>> NANCY, WOULD GET US STARTED. >> NANCY KING, FROM WAKE FOREST SCHOOL OF MEDICINE. >> HOLLY, FROM THE UNIVERSITY OF PENNSYLVANIA. >> LESLIE WILSON, GEORGIA STATE UNIVERSITY COLLEGE OF LAW. >> JEFF WITH THE DEPARTMENT OF ED. >> KAREN GENES V. A. >> ANDREA WITH NATIONAL INSTITUTE OF TECHNOLOGY. >> JOANNE WITH THE OFFICE OF CLINICAL PRACTICE, IT'S BEEN A LONG MORNING ALREADY AT FDA. >> MARISAA, HHS, OFFICE FOR CIVIL RIGHTS. >> SANDY WITH THE RAND CORPORATION. >> ALICIA, WITH THE UNIVERSITY OF PITTSBURGH. >> STEVEN ROSENFELD, OIRB. >> [INDISCERNIBLE] >> [INDISCERNIBLE] >> ARE THERE ANY EXOFICIOs IN THE AUDIENCE WHO WOULD IDENTIFY THEMSELVES? THANK YOU. ALL RIGHT. BEFORE WE GET STARTED WITH THE--SO, 1 COMMENT. WE HAVE 4 PEOPLE WHO ARE ABSENT, EXPECTED TO BEABSENT FOR SACHRP MEMBERS IT IS IMPORTANT THAT YOU'RE HERE FOR THE DELIBERATIONS BECAUSE WIREOT EDGE OF QUORUM, SO JUST A REMINDER FOR THE NEXT COUPLE OF DAYS. AND THEN HOUSEKEEPING. I HOPE YOU'VE ALL HAD A CHANCE TO LOOK AT THE MINUTES FROM OUR LAST MEETING AND I WOULD ENTERTAIN A MOTION TO APPROVE? SECOND? >> SECOND. >> MOVE AND SECONDED TO APPROVE THE MINUTES FROM OUR LAST MEETING. DISCUSSION? ALL IN FAVOR SAY AYE. MOTION PASSED. THANK YOU. ALL RIGHT, SO NOW WE PROCEED WITH THE AGENDA. JERRY INTERESTING TO START US OFF WITH. >> FIRST I WOULD LIKE TO WELCOME EVERYBODY. I WANT TO THANK IN PARTICULAR THE MEMBERS OF THE SACHRP MEMBERS, EXOFFICIOS, MANY PEOPLE WHO HAVE BEEN WORKING ON VARIOUS ISSUES SINCE LAST MEETING, THANK YOU ALL FOR THE WORK THAT LED UP TO TODAY'S MEETING. I'M SURE IT WILL BE A VERY INTERESTING 1 AND WE--WE ON BEHALF OF OHRP VERY MUCH APPRECIATE ALL OF YOUR WORK. JUST TO BRING--MENTION 1 NOTABLE UPDATE, I KNOW A LOT OF YOU ARE AWARE OF, RELATIVELY RECENTLY THERE WAS A NOTICE OF PROPOSED RULE MAKING THAT WAS SENT FROM HHS TO THE OFFICE OF MANAGEMENT AND BUDGET. IT IS TITLED PROPOSED 1 YEAR DELAY OF THE GENERAL IMPLEMENTATION DATE WHILE ALLOWING USE OF 3 BURDEN REDUCING PROVISIONS DURING THE DELAY YEAR. AND JUST READ YOU A STATEMENT THAT HAS BEEN ISSUED BY THE PUBLIC AFFAIRS OFFICE WITHIN HHS. AND I'LL JUST NOTE, THIS IS A PROPOSED RULE, OF COURSE IT'S A NOTICE OF PROPOSED RULE MAKING SO IT'S JUST PROPOSED AT THE MOMENT. THE RULE IS NOW UNDER REVIEW AT THE OFFICE OF MANAGEMENT AND BUDGETS OFFICE AT INFORMATION AND REGULATORY AFFAIRS, ALL NOTICES OF PROPOSED RULE MAKING ARE REQUIRED TO GO THROUGH THE FORMAL RULE MAKING PROCESS, IT IS HHS POLICY NOT TO DISCUSS DETAILS OF SUCH PROPOSALS, BEFORE THEY APPEAR IN THE FEDERAL REGISTER FOR PUBLIC COMMENT. SO THAT WAS THE STATEMENT ISSUED BY HHS. SO ON BEHALF OF OHRP, WE ARE NOT PERMITTED TO ACTUALLY DISCUSS THE CONTENT OF THAT RULE OR OF THAT PROPOSAL. YOU DO HAVE THE TITLE, YOUR PEOPLE ARE CERTAINLY ABLE TO KIND OF TRY TO FIGURE OUT WHAT IT'S TALKING ABOUT FROM THAT, BUT JUST SO IT'S NOT OUR BEING OBSTRUCTIONIST IN ANY WAY BUT WE'RE JUST FOLLOWING HHS POLICY. SO THAT'S THE ONLY THING I WANTED TO MENTION. >> THANK YOU JERRY SO I'LL SECOND THE WELCOME. I AM STILL RELATIVELY NEW TO THIS ROLE AND PARTICIPATE WHEN I CAN IN THE SUBCOMMITTEE MEETING WHEN I CAN BY PHONE. THANK YOU SUBCOMMITTEE. WE ARE DEALING WITH THINGS ON THE SURFACE BARELY STRAIGHT FORWARD, MANY OF THE CHANGES BUT THEN WHEN YOU SCRATCH THE SURFACE THERE ARE ENORMOUS COMPLEXITIES AND THE SUBCOMMITTEES HAVE REALLY BEEN TRYING TO DEAL WITH THAT I THINK DOING A WONDERFUL JOB AND YOU'LL SEE THE FRUIT OF THAT TODAY. SO I WOULD SECOND JERRY'S THANK YOU TO THEM. AND THEN I GUESS WE'RE A LITTLE BIT AHEAD OF SCHEDULE BUT THAT'S GOOD. AND WE CAN GET STARTED WITH THE FIRST AGENDA ITEM WHICH IS DR. LAU, INTRODUCING OHRP'S PUBLIC OUTREACH WEBSITE. >> SO GOOD MORNING, EVERYBODY. YOU CAN HEAR ME WELL? SO I'M EXCITED TO HAVE THIS OPPORTUNITY TODAY TO TELL YOU ALL ABOUT THIS PROJECT THAT OHRP HAS BEEN WORKING ON AND WE LAUNCHED IT AT THE BEGINNING OF THIS YEAR. SO AS YOU ALL KNOW VERY WELL, THIS IS--TRYING TO GET THIS TO WORK. ALL RIGHT, SO ALL OF YOU KNOW VERY WELL OUR MISSION, RIGHT. HOWEVER, IN ORDER TO SUPPORT THIS MISSION, PARTY OF THE RESPONSIBILITY OF THE DIVISION OF EDUCATION AND DEVELOPMENT IS ALSO TO CONDUCT PUBLIC OUTREACH AND EDUCATION OR INFORMATION PROGRAMS TO PROMOTE AND ENHANCE PUBLIC AWARENESS OF OHRP AND HUMAN SUBJECTS PROTECTION, SO THIS HAS ALWAYS BEEN 1 OF OUR MANDATES AND THE REASON THAT THIS IS AN IMPORTANT THING IS THAT AS MANY OF YOU HAVE EXPRESSED THIS OVER THE YEARS AND WE'VE HEARD FROM THE GENERAL COMMUNITY FROM THE PUBLIC THAT THERE'S REALLY THE NEED TO HAVE INFORMATION, RELIABLE INFORMATION TO LEARN ABOUT RESEARCH AND TO UNDERSTAND ABOUT RESEARCH PARTICIPATION AND THE REASON THAT WE THINK THAT THIS IS AN IMPORTANT PART IS THAT IT'S REALLY IMPORTANT FOR IT AS A WAY TO PROMOTE ETHICAL RESEARCH WITH APPROPRIATE PROTECTIONS AND ALSO TO IMPROVE THE PROTECTIONS FOR RESEARCH, VOLUNTEERS AND HOPEFULLY BY DOING THAT AND TO LEVELING THE PLAYING GROUND THAT WE COULD ACTUALLY DEVELOPED TRUST PARTNERSHIPS, MUTUAL TRUST AND PARTNERSHIPS. SO THIS IS AN IMPORTANT AGENDA TO PROMOTE PUBLIC TRUST AND FROM OHRP'S POINT OF VIEW, WE ARE UNIQUELY POSITIONED TO DO THIS. BECAUSE IF YOU LOOK AT, YOU KNOW THE REASON FOR ALL THIS, YOU KNOW THESE ARE THE REASONS FOR EXISTENCE IF YOU LIKE. THESE ARE THE REASONS WHY WE ARE HERE. TO PROMOTE THIS PROTECTIONINGS FOR THE PUBLIC, PROMOTE ETHICAL AND SOUND RESEARCH DESIGNS. SO, BY--I THINK THAT, YOU KNOW, IN THE CASE OF OHRP, WE CAN GIVE THE PUBLIC A SOURCE OF INFORMATION THAT IS RELATIVELY FREE OUT OF THE COMPETING INTEREST AND CONFLICTS IF YOU LIKE. SO IN JANUARY THIS YEAR, WE LAUNCHED THIS WEBSITE CALLED ABOUT RESEARCH PARTICIPATION. WE ALSO AS YOU ALL KNOW, YOU KNOW SOMETIMES IF YOU GO TO OHRP'S WEBSITE, IT'S REALLY HARD TO FIND INFORMATION. SO WE ALSO FOUGHT TO GET THIS, WHAT THEY CALL VANITY URL, BASICALLY IT'S JUST HH HHS.GOV/PARTICIPATION. SO IT'S EASY FOR PEOPLE TO REMEMBER AND EASY THEREFORE FOR PEOPLE TO GET TO. INDEED IF YOU TYPE INTO GOOGLE, HHS, ABOUT RESEARCH PARTICIPATION, IT WILL GIVE YOU THE LINK TO THIS WEBSITE. SO WE LAUNCHED THIS AT THE BEGINNING OF THIS YEAR AND THE GOAL FOR US TO WAS TO POST MATERIALS THAT ARE RELEVANT AND MEANINGFUL TO POTENTIAL RESEARCH PARTICIPANTS. WE WANT THIS INFORMATION TO--WE WANT THE RESEARCH PARTICIPANTS OR POTENTIAL RESEARCH PARTICIPANTS TO FIND THIS INFORMATION USEFUL, MEANINGFUL IN THE SENSE THAT IT COULD HELP THEM IF THEY WERE THINKING ABOUT PARTICIPATING IN RESEARCH. IT COULD HELP THEM TO MAKE GOOD INFORMED DECISIONS. IN DELIVERING OR IN PRODUCING THE CONTENT OR THE MATERIALS, WE ALSO PAY A LOT OF ATTENTION TO THE ACCURACY. THAT IS A CHALLENGE TO PROVIDE INFORMATION THAT IS ACCURATE AND THAT IT'S IMPARTIAL. WE ALSO WANT TO SAY THAT, YOU KNOW WE DON'T WANT TO EMBELLISH UNNECESSARILY AND WE WANT THIS INFORMATION TO BE SINCERE AND DOWN TO EARTH. NOW, WE ALSO NEED TO PRESENT THIS INFORMATION IN PLAIN LANGUAGE THAT IS UNDERSTANDABLE AND THAT IS ALSO AT THE SAME TIME ENGAGING AND I THINK FOR ALL THOSE OF YOU WHO HAVE TRIED TO PRODUCE INFORMATION SUITABLE FOR PUBLIC COMSUMPTION THAT THERE IS A CHALLENGE TO HAVE THE ACCURACY, TO BE NOT PATRONIZING, TO ACTUALLY BE ABLE TO GIVE THAT INFORMATION ACCURATELY. SO THAT IS ALWAYS A CHALLENGE FOR OUR TEAM. AND WE ALSO AIM TO PROVIDE THE MATERIALS IN BOTH ENGLISH AND SPANISH AS MUCH AS POSSIBLE. AND THEN, THE LAST CHALLENGE IS VERY MUCH A FEDERAL GOVERNMENT 1 TO PROVIDE THIS MATERIALS WITH, YOU KNOW THAT COMPLY WITH THE SECTION 508 REQUIREMENT WHICH IS PEOPLE WITH DISABILITIES WOULD BE ABLE TO ACCESS THAT AND SOMETIMES THAT LIMIT THE FORMAT IN WHICH WE CAN ACTUALLY USE TO DEVELOP THIS CONTENT. SO IN TERMS OF CONTENT DEVELOPMENT, THIS IS THE POINT WHERE I CAN ACTUALLY BRAG A LITTLE BIT ABOUT MY TEAM. SO WITHIN THE DIVISION OF EDUCATION AND DEVELOPMENT WE REALLY HAVE A GREAT TEAM TOGETHER. WE HAVE PEOPLE WITH BACKGROUND IN MEDICINE, LAW, BIOETHICS, EDUCATION, SCIENCE, PUBLIC EDUCATION AND THAT IS A GREAT, GREAT ASSET. SO WE DEVELOP THE IDEAS IN RESPONSE TO OUR PERCEIVED NEEDS. OF COURSE, AS YOU KNOW OUR TEAM GOES AROUND THE COUNTRY TO DELIVER WORKSHOPS AND TO SPEAK WITH STAKEHOLDERS. THIS--WE REALLY REPRESENT THE OUTWARD SIDE OF OHRP SO WE GET TO HEAR A LOT FROM STAKEHOLDERS. WE HAVE IDEAS, WE FORMULATE THESE IDEAS, WE TALK TO OUR OHR--HHSOASH, COLLEAGUES AND MEDIA AND COMMUNICATIONS. WE TALK WITH OUR OWN COLLEAGUES IN THE OFFICE AND WE WOULD ALSO LOOK INTO WHAT'S AVAILABLE ALREADY OUTSIDE AND SEE HOW WE CAN ACTUALLY MAKE A DIFFERENCE THERE OR NOT. SO WE DON'T REALLY WANT TO--SO YOU WILL FIND THAT YOU KNOW OFTEN IF IT'S VERY SCIENTIFICALLY CENTERED MATERIALS OR IF IT'S LIKE DEFINITIONS THAT WE REALLY CANNOT IMPROVE FURTHER ON, WE WOULD PROBABLY JUST UTILIZE AND RECYCLE OTHER PEOPLE'S IDEAS BY PUTTING A LINK IN OUR SITE THAT PEOPLE CAN GO TO AND A GOOD EXAMPLE OF THAT IS, YOU KNOW, THE GLOSSARY OF TERMS FOR EXAMPLE, TERMS THAT WE USE OFTEN IN CLINICAL RESEARCH AND OUR TEAM STARTED THINKING ABOUT OKAY, MAYBE WE SHOULD WORK ON THIS AND LOW AND BEHOLD, WE FIND THAT A-ACTUALLY CLINICAL TRIALS.GOV HAVE A GREAT GROSSRY AND IF WE DO THIS WE WOULD REPEAT DEFINITIONS, SO THERE'S NO NEED TO DO THAT AND THERE'S A VERY RELIABLE SOURCE OF INFORMATION. SO WE INCLUDE A LINK IN OUR SITE TO GET THERE. SO ANYWAY, WE WOULD DEVELOP THE CONTENTS AND WE WOULD GET STAKEHOLDERS INPUT, STAKEHOLDERS CAN BE FROM THE RESEARCH COMMUNITY, BE INVESTIGATORS, IT COULD ALSO BE IRB FOLKS, CLINICAL TRIAL COORDINATORS, PATIENTS THEMSELVES, PEOPLE WHO HAVE PARTICIPATED IN RESEARCH IN THE PAST SO WE GET THEIR INPUTS, THERE IS A LIMIT TO HOW MUCH WE CAN DO THERE AS MANY OF YOU KNOW AND THEN WE GATHER ALL THE COMMENTS AND WE GET THIS--YOU KNOW OUR TEAM WOULD WRITE AND DEVELOP THIS CONTENTS. HERE AGAIN IS ANOTHER CHANS FOR ME TO JUST SAY THANK YOU TO SOME OF THE CONTRACTORS THAT WE WORK WITH. WE HAVE EFFECTIVE COMMUNICATIONS THAT HELP US DEVELOP THE IMAGES AND GIVING US ADVICE AS HOW HO TO DELIVER THE CONTENTS AND ENGAGING MANNER. AT THE END OF THE DAY WHEN WE DONE DEVELOPING THE CONTENT AND IT'S READY, WE ALSO HAVE ANOTHER SET OF CONTRACTORS, DS FEDERAL THAT WOORK--WORK WITH US CLOSELY TO GET WITH THE MATERIAL ON THE WEBSITE TO MAKE SURE IT'S 508 COMPLIANT AND TO SATISFY ALL THE REQUIREMENTS THAT HHS REQUIRES. SO THIS IS AN ONGOING PROJECT. NOTE THIS IS NOT A 1-OFF COMPAIN. SO THIS WEBSITE IS HOST ON OUR OHRP WEBSITE, IT'S EASY TO GET TO BECAUSE IT HAS THE VANITY URL ABOUT RESEARCH PARTICIPATION. CURRENTLY THERE ARE--ACTUALLY IN THIS MOMENT IN TIME, THERE ARE 3 SECTIONS, INFORMATION VIDEOS, QUESTIONS TO ASK, AND AKIGZAL RE--ADDITIONAL RESOURCES, THE THIRD ITEM PROTECTING RESEARCH PARTICIPATION IS A SET OF INFO GRAPHICS THAT WE ACTUALLY ARE IN THE PROCESS OF GETTING 508 COMPLIANCE CLEARANCE AND THAT WE WILL BE POSTING ON OUR WEBSITE SOON. IN YOUR FOLDERS AND OUTSIDE ON THE TABLE, WE PROVIDED A SET OF THESE INFO GRAPHICS SO YOU CAN SEE WHAT THEY ARE BUT I WILL TALK ABOUT THAT A BIT LATER. SO AS WE PLIEWF FORWARD WITH THIS PROJECT, WE ARE PROBABLY AT SECTIONS WITH THE CONTENT. WE MAY ALSO ADD VARIOUS THINGS LIKE FOR EXAMPLE VIDEOS. THIS IS THE PAGE THAT SHOW INFORMATIONAL VIDEO WHEN IS WE FIRST LAUNCH IT, WE LAUNCHED IT WITH 3 SETS OF VIDEOS, PART 1, 2, 3, WHAT IS CLINICAL RESEARCH TRIALS AND QUESTION ITS ASK AND VERY, VERY RECENTLY, LITERALLY ABOUT A WEEK AGO, WE ALSO RELEASE SAID THE NEW VIDEO ON RANDOMIZATION WHICH I WILL SHOW YOU IN A MINUTE. SO ALL THESE VIDEOS ARE SHORT, 3-4 MINUTES BIT'S SOMETIMES HARD BECAUSE YOU CAN SEE WITH RANDOMIZATION, WE HAVE LET IT FLOW UP TO ABOUT 7 MINUTES. I ALSO WANT TO DRAW YOUR ATTENTION TO THIS, TO THE ASK PAGE. THIS IS WHAT YOU SEE ON THE ACTUAL WEBSITE. IT'S PRECEPTED BY INFO GRAPHICS AND IF YOU HOVER OVER THE ARROWS THE BOX WILL COME UP AND GIVE YOU THE SET OF QUESTIONS IF ARE THAT PARTICULAR SECTION. SO IT'S VERY EASY TO READ ON THE MOBILE DEVICES. OT OTHER--AT THE SAME TIME YOU SEE PRINT BUTTON AT THE TOP AND THEA THE BOTTOM AND WHEN IT'S PRINTED OUT THAT'S WHAT YOU GET PRINCIPLE, 2 PAGER YOU CAN PRIPT ON BOTH SIDES AND IT'S ACTUALLY LARGE FONTS AND EVERYTHING AND IT'S DISPLAYED IN THE MANNER THAT EASY TO REFER TO AND YOU APOLOGIZE THE 1S IN YOUR FOLDER IS A LITTLE BIT PRINTED OFF-SIDED AND THAT'S PARTLY BECAUSE OF OUR OLD PRINTER, UNFORTUNATE. BUT ANYWAY, IT SHOULD LOOK LIKE THIS. NICE AND PRETTY. SO WE MAY A LOT AS YOU SEE BECAUSE THIS THESE ARE THINGS WE DELIVER TO THE PUBLIC. WE PAY ATTENTION TO HOW THINGS LOOK AND HOW THINGS THAT THEY WOULD SEE THEM AND THE CONTENT IS VERY IMPORTANT AND SO, ON THIS QUESTIONS TO ASK LIST, WE INCLUDED THE LIST OF VERY COMPREHENSIVE QUESTIONS THAT WE THINK ARE POTENTIAL PARTICIPANT IS LIKELY TO WANT TO ASK IN ORDER TO MAKE AN INFORMED DECISION IF THEY WERE APPROACHED TO PARTICIPATE IN RESEARCH. NOTICE THAT THESE ARE IN QUESTION FORMATS. WE DID IT LIKE THAT BECAUSE WE THINK THAT PRESENTING THEM AS QUESTIONS FORMAT, IT'S NOT ONLY THEY CAN TAKE THIS, DOWNLOAD THIS, PRINT THIS, LOOK AT IT, THINK ABOUT IT, SO THEY'RE ASKING THE QUESTIONS TO THEMSELVES ALREADY, ALL RIGHT IN BUT ALSO THAT THEY CAN TAKE THIS AS A KIND OF CHECK LIST, IF THERE WERE PARTICULARLY QUESTIONS THAT INTEREST THEM AND THEY WANT TO ASK THEIR RESEARCH, THEY CAN TAKE THIS WITH THEM AND LOOK AT IT AND ASK, YOU KNOW HOW IT IS WHEN YOU GO TO AN INVESTIGATOR OR YOU TALK TO A DOCTOR, SOMETIMES YOU HAVE ALL THESE QUESTIONS AT HOME AND BY THE TIME YOU GET THERE, ALL OF A SUDDEN IT'S ALL FORGOTTEN AND I KIND OF MIXED IT ALL UP AND GET CONFUSED. HAVING SOMETHING LIKE THAT IS, YOU KNOW IT'S HELPFUL, IT'S REISSUED, IT REMINDS YOU. SO THAT IS REALLY THE PURPOSE THAT WE DID IT FOR. THE QUESTIONS ARE GROUPED TOGETHER IN MANNERS THAT WE THINK WOULD MAKE SENSE TO THE POTENTIAL PARTICIPANT. HOPEFULLY THAT WOULD STRENGTHEN HOW--STREMGHTENLET CONTEXT--STRENGTHEN THE CONTEXT UNDER WHICH THE INFORMATION IS SOUGHT. AND AGAIN LIKE I SAID, IT'S PRINTABLE ON A SHEET OF PAPER AND WE THINK THAT IS NOT REALLY JUST--YOU KNOW POTENTIAL PARTICIPANTS CAN TAKE THIS ALONG WITH THEM AND USE THEM BUT AT CLINICS OR AT THE RESEARCH CENTERS, RESEARCH STAFF CAN POSSIBLY USE THIS AS A TOOL TO REMIND THEM OR TO CHECK WITH THEIR, YOU KNOW WITH THE POTENTIAL PARTICIPANTS AS TO WEATHER THE INFORMATION HAS BEEN DELIVERED AND HAVE UNDERSTOOD IT IN THE WAY THAT IS PRESENTED HERE. SO THIS IS THE SET OF INFO GRAPHICS THAT WE'RE ABOUT TO LAUNCH AND WE LAUNCH IT ON THE SIDE UNDER PROTECT VOLUNTEERS. SO THIS IDEA CAME ABOUT, WE WERE THINKING, OKAY, WELL, A LOT OF PEOPLE DON'T REALLY KNOW MUCH ABOUT WHAT SORT OF PROTECTIONS, WHAT ARE THESE PROTECTIONS, WHAT SORT OF PROTECTIONS ARE THERE AND UNDER WHAT SITUATIONS WOULD I GET SOME OF THESE PROTECTIONS? SO OF COURSE WE DEVELOP THIS FROM THE PERSPECTIVE OF OHRP WE HAVE TO SAY AND THERE ARE 5 TAPS TO THIS, THERE'S A LANDING PAGE AND THERE'S A 5 TAP TO THIS, WHY REGULATIONS, SO HOW DO THE REGULATIONS COME ABOUT? THE PRINCIPLE REGULATIONS, AND WE'RE TALKING ABOUT 45 CFR 46 OF THE COMMON RULE, WHO OVERSEES AND ENFORCES THIS REGULATION? AND THEN UNDER THE OTHER REGULATION, AS YOU KNOW A LOT OF RESEARCH IS NOT NECESSARILY UNDER THE COMMON RULE, THE FEDERAL OR HHS OVERSIGHT. SO WE TELL THEM ALSO, LIKE, OKAY, WHAT MAY BE OTHER PROTECTIONS THAT ARE AROUND. WE MENTION FDA OF COURSE, AND THEN WE TALK ABOUT SHARED RESPONSIBILITY. WE WANT TO REALLY BRING OUT THIS IDEA THAT IT IS REALLY--EVERYBODY IS INVOLVED IN THIS, AND IT'S NOT, JUST 1 GROUP OF PEOPLE DOING EVERYTHING BUT IT IS SHARED AMONG REGULATORS, SPONSORS, THE INSTITUTIONS, IRBs, EVEN THE POTENTIAL, OR THE PARTICIPANTS, RESEARCH PARTICIPANTS THEMSELVES. SO, YOU ALSO HAVE A SET OF THIS INFO GRAPHICS IN THE FOLDER, AGAIN, THERE WAS PRINTING ISSUE, BUT THE 1S OUTSIDE ON THE TABLE, THEY'RE PRINTED MORE NICELY. AND THEN THERE'S THE ADDITIONAL RESOURCES SECTION, LIKE I SAID, WE TRY TO UTILIZE SOME OF THE AVAILABLE INFORMATION NORMALLY, WE DO NOT ACCEPT ANY KIND OF PEOPLE SOLICITING PUTTING THEIR WEBSITE ON HERE BECAUSE IT'S HARD FOR US TO REVIEW ALL THIS MATERIAL AND TO MAKE A DECISION AS TO OKAY, WELL, IF WE PUT THIS GROUP'S MATERIAL ON IT, DOES IT MEAN THAT, YOU KNOW OTHER GROUP'S IS NOT PUT ON IT THAT THEIR MATERIAL IS NOT AS GOOD SO WE DON'T REALLY WANT TO ENTER INTO THAT ARENA. WE TEND TO LIMIT OURSELVES TO FEDERAL WEBSITES IF POSSIBLE AND LIKE I SAID, YOU KNOW, OUR TEAM DOES GO OUT AND LOOK AT DIFFERENT RESOURCES AND IF WE REALLY SEE THAT, YOU KNOW A CERTAIN SET OF RESOURCES IS, YOU KNOW HAS OVERWHELMING POSITIVE OR MEANINGFUL IMPACTS, POSSIBLY WE'LL CONSIDER AND TALK TO OUR OHRP COLLEAGUES AND SEE WHETHER IT'S SUITABLE TO INCLUDE IT. SO, I THINK IT'S TIME FOR US TO REVIEW A CLIP. >> LET ME JUST ASK YOU IF THIS IS WHAT IT'S LIKE TO ASK PAGE AND IF YOU OVER OVER IT AND SEE THE LIST OF QUESTIONS, OF COURSE YOU CAN EASILY CLICK THE PRINT BUTTON AND GO TO WHAT WE--A PAGE LIKE THIS AND THEN YOU CAN EASILY PRINT AND DOWNLOAD THAT. >> THE FEDERAL OFFICE FOR HUMAN RESEARCH PROTECTIONS OR OHRP, CREATED THESE VIDEOS TO LET YOU LEARN MORE ABOUT PARTICIPATE NOTHING RESEARCH. DECIDING IF YOU WANT TO VOLUNTEER FOR A RESEARCH STUDY CAN BE DIFFICULT AND THIS DECISION CAN HAVE IMPORTANT CONSEQUENCES. RESEARCH THAT COMPARES INTERVENTIONS OR TREATMENTS COMMONLY USES RANDOMIZATION AS PART OF THE STUDY DESIGN WHICH MEANS THAT VOLUNTEERS ARE ASSIGNED RANDOMLY TO PARTICULAR STUDY ARMS OR GROUPS. WHICH INTERVENTION OR TREATMENT THE VOLUNTEERS RECEIVE DEPENDS ON THE STUDY ARM THEY ARE ASSIGNED TO. THIS VIDEO PROVIDES BASIC INFORMATION ABOUT WHY RESEARCHERS USE RANDOMIZATION IN STUDIES AND WHAT RANDOMIZATION MEANS TO YOU AS A POTENTIAL RESEARCH VOLUNTEER. WHEN SOMETHING HAPPENS RANDOMLY, THAT MEANS IT HAPPENS COMPLETELY BY CHANCE AND THAT NO 1 CAN PREDICT OR CONTROL THE RESULT. DRAWING NUMBERS OUT OF A HAT TO SEPARATE PEOPLE INTO 2 TEAMS IS A RANDOM PROVEEDURE. SO IS FLIPPING A COIN TO DECIDE WHO GOES FIRST IN A GAME. RANDOMIZATION IS A COMMONLY USED PROCEDURE IN CLINICAL RESEARCH. RESEARCH VOLUNTEERS MAY BE RANDOMIZED TO DIFFERENT ARMS IN A STUDY. THIS MEANS THAT A VOLUNTEER'S ASSIGNMENT TO A PARTICULAR STUDY ARM IS BY CHANCE AND THAT IT IS NOT PLANNED OR CONTROLLED BY THE RESEARCHER, THE VOLUNTEER'S DOCTOR OR ANYONE ELSE. WHICH STUDY ARM A VOLUNTEER ENDS UP IN IS RANDOM, LIKE WHETHER A COIN FLIP COMES UP HEADS OR TAILS, WITHOUT ANY INPUT FROM THE STUDY TEAM. RESEARCHERS USE RANDOMIZED ASSIGNMENT TO HELP GET RELIABLE ANSWERS TO RESEARCH QUESTIONS. SUPPOSE RESEARCHERS WANT TO KNOW IF A NEW DRUG CAN HELP PEOPLE FIGHT AN INFECTION BETTER THAN WOAN ALREADY BEING USED. THEY AND--ENROLL VOLUNTEERS WHO HAVE THE TYPE OF INFECTION THE DRUGS ARE SUPPOSED TO TREAT AND THEN THEY RANDOMLY ASSIGN VOLUNTEERS TO 1 OF 2 STUDY ARMS. IN 1 STUDY ARM, VOLUNTEERS RECEIVE A DRUG THAT IS CURRENTLY PRESCRIBED BY DOCTORS. VOLUNTEERS IN THE OTHER STUDY ARM RECEIVE THE NEW EXPERIMENTAL DRUG. THEN, RESEARCHERS COLLECT INFORMATION ABOUT HOW THE VOLUNTEERS IN EACH GROUP RESPOND TO THE DIFFERENT DRUGS. IF THE RESEARCHERS GET TO DECIDE WHO GETS WHICH DRUG AND DON'T USE RANDOMIZATION, THEY MIGHT UNINTENTIONALLY GIVE PEOPLE WHO SEEM SICKER, THE NEW DRUG, PERHAPS BECAUSE THEY THINK THE NEW DRUG MIGHT WORK BETTER OR MAYBE THEY WOULD GIVE SICKER VOLUNTEERS, THE COMMONLY USED MEDICINE BECAUSE THEY HAVE MORE EXPERIENCE WITH IT, BUT IF EITHER OF THOSE THINGS HAPPEN THE RESULT OF THE STAD--STUDY WOULDN'T TELL RESEARCH RESEARCHERS WHETHER 1 DRUG REALLY WORKS BETTER THAN THE OTHERS BECAUSELET VOLUNTEERS IN EACH ARM ARE 2 DIFFERENT FROM EACH OTHER. A DIFFERENCE IN RESULTS BETWEEN THE 2 STUDIES ARMS MIGHT OCCUR JUST BECAUSE 1 ARM INCLUDES SICKER VOLUNTEERS. TO MAKE SURE THAT ANY DIFFERENCES IN RESULTS BETWEEN THE STUDY ARMS ARE CAUSED ONLY BY THE DIFFERENT DRUGS, THE VOLUNTEER GROUPS NEED TO BE SIMILAR IN HEALTH AND IN OTHER CHARACTERISTICS LIKE THE SAYING GOES, IT'S IMPORTANT TO COMPARE APPLES WITH APPLES. RANDOMIZATION IS SUPPOSED TO HELP MAKE THE GROUPS MORE SIMILAR. WHEN VOLUNTEERS ARE ASSIGNED RANDOMLY TO THE STUDY ARMS, NO 1 CONTROLS WHICH GROUP OF VOLUNTEER WILL BE IN. THEREFORE, AS LONG AS THERE ARE ENOUGH VOLUNTEERS, THE STUDY ARMS SHOULD BE SIMILAR. IN OUR EXAMPLE, EACH STUDY ARM WOULD HAVE ROUGHLY THE SAME NUMBER OF VOLUNTEERS WITH MILD AND SERIES POINTSIOUS INFECTIONS AND BE GENERALLY SIMILAR IN OTHER CHARACTERISTICS. THIS WAY, THE ONLY THING THAT IS DIFFERENT BETWEEN THE 2 GROUPS, IS THE DRUG THEY TAKE. THE RESEARCHERS CAN BE MORE CERTAIN THAT ANY DIFFERENCES IN THE RESULTS ARE CAUSED BY THE DRUGS BEING STUDIED AND NOT THE CHARACTERISTICS OF THE VOLUNTEERS IN THE GROUPS. THIS IS WHY RANDOMIZED STUDIES CAN PRODUCE MORE RELIABLE RESULTS. SOMETIMES RESEARCHERS TAKE ADDICTIONAL STEPS TO AVOID UNINTENTIONALLY INFLUENCING THE RESULTS, FOR EXAMPLE, THEY MAY DESIGN THE STUDY SO THAT VOLUNTEERS WON'T KNOW OR ARE PLIENDED TO WHICH GROUP THEY ARE IN. OTHER TIMES BOTH THE RESEARCHERS AND THE VOLUNTEERS DON'T KNOW WHICH GROUP THE VOLUNTEERS ARE IN. THIS IS CALLED A DOUBLE BLIND STUDY. IT IS INSURES THAT NO 1 CAN INTENTIONALLY OR UNINTENTIONALLY INFLUENCE THE RESULTS. DOUBLE BLIND RANDOMIZED STUDIES ARE 1 OF THE BEST RESEARCH BESIGNS AND GENERALLY PRODUCE THE MOST RELIABLE RESULTS. IF YOU ARE ASKED TO PARTICIPATE IN A RESEARCH STUDY WITH A RANDOMIZED DESIGN, HERE'S WHAT YOU NEED TO KNOW. YOUR ASSIGNMENT TO A PARTICULAR STUDY ARM OR GROUP IS DONE RANDOMLY LIKE A COIN FLIP. THE RESEARCH TEAM CANNOT CHOOSE WHICH GROUP YOU END UP IN. SIMILARLY, YOUR DOCTOR CANNOT CHOOSE WHICH STUDY ARM YOU END UP IN EACH IF HE OR SHE THINKS THAT 1 GROUP MIGHT BE BETTER FOR YOU THAN THE OTHER. YOUR ASSIGNMENT TO A STUDY ARM IS ENTIRELY BY CHANCE. YOU ALSO CANNOT CHOOSE WHICH GROUP YOU ARE IN AND YOU MAY NOT GET THE 1 THAT YOU WANT. IT IS POSSIBLE THAT THE RESEARCHER, YOUR DOCTOR, AND YOU WILL NOT KNOW WHICH STUDY ARM YOU ARE AND WON'T BE ALLOWED TO FIND OUT AS LONG AS THE STUDY IS STILL GOING ON. IT IS IMPORTANT TO REMEMBER THAT UNLIKE MEDICAL STREEMENT, RESEARCH IS NOT DESIGNED TO SPECIFICALLY ADDRESS YOUR NEEDS AND INTERESTS AS AN INDIVIDUAL PATIENT. THE CARE THAT YOU RECEIVE IN A RESEARCH STUDY DOES NOT NECESSARILY PUT YOUR INDIVIDUAL INTERESTS FIRST, WILL NOT NECESSARILY BENEFIT YOU, AND COULD EVEN BE HARMFUL EVEN THOUGH THERE ARE PROTECTIONS IN PLACE. RESEARCH VOLUNTEERS CAN HELP SCIENCE ANSWER SPECIFIC MEDICAL OR BEHAVIORIAL QUESTIONS. RESEARCHERS HOPE THAT THESE ANSWERS WILL CONTRIBUTE TO A BETTER UNDERSTANDING OF HUMAN BIOLOGY AND BEHAVIOR AND LEAD TO MORE EFFECTIVE MEDICAL STREEMENTS IN THE FUTURE THIS VIDEO WAS DESIGNED TO ANSWER SOME BASIC QUESTIONS ABOUT RANDOMIZATION IN RESEARCH AND GIVE YOU SOME THINGS TO THINK ABOUT. DECIDING WHETHER TO PARTICIPATE IN RESEARCH CAN BE HARD. DON'T BE AFRAID TO ASK THE RESEARCH TEAM FOR MORE INFORMATION AND TALK WITH THEM ABOUT YOUR CONCERNS. IT'S THEIR JOB TO GIVE YOU THE INFORMATION YOU NEED SO YOU CAN MAKE THE MOST INFORMED DECISION ABOUT WHETHER TO PARTICIPATE. OHRP HAS CREATED A VARIETY OF RESOURCES TO HELP YOU THINK ABOUT RESEARCH PARTICIPATION, FOR MORE INFORMATION CHECK OUT OUR WEBSITE AT WWW.HHS.GOV/ABOUT-RESEARCH-PARTI CIPATION. >> SO THAT IS OUR LATEST VIDEO ON RANDOMIZATION, SO LIKE I SAID, YOU PROBABLY NOTICED THAT UNLIKE SOME VIDEOS OUTSIDE THAT TALK ABOUT THE SAME SUBJECT, WE TRY TO REALLY BE MORE DOWN TO EARTH ABOUT WHAT IT IS THAT IS INVOLVED. WE TRY--I'M TRYING TO FIND THE RIGHT WORD. WE TRY NOT TO EMBELLISH THE SITUATION AND WE WANT TO LEAVE IT OUT FOR POTENTIAL PARTICIPANTS TO THINK ABOUT THESE THINGS AND TO THINK ABOUT IT FOR THEMSELVES SO I THINK THIS IS REALLY WHAT WE ARE TRYING TO ACHIEVE IN DEVELOPING THE VIDEO ALSO, WE PUT A LOT OF ATTENTION INTO THINKING ABOUT WHAT WORDS TO USE AND HOW TO DWHREVER THAT INFORMATION IN A JUST MANNER. AND AS YOU ALL KNOW THIS, IS ALWAYS VERY DIFFICULT. SO I HOPE THAT WE ARE--WE HAVE BEEN ABLE TO ACHIEVE THAT. AND THESE ARE JUST SOME VERY BASIC DATA, THE RANDOMIZATION VIDEO IS JUST RELEASED, THE PROTECTING RESEARCH VOLUNTEERS PAGE THE INFO GRAPHICS. WE HAVEN'T RELEASED IT YET, WE THOUGHT WE WERE GOING TO PRIOR TOW THIS MEETING AND THEN THE OTHER 3 VIDEOS WE RELEASE THEM AT THE BEGINNING OF THIS YEAR AND OOTLE CURRENTLY--IT'S CURRENTLY LINKED TO FDA HAZARD PATIENT SITE. IT'S LINKED TO THAT, LINKED TO CLINICAL TRIALS.GOV. BUT WE REALLY WANT MORE PEOPLE TO KNOW ABOUT IT AND FROM OUR POINT OF VIEW AS I HAVE SAID, YOU KNOW, BECAUSE OUR ONLY ROLE AT OHRP IS TO HELP MAKE SURE THAT RESEARCH IS DONE IN AN ETHICAL MANNER AND THAT SUBJECTS ARE PROTECTED, SO THIS IS WHERE WE ARE COMING FROM. BY NO MEANS ARE WE TRYING TO, YOU KNOW MAKE RESEARCH MORE DIFFICULT, BUT I THINK THAT REALLY OUR GOAL IS TO MAKE PEOPLE UNDERSTAND CLEARLY WHAT'S GOING ON AND MAKE SOME DECISIONS FOR THEMSELVES. AND SO, YOU KNOW, I THINK MANY, MANY BIG INSTITUTION VS DEVELOPED SIMILAR SORT OF RESOURCES. OFTEN THEY DEVELOPED IT FROM THE PERSPECTIVE OF THINKING ABOUT RECRUITMENT AND SO ON. I THINK THAT THERE IS A SLIGHT DIFFERENT IN PERSPECTIVE SO I THINK THAT EVEN FOR THE INSTITUTIONS THAT MAY ALREADY HAVE THESE SORT OF RESOURCES, IT WILL BE USEFUL, I THINK TO LINK THEIR, WHATEVER THEIR RESOURCES ARE, ALSO TO THE OHRP REBECCA SITE SO THAT PEOPLE CAN GET A DIFFERENT PERSPECTIVE OR SLIGHTLY DIFFERENT PERSPECTIVES AS WELL. I THINK THAT'S WHERE--THAT'S ALL I WANT TO SAY AND I WANT TO THANK YOU VERY MUCH FOR OUR ATTENTION AND I WELCOME ANY COMMENTS YOU HAVE. CURRENTLY WE ARE THINKING ABOUT--WE'VE JUST STARTED TO THINK ABOUT A DIFFERENT PROJECT: IT'S A PROJECT ON USE OF DATA AND BY O SPECIMENS IN RESEARCH. AS YOU KNOW IT'S A VERY SENSITIVE TOPIC AND IT'S--WE NEED TO HANDLE IT AND YOU KNOW IN A JUST MANNER, SO WE ONLY--WE'VE ONLY JUST STARTED THINKING ABOUT IT. AND LIKE I SAID, YOU KNOW WE WELCOME ANY--ANY SUGGESTIONS THAT YOU MIGHT HAVE AND PLEASE, PLEASE, PLEASE, ALL OF YOU WHO ARE FROM INSTITUTIONS WHO WORK WITH IRB, DO TELL, YOU KNOW YOUR HRPP, YOUR INVESTIGATORS ABOUT THIS WEBSITE, DO ASK THEM TO LINK TO IT, SO THAT THAT GIVES OPPORTUNITY, ADDITIONAL SET OF RESOURCES FOR POTENTIAL RESEARCH PARTICIPANTS AND SO, WITH THAT, THANK YOU VERY MUCH AND I WELCOME ANY QUESTIONS AND COMMENTS. >> THANK YOU. QUESTIONS? >> MORE OF A COMMENT THAN A QUESTION. ONE OF THE THINGS THEY THINK PATIENTS AND THE GENERAL PUBLIC HAVE A LOT OF DIFFICULTY WITH IS PROBABILITY AND--YOU KNOW YOU DID A NICE JOB EXPLAINING THAT IT'S WHAT RANDOMIZATION IS, AND THAT STRESSING WHICH I THINK IS VERY IMPORTANT THAT YOUR DOCTOR WILL NOT BE CHOOSING THIS BASED ON YOUR HEALTH. THE ONLY CONCERN I HAD IS WHEN THE COIN FLIPS, PATIENTS ARE ALLOCATED AND THAT GOES ALONG WITH WHAT A LOT OF PATIENTS AND FAMILIES BELIEVE, THAT OH IF THE PERSON RANDOMIZED BEFORE ME GOT ARM A, THISSEN THIS IS A GOOD TIME TO JOIN'M I'M GOING TO GET--I'M GOING TO GET ARM B. AND I DON'T KNOW IF THERE'S AWAY TO ADDRESS THAT AND MAKE IT VERY CLEAR THAT THAT'S NOT HOW THIS WORKS. I JUST KNOW FROM COUNSELING PATIENTS AND WE SEE FAMILIES HAVE AIAN KID WITH KINETIC DISORDER AND THEN THE NEXT 1 HAS, IT'S THE 1 IN 4 SO WE THOUGHT WE WOULD--NYEAH,-- >> YEAH, WE WILL KEEP THAT IN MIND, TOO, YOU BROUGHT UP A VERY INTERESTING PROBABILITY AND LIKELIHOOD. THAT HAS BEEN AND WELL, STILL IS A TOPIC--CONVEY THAT INFORMATION SIMPLY. I MEAN, THE FACT THAT I--YOU KNOW I WORKED I WORKED IN MEDICINE AND I DID A LOT OF PATIENT COMMUNICATION, I THINK THAT I'M TRYING TO GO BACK IN THOSE DAYS AND THINK ABOUT, OKAY, REALLY WHAT EXACTLY DID PEOPLE-CONSENT PEOPLE WHAT IS THE SIMPLEST MESSAGE THAT WE CAN, YOU KNOW CONVEY WITHOUT GETTING THEM BOGGED DOWN BY ALL THE WEEDS OF IT IF YOU LIKE. SO I THINK THAT, YEAH, IT IS DEFINITELY ON OUR LIST OF THINGS THAT WE WANT TO HELP WITH, HOW TO COVER IT AND IN WHAT WAY. [INDISCERNIBLE]. >> WE'RE NOW SORT OF EMBRACING BEHAVIORIAL STUDIES AS CLINICAL TRIALS. BUT THIS HAS A VERY MEDICAL FOCUS. >> YES, I WOULD BE A LITTLE CONCERNED WITH SOMEONE WHO'S ABOUT TO PARTICIPATE IN A BEHAVIORIAL RESEARCH TRIAL. WATCHING THIS, BECAUSE IT DOESN'T SEEM TERRIBLY RELEVANT TO THEM, IT TELLS THEM THAT DOUBLE BLIND IS MUCH BETTER BUT DOUBLE BLIND IS VERY DIFFICULT AND UNUSUAL AND BEHAVIORIAL SO IT'S NOT QUITE TUNED TO THE DIRECTION THAT OHR OR THAT WE'RE GOING. I ALSO WONDER WHETHER ACTUALLY YOU'RE NOT TALKING ABOUT VALIDITY INSTEAD OF RELIABILITY IN THIS. >> ALL RIGHT, SO JUST THAT--SO JUST THAT WORD WHERE WE SAID, YOU KNOW IT'S MORE RELIABLE, WE SAT THERE WONDERING, OKAY, WHAT SIMPLE ENGLISH WORD. >> YEAH. >> SO YEAH, WE WENT THROUGH LIKE, ACCURACY, VALIDITY, BUT USE THESE--THE MOMENT WE START REALLY THINKING ABOUT, YOU KNOW MATHEMATICAL TERMS, ACCURATE SCIENTIFIC MATHEMATICAL TERMS, WE GO AWAY AND PEOPLE THINK WELL, THAT IS NOLT--WELL, YOU KNOW IT HAS BEEN A STRUGGLE, I DON'T KNOW. >> YEAH, I'M NOT SURE THAT RELIABILITY IS BETTER UNDERSTOOD THAN VALIDITY AND I THINK VALIDITY IS WHAT YOU'RE TALKING ABOUT. >> WE'RE NOT USING THE WORD RELIABILITY, LIKE MORE GENERAL, IS IT MORE RELIABLE. I THINK WE TRY TO KEEP IT AT A MORE GENERAL LEVEL. SO I THINK IF INVESTIGATORS ARE RESEARCHERS ARE GOING TO LOOK AT THIS AND SAY, WELL, BUT THAT'S NOT QUITE ACCURATE. YEAH, WE AGREE. I MEAN QUESTION IS HOW DO WE KEEP--PEOPLE--HAVE A LEVEL [INDISCERNIBLE] LEVEL 8 OR BELOW LEVEL, THAT STILL CONVEYS INFORMATION THAT IS-- >> I KNOW. >> --SUFFICIENTLY, YOU KNOW THAT PEOPLE GET IT. THE OTHER THING I WANT TO SAY IS THAT THESE ARE MORE BIOMEDICAL CENTERED. WE STARTED THINKING ABOUT THIS PROJECT LAST YEAR, AROUND--SO 2016 AROUND APRIL TIME, REASON IS BECAUSE WE HAVE THIS MIGRATION OF THE WEBSITE FROM THE OLD 1 TO A LOOK, SO THAT'S WHEN WE STARTED AND I THINK MAYBE WE REALLY SHOULD DO SOMETHING NOW. AND THEN BY JANUARY, BY FEDERAL GOVERNMENT'S STANDARD, THAT'S PRETTY PROMISING THAT WE WERE ABLE TO DEVELOP 53 VIDEOS AND OF COURSE, YOU KNOW LIKE I SAID, THIS IS AN ONGOING CONTINUOUS PROJECT. WE TACKLED SOME OF THE TOPICS THAT WE THINK ARE PROBABLY, IF YOU LIKE, MAYBE ASSOCIATED WITH MOST OF THE RISK THAT WE MIGHT SEE OR HAVE KIND OF A MORE COMPLICATED, IF YOU LIKE. YOU KNOW AND I THINK THAT'S WHY WE STARTED WITH THE CLINICAL RESEARCH. WE DEFINITELY UNDERSTAND IN THIS WORLD THERE'S A LOT OF SOCIAL BEHAVIORIAL RESEARCH AND SOMETIMES THEY HAVE DIFFERENT RISK LEVELINGS WELL. SO YES, WE WILL MOVE FORWARD AND THINK ABOUT THOSE AS WELL. BUT PLEASE GIVE US--PLEASE GIVE US SUGGESTIONS. >> ARE YOU INCORPORATING ANY COGNITIVE TESTING AS YOU DEVELOP THESE? ARE YOU SHOWING THEM-- >> I DON'T KNOW THAT WE WANT TO GO INTO TOO MUCH DETAILS ABOUT ACTUAL SCIENTIFIC INSTRUMENTS. >> NO, ARE YOU TESTING THEM AS YOU DEVELOP THEM? LIKE FOCUS GROUPS OR COGNITIVE-- >> NO, WE DON'T HAVE THE RESOURCES TO DO THAT, WE GET A LIMITED GROUP OF STAKEHOLDERS TO COMMENT ON IT BUT I THINK THAT THOSE OF YOU WHO WORKED IN THE GOVERNMENT, YOU KNOW THERE ARE LIMITATIONS. >> WE HOPE, ACTUALLY, WE HOPE THAT-- >> THAT IS A SHAME THOUGH. THAT'S A MISSED OPPORTUNITY, I THINK. >> BUT YOU KNOW WHAT? WE HOPE THAT PEOPLE WILL PICK THIS UP AND ACTUALLY DO SOME STUDY TO SEE IF IT ACTUALLY MAKES A DIFFERENCE. I MEAN, THIS WAS HOW IT ACTUALLY--THIS IDEA WAS HOW IT ACTUALLY GOT STARTED. YOU KNOW IT WOULDN'T MAKE ANY DIFFERENCE, YOU KNOW? PEOPLE SHOULD PROMOTIONAL GO ABOUT AND CONSIDER STUDYING AND-- >> SO WE OFTEN READ ABOUT THE COIN TOSS AND INFORMED CONSENTS. YOU KNOW WHY NOT INCLUDE SOMETHING THAT ACTUALLY INSTRUCTS HOW IT'S DONE? >> YES, YES. SO IF YOU NOTICE IN THE INFO GRAPHICS WE HAVE SLIDES THAT START TALKING ABOUT THE REGULATIONS, WE MENTION WORDS TERMS LIKE INSTITUTION REVIEW BOARDS, INFORMED CONSENT, THAT KIND OF THING. WE HAVE ALREADY, WE THINK THAT THAT MIGHT BE A PLATFORM TO TAKE IT TO SPRP ELSE. SO--SOMEWHERE ELSE. SO EVERYTHING WE DO NOW ARE LIKE BUILDING BLOCKS HOPING TO, YOU KNOW THINGS WILL SPINOFF FROM THEM AND DEFINITELY, YES, WE HAVE THOUGHTS ABOUT DOING SOMETHING WITH INFORMED CONSENT AND THEN WE WERE LOOKING THROUGH OUR ARCHIVES AND WE FISHED OUT THIS OLD VHS THAT WAS DONE WAY BACK WHEN, YOU KNOW O RP WAS OHRP AND BACK IN THE AGE AND IT WAS 3 PARTS VIDEO THAT WAS DONE BY THE NATIONAL LIBRARY OF MEDICINE FEATURING PELLIGRINO, EXPLAINING ABOUT THE ROW OF INSTITUTION REVIEW BOARDS AND YOU KNOW HOW THAT IS DONE AND YOU KNOW IN SPITE OF THE PICTURE BEING KIND OF OLD, IF YOU LIKE, IT WAS REALLY, REALLY WELL DONE BEING PELLIGRINO, YOU KNOW HE WAS ABLE TO FIEBD OUT WHAT PEOPLE NEED TO LOOK AT AND THINK ABOUT. TALKING ABOUT INFORMED CONSENT [INDISCERNIBLE]--WHY IT'S IMPORTANT IN A WAY THAT IS VERY SENSIBLE IF YOU LIKE, VERY, VERY INFORMATIVE. SO, WE [INDISCERNIBLE] WE RESUSCITATED THAT VIDEO AND WE DIGITIZED IT AND WE HAVE TO PUT CASH IN IT AND THINGS LIKE THAT. SO FROM THE INFO IMRAF GRAPHICKINGS THAT WOULD BE A LINK THAT COULD TAKE PEOPLE TO UNDERSTANDING THAT PART AND OF COURSE, OVERTIME DEPENDING ON RESOURCES AND INTERESTS, WE WILL TRY TO DEVELOP ALSO COMPLEMENT WHETHER IT BE INFORMED CONSENT OR IRBs OR OTHER THINGS. >> EXCUSE ME, I WAS REFERRING TO THE RANDOMIZATION PROCESS, JUST HAVING THE LINK QUICKLY EXPLAIN, THERE ISN'T SOMEBODY IN THE BACK ROOM TOSSING COINS. OH, OH, OKAY. >> I ALSO LOOKED THROUGH THE OTHER VIDEOS, AND SOME THINGS CAME TO JUST STOOD OUT. IN WHAT IS RESEARCH, YOU HAVE WAYS TO IMPROVE EDUCATIONAL PROGRAMS AND I REALIZE YOU WILL NOT MAKE ANY CHANGES AT THIS POINT BUT I DON'T THINK A LOT OF PATIENTS APPRECIATE THE AMOUNT OF TRAINING OF DOCTORS AND SCIENTISTS THAT GOES ON, AND GOES ON THERE AND THAT IMPROVING EDUCATIONAL PROGRAMS TO ME, IS SO VAGUE. IT DOESN'T REALLY POINT TO TRAINING YOUNG DOCTORS OR NEW DOCTORS OR NEW SCIENTISTS. AND THEN IN CLINICAL TRIALS, YOU MENTION USE BLOOD TAKEN FOR OTHER CARE AND THAT'S SOMETHING--I MEAN I NEVER SEE, RIGHT? IN CLINICAL TRIALS THAT ASK FOR BLOOD ON A SCHEDULE, IT'S NOT BLOOD THAT USED FOR OTHER CARE SO I WAS REALLY SURPRISED WHERE YOU PUT THAT IN. I CAN'T REMEMBER EXACTLY WHAT'S IN THE SCRIPT BUT WE WILL GO BACK AND LOOK AT IT. ACTUALLY WE WELCOME ANY OF THIS IF YOU WANT TO JUST POINT IT OUT AND WE'LL HAVE A LOOK. --I THINK IT'S VERY APPROPRIATE ON THE OHRP WEBSITE. I WOULD LIKE YOU TO THINK ABOUT A PLACE HOLDER FOR THE FUTURE ABOUT THE VIDEO OF IRBs, SO EVEN IN THE SUBTEXT OF RANDOMIZATION, I THINK IT NEEDS TO BE SAID THAT SOMEONE HAS LOOKED AT THESE 2 ARMS AND SEEN THE RISK AND BENEFIT AND SUCH AND NO 1 KNOWS ABOUT IRBS. SO I THINK THAT WOULD BE VERY USEFUL TO THE PUBLIC. AND THEN THE OTHER QUESTION IS WHETHER WE CAN USE THOSE 21 OR 30 QUESTIONS IN THE PRIPTED LIST AS A GUIDE TO THE PRECISE SUMMARY,. >> IT DOES COVER ALL THE ELEMENTS, I HAVE TO SAY. >> THIS IS GREAT, OBVIOUS 3 THERE ARE ALL--THERE ARE MANY--YOU'VE TEASED US A BIT AND THERE'S SO MUCH WE WOULD LOVE TO SEE HERE BUT THIS A WONDERFUL BEGINNING. >> THANK YOU VERY MUCH, YES,. >> I APPLAUD YOUR EFFORTS AS WELL AND HOPE YOU BUILD ON. >> WE DEFINITELY WILL, WE HAVE GREAT ASPIRATION FOR THIS PROJECT. WE REALLY THINK THAT WE HAVE A RESPONSIBLE AND I THINK WE ARE REALLY IN A UNIQUE POSITION TO TRY TO PROVIDE INFORMATION BUT AS YOU ALL KNOW IT'S--IT'S NOT A SIMPLE STRAIGHT FORWARD AND I THINK THAT WE'RE TRY TO BALANCE IT OUT AS MUCH AS POSSIBLE SO THAT THE INFORMATION IS VALUABLE . >> I ALSO THINK IT'S REALLY GOOD AND I AM THINKING OF MY 8 YEAR-OLD,LY WOULD GET IT. IT'S VERY CLEAR BUT IT'S NOT DUMBED DOWN. AND I APPLAUD YOUR EFFORTS. I HAVE TO 2 SUGGESTIONS FOR WHAT MIGHT BE HELPFUL VIDEO BUT WOULD BE CHALLENGING. ONE ON EQUIPOISE, IT WOULD BE HELPFUL BUT FITS INTO THE RANDOMIZATION, AND IT MIGHT BE IN THE--RESEARCH MODULE WITH THAT 1--SNRNTION YES,-- >> YES, YES, YES. >> BUT TO HELP PEOPLE UNDERSTAND THAT WE DON'T REALLY KNOW THE ANSWER TO THE QUESTION, WHICH IS WHY IT'S OKAY TO RANDOMIZE YOU, AND I NOTICED IN THE VIDEO YOU JUST SHOWED THERE WAS AN EQUATION THAT RESEARCH IS NOT THE SAME AS CLINICAL CARE. IT IS SOMETHING I HAVE IN MY OWN SLIDES WHEN I PRESENT ON THESE THINGS AND YEAH, EDUCATIONAL SETTINGS, BUT I STARTED TO TAKE IT OUT BECAUSE OF THE MOVE TO LEARNING HEALTH SYSTEMS AND THE BLURRING OF THE LINES BETWEEN RESEARCH AND CLINICAL CARE, SO THAT MIGHT BE SOMETHING THAT YOU COULD WORK INTO THE DATA AND SPECIMENS TOPIC ALTHOUGH THAT'S OBVIOUSLY REALLY RICH IN AND OF ITSELF BUT JUST TO HELP PEOPLE UNDERSTAND THAT IT MIGHT BE HELPFUL OR IMPORTANT TO USE THEIR CLINICAL DATA FOR RESEARCH PURPOSES AND THAT THE LINE IS A LITTLE BIT BLURRY BUT IT'S MORE COMPLICATED TOPIC. >> YES AND I THINK WE WILL ALL PROMOTIONAL DO A BIT MORE OF THAT, TOO WHEN WE START TACKLING THIS BUSINESS ABOUT USING PEOPLE'S DATA AND BIOSPECIMENS FOR RESEARCH. YEAH. >> THANK YOU. THANK YOU FOR MENTIONING THAT HOLLY BECAUSE IT STOOD OUT FOR ME AS WELL ESPECIALLY IN CANCER CLINICAL TRIALS WHEN SO MUCH EFFORT IS MADE TO HAVE BOTH ARMS GET STANDARD OF CARE PLUS OR MINUS THE INVESTIGATIONAL AGENT, RIGHT? SO EVERYBODY REALLY IS GETTING WHAT STANDARD CARE IS. AND ALSO, INTRODUCING, THAT TERM, STANDARD OF CARE BECAUSE YOU HAVE A FEW WAYS OF APPROACHING. YOU HAVE NEW DRUG AND THE NEW DRUG AND THE INVESTIGATIONAL DRUG ARE BOTH RED AND WHITE CAPSULES. THEY LOOK THE SAME,. >> OKAY, OKAY. >> ALL RIGHT, SO, THANK YOU. I THINK WE COULD GO ON WITH--IT'S GREAT. REALLY. BUT WE HAVE TO MOVE ON. TO OUR SECOND TOPIC. AS SOON AS OUR SPEAKER IS READY. >> SO MARK BARNES, THE HIPAA EXEMPTION FOR THE SUBCOMMITTEE ON HARMONIZATION. >> GOOD MORNING EVERYBODY. SO WE HAVE A--WE HAVE A RIVETTING TOPIC OF THE HIPAA EXEMPTION TO DISCUSS TODAY. THE MARISSA GORDON WIN IS HERE FROM OCR AND IF AT ANY POINT MARISSA, IF YOU WANT TO COME SIT UP HERE, YOU'RE WELCOME TO SIT UP BECAUSE THERE MAY BE QUESTIONS THAT YOU WILL BE WELL POISED TO ANSWER SO ... SO THE SUBCOMMITTEE DID NOT COME UP WITH THIS PROJECT ON ITS OWN, THE SUBCOMMITTEE WAS ASKED BY OHRP TO LOOK AT THE HIPAA EXEMPTION IN THE SAME WAY WE WERE ASKED TO LOOK AT BROAD CONSENT, ALTHOUGH PLEASE, I HOPE THIS IS LESS CONTROVERSIAL THAN THE BROAD CONSENT. THE--WE WERE ASKED TO LOOK AT HIPAA EXEMPTION AND I'LL DESCRIBE WHAT IT IS IN A MOMENT AND TRY TOIDENTIFY PROBLEMS THAT MIGHT EXIST IN INTERPRETING THE PROVISION FOR A NEW SO CALLED HIPAA EXEMPTION AND THEN MAKE RECOMMENDATIONS THAT SACHRP COULD ADOPT, IGNORE OR CHANGE AND MAKE ON TO THE HHS SECRETARY IN REGARD TO HOW BEST TO INTERPRET THE HIPAA EXEMPTION. AND THERE ARE SOME REAL AMBIGUITIES IN THE HIPAA EXEMPTION AS YOU'LL SEE. WE TRIED TO--WE SPENT A GOOD DEAL OF TIME ON THIS. WE HAVE A GUIDANCE DOCUMENT WHICH IS IN DRAFT FORM THAT IS AVAILABLE TO YOU, IT WAS SENT AS PART OF THE MEETING MATERIALS, AND IS ALSO AVAILABLE OUTSIDE IN PRINTED COPY WHICH IS SOMEWHAT LENGTHY. I'M GOING TO--I HAVE A POWER POINT IN WHAT I'M GOING TO DO IS GO THROUGH THE ISSUES, THEMEATICALLY WITH YOU SO THAT I CAN--USING THE POWER POINT TO EXPLAIN WHAT WE'VE DONE, WHAT WE'VE RECOMMENDED AND WHY. SO JUST A COUPLE OF WORDS OF BACKGROUND HERE. HIPAA IS--WHEN IT FIRST CAME INTO EFFECT IN 2001-2002, MANY OF US REALIZED THAT IN RESEARCH WITH HUMANS THAT WE WOULD HAVE TO IN OUR COVEREDDENTITY INSTITUTIONS WHICH ARE LARGELY BUT FOR THESE PURPOSES NOT ENTIRELY HEALTHCARE PROVIDERS ALSO INCLUDES HEALTH PLANS AND SUBSTANCE ABUSE AGENCIES AND TREATMENTS AND OTHERS THAT DO 1 MORE MORE ELECTRONIC REIMBURSEMENT TRANSACTIONS, WE REALIZE WE WOULD HAVE TO COMMRI NOT ONLY--COMPLY NOT ONLY WITH THE COMMON RULE FOR FEDERALLY FUNDED RESEARCH BUT WOULD HAVE TO COMPLY WITH HIPAA AND SO THERE WERE MANY--THERE WAS MUCH COMMENTARY AT THE TIME. NIH HAS SPECIFIC COMMENTARY THAT'S PUBLISHED ON ITS WEBSITE IN REGARD TO HOW TO APPLY HIPAA TO AND READ THE HIPAA REQUIREMENTS ALONG WITH THE COMMON RULE REQUIREMENTS. OCR HAS MANY FAQs AND PUT OUT GUIDANCE ITSELF ON HOW TO APPLY HIPAA IN THE CONTEXT OF RESEARCH WITH LIVING HUMAN BEINGS AND THE--SO WHAT IS SOMEWHAT ODD ABOUT THIS EXEMPTION IS REALLY THE FOLLOWING AND LET ME JUST START WITH THIS, WHICH IS THAT THIS IS AN EXEMPTION UNDER THE REVISED COMMON RULE. IT IS NOT AN EXEMPTION UNDER HIPAA. SO EVEN IF THE RESEARCH THAT YOU'RE GOING TO DISCUSS TODAY, THE CATEGORY OF RESEARCH FITS UNDER THE COMMON RULES, HIPAA EXEMPTION THAT IS AN EXEMPTION FROM THE COMMON RULE, IT IS NOT AN EXEMPTION FROM HIPAA. JUST TO BE CLEAR ABOUT THIS. I THINK THERE COULD EASILY BE CONFUSION GIVEN THE TERMINOLOGY IS THE HIPAA EXEMPTON WHICH SOUNDS AS THOUGH IT'S AN EXEMPTION FROM HIPAA WHEN IT'S NOT. SO WITH THAT, LET ME--LET ME GO INTO--INTO THE POWER POINT. THIS IS THE--ACTUAL TEXT OF THE REVISED COMMON RULE THAT WE ARE DISCUSSING TODAY AND LET ME JUST--BEAR WITH ME WHILE I READ IT FOR THOSE WHO ARE ON THE SIMULCAST. THIS IS SECONDAR RESEARCH FOR WHICH CONSENT IS NOT REQUIRED. SECONDARY RESEARCH USES OF IDENTIFIABLE PRIVATE INFORMATION OR IDENTIFIABLE BIOSPECIMENS IF AT LEAST 1 OF THE FOLLOWING CRITERIA IS MET. AND THEN THERE ARE 4 DIFFERENT POSSIBILITIES HERE. WE ARE FOCUSED ON THE THIRD 1. THE THIRD 1 IS THIS: SECONDARY--JUST TO GO BACK TO SQUARE 1. SECONDARY RESEARCH USES OF IDENT FIELD FIELD FUNCTIONSABLE PRIVATE INFORMATION OR IDENTIFIABLE BIOSPECIMENS IF AT LEAST 1 OF THE COLLECTION COLLECTION OF ANALYSIS INVOLVING INVESTIGATOR'S USE OF IDENTIFIABLE INFORMATION WHEN THAT USE IS REGULATED UNDER THE HIPAA PRIVACY RULE FOR THE PURPOSES OF HELT CARE OPERATIONS OR RESEARCH AS THOSE TERMS ARE DEFINED IN HIPAA OR PUBLIC HEALTH ACTIVITIES AS DEFINED IN HIPAA. SO THIS IS THE--THIS IS WAWE HAVE TO INTERPRET. NOW WHERE DID THIS COME FROM? THE IDEA IN THE PREAMBLE TO THE--IN THE COMMENTARY, IN THE FINAL RULE, BASICALLY SAYS THAT WHEN RESEARCH WITH HUMANS IS SUBJECT BOTH TO HIPAA AND TO THE COMMON RULE AND INVOLVES SECONDARY USE OF IDENTIFIABLE DATA, SO THESE ARE DATA THAT WERE ALREADY COLLECTED, THERE WERE NO PROTECTIVE RESEARCH INTERVENTIONS WITH THESE INDIVIDUALS, SECONDARY USE OF ALREADY COLLECTED DATA, IDENTIFIABLE DATA WHEN THAT EXISTS THE PRIMARY RISK TO THE INDIVIDUALS IS 1 OF VIOLATION OF PRIVACY. THE REASONING GOES, I HAPPEN TO AGREE WITH IT BUT YOU DON'T HAVE TOO BECAUSE HIPAA, IS A VERY STRONG AND RIGOROUS AND ROBUST PROTECTION FOR IDENTIFIABLE DATA, SO THAT THOSE DATA CANNOT BE MISRUESED OR DISCLOSED TO OTHERS WHO DON'T HAVE A RIGHT TO HAVE ACCESS TO THEM, AND TO USE THOSE DATA, BECAUSE HIPAA EXISTS, IT IS ADEQUATE TO PROTECT THE PRIVACY RIGHTS OF INDIVIDUALS, SO THAT THERE IS NO REASON TO REQUIRE SIMULTANEOUS JURISDICTION BY THE COMMON RULE AND ULTIMATELY BY REVIEW AND APPROVAL USUALLY USING WAIVER OF CONSENT BY AN IRB. THAT'S THE THEORY. OKAY? AND IT IS TRUE AND I DON'T MEAN TO SAY THAT SKEPTICALLY, IT IS TRUE, THE COMMON RULE IS BASICALLY HAS ADMINISTRATIVE POTENTIAL SANCTIONS AND THAT IS UMENT MATILY HHS CAN REVOKE FUNDING, CAN HHS CAN BAR SOMEONE FROM GETTING FUTURE FUNDING FOR HUMAN SUBJECT RESEARCH ACTIVITIES IF THEY--IF THE INSTITUTION AND INDIVIDUALS ENGAGE INDEED GROSS VIOLATIONS OF THE COMMON RULE. IN HIPAA EXEMPTIONA IT IS MUCH MORE ROBUST IN TERMS OF THE SANCTIONS THAT ARE POSSIBLE. MARIRKS - ISSA COULD TELL YOU ABOUT IT IS - POSSIBLE TO SPEND TIME IN THE FEDERAL PENITENTIARY FOR VIOLATING HIPAA AND THE THEOR SETHAT HIPAA IS ACTUALLY NOT ONLY AS PROTECTIVE AS THE COMMON RULE IN THESE WAYINGS IT'S MORE PROTECTIVE IN THESE QUALIFIER AND WAYS. SO I'M GOING TO NOW GO INTO THE AMBIGUITYS BUT MARISSA, DO YOU WANT TO ADD ANYTHING TO THAT? >> NO I THINK THAT'S A FAIR INTRODUCTION. JUST TO TO NOTE THAT MY AGENCY, HHS, ENFORCES CIVIL PENALTIES FOR VIOLATIONS AND THERE ARE CRIMINAL PENALTIES HOWEVER, WHICH ARE HEARD ABOUT LESS OFTEN BUT THAT'S ENFORCED BY THE DEPARTMENT OF JUSTICE. >> OKAY, SO TO PROCEED. THIS IS THE COMMENTARY THAT IS THE RELEVANT COMMENTARY IN THE PREAMBLE TO THE JANUARY 19th 2017 REVISION AND IT BASICALLY SAYS WHAT I--THIS IS THE TEXT OF WHAT I JUST SUMMARIZED FOR YOU CONCEPTUALLY. , THESE ARE THE ISSUES THAT WE IDENTIFIED AND I WILL TAKE YOU THROUGH EACH OF THE ISSUES AND EXPLAIN WHAT THE ISSUE IS AND EXPLAIN WHAT WE RECOMMENDED AND WHY. WHAT I WOULD SUGGEST STEPHEN IF THIS IS OKAY WITH YOU, IS THAT I WILL PRESENT EACH OTHER ISSUE AND IF THERE ARE QUESTIONS ABOUT THAT ISSUE, LET'S STOP THERE AND TAKE THE QUESTIONS RATHER THAN WAITING UNTIL THE END OTHERWISE YOU WILL BECOME TERRIBLY CONFUSED, OKAY? AS WILL I. THESE ARE THE ISSUES. WHEN IS THIS HIPAA EXEMPTION AVAILABLE FOR COLLABORATIVE RESEARCH, THAT IS RESEARCH INVOLVING 2 SEPARATE RESEARCH TEAMS IN 2 SEPARATE HIPAA COVERED ENTITIES LIKE 2 HOSPITAL SYSTEMS FOR EXAMPLE TO TAKE THE EASIEST EXAMPLE. REMEMBER THE HIPAA EXEMPTION IS ONLY AVAILABLE TO RESEARCHERS WHO ARE WORKING WITHIN INSTITUTIONS THAT ARE COVERED ENTITIES UNDER HIPAA. SO JUST REMEMBER THAT SO MANY SOCIAL SERVICE SETTINGS ARE NOT SETTINGS THAT ARE--THEY'RE NOT EN--STRATEGIES--INSTITUTIONS THAT ARE COVERED ENTITIES UNDER HIPAA SO THIS IS PRIMARILY BIOMEDICAL IN ITS ISSUE MPLET SO THE SECOND CONSIDERATION IS BUSINESS ASSOCIATES UNDER THE ASSOCIATION. WHEN A COVERED ENTITY IS ASKING A NONCOVERRED ENTITY TO DO FUNCTIONS TO ASSIST IN FUNCTIONS, THAT FALL UNDER THE CATEGORIES OF TREATMENT PAYMENT HEALTHCARE OPERATIONS AND THE ENTITY ASSISTING IS NOT A COVERED ENTITY UNDER HIPAA, IT IS REQUIRED TO BE BOUND BY A BUSINESS ASSOCIATE AGREEMENT SO THAT BY IMPLICATIONS, BY CONTRACT, THE JURISDICTION OF HIPAA EXTENDS TO THE NONCOVERRED ENTITY SO THAT THE DATA, THE PROTEBLGHTED HEALTH INFORMATION IS STILL PROTECTED WHEN THE--WHEN THE INTEX ORGANIZATION COVEREDDENTITY SHARES WITH THE NONCOVERREDDENTITY. SO THE QUESTION IS, HOW DO BUSINESS ASSOCIATES WORK. DOES THAT--DO THEY ENJOY THE HIPAA EXEMPTION, TOO FOR THE KINDS OF THINGS, THE KINDS OF RESEARCH THAT THEY MAY WANT TO DO EITHER IN INDEPENDENTLY OR IN COLLABORATION WITH THE COVERED ENTITY THAT GAVE THEM THE BOUND--THAT BOUND THEM BY THE BUSINESS ASSOCIATE AGREEMENT. THE THIRD ISSUE IS WHETHER THE HIPAA EXEMPTION APPLIES TO THE DATA OR WHETHER IT APPLIES TO IDENTIFIABLE BIOSPECIMENS TO ALLOW THE DOWN STREAM USE WITHIN COVERED ENTITIES WITH IDENTIFIABLE BIOSPECIMENS, THAT'S THE QUESTION. FOUR IS WHAT ABOUT INFORMATION IDENTIFIABLE INFORMATION THAT IS ADDED TO A REG SPHREE OR--REGISTRY OR DATABASE OR ADDED TO THE DATA AFTER THE INITIAL SECONDARY RESEARCH USE UNDER THIS EXEMPTION. THAT IS WHEN YOU HAVE A COHORT OF PATIENTS THAT'S MOVING THROUGH TIME, YOU MAY APPLY THE HIPAA--AS A RESEARCHER, YOU MAY SEEK AND APPLY AND GAIN USE OF THE EXEMPTION AT POINT X BUT WHAT ABOUT X+ 1 YEAR. CAN YOU THEN GO BACK AND COLLECT THE DATA BETWEEN X AND X+ 1 YEAR AND ADD THOSE DATA WHEN THOSE DATA WERE CAPTURED OR OBTAINED NOT BECAUSE OF ANY RESEARCH INTERVENTION THAT YOU DID. THESE WERE DATA THAT WERE GOING TO BE CAPTURED ANYWAY. SO THAT'S THE QUESTION, IS THE TEMPORAL ELEMENT HERE AND HOW IT APPLIES. THE FIFTH IS TO UNDERSTAND WHY IT IS THAT THIS EXEMPTION AND LET ME JUST GO BACK TO THE LANGUAGE OF THE EXEMPTION, WHY DOES THIS EXEMPTION REFERENCE HEALTHCARE OPERATIONS AND PUBLIC HEALTH ACTIVITIES WHEN RESEARCH AS A DEFINED TERM UNDER BOTH THE HIPAA PRIVACY RULE AND THE COMMON RULE, IT IS WORD FOR WORD THE SAME. THIS IS SOMETHING THAT PUZZLED US, WE HAVE A RESOLUTION TO IT BUT IT WAS A QUESTION THAT WE CERTAINLY RAISED. THE SIXTH IS WHETHER 1 CAN USE THIS EXEMPTION IN COMBINATION WITH OTHER EXEMPTIONS IN ORDER TO COMBINE DATA AND USE THOSE DATA TOGETHER IN A RESEARCH STUDY. AND 7 IS HOW OTHER LEGAL REQUIREMENTS INTERSECT WITH THIS AND WHEN WE MEAN OTHER LEGAL REQUIREMENTS, I MEAN LET'S LIST THEM OUT. REMEMBER THAT HIPAA ITSELF BECAUSE WE'RE TALKING ABOUTA ENTHUSIASM IRTS THAT ARE COVERED ENTHUSIASMILITYS UNDER HIPAA. SO HIPAA WILL APPLY TO ALL THE DATA, THE PHI, THE IDENTIFIABLE HEALTH DATA THAT WE'RE ABOUT TO DISCUSS. WHAT IS THAT THING GOING OFF? [LAUGHTER] OKAY, I DIDN'T KNOW WHAT IT WAS. OKAY. I THOUGHT JERRY WAS TELLING ME TO BE QUIET. [LAUGHTER] SO, HERE'S THE QUESTION, AND SO THE COMMON RULE WOULD NOT APPLY. HIPAA WOULD ARKTS PLIE. BUT WHAT ABOUT ALL THE OTHER LAWS OUT THERE, ABOUT GENETIC TESTING AND THE USE AND DISCLOSURE OF GENETIC INFORMATION, USE AND DISCLOSURE OF TUBERCULOSIS INFORMATION, SUBSTANCE AND ABUSE AND TREATMENT REGULATION AND ALL OF THESE MAY APPLY TO THESE DATA. YOU DON'T GET EXEMPTED FROM THOSE THINGS JUST BECAUSE THERE'S ACCESS TO THE SO CALLED HIPAA EXEMPTION. SO HOW DOES ALL THAT WORK TOGETHER. SO THESE ARE THE QUESTIONS THAT WE IDENTIFIED. SO I'M GOING TO TAKE THEM 1 AT A TIME AND I ALSO HAVE SOME HANDY GRAPHICS TO EXPLAIN SOME OF THIS TOO YOU. WHICH I HAVE TO SAY, I WAS--I'M A COMPLETE--COMPLETELY INEPT AT GRAPHICS BUT A YOUNG MAN WHO WORKS WITH ME [INDISCERNIBLE] GRACIOUSLY DID THESE GRAPHICS FOR US SO YOU WILL APPRECIATE THEM WHEN THEY COME UP. THEY ARE QUITE ANIMATED. ANYWAY, SO HERE IS THE--HERE'S THE PROBLEM AND THEN WE'LL GO INTO THE HOW PERHAPS TO SOLVE IT. THE HIPAA EXEMPTION IS BY ITS TERM SYSTEM AN EXEMPTION THAT APPLIES TO 1 RESEARCHER OR TEAM OF RESEARCHERS WITHIN 1 COVERED ENTITY THE. THERE'S A DIFFERENCE IN HIPAA BETWEEN THE TERM DISCLOSURE AND THE TERM USE. IF YOU WILL LOOK AT THE BACK OF THE TEXT OF THIS. IT SAYS WHEN THE USE IS REGULATED. NOT THE DISCLOSURE, IT SAYS THE USE. NOW WHAT'S THE DIFFERENCE BETWEEN THE USE AND A DISCLOSURE? A DISCLOSURE IS--IS THE SENDING OF PROTECTED HEALTH INFORMATION OUTSIDE OF THE COVERED EPTITY THAT HAS IT--ENTITY THAT HAS IT. TO ANOTHER PERSON WHO IS OUTSIDE NOTOT WORKFORCE OF THAT PARTICULAR COVERED ENTITY. THAT'S A DISCLOSE. SO FOR 1 HOSPITAL TO SEND INFORMATION TO ANOTHER HOSPITAL OR TO A UNIVERSITY RESEARCHER OR TO THE RANDOMIZED TRIAL CORPORATION ALL OF THAT IS A DISCLOSURE. IF IT'S A COVER ENTITY THAT HAS PHI, THE USEOT OTHER HAND IS WHAT THE COVERED ENTITY DOES WITH THE INFORMATION NOT BY DISCLOSING IT OUTSIDE BUT BY USING THE INFORMATION INSIDE. AND REMEMBER THE USE IS ONLY PERMITTED BY A COVERED ENTITY IT HAS TO TREAT PATIENTS AND DO ITS OWN HEALTHCARE OPERATING GLOBALLY RAIGDZS LIKE QUALITY ASSURANCE AND TO BUILD 30 PARTY PAYORS, THAT'S WHRA IT'S ALLOWED TO DO AND SOME CASES IT'S ALLOWED TO DO OTHER THINGS BY LAW REPORT DISEASES BY NAME, THOSE ARE OTHER EXEMPTIONS. BUT A USE IS WHAT HAPPENED WITHIN A COVERED ENTITY, DISCLOSE SURA PHI OUTSIDE OF A COVERED ENTITY. OKAY, SO,--SO THIS--LET ME GIVE YOU THE GRAPHIC HERE. SO LET'S SAY THAT WE HAVE 2 COVERED ENTITIES, FOR THIS PURPOSE WE WILL CALL THEM MERCY HOSPITAL. DOES THIS POINTER WORK SESEALIA? >> IT DOES. OKAY. SO WE HAVE 2 COVERED ENTITIES IN THIS HYPOTHETICAL, MERCY HOSPITAL, MERCY BEING OF ALL RELIGIONS IT WAS ACTUALLY A- RELIGIOUS TO USE THAT AND NORTHERN MEDICAL CENTER. BOTH OF THEM CONTAIN PHI THAT THE RESEARCHERS WOULD LIKE TO USE AND THE 2--AND THE 2 RESEARCH TEAMS, 1 WITHIN NORTHERN MEDICAL AND 1 WITH MERCY HOSPITAL WOULD LIKE TO BE ABLE ON COMBINE THEIR DATA AND THEY WOULD LIKE TO BE ABLE TO DO THE RESEARCH WITH THEIR COMBINED DATA SET.& I'M GIVING YOU A SIMPLE HYPOTHETICAL, MORE LIKELY IN DAY AND AGE OF BIG DATA AND REAL WORLD EVIDENCE WE'RE LOOKING AT 15,000 HEALTHCARE PROVIDERS, POTENTIALLY COMBINING THEIR DATA OR SOMETHING LIKE THAT. OKAY. SO WHEN THEY WANT TO--THEY INVESTIGATORS ARE WITHIN THESE 2 ORGANIZATIONS AND REMEMBER WHEN THEY WANT TO USE THE INFORMATION THE PHI FOR RESEARCH THEY HAVE ACCESS UNDER THE COMMON RULE TO THE EXEMPTION TO THE SO CALLED HIPAA XENCHES BUT THEY STILL NEED TO COMPLY WITH HIPAA SO IN ORDER TO USE THOSE DATA FOR THOSE PHI FOR THEIR OWN RESEARCH PROJECT IN THIS CASE WITH MERCY HOSPITAL, FORGET ABOUT NORTHERN FOR A SECOND, THIS INVESTIGATOR HAS TO APLOY TO HIS OR HER IRB OR PRIVACY BOARD FOR A WAIVER OF HIPAA AUTHORIZATION TO ALLOW HIM OR HER TO USE THE DATA FOR THE RESEARCH. SO THEY'VE ALREADY GOT TO GO TO AN IRB OR PRIVACY BOARD IN ORDER TO GET A WAIVER OF AUTHORIZATION THAT'S THE PROCESS THEY HAVE TO GO THROUGH AND THEN THEY HAVE TO MEET THE REQUIREMENTS FOR A WAIVER OF AUTHORIZATION, WHICH ESSENTIALLY IS THAT THE USE OF DATA WOULD BE MINIMAL RISK TO THE INDIVIDUALS. IT'S MORE COMPLICATED THAN THAT BUT THAT'S THE BOTTOM--THAT'S REALLY THE SIMPLIFICATION OF IT SO THIS GUY OR WOMAN OVER HERE HAS ALREADY GOT TO GO TO THE PRIVACY BOARD FORGETTING ABOUT ANY OTHER COVERED ENTITY BEING INVOLVED. OKAY? AND USE UNDER THE COMMON RULE SO THEY WOULD NOT HAVE TO GO OUT OF THE IRB AND APPLY WITH A FULL RESEARCH PROTOCOL AND ASK FOR A WAIVER OF CONSENT. THEN IF NORTHERN WANTS TO USE THE INFORMATION, THE PHI FOR ITS OWN RESEARCH PROJECT, IT WOULD ALSO HAVE TO GO TO ITS IRB OR CENTRAL PRIVACY BOARD IN ORDER TO GET THE SAME THING AND THEN IT WOULD HAVE ACCESS TO THE EXEMPTION FOR ITS OWN DATA, IT'S OWN RESEARCHERS COULD USE ITS OWN DATA WITHOUT HAVING TO GO TO AN IRB AND SEEKING WAIVER OF CONSENT AND APPROVAL OF THE PROTOCOL UNDER THE COMMON RULE. NOW HOW DO WE--IF THESE 2 INVESTIGATORS HAVE SIMILAR RESEARCH INTERESTS AND WANT TO COMBINE THE DATA SETS THOUGH, HOW DO WE EFFECT THE SHARING OF PHI FOR COLLABORATIVE RESEARCH BETWEEN THE 2 ENTITIES, THE 2 COVERED ENTHUSIASM IRTS BECAUSE THE--ENTHUSIASM RITS BECAUSE THE EXEMPTION BY ITS TERMS ONLY TALKS ABOUT USE, NOT ABOUT DISCLOSURE. AND WE'VE STILL GOT TO OBEY HIPAA. SO HOW DO WE DO THIS? WELL, THE WAY WE DO THIS IS, WE--THIS RESEARCHER WHEN HE OR SHE WANTS TO APPLY FOR THE WAIVER OF AUTHORIZATION TO USE THE PHI WITHIN MERCY HOSPITAL, WOULD ALSO BE APPLYING FOR A WAIVER OF AUTHORIZATION TO DISCLOSE THE SAME PHI TO THE OTHER HIPAA COVERED ENTITY, THEY COULD SEEK IT SEPARATELY BUT WHY NOT DO IT TO THE IRB OR PRIEF PRIVACY BOARD. THIS TIME WOULD ASK FOR ITS OWN WAIVER OF AUTHORIZATION FOR THE USE, BUT WOULD ALSO ASK THE IRB OR PRIVACY BOARD FOR A WAIVER OF AUTHORIZATION TO ALLOW IT TO KISS DISCLOSE TO THE OTHER COVEREDDENTITY FOR PURPOSES OF THE COLLABORATIVE RESEARCH. THIS IS THE WAY THAT IT WOULD BE EFFECTED AND A WAY THAT WOULD BE COMPLETELY CONSISTENT WITH HIPAA WHICH IS WHAT WE HAVE TO OBEY BECAUSE WE'RE NOT EXEMPT FROM HIPAA. THE IRB OR PRIVACY BOARD WOULD HOPEFULLY GRANT EACH INSTITUTION'S REQUEST AND REMEMBER THAT UNDER HIPAA YOU'RE ALSO ALLOWED 1 COVERED ENTITY IS ALLOWED ACTUALLY TO--IT DOESN'T HAVE TO MAKE ITS OWN DECISION TO WAIVE AUTHORIZATION OR DISCLOSE, IT CAN ASEED TO ANOTHER COVERED ENTITY'S IRB OR PRIVACY BOARD MAKING THAT DETERMINATION ITSELF. SOMEONE COULD USE--MY POINT IS YOU COULD EITHER HAVE 1 INSTITUTION'S IRB DO ALL OF THIS OR YOU COULD HAVE A CENTRAL IRB DO IT IF YOU WANTED TO. SO THE IRB OR PRIVACY BOARD GRANTS EACH INSTITUTIONS REQUEST FOR DISCLOSURE. AND THERE YOU GO. IN THE HANDY GRAPHIC PERMITTING BOTH INVESTIGATORS TO USE BOTH INSTITUTIONS, PHI, IN THEIR RESEARCH. SO THIS IS THE--SO GOING BACK TO THE SPIRIT OF ALL OF THIS, TO THE SPIRIT OF THE EXEMPTION WHICH IS THAT WE DON'T NEED THE COMMON RULE TO APLOY AS WELL WHEN HIPAA ALREADY PROTECTS ALL OF THE USES OF THE INFORMATION, THAT SPIRIT, THAT PURPOSE IS NOT DAMAGED BY THIS BECAUSE THE DATA UNDER THIS EXAMPLE NEVER LEAVE A HIPAA COVERED ENTITY. THEY NEVER ESCAPE TO A NONCOVERRED ENTITY THAT WOULD NOT BE BOUND BY ALL OF THE PROVISIONS AND THE PROTECTIONS OF THE HIPAA. OKAY? SO HERE'S THE RECOMMENDATION. THIS IS WHAT THE SUBCOMMITTEE IS RECOMMENDING TO YOU. THE XESMG CAN BE READ TO EXTENT TO RESEARCHERS AND 1 RESEARCHERS WITHIN 1 COVERED ENTITY WITHIN PHI, WITH WITHIN A SECOND ENTITY SO ALONG AS A PROVISION OR HIPAA OR WAIVER OR WAIVER OF AUTHORIZATION PERMITTING THE FIRST ENTITY TO DISCLOSE THE INFORMATION TO THE SECOND COLLABORATING COVERED ENTITY. AND THEN, THE--I WON'T READ THIS TO YOU BUT IT'S BASICALLY WHAT I HAVE--I HAVE BEEN DESCRIBING AND THEN AT THE BOTTOM, ONCE THE DISCLOSURE OF PHI FROM 1 COVERED ENTITY TO ANOTHER HAS HAPPENED MOST LIKELY UNDER A WAIVER OF AUTHORIZATION, THEN ALL HIPAA REQUIREMENTS WOULD CONTINUE TO APPLY TO ALL OF THE DATA INCLUDING THE ACCOUNTING REQUIREMENT. BECAUSE WHEN PHI IS DISCLOSED FROM 1 ENTITY TO ANOTHER, UNDER A WAIVER OF AUTHORIZATION, THERE IS A REQUIREMENT THAT THE DISCLOSING ENTITY RECORD THE PERSONS OR ENTITIES TO WHICH IT HAS DISCLOSED SO THAT THE INDIVIDUAL PATIENT OR CLIENT CAN REQUEST AND GET INFORMATION ABOUT THE ENTITIES TO WHICH OR TO WHOM HIS OR HER INFORMATION HAS BEEN DISCLOSED. SO THIS DOES NOT--MY POINT HERE IS HIPAA CONTINUES TO APPLY AND IT ALSO APPLIES IN REGARD TO THE COUNTING FOR DISCLOSURE FIST THERE'S BEEN A WAIVER OF AUTHORIZATION GRANTED. SO LET ME STOP THERE AND SEE IF THERE ARE--IF THERE ARE QUESTIONS OR COMMENTS. >> MARK, LET ME JUST ASK A CLARIFYING QUESTION. SO THAT--THAT WAS WONDERFUL THANK YOU. THIS IS A VERY COMPLICATED TOPIC AND I KNOW THE SUBCOMMITTEE STRUGGLED WITH IT AND I THINK YOU HAVE DONE A BEAUTIFUL JOB OF EXPULLICATING IT. IF WE WEREN'T DISCUSSING THE EXEMPTION, IF THIS IS NOT EXEMPT RESEARCH BUT THIS IS WHAT YOU WANT TO DO TO COMBINE THIS DATA, EVERYTHING YOU SKETCHED OUT TO THIS POINT IS A REQUIREMENT? >> YES. >> I WANT EVERYBODY--THIS LEVEL OF COMPLEXITY WAS NEW TO TO ME, I WANT EVERYBODY TO BE CLEAR THAT SACHRP, AND OUR GUIDELINE PROCESS AND COMPLEXITY ALL MARK HAS DONE IS ACTUALLY DOCUMENT WHAT YOU HAVE TO DO NOW, WHETHER OR NOT YOU HAVE THE EXEMPTION. SO ALL THE RECOMMENDATION IS THAT THE EXEMPTION SHOULD APPLY IN THIS CIRCUMSTANCE BUT ALL OF THOSE OTHER DISCLOSURES AND USES AND WAIVERS, THOSE ARE THINGS THAT ARE REQUIRED NOW, WHETHER OR NOT YOU GET THE EXEMPTION. SO I JUST THINK THAT--THAT'S WORTH SAYING. >> YES, IT IS WORTH SAYING. THANK YOU. >> OTHER COMMENTS OR QUESTIONINGS OR THOUGHTS? --QUESTIONS OR THOUGHTS? >> THIS IS A VERY GOOD POINT. AND LET ME STEP BACK WHAT WHAT I'M ABOUT TO SAY ACTUALLY APPLIES TO ALL THE DETERMINATIONS THAT WOULD OPERATIONALLIZE THE HIPAA EXEMPTION. AND THAT IS THAT RIGHT NOW, WE HAVE INTERNAL PROCESSES WITHIN OUR ENTITIES THAT ARE SUBJECT TO THE COMMON RULE AND TO HIPAA. WE HAVE THE IRB, AND THE IRB STAFF THAT IS THERE TO HOLD THE TOLL GATE FOR USE OF EXISTING EXEMPTIONS, THAT THE IRB POLICY IS SUPPOSED TO DO AND MOST OF THE INSTITUTIONS, MOST INSTITUTIONS DON'T ALLOW INVESTIGATORS TO DECIDEOT EXEMPTION BY THEMSELVES. THEY WANT SOME SUBMISSION OF SOMETHING TO AN IRB OR STAFF MEMBER OR CHAIR PERSON TO MAKE SURE THEY APPLIED THE EXEMPTION, FORGET ABOUT THE EXEMPTIONS, I'M TALKING ABOUT THE EXEMPTIONS UNDER THE COMMON RULE. SO WHAT THIS DOES THOUGH, THE HIPAA EXEMPTION IN THIS CASE, IT ACTUALLY--IT IS A--IT IS ACCOMPLISHES, WHICH IS SUPPOSED TO ACCOMPLISH, THE BYPASSING OF FULL RESEARCH PROTOCOL AND THE GRANTING OF A WAIVER OF CONSENT AND THE APPROVAL--AND THE APPROVAL OF THE ACTUAL PROTOCOL. THEREFORE IT CALLS UPON THE INSTITUTIONAL ADMEN ADMINISTRATORS OF RESEARCH AS WELL AS EITHER THE PRIVACY BOARD OR THE IRB IF IT IS ACTING IN THE ROLE OF A PRIVACY BOARD UNDER HIPAA. IT IS REQUIRED THAT THEY WOULD EXERCISE SOME KIND OF DISCRETION TO MAKE SURE THAT THE INVESTIGATOR WITHIN OUR MERCY HOSPITAL EXAMPLE IS ACTUALLY APPLYING THE HIPAA EXEMPTION IN THE RIGHT WAY. IN OTHER WORDS, YOU KNOW, 1 OF THE THINGS THAT HAS SCARED MANY OF US BECAUSE MANY OF US HAD BITTER EXPERIENCES WITH IT, HAS INVESTIGATORS GOING OFF ON THEIR OWN BEFORE HIPAA EVER CAME ALONG, DOING A STUDY AND SAYING OH IT WAS EXEMPT, I NEVER BOTHERED TO TELL ANYBODY BECAUSE IT WAS EXEMPT AND THEN THEY PUBLISH IT AND ALL HELL BREAKS LOOSE BECAUSE IT WAS AN INCORRECT INTERPRETATION OF THE APPLICATION OF EXEMPTION. THE SAME THING COULD HAPPEN HERE IF INSTITUTIONS ON THEIR OWN DON'T PUT INTO PLACE CERTAIN PROCEDURES TO MAKE SURE THAT THIS HIPAA EXEMPTION WITH ALL ITS COMPLEXITY IS APPLIED BY INVESTIGATORS IN THE RIGHT WAY. SO THERE IS A NEED AND THEANK YOU FOR RAISING THE QUESTION BECAUSE I SHOULD HAVE ACTUALLY STARTED WITH THAT, THERE IS A NEED FOR INSTITUTIONS IN APPLYING THE EXEMPTION TO MAKE SURE THAT THERE ARE INTERNAL PROCESSES TO MAKE SURE THE EXEMPTION IS BEING APPLIED IN THE CORRECT WAY. OKAY? >> SO I'M JUST CURIOUS. SO 1 POSSIBILITY HERE AS YOU THINK OF THE DATA RESIDING WITHIN A HEALTHCARE SYSTEM AND STAYING WITHIN THAT SYSTEM AS SOMEONE WHO'S BEEN HACKED IN EVERY SINGLE HACK INCLUDING UCLAs, I'M NOT WILDLY EXCITED ABOUT THIS IDEA BUT WHATEVER. BUT ACTUALLY AN INSTITUTION CAN BE--SOMEONE CAN BE A RESEARCHER IN A COVEREDDENTITY BUT IN IN--COVERED ENTITY BUT IN FACT THEY'RE USING THE DATA OUTSIDE THE HEALTHCARE SYSTEM OR CAN THAT BE TRUE? IN OTHER WORDS SUPPOSE YOU'RE AT A UNIVERSITY AND YOU HAVE A UNIVERSITY HOSPITAL AND THEREFORE THE UNIVERSITY--WHAT IS THE COVERED ENTITY, IS IT THE UNIVERSITY AS A WHOLE? IS IT THE HOSPITAL? HOW FAR DOES THE COVEREDNESS EXTEND WITHIN THE ENTITY. >> EACH UNIVERSITY--THIS A COMMON QUESTION ACTUALLY BECAUSE WE HAVE UNIVERSITIES, WE HAVE MANY UNIVERSITIES THAT HAVE MEDICAL SCHOOLS AND PUBLIC HEALTH SCHOOLS AND NURSING SKILLS AND PHARMACY SKILLS, WE HAVE MANY UNIVERSITIES THAT OWN MEDICAL CENTERS AND THAT ARE INTEGRATED ACADEMIC MEDICAL CENTER MODELS. THERE ARE OTHERS LIKE THE MOST RECENT SPINOFF OF VANDERBILT WHERE THE HOSPITAL SEPARATED ITSELF FROM THE UNIVERSITY WHERE THE UNIVERSITY IS ACTUALLY A COMPLETELY SEPARATE ENTITY. WHEN AN ENTITY LIKE A MORE TYPICAL UNIVERSITY HAS A MEDICAL SCHOOL FACULTY AWLINGS TREATS PATIENTS AND HAS A HOSPITAL THAT UNIVERSITY WILL HAVE GONE THROUGH IN THE DRAFTING OF ITS HIPAA COMPLIANCE PLAN, A DETERMINE NATION THAT WILL BE ENSHRINED IN SOME KIND OF HIP HIPAA DEMULARRATION AND POLICY AND S. O. P. THESE PARTS OF OUR INSTITUTION WE REGARD UNDER A COVERED ENTITY UNDER HIPAA AND THE OTHER DEPARTMENTS LIKE THE GREEK AND LATIN AND EPIDEMIOLOGIOLOGY AND OTHERS ARE NOT REGARDED AS A COVERED ENTITY UNDER HIPAA. UNDER THIS EXEMPTION, THIS PARTICULAR EXEMPTION AN INVESTIGATOR WHO IS PART OF THE COVERED ENTITY PIECE OF THE LARGER HYBRID ENTITY HE OR SHE WOULD ALSO BE ABLE TO USE THE INFORMATION WITHIN--WITHIN, WITHIN THE COVEREDDENTITY PORTION OF THE HYBRID ENTITY. THEY COULDN'T TAKE IT OUT AND SHOW IT GRADUATE STUDENTS AND EPIDEMIOLOGY UNLESS THERE HAVE BEEN SOME KIND OF WAIVER OF AUTHORIZATION THAT ALLOWED THEM TO DO THAT. SO I GUESS 1 THING I WAS ASSUMING WAS THAT PART OF HIPAA, IS THE ACTUAL ADEQUATE PROTECTION OF THE DATA, THE APPLICATIONS MR. IICATION OF SUFFICIENT PROTECTION SAY ENCRYPTION, THINGS THAT PREVENT AND IDENTIFY ATTEMPTS TO GET INTO SYSTEMS AND SO ON. >> RIGHT. >> SO YOU'RE SORT OF SPEAKING TO THE DISCLOSURE PART OF IT, BUT IS THERE SOMETHING IN HERE THAT'S SPEAKS TO THE DATA PROTECTION PART OF IT? >> THERE IS BECAUSE BY DEFINITION, A HIPAA COVERED ENTITY IS REQUIRED TO ABIDE BY ALL THESE VARIOUS PROTECTIONS LIKE THE ENSCRIPGZ, TECHNOLOGY AND OTHER THINGS, THAT'S THE--THE SECURITY RULE, WHICH APPLIES TO ALL OF THESE ENTITIES AS WELL, SO THEY'RE ALREADY REQUIRED TO HAVE DISASTER RECOVERY PROGRAMS AND FIRE WALLS AND USER ACCESS SYSTEMS AND LIMITED ACCESS THE EXPIRATION OF ACCESS WHEN A PERSON LEAVES THE WORKFORCE, TERMINATED OR DEPARTS VOLUNTEERS UNSUPPORTED TARLY SO ALL OF THAT--VOLUNTEERS UNSUPPORTED TARLY, SO ALL OF THAT IS IN WHAT I'M TALKING ABOUT. >> SO WHEN SOMEONE WANTS TO INVOKE THIS EXEMPTION WHO CONSIDERS THAT QUESTION OF WHERE THESE DATA THAT ARE GOING TO BE DISCLOSE--THAT WAS ACTUALLY SIGNED BY THE INDIVIDUALS LONG AGO WHICH IS UNLIKELY IN THESE BUT IT'S POSSIBLE IN THESE SITUATIONS. SO THE IRBs OR PRIVACY BOARD WILL LOOK AT THE PROPOSED WAIVER AND THEY WILL SEE EXACTLY, YOU KNOW WHETHER THEY THINK THAT IT'S--IT POSES MORE THAN A MINIMAL RISK TO THE PERSON OR NOT. THE THIRD PERSON THAT HAS TO MAKE THE DECISION IS ACTUALLY THE COVEREDDENTITY ITSELF BECAUSE SOME ADMINISTRATOR WITHIN THE COVEREDDENTITY NEEDS TO SAY, OH THIS IS AN ACCURATE AND APPROPRIATE APPLICATION OF THE HIPAA EXEMPTION TO THIS PARTICULAR RESEARCH ACTIVITY AND HE OR SHE HAS TO DO THAT FIRST OF ALL BECAUSE OF GOOD ACADEMIC OVERSIGHT AND YOU WANT TO THAT IN COMPLIANCE OVERSIGHT, YOU WANT THAT TO HAPPEN, BUT ALSO THE COVERED ENTITY IS THE 1 THAT IS LIABLE AS WELL AS A CORPORATE ENTITY, IF THE INDIVIDUAL MISUSES THE INDIVIDUAL RESEARCHER OR MISUSED OR MISDISCLOSES THE INFORMATION, THE P, I AND VIOLATES HIPAA SO ALL 3 OF THOSE KIND OF STAR VS TO ALIGN. >> IS THIS GOING TO BE COVERED IN THE GUIDANCE AT ALL. I MEAN YOU PROBABLY ASSUME THAT ORGANIZE ORGANIZATIONS THAT ARE COVERED UNDER HIPAA ARE AWARE OF THIS BUT I THINK IT'S PERHAPS SMK YOU WANT TO RERAISE IN THE GUIDANCE DOCUMENT BECAUSE MY EXPERIENCE IS, I DON'T KNOW IF PRIVACY BOARDS ARE DIFFERENT BECAUSE I DON'T RUN A PRIVACY BOARD BUT IRBs ARE VERY DIFFERENT IN THE DEGREE TO WHICH THEY COVER ACTUAL ISSUES OF DATA SECURITY. MANY--SOME DO, VERY FEW DO, BUT MANY DON'T AND SO I WONDER IF YOU WANT TO RERAISE THESE QUESTIONS AGAIN BECAUSE IT'S SOME FAIRLY SENSITIVE PARSING OF INTERPRETATION. I WOULD--I WOULD COMMEND EVERYONE'S ATTENTION TO THE PAGE 5 OF THE GUIDANCE DOCUMENT BECAUSE WE ACTUALLY HAVE A COUPLE LENGTHY PARAGRAPHS ABOUT THIS ISSUE, THE NEED ESSENTIALLY TO MAKE THE EXISTING MECHANISMS MUCH MORE ON ROBUST IN AN INSTITUTION WILL TAKE ADVANTAGE OF THIS PRECISELY FOR THE REASONS THAT YOU RAISE. MARISSA, DID YOU WANT TO ADD TO THAT? >> I THINK IT MIGHT BEFUL TO CONCEPTUALIZE THESE HYBRID ENTITIES FOR FOLKS TO THINK OF THEM AS A COVEREDDENTITY COVEREDDENTITY--COVERED ENTITY AND AN OUTSIDE ENTITY. SO IN EVEN 1 INSTITUTION, IF YOU'RE HID BRIDDIZED HF-HYBRIDIZED WITHIN THAT THE USE WOULD FALL UNDER THE HIPAA EXEMPTION. BUT ANY SHARING OF INFORMATION TO OTHER PARTS OF THE INSTITUTION THAT ARE NOT PART OF THE COVERED COMPONENT IS NOT A USE, IT'S A DISCLOSURE. AND SO THAT HAS TO HAVE IT'S OWN PERMISSION AND IT WOULDN'T--AND ANY USE BY THE FOLKS OUTSIDE OF THE HIPAA COMPONENT WOULD NOT BE A USE UNDER THIS EXEMPTION. HOPEFULLY THAT MAKES SENSE. >> I THINK IN THIS HYBRIDIZED SYSTEM, IT'S--IT'S CONFUSING TO THINK ABOUT DIGS CLOSURE AS SOMETHING THAT GOES FROM 1 KIND OF PERSON TO ANOTHER KIND OF PERSON BECAUSE THE PEOPLE ARE HYBRIDIZED, TOO, SO YOU HAVE A JOINT APPOINTMENT IN THE SCHOOL OF MEDICINE AND THE SCHOOL OF PUBLIC HEALTH BUT THE SCHOOL OF PUBLIC HEALTH IS OUTSIDE THE HIPAA SYSTEM AND THE SCHOOL OF MEDICINE IS WITHIN THE HIPAA SYSTEM SO--AND THE INDIVIDUAL HAS TO BE UNDERSTANDING THAT THEY CAN'T MOVE THEIR DATA FROM 1 PLACE TO ANOTHER PLACE AND THEY HAVE TO ORGANIZE THEIR RESEARCH TEAMS IN THE APPROPRIATE KIND OF WAYS. IT'S COMPLICATED. VERY COMPLICATED. >> IT'S TRUE AND THE BALANCE BETWEEN ALLOWING THE FLEXIBILITY FOR AN INDIVIDUAL WORKFORCE MEMBER TO WEAR DIFFERENT HATS IS, YOU KNOW--IT HAS TO BE ACCOMPANIED BY UNDERSTANDING BY THEM OF WHAT THEY CAN DO WHEN THEY'RE WEARING 1 HAT OR THE OTHER 1 AS FAR AS USING THE INFORMATION. >> ALTHOUGH THEY HAVE TO DO THAT RIGHT NOW EVEN WITHOUT THE HIPAA EXEMPTION. >> RIGHT. RIELT. >> BECAUSE ALL OF THIS IS GOING ON WITHOUT THE HIPAA EXEMPTION BEING APPLIED. YOU KNOW? >> MARK, CAN I ASK YOU IF YOU KNOW--DO THE MAJORITY OF THE INSTITUTIONS USE THEIR IRBs AS THE PRIVACY BOARD, THAT WAS MY EXPERIENCE AND I SEE YOU'RE NODDING BECAUSE 1 OF THE THINGS WHEN I WAS READING THIS AND I FOUND IT VERY CHALLENGING AND I SAY THAT AS SOMEBODY I AM A LAWYER. I HAVE LEFT MOST OF THE DETAILS EXCEPT AS IT RELATES TO HIPAA TO OTHERS. I WAS STRUCK PARTLY BY THE COMPLEXITY WHY WOULD SOMEBODY USE THIS? GIVEN IF THE PRIVACY BOARD IS THE IRB AND I HEARD YOU EXPRESS IT ACTUAL LOW BEST HERE WHICH IS--SORT OF THE ENCOURAGEMENT THROUGH THE IRB DON'T GO THROUGH THE REST OF US, DON'T ASK THOSE OTHER QUESTIONS ABOUT THE PROTOCOL BECAUSE IT'S WITHIN THE HIPAA SYSTEM AND I THINK IT WOULD BE PERHAPS HELPFUL TO BE EXPLICIT ABOUT THAT BECAUSE I ALSO FOUND YOUR--OR YOUR ASSOCIATES GRAPHICS TO BE HELPFUL AGAIN TO GET THROUGH, WE MIGHT WANT TO INCLUDE THEM. BUT TO SPLAIN, THERE REALLY IS--THIS IT A COMPLICATED THING. AGAIN, NOT BECAUSE OF ANYTHING EXCEPT IT'S A COMPLICATED THING. BUT THERE ARE--THERE IS A REASON TO THINK VERY HARD ABOUT SETTING THIS UP AND THAT IS REALLY TO TAKE FULL ADVANTAGE OF THIS WITHOUT HAVING TO GO THROUGH SOME OF THE OTHER THINGS THAT WE MIGHT OTHERWISE GO. BECAUSE OTHERWISE IT WAS LIKE, WELL IF WE'RE GOING THROUGH--AS I'VE ALWAYS UNDERSTOOD IT, BASICALLY THE SAME ASSESSMENT FOR A WEAR--WAIVER OF CONSENT BUT WE'RE SAYING IT FOR THE IRBs YOU YOU DON'T HAVE TO GO INTO THE OTHER THINGS YOU MIGHT HAVE OTHERWISE GONE INTO BECAUSE WE'RE SAYING IT'S NTS SYSTEM THAT IS WORKING. --IN THE SYSTEM THAT IS WORKING. >> MY IMPRESSION HAS ALWAYS BEEN THAT OF ALL THE EPTITIES THAT I'VE EVER--FOR WHICH I'VE EVER DONE WORK MYSELF, I WOULD SAY THAT 19 OUT OF 20 DON'T HAVE A SEPARATE PRIVACY BOARD, THEY USE THE IRB AS THE PRIVACY BOARD. I DON'T KNOW IF THAT'S YOUR EXPERIENCE AS WELL? >> I'M NOT ACTUALLY SURE ABOUT HOW THAT'S SET UP FOR THE MAJORITY OF INSTITUTIONS, ALTHOUGH I HAVE HAD SOME FEEDBACK JUST RECENTLY WHERE FOLKS ARE TELLING ME THAT IF THEY--THEY'VE ALWAYS USED THE IRB FOR THE PRIVACY DETERMINATION FOR A WAIVER, BUT BECAUSE THEY NO LONGER NEED THE IRB TO MAKE THE--DO THE FULL REVIEW OR AN EXPEDITED REVIEW TO REMOVE BURDEN FROM THE IRB, THEY'RE THINKING ABOUT SETTING UP A PRIVACY BOARD. INSTEAD OF CONTINUING TO USE THE IRB THE WAY THEY USED TO. SO I DON'T KNOW TO WHAT EXTENT INSTITUTIONS ARE THINKING ABOUT THIS BUT I HAVE HEARD IT FROM A COUPLE OF DIFFERENT PEOPLE THAT THAT'S A POSSIBILITY. >> LAST THING I WOULD SAY IS THAT, YOU KNOW, LET ME TELL YOU THE ALTERNATIVE HERE. THE ALTERNATIVE TO THIS RECOMMENDATION IS THAT WE LIMIT IT TO THE USE OF 1 RESEARCH TEAM WITHIN 1 COVEREDDENTITY AND THAT'S IT. FOR THIS DAY AND AGE DOESN'T REALLY, IT DOESN'T REALLY HELP ANYBODY FRANKLY BECAUSE IT'S THE COMBINATION OF DATA THAT REALLY MATTERS. SO,-- >> AND MARK, THE SHARED DATA UNDER THE CURRENT CIRCUMSTANCES WITHOUT THE EXEMPTION IS STILL COVERED BY HIPAA SO YOU HAVE ALL THOSE PROTECTIONS. >> EXACTLY. SO IT SEEMS COMMON SENSE. >> SO, OKAY. WELL I'M GOING TO GO ON TO THE SECOND POINT THEN IF THAT'S OKAY? STEPHEN IS THAT OKAY? OKAY, ISSUE 2. A BUSINESS ASSOCIATE AS I DESCRIBED BRIEFLY BEFORE IS AN ENTITY THAT PERFORMS 1 OF THE RECOGNIZED BUSINESS ASSOCIATE FUNCTIONS UNDER HIPAA REGULATIONS ON BEHALF OF A HIPAA COVEREDDENTITY. THESE KINDS OF ACTIVITYINGS CAN INCLUDE THE ACTIVITY OF ACTUALLY DEIDENTIFYING PHI, IN OTHER WORDS YOU CAN HIRE A DATA XUSM TO LOOK AT YOUR PROTECTED HEALTH INFORMATION IN THE HOSPITAL SYSTEM AND DEIDENTIFY THOSE DATA AND THAT WOULD BE A BUSINESS FUNCTION. YOU CAN USE A BUSINESS AS AN ASSOCIATED FUNCTION AS A DATA SET, USE A BUSINESS ASSOCIATE TO DO DATA AG GRIIGATION OF ALL OF YOUR DATA AND CALL THE DATA AND SORT THE DATA AND YOU CAN ALSO USE EXTERNAL ORGANIZATIONS AS MANY HOSPITALS DO TO CONDUCT REVIEWS AND QUALITY ASSURANCE REVIEWS. THESE ARE ALL KINDS OF BUSINESS-ASSOCIATED ACTIVITIES AND WHEN I COVERED ENTITY OR HOSPITAL SYSTEM DECIDES TO USE A DATA COMPANY TO DO ANY OF THESE THINGS OR A QUALITY ASSURANCE COMPANY OR CONSULTING FIRM FOR THESE KINDS THINGS, REMEMBER THAT THE DATA COMPANY AND THE QUALITY ASSESSMENT CONSULTING COMPANY, THEY ARE NOT BILLING THIRD PARTY PAYORS THEMSELVES FOR SERVICES THEY RENDER. SO THEY'RE NOT COVERED ENTITIES UNDER HIPAA. SO THE ONLY WAY TO--FOR A HOSPITAL TO GIVE, TO DISCLOSE ALL OF ITS PHI, TO THIS NONCOVERRED ENTITY IS BY BINDING THE COVERED ENTITY WITH A BUSINESS ASSOCIATE AGREEMENT. AND ACTUALLY I'LL TELL YOU HISTORICALLY,--HOW LONG HAVE YOU BEEN AT OCR MARISSA? >> EIGHT YEARS. >> SO THIS WAS DRAFTED BY WAY OF HISTORICAL EXPLANATION, THIS IS NOT A THIS IS NOT A HISTORICAL ACCIDENT THAT THIS HAPPENED. WHAT HAPPENED WAS THIS, WHEN PEOPLE WERE SITTING AROUND IN THE LAST DAYS OF THE CLINTON ADMINISTRATION DRAFTING THE HIPAA PRIVACY RULE AND REALIZED IT WAS CONTINKENT ON ELECTRONIC TRANSACTIONS FOR REEMBUSKERMENT PURPOSES AND THEN THEY STARTED THINKING ABOUT A HOSPITAL--THAT GAVE THEM JURISDICTION OVER ALL THE HOSPITALS BAIRVEGLY EXCEPT A FEW SHRINERS HOSPITALS THAT DON'T BILL THIRD PARTY PAYORS AND SOME DENTAL PRACTICES AND PSYCHIATRY PRACTICES AND DERMATOLOGY PRACTICES THAT ONLY ACCEPT CASH OR CHECK, THOSE ARE NOT COVERED UNDER HIPAA BUT THEY'RE LOOKING AT 99% OF THE AMERICAN HEALTHCARE SYSTEM WHICH IS ALL OF WHICH ARE COVERED ENTITIES UNDER HIPAA AND THEY REALIZE, OH, BUT THE BUSINESS OPERATIONS OF ALL OF THESE ENTITIES EXTEND TO THE TV COMPANIES THAT COME IN AND PUT THE TVS IN THE HOSPITALS, THEY EXTENT TO THE QUALITY ASSURANCE CONSULTING FIRMS, THE UTILIZATION REVIEW 18thS BUT THEY'RE GETTING ALL OF THESE DATA BUT WE DON'T HAVE DIRECTLY ON THESE ENTITIES BECAUSE THEY'RE NOT DOING ELECTRONIC TRANSACTIONS THEMSELVES FOR REIMBURSEMENT SERVICES SO WHAT DO WE DO? BECAUSE IF WE CAN'T COVER THEM, IT'S A HUGE GAP IN THE SYSTEM? SO BEING INVENTIVE REGULATORS, THE GENERAL COUNSEL'S OFFICE MANY OF WHOM ARE FRIENDS OF MINE, FORMER GENERAL COUNSEL THEY DECIDED WHAT THEY WOULD DO IS INSTEAD OF IMPOSING BECAUSE THEY CAN'T BECAUSE OF JURISDICTION, HIPAA ON THESE--THESE EXTERNAL RING DIRECTLY, THEY WOULD INSTEAD IMPOSEOT COVERED ENTITIES, THE OBLIGATION THAT IF YOU WANT TO CONTRACT WITH AN OUTSIDE ENTITY YOU MUST PUT IN THE CONTRACT THAT THE OUTSIDE ENTITY IS BOUND BY HIPAA. SO IT IS APPLYING JURISDICTION TO WHAT YOU HAVE IN ORDER TO EXTEBD YOUR JURISDICTION TO THAT WHICH YOU DON'T HAVE AS OF RIGHT. THIS IS THE THEORY, THIS IS HOW BUSINESS ASSOCIATED CAME TO BE IN THE FIRST PLACE. OVER THE YEARS AND I'LL SPARE YOU THE DETAILS AND MARISSA KNOWS BETTER THAT KNOW I DO, BUT OVER THE YEARS THE BUSINESS ASSOCIATE CONTRACT REQUIREMENTS HAVE BEEN MORE AND MORE RIGOROUS SO THAT TODAY A BUSINESS ASSOCIATE IS BASICALLY WHEN YOU DECIDE AS A NONCOVERRED ENTITY TO DO BUSINESS, TAKE MONEY AND DO BUSINESS WITH A HOSPITAL SYSTEM OR ANOTHER COVERED ENTITY, WHICH WILL ALSO BE INSURANCE PLANS, THEN YOU UNDERSTAND THAT YOU ARE GOING TO HAVE TO STIEN--SIGN THIS AGREEMENT THAT SAYS YOU ARE BOUND BY THE HIPAA RULES IN REGARD TO THE DAT AWE GET, PHI YOU GET AND IF YOU VIOLATE HIPAA YOU ARE ESSENTIALLY SUBJECT TO THE SAME KINDS OF SANCTIONS AND PENALTIES. SO THIS IS WHAT A BUSINESS ASSOCIATE IS. I WILL STOP THERE IN CASE YOU THINK I SAID ANYTHING WRONG? >> NO. >> [LAUGHTER] >> OKAY. SO THEN THE QUESTION BECOMES--YES? >> SO CAN I JUST ASK A QUESTION. THOSE ARE FUNCTIONS IN THE FIRST BULLET, THOSE ARE DIFFERENT FUNCTIONS. IS THERE ANYTHING THAT RELATES TO THE PURPOSE OF THE THOSE FUNCTIONS? IN OTHER WORDS, WHY ARE YOU CREATING A DEIDENTIFIED DATA SET? YOUR YOU--WHY ARE YOU CREATING A LIMITED DATA SET? IS THERE ANYTHING THAT SPEAKS TO WHY YOU ARE DOING THAT BECAUSE YOU COULD BE DOING THAT, I GUESS FOR QUALITY CONTROL PURPOSES OR YOU COULD BE DOING IT FOR RESEARCH PURPOSES OR YOU COULD BE TREADING WAVY LINE BETWEEN THOSE 2? >> RIGHT. WELL, THAT'S A VERY GOOD QUESTION AND IT IT IS--I'LL GIVE YOU WHAT I THINK THE ANSWER, AND MARISSA CAN CORRECT IF I'M WRONG, BUT THE ANSWER IS JUST THE ANSWER. I'M NOT SURE THAT IT HAS A LOT OF--I MEAN IT AS A CERTAIN INTERNAL LOGIC BUT BASICALLY, A BUSINESS ASSOCIATE IS A NONCOVERRED ENTITY THAT HELPS YOU DO OPERATIONS, TREATMENT AND PAYMENT--I'M SORRY OPERATIONS AND PAYMENT, NOT TREATMENT. IF IT'S A TREATING ENTITY IT'S NOT--2 ENTITIES TREATING THE SAME PATIENT, THEY CAN SHARE DATA FOR THE PURPOSE OF TREAT THAGOREAN PATIENT. --TREATING THAT PATIENT. IF IT'S A BUSINESS ASSOCIATE IT'S HELPING YOU PERFORM OPERATIONS OR REIMBURSEMENT FUNCTIONS. THE PROCESS OF DEIDENTIFYING DATA OR RENDERING IDENTIFIABLE DATA INTO A LIMITED DATA SET IS REGARDED AND THAT IS WHERE IT IS WHAT IT IS IS REGARDED AS A BUSINESS OPERATION FUNCTION. REGARDLESS OF WHAT THE PURPOSE IS, OF DEIDENTIFYING THOSE DATA. SO THAT'S THE ANSWER TO YOUR QUESTION AND I MEAN IT'S--YOU KNOW 1 COULD DECIDE THE OTHER WAY BUT THAT'S WHAT THE TEST IS. >> YEAH, I'LL ELABORATE ON THAT. SO THE--THE DATA AGGREGATION FUNCTION IS PART OF THE DEFINITION OF A BUSINESS ASSOCIATE, AS A BUSINESS ASSOCIATE FUNCTION WHEREAS THE PURPOSE BEHIND WHAT YOU'RE DOING IS REGULATED AND A DIFFERENT PART OF THE RULE AND HAS TO DO WITH PERMISSIONS. SO, IN THE DEFINITION IT DOESN'T SAY, YOU KNOW WHAT YOU CAN USE AND DISCLOSE OR WHEN FOR THE DATA AGGREGATION PURPOSE BUT BASED ON THE PURPOSE, IF THEY'RE DOING IT FOR HEALTHCARE OPERATIONS OR FOR RESEARCH PURPOSE, USUALLY IT'S NOT GOING TO BE BECAUSE OF RESEARCH ITSELF IS ISN'T--ISN'T A HEALTHCARE OPERATION, THEN THAT'S WHERE--THAT'S WHERE THE PURPOSE COMES IN, WHEN YOU GET TO THE PERMISSIONS FOR USE AND DISCLOSURE. >> SO YOU'LL NOTICE THAT WHAT'S LEFT OUT HERE IS THAT WHEN 1 ENTITY, WHEN A COVERED ENTITY WANTS TO DO 1 ACTIVITY ONLY AND THAT IS RESEARCH WITH A NONCOVERRED ENTITY, THEN THE NONCOVERRED ENTITY IS NOT ACTUALLY DOING ANYTHING THAT REQUIRES IT UNDER HIPAA TO HAVE--TO BE BOUND BY A BUSINESS ASSOCIATE AGREEMENT IF IT'S PURE RESEARCH. SO SO THE QUESTION THEN BECAME AND THIS IS LIKE THE--THE QUESTION BEHIND ALL OF THIS IS, WELL, IF YOU ARE MERCY HOSPITAL AND YOU WANT AN OUTSIDE RESEARCHER IN THE EPIDEMIOLOGY DEPARTMENT OR IN THE UNIVERSITY DOWN THE STREET, YOU WANT THAT DEPARTMENT OF BIOSTATISTICS TO DO YOUR RESEARCH, CAN YOU JUST BIND THEM WITH THE BUSINESS ASSOCIATE AGREEMENT EVEN THOUGH ALL THEY'RE DOING IS HELPING YOU DO RESEARCH AND THAT WAY YOU CAN PULL THEM INTO YOUR HIPAA COVERED ENTITY TO USE THIS EXEMPTION? COULD YOU DO THAT? SO WE DEBATED THAT, A LOT, BACK AND FORTH AND BASICALLY, THE DECISION WAS MADE FOR US BY MARISSA AND THE GOOD ANSWERS SHE GAVE BECAUSE MARISSA, BAIRVEGLY SAID AND CORRECT ME IF I'M WRONG, SHE SAID, YOU CAN'T JUST DO THAT AND WHEN THE PURPOSE--WHEN THE ONLY PURPOSE OUTSIDE IS RESEARCH BECAUSE RESEARCH IS NOT AN ACTIVITY THAT REQUIRES A BUSINESS ASSOCIATE AGREEMENT AND SO WE AT OCR WOULD NOT RECOGNIZE EVEN IF YOU SIGNED A B. A. A. WE WOULDN'T RECOGNIZE THAT AS A LEGITIMATE B. A. A. FUNCTION AND SO WE WOULDN'T ENFORCE AT THIS TIME THAT WAY AGAINST THE NONCOVERREDDENTITY. SO IF THAT'S THE CASE, THEN OUR--FROM OUR POINT OF VIEW AS A SUBCOMMITTEE WE COULDN'T EVEN IF WE WANTED TO RECOMMEND THAT YOU COULD BIND THE OUTSIDE COVERED ENTITY BY B. A. A. AND PULL THEM IN AND EVERYBODY'S HAPPY WITH THE EXEMPTION. >> SURE. AND I JUST WANT TO CLARIFY THAT YOU CAN PUT TOGETHER SOMETHING THAT LOOKS LIKE A BUSINESS ASSOCIATE AGREEMENT, THAT'S ESSENTIALLY A CONTRACT WITH SOMEONE ELSE TO WHOM YOUR DISCLOSING INFORMATION. IT'S JUST THAT YOU CAN'T--AND THEN THEY WILL BE CONTRACTUALLY RELIABLE TO YOU BUT YOU CAN'T AS A COVERED ENTITY MAKE ANOTHER OUTSIDE NONCOVERRED ENTHUSIASM IRT SUBJECT TO OUR ENFORCEMENT. UNLESS THEY'RE A BUSINESS ASSOCIATE. >> A REAL BUSINESS ASSOCIATE. >> SO MARK WHY DON'T YOU GO THROUGH THIS QUESTION 2 BECAUSE WE'RE ALREADY GETTING TO THE MEAT OF IT. >> YEAH, WE ARE GETTING TO THE MEAT OF IT. SO,--SO, SO--I HAVE A HANDY GRAPHIC FOR THIS TOO. I FORGOT ABOUT THIS GRAPHIC. OKAY. [LAUGHTER] SO LET ME USE THE GRAPHIC TO ILLUSTRATE. SO WE HAVE MERCY HOSPITAL, OUR FRIEND MERCY HOSPITAL OVER HERE WHICH HAS PHI AND THEN HAVE YOU A DATA CORPORATION OVER HERE. SO CAN MERCY TRANSFER PHI TO DATA CORP TO PERFORM BUSINESS œOF COURSE IT CAN.S? REAL BUSINESS ASSOCIATE FUNCTIONS, IT CAN DISCLOSE THE PHI OVER HERE AND IT DOES THAT IF BUSINESS ASSOCIATE AGREEMENT FUNCTIONS ARE AUTHENTIC AND THAT'S MY TERM. THAT'S NOT A HIPAA TERM, AND MERC EXPE--MERCY AND DATA ENTER INTO THE AGREEMENT THAT HAVE ALL THE BELLS AND WHISTLES UNDER THE VARIOUS HIPAA REGULATIONS AND AMENDMENTS, TOO. SO THIS IS ALLOWED, RIGHT? NOW, SUBSEQUENT TO THE ACTIVITIES DESCRIBED IN THE PREVIOUS SLIDE WHICH ARE CONDUCTED--LET ME JUST GO BACK FOR A SECOND. REMEMBER THE PREVIOUS SLIDE WAS A TRUE B. A. A. FUNCTION? LET'S SAY IN THAT EXAMPLE, THE DATA CORPORATION WAS ASSISTING WITH QUALITY ASSURANCE AND REAL WORLD EVIDENCE ACTIVITIES FOR THE LEARNING HEALTH SYSTEM AS A QUALITY ASSURANCE MECHANISM. SUBSEQUENT TO THE ACTIVITIES AS DESCRIBED IN THE PREVIOUS SLIDE WHICH ARE CONDUCTED CONSIST WENT HIPAA REQUIREMENTS CAN MERC EXPE DATA CORPORATION THEN USE PHI UNDER THE EXEMPTION FOR COMMON RESEARCH? IN OTHER WORDS, THE COVERED ENTITY WENT TO THE DATA CORPORATION AND SAID CAN YOU HELP US ASSESS THIS QUALITY ASSURANCE PROBLE BY LOOKING AT OUR DAT PATHWAY GIVES AND THE COVERED ENTITY SAYS GIVE US THE B. A. A., BIND US, WE DO THE WORK FOR YOU, THEY DO IT. THEY HAVE A STARTLING FINDING. THAT I DECIDE THAT 1 PARTICULAR APPROACH TO A SURGICAL OPERATION OR INFECTION CONTROL WAS INCREDIBLY USEFUL SO THEY WANT TO LOOK AT THE DATA AGAIN FOR THIS PURPOSE OR MORE DATA FROM MERCY HOSPITAL FOR THIS PURPOSE. SO SUBSEQUENT TO THE TRULY AUTHENTIC BUSINESS ASSOCIATE ACTIVITIES, CAN THESE 2 ENTITIES THEN ENGAGE IN COMMON RESEARCH UNDER THE HIPAA EXEMPTION? YES, ALL THE RESEARCH ACTIVITIES HANDLED BY DATA FALL UNDER OCR JURISDICTION BECAUSE OF THE TRULY--THE AUTHENTIC BUSINESS ASSOCIATE ACTIVITIES. NOW, WHAT ABOUT THE SITUATION IN WHICH MERCY HOSPITAL AND A UNIVERSITY DECIDE THAT THEY WOULD LIKE TO--THIS HOSPITAL DECIDES IT WANTS TO TAKE, AND THIS FANCY INVESTIGATOR DECIDES HE OR SHE WANTS TO TAKE ADVANTAGE OF THE FABULOUS NEW HIPAA EXEMPTION AND USE IT TO BRING IN A CO INVESTIGATOR AT A NONCOVERREDDENTITY WHICH COULD ALSO BE THE NONCOVERRED PART OF THE HYBRIDDENTITY IN OUR PUBLIC HEALTH GOAL EXAMPLE. CAN MERCY UNDER THIS SYSTEM TRANSFER PHI TO SERVE AS A CO INVESTIGATOR ASSUMING THE PARTIES EXECUTE A BUSINESS ASSOCIATE AGREEMENT? NO. BECAUSE THE UNIVERSITY AND THE CO INVESTIGATOR WOULD NOT BE SERVING AS AUTHENTIC BUSINESS ASSOCIATES, AGAIN MY TERM NOT A HIPAA TERM. SO, DISCLOSURE NOT ALLOWED, THEY CAN SIGN WHATEVER THEY WANT AS MARISSA SAID AND IT CAN BIND THEM PRIVATELY BUT IT WILL NOT SUBJECT THE NONCOVERRED NONBUSINESS ASSOCIATE CO INVESTIGATOR TO THE JURISDICTION OF OCR FOR THESE PURPOSES. OKAY? SO THIS EXPLAINS THE 2 DIFFERENT SCENARIOS HERE. >> OKAY, I'VE BEEN THROUGH THIS, THIS WEEK, SO IT'S VR FRESH IN MY MIND. SO IT SEEMS VERY PECULIAR TO ME, THAT ALL OF A SUDDEN BECAUSE YOU HAVE AN AUTHENTIC BUSINESS ASSOCIATE AGREEMENT YOU CAN THEN TURN THAT INTO CO INVESTIGATED RESEARCH SIMPLY BECAUSE YOU ALREADY HAD 1. SO IT SORT OF--CERTAIN KINDS OF FIRMS CAN THEN BECOME RESEARCH FIRMS UNDER THIS WHEREAS OTHER KINDS OF FIRMS CAN'T BECAUSE IF YOU DON'T HAVE A REASON TO HAVE A BUSINESS ASSOCIATE AGREEMENT, THEN YOU CANNOT DO RESEARCH UNDER THIS WHEREAS IF YOU DO HAVE A REASON THEN SUDDENLY YOU CAN DO RESEARCH. THAT SEEMS SOMEWHAT PECULIAR TO ME. >> BUT YOU CAN DO THE RESEARCH NOW. YOU JUST NEED TO HAVE A FULL IRB PROTOCOL WITH A WAIVER OF CONSENT. >> I UNDERSTAND THAT. >> YEAH. >> BUT IT IS--IT SEEMS A LITTLE PECULIAR THAT SOMETHING TURNS ITSELF AROUND IN AN ODD WAY. THE OTHER THING ABOUT THESE SLIDES BECAUSE THIS IS SO UTTERLY COMPLICATED, I HAVE A FEELING THAT IF WE PUT OUT GUIDANCE OR GUIDANCE APPEARS PEOPLE WILL BE EXTREMELY GRATEFUL HOWEVER, I THINK THAT COVERED ENTITIES MAY WELL INTERPRET A SLIGHT LIKE THIS, NOT TO SAY, NO YOU CAN'T DO THIS UNDER A HIPAA WAIVER BUT NO YOU CAN'T DO THIS. SO MY SUGGESTION IS THAT YOU ALTER THIS SLIDE TO SAY, NO, YOU CAN'T DO IT UNDER A HIPAA WAIVER, HERE'S HOW YOU CAN CAN DO IT. JUST SIMPLY SAY SOMETHING THAT SAYS HERE'S HOW YOU CAN DO IT. >> YEAH, THE SLIDES ARE NOT GOING TO BE PART OF THE RECOMMENDATION. THEY'RE PURELY PEDGOGICAL. >> BUT AS THE RECOMMENDATIONS EVOLVE, I DO THINK WHAT YOU'RE SAYING IS EXTREMELY IMPORTANT TO SAY, OKAY, HERE'S HOW CAN YOU DO IT CORRECTLY. SO IT'S IMPORTANT TO SAY, HERE'S HOW YOU CAN'T DO IT CORRECTLY. HERE'S HOW YOU CAN DO IT CORRECTLY JUST AS A REMINDER THESE THINGS ALREADY EXIST. BUT THIS IS VERY HELPFUL. >> SO THE RECOMMENDATION HERE IS BASICALLY THE FOLLOWING, GIVEN THAT ANENTITY PERFORMS ENUMERATED OBJECTS ASSOCIATE FUNCTIONS THAT IS IN MY TERMINOLOGY AUTHENTIC FUNCTIONS UNDER A B. A. A. WOULD BE SUBJECT TO THE HIPAA PRIVACY RULE FOR THE USE OF DAT. WE RECOMMEND THIS IS THE SUBCOMMITTEE RECOMMENDATION THAT THE HIPAA EXEMPTION SHOULD EXTEND TO SECONDARY RESEARCH IN WHICH THE BUSINESS ASSOCIATE IS BY ENGAGING IN 1 OF THESE PARTICIPATING ALONGSIDE THE COVERED ENTITY IS THE RESEARCH. BUT IT'S IMPORTANT TO NOTE THAT THE RECOMMENDATION DOES NOT EXTEND TO THE FOLLOWING EXTINGUISHINGLY ANY EXTENSION OF THE HIPAA XEMPLEGZ TO COVER RESEARCH RELATED ACTIVITIES CARRIED OUT BY BUSINESS ASSOCIATED MUST BE LIMITED TO ACTIVITIES CONSIDERED TO BE BUSINESS ASSOCIATE ACTIVITIES UNDER HIPAA, THE EXCLUSION OF THE B. A. A. WITH THE COVERED ENTITY IS NECESSARY AND BETWEEN A COVEREDDENTITY AND NONCOVERRED ENTITY IS NECESSARY BUT INSUFFICIENT TO PREVENT A NONCOVER THE ENTITY TO PARTICIPATE IN RESEARCH FOR WHICH THE HIPAA EXEMPTION MAY OTHERWISE BE AVAILABLE. SO THAT'S THE RECOMMENDATION. >> MARK, I HAVE JUST ANOTHER QUESTION TO TRY TO CLARIFY THIS BECAUSE WHAT IT SEEMS TO ME YOU'RE SAYING IS THAT, YOU CAN BE A BUSINESS ASSOCIATE BECAUSE YOU DO A BUSINESS ASSOCIATE TRANSACTION. AND IT COULD BE GOING BACK TO YOUR MERCY EXAMPLE, IT COULD BE THE QUALITY ASSURANCE FUNCTION. BUT IF YOU WANT TO--IF YOU HAVE AN INTEREST IN FINDING AND YOU WANT TO EXTEND THAT DATA SET BY COLLECTING ADDITIONAL INFORMATION WHICH YOU'RE THOT USING IF ARE YOUR HIPAA TRANSACTION, BUT WHICH WOULD BE USEFUL FOR THE RESEARCH EVEN THOUGH THE BUSINESS ASSOCIATE IS DOING THE SAME THING WITH THE DATA, IF THAT DATA WOULDN'T HAVE BEEN DISCLOSED FOR THE TRANSACTIONS THAT ARE PART OF THE BUSINESS ASSOCIATE AGREEMENT IT'S NOT ELIGIBLE FOR THIS EVENT? >> NO I WOULD SAY THE OPPOSITE, STEPHEN. I MEAN, NOT THAT I WOULD SAY, WHAT I THINK THE SUBCOMMITTEE MEANT IS THAT ONCE THE AUTHENTIC BUSINESS ASSOCIATE AGREEMENT RELATIONSHIP HAS BEEN ESTABLISHED, THEN, REMEMBER THE B. A. A. WILL THEN SAY TO THE NONCOVER THE EBTITY THAT ANY OF THE PHI IT RECEIVES FROM THE COVEREDDENTITY IT WILL FOR THAT PURPOSE IT WILL BE BOUND BY HIPAA. THAT'S WHAT THE B. A. A. WILL SAY. SO THAT WOULD INCLUDE NOT ONLY THE INITIAL BOLUS OF DATA BUT ANY ADDITIONAL DATA. SO WHAT WE'RE SAYING IS THAT YOU COULD--UNDER THIS INTERPRETATION, THIS RECOMMENDATION, THE COVEREDDENTITY COULD SEND AFTER THE B. A. A. FUNCTION HAS BEEN FINISHED, IT COULD SEND DATA OVER AS LONG AS THE ACTIVITY WAS SOMEHOW REASONABLY CONNECTED TO THE ORIGINAL BUSINESS ASSOCIATE ACTIVITIES. THEN THEY COULD JOINTLY TAKE--I. >> I THINK THAT'S CONFUSING. I DON'T KNOW HOW TO MAKE IT CLEAR. IT MAY JUST BE CONFUSING. SO YOU NEED TO ESTABLISH THE B. A. A. UNDER THE AUSPICES OF A LEGIT SET OF TRANSACTIONS. ONCE IT'S ESTABLISHED YOU CAN'T RELY ON HIPAA COVERAGE FOR THE B. A. A. FOR EVERYTHING YOU DO. YOU CAN'T USE THEM ASA AN OPEN RESEARCH COLLABORATOR BECAUSE THEY'RE UNDER A B. A. A. EVEN THOUGH THE B. A. A. IS LEGITIMATE. >> RIGHT. >> AND YOU DON'T--BUT I DON'T HAVE TO LIMIT IT TO JUST THE MATERIAL YOU USED FOR THE B. A. A. >> RIGHT. >> SO IT'S SOMEWHERE IN BETWEEN THERE AND I THINK DEFINING THAT IS KIND OF HARD. >> I THINK IT IS TOO. I THINK THAT IN THE ACTUAL GUIDANCE DOCUMENT WHICH WE CAN LOOK AT AND DUE COURSE, WE TALK ABOUT THE RELITTEDNESS TO THE UNDERLYING BUSINESS ASSOCIATE ACTIVITY, LEGITIMATE BUSINESS ASSOCIATE ACTIVITY, LOOK, HERE'S THE PROBLEM, I MEAN IS IT A DEFINITIONAL PROBLEM? YES, THE PROBLEM IS THAT THAT ALTERNATIVE IS TO SAY, WHICH WE COULD SAY, I MEAN YOU GUYS COULD RECOMMEND IS THAT B. A. A. SHOULD NOT BE ELIGIBLE, YOU KNOW TO TAKE ADVANTAGE OF THE EXEMPTION WHICH WOULD ACCEPTED THEM BACK, IT'S NOT THAT THEY WOULD HAVE THE RESEARCH BUT THEY VALID TO HAVE THE FULL IRB PROTOCOL, WAIVER OF CONSENT AND WAIVER OF AUTHORIZATION. >> THAT'S NOT WHAT I'M PROPOSING. THIS MAKES ALL THE SENSE IN THE WORLD BUT THE QUESTION IS THE SCOPE OF THAT COVERAGE. >> RIGHT. >> SO WE DON'T WANT TO SAY, BECAUSE I DON'T THINK IT WAS INTENDED, THAT THEY BE EXCLUDED IN THEIR HIPAA COVERED ACTIVITIES. BUT WE ALSO DON'T WANT TO SAY THAT ONCE YOU ESTABLISHED A LEGITIMATE B. A. A. YOU CAN DO ANYTHING YOU WANT WITH THAT COMPANY. >> THAT'S RIGHT. >> SO I THINK WHERE PEOPLE ARE LOOKING FOR GUIDANCE AND WHERE I'M FRANKLY UNCLEAR IS WHERE YOU DRAW THAT LINE. AND I DON'T KNOW HOW TO GET IT, YOU KNOW--I'M ALMOST--I'M TEMPTED ALMOST TO TAKE THAT FIRST POSSIBILITY WHICH IS JUST LIMIT IT TO THE DATA YOU'RE ALREADY EXCHANGING FOR CLARITY BECAUSE I DON'T KNOW OTHERWISE HOW TO DEFINE IT AND AFTER ALL THESE ARE--THIS IS AN EXEMPTION. IT DOESN'T HAVE TO BE--THIS IS RESEARCH THAT CAN ALREADY BE DONE IT JUST NEEDS TO BE REVIEWED AN IRB. SO I DON'T KNOW. I THINK WE NEED TO--THERE'S SOME DANGER IN NOT HAVING A CLEAR RECOMMENDATION. RIGHTLY OR WRONGLY, YOU KNOW? >> SO THE THEOR SETHAT YOU THINK ROOTS APPROPRIATE FOR THE EXEMPTION TO APPLY WHENEVER THERE'S A BUSINESS ASSOCIATE AGREEMENT THAT SUBJECT TO ENFORCEMENT BY OCR, RIGHT? >> THAT'S RIGHT. >> SO MAYBE THAT'S THE WAY TO CLARIFY IT? ALTHOUGH MAYBE THAT'S WHERE THE CONFUSION IS. WHAT ARE THOSE SCENARIOS IN WHICH THE BUSINESS ASSOCIATE WOULD BE SUBJECT TO ENFORCEMENT BY OCR DIRECTLY AND WHERE WOULD THEY NOT BE, BUT THE AREAS WHERE THEY WOULDN'T BE SUBJECT TO ENFORCEMENT WE WOULD WANT TO TAKE OUT OF THE EXEMPTION, RIGHT? >> YEAH. >> YES. [LAUGHTER] EVERYTHING ABOUT THE BUSINESS ASSOCIATE ISSUE HERE IS EXTREMELY COMPLICATED AS I THINK EVERYONE IS RECOGNIZING. AND I THINK IT'S--YOU KNOW CERTAINLY WOULD BE VALUABLE TO HAVE SOME EXAMPLES AND I WOULDN'T BE ABLE TO ENDORSE WITHOUT FURTHER STUDY, AND WORK WITH OUR GENERAL COUNSEL BUT I THINK WHAT I SAID BEFORE, THE SUBCOMMITTEE STAGE, TOO IS THAT, YOU KNOW IT'S HELPFUL FOR US TO HAVE A LOT OF SMART THOUGHTFUL PEOPLE SUGGEST HOW WE SHOULD INTERPRET THINGS. AND SO, THAT'S--THAT'S HOW WE TAKE IT WHEN A RECOMMENDATION COMES IN AND WE THINK ABOUT WHETHER IT MAKES LEGAL SENSE, WHETHER IT'S POSSIBLE TO DO. SO, I CAN'T SAY RIGHT NOW FOR SURE THAT THE SCOPE OF THE COVERAGE OF THE BUSINESS ASSOCIATE--BE HAPPY TO GET-- >> LET METRICS JUST SAY A RIFF ON THIS 1 OF THE COMPLICATIONS HERE AND 1 OF THE REASONS NOT TO HAVE JUST A BRIGHT LINE TEST OF THE DATA THAT YOU SHIP OVER FOR THE B. A. A. PURPOSES, THOSE ARE THE ONLY DATA THAT CAN BE USED FOR THE EXEMPTION IS THE FOLLOWING AND THAT IS THAT IT ACTUALLY RELATES TO THE SIXTH POINT IN ALL OF THIS WHICH IS THE--THE DISTINCTION BETWEEN THE DIFFERENCE IN THE INTERPRETATION OF RESEARCH BETWEEN OCR AND OHRP. BECAUSE REMEMBER THAT OCR HAS A PRIMARY PURPOSE TEST FOR AN ACTIVITY AND THAT IS THAT--UNDER--FOR OCR'S PURPOSES, SOMETHING CAN BE RESEARCH AND OPERATIONS RESEARCH AND PUBLIC HEALTH OBSERVATIONS ALL AT THE SAME TOO AND SO TO UNDERSTAND LIKE, YOU KNOW WHAT IT IS, 1 LOOKS AT THE KIND OF PRIMARY PURPOSE OF IT. UNDER FOR OHRP, IF IT'S--IT'S EITHER RESEARCH OR NOT AND IT'S NOTHING ELSE. IT'S EITHER RESEARCH AND JURISDICTION ATTACHES OR NOT. SO WHEN YOU THINK ABOUT WHAT THIS IS, THE REASON TO TRY TO EXTEND THE EXEMPTION A LITTLE BIT ALTHOUGH I DON'T KNOW WHAT THE RIGHT ANSWER IS HERE IS THAT WHAT THE BUSINESS ASSOCIATE IS DOING FOR THIS KIND OF ADDITIONAL PURPOSE, IT MAY BE RESEARCH TO OHRP BUT IT MAY BE PURE OPERATIONS STILL OR PUBLIC HEALTH ACTIVITIES IN OCR'S VIEW. SO THE QUESTION WOULD BE DO WE WANT TO PENNALLIZE THEM BY NOT GIVING THEM ACCESS TO THE EXEMPTION WHEN THEY'RE ACTUALLY DOING SOMETHING THAT IS OPERATIONS UNDER THE HIPAA INTERPRETATION? >> SO BUT THEN THOSE EXAMPLES WOULD CLEARLY BE UNDER THE--THE EXISTING BUSINESS ASSOCIATE AGREEMENT? >> THEY WOULD, YEAH. >> I GUESS I'M STRUGGLING WITH GIVING A RECOMMENDATION. I MEAN MAYBE PART OF THIS IS THAT WE HAVE TO WORK WITH OCR TO WORK OUT ACTUALLY THE DETAILS OF THIS, BECAUSE, IT SEEMS TO ME WE'RE STRUGGLING. IT'S NOT CLEAR TO ME WHETHER THIS IS REGULATORY COMPLEXITY THAT WE JUST NEED TIME TO PARSE OUT OR WHETHER ACTUALLY THESE ARE THINGS WE DON'T KNOW? I'M BEGINNING TO FEEL LIKE IT MAY BE THE LATTER AND THEN WE SHOULD--BUT YOU KNOW AGAIN IT'S AN EXEMPTION SO PEOPLE WILL START USING IT. AND I THINK WE NEED TO--I GET ALL THE REASONS FOR WANTING IT TO BE BROADER AND I'M NOT ARGUING AGAINST THAT BUT I THINK WE NEED TO ARTICULATE, GIVE WARNING, THAT THESE THINGS ARE OKAY, CLEARLY UNDER THE EXEMPTION, THEN THERE'S THIS AREA WHICH HASN'T BEEN ESTABLISHED YET AND EITHER YOU CAN TALK TO OCR AND SEE IF YOUR PARTICULAR CASE WOULD BE COVERED UNDER HIPAA IN WHICH CASE YOU GET THE EXEMPTION OR WAIT FOR FURTHER GUIDANCE. I'M NOT SURE. >> SO I THINK IT'S HARD FOR US TO PARSE THIS, CERTAINLY HARD FOR ME TO PARSE IT. YOU'RE MUCH BETTER AT IT OBVIOUSLY, BUT AS A RESEARCH ORGANIZATION, DEALING WITH COVERED ENTITIES AND THEIR CONTRACTING DEPARTMENTS OKAY, SO YOU'RE JUST THIS PERSON SITTING IN THE CONTRACTING OFFICE OF A COVERED ENTITY AND BASICALLY, YOU DO NOT WANT TO TAKE ANY RISKS. YOU DON'T WANT TO DEAL WITH ANYONE THAT YOU CAN'T DEAL WITH UNDER A BUSINESS ASSOCIATE AGREEMENT. SO, IT BECOMES VERY DIFFICULT TO CONDUCT RESEARCH, EVEN IF THE 2 ORGANIZATIONS INVOLVED ACTUALLY WANT TO DO SO AND CAN DO SO IN VERY PRODUCTIVE AND PRODUCTIVE WAYS. IT BECOMES ACTUALLY DIFFICULT TO ENGAGE IN RESEARCH JOINTLY. BECAUSE THERE IS AN ASSUMPTION IN THE BUSINESS OFFICE THAT WE DON'T DEAL WITH PEOPLE AND TRANSFER PHI UNLESS WE CAN DO IT UNDER A B. A. A. BECAUSE OTHERWISE WE DON'T FEEL SAFE DOING IT. SO THIS KIND OF OPENS THE THIN EDGE OF THE WEDGE EVEN FURTHER BY SAYING, OKAY, SO WE CAN ONLY ENGAGE IN RESEARCH WITH ORGANIZATIONS FOR WHOM WE ALREADY HAVE A LEGITIMATE B. A. A. WE REALLY AREN'T GOING TO ENGAGE IN THIS FOR ANYONE WHOM WE CAN'T DO LEGITIMATE B. A. A. AND WOONS WE HAVE THE B. A. A. WE ARE GOING TO EXTEND IT AS FAR AS POSSIBLE BECAUSE THAT MAKES LIFE EASIER IN THE CONTRACTS OFFICE. SO IT DOES TROUBLE ME IN THE SENSE THAT IT'S ALMOST A KIND OF--A COMPETITIVE PROBLEM FOR ORGANIZATIONS THAT WOULDN'T NORMALLY WISH TO HAVE A B. A. A. OR BE COVERED UNDER A B. A. A. BUT WISH TO DO RESEARCH WITH A PROTECTED HIPAA COVERED ENTITY. SO JUST THINK ABOUT THAT SIMPLE MINDED PROBLEM. NOT A SUBTLE PROBLEM. >> SO SANDY CAN I JUST--YOU KNOW, THE OTHER THING ABOUT THIS IS THAT IT'S--IT'S AN EXEMPTION. IT'S NOT ENABLING REGULATION, SO, ANYTHING YOU COULDN'T DO NOW, YOU CAN'T DO UNDER THE EXEMPTION. SO ALL OF THE SCENARIOS THAT YOU--SO THIS WOULDN'T ENABLE ANYONE DE NOVO TO GO OUT AND GET A B. A. A. AND DO RESEARCH. IT ONLY SAYS IF YOU HAVE A LEGITIMATE BUSINESS ASSOCIATE AGREEMENT AND RELATIONSHIP AND DATA EXCHANGE PROCESS, YOU MAY NOT HAVE TO GO TO THE IRB. >> YEAH BUT THAT'S BIG. >> NO, NO, UNDERSTOOD. BUT IT'S NOT TELLING YOU, YOU CAN DO NEW THINGS, IT'S ONLY TELLING YOU THAT SOME OF THE THINGS YOU WERE DOING ALREADY, YOU MAY BE ABLE TO DO MORE EASILY. >> BUT MORE EASILY AND HUGE AND I MEAN SO--JUST THIS WEEK WE'VE BEEN DEALING WITH A COVERED ENTITY, WHO WANTS TO ENGAGE IN RESEARCH WITH US AND WHO IS BASICALLY INSISTING THAT WE SIGN A BUSINESS ASSOCIATE AGREEMENT AND WE'RE SCRATCHING OUR HEADS SAYING, GHEE, FIRST OF ALL WE DON'T REALLY WANT TO SIGN A BUSINESS ASSOCIATE AGREEMENT FOR EXACTLY THE REASONS THAT YOU MENTIONED AND SECONDLY, WE'RE NOT SURE IT'S APPROPRIATE IN THIS SITUATION. BUT THAT'S WHAT THEY'RE CONTRACTING OFFICE IS INSISTING ON SO IT MAY BE THAT WE EITHER DO THAT OR WE DON'T ACTUALLY ENGAGE IN COOPERATIVE RESEARCH. >> SO I DON'T THINK THOUGH, SO, YOU COULD DO THAT--YEAH, WELL YOU COULD DO THAT NOW, MEAN SINCE THESE AREN'T IN EFFECT ANYWAY, YOU COULD DO THAT NOW AND THE INSTITUTION WOULD HAVE TO PUT IT THROUGH THEIR IRB AND THEY COULD--I THINK IT'S PROBABLY BEST PRACTICE--BUT IT'S BEST PRACTICE IF YOU CALL IT A BUSINESS ASSOCIATE AGREEMENT OR NOT IT'S BEST PRACTICE TO CONTRACTUALLY BIND YOUR CONTRACTORS OUR SUBCONTRACTORS INTO YOUR DAT PROTECTION PLAN. THAT DOESN'T MAKE THEM A BUSINESS ASSOCIATE BY HIPAA AND THAT'S WHAT YOU ARE REALLY TALKING ABOUT. I MEAN IF YOU DID IT TODAY THAT,'S WHAT IT WOULD BE AND YOU WOULD STILL NEED IRB REVIEW. >> I WOULD ARGUE THAT I THINK THAT THAT'S VERY CONTEXT AND LOCATIONS SPECIFIC I THINK THERE ARE THOSE THAT ARE AROUND UNIVERSITY EXPTION COVERED ENTITIES WHERE THERE'S ROUTINE CORPORATION AND SO I THINK IT REALLY DEPENDS ON WHERE YOU ARE TO SAY THAT PEOPLE ARE GOING TO BE RELUCTANT TO ENGAGE IN RESEARCH. I KNOW OUR FACILITY DOES REACH OUT TO ALL THE OTHER UNIVERSITIES AND IT'S BEEN A VERY RICH EXPERIENCE. >> DEALING WITH COUNTY SYSTEM A TOTALLY DIFFERENT. >> SO I JUST--I MEAN I THINK EVERYTHING THAT I'M HEARING SEEMS CORRECT BUT THE SORT OF SUBTEXT SEEMS WRONG SO THAT THERE'S NOTHING THAT THIS--THERE'S NOTHING THAT THIS EXEMPTION MAKES HARDER. IT ONLY MAKES THINGS EASIER SO THERE'S NOTHING UNDER OUR INTERPRETATION OR ANYTHING ELSE THAT WILL CHANGE THE RULES SO THAT IT'S HARDER TO DO RESEARCH OR THERE'S SOMETHING YOU WANT TO DO NOW THAT YOU WON'T WANT TO DO UNDER THE EXEMPTION. SO I THINK SANDY EVERYTHING YOU RAISE ABOUT THE BARRIERS AND MAYBE MAKING IT EASIER WILL MAKE NEW THINGS ATTRACTIVE TO DO IT BUT I THINK THAT NEEDS TO BE THE PERSPECTIVE. THERE'S NOTHING IN THE EXEMPTION THAT MAKES ANYTHING MORE DIFFICULT AND ALL THE COMPLEXITIES WERE THERE TO BEGIN WITH. SO, MAYBE HAVING THAT OPTION WILL OPEN THE IDEA OF RESEARCH TO PEOPLE WHO WANT TO TAKE ON THE COMPLEXITIES OF IRB REVIEW. BUT THAT'S A POSITIVE THING IT DOESN'T TAKE ANYTHING AWAY TO HAVE THE EXEMPTION. >> I'M TALKING ABOUT--MEAN TO BE BLUNT ABOUT IT A COMPETITIVE DISADVANTAGE, THAT THE NOTION IF IF YOU HAVE A B. A. A. AND ENACTED A B. A. A. YOU CAN ALSO DO RESEARCH, BUT IF YOU DON'T, YOU CAN'T, IS FROM A BUSINESS PERSPECTIVE A COMPETITIVE DISADVANTAGE THAT'S WHAT I'M SAYING AND I'M JUST WONDERING WHETHER THAT'S APPROPRIATE. I AGREE WITH YOU COMPLETELY. YOU'RE NOT MAKING ANYTHING MORE DIFFICULT BUT YOU'RE MAKING SOMETHING RELATIVELY MORE DIFFERENT. >> IT'S JUST A FASCINATING PERSPECTIVE. >> IT'S JUST DIFFERENT. >> NEVER OCCURRED TO ME. >> SO LET ME GIVE YOU THE 2 ALTERNATIVES BASICALLY. I DON'T KNOW BECAUSE IN TERMS OF THIS, IF YOU THINK THAT IF THE--IF THE COMMITTEE THINKS, I'LL CHANGE IT ANYWAY YOU WANT ME TO CHANGE IT, I DON'T HAVE A DOG IN THE FIGHT. SO JUST TELL ME WHAT YOU WANT BUT AS I SEE IT THERE ARE 2 ALTERNATIVES HERE, SO 1 ALTERNATIVE IS TO SAY THAT WHEN THERE'S LEGITIMATE B. A. A. RELATIONSHIP, THE DATA THAT ARE EXCHANGED FOR THE PURPOSE OF THE B. A. A. RELATIONSHIP CAN BE SUBJECT TO AND CAN TAKE ADVANTAGE OF THE HIPAA XEMPLEGZ. THE OTHER ALTERNATIVE IS MORE EXPANSIVE WHICH SAYS, IF THERE IS A LEGITIMATE B. A. A. ACTIVITY, 1 CAN EXCHANGE ANY OF THE DATA AS LONG AS THE RESEARCH ACTIVITY IS CONNECTED AND REASONABLY RELATED TO THE UNDERLYING B. A. A. ACTIVITY AND THEN THEY CAN STILL TAKE ADVANTAGE OF THE 2 ENTITIES BECAUSE THEY'LL STILL TAKE ADVANTAGE OF THE HIPAA EXEMPTION. IESM HAPPY TO WRITE EITHER 1. >> COULD WE ARTICULATE THE SECOND TO SAY THE ADDITIONAL DATA EXCHANGE COULD BE INTERPRETED AS FALLING UNDER THE HIPAA CATEGORIES? MAKE--THERE NEEDS TO BE A TEST I THINK UNDER THAN RELATEDNESS FOR THE DATA. ANYWAY THINK ABOUT IT I DON'T KNOW THE ANSWER EITHER. >> ANYWAY, YOU KNOW IF YOU HAVE BRIGHT IDEAS DURING THE DAY LET ME KNOW BECAUSE I'M HAPPY TO WRITE IT ANYWAY. >> I HOPE THIS OKAY WITH YOU BUT IN THE INTEREST OF BRIGHT IDEAS, I THINK WE SHOULD TAKE A 15 MINUTE BREAK. >> BREAK? [LAUGHTER] >> GET MORE COFFEE AND COME BACK AT 10 OF 11. >> SOUNDS GOOD. >> AND WE WILL START ON TIME BECAUSE AS YOU CAN SEE, THIS IS A COMPLICATED AND WE ONLY HAVE SO MUCH TIME. THANK YOU. [PROGRAM IS ON A SHORT BREAK ] >> LET RECONVENE. MARK? >> OKAY, SO JUST TO CONCLUDE THE POINT TO DISCUSSION, I HAD SIDE BARS WITH MANY OF YOU, I HAD ABOUT 10 PEOPLE IN THE INTERIM, WHY DON'T I SUGGEST THIS IN TERMS OF--BECAUSE WE WOULD LIKE TO GET THIS, ASSUMING YOU WOULD THINK IT'S READY WE WOULD LIKE TO GET IT PASSED TOMORROW, BUT WHAT I DO WITH THIS IS THE FOLLOWING IF IT MEETS WITH PEOPLE'S,A PROVAL I COULD LIMIT THIS TO SAY THAT PHI THAT YOU SHARED FOR LEGITIMATE BUSINESS ASSOCIATE PURPOSE COULD BE THE SUBJECT OF RESEARCH AND WE KNOW THAT'S THE CASE. IN TERMS OF THEN POINT OUT THE SECOND THING IS TO POINT OUT THE HELT CARE OPERATIONS OPERATIONS AND OTHER ACTIVITIES UNDER THE OCR DEFINITION ARE BROADER THAN RESEARCH ACTIVITIES SO THAT 1 CAN SHARE THESE KINDS OF THINGS FOR THE DATA FOR BUSINESS OPERATIONS BROADLY SPEAKING AND THEN THE THIRD THING IS TO SAY THAT WHETHER THE--WHETHER AN ACTIVITY THAT IS BUSINESS OPERATIONS, MIGHT FALL OR NOT UNDER THIS EXEMPTION WOULD REALLY BE A QUESTION FOR INDIVIDUAL AND COVERED ENTITIES TO MAKE A DECISION ON THEIR OWN AS TO WHETHER THE EXEMPTION APPLIES OR NOT. I WILL WRITE IT MORE ELEGANTLY THAN THAT BUT THAT'S THE BASIC IDEA? >> COMMENTS? >> NO, I THINK THAT'S GOOD, WITH MAYBE MAKING EXPLICIT IS THE TEST IS WHETHER IT FALLS UNDER OCR'S JURISDICTION OR NOT? >> YEAH, YEAH, OKAY. >> OKAY, NOW I THINK THIS IS SOMEWHAT EASIER, THIS IS A VERY DIFFICULT ISSUE. LET ME SHOW YOU--OH SHOOT. LET ME SHOW YOU WHY THIS IS IS SOMEWHAT DIFFICULT, LUCKILY I CARRY A HAND KER CHIF LIKE SOME GUY FROM THE 1950S. [LAUGHTER] LET ME SHOW YOU WHY THIS IS A DEFINITION. LET ME GO BACK TO THE DEFINITION. OKAY. THIS IS THE--SORT OF STEM PHRASE HERE, SECONDARY RESEARCH FOR WHICH CONSENT IS NOT REQUIRED. SECONDARY RESEARCH USES IDENTIFIABLE PRIVATE INFORMATION OR IDENTIFIABLE BIOSPECIMENS IF AT LEAST 1 OF THE FOLLOWING CRITERIA IS MET. SO IT SAYS IDENTIFY PRIVATE INFORMATION OR IDENTIFIABLE BIOSPECIMEN FIST 1 OF THE FOLLOWING CRITERIA IS MET. AND THEN YOU LOOK AT 3 AND IT SAYS RESEARCH INVOLVES ONLY INFORMATION COLLECTION AND ANALYSIS INVOLVING INVESTIGATOR'S USE OF IDENTIFIABLE HEALTH INFORMATION, ET CETERA. THE DEBATE FOR WHAT IT'S WORTH WAS WHETHER THE USE OF THE PHRASE IDENTIFIABLE BIOSPECIMENS IN THE STEM WOULD MEAN THAT THE USE OF IDENTIFIABLE BIOSPECIMENS IF IT FIT WITHIN 3 AS WELL WOULD ALSO BE POTENTIALLY EXEMPT UNDER THIS SO CALLED HIPAA EXEMPTION. THERE'S ALSO A SOMEWHAT MISLEADING PHRASE IN THE PREAMBLE, IN THE COMMENTARY WHICH INDICATED THIS 3, SUBSECTION 3 WAS AVAILABLE OR IS AVAILABLE FOR THE USE OF IDENTIFIABLE BIOSPECIMENS WHICH I REALIZE LATER IN TALKING WITH OCR, WITH OHR P WAS UNINTENTIONAL EVEN THOUGH IT SAYS IT WAS NOT MEANT TO BE THAT. SO THEN THE QUESTION BECOMES, LET ME JUST GET THROUGH BACK TO WHERE WE STARTED. , SO THEN THE QUESTION BECOMES WHETHER GIVEN THIS AMBIGUITY, ALTHOUGH THE LITTLER ARGUMENT IS THAT NUMBER 3 TALKS ABOUT INFORMATION DOESN'T TALK ABOUT BIOSPECIMENS AS WELL SO ARE IDENTIFIABLE BIOSPECIMENS ABLE TO BE USED FOR SECONDARY RESEARCH UNDER THIS EXEMPTION OR NOT. THAT'S THE QUESTION. AND THE RECOMMENDATION AFTER A LOT OF DISCUSSION FROM THE SUBCOMMITTEE IS FOR A VARIETY OF LEGAL POLICY AND PRAGMATIC REASONS WE THINK THE HIPAA EXEMPTION SHOULD NOT BE READ FOR AVAILABLE RESEARCH INVOLVING IDENTIFIABLE SPECIMENS, IT SHOULD BE LIMITED TO THE USE OF THE IDENTIFIABLE DATA BUT NOT INVOLVE USE OF IDENTIFIABLE BIOSPECIMENS AND JUST SO YOU KNOW WHY WE MADE THIS RECOMMENDATION, APPLYING THE EXEMPTION ONLY TO THE IDENTIFIABLE INFORMATION IS THE MOST CONSISTENT WITH THE ACTUAL LITERAL READING OF ROMANET 3 WHICH ONLY TALKS ABOUT INFORMATION EVEN THOUGH THE PRECEDING INFORMATION TALKS ABOUT INFORMATION OR BIOSPECIMENS. SO THAT'S 1 REASON. THE SECOND REASON IS THAT IF WE READ THE--GIVEN ALL THAT'S GONE ON, THE WHOLE DEBATE ABOUT WHETHER UNIDENTIFIED BIOSPECIMENS SHOULD BE REGARDED AS HUMAN SUBJECTS OR NOT IN THE NPRM ALL OF THESE THINGS THAT THE VARIOUS CASES THAT WE HAVE--THAT WE'VE TALKED ABOUT FOR EXAMPLE THAT HAVE A SUPI CASE IN THESE MEETINGS. WE THINK READING THE HIPAA EXEMPTION OF IDENTIFYING BIOINFORMATION SPECIMENS WOULD PROTECT THE SPECIMENS THAT WERE OFFERED AND TALKED ABOUT IN THE COMMENTARY AND THE FINAL RULE. SO WE THINK THAT NOT READING THE EXEMPTION TO IDENTIFIABLE BIOSPECIMENS WOULD BE MORE PROTECTIVE OF THE THOSE INDIVIDUALS FOR WHONL THE IDENTIFIABLE BIOSPECIMEN VS BEEN TAKEN. SO IT'S NOT THAT YOU CAN'T USE THEM BUT YOU WOULD HAVE TO GO TO AN IRB WITH THE FULL APPLICATION FOR A WAIVER OF CONSENT AND AUTHORIZATION, AND THE THIRD THING IS THIS, WE ASKED OURSELVES, WHY WOULD ANYONE WANT TO TAKE ADVANTAGE OF, IF WE APPLIED AND RECOMMENDED THIS EXEMPTION APPLY TO THE USE OF IDENTIFIABLE BIOSPECIMENS, WHAT ARE SCIENTISTS GOING TO USE THIS FOR. WELL, IN MOST CASES, ON A MASS SCALE, THEY WOULD TO USE THESE ENOUGH SPECIMENS TO DO GENETIC SEQUENCING, THAT'S WHAT THEY WANT TO DO. WHICH THEN TAKES YOU BACK INTO OUR .7 TODAY FOR REGARD FOR OTHER LAWS BECAUSE IF THEY DID THAT, THEY WOULD RUN UP AGAINST 25 DIFFERENT STATE LAWS WHICH HAVE INFORMED CONSENT REQUIREMENTS OR IRB APPROVAL REQUIREMENTS TO DO GENETIC TESTING ON RESIDENTS ON DNA EXTRACTED FROM RESIDENTS OF THOSE STATES. SO YOU WOULDN'T--YOU WOULD STILL BE BACK IF YOU WOULD TAKE ADVANTAGE OF THE HIPAA EXEMPTION FOR BIOSPECIMENS IF YOU WANT TO DO GENETIC SEQUENCING AND THAT KIND OF RESEARCH OR EVEN EXOMIT SEQUENCING, YOU WOULD BE BACK INTO THE PICKLE, BECAUSE YOU HAVE TO OBEY STATE LAWS OF NEEDING EITHER CONSENT OR IRB APPROVAL. SO, WE DON'T THINK AT THE END IT MAKES THAT MUCH DIFFERENCE AND THE STATES WHERE THE 25 OR 25 STATES IN WHICH THEY HAVE THESE GENETIC TESTING INFORMED CONSENT LAWS AND DISCLOSURE LAWS THOSE TEND TO BE STATES IN WHICH MOST OF THE GENETIC RESEARCH IS BEING DONE. SO THE--SO PRACTICALLY SPEAKING IT DOESN'T MAKE A LOT OF SENSE--IT'S NOT GOING TO HELP MANY PEOPLE TO EXTEND THIS TO COVER IDENTIFIABLE BIOSPECIMENS. SO THOSE ARE THE 3 REASONS WE RECOMMEND THIS. SO WE BELIEVE THAT READING THE HIPAA EXEMPTION TO INCLUDE IDENTIFIABLE BIOSPECIMENS WOULD BE INCONSISTENT WITH PLAIN LANGUAGE AND POLICY CLAIMS AND FORMAL CLARIFICATION BE PUBLISHED IN THAT SPIRIT. >> THANK YOU. COMMENTS? >> LARRY? , HAD JUST SORT OF ECHOING WHAT YOU SAID MARK AS YOU KNOW ON OHRP ON OUR UNDERSTANDING GET INTO BOTH TERMS IN THE LEAD-IN BECAUSE SOME OF THE SUBROM SUBROM--SUBROM ANETS INVOLVED WORDING OR THE OTHER SO THIS PARTICULAR SUBSECTION WAS RELATIVELY CLEAR IN TERMS OF NOT MENTIONING THE BIOSPECIMEN THING. BUT ANYWAY, OUR UNDERSTANDING OF WHAT WAS INTENDED, WHAT WE WERE TRYING TO DO WAS IN FACT, THAT WE ARE NOW PLANNING ON ON BIOSPECIMENS TO BE COVERED BY THIS AND IT WAS CONSISTENT AS A POLICY MATTER IN TERMS OF OUR BED UNDERSTANDING OF HOW HIPAA WORKED ON IT, IT WOULD HAVE BEEN UNDER HIPAA IN TERMS OF THE BIOSPECIMEN ITSELF FOR THOSE REASONS JUST IN CASE PEOPLE CARE, WHERE THE POLICY WAS COMING FROM, WHEN IT WAS DRAFTED IS CONSISTENT WITH THE OUTCOME YOU'RE REACHING. >> GREAT. THANK YOU. LET'S MOVE ON. >> OKAY. SO ISSUE 4 IS THE USE OF BIOSPECIMENS THAT ARE ADDED TO THE DATABASE OR REPOSITORY AS THE PROJECT BEGINNING, ACTUALLY SHOULD JUST BE INFORMATION NOT SPECIMENS THAT'S AN ARTIFACT OF SOMETHING REFIOUS, SO CAN THE HIPAA EXEMPTION BE USED TO APPLY TO INFORMATION COLLECTED AFTER THE SECONDARY RESEARCH PROJECT FOR WHICH THE HIPAA WAS SOUGHT AND GAINED HAS BEGUN. SO I HAVE A HANDY GRAPHIC HERE. [LAUGHTER] SO IF WE HAVE A MERCY HOSPITAL DATABASE AND THESE ARE JUST POINTS IN TIME, THE INVESTIGATOR BEGINS RECORDS RESEARCH INVOLVING MERCY PHI, USING THE HIPAA EXEMPTION MEANING THEY HAVE A WAIVER OF AUTHORIZATION FROM THE PRIVACY BOARD OR IRB OR ELSEWHERE THAT MERCY IS RESPECTING AND THEY DO THE RESEARCH AT THIS TIME, USING THE DAILY BASIS THEA FROM THE DATA PHI DATABASE FROM MERCY, AND THEN PHI IS ADDED TO MERCY'S PHI DATA DATABASE AFTER RECORDS RESEARCH BEGAN WHICH THAT THE PHI IS JUST THE ENTIRE MEDICAL RECORDS SYSTEM OF MERCY MEDICAL CENTER, CAN THIS EXEMPTION INCLUDE THIS STUFF AS WELL? THE STUFF IN THIS GAP PERIOD HERE? AND THEN GOING FORWARD, CAN THE DATABASE BE SUPPLEMENTED GOING FORWARD UNDER THE HIPAA EXEMPTION. SO OUR RECOMMENDATION IS THAT THE DATA COLLECTED BY DATABASES THAT ARE SUBJECT TO THE HIPAA PRIVACY RULE THAT ARE CONTINUOUSLY COLLECT PRIVATE INFORMATION SHOULD BE ELIGIBLE FOR THE HIPAA EXEMPTION ENCLUEDING DATA COLLECTED AFTER A SECONDARY RESEARCH PROJECT FOR WHICH THE IPT GREATERRA EXEMPTION IS SOUGHT AND BEGUN. IN OTHER WORDS, AFTER THAT POINT IN TIME, THE--THE TYPES OF SECONDARY RESEARCH OR THE SECOND BULLET POINT FOR WHICH INVESTIGATORS WILL LIKELY SEEK TO MAKE USE OF THE HIPAA EXEMPTION WILL INCLUDE LONG-TERM MEDICAL RECORDS, OR SOCIAL SERVICES AND REVIEW STUDIES IN WHICH THEY USE PHI THAT DOES NOT EXIST AND WOULD BE ADDED TO MEDICAL CLIENT RECORDS OR AT SOME POINT IN THE FUTURE WHILE THE SECONDARY RESEARCH IS ONGOING, THE PREAMBLE THAT IS THE COMMENTAR TOW THE ADOPTION CONFIRM THIS IS UNDERSTANDING KNOWING THAT UNLIKE--THIS IS A QUOTE FROM THE COMMENTARY, UNLIKE THE PRE-2018 RULES EXEMPTION THE FINAL RULE HAS NO REQUIREMENT THAT THE INFORMATION MUST BE PREEXISTING AT THE TIME THAT THE INVESTIGATOR BEGINS A PARTICULAR RESEARCH STUDY. AND REMEMBER THOUGH THAT THIS INCLUDING PROSPECTED INTERVENTIONS OR PROSPECTIVE COLLECTIONS OF DATA THAT WOULD VARY FROM THE COLLECTIONS THAT WOULD OCCUR ANYWAY. UNDER OTHER AUTHORITY LIKE IN TREATMENT FOR EXAMPLE, OKAY? >> SO QUESTIONS OR CONCERNS? >> I MEAN I THINK THAT'S ENTIRELY CONNIVITIENT BY HIPAA SO THAT'S PROTECTION THAT'S SUFFICIENT. MAKES A LOT OF SENSE. >> OKAY. THIS POINT WE'VE ACTUALLY BEEN OVER ALREADY AND THAT IS THAT, YOU KNOW WE FELT IT WAS INCUMBENT ON US ON SACHRP, TO ADVICE SACHRP, AND THEN WE RECOMMEND THAT SACHRP ADVISE THE PUBLIC AND SECRETARY IN PARTICULAR AS TO WHY THIS IS THIS PRESENCE OF HEALTHCARE OPERATING GLOBALLY RAIGDZS AND PUBLIC HEALTH ACTIVITIES REFERENCED IN THIS EXEMPTION WHEN THE DEFINITIONS OF RESEARCH ARE WORD FOR WORD THE SAME SO WHY ISN'T THERE THERE BROAD KNOWED DEFINITION AND THE REASON AS I SAID BEFORE, AND THIS IS BASED ON OUR CONVERSATIONS WITH MARISSA AND OTHERS AND OCR AND OTHERS AND THAT AN ACTIVITY IS RESEARCH UNDER THE COMMON RULE, BUT NOT UNDER HIPAA WHEN THE PRIMARY ACTIVITY, THE PRIMARY PURPOSE OF THE ACTIVITY UNDER HIPAA IS OPERATIONS OR PUBLIC HEALTH ACTIVITIES AND RESEARCH IS A SUBSIDIARY PURPOSE. SO THERE'S THE SINGLE TEST UNDER THE BINARY TEST UNDER TD COMMON RULE THERE'S PRIMARY PURPOSE TEST UNDER HIPAA AND THAT IS WHY THAT EXPLAINS WHY IT WAS NECESSARY FOR THE DRAFTERS OF THE FINAL RULE TO INCLUDE THIS REFERENCE TO OPERATIONS AND SURVEILLANCE ACTIVITIES AND THERE ARE A LOT OF ACTIVITIES EVEN ASIDE FROM THAT THAT ARE OPERATIONS FOR XMPLE, THE COLLECTION OF REAL WORLD EVIDENCE THAT'S ALMOST INDISTINGUISHABLE FROM RESEARCH ANYWAY. SO, IT'S--THIS IS WHY. AND OUR PURPOSE IN ADD THANKSGIVING IN AND YOU CAN SEE THERE'S A LONGER DESCRIPTION IN THE TEXT OF THE PROPOSED GUIDANCE IS REALLY JUST TO EXPLAIN TO THE PUBLIC THAT IS THE PUBLIC THAT READS THIS STUFF, AS TO WHY THIS--THE LIMITED GROUP OF THE PUBLIC IS AS CONCERNED ABOUT THIS AS WE ARE. IN THIS ROOM, TO EXPLAIN TO THEM WHY THERE IS THAT--THOSE ADDITIONAL PHRASES ARE IN THE REGULATION. >> CONCERNS OR QUESTIONS? >> IS THERE GUIDANCE FOR HOW YOU IMPLEMENT THE PRIMARY PURPOSE TEST. >> WE HAVEN'T SAID SPECIFICALLY IF IT'S 51% OR IF IT'S--I THINK THAT WE--THE GUIDANCE WE'VE DONE ON THIS TOPIC HAS BEEN ABOUT WHAT YOU DO WHEN THE PRIMARY PURPOSE CHANGES AND HOW YOU NEED TO START TREATING IT DIFFERENTLY IF YOU'RE A PRIMARY PURPOSE CHANGES. BUT WE HAVEN'T GIVEN SPECIFIC GUIDANCE ON HOW YOU DETERMINE WHAT THE PRIMARY PURPOSE IS AT THE OUTSET. >> SO I DON'T KNOW HOW TO WRITE THE GUIDANCE. I WILL SAY THAT IN ANOTHER CONTEXT THERE'S DISCUSSION WHICH IS NOT EXPLICITLY TO DETERMINE PRIMARY PURPOSE BUT THERE'S RELEVANT, I THINK DISES DISES--DISCUSSION ABOUT WHO THE EXPECTED USERS ARE FOR WHAT PURPOSE. AND SO, THERE'S DISCUSSION ABOUT THE EXPECTATION THAT THE PRIMARY PURPOSE IS FOR THE PEOPLE WHO ARE RESPONSIBLE FOR MANAGING SUPERVISING OR MAKING DEDECISIONS ABOUT A PARTICULAR AREA OF ACTIVITY OR REGULATING THAT ACTIVITY. AND THAT'S SORT OF--POINTS TOWARD THIS IS A PRIMARY PURPOSE VERSUS A PRIMARY PURPOSE OF PRODUCING GENERALIZABLE KNOWLEDGE. IT DOESN'T SAY THAT YOU CAN'T PUBLISH THIS, PUBLICATION DOES NOT DETERMINE PURPOSE. BUT IT'S POINTING TOWARD THE USERS OF THE ACTIVITY AND THE USES OF OF THE INFORMATION. SO I JUST THINK THAT THIS PRIMARY PURPOSE THING, I KNOW IS SOMETHING I WILL BE WRESTLING WITH. AND I'M LOOKING FOR SOME GUIDANCE ON HOW TO DO IT RIGHT OR AT LEAST SENSIBLY RIGHT. >> IT'S ON MY LIST. >> OKAY. FOR NUMBER 6, THIS IS THE ISSUE OF USING THIS EXEMPTION IN COMBINATION OF WITH OTHER EXEMPTIONS THAT ARE AVAILABLE UNDER THE COMMON RULE FOR USE OF IDENTIFIABLE DATA. SO I HAVE A HANDY EXAMPLE HERE WHICH IS MERCY HOSPITAL WITH AN INVESTIGATOR AND PHI, OBVIOUSLY THEY CAN USE AND TAKE ADVANTAGE OF THE HIPAA EXEMPTION WITHIN MERCY HOSPITAL. AND THEN WE HAVE THE CENSUS BUREAU OVER HERE AND THE PUBLICLY AVAILABLE DATA. SO BEFORE INITIATING THE RESEARCH, THE INVESTIGATORS WILL TAKE ADVANTAGE OF THE HIPAA EXEMPTION AND SHE OR SHE IS ALSO GOING TO SEEK A WAIVER OF HIPAA AUTHORIZATION FROM THE PRIVACY BOARD OR IRB BECAUSE AS I'VE SAID BEFORE THE HIPAA JURISDICTION IS--APPLIES AND YOU HAVE TO HAVE A LEGAL BASIS UNDER HIPAA TO USE THE INFORMATION INTERNALLY WITHIN MERCY HOSPITAL, SO THAT'S CONSIST WENT EVERYTHING WE'VE SAID BEFORE. NOW THE QUESTION IS, CAN YOU INVESTIGATOR USE THE CENSUS BURRO'S INDIVIDUALLY IDENTIFIABLE INFORMATION AS PART OF THE RESEARCH PROJECT INVOLVING PHI, IF USE OF THE PHI RELIES ON THE HIPAA EXEMPTION. SO CAN THEY--CAN HE OR SHE BRING THIS INFORMATION INSIDE THE COVERED ENTITY? CAN THEY USE AND RESEARCH WITHOUT IRB APPROVAL? WE REGARD THIS AS BEING PERMITTED SO THAT 1 CAN USE--1 CAN MERGE DATA THAT ARE--THAT ARE EXEMPTION. THE USE OF WHICH FOR RESEARCH IS EXEMPT UNDER A NUMBER OF EXEMPTIONS 1 CAN USE THE MERGE ON DO DATA RECOMMENDATIONS THAT'S THE POINT. >> AND THE PROJECT STILL BE AN EXAMPLE. >> AND THE PIECE OF THE PROJECT--ACTUALLY THE ENTIRE PROJECT WOULD BE EXEMPT AND THE PIECE OF THE PROJECT THAT WOULD BE UNDER THE HIPAA EXEMPTION WOULD CONTINUE TO BE EXEMPT. DOES THIS MAKE SENSE? >> YES BECAUSE THE WHOLE PROJECT WOULD BE EXEMPT BECAUSE ALL THE DATA GOING INTO IT HAVE A SEPARATE BASIS FOR AN EXEMPTION. SO THIS IS NOT SAYING THAT ANYONE CAN USE DATA THAT OTHERWISE WOULD NOT BE ELIGIBLE FOR AN EXEMPTION. THAT'S NOT THE RECOMMENDATION, IT'S ONLY DATA THAT WOULD OTHERWISE, EACH INDEPENDENTLY WOULD BE ELIGIBLE FOR AN EXEMPTION. YOU COULD MERGE THEM TO USE IN 1 RESEARCH PROJECT WHICH ITSELF WOULD BE EXEMPT. SO THE LOGICAL EXTENSION OF THIS IS IT'S BEYOND THIS PARTICULAR EXEMPTION. IT'S INTERPRETING EXEMPTIONS AS BEING ABLE TO APPLY, IF YOU CAN--COVER A PROJECT TO MULTIPLE EXEMPTIONS IT REMAINS EXEMPT. IT DOESN'T HAVE TO FIT UNDER 1 GENERAL-- >> EXACTLY. EXACTLY. EXACTLY. IT IS A WEIRD EXAMPLE. THERE ARE OTHER EXEMPTIONS, I MEAN ... SO HERE'S THE RECOMMENDATION, THE HIPAA EXEMPTION SHOULD BE MADE AVAILABLE FOR USE IN OTHER RULE AND EXEMPTIONS THAT COLLECTIVELY RESEARCH A PROJECT FROM COMMON RULE REQUIREMENTS. IF AN INVESTIGATOR IS PREPARING A RESEARCH STUDY IN WHICH 1 SET OF DATA IS ELIGIBLE FOR DATA AND THE REMAINING DATA ARE ELIGIBLE FOR XESMS YOU SHOULD'RE UNDER THE COMMON RULE,ED STUDY SHOULD PROCEEDOT COMMON RULE BASIS BALL AWZ DATA INDEPENDENTLY MEET AT LEAST 1 EXEMPTION OF CRITERIA. AN EXAMPLE WE GIVE HERE IS A RESEARCH PROJECT USING P, I FROM A MEDICAL RECORDS OF A COVERED ENTITY AND USING GOVERNMENT RECORDS CONTAINING ADDITIONAL IDENTIFIABLE INFORMATION OPEN TO THE PUBLIC UPON REQUEST. SO THAT'S THE RECOMMENDATION, OKAY? AND NOW I WILL MOVE ON TO THE LAST POINT WHICH IS THE CONSIDERATION OF OTHER LEGAL REQUIREMENTS, SO HERE WE HAVE, I THINK--THIS WILL BE OBVIOUS BASED ON EVERYTHING THAT WE'VE TALKED ABOUT BEFORE. HERE WE HAVE MERCY HOSPITAL AND INVESTIGATOR, WE HAVE A WAIVER PERMITTING USE OF THE PHI, UNDER THE COMMON RULE SO THIS INVESTIGATOR UNDER THIS EXAMPLE HAS--IS DOING RESEARCH USING PHI WITHIN HIS OR HER COVERED ENTITY, MERCY HOSPITAL, THEY HAVE--THE PHI THEREFORE QUALIFY FOR THE USE OF THE PHI QUALIFY FOR THE HIPAA EXEMPTION, THERE IS A WAIVER OF AUTHORIZATION IN PLACE FOR USE OF THE SAME DATA GRANTED BY THE IRB OR THE PRIVACY BOARD SO ALL OF THE BELLS AND WHISTLES, THE CRITERIA, THE REQUIREMENTS FOR USE OF THE HIPAA EXEMPTION HAVE BEEN SATISFIED. THAT'S THE--THAT'S THE HYPOTHETICAL, BUT THE PHI HERE ARE LESS PRISTINE THAN 1 MIGHT LIKE BECAUSE THEY CONTAIN A LOT OF DIFFERENT KINDS OF DATA THAT ARE BURIED WITHIN THE PHI. THIS BY THE WAY, I HAVE TO SAY, WHAT I'M ABOUT TO SHOW HERE I'M SHOWING FOR THE PURPOSE OF UNDERSTANDING THE HIPAA EXEMPTION BUT THIS IS A PROBLEM WE HAVE IN RESEARCH ALL THE TIME WHICH IS THAT INVESTIGATORS, THEY WANT A WAIVER OF AUTHORIZATION OR THEY WANT OR GET AN AUTHORIZATION AND THEY FAIL IN THE AUTHORIZATION TO LIST HIV INFECTION, SEXUALLY TRANSMITTED DISEASES, MENTAL HEALTH OR HYGIENE OR DIAGNOSIS INFORMATION, THEY FAIL TO LIST THAT SO WHEN A HOSPITAL HANDS OVER THOSE DATA WITHOUT THE SPECIFIC REFERENCES IN THE CONSENT/AUTHORIZATION FORM THAT, IS A PROBLEM. IT'S A LEGAL, IT'S A GENERAL LEGAL PROBLEM DEPENDING ON THE STATE LAWS THAT APPLY. STEPHEN DID YOU WANT TO SAY SOMETHING? >> I WANTED TO ASK AND MAYBE WE CAN SAVE THE ANSWER TO THE END BUT THIS IS EXCLUSIVELY FOR SECONDARY USE, NOT FOR THE COLLECTION OF THE DATA? >> EXACTLY. >> SO I'M JUST ANTICIPATING THE EXAMPLES YOU'RE GOING TO GIVE, I JUST THINK ABOUT WHEN THOSE WOULD APPLY ADDITIONALLY IN THE SECONDARY UNITS WHEN THEY HAVEN'T ALREADY BEEN DISCHARGED IN THE PRIMARY. >> YEAH. >> PRIMARY COLLECTION. >> OKAY, LET ME GO THROUGH AND THEN WE WILL CONDITIONAL BACK TO THAT QUESTION. OKAY? SO HERE ARE CATEGORIES. SO THIS INVESTIGATOR THINKS HE OR SHE IS SCOTT FREE BECAUSE THEY HAVE THE FABULOUS EXEMPTION AND THEY HAVE THE PAIEVER OF AUTHRADIO RISATION OR PRIVACY BOARD. THEY'RE SET TO GO. THEY THEN DIG INTO THE DATA, HERE AND WHAT THEY FIND IN THE DATA IS THEY FIND HIV/AIDS INFORMATION, THEY FIND GENERATEDET INFORMATION, THEY FIND MENTAL HEALTH INFORMATION, THEY FIND DEVELOPMENTAL INFORMATION, THEY FIND TUBERCULOSIS INFORMATION, EERCH OF THESE AND PROTECTED BY DIFFERENT LAWS IN DIFFERENT STATES. MOST STATES, A MAJORITY OF THE STATES HAVE CONFIDENTIALITY LAWS THAT PERTAIN TO MOST OF THESE. EVERY STATE HAS A HIV LAW, EVERY STATE I KNOW OF HAS A MENTAL HEALTH LAW, 20 OR 25 STATES HAVE HEALTH LAWS REGARDING GENETIC INFORMATION. ALL WE'RE SAYING IN THE RECOMMENDATION, WE'RE NOT SAYING THE INVESTIGATOR CAN'T DO THE RESEARCH AND TAKE ADVANTAGE OF THE EXEMPTION BUT JUST SAY WHG YOU DO THE RESEARCH, YOU NEED TO TAKE ACCOUNT OF ALL THE OTHER KINDS OF LAWS THAT MIGHT APPLY EVEN TO YOUR INTERNAL USES OF THOSE IDENTIFIABLE DATA FOR RESEARCH PURPOSES AND BY THE WAY, I SHOULD HAVE ADDED HERE THE FEDERAL LAW WHICH IS PRIMARY WHICH IS THE CONFIDENTIALITY WHICH IS SUBSTANCE ABUSE AND CHEELISM TREATMENT RECORDS AND DIAGNOSIS. SO THE ONLY THICK THIS RECOMMENDATION IS SAYING, IS YOU CAN'T DO THE RESEARCH, IT'S JUST SAYING THAT HIPAA EXEMPTION DOES NOT EXEMPT RESEARCH, FROM OTHER SETS OF FEDSERAL OR STATE LAWS OR REGULATIONS THAT MIGHT AMRI TO THE INTERNAL USES OF THE DATA AND WE'RE ADVICING THAT THE INVESTIGATOR BEFORE HE OR SHE TAKES ADVANTAGE OF THE EXEMPTION OR THEIR EN--STRATEGIES TUITION WHICH IS CHARGED ULTIMATE GOAL PAY LIE WITH RESPONSIBILITY FOR OBEYING THESE LAWS IN REGARD TO THEIR USE, INTERNAL USE OF MEDICAL RECORDS WOULD NEED TO TAKE ACCOUNT OF THAT. YOU NEED TO TAKE MORE ACCOUNT OF IT IN COLLABORATIVE RESEARCH IN WHICH THERE'S A WAIVER OF AUTHORIZATION TO DISCLOSE THE INFORMATION BECAUSE MANY OF THE STATE LAWS ARE TIED TO DISCLOSURE RATHER THAN USE AND THEY WOULD CERTAINLY APPLY TO DISCLOSURE EVEN IF YOU HAVE A WAIVER OF AUTHORIZATION TO DISCLOSE, THERE STILL MAY BE A STATE BAR TO THAT BASED OFFICE OF DIVERSITY THESE OTHER LAWS AND THE FEDERAL BAR OF COURSE WITH THE CONFIDENTIALITY OF SUBSTANCE ABUSE AND ALCOHOLISM TREATMENT. SO THAT IS THE RECOMMENDATION, IT'S HIGHLIGHTING THE FACT THAT 1--THE HIPAA EXEMPTION GETS YOU OUT OF THE COMMON RULE, BUT IT DOESN'T GET YOU OUT OF ALL OF THESE OTHER STATE AND FEDERAL LAWS. >> MARK, I TAKE BACK MY QUESTION BECAUSE I WAS THINKING ABOUT REPORTING REQUIREMENTS, NOT CONFIDENTIALITY. >> OKAY. YEAH. SO THOSE ARE THE RECOMMENDATIONS. THERE IS A LONGER DOCUMENT WHICH TALKS ABOUT EACH OF THESE IN DETAIL. I DON'T THINK THAT--I SHOULD SAY--I THINK THAT ALL I SAID TODAY IS CONSISTENT WITH THE CONTENT OF THE WRITTEN DOCUMENT. WHAT I WOULD SUGGEST IS THAT ON THE SECOND POINT WHICH WE DIGS CUSS INDEED REGARD TO THE BUSINESS ASSOCIATE, I'LL GO BACK TONIGHT AND TRACK CHANGES AND WILL TRY TO CHANGE LANGUAGE IN THAT RECOMMENDATION. YEAR NOT ASKING YOU TO APPROVE THE POWER POINT. WE'RE TALKING ABOUT WHAT WE'RE OFFERING FOR APPROVAL WILL ULTIMATELY BE TOMORROW, THE TEXT OF THE RECOMMENDATION. SO I WILL GO BACK AND TRY TO MAKE CHANGES IN REGARD TO THE HIPAA DISCUSSION. , SO, THANK YOU MARK AND I THINK THAT SHOULD BE OUR GOAL AND I WOULD ENCOURAGE EVERYBODY TO TAKE A LOOK AT THAT TONIGHT, WITH THE UNDERSTANDING THAT THAT SECTION, QUESTION 2 IS GOING TO BE REVISED BUT THE REST OF IT WE SHOULD BE PREPARED TO DISCUSS TOMORROW. GIVEN THAT'S WHERE WE STAND AND GIVEN THAT THE 7-POINTS I THINK WERE POINTS DISCOVERED OR RAISED BY THE SUBCOMMITTEE, NOT EXPLICITLY ASKED OF US, I WILL GIVE THE COMMUNITY 1 LAST CHANSZ TO ASK IF THERE'S SOMETHING THAT THE SUBCOMMITTEE MISSED THAT WE FEEL SHOULD BE AN IMPORTANT CONSIDERATION. GOING, GOING? OKAY. SO GOOD. SO WE'LL COME BACK TOMORROW--OH DIANEA. >> SURE. >> MARK, ON THESE INFORM CONSENT DOCUMENTS THAT ARE ACADEMIC INDUSTRY COLLABORATIONS WHERE I'M NOW MORE FREQUENTLY SEEING THAT YOUR INFORMATION IS GOING TO A COMPANY THAT'S NOT COVERED BY HIP AND THEREFORE SO ASSURANCE IS MADE THAT YOUR PRIVACY WILL BE PROTECTED SO WHERE DOES THAT FALL IN THIS DISCUSSION? >> WELL, THAT'S REALLY A--THAT'S AN IMPORTANT HIPAA QUESTION BUT IT'S NOT REALLY--DOESN'T REALLY INTERSECT WITH THIS BECAUSE THE HIPAA EXEMPTION IS ONLY AVAILABLE TO ENTITIES THAT ARE USING THEIR OWN IDENTIFIABLE INFORMATION OR OTHER IDENTIFIABLE INFORMATION COVERED BIENTITIES AND PHARMA COMPANIES IN GENERAL UNLESS THEY HAVE SOME KIND OF CASE MANAGEMENT FUNCTION WHICH WOULD MAKE A PIECE OF THEM PERHAPS A COVEREDDENTITY AND THEY WOULD BECOME A HYBRIDDENTITY EXCEPT FOR THAT RARE EXCEPTION, PHARMA COMPANIES, BIOTECH, DEVICE ARE NOT COVERED ENTITIES. >> I UNDERSTAND THAT BUT THEY TEAM WITH COVERED ENTITIES. >> THEY DO BUT THIS EXEMPTION WOULD NOT ALLOW THE DISCLOSURE OF PHI OUTSIDE OF THE HIPAA COVERED ENTITIES FOR THESE RESEARCH PURPOSES SO IT WOULD NOT ALLOW, SO YOU COULD NOT AS A PHARMA COMPANY COME IN AND EXPECT THAT YOU WOULD BE ABLE UNDER THIS EXEMPTION TO GET INFORMATION, TO GET IDENTIFIABLE INFORMATION THAT WOULD BE USED FOR RESEARCH. >> SO I THINK YOU KNOW ANOTHER WAY TO ARTICULATE THAT BECAUSE THE EXEMPTION, IT'S NOT SO MUCH WHAT THE EXEMPTION ALLOWS TO YOU DO, IT'S THAT THAT RESEARCH WHILE YOU CAN DO IT WOULDN'T FALL UNDER THE EXEMPTION. YOU WOULDN'T BE ABLE TO EXEMPT IT. YOU HAVE TO GET EITHER AUTHORIZATION OR--YOU WOULD HAVE TO GET WAIVER OF CONSENT AND AUTHORIZATION WITH A FULL IRB PROTOCOL OR YOU GET CONSENT AND AUTHORIZATION WITH A FULL IRB PROTOCOL. SO THIS WOULD NOT FACILITATE THAT CATEGORY OF RESEARCH. >> OKAY. GREAT. >> THANK YOU MARK. >> THANK YOU. >> SO MICHELLE? SO WE'RE ACTUALLY EARLY, BUT I'M--I'M VERY--VERY EARLY, BUT I'M SENSITIVE TO YOU KNOW THESE ISSUES, IT'S VERY HARD TO PREDICT HOW COMPLEX THESE ISSUES ARE GOING TO BE OR WHAT ISSUES ARE GOING TO COME UP AND I WOULD LIKE TO KEEP MOVING AND IT'S A LITTLE BIT EARLY FOR LUNCH. BUT ONLY MICHELLE IF YOU'RE READY? >> [INDISCERNIBLE] >> OKAY, THANK YOU. SO THE NEXT TOPIC IS CONTEXT IN SINGLE IRB REVIEW. MICHELLE RUSSELL-EINHORN. SWITCHING SUBCOMMITTEES. >> GOOD MORNING, THANKS. SO I DO NOT HAVE ANIMATED GRAPHICS LIKE MARK BARNES, HE'S A REALLY HARD ACT TO FOLLOW O I'LL ASK YOU TO HAVE A LITTL SYMPATHY FOR ME. BUT I HAVE TO SAY, I DO WANT TO JUST THANKULAR, ASKED TO JUST TO RECAP TO THINK ABOUT POSSIBLE EXCEPTIONS TO REQUIREMENTS FOR SINGLE IRB REVIEW FR MULTISITE RESEARCH. WE TALKED ABOUT IT AT A PREVIOUS MEETING. THE PREVIOUS MEETING ACTUALLY FOCUSED IN PART ON THE EXCEPTIONS THAT WE HAD ENCLUEDED IN THE SACHRP, COMMENTS TO NOTICE OF PROPOSED RULE MAKING, I TOOK THE COMMENTS THAT CAME FROM THIS GROUP AND WE HAD A--WE HAD A MEETING OF THE SUBCOMMITTEES TO DISCUSS IT. IN FURTHER DETAIL. WE ALSO HAD A PRESENTATION FROM V. A. TO PROVIDE US WITH SOME INFORMATION ON V. A.'S EXPERIENCE WITH SINGLE IRB REVIEW AND MULTISITE RESEARCH AND SO, THIS IS--THIS IS A WRITTEN DOCUMENT BECAUSE WHAT WE WENT OVER THE LAST TIME I WAS HERE AT THE PODIUM ON THIS TOPIC WAS A POWER POINT. SO THIS IS--AGAIN RECOMMENDATIONS FOR EXCEPTIONS TO REQUIREMENTS FOR SINGLE IRB REVIEW OF RESEARCH AND STEPHEN UNLESS YOU HAVE ANY OBJECTION I'M GOING TO DO MY USUAL, LET ME GIVE YOU AN OVERVIEW OF THE DOCUMENT AND THEN WE CAN GO BACK TO THE BEGINNING. OKAY? >> [INDISCERNIBLE] >> WELL ACTUALLY IT SHOULD BE IN SMALLER FONT, BUT I DON'T KNOW HOW TO DO THAT SO IF ANYONE WOULD LIKE TO COME UP HERE AND SHOW ME HOW TO DO THIS, I AM WILLING TO ACCEPT THE ASSISTANCE. [LAUGHTER] I FLUNKED TECHNOLOGY. SEE, HEY, THANK YOU. CAN YOU MAKE IT JUST SLIGHTLY LARGER. THERE YOU GO. PERFECT! [LAUGHTER] OKAY. ALL RIGHT. SO IF YOU WILL BEAR WITH ME, WHAT I WOULD LIKE TO DO IS GIVE YOU A GENERAL SNAPSHOT, A GENERAL OVERVIEW, I SHOULD SAY, OF THIS DOCUMENT, AND THEN WE'LL GO BACK AND PARSE THROUGH IT. SO THE INTRODUCTION BASICALLY DISCUSSING THE RECENT INITIATIVES SO IT SUMMARIZES VERY BRIEFLY THAT NIH ISSUED A POLICY AND THAT THE NPRM INCLUDED A PROVISION INCLUDING SINGLE IRB REVIEW FOR MULTISITE RESEARCH, AND THAT'S INCLUDED IN THE FINAL REVISED RULE. THE SECOND SECTION IS IT RESTATES WHAT THE EXCEPTIONS ARE TODAY IN THE NIH POLICY, THERE'S AN EXCEPTION THAT TALKS ABOUT WHERE THE PROPOSED SIRB WHERE IT'S PROPOSED BY TRIBAL FEDERAL STATE LAW OR A COMPELLING JUSTIFICATION FOR THE EXCEPTION. >> THE SIMILAR PART IS ACCEPTED BY THE NRIERKS H RULE OF LAW, IT'S WORDED SLIGHTLY DIFFERENTLY BUT INSTEAD OF TALKING ABOUT COMPELLING JUSTIFICATION, IT TALKS ABOUT FEDERAL DEPARTMENT OR AGENCY DETERMINE THAGOREAN THE SINGLE IRB REVIEW IS NOT APPROPRIATE FOR THE PARTICULAR CONTEXT. AND SO, THAT'S WHERE CHANGE WORDING FROM THE WORD STUDY IN THE NPRM TO THE WORD CONTEXT IN THE FINAL RULE. OHRP REQUESTED THAT WE CONSIDER THE CRITERIA, THAT DEPARTMENTS AND AGENCIES MIGHT CONSIDER WHEN DETERMINING THAT SINGLE IRB REVIEW IS NOT APPROPRIATE FOR PARTICULAR CONTEXT. SO, HERE IS THE DISCUSSION PART, SO IT REPEATS, PREVIOUSLY SACHRP, DISCUSSED POSSIBLE EXCEPTIONS FOR SINGLE IRB REVIEW IN MULTISITE RESEARCH IN THE COMMENTS TO THE NOTICE OF PROPOSED RULE MAKING AND WE'LL GO OVER THAT IN A LITTLE MORE DETAIL. THAT WE--WELL, ACTUALLY LET ME GO BACK TO 1. SO ULTIMATELY, THIS WAS FROM THE COMMENTS. ULTIMATE GOAL--ULTIMATELY, 2 OF THE BULLETS WERE INCORPORATED SO WHERE LOCAL IRB REVIEW IS REQUIRED BY FEDERAL TRIAL, FEDERAL STATE LAWS, AND WHERE IT'S NOT APPROPRIATE AND AND THEN, LET'S SEE, SORRY. HAVING EYE GLASS TROUBLE HERE, NEED TO TAKE THEM OFF. SO WHERE LOCAL IRB REVIEW IS REQUIRED BY FEDERAL STATE OR OTHER REGULATIONS, WHERE THE FUNDING AGENCY DETERMINES IS NOT APPROPRIATE, WE NOTE THAT IF RESEARCH IS NOT FEDERALLY FUNDED IT WOULD NOT BE SUBJECT TO THE REQUIREMENTS AND AFTER RESILIENCE VIEW THERE'S NO REASON TO EXEMPT RESEARCH THAT DOES NOT MEET THE DEFINITION OF CLINICAL TRIAL. SO THAT ACTUALLY CAME FROM A CONVERSATION AT THE LAST MEETING, WHERE IT SEEMED LIKE WE DIDN'T SEEM TO COME UP WITH A REASON WHY THAT SHOULD MAKE A DIFFERENCE? WITH RESPECT TO THE EXCEPTION IN TERMS OF A NUMBER OF SITES WE HAD INPUT FROM THE VA THAT WAS USEFUL AND THERE WAS A SENSE THAT IF IT FTION UNDER 5 SITES THAT YOU COULD HAVE A SHORTER TIME FRAME AND IF IT WAS OVER 5 SITES, THAT YOU HAD LONGER TIME FRAMES AND SO IT WAS WORTH HAVING THE SINGLE IRB REVIEW FOR MULTISITE TRIALS. SO, THIS IS WHERE WE GET INTO THE DIFFERENCE BETWEEN THE WORD STUDY AND THE WORD CONTEXT AND HERE WE WROTE THAT SACHRP, USES THE WORD STUDY OR CONTEXT OR THE CIRCUMSTANCES THAT FORM THE SETTING IF ARE AN EVENT, STATEMENT OR IDEA IN TERMS OF WHICH IT CAN BE FULLY UNDERSTOOD AND ASSESSED. SO ULTIMATELY, WE BROUGHT THIS BLACK TO THE SUBCOMMITTEES, AND REALLY BASED UPON THE CONVERSATION WITHIN THE COMMUNITIES THERE WERE 3 EXEMPTIONS THAT WE FELT DESERVED FURTHER DISCUSSION. ONE IS WHETHER RESEARCH INVOLVES 5 OR FEWER SITES WITH THE FEELING BEING THAT THIS SHOULD BE ELIGIBLE FOR AND EXEMPTION FOR SINGLE IRB REVIEW, WHERE REVIEW BY A SINGLE IRB IS UNABLE TO MEET THE NEEDS OF THE SPECIFIC POPULATION SO THIS TIES INTO THIS ISSUE OF IF YOU HAVE VULNERABLE POPULATIONS DOES THAT MAKE IT PER SE INAPPROPRIATE TO HAVE SINGLE IRB REVIEW IN MULTISITE RESEARCH AND I THINK THE CONSENSUS WAS, NO, JUST BECAUSE THERE'S VULNERABLE SUBJECTS DOESN'T MEAN IT'S NOT, YOU KNOW A POSSIBLE SCENARIO, BUT REALLY WE NEEDED TO BE MORE SPECIFIC ABOUT WHAT TYPES OF SITUATIONS INVOLVING VULNERABLE POPULATIONS MIGHT BE APPROPRIATE FOR AN EXEMPTION. AND THE SECOND 1 WAS AN ISSUE THAT ACTUALLY CAME UP AT THE LAST SUBCOMMITTEE MEETING, IT WAS NOT DISCUSSED AT THE LAST TIME AT SACHRP, AND THAT WAS WHETHER RESEARCH INVOLVES POLITICAL CONTROVERSIAL OR SENSITIVE ISSUES SUCH THAT REVIEW BY LOCAL IRBs WOULD BETTER ADDRESS THESE CONCERNS. SO, THIS PARAGRAPH TALKS ABOUT THE 5 OR FEWER SITES THAT THERE WAS, THAT WE AT LEAST IN THE SUBCOMMITTEES, WE IN THE DOCUMENT BRING HERE TO SACHRP, SO WE CHANGE THE WORDING WHETHER VULNERABLE POPULATIONS CONSITUTE ACE VALID REASON AND THE CONSENSUS IN THE SUBCOMMITTEE SYSTEM THAT SINGLE IRB REVIEW IS NOT PER SE INAPPROPRIATE BUT THERE WERE SITUATIONS THAT WIERKS IDENTIFIED WHERE AN IRB, A SINGLE IRB MIGHT NOT BE THE BEST IRB TO ADDRESS THE NEEDS OF SPECIFIC POPULATIONS AND THERE'S 3 EXAMPLES THAT WE PROVIDE HERE WHICH WE CAN GO BACK OVER. AND THEN THE THIRD 1 THAT WE'RE RECOMMENDING IS TO ACCEPT RESEARCH THAT HAS POLITICAL CONTROVERSIAL OR OVERTONES THAT A BETTER IRB WOULD ADDRESS THOSE CONCERNS. SO THE EXAMPLE WE DISCUSS WAS RESEARCH INVOLVING MEDICAL MARIJUANA AND THE THOUGHT THIS WOULD BETTER BE REVIEWED EYE AN IRB, AS OPPOSE IT AN IRB THAT DOES NOT HAVE EXPERIENCE AND BRING IN AN AD HOC CONSULTANT. YOU CAN BRING THAT IN, THAT'S PERMITTED UNDER REGULATIONS, THE THOUGHT WAS IF YOU REALLY WANT TO PROTECT PEOPLE AND RESEARCH AND YOU REALLY WANT TO HAVE THE RIGHT EXPERTISE AND YOU'RE DEALING WITH AN ISSUE THAT IS OF SOME SENSITIVITY THEN THAT MIGHT WELL BE A SITUATION WHERE YOU SHOULD NOT HAVE 1 IRB FOR MULTISITE RESEARCH. AND THEN IN CONCLUSION THAT SACHRP, DOES SUPPORT THE GOALS SINGLE IERKTS RB REVIEW IN IMPROVING RESEARCH SUBJECTS BUT SUBMITS SITUATION WHERE IS THE SCENARIO MIGHT NOT BE THE MOST IMPORTANT AND RECOMMENDS 3 EXCEPTIONS. SO, I'M HERE TODAY TO OFFER THIS DOCUMENT TO THE GROUP FOR DISCUSSION SO STEPHEN DO HAVE YOU ANY IMMEDIATE COMMENTS? >> WELL I DO. SO THE FIRST IS A FRAMING IS A FRAMING POINT. WE WERE ASKED TO IDENTIFY THE CONSIDERATIONS THAT AGENCIES SHOULD USE IN TRYING TO DESICIDE WHETHER SINGLE IRB IS APPROPRIATE AND I THINK THAT'S WHAT WE SHOULD STICK TO, THAT'S THE LANGUAGE AND FRAMING WE SHOULD USE THROUGHOUT THE DOCUMENT AS OPPOSING, AS OPPOSE TO RECOMMENDING SPECIFIC EXCEPTIONS. SO, THE LANGUAGE AROUND THE 5 IRB, THE 5 SITE LIMIT, I THINK WE SHOULD JUST SAY THAT'S SOMETHING THAT SHOULD BE TAKEN INTO CONSIDERATION, NOT THAT WE FEEL THAT THAT SHOULD BE AN EXCEPTION BECAUSE I THINK IT'S VERY STUDY SPECIFIC. SIMILARLY, I THINK WITH THE MULTIPLE, WITH THE--WITH THE VULNERABLE POPULATION EXAMPLES WE GIVE, THERE'S OBVIOUSLY ANOTHER POINT AT WHICH THAT CAN BE ADDRESSED WHICH IS IN THE CHOICE OF THE SINGLE IRB. AND WE DON'T MAKE THAT EXPLICIT BUT TO ME IN MANY CASES IT WOULD BE BETTER TO FIND AN IRB THAT WAS QUALIFIED TO DO BOTH PEDIATRIC AND MATERNAL REVIEW RATHER THAN SPLITTING IT OUT BECAUSE THAT'S WHAT THE INSTITUTION DID. SO, I THINK ALL OF OUR--ALL THE POINTS ARE GREAT AND THEY'RE ALL THINGS TO CONSIDER AND I JUST--MY MAIN CONCERN IS THAT THEY BE FRAMED AS POINTS TO CONSIDER, NOT AS RECOMMENDATIONS OR EXCEPTIONS. OTHER COMMENTS? >> THIS IS KAREN FROM V. A. FIRST OF ALL, THANK YOU FOR THE DOBLG UMENT. THESE ARE HARD TO DO AND DIFFICULT TO ATTACK BECAUSE THAT'S WHAT WE'RE DOING HERE. WHAT I'M CONCERNED ABOUT IN SPEAKING FROM V. A. IS THAT IT APPEARS THAT V. A. IS MAKING YOUR--YOU'RE ACCEPTING V. A.'S EXPERIENCES AS THE RECOMMENDATIONS FOR SACHRP, SO I'M WORRIED FROM THAT, FROM A FEDERAL GOVERNMENT PERSPECTIVE BECAUSE YOU KNOW IT'S--WHAT ABOUT NIH, WHAT ABOUT D.O.D. AND WHAT HAVE BEEN THEIR EXPERIENCES WITH MULTISITE REVIEW? SO WHILE WE DO IN V. A. HAVE AN INCREDIBLE AMOUNT OF EXPERIENCE, OUR DATA IS CONTINUALLY CHANGING. SO WHAT I'M READING ABOUT, AND LOOKING AT THIS IN A HIGHLY POLITICAL ENVIRONMENT IS THAT, OH, WELL, IT'S GOING TO COME BACK TO V. A. WELL GIVE US ALL YOUR DATA ON 5 OR HOW DID YOU COME TO 5? WE'RE CONTINUALLY CHANGING SO I WILL MAKE A RECOMMENDATION THAT WE AVOID NAMING A FEDERAL AGENCY BECAUSE THAT REPRESENTS OUR EXPERIENCE. IT MAY NOT BE REFLECTIVE OF OUR OTHER SISTER AGENCIES. >> THANK YOU. AND THANK YOU FOR GETTING ON THE CALL AND TALKING TO US ABOUT THIS. IT REALLY WAS VERY, VERY HELPFUL AND I THINK HAD YOU CHOSEN YOUR ANALYSIS AT DIFFERENT THAN 5, IT MIGHT TURNED OUT TO BE A NUMBER DIFFERENT THAN 5 AND I THINK THAT'S A GOOD CAUTION AND I THINK WE CAN PROBABLY TAKE OUT SPECIFIC ATRIBUTIONS TO THE V. A. >> WE WERE SOMEWHAT SENSITIVE TO THAT AS WELL. ON THE OTHER HAND IN PRESENTING THE TOPIC, IT SEEMED WE NEEDED SOME DATA TO BACK IT UP. >> WELL THEN I WILL ASK, WHY DIDN'T YOU SEEK THE OTHERS? BECAUSE IT'S NOT JUST V. A. SO WE HAVE NRIERKS--NIHH IT'S LIKE IT'S SKEWED. SO IT NEEDS TO BE FAIR AND BRALLANCED SO THAT'S MY CONCERN WHEN V. A. IS SINGLED OUT IN A GUIDANCE DOCUMENT FROM OUR EXPERIENCE BECAUSE WE HAVE THE NIH EXAMPLE THAT HAS A LOT OF EXPERIENCE WITH THEIR DIFFERENT CENTRALIZE IRBEXPZ THEN OTHER SITES THAT USE MULTISITE IRBNO, SIR THE FEDERAL GOVERNMENT SO THAT'S MY CONCERN WITH SINGLING OUT V. A. I DON'T THINK IT'S SOMETHING THAT V. A. WOULD--IT'S SACHRP'S GUIDANCE BUT I'M WORRIED ABOUT ISSUES THAT ARE IN THE STATEMENTS. >> WELL YOU MAKE A GOOD POINT THAT IT'S V. A.'S EXPERIENCE AND THERE ARE OTHER FEDERAL AGENCIES THAT HAVE EXACTLY THE SAME TYPE OF EXPERIENCE SO I AGROW AND WE CAN WORK ON REFRAMING THAT. >> SO LET ME ASK, VALERIE, WHETHER--[LAUGHTER] --WHETHER THERE ARE OTHER FEDERAL GOVERNMENT AGENCIES PRESENT TODAY WHO WOULD BE PREPARED OR WILLING TO SHARE ANY EXPERIENCE THEY MAY HAVE WITH SINGLE IRB REVIEW? >> SORY. I KNOW THE NCI SORT OF HAS A GREAT DEAL OF DATA AND THEY DO PRESENT ON IT FAIRLY REGULARLY, BUT I HAVEN'T ASKED ANYBODY IN PARTICULAR. AND I CAN GO BACK AND ASK. >> AND SOME OF THAT'S BEEN PUBLISHED. >> A GREAT DEAL OF IT, YES. >> YEAH. >> MY RECOLLECTION OF THE PUBLIC STUFF I'VE SEEN IS GENERALLY SORT OF A CROSS BENEFIT KIND OF THING AND IT'S GENERALLY COMES OUT, GENERALLY IN FAVOR OF THE SINGLE IRB MODEL. I DON'T THINK THEY BREAK DOWN--I DON'T THINK ANY OF THAT LITERATURE ADDRESSES SPECIFIC CRITERIA, IN WHICH IT MIGHT OR MIGHT NOT WORK IS MORE OF AN ASSESSMENT. >> I BELIEVE THAT'S CORRECT. YES. >> SO STEPHEN CAN I GETD BACK TO YOUR 2 COMMENTS? ONE IS THAT YOUR RECOMMENDATION IS TO REFAME IT AS POINTS TO CONSIDER AS OPPOSE TO RECOMMENDED EXCEPTIONS. I MEAN I PERSONALLY THINK THAT'S FINE IF THAT'S THE GROUP CONSENSUS. THE SECOND 1 THOUGH WAS WHERE YOU TALKED ABOUT THE PROPOSAL INSTEAD OF TALKING ABOUT VULNERABLE POPULATIONS BUT THE NEEDS OF SPECIFIC POPULATIONS, THAT ACTUALLY AT THE TIME THAT THE CHOICE OF THE SINGLE IRB IS CONSIDERED THAT THEY SHOULD CONSIDER 1 THAT HAS EXPERTISE IN BOTH AREAS WHERE ARE YOU GOING WITH THAT IN TERMS OF CHANGING THAT POINT TO CONSIDER? >> WELL I THINK, SO THE POINT TO CONSIDER I THINK IS VALID. OBVIOUSLY, THAT IS SOMETHING, THE NEEDS OF THE SPECIFIC POPULATIONS AND PARTICULARLY POPULATIONS THAT ARE SEPARATED BY RESEARCH SITE MIGHT BE A VALID CONSIDERATION. I JUST--YOU KNOW, AND THIS MAY BE MY OWN--THIS IS MY OWN OPINION, OTHERS MAY NOT AGREE, OBVIOUSLY, I COME FROM A SINGLE SINGLE IRB WORLD, SO THAT'S MY BACK GRUND AND I KNOW THERE'S A LOT OF FLEXIBILITY FOR MANAGING THIS KIND OF THING AND I DON'T WANT TO--I THINK TO MAKE A STRONG RECOMMENDATION WITH THESE EXAMPLES, KIND OF INVITES A LOT OF EXCEPTIONS BASED ON CIRCUMSTANCES THAT FROM A SUBJECT PROTECTIONS POINT OF VIEW, I THINK ARE BETTER ADDRESSED BY HAVING AN APPROPRIATE SINGLE IRB. SO THERE IS THE DOWN SIDE ALWAYS, IT'S NOT JUST TIME OF HAVING MULTIPLE IRB REVIEWS WITH MULTIPLE VERSIONS OF THE CONSENT FORM AND MULTIPLE CHANGES REQUESTED FROM THE PROTOCOL WHICH MIGHT GO BEYOND THIS WHOLE IDEA OF THIS IS BECAUSE THERE'S ALMOST SORT OF AN ARBITRARY SENSE OF THOSE THINGS. THE 1S THAT ARE SPECIFIC TO THE POPULATIONS ARE OBVIOUSLY APPROPRIATELY WANT TO CAPTURE. SO IN JUST READING THE EXAMPLES, I THINK IT MAKES SENSE ON ITS FACE. READING THE EXAMPLES, MY REACTION WAS, WELL, I THINK THIS IS BETTER ADDRESSED THROUGH THE PROPER CHOICES OF THE IRB. IESM NOT SURE, I WOULD LOVE TO HAVE HOW OTHER PEOPLE THINK ABOUT THAT BECAUSE OBVIOUSLY I HAVE A PARTICULAR PERSPECTIVE THAT I SHARE. >> I A SIMILAR REACTION TO THEM AND IN THE COURSE OF THE DISCUSSION, RIGHT? WITH THE SUBCOMMITTEE, SO MY WORRY IS THAT THESE ARE THE SORTS OF THINGS THAT IF WE RECOMMENDED THEM AS TRUE EXCEPTIONS, AS OPPOSE TO POINTS TO CONSIDER, THEN THE EXCEPTION WILL FOLLOW THE RULE AND THAT WE WILL END UP NOT REALLY UTILIZING SINGLE IRBs AS MUCH AS THE COMMON RULE REVISIONSER SUGGESTING THEY OUGHT TO BE USED. YOU KNOW BECAUSE EVERYTHING COULD REALLY--DEPENDING ON WHAT THE INVESTIGATOR IS SAYING OR WHAT THE SITE THINGS, EVERYBODY COULD BEING DESCRIBED AS I SPECIFIC POPULATION SO YOU COULD BE LIKE SPLIT HAIRS ABOUT THAT AND SIMILARLY, YOU KNOW WHAT COUNTS AS A SENSITIVE TOPIC. I THINK STEPHEN'S POINT IS WELL TAKEN. YES, THERE ARE SENSITIVE TOPICS BUT THEN YOU IDENTIFY THE SINGLE IRB THAT CAN ADDRESS THEM AND DOESN'T NECESSARILY MEAN THAT EACH LOCAL IRB NEEDS TO ADDRESS THOSE SENSITIVE TOPICS ESPECIALLY BECAUSE THEY MIGHT REACH CONFLICTING CONCLUSIONS THAT WOULD ELIMINATE SOME OF THE EFFICIENCIES AND CONSIDERATIONS THAT WERE DRIVING SINGLE IRBs BUT I SECOND THE GOAL OF GETTING MORE DATA. I MEAN, ANY NUMBER THAT WE WANT TO PUT IN HERE IS A POINT TO CONSIDER WHETHER IT'S 4 OR 10 SITES OR WHEAR IT IS IT'S GOING TO SOUND ARBITRARY UNLESS WE HAVE SOME EVIDENCE BEHIND IT? , AND JUST TO ADD EVERY IRB HAS TO HAVE APPROPRIATE EXPERTISE. SO SO SOME OF THIS IS HOW MUCH IS APPROPRIATE EXPERTISE AND YOU KNOW YOU CAN GO TO A CERTAIN LEVEL AND IT'S JUST LIKE REALLY APPROPRIATE EXPERTISE BUT IT DOESN'T MEAN THAT SOMETHING SLIGHTLY LESS THAN THAT IS NOT--NOT SUFFICIENT. >> THE EXAMPLE ABOUT THE DEEP BRAIN STIMULATOR IT WAS LIKE, WELL, CAPACITY HAS BEEN DETERMINED, IT'S JUST THE FACT THAT 2 DIFFERENT RESEARCH INTERVENTIONS ARE HAPPENING AT 2 DIFFERENT SITES DOESN'T SEEM TO BE SUFFICIENT TO SUGGEST THAT YOU NEED DIFFERENTIAL IRB REVIEW AT EACH SITE. >> SO DO WE ACTUALLY NEED THIS GUIDANCE? I MEAN, I JUST--SO FIRST, IT'S MOVING FROM EXCEPTIONS TO POINTS TO CONSIDER. BUT YOU KNOW THE NIH GUIDANCE HAS COMPELLING JUSTIFICATION SO COMPELLING IS A PRETTY BROAD PHRASE AND A LOT CAN GO UNDER THAT AND THE FEDERAL AGENCY DECIDES IT'S NOT APPROPRIATE AND IN THE PROPOSED FINAL RULE AND SO TO ME WHAT THAT SAYS IS THAT BOSTON CHILDREN'S HOSPITAL COULD SUBMIT A GRANT AND THENCH THEY COULD SAY, WE THINK THAT THERE NEEDS TO BE, YOU KNOW A VERY SPECIALIZEDNYONATAL IRB AND A SPECIALIZED PEDIATRIC IRB SO THAT WOULD BE WITHIN THE CONTEXT OF THE REQUEST AND THEN THE GOVERNMENT WOULD DECIDE WHETHER IT'S APPROPRIATE OR NOT. I GUESS, WE WERE--WE WERE ASKED TO CONSIDER THIS, WE WERE ASKED ABOUT THE DIFFERENCE BETWEEN STUDY AND CONTEXT, I DO THINK THAT CONTEXT IS A BROADER WORD THAN STUDY AND THAT PROVIDES THE PERMISSION YOU CAN SAY TO SORT OF LOOK, YOU KNOW AT MORE INFORMATION BUT I--WHAT I'M HEARING IS THAT WE DON'T HAVE ENOUGH INFORMATION OR DATA TO BE ABLE TO SAY WHETHE THERE'S A MAGIC NUMBER THAT CALLING OUT THE NEEDS OF A SPECIFIC POPULATION IS REALLY SOMETHING THAT SHOULD GO INTO CONSIDERATION OF COMPELLING JUST ISKEDZ OR NOT APPROPRIATE, AND THAT POLITICAL AND SENSITIVE AGAIN GOES BACK TO THIS ISSUE OF EVALUATING THE APPROPRIATENESS AND THE EXPERTISE OF A SPECIFIC IRB. I MEAN WE COULD STILL SAY THESE THINGS BUT I'M JUST THROWING THIS OUT. >> YEAH, THIS IS KAREN AGAIN FROM V. A. I THINK YOU TOUCHED UPON WHAT WE WERE GOING TO BRING UP HERE. THIS GUIDANCE IS DIRECTED TOWARDS US AS THE FUNDING AGENCIES, SO IT'S LIKE YOU SAID, WHEN IT COMES TO THE FUNDING AGENCY IS GOING TO DETERMINE THAT IT'S NOT AN APPROPRIATE--WHAT'S THAT CONTEXT WE WILL USE, WE WILL MAKE THAT DECISION, YOU KNOW IN CONSULTATION WITH IN FUNDING BUT IN TERMS OF WRITING GENERAL GUIDANCE FOR THIS, IT'S NONAPOPTOTIC TO THE GENERAL IRB WORLD IT'S TO THE FUNDING AGENCY, SO THE AUDIENCE IS VERY LIMITED IN THIS. SO, AND SO, I THINK THE QUESTION DOES COME, IS THIS REALLY A GOOD USE OF SACHRP'S TIME TO MAKE RECOMMENDATIONS TO US WHEN MAYBE ANOTHER TOPIC SHOULD GO FOR THE GENERAL IRB COMMUNITY? >> I THINK IT'S A GREAT DISCUSSION. YOU KNOW? AND I THINK WHAT'S REALLY FASCINATE SUGGEST HOW WE KIND OF WENT FROM A LOT OF DIFFERENT, POSSIBLE EXCEPTIONS AND THEN WE NARROWED IT DOWN AND WHEN YOU REALLY TALKED THROUGH THEM, YOU START TO REALIZE THAT MAYBE YOU DON'T NEED TO PHRASE THEM AS EXCEPTIONS, BUT I'M JUST WONDERING IF SOMETHING--LET'S ASSUME IT CAME OUT AND WE CLEANED IT UP. RIGHT? SO WHAT? >> SO I THINK ACTUALLY THAT IT HAS VALUE. AGAIN, THE FRAMING GOES BACK FROM THE REQUEST FROM OHRP, THERE ARE 2 CRITERIA, LOCAL LAW OR OTHER LAW AND THEN THERE ARE FUNDING AGENCY, DEPARTMENT OR AGENCY FEELS IT'S NOT APPROPRIATE AND THE REQUEST WAS SPECIFICALLY WHAT SHOULD--WHAT ARE SOME OF THE CONSIDERATIONS THAT THE AGENCY SHOULD TAKE INTO,A COUNT TO DETERMINE IT'S NOT APPROPRIATE. SOPHISTICATED WE WERE BT ASKED TO ADD BULLET ROM ANETS 3, 4 AND 5, WE WERE ASKED IN A GENERAL SENSE WHAT THEY SHOULD TAKE INTO CONSIDERATION. AND I THINK THE SIZE OF THE STUDY WHETHER IT BE, YOU KNOW THAT THERE MAY BE--I THINK IT'S WORTH SAYING THAT THERE MAY BE STUDIES WHERE THE SITE NUMBER IS LOW ENOUGH THAT YOU REALLY DON'T AIN ANY EFFICIENCIES OR PROTECTIONS BY HAVING SINGLE IRB REVIEW AND THAT THAT SHOULD BE TAKEN INTO CONSIDERATION. I DON'T THINK WE HAVE THE DATA TO MAKE A RECOMMENDATION ABOUT A NUMBER. ALTHOUGH WE COULD SITE AND CERTAINLY SUGGEST 5. AND I THINK, YOU KNOW THE OTHER POINTS--I DON'T KNOW WHETHER THEY NEED STATING. THEY'RE SORT OF THE OBVIOUS THINGS THAT THESE ARE THE REASONS YOU MIGHT WANT MORE THAN 1 IRB, YOU KNOW IS LOCAL CONTEXT GOES BACK TO WHAT WE'VE BEEN TALKING ABOUT ON THIS TOPIC FOR YEARS AND WHETHER YOU CAPTURE THAT AS NEEDS OF PARTICULAR POPULATIONS OR SKILLS OF PARTICULAR INVESTIGATORS, I MEAN, I THINK IT MIGHT BE WORTH ARTICULATING THOSE THINGS BUT IT IS THE DISCUSSION WE'VE BEEN HAVING AND I'M NOT SURE, OR MAYBE --I AGREE. >> IT'S AN INTERESTING CONVERSATION BECAUSE IF IN FACT THIS DOCUM WILL BE USED FOR THE FEDERAL AGENCIES AND I KIENT OF HADN'T THOUGHT ABOUT IN THAT WAY, YOU REALLY WANT TO HAVE ALL THE FEDERAL AGENCIES THAT ARE FUNDING MULTISITE RESEARCH TO REALLY HAVE INPUT INTO THIS TO SHARE THEIR CURRENT EXPERIENCES. SO, YOU KNOW WE'RE ACTUALLY LOOKING AT THIS FROM A MUCH BROADER PERSPECTIVE AND INSTITUTION AND PRIORITIES AND CONCERNS AS OPPOSE TO FUNDING AGENCIES. SO LET ME JUST ASK AND I WILL COME BACK DO YOU HAVE OR FORESEE PUTTING IN PLACE, A PROCESS--FORMAL PROCESS TO EVALUATE WHETHER A STUDY SHOULD BE EXEMPTION FROM A SINGLE IB REQUIREMENT AND WHAT HAVE YOU CONSIDERED HAVING IN THAT PROCESS IF YOU'RE ABLE TO SHARE THAT. >> WE'VE HAD A LOT OF DITS CUSHION ABOUT THE FORMAL PROCESS WE WILL HAVE IN PLACE SINCE WE COMMON RULE PROVISION OR NIH POLICY GOING TO TAKE EFFECT FOR EITHER 1 YEAR OR SEVERAL YEARS, AND SO, WE HAVEN'T FINALIZED IT BECAUSE IT DOESN'T HAVE THE URGENCY OF SOME OTHER THINGS THAT WE'RE WORKING ON. AND SO, SO WE WILL HAVE A FORMAL PROCESS BUT I CAN'T SHARE ANYTHING AT THIS TIME. >> FOR V. A. WE WILL HAVE A FORMAL PROCESS AND PUT WITH IT ENSUING GUIDANCE BUT IT'S LIKE WHAT WE SAID FOR MANY OF OUR V. A.s WE HAVE THOUSANDS OF STUDIES INVOLVING RELATIONSHIPS AND M. O. U.s FOR USE OF OUR ACADEMIC AFFILIATES SO TO BREAK THAT UP AND NOW, HAVE TO HAVE AN ARGUMENT WHO WILL USE IT, WE ALREADY HAVE THAT RELATIONSHIP. AND SO, WE WILL--WE WILL HAVE POLICIES BASED UPON THE EXISTING RELATIONSHIPS WE HAD WITH OUR TYPES OF IRBEXPZ ALSO THE TYPE OF STUDY. CERTAIN ESPECIALLY IF WHY ARE DEALING WITH POLITICAL ISSUES, SCHEDULE 1 DRUGS, SERVICE DOGS, YOU KNOW, THINGS THAT ARE RELATIVE TO OUR ORGANIZATION, SO WE WOULD INCLUDE THAT IN POLICY AND GUIDANCE. >> SO OTHER THAN PARTICIPATING IN THE DISCUSSIONS WE'VE BEEN HAVING FOR YEARS ON THIS TOPIC HERE IN 1 CONTEXT OR ANOTHER IS THE SACHRP USEFUL GUIDANCE FOR YOUR AGENCIES? >> I THINK THAT WE WILL CONSIDER THE THOUGHTS AND CONSIDERATIONS OF ANYBODY WHO WANTS TO PROVIDE THAT INFORMATION TO US. I WILL NOT SET UP THIS PROCESS SO I DON'T KNOW HOW MUCH CONSIDERATION IT WILL GIVE BUT IT WILL CERTAINLY BE CONSIDERED SO IT MIGHT BE USEFUL IT MIGHT BRING UP ISSUES THAT THE AGENCY CAN'T THINK OF OURSELVES SO WE DO ASK THE PUBLIC AND LEARNED COMMITTEES THAT ABSOLUTELY TRY. >> AND V. A. WOULD CONCUR, WE RECOGNIZE WE DO NOT HAVE ALL THE ANSWERS, SO TO GET INPUT FROM THE RESEARCH COMMUNITY AND THIS GROUP AT SACHRP, OVER WHAT WE SHOULD CONSIDER, THAT SHOULD USEFUL TO US BECAUSE IT'S USEFUL FROM YOU AS EXPERTS. >> SO SANDY FIRST. >> I'M LIBBY WHITE FROM D. O. E. AND I JUST WANT TO SAY WE CURRENTLY HAVE 2 CENTRAL IRBUSY, WE WOULD FIND ANY GUIDANCE YOU PROVIDE US TO BE VERY USEFUL. WE CURRENTLY, REQUIRE THAT YOU ANY FUNDED STUDIES FOR OUTSIDE AGENCY FUNDED STUDIES INVOLVE D. O. E. EMPLOYEES CURRENT OR FORMER EMPLOYEES, WOULD BE IRB CENTRAL. AND THEN CERTAIN TYPES OF RESEARCH LIKE [INDISCERNIBLE]. HEALTH RESEARCH FALLING UNDER A FORMER WORK OR OTHERS [INDISCERNIBLE] [LOW AUDIO ] WE ALSO REQUIRE THAT ALL RESEARCH CENTERS THAT OUR SITES DO GO TO [INDISCERNIBLE]. AND ANY RESEARCH INVOLVING MORE THAN 1 [INDISCERNIBLE] SO FOR US, TOO, RESEARCH ACTIVITIES IN THE SITES REQUIRES [INDISCERNIBLE]. BUT AT D. O. E. [INDISCERNIBLE]. >> DO YOU HAVE AN EXCEPTION PROCESS? >> WE SORT OF CONSIDERED THOSE ON A CASE BY CASE BASIS. SO GUIDANCE WOULD BE VERY HELPFUL. >> SO A LOT OF WORK I'VE DONE IS ON VULNERABLE AND SENSITIVE POPULATIONS, SO I'M WONDERING EXACTLY HOW WE WOULD FIGURE OUT IF AN IRB HAD THE EXPERTISE BECAUSE IT'S OFTEN A WEIRD NEXUS OF VULNERABILITY LAW AND PRACTICE AND A POLITICAL MOTIVATION FOR AN ISSUE AND IT WOULD BE, I THINK SOMETIMES VERY DIFFICULT FOR A CENTRAL IRB TO REALLY BE ON TOP OF THAT IN A LARGE NUMBER OF SITES ON A VERY SENSITIVE TOPIC WHERE, IT REALLY CAN BE VERY INDIVIDUAL. TOPICS LIKEABORTION, OTHER KINDS OF VULNERABLE POPULATIONS BECAUSE YOU MAY NOT WORRY ABOUT IT UNLESS YOU KNOWLEDGE--THINK THERE IS A REAL POLITICAL OR SOCIAL MOTIVATION TO REALLY GO AFTER SOMETHING THAT GIVES EXTRA UMPH TO SOME OF THE VULNERABILITIES, SO I JUST WANT TO KEEP THAT ON THE TABLE. HOW DO WE THAN A CENTRAL IRB HAS THE RELEVANT EXTRAMURAL PETTER EASE AND HOW DO THEY DO THAT WHEN SOME OF THOSE ISSUE VS A VERY LOCAL CONTEXT TO DO THAT. SOME OF THEM ARE VERY REAL. BY THE WAY, I ALSO THINK THIS WILL BE VERY IMPORTANT HAVING THE SACHRP GUIDANCE IS IMPORTANT TO INVESTIGATORS WHO NEED TO FIGURE THIS OUT AND HAVE A STARTING POINT AND ALSO TO IRBs WHO NEED TO KNOW WHEN THEY WANT TO REALLY NOT OPPOSE THIS AT ALL AND LET IT BE AND WHEN THEY REAL WANT TO JOIN WITH THEIR INVESTIGATORS IN A SENSE TO RAISE THE ISSUES. SO I THINK HAVING GUIDANCE WILL BE HELPFUL GENERALLY TO THE FIELD. >> SO JOANNE WEST WAS MOVING TOWARD HER MIC WHICH REMINDED ME THAT WE HAD A MEETING WITH PEOPLE FROM THE CDRH AND THE DEVICE PEOPLE WERE TALKING ABOUT HOW THEY DIDN'T DIDN'T THINK THAT LOCAL IRB REVIEW WAS APPROPRIATE FOR DEVICE RESEARCH. SO I E-MAILED JOANNE ABOUT THAT AND I'VE NEVER HEARD--I DON'T KNOW IF YOU HAVE ANYMORE--DID YOU GET ANY INFORMATION ABOUT THEIR CONCERNS? >> WELL LET ME START BY SAYING THAT ON BEHALF OF FDA, WE WOULD SUPPORT THE OTHER AGENCIES HERE THAT HAVE SAID THIS WOULD BE HELPFUL. WE DON'T YET HAVE IN OUR PROTOTYPE BUT AS WE INDICATED IN THE PROPOSED RULE AND FINAL RULE THAT WE INTEND TO HARMONIZE AS MUCH AS WE CAN SO WE'RE STRUGGLING WITH WITH HAD SOME OF THE SAME QUESTIONS, WHEN'S APPROPRIATE AND WHEN'S NOT APPROPRIATE SO THIS GUIDANCE WOULD BE GREAT AND I WOULD BE--IT WOULD BE A SHAME IF YOU DECIDED TO NOT GO FORWARD WITH IT. AS FAR AS DEVICE ISSUE GOES, I THINK IT'S SIMILAR TO WHAT HAVE YOU BEEN DISCUSSING THAT A LOT OF THE DEVICE STUDIES ONLY HAVE 3 OR 4 SITES AND SO, THERE ARE ASKING THE SAME QUESTIONS, DOES IT MAKE SENSE TO GO TO THE TRIEWBL OF ENTERING INTO THE WRITTEN AGREEMENTS THAT WOULD BE REQUIRED AS OPPOSE GOING TO THE 3 SITES WHEN YOU HAVE DEVICE MANUFACTURES THAT BEEN USING THE SAME SITES OVER AND OVER AND THEY HAVE THOSE ESTABLISHED RELATIONSHIPS IT'S PROBABLY QUICKER FOR THEM TO GO TO A FEW SITES THAN TO GO TO A CENTRAL IRB BUT WE DID REACH OUT TO THEM AND WE TALKED TO THEM ABOUT IT AND IT WAS SIMILAR TO WHAT YOU ALL HAVE BEEN DISCUSSING. >> SO JOANNE IT SOUNDS LIKE THOSE CONCERNS AREENTIOUS FICIENCY CONCERNS, NOT SUBJECT PROTECTION CONCERNS IS THAT FAIR? NOT WHAT I WAS EXPECTING. I WAS EXPECTING SUBJECT PROTECTION, NOT THAT EFFICIENCY CONCERNS ARE NOT IMPORTANT. >> I THINK IT'S MORE EFFICIENCY AND THE RESULTS OF THE LOCAL QUESTION AND SOME OF THE DEVICE STUDIES HAVE YOU, DEVICES QUEPED BY CLINICAL INVESTIGATOR AS OPPOSE TO A DRUG STUDY, YOU WILL NOT HAVE INVESTIGATORS DEVELOP A NEW DRUG WHERE YOU DO SEE THAT IN DEVICE WORLD A LOT AND THEY FEEL COMFORTABLE WITH THAT EN--STRATEGIES TUITION WHERE THEY ARE DOING THAT RESEARCH AND THAT IRB KNOWS THEM AND KNOWS THE RESEARCH AND SO THERE IS THAT ASPECT TO IT BUT A LOT OF IT IS ALSO THE EFFICIENCY. >> SO I HAVEN'T HEARD ANYBODY DISAGREE WITH THE DISCUSSION ABOUT THE MOVE FROM TODAY TO CONTEXT AND WHAT I'M HEARING IS CHANGE FROM RECOMMENDATIONS FOR EXCEPTIONS TO POINTS TO CONSIDER. AND THAT THE 3 THINGS THAT WE'VE IDENTIFIED, THE 3 GENERAL TOPICS, WELL, THERE'S ALWAYS SOME COME BACK ANSWER, WELL, YOU KNOW YOU MIGHT NOT NEED TO DO IT THAT WAY OR YOU COULD FIND AN IRB WITH THE RIGHT EXPERTISE THAT ULTIMATELY, ALL 3 POSE SITUATIONS WHERE, IT MIGHT BE APPROPRIATE TO NOT HAVE A SINGLE IRB AND MAYBE THAT'S ALL WE NEED TO DO TO ACCOMPLISH IS NOT TO--YOU KNOW WE KIND OF ELIMINATED THE 1S WHERE THERE'S NOT A GOOD JUSTIFICATION TO INCLUDE IT, BUT THESE 3 SEEM TO BE OKAY AS POINTS TO CONSIDER. >> SO I THINK THAT'S GOOD. I THINK--AND I APOLOGIZE IF THIS IS ALREADY IN THE DOCUMENT. >> OKAY, I LIKE YOU STEVE. >> [LAUGHTER] >> BUT I WOULD--YOU KNOW I THINK THE CONCERNS AGAIN, WE'VE BEEN HAVING THIS DEBATE FOR A DECADE, REALLY ABOUT THE ROLE OF SINGLE IRBs AND IT'S ALWAYS COME DOWN TO SUBJECT PROTECTION ISSUES AND JERRY HAD--THE ARTICLE IN THE NEW ENGLAND JOWRN WILL RAISING THE POINT THAT IT MAY BE PROTECTION OF THE SINGLE IRB AND IT'S BEEN THE DRIVER'S EFFICIENCY AND THE REACTION IS SUBJECT PROTECTIONS AND I THINK IT'S WORTH BEING EXPLICIT THAT SOME OF THE REASONS TO CONSIDER SOME OF THESE ISSUES IN CHOOSING WHETHER TO USE A SINGLE IRB OR NOT ARE IN FACT THAT A SINGLE IRB MAY NOT BE MORE EFFICIENT IN SOME OF THOSE CASES. I MEAN THAT'S THE REASON FOR THE SMALL SITE NUMBERS, THAT'S THE REASON IN THE DEVICE STUDY CONTEXT AND GIVEN THAT THAT'S THE DRIVER, I THINK IT SHOULD BE EXPLICIT IN THE RECOMMENDATION, THE REASON FOR NOT USING A SINGLE IRB IF YOU HAVE 3 SITES, IS THAT IN FACT, IT MAY TAKE AWAY FROM THEENTIOUS FICIENCY OF THE REVIEW. >> SURE. I THINK FOR THE OTHER 2 AT LEAST WITHIN THE SUBCOMMITTEES, THE CONCERN IS THAT IF YOU HAVE THE NEEDS OF SPECIFIC POPULATIONS AND IF YOU HAVE POLITICAL AND [INDISCERNIBLE] THAT DEFINE THOSE THAT GO TO IRBs WITH STRONG EXPERTISE IN PARTICULAR AREAS ARE REALLY STRONG FAMILIARITY WITH CERTAIN SENSITIVE ISSUES WITHIN A COMMUNITY THAT THAT'S--THAT'S A SUBJECT PROTECTION ISSUE AS OPPOSE TO AN EFFICIENCY ISSUE. BUT WE CAN--I THINK--I THINK WHAT I'M HEARING IS THAT, YOU THEN IS ALL GOING TO DEPEND ON EVERY STUDY. AND ALL THIS S&P JUST RAISING THESE AS GENERAL CONSIDERATIONS. BUT WITH RESPECT TO THE SITES WE CAN ACTUALLY ADD THAT. ADD MORE INFORMATION ABOUT THAT. >> IS THIS AN ALL OR NOTHING THING? IN OTHER WORDS SUPPOSE YOU HAVE 20 SITES AND A COUPLE OF THEM ARE IN PLACES WHERE THERE'S REAL SENSITIVITIES ABOUT A PARTICULAR TOPIC, DOES THAT MEAN THAT ALL 20 OF THEM HAVE TO BE OPINE ABOUT THIS? OR COULD IT BE THIS COULD BE THERE COULD BE PARSING HERE THAT MAYBE A COUPLE OF SITES NEED TO DO REVIEWS, BUT THE REST OF THEM COULD BE UNDER THE CENTRAL IRB, SO DO WE WANT TO RAISE THE QUESTION OF WHETHER THERE'S SUBTLYS POSSIBLE HERE THAT IT'S NOT ALL OR NOTHING? >> I MEAN FROM THE WORLD OF INDEPENDENT IRBs THAT'S STANDARD, THAT YOU CAN HAVE A MULTISITE TRIAL WHERE, YOU KNOW, 50 SITES RELY ON 1 IRB AND 50 SITES HAVE THEIR LOCAL IRB. >> I THINK THOUGH SINCE MUCH OF OUR AUDIENCE WILL COME FROM THE INSTITUTION-- >> BUT WE COULD RAISE IT. >> WE SHOULD MAKE THAT EXPLICIT THAT WE'RE NOT SAYING ALL OR NOTHING, THERE COULD BE SITUATIONS WHERE THERE ARE SPECIALIZED CONCERNSA THE A PARTICULAR SITE OR FOR PARTICULAR ISSUES THAT REQUIRE--AND THEREY ANOTHER THAT IRB MAY NOT BE OTHERWISE ADMINISTRATIVELY CAPABLE OF DOING A 50 SITE TEST, TO BE HONEST AND IT SHOULDN'T BE ALL OR NOTHING AND I THINK THAT SHOULD BE EXPLICIT. >> I THINK THAT'S A GREAT POINT. >> NIH FAQs MAKE THAT CLEAR. THAT WE WOULD EXPECT MOST SITES TO USE A SINGLE IRB AND THERE MAY BE SITUATIONS WHERE AN EXCEPTION IS NEEDED FOR A PARTICULAR SITE OR POPULATION AND THAT'S THE REST OF THEM WOULD BE EXPECTED TO DO. >> I GUESS I WOULD BE CONCERNED HOW WE WORDED THAT BECAUSE IT'S NOT ENTIRELY OUR PLACE TO SAY THAT IF IT'S GOING TO BE A REQUIREMENT OF A FUNDING AGENCY PERHAPS BUT WE CAN RECOMMEND AND THEN I GUESS THE QUESTION WILL COME UP WHO CAN HELP WITH MAKING THAT DETERMINATION, SO, YOU KNOW, I BEING THINK--THINK THAT'S GOING TO BE DIFFICULT FOR THE 1 INSTITUTION OUT OF 30 THAT SAYS, WELL I REALLY WANT THIS REVIEWED AT A LOCAL LEVEL AND THE AGENCY'S GOING TO SAY, THE OTHER 29 SITES, WELL, FINE WITH THE CENTRAL IRB AND I ALSO WONDER WHAT THE MOTIVE WILL BE TO SAY THAT AT THAT 1 INSTITUTION BECAUSE I'M THINKING THAT MOST OF THESE LARGE MULTIINSTITUTIONAL STUDIES ARE LESS ABOUT HIGHLY SENSITIVE CONTEXT DEPENDENT RESEARCH AND MORE ABOUT STANDARD BIOMEDICAL RESEARCH FROM A THERAPEUTIC AGENT OR SOMETHING OF THAT SORT. SO IS IT AN ISSUE OF TRUST IS IT AN ISSUE OF COST, IS IT SOMETHING THAT WE CAN'T REALLY PUT INTO THE RECOMMENDATION. >> SO I THINK MY COMMENT MAY RESPOND TO THAT I LITTLE BIT. BECAUSE WE'RE MOVING TO POINTS TO CONSIDER AND HOW TO DESCRIBE THIS, 1 THING I FELT WHEN I LOOKED AT THE EXAMPLES WAS TAKEN--THEY IT MAY NOT DRAW BROADLY ENOUGH. THEY'RE SORT OF THE CLEAR, ALMOST SET IN THE SENSE OF THE VULNERABLE POPULATIONS BUT NOT WHERE IT MIGHT BE HELPFUL TO EXPAND TO SOME POPULATIONS LIKE CERTAIN EMIGRANT GROUPS THAT MAY BE, YOU KNOW WHERE THE LOCAL CONTEXT MAY BE IMPORTANT THERE, AND MAY--WHERE A LOCAL IRB AND LOCAL--WHO HAS HAD THAT RELATIONSHIPS KNOWS WHAT THE SOME OF THE CONCERNS OF THAT GROUP MAY BE AS OPPOSE TO JUST ADULTS, CHILDREN, PREGINENT WOMEN-, YOU KNOW? >> RIGHT. >> THAT IF WE BROADEN THOSE EXAMPLES IT MIGHT HELP AT LEAST TO EXPLAIN WHAT WE THINK OF AS THE CONTEXT THAT MAY SAY, THAT'S WHERE WE--YOU KNOW, A SINGLE IRB MAY BE ABLE TO GET THE EXPERTISE OF THIS, OR WE MAY BE WANTING TO LOOK INTO THE LOCAL--AND IT STRUCK ME AND I WILL JUST NOTE, TOO, THE--IN THE DESCRIPTION OF THE MEDICAL MARIJUANA CASE, RIGHT, PERHAPS HAS EXPERIENCED IN THAT CASE, MAY NOT BE THE RIGHT PHRASING. [LAUGHTER] I'M SORRY THAT REALLY STRUCK ME AS I READ IT I THINK ACTUALLY THERE'S ANOTHER, NOT JUST A FUNNY POINT TO MAKE BUT IN TERPS OF--THAT'S REALLY ABOUT CONTEXT. RIGHT? BECAUSE A--A LOCALITY OR A STATE THAT HAS GONE THROUGH THE POLITICAL PROCESS TO SAY, WE THINK EITHER MEDICAL MARIJUANA OR MARIJUANA MORE GENERALLY IS OKAY IS VERY DIFFERENT THAN A STATE THAT HAS NOT GONE THROUGH THAT PROCESS AND THEREFORE, HOW THEY ARE GOING TO PERCEIVE IT AND WHAT ARE THE RISKS IN THAT MAY BE IMPORTANT. SO IT SEEMED TO ME LESS ABOUT THE EXPERIENCE LIKE THENYONATES VERSUS THE PREGNANT WOMEN AND MORE ABOUT WHAT'S THE CONTEXT AND I WAS VERY MUCH STRUCK IN THIS, I THINK GOES TO AVIVA'S POINT IS WHAT CAME UP IN HIV. RIGHT? SO WE WOULD SEE, NOT NECESSARILY IN CLINICAL TRIALS, BUT IN PREVENTION RESEARCH AND TRYING TO UNDERSTAND IN DIFFERENT POPULATIONS AND THEY WOULD BE MULTISTATE, MULTISITE PREVENTION STUDIES LOOKING AT YOU KNOW WHAT RISK FACTORS IN A VARIETY OF WAYS BUT CONTEXT IN WHICH THEY WERE HAPPENING WERE VERY DEPENDENT ON THE NATURE OF THE EPIDEMIC AND/OR THE PRIMARY DRIVERS OF THE EPIDEMIC IN PARTICULAR AREAS. SO AMONG MEN WHO HAVE SEX WITH MEN IN SOME CONTEXT, AMONG AFRICAN AMERICAN, HED ROW SEXUALLY DRIVEN AND VARIOUS OTHERS AND I REMEMBER SEEING IRB PROTOCOLS BUT IT WAS ISSUES ABOUT LANGUAGE. RIGHT? AND WHAT YOU NEEDED TO HAVE IN LANGUAGE IN SAN FRANCISCO WHEN YOU'RE GOING INTO THE CLUBS WAS QUITE DIFFERENT THAN IF YOU WERE IN THE MIDWEST AND GOING INTO OTHER CONTEXT. SO, SO THAT COULD BE THE EXAMPLE WHERE YOU REALLY NEED TO KNOW YOUR POPULATION AND WHERE IT MAY BE APPROPRIATE AND AGAIN--EXPANDING ON THOSE EXAMPLES MAY HELP EXPLAIN WHAT IS KIND OF A HARD LANGUAGE AT THIS POLITICAL CONTROVERSIAL SENSITIVE ISSUES WHERE REALLY SORT OF UNDERSTANDING SOMETHING ABOUT HOW IT PLAYS OUTED IN YOUR TOWN MAY BE IMPORTANT. I JUST WANT TO PICK UP ON 1 OF LESLY'S POINTS THAT IS IMPORTANT, I WOULD FOCUS ON THE RISKS, PARTICULAR KINDS OF RISKS. AS SOMEONE WHO DOES A LOT OF WORK ON THIS STUFF, I'M A LITTLE--I'M A LITTLE WEARY OF ENCOURAGING PEOPLE TO INVOLVE IRBs AND THE SINGLE IRB ISSUE WITH ISSUES OF LANGUAGE, BECAUSE I THINK THAT'S A DIFFERENT KIND OF A PROBLEM BUT I THINK THE RISKS ARE VERY CENTRAL TO WHAT THE IRBs ARE SUPPOSED TO BE DOING AND WHAT THE LOCAL CONTEXT MIGHT SUGGEST. AND I JUST PICK UP ON THAT 1 POINT OF YOURS WHERE YOU MENTION RISK AND I THINK THAT'S REALLY CRITICAL. >> IN TERMS OF LANGUAGE SOME OF THAT WAS ABOUT WHAT WAS GOING TO BE EFFECTIVE AND WHAT I'M THINK BEING WAS TRULY, IF WE GO WITH SORT OF THE LAND LANGUAGE THAT MANY OF US ON THE IRB WOULD BE MORE COMFORTABLE WITH, THAT IN FACT, YOU WOULD NOTED HAVE GOTTEN THE RESULTS THAT WOULD ACTUALLY BE SCIENTIFICALLY EFFECTIVE. AND THAT WAS AGAIN BEING PROVIDED INFORMATION ABOUT WHAT WAS EXPECTED WITHIN CONTEXT OF OUR POPULATION, NOT CONSENT FORMS BUT ACTUALLY WHAT ARE THE QUESTIONS THAT ARE BEING ASKED IN THE STUDY TRIEWMENT AND VARIOUS OTHER THINGS THAT WAS REALLY AGAIN HAVING INFORMATION FROM ABOUT THE PARTICULAR CONTEXT RATHER THAN THINKING YOU COULD DO THAT MORE GENERALLY. >> I'M KIND OF STRUGGLING A LITTLE BIT WITH THE MEDICAL MARIJUANA AND HOW THAT CONTEXT WOULD PLAY OUT IF THAT'S AN EXAMPLE WE WANT TO USE FOR A SENSITIVE TOPIC AREA FOR RESEARCH, RIGHT? WOULD THE IDEA BE THAT WOULD WANT RECOMMEND--WE WOULD NOT WANT TO USE A SINGLE IRB SO THAT IRBs IF STATE WHERE IS IT WAS LEGALIZED OR DEKRIM CRIMINALIZED MIGHT SAY YES GO AHEAD WITH THIS RESEARCH AND OTHER STATES WOULD SAY NO, YOU CAN'T DO IT HERE OR IS THERE SOME IDEA WHICH I THINK MIGHT BE PROBLEMATIC OR IS THERE SOME IDEA THAT WE WOULD WANT TO SHUNT THE REVIEWS TO STATES THAT ARE FAMILIAR WITH THIS BECAUSE THEY'VE, YOU KNOW HAD A REFERENDUM OR THOUGHT ABOUT IT MORE CAREFULLY AND SO HAVE THOUGHT THROUGH WHAT IS THE LAW ENFORCEMENT EFFECTS MIGHT BE OF RESEARCH PARTICIPANT IS BOUND TO HAVE, YOU KNOW THE DRUG ON THEIR CAR OR PERSON. I'M TRYING TO FIGURE OUT THAT PARTICULAR EXAMPLE WHAT DIRECTION IT GOES IN BECAUSE RIGHT, YOU MIGHT SAY THAT THAT'S A PERFECT EXAMPLE FOR SINGLE IRB REVIEW, INSTEAD OF TO HAVE MULTISTATE REVIEW BECAUSE THE STATES THAT HAVE DECRIMINALIZED OR LEGALIZED IT WOULD BE MUCH MORE FAMILIAR AND THEY HAVE THE EXPRTISE TO MOVE ON WITH THE SHUT AND HE WILL IT'S THE OPPOSITE OF HOW WE USE THE TO REVISIT THE FRAMING ISSUE. AND SO THE QUESTION IS REALLY, I DON'T THINK WE CAN ANSWER THAT QUESTION HERE. SOPHISTICATED I THINK IT'S IMPORTANT BUT THE QUESTION IS DO WE CONSIDER THAT SOMETHING THAT SHOULD BE CONSIDERED BY THE FUNDING AGENCIES, NOT KNOWING WHAT ANSWER WE WOULD RECOMMEND, I MEAN SO WE HAVE--WE HAVE 3 RECOMMENDATIONS SIZE PARTICIPANT CHARACTERISTICS LOCAL POPULATION AND THEN STUDY CHARACTERISTICS OF THE SENSITIVITY OR THE POLITICAL NATURE OF WHAT YOU'RE STUDYING, THOSE SEEM LIKE WORTH STATING BUT KIND OF-- >> VAGUE. >> BY EXAMPLES OR SOME OTHER DEFINITION THAT WE THINK ARE RELEVANT OF THINGS TO CONSIDER. >> DOES ANYONE FEEL THERE'S ANYTHING--SO EXAMPLES ARE A GOOD WAY TO FLUSH IT OUT AND I THINK THAT WILL BE CHALLENGING. CAN ANYONE PROPOSE THINGS THAT COULD BE MORE SPECIFIC THAN THOSE VERY GENERAL TERMS? THAT WOULD BE WORTH PUTTING IN THE HIGH LEVEL RECOMMENDATION BEFORE WE GET TO [INDISCERNIBLE]. SO I'M STRUGGLING WITH IT SO IT'S A CHALLENGE TO ALL OF YOU. >> SO THERE'S NO URGENCY ON THIS. I SEEM TO BE THE PUSH PERSONNING CERTAIN ISSUES TODAY AND I'M WONDERING, I THINK THIS A REALLY GOOD CONVERSATION AND I THINK THAT THERE'S A LOT OF GOOD FOOD FOR THOUGHT. I THINK IT WOULD BE WORTH TAKING THIS BACK TO THE SUBCOMMITTEES AND THERE ARE SOME PEOPLE FROM THE MAIN COMMITTEE WHO ARE ON THE SUBCOMMITTEES BECAUSE AS I HEAR THIS, I'M THINKING I WOULD LIKE TO SIT DOWN WITH LESLIE AND HOLLY AND SAND EXPE TALK ABOUT SOME OF THE MORE SPECIFIC INFORMATION. CAN WE BETTER CORRAL THESE ISSUES, AND PROVIDE BETTER EXAMPLES, I'M NOT SURE WE CAN DO THAT HERE RIGHT NOW OR OVER THIS DAY AND A HALF, AND SO, I WAS GOING TO SUGGEST WE TAKE THIS BACK TO THE SUBCOMMITTEES, WE TALK ABOUT IT MORE AND BRING IT BACK TO THE NEXT MEETING BECAUSE I THINK THAT, WE BASICALLY HAVE AGREED ON THE 3 MAIN CONSIDERATIONS. OR 3 MAIN CONSIDERATIONS, BUT WE NEED IS TO PROVIDE BETTER EXAMPLES AND BETTER GUIDANCE? SO THAT'S MY SUGGESTION. >> SO DOES ANYONE FEEL THERE'S MORE WORK WE CAN DO IN THE FULL COMMITTEE TODAY OR TOMORROW? >> COULD I JUST RAISE A WILD CARD ISSUE AND YOU CAN SAY SNOW. >> I'VE ALREADY RAISED 2, GO AHEAD. >> ONE OF THE THINGS THAT I AS AN INVESTIGATOR I'VE EXPERIENCED WHEN I HAD TO TAKE A STUDY THROUGH A HUNDRED ODD IRBs WAS THAT THE IRBs INVOLVED WERE INSTITUTIONS THAT WERE NOT TECHNICALLY ENGEAJED IN RESEARCH. THE INSTITUTIONS OPTED THE RESEARCH MORE AS A CONTROL FUNCTION AS A REQUIREMENT THAT THEY REVIEW AND AS PART OF AN ENGAGE SAID STUDY. --ENGAGED STUDY SO I KNOW THIS A WILD CARD AND PROBABLY NOT RELEVANT TO THIS BUT I WANTED TO MENTION THAT I WOULD LOVE IT IF AT SOME POINT WE SUGGEST THAD IRBs ACTUALLY DETERMINE WHETHER THEY'RE ENGAGED BEFORE THEY UNDERTAKE THE REVIEW. BECAUSE THAT IS AN XREAMLY INEFFICIENT--EXTREMELY INEFFICIENT PROCESS. >> SO NOTED. I'M NOT SURE--I MEAN I THINK IT'S A GREAT CAUTION. THE REGULATIONS TELL YOU WHAT YOU HAVE TO DO. THEY DON'T ALWAYS TELL YOU WHAT YOU CAN DO AND WHAT YOU WANT TO DO FOR YOUR OWN REASONS. YEAH. SO, I, YOU KNOW IN THIS CASE, IF YOU HAD A STUDY THAT WAS GOING UNDER REG LATTERLY MANDATED SINGLE IRB REVIEW COULD AN INSTITUTION FOR ITS OWN PURPOSES REVIEW IT SEPARATELY AND I DON'T THINK THAT'S PRECLUDED. I DON'T THINK FINDINGS WOULD HAVE ANY STANDINGS. --THERE ARE A LOT OF THINGS TO BE CONSIDERED. THIS HAS A LIMITED FOCUS. >> [INDISCERNIBLE]. >> I THINK WHAT WE'RE DOING IS--THAT DECISION'S ALREADY BEEN MADE. SO, GIVEN A REQUIREMENT FOR SINGLE IRB REVIEW OF MULTISITE RESEARCH WHAT ARE THE TYPES OF THINGS DO WE SUGGEST SHOULD BE CONSIDERED AS AN EXCEPTION TO THAT? SO I THINK WE'RE A STEP DOWN IN THE DECISION TREE. >> YEAH, I MEAN I GUESS SANDY, THE OTHER--WHERE I THINK THAT'S GOING IS BASICALLY, WE WOULD WOULD WANT TO DISCOURAGE EXTRA REGULATORY REVIEW. I THINK IT'S HARD TO JUST SAY THAT. --WE DON'T HAVE THE STATUS TO STOP THEM FROM REGULATORY REVIEW, I WOULD LEAVE IT UP TO THE PEOPLE FROM, YOU KNOW WHO EXPERIENCE THIS PROBLEM. >> I'M HUNGRY. >> SO, I THINK. >> YOU KNOW WE'RE GOING TO CONTINUE--IT SOUNDS LIKE WE'RE GOING TO CONTINUE THIS CONVERSATION. I HAVE TO SAY IT'S EVOLVING WITH THE TIMES WHICH IS KIND OF FUN BUT WE'RE NOT GOING TO GET IT DONE THIS TIME. >> SO, OKAY, SO, IS THIS--WHAT DO YOU WANT TO DO. >> LET'S GO BACK--AS YOU SUGGEST, LET'S GO BACK TO THE SUBCOMMITTEE, APPRISE THEM OF THE CONVERSATION, REFRAME IT AROUND CONSIDERATIONS AND. >> ADD EXAMPLES. >> ADD SPECIFIC EXAMPLES. >> DIG INTO IT. >> AND COMPEL THIS IF THEY CAN COME UP WITH ANYTHING MORE SPECIFIC, I'M NOT SURE THEY WILL BE ABLE TO COME UP WITH EXAMPLES WHICH WILL GIVE US AND DON'T THINK WE COULD ALL AGREEOT OUTCOME OF A PARTICULAR EXAMPLE OTHER THAN TO THINK ABOUT IT SO-- >> A FEW OTHER THINGINGS WE'RE TALKING ABOUT BUT I THINK ARE IMPORTANT IN THE DOCUMENT ARE JUST THINGS THAT SHOULD NOT COUNT AS RELEVANT CONTEXT. YOU KNOW THINGS THAT WE TOOK OUT ON PAGE 2 OF THE THIS DOCUMENT AND THEN THE OTHERS, THE OTHER POINT THAT IT'S NOT ALL OR NOTHING BECAUSE I THINK THAT DOES SEEM TO LEAVE THAT OUT AND I THINK IT'S HUGELY IMPORTANT RIGHT? THE CHOICE IS NOT 1 IRB VERSUS EVERY SITE VERSUS THEIR OWN IRB AND MAKE THAT CLEAR. THERE WILL BE VALUE OUT OF IT. >> I THINK THAT'S IMPORTANT WITH THE CAUTION THAT AVIVA RAISED THAT YOU DON'T WANT TO USE THAT AS AN INVITATION FOR PEOPLE TO SAY NOT ME. SO I THINK THAT DANGER HAS TO BE ACKNOWLEDGED EVEN THOUGH I THINK IT IS NOT ALL OR NOTHING. >> GOOD. >> SO HOLLY, ARE YOU ON THE SUBCOMMITTEES? I CAN'T REMEMBER? LESLIE? WOULD YOU LIKE TO BE AN AD HOC CONSULTANT. >> I WOULD LOVE TO BE AN AD HOC CONSULTANT. >> YOU HAD GOOD THOUGHTS. IT WOULD BE HELPFUL. >> ALL RIGHT, THEN, WE'RE BACK ON TRACK SORT OF AND IT'S LUNCH TIME. AND GIVEN THAT WE'VE DONE 1 OF OUR--I WAS GOING TO CALL FOR A SHORTER LUNCH TO MOVE THINGS ALONG BUT GIVEN THAT WE'VE ALREADY DONE 1 OF OUR POST LUNCH TOPICS, GO WILD. TAKE--WE'LL RECONVENE AT--WHAT DO WE HAVE. WE HAVE AN HOUR. WE WILL RECONVOAN AT 1:15. THANK YOU. I'M HAPPY TO BE BACK WITH THIS DOCUMENT TODAY. WE'LL START WALKING THROUGH IT JUST AS SOME BACKGROUND WE'VE BEEN SEEING THIS FOR SEVERAL MEETINGS NOW, AND AT THE LAST MEETING WE GOT THROUGH ALL BUT ONE CATEGORY THAT WAS JUST GETTING TRIPPED UP BECAUSE SOME LANGUAGE TAKEN FROM THE OLD LIST WASN'T FITTING WELL UNDER THE REVISED EXEMPTIONS AND FINAL RULE. WE TOOK IT BACK TO THE SUBCOMMITTEE, GOT SIGNIFICANT INPUT FROM THEM AND SACHRP MEMBERS THAT CONTRIBUTED TO IT. SANDRA, WE WERE HAPPY TO HAVE YOU ON ONE CALL BECAUSE YOU HIGHLIGHTED ISSUES WITH CATEGORY 10 AT THE LAST SACHRP MEETING. AND SO WHAT WE HAVE IN FRONT OF THIS IS LARGELY UNCHANGED FROM THE LAST TIME WE SAW IT BECAUSE MOST OF THE EFFORT HAS BEEN GOING INTO REFINING CATEGORY 10. SINCE IT WAS COMING BACK, THERE ARE A COUPLE OTHER MINOR TWEAKS MADE, I'LL POINT THOSE OUT AND THERE WERE A COUPLE POINTS THAT THE SUBCOMMITTEES ASKED SACHRP TO RECONSIDER AND SO I'LL ALSO TALK ABOUT TO. OTHERWISE THIS IS WHAT YOU SAW AND AGREED WITH LAST TIME. AS A REMINDER WE GOT THROUGH MOST LAST TIME AND LEFT THEM IN A GOOD PLACE. I'M NOT GOING TO -- UNLESS THERE'S A ENTIRE TO I'M NOT GOING TO SPEND TIME ON THE FRONT MATTER. IT WAS WHAT IT WAS BEFORE, FOR MINIMAL RISK RESEARCH ONLY, TALKING ABOUT THE FACT THAT THERE'S AN EXPECTATION THAT WHOEVER IS CONDUCTING THE EXPEDITED REVIEW DO THEIR WORK TO ENSURE THAT THE PROPOSED ACTIVITIES REALLY ARE MINIMAL RISK AND FIT ONE OF THE CATEGORIES AND THAT FRONT MATTER IS LARGELY UNCHANGED FROM BEFORE OTHER THAN MINOR EDITS, APPLICABLABILITY A, REVISED AS WE SHIFTED THINGS AROUND. OTHERWISE APPLICABILITY HAS STAYED THE SAME. WHEN IT COMES TO THE CATEGORIES I'LL TALK ABOUT THE THINGS WHERE THERE ARE SOME VERY SPECIFIC CHANGES, A COUPLE THINGS ARE TRACKED IN, SO FIRST OF ALL AS WE'VE GONE TO THE SUBCOMMITTEES POINTED OUT DISCREPANCIES AT TIMES BETWEEN WHAT THINGS WERE NON-INVASIVE UNDER CATEGORY 3 IN AND MINIMALLY INVASIVE UNDER CATEGORY 4, AT THE QUESTION OF A FEW PEOPLE BETWEEN LAST TIME AND NOW I MOVED THE REMOVAL OF PERMANENT TEETH DOWN BUT ACCIDENTALLY LEFT THEM HERE, I TRACKED THAT BEFORE LUNCH, THAT BELONGS FARTHER DOWN. THERE WAS SOME QUESTION ABOUT WHAT IS CURRENTLY H AT LINE 73, DENTAL PLAQUE AND CALCULUS, WHETHER THAT'S NON-INVASIVE OR MINIMALLY INVASIVE, I'M HAPPY TO HAVE IT IN EITHER PLACE. I THINK THE OTHER ONES ARE STRAIGHTFORWARD AND BELONG HERE, BUT OTHERWISE THAT SECTION IS RELATIVELY UNCHANGED. AND THEN 4, MINIMALLY INVASIVE, IT'S NOT TRACKED. HERE IS TEETH DOWN HERE. 4 BRINGS ME TO WHERE THE SUBCOMMITTEES ASKED FOR RECONSIDERATION OF THIS EXCLUSION OF CHILDREN FROM CATEGORY 4 ACTIVITIES, AT LEAST THE FOUR B ACTIVITIES HERE. THERE WAS A LOT OF CONCERN THAT WE WERE REALLY ELIMINATING WHAT WERE MINIMAL RISK COLLECTION ACTIVITIES FOR PURPOSES IT SEEMS ARBITRARY FROM CHILDREN, WHEN OTHER CATEGORIES SEEM TO ALLOW THEM. YOU KNOW, JONATHAN GREEN IS NOT HERE. HE'S A PEDIATRICIAN IN FAVOR OF MAKING THIS CHANGE INPUT FROM BOSTON, YOU KNOW, THEY WERE MAKING AN ARGUMENT THAT WE WERE REALLY ELIMINATING USEFUL PROCEDURES FROM EXPEDITED REVIEW THAT WOULD NOT HAVE -- THAT IN THEIR RECKONING DIDN'T MAKE SENSE, THAT ALSO REPEATS IN CATEGORY 5 AGAIN, AT I THINK SEVERAL MEETINGS AGO WE ADDED IN THIS LIMITATION THAT IT ONLY BE IN IN ADULTS, SUBCOMMITTEES THOUGHT THAT WE WERE BEING TOO RESTRICTIVE. SO THOSE ARE THE CHANGES THERE. WE CAN COME BACK AND TALK ABOUT THESE. THERE'S NOT THAT MANY MORE CHANGES. THIS IS ALL THE SAME FROM BEFORE. SORRY FOR ALL THE SCROLLING. NUMBER 10 WE CAN COME BACK AND DISSECT IN A FEW MINUTES BUT THIS HAS BEEN RADICALLY REWRITTEN, THE EXAMPLES ARE GONE, THAT WAS THE CONSENSUS OF SUBCOMMITTEES. RADICAL IN THE SENSE, WELL, RADICAL BECAUSE IT LOOKS NOTHING LIKE BEFORE BUT WAS REWRITTEN TO MATCH THE FINAL RULE AS WRITTEN AND MAKE SURE THAT THE -- WHAT WE'RE TRYING TO INCLUDE IN HERE AREN'T COVERED BY THAT EXEMPTION ALREADY. WE ACTUALLY HAD TROUBLE COMING UP WITH THINGS THAT WOULD FIT IN THAT BUT I THINK WE'VE GOT A PARAGRAPH HERE THAT WORKS. 11 IS UNCHANGED. 12 IS UNCHANGED. AND THEN 13 AND 14 USED TO BE SQUISHED TOGETHER. BUT BECAUSE THEY WERE TRYING TO CARVE OUT THINGS THAT WERE NOT EXEMPTED UNDER 104(D)(4) OR D-8, THEY DIDN'T MAKE SENSE, OTHERWISE THE LANGUAGE IS THE SAME, MANATEE TO ADDRESS SPECIFIC PARTS OF EACH OF THOSE EXEMPTIONS THAT WOULDN'T ALLOW YOU TO EXEMPT IT. BUT STILL MAY BE EXPEDITABLE. THAT'S THE ONLY CHANGE. IT MADE SENSE TO PULL THEM APART SINCE THEY DEAL WITH DISTINCT CATEGORIES. LET ME JUST BACK UP TO 4 AND 5 AND ASK FOR COMMENTS ABOUT THIS IDEA OF PUTTING -- REMOVING THE RESTRICTION THAT THESE TWO CATEGORIES ONLY APPLY TO ADULTS. >> IS THAT DIFFERENT IN CHILDREN UNDER 2,3, 4 YEARS. >> GOOD QUESTION. IF I ASK SCROLL DOWN THEIR WE ADOPTED THIS DESCRIPTION OF WHAT WOULD MAKE THE EXTENSION OF ANESTHESIA MINIMAL RISK BASED ON POLICIES AT CHILDREN'S HOSPITAL IN BOSTON WHERE THEY TRIED TO COME UP WITH A STRUCTURE FOR DETERMINING THAT. I'M NOT A PEDIATRICIAN OR ANESTHESIOLOGIST, I DON'T HAVE AN OPINION, THAT IS THE POLICY WE'RE WORKING OFF OF. WE'VE TRIED TO DEFINE IT HERE. SHOULD THIS LIST BE ADOPTED BY SACHRP AND TURNED INTO THE BASIS OF STARTING POINT FOR CHANGING THE RULE I SUSPECT THIS IS ONE THING THAT WOULD UNDERGO FURTHER SCRUTINY THROUGH THE PROCESS OF TURNING THIS INTO A FINAL EXPEDITED REVIEW LIST. >> I THINK IT'S GOING TO BE VERY HELPFUL TO HAVE GUIDANCE ON AMOUNT OF TIME AND I WOULD ARGUE THE TIME COULD BE LONGER FOR ADULTS AND THE TIME IN CHILDREN MAYBE SHOULD BE PREDICATED ON AN UNDERSTANDING OF HOW LONG THE CLINICAL PROCEDURE ANESTHESIA TIME IS. >> RIGHT. >> OTHER THOUGHTS ON PEDIATRIC POPULATIONS IN 4 AND 5? ALL RIGHT. THEN I'M GOING TO GO DOWN TO NUMBER 10. WE CAN LOOK AT THAT TOGETHER. SO AGAIN IN THE PAST IF YOU REMEMBER IT, IT CRAMMED IN LOTS OF DIFFERENT BOTH -- BOTH THIS IDEA OF, YOU KNOW, WE HAD EXAMPLES AND IT REALLY TRIED TO BE VERY DESCRIPTIVE IN THE KINDS OF THINGS IT WAS ATTEMPTING TO ALLOW TO BE EXPEDITED. WE'VE STRIPPED IT BACK. IT'S RESEARCH THAT INVOLVES INTERACTION INVOLVING EDUCATIONAL, COGNITIVE AND DIAGNOSTIC. 2 IS INTERVIEW PROCEDURES OR OBSERVATIONAL PUBLIC BEHAVIOR NOT ELIGIBLE UNDER 104(d) 2. WE TIED IT TO WHAT COULDN'T BE EXEMPT EITHER BECAUSE THERE ARE RISKS TO SUBJECTS OTHER THAN INFORMATIONAL RISKS BECAUSE THAT'S PART OF THE EXEMPTION OR BECAUSE THE INFORMATIONAL RISKS ARE NOT ADDRESSED SPECIFIED AND YOU 104(d) 2, 1-3. IN APPLYING THAT PART OF THIS EXPEDITED CATEGORY, THERE WILL NEED TO BE GUIDANCE DEVELOPED TO TALK ABOUT HOW YOU DO THAT OR THE PERSON WILL HAVE TO BE AWARE OF WHY IT FAILED THE TEST AT 104(d)2. THAT'S NOT EVEN IN OUR CURRENT REGULATORY FRAMEWORK, THAT'S NOT UNUSUAL. THERE ARE THINGS THAT CAN'T BE EXPEDITED, THEY ARE CALLED OUT OR FAILED THE EXPEDITED TEST AND ARE ELIGIBLE FOR EXPEDITED REVIEW, CITING NEW PROCESS REGULATIONS BUT IRBs DO THIS ALL THE TIME WITH THINGS THAT DIDN'T PASS THE TEST FOR EXEMPTION. AND THEN NUMBER 3, OTHER DATA COLLECTION PROCEDURES WHERE THE SUBJECT PROVIDES SELF REPORTS FOR PURPOSE OF RESEARCH AND/OR MAY CHOOSE WHAT DATA TO PROVIDE, 4 NON-INVASIVE PHYSICAL OR BEHAVIORAL TASKS OR MAN PLACE OF THE SUBJECT'S ENVIRONMENT AND 5 OBSERVATIONS OF INDIVIDUAL OR GROUP BEHAVIOR WHERE SUBJECT IS VOLUNTARY PARTICIPANT IN BEHAVIOR, AWARE OF DATA BEING COLLECTED. THOUGHTS, COMMENTS, CONCERNS? >> SUBGROUP 23 OTHER DATA COLLECTION IS TO CAPTURE THINGS THAT MIGHT NOT HAVE BEEN EXPLICITLY NAMED IN THE PREVIOUS -- >> THAT'S CORRECT. >> SO COMPUTER-ASSISTED INTERACTION WOULD BE 104(d) 3 PROBABLY BUT ASSESSMENTS WOULD FALL UNDER THIS. I'M JUST NOT SURE WHAT WE WERE THINKING ABOUT THAT. >> I THINK IN THE BIG PICTURE, OUR CONCERN -- BECAUSE THERE WAS TALK, MAYBE WE DON'T NEED THIS CATEGORY AT ALL BECAUSE OF HOW, YOU KNOW, THE EXEMPT CATEGORIES HAVE BEEN REWRITTEN. BUT THEN THERE'S ALWAYS THE CONCERN IF WE JUST SORT OF THREW IT OUT, THAT INVARIABLY SOMEBODY WOULD SAY I'VE GOT THIS THING, IT REALLY DOESN'T FIT THE EXEMPTION BUT NOW I ALSO CAN'T EXPEDITE IT. SOME ARE ALMOST INTENTIONALLY VAGUE, OR WE WANTED TO PUT A PLACE HOLDER ASSUMING SOMETHING WOULD COME ALONG THAT IN THIS CASE WOULD FIT NUMBER 3, BUT THIS WAS ABOUT AS SPECIFIC AS WE COULD GET WITH THESE PARENTHETICAL EXAMPLES. THIS IS PART OF THE REASON WE NO LONGER HAVE ATTACHED EXAMPLE LIST FOR THIS CATEGORY BECAUSE IT WAS REALLY A STRUGGLE TO COME UP WITH THINGS THAT WOULDN'T -- WE COULDN'T PLUG INTO EXEMPTIONS AND RATHER THAN KILL OURSELVES COMING UP WITH EXAMPLES FOR THE SAKE OF HAVING EXAMPLES THE CONSENSUS WAS TO SCRAP THEM. >> SO 4, NON-INVASIVE PHYSICAL TASK, SHOULD THOSE BE UNDER 11 OR 10, THOSE SOUND LIKE BENIGN RATHER. IT'S A SMALL POINT. >> YEAH, I DON'T -- I'VE LOOKED SO MANY TIMES I FORGET HOW WE GOT TO THE FINAL LANGUAGE, TRYING TO REMEMBER IF THERE WAS A RATIONALE WHY WE DECIDED TO HAVE NUMBER 4 IN HERE, MAYBE THE NON-INVASIVE THAT MADE IT DIFFERENT BUT WE STILL SAY BEHAVIORAL AS WELL SO -- >> I MEAN, AGAIN, AS LONG AS DONE.SOMEWHERE, IT GETS THE JOB- >> AS LONG AS IT'S SOMEWHERE IT GETS THE JOB DONE AND AT THE END OF THE DAY I SUPPOSE IF SOMEBODY HAD A RESEARCH PROTOCOL AND THEY SAID, WELL, GEE, I DON'T KNOW IF IT'S 10 OR 11, AS LONG AS IT'S ONE OF THOSE I DON'T THINK YOU'RE GOING TO GET IN TOO MUCH TROUBLE IF YOU PICKED ONE OVER THE OTHER. >> (INAUDIBLE) (OFF MICROPHONE). >> AND I'M -- YEAH. >> (INAUDIBLE). >> YEAH. >> (INAUDIBLE). >> NO, I AGREE. THIS IS REALLY HARD TO CLEANLY PARSE THESE AND NOT LEAVE HOLES. THAT'S WHAT THE SUBCOMMITTEES HAVE BEEN CHALLENGED BY. THIS IS DIFFERENT THAN OUR TYPICAL RECOMMENDATION, THIS IS THE EXPEDITED REVIEW LIST, NOT THE FINAL. THIS WILL GO THROUGH MUCH MORE REVIEW AND WHAT WE PRODUCE WILL INFLUENCE THAT BUT IS NOT THE FINAL DOCUMENT SO I DON'T THINK IT HAS TO BE PERFECT. OTHER THOUGHTS OR CONCERNS LOOKING AT THIS, WOULD PEOPLE BE COMFORTABLE USING THIS, IF IT, SAY, WAS THE FINAL DOCUMENT? >> (INAUDIBLE). >> I THINK WE'RE AT A PLACE WE COULD STOP. >> I THOUGHT MARK GOT OFF EASY. I'M WAITING FOR THE OTHER SHOE TO FALL. NO, I MEAN WE SPENT A LOT OF TIME ON THIS. THE FACT THAT WE'RE NOT GETTING A LOT OF COMMENTS DOESN'T BOTHER ME, PLENTY OF COMMENTS OVER THE LAST SEVERAL MEETINGS. THE SUBCOMMITTEES ARE HAPPY WE'VE GOT GOTTEN TO A PLACE WHERE IT MAKES SENSE IN THE FRAMEWORK OF THE NEW RULE, WE HAVEN'T LEFT ANY GAPS THAT WE WOULD REGRET, IF IT WERE TO BECOME THE RULE, THIS CATEGORY, THAT WE LEFT A GAP THAT ISN'T ADDRESSED OTHERWISE. AND SO I'M CERTAINLY HAPPY THAT PEOPLE SEEM TO BE SATISFIED WITH IT. >> I'LL MAKE ONE OTHER OBSERVATION WHICH IS I THINK THAT WE'RE STILL STRUGGLING WITH THE CHANGE FROM AN EXPLICIT MINIMAL RISK DETERMINATION TO A PRESUMPTION, AND THEN DETECTION, IF IT'S NOT, THE CONSEQUENCES OF THAT. TO ME, REALLY I'M COMFORTABLE WIT ALL THIS ASSUMING SOMEONE IS ACTUALLY MAKING THAT ASSESSMENT, WHETHER THEY HAVE TO DOCUMENT OR NOT. WE HAVE THAT IN BOLD. THERE'S NOTHING ELSE WE CAN DO. WE'RE VERY EXPLICIT BUT I THINK IT IS, YOU KNOW, THE ALTERNATIVE TO MY MIND IF WE REALLY WANTED TO MAKE THESE CLEANLY ALL MINIMAL RISK IT WOULD REDUCE THEM SO MUCH THERE WOULD BE A LOT LESS RESEARCH THAT COULD BE EXPEDITED. IT WILL BE INTERESTING TO SEE THE FINAL LIST. >> WE'VE DONE THE WORK THAT WE CAN ON THE FRONT END TO CALL THAT OUT REPEATEDLY. I THINK, YOU KNOW, ONCE IT GETS TO THE POINT OF WAY DOWN THE ROAD WHEN THERE IS SOME IMPLEMENTATION THEN IT BECOMES A MATTER THERE MAY NEED ADDITIONAL GUIDANCE ON APPLYING EXPEDITED REVIEW CATEGORIES IN THE NEW GENERAL FRAMEWORK. AND MAYBE WE'LL GET CALLED BACK TO HELP WORK ON THAT AT SOME POINT. >> JERRY, ANY THOUGHTS, IS THIS USEFUL TO YOU? >> ABSOLUTELY. AS YOU NOTED, AGAIN, THIS IS GOING TO BE A COMPLICATED DOCUMENT IN TERMS OF HOW IT WILL ULTIMATELY GO OUT TO THE PUBLIC IN TERMS OF ASKING THEM TO COMMENT ON SOMETHING. I DON'T THINK WE KNOW THAT AND CLEARLY THERE WILL BE OTHER AGENCY PLAYERS IN TERMS OF THIS. BUT NO, VERY HELPFUL. THANK YOU. >> ANY LAST COMMENTS BEFORE I CALL FOR A VOTE ON ENDORSING THIS AS A SACHRP RECOMMENDATION? >> A DRAFTING QUERY FOR ITEM 10, SUBITEM 5 INTENDED TO BE INDIVIDUAL AND GROUP OR "OR," INCLUSIVE OF BOTH CATEGORIES? >> PROBABLY SUPPOSED TO BE AN "OR." >> THANK YOU. >> THANK YOU. >> ALL RIGHT. THEN I WOULD INVITE A MOTION TO APPROVE THIS AS A SACHRP RECOMMENDATION. SECOND. MOVED AND SECONDED TO APPROVE THIS DOCUMENT WITH THE CHANGES YOU MADE NOW AS FINALIZED RECOMMENDATION. DISCUSSION? ALL IN FAVOR OF APPROVAL SAY AYE. >> AYE. >> MOTION PASSED. >> I CLICK SAFE. WITH A NEW FILE NAME. >> I SHOULD HAVE ASKED ANYTHING ABSTAINING OR OBJECTING? THANK YOU. >> ALL RIGHT. THAT'S ALL I GOT, STEVE. >> ALL RIGHT. LET'S SEE, WHERE DOES THAT LEAVE US? IS THERE PUBLIC COMMENT? I KNOW IT'S A LITTLE BIT -- SO PUBLIC COMMENT WAS SCHEDULED AT 4:15. SO IT'S A LITTLE BIT UNFAIR TO THE PUBLIC IF THEY HAD PLANNED TO BE HERE AT 4:15. ON THE OTHER HAND, NOW IS THE TIME. SO -- AND THERE'S ALWAYS TOMORROW IF WE MISS IT TODAY. SO IS THERE ANYONE FROM THE PUBLIC WHO WISHES TO MAKE COMMENTS ON TODAY'S PROCEEDINGS OR OTHER ISSUES? ALL RIGHT. THANK YOU. I GUESS THEN I WOULD ENTERTAIN A MOTION TO ADJOURN. NO ONE'S COMFORTABLE MAKING THE MOTION. [LAUGHTER] SO I'M NOT -- ALL RIGHT. WELL, I WILL THEN -- IF THERE ARE NO OBJECTIONS I'LL DECLARE US ADJOURNED.