WELCOME, I AM Dr. KATHERINE BLIZINSKY, POLICY DIRECTOR HERE AT THE ALL OF US RESEARCH PROGRAM AND I HAVE THE DISTINCT HONOR OF WELCOMING YOU TO THE ALL OF US ELSI WORKSHOPS. THIS HAS BEEN A LONG TIME IN THE MAKING. ALTHOUGH ELSI RESEARCH HAS ALWAYS BEEN A PART OF THE RESEARCH IN MEDICINE AND PROGRAM VISION, IT HAS NOT ALWAYS BEEN REGISTERED IN THE PROGRAM. AND THAT CHANGES TODAY. SOMETHING I KNOW MANY OF YOU HAVE BEEN WAITED FOR SINCE THE FIRST PRONOUNCEMENT OF THE DECISION AND CERTAINLY SOMETHING I HAVE BEEN WORKING TOWARDS DURING MY TIME IN CONGRESS AND TWO YEARS WITH ALL OF US WHICH IS WHY STANDING IN FRONT WITH YOU TODAY LOOKING OUT ON THIS AUDIENCE AND KNOWING WE HAVE SO MANY PEOPLE ONLINE, I AM IN SUCH A SENSE OF AWE WITH THANKFULNESS THAT WE HAVE REACHED THIS POSITION. I HAVE THE PLEASURE TO WORK WITH STAFF ON A DAILY BASIS AND WE ARE JOINED BY SOME OF THE FINEST MINDS THAT THE RESEARCH COMPANY HAS INTRODUCED, THE PROFESSIONAL WORK OF ME AND MANY OTHERS. WE ARE MOVERS AND SHAKERS OF THE FEDERAL GOVERNMENT, PEOPLE WHO IN MANY WAYS PUSH US TO GREATER HEIGHTS OF KNOWLEDGE AND UNDERSTANDING. IMPORTANT, WE ARE GRACED WITH A GROUP OF PEOPLE WITHOUT WHOM THERE WOULD BE NO ALL OF US, ALL OF OUR PARTICIPANT FAMILY. THESE ARE PEOPLE WHO HAVE GENEROUSLY SHARED NOT >>> GOOD MORNING, EVERYONE, HOW ARE YOU? WE ARE SO EXCITED TO SEE YOU HERE TODAY, HOPEFULLY MANY MORE NEW FRIENDS FOR ME PERSONALLY AND WE HOPE IN THE NEXT TWO DAYS WE WILL BE HERE TO DO A LOT OF LEARNING FOR ALL OF US, NOT JUST THE PROGRAM ITSELF, ROBUST DISCUSSIONS AND THE BEGINNING OF CONVERSATIONS FOR THE WORKSHOPS. WE WILL HAVE INFORMATION ON THE ALL OF US PROGRAM BEFORE WE ALL DIVE IN FOR THE AFTERNOON SESSIONS THIS AFTERNOON AND MOST% OF TOMORROW BUT IN THE NEXT FEW MINUTES, I WOULD LIKE TO GIVE YOU A QUICK OVERVIEW OF THE WORKSHOP, GOALS, ACTIVITIES AND HOPEFULLY SOME OF THE EXPECTED OUTCOMES. ALL RIGHT, SO AS KATE SAID, CONSIDERATIONS OF ETHICAL, LEGAL GAG, SOCIAL ISSUES -- LEGAL, SOCIAL, ETHICAL ASPECTS CONTINUE TO BE THE PRIMARY ISSUES AND CONTINUE TO GROW SO DURING THE PROGRAM TODAY, THE EFFORTS TO ASSESS THE SOCIAL RESEARCH USING THE DATA AS WELL AS THE PROGRAM ITSELF IN BROADER RESEARCH COMMUNITY AND HERE ARE SOME OF THE REASONS WE BELIEVE THIS SEARCH IS CRITICAL. THESE ARE NOT NEW TO MANY IN THE ROOM BUT I WILL RUN THROUGH A COUPLE OF THEM. NATURE OF ALL OF THE RESOURCE RAISE ETHICAL, SOCIAL AND RESEARCH ISSUES. RESPONSIBLE USE OF THE RESEARCH REQUIRES THAT THESE ISSUES ARE ADDRESSED SYMPTOMATICALLY AND EARLY -- SIT SYSTEMATICALLY AND BEYOND IN AN INDIVIDUAL WAY. WE ALSO BELIEVE THE ENERGY PERSPECTIVES SHOULD INFORM THE PROGRAM AND RESPONSIBLE USE OF THE ALL OF US RESOURCES IN AN ONGOING WAY AND FINALLY, EVOLVING TECHNOLOGY, THINK MACHINE LEARNING, DIGITAL AND SMART PHONE APPS, DATA PARADIGM PERFECTION AND LANDSCAPES REQUIRES WE ANTICIPATE THESE ETHICAL LEGAL SOCIAL ISSUES. SO TO THAT END, WE HAVE BROUGHT TOGETHER TODAY A GROUP OF EVERY DIVERSE ELSI EXPERTS TO INSURE A WIDE VARIETY OF COMMUNITIES ARE REPRESENTED. WE WANT TO PROVIDE ATTENDEES WITH INFORMATION ABOUT THE ALL OF US RESEARCH PROGRAM TO KICK-START THOSE CONVERSATIONS AND DIVE INTO THE WORK WE WILL DO IN OUR WORKING GROUPS LATER IN THE WORKSHOP AND MOST IMPORTANT, WE WOULD LIKE TO ELICIT FEEDBACK FROM THE ALL OF US DATA RESEARCH TO ACHIEVE THE GOALS. SO WE BROUGHT, AS KATE MENTIONED, ELSI EXPERTS FROM THROUGHOUT THE PROGRAM, LOTS OF EARLY CAREER RESEARCHERS SO WE HOPE YOU WILL BE EXCITED ABOUT DOING RESEARCH FOR ALL OF US AND ON ALL OF US, NIH AND STAFF, PEOPLE WITH DEEP EXPERTISE IN THINKING OF ELSI ISSUES AND WHOM WE HOPE TO FORM PARTNERSHIPS WITH AS WE ADVANCE THE RESEARCH AND WE ARE SO HONORED TO HAVE ALL OF OUR ANTICIPATED AMBASSADORS TODAY WHO NOT ONLY BRING THE EXPERIENCE OF THE PARTICIPANTS BUT THE CHANNEL OF CONCERNS, REVIEWS AND COMMUNITIES THEY WORK SO CLOSELY WITH TO INFORM THE QUESTIONS WE WILL BE WORKING ON AND MOST IMPORTANT, WE HAVE ALL OF THE STAFF HERE, ALL OF WHO HAVE BEEN COMMITTED TO BRING THIS WORKSHOP TOGETHER AND DONE A FANTASTIC JOB WORKING REALLY HARD AND I HAVE HAD THE GREAT TIME TO GET TO KNOW OVER JUST A MONTH NOW IN BRINGING THIS WORKSHOP TOGETHER SO WE ARE ALL VERY, VERY EXCITED AND HONORED TO BE HERE. TO PROVIDE OUR ATTENDEES A DEEPER UNDERSTANDING OF THE ALL OF US RESEARCH PROGRAM, WE WILL HAVE A SERIES OF TALKS AFTER ME, STARTING WITH OUR ASSOCIATE DIRECTOR, STEPHANIE DEVANEY THROUGH WHICH YOU WILL LEARN ABOUT THE SCIENTIFIC ROAD MAP, THE DATA PLAN FOR FROM ALL OF US AND THE RESOURCE SOURCES ALL OF US WILL DEVELOP AND I GUESS THE LAST BUT NOT THE LEAST, I SHOULD SAY PERHAPS MOST IMPORTANT, TODAY IN THE NEXT TWO DAYS, WE ARE REALLY HERE TO SOLICIT YOUR FEEDBACK FOR THE DATA RESOURCE OF ELSI RESEARCH AND PROGRAM. HERE IS HOW WE THOUGHT WE WOULD BEGIN TO ASK YOU FOR YOUR VALUABLE FEEDBACK BASED ON THE YEARS OF EXPERTISE YOU BRING TOGETHER. WE USE THESE THREE FRAMING QUESTIONS OF HOW WE ARE APPROACHING THE WORKSHOP. FIRST, WHAT ARE THE CAREERS THAT WE WOULD LIKE TO STUDY USING THE ALL OF US PROGRAM AS A PLATFORM ITSELF. WHAT TYPES OF DATE TO PROGRAMS DO WE HAVE AND WHAT TOOLS WOULD IT HELP TO PROVIDE GOING FORWARD? SO WITH THESE QUESTIONS IN MIND, YOU WILL HEAR A LOT MORE DETAILS LATER IN THE DAY ABOUT HOW WE BEGIN TO ADDRESS THESE QUESTIONS AND SO THE ACTIVITIES TODAY WILL HELP US TOGETHER DEVELOP USE CASES TO IDENTIFY THE STRENGTHS AND WEAKNESSES OF THE ALL OF US RESOURCES, IDENTIFY ADDITIONAL DATA COLLECTION NEEDS TO ENABLE THE ELSI RESEARCH GOING FORWARD AND IDENTIFY AN LIT AL AND STATISTICAL NEEDS OF ELSI RESEARCH GOING FORWARD. SO YOU HAVE ALL HEARD HOW WE'RE GOING TO DO THIS, BY WORKING IN GROUPS, AND MOST OF YOU WERE ASKED TO GIVE YOUR CHOICES OR PREUFRPBSZ OR PREFERENCES ON HOW YOU WANT TO BE IN THESE WORKING GROUPS AND BRING TOGETHER A SET OF QUESTIONS WE CAN WORK ON BRINGING OUR JOINT EXPERTISE TO PLAY. SO THE THREE WORK STREAMS YOU HAVE BEEN HOPEFULLY ASSIGNED TO AND HOPEFULLY YOU GOT YOUR PREFERRED CHOICES, ARE HEAVILY NOT SEPARATED BUT SEEING THESE AS POROUS GROUPS IN MANY WAYS, EACH WITH A CORE PURPOSE. THE FIRST GENOMICS, RELATED TO SIGN AND TRANSGENOMIC RESEARCH INCLUDING COLLECTING AND ANALYZING DNA FROM UNDER REPRESENTED POPULATIONS. THE LEGAL POLICY WILL FOCUS ON THE INFLUENCE AND REGULATORY FRAMEWORK ON THE PRACTICE OF RESEARCH INCLUDING THE CHANGING PRIVACY LANDSCAPE, LEGAL SUPPORTS FOR AND BARRIERS WHICH WE ALL ANTICIPATE TO ENABLE POLICY MAKING AND FINALLY, TO CONCENTRATE ON THE SOCIAL, ENVIRONMENTAL AND OTHER FACTORS ON HEALTH INCOMES. THESE COULD INCLUDE TOPICS ON ACTIONABLE AND COLLECTION OF SOCIAL DATA AND THE EFFECT OF SUCH RESEARCH ON VULNERABLE POPULATIONS. SO AT THE END OF ALL THIS HARD WORK WHICH I AM SURE WILL BE VERY EXCITING AND ROBUST DISCUSSIONS WE WILL HAVE OVER THE NEXT COUPLE OF DAYS, WE HOPE THAT THESE WILL BE SOME OF THE PRIMARY OUTCOMES OF THIS WORKSHOP. WE EXPECT TO HAVE A MEETING SUMMARY THAT WILL BECOME PUBLIC, A WHITE PAPER WHICH WILL ESSENTIALLY COMBINE OR SYNTHESIZE THE LEARNINGS FROM THE RESEARCH USED CASE STUDIES THAT WE WILL ALL DEVELOP TOGETHER AND THEN BASED ON THESE PRODUCTS, WE ANTICIPATE THAT WE WILL DEVELOP GUIDANCE FOR PRIORITY SETTINGS WITHIN THE ALL OF US PROGRAM AND FOR WORKING WITH OUR PARTNERS AT NIH AND OTHER ORGANIZATIONS. SO WITH THAT, I AM GOING TO STOP AND GIVE BACK FIVE MINUTES TO EVERYBODY, TAKE A COUPLE OF QUICK QUESTIONS AND SAY AGAIN THANK YOU SO MUCH FOR BEING HERE, THOSE JOINING US REMOTELY, AND FOR YOUR TIME AND COMMITMENT TO BASICALLY DIVING INTO THIS PROCESS TOGETHER AND I REALLY HOPE IT IS THE BEGINNING OF NEW CONVERSATIONS THAT WILL CONTINUE WELL PAST THESE TWO DAYS. THANK YOU SO MUCH. [APPLAUSE] ALL RIGHT? OKAY, WELL GOOD. >> THANK YOU, Dr. SULHASHINI CHANDRASEKHARAN. ALL RIGHT, SHE SAID IT RIGHT. THANK YOU. NOW I GET TO INTRODUCE MY BOSS, MY FRIEND, Dr. STEPHANIE DEVANEY. >> I AM JUST PUTTING UP THIS. >> OKAY, GOOD MORNING, EVERYONE. WE ARE AHEAD OF SCHEDULE BUT I WILL TRY TO TAKE CARE OF THAT. I WILL TRY NOT TO BE TOO LONG BECAUSE THERE IS SO MUCH CONTENT FOR THE NEXT FEW HOURS, I WANT TO USE THAT TIME TO BUFFER BUT I WANT TO SAY FIRST AND FOREMOST, THANK YOU FOR TRAVELING OUT HERE ON A MONDAY AND SPENDING TWO DAYS WITH US. WE HAVE BEFORE THE BEGINNING OF THE INITIATIVE, BEFORE IT WAS AN INITIATIVE, BEFORE CONGRESS GAVE US ANY FUNDING WAY BACK WHEN IT WAS JUST AN IDEA, THE WORKING GROUP TO THE ADVISORY COMMITTEE OF THE NIH DIRECTOR WAS JUST STARTING TO WRITE THE IDEA ON PAPER. ETHICAL RESEARCH HAS BEEN A STRONG FOCUS FOR THE PROGRAM. WE HAVE ALWAYS FELT LIKE THIS PLATFORM CAN ENABLE THE RESEARCH TO SUPPORT OUR UNDERSTANDING OF HOW RESEARCH AFFECTS FOLKS IN THIS COUNTRY BUT ALSO TO USE THAT PLATFORM TO HELP PUSH FORWARD IN CONCEPTS AND PRIORITIES AROUND ETHICAL RESEARCH. SO I AM EXCITED TO BE HERE FINALLY. IT DOES FEEL AS THOUGH IT HAS BEEN A LONG TIME BUT IN FACT, WE'RE STILL JUST AT THE BEGINNING SO THIS IS EXACTLY THE TIME IT HAVE THIS WORKSHOP AND HAVE YOU HELP US SET SOME PRIORITIES. SO THE CONCEPT THAT WE ARE PUSHING FORWARD HERE AT THE ALL OF US RESEARCH PROGRAM IS IF WE CAN HARNESS THE RIGHT DATA AND INFORMATION ACROSS A DIVERSE GROUP OF ONE MILLION OF US AS PARTNERS -- AND THAT IS CRITICAL FOR US -- OVER MANY YEARS, WE CAN LEARN THINGS ABOUT HUMAN HEALTH THAT WILL BE GAME-CHANGING. OUR MISSION AT THE HIGHEST LEVEL IS TO ACCELERATE HEALTH RESEARCH AND MEDICAL BREAKTHROUGHS, ENABLING SR*EUDIZE INDIVIDUALIZED TREATMENT FOR ALL OF US. THE FIRST WE'RE FOCUSSED ON IS NURTURING RELATIONSHIPS WITH ONE MILLION OR MORE PARTICIPANTS. THESE ARE THE PARTICIPANTS WE JOIN IN OUR STUDY, COME FROM ALL OVER THE COUNTRY AND I WILL TALK A LITTLE BIT MORE ON WHAT THEIR JOURNEY TO OUR PROGRAM IS LIKE. ULTIMATELY THEN WITH THE GENEROSITY OF WHAT THOSE FOLKS ARE SHARING WITH US, TO DELIVER THE BROADEST RESEARCH MEDICAL SET TO OPEN KEY QUESTIONS IN HEALTH AND TO CATALYZE THE ECOSYSTEMS OF RESEARCHERS AND FUNDERS HUNGRY TO USE AND SUPPORT THIS PROGRAM. WE ALSO ESTABLISH CORE VALUES AND THIS IS REALLY IMPORTANT BECAUSE AS YOU BUILD A PROGRAM, WHAT YOU LEARN IS IT IS REALLY SET HELPFUL TO HAVE A SET OF POLICIES THAT WILL DESIGN AS WELL AS CHANGE THE COURSE OF THE PROGRAM AND SO WE HAVE ESTABLISHED THESE, THEY ARE HANGING IN OUR OFFICE, HAVE THEM ALL AROUND US AND WE COME BACK CONSTANTLY AND ASK OURSELVES ARE WE STILL BEING TRUE TO THE CORE VALUES SO THIS WILL BE OPEN TO ALL AND WILL THAT MEANS ESTABLISHING A NATIONAL NETWORK TO ALLOW ANYONE WHO WANTS TO JOIN THE STUDY, TO JOIN THE STUDY. THE CORE VALUE OF OUR PROGRAM IS DIVERSITY AROUND THE UNITED STATES. THAT OUR PARTICIPANTS ARE PARTNERS AND AS KATE MENTIONED, WE HAVE OUR PARTNERS TODAY AND ARE DEVOTED TO INCLUDING PARTICIPANT IN THE PROGRAM IN TERMS OF DEVELOPING AND DESIGNING THIS PROGRAM. THAT OUR TRUST WILL BE EARNED THROUGH TRANSPARENCY, THAT THE PARTICIPANTS HAVE ACCESS TO THEIR INFORMATION AND THAT IS REALLY GETTING AT RETURN OF VALUE OR RETURN OF INFORMATION DIRECTLY TO OUR PARTICIPANTS WHO JOIN THE STUDY, SO IT IS A BIDIRECTIONAL THING, THAT THE DATE TALL BE ACCESSED BROADLY FOR A WHOLE HOST OF PURPOSES AND WHEN WE SAY BROADLY, WE MEAN BROADLY AND IT IS NOT JUST FOR THE RESEARCHERS HELPING US BUILD THE PROGRAM. THAT SECURITY AND PRIVACY WILL BE OF HIGHEST IMPORTANT AND THE PROGRAM WILL BE A CATALYST FOR POSITIVE CHANGE IN RESEARCH AND I LOVE THIS ONE BECAUSE TO ME, IT GETS AT SOME OF THE STUFF WE'RE HERE TO TALK ABOUT TODAY, HOW CAN WE AS A COUNTRY CHANGE THE WAY WE DO RESEARCH FOR THE PARTICIPANT AND THEN FOR THE BETTER OUTCOME? SO CONGRESS BELIEVES IN WHAT WE'RE DOING AND IN FACT, AUTHORIZED THE PROGRAM FOR ABOUT $1.5 BILLION OVER TEN YEARS IN THE 21ST CENTURY CURES ACT ENACTED IN NOVEMBER 2016. THIS ACT ALSO GAVE US SOME REALLY IMPORTANT LANGUAGE AROUND PRIVACY AND DIVERSITY AND DATA SHARING AND IT HAS BEEN REALLY HELPFUL FOR US JUST TO ESTABLISH SOME OF THE CORE VALUES OF THE PROGRAM AROUND BEING BRADLEY OPENED AND MAKING SURE THAT THERE IS A LOT OF TRANSPARENCY AROUND WHAT FOLKS ARE DOING WITH THE RESOURCE. CONGRESS HAS BEEN INCREDIBLY SUPPORTIVE AND GAVE US OUR FIRST FUNDING IN FY16 AND WE HAVE HAD FUNDING SINCE THEN. I WANT TO GO BACK TO THE FINAL VALUE HERE AND I TALKED ABOUT CATALYZING A ROBUST ECOSYSTEM. SO WHEN WE WERE FUNDED BY CONGRESS AND WHEN WE FIRST ESTABLISHED THE BLUEPRINT OF THIS PROGRAM, IT REALLY IS ABOUT ESTABLISHING A PLATFORM THAT CAN ENABLE RESEARCH. YOU ARE PROGRAM IS NOT SITUATED TO FUND THE RESEARCH THAT HAPPENS ON THE TOP OF THIS PLATFORM, TO RESEARCHERS WHO WANT TO COME IN AND USE THE DATA TO RUN THEIR QUERIES. WE HAVE THE MONEY TO RUN THE CORE PROTOCOL, HOLD THE DATA SECURE AND MAKE IT AVAILABLE TO RESEARCHERS AND WHAT WE'RE TRYING TO DO IN COLLABORATION WITH ALL OF NIH AND THE EXTRAMURAL COMMUNITY AND WELL BEYOND THAT TO YOU ARE A MANDATE OF BEING OPEN AND INCLUSIVE IS TO UNDERSTAND WHAT WOULD BE THE MOST IMPORTANT TOOLS AND DATA TYPES FOR US TO BE ESTABLISHING IN THIS RESOURCE SO THAT IT IS USEFUL TO ENABLE SCIENCE ACROSS THE WHOLE HEALTH CONTINUUM. AND INCLUDING, IMPORTANT, ETHICAL, LEGAL AND SOCIAL IMPLICATIONS RESEARCH. SO THIS IS SORT OF HOW WE VIEW OUR PLATFORM. WE HAVE REALLY JUST BEGUN. WE CELEBRATED OUR FIRST ANNIVERSARY A MONTH AGO ON MAY 67TH AND ALL OF OUR PARTICIPANTS WHO HAVE JOINED THE STUDY ARE RIGHT NOW GOING TO OUR CORE PROTOCOL WHICH IS A CERTAIN SET OF DATA TYPES FROM PARTICIPANTS BUT WE DO VIEW THIS AS AN EVOLVING PLATFORM SO OVER TIME OVER THE COURSE OF THE STUDY, WE WILL BE ASKING PART TANS TO TELL US NEW THINGS ABOUT THEMSELVES, ASKING THEM TO TAKE PART IN SURVEYS, HEALTH AND TECHNOLOGY ACTIVITIES PERHAPS, RUNNING DIFFERENT ASSAYS ON THE BIOSPECIMENS THEY SHARE WITH US. SO FROM OUR PERSPECTIVE, THERE IS AN OPPORTUNITY, BECAUSE WE HAVE ESTABLISHED THIS DIGITAL PLATFORM AND HAVE A RELATIONSHIP WITH OUR PARTICIPANTS, WE CAN OVER TIME ASK THEM TO SHARE MORE TYPES OF DATA AND THAT IS IMPORTANT BECAUSE WE DIDN'T WANT TO LOCK DOWN JUST ONE PROTOCOL. WE WANT THIS TO EVOLVE WITH TECHNOLOGY AND SCIENTIFIC TECHNOLOGIES. SO THE INFLUENCE YOU ALL CAN GO HAVE HERE TODAY IN HELPING US DEVELOP STRONG USE CASES AROUND ELSI RESEARCH AND WHAT A DATA WE NEED TO ADVANCE THOSE FORWARD IS REALLY POWERFUL. WE DID THIS LAST MARCH WITH A VERY LARGE NATIONAL RESEARCH, CALLED THE RESEARCH PRIORITIES WORKSHOP AND WE DEVELOPED THIS -- WE PLANNED THE WORKSHOP WITH THE 27 INSTITUTE CENTERS FROM HERE AND ACROSS NIH AND THE SPECIFIC OFFICES WITHIN THE OT RESPONSIBLE FOR SCIENTIFIC PORTFOLIOS. WE ALSO HAD A WHOLE BREAKOUT SESSION AROUND ELSI ISSUES SO THIS JOYS WAS -- VOICE WAS PART OF THIS WORKSHOP AND WHAT EVERYBODY DID WAS COME TOGETHER FOR THREE DAYS AND HELPED THEM WITH THE USE QUESTIONS OF OUR DESIGN RESEARCH AREAS. IF YOU WANT TO ASK A QUESTION THIS BIG, WHAT TYPE OF RESEARCH WOULD YOU NEED TO ANSWER THAT QUESTION AND FROM THAT, WE GOT 514 USE CASES THAT WILL HELP US DEVELOP WHAT WE THINK WILL BE THE TYPES OF VARIABLES WE WILL BE COLLECTING ON PARTICIPANTS GOING FORWARD AND TODAY IS THE OPPORTUNITY TO DIG DOWN DEEPER ON THE ELSI SIDE AND Dr. KELLY WHO JUST JOINED US IN THE FALL WILL BE EXPLAINING THE FRAMEWORK AND THE OPPORTUNITIES TO CONTRIBUTE TO THAT. SOME OF THE QUESTIONS AND TYPES THAT CAME OUT OF THAT WORKSHOP LOOK LIKE THIS AND WE REALLY COMBED ACROSS ALL EXPERTS TO FIND THE DIFFERENT AREAS A OF SCIENCE. WHAT WE'RE HOPING TO DO TODAY BECAUSE WE HAVE A MORE CONCENTRATED AND FOCUSED TOPIC IS TO TAKE THAT AND FILL IT WITH QUESTIONS THAT ARE SPECIFIC TO THE COMMUNITY. SO COMING OUT OF THE WORKSHOP TODAY, BACK TO WHAT SHUBI WAS TALKING WITH, WE HAVE A FOCUSED SET OF TOPICS AND SO BEFORE I END, YOU WILL WALK THROUGH THE PROTOCOL AND THEN PASS YOU ON TO KELLY TO LOOK AT THE FRAMEWORK. WE JUST CELEBRATED AS MENTIONED OUR FIRST ANNIVERSARY ON MAY 6TH, OFFICIALLY OPENED OUR DOORS IN MAY 2018 WHEN R ALL FOLKS COULD JOIN THE PROGRAM, WHETHER DIGITALLY OR IN IT OUR HEALTHCARE ORGANIZATIONS. BEFORE THAT, WE HAD BEEN DOING A LOT OF BETA TESTING WITH OUR PARTICIPANTS. WE HAVE 209,000 PEOPLE WHO HAVE SIGNED UP FROM ACROSS THE COUNTRY. THAT MEANS THEY HAVE CONSENTED TO THE STUDY AND STARTING THE PROTOCOL AND OVER 161,000 OF THOSE PARTICIPANTS AS OF LAST WEEK HAVE FINISHED THE FULL VERSION 1 OF THE PROTOCOL AND I WILL WALK YOU THROUGH THIS AND THE DONATED SAMPLE. SO OUR NUMBERS ARE GOING UP. WE ARE HOPING TO REACH A MILLION OVER THE NEXT FEW YEARS AND IF WE CAN GO BEYOND A MILLION, WE CERTAINLY WOULD BE HAPPY TO DO SO. IN ADDITION TO THE NUMBERS WE'RE REALLY FOCUSING ON, AS I MENTIONED EVERYTHINGIER, -- MENTIONED EAR LIER, IS FOCUSING ON DIVERSITY. WE HAVE WHAT WE CALL UNDER REPRESENTED BIOMEDICAL RESEARCH, NINE CATEGORIES WE ARE TRACKING TO MAKE SURE WE HAVE PARTICIPANT REPRESENTATIVES IN THE PROGRAM FROM AREAS IN WHICH THEY HAVE ACTUALLY NOT BEEN INCLUDED IN THE PAST AND AMONG THOSE ARE RACIAL AND ETHNIC MINORITIES AND WE HAVE OVER 51 PERCENT OF OUR CURRENT PARTICIPANT POOL IN IT ETHNIC MINORITIES AND OVER 80 PERCENT IN AT LEAST ONE AREA OF UNDER REPRESENTED BIOMEDICAL RESEARCH SO THIS MEANS ET KNOW GENDER AND RACIAL CATEGORIES, WE WILL BE PUBLISHING A PAPER ON THIS IN THE NEAR TERM TO SEE HOW WE'RE TRACKING THIS AND WILL BE KEEPING A CLOSE EYE ON THESE NUMBERS. AND THAT IS BECAUSE AS WE ALL KNOW, THERE HAS NOT BEEN GREAT REPRESENTATION IN THE FIELDS THAT FOLKS ARE GETTING SCIENTIFIC KNOWLEDGE FROM SO OUR PRIORITIES ARE TO CHANGE THAT. IN ADDITION TO THAT, WE ARE ALSO REALLY FOCUSED ON ENABLING -- REALLY MAKING SURE THIS PLATFORM IS ABOUT ALL OF US SO INCLUDING PARTICIPANTS FROM EITHER PROTECTED OR SPECIAL POPULATIONS AND WE'RE WORKING ON PROTOCOLS TO ENROLL CHILDREN AND WILL START ENROLLING CHILDREN WHEN RED READY TO DO SO. WE ARE WORKING ON GETTING OUR PLATFORM ESTABLISHED, WORKING WITH THE ALASKA NATIVE POPULATIONS ON CONFRONTATIONS SO WE CAN GET TO AN GREED-UPON PLACE WHERE WE CAN WORK COLLABORATIVELY WITH THE AIA POPULATION AND THEN OVER TIME, WE WANT TO GET TO A PLACE WHERE WE HAVE THE POLICIES AND PROTECTIONS IN PLACE TO ENROLL INCARCERATED GROUPS AND FOLKS WITH OTHER BARRIERS SO MAKING SURE WE HAVE ALL THE RIGHT SUPPORT TO ENABLE ENROLLMENT ACROSS THESE PARTICIPANT GROUPS. WE HAVE OVER 358 SITES THAT ARE NOW ENROLLING PARTICIPANTS AND HERE IS A MAP SHOWING OUR LOCATION. AS I MENTIONED, PARTICIPANTS CAN ENROLL EITHER THROUGH A HEALTHCARE ORGANIZATION THAT WE ARE DIRECTLY PARTNERING WITH OR AS A DIRECT VOLUNTEER WHICH MEANS THEY ENROLL ON OUR WEBSITE, EITHER THROUGH THE SMART PHONE OR INTERNET AND THEY ARE ALL CLOSELY A GUARDED TO THE POINT WE NEED TO HAVE A PERSON COME IN AND DO THOSE ASPECTS OF PROTOCOL SO WE HAVE DEVELOPED PARTNERSHIPS WITH WALGREEN'S, THE NATIONAL BLOOD COLLABORATIVE AND WE HAVE ORGANIZATIONS THAT CAN GO TO PEOPLE'S HOMES TO DO PHLEBOTOMY IN THE HOUSE AND WE ARE WORKING THROUGH WHAT WE NEED TO ENABLE ANYONE ACROSS THE COUNTRY TO DO THE PROTOCOL SO WE WILL BE TESTING OUT THE SAMPLES, MAILING KITS TO HOMES AND TRYING TO FIGURE OUT WAYS TO REACH PARTICIPANTS ACROSS ALL CORNERS OF THE COUNTRY AND THEN ON OUR BIRTHDAY, WE LAUNCHED THE PUBLIC DATA BUROUGHSER AND YOU WILL HEAR MORE ABOUT THIS, THAT IT THIS ALLOWS ANYBODY THE ABILITY TO GO TO OUR WEBSITE TO SEE WHAT THE DEMOGRAPHICS LOOK LIKE AND THE DATA SHARED BY PARTICIPANTS INCLUDING THE TOP TEN POSITIONS WE ARE SEEING IN HEALTH RECORDS. SO LET ME WALK YOU THROUGH THE PROTOCOL SO YOU HAVE A SENSE OF WHAT OUR PARTICIPANTS JOINING THE LONGITUDINAL STUDY NOW ARE GOING THROUGH. AND AS I MENTIONED, YOU CAN JOIN ONLINE, WE HAVE HEALTH CENTERS ACROSS THE COUNTRY BUT WE CAN'T ACTUALLY COVER THE ENTIRE COUNTRY THROUGH THOSE PARTNERS SO THIS IS WHY WE ALLOW FOLKS TO SIGN UP ONLINE. AS I MENTIONED, THE ENTIRE PROTOCOL IS PHYSICAL OTHER THAN THE PHLEBOTOMY AND PHYSICAL MEASURES SO YOU CAN GO THROUGH IT THE E-CONSENT, WE ASK PEOPLE TO GO THROUGH OUR PRIMARY CONSENT ONLINE AND THEN ASK THEM TO SAY YES TO SHARING THEIR ELECTRONIC HEALTH RECORDS AND IF THEY SAY YES, WE INVITE THEM IN FOR A BIOSPECIMEN. THEN THEY ARE FILLING OUT THREE SURVEYS TO START AND THOSE ARE ON BASIC DEMOGRAPHICS, OVERALL HEALTH AND PERSONAL HABITS AND THEN SOME FEW MONTHS LATER, WE ASK THEM TO COME IN AND FILL OUT THREE KNEW SURVEYS. WE IMAGINE DEPLOYING A NUMBER OF SURVEYS OVER THE TIME OVER THE COURSE OF THE STUDY TO CAPTURE INFORMATION SELF-REPORTED FROM THE PARTICIPANTS. AFTER THAT, WE INVITE FOLKS TO COME IN IF THEY ARE ABLE TO, IF THEY LIVE CLOSE ENOUGH TO ONE OF OUR SITES AND FOR THOSE WHO ARE NOT, WE ARE WORKING ON METHODS TO GET TO EVERYBODY AND THE BLOOD AND TISSUE SAMPLES ARE SHIPPED OFF TO THE MAYO WHERE WE WILL RUN AS ASAYS ON THOSE AND WE WANT TO GET INTO THE DIGITAL APPS SO ONE OF THE QUESTIONS FOR THIS GROUP ARE WHAT ARE THE THINGS WE SHOULD BE ADDING TO THE PROTOCOL TO ENABLE THE TYPE OF RESEARCH THAT YOU THINK WOULD BE POWERFUL ENOUGH TO ENABLE AND THAT COULD INCLUDE DIGITAL HEALTH TECHNOLOGIES. CURRENTLY, WE HAVE A RELATIONSHIP WITH FITBIT AND ANYONE WHO HAS A FITBIT AND JOINS THE STUDY CAN SHARE THEIR DATA WITH US. THIS WILL BE REALLY INTERESTING TO SEE HOW THAT PHYSICAL ACTIVITY DATA IS USEFUL IN THE CONTEXT WITH THE REST OF OUR PROTOCOL. SO I MENTIONED GENOMICS. WE HAVE MADE ONE DECISION ABOUT ASSAYS ON GENOMICS AND WE WILL BE DO WHOLE HOST SEQUENCING OVER TIME, WE HAVE AN AWARD THAT WE WILL BE MAKING IN THE FALL SO WHEN WE START DOING THAT, WE CAN RETURN MEDICALLY ACTIONABLE RESULTS AND HOPING OVER TIME WE CAN OPEN UP MORE TYPES OF INFORMATION TO RETURN TO PEOPLE. YOU CAN IMAGINE ALREADY THERE IS A NUMBER OF ELSI QUESTIONS HERE AROUND THE RETURN OF INFORMATION AND WHAT PEOPLE DO WITH THAT SO ACROSS OUR ENTIRE PROGRAM, THERE ARE OPPORTUNITIES LIKE THIS. WE PLAN TO -- WE'RE HOPING TO START IN ANY END OF THE YEAR, BEGINNING OF NEXT YEAR, WORKING ON THE INFRASTRUCTURE, GETTING EVERYTHING UP TO SPEED. WE NEED TO GET OUR PROTOCOL APPROVED THROUGH THE FDA AND ARE WORKING ON OUR FIE SO THERE IS MUCH WORK TO BE DONE AND WILL BE MARTHA STEWART LAUNCHINGS IN THE VERY NEAR TURN. NOW, THAT COVERS OUR PROTOCOL BUT I MENTIONED INFORMATION AND WE HAVE SAID FROM THE BEGINNING OF THE PFLEGER ONE OF OUR CORE GOALS IS TO RETURN THE INFORMATION TO THE PEOPLE. THIS ISN'T THAT WE'RE DRAWING THE INFORMATION AND THEN GIVING NOTHING BACK SO THEY FEEL LIKE THERE IS A PRINCIPAL AND THEY GET TO SEE SOME INSIGHTS ON THEMSELVES AND THE COHORT BROADLY. WE HAVE CURRENTLY IN THE AMOUNT OF TIME ATLANTA WE HAVE BEEN UP AND RUNNING BEEN LOOKING FOR OPPORTUNITIES SHARE VALUE BACK WITH YOUR PARTICIPANTS AND COMING UP SOME OF THE OPPORTUNITY WE HAVE, WE WILL BE SENDING OUT A SLIDE TO CAPTURE BIOSPECIMENS FOR FOLKS WHO CAN'T GET INTEREST ONE OF OF OUR CENTERS WHERE WE CAN DO ANYBODY BOTTOM ME. -- PHLEBOTOMY. WE WILL BE SURVEYING MENTAL HEALTH ON OUR PARTICIPANTS, THERE WILL BE A MOOD MOT DUAL THAT FOLKS CAN INTERACT WITH DAILY AND SHARE THEIR MOOD. AND AT THE SAME TIME, WE'RE WORKING ON DEVELOPING LITTLE BITS OF INFORMATION WE CAN SHARE BACK WITH PARTICIPANTS THAT ARE JUST SORT OF MY MEDICAL MINUTES, THINGS GENERALLY USEFUL TO PARTICIPANTS AND EVEN INSIGHTS OF THEMSELVES SO WHEN YOU JOIN THE STUDY, WE CAN GIVE YOU INFORMATION ON HOW MANY PARTICIPANTS IN YOUR DEMOGRAPHIC ARE PART OF THE STUDY, OR IF YOU ARE A PART OF A CERTAIN AGE GROUP, WE CAN GIVE YOU HEALTH TIPS. SO LOOKING AT WAYS TO RETURN CENTRAL TO OUR PARTICIPANTS AND HOPE THIS WILL BE A GOOD OPPORTUNITY TO SEE HOW THAT CAN HELP WITH RETENTION LONG-TERM BECAUSE WE'RE WORKING ON THE LONGITUDINAL STUDY TO HAVE PEOPLE COME BACK AND SHARE INFORMATION WITH US AND THAT IS TRICKY IN A SUDDEN DEWHERE -- STUDY WHERE YOU ARE RELYING ON A DIGITAL PLATFORM. SO WITH THAT, I WILL WRAP UP, I WANT TO THANK YOU FOR SHARING YOUR TIME AND PERSPECTIVES WITH US TODAY. AS I MENTIONED AT THE BEGINNING OF MY TALK, WE ARE REALLY EXCITED WITH THE OPPORTUNITIES HERE, BOTH TO STUDY THE WAY THAT WE'RE RUNNING THE PROGRAM AND USE THE PLATFORM TO ENABLE ELSI RESEARCH. WE AS A PROGRAM WILL BE THE ONES DEVELOPING THE PLATFORM THAT WE HOPE FUNDERS FROM ACROSS NIH AND ACROSS THE COUNTRY WILL SUPPORT ELSI RESEARCHERS TO USE WITH THE DATA, BIOSPECIMENS AND PERHAPS RE-CONTACTING THE PARTICIPANTS AND TO ORDER A PROGRAM THAT IS ROBUST ENOUGH FOR THAT TYPE OF RESEARCH, WE NEED INPUT ALONG THE WAY FROM THE COMMUNITY ON WHAT TYPES OF INFORMATION WE SHOULD BE COLLECTING AND WHAT TOOLS WE SHOULD BE ENABLING DURING THE RESOURCE SO THANK YOU FOR COMING TOGETHER AND DOING THIS WITH US. IT SHOULD BE A FUN AND EXCITING TWO DAYS. [APPLAUSE] ALL RIGHT, PLEASE JOIN ME IN WELCOMING OUR NEW CHIEF SCIENCE MEDICAL OFFICER, Dr. KELLY GEBO. >> GOOD MORNING, THANKS FOR JOINING US TODAY AND I LOOK FORWARD TO SPENDING THE NEXT TWO DAYS WITH YOU TO SEE WHERE WE STAND IN TERMS OF THE SCIENTIFIC FRAME WORK. SO WHILE I GET THE PRIVILEGE LENGTH OF STANDING BEFORE YOU, THERE ARE MANY PEOPLE WHO HAVE BEEN DOING THIS WORK. THERE IS THE SCIENCE COMMITTEE OF ALL OF US RESEARCH PROGRAM, THERE ARE COCHAIRS OF VARIOUS DIFFERENT METHOD COMMITTEES WHO HAVE BEEN WORKING WITH US INCLUDING ASSAYS, DIGITAL TECHNOLOGY, AS WELL AS OUR COLLABORATORS WHO HAVE HELPED WITH THINKING THROUGH HOW WE SHOULD BE THINKING ABOUT OUR SCIENTIFIC FRAMEWORK AND WHAT I WOULD LIKE TO SHARE WITH YOU IS CURRENTLY WHERE WE STAND AND WHAT I WOULD LIKE TO GAIN FROM YOU THE NEXT TWO DAYS IS WHERE YOU THINK WE OUGHT TO HEAD. SO A COUPLE OF DISCLOSURES IN TERMS OF MY PREVIOUS FUNDING. WHAT I WOULD LIKE FOR YOU TO GAIN OUT OF THE NEXT 20 MINUTES IS THINKING WHAT THE MISSION OBJECTIVE AND SCIENTIFIC FRAMEWORK IS FOR THE PROGRAM, HITTING ON THE DATA AND THEN HELP US IDENTIFY WHAT SEE SEARCH QUESTIONS COULD SERVE AS AN ALL OF US DATA SOURCE THAT WILL BE USED BY RESEARCHERS LIKE YOU AND OTHERS THROUGHOUT THE WORLD ON WAYS TO IMPROVE HEALTH AND HEALTH OUTCOMES OF AMERICANS. SO MANY OF YOU HEARD ABOUT THE FRAMINGHAM HART STUDY DONE IN THE 1960S, ABOUT 5000 MEN AND IT EXTEND WITH THIS PROTOCOL, MANY OF THE THINGS WE TAKE JUST AS TRUTH IN HEART DISEASE BUT AT THE TIME, IT WAS REALLY NOT KNOWN THAT CIGARETTES INCREASED THE RISK OF HEART DISEASE, BLOOD PRESSURE, THAT EXERCISE REDUCED CARDIAC DISEASE, SO ALL OF THIS CAME OUT OF 5000 MEN IN FRAMINGHAM APPROXIMATELY 40 YEARS AGO. SO IF YOU THINK WHAT COULD HAPPEN, HE CARDIOVASCULAR DEATH RATE HAS GONE DOWN 25 PERCENT. THERE HAVE BEEN HUGE GAME CHANGERS WITH THE RESULTS OF THE STUDY AND IF YOU THINK ABOUT TAKING A MILLION AMERICANS, THE IMPACT COULD BE UNBELIEVABLE. SO WHAT I WOULD LIKE TO HIGHLIGHT HERE, ACCELERATE HEALTH RESEARCH AND MEDICAL BREAK THROUGHS, INDIVIDUALIZED TREATMENT AND PREVENTION FOR ALL OF US AND THE WAY THAT EACH RESEARCHER THINKS ABOUT THIS WILL BE VERY DIFFERENT. LIKE EACH PARTICIPANT WILL CONTRIBUTE INDIVIDUALIZED DATA, EACH RESEARCHER WILL HAVE AN SR*EUD SIZE SR*EUDS -- INDIVIDUALIZED WAY TO PARTICIPATE. SO WHILE RESEARCH OCCURS THAT OFTEN SO I WILL LOWS OR ACADEMIC SITUATIONS, WE'RE HOPING THIS WILL BE AVAILABLE GLOBALLY TO ALL KINDS OF INDUSTRY, PHARMA, GOVERNMENT AND CITIZEN SCIENCE AND HOPE WE ARE ABLE TO IMPROVE THE WAY WE DELIVERY SEARCH AND THE OUTCOMES OF THAT THROUGH THE PLATFORM AS WELL AS THE INDIVIDUALIZED RESEARCH THAT WE PARTAKE. THIS IS SUPPORTED BY THE GENOMIC STUDIES. OF 1.7 MILLION SAMPLES, 96 PERCENT WERE FROM PEOPLE WITH EUROPEAN ETHNICITY. THE OVERALL MAJORITY, OVER 81 PERCENT AFTER WE LEEK D AT THIS, -- LOOKED AT THIS, AND IT WAS CLEAR WE NEEDED GREATER BIODIVERSITY NOT ONLY FOR BLOOD STUDY BUT OTHER ASPECTS OF THE RESEARCH. THERE ARE A LOT OF THINGS IN THE PROGRAM, ONE THAT ATTRACTED ME TO WAS THE DIVERSITY OF SCALE. I HAD DONE RESEARCH PRIOR TO COMING TO THE NIH PROGRAM AND DEALT WITH A DISENFRANCHISED POPULATION SO TO BE ABLE TO STUDY THIS GROUP IS REALLY WHAT ATTRACTED ME TO THIS GROUP. THE OTHER THING THAT IS GREAT WITH THIS IS IT IS LONGITUDINAL SO WE WILL BE ABLE TO CONNECT WITH PEOPLE, PROVIDING WIDE VARIETY OF DATA AND FOCUSING ON OUR PARTNERS. UNLIKE MANY STUDIES WHERE PARTICIPANTS DONATE THEIR DATA, WE'RE VIEWING PARTICIPANTS AS PARTNERS AND EQUAL TO HELP US THROUGH THE SCIENCE, WHAT ARE THE QUESTIONS WE SHOULD ASK AND THE WAYS WE SHOULD ASK THESE QUESTIONS AND IT WILL BE AN OPEN NATIONAL RESEARCH BY ALL. SO WE TALK ABOUT DIVERSITY, THANK YOU TO ALL OF YOU PARTNERS HERE TODAY. THERE ARE OTHER PARTNERS WHO HAVE HELPED US THINK ABOUT THE DATA WE WANT TO COLLECT, LAB ANALYSIS AND RETURN OF THE RESULTS YOU WANT TO GET AND WHAT TYPE OF RESEARCH SHOULD BE CONDUCTED. THEN WE PARTNERED WITH A LOT OF LOCAL AND COMMUNITY GROUPS WHO HAVE HELPED US AS WELL AS NATIONAL GROUPS IN HELPING US RECRUIT PARTICIPANTS AND HELPING US THINK THROUGH WHAT ARE THE WAYS WE CAN BE VIEWED AS PARTNERS. SO I WANT TO TALK A LITTLE BIT ABOUT THE SCIENTIFIC FRAMEWORK AND THESE WERE FIVE PRINCIPLES THAT HAVE COME UP AND BEN GENERATED ON BEHALF OF THE PROGRAM AND AS STEPH WAS HIGHLIGHTING, WE WILL BE REALLY ENABLING RESEARCH. WE WILL NOT BE DOING THE RESEARCH OURSELVES, YOU AND OTHERS AROUND THE GLOBE WILL HOPE TO FACILITATE USING THIS RESEARCH PLATFORM TO MAKE NEW DISCOVERIES AND THE THINGS WE WANT TO FOCUS ON IS INCREASING HEALTH RESILIENCE AND AWARENESS, HEALTH ASSESS P.M. AND PREVENTION STRATEGIES, MORE ACCURATE DIAGNOSES AND IMPROVING HEALTH OUTCOMES AND DISEASE THROUGH DEVELOPMENT INITIATIVES. SO THESE FIVE PRINCIPLES ARE WHAT WE'RE USING TO GUIDE WHAT ARE THE DATA WE WANT TO COLLECT AND THE METHODOLOGIES WE WANT TO USE TO COLLECT THAT DATA. SO WE HAVE CONTACTED A NUMBER OF OUR INSTITUTE PARTNERS IN THINKING THROUGH HOW WOULD THEY USE THIS FRAMEWORK FOR ENABLING RESEARCH WITHIN THEIR SPECIFIC DISEASE CATEGORIES. SO WE TALKED TO NIHLBI AND THEY HAD US LOOKING AT HOW WE WOULD VIEW BLOOD PRESSURE THROUGH THESE FIVE AREAS AND AS YOU CAN SEE, THEY ARE EXTRAORDINARILY FOCUSED ON BLOOD PRESSURE AND CARDIOVASCULAR DISEASE. WE THEN FOCUSSED ON RESILIENCE SO WE TALKED TO SOME OF OUR COLLEAGUES AT THE NATIONAL NURSING RESEARCH ACROSS NIH AND THEY HELPED US COME UP WITH FIVE QUESTIONS IN THINKING OF RESILIENCE, HEALTH EQUITY, NEGATIVE HEALTH OUTCOMES, HOW THEY MANIFEST DIFFERENT IN DIFFERENT SUBPOPULATION, RISK, TREATMENT, A WHITE VARIED OF WAYS AND THE SAME FRAMEWORK COULD BE USED IN DIFFERENT DISEASE CATEGORIES. AND THEN FINALLY WELLNESS WHICH IS ONE OF THE MOST IMPORTANT PRINCIPLES OF OUR STUDY AND WE HAVE TALKED WITH OTHERS AT NI H HELPING US COME UP WITH QUESTIONS OF HOW COULD WELLNESS BE WORKED BUILT IS FRAMEWORK AND AGAIN, THE SAME FIVE PRINCIPLES, ALL WITH WELLNESS BEING THE SPECIFIC FOCUSES. WE HAVE DEVELOPED A WHOLE SERIES OF THESE TYPES OF QUESTIONS FOR THINKING ABOUT ASTHMA, CHRONIC LOUNGE -- LUNG DISEASE AND OTHERS AND HOW TO USE ELSI TO THINK ABOUT THIS. SO WE CANNOT COLLECT EVERY VARIABLE ON EVERY DISEASE THROUGH THE FIRST ROUND OF THE PROTOCOL SO WHAT ARE SOME OF THE WAYS WE COULD FOCUS OUR DATA COLLECTION EFFORTS? AND WE LOOKED AT WHAT WERE THE TOP CAUSES OF DEATH IN THE CDC, WHAT WERE THE DALY'S OR DISEASE ADJUSTED LIFE YEARS AND DISPARITIES AND ARE WE TRIED TO PUT THESE TOGETHER. WE HAVE THE BLUE, THE RED THINKING MORE ABOUT MORBIDITY AND WHAT WERE THE MAJOR AREAS OF DISPARITIES AND WE FOUND AN OVERLAP SO CANCER, DIABETES, KIDNEY AND LUNG DISEASE AND CARDIOVASCULAR DISEASE WERE FOUND IN ALL THREE OF THESE STUDIES. SO WE NOW HAVE DEVELOPED WHAT WE CALL THE BIG EIGHT CATEGORIES THAT WE'RE FOCUSING ON RIGHT NOW FOR THE PURPOSES OF THIS PROTOCOL. CANCER, CHRONIC LUNG AND KIDNEY DISEASE, OBESITY, DIABETES, PAIN AND WELLNESS. SO WE ARE TRYING TO THINK OF THE CURRENT PARTICIPANT JOURNEY AND STEPH HIGHLIGHTED A LOT OF THIS REGARDING THE DATA. WE'RE DOING IT DIGITALLY AND TRYING TO MINIMIZE THE AMOUNT WE ASK PARTICIPANTS TO TO INDIVIDUALLY. SO WE HAVE SIX OF THOSE ONGOING AND ADDITIONAL SURVEYS WE WILL BE CONDUCTING IN THE FUTURE BUT THROUGH OUR ELECTRONIC HEALTH RECORDS AND SOME OF THESE OTHER METHODS, WE'RE TRYING TO REDUCE THE NEEDS OF PARTICIPANTS ON A SEMI ANNUAL OR BIENNUAL BASIS. WE EXPECT THEY WILL COME IN ALTERNATE BASELINE AND THEN THREE YEARS AFTER, THAT WE ARE STILL WORKING THROUGH WHAT THE REASSESSMENTS LOOK LIKE BUT CURRENTLY THEY HAVE THESE CHARACTERISTICS AND OUR PARTICIPANTS ARE PROVIDING BIOSAMPLES, BLOOD AND SOUTHERN WHEN URINE AND IF NOT POSSIBLE, THEN SALIVA. PARTICIPANTS WILL BE DONATING THEIR DATA IN A WAY THAT MINIMIZES THE PARTICIPANT BURDEN. SO IF YOU ENROLLED IN THE ALL OF US RESEARCH STUDY TODAY, WHAT WOULD BE THE ASSESSMENT AND WHEN WOULD YOU DO THEM? SO IF THIS IS TIME ZERO IN ROLLING TODAY, WE WOULD ASK YOU TO DO THE PPI MODULES, YOU WOULD COME IN FOR THE BIOSPECIMENS AND PHYSICAL MEASUREMENTS, AND YOU CAN DONATE YOUR FIT BIT DATA IF YOU HAVE A FITBIT. THEN AFTER THE FIRST 30 DAYS, YOU GET FURTHER INFORMATION. GINO TYPING WILL GENE GENOTYPING WILL BE ROLLED OUT LATER THIS YEAR. EVENTUALLY IN THE FUTURE, AS STEPH WAS SUGGESTING, WE WILL HAVE ADDITIONAL MODULES, SURVEYS TO BE ROLLED OUT, REAFFIRM THE BASICS MODULES YOU DID AT THE ENTRY WHEN YOU STARTED THE STUDY AND THEN WE ANTICIPATE WE WILL COLLECT NEW VARIABLES AS WE MOVE FORWARD WITH THE STUDY OVER THE NEXT TEN YEARS. YOU WILL BE GETTING A LOT OF INFORMATION ON THE RESEARCH DATA HUB BUT THIS IS HOW RESEARCHERS ACCESS THE PLATFORM TO BE ABLE TO UTILIZE IT. RIGHT NOW WE HAVE OUR PUBLIC BROWSER THAT IS AVAILABLE. I WOULD ENCOURAGE THOSE OF YOU WHO HAVEN'T SEEN THAT TO LOG IN, YOU CAN SEE THOSE ENROLLED AS WELL AS LOOK AT THE MEDICATIONS, PROCEDURES THAT OCCURRED THROUGH THE ELECTRONIC HEALTH RECORDS IN OUR PARTICIPANTS. IN THE WINTER 2,062,019-20, WE EXPECT THE WORK BENCH -- THE WINTER OF 2019-20, YOU WILL BE ABLE TO SEE THESE ITEMS AND THERE WILL BE A LOT MORE TALKED ABOUT BY THE HELP DESK LATER THIS MORNING. THIS WILL BE AVAILABLE TO ALL USERS USING A CLOUD-BASED ANALYSIS PLATFORM SO EVERYONE WILL BE ABLE TO DO IT INSTEAD OF DOWNLOADING THIS TO YOUR OWN SYSTEM. THERE WILL BE DATA MORE CONFIDENTIAL THAN OTHERS AND YOU WILL HAVE TO GAIN INFORMATION TO USE IT. THE INFORMATION WILL BE MADE PUBLIC AND IT IS AUDIBLE SO THAT ANYBODY WHO DOES RESEARCH HERE WILL LEAVE A IMPORTANT AND YOU WILL BE ABLE TO USE THAT WHEN YOU SUBMIT THAT TO A JOURNAL TO SAY HERE IS HUEY DID THE RESEARCH SO OTHERS CAN USE IT AND IF THERE IS AN ERROR, YOU CAN GO BACK TO A RESEARCH TRACING IN CASE ANYTHING IS DONE. AND THEN THERE ARE SAMPLES TO THE COHORT. SO WE HAVE HAD A LOT OF STEPS IN TERMS OF GETTING TO THE PROTOCOL ROADMAP. WE HAVE WORKED WITH VARIOUS SCIENCE COMMITTEES TO DETERMINE CORE VARIABLES, WORKED THROUGH ALL THE DIFFERENT DATA TYPES AND THEN WORKED THROUGH THE PROTOCOL WITH THE STEPS. WE IDENTIFIED THE EIGHT CORE AREAS SO BRINGING TOGETHER THE CASES FROM THE RESEARCH PRIORITY WORKSHOP AND WHAT WERE THE VARIABLES THAT NEEDED TO BE DONE FROM THESE EIGHT CORE AREAS. WE STARTED TO COME TOGETHER TO BUILD A PROTOCOL LIST. SO WE HAVE A NUMBER OF VARIABLES UNDER CONSIDERATION AND WE HAVE GUIDING PRINCIPLES FOR SELECTING THESE PRINCIPLES AND WHAT ARE THE METHODS THAT WILL BE DONE TO DO SO. SO WE AGAIN, TALKING ABOUT BEING ABLE TO MINIMIZE THE BURDEN WITH OUR PARTICIPANTS, AND THE MESSAGE CHOSEN WILL BE PARSIMONIOUS. IF WE CAN DO SOME OF THESE THINGS DIGITALLY, WE WOULD LIKE TO DO THAT. THE METHODS CHOSEN WILL COME FROM AS MANY PARTICIPANTS AS POSSIBLE. WE WOULD LIKE TO GET A MILLION PARTICIPANTS BUT THAT WILL NOT HAPPEN SO WE ARE TRYING TO MAXIMIZE THE NUMBER WE WILL GET AND THEN IF WE CAN'T GET A DATA TYPE FROM A SUBSET OF OUR PARTICIPANTS FOR A VARIETY OF REASONS, FOR EXAMPLE, WE DON'T HAVE COMPLETE ELECTRONIC RECORDS FROM SOME OF THEM BECAUSE THEY DON'T HAVE ACCESS TO HEALTHCARE, HOW SHOULD WE ACCESS THAT DATA, WHAT ARE THE WAYS WE CAN COLLECT THE MOST COMPREHENSIVE DATA ON THE MOST NUMBER OF PEOPLE. AND THEN THE OTHER THING WE'RE THINKING ABOUT IS DISCUSSING THE HETEROGENEITY AND THE QUALITY OF DATA FROM DIFFERENT POPULATIONS. WE WANT TO MAKE SURE WE'RE MISSING AT RANDOM SO IF THERE ARE GROUPS MISSING MORE THAN OTHERS, THAT WE GO OUT AND SOLICIT THAT DATA SO WE CAN GET AS COMPREHENSIVE A DATA SET AS POSSIBLE. SO THIS IS THINKING ABOUT OUR DATA AND I THINK THE VARIABLE LISTS ARE ACTUALLY IN YOUR FOLDER. WHAT WE HAVE IDENTIFIED OR WHAT ARE THE OUTCOMES. SO KIDNEY DISEASE IS ONE OF THE OUTCOMES AND WHAT IS THE DECISION OF KIDNEY DISEASE AND THAT IS FILLED OUT THROUGH SURVEY INFORMATION. AND WHAT WE ARE ALSO THINKING ABOUT IS SOME OF THE OTHER VARIABLES. THESE ARE ALL THINGS WE THINK WE CAN OBTAIN IN THE NEAR TERM THROUGH THE ELECTRONIC HEALTH RECORD BUT WHAT ARE SOME WAYS WE COULD DO THIS IN THE MIDDLE AND LONG-TERM? WE THINK IF WE LINK THE DATA SYSTEMS, WE CAN IDENTIFY MORE SYSTEMS OR LINK MORE ACROSS THE DATA SYSTEM TO COLLECT MORE COMPREHENSIVE DATA AND MINIMIZING OUR MISSING DATA. NOW, PARATHYROID DISEASE IS COMMON WITH PEOPLE WHO HAVE KIDNEY DISEASE AND WE WANT TO SEE THIS IN OUR ASSAYS. THIS IS FAIRLY HIGH-LEVEL DATA. IT DOESN'T GIVE US A LOT OF SPECIFICS IN TERMS OF WHAT WERE THE CANCER TYPE, THE GENOMICS OF THE CANCER, THE TREATMENTS ENGAGED IN? SO WE'RE THINKING DIAGNOSIS WITH CANCER COULD BE OBTAINED THROUGH THE EHR AND EVENTUALLY PPI. THE DIAGNOSES OF PRECANCEROUS CONDITIONS TO BE DONE THROUGH EHR AND THEN WHAT ARE THE ADDITIONAL LINKAGES WE CAN OBTAIN? MANY OF YOU HEARD OF THE SIERRA DATABASE WHERE WE CAN LINK UP OUR INFORMATION AND THIS WILL REDUCE THE MISSING DATA WE HAVE AND INCREASE THE DATA WE HAVE TO OUR RESEARCHERS? A. SO OUR PROPOSED VARIABLISTS ARE IN BLUE. BLACK ONES ARE WHAT ARE BEING CONSIDERED AND THE LIST THAT WE HAVE ARE ORGANIZED BY OUTCOME, SOCIOEDEMIC EXPOSURE AND THIS IS NOT FINAL. YES? OKAY SO -- [ OFF MIC ] >> THEY ARE COMING. BUT WE'RE SEEKING YOUR FEEDBACK AND WHILE -- YES, ACTUALLY, I HAVE THE EIGHT OUTCOMES. SO IT STARTS AT THE TOP WITH OUTCOMES STARTING WITH GENERAL OUTCOMES WHICH ARE OVERALL. DEATH IS OBVIOUSLY THE BIGGEST ONE AND WE WILL HAVE CAUSE OF DEATH AS WELL AS DATE, HOSPITALIZATION FOR ANY CAUSE, ORGAN TRANSPLANT WHICH, AGAIN, GOES ACROSS MULTIPLE DISEASE CATEGORIES SUCH AS KIDNEY DISEASE, CARDIOVASCULAR DISEASE, ET CETERA AND THEN OUTCOMES LISTED FOR EACH OF THOSE EIGHT HEALTH CONDITIONS. AFTER THAT, IT WILL BE LISTED BY SOCIODEMO GRAPH DEMOGRAPHIC FEATURES THAT APPLY TO ALL AGES, SEX AT BIRTH, GENDER IDENTITY, SEXUAL ORIENTATION, ALCOHOL, DRUG USE, SOCIAL DETERMINANTS OF HEALTH WHERE, DO PEOPLE LIVE, WHAT THE THE SOCIOECONOMIC STATUS, RISK FACTORS TO EXPOSURES, BEYOND TOBACCO, THINKING OF ARSENIC OR OTHER HEAVY METALS. LAB TESTS, SOME OF THE DIFFERENT ASSAYS WE'RE THINKING ABOUT AND THE OMICS, ALL OF THESE ON THE FORE CONSIDERATION. THE LIST IS NOT FINAL AND WE ARE SEEKING FEEDBACK SO WE WILL WELCOME YOUR INPUT ON THAT. IF THERE ARE ANY, E-MAIL IT TO ME, I WOULD BE HAPPY TO SEE THAT BUT WHAT I WANT YOU TO HELP US THINK THROUGH IS TRYING TO MAXIMIZE THE DATA TYPES OF A MILLION PEOPLE. SO WE WANT TO OBTAIN COMPLETE DATA SETS ON A MILLION PEOPLE AND FOR THINGS WE CAN'T COLLECT ON EVERYONE, FOR EXAMPLE, HEALTH RECORDS, HOW CAN WE GET THAT IN OTHER WAYS. SHOULD WE HOLD OFF ON ASSAYS AND TRY TO GET AS MUCH INFORMATION FROM HEALTH RECORDS AS THEY WILL HELP US MAXIMIZE THE BLOOD AND BIOSAMPLES. THIS WILL ALLOW US TO HAVE MORE BLOOD AND ASSAY MONEY AVAILABLE TO DO INNOVATIVE STUDIES MOVING FORWARD. SO WHAT I KNOW YOU GUYS WILL BE FOLKED ON IN THE NEXT FEW DAYS ARE THINKING ABOUT WHAT ARE THE ELSI VARIABLES AND QUESTIONS WE NEED TO INCORPORATE IN THE PLATFORM AND WHAT SHOULD BE THE NEXT QUESTIONS TO THINK THROUGH. I KNOW THIS IS ALL PART OF YOUR NEXT TWO DAYS AND YOUR CASE GENERATION AND WE LOOK FORWARD TO SEEING WHAT THE WORKSHOP GENERATES. I AM REALLY HOPING TO PART AND SEE SOME OF THIS LIVE BUT ALSO LOOK FORWARD TO THE WHITE PAPER AND SUMMARY DOCUMENT THAT ARE PUT TOGETHER. I KNOW OUR SCIENCE COMMITTEE IS EXCITED ABOUT THIS AND LOOKING FORWARD TO WORKING WITH ALL OF YOU ON THIS. WE HAVE A LOT OF WORK TO GO. WE HOPE TO BE INCORPORATING WHAT YOU ARE DOING AND OVER THE FALL, THE NEXT WORKSHOP BUT WE HAVE ACCOMPLISHED A LOT IN THE LAST TWO AND A HALF YEARS AND EXCITED ABOUT WHAT THE FUTURE IS AND LOOKING TO HAVING MORE DISCOVERY IMPACT IN 2019 AND BEYOND. SO I REALLY WANT TO THANK ALL MEMBERS OF OUR CONSORTIUM WHO HELP US GETTING THE DATA, ALL OF OUR PARTNERS WHO ARE THOUGHTFUL IN ENGAGING OUR PARTICIPANTS AND WHILE I HAVE THE PRIVILEGE OF STANDING HERE BEFORE YOU, THERE ARE MANY, MANY PEOPLE BEHIND THE SCENES WORKING ON THIS, SOME OF WHICH ARE IN THIS PHOTO AND IT REALLY DOES TAKE ALL OF US TO LAUNCH THIS. SO I APPRECIATE YOU BEING HERE, HAPPY TO ENTERTAIN QUESTIONS, KATE IF YOU WANT TO HAVE CONSUELO GO FIRST OR ENTERTAIN QUESTIONS NOW -- [ OFF MIC ] >> PERFECT, THANK YOU AGAIN FOR YOUR TIME. [APPLAUSE] >> I WOULD LIKE TO INTRODUCE CONSUELO WILKINS, THE VP OF HEALTH AT VANDERBILT UNIVERSITY MEDICAL CENTER AS WELL AS A MEMBER OF THE ALLIANCE, AMAZING JOB IN HELPING US US WITH THE RESEARCH PROGRAM AS WELL SO PLEASE JOIN ME IN WELCOMING HER. >> I HAVE A GLITCH HERE TO FIX AND I WILL NOT BE ASKING YOU FOR INFORMATION MISSING I DON'T YOU ARE FOLDERS. IT IS REALLY A PLEASURE FOR ME TO TALK TO YOU ABOUT SOME OF THE ENGAGEMENT PRIORITIES FOR ALL OF US. I CAN'T TELL YOU HOW REALLY INCREDIBLE IT IS TO SEE AND BE INVOLVED IN A RESEARCH PROGRAM WHERE I AM NOT THE ONLY ONE TALKING ABOUT ENGAGEMENT. SO THE DEPUTY DIRECTOR, THE SCIENCE DIRECTOR, ALL TALKED ABOUT PARTICIPANTS AND PARTNERS, BOTH TALKED ABOUT ENGAGEMENT AND FOR THOSE OF US WHO HAVE BEEN DOING COMMUNITY ENGAGEMENT FOR A LONG TIME, THAT IS REALLY WHERE WE'RE AND YOU ISOLATED AND CONSTANTLY HAVING TO SAY THAT AS THE ONLY PEOPLE IN THE ROOM. SO THIS IS REALLY A UNIQUE OPPORTUNITY FOR ME AND OTHERS WHO REALLY THINK THIS IS SO IMPORTANT. WHAT I WOULD LIKE TO SHARE WITH YOU THIS MORNING, HOPEFULLY, ARE THREE MAIN POINTS. ONE IS THAT THE ALL OF US PROGRAM HAS A VERY COMPREHENSIVE APPROACH TO ENGAGING PARTICIPANT, COMMUNITIES, PROVIDERS AND OTHER STAKEHOLDERS. I WANT TO REMEMBER THAT ENGAGEMENT IS NOT RECRUITMENT AND RETENTION. IT IS NOT RECRUITMENT AND RETENTION. THAT IS PROBABLY ONE OF THE BIGGEST CHALLENGES WE FACE, ESPECIALLY WITH TALKING TO SCIENTISTS WHO HAVE NOT -- WHO HAVE BEEN SOMEWHAT REMOVED FROM THE ACTUAL ENGAGEMENT PROCESS. THESE ARE VERY DIFFERENT THINGS AND ENGAGING PARTICIPANTS AS PARTNERS, WE THINK IT WILL ACTUALLY ENHANCE THE SCIENCE, MAKE IT MORE RELEVANT AND EVETUALLY INCREASE THE CHANCES THAT DISCOVERIES WILL ACTUALLY BE PUT INTO PRACTICE. SO STEPH INTRODUCED THE CORE VALUES OF THE PROGRAM AND WE THINK THAT THESE ACTUALLY MANDATE ENGAGEMENT. SO IF WE'RE GOING TO TALK ABOUT PARTICIPATION BEING OPEN AND THE DIVERSITY AND HAVING CITIZENS AS PARTNERS, THEIR TRUST IS IMPORTANT AND TRANSPARENCY, ALL OF THESE THINGS REALLY REQUIRE THAT WE'RE ENGAGING POPULATIONS, COMMUNITIES, INDIVIDUALS, IN IT ALL ASPECTS OF THE PROGRAM. SO I THINK THAT IS AGAIN WHY YOU SEE OR HEAR THIS BEING SAID BY SO MANY OTHERS IN THE PROGRAM. THE CHIEF ENGAGEMENT OFFICER FOR ALL OF US HAS QUITE A LARGE PORTFOLIO OF ENGAGEMENT ACTIVITIES. THESE INCLUDE ENGAGEMENT PARTNERS OUTSIDE THE CONSORTIUM SO NOT INVOLVED IN THE DAY-TO-DAY WORK OF THE CONSORTIUM BUT TRUSTED NATIONAL AND REGIONAL PARTNERS, COMMUNITY, HEALTHCARE, ADVOCACY ORGANIZATIONS RESPONSIBLE FOR HELPING TO INCREASE AWARENESS OF THE PROGRAM, SOME ARE HELPING TO EDUCATE PROVIDERS AND THEN THERE ARE ALSO CHAMPIONS WHO ARE ALSO NATIONAL AND REGIONAL ORGANIZATIONS WHO HAVE COMMITTED TO HELPING THE ALL OF US RESEARCH PROGRAM ACHIEVE ITS GOAL. AND THIS PICTURE HERE I STOLE FROM ANOTHER PRESENTATION BUT A FACE-TO-FACE MEETING OF THE COMMUNITY PARTNERS BACK IN MAY AND YOU CAN REALLY SEE THE DIVERSITY OF THE REPRESENTATION HERE IN THAT GROUP. YOU HAVE SEEN THIS A COUPLE OF TIMES ALREADY. AGAIN, I WANT TO EMPHASIZE REALLY THE RANGE AND TYPES OF ORGANIZATIONS WE'RE TALKING ABOUT -- BLACK, FRATERNITIES AND SORE REPORTS, HEALTH ADVOCACY THROUGH, YOU KNOW, REALLY LARGE GROUPS LIKE AMA, BUT ALSO SMALLER GROUPS WHO HAVE NOT REALLY BEEN AT THE TABLE WHEN WE'RE TALKING ABOUT HEALTH, WELLNESS AND CLINICAL RESEARCH. SO AGAIN, A VERY DIVERSE GROUP OF PEOPLE. SO IMPORTANT THAT WE HAVE THESE OPPORTUNITIES TO ENGAGE THEM. THERE ARE ALSO KEY ENGAGEMENT PARTNERS AT THE CONSORTIUM TABLE ON A DAY-TO-DAY BASIS SO I MENTIONED HCM STRATEGIES LED BY RONNIE TEPP AND THEY ARE INVOLVED WITH WORKING WITH ACHMED AND VARIOUS OTHER TEAMS TO ENGAGE THAT LARGE GROUP OF NATIONAL AND REGIONAL PARTNERS. THERE ARE FOUR ORGANIZATIONS THAT KEY PARTNERS HAVE AWARDS FROM NI H AND ACTUALLY SEATS ON THE STEERING COMMITTEE SO THAT IS THE DELTA RESEARCH AND EDUCATIONAL FOUNDATION, 50 FORWARD WHICH IS AN OLDER ADVOCACY ORGANIZATION, NATIONAL ALLIANCE FOR HISPANIC HEALTH AND PRIDE NET WHICH WAS FORMERLY AT SAN FRANCISCO GENERAL HOSPITAL AND NOW HAS MOVED TO STANFORD AND THEY FOCUS ON ENGAGING SEXUAL ENGENDERED MINORITIES. EACH OF THEM HAS AN ENGAGEMENT TEAM. THERE ARE DOLLARS DEDICATED TO ENGAGEMENT, NOT JUST RECRUITMENT AND THOSE SITES AND VARIOUS TEAMS WORK CLOSELY WITH THOSE ENGAGEMENT LEADS. AND I WILL TELL YOU A LITTLE MORE ABOUT OUR CORE, NOT JUST AT VANDERBILT OR LED BY VANDERBILT. SO IT IS IMPORTANT TO REALLY DISTINGUISH BETWEEN THESE CONCEPTS BECAUS IF YOUR ONLY GOAL IS INTERACTING WITH PEOPLE IS TO GET THEM TO THE STUDY, THAT IS NOT ENGAGEMENT, THAT IS RECRUITMENT. IF YOU ARE LOOKING TO REALLY GET THE VOICES OF STAKEHOLDERS AND PARTICIPANTS IN THE COMMUNITY DESIGN, CONDUCTING THE STUDY, DISSEMINATING, SHARING THE RESULTS, COMPLETELYING THE CIRCLE, COME -- COMPLETING THE CIRCLE, THAT IS THE GOAL OF ENGAGEMENT SO WE TRY TO WORK CLOSELY TO DISTINGUISH THESE THINGS BECAUSE AT THE END, EVEN THOUGH THE GOAL OF ENGAGEMENT IS NOT RECRUITMENT, IF YOU DO ENGAGEMENT WELL, IT OFTEN ENHANCES YOUR RECRUITMENT AND RETENTION SO I THINK THAT IS PART OF THE CHALLENGE THERE. I KNOW SOME OF YOU IN THE ROOM ARE AWARE I LEAD A NATIONAL RECRUITMENT CENTER ALONG WITH PAUL HARRIS SO WE THINK A LOT ABOUT OF RECRUITMENT CONTINUUM AND I AM ALWAYS, BECAUSE I COME FROM AN ENGAGEMENT LENS, I AM ALWAYS THINKING ABOUT HOW TO MAKE SURE WE ARE STILL ENGAGING AT EVERY STEP ALONG THIS RECRUITMENT CONTINUUM. SO I SHARED WITH YOU ALREADY THERE ARE NATIONAL AND REGIONAL PARTNERS WHO HAVE FOCUSED ON HELPING WITH THE AWARENESS. SO AWARENESS IS THE FIRST STEP FOR RECRUITMENT. THERE ARE PEOPLE WHO ARE NOT TRADITIONALLY REPRESENTED IN RESEARCH, WHO THIS IS A NEW PROJECT FOR THEM, WE HAVE TO NOT ONLY MAKE THEM AWARE OF OF THIS RESEARCH STUDY, THIS PROJECT, BUT ALSO ABOUT RESEARCH, AND SO SOME OF WHAT YOU MIGHT HEAR FROM OUR COMMUNITY PARTNERS IS A PROCESS OF CLINICAL RESEARCH LITERACY AND MAKING SURE THAT THEY UNDERSTAND WHAT THEY ARE COMMITTING TO AND SO THAT IS AN IMPORTANT PIECE. AWARENESS OF COURSE DOES NOT MEAN ACCEPTANCE. ACCEPTANCE, THE KEY PIECES THERE, ESPECIALLY FOR POPULATIONS THAT HAVE BEEN MARGINALIZED OR DISENFRANCHISED OR HISTORICALLY ABUSED IS THAT THEY MAY BE AWARE, THEY MAY FULLY UNDERSTAND, GO BUT NOT TRUST OR BE WILLING TO COMMIT TO THE PROGRAM. SO THERE IS ENGAGEMENT THAT IS REQUIRED IN ORDER TO GET PAST THAT STEP AND THEN OF COURSE THE OTHER ASPECTS THERE ARE MORE TRADITIONAL, CONSENTING, ENROLLING. RETENTION IS REALLY GOING TO BE BE IMPORTANT. WE'RE TALKING ABOUT A STUDY WHERE WE HOPE PEOPLE WILL BE ACTIVELY INVOLVED FOR AT LEAST TEN YEARS. HOW WILL WE DO THAT? ESPECIALLY IF THE PROGRAM IS SHIFTING -- IT MAY START -- PEOPLE MAY ENROLL IN PERSON BUT A LOT OF THE OTHER ASPECTS HAVE TO OCCUR ONLINE OR DIGITALLY. HOW DO WE MAKE SURE WE'RE ENGAGED? SO THIS WILL BE SOMETHING THAT EVERYONE IN THE CONSORTIUM IS WORKING ON, IT IS A COLLECTIVE EVERETT, LOTS OF STRATEGIES TO BE EXPLORED THAT WILL BE IMPLEMENTED AT SOME POINT BUT OF COURSE A LOT OF THE FOCUS INITIALLY HAS BEEN ON ENROLLMENT AND SHIFTING TOWARD PUTTING ADDITIONAL EFFORT OF RETENTION IS IN THE PIPELINE AND OF COURSE INFORMATION RETURNING RESULTS, SOME THINGS IN THIS CONTINUUM, WE THINK BECOMES A CIRCLE SO RETURNING, MAKING INFORMATION AVAILABLE TO PEOPLE, PERHAPS ENGAGING THEM IN THAT WAY WILL MAKE THEM MORE LIKELY TO STAY IN THE STUDY. SO ENGAGEMENT IS BI DIRECTIONAL WHICH MEANS THERE HAS TO BE SOME GIVE BOTH WAYS. IF YOU ARE ENGAGING PEOPLE, YOU HAVE TO BE ABLE TO LEARN SOMETHING YOURSELF, YOU HAVE TO HAVE THE HUMILITY TO KNOW THAT YOU DON'T KNOW EVERYTHING AND YOU ALSO HAVE TO HAVE SOME CULTURAL ABILITY BECAUSE YOU MAY BE INTERACT WING WITH PEOPLE AND I THINK EVERYBODY IS DIFFERENT BUT THAT IS TYPICALLY HOW I APPROACH THESE THINGS. NO ONE IS EXACTLY LIKE ME SO I ALWAYS HAVE SOMETHING TO LEARN AND I THINK THAT IS REALLY IMPORTANT AS WE TALK ABOUT THE DIVERSITY THAT WE INTEND TO HAVE HERE. I AM GLAD THAT WITHIN THE PROGRAM, I WOULD SAY I AM HAVING TO SAY THIS INFREQUENTLY ABOUT WHY ENGAGEMENT IS IMPORTANT BUT I THINK STILL THERE ARE MANY PEOPLE AS WE'RE BUILDING THIS PROGRAM AND ENGAGING AT THIS LEVEL ARE LEERY AS TO WHY WE NEED TO BRING THIS TO THE TABLE. SO IF YOU ARE DOING STUDIES IN DIABETES, YOU CAN BE THE BEST PHYSICIAN, EXPERT WITH DIABETES RESEARCH BUT IF YOU NEVER LIVED WITH DIABETES, NEVER HAD TO CHECK YOUR BLOOD SUGAR FOUR TIMES A DAY. NEVER BEEN THE FAMILY MEMBER OF SOMEONE WHO HAS DIABETES, YOU ARE MISSING A VERY BIG ASPECT OF OF WHAT IS IMPORTANT AND RELEVANT IN THAT RESEARCH. ENGAGEMENT IS NOT NEW. OVER TIME, THERE HAVE BEEN NEW TERMS USED FOR IT WHICH AGAIN IS WHY I LIKE TO SAY ENGAGEMENT IS NOT THE NEW OUTREACH, IT IS DIFFERENT, IT IS BI DIRECTIONAL BUT IT HAS BEEN HAPPENING FOR MANY YEARS. THIS LADDER OF PARTICIPATION IS FROM 199 AND THINKING ABOUT HOW WE ENGAGE PEOPLE AND MAKING SURE THAT WE'RE ELIMINATING THOSE STRATEGIES TO ENGAGEMENT WHICH IS WHY I REALLY APPRECIATE THE FOCUS ON PARTNERSHIPS HERE. OF COURSE OVER TIME IN THE LAST TEN OR 15 YEARS, THERE HAS BEEN INCREASED EMPHASIS ON ENGAGEMENT AND RESEARCH. PART OF THAT HAS BEEN DRIVEN BY THE QUARRY, PATIENT CENTER OUTCOMES RESEARCH INSTITUTE BUT ALSO MCAD, THE NATIONAL CENTER FOR TRANSLATIONA AL SCIENCE AS WELL AS OTHER NIH CENTERS THAT RECOGNIZE COMPLETENESS OF ENGAGEMENT AND EXPECTING IT EMBEDDED IN OUR WORK. SO THIS BOX HERE IS REALLY SHOWING A DIFFERENT WAY OF LOOKING AT THE LEVELS OF COMMUNITY INVOLVEMENT AND GOING FROM, AGAIN, SOME PEOPLE INCLUDING MYSELF WOULD SAY OUTREACH SHOULDN'T BE IN THIS SPOT WITH THE ENGAGEMENT BUT JUST GIVING YOU A SENSE OF HOW WE WANT TO PUSH MORE TOWARDS THE COLLABORATION AND SHARED LEADERSHIP OPPORTUNITIES WHEN POSSIBLE. SO BECAUSE PARTICIPATE TANKS AND PARTNERS AND ENGAGEMENT HAS BEEN SUCH A CRITICAL PART OF ALL OF US, SOME OF THESE ACTIVITIES STARTED BEFORE THE PROGRAM WAS LAUNCHED. SO I HAD THE OPPORTUNITY TO LEAD SOME OF THE WORK IN OUR PILOT BACK IN 2016. WE WENT AROUND THE COUNTRY. WE DID 7/7 COMMUNITY ENGAGEMENT STUDIOS, A ROUNDTABLE SESSION WHERE WE PRESENTED THE CONCEPT OF PRECISION MEDICINE, TALKED ABOUT THE ENROLLMENT CRITERIA, TALKED ABOUT THE CONSENTING PROCESS, RETURN OF VALUE. SO WE HAVE CONVERSATIONS WITH PEOPLE, MANY OF WHOM HAD NOT PARTICIPATED IN CLINICAL RESEARCH PREVIOUSLY AND I AM REALLY PLEASED WITH OUR ABILITY TO BRING TOGETHER A LARGE NUMBER OF RACIAL AND ETHIC MINORITIES. THERE WERE 46 PERCENT -- NOW HOPSLY, I THOUGHT THAT THE PROGRAM WOULD BE NOWHERE NEAR THIS WITH ENROLLMENT SO I APPRECIATE THAT AND BEING WRONG WITH MORE THAN 50 PERCENT OF THE PEOPLE ENROLLED SO FAR BEING RACIAL AND ETHNIC MINORITY. YOU CAN SEE WE WENT TO MANY PLACES ACROSS THE COUNTRY. WE WERE IN CHURCH BASEMENTS ON THE SOUTH SIDE OF CHICAGO, WE WERE WORKING WITH ADOLESCENTS AND YOUNG PEOPLE WHO ARE TRANSGENDER IN SOUTH FLORIDA, AND I WAS NOT EXPECTING TO BE IN SOUTH DAKOTA BUT THERE I WAS WITH PEOPLE FROM RAO*URL COMMUNITIES AND WE -- RURAL COMMUNITIES AND WE DIDN'T SAY HEY, NIH, COME GIVE US INPUT BUT WORKED WITH COMMUNITY ORGANIZATIONS TO SAY WE NEED YOU TO HELP US BECAUSE THIS IS SO IMPORTANT, WILL YOU INVITE YOUR CONSTITUENTS, YOUR COMMUNITY MEMBERS OUT TO GIVE US INPUT AND SO I THINK THAT IS REALLY THE ONLY WAY WE WERE ABLE TO DO THAT. THERE WAS ALSO A MEETING, NATIONAL MEETING FROM BETHESDA IN 2018 ORGANIZED BY HCM AND LIZ CONE, THAT WAS EARLY ON TO SAY WE NEED TO TALK TO COMMUNITY PARTNERS, HAVE THEM AT THE TABLE TO SHE CAN UNDERSTAND HOW WE WANT TO ENGAGE, WHAT THE PROCESS SHOULD BE. AND VERY EARLY IN THE PROGRAM, WE SAID HEY, WE DON'T NEED PARTICIPANTS YET BUT WE NEED THE VOICES OF PEOPLE WHO REPRESENT POTENTIAL PARTICIPANT COMMUNITIES. SO IN THE FALL OF 2016, WE HAD A NOMINATIONS PROCESS WHERE INDIVIDUALS FROM ACROSS THE COUNTRY WERE NOMINATED FOR THE STEERING COMMITTEE AND THEN WE SELECTED THREE INDIVIDUALS -- ACTUALLY, MS. PATRICIA BUTZ HAD BEEN INVOLVED VERY EARLY ON IN THE PROGRAM, THE FIRST LADY OF THE ABYSINIAN CHURCH AND MANY OF YOU WHO KNOW HER KNOW THAT SHE IS NOT HESITATING TO SHARE HER THOUGHTS. THEN WE HAVE STEVE MIKITA AND KARL SURKAN WHO HAVE BEEN VERY INVOLVED WITH THE PROGRAM, WORK GROUPS, TASK FORCES, SPEAKING OFTEN AND I SAW KARL EARLIER TODAY SO THANK YOU SO MUCH FOR YOUR CONTRIBUTIONS TO THE PROGRAM. SO I WILL SPEND MY LAST LITTLE BIT OF TIME TALKING ABOUT OUR ENA GAUGEMENT CORE WHICH IS REALLY FOCUSED ON THE PARTICIPANTS AS PARTNERS ASPECTS OF ENGAGEMENT. SO I LEAD IT ALONG WITH SOME REALLY TALENTED FACULTY AND RESEARCHERS. KARIM WATSON AT THE UNIVERSITY OF ILLINOIS IN CHICAGO, LEADS OUR PARTICIPANT AMBASSADORS GROUPS AND NOW HE HAS CO-LEADERS, TWO OF OUR PARTICIPANT AMBASSADORS NOW CO-CHAIRING THAT WITH HIM. AND ALSO WHO I AM SURE MANY OF YOU KNOW, LAURA IS AT VANDERBILT AND HAS BEEN INSTRUMENTAL IN HELPING US THINK THROUGH OUR RIGOROUS EVALUATION TOOLS TO UNDERSTAND HOW ENGAGESOME IMPACTING PROGRAMS AND LIZ CONE WHO LIVES IN NEW YORK HAS BEEN REALLY HELPFUL IN THINKING ABOUT THE VISION AND AT THE TABLE FROM THE BEGINNING WITH OUR ENGAGEHAM STRATEGIES. ALICIA IS ON MY TEAM AND WORKS CLOSELY AND DATA DAY WITH OUR PARTICIPANT AMBASSADORS, ANSWER THE CALLS, TEXT MESSAGES, THEY CAN TRACK PEOPLE DOWN. ANYTHING THEY NEED, THEY KNOW WHEN PEOPLE ARE WORKING, WHEN THEY ARE ON VACATION, WHO HAS DOGS OR CATS, THEY KNOW ABOUT THE FAMILY MEMBERS, AND THIS IS REALLY IMPORTANT FOR THE RELATIONSHIP PIECE. KATE AND KATHERINE WORK CLOSELY WITH LAWYER A RA IN HELPING WITH OUR EVALUATION WORK AND I BELIEVE KATHLEEN THERE IN IS HERE TODAY AS WELL. SO OUR MISSION, IS TO FOCUS ON THE PARTICIPANTS AS PARTNERS IN DESIGNING THE STUDY. OUR AIMS ARE TO FULLY INTEGRATE THESE PARTICIPANTS AS PARTNERS IN THE RE RESEARCH AND THAT MEANS MAKING SURE THEY ARE REALLY EMBEDDED IN FULL NUMBERS WHEN PARTICIPATING ON TEAMS. WE NEED TO ALSO ASSESS THE IMPACTS OF RESEARCH. IT HAS BEEN ONE OF MY CAREER GOALS TO INSURE WE HAVE WAYS OF MEASURING ENGAGE SO*PLT WE CAN REALLY DEMONSTRATE THE IMPACT OF THE WORK. WE HAVE INITIATIVES UNDERWAY ALREADY AND SOME THAT ARE PLANNED SO WE CURRENTLY HAVE FOUR INDIVIDUALS WHO ARE ON OUR STEERING COMMITTEE. TILL HE AND I WILL TELL YOU BRIEFLY THAT I MET WITH SEVERAL OTHERS TO TALK ABOUT MY VISION FOR PARTICIPATING PARTNERS FOR THEM TO SAY THE STEERING COMMITTEE IS GREAT BUT IT IS BIG AND WE ALSO WANT PARTICIPANTS ON THE EXECUTIVE COMMITTEE. SO THAT WAS NOT MY INITIAL PLAN, IT WAS SOMETHING THEY ASKED FOR AND I COULDN'T BE MORE EXCITED THAT WE HAVE TWO INDIVIDUALS WHO ARE ON OUR EXECUTIVE COMMITTEE WHICH IS MUCH SMALLER THAN 10, 11, 12 PEOPLE, SO THEIR VOICES ARE MORE LIKELY TO BE HEARD THERE. WE HAVE PARTICIPANT S ON OUR ADVISORY PANEL AND OUR PARTICIPANTS AMBASSADOR WILL TELL YOU ABOUT THESE SHORTLY. WE ALSO HAVE A GROUP THINK TANK, A A GROUP OF PEOPLE IN THE D.C. AREA WHO WOULD REACT TO THINGS FROM THE LEADERSHIP OF THE PROGRAM. SO WE HAD A VERY TIGHT TIME LINE. THESE SLIDES WILL BE AVAILABLE TO YOU BUT REALLY JUST TO SHOW OUR PROCESS OVER TIME REALLY INVOLVED LOTS OF STEPS BUT ALL OF THEM INCLUDED HAVING A WAY TO ACTUALLY BROADLY SOLICIT A PARTICIPATION FOR ALL OF THESE ROLES IN OUR GUIDANCE PROCESS. OUR ENGAGEMENT CORE, ONE, WE NEED TO PROVIDE CLEAR EXPECTATIONS AND RESOURCES. IT IS OUR GOAL TO MAKE SURE ALL THE PARTICIPANTS KNOW WHAT THEY ARE EXPECTED TO DO AND THAT THEY HAVE THIS INFORMATION, THE RESOURCES, AHEAD OF TIME. SO ONE OF THE EARLIER QUESTIONS WITH STEPH AND GWEN AND OTHERS WHO LEAD THE EXECUTIVE STEERING COMMITTEE AND ADVISORY COUNCIL, OKAY, I NEED TO HAVE THE MATERIALS IN ADVANCE SO THE PARTICIPANTS HAVE TIME TO REVIEW THEM. AND SO THAT WAS THE FIRST -- THEY ARE WEEKLY MEETINGS AND GO HOW CAN WE -- AND LIKE OKAY, THESE PEOPLE WORK, THEY HAVE JOBS, THEY ARE TAKING TIME OUT OF THEIR DAY TO ATTEND THESE WEEKLY MEETINGS. WE CANNOT SEND THEM THE INFORMATION, YOU KNOW, THE MORNING OF AND EXPECT THAT THEY WILL BE FULLY PREPARED TO PARTICIPATE. AND SO I REALLY DO WANT TO THANK THE PROGRAM FOR MAKING THE EFFORT. WE ACTUALLY HAVE BEEN TRACKING THESE SO WE HAVE A SPREADSHEET WITH THE TIME THAT THE SLIDES WENT OUT AND THE WHETHER OR NOT IT IS A REASONABLE TIME. WE HAVE ALL SORT OF STRAT FEES IN -- STRATEGIES IN PLACE AND THIS IS REALLY ABOUT CULTURE CHANGE AS WELL. I HAVE NO DOUBT OUR PARTICIPANTS CAN PROVIDE DATA AND MEANINGFULLY ENGAGE IN ANY PROGRAM BUT THEY HAVE TO HAVE THE TIME AND RESOURCES SO PART OF THAT IS MAKING SURE THEY HAVE APPROPRIATE COMPENSATION FOR PARTICIPATING IN THE MEETINGS, WE ARRANGE THEIR TRAVEL IN ADVANCE, WE HAVE SOME INDIVIDUALS WHO ARE REQUIRED TRAVEL COMPANIONS BECAUSE OF OF THEIR HEALTH CONDITIONS. WE WANT THEM TO ALL HAVE THE TRAVEL PAID IN ADVANCE, HAVE AN ADVANCE FOR THEIR FOOD AND PER DEIM DE DIEM. AND THEN WE WANT YOU TO KNOW WHO THEIR FACES ARE, WE HAVE TWO ON THE EXECUTIVE COMMITTEE, AND TWO ARE ON OUR ADVISORY PANEL. THEY HAVE FULL RIGHTS VOTING ACTIVITIES, WE HAVE PARTICIPANT AM PASS SCORES. I THINK FOUR OF THEM ARE HERE. THERE WERE SUPPOSED TO BE FIVE. MIGUEL'S FLIGHT WAS CANCELED SO HE IS STILL IN ARIZONA BUT I BELIEVE HE IS ONLINE. IF YOU ARE HERE, IF YOU WANT TO STAND AND WAVE YOUR HANDS SO PEOPLE SEE YOU AND KNOW YOU HAVE THE FIRST RIGHT TO SPEAK IN ANY OF THOSE -- [APPLAUSE] >> ANY SESSION, THAT IS MY CALL, THEY GET TO VOICE THEIR OPINION BEFORE ANYBODY ELSE AND THEY CAN INTERRUPT YOU BUT YOU CAN'T INTERRUPT THEM. THEY WERE NOMINATED BY THEIR HEALTH PROVIDER ORGANIZATIONS OR THEY ARE ON EITHER A COMMUNITY OR PARTICIPANT ADVISORY BOARD. FOR THE MASTERS, THESE INDIVIDUALS ARE SELECTED TO HELP PROVIDE THE HEALTH PROVIDER ORGANIZATIONS, DIRECT VOLUNTEERS AND VA. WE ALSO HAVE MONTHLY MEETINGS AND SERVE ON DIFFERENT TASK FORCES AND THIS IS JUST AN EXAMPLE OF SOME OF THE GOVERNANCE BODIES. I ALSO WANT TO THANK KATE AND HER TEAM FOR THEIR WILLINGNESS TO BE SO RESPONSIVE AND ACCOMMODATING WHEN WE LEARNED THAT THERE WAS INTEREST IN HAVING OUR PARTICIPATE ATTACHMENT AMBASSADORS ATTEND, WE SAID WELL, THEY DON'T KNOW WHAT ELSI IS SO WE NEED HOMEWORK FOR THEM, MAKE SURE THAT THEY HAVE PAPERS TO READ, NEED A WEBINAR SO THEY CAN HEAR AND ASK QUESTIONS AND WE REALLY APPRECIATE, YOU KNOW, YOUR RESPONSES SAYING OKAY, WHATEVER YOU NEED, YOU NEED MORE, LET'S MAKE IT HAPPEN SO THIS IS THE KIND OF COLLABORATIVENESS THAT WE HAVE TO HAVE IF WE'RE GOING TO FULLY ENGAGE IN PARTICIPANT AND THEN THESE ARE OUR THINK TANK MEMBERS. THESE ARE OUR PARTICIPANTS IN PERSON IN D.C. WHERE WE HAD OUR FIRST RETREAT LAST YEAR AND ALSO PRESENTING SOME OF THEIR FEEDBACK AT THE STEERING COMMITTEE, IN THAT LOWER RIGHT CORNER. I WILL END HERE WITH AGAIN, EVALUATING WHAT WE DO IS REALLY IMPORTANT. WE HAVE LOTS OF OPPORTUNITY TO THINK ABOUT HOW WE ENGAGE AND THE POTENTIAL OUTCOMES, I THINK, ARE IMPORTANT BOTH FOR ALL OF US BUT WELL BEYOND SO WHAT WILL WE LEARN FROM THE ENGAGEMENT PROCESS, HOW WILL THEY CHANGE THE RESEARCH, HOW WILL RESEARCHERS BE CHANGED AS A RESULT OF THIS PROCESS? WE'RE ALREADY SEEING SOME OF THE CULTURE CHANGE. EACH OF OUR STEERING COMMITTEE MEMBERS HAVE MENTORS WHO ARE ALSO ON THE STEERING COMMITTEE AND I THINK A LOT OF THAT WILL HOPEFULLY BE SHIFTING TO A MORE PARTICIPANT CENTER, MORE DELIVERING RESEARCH REALLY RELEVANT TO POPULATIONS BROADLY SO THANK YOU. [APPLAUSE] >> SO DOES ANYONE HAVE QUESTIONS? AND IF YOU DO HAVE QUESTIONS, I WOULD ASK YOU COME TO THE MIC AND IF YOU CAN'T GET TO THE MIC, RAISE YOUR HAND AND SOMEONE WILL BRING A MIC TO YOU. NO QUESTIONS? OH, WE HAVE A QUESTION, ALL RIGHT. >> I AM NEVER SURE WHEN TO START ASKING QUESTIONS OR NOT BUT I HAVE A QUESTION FOR CONSUELO AND THAT IS -- FIRST OF ALL, THANKS BECAUSE YOU DID A GREAT JOB OF DISEFFUSING ME FROM MY CONCEPTIONS. BUT WHAT IS THE WAY YOU SEE THE RELATIONSHIP BETWEEN THE PARTICIPANT AMBASSADORS AND THE PARTICIPANTS THEMSELVES? DO THEY KNOW ABOUT THEM ARE, THEY CONTACTING THEM, IS IT A WAY OF, YOU KNOW, MAINTAINING PEOPLE IN DIFFERENT -- THE RELATIONSHIP TO RESEARCH AND RESEARCHERS, I THINK, NEEDS TO BE CLEAR BUT THAT ONE I AM JUST WONDERING ABOUT. >> SO WE THINK -- FOR OUR PARTICIPANT AMBASSADORS IN PARTICULAR, THEY ARE CONNECTED TO OTHERS IN THEIR LOCAL AREAS AS PART OF THEIR ADVISORY COMMITTEES OR ADVISORY BOARDS. SO THAT IS MORE OF A FORMAL CONNECTION THEY HAVE. BUT THEY ARE ALL REALLY CONNECTED TO A BROADER COMMUNITY OF PEOPLE AND ONE OF THE INTERESTING THINGS I WOULD SAY EARLY ON THAT WE HEARD IS THAT THEY WANT TO BE CHAMPIONS AND ADVOCATES FOR THE RESEARCH. THEY WANT TO KNOW WHAT THEY CAN DO, WHEN THEY CAN DO IT, THEY WANT TO BOTH HELP -- YOU KNOW MAKE THE PROGRAM GREAT BUT ALSO SHARE, YOU KNOW, CHALLENGES, SUCCESSES BROADLY. THAT IS NOT A REQUIREMENT THAT WE HAVE FOR THEM. WE DO RECOGNIZE THAT PEOPLE WHO ARE PARTICIPANT AMBASSADORS KNOW MORE ABOUT THE PROGRAM, THEY ARE REALLY BRINGING IN A VIEWPOINT THAT IS NOT NECESSARILY FROM A RESEARCHER BUT MORE INFORMED ABOUT THE PROGRAM WHICH IS WHY I DIDN'T REALLY TALK ABOUT IT BUT ONE OF OUR STRATEGIES WILL ALSO BE TO MAKE SURE THAT WE ARE NOW THINKING ABOUT WHAT RESULT WILL BE RETURNED AND HOW THEY WILL BE RETURNED, THAT WILL REQUIRE INPUT FROM A MUCH LARGER GROUP OF PEOPLE THAN 22 OR 6. SO WE HAVE THOSE STRAT DECEMBER PLANNED FOR HOW WE WILL POLL THEM, BRING IN THOSE OTHER VOICES SO WE'RE REALLY CAPTURING THE DIVERSITY OF THOUGHT AROUND THOSE. I THINK OUR PARTICIPANT AM BOSS CARS -- AMBASSADORS WILL HELP US WITH THAT, WHO ARE WE MISSING, WHOSE VOICES ARE WE MISSING, I THINK THOSE STRATEGIES WILL BE INCREDIBLY HELPFUL BUT IT IS ONLY 30 PEOPLE. >> HELLO? THANKS, JON. THANK YOU VERY MUCH FOR YOUR SLIDES AND YOUR PRESENTATION, CONSUELO. I GUESS I HAVE TWO QUESTIONS. ONE IS I WOULD LIKE TO HEAR A LITTLE BIT ABOUT HOW THE ACTIVE INVOLVEMENT IN THE ENGAGEMENT PROCESS HAS CHANGED OR MOVED SORT OF ALL OF US IN GOVERNANCE THING IN DIFFERENT DIRECTIONS AS WE INTO THIS PHASE OF THINKING ABOUT THE ISSUES WE MIGHT BE THINKING OF IN THAT CONTEXT. AND THEN TWO IS THINKING THROUGH HOW -- THAT LAST SLIDE, I WAS LIKE WHOA, IT IS REALLY DENSE BECAUSE I FEEL LIKE SOME OF THAT IS THERE IN PARTICULAR AND FOR THOSE OF US TO NOT BE THINKING ABOUT OUR ARM CHAIR QUESTIONS, MORE INDIVIDUAL NARROW SEARCH PROGRAMS, HOW THE DATA WE HAVE BEEN CONTRIBUTING IS HELPING. >> I THINK FOR THE WORK THAT WE DID IN THE PILOT, WE HAVE SOME CLEAR, YOU KNOW, HOW THE ENGAGEMENT HAS CHANGED THE PROGRAM SO SPECIFIC INPUT FROM THE ENGAGEMENT PILOT LED TO A CHANGE IN WHICH THE PROGRAM WAS NOT INTENDING TO PROVIDE A $25 INCENTIVE FOR THE PROGRAM. THAT WAS SOMETHING WE HEARD, YOU KNOW, REPEATEDLY IN OUR ENGAGING THE COMMUNITY, THAT WE WANT TO BE ENGAGED BUT THIS IS TIME AND WE NEED INITIALLY SOME INCENTIVE TO HELP OFFSET THE REQUIREMENTS OF BEING INVOLVED. I THINK EARLY ON, STAFF AND OTHERS WHO HAVE BEEN INVOLVED AT THE VERY BEGINNING CAN CORRECT ME IN MY RECOLLECTION IS WRONG BUT THERE WAS REALLY MORE OF AN INSISTENCE EARLY ON THAT EVERYBODY WAS GOING TO COME IN DIGITALLY. THERE WAS NOT THIS ACCEPTANCE THAT PEOPLE ARE GOING TO NEED MORE AWARENESS AND WE CAN'T JUST HAVE THEM SCAN A CODE AND EXPECT THAT THEY ARE GOING TO BE IN SO I THINK THE EXPECTATION OF ENGAGEMENT, MAKING WAY FOR THAT AWARENESS AND ACCEPTANCE OPPORTUNITY WAS THERE AND THEN ALSO THE DIVERSITY AROUND WHAT PEOPLE WILL VALUE AS INFORMATION BACK. AND I THINK AS PART OF THE FOCUSSED COMMITTEE REPORT, THERE WAS A LOOK AT DIGITAL AND KELLER ESR, PEOPLE NEED PARTICULAR THINGS RETURNED TO THEM SO TO FOCUS ON THE OPTIONS AND THINGS THAT MIGHT BE RETURNED. WE'RE STILL ANALYZING SOME OF THE EARLY FEEDBACK. THE COMMITTEE CHAIRS HAVE TO EVALUATE THE PROCESS. HOW IS THE PARTICIPATION ENGAGEMENT CHANGING THE DIRECTION OF THE COURSE, HOW ARE THE VOICES OF THE PARTICIPANTS BEING INCORPORATED, THOSE ARE THINGS WE'RE CAP WHICH YOUING BOTH -- CAPTURING. INPUT AND CHANGE, LOTS OF THINGS THERE. WE HAVE A READINESS FOR ENGAGEMENT THAT WE SENT TO EVERYBODY ON THE CONSORTIUM TO REALLY UNDERSTAND HOW THEY THINK PARTICIPANTS WILL BE ABLE TO CONTRIBUTE TO THE PROGRAM, SHOULD THEY BE IN SHARED LEADERSHIP ROLES AND SO WE WILL BE ASSESSING THAT OVER TIME AS WELL. SO WE DON'T HAVE ANYTHING FROM THE MOST RECENT YEAR OF ENGAGEMENT BUT I LOOK FORWARD TO SHARING IT. >> ALL RIGHT, DON'T KILL ME BUT I AM GOING TO CUT OFF QUESTIONS FOR RIGHT NOW AND TAKE A 10-MINUTE BREAK. I THINK -- IS IT 10:37? IF WE CAN BE BACK BY 10:47 -- YES, JON HAS KINDLY PROVIDED US WITH COFFEE FOR THOSE OF YOU WHO ARE JETLAGGED, THANK YOU, SIR. AROUND THE CORNER THERE. BACK IN TEN MINUTES, GUYS. WE'RE GOING TO START BACK IN WITH SOME MORE INFORMATION ON THE DATA AND RESOURCE COLLECTION STRUCTURE FROM DOCTORS XIA WEIYI AND DIKSHYA BASTAKOTY. >> THANK YOU, KATE. SO MY NAME IS DIKSHYA BASTAKOTY, WITH VANDERBILT UNIVERSITY, I WORK WITH INFORMATION ON POLICY SECURITY WORKING ON THE DELIVERABLES OF THE COMMITTEE AND I AM REALLY EXCITED TODAY TO SPEAK WITH YOU ALONG WITH WEIY TO TALK ABOUT THE FRAMEWORK WE HAVE BEEN DEVELOPING FOR THE PROGRAM. SO IN THE LAST TALKS, YOU HEARD ABOUT, YOU KNOW, THE PROGRAM'S OVERALL POLICIES AND FRAMEWORK GUIDING THE PROGRAM SO IN THIS TALK, WE WANT TO DO A LITTLE BIT MORE OF A DEEPER DIVE OF THE POLICIES GUIDING THE DATA ACCESS AND ALSO TALK ABOUT THE DATA ITSELF AND WHAT IT LOOKS LIKE AND WHAT CHANGES WE MIGHT BE DOING TO THE DATA TO MAKE SURE THAT WE PROTECT THE PRIVACY OF THE PARTICIPANTS PROVIDING DATA TO THE PROGRAM. SO WE HAVE A OVERVIEW OF TYPES AND THEN TALK ABOUT ACCESS AND THEN DATA PRIVACY WITHIN THE REGISTER HERE AND BEYOND AND A LITTLE BIT OF WHAT KIND OF DATA RESOURCES WE MAY BE GETTING. AND THIS MORNING, THE PRINCIPLES AND POLICIES THAT GUIDE ALL OF THE RESEARCH PROGRAM, TWO OF THE PRINCIPLES THAT ARE PARTICULARLY RELEVANT ARE THE SOMEWHAT OPPOSING PRINCIPLES OF BROAD AND OPEN ACCESS TO THE DATA AND COMMITMENT TO PROTECTING PRIVACY. SO THE PROGRAM IS GUIDED BY ITS GOALS TO MAKE SURE THE DATA SOURCES ARE AVAILABLE TO ACADEMIC AND NONACADEMIC RESEARCHERS ACROSS THE WORLD AND ACROSS NECESSARY BARRIERS OF ACCESS BUT THAT ALSO PROVIDES CHALLENGES TO PROTECTING PRIVACY. SO WITH ALL OF THE WORK WE HAVE DONE OVER THE PAST COUPLE OF YEARS IN DEVELOPING PRIVACY POLICIES, WE HAVE TRIED TO STRIKE A BALANCE BETWEEN THE TWO AND THEN ANOTHER ASPECT OF THE PROGRAM THAT IS UNIQUE TO ALL OF US AND -- IS THE RICHNESS OF THE DATA THAT WE'RE COLLECTING AND HAS A DIRECT BEARING ON THE ISSUE OF PRIVACY. AND WE WILL TALK A LIT MORE ABOUT -- LITTLE MORE ABOUT THAT IN HER TALK BUT WE'RE COLLECTING DATA FROM MANY DIFFERENT SOURCES. MANY DATA SOURCES THAT WE'RE TRYING TO COLLECT DATA FROM. ALL OF THIS DATA GOES THROUGH -- IN THE DATA AND RESOURCE CENTER, GOES THROUGH A PROCESS OF DATA MAT TRICK LAKES INCLUDING HARMONIZATION, CLEANING AND QUALITY ASSESSMENT THAT YOU SEE OF THE DATA AND THEN TO APPLY THE PRIVACY METHODOLOGY THAT WE HAVE DEVELOPED AND THEN IT ENDS UP IN WHAT WE CALL THE CURATED DATA REPOSITORY OF THE CDR. IN THE CDR, WE TALK ABOUT THE DATA BELONGING TO THREE DIFFERENT YEARS ROUGHLY. AT THE BOTTOM RUNG IS THE STATISTICS AND AGO GANT COUNTS, FOR INSTANCE, HOW MANY ANSWERED YES TO A SPECIFIC SURVEY QUESTION, HOW MANY PARTICIPANTS HAD AT LEAST ONE OCCURRENCE OF A DIAGNOSIS CODE FOR HEART DISEASE IN THE RECORD AND THOSE KIND OF ARE BROKEN DOWN BY DEMOGRAPHICS AND THIS IS PUBLICLY ACCESSIBLE, NO LOG-IN REQUIRED, AND AS YOU HEARD ALREADY, THIS DATA IS ACTUALLY ALREADY AVAILABLE TO ALL OF YOU HERE TO BROWSE, USING THE DATA BROWSER THAT IS IN THE ALL OF US WEBSITE. THE SECOND TIER IS A REGISTERED TIER AND SO THERE ARE CERTAIN STEPS TO GETTING ACCESS TO THIS REGISTERED TIER AND I WILL TALK ABOUT IT IN A LOT MORE DETAIL IN THE NEXT SLIDE BUT IT INCLUDE ARE INDIVIDUAL LEVEL DATA THAT HAVE BEEN AMENDED TO PROTECT A PERSON'S PRIVACY. AND SO THIS DATA HERE IS ACCESSIBLE TO A CLOUD-BASED DATA PLATFORM AND THIS IS A TOOL THAT AGGREGATES ALL OF THE DATA SO THAT PEOPLE CAN LOG IN, THE AUTHORIZED INDIVIDUALS CAN ACCESS DATA FOR THEIR STUDIES, FOR THE COHORT AND DO DATA ANALYTICS AND LIKE THAT. AND THEN AN EVEN MORE SECURED TIER IS THE CONTROLED TIER WHICH HAS ACCESS REQUIREMENT THAT INCLUDE EVERYTHING IN THE REGISTERED TIER WITH ADDITIONAL REQUIREMENTS AND WE'RE STILL WORKING THROUGH WHAT THOSE WILL LOOK LIKE BUT IT WILL INCLUDE MORE DATA TYPES AND MORE GRANULAR DATA THAN THE REGISTERED TIER AND THEN OF COURSE PRESENT SOME ADDITIONAL PRIVACY CONCERNS AND THAT ALSO WILL BE ACCESSIBLE TO THE RESEARCER WORKBENCH. AND TODAY IN OUR TALK, WE'RE GOING TO TALK MORE ABOUT THE REGISTERED TIER BECAUSE THAT IS THE TIER WE'RE GETTING READY TO LAUNCH IN WINTER 2019 SO TOWARD THE END OF THIS YEAR. SO IN THINKING ABOUT ACCESS TO THE REGISTERED TIER, ONE THING THAT I WANT TO KIND OF REMIND EVERYONE OF IS, YOU KNOW, THE EMPLOYMENT TO MAKING THE DATA BROADLY ACCESSIBLE TO ACADEMIC RESEARCHERS AS WELL AS NONACADEMIC RESEARCHERS, COMMUNITY SCIENTISTS, THAT THE PROGRAM HAS THE ACCESS PROGRAM THAT REALLY ALLIANCE WITH OUR EMPLOYMENT. COMMITMENT. SO WHAT YOU WILL IN THE IS YOU NEED TO DO THE RESEARCH PROGRAM AND THEY ARE DIFFERENT FROM WHAT WE HAVE BECOME FAMILIAR WITH FOR RESOURCES OF THIS KIND. SO THE FIRST STEP IN REGISTRATION TO ACCESS THE REGISTER HERE IS VERIFICATION OF IDENTITY. SO EACH USER WILL BE REQUIRED TO UNDERGO A PROCESS OF ELECTRONIC IDENTITY VALIDATION PROCESS SO MAKE SURE THAT WE CAN VERIFY THAT THEY ARE WHO THEY SAY THEY ARE AND INITIALLY AT THE VERY BEGINNING OF THE WINTER 2019 LAUNCH, WE'RE ACTUALLY USING THE RA RESEARCH ACCOUNT SO IT WILL BE RESEARCHERS VETTED BY THE NIH AND A LOT MORE NARROWER THAN THE BROAD ACCESS WE'RE AIMING FOR BUT THEN SOON AFTER THAT, WE WILL PLAN TO USE AN ELECTRONIC VERIFICATION PLATFORM SO USERS WHO DON'T HAVE AN ACCOUNT CAN ACTUALLY LOG IN AND ACCESS THE RESOURCE. AND THE SECOND STEPS IS DATA PASSWORD REGISTRATION WHERE THE USERS REGISTER THEMSELVES AND PROVIDE INFORMATION ABOUT THEMSELVES INCLUDING NAME, INSTITUTIONAL AFFILIATION, GOALS AND OTHER INFORMATION. AND THE TERM DATA PASSPORT HERE IS PARTICULARLY RELEVANT BECAUSE IT TALKS ABOUT THE UNIQUE MODEL OF FACETS THAT WE'RE ADOPTING FOR THE RESEARCH PROGRAM. SO TRADITIONALLY FOR RESOURCES OF THIS KIND, GENERALLY WE -- THE RESOURCES VET THE RESEARCH PROGRAMS THAT ARE AUTHORIZED FOR ACCESS BUT ALL OF US ACTUALLY AUTHORIZE THIS AND INCLUDE RESEARCHERS FOR ACCESS SO WHENEVER YOU HAVE A DATA PASSPORT THAT YOU HAVE ACQUIRED, YOU CAN USE THE RESOURCE FOR MULTIPLE DIFFERENT RESEARCH PROJECTS AND COME BACK AND ASK FOR DATA FOR MANY DIFFERENT TYPES OF RESEARCH PROJECTS WITHOUT HAVING TO ASK FOR NEW RESEARCH EVERY TIME YOU ARE ACCESSING THE DATA SO REMOVING THE NECESSARY BARRIERS AND MAKING ACCESS MORE EASIER. THE THIRD STEP INCLUDES RESEARCH ETHICS STREAM AND THIS IS A REQUIREMENT FOR EVERY USER REGARDLESS OF THEIR HIERARCHY IN THE ORGANIZATION OR EXPERIENCE WITH RESEARCH SO EVERY RESEARCHER GOES THROUGH A NUMBER OF TRAINING MODULES AT NLM AND THAT THE TRAINING AND EDUCATION CENTER ARE DEVELOPING AND THESE TRAINING MODULES ARE DESIGNED SPECIFICALLY FOR THE ALL OF US USERS PROGRAM. AND THEN FINALLY, EACH RESEARCHER IS REQUIRED TO ATTEST TO THE PROJECT. SO TO ACTUALLY ACCESS THE RESEARCH PROGRAMS, THE USER WILL LOG INTO THE WORKBENCH AND THEN WE UNITE WHAT WE'RE CALLING WORK SPACES THAT WILL BE PROJECT SPECIFIC AND WITHIN THOSE WORK SPACES, THEY CAN COLLABORATE TOGETHER AND ACCESS THE DATA AND WORK ON THE DATA. AND THEN AS A REQUIREMENT FOR ACCESS, EACH RESEARCHER IS REQUIRED TO ACTUALLY PROVIDE A DESCRIPTION BEFORE AND AFTER DESCRIPTION FOR THE PURPOSE FOR WHICH THEY ACCESSED THE DATA AND ALL OF THAT INFORMATION INCLUDING NAME AND AFFILIATION OF THE RESEARCHER WILL BE DISPLAYED PUBLICLY ON THE WEBSITE WHERE EVERYBODY CAN ACCESS THAT. AND SO WE TALK A LOT ABOUT THE PROCESSING FOR THE ALL OF US RESEARCH PROGRAM IS ENABLING EASY ACCESS TO THE DATA RESOURCE SO WE CAN AUTHORIZE A LOT OF REALLY GOOD RESEARCH IN THE PROGRAM BUT WITH THAT COMES THE NEED TO MAKE SURE WE HAVE ENOUGH SAFEGUARDS IN PLACE TO PROTECT THE DATA AGAINST MISUSE AND MAKE SURE THE DATA IS BEING USED FOR GOOD RESEARCH PURPOSES. AND THERE ARE MANY SAFEGUARDS IN PLACE THAT ARE UNIQUE AND NOVEL TO THE ALL OF US RESEARCH PROGRAM. THE FIRST SAFEGUARD THAT I WANT TO HIGHLIGHT IS THAT THE PROGRAM HAS DEVELOPED THE RESEARCH WORKBENCH AS A TOOL THAT ALL RESEARCHERS CAN GO INTO, LOG INTO AND COLLABORATE WITHIN TO ACCESS THE DATA AND ANALYZE THE DATA AND WORK WITH THE DATA. AND NOBODY CAN ACTUALLY DOWNLOAD THE DATA AT INDIVIDUAL LEVELS FROM THE FORM. ALL OF THE ANALYSIS HAPPENS WITHIN THE RESEARCHER PLATFORM AND THEN ONLY ANALYZED RESULT THAT ARE AGGREGATED TO BUCKETS OF 20 OR MORE CAN BE TOWNLOADED OUT AND THAT PROVIDES A REALLY IMPORTANT SAFEGUARD FOR MAKING SURE THAT THE DATA IS IN THE PUT AT RISK OF REIDENTIFICATION AND OTHER RISKS. AND THE UPCOMING TALK FROM THE DATA AND RESOURCE CENTER WILL ACTUALLY TALK A WILL THE MORE ABOUT THE RESEARCHER PLATFORM AND OTHER TOOLS WE'RE USING AND DEVELOPING. THE SECOND SAFEGUARD THAT IS IN PLACE IS IN THE OVERSIGHT OF DATA USE. SO AS YOU RECALL, ANY MEMBER OF THE PUBLIC CAN REVIEW -- CAN VIEW THE RESEARCH PURPOSE DESCRIPTION THAT WAS PROVIDED BY THE RESEARCHER AT THE TIME OF WORK SHAYS CREATION THAT IS SPECIFIC TO THEIR PROJECTS AND THEN ANY MEMBER OF THE PUBLIC INCLUDING OUR PARTICIPANTS CAN REQUEST TO VIEW THAT IF THEY FIND CONCERNS ABOUT STIGMATIZATION OF RESEARCH AND THE BOARD WILL RESPOND TO THOSE CONCERNS AND THEY AUDIT USERS TO MAKE SURE THAT NOTHING THAT SHOULDN'T BE HAPPENING WITHIN THE PLATFORM ARE HAPPENING. ADDITIONALLY FOR ANY RESEARCHERS WHO ARE CONCERNED ABOUT POTENTIALLY STIGMATIZEING RESEARCH PARTICIPANTS THROUGH THEIR WORK, KNOWING ROAR OR UNKNOWINGLY CAN REQUEST REVIEW BY THE ACCESS BOARD AND IN THOSE CIRCUMSTANCES, THEY WILL WORK WITH THE RESEARCHER TO MAKE CHANGES OR ADJUST THE RESEARCH APPROACH SO THAT THE RESOURCE CAN ACTUALLY BE DONE IN A WAY THAT AVOIDS STIGMATIZATEON AND THIS IS DONE IN A WAY THAT IS COLLABORATIVE TO THE USER AND THEN LAST BUT NOT LEAST, AN IMPORTANT SET OF SAFEGUARDS ARE PLACED IN THE DATA ITSELF. WE HAVE ADOPTED PRIVACY METHODOLOGY THAT MAKES SURE THE DATA IS PROTECTED AGAINST IDENTIFICATION ATTACKS AND OTHER ATTACKS LIKE THAT AND WE, MY COLLEAGUE FROM VANDERBILT WHO WILL TALK A LOT MORE ABOUT THE WHAT, THE HOW AND THE WHY OF DATA PRIVACY FOR ALL OF US. THANK YOU. [APPLAUSE] >> THANKS, SO I AM WEIYI XIA FROM VANDERBILT, UNIVERSITY AND I AM WORKING ON THE CONSISTENCY METHODS AND TOOLS TO CONTINUALLY ACCESS AND MONITOR THE ALL OF US RESOURCE. SO TODAY'S TALK WILL FOCUS ON THE WHAT IS HAPPENING IN THE DATA AND PRIVACY SAFEGUARDS THAT ARE DIRECTLY BUILT INTO THE DATA ITSELF AND ESPECIALLYILY WILL SHARE THE THOUGHTS OF HOE WE MADE A DIFFERENCE AMONG THE DATA DOLLARS WE COLLECTED AND HOW WE MAKE THOSE HAPPEN AND WORK TO SHARE WITH THE USERS. SO THIS IS A CLOSER LOOK ON WHAT IS CURRENTLY AVAILABLE WITHIN THE RESOURCE. YOU CAN SEE THERE IS A SURVEY FOR ANSWERS FROM PARTICIPANT, PHYSICAL MEASUREMENTS AND HOW MANY DATA HE WANT TREES FOR EVERY PARTICIPANT WE HAVE NOW. SO WE HAVE LIKE 400 FOR AVERAGE PARTICIPANT AND 85 MEDICAL DIAGNOSES, 97 DRUGS THEY ARE USING AND ALSO IN THE FUTURE, THERE WILL BE GENOMIC DATA AND HOSPITAL DATA. SO THERE IS A LOT OF DATA. SO BEFORE WE DID THE ANALYSIS, THE FIRST QUESTION WE ASK OURSELVES IS HOW HAS IT BEEN DONE IN THE PAST THAT RESOURCES LIKE THIS GET SHARED? AND AS WE LOOK AT THE RESEARCH FROM THE BIOMEDICAL FIELD, USUALLY ONLY SHARED WITH THEIR COLLABORATOR, LIKE PEOPLE WOULD APPLY TO GET ACCESS TO THEM AND BECOME A KHRAEUB GREATER AND THEY WOULD ANALYZE THE DATA TOGETHER. SO THAT IS A VERY LIMITED SET OF PEOPLE WHO GET TO USE THE DATA, THE FULL DATA SET. AND ON THE OTHER END OF THE SPECTRUM IS THAT THEY WILL MAKE THE DATA SET MORE ACCESSIBLE WITH MORE USERS BUT FOR EXAMPLE, THE DATA SETS FROM THE DATABASE OF GENOMIC DATA TYPES, THEY MAKE THE RESEARCH AVAILABLE TO THE GROUPS THAT APPLIED TO IT BUT YOU CAN SEE THERE IS WAY LESS INFORMATION THEY HAVE FROM ALL A THE RESOURCES. SO WE ARE TRYING TO MAKE THE DATA BE ACCESSIBLE TO BASICALLY BE OPEN TO EVERYONE, THE PARTICIPANT LEVEL DATA SHOULD BE CAN ACCESSIBLE TO EVERYONE WITH A VALID I.D. SO THERE ARE THIS MANY PEOPLE AND WE DON'T KNOW A LOT ABOUT THEM, LIKE THE RESEARCHERS FROM THE INSTITUTION THAT WE HAVE BUILT A TRUST RELATIONSHIP WITH AND SO THEY COULD BE PEOPLE THAT ACTUALLY ARE ACCESSING THE RESOURCE TO DO NOT JUST RESEARCH BUT THEY COULD BE ALSO PEOPLE THAT ARE GOING TO ACCESS THE RESOURCE FOR THE OTHER AGENDA, OR IT COULD BE EVEN COMPANIES AND ORGANIZINGZATIONS THAT HAVE A RESOURCE, DATA ABOUT THEIR CREPT USERS AND THEY CAN USE THIS RESOURCE TO ENRICH THE DATA SET TO FIND MORE THINGS OUT ABOUT THEIR USERS. SO THAT'S WHY -- OKAY, SORRY ABOUT THAT. THIS GIVES US A LOT OF CERTAINTY IN WHAT WE KNOW ABOUT THE DATA USERS AND BECAUSE OF THIS UNCERTAINTY, WE WORRIED A LOT ABOUT WHAT THEY CAN DO WITH THE RESEARCH AND THAT IS WHY WE'RE DOING A LOT OF PRIVACY RISK ASSESSMENT AND ONE OF THE MOST IMPORTANT PRIVACY RISKS THAT WE ARE FOCUSING ON IS THE REIDENTIFICATION RISK AND WHY IS THE REIDENTIFICATION RISK SO IMPORTANT? I THINK IT IS ESSENTIAL EVEN THOUGH IT IS IN THE 1995, LIKE 30 YEARS AGO, WHEN COMPANIES LIKE THIS ONE, THE MASSACHUSETTS INSURANCE COMMISSION, THE COMPANIES LIKE THIS ARE STARTING TO SHARE USER HOSPITAL DATA TO THE RESEARCHER FOR RESEARCH PURPOSES. AND THEY ARE SAYING THE DATA SET IS TO BE IDENTIFIED AND THE THINGS IN THE CIRCLE ARE THE THINGS IN THE DATA SET. SO LATANYA SWEENEY DID THE DATA SET IDENTIFICATION. IF YOU KNOW SOMEONE'S ZIP CODE AND THE DATA AGENDA, LIKE THE AREA WHICH HAS SAY 20,000 PEOPLE AND THEN THE AVERAGE PERSON OF 80 YEARS AND A YEAR HAS 365 DAYS AND YOU WILL SEE THAT THE THREE THINGS ADDED TOGETHER CAN HAVE A GREAT CHANCE TO MAKE SOMEONE UNIQUE, LIKE YOU WILL BE UNIQUELY AID IDENTIFIED SOMEWHAT. SO THAT IS WHAT HAPPENED TO WILLIAM WELD, A HIGH PRETTY FILE PERSON IN THE DATA SET AND HIS INFORMATION GOT QUALIFIED BECAUSE HE IS THE ONLY PERSON WHO HAD HIS ZIP CODE, DATE OF BIRTH AND SEX ETHNICITY IN THE DATA SET. SO FIRST OF ALL, BEFORE WE GO INTO EACH CLASS OF THE DATA SET, THERE ARE OTHER THINGS THAT WE DID FIRST TO REDUCE THE RISK OF PILOTING. SO ALL THE FREE TEXT, I REMOVED. AND ALL THE DATES, I SHIFT BASED ON COMMON PRACTICE. OTHER DATES ARE SHIFTED IN THE BACKLOG TO RANDOM NUMBERS. IN A YEAR, A RANDOM NUMBER, 1 TO 365 DAYS AND ALL THE GEOLOCATION INFORMATION, SMALLER THAN A U.S. STATE. AND THEN WE ALSO REMOVED ALL THE PARTICIPANTS THAT ARE ABOUT 89 YEARS OLD. AND THEN WE LOOKED AT -- SO WE LOOKED AT EACH SECTION TO SEE THE THINGS THAT LEAD US TO SOMEONE'S IDENTITY SO WE WILL JUST GO THROUGH THIS TOGETHER SO SEE THE INTERESTING THINGS IN THE DATA SET, WHAT SOMEONE ELSE COULD KNOW ABOUT YOU FROM INFORMATION ON THE INTERNET AND FEED IT BACK TO GET TO KNOW YOUR IDENTITY. SO THE PHYSICAL MEASUREMENT. SOME OF THE THINGS ARE LIKE REALLY FAR-FETCHED WAYS TO IDENTIFY SOMEONE BUT THERE IS SOME INFORMATION LIKE WITH BODY TYPE AND BODY WEIGHT COULD ACTUALLY -- YOU COULD ALERT SOMEONE WITH ACTIVATION ON BODY HEIGHT AND BODY WEIGHT AND THEN THE RECORD INFORMATION WITHOUT VIOLATION FOR MORE INFORMATION? THE PROBLEM WITH THIS IS THAT THE CHANCE YOU WILL MEET ONE OF THE PARTICIPANTS AND DO THIS ESTIMATION IS NOT THAT GREAT AND ALSO THERE IS INACCURACY IN IT SO WE THINK IT IS NOT THAT FAVORABLE TO DO THIS TIME OF IDENTIFICATION ESPECIALLY ON A LARGE SCALE. SO THEN WE LOOK AT DRUGS AND THERE OR TWO WAYS THAT DRUGS COULD POSSIBLY LINK TO SOMEONE'S IDENTITY. LIKE IF SOMEONE TALKS ABOUT THE DRUGS THEY ARE -- THE MEDICINE THEY ARE TAKING, LIKE ON A PATIENT FORUM OR IF THEY DON'T -- IF SOMEONE OOZE WHAT THEY ARE TAKING TO LINK TO A MEDICAL COMMISSION AND IF THE ATTACKER KNOWS THAT A PERSON HAS A CERTAIN MEDICAL CONDITION, ESPECIALLY IF IT IS A RARE CONDITION, IT COULD BE POSSIBLE. BUT STILL, IF WE ADD THIS TO OUR PROTECTION MECHANISM, IT MEANS WE WOULD HAVE TO GO THROUGH ALL THESE DRUGS AND FIND OUT THE ONES THAT CAN LEAD TO THE REIDENTIFICATION AND THAT IS -- WOULD NEED MAYBE IN THE FUTURE TO DEVELOP TOOLS FOR THIS. WE ARE TAKING ALL THIS INFORMATION, AND ALSO SIMILARLY, HOSPITAL VISIT AND MEDICAL PROCEDURES. AND THESE ARE MEDICAL PROCEDURES AND THESE ARE THE DIAGNOSIS CODE. SO IN THE LITERATURE, IT HAS BEEN DEMONSTRATED THAT SOME OF THE DYING CODES CAN LINK TO IDENTIFICATION OF EVENTS AND ACTUALLY USEIC USING THIS DIAGNOSIS CODE CAN LINK BEAM A NEW STORY THAT ACTUALLY REPORTS THIS EVENT. SO WE FIND OUT THE CODES, REPORTABLE EVENTS AND REMOVE ALL OF THEM BEFORE WE MAKE THE DATA VAILABLE TO WHAT YOU SEE HERE. AND THEN ALSO WE DO MORE THAN A DIAGNOSIS PROBE THAT SUGGEST THE CAUSE OF DEATH SO FOR SOME DEATHS, IT IS ARBITRARY IN THE CODED INFORMATION BUT WE MAY LOOK INTO THE DEATH CAUSE FURTHER TO SEE IF THERE IS LIKE SOME INFORMATION WE CAN KICK OUT AND IF THIS IS THE MAIN REASON WHY THIS PERSON DIES, THE IMMEDIATE REASON WHY THEY DIED, WE ARE LOOKING INTO THIS FURTHER. AND THEN THE MAJOR ISSUES IS WITH THE DATA FROM THE SURVEY AND THE OTHER DATA FROM THE TRIAL. THIS IS THE DATA, LIKE RACE, ETHNICITY ORIENTATION, THE MEDICAL AND FAMILY HISTORY, THE OTHER DATA FROM HERE IS SIMILAR TO THIS ONE, SIMILAR TO THE SURVEY. IT HAS RACE ETHNICITY AND OTHER THINGS THAT CAN RELATE TO THE DATA CLUSTERS. SO FOR THESE TWO CLUSTERS, WE DID SOME CLUSTERS OF DATA AND GROUP THEM WITH LIFESTYLE, FAMILY HISTORY AND MEDICAL HISTORY AND THEN WE DID A QUANTITATIVE ANALYSIS TO LOOK INTO THE AVAILABILITY OF THE OTHER DATA SETS ON THE INTERNET AND WE FIND DEMOGRAPHICS, MEDICAL AND FAMILY HISTORY COULD BE MORE AVAILABLE ON THE INTERNET. THEN WE FURTHER DID QUANTITATIVE ANALYSIS ON THE DEMOGRAPHICS, THE MEDICAL HISTORY AND FAMILY HISTORY AND SO THE WAY WE DO THE QUANTITATIVE ANALYSIS IS THAT WE SIMULATE A LOT OF REASONABLE ATTACKERS THAT ARE DIFFERENT THAN THE INFORMATION THAT WE KNOW AND THEN WE LOOK -- WE CHECK IF THE ATTACKER KNOWS EACH SET OF INFORMATION, WHAT IS THE PROBABILITY AND THE EXPERIENCE THAT HAVE GOING TO BE UNIQUE AND REIDENTIFIED. AND THEN IF YOU ARE WONDERING HOW UNIQUE YOU ARE IN THE DATA SET, THE MORE WAYS YOU ARE -- IT IS NOT JUST THE UNIQUE, IT IS ALSO WHAT MAKES YOU UNIQUE AND THE MORE DIFFERENT COMBINATIONS OF THINGS THAT MAKE YOU UNIQUE, THE MORE RISK YOU WOULD BE. SO THIS IS MY INFORMATION FROM MY OFFICE AND FROM TENNESSEE, A GROUP OF 1600 PEOPLE AND THEN MY YEAR BOOK, 26 PEOPLE AND GOING OUTSIDE OF THE U.S. WHICH PUT ME IN 5 PEOPLE BUT I CAN NEITHER CONFIRM NOR DENY WHETHER OR NOT I AM A PARTICIPANT. [LAUGHTER] SO THAT IS FOR INDIVIDUALS AND FOR THE WHOLE DATA SET, WE LOOK AT HOW MANY OF THE NUMBER OF PERCENTAGE OF PEOPLE THAT ARE IN DIFFERENT GROUP SIZES USING A DIFFERENT SET OF INFORMATION AND THIS IS JUST AN EXAMPLE. IF WE HAVE ALL OF THIS INFORMATION IN THE CIRCLE HERE BUT INCLUDING RACE, ETHNICITY AND SOME OF THE THINGS LIKE EDUCATION, EMPLOYMENT AND BIRTH YEAR, WE WILL HAVE THREE PERSONS IN THE TABLE THAT ARE UNIQUE BUT THREE PERSONS, WE HAVE CURRENTLY 220,000 PEOPLE SO UNIQUE IS AROUND 5000 PEOPLE AND 1 PERCENT WILL BE IN GROUPS LESS THAN OR EQUAL TO 5. SO BASED ON THIS ANALYSIS ON DIFFERENT COMBINATIONS OF DATA FIELDS, WE CURRENTLY MADE THESE CHANGES TO THE -- MADE SOME GENERALIZATIONS TO SOME OF THE DEMOGRAPHIC INFORMATION. SO WE WILL SEE THE DETAILS WAS CHANGES WE MADE IN THE HANDOUT THAT YOU HAVE LATER TODAY AND SO BUT THE THINGS WE ARE THE MOST CONCERNED ABOUT, I HAVE A LITTLE BIT OF THINGS THAT I AM MOSTLY CONCERNED ABOUT, SO WE DID SOME GENERALIZATION TO THE RISK FACTOR OF CITY GROUPS SO IF YOU ARE IN AMERICA, INDIAN, ALASKAN NATIVE, HAWAIIAN NATIVE OR OTHER PACIFIC ISLANDER, AND NONE OF THESE GRABBED ME, YOU WILL BE ALL IN THE LATTER SCOPE OR IF YOU ARE SELECTED IN THE MULTIPLE FACTORS, YOU WILL BE IN TWO OR MORE RACES BUT THE HISPANIC AND LATINO, THIS WILL BE THE INFORMATION GROUP THAT WILL BE IN HERE. AND BECAUSE THEY SOMETIMES CONFLICT WITH EACH OTHER, WE REMOVED THE RACE ETHNICITY FROM THIS AND THEN WE ENTERED THE SEXUAL ORIENTATION TO ONLY HAVE THE MAIN GROUPS SO ANYONE IN THE MINORITY GROUP WILL BE GENERALIZED TOGETHER. ALSO THERE IS A DIAGNOSIS CODE AND DIAGNOSIS CODES CAN SUGGEST THE AGENDA OF THE SEXUALITY AND SO WE WENT BACK AND REMOVED THEM. SO FOR THE OTHER DEMOGRAPHICS, WE KEEP AUTOMATIC DATA AND TRIED TO GENERALIZE, EDUCATION LEVEL WHICH IS VERY SPECIFIC FROM KINDERGARTEN TO 4TH GRADE AND 4TH GRADE TO 7TH GRADE AND DID SOME ORIENTATION TO IT AND THEN REMOVED THE ACTIVE DATA SO WHEN THE RESOURCE GOES, WE WILL KEEP USING OUR TOOLS TO MONITOR RISK AND IF THE NUMBER OF OVERALL PARTICIPANTS INCREASE AND THE RISK BECOMES LOWER, THEN WE COULD POSSIBLY ADD MORE DATA TO IT OR MAKE IT LESS -- MAKE SOME OF THE ETHNICITY LESS GENERAL IN THE FUTURE. >> THANKS, WEIYI. WE'RE RUNNING LOW IN TIME BUT SINCE SHE TALKED A LOT ABOUT THE GENERALIZATION AND AUTHORIZATION OF THE DATA AND SOME OF THE CATEGORIES THERE FALL WITHIN THE AREA OF INTEREST IN PARTICULAR TO THIS GROUP, I WANTED TO GIVE A QUICK GLIMPSE OF WHAT IS COMING IN TERMS OF CONTROL AND NEW DATA ELEMENTS THAT MIGHT BE OF PARTICULAR INTEREST TO THIS GROUP. SO AS I MENTIONED, THE CONTROL HERE IS THE NEXT TIER OF DATA THAT HAS ADDITIONAL REGISTRATION REQUIREMENTS IN ADDITION TO THE REGISTERED HERE. WE'RE THINKING HERE INITIALLY THEY WILL NEED TO SIGN OFF AND THERE ARE ADDITIONAL REQUIREMENTS WE'RE WORKING THROUGH BUT THE CONTROL GROUPS WILL MOST LIKELY HAVE MORE DATA TYPES WITH MORE GRANULARITY OF WHAT COULD BE IN THERE AND THEN LOOKING AT OTHER CATEGORIES THAT MIGHT BE OF PARTICULAR INTEREST FOR SOME SPECIFIC KINDS OF USERS. AND THEN YOU WILL HEAR A LOT MORE ABOUT WHAT IS COMING IN TERMS OF NEW DATA WE WILL MAP IN THE NEXT TALK BUT I JUST WANTED TO LEAVE YOU WITH SORT OF A REALLY BIG OVERVIEW OF THE TYPES, GENOMIC DATA, LINKAGE TO DEATH DATA OR REGISTRY THAT WE'RE HOPING TO BRING IN IN THE NEXT YEAR AND THEN OF COURSE IN THE LONG RUN, TO BE ABLE TO ACCESS BY COURT OR OTHER ACCESSIBLE ACCESS AS WELL. AND WITH THAT, THANK YOU VERY MUCH FOR YOUR TIME. [APPLAUSE] >> SO WE CAN TAKE TWO QUESTIONS. >> HI, IS THIS ON? I AM CONCERNED A LITTLE ABOUT THE GENERALIZATION AND WONDER IF ANYBODY HAS DONE ANY MODELS OF JUST TRYING TO TRACE WHAT THE EFFECT THAT WILL HAVE ON THE RESEARCH? LIKE, YOU KNOW, WILL PEOPLE IN THE REGISTERED TIER BE ABLE TO DO ANY UBR RESEARCH WITH THESE KIND OF GENERALZATIONS AT ALL OR IS THERE DANGER THAT THEY MIGHT DRAW CONCLUSIONS THAT ARE ACTUALLY COMPLETELY WRONG? AND THEN, YOU KNOW, AT WHAT THRESHOLD CAN YOU START RELEASING THAT DATA IN TERMS OF THE GROSS NUMBERS OF THE MILLION ENROLLED? TO THAT IS A GREAT QUESTION AND THAT IS SOMETHING THAT WE HAVE BEEN THINKING ABOUT AND DISCUSSING INTERNALLY AT LENGTH WITHIN THE PROGRAMS IN TERMS OF THE IMPACTS ON THE RESEARCH INCLUDING UNDER REPRESENTED POPULATIONS IN BIOMEDICAL RESEARCH, AND THERE ARE, AS YOU POINTED OUT, QUITE A BIT OF LIMITATIONS IN TERMS OF WHAT CAN BE DONE WITH THE DATA BUT THERE ARE DATA -- THERE ARE RESEARCH IN THE REALM OF SPECIFIC DISEASE TYPES THAT CAPTURE THE UNDER RESEARCHED POPULATIONS THAT CAN BE DONE. OUR HORIZON FOR THE PROGRAM IS THAT WE MEET THE CONTROLS HERE AVAILABLE AS SOON AS POSSIBLE SO THAT RESEARCH OF THE TIME THAT CANNOT BE DONE IN THE REGISTER HERE CAN ACTUALLY BE DONE IN THE CONTROLLED TIER AND IN THE LONG SPAN OF TIME FOR THE PROGRAM, THAT DOES NOT REALLY REPRESENT A BIG SETBACK FOR RESEARCHERS WHO ARE INTERESTED IN THAT AND THAT DOESN'T ACTUALLY DESCRIBE PEOPLE DOING THE RESEARCH AND ENABLE TO DRAW WRONG CONCLUSIONS BUT THAT IS SOMETHING WE HAVE BEEN THINKING ABOUT VERY CAREFULLY TO MAKE SURE WE'RE COGNIZANT OF THOSE KINDS OF OF EFFECTS. >> I WAS WONDERING HOW LINKING THE DATA CHANGES THE OVERALL LANDSCAPE AND THEN THE CHARACTERIZATION RISK OF IDENTIFICATION RISK AND -- [INDISCERNIBLE] >> SO THAT'S A REALLY GREAT QUESTION AND IN TERMS OF NEW DATA SETS THAT ARE GOING TO BE LINKED TO THE RESOURCE, THE IDEA IS THAT AS NEW DATA TYPES BECOME AVAILABLE AND GET LINKED, WE WOULD ACTUALLY EXPAND THE RISK ANALYSIS AND THINGS DONE WITH THE DATA TO TAKE INTO ACCOUNT THE AIDED RISK THAT DATA PROVIDES WHEN IT BECOMES AVAILABLE. AND THEN WITH REGARD TO OTHER RISKS INHERENT, OF COURSE THERE ARE SECURITY RISKS AND THINGS LIKE THAT THAT ARE REALLY IMPORTANT TO CONSIDER AS WELL AND WHILE WE FOCUSED TODAY A LOT ON PRIVACY, THERE ARE SEPARATE GROUPS WITHIN THE PROGRAM THAT ARE WORKING TO ASSESS AND MAKE SURE THE SECURITY RISKS ARE MITIGATED AND THE RIGHT SAFEGUARDS ARE IN PLACE TO INSURE THERE ARE NO OTHER RISKS LIKE THAT. COMMENT -- IS THIS THE TIME OR WILL IT BE LATER? >> QUICK COMMENT. >> I JUST WONDER HAVING QUALITATIVE STUDIES THAT EXPRESS THE CONCERNS OF THE COMMUNITIES FOR ABR FOR ANY OF US WHO ARE PART OF THIS PROJECT, WE HAVE A LOT OF KNOCKOUT EVIDENCE OF WHAT ARE THE MAIN CONCERNS AND YES, PRIVACY IS ONE OF THEM BUT THE WAY WE CONSTRUE BASIC PRIVACY, I FEEL SOMETIMES REFLECTS ON HOW I ACCESS MY COMMUNITY. SO IN THE WORKSHOP, THE FIRST PROPOSAL WILL BE LET' REALLY HEAR REALS REALLY HEAR FROM THE COMMUNITIES FROM THAT ASPECT. >> SO JOIN ME BY WELL WELCOMING TWO MORE PEOPLE ON THE STAGE, WE HAVE JOHN WILL BANKS, SAGE BIONETWORKS AND ERICKA THOMAS FROM ALL OF US RESEARCH. >> THANKS, EVERYBODY, I WILL RUN THROUGH A LITTLE BIT ON SORT OF THE STRUCTURE OF THE PROTOCOL. YOU HAVE HEARD A LOT OF THE CONTENT OF THE PROTOCOL BUT BECAUSE WE'RE GOING TO ADAPT IT TO THE OUTCOMES OF THIS WORKSHOP, I THOUGHT IT MIGHT BE USEFUL TO SEE HOW IT WORKS ON A STRUCTURAL LEVEL. I WILL GO THROUGH THE CONSENT PROCESS AND SHOW A BIT OF DATA WE HAVE ON NUMBERS COMING OUT OF THAT AND THEN HAND IT OVER TO ERICKA WHO CAN WALK THROUGH THE POLICY ASPECT. SO THAT IS WHAT WIRE' GOING TO TRY TO ACCESS IN THE ELEMENTS AND WHAT IS POSSIBLE GOING FORWARD. I WANT TO START BY ACKNOWLEDGING THE SAGE NETWORKS TEAM, I HAVE THREE COLLEAGUES OVER THERE, TORI, SAGA AND MEGAN BUT THIS INVOLVES ARE LARGE AND GROWING TEAM IN SEATTLE. SO I PULLED THIS FROM THE PROTOCOL AVAILABLE AT THE URL BELOW THAT IS A STABLE LINK I HAD FOR A COUPLE OF YEARS THAT WILL LET YOU GET TO THE PROTOCOL AT SOME POINT, YOU CAN DIG THROUGH AND SEE ALL THE VIDEOS AND DOCUMENT AT YOUR LEISURE SO YOU KNOW BUT THE REASON I RAISE THIS IS TO INDICATE THE COMPLEXITY OF THE PROTOCOL JUST AT A STRUCTURAL LEVEL. WE HAD A SINGLE NATIONAL INDEPENDENT IRB WHICH WE HAVE AARON IN THE BACK, GOLDENBERG AND I DON'T KNOW IF WE HAVE ANY OTHER MEMBERS HERE, THIS IS COMPLICATED TO WRITE AND SUBMIT AS A DOCUMENT. IT HAS MORE IN COMMON WITH SOFTWARE, TEXTURES THAN IT DOES A SIMPLE WORD DOCUMENT. WE HAVE TO CORRECT FOR ALL THE VOLUNTEER EFFORTS THAT STEPHANIE OUTLINED, THE DATA RESEARCH CORE, THE PARTICIPANT TECHNOLOGY CENTER, THE SERVICE CENTER, BIOBANK, ALL THE PROVIDER ORGANIZATIONS, 348 SITE THAT ARE PHYSICALLY ENROLLING PARTICIPANT, THERE IS A LOT OF DETAIL AND WE HAVE HAD TO MAKE A LOT OF CHOICES ABOUT WHAT IS IN THE CORE PROTOCOL, HOW DO WE STRUCTURE AND ORGANIZE THIS SO THAT THE PROGRAM WORKS AS MUCH AS POSSIBLE AND YOU WILL SEE THAT REFLECTED IF YOU CAN THROUGH AND READ THE ACTUALLY DOCUMENT. BUT THE MOST IMPORTANT PART PROBABLY FOR TODAY IS THE MENTAL MODEL WHICH IS THAT WE TRIED TO KEEP TO AN 80-20 PRINCIPLE OR WE HAVE A NATIONAL CORE PROTOCOL THAT MAINTAINS THE ELEMENTS OF THE PROTOCOL THAT ARE CONSISTENT ACROSS ALL OF THE VARIOUS STAKEHOLDERS AND THEN WE HAVE THE INDIVIDUAL SITES OR AWARDEES WHO CAN WRITE SPECIFIC AMENDMENTS THAT INDICATE HOW THEY ARE DIFFERING FROM THE CORE PROTOCOL OR DIFFERENT VARIATIONS ON THE CORE PROTOCOL SO WE CAN ATTRACT THIS AND WHAT THIS DOES IS CREATE SEPARATION OF CONCERNS, AN INTERCEPT PRINCIPLE AND THE IDEA IS THESE ELEMENTS MEAN IF WE HAVE AN ERROR OR A PROBLEM IN A SITE-SPEAK SPECIFIC CONTEXT, WHILE WE FIX THAT, IT DOESN'T AFFECT THE REST OF THE PROTOCOL. SO SORT OF LIKE WITH SOFTWARE, BY HAVING THESE STANDALONE ELEMENTS, WE CAN CHASE DOWN AND ISOLATE BUGS BEFORE THEY SPREAD. IT ALSO MEANS WE CAN TAKE THE LARGE CHUNKS LIKE THE DRC THAT YOU JUST HEARD FROM AND MAKE SURE THEY HAVE A PROTOCOL ELEMENT THAT IS VERY RESPONSIVE TO THEIR NEEDS. SO OVER TIME WHEN WE GET THINGS LIKE THE SCIENCE COMMITTEE THAT KELLY TALKED ABOUT, WE CAN PLUG THOSE INTO THE ELEMENTS OF THE SOFTWARE WHERE IT BECOMES POSSIBLE SO WE CAN INTEGRATE THEM IN THE OPERATING SYSTEM GOING FORWARD AND THEN AS BEST PRACTICE EMERGE, WE CAN ADD THOSE TO THE PROTOCOL SO IF SOMETHING IS APPROVED BY THE IRB AT A SITE, ADD THE PROTOCOL AND ALL THOSE SITES CAN START USING THE MATERIAL OVER TIME. THIS IS HOW IT WORKS MENTALLY, NOT INTUITIVE WHICH IS NOT HOW MOST STUDIES WORK BUT MOST DON'T HAVE THE KIND OF ARCHITECTURE AND IRB SYSTEM THAT WE HAVE SO THIS IS HOW IT WORKS. THIS IS MAINLY FOR TORI AND SARAH AND WE HAVE TO TRACK ALL THE INFORMATION ACCESSIBLE BY AWARDEES, THESE ARE THE KINDS OF THINGS THAT START TO BE POSSIBLE WHEN YOU THINK ABOUT SOMETHING THAT IS A TRADITIONALLY A GOVERNANCE JOB AS A SOFTWARE JOB AND THIS STARTS TO MOVE INTO THE KINDS OF QUESTIONS YOU THINK ABOUT, LIKE HOW LONG DOES IT TAKE TO GET SOMETHING APPROVED? IT IS AN INTERESTING GOVERNANCE PROGRAM THAT CAN HELP US UNDERSTAND HOW THESE TYPE OF PROGRAMS MIGHT BE SIMILAR SIMILARLY USED BY OTHER PROGRAMS. SO THESE KINDS OF THINGS SHOULD NOT BE OPAQUE AS MOST TRADITIONAL COMMUNICATIONS ARE WITH REVIEW BOARDS, THAT THEY SHOULD BE FAR MORE TRANSPARENT AND ARE AVAILABLE. SO NOW TO GET MORE INTO WHAT WE HAVE DONE AND THIS IS M EGHAN DOERR'S WORK, HOW DOES THE INFORMATION INTEGRATE SO WE CAN MAKE AVAILABLE WHAT PEOPLE WANT TO KNOW ABOUT. I WILL WON'T READ THIS BUT I WILL CALL ON MY FAVORITE CIRCLE WHICH IS WHAT ARE YOU NOT TELLING ME? PEOPLE WANT TO KNOW WHAT YOU ARE NOT TELLING THEM AND THIS IS BOTH A REACTION TO CONSENT OUTSIDE OF THIS PROGRAM, WITH THE SIMPLE CONTEXT WITHIN THE TECHNOLOGY LEVEL BUT WHAT WE ARE ATTEMPTING TO ENROLL SO THIS IS SOMETHING WE TAKE SERIOUSLY AT SAGE TO MAKE SURE THERE IS NOTHING THAT IS IMPORTANT THAT WE'RE NOT TELLING PEOPLE. AND I LOVE THIS ALSO. THE KINDS OF WORDS THAT DO OR DON'T MAKE SENSE TO PEOPLE WHICH IS NOT WHAT WE MIGHT HAVE THOUGHT GOING IN. PEOPLE AT CSI HAVE A DIFFERENT IDEA WHAT HAVE DNA MEANS BUT THEN BIOMARKER IS A SHORTHAND WE USE THAT PEOPLE DON'T UNDERSTAND, AND SO WE HAVE TO TRY TO AVOID THESE WORDS. THIS IS THE F-SHAPED READING PATTERN, IT IS FROM EYE GAZE FIXATION TRACKING AND POST PEOPLE WHEN THEY ATTEMPT TO READ ON SCREENS, DON'T. THEY SCAN. AS WE SCAN DOWN, WE READ LESS AND LESS AND LESS AND THIS IS A DESIGN CHALLENGE WHICH MEANS EVEN IF WE PUT THE CONSENT FORM ON THE SCREEN AT THE BEST POSSIBLE READING LEVEL WITH THE INFORMATION THAT PEOPLE TO WANT READ, THEY WILL PHYSICALLY NOT READ IT. WORSE, SURVEYS INDICATE THEY BELIEF THE HAVE READ THE WHOLE DOCUMENT. THIS IS MY POLITICAL JOKE MOMENT BUT THIS IS REALLY IMPORTANT FROM AN INFORMED CONSENT PERSPECTIVE BECAUSE PEOPLE DON'T READ PHYSICALLY THAN WE THINK THEY WILL. THE SECOND IS CULTURAL, NOT CONTEXTUAL, WE ARE ACCUSTOMED TO CLICKING ON "OKAY" THAT LEADS US TO ANOTHER SCREEN. WE JUST CLICK OKAY AND THERE IS ANY NUMBER OF STUDIES THAT ARE CONFIRMED THAT PEOPLE WILL GIVE AWAY THEIR FIRST-BORN CHILD, SIGN UP FOR 100,000 HOURS OF COMMUNITY SERVICE AS WELL AS ACCESS TO A PUBLIC WI-FI NETWORK. SO AS WE DESIGN THIS ECOCONSENT, WE GET INTO THAT ENVIRONMENT. WE HAVE TO SLOW PEOPLE DOWN TO THE SAME SPEED OF READING AND FORCE THEM TO ENGAGE WITH THE CONTENT BECAUSE OTHERWISE THEY WON'T. THIS IS A FEATURE, NOT A BUG TO CONSUMER TECHNOLOGY COMPANIES BUT SOMETHING WE TAKE VERY SERIOUSLY IN THE PROGRAM. AND ALL OF THIS ROLLS UP INTO A DESIGN PROBLEM BECAUSE E-CONSENT IS NOT SORT OF AN INSTITUTIONAL PROCESS LIKE REGULAR INFORMED CONSENT IN MANY CONTEXTS. IT EXISTS IN A HEAVILY-DESIGNED ENVIRONMENT. EVERY CLICK OR TWEAK ON A PHONE HAS BEEN DESIGNED TO BE AS FRICTIONLESS AS POSSIBLE WHICH IS THE GOAL AND THAT IS WHY IT IS TOO FRICTIONY TO GO TO AMAZON AND BUY TIES SO THEY WILL SEND OUT A BUTTON THAT WILL AUTOMATICALLY BUY YOUR TIDE. SO HOW DO WE USE QUANTITATIVE AND QUALITATIVE METHODS TO SLOW PEOPLE DON'T AND FORCE THEM TO GIVE CONSENT IN THE NETWORK? SO THIS WAS HOW WE STARTED SEVERAL YEARS AGO, BREAKING INFORMATION INTO A SERIES OF SCREENS, REPRESENTING THE LONG-TERM DOCUMENT, THE INTERFACE IN FRONT OF AND WE FOUND THE PICTURE HEADLINE WOULD SLOW DOWN EYE GAZE TRACKING FROM SPEED TO PRINT. WE INCLUDE ANIMATION VIDEOS IN THE ICON SPLIT. FROM THE BEGINNING, WE HAVE INCLUDED AN ASSESSMENT OR QUIZ. SOMETIMES THAT IS CALLED SUMMITED WHEN MEANS YOU HAVE TO GET THEM ALL CORRECT GOING FORWARD. WE HAVE ANOTHER TEACHING ELEMENT THAT WE INCLUDE HERE IN THE FORMATIVE ASSESSMENT AND IT ALSO RECOGNIZES IT IN E-CONSENT, ONE OF THREE DOCUMENT THAT ACTUALLY GOVERNS. SO THERE IS THE INTERACTION PROCESS, THE DOCUMENT YOU SIGN AND THE PRIVACY POLICY AS FAR AS SERVICE ACCESS GOVERN THE USER BECAUSE THEY GOVERN THE SOFTWARE YOU HAVE GOT. WE HAVE USED THIS WITH THE APPLE RESEARCH KIT, WIDELY ADOPTED. AT SAGE, WE HAVE 33 OTHERS THAT LEVERAGE THIS KIND OF PROCESS AND HOW WE END UP BEING AWARDED IN THE PROGRAM. BUT ALL OF US THAT VERY SIMPLE AT-RISK STUDIES AND ARE INDULGED TO COME UP WITH A SINGLE NATIONAL CONSENT. CHER HELPED WORK ON THE 50-STATE AND TERRITORY ANALYSIS TO MAKE SURE WE'RE COMPLIANT THERE. IT HAS TO WORK FOR IN-HOME AND IN-PERSON COMPLETION BASED ON WHAT STEPHANIE AND OTHERS HAD IT TOLL YOU TODAY. IT OUGHT TO BE FOR WELL OVER A MILLION AND AS TRANSPARENT AS POSSIBLE. RATHER THAN HAVING ICONS, WE HAVE VIDEOS. THAT IS BECAUSE THE 48-PERSON WORKING GROUP THAT MEGHAN LED FELT LIKE HIDING INFORMATION IN A LAYER TO MAKE IT MORE COMPREHENSIBLE WOULDN'T BE COMPANY PLIANT -- -- BE COMPLIANT WITH THE REG. SO IT ALLOWS US TO INCLUDE A VOICE REGULATION AND CLOSED CAPTIONS OVER THE VIDEOS FOR PEOPLE WHEN AUDITORY DIFFICULTIES. THEN WE HAVE THE HIPAA CONSENT, AUTHORIZATION OF OTHERS AS NEEDED AND OTHER TYPES OF CONSULT COMING DOWN THE PIKE. WE HAVE THE WIKI WHERE WE FLUSH TO CREATE NORMS TO THINK ABOUT READING LEVEL WHICH TOOK A WHILE BUT IT HAS WORKED. SAME FOR THE HIPAA AUTHORIZATION, LOT OF WHITE SPACE, NO LARGE-CAP WHICH IS COMMON AND THEN WE CAN MANAGE THE DATA ON THIS. THIS IS A SCREEN SHOT OF THE GOOGLE ANALYTICS AND YOU CAN SEE MONTH BY MONTH, THE PEOPLE WHO ADMIT CONSENT, THE BOTTOM LINE, RESERVED CONSENT AND THE TIME OF THE VIDEO, THE TIME YOU CHOOSE YOUR STATE, ALL THE WAY TO THE VERY END AND IF YOU DO THIS IN FRONT OF THE LAUNCH DATE WHERE WE ARE AT 67 PERCENT OF PEOPLE WHO HAVE SIGNED AND COMPLETED ALL THE CONSENT FORMS. THE NUMBERS GET BETTER, THE MORE ANS LATER ITEMS YOU DROP OUT WHICH IS NOT PART OF THE CONSENT DOCUMENT BUT WHAT IS EXCITIG AGAIN FROM THE RESEARCH PERSPECTIVE, THIS IS QUESTION RABLE -- QUERY-ABLE DATA. WORKING WITH A 48-PERSON RESEARCH GROUP HAS NOT BEEN FUN AND WHAT IS GREAT FOR THIS DATA I AM GOING TO SHOW YOU IS GETTING THE DATA AND SEEING IT BECOME STABLE OVER TIME. SO THESE ARE THE QUIZ QUESTIONS, THE ASSESSMENT AND THESE ARE NOT MEASURES OF COMP HENS. A - COMPREHENSION. WE ARE HIGH IN THE 90 PERCENT RANGE AGGREGATE FOR PEOPLE WHO ENROLL IN THIS PROGRAM ON THIS QUESTION AND WE HAVE A VARIETY OF -- OF DEMOGRAPHICS, VOLUNTARINESS, CAN I WITHDRAW, THESE THE QUESTIONS WE GET MOST. WE DIDN'T WRITE THIS AT OUR OWN REQUIREMENTS AND IT DOESN'T GRADE AT THE 5TH-GRADE LEVEL LIKE OTHERS DO BUT ALSO SHOWS PRIVACY IS NOT A CONCEPT THAT IS CLEAR FOR LOTS OF PEOPLE IN THIS COUNTRY. THAT IS NOT NECESSARILY A BAD THING BUT THE REALITY IS THAT WE SEE A VERY DIFFERENT BATCH OF NUMBERS HERE ON THIS QUESTION. INTERESTINGLY, YOU CAN SEE THERE IS A BOLUS FROM HIGH SCHOOL TO 5TH GREATER WHERE WE HAVE THE NUMBERS WRONG. SO THE PEOPLE AT THE LOWER END OF THE SELF-EDUCATION PERSPECTIVE ARE MORE CURRENT BUT WHAT IS INTERESTING IS WE START TO SEE THESE FALL WITHIN AT INCOME CURVE AND THIS IS THE DATA WE DIG INTO. WHERE IS IT COMING FROM? THE USER DATA, THE PRIVACY CHANGING, THE DROPOFF RATES COMING FROM THE UX, SYMPTOMS OF AN INFORMED PROCESS THAT IS WORKING? BECAUSE SOMEONE WHO GOES THROUGH THIS PROCESS AND SAYS NO, THAT IS A SUCCESSFUL TRIP THROUGH THE CONSENT PROCESS EVEN IF IT DIDN'T RESULT IN AN ENROLLMENT. THESE ARE THE QUESTIONS I WOULD ENCOURAGE YOU TO START DIGGING INTO AND ENCOURAGE YOU TO GET INTO TODAY. SO WITH THAT I WILL TURN IT OVER TO ERICKA AND YOU HAVE 16 MINUTES, PLENTY OF TIME. [APPLAUSE] >> THANK YOU, JOHN, AND NOW WE WILL TURN TO POLICY IMPLEMENTATION. THE ALL OF US RESEARCH HAS IMPLEMENTATION FOR ACTING FEDERAL AND PRIVATE POLICY SHAPING THE LANDSCAPE OF THE FUTURE. WHILE MANY OF THESE ARE GOVERNED IN ALL RESEARCH PROGRAMS, WE HAVE THE CORE PROTOCOL AND RESEARCH ACTIVITIES. SO NOW LET'S DIVIDE THE TWO IN OUR PROGRAMS. THE POLICIES IN OUR PROGRAM ARE SHAPED BY MANY DIFFERENT ELEMENTS. THERE ARE FEDERAL AND STATE LAWS THAT APPLY FOR THE PROGRAM AND SHAPE DIRECTIONS. THERE ARE LAWS AND REGULATIONS THAT THE PROGRAM IS NOT OBLIGATED TO COME PLEA WITH, WHOLELY OR IN PART POLICY DECISIONS. THERE ARE SPECIFIC POLICIES AND GUIDANCE WRITTEN SPECIFICALLY TO SHAPE THE PROGRAM AND POLICY STAFF HAVE WITHIN THE PROGRAM AND THEN DEVELOP AS NEEDED TO FUND THE PROGRAM DEVELOPMENT. THE OVER ARCHING AND LEGAL FRAMEWORK IS THAT WITH FEDERAL LAWS AND REGULATIONS THAT GOVERN OUR EXPERIENCE AS WELL AS OUR PROCESS AND RETURN OF ELECTRONIC HEALTH RECORDS AND INFORMATION. LAWS AND REGULATIONS -- SORRY. LAWS AND REGULATIONS IN THE PROGRAM INCLUDE THE COMMON RULE, THE HEALTH SERVICE AND 20TH CENTURY CARES ACT WHICH WAS DRAFTED AND NEGOTIATED BY OUR VERY OWN POLICY DIRECTOR, HIPAA WHICH IS IN PRIVATE SECURITY ROLES AND ONLY APPLY IN CERTAIN CIRCUMSTANCE IN THIS PROGRAM AND THE LAWS AND REGULATIONS FROM THOSE 50 STATES, WASHINGTON D.C. AND THE FIVE POPULATION TERRITORIES AND INVOLVE PRIMARY CONSENT, AUTHORIZATION AND GENOMIC RESULTS. SO FOR EXAMPLE, AS A NATIONWIDE PROGRAM, OUR INFORMED CONSENT PROCESS MUST COMPLY WITH THE LAWS OF THE 50 STATES AND FIVE TERRITORIES. AND TO MEET THESE DEMANDS, WE SEE THAT THESE APPLY TO THE POLICY CHOICES. THE PARTICIPANTS MEETING REQUIREMENTS OF THE STATE IN WHICH THEY LIVE. THEN THERE ARE FEDERAL LAWS AND REGULATIONS -- SORRY, I ADVANCED THIS TOO FAST. THE LAWS AND REGULAR DAYS WHICH WE WERE ENCOURAGED TO APPLY. IN MOST CASES, WE HAVE MADE THE DECISION AS A PROGRAM TO ADOPT THESE OR TO CONSIDER THEM AS ASPECT OF PROGRAM POLICY. THIS PROVIDES A COMPREHENSIVE FRAMEWORK TO PROTECT THE GOVERNMENT INFORMATION ABOUT POTENTIAL OR MANMADE REQUIREMENT. THESE THEN FORM OTHER SECURITY POLICIES AND YOU CAN READ MORE ABOUT OUR SECURITY FRAMEWORK ON OUR WEBSITE. THE OTHER SET OF POLICIES, SO THE PRESIDENTIAL CHARGE, AN INTERAGENCY COMMITTEE WAS DEVELOPED TO HELP GUIDE THE PRINCIPLES FOR THE INITIATIVE NOW KNOWN AS A THE PMI TRUST PRINCIPLES AND DATA SECURITY PRINCIPLES AND FRAMEWORK. THE RESEARCH PROGRAM ADHERES TO BOTH THE PRIVACY AND TRUST PRINCIPLES AND DATA SECURITY FRAMEWORK AND SEEING ALL OF OUR CONSORTEES TO THE NECESSARY WORK, SUSTAINING RISKS. THE COLLABORATIVE NATURE OF THE DATA RESOURCES AND PROCESSES FOR DATA ACCESSING NEEDS. THE PRINCIPLES ARE ALSO USED AS A MODEL FOR OUR PROGRAM, A CORE VALUE AND IN THE CORE VALUES, I USE A EVERYDAY SITUATION. THE RESEARCH ETHICS TRAINING IS REQUIRED FOR ALL INDIVIDUALS REQUESTING ACCESS TO THE REGISTER AND THE CONTROL DATA SERIES. THE PRINCIPALS ALSO ARTICULATE THE OBJECTIVES FOR PARTICIPANT DATA, WE DON'T HAVE ANY MEMBERS OF OUR SECURITY TEAM IN THE ROOM BUT I AM HAPPY TO HELP YOU MAKE THAT CONNECTION FOR ANYONE IN THE ROOM WHO REQUIRES IT. THE NEXT SET OF POLICIES ARE DRAFTED BY THE GOVERNMENT BODY AND BECAUSE THIS IS A UNIQUE WAY TO ACCESS DATA, IT HAS A VERY GUIDED PROCESS TO STAY WITHIN THE RESOURCES AND OUR CONSORTIUM OFFICERS AS WELL AS COLLABORATOR. AND THEN INFORMING THE POLICIES TO IMPLEMENT DEVELOPMENT. FOR EXAMPLE, THE SCIENCE COMMUNITY PROVIDING FOR THE ALL OF US RESEARCH, THE DATA WE COLLECT, AN LIT ANALYTICAL TOOLS WE GO INTO USE WHICH KELLY SPOKE TO IN DETAIL EARLIER SO I WON'T GO FURTHER INTO THAT. CAPS IS CHARGED WITH PROTECTING OUR PRIVACY AND THE DATA AND INSURING THE TRUST WE BROKE IS MAINTAINED. >> IT DOES PROVIDE SOME DATA CHOICES ON THE RED-HOT BOXES ON THE SIDE. POLICIES LIKE THE DATA ACCESS FRAMEWORK WITH TRAFFIC DELIVERABLES OR A DATA AGREEMENT. IN TERMS, SOME OF THE REVIEW RESPONSIBILITIES CARRIED OUT BY THE LEAGUE Y'ALL ACCESS BOARD RESPONSIBLE FOR AGO GREATING THE DATA FOR POSSIBLE RESEARCH PROPOSALS. AND WE WILL TALK ABOUT A LITTLE MORE RESEARCH HERE, OUR LAST TYPES OF POLICIES ARE DERIVED FROM POLICIES THAT WERE NOT IMPLEMENTED IN OUR PROTOCOL AND THEY WILL FILL GAPS WITHIN OUR PROGRAM AS IT GOES AND IT MAY EVENTUALLY FIND ITS WAY INTO THE CORE PROTOCOL SO RIGHT NOW, WE DISSEMINATE THEM TO THE CONSORTIE, OUR WEBSITE.SO SOME OF OUR STANDALONE POLICIES INCLUDEUR -- MAYBE THEY ARE UP HERE? NO, THEY ARE NOT. SOME OF OR POLICY ARE THE FOLLOWING AND THIS IS NOT AN EXHAUSTIVE LIST BUT WE WILL CONTINUE TO DEVELOP THEM AS THE PROGRAM CONTINUES TO GROW. SO BACK TO STIGMATIZING RESEARCH, THIS WAS DEVELOPED BY A DOCTOR IN RESPONSE TO A NEED THAT CAPS HAD TO DEVELOPING PROGRAMMATIC RESEARCH. AND THIS IS IMPLEMENTED BY RAB THROUGH A REVIEW PROCESS. AND THAT IS IT. I WILL STOP THERE AND THANK YOU SO MUCH FOR YOUR TIME TODAY AND HAPPY TO TAKE QUESTIONS. [APPLAUSE] GENOMICS COLLECTIONS PHASE, ARE YOU INTENDING TO OFFER ANY ACCESS TO GENETIC COUNSELING THROUGH SAY ANY KIND OF DIGITAL PLATFORMS? >> YES, WE ARE IN THE PROCESS OF IDENTIFYING OUR GENETIC COUNSELING AND RESOURCE CENTER AND THEY WILL BE RETURNING THE RESULTS TO PARTICIPANTS. >> HI, I AM WONDERING ABOUT SORT OF THE EVOLUTION OF THIS PROCESS AS YOU GO FORWARD THINKING ABOUT LONGITUDINAL RESEARCH, DO PEOPLE GET RECONSENTED, THINGS ON A REGULAR SCHEDULE, THINKING ABOUT THINGS LIKE STIGMA AND RISK VERIFICATION, THINGS THAT WILL EVOLVE TO AFFECT WHAT PEOPLE ARE CONSENTING TOO, HOW DO YOU SEE THAT PROCESS GOING FORWARD? >> I WOULD ENCOURAGE MEGHAN WHO IS BEHIND YOU THERE TO TAKE THE MICROPHONE. >> SO HELLO, EVERYONE, IT GOES BEHIND THE POST AND I FEEL YOU. SO THE IDEA OF INFORMED CONSENT AS AN ONGOING -- TRUTHFULLY AN ONGOING MARITAL CONTRACT, RIGHT, THAT HAS A RENEWAL AND BALANCED PHASE IS SOMETHING THE PROGRAM IS REALLY WORKING TOWARDS SO WE COME BACK AND RECONNECT WITH PARTICIPANT OVER TIME AND THE NATURE OF THIS STUDY IS THAT IT WILL BE SO LONG AND SO MUCH THAT GETS ADDED TO IT IN TIME THAT WE WILL CONTINUE TO NEED THIS INFORMATION, WHETHER A FORMAL PROCESS THAT REQUIRES A SIGNATURE OR WHETHER WE DO MANY TYPES OF INTERACTION THAT REQUIRE ATTENTION BUT ARE NOT SIGNATORS, WE HAVEN'T DECIDED YET. AT THIS POINT WE'RE WALKING PEOPLE THROUGH THE CONSENT AND EVENTUALLY THE HIPAA RESULTS WILL REQUIRE A SEPARATE SIGNATURE AND THEN WE WILL START THINKING ABOUT HOW WE ENGAGE WITH THE PARTICIPANTS AS THE NEXT STEP. DOES THAT ANSWER YOUR QUESTION? GREAT, GO THANK YOU. >> MY QUESTION WAS ABOUT STIGMATIZING RESEARCH AND WHAT IF THE RESEARCH IS PUBLISHED WIDELY AND WIDELY IMPLEMENTED? I MEAN, I DON'T UNDERSTAND WHERE THE INTERVENTION AGAINST STIGMATIZING RESEARCH COMES INTO THIS. >> SO I THINK WE ACKNOWLEDGE A GOOD PORTION OF THIS HAPPENS AFTER IT LEAVES THE RESEARCHER'S HANDS AND THERE IS A LIMIT TO WHAT WE CAN DO ONCE THE CAT IS OUT OF THE BAG BUT THERE ARE THINGS WE CAN DO TO RAISE CONSCIOUSNESS PRIOR TO THE STUDY WITH THE RESEARCH AND THE RESEARCHERS THEMSELVES TO MAKE SURE IT IS NOT UTILIZED IN A WAY THAT IS UNINTENDED AND THERE IS A WAY WE CAN PENALIZE PEOPLE AFTER THE FACT SO IF THEY DO PUBLISH SOMETHING AND IT IS TRENDED INTO STIGMATIZATION, OR IF CAN CHANGE THE RESEARCH IN THE RESOURCE SO IT IS WORTH THINKING ABOUT ALL THE THINGS WE CAN DO UPFRONT AND AFTER THE FACT AND WHILE WE'RE LIMIT AFTER THE FACT, WE CAN DO SOME THINGS UPFRONT SO WE'RE FOCUSING ON THAT. [ OFF MIC ] OR EMPLOYERS OR COMPANIES THAT MAKE FITBIT AND ANY SPECIFIC I.T. POLICIES REGARDING ACCESS TO THE RESEARCH DATA? >> YOU WANT TO ANSWER THAT? >> OKAY, SO A MULTI-PART QUESTION. IN TERMS OF WHO GETS ACCESS, WE HAVE NO BOUNDS ON THAT. WE HAVE BEEN VERY CLEAR IN OUR PRIMARY CONSENT THAT THIS RESOURCE WILL BE OPEN TO AUTHORIZED USERS SO FOLKS WHO GO THROUGH THE PROCESS OF GAINING ACCESS AND IDENTIFYING THE TRAINING, WE ARE INTENDING FOR ACADEMIC RESEARCHERS, SCIENTISTS, FOLKS IN THE INDUSTRY TO ACCESS THE RESOURCE SO THERE IS NO DIFFERENCE IN POLICIES. AND THEN THE SECOND PART OF YOUR QUESTION WAS? >> WONDERING IF THERE WAS ANY SPECIAL I.T. POLICY? >> SO WE DON'T HAVE ANY SPECIAL INPOLICIES. -- I.P. POLICIES. >> FOLKS WHO ARE AUTHORIZED TO HANDLE THE RESEARCH ARE ABLE TO DO SO. >> WHAT ARE THE CONSEQUENCES FOR THE PEOPLE WHO VIOLATE THE DATA USE AGREEMENT? >> WELL, THAT IS SOMETHING THAT IS IN NEGOTIATION RIGHT NOW SINCE WE DON'T HAVE ANYONE ACCESSING THE DATA RIGHT NOW, IT IS STILL IN THE NEBULOUS PLANNING STAGES SO WE WILL GET BACK TO YOU ON THAT ONE. AND WITH THAT, I AM GOING TO LET YOU ALL OUT OF THIS ROOM FOR LUNCH. PLEASE BE BACK PROMPTLY AT 1:15. I KNOW WE'VE BEEN RUSHING A LITTLE BIT BECAUSE THERE'S SO MUCH INFORMATION WE WANTED TO COVER AND WE HAVE HAD TO CURTAIL OUR QUESTION SESSIONS A LITTLE BIT AND I WOULD LIKE TO--WE HAVE A LITTLE WIGGLE ROOM THIS AFTERNOON, I WOULD LIKE TO OPEN IT UP RIGHT NOW FOR 10 MINUTES OF QUESTIONS, IF YOU HAVE A BIG PICTURE OVERARCHING QUESTION FOR ANY OF THE SPEAKERS FROM THIS MORNING, IF YOU WANT TO STAND UP AT 1 OF THE MICs AND ASK, OR AGAIN RAISE YOUR HAND IF YOU CAN'T GET TO A MIC AND WE WILL BRING 1 TO YOU. SERIOUSLY? NO QUESTIONS. OH, WELL, FEEL FREE THIS IS THE PERFECT TIME TO ANSWER THOSE QUESTIONS. YES, PLEASE. SO IT'S A VERY INFORMATIVE MORNING AND I HAD A QUESTION ABOUT THE DE-IDENTIFYING OF DATA AND YOU SAID THAT YOU--OR 1 OF THE SPEAKERS SAID YOU WOULD BACK TRACK THE DATE BY 3 MONTHS, SO IF THAT'S PUBLIC KNOWLEDGE HOW WILL IT HELP PROTECT? >> IT'S VARIABLE SO IT'S CONNIVITIENT WITHIN THE PERSON BUT VARIABLE BETWEEN PEOPLE. >> GOT IT. THAT MAKES MORE SENSE OTHERWISE YOU'RE BACK TO IDENTIFYING PEOPLE. >> SHIFT THESE BACK 3 MONTHS IT'LL BE FINE, RIGHT? >> ANYONE ELSE? >> I WONDER IF YOU COULD TALK ABOUT THE EHR INTEGRATION COMPONENT SO THERE ARE SO MANY CHALLENGES THAT TECHNICALLY BUT ALSO HOW MANY PEOPLE ARE TRYING AND CAN'T MAKE IT WORK, COULD YOU TALK ABOUT THE TECH COMPONENT BUT ALSO HOW ACCEPTABLE [INDISCERNIBLE] FOUND THAT. >> LET ME FIND THE RIGHT PERSON TO ANSWER THAT QUESTION, I CAN ANSWER THAT MYSELF AND THAT WE HAVE GONE THROUGH A VERY LENGTHY PROCESS TO EXTRACT THINGS IN OMAPP. AND JUST THAT PROCESS HAS BEEN QUITE LABORIOUS, NOT COMPLETELY AUTOMATED AND STILL A LOT OF HUMAN INTERACTION AND WE ARE TRYING TO GET TO A POINT WHEN THAT IS MORE HEAVRY AUTOMATED THROUGH THE SYNCH FOR SCIENCE INITIATIVE AND WE'RE DRAWING FROM DISCREET HEALTH SYSTEMS WHERE WE HAVE A RELATIONSHIP OF PRACTICE RELATIONSHIP WHERE WE CAN COUNTOT DAT COMING IN THIS CERTAIN FORMAT BECAUSE WE HAD THAT RELATIONSHIP WITH THEM AND THEN WHEN WE OPEN UP TO THE REST OF THE COUNTRY AND FIGURE OUT A WAY TO AGAIN NOT DEPEND ON THAT EXISTING INFRASTRUCTURE AND SO I DON'T KNOW IF I HAVE THE RIGHT FIELD, NO, NO, IT'S FINE BUT FIND ME AFTER IN AND I WILL MAKE SURE I HOOK YOU YOU UP WITH THE CORRECT PERSON IN THE PROGRAM. YES, PLEASE? WE WILL FIND YOU SOME ANSWERS. >> SO QUESTION, WHICH IS YOU HAVEN'T--I KNOW YOU HAVEN'T FIGURED THIS OUT YET BUT YOU'RE GETTING READY TO ENROLL CHILDREN AND INVOLVE PEOPLE WHO ARE DECISIONALLY IMPAIRED AND I UNDERSTAND THE REASONS WHY YOU WANT TO DO THAT BUT THE ETHICAL PROBLEMS WITH THAT ARE PROFOUND. AND SO, WHAT ARE YOU GOING TO DO--THAT'S 1 OF THEM AND THE OTHER THING, THAT I WANT TO ASK IS THAT IT IS CLEAR THAT PEOPLE WHO ARE NOT AFFILIATED WITH AN INSTITUTION THAT IS SUBJECT TO THE COMMON RULE OR SUBJECT TO HIPAA, THERE ARE NO RULES THAT GOVERN THEIR LIABILITY AND SO, 1 OF THE REASONS WHY I WAS PRESSING YOU ON THE QUESTION ABOUT WHAT CONSEQUENCES THERE ARE FROM DOING THE DATA USE AGREEMENT IS THAT THAT THIS IS A PROFOUND ISSUE WITH THIS PROGRAM AND IT'S A LITTLE TROUBLING THAT YOU HAVEN'T SOLVED IT YET. >> SURE. STEF DO YOU WANT ME TO TAKE THIS OR YOU? >> SO WE ARE CURRENTLY WORKING, I MEAN THE WAY THAT OUR DATA IS HELD, VANDERBILT UNIVERSITY AND THEY'RE HOSTING THE DATA ON THE CLOUD SO WE'RE CURRENTLY WORK WITHIN OUR OGC HERE, HERE AT NIH AND WITH THE VANDERBILT FOLKS TO FIGURE OUT WHAT THE ENFORCEMENT OPTIONS MIGHT BE, WORKING TO DEVELOP THE RIGHT STRUCTURE FOR BOTH UPFRONT FOLK DECLARE, YES THESE ARE THE THINGS I WILL NOT DO, I KNOW I'M PROHIBITED FROM DOING THIS, THIS, AND THIS, AND BECAUSE THE DAILY BASIS THEA IS USED WITHIN THE CLOUD AND NOT DOWNLOADED AND WE CAN REQUIRE THE RESEARCHERS OR THE USERS TO POST WHAT THEY'RE DOING, WE CAN SORT OF WATCH WHAT THEY'RE DOING. AND ALSO ABOUT ENFORCEMENT OPTIONS ON THE OTHER END SO WE HAVE BOTH, THE FRONT END AND BACK END AND WE ARE STILL MIGHT BE BECAUSE WE MIGHT NEED TO UNDERSTAND WHERE OUR LEGAL AUTHORITY BEGINS AND ENDS. >> I WOULD LIKE TO MAKE A POINT THAT THE HIPAA RULE NOR COMMON RULE PROVIDE RIGHTS SO THEY'RE JUST UNPROTECTED FUNDAMENTALLY, AND AND ADDRESS THE ISSUE OF CHILDREN AND INDIVIDUALS AND IT IS A HUGE ETHICAL ISSUES. >> SO HOW--HOW ARE YOU THINK BEING IT? >> YEAH, WELL, WE'RE STILL DEVELOPING OUR PLANS SO WHEN WE STARTED THIS PROGRAM, WE BEGAN WITH OUR ADULT PROTOCOL, AND WE'RE SLOWLY OVERTIME MODIFYING RULES THAT NEED DIFFERENT SUPPORT AS THEY'RE ROLLING IN THE PROGRAM, YOU WILL HAVE TO BE 18 OR OLDER TO JOIN THE PROGRAM AND WE ARE WORKING ON THE PROTOCOL FOR BOTH ENROLLING CHILDREN AND ALSO THE POLICIES AROUND THAT AND THE DIFFERENT SURVEY QUESTIONS AND HOW WE WOULD ACTUALLY WALK CHILDREN THROUGH FROM BIRTH ALL THE WAY UP TO THE AGE OF MATURITY THROUGH THE PROTOCOL SO THAT HASN'T STARTED YET AND WE WILL NOT START THAT UNTIL WE WORKED OUT ALL THE ISSUES AND THE SAME THING WITH DECISIONALLY IMPAIRED SO THE WAY WE APPROACH THIS PROGRAM IS OPPOSED TO WAITING UNTIL WE GET IT ESTABLISHED AND WE DECIDE TO LAUNCH WITH THE ADULT PROTOCOL WHICH WE'RE ROLLING OUT AND WORK THROUGH POLICIES AND PROCEDURES NEEDED TO HELP WITH OTHER POPULATIONS THAT NEED DIFFERENT SUPPORT. >> THANK YOU. >> MY QUESTION IS WHETHER ALL OF US IS AN EPIDEMIOLOGICAL STUDY OR AN INTERVENGAL 1 BECAUSE THERE'S A LOT OF DATA, WE ARE TRYING TO UNDERSTAND THE RELATIONSHIP BETWEEN RISK FACTORS AND DISEASE, EXCEPT FOR COMMUNICATING BACK SOME OF THOSE RISK FACTORS WHICH PRESUMABLY WILL EFFECT AND HOPEFULLY REDUCE THE ONSET OF DISEASE, AND SO, WHAT ARE--HOW DO YOU RECONCILE THOSE 2 OFTEN CONFLICTING GOALS. >> YEAH, WELL, I WOULD SAY THAT AGAIN, I WOULD ECHO SOME OF THE SENTIMENTS WE HEARD THIS MORNING IS THAT OUR FIRST AND FOREMOST GOAL IS TO COMPILE THE DATA THAT WOULD BE NECESSARY FOR PEOPLE LIKE YOU, LIKE THE OTHER PEOPLE IN THIS ROOM TO BE ABLE TO DO SOME OF THAT MORE INTERVENTIONAL RESEARCH, BUT WHAT WE'RE REALLY THERE, WHAT WE'RE PAID TO DO ON AN EVERYDAY BASIS TO COLLECT THE INFORMATION, NONAPOPTOTIC THE NECESSARILY TO ANALYZE THE INFORMATION, AND WHILE WE ARE DOING RETURN OF RESULTS AND THERE ARE OPPORTUNITIES TO STUDY HOW THAT GOES AND WHAT ARE THE WAYS WE CAN DO THAT IN A MEANINGFUL WAY, IN A COMPREHENSIVE BUT ALSO IN A CONSCIENTIOUS WAY, AND WE WILL DO SOME OF THAT, WE ARE PRIMARILY CONCERNED WITH AGGREGATING THE DAILY BASIS THEA AND PROVIDING THAT TO RESEARCHERS. SO I WOULD SAY THAT THAT IS PREDOMINANTLY AN OBSERVATIONAL STUDY. GO FOR IT. >> SO THAT WAS A FABULOUS QUESTION AND I'M SURE YOU'RE GOING TO BE GRAPPLING WITH IT FOREVER AND MY QUESTION, KIND OF COMES ON THE HEELS OF THAT, AND THAT IS 1 OF MY REALLY BIG INTERESTS IN THIS WHOLE PROGRAM IS THE WAYS THAT IT'S TRYING TO DIFFERENTIATE ITSELF FROM THE CHILDREN'S STUDY AND THE DETERMINANTS OF THE FAILURE OF THAT STUDY AND EVERYONE IN THIS ROOM KNOWS ABOUT THE CHILDREN'S STUDY AND I THINK--SO, I'M REALLY INTERESTED ESPECIALLY IN HOW YOU ALL ARE APPROACHING DETERMINING WHAT DATA, WHAT HEALTH ESPECIALLY WHAT HEALTH DATA YOU COLLECT AND NOT ACTUALLY USING HYPOTHESIS TO INFORM WHAT ARE THE DATA YOU COLLECT AND YET IT SEEMS TO ME THAT CONSULTING WITH ALL THESE INSTITUTE WHICH IS I APPLAUD YOU FOR INEVITIABLY SET PEOPLE TO THINKING, ALL RIGHT, WELL WE WANT TO LOOK AT HEART DISEASE, WE KNOW THE DETERMINANTS, WE DON'T KNOW OTHERS, WE WANT TO LOOK AT IT ACROSS VARIOUS POPULATIONS FOR VARIES REASONS WE WANT TO MEASURE, SO HYPOTHESIS MUST HAVE BEEN BEHIND A LOT OF THE MEETINGS THAT YOU TALKED ABOUT AND WHEN I THINK BACK TO THE CHILDREN'S STUDY, AND--I THINK THERE ARE POTENTIALLY 28 HYPOTHESIS GENERATING IDEAS AT 1 POINT, THERE WERE 2500 INVESTIGATORS WHO WERE INVOLVED IN THOSE HYPOTHESIS AND SO THAT WAS HYPOTHESIS KRIVEN RESEARCH BUT IT DOESN'T SOUND LIKE YOURS IS AND YET I THINK YOU'RE WALKING CLOSE TO THAT IN YOUR CONSULTATION, SO I WONDER IF YOU MIGHT REFLECT ON THAT BECAUSE IT'S SO INTERESTING AS A FORM OF DESIGNING A COHORT. >> AND YEAH. >> AND YOU START WIDE FRAMINGHAM? >> YEAH. >> SOMEBODY DID. AND THEN COHORTS ARE EVERYWHERE NOW, EVERYBODY'S DOING COHORTS BUT GENERALLY SPEAKING THERE ARE HYPOTHESIS THAT COME RIGHT ALONG WITH THE KIND OF DATA COLLECTED. SO, THANKS. >> YEAH, IS KELLEY STILL IN THE ROOM? NO? OKAY, SETH, DO YOU WANT TO TAKE THIS OR--OKAY? >> I WILL DO MY BEST TO PLAY KELLEY. SO, YEAH, WE CONSCIOUSLY MADE THE DECISION AT THE VERY BEGINNING OF THE PROGRAM THAT THIS WASN'T GOING TO BE A HYPOTHESIS DRIVEN, WE WERE ESTABLISHING A PLATFORM THAT COULD ENABLE ACROSS THE WHOLE SPECTRUM OF HEALTH AND DEC AND WE KNEW WE WOULD HAVE A MILLION PEOPLE AND A CERTAIN DIVERSITY AND THING WE WOULD BE POWERED TO DO AND THEN OVERTIME WHAT WE HAVE TRIED OUR BEST TO DO IS BY USING EFFORTS LIKE THIS TO GENERATE USE CASES SO IF THERE'S A SPECIFIC QUESTION THAT WE THINK WOULD BE RIPE TO ASK OF A STUDY OF THIS SIZE AND SCOPE WHAT TYPES OF DAILY BASIS THEA WE NEED TO ANSWER THAT QUESTION AND THEN LOOK AT WHAT FALLS OUT OF THAT AND SEE WHICH HAS SORT OF LIKE AN IMPACT ON AS MANY, YOU KNOW AREAS OF DISEASE AS POSSIBLE. SO, LIKE WE KNOW IT'S GOING TO BE REALLY IMPORTANT TO COLLECT SLEEP DATA OR DIET DATA BECAUSE IT EFFECTS SO MANY DIFFERENT ASPECTS OF HEALTH AND DISEASE AND WELLNESS. SO THAT'S GENERALLY HOW WE'VE GONE ABOUT IT, I WILL SAY AND KELLEY WOULD BE ABLE TO GIVE YOU A BETTER ANSWER TO THIS QUESTION IF SHE WERE STILL HERE BUT I WILL SAY WE'VE HAD A LOT OF CONVERSATIONS WITH OTHER COHORTS AND IT'S BEEN REALLY INTERESTING TO UNDERSTAND HOW THEY HAVE DESIGNED THEIR PROTOCOL. I MEAN FROM JUST 4 OF US SAT IN A ROOM AND PICKED WHAT WE THOUGHT WERE THE MOST IMPORTANT VARIABLES LIKE WE DID THIS HUGE INPUT GATHERING, OR WE HAD SOME HYPOTHESIS THAT WE WERE DRIVING IT. SO OUR APPROACH HAS BEEN MORE, LET'S TALK TO AS MANY STAKEHOLDERS AS WE CAN AND UNDERSTAND WHAT ARE THE MOST SUPPORT OF IMPORTANT QUESTIONS THAT NEED TO BE ANSWERED AND DEVELOP THE PLATFORM TO BE PRIME TO ANSWER THOSE, AND THE TRUTH IS WE DON'T KNOW WHAT WE DON'T KNOW AND WE WANT TO BE SET UP TO ANSWER QUESTIONS THAT WE ARE NOT GUESSING ARE RELEVANT NOW. I AM NOT SURE THIS IS CO HERENT BUT I THINK--OKAY. >> THIS WILL BE THE LAST QUESTION, AND IF WE HAVE EXTRA TIME AT THE END WE WILL TAKE SOME MORE. >> CAN YOU HEAR ME? >> THANK YOU FOR THE PRESENTATIONS, I WANT TO BRING UP A COUPLE DIFFERENT QUESTIONS AND COMMENTS REGARDING AMERICAN INDIAN POPULATIONS. THANKS. NOW I CAN HEAR MYSELF, SO I WANTED BRING UP QUESTIONS AND CONCERNS WEB CONNECTED GARDING AMERICAN INDIAN POPULATIONS AND I APPRECIATE THAT YOU MENTION DOING TRIBAL CONSULTATION EXPTION I KNOW THERE'S 1 PLANNED WITH THE NATIONAL CONGRESS OF AMERICAN INDIANS LATER TODAY, THEY'RE THEIR NATIONAL CONFERENCE, CAN YOU SHARE MORE ABOUT WHO THOSE CONSULTATIONS ENTAIL, WHAT THAT MEANS AND ALSO BUILDING ON WHAT CONSWALE O WAS TALKING ABOUT EARLIER, CAUTION AGAINST ENGAGEMENT WITH CONSULTATION, THOSE ARE 2 VERY DIFFERENT THINGS, CONCULTATION IS A GOVERNMENT TO GOVERNMENT SCENARIO THAT TAKES PLACE NATION TOINATION AND IT TAKES PLACE MET RAINFALL OF US PROGRAM. AND I'M ALSO CONCERNED ABOUT THE LANGUAGE FOR SPECIAL AND PROTECTED POPULATIONS, I VIEW THEM AS SOVEREIGN NATIONS AND SO PEOPLE WHO ARE AMERICAN INDIANS ARE CITIZEN OF OFFICER RIN NATIONS--SOVEREIGNINATIONS RATHER THAN BEING VULNERABLE PROTECTED POPULATION, SO THANK YOU. >> THANKS FOR THE QUESTION AND THAT'S A GREAT POINT, THE LATTER POINT IS GREAT, WE WILL HAVE TO AJUST THAT SLIDE. SO WE HAVE BEEN WORKING REALLY CLOSELY WITH THE TRIBAL HEALTH RESEARCH OFFICE AT NIH TO DEVELOP A WHOLE CONSULTATION AND ENGAGEMENT PLANNING SESSION SO FOR THE WHOLE SUMMER AND FALL. WE JUST PUT UP SOME INFORMATION ON OUR WEBSITE OF ALL THE DIFFERENT EVENTS THAT WE'RE GOING TO BE AT. I THINK WE'RE DOING A NUMBER OF HHS REGIONAL CONSULTATION STARTING WITH THE 1 TODAY IN RENO, AND THOSE ARE IN LISTED ON OUR SITE AS WELL AS MANY LISTENING SESSIONS IN ORDER TO GO FULLY THROUGH THE CONSULTATION PROCESS, 1 THING THAT CAME UP RECENTLY WITH THE TRIBAL ADVISORY COUNCIL HERE AT NIH IS THE WAY IN WHICH WE ARE PUBLICLY DISPLAYING OUR DATA, ROUND AMERICAN INDIAN AND ALASKA NATIVE WHO ARE SELF-IDENTIFIED THROUGH A PROCESS SO WE DON'T KNOW WHEN SOMEONE COMES INTO THE STUDY WE DON'T ACTUALLY KNOW THEIR RACE OR ETHNICITY UNTIL THEY GO THROUGH THE PPI, SO WE DON'T FIND OUT APPROXIMATE SOMEONE IDENTIFIED UNTIL AFTER THE FIRST SURVEY BUT IN ORDER TO RESPECT THE FAC THAT WE'RE GOING THROUGH CONSULTATION, WE HAVE MASKED THAT INFORMATION AND WORKING WITH THE TRIBAL ADVISORY COUNTS ILLEGALS HERE HAVE DECIDED WE WILL HOLD THAT AS--WE WILL NOT REPORT THAT INFORMATION DIRECTLY THROUGH THE PUBLIC DATA BROWSER UNTIL WE COMPLETED THE CONSULTATION PROCESS, SO WE ARE STILL AT THE VERY BEGINNING OF THAT AND WE WILL GO THROUGH THAT WHOLE, YOU KNOW PROCESS OF GATHERING INPUT AND POSTING IT ONLINE AND CIRCLING BACK. >> I LIKED YOUR SECOND POINT. THANK YOU. THAT'S GOOD CLARIFICATION. >> I GUESS THE ONLY THINK THIS I WOULD ADD TO THAT IS THAT WE SEE FORMAL CONSULTATION AS A PART OF A LARGER PLAN. SO IT'S NOT LIKE ENGAGEMENT IS ENTIRELY COMPRISED OF THE CONSULTATION BUT WE FEEL LIKE THE FORMAL CONSULTATION IS AN IMPORTANT FIRST STEP BEFORE WE START MAKING PLANS IN REACHING OUT THAT WE HAVE, YOU KNOW SOME FEEDBACKOT FORMAL RULES. SO, YEAH. OKAY, SO WITH THAT, AND DON'T WORRY THERE WILL BE MUCH MORE TIME FOR QUESTIONS, I KNOW WE'RE KIND OF RUSHING THROUGH THIS. BUT WE HAVE A VERY, VERY EXCITING THING TO HAPPEN RIGHT NOW. WHICH IS DR. JENNIFER [INDISCERNIBLE] IS JOINING US FROM THE VANDERBILT UNIVERSITY AND WILL GIVE US A DEMO OF THE RESEARCH HUB AND THIS IS THE FIRST TIME ANYONE WILL GET TO SEE THE FUNCTIONING REGISTERING DATA TIERS AND, I'M EXCITED TO SEE THAT AND WE WOULD ASK YOU IF HAVE YOU QUESTIONS, THIS IS A MUCH MORE INTERACTIVE PRESENTATION SO PLEASE COME UP AND ASK YOUR QUESTIONS DURING THE PRESENTATION RATHER THAN WAITING UNTIL THE END, IT WILL BE MORE VALUABLE FOR ALL OF US AND WITH THAT I WILL TURN IT OVER TO THE DOCTOR. >> THANK YOU. >> THANK YOU FOR HAVING ME, TODAY WE WILL TALK ABOUT THE DATA THAT WE ALREADY HAVE WITHIN ALL OF US RESEARCH PROGRAM AND AVAILABLE IN THE PUBLIC DATA BROWSER AND ALSO WHAT'S TO COME DOWN THE ROAD AND WILL BE RELEASED WITH THE REGISTERED TIER RESEARCHER WORK BENCH LATER THIS WINDER. --WINTER. AGAIN TOUCHING ON THE ALL OF US SCIENTIFIC FRAMEWORK THAT THE EARLIER DOCTOR DISCUSSED TALKING ABOUT THE DATA TYPES WE CURRENTLY HAVE AND THEN WE WILL GO INTO THE DATA BROWSER WALK THROUGH SO YOU CAN SEE LIVE, THE NEW RESOURCE AND THEN WE'LL TALK ABOUT FEATURED DATA TYPES, THE DATA LIFE CYCLE AND I'M JUST GOING TO GIVE A RESEARCHER WORK BENCH PREVIEW, WE WILL NOT GO DEEP DIVE INTO IT BUT WE'LL DO SCREEN SHOTS AND TALK ABOUT WHAT IS COMING. SO AS THE DOCTOR MENTIONED, THE ALL OF US SCIENTIFIC FRAMEWORK IS DESIGNED TO ENABLE RESEARCH AND RESILIENCE AND REDUCE HEALTH DISPARITIES AND IMPROVE HEALTH EQUITY, DEVELOP AND IMPROVE RISK ASSESS EXPMENT PREVENTION STRATEGIES, PROVIDE EARLIER AND MORE ACCURATE DIAGNOSIS TO DECREASE ILLNESS BURDEN AND IMPROVE LELGT OUTCOMES AND REDUCE DISEASE IN ILLNESS BURRED KNOW THROUGH IMPROVED TREATMENT IN DEVELOPMENT OF PRECISION INTERVENTION, SO THIS IS THE FRAMEWORK THAT'S GUIDED SO FAR, THE RESEARCH PROGRAM AND THE DATA TYPES THAT WE ARE COLLECTING. AND IT'S HELPING TO ALSO GUIDE FUTURE DATA TYPES THAT WE'RE HOPING TO INCORPORATE INTO THE DATA SET. SO CURRENT ALL OF US DATA TYPE SAYS WE'VE HEARD A LOT TODAY ARE THE ELECTRONIC HEALTH RECORDS, SURVEYS, BIOSAMPLES, GENOMICS WHICH WILL BE COMING SOON, PHYSICAL MEASUREMENTS AND DIGITAL HEALTH TECHNOLOGIES ALSO WHICH WILL BE COMING SOON. SO PARTICIPANT PROVIDED INFORMATION WE HEARD A LOT TODAY, IT'S PPI AND THAT IS THE SURVEYS THAT PARTICIPANTS ARE ASKED TO COMPLETE WHEN THEY ENROLL IN THE PROGRAM. SO THEY'RE ASKED TO COMPLETE THE OVERALL INFORMATION SURVEYS, DEMOGRAPHICS EMPLOYMENT, INCOME,S SECONDARY CONTACT INFORMATION, OVERALL HEALTH, GENERAL HEALTH QUESTIONS AND ASKS ABOUT HOW WELL YOU CAN CARRY OUT YOUR DAILY ACTIVITIES AND ALSO ASKS SPECIFIC QUESTIONS ABOUT WOMEN'S HEALTH, LIFESTYLE ABOUT TOBACCO, ALCOHOL AND RECREATIONAL DRUG USE. SO AFTER THEY COMPLETE THE SURVEYS THEY ARE ASKED TO COMPLETE THE NEXT SET OF HEALTHCARE ACCESS AND UTILIZATION AND FAMILY HEALTH HISTORY AND PERSONAL MEDICAL HISTORY AND HEALTHCARE ACCESS AND UTILIZATION AS THE NAME IMPLIES ASKS ABOUT THEIR ACCESS TO AND USE OF CARE, SPECIFIC QUESTIONS ABOUT HOW PRESCRIPTION DRUG AVAILABILITY AND USE FAMILY HEALTH HISTORY ASKS PARTICIPANTS TO REPORT WHETHER IMMEDIATE FAMILY MEMBERS HAVE SPECIFIC DISORDERS OR DISEASES AND PERSONAL MEDICAL HISTORY ASKS YOU TO TO INDICATE DISEASES OR DISORDERS OR CONDITIONS THAT YOU'VE BEEN DIAGNOSED WITH IN THE PAST OR PRESENTLY HAVE. IT ASKS YOU TO RECALL THE AGE AROUND WHICH YOU WERE DIAGNOSED AND WHETHER OR NOT YOU'RE TAKING MEDICATIONS FOR IT AND IF YOU'RE STILL BEING TREATED FOR THE CONDITION. WE'VE ALSO BEEN WORKING WITH THE PPI SURVEYS, CURRENTLY THERE ARE 3 SURVEYS THAT ARE IN THEIR FINAL FACES WHERE THEY WILL THEN BE SENT TO VANDERBILT DRC TO DO PILOT TESTING WITH GROUPS OF--NOT PROGRAM PARTICIPANTS BUT PARTICIPANTS AND PEOPLE THROUGHOUT THE COMMUNITY, I SHOULD SAY THAT WE DO COGNITIVE ISHT VIEWS WITH AND GET THEIR INPUT ON WHETHER OR NOT THE SURSURVEYS ARE UNDERSTANDABLE, WHETHER THERE'S ANYTHING OFFENSIVE, GETTING INTERNAL AUDIT PUT AND HAVE THEM TALK THROUGH THE SURVEYS THAT GUIDES ANY CHANGES THAT MIGHT NEED TO BE MADE TO THE SURVEYS. AND SO THE NEXT 1 THAT WILL COME UP AND ARE LEASED WITHIN THE PROGRAM IS THE MENTAL HEALTH MODULE AND THIS IS 1 IS THEY'RE SHOOTING TO DEPLOY THAT IN THE FALL WITH THE MOOD MODULE FOR MENTAL HEALTH AWARENESS MONTH AND THIS SURVEY ASKS QUESTIONS ABOUT PERSONALITY, MENTAL HEALTH CONDITION, DIAGNOSIS, ADVERSITY, TRAUMA, ASSAULT AND THEN DEPENDING ON HOW YOU ANSWER SOME OF THE INITIAL QUESTIONS, IT CAN BRANCH, AND USING BRANCHING LOGIC ASK SPECIFIC QUESTIONS ABOUT SPECIFIC DISORDES YOU MAY HAVE. SOCIAL DETERMINANTS OF HEALTH IS ANOTHER SURVEY THAT THE TASK FORCE HAS ALMOST FINALIZED AND THAT ASKS ABOUT--IT'S A BIG SURVEY THAT ASKS ABOUT OPTIMISM, SOCIAL, EMOTIONAL SUPPORT, LONELINESS, PERCEIVED STRESS, DISCRIMINATION, SOCIAL STATUS, FOOD INSECURITY, NEIGHBORHOOD DISORDER AND RELIGION AND SPIRITUALITY AND IT REALLY PULLS FROM A LOT OF DIFFERENT SURVEYS THAT ARE PUBLICLY AVAILABLE TO GET THOSE QUESTIONS AND PUT THEM ALL INTO THIS 1 SURVEY. ALSO DIET, TO ASSESS FOOD AND EATING BEHAVIOR IS UPCOMING. >> [INDISCERNIBLE]. MY UNDERSTANDING IS WITH THE MENTAL HEALTH MODULE, I THINK THE PBI COMMITTEE IS WORKING TO DETERMINE WHAT WILL BE DONE IF SOMEBODY DOES ANSWER BECAUSE I THINK IT'S PHQ09 QUESTIONS ARE IN THERE AND I THINK THEY ARE DEVELOPING A PLAN OF HOW THAT WILL BE HANDLED AND THEY'RE ALSO DEVELOPING A PLAN FOR EACH WHEN WE'RE DOING OUR COGNITIVE INTERVIEWS, WHAT NEEDS TO BE DONE IF SOMEBODY ANSWERS 1 OF THOSE QUESTIONS THAT INDICATES SUICIDAL 8 AND THE MOOD MODULE, THAT IS BEING DEVELOPED BY THE PTSD, I BELIEVE AND THAT ALSO INCLUDES SOME QUESTIONS OF THAT SENSITIVE NATURE AND THEY ARE ALSO WORKING THROUGH WHAT WILL BE DONE IF SOMEBODY ANSWERS THOSE QUESTIONS. >> REALLY, I NEED IT, OKAY, THESE ARE GOING TO BE DONE ON THE COMPUTER. SO THESE PEOPLE CAN BE ANYWHERE IN THE COUNTRY. >> CORRECT. >> OKAY. >> SO THE PLAN IS STILL IN WITH OUR IRB BUT THE NOTION WAS THAT, I JUST WANT TO BE SURE THAT THE 1 WOMAN WHO ASKED THE QUESTION, I WILL ADDRESS IT MORE DIRECTLY, SO THE PLAN, WE'RE STILL QUEPING THE PROTOCOL ON HOW WE WILL HANDLE ANY NOTIONS OF SUICIDOLOGY, AS SOMEBODY IS GOING THROUGH THESE DIGITAL MODULES AND THAT'S STILL TO BE FINALLY APPROVED BY THE IRB, AND WE'VE BEEN GOING BACK AND FORTH, AND WE HELD ON TO IT FOR A WHILE AT THE END OF OUR PLAN AND WE'RE AT THE END OF OUR PORTAL AND IF SOMEONE IS EXHIBITING SOMETHING LIKE THAT, THEN WE HAVE THE HOT LINE POP UP BUT WE'RE STILL DEVELOPING OUR EXACT PLANS FOR HOW WE MIGHT HANDLE EMERGENT NEEDS IN THE MIDDLE OF THE MODULE AND WE HAVE THOUGHT ABOUT THAT AND OUR IRB IS INTIMATELY INTERESTED IN HOW WE HANDLE THAT. >> SO OTHER TYPES WE ARE CURRENTLY CORRECTING IS PHYSICAL MEASUREMENTS, HEIGHT, WEIGHT, BPI, WASTE AND HIP SUCCUMB SUCCUMB FERENCE, BLOOD PRESSURE, HEART, RATE, RHYTHM STATUS, IF AN IRREGULAR HEART RATE IS DETECTED WHEELCHAIR USE AND PREGNANCY AT THE TIME OF ENROLLMENT. AND FROM ELECTRONIC HEALTH RECORDS CURRENTLY WE'RE ABLE TO OBTAIN LABS, MEASUREMENTS, CONDITIONS, PROCEDURES, DRUGS OR MEDICATIONS AND VISIT TYPES FROM THE RECORDS AND IN THE FUTURE WE HOPE TO BE ABLE TO INCLUDE NOTES AND IMAGES SUCH AS CT OR MRI, X-RAYS, IN THE RESEARCH DATA SET. AND ALL OF THE DATA THAT'S COMING IN CURRENTLY TO THE DRC, IS COMING IN TRANSFORMED INTO THE OMOP COMMON DATA MODEL. SOMEONE WAS ASKING ABOUT THAT EARLIER THAT HEALTH PROVIDER ORGANIZATION VS DEDICATED PEOPLE THAT ARE DOING THAT TRANSFORMATION AND THEN SENDING THE DAILY BASIS AT TO THE DRC AND WE'RE ALSO WORKING THROUGH WAYS WHERE WE CAN RECEIVE ELECTRONIC HEALTH DATA IN DIFFERENT FORMATS AND THIN THE DRC ITSELF WORK WITH PARTNERS TO TRANSFORM THAT DATA INTO THE OMOP COMMON DATA MODEL. OKAY, SO NOW I'M GOING TO GO INTO THE RESEARCH ALL OF US WEBSITE. >> CAN I INTERRUPT FOR JUST A SECOND? >> YES. >> ESPECIALLY FOR SOCIAL DETERMINANTS OF HEALTH, A LOT OF RESEARCHERS NOW USE BOTH INDIVIDUAL AND COMMUNITY OR SOCIAL SOCIETAL LEVEL DATA AND WE'VE BEEN WAITING TO SEE IF YOU ARE COLLECTING DATA--SEEMS LIKE THE COMMUNITY DATA YOU ARE COLLECTING IS FROM THE INDIVIDUAL BUT NOT FROM--I MEAN YOU'VE GOT--SOME INDIVIDUALS ARE NOT ATTACHED NECESSARILY TO PARTICULAR COMMUNITIES BUT CERTAINLY SOME ARE WITH YOUR HEALTH, YOUR FEDERALLY QUALIFIED HEALTH CENTERS IS OTHER HEALTH CENTERS THAT YOU FUNDED. SO I'M CURIOUS TO KNOW WHETHER THERE ARE COMMUNITY LEVEL VARIABLES AND HOSPITAL LEVEL VARIABLES THAT YOU WILL BE CHARACTERIZING, NOT FROM THE LEVEL OF THE INDIVIDUAL, BUT SO THAT PEOPLE COULD DO MULTILEVEL ANALYSIS OF SOCIAL DETERMINANTS? >> THAT I'M NOT SURE OF. >> I SHOULD JUST HOLD THE MIC, SHOULD I ARE JUST HAVE 1 ON ME. >> YEAH. >> SO THAT'S EXACTLY THIS; THAT'S EXACTLY THE SORT OF SUGGESTION WE'RE HOPING TO GET FROM THESE 2 DAYS, RADIOIT? WE HAVE NO PLANS AS FAR AS I KNOW CURRENTLY TO COLLECT HOSPITAL OR COMMUNITY LEVEL DATA OR MAYBE WE DO IN SOME SPECIFIC AREAS BUT IT WOULD--THAT'S THE SORT OF THING WE WANT TO TALK ABOUT HERE, WHAT SORTS OF DATA TYPES, LIKE THAT WOULD BE REALLY USEFUL FOR THINKING THROUGH, YOU KNOW KEY QUESTIONS THAT THIS PLATFORM COULD BE USEFUL TO ANSWER. SO THERE IS A PLAN TO LOOK AT COMMUNITY LEVEL DATA USING GEOCODING. SO IT'S CERTAINLY NOT AS PRECISE AS OTHER COMMUNITY LEVEL DATA BUT WITH GEOCODING THE ADDRESSICAL CANCULATING AREA DEPRIVATION INDICES LIKE FROM THE AMERICAN COMMUNITY SURVEY. >> OKAY, SO LET'S TACK A ELECTRIC AT THE RESEARCH HUB. SO THIS IS THE PUBLICLY AVAILABLE WEBSITE, ANYBODY CAN GO TO IT RIGHT NOW, IT'S WWW.RESEARCHALLOFUS.ORG. THIS IS THE INITIAL LEADING PAGE WHERE YOU CAN SEE MORE ABOUT THE RESEARCH HUB AND THEN YOU CAN ALSO TAKE A LOOK AT DATA SNAPSHOTS, LET ME SEE IF I CAN READ THIS, DATA SNAPSHOTS AND THIS IS UPDATED ON A MONTHLY BASES WHERE CAN YOU GET AN IDEA OF HOW MAN PARTICIPANTS HAVE ENROLLED, MOW MANY ELECTRONIC HEALTH RECORDS WE'VE BEEN ABLE TO COLLECT AND HOW MANY BIOSAMPLES WE'VE RECEIVED AND I WILL CLICK ON THAT AND SHOW YOU MORE DETAILS, SO, AGAIN, PARTICIPANT NUMBERS, YOU CAN TAKE A ELECTRIC AT THE PARTICIPANT ENROLLMENT BY GEOGRAPHY. IF YOU HOVER OVER EACH OF THOSE STATES, CAN YOU SEE HOW MANY PARTICIPANTS HAVE ENROLLED. YOU CAN ALSO SEE THE PARTICIPANT COHORT BROKEN DOWN BY AGE AND GENDER IDENTITY AND RACE AND ETHNICITY. AGAIN WHEN YOU HOVER, CAN YOU GET A LITTLE MORE DETAILS INTO THE NUMBERS. OKAY, LET'S GO BACK, YES? >> I COULDN'T HOVER AND GET DISTRICT OF COLUMBIA OR PUERTO RICO, IS IT JUST STATES, YOU'RE NOT COLLECTING OTHER INFORMATION ABOUT U.S. PEOPLE WHO WOULD QUALIFY-- >> [INDISCERNIBLE]. >> I WAS LIKE WHAT? I DON'T KNOW IF IT'S MAYBE JUST THE MAP IS NOT--NO? YEAH, WE MAY HAVE TO--I CAN TAKE THAT BACK TO THE TEAM. AM I IN THE WRONG SPOT? YEAH, YEAH, THAT'S GOOD FEEDBACK I CAN TAKE BACK TO THE RESEARCH HUB TEAM. THEY'RE DOWN THE HALL, SO, OKAY. OKAY, I'LL GO BACK NOW AND JUST SHOW THAT BEFORE WE GO TO THE DATA BROWSER, YOU CAN GET MORE DETAILED INFORMATION ABOUT THE DATA SOURCES THAT WE'VE ALREADY STARTED TALKING ABOUT AND YOU CAN SIGN UP TO GET UPDATES, SO YOU'LL GET--YOU CAN GET AN E-MAIL THAT WILL SEND YOU NEWS AND UPDATES AND LET YOU KNOW OF LIKE WHEN NEW THING VS COME OUT IN THE RESEARCH HUB. SO EVERYBODY SHOULD SIGN UP. OKAY, SO THE DATA BROWSER, LET'S TAKE A LOOK AT THE DATA. FIRST I WANT TO POINT OUT THAT WE AT THE DRC ALSO ARE PART OF THE RESEARCH SUPPORT TEAM OR I'M PART OF RESEARCH SUPPORT TEAM THAT'S LOCATED AT THE DRC AND WE WORK TO DEVELOP IF, AQs AND TRYING TO ANTICIPATE THINGS THAT PEOPLE WILL WANT TO KNOW MORE ABOUT WITH THE DATA AND THE PLATFORM AND EVERYTHING, MAKING INTRODUCTORY VIDEOS TO KIND OF STEP PEOPLE THROUGH THE RESEARCH HUB ESPECIALLY PARTICIPANTS THAT ARE NOT AS FAMILIAR WITH THE PROGRAM AND MAYBE WANT TO SEE HOW THEY CAN START LOOKING AT THE DATA FOR THIS COHORT THAT THEY'RE A PART OF AND THEN ALSO USER GUIDE THAT WILL HELP WALK PEOPLE THROUGH USING THE TOOL. UPON SO FIRST, I WANT TO POINT OUT THAT YOU CAN LOOK AT EHR DOMAINS, SURVEY QUESTIONS AND PROGRAM PHYSICAL MEASUREMENTS, AND SINCE WE'VE BEEN TALKING ABOUT SURVEYS, LET'S JUMP THERE, FIRST. LOOKING AT THE BASIC SURVEY, SO HERE YOU CAN SEE THAT OVER 104,000 PEOPLE--YEAH 104,000 PEOPLE HAVE ANSWERED THE BASIC SURVEY, IF YOU WANT TO SEE THE SURVEY OR DOWNLOAD IT AS A PDF, CAN YOU DO THAT AND THEN YOU CAN SEE IT IN A WRITTEN DOCUMENT FORM. BUT HERE WHAT YOU CAN DO IS YOU CAN GO THROUGH AND GO QUESTION BY QUESTION AND SEE THE ANSWERS, SO FIRST QUESTION BEING IN WHAT COUNTRY WERE YOU BORN. YOU CAN SEE THAT THE ANSWER CHOICES ARE USA OR OTHER. AND YOU AND AGAIN LOOK AT THE BREAK DOWN OF PERCENTAGE OF PARTICIPANTS WHO ANSWERED USA, 14%, OTHER? ONLY .84% OF PEOPLE SKIP THE QUESTION OR DID NOT ANSWER. SO LET'S CLICK ON THIS LITTLE GRAPH ICON AND HERE YOU CAN SEE, FURTHER BREAK DOWN OF WHO ANSWERED THIS QUESTION WITH THE RESPONSE USA, FEET BROKEN DOWN BY SEX ASSIGNED AT BIRTH, SO FEMALE, MALE, OR OTHER. YOU CAN ALSO SEE HOW MANY PEOPLE ANSWER THIS SURVEY QUESTION AS A USA BROKEN DOWN BY AGE. AND I'M NOT GOING TO CLICK ON EVERY SINGLE THING BUT 1 THING THAT YOU CAN SEE IS WHEN YOU CLICK ON A QUESTION THAT HAD BRANCHING LOGIC WITHIN THE SURVEY, SO THIS QUESTION IN PARTICULAR WHAT TERMS BEST EXPRESS HOW YOU DESCRIBE YOUR GENDER IDENTITY, CAN YOU SEE IF YOU ANSWER NONBINARY OR TRANSGENDER, YOU GET FOLLOW UP QUESTIONS AND SO YOU CAN SEE THE LITTLE ARROW HERE, OPEN UP THAT QUESTION, YOU CAN SEE THE FOLLOW UP QUESTION THAT THE PARTICIPANT RECEIVED AND THEN LOOK AT THE ANSWER CHOICES, AGAIN, CAN YOU GET MORE DETAILED AND SEE THE SEX ASSIGNED AT BIRTH AND THE AGE THE SURVEY WAS TAKEN GRAPHICALLY SHOWN HERE. YES MA'AM? >> CAN I ASK A , CAN YOU DO CROSS TABS SO TO DETERMINE YET THE NUMBER OF ARE MALES WITHIN THE CERTAINAIN GROUP OR-- >> NO, NOT--AND THAT'S JUST AGAIN, ANOTHER 1 OF THOSE POLICIES IN PLACE TO PROTECT PARTICIPANT RE IDENTIFICATION. SO I'M NOT GOING TO GO THROUGH THE WHOLE SURVEY BUT, THAT GIVES YOU AN IDEA OF HOW YOU CAN LOOK THROUGH AND SEE HOW MANY PEOPLE ANSWERED EACH QUESTION AND 1 THING THAT YOU'LL NOTE, SO LET'S LOOK AT WHICH CATEGORIES DESCRIBE YOU. HERE CAN YOU SEE MORE DETAIL FOR RACE AND ETHNICITY THAT YOU WILL BE ABLE TO SEE IN THE REGISTERED TIER THAT THEY WERE TALKING ABOUT EARLIER. AND THAT'S JUST BECAUSE WE ARE NOT SHOWING ANYTHING, NO ROW LEVEL DATA AND ALL THE NUMBERS ARE ROUNDED UP TO THE GROUPS OF 20 SO THAT'S THE PRIVACY TEAM HAS DETERMINE THAD THAT IS SATISFACTORY TO BE ABLE TO SHOW LIKE A LITTLE MORE DETAIL ON THE BREAK DOWN OF THE RACE AND ETHNICITY AND THE GENDER IDENTITY QUESTIONS. YES? >> CAN YOU TELL US HOW YOU'RE HANDLE THINKING PEOPLE WHO MIGHT CHOOSE MULTIPLE RACIAL AND ETHNIC IDENTITY SYSTEM THAT CAPTURED HERE IN SOME WAY AND HOW IS THAT-- >> YES, SO THEY'RE MULTISELECT QUESTIONS, AND SO, THE PARTICIPANTS, MY UNDERSTANDING IS THAT THE PARTICIPANTS CAN SELECT AS MANY DIFFERENT RACE OR ETHNICITIES AS THEY WANT AND THEY WILL BE COUNTED EACH TIME THAT THEY SELECT SOMETHING. >> [INDISCERNIBLE] >> YES IT WILLAD UP TO MORE THAN 100%, CORRECT. >> ANOTHER QUICK QUESTION ON THAT. I'M WONDERING IF THERE WAS A DISCUSSION ON THE GENDER IDENTITY QUESTION ABOUT THE INCLUSION OF THE TERM HOW YOU DESCRIBE--MY UNDERSTANDING IS THAT GENERALLY IT SHOULD BE WHAT IS YOUR GENDER IDENTITY, NONAPOPTOTIC THE A QUESTION OF HOW YOU'RE DESCRIBING IT, 1--IT'S WHAT IT IS. SO IT'S WORTH DISCUSSING,. >> I KNOW THE PBI COMMITTEE HAS BEEN WORKING CLOSELY WITH MITCH, IS THAT HIS NAME, MITCH? COMMUNITY PARTNER TO DETERMINE IF THERE'S BETTER WAYS THAT QUESTION CAN BE ASKED SO WE'RE DEFINITELY--SO THE APPROXIMATE, PI COMMITTEE IS LOOKING INTO THAT. ANOTHER THING YOU CAN DO IN TERMS OF SURVEYS IS WE HAVE UNDER THE DAILY BASIS THEA TAB, DATA SOURCES, THE SURVEY EXPLORER AND THIS ALLOWS TO YOU GO IN AND GO SURVEY BY SURVEY TO EXPLORE THE SOURCE INFORMATION, SO IF YOU'RE CURIOUS WHY WE CHOSE A PARTICULAR--OR WHERE WE GOT A PARTICULAR QUESTION, I KEEP SAYING WE BUT IT'S NOT THE DRC THAT'S DOING THIS, SORRY, IT'S ACTUALLY THE PARTICIPANT PROVIDED INFORMATION COMMITTEE. I SIT IN ON THOSE CALLS SO I KEEP SAYING WE, THINKING THAT I'M PART OF THAT, BUT, SO IT'S NOT THE DRC. WE'RE JUST GETTING THE DATA. SO, YOU CAN EXPLORE THE SOURCE INFORMATION, SO FOR INSTANCE YOU CAN LOOK QUIET BY QUESTION AGAIN AND SEE WHERE THE ORIGINAL SOURCE QUESTION TEXT CAME FROM AND WHAT COUNTRY WERE YOU BORN, FROM THE NHANES SURVEY AND YOU CAN GO THROUGH AND DO HAD THIS FOR EACH QUESTION, SO WHENEVER POSSIBLE THE COMMITTEE DID TRY TO USE QUESTIONS THAT WERE ALREADY AVAILABLE IN STANDARDIZED SURVEYS THAT HAVE BEEN VALIDATED. HOWEVER, OCCASIONALLY WORDING WAS CHANGED BASED ON SOME OF THAT FEEDBACK WE'VE GOTTEN FROM DOING COGNITIVE INTERVIEWS, OR THEY MAY HAVE HAD TO JUST CREATE THEIR OWN QUESTION, IF THERE WASN'T 1 ALREADY VALIDATED AND AVAILABLE. SO BACK TO DATA SOURCES. OH THAT'S NOT WHAT I WANTED TO DO. YES? >> SURVEY IS SORT OF A SNAPSHOT OF THE PERSON FOR THE PARTICULAR MOMENT IN A PARTICULAR DAY, SO FOR INSTANCE DIET, EATING HABIT, PLANS, MOOD, MENTAL HEALTH, YOU KNOW SITUATIONS, WILL CHANGE THROUGHOUT THE YEAR AND IN A PARTICULARLY BEFORE HOLIDAYS, DURING HOLIDAYS, AFTER THE HOLIDAYS, THERE'S A LARGE, YOU KNOW VARIABLES, THIS WHOLE BIG PERIOD, UPON SOME PEOPLE GO THROUGH HAPPY TIME, BEFORE WEDDING, DURING WEDDING PLANNING, AFTER WEDDING OR SOMEBODY YOU KNOW THEY'RE ILLNESS IN THE FAMILIES OR TAKING CARE OF SOMEBODY, THERE'S GRIEVING PERIODS OR IT DEPENDS ON WHERE THESE PEOPLE ARE IN THEIR LIFE, SO, HOW DO YOU CAPTURE A PERSON'S DATAAISE WHOLE INSTEAD OF HAVING SNAPSHOT OF THIS BROWSER OR THAT BROWSER, OR OTHER PEOPLE BECAUSE WE WANT TO HAVE SORT OF THE REAL HUMAN LIFE AND HUMAN DATA BUT IF WE'RE JUST PICKING SNAPSHOTS FROM EVERYBODY AND WHAT DO WE END UP WITH I DO NOT KNOW BUT I'M JUST THROWING THIS OUT? >> YEAH THAT,'S SOMETHING I KNOW THE PPI COMMITTEE WAS WORKING WITH THE SCIENCE COMMITTEE TO DETERMINE WHEN WHEN TO BE--WHEN PARTICIPANTS SHOULD BE REASSESSED SO GIVEN THE SURVEYS AGAIN TO TAKE THEM AGAIN AND I THINK SOMEBODY PRESENTED SLIDE EARLIER MAYBE EVERY 3 YEARS, I KNOW THAT'S A BIG GAP, BUT THAT'S SOMETHING WE CAN TAKE AS FEEDBACK BACK TO THE PPI COMMITTEE AND ALSO THE MOOD MODULE, THAT'S DESIGNED TO BE SOMETHING WHERE IT'S MORE INTERACTIVE AND YOU CAN ON A DAILY BASIS GO IN AND INDICATE HOW YOU'RE FEELING THAT DAY, SO THAT MIGHT HELP TO GET A LITTLE MORE OF THE MOOD DATA. >> THANK YOU. >> SO THE DATA HUB SEEMS TO SAY THAT OVER QUARTER MILLION PEOPLE HAVE REGISTERED, BUT YOU HAVE WHERE IT QUANTIFIES ACCESS TO ELECTRONIC HEALTH RECORD THAT SAYS 80,000 PLUS, SO WHAT'S THE UPDATE ON WHAT PERCENTAGE OF PEOPLE ARE ACTUALLY GRANTING ACCESS TO THE EHR AND IF THOSE NUMBERS ARE ROUGHLY CORRECT, WHAT STUDY VS YOU DONE OF THE BIAS THAT INTRODUCES. BECAUSE THAT MEANS MOST PEOPLE ARE NOT GRANTING, AT LEAST WHO REGISTER ARE NOT GRANTING ACCESS TO THE EHR. >> YEAH, IF YOU DON'T MIND. >> SO, MEGAN HAS THE EXACT NUMBERS AS I UNDERSTAND, I THINK IT'S IN THE HIGH 80% RANGE CONSENTS TO BOTH, BUT THERE'S A TECHNOLOGY ISSUE OF WHEN THEY GET UPLOADED FROM THE HEALTH PROVIDER ORGANIZATION SO THAT NUMBER IS A LAGGING IN A LOT OF WAYS BECAUSE THERE'S A QUARTERLY LOAD-IN FROM THE ORGANIZATIONS OF THE ACTUAL DAT BAH THE NUMBER OF CONSENT DIFFERENT. SO THE NUMBER OF PEOPLE WHO COMPLETE--SO THE HIPAA AUTHORIZATION IS SEPARATED FROM THE PRIMARY CONSENT SO PEOPLE CONSENT SEPARATELY TO THE RELEASE OF THE ELECTRONIC HEALTH RECORDS AND WE HAVE NO ESTIMATION OF WHAT THE CORRECT OR REASONABLE LEVEL OF CONSENT SHOULD BE BUT WE HAVE FOUND THAT THE VAST MAJORITY ABOVE 85% OF PEOPLE ALSO CONSENT TO THE RELEASE OF THE ELECTRONIC HEALTH RECORD. BUT AGAIN, JUST TO JOHN'S POINT, THERE IS A TECHNICAL BOTTLENECK WITH THE HPOs WHO HOWES THE ELECTRONIC HEALTH RECORDS AND THEN RELEASING THEM TO THE DATA HUB ITSELF. >> YEAH, SO THEY MAY BE CONSENTED WUTHE TECHNOLOGY HASN'T WORKED YET TO DRAW THOSE DATA FROM THE HPO, DOES THAT MAKE SENSE? >> AND EVEN IF WE GET THE RAW DAT ATHE TEAM AT THE DRC HAS TO WORK TO CURATE THAT DATA SO THAT'S JUST ANOTHER STEP THAT I WILL GO THROUGH LATER THAT ALSO CREATES THAT LAG. >> ARE YOU STUDYING THE DECLINERS? >> NOT AT THE DRC. >> RIGHT. >> SO THIS WOULD BE 1 OF THE CASE STUDIES YOU COULD PROPOSE, THIS IS WHY WE ARE CONVENED HERE, IS TO SAY WE NEED TO RELEASE THE--THE PROGRAM SHOULD RELEASE THOSE DATA SO SCIENTISTS CAN STUDY THOSE WHO HAVE DECLINED. >> WELL, YOU WANT TO STUDY BOTH BECAUSE OF THE INTRUSIVENESS OF WHAT YOU'RE COLLECTING, EVERYTHING FROM REPRODUCTIVE HISTORY TO MENTAL HEALTH, TO DRUG AND ALCOHOL USE, I CAN'T THINK OF MUCH MORE INTRUSIVE QUESTIONS. >> YEAH, YEAH, EXACTLY, SO THIS IS WHY WE ARE CONVENED HERE, IS TO DEVELOP THESE CASE STUDIES. AND SO, IF YOU'RE FEELING THAT THIS WOULD BE IMPORTANT FOR US TO STUDY, THEN PROPOSE A CASE STUDY ON IT. I WILL LET YOU CONTINUE JENNIFER. >> THAT'S OKAY. ONE THING ALSO AT THE DRC, WE HAVE THE PILOT RESEARCH CORE AND WE ARE STARTING TO LOOK AT THE ACTUAL DATA THAT'S COME IN THROUGH THE SURVEYS AND WE'RE TRYING TO UNDERSTAND LIKE AT WHICH POINT DURING SURVEYS DO PEOPLE DROP OFF, LIKE THEY HIT A CERTAIN QUESTION AND THEY'RE LIKE, YOU KNOW WE DON'T WANT TO DO THAT ANYMORE, OR WHATEVER SO THAT'S SOMETHING WE'RE LOOKING AT TO SEE WHAT'S GOING ON WITH THAT. IT'S NOT REALLY IN OUR PERVIEW TO GET PRIVILEGED ACCESS TO THAT DATA TO BE ABLE TO DO THAT TYPE OF ANALYSIS. >> [INDISCERNIBLE]. >> TO THE DATA TO ACTUALLY MAKE CONCLUSIONS. - THE DATA COMING IN AT THE DRC. >> THANK YOU. >> OKAY. >> JUST SAYING WHY WE'RE NOT DOING THAT TYPE OF RESEARCH. YEAH. >> SO I HAD A QUESTION. >> YES? >> I DIDN'T HAVE A CHANCE TO LOOK THROUGH ALL THE QUESTIONS BUT IS IT CLEAR GUIDANCE IN TERMS OF WHY CERTAIN--WHY EVERY& QUESTION IS BEING ASKED? SO I WAS LOOKING AT THE QUESTION ON WHAT IS YOUR MARITAL STATUS? NOW I DON'T KNOW WHAT CAME BEFORE OR AFTER THAT, BUT I'M NOT SURE THAT'S THE MOST IMPORTANT QUESTION. BECAUSE THE STATUS MAY HAVE CHANGED RECENTLY AND THAT MAY BE WHAT MAY HAVE THE MOST IMPACT ON HEALTH. SO I THINK DISRUPTIONS TO 1'S STATUS I THINK IS AN IMPORTANT QUESTION AND SO I THINK IT'S IMPORTANT THAT WE--AND MAYBE THAT'S PART OF THIS GATHERING WE'RE HERE AT TODAY FOR A CASE STUDIES BUT I THINK IT'S IMPORTANT THAT WE LOOK AT OR AT LEAST I'D LIKE TO KNOW THAT EVERY QUESTION IS KIND OF ADJUDICATED AS TO WHAT IS IT THAT WE'RE REALLY TRYING TO UNDERSTAND. >> YEAH. >> THAT IS ABSOLUTELY WHAT WE'RE HERE FOR. SO PLEASE BRING THAT UP AGAIN IN YOUR SMALL GROUPS, OKAY? >> AND SOMETIMES WITHIN THE SURVEY, THERE ARE LITTLE CHUNKS OF TEXT THAT WILL TELL YOU WHY YOU'RE BEING ASKED A CERTAIN QUESTION. I DON'T RECALL IF THERE WAS--I THINK THAT'S FOR MORE OF THE SENSITIVE QUESTIONS THAT WE TRY TO--PBI COMMITTEE TRIED TO JUSTIFY WHY THE QUESTIONS ARE BEING ASKED. >> I WILL SAY, TOO, 1 OF THE OPPORTUNITIES, 1 OF THE THINGS TO KEEP IN MIND AS WE GO INTO BREAK OUTS AND START DEVELOPING USE CASES, THE OPPORTUNITY OF THE STUDY IS IF WE ASK PEOPLE A QUESTION NOW AND ASK THEM AGAIN 2 YEARS LATER AND THAT STATUS HAS CHANGED IF WE HAVE AN ENGAGED GROUP OF PARTICIPANTS, THERE'S AN OPPORTUNITY TO GO TO THEM AND ASK HAS THERE BEEN A TRANSITION IN YOUR LIFE THAT HAS MEANING AND TAKE COHORTS AND ASK DEEPER QUESTIONS AND THAT'S SOMETHING YOU WOULD LIKE, YOU WILL STEAL ERIC'S TERM, TO HELP US THINK THROUGH WHAT WE WANT TO DO BECAUSE WE COULD DO EVERYTHING, BUT EVERYTHING IN OUR STUDY IS, YOU KNOW WHATEVER IT COSTS TIMES 1 MILLION SO WE HAVE TO BE THOUGHTFUL ABOUT WHAT TYPES OF THINGS WE'RE ADDING ON TO PROTOCOL OVER TIME AND THAT'S WHY WE WANT TO DO THESE SESSIONS WITH EXPERTS. >> I GUESS, SO I HAVE A QUESTION, OR MAYBE JUST A COMMENT ABOUT THE EXPERTISE, A COUPLE OF THE LAST QUESTIONS ISSUES DIDN'T SEEM REALLY TO BE--THEY HAVE ETHICAL RELEVANCE, BUT THEY DON'T SEEM TO BE LC QUESTIONS AS MUCH AS QUESTIONS OF SCIENTIFIC DESIGN OF THE RESEARCH PLATFORM. SO THAT IN SO FAR AS THE USE CASES WOULD IDENTIFY THOSE ISSUES, THEY DON'T SEEM TO BE SPECIFICALLY LC USE CASES OR MAKING THE DAILY BASIS THEA USEFUL FOR LC RESEARCH OR--SO I THINK AT SOME POINT CLARIFICATION OF HOW THIS--THE FUNCTION OF THIS GROUP IS BEING UTILIZED WOULD BE HELPFUL. >> I'M NOT GOING TO ATTEMPT TO ANSWER THAT EXCEPT TO SAY THAT THAT WILL BECOME CLEAR DURING THE BREAK OUTS, I IMAGINE THAT WILL BE PART OF THE FACILITATED DISCUSSION BECAUSE THERE ARE THOSE 2 ELEMENTS, RIGHT? THERE'S THE HOW WE CONDUCT THE RESEARCH AND THEN THERE'S WHAT RESEARCHERS ASK OF THE DATA OR SPECIMENS OR PARTICIPANTS, OR THERE'S 2 ASPECTS OF THIS. >> I'M GOING TO RESPOND TO THAT IN--NOT IN AN ALL OF US HAT BUT IN MY MORE PERSONAL HAT, BUT I DO THINK THAT FROM MY PERSPECTIVE THAT THE SI AND LC HAS NOT HAD AS MUCH OF THE SOCIAL IMPLICATIONS AS IT COULD ESPECIALLY GIVEN THAT WE HAVE SUCH A LARGE REPRESENTITATION OF RACIAL AND ETHNIC MINORITIES AND OTHER GROUP WHO IS MAY HAVE TRADITIONALLY NOT BEEN INCLUDED IN THE RESEARCH SO I THINK WE HAVE TO THINK MORE BROADLY ABOUT THE SOCIAL IMPLICATIONS ESPECIALLY AT THE LEVEL OF THE COMMUNITY. >> OKAY, ANY OTHER QUESTIONS? BEFORE I KEEP GOING, OKAY, GO AHEAD. >> THIS IS NOT A QUESTION DIRECTLY FOR THE SPEAKER BUT MANY TIMES THROUGHOUT THIS MORNING WE'VE HEARD THE TERM USE CASE AND I HAVE TO ADMIT AND I DON'T KNOW IF I'M THE ONLY PERSON IN THE ROOM, BUT I HAVE NO IDEA WHAT IS MEANT BY THE TERM, AND SO AS WE MOVE FORWARD, I WAS HOPING THAT FIRST PUT FORWARD MY IGNORANCE AND HOPEFUL THAT I'M NOT ALONE IN REQUESTING A DEFINITION SO THAT WAY AS WE'RE MOVING FORWARD TOGETHER, PARTICULARLY WHEN I SAW THE GOALS EARLIER TODAY, I MIGHT BE ABLE AND MAYBE THOSE THAT WERE CLAPPING MIGHT ALSO BE ABLE TO ENGAGE WITH THE QUESTION OF DETERMINING A USE CASE IN THE 3 DIFFERENT GROUPINGS, THANK YOU. >> I GUESS MY QUICK QUESTION IS AND I AGREE COMPLETELY WITH THAT STATEMENT BUT WITH ALL THE DAILY BASIS AT BEING COLLECTED, WITH HALF OF US, MOST OF US IN THIS ROOM WOULD HAVE FATIGUE FILLING OUT THESE SURVEYS AND I WANT TO KNOW IF THERE'S PRIORITIZATION OF THE QUESTIONS THAT YOU GET THE MEATYST 1S, THE MOST MEANINGFUL QUESTIONS ANSWERED BEFORE SOMEONE DROPS OFF, IS IT MADE CLEAR TO PEOPLE THEY CAN FILL OUT SOME QUESTIONS, THEY DON'T HAVE TO PROVIDE ALL ANSWERS, WHAT IS COMMUNICATED TO PARTICIPANTS WITH THAT. >> YEAH, I THINK WHAT YOU PROBABLY WOULD LIKE TO DO IS GO TO 1 OF THE SURVEYS AND LOOK AT THE PDF SO CAN YOU SEE LIKE THE INTROLANGUAGE, I CAN'T REMEMBER WHAT IT IS BUT IT DOES SAY IF ANSWERING, DON'T FEEL LIKE YOU NEED TO ANSWER ALL THE QUESTIONS, THEY'RE ALLOWED TO CONTINUE ON, WITHOUT ANSWERING A QUESTION. YOU CAN JUST SKIP QUESTIONS AND WHAT FTION THE FIRST PART? >> I AM THINKING WITH THE PEOPLE WHO HAVE A ROLE, TO HAVE AN IDEA AS TO WHERE PEOPLE ARE DROPPING OFF AND MAKE CHANGES MIDSTREAM AND WITHOUT PRIORITIZING KEY QUESTIONS YOU NEED ANSWERS TO, THERE WILL BE ALL OF THESE QUESTIONS THAT PROVIDE LESS RELEVANT INFORMATION THAT YOU MAY BE GETTING ANSWERD TO BUT NOT TO THE MAIN 1S. >> RIGHT. AND I KNOW WITHIN THE PBI COMMITTEE AND TASK FORCES THAT GENERATE THE SURVEYS, THEY DO HAVE SURVEY METHODOLOGYSTS THAT ARE THINKING ABOUT THOSE TYPES OF THINGS, LIKE THE ORDERING OF QUESTIONS, PARTICIPANT BURDEN, THAT TYPE OF THING, SO THAT'S HELPING TO GUIDE THE ORDERING OF QUESTIONS. >> BUT SINCE YOU'RE AT A POINT THAT YOU HAVE DATA YOU MIGHT WANT TO LOOK AT IT AND MAYBE MODIFY, SWITCH STREAM BEFORE YOU KEEP GOING, ENROLLING MORE PEOPLE. >> RIGHT. >> YES. >> NOT TO RESPOND SUBSTANTIVELY BECAUSE--WE DO HAVE A PROCESS IN THE PROTOCOL THAT ALLOWS US TO DO TESTING AND SO, WE'VE STARTED THIS WITH THE LOWEST RISK WHICH IS THE PREENROLLMENT MARKETING CONTENT AND MESSAGE A VERSUS MESSAGE BR, WE ARE ROLLING THAT OUT TO CONSENT TO IMP EMENTATION OF A DIFFERENT TEXT, SO WE HAVE A PROCEDURAL MECHANISM TO TEST VERSIONS OF SURVEYS AGAINST EACH OTHER OVER TIME SO IT'S AGAIN AND TO THE PREVIOUS QUESTION ABOUT THE USE CASE, USE CASES WE HAVE TEMPLATES, WHEN YOU'RE--ONCE YOU'RE IN THE WORKING GROUP, YOU WILL SEE THE TEMPLATES FOR THE USE CASES SO THIS IS A GREAT EXAMPLA YOU COULD MAKE INTO A USE CASE, TESTING DIFFERENT VERSIONS OF SURVEYS TO LITERALLY EXPLORE& FATIGUE OVERLOAD AND OTHER ISSUES OF THIS. I CAN ALSO SAY THAT FROM THE BEGINNING THE IRB HAS BEEN WORRIED ABOUT THIS, NOT TO SPEAK FOR THEM BUT AS SOMEONE WHO RESPONDS A LOT TO THE LETTERS THEY SEND, THAT FROM THE VERY BEGINNING, EVERYTHING ABOUT THE PROGRAM THEY'RE WORRIED ABOUT FATIGUE ASK COGNITIVE BURDEN, AND SO WE'VE TRIED TO SET UP THESE PROCESSES THAT LET US DO TESTING AND THE A-B TESTING IS VERY POPULAR IN TECHNOLOGY BUT OUR WHYED IS THAT WE START BY ESTABLISHING SOMETHING THAT WORKS AND TEST FOR NONINFERIORITY AND TEST ACTUAL VERSIONS OF IT THAT WE MIGHT HAVE MORE LEEWAY TO DO SO FEEL FREE TO MAKE A CASE OUT OF THAT AND YOU WILL HAVE TEMPLATES SARAH, TORI, MEGAN AND I ARE FACILITATORS AND WE WILL HAVE EXTENSIVE INSTRUCTIONS AND HOW CO CREATE THE USE CASES IN THE GROUPS. >> THANK YOU. YES? >> SO THESE TEMPLATES WILL BE EMPTY. WE WILL BE ASKED TO PUT DATA IN, RIGHT? OR PUT OUR QUESTIONS IN AND-- >> RIGHT. WHEN WE GET TO THE TEMPLATES WE WILL DO THIS IN A FACILITATED WAY, THERE WILL BE IDEATION, THEN CLUSTERING, THEN WE WILL DETAIL UP THE USE CASES AS WE GO, BUT YOU'RE NOT GOING TO BE WITHOUT INSTRUCTION, WE WILL HAVE DATA DICTIONARYS, THAT WE CAN GET AT THE ACTUAL DETAILS AND THE IDEA IS THAT WE WILL START OF SAY, HERE'S THE QUESTION I WOULD LOAMACYIC TO ASK, HERE ARE THE KINDS OF DATA WE WOULD COLLECT TO ANSWER THOSE QUESTIONS AND A PROCESS TO SORT OF CODE THOSE SO THEY CAN BE FED INTO THE SCIENTIFIC PROTOCOL. >> OKAY, SO, MAYBE THIS IS SOMETHING FOR A FUTURE WORKSHOP? BUT I WOULD BE INTERESTED IN LOOKING AT WHAT SOME OF THE EXISTING USE CASES ARE TO ASK WHAT ARE THE SOCIAL ETHICAL LEGAL IMPLICATIONS OF THOSE STUDIES. >> SURE AND I DON'T KNOW, KELLEY AND THEM AREN'T HERE, WHEN WE HAVE A LIBRARY OF THOSE CASES, I DON'T THINK THEY'RE SECRET, I THE JUST DON'T THINK THEY'VE BEEN PUBLISHED. >> SO APPARENTLY THESE CASES ARE ONLINE NTHERE IS A PRINT OUT OF-- >> YEAH, THEY'RE ONLINE, I WILL MAKE SURE TO TRACK DOWN A LINK AND POPULARIZE THAT DURING THE EVENT BUT IT'S THROUGH THE RESEARCH HUB THAT JENNIFER IS SHOWING. >> SO WHAT I THINK I WILL DO IS JUST QUICKLY JUST SHOW IF YOU WANT TO LOOK AT, CONDITIONS, SO THIS AGAIN IS JUST MEDICAL CONCEPTS THAT HAVE BEEN PULLED FROM THE ELECTRONIC MEDICAL RECORDS. YOU CAN SEE THE TOP 10 CONDITIONS BY DESCENDING PARTICIPANT COUNTS ISSUES THE TOP 1 BEING PAIN, SO THAT IS SHOWING UP THE MOST TIMES IN THE PARTICIPANTS MEDICAL RECORDS, CAN YOU THEN GO DOWN AND GET A LITTLE MORE DETAIL, AGAIN LOOKING AT THE BREAK DOWNS BY SEX ASSIGNED AT BIRTH, AGE, AND THEN CAN YOU GO FURTHER INTO LOOKING AT THE SOURCES SO PAIN IS A VERY BROAD CATEGORY AND THERE'S LOTS OF DIFFERENT MEDICAL CONCEPTS THAT KIND OF FALL UNDER THAT LARGE CATEGORY OF PAIN SO YOU CAN JUST START LOOKING AT THE HIERARCHY AND SEEING HOW MANY PARTICIPANTS HAVE THESE DIFFERENT TYPES OF PAIN WITHIN THEIR MEDICAL RECORDS. THE NEXT THING REAL QUICK IS PHYSICAL MEASUREMENTS, AGAIN, YOU CAN LOOK AT BREAK DOWN BY MALE FEMALE AND OTHER, AND NUMBER OF PARTICIPANT WHO IS HAVE THESE SPECIFIC--IN THIS CASE, IT'S BLOOD PRESSURE, SYSTOLIC BLOOD PRESSURE, SO THEY HAVE 120 SYSTOLIC BLOOD PRESSURE READING AND THEN THE AGE WHEN THE PHYSICAL MEASUREMENTS WERE TAKEN SHOWN HERE. THE OTHER THING YOU CAN DO IF YOU DON'T WANT TO GO BY LOOKING AT THE LIST OF CONDITIONS, YOU CAN DO A SEARCH, SO LIKE HYPER TENSION, AND YOU CAN SEE THAT THERE ARE 59 CONDITIONS THAT FIT THAT SEARCH CRITERIA, AND AGAIN YOU CAN EXPLORE FURTHER, I'M NOT GOING TO SPEND TOO MUCH MORE TIME BECAUSE WE'RE GETTING CLOSE TO THE END HERE. SO THAT IS THE DATA THAT'S CURLY AVAILABLE IN THE RESEARCH--CURRENTLY AVAILABLE IN THE RESEARCH HUB OR DAT BROWSER, THE RESEARCH HUB IS LIKEAUR MAIN WEBSITE AND THE DATA BROWSER BEING THIS TOOL RIGHT HERE SO FEEL FREE TO PLEASE GO IN AND EXPLORE MORE, ESPECIALLY MIGHT BE USEFUL DURING THE BREAK OUT SESSIONS TO SEE WHAT ALL'S DATA IS IN THERE. >> YES. >> MAY I ASK A QUESTION, ALL OF THIS IS ABOUT ACCESS TO AGGREGATE DATA. >> YES. >> PEOPLE MADE REFERENCE TO RETURN OF RESULTS BUT NOBODY'S REALLY TALKED ABOUT ACCESS TO YOUR OWN INDIVIDUAL RAW DATA. SO, YOU KNOW FROM THE BEGINNING ALL OF THOSE DOCUMENTS HAVE COMMITTED BOTH TO RESPONSIBLE RETURN OF RESULTS AND ACCESS TO YOUR OWN DATA. SO CLEARLY THIS DOESN'T GIVE YOU ACCESS TO YOUR OWN DATA, HOW DO YOU GET THAT? >> THAT--OKAY, GO AHEAD. >> APOLOGIES FOR THE ACRONYM SOUP BUT WE HAVE LOTS OF DIFFERENT WORDS, THAT FORMERLY DOESN'T GO THROUGH THE DAILY BASIS AT RESEARCH CENTER, IT GOES THROUGH THE PARTICIPANT PORTAL WHICH IS A DIFFERENT TECHNOLOGY STACK, THIS IS PROVIDING ACCESS TO THE RESEARCHERS SO THE WAY IT WORKS NOW IF YOU WERE IN THE STUDY AND YOUR HEALTH RECORDS ARE LOADED IN, IF YOU WOULD SEE THEM, IN THE EHRs, YOUR SURVEY ANSWERS, THAT'S WHERE IT STARTS. >> YOU WOULD SEE YOUR ANSWERS RELATIVE TO OTHER AGGREGATE RESPONSES? >> AS THOSE FEATURES ROLL OUT, RIGHT? SO RIGHT NOW IT'S PRETTY, THE NICE WAY, THE MEDICAL MINUTES, RIGHT? >> I THINK THAT MIGHT BE COMING. AND THEN I THINK WITHIN THE PARTICIPANT PORTAL SOMETIMES CAN YOU SEE FOR SOME OF THE QUESTIONS, I BELIEVE, YOU CAN SEE HOW YOU COMPARE. >> IT'S CALLED THE COMPARATIVE INSIGHTS TOOL, I DON'T FINISH IT'S BEEN APPROVED BY THE IRB OR NOT, BUT THOSE COME OUT THROUGH A DIFFERENT STACK, A DIFFERENT STACK OF [INDISCERNIBLE] ISSUES AND A DIFFERENT TECHNOLOGY STACK, INCLUDING THE RIGHT TO EXPORT IS AM CANNING COUNSEL THE LINE AS WELL BUT WE HAVE TO FIGURE OUT THE INFORMING PROCESS TO DNA FOR 23 AND ME FOR EXAMPLE BECAUSE THOSE ARE ALL PLAUSIBLE USE CASES FOR WHAT'S COMING SO PART OF WHAT CAN BELICATED ABOUT GETTING INTO THE PROGRAM IS THE STEP WISE APPROACH OF THE FIRST VERSION AHAD PROACH IS GET YOU YOUR ANSWERS BACK, TO THE SURVEYS YOU TOOK, THE SECOND VERSION IS THE HEBLGHT RECORDS AND AT WHAT POINT WE FEED TO HAVE INFORMED CONSENT EXPERIENCES AND PERFORMING EXPERIENCES AND SO FORTH, THAT ALL RUNS THROUGH THE PARTIC PLAN TO ANALYZE BY AGE FACING STACK AND NOT THE RESEARCH FACING STACK MUCH. >> THAT MIGHT BE SOMETHING I DIDN'T MAKE CLEAR FROM THE BEGINNING AND AS THE DATA AND RESEARCH CENTER WE'RE REALLY JUST THERE TO TAKE IN THE DATA THAT THE PROGRAM IS COLLECTING THROUGH THESE VARIOUS SOURCES SUCH AS THE PARTICIPANT POETIC ARE THAL FOR THE PBI SURVEYS TO HARMONIZE DATA AND PUT IT IN FORMAT THAT CAN BE USED BY RESEARCHERS AND BY THE PUBLIC. SO WE'RE NOT REALLY THE 1S MAKING THE MAIN DECISIONS ON WHAT'S GOING TO BE INCLUDED AND WHAT'S NOT. >> YEAH, RELATED TO THAT, THROUGH--IS THERE ANY WAY FOR RESEARCHERS OR PEOPLE LIKE US OR WHAT WE'RE MEANT TO COMMENT ON TO INCLUDE METADATA LINKING THE PARTICIPANTS RESEARCH DATA THAT GO IN WITH THINGS LIKE IF THERE'S DIFFERENT CHOICES INFORMED CONSENT, WHICH 1S DID THEY CHOOSE OR IF THEY CHOSE TO DOWNLOAD DATA DID THEY CHOOSE TO, YOU KNOW, WHAT KINDS OF CHOICES THEY MADE, IS THERE METADATA THAT CAN GET LINKED TO ANY OF THESE OTHER DATA TYPES. >> I'M NOT A HUNDRED PERCENT SURE ON THAT BUT I THINK THERE WILL BE WAYS THAT YOU CAN DETERMINE WHICH VERSION OF A SURVEY PARTICIPANTS TOOK IN CASE THERE'S DIFFERENT VERSIONS THAT ROLL OUT OVER TIME. >> IN THEORY YES, THERE IS. BUT THAT'S ANOTHER THING, THAT'S ANOTHER REASON WE'RE COMING TOGETHER TODAY, WE WOULD LOVE TO HEAR FROM YOU GUYS, WELL WHAT IS IT OF ALL THIS METADATAA MAY BE COLLECTING AND NOT COLLECTING& AND SHOULD BE COLLECTING WHAT WOULD BE VALUABLE TO BE PROVIDING TO RESEARCHERS AS WELL. SO, YES. >> OKAY, SO I WILL GO AHEAD AND KEEP MOVING BECAUSE I THINK WE'RE GETTING CLOSE TO TIME, BUT SO WE TALKED ABOUT THE DATA TYPES THAT WE ALREADY HAVE, AND I WANT TO TOUCH ON SOME OF THE DATA TYPES THAT WE ARE EXPECTING TO INGEST INTO THE DATA AND RESEARCH CENTER, IN THE NEAR FUTURE, 1 OF WHICH IS THE FIT BIT DATA THAT YOU'VE HEARD MENTIONED EARLIER, SO WE HAVE THIS PROGRAM CALLED BRING YOUR OWN--THE PROGRAM HAS A PROGRAM CALLED BRING YOUR OWN DEVICE OR BYOD, SO IF YOU ALREADY HAVE A FIT BIT, CAN YOU LINK THAT DATA WITHIN THE PARTICIPANT PORTAL AND CURRENTLY THE PARTICIPANT TECHNOLOGY SYSTEM CENTER IS RECEIVING THAT DATA, AND THE DATA AND RESEARCH CENTER IS WORKING WITH THE PTSD TO GET THE DATA AND DETERMINE HOW WE'RE GOING TO PUT IT INTO THE DATA SET TO MAKE AVAILABLE FOR RESEARCHERS. ALSO, WORKING ON GETTING DATA FOR THE APPLE HEALTH KIT, AND EXTERNAL DATA SUCH AS MORTALITY DATA FROM THE NATIONAL DEATH INDEX AND CANCER REGISTRY DATA THROUGH THE NAACCR, OR SEAR PROGRAM. AND AS WE KNOW GENOMICS IS COMING IN THE NEAR TERM, CURRENTLY, THE GENOME CENTERS WERE AWARDED, I THINK LAST FALL AND THE DRC IS WORKING WITH THE GENOME CENTERS TO GET THAT WHOLE PROCESS OF UP AND RUNNING, OF GETTING THE BIOSAMPLES TO THE GENOME CENTERS, DOING THE GENOME TYPING AND THEN GETTING THAT DATA BACK TO THE DATA AND RESEARCH CENTER. IN ADDITION THE SALIVARY PILOT IS IN PROGRESS AND THAT IS ALSO WHERE SALIVARY KITS HAVE BEEN SENT OUT TO DIRECT VOLUNTEERS THAT LIVE OVER 50-MILES FROM A HEALTH PROVIDER ORGANIZATION WHERE THEY CAN'T GO TO DID DONATE BIOSPECIMENS AND SO IT'S A PILOT STUDY TO SEE IF THERE'S ANOTHER SOURCE OF D NA IN ORDER TO DO THE GEOTYPING AND LAB ASSAYS THAT ARE PROPOSE ARE H PA C1 C AND HEAVY METALS AND PESTICIDES SO WE TALKED ABOUT ALL THESE DIFFERENT DATA TYPES BUT WE DIDN'T TALK ABOUT HOW WE GET FROM POINT A TO POINT B OF LIKE DECIDE WHAG DATA TYPE WE WANT TO HAVE IT AVAILABLE FOR RESEARCHERS AND THIS IS A REALLY DETAILED LENGTHY PROCESS THAT STARTS WITH REQUIREMENTS GATHERING, SO THAT'S ANOTHER 1 OF THOSE LIKE USE CASES, REQUIREMENTS GATHERING PROJECT MANAGER TYPE SPEAK, BUT DETERMINING WHAT THE USE CASES ARE AND THEN HOW WE WILL GET THAT DATA IS IT GOING TO BE PARTICIPANT PORTAL, HEGHT PRO IN CAN WE GET IT FROM ELECTRONIC HEALTH RECORDS ONER LINKING DEVICES SUCH AS FIT BIT LIKE WE SAID AND SO THEN THE DRC WORKS WITH THESE DIFFERENT ENTITIES, THAT ARE PART OF THE ALL OF US CONSORTIUM TO DETERMINE HOW WE WILL GET THAT DATA LIKE IS IT API AND FIRE BUNKED EXPWEL HOW WE WILL WE GET THAT DATA AND TWEP THAT PROCESS, TESTING THE PROCESS, MAKING SURE THE SECURITIES IS ALL IN PLACE, AND FINALLY ONCE WE CAN GET THROUGH THAT WHOLE PROCESS AND GET THE DATA, THEN THAT DATA CAN BE RELEASED IN WHAT WE CALL THE RAW DATA REPOSITORY OR THE RDR, AND AS WE MENTION JUST A BIT AGO, THE RETURN OF INFORMATION IS GOING TO OCCUR THROUGH THE PARTICIPANT PORTAL AND COME STRAIGHT FROM THAT RAW DRATTA REPOSITORY. BUT THEN ALSO WITHIN THE DRC, THE RAW DATA HAS TO GO THROUGH THIS CURATION PROCESS, AND THIS IS WHERE WE'RE TAKING THE DATA, MAPPING IT, HARMONIZING IT, THERE'S THE DEVELOPMENT OF A PHASE 1 ETL PROCESS, TESTING, QA, QC, AND THEN DETERMINING WHETHER OR NOT THAT DATA NEEDS TO UNDERGO ANY PRIVACY METHODOLOGY LIKE [INDISCERNIBLE] TALKED ABOUT EARLIER SO THEN DEVELOPING THAT METHODOLOGY, DOING ANOTHER ROUND OF ETL AND MORE TESTING, MORE SECURITY AND ONCE THAT ALL HAS BEEN DONE THEN WE CAN RELEASE, WHAT WE'RE CALLING THE CURATED DAILY BASIS THEA REPOSITORY OR THE CDR AND SO THIS IS THE--SORRY, THIS IS THE--MAKE THAT GO AWAY. SO THIS IS THE DATA SOURCE FROM WHICH THE PUBLIC DATA BROWSER POOLS AND ALSO RESEARCHER WORK BENCH THAT WILL BECOMING THIS WINTER WILL PULL FROM AND THE CDR WILL BE UPDATED POTENTIALLY ON A QUARTERLY BASIS, THAT'S TO BE DETERMINED HOW OFTEN THAT WILL BE UPDATED THROUGHOUT THE YEAR AND THAT WILL THEN GO AND BE UPDATED, THE DATA WILL BE UPDATED ON THE PUBLIC DATA BROWSER AND ON THE WORK BENCH WHEN THE CDR IS UPDATED. SO WHEN WE LAUNCH THE RESEARCHER, JUST 1 SECOND--WHEN WE LAUNCH THE RESEARCHER WORK BENCH THIS WINTER, THESE ARE ROUHLY THE NUMBERS WE'RE EXPECTING TO HAVE IT LAUNCH SO PHYSICAL MEASUREMENTS OVER DATA FROM OVER 160,000 PARTICIPANTS, BASICS LIFESTYLE AND OVERALL HEALTH SURVEYS, FROM OVER 190,000, AND THREN THE NEXT SET OF 3 SURVEYS, PERSONALLY MEDICAL HISTORY, FAMILY MEDICAL AND FAMILY HEALTHCARE ACCESS OVER 30,000 AND THEN DATA FROM THE ELECTRONIC HELT RECORDS WE'RE ANTICIPATING TO BE OVER 110,000 PARTICIPANTS. AND THEN JUST TO GIVE LIKE A BIG OVER SLEW OF WHEN WE AND ECTOMYOSIN TO HAVE THESE DATA TYPES INCORPORATED INTO THE CDR, AS I POINTED OUT WE HAVE BASICS LIFESTYLE AND OVERALL HEALTH SURVEYS ALREADY IN THE CDR, HEALTHCARE ACCESS AND UTILIZATION, PERSONAL MEDICAL HISTORY AND FAMILY MEDICAL HISTORY ARE COMING VERY SOON, THE CDR HAS BEEN RELEASED INTERNALLY AND WE'RE CURRENTLY QCKING THAT AND THAT WILL BE AVAILABLE ON THE DAT BROWSER SOON, WE'RE HOPING TO BE ABLE TO INCORPORATE THE MORTALITY DATA LATE THERAPY AND WINTER, AND THEN GENOMICS DATA, WHICH INCLUDES THE GENOMICS FROM THE BLOOD BIOSPECIMENS AND ALSO FROM THE SALIVARY DNA PILOT, COMING IN Q2 OF 20, 20, MOVE MODULE DATA, ALSO Q2 OF 2020 AND THEN WE'RE PREDICTING Q-3 OF 2020 TO BE ABLE TO HAVE MENTAL HEALTH SURVEY RESULTS, EHR IMAGES, FIT BIT DATA, LAB ASSAY PILOT DATA, AND THEN FURTHER DOWN THE ROAD THE CANCER REGISTRY DATA. NOW ALL THESE DATES AND THE ORDER OF NEW DATA TYPES, IS SUBJECT TO CHANGE AND IT'S ALL JUST GUIDED BY THE PROGRAM PRIORITIZATION AND WHAT THEY DEEM TO BE A PRIORITY FOR THE DRC TO BE ABLE TO TAKE IN AND CURATE. AND I'M GOING TO GIVE A REALLY QUICK SNEAK PEEK OF THE RESEARCHER WORK BENCH SEE WE'VE ALREADY SHOWN THE PUBLIC SITE, YOU DON'T HAVE TO BE REGISTERED, ANYBODY CAN GO TO IT RIGHT NOW AND THEN DACIA COVERED THE WHOLE PASS PORT PROCESS THAT WILL ALLOW YOU TO GET INTO THE RESEARCHER WORK BENCH. SO THE RESEARCHER WORK BENCH WILL CONTAIN CUSTOM TOOLS FOR EXPLORING AND SELECTING SUBSETS OF THE AOU DATA AND WITHIN THE DATA TAB, SHOWN HERE, YOU WILL BE ABLE TO BUILD COHORTS, THE COHORT BUILDER IS INTUITIVE ASK ADVANCE TOOL FOR BUILDING CO HOOTERS, IT'S A POINT AND CLICK WHERE YOU ADD CRITERIA, SUCH AS DIMMOGRAPHIC CRITERIA, ICD 9 KOIDS AND MAYBE YOU ONLY WANT PARTICIPANTS THAT ANSWERED A SURVEY QUESTION IN A SPECIFIC WAY, YOU CAN POOL THOSE PARTIC PLAN TO ANALYZE BY AGES AND AS YOU'RE BUILDING YOUR COHORT, CAN YOU SEE ALSO THE BREAK DOWN OF PARTICIPANTS BY GENDER, AGE, RACE, ET CETERA. CONCEPT SETS ARE WHERE YOU CAN GO IN AND BUILD A SET OF MEDICAL CONCEPTS THAT YOU WOULD LIKE TO SEE ABOUT THE PARTICIPANTS IN YOUR COHORT, SO, YOU CAN SEE--SAY YOU WANT TO JUST KNOW EVERYBODY'S BLOOD PRESSURE, CAN YOU GO IN AND SELECT THE CONCEPT FOR BLOOD PRESSURE, AND YOU KNOW WHATEVER ELSE YOU WANT TO BUILD YOUR CONCEPT SET. THEN YOU MOVE INTO DATA SETS WHERE YOU WILL BE ABLE TO SELECT 1 OF THE COHORTS THAT YOU BUILT, THE CONCEPT SET YOU WANT TO ASSOCIATE WITH THRA COHORT, AND THEN YOU CAN GO THROUGH AND YOU CAN SELECT WHAT DIFFERENT COLUMNS YOU ACTUALLY WANT TO SEE FROM THE DATA TABLES. AND YOU'LL SEE A LITTLE BIT MORE IF YOU LOOK AT THE DAT DICTIONARY PACKETS THAT YOU'LL BE GETTING WHEN WE GO INTO THE WORKSHOPS AND I AM HAPPY TO ANSWER ANY QUESTIONS I CAN IN MORE DETAIL ABOUT THAT LATER IF YOU JUST WANT TO FIND ME. BECAUSE THE OMOP COMMON DATA MODEL IS COMPLICATED AND WE WILL PROVIDE RESOURCES THAT SHOULD HELP TO MAKE IT MORE UNDERSTANDABLE AND EASY TO USE. THEN ONCE YOU CREATE YOUR DATA SETS YOU WILL BE ABLE TO EXPORT THOSE TO A JUPIT NOTEBOOK, THIS IS WHERE DO YOU YOUR POWERFUL INTERACTIVE DATA NACIALTION SIS, USING COMMON PROGRAMMING LANGUAGES SUCH AS R OR PYTHON AND WE WILL HAVE A HELP DESK AVAILABLE FOR GENERAL AND TECHNICAL SUPPORT, COMMUNITY FORUMS, KNOWLEDGE BASE, WE'RE PRODUCING LOTS OF USER GUIDES, INSTRUCTIONAL VIDEOS, WORK SPACE TEMPLATE WORK SPACES WHERE YOU CAN GO THROUGH AND SEE END-TO-END ANALYSIS, LIKE HOW TO BUILD COHORTS OR CONCEPT SETS HOW TO BRING THAT ALTOGETHER AND WORK IN A JUPITER NOTEBOOK. AND THEN ALSO THE DATA DICTIONARY THAT I MENTIONED THAT WILL HELP TO MAKE THE OMOP COMMON DATA MODEL MORE AND OUR DATA MORE EASY TO WORK WITH. >> CAN YOU JUST CLARIFY IF THOSE TOOLS ARE THE SAME FOR THE RESTRICTED AND THE CONTROLS OR IS THIS ALL CONTROLLED. >> THIS IS ALL IN THE RESTRICTED STRICTED DATA TIER RIGHT NOW. MY UNDERSTANDING IS THAT THE TOOLS WILL BE THE SAME, BUT THE CDR, THEY PROBABLY WILL BE A DIFFERENT CDR OR SOMEHOW LIKE SOME OF THOSE-- >> BECAUSE A LOT OF CATEGORIES ARE GOING TO BE GENERALIZED. >> RIGHT. >> SO I MEAN YOU WON'T BE ABLE TO SELECT A LOT OF THOSE THINGS? , YEAH SO IT WILL HAVE TO BE A DIFFERENT CDR THAT WILL GO THROUGH A DIFFERENT ETL PIPELINE THAT GENERALIZE THOSE SPECIFIC CATEGORIES SO I THINK ONCE YOU GET INTO THE CONTROL TIER, YOU WILL HIT A DIFFERENT DATA SET. >> YES? >> I JUST WANT TO ASK WILL IT BE A FACILITY FOR PEOPLE IF THEY COME UP WITH THE PARTICULARLY INTERESTING COHORT OR A SECONDARY ANALYSIS TO REUPLOAD IT TO YOUR RESOURCE SO THAT SOMEONE ELSE COULD USE IT BECAUSE THEY CAN'T REALLY TAKE IT OUT. >> YES, I BELIEVE THAT IS A PLAN, WE WOULD LIKE TO HAVE RESEARCHERS BE ABLE TO SHARE LIKE THEIR INSIGHTS AND WHAT THEY'VE LEARNED BACK. I CAN'T ANSWER THAT SPECIFICALLY TO KNOW WHETHER OR NOT YOU WILL BE ABLE TO SHARE A COHORT, BUT YOU CERTAINLY CAN SHARE WORK SPACES AMONGST RESEARCHERS, SO ANYBODY ELSE THAT HAS--THAT'S REGISTERED TO TO USE THE RESEARCHER WORK BENCH,S YOU ARE ABLE TO SHARE A WORK SPACE WITH THAT PERSON. CAN YOU GO IN AND FIND THEIR E-MAIL, SHARE IT, IT WILL SHOW UP ON THEIR WORK BENCH WHEN THEY GO IN AND YOU'LL BE ABLE TO SEE THE COHORTS AND EVERYTHING THAT YOU'VE BUILT, SO CAN YOU SELECTIVELY DO THAT FOR SURE BUT I'M NOT SURE ABOUT--IT IF THERE WILL BE A POSSIBILITY TO GENERALLY SHARE THOSE. >> OKAY? [ APPLAUSE ]