE CIRCUMSTANCES WHERE IT DOES FIT GOING FORWARD AND I'D HATE TO HAVE LOST IT BECAUSE WE THOUGHT IT MIGHT FALL UNDER A SINGLE IRB. CATEGORY 9 IS JUST ONE OF THE OLD CATEGORIES THAT WE RETAINED. >> I HAVE A QUESTION ABOUT CATEGORY 9. >> YES. >> SO IS THERE ANY IMPLICATION -- I ASSUME THAT PEOPLE KNOW THAT THIS IS HAPPENING? THAT -- IS KNOWN TO THE PERSON WHO'S BEING -- [INAUDIBLE] >> WELL, SO NOT NECESSARILY. I MEAN, IF YOU LOOK AT WHAT MAKES IT NON-EXEMPT -- WELL, ONCE IT'S NON-EXEMPT, IT WOULD HAVE TO FIT UNDER THE INFORMED CONSENT REQUIREMENTS AT 116, SO EITHER OBTAINING PROSPECTIVE CONSENT OR OBTAINING A WAIVER, AND IF IT WAS A CASE OF -- THE IRB WOULD HAVE TO CONSIDER WHETHER OR NOT ANY SORT OF DISCLOSURE WOULD BE NEEDED AFTER THE RESEARCH. BUT IT WOULD HAVE TO MEET THE 116 CRITERIA, WHICH -- YEAH. CATEGORY 10 IS A LONG ONE. SURVEY, INTERVIEWS, SELF-REPORTS, ET CETERA. THIS IS PARTLY FROM THE OLD LIST BUT WE'VE EXPANDED ON IT. AGAIN, THIS WOULD BE A NUMBER OF DIFFERENT TYPES OF ACTIVITIES THAT ARE PARTLY HERE BECAUSE THEY CROSSED SOME SORT OF THRESHOLD THAT MADE THEM NON-EXEMPT, AND WE'VE GOT A FAIRLY LENGTHY LIST OF EXAMPLES HERE. >> DON'T YOU HAVE A LOT OF LANGUAGE THAT'S ACTUALLY UNDER 11? MANIPULATION OF THE SUBJECT ENVIRONMENT AND -- ISN'T THAT REALLY LANGUAGE THAT BELONGS UNDER 11? >> SO I WOULD JUST -- IT MIGHT BE AND 11 IS SORT OF ITS OWN ANIMAL, SO THERE ARE A NUMBER OF EXPEDITED CATEGORIES UNDER THE OLD LIST AND UNDER THE PROPOSED NEW LIST THAT ARE MADE TO COVER THINGS THAT FOR ONE REASON OR ANOTHER DID NOT MAKE IT AS EXEMPT, AND CATEGORY 11 IS THAT NEW ONE I ALLUDED TO FOR THINGS THAT ARE BENIGN BEHAVIORAL INTERVENTIONS BUT DON'T MEET THE REQUIREMENTS TO BE EXEMPT AS A BENIGN BEHAVIORAL INTERVENTION. SO THERE WILL ABSOLUTELY BE SOME OVERLAP THERE THAT I DID TO THE HAVE A CHANCE TO SORT ALL OF IT OUT YET AND IT COULD BE A SITUATION WHERE IT'S IMPORTANT THAT IT BE IN A SENSORY PETEED IN 10 OR 11 AND THERE MAY BE SOME CASES WHERE I JUST NEEDED TO REMOVE IT FROM ONE OR THE OTHER. >> I THINK IT'S VERY CONFUSING, THAT LANGUAGE IN 10 AND THEN HOW BOTH THE NEW EXEMPT CATEGORY AND 11, BECAUSE IT LOOKS LIKE YOU DON'T KNOW QUITE WHERE -- >> BUT PART OF THAT HAS TO DO WITH THE PROBLEM THAT WE'VE NOW BECOME AWARE OF, OF THE DIFFERENCE BETWEEN THE BENIGN BEHAVIORAL INTERVENTION AND THE METHOD OF DATA COLLECTION ABOUT THE BENIGN BEHAVIORAL INTERVENTION BECAUSE A LOT OF THE STUFF IN 10 IS METHODS OF DATA COLLECTION. >> RIGHT, BUT THIS IS THE INTERVENTION. >> WE COULD REDO 10 AND 11 TO CORRESPOND TO EX-EMSES EXEMPTIONS 2 AND 3, LITERALLY. PARSING OUT THE EXAMPLE, BECAUSE THAT DOES CLARIFY. >> WE COULD. IF THAT MADE MORE SENSE. I DON'T KNOW IF WE SORT OF REACH A POINT WHERE WE END UP WITH ONE SUPER CATEGORY THAT'S ALSO VERY HARD TO PICK APART OR TO FIND WHAT YOU'RE LOOKING FOR IN IT, BUT I'M LESS WORRIED ABOUT THAT THAN MAKING SURE THE LIST IS CLEAR AND THAT PEOPLE UNDERSTAND. SO SO BEFORE DEALING WITH THAT PROBLEM, ANY QUESTION, CONCERN, COMMENTS ABOUT THE EXAMPLES UNDER CATEGORY 10? >> METHOD WITH IS INTERVIEWS, QUESTIONNAIRE, SURVEYS, THE WAY YOU ELICIT INFORMATION AND THE TOPICS ON WHICH YOU CAN ELICIT INFORMATION. AND THAT'S A LITTLE CONFUSING, ESPECIALLY BECAUSE YOU HAVE TOPICS IN TWO PLACES. YOU HAVE SOME TOPICS UNDER B AND THEN YOU HAVE ANOTHER BUNCH OF TOPICS UNDER F. IT'S A VERY -- THERE ARE SOME TOPICS THAT YOU MIGHT BE INTERESTED IN THAT AREN'T EVEN MENTIONED HERE. SO I REALLY WONDER IF YOU DON'T WANT TO SIMPLY CONFINE YOURSELF TO THE METHOD OF ELICITATION IN 10. >> I'M JUST TAKING NOTES. IT LOOKS TO ME LIKE VARIOUS KINDS OF DISCIPLINARY AREAS ADVOCATED FOR THEIR TOPICS. >> THAT PROBABLY IS A FAIR ASSESSMENT. >> BUT I DON'T THINK THEY REALLY BELONG THERE, OR IF SO, THEN YOU OUGHT TO CONSOLIDATE THEM IN SOME WAY AND COMMENT ON IT IN SOME WAY TO SAY THESE ARE POTENTIAL TOPICS, BUT I'D KEEP IT CLEAN MYSELF AND WORRY ABOUT THE TOPICS UNDER RISK. >> I CAN TRY TO STRIP THIS BACK A BIT. I DON'T KNOW IF -- YEAH, I CAN TRY TO PULL THAT BACK A BIT. >> BEFORE DAVID TAKES THAT CHARGE, IS THERE ANY REASON THAT SPECIFIC AREAS OR TOPICS SHOULD BE EXPLICITLY EXPEDITABLE JUST BY THE NATURE OF THEIR -- THE TOPIC ITSELF? >> I DO THINK THAT THAT IS AN ISSUE THAT OFTEN COMES UP WHERE IT IS A SURVEY -- ADOLESCENT SEX SURVEYS, THAT IS THE EXAMPLE THAT PEOPLE GET AGITATED ABOUT, CERTAINLY WOULDN'T WANT IT TO BE EXEMPT BECAUSE IT'S SENSITIE BUT IT MAY BE APPROPRIATE WITH OTHER REVISIONS TO PUT IT INTO THIS CATEGORY, AND I THINK HAVING SOMETHING THAT SAYS IT'S OKAY TO DO SOMETHING SENSITIVE AND EXPEDITE IT CAN BE HELPFUL. ALL OF THE DIFFERENT CRITERIA HAVE TO ALWAYS BE ATTENDED TO, BUT THE KIND OF THING HAVING SOME PERMISSION PROVISION AT WE ARE, IN FA CT, INCLUDING THESE IF EVERYTHING ELSE IS MET BY THE REQUIREMENT. >> CAN YOU USE YOUR MIC? I'M GETTING MESSAGS. REMEMBER TO SPEAK INTO YOUR MIC. >> PERHAPS SOME GENERAL MENTION THAT THIS CAN INCLUDE SENSITIVE TOPICS, CAN INCLUDE VULNERABLE POPULATIONS, I GUESS. I DON'T KNOW HOW FAR YOU'RE GOING TO BE COMFORTABLE WITH THIS. >> SO WE'VE ALREADY SAID THESE CAN'T MEET THE EXEMPTION UN104D2, SO YOU'VE ALREADY SORT OF RATCHETED IT UP A LITTLE. SO I GUESS WE COULD HAVE EXAMPLE EXAMPLES, WE COULD PUT SOME EXAMPLES OF SENSITIVE INFORMATION THERE SO PEOPLE WERE CLEAR THAT THOSE WERE POTENTIALLY DOABLE HERE. I'M NOT SURE THE CRITERIA ITSELF ITSELF -- >> AS I'M SITTING HEERY FLECTING ON IT, I DO THINK THIS IS A CATEGORY WHERE LOADING MORE IN IS QUITE HELPFUL. BECAUSE PEOPLE, WHEN WE STRIP IT DOWN, PEOPLE WILL MAKE PRESUMPTIONS ABOUT WHAT WE DID AND DID NOT MEAN TO BE COVERED BY IT, AND I KNOW THAT SOME OF THE THINGS IN HERE, INDEED THEY WERE ADVOCATEED BY PEOPLE WHO CAME AT THE LIST WITH A CERTAIN PERSPECTIVE, BUT I THINK THAT'S BECAUSE THEY HAD EXPERIENCE WHERE AN IRB WOULDN'T EXPEDITE SOMETHING THEY FELT VERY CLEARLY WAS MINIMAL RISK BECAUSE IT WAS NOT LISTED OUT IN A CATEGORY. SO I THINK THAT'S THE DIFFICULTY WITH LISTS OF EXAMPLE, IS THAT THERE WILL BE IRBs THAT IF THEY DON'T SEE IT ON THE LIST OF EXAMPLES, WE'LL SIMPLY SAY THAT'S NOT GOING TO BE EXPEDITED. >> YOU MAKE THAT POINT IN THE BEGINNING. EXAMPLES ARE EXAMPLES, THEY'RE NOT CRITERIA. OR CATEGORIES. >> I KNOW. >> SEPARATE OUT METHODS AND EXAMPLES OF TOM IX. IN SOME RATIONAL WAY. BECAUSERIGHT NOW THEY'RE KIND OF COMBINED. >> JUST LOOKING AT IT, B, C, IF. , G AND MAYBE H ARE ALL TOPICS, AND A, D AND E ARE METHODS. >> WHAT DID YOU LIST AS METHODS? >> A, D AND E. >> THANKS. OKAY. >> OKAY. SO I'LL WORK ON THAT. NANCY, THANKS FOR THAT QUICK READ OF HOW YOU THINK THE CATEGORIES MIGHT FOLLOW UP. THAT'S JST HELPFUL SO THAT WHEN I GO BACK AND LOOK AT MY NOTES LATER, IT MAKES SENSE. I'M GOING TO MOVE ON TO CATEGORY 11 JUST BECAUSE I'M MINDFUL OF THE TIME. SO 11 IS THE LANDING GROUND FOR BENIGN BEHAVIORAL INTERVENTIONS THAT ARE TOO LONG OR MAYBE THAT INVOLVE CHILDREN OR WHATEVER THE CASE MAY BE, AND GARY CHADWICK HAD THE GREAT SUGGESTION OF TAKING OUR EXAMPLES OR OUR QUESTION FROM THE DOCUMENT MICHELE RAN THROUGH EARLIER, AND FOR THE THINGS LIKE THE EXAMPLES ARE DRAWN FROM THAT AND BASICALLY SAID IT DOESN'T FIT THE EXEMPTION BECAUSE IT'S NOT BRIEF IN DURATION SO WE'VE PUT IT HERE. SO THE BASIC OF NUMBER 11 IS BEHAVIORAL INTERVENTIONS THAT ARE NOT ELIGIBLE FOR EXEMPTION IS BEHIND BEHAVIORAL INTERVENTION UNDER 104D3, AND THEN THE EXAMPLES JUST WALK THROUGH THE THINGS THAT WE SAID WOULD DISQUALIFY IT. >> SO ALL OF YOUR EXAMPLES EXAMPLE START OUT BENIGN BEHAVIORAL, BUT YOUR FIRST CATEGORY DOESN'T START OUT BENIGN. AND I THINK THAT KIND OF GOES TO THE QUESTION I HAD ABOUT IT, WHICH IS OKAY, SO HOW DO WE DECIDE IF SOMETHING BELONGS IN THIS CATEGORY OR HAS TO GO TO FULL COMMITTEE, AND I THINK IT'S THAT BENIGN QUALITY ABOUT IT THAT'S SUPPOSED TO BE THE DISTINCTION HERE. >> YEAH, THANKS FOR RAISING THAT. I REALLY DID WRESTLE WITH IT BECAUSE I DIDN'T WANT TO START OUT BY SAYING BENIGN BEHAVIORAL INTERVENTIONS THAT AREN'T ELIGIBLE FOR EXEMPTION -- ALTHOUGH I COULD. UNDER THAT THING. THAT MIGHT BE THE EASIEST FIX. I STARTED TO WRITE THE EXAMPLES WITHOUT THE USE OF BENIGN AND THAT SEEMED TOO BROAD, BEHAVIORAL INTERVINGSES THAT ARE NOT BRIEF IN DURATION WAS JUST TOO OPEN-ENDED. SO IT MIGHT MAKE SENSE TO JUST CALL THESE BENIGN BEHAVIORAL INTERVENTIONS THAT ARE NOT EXEMPT. I DON'T KNOW IF THAT WOULD CREATE MORE CONFUSION THAN -- >> YOU COULD CALL THEM BEHAVIORAL INTERVENTIONS WITH FEATURES THAT MAKE THEM NOT ELIGIBLE FOR EXEMPTION UNDER BENIGN, AND THEN SAY EXAMPLES MIGHT BE INVOLVING CHILDREN, INVOLVING INDIVIDUALS. BECAUSE YOU'VE GOT THIS BENIGN BEHAVIORAL INTERVENTION THING REPEATED OVER AND OVER AND OVER. SO PUT IT IN THE BEGINNING AND THEN LIST THE EXAMPLES IN A SIMPLER WAY AND I THINK THINK IT WILL BE EASIER. >> I'M NOT SURE I ADPREE COMPLETELY BECAUSE BAWS SOMETIMES AN EXAMPLE IS ABOUT SOMETHING THAT IS A BENIGN BEHAVIORAL INTERVENTION BUT IT DOESN'T MEET THE CRITERIA OF THE EXEMPTION FOR SOME OTHER REASON. LIKE YOU DIDN'T GET PROSPECTIVE CONSENT OR E WHICH NEEDS TO BE CLARIFIED A LITTLE BECAUSE IT'S NOT THE INTERVENTION THAT'S NOT LIMITED TO VERBAL OR WRITTEN RESPONSES, IT'S HOW THE -- IT'S THE DATA COLLECTION ABOUT THE INTERVENTION. BUT IT STILL MIGHT BE A BENIGN BEHAVIORAL INTERVENTION BUT IF THE DATA COLLECTION DOESN'T MEET THOSE CRITERIA, THEN IT DOESN'T FALL UNDER THE EXEMPTION BUT IT'S STILL A BENIGN BEHAVIORAL INTERVENTION IN OTHER WAYS. SO I DON'T THINK WE GET OUT OF THE CONUNDRUM BY JUST TAKING BENIGN OUT OF IT. DO WE NEED THE EXAMPLES HERE AT ALL ?L IF IT'S JUST A REFLECTION OF THE BENIGN BEHAVIORAL EXEMPTION, WE JUST SAY THINGS THAT DON'T SATISFY THAT EXEMPTION, PERIOD, RIGHT, BECAUSE ALL OF THE EXAMPLE EXAMPLES ARE THINGS WE LAY OUT UNDER THE OTHER EXEMPTION. OR THIS IS NOT AN EXEMPTION, EXCUSE ME. YOU HAVE SEE WHAT I MEAN? WE'RE NOT ADDING ANY NEW INFORMATION HERE, WE'RE JUST SAYING IT'S THE FLIP OF THE EXEMPTION. SO I DON'T KNOW THAT WE NEED TO LIST THEM OUT AGAIN. >> WE TALKED ABOUT THE SUBCOMMITTEE, THIS ENDED UP BEING THE CONSENSUS, I THINK WE STARTED WITH THAT POSITION AND PEOPLE WERE WORRIED THAT WE HAD ALMOSTER WHERE ELSE PRETTY LENGTHY EXAMPLE, BUT THAT MAY WORK JUST AS WELL. I COULD GO EITHER WAY. >> IT GETS IMPORTANT TO LEAVE THE EXAMPLES SO THAT PEOPLE UNDERSTAND WHY IT DIDN'T MEET THE EXEMPTION. SUCH AS, OKAY, IF YOU SAY BENIGN BEHAVIORAL INTERVENTIONS THAT ARE NOT ELIGIBLE FOR EXEMPTION AS BENIGN BEHAVIORAL INTERVENTION, YOU COULD GET CAUGHT IN A CIRCULAR LOOP THERE. >> MAYBE THE PROBLEM IS CALLING THEM EXAMPLES, HERE IS DIFFERENT THAN IN THE OTHER SCENARIO, BECAUSE THESE ARE NOT JUST ILLUSTRATIVE EXAMPLES. THESE ARE THE SITUATIONS IN WHICH YOU WOULD NOT BE ELIGIBLE FOR THE EXEMPTION, RIGHT? WE'RE KIND OF JUST LISTING OUT TEACH KIND OF REVERSE OF THE EXEMPTION, AND SO IT'S MORE DEFINITIONAL. THERE'S NOT SOME OTHER THING. I'M NOT CLEARLY DESCRIBING MY POINT HERE BUT THE IDEA BEING IN ALL THE OTHER EXAMPLES THAT WE'RE PROVIDING, THEY'RE JUST ILLUSTRATIVE, WE HAVEN'T PUT FORTH EVERY POSSIBLE EXAMPLE, RIGHT? BUT I THINK HERE, WE'RE SAYING THESE ARE THE EXAMPLES THAT WOULD NOT SATISFY -- >> EXEMPTION. >> YEAH. >> IT'S MORE DEFINITIONAL. SO YOU COULD JUST KEEP IT AS PART OF THE ACTUAL CATEGORY AND NOT AS AN EXAMPLE. >> I'D ALSO DELETE F ENTIRELY, BECAUSE FIRST OF ALL IT'S STATED WRONGLY. BUT IT'S SOMETHING THAT'S AN ISSUE FOR ANY EXEMPT CATEGORY, AND IT SORT OF STICKS OUT BEING INCLUDED HERE WHEN WE'RE NOT INCLUDING IT IN, SAY, 10 OR SOMETHING LIKE THAT. SO JUST DELETE OUT. >> THE CONSENSUS IS TO BE BENIGN BEHAVIORAL INTERVENTIONS THAT ARE NOT ELIGIBLE FOR EXEMPTION BECAUSE A, B, C -- >> YEAH. >> THEN NANCY, WITH RESPECT -- WELL, MAYBE I'LL ASK YOU, MICHELE, BECAUSE YOU'VE BEEN WORKING ON THIS. DO WE LOSE ANYTHING BY -- IF F WAS -- >> I WANT TO THINK ABOUT THAT. BECAUSE THERE ARE THESE OTHER PROVISIONS THAT WE ACTUALLY KIND OF GLOSSED OVER UNDER PRIVACY PROTECTIONS AND LIMITED IRB REVIEW, SO IT MAY BE THAT IT'S IMPORTANT TO HAVE THIS IN HERE. >> IF IT IS, IT MIGHT ACTUALLY BELONG SOMEWHERE ELSE BECAUSE IT ALSO APPLIES TO 10 OR ANY OTHER CATEGORY THAT LET'S JUMP TO EXPEDITED BECAUSE IT CAN'T BE EXEMPT. BUT IT'S STATED HERE -- >> [INAUDIBLE] >> IT SHOULD BE "CAN READILY BE ASCERTAINED" RATHER THAN CANNOT. >> OKAY. I'LL THINK ABOUT THAT. 12 HAS CHANGED A LITTLE SINCE WE LAST SAW IT SO THIS IS SUBJECT DATABASES TO WHICH SUBJECTS HAVE PROVIDED PERSPECTIVE -- OR IT'S BEEN WAVE WAIVED BY THE IRB, AND WE HAVE SOME EXAMPLES HERE. >> [INAUDIBLE] THERE'S SOMETHING SORT OF ODDLY MISSING HERE. >> CAN I GO BACK TO F11 FOR JUST A SECOND BECAUSE IN THE DETERMINATION OF WHAT WE DO WITH THAT, I JUST REALIZED IT'S ACTUALLY INCORRECT IN ANOTHER WAY, BECAUSE IT IS OKAY TO RECORD INFORMATION THAT'S IDENTIFIABLE SO LONG AS THERE'S BEEN A LIMITED IRB REVIEW WITH PRIVACY PROTECTIONS. SO SO JUST JUST SAYING THAT IS NOT AN ADEQUATE CAPTURE OF THE PROBLEM. >> [INAUDIBLE] >> RIGHT. >> COW JUST POINT YOU COULD JUST POINT OUT THAT PROVISION AND SAY THAT DOESN'T MEET THE CRITERIA FOR THE PRIVACY OR WHATEVER IT IS, BECAUSE I THINK THAT'S WHAT YOU'RE SAYING. >> SO ON 12, IS IT WORTHWHILE MENTIONING, SO YOU'RE CREATING AND MAINTAINING DATABASES FOR SECONDARY RESEARCH. I MEAN, THERE'S NO END IN CREATING OR MAINTAINING A DATABASE ITSELF, SO SHOULD WE ADD THE CAVEAT THAT ARE NOT UNDER WHICH BROAD CONSENT WAS NOT SOUGHT? CREATING AND MAINTAINING SUCH DATABASES -- >> MIKE? >> I DON'T HAVE THE LANGUAGE FOR 104D D7 IN FRONT OF ME, BUT CREATION AND MAINTENANCE OF BIOREPOSITORIES AND I THINK DATABASES FOR SECONDARY RESEARCH FOR WHICH BROAD CONSENT IS SOUGHT. SO THIS OBVIOUSLY, IF YOU DON'T WANT THEM TO OVERLAP, YOU WOULD BE -- THIS WOULD BE ONE FOR SOUGHT AND IT COULD GO FOR- EXPEDITED REVIEW. OTHERWISE IT WOULD BE EXEMPT. >> [INAUDIBLE] IT SEEMS TO BE MAKING A DISTINCTION BETWEEN -- WITH 12 AND 13 BETWEEN CREATING THE DATABASE AND MAINTAINING DATABASE VERSUS USING THE DATABASE. >> RIGHT. AND THAT'S THE SAME AS THE EXEMPTIONS, D7, D8. SO I THINK IT PARALLELS IT. >> I'LL TAKE A LOOK AT THAT WITH THE REGULATION IN FRONT OF ME. I CAN TAKE A LOOK AT THE NEW REAL REUL RULE AND FIGURE OUT HOW THAT MAPS OUT BETWEEN 12 AND 13. SO 13 IS SECONDARY RESEARCH USES THAT ARE NOT EXEMPT UNDER THE NEW RULE. AND THIS IS A WHOLE NEW ONE THAT ONE OF THE SUBCOMMITTEE MEMBERS PUT FORWARD ONCE WE WENT DOWN THE ROUTE OF SAYING WE SHOULD HAVE SOMETHING FOR THE BENIGN INTERVENTIONS, WE LOOKED AT WHAT ELSE MIGHT HAVE A PROBLEM -- DIDN'T ALWAYS HAVE A CLEAR HOME ON THE CURRENT LIST SO THIS IS ALL NEW TO ALL OF YOU. >> ANOTHER WAY TO FIX 12 WITHOUT TALKING ABOUT BROAD CONSENT IS JUST TO MAKE REFERENCE TO SECTION 104D7, AND THAT WOULD MAKE THEM PARALLEL TO. >> OKAY. >> WE'RE NEAR THE END. SHOULD WE JUST PUSH THERE YOU FOR THE LAST FEW MINUTES? >> I THINK WE SHOULD PUSH THROUGH. >> OKAY, GOOD. SO THOSE ARE THE CATEGORIES ONE THROUGH 13. HOWEVER THEY END UP IN THEIR FINAL FORM WOULD BE FOR INITIAL REVIEW OF RESEARCH. NOW, UNDER THE CURRENT EXPEDITED LIST AND UNDER THE CURRENT COMMON RULE, WE HAVE STUDIES THAT STARTED OFF WITH THE FULL BOARD BUT UNDER CERTAIN CIRCUMSTANCES CAN HAVE THEIR CONTINUING REVIEW EXPEDITED. AND THE SUBCOMMITTEES WERE PRETTY CONSISTENT IN SAYING THAT WE'D LIKE TO MAINTAIN THAT. AND SO WE HAVE RETAINED IT AS CATEGORY 14, IT HAS BEEN GENERALLY WORKED TO MAKE SURE IT FITS WITH THE NEW REGULATIONS BECAUSE THERE ARE CERTAIN THINGS IN THE REGULATION THAT DON'T NEED CONTINUING REVIEW. IT COST CREATE DOES CREATE A LITTLE LOOP WHERE UNDER THE NEW EXPEDITED RULES, STUDIES THAT ARE EXPEDITED DON'T NEED CONTINUING REVIEW SO IT SEEMS A LITTLE ODD TO HAVE A REVIEW CATEGORY FOR EXPEDITED BUT AGAIN WE WANTED TO PRESERVE THAT. AND THAT WILL BE A MATTER FOR THE REGULATORS TO SORT OF SORT OUT HOW THEY WOULD IMPLEMENT THAT. BUT PRESUMABLY THINGS THAT WE'RE DOING CONTINUED REVIEW THIS WAY WOULD NOT, AT LEAST AS IT'S WRITTEN HERE, I THINK, WOULD HAVE TO CONTINUE TO COME FOR CONTINUING REVIEW ON AN ANNUAL BASIS. SO THAT WOULD INCLUDE RESEARCH THAT PEE RYE MAINS REMAIPS ACTIVE, THE FOOTNOTE THERE TALKS ABOUT WHAT THINGS STILL FALL UNDER THAT EVEN UNDER THE NEW RULE. BASICALLY STUDIES THAT HAVEN'T STARTED YET, NO SUBJECTS, NEW NEW RISKS, THAT'S ONE OF THE CURRENT ONES, AND THEN C WAS THE ONE THAT WE WERE MOST CONCERNED WITH, AS MUCH WORK AS WE'VE PUT INTO THE EXPEDITED REVIEW LIST, WE ARE SURE THAT THERE WILL END UP BEING STUDYS THAT GO TO THE FULL BOARD WHERE THE FULL BOARD SAYS THIS IS MINIMAL RISK, IT JUST WOULDN'T FIT A CATEGORY, IT DOESN'T NEED TO KEEP COMING BACK TO THE FULL BOARD. WE HAVE MADE IT CLEAR THAT THIS COULD INCLUDE STUDIES THAT UTILIZE A DEVICE THAT HAS BEEN DETERMINED TO BE NON-SIGNIFICANT RISK BY THE I RMENT B. AND I THINK THE LAST SENTENCE OF C WAS MEANT FOR ALL THREE -- MY MEMORY IS THAT WAS MEANT FOR ALL THREE OF THESE CATEGORIES. I DON'T KNOW WHY I LEFT IT STUCK IN RIGHT THERE. SO THOSE WOULD BE THE PROPOSED CONTINUING REVIEW THAT COULD BE EXPEDITED, AND THIS REALLY JUST IS IN AN ATTEMPT TO MAKE SURE THAT THINGS AREN'T BEING SENT FOR A FULL BOARD THAT AREN'T THE BEST USE OF THEIR TIME. >> SO DAVID, WHAT IS -- I KNOW WE DISCUSS THIS HAD AT THE LAST MEETING, FULL MEETING, WHAT IS THE RATIONALE -- THERE'S TWO SETS OF RESEARCH. THERE'S RESEARCH FOR THE EXPEDITED REVIEW LIST, THIS IS NOT THE NEW REGULATION. SO IF THIS WERE PUBLISHED TOMORROW, THIS WOULD PERTAIN TO THINGS EYE PROVED THINGS APPROVED UNDER BOTH, AND SOME REMAIN UNDER THE OLD REGULATIONS FOR A LONG TIME. SO IF YOU LOOK AT JUST THINGS APPROVED UNDER THE NEW RULE, THERE'S ALREADY AN OUT IF THE BOARD FEELS THAT THEY SHOULD GO THROUGH CONTINUING REVIEW. WHAT'S THE JUSTIFICATION FOR THINGS THAT MEET THESE CRITERIA ACTUALLY COMING BACK FOR EXPEDITED REVIEW AS A DEFAULT, AS OPPOSED TO FLIPPING IT? >> JONATHAN'S MEMORY MIGHT BE BETTER THAN MINE. >> FOR B WE STRUGGLED WITH THIS ON THE SUBCOMMITTEE, BECAUSE AT THE POINT A PARTICIPANT IS ENROLLED, YOU IMMEDIATELY -- IF IT'S BEEN MORE THAN 12 MONTHS SINCE YOUR LAST REVIEW, YOU'RE IMMEDIATELY OUT OF COMPLIANCE AND HOW DO YOU GET IT, SO THAT ONE HAS TO KEEP COMING BACK. I THINK, A, YOU COULD MAKE A COGENT ARGUMENT THAT ALL INTERVENTIONS ARE DONE YOU AND DON'T NEED LONG TERM FOLLOW-UP THAT YOU KNEELED CONTINUING LONG TERM REVIEW. >> AND A NEEDS TO BE THERE FOR STUDIES APPROVED UNDER THE CURRENT RULE ANYWAY. >> SO THERE IS THE CURRENT RULE PROBLEM. I THINK PART OF IT WAS AK NOMGING THAT THERE WILL BE STUDIES FOR SOME TIME THAT MAY CONTINUE TO FALL UNDER THE OLD RULE. >> AND OF COURSE BECAUSE THIS HAS TO SERVE MAYBE FOR BOTH RULES, THAT LAST SENTENCE MAY NEED TO BE QUALIFIED FOR STUDIES BECAUSE IT WOULDN'T APPLY TO STUDIES APPROVED UNDER THE CURRENT RULE AND MAINTAINED UNDER THE CURRENT RULE, THERE IS NO EXEMPTION 105F1. >> YEAH. PEOPLE LOOK READY FOR LUNCH. OH, NOT JIM. >> JIM. >> JUST A SMALL POINT. 1 THROUGH 9 AND 10 NEED TO BE CHANGED EVERYWHERE, TO 1 THROUGH 13 AND 14. >> THANK YOU. I REALIZED THAT AS SOON AS I PULLED IT UP THIS MORNING. >> SO ANY LAST COMMENTS OR QUESTIONS BEFORE WE GO TO LUNCH? AND IT WILL BE ON YOU IF YOU ASK IT. ANY. SO LET'S BREAK FOR LUNCH. DAVID, THANK YOU. I THINK WE MADE ACTUALLY A LOT OF PROGRESS ON THAT. I FEEL MUCH -- I KNOW WE CREATED A LOT OF WORK FOR YOU AND THE SUBCOMMITTEE, BUT IT FEELS LIKE WE'VE ACTUALLY HAD SPECIFIC ENOUGH SUGGESTIONS AS OPPOSED TO JUST THINGS TO THINK ABOUT THAT WE MAY BE CLOSE. >> I THINK SO. I'M HAPPY TO -- DEPENDING ON HOW THE AGENDA SHAKES OUT TOMORROW, I'M HAPPY TO TRY TO GET IT READY TO BRING BACK. >> AFTER LUNCH WE JUST HAVE THE LIGHT TOPIC OF BROAD CONSENT, SO -- NO, SO LET'S TRY, IF WE CAN, TO COME BACK HERE BY 1:30 SO WE CAN START ON TIME. WE ONLY LOST 10 MINUTES BY THAT. IF WE DON'T MAKE IT, WE CAN DELAY A LITTLE BIT. THANK YOU. >> WHILE PEOPLE ARE TAKING THEIR SEATS AT THE INTERSECTION OF THE CLOSURE OF THE MINIMAL RISK CATEGORIES AND OPENING DISCUSSION ON CONSENT I WOULD LIKE TO NOTE FOR THOSE WHO HAVE NOT SEEN IT THAT YESTERDAY THE FDA RELEASED GUIDANCE HARMONIZING THEIR REQUIREMENTS FOR WAIVER ALTERATION OF CONSENT WITH THOSE OF OHRP, THAT WILL BE VERY USEFUL TO IRBs. THANK YOU. IF YOU HAVEN'T SEEN IT, IT'S AVAILABLE. SO, WE'RE GOING TO GO RIGHT INTO OUR AFTER-LUNCH TOPIC, BROAD CONSENT. MARK BARNES. >> THANK YOU. THANK YOU, STEPHEN, VERY MUCH. ONE THING I'M NOT SURE THAT I MISSED THE START OF TODAY, BUT I DID WANT TO SAY THAT I REALLY WISH THAT CHRISTINA HEIDI WERE HERE, BECAUSE SHE WOULD BE ABLE TO HELP US THROUGH THIS AND SO I DON'T KNOW IF YOU WANTED TO SAY SOMETHING, STEPHEN. >> I THINK EVERYBODY KNOWS THAT CHRISTINA PASSED AWAY, I THINK, WITHIN THE LAST MONTH. I THINK IT WAS A SHOCK TO SACHRP, OBVIOUSLY SHE WAS QUITE PRIVATE. AND I GUESS I DIDN'T KNOW HER WELL. I WOULD INVITE IF ANYONE WANTS TO SAY ANYTHING MORE PERSONAL, I WOULD INVITE THAT. WE HAVE A COUPLE OF MINUTES. OR WE CAN PERHAPS SAVE THAT TO THE END. >> I'LL SAY, IF I MAY, I HAD KNOWN AND WORKED WITH HER FOR, I DON'T KNOW, I'D SAY FROM THE BEGINNING REALLY OF THE -- OF HER TIME AT OCR. SHE WAS EXTREMELY HELPFUL TO THE COMMITTEE IN IMPLEMENTING MANY RECOMMENDATIONES WE HAD MADE TO EASE AND FACILITATE, TO EASE AND FACILITATE RESEARCH IN LIGHT OF THE ORIGINAL HIPAA PRIVACY REQUIREMENTS, MANY OF WHICH OR SOME OF WHICH WERE NOT EXACTLY DESIGNED TO BE COORDINATED WITH A COMMON RULE AND THE WAY WE DO HUMAN SUBJECTS RESEARCH, PRE-HIPAA. AND CHRISTINA WAS ALWAYS A WONDERFUL COLLEAGUE TO ALL OF US. SHE WAS A WONDERFUL FRIEND TO THIS COMMITTEE, AND I JUST WANTED TO RECOGNIZE THE FACT THAT WE WILL MISS HER GOING FORWARD. >> THANK YOU. >> OKAY. THE-- SO THIS IS WHAT WE'VE DONE SINCE YOU GUYS MET LAST TIME. YOU REMEMBER THAT AT YOUR LAST MEETING, AND THIS IS THE FIRST TIME THAT I'VE BEEN IN THE SAME ROOM WITH SOME OF THE NEW MEMBERS, SO THANK YOU FOR BEARING WITH US IN REGARD TO THIS TOPIC AND OTHER TOPICS. I MISSED MY PLANE LAST TIME, THE PLANE DID NOT COME TO D.C. I HAD DONE THIS BY AUDIO. WE HAD GONE THROUGH A POWERPOINT PRESENTATION THAT I HAD DONE. I'VE TAKEN THE SAME PRESENATION AND CHANGED IT TO REFLECT SOME CHANGES IN OUR DISCUSSIONS WITHIN THE SUBCOMMITTEE ON HARMONIZATION AND SAS, OUR JOINT MEMBERSHIP. WE'VE HAD MULTIPLE CALLS, E-MAILS, I WOULD SAY THAT THE -- THERE ARE TWO DOCUMENTS, ONE IS A GUIDANCE DOCUMENT FOR BROAD CONSENT WHICH I THINK WE'LL TACKLE FIRST. THE SECOND IS TEMPLATE BROAD CONSENT. WE'VE BEEN THROUGH LITERALLY 50 VERSIONS OF THE BROAD CONSENT TEMPLATE, WE'VE BEEN THROUGH FEWER VERSIONS OF GUIDANCE, BUT THROUGH MANY VERSIONS OF THE TEMPLATE BROAD CONSENT. WHAT WE'LL DO, IF THIS IS ALL RIGHT WITH THE COMMITTEE, I WILL FIRST GO BRIEF WILL YOU THROUGH THE SLIDES YOU HAD ALREADY SEEN JUST TO TEE US UP TO THE ISSUES WE'RE GOING TO TALK ABOUT AND THEN WE'LL TALK ABOUT THE GUIDANCE DOCUMENT. AFTER THAT WE'LL TALK ABOUT THE TEMPLATE, BROAD CONSENT. THAT'S WHAT I WOULD PROPOSE TO DO. I WOULD SAY THIS THOUGH BEFORE WE DIVE INTO IT. YOU SHOULD SAY WHAT YOU THINK, OBVIOUSLY. YOU WILL, I'M SURE. THESE ARE NEITHER THE PENTATUCH NOR THE GOSPELS. THIS IS PAUL'S LETTER TO THE CORINTHIANS, IT'S COMMENTARY, NOT THE TEXT. SPECIFICALLY WHEN YOU GET TO THE TEMPLATE CONSENT REMEMBER THIS IS BUT ONE PATH TO THE LIGHT, NOT THE ONLY TEMPLATE THAT CAN BE USED. IT IS A TEMPLATE THAT IS DESIGNED TO COORDINATE WITH HIPAA AS WELL AS THE REQUIREMENTS OF BROAD CONSENT IN THE FINAL COMMENT ONRULE. SO PLEASE, YOU KNOW, THIS IS NOT THE ONLY TERRITORY TO BE FOUGHT OVER, PLEASE. KEEP THAT IN MIND. ODDLY WE SPENT MOST OF OUR TIME IN COMMITTEE TALKING ABOUT THE TEMPLATE BROAD CONSENT, BUT I THINK IN THE END PROBABLY THE GUIDANCE IS ACTUALLY MORE IMPORTANT THAN THE TEMPLATE BECAUSE THE GUIDANCE SETS THE -- THE TEMPLATE SEASON ONE EXAMPLE, WHEREAS THE GUIDANCE IS SOMEWHAT OF GREATER -- PERHAPS OF GREATER VALUE GOING FORWARD. SO WITH THAT, LET ME JUST REMIND YOU OF SOME OF THE BACKGROUND HERE. THERE ARE TWO NEW EXEMPTIONS AVAILABLE UNDER THE FINAL VERSION OF THE COMMON RULE. THAT IS ONE IS YOU CAN STORE AND MAINTAIN IDENTIFIABLE PRIVATE INFORMATION OR IDENTIFIABLE BIOSPECIMENS FOR POTENTIAL SECONDARY USE, THE ABILITY TO HAVE AN IDENTIFIED BIOREPOSITORY, IDENTIFIED DATA& BANK. THE SECOND WOULD BE YOU COULD USE THOSE FOR RESEARCH. THOSE ARE TWO NEW EXEMPTIONS, BOTH DEPEND ON AVAILABILITY AND EXECUTION OF BROAD CONSENT. WE ON OUR SUBCOMMITTEES HAVE BEEN CALLING THIS THE NEW BROAD CONSENT BECAUSE IT IS A STATUTORY OR REGULATORY BROAD CONSENT, AS OPPOSED TO THE OLD BROAD CONSENT WITH A LITTLE B AND A LITTLE C, SIMPLY THE BROADLY WORDED PROVISIONS TO ALLOW FUTURE USE OF IDENTIFIABLE BIOSPECIMENS AND IDENTIFIABLE DATA THAT WE'VE OFTEN SEEN ATTACHED, FOR EXAMPLE, TO NIH-FUNDED ONCOLOGY STUDIES. SO WE CALL -- FOR THESE PURPOSES, WHEN I TALK ABOUT BROAD CONSENT, I'M PROBABLY TALKING ABOUT THE -- WHAT WE'VE CALLED THE NBC OR NEW BROAD CONSENT, AS OPPOSED TO OBC, OLD BROAD CONSENT, WHICH IS THE NON-REGULATORY BROADLY EXPRESSED FUTURE PURPOSES OF THE INFORMED CONSENT FORM. THE NEW FINAL RULE ALLOWS US TO USE A BROAD CONSENT, BUT A BROAD CONSENT HAS TO BE USED, HAS TO BE EXECUTED BY THE INDIVIDUALS IN ORDER FOR ANYONE TO TAKE ADVANTAGE OF THESE -- A RESEARCHER TO TAKE ADVANTAGE OF ONE OF THESE OR BOTH OF THESE TWO EXEMPTION. IN A BROAD CONSENT IS EXECUTED, BOTH OF THESE EXEMPTIONS WOULD BE ACCESSED OR TAKEN ADVANTAGE OF BY THE RESEARCHER WHO HAS OR THE RESEARCH INSTITUTION THAT HAS THE BROAD CONSENT. IF THE BROAD CONSENT, THE NBC, IS EXECUTED, THEN ANY SUBSEQUENT STORAGE MAINTENANCE AND SECONDARY RESEARCH USED OF THE IDENTIFIABLE BIOSPECIMENS AND IDENTIFIABLE DATA THAT ARE CONSISTENT WITH THE PURPOSES EXPRESSED IN THE BROAD CONSENT WOULD NOT REQUIRE ANY ADDITIONAL CONSENT, WOULD ALSO IN THE REQUIRE FULL IRB APPROVAL, ONLY A LIMITED. WE'LL TALK ABOUT THAT THAT LIMITED IRB REVIEW OUGHT TO LOOK LIKE AND WHAT OUGHT TO BE REQUIRED FOR IT. THERE ARE MULTIPLE MANDATED ELEMENTS FOR THE NBC, NEW BROAD CONSENT, AND ABOUT 10 OR 11 OF THEM QUITE SPECIFIC IN TERMS OF WHAT THE BROAD CONSENT MUST ACTUALLY SAY TO BE EFFECTIVE. THE TEMPLATE YOU'LL SEE A LITTLE LATER, I'M SURE YOU'VE LOOKED AT BEFORE AND THAT WE'VE DISCUSSED BEFORE, MAINTAINS OR CONTAINS ALL OF THOSE REQUIRED ELEMENTS, ACCORDING TO THE NEW FINAL RULE REQUIREMENTS. IN THE FINAL RULE COMMENTARY, HHS, REMEMBER, SAID AT A LATER TIME HHS SECRETARY EXPECTS TO DEVELOP GUIDANCE INCLUDING BROAD CONSENT TEMPLATES. LATER IS NOW. AND THAT'S WHAT WE'RE TRYING TO DO AS A RECOMMENDATION TO OHRP AND ULTIMATELY TO THE HHS SECRETARY, BOTH IN REGARD TO THE GUIDANCE AND ALSO IN REGARD TO THE TEMPLATE BROAD CONSENT. TO CONDUCT SECONDARY RESEARCH ON IDENTIFIABLE BIOSPECIMENS OR DATA ONE MUST HAVE STUDY-SPECIFIC CONSENT AND FULL OR EXPEDITED IRB REVIEW, BROAD CONSENT, AND LIMITED IRB REVIEW, THAT IS THE NEW BROAD CONSENT, AND LIMITED IRB REVIEW, WITH ACCESS TO THE TWO EXEMPTIONS. ONE COULD HAVE WAIVER OF CONSENT AND EXPEDITED REVIEW. EXEMPTION ALLOWS ONE TO LOOK AT IDENTIFIABLE DATA, REPORT IT IN A WAY THAT'S NOT IDENTIFIABLE, THAT'S AN AVAILABLE EXEMPTION. OR ONE COULD HAVE FULL DEIDENTIFICATION TO REMOVE RESEARCH ACTIVITY FROM THE BEGINNING FROM THE SCOPE OF THE COMMON RULE WHICH WOULD NOT REQUIRE CONSENT OR IRB REVIEW AND WOULD ALSO BY THE WAY TAKE IT OUT OF THE PARALLEL REGULATORY STRUCTURE OF HIPAA IF THE DATA ARE TRULY DE-IDENTIFIED TO THOSE DEFICIENCY ALL THE STANDARDS AS OPPOSED TO ANONYMIZATION OR LESSER STANDARD UNDER THE COMMON RULE. THE FINAL RULE CHANGED CERTAIN ELEMENTS OF BROAD CONSENT THAT WERE PROPOSED ORIGINALLY IN THE NPRM TO REQUIRE MORE SPECIFIC INFORMATION ABOUT SECONDARY RESEARCH, THE REQUIREMENT HERE& FOR BROAD CONSENT IS THE DESCRIPTION OF FUTURE USE MUST CONTAIN SUFFICIENT INFORMATION TO ALLOW A REASONABLE PERSON TO EXPECT THAT THE BROAD CONSENT WOULD PERMIT TYPES OF RESEARCH CONDUCTED. REMEMBER THAT IF -- THAT THE BROAD CONSENT IS SOMETHING DIFFERENT THAN A REGULAR CONSENT. IT'S VERY STRANGE BECAUSE I MEAN IN A JURIS AND REGULATORY CONSENT, BROAD CONSENT IS NOT CONSENT TO A STUDY. THERE'S NO PROTOCOL BY WHICH THE IRB ADOPTS POSSIBILITIES AND SAYS, OH, YOU CAN GO GET A BROAD CONSENT STUDY. INSTEAD A BROAD CONSENT IS KIND OF ITS OWN STUDY FROM THE BEGINNING. IT'S HAVING THE BROAD CONSENT BY THE SUBJECT, ALLOWS THE RESEARCHER OR RESEARCH INSTITUTION BASICALLY KIND OF TO OPT OUT BASICALLY FROM THE ENTIRE IRB PROCESS EXCEPT FOR LIMITED REVIEW REQUIRED WHEN ONE OF THE EXEMPTIONS IS TRIGGERED. BUT THE FORMATION OF ALL OF THE DATA BANK AND BIOSPECIMEN REPOSITORY UNDER THE BROAD CONSENT DOES NOT REQUIRE AN ACTUAL BIOBANKING OR DATA BANKING PROTOCOL THAT IS INITIALLY APPROVED BY THE IRB. THAT'S ONE WAY IT'S DIFFERENT. THE OTHER WAY IT'S DIFFERENT -- BY THE WAY WE HAD TO REMIND OURSELVES THROUGH THE PROCESS BECAUSE WE KEPT THINKING THE BROAD CONSENT WAS ANOTHER INFORMED CONSENT FOR BIOBANKING, BUT IT WASN'T THAT, IN A REGULATORY SENSE IT'S DIFFERENT. ER D I F FERENT. WHAT THE MBC GRANTS WITH ONE HAND, IT TAKES AWAY WITH THE OTHER. IF THE BROAD CONSENT IS PROFFERED TO AN INDIVIDUAL AND THE INDIVIDUAL REFUSES TO CONSENT, THE TERMINOLOGY IS REFUSED TO CONSENT, THAT HAS A CONSEQUENCE OTHER FAILURES TO CONSENT OR OTHER REFUSALS TO CONSENT IN ACTUAL STUDIES DOES NOT HAVE. AND THAT CONSEQUENCE BY THE REGULATION IS THAT IF YOU DECLINE A BROAD CONSENT, IF YOU REFUSE TO CONSENT, TO A BROAD CONSENT, IT MEANS THAT YOUR IDENTIFIABLE DATA AND BIOSPECIMENS ARE TAKEN OUT OF THE POSSIBILITY OF BEING SUBJECT TO A WAIVER OF CONSENT PROCESS GOING FORWARD. THAT'S DIFFERENT THAN A BIOBANKING STUDY UNDER AN OLD BROAD CONSENT IN WHICH ONE MIGHT DECLINE TO ENTER A STUDY WITH BIOBANKING OF YOUR IDENTIFIABLE DATA OR BIOSPECIMENS, CAN YOU DECLINE BUT THAT DOESN'T MEAN ANOTHER RESEARCHER MIGHT SAY I'D LIKE A WAIVER OF CONSENT FOR USE OF YOUR DATA OR BIOSPECIMENS. THIS IS A DIFFERENT ANIMAL. IN FACT, IT'S SORT OF CALLING IT CONSENT IS THE SAME TERMINOLOGY THAT WE USE FOR REGULAR STUDY, BUT IT REALLY IS A DIFFERENT SPECIES. I DON'T KNOW WHETHER IT'S NEANDERTHAL OR HOMO SAPIENS BUT IT'S SOMETHING. BUT IT'S NOT US. SO WE HAVE TO THINK OF IT IN THIS SLIGHTLY DIFFERENT WAY, AND THAT'S BEEN CHALLENGING I THINK FOR THE PROCESS FOR ALL OF US. WHAT YOU CAN DO, HOWEVER, AND THIS IS IN THE REGULATION, AND IT'S IMPORTANT FOR US BECAUSE ULTIMATELY I THINK AS A CONSEQUENCE OF THIS WE'RE GOING TO NEED TO GO BACK AND RELOOK AT FAQs THIS COMMITTEE ADOPTED YEARS AGO IN REGARD TO THIS PARTICULAR ISSUE I'M ABOUT TO TALK ABOUT. THIS REGULATION SAYS THAT IF SOMEONE DECLINES TO GIVE THE BROAD CONSENT, ONE CAN NEVERTHELESS AS A RESEARCHER OR RESEARCH INSTITUTION DEIDENTIFY THE DATA AND DEIDENTIFY THE BIOSPECIMENS AND GO AHEAD AND USE THEM IN A DE-IDENTIFIED WAY. SO THE BROAD CONSENT IS REFUSAL TO ALLOW THE BROAD CONSENT IS A REFUSAL TO ALLOW THE FUTURE USE OF THE DEIDENTIFIABLE DATA AND IDENTIFIABLE BIOSPECIMENS, NOT REFUSAL TO USE DE-IDENTIFIED DATA, DIFFERENT THAN ONE OF THE ANSWERS WE GAVE IN THE FAQ WHICH WAS PASSED SIX OR SEVEN YEARS AGO. I'M LOOKING AT JULIA. THAT'S MY RECOLLECTION. WE FOUGHT OVER THIS PARTICULAR ISSUE AT THE TIME. MANY OF US THOUGHT THIS IS THE LOGISTICS ARE DAUNTING. THERE ARE TWO REAL USES FOR BROAD CONSENT. I MEAN FOR THE NBC. ONE COULD TRY TO IMELEMENT THIS FOR A WHOLE GROUP OF PATIENTS IN A REGULAR WAY AT MEDICAL INSTITUTION OR IN A SOCIAL SERVICE CONTEXT. ONE COULD DO THAT. BUT IF ONE DOES THAT THINKING THAT WOULD GIVE A CARTE BLANCHE TO FUTURE USE, THAT'S FINE BUT YOU HAVE TO KEEP A REGISTRY ALSO OF THOSE WHO REFUSED TO CONSENT, YOU HAVE TO TAKE THOSE PEOPLE OUT OF THE PROCESS. THAT'S ONE USE. YOU CAN DO IT BUT THERE ARE REAL LOGISTICAL PROBLEMS, ESPECIALLY IF YOU HAVE A DECENTRALIZED MEDICAL SYSTEM OR SOCIAL SERVICE SYSTEM, WHATEVER IT IS, IT MEANS THAT UNLESS THE I.T. SYSTEM IS TRULY SEAMLESS AND YOU CAN TRACK A PATIENT OR CLIENT THROUGH THE ENTIRE PROCESS, AND MAKE SURE THAT THEIR IDENTIFIABLE DATA OR BIOSPECIMENS ARE NEVER USED IN THE FUTURE WHEN THEY HAVE REFUSED TO CONSENT UNLESS YOU CAN DO THAT YOU'RE VIOLATING BROAD CONSENT REQUIREMENTS. THAT'S ONE USE, YOU CAN DO IT IF YOU COULD TRACK. THE OTHER USE PROBABLY AS IT'S DAWNED ON US THROUGH THE PROCESS MUCH MORE LIKELY IS THAT WHEN ONE HAS A STUDY, WHETHER IT IS A SPECIFIC BANKING STUDY, OR WHETHER FOR SOME DEFINED SET OF PURPOSES, FOR EXAMPLE, TO GET ALL OF THE -- TO GET 500 PEOPLE WITH MEDICAL CONDITION X, WITH DIAGNOSIS CODES X, Y AND Z, IF YOU HAVE THAT, AND YOU ONLY WANT TO DEAL WITH THOSE PATIENTS GOING FORWARD, THOSE CLIENTS GOING FORWARD, THOSE SUBJECTS, YOU COULD OFFER BROAD CONSENT TO THEM AS PART OF OVERALL BIOBANKING STUDY. THAT'S ONE POSSIBLE USE. THEN YOU DON'T CARE ABOUT THE PEOPLE WHO OPTED OUT, ONLY THE PEOPLE THAT OPTED IN, THAT'S YOUR SUBJECT POPULATION. THE OTHER POSSIBILITY IS IN A PRIMARY STUDY, WHETHER IT'S SOCIAL AND BEHAVIORAL OR WHETHER IT'S MEDICAL, CLINICAL, ONE COULD OFFER THE BROAD CONSENT, EITHER AS A PACKAGE DEAL WITH CONSENT INTO THE STUDY OR ONE COULD OFFER IT IN THE OLD NCI TEMPLATE AS A CHECK BOX AT THE END OR SEPARATE SIGNATURE PERHAPS AT THE END OF THE DOCUMENT, SEPARATE CONSENT, BUT ONE WOULD TARGET THOSE PEOPLE WHO ENROLLED IN A PRIMARY STUDY TO BE ABLE TO SIGN THE BROAD CONSENT TO ALLOW FUTURE UNSPECIFIED USES, TAKING ACCESS TO THE EXEMPTIONS. SO THOSE ARE MUCH MORE -- THOSE TWO POSSIBILITIES, RATHER THAN BROAD USE OF THE BROAD CONSENT FOR ALL PATIENTS OR ADMISSIONS, INTO A HOSPITAL OR SOCIAL SERVICE SETTING, ARE PROBABLY IN OUR ESTIMATION MUCH MORE LIKELY. LET ME PAUSE THERE AND SEE IF THERE ARE ANY COMMENTS OR QUESTIONS ABOUT THAT. I WANT TO MAKE SURE EVERYBODY IS SORT OF -- PERHAPS EVERYBODY UNDERSTANDS THAT INTUITIVELY BUT THAT WAS NOT INTUITIVE TO US AT THE BEGINNING OF THIS PROCESS. OKAY. I'LL GO AHEAD. SO HERE ARE THE RECOMMENDATIONS THAT ARE CONTAINED IN THE GUIDANCE DOCUMENT. I'M GOING TO GO THROUGH THESE BRIEFLY. WE TALKED A LOT ABOUT THEM IN THE LAST SESSION WHICH I DID BY -- REMOTELY WITH ALL OF YOU. ONE OF THE PRIOR ISSUES IS WHAT DOES REFUSAL TO CONSENT MEAN AND IT'S IMPORTANT BECAUSE REFUSAL TO CONSENT IS WHAT TAKES THE PERSON'S IDENTIFIABLE DATA AND BIOSPECIMENS OUT OF THE RESEARCH PROCESS ENTIRELY UNTIL THE PERSON IS DEAD, OR FOR HIPAA PURPOSES ACTUALLY UNTIL THE PERSON IS DEAD PLUS 50 YEARS. SO THAT'S A SIGNIFICANTLY DIFFERENT RESULT THAN SIMPLY SAYING I DON'T WANT TO PARTICIPATE IN A PRIMARY STUDY OF ONE KIND OR ANOTHER. WHAT DOES THAT REFUSAL TO CONSENT ACTUALLY MEAN? AND ONE OF THE PROBLEMS, SOME PEOPLE MAY SAY, NO, SOME PEOPLE MAY SAY YES, AND THEN SOME PEOPLE SAY I DON'T WANT TO DEAL WITH THIS RIGHT NOW. GIVEN THE COMPLEXITY OF THE BROAD CONSENT CONCEPT, THERE MAY BE A LOT OF PEOPLE WHO SAY I DON'T WANT TO DEAL WITH THIS. I DON'T UNDERSTAND AND DON'T WANT TO DEAL WIT OR ASK ANY QUESTIONS. SO THAT IS MUCH MORE LIKELY IN THE BROAD INSTITUTIONAL USE OF THE BROAD CONSENT, IF AND WHEN AN INSTITUTION MAY DECIDE TO DO THAT. SO WHAT WE RECOMMENDED AND WHAT'S IN THE GUIDANCE DOCUMENT, JUST TO REMIND YOU, IS THAT HHS INTERPRET REFUSAL TO CONSENT TO INCLUDE EXPRESSED DECLINATION TO GIVE BROAD CONSENT, WE ALSO SAY THAT SILENCE OR FAILURE TO RESPOND OR FAILEDDURE TO COMMUNICATE AND UNAMBIGUOUS DECLINATION WOULD NOT CONSTITUTION REFUSAL TO CONSENT. NOT CONSTITUTE BROAD CONSENT OR REFUSAL TO CONSENT WITH CONSEQUENCE THE INDIVIDUAL'S IDENTIFIABLE DATA AND BIOSPECIMENS WOULD BE KEPT OUT OF THE PROCESS UNTIL THE END OF THE PERSON'S LIFE. THAT'S ONE OF THE PRIMARY RECOMMENDATIONS. I'M GOING TO SKIP OVER RATIONALES, WE TALKED ABOUT THAT FOR QUITE SOME TIME. THE SECOND BIG ISSUE EMBEDDED IN THE DRAFT GUIDANCE DOCUMENT, THOSE PEOPLE WHO WOULD BE BOUND BY A TRUE REFUSAL TO CONSENT. THE QUESTION HERE IS, IF YOU HAVE WITHIN ONE LARGE MEDICAL CENTER OR ONE LARGE SOCIAL SERVICE SETTING, IF YOU HAVE ONE OFFICE AND ONE SET OF RESEARCHERS THAT OFFERS A BROAD CONSENT, AND THE PERSON REFUSES, THEN WHAT DOES THAT MEAN ABOUT THE ABILITY OF OTHER RESEARCHERS, OTHER DEPARTMENTS, OTHER DIVISIONS, OTHER AFFILIATED INSTITUTIONS OR INSTITUTION THAT'S COMPLETELY UNAFFILIATED AND ITS RESEARCHERS, DOES THAT MEAN -- IS THE CONSEQUENCE THEY HAVE TO TAKE DEIDENTIFIABLE SPECIMENS AND DATA OUT OF THE RESEARCH PROCESS FOREVERMORE? IT'S AN ODD SITUATION BECAUSE THE -- WELL, I WILL -- WE CAN TALK ABOUT DETAILS OF IT, BUT IT'S AN ODD SITUATION. SO WHAT WE DECIDED, GIVEN THE VAGARIES OF THIS AND COMPLEXITIES OF THIS, IS THAT REMEMBER THAT IN THE BROAD CONSENT, THAT THE NEW BROAD CONSENT THAT'S OFFERED, ONE HAS TO SAY THE PARTIES OR THE CATEGORIES OF PARTIES WHO WOULD BE ABLE TO TAKE ADVANTAGE OF THE BROAD CONSENT. SO WE THOUGHT THAT THE EASIEST WAY, IT'S NOT PERFECT BUT THE EASIEST WAY TO IMPLEMENT THIS WOULD BE THAT THOSE PARTIES THAT ARE LISTED IN THE BROAD CONSENT AS PERMISSIBLE RECIPIENTS OF THE BROAD CONSENT WHICH WOULD THEN TRIGGER ACCESS TO USE OF THE TWO NEW EXEMPTIONS, THOSE WOULD BE THE PARTIES THAT WOULD BE BOUND BY THE REFUSAL OF THE PERSON TO GRANT THE BROAD CONSENT. SO IN OTHER WORDS, IF -- SIMPLE EXAMPLE. IF A BROAD CONSENT IS OFFERED AT LENNOX HILL HOSPITAL AND THE PERSON REFUSES, AND THE PERSON A YEAR LATER IS ADMITTED TO MEMORIAL SLOAN-KETTERING THAT DOES NOT STOP SLOAN-KETTERING FROM OFFERING ITS OWN BROAD CONSENT NOR DOES THE PRIOR REFUSAL BIND SLOAN-KETTERING IN THE FUTURE. ANOTHER POSSIBILITY WITHIN ONE INSTITUTION MAY BE -- WELL, NOT PATHOLOGISTS BECAUSE THEY DON'T SEE PATIENTS UNLESS THEY ARE DEAD, BUT IN OTHER SITUATIONS, LET'S SAYS A SURGEON DEALS WITH A PATIENT AND SURGERY DEPARTMENT OFFERS BROAD CONSENT. AND THE BROAD CONSENT SAYS THIS BROAD CONSENT IS IN FAVOR OF THE SURGERY DEPARTMENT, THAT WOULD NOT BIND ACCORDING TO THIS INTERPRETATION, WOULD NOT BIND ANOTHER ENTIRELY DIFFERENT DEPARTMENT OF THE HOSPITAL FROM OFFERING A BROAD CONSENT, NOR WOULD IT BIND THEM BY THE -- NOR WOULD IT BIND THEM NOT TO BE ABLE TO ACCESS THE PERSON'S IDENTIFIABLE DATA FOR RESEARCH PURPOSES THROUGH WAIVER OF THE PARTY THAT WAS THE INTENDED BENEFICIARY OF THE -- AND NAMED BENEFICIARY OF THE PROFFERED BROAD -- THE ORIGINAL PROFFERED BROAD CONSENT. IF YOU DON'T HAVE THIS INTERPRETATION, IT'S NOT PERFECT, BUT IF YOU DON'T HAVE THIS INTERPRETATION, IT'S REALLY -- IT'S NOT FEASIBLE EVEN TO OFFER A BROAD CONSENT AT ALL, THOUSAND WOULD SLOAN-KETTERING KNOW THE PERSON REFUSED A BROAD CONSENT AT MEMORIAL HOSPITAL. HOW WOULD THE INFECTIOUS DISEASE DEPARTMENT KNOW A PERSON REFUSED BROAD CONSENT FROM THE SURGERY DEPARTMENT? IT'S NOT WORKABLE OTHERWISE. IT'S NOT PERFECT, BUT IT'S NOT WORKABLE OTHERWISE. SO ONE HAS TO THINK ABOUT THE ALTERNATIVES WHICH ARE -- THIS IS THE LEAST BAD ALTERNATIVE. IN REGARD TO DESCRIBING SCOPE OF FUTURE USES REMEMBER THAT IF ONE IS GOING TO DO WHOLE GENOME SEQUENCING IT'S REQUIRED BY THE TERM OF THE BROAD CONSENT, THE WHOLE GENOME SEQUENCING BE NAMED AS AN ACTIVITY TO WHICH THE IDENTIFIABLE BIOSPECIMEN WOULD BE SUBJECTED IN THE BROAD CONSENT IF YOU WANT TO DO THAT IN THE FUTURE. THAT WE KNOW WE HAVE TO DO. IN OTHER SITUATIONS REMEMBER WE HAVE STATE LAWS THAT REQUIRE SPECIFIC CONSENT FOR THINGS LIKE GENETIC TESTING WHICH MAY BE MUCH LESS AGGRESSIVE THAN WHOLE GENOME SEQUENCING THAT REQUIRES SPECIAL CONSENT FOR USE AND TRANSMISSION OF HYGIENE INFORMATION, INFORMATION ABOUT DEVELOPMENTAL DISABILITY AND MENTAL RETARDATION, TB, STDs, ABOUT INDUCED VOLUNTARY INDUCED TERMINATION OF PREGNANCY. THERE ARE STATE LAWS IN DIFFERENT STATES REQUIRE THESE THINGS BE MENTIONED EXPLICITLY IN SOME KIND OF CONSENT IN ORDER FOR RESEARCHERS TO BE ABLE TO USE THAT INFORMATION FOR THOSE PURPOSES GOING DOWN THE LINE. SO IN THE TEMPLATE BROAD CONSENT YOU WILL SEE THAT WE HAVE ACTUALLY CALLED OUT A NUMBER OF CATEGORIES, TRYING TO -- BY THE WAY SUBSTANCE ABUSE TREATMENT UNDER THE FEDERAL AND ALCOHOLISM TREATMENT UNDER THE FEDERAL DRUG AND ALCOHOLISM TREATMENT REGULATIONS, WE CALLED OUT A NUMBER OF THINGS AND EMBEDDED THEM IN THE BROAD CONSENT NOT BECAUSE THEY HAVE TO BE USED. ONE CAN EDIT THEM OUT OF A BROAD CONSENT BUT YOU HAVE TO DO THE STUFF ACCORDING TO STATE OR FEDERAL LAW OR FOR WHOLE GENOME SEQUENCING COULDN'T DO IT UNDER THE BROAD CONSENT, UNLESS THESE THINGS ARE NAMED. SO THAT'S WHAT ALL THAT IS. SO THE QUESTION IS, AND WHAT WE NEVERTHELESS THE COMMITTEE WAS CAREFUL TO SAY, ONE DOES NOT NEED TO NAME EVERY CATEGORY OF RESEARCH ACTIVITY ALTHOUGH SOME CATEGORIES MUST BE NAMED TO MEET OTHER REGULATORY REQUIREMENTS. THAT'S THE BASIC THRUST OF THE RECOMMENDATION. ON THE INTERPRETATION OF WHAT IT WOULD MEAN IF SOMEONE GRANTS BROAD CONSENT AND WITHDRAWS IT AND ONE MUST OFFER THE INFORMATION ABOUT HOW TO WITHDRAW BROAD CONSENT, THE DRAFT GUIDANCE SAYS IF AN INDIVIDUAL GIVES BROAD CONSENT, BUT LATER WITHDRAWS IT, INVESTIGATORS MAY CONTINUE TO USE THE PERSON'S COLLECTED AND STORED IDENTIFIABLE DATA AND BIOSPECIMENS AS LONG AS THEY WERE SUBSEQUENTLY STRIPPED OF IDENTIFIERS, ALLOW IN THE BROAD CONSENT RULE. WE SAY BROAD CONSENT FORMS SHOULD DESCRIBE CONSEQUENCES OF WITHDRAWAL OF BROAD CONSENT AND SAY THE WITHDRAWAL WOULD NOT PREVENT COMPLETION OF USE OF THAT PERSON'S IDENTIFIABLE DATA AND SPECIMENS IN A STUDY ALREADY COMMENCES AND WOULDN'T PERMIT CONTINUED, SO THE INFORMATION COULD BE SUBJECTED TO INQUIRY IN CASE THERE WERE QUESTIONS WILL DATA INTEGRITY OR ABUSE OF HUMAN SUBJECTS. THERE WOULD BE RETENTION OF DATA, BUT THE CONSEQUENCES OF WITHDRAWAL OUGHT TO BE SPELLED OUT IN THE ACTUAL TEMPLATE BROAD CONSENT R IN THE BROAD CONSENT, THIS IS WHAT THE SUBCOMMITTEE HAS RECOMMENDED. IN REGARD TO CONTENT OF LIMITED IRB REVIEW, REMEMBER THAT THE EXEMPTION IS AVAILABLE WHEN YOU HAVE A BROAD CONSENT, WHEN YOU HAVE A NEW BROAD CONSENT THAT MEETS THE REQUIREMENTS, BUT THERE STILL MUST BE LIMITED IRB REVIEW. SO THE QUESTION IS WHAT IS AN IRB SUPPOSED TO REVIEW? THE FINAL RULE DOES NOT DESCRIBE WITH GREAT PARTICULARITY DEGREE OF DILIGENCE REQUIRED BY AN IRB. WE ARE RECOMMENDING AND THE GUIDANCE DOCUMENT A LIMITED IRB REVIEW BE DONE TO ASSESS WHETHER BROAD CONSENT IS OBTAINED IN ACCORDANCE WITH THE REQUIREMENTS THAT IT WOULD LOOK AT THE -- THE IRB IN THE LIMITED REVIEW WOULD LOOK AT BROAD CONSENT FORM, NOT EVERY SINGLE ONE OF EVERY SUBJECT, BUT THE BROAD CONSENT FORM THAT WAS USED TO GAIN THE BROAD CONSENT, ON THE BASIS OF WHICH THE EXEMPTION IS BEING -- USE OF EXEMPTION IS BEING SOUGHT TO ENSURE THE FORM MEETS THE APPLICABLE REQUIREMENTS AND CONTAINS THE REQUISITE ELEMENTS, INCLUDING BY THE WAY THE ELEMENTS OF -- REQUIRED BY STATE OR FEDERAL LAW IN REGARD TO DRUG AND ALCOHOL ABUSE TREATMENT INFORMATION. WE SAY THAT THE -- TO SATISFY THE REQUIREMENT IRB SHOULD ENSURE BROAD CONSENT IS DOCUMENTED AND SHOULD SEEK FROM INVESTIGATORS A CERTIFICATION SEEKING TO PROFFER BROAD CONSENT TO GET ACCESS TO EXEMPTION, REPRESENT TO THE IRB THEY HAVE OBTAINED WERE OR THE SUBJECT HAS GIVEN BROAD CONSENT, BROAD CONSENT IS DOCUMENTED AND AVAILABLE AND WILL REMAIN AVAILABLE TO THE IRB FOR INTEGRITY PURPOSES, AND THE INVESTIGATOR WILL PROVIDE SUMMARY OF PROCESS USED TO SEEK BROAD CONSENT, INCLUDING WHETHER THE BROAD CONSENT HAS BEEN SOUGHT AND OBTAINED IN PERSON, THROUGH MAIL, E-MAIL, IN PERSON, ET CETERA. THIS WOULD BE THE SCOPE OF DILIGENCE FOR THE LIMITED REVIEW REQUIREMENT OF THE IRB. THERE IS ALSO A REQUIREMENT IN THE -- AS PART OF THE NEW BROAD CONSENT THAT IF THE BROAD CONSENT PROMISES TO RETURN RESEARCH RESULTS, THEN THE ACCESS TO THE EXEMPTION WOULD NOT BE AVAILABLE. THE THEORY THERE IS IF THERE'S GOING TO BE AN ACTUAL INTERACTION, OR A HIGHER RISK OF INTERACTION IN THE FUTURE BETWEEN THE RESEARCHER AND THE INDIVIDUAL SUBJECT, WHO ASSIGNED BROAD CONSENT, THAT IS AN INTERACTION WHICH ELEVATES THIS OVER THE KIND OF PASSIVE USE OF IDENTIFIABLE BIOSPECIMENS AND IDENTIFIABLE INFORMATION, AND OUGHT TO PREVENT THE RESEARCHER FROM BEING ABLE TO TAKE ADVANTAGE OF THE BROAD CONSENT. INSTEAD THE RESEARCHER WOULD HAVE TO GO THROUGH WHATEVER OTHER MECHANISM HE OR SHE HAS TO DO UNDER EXISTING RESEARCH REGULATIONS IN ORDER TO CONDUCT THE STUDY WHICH WOULD INCLUDE RETURN OF RESULTS. THE INTERPRETATION THAT'S IMPORTANT HERE THOUGH IS THAT IN SOME CASES THERE MAY BE INCIDENTAL FINDINGS THAT ARE NOT INTENDED FINDINGS. FOR EXAMPLE, SCANS, THE REVIEW OF IMAGES. AND IF THAT HAPPENS, WE THOUGHT THAT THE RETURN OF INCIDENTAL FINDINGS THAT WAS NOT INTENDED AS PART OF THE ORIGINAL RESEARCH DESIGN, THE FACT THAT INCIDENTAL -- AN INCIDENTAL FINDING OR FINDINGS WOULD BE RETURNED WOULD NOT LEAD TO THE LACK OF ABILITY OF THE RESEARCHER TO GET AN EXEMPTION OR MAINTAIN AN EXEMPTION UNDER THIS REQUIREMENT. ALSO, THE RETURN OF GENERAL OR AGGREGATE RESULTS WOULD ALSO NOT -- NOT SPECIFIC TO THE INDIVIDUAL WOULD ALSO NOT PULL THE STUDY OUT OF THE ABILITY TO TAKE ADVANTAGE OF THE EXEMPTION. THEN IN RECORD TO OBC, OLD BROAD CONSENT, THE GUIDANCE SAYS THE EFFECTIVENESS OF OLD BROAD CONSENT CONSENT IS NOT DILUTED OR HARMED BID A Y ADVENT OF NEW BROAD CONSENT. THE NEW CONSENT IS ANOTHER OPTION FOR RESEARCHERS AND INSTITUTIONS LAYERED ON TOP OF WHAT WE ALREADY HAVE, WHICH IS THAT AN EXISTING CONSENT FORM AND BIOBANKING CONSENT FORMS, ET CETERA, FOR STUDIES THAT BIOBANKING STUDIES ALREADY APPROVED BY AN IRB, AVAILABILITY OF THE BROAD CONSENT WOULD NOT UNDERMINE EFFECTIVENESS OF THE OLD BROAD CONSENT OR OLD EXPRESSIONS AND CONTINUING EXPRESSIONS OF BROAD RESEARCH PURPOSES IN STUDIES ACTUALLY APPROVED BY AN IRB. SO THIS IS THE RECOMMENDATION. THE USE OF COMBINED FORM FOR PRIMARY STUDY CONSENT AND BROAD CONSENT, WE SAID THE FOLLOWING. THAT IS THAT WE THINK A CLINICAL CONSENT, SURGICAL, ANESTHESIOLOGY, GENERAL CLINICAL SHOULD NOT BE COMBINED WITH BROAD CONSENT WHEN THE RESEARCHER OR TREATING RESEARCHER WANTS TO OFFER THE BROAD CONSENT. IN GENERAL, WE THOUGHT A BROAD CONSENT SHOULD BE A SEPARATE DOCUMENT. HOWEVER, THERE MAY BE SOME CASES, FOR EXAMPLE, A REGISTRY STUDY WHICH IS ITSELF APPROVED BY AN IRB, THAT MIGHT WANT TO TAKE ADVANTAGE ALSO OF THE NEW BC, NEW BROAD CONSENT, IN WHICH ONE MIGHT HAVE A COMBINED CONSENT FORM SO THE CONSENT FORM FOR BROAD CONSENT IS COMBINED WITH PRIMARY STUDY CONSENT. ONE CAN ALSO IMAGINE STUDIES, ESPECIALLY INCREASINGLY WITH PERSONALIZED MEDICINE, THERE ARE STUDIES THAT ARE DONE IN WHICH DNA IS EXTRACTED OR BIOMATERIALS ARE EXTRACTED FROM A PERSON, PROCESSED SPECIFICALLY FOR THAT PERSON, RETURNED TO THE PERSON, ADMINISTERED TO THE PERSON. IT'S EXTREMELY IMPORTANT FOR DESIGN OF STUDIES THAT THERE IS A CONTINUED ABILITY OF THE RESEARCHERS TO CONTINUE TO USE THOSE MANUFACTURED PRODUCTS DOWNSTREAM. THIS IS NOT A ONE-TIME DEVICE STUDY OR ONE-TIME SMALL MOLECULE STUDY BUT IN FACT WHICH THE ITEM IS ADMINISTERED AND THEN THE DATA ARE ANALYZED. THE KIND OF STUDIES I'M REFERRING TO WHEN THERE ARE PERSONALIZED BIOMATERIALS THAT ARE MANUFACTURED, THE STUDIES DESIGN AND RESEARCH PROGRAM DEPENDS ON ABILITY TO USE PERSONALIZED BIOMATERIALS DOWNSTREAM. IN THOSE SITUATIONS, ONE OUGHT TO BE AS A RESEARCHER ABLE TO EXPRESS THAT TO THE IRB AND COMBINE THE CONSENT FORM THE PRIMARY STUDY WITH THE BROAD CONSENT SO ESSENTIALLY ONE EITHER OPTS INTO THE STUDY WITH THE BROAD CONSENT OR ONE DOESN'T OPT IN TO THE PRIMARY STUDY AT ALL. THERE ARE SOME SITUATIONS IN WHICH, IN OTHER WORDS, A BROAD CONSENT SHOULD BE ALLOWED TO BE COMPOUNDED WITH A PRIMARY STUDY CONSENT. SO THOSE ARE THE HIGHLIGHTS OF THE DRAFT GUIDANCE. I'M HAPPY TO -- YOU'LL HAVE TO HELP ME, JULIA AND CECILIA, PUT THE TEXT OF THE BROAD CONSENT UP HERE BECAUSE I DON'T KNOW HOW TO DO IT. BUT I'M HAPPY TO GO THROUGH THE TEXT OF IT AND TAKE ANY PARTICULAR COMMENTS THAT ANYBODY HAS, WHATEVER -- HOWEVER STEPHEN WANTS TO DO IT. STEPHEN, I'LL TURN IT BACK OVER TO YOU. >> THANK YOU, MARK. THAT WAS A GREAT SUMMARY OF WHAT'S BEEN A COMPLEX TOPIC AND WE'VE HAD COMPLICATED DISCUSSIONS. I THINK THAT IT IS PROBABLY APPROPRIATE TO GO THROUGH THE DRAFT GUIDANCE. I'LL JUST ASK JERRY ONE THING, WHICH IS THAT I HADN'T THOUGHT OF THIS AS THE OBC AND THE NBC. SO IN THE -- UNDER THE NEW RULE, THE FINAL COMMON RULE, WILL THERE STILL BE AN OBC? AND INSTITUTION THAT WANTS TO DO THAT, DOES THAT TRIGGER OR DO THEY STILL HAVE THE ABILITY TO DO WHAT THEY ARE DOING? >> YEAH, THANK YOU, MARK. IT WAS AN EXCELLENT DISCUSSION AND YOU REALLY LAID OUT THE ISSUES VERY WELL. I THINK FROM A REGULATORY VIEWPOINT, ON OUR END WE WOULD NOT REFER TO OLD BROAD CONSENT BECAUSE IT WASN'T BROAD CONSENT. I MEAN IF YOU'RE TALKING ABOUT THE CHECKLIST THAT OCCUR AT THE END OF CLINICAL TRIALS AND SAY ARE YOU OKAY WITH THIS BEING USED FOR CARDIOLOGY RESEARCH, BECAUSE IT WAS A CARDIOLOGY STUDY, OR CANCER RESEARCH OR WHATEVER IT IS, THOSE FORMALLY SHOULD ALLOWING DE-IDENTIFIED TO BE USED DOWNSTREAM FOR FUTURE RESEARCH, IF KEVIN AND OTHERS WANT TO COMMENT ON THE FDA VIEWPOINT, WHAT PHARMACEUTICAL& COMPANIES AND OTHERS DO IN THOSE SCENARIOS. BUT SO IN THAT VIEWPOINT OR THE OTHER EXAMPLE CREATING REPOSITORY IT WASN'T BROAD CONSENT BECAUSE YOU WERE CONSENTING TO ONE STUDY, NAMELY PLOPPING THE STUFF INTO A REPOSITORY, THE REPOSITORY WAS ALLOWED TO STORE IT, GIVE IT OUT TO RESEARCHERS IN A DE-IDENTIFIED WAY IN WHICH WAYS THAT WOULDN'T BE HUMAN SUBJECT RESEARCH. SO THE PERSON NEVER HAD TO CONSENT TO THAT. OR ALTERNATIVELY THERE WOULD HAVE BEEN A WAIVER, WHY THAT RESEARCH WAS ALLOWED. THE HOPEFULLY RELATIVELY RARE SCENARIOS SOMEBODY INTERPRETS THE CONSENT FORM IS ALLOWING WITHOUT WAIVER DOWNSTREAM USE FOR PARTICULAR RESEARCHERS, THERE'S NOTHING IN THE CURRENT RULES THAT ACTUALLY SAYS THAT IS ALLOWABLE, AND AGAIN I'M NOT GOING TO GUESS IN TERMS OF HOW OFTEN THAT DOES HAPPEN AND NOBODY ACTUALLY WORRIES ABOUT IT. SO TO BE MORE ACCURATE IT'S PROBABLY BEST NOT TO USE THE CONCEPT OF OLD BROAD CONSENT. >> I THINK PART OF THIS HAS BEEN I'VE HAD A LOT OF CONFUSION ABOUT THIS BECAUSE WHAT MARK DESCRIBES AS THE INSTITUTIONAL USE OF THIS, WHICH WE REALLY STARTED TO TALK ABOUT IN THE CONTEXT OF THE NPRM WHICH WOULD HAVE REQUIRED IT, NOW WE'RE HEARING THAT THERE ARE FRONT-DOOR CONSENTS AND THINGS DONE AT THE ACADEMIC MEDICAL CENTERS WHERE YOU COME IN THE DOOR AND SIGN SOMETHING THAT SAYS MY STUFF IS GOING TO BE USED FOR RESEARCH BECAUSE THIS IS A TEACHING HOSPITAL OR AN ACADEMIC MEDICAL CENTER. MY UNDERSTANDING OF THAT IS THAT THAT'S FINE, THAT YOU CAN USE THE DE-IDENTIFIED AS YOU ALWAYS COULD, BUT IF YOU'RE DOING ACTUALLY STUDIES FOR SUBSEQUENT STUDIES THAT ARE -- THAT GO THROUGH IRB REVIEW FOR THAT DATA THEY STILL HAVE TO GET A WAIVER OR GO THROUGH CONSENT REQUIREMENT SO IT DOESN'T GET YOU THE ADVANTAGES, IT'S ALMOST A NOTICE BECAUSE IT HAS FEW IF ANY CONSEQUENCES. >> SO LET ME ASK JERRY A SLIGHTLY TOUGHER QUESTION, WHICH IS WHAT ABOUT A PRIMARY STUDY, TAKE AN EXAMPLE, HIV, A PRIMARY DRUG STUDY WITH HIV BIOSPECIMENS ARE COLLECTED AND THE INFORMED CONSENT SAYS WE WILL USE YOUR IDENTIFIABLE DATA AND IDENTIFIED BIOSPECIMENS FOR PROTOCO, WE ALSO HAVE THREE OTHER PROTOCOLS CLOSELY RELATED AND WE DON'T KNOW EXACTLY WHAT WE'RE GOING TO DO BUT IT WILL BE RELATED TO TRYING TO TEST EFFICACY OF NEW ANTIRETROVIRAL ON YOUR SPECIMENS TO USE THEM IN VITRO AND SO YOU'RE CONSENTING AND CHECK A BOX. THAT'S NOT A -- I WOULD NOT CALL THAT A BROAD CONSENT EITHER NEW OR OLD, BUT IT IS WITH A CONSENT TO SOMEWHAT UNSPECIFIED FUTURE USE. MANY OF US THAT THAT WAS ACCEPTABLE IN THE PAST. SO HOW DOES THAT WORK OUT? >> YEAH, I MEAN, THAT'S CLEARLY A MORE DIFFICULT QUESTION. I MEAN, YOUR ISSUE IS ARE YOU MEETING THE -- YOU KNOW, 116 CRITERIA IN TERMS OF BEING SPECIFIC ENOUGH IN TERMS OF THE PURPOSE OF THE STUDY AND WHAT ACTUALLY HAPPENS IN THE DOWNSTREAM STUDIES, IT PROBABLY DEPENDS ON THE FACTS AND CIRCUMSTANCES. I COULD CERTAINLY IMAGINE IF YOU HAD ENOUGH DETAILS WHAT THE STUDIES WERE ABOUT THAT COULD THEORETICALLY BE ACCEPTABLE IN TERMS OF MEETING THE CONSENT CRITERIA. AGAIN, YOU PROBABLY WOULDN'T CALL IT A BROAD CONSENT. WE'RE GIVING ENOUGH SPECIFICS SO THAT YOU MET THE CONSENT CRITERIA ON ALL THE SPECIFIC DOWNSTREAM STUDIES THAT THE PERSON IS BEING ASKED TO CONSENT TO. >> LBC, A LITTLE BROAD CONSENT. [LAUGHTER] YOU DON'T HAVE TO SAY THAT TOO. >> ANY OTHER GENERAL COMMENTS OR QUESTIONS TO MARK? JIM? >> TWO THINGS. FIRST, MANY -- IF THE CONCEPT OF BROAD CONSENT IS GOING TO BE APPLIED, I THINK IT IS BROADLY IN LARGE RESEARCH STUDIES, WHERE BIOLOGICAL SPECIMENS ARE STORED FOR SPECIFIC REASONS, BUT THEN THAT BECOMES VALUABLE RESOURCE FOR DOING OTHER THINGS, FOR INSTANCE TECHNOLOGIES THAT DIDN'T EXIST AT THE TIME THAT THE SPECIMENS WERE COLLECTED, BUT NOW CAN BE APPLIED, I WOULD THINK THAT THE BROAD CONSENT WOULD LIST A BROAD NUMBER OF RESEARCHERS THAT COULD POTENTIALLY ACCESS IT AND THE RESULT THEN WOULD BE IF THE SUBJECT REFUSED, IT WOULD EFFECTIVELY REMOVE SAMPLES OR COLLECTED CLINICAL DATA FOR USE BY ANYONE. WHAT JERRY SAID ABOUT CHECK THE BOX THE LANGUAGE SAYS SOMETHING LIKE OTHER RESEARCHERS MAY APPLY FOR ACCESS TO THE SAMPLES, OTHER RESEARCHERS IF THEY SAY NO PRETTY MUCH GAME OVER. AND THEN YOU TALKED ABOUT THE PRESENT SITUATION OF ALLOWING PEOPLE TO AGREE TO ADDITIONAL RESEARCH ON THEIR SPECIFIC DISEASE, ADDITIONAL GENERAL MEDICAL RESEARCH, AND OFTEN IN SOME OF THE APPLICATIONS I'VE SEEN THERE'S BEEN A SPECIFIC CHOICE AS TO WHETHER OR NOT YOU WOULD AGREE TO GENETIC RESEARCH. IS THAT AN OPTION FOR THE IMPLEMENTATION OF BROAD CONSENT? >> I WOULD SAY THAT THAT'S ACTUALLY NOT AN OPTION FOR THE IMPLEMENTATION OF THE REGULATORY BROAD CONSENT. BUT IT'S AN OPTION THAT REMAINS UNDER THE EXISTING -- UNDER THE OTHER PROVISIONS OF THE COMMON RULE, BUT IF THE PERMISSION LACKS REQUISITE SPECIFICITY THE INSTITUTION OR IRB MIGHT REQUIRE ACTIVE OR WAIVER OF CONSENT FOR THE PURPOSE OF GRANTING WAIVER OF CONSENT PRESUMABLY THE IRB WOULD LOOK AT THAT GENERAL EXPRESSION OR SPECIFIC EXPRESSION THE PERSON HAD AGREED TO IN THAT THE FORM YOU'RE TALKING ABOUT, JIM, AND THEN WOULD EITHER AGREE TO GRANT THE WAIVER OR NOT. SO I THINK THAT WHAT YOU'RE TALKING ABOUT WOULD STILL BE VIABLE, BUT IT WOULD JUST BE THAT IT'S NEITHER MADE BETTER NOR WORSE BY ADVENT OF THE REGULATORY BROAD CONSENT. >> I HAVE A QUESTION. SO IF SOMEONE IS OFFERED A BROAD CONSENT BY THE SURGERY DEPARTMENT, AND THEY REFUSE IT, AND THEY ACCEPT IT, THEY SIGN IT, CAN, SAY, THE ONCOLOGY DEPARTMENT THEN DO RESEARCH WITH THIS INFORMATION UNDER BROAD CONSENT? THERE SEEMS NO BAR TO THAT HAPPENING. IT'S BROAD CONSENT. >> THE ANSWER TO THAT IS -- THE ANSWER ACTUALLY IS NO. IT DEPENDS ON -- ENTIRELY DEPENDS ON WHO ARE THE BENEFICIARIES OF THE BROAD CONSENT, EXPRESSED IN THE BROAD CONSENT. SO IF THE BROAD CONSENT OFFERED BY THE SURGERY DEPARTMENT WAS ON BEHALF OF THE ENTIRE HOSPITAL INCLUDING THE ONCOLOGY DEPARTMENT AND INFECTIOUS DISEASE DIVISION AND EVERYTHING ELSE, THE OTHER RESEARCHERS COULD USE IT. IF ON THE OTHER HAND THE DEPARTMENT OF SURGERY OFFERED CONSENT THAT SAID DEPARTMENT OF SURGERY IS THE BENEFICIARY AND WILL DO THE RESEARCH THE ANSWER TO YOUR QUESTION IS NO. >> OKAY. SO IF THE BROAD CONSENT IS OFFERED THAT COVERS THE ENTIRE INSTITUTION, AND THE PERSON -- BY THE DEPARTMENT OF SURGERY, THEY ARE IN FOR SURGERY, AND THE PERSON REFUSES, IS IT STILL THEN ALLOWABLE THAT THE ONCOLOGY DEPARTMENT CAN THEN SUBSEQUENTLY OFFER THEM CONSENT GIVEN THAT THEY HAVE REFUSED? >> IT'S NOT CLEAR UNDER THE REGULATION. IT DOESN'T SAY. WHAT THIS SAYS IS THERE SHOULD BE -- THAT THE REOFFERING OF A BROAD CONSENT SHOULD BE DONE -- WE FIRST SAID AFTER A DECENT INTERVAL. PEOPLE DIDN'T LIKE THAT, THERE WAS DISCUSSION ABOUT WHAT DECENT INTERVAL WAS OR WASN'T. IT'S EXPRESSED IN THE TEXT BUT ONE COULD NOT REOFFER BROAD CONSENT IN THE SAME INSTITUTION WITHOUT A REASONABLE COOLING OFF PERIOD AND -- OR MAJOR CHANGE IN THE PATIENT'S CIRCUMSTANCES I THINK IS WHAT WE SAID. >> JIM'S SCENARIO, YOU WERE ASKED ABOUT THE PERSON WHO WANTED TO GIVE CONSENT FOR EXAMPLE GENOMIC TYPE RESEARCH AND CERTAIN BIOSPECIMENS, IS THAT THE SORT OF EXAMPLE YOU WERE DEALING WITH? >> SO I WAS SUGGESTING A SCENARIO WHERE WHERE FOR WHATEVER REASON A RESEARCH SUBJECT WOULD AGREE TO ALL RESEARCH EXCEPT GENETIC RESEARCH. >> OKAY. >> THE ANSWER WHAT I HEARD WAS UNDER THE IMPLEMENTATION OF BROAD CONSENT, IT WAS -- YOU AGREE TO ANYTHING OR YOU AGREE TO NOTHING. >> OKAY. SO THIS GETS BACK -- IT IS AN IMPORTANT POINT GETTING BACK TO MARK'S POINT ABOUT OLD BROAD CONSENT AND NEW BROAD CONSENT. THERE ISN'T A LOT OF BROAD CONSENT OUT THERE. THERE ARE A LOT OF COMPLICATIONS, IN TERMS OF ALLOWING THE PERSON TO CONSENT PROSPECTIVELY TO RESEARCH WHEN THEY DON'T KNOW WHAT RESEARCH WILL INVOLVE. IN AN INSTITUTION OR RESEARCHERS FOUND IT USEFUL TO WRITE A CONSENT FORM THAT ARE BASICALLY SAID I'M CONSENTING TO THE FOLLOWING TYPES OF RESEARCH, BUT NOT, AND THEN YOU COULD SPELL OUT A WHOLE BUNCH OF DIFFERENT TYPES OF RESEARCH THIS RESEARCHER KNOWS A LOT OF THE PATIENTS HE DEALS WITH DO NOT LIKE THAT TYPE OF RESEARCH, MAYBE IT'S GENOMIC RESEARCH, WHATEVER IT IS, THERE'S NO REASON UNDER THESE RULES YOU COULDN'T GRAB THAT KIND OF CONSENT FORM. PEOPLE SHOULD EXCEPT THAT THERE'S ACTUALLY AN INCREASED ABILITY TO FASHION NEW TYPES OF BROAD CONSENT FORMS BECAUSE WE SEARCHERS NOW DO HAVE A TYPE OF AUTHORITY THAT IT DOESN'T EXIST UNDER THE CURRENT RULES BECAUSE THERE REALLY ISN'T BROAD CONSENT. THE MOMENT YOU GET BROAD CONSENT NOT TELLING THE PERSON THE SPECIFICS OF EVERY PARTICULAR STUDY THAT YOU WANT TO USE, YOU KIND OF ARE IN MUDDY WATERS WHERE THE NEW RULE ALLOWS THAT TO HAPPEN. WHAT THE MOST COMMON CONSENT FORMS WILL BE IN THIS TYPE OF SCENARIO WE DON'T KNOW. THAT'S ULTIMATELY FOR RESEARCHERS TO DETERMINE WHAT FORMS THEY WANT TO USE BUT THE FLEXIBILITY IS THERE AND IT DOES ALLOW THIS SORT OF THING TO TAKE PLACE. >> YOU RAISE TWO POINTS, MARK, THAT GOT MY HEART RATE INCREASED. I WANTED TO APOLOGIZE IF WE TALKED ABOUT THESE THE LAST TIME. IF WE DID, I DON'T REMEMBER. SO IT SEEMS LIKE IN YOUR DISCUSSION OF THE NEW BROAD CONSENT THAT YOU'RE MAKING A DECISION BETWEEN GENETIC AND GENOMIC. THAT IT'S OKAY TO STUDY BRCA 1 AND 2, BUT NOT TO DO WHOLE GENOME SEQUENCING WITHOUT SPECIFIC ENUNCIATION OF THAT. >> I THINK THE ANSWER IS NO TO THAT. WHAT THE REGULATIONS -- THE REGULATORY BROAD CONSENT SAYS IF YOU WANT LATER TO DO WHOLE GENOME SEQUENCING WITH THE IDENTIFIABLE BIOSPECIMEN YOU MUST ACTUALLY SAY THAT IN THE BROAD CONSENT. SO THEREFORE YOU WILL SEE IN THE TEMPLATE BROAD CONSENT WE SAY THIS MAY BE YOUR ARE -- YOUR BIOSPECIMEN MAY BE USED FOR WHOLE GENOME SEQUENCING. THAT'S FOR THE SPECIAL REGULATORY PURPOSES. 25 STATES HAVE SPECIFIC CONSENT REQUIREMENTS FOR GENTIC TESTING. IF YOU WANT AS A RESEARCHER OR INSTITUTION TO BE ABLE TO USE THE BIOSPECIMEN FOR GENETIC TESTING LATER TO TAKE ADVANTAGE OF EXEMPTION, YOU'RE ALSO GOING TO HAVE TO PUT SOME REFERENCE TO GENETIC TESTING INTO THE BROAD CONSENT. >> OKAY. >> OKAY? >> OKAY. THANK YOU. THE SECOND POINT -- >> IS YOUR HEART RACING LESS? >> NO, BECAUSE THIS NEXT POINT -- [LAUGHTER] -- IS EQUALLY STIMULATING TO ME, THE NOTION OF INCIDENTAL FINDING. >> YES. >> AND SO I THINK WE CAN ALL APPRECIATE IF YOUR STUDY INVOLVES DOING A CHEST X-RAY AND YOU SEE A HEPATOMA IN THE DOME OF THE LIVER THAT'S AN INCIDENTAL FINDING AND YOU MAY WANT TO ADDRESS THAT. IF NOT, THE TERMS OF YOUR RESEARCH, CERTAINLY LEGALLY. >> RIGHT. >> BUT THE NOTION OF INCIDENTAL FINDING HAS MUCH BROADER APPLICABILITY WHEN YOU'RE TALKING ABOUT GENETIC OR PARTICULARLY GENOMIC RESEARCH. >> RIGHT. >> AND WHAT'S THE VIEW OF INCIDENTAL FINDINGS FOUND ON GENOMIC RESEARCH BECAUSE IF I LOOK AT YOUR DNA OR YOU LOOK AT MINE WE'RE GOING TO FIND ALL SORTS OF INCIDENTAL FINDINGS THAT MIGHT BE IMPORTANT TO OUR HEALTH GOING FORWARD. >> I WOULD SAY THAT THE INTERPRETATION -- YOU'RE EXACTLY RIGHT, I THINK. THE INTERPRETATION OF THAT UNDER THIS WOULD BE I THINK THE FOLLOWING, THE INTERPRETATION WOULD BE, IF THE REGULATORY TO WHOLE GENOME SEQUENCING, THEN YOU ARE -- YOU AS A RESEARCHER ARE AL ALLOWED TO DO WHOLE GENOME SEQUENCING BUT WOULD NOT BE ABLE TO RETURN RESULTS OF SIGNIFICANCE OF VARIANTS WHATEVER IT IS NOW, 51 OR WHATEVER THE LIST IS OF THE RECOGNIZED VALIDATED ASSOCIATIONS, YOU WOULDN'T BE ABLE TO DO THAT UNLESS -- WOULDN'T BE ABLE TO TAKE ADVANTAGE -- YOU COULD DO THE WHOLE GENOME SEQUENCING BUT NOT A STUDY IN WHICH YOU INTENDED TO RETURN ANY OF THESE RESULTS TO SUBJECTS, TO THE HUMAN SOURCES OF THESE BIOSPECIMENS, AND TAKE ADVANTAGE OF THE EXEMPTION. YOU WOULD HAVE TO GO TO THE IRB, YOU WOULD HAVE TO PROPOSE A STUDY, AND THEY WOULD SAY YOU EITHER MUST GET SPECIFIC CONSENT OR YOU MUST GET WAIVER OF CONSENT, IN THAT PROTOCOL YOU WOULD DEFINE IN YOUR PROTOCOL EXACTLY WHAT VARIANT RESULTS YOU WOULD INTEND TO RETURN TO THE SUBJECT. BUT IF YOU DIDN'T DO THAT, IF ALL YOU DID WHAT IS WHOLE GENOME SEQUENCING AND FOUND LOTS OF STUFF, AND YOU WILL FIND LOTS OF STUFF IF YOU ACTUALLY LOOK AT THE RESULTS THAT YOUR RESEARCH YIELDED, WHICH YOU ARE GOING TO DO OR YOU WOULDN'T HAVE SPENT THE MONEY FOR WHOLE GENOME SEQUENCING, THOSE WOULD NOT BE INCIDENTAL FINDINGS. THOSE WOULD BE EXPECTED FINDINGS OF THE STUDY. AND THEN YOU WOULD NEED -- IF YOU INTEND TO RETURN THEM -- IF YOU DON'T INTEND TO RETURN THEM YOU DON'T HAVE A PROBLEM. BUT IF YOU INTEND TO RETURN THEM THAT WOULD TAKE YOU OUTSIDE OF THE EXEMPTION. THAT'S HOW I WOULD INTERPRET IT. >> I WANT TO ASK JERRY YOU ABOUT I THINK I KNOW THE ANSWER. IT WOULD BE INTERESTED TO SEE WHAT PEOPLE WERE WRITING AS BROAD CONSENT BUT UNDER THE POSTING OF CONSENT REQUIREMENTS I DON'T BELIEVE THE BROAD CONSENT FALLS UNDER THAT. IT WOULD HAVE BEEN INTERESTING. >> ALL RIGHT. LET'S GO AHEAD WITH -- >> OKAY >> -- THE ACTUAL DOCUMENT. >> OKAY. SO INTRODUCTION HERE THAT GIVES YOU THE REGULATORY FRAMEWORK OF ALL OF THIS. WHAT ELEMENTS HAVE TO BEULE,- INCLUDED IN THE BROAD CONSENT FOR THE BROAD CONSENT TO HAVE -- TO BE EFFECTIVE AND THEREFORE GIVE ONE THE ABILITY TO ACCESS THE EXEMPTIONS. SO YOU CAN SEE, FOR EXAMPLE, JUST GETTING BACK TO REID'S POINT, WHEN APPROPRIATE FOR RESEARCH INVOLVING BIOSPECIMENS THERE'S A TYPO THERE, WHETHER RESEARCH WILL IF KNOWN OR MIGHT INCLUDE WHOLE GENOME SEQUENCING SO THAT MUST BE ACTUALLY EXPRESSED IF YOU INTEND TO TAKE ADVANTAGE OF THE EXEMPTION IN ORDER TO DO THAT. OKAY? >> COULD I JUST POINT OUT THAT WHOLE GENOME SEQUENCING LOOKS AT ALL 6 BILLION OF YOUR NUCLEOTIDES, WHOLE EXOME SEQUENCING LOOKS AT 2% BUT SHOULD FALL UNDER THIS AS WELL, IF YOU DO WHOLE GENOME IT SHOULD SAY WHOLE EXOME. >> WHERE? I'M SORRY. THAT'S ON THE NEXT PAGE. >> REID, WE'LL COME TO THAT WHEN WE LOOK AT TEMPLATE BROAD CONSENT, OKAY? AGAIN, PAGE 4, THIS IS GOING THROUGH THE BACKGROUND REGULATORY STRUCTURE HOW THIS FITS INTO THE BACKGROUND REGULATORY STRUCTURE. THE ESSENTIAL INFORMATION ABOUT THIS WAS ACTUALLY ON THE SLIDES THAT I HAD GONE THROUGH. THEN WE GIVE A DESCRIPTION OF HOW THIS CHANGED FROM NPRM TO THE FINAL RULE. AS YOU MAY REMEMBER THOSE ON THE COMMITTEE, ON THE SUBCOMMITTEES AT THE TIME, THIS COMMITTEE ABOUT A LOT OF WORK IN COMMENTING ON THE ORIGINAL BROAD CONSENT PROPOSAL AND ANPRM AND NPRM. THIS HIGHLIGHTS THAT. THEN WE GET AT THE BOTTOM OF PAGE 5, OF 17, WE GET TO THE ISSUE OF HOW TO INTERPRET AND IMPLEMENT BROAD CONSENT. WE TALK HERE ABOUT SOME OF THE PRACTICAL PROBLEMS IN TRYING TO IMPLEMENT THE BROAD CONSENT ON AN INSTITUTION-WIDE BASIS, WHICH IS WHAT WE HAD DISCUSSED BEFORE. WE ALSO TALK ABOUT THE OPTION ACTUALLY OF JUST DEIDENTIFYING THE INFORMATION AND DEIDENTIFYING THE BIOSPECIMEN AND BEING ABLE TO USE IT AS ONE SEES FIT EVEN IF THE PERSON DECLINED CONSENT, DECLINED BROAD CONSENT. NEED FOR SEAMLESS I.T. SYSTEM TO TRACK REFUSAL OF BROAD CONSENT UNDER THE REGULATORY BROAD CONSENT. THEN WE GET TO AT THE BOTTOM OF THAT PAGE HOW TO DEFINE REFUSAL TO CONSENT. THIS GOES ON FOR 4 PAGES BECAUSE THIS WAS -- WE TALKED -- SPENT A COUPLE HOURS I THINK ON THIS ISSUE, AT THIS LAST MEETING AND SPENT AT LEAST I WOULD SAY 10 OR 12 HOURS ON THE SUBCOMMITTEE TALKING ABOUT HOW TO DEFINE REFUSAL TO CONSENT. WHAT FOLLOWS IS RATIONALES FOR TREATING A NON-ANSWER, WHETHER TO TREAT THAT AS REFUSAL TO CONSENTS OR NOT WITH COMING DOWN ON THE SIDE ONE SHOULD TREAT A NON-ANSWER THAT DOES NOT HAVE UNAMBIGUOUS REFUSAL TO GIVE BROAD CONSENT AS ESSENTIALLY NOTHING, HAVING NO LEGAL EFFECT, NEITHER GRANTING BROAD CONSENT NOR REFUSAL OF BROAD CONSENT. IF YOU LOOK ON -- I DON'T HAVE THE LINES UP HERE. THIS IS THE TOP OF PAGE 8. I DO WANT TO POINT THIS OUT. THIS WAS ONE PARTICULAR SUBJECT OF DISCUSSION AT THE END OF THAT FIRST PARAGRAPH. FOR PERSONS WHO DON'T ANSWER, THAT IS WHO DON'T GIVE THE BROAD CONSENT NOR DO THEY UNAMBIGUOUSLY REFUSE TO GIVE BROAD CONSENT, WE RECOMMENDED IN THIS DRAFT THAT AS A BEST PRACTICE AND AS PRACTICE THAT'S APPROPRIATELY RESPECTABLE AUTONOMY FOR PERSONS OFFERED THROUGH MEDIUM OTHER THAN FACE TO FACE CONTACT, THAT IS BY INTERNET OR E-MAIL, THAT ONE SHOULD HAVE -- BEFORE ONE THINKS THIS IS A NON-RESPONSE AND CREDITS IT IN THAT WAY, ONE SHOULD OFFER THE BROAD CONSENT A SECOND TIME. AND BE ABLE TO DEMONSTRATE IT WAS OFFERED A SECOND TIME. TO MAXIMIZE THE INDIVIDUAL'S& OPPORTUNITY TO OPT OUT. FACE TO FACE IS SOMEWHAT DIFFERENT WE THOUGHT BECAUSE THE PERSON IS MORE LIKELY TO BE ABLE TO EITHER ACKNOWLEDGE OR NOT ACKNOWLEDGE, REFUSE OR GRANT THE BROAD CONSENT. SO THAT WAS THAT DISCUSSION. THE NEXT POINT, SHALL I -- YEAH. THIS WAS THE ISSUE THAT YOU GUYS HAVE RAISED, ABOUT WHICH YOU RAISED QUESTIONS TODAY. THAT IS WHO ARE THE PARTIES BOUND BY REFUSAL TO GIVE BROAD CONSENT. I WANT TO POINT OUT ONE -- I THINK I ANSWERED THE SPECIFIC HYPOTHETICALS. WE'RE TRYING TO COME UP WITH A REASONABLE INTERPRETATION OF THIS. THERE IS A PROBLEM BECAUSE IF YOU HAVE LENNOX HILL HOSPITAL SURGERY DEPARTMENT OFFERING A BROAD CONSENT WHICH SAYS THIS BROAD CONSENT IS IN FAVOR OF EVERY RESEARCHER IN THE WORLD, AND THE PERSON REFUSES THE BROAD CONSENT, THEN UNDER THIS KIND OF RECIPROCITY THAT WE HAVE -- THE PRINCIPLE WE ARTICULATED, THAT WOULD ACTUALLY BAR ANYONE IN THE ENTIRE WORLD FROM EVER BEING ABLE TO USE THE WAIVER OF CONSENT. THAT DOESN'T SEEM LIKE A GOOD RESULT BECAUSE ANYBODY COULD OFFER ANYTHING. ON THE OTHER HAND, YOU KNOW, I DON'T KNOW WHAT THE ALTERNATIVE IS. YOU KNOW, ONE THING THAT WOULD HAPPEN IN PRACTICE IS THAT ONE WOULD EXPECT THAT AN INSTITUTION WOULD LOOK CAREFULLY AT WHO IS OFFERING THE BROAD CONSENT, WHO IS AUTHORIZED TO OFFER THE BROAD CONSENT, AND WHAT THE FORM IS THAT THEY ARE USING BECAUSE THE INSTITUTION, IF IT'S GOING TO HAVE A BROAD OFFERING OF BROAD CONSENT, HAS A LOT TO EITHER LOSE OR GAIN IN THE OFFERING OF BROAD CONSENT. SO I THINK PRACTICALLY SPEAKING THAT WILL NOT HAPPEN VERY OFTEN BECAUSE THERE WILL BE SOME INSTITUTIONAL ATTENTION TO WHO IS AUTHORIZED TO OFFER BROAD CONSENT AND WHO IS NOT. THAT'S ONE PRACTICAL REALITY. THE OTHER PRACTICAL REALITY IS BROAD CONSENT MAY BE OFFERED AT THE HOSPITAL, AT THE AMERICAN UNIVERSITY IN BEIRUT, AND BY ITS TERMS MAY BE IN FAVOR OF EVERYONE, EVERY RESEARCHER IN THE ENTIRE WORLD BUT THE FACT IS WE IN NEW YORK AT SLOAN KETTERING WOULD NEVER KNOW THAT WAS ACTUALLY REFUSED AT THE TIME. SO THAT WOULD NOT -- AND THAT WOULD NOT STOP US FROM OFFERING OUR OWN BROAD CONSENT, THAT IT WOULD BE DISTILLED TO OUR OWN REQUIREMENTS, AND WOULD RUN IN FAVOR OF OUR OWN RESEARCHERS. STEPHEN, DO YOU WANT TO SAY SOMETHING ABOUT THAT? >> NO. I THINK THAT'S COMMON SENSE. >> SO THIS -- BUT ONE OF THE QUESTIONS THAT WE DID TALKED ABOUT EXTENSIVELY, WHAT IF THE SURGERY DEPARTMENT OFFERS IT, IT'S ON BEHALF OF THE WHOLE INSTITUTION, AND I THINK THE ANSWER TO THAT IS JUST AS I SAID, THAT ONE IS A RESPONSIBLE INSTITUTION SHOULDN'T LET THE SURGERY DEPARTMENT OFFER SOMETHING BROAD ISSUE THAN WHAT -- BROADER THAN WHAT YOU WANT THE SURGERY DEPARTMENT TO OFFER. THERE HAS TO BE CARE, TO GET ACCESS TO BENEFITS OF THIS EXEMPTION THROUGH THE OFFERING AND OBTAINING OF BROAD CONSENT. ALSO IF YOU LOOK AT THE LAST PART OF THE FIRST PARAGRAPH, REFUSAL TO PROVIDE BROAD CONSENT WOULD NOT PREVENT THE SAME RESEARCHER OR OTHERS FROM CONTACTING OR RECONTACTS AT A FUTURE TIME TO REQUEST, AS LONG AS IT WAS NOT ABUSIVE. I DIDN'T REMEMBER WHAT WORDS WE USED, THESE WORDS WERE DEBATED OVER. IT DID SAY DECENT INTERVAL, THAT WAS TAKEN OUT BUT HOLLY AND OTHERS MAY RECALL MORE SPECIFICALLY THAN I. >> I'M NOT GOING TO SUGGEST MAJOR CHANGES. I'M WONDERING IN THE CONVERSATION NOW WHO THE PARTIES ARE BOUND BY THE BROAD CONSENT, WHETHER WE SHOULD MAKE EXPLICIT SOMETHING THAT'S KIND OF UNDER THE SURFACE, WHICH IS POTENTIALLY A RECOMMENDATION THAT WHEN YOU'RE OFFERING BROAD CONSENT IT BE AT THE NARROWEST GROUPING POSSIBLE, RIGHT? SO THAT AS A RULE YOU OUGHT TO OFFER IT FOR YOUR DEPARTMENT OR FOR THE SMALLEST KIND OF GROUPING THAT YOU CAN TO AVOID RUNNING INTO THIS PROBLEM. I THINK THAT WORKS AS A RECOMMENDATION. THEN YOU DON'T GET THE BENEFIT OF IT, FROM THE INSTITUTION-WIDE PERSPECTIVE IF PEOPLE SAY YES. LIKE I CAN'T TELL WHETHER THAT'S WORD THE TRADEOFF BUT I DO WORRY ABOUT THE IMPACT OF TOO BROAD OF A REFUSAL SO I'M WONDERING WHAT OTHER PEOPLE THINK ABOUT MAKING THAT AN EXPLICIT RECOMMENDATION. >> I THINK IT'S VERY PROBLEMATIC BECAUSE I WAS ENVISIONS HOW WOULD INSTITUTIONS TRY TO GAME THE SYSTEM. AND I DON'T WANT PEOPLE TO DO THAT. ON THE OTHER HAND, I THINK THAT THIS COULD BE REALLY LIMITING IF YOU MAKE IT TOO BROAD. RIGHT NOW WE HAVE INVESTIGATORS ABOUT I MAY WANT TO SHARE THE DATA AND I THINK IT WOULD TAKE A LOT OF EDUCATION THROUGHOUT THE SYSTEM TO GET PEOPLE TO UNDERSTAND, YES, YOU WANT TO BE ABLE TO SHARE DATA BUT YOU CAN'T MAKE THIS SO BROAD THAT OTHER INSTITUTIONS WOULDN'T BE ABLE TO ALSO POTENTIALLY SEEK BROAD CONSENT I CAN EASILY IMAGINE YOU GO TO HOSPITAL A AND YOU'RE NOT HAPPY WITH THEIR DIAGNOSIS. YOU'RE UNHAPPY WITH THE WAY -- YOU GO TO SLOAN-KETTERING, NOW I'M HAPPY TO SIGN THE BROAD CONSENT. HAD YOU REFUSED BEFORE IS THAT A PROBLEM? I THINK THIS IS GOING TO TAKE A LOT OF EDUCATION IF WE'RE REALLY GOING TO NEED PEOPLE TO NARROW THIS. >> I DO WANT TO BRING UP AN ISSUE. RIGHT NOW. THAT'S ABOUT THIS FIRST PARAGRAPH, THE END OF IT. WE'RE TALKING BROAD CONSENT HERE, WE'RE TALKING A LOT OF EMPHASIS ON SPECIMENS INITIALLY CONTAINED OR WILL BE OBTAINED FOR CLINICAL PURPOSES AND THEN THERE WILL BE A FUTURE USE FOR DIFFERENT RESEARCH PURPOSES. I ALSO WANT TO RAISE THE ISSUE OF THE RESEARCH SPECIMENS, WE OBTAIN AS PART OF CLINICAL TRIAL, TALKING ABOUT CHECKING THE BOX, YOU OBTAINED THIS BLUE TOP AND I'M GOING TO KEEP THAT AND USE THIS FOR UNSPECIFIED RESEARCH, WHEN YOU'RE READING THIS DRAFT GUIDANCE AND YOU'RE GOING TO THE END OF THE FIRST PARAGRAPH, CORRECT ME IF I'M WRONG, WHAT I'M READING IS THAT IT'S SAYING THAT IF I'M DOING DE NOVO RESEARCH SPECIMENS WHICH THE SUBJECT ORIGINALLY CONSENTED, THEY SAY NO, I DO NOT WANT YOU TO -- YOU, KAREN JEANS, TO USE THAT FOR BROAD UNSPECIFIED USES OR GENETIC TESTING OR WHATEVER, OTHER ISSUES RELATED TO MY DISEASE. HOWEVER, IT WOULDN'T PREVENT ANOTHER RESEARCHER FROM GOING AFTER MY RESEARCH SPECIMENS AND SEEKING A WAIVER OF CONSENT FROM THE IRB BECAUSE THEY ARE NOT A PARTY THAT WAS NAMED. THAT AN ISSUE I'D LIKE TO BRING UP. >> I THINK IT'S NOT A PROBLEM FOR THE FOLLOWING REASON. THAT IS IN WHAT YOU DESCRIB AS THE CHECK BOX, LIKE THE NCI FORMAT YOU CAN USE THE STUFF FOR FUTURE FOR THIS DISEASE, USE THE STUFF FOR ANY DISEASE, ET CETERA, THOSE CHECK BOXES DO NOT MEET THE REQUIREMENTS OF THE BROAD CONSENT AT ALL. SO WHETHER THE PERSON REFUSES OR DOESN'T REFUSE, FOR THAT PURPOSE, FOR THE PURPOSE THAT YOU ARTICULATED, IN THIS SCENARIO, IS NOT AFFECTED BY ANYTHING IN THAT PARAGRAPH OR ACTUALLY IN THIS GUIDANCE. IN OTHER WORDS, IT DOESN'T TAKE -- THE ONLY EFFECT -- THE SCENARIO YOU DESCRIBED, EFFECT OF A PERSON NOT CHECKING THAT BOX, BECAUSE IT'S NOT A BROAD CONSENT, IT'S NOT A REGULATORY BROAD CONSENT, NOT AFFECTED, CONSEQUENCE IS NOT AFFECTED BY THIS GUIDANCE. >> BUT I AM DOING A BROAD CONSENT. I'M DESIGNING A STUDY UNDER THIS BROAD CONSENT AND THEY HAVE SAID I DID A PRIMARY STUDY WITH THEM, NOW I'M ALSO DOING A SECONDARY BROAD CONSENT SO THEY CAN HAVE FUTURE UNSPECIFIED RESEARCH. THEY SAID NO. I'M NOT GOING TO LET YOU DO IT. >> RIGHT. >> TO ME. BUT HOW WOULD THAT BE INTERPRETED FOR MY DE NOVO SPECIMENS FOR THIS PART, FOR THESE LAST THREE LINES? >> OKAY. IF YOU REALLY ARE -- THERE'S -- I WOULD TELL YOU FIRST OF ALL DON'T DO WHAT YOU SAID. AND THE REASON I WOULD TELL YOU THAT IS BECAUSE IF YOU REALLY THINK THAT THE DOWNSTREAM USE OF THE IDENTIFIABLE BIOSPECIMEN IS NECESSARY AS ADJUNCT TO PRIMARY RESEARCH I WOULDN'T GIVE THE PERSON THE OPTION. IF YOU WANT TO BE IN THE PRIMARY STUDY, YOU'RE CONSENTING TO THE STUDY AND FUTURE USE, IF YOU WANT TO BE -- IF YOU DON'T WANT TO BE IN THE STUDY WITH FUTURE USES, DON'T BE IN THE STUDY. THE SECOND THING NEVERTHELESS YOU IGNORE THAT ADVICE OR IT'S NOT TRUE THE STUFF NEEDS TO BE -- IS AN EXPWEG RAIL -- INTEGRAL PART OF YOUR RESEARCH USE AND YOU OFFER THE BROAD CONSENT, THEN I GUESS YOU HAVE A CHOICE. I COULD MAKE IT IN FAVOR, THE BROAD CONSENT, IN FAVOR OF YOURSELF WHICH WOULD MEAN THAT IF THE PERSON REFUSES, IT WOULD TAKE -- YOUR OWN SMALL RESEARCH TEAM, THAT WOULD TAKE THE ABILITY TO GET WAIVER OF CONSENT OUT OF THAT FOREVER MORE. YOU COULD NEVERTHELESS USE BIOSPECIMENS -- YOU COULD DEIDENTIFY THEM AND ASSOCIATE DE-IDENTIFIED PHENOTYPIC INFORMATION, YOU COULD CONTINUE TO USE THEM. THE BIOSPECIMENS WOULD BE AVAILABLE TO THE LAB NEXT DOOR UNDER WAIVER OF CONSENT IF YOU DRAFTED YOUR BROAD CONSENT IN THE WAY NARROWLY RESTRICTED. ON THE OTHER HAND IF YOU DRAFTED TO SAY MY ENTIRE DEPARTMENT OR ENTIRE INSTITUTION, THEN THE LAB NEXT DOOR WOULDN'T BE ABLE TO USE IT. NOW, THE PERSON DOWN THE STREIGHT STREET MIGHT WANT TO USE IT BUT YOU WON'T ALLOW ACCESS FOR OTHER REASONS. >> I'M GOING TO BE MORE RADICAL THAN HOLLY IN TERMS OF THE LIMITATIONS OF THIS. I THINK, YOU KNOW, WE'RE ALL SORT OF THINKING THERE'S -- TO ME THERE'S SUCH LOGICAL AND PRACTICAL PROBLEMS WITH IMPLEMENTING THIS, AT AN INSTITUTIONAL LEVEL, THAT I REALLY SEE THAT ITS UTILITY IS TO TAKE ADVANTAGE OF THE TWO EXEMPTIONS IN STUDIES DESIGNED FOR THAT. I WONDER AT THE END IF WE SHOULD MAKE THAT A RECOMMENDATION, THAT THIS IS NOT SUPPOSED TO BE OR THIS IS NOT CONSTRUCTED TO BE, I DON'T KNOW WHAT THE INTENT WAS, BUT AS IT TURNED OUT IN OUR CURRENT HEALTH CARE SYSTEM, WHICH IS FRAGMENTED, IT'S REALLY NOT PRACTICAL TO DO THIS AT AN INSTITUTIONAL LEVEL, OR AT EVEN AT A DEPARTMENT LEVEL. THIS IS NOT SOMETHING MEANT FOR LEFTOVER CLINICAL SPECIMENS. THIS IS MEANT ABOUT BUILDING DATA REPOSITORIES AND BIOSPECIMEN REPOSITORIES. IF YOU USE IT BEYOND THAT THERE ARE JUST A LOT OF QUESTIONS THAT MAY BE DIFFICULT TO ANSWER. >> I THINK THAT'S WHAT WE ALL BELIEVE, THE PEOPLE ON THE SUBCOMMITTEE AND COULD MAKE IT MORE EXPLICIT, WITH A COUPLE MORE SENTENCES. I THINK WE ARE PRETTY CLEAR THAT ALREADY MASSIVE PRACTICAL PROBLEMS TO USING THIS ON A BROAD BASIS. WE COULD BEEF IT UP TO SAY WHAT YOU SAID MORE EXPLICITLY. I THOUGHT IT'S CLEAR IN HERE, I'M ONE INCH AWAY FROM IT BECAUSE I'VE BEEN THROUGH THIS SO MUCH. MAYBE THAT POINT DOESN'T COME ACROSS IN THE CURRENT DRAFT. >> I THINK THE REAL ISSUE IS JUST THAT LANGUAGE BROAD CONSENT IS SOMETHING PEOPLE WANT TO BE ABLE TO DO INSTITUTIONAL LEVEL CONSENT, FRONT DOOR CONSENTS, WHATEVER YOU WANT TO CALL THAT. I THINK WE NEED TO BE QUITE CLEAR THIS IS NOT THAT. AND WHEREVER WE PUT IT, I THINK IT SHOULD BE CLEAR BECAUSE OTHER PEOPLE ARE NOT GOING TO SPEND AS MUCH TIME. >> STEPHEN, YOU KNOW, I CAN IMAGINE THOUGH THAT IF I HAD A SMALL HOSPITAL THAT WAS A SPECIALTY HOSPITAL, WITH AN INCREDIBLY COMPLIANT AND GRATEFUL PATIENT POPULATION, I WAS GOING TO GET 99.9% ACCEPTANCE, THAT I COULD ACTUALLY OFFER THIS BROAD CONSENT BUT IT WOULD BE THE UNIQUE SITUATION. >> WE COULD JUST START THE RECOMMENDATION BY SAYING IN GENERAL. >> I AGREE WITH THE POINT, YEAH. >> OKAY. >> SO ONE THING THAT'S TROUBLED ME ABOUT THIS FROM THE BEGINNING, IT'S NOT THE KIND OF WORK I DO SO MAYBE YOU CAN HELP ME, HOW DIFFICULT IT IS TO SAY NO. BECAUSE YOU'RE OFFERED THIS AND YOU SAY NO, OKAY, AND THEN YOU'RE OFFERED IT AGAIN. AND YOU BETTER BE READING YOUR E-MAIL OR BE ANSWERING ALL OF YOUR MAIL BECAUSE EVEN THOUGH YOU SAID NO ONCE, IF YOU FAIL TO SAY NO A SECOND TIME, THEN YOU'RE GOING TO BE IN THE YES OR NO CATEGORY BECAUSE YOU FAILED TO RESPOND TO THE SECOND ATTEMPT TO GET YOU TO DO IT. SO ESSENTIALLY, YOU CAN'T JUST SAY NO. I DON'T WANT YOU TO DO THIS AND I DON'T WANT TO BE ASKED AGAIN. YOU ARE ALWAYS GOING TO BE COMING UP AGAIN AND AGAIN AND AGAIN WITH ANOTHER REQUEST AND ANOTHER REQUEST AND ANOTHER REQUEST, AND IF YOU DON'T RESPOND THEN YOU'RE IN A DIFFERENT CATEGORY THAN THE ONE YOU INITIALLY SAID YOU WANTED TO BE IN. SO MAYBE YOU COULD HELP ME WITH THIS. >> ONE THING IS THAT I WOULD REGARD AN INSTITUTION OR RESEARCH OR OFFERING A BROAD CONSENT AGAIN AND AGAIN AND AGAIN AS BEING INSISTENT AND ABUSIVE AND WOULD REGARD THAT AS PRINCIPLE ARTICULATED IN THE GUIDANCE. THAT'S ONE THING. THE SECOND THING IF A PERSON DOESN'T -- IF A PERSON DOESN'T ACTUALLY -- ACTUALLY NEVER SAYS NO OR DOESN'T RESPOND THEY ARE NO WORSE OFF IF THEY HAD NOT BEEN OFFERED TO BEGIN WITH. THEY ARE NOT TREATED DIFFERENTLY. >> YES, BUT IF THEY SAY NO, AND THEN THEY ARE ASKED AGAIN, BECAUSE YOU CAN BE RECONTACTED AGAIN ONCE YOU SAID NO, AFTER A DECENT INTERVAL IN A NON-ABUSIVE WAY, AND THEY FAIL TO RESPOND THAT SECOND TIME -- >> I AGREE WITH MARK'S TAKE BUT YOU'RE GIVING A DIFFERENT SCENARIO. THEY HAVE GIVEN YOU AN ANSWER THE FIRST TIME, BASICALLY SAYING THEY DON'T WANT THIS DONE. THE FACT IF YOU GIVE THEM A SAME FORM THE SECOND TIME, THEY DON'T RESPONSE, THAT SHOULDN'T OVERRIDE THE ORIGINAL NO. THE ONLY THING THAT SHOULD OVERRIDE THE ORIGINAL KNOW SHOULD BE IF THEY SAY YES TO A SECOND FORM. AS MARK NOTED, YOU CAN'T KEEP SENDING MULTIPLE TIMES, KEEP PRESSURING THEM -- >> UNTIL THEY DON'T NOTICE IT. >> THE FACT THEY DON'T NOTICE IT SHOULD BE MEANINGLESS BECAUSE YOU ALREADY HAVE AN ACTUAL RESPONSE FROM THEM >> I COMPLETELY AGREE WITH YOU. >> MARK'S TAKE. >> BUT I DON'T THINK THAT'S CLEAR IN THE DOCUMENTATION, THAT A FAILURE TO RESPOND TO A SECOND ATTEMPT TO OBTAIN CONSENT SHOULD NOT OVERRIDE AN INITIAL NO. >> I CAN PUT THAT IN THERE. THAT'S CERTAINLY NO DIFFERENT THAN WHAT WE BELIEVE, SO ... >> SO I'M GETTING TANGLED UP NOW IN THIS RESEARCHER WHO ISN'T ONE OF THE NAMED PARTIES CAN JUST COME IN AND GET A WAIVER, EVEN OF USE OF SPECIMENS THAT PEOPLE HAVE SAID NO. SO WHAT I'M THINKING IS IT WOULD HELP ME TO KNOW THAT THE IRB LOOKING AT -- WHEN RESEARCHER A COLLECTS A SPECIMEN FOR A PRIMARY STUDY FOR PEOPLE WHO HAVE SAID -- AND THEN YOU GOT A BUNCH OF PEOPLE WHO SAID NO, JUST USE IT FOR THE PRIMAR STUDY AND NOTHING ELSE, AND RESEARCHER B WASN'T NAMED AND COMES IN AND APPLIES FOR A WAIVER I WOULD OPEN THE IRB WOULD SAY, WAIT A SECOND, LET'S LOOK AT THE PAPER TRAIL HERE. RESEARCHER A WAS ABLE TO CONTACTS PEOPLE AND GOT YES AND NO AND NON-RESPONSES SO IT'S NOT GOING TO BE IMPRACTICABLE FOR RESEARCHER B TO ACTUALLY ASK THOSE PEOPLE WHO SAID NO. I HOPE THAT THAT WOULD HAPPEN, AND THAT THAT WOULD PROTECT US FROM HAVING NO HAVE VERY, VERY LITTLE MEANING. DOES THAT MAKE SENSE? >> I THINK LIMITED IRB REVIEW -- WE HAVE SOMETHING LATER IN THE DOCUMENT ABOUT THE QUALITY OF THE LIMITED IRB REVIEW. SO ONE OF THE THINGS ONE WOULD LOOK AT I THINK IN THE IRB REVIEW WOULD BE, YOU KNOW, WHAT WAS THE CONTEXT IN THIS WHICH BROAD CONSENT WAS EITHER GRANTED OR DENIED AND THEN HOLLY WANTED TO -- >> SORRY, I THOUGHT NANCY'S EXAMPLE FOR RESEARCHER B THERE WOULDN'T BE LIMITED IRB REVIEW. THEY WOULD BE SEEKING A WAIVER OF CONSENT. >> OH, RIGHT. YES, YOU'RE RIGHT. >> SO YOU'RE TRYING TO FIGURE OUT WHETHER IT'S PRACTICABLE FOR THEM TO OBTAIN CONSENT. AND I DON'T KNOW THAT WE CAN ASSUME BECAUSE RESEARCHER A HAD AN ANSWER THAT YOU'RE ABLE TO GO BACK TO THOSE INDIVIDUALS AND THAT IT WOULD BE PRACTICABLE IN THAT SCENARIO BUT IT DOESN'T BOTHER ME RESEARCHER B CAN GET A WAIVER BECAUSE DEPENDING ON THE WAY THE BROAD CONSENT FORM WAS WRITTEN, IT WOULD HAVE BEEN ALL ABOUT RESEARCHER A AND RESEARCHER A'S TEAM, RIGHT? SO THE NO WAS I DON'T WANT RESEARCHER A TO BE ABLE TO DO THESE THINGS. THE NO HAD NOTHING TO DO WITH RESEARCHER B. RIGHT? AND YOU CAN IMAGINE A PATIENT SAYING, YOU KNOW, I HATE RESEARCHER A, I DON'T WANT THEM TO TOUCH ANYTHING OF MINE BUT THEY MAY HAVE NO GENERALIZED VIEWS ABOUT BIOSPECIMEN RESEARCH OR HOW DATA IS USED. THEY COULD BE TOTALLY FINE WITH RESEARCHER B OR C OR D, USING THAT INFORMATION. I DON'T THINK WE SHOULD CONFLATE A NO FOR A SPECIFIC PERSON AND SPECIFIC PURPOSE TO OTHERS. I THINK THAT'S KIND OF THE REASON WE'VE BEEN SO -- WHY IT'S IMPORTANT TO BE SO SPECIFIC ABOUT WHAT THE BROAD CONSENT TEMPLATE SAYS. >> NO, I AGREE WITH YOU COMPLETELY. I JUST -- WHAT I'M JUST HOPING THE IRB IS ACTUALLY GOING TO BE THINKING THAT WAY THAT IT MIGHT HAVE TO DO WITH PARTICULAR RESEARCHERS OR PARTICULAR TYPES OF RESEARCH AND THE LOOK INTO THAT WAIVER SHOULD TAKE INTO ACCOUNT ALL OF THESE FACTORS. AND IF IT DOES, IF IT DOES, THEN THE IRB CAN SAY, YES, IT IS IMPRACTICABLE AND WE'LL GRANT THE WAIVER IN THIS INSTANCE OR SAY WE MIGHT HAVE TOO MANY QUESTIONS ABOUT THE NATURE OF THAT NO AND DON'T THINK IT'S IMPRACTICABLE AS RESEARCHER B. I WANT THE IRB TO TAKE THAT COMPREHENSIVE A LOOK SO THAT THE NO DOESN'T BECOME ESSENTIALLY MEANINGLESS. >> I WONDER AS A PRACTICAL MATTER WHETHER RESEARCHER B WOULD HAVE ANY WAY OF KNOWING THAT RESEARCHER A HAD ASKED FOR CONSENT, RIGHT? OR ARE YOU THINKING THE IRB WOULD HAVE HAD THINGS ON FILE SO THEY WOULD SAY, OKAY, THIS SPECIMEN RESEARCHER B WANTS WAS OBTAINED IN THIS OTHER RESEARCHER A DID AND SO WE'RE GOING TO LOOK THROUGH OUR FILES BECAUSE RESEARCHER B MIGHT HAVE NO IDEA, SO IN TERMS OF WHAT THEIR APPLICATION SAYS THEY MIGHT NOT BE ABLE TO ARTICULATE ONE CONSENT WAS PROVIDED OR REFUSED. >> RIGHT. BUT IF RESEARCHER B SAYS I WANT ACCESS TO RESEARCHER'S A'S SPECIMENS, THEN THAT'S GOING TO BE CONNECTED IN SOME WAY. BUT I UNDERSTAND THE DIFFICULTY. ALL I'M SAYING IS I WANT TO BE REASSURED THAT THE IRB IS GOING TO BE THINKING THROUGH IT IN THIS WAY RATHER THAN JUST SAYING, OH, YEAH, WE CAN GRANT A WAIVER. >> I THINK IT'S GOING TO BE VERY -- THERE MAY BE MANY INSTANCES WHERE TRULY IT IS IMPRACTICABLE, THE TIME PASSED WAY TOO GREAT. GIVEN THE STRUGGLE WE'RE HAVING UNDERSTANDING CONSTRAINTS PLACED AROUND EITHER THE AGREEMENT OR THE REFUSAL OR LIMITATIONS I CAN'T FATHOM HOW A PARTICIPANT WILL BE ABLE TO DO IT AND HOW WE EXPLAIN IN A DOCUMENT SO THEY UNDERSTAND THE LIMITATION ON USE OF SPECIMEN OR LIMITATION OF REFUSAL. IT'S GOING TO BE EXCEPTIONALLY DIFFICULT IF NOT IMPOSSIBLE. >> I SECOND THAT. I THINK IT'S NOT NECESSARILY FOR MOST SUBJECTS GOING TO BE VERY MEANINGFUL WHO IS THE PERSON WHO IS GRANTED THE USE OF THAT SPECIMEN. SOME SUBJECTS WILL HAVE STRONG FEELINGS, POSITIVE OR NEGATIVE. I DON'T WANT THIS PERSON, I WANT THIS PERSON. FOR THE VAST MAJORITY I SUSPECT IT WILL BE SOMEBODY'S USING MY TISSUE, AND THAT'S GOING TO BE THE PROBLEM. THE OTHER ISSUE IS OVERALL. IT'S NOT THE FAULT OF HOW THE GUIDANCE IS WRITTEN. I THINK IT'S JUST THE NATURE OF THE REGULATIONS. IT FEELS AS IF IT IS DECEPTIVE OR DISHONEST ALMOST THAT WE'RE ASKING FOR YOUR CONSENT BUT AT THE END OF THE DAY IF YOU DON'T GIVE YOUR CONSENT WE CAN TAKE ALL YOUR TISSUE, DEIDENTIFY IT AND USE IT ANYWAY. THAT DOES NOT FEEL LIKE IT'S RESPECTFUL OF SUBJECTS. I DON'T KNOW IF THERE'S A WAY TO WORK AROUND THAT BUT THAT WOULD BE THE CASE THAT I WOULD BE AFRAID PEOPLE WOULD WALK AWAY WITH. >> WE'RE GOING TO GET I THINK TO THE TEMPLATE CONSENT AT SOME POINT. AND YOU'LL SEE THAT WE'RE ALL UNCOMFORTABLE WITH THAT I THINK. YOU KNOW, ACTUALLY MAKING THAT EXPLICIT MAKES EVERYBODY UNCOMFORTABLE BECAUSE IT'S SORT OF A -- AND I THINK FOR THOSE WHO PARTICIPATED IN WRITING THE TEMPLATE, THEY ACTUALLY TOOK THIS AS AN OPPORTUNITY TO EDUCATE PEOPLE, THIS IS THE REALITY. WE KNOW WHEN PEOPLE FIND OUT THIS IS HOW IT GOES NOW, PEOPLE GOING TO WAIVER AND USE THEIR STUFF, IT'S NOT -- SOME PEOPLE DON'T CARE, SOME PEOPLE DO. THIS WILL MAKE THAT VERY OBVIOUS TO PEOPLE. BUT THAT IS THE REALITY. I'M NOT SURE, YOU KNOW, THE NPRM TRIED TO CHANGE THAT. THAT'S NOT WHAT WE'RE DEALING WITH. >> THE PROBLEM JUST TO REITERATE THAT, THE PROBLEM IS THAT IS NOT THE VALUE CHOICE THAT WAS MADE IN THESE DOCUMENTS. THAT'S ACTUALLY WHAT THE REGULATION SAYS. SO THE DOCUMENT THEREFORE HAS TO BE CONSISTENT WITH THE ACTUAL EXPLICIT REGULATIONS. THAT'S THE DIFFICULTY. OKAY. MOVING ON. LET'S SEE. THIS IS THE CONSEQUENCES. OH, THIS IS DESCRIBING IN PRINCIPLED FORM WHAT WE THOUGHT OUGHT TO BE IN A BROAD CONSENT. BASICALLY MAKING CLEAR IF YOU SAY YES, THIS HAPPENS. IF YOU SAY NO, THIS HAPPENS. IF YOU DON'T SAY YES OR NO, THIS IS WHAT THE EFFECT IS. WE'RE ENDORSING IT AS GUIDANCE. THIS IS NOT THE ACTUAL LANGUAGE OF TEMPLATE OR ENDORSING THE IDEA THE CONSEQUENCES OF A DECISION WHEN OFFERED A BROAD CONSENT WOULD BE -- OUGHT TO BE EXPLICIT IN THE ACTUAL BROAD -- THE ACTUAL BROAD CONSENT. >> MARK, I FOUND THIS PART CONFUSING BECAUSE I THINK PEOPLE MIGHT THINK THIS IS TEMPLATE LANGUAGE, EVEN THOUGH OBVIOUSLY WE HAVE THE OTHER TEMPLATE AT THE BACK END WHICH SAYS IF YOU SAY YES TO THIS, YOU SAY NO WHAT IT MEANS. ARE YOU OPPOSED TO TAKING THE -- >> I DON'T MIND TAKING THIS OUT AND SHORTENING INTO THREE SHORT BULLET POINTS. >> YEAH, I THINK THAT WOULD BE EASIER. >> I THINK THIS IS WHAT WE WERE TALKING ABOUT EARLIER, THE TEMPLATES ADVANCED BEYOND THIS, YEAH. OKAY, I CAN DO THAT. SPECIFICITY OF FUTURE USES, THIS IS BASICALLY TALKING ABOUT THE ISSUE OF THE VARIOUS STATE REGULATIONS AND OTHER FEDERAL REGULATIONS THAT REQUIRE THAT CERTAIN SPECIFIC USES, FUTURE USES OF IDENTIFIABLE DATA AND CALLED OUT. CONTINUING RESEARCH AFTER BROAD CONSENT. THESE ARE -- THEN THE DEFINITION OF THE LIMITED -- WHAT THE LIMITED IRB REVIEW OUGHT TO CONSIST OF. >> GO BACK TO WITHDRAWAL, IT FOLLOWS THE COMMENT. THIS IS ONE OF THE PLACES I'VE HAD TROUBLE, HAVING SEEN IT BEFORE IN OTHER CONTEXTS. I THINK IT'S A LITTLE BIT DIFFERENT TO THEN JUST DEIDENTIFYING GENERALLY. IN THE TEMPLATE I REALLY LIKE THAT AT LEAST WE'RE TALKING ABOUT IT AND LETTING PEOPLE KNOW. THE IDEA SOMEONE COULD TAKE THE TIME TO SAYIVE CONSENTED BEFORE AND THOUGHT ABOUT IT DIFFERENTLY AND I DON'T WANT YOU TO USE MY MATERIALS ANYMORE THAT WE CAN WITH THAT JUST GO AHEAD AND USE THEIR MATERIAL, DE-IDENTIFIED, I THINK IS REALLY DISRESPECTFUL. I HAVE NO PROBLEM WITH ALSO AT THAT POINT SAYING WOULD IT BE OKAY TO CONTINUE TO USE IT IN A DE-IDENTIFIED MANNER, TO WHICH SOME PEOPLE MIGHT SAY YES, OTHER PEOPLE MIGHT SAY NO. I RECOGNIZE THE CHALLENGES HERE BUT FOR SOMEBODY TO COME BACK AND SAY I CHANGED MY MIND, AND THEN TO CONTINUE TO USE THEIR MATERIALS I THINK IS NOT CONSISTENT WITH WHAT THEY WOULD HAVE EXPECTED TO HAPPEN IF THEY WITHDREW THEIR CONSENT. >> TELL YOU WHAT WE CAN DO. I MEAN, THE PROBLEM IS THAT'S NOT WHAT THE REGULATION SAYS. RIGHT? SO -- >> AND CAN YOU POINT ME TO WHERE -- I MEAN, I'M VERY CLEAR THAT IT SAYS YOU CAN USE THE DE-IDENTIFIED. BUT IF YOU CAN POINT ME TO WHERE IT SAYS AFTER SOMEBODY WITHDRAWS -- >> I'LL HAVE TO LOOK FOR IT. I DON'T HAVE IT WITH ME. I CAN LOOK FOR IT OVERNIGHT, I DON'T KNOW IF IT'S ARE THE REGULATION, GUIDANCE, COMMENTARY. >> IT MAY BE BURIED ABOUT THERE BECAUSE I'VE BEEN LOOKING FOR IT. >> I'LL LOOK FOR IT BUT IT DOES SAY THAT. ONE ALTERNATIVE HERE IS WE COULD DROP A FOOTNOTE AND BE CLEAR BECAUSE THE RULE ALLOWS IT DOESN'T MEAN AN INTUITION HAS TO ALLOW IT. AN INSTITUTION MIGHT DECIDE WHEN THERE'S AN ACTUAL WITHDRAWAL, WITHDRAWAL IS AMBIGUOUS AS TO FUTURE USE OF IDENTIFIABLE DATA, OF THE DE-IDENTIFIED DATA AND DE-IDENTIFIED BIOSPECIMENS, THAT OUGHT TO BE -- I THINK IT'S A PROBLEM ABOUT THE FUTURE USE OF THE IDENTIFIABLE INFORMATION -- OF THE FUTURE USE OF THE DEIDENTIFY IDENTIFIED INFORMATION, BECAUSE SOME INFORMATION ABSOLUTELY HAS TO BE USED FOR OTHER -- IN A DE-IDENTIFIED FASHION FOR OTHER PURPOSES LIKE FOR UTILIZATION REVIEW. IT'S LIKE THAT IS -- THE HORSE IS WAY OUT OF THE BARN ON THAT ONE BUT IN TERMS OF DE-IDENTIFIED SPECIMEN AFTER THE UNAMBIGUOUS DECLARATION I DON'T WANT YOU TO USE MY SPECIMEN, WE COULD PUT THAT IN. >> I'M READING SACHRP RECOMMENDS, THAT'S SOMETHING I FIND TROUBLING. >> I DON'T REMEMBER, WHETHER IT'S JOINT GUIDANCE ON WITHDRAWAL OF BIOSPECIMENS WITH FDA, THERE WAS A DISCUSSION THERE ABOUT DIFFERING RULES, FDA REQUIRES YOU HAVE TO KEEP THE DATA AND THAT SORT OF STUFF, THERE WAS A SEPARATE DISCUSSION FOR STUFF NOT COVERED UNDER FDA'S RULES, THAT MAY BE LANGUAGE THAT COULD BE INSERTED HERE, IF THE RESEARCHER -- YOU KNOW, IT WOULD NOT BE PROBLEMATIC, FOR EXAMPLE, SOCIAL BEHAVIOR RESEARCHER, NOT A BIG DEAL OUT OF A THOUSAND SUBJECTS THAT 20 OF THEM OR 50 OF THEM, WHATEVER IT IS, DON'T WANT THEIR DATA USED AT A CERTAIN POINT FOR WHATEVER REASON, IF THAT'S PERFECTLY ACCEPTABLE, AS A SCIENTIFIC AND OTHER MATTER, IT INDICATES AS LONG AS YOU'RE NOT UNDER THE FDA RULES RESEARCHER CERTAINLY SHOULD TRY TO DO WHAT THE SUBJECT WANTS IF IT'S NOT GOING TO HARM THE RESULTS OF THE STUDY. IT MAY BE A CONSENT YOU COULD SORT OF LINK OR GLOM ON TO HERE IN SOME WAY OR ANOTHER. >> THE CONTINUING USE MAKES SENSE. AGAIN, THAT'S PART OF WHAT THE TEMPLATE AND CONSENT LANGUAGE HAS SAID. YOU KNOW, IF YOU WITHDRAW AND IT'S ALREADY BEEN IN USE, ALREADY IN A STUDY, WE'RE GOING TO FINISH THAT. IT'S WHAT WE'RE GOING TO DO WITH IT IN THE FUTURE. >> TO CLARIFY I THINK THE RULE HAS TO DO WITH PRIMARY RESEARCH WHEN SOMEONE WITHDRAWS FROM THE RESEARCH, AND FDA'S POLICY IS THAT ANY PREVIOUSLY COLLECTED DATA IS RETAINED BUT SUBSEQUENT DATA THEREAFTER IS NO LONGER USED. >> JUST POINTING OUT. SO IT'S GOING A LITTLE FURTHER THAN LESLIE IS EVEN SUGGESTING BUT EVEN IF IT'S IN THE REAL STUDY, IF A SUBJECT BASICALLY SAYS THEY WANT THE DATA TAKEN OUT AT SOME POINT OR DON'T WANT ANY FURTHER USE, FOR EXAMPLE, BIOSPECIMENS, FDA IF YOU COLLECT AND YOU'RE ALREADY USING IT IN A STUDY YOU HAVE THAT PERSON ALREADY AS A SUBJECT, THAT AFFECTS THE SCIENCE FOR THEM TO NOT ALLOW FURTHER RESEARCH USE OF THE BIOSPECIMENS, WE WERE JUST NOTING AS A SCIENTIFIC MATTER IF IT'S ACCEPTABLE TO ALLOW RESPECT FOR WHAT THE SUBJECT WANTS ON OUR END IN YOU'RE NOT UNDER FDA JURISDICTION WE SUGGEST TO THE RESEARCHER TRY TO ACCOMMODATE WHAT THE SUBJECT WANTS TO THE EXTENT THAT'S NOT GOING TO ACTUALLY BE DETRIMENTAL, EVEN TO AN EXISTING RESEARCH STUDY. EVEN MORE SO IF THERE ISN'T AN EXISTING RESEARCH STUDY. IT'S INDICATING A SIMILAR THING IN OTHER GUIDANCE DOCUMENTS. IF IT'S NOT HARMFUL TO ANYTHING YOU COULD SUR AS A RECOMMENDATION DOING WHAT THE SUBJECT WANTS. >> I'LL NOTE IN THE PREAMBLE, IN THE DISCUSSION OF DIFFERENCE BETWEEN NPRM AND FINAL RULE THERE'S A DISCUSSION OF BROAD CONSENT, PROPOSED ELEMENT IN THE NPRM REQUIRED A SUBJECT MAY CAN DRAW CONSENT IF FEASIBLE FOR RESEARCH OR DISTRIBUTION, BLAH BLAH BLAH. INFORMATION STRIPPED OF IDENTIFIERS MAY NOT BE TRACEABLE AND MAY NOT BE FEASIBLE TO WITHDRAW. IF AN INVESTIGATORS PERMITTED DISCONTINUATION OF SUCH USE IT WAS EXPECTED THE INVESTIGATOR WOULD HONOR THIS COMMITMENT BY NOT STRIPPING IDENTIFIERS, USING THE INFORMATION OR BIOSPECIMENS IN RESEARCH. THE PROPOSED REGULATIONS WOULD NOT REQUIRE THE INVESTIGATORS TO MAKE SUCH A COMMITMENT. BUT SO LATER ON, PAGE 315, AS DISCUSSED IN THE NPRM, STRIPPED OF IDENTIFIERS MAY NOT BE TRACEABLE AND THUS NOT FEASIBLE TO WITHDRAW, IF AN INVESTIGATORS -- DISCONTINUED USE OF SUBJECT'S IDENTIFIABLE BIOSPECIMENS, THE CONTEXT WE'RE TALKING ABOUT NOW, IT IS EXPECTED THAT THE INVESTIGATOR WILL HONOR THIS COMMITMENT BY NOT REMOVING IDENTIFIERS. >> BY NOT WHAT? >> BY NOT REMOVING IDENTIFIERS. NOT INTENTION INTENTIONALLY. IF YOU REMOVED THEM BEFORE IT BECOMES UNTRACEABLE.& IF SOMEONE WITHDRAWS, A RESPONSE TO THAT, IF YOU REMOVE IDENTIFIERS SO YOU CAN CONTINUE USING THE STUFF IN RESPONSE TO A WITHDRAWAL, AT LEAST THIS LANGUAGE SUGGESTS THAT'S NOT WHAT WAS ENVISAGED, EVEN IF IT'S POSSIBLE, UNDER THE REGULATION. >> READ THE FIRST PART OF THAT SENTENCE AGAIN BECAUSE IT SOUNDED LIKE THE FIRST PART WAS CONDITIONAL, IF YOU LET PEOPLE >> THE PROVISION IS THE ELEMENT OF CONSENT THAT RELATES TO EITHER INFORMING, BASICALLY NOTICE THAT YOU WERE TELLING PEOPLE THAT WE COULD USE YOUR BIOSPECIMENS OR DATA IN A DE-IDENTIFIED WAY, OR THE OPTION WAS TO COMMIT TO NOT DOING THAT IN WHICH CASE YOU WOULD HAVE TO HONOR THE COMMITMENT. IS THAT THE -- >> RIGHT. >> SOUNDS LIKE THE PROVISION WE'RE TALKING ABOUT. IN OTHER WORDS THE GENERAL PROVISION IN CONSENT FORMS GOING FORWARD IS PROBABLY, GETTING BACK TO THE TOPIC WE TALKED ABOUT EARLIER, TO LET PEOPLE KNOW ABOUT AN ASPECT OF THE RULES THAT PEOPLE ARE UNCOMFORTABLE ABOUT, THAT NAMELY, YOU KNOW, IF WE END UP HAVING IDENTIFIABLE STUFF RELATING TO YOU, WE COULD ALWAYS DEIDENTIFY IT AND DO RESEARCH GOING FORWARD. BASICALLY THAT IS AN AVAILABLE OPTION, NOT EVEN SOMETHING THAT THE SUBJECT COULD OBJECT TO OR -- THEY COULD CERTAINLY NEGOTIATE WITH THE RESEARCHER BUT OTHER THAN BEING NOTIFIED ABOUT THIS AND DECIDING I DON'T WANT TO GO INTO THIS STUDY IT'S NOW ALLOWING TO BASICALLY PUT THE PERSON ON NOTICE AND SAYING THIS IS THE WAY THE RULES WORK, JUST AS IF -- WE'RE TALKING ABOUT A RESEARCH STUDY HERE, IT COULD HAVE BEEN CLINICALLY COLLECTED DATA OR BIOSPECIMENS WHICH THE RULES DO ALLOW RESEARCHERS TO ACCESS AND USE THEM IN A DE-IDENTIFIED WAY, THIS IS A VERSION OF THAT IN A RESEARCH STUDY. AS POLICY MATTER PEOPLE COULD HAVE GONE DIFFERENT WAYS IN THAT BUT THE RULES DO BASICALLY ALLOW THIS AS NOTICE, TO LET PEOPLE KNOW THIS IS THE WAY WE AS A COLLECTIVE USE BIOSPECIMENS AND DATA TO BENEFIT PEOPLE. WE'VE ELIMINATED THE PRIVACY CONCERNS. BUT WE WILL BENEFIT FROM IT NOW THAT WE'VE GOTTEN RID OF THE CONCERN. >> IT'S FINE IF THAT'S THE INTENT FROM THE BEGINNING. THE LANGUAGE HERE, SACHRP RECOMMENDS AN INDIVIDUAL GIVES CONSENT BUT LATER WITHDRAWS IS INVESTIGATORS MAY CONTINUE TO USE -- WE'RE ENCOURAGING STRIPPING OF IDENTIFIERS. WHETHER THAT'S APPROPRIATE, UNDER, YOU KNOW, IF THE PURPOSE OF THE STRIPPING IS BECAUSE SOMEONE SAID NO, THAT SEEMS SUSPECT. ETHICALLY SUSPECT. CLEARLY THEY ARE NOT GOING TO BE OUT OF COMPLIANCE BUT MAYBE WE SHOULD MAKE THAT A STATEMENT OF BEST PRACTICE AS OPPOSED TO. -- TO WHAT'S THERE. >> LET ME WORK WITH THIS THIS EVENING AND COME BACK TO YOU TOMORROW. I UNDERSTAND. OKAY. LIMITED IRB REVIEW. FOOTNOTE 16, TO BACK UP FOR A SECOND, THE FDA CONCERN IS PUT THERE ABOUT WHAT HAPPENS TO THE IDENTIFIABLE STUFF AFTER WITHDRAWAL. OKAY. LOOK ON PAGE 13, THE PARAGRAPH THAT BEGINS FINALLY AN IRB. POINT OUT SOMETHING THAT WAS DIFFERENT THAN THE VERSION YOU SAW BEFORE. THAT'S IMPORTANT. IF YOU LOOK ON THE BOTTOM OF PAGE 13, AN IRB IN LIMITED REVIEW WOULD OPTIMALLY ASSURE PROPOSED RESEARCH WOULD NOT BE FUNDAMENTALLY SHOCKING TO OR FUNDAMENTALLY INCONSISTENT WITH PREVAILING COMMUNITY ATTITUDES AMONG THOSE WHO HAVE GIVEN THEIR BROAD CONSENT, SUCH A ROLE FOR THE IRB IS NOT REQUIRED OR DIRECTED BY THE FINAL RULE, INSTITUTIONS MAY APPLY STANDARDS OF APPROPRIATENESS, THIS IS AN ATTEMPT TO EMPOWER IRBs IN A LIMITED REVIEW TO BE ABLE IN EXTREME SITUATIONS TO SAY NO DESPITE THE FACT THE EXEMPTION AS A PURELY LEGAL MATTER WOULD BE AVAILABLE TO THE RESEARCHER WE DISCUSSED THIS AT SOME POINT. >> TO PROVIDE CONTEXT, THIS CAME UP IN THE LAST MEETING, AND PEOPLE WERE -- PEOPLE WERE ABLE TO CREATE CASES PEOPLE THEY FELT WOULD BE SHOCKING TO PARTICULAR POPULATIONS WERE SUBSUMED IN THE BROADER DESCRIPTIONS OF FUTURE RESEARCH IN THE BROAD CONSENT AND THEY JUST WANTED SOME CHECK ON THAT. SO THAT WAS I THINK WHAT THIS IS RESPONSIVE TO. >> RIGHT. THAT'S RIGHT. WE ALSO SAY IN THERE RESEARCHERS THEMSELVES ALSO HAVE THIS RESPONSIBILITY. IT'S NOT JUST THE IRB THAT HAS THE RESPONSIBILITY. MAYBE OBVIOUS BUT SOMETIMES NOT SO OBVIOUS. THE RETURN OF RESEARCH RESULTS GOES THROUGH THE -- WHAT I SAID BEFORE IN REGARD TO RETURN OF GENERAL OR AGGREGATE RESULTS, NOT VIOLATING -- IF YOU HAVE A PLAN TO RETURN GENERAL RESULTS THAT DOES NOT VIOLATE THE RETURN OF RESULTS THAT -- PRINCIPLE THAT WOULD NOT ALLOW YOU TO HAVE ACCESS TO THE EXEMPTION, AND THEN ALSO THE INCIDENTAL FINDINGS WOULD BE ALLOWED, IF THEY ARE TRULY INCIDENTAL. IF THE WHOLE GENOME SEQUENCING IF YOU DO INTEND TO RETURN ALL OF THESE FINDINGS, THEN THAT WOULD TAKE YOU OUT OF THIS EXEMPTION. REID? I WOULD SAY LIMITED IRB REVIEW WOULD SAY TO THE RESEARCHER WHO WANTS TO DO WHOLE GENOME SEQUENCING ARE YOU EXPECTING TO RETURN RESULTS? IF THE ANSWER IS I'M GOING TO FIND THINGS, I HAVE TO RETURN THEM, THE ANSWER IS YOU CAN'T HAVE THIS EXEMPTION. OKAY. >> JUST A MINOR POINT ON THIS ONE, THAT SENTENCE ON THE EXEMPTION IF NOT AVAILABLE PROPOSED RESEARCH WOULD BE SUBJECT TO FULL IRB REVIEW. >> I'M SORRY, WHAT SENTENCE? >> ON LINE 560. >> TELL ME WHAT PARAGRAPH YOU'RE ON. >> THE FIRST PARAGRAPH UNDER RETURN OF RESULTS. >> OKAY, HOLD ON. >> ABOUT HALFWAY DOWN. >> YEAH, OKAY. >> I THINK IT'S UNDER EXPEDITED REVIEW BASED ON OUR CONVERSATION, UNDER WHAT'S NOW 13. SO IT'S NOT EXEMPTION BUT I DON'T THINK IT HAS TO GO TO FULL BOARD. UNDER THE LIST WE'RE TALKING ABOUT, IF THAT MAKES SENSE. >> THEY MAY NOT BE REFERRING TO FULL -- TO COMMITTEE, FULL COMMITTEE IRB REVIEW. THEY ARE MAKING A DISTINCTION BETWEEN LIMITED IRB AND FULL IRB REVIEW. >> GOTCHA. >> EXACTLY. >> IT'S CONFUSING. WE DO HAVE THAT TERM THAT WE USE. >> RIGHT, RIGHT. YEP. I CAN REPLACE THE WORD "FULL" WITH "REGULAR" I GUESS. >> SOMETHING. BECAUSE-- >> NON-LIMITED. >> OTHER PEOPLE MIGHT GO IN MY DIRECTION. >> OKAY. EFFECT OF THE NON-REGULATORY BROAD CONSENT. WHICH I MIGHT LOOK AT IN LIGHT OF THE CONVERSATION TODAY, WHAT JERRY HAS SAID. I WILL LOOK AT THAT OVERNIGHT. AND THEN THE USE OF THE COMBINED FORM, WHICH WE HAD ALSO TALKED ABOUT. AND THAT IS THE -- THAT'S THE DRAFT GUIDANCE. STEPHEN, WE'RE ALMOST OUT OF TIME. WE HAVEN'T GOTTEN TO THE TEMPLATE YET. I DON'T KNOW WHAT YOU WANT TO DO . >> SO ARE WE AT THE END OF THIS ONE? >> YEAH. >> SO ANY LAST COMMENTS ON THIS? 3:30 TO 4:30 WAS RESERVED FOR THINGS COMING BACK. GIVEN EXTENT OF THE CHANGES MADE THIS MORNING I DON'T EXPECT WE'LL HAVE THE EXPEDITED REVIEW CATEGORIES COMING BACK. WHAT WE MIGHT HAVE -- WHAT WAS THE TOPIC? >> (INAUDIBLE). >> THANK YOU. [LAUGHTER] SO WE COULD DO ONE OF TWO THINGS. WE COULD GO AHEAD AND GO INTO THE BROAD CONSENT TEMPLATE, AND BRING THE BENIGN BEHAVIORAL BACK TOMORROW, BECAUSE WE DO HAVE TIME TOMORROW, OR WE CAN STOP AND LET PEOPLE DIGEST THE DISCUSSION ABOUT THE BROAD CONSENT AND BRING THE BENIGN BEHAVIORAL BACK NOW WHILE IT'S STILL FRESH. SO, MARK, TO SOME EXTENT, ANY THOUGHTS ON YOUR PART? >> IF YOU WANT ME TO KEEP GOING, I'M HAPPY BUT I NEED A SMALL BREAK. >> NO, NO. >> IF YOU WANT ME TO KEEP GOING. THAT'S THE ONLY THING I ASK. I'M HAPPY TO DO EITHER ONE. >> WHY DON'T WE TAKE A SMALL BREAK, AND THEN -- GENERALLY DO PEOPLE WANT TO KEEP GOING ON BROAD CONSENT? OKAY. THEN WE'LL COME BACK AND TRY TO GET THROUGH THIS. >> OKAY. IT MIGHT BE BETTER TO FINISH THE BROAD CONSENT. NOW YOU HAVE THESE CONTROVERSIES FRESH IN YOUR MIND. IT MIGHT BE EASIER TO UNDERSTAND THE TEMPLATE. >> OKAY, GOOD. LET'S COME BACK, BRIEF BREAK, LET'S COME BACK AT 3:30 AND START BACK UP AGAIN. >> LET'S GET STARTED AND JUMP INTO THE BROAD CONSENT TEMPLATE. THANK YOU, MARK. >> OKAY. OKAY. SO WHAT YOU HAVE IN FRONT OF YOU IS THE TEMPLATE WHICH IS NOT REQUIRED IN ORDER TO GET -- BUT THIS IS AN EXAMPLE OF WHAT ONE MIGHT USE. IT'S BEEN TAILORED TO SEVERAL SEVERAL MASTERS. IT'S SUPPOSED TO COMPLY WITH REQUIREMENTS FOR REGULATORY BROAD CONSENT. THE SECOND IS IT'S SUPPOSED TO FUNCTION AS A HIPAA AUTHORIZATION AS WELL. THE THIRD, TO FUNCTION MANY STATE REQUIREMENTS OF THE SPECIFIC USE OF IDENTIFIABLE DATA AND IDENTIFIABLE BIOSPECIMENS IN SPECIFIC SETS OF CIRCUMSTANCES LIKE MENTAL TESTING AND HYGIENE INFORMATION, TRYING TO DO SEVERAL DIFFERENT THINGS. IN SOME CASES LIKELY THINGS THAT YOU THINK ARE NOT -- THAT SEEM ODD, THAT'S BECAUSE THEY ARE TRYING TO MEET ONE OF THE OTHER SETS OF REQUIREMENTS. THE PROBLEM IS THAT YOU COULD DO A BROAD CONSENT BUT IF YOU'RE A HIPAA-COVERED ENTITY THE BROAD CONSENT ISN'T GOING TO BE EFFECTIVE UNLESS IT ALSO COMPLIES WITH HIPAA SO YOU HAVE TO GET A SECOND HIPAA CONSENT UNLESS YOU TRY TO PUT IT -- EMBED IT HERE. THAT IS PRESUMING, BY THE WAY, THAT -- AND I PRESUME THIS IS THE ANSWER, BUT OCR, I'M HOPING, WOULD REGARD - REMEMBER THERE'S A HIPAA RULE AGAINST COMPOUND AUTHORIZATIONS. I'M HOPING THAT OCR WOULD TAKE THE EXPECT, I'M EXPECTING THEY WOULD TAKE THE POSITION THE BROAD CONSENT IS ENOUGH OF A RESEARCH CONSENT THAT IT CAN BE COMBINED WITH HIPAA AUTHORIZATION BECAUSE OTHERWISE THE BROAD CONSENT WOULD REQUIRE A SEPARATE HIPAA AUTHORIZE WHICH WOULD NOT BE USEFUL, BUT ANYWAY THE JURY IS OUT ON THAT. I EXPECT THEY WOULD THINK THIS WAS AN ALLOWABLE COMPOUND AUTHORIZATION. OKAY. SO THERE IS A ONE-PAGE FORM THAT I DON'T HAVE UP HERE WHICH IS OUT ON THE TABLE WHICH DAVID STRAUSS FROM PSYCHIATRIC INSTITUTE IN NEW YORK HAD DRAFTED AS AN INTRODUCTION OR BROCHURE THAT COULD BE PUT ON TOP OF THIS BROAD CONSENT. I WOULD CALL YOUR ATTENTION TO THAT. WE DON'T NEED TO REVIEW THE LANGUAGE OF THAT BUT IF YOU DO HAVE -- >> (INAUDIBLE). >> THAT'S FINE. THAT DOCUMENT CAME LATE IN THE PROCESS. IT DID NOT GO THROUGH FULL SUBCOMMITTEE REVIEW. I EDITED IT. DAVID WROTE IT. AFTER A DISCUSSION, I EDITED SOMEWHAT SO IT WAS NOT INCONSISTENT WITH THE TEMPLATE, WITH THE DRAFT TEMPLATE. AND IT'S MEANT TO BE A POSSIBLE INTRODUCTION IN A BROCHURE OR INFORMATION SHEET FORMAT TO BE USED TO INTRODUCE THE IDEA OF THE BROAD CONSENT. BUT WE'RE NOT GOING OVER THAT BECAUSE IT'S NOT BEEN FULLY VETTED BY THE SUBCOMMITTEE. I WOULD ENCOURAGE YOU TO READ IT. IF YOU THINK THERE'S A PROBLEM WITH IT, A WORDING PROBLEM OR WHATEVER, TELL ME AND I CAN MAKE THOSE CHANGES. THIS IS THE TEMPLATE THAT'S BEEN OVER -- THAT'S BEEN REVIEWED AGAIN AND AGAIN AND AGAIN. WHAT WE TRIED TO DO IN THIS TEMPLATE IS TRIED TO MAKE IT A PODAGOGIC DEVICE TO TEACH PEOPLE WHAT THE RESEARCH IS ABOUT, WHY IT'S BENEFICIAL AND CONSEQUENCES IF YOU RESPOND YES, IF YOU RESPOND NO, AND IF YOU DON'T RESPOND AT ALL OR CHOOSE NOT TO ANSWER EITHER YES OR NO. WE TRIED TO BE QUITE EXPLICIT ABOUT THAT. SO IF YOU LOOK AT THE INTRODUCTION, THE INTRODUCTION STARTS WITH THIS IS WHAT RESEARCH WITH INFORMATION AND WITH PRIVATE INFORMATION AND BIOSPECIMENS IS FOR, THIS IS WHAT IT LOOKS LIKE. WE TRY TO IN THE SECOND PARAGRAPH, WE TRY TO IDENTIFY WHAT DE-IDENTIFIED MEANS AND FEDERAL LAW ALLOWS DE-IDENTIFIED INFORMATION AND DE-IDENTIFIED SPECIMENS TO BE USED WITHOUT OTHER KINDS OF SUPERVISION AND WITHOUT ASKING AN INDIVIDUAL FOR PERMISSION. THAT HAS NOT CHANGED. WE TRY TO MAKE IT CLEAR THAT'S NOT CHANGED BECAUSE OF THE BROAD CONSENT, THAT'S BEEN A PRINCIPLE FOR MANY YEARS. AND THEN WE TRY TO DEFINE WHAT IS IDENTIFIED AND IDENTIFIABLE AS OPPOSED TO DE-IDENTIFIED. AND THEN WE TRY AT THE BOTTOM IN THE THIRD PARAGRAPH AT THE BOTTOM OF IT TO EXPLAIN WHAT A BROAD CONSENT ACTUALLY IS. WHEN RESEARCHERS ASK YOU TO SAY YES TO ALLOW YOUR IDENTIFIABLE INFORMATION AND BIOSPECIMENS BE USED IN A WIDE RANGE, THIS IS BROAD CONSENT, AND THIS IS WHAT WE'RE ASKING YOU TO AGREE TO IN THIS FORM. I DID NOT EDIT THIS TO SAY IT IS WHAT -- IT IS THAT TO WHICH WE'RE ASKING YOU TO AGREE, BUT ANYWAY. BECAUSE WE WERE TRYING TO PRESERVEEL COLLOQUIALISM OF IT. THEN WE GO INTO WHAT WE'RE ASKING YOU TO DO. WHAT WE'RE ASKING YOU, AND IT SAYS BASICALLY WE SUMMARIZE ON THE TOP OF THE SECOND PAGE WHAT A YES MEANS, AND WHAT A NO MEANS. WE MAKE IT CLEAR THAT IT'S BETTER FOR YOU TO SAY YES OR TO SAY NO. STEPHEN, DID YOU WANT TO SAY SOMETHING? NO? THE-- WE STRESS AGAIN THAT THIS APPLIES ONLY TO IDENTIFIABLE INFORMATION, AND IDENTIFIABLE BIOSPECIMENS, NOT TO THE DE-IDENTIFIED. THEN THERE IS THE PURPOSE. SURE, GO AHEAD. >> REALLY MINOR BUT THROUGHOUT I THINK WE JUST WANTED TO USE CONSISTENT LANGUAGE, WHETHER WE WANT TO SAY IDENTIFIABLE INFORMATION, IDENTIFIABLE BIOSPECIMENS, AT EVERY JUNCTURE, BECAUSE SOMETIMES WE PUT IDENTIFIABLE IN FRONT OF ONE WORD, SOMETIMES IN FRONT OF BOTH WORDS. >> YEAH, I THOUGHT I HAD ACTUALLY PUT IT IN FRONT OF ALL WORDS BUT I MAY NOT HAVE. >> THIRD PARAGRAPH, PAGE 2, WE SAY YOUR IDENTIFIABLE INFORMATION AND BIOSPECIMENS. >> I'LL GO BACK. THE PROBLEM IS I THINK IT'S BETTER THAT WE PUT IDENTIFIABLE IN FRONT OF BOTH BECAUSE OF THE -- IF NO OTHER REASON BECAUSE OF THE CONFUSION OF ORIGINAL NPRM WHICH APPLIED TO BOTH DE-IDENTIFIED AND IDENTIFIED BIOSPECIMENS SO I'LL GO BACK AND CHECK THAT. OKAY. >> CAN I ASK A QUESTION? >> SURE. >> I GUESS IT'S PARTLY UNDER PURPOSE, BUT I'M CONFUSED ABOUT HOW PEOPLE ARE SUPPOSED TO TALK ABOUT THE LIMITATIONS OF THE BROAD CONSENT. CLEARLY WE'RE NOT TALKING ABOUT BROAD CONSENT. ANYBODY CAN DO ANYTHING. WE'RE TALKING ABOUT IT SOMEHOW BEING ATTACHED IN SOME WAY TO AN INSTITUTION OR SOME PART OF AN INSTITUTION. >> UH-HUH. >> WE'VE ALSO TALKED TODAY ABOUT IT BEING ATTACHED TO A RESEARCHER, OR SOME RESEARCHER'S PROGRAM OF RESEARCH. WE'VE TALKED ABOUT IT BEING ATTACHED TO A GENERAL TOPIC, OR A DISEASE, OR SOMETHING LIKE THAT. AND WE'VE ALSO TALKED ABOUT IT BEING LIMITED IN TERMS OF WHAT TYPES OF RESEARCH MAY BE DONE. WHETHER YOU CAN DO WHOLE GENOME SEQUENCING, FOR EXAMPLE, OR NOT. BUT THERE'S NO REAL GUIDANCE HERE TO HOW THIS -- THE LIMITATIONS OF THE BROAD CONSENT SHOULD BE DESCRIBED, WHAT THOSE PARAMETERS ARE, AND IT'S REALLY IMPORTANT BECAUSE IF IN A LIMITED IRB REVIEW THE IRB IS SUPPOSED TO DECIDE WHETHER THIS PROPOSED PIECE OF RESEARCH QUALIFIES FOR EXEMPTION BECAUSE IT'S PRETTY MUCH COVERED UNDER THE BROAD CONSENT, I DON'T SEE HOW THEY ARE SUPPOSED TO DO IT WITHOUT SOME SENSIBLE INFORMATION ABOUT WHAT IS ACTUALLY COVERED UNDER THE BROAD CONSENT AND WHAT MIGHT NOT BE. >> IF YOU LOOK AT THE WHAT TYPES OF RESEARCH MAY BE DONE, THEN IT GIVES YOU A LIST OF WHAT COULD BE DONE AND IT HAS INSTRUCTION, I HAVEN'T GOTTEN THERE YET BUT I THINK IT HAS INSTRUCTION ONE SHOULD EDIT THE LIST, EITHER PROACTIVELY TO TAKE THINGS OUT OR TO ADD THINGS, IF ONE THINKS THAT THERE ARE PARTICULAR CATEGORIES OF ACTIVITIES. >> WHERE DOES IT SAY TO DO THAT? >> WE'LL GET TO IT. >> OH. >> IT'S AFTER THE LIST OF -- >> THERE'S A REFERENCE TO STATE LAWS. >> I SAW IT. I SAW IT WHEN I READ IT. I'M NOT EXACTLY SURE WHERE. HOLD THAT. >> THAT'S FINE. >> OKAY. YEAH, IN THE PURPOSE OF THE BROAD CONSENT, THAT'S THE FIRST PLACE WE ASK YOU TO NAME THE CATEGORY OF PEOPLE OR INSTITUTION TO WHICH THE -- THAT WILL RUN IN FAVOR OF WHICH THE BROAD CONSENT WILL RUN, ESSENTIALLY. SO IT COULD BE THE NAME OF THE BIOREPOSITORY, DATA BANK, BIOBANK, INSTITUTION, THE DEPARTMENT WHICH IS MISSPELLED, OR THE DIVISION, OR IT COULD SAY A PARTICULAR TEAM OF RESEARCHES. THIS WHOLE FORM BY THE WAY, I MEAN, THIS IS NOT SCRIPTURE. THIS CAN BE EDITED BY ANYONE. IT'S SIMPLY TRYING TO SHOW -- TO BE AN ILLUSTRATION OF WHAT IT MIGHT LOOK LIKE, BUT ANY OF IT CAN BE EDITED AS LONG AS YOU HAVE THE REQUISITE 10 OR 11 ELEMENTS THAT ARE REQUIRED IN THE REGULATION. IN THE PURPOSE IT ALSO ASKS FOR IF YOU WANT TO PUT A TIME LIMIT ON IT, THERE ARE TIME LIMITS IN SOME OF THESE INSTITUTIONAL FRONT END CONSENTS, SOME DO HAVE TIME LIMITS. IN THE RESEARCH THAT CAN BE DONE, WE'RE TRYING TO -- ON ONE HAND REMEMBER THE GUIDANCE, RAFT GUIDANCE SAYS WE SHOULD NOT BE TOO SPECIFIC ABOUT THE KINDS OF STUFF THAT SHOULD BE DONE BECAUSE IF YOU'RE TOO SPECIFIC, IT MAY MEAN THAT YOU'RE EXPRESSING THINGS, THAT'S AN EXCLUSIVE LIST, NOT MEANT TO BE EXCLUSIVE, IF IT'S NOT MEANT TO BE A BROAD LIST, BUT YOU WANT TO GIVE PEOPLE FAIR NOTICE OF WHAT KINDS OF THINGS MIGHT BE DONE. AND THEN THERE ARE THE SPECIFIC USES THAT ARE REQUIRED BY THE FEDERAL LAW AND STATE LAWS AND SO YOU HAVE TO DO THAT. SO WHAT WE TRIED TO DO HERE IS DO A LITTLE BIT OF BOTH AND WE TALK IN THE POSSIBLE FUTURE RESEARCH MAY INCLUDE STUDYING CAUSES OF DIFFERENT DISEASES, DEVELOPING AND TESTING METHODS TO DIAGNOSE, WHOLE GENOME SEQUENCING WHICH IS REQUIRED IF YOU WANT TO DO IT THAT YOU HAVE TO SAY IT. SPECIFIC GENETIC RESEARCH WHICH IS CALLED OUT SEPARATELY FROM THE WHOLE GENOME SEQUENCING THEN THE CELL LINES AND CHIMERA ISSUES ARE PUT IN THERE BECAUSE WE THINK THAT MIGHT -- - IF YOU'RE GOING TO ALLOW YOUR RESERVERS TO DO IT UNDER BROAD CONSENT, IF YOU DON'T YOU CAN TAKE THIS OUT. THOSE ARE THE THINGS IF THERE ARE PLANS TO DO IT, MAY BE IMPORTANT ENOUGH TO SOME PEOPLE THAT THEY ACTUALLY OUGHT TO BE MENTIONED IN THE BROAD CONSENT. I'M GIVING YOU THE REASON BEHIND THIS LIST. AND THEN WHERE YOU START WITH THE DRUG ABUSE, ALCOHOLISM, MENTAL HEALTH, DEVELOPMENTAL DISABILITIES, ET CETERA, THOSE ARE THE THINGS THAT ARE REQUIRED BY THE STATE. BY STATE LAWS IN SOME CASES, IN MANY CASES. THAT'S WHERE THAT LIST COMES FROM. AND THEN RESULTS NOT PUT IN YOUR MEDICAL RECORD. LOOK AT THE PARAGRAPH BELOW WHERE IT SAYS RESULTS OF RESEARCH DONE, IDENTIFIABLE INFORMATION, WE ALSO -- IF THERE ARE THINGS THAT YOU WANT TO CARVE OUT THAT YOU WILL NOT ALLOW THE RESEARCHERS TO DO UNDER THE BROAD CONSENT, THEN THAT'S -- YOU SHOULD PUT THAT IN THERE, THAT WOULD BE A PLACE IN WHICH ONE COULD PUT THERE. IN TERMS OF RISK OF HARM, WE SAY THAT THE MAIN RISK IS YOUR PRIVACY COULD BE VIOLATED. AND THAT IS I GUESS THE MAIN RISK. EXCEPT THAT THE OTHER RISK IS RELATED DIGNITY HARM, WHICH IS IF YOU AGREE TO THIS, THEN IT'S POSSIBLE SOME FUTURE USES OF YOUR IDENTIFIABLE BIOSPECIMENS AND IDENTIFIABLE DATA MAY BE RESEARCH, THAT WOULD NOT -- THAT YOU WOULD NOT AGREE TO IF YOU WERE ASKED SPECIFICALLY ABOUT IT . THEN IT REFERENCES LIMITED IRB REVIEW WHICH WE CALL RESEARCH ETHICS COMMITTEE, WE'LL MAKE SURE THIS BROAD CONSENT COVERS RESEARCH STUDIES PLANNING TO USE IDENTIFIABLE INFORMATION FROM YOU. BOTTOM OF PAGE 3, THIS IS GOING INTO THE PRIVATE -- THE SPECIFIC PRIVACY ISSUES WHICH REALLY ARE ALLOWING THIS ALSO TO SERVE AS A HIPAA AUTHORIZATION FOR BROAD CONSENT, WHICH BY THE WAY CHRISTINA HYDIE WAS INSTRUMENTAL IN GETTING APPROVAL FOR 3 OR 4 YEARS AGO AT THE RECOMMENDATION OF THE COMMITTEE IN THE REVISIONS TO HIPAA. THESE THINGS ARE -- THESE ARE -- THIS IS A DUMBED DOWN -- AS DUMBED DOWN AS ONE CAN MAKE IT GIVEN REGULATORY REQUIREMENTS OF THE HIPAA -- OF THE REQUIREMENTS OF THINGS THAT MUST BE SAID IN A HIPAA AUTHORIZATION IN IN ORDER TO BE EFFECTIVE. IF YOU'RE NOT A HIPAA-COVERED ENTITY AND USING BROAD CONSENT WHICH IS GOING TO BE RARE AS A HEN'S TOOTH, BUT IF THAT IS THE CASE, YOU COULD EDIT THIS. AND IT COULD BE SHORTER AND BRIEFER AND MAYBE YOU WOULDN'T NEED IT AT ALL, THIS PARTICULAR SECTION. BUT THIS WAS MADE FOR -- DESIGNED FOR -- TO THE EXTENT THERE WILL BE A TYPICAL USE OF THE BROAD CONSENT, THIS IS WHAT WE TRIED TO CAPTURE. HIPAA IS WHY IT SAYS YOUR MEDICAL INFORMATION ONCE GIVEN TO PARTIES NOT BOUND BYLAWS SUCH AS HIPAA THAT PROTECT YOUR IDENTIFIABLE INFORMATION MAY NO LONGER BE PROTECTED UNDER THE HIPAA PRIVACY RULE. NO BENEFITS TO YOU PERSONALLY EXCEPT THAT YOU WOULD PARTICIPATE IN RESEARCH THAT MAY HELP OTHERS, MAY ADVANCE SCIENTIFIC KNOWLEDGE. IF YOU SAY NO, THIS IS A REQUIREMENT OF THE ALTERNATIVE TO BROAD CONSENT, THIS IS A REQUIRED STATEMENT UNDER THE ELEMENTS IN THE REGULATORY BROAD CONSENT. THAT IS IF YOU SAY NO YOU WON'T LOSE ACCESS TO HEALTH CARE OR OTHER BENEFITS TO WHICH YOU'RE ENTITLED, SAYING NO WILL NOT CHANGE YOUR RELATIONSHIP WITH YOUR HEALTH CARE PROVIDERS. IF THIS IS USED IN A SOCIAL SCIENCE SITUATION, SUBSTANCE ABUSE TREATMENT OR ANYTHING LIKE THAT, THEN ONE WOULD -- SMOKING CESSATION STUDIES, WHATEVER IT IS, YOU WOULD CRAFT IT APPROPRIATELY, THE LANGUAGE APPROPRIATELY. NOW, HERE, THIS IS IN BRACKETS, THIS IS ANTICIPATING A SITUATION THAT WAS ASKED ABOUT EARLIER IN WHICH THE BROAD CONSENT MAY ACTUALLY BE INTEGRATED WITH THE PRIMARY STUDY, SO BECAUSE THE DOWNSTREAM USE OF THE IDENTIFIABLE BIOSPECIMENS AND IDENTIFIABLE DATA IS SO CRUCIAL TO OVERALL RESEARCH AGENDA THAT IF YOU DON'T SIGN THE BROAD CONSENT YOU CAN'T PARTICIPATE IN THE PRIMARY STUDY. THAT WILL NOT BE THE TYPICAL CASE BUT MAY BE -- THAT BRACKET IS THERE AS AN OPTION. THEN THE CONSEQUENCES OF WITHDRAWAL, YOU CAN CHANGE YOUR MIND, IF YOU CHANGE YOUR MIND NO NEW RESEARCH USES. HOWEVER, WHAT WILL BE MADE, œHOWEVER IDENTIFIABLE OR ALREADY IN USE, GIVEN TO ANOTHER RESEARCHER MAY NOT BE DESTROYED, RETURNED, MAY CONTINUE TO BE USED IN STUDIES BEFORE YOU CHANGED YOUR MIND. YES? >> MARK, TAKE A MOMENT TO TALK MORE ABOUT THE NON-OPTIONAL -- YOU KNOW, INTEGRATION INTO ANOTHER STUDY WHERE THIS IS SO INTEGRAL TO THE SCIENTIFIC OUTCOME THAT IT'S NOT A CHOICE, NOT AN OPTION, BUT PARTICIPATION IS CONTINGENT ON GIVING THIS. WHAT IS SUCH A CIRCUMSTANCE? IT WAS RAISED IF THERE'S POTENTIAL THERAPEUTIC BENEFIT, IF THIS IS AN ONCOLOGY TRIAL, YOU KNOW, IT BECOMES POTENTIALLY COERCIVE, CERTAINLY UNDULY INFLUENTIAL IN TERMS OF BROUGHT CONSENT THROUGH USE GETTING TO THERAPEUTIC TRIALS, WHAT CIRCUMSTANCES DO YOU SEE THAT BEING USED? >> WELL, A COUPLE. ONE IS I MEAN IF IT IS A BANKING STUDY, OKAY, THAT'S ONE. THAT'S PROBABLY THE BIGGEST. ONE LARGE SET OF CIRCUMSTANCES. THE WHOLE PURPOSE -- YOU'RE SEEKING LUNG BIOPSY SPECIMENS FROM PEOPLE WITH CYSTIC FIBROSIS BECAUSE YOUR WHOLE TEAM AT THE CYSTIC FIBROSIS TEAM WANTS TO DO RESEARCH USING THAT STUFF. YOU'RE REPRESENTING WITH A WELL FUNDED FOUNDATION, SO -- AND THEY ARE AGREEING TO ALL OF IT. NOW, THE CHANCES ARE THEY WILL AGREE TO ALL OF IT BECAUSE IT'S A VERY ACTIVE AND PARTICIPATORY COMMUNITY THAT'S AFFECTED BY DISEASE. THAT'S ONE POSSIBILITY. ANOTHER POSSIBILITY AS I SAID BEFORE IS THE CONTEXT OF -- IN THE CONTEXT OF PERSONALIZED MEDICINE, FOR EXAMPLE THE CAR T THERAPY, TO GIVE AN EXAMPLE, IN THOSE SITUATIONS AS I UNDERSTAND IT, I'M NOT A PHYSICIAN, BUT AS I UNDERSTAND IT THE INTERVENTIONAL AGENTS ARE PERSONALIZED TO THE INDIVIDUAL. IT IS CRUCIAL, AS I UNDERSTAND IT, FOR FUTURE DEVELOPMENT, THE UNDERSTANDING THE EFFECTIVENESS AND SIDE EFFECTS OF THAT THERAPY THAT THOSE INDIVIDUALIZED SPECIMENS BE ABLE TO BE USED LATER DOWNSTREAM TO UNDERSTAND ALL OF THE EFFECTS AND SEQUENCES AND COMPARE THE EFFECTS ON ONE POPULATION TO THE EFFECTS ON ANOTHER POPULATION, IN, FOR EXAMPLE, IN CAR T THERAPY SOME STUFF IS MADE BY -- IT'S THE SAME DESIGN PROCESS BUT CAN BE MANUFACTURED BY DIFFERENT INSTITUTIONS, AND SO IT'S VERY IMPORTANT THEN TO BE ABLE TO STUDY DOWNSTREAM EFFECT OF ONE INSTITUTION'S BATCH VERSUS ANOTHER INSTITUTIONS BATCH. SO IT'S NOT JUST EFFECTIVENESS OF THE -- IT'S NOT JUST THE DATA THAT ARE GATHERED AND THE USE OF THE BIOSPECIMENS FOR THE PRIMARY STUDY. IT'S ALL SORTS OF FUTURE STUFF WITHOUT WHICH THERE IS -- IT MAKES THE PRIMARY STUDIES OF VERY LIMITED UTILITY UNLESS THERE IS THE DOWNSTREAM ABILITY TO USE. >> SO I WON'T GO -- I THINK THAT'S PROBABLY AN AREA THAT'S GOING TO BE ON A CASE-BY-CASE BASIS >> RIGHT. >> VERY MUCH SO. AND YOU KNOW, SO I DON'T KNOW, WE PROBABLY SHOULDN'T DISCUSS IT FURTHER. IT SEEMS TO ME YOU CAN PROBABLY SPECIFY ENOUGH OF THAT THAT IT REALLY DOESN'T SORT OF GET THE BROAD CONSENT THING, BUT MAYBE IT WOULD. I DON'T KNOW. JIM? >> YES, I WANT TO PUSH BACK A LITTLE BIT BECAUSE I THINK IF PEOPLE CONSENT TO BANKING OR TO AN INTERVENTIONAL STUDY, THEN THEY NEED TO BE TOLD WHAT THE EXPECTATIONS ARE FOR THEIR PARTICIPATION, AND THERE ARE STUDIES OBVIOUSLY INTEGRAL TO UNDERSTANDING THE INTERVENTION OR THE STUDY OF DISEASE, AND I HAVE NO PROBLEM WITH THE REQUIREMENTS OF PROVIDING BIOLOGICAL SAMPLES TO MEET THOSE EXPECTATIONS, BUT I AGREE WITH STEPHEN THAT MAKING CONSENT TO FUTURE UNSPECIFIED RESEARCH A REQUIREMENTS FOR ACCESS TO PRIMARY STUDY SHOULD ORDINARILY NOT BE ALLOWED. >> AND I EXPECT THAT WOULD BE THE DEFAULT POSITION UNLESS FACTS ARE VIEWED OTHERWISE. >> I THOUGHT -- I'LL GO BACK AND LOOK AT THE GUIDANCE, BUT I THOUGHT THAT WE HAD -- THAT WAS THE POSITION THAT WE HAD TAKEN IN THE GUIDANCE AS WELL. >> I THINK YOU SAY IN LIMITED CIRCUMSTANCES. I DON'T THINK IT'S EXTENSIVELY DESCRIBED. >> UH-HUH. >> AND OF COURSE IF YOU'RE DOING THIS UNDER EXEMPTION 7, D7, IT ONLY GOES THROUGH LIMITED IRB REVIEW. YOU KNOW, IF YOU'RE DOING A FULL STUDY, AND THIS IS AN ADD-ON, IT WOULD GO THROUGH FULL IRB REVIEW AND THEN THE THINK THE IRB WOULD BE WELL EQUIPPED TO ADDRESS THAT ISSUE. THAT'S WHAT WE DO ALL THE TIME. >> OKAY, CAN I READ THE LANGUAGE WE PUT INTO THE SPECIFIC ISSUE FROM THE GUIDANCE? STUDIES A BROAD CONSENT IF OFFERED SHOULD BE OFFERED ASSED ADJUNCT. THERE ARE STUDIES IN WHICH BIOSPECIMENS AND DATA ARE RECOGNIZED FROM OUTSET AS ESSENTIAL TO FUTURE STUDIES WITH THE COMPOUND OR AGENT TESTED IN WHICH A BROAD CONSENT IS SAY APPROPRIATELY REQUIRED IN ORDER TO ENROLL IN THE PRIMARY STUDY. SACHRP RECOMMENDS BROAD CONSENT BE ABLE TO BE COMBINED WITH CONSENT FORM FOR PRIMARY STUDY IN SAY APPROPRIATE CIRCUMSTANCES. THAT'S WHAT IT SAYS. THAT WAS THE RESULT OF THIS -- THIS IS A CONVERSATION THAT WE HAD HAD, SIMILAR TO CONVERSATIONS THAT WE HAD HAD. >> AS SOMEONE WHO SPENT THE EARLY PART OF HIS CAREER AT JOHNS HOPKINS, I KEEP THINKING WOULDN'T IT HAVE BEEN NICE IF WE HAD THIS AT THE TIME HENRIETTA LACKS WAS BEING MENTIONED. A POINT I WANT TO RAISE, MARK, A CERTAIN AMOUNT OF BIOREPOSITORY RESEARCH IS NOT MEDICAL. AND YET THIS DOCUMENT, IS HIGHLY MEDICAL. >> ABSOLUTELY. >> FACT THE WORD "PATIENT" IS USED. I WONDER IF WE WANT TWO SEPARATE DOCUMENTS OR BROADEN THIS TO MAKE IT MORE GENERIC. >> WELL, WE THOUGHT ABOUT IT. AND THE CONCERN WAS THAT WE ACTUALLY TRIED, AT THE BEGINNING I TRIED TO MAKE IT GENERIC, IT BECAME VERY CONFUSING AND UNWIELDY. SO WHAT OUR THOUGHT WAS, WAS TO GET THE TEMPLATE FOR BIOMEDICAL CONTEXT BUT WE HAD TO START WITH THIS. >> IN THIS EXAMPLE OF THE CAR T CELL THERAPY, YOU KNOW, AS A CANCER PATIENT I THINK, WOW, I UNDERGO THIS LEUKOPHORESIS AND COMPLEX MEDICAL PROCEDURE AND I'M BETTER, AND THEN I HAVE NO CONTROL OVER WHETHER MY BIOSPECIMENS GO TO MORE RESEARCH IN CAR T CELL OR IF THEY ARE GOING TO SOME OTHER RESEARCH IN SOME OTHER PART OF THE HOSPITAL THAT I'M NOT EVEN INTERESTED IN. RIGHT? I THINK THAT'S REALLY ADMITTEDLY -- THESE ARE THE PRO-ACTIVE PATIENTS WHO CARE ABOUT THESE THINGS BUT YOU HAVE TO ADMIT THERE IS SOME REAL PROBLEM THERE. >> WELL, WHAT I WOULD THINK WHAT WOULD HAPPEN IN THAT SITUATION IS THAT UNDER THE GUIDANCE, I THINK THAT THE INSTITUTION -- THE IRB IN A LIMITED REVIEW WOULD LOOK AT THE CONTEXT IN WHICH THE BROAD CONSENT WAS GAINED, AND WOULD TRY TO UNDERSTAND WHETHER THE FUTURE USE THAT WAS BEING ANTICIPATED UNDER OUR GUIDANCE WAS SOMEHOW SHOCKING TO OR WOULD BE SHOCKING TO THE INDIVIDUAL WHO HAD ORIGINALLY CONSENTED, GIVEN THE BROAD CONSENT IN THE CONTEXT OF A PARTICULAR CANCER STUDY. SO THAT DOESN'T ANSWER YOUR QUESTION ENTIRELY BUT IT DOES SAY THAT THINGS THAT WOULD BE GENERALLY BIOMEDICAL, ASSUMING THE BROAD CONSENT HAD A BROAD PURPOSE EXPRESSED, THAT WOULD BE -- THAT COULD THEN -- A RESEARCHER USING THAT COULD TAKE ADVANTAGE OF EXEMPTION, I GUESS IT WOULD BE UP TO THE INVESTIGATOR, YOU KNOW, AND THE INSTITUTION THAT'S AUTHORIZING THE ISSUANCE OF THE BROAD CONSENT TO REFINE THE EXTENT APPROPRIATE -- THE TOPICS SO FUTURE CATEGORIES OF USE APPROPRIATELY. >> I THINK WE SHOULD PROBABLY NOT GO -- SO IT STRIKES ME THAT CAR T JUST FROM THE SCIENCE, IT'S INDIVIDUAL TO THE -- TOTALLY INDIVIDUALIZED. I'M NOT SURE THAT THERE IS UTILITY IN THE FUTURE IN COMBINING ONE INSTITUTION TO ANOTHER. YOU DON'T HAVE -- IT ALL HAS TO BE THAT PATIENT. SO I DON'T WANT TO GET CAUGHT UP. I THINK THERE ARE IRB KIND OF ISSUES, IF YOU LINK THESE TO A TRIAL THAT HAS POTENTIAL FOR THERAPEUTIC BENEFIT, AND I THINK WE HAVE TO PROBABLY JUST TRUST THE IRB WILL ENTERTAIN THOSE AT THE TIME IT DOES ITS REVIEW, IF THE INVESTIGATORS TRY TO COMBINE IT. I AGREE THAT IN THOSE CIRCUMSTANCES WHERE YOU WOULD OTHERWISE WITHHOLD SOMETHING THAT COULD BE LIFE SAVING THERE'S A PROBLEM. BUT I'M NOT SURE -- YOU KNOW, THE LANGUAGE ACTUALLY IN THE GUIDANCE DOESN'T ADDRESS THAT. IT SUGGESTS BIOREPOSITORIES AND SUCH. I THINK WHAT WE HAVE IN FRONT MUCH US IS CLEAN BUT WE HAVE A CONCERN, WE HAVE A MECHANISM TO CONTROL FOR IT. >> THE NEXT SECTION IS IN REGARD TO THE DECISION TO REVERSE THE -- THAT IS TO WITHDRAW THE BROAD CONSENT. THE COST IS NOTHING. YES, WE CAN. YEP. >> WE TALKED ABOUT THIS A LITTLE BIT OVER THE BREAK, AND WE THOUGHT IT MIGHT BE ABLE TO BE CLARIFIED A BIT. SO THE LINE THAT SAYS NO NEW RESEARCH USES OF YOUR IDENTIFIABLE INFORMATION OR IDENTIFIABLE SPECIMENS WILL BE STARTED I THINK IS CLEAR ENOUGH. IF YOU WANT TO WITHDRAW, THAT'S FINE. WE'RE NOT GOING TO DO ANYTHING NEW BUT WE'RE GOING TO KEEP DOING WHAT WE HAD BEEN DOING. THEN THOUGH THE NEXT SENTENCE TALKS ABOUT ANYTHING ALREADY IN USE MAY NOT BE ABLE TO BE DESTROYED OR RETURNED, WHICH SUGGESTS THAT MAYBE IT WOULD BE, AND IT MIGHT HAPPEN, BUT I DON'T THINK THAT'S WHAT WE'RE PROMISING. SO WE WERE THINKING WE PROBABLY WANT TO CHANGE THE "MAY" TO A "WILL," RIGHT? IF YOU WITHDRAW YOUR CONSENT, WE'RE NOT GOING TO DESTROY OR RETURN YOUR STUFF. >> WELL, THE REASON, I MEAN, I'M HAPPY TO CHANGE IT ANY WAY YOU WANT TO CHANGE IT. THE REASON THAT I PUT "MAY" IN HERE WAS BECAUSE IN SOME CIRCUMSTANCES YOU ACTUALLY MAY BE ABLE TO CONTROL IT. SO I DIDN'T WANT TO MAKE A PROMISE THAT IT DEFINITELY WILL NOT HAPPEN WHEN IT MIGHT. >> MAYBE WE SHOULD PUT THAT PART OF THIS IN BRACKETS BECAUSE IT IS REFLECTING A CHOICE. >> OKAY, OKAY. >> WITHIN THE -- >> WE CAN DO THAT. >> OTHERWISE IT SEEMS LIKE OVERPROMISE OR POSSIBILITY, WHERE IT MAY NOT ALWAYS BE A POSSIBILITY. >> OKAY. >> AND THEN WE HAD ALSO THOUGHT IT MIGHT BE HELPFUL TO USE SIMILAR LANGUAGE THAT WE HAVE IN THE SECTION, IF YOU SAY NO, THAT IDENTIFIERS MAY BE REMOVED SO THAT THE MATERIALS COULD BE USED FOR FUTURE RESEARCH. WHETHER WE ALSO WANT TO PLUG THAT IN HERE. >> THAT'S SAID THREE TIMES IN HERE, THAT'S WHY I THINK WE DECIDED AS A GROUP NOT TO PLUG IT IN. WE CAN CERTAINLY PUT IT IN. >> IT'S RELATED TO THE COMMENT I THINK LESLIE WAS BRINGING UP BEFORE. >> OKAY. >> CAN I ADD TO THAT A LITTLE BIT? BECAUSE IT SEEMED TO ME THE REASON FOR THINKING -- THE REASON FOR EVEN THINKING ABOUT CHANGING WHETHER IT'S WILL, MAY OR GIVEN A CHOICE, NOT BE ABLE TO BE DESTROYED OR RETURNED, WAS RELATED TO THIS ISSUE OF DATA INTEGRITY, RIGHT? SO THAT ONE COULD ADD THERE, WILL OR MAY NOT BE DESTROYED OR RETURNED, SO THAT RESEARCHERS CAN MAINTAIN ACCURATE STUDY RECORDS OR SOMETHING LIKE THAT. AND THEN THE REST OF THAT SENTENCE, AND MAY CONTINUE TO BE USED IN STUDIES THAT STARTED BEFORE YOU CHANGED YOUR MIND, SHOULD ACTUALLY BE COMBINED WITH THE SENTENCE, NO NEW RESEARCH USES OF YOUR IDENTIFIABLE INFORMATION OR IDENTIFIABLE BIOSPECIMENS WILL BE STARTED, BUT THEY MAY CONTINUE TO BE USED IN STUDIES THAT STARTED BEFORE YOU CHANGED YOUR MIND, AND THEN YOU END WITH WE MAY NOT BE ABLE TO DESTROY OR RETURN, AND THAT HAS NOTHING TO DO WITH DOING FUTURE RESEARCH BUT HAS TO DO WITH DATA INTEGRITY AND THEN ADD THE "BUT THEY COULD BE DE-IDENTIFIED IN USE." >> I'M COMPLETELY -- WILL YOU WRITE THAT DOWN, NANCY, IF YOU DON'T MIND? >> YEAH, I'LL GIVE YOU NOTES. >> THAT WOULD BE GREAT. >> DO WE WANT TO ADD DE-IDENTIFIED USED INTO THE TEMPLATE? I THOUGHT WE WANTED TO DISCOURAGE THAT. >> I THINK IF THEY ARE GOING TO DO IT, IT SHOULD BE IN THE CONSENT BUT I DON'T WANT IT IN THE TEMPLATE CONSENT WHICH IS AN INVITATION TO DO IT, AS FAR AS I'M CONCERNED. >> I CAN PUT IT IN BRACKETS. >> YEAH. >> WELL, BUT MY PROBLEM WAS THAT IF WE SAY WE'RE REALLY -- WE REALLY DISCOURAGE DEIDENTIFICATION AND FUTURE USE WHEN PEOPLE HAVE SAID YES BUT THEN CHANGED THEIR MINDS, WHY DON'T WE ALSO REALLY DISCOURAGE THAT WHEN PEOPLE SAY NO FROM THE OUTSET? I DON'T SEE MUCH REASON TO TREAT THEM DIFFERENTLY. >> NANCY, SAY THAT AGAIN, I'M SORRY. >> LESLIE'S ORIGINAL COMMENT, WELL, IT'S PROBLEMATIC AND DISRESPECTFUL TO PEOPLE WHO HAVE SAID YES BUT THEN COME BACK AND CHANGE THEIR MINDS TO JUST GO AHEAD AND DEIDENTIFY THEIR STUFF AND USE IT ANYWAY. >> YEP. >> AND BUT THINKING ABOUT IT, PEOPLE WHO SAY NO FROM THE OUTSET ARE KIND OF IN THE SAME POSITION AND IF WE'RE NOT WILLING TO SAY WE REALLY THINK THAT WE SHOULD -- THAT YOU SHOULDN'T JUST DE-IDENTIFY THE PEOPLE'S STUFF IN THEY HAVE SAID NO, THEN WE SHOULDN'T TREAT PEOPLE WHO HAVE SAID YES AND THEN CHANGED THEIR MINDS ANY DIFFERENTLY. TO IT BECOMES AN ISSUE OF MAKING CLEAR WHAT CAN BE DONE RATHER THAN TRYING TO DISCOURAGE PEOPLE FROM DOING WHAT THEY ARE ABLE TO DO UNDER THE REGULATIONS. >> BUT WHAT ABOUT LEAVING IT AS A CHOICE IN BOTH CASES? I MEAN, AGAIN IN THE GUIDANCE, YOU KNOW -- >> I DIDN'T THINK OF THAT BUT I CAN'T ARGUE WITH IT. >> SO MAYBE THAT'S ALSO SOMETHING WE SHOULD ADD TO THE GUIDANCE, IF YOU REALLY GET -- I WANT TO SAY AN AFFIRMATIVE NO, WHICH DOESN'T SEEM RIGHT. AN EXPLICIT REFUSAL THAT WE DON'T -- YOU KNOW, YES, THE REGULATIONS ALLOW YOU TO STRIP IDENTIFIERS AND USE IT ANYWAY, BUT WE DON'T FEEL THAT THAT'S RESPECTFUL. WE CAN'T STOP ANYONE FROM DOING IT BUT -- >> THAT WOULD BE GREAT. >> ISN'T THIS A CONSENT TO USE THEIR IDENTIFIABLE DATA, NOT JUST THEIR DATA, BUT THEIR IDENTIFIABLE -- IT'S NOT A CONSENT TO STUDY PARTICIPATION, IT'S A CONSENT TO USE IDENTIFIABLE DATA? SO IF THEY SAY NO THEY ARE SAYING NO TO USE OF IDENTIFIABLE DATA. THE REGULATION COVER THE USE OF DE-IDENTIFIED DATA. I MEAN, AS A THEORETICAL MATTER, I AGREE IF SOMEONE DOESN'T WANT TO BE PART OF RESEARCH THEY SHOULDN'T HAVE TO BE BUT THEY DON'T REALLY HAVE THAT RIGHT UNDER THE REGULATIONS. >> I DON'T THINK IT'S A THEORETICAL MATTER. THAT RAISES PERSONAL ISSUES AND POTENTIALLY ISSUES THAT MAY AFFECT LONG-TERM RESEARCH ENTERPRISE. I THINK WE HAVE TO BE CAREFUL ABOUT IT, YEAH. >> I'M GOING TO TRY TO, YOU KNOW, CHANGE AROUND SOME OF THAT LANGUAGE IN THE DRAFT AND I'LL BRING IT BACK TO YOU TOMORROW TO LOOK AT. >> ONE MORE POINT ON THIS WITHDRAWING FROM THE STUDY, THE MORE I HEAR ABOUT IT THE MORE I THINK YOU CAN EFFECTIVELY WITHDRAW FROM THE STUDY, BUT IF YOU HAVE -- IF YOUR DATA HAS ALREADY BEEN PROVIDED TO SOMEONE ELSE, SOME OTHER INSTITUTION OR COMMERCIAL ENTITY, HOW CAN THEY -- HOW CAN THE STUDY GUARANTEE THAT IT WON'T BE USED IN ANY NEW STUDY? IT'S NOT UNDER THEIR CONTROL ANYMORE. I MEAN, IT COULD BE GIVEN TO A COMMERCIAL ENTITY WHO COULD GIVE IT TO SOMEONE ELSE. THERE'S NOTHING THAT SAYS YOU CAN'T DO THAT. AND SO YOU HAVE EFFECTIVELY LOST CONTROL. IT'S NOT LIKE YOU OWN THESE DATA AND YOU'RE THE ONLY PEOPLE THAT HAVE THEM AND YOU CAN CONTROL WHETHER A NEW RESEARCH ENTERPRISE WILL BE STARTED. SO-- >> I HAVE A RELATED ISSUE, AND THAT COMES TO THE TOPIC THAT WE'VE GONE AROUND HERE, THE NOTICE OF SCIENTIFIC INTEGRITY. AND CERTAINLY IN THE CASE OF INSTITUTIONAL BIOBANKS, IT'S NOT THE BIOBANK THAT HAS RESPONSIBILITY FOR INTEGRITY. IT'S THE INVESTIGATOR. AND SO TO THAT POINT AS WELL I DON'T THINK THE CONSENT CAN NECESSARILY SUGGEST THAT WE'VE GOT TO MAINTAIN THESE SPECIMENS TO MAKE SURE THE RESEARCH WAS DONE PROPERLY. >> (INAUDIBLE). >> BECAUSE THE BIOBANK'S P.I. IS NOT DOING THE RESEARCH. >> (INAUDIBLE). >> IF SOMETHING HAPPENS WITHIN THE BIOBANK, THAT'S NOT PART OF THE RESEARCH. YOU'RE SAYING THE BIOBANK IS NOT RESPONSIBLE? >> (INAUDIBLE). >> WELL, YEAH. THERE'S A PROBLEM WITH TEMPERATURE, THERE'S A PHLEBOTOMIST TAKING BLOOD FROM HIMSELF RATHER THAN PATIENTS, AND IT'S TRACKED DOWN THROUGH DNA, I MEAN, YOU KNOW, WHAT HAPPENS WITH BIOBANKS? >> MAYBE A BIT MORE RELEVANT EXAMPLE MIGHT BE THAT THE BIOBANK -- THAT THE BIOBANK IS SHARING INFORMATION IN A WAY THAT DOES NOT FOLLOW THE PROCEDURES, APPROPRIATE PROCEDURES, THEY ARE ESSENTIALLY -- SOMEBODY'S GOT A POSTDOC WHO WANTS TO DO A STUDY AND WITHOUT FOLLOWING ANY PROCEDURES THEY JUST PROVIDE SOME SPECIMENS TO THE POSTDOC. >> I AGREE HOW THAT COULD HAPPEN BUT I'M NOT SURE SAVING SPECIMENS WOULD ADJUDICATE THAT. >> I THINK THE PRIMARY ISSUE THAT ARISES IS THAT PEOPLE ARE WORRIED ABOUT, IS RESEARCH INTEGRITY, THAT IS IF AN INDIVIDUAL RESEARCHER TAKES THE STUFF OUT, CHECKS THE STUFF OUT OF A BIOBANK, DOES A STUDY THAT WOULD BE AN IN VITRO STUDY AND THEN WOULD -- THERE'S A QUESTION THAT ARISES LATER ABOUT WHETHER THE DATA ARE ACCURATE OR EVEN WERE COMPLETELY FABRICATED, AND THEN THAT'S WHEN ONE WOULD NEED TO MAKE SURE -- TO ACTUALLY HAVE THE SPECIMENS RETAINED IN ORDER TO BE ABLE TO GO BACK AND CHECK. RIGHT? >> I DON'T THINK THAT'S RESPONSIBILITY OF THE BIOBANK. >> I'M NOT SAYING IT IS. >> OKAY. >> THAT WOULD ACTUALLY BE THE RESPONSIBILITY OF THE INVESTIGATOR WHO CHECKED THEM OUT TO MAINTAIN HIS OR HER RESEARCH RECORDS AND RESEARCH MATERIALS, RIGHT? >> CORRECT. >> AND IF THE STUFF WAS RETURNED TO THE BIOBANK THE ALIQUOT RETURNED, WHICH THE BIOBANK WOULD HAVE RESPONSIBILITY FOR THAT. DEPENDS WHAT THE INSTITUTION OR PROTOCOL IS, WHO IS RESPONSIBLE FOR RETAINING BIOMATERIALS, THE IDENTIFIED BIOMATERIALS, THE IDENTIFIED DATA IN THAT CASE WOULD ALMOST ALWAYS REMAIN WITH THE INVESTIGATOR THOUGH. IN MY EXPERIENCE. >> WE'RE DISCUSSING THIS AS PROVIDING RATIONALE FOR RETENTION OF SPECIMEN. LANGUAGE IN THE ORIGINAL DOESN'T HAVE THAT. DOESN'T REFERENCE SCIENTIFIC INTEGRITY. IT'S BROADER. >> IN THE GUIDANCE IT SAYS THAT BUT NOT IN THE TEMPLATE, RIGHT. >> SO MAYBE WE JUST LEAVE THAT SPECIFICITY OUT WHICH IS I THINK WHERE WE START. >> OKAY. OKAY. THEN TO KEEP GOING, IS THERE ANY PAYMENT OR COMPENSATION FOR SAYING YES, ON THE TOP OF PAGE 5. THE ANSWER HERE IS BASICALLY THERE ARE PLANS OR NO PLANS TO COMPENSATE THE PERSON, AND THERE'S A CHOICE AS TO ONE WANTS TO COMPENSATE OR NOT. MOST PLACES PRESUMABLY CHOOSE NOT TO COMPENSATE, IT COULD BE HARD TO UNDERSTAND THE AMOUNT OF COMPENSATION THAT WOULD BE AWARDED, BUT IT'S POSSIBLE. THEN THE SECTION, IF YOU SAY YES, WILL YOU LEARN MORE ABOUT YOUR HEALTH, AND THE FIRST PARAGRAPH SAYS THERE'S NO PLANS TO TELL YOU ABOUT ANY SPECIFIC RESEARCH STUDIES THAT MIGHT BE DONE. THEN THE SECOND PARAGRAPH, I'M LOOKING AT IN LIGHT OF THE STUFF THAT REED SAID. WHAT WE'RE TALKING ABOUT HERE IS WE'RE TRYING TO MENTION INCIDENTAL FINDINGS. AND WHAT WE SAY IS THAT THE MOST OF THE TESTS DONE ARE FOR RESEARCH, HAVE NO CLEAR MEANING, FUTURE RESEARCH WITH IDENTIFIABLE INFORMATION OR BIOSPECIMENS GIVE RESULTS THAT DO HAVE MEANING THE RESEARCHERS MAY BUT ARE NOT REQUIRED TO CONTACT YOU TO LET YOU NO HE WHAT THEY HAVE FOUND, THAT WAS TRYING TO PRESERVE ABILITY OF RESEARCHERS TO RETURN INCIDENTAL RESULTS BUT NOT REQUIRE THEM TO DO SO. THAT WAS THE PURPOSE OF THAT LANGUAGE. IF THEY DO RETURN GENETIC -- THE REASON FOR THIS GENETIC TEST RESULT LANGUAGE IS FRANKLY BECAUSE OF THE NEW YORK STATE GENETIC TESTING LAW WHICH SAYS IF YOU EVER RETURN GENETIC TEST RESULTS YOU MUST ALWAYS SAY TO PEOPLE THAT THEY MAY WANT TO GET -- TO TAKE ADVANTAGE OF GENETIC COUNSELING. AND THE REQUIREMENT, IT JUST SAYS THIS IN THIS LAW DRAFTED 30 YEARS AGO AND SO WE WERE TRYING TO -- GIVEN THE PREVALENCE OF STUDIES THAT ARE DONE EITHER IN NEW YORK OR ON PEOPLE WHO ARE RESIDENTS OF NEW YORK, THAT WAS THE PURPOSE THERE. AND THEN THERE'S THE CLIA ISSUE ABOUT THE CERTIFIED LABORATORY WHICH WE TALKED ABOUT IN GREAT DETAIL. >> I DON'T KNOW IF YOU DISCUSSED HAVING A SMALL PHRASE ATTACHED TO THAT THAT THE SUBJECTS WOULD BE RESPONSIBLE FOR BEARING THE COST OF ANY FOLLOW-UP TESTING OR GENETIC COUNSELING. >> YEAH. >> WHICH COULD BE QUITE SUBSTANTIAL. >> I CAN PUT A SENTENCE IN TO THAT EFFECT, IF YOU LIKE. >> YOU KNOW, THIS ONE, I'M NOT SURE, BUT WE MAY ALSO WANT TO MAKE A CHOICE BECAUSE WHAT I'VE HEARD IN OTHER FORUMS IS THAT ACTUALLY THERE ARE A LOT OF PEOPLE WHO DON'T WANT TO GET THIS INFORMATION BACK. >> RIGHT, RIGHT. >> WE WITH MEDICAL BACKGROUNDS THINK THIS IS INFORMATION THAT WOULD BE PRACTICAL AND USEFUL TO PEOPLE. BUT PEOPLE FEEL VERY STRONGLY IN GENERAL THAT THEY MAY WANT TO GIVE THEIR SPECIMENS -- THEY HAVE NO INTEREST OR PERHAPS ACTUALLY ACTIVELY DO NOT WANT TO RECEIVE THE GENETIC RESULTS, SO -- >> (INAUDIBLE). >> I'M NOT REPRESENTING IT AS THE MAJORITY OF PEOPLE BUT THIS BASICALLY PUTS IT ALL IN THE RESEARCHERS. THE RESEARCHER MAY OR MAY NOT HAVE PLANS TO DO THIS. IT DOESN'T GIVE THE PARTICIPANT ANY CHOICE. AND I'M JUST NOT QUITE SURE HOW TO DO -- >> LET ME SUGGEST THIS. ONE THING THAT WE MIGHT DO IS WE MIGHT PUT A CLOYS IN HERE FOR THE INSTITUTION TO MAKE, AND THAT WOULD BE EITHER THAT IS AUTHORIZING THE OFFERING OF THE BROAD CONSENT, RESEARCHERS WILL NOT, ONE POSSIBILITY, WILL NOT RETURN RESULTS. THE OTHER IS HAVE THEM SAY WHAT IS HERE MAY OR MAY NOT BUT AT THEIR CHOICE, AND THE THIRD POSSIBILITY WOULD BE TO GIVE THE RESEARCH SUBJECT THE OPTION. WE COULD PUT ALL THREE ALTERNATIVES IN HERE, THEY ARE ALL THREE ALTERNATIVES. >> IRBs BECOME VERY UNCOMFORTABLE CONDUCTING A PIECE OF RESEARCH THAT HAS POTENTIAL TO PROVIDE SOMEONE WITH VERY IMPORTANT INFORMATION ABOUT THEIR HEALTH AND SAY THEY ARE NOT GOING TO GIVE IT TO THEM BECAUSE THE PERSON DIDN'T WANT IT. I'VE SEEN THIS LAYOUT, AND IT'S NOT -- >> NO, I MEAN AS A PRACTICAL MATTER IF THERE WAS AN URGENT FINDING, INCIDENTAL FINDING GENETIC OR OTHERWISE, AS IN OTHER CIRCUMSTANCES, AND WE'VE TALKED ABOUT THIS A LOT UNDER RETURN OF RESEARCH RESULTS, THAT WOULD BE A CLINICAL DECISION THAT WE TALKED ABOUT LAST TIME OR GO BACK TO THE IRB OR SOMETHING LIKE THAT. IT WOULDN'T JUSTING JUST BE DONE. >> IT GIVES FLEXIBILITY TO INVESTIGATOR AND IRB. THERE'S NO PERFECT ITERATION OF THIS, YOU KNOW, YEAH. IF YOU LOOK AT THE OPTIONS FOR RESPONDING TO THIS REQUEST, THE FIRST PARAGRAPH MAKES IT CLEAR WE'RE ONLY TALKING ABOUT IDENTIFIABLE STUFF AND NOT DEIDENTIFY ABLE A.IABLE. WE TRY TO MAKE THIS POINT SO THERE'S NO MISCONCEPTION ABOUT THE STATUS OF THE USE OF DE-IDENTIFIED BIOSPECIMENS AND DE-IDENTIFIED DATA. AND THEN WE HAVE THE BULLET POINTS MEANT TO SAY CLEARLY THIS IS WHAT HAPPENS IF YOU SAY YES, THIS IS WHAT HAPPENS IF YOU SAY NO, AND THIS IS WHAT HAPPENS IF YOU DON'T SAY ANYTHING. >> SO YOU'RE GOING TO UPDATE THIS TO TAKE INTO ACCOUNT THE EFFECT OF A PRIOR NO ON A SUBSEQUENT REQUEST? >> I'M NOT GOING TO UPDATE THIS. I'M GOING TO UPDATE THE DRAFT GUIDANCE. THAT'S ALREADY ON MY LIST OF THINGS TO DO. WE TRY TO DESCRIBE IN HERE IN WHAT HAPPENS IF YOU DON'T SAY YES OR NO THE AVAILABILITY OF THE WAIVER BUT TO DO IT THE WAIVER OF CONSENT FOR USE OF IDENTIFIABLE BIOSPECIMENS AND IDENTIFIABLE DATA BUT DO IT IN A WAY THAT WOULD -- IS ACTUALLY UNDERSTANDABLE TO MOST PEOPLE. THAT'S THE TEMPLATE. >> THANK YOU, MARK. I HAVE TO SAY I THINK YOU DID A GREAT JOB ARTICULATING ALL THE PIECES TO THIS. I THINK, YOU KNOW, IT'S NOT ENTIRELY STRAIGHTFORWARD AND IT'S A COMPLICATED FORM, BUT THANK YOU. SO OTHER COMMENTS? DIANA? >> (INAUDIBLE). >> IT WASN'T JUST ME. THERE WAS A BUNCH OF PEOPLE, ESPECIALLY NANCY AND HOLLY. >> THE VERY LAST SENTENCE, I MAY WITHDRAW AT ANY TIME WITHOUT PENALTY OR LOSS OF BENEFITS TO WHICH I'M ENTITLED. DO WE NEED TO HAVE THAT PENALTY OR LOSS OF BENEFITS? WHAT'S THE PENALTY AND WHAT'S THE LOSS OF BENEFITS? >> WE COULD -- THAT ESSENTIALLY HAS ALREADY BEEN SAID EARLIER. WE COULD TAKE THAT OUT IF YOU THINK THAT WOULD BE BETTER. THIS IS TELLING THEM A FINAL STATEMENT THEY HAVE THE ABILITY ONCE THEY GIVE THE BROAD CONSENT TO TAKE IT BACK. READY, I HAVE A DIFFERENT COMMENT. >> OKAY. >> DIANA, THIS IS JUST LIKE THIS IS LANGUAGE THAT APPEARS IN EVERY CONSENT FORM. AND IT'S NEVER MORE SPECIFIED THAN THAT. IT'S JUST THE IDEA THAT IT'S OKAY TO SAY NO AND YOU'RE NOT GOING TO -- >> (INAUDIBLE) >> REALLY? >> (INAUDIBLE). >> IF YOU WANT TO CHANGE THAT LAST LINE, THAT'S FINE WITH ME, WHATEVER YOU WANT. >> I THINK THE PURPOSE OF HAVING IT HERE IS BASICALLY TO SAY THAT, YOU KNOW, IT'S NOT ANY WORSE TO WITHDRAW THAN IT IS TO SAY NO. BECAUSE IT'S VERY -- IT'S STANDARD LANGUAGE, YOU CAN SAY NO TO THIS WITHOUT LOSING ANYTHING. SO. >> MARK, DID YOU WANT ANY COMMENTS ON THE COVER PAGE OR ARE WE JUST GOING TO SKIP OVER THAT? I HAVE A BROAD -- NOT WORDSMITHING COMMENT. >> A BROAD COMMENT? >> A BROAD COMMENT. >> THIS IS THE ONE-PAGE DOCUMENT, OUTSIDE, YEAH. >> I DON'T THINK IT'S GOING TO BE HELPFUL TO HAVE THIS ONE-PAGER. I DON'T KNOW IF WE WANT TO HAVE A BROADER CONVERSATION ABOUT IT. WE HAD PLAYED WITH LOTS OF PREAMBLE LANGUAGE TO THE BROAD CONSENT TEMPLATE AND ENDED UP STREAMLINING AND DROPPING VARIOUS THINGS. I LOOKED AT THIS FOR THE FIRST TIME YESTERDAY AND IT WORRIES ME BECAUSE IT'S A CLIFF'S NOTES VERSION, AND WE'VE ALREADY TRIED TO MAKE THE BROAD CONSENT, YOU KNOW, WE TWEAKED THAT LANGUAGE SO MUCH I WORRY IF THE CLIFF NOTES VERSION IS THE ONLY THING PEOPLE FOCUS ON, THERE'S GOING TO BE SO MUCH THAT THEY MISS. SO I THINK IT'S DANGEROUS IN THAT REGARD. THERE ARE SOME PARAGRAPHS THAT WE MIGHT BE ABLE TO PLUG INTO THE VERY BEGINNING. THERE'S A NUMBERED PARAGRAPH ABOUT WHAT THIS CONSENT FORM DESCRIBES, KIND OF A LITTLE MINI TABLE OF CONTENTS THAT I THINK MIGHT BE HELPFUL BUT OTHERWISE THERE'S SOME INFORMATION IN HERE ABOUT LOSS OF PRIVACY, RESEARCH WILL NOT BENEFIT YOU DIRECTLY, THAT SEEMS ONE SIDED WITHOUT -- SO I STARTED TO WORDSMITH IT AND EVERYTHING I WAS GOING TO CHANGE IS ALREADY IN THE LONGER DOCUMENT AND SO I JUST -- I THINK IT WAS A WORTHY EXERCISE TO TRY BUT I DON'T THINK IT'S GOING TO BE A HELPFUL THING TO LAYER ON TOP. >> THAT'S WHY I ACTUALLY DIDN'T REALLY PRESENT IT BECAUSE I THINK WHAT THE SUBCOMMITTEE IS RECOMMENDING IS NOT THAT PARTICULAR ONE-PAGER. I TRANSMITTED IT BECAUSE IT WAS PREPARED, BUT ANYWAY. >> YEAH, OKAY. THE IDEA BEHIND DOING THE ONE-PAGER AS WE KIND OF DECIDED TO DO ON THE LAST SUBCOMMITTEE CALL WAS EVEN THOUGH THAT -- THE NEW CONSENT ELEMENT OF PUTTING THE SUMMARY OF KEY POINTS UP FRONT IS NOT REQUIRED FOR BROAD CONSENT, THIS WAS SORT OF -- LET'S TRY IT HERE BECAUSE THIS IS A LONG, COMPLICATED CONSENT FORM. I DID ONE VERSION, DAVID DID ANOTHER VERSION, THAT COMBINED SOME OF MY STUFF AND NOT ALL, AND THEN MARK DID A FURTHER ITERATION MOSTLY FROM DAVID'S VERSION. MY CONCERN WAS WHAT YOU WANT IN THAT SESSION IS THE TRAILER FOR THE MOVIE, NOT A GUIDE TO HOW TO WATCH THE MOVIE. AND A LOT OF DAVID'S -- AND THIS SORT OF COMBINES BOTH. SOME OF IT IS LIKE HERE'S SOME KEY POINTS YOU'RE GOING TO READ MORE ABOUT LATER, AND OTHERS ARE YOU'RE GOING TO READ ABOUT THIS IN THE CONSENT FORM AND PAY ATTENTION. BUT WHAT YOU'RE ARTICULATING IS THE CHALLENGE OF WHAT IS SUPPOSED TO BE IN THAT NEW ELEMENT OF CONSENT GENERALLY. AND SO, YOU KNOW, DOING IT I THINK IS A REALLY USEFUL EXERCISE TO SORT OF HIGHLIGHT SOME OF THE DIFFICULTIES OF WHAT THAT CONSENT ELEMENT IS SUPPOSED TO BE. SO MAYBE WE DON'T PUT IT IN THE TEMPLATE BUT WE CONTINUE TO WORK ON IT TO SEE IF WE CAN ACTUALLY GET TO SOMETHING THAT WE CAN, YOU KNOW, GIVE ADVICE ABOUT FOR REAL CONSENT FORMS. >> I THINK IT'S A GOOD IDEA. MY SUGGESTION IS THAT YOU REARRANGE THE BULLET POINTS AS THEY APPEAR IN THE ACTUAL CONSENT DOCUMENT SO RATHER THAN HAVING YOU MAY SAY NO AS THE SECOND BULLET POINT I'D SAY WHAT THE HECK ARE WE GOING TO DO ABOUT THIS INFORMATION? PUT HOW THEY MAY BE USED. AND PRIVATE INFORMATION, BIOSPECIMENS ARE IDENTIFIABLE, PUT THE GUTS OF IT UP FRONT AND THEN SAY WHETHER THEY CAN AGREE OR NOT AGREE OR BE WISHY-WASHY. >> REED, IT WAS LIKE THAT FOR ABOUT TEN VERSIONS, I PROMISE YOU. I MEAN, YOU KNOW, IT REALLY WAS. AT FIRST WE -- THAT'S WHAT WE DID ACTUALLY. YOU WILL REMEMBER, HOLLY AND NANCY AND OTHERS, WE HAD AT THE VERY BEGINNING THIS IS BROAD CONSENT, IF YOU SAY YES THIS HAPPENS, IF YOU SAY NO THIS HAPPENS, IF YOU SAY SOMETHING ELSE THIS HAPPENS, HERE IS THE INFORMATION. THERE WAS A DECISION MADE A MONTH AGO, A MONTH AND A HALF AGO THAT IT NEEDED TO BE THE BEGINNING NEEDED TO BE MORE BACKGROUND AND PEDAGOGICAL, SO ONE COULD DO IT EITHER WAY. >> MARK, I'LL OBSERVE THE CONSENT FORM IS 6 SUBSTANTIVE PAGES, 6 AND A LITTLE BIT, NOT LONG AS CONSENT FORMS GO. HOWEVER, I THINK IT'S COMPLICATED ENOUGH THAT, AGAIN, GOING BACK TO OUR DISCUSSION ON GUIDELINES OF USE OF BROAD CONSENT PROCESS IT'S HARD FOR ME TO SEE SOMEONE AT POINT OF CARE OR AT ENTRY INTO THE HOSPITAL BEING PRESENTED WITH THIS AND REALLY TAKING THE TIME TO READ IT, UNDERSTAND IT AND UNDERSTAND THE OPTIONS SO I THINK IT'S, AGAIN, -- AND I THINK YOU'VE DONE A WONDERFUL JOB. THIS IS A GREAT DOCUMENT. IT'S AS SHORT AS WE'RE EVER GOING TO GET IT. THAT BEING SAID, IT STILL HIGHLIGHTS COMPLEXITY OF THE DECISION AND I -- FOR ME FURTHER EMPHASIZES THIS IS NOT AN APPROPRIATE DECISION TO ASK PEOPLE IN THE SETTING OF CLINICAL CARE. >> YEAH, AT LEAST VERY BEGINNING OF CLINICAL CARE, YOU KNOW. >> ONE VERSION OF THIS, A DIFFERENT DOCUMENT THAT MIGHT BE HELPFUL BUT SORT OF COMES FROM LOOKING AT THIS IS SOMETHING THAT SAYS -- THAT COMES AT THE END OF THE THIS DOCUMENT THAT SAYS BEFORE YOU SIGN THIS, PLEASE BE SURE YOU UNDERSTAND, AND HAS SORT OF A CHECKLIST OF WHAT ARE THE KEY ELEMENTS OF SOMEONE, I WANT TO MAKE SURE THEY UNDERSTAND, LIKE WHAT ARE THE RISKS, WHAT ARE THE BENEFITS, HOW IS YOUR INFORMATION GOING TO BE USED, SO IT SORT OF KIND OF CLUES PEOPLE BUT I'M NOT EVEN SURE THAT'S NECESSARY. I THINK IT WOULD BE MORE USEFUL THAN THIS DOCUMENT, WHICH I THINK WILL JUST BE CONFUSING. >> I MEAN, THIS IS A SORT OF -- A FAIRLY MINOR POINT, BUT THIS IS A FASCINATING DOCUMENT, AND IT'S REALLY WELL WRITTEN. AND I JUST THINK ALSO THERE'S A LITTLE NARROW POINT THAT SORT OF GIVES AN EXAMPLE OF WHAT I THINK PEOPLE ARE TRYING TO GET AT IN TERMS OF SUMMARY DOCUMENT BECAUSE IF YOU LOOK IN PARTICULAR LIKE IF YOU DO NOT SAY YES OR NO PART OF IT, IT'S ACTUALLY A LITTLE HARD TO FIGURE OUT THE CONSEQUENCES OF NOT SAYING YES OR NO, HOW IS THAT DIFFERENT THAN SAYING YES OR SAYING NO BECAUSE IT SPELLS OUT VARIOUS BULLET POINTS, AND BECAUSE I WAS JUST LOOKING AND TRYING TO FIGURE OUT, ONE OF THE REASONS WE WRITE HOW TO SPELL OUT THESE THINGS BECAUSE THERE CONSEQUENCING TO FAILING TO SAY YES OR NO AND BY FAILING TO SAY YES OR NO YOU'RE ALLOWING MORE RESEARCH THAN IF YOU SAID KNOW BUT IT'S FAIRLY HARD FOR YOU TO FIGURE THAT OUT BECAUSE YOU SOMEHOW HAVE TO COMPARE THE FOUR BULLETS UNDER DO NOT SAY YES OR NO TO WHAT IS UNDER IF YOU SAY NO, I'M JUST TRYING TO USE THIS AS AN EXAMPLE BY HAVING A SUMMARY, THE SUMMARY COULD POINT OUT IF YOU DON'T SAY NO, OR IF YOU DON'T SAY YES OR NO, YOU ARE ACTUALLY ENABLING RESERVERS TO DO STUFF THAT OTHERWISE THEY WOULDN'T BE ABLE TO DO. IT TAKES QUITE A BIT OF THINKING TO FIGURE THAT OUT, YOU HAVE TO COMPARE IF YOU SAY NO, WHICH HAS DIFFERENT PUTS, THAN IF YOU DO NOT SAY YES OR NO. IT IS AN INTERESTING EXAMPLE OF SOMETIMES THE BENEFITS OF TRYING TO PUT EVERYTHING TOGETHER IN AND UNDERSTANDABLE DIGESTIBLE WAY FOR PEOPLE. AND THAT WAS ONE OF THE MAJOR THEMES OF WHY YOU WOULD HAVE THIS KIND OF SUMMARY, YOU KNOW, SHORT THING AT THE FRONT. >> I THINK THAT'S EXACTLY WHAT WE'RE TRYING TO DO THOUGH WHEN WE HAVE THE WHAT ARE WE ASKING YOU TO DO BULLET IS GIVE PEOPLE PRETTY EARLY IN THIS DOCUMENT THE IMPORTANCE OF RESPONDING, AND IMPLICATIONS OF YES OR NO, RIGHT? SO THE DOCUMENT I THINK IS PRETTY USER FRIENDLY AND IT'S REPETITIVE, NOT IN A POORLY REDUNDANT WAY BUT THE CONSEQUENCES OF THE DECISION EITHER WAY. SO AGAIN I AGREE THAT WE SHOULD HAVE DONE THIS AS AN EXERCISE. I WAS IN FAVOR OF DOING IT ORIGINALLY BUT SEEING IT, I HAVE SOME WORRIES ABOUT HOW IT ACTUALLY WILL BE USED AND UNDERSTOOD. >> YOU KNOW, I ALWAYS TELL -- I TELL ASSOCIATES, LAW ASSOCIATES IN A LAW FIRM, YOU CAN'T CARE MORE ABOUT A CASE THAN YOUR CLIENT DOES. BECAUSE IF YOU DO, THEN YOU'RE FUNDAMENTALLY IN DISCORD WITH WHAT YOU'RE BEING ASKED TO DO. HERE, WE CAN'T MAKE IT ANY SIMPLER THAN WHAT THE REGULATION SAYS. THE FACT IS THESE REGULATIONS ARE REALLY -- THESE ARE COMPLEX CONCEPTS. SO THAT'S THE -- ULTIMATELY THAT'S THE ISSUE. WE CAN MAKE IT AS SIMPLE AS WE CAN. WE SHOULD, BUT IT'S QUITE A COMPLEX SETS OF CONCEPTS FOR US TO GRASP, MUCH LESS THE AVERAGE PATIENT OR CLIENT. >> MAYBE WE SHOULD CONSIDER ADDING A TABLE, A SMALL TABLE THAT JUST HAS THE CONSEQUENCES SO YOU KNOW WHEN YOU COMPARE DIFFERENT VERSIONS OF SOFTWARE TO BUY, BASIC, PRO OR DIFFERENT VERSIONS, THE TABLE WITH DOTS. MAYBE THAT'S SOMETHING SO PEOPLE CAN GLANCE AND SEE WHAT IT IS THEY ARE -- AFTER IT'S EXPLAINED, I WOULDN'T REPLACE IT, SO PEOPLE AT A GLANCE CAN SEE WHAT THEY ARE AGREEING TO OR NOT, JUST A THOUGHT. >> IT'S IN THE GUIDANCE, YEAH. >> (INAUDIBLE). >> SO I WILL -- THERE ARE A FEW EDITS TO THIS CONSENT FORM WHICH I'LL IMPLEMENT AND TRACK CHANGES. THERE ARE NOR CHANGES TO THE DRAFT GUIDANCE, I WILL TAKE NOTES AND TRY TO COME BACK TOMORROW TO YOU GUYS. IT WOULD BE NICE, YOU DO WHAT YOU WANT, YOU'RE THE BOSSES ABOUT WHETHER YOU ADOPT OR NOT BUT IT WOULD BE NICE FOR THE SUBCOMMITTEE WHO WORKED SO HARD ON THIS IF YOU GUYS WERE ABLE TOMORROW TO APPROVE GUIDANCE AND TEMPLATE AS RECOMMENDATION, UNDER THE TEMPLATE IS ONLY ONE VERSION OF INFINITE NUMBER OF THINGS THAT MIGHT BE DONE. >> I THINK, YOU KNOW, MUCH AS WE STAND WITH THE EXEMPT -- THE EXPEDITED LIST I THINK THE CONVERSATIONS HERE ARE MUCH MORE CONSISTENT AND ON BOARD THAN THEY WERE LAST TIME SO I THINK WE'RE CLOSE. SO LET'S BRING IT BACK TOMORROW AND WE'LL SEE WHAT WE CAN DO. >> OKAY. GREAT. STEPHEN, REALLY, NANCY KING AND HOLLY AND THE MEMBERS OF THE TWO SUBCOMMITTEES DID INCREDIBLE -- I DID A LOT OF WORK OBVIOUSLY BUT THEY DID AN INCREDIBLE JOB THEMSELVES OF GOING BACK AND FORTH AND BACK AND FORTH WITH ALL SORTS OF VERSIONS AND I THINK THAT EVEN WHEN WE DISAGREED THE CONVERSATIONS WITH HELPFUL IN GETTING TO THIS CURRENT STATE OF THE DOCUMENT. SO I JUST WANT TO RECOGNIZE IT WAS A GROUP EFFORT. >> THANK YOU ALL. AND I THINK WE ALSO HAVE TO RECOGNIZE THAT THIS IS SOMETHING THAT WE HAVEN'T DONE A WHOLE LOT OF ON THIS COMMITTEE, WHEN I'VE BEEN PART OF IT, WHICH IS TAKE SOMETHING THAT'S ENTIRELY NEW AND DRAFT SOMETHING REALLY FROM SCRATCH, THE GUIDANCE WITH NO PRECEDENT FOR A NEW CONCEPT. SO I THINK THIS WAS A HUGE PIECE OF WORK, AND THANK YOU ALL. SO IF THERE ARE NO OTHER ISSUES, WE'RE OPEN FOR PUBLIC COMMENT, IF WE HAVE ANYONE. >> I DON'T THINK THAT WE DO HAVE ANYONE WHO WANTS TO DELIVER PUBLIC COMMENT BUT IF THERE IS ANYONE NOW IS THE TIME. OKAY. >> ALL RIGHT. THANK YOU. I THINK IT WAS A GOOD DAY. AND I LOOK FORWARD TO SEEING YOU ALL BRIGHT AND EARLY TOMORROW MORNING. THANK YOU ALL. WE ARE ADJOURNED.