>> I'M JEFF BOTKIN, AND WELCOME EVERYBODY TO THE SECOND DAY OF OUR SACHRP MEETING. GETTING LOTS OF E-MAIL TRAFFIC LAST NIGHT AND THIS MORNING, FOLKS WANTING TO CONGRATULATE MARK IN PARTICULAR AND THE SUBCOMMITTEE CO-CHAIRS AND SACHRP FOR A LONG AND PRODUCTIVE CONVERSATION YESTERDAY. I CERTAINLY WANT TO ADD MY THANKS FOR A PRODUCTIVE DAY YESTERDAY AND I TRUST TODAY WILL BE THE SAME. SO I WANT TO TURN IT OVER TO JERRY FOR HIS WELCOME AND THEN WHY DON'T WE GO AROUND THE TABLE AGAIN TODAY FOR INTRODUCTIONS AND WE CAN ALSO WELCOME OUR COLLEAGUE MARIE KERRY. >> I THANK EVERYONE FOR THE PRODUCTIVITY AND THANK EVERYONE FOR MORE PRODUCTIVITY TOGETHER. >> I'M JIM CSR JAMES ANDERSON FOR MERCK. >> I'M PILLAR FROM THE UNIVERSITY OF WISCONSIN AND THE MORGAN INSTITUTE OF RESEARCH. >> MORNING, REED HARRIS FROM THE SCHOOL OF MEDICINE AT THE UNIVERSITY OF PENNSYLVANIA. >> HI, VALERIE, DIRECTOR OF RESEARCH, CLINICAL RESEARCH FOR THE SCIENCE POLICY AT NIH. >> GOOD MORNING, I'M TOBY WITH THE EPA. >> I'M JOANNE, DIRECTOR OF THE OFFICE OF CENTERERAL PRACTICE AT FDA. >> ANN ANDREWS DEPARTMENT OF COMMERCE. >> STEVEN ROSEN FORM. >> TOM ICEN BERG FROM VIRGINIA COMMON WELT UNIVERSITY. >> HOLLY FERNANDEZ, HARVARD LAW SCHOOL. DID EMPLOY. >> JONATHAN GREEN, WASHINGTON UNIVERSITY IN ST.LOUIS. >> GOOD MORNING, OWEN GAR RICK WITH BRIDGE CLINICAL RESEARCH. >> DIANNA CHRKS ING ES, I DO ADVOCATE RESEARCH IN LOSANGELES ON PATIENT REPRESENTATIVE HERE AND A CANCER SURVIVOR. -- >> SUSIE. >> JULIA OHRP. >> JERRY. >> ALL RIGHT, SO A BIT OF OVERVIEW OF TODAY'S AGENDA. WE HAVE A NUMBER OF PEOPLING WHO ARE GOING TO BE LEAVING BY ABOUT THREE, 3:15 OR SO, IF AT ALL POSSIBLE WE WOULD LIKE TO SEE IF WE CAN WRAP UP THESE DISCUSSIONS BUT I BELIEVE WE STILL HAVE QUORUM AFTER THAT TIME SO I THINK WE WILL HAVE PRODUCTIVE WORK EVEN AS FOLKS TRICKLE OUT, BUT IMPORTANT TO GET THIS WORK DONE WITH AS MANY PEOPLE AS POSSIBLE WHO ARE SACHRP MEMBERS SO WE'RE GOING TO MAKE THAT EFFORT. WE ARE GOING TO GO AHEAD WITH TWO PUBLIC COMMENTS TODAY AND I WILL HAVE A PUBLIC COMMENT AT THE BEGINNING OF THE AFTERNOON SESSION, AT ABOUT 12:30 OR SO. AND THEN WE'LL HAVE A SECOND PANEL THAT COMES IN ABOUT FOUR OR CLOCK OR SO DEPENDING ON HOW THE TIME WORKS AND HOW WE GET THROUGH OUR AGENDA. SO WE HAVE AT THIS POINT COMPLETED THE BIOSPECIMENS STATEMENT. WE HAVE SUBSTANTIAL INPUT ON THE SINGLE IRB ISSUE AND WE ARE GOING TO GO BACK TO THAT FAIRLY EARLY THIS MORNING. ONE OF WAS THE INTRODUCTORY BACKGROUND MATERIAL, WE DECIDED TO DEFER THE SECOND DRAFT RECOMMENDATION ON THE--WHAT REWERE PROPOSING AT THE LACK OF DISDISTINCTION BETWEEN HOW BIOSPECIMENS AND HOW DATA OR INFORMATION ARE MANAGED WITHIN THE NPRM, WE HAVE DECIDED TO DEFER THAT PENDING OUR DISCUSSION ON SPECIMENS, AND WE WANT TO RETURN TO THAT FIRST THING AND THEN WE WILL RETURN TO THE SINGLE IRB ISSUE AND GET THROUGH THAT PROMPTLY WITH REVISIONS NAMICHELLE HAS MADE AND THEN WE WILL DIVE INTO THE FORMAL AGENDA AS YOU HAVE SEEN IT EXCLIEWTIONZINGS AND EXTENSIONS UNDER THE NFRM AND TYPAL SET OF ISSUES WE WILL DEAL WITH AND CONTINUE THE REVIEW. SO THAT'S THE OVERVIEW. ANY QUESTIONS OR COMMENTS BEFORE WE JUMP INTO TODAY'S ACTIVITIES. >> ALL RIGHT, HOPEFULLY REED WILL BET UP TO SPEED ON WHAT WE HAD TO SAY FAIRLY QUAKILY. SO LET'S TURN TO THE--YESTERDAY'S DOCUMENT AND SCROLL DOWN AND I BELIEVE WE GOT THROUGH THE FIRST SET OF RECOMMENDATIONS TO THE EFFECT OF THE SUBSTANTIAL COMPLEXITY OF THE NPRM AND SUGGESTIONS ABOUT REVISING THAT TO BE MORE FOCUSED ON KEY ISSUES FOR WHICH THERE'S A HIGH LEVEL OF SUPPORT AND SECONDARY, REVIEW THE NPRM BEFORE ANY RULES ARE ISSUED. SO THOSE ARE CHANGES WE MADE THERE IN BEING SPECIFIC STAKEHOLDERS AND I THINK THE ISSUE UNDER CONSIDERATION WAS THE NEXT BULLET. THE DRAFT SAYS SACHRP, RECOMMENDS THAT DISTINCTIONS IN THE PROPOSED REGULATIONS BETWEEN RESEARCH WITH SUBJECT INFORMATION AND RESEARCH WITH BIOSPECIMENS BE REDUCED OR ELIMINATED, THE VALUES OF TRANSPARENCY SECURITY, CHOICE AND BEN FIVE ENSEL CAN BE PROMOTED ON BOTH DOMAINS THROUGH THE SAME OR SIMILAR PROTECTIONS. WE WILL RETURN TO THIS ONCE WE ATTEMPT TO HEAR MORE THINS I WILL STOP THERE AND SEE WHAT THE SENSE IS HERE THIS MORNING. >> I'M WONDERING IF WE NEED IT AT ALL IN THIS DOCUMENT [INDISCERNIBLE] AND I THINK THIS IS A QUESTION AND I MEANT TO ADDRESS IT. >> I HAVE TO SAY I LIKE IT AND THE COMMENT OVER AGAIN IF THERE'S ONE THAT--I DON'T KNOW OF ANYTHING THAT RAISED MORE HIGHER OR CONDEMN NATION IN THE BIOETHICS COMMUNITY THAT THE DISTINCTIONS MADE BETWEEN BIOSPECIMENS AND DATA AND I IT'S WORTH US SAYING. AND NOT JUST IMPLYING IT. >> I AGREE IN CONCEPT BUT ON THE OTHER HAND, I DON'T THINK I WOULD WANT TO SEE THE DATA OBJECTIVES THE SAME THAT WE PUT FORTH IN THE BIOSPECIMEN. SO THE WHOLE THING WOULD WORK AND CONCEPTUALLY, I DON'T AGREE THERE'S A MEANINGFUL DIFFERENCE FOR THE BIOSPECIMEN DATA BUT WE SHOULD AT COME UP WITH THE BIOSPECIMENS AND LIVES WOULD BE A LOT MORE COMMON AND THE DATA TOO. >> THERE ARE THINGS BETTER THAT ARE RELEVANT DIFFERENCES BETWEEN THE DATA, THAT I WOULD BE HAPPY WITH THIS THE WORD FROM WHICH TO MOVE. THE BIOSPECIMEN STATEMENT DOES IN MANY CIRCUMSTANCES DID REFER TO BOTH, SO IT DOES REFER EQUIVALENTLY IN SOME OF THE RECOMMENDATIONS THEY HAD TO IDENTIFIABLE SPECIMEN OR MAKING RECOMMENDATIONS FOR THE MANAGEMENT AND THE SENSE THAT IDENTIFIABLE SO I ACTUALLY LIKE THIS IN CONCEPT, I AGREE WITH JIM THAT THEY'RE DIFFERENT-- >> I AGREE IN CONCEPT, BUT MY ONLY CONCERN THAT THERE'S A LOT THAT FLOWS OUT IN THE WHOLE REST OF THE DOCUMENT AND OUR RECOMMENDATION NATHAT ASSUMES THEY'RE DIFFERENT OR WILL BE TREATED DIFFERENTLY, WITH INSTRUCTIONS TODAY ABOUT HIPAA COVERAGE AND OTHER THINGS. I DON'T KNOW--I LIKE IT AS AN IDEA AND I THINK IT'S--IT CAPTURES WHAT WE WANT I'M JUST CONCERNED ABOUT HOW IT FLOWS OUT WITH ALL THE REST OF THE RECOMMENDATIONS. THE OTHER COMMENTS SO WE HAVE THE OPINION AND THE VALUE OF THIS GIVEN--IF THERE WASN'T AN ALTERNATIVE, I WOULD COMFORTABLE WITH DOING THE WHOLE SECTION WITH BASICALLY THE SAME 81 SEPTORSS OR SIMILAR CONCEPTS COMING THROUGH IN THE BIOSPECIMEN THAT MAYBE THIS DOESN'T HAVE TO BE ELEVATED TO THIS LEVEL, SECOND POSSIBILITY WOULD BE TO ELIMINATE THE--ELIMINATE AND JUST HIGHLIGHT THE FACT THAT WE THINK THAT ANY DISTINCTIONS SHOULD BE REDUCED AND THAT CONCEPTUALLY WE DON'T THINK THERE'S A SIGNIFICANT MAYBE THE RESOURCES THAT THE NPRM MIGHT SUGGEST AND THE THIRD POSSIBILITY WOULD BE TO LEAVE JUST THE BACKGROUND DISCUSSIONS HIGHLIGHTING THE ISSUE TO THIS LEVEL BUT NOT MAKING IT OR ELIMINATING THE RECOMMENDATION ITSELF ASK JUST HAVE SOME BACKGROUND DISCUSSION THAT SAYS WE JUST WANT TO HIGHLIGHT THE FACT THAT WE FAIL TO SEE THE DISTINCTION THAT THE NPRMMAKES. >> MAYBE WE COULD LEAVE IT IN IT THE EVENT THAT THERE'S AN OPPORTUNITY TO RETHINK THE STRUCTURE AND COMPLEXITY AND GID APSE AND DIRECTION TO GO, SO I THINK IN THERE SENSE IT'S USEFUL AS A RECOMMENDATION BUT PERHAPS WE COULD QUALIFY IT IN THE TEXT WITH THE ACKNOWLEDGMENT THAT OUR OTHER RECOMMENDATIONS ARE BASED ON THE FRAMEWORK PRESENTED AND IN THE END HERE OR SOMETHING LIKE THAT. >> ALL RIGHT, I WANT TO MOVE ON FROM THIS FAIRLY QUICKLY BUT ANY GENERAL COMMENTS GETTING AT THIS POINT? CLEAR GUIDANCE ABOUT WHAT TO DO WITH THIS, SO HOW ABOUT AT A MINIMUM WE ELIMINATE THE ELIMINATED TERM SO THE RECOMMENDATION ONE IS DISTINCTION BETWEEN RESEARCH OR SUBJECT INFORMATION OR BIOSPECIMENS BE REDUCED. THE VALUES OF TRANSPARENCY SECURITY, CHOICE AND BENEFICENCE CAN BE PROMOTED ON BOTH DOMAINS THROUGH SIMILAR PROTECTIONS. ANY OTHER DISCUSSION? WHY DON'T WE GO AHEAD AND VOTE ON IT AT THIS POINT. DO I HAVE A MOTION. >> SECOND. >> ALL IN FAVOR. >> OPPOSED? ABSTENTIONS? ALL RIGHT, THANKS EVERYBODY. WHY DON'T WE GO ON AND MOVE THEN TO SINGLE IRB. >> THE COMPLEXITY PIECE WAS NOT ACTUALLY REVISED, YOU HAVE THE NOTION AS YESTERDAY, I WAS SAYING THAT CORRECTLY, SO I DON'T KNOW. >> OH I'M SORRY, LET'S GO BACK TAKE A LOOK AT THAT, AND I THINK WE VOTED THROUGH ON THOSE, AFTER THOSE CHANGES. >> I AGREE. BUT I DON'T THINK THE TEXT WAS ACTUALLY-- >> LET'S TAKE A QUICK LOOK AT THAT DOCUMENT AGAIN. >> ALL RIGHT SO I THINK IN THE FIRST SECTION, THE FIRST SENTENCE WAS PROBABLY WHERE WE ENDED UP AND THIS DIDN'T GET ANY CLEANING UP AFTER THE SESSION YESTERDAY. >> YEAH, I THINK ALL YOU NEED TO DO IS TAKE OUT THE SLASH AND SAY ALL YOU NEED TO IT MAKE YEARS, DUE TO THE OVERLAPPING NATURE OF EXCLUSIONS AND EXEMPTIONS IT NEEDS FOR TOOLS TO GID IMPLEMENTATION, ET CETERA AND YOU CAN DELETE THE REST. >> GOOD, THANK YOU YOU'RE GREAT AT EDITING ON THE FLOOR. AND THE NEED FOR TOOLS TO GUIDE IMPLEMENTATION. >> --AND MAKE COMPLIANCE COME DUE TO OVER LAPPING LAPPING EXEMPTIONS AND RULES TO GID LIMATION AND LITTLE BIT OF AWKWARDNESS ABOUT ELIMINATING THIS FOR SEVERAL YEARS. WHAT'S THE SUGGESTION NOW? CONTINUING CHALLENGE THERE. LET OKAY, WE RECOGNIZE THAT ANY REG LAT OARY CHANGE WILL REQUIRE A LEARNING CURVE BUT THOSE CHANGES REP REISN'T A LEVEL OF COMPLEXITY THAT WILL PERSIST AND MAKE COMPLIANCE A CONTINUING CHALGERG FOR YEARS TO COME DUE TO THE OVERLAPPINGINATEDDURE OF EXEMPTIONS AND THE TOOLS TO GID IMPLEMENTATION. DECADES TO COME. OUR CHILDREN WILL STRUGGLE. >> OKAY, I THINK THAT'S LOOKING GOOD. ANY OTHER EDITS. >> THE PARENTHETICAL EXAMPLE RIGHT THERE, DO WE WANT THAT? DO WE WANT TO PUT AN E. G. OR SOMETHING? >> SUCH AS BIOSPECIMENS, FOR THE HIGHLIGHTED TEXT. >> RIGHT HERE, RIGHT? >> YES. >> OKAY. >> AND I THINK ALSO SECOND LINE EG BIOSPECIMENS UP THERE AS WELL. OKAY, WE GOOD? THANK YOU. EXCELLENT. >> OKAY, MICHELLE, I THINK YOU'RE UP. >> GOOD MORNING, EVERYBODY, WE'RE BACK TO SINGLE IRB, SO JUST A REMINDER, YESTERDAY, THE CONSENSUS WAS TO SOFTEN THE LINE THAT TALKED ABOUT MANDATORY SINGLE IRB REVIEW, AND TO REORGANIZATIONALINIZE THE RECOMMENDATIONS INTO A BETTER FORMAT AND MAKE THE TEXT MORE CONSISTENT BECAUSE OF THE VOTE THAT INDICATED THAT SACHRPWAS UNABLE UNABLE TO ARRIVE AT A CENSUS, THERE'S REAL FORMATTIC ISSUES IN THIS ONE SO DON'T GET CAT UP IN THOSE I'M NOT QUITE THAT GOOD. SO THIS IS A TRACK CHANGE VERSION, RECOGNIZES THAT MANY HAVE FAVORABLE EXPERIENCES BUT THEN WHILE THE USE OF IT MAY PROVE TO BE EFFECTIVE AND EFFICIENT, SACHRP IS UNABLE TO ARRIVE AT A CONSENSUS REGARDING THE APPROPRIATENESS OF MANDATED IRB REVIEW AND FEDERAL FUND THE MULTICENTER TRIALS PART OF THE COMMON RULE AT THIS TIME. IF YOU WILL BEAR WITH ME, LET ME RUN THROUGH THE-- >> MICHELLE THAT SHOULD BE SINGLE I RB REVIEW, I THINK. >> WHAT DID I SAY? >> OH. [LAUGHTER] >> OKAY, YOU CAN TELL WHERE MY HEAD WAS YESTERDAY WORKING ON THIS. FORGET THAT IRB REVIEW, THAT WILL FIX EVERYTHING. THANKS TO THE MULTISITE TRIAL AS WELL AS MULTISITE STUDIES IT WILL ATTEMPT TO BE CORRECTED AND I'LL DO ANOTHER RECHECK ON THAT. SO WE HAD A DISCUSSION ABOUT ENHANCING THE PARAGRAPHS THAT TALKED ABOUT INDEPENDENT INSTITUTIONAL REVIEW BOARDS, SO SOME OF THIS WAS FROM YESTERDAY AND SOME OF IT WAS ADDED INDEPENDENT REVIEW BOARDS WHOSE PURPOSE IS TO SERVE AS A SINGLE IRB HAS BEEN OPERATING FOR DECADES, THEY'VE BEEN SHOWN TO BE EFFICIENT AND EFFECTIVE FOR MULTISENSOR RESEARCH AND PHARMACEUTICAL RESEARCH AND BIOTECHS UTILIZE SERVICES FOR INDEPENDENT REVIEW BOARDS FOR SINGLE SITE STUDIES, AND DATA SHOULD BE ANNOTATED REGARDING THEIR EXPERIENCE AS THIS WILL BETTER INFORM THE CONSEQUENCES OF SUCH A MANDATE ON VARIOUS STAKE OLDERS. THIS WILL ALSO PROVIDE INFORMATION AS TO WHICH TYPES OF RESEARCH WOULD MOST BEN FRIT FROM A SINGLE REVIEW MODEL AND WHICH WOULD RESEARCH BE EXCLUDED FROM. HOLD COMMENTS PLEASE. THAT'S AN CHANGED PARAGRAPH. THEN WE GET DOWN TO THE FORMATTING DISASTER. SO ALL OF THIS WOULD REMAIN AS HAS BEEN BEFORE, TAKING OUT THE PARAGRAPH RIGHT HERE AND INDEPENDENT REVIEW BOARDS BECAUSE IT WAS MOVED UP. AND THEN HERE ARE THE CHANGES, SACHRP, STRONGLY SUPPORTS, SO THIS IS THE PARAGRAPH THAT HAD TO BE ONE OF THE PHOTOGRAPHS THAT HAD TO BE MADE MORE CONSISTENT. BEFORE IT SAID SACHRP MANDATES IF NOT NECESSARY REGULATORY REQUIREMENTS. SO HERE IS HOW THE REVISION GOES, SACHRP STRONGLY SUPPORTS A MEASURED AND CAREFUL PROCESS, FOR THAT PART WOULD BE DELETED AND WE ALL VALUE COMMENTS. >> SO ONE POTENTIAL EDIT ON LINE 144, WHAT WE DO END UP RECOMMENDING, IF A MANDATE GOES FORWARD, A MORE NARROWLY TARGETED SET OF MANDATES. SO I WONDER WHETHER THAT WORD MIGHT BE ENTERTAINED--BY SAYING WE'RE TARGETED AND PROCESS. >> OVER HERE A MORE MEASURED AND CAREFUL-- >> INSTEAD OF MEASURES AND TARGETED WOULD BE THE IDEA. >> OKAY. NARROW COMES UP DOWN THE ROAD. SO THIS WAS THE LAST PHOTOGRAPH, I DELETED AND THE CENSUS WERE USED AND CAN ENHANCE EFFICIENCY AND DELETED THE SENTENCE BUT YOU SHOULD NOT BE REGULATORY MANDATES. >> ONCE AGAIN, MAYBE MINOR CHANGE HERE TO THINK ABOUT ON LINE 6F COULD SAY WILL ENHANCE RATHER THAN CAN, JUST A BIT MORE POSITIVE TONE. >> ALSO THAT SENTENCE SAYS THERE ARE INSTANCES AND END IN MANY CIRCUMSTANCES, PROBABLY WANT TO THINK ONE OF THOSE OUT. F I'M SORRY THE CHANGE THERE WOULD BE WILL ENHANCE. WHAT WAS THAT? >> MICHELLE IS DOING IT. >> HERE WE HAVE THE FORMATTING DISASTER. SO THIS WOULD BE THE TOPIC SENTENCE, THE FOLLOWING ARE SACHRP'S DETERMINE NATIONS FOR MANDATING SINGLE IRB REVIEW FOR DOMESTIC MULTISITE STUDY. SO CAN YOU OBVIOUSLY CHANGE IT BUT I SAID DETERMINE NATIONS HERE BECAUSE THAT FIRST PARAGRAPH IS THE ONE THAT DISCUSSES SACHRP'S DIVISION ON WHETHER A MANDATE IS PART OF THE COMMON RULES APPROPRIATE AT THIS TIME BUT THEN SEPARATELY, THERE WERE RECOMMENDATIONS OR SPECIFIC RECOMMENDATIONS. SO THE FOLLOWING ARE SACHRP DETERMINE NATIONS AND IN IS WHAT WE PROVIDED, THIS IS WHAT WE DRAFTED YESTERDAY. >> WHY DON'T YOU READ THAT JUST SO EVERYBODY HAS THAT, OR I CAN DO SO WITH YOU. >> I'M DYING UP HERE. >> SO SACHRP WAS MANDATED FOR A SINGLE IRB AS PART OF THE COMMON RULE, IT'S APPROPRIATE AT THIS TIME, HOWEVER THERE IS CONSENSUS FOR THE SINGLE IRB MAY NOT BE APPROPRIATE FOR A SIGNIFICANT--FOR SIGNIFICANT DOMAINS OF HUMAN SUBJECTS RESEARCH. IF THE FINAL RULE INCLUDES A MANDATE FOR A SINGLE IRB REVIEW, SACHRP SUGGESTS A NARROWER MANDATE THAT ARTICULATED--THAN THAT ARTICULATED IN THE NPRM, HHS AND OTHER DEPARTMENTS AND AGENCIES THAT FOLLOW THE COMMON RULE-- >> ALL RIGHT, ALL RIGHT. I WAS TRYING TO MAKE IT BIGGER. >> GOT DIZZY. >> ALL RIGHT. DAVID? >> WOULD CONTINUE TO HAVE THE OPTION OF ENCOURAGING US--HOLD ON. >> SO MICHELLE, THE TEXT UP THERE DOESN'T MATCH THE CLEAN COPY YOU SENT AROUND. >> --BY MAKING USE OF CRITERION AS DEEMED APPROPRIATE. >> YES, IN LINE 23, I ALWAYS GET HEART BURN WHEN THE WORD SIGNIFICANT IS USED IN THE ABSENCE OF THE STATISTICAL MEANING. AND SO I DON'T KNOW WHAT SIGNIFICANT MEANS IN THIS CONTEXT. >> COULD YOU CHANGE IT. >> SOME, MANY,. >> MANY OR. >> YEAH, MANY MIGHT BE GOOD. >> SO I'M A LITTLE CONFUSED BY THE LANGUAGE HERE, IF THRESHOLD'S A CENSUS THAT MANY SHOULD BE MANDATED FOR RESEARCH BUT IT'S UNCLEAR TO ME WHY WE'RE WATERING DOWN THE CONCLUSION THAT IT'S ADDRESSES THE SUGGESTION THAT THERE SHOULD BE A SINGLE IRB MANDATED FOR ALL AREAS OF RESEARCH, I THINK WE SHOULD BE VERY CLEAR THAT OUR RECOMMENDATION--THERE SHOULD NOT BE A SINGLE IRB MANDATED FOR ALL AREAS OF RESEARCH. IN MULTISITE STUDIES OF ANY TYPE. >> SO THE LANGUAGE STARTING ON ROW 23, IF IT FORCING A SINGLE IRB REVIEW, SACHRP'S SUGGESTS A MARROWER MANDATE. >> YEAH, IT SEEMS WISHY WASHY TO ME. >> WE HAD A SPLIT VOTE YESTERDAY SO-- >> BUT WE DIDN'T HAVE A SPLIT VOTE SPORTSMANSHIP THAT THERE WAS A CLEAR MESSAGE THAT THE SINGLE IRB SHOULD NOT BE MANDATED ACROSS THE ENTIRE DOMAIN OF MULTISITE STUDIES AND I FEEL LIKE WE SHOULD MAKE THAT POINT CLEARER. >> WHAT WE'RE SAYING IS-- >> THE FIRST SENTENCE TALKS ABOUT THE LOCATION OF WHERE THE MANDATE WOULD LIVE AND--SO POINT BEING, I THINK THE FIRST SENTENCE IS FINE IS NOT INCONSISTENT WITH WHAT FOLLOWS. >> I GUESS I WOULD BE HAPPIER WITH--IN THE SECOND SENTENCE, HOWEVER THERE IS CONSENSUS THAT A SINGLE IRB IS NOT APPROPRIATE FOR MANY DOMAINS OF HUMAN SUBJECTS RESEARCH, NOT MAY NOT. >> OKAY, GOOD. >> ELIMINATE THE BE THERE. >> SO CAN I ASK A QUESTION OF CLARIFICATION, SO THAT RECOMMENDATION, OUR RECOMMENDATION IS A MANDATE IN CERTAIN AREAS BUT NOT OTHERS, BUT ONLY IF THE FINAL RULE CONTINUES TO CONTAIN THE ACROSS THE BOARD MANDATE. LET THAT IS WE WOULDN'T RECOMMEND IF OHRP TALKED ABOUT MANDATING AT ALL THAT WE THINK IT SHOULD BE MONITORIDATED IN SOME DOMAIN. THAT'S SORT OF THE TRICKY ISSUE, IT WOULD BE IF HERE. >> I THINK IT WAS THAT SOME SENSE OF THE COMMITTEE DID MANDATE AN IDEA FOR SIGNIFICANT SEGMENTS SAY FDA REGULATED MULTICENTER TRIALS, BUT DID NOT FEEL TAP IT WAS APPROPRIATE TO MANDATE FOR OTHER TYPES OF MULTICENTER STUDIES, OTHERS FELT MORE COMFORTABLE SAYING IT SHOULDN'T BE MANDATED AT ALL, BUT IT SHOULD BE FOSTERED THROUGH OTHER MECHANISMS SO I THINK WE WANT TO CAPTURE THAT DISCREPANCY. >> I THINK THE IF CAPTURES IT, I JUST WANTED TO MAKE SURE THAT WE WERE SAYING. THAT OUR LIMITED MANDATE RECOMMENDATIONS ONLY MATTERS IF THERE'S AN ACROSS THE BOARD MANDATE IN THE FINAL RULE BECAUSE WE WOULD BE DIVIDED ABOUT WHETHER WE SHOULD RECOMMEND A LIMITED MANDATE WITHOUT THAT CONTEXT. >> OKAY, SO WHAT ARE THE IMPLICATIONS SO THE LANGUAGE IN THERE THAT ETHICALLY CAPTURES, YOU'RE SAYING, IS THAT THE SENSE AROUND THE TABLE? OKAY. OTHER CONSIDERATIONS? >> OKAY, SO THE RECOMMENDATIONS, SO THAT'S A STATEMENT, THE RECOMMENDATIONS WOULD BE A AND WE'LL GO THROUGH THOSE, A, B-WITH TWO BULLETS HERE, B, D, AND E. AND THE EFFORT WAS TO TRY TO CONSOLIDATE THESE A LITTLE BIT. SO, A IN THE EVENTED THAT SOME AMOUNT OF SINGLE IRB REVIEW IS MANDATED, CONSIDERATION SHOULD BE GIVEN TO THE FOLLOWING EXCEPTIONS TO SINGLE IRB REVIEW MANDATE, ONE THAT DESIGNATED SINGLE IRBs TO MEET THE NEEDS TO THE LOCAL IRB REVIEW REQUIRED, DOES NOT MEET THE DEFINITION OF CLINICAL TRIAL, OR RESEARCH THAT IS NOT FEDERALLY FUNDED, FIVE WAS FEWER THAN FIVE SITES AND SIX WERE THE FUNDING AGENCY DETERMINES THE SINGLE IRB REVIEW IS NOT APPROPRIATE. OKAY, I GUESS I WANT TO GO BACK TO NUMBER ONE IN THAT PARAGRAPH, AND THAT'S AS YOU SAID COMES OUT OF THE LANGUAGE FOR THE NIH BUT IT STILL SEEMS TO ME TO HIT THE WRONG NOTE IN THAT IT'S--IT SEEMS TO BE DESIGNATING FACT THAT ONE IRB CAN'T DO THE JOB, IT'S NOT CLEAR WHY ANOTHER ONE. ANOTHER SINGLE IRB MIGHT BE DESIGNATED TO TWO JOBS SO MIGHT WE CHANGE THAT TO SAY A SINGLE IRB IS UNABLE TO MEET THE NEEDS OF THE SPECIFIC POPULATION. >> YEAH, NO, I SEE WHAT YOU'RE SAYING AND MAYBE IT'S WHEN SINGLE IRB REVIEW IS UNABLE TO MEET THOSE NEEDS OR SOMETHING LIKE THAT BECAUSE THAT'S REALLY A CONCERN, NOT THAT WHATEVER A PARTICULAR DESIGNATED SINGLE IRB IS,. >> WHY NOT JUST REVIEW. >> BUT THAT ANY SINGLE IRB. >> BUT A REVIEW BY A SINGLE IRB. >> YES, YES, YES, YES. >> YEAH, I LIKE THAT. >> OKAY. >> ALL RIGHT. >> THIS IS MINOR BUT IT SEEMS KIND OF CHANGE, SOME AMOUNT OF SINGLE IRB REVIEW SO WE SHOULD SAY IN THE EVENT THAT A SINGLE IRB REVIEW IS MANDATED IN THIS CONTEXT OR CIRCUMSTANCES. >> I JUST WANT TO SAY SOMETHING ABOUT PERHAPS THIS RULE WOULD COVER FDA REGULATED RESEARCH SO PART OF THE DISCUSSION YESTERDAY WAS SAYING THAT IF THE MANDATE WAS GOING TO COVER FDA, PEOPLE WERE OKAY WITH THAT, THIS RULE DOESN'T COVER REGULATED RESEARCH, BY FDA, SOME PEOPLE THINK THAT IF IT'S MANDATED IT'S OKAY BECAUSE IT'S FDA, WE HAVE TO DO SEPARATE RULE MAKING, I WANT TO MAKE SURE YOU BED THAT. THIS RULE IS HARMONIZED BUT IT WILL NOT COVER FDA. I WANT TO MAKE THAT POINT. >> THAT WAS MY--MY COMMENT WAS TRYING TO PICK UP ON WHAT FOLKS WERE SAYING YESTERDAY, WHICH IS THE TYPES OF RESEARCH THAT ARE GENERALLY REGULATED BY FDA THAT ARE MULTICENTER TRIALS ARE THE TYPES OF ONES WHICH IT PROBABLY MAKES THE MOST SENSE TO HAVE A SINGLE IRB REVIEW. SO IT WAS MORE OF AN EXAMPLERATHER THAN--NOT INTENDING TO CONFUSE THE COPE OF THE REGULATION. >> YEAH, MAKE SURE THAT SOME AMOUNT WASN'T SUPPOSED TO BE FDA BECAUSE AS YOU SAID IT WAS A LARGER DRUG TRIAL AND DEVISE AND BIOLOGIC TRIALS DO NOT OFTEN USE SINGLE IRB REVIEW. >> OKAY, THANK YOU. >> I ALMOST HESITATE TO ASK THIS BUT I'M NOT SURE WHY WE HAVE AN EXCLUSION BASED UPON FUNDING. >> OKAY WHERE ARE WE TALKING. >> EXEMPTION FOUR RESEARCH THAT IS NOT FEDERALLY FUNDED. >> SO I THINK THAT GETS AT THE FOUNDATIONS THAT LIKE DANA-FARBER GETS FUNDS FROM THE SUSAN G. KOMEN FOUNDATION FOR DIFFERENT STUDIES, SOME CAN BE CLINICAL, SOME ARE NOT CLINICAL. I MEAN IF THEY'RE NOT CLINICAL, THERE'S LIMITING FACTOR OF TRIALS THEY WILL BE ELIMINATED, SOME MIGHT FALL UNDER CLINICAL TRIALS, AND I THINK THE IDEA WAS THAT THOSE THAT ARE NOT FEDERALLY FUNDED SHOULD NOT HAVE TO BE SUBJECT TO A REQUIREMENT FOR MULTISITE REVIEW BUT THIS IS OPEN FOR YOUR DISCUSSION. >> MY SPOINT FROM AN EARLY SUBJECT PROTECTION STANDPOINT, I DON'T SEE THAT THERE'S A DIFFERENCE. I GUESS, I WILL UNCHECK THE BOX, IT WOULD NOT APPLY ANYWAY, BUT MUCH FDA REGULATED RESEARCH IS NOT FEDERALLY FUNDED, I'M JUST NOT SURE WHAT WE'RE ACCOMPLISHING. >> THERE WOULD STILL BE IRB REVIEW FOR THOSE STUDIES, THE EXCEPTION WOULD BASICALLY SAY IT WOULDN'T BE SUBJECT TO A REQUIREMENT OR A SINGLE ILB. >> I UNDERSTAND THAT BUT WHAT IS THE SOURCE DETERMINE THAT, YOU KNOW WE THINK THIS IS ABOUT DOING GOOD RESEARCH AND GOOD SUBJECT PROTECTIONS, HOW DOES THAT ENFORCE THAT? >> I MEAN I WOULD ENTERPRETINAL LOCATION THAT AS AN EASY WAY TO LIMIT THE SCOPE OF ANY MANDATE, THAT'S ALL. >> I THINK I WOULD AGREE WITH THAT, I THINK MY SENSE IS HERE, WHAT WE'RE TRYING TO SAY IS, THE NPRM WOULD EXTEND THE COMMON RULE TO NONFEDERALLY FUNDED STUDIES IF THE INSTITUTION GETS FEDERAL FUNDING AND SO, I THINK THE EXAMPLE RAISED, FOUNDATION SUPPORTED MULTICENTER STUDY IS THERE A REASON WHY THE COMMON RULE SHOULD MANDATE SINGLE IRB ANDEE HAVE HESITATIONS AND IN THAT CONTEXT, WHY NOT LEAVE IT UP TO THE INVESTIGATORS AND THE FUNDER TO DECIDE WHAT SORT OF MODEL THEY--AND THE SENSE THAT THAT IS. >> DOES THAT SOUND RIGHT? >> YES. >> AS PART OF THE RECOMMENDATION, DO WE WANT TO JUST RECOMMEND THE EXCEPTION? >> IT WOULD MAKE THE LANGUAGE STRONGER, CERTAINLY. >> YOU COULD SAY IN THE EVENT OF SINGLE IRBREVIEWS, THE FOLLOWING EXCEPTION SHOULD BE INCLUDED. >> YEAH. >> DO WE WANT--DO WE WANT TO BE THAT FOURTH RIGHT ABOUT IT. >> WE ALREADY SAID SACHRP RECOMMENDS AT THE TOP. SO SACHRP RECOMMENDS THAT IT'S MANDATED FOR SOME RESEARCH, THE FOLLOWING EXCEPTIONS... SHOULD APPLY. >> SHOULD APPLY, MAYBE. >> LET'S TRY IT. >> I DON'T KNOW JONATHAN HAVE WE COVERED--ARE YOU OKAY WITH THE FUNDING THING. >> I AM, FROM A PRACTICAL STANDPOINT I LIKE IT BECAUSE IT GIVES IT THAT ABILITY TO [INDISCERNIBLE] LOGICAL PERSPECTIVE IN TERMS OF HUMAN SUBJECTS PROTECTIONS, THE FUNDING SOURCE SEEMS IRRELEVANT. >> YEAH, BUT ALTHOUGH THIS IS ALL TARGETED TOWARDS EFFICIENCY, SO I THINK IF IT'S NONFAIRLY FUNDED AND IT'S THE EFFICIENT WAY TO GO, THEY WILL USE THAT. IF THEY DON'T LIKE IT WHY SHOULD THEY BE FORCED TO DO IT FROM THE COMMON RULE WHEN THE FEDERAL GOVERNMENT IS FUNDING AND PROBABLY THE NOTION. >> OKAY HERE'S A, THE EXCEPTIONA PARAGRAPH B, IS THE DATA COLLECTION. SO HHS ENGAGE IN DATA COLLECTION REGARDING AND THE ADVANTAGES AND DISADVANTAGE OF USE AND DOMESTIC IRB MULTISITE RESEARCH, SO IT'S--DAY-TO-DAY COLLECTION REGARDING EXPERIENCES TO DATE WITH SINGLE IRB REVIEW, THIS COULD INCLUDE ONE IT'S OWN EXPERIENCE OF THE USE OF SINGLE IRBs FOR GRANTS THAT ARE MANDATED FOR A SINGLE IRB OR FOR THOSE GRANTS WHERE VOLUNTARILY UTILIZED--WE NEED TO GET RID OF COMMERCIAL, INDEPENDENT REVIEW BOARDS AND THREE EXPERIENCE EXPERIENCE--- >> SO AT THE RISK OF DIGGING A RABBIT HOLE LET ME ASK THIS QUESTION, IT SEEMS TO ME, THIS IS ANECDOTAL, I DON'T DO THIS RESEARCH, IT'S DIFFICULT TO GET IRBs TO OPEN UP ABOUT WHAT THEIR EXPERIENCE IS, THEY TEND TO BE FAIRLY CLOSED SHOPS, I THINK IRB DIRECTORS AND FOLKS GET SURVEYED ALL THE TIME BUT I THINK IRBs, MY IMPRESSION IS ARE PRETTY RELUCTANT TO SHARE MUCH IN THE WAY OF DAYA, DO PEOPLE THINK THAT'S A PROBLEM AND DO WE NEED IT ALL TO SAY, HERE'S A WAY OF SAYING SOMEBODY NEEDS TO DO RESEARCH ON THIS ISSUE BUT YET IRBs ARE RELUCTANT TO SHARE THEIR EXPERIENCES. MENT DO WE NEED TO SPEAK AT ALL TO THE NEED TO TRY TO OPEN UP THAT BOX IN A WAY TO ENABLE BETTER DATA COLLECTION ACROSS INSTITUTIONS. >> I THINK IT WOULD BE GREAT. I DON'T KNOW IF IT WOULD REQUIRE MORE THOUGHT AND CRAFTING TO FIGURE OUT WHERE TO PUT THAT. I MEAN I THINK THAT IS A LIMITATION. AND IT'S GOING TO MAKE IT HARD TO GET DATA THAT INTERPRETABLE BUT I DON'T KNOW HOW, WHETHER IT BELONGS HERE. >> ONE OTHER COMMENT BEFORE THE FIRST BULLET, WHAT DO--DOMESTIC IRB MODEL RESEARCH. >> SORRY. >> I DON'T THINK THAT GETTING DATA REVIEW BOARDS WOULD FALL IN THIS BULLET, THE ADVANTAGES AND DISADVANTAGES OF THE MULTISITE RESEARCH. BUT MAYBE YOUR QUESTION JEFF IS, DOES THERE NEED TO BE SOMETHING TO ENCOURAGE IRBs TO BE MORE OPEN ABOUT SHARING DATA ON THIS, IF SACHRP FEELS THIS IS AN IMPORTANT TOPIC. >> YEAH, THAT'S THE SENSE AND MAYBE IT DOESN'T BELONG AND FOLKS THINK IT'S AN ISSUE, THAT BELONGS TO SOME OTHER DISCUSSION BUT I DO THINK THAT MY IMPRESSION IS AT LEAST THAT WE MAY BE SETTING UP THE SYSTEM FOR CHALLENGES IF WE SAY WE OUGHT TO HAVE MORE DATA COLLECTION, BUT YET THAT'S VIRTUALLY IMPOSSIBLE TO DO BECAUSE IRBs AREN'T WILLING ON TO SHARE THEIR DATA. >> SO THAT COULD BE RELATED TO WHO'S DOING THE DATA COLLECTION SO WE SAY THAT HHS ENGAGE IN DATA COLLECTION WHICH SUGGESTS THAT IT WOULD BE AGENCIES MAKING REQUESTS OF THE REGULATED ENTITIES AS OPPOSE TO HHS FUNDING RESEARCHERS TO GATHER THAT DATA SO PRESUMABLY THE AGENCIES ARE MUCH MORE AUTHORITY, AND THAT'S WHAT WE INTEND AND THAT'S GREAT. I DON'T KNOW THAT WE WOULD ACTUALLY GET PICKED UP. >> THAT'S AN EXCELLENT POINT, WE SAY HHS SUPPORT DATA COLLECTION AND LEAVE IT UNSPECKIFIED WHETHER THEY DO IT OR IF THEY FIND SOMEBODY ELSE TO DO IT. >> OKAY AND MAYBE THAT'S SUFFICIENT AT THIS POINT TO ADDRESS THAT YOU KNOW WITH THE ISSUE RAISED. >> IT MIGHT BE WORTH IN THE FUTURE SACHRP SAYING SOMETHING MORE ABOUT DATA SHARING AND IRBs BECAUSE I KNOW A LOT OF INVESTIGATORS SAY TO ME, AND I MIGHT HAVE MENTIONED THIS IN PREVIOUS MEETINGS AND A LOT OF THEM SAY GOSH, WE'RE PUSHED TO SHARE DATA ALL THE TIME AND YET WE'RE NOT EVEN ALLOWED TO SEE OTHER PEOPLE'S CONSENT FORMS SOMETIMES WHICH WOULD BE SUPER HELPFUL TO US AND WE KNOW WE HAVE THAT DISCUSSION AND OTHER DOCUMENTS WITH THE CONSENT FORM BUT I KNOW IT FRUSTRATES INVESTIGATORS THAT THE IRB AND SO OPAQUE AND FRUSTRATES PEOPLE WHO WOULD LIKE TO STUDY AND UNDERSTAND MORE ABOUT IRBs. >> IT FRUSTRATES ABOUT IRBs WHEN WE GET A STUDY THAT WE KNOW HAS BEEN REVIEWED AND WE CAN'T FIND OUT WHAT THE DISCUSSION WAS, TREMENDOUSLY FRUSTRATING. >> OKAY, LET'S PUT MAYBE A PLACE ORDER FOR FUTURE DISCUSSION ABOUT THAT ISSUE. >> OKAY, SO MOVING PAST DATA COLLECTION ACTIVITIES, HHS SUPPORT MEETINGS WITH THE RESEARCH COMMUNITY WHERE ISSUES REGARDING THE USE OF A SINGLE IRB CAN BE DISCUSSED IN A PUBLIC FORUM. >> GOING ONCE? >> D-HHS FIND MECHANISMS TO ENCOURAGE INVESTIGATORS AND INSTITUTIONS TO VOLUNTEERS UNSUPPORTED TARLY UTILIZE SINGLE IRBs AS PART OF THEIR GRANT SUBMISSIONS RATHER THAN MANDATING REVIEW BY A SINGLE IRB. THIS COULD BE ACCOMPLISHED LIE PROVIDING INCENTIVES SUCH AS ADDITIONAL FUNDING TO THOSE GRANTS THAT AGREEN CELLS TO UTILIZE SINGLE IRB ARRANGEMENT? S, BASED UPON THE DATA ACQUIRED. >> WE'RE ON A ROLL. >> AND THAT WOULD BE THE CHANGES, THE LAST THING WAS NOT CHANGED AND IS SEPARATE AND INDEPENDENT AND HAS TO DO WITH THE TWO COMPLIANCE OVERSITE MECHANISMS THAT WERE IN THE NPRM. >> OKAY, THANK YOU. >> ALL RIGHT, SO FURTHER DISCUSSION. >> EVERYBODY OKAY WITH VOTING ON THESE AS A PACKAGE? VOTE OF APPROVAL. >> SECOND? >> SO THE NEXT STEP WILL JUST BE TO CLEAN IT UP. JUST THE FORMATTING AND ALL OF THAT. >> ALL IN FAVOR. >> OPPOSED, ABSTENTIONS? DO I SLEEP APNEA AND OBESITYY A HAND FOR APPROVAL? OKAY. MICHELLE THANKS. EXCELLENT WORK. >> [INDISCERNIBLE] >> JUST UNPLUG IT, YEAH. ALL RIGHT, THANKS AGAIN TO MICHELLE ON THE SUBCOMMITTEE FOR EXCELLENT WORK AND I THINK--AND SACHRP, I THINK WE'VE COME TO A NICE GROUND ON THIS SET OF RECOMMENDATIONS. ALL RIGHT NOW WE'RE GOING TO DIVE INTO EXCLUSIONS AND EXEMPTIONS. SO DAVID FORESTER. >> ALL RIGHT, GOOD MORNING. I THOUGHT I WOULD USE A QUICK SLIDE SET TO FRAME THIS ISSUE AGAIN, SINCE IT'S BEEN A WHILE THAT WE LOOKED AT AND THE RECOMMENDATION YOU HAVE IN FRONT OF YOU WAS ORGANIZED IT WAS DIFFERENT THAN IN THE ORIGINAL NPRM, AND I THOUGHT I WOULD GO BACK AND REFRAME IT FOR YOU AND MOVE BACK TO THE DISCUSSION OF THE INDIVIDUAL ITEMS. SO BASICALLY THIS IS ABOUT THE EXCLUSIONS AND EXEMPTIONS, RIGHT THAT ARE PROPOSED IN THE NPRM AND I'M GOING TO GO THROUGH THESE SLIDES VERY QUICKLY SO DON'T FEEL LIKE YOU NEED TO READ THIS AT ALL IN THE FRONT OF THE DOCUMENT SO GO THE NPRM WAS TO REDUCE MINIMAL RESEARCH, THAT WAS ONE OF THE CENTRAL GOALS, AND SO, A LOT OF THINGS THATTURENTLY REQUIRE IRB REVIEW, EXEMPTION, AND A LOT OF THINGS THAT WE'RE EXEMPTION WE'RE GOING TO MOVE TO EXCLUSIONS. >> SO THERE WAS THIS LESSENING OF ADMINISTRATIVE OVERSIGHT OF THESE LOWER TYPES OF RESEARCH AND CONSIDERED OF LOWER RISK. >> SO UNDER THE EXCLUSIONS THERE ARE 11 SPECIFIC TYPES OF ACTIVITIES DEEMED NOT TO BE RESEARCH AND WE'RE GOING TO LOOK AT EACH ONE OF THOSE SO NOT TO SPEND ANY TIME ON THEM HERE BUT YOU KNOW THAT THEY DON'T NEED DOCUMENTATION OF THE DECISION AND THERE'S NO RECORD ANYWHERE. >> THERE'S NO IRB REVIEW OR OTHER TYPE OF REVIEW FOR THE EXCLUSIONS. SO IN HAD THE FIRST CATEGORY THEY'RE NOT RESEARCH OR MIGHT BE RESEARCH BY INHERENTLY GOVERNMENT FUNCTIONS, THE SECOND CATEGORY WAS LOW RISK OR UNDER OTHER FEDERAL PRIVACY PROTECTIONS AND THE THIRD CATEGORY WHICH WE'RE NOT GOING TO ADDRESS INVOLVED BIOSPECIMENS AND THAT'S BEEN SUBSUMED UNDER THE BIOSPECIMENS. >> HERE ARE THE SIX--FIRST EXCLUSIONS, WE WILL TALK ABOUT EACH OF THESE, YOU KNOW WE'VE HAD DISCUSSIONS ABOUT THESE, I'M JUST GOING TO GET YOUR HEAD BACK INTO THE FRAMEWORK OF THE ORIGINAL ORGANIZATION. AND THEN THERE WERE THE FOUR EXCLUSIONS, AGAIN, THE SECOND CATEGORY OF THE LOW RISK ALREADY HAVING INDEPENDENT CONTROLS SO THE FIRST WAS THE EDUCATIONAL TEST PROPROCEDURES THAT WE'RE FAMILIAR WITH WITH THE CURRENT EXEMPTIONS AND THEN RESEARCH INVOLVING COLLECTION OF STUDY OR INFORMATION THAT WILL BE COLLECTED AND CURRENT BEFORE AND RESEARCH UNDER OTHER FEDERAL PRIVACY ACTS AND THEN FINALLY THE LAST FULL AFFAIR RESEARCH UNDER HIPAA. AND THEN THE THIRD CATEGORY AGAIN IS THE BIOSPECIMEN, SO THE GENERAL TAME FRAMEWORK FOR THESE EXCLUSIONS AS PROPOSED, AND THEN YOU MOVE TO EXEMPTIONS AND SO, UNDER THE CURRENT REGULATIONS THERE'S SIX EXEMPTIONS, SOME OF THOSE WERE MOVED TO EXCLUSIONS, SOME OF THEM WERE ALTERED, SO THEY ALL OF THE CURRENT EXEMPTIONS ARE THERE AS PART OF THE EXEMPTIONS OR EXCLUSIONS, SO NONE OF THEM DISAPPEARED SO THERE'S THREE CATEGORIES OF THE EXEMPTIONS SO 104 D ARE LOW RISK AND THEY DON'T REQUIRE THE APPLICATION FOR THE STANDARDS, STANDARDS OF INFORMATION FOR BIOSPECIMEN PROTECTION AND BONA FIDE PRIVACY, AND THERE'S 104 E WHERE THEY INVOLVE SINCATIVE INFORMATION AND THEY DO FALL UNDER THOSE--.105 INFORMATION SAFETY PROTECTIONS. TO REPLACE THE IRB REVIEW, EFFECTIVELY AND THE LAST ONE, 104, HAD TO DO WITH BIOSPECIMENS AND SO PURELY TO FRAME IT OUT. AND THERE'S ALSO THIS DECISION TOOL THAT WE NEED TO MAKE A RECOMMENDATION ON AND DO WE AGREE WITH THIS DECISION TO HAVE THIS OR NOT, THAT'S IN 104 C, SO WE CONSIDER THAT AN EXEMPTION DECISION, EXEMPTION RECOMMENDATION WE NEED TO DECIDE ON. OKAY, THESE FIRST CATEGORIES OF EXEMPTIONS ARE THE LOW RISK INTERVENTIONS MUST BE RECORDED BY AN APPROPRIATE INDIVIDUAL OR USING THAT TOOL, AND DO NOT REQUIRE THE PRIVACY PROTECTION STANDARDS, .105. SO THE FIRST WAS GOING TO BE BASICALLY THE EDUCATIONAL EXEMPTION WE CURRENTLY HAVE WITH ADDED LANGUAGE AT THE END. WE WILL TALK ABOUT THAT. NEXT ONE IS DEMONSTRATION PRONG ECTOMYOSINS BY GOVERNMENTS TO LOOK AT FEDERAL BENEFITS PROGRAMS, CURRENT B-FIVE, AND THEN A NEW ONE, RESEARCH WAS BENIGN INTERVENTIONS AND THAT ARE SOMEWHAT DESCRIPTIONED, SIMILAR TO THE CURRENT B-TWO, A BIT OF AN ADDITION, DENINE INTERVENTIONS AND THEN THERE'S INFORMATION ABOUT DECEIVING SUBJECTS AS PART OF IT. THE NEXT ONE IS THE CURRENT, THE TASTE AND FOOD QUALITY EVAL WRAWGZ AND CONSUMER ACCEPTANCE STUDIES AND NOW YOU GET THE COLLECTION OF SENSITIVE INFORMATION, NO BIOSPECIMENS, YOU HAVE TO USE THE TOOL AND NOW THE APPLICATION FOR THE DAT PRIVACY PROTECTION AT 105 PROTECTIONS APPLY AND AGAIN KIND OF THINK--THINK AGAIN THAT REPLACES THE EXPEDITED REVIEW OF WHAT HAPPENED. BECAUSE THE IDEA WAS THE MAIN RISK OF THESE WAS BREECH OF CONFIDENTIALITY. SO THEN YOU HAD RESEARCH NOT INCLUDING INTERVENTIONS THAT INVOLVES, INFORMATION THAT'S RECORDED IN A WAY THAT SUBJECTS ARE IDENTIFIED AND THE NEXT ONE IS SECONDARY RESEARCH USE OF PRIVATE INFORMATION, ACQUIRED FOR NONRESEARCH PURPOSES WHERE NOW YOU GET THIS PRIOR NOTICE, HAS BEEN COLLECTED, HAS BEEN GIVEN TO THE INDIVIDUALS WHO REALLY KNOW THE DESCRIPTION OF WHAT THAT PRIVATE NOTICE WILL LOOK LIKE, ONE THING WE MIGHT WANT TO DO IS REFER TO WHAT WE DID IN THE BIOSPECIMEN RECOMMEND ANTICIPATION AND ONLY IT FOR THE SPECIFIC PURPOSES FOR WHICH THE INVESTIGATOR RECIPIENTS AND THE REQUESTED ACCESS TO THE INFORMATION, SO THE INFORMATION WOULDN'T GET PASSED ALONG TO RESEARCH PROJECTS. SO THAT IS JUST A VERY--AND THE THIRD IS A BIOSPECIMEN. SO I WANT TO VERY QUICKLY REFRAME THAT. AND IF YOU WANT TO REFER BACK TO IT, YOU ALL RECEIVE THIS ACTUAL VERSION OF THE COMMON RULE AND THE EXTRAMURAL CLIEWGZS ARE ON PAGES TWO-FOUR AND THE EXEMPTIONS ARE PAGES EIGHT-11 SO GO LOOK AT IT WHILE WE'RE TALKING TO LOOK AT THAT FRAMEWORK IN MIND. THAT WILL BE FINE. SO LET ME SAY BY WAY OF GETTING UP THE NEXT DOCUMENT HERE, I THINK WHAT WE WANT TO TRY TO DO HERE IS NOT WORRY TOO MUCH ABOUT THE BIOSPECIMEN AND INFORMATION RECOMMEND ANTICIPATIONS THAT WE MADE YESTERDAY BECAUSE THERE WAS SOME REQUEST ABOUT WHETHER WE SHOULD TRY TO HARMONIZE RECOMMENDATIONS ON THE EXEMPTION AND EXCLUSIONS ON THE RECOMMENDATIONS ON BIOSPECIMENS AND I THINK IT BECAME CLEAR THAT THAT WOULD BE AN ENORMOUSLY COMPLICATED TASK BECAUSE SO MANY OF THESE THINGS ARE INTERWOVEN SO I THINK WE'RE GOING TO TRY TO DEAL WITH THESE MOSTLY ON THEIR OWN, ON THEIR OWN BASIS AND IF VARIOUS ASPECTS OF WHAT WE RECOMMEND ARE SUPPORTED IN A FINAL RULE OR ANOTHER NPRM AS THE CASE MAY BE, THEN OTHERS WILL HAVE TO SORT OF FIGURE OUT HOW TO WE'VE THOSE TOGETHER, SYNTHESIZE THEM IN A WAY THAT MAKES SENSE. THAT'S ACCEPTABLE TO FOLKS? >> YEAH. >> I DID SPEND ABOUT TWO HOURS OVER THE HOLIDAY WEEKEND TRYING TO CORRELATE THIS WITH THE BIOSPECIMEN RECOMMENDATION AS THEY STOOD AT THAT POINT. AND I JUST GAVE UP. I COULDN'T PUT IT ALTOGETHER FOR A MULTITUDE OF REASONS. SO WHAT WE DO SAYULARY IS EXACTLY WHAT JEFF JUST SAID. WE ARE LOOKING AT THESE AS THEY STAND. WE MADE THESE RECOMMEND ANTICIPATIONS, BUT YOU KNOW IF THE-HISTORY THE RECOMMENDATION REGARDING BIOSPECIMENS AND THE DATA ARE ADOPTED, THEN THESE RECOMMENDATIONS REGARDING EXCLUSIONS AND EXEMPTIONS SHOULD BE CONSIDERED TO BE SUBSERVIENT AND MODIFIED AS NECESSARY TO MEET THOSE RECOMMEND ANTICIPATIONS, SO THIS IS IN THE ALTERNATIVE, THIS THESE ARE STILL STANDING AT TED END OF CONSIDERATIONS BY THE AGENCIES, THEN WE HOPE THAT THEY WOULD LOOK ATEUR RECOMMENDATIONS. DOES THAT MAKE SENSE? OKAY. >> THEN THE WAY WE DECIDED TO ORGANIZE THIS, STARTING WITH EXCLUSIONS, THOSE THAT ARE ACCEPTABLE AS PROPOSED, NO CHANGES THEN SHOWS THAT NEED MINOR MODIFICATIONS AND THOSE THAT NEED TO BE REJECTED. >> SO WE'RE DEALING WITH THOSE 11 EXCLUSIONS. AND SO WHAT I DID IS I GROUPED THEM BY THOSE THREE CATEGORIES, SO FIRST WE HAVE THE ONES THAT THROUGH THE SAC HRP, AND THE SUBCOMMITTEE DISCUSSIONS, THE MAJORITY AS WE END UP THROUGH THE PROCESS BELIEVE THAT THESE COULD BE RECOMMENDED FOR APPROVAL AS DRAFTED. SO THE FIRST ONE IS THE 101, THREE, THIS IS COLLECTION CAN ANALYSIS OF DATA BIOSPECIMENS OR RECORDS BY OR FOR A CRIP NAME JUSTICE ASSOCIATE, WE'RE MOVING THIS WILL BE EASY. ALL RIGHT. [LAUGHTER] >> THIS IS 101 B-FIVE, THIS IS PUBLIC HEALTH SURVEILLANCE ACTIVITIES INCLUDING THE COLLECTION AND TESTING OF BIOSPECIMENS CONDUCTED, SUPPORTED, REQUESTED ORDERED REQUIRED, OR AUTHIZED BY A PUBLIC HEALTH AUTHORITY AND LIMITED TO THOSE NECESSARY TO ASHES LOW THE PUBLIC HEALTH AUTHORITY TO IDENTIFY, MONITOR ASSESS OR INVESTIGATORS POTENTIAL PUBLIC HEALTH SKIING SHALLS. --SO VERY PUBLIC ORIENTED SIMILAR TO CDC. OKAY, GREAT. THE NEXT ONE IS 101 B-1, SIX, THIS IS SURVEYS, INTERVIEWS,A ACTIVITIES, RELATED ANALYSIS OF USE OF BIOSPECIMENS CONDUCTED BY DEFENSE, NATIONAL SECURITY OR HOMELAND SECURITY AUTHORITY SOLELY FOR AUTHORIZED OR NATIONAL SECURITY. >> SO WE HAVE PUBLIC COMMENT NA'S BEEN FAIRLY EXTENSIVE ON THIS ONE. I DON'T CLAIM TO CLEARLY UNDERSTAND WHAT THE GOANCH OF SCOPE OF ACTIVITIES AND I DON'T THINK WE HAVE THE EXPERTISE TO HAVE TOO KNOWLEDGEABLE SET OF THOUGHTS OR COMMENTS ABOUT THIS PARTICULAR EXCLUSION, BUT I WANT TO BE SENSITIVE TO THE PUBLIC COMMENT THAT WE'VE HAD. SO I'M WONDERING WHETHER WE MIGHT INCLUDE HERE, NOT--INCLUDE HERE PERHAPS ENCOURAGEMENT FOR AGENCIES TO BE MORE TRANSPARENT ABOUT THE SCOPE AND NATURE OF THIS EXCLUSION FOR THE PUBLIC SO THAT THERE'S BETTER UNDERSTANDING OF WHAT--WHAT'S REALLY BEING AUTHORIZED IN THIS EXCLUSION. SO LET ME JUST THROW THAT OUT FOR OTHER PEOPLE'S THOUGHTS. >> WELL ONE THING I THOUGHT I SAW, SOMEWHERE IN THE NPRM AND I HAD DONE A LOT OF SEARCHES BUT UNFORTUNATELY DIDN'T SAY THE RESULT, WAS THAT THERE WAS SOMEWHERE ELSEWHERE THE WORD LAWFUL AS ISSUES OPPOSE TO THE WORLD AUTHORIZED IN CONJUNCTION WITH THE WORD AUTHORIZED AND IT IS TRUE THAT IN THE PAST, UNLAWFUL SURVEILLANCE HAS BEEN CONDUCTED. SO AT THE VERY LEAST, I WOULD SUSPECT WE WOULD BE TALKING ABOUT EXCLUSIONS FOR AUTHORIZED AND LAWFUL ACTIVITIES, NOT JUST AUTHORIZED. >> SO JUST TO BE CLEAR, UNLAWFUL ACTIVITIES WOULDN'T BE EXCLUDED. >> AND I THINK CONSISTENT WITH LANGUAGE BUT PERHAPS WORTH A COMMENT FROM US IS, I READ THIS TO MEAN NONINTERVENTIONAL ACTIVITIES. >> WELL, MY ASSUMPTION WAS THAT THIS WAS AN EXCLUSION BECAUSE IT WAS NOT DESCRIBING RESEARCH. SO I'M NOT--I'M WONDERING WHETHER ASIDE FROM A GENERAL COMMENT ALONG THE LINES OF JEFF THAT JEFF MADE WE SHOULD BE TINNINGERRING WITH ANY LANGUAGE HERE BECAUSE IT DOESN'T COME UNDER THE COMMON RULE IF IT'S NOT RESEARCH. SO MAYBE THE CLARIFICATION IS THAT THIS IS REFERRING TO ACTIVITIES THAT DON'T CONSITUTE HUMAN SUBJECTS RESEARCH: >> --SURVEY. >> --YEAH, SO SURVEYS INVOLVE IRPT ACTIONS WITH HUMAN SUBJECTS, INTERVIEWS INVOLVE INTERACTIONS WITH HUMAN SUBJECTS, SURVEILLANCE ACTIVITIES COULD POTENTIALLY INVOLVE ADJUSTING THE ENVIRONMENT SO, AT LEAST I CAN--I CAN SEE WAYS IN WHICH PARTS OF THE FIRST THREE WOULD BE HUMAN SUBJECTS RESEARCH UNDER THE PRESSENT COMMON RULE. >> ANYBODY WANT TO COMMENT ON THIS. >> I GUESS WE WANT TO KEEP IT IN THE ONES THAT WERE NOT--WE COULD BUMP IT INTO THE MINOR MODIFICATIONS ONE IF WE WANT TO INCLUDE THE LAWFUL INTELLIGENCE PHRASE. THE OTHER WAY TO DO THAT WOULD BE TO SAY THAT SACHRP MEANS AUTHORIZED MEANS LAWFUL, AND, WELL,-- >> BUT REALISTICALLY IF IT'S UNLAWFUL IT'S NOT GOING TO BE BROAD REVIEW-- >> NONTHIS OF THIS IS GOING TO BE BROUGHT FOR IRB REVIEW-- >> I UNDERSTAND. BUT IF YOU MAKE IT EXPLICIT, I UNDERSTAND THE INTENT BUT I'M NOT SURE IT ACTUALLY ADDING ANYTHING MEANINGFUL, THEY'RE AUTHORIZED ACTIVITIES: THEY SHOULD BE AUTHORIZED UNDERLAW. >> EACH UNAUTHORIZED ACTIVITIES, WOULD ALSO NOT BE BROUGHT FOR IRB REVIEW, RIGHT? SO IT'S-- >> I MEANT OVERSIGHT--OR, YEAH. >> OTHER THOUGHTS ABOUT THE LAWFUL ELEMENTS HERE? >> I AGREE WITH STEVEN. >> THAT WE SHOULD AGREE THAT AUTHORIZES ENCOMPASSES THE NOTION OF LEGAL. >> I'M UNDERSTANDING THE REASON WE'RE POTENTIALLY OKAY WITH THIS TYPE OF HUMAN RESEARCH SUBJECTS EXCLUDED IS PRESUMABLY EITHER THAT IT'S SOLO RISK THAT WE DON'T NEED TO WORRY ABOUT IT OR THAT THERE ARE SUCH SUBSTANTIAL NATIONAL SECURITY OR INTERESTS THAT AN IRB THAT THEY WOULDN'T WANT TO SHARE INFORMATION WITH AN IRB FOR OVERSIGHT PURPOSES. RIGHT? ARE THOSE THE TWO IDEAS? >> WELL I THINK I WILL DEFER TO FOLKS WHO MAY HAVE--MAY REMEMBER WHATEVER BACKGROUND INFORMATION THE NPRM HAS ON THIS AND PART OF WHY I'M STRUGGLING WITH IT IS THAT I DON'T ACTUALLY UNDERSTAND WHAT THE NATURE AND SCOPE OF THIS IS, AND SO, THAT'S WHY I WOULD BE RELUCTANT TO RAISE CRITICISM ABOUT IT AND SO, THE REASON I'M RAISING CONCERN IS BECAUSE OF THE LEVEL OF PUBLIC CONCERN ABOUT THIS ISSUE. >> I AGREE WITH THAT BUT ALSO THE FACT THAT WE DON'T UNDERSTAND IT MAKES ME NERVOUS ABOUT SAYING, YEAH, GO AHEAD WITH AN EXCLUSION. IF WE DON'T UNDERSTAND IT, IT COULD BE SOMETHING WE PULL OUT COMPLETELY AND SAY, WE'RE NOT--WE CAN'T MAKE RECOMMEND ANTICIPATIONS ABOUT THIS BECAUSE WE DON'T FULLY UNDERSTAND WHAT'S BEING PROPOSED AND WHY. >> YEAH, I MEAN THERE IS CLASSIFIED RESEARCH THAT GOES FORTH WITH IRB REVIEW, RIGHT? SO MY SUSPICION IS THAT THIS AT THIS TIME UNDERLYING IDEA HERE IS THAT CERTAIN THINGS MIGHT NEED TO BE DONE VERY QUICKLY AND THAT AS A MATTER OF NATIONAL SECURITY, THE PEOPLE WHO ARE ENGAGED IN THOSE ACTIVITIES MIGHT, YOU KNOW--MIGHT NOT FEEL THEY HAVE THE TIME OR THAT IT WOULD BE APPROPRIATE FOR AN IRB TO BE CALIFORNIAING THEM, WELL, YOU HAVE TO CHANGE THIS QUESTION THAT YOU ARE GOING TO ASK PEOPLE, RIGHT? SORE SOMETHING LIKE THAT. THE. >> THAT, YOU KNOW, SO MY UNDERSTANDING AND I HAVEN'T READ THE BACKGROUND ON THIS FOR A WHILE BUT MY UNDERSTANDING IS THAT THE NATIONAL SECURITY MANDATE OR THE IMPORTANCE OF THAT, AND THE EXPERTISE IN THAT RELATIVE TO AN IRB WOULD MEAN THAT THE PEOPLE JUST DIDN'T WANT IRBs INTERFERING IN THESE ACTIVITY WHEN IS THEY NEEDED TO GO FORWARD. >> SO I GUESS I HAVE TO SAY AND IT MAY END UP BEING NAIVE, I HAD A VERY DIFFERENT INTERPRETATION OF THIS, I FELT THAT A NUMBER OF THESE EXCLUSIONS WERE PUT IN PLACE TO CLARIFY THINGS THAT WERE NOT REAL CONSIDERED HUMAN SUBJECTS RESEARCH AND THAT DESPITE THE FACT THAT THIS INVOLVE--MAY INVOLVE MANIPULATION OF ENVIRONMENT AND MAY INVOLVE SURVEYS IT WASN'T RESEARCH IN THE SENSE OF GENERALIZABLE KNOWLEDGE AND WHILE THAT MAY BE CLEAR, IF YOU DO THE ANALYSIS, IT CAUSED ENOUGH ISSUES THAT THEY WANTED TO JUST EXCLUDE IT SO THAT WAS CLEAR TO PEOPLE. SO I DIDN'T READ THIS AS PROVIDING AN AVENUE FOR EMERGENCY CLASSIFIED RESEARCH, I READ THAT THE INTENT OF THIS IS NOT TO COVER CLASSIFIED RESEARCH BUT SIMPLY TO MAKE CLEAR THAT IN GENERAL--GENTLEMEN INTELLIGENCE ACTIVITIES AND DATA COLLECTION DESPITE THE FACT THAT THERE WAS INTERACTION AND DATA COLLECTION WAS NOT RESEARCH. >> OKAY, THERE'S BEEN A REQUEST FOR JERRY, IF YOU WOULD--ANY COMMENTS ON THIS DEBATE? >> I THINK I PRETTY MUCH AGREE WITH STEVEN'S TAKE ON THIS, I DON'T THINK THERE IS INTENDED TO CHANGE MUCH. >> ALL RIGHT, SO I'M GOING TO MAKE THE FOLLOWING PROPOSAL AND SEE WHERE THAT GOES. >> MAYBE WE WANT ANOTHER CATEGORY. A CATEGORY OF EXCLUSIONS WE DON'T WANT TO COMMENT ON BECAUSE WE DON'T HAVE THE EXPERTISE OR PACK GROUND, MING BUT WE WANT TO COMMENT TO THE EXTENT THAT THERE'S PUBLIC CONCERN ABOUT THIS ISSUE AND THERE PERHAPS NEED TOS TO BE GREATER PUBLIC CLARIFICATION OF THE INTENT AND SCOPE OF THIS PROPOSED EXCLUSION. THAT CHAIRMANS A BIT OF EVERYARCHING STRUCTURE AND THAT GIVES US FOUR CATEGORIES RATHER THAN THREE. >> BRIE AMBLE PARAGRAPH ON THIS ONE, THE--LAW LAWFUL CONDUCT OF THE DEPARTMENTS AND AGENCIES MANDATED MISSION, FAR ACTIVITILY PROTECTING NATIONAL ISY CURITY, HOMELAND SECURITY OR HOME LAND DEFENSE, OR HOME LAND RESEARCH, THIS ACTIVITIES MAY INCORPORATE THE COLLECTION AND ANALYSIS OF IDENTIFIABLE INFORMATION BUT NOT CONTRIBUTED TO F GENERALIZABLE KNOWLEDGE BUT SOLELY CONDUCTED TO FILL A DEPARTMENT OR AGENCIES LEGAL MANDATE TO INSURE THEIDATE AND PROTECTION OF THE UNITED STATES, ITS PEOPLE AND NATIONAL SECURITY. THIS EXCLUSION CODIFYS THE CURRENT INTERPRETATION OF THE CURRENT RULE, RESEARCH IS CONDUCTED BY FEDERAL AGENCIES OR AGENCIES USING THIS EXCLUSION WILL CONTINUE TO BE SUBJECT TO THIS REGULATION. >> OKAY. EXCELLENT HELP THERE. WHAT ARE FOLKS THINK BEING THIS NOW? SHOULD WE JUST--WHERE DO WE WANT TO GO WITH THIS? >> I WOULD LEAVE THIS IN AS SOMETHING WE SUPPORT, I THINK THE PREAMBLE MAKES IT CLEAR THAT THE ACTIVITIES THAT WE HEARD DESCRIBED AND HEARD AS THE OBJECTIVE PUBLIC CONCERN ARE EXPLICITLY NOT IN THIS ACCORDING TO WHAT JERRY JUST READ. >> OKAY, OTHER THOUGHTS. >> I PREFER WHAT YOU SUGGESTED EARLIER, JEFF. HAVING A FOURTH CATEGORY, OF NONSPECIFIC INFORMATION. >> I'M WITH HOLLY ON THAT. >> SOME GENERAL--I DON'T THINK THIS IS A BIG ISSUE BUT I WOULD AT LEAST LIKE TO BE RESPONSIVE TO PUBLIC CONCERN HERE TO THE EXTENT THERE DOES SEEM TO BE A THEME OUT THERE AND GIVEN THE RECENT HISTORY FOR THE COUNTRY, THERE SEEMS TO BE SOME WORRY THAT THIS MAY BE EXTENDING CAPABILITIES BEYOND WHAT THAT PARTICULAR PARAGRAPH SAYS, SO,-- >> KIDRAFT SOMETHING OVER LUNCH. >> SO LET'S PUT OFF ANY FINAL DECISION ABOUT THAT AND SEE IF WE CAN CRAFT GOOD LANGUAGE, BUT EVERYBODY WOULD BE COMFORTABLE OF PUTTING THIS IN A FOURTH CATEGORY OF WE'RE NOT SURE ENOUGH, BUT ET CETERA. ALL RIGHT, MOVING ON THE. LET THE NEXT ONE IS 101 B-ONE, AND THIS IS THE EKDZ CLIEWGZS APPLIES TO DATA COLLECTION, ANALYSIS, INCLUDING THE USE OF BIOSPECIMENS FOR INSTITUTION'S OWN INTERNAL OCHEERATION AT MONITORING AND PROGRAM IMPROVEMENT. IF THE DATA COLLECTION USE THE DATA BIOSPECIMENS ORIGINALLY COLLECTED FOR THOSE ACTIVITY, AND IS OBLIGATIONS STAINED THROUGH ORAL WRITTEN AND COMMUNICATIONS WITH INDIVIDUALS SUCH AS SURVEYS OR INTERVIEWS. AND THE ONLY THING WE RECOMMENDED LAST TIME WAS THAT WE ADD AND QUALITY HERE TO MAKE IT CLEAR THAT IT CAN BE QUALITY. OTHERWISE [INDISCERNIBLE]. THE. >> SO I JUST WANT TO SAY THAT I AM NOT SURE I UNDERSTAND WHAT THE LIMITS OF THIS ARE BECAUSE IF YOU LOOK AT THE DEFINITIONS, THE DEFINITION OF EN--STRATEGIES TUITION IS NOT PARTICULARLY ENLIGHTENING AND SO, I WAS JUST WONDERING, SUPPOSE YOU'RE LIKE A BIG HEALTH PLAN WITH, YOU KNOW MANY DIFFERENT SITES FOR HEALTHCARE DELIVERY, YOU COUNT AS LIKE AN INSTITUTION, SO LIKE WHAT IF YOU ADD HEALTH SITES HEALTHCARE DELIVERY AND MINNESOTA AND ARIZONA ARIZONA BUT IT'S PART OF THE SAME MAIL OR WHATEVER ISSUES IT WASN'T CLEAR WHAT COUNTED AS AN INSTITUTION AND I FRANKLY I THINK THERE'S A HUGE PUSH FOR PEOPLE TO SHARE DATA ACROSS INSTITUTIONS FOR QUALITY IMPROVEMENT PURPOSES AND SO I JUST--YOU KNOW, I THINK I COULD SAY MY INSTITUTION OWN INTERNAL MONITORING REQUIRES ME TO SHARE DATA WITH OTHER PEOPLE OR AT LEAST ONE COULD MAKE THAT ARGUMENT SO I WASN'T REALLY CLEAR WHAT THE LIMITS ON THIS ARE. >> THERE'S A SEPARATE EXCLUSION RECOMMENDED FOR IMPROVEMENT THE ACTIVITIES AND THE INSTITUTION WILL BE A LEGAL DEVELOPMENTAL ENDOCRINOLOGY CISION AND AN INNS TUITION THAT SOMEBODY THERE HAS LEGAL AUTHORITY TOO. >> IT COULD BE MULTISTATE BUT IT COULD BE A SINGLE INSTITUTION. >> RIGHT, BUT LEGAL ME IT'S GENERALLY AN ORGANIZATION OR ACTIVITIES AND PROJECTS ORGANIZATIONAL ENTITY AND EVEN THERE AND JOINT RESEARCH AGREEMENTS OR OPERATION AT AGREEMENTS LIKE THAT DOES THAT MAKE YOU AN INSTITUTION OR NOT. IS THAT A BROADER ISSUE FOR THE WHOLE ENTERPRISE HERE AND I DON'T KNOW IF WE NEED TO TACKLE THAT IN THIS PARTICULAR EXCLUSION, IF THERE'S A VAGUE NOTION OF WHAT IT SEEMS TO BE A PRETTY OVERARCHING PROBLEM BEYOND THIS EXCLUSION. AND I GUESS DID IS THAT MAKE IT A HUMAN SUBJECT CONCERN OR NOT IF THERE'S SOME ELEMENT OF UNCERTAINTY THERE. >> SO I THINK THIS ONE IS FINE AND WE CAN MOO OF ON TO THE NEXT ONE. >> PILLAR YOU WANTING TOAD SOMETHING TO THIS OR ARE YOU RAISING GENERAL CONCERN FOR THE LACK OF SPECIFICITY. >> I GUESS, YOU KNOW, I WOULD PREFER IT. IF THERE WAS SOME ADDITIONAL EXPLANATION EITHER IF THERE WAS AN ACTUAL REAL LIKE MORE DEFINITION INSTITUTION IN THE DEFINITION SECTION OR IF IT WAS INCLUDED IN HERE, SOMETHING ABOUT, YOU KNOW HERE AND INSTITUTION REFERS TO REFERS TO, YOU KNOW A SINGLE LEGAL ENTITY EVEN IF IT MIGHT HAVE MULTIPLE SITES OR SOMETHING LIKE THAT. >> I MEAN DOESN'T THE WORD INSTITUTION OCCUR THROUGHOUT THE RULE,. >> IT DOES-- >> HOW IS THIS PROBLEM DIFFERENT? >> BUT I THINK THAT PRACTICES HAS CHANGED SO MUCH THAT THIS HAS BECOME AND THERE IS PRESSURE TO SHARE ACROSS INSTITUTION AND THEN THE ORGANIZATION OF HEALTHCARE DELIVERY AND I THINK WITH WHEN THE CURRENT COMMON RULE WAS WRITEN THIS MIGHT NOT HAVE RAISED AS MANY QUESTIONS FOR ME-- >> SO PILLAR CAN I SAY THAT I'M INVOLVED IN MY DAY JOB PRETTY OFTEN IN NEGOTIATES CONTRACTS BETWEEN INDEPENDENT INSTITUTIONS AND IRBs AND WE DON'T HAVE MUCH TROUBLE WITH IT. >> I MEAN YOU GET THE HEALTH SYSTEMS, COMPLEX AND THERE'S A LOT OF LEGAL PRESIDENT FOR WHAT AN INSTITUTION. >> IT'S LIKE MY UNIVERSITY AND YOUR UNIVERSITY, MY UNIVERSITY AND SOME PRIVATE COMPANY AND ACTUALLY I WAS THINKING ABOUT MY OWN, YOU KNOW AT THE UNIVERSITY OF WISCONSIN, WELL, OUR HEALTHCARE DELIVERY SYSTEM AND THE VAHOSPITAL WHICH IS LEGAL HE NOT PART OF OUR INSTITUTION AND SO WE HAVE TO MAKE INSTITUTIONAL AGREEMENTS EVEN THOUGH WE'RE LIKE IN THE SAME BUILDING BASICALLY. RIGHT AND ENTITIES PER HAPPYS WITHIN OUR EN--STRATEGIES TUITION ARE NOT AND IT'S NOT ALWAYS CLEAR TO ME. SO, AND WHEN I'M TRYING TO UNDERSTAND WHAT IT MEANS TO BE PART OF MY INSTITUTION AND THE REASON THIS RAISES ISSUES FOR ME IS BECAUSE THERE ARE POSSIBILITIES FOR A LOT OF DATA SHARING THAT THAT PEOPLE WOULD NOT EXPECT. >> SO THERE'S AN FWA AND EVERY INSTITUTION HAS AN FWA AND YOU GO TO THE FWA AND YOU HAVE AN INSTITUTION. >> I KNOW IT'S DEFINED BUT I DIDN'T FIND THAT DEFINITION VERY HELPFUL. >> SHALL I GO ON. >> ALL RIGHT, NOW WE'LL GO TO AN EASY ONE. >> 101 B-ONE APPLIES TO ORAL HISTORY, JOURNALISM AND HISTORICAL SCHOLARSHIP ACTIVITIES, THAT FOCUS DIRECTLY ON SPECIFIC INDIVIDUALS ABOUT WHOM THE INFORMATION IS COLLECTED AND HERE WE MADE A RECOMMENDATION THAT THIS BE MODIFIED EITHER IN THE REGULATORY LANGUAGE OR THROUGH GUIDANCE AS TO WHAT THAT PHRASE MEANS THAT FOCUS DIRECTLY ON THE SPECIFIC INDIVIDUALS ABOUT WHOM THE INFORMATION IS COLLECTED. IS THAT AN ADDITIONAL QUALIFIER, OR IS THAT A STATEMENT ABOUT THESE FOUR ACADEMIC DEPARTMENTS AS A WHOLE. ARE THEY EXCLUDED AS A WHOLE OR EXCLUDED ONLY IF THEY'RE CONDUCTING SPECIFIC RESEARCH ON THOSE INDIVIDUALS AND WE FELT THAT WAS UNCLEAR. AND THE PROPOSAL THAT CAME OUT LAST TIME, I WAS BT SO SURE, I HAD TO READ IT WAS TO SAY THAT ORAL HISTORY JOURNALISM AND BIOGRAPHY AND HISTORICAL SCHOLARSHIPS WHO COLLECT AND SHARE EVIDENCE BASED PORTRAYALS OF INDIVIDUALS WHO THEMSELVES HAVE BEEN SELECTED AS A RESULT OF THE RELEVANCE OF THEIR PERSONAL EXPERIENCE TO THE PHENOMENA BEING STUDIED. >> I WOULD RECOMMEND THE FIRST LINE TO BE ORAL HISTORY JOURNALISM AND BIKING ONOGRAPHY AND HISTORICAL THIS PURPOSE IS TO COLLECT. >> IT STILL SEEMS TO ME BY LISTING ONLY ONE, TWO, THREE, FOUR FIELDS THERE IS AN OPPORTUNITY FOR SOME PARTICULARLY RESTRICTIVE FOLKS TO FEEL THAT ONLY THOSE FOUR FIELDS ARE THE ONES THAT ARE EXCLUDED. >> MAYBE SOME WORD SMITHING HERE, IS THE WORD THEMSELVES NECESSARY? >> OKAY, DISCUSSION OF THIS? >> OKAY, THANK YOU. I'LL ADD THAT. >> OKAY, THE IN TEXT ONE IS THE ETIONDZ CLIEWGZ AT 101 B-1, ROM ANET FOUR, FOR QUALITY ASSURANCE OR PROVEN ACTIVITIES INVOLVING IMPLEMENTATION OF ACCEPTED PRACTICE TO IMPROVE QUALITY OF CARE OR SERVICES INCLUDING BUT NOT LIMITED TOO EDUCATION, TRAINING, PROCEDURE TO CARE SERVICES IF THE PURPOSES ARE LIMITED TO ALTERING THE UTILIDESSATION OF THE ACCEPTED PRACTICE OR ACCEPTING DATA FOR BIOSPECIMENS TO BIOEFFECTS ON ACCOUNT PRACTICEIS, THIS EXCLUSION DOES NOT COVER THE EVALUATION OF AN ACCEPTED PRACTICE ITSELF. >> SO THERE WAS A LOT OF CONCERN AT BOTH LEVELS SUBCOMMITTEE HERE ABOUT THAT YOU CAN'T EVALUATE THAT OR THE FACT THAT THAT WOULD BE UNDULY LIMITING FACTOR. SO THE PROPOSAL AT LINES 121-127, I WILL READ IT, IF YOU THINK IT COVERS BETTER ADDRESSES THAT PARTICULAR ISSUE. >> QUALITY ASSURANCE OR PROVEN ACTIVITIES ACCEPTED PRACTICE IN ORDER TO IMPROVE THE DELIVERY OR QUALITY OF CARE OR SERVICES INCLUDING BUT NOT LIMITED TOO EDUCATION, TRAINING, PROCEDURES OR CARE OR SERVICES, IF IF THE PURPOSES ARE LIMITED TO IMPLEMENTING THE ACCEPTED PRACTICE AND COLLECTING DATA OR SPECIMENS TO EVALUATE THE EFFECTS ON PROCESS AND OUTCOMES RELATED TO ITS IMPLEMENTATION, THIS MAY INCLUDE COMPARING STRATEGIES FOR IMPLEMENTATION OF ACCEPTED PRACTICE BUT DOES NOT COVER THE EVALUATION OF PRACTICES NOT WITHIN THE RANGE OF ACCEPTED PRACTICES OR DIRECT COMPARISONS OF ACCEPTED PRACTICES THEMSELVES. >> SO WITH THIS EXCLUSION, A RANDOMIZED STUDY COMPARING FOR INSTANCE DIFFERENT METHODS OF CONTROLLING NOTICES OF COPIAL INFECTIONS BY FOR INSTANCE USING AN ANTIBACTERIAL VERSUS SCRUBBING THE SURFACE OF THE HOSPITAL ROOM, ET CETERA? >> I THINK IT COULD, DEPENDING ON WHAT DATA YOU WERE COLLECTING AND WHAT YOU'RE INTENDING TO PROVE. >> I GUESS THAT'S THE QUESTION FYOU'RE NOT INTENDING TO PROVE SOMETHING ABOUT THE PRODUCTS THEMSELVES, BUT IF YOU'RE SAYING, HEY, WE WILL IMPLEMENT THIS IS MEASURE IT. >> I THINK IT'S SUPPOSED TO. I-- >> SORRY, IF IT DID THEN, THIS IS RANDOMIZED RESEARCH AND SHOULD NOT BE EXEMPTED UNDER ANY PLACE? DISMRKS MY READ OF THIS IS THAT IT SHOULDN'T COVER SOMETHING LIKE THAT. THAT IT'S, THE QUESTION YOU WOULD BE ASKING THERE IS MORE EFFECTIVE THAN REDUCES INFECTION BUT IT WOULD COVER A RANDOMIZED TRIAL THAT WOULD SAY WE KNOW ANY BACTERIAL SOAP IS A GOOD THING AND WE HAVE TWO STRATEGIES TO MAKE PEOPLE WASH THEIR HANDS AND WE WILL SEE WHERE ONE RANDOMIZED GROUP WASH THEIR HANDS THIS WAY AND ANOTHER ONE WASH THEIR HANDS ANOTHER WAY AND WE WILL SEE WHICH MAKES PEOPLE WASH THEIR HANDS MORE AND THEN AS AN OUTCOME, I GUESS WHAT WE'RE TRYING TO SAY IS YOU COULD THEN MEASURE INFECTION RATE AS A SECONDARY OUTCOME WHAT THE HYPOTHESIS IS, AND YOU DON'T KNOW WHICH IS BETTER IN REDUCING INFECTION AND I THINK YOU'RE OUT AND I THINK THAT'S CORRECT. THAT'S HOW HOW I INTERPRET THIS, THE EXPLICIT INTENT IS NOT NOT HAVE COMPARATIVE RESEARCH IN THE INCLUSION. >> I WOULD TO SAY, I TOTALLY AGREE, BUT THERE IS OBVIOUSLY A GREAT DISCUSSION GOING ON NOW ABOUT WHETHER COMPARATIVE EFFECTIVENESS, RESEARCH SHOULD OR SHOULD NOT BE COVERED AND I THINK WE JUST HAVE TO CHOOSE OUR WORDS VERY CAREFULLY BECAUSE HOWEVER, WE READ IT, PEOPLE ON BOTH SIDES OF THAT DEBATE WILL SEEK THEIR OWN INTERPRETATION. THAT'S WHY I LIKE THE FIRST UNQUALIFIED VERSION BETTER. I THINK IT'S CLEAR WHAT THE INTEND IS, I THINK THE ADDED LANGUAGE ACTUALLY GIVES WIGGLE ROOM FOR INTERPRETATIONS THAT WERE NOT INTENDED OR I DON'T THINK WERE INTENDED. >> I GUESS I HAVE TO DISAGREE THOUGH BECAUSE I THINK THAT WE WANT TO BE ABLE TO COLLECT THAT SECONDARY OUTCOME DATA AND I THINK THE RIGID READ OF THE FIRST ITERATION IS THAT, OKAY, EACH IF THAT'S INCLUDED IN A SECONDARY OUTCOME DATA, YOU CAN'T DO THAT STUDY, QI STUDY OUTSIDE OF THE IRB. AT LEAST THAT'S WHAT I'VE HEARD DISCUSSED IN MY OWN INSTITUTION AND I THINK THAT WOULD BE TOO NARROW. SO UNLESS IT CAN BE DONE THROUGH GUIDANCE IN SOME WAY, I THINK IT DOES--I AGREE THAT WE WANT TO KEEP COMPARATIVE EFFECTIVENESS RESEARCH OUT OF THIS SO WE WANT TO ALLOW PEOPLE TO STUDY AS A SECONDARY OUTCOME THE EFFECTIVENESS. >> SO I THINK IF WE MAKE IT CLEAR THAT CAN YOU STUDY THE OUTCOME, I MEAN I THINK WHAT I LIKE ABOUT THE FIRST ONE IS THE EXCLUSION DOES NOT COVER THE EVALUATION OF THE FACT THAT THEMSELVES, IT DOESN'T SAY TO ME THAT YOU CAN'T MEASURE THE OUTCOMES. I MEAN HOW COULD--ANYWAY, BUT I UNDERSTAND YOUR POINT AND I THINK IT JUST GOES THAT WE HAVE TO FIND LANGUAGE THAT MAKES THIS CLEAR. >> SO, FIRST OF ALL, STEVE AND I TOTALLY AGREE WITH YOU AND I THINK PERHAPS SACHRP SHOULD JUST SAY THAT OHRP NEEDS TO DEVELOP GUIDANCE TO CLEARLY EXPLAIN THAT COMPARATIVE EFFECTIVENESS RESEARCH DOESN'T FALL WITHIN THIS, BUT THAT COLLECT THANKSGIVING OUTCOME DATA AS SECONDARY END POINTS IN EXCLUDED RESEARCH WOULD BE ACCEPTABLE, RIGHT? I MEAN I THINK THAT'S HOW TO HANDLE THIS BECAUSE I AGREE. I KIND OF LIKE THE ORIGINAL LANGUAGE A LITTLE BIT BETTER. >> IF I COULD ADD ONE MORE PIECE, I FORGOT TO READ THIS OFF, ONE LAST THING WE RECOMMEND OR SUGJUSTED LAST TIME WAS THAT THE CURRENT OHRP ON FAQs BE LEFT POSTED FOR EXAMPLE SO THEY PROVIDE EXAMPLES AND KEEP IN MIND, IF THAT'S WHAT OCCURS. >> SO LET'S JUST ALL MAKE CLEAR THE DISCUSSION DOES OCCUR POTENTIALLY CONFUSING LANGUAGE IN THE NPRM AND THAT AND THAT WE HAVE GREATER CLARITY SO MY QUESTION IS, IF THERE'S DEBATE OVER OR ALTERNATIVE TO WHAT EXTEND DO WE HAVE TO PUT FORWARD IN A LANGUAGE IF WE DESCRIBE THE NATURE OF THE PROBLEM AND SAY, THIS NEEDS TO BE CLARIFIED RATHER THAN BLOCKING OURSELVES INTO THE SPECIFIC ALTERNATIVE LANGUAGE. >> THIS IS ONE COMMENT. 117 TO ACCEPTABLE TO COLLECT INFORMATION THAT CAN BE USED TO EVALUATE THE EFFECTIVENESS OF THE PRACTICE ITSELF. >> SO I WANT TO SAY YOUR PROPOSAL OF OFFERING ALTERNATIVE LANGUAGE, BECAUSE I THINK ANY LANGUAGE THERE WILL RAISE A LOT OF QUESTIONS BECAUSE THIS IS A MATTER OF OF PRETTY FINE LINE DRAWING. AND THAT'S WHAT I THINK ACTUALLY GUIDANCE DOCUMENT WITH EXAMPLES IS GOING TO BE NEEDED NO MATTER WHAT. AND PERHAPS THE REGULATION OF ITSELF COULD BE CLEAR BUT I SUSPECT THERE WILL NEED TO BE GUIDANCE SO I DON'T THINK WE SHOULD LOCK IN THE LANGUAGE. I GUESS MY ONLY HESITATION IS THAT THERE'S A TIMELINE, I DON'T KNOWLEDGE KNOW IF WE'RE GOING TO COME UP WITH THE LANGUAGE PERFECTLY, I HAVE INVESTIGATORS THAT THINK EVERYTHING THEY DO IS IMPROVE QUALITY, BECAUSE ALL I WANT TO DO IS IMPROVE QUALITY OF CARE. THAT MAY BE A QUESTION FOR JERRY, WHAT'S WILL HAPPEN WITH THE FINAL RULE? WILL THERE BE GUIDANCE AT THE TIME IT COMES OUT OR DO YOU ANTICIPATE THAT WILL TAKE TIME? >> I DOUBT THERE'S GUIDANCE BUT THE TIME THE TYPAL RULE COMES OUT FOR WHAT IT'S WORTH, THE LANGUAGE YOU HAD IN THERE, AT LEAST IN TERMS OF OHRP, WE WOULD NOT FIND THAT ACCEPTABLE. SOUTH AMERICA AGAIN IT'S QUESTIONS THAT PEOPLE HAVE RAISED, IT'S ALLOWING PEOPLE VYING FOR RESEARCH TO BE EXCLUDED. LOOKING AT THE LAST EXAMPLE FOR, THIS MAY INCLUDE EXEMPTING EVALUATION OF PRACTICE, DOES NOT COVER PRACTICES IN THE RANGE OF ACCEPTED PRACTICES SO IT WOULD SUGGEST IT COVERS EVALUATION OF PRANTHISS WITHIN THE RANGE OF ACCEPTED PRACTICES. SO I DON'T KNOW THAT SEEMS TO ACTUALLY BE EXCLUDING A WHOLE PUNCH OF STUFF THAT PEOPLE CERTAINLY ON OUR END CONSIDER TO BE CLINICAL RESEARCH THAT SHOULD BE SUBJECT TO THE COMMON RULE, HAVE YOU A ONE-ARMED TRIAL. LET YOU'RE ASSIGNING EVERYBODY TO A PARTICULAR PRACTICE THAT IS A CURRENT ACCEPTED PRACTICE, BUT YOU'RE AT AN INSTITUTION WHERE ACTUALLY A NUMBER OF THESE KIND OF ACCEPTED PRACTICES THAT'S A VERY DIFFERENT PURPOSE THAN THE STARTING POINT OF THAT PROVISION WHICH IS ABOUT DOING AN INITIATIVE TO ENCOURAGE THE USE OF A PARTICULAR PRACTICE. SO IT'S RAISING ENOUGH ISSUES AND AMMUNITION FOR SOMEBODY WHO DRAMATICALLY WANTS TO EXPAND THIS, TO COVER RESEARCH THAT FROM OUR VIEW POINT CLEARLY SHOULD BE UNDER THE COMMON RULE. I THINK SIMILAR NUMBER OF COMMENTS THAT WERE MADE, THAT'S WHY THE DRAFT MADE IT VERY CLEAR. IT SHOULDN'T BE ABOUT EVALUATING THE PRACTICE AND THE PRACTICE ITSELF AND IT'S CLEAR IN OTHER DISCUSSIONS ABOUT THE USE OF SECONDARY DATA ASSUMING YOUR DESIGN WAS INTENDED TO LOOK AT THE IMPLEMENTATION OF THE PRACTICE BUT THE REVISED LANGUAGE SEEMS TO GO IN A VERY DIFFERENT DIRECTION. >> SO IN TERMS OF JONATHAN'S EXAMPLE, IF ONE WERE COMPARING STRATEGIES TO IMPROVE HAND WASHING, HAND WASH SUGGEST A GOOD THING BUT YOU WANT TO COLLECT INFECTION RATES ON THOSE TWO DOMAINS ANYHOW, THAT IN IT OF ITSELF WOULD NOT KICK IT INTO A NONEXCLUDED CATEGORY. >> YEAH, AGAIN AND OBVIOUSLY A LOT OF THIS WOULD HAVE TO COME OUT IN TERMS OF GUIDANCE, COULD SYRUPLY, THIS RULE LIKE ANY OTHER RULE COULD BE MANIPULATED BY SOMEBODY TRYING TO--CREATING A STUDY THAT SOUNDS AS IF IT'S DESIGNED TO LOOK AT IMPLEMENTATION BUT ACTUALLY THEY'RE USING IT INDIRECTLY AS A ROUTE TO ACTUALLY COLLECT INFORMATION ABOUT HOW EFFECTIVE YOU KNOW ARE THE RISKS OF THE ACTUAL ACCEPTED PRACTICE THAT YOU'RE STUDYING BUT THOSE ARE THINGS YOU HAVE TO DEAL IN TERMS OF GUIDANCE BUT WE HAVE HIDDEN THE RESPONSE TO THE COMPLAINT THAT YOU WOULDN'T BE ABLE TO ACTUALLY ANALYZE DATA THAT YOU GENERATED ABOUT THE PRACTICE, NO, THAT'S FINE, AGAIN ASSUMING YOUR STUDY REALLY MEANT WHAT THIS THING WAS ABOUT AT ITS CORE WHICH IS ABOUT LOOKING AT IMPLEMENTATION AND SOME STUDY INCLUDING RESEARCH TO LOOK AT IMPLEMENTATION. >> ALL RIGHT, SO LET ME GO BACK TO THE PRIOR THOUGHT THAT WHAT OUR RECOMMENDATION SHOULD BE IS GREATER CLARITY AND GUIDANCE ON THIS EXCLUSION AND THAT WE SHOULD NOT OURSELVES PROPOSE ALTERNATIVE LANGUAGE BECAUSE I DON'T THINK WE--THAT CONSENSUS THAT WE'VE GOT THE ALTERNATIVE LANGUAGE RIGHT. >> SO THEN IS IT FAIR TO SAY WE DROP THE LANGUAGES ON LINES 141-5160 DUE TO THE FACT THAT IT'S RESTRICTIVE THAT DATA THAT LENDS ITSELF FOR EVALUATION AND ACCEPTED PRACTICE ITSELF. IT SOUNDS LIKE WE'RE MOVING AWAY FROM THAT. THAT WAS A SUBCOMMITTEE. >> WELL IT SEEMS TO ME THAT'S STILL THE CONCERN MAYBE IN WHAT THE ISSUE IS, WITH JERRY'S CLARIFICATION HERE IS NOT SO MUCH HOW OHRP IS CURRENTLY INTERPRETING THE PROPOSED NEW LANGUAGE BUT HOW THE COMMUNITY MAY BE INTERPRETING THAT AND WITH THE RISK OF OVERINTERPRETATION OF WHAT THE INTENT IS HERE, DUE TO CONCERNS THAT THE PROPOSED WORDING IS EITHER TOO RESTRICTIVE OR WILL BE INTERPRETIVE IN TOO RESTRICTIVE OF A FASHION MIGHT BE AN ADDITIONAL CLAUSE REGARDING THE COLLECTION OF DATA. >> AND THEN DROP THIS LANGUAGE, YEAH. >> YES. >> SO THAT PROBABLY LAST STATEMENT. >> OKAY, SO HOW THIS LOOK TO FOLKS? >> OKAY, I THINK WE'RE GOOD. >> DO YOU WANT MOOY TO POLISH IT UP A BIT OVER LUNCH. >> OKAY. >> THEN WE GET TO EXCLUSIONS THAT SHOULD NOT BE ADOPTED AND BASICALLY JUST TO CUT THE CONVERSATION A LITTLE SHORT. BASICALLY ALL OF THE B-TWOs, B-ONE, B21, THREE, AND FOUR, THE RECOMMEND ANTICIPATION WAS THAT THESE NOT BE LEFT AS EXCLUSIONS, THEY DON'T PROVIDE ADEQUATE PROTECTIONS AS EXCLUSIONS AND THEY ALL BE MOVED TO EXEMPTIONS. SO THE FIRST ONE IS RESEARCH NOT INCLUDING INTERVENTIONS THAT INVOLVES THE USE OF EDUCATIONAL TESTS, SURVEY PROCEDURES OR OBSERVATIONS OF PUBLIC BEHAVIOR, UNINFLUENCED BY THE INVESTIGATORS IF ONE OF THE FOLLOWING CRITERIA IS MET, RECORDED IN SUCH A MANNER NOT BE IDENTIFIED OR DIRECTLY TO IDENTIFIERS WITH THE SUBJECTS, ANY DISDOSURE OF THE SUBJECTS OUTSIDE THE RESEARCH AND/OR ANY DISCLOSURE OF HUMAN SUBJECTS RESPONSES OUTSIDE THE RESEARCH WOULD NOT REASONABLY PLACE THE SUBJECTSA CRIMINAL OR CIVIL LIABILITY DAMAGING TO FINANCIAL STANDING AND EMPLOYEE ADVANCEMENT OR REPUTATION, SO THE EDSICATION ADVANCEMENT IS IN ADDITION TO THE CURRENT B-TWO LANGUAGE, VERY SIMILAR OR C, RESEARCH WILL INVOLVE A COLLECTION OF INFORMATION SUBJECT TO THE PAPERWORK REDUCTION ACT OF 1995, RESEARCH INFORMATION WILL MAINTAIN SUBJECT TO AND COMPLIANCE AND SECTION 208 B GOVERNMENT ACT. AND ALL THE INFORMATION MAINTAINED WITH THE SYSTEM OR SYSTEMS OF RECORD SUBJECT TO THE PRIVACY. WE THOUGHT THIS LEFT TOO MUCH UPON DISCRETION TO AN INVESTIGATOR IN A WAY THAT MIGHT BE REPORTED. >> SO THE DISCRETION RATIONAL BOTHERS ME A LITTLE BIT AND I GUESS, I'M NOT CERTAIN I UNDERSTAND REALLY WHAT THE CONCERN IS, ESPECIALLY IN LIGHT OF THE DISCUSSION YESTERDAY WITH REGARD TO BIOSPECIMENS AND REIDENTIFICATION OF DEIDENTIFIED SAMPLES, SO TO PUT A PHRASE TO IT, THIS SOUNDS LIKE A CASE OF BIOSPECIMEN RESEARCHER OR EXCEPTIONALISM, BECAUSE THERE THE ASSUMPTION, THE UNDERLYING ASSUMPTION IN THE SANCTIONS CLAUSE THAT WE ADDED WAS THAT MOST PEOPLE WOULD BEHAVE WELL BUT SOMEBODY MIGHT BEHAVE POORLY AND THOSE PEOPLE SHOULD BE SANCTIONED FOR POOR BEHAVIOR AND THAT'S REIDENTIFICATION OF DEIDENTIFIED GENETIC SAMPLES. IN THIS CASE, WE'RE MAKING THE OPPOSITE ASSUMPTION,ERB MIGHT BEHAVE POORLY SO WE'RE NOT ALLOWING THE EXCLUSION. >> I DON'T THINK THAT THE ISSUE OF DISCRETION HAS TO DO WITH BEHAVING POORLY, IT HAS TO DO WITH WHAT I SEE AS A REALLY BIG DIFFERENCE BETWEEN EXCLUSIONS AND EXTENSIONS. THAT IS AN EXCLUSION REQUIRES ABSOLUTELY NO OVERSIGHT, NO PAPER TRAIL NO ANYTHING AND IN THINGS THAT ARE USE OF SUBJECT RESEARCH, THE USE OF THE TOOL REQUIRES THE INVESTIGATES TO GO THROUGH A THOUGHT PROCESS AND NOT THAT THEY'RE TRYING TO GET AROUND THINGS ABOUT YOU THAT IN THESE CATEGORIES, THERE ARE THINGS THAT INVESTIGATORS NEED TO THINK THROUGH AND MIGHT BENEFIT FROM SOME ASSISTANCE IN THINKING THROUGH, AND THERE THEN IS A RECORD THROUGH THE COMPLETION OF EXEMPTION TOOL THAT THIS PARTICULAR RESEARCH HAS BEEN DEEMED EXEMPT. >> I APPRECIATE THAT, I WAS TRYING TO GET AN ANSWER TO A QUESTION THAT I HAD THAT WAS RELATED TO THIS DISCUSSION WHICH WAS IN WHAT WE DISCUSSED YESTERDAY WITH REGARD TO BIOSPECIMEN, IS THERE ANY CASE IN WHICH A BIOSPECIMEN RESEARCH, EITHER WITH A BIOSPECIMEN OR WITH THE DATA DERIVED WAS THAT IT WAS COLLECTED UNDER CONDITIONS OF NOTIFICATION AND OPT OUT AS WE DISCUSSED AND THAT THE BIOSPECIMEN OR THE DAT WERE DEIDENTIFIED IS THERE ANY CASE WHERE THAT RESEARCHER CAN DO RESEARCH ON THAT MATERIAL EITHEROT BIOSPECIMEN OR DAT WITHOUT TALKS TO AN IRB SO I POSE THAT TO SEVERAL PEOPLE AND NOBODY COULD GIVE ME A CLEAR ANSWER. IF IT'S THE CASE THAT THAT RESEARCH COULD OCCUR, THEN THAT'S EXCLUDED. >> THERE WAS ONE EXCLUSION ON DATA THAT YOU ALREADY KNEW ABOUT THAT PERSON. >> ELABORATE FOR THE DISCUSSION? >> THIS WAS A PROVISION WE DISCUSSED IN THE LAST MEETING WHERE IF YOU'RE DOING RESEARCH ON BIOSPECIMENS AND YOU ALREADY KNOW THE INFORMATION ABOUT THE PERSON, YOU WANT CANCER TISSUE SAMPLES TO DO FURTHER RESEARCH ON CANCER, THEN THAT DID NOT--THAT COULD BE EXCLUDED. >> I DON'T KNOW WHAT THE RIGHT PRACTICAL ANSWER AND I THINK--I RESPECT THE INTENT. THE OTHER EXCLUSION THAT WE DISCUSSED PREVIOUSLY ARE ALL EXCLUSIONS BECAUSE THE PURPOSE IS TO CLARIFY THIS IS NOT RESEARCH, PEOPLE MAY BE CONFUSED ABOUT IT BEFORE BUT THIS IS NOT REASONS, BUT THESE THREE WE'RE PROPOSING BE MOVED INTO FOUR, THAT THE ONES WE'RE PROPOSING BEING MOVED INTO THE EXEMPTION CRITERIA, ARE HUMAN SUBJECTS RESEARCH. THERE'S NO QUESTION ABOUT THAT, AND THERE'S SOME INTELLECTUAL CLARITY AT LEAST IN--IN TERMS OF WHAT IS AN EXCLUSION VERSES AN EXEMPTION. EXCLUSION IS STUFF WE'RE NOT CONSIDERING BECAUSE IT'S NOT RESEARCH. EXEMPTION IS STUFF THAT NEEDS FAR LESS CONTROLS AND DOESN'T NEED THE FULL THING BUT IT'S STILL RESEARCH AND SO I THINK IF WE ADOPT THE PROPOSAL TO MOVE THESE INTO EXEMPTIONS, NOT TO GET RID OF THEM BUT TO MOVE THEM INTO EXEMPTIONS, THEN THAT RESPECT, THAT DISTINCTION AND ACTUALLY PERHAPS CLEARIFYS THE DIFFERENCE BETWEEN EXCLUSIONS AND EXEMPTIONS FOR THAT. >> IT'S ALONG THESE LINES, I WAS GOING TO SAY SOMETHING SIMILAR TO WHAT TOM SAID, ALTHOUGH I,A GHEE WITH THE CONCLUSION, I WOR THAT'S WHAT'S IN THE DOCUMENT IS TOO BARE, WE THINK IT SAY IT GIVES INVESTIGATOR IT IS TOO MUCH DISCRETION FULL STOP, INSTEAD OF EXPLAINING WHAT THE CONCERN IS, THAT THESE ARE COMPLICATED OBJECTIVE DECISIONS THAT WE WANT PEOPLE TO LOOK AT AND THAT'S RATIONAL IS--EACH SAYING, YOU KNOW THAT IT'S ABOUT THE CLARITY BETWEEN WHAT'S RESEARCH AND WHAT'S NOT RESEARCH. SO I AGREE WITH WHAT WE'RE SUGGESTING TO DO HERE. IS THAT WE SORT OF OWE IT TO THE PUBLIC TO HAVE A MORE ROBUST EXPLANATION OF THE RATIONAL. SO I WOULD AGREE WITH WHAT HOLLY SAID AND I WOULD SAY THAT I DON'T THINK IT'S ABOUT BAD ACTORS BECAUSE, SOMEONE'S REALLY A BAD ACTOR, THEY CAN JUST LIE ABOUT THEIR INTENT OR ANYTHING ELSE, RIGHT? BUT I KNOW IN MY OWN WORK I OFTEN RUN INTO INVESTIGATORS WHO ACTUALLY JUST DON'T KNOW, LIKE THEY DON'T KNOW WHAT THE LEGAL RISKS ARE OF SOMING LIKE THAT AND SO JUST HAVING TO WORK THROUGH A TOOL WHERE IT MIGHT FLAG FOR THEM THAT OH MAY BE I DON'T KNOW AND I SHOULD GO TALK TO SOMEBODY BEFORE I GO FORWARD, RIGHT IS WHAT'S IMPORTANT. >> I DON'T THINK IT'S ABOUT SOMEHOW IMPLYING THAT PEOPLE WHO ARE DOING THESE KINDS OF RESEARCH ARE, YOU KNOW UNTRUSTWORTHY. >> I WELL I APPRECIATE THAT AND I THINK HOLLY HAS IT RIGHT ON THE HEAD THAT THE BEAR DESCRIPTION OF DISCRETION, TOO MUCH DISCRETION IS OPEN TO A VARIETY OF INTERPRETATION, SOME OF WHICH ARE NOT ALTOGETHER FLATTERING, YEAH. >> BUT I THINK PART OF THE DISCUSSION HERE, THE ISSUE HAS BEEN FOLK WHO IS COME FORWARD WITH INSTANCES IN THEIR OWN EXPERIENCE THAT BECOMES THE UNUSUAL CIRCUMSTANCE, BUT YET, AWIVE TIMES TEND TO DOMINATE ARE THINKING ABOUT WHAT THE--WHAT THE WORST CASE CONSIDERATIONS ARE HERE AND WE--YOU KNOW THINK ABOUT THE GRADUATE STUDENT WHO DOESN'T HAVE A WHOLE LOT OF EXPERIENCE AND MAYBE CONDUCTING INTERVIEWS OF PEOPLE WITH SENSITIVE TOPICS FOR WHICH THIS INDICATES THAT THE DEIDENTIFICATION DOESN'T EVEN HAVE TO HAPPEN. THEY JUSTA HAVE TO MAKE A DETERMINE NATION, UNILATERALLY THAT THIS IS UNLOCALIZED PROSTASTILY TO BE PROBLEMATIC FOR INDIVIDUALS SO YOU GET HIGHLY SENSITIVE SORTS OF RESEARCH THAT WOULD WOULD FALL UNDER THIS EXCLUSION THAT I THINK HAS MADE FOLKS A LITTLE NERVOUS ABOUT HAVING NO OVERSIGHT. SO, FROM MY PERSPECTIVE, I THINK THAT'S FRAMING SOME OF THIS,. >> THE FACT THAT IT'S STILL SUBJECT TO THE CLAUSE C THERE REALLY MAKE IT WHERE IT'S GOT THE CONFIDENTIALITY PROTECTIONS, SO, IF YOU'RE SAYING WHAT IF THEY GET IT WRONG, DOES IT MATTER BECAUSE IT'S STILL GOING TO BE UNDER THE APPROPRIATE CONFIDENTIALITY DATA PROTECTION STANDARDS,. >> YOU KNOW I COULD ANSWER THAT QUESTION, I COULD GIVE YOU THE SUBCOMMITTEEEE VIEW AND THE SUBCOMMITTEE'S VIEW WAS THAT THREE OF THESE BASE THE EXES CLIEWGZ ON THE FACT THAT THERE ARE OTHER PRIVACY PROTECTIONS IN PLACE. AND THEIR GENERAL, THEIR MAJORITY SENSE WAS THAT THERE'S MORE--THERE'S MORE RISK INVOLVED IN THESE TYPES OF RESEARCH STUDIES THAN JUST A CONFIDENTIALITY BRIDGE. THAT THERE MIGHT BE PSYCHOLOGICAL HARM. OTHER TYPES OF HARM THAT WOULD NOT BE CONSIDERED UNDER THE APPLICATION OF THE PRIVACY ACT OR HIPAA. >> IT SHOULD ALSO BE THE CASE AND MAYBE I'M OVEROPTIMISTIC THAT A LOT OF THIS WILL HINGE ON THE EXEMPTION TOOL AND IT SHOULD ADDRESS THIS BUT A GOOD EXEMPTION TOOL SHOULD BE ABLE TO DISTINGUISH AMONG WHICH CATEGORIES UNDER ANY PARTICULAR EXEMPTION OR PARTICULAR RESEARCH PROJECT FITS AND THAT WOULD ALLOW FOR APPROPRIATE CONCLUSION. SO A GOOD EXEMPTION TOOL REALLY WILL BE GOOD GUIDANCE. ALSO I THINK THE LANGUAGE THAT THEY HAVE COME UP WITH HERE IS VERY GOOD. >> I GUESS THIS IS--NOT DISAGREEING WITH THE CONCLUSIONS TO MOVE THESE BUT I'M NOT SURE--SO, I HAVE A FUNDAMENTAL DISAGREEMENT WITH THE DISCUSSION OF ALL OF THIS AS HUMAN SUBJECTS RESEARCH ONLY ON A RISK BASIS. SO THE FACT THAT YOU'RE COVERED BY HIPAA FOR CONTROL OF THE SECURITY RISK DOESN'T NECESSARILY MEAN YOU SHOULDN'T CONSENT PEOPLE. SO I MEAN--I WOULD WOULD PREFER TO DISCUSS, I DON'T THINK THESE SHOULD BE EXCLUSIONS AND I THINK EVEN THAT POINT MERITS SOME DISCUSSION UNDER EXEMPTION. I THINK THERE ARE OTHER ASPECTS OF THE RESEARCH THAT IT SHOULD AT LEAST BE CONSIDERED AND YOU KNOW AN IRB CAN GIVE A WAIVER OF OF INFORMED CONSENT BUT AT LEAST IT HAS TO THINK ABOUT THAT WHERE IF IT'S EXCLUDED IT'S OFF THE TABLE AND IT IS DITTO AND I'M NOT SURE THAT JUST BECAUSE WE'VE ADDRESSED THE RISK SIDE, THAT THAT GIVES AN EXCUSE FOR RESEARCH TO BE DONE WITHOUT INFORMED CONSENT BECAUSE PEOPLE ARE PARTICIPATING, NOT JUST ABOUT WHAT THEY RISK THEMSELVES. >> YEAH, I--VERY MUCH AGREE WITH THAT AND THERE'S ACTUALLY SOME LANGUAGE IN THE NPRM THAT REALLY SAYS THAT ABOUT THESE EXCLUDED CATEGORIES AND SO IT MAKES TOTAL SENSE TO MOVE THEM TO EXEMPTIONS AND TO SAY THINGS LIKE CONSISTENT WITH THE SPIRIT OF RESPECT FOR PERSONS INVESTIGATORS SHOULD TELL SUBJEBS WHERE APPROPRIATE THEY CAN CHOOSE TO PARTICIPATE OR NOT IN THESE ACTIVITIES AND ALL OF THAT IS ENCOMPASSED BY THESE CATEGORIES OF RESEARCH. SO I'M NOT EXACTLY SURE HOW TO SAY THAT, BUT WE HAVE TO MAKE THIS IS DEFINITELY NOT THE RISKS OF PHARMA THAT THAT CATEGORY C MAY BE PROTECTIVE ABOUT THE PRIVACY RISK AND THE EXEMPTION TOOL SHOULD TAKE THAT INTO ACCOUNT, THIS IS STILL ABOUT EVERYTHING. >> OKAY, SO IT SOUNDS LIKE WE'RE IN GENERAL AAGREEMENT THAT WE NEED AS DAVID IS DOING HERE ON THE FLY, THE EXPANDING JUSTIFICATION FOR THIS MOVE, IT SOBBEDS LIKE THE GENTLEMEN COMFORT WITH THE NOTION THAT THIS SHOULD BE AN EXEMPTION RATHER THAN EXCLUSION. JERRY? >> JUST AN OVERVIEW COMMENT BECAUSE I THINK THIS GETS BACK TO SOME OF THE ISSUES DISCUSSED YESTERDAY IN TERMS OF LINE DRAWING INTO THE EXTENT DISTINCTIONS ARE MADE OR DIFFERENCES ARE MADE BETWEEN TREATMENT OF BIOSPECIMENS VERSUS TREATMENT OF INFORMATION. I SEE THE POINT BEING MADE IN TERMS OF RESPECTING SOMEBODY'S AUTONOMY, RELATING TO ISSUES BEYOND RISKS BUT IF IN FACT THAT IS A CONCERN, NOTE THAT THE CURRENT RULES TO THE EXTENT, THE USE OF DEIDENTIFIED INFORMATION MEANS YOU'RE NOT USING HUMAN SUBJECTS, I WOULD EXPECT THE SAME CONCERNS WOULD BE OUT THERE, RIGHT NOW YOU COULD USE INFORMATION LEFT AND RIGHT AS LONG AS YOU DEIDENTIFIED IT AND THE EXTENT YOU'RE TALK ABOUT PSYCHOLOGICAL CONCERNS OR ANYTHING ELSE, WHICH I TAKE IT YOU'RE SAYING A PUNISH MIGHT OBJECT TO THIS TYPE OF RESEARCH BECAUSE IT COULD BE, YOU KNOW VALUING THE GROUP OR WHATEVER, EXACTLY WHAT YOU TALKED ABOUT YESTERDAY, THE YESTERDAY THE POINT WAS MADE THAT WITH REGARD TO DEIDENTIFIED BIOSPECIMENS WE'RE PUTTING IN A BUNCH OF PROTECTIONS THAT ARE LOOKING AT THAT AND SOME MIGHT SAY IN A COMPLICATED WAY, AGAIN THERE IS A LINE BEING DRAWN HERE THAT WE'RE NOT DOING THIS WITH REGARD TO DATA AND A LOT OF PEOPLE WOULD SAY, WELL WE ACTUALLY SHOULDN'T BE DOING THAT WITH REGARD TO DATA BECAUSE WE'RE GETTING BACK TO THE BALANCING OF ALL WE COULD LEARN FROM DOG THIS--DOING THIS KIND OF RESEARCH AND THERE'S NOT A LOT OF EVIDENCE THAT PEOPLE HAVE BOTHERED OR HARMED OR WHATEVER CATEGORY YOU WANT TO USE, SO THAT IS ONE ASPECT, I THINK IT SHOULD AT LEAST BE POINTED OUT. YOU ARE MAKING A VALID POINT BUT IT'S WRAPPED UP IN THIS MUCH MORE COMPLICATED LINE DRAWING ISSUE THAT PEOPLE SAID A LOT ABOUT YESTERDAY AND IT'S STILL HERE WHETHER YOU LIKE IT OR NOT. >> ANOTHER POINT AND VALERIE WAS NOTING THAT THE C-POINT ON THE FIRST ONE WE'RE TALKING ABOUT HERE WOULD INVOLVE LESS INVESTIGATOR DETERMINE NATION BECAUSE APPARENTLY, I'M SORELY NOT AN EXPERT WITH THESE PROVISIONS IF YOU'RE A FEDERAL EMPLOYEE WHOSE SUBJECT TO THESE RULES, YOU WOULD KNOW IT, SO THAT WOULD BE THESE PROTECTIONS WOULD BE IN PLACE, AGAIN THAT WILL NOT ADDRESS THE SECOND ISSUE OF YOUR SAYING WHAT YOU WANT, OR SOMETHING BEYOND THE ACTUAL PRIVACY, BUT WE JUST WANT YOU TO KNOW, SORT OF A LITTLE DIFFERENCE IN TERMS OF THE [INDISCERNIBLE]. >> SO, COULD I JUST ASK A GENERAL QUESTION FOR ALL THESE, THE B-TWO CATEGORY THINGS IN THE SORT OF INTRODUCTORY PART IT SAYS WHEN ALREADY SUBJECT TO INDEPENDENT CONTROLS WITHOUT THE APPLICATION OF THESE REGULATORY REQUIREMENTS, SO WHEN I LOOK AT RESEARCH INVOLVING THE USE OF EDUCATIONAL SURVEY PROCEDURES, ET CETERA, I WASN'T SURE, LIKE WHAT ARE THE INDEPENDENT CONTROLS, NOT PART OF THIS--THIS RULE--THAT PEOPLE WERE THINKING ABOUT. I WASN'T SURE IF THIS WAS MEANT TO EXCLUDE A LOT OF THINGS THAT ARE NOW THAT NOW WE TREAT AS THAT IS NOT THE CATEGORY-- >> I WASN'T SURE IF IT WAS MEANT TO COVER MOST OF THE THINGS WE NOW TREAT AS EXEMPTIONS OR NOT, BECAUSE I JUST WASN'T SURE. THERE WERE A LOT OF SURVEYS AND EDUCATIONAL TESTS AND INTERVIEWS THAT I DON'T KNOW WHAT OTHER YOU KNOW--WHAT OTHER INDEPENDENT CONTROLS THEY WOULD BE SUBJECTED TOO. >> THEY'RE LISTED AND IF YOU GO TO THE NEXT ONE, THE B-TWO, ACTUALLY THAT ONE DOESN'T HAVE ANY OTHER SOURCES! B-TWO, THREE AND FOUR BOTH REFER TO OTHER LAWS. SO IT'S ACTUALLY ONLY THE SECOND ONE THAT DOESN'T HAVE ANY. >> BUT SO THE THING IS, ARE THOSE OTHER LAWS, THE ONLY INDEPENDENT CONTROLS THAT WE'RE TALKING ABOUT, BECAUSE THEN YOU'RE BASICALLY ONLY REFERRING TO SURVEYS AND EDUCATIONAL TESTS WHEN THEY'RE IMPLEMENT BOOED I GOVERNMENT EMPLOYEES OR SOMETHING. >> UNDER THOSE LAWS ABOUT YOU THEN HIPAA TOO. >> AND HIPAA, YEAH, OKAY. >> SO THE EXAMPLE THAT WAS USED AT COMMITTEE MEETINGS FOR WHAT IT'S WORTH WAS IMAGINE THERE'S A SCENARIO WHERE THERE'S A DISASTER LIKE NINE-11 AND RESEARCHERS GO IN AND START QUESTIONING PEOPLE ABOUT THEIR FEELINGS OF THEIR FAMILIES. AND IS THAT REALLY APPROPRIATE AND DO YOU WANT TO LEAVE THAT-- >> BUT WOULD IT BE BECAUSE THAT WOULD--IF IT'S UNIVERSITY RESEARCHERS THEY'RE NOT COVERED BY HIPAA, THEY WOULDN'T BE COVERED BY THE PAPERWORK REDUCTION ACT SO THIS IS MY QUESTION IS IT WASN'T CLEAR TO ME WHAT THAT LANGUAGE REALLY MEANT AND IF IT ONLY MEANS THOSE LAWS AND HIPAA THEN-- >> I THINK THERE'S A MIX BETWEEN TWO IDEAS, ONE IS THAT IF IT'S COLLECTED OR IT'S UNDER ANOTHER PRIVACY PROTECTION, THEN IT'S EXCLUDED SO IT WASN'T JUST THE PRIVACY PROTECTIONS IT WAS A MIX OF REASONS WHY THIS DOES NOT NEED ANY-- >> YEAH BUT THAT PREAMBLE SHOULD COVER ALL OF THE--AND SO FORTH HERE AND SO EVEN IF IT'S COLLECTED INDEPENDENT CONTROLS IT SHOULDN'T FALL WITHIN THIS EXCLUSION. >> I THINK YOU'RE READING AND/OR, YOU ONLY HAVE TO MEET ONE OF THOSE RIGHT. >> RIGHT. >> BUT THERE'S THIS PREAMBLE THAT SHOULD APPLY TO ALL OF THEM. >> THIS GETS INTO INDEPENDENT CONTROLS AND I SUSPECT THAT THE FACT THAT IN THAT ONE PARTICULAR EXCLUSION IT INVOLVES INFORMATION, YOU ONLY GET BECAUSE THE PERSON GIVES IT TO YOU. THE FACT THAT YOU HAVE TO ASK THE PERSON THE INFORMATION MIGHT BE A SEPARATE TYPE OF INDEPENDENCE THAT IS A PART FROM THE PRIVACY AND CONFIDENTIALITY PROTECTION. BUT I MEAN WE COULD CERTAINLY-- >> AH, OKAY. SO INDEPENDENT CONTROL MIGHT NOT MEAN INDEPENDENT LEGAL CONTROL. IT MIGHT MEAN SOMETHING ELSE, OKAY. >> IN ANY EVENT THE CATEGORIES ARE DESCRIPTORS, WHAT MATTERS DO YOU THINK THIS SHOULD BE EXCLUDED OR DON'T YOU THINK THEY SHOULD BE EXCLUDED. >> RIGHT BUT I'M TRYING TO FIGURE OUT WHAT IT'S PROPOSING TO EXCLUDE, RIGHT? IN ORDER TO UNDERSTAND WHETHER I THINK IT SHOULD BE EXCLUDED OR NOT, I HAVE TO UNDERSTAND WHAT-- >> I DON'T THINK THERE'S--IS THERE A LACK OF CLARITY IN TERMS OF WHAT ACTUALLY THIS WOULD A--BITS PLIE TO BECAUSE I'M HAPPY TO TRY TO CLARIFY THAT TO THE EXTENT THERE'S ACTUALLY A DISPUTE ABOUT FOR EXAMPLE IN THE SURVEY ONE WHAT IT APPLIES TO. SO IT'S BASICALLY SAYING, I THINK THE FIRST TWO PRONGS AND IT APPLIES TO CURRENT EXEMPTION, TOO. >> OKAY. >> THAT WASN'T CLEAR TO ME, BECAUSE I WAS TRYING ON FIGURE OUT WHAT THE INDEPENDENT CONTROL WOULD BE IF A UNIVERSITY RESEARCHER WAS DOING A SURVEY. >> I DON'T THINK IT'S INDICATING THERE IS ANY OTHER CONTROL AT LEAST THOSE FIRST TWO PRONGS OF THAT EXCLUSION. >> WELL I CAN FIX THIS LANGUAGE UP OVER LUNCH. >> AND I THINK IN BRIEF RESPONSE TO JERRY, SEE SOME CONSISTENCY BETWEEN WHAT WE DID YESTERDAY AND WHAT WE DO HERE WHICH IS TO BRING A NUMBER OF THESE ISSUES UNDER SOME LEVEL OF IRB OVERSITE AND I TAKE THE POINT THAT PART OF IT MAY BE RISK BASED BECAUSE PEOPLE MAY MISCONSTRUE THE NATURE OF THE RISK OF THEIR PROJECT AND INDEPENDENT EYE ON, AND SOME OF THOSE WOULD BE WISE AS WELL AS WAYS TO ENGAGE PEOPLE WHEN THEY NEED TO BE ENGAGED AND APPROPRIATE WAYS FOR THE RESEARCH SO IT'S RESPECT FOR PERSONS AS WELL AS A RISK BASED CONCERN ABOUT THE--SOME TRIALS THAT WILL BENEFIT FROM SOME OVERSIGHT. >> SO WE HAVE A BREAK SCHEDULED IN THREE OR FOUR MINUTES DO YOU WANT TO TRY TO DO ONE MORE, WE CAN TRY TO FINISH OFF THIS CATEGORY BECAUSE I THINK THEY'RE ALL PRETTY SIMILAR. >> WELL, I HOPE SO. >> I WILL NEED EXPLANATIONOT NEXT ONE, TOO,. >> MAYBE WE SHOULD TAKE A BREAK. >> OKAY, LET'S DO THAT. WHY DON'T WE--HOW MUCH TIME DO WE HAVE SCHEDULED FOR OUR BREAK HERE. 15 MINUTES. SO 10:45. PROMPTLY. >> WELCOME BACK EVERYBODY, WE'RE NOW MOVING TO PROPOSED EXCLUSION 101 B-TWO ROMMENET TWO WHICH APPLIES TO RESEARCH AND INVOLVING COLLECTION OR TODAY OF INFORMATION THAT HAS BEEN OR WILL BE ACQUIRED SOLELY FOR NONRESEARCH ACTIVITIES OR THAT WERE ACQUIRED FOR RESEARCH STUDIES OTHER THAN THE PROPOSED RESEARCH STUDY WHEN EITHER OF THE FOLLOWING TWO CRITERIA ARE MET, A-SOURCES ARE PUBLICLY AVAILABLE OR B-THE INFORMATION IS RECORDED BY THE INVESTIGATION IN SUCH A MANNER, AND IDENTED TO THE SUBJECT, THE INVESTIGATOR DOES NOT CONTACT THE SUBJECTS AND THE INVESTIGATOR WILL NOT REIDENTIFY THE SUBJECT OR ANALYSIS THAT COULD LEAD TO CREATING IDENTIFIABLE PRIVATE INFORMATION. SO THIS IS BASICALLY THE CURRENT B-FOUR REVISED TO MAKE IT APPLICABLE TO RESEARCH COLLECTED PAST THE DATE OF THE DETERMINE NATION THAT IT'S EXEMPT AND ALSO PROVIDING EXTRA PROTECTS BY REQUIRING AN INVESTIGATION TO DO SOMETHING THAT MIGHT DE-IDENTIFY THE SUBJECTS. AND WHAT CAME OUT OF THE SUBCOMMITS AS THE OTHER SECTIONS IN THE B-SECTION ACCIDENT THIS DID NOT PROVIDE ENOUGH OVERSIGHT OF THE INVESTIGATORS, THAT THERE NEEDED TO BE ANOTHER PERSON INVOLVES IN DECISION MAKING. >> I GUESS I WOULD LOAMACYIC TO RESPECTFULLY DISAGREE. I MEAN I THINK THAT I'M STRUGGLING TO FIBBED THE VALUE ADDED PROPOSITION HERE EVEN FOR EXEMPTION FLAW, I THINK WE HAVE AN OPPORTUNITY HERE TO DECREASE BURDEN ON INVESTIGATORS, DECREASE BURDENS ON IRBs. YOU KNOW THE INFORMATION IS PUBLICLY AVAILABLE, WHAT ADDITION HARM WILL BE CAUSED BY AN INVESTIGATOR AND I THINK SIMILARLY WITH THE CONDITION B, DEIDENTIFY IS NOT RECORDED IDENTIFIED EXPLICITLY STATED, YOU CAN'T DEIDENTIFY OR CONDUCT ANALYSIS AND I'M JUST STRUGGLING WITH WHAT'S GAINED BY PUTTING THIS IN AN EXEMPTION CATEGORY BEYOND MAKING AN INVESTIGATOR FILL OUT A FARM AND MAKING SOMEBODY FOR ALGORITHMS LOOK AT THAT FORM AND I JUST--I REALLY THINK--I WOULD SUPPORT THIS STAYING AS AN EXCLUSION. OTHER THAN THE EXCLUSIONS AND EXEMPTIONS BEING THERE, I AGREE. >> AND I ALSO AGREE. >> AND I DISAGREE JUST BECAUSE THE PROCESS OF FIGURING OUT WHICH EXCLUSIONS ARE RESEARCH THAT'S EXCLUDED--IT JUST, THERE CAN BE SUCH A THING AS AN EASY EXEMPTION AND THIS MAY WELL FALL INTO THE CATEGORY OF AN EASY EXEMPTION BUT THE IDEA OF SAYING, WE REALLY ARE GOING TO PARSE OUT IN THIS WAY AND LEAVE INVESTIGATORS WITHOUT ANY MEANINGFUL GUIDANCE TO DETERMINE WHEN RESEARCH IS EXCLUDED AND WHEN IT'S EXEMPT WHEN WE ALL AGREE IT'S HUMAN SUBJECTS RESEARCH SEEMS UNNECESSARILY COMPLEX AND I WOULD KEEP IT INLET EXEMPTION--I WOULD KEEP THE RECOMMENDATION TO MOVE IT TO THE EXEMPTION CATEGORY BUT AGAIN, ACKNOWLEDGE IT COULD BE A VERY EASY EXEMPTION AND NOT REQUIRE VERY MUCH BUT AT LEAST PROVIDE THAT CONNECTION BETWEEN THE EXEMPTION TOOL IS THE INVESTIGATOR AND POTENTIALLY THE IRB ON THE OTHER END WHERE WE CAN WHERE WE CAN GAIN KNOWLEDGE ABOUT HOW ALL THIS STUFF WORKS AND INVESTIGATORS, DON'T HAVE TO JUST MAKE THOSE DETERMINE NATIONS ON THEIR OWN. >> AND I WOULD SAY, B-FOUR TALKS ABOUT EXISTING DATA AND SPECIMENS, WHERE AS THIS TALKS ABOUT AND DATA THAT WILL BE GENERATED OR INFORMATION WE GENERATED IN THE FUTURE. SO I'VE ALREADY PLANNED TO STUDY AND I PLAN TO GET THIS INFORMATION THAT DOESN'T YET EXIST AND I THINK IN THAT CASE, IF SOMEBODY CAN GET CONSENT FOR THAT KIND OF RESEARCH, THEY SHOULD AND HERE'S THE KIND OF THEN I'M THINKING ABOUT, I WORK WITH INVESTIGATORS WHO HAVE WRITTEN ALGORITHMS THAT CAN SUCK OUT OF MEDICAL RECORDS INFORMATION ABOUT STRUCTURE RELATED GEANIOLOGY AND THEN ASSOCIATE WITH THAT INFORMATIONS ABOUT PATTERN OF DISEASE TRANSMISSION, RIGHT? IT DOESN'T HAVE TO BE INDIVIDUALLY IDENTIFIABLE, WHAT IF THAT WERE TO HAVE TO HAPPEN TO THE HAVASUPI, AND I THINK THERE'S AREAS HERE WHERE YOU COULD MAKE CLAIMS ABOUT GROUPS OF PEOPLE, PEOPLE IN LITTLE TOWN A IN WISCONSIN, ABOUT AMISH PEOPLE IN WISCONSIN, VERSUS THERE ARE PEOPLE IN WISCONSIN AND IF YOU TALK ABOUT INFORMATION PERSPECTIVELY THEN THAT KIND OF STUFF SHOULD BE REVIEWED AND PERHAPS WE SHOULD REQUIRE CONSENT OR THINK ABOUT REQUIRING CONCEPT BECAUSE NOT ALL OF IT IS GOING TO BE--NOT ALL OF IT IS GOING TO BE LOW RISK OR UNOBJECTIONABLE. >> OKAY, I'VE GOT JONATHAN, JIM AND TOM. >> IN RESPONSE TO NANCY, I MEAN, I THINK WHAT I'M HEARING IS THAT YOUR OBJECTION IS NOT SO MUCH TO WHAT WILL HAPPEN IN TERMS OF THIS AND IT'S REALLY TO TRY TO MAKE A DISTINCTION BETWEEN WHAT'S RESEARCH AND WHAT'S NOT RESEARCH AND SO THAT'S REALLY MORE FUNCTION OF THE PREAMBLE AND THE ARTIFICIAL DIVISIONS THAN THE VALUE OF THE REVIEW ACTIVITY EXCEPT ACKNOWLEDGING THAT YES THIS IS RESEARCH AND THE QUESTION IS I THINK--IS THIS RESEARCH THAT REQUIRES ANY LEVEL OF OVERSIGHT AT ALL. AND THEN, PILLAR, I MEAN, YOU MAY CORRECT BUT MOVING IT TO AN EXEMPTION DOESN'T ADDRESS THAT, MOVING TO AN EXEMPTION ALLOWS TOOLS AND THEY DON'T HAVE TO GET CONSENT. MORPH OFTEN THE STUDY THAT WE'RE TALKING ABOUT HERE IS SORT OF A MORE TRADITIONAL MEDICAL RECORD REVIEW AND YOU KNOW IT'S JUST, THEY'RE GOING TO BE JUST EXTRACTING DATA AND SO WE'VE NOW GIVEN AN ARBITRARY TIME POINT WHERE YOU CAN'T DO ANYTHING THAT ACCUMULATED AFTER THE DATE YOU SUBCOMMITTED YOUR IRB APPLICATION WHICH IS SOME ARTIFICIAL, DOESN'T HAVE REAL MEANING AS TO IN TERMS OF SUBJECT PROTECTIONS AND JUST MEANS THAT THE INVESTIGATOR IN A YEAR OR TWO IS GOING TO PUT IN ANOTHER APPLICATION AND EXTEND THEIR DATE WITH WHEN WE KNOW THEY COULD JUST COLLECT IT GOING FORWARD FOR A PERIOD OF TIME. SO, AGAIN, I JUST FEEL LIKE THAT WE HAVE AN OPPORTUNITY HERE TO REALLY MINIMIZE BURDEN ON INVESTIGATES AND IRBs THAT IT'S NOT A VALUE ADDED PROPOSITION MOST OF THE TIME, VAST MAJORITY OF THE TIME. SO I'M READING THIS IN A SLIGHTLY DIFFERENT WAN THAT PILLAR IS AND THAT IS IN HER EXAMPLE SHE WOULD WILL HAVE TO GET IRB APPROVAL FOR THE ORIGINAL DATA COLLECTION, BUT THIS SEEMS TO BE SPEAKING TO IS EVEN PROSPECTIVELY IF I HAVE A STUDY I'M GOING TO DO IN THE FUTURE, THAT STUDY IS LIKELY TO REQUIRE SOME SORT OF IRB APPROVAL. IN THE COURSE OF CONDUCTING THAT STUDY, VARIOUS DATA WILL BE ACCUMULATED. SO IF I WANT DO SECONDARY DATA ANALYSIS PROVIDED THAT THE DATA IS PUB LIKELY AVAILABLE OR IT'S BEEN PROCESSED IN SUCH A WAY THAT THE SUBJECTS ARE NO LONGER IDENTIFIABLE, THEN, IT CAN FALL INTO THE EXCLUSION CATEGORY AND I CERTAINLY SUPPORT THAT. >> WELL EXCEPT THAT THIS IS ONLY FOR DATA COLLECTED INITIALLY, OKAYS, AND SO FOR RESEARCH STUDIES LITTLER THAN THE PROPOSED STUDIES, YES, RIGHT, BUT I STILL THINK THAT MY CONCERN APPLIES THAT SOMETIMES THAT'S GOING TO BE JUST FINE AND THE SECONDARY ANALYSIS WILL BE COMPLETELY UNOBJECTIONABLE, AND SOMETIMES, I THINK PROBLEMATIC AND AT LEAST IF IT'S AN EXEMPTION THERE'S A RECORD THAT THIS RESEARCH IS GOING ON AND SOMEBODY HAD TO GO THROUGH SOME KIND OF TOOL OR SOME SECOND PERSON HAD TO LOOK AT IT SO AGAIN I THINK THE PURPOSE OF THAT IS JUST TO STOP AND THINK ABOUT WHETHER THERE'S A PROBLEM AND IT DOESN'T HAVE TO BE HUGELY BURDENSOME, BUT IT'S TOO EASY TO GET SO WRAPPED UP IN YOUR OWN DAY-TO-DAY WORK AND IN THE IMPORTANCE OF WHAT YOU'RE DOING AND HAVING SOMETHING THAT JUST CAUSES PEOPLE JUST TO STOP AND THINK, IS VALUABLE. >> SO FIRST OF ALL I SUPPORT THIS EXCLUSION AND CATEGORY, I THINK THE BROADER CONTEXT IN WHICH SOCIOLOGICAL LOGICAL FEATURES THAT MIGHT BE AFFECTED BY THIS AND THE CONTEXT IN WHICH THEY'RE WORKING NEEDS TO BE OOPED MORE FULLY HERE, IN SOME INSTITUTIONS I DON'T KNOW HOW MANY, BUT I'VE HEARD FROM QUITE A FEW INVESTIGATORS THE EXEMPTION CATEGORIES ARE DISAAND NONACTIVITY FOR THEM AND STILL HAVE TO URPD GO THE IRB REVIEW AND OTHER INSTITUTIONS, USED TO BE MY OWN BUT THANKFULLY NO MORE, EXEMPT WITH NOTHING MORE WITH THE CATEGORY OF REVIEW BY THE IRB. AND I THINK FOR ME THE OUTCOME OF EXTREMELY LOW RISK REWARD WITH PUBLICLY AVAILABLE DATA TO THE EXCLUSION CATEGORY IS JUST AS JOHNSON SAID WE AFFORD THE EQUIVALENT PROTECTIONS THAT THESE INDIVIDUALS ARE BEING AFFORDED NOW TO THE EXCLUSIONS OF THE IRB. >> JUST IN TERMS OF A WAY OF LOOKING AT THE EXEMPTION, IN MANY WAYS IT'S SIMILAR TO ACTUALLY USING DEIDENTIFIED DATA, IN FACT IT'S WHAT I WAS RAISING EARLIER, THE ONLY DIFFERENCE BETWEEN ONE WAY OF DOING THESE STUDIES WOULD JUST BE TO HAVE SOMEBODY FROM THE MEDICAL RECORDS ROOM COLLECTED AND DISTRIBUTED AND GIVE IT TO THE RESEARCHER AND IF THAT'S DONE, YOU'RE NOT USING A HUMAN SUBJECT AND THEREFORE NO REVIEWS REQUIRED AT ALL, BUT THIS CURRENT EXEMPTION SAYS WELL, SOMETIMES IT'S ADMINISTRATIVE CONVENIENCE TO PAY SOMEBODY TO DO THAT SO LET'S LET THE RESEARCHER DO THAT BUT ONCE THEY WALK OUT OF A MEDICAL RECORD ROOM, THEY BASICALLY HAVE DEIDENTIFIED DAT AND THEREFORE WE TREAT IT AS DEIDENTIFIED DATA SO GETTING BACK TO THE PREMISE, YES, CERTAINLY CAN YOU DO RESEARCH, WITH DATA THAT SOME OF THESE MINORITIES MAY NOT LIKE WHAT THE RESULTS ARE BUT THIS IS PROBABLY ONE OF THOSE AREAS WHERE I SOFTER OF AGREE WITH MARK IN TERMS OF OUR SYSTEM GENTLEMENLY ALLOWS THAT SORT OF THING TO HAPPEN. LOTS RESEARCH OCCURS THAT WE MAY OR MAY NOT LIKE YOU GO IN GENERAL WE SORT OF ENCOURAGE THAT SORT OF THING. THAT'S ONE WAY OF LOOKING AT WHAT EXEMPTIONS ARE DOING. >> SO THIS IS JUST ONE WHERE I CAN'T ANTICIPATE PROBLEMATIC RESEARCH AND ONE WHERE RESEARCH MIGHT BE A SERIOUS CONSIDERATION, THIS CATEGORY SEEMS TO ME LESS OBVIOUSLY RAISING RISK ISSUES OR CONSENT ISSUES SO, WHAT WAS THE-- >> THE SUBCOMMITTEE LEVEL, THIS WAS THE LAST OF THE FOUR WE CONSIDER, RIGHT AS I REMEMBER IT. >> AND HERE THE DISCUSSION CAME DOWN TO DO WE NEED A THIRD PARTY OPINION OR A TOOL OPINION ABOUT WHETHER IN FACT, YOU ACTUALLY ARE COLLECTING THOSE OR IN SUCH A WAY THAT'S NOT IDENTIFIABLE, AND THEN HAVE YOU A DATA COLLECTION TOOL TO SAY, HEY, WAIT A MINUTE TO SAY YOU HAVE THE MEDICAL TOOL WHATEVER. >> IF WE SHIP THE MEDICAL RECORDS TO SOMETHING LIKE DB GAP OR DATABASES AND GENO TYPES AND PHENOTYPE WHICH I ASSUME IS A PUBLICLY AVAILABLE TOOL. >> IT'S NOT PUBLICLY AVAILABLE, IT'S CONTROLLED. I THINK WE DON'T. >> SO WE HAVE A WIDELY SPLIT GROUP, I DON'T THINK WE NEED TO TAKE A VOTE TO ILLUSTRATE THAT. >> [INDISCERNIBLE]. >> THE NEXT QUESTION WILL BE, WHAT DO WE WANT TO DO WITH THIS. DO WE WANT THEM TO MOVE THIS WHOLE EXCLUSION INTO THE EXCLUSIONS WE SUPPORT OR ARE FOLKS--IS THERE ENOUGH DIVISION OF OPINION TO SAY, LET'S JUST NOT COMMENT ON THIS ONE EITHER WAY. >> WHEN WHAT--WAKIND ABOUT THE PROPOSAL AND IT DOESN'T NECESSARILY REFLECT MY THOUGHTS BUT TO MOVE FORWARD, MY SENSE IS THAT EVERYBODY AGREES THAT IT'S PUB LIKELY AVAILABLE THERE'S NO REASON TO DO ANYTHING MORE. SO WHAT IF WE ENDORSE LEAVING THAT HERE AND LEAVING THE OTHER PIECE. >> THAT WOULD MOVE THE MEDICAL RECORD DOMAIN WHICH IS SUCH A LARGE DOMAIN INTO AN EXEMPT CATEGORY RATHER THAN EXCLUDED WITH THE EMPLICATION THERE. I'M NOT SURE HOW SPLIT WE ARE, MAYBE HALF OF US. >> I SUGGEST A VOTE. >> JEFF CAN I--POSE A QUESTION FIRST. >> AND THEN GETTING BA BEING TO THE MEDICAL RECORD SITUATION, IF YOU WALK INTO THE MEDICAL RECORD ROOM AND SAY, I WANT TO THE INFORMATION ON ALL THE PARTICULAR DEMOGRAPHIC GROUP THAT YOU'RE INTERESTED IN, AND YOU WALK OUT AND IT'S DEIDENTIFIED. SO IF WE COULD ELIMINATE THE INVESTIGATOR BEING ABLE TO WALK IN AND SAY, I WANT INFORMATION ONLY ABOUT THIS GROUP, THAT TO ME WOULD SATISFY THE CONCERN. >> [INDISCERNIBLE] >> I'M TRYING TO REMEMBER OUR DISCUSSION ABOUT THIS. FOR MANY EN--STRATEGIES TUITIONS IT ISN'T A MEDICAL RECORDS ROOM, SO FOR EXAMPLE, WE HAVE EPIC AND THAT AN INVESTIGATOR HAS ACTESS TO EPIC, AND THAT ACCESS IS UNLIMITED, SO, THERE ISN'T THAT I HAVE ACCESS TO EPIC AND I CAN SEE MY PATIENTS. IT'S I HAVE ACSESSION SEASES TO EPI-BLASTIC AND I CAN SAY ANYTHING AND ANY PATIENT--I HAVE ACCESS TO INFORMATION AND I CAN SAY ANYTHING TO ANY PATIENT. BUT IF WE HAD A MEDICAL RECORDS IN AND YOU'RE NOT GOING INTO A ROOM AND THERE'S NO GATE KEEPING AND YOU COULD SAY AND YOU COULD CHECK WHO'S ADMITTED TO BRIGHAM HOSPITAL AND WHO WAS JUDGE ARED IN THE BOSTON MARATHON BOMBINGS AND YOU COULD WRITE DOWN INFORMATION AND YOU COULD SAY WELL THAT DOESN'T FIT THE EXCLUSION BECAUSE LIKELY THE INFORMATION THEY WRITE DOWN WILL BE IDENTIFIABLE, BUT I THINK THAT THIS IS WHERE THE SUBCOMMITTEE WAS VERY DINNERED THAT THIS EXCLUSION OPENED UP THE GATE TO HAVE ACCESS TO PRIVATE IDENTIFIABLE INFORMATION IN A WAY THAT WAS UNCONTROLLED. SO I'M JUST TRYING TO--I'M JUST TRYING TO REMEMBER WHY BECAUSE DAVID'S CORRECT. THE WE WERE VERY MUCH OPPOSED NOT TO THE PUBLIC AVAILABLE PART BUT TO THE OTHER PART OF IT AND IT WAS THAT NOBODY WOULD BE WORKING WITH THE INVESTIGATORS TO HELP THEM DETERMINE IF THEY WERE MAKING A CORRECT DENERMAL NATION TAP THEY'RE NOT GOING TO WRITE DOWN IDENTIFIERS. >> WELL, BUT HERE TOO, I DISAGREE THAT FIRST OF ALL, YOU ARE IDENTIFYING THE SUBJECTS BY YOUR EQUIP AND EFFORT ABOUT TRYING TO REQUEST SPECIFIC INFORMATION AND INDIVIDUALS BUT SECONDLY ALL OF US WHO USE EPIC ARE SUBJECT TO AUDITING OF WHO WE'RE LOOKING AT SO I DON'T HAVE TROUBLE GETTING INTO MY OWN PATIENTS BUT IF I GO TO LOOK AT THE C. E. O.'S RECORD IT'S DAMN CLEAR THAT SOMEONE'S GOING TO COME AFTER ME. >> SO I THINK THAT THE I THINK SOMEBODY'S INFORMATION AS HOW I RECORD IT THAT BECOMES THE CRITICAL ISSUE. AND YOU'RE RIGHT THAT THERE IS THE AUDITING TRAIL, THE QUESTION IS YOU WANT TO RELY ON AN AUDITING TRAIL. >> I THINK PART OF THE POINT IS THE INTERNALCONTROLS THAT PEOPLE AREN'T JUST TROLLING THROUGH THE RECORDS. , SO THERE SEEMS TO BE SOME OF THE ISSUE WE HAD YESTERDAY, WHEN I READ DEIDENTIFIED NONIDENTIFIED AND UNIDENTIFIABLE AND WE USE CASUALLY ABOUT IDENTIFIERS AND THERE'S ANOTHER ISSUE THAT I HADN'T THOUGHT ABOUT WITH GROUP IDENTIFIERS OR IMPLICIT IDENTIFIERS AND I DONE KNOW IF WE WILL COME TO A CONCLUSION ON THAT AND I SUGGEST WE WILL MOVE THAT AND MAKE IT A NEW CRITERIA IN THE EXEMPTION TOOL. I MEAN THE EXEMPTION TOOL, SO THE OTHER THING ABOUT THE WHOLE IDEA OF EXEMPT AND EXEMPTION TOOL IS IT'S SUPPOSED TO BE EASY. I DON'T KNOW WHAT TO DO ABOUT INSTITUTIONS THAT DON'T ALLOW THE USE OF EXEMPTIONS BUT MAYBE THAT'S BEYOND THEIR SCOPE, BUT THE IDEA OF THE EXEMPTION TOOL IS, IT'S SUPPOSED TO BE REALLY EASY, WE'RE NOT TRYING TO MAKE IT HARDER, WE JUST TRYING TO PUT A CHECK IN PLACE. >> --SOME DATA SCIENTISTS STAND UP AND SAY, IT'S COMPLETELY RIDICULOUS TO IDENTIFY INFORMATION OR DEIDENTIFIED INFORMATION BECAUSE ANY DATA ELEMENT CAN BE IDENTIFYING OR COMBINATION OF DATA ELEMENTS CAN BE IDENTIFYING IN THE RIGHT CONTEXT, RIGHT AND SO EYE HAD BEEN FEELING LIKE THERE ARE DATA FIELDS AND KINDS OF DATA THAT ARE READILY IDENTIFIABLE BECAUSE THEY HAVE EXPLICIT IDENTIFIERS ATTACHED AND THEN THERE'S EVERYTHING ELSE THAT MAY OR MAY NOT BE IDENTIFIABLE DEPENDING ON THE CONTEXT AND THE POINT ABOUT THE GROUP IDENTIFIERS AND ATTRIBUTES, THAT DOES GIVE ME HEART BURN, BUT THE PROBLEM IS, IF YOU JUST STRIP OFF LIKE RACIAL AND ETHNIC IDENTIFICATION OR THINGS LIKE PEOPLE'S ZIP CODE AND THERE ARE STILL LOTS OF PROXIES IN THE MEDICAL RECORD THAT A DATA SCIENTIST COULD EASILY USE TO FIGURE OUT WITH A VERY HIGH DEGREE OF PROBABILITY WHO IS OR IS NOT A MEMBER OF A CERTAIN GROUP OR LIVED IN A CERTAIN COMMUNITY, RIGHT, SO THAT'S PART OF WHY I THINK THE KIND OF SO CALLED DEIDENTIFIED IT'S REALLY NOT AND I WISH WE WOULDN'T EVEN USE THAT TERM BUT I KNOW IT'S STILL, THERE WEREN'T PROPOSED CHANGES TO THE USE OF THAT TERM AND USED THROUGHOUT HERE SO, I CAN'T REALLY--I MEAN IT'S HARD TO KNOW WHAT TO DO ABOUT THAT, BUT IT DOES MAKE ME CONCERNS ABOUT PART B HERE. >> WHEN MARK INDICATE THAD WHEN WE USE THAT TERM WE REFER TO THE COMMON RULE ABOUT IDENTIFIABLE, MAYBE WE NEED TO BUMP THAT FOOT NOTE UP TO A DOCUMENT LEVEL CLEARANCE SO THAT WHAT WE'RE REFIELD FUNCTIONING TO IN THAT REGARD. >> NOT ONLY THAT. >> HOLLY? >> I HEAR WHAT YOU'RE SAYING PILLAR, BUT THE RESPONSE IS NOT TO WORRY ABOUT WHETHER THINGS ARE IDENTIFIABLE BUT PUBLISH IDEBTIFICATION WHICH WE PROPOSE TO DO WITH THE SECTIONAL ANALYSISARY ELEMENT AND MAKE THAT RECOMMENDATION MORE SWEEPING. >> WHAT DO YOU THINK OF THE PROPOSITION OF LEAVING A AS AN EXCLUSION PUBLICLY AVAILABLE SOURCES? >> YEAH, I LIKE THAT, I'M STILL NOT WHOLLY WILLING TO GIVE UP B, I THINK IT'S INTERESTING AND JUST THIS COMMENT THAT A LOT OF THIS DISCUSSION REVOLVES AROUND MEDICAL RECORDS AND A LOT OF THE RESEARCH THAT I'M THINKING OF HAD ABSOLUTELY NOTHING TO DO WITH MEDICAL RECORD, SO, PILOT PROJECT DON'T KNOW HOW TO DISENTANGLE THE TWO, I HEAR THE CONCERNS YOU'RE RAISING AND I RECOGNIZE THAT THEY'RE REAL CONCERNS AND I ADD TO THAT JUST A HUGE SWATH OF RESEARCH AND THAT COULD BE COVERED BY THIS AND HAS NOTHING TO DO WITH MEDICAL RECORDS. YOU WANT TO EXCLUDE MEDICAL RECORDS FROM THIS, THAT WOULD BE GOOD. >> --PUB LIKELY AVAILABLE DATA IS EXCLUDED IF IT IS INFORMATION IN B THEN IT'S GOING TO BE AN EXEMPTION CATEGORY, AND I THINK THAT WHAT I WROTE THERE ABOUT THE DIG NETY HARM WE DON'T HAVE TO ADDRESS. >> RIGHT. WELL IT SEEMS TO ME GIB OUR TIME FRAME HERE THAT IT WOULD BE REASONABLE TO CRAFT. IN THAT REGARD. SO THOUGHTS ABOUT THIS? >> JUPE THAN? >> I LEAVE IT AS IS, BUT NOT ONLY FOR RESEARCHERS ON OUR CAMPUS BUT THEY WERE INITIALLY SO DELIGHTED TO SEE THIS, GO HOME AND TELL THEM SORRY, IT'S LIKE--YOU KNOW AND I THINK, AGAIN I JUST THINK THAT THIS IS, I LIKE IT AS IS. -- >> WE WILL NOT BE ABLE TO CRAFT THE LANGUAGE HERE, WE DON'T HAVE TIME BUT MAKE A SUGGESTION THAT THE--THAT SOMETHING BE ADDED TO ADDRESS AND I DON'T KNOW IF THERE'S A WAY TO CLEANLY CHARACTERIZE THAT LARGE SUBGROUP OF--OF RESEARCH THAT WON'T CAPTURE THE BIOMEDICAL PIECE. BUT WE MIGHT FEEL DIFFERENTLY ABOUT THAT AND ADD THE RECOMMENDATION THAT AN EXCLUSION BE CREATED FOR THAT PARTICULAR RESEARCH THAT'S BEYOND MY KNOWLEDGE YAWPED THAT CRAFT. >> WELL I'VE BEEN INCREASING A MOUNT OF SOCIAL AND ECONOMIC BEHAVIORIAL RESEARCH, ECOLOGY RESEARCH, THATTEN INCLUDING COLLECTION OF SPECIMENS, INCLUDES GENOMICS AND INCLUDES OTHER YOU KNOW BIOMEDICAL INFORMATION TRYING TO LOOK FOR A BIOMARKERS OF ATTACHMENT AND ATTACHMENT DISORDERS AND THERE'S ALL KINDS OF SOCIAL AND BEHAVIORIAL RESEARCH THAT I THINK COULD RAISE MANY OF THE SAME CONCERNS, RIGHT INSPECT SO IT'S NOT CLEAR HOW TO MAKE THAT DIVISION ALTHOUGH, I, YOU KNOW FRANKLY I HEAR FROM A WHOLE LOT OF LAWYERS WHO ARE USING COMPLEATLY PUBLIC INFORMATION OUT OF TRIAL TRANSCRIPTS AND THINGS LIKE THAT WHO ARE GETTING GRIEVE FROM IRBs AND I MEAN TRIAL TRANSCRIPTS, YOU HAVE INDIVIDUALS NAMES ASSOCIATED WITH THAT, RIGHT? BUT IT'S PUBLIC AND STILL THE IRB IS TRYING TO TELL THEM THAT THEY CAN'T DO THEIR RESEARCH, RIGHT SO I SYMPATHIZE A LOT WITH THE IDEA THAT SOMETIMES IRBs GET IT WRONG OR THEY DON'T EXEMPT THINGS THAT SHOULD BE EXEMPTED OR WHATEVER ELSE. I DON'T KNOW THAT I THINK THE EXCLUSION OF THINGS IN PART B IS THE WAY TO DEAL WITH THAT. >> I THINK WOOY MAYBE NEED TO PUT THIS TO BED, WHAT WE NEED TO DO IS SIMPLY DESCRIBE WHAT I THINK IS THE SENSE OF THE SACHRP AT THIS POINT WHICH IS THERE IS CONSENSUS AROUND A AS AN EXCLUDED CATEGORY, THERE'S NO CONSENSUS ABOUT B-AS AN EXCLUDED CATEGORY, BUT THERE WAS MIXED OPINIONS ABOUT WHETHER THIS EXCLUSION PROVIDES ADEQUATE OVERSIGHT FOR RESEARCH THAT WOULD FALL UNDER B AND THEN LEAVE IT AT THAT. DEPENDING ON WHAT ALL THE OTHER COMMENTS THAT COME IN, THIS MAY CONTRIBUTE TO--A SENSE OF THE LARGER COMMUNITIES ON THESE ISSUES. >> SO DO YOU WANT TO MOVE B OR NOT. >> I WOULD RECOMMEND RECOMMEND WE JUST DESCRIBE THE LACK OF AGREEMENT OPEN MEETING WHETHER THESE SHOULD BE EXCLUDED OR NOT. IS THAT ADEQUATE OR DO FOLKS WANT TO BE MORE DEFINITIVE. >> THE NEXT ONE IS 101 B-TWO, THREE, AND THIS SPLIES TO RESEARCH CONDUCTED BY FEDERAL GOVERNMENTS OR GENERATED GOVERNMENT COLLECTED INFORMATION FOR NONRESEARCH PURPOSES WITH CRIMINAL HISTORY DATA IF THE INFORMATION ORIGINALLY INVOLVED A COLLECTION OF SUBJECT PAPERWORK REDUCTION AT, 1995, THE INFORMATION MAINTAINED ON INFORMATION TECHNOLOGY THAT IS SUBJECT TO AND IN COMPLIANCE WITH SECTION 208 B OF THE GOVERNMENT ACT OF 2002, AND ALL OF THE INFORMATION COLLECTED AS PART OF THE RESEARCH AND MAIN TAN A SYSTEM OR SYSTEMS OF RECORDS SUBJECT TO THE PRIVACY ACT. AND SUBCOMMITTEE SAID THERE'S JUST NOT ENOUGH CONTROL. >> SO I LITTLE MORE NATURE-- >> I DON'T REMEMBER THE BACK GROUPED ON THIS. >> I WOULD DESCRIBE THE CONVERSATION AT THE SUBCOMMITTEE LEVEL AS GOING FOR THE CONCERNS ONE AND FOUR ESPECIALLY FOUR FOR HIPAA, AND EXPANDING ALL OF THESE WERE--I DON'T KNOW THERE'S A LOT OF THOUGHT, THEY WERE--THE END DECISION AFTER--MUCH MORE ABOUT MUCH MORE. AND THEN WE SAID IF HIPAA ISN'T GOOD ENOUGH THEN NEITHER IS THIS PRIVACY ACT. >> I DON'T UNDERSTAND WHY SO MAYBE WE SHOULD JUST GO TO FOUR BECAUSE THAT'S SORT OF MORE THE EXPERTISE AX ROUND THE TABLE BECAUSE I THINK IF WE FIND THE REASON--I DON'T THINK WE--THOSE OF US WHO HAVE CONCERNS HAVE CONCERN ABOUT THE SECURITY PROTECTIONS BEING ADEQUATE, IT'S MORE CONCERN ABOUT DIGNITYARY HARM, SO I DON'T KNOW WHY THAT WOULDN'T APPLY EQUALLY TO THIS. >> AND I THINK THAT WAS THE FEELING. >> YEAH. >> SO SCRATCH IT AND COME BACK. >> YEAH. >> SO FOUR APPLIES TO RESEARCH DEFINED BY THIS POLICY THAT INVOLVING DATA AND ANALYSIS, INVOLVING IDENTIFIABLE HEALTH INFORMATION OF RECIPIENT WHEN IT'S REGULATED UNDER PARTS 40 AND 64 PARTS A AND E FOR PURPOSES OF HEALTHCARE OPERATIONS IN RESEARCH AND DEFEIGNED 164501, OR FOR THE PURPOSE OF PUBLIC HEALTH ACTIVITY, AS DESCRIBED IN 512 B AND THE SACHRP, SUBCOMMITTEE BELIEVES THAT AND RECOMMENDED THAT PARTS 160 AND 164 DO NOT SUPPLY SUFFICIENT SAFE GUARDS IN RESEARCH AND RISK AND CONFIDENTIALITY AND THEREFORE SUBJECTS COULD SAY PSYCHOLOGICAL DIGS STRESS OR HAVE THE RESEARCH AND INFORMATION THEY WOULD NONAPOPTOTIC THE AGREE WITH AND UNDER AN EXEMPTION PROCESS WOULD NOT BE ALLOWED TO PROCEED FOR THESE TYPES. >> I MEAN WE'RE ONLY TALKING SUBSTANTIVELY, I RECOGNIZE IT'S DIFFERENT BUT THAT WAS OUR INTENT WITH THE EARLIER EXCLUSION. >> SO THIS WAS TALKING ABOUT HOW EFFICIENCY WOULD BE GAINED BY PUTTING IT IN AN EXCLUSION CATEGORY SINCE HAD TO BE REVIEWED BY A PRIVACY BOARD WHICH IS MANY CASES IS SERVED BY THE IRB,. >> EXTENSIVE DISCUSSION ON THAT ISSUE AND THE FEELING WAS THAT THE PRIVACY BOARD WAS NOT TASKED UNDER HIPAA AND THE PRIVACY BOARD WITH CONSIDERING ANYTHING OTHER THAN THE PRIVACY CONFIDENTIALITY COURT REPORTERS. NO CONCERNS FOR PSYCHOLOGICAL RISK, NO CONCERNS FOR OTHER PROTENTIAL ISSUES THAT MIGHT ARISE, RISK ISSUES, RISK BENEFIT. >> SO TWO FOLD CONCERN ABOUT AN EXCLUSION. ONE IS THE POTENTIAL LACK OF STREAMLINING THE PROCESS, BASICALLY IRB ANYHOW, AND CONFUSION OF RULES WITH PURELY PRIVACY BOARD, ATTENTION TO PRIVACY ISSUES AS OPPOSE TO SOME OF THE OTHER ISSUES THAT MIGHT BE RAISED IN THIS TYPE OF RESEARCH. >> WOULD BE HELPFUL TO CLARIFY IF THIS IS THE CASE THAT THE WAY YOU WOULD WILL LIKE SOME OF THESE INFORMATIONAL RISKS THAT MIGHT NOT BE ADDRESSED IN YOUR REVIEW BY HIPAA ROUGH ATOM TEAKS, HOW THEY WOULD BE ADDRESSED BY SEPERATE IRB REVIEW OF SOME KIND TO EXPLAIN, YOU KNOW THE PURPOSE OF HAVING ADDITIONAL PROTECTIONS. >> THE POINT IS THERE'S OTHER DIGNITYARYS ABOUT INFORMATIONAL RISK ABOUT WHAT KINDS MUCH RESEARCH PEOPLE WANT TO CONTRIBUTE AND PARTICIPATE IN. >> SO THAT CAN ALSO BE SOMETHING NA'S CLARIFIED AND AS YOU EXPLAINED WHAT MIGHT BE--WHAT WOULD OTHERWISE BE PROVIDED HERE. >> MAYBE TIE THIS AND GET TO IT LATER, THIS IS A BIGGER ISSUE IN TERMS OF BY AND LARGE AGAIN IDENTIFIABILITY AND DEIDENTIFIABILITY BECAUSE IT HAS NOTHING TO DO WITH THE FACT THAT THESE ITEMS ARE IDENTIFIABLE, AND IT'S CERTAINLY, THIS IS OPEN FOR DEBATE, GOING AGAINST, AND IT'S RUNNING THROUGHOUT THE NPRM AND IN GENERAL ALLOWING SECONDARY USE OF DATA IN A VARIETY OF CIRCUMSTANCES, WHEN YOU'VE ELIMINATED THE PRIVACY AND CONFIDENTIALITY RISK BECAUSE WE GET TO E-TWO AND IF I UNDERSTAND WHAT YOU WERE SAYING ABOUT E-TWO, YOU NOTICE PROVISION, AND ASSUMING NOTICE HAS BEEN GIVEN, YOU'RE SAYING IT'S OKAY SO MAYBE I'M MISREADING THAT AND SAIM ISSUES THERE, YOU WILL GIVE NOTICE, WE WILL SAY WE DO THIS STUFF, WE GIVE OUT IDENTIFIABLE INFORMATION, HAVE YOU THE SAME ISSUES AND LOTS OF PEOPLE CAN OBJECT TO ONE OR ANOTHER STUDY IF SOMEBODY DOES BY SECONDARY INFORMATION, THAT'S CERTAINLY THIS, AND YOU KNOW AND EVEN IF YOU GUESS--IF YOU LEFT THIS AS AN EXEMPTION, R, AND G WILL HAVE THE SAME ISSUES ABOUT WHETHER A CRITERIA FOR GRANTING THE EXEMPTION BECAUSE WERE THE YOU BASICALLY SUGGESTING THERE SHOULD BE NEW CRITERIA FOR THE CURRENT EXEMPTIONS TO PROTECT, I DON'T THINK OF ANYTHING IN SOME OF THESE CURRENT EXEMPTIONS, BUT NOW. >> A LOT OF INTUITIONS THAT SAY THAT HAVE POLICY WHEN IS YOU SAY LOOK AT AN EXEMPTION WE WILL LOOK AT ANYTHING THAT'S--EXACTLY SO I'M POINTING OUT IN MANY WAYS YOU'RE GOING BEYOND THE CURRENT RULES ARE DOING SO YOU'RE GOING IN THE OPPOSITE DIRECTION IN TERMS OF THE BROAD THEME OF WE BENEFIT A LOT OF SECONDARY USE OF DATA AND BIOSPECIMENS AND THE CHANGE YOU'RE TOGGING ABOUT HERE IS ALMOST LIKE--WELL ACTUALLY OUR CURRENT RULES ARE NOT PROTECTIVE ENOUGH, THEY SHOULD RESPECT ALL THESE GROUP ARMS, ET CETERA, ET CETERA WHICH IS AN INTERESTING DIRECTION BUT USUALLY HIGHLIGHTED IN THE COMMENTS. >> SO I THINK YOU'RE RIGHT. >> I SORT OF DITTO SOME OF THE COMMENTS I MADE ON THE LAST ONE, THAT THIS TRULY IS, YOU KNOW SO THIS IS THE IDENTIFIABLE RETROSPECTIVE REVIEW, MOSTLY WOULD BE THE STUDIES THAT COME UNDER THEM. THE DIFFERENCE WOULD BE THE WAIVER, 99.9% OF THE TIME AND SO NOW, YOU KNOW IT WOULD BE EXCLUDED OR AGAIN, ARE WE GOING TO GENERATE POLICY ON THE SMALL MINORITY OF STUDIES THAT HAVE THIS GROUP ARM, AND SHOULD WE NOT ALLOW THOSE ANYWAY, MAYBE THEY'RE GOOD RESEARCH, I'M NOT SURE, GENERATING POLICY AROUND A SMALL MINORITY PROBLEM IS A GOOD WAY TO GO. >> SO I THINK IF SOMETHING GETS A WAIVER OF THE INFORMED CONSENT THEN IT'S STILL GOT AN IRB REVIEW AND IT HAS TO DECIDE WHETHER THIS IS APPROPRIATE FOR A WAIVER OF CONSENT BUT WHETHER IT WAS DESIGNED IN A WAY THAT IT MINIMIZED RISK FOR INSTANCE OF A VARIETY OF SOURCE AND THAT'S DIFFERENT THAN SAYING NO ONE LOOKS AT IT. >> ALTHOUGH AGAIN IN THIS CASE, I MADE THE ARGUMENT PROBABLY IN THE DIRECTION A MINUTE AGO WHICH IS TO SAY THAT THE PRIVACY BOARD DOES LOOK AND WILL LOOK AT THIS CATEGORY OF RESEARCH, SO THERE IS SOME LEVEL OF OVERSIGHT. NOW ADMITTEDLY, THE SCOPE OF THEIR REVIEW IS DIFFERENT, BUT YOU KNOW WOULD WE SAY THAT IF THERE'S SOMETHING SHOCKING THAT COMES THROUGH THE PRIVACY BOARD MIGHT WELL SAY, WELL, MAYBE BEYOND OUR PURVIEW, BUT THIS IS PROBLEMATIC RESEARCH, ISN'T IT, MIGHT THAT BE A SUFFICIENT LEVEL OF OVERSITE FOR THE KEENED OF UNUSUAL PROBLEMATIC PROTOCOL THAT WE'RE THINKING ABOUT. >> YOU KNOW JERRY RAISED A GREAT POINT IN TERMS OF LOGICAL INCONSISTENCY, I THINK WE'RE SO USED TO THINKING OF DEIDENTIFIED STUFF AS NOT HUMAN SUBJECTS THAT IT SORT OF FALLS IN A DIFFERENT CATEGORY BUT IT FALLS IN THAT CATEGORY BECAUSE WE'VE TAKEN OFF THE IDENTIFIER SO PROVIDED WITH THE PROTECTIONS, THE EXCLUSION IS TRYING TO DO AS WELL. AND I GUESS, I DON'T KNOW WHAT THE ANSWER IS, I MEAN I THINK THERE A LOT OF TRYING TO FIND THE RIGHT LEVEL OF, YOU KNOW PRACTICAL SUPPORT OF VALUABLE RESEARCH VERSES COMPLETE SUPPORT OF EVERYBODY'S INDIVIDUAL DECISION ABOUT EVERYTHING THAT HAPPENS TO THEM OR THAT THEY DO, AND I THINK WE'RE TRYING TO FIND THE BALANCE TO THAT AND IT'S NOT GOING TO BE CLEAN. AND I'M NOT SURE WHERE IT LIES. >> WELL AT LEAST I DON'T HAVE A CLEAR SENSE OF WHERE THE GROUP IS ON THIS PARTICULAR RECOMMENDATION. SO, ANY OTHER THOUGHTS BEFORE WE TRY TO GET A SENSE OF THE GROUP, ANY OTHER CREATIVE COMPROMISES HERE TO THINK ABOUT ON THIS ONE? ALL RIGHT. >> NO. >> SO, WHY DON'T WE--GO AHEAD, I DON'T THINK THERE'S A WAY TO SPLIT THIS ONE UP THE WAY WE DID WITH THE LAST ONE, WHETHER WE SUPPORT THIS AS AN EXCLUSION OR WANT TO MOVE IT TO AN EXEMPT CATEGORY SO THE SUBCOMMITTEE HAS PROPOSED MOVING IT TO AN EXEMPTION CATEGORY. >> SO I WILL TAKE A STRAW AND VOTE TO MOVE IT. >> I WOULD VOTE TO MOVE IT TO THE SECOND CATEGORY. >> SECOND. >> ALL IN FAVOR? SEVEN, EIGHT, OPPOSE? THREE, EIGHT, THREE. I WOULD VOTE THAT WE SUPPORT THE COMMITTEE'S RECOMMENDATION ON THIS WITH A BIT HORMONE EXPANDED LANGUAGE ABOUT THE JUSTIFICATION AND PERHAPS DIFFERENCE TO THE COMMITTEE MEMBERS WHO DISAGREE SOME COMMENT TO THAT EFFECT AND WE DO THAT IN AN APPROPRIATE WAY. >> SINCE WE REACH THAT DECISION ON HIPAA, THE ARGUMENT WAS THAT THE FEDERAL AGENCY LAWS, IT'S THE SAME THING, EVEN IF THIS ONE WHAT THESE LAWS SAY, WE'VE NEVER SEEN THEM, BUT THEY APPEAR TO BE LIMITED TO PRIVACY AND CONFIDENTIALITY AND THEREFORE THE IRB, THERE SHOULD BE A BROADER METHOD OF ASSESSMENT. ANYTHING OR ADDITIONAL BACKGROUND ON THIS THAT MIGHT HELP? >> I'M NOT AN EXPERT ON THESE PROVISIONS BUT IT'S BEEN TOLD BY PEOPLE WHO KNOW THESE RULES THERE ARE STRICT CONFIDENTIALITY AND I SUSPECT THEY DO THAT BEYOND THAT, THEY WOULD NOT HAVE PEOPLE REVIEWING THOSE AND SO CLEARLY YES, IF THAT'S WHAT YOU'RE WORRIED ABOUT, THEN IT'S THE SAME ANALYSIS AS WE DID BEFORE. >> I'D MOVE FOR APPROVAL OF THE SUBCOMMITTEE RECOMMENDATION. >> ANY FURTHER DISCUSSION? >> ALL IN FAVOR? ALL OPPOSE? AND ABSTENTIONS? OKAY. LET I THINK THIS ONE THEN PASSES OR SUPPORT THOSE SUBCOMMITTEE WRECK MENDATION. OKAY, WHERE ARE WE NEXT? >> SO THAT TAKES US TO EXEMPTIONS, 10 WAR D DO NOT REQUIRE THE APPLICATION OF STANDARDS FOR INFORMATION PROTECTION AND THEN 104 E MAY INVOLVE SENSITIVE INFORMATION AND DELIVER DO REQUIRE THE 105 STANDARDS OF INFORMATION PROTECTION AND THEN THE THIRD ONE IS BIOSPECIMENS, SO WE COULD ADDRESS THAT HERE. AND BEFORE THAT WE WILL GET TO THE DECISION TOOL AND I THINK IT'S WORTH NOTING AGAIN, THE 105 DATA SECURITY PROVISIONS HAVE NOT BEEN WRITTEN AND KIND OF AN UNKNOWN PROTECTION. SO THE FIRST THING TO LOOK AT IN THE EXEMPTIONS IS EXEMPTION AS 104 C ADDRESSES AN EXEMPTION DECISION TOOL THAT THE AGENCIES WILL DEVELOP, AND AN EXEMPTION DETERMINE NATIONS SHALL BE MADE BY AN INDIVIDUAL WHO'S KNOWLEDGEABLE BY THESE CATEGORY AND HAS INFORMATION AND MAKE REASONABLE DETERMINE NATION OR BY THE INVESTIGATOR ANOTHER INDIVIDUAL AT INSTITUTION ENTERS ACCURATE INFORMATION ABOUT THE RESEARCH INTO THE DECISION TOOL WHICH WILL PROVIDE A DETERMINE NATION AS TO WHETHER THE STUDY IS EXEMPT. IF THE FOOL IS USED FURTHER ASSESSMENT IS NOT REQUIRED. AND INSTITUTION OR AAPPROPRIATE, THE IRB MUST MAINTAIN RECORDS OF DETERMINE NATION AND THESE RECORDS MUST INCLUDEAD A MINIMUM NAME OF RESEARCH STUDY, INVESTIGATOR AND EXEMPTION CATEGORY ABROAD. MAINTENANCE OF COMPLETED TOOL SHALL BE CONSIDERED TO FULFILL THIS RECORD KEEPING REQUIREMENT AND WHAT CAME OUT OUTED OF SUBGROUP, AND SACHRP SUPPORTS THE USE OF EXEMPTION TOOL BASED ON EFFECTIVENESS. EXISTING VERSIONS ARE NOT ENCOURAGING. WILL THERE'S ONE THAT CAME OUT OFOXENER AND A FEW OTHERS AROUND, HOWEVER IF IT WERE EFFECTIVE IT BE USEFUL IN REDUCING BURDEN AND FURTHER MORE IT'S DIFFICULT TO TO [INDISCERNIBLE]. FELT. >> WHEN I READ THIS, I THOUGHT WHAT DOES IT MEAN EXISTS VERSIONS ARE NOT ENCOURAGINGLY BECAUSE I'M NOT FAMILIAR WITH ANY EXISTING VERSIONS, SO TO THE EXTENT THEY EXIST IS IT POSSIBLE THAT PEOPLE KNOW SOMETHING TO ARTICULATE SOMETHING ONE OR TWO OR THREE POINTS ABOUT WHAT MAKES THEM NOT ENCOURAGING SO THAT IF THERE'S INFORMATION THAT'S AVAILABLE IT COULD BE HELPFUL IN IF THE DEVELOPMENT OF THE TOOL, IT WOULD BE GREAT BECAUSE WE NEED TO ARTICULATE THAT. >> I'VE ONLY HEARD ANECDOTA COMMENTS. YEAH, I TRY TODAY, IT DIDN'T WORK. I DON'T FINISH OTHERS HAVE MORE. >> SO SO MAYBE WHAT THIS MEANS IS THAT THIS STATEMENT--SENTENCE GOES FARTHER THAN WHAT WE WANT TO SAY IF WE HAVEN'T DONE A MORE THOROUGH CANVASSING OF ALL THE ONES THAT MIGHT BE OUT THERE. I DON'T THINK IT REALLY IS CRITICAL TO OUR ARGUMENT. OTHERWISE ANY CONCERNS ABOUT THIS? CONCERNS ABOUT THE CONCERNS? >> ALONG THE LINES OF TRYING TO SUPPORT REDUCTION OF BURDEN, THERE'S A CHOICE HERE WHETHER YOU USE THE EXEMPTION TOOL OR WHETHER THE IRB MAKES THE EXEMPTION DETERMINE NATION, JUST THROWING IT OUT THERE WHETHER WE WANT TO MAKE A RECOMMENDATION ENCOURAGING USE OF THE TOOL, MAKE NOT BECAUSE WE DON'T KNOW WHAT IT LOOKS LIKE BUT IF IT WERE EFFECTIVE IF THIS SORT OF THING ALONG THE LINES THAT WHAT YOU WERE SAYING. FIRST CONCERN IS THAT IRBs MAY SUPERSEED THE AVAILABILITY OF AN EXEMPTION WHICH IS PROBLEMATIC, I DON'T KNOW IF WE WANT TO SAY SOMETHING LIKE THAT HERE OR A GENERALIZED STATEMENT THAT WE HOPE THIS WILL REDUCE BURDEN ON IRBs AND IT WILL TAKE ADVANTAGE OF IT IF IT'S A WORKABLE TOOL. SOME GENERALIZED STATEMENT ABOUT TRYING TO REDUCE BURDEN. WE COULD ENCOURAGE IRBs TO USE AN APPROPRIATE TOOL IF IT IS FOUND TO BE EFFECTIVE. >> WE COULD SAY IT CREATES AN EXEMPTION TOOL ASSUMING IT IS EFFECTIVE AND CAN SUBSTANTIALLY REDUCE THE BURDEN ON INVESTIGATORS. WELL ACTUALLY IT WOULD BE THE BURDEN ON--WELL, INVESTIGATORS AND I RBs. >> ADMINISTRATIVE BURDEN THE. >> RIGHT. >> OKAY, THEN WE GET TO THE EXEMPTIONS THEMSELVES AND AGAIN THESE WERE--WE'LL HAVE TO MOVE THIS ONE NOW. >> WELL WE DON'T HAVE TO MOVE, SO IT'S ACCEPTABLE. >> SO HERE'S THE IN ACCIDENT ONE THAT'S ACCEPTABLE AS PROPOSED. >> THIS IS D-ONE RESEARCH CONDUCTED OR ESTABLISHED COMMONLY EDUCATIONAL SETTINGS WHEN IT INVOLVES NORMAL EDSICATION MOST RESEARCH ON REGULAR AND SPECIAL EDUCATION INSTRUCTIONAL STRATEGIES AND RESEARCH ON EFFECTIVENESS OR COMPARISON AMONG INSTITUTIONAL TECHNIQUES, CURRICULA OR CLASSROOM METHODS THAT ARE LIKELY ADVERSE IMPACT STUDENTS OPPORTUNITIES TO LEARN REQUIRED EDUCATIONAL CONTENT IN THAT EDUCATIONAL SETTING AND EDITION FROM THE CURRENT D-ONE SO IT'S--AN ALTERED VERSION OF THE CURRENT D-ONE. SO RESEARCH INVOLVING 90 INTERVENTIONS INVOLVING DATA FROM AN ADULT SUBJECT THROUGH VERBAL OR WRITTEN RESPONSES AND VIDEO RECORDING OF THE SUBJECT AGREEN CELLSES TO INTERVENTION AND DATA COLLECTION AND AT LEAST ONE OF THE FOLLOWING CRITERIA AS WELL. THE SO A-INFORMATION IS OBLIGATIONS STAINED, INFORMATION OBLIGATIONS STAINED IS RECORDED IN SUCH A MANNER THAT HUMAN SUBJECTS ARE NOT IDENTIFIED OR THE SUBJECTS OR B ANY DISCLOSURE OF IT IS RESEARCH WOULD NOT DISPLACE THE SUBJECTS AT THE ADVERSE RISKS WE HAD OVER THE YEARS. THERE IS A TWO THERE, SO FOR THE PURPOSE OF BENIGN INTERVENTIONS ARE BRIEF IN DURATION, NOT INVASIVE AND LIKELY TO HAVE A SIGNIFICANT IMPACT ON THE SUBJECTS AND NO REASON TO THINK THE SUBJECTS WILL FIND THE INTERVENTIONS OFFENSIVE, AND THEY MIGHT INCLUDE ACTIVITYINGS SUCH AS SUBJECTS ASK TO READ MATERIALS, LOOK AT PICTURES, PLAY ONLINE GAMES, ALL FORMS, AND THIRD IF THE RESEARCH INVOLVES DECEIVING THE SUBJECTS REGARDINGINATE AND YOU ARE PURPOSE OF THE RESEARCH THIS EXEMPTION IS NOT APPLICABLE UNLESS THE SUBJECT AUTHORS THE DECEPTION DESCRIBED IN THE PARAGRAPH. NEXT PARAGRAPH FFOR THE PURPOSE OF THIS PROVISION, AUTHORIZE A DECEPTION IS PROTECT SPECTIVE AGREEMENT BY THE SUBJECT TO PARTICIPATE IN RESEARCH WHERE THE SUBJECT IS INFORMED THAT HE OR SHE WILL BE UNAFARE. >> I DON'T OBJECT TO THIS BEING AN EXEMPTION BUT THIS IS ONE PLACE WHERE I THINK IT'S REALLY CLEAR THAT THE WORD INTERVENTION THROUGHOUT THIS SET OF EXEMPTIONS AND EXCLUSIONS, THE WORD INTERVENTION IS USE INDEED A VARIETY OF WAYS AND INCONSISTENT AND UNCLEAR. AND I THINK TYPICALLY WE'RE USED TO THINKING ABOUT INTERVENTION AND INTERACTION WITH A SUBJECT ALTOGETHER AND SO, WE OFTEN DON'T REALLY TRY TO DISTINGUISH WHAT COUNTS AS AN INTERVENTION AND WHAT COUNTS AS INTERACTION BECAUSE AND I THINK SOMETHING LIKE PLAYING A GAME COULD BE VIEWED AS EITHER AN INTERVENTION OR AN INTERACTION AND I THINK IN REDRAFTING THESE TO BE A FINAL RULE, THERE ARE MANY PLACES WHERE THAT WORD WILL SAY, NO INTERVENTION AND THEN IT WILL LIST A BUNCH OF THINGS THAT I THINK ARE EQUIVALENT OF SOMETHING LIKE PLAYING A GAME OR WHATEVER: EXPO SO I JUST THINK WE NEED TO BE CLEAR IN THE REDRAFTING HERE. SO THAT DOESN'T GO EXPLICITLY TO THIS ONE BUT WHEN I WAS READING THIS ONE AND IT WAS TALKING ABOUT BENIGN INTERVENTIONS THAT I FELT LIKE THERE'S A LOT OF CONFUSION IN THE USE OF THAT TERM THROUGHOUT. >> [INDISCERNIBLE] >> YEAH, I DON'T KNOW QUITE WHERE I WOULD PUT IT BECAUSE I THINK--SOMEWHERE IN THE INTRODUCTION TO THE WHOLE DISCUSSION OF EXCLUSIONS OR EXTENSIONS, I WOULD JUST PUT A SENTENCE THERE, ABOUT THAT AND I CAN--I COULD ACTUALLY GIVE YOU LANGUAGE BECAUSE I WAS WRITING DOWN EXAMPLES OF PLACES WHERE I THINK THERE IS CONFUSION ABOUT THAT. >> ALL RIGHT MOVING ON TO D-FOUR, THIS IS THE CURRENT, D-SIX AND UNCHANGED TASTE IN FOOD QUALITY EVALUATIONS, CONSUMER ACCEPTANCE TESTS. THEN WE GET TO 104 E-ONE WHICH APPLIES TO RESEARCH NOT INCLUDING INTERVENTIONS INVOLVING THE USE OF EDUCATIONAL TESTS, DIAGNOSTIC PROCEDURES, INTERVIEW PROCEDURES OBSERVATION OF PUBLIC BEHAVIOR IF THE INFORMATION OBTAINED IS RECORDED IN SUCH A MANNER THAT HUMAN SUBJECTS CAN CAN BE IDENTIFIED DIRECTLY OR THROUGH IDENTIFIERS-LINKED TO THE SUBJECTINGS IF YOU NOTICE, THE FACT THAT DISCLOSURE TO THE SUBJECTS WILL NOLL HARM THE SUBJECTS. THE IDEA BEING HERE THAT IF PEOPLE DON'T WANT TO PARTICIPATE, THEY WILL SAY NO. >> OKAY. >> E-TWO APPLIES TO SECONDARY RESEARCH USE OF IDENTIFIABLE PRIVATE INFORMATION HA HAS BEEN OR WILL BE ACQUIRED FOR NONRESEARCH PURPOSES IF THE FOLLOWING KRIST FERIA ARE MET. PRIOR NOTICE HAS BEEN GIVEN TO INDIVIDUALS FOR WHOM IT OBTAINS AND THAT INFORMATION MAY BE USE INDEED RESEARCH AND THE IDENTIFIABLE PRIVATE INFORMATION IS USED ONLY FOR THE PURPOSES OF THE SPECIFIC RESEARCH FOR WHICH INVESTIGATOR OR RECIPIENT IN THE REQUESTED ACCESS TO [INDISCERNIBLE]. AND THE LAST STATEMENT WAS THAT WHEN WE SUPPORT THIS, BUT BELIEVE IT FURTHER DISCUSSION OF THE NOTICE REQUIREMENTS IS WARRANTIED. BUT THERE'S NO DESCRIPTION OF IT. >> SO IF THIS WERE COVERED BY THE NOTICE WE'VE TALKED ABOUT, IF THE NOTICE WE TALKED ABOUT WERE BIOSPECIMENS, WAS EXPANDED TO COVER THIS KIND OF THING, THEN, I--IT SEEMS TO ME THAT KIND OF NOTICE WOULD BE ACCEPTABLE. >> SO SACHRP SUGGESTS THE NOTICE-- >> BUT JIM DO YOU MEAN THE NOTICE AND THE OPT-OUT OR JUST THE NOTICE PART. >> I THINK I MEAN THE NOTICE. BECAUSE THESE ARE THIS IS A PLACE WHERE BIOSPECIMENS AND DATA IS DIFFERENT IF THIS IS DONE--IF THIS IS ACQUIRED FOR NONRESEARCH PURPOSES. THERE'S--I THINK, IN A HOSPITAL SETTING IT'S TYPICALLY THE CASE THAT THE SPECIFIED RESEARCH PURPOSES MOST OFTEN USING DEIDENTIFIED DATA AND I THINK IN THIS SETTING NOTICE IS SUFFICIENT. >> DON'T OUR RECOMMENDATIONS FROM YESTERDAY PRECLUDE THIS--NOT PRECLUDE IT BUT DO OFFER AND OPT OUT IN THIS CONTEXT, SO I THINK--THIS PARTICULAR EXEMPTION IS NOT CONSISTENT WITH WHAT WE ARE RECOMMENDING IN THE BIOSPECIMEN DOMAIN. >> ONE THING TO DO IS RELY ON THE FACT TAKEN--THEY WE OPEN THESE UP AND THESE ARE ALL SUBSERVE QUINTTO THE WRECK MENDATIONS MADE PREVIOUSLY ABOUT BIODATA AND LEAVE IT AT THAT. >> AND I JUST NEED CLARIFICATION, SO WHAT DO WE MEAN BY ENTITY ACCESS IN THE INFORMATION IS THAT ACCESS IN THE NOTICE OR THE SPECIFIC RESEARCH STUDY THAT WE'RE TALKING ABOUT AND IF IT'S THE LATTER, WHY DO WE--ISN'T THAT IMPLICIT? >> I THINK THE IS SHE THAT YOU CAN ONLY USE IT FOR THAT PARTICULAR PURPOSE AND THEN YOU HAVE TO FILL OUT ANOTHER EXEMPTION FOR YOUR NEXT INTENDED USE OF THAT DATA OR SIMILAR DATA. >> YOU CAN'T GET IT ONCE AND THEN KEEP USING IT. >> OKAY. >> SO WHAT WOULD BE A COMMON EXAMPLE HERE. WHAT SORT OF ACQUISITION OF DATA IN A NONRESEARCH PURPOSES IN THE SECONDARY. >> MEDICAL RECORDS TO INCLUDE [INDISCERNIBLE] SO INSTEAD OF LEAVING THE MEDICAL ROOM WITH ALL THE IDENTIFIERS STRIPPED OFF, YOU LEAVE WITH IDENTIFIERS STILL ON. THEY'RE IN YOUR RESEARCH DATA SET. AND WHAT SET OF RESEARCH IS COMMONLY KNOWN. >> SCHOOLS, HOSPITALS, PUBLIC HEALTH CLINICS. >> I MEAN-- >> EXAMPLE WOULD BE TO FOR INSTANCE LOOK AT CONTROL PF A-ONE C IN POPULATION OF PATIENTS WITH DIABETES. PERSPECTIVELY YOU HAVE THE IDENTIFIERS SO CAN YOU GO BACK AND GET MORE INFO. >> YEAH, SO I THINK I WAS GOING TO FOLLOW UP AND SAY SOMETHING SHRIEK THAT WHEN YOU NEED TO FOR INSTANCE LINK BACK TO A PERSON MEDICAL RECORD PERIODICALLY AND IDENTIFY DOESN'T MEAN IT HAS THE PERSON'S NAME ATTACHED. USUALLY IT'S GOT SOME NUMBER, SOME CODE NUMBER, BUT BECAUSE IT'S ALL WITHIN OUR RESEARCH INSTITUTION AND YOU HAVEN'T SIGNED AN AGREEMENT SAYING THAT YOU'LL NEVER--THAT YOU DON'T HAVE THE KEY AND YOU CAN'T REIDENTIFY, THEN AT LEAST UNDER THE CURRENT RULE THAT COUNTS AS IDENTIFIABLE WITH A CODE ON IT SO IT'S NOT THAT--I THINK--ALL THE RESEARCHERS THAT I KNOW DO NOT WANT TO BE WORKING WITH INFORMATION THAT HAS IDENTIFIERS ATTACHED TO THIS THAT COULD EASILY BE USED TO, YOU KNOW LINK RESEARCH INFORMATION TO A PARTICULAR INDIVIDUAL, BUT STILL WHEN IT'S FLOATING AROUND IN YOUR INSTITUTION THAT YOU HAVE THE DESCRIPTION KEY SOMEWHERE, THAT COUNTS AS IDENTIFIABLE RIGHT NOW. >> OKAY, I THINK WE HAVE ABOUT 15 MINUTES TO FINISH UP WITH THE SET OF STATEMENTS SO I THINK WE'RE GOING TO--DAVEED, I KNOW YOU NEATED AT SOME POINT, THAT MAYBE JUST IN YOUR HEAD THAT WE'RE GOING TO MAKE A REFERENCE TO OUR BIOSPECIMEN STATEMENT HERE. >> I TOOK IT OUT. >> WHAT'S THAT. >> I TOOK IT OUT ON THE IDEA THAT IT'S SUBSERVIENT. >> OH BECAUSE WE SAY THAT ELSEWHERE. >> IF THOSE ARE ADOPTED. >> AND THEN IT WILL BE A FRANK DISCUSSION. >> OKAY, MOVING ON. >> WE HAD NO MINOR PROPOSED MODIFICATIONS IN THE EXEMPTIONS AND THEN, WE GOT TO A DISCUSSION OF AN EXEMPTION WE DID NOT BELIEVE WAS ACCEPTABLE. >> AND THIS IS 10 FAFF D-TWO AND IT'S THE CURRENT 104--101 B-FIVE WITH SLIGHT CHANGES. >> RESEARCH AND DEMONSTRATION PROJECTS THAT ARE CONDUCTED OR SUPPORTED BY A FEDERAL DEPARTMENT OR AGENCY OTHERWISE SUBJECT TO THE APPROVAL OR AGENCY HEADS THAT ARE DESIGNED TO STUDY EVALUATE OR OTHERWISE EXAMINE PUBLIC SERVICES INCLUDING PROCEDURES UNDER THE PROGRAMS OR POSSIBLE CHANGES IN ALTERNATIVE TO THOSE PROGRAMS OR PROCEDURES OR POSSIBLE CHANGES IN METHODS OR LEVELS PAYMENTS OR SERVICES IN IF THE PROGRAMS. >> AND THEN ALSO ADDED EACH FEDERAL DEPARTMENT OR AGENCY CONDUCTING OR SUPPORTING RESEARCH DEMONSTRATION PROJECT MUST ESTABLISH ON A PUCK LIE ACCESSIBLE SIMILAR MANNER, A LIST OF RESEARCH AND TEMONSTRATION PROJECTS THAT THE FEDERAL DEPARTMENT AGENCY CONDUCTS OR SUPPORTS THUNDER PROVISION, THE RESEARCH OR DEMONSTRATION PROJECT MUST BE PUBLISHED ON THIS LIST PRIOR TO OR WITH THE TREMENDOUS RESEARCH, AND SUBCOMMITTEE LEVEL WE HAVE ASCHRP THERE, THERE WAS SIGNIFICANT CONCERN ABOUT THE PROPOSED REVISED EXEMPTION AND HAVE THE FOLLOWING RECOMMENDATION: THE EXEMPTION SHOULD BE LIMITED TO RESEARCH THAT PRESENTS NO MORE MINIMAL RISK TO SUBJECTS AND CONSENT REQUIRED TO RESEARCH OTHERWISE EXEMPT ON 10 FAFF D-TWO UNLESS WAVED IN ACCORDANCE WITH THE STANDARDS IN 116 E-ONE AND THE PRIVACY PROTECTION SPECIFIED IN 105 SHOULD APPLY TO RESEARCH UNDER THE EXEMPTION AND IF THE PUBLIC NOTES, THE PUBLIC POSTING OF THESE STUDIES IS UNLIKELY TO HAVE IT. >> WELL THE WHOLE ROM ANET ONE IS IN THIS EDITION AND I'M FORGETTING THE FACT DIFFERENCES IN THE FIRST PART. THERE WERE A FEW. ANYONE AROUND THE TABLE--I DON'T HAVE MY MATERIALS IN FRONT OF ME. >> THE BIGGEST WAS BEFORE IT WAS LIMITED TO WHAT THE ACTUAL AGENCY CONDUCTING THIS STUDY AND NOW IT ACTUALLY COVERS THE FUNDING THE STUDY, IS THAT RIGHT--HOW IT'S CONDUCTED OR SUPPORTED. >> AND EVEN THAT WAS A LITTLE FUZZY BECAUSE IT DID SAY SUPPORTED BY PREVIOUS, AS LONG AS AGENCY-- >> SUPPORTED BY-- >> I THOUGHT IT DID. >> OKAY. >> I THINK IT DID. >> NOW THERE WAS AN OLD GUIDANCE OUT THAT IMPOSED FURGTDER LIMITATIONS ON THIS, AND THAT A LOT OF IRBs WORKED IN THE SOPs SO THAT WAS THE MAJOR DIFFERENCE FROM OUR VIEW POINT THERE WAS A REASON THAT YOU DON'T CARE FOR IN MAKING THIS PUBLIC, I THINK IT YOU WELCOME DISCUSSIONS THAT THIS IS RARELY USED AND WELL, ACTUALLY THERE ARE A LOT OF STUDIES THAT COME UNDER THIS IN THE CONCERNS THAT NOBODY KNOWS WHAT THESE STUDIES ARE AND IF THEY'RE ON THE PUBLIC DATABASE SOMEWHERE, RESEARCHERS AND LITTLERS AND PEOPLE IN THE MEDIA COULD LOOK AT THIS AND SAY, WOW, THIS IS WHAT IS HAPPENING UNDER THIS AND THEN YOU COULD ENGAGE IN FURTHER DEBATE ABOUT WHETHER THESE ARE STUDIES THAT SHOULD BE EXEMPT AND THAT WAS WHY IT'S PUT UP FOR DISCUSSION, THE ISSUE OF THE MINIMAL RISK, PRECISELY BECAUSE THESE ARE INTERVENTIONAL STUDIES, THEY'RE UNUSUAL TYPES OF INTERVENTIONS, SOME OF THEM AND PROBABLY MOST OF THEM RELATE TO KIND OF FUNDING MECHANISMS AND THAT SORT OF THING. BUT THAT GETS INTO MORE TYPES OF MEDICAL CARE IF SOMEBODY DOES OR DOESN'T GET AND THAT'S WHAT CAN HAPPEN WITH THE STUDY. >> SO I GUESS, YOU KNOW THAT WAS WHERE THE DEBATE AT THE SUBCOMMITTEE LEVEL WENT. ALL THE ONES I'VE SEEN IN NIGH CAREER HAS BEEN BASICALLY RECORDS REVIEW, COULD HAVE BEEN UNDER B-FOUR OR--THEY WERE GENERALLY BENIGN, BIG DATA SETS BEING LOOKED AT BUT WHAT THIS--MANY OF THE SUBCOMMITTEE MEMBERS POINTED OUT IS THAT YOU CAN DO A RANDOMIZE TRIAL IN PUTTING PEOPLE IN DIFFERENT BENEFIT LEVEL. >> YEAH. >> IT WOULD SEEM TO ALLOW IT. >> YES, IT CLEARLY DOES COVER--YOU'VE CLEARLY SEEN A SUBSET OF THE CHANGE, I MEAN SPECIFICALLY, IT GOES WAY WAY, WAY, BACK, BUT THE CHANGE IS RIGHT, ONE FEDERAL ENTITY DOES OR DOES NOT COMPENSATE FOR A PARTICULAR MEDICAL PROCEDURE AND THAT WILL EFFECT WHO GETS THE MEDICAL PROCEDURE AND WHAT SHOULD BE THE RESTRICTIONS ON THIS THING BUT THIS GOES WAY BACK IN TERMS OF WELL, THESE ARE BENEFITS PROVIDED BY THE FEDERAL GOVERNMENT FOR PEOPLE, THE AGENCIES THAT PROVIDE INCENTIVES THAT WERE GIB A IS SHE LEVEL OF AUTHORITY TO DO THAT AND COULD DO CERTAIN THINGS TO MAKE SURE THE BENEFITS THEY PROVIDE ARE POSSIBLE AND ACHIEVING THE GOAL I MEAN THAT'S AGAIN A LONG STANDING EXEMPTION. OUR MEAN GOAL WAS TO MAKE IT MORE TRANSPARENT IN WHAT WE'RE TRYING TO DO, AND A LOT OF STUDIES PEOPLE OBSERVING IN THE POSITION YOU DON'T SEE ACTUALLY WITH THAT. , SO THE POINT OF THE SUBCOMMITTEE RECOMMENDATION IS ACTUALLY TO STRENGTHEN WHAT WOULD BE THE EXISTING REGULATIONS HERE IN ADDITION TO THE LAST SENTENCE HERE IT DESERVES MORE DISCUSSION ABOUT WHETHER IN FACT AS JERRY SAYS, MAYBE THIS WILL DO MORE BENEFIT THAN HAS BEEN ANTICIPATED BY THE SUBCOMMITTEE, SO LET'S SEE WHERE WE ARE WITH THOUGHTS ON THIS PROPOSAL. >> I'M STILL A LITTLE CONFUSED. SO SO THERE ARE--IT WAS HELPFUL TO HEAR THE EXAMPLES, BUT WITH THE PROPOSAL IT HAS TO BE LIMITED TO MINIMAL RISK OR GET A WAIVER THAT WOULD REQUIRE THE MINIMAL RISK, ARE THERE IMPORTANT SORT OF BENEFIT STUDIES THAT NEED TO BE DONE THAT THEN WOULD BE PREVENTED BECAUSE YOU SAY IF YOU'RE GOING TO ONE--ONE IMPORTANT THING IS TO DETEAM PAYMENT FOR AN INTERVENTION IS THE RIGHT THING TO DO AND SOME GROUP WILL GET PAID FOR IT, THAT'S GOT TO BE MORE THE MINIMAL RISK AND HOW DO YOU GET CONSENT FOR THAT. SO WE WILL--THAT PREVENTS THINGS FROM BEING DONE. >> YES. >> NOT SPEAKING FOR THE PARTS OF THE FEDERAL GOVERNMENT THAT DO THESE STUDIES, I SUSPECT THEY WOULD CLEARLY INTERNATIONAL CLASSIFICATIONICATE FROM THEIR REVIEW POINT. F IF YOU PUT A MINIMAL RISK LIMITATION, IT WILL PREVENT STUDIES THAT THEY THINK ARE IMPORTANT. >> AND JUST GET SOME SORT OF COMPLICATED DISCUSSION OF HOW THE MINIMAL RISK APPLIED TO THIS SORT OF STUDY BUT THEY WOULD CLEARLY HAVE CONCERN IN TERMS OF POSING THAT AND AGAIN I DON'T WANT TO SPEAK FOR THEM BUT-- >> WELL, JUST TO-- >> I WAS JUST GOING TO ADD THAT I THINK ONE OF THE THINGS THAT'S MISSING FROM THIS IS DIFFERENT FROM THE CURRENT EXEMPTION IS THAT THIS INCLUDES BIOSPECIMENS AND THIS DOESN'T SAY THAT ON THAT PAGE BUT IF YOU LOOK AT THE ACTUAL CODIFIED IT SAYS ONLY D-TWO FOR BIOSPECIMEN SO IT MAKE ITS MORE COMPLICATED AND BRINGS THEM IN DISCUSSION ABOUT WHAT WE HAD YESTERDAY ABOUT BIOSPECIMENS. >> OKAY, SO THE THRUST OF THIS THOUGH IS THAT IT'S GOING TO BE EXEMPT ONLY IF IT'S MINIMAL RISK. IF IT'S NOT MINIMAL RISK THEN IT GOES TO IRB OVERSIGHT. THE WAIVER CRITERIA, SO WE'RE SUGGESTING THAT THE WAIVER CRITERIA BE APPLIED OTHERWISE INFORMED CONSENT BE OBTAINED SO THERE'S A COUPLE LEVELS OF THIS RECOMMENDATION THAT WE NEED TO THINK THROUGH INDIVIDUALLY, ARE PEOPLE CONVINCE THAD PRECLUDING RESEARCH BY THE INABILITY TO GET INFORMED CONSENT IS IMPORTANT, OBVIOUSLY THAT'S SOMETHING THAT WE UNDERSTAND AND IN THE LARGELY FEAR IS THAT PEOPLE DON'T WANT TO SIGN UP FOR A PROGRAM, WE LET THEM MAKE MA DECISION, THIS DIFFERENCE IN SOME SUBSTANTIVE WAY BECAUSE OF HOW THE GOVERNMENT WANTS TO CONDUCT A STUDY WITH RESPECT TO ITS RESOURCES PAYING FOR FOR DIFFERENT TYPES OF CARE IS THAT SOMETHING THAT SHOULD BE APPROPRIATELY EXCLUDE FOR INFORMED CONSENT DOMAIN. >> I HAVE A HARD TIME UNDERSTANDING HOW PEOPLE CAN OPT-OUT. I MEAN, CAN I CALL UP THE VETERAN'S ADMINISTRATION AND SAY, I GUESS I WAS RANDOMIZED TO THIS PARTICULAR WAY OF REIMBURSING ME FOR MY MEDICAL EXPENSES BUT ACTUALLY I WOULD PREFER YOU REIMBURSE ME IN THIS WAY WHICH IS THE OTHER RANDOMIZED GROUP. HOW IS THAT GOING TO LOOK? >> I WOULD ULTIMATELY ACTUALLY PROPOSE WE DON'T MAKE A RECOMMENDATION BASED ON THIS. I THINK IF IT'S AN EXISTING EXEMPTION, THEN WHY THE PARTIES CAN CONTINUE IN THIS EXEMPTION. WE ALL SEE THIS AS HUMAN SUBJECTS RESEARCH WITH RISK, WE'RE ASSUMING THAT LIKE EVERYTHING ELSE, WE ARE CONSENTED AND ALL OF THAT MAKES SENSE BUT I DON'T FEEL LIKE WE HAVE AT THE TABLE, THE PEOPLE WHO WOULD SPEAK TO WHY THIS SHOULD REMAIN EXEMPT SO I'M CONCERNED ABOUT MOVING FORWARD ON THOSE TERMS. >> SEEING A FEW SHAKING HEADS TO THIS, WOULD WILL WE WANT TO RESTRICT OUR SUPPORT TO THE PUBLIC NOTICE PIECE AND AS JERRY SAID THAT WAS PART OF WHAT WAS SUPPOSED TO IMPROVED GREATER ELAPPROPRIATE RISK FOR WHAT THE SACHRPBELIEVES IS INAPPROPRIATE? MEASURE, SOMETHING TO THAT EFFECT? >> SO THE STUDY TITLES OR SOME ABSTRACT LIKE OVERVIEW OR DESCRIPTION INSPECT. >> I DON'T RECALL WHAT DETAIL WAS SAID BUT I ASSUME IT WOULD BE AT LEAST A STUDY TYPE, SOME HINT OF WHAT'S GOING ON AND PRESUMABLY ONCE YOU HAVE THAT, I SUSPECT THERE IS PUBLICLY AVAILABLE INFORMATION ELSEWHERE ABOUT THESE STUDIES SO PEOPLE COULD PROBABLY FIND OUT ABOUT IT. AND THAT'S MY SENSE OF IT. BUT YOU COULD CERTAINLY SAY MORE IF YOU WANT TO MAKE THAT TRUE. I THINK GIVEN THE NATURE OF THESENTITIES AND THE STUDIES THEY DO AND THE ACTIVITIES THEY DO, I THINK A LOT OF THEM ARE VERY PUBLIC BUT GIVEN THE MASSIVENESS OF--IT COULD BE SOMEWHERE THAT PEOPLE ARE NOT EASILY AWARE, IF YOU HAVE IDENTIFICATION, OR LOOK UP THE PROTOCOL SOMEWHERE ELSE, ALTHOUGH THAT'S PROBABLY--PEOPLE ARE CONTEMPLATING THE WEB SITE TO KNOW THAT THE PART WOULD HAVE ALL THAT DETAIL. >> AM I HEARING ENOUGH OF A CALL HERE TO MOVE THIS UP INTO THE CATEGORY WITH NO SUGGESTIONS, NO PROPOSED MODIFICATIONS? >> I THINK SO AND IT'S MORE, PART OF THE ISSUE IS WE DON'T UNDERSTAND ENOUGH TO GIVE IT OUR STRONG SUPPORT OR TO NECESSARILY CRIT SIZE IT BECAUSE IT'S KIND OF BEYOND OUR CAPABILITIES, SO, OTHER THAN PERHAPS THE ELEMENTS SAY, IT SOUNDS LIKE THE PUBLIC POSTING IS A GOOD IDEA. OKAY, ANY OTHER DISCUSSION ON THIS ONE? OKAY. EXCELLENT. SO I THINK WE HAVE ALREADY TAKEN A VOTE ON A COUPLE OF THESE, SO, I WONDER IF IT WOULD BE APPROPRIATE STRATEGY TO SAY, FOR THE REST OF THEM, WE'RE GOING TO PUT THEM INTO A GRAB BAG HERE AND VOTE ON THEM AS A PACKAGE? SECONDS? >> FURTHER DISCUSSION, ALL IN FAVOR OF THE REST OF THE PACKAGE? >> OPPOSE? ABSTENTIONS? >> OKAY, EXCELLENT WORK. DAVID, THANK YOU AND THANKS TO THE SUBCOMMITTEE FOR ALL THE THOUGHT THAT WENT INTO VERY COMPLICATED SET OF PROPOSALS AND CONSIDERATIONS. >> WE ARE REMARKABLY AT LUNCH TIME. AND SO, WE HAVE A WORKING LUNCH AND I THINK PARTICULARLY IMPORTANT TODAY GIVEN THE FACT WE HAVE FOLKS WHO MAY NEED TO LEAVE US EARLY. SO OUR PLAN IS TO PROCEED WITH GETTING LUNCH FOR THE COMMITTEE MEMBERS AND RETURN AND WE WILL START WORK AT 12:30 AND WE WILL START WITH PUBLIC COMMENT AND PROCEED ON TO THE INFORMED CONSENT AND CONTINUING REVIEW DISCUSSION. SO, 12:30. >> We voted on exclusions and exemption prior to the time David perhaps made final edits so we may need to relook at those and potentially revote if there's been any substantive changes in those so the final version is the one we're voting on. so we're going to welcome public comment and just to note that folks who submit written comments, all of those are provided top it the committee members and those are all available for members of the public who request them. that's consistent with the federal advisory committee act and so folks can have access to those through that mechanism. we're going to invite just two comments at this point. we'll have later opportunity for other public comment. and given our time constraints I'll limit the comments to five minutes each and I'll give the speakers a notice when we're about one minute into that. that of course is not because we don't want to hear from the public but because we have a tight agenda and in fairness to the committee's business and fairness to other people who want to make public comment, we want to have appropriate limits on the time for speakers. so Gary Chadwick is up. >> Okay. again, my remarks only reflect my personal opinion. listening to your extended discussions today, I'm convinced that what the NPRM proposes is a bad idea and should be abandoned. it confuses issues by using undefined terms as low risk, benign intervention, adding a new classification of excluded and redefining and ordering exemption and loading on exemption conditions adds complexity and is harder to understand and apply. the value of trying to be compliant will suffer. let's be bold. I suggest we revise the current 101b to declare research is exempt if involves adult subjects, no kids, who are not prisoners, research does not expose subjects others to greater than minimal risk. I'm suggesting exempting minimal risk. it seems like a great leap but is it really? Minimal risk is what each of us deals with every day. why can't we eliminate the countless hours spent dithering just because they are research. HHS should eliminate initial review as well. specific investigator responsibility to be added to the common rule to harmonize with F.D.A. regulations like the F.D.A. model, non-compliance could be enforced, more importantly for those who fail to follow basic human subject protection. debarment, temporary limited or permanent may be appropriate as remediation I the NPRM proposals would add complexity, confusion, frustration, and inevitable non-compliance. HHS should develop guide research protections 120415-- regulations to address the mechanism, institutions might use. I believe transparency is desirable but the solution is across the rails. a better solution with F.D.A. regulations and NIH policy would be to require posting of the consent forms only for clinical trials that are required to be listed on clinicaltrials.gov. unlike the NPRn nothing new needs to be added to the current system. the website exists, procedures exist for identifying and posting the appropriate clinical trials, responsible parties are identified and trained, and both the original draft form and a final version of the form could be posted. the draft at the initial registration and final if and when results are posted. next, the NPRm proposal in the consent requirements paragraph at the beginning of section 115 has the spark of a good idea but the NPRM proposal that information required by the regulations be the only content of the consent form and additional information be be in appendix ignores that they only now contain information tagged to required elements. the proposed new wording will not decrease the bloat. the Nrpm suggests HHS templates, perhaps a form that documents concept has taken place, required information was given, questions answered. that templated one page would be the consent form. and all information given in the consent process would be placed in the appendix. so not a long form, not a short form, but a Goldilocks form. the NPRm proposal to change 116d waiver criteria is a bad idea. leave the waiver criteria as it is, take the biospecimens complexity out, and put it in a new subpart. if it takes another four years to bring the both specimen related proposals to where they can be floated in another NPRm so be it. again I strongly urge HHS to public a new NPRn or break up the plethora of ideas both the good and not so good presented in this notice into a series of shorter NPRns with specifics, not questions, no undeveloped promiseory deliverables, as your discussions, questions and I don't understands and I'm still confused remarks indicated, with a few exceptions this NPRn is not ready for final rule making. as happened yesterday I left out many details because of time but if you would like to see my full comments please ask Ohrp for a copy. Julie's home phone number is ... [Laughter] >> Thank you, Gary. Mr.Dawson. >> I speak on behalf of all targets we don't want exclusions for intelligence agencies, they are the primary source of non-consensual human experimentation in the United States past and present. we want more protection, not less. and we want a knowledgeable commission about military and intelligence agencies, maybe a special forum, a special advisory board, or something that can speak to this issue. U.S. law policies regulations do not allow human sacrifices, for national security. what they are doing to us is unlawful, immoral and unethical. and then these are my comments. I'll try to go fast. yesterday I mentioned seven considerations, classified research or clandestine use of contractors, history of breaking laws, scattered targets and targeting for retaliation. remote and visible and technologically advanced technology and weapons. seeking help from committees and having conflicts of interest, and credibility of human subjects. today I'm just going to talk about some evidence that was mentioned in the federal registry. we have whistleblowers and this distinguishes us from conspiracy their reises. we have Mike German, Thomas drape, William biddy, John McClaire Robert Duncan, Jeffrey sterling, Kurt, Barry, Ted Gunderson, and these are long-term careerists from these organizations. high level. so these are not just, you know, somebody's friend or something like that. these are high level long-term careerists. the technology exists of what targets they are talking about. we have patent numbers. some of our FOIA requests have been answered, I used one in my comment in October. there's been symposiums on directed energy weapons, the future of the battlefield is in the brain and mind behavior and Siops, everything for the military's future is being done to us. we do know that there's research on this technology. Google directed energy weapons and biobehavior research and human effects and you'll see it. I had one that came up. there's contracts. there's been reports and events that have discussed these issues. the Geneva forum, Harvard humanitarian initiative, and so forth. we have some journal articles, news articles, journal of psychosocial studies, and I just recently read that and there's nine experts quoted in there. Leonard Rubinstein at Johns Hopkins university, Dr. Cherubini who was awarded the award of courage or something, and I noted his wife has a comment in the public comments. Jonathan Moreno biomedical expert discussing the next generation of weapons, I want to point out there are experts. there have been lawsuits, Jesus Mendoza claimed he was being electronically arrested, and its involves his children, a target area. James wellbert, Jane cliff in the United Kingdom won her lawsuit. currently veterans are suing the CIA over mind control experiments. and the two psychologists who experimented with prisoners with enhanced interrogation which the media is now calling non-consensual human experimentation including the nation, they are being sued so we are going to start holding people accountable. especially health professionals and any of those who are in their positions and earning money to protect human subjects. there have been some laws, Michigan has a law against electronic harassment. Berkeley has a law from 2002 in regard to the space above Berkeley. there was an outer space treaty of 1967 that has a loop hope and every time there's a loop hope the United States will find it. in 1999, the space treaty, the United States did not sign it. we've been trying to pass almost -- >> One more minute. thank you. >> The CIA has broken its own policy, using torture, assasination, non-consensual human experimentation. they have made exceptions. they have-- I can't read my writing. they have manipulations of terms I think we've mentioned human subject, human beings. in regard to their surveillance, space based lasers have to be on satellites, the same satellite that is used for surveillance, so there are ways for them to get around this. as I mentioned they don't follow any of the rules right now. Tyler verse U.S. the United States said no surveillance could go through the walls, infringing on I believe the fourth amendment yet they are still doing it. that's a Supreme Court case. in summary, the CIA can neither-- sorry, the CIA can neither confirm nor deny allegations as human subjects. hopefully this could be a recommendation to the secretary. HHS. in the context of the history, they need to have oversight and you need to be aware of what they have done in the past and future, current and future. you need to be knowledgeable about this in order to help us and you can't have conflicts of interest. the new targets, they are not institutionalized people, they are scattered. it's for retaliation. these are remote advanced invasive and that needs to be taken into consideration, where do we get support? We have no medical, legal, social support. and credibility. >> Thank you. >> Last sentence. last at your own peril, because this is not just about me, the targets it will affect humanity. look at the ethics, is it eugenics, behavior control and manipulation, economy, privacy, ensure it stays in the right hands, protect intellectual property and protect privacy and the constitution. thank you. >> Thank you. again, please submit given our limited time here, please submit whatever you wish in written form to be districted to committee members and available to the public. we're going to now turn to informed consent. and David Borasky is going to lead. >> Thanks, Jeff. okay. we've got some recommendations. hopefully you looked at them in advance, in the days leading up to the meeting I received a couple of various comments from some of the SACHRP members. so if I don't touch on those bring them up and share them with the group. we started by talking about the requirement that informed consent documents should be limited to the elements of consent with other information, moved to an appendix to support the goal of having substantially shorter consent forms with subjects receiving the most important information in the body of the relatively short forms, instead of that key information being buried in a long and overly complex document. the NPRm proposes informed consent forms be written understandable and in a manner consistent with guidelines and federal plain writing act of 2010. and there's also the proposal that elements required under HIPAA would become considered to be equivalent to the 116 required elements for combined-- forms that combined informed consent and HIPAA authorization so HIPAA information would not end up in appendix as well. in general so for this piece the proposal, SACHRP supports this proposal and recommends Ohrp develop guidance on implementation including the role in evaluating nature and volume of information included in appendix, so that conclusion partly comes from our last meeting where we talked about operationallize and the role of the IRB. let me stop and I think this is where we got to at the last meeting. I want to confirm that's the case and see if there's any additional comments. Pilar? >> One brief point not to a recommendation but the regulatory language itself doesn't say anything the federal plain language guidelines and federal plain writing act. it does talk about that in the introductory kind of commenting area but it's not part of the regulatory language so I don't know that we require that under the regulations. I just was wondering if we needed to leave the last sentence of the first paragraph in there. >> It's a good question. Gerry, I don't know if you want to comment on that and how that would be perceived part of the regulation. >> I wasn't aware it was a regulatory requirement that we were imposing that. >> I would say just to be clear, so, Pilar, in that paragraph I don't mean to imply it would be a regulatory requirement, I guess I could be clear in the background information that the body of the NPRm versus proposed regulations it suggests that consent forms would be required to meet these standards but the proposed regulatory language does not mirror that. >> Is there any way to-- is there a fix here? I don't know that it's a problem but is is there a way to make it clearer? It tends to suggests this is a new standard applied to consent forms when it's suggestion this is the goal be consistent with language. >> Except I think the language, I don't have the NPRm in front of me but I think the language in the body of the NPRm does suggest this would be the standard by which consents would have to be written. it didn't make it into-- I don't believe into equivalent language in the proposed regulation itself. >> The preamble, we talked about it. >> Yeah. >> Okay. I can hear the preamble. >> That may be sufficient given the fact that everybody understands the preamble isn't regulatory code. we're checking here quickly. >> We can move on. >> That's something that should be easy to clarify before we are done up here. Owen? >> As a clarification-- are we waiting for clarification? (inaudible) I'm not sure what it means to be in the preamble or not, but the guidelines I think are very solid and if we were in fact-- if the research community was required to fulfill that standard we would be in fantastic shape from a language understanding perspective. hopefully that's -- >> You can recommend that, put it in. >> I would recommend that. >> So Owen's recommending that we perhaps modify this recommendation to say that the regulation should make it a requirement to follow the plain writing act of 2010, I guess having not looked at it, my question would be whether from a regulatory point of view what would it take for IRBs to enforce that, would they expect to be-- be expected to be experts on the plain writing act and . >> Yes, I won't-- I won't express to be an expert on the act. I've read, you know, good parts of the guidelines, and they were long, 117 pages, but they are actually surprisingly written very plainly. >> Hopefully in plain language. >> Yes. so it would not be difficult to get up to speed at least in respect to the guidelines for most IRBs I would imagine. >> Okay. >> I need to understand more about the plain writing act. is that-- my assumption is that that applies to federal writings and they need to be consistent with that, heretofore to my knowledge it has not applied to non-federal situations, is that correct? >> That's my understanding. >> It would be a fairly dramatic requirement, wouldn't it, to bring the informed consent language under this given the technical nature of many biomedical interventions, to what extent is that a feasible approach? >> I found the place in the preamble that discusses it, and it says the comment-- because commenters agree informed consent forms should be written in appropriate language ... language understandable to the subject ... this goal is consistent with federal plain language guidelines and federal plain writing act of 2010, the secretary will public guidance at a later time to explain how consent forms can be written in order to comply with the requirements of this policy. so it is not envisioned that the regulations would require a formal assessment to evaluate-- oh, that's competency. anyway, it seems like the preamble already addresses what we're proposing. >> And that seems clear that guidance that HHS will public later will help be consistent with the NPRm policy, not necessarily with this law, so the guidance won't bring into compliance with the law itself. >> I think the preamble as to specific what they meaning by "policy" because it could be interpreted as policies expressed in the law. >> Let me express my caution about overreach here, and not necessarily saying we-- I don't know what it means to sort of make consent forms consistently consistent with this federal plain writing act. it sounds like a good goal but I'm nervous saying that ought to be a short-term accomplishment. >> Yeah, I respect the unreadiness and I'm fine with that. I think we've long talked about a standard, and a goal, and, you know, this is I think a great move in that direction. >> I don't think any of us are going to say written consent forms are a bad idea. I worry about IRB mission creep depending on how you read that. I don't know if it helps but here we talk about what's described in the NPR M or changes to informed consent, by the third photograph we say we support the proposal so if there's a way to make clear that the section on the federal plain language isn't necessarily written as a proposed change to the regulations, maybe taking it out is the simplest way, I want to make sure we don't appear to be recommending that it become part of the regulation if we're not comfortable with that. >> Maybe we should say-- add to the SACHRP support second sentence, SACHRP supports a goal of informed consent language that's generally consistent with the standard articulated in the federal plain language guidelines. >> While you're typing let me express my understanding of what this background section in the proposed informed consent language would potentially do. I think one of the challenges we've had over the last few years trying to focus on informed consent is language that gives Ohrp a hook in requiring language to be truly understandable to the potential participant population. my understanding of the goal of some of this background language is express the goal, provide regulatory language give Ohrp greater leverage until really saying what is acceptable and what is unacceptable in the informed consent form and process. let me lay that out there and see whether Gerry agrees with that interpretation of what this new language will do for the research community. >> I fully agree with that. I think I mean we end up having lengthy discussions over years about how can we get consent forms shorter to the point in clear language giving the person in a concise way the key information but in detail to make decisions they have to make and the current rules from our viewpoint and I think from the viewpoint of many others do not have enough regulatory teeth to say we could do something to say it inappropriate to have 30 or 40 page form where it's in the footnote on page 17 or something, but it was key information that you need. so I think the goal is totally consistent and we fully recognize obviously there will have to be guidance, hopefully guidance that will be relatively specific in terms of giving examples of good consent forms that people will actually know what should or should not be in the main consent form versus the appendix so people will have a fairly good understanding of how to move forward. that's the goal. >> Let me add one brief editorial comment. I think that from my perspective at least there have been lots of good examples, lots of good work to say what better informed consent looks like in terms of forms and processes. a lot of that has had limited impact so I think eventually it's going to take Ohrp saying this is unsatisfactory so I think that's leverage beyond offering good examples. it's leverage to say what's acceptable and what isn't. and so hopefully this is a direction that will empower Ohrp to make those determinations. >> Absolutely. I totally agree. the point is that the new language basically gives us the authority to say this is acceptable and going-- and bad examples too saying these things are not acceptable, it's like in the first two or three pages you have to lay out this stuff such that you don't need 15-page grid of all these side effects or whatever it is, all you need to do in the core part is a couple paragraphs, for example summaries of what's going to happen, how sick you'll be. clearly yes the goal is to say that by implementing these regulations a lot of the not that good consent forms will no longer be acceptable. we cannot accomplish that and be back where we are now. a lot of us agree it's not the best situation. >> All right. so maybe -- >> Thank you. >> Jeff and others, maybe this works, SACHRP supports a goal consistent with the language in the federal plain language guidelines and the separation of information into a consent form that's limited to the information required at section 116 and appendix, SACHRP recommends Ohrp develop guidance and implementation of appendix, et cetera, does that satisfy folks? Okay. excellent. we move to the elements of consent. and here I don't think we had many substantive changes from the last time that we saw this. it was fairly straightforward in our previous review. new basic element at 116 now a 9 which would talk about the use of-- downstream use of data with or without identifiers. we had again really not any recommended changes to that section. and then additional elements of consent at 116b, this would add 7, 8 and 9, the text highlighted in gray, based on our last meeting we've got a few proposed changes that I've got highlighted here so in 116b7 we added for the development of and replaced profit with products and whether or not sharing in revenue from and we wrote the commercial product. that was one change. number 8, the committee wanted to delete the words clinically relevant and make it more broad to say that subjects be informed of whether research results including individual research results will be disclosed to subjects and if so under what conditions. and then one of the pieces that we struggled with in our last thing, I'm going to scroll back up, number 9, which would provide subjects legally authorized representatives with option to consent or refuse to consent to investigators recontacts subject to seek additional information or biospecimens or to discussion participation in another research study. we deliberated trying to find out if this was an actual problem, what were we trying to solve by adding this and whether it added value, ultimately we recommended deletion of that element saying it was unnecessary and could create unnecessary burden implementation challenges for researchers. Since that time as draft has been circulated I think a couple people made a point which is that if we did not include this in the elements, even as alternative element, then under the new mechanism where we would split concept forms into the main body of consent with 116 language and information in appendix if this information wasn't one of those elements it might fall off the radar and not be-- may not make it to be included in the main consent form and could be lost or buried in the appendix. there's possibly a couple ways of solving that. one we don't have in here but we meant to add and didn't was the notion that another part of the regulations allow the IRB to decide if additional information is required to be in the main body of the consent. I know we talked about that last time but I don't know that it made it into a recommendation. that's one way. another way would be to look back at that section 9 language and take another run at trying to improve it. >> Pilar, did you have -- >> So I had a question about that little throwaway line that you just had which is you said another section of the regulation allows IRB to require that additional information be in the main body of the consent, it actually doesn't say that in the regulatory language. it says that the IRB may require that information in addition to that mention in 116 be given to subjects, blah, blah, blah, and so this was actually one of my questions is later on so it just said IRB can require additional information but seems as though if it does, that that additional information is important enough that it should be in the main body of the consent and not in an appendix and yet when you look at 116 it says that information-- that the information required by this section which I was assuming was the information in the basic elements of 116 is what is required. so is what should go in the main body of the consent. so my question was shouldn't that be broadened or somehow shouldn't the regulatory language make clear that if under 109 the IRB thinks there's some additional thing that the participant should know, that that also could be in the main body of the consent and not in the appendix. >> I think when we talked about-- when we talked at the last meeting about the-- about the ability of the IRB to insist certain additional language go into the consent form we were clear that was the main consent form and not the appendix. whether we need to say that as a recommendation that it be clear that that particular language be altered to say into the main consent form might be worth considering because we don't say that now. that's a discrete thing we could deal with as a group and decide if we think that needs to be said. and then specifically for the information in this proposed B9 we could for instance consider changing the language so that it's a little more parallel to number 8, whether or not the investigator plans to recontact them in the future, I don't know if that helps tremendously but it's-- Jonathan? >> I want to just say I think we should-- I actually like what you've got now. I don't think it should be a required element. I think it has more potential to confuse participants than help participants because I think as we talked about last time if they say no to this, or they say no to every investigator in the institution, which I think is what a lot of people think, so then when they get called by a different investigator from the same institution or the system they think I already opted out, why are you calling me? You opted out for Dr. Green's study, not from being contact the for everybody else's study. I think, you know, unless it was-- if they opt out on one study it means they are opting out for everything but somehow that's going to have to be, you know, disseminated to every investigator in the institution or multiple institutions. I think it's practically going to work out to be more of a problem than a fix >> I just have to say that in genomics research people are doing this all the time because they have this idea that, well, you're in this study, but we might find something that would make you eligible for our, you know, next study or for Dr. Such and such next door's next study and so there are a lot of consent forms that have that, would you agree to be recontacted or not, and I haven't heard of it causing a lot of problems >> we take it out because of this problem. they opt out of my study, but it's not a related study, they get contacted by somebody completely different department doing something else and they are like, no. >> I have an even more basic question. I remember some of the challenges we thought could happen if it was implemented but couldn't remember the basic problem it was trying to solve. >> I think the basic problem that it was trying to solve is that in a different scenario than the one Jonathan described you have investigators that call the IRB office and say we really would love to get back to Mr.Garrett, he was in one of our studies, we need something, additional information or whatever. and an IRB may say what did you say in the consent form? Did you leave this opportunity for recontact open or shut the door? If they just shut the door we say, well, you promised you wouldn't do that. here part of what it may solve is getting P.I.s to think of people writing consent forms to think about that and say there's probably a good chance we'll want to call him back because, you know, he's a great subject, or we plan to do a series of studies in this area and so this way it would be very clear in the consent form the subject is aware that might happen and has a chance to say no. I think at some institutions they do prospectively ask people to check a box or separately endorse something, as Jonathan said other institutions for other reasons that might cause confusion depends on how it's implemented or how it works in practice, but that's the other side of it is investigators that want to go back to somebody but haven't put that potential in the consent form itself. >> It's a presumption you won't be able to go back, right? There's no prohibition to recontacting, except if you say you never will. if you're silent on it, they signed up for one of your studies, why wouldn't they be interested in another one? And if they were a terrible participant or complained you wouldn't want to. >> Right. >> Is it studies where you're anticipating this is a possibility it seems to me ethically appropriate approach is to tell folks as part of the informed consent process it's possible we may need to recontact you and for whatever reason people don't like that idea then don't participate in the study. I do think the other element with the option language is the tracking issue, which then can become-- well, it's not substantial if you have only a couple people but can be substantial otherwise. I'm of mixed opinion whether the issue of allowing flexibility about what the IRB wants in the consent form, this exception could blow out of the water the larger structure here which is to say we're trying to shorten consent form by getting extraneous stuff out of them. I don't know whether the length of the consent forms is due to length of required elements like the risk section or to what extent it's extraneous, but if we say it could be added does it eliminate the purpose of this NPRm proposal? >> Stephen? >> Yeah, I'm sympathetic to Jeff's argument that the IRB, I brought that up last time, and I think Jerry reassured us whether it was clear or not the intent was not to forbid the IRB from putting what it felt was necessary in the consent. but the basic and additional elements are really pretty comprehensive. it's hard to imagine the IRB wanting to add something that didn't fall into risk, voluntariness, all the things in the element. I can see the IRB adding risk discussion but it's hard to see the IRB feeling it essential to add something that's not in any-- wouldn't be covered in any of those required or optional elements. I'm not sure what we get by putting that guidance. >> Pilar? >> What I think I said last time you could have the IRB include information as to whether going back it pilar's point it necessarily had to be in the main consent form as opposed to appendix. I think I was not saying that other provision gave the authority to say this has to be in the main part of the consent form, and I would think current reading certainly doesn't make that clear and I think it's an appropriate policy outcome for the reasons Jeff and yourself said. it's a fairly obscure provision that I don't think currently many IRBs spend a lot of time with. Ohrp we don't hear a lot about it and therefore having it sudden become this major lead thing that could cause consent forms to not change at all because IRBs, certain IRBs say we love having this information in these core part of the consent form and not appendix would be problematic. the best way to deal with this, my viewpoint, we would come out with guidance and hopefully say when stuff could or not not be in the pain part of the consent form. it's a fair reading of the authority under the current provision and I actually think that would be a fairly reasonable way to deal with it as opposed to saying anything the IRB put under that other provision would have to be in the core part, if the IRB said it wanted it. >> I wanted to go back to the point of why might you feel like you had to put something in about recontact so I think one of the reasons this is coming up in genomics research is because sometimes you recontact people for the second study based on something you find or you might want to do this, based on something that you find in their genome in the first study, and investigators want to signal something about that to the participants so that they don't feel blind sided when you come to them and say, oh, we found something in your genome that's interesting to us, and so I think in that context people have felt that it is helpful to do that, and I mean if the opportunity to recontact is in the additional elements, it presumably means if an IRB really felt the way it was written or just felt that they don't like that, it wouldn't necessarily have to include that, but, you know, investigators and IRBs who feel strongly they want that could include that in the main body. >> How about this. let's respect that. I guess I'm also worried, maybe this picks up on Jonathan's comment to some extent too, that you may have counter examples where somebody said don't bother me but you find something you might think is something folks would really want to know, or may benefit them. so I think where my proposal is going here is to say-- potentially limit the option element of the optional element. in other words, the additional piece for the consent form would speak to the question about recontact, rather than necessarily offering the option not to be recontacted. if they want to give people an option that's fine but if they want to include something that says we may recontact you in the future, and folks don't like that then they don't participate in the research sort of element. speak to the issue as an optional element but not include it as an option not to be recontacted is where I'm trying to go with this rambling comment. >> Are you saying that people would not be able to make it an option or that we're not going to-- wouldn't be able to opt out of being recontacted because specifically recontact for future research which doesn't exclude recontacting you in the instance we find something we think you really want to know in this research. >> That may be confusing for IRBs to sort through that so I'm suggesting the IRB wants to put an option, the investigator wants to put an option to say don't recontact me that's fine but if the investigator wants to put in we may want to recontact you and we might do so, and not give an option or simply say we never were going to recontact you and we promise, then that would be acceptable too. so the optional element would be to address recontact issue as opposed to necessarily offering an option. >> So does that mean put it back but edit it? When appropriate elements of the -- >> It is. >> Okay. >> Just to clarify I think I wasn't thinking about this until you mentioned this, pilar. this is completely distinct from the idea of results procuring. >> And there's another provision in here about results return. >> Number 7, yeah, the-- number 8 is the return of results. I've pasted number 9 back in here. >> I would edit to say-- would provide subjects or legally authorized representatives information about whether investigators will recontact the subjects to seek additional information of biospecimens or -- >> I wouldn't say to seek additional information biospecimens but for future research, right? Isn't that -- if you want to seek additional biospecimens you would put that in, right? >> Yeah, I think that probably makes sense. >> Last time we discussed this, at many meetings, I want to raise an issue that came up with respect to this. Jerry might have something to add. if you say here a an option to be recontacted and in the body you say if we find something actionable we may contact you anyway, the question arose whether if you have this, can you still have in the body of the consent essentially an override? >> There are two different things. one is recontacting people about information discovered in the current protocol, which it speaks to in optional information, whatever, I can't remember which one, the second one is recontacting you for participation to invite you to participate in a future protocol. here is what goes on at data farmers. there's a front door consent cancer VACCINE study and let's say you have people who come in and say, yeah, sure, you can take my specimens, connect it to my medical information. and it does have a request, can we recontact you for further research, but we might if we find something actionable, contact you anyway. let's assume that down the road people who are doing research on the specimens find there's a mutation for pancreatic cancer and let's assume that there isn't one that exists, and so they go back and they look and find five people who participated in the study who have the mutation, and four of those said yes recontact me, one said no. the question is today we would say the consent said if we find something actionable we'll contact you anyway. could that still happen? >> Right. and so here putting together some of these thoughts is that that sort of recontact is covered in number 8 that we're going to recontact you with results-driven things or other information related to that kind of study information. number 9 would be the other recontact, it's a matter of whether you leave it brought and open ended and say recontact for other purposes. >> I do think that -- so the example you gave is good example of partly why people put in those kinds of provisions, when they are asking people to give samples for banking, is because there are some protocols, many protocols, that we all might think if somebody puts in their sample for banking it's going to be unobjectionable. but then there are going to be other protocols maybe based on what you find in those studies on bank samples where you have to get consent, interact with participant or even if you don't have to get more specimens it's something that is too sensitive to do without people's consent and then like put the data in the dbGAP, that's the situation where it's good to have that as an option and let people-- because what it does is it puts a barrier between the kind of run of the mill studies being done with banked samples and other studies more complicated or potentially more troublesome to people. and for those studies we're going to recontact you and get additional informed consent for that study. >> So here I put back a different slightly modified number 9, assuming 8 covers the things that Michelle was discussing in terms of compelled to contact you because of this result we've observed, number 9 would be broadly, you know, information about whether investigators will recontact the subject for other purposes and examples that were taken from the original language, seek additional information, or to discuss participation in other research study. it's brought. it my tie it up. these really are, again, reminder of elements, this is not something that is going to be required to be in every form. >> What would be the other purposes, besides participation in another study? >> Other purposes not already covered in these eight? >> To find out research experience, what encouraged them to enroll. >> But that's another study, what would be not another study. >> Satisfaction set of questions might not be another study, maybe that's part of the original study, in which case you wouldn't need that I suppose. >> We've seen instances where we get requests whether it's acceptable to recontact under the original consent for additional laboratory tests if you come up with a trend and want to make sure these people do or don't have it or want to embellish secondary endpoints but it's otherwise closed and finished. >> To the point Michelle was raising earlier, I think probably I have a different interpretation, David as going 8 is about-- I would assume 8 is in general there because often you want to say we're not going to give you results, maybe the genome sequencing for example we're not assuming obligation to give you results, assuming a study didn't have any provision relating to that I would hope it would always be the case that if researcher would learn something that's important to the health of the person regardless of whether the consent form said anything about giving you results, even if it had a provision under 9 saying we're not going to recontact you basic ethics I hope reasonable interpretation would rule would always mean you could get back to the person and at least ask them, we found out something we think is important to your health, we would like to tell you about it. >> Sort of, yes. >> That's what 8 is about, 8 was not overpromising, people would not be in a research study if you want to do whole genome sequencing, you have the data and refuse to let me have access to the file that I can discuss with my own physician, that's a big consent issue whether somebody wants to be in the study. it shouldn't be viewed as something preventing researcher from going back and telling somebody important results that's relevant to the person's health just because you didn't put in a provision 8 there, it's a different issue. I think what Michelle was getting most researchers if you find something important to somebody's health nothing in the consent form should be a barrier, an appropriate circumstance trying to recontact and view what's reasonable, sort of a rule of rescue, yes. >> I appreciate that. I still think you could read that both ways that you would include the things you would recontact or take back the things you wouldn't. >> Let's assume you had nothing in that, then it sound like you're saying you can't recontact, and I'm saying no, if it's an issue about some important relevance to a person's health. >> It overrides. >> Yes, not viewed assaying I didn't say it in it the consent form and now there's the curable disease. >> Here is where I have my layperson disconnect. thinking through the whole system here, starting with the notice and opt out, and I come in and get my notice, I agree, and then I assume I'm getting this kind of informed consent, for all the research studies being done. >> For all the ones you gave notice, if you gave notice and opt out there would be many studies done with your specimens without this full consent, right? In fact probably most would be done without your full consent so this is when you're coming in to participate in a study. >> If I opt-- we don't have an opt in but I agree to that, those things are done, I don't want to be contacted. it's basically saying, you know, take my data, take my biospecimens, do what you will. >> But there are going lots of studies when somebody would have to recruit you into the study because it would involve a lot of things other than existing specimens that are already there or existing data, right, where they might want to recruit you to be part of an explicitly prospectively organized study. >> I get my notice, I opt out, I don't want any part of this system but say I'm very interested in participating in cancer research specifically, right, that's where I come in with this informed consent, include me in your cancer studies, contact me in the future, this is an area I really want to contribute to, I think somewhere along the line there's got to be a way for people to say, here, do what your obligating me to do through the new system but I don't want to be contacted. >> I think, Diana, you're conflating the consent with the notice. these provisions are just for consent for research that you're actively enrolled in and that's going to intervene or collect identifiable information in the context of that project, maybe what you're saying is in the context of the notice an opt out for secondary research maybe we not some other provision in there about future contact or result return or something. >> Exactly. I'm not sure if that's conflating necessarily. >> The reason I said conflating is this one is about consent, and the other piece is about notice. we didn't get into all of the elements of what the notice would look like, so maybe . >> I heard Diana differently, she was tieing together some of Jerry's comments we would have an obligation to contact if we learned something but if I had gone in and not opted out and then they were using my sample also left over for me to figure out new assay work now they can test for X would they have an obligation to hunt me down and say guess what? >> I think we need to really be clear that whatever-- however 8 cuts, it's about giving people information that somebody argues they might actually need and 9 is about getting recontact because investigators want more stuff from you, one way or the other. >> Right. >> We can't forget that being recontacted is not the same as being dragooned into another research study or being made to give up more stuff. the idea of recontact is if you call somebody up and say they don't contact me and slam down the phone, that's fine. you got your answer. so part of this is distinguishing recontact from what happens after the recontact, you always have the chance to say no. >> I'm afraid we're overloading these a little bit. I think -- taking out the clinical relevant language, maybe I'm missing this but I don't think any of this, to Jerry's point, was meant to be for actionable importantly actionable clinically relevant information. as Jerry pointed out you have some obligation, CLIA issues aside, PERHAPS, you have some obligation to act on that if you have incidental findings that are important to someone's health, I think 8 clarifies-- so people understand what to expect, and 9 is sort of for future contact, they are different things. >> I agree and I think the reason to have them in here as optional elements is because for instance recontacting about returning individual results, if you have a plan to do that, then you want to let people know that you have a plan or if you have a plan not to give them as a routine matter, individual research results, that's something many people might want to know when they are deciding whether or not to participate. so I think that kind of stuff should be able to be in the main body of the consent and so it should definitely-- it would have to be enumerated in it's in the main body of the consent, right? >> Could I throw out another point? If I get a-- genetic test and a variant of unknown significance is my result and three years from now a lot is known about that, is that number 8, being given updated research result or is that under 9 where I'm being recontacted because the field change, there's new information, et cetera? >> We want to keep it clean, number 9 is simply about recontact for future studies outside of that and, you know, I don't think we can get into the complexities of how you return results. >> These are real world scenarios. >> Exactly. I think 8 is addressing, you know, some part, we'll give you incidental findings, another part to the proposed regulation if there are to be return of results there has to be a plan that's going to be reviewed by the IRB. that's where that will get hashed out. >> So one of my major areas of bioethical research is on the duty to recontact, and it's quite fuzzy. and the American college of medical genetics, among other professional societies, has a task force that's reviewing previous guidance on this matter that was published in 1999. there will be more to come. I don't think it belongs here. >> Well, but I agree that a lot detail doesn't belong here but suppose Acmg says in some research context there is a duty to recontact, and nothing about that is optionally in the guidelines, then you wouldn't be able to include that in the body of the consent. so partly I think we ought to keep this pretty general because people-- we ought to put them both in. people are still working this out and it may be that, you know, Jonathan's point of recon fact for future studies that institutions find it too difficult to have wording that will be helpful and not problematic and they are not going to let people put it in. but if it's not enumerated here we don't have the opportunity to do that experiment. >> I wanted to reiterate that. I think these are doing different work here than they are doing in the current regulations which are telling you what should be in the consent. if it's not on this list, it can't be in the consent. it's in the appendix. I think that there's an attempt here to put things in that may be important under particular circumstances and that you want to leave a place for and the authority to put into something that someone sees up front and signs. it's not like we used to talk about elements of consent about what's important. what is in the consent. >> Okay. my sense of the conversation is that we're still coming back to pretty much where we currently are. other than potentially Diana's comment about what I see as a separate issue about whether say patients in a health care facility ought to be offered option of not being contacted at all for research purposes, which is different than what we talked about with respect to opting out of access to biospecimens and data, and that's an important consideration but given the fact it's not part of the NPRm I'm not sure whether it fits within this current regime. but we can talk about that some more. I think what I'm hearing us saying is that we want option-- information about the recontact of people for research results to be in an optional element of the consent form, without dictating what that decision is, and then I think, you know, depending on -- >> That's number 8 >> Number 8. number 9 is the proposal still on the table to say remove that as a required optional element, and just require the additional element that might go in the consent form which speak to the question about whether or not participants might be recontacted in the future, if investigators want to offer an option not to be contacted they can but wouldn't necessarily be required to offer that option. >> So then the question might be if everybody is in agreement with that then does this language capture what we want to say there. >> So the section would provide subjects with or legally authorized representative information about whether investigators will recontact subject for other purposes, and maybe that's might recontact the subject. >> Yeah, I would change to might. >> to seek additional information or discuss participation of the research study with an option to consent or refuse to recontacting the subject to seek additional-- there's redundancy. >> They didn't delete that part after the parenthetical because we hadn't decided to discard it yet. that's what I read that as. if we take that out then we've got the thing that we've been discussing. >> Yes. >> So we want to include in here the phrase to say or offer option to not be recontacted. so it's whether or not they right be recontacted or offer option not to be recontacted. there needs to be an "or" after the parenthetical. >> Yeah, I would say. >> Does this flow now? >> The other purposes, there was some question about whether that's the right language, and does that mean extra study purposes? Well, it might not mean extra study, maybe a continuation of the existing study that you're recontacting them for. maybe other purposes. >> I think seeking additional information is broad. it doesn't quite flow. >> No, it should say "or offer an option not to be recontacted" or something like that. >> Okay. are we good with this one at the present time. >> Why not say offer option to refuse recontact? >> Yes, I agree. >> Okay. so I think that eliminates this next paragraph, since all this falls under the following modification of the proposed language. are we set to go on? Is that good? Great. okay. >> Now we'll switch gears and move from consent, move from the information in the consent to the posting of consent forms and this has been revised to reflect your position that this should be retained in the final rule, you recall the subcommittees did not endorse the recommendation but revised this to reflect that it be done, so we continue to support greater transparency and then we've got in general SACHRP endorses requirement for posting consent forms but recommends Ohrp develop guidance to minimize confusion about imelementation of the rule, reduce risk posted consent forms will be misunderstood or misused and maximize ability of investigators, institutions and regulators to review to improve the process in multi-site studies necessary to ensure requirements are met, SACHRP recommends IRBs not be responsible for enforcement and HHS use clinicaltrials.gov as the repository so they can be easily linked to relevant information about the research. >> This is clearly an attempt to compromise the two positions where the main committee was supportive of transparency, I like that idea, the subcommittees originally opposed the idea but based on a number of concerns so what this does is basically express the general support for the posting but then brings in the subcommittee's concerns in a way to suggest guidance, try to minimize those concerns. >> I don't want to-- sorry. go ahead. >> I was very supportive of the idea of posting on clinicaltrials.gov because it's there already. as I thought more about it, I had some concerns, that's where you go to look for trial information, and these should absolutely not - it's the first version of the consent, you can have years of amendments that won't be reflected. you don't want people looking at the consent as a lay version of what's going on in the protocol like clinicaltrials.gov is meant to be a public resource and so either some language will need to be added at the time of posting if we use that source, it does change the purpose of clinicaltrials.gov, the purpose of posting the consent is not to provide information about the study, but to provide information about consents, and we should just do something structural to make sure that's clear or not us or guidance or something. >> What was the advantage, proposed advantage of being on clinicaltrials.gov? It's a preexisting resource that folks with familiar with? >> Even trials themselves are amended all the time and it doesn't change, the basic information on clinicaltrials.gov. I mean, I understand your concern for the confusion but, you know, I don't think you have to assume it's going to be misunderstood. >> Fit impacts the stuff that's list the on clinicaltrials.gov, it's supposed to be amended. we have IRB members who just find the consent a much easier version of the study to understand than the protocol and they will often go to that first and I think with the way we're doing this which I'm fine with that's not the purpose and I think it is potentially misleading and will provide people with data that simply is wrong, if that's the purpose of the-- perceived purpose of the clinicaltrials.gov listing of a consent because the intent of this is transparency in writing consent, it's not to provide study data to people interested in participating. >> I agree with that very last point because it's not supposed to be posted until enrollment is completed. I think the reasons we suggest clinicaltrials.gov are two-fold, it's an existing structure and the pieces are there, and so you wouldn't have sort of I won't say competing websites but another thing to go into and look for these things. I do think there's a little bit of-- I don't know that I completely agree that simply putting them in two places woman keep people from-- from linking this is the study I was in. >> There may be compelling reasons that's the play-- place to put it but it should be clear what it is and what it can be used for. >> I think unintended consequences of posting will be litigation. I think this is going to-- the main consumers may be trial lawyers of this. I'm not sure that the transparency will be effective in improving consent. we don't know until we try but that's predictable outcome. >> I disagree. because the people who might want to sue already would be the subjects in the study, they already have access to the forms. I think this is going to be a valuable resource for people who want to do research on consent and potentially developing new methods of consent or thoughts to make consent clearer. I'm optimistic about this. I don't think it's going to create vast amounts of litigation and, again, people who might litigate already have access. >> I totally agree with that. to the extent there are lawyers going around looking to sue institutions for problems in research, I mean, I know of one, and that person when he hears about research he thinks it's problematic, he can always find participants who have their consent forms. and frankly I don't think there are very many lawyers running around looking to do this because they lose often time, right? And so it's just not really that appealing. >> There's a cost in losing so I wouldn't minimize that, but -- >> But they don't even want to start. >> no, cost to us. let's recognize the vast majority of consent forms aren't related to clinical trials. putting them on this website is somewhat misleading I think, and I hesitate to increase federal administrative burden but maybe we need a consent.Gov as a rear to. >> NPRm limits to clinical trials so it wouldn't be capturing many studies, as written it's limited to clinical trials. >> I'm hearing more studies not clinical trials making it on to clinicaltrials.gov because of the new requirement to be on there to publish. >> Jerry? >> Well, there's lots and lots of trials that are not clinical trials on clinicaltrials.gov but, again, this requirement is not imposing obligation on anything other than a clinical trial and I want to back up the point others made about the amount of litigation in the field. it's it's quite surprising how little litigation there is in this field, given how litigious people are in this country, there is, you know, there are few lawyers who will take these cases and this is probably because it's really hard up to now to win them and just because there are consent forms out there anybody who has read this week's New Yorker or whatever it is, it's like every time you hear about it it's like it's hard to get anybody to take a case even if horrible things happen to somebody. so there is far more talk about all these lawsuits that are brought when the reality, when you look at the evidence, there are very few lawsuits in this area. likelihood having some consents out there, energizing all these lawyers to want to spend time bringing cases that they are probably going to lose is very little evidence suggesting it's a real problem. >> Jerry, I think it's a mistake to exclude the value of posting it. the benefit to patients. if we have an overarching goal to increase health literacy, to increase research literacy, people get noticed. they find out about the research process. there would be benefits to patients seeing these things, whether or not it's-- I'm not talking about patients in the trial, but having access to these consents would everyone, not specific to the research community. >> Our goal is to make this public for everybody who wants to see them. we're talking about posting them to a publicly available website. I fully agree. that's a good thing, sure. >> I have a language suggestion and it goes to some of the concerns that we have about making sure that things are-- making sure consent forms are regarded properly, I delete the last sentence because the goal is not to link to the other information about a trial so maybe it's just that we recommend that we use clinicaltrials.gov because that's a good place to put them, period. >> Like that? >> Yeah. >> So a couple quick thoughts. I'm not entirely-- it sound like there's not a lot of frivolous litigation here, some anxiety about litigation may not be a bad thing here because it's the point of some of the transparency is to make folks act in ways consistent with standard of care. the other more specific suggestion is whether-- I'm not sure at least personally whether trials, clinicaltrials.gov, is the place to go. we want to say SACHRP recommends HHS consider clinicaltrials.gov rather than have made a determination that's the right place? >> I think that's good. >> Does this want to go around the table at this point? >> Okay. all right. and now we'll move away from informed consent and one of the areas that we've not talked about before has to do with the proposed changes to continuing review practices, still within section 109 of the common rule, and in the NPRm they propose eliminating continuing review for many minimal risk studies, they specifically call out studies that qualify for expedited review unless the reviewer documents why they think there needs to be a continuing review under this current approach to a full continuing review. and they also say studies reviewed by a convened IRB continuing review would not be required unless specifically mandated by the IRB after the study reaches the stage where it involves one or both the following, analyzing data or accessing follow-up clinical data from procedures subjects undergo as part of the standard care for their medical disease or condition so essentially some continuing review, current expedited categories would get swept up and would not be required for research involving secondary research use, in order to qualify for exemption and we've talked, this may be affected by the other parts we talked about. in short traditional continuing review would be eliminated, and they would have to justify the use for doing that and for studies initially reviewed by convened IRB so this is repetitive from above. sorry about that. however I'm at this last sentence, however the NPRm proposed investigators be required to provide annual confirmation to IRB that such research is ongoing and changes have been made that would require the IRB to conduct continuing review. we've taken a position, at the subcommittee level I'll be interested in your comments. we got bold recommending elimination of continuing review for all minimal risk research, by definition the probability is not greater in and of themselves than those encountered in daily life, if the IRB determines that the risks are so low as to be commensurate with daily life the value of a continuing review as mechanicism is limited, investigators should still be required to notify the IRB of any changes to approved research, of any unanticipated problems related to the implementation of research and when research is complete so we say SACHRP does not support the annual confirmation requirement which would reduce the net impact on administrative burden to the point where it is essentially unchanged, SACHRP recommends Ohrp develop guidance to address oversight not subject to continuing review such guidance should address oversight by the IRBs with consideration regarding mechanism and frequency of oversight activities. Owen? >> I don't have a super strong reaction, but I generally favored the yearly check-in as it was described for a variety of reasons but I think it does reduce some burden than the usual continuing review process and at least the way it was described seems as painless as possible. but probably more importantly I think I would not recommend to Ohrp to develop comprehensive guidance because I don't imagine guidance comes back any simpler than sending an e-mail, check yes and I send it back. we run the risk of comprehensive guidance, it just sounds-- it's going to be a more complex and comprehensive than the annual e-mail. >> I had a question about the intent of the check-in. so just because it's minimal risk research perhaps expedited doesn't mean there's not obligation to submit amendments. if people are fulfilling their obligations which are -- if they don't fulfill these you would have a calendar check on the annual notice but the IRB would have ample opportunity to assess whether the research had changed and was no longer minimal risk, I'm not sure what you add by the yearly attestation except as a sweeper to make sure everybody submitted their amendment or there was compliance I guess. >> So I actually feel like Owen did. when I do continue review I do it personally very carefully, right? And then you find all kinds of things. all kinds of things. right? But I happen to know as far as I can tell most people don't do it really carefully. and I think that this idea of having an annual check-in as a reminder to investigators where they go, oh, yeah, I guess we did alter that consent form and forget to file, you know, a modification are our IRB, all kinds of things like that I find get caught when you do a continuing review so if you just have even a reminder to investigators, and it might just be, you know, did you change anything in your protocol, yes or no, and if no that's it. >> But couldn't you-- what you just described to be an outbound communication from the IRB once a year to say you've got this study, remember your obligation to report to the IRB any changes and approved research et cetera. I think from the subcommittee point of view we look at the requirement saying we're getting rid of continuing review for ex-expedited review studies but they are going to come in once a year, you are not changing a whole lot. it's no longer maybe going through an expedited renewal but someone has to look at it, track it, you'll get minimal information about what's going on so we're not quite sure, and if the premise is it's minimal risk what are we accomplishing? >> Maybe we could address this by being sort of a little less vague in the last paragraph because I think what we're talking about is an annual check-in requirement, it might be one way to do it but it might also be a greater interval, it might be the IRB sending out a reminder e-mail instead of the other way around, and so what we want to do is figure out ways of allowing IRBs to be more flexible depending on the particular nature of what's going on, but still have a way to do some kind of a check-in that would allow for the possibility that weird things come up. >> I don't know if anybody at the table is at an institution part of the federal demonstration project but they have taken studies outside the common rule and given multi-year approvals or put mechanisms in place to deal with that and I don't know that it's led to problems in the implementation. Jerry? >> A lot of what you were saying I guess isn't all that different in terms of your alternative to what you were proposing, the first sentence of the last paragraph that this is reducing that impact, what was contemplated, and a lot of this as pilar was saying earlier, a lot of people who ran human subject protection programs saying if you did this a lot of studies would drop off the radar screen, low levels studies that a student is doing and you never learned if the study ended and this screws up the record with lots of studies on your back. what we said in the preamble it would be acceptable, again, similar just to notice you send out the notice, it says please confirm your study is ongoing and has not changed, all you have to do is respond with a yes, type yes. you could type Y and hit a respond e-mail. that's more minimal than what researchers go through with five-page forms in which they have to put an enormous amount of information and we clearly said exactly what I described would be totally acceptable but forcing the person to actually respond so they are confirming that yes the study is ongoing and yes by responding they are acknowledging I have not changed the study in any way, I had a report on the IRB side it's a good thing and will sweep up something about figure out pilar's point, I ended this study and forgot to tell you, to get it off the book, whatever it is. a lot of us didn't see much of an administrative burden, you say net impact is unchanged, actually a lot of us think, and you're in a better position to comment on what's required in terms of continuing review knew, but it's not that trivial at most institutions I think. there's quite a bit of information. year in and year out you have to repeat filling out a form again. we're saying no, you don't have to do that. this could be a one-word e-mail response. >> There's also question in agreement with that, that institutions are going to want to do this whether or not the common rule requires it for exactly the administrative stuff. we've got to know when studies are closed. and so maybe the thrust of the last paragraph should be to say SACHRP recommends Ohrp issue guidance to somehow make sure that the annual confirmation process is as administratively-- I'm not coming up with good words. easy. streamlined. perfect. an e-mail. >> In the preamble. >> We want you to say it again. >> Even if it's a one-word yes would be a mistake because so many investigators say I get automated e-mails from the dbGAP, from the IRB, I get so many automated e-mails that I just don't read them. and so you actually want to know that the person read it. >> Let's actually go back to the line 85. recommends elimination of continuing review for all minimal risk research, I think that's a bold statement so we'll move past that, make sure where folks are with respect to that recommendation. >> I did not hear much support. >> Oh. I didn't hear much complaint. >> My one thing just to raise, I don't know if it's a big issue or not in terms of things like compliance to recruitment goals that the IRB approves 100 participants and you recruit 120 because you thought that was a good idea, those are minor violations that I think you sometimes pick up on continuing review. because it's minimal risk do we not so much care about those things? >> annual confirmation requirement, then-- I presume that, again, the outbound communication would remind investigators what their obligations are to the IRB that, you know, should be sufficient. >> Is there broad agreement for this recommendation about minimal risk research? >> I'll voice support for it. >> Yeah, I'm seeing -- >> Okay, good. >> Do we have edits or clarifications with this? >> Yeah, I think reinforcement of need for amendments, changes, all that is still there. >> Going back to-- okay. never mind. >> SACHRP supports -- >> I couldn't sneak that past. >> Make that coherent with the rest of the paragraph. >> The annual confirmation requirement, that probably goes. however SACHRP recommends ... streamline annual confirmation ... okay. what else we got? >> That's it? Oh my goodness. we have to find something to talk about. we have to go back, I know. we're not completely done. all right. now did we adequately review-- one step back. what you've seen is a bunch of different documents from the subcommittees formatted in different ways so as we-- stitch these things together, we'll come up with a consistent formatting so the final document will have different formatting but should have the same content that you've seen. we want to highlight the recommendations in a way that folks who are skimming the document can pull those out in a readily available fashion. so are there other items that we need to discuss with the consent recommendations? >> Properly in the biospecimen. >> Oh, yes, we do want to pick up on that. let's not forget that before the day is over. so I think we are at a position now to vote on the informed consent recommendations as we have just reviewed them. >> Second. >> We're getting good. any other discussion? All in favor? Opposed? Abstentions? Great work. >> Does that include the continuing review, you mean the whole document as edited? >> Yes, the whole document, of course. >> Good. I will hit the "save" button. >> Thanks to you and the subcommittee. now we'll go back to exclusions and exemptions and see whether there's been any substantive changes in the language that we may need to revote on those given our enthusiasm earlier. >> Do you want a minute or two? >> If I can get rid of that -- >> We could do a quick Bio break. we're in good shape here. why don't we take ten minutes for a break and come back at 2:20. >> This will be quick, putting in the clarifications. the first thing I did was put this note up at the top of the exclusions and exemption saying SACHRP should consider the definition of intervention is consistent through out in the NPRm, that was pilar's point, including the proposed exclusions and exemptions. I put a note in the header to the exclusions that we have one of these, we didn't feel we had sufficient expertise and made a new section to list it in, that's noting it up here. here is what we moved, surveillance activities, now at the bottom we don't have the expertise to comment on this. I changed the minor and major proposed modifications because we have three to varying degrees, all with proposed modifications so I narrowed a bit with modifications, the first is B1 adding and quality. that's unchanged. the second is this B12, we made the changes to the oral history, et cetera, and then I added this one, this is the 101b14, wait, this is what we did before about the-- okay, I'm sorry. this is the quality improvement. here is what I wrote as the statement. I would like you to look careful and see if that's how you want it to read. >> Read that for us. >> SACHRP recommends this exclusion be modified to provide greater clarity regarding the times of activities that meet this exclusion due to concern proposed wording will be interpreted in too restrictive a fashion regarding collection of data that could lend itself to an evaluation of an accepted practice itself. we took out our recommendations on how to change and said please give us more detail about this. >> Could we put do and do not? My concern is things would end up in here that shouldn't. >> That would be meet and do not meet? >> Correct. right, right. >> Okay. >> Okay. >> Okay, good. >> All right. >> Took out all of that. and then this is where we put the exclusion 101b2-2, for non-research purposes, if publicly available or recorded by the investigator in such a manner, and what we said here was that SACHRP recommends this exclusion be limited to section A only when the sources are publicly available, SACHRP recommends B be moved to the exempt category for several reasons, believes classifying ... provides better conceptual clarity ... also believes exemption process will assist investigators in interpretation of the regulatory requirements. >> Great. moving on. >> I'm going to save this. okay. then we have exclusions that should not be adopted and here is where we moved-- here is the start of the language for the ones we didn't feel were appropriate under B2 because they were research and privacy didn't cover. this is the first one, B2-1, we said SACHRP recommends this class of research be moved to the exempt category for several reasons ... also notes in regard to laws and regulations providing privacy and confidential protection there may be issues involved beyond privacy and confidentiality concerns, believes the exemption process will assist investigators interpretation of the regulatory requirements. >> Okay, moving on. >> pretty similar. it's gone. it notes there may be other issues. what would get left off was the last sentence about assist investigators, no, yeah, I guess assisting the investigators. which we could add in. okay. okay as is? Do you want me to add the other? >> Yeah, I suppose adding it in for consistency. >> Okay. same thing with B4, B 2-4, HIPAA, several reasons, helps clarifying the distinction, notes laws and regulations ... such as potential for psychological distress, at least one reason. and then believes this will help the investigators. okay. then added a new section here, new heading, this is underlined, you can't tell. and here is where we put the surveys, interviews, et cetera, for authorized intelligence operations, authorized intelligence, and said we just don't have the expertise to provide commentary. I should note, I don't see Libby now, Libby asked whether we should put operations in there. she's not here. we'll take that back out. >> We had a little bit of discussion, about whether we wanted to promote more public, for this exclusion, do we want to add that to our statement? >> There's public concern, however you want to word that, about adding a sentence that says SACHRP requires additional public justification for this proposed exclusion. >> What kind of additional -- >> You know, additional. >> In other words, write more in the sort of preamble lead up to the proposed, to the final rule, when it's published, that's basically what's that's saying. >> Yeah, PERHAPS include reassurance about what it doesn't cover, not giving free rein description. >> Okay, good. then the exemptions. here I gave you a voice. I did note we created-- first I said we think they are fine, with limited comments, but I added in there is one we didn't feel we had-- we can say we have limited comments or we didn't feel like we have expertise, that's the one for the public benefits exemption. we can take this sentence out if you don't like where you put it. that we already did. we could put this-- notice the setting is the-- the heading is exemption acceptable as proposed in the NPRm, so we could put D2 here and just make a comment that SACHRP notes it supports the public posting, or I felt alternatively we could go to the bottom, say there are exemption which SACHRP has insufficient expertise to address, put the exact same thing and add this sentence 408, up to this commentary. >> I think I like it at the end better. more transparent about what we're-- whether we support the body of it or not. >> Okay. we still have the comment about we do like posting. I will just remove it here, and that should be it. >> Okay. my sense is that this is enough change and reclarification and specific language that we ought to revote on this. I don't know what Robert of Robert's rules would say about how we do this but how about if we just raise a vote. okay, thank you. anybody going to second this one? Second. all in favor? >> Aye. >> Aye. >> Opposed? Abstentions? All right. thanks. David, thanks so much. all right. gosh, we've gotten through all the substantive work here. >> Properly. >> Oh, we have not. okay. let's see if we can get back to the biospecimens statement. can we do that? >> That's the new one that mark articulated last night. >> Right, the new biospecimen statement. >> We might not even need to look at it. >> Go ahead and describe your concern and then we'll see if folks are feeling comfortable with accepting that change without looking at the specific language. >> In your new complicated system of providing opt out there were opportunity for opt out, there were some passages that said if such and such happens and an individual has properly opted out, and that language appeared in three or four of that complicated scheme we set up and I had some concerns about saying was it properly opt out because I don't know what an improper opt out would be and sort of flagged that we would come back to that and change it and didn't realize that it was going to persist in mark's latest version, so I think we might be able to just say let's delete properly when it's used as a modifier for opt out in the biospecimen recommendations, that would be easy to find and delete. >> Didn't we actually do that actively for one instance during the discussion which would provide basis for this? >> Yes. >> Okay. I think we just need to consider that an oversight in the editing process and what we'll do is we finalize the documents as follow through on that complete deletion of that term and we'll be good. are there any other issues about the NPRm that either committee members or ex-officios or subcommittee members want to bring up for any consideration? All right. I think impressive work. I think we're going to be very proud of this set of recommendations, and hopefully we'll be able to get those out in the time that others will be able to take a look at what we've had to say and perhaps influence other comments that may come forward on the NPRm. we have a pun comment period now and I don't think we have anybody posted to actually speak to us. I have several letters that have been distributed to the committee members and I'm going to briefly summarize each of those for our public comment period here and bear with me on this. (inaudible). >> Oh, you do? Okay. and we have you on the-- you signed up on the list? (inaudible). >> All right. why don't you provide us then with comment. and I think as we've been trying to do encourage folks to stay within a five-minute time period for that. thank you. if you could produce yourself once again. (inaudible) >> Carla Smith, I'd like to thank this committee for giving me the opportunity to speak. I just want to mention a couple things, I apologize if you've gone through this, but regarding the definition of human subject and non-identified biospecimens, there's a statement about broad consent for future unspecified research, and I wanted to suggest that the definition be amended to specify the collection of biospecimen and not to be so broad as to specify future unspecified research, because that's a very broad term. and regarding-- I know you've gone through intelligence surveillance activities and you've decided that you don't have enough expertise for this, however I would like to suggest, giving you some information that you may not be aware of. and that is that in the NPRm it specifics the rationale for excluding defense or national security related activities is similar to that described above regarding public health service activities. it goes on to state that their activities are fundamentally not research. and they are not designed to develop or contribute to generalizable knowledge, rather they are solely conducted to fulfill the department or agency's legal mandate. those terms come directly from the common rule. and in the common rule, it says that research needs a system attic investigation, designed to develop or contribute to generalizable knowledge. so, again, I propose that the definition of research be amended to drop the criteria of generalizable knowledge. and additionally, when they state that they are soley conducted to fulfill a department or agency's legal mandate that comes from the common rule and definition of research subject regulation, it states that it does not include research activities which are incidentally regulated by federal department or agency, solely as department or agency broader responsibilities. et cetera. so just to give you a little background, the department of defense has a directive, 5240.1-r, that includes a procedure for experimentation on human subjects for intelligence purposes. it's referenced by three current DoD directives. and in moral science, which was published by the bioethics commission in 2011, in a footnote it states that sue Bromley, associate deputy director central intelligence agency wrote to Dr. Amy Guttman, the CIA confirmed all CIA sponsored human subjects research is conducted in the United States, not abroad. and that CIA personnel also met with the commission, et cetera. so, again, the CIA engages in human subjects research in the United States, they comply with the common rule. there are loopholes in the common rule that allow us to not be defined as human subjects. so, again, it's very important, and I also want to mention that past abuses of unethical and non-consensual human experimentation in the United States include bluebird, chatter, Mk, Mk Naomi, interwove within radiation experiments and research on chemical and biological weapons. U.S. military intelligence agencies funded the research, with the broad network of 'demic institutions such as Harvard, Johns Hopkins, Mit, Eli Lilly, American psychological association, the department of defense and CIA recently colluded with over the torture to weaken the standards for the definition of torture. it includes the national institutes of health, V.A., U.S. public health service, which is a primary division of what is known today as the departments of health and human services. I don't mean to take on the agencies but we need to look at history to know why we need to regulate such classified research. we also have Tuskegee, et cetera. recent violations include the support experiment conducted by NIH. the Uc Davis bacteria experiment, UC-SanFrancisco breathing support experiment, cafe trial involving Seroquill with the University of Minnesota halted trials, Respiridol and collusion to weaken guidelines to allow participation in government enhanced interrogation programs. Many citizens are reporting and continue to report to the bioethics commission that they are victims of this classified research. in a manner similar and consistent with Mk ultra, so again victims need protection. you don't have to believe the victims, you just need to close the loopholes to not permit it to happen. so given the recent information about human experimentation in the United States by intelligence military agencies, recent ethics violations, past abuses, and ongoing reports from citizens that they are victims, intelligence surveillance activity should not be exempt from oversight. and in 1997 President Clinton suggested that they set forth a proposal to prohibit waiver of informed consent for all class fight research and I feel it's incumbent upon everyone to consider this proposal. and one other note. department or agency heads retain final judgement as to whether a particular activity is covered by this policy. that should not be allowed to occur. because what if a department or agency decides that non-consensual research can occur, so I would encourage that loophole to be closed. I would also suggest removal of 46 -- >> Go ahead and bring to a conclusion. >> 46.101-c, to close the loophole with the agencies, these recommendations are essential to preventing misinterpretation of regulations, to promote clarity, transparency and uniformity and to take it into account advances in technology, science and medicine, particularly remote technologies. thank you. >> Thank you. I have several letters I'm going to briefly summarize. they have been distributed to the committee, I will only highlight a couple key elements from each of the comments. and encourage committee members to look at the full documents that have been submitted as they can so the first one I'm going to abstract from is Katherine Ryan from Monterrey, Massachusetts, this is November14 to the secretary's advisory committee and her thanks to us for work we are doing here and I think a number of interesting points I'm going to read what I think is probably the core paragraph. I'm strongly opposed to the proposed exemption of the intelligence/surveillance agency. we've day we're hear of abuses Snowden uncovered as an example, whistleblowers are seeing rights abused for truth telling while the CIA uncovered, redefining general terms which we all understand. I cannot emphasize enough the importance of not allowing any exemption for the intelligence agencies, run by a third party contractors. United States ethics has been better than that and majority of Americans wish our country to return to more ethical standards. she has an RN background in nursing. second letter is from Frederick Byhold from Framingham, Massachusetts. it's relevant to what says, my objection to the exemption of intelligence agencies, surveillance activities, described in the notice of proposed rule making at 101b-1/6, and so consistent with the number of comments we've heard, high lights a couple points here, some employees should be in jail for violating the U.S. constitution so I'm against giving these individuals any additional powers. further, the intelligence agencies have not convinced me they properly handed the power they have, therefore I'm disinclined to agree to giving them additional powers at this time. not convinced the real reasons for wanting additional powers to provide additional safety to the American people. point 14, I ask the committee not to participate in adding this potential new atrocity to all of the other recent atrocities committed since 9/11 at the hand of the U.S. government. this letter is from Phyllis-- Dr. Phyllis Cheribini, former educator. thank you for your work. the main area of concern is that of intelligence activities, most informed people are aware the intelligence community has in the past engaged in non-consensual human experimentation, then mentioning Mk ultra and impro, these people should not be exempt from the regulations that bona fide researchers must follow, as long as intelligence operations and those under their auspices are allowed to for no verifiable regulations, we're all they mercy of the conscionable in this community. the plea is to not support the exclusion, from Cynthia Mary from Milton, Massachusetts. I intend to focus on the purpose of the regulatory action which states individuals who are the subject of research may be asked to contribute their time and assume risk to advance research enterprise which benefits society at large, and she raises concern about the term "subject" itself, and making a parallel between individuals sort of being subject to a king and that's not consistent with she would like to suggest as the notion of humans within our constitutional structure. so, quote, with this in mind and heart in order for a human being to be a subject there must be consent and agreement, nobody especially the government in peace or war has the right to turn human beings into subjects without their clear consent and agreement. she mentions scientific atrocities of the past, Joseph mengele, Guantanamo, research with wards of the state, the voice of the people, present at these commission meetings. thank you to all those folks for contributing their statements. any other business for the committee today? Our next meeting is -- >> I wanted to stress to everyone there is no march meeting. there's no regularly scheduled march meeting because this in effect is the march meeting, next meeting is going to be may 18th and 19th of SACHRP, at this location. >> We'll reintroduce ourselves at that point. so that raises one final point. first of course, thanks to the committee for everybody working hard on this, and creating a document that I think is excellent, certainly the subcommittee chairs have done extraordinary work. they will be happy to see this-- see us revert back to our normal mode of operation with topics and we'll have to remind ourselves where we are at this point. my thanks to Hrp for their support and I think the fact that Jerry is here for the entire meeting and participates in discussions I think is supportive of the careful analysis that we have done and I have not heard anything that suggests from Ohrp's standpoint that the book is closed on any of these recommendations. we understand Ohrp while the point of the spear here and probably the public face of this process that there are many other big players who are involved in this whole process and that Ohrp has been a great colleague for us in thinking about these issues and there will be a lot of folks involved in the decisions about what formulates into the final rule. my thanks. Jerry, any final comments? >> Just thank you, everybody. it's wonderful work, a great two-day meeting and incredibly helpful on our end. thank you so much. >> All right.