>> GOOD MORNING, EVERYONE. THANK YOU FOR JOINING US. WELCOME TO THE 48th MEETING OF THE NIH ADVISORY COMMITTEE ON RESEARCH IN WOMEN'S HEALTH. THIS MEETING IS OPEN TO THE PUBLIC BROADCAST LIVE ON NIH VIDEOCAST NETWORK BEING RECORDED. IF YOU'RE NOT AWARE FOR THOSE GUESTS HERE IN THE ROOM, THE RESTROOMS ARE LOCATED AT EITHER END OF THE HALLWAY, THERE OOH CAFETERIA AVAILABLE ONE LEVEL UP NEXT TO MAIN ENTRANCE AND AS A REMINDER ALL COUNCIL MEMBERS VICE PRESIDENT PARTICIPATION ONE MEETING A YEAR PROVIDED WE HAVE ADVANCE NOTICE. NOW I WILL MOVE ON TO THE SGE REMINDER FOR EVERYONE. AS MEMBERS OF THE FEDERAL ADVISORY COMMITTEE YOUR SPECIAL GOVERNMENT EMPLOYEE WHICH MEANS YOU'RE SUBJECT TO THE SAME ETHICS RULES THAT APPLY TO GOVERNMENT EMPLOYEES ARE IN THE PAMPHLET, STANDARD OF EXECUTIVE BRANCH. YOU RECEIVED A COPY OF THIS DOCUMENT WHEN YOU WERE APPOINTED. AT EVERY MEETING WE WOULD LIKE TO REVIEW THESE STEPS WE TAKE AND PROCESS FOLLOW TO IDENTIFYND ADDRESS ANY CONFLICTS BETWEEN PUBLIC RESPONSIBILITIES AND YOUR PRIVATE INTERESTS. AS YOU KNOW BEFORE EVERY MEETING YOU PROVIDE A GREAT DEAL OF INFORMATION ABOUT YOUR PROFESSIONAL PERSONAL AND FINANCIAL INTERESTS. WE USE THIS INFORMATION AS FOUNDATION FOR ASSESSING WHETHER OR NOT YOU HAVE ANY REAL POTENTIAL OR APPARENT CONFLICT OF INTEREST THAT COULD COMPROMISE YOUR ABILITY TO BE OBJECTIVE IN GIVING ADVICE DURING OUR MEETINGS. IF THE NEED FOR YOUR INDIVIDUAL SERVICES OUTWEIGHS THE POTENTIAL CONFLICT OF INTEREST WE HAVE IDENTIFIED, WE WOULD ISSUE A WAIVER OF RECUSAL FROM A PARTICULAR PORTION OF THE MEETING. WE WAIVE CONFLICT OF INTEREST FOR GENERAL MATTER BECAUSE YOUR ABILITY TO BE OBJECTIVE WILL NOT BE AFFECTED BY FINANCIAL INTEREST. WE ALSO RELY A GREAT DEAL ON EACH OF YOU. NEED TO BE ATTENTIVE DURING THE MEETINGS TO THE POSSIBILITY AN ISSUE COULD ARISE THAT COULD EFFECT OR APPEAR TO EFFECT THE FINANCIAL INTEREST OF THE SPECIFIC SPARTY MATTER. IF THIS HAPPENS YOU WILL BE ASKED TO RECUSE YOURSELF FROM THAT PORTION OF THE MEETING. ADVANCE THE SLIDE PLEASE. I WOULD LIKE TO TAKE A MOMENT AND RECOGNIZE (INAUDIBLE) COMMITTEE MEMBERS. COLLEGE OF DENTISTRY AND DIRECTOR OF FLORIDA UNIVERSE PAIN RESEARCH AND INTERVENTION CENTER OF EXCELLENCE. HE'S INTERESTED IN INFLUENCE O SEX GENDER RACEETH IN IF I CAN GROUP AGE AND NAIL JEEZIC RESPONSES -- ANALGESIC RESPONSE, UNDERLYING MECHANISMS IN INDIVIDUALS DIFFERENCES IN PAIN. ALSO LIKE TO INTRODUCE YOU TO DR. STACY GELLER, THE G WILLIAM AARONS OBSTETRIC GUYOLOGY PROFESSOR IN THE DIVISION OF ACADEMIC INTERNAL MEDICINE, AT THE UNIVERSITY OF ILLINOIS, COLLEGE OF MEDICINE. SHE IS DIRECTOR USC CENTER FOR WOMEN AND GENDER NATIONAL CENTER OF EXCELLENCE FOR WOMEN'S HEALTH. DR. GELLER IS HEALTH SERVICES RESEARCHER IN EPIDEMIOLOGIST WITH EXPERTISE IN WOMEN'S HEALTH COMPLIMENTARY AND ALTERNATIVE MEDICINE, MATERNAL MORTALITY AND MORBIDITY. AND SHE'S NOT WITH US TODAY SHE'S ATTEND A MEETING WITH THE ILLINOIS MATERNAL MORTALITY REVIEW COMMITTEE WHICH SHE'S A FOUNDING MEMBER. ALSO LIKE TO INTRODUCE YOU TO DR. MARGARET MCCARTHY, PROFESSOR IN AND CHAIR OF DEPARTMENT OF PHARMACOLOGY AT THE UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE. DR. MCCARTHY IS A LONG STANDING INTEREST IN CELLULAR AND MOLECULAR MECHANISMS ESTABLISHING SEX DIFFERENCES IN BRAIN. SHE USES A COMBINED BEHAVIORAL MECHANISTIC APPROACH IN THE LABORATORY OF RAT UNDERSTAND BOTH NORMAL BRAIN DEVELOPMENT AND HOW THESE PROCESSES MIGHT GO SELECTIVELY AWRY IN MALES VERSUS FEMALES AN DISCOVERED NUMEROUS NOVEL SIGNALING PROCESSES ALONG THE WAY. DR. MCCARTHY IS PRESENTING AT A MEETING IN NEW YORK AND WILL JOIN US OVER THE PHONE AFTER LUNCH. FINALLY DR. ELAINE RIOS IS PRESIDENT AND CEO OF THE NATIONAL HISPANIC MEDICAL ASSOCIATION. AS WELL AS PRESIDENT OF NHMA NATIONAL HISPANIC HEALTH FOUNDATION AFFILIATEDD WITH THE ROBERT F. WAGNER GRADUATE SCHOOL OF PUBLIC SERVICE. NEW YORK UNIVERSITY WHERE SHE DIRECTS EDUCATIONAL RESEARCH ACTIVITIES. SHE IS CLINICALLY TRAINED IN INTERNAL MEDICINE AND EARNED MASTER OF SCIENCE IN PUBLIC HEALTH AT THE UCLA SCHOOL OF PUBLIC HEALTH. NOW WE'LL CONDUCT INTRODUCTIONS AROUND THE TABLE AND THOSE ON THE PHONE REMEMBER TO SPEAK INTO THE MICROPHONE, TURN YOUR MICROTONE ON, THE LITTLE RED BUTTON, STATE YOUR NAME, BEFORE SPEAKING AT ALL TIMES IF YOU WILL DURING THE MEETING THAT SO WITH NO FURTHER ADIEU, SHALL WE START AROUND THE TABLE? >> GOOD MORNING. MY NAME IS CAROL MASURI FROM YALE UNIVERSITY SCHOOL OF MEDICINE AND I AM DIRECTOR OF WOMEN'S HEALTH RESEARCH AT YALE WHICH IS A 20-YEAR-OLD RESEARCH PROGRAM DOING SCIENCE IN WOMEN'S HEALTH. >> HI. I'M SUSAN WOOD, I'M PROFESSOR OF HEALTH POLICY MANAGEMENT AT GEORGE WASHINGTON UNIVERSITY SCHOOL OF PUBLIC HEALTH. WHERE I BOTH TEACH WOMEN'S HEALTH AND LEAD JACOB INSTITUTE O WOMEN'S HEALTH PUBLISHING JOURNAL OF WOMEN HEALTH ISSUES CONDUCTING RESEARCH PRIMARILY ON FAMILY PLANNING AND REPRODUCTIVE HEALTH AT COMMUNITY HEALTH CENTERS. >> GOOD MORNING (INDISCERNIBLE) ASSOCIATE DIRECTOR FOR INTERDISCIPLINARY RESEARCH AT OFFICE OF RESEARCH AND WOMEN'S HEALTH. >> GOOD MORNING, TO EVERYONE. MARGARET BEVINS ASSOCIATE DIRECTOR CLINICAL RESEARCH WITH ORWH. >> GOOD MORNING. I'M ASSOCIATE VICE PRESIDENT FOR RESEARCH IN ECONOMIC DEVELOPMENT AT THE GEORGIA STATE UNIVERSITY AND PROFESSOR OF NEUROSCIENCE. I STUDY SEX DIFFERENCES IN THE BRAIN, ASKING QUESTIONS HOW YOU GET THEM, ONCE THERE WHAT DO THEY MEAN FOR YOU IN HEALTH AND DISEASE. >> GOOD MORNING. I MICHELLE ROBINSON, I'M INTERIM DEAN OF UNIVERSITY OF ALABAMA SCHOOL OF DENTISTRY. >> HI. ROGER FILLINGIM DIRECTOR OF PAIN RESEARCH AND INTERVENTION CENTER OF EXCELLENCE AT THE UNIVERSITY OF FLORIDA. >> GOOD MORNING. SAFRA CLEAN, ASSOCIATE -- KLINE, ASSOCIATE PROFESSOR AT JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH. I CO-DIRECT THE JOHNS HOPKINS CENTER FOR WOMEN'S HEALTH SEX AND GENDER RESEARCH. >> GOOD MORNING. I'M NEAL (INAUDIBLE) OBSTETRICIAN AND HEALTH SYSTEMS SCIENTIST HARVARD MEDICAL SCHOOL AND MY WORK FOCUSES ON IMPROVING WELL BEING OF OTHERS. >> NOEL, MEDICAL DIRECTOR PROFESSOR OF THE BARBARA STREISAND WOMEN'S HEART CENTER CEDAR SINAI MEDICAL CENTER LOS ANGELES. WE DO INTERDISCIPLINARY RESEARCH IN WOMEN'S HEALTH REGARDING THE LEADING KILLER OF WOMEN, CARDIOVASCULAR DISEASE BUT THAT'S STEMS A LOT OF OTHER THINGS, BRAIN, ADVERSE PREGNANCY OUTCOMES, ET CETERA. >> GOOD MORNING. I'M MARSHA STEFANI, STANFORD SCHOOL OF MEDICINE, PROFESSOR OF MED SEASON AT THE RESEARCH CENTER, OBSTETRICS AND GYNECOLOGY AND DIRECTOR OF THE STANFORD WOMEN'S HEALTH AND SEX DIFFERENCES IN MEDICINE CENTER. >> GOOD MORNING. I'M RACHEL JOHNS, ASSOCIATE PROFESSOR AT SCHOOL OF NURSING NORTH EASTERN UNIVERSITY AND FACULTY SCHOLAR INSTITUTE ON URBAN HEALTH RESEARCH IN PRACTICE AND MY WE ARE CURRENTLY CONDUCTING CLINICAL TRIAL ON AGE PREVENTION IN URBAN WOMEN USING ONLINE VIDEO INTERVENTIONS. >> JUDY REAGAN STEIN PROFESSOR UNIVERSITY OF COLORADO SCHOOL OF MEDICINE, DIRECTOR FOR CENTER ON WOMEN RESEARCH. MANY I RESEARCH IS SEX DIFFERENCES IN AND CARDIOVASCULAR CONSEQUENCES OF TYPE 2 DIABETES BUT OUR CENTER IS VERY INTERDISCIPLINARY WAY ACROSS MANY FIELDS. EXCITING DEVELOPMENTS ARE GOING ON NOW AS WE PSYCHIATRY DR. NEAL EPPERSON VERY INVOLVED IN SEX DIFFERENCES AS WELL AS THE HEAD OF OBGYN, SO WE HAVE BEEN CHARGED WITH PUTTING SOMETHING TOGETHER. I'M EXCITED ABOUT IT. >> SHARON HUNTER, I'M ASSOCIATE DIRECT FOR FOR BASIC AND TRANSLATIONAL RESEARCH. ORWH. >> GOOD MORNING, EVERYONE. I'M -- ASSOCIATE DIRECTOR FOR SCIENCE POLICY PLANNING AND ANALYSIS AT OFFICE OF RESEARCH ON WOMEN'S HEALTH. (OFF MIC) >> I ONLY DAVID PAGE, I'M DAVID PAGE, BIOLOGY PROFESSOR AT MIT AND DIRECTOR FOR MEDICAL RESEARCH, MY RESEARCH FOCUS ON THE GENETIC DIFFERENCES BETWEEN MALES AND FEMALES. >> GOOD MORNING, I'M ALLISON MCGREGOR ASSOCIATE PROFESSOR EMERGENCY MEDICINE AT MEDICAL SCHOOL OF BROWN UNIVERSITY. CO-FOUNDER AND DIRECTOR FOR THE DIVISION OF SEX AND GENDER IN EMERGENCY MEDICINE AT BROWN WHERE WE STUDY SEX DIFFERENCES IN HEALTHCARE DISPARITIES IN EMERGENT CONDITIONS. >> GOOD MORNING, EVERYONE. I'M SO EXCITED TO SEE YOU ALL HERE. JANINE CLAYTON AS YOU KNOW. I'M REALLY THRILLED TO BE WELCOMING YOU TO THE 48th MEETING OF THIS NIH ADVISORY COMMITTEE ON RESEARCH WOMEN'S HEALTH. WE HAVE A FANTASTIC LINEUP FOR YOU TODAY. I'M REALLY LOOKING FORWARD TO OUR DISCUSSIONS. >> THANK YOU ALL. ONE HOUSEKEEPING ITEM. THE MINUTES FROM THE OCTOBER 23RD AND FEBRUARY MEETINGS WERE POSTED ON THE ORWRH WEBSITE, THE LINK WAS SENT TO Y'ALL FOR REFERENCE. IS THERE A MOTION ON THE TABLE TO ACCEPT THE OCTOBER 23RD, 2018 MINUTES AS WRITTEN? >> IS THERE A SECOND? THANK YOU. ALL IN FAVOR? THANKS. THE MOTION IS PASSED AND MINUTES WERE ACCEPTED. NOW I WILL HAVE THE HONOR AND PRIVILEGE TO TURN THE MEETING OVER TO DR. CLAYTON. >> GOOD MORNING, EVERYONE THIS IS ONE OF MY FAVORITE THINGS TO DO, TO TELL YOU ABOUT THE AMAZING WORK THE TEAM ORWH IS UNDERTAKING SINCE WE LAST MET. AND I HOPE YOU WILL BE AS IMPRESSED ADS I AM WITH THIS INCREDIBLE AMOUNT OF WORK THAT REALLY THIS TEAM HAS DONE. WE ALWAYS LIKE TO SHARE WITH YOU INFORMATION ABOUT NEW WOMEN LEADERS AND NEW INSTITUTE LEADERS GENERALLY BUT WE ARE ESPECIALLY EXCITED TO SHARE WITH YOU THE NEW DIRECTOR OF THE CENTER FOR SCIENTIFIC REVIEW, DR. BURNS AND THE NEW DEPUTY DIRECTOR FOR NCATS, NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES, DR. JONIE RUDDER. IN ADDITION DR. LARRY TABAK CREATED AD NEW POSITION, ASSOCIATE DEPUTY DIRECTOR OF NIH AND DR. TARA SWEFT ASSUMED THAT ROLE SO YOU WILL HEAR MORE ABOUT THEM. THIS IS THE PICTURE OF THE FOLKS THAT DO ALL THE HARD WORK. THIS IS OUR WEAR RED PHOTO WE TAKE EVERY YEAR AND THERE'S AN AMAZING AMOUNT OF EFFORT BEING DONE BY BOTH OUR FEDERAL AND CONTRACT STAFF THAT ARE DEVOTED TO ADVANCING WOMEN'S HEALTH AND I LIKE TO ACKNOWLEDGE THEM RIGHT UP FRONT BECAUSE THEY DID ALL THE WORK YOU WILL HEAR ABOUT. SO WE'RE IN APRIL. I HAVE GOT MY SPRING COLORS ON. AND TRYING TO MAKE SURE WE GET SOME WARM WEATHER CONTINUING. IT WAS LOVELY YESTERDAY. APRIL IS NATIONAL MINORITY HEALTH MONTH. THIS TEAM THEME IS ACTIVE AND HEALTHY. IT'S A APPROPRIATE TIME FOR US TO REMEMBER SOME OF THE THINGS THAT SOME OF THE DATA, DISTURBING DATA THAT REALLY SPEAK TO THE FACT THAT WE HAVE TO ADDRESS HEALTH IN A WAY THAT ADDRESSES BOTH SEX GENDER AN RACE ETHNICITY SIMULTANEOUSLY. SO WE LOOK AT THIS DATA ON MATERNAL MORTALITY. YOU CAN SEE NON-HISPANIC BLACKS TWO DIFFERENT TIME POINTS HAVE MORTALITY RATES PER HUNDRED THOUSAND THAT FAR EXCEED THOSE OF NON-HISPANIC WHITE AND HISPANIC WOMEN. VERY DISTURBING IN ANY CASE. IN TERMS OF MATERNAL MORBIDITY, CASES OF SEVERE MATERNAL MORBIDITY ARE HIGHLIGHTED HERE FOR 10,000 DELIVERIES. AGAIN, VERY SAME PATTERN PREVAILS AND WHAT'S WORSE, THIS IS GETTING WORSE FOR EVERYBODY. SO WE STILL HAVE WORK TO DO IN THIS SPACE. THIS WEEK COMING UP HAS BEEN RECOGNIZED AS BLACK MATERNAL HEALTH WEEK BY VARIETY OF ORGANIZATIONS AND ENTITIES. AND I WILL DRAW YOUR ATTENTION TO ONE OF THEM. A GROUP CALLED BLACK MATTER ALLIANCE. SO YOU WILL SEE ON SOCIAL MEDIA ATTENTION TO THESE ISSUES. YOU ALSO HAVE SEEN IN THE LITERATURE THE SCIENTIFIC LITERATURE INCREDIBLE AMOUNT OF WORK THAT IS COMING OUT REALLY FEATURING MATERNAL MORTALITY AND MORBIDITY, WE SOMETIMES CALL MM AND M WHICH IS ASSOCIATED WITH HUGE ARRAY OF RISK FACTORS. AND ALSO INFLUENCED BY SOCIAL DETERMINANTS OF HEALTH AS WELL AS STRUCTURAL AND INSTITUTIONAL ISSUES THAT WE MUST ADDRESS. SO IN THE U.S., THIS DATA ON THE LEFT IS FROM AN ACOG COMMITTEE PREGNANCY RELATED DEATHS IN THE U.S., YOU CAN SEE HEMORRHAGE AND CARDIOVASCULAR AND CORONARY CONDITIONS ARE PRETTY MUCH TIED FOR THOSE LEADING CAUSES OF DEATH THAT WE HAVE OBGYNs IN THE ROOM SO I WON'T BELABOR THIS POINT JUST TO HIGHLIGHT THOUGH THAT 70% OF THOSE PREGNANCY RELATED HEMORRHAGE DEATHS ARE PREVENTABLE. THAT'S THE KEY POINT. THE OTHER POINT 68.2% OF PREGNANCY RELATED DEATHS FROM CARDIOVASCULAR AND CORONARY CONDITIONS ARE ALSO PREVENTABLE SO WE HAVE TO DO BETTER. THE MAP ON THE RIGHT HIGHLIGHTS CHANGE IN MATERNAL MORTALITY BY STATE. ALL YOU NEED TO KNOW IS THOSE DARKER STATES HAVE A LARGER CHANGE AND THE CHANGE IS NOT IN A GOOD DIRECTION, IT'S WORSENING. SO AT NIH AS YOU CAN IMAGINE THERE IS BROAD INTEREST IN MATERNAL MORTALITY AND MORBIDITY, WE BROUGHT IT TO THE COORDINATING RESEARCH ON WOMEN'S HEALTH I'M PRIVILEGED TO CHAIR AND RECENTLY WE HAD PRESENTATIONS ON WORK BEING CONDUCTED BY THESE INSTITUTES RELATED TO MATERNAL MORTALITY AND MORBIDITY. JUST EARLIER THIS WEEK THE EUNICE KENNEDY SHRIVER CHILD HEALTH AND HUM DEVELOPMENT HOSTED A COMMUNITY ENGAGEMENT FORUM ON IMPROVING PATERNAL WEALTH -- MATERNAL HEALTH HIGHLIGHTING SOME OF THE ISSUES FROM D.C. WE SELECTED MATERNAL HEALTH AS THE TOPIC THAT WE ARE GOING TO FOCUS ON IN THIS YEAR'S VIVIAN PENN SYMPOSIUM, THE TITLE, IMPROVING MATERNAL HEALTH MIND THE NUMBERS, WE H -- MIND THE NUMBERS. WE -- BEHIND THE NUMBERS. WE WILL HEAR FROM A VARIETY OF SPEAKERS, WE WILL HEAR FROM THE PRESIDENT OF ACOG. WE ALSO HAVE EXCITING NEW RESOURCES ANNOUNCING AT THAT TIME. BUT I JUST WANTED TO GIVE YOU GUYS A LITTLE TEASER. SO THAT YOU WILL TUNE IN AND SEE NEW CONTENT ON OUR WEB PAGE THAT WILL RELEASING ON THAT DAY. ALSO WANT TO PUT THE NEW TRANS-NIH STRATEGIC PLAN WHICH AGAIN I WANT TO THANK YOU AND ADVISORY COMMITTEE WORKING WITH US TO DEVELOP THIS PLAN TO COVER ALL THE INSTITUTES AND CENTER AND BE A GUIDE POST FOR US TO ADVANCE SCIENCE FOR HEALTH OF WOMEN, DR. COLLINS HIGHLIGHTED THE ROLE OF THE PLAN AND ALSO ITS PLACE IN INTEGRATING RESEARCH TO IMPROVE THE HEALTH OF WOMEN IN THEREFORE THE NATION AND HIS REMARKS IN THE OPENING OF HIS PLAN. THIS IS OUR MAP WHERE WE ARE GOING SO I PUT IT UP FRONT TO REMIND US THIS IS OUR GUIDE. THANK YOU AGAIN. SO THE FOUR MAJOR AREAS I WILL COVER IN MY REMAINING REMARKS ARE COLLABORATIONS, RESEARCH PROGRAMS WE LIKE TO GIVE UPDATE ON THOSE WOMEN IN BIOMEDICAL CAREERS AND BUILDING CONNECTIONS. SO I DON'T THINK THAT WE CAN TALK ABOUT ANYTHING RELATED TO THE HEALTH OF WOMEN WITHOUT COMMENTING ON THE CURRENT OPIOID PUBLIC HEALTH CRISIS. THIS SLIDE SHOWS TRENDS IN DRUG USE AMONG DELIVERING WOMEN. YOU CAN SEE AT TOP THAT IS OPIOID USE IN RURAL LOCATIONS FOLLOWED BY OPIOID USE IN ALL COUNTIES AND AMPHETAMINES. INCREDIBLE INCREASE IN RATE THERE, VERY DISTURBING AND IS A CRITICAL ISSUE FOR THE HEALTH OF WOMEN AND MOTHERS. IF YOU LOOK AT ALL CAUSE MORTALITY ON THE TOP RIGHT YOU CAN SEE CAN YOU SEE THIS MOUSE? GREAT. ALL CAUSE MORTALITY, THIS IS THE DATA FOR NON-HISPANIC BLACKS. THIS IS NON-HISPANIC WHITES AND BECAUSE OF THE PREPONDERANCE DIFFERENT IN NUMBER THIS IS THE TOTAL. BUT I WANT TO DRAW YOUR ATTENTION TO THIS DATA. THIS IS OPIOID RELATED MATERNAL MORTALITY. THAT IS VERY DISTURBING. SO CLEARLY WE HAVE MUCH WORK TO DO IN THAT SPACE AND YOU WILL HEAR MORE ABOUT THAT LATER TODAY. IN TERMS OF THE NIH STRATEGY TO ADDRESS THE OPIOID EPIDEMIC, I'M SURE YOU ARE AWARE ABOUT THE HELPING TO END ADDICTION LONG TERM OR HEAL INITIATIVE WHICH IS A TRANSAGENCY EFFORT TO ADVANCE SCIENTIFIC SOLUTIONS TO THIS CRISIS. IT HAS MULTIPLE COMPONENTS, FIRST BEING BASIC SCIENCE RESEARCH ON PAIN AND ADDICTION. YOU CAN'T WORK ON ADDICTION WITHOUT UNDERSTANDING PAIN SINCE THAT'S CLEARLY THE PATHWAY TO ADDICTION IN MANY CASES. IMPLEMENTATION SCIENCE TO DEVELOP AND TEST TREATMENT MODELS IN REAL WORLD SITUATIONS. RESEARCH TO INTEGRATE BEHAVIORAL INTERVENTIONS AND MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDER AND THEN DEVELOPMENT OF NON-ADDICTIVE PAIN TREATMENT SO WE CAN GET INTO A DIFFERENT POSITION AND ADDRESS THESE ISSUES AND PREVENT ADDICTION FROM OCCURRING IN THE FIRST PLACE BY EFFECTIVELY TREATING PAIN. IT'S REALLY MY PLEASURE TO SHARE WITH YOU THAT DR. NOVA VOLKOW, DIRECTOR OF NATIONAL INSTITUTE ON DRUG ABUSE WILL BE GIVING A TALK AND UPDATING YOU ON HER EFFORTS AT NIDA TO ADDRESS THESE ISSUES. I'M ALSO EXCITED TO SHARE WITH YOU WE WERE ABLE TO EFFECTIVELY SIGN ON TO 14 RECENT HEAL FUNDING OPPORTUNITIES ANNOUNCEMENTS AND HERE ARE SOME OF THE HIGHLIGHTED FOR YOU HERE. I WILL HIGHLIGHT -- SPOTLIGHT ONE OF THEM HERE, HEALTHY BRAIN AND CHILD DEVELOPMENT IF YOU CAN SEE ON THE FAR RIGHT WE WERE ABLE THROUGH THIS COLLABORATION TO HAVE LANGUAGE RELATED TO THE IMPORTANCE OF SEX AND GENDER DIFFERENCES INCLUDED IN THAT FUNDING OPPORTUNITY ANNOUNCEMENT SO I WANTED TO GIVE YOU A TEST OF WHAT THAT LANGUAGE LOOKS LIKE WHEN WE COLLABORATE WITH OUR INSTITUTE AND CENTER PARTNERS IN THAT WAY. HERE YOU CAN SEE THAT IN THE HEALTHY BRAIN AND CHILD DEVELOPMENT INITIATIVE, WE HIGH LIGHT THE HIGHER PREVALENCE OF PAIN DISORDERS IN WOMEN, WE HIGHLIGHT THE GREATER SENSITIVITY IN FEMALES TO PAIN, AND WE PUT FORWARD THE CRUCIAL NEED TO INCLUDE WOMEN IN PAIN AND OPIOID RELATED RESEARCH. IN ADDITION, WE PUT FORWARD THE NOTION OF INTEGRATING IN A PURPOSEFUL WAY ACCOUNTING FOR SABB, AND LIFE COURSE PERSPECTIVE. SO WE HAVE ALL OUR MAJOR PRIORITIES THERE TO FILL OUR GAPS AND INFORM MORE EFFECTIVE PERSONALIZED APPROACHES TO IMPROVE THE HEALTH FOR WOMEN AND MEN. DR. REBECCA BAKER HAS RECENTLY BEEN NAMED THE DIRECTOR OF THE HEAL OFFICE WHICH IS NOW PART OF THE NIH OFFICE OF THE DIRECTOR. ON MARCH 13, THE FEDERAL CHARTER FOR TASK FORCE ON RESEARCH SPECIFIC TO PREGNANT WOMEN AND LACTATING WOMEN WAS RENEWED FOR TWO YEARS. DR. DIANA BIANCHI HAS BEEN CHAIRING THAT EFFORT, IT WAS CREATE BY THE 21st CENTURY CURES ACT, HAS BROAD MEMBERSHIP, INCLUDING ORWH AND CREATED A REPORT WITH 15 RECOMMENDATIONS. I WOULD REALLY COMMEND YOU TO LOOK AT THAT URL, THAT WEBSITE THAT HAS ALL THOSE 15 RECOMMENDATIONS, I'M GOING TO RESTATE A FEW SPECIFICALLY FOR YOU. DESIGNING RESEARCH TO INCLUDE PREGNANT AND NURSING WOMEN UNLESS SCIENTIFICKEDLY JUSTIFIED NOT TO DO SO, THEY ARE WORKING TO PUT FORWARD THE NOTION THIS SHOULD BE A DEFAULT, THAT WE HAVE TO STOP JUST DEFAULT EXCLUDING THEM AND MOVE TO A DEFAULT OF INCLUDING THEM IN, EVEN PREGNANT WOMEN AS APPROPRIATE UNLESS SCIENTIFICALLY JUSTIFIED NOT TO DO SO. EXPANDING THE WORK FORCE OF CLINICIANS AND RESEARCHERS WITH EXPERTISE IN THIS SPACE. INCLUDING LACTATION PHARMACOLOGY AND THEN REMOVING REGULATORY BARRIERS, THAT AUTOMATICALLY EXCLUDE WOMEN AND LACTATING WOMEN FROM RESEARCH IN SOME CASES. THIS IS REALLY VERY TIMELY BECAUSE THESE TWO PUBLICATIONS JUST CAME OUT IN THE NEW ENGLAND JOURNAL OF MEDICINE, ONE ENTITLED PHARMACOLOGIC RESEARCH IN PREGNANT WOMEN, TIME TO GET IT RIGHT. IS IT FAITH, MANY UNANSWERED QUESTIONS ABOUT MEDICATIONS AND BREAST FEEDING. IS IT SAFE. SO I'LL GO ON TO TALK TO YOU ABOUT AMAZING RESEARCH BEING DONE BY FOLKS AROUND THE WORLD ORWH IS PRIVILEGED TO SUPPORT IN COLLABORATION WITH NIH INSTITUTE AND CENTER PARTNERS. JUST TO ORIENT YOU SO YOU UNDERSTAND RESEARCH I'M TALKING ABOUT GOING FORWARD, I WOULD LIKE TO SHARE WITH YOU HOW WE HAVE ALLOCATED THESE FUNDS OVER THE LAST FISCAL YEAR. YOU CAN SEE THE BIRCH PROGRAM ON THE TOP RIGHT. THE YOUTH -- HERE, UNDERSTUDIED UNDERREPORTED UNDER-REPRESENTED WOMEN HERE, SEX AND GENDER ADMINISTRATIVE SUPPLEMENTS HERE, OUR NEW SCORE PROGRAM, R-56. THIS LARGE PART OF PIE WHICH IS RELATED TO CO-FUNDING RESEARCH LED BY OTHER INSTITUTES AND CENTERS. RELATED TO THE HEALTH OF WOMEN. I WILL GO OVER EACH OF THESE AND PROVIDE YOU A SPOTLIGHT FOR EACH OF THEM. YOU CAN ALSO SEE THERE HASN'T BEEN A REAL CHANGE IN OUR ABILITY TO BE ABLE TO DO MORE AND SO THAT HAS BEEN PARTICULARLY CHALLENGING AS WE TRY TO LEVERAGE THOSE RESOURCES EFFECTIVELY. SO THE FIRST IS THE BIRCH PROGRAM, ONE OF OUR SIGNATURE PROGRAMS AS YOU KNOW, BUILDING INTERDISCIPLINARY RESEARCH CAREERS IN WOMEN'S HEALTH USING A K 12 MECHANISM, THE 12 BUNCH PROGRAMS AROUND THE U.S., HERE ARE THE PARTNERS ON THE RIGHT. WE WERE HAD RECENTLY HAD A MEETING WHERE WE HAD OUR BIRCH PROGRAM MEETING AND HAD PRESENTATIONS FROM SCHOLARS, PIs INTRODUCE THEM WHICH IS VERY NICE WAY TO HIGHLIGHT THE ROLE FOR MENTORED CAREER DEVELOPMENT AWARD. THAT'S A KEY COMPONENT, YOU CAN SEE THE RANGE OF TOPICS HIGHLIGHTED AND THE REPRESENTED ORGANIZATIONS AROUND THE U.S.. WIDE RANGE OF TOPICS. VIDEOCAST IS AVAILABLE AND I'M THRILLED TO TELL YOU THE BIRCH RFA WAS PUBLISHED IN THE NIH GUIDE APRIL 8. WE ARE EXPECTING APPLICATIONS. BY MAY 29. SPREAD THE WORD. HERE IS BREAKDOWN OF THE INSTITUTES AND CENTERS WITH WHOM WE CO-FUNDED RESEARCH, AS YOU KNOW WITHOUT DIRECT GRANT MAKING AUTHORITY PARTNER WITH INSTITUTES AND CENTERS IN VIRTUALLY EVERYTHING WE DO. NICHD IS IN THE LEAD BUT I WANT TO HIGHLIGHT FOR YOU BECAUSE NICHD ADMINISTERS THE BIRCH PROGRAM AND IS A PARTNER WITH US ON THE BIRCH PROGRAM, LARGE PART OF THAT IS RELATED TO THE BIRCH PROGRAM SPECIFICALLY. YOU CAN SEE THE OTHER ICs ROUNDING OUT THE TOP THERE. IF WE REMOVE B IRCH IT'S EASIER THE SEE WHICH ARE THE INSTITUTES AND CENTERS THAT WE ARE SUPPORTING MOST NIDDK, NIDA, AGING INSTITUTE AND NHLBI. NCCH NIDA WERE IN THE TOP GROUP. I WILL GIVE YOU MORE DETAILS ABOUT SOME OF THOSE AS THEY GO FORWARD. HERE IS THE BREAKDOWN OF OUR SIGNATURE PROGRAMS. AND EFFORTS FOR FY 18. THE SPECIALIZED CENTERS OF RESEARCH EXCELLENCE NEW SCORE PROGRAM WE HAVE THREE PARTNERING ICs THIS YEAR AND YOU CAN SEE THE DATA IN TERMS OF THE AMOUNT OF SUPPORT, NUMBER OF ICs AND PARTICULAR ICs WE WORKED ON THE PROGRAM WILL HIGHLIGHT FOR YOU. WE DO TRY TO PARTNER BROADLY ADS MUCH ADS POSSIBLE AND WE HAVE ALMOST ALL ICs REPRESENTED HERE FROM FY 18 IN TERMS OF PARTNERSHIP. I WOULD LIKE TO SPOTLIGHT INVESTIGATOR FROM THE OTHER IC CO-FUND CATEGORY AND INSTITUTES AND CENTERS CAN REQUEST CO-FUNDING OF THEIR RESEARCH RESEARCH THEY SUPPORT THROUGH CO-FUNDING PORTAL CREATED. IT CAN BE BASIC RESEARCH PRE-CLINICAL RESEARCH, ANY TYPE RESEARCH ALIGNED WITH TRANS-NIH STRATEGIC PLAN FOR ADVANCING SCIENCE FOR HEALTH OF WOMEN. HAS TO ADDRESS A GAP THAT WE ARE FOCUSED ON. I'M HIGHLIGHTING STEVEN PATRICK, EARLY STAGE INVESTIGATOR WORKING ON IMPROVING ACCESS TO TREATMENT% FOR WOMEN WITH OPIOID USE DISORDER. THEY ARE DOING A FIELD EXPERIMENT. WHERE THEY ARE SENDING OUT SIMULATED WOMEN PATIENTS, REPRODUCTIVE AGE AND INTO RANDOMLY SELECTED OUTPATIENT BUPRENORPHINE PROVIDERS AND OPIOID TREATMENT PROGRAMS IN TEN STATES THAT HAVE VARYING POLICIES. SO THEY ARE TRYING TO FIND OUT ARE PREGNANT WOMEN WITH OPIOID USE DISORDER MORE LIKELY TO HAVE TROUBLE ACCESSING OPIOID AGONIST TREATMENT, FOR EXAMPLE, ISSUES RELATED TO OTHER POLICIES AND INSURANCE SO HERE IS ONE WAY THAT WE ARE ADVANCING THIS PARTICULAR ISSUE WHICH I HIGHLIGHTED FOR YOU AT THE BEGINNING, BY CO-FUNDING RESEARCH SUPPORTED BY INSTITUTE AND IN THIS CASE EARLY STAGE INVESTIGATOR. WHAT ABOUT THE R 56 PROGRAM? THIS IS A PROGRAM DESIGNED TO PROVIDE FUNDING TO INVESTIGATOR TO INCREASE THE LIKELIHOOD OF SUCCESSFUL SUBSEQUENT RPG AND I WILL HIGHLIGHT ON THE RIGHT THERE THE DATA WE LOOKED AT. LOOKING AT -- THIS IS A COLLABORATION WITH OTHER DPKPSI OFFICES, THE OFFICE OF AIDS RESEARCH, AND HERE WHEN WE LOOK AT FOLLOWING WITHIN THE LAST TWO YEARS FOLLOWING FY 16 GRANTEES WHO RECEIVED R 56 FUNDS, 57% OF THOSE WERE FOUND TO HAVE GONE TO OBTAIN AN RO1 ON THE SAME OR CLOSELY RELATED TOPICS. SO THAT'S EXACTLY WHAT THIS PROGRAM IS DESIGNED TO DO. I WOULD LIKE TO FEATURE DR. TONDA HUGHS AT COLUMBIA SCHOOL OF NURSING WORKING ON IMPACT OF SUPPORTIVE POLICIES ALREADY STRESS DRINKING AND HEALTH AMONG SEXUAL MINORITY WOMEN. HERE SPECIFIC AIMES ARE HIGHLIGHTED HERE. SHE FEATURED THE ORWH R 56 FUNDING IN HER PUBLICATION SO WE CAN SEE WHERE THAT WORK WAS BENEFICIAL AND SO THAT'S ONE PIECE OF INFORMATION I WANT TO HIGHLIGHT FOR YOU AS WELL. SINCE THE SCORE PROGRAMS WITHOUT AN E STARTED IN FISCAL YEAR 2002, NIH HAS INVESTED MORE THAN $180 MILLION IN SPECIALIZED CENTERS OF RESEARCH ON SEX DIFFERENCES. AS YOU KNOW, THIS IS THE ONLY NIH DISEASE AGNOSTIC TRANS-NIH DISEASE AGNOSTIC SEX DIFFERENCES FUNDING OPPORTUNITY. NOW WITH SCORE WITH AN E WE ARE SUPPORTED BY A COOPERATIVE AGREEMENT, IT WAS A P 50, WE HAVE A NEW CAREER ENHANCEMENT CORE. SO I WANT TO HIGHLIGHT FOR YOU THIS MULTI-PI AWARD AT EMORY WITH DR. HADAAD. THEY IN THEIR EMORY CENTER SPECIALIZED CENTERS OF SEX DIFFERENCES THEY HAVE THREE PROJECTS EXPLORING HIV INDUCED IMMUNE ACTIVATION AND CHRONIC INFLAMMATION. THEY ARE ALSO LOOKING AT ESTROGEN INSUFFICIENCY IN WOMEN WITH HIV AND HAVE THOSE THREE PROJECTS THAT I HIGHLIGHTED FOR YOU HERE. SO HERE IS ONE EXAMPLE OF ONE OF THE NEW SCORES WITH AN E. SINCE SEX AND GENDER ADMINISTRATIVE SUPPLEMENT PROGRAMS STARTED IN FY 13, ORWH INVESTED NEARLY $33 MILLION IN THESE INVESTIGATORS FUNDED BY INSTITUTES AND CENTERS, TO CATALYZE NEW EXAMINATIONS AND HOAR ARE RANK ORDER IN TERMS OF WHICH INSTITUTE FUNDING PIs HAVE RECEIVED FUNDING. NIH LEAD THE PACK. IF YOU WANT TO CONSIDER THE NUMBER OF ADMINISTRATIVE SUPPLEMENTS SO THE NUMBER OF PIs WHO HAVE BENEFITED 341 HAVE BEEN SUPPORTED BY ORWH SINCE FY 123, AS YOU KNOW, WE RENEWED THIS PROGRAM IN FY 19. I'M HIGHLIGHTING THREE INVESTIGATORS. DR. (INAUDIBLE) DR. WHITE AND DR. UDEN AND THEIR PARENT GRANTS FROM NCCIH NCI AND NIMHD HERE FOR YOU. IN THE FIRST CASE, SHE'S LOOKING AT MECHANISMS UNDERLYING ANABOLIC EFFECTS OF CYCLIC COMPRESSIVE LOADING AND MUSCLE AND ADDING SUBJECTS TO AN EXISTING STUDY TO INCREASE THE POWER TO DETECT SEX DIFFERENCES. TO TEST FOR SEX DIFFERENCES. DR. WHITE IS LOOKING AT GLIAL BLASTOMA IN A U-54. HE IS DOING BOTH PRE-CLINICAL AND CLINICAL IN HIS SUPPLEMENT, ADDING ANOTHER SEX OR GENDER TO A SINGLE SEX STUDY. DR. UDEN IS LOOKING AT EPIGENOMIC PREDICTORS OF PTSD AND TRAUMATIC STRESS IN AFRICAN AMERICAN COHORT IN VERY INTERESTING STUDY, SHE'S DOING COMPARATIVE ANALYSIS OF EXISTING DATA SET. SO THOSE ARE THREE DIFFERENT STRATEGIES THAT INVESTIGATORS ARE USING AND THAT ARE PROVIDED FOR IN THE SEX AND GENDER ADMINISTRATIVE SUPPLEMENT PROGRAM. OUR NEWEST IS SUPPLEMENT PROGRAM U 3 ADMINISTRATIVE SUPPLEMENT PROGRAM TO DATE SUPPORTED 23, AT $4.4 MILLION AND WE REISSUED THE FOA THIS YEAR AS YOU KNOW. I'M FEATURING FOR YOU HERE DR.S SARA BROWN AND CONNIE BENSON AT UCSD AND THEY ARE TESTING A NOVEL WIRELESS INGESTIBLE SENSOR SYSTEM FOR MEASURING MEDICATION ADHERENCE IN HIV TREATMENT AND PREVENTION. THIS STUDY WILL PROVIDE PK DATA FOR AMERICAN WOMEN FOR THE FIRST TIME. AND INVESTIGATE PATTERNS OF ADHERENCE TO PREP USE AMONG DISADVANTAGED U.S. WOMEN. IT'S THIS PARTICULAR DETECTION DEVICE ALLOWING THEM TO MONITOR ADHERENCE IN A VERY CREATIVE WAY. I'M LOOKING FORWARD TO HEARING ABOUT THIS STUDY TOO. ONE OF THE QUESTIONS Y'ALL ASKED PREVIOUSLY WAS RELATED TO SEX AND GENDER PEER REVIEW. I'M PLEASED TO SHARE WITH YOU SABB EXPERTISE AND SEX AND GENDER ANALYSIS IS BEING -- HAS BEEN ADDED, EXCUSE ME, TO THE ODP DATABASE. THE OFFICE OF DISEASE PREVENTION CREATED A SURVEY THAT LEADS TO A DATABASE TO REVIEW EXPERTISE OF POTENTIAL PEER REVIEWERS. THERE ARE FEWER REVIEWERS WITH PREVENTION RESEARCH EXPERTISE, SO THAT WAS THEIR MOTIVATION BUT THEIR COLLABORATED WITH US TO ADD FIELD ON SEX AND GENDER ANALYSIS, AS WELL AS CONTENT TOPIC AREA OF EXPERTISE FOR SABB TO THEIR SURVEY. SO YOU CAN HELP US BY GETTING THE WORD OUT THROUGH YOUR NETWORKS TO INVESTIGATORS WHO ARE ACCOMPLISHED IN THESE TWO AREAS TO ENCOURAGE THEM TO SEND THEIR INFORMATION THROUGH THIS SURVEY, WHICH MEANS THEY COULD BE CONSIDERED TO SERVE ON PEER REVIEW PANELS AND REPRESENT THESE AREAS. THAT IS AN ISSUE Y'ALL HAVE BROUGHT TO OUR ATTENTION IN PREVIOUS MEETINGS SO I WANT TO UPDATE ON ONE STRATEGY ORWH HAS UNDERTAKEN TO ADDRESS THAT. WOMEN IN BIOMEDICAL CAREERS REMAINS ONE OF OUR KEY MISSION AREAS. I WAS PRIVILEGED TO PARTICIPATE IN THE LANSETT WOMEN EFFORT IN NEW YORK CITY WITH THE LAUNCH OF THE HISTORIC LANSETT ISSUE CHAMPIONING ADVANCING WOMEN IN SCIENCE. THEY TOOK ON THIS ISSUE FROM A VARIETY OF VANTAGE POINTS FROM FROM BIBLIOMETRIC ANALYSIS TO SEX RELATED REPORTING TO THE BUSINESS CASE FOR DIVERSITY INCLUSION, AND TO ACHIEVING WOMEN EQUITY IN ACADEMIC MEDICINE, THEY TOOK THIS ISSUE ON FROM VERY MANY VANTAGE POINTS. I WANT TO HIGHLIGHT THEY PUBLISHED A PIECE ON THE EFFECTIVENESS OF THE ADVANCE PROGRAMS, PROGRAMS THAT HAVE BEEN AROUND FOR SOME TIME AND ARE VERY HELPFUL AND WE HOPE TO HAVE THOSE INFORM NIH NEXT STEPS. FROM AMONG OTHERS. MY PARTNER HERE, DR. JUDY REAGAN CENTER I WANT TO CONGRATULATE HER LEADING THIS EFFORT FOR THIS PUBLICATION, MY PLEASURE TO WORK WITH HER ON, INTEGRATING SEX AND GENDER CONSIDERINGS IN RESEARCH AND EDUCATING THE SCIENTIFIC WORK FORCE. THESE TWO SENTENCES REALLY HIGHLIGHT THE IMPORTANCE OF ORIENTING PEOPLE TO SEX AND GENDER THROUGHOUT ALL THE HEALTH PROFESSIONS. SO THOUGH MUCH WORK REMAINS TO BE DONE, WE DO HAVE THE FOUNDATIONS LAID FOR CHANGING HOW SEX AND GENDER CONSIDERATIONS ARE ADDRESSED IN RESEARCH. BUT THE STATION ARE VERY HIGH FOR US TO REALLY ACHIEVE FULL BENEFIT OF THOSE INVESTMENTS. WE THINK THAT IS OPTIMAL HEALTH FOR VIRTUALLY ALL PEOPLE ACROSS THE LIFE SPAN, REGARDING OF SEX OR GENDER. FROM AT BURCH MEETING THIS YEAR WE HAD SCHOLARS PIs AND OTHER INTERESTED PARTIES BROUGHT TOGETHER FOR OPPORTUNITIES TO PRESENT AND NETWORK AND LEARN MORE AND TO ASK QUESTIONS AND TO HEAR FROM JON RUTH KIRSCHSTEIN MEMORIAL LECTURER HERE LAST YEAR. THE TITLE OF HER PRESENTATION WAS MENTORING AS MEDICINE. IT WAS VERY UNIQUE. I ENCOURAGE YOU THE LOOK AT THE VIDEOCAST AND SHARE WITH OTHERS. WE CONTINUE TO PROMOTE SORRY ABOUT THAT. WE CONTINUE TO PROMOTE WOMEN SCIENTISTS AND CAREER ENHANCING NETWORKING IN A VARIETY OF WAYS. ONE OF THE WAYS WE ARE DOING THAT IS BY SYSTEMATICALLY PUTTING FORWARD WOMEN IN VARIOUS PATHWAYS. ONE IS A WEDNESDAY AFTERNOON LECTURE SERIES WHICH IS ONE OF THE MOST PRESTIGIOUS NIH LECTURE SERIES AND WE WERE PLEASED TO HAVE DR. NELSON RECENTLY, SHE'S PRESIDENT OF THE SOCIAL SCIENCE RESEARCH COUNCIL AND PROFESSOR OF SOCIOLOGY COLUMBIA UNIVERSITY. SHE SPOKE ON THE SOCIAL LIFE OF DNA LOOKING AT THE INTERSECTIONS OF ISSUES RELATED TO RACE, SEX, SCIENCE HISTORY AND SOCIAL ISSUES. SHE SPOKE TO THE WORKING GROUP OF WOMEN IN BIOMEDICAL CAREERS, WOMEN OF COLOR COMMITTEE, PRIOR TO HER PRESENTATION AND TALKED ABOUT HER PATH AND STORY. AND SHE'S FEATURED IN THE NOWS LETTER, QUARTERLY PUBLICATION THAT YOU WILL BE RECEIVING OR HAVE RECEIVED ALREADY. TO OTHER RECENT -- TWO OTHER SPEAKERS DR. JULIE AND DR. LAUREN ARE HIGHLIGHTING ISSUES RELATED TO THE MICROBIOME AND THOSE ARE FEATURED HERE FOR YOU AS WELL. SO THERE HAVE BEEN TEN HIGH PROFILE WOMEN SPEAKERS SINCE LAST FALL IN THE WALS LECTURE, SO RAISING VISIBILITY IS SOMETHING THAT WE KNOW IS VERY IMPORTANT AND GETTING WOMEN RECOGNITION FOR THEIR ACCOMPLISHMENTS IN SCIENCE IS ALSO SOMETHING THAT'S IMPORTANT TO US. I THINK YOU ARE ALSO MANY OF YOU AWARE THAT THE NATIONAL ACADEMIES OF SCIENCE AND ENGINEERING AND MEDICINE HAS TAKEN ON REVISITING A SEMINOLE REPORT THAT'S OVER TEN YEARS, THAT WAS OUT OVER TEN YEARS AGO, 2007, CALLED BEYOND BIAS AND BARRIERS, FULFILLING THE POTENTIAL OF WOMEN IN ACADEMIC SCIENCE AND ENGINEERING. ADS I LOOK AT THAT TITLE I HAVE TO SAY WE HAVE NOT FULFILLED POTENTIAL OF WOMEN IN ACADEMIC SCIENCE AND ENGINEERING. IT'S BEEN OVER TEN YEARS. SINCE THIS REPORT WAS OUT. CAREER IMPEDIMENTS FOR WOMEN, DEPRIVE THE NATION OF IMPORTANT SOURCE OF TALENT, TALENTED AND ACCOMPLISHED SCIENTISTS AND ENGINEERS WHO CONTRIBUTE TO OUR NATION'S COMPETITIVENESS. PEOPLE ASK ME CAN YOU GIVE AN ESTIMATE WHAT WE ARE MISSING OUT ON? THE ANSWER IS WE CAN'T EVEN KNOW WHAT WE ARE MISSING OUT ON BECAUSE PEOPLE HAVE LEFT SCIENCE, PEOPLE HAVE CHOSEN NOT TO ENTER SCIENCE. AND PEOPLE HAVE NOT REACHED FULL POTENTIAL, LET'S BE HONEST ABOUT THAT. SO WE HAVE WORK TO DO IN THAT SPACE AS YOU KNOW, BACK THEN. NIH TOOK THAT REPORT VERY SERIOUSLY, ESTABLISHED A WORKING GROUP OF WOMEN IN BIOMEDICAL CAREERS, THEN CO-CHAIRED BY THE THEN NIH DIRECTOR ELIAS ZERHOUNI AND DR. VIVIAN PENN PRIVILEGED TO CO-CHAIR WITH DR. COLLINS. I'M GOING TO TOUCH ON THIS, FUTURE WE'LL HAVE MORE TIME TO TALK ABOUT THESE CAREER EFFORTS, WE ADDRESS THIS FROM A VARIETY OF PERSPECTIVES BUT DR. ZERHOUNI HUENY CHARGED US TO DEVELOP TANGIBLE STRATEGIES AND INNOVATIVE APPROACHES TO ADDRESS THOSE ISSUES. FAMILY FRIENDLY POLICIES AND PROGRAMS ARE HIGHLIGHTED HERE FROM ESTABLISHING A BANK SO NIH FOLKS SHARE THEIR BEING ABLE TO ESTABLISH OR BRING TEMPORARY LAB MANAGER IF SOMEBODY PI OR POST DOC NEEDS TO GO DOWN TO PART TIME, THOSE ARE SOME OF THE THINGS THAT WE PUT IN PLACE BUT OF COURSE ONE OF THE MOST IMPORTANT WAS TO FUND RESEARCH ON THESE ISSUES. HOW WHAT ARE THE FACTORS THAT EFFECT WOMEN, WHAT ARE THE BARRIERS FOR WOMEN, AND WHAT ARE THE INTERVENTIONS THAT ARE EFFECTIVE. SO WE COLLABORATION 11 INSTITUTES AND FOUR OFFICES, TO THE TUNE OF $16.8 MILLION SUPPORTED 14 GRANTS TO ADDRESS THESE ISSUES AND GENERATE EVIDENCE THAT RESEARCH ADDRESS ISSUES SUCH AS UNCONSCIOUS BIAS MENTORING INSTITUTIONAL FLEXIBILITY, UPTAKE OF FAMILY FRIENDLY POLICIES OR THE LACK THEREOF. THESE INVESTIGATOR FORMED THEIR OWN RESEARCH PARTNERSHIP. IT'S A GRASSROOTS GROUP THAT CONTINUES TO WORK TOGETHER. THEY PUT OUT OVER 120 PUBLICATIONS INCLUDING THE ONES FEATURED HERE, THE ONE ON THE LEFT HIGHLIGHTS ORWH AND NIH EFFORTS TO CATALOG THE WAYS THAT WE HAVE ADDRESSED ALL THE RECOMMENDATIONS FROM BEYOND BIAS AND BARRIERS, THERE IS WORK THAT REMAINS TO BE DONE TO REALIZE THE CHANGE THAT WE SEEK. FAST FORWARD TODAY, THE NATIONAL ACADEMIES IS ADDRESSING UNDERREPRESENTATION OF WOMEN IN STEM THROUGH A STUDY THAT WE ARE PLEASED TO SUPPORT. IN COLLABORATION WITH THE NATIONAL SCIENCE FOUNDATION. AND L'OREAL USA. WHAT IS THAT STUDY GOING TO DO? EXAMINE HOW WOMEN PARTICIPATION VARIES ACROSS DISCIPLINES, BECAUSE WE KNOW COMPUTER SCIENCE IS VERY DIFFERENT FROM BIOMEDICAL ENGINEERING. IT'S GOING TO LOOK HOW THE INTERSECTION OF RACE AND GENDER EFFECTS WOMEN OF COLOR WHO HAVE A VERY DIFFERENT EXPERIENCE THAN WOMEN NOT OF COLOR, WHAT INTERVENTIONS PRODUCED SUSTAIN IMPROVEMENTS IN REPRESENTATION AND LEADERSHIP. NOT SOMETHING THAT YOU PUT THE PROGRAM IN, THE PERSON LEADING IT LEAVES THE UNIVERSITY, THE PROGRAM GOES AWAY, AND THE BENEFITS GO AWAY, WE ARE LOOKING FOR SUSTAINED ADVANCEMENT AND WHY EFFECTIVE INTERVENTIONS HAVE NOT BEEN SCALED UP OR ADOPTED% MORE SYSTEMATICALLY AND SYSTEMIC ALLY. THIS GROUP IS CHARGED, THIS IS RUN OUT OF THE COMMITTEE ON WOMEN AND SCIENCE ENGINEERING MEDICINE. TO -- CHARGED WITH DEVELOPING ACTIONABLE RECOMMENDATIONS TO IMPROVE REPRESENTATION LEADERSHIP BEING CHAIRED BY DR. MAY JEMISON. WE ARE SO EXCITED ABOUT THIS AND YOU WILL HEAR LATER IN THE PROGRAM SOME EXCERPTS FROM THE MARCH MEETING ON THE FIRST WORKSHOP MEETING THEY HAVE HAD FOR THE STUDY. A FEW OTHER THINGS TO HIGHLIGHT ACROSS NIH IN THE CAREER SPACE, THE BRAIN INITIATIVE DEVELOPED A PROGRAM TO PROMOTE DIVERSITY, WITH A FOCUSED ATTENTION ON LAUNCHING CAREERS FOR WOMEN AND WE WERE PLEASED TO SUPPORT THAT ALONG WITH OTHERS. IT'S A K-99 R-00 DEDICATED TO AREAS ADDRESSED BY THE BRAIN INITIATIVE, PROVIDES AN EXTRA YEAR IN THERE AND IS DESIGNED TO HELP AWARDEES FROM DIVERSE BACKGROUNDS LAUNCHED INDEPENDENT RESEARCH DAKERS RADIO. CAREERS. I SAW DR. VALANTINE JOIN US AND WE ARE LOOKING FORWARD TO HER COMMENTS AND YOU WILL HEAR FROM HER IN A FEW MINUTES. BUT I WANT TO PAUSE TO HIGHLIGHT THIS ISSUE THAT IS OF TRUE IMPORTANCE TO BOTH WOMEN AND MEN IN THE FUTURE OF SCIENCE. SEXUAL HARASSMENT, PER DR. COLLINS IS ABOUT POWER, IT'S REPREHENCABLE, AND IT'S A MAJOR OBSTACLE KEEPING WOMEN FROM ACHIEVING THEIR RIGHTFUL PLACE IN SCIENCE. YOU WILL HEAR ABOUT THE EXTENSIVE STEPS NIH IS TAKING BEYOND UNDERSTANDING PROBLEM AND DOING SOMETHING ABOUT IT. BUILDING CONNECTIONS IS MY LAST SECTION, I WANT TO CONGRATULATE MY ORWH COLLEAGUES AND ALL THEIR PUBLICATIONS. A FEW HIGHLIGHTED HERE. THEY RANGE FROM TOPICS RELATED TO POLYCYSTIC OVARY SYNDROME FROM ONE OF OUR SCIENCE POLICY FELLOWS, DR. HOPKINS WHO HAS JOINED US TO CONCEPTUAL FRAMEWORKS AROUND CARE GIVING, ONE OF OUR ASSOCIATE DIRECTORS. SO JUST TO HIGHLIGHT THE AMAZING WORK BEING DONE IN TERMS OF SCIENTIFIC SCHOLARSHIP. AND AREAS THAT TEAM ORWH WORKS IN. THEY TRULY ARE AMAZING GROUP OF FOLKS AND I WANT TO SHARE THAT WITH YOU. WE ALSO HAD THE OPPORTUNITY AS DID OTHER ENTITIES AT NIH TO TAKE OVER THE MAIN NIH SOCIAL MEDIA ACCOUNTS IN JANUARY, IT WAS CALLED SOCIAL MEDIA TAKE OVER. WE DID GREAT. HERE ARE SOME OF THE INFORMATION WITH OUR 76 POSTS, WE HAD OVER 1700 COLLISION, ALMOST 3,000 ENGAGEMENTS. NEARLY 31 MILLION POTENTIAL VIEWERS. HERE IS A LITTLE BIT MORE OF A BREAK DOWN. WE PLACED FIFTH AMONG THESE 19 ICOs PARTICIPATING. WITH AS I HIGHLIGHTED FOR YOU THE DATA THERE. FOUR OF OUR POSTS WERE IN THE TOP 50, A BIG DEAL FOR A LITTLE OFFICE. SO I WANT TO COMMEND MR. WILLIAMS AND COMMUNICATIONS TEAM FOR LEADING THIS EFFORT IN THE FIRST -- ALMOST FIRST WEEK OF A NEW YEAR, VERY BUSY TIME, LOTS OF PEOPLE PARTICIPATED TO GET US IN THAT SPACE. WE HAVE BEEN WORKING VERY HARD TO GET THE WORD OUT ADS BROADLY AS POSSIBLE ABOUT THE ISSUES OF IMPORTANCE TO US, AND WOMEN GETTING OVERLOOKED IN HEALTHCARE KEEPS COMING UP OVER AND OVER. I'M NOT PUSHING THAT OUT PEOPLE ARE ASKING ME QUESTIONS ABOUT IT OVER AND OVER. SO IT WAS MY PLEASURE TO BE IN THIS PODCAST WITH SERENA WILLIAMS AND DR. CHU WHERE MS. WILLIAMS SPOKE ABOUT HER PREGNANCY EXPERIENCE AND USING HER PLATFORM TO BRING AWARENESS TO THE ISSUE THAT IT REALLY DOESN'T EVEN MATTER IF YOU'RE A CELEBRITY OR TOP ATHLETE FOR BLACK WOMEN, THEIR EXPERIENCE IN GIVING BIRTH IS DIFFERENT AND THERE'S SOMETHING WE NEED TO DO ABOUT THAT. SO WE HAVE HEIGHTENED OUR VISIBILITY IN MEDIA AND OTHERWISE. WE PARTICIPATED IN COMMONWEALTH FUND INTERVIEW ADDRESSING THE SAME MEDICAL RESEARCH GAP, AND NBC TODAY SHOW INTERVIEW SUPPOSED TO BE AIRED TOMORROW AS PART OF BLACK MATERNAL HEALTH WEEK AND ONLINE TODAY.COM AS WELL ON SUBOPTIMAL TREATMENT OF WOMEN. JUST TO FLAG A FEW THINGS FOR YOU, DR. CHOLINE ADVISORY COMMITTEE MEMBERS IS CURRENT PRESIDENT OF THE ORGANIZATION FOR THIS STUDY OF SEX DIFFERENCES AND THEY ARE HAVING THEIR ANNUAL MEETING COMING UP VERY SOON. WE ARE PRIVILEGED TO PARTICIPATE BY POSTING A SYMPOSIUM THERE. LEADERSHIP TEAM WILL BE PRESENTING. VIVIAN PENN SYMPOSIUM AS I HIGHLIGHTED A FEW MOMENTS AGO, MAY 15, HAVE IT ON OUR CALENDARS AND SHARE THE WORD, WE WILL BE VIDEOCASTING THAT LIVE AND ADDRESSING MATERNAL HEALTH. THE LATEST ISSUE OF WOMEN HEALTH AND FOCUS NEW QUARTERLY PUBLICATION IS AVAILABLE TO YOU. WE HAVE SEEN 15% YEAR-OVER-YEAR INCREASE IN THE NUMBER OF SUBSCRIBERS THAT'S ASSOCIATED WITH A 30% YEAR-OVER-YEAR INCREASE IN WEBSITE TRAFFIC. KUDOS TO ASSOCIATE DIRECTORS WHO HAVE ALL HAD COLUMNS IN THIS QUARTERLY PUBLICATION, MR. WILLIAMS AND ENTIRE COMMUNICATIONS TEAM BECKY ABLE AND OTHERS WHO MADE SURE THESE PUBLICATIONS ARE HIGH QUALITY AND WE ARE HIGHLIGHTING IN THESE PUBLICATIONS WORK CONDUCT AND SUPPORTED BY THE INSTITUTES AND CENTERS SO THIS TRULY REPRESENTS ALL NIH EFFORTS AROUND NIH RESEARCH AND WE FEEL OUR ROLE IS TO PUT THAT IN FOCUS FOR YOU AND OTHERS. SO OUR INFORMATION IS HERE AND THIS IS NOW MY NEW FAVORITE I CALL THIS A LANDING SLIDE. THIS IS MY NEW FAVORITE LANDING SLIDE AND IT SAYS IT ALL, A WELL TRAINED DIVERSE ROBUST WORK FORCE IS ENGINE OF SCIENTIFIC PROGRESS. WITHOUT THAT WE REALLY CAN'T GET TO WHERE WE WANT TO BE. WE TALKED ABOUT MAP AT THE BEGINNING OF STRATEGIC PLAN AND THIS IS HOW WE GET TO WHERE WE WANT TO BE. THANK YOU VERY MUCH FOR YOUR ATTENTION. IT'S MY PLEASURE TO SHIFT GEARS A LITTLE BIT. TO OUR NEXT PRESENTATION WHICH IS FROM DR. HANNAH VALANTINE, WE ALSO WANT TO HEAR FROM JESSICA HAWKINS WHO JOINED US AS WELL. DR. VALANTINE IS THE FIRST NIH CHIEF OFFICER FOR SCIENTIFIC WORK FORCE DIVERSITY. ADS SENIOR INVESTIGATOR IN THE INTRAMURAL INVESTIGATOR AT NHLBI LEADING NIH EFFORTS TO PROMOTE DIVERSITY THROUGH INNOVATION ACROSS THE NIH FUNDED BIOMEDICAL WORK FORCE THROUGH A RANGE OF EVIDENCE BASED APPROACHES, I'M GOING TO GO AHEAD AND INTRODUCE MS. HAWKINS ADS WELL, SHE WILL TAG TEAM, DR. VALUE TIME, MS. -- VALANTINE, SHE OVERSEES THE EXPANDING ROLES AN RESPONSIBILITIES, I DON'T KNOW IF FTE EXPANDED BUT RESPONSIBILITIES DEFINITELY EXPANDED. SHE IS CONTINUING IN THAT PROGRAM TO PREVENT AND RESPOND TO REAL AND PERCEIVED CONCERNS OF ALLEGATIONS OF HARASSMENT AND WORKPLACE VIOLENCE, ACROSS ALL THE 27 INSTITUTES AND CENTERS. SO THAT EXPANSION INCLUDES CENTRALIZED OVERSIGHT SO SHE WILL TELL US MORE ABOUT THAT. 24 YEARS OF FEDERAL SERVICE AND SO I'M LOOKING FORWARD TO HEARING FROM HER AS WELL. WITHOUT FURTHER ADIEU, DR. VALANTINE, SOMEBODY WILL COME PUT YOUR SLIDES UP FOR YOU. >> THANK YOU SO MUCH. THANK YOU FOR THAT LOVELY INTRODUCTION. [APPLAUSE] >> I MUST SAY IT'S A PLEASURE TO WALK INTO THIS ROOM, I JUST WALK IN AND I SEE REALLY FRIENDLY FACES PEOPLE I HAVE KNOWN FOR A LONG TIME WHO ARE BEING DRIVING THIS WORK TO GET WOMEN'S VOICES HEARD IN TERMS OF WORK FORCE AS WELL AS WOMEN INCLUDED IN RESEARCH, REALLY PUSH THE FIELD TREMENDOUSLY SO I'M PARTICULARLY DELIGHTED TO BE HERE SO JANINE, THANK YOU FOR THE OPPORTUNITY TO PREVENT JUST IN A VERY SMALL SECTION OF THE WORK THAT MY OFFICE HAS BEEN DOING WHICH WAS AROUND THIS AREA OF SEXUAL HARASSMENT. AND TO BEGIN WITH WHAT I THINK I WOULD LIKE TO JUST PUT THIS INTO CONTEXT WHAT WE TALK ABOUT HERE IS TO GIVE YOU SOME BACKGROUND ABOUT THE HOW WE HAVE BEEN INFORMED BY THE NATIONAL ACADEMY IES REPORT ON SEXUAL HARASSMENT AND HOW IT INFORMS NIH NEWER ACTIONS I WILL TALK QUITE A BIT HOW WE MEASURE WORKPLACE CLIMATE IN THOSE CULTURES. THAT ARE REALLY THE HARBINGERS OF WHAT WE ARE SEEING THAT IS DRIVING WOMEN OUT OF SCIENCE AND MY COLLEAGUE JESSICA HAWKINS WILL TALK MORE ABOUT WHAT WE ARE DOING INTERNALLY FOR NIH WORK PERCENT WHICH SERVE AS MODELS FOR WHAT OUR OTHER INSTITUTIONS OUT THERE CAN AND SHOULD BE DOING. SO THE NATIONAL ACADEMIES REPORT IS ALLUDED TO IS REALLY A LAND MARK DOCUMENT BECAUSE FOR THE VERY FIRST TIME IT MADE THIS VERY STRONG CASE THAT SEXUAL HARASSMENT IS A MAJOR IMPEDIMENT TO WOMEN'S ADVANCES. THE WAY IT REALLY BEAUTIFULLY ARTICULATED IS IT EXPANDED THIS WHOLE OF THINKING OF WHAT SEXUAL HARASSMENT IS. THEY CLEARLY ARTICULATED SEXUAL HARASSMENT TO BE INVOLVED IN THREE DISTINCTIVE TYPES OF BEHAVIORS AS DEMONSTRATED HERE. YOU HAVE SEXUAL COERCION, WE HAVE UNWANTED SEXUAL ATTENTION AND SEXUAL ASSAULT, THOSE ARE THE KINDS OF THINGS MANY PEOPLE HAVE FOCUSED UPON, UNTIL NOW. INCLUDED IN THAT DEFINITION WAS THIS ISSUE OF GENDER HARASSMENT WHICH IS THE HARBINGER OF ALL OF THESE OTHER KINDS OF BEHAVIORS, THEREFORE EMPHASIZING BEHAVIORAL ASPECT OF ALL OF THIS. THE SEXUAL HARASSING BEHAVIORS THEY POINTED OUT CAN BE EITHER TARGETED TO THE INDIVIDUAL OR ACTUALLY AMBIENT, WITHIN THAT CULTURE THAT IS SUPPORTED OF THIS KIND OF BEHAVIOR. IN PARTICULAR THEY MAKE THE STRONG POINT GENDER HARASSMENT IS NOT UNCOMMON, IT'S A PUT DOWN, THIS IS THAT KIND OF PUT DOWN AND THOSE VERBAL AND NON-VERBAL COMMUNICATIONS THAT OCCUR THAT KEEP WOMEN AT THE PERIPHERAL OF SCIENCE. THEY REFER TO IT AS DEATH BY A THOUSAND CUTS. THIS FORM OF GENDER HARASSMENT I'M SURE MANY OF US IN THE ROOM EXPERIENCE, ACTUALLY AS SIGNIFICANT, AND THERE'S TREMENDOUS RESEARCH I DON'T HAVE TIME TO GO THROUGH, THEY ARE AS SIGNIFICANT IN THEIR EFFECT ON WOMEN'S HEALTH WOMEN ADVANCEMENT AS THESE OTHER FORMS OF SEXUAL HARASSMENT WE GENERALLY THINK ABOUT. SO VERY IMPORTANT STUDY. WHICH PUSHES US TO THINK ABOUT WHAT ARE THE CULTURES AND HOW CAN WE CHANGE CULTURE TOWARDS (INAUDIBLE) HERE IS SUGGESTING DATA TO EMPHASIZE THIS HIGH LEVEL HIGHER FREQUENCY OF GENDER HARASSMENT COMPARED TO THE OTHER FORMS OF HARASSMENT AND THE FACT THAT INSUFFICIENT ATTENTION TO CLIMATE OF SCIENCE TO THAT CULTURE OF SCIENCE, IT WAS ACTUALLY DESIGNED SEVERAL YEARS AGO WITH ONE PARTICULAR IDENTITY AND HAS NOT CHANGED THAT'S MAJOR HARBINGER OF THIS. HERE IS ANOTHER SET OF DATA JUST TO EMPHASIZE THE POINT I HAVE ALREADY MADE, EMPHASIZING THE FREQUENCY OF GENDER HARASSMENT AND DIFFERENT GROUPS ON GRADUATE STUDENTS, GRADUATE STUDENTS, COLLEGE STUDENTS AND MEDICINE AND IN EACH OF THESE YOU SEE THOSE EXPERIENCES OF GENDER HARASSMENT, THOSE WORDS, THOSE EXCLUSIONARY BEHAVIORS IS MUCH HIGHER THAN ANY OTHER FORM. OF HARASSMENT. WE KNOW THAT ADDITIONAL WORK THAT WAS DONE IN THAT REPORT WAS DEMONSTRATE THE IMPACT THESE EXPERIENCES HAD ON WOMEN, THEY ARE LISTED HERE, IMPORTANTLY, ALLUDING TO WHAT JANINE WAS TALKING ABOUT, THIS IS WHERE WE ARE LOSING, WHEN THEY EXPERIENCE THESE -- HOW THESE EX-- HAVE THESE EXPERIENCES. THEY STEP DOWN FROM LEADERSHIP POSITIONS, THEY LEAVE THE INSTITUTION, AND I WILL BE THE FIRST TO ADMIT THAT IN MY 12 YEARS OF THINKING ABOUT CAUSAL FACTORS MOST OF US HAVE THE PRESENTATIONS THAT WE HAVE. ON THIS CAUSAL FACTOR OF WHY WOMEN ARE LEAVING SCIENCE AND MEDICINE. WE GIVE A LITTLE BIT ATTENTION TO SEXUAL HARASSMENT REALLY NOT EMPHASIZING IT AND THIS HAS TURNED OUT TO BE VERY IMPORTANT. IN ADDITION THE REPORT POINTED OUT CERTAIN AREAS, CERTAIN CULTURES, THAT PERPETRATE THESE KINDS OF BEHAVIORS, SPACES THAT ARE RIFE WITH ISOLATION SUCH AS LABS, PATIENT GROUPS, FIELD SCIENCE, ET CETERA. AND THE IMPACT IS THIS DEPRESSION, LOSS OF AUTONOMY, SHAME, GUILT AND DEPRESSION. WHY AM I TELLING YOU THAT? BECAUSE IT IS THE BASIS ON WHICH WE DESIGN A CLIMATE SURVEY. I WILL SHOW YOU HOW THAT MOVES ON. WE WANT NOT ONLY THE PREVALENCE OF EXPERIENCE BUT WE WANT TO LOOK AT ASSOCIATIONS AND MOVE TO CAUSE TO INTERVENE APPROPRIATELY. IMPORTANTLY, ASIDE FROM THIS DEVASTATING IMPACT OF THIS PICTURE I PAINTED ON WOMEN PARTICULARLY, SOMETIMES MEN THIS HAS PARTICULAR IMPACT ON THE SCIENTIFIC ENTERPRISE ITSELF. INASMUCH AS THIS IS DEVASTATING FOR WOMEN, IT IS BAD FOR SCIENCE. SO HERE ARE THE NIS RECOMMENDATIONS, I'M SURE THE MAJORITY OF PEOPLE IN THIS ROOM HAVE RED THIS REPORT, IF YOU HAVEN'T I URGE YOU TO DO THAT. THEY URGE US TO THINK ABOUT THE FIRST ONE ADDRESSING GENDER HARASSMENT. THAT FEEDS RIGHT BACK TO THE CULTURE AND THESE ARE THINGS WE ARE DOING HERE INCLUDING THE FACT THAT DR. COLLINS SET UP A SPECIFIC WORKING GROUP TO COME UP WITH SPECIFIC RECOMMENDATIONS. HOW WE CAN CHANGE THE CULTURE TO END HARASSMENT. IN A WAY WE NEED TO MOVE BEYOND THE LEAGUE OF COMPLIANCE ISSUES WHICH ARE VERY IMPORTANT BUT TO ACTUALLY ADDRESS THE CULTURE. THERE ARE MANY RECOMMENDATIONS BUT IMPORTANTLY HERE, WE NEED TO MEASURE PROGRESS. SOMEHOW OR OTHER THE RESPONSIBILITY FOR MEASURING PROGRESS TO MY OFFICE, I'M STILL TRYING TO FIGURE OUT WHY NOT BEING A BEHAVIORAL SCIENTIST MYSELF, I GOT TREMENDOUS HELP FROM THE COMMUNITY, TO -- FOR US TO DESIGN A WORKPLACE CLIMATE SURVEY. WITH INPUT FROM EXPERTS IN THE FIELD OF SEXUAL HARASSMENT. SO HERE ARE OUR SURVEY GOALS. WE WANTED TO ASSESS THE WORKPLACE CLIMATE OF COURSE. TO IDENTIFY THE POTENTIAL ELEMENTS AND THE NIH ORGANIZATIONAL CLIMATE, ASSOCIATED WITH SEXUAL HARASS MENT. WITH DEVELOPING INTERVENTIONS, TO DETERMINE THE IMPACT ON CAREER CHOICES. WE KNOW ANECDOTALLY A LOT OF STUDIES THAT I HAVE ALREADY MENTIONED WOMEN ARE MOVING, LEAVING BECAUSE OF THESE EXPERIENCES. BUT WHAT CAN WE LEARN THAT WILL HELP US TOWARDS ACTION. AND TO MEASURE THESE IMPORTANT OUTCOMES AS I MENTIONED. SO WE LAUNCHED THIS SURVEY AND DESIGNED IT SPECIFICALLY TO ADDRESS ALL OF OUR NIH INTERNAL WORK FORCE. THIS IS REALLY IMPORTANT BECAUSE IT MAKES THE CASE THAT EVERYBODY CONTRIBUTES TO THIS CULTURE. IN MANY OF THE SURVEYS THAT WE DO INTERNALLY FOR NIH, WE JUST DELIVERED TO THE FEDERAL EMPLOYEES BUT AT THIS TIME WE WANTED TO KNOW HOW THE STUDENTS WERE FEELING TRAINEES THE PEOPLE HERE DOING FANTASTIC WORK AS CONTRACT AND EVERYBODY ELSE AND VERY IMPORTANTLY, WE DESIGNED BECAUSE IT WAS ANONYMOUS PRIVATE AND CONFIDENTIAL. SO I WILL SAY THERE GIVEN WHAT WE HAVE EXPERIENCED BEFORE AND KNOWING THAT LIMITATIONS OF THESE THINGS BEING TOTALLY ANONYMOUS, THERE WAS SOME DEGREE OF SKEPTICISM HOW WE WOULD GOING TO KEEP THIS ANONYMOUS. HERE IS THE FRAMEWORK OF THE DESIGN OF THIS -- AT THE CORE WE HAVE SEXUAL HARASSMENT. WE KNOW FROM THE LITERATURE THERE ARE MANY FACTORS THAT FEED INTO IT. FOR EXAMPLE, ORGANIZATIONAL CLIMATE WHICH IS A KEY ONE I HAVE BEEN TALKING ABOUT THE JOB GENDER CONTEXT, HOW MANY WOMEN ARE WITHIN THE FIELD THAT YOU ARE WORKING IN, A WOMAN LEADER. AND THAT IS WHAT IS CRITICALLY IMPORTANT. I URGE Y'ALL TO WATCH DR. COLLINS' PBS REPORT ON REALLY PUTS AN EXCLAMATION MARK ON THE NEED FOR MORE WOMEN IN LEADERSHIP AS A KEY DRIVER TO SOME OF IT. THEN THERE ARE OTHER EXPERIENCES THAT MAYBE NON-SEXUAL THAT FEED THIS. OF COURSE OUTCOMES PSYCHOLOGICAL AND HEALTH OUTCOMES. SO WE STRUCTURE QUESTIONS TO PROBE ABOUT PERCEPTION OF EQUITY PERCEIVED SUPPORT TOLERANCE SEXUAL HARASSMENT. AND THE JOB CONTEXT PROPORTION OF MEN, WOMEN WHO ARE IN LEADERSHIP AND THEN THE OBVIOUS JOB OUTCOMES SO IT WAS AN EXTENSIVE SURVEY. THAT WAS LAUNCHED IN THE BEGINNING OF THE END OF JANUARY, AND IS JUST CLOSED, WE DON'T HAVE THE RESULTS BUT I WILL SHOW YOU THE RESPONSE RATES. IN THIS FIELD I DISCOVERED THERE'S A LOT OF PUBLICATIONS, VERY FEW OF THEM HAVE GONE THROUGH RIGOROUS VALIDATION. VERY FEW INSTRUMENTS. WE SET ABOUT BY GETTING INPUT FROM EXPERTS SO WE WOULD VALIDATE THIS STUDY. THIS SURVEY. WHY? WE HOPE IT WOULD BE THE INSTRUMENT THAT OTHER INSTITUTIONS MIGHT USE TO COLLECT DATA ACROSS THE NATION. ONE OF THE VALIDATION PARAMETERS IS COGNITIVE TESTING OF A QUESTIONNAIRE. I LEARNED THIS YOU ALL KNOW THAT CARDIOLOGIST, I'M NOT A BEHAVIORAL SCIENTIST, I HAVE TO GET UP TO SPEED. THIS IS TO DO WITH THE RESPONDENT UNDERSTAND WHAT IS MEANT BY THE QUESTIONS IN THE SURVEY. SO THIS WENT THROUGH RIGOROUS TESTING. THEN OF COURSE THERE CAME THE ISSUE, THESE QUESTIONS HAVE BEEN ASKED IN A PARTICULAR WAY ESPECIALLY THE FEQ QUESTIONS, THERE ARE BETTER WAYS OF ASKING THESE QUESTIONS HOW DOES THIS NEW WAY INCORPORATING INTO THE SURVEY COMPARED WITH OA SO WE VALIDATED THAT THROUGH PARTICULAR DESIGN USING VALIDITY MEASURES. I MENTION THE SURVEY HERE FOR THE NIH INTERNAL WORK FORCE THAT INCLUDES OUR INTRAMURAL RESEARCHERS INCLUDES OUR EXTRAMURAL PROGRAM STAFF AND INCLUDES OUR CONTRACTING STAFF, TRAINEES ESSENTIALLY NEARLY 16,000 RESPONSES. WHICH TANTAMOUNT TO 44% RESPONSE RATE, IF YOU BREAK DOWN THE GROUPS YOU CAN SEE IN THE LRGEST GROUP WHICH IS THE FEDERAL EMPLOYEE GROUP, UP TO 56%. THIS IS NOT PERFECT. I WAS GOING FOR 60% AT LEAST RESPONSE RATE SO WE DIDN'T QUITE MAKE IT THERE. YOU MIGHT ASK THE QUESTION WHY 60%. I HAPPEN TO KNOW STANFORD COMPLETED THEIR WORKPLACE CLIMATE SURVEY AND POSTING A RESPONSE RATE OF 60%. MY COMPETITIVE NATURE THOUGHT WE WOULD HAVE TO HAVE AT LEAST THAT. BUT I WOULD SAY THIS. THIS SURVEY WAS -- THERE WERE INCENTIVES. EVERYBODY GOT A $25 AMAZON GIFT CARD. AT WORKPLACE AND THEN THERE WAS A DRAWING THAT YOU WOULD ENTER A BIGGER PRICE SO I BEARING IN MIND NO SPECIFIC INCENTIVES THIS IS A REALLY GOOD RESPONSE RATE IN WHICH WE WILL BE ABLE TO BUILD FURTHER ACTION. LET ME END MY LAST SLIDE BEFORE TURNING IT TO JESSICA. THIS SURVEY UNDERSTANDING WHAT'S GOING ON IS REALLY JUST A SMALL PART OF THIS OVERALL NIH RESPONSE TO THIS PROBLEM. I WANT TO UNDERSCORE THAT. AND SHOW YOU THE BROADER PICTURE OF WHAT NIH IS DOING. SO VERY QUICKLY IN THIS PROCESS WHICH HAS BEEN GOING ON FOR OVER A YEAR, WE REALIZE THAT WE NEEDED GREATER OVERSIGHT INTO THESE ISSUES. A CENTRAL STEERING COMMITTEE, ANTI-HARASSMENT STEERING COMMITTEE, CHAIRED BY OUR PRINCIPLE DEPUTY DIRECTOR LARRY TAI BACK HAS BEEN PUT IN PLACE, IT HAS INPUT FROM ALL ACROSS THE CAMPUS. IT IS IN THAT VENUE THAT WE ARE ABLE TO DO A LOT OF THINGS, FOR EXAMPLE. GROWING OUT OF THOSE DISCUSSIONS WAS THE DEVELOPMENT OF THE CIVIL PROGRAM, THE CENTRAL PLACE WHERE THINGS ARE REPORTED, REPORTED ANONYMOUSLY, YOU WILL HEAR MORE ABOUT THAT FROM JESSICA HAWKINS, VERY IMPORTANT GIVEN WHAT WE KNOW ABOUT THE UNDERREPORTING AND THE FEAR OF REPORTING. POLICIES, GROWING OUT OF THE WORK TO NEW POLICIES, IN PARTICULAR WE ARE VERY HOPEFUL THIS NEW POLICY ABOUT RELATIONSHIPS HELPFUL. THE NIH REPORT POINT TO THIS HIERARCHICAL RELATIONSHIP THAT IS TYPICAL OF SCIENCE AND THAT WHICH PUTS THE TRAINEE AT RISK FROM THIS HARASSMENT SEXUAL AND OTHER HARASSMENT BY PERSON WHICH THEY'RE REPORTING. NOW THIS POLICY, THIS KIND OF RELATIONSHIP ARIDESES, IT MUST BE REPORTED AND THEN REMEDIATED SO THAT RELATIONSHIP IS TAKEN UP SO IT'S NOT BEHOLDING TO THIS PERSON WHO IS THEIR BOSS. VERY IMPORTANT. IT'S NOT REVOLUTIONARY AT ALL. YOU MIGHT ASK QUESTIONS WHY DIDN'T WE ALREADY HAVE IT AS WE LOOKED ACROSS THE COUNTRY A LOT OF COMPANIES HAVE THIS. VERY IMPORTANTLY IS A SET OF NEW TOOLS PEOPLE CAN REPORT THESE EXPERIENCES. NEW WAY OF ADJUDICATING THESE EXPERIENCES. IN THE PAST THEY HAVE BEEN ADJUDICATED WITHIN INSTITUTES OR EQUIVALENT TO YOUR -- WITHIN DEPARTMENTS AND NOW WE HAVE A FULL ADJUDICATION OUTSIDE OF THE DEPARTMENT WHERE THIS OCCURS. IN FACT SOMETIMES BRINGIG IN OUTSIDE PEOPLE TOLL ADJUDICATE. THEN THERE'S TRAINING, NEW WAYS OF TRAINING AND GETTING PEOPLE AWARE IN A MORE CREATIVE WAY ABOUT USING CASE REPORTS, ET CETERA, IN THE LITERATURE, THERE IS A LOT OF DEBATE ABOUT THE EFFICACY OF TRAINING. I WON'T GO THERE. THE NAS REPORTED TO THAT T. THE PROBLEM REALLY IS IN THE PAST, THE MODE OF TRAININGS USED WAS PROBABLY NOT THAT EFFECTIVE BUT THEY ARE NEW WAYS OF DOING THAT. THEN FINALLY I WOULD PUT UNDER IS THIS REALLY THE SURVEY? THE SURVEY ON WHAT WE FIND THERE WILL LEAD US TO DIRECT ACTION. WE PROMISE THE COMMUNITY THAT BY JUNE WE WILL HAVE A PRELIMINARY REPORT BY SEPTEMBER WE WILL HAVE NEW ACTIONS TO ELIMINATE THIS GENDER HARASSMENT IN PARTICULAR WHICH IS PART OF MOST CULTURES OF SCIENCE, I'M GOING TO STOP THERE AND TURN IT OVER TO JESSICA. [APPLAUSE] >> THANK YOU VERY MUCH, DR. VALANTINE. THANK YOU FOR COVERING THIS, THE ANTI-HARASSMENT STEERING COMMITTEE HAS BEEN WORKING REALLY HARD FOR THE LAST YEAR AND A HALF, IT'S BEEN AN AMAZING LEARNING EXPERIENCE FOR ME, EVEN HAVING BEEN AT THE NIH FOR 19 OF THE 24 YEARS. IT'S BEEN A WONDERFUL EXPERIENCE, IT'S ALSO IMPORTANT TO FOR US TO SEE ME BUT ALSO SHARE WITH YOU HOW MUCH SUPPORT WE HAVE FROM NIH LEADERSHIP. THE DIRECTOR AND THE DEPUTY DIRECTOR. EXTREMELY SUPPORTIVE. THAT'S FANTASTIC. WE HAVE GROWN QUITE A BIT IN TERMS OF STAFF TOO, WE CAN PROBABLY USE MORE BUT WE ARE GETTING THERE. AS DR. VALANTINE MENTION THE CIVIL PROGRAM ABSORBED THIS ANTI-HARASSMENT PROGRAM FOR THE INTERNAL NIH, THIS BEGAN IN DECEMBER 2017, BUT WE OFFICIALLY LAUNCHED OUR WHOLE LARGER COMMUNICATION CAMPAIGN THIS PAST OCTOBER. DR. COLLINS SENT A MESSAGE OUT IN DECEMBER 2017 SAYING ALL ALLEGATIONS OF HARASSMENT ARE NOW HANDLED OUTSIDE THE INSTITUTES AND AT THIS LEVEL, TO ENSURE THERE'S OBJECTIVE THOROUGH LOOK AND EVERY INSTITUTION IS DOING IT THE SAME WAY. SO WERE REALLY BUILDING A PLANE A LITTLE BY BIT AS WE WERE FLYING IT, WE HAVE COME A LONG WAY, AND WE HAVE A EXCELLENT PROCESS I'M EXCITED TO SHARE WITH YOU. THE CIVIL PROGRAM HAS BEEN AREN'T FOR MANY YEARS, HOWEVER WE WERE NOT THAT WELL KNOWN BECAUSE OUR FOCUS WAS LARGELY ON WORKPLACE VIOLENCE PREVENTION. SO IN THE ANTI-HARASSMENT STEERING COMMITTEE WAS LOOKING FOR A PLACE TO GIVE THIS INTERNAL WORK, MADE SENSE TO COME TO THE CIVIL PROGRAM AT THE TIME THERE WERE TWO AND A HALF OF US, AT THE TIME WE WERE VERY EXCITE AND SCARED BUT LIKE I SAID, AMAZING EXPERIENCE, WITH OUR WORK WE WOULD WORK WITH MANAGERS ON HUMAN RESOURCES ISSUES, WE TRY TO BE COGNIZANT AND HAVE A TRAUMA INFORMED APPROACH, DOMESTIC VIOLENCE IMPACTED THE WORKPLACE, INTENTIONALLY VOLATILE BEHAVIOR, ALL THOSE TYPES OF THINGS, IT MADE SENSE TO FOLD IN THE HARASSMENT PROGRAM UNDER THIS AS WELL. SO WHAT WE ARE DOING IN PART OF OUR EDUCATION AS DR. VALANTINE SAID WE RECOGNIZE SOME OF THE TRADITIONAL WAYS TRAINING STAFF HAD NOT REALLY BEEN AS EFFECTIVE AS HE COULD BE. WE'RE TRYING TO DO A VARIETIES OF DIFFERENT THINGS IN ADDITION TO A LOT OF IN PERSON TRAINING AND I'M GOING TO TALK ABOUT OUR PARTNER OFFICES, MULTI-DISCIPLINARY APPROACH WHICH IS VERY HELPFUL WE ARE TRYING TO GET OUT THERE AND DO IN PERSON ALSO HAVE MICROBE TRAININGS ON OUR WEBSITE, REGULAR MANDATORY PREVENTION OF SEXUAL HARASSMENT TRAINING, COVERS ALL FORMS OF HARASSMENT WE ARE TRYING TO DO A NICE LAYERED APPROACH, IT WILL TAKE TIME TO REALLY GET THE CULTURE CHANGE TO REALLY HAPPEN. BUT A LOT OF WORK IS UNDERWAY. SO PART OF WHAT THE CIVIL PROGRAM TOOK ON IS OUR NEW TAG LINE IS RECOGNIZE REPORT AND RESPOND. SO WE WILL TALK ABOUT THAT. SO MOST PEOPLE I THINK AT LEAST IN MY EXPERIENCE IN DOING THIS JOB, THERE'S A LOT OF TIMES THE WORD HARASSMENT NOT USED CORRECTLY, SO SOME PEOPLE REPORT THINGS THAT SOUND MORE LIKE THEY ARE ANOWED, NOT HARASSED. SO I'LL COME BACK TO THAT. WE DON'T WANT TO SHUT ANY OF THAT DOWN EITHER BUT IT'S IMPORTANT TO NOTE THE DEFINITION OF HARASSMENT AND SEXUAL HARASSMENT THAT WE HAVE IN OUR MANUAL CHAPTER WHICH IS OUR POLICY ALL OUR POLICIES AT CONNECTION IT COMES FROM THE EQUAL EMPLOYMENT OPPORTUNITY COMMISSION. WE DIDN'T CREATE IT, THE ANTI-HARASSMENT STEERING COMMITTEE USED DEFINITIONS THAT ARE AVAILABLE, I MENTION THIS BECAUSE SOMETIMES NIH COMMUNITY WHEN WE ARE DOING TRAINING LIKE WHERE DID YOU COME UP WITH THIS? OH THE CIVIL RIGHTS ACT IS A LAW. SO IT'S HELPFUL TO POINT THAT OUT. WITH SEXUAL HARASSMENT AGAIN, IT'S A NARROW DEFINITION IF LOOKING AT THE LEGAL TERM. HAS TO BE BASED ON PROTECTED CLASS, MUCH MORE EASY TO IDENTIFY. HOWEVER, WHEN WE ARE LOOKING AT THINGS, WHEN WE ARE DOING OUR INTERNAL INQUIRY, WE ARE NOT LOOKING TO MAKE A LEGAL DETERMINATION, THAT HAPPENS IF THERE'S LITIGATION AND THAT HAPPENS WITH OFFICE OF GENERAL COUNSEL. WITH THE ANTI-HARASSMENT STEERING COMMITTEE AND THEN SUPPORTED BY THE REPORT DR. VALANTINE TALKED ABOUT IN HER SLIDES, THE ISSUE OF GENDER HARASSMENT IS VERY SIGNIFICANT. AND WE DID NOT WANT TO LOSE SITE OF THAT AND THE IMPACT THAT THAT CAN HAVE ON THE WORK FORCE. SO WE ALSO INCLUDED IN OUR MANUAL CHAPTER INAPPROPRIATE CONDUCT. BECAUSE REALLY, THAT WAS WHAT CIVIL WAS HELPING ADDRESS ANYWAY. THIS IS EXTREMELY IMPORTANT BECAUSE OF THE AMBIENT EFFECT THAT DR. VALANTINE MENTIONED, THE THINGS THAT COULD BE SEEN AS MICROAGGRESSIONS OR NON-VERBAL THINGS THAT ARE SUBTLE AND MAYBE LEGALLY NEVER MEET DEFINITION OF SEXUAL HARASSMENT, HOWEVER HAVE SUCH AN ADVERSE EFFECT ON THE WORKPLACE AND ON THE INDIVIDUAL, SOMETHING BENEED TO BE WARE OF TO MAKE SURE WE HAVE THAT ROBUST DIVERSE EXCELLENT COMMUNITY TO PRODUCE THE WORK THAT WE DO AND MEET OUR MISSION. SO THIS IS IMPORTANT TO PAUSE OWN THAT PEOPLE CAN COME REPORT TO US, ANONYMOUSLY OR THEY CAN IDENTIFY THEMSELVES ANY TYPE OF INAPPROPRIATE CONDUCT AND WE WILL LOOK INTO IT AND HELP MITIGATE THE SITUATION. THE OTHER PIECE OF THIS I THINK THAT'S VERY IMPORTANT, IS WHAT WE WERE FINDING WITH OUTREACH IS RESPONSE TO US WAS WHAT DO WE HAVE TO REPORT AND THERE WAS SUCH A FOCUS ON NOW IS THIS SERIOUS CASE OF IF IT GOES TO CIVIL AND THE FEAR. I THINK PART OF OUR EDUCATION PARTICULARLY FOR MANAGERS IS THAT WE UNDERSTAND MANAGEMENT RIGHTS AND HOLDING PEOPLE ACCOUNTABLE AND DOING THE THINGS YOU NEED TO DO AS MANAGER. WE DON'T WANT THE STEP ON THAT BUT YOU NEED THAT OUTSIDE OBJECTIVE PERSPECTIVE TO LOOK AND SAY OKAY, IN THIS INSTANCE THIS PERSON IS BEING HARASSED BUT YOU'RE BEING REMIND TO VERIFY YOUR TIME CARD OR TO DO THE WORK YOU NEED TO DO. SO TRYING TO EDUCATE AND NOT MAKE MANAGERS FEEL LIKE WE ARE TAKING IT OUT OF OUR HANDS BUT EMPOWERING THEM THE MANAGE EFFECTIVELY AND DO THE RIGHT THING IN THE FIRST PLACE. SO THAT IS A BIG PART OF I THINK OUR COMMUNICATION STRATEGY THAT WE ARE HERE TO HELP MANAGERS ADDRESS THESE THINGS IN THE MOST EFFECTIVE WAY POSSIBLE. WHICH I THINK IS PART OF THE ISSUE, NOT JUST AT OUR AGENCY BUT EVERYWHERE, THE DIFFERENCE IN HOW PEOPLE ARE RESPONDING TO THINGS. THE OTHER PIECE OF OUR PROGRAM THAT'S BEEN REALLY EFFECTIVE IS THAT IT'S THIS MULTI-DISCIPLINARY APPROACH. WE WORK CLOSELY WITH ALL PARTNER OFFICE AND THERE'S OFFICE SIMILAR WITHIN THE DIFFERENT ORGANIZATIONS YOU ARE FAMILIAR WITH, WE WORK EXTREMELY CLOSELY WITH MANAGEMENT, POWER TRAIN HELP THEM RECOGNIZE AND HELP RESPOND EFFECTIVELY AND ALSO REPORT WHEN THEY NEED TO. WE WORK WITH EMPLOYER RELATION OFFICE WHO ARE THE ONES THAT CARRY OUT CORRECTIVE ACTION SO MIGHT RESULT IN DISCIPLINARY ACTION FOR SOMEONE THAT,s THE OFFICE THAT WORKS ON THAT AND CLOSELY WITH YOU ARE OFFICE OF GENERAL COUNCIL. WE WORK CLOSELY WITH OFFICE OF OMBUDSMAN SO I MENTIONED EARLIER WE DO RECEIVE SOME THINGS THAT DON'T FALL UNDER UNLAWFUL HARASSMENT OR COMMUNICATION DIFFERENCES, WE HAVE ENORMOUS DIVERSE ORGANIZATION SO WE HAVE SOMETIMES MISUNDERSTANDINGS SO IN THOSE INSTANCES WE DON'T SAY NOT HARASSMENT, NOT OUR PROBLEM, BECAUSE THAT WOULDN'T BE HELPFUL. INSTEAD WE TRY TO REFER THEM TO THE OFFICE TO HAVE OMBUDSMAN FOR FACILITATED COMMUNICATION, MEDIATION, THINGS OF THAT NATURE. OR SOME OTHER THINGS SUCH AS TRAINING OR COACHING OR A WIDE VARIETY OF INTERVENTIONS. WE WORKED VERY CLOSELY WITH OUR EEO OFFICE WHICH IS OFFICE OF EQUITY DIVERSITY AND INCLUSION. SO THE DIFFERENCE BETWEEN OUR PROGRAM AND THE EEO OFFICE IS THAT THE EEO PROCESS IS EMPLOYEE DRIVEN T WHETHER THEY WOULD LIKE THE FILE AN EEO COMPLIANT AND WHETHER THAT'S INFORMAL OR FORMAL. OUR PROCESS IS CARRY OUT THE NIH RESPONSIBILITY LOOK INTO EVERY ALLEGATION THAT COMES FORWARD WHICH IS REQUIRED. SO SOMETIMES THEY CAN HAPPEN IN PARALLEL, AND THAT CAN BE A LITTLE FRUSTRATING BUT IT'S IMPORTANT BECAUSE ONE IS THE AGENCY RESPONSIBILITY AND THEN ONE IS THE EMPLOYEE ELECTING TO DO SOMETHING. SO WE ARE CARRYING OUT NIH RESPONSIBILITY TO PROVIDE HARASSMENT FREE WORKPLACE. WE WORK CLOSE WITH INSTITUTE TRAINING DIRECTORS AND OFFICE OF INTRAMURAL TRAINING EDUCATION. DR. VALANTINE MENTIONED VULNERABILITY WITH TRAINEES, AND THAT'S SOMETHING THAT HAS ABSOLUTELY BEEN RECOGNIZED BY OUR STEERING COMMITTEE AND BY MY PROGRAM AND WE WORK VERY CLOSELY WITH THEM TO ENSURE THAT WHICH RESPONDS IN WAYS REVICTIMMIZE CONSIDERING WHERE THEY ARE IN LIFE STAGE, WE HAVE PEOPLE THAT LEAVE HOME AND COME FROM ALL OVER THE WORLD. SO WE NEED TO BE COGNIZANT AND THOUGHTFUL HOW WE ADJUDICATE AND ADDRESS THOSE CASES. WE HAVE ENORMOUS CONTRACT STAFF SO WE ALL -- EVERYONE IS COVERED UNDER THIS PROGRAM, TRAINEES FELLOWS FEDERAL EMPLOYEES, ESSENTIAL COMPONENT BECAUSE THOSE GROUPS FEEL A LITTLE LEFT OUT. IN THE RARE INSTANCES THINGS ESCALATE AND IN THE WORKPLACE THERE'S A SUFFICIENTTY ISSUE, WE WORK -- SAFETY WE WORK CLOSELY WITH POLICE FORCE OR JURISDICTIONS AND EMERGENCY MANAGEMENT. THE MAIN GOAL IS TO SAY LIKE DR. CLAYTON'S SLIDE, OUR GOAL IS THE SAME AS MANAGERS' GOAL. WE WANT TO PROVIDE RESPECTEDFUL WORKPLACE TO ATTRACT AND RETAIN BEST PEOPLE WE CAN IN OUR AGENCY SO COMING FROM THAT PERSPECTIVE IS KEY GETTING BUY IN FROM THE STAKEHOLDERS. DR. VALANTINE MENTIONED REPORTING TOOLS. WE HAD A CIVIL LINE ANYBODY CAN CALL THAT WENT TO ALL FEDERAL STAFF. BUT ONE OF THE THINGS WE WERE HEARING IS PEOPLE DON'T ALWAYS WANT TO TALK TO A FEDERAL HR PERSON, I GET IT. NO OFFENSE IS TAKEN BY THAT. SOMETIMES THEY WANT TO TALK TO SOMEONE THAT MAYBE IN A CALL CENTER, A CONTRACT STAFF MEMBER SO THAT'S WHAT WE DID, WE STOOD UP A HOTLINE ANYBODY CAN CALL, EVEN MEMBERS OF THE COMMUNITY THAT HAVE CONCERNS THAT MAY BE SOMEHOW RELATED TO THE NIH COMMUNITY AND THEY CAN TALK TO A CONTRACT STAFF MEMBER, SHE DOESN'T EVEN SIT WITH US, SHE DO INTAKE OR PEOPLE CAN CALL AND JUST TALK THROUGH THE PROCESS. WE HAVE PROVIDED THECAL CENTER, -- CALL CENTER, ALL THE INFORMATION. SO ONE OF THE MOST BENEFICIAL THINGS THAT I THINK HAS COME OUT OF THE HOTLINE IS SOMETIMES PEOPLE CALL AND SAY I'M NOT READY TO REPORT, WHAT'S HAPPENING TO ME, WHAT WOULD HAPPEN IF I DID, WHAT ARE OPTION? HAVING THAT VENUE IS ESSENTIAL. WE HAVE A WEB INTAKE FORM SO YOU CAN REMAIN ANONYMOUS OR PUT YOUR NAME. MOST IMPORTANTLY, WHAT WE HAVE BEEN LEARNING OVER THE LAST YEAR IS THAT IF PEOPLE AREN'T READY TO REPORT ARE THEY ARE REALLY SCARED TERRIFY OVER RETALIATION, WHATEVER THE SITUATION MAYBE THEY CAN TALK TO OFFICE OF OMBUDSMAN OR EMPLOYEE ASSISTANCE PROGRAM AND THEY ARE TOTALLY CONFIDENTIAL. SO WHAT THAT MEANS IS THEY DO NOT HAVE THE SAME REQUIRED REPORTING HUMAN RESOURCES OR MANAGER, OR FEDERAL MANAGER HAS. IF WE HEAR HARASSMENT WE ARE ON NOTICE AND HAVE TO TAKE ACTION. THOSE TWO OFFICES YOU TALK THROUGH AND THEY DON'T HAVE TO REPORT UNLESS EMINENT HARM TO SELF OR OTHERS SO HAVING A VARIETY OF PLACES TO GO, AGAIN TO TALK ABOUT OPTIONS, I THINK THAT HAS BEEN A REALLY KEY FACTOR TO SUCCESSFUL PROGRAM. PART OF O OUR PROCESS, WOULD BE WHEN SOMETHING COMES TO US WE DO INITIAL REVIEW, WE TAKE A STATEMENT FROM A PARTY, OBTAIN WITNESS STATEMENTS IF AVAILABLE. WHAT ARE WE LOOKING AT? IS THIS A MATTER OF MISCOMMUNICATION LIKE I MENTION, ACCOUNTABILITY ISSUE. IF WE DETERMINE ADMINISTRATIVE INQUIRY OR CLIENT ASSESSMENT IS NECESSARY, WHAT WE DO AT THAT POINT IS DEPENDING ON THE NATURE OF THE CASE OR HOW COMPLEX EITHER MY STAFF WILL DO INTERNAL WHERE THEY REACH OUT AND DO IT OR IF THERE'S A COMPLEX SITUATION AS DR. VALANTINE MENTION WE WORK WITH CONTRACT INVESTIGATORS, IT VARIES BASED ON THE CASE. THE OTHER CHALLENGE WE HAVE BEEN FACING AND WORKING ON WAYS TO HELP BE THE TRANSPARENCY IS THAT WHEN IT IS A HUMAN RESOURCE ISSUE WE HAVE TO TO BE CAREFUL WHAT WE SAY ABOUT CORRECTIVE ACTION IS BECAUSE WE HAVE TO PROTECT EVERYONE'S PRIVACY. THAT'S MY RESPONSIBILITY AS A FEDERAL HUMAN RESOURCES PROFESSIONAL. SO WE CAN'T SAY IN AN EGREGIOUS WAY WE'RE FIRING THE PERSON THAT DID THAT TO YOU. WE CAN'T DO THAT BECAUSE WE'RE PUTTING OURSELVES IN A LEGALLY LIABLE SITUATION. SO IN THOSE INSTANCES IT CAN BE FRUSTRATING FOR VICTIMS PARTICULARLY IN THE MOST EGREGIOUS FORMS, US SAYING WE CAN LOOK INTO IT IT'S BEEN ADDRESSED IS FRUSTRATING. WITH OUR PROGRAM WE'RE FULLY COMMITTED TO TAKING EVERYTHING SERIOUSLY EVEN IF A MORE MINOR ISSUE AND THEN DR. COLLINS DID PROVIDE SOME 2018 DATA IN A RECENT ARTICLE TALKING NUMBER OF CASES WE RECEIVED AND WHAT SOME OF THE OUTCOMES WERE IN TERMS OF ENFORMAL DISCIPLINARY ACTION BUT WE ARE WORKING ON DOING SOMETHING EVEN MORE FOR THE NIH COMMUNITY AND EXTERNAL COMMUNITY ON INTERNAL CORRECTIVE ACTION AS WELL. SO WE ARE WORKING ON THAT, YOU WILL HEAR MORE ABOUT THAT EVENTUALLY. WE HOPE TO SHOW WE TAKE THIS SERIOUSLY ADDRESSING BEHAVIOR IN THE WORKPLACE AND TRYING TO MAKE A POSITIVE CHANGE TO THE FEDERAL AGENCY. SO IF YOU WOULD LIKE MORE INFORMATION OR CHECK OUT SOME INFORMATION ON OUR PROGRAMMING, WE HAVE A TON ON THE WEBSITE, IF YOU HAVE SUGGESTIONS OR AREAS FOR IMPROVEMENT WE ARE HAPPY TO TAKE THEM. RIGHT NOW I HAVE FOUND ALL THE FEEDBACK FROM DIFFERENT SOURCES IS WHAT'S MADE THIS A STRONG PROGRAM. SO PLEASE DON'T HESITATE. THANK YOU VERY MUCH. [APPLAUSE] >> QUESTION FOR EITHER MS. HAWKINS OR DR. VALANTINE? DR. GREGORY. >> I WAS WONDERING ARE YOU TRACKING YOUR HITS FOR LACK OF BETTER WORD THROUGH THE FORMAL PROCESS VERSUS THE OH I WANT TO TALK ABOUT IT AND NOT SURE YET HOW MANY OF THOSE ACTUALLY CONVERT? >> YES. SO YOU ARE SAYING SOMEONE COMES AND WANTS TO TALK ABOUT OPTIONS. YES. WE HAVE A SCRIPT FOR HOTLINE STAFF ENCOURAGING PROTECTIONS AGAINST RETALIATION AND WHAT THE PROCESS IS TO HELP. BEWANT TO MAKE SURE PEOPLE FEEL THEY HAVE CONTROL OVER THE PROCESS SO WE DON'T FORCE IT. WE ALSO IN THE OMBUDSMAN PROGRAM DO A GOOD JOB EXPLAINING THE BENEFIT AND PROTECTIONS TO THEM. >> I WAS GOING TO SAY THIS ISSUE OF REPORTING IS VERY IMPORTANT, AND OUR EXTRAMURAL COMMUNITY RAISED INTEREST IN USING THE NIH INTERNAL SYSTEM FOR REPORTING. LAST I HEARD WE WERE GOING TO LOOK AT THIS AND CREATE THE INFRASTRUCTURE SO THAT COULD HAPPEN AS WELL. DO YOU KNOW WHERE WE ARE WITH THAT? >> YES. WE'RE IN THE PROCESS, SO SOMEONE WILL GO TO THE CIVIL WEBSITE THEY WILL BE ABLE TO -- IT'S ALMOST FINALIZED. TWO BUTTONS, ONE I WOULD LIKE TO REPORT SOMETHING DONE BY MEMBER OF THE NIH COMMUNITY AND I WOULD LIKE TO REPORT SOMETHING HAPPENING AT NIH FUNDED INSTITUTION. IT'S TWO PATHS BUT WE HAVE FOUND THEM TO BE VERY IMPORTANT. >> I DID READ THE ACADEMY OF MEDICINE OF SCIENCE ENGINEERING AN MEDICINE REPORT AND IT WAS PROFILED AT THE RECENT AAP MEETING IN CHICAGO. AND I ASKED QUESTION ABOUT STRATEGIES FOR TRANSPARENCY WHAT IS HAPPENING IN ACADEMIC MEDICINE, IS WHEN THAT'S AN ISSUE RAIDED THAT IS SUBSTANTIAL, THERE'S A LOT OF LITER -- LAWYERING UP. AND GAG CLAUSES AND THEN FACULTY AS WELL AS VICTIMS GET -- DIDN'T HEAR ANY MORE ABOUT IT. SO I BROUGHT THAT UP AND THERE WAS NO RESPONSE SO WONDERING IF FEDERAL GOVERNMENT CAN DO BETTER, SHOW LEADERSHIP AND TRY TO SOLVE THAT. IT'S A REAL -- IT'S A BAD PROBLEM. >> IN PART THIS OPENING UP OF A NEW AVENUE OF REPORTING, ATTEMPTS TO ADDRESS JUST THAT. SO THAT THEN AS SOON AS NIH IS ALERTED OF AN SITUATION IT CAN THEN BEGIN INVESTIGATING. WHAT WE MUST BE ALERTED IN SOME WAY. SO I THINK THIS WILL HELP. I DON'T THINK IT WILL COMPLETELY ADDRESS ALL THAT YOU ARE TALKING ABOUT. BECAUSE WE KNOW WHAT HAPPENS WITHIN INSTITUTIONS. I DO THINK IT WILL BE THE FIRST GOOD STEP. >> I DO RECALL HEARING SOMETHING ABOUT A GAG ORDER COMING UP SO ONE OF THE THINGS I RESPONDED, NOT SURE WHERE THE RESPONSE ULTIMATELY WENT, THERE ISN'T -- ONLY TIME THERE'S A GAG ORDER IN FEDERAL SITUATION IS IF THERE'S A SETTLEMENT AND ALL PARTIES ARE NOT SUPPOSED TO TALK OUTSIDE OF THAT. PRIOR TO SETTLEMENT THE ONLY THING WE NOT ONLY ADVISE IS IN ORDER TO PRESERVE INTEGRITY OF INVESTIGATION PROCESS, WITH DON'T WANT PEOPLE GETTING OTHER WITNESSES INFORMATION OR WHAT TO SAY. SO JUST TRYING TO ONLY TALK WITH YOUR OWN LEGAL COUNCIL OR WITHOUT SHARING WITH OTHER WITNESSES. WE DO NOT HAVE AN INTERNAL GAG ORDER TYPE THING, AT LEAST IN AS FAR AS OUR AGENCY GOES. UNLESS I'M MISS UNDERSTANDING. >> MOST PLACES NOW DO HAVE ANONYMOUS HOTLINES AS WELL AS OMBUDSMEN, WHAT HAPPENS IS THE ACCUSED GET OUTSIDE COUNCIL AND THEN THE INSTITUTIONS INSIDE COUNCIL RESPONDS. EVERYTHING IS SHUT DOWN. BECAUSE NOW IT IS FINANCIAL. >> SO THE THING ABOUT OUR PROCESS THAT I THINK HELPS WITH THAT, BECAUSE I UNDERSTAND WHAT YOU ARE SAYING, IS THAT NOW WE ARE IN BETWEEN SO MANAGERS DON'T JUST GO TO OUR OFFICE OF GENERAL COUNCIL, OUR OFFICE OF GENERAL COUNCIL REPRESENTS NIH EMPLOYEES IF RELATED TO THEIR EMPLOYMENT. HOWEVER, WE DO THE INQUIRY, WE DON'T DO IT TO PROTECT ANYONE, WE WILL GET ALL THE FACTS. AND THEN WE PROVIDE OUR INQUIRY TO THE OFFICE OF GENERAL COUNCIL. SO IF THEY FIND THERE'S WEAKNESS, THEY LET THE MANAGERS KNOW LOOK, THIS IS NOT GOOD. THIS IS BAD BEHAVIOR AND WE CAN MAINTAIN THAT REPORT SO IF THERE IS POOR BEHAVIOR ON THE PART OF MANAGEMENT WE RECOMMEND CORRECTIVE ACTION DISCIPLINARY ACTION UP TO AND INCLUDING REMOVAL FROM THE FEDERAL SERVICE. AND THE OTHER NICE PART OF OUR POLICY, THAT AT ANY POINT WE FEEL WE'RE NOT GETTING COOPERATION FROM OUR INTERNAL INSTITUTES, WE GO RIGHT TO OUR NIH LEADERSHIP AND THEY SAY I WOULD LIKE TO HEAR WHY YOU ARE NOT COOPERATING WITH THE CIVIL PROGRAM OR THEY WILL SAY CAN I SEE THIS REPORT? SO NOW THAT THERE'S THIS EXTERNAL PIECE IT'S SORT OF HAPPENING BEFORE AND ALONGSIDE OF IF SOMETHING IS GOING TO BE IN THE OFFICE OF GENERAL COUNCIL PROCESS SO THAT ACCOUNTABILITY IS STILL THERE. IT'S A STEP, IT'S A LARGER CHANGE MANAGEMENT ISSUE BUT I HAVEN'T NOTICED THAT THE LAST YEAR AS SOMETHING ENCOUNTERED. >> >> I WOULD BE INTERESTED TO HEAR WHAT YOU THINK HOW THIS SHOULD BE MANAGED. >> I THINK INSTITUTIONS NEED TO GET A SPINE. AND WE NEED TO STOP WITH THIS BAD PRIEST ISSUE. THERE'S A LOT OF CYCLING OF NOT ONLY HARASSMENT AND COERCION BUT ASSAULT AND NOBODY TALKS ABOUT IT. >> THE MOST -- (OFF MIC) >> THIS IS THE THING, EVERYBODY THINKS THE FEDERAL GOVERNMENT CAN DO SOMETHING AND IT CAN. IT DOES HAVE SIX. BUT YOU WILL BE AMAZED WHAT THE LIMITATIONS THAT WE HAVE. I WOULD SAY. WE CAN TALK ABOUT THIS OUTSIDE. >> WE ARE GETTING BENCHMARKED BY A LOT OF OUTSIDE ORGANIZATIONS AND OTHER AGENCIES. SO I THINK OUR PROCESS MEETS SOME OF THAT BECAUSE WHEN WE SEE SOMETHING NOT APPROPRIATE WE ARE LOUD ABOUT IT. >> LET ME UNDERSCORE, I THINK THE POINT YOU ARE MAKING, IS THAT WE ALL MUST WORK TOGETHER TO SOLVE THIS. THIS IS NOT ONE INSTITUTION PROBLEM, NOT JUST THE FEDERAL GOVERNMENT, WE HAVE TO COME TOGETHER TO SOLVE THIS AND ELIMINATE IT ONCE AND FOR ALL. WE HAVE THE WILL AND WE HAVE THE WORTH TO DO IT. >> LAST QUESTION FOR DR. WOOD BEFORE WE GO ON BREAK AND ANNOUNCEMENT FOR THAT. >> THE QUESTION FOR DR. VALANTINE ABOUT SURVEY, AND YOU GAVE RESPONSE RATE, DID YOU DISAGGREGATE THE DATA RESPONSE RATE BY SEX? AND RACE OR IN TERMS OF -- I KNOW IT'S CONFIDENTIAL BUT YOU HAVE DEMOGRAPHIC VARIABLES AND MAYBE WOMEN RESPONDED AT HIGHER -- >> ALL TO COME, YES. AS YOU KNOW IN GENERAL ALL THESE SURVEYS WORKPLACE, THE RESPONSE RATE FROM WOMEN IS ALWAYS HIGHER. I'M EXPECTING TO SEE SOMETHING SIMILAR. THIS IS HOT OFF THE PRESS. IT CLOSED A WEEK AGO. INVITE US BACK TO HEAR RESULTS IN DETAIL. WE'RE VERY TRANSPARENT. >> JOIN ME IN THANKING DR. VALANTINE. [APPLAUSE] >> WE WILL INVITE THEM BACK SO MORE DISCUSS. BEFORE OUR BREAK I WANT TO ACKNOWLEDGE DR. DOROTHY FINK NEW DIRECTOR OF OFFICE OF WOMEN'S HEALTH DEPARTMENT OF HEALTH AND HUMAN SERVICES. THIS IS ASSISTANT SECRETARY FOR WOMEN'S HEALTH. DELIGHT TO HAVE YOU, DR. FINK. WE WILL GO AHEAD AND BREAK IT IS MY PLEASURE TO BRING UP DR. REBECCA CARMEN WIGGINS, RESEARCH SCIENTIST AT ORWH WHO WILL INTRODUCE OUR SPEAKER. >> WELL WELCOME BACK. I WOULD LIKE TO INTRODUCE DR. NORA VOLKOW, SHE IS DIRECTOR OF THE NATIONAL INSTITUTE OF DRUG ABUSE OR NIDA, PRIOR TO JOINING NIDA, DR. VOLKOW SPENT MOST PROFESSIONAL CAREER AT DEPARTMENT OF ENERGY BROOK HAVEN NATIONAL LABORATORY IN UPTON, NEW YORK WHERE SHE HELD SEVERAL LEADERSHIP POSITIONS INCLUDING DIRECTOR OF NUCLEAR MEDICINE, CHAIR MAN OF MEDICAL DEPARTMENT AND ASSOCIATE DIRECTOR OF LIFE SCIENCES. AS RESEARCH PSYCHIATRIST AND SCIENTIST, DR. VOLKOW PIONEERED BRAIN IMAGING TO INVESTIGATE THE TOXIC EFFECT AND ADDICTIVE PROPERTIES OF ABUSABLE DRUGS. HER STUDY DOCUMENTED CHANGING IN THE DOPAMINE SYSTEM EFFECTING AMONG OTHERS, THE FUNCTION OF FRONTAL LOBE REGIONS INVOLVED WITH MOTIVATION, DRUG AND PLEASURE IN ADDICTION. UNDER DIRECTION AND SUPERVISION OF DR. VOLKOW, NIDA SUPPORTS MOST OF THE WORLD'S RESEARCH ON THE HEALTH ASPECT OF DRUG ABUSE AND ADDICTION. THE STATE OF HER TALK TODAY AS YOU CAN SEE IS GENDER IN OPIOID RESEARCH, BASIC CLINICAL AND TRANSLATIONAL IMPLICATIONS. PLEASE WELCOME DR. NORA VOLKOW. [APPLAUSE] >> THANKS VERY MUCH, THANKS TO DR. JANINE COLLATOR FOR GIVING ME THE OPPORTUNITY TO BE HERE WITH YOU TO SPEAK ABOUT OUR PRIORITIES AS IT RELATES TO THE OPIOID RESEARCH AMIDst THE CRISIS. WHAT I'M GOING TO DO IN 20 MINUTES IS GIVE YOU AN OVERVIEW WHAT IT SAYS, BASIC CLINICAL AND TRANSLATIONAL IMPLICATIONS, IN 20 MINUTES. IS SO I TRY MY BEST. WHAT IS THE BACKGROUND, WHY IS IT SO MUCH ATTENTION TO CRISIS, YOU CAN SEE HERE IN THE MAPS OF UNITED STATES WITH DIFFERENT COLORS THE PERCENTAGE MORTALITY BY COMMUNITY NORMALIZED HUNDRED THOUSAND INDIVIDUALS SO DRS IN RED HAVE HIGHEST RATES OF MORTALITY WHEN CONTROLLED FOR BASIC POPULATION. AND YOU CAN SEE THAT FROM 19199 TO 2016, THERE IS MASSIVE INCREASE IN AREAS IDENTIFIED THERE IN RED OR YELLOW, THAT CORRESPOND TO MORTALITY RATES BETWEEN 20 TO SOME PLACES 55 OVERDOSE DEATHS PER HUNDRED THOUSAND. 55 OVERDOSE DEATHS PER HUNDRED THOUSAND SO THOSE NUMBERS WE NEVER SAW IN 1999, NOT TO SAY HOW THE DISTRIBUTION IS. THIS GETS AN IDEA WHY THERE'S SO MUCH CONCERN. MORTALITY FROM OVERDOSE HAS BEEN PREDOMINANTLY DRIVEN BY OPIOIDINGS BUT IT IS NOT JUST DRIVEN BY OPIOIDS. IN THE LOWER PANEL YOU SEE THE NUMBERS ASSOCIATED WITH MORTALITY FATALITY IT IS W OPIOIDS, SEPARATED FOR MALES AND FEMALES BECAUSE IN LOOKING AT THOSE CURVES YOU GET A PERSPECTIVE OF SOME OF THE CHALLENGES THAT WE HAVE IN THE CRISIS, THAT THE THERE IS HETERO YES NAYTY IN MORE -- HETEROGENEITY BUT THE MECHANISMS BY WHICH PEOPLE ARE DYING, IT'S ALSO THAT DIRECTLY REFLECTING THAT DEMOGRAPHICS OF THOSE INFLUENCED VERY IMPORTANTLY WOMEN AS WELL AS AGE OF PEOPLE DYING FROM IT. SO 2017 IT WAS ESTIMATED CLOSE TO 48,000 PEOPLE WERE DYING FROM AN OVERDOSE FROM OPIOID THERE'S MORE THAN 72,000, MORE LIKE 78,000 PEOPLE DYING IN 2017, THAT DELTA IDENTIFY OVERDOSES FROM OTHER DRUGS SEEING SIGNIFICANT INCREASES NOT ONLY COCAINE AND METHAMPHETAMINE AND WHAT IS NOTABLE ABOUT THOSE DEATHS THEY ARE FREQUENTLY ASSOCIATED WITH SYNTHETIC OPIOIDS SO WHETHER IT IS DIRECTLY OR INDIRECTLY OPIOIDS ARE THE MAIN REASON WE HAVE THAT. BUT IT IS EXPANDING BECOMING ADDICTED TO OPIOIDS, UNBEKNOWNST TO THEM IT'S NOT A OPIOID BUT LACED WITH OPIOID. LOOK AT WOMEN AND MEN. IN ABSOLUTE TERMS, YES, MORE MEN ARE DYING THAN WOMEN BUT IF YOU LOOK AT CERTAIN DEMOGRAPHICS IN POPULATION YOU CAN START TO SEE SOME INSTANCES THE ABSOLUTE NUMBERS ARE ACTUALLY QUITE EQUIVALENT. UNDERSTANDING THOSE DIFFERENCES INFLUENCE AREAS OF INTERVENTION THAT CAN BE UNIQUELY BENEFICIAL FOR WOMEN APART FROM MOST THE OTHER INTERVENTIONS BENEFICIAL FOR BOTH GENDERS. THIS GRAPH ILLUSTRATES WHAT I WAS SAYING IN A WAY THAT AFFECTS GEOGRAPHIC DIVERSITY WE OBSERVE AS WELL AS THE INABILITY WE HAVEED THAT IN CURTAILING THE OVERDOSE FATALITIES. SO DESPITE INVOLVEMENT OF MULTIPLE AGENCIES AND INTERVENTIONS RESOURCES PLACE THROUGHOUT THE OPIOID CRISIS YOU CAN SEE AS OF LATEST NUMBER 2017 WE HAVE NOT BEEN ABLE TO DECREASE NUMBER OF FATALITIES. THES ARE REFLECTED IN THAT CURVE THE MAIN DRUGS IN OPIOID CRISIS CHANGED THROUGHOUT THE YEARS. THE OPIOID CRISIS INITIATED ABOUT THE ACTIONSER AVAILABILITY OF PRESCRIPTION OPIOIDS, THAT ACCESSIBILITY TO PRESCRIPTION OPIOIDS WAS DRIVEN BY OVERPRESCRIPTION. AND WHAT LED TO THE OVERPRESCRIPTION ARE MULTIPLE FANGTORS. CLEAR -- FACTORS. CLEARLY THE HEALTHCARE SYSTEM WAS ONE OF THE FACTORS. IT BECAME COMPLACENT IN NOT RECOGNIZING THEY KNEW BUT NOT TAKING INACCOUNT WHAT THEY KNOW OPIOIDS CAN BE VERY ADDICTIVE AND THEY ACTUALLY ARE ASSOCIATED WITH HIGH RATES OF MORTALITY. PART OF THE PROBLEM THE SAME TIME PATIENTS SUFFERING FROM PAIN AND LACK OF RECOGNITION BY THE HEALTHCARE SYSTEM AND ALL OF US ARE GOING INTO THE OTHER PENDULUM OVERPRESCRIPTION WHEN IT WAS NOT NECESSARILY APPROPRIATE. WITHOUT A PROPER EDUCATION. SO I THINK IT IS EXTREMELY IMPORTANT THAT WE UNDERSTAND MECHANIMS THAT INITIATE THE CRISIS BECAUSE IT WOULDN'T RECOGNIZE THEM WE CANNOT REVERT THEM OR AVERT THEM. THAT'S POINT NUMBER ONE. EVEN RIGHT NOW AS WE ALL KNOW OVERPRESCRIPTION OF OPIOID MEDICATIONS LED THEM TO BE FOR PATIENTS IMPROPERLY PRESCRIBE MEDICATIONS TO BECOME ADDICTED. WE RECOGNIZE THAT EVEN IF WE WERE TO COMPLETELY CORRECT IT. WE WON'T SOLVE THE CRISIS. WHY? IN 2017 YOU CAN SEE IN MA THAT BLUE THERE'S SIGNIFICANT INCREASE IN MORTALITY ASSOCIATED WITH HEROIN. THIS REFLECTS MASSIVE VERIFIED PURITY AND VERY LOW PRICE HEROIN FROM MEXICO THAT TOOK OVER THE NUMBER OF OVERDOSE DEATH SO STARTING IN 2011, BY 2017 WE SEE NUMBER OF DEATHS FROM PRESCRIPTION OPIOIDS. WHICH WERE NOT THE CASE, THE NUMBER OF OVERDOSE IN OUR COUNTRY HAVE BEEN STABLE FOR TWO DECADES AT LEAST AND STABILIZE AROUND 2000. BUT THAT JUMPS UP ALL OF A SUDDEN IN MANY 2011. AND THE MORE RECENTLY AMIDDIST 2013, THE DARKER BLUE THAT IS DRIVEN BY SYNTHETIC OPIOIDS MOST NOTABLE FENTANYL THAT IS NOT FENTANYL PRODUCED ON THE BLACK MARKET, PREDOMINANTLY FROM CHINA, THAT COMES IN TO THE UNITED STATES EITHER AS LACE HEROIN OR AS LACE PRESCRIPTION OPIOIDS OR AS LACE AS MENTIONED BEFORE COCAINE AND METHAMPHETAMINE. SYNTHETIC OPIOIDS HAVE A MUCH GREATER POTENCY AND AFFINITY FOR THE OPIOID RECEPTORS WHICH HEROIN HAS ITS EFFECTS. AS A RESULT OF THAT, THE MUCH GREATER POTENCY, FENTANYL IS 50 TIMES FOR POTENT THAN HEROIN CONSIDERING THE BINDING PROPERTIES OF RECEPTOR. THERE'S ONE ANALOG CAR FENTANYL ESTIMATED TO BE 5,000 TIMES MORE POTENT THAN HEROIN AT THE OPIOID RECEPTOR SO WHAT IT MEANS IS YOU REQUIRE SMALLER VOLUMES TO HAVE THE SAME EFFECTS. IF YOU ARE A DRUG DEALER OF COURSE, BEING ABLE TO BRING ACROSS THE BORDER IS MUCH MORE QUANTITY IS A PROPOSITION. AND IN FACT IT HAS CHANGED THE WAY THAT DRUGS GET INTO OUR COUNTRY. ONE OF THE MAIN MECHANISM IT IS SYNTHETIC OPIOIDS ARE FLOODING THE MARKET IS THROUGH THE MAIL. THAT IS CHALLENGING THE WAY WE NORMALLY REQUISITION THESE DRUGS FROM DEALERS THAT ARE MOVING LARGE VOLUMES OF DRUGS. SO THAT IS CHANGING. HOW IS THAT INFLUENCING THE DEMOGRAPHICS IN TERMS OF WOMEN? IN TERMS OF WOMEN WHERE WE HAVE TO REALIZE SO WE HAVE TO YOUR LEFT THE NUMBER OF OVERDOSES THAT IN 2016 INVOLVE BY THREE DIFFERENT WAYS THAT PEOPLE ARE DYING. PRESCRIPTION OPIOIDS, HEROIN AND SYNTHETIC OPIOIDS. IN BLUE ARE THE MALES. AND IN RED ARE THE FEMALES. EACH OF THE DIFFERENT COLORS CORRESPONDING OF COLOR DIFFERENT AGE RANGES SO IN THE LIGHTER COLOR YOU HAVE 50 TO 24, INTERMEDIATE COLORS 25 TO 44, AND THE DARKER COLORS 45 TO 64. SO IF WE LOOK AT WOMEN, THE WITH WOMEN HAVE EQUIVALENT MORTALITY TO MALES ON PRESCRIPTION OPIOIDS. BECAUSE THIS IS ACTUALLY SOMETHING THAT ONE CAN LOOK AT PARTICULARLY NOTABLE WHERE THE IN WOMEN THAT ARE 45 TO 64 YEARS OF AGE, IT WAS ACTUALLY REVERSE TRAJECTORY OF WOMEN IN THIS AGE RANGE, YOU CAN SEE THAT THE RATE WHICH THEY ARE DYING IS IN FACT SIGNIFICANTLY HIGHER THAN THAT OF MALE. SO NORMALLY SEE GREATER NUMBER OF MALES OVERDOSING BUT FOR THIS PRESCRIPTION OPIOID FOR THIS, THE RATE WHICH THEY ARE DYING IS ACCELERATING SIGNIFICANTLY MORE IN WOMEN THAN MEN. I THINK THIS OFFERS AN OPPORTUNITY IN TERMS OF TRYING TO UNDERSTAND WHAT IS GOING IN THERE AND IS VERY IMPORTANT BECAUSE WHILE WE MAKE SIGNIFICANT ADVANCES IN DECREASING MORTALITY FROM PRESCRIPTION OPIOIDS OVERALL IS BASICALLY PLATEAUING, PLATEAUING BECAUSE ACTUALLY STILL RIDING IN WOMEN AND IS NOT DECREASING. THE IMPORTANCE OF ADDRESSING IT. AND UNDERSTANDING IT. AS IT RELATES TO HEROIN YOU CAN SEE IN THE MALES, AS WELL AS IN THE FEMALES, THAT THE GROUP RATE FOR MORTALITY IS THAT ON THE JUMP, 25 TO 44. AND THAT PHENOMENA IS SAME FOR MEALSES AND FEMALES EXCEPT MUCH MORE AS WE CLASSICAL INTRODUCTION FOR MALES. BUT IF AGAIN YOU WERE TO TRACK THE TEMPORAL SEQUENCE YOU CAN START TO SEE THAT THERE ARE SIGNIFICANT INCREASES IN WOMEN ACTUALLY STARTING TO EXPERIMENT WITH HEROIN AND OVERDOSING. IN TERMS OF THE FINAL ONE TO THE RIGHT, RELATED TO THE SYNTHETIC OPIOIDS, IF YOU CAN COMPARE AGE OF SYNTHETIC OPIOIDS, AGAIN, WE ARE STARTING TO SEE A RELATIVELY HIGHER PROPORTION OF SYNTHETIC OPIOID IN WOMEN THAN IN HEROIN, ALSO LARGELY REFLECTED IN PART BY THE CONCEPT WOMEN MORE LIKELY TO TAKE PRESCRIPTION OPIOIDS MAYBE GETTING THOSE PRESCRIPTIONS WITH SYNTHETIC DRUGS LIKE FENTANYL AND OTHER ANALOGS. SO THIS IS THE CHANGE, THE TRANSLATION IN TERMS OF MORTALITY AND GENDER. WE KNOW THAT THE RECENT WHY THE NUMBER ARE EQUIVALENT IN TERMS OF MORTALITY FROM PRESCRIPTION OPIOIDS IS BECAUSE WOMEN ARE MORE LIKELY TO BE PRESCRIBED OPIOIDS THAN MEN. YOU SEE THESE GRAPH HERE WHICH REPRESENTS PERCENT OF PERSONS WITH AT LEAST ONE OPIOID PRESCRIPTION FIELD BY GENDER, IN 2017, WOMEN ARE MUCH MORE LIKELY TO BE PRESCRIBED AN OPIOID. THIS ACTUALLY ACCOUNTS WHY WOMEN HAVE BEEN PLACED IN A MUCH MORE VULNERABLE POSITION FOR BECOMING ADDICTED TO THEIR OPIOIDS AND EVENTUALLY OVERDOSING THE MALES. AND ANOTHER FACTOR I'M NOT PLACING HERE WHICH IS WOMEN ARE ALSO MUCH MORE LIKELY TO BE PRESCRIBED BENZODIAZEPINE DRUG IN COMBINATION OF BENZODRUG AND OPIOID INCREASES MORTALITY. AS WE HAVE SEEN ATTEMPTS OF ENEDUCATION OF CLINICIANS, THIS IS A LE HANGING FRUIT. THE IMPORTANCE OF HIGHLIGHTING THE NEED TO DO A PROPER DIAGNOSIS EVALUATION WHAT MAYBE THE OPIUM INTERVENTION FOR WOMAN SUFFERING FROM PAIN, AND WHAT MAYBE BE PRESCRIPTION PRACTICES AND HOW TO ENSURE THAT THEY PHOTO EVIDENCE BASED PRESCRIPTION PRACTICE INCLUDING BEING CAREFUL IN MIXING PRESCRIPTION OF BENZODIEIAS PEENS WITH OPIOID, IN PART THE REASON WHY WOMEN BEING PRESCRIBED MORE OPIOIDS THAN MAN, RELATES TO THE FACT OF ANOTHER IMPORTANT AREA OF SCIENCE, WOMEN ARE MORE SENSITIVE TO PAIN CONDITIONS THAN MALE, THIS WAS A NATIONAL ACADEMY OF MEDICINE REPORT, ON PAIN, HIGHLIGHTING THE DIFFERENCES IN THE CHRONIC PAIN SYNDROMES WHERE YOU SEE OVERREPRESENTATION OF WOMEN THAN IN MEN. YOU HAVE SEVERE HEADACHE OR MIGRAINE SIGNIFICANT NUMBER WHERE I BELIEVE PAS ARE GIVEN OPIOIDS. SIMILARLY BACK PAIN IS MORE COMMON IN WOMEN, THOUGH IT IS NOT INDICATED OPIOIDS USE IN THIS CONDITION, MANY PHYSICIANS STILL PRESCRIBE OPIOIDS. AGAIN, I DON'T WANT TO BE CATEGORICAL IN THIS STATEMENT BECAUSE ONE OF THE THINGS WE HAVE ALSO COME THE RECOGNIZE IS WE HAVE LIMITED RESEARCH ADS IT COMES TO WHAT ARE THE MOST EFFECTIVE EVIDENCE BASE INTERVENTION FOR MCMENT OF CHRONIC PAIN -- MANAGEMENT OF CHRONIC PAIN CONDITION, WE RECOGNIZE YOU URGENCY FOR MORE RESEARCH. FINALLY THE SAME NUMBERS PERTAIN FOR NECK PAIN. WHAT IS DRIVING THE PHENOMENA AND WHY WOMEN ARE MORE LIKELY TO SUFFER FROM CHRONIC PAIN CONDITIONS OR MORE WOMEN WHEN THEY START TO GET AT -- WHEN THEY GET EXPOSED TO OPIOIDS ACTUALLY TRANSITION INTO ADDICTION MORE RAPIDLY THAN MEN. WHY THERE ARE DIFFERENCES IN THE WAY WOMEN RESPOND TO THESE OPIOID DRUGS. WHEN THEY ARE ADDICTED. SOME PHENOMENA RELATE TO AREA OF OBEY SICK SCIENCE AND THIS IS ILLUSTRATED IN THE NEXT TWO SLIDES USING BRAIN IMAGING IS NOT POSSIBLE TO LOOK INSIDE HUMAN BRAIN AND QUANTIFY IN DOPAMINE DISTRIBUTION IN CONCENTRATION OF OPIOID RECEPTORS RESPONSIBLE FOR ANALGESIC ADDICTIVE AND AVERSIVE EFFECTS OF OPIOIDS. CONCENTRATION OF OPIOID RECEPTORS IN THE HUMAN BRAIN, THE COLOR SCALE REPRESENT THERE IS AREAS WITH HIGHEST CONTENT AND WITH HIGHEST CONTENT OF MU OPIOID RECEPTORS IS THE THALAMUS WHICH IS FUNDAMENTAL IN THE CONTROL AND FILTERING OF PAIN SENSATION TO UPPER CORTICAL AREAS OF THE BRAIN. ANOTHER AREA THERE WITH HIGH CONCENTRATION THAT IS NOT MAP AND ACTUALLY HERE VERY NICELY, I DIDN'T PUT -- THE AMYGDALA, AREA OF BRAIN LOADED WITH MU OPIOID RECEPTORS THAT IS IMPACTS THE EMOTION TO OUR SENSATIONS INCLUDING PAIN. IS FUNDAMENTAL FOR AVERSIVE COMPONENT OF PAIN. AND WHEN PEOPLE START RESEARCHERS INVESTIGATE ARE THERE DIFFERENCES IN THE DISTRIBUTION OF MU OPIOID RECEPTORS ON THE LEVEL OF RECEPTORS BETWEEN WOMEN AND MEN, WHAT THEY SHOWN IS THAT THERE ARE SYSTEM AREAS SIGNIFICANT DIFFERENCES PARTICULARLY AS RELATES TO THE CHANGES IN THE CIGNAING SYSTEM IN WOMEN WHICH DOWN REGULATES AS WOMEN BECOME OLDER. IT WAS NOTABLE PARTICULARLY IN THIS STUDY IS THAT TWO AREAS OF THE BRAIN, THE THAT WILL NEWS AND -- THALAMUS AND AMYGDALA, FUNDAMENTAL ONE HAND FOR FILTERING THE PAIN SENSATION AND AMYGDALA FOR EMOTIONAL COMPONENT OF PAIN, SIGNIFICANTLY DOWN REGULATED IN WOMEN. ALSO THE PERIOD MORE LIKELY TO HAVE THIS CHRONIC PAIN CONDITION OPIOID MEDICATION. AS YOU KNOW VERY IMPORTANT AREA OF RESEARCH, WHY IS IT SOME PEOPLE GO FROM ACUTE TO CHRONIC AND ONE OF THE FACTORS THAT DETERMINES THAT VULNERABILITY IS CATASTRAPHIZING. IF YOU CATASTRAPHIZE YOUR PAIN IN GENERAL PERSONALITY STYLE IS MORE LIKELY TO DEVELOP CHRONIC CONDITIONS RELATED TO SIGNALING. AS AN EXAMPLE, ANOTHER IMPORTANT DIFFERENCE, THERE ARE MANY DIFFERENCES BETWEEN MALES AND FEMALES, IN OUR BRAINS, IS THIS IS ANOTHER OPIOID RECEPTOR. IT IS NOTS A MU OPIOID RECEPTOR THAT MAKES YOU FEEL HIGH, IT'S A RECEPTOR THAT WHEN ACTIVATED GIVES YOU A GREAT SENSE OF WELL BEING. THIS IS THE KAPPA RECEPTOR SYSTEM THAT WHEN ACTIVATE GENERATE EXACTLY OPPOSITE SENSATION. SO YES WE HAVE NEURON TRANSMITTERS IN OUR BRAIN THERE TO MAKE US FEEL MISERABLE. YOU SAY WHY DO YOU WANT TO FEEL MISERABLE? BECAUSE THIS MISERABLE SENSATION INCLUDING PAIN HAVE EXTREMELY IMPORTANT PHYSIOLOGICAL ROLE. WE DON'T HAVE PAIN, WE WOULDN'T AVOID SITUATIONS OR STIMULI THAT WOULD ACTUALLY JEOPARDIZE OUR WELL BEING. WHAT'S FASCINATING, THIS IS ANOTHER BOSTON EMISSION TOMOGRAPHY STUDY MEASURING THE CONCENTRATION OF THE KAPPA RECEPTORS, IN THE BRAIN OF MALES AND FEMALES YOU CAN SEE THROUGH THE BRAIN SIGNIFICANTLY LOWER EXPRESSION OR AVAILABILITY OF THIS KAPPA RECEPTORS IN FEMALES THAN IN MALES. HOW DO YOU INTERPRET THIS DATA? ONE OF THE CHALLENGES THAT WE CURRENTLY HAVE WITH POSITRON EMISSION TOMOGRAPHY STORIES LIKE THIS ONE IS THAT WHEN YOU ARE LOOKING AT AVAILABILITY OF RECEPTOR YOU DON'T KNOW IF THE LOWER LEVELS REPRESENT THE FEMALES HAVE LESS LEVELS OF RECEPTORS OR THAT FEMALES HAVE UP REGULATION OF ENDOGENOUS LIGAND TO BIND TO RECEPTORS SO THAT PET LIGAND CANNOT BIND. IN THAT DISCUSSION OF COURSE THIS IS BORNE OUT BY AUTHORS BUT THE POSSIBILITY THAT EMERGES IS IF YOU HAVE AN OVEREXPESSION OF THE ENDOGENOUS LIGAND WHICH IS DENORFIN THAT COULD UNDERLINE DECREASE AVAILABLIBILITY OF KAPPA RECEPTORS AVAILABILITY OF KAPPA RECEPTORS AND UNDERSTANDS WHY FEMALES ARE MORE AVERSIVE EFFECTS ON NEGATIVE EMOTION OF PAIN. THAT'S GAIN IN FACT OF ANIMAL STUDIES THAT INDICATE THAT LOW AND BEHOLD IN CHRONIC PAIN CONDITION YOU SERVE THE SAME THING IN FEMALES. DOWNING ARELATION OF BINDING OF THE LIGAND, PRESUMABLY BECAUSE YOU HAVE AN UP REGULATION OF THE DINORPHIN. WHILE WE DON'T KNOW WHAT IS DRIVING THE DIFFERENCES THEY DO POINT THAT THESE OTHER RECEPTOR SYSTEM WHICH IS VERY, VERY HIGH CONCENTRATION IN THE BRAIN, DIFFERS SIGNIFICANTLY BETWEEN THE TWO GENDERS. HOW DO WE TAKE THIS INFORMATION THAT RELATES TO PAIN WE WILL BE MAKING WOMEN MORE VULNERABLE TO BE PRESCRIBED OPIOIDS AND THROUGH THAT PRESCRIPTION BECOMING MORE LIKELY TO BECOME EFFECT OR THAT BECOME MAYBE MORE VULNERABLE TO CHRONIC PAIN CONDITIONS. AS COMMENTED TO OPIOIDS WHAT ARE THE CHALLENGES WE HAVE? AND THE UNIQUE CHALLENGES WE HAVE WHETHER MALE OR FEMALE. THE REALITY OF HEALTHCARE SYSTEM IS THEY DIDN'TNIZE ADDICTION AS A DISEASE OR RECOGNIZE IT AS THEORETICAL SENSE NEVER ACTUALLY ACCEPTED IT AS PART OF THEIR JOB TO SCREEN AND INTERVENE ON FOR ADDICTION. SO THEY ARE MOST MEDICAL SCHOOL, STUDENTS ARE NEVER TRAINED HOW TO RECOGNIZE ADDICTION, NO T TO SAY EVEN HOW TO UNDERSTAND THE PHARMACOLOGY LOGIC PROPERTIES OF THESE DRUGS. SO IN THE CASE, THIS IS VERY UNFORTUNATE BECAUSE THAT WAS ANOTHER FACTOR THAT CONTRIBUTED TO THE OPIOID CRISIS. WHERE PERSONNEL WERE NOT PROPERLY TRAIN HOW TO RECOGNIZE IT. WHO WAS AT GREATER RISK IF THEY GAVE AN OPIOID OF BECOMING ADDICTED. THEY DON'T KNOW WE HAVE VERY ACTUALLY EFFECTIVE MEDICATIONS, AND TWO CLASS OF MEDICATION FOR TREATMENT OF OPIATE ADDICTION, METAPHOR MAN AND NALTREXONE. SOFT MOST EFFECTIVE THERAPEUTIC MEDICATIONS WE HAVE FOR OTHER AREAS OF MEDICINE BUT UNFORTUNATELY BECAUSE STIGMATIZATION OF MEDICATION, WHICH ARE DISMISSED BY MANY IN TREATMENT PROGRAMS, IN HEALTHCARE SYSTEMS, AMONG THE PUBLIC AND THE PATIENTS, YOU ARE CHANGING ONCE DRUG FOR THE OTHER. THAT MISUNDERSTANDING OF STIGMATIZATION IS IN PART WHAT YOU SERVE HERE. THIS IS CASCADE FOR MONITORING HIV EPIDEMIC PROJECTED INTO WHERE WE ARE WITH ADMINISTRATION OF MEDICATIONS THAT SAVE LIVES. YOU CAN SEE IF YOU WANT TO ACHIEVE NUMBER FIVE CONTINUOUS ABSTINENCE, LESS THAN 20% OF INDIVIDUALS ADDICTED TO OPIOIDS THAT GET INTO THAT STATE. SO THERE'S A HUGE GAP. WHY THE GAP? WE HAVE THE MEDICATION, WE SHOULDN'T BE THERE, NOT THAT WE HAVE THE MEDICATION JUST YESTERDAY, THEY HAVE BEEN AROUND FOR WHILE SO IF THERE'S REALLY VERY MUCH LACK OF INFRASTRUCTURE, THE LACK OF TRAINING THE LACK OF RESOURCE, UNDER STIGMA, DRIVING THE SITUATION. SO THIS HAS BECOME OF COURSE ONE OF OUR MAJOR PRIORITIES. AS WE ARE DEALING WITH RESEARCH RIGHT NOW THAT IS URGENT TO ADDRESS THE OPIOID CRISIS. I WILL TOUCH ON THE BASIS OF WHAT ARE THE UNIQUE CHALLENGES FOR WOMEN WITHIN THIS WHOLE LANDSCAPE. IT'S UNFORTUNATE IF YOU SUFFER FROM OPIOID ADDICTION. THE MORTALITY IS VERY, VERY HIGH. SO YOU NEED TO TREAT IT AGGRESSIVELY AND WHAT EVERY STUDY HAS SHOWN IS MEDICATION ARE BY FAR THE OPTIMAL INTERVENTION. YOUR OWN MEDICATION, YOUR OWN MEDICATION FOR THIS OPIOID USE DISORDER YOU ARE 70% LESS LIKELY TO DIE THAN IF YOU ARE NOT. IT'S VERY DIFFICULT TO SEE IF ANOTHER CONDITION WHERE YOU HAVE A SIGNIFICANT LEVEL OF PROTECTION. SO IF THOSE ARE THE NUMBERS, THAT IS NOT ONE STORY HERE, IT'S CONSISTENTLY WHY NOT (INAUDIBLE) MAYBE THEY HAVE NEGATIVE SIDE EFFECTS. WELL, EVERY SINGLE INDICATOR LOOKED AT INCLUDING FOR EXAMPLE NOW KNOW INDIANA OUTBREAK OF HIV, BECAUSE PEOPLE WERE INJECTING DRUGS. HAD THEY BEEN TREATED WITH MEDICATION, THAT OUTBREAK WOULDN'T HAVE HAPPENED. THE HEPATITIS C WE NEVER SPEAK ABOUT THAT BECAUSE EVERYBODY IS SPEAKING WITH FATALITIES AN OVERDOSES. BUT IT IS ESTIMATED THAT AT LEAST 40% OF INDIVIDUALS THAT HAVE EPID YOU USE DISORDER, 40% AT LEAST, HAVE HEPATITIS C. THEY ARE NOT BEING TREATED. BECAUSE NOW WE HAVE CUBES BUT NOT GIVEN THE CUBES. SO IF YOU LOOK AT THAT CASCADE OF CARE FOR TREATMENT OF OPIOID USE DISORDER, IT'S EVEN WORSE FOR HEPATITIS C, OPEN I DIDN'T DO USE DISORDER THAT HAVE RECENT ONSET OF HEPATITIS C WHICH IS THE MAJORITY OF THEM NOT BECOME GIVEN MEDICATION. MULTIPLE FACTORS ACCOUNT FOR THAT, BUT THAT'S SOMETHING WE CANNOT -- IF YOU'RE ON MEDICATION, YOU'RE MUCH U LESS LIKELY TO GET INFECTED. SO IMPROVES EVERYTHING, ACTUALLY DO SO WITH FUNCTIONING RETENTION AND TREATMENT AND IT'S SIGNIFICANTLY IMPROVE IN THE OUTCOMES IN INFANTS BORN WITH NEONATAL SYNDROME. SO LIKE TO DIVIDE THE AREAS OF RESEARCH PRIORITY AND THIS IS NOT JUST NIDA AT THIS POINT, THE WHOLE NIH, PART O WHAT WE CALL THE HEEL INITIATIVE ON SITE OF OPIOID ADDICTION, IN FOUR AREAS. ONE IS OPTIONS. WHAT IS IT WE CAN MAKE TO BE EASIER FOR A PATIENT TO REMAIN ON MEDICATION. IMAGINE BEING ATTRIBUTED TO OPIOIDS. I THINK IF -- ADDICTED TO OPIOIDS. IF YOU HAVE A CLOSE MEMBER OF THE FAMILY, IT'S ALMOST LIKE SOMEONE COMING FROM A PLANET, VERY DIFFICULT TO UNDERSTAND, WHY DESPITE NEGATIVE CONSEQUENCES SOMEONE DOES NOTS STOP THE BEHAVIOR. WE ALL HAVE A ABILITY TO STOP, LIKE A STOP SPEAKING RIGHT NOW. BUT THAT IS NOT APPROPRIATE SO I START SPEAKING AGAIN BUT SAYING IN TERMS OF CAPACITY OF DOING ANALYSIS OF SITUATION AND MAKE A DECISION ON WHAT TO SPEAK OR IN THE SPEAK AND CARRY THROUGH SO IT'S HARD FOR OUR BRAINS TO CONCEIVE OF SOMEONE THAT DOES NOT DO THAT, AND THAT HAS BEEN AT THE ESSENCE ONE OF THE DIFFICULTIES WE HAVE HAD UNDERSTAND AND FEEL IMPACTED FOR THE PERSON ADDICTED. SO WE ARE TRYING TO GET, LET'S IMAGINE BACK TO OUR EXPERIMENT IN OUR BRAINS, YOU ARE ADDICTED TO OPIOIDS, YOU WANT TO GET TREATMENT, THEY SENT SEND YOU TO THE METHADONE CLINIC. YOU HAVE TO GO EVERY DAY, THERE'S SOME MORE OR LESS 60 MINUTES AWAY AND SAY YOU CAN'T DRIVE, IF YOU DON'T HAVE A CAR, IF YOU HAVE A DAR. SO EVER DAY YOU HAVE TO GO ONE HOUR BACK AND FORTH STOW THIS METHADONE CLINIC TO GET MEDICATION SO EVERY MORNING YOU HAVE TO WAKE UP AND MAKE THE DECISION TO GO INTO TREATMENT. WOULDN'T IT MAKE MORE SENSE TO HAVE A MEDICATION EXTENDED JUST ONCE A WEEK ONCE A MONTH, EVEN SIX MONTHS, THAT'S WHERE ER ARE GOING WITH HEPATITIS C, THAT'S ONE INTERVENTION WE ARE INTERESTED IN PURSUING, AMONG OTHER THINGS. OPTIMIZE TREATMENT STRATEGIES. THEMEDCATIONS WORK. -- THESE MEDICATIONS WORK, EVEN BUPRENORPHINE PRESCRIBE, WE HAVE PHYSICIANS THAT ARE ACTUALLY HAVE THE AUTHORITY TO PRESCRIBE BUT NOT GIVING IT, HOW DO WE EXPAND THAT. HOW DO WE MAKE THE HELPER SYSTEM READY AND ABLE TO PROVIDE TREATMENTS FOR THOSE SUFFERING? 19 TO 20% INDIVIDUALS THAT HAVE OPIOID USE DISORDER WILL COME THROUGH, WITH INCREDIBLE OPPORTUNITY TO INITIATE TREATMENT. LESS THAN 5% OF THOSE SYSTEMS IS ACCESS TO MEDICATION. SO DOES IT ALL TIMES AND OTHER IMPORTANT OPPORTUNITY AND SO I KNOW EXPANDING TREATMENT IS NOT JUST HEALTHCARE BUT SETTING AND THEN OF COURSE AT THENT OF THE DAY, HOW DO WE LINK THOSE TWO SYSTEMS. A THIRD POCKET RELATED TO DEVELOPMENT, NEW IMPROVED TREATMENT STRATEGIES, I HAVE THE WORD PREVENTION THERE BECAUSE IT BEHOOVES US LIKE ANYTHING IN MEDICINE THE MOST IMPORTANT INTERVENTION THAT WE CAN DO IS PREVENT CONDITION THAT WE'RE DEALING WITH. AND IN THE CASE OF ADDICTION, WE KNOW HOW TO PREVENT. PREVENT, PEOPLE FROM EXPERIMENTING WITH DRUGS IN OPIOIDS PREVENT PATIENTS THAT ARE HIGH RISK OF ADDICTION FROM EXPOSURE TO OPIOIDS WHILE TREATING THE CONDITION. THAT IS EASIER SAID THAT DONE. SO WHY THERE'S EVIDENCE BASED INTERVENTION ABOUT WHAT REVERSE ADDICTION WORKS IN GENERAL FOR SUBSTANCE USE DISORDERS, THESE ARE NOT IMPLEMENTED AND TWO THE OTHER AREA GAP IN RESEARCH IS THAT IN THE CASE OF OPIOIDS WE ARE SEEING LOW RATES OF NATURE BUT THE NUMBERS GO UP AS THEY TRANSITION TOP (INAUDIBLE). THAT IS AN AREA WE HAVE VERY LITTLE RESEARCH, VERY LITTLE RESEARCH AS RELATES THE GENDER DIFFERENCES FOR USE OF OPIOIDS IN THESE PERIOD OF TIME WHEN RESEARCH HIGH RISK. FINALLY, I THINK THAT THE OTHER AREA THAT TRIED TO THIS COMPONENT, MANY FACES IS ONE OF THESE THEM IS THOSE OF NEWBORNS, THAT POSES ANOTHER LEVEL OF COMPLEXITY BECAUSE IT IS NOT JUST A MODEL BEING EFFECTED IN THIS CASE MODEL IS TAKING OPIOIDS, DURING PREGNANCY OR EVEN AFTER PREGNANCY THAT CHILDREN FAMILY STRUCTURE GETS DISRUPTED SO ANOTHER EXTREMELY IMPORTANT AREA. AMIDst ALL THE CHALLENGES FOR MALES AN FEMALES WHAT ARE SOME OF THE WORSE SCENARIOS FOR FEMALES? LIKE ANYTHING ELSE, FEMALES HAVE BEEN NEGLECT IN MANY FORMS. THIS IS A PAPER THAT JUST WAS BROUGHT TO MY ATTENTION, I WAS ACTUALLY HAD TO REED IT TWICE BECAUSE I COULDN'T -- READ IT TWICE BECAUSE I COULDN'T BELIEVE NUMBERS I WAS SEEING IN FRONT OF ME, WOMEN THAT DIED FROM OVERDOSE OR THEY WERE ACTUALLY DETERMINING OF THOSE OVERDOSES SO PEOPLE DIE ON AN OVERDOSE EVEN WHEN GIVEN NALOXONE SO THIS PARTICULAR STORY COMPARING FATALITIES ASSOCIATED WHICH DESPITE GIVEN NALOXONE THEY DIED AND WHAT IS REMARKABLE IS THAT IF YOU ARE A WOMAN, YOU ARE LESS LIKELY TO HAVE (INAUDIBLE) THAN IF YOU ARE A MALE. THESE NUMBERS IS EMPHASIZED SOMETHING THAT HAVE NOT BEEN IN MY RADAR, UNTIL I LOOK AT THIS AND SO IF I BASICALLY ASSUME THAT NALOXONE INTERVENTION DIDN'T DISCRIMINATE BY GENDER, THERE IS SOMETHING IN THE PROCESS THAT IS MAKING LESS LIKELY TO HAPPEN AND WE NEED TO UNDERSTAND IT. IF WE DON'T UNDERSTAND IT OF COURSE I'M REACTING BUT I NEED TO UNDERSTAND IT SO I CAN INTERVENE. COULD IT BE PERHAPS AREA I'M INTRIGUED BY WHEN YOU ARE GIVEN OPIOIDS FOR PAIN, YOU CAN OVERDOSE AND DIE. AND MANY INSTANCES OVERDOSES OCCURRING OVERNIGHT SO BECAUSE THEY OCCUR OVERNIGHT THOSE WOMEN NO ONE OBSERVE COULDN'T BE GIVEN NALOXONE OPPOSED TO A SITUATION YOU ARE OVERDOSING WITH SOMETHING LIKE HEROIN AND YOU ARE BASICALLY AMIDst A GROUP OF PEOPLE SO THIS IS RELEVANT BECAUSE THAT'S HOW WE PLAN INTERVENTIONS BUT THIS IS HIGHLIGHTING HOW UNIQUE ASPECTS RELATED TO THE WAYS SYSTEMS ARE OPERATE AND THE CONSEQUENCES. ANOTHER AREA THAT NIDA HAS BEEN INTERESTED FOR MANY, MANY YEARS, IS IF YOU ARE A PREGNANT WOMAN, STRATEGY TO TREAT OPIOID ADDICTION. THERE HAS BEEN A LOT OF CONCERN THAT METHADONE OR BUPRENORPHINE WILL BE BECAUSE YOU ARE GIVING A FULL -- PARTIAL AGONIST WITH BUPRENORPHINE AND THOSE NEWBORNS WILL HAVE SYNDROME. SO STUDIES WERE DONE TO COMPARE OUTCOMES WHEN NOT TREATED VERSUS TREATED WITH MEDICATION. AND WHAT YOU SEE OUTCOMES ARE SIGNIFICANTLY BETTER TREATED WITH MEDICATION THAN IF YOU ARE NOT. IN THIS STUDY WE ARE INTERESTED EVALUATING WHETHER THERE WERE ADVANTAGES OF USING METHADONE FOR THE TREATMENT OF PREGNANT WOMEN VERSUS BUPRENORPHINE. IN THIS STUDY PUBLISHED NOW ALMOST TEN YEARS AGO THERE WAS A SIGNIFICANT DIFFERENCE SHOWING MUCH BETTER OUTCOMES WHEN WOMEN WERE TREATED WITH BUPRENORPHINE THAN WHEN TREATED WITH METHADONE. THIS IS FOR EXAMPLE NUMBER OF HOSPITAL STAYS AT THE NEWBORN HAD TO STAY, IS BASICALLY 80% LOWER THAN TREATED WITH BUPRENORPHINE THAN WITH METHADONE AND SIMILARLY LESS THAN HALF TREATED WITH BUPRENORPHINE, WHICH BASICALLY SICK LIKELY TO REFLECT THE FACT THAT BUPRENORPHINE IS AN AGONIST AND THE WITHDRAWAL SYMPTOMATOLOGY IS MILDER SO TRANSLATE TO COST AN HEALTHCARE WHICH BASICALLY WE DID AND YOU CAN SEE THAT THAT INTERVENTION IS SIMPLE AS THAT, ACTUALLY IS NOT JUST THAT RIGHT THING TO DO FOR THEM, THE MOTHER AND INFANT BUT ALSO FOR ECONOMICALLY MAKES A LOT OF SENSE. DESPITE ALL THE ISSUES AND ALL THE EVIDENCE AND I RECOGNIZE EARLY IN MY TENURE AS DIRECTOR OF NIDA, SCIENCE IS NOT SUFFICIENT TO DRIVE POLICY OR PRACTICES. AND EVEN THOUGH THE DATA CLEARLY SHOW THAT WOMEN AND MEN THAT ARE ADDICTED ARE DOING BETTER ON EVERYTHING NOW I HAVE ALWAYS SAID FOCUS ON PREGNANCY BECAUSE IF THERE IS A LOW HANGING FRUIT, WE HAVE TO CHANGE. THE FIRST OPEN CHANGE THE REST IS PREGNANCY. AND DESPITE THE SEVERITY YOU HAVE ACTUALLY DIRECTLY TWO INDIVIDUALS AFFECTED NOT TO SAY THE WHOLE FAMILY. BUT WHEN THERE WAS THIS ANALYSIS DONE IN FOUR APPALACHIAN STATES TO SEE HOW INSURANCES PROVIDED FOR TREATMENT OF MEDICATION OF WOMEN THAT HAVE OPIOID USE DISORDER WHAT BECAME CLEAR IS DESPITE ALL THE EVIDENCE THE ASSURANCES WERE NOT COVERING FOR THE TREATMENT AND THE TREATMENT PROGRAMS WERE NOT ACCEPTING INSURANCES FOR THE TREATMENT OF THESE WOMEN. IF THEY CAME THEY WERE LESS LIKELY TO GIVE MEDICATION. THAN IF THEY WERE NOT PREGNANT. THEY WILL CONSIDER IT IF THEY WERE REVERSING OUT OF THEIR OWN POCKET. AGAIN, PROVIDING BY THAT PRACTICE TREMENDOUS ECONOMIC DISPARITY BECAUSE MANY WOMEN ARE UNABLE TO AFFORD OUT OF CASH MONEY TO PAY FOR THE TREATMENT. UNDERSTANDING THE STRUCTURAL CHANGES AND SOCIAL BARRIERS THAT EXIST IN OUR COUNTRY ARE FUNDAMENTAL FOR ADDRESSING THE UNDERTREATMENT OF INDIVIDUALS WITH OPEN I DIDN'T DO USE DISORDER AND IN PARTICULAR WHEN IT COMES TO WOMEN, PARTICULAR NEEDS TO BE WHEN IT COMES TO PREGNANT WOMEN, THIS IS AN AREA IN TERMS OF IDENTIFYING UNDERSTANDING AND DOING IMPLEMENTATION INTERVENTIONS TO CHANGE IT. THE OTHER ELEMENT IS THAT OF INFANT ITSELF, WE HAVE BEEN DOING WORK IN TERMS OF DETERMINING WHAT IS THE OPTIMAL WAY FUNDING RESEARCH, WHAT IS OPTIMAL WAY OF TREATING NEONATAL ABSTINENCE SYNDROME AND TRADITIONALLY, THE WAY SYNDROME IS TREATED IS BY GIVING MORPHINE AND DOSES ARE LOWER SLOWLY. NUMBER HAS QUADRUPLED, FROM 2004 TO 2013 THAT END UP IN INTENSIVE CARE UNIT. SO THIS IS A PROBLEM THAT IS JUST GOING IN PARALLEL WITH USING ABSOLUTE NUMBERS LOWER BECAUSE NOT SO MANY WOMEN THAT ARE GETTING PREGNANT. BUT THEY ARE -- IT IS IN TERMS OF THE BASELINE INCREASE SIGNIFICANTLY. IN THIS TELLING WHAT RESEARCHERS DID IS EVALUATE WHETHER INSTEAD OF PROVIDING WITH MORPHINE THEY PROVIDED WITH BUPRENORPHINE, BEING A PARTIAL AGONIST HAVING A LONGER HALF LIFE, MINIMIZES THE PRESENCE OF WITHDRAWAL. WHAT THEY SHOW IS SIGNIFICANTLY NUMBER OF DAYS REQUIRE FOR THE NEONATE WHEN YOU GIVE THEM BUPRENORPHINE. THAN MORPHINE SO INTERVENTION WE HAVE ARE LOW DOSE BUPRENORPHINE SIGNIFICANTLY IMPROVE THE OUTCOMES IN THE NEONATES, AND WE ARE ALSO FUNDING RESEARCH, AREA THAT IS FASCINATING, IS WHAT THE COMMUNITIES ARE DOING. MORE AND MORE WHAT HAS EMERGE IN TERMS OF HOW COMMUNITIES ARE AIMING TO TREAT OPIOID -- THE NEONATAL SYNDROME, IN NOT NECESSARILY INDICATED OPIOIDS BUT ACTUALLY PUT THEM IN AN ENVIRONMENT WHERE THEY ARE ACTUALLY HELD CLOSE TO WOMAN, THERE'S MINIMAL STIMULATION. IF YOU THINK ABOUT IT, I ALSO -- LET'S THINK ABOUT WE HAVE MU OPIOID RECEPTORS FOR MULTIPLE THINGS IN OUR BRAIN, ONE IS OF COURSE TO GENERATE CONTROL PAIN. THAT'S CLEAR. TO GIVE US A SENSE OF WELL BEING. WHAT ARE SOME OF THE THINGS THAT SOCIAL CONNECTEDNESS, SOCIAL PHYSICAL THOUGHT. WE DO KNOW THAT THE MU OPIOID REACCEPT TOES ARE FUNDAMENTAL -- RECEPTORS ARE FUNDAMENTAL FOR FORMING MEANINGFUL RELATIONS SO IF YOU DO MY STUDY RECEPTORS, THE OTHERS DON'T CARE FOR THE PUMPS AND THE PUMPS DON'T CARE FOR THE MOTHERS SO EVIDENTLY THAT PHYSICAL CONTACT IS PLEASURABLE LIKELY BECAUSE OF ENDOGENOUS OPIOID SYSTEM SO YOU ARE TOUCHING SOMEONE, YOU ARE LIKELY RAISING ENDOGENOUS OPIOIDS, AND STIMULATING THE SYSTEM. I'M SPECULATING TOTALLY BASED ON PHARMACOLOGY AND NEUROSCIENCE BUT IT IS VERY LIKELY THIS IS VERY RELEVANT, ALSO THINK WHEN YOU ARE UNDER A LOT OF PAIN OR YOU HAVE ANOTHER PERSON LOT OF PAIN WHAT DO YOU DO? YOU TOUCH THEM. SO WHAT IS IT THE PHYSICAL CONTACT IS DOING TO ENABLE US, SO UNIVERSAL OUR RESPONSE AND BIOLOGY JUST EXTRAORDINARY TELLS YOU TO DO THESE THINGS AT RANDOM. THEY DO REFLECT SOMETHING THAT IS LIKELY TO BE BIOLOGICALLY MEANINGFUL. SO IS IT'S VERY POSSIBLE IN STUDYING, NOW WHAT OTHERS OUT THERE WE CAN GIVE TO MAXIMIZE THE LIKELY HOOD, NOT ONLY INFANTS HAVE MINIMAL EXPOSURE TO NEONATAL SYNDROME BUT MOST IMPORTANTLY WAS INFANTS GO HOME AND THE MOTHER IS STILL, WHAT IS THE SOCIAL ENVIRONMENT THAT THEY WILL REQUIRE TO PROPERLY GROW UP, NOT HAVE THE VULNERABILITY ASSOCIATED, THAT WILL LEAVE THEM -- PUT THEM IN A GREATER RISK OF ADDICTION. SO WITH THAT I WANT TO END UP WITH A LAST INITIATIVE THAT WE HAVE, WE ARE VERY EXCITED BECAUSE IT IS WHAT WE CALL THE HEALING BRAIN CHILD DEVELOPMENT, THE BCD STORY. THE STORY WE ARE LAUNCHING WITH MULTIPLE INSTITUTES WHICH IMPORTANT COMPONENT IS ACTUALLY TO DO IMAGING FROM INFANCY FORWARD WITH A VERY CAREFUL CHARACTERIZATIONS OF THE FAMILY ENVIRONMENT AND MOTHER INFANT, TO UNDERSTAND HOW THE HUMAN BRAIN DEVELOPS IN CHILDHOOD, TO UNDERSTAND HOW ADVERSE SOCIAL ENVIRONMENTS IMPACT ON THE DEVELOPMENT OF THE HUMAN BRAIN, TO UNDERSTAND HOW DRUG EXPOSURE DURING PREGNANCY INFLUENCE THOSE DEVELOPMENT OF TRAJECTORIES. SO THAT STUDYING ACROSS APPROXIMATELY 8,000 CHILDREN, 20% OF THEM HAVE TO BE EXPOSED TO OPIOID DRUG DURING INFANCY, AND WILL ENGAGE MULTIPLE COMMUNITIES ACROSS THE UNITED STATES, SO THAT NOW THAT WE HAVE THE TOOLS AND CAPACITY TO INVESTIGATE ACTUALLY HOW THE HUMAN BRAIN DEVELOPS WE CAN START TO UNDERSTAND WHAT ARE THE NORMAL BRAIN TRAJECTORIES TO DO INTERVENTIONS CAN BE TAILORED FOR AGE OF THE INFANT AND CIRCUMSTANCES WHETHER THIS IS A GIRL OR A BOY. WITH THAT I WANT TO THANK YOU FOR YOUR ATTENTION. [APPLAUSE] >> THANK YOU SO MUCH FOR THAT AMAZING PRESENTATION, THE FLOOR IS OPEN FOR QUESTIONS. >> THANK YOU VERY MUCH FOR THE PRESENTATION. THERE IS A LOT OF INTEREST IN THE INTERSECTION OF PAIN AN OPIOID USE DISORDERS, VIS-A-VIS THE HEAL INITIATIVE BUT BASED ON DATA YOU PRESENTED, ONE CAN MAKE THE CASE THAT THAT INTERSECTION IS STRONGER FOR WOMEN THAN FOR MEN. OPIOID USE DISORDERS IN MEN ARE DRIVEN BY OTHER ISSUES WHICH MIGHT DICTATE ALTERNATIVE TREATMENTS FOR PAIN IN WOMEN ARE STRONGER KEY THE SUCCESSFULLY ADDRESS OPIOID CRISIS IN WOMEN. WONDER IF YOU MIGHT COMMENT ON THAT. >> I WAS HINTING AT THAT COME POINT CLEARLY TRAJECTORY IS DIFFERENT AND WE DO NOT PAY ATTENTION INTERVENTIONS WILL FAIL. CERTAINLY I WOULD SAY WOMEN ARE MORE LIKELY TO TRANSITION TO CHRONIC PAIN, TRANSITION TO CHRONIC PAIN MORE LIKELY EXPOSED TO OPIOIDS AND TO HAVE REPEATED EXPOSURE MORE LIKELY TO BECOME ADDICTED. THERE'S ANOTHER COMPONENT I DIDN'T MENTION HERE OF ALL THIS OVERDOSES THAT ARE HAPPENING AND FATALITIES IT IS ESTIMATED 20 TO 30% ARE SUICIDES. AND THAT'S LIKELY TO HAVE ANOTHER REPRESENTATION OF WOMEN. WE HAVE NOT SPECIFICALLY IN THE PAST DWELLED IN DEPTH OF THIS ISSUES. THE DATA IS NOW FORCING US TO RECOGNIZE THESE WILL REQUIRE TAILORED INTERVENTION AS WELL AS HIGHLIGHT IN MANY INSTANCES AND UNDERSTANDING OF WHAT DRIVES THEM. WITHOUT IT, YOU CAN DO THERAPEUTIC INTERVENTION, YOU HAVE SOMEONE IN EMERGENCY DEPARTMENT WHO OVERDOSED YOU GIVE NALOXONE OR BUPRENORPHINE TREATMENT IN EMERGENCY DEPARTMENTMENT IF THAT PERSON WAS SUICIDAL, AND NEVER AND YOU NEVER ASK YOU WILL HAVE THAT PATIENT COME BACK OR BASICALLY WILL NEVER COME BACK, THEY WILL OVERDOSE. SO THAT HIGHLIGHTING WHY YOU DO INTERVENTIONS. THE OTHER ASPECT TOOL THAT I WILL IN 20 MINUTES COULDN'T PRESENT BUT THE CHALLENGES THAT EMERGE WOMEN, IF YOU INITIATE MEDICATION FOR OPIOID USE DISORDER, NALTREXONE, IN SIX MONTHS, 50% PATIENT WE WAS RELAPSE. IF YOU ARE A WOMAN YOU ARE MORE LIKELY TO RELAPSE THAN MALE. THAT UNLIKELY THAT HAS TO DO WITH A LOT OF THINGS WOMEN HAVE IN TERMS OF TAKING THE RESPONSIBILITY OF THE STRUCTURE OF THE FAMILY. IF YOU DO NOT PROVIDE THE SOCIAL SUPPORT SYSTEMS THAT ARE NECESSARY FOR A WOMAN TO ENGAGE IN TREATMENT, YOU ARE NOT GOING TO SUCCEED. THIS WAS MADE TO ME, TWO MONTHS AGO I WENT TO BALTIMORE TO SIT DOWN AND MEET WITH PATIENTS ADDICTED TO OPIOIDS ASSISTING -- GOING FOR TREATMENT IN A METHADONE CLINIC AND I ASKED TO SIT DOWN AND TRY TO GET THEIR VOICES. SO I ASKED THEM THE QUESTION, WHAT WAS THE MOST CHALLENGING ISSUE FOR THEM TO SUSTAIN TREATMENT? THERE WHETHER IT WAS MEN OR WOMEN, BUT WOMEN WAS IN A MORE CRYSTAL CLEAR THAN MALE YOU CAN SEE THAT. AS NOT HAVING A PLACE TO SLEEP. IF I DON'T HAVE A PLACE TO SLEEP I HAVE TO FIND -- AND THEY HAVE CHILDREN, MANY OF THESE WOMEN HAVE, THEY HAVE TO FIND A PLACE WHERE THEY CAN GET TO SLEEP AND THAT MEANS LONG LINES, THEY HAVE TO GET FOOD FOR THE CHILDREN, AND THAT JUST COMPOUNDS THE INABILITY TO ENGAGE ON A DAILY TREATMENT ROUTINE. THAT'S THE SOCIAL CULTURAL FACTORS ARE DIFFERENT FOR MEN THAN WOMEN BUT EXTRAORDINARY IMPORTANT FOR BOTH OF THESE AND IF WE DO NOT PROVIDE A STRUCTURE THAT CAN PROVIDE RESOURCES AND PAY AND SUSTAIN THEM, IT'S HARD THEORETICALLY WE CAN SAY YOU SHOULD BE IN TREATMENT BUT PRACTICALLY BECOMES VERY DIFFICULT. >> THANK YOU SO MUCH FOR THAT EXTRAORDINARY FAR REACHING PRESENTATION. IT WAS REALLY WONDERFUL TO HEAR. I WANT TO GO BACK TO THE SUMNER ET AL STUDY THAT WAS DONE ON OVERDOSE DEATHS IN THE STATE OF RHODE ISLAND. WHEN I READ THAT STUDY I WAS REMINDED OF WHAT WE HAVE GONE THROUGH WITH REGARD TO CARDIOVASCULAR DISEASE, PEOPLE DON'T RECOGNIZE THE FACT THERE'S A LEVEL OF PERCEPTION THAT WOMEN COULDN'T POSSIBLY BE ADDICTED TO THESE VARIOUS SUBSTANCES. I WANT TO TIE THAT INTO THE LARGER NOTION OF STIGMA. EVIDENCE FROM MANY STUDIES ACROSS MANY TYPE OF SUBSTANCES SUGGEST THAT STIGMA IS GREATER FOR WOMEN THAN MEN IN TERMS OF ABUSING OR USING SUBSTANCES. THEN FINALLY, TIE THAT INTO YOUR POINT HOW TO GO FORWARD WITH SERVICES AND REDUCE RELAPSE BECAUSE AS YOU POINT OUT, THE RELAPSE RATE IS SO OR RIFFICALLY GREAT. ONE THING WE HAVE BEEN FINDING IS NOT WHETHER OR NOT YOU HAVE TO HAVE WOMEN BASE PROGRAMS, BUT YOU HAVE TO HAVE WOMEN BASE SERVICES SO CHILD CARE, DOMESTIC VIOLENCE COUNSELING, THESE IMPORTANT PSYCHOSOCIAL ASPECTS TO THE LARGER TREATMENT MODEL SO WOMEN CAN TAKE ADVANTAGE OF MAT. YOUR POINTING US IN THAT DIRECTION BUT I WANT TO EMPHASIZE THAT I THINK STIGMA AND SOCIAL RECEPTION IS REALLY A VERY IMPORTANT ASPECT OF THIS AND TO THE DEGREE NIDA CAN MAKE THIS MORE EVIDENT, I THINK IT WOULD BE EXTRAORDINARY CONTRIBUTION TO THE FIELD. >> I AGREE HUNDRED PERCENT, ONE OF THE THINGS THAT'S VERY GOOD FOR BEING PRESENTING IN FRONT OF YOU TO HEAR YOUR PERSPECTIVES BECAUSE WITHIN ALL THE DIFFICULTIES WE ARE DEALING OVERALL WITH STIGMA, THERE IS A HARDER LEVEL FOR WOMEN AND THESE BECAME -- (INDISCERNIBLE) WE BROUGHT THE PI AND SAID YOU KNOW IN MANY STATES IT MAYBE POSSIBLE FOR YOU TO GET WOMEN TO PARTICIPATE IN THIS STUDY BECAUSE THEY ARE GOING TO BASICALLY CHILD WELFARE SYSTEM, TAKE THE CHILD AWAY FROM THEM THE MOMENT THAT THEY ACTUALLY STATE THEY ADDICTED TO OPIOIDS OR ANY OTHER DRUG. AT THAT VERY ELEMENTAL LEVEL OF WOMEN FEELING NOT ABLE TO COME THROUGH AND PARTICIPATE FOR TREATMENT, BECAUSE IT IS SO STIGMA ADVERTISED THAT THEY -- STIGMATIZED THEY CAN LOSE CUSTODY OF THEIR CHILDREN AND SOME STATES YOU CAN BE PUT IN JAIL IF YOU ARE SO THIS IS THAT SORT OF THING IN TERMS OF HOW -- THE WAY I VIEW THIS, I'M -- WE ARE IN A POSITION PERSPECTIVE FROM NIDA THAT CHANGE THOSE PRACTICES AND TO ME KNOW IT SO IF WE CAN SHOW THAT A WOMAN THAT IS TREATED INSTEAD OF SENT TO PRISON, WE SHOW MUCH BETTER OUTCOME TO HER, TO HER FAMILY AND TO THE CHILD AND MUCH LESS COSTLY, THAN HOPEFULLY THOSE STATES WITH THIS VERY MEDIEVAL TYPE OF PRACTICES WILL CHANGE. BUT ONE HAS TO SHOW IN A FAIRLY LARGE IMPACT SIZE TO MAKE THESE DIFFERENCES. WE CERTAINLY ARE AWARE, THIS IS ACTUALLY -- WE DON'T WANT STATES THAT ARE EFFECTIVE NOT TO BE ABLE TO PARTICIPATE. WE DON'T WANT WOMEN, WE WANT TO EMPOWER WOMEN. WE WANT TO DO RESEARCH TO REMOVE THE STIGMA. >> DR. (INAUDIBLE). >> GREAT. I THINK THE FACT THAT WE ARE SO INTERESTED IN COMMENTING SHOWS HOW THIS TOPIC CROSSES EVERYBODY'S RESEARCH AND PRACTICE. MY CLINICAL PRACTICE, THIS JUST AS EMERGENCY PHYSICIAN, IT SPILLS OVER INTO WHAT I DO AND WHAT I SEE EVERY DAY. PRACTICING IN RHODE ISLAND WHERE THERE'S SUCH A HIGH OPIOID RELATED DEATH. IT'S PRETTY CONSIDERABLE THIS PAST WEEKEND I GAVE NARCAN TO A BOMB WHO WAS 27 WEEKS PREGNANT, SO SHE WAS BREATHING AGAIN. ONE THING YOU DID SAY ABOUT HEALTHCARE PROVIDERS ROLE IN THIS, THAT RESEARCH FIRMS THIS EPIDEMIC, I WANT TO HAVE A LITTLE COMMENT WHERE THE DRUG COMPANIES WAY BACK IN THE DAY THEY ARE THE ONES THAT TOLD US THIS WAS A NON-ADDICTING PAIN RELIEF. NOT ONLY THAT, THE JOINT COMMISSION MADE PAIN THE FIFTH VITAL SIGN SO BY MAKING SURE WE FILE JOINT COMMISSIONS RULES AND THE PAIN SCALE WENT DOWN THAT DIRECTLY RELATED TO OUR JOB PERFORMANCE. THERE IS LARGER REGULATORY ISSUE I THINK CAN BENEFIT FROM SUCH RESEARCH AS YOU ARE STATING WITH UTILIZING THE SPECIFIC SEX AND GENDER DIFFERENCES. WE ARE AS EMERGENCY MEDICINE GROUP NOW WE ARE EFFECTED MANIED TO UNDERGO -- EXPECTED TO GO THROUGH MANY HOURS OF TREATMENT. IT'S MOVEMENT AND ALSO A BURDEN FOR US TO TRY TO FIX THIS AS WELL LIKE YOU MENTIONED WE DON'T WANT THEM TO LEAVE AND COMMIT SUICIDE SO THERE'S LOTS OF SOCIAL SERVICES COMING INTO PLAY, IT'S VERY COMPLICATED. >> IT'S COMPLEX AND CERTAINLY WHY I SAY THERE'S NOT JUST ONE FACTOR THAT WAS RESPONSIBLE, BUT THERE WERE MANY FACTORS. BUT WE CREATED A SYSTEM THAT ALLOWED THE DRUG COMPANIES TO COME EDUCATE MEDICAL STUDENTS AND PROFESSIONAL AND INCENTIVIZE, WE ALLOW IT IN THE HEALTHCARE SYSTEM. BASICALLY I REMEMBER ADS MED STUDENT I KNEW OPIOIDS WERE HIGHLY ADDICTIVE AND YOU COULD ACTUALLY OVERDOSE THEY HAVE HIGH RISK BECAUSE LETHAL DOSE IS NOT FAR AWAY FROM THE THERAPEUTIC ONE I KNEW THAT YET THERE WAS A PUSH BECAUSE OF REALITY OF PATIENTS SUFFERING FROM PAIN AND WE WERE NOT PAYING ATTENTION TO THEM IT'S NOT ONE OR THE OTHER, THAT'S WHERE THE ISSUE GOT MIXED UP. I THINK WHILE THE JOINT HAVE TO HAVE THE CAPACITY TO QUESTION AS PHYSICIANS, WE OWE THE CAPACITY TO QUESTION BASED ON OUR KNOWLEDGE. SO TO ME THAT WHOLE EXPERIENCE OF WHAT HAPPENED WITH THE OPIOID CRISIS, BRINGS FORWARD THE RECOGNITION THAT AS PHYSICIANS IF WE FEEL SOMETHING IS NOT CORRECT WE NEED TO SPEAK UP. NOT JUST FOLLOW RULES BLINDLY, THIS IS ALSO PERTINENT BECAUSE WE ARE NOW OBSERVING THE PENDULUM WHERE ALL OPIOIDS ARE BAD AND WE ARE SEEING PAIN PATIENTS THAT ARE BENEFIT FROM OPIOIDS SUFFERING FROM IT SO BACK AND FORTH. WHAT YOU ARE SAYING I THINK ULTIMATELY THERE ARE ADVANCES AND IT'S EXCITING TO SEE THE EMERGENCY DEPARTMENT PHYSICIANS ARE GETTING ENGAGE WITH THE CRISIS TRYING TO BRING FORWARD NEW MODELS OF CARE. SO THAT IS A CHANGE IN THE PAST WAS NOT THERE. SO I THINK WE -- I THINK THAT IS IMPORTANT TO POINT ABOUT WHERE THINGS GO WRONG SO WE LEARN MISTAKES AND ADVANCE MORE RAPIDLY. >> SO I ALSO THANK YOU VERY MUCH FOR THAT EXCELLENT TALK. IN ADDITION TO LOOKING FOR THE SOCIAL CULTURAL FACTORS THAT ARE FOR THE REASONS WE ARE INITIATING OPIOIDS AND THEN FOR WHY THEY ARE NOT GETTING TREATMENT, I ALSO REALLY WOULD LIKE TO SEE THE DATA THAT YOU ARE PRESENTING, AGAIN SUMMER PAPERS THE ONE THAT BROUGHT IT TO MIND WHERE WE TALK ABOUT NOT NALOXONE OR NALOXONE BUT ALSO SEPARATED BY FEINT FILL FENTANYL AND CARFENTANYL LACING, THERE'S A BIG STIGMA FROM DYING FROM OVERDOSE. THE WORD OVERDOSE, I LOST A NIECE TO THIS, MY SISTER WAS VERY UPSET ABOUT THE FACT THEY CALLED IT OVERDOSE WHEN IT WAS SHOWN TO BE TREATED WITH CARFENTANYL. SO I THINK ONE OF THE BIG SEX DIFFERENCES IS HOW BIG YOU ARE AND WHETHER YOU CAN HANDLE THIS CARFENTANYL AND FENTANYL AND I DON'T THINK THE WORD IS OUT THERE ON THE STREET THERE IS LACING THAT IS KILLING, AND I SUSPECT KILLING MORE WOMEN THAN MEN BECAUSE OF SIZE, SO I ASK AS YOU PRESENT DATA YOU SEPARATE WHEN YOU SAY NALOXONE NOT NALOXONE, SHE WAS DEAD INSTANTLY SO THERE WOULD BE NO WAY ANYONE COULD DO THAT. I'M FEELING LIKE WE NEED TO TEASE APART BECAUSE YOUR GRAFTED GOES RIGHT UP TO FENTANYL AND OVERDOSE DEATHS ARE ABSOLUTELY ON TOP OF EACH OTHER. SO THE FENTANYL CAR FENTANYL THING IS -- THAT'S IN ADDITION. >> IT IS A SYNTHETIC OPIOIDS NOW THAT ARE DRIVING THE INCREASES IN MORTALITY AND IN AT LEAST 75% OF THE FATALITY IS ARE ASSOCIATED WITH FENTANYL OR ANALOGS. WE ARE INTEREST IN UNDERSTANDING WHAT IS THE BEST WAY TO REVERSE BECAUSE WHAT HAPPENS IS IF -- IS ONE OF THE CONCEPTS HAS BEEN THAT FENTANYL HAVE HIGH AFFINITY TO THE OPIOID RECEPTOR AN GET INTO THE BRAIN RAPIDLY SO BY THE TIME THE PERSON STOPPED BREATHING THEY ALMOST IMMEDIATELY HAVE INJECTION ON SITE SO YOU DON'T HAVE TIME TO INTERVENE. THE DATA IN PHARMACOLOGY SHOWS THAT RAPIDLY, MAMA LOCK ZONE DISPLACES CAR FENTANYL, THERE'S NO WAY AROUND IT. I HAVE BEEN OBSESSED IN LOOKING AT IT AND ACTUALLY TO DO THE SAME THING IN ANIMALS, DISPLACE CAR FENTANYL SO WHAT IS DRIVING THE HIGH MORTALITY? ONE IS FAST EFFECT. ANOTHER EXTREME LE IMPORTANT AREA IS MORE PEOPLE ARE MIXING DRUGS. NOT BECAUSE THEY WANT TO, BUT BECAUSE THAT DRUGS THAT THEY BUY BELIEVING HEROIN MAYBE MULTIPLE SO THEY ARE MIXING BENZODIEIAS PEENS OR ALCOHOL WITH OPIOIDS AND DRUG COMBINATIONS EXACERBATE AND AMPLIFY THE RISK OF FATALITY. THE OTHER COMPONENT TO IT, PROBABLY SEEN IT REFERRED TO IN MEDIA AND PHARMACOLOGICALLY REPORTED, IN CASE REPORT IN PHARMACOLOGY, SOME OPIOIDS HAVE DOPAMINERGIC EFFECTS AND RESULTS IN UTILITY OF THORACIC CAGE, NOT JUST DECREASING RATE OF RESPIRATION FROM THE BREATHER CENTER FROM THE BRAIN STEM BUT YOU ARE CREATING MUSCULAR RIGIDITY SO YOUR LUNGS CANNOT EXPAND. ON TOP OF THAT YOU ARE HYPOTENSIVE SO YOU NEED TO GET INJECTING NALOXONE INJECTING IT HAS TO RELY ON THE CIRCULATION TO GET INTO THE BRAIN. Z SO ALL THESE FACTORS WE ARE STUDYING TRYING TO ONE OF THE AREAS OF RESEARCH WE ARE TRYING TO GET RESEARCHERS AND COMPANIES ENGAGE IN ADDITION TO NALOXONE OR OTHER AGONISTS DRUGS THAT STIMULATE RESPIRATION OR IMPROVE THE TRANSFER OF OXYGEN TO THE AREA SO THAT YOU CAN COMBINE INTERVENTIONS THAT INCREASE THE LIKELY MOOD OF -- LIKELIHOOD OF REVERSING THE OVERDOSES THAT ARE VERY DIFFICULT, IT IS -- I MEAN AGAIN, IT'S AGAIN AS I SAID, IN HUMAN STUDIES, NALOXONE DISPLACES CARFENTANYL FROM THE BRAIN. SO THERE'S SOMETHING ABOUT THE OTHER ASPECT OF LIPID SOLUBLE DRUGS SO WHAT HAPPENS IS PEOPLE SAYING OKAY FENTANYL HAS LOWER HALF LIFE THAN NALOXONE AND LOOK AT THE PHARMACOLOGY, NOT COMPLETELY. EVEN IN ANIMAL MODELS YOU LOOK AT HYPOXIA, YOU CAN SEE FENTANYL HYPOXIA IS SHORTER THAN HEROIN. SO THERE IS A DIFFERENCE, THE IDEA IS THAT FENTANYL CAR FENTANYL MAY STAY AND THEN RELEASE WHEN NALOXONE HAS ALREADY LEFT AND THAT'S (INAUDIBLE) SO YOU GAVE NALOXONE THE PERSON BREATHESND THEN THAT I GO BACK INTO RESPIRATORY DEPRESSION. THAT IS ANOTHER COMPONENT. SO IT IS MORE COMPLEX THAN WE INITIALLY THOUGHT IT WAS. WHICH MAY EXPLAIN WHY -- I'M VERY SORRY ABOUT THE LOSS OF YOUR NIECE, IT IS -- WHAT YOU ARE SAYING IS IT IS ALSO BRINGS TO LIFE HOW TRAGIC IT IS BECAUSE EVERY PERSON THAT DIES, THINK ABOUT HOW DEVASTATING IT IS, HOW CLOSE IT IS TO ALL OF US. >> LAST QUESTION TO DR. JONES. >> THANK YOU FOR YOUR TALK. (INAUDIBLE) IT'S BEEN WONDERFUL LISTENING TO THIS TALK. WAY BACK IN THE 1970s (INAUDIBLE) PITMAN RAN AN ACUPUNCTURE CLINIC FOR WOMEN PREGNANT AND HAD ADDICTION. SINCE THEN WE HAVE SEEN REALLY A RISE IN THE INTEREST AND USE OF ACUPUNCTURE FOR PAIN. ONE OF YOUR SLIDES YOU SHOW ONE OF THE SOURCES OR MAYOR SOURCES OF PAIN, CHRONIC PAIN FOR WOMEN WERE MIGRAINE, NECK PAIN AND BACK PAIN. WHICH ARE ALSO SOURCES MANIFESTATIONS OF STRESS THAT OFTEN WOMEN HAVE. THOSE ARE ALSO AREAS THAT INSTEAD OF OPIOID TREATMENT COULD BE ADDRESSED WITH ACAI PUNCTURE AND I OFTEN WONDER AND HOPE FOR INCREASE ATTENTION BECAUSE ONE OF THE NOT KNOWN HOW ACUPUNCTURE WORKS BUT IT IS THOUGHT THAT IT STIMULATES ENDOGENOUS OPIOIDS. CERTAINLY ANYONE WHO HAS HAD EXTENSIVE ACUPUNCTURE TREATMENT CAN SAY JUST FEELING EUPHORIC AFTERWARDS SO I HOPE I WONDER I ASK AND I HOPE FOR INCREASED ATTENTION TO THIS KIND OF -- YOU MAY CALL IT ALTERNATIVE OR COMPLIMENTARY MODALITY BUT FOR THE POPULATION, IT'S MORE AND MORE GROWING AS A REASONABLE WAY TO ADDRESS PAIN AND HOPE FOR LEADERSHIP. >> GLAD YOU ARE BRINGING IT UP, IT IS DEFINITELY ONE OF THE AREAS WHERE THERE PRIORITY AREAS FOR RESEARCH, THEY CALL IT INTEGRITY, MANAGEMENT OF PAIN. THERE IS A NEW DIRECTOR FOR THE INSTITUTE OF INTEGRITY, ALLEN (INAUDIBLE) AN EXPERT ON MANY TECHNOLOGIES. SHE HAS EMBRACED THIS CONCEPT. SO ONE OF THE AREAS THE HEEL INITIATIVE WILL BE FUNDING IS THE EVALUATION OF THESE ALTERNATIVE INTEGRATIVE INTERVENTIONS FOR MANAGEMENT OF CHRONIC PAN CONDITIONS AND ALSO PERHAPS IN INSTANCES TO HELP SUPPORT MAINTAIN PATIENTS IN TREATMENT FOR OPIOID USE DISORDER. IN THE SAME LINE OF THINKING JUST LIKE ACUPUNCTURE, SO MANY STEPS IT CAN BE BENEFICIAL, IN OTHERS IT MAYBE MEDITATION, ANOTHER AREA THAT HAS EMERGE EXTREMELY IMPORTANT FOR PAIN AND OPIOID USE DISORDER IS SLEEP. IMPROVING THE QUALITY OF SLEEP IS ONE OF THE MOST IMPORTANT INTERVENTIONS THAT YOU CAN DO TO DECREASE THE INTENSITY OF PAIN. AND LIKELIHOOD PROBABLY OF RELAPSING IF YOU HAVE AN OPIOID ADDICTION. SO PHYSICAL IMPORTANCE OF PHYSICAL ACTIVITY ALSO HAS EMERGE AS ANOTHER INTERVENTION. SO THERE IS CLEAR KNOWLEDGE, ISOLATED THAT FROM RELATIVELY SMALL STUDIES THAT ALL THESE THINGS ARE BENEFIT I BELIEVE IF. -- BENEFICIAL BUT IT'S ABOUT TIME WE EVALUATE IN A LARGE COMPREHENSIVE FASHION AND COMPARE WITH OTHER OUTCOMES. SO THE NEW FUNDING WE ARE GETTING FOR HEEL WILL ALLOW TO DO SO. AND I DO PREDICT LIKE YOU THAT MANY OF THESE INTERVENTIONS WILL BE PARTICULARLY VALUABLE FOR WOMEN. ALSO FOR MEN BUT PARTICULARLY VALUABLE FOR WOMEN. >> JOIN ME IN THANKING DR. VOLKOW. [APPLAUSE] >> WE HAVE A SPECIAL TREAT FOR Y'ALL, WE HAVE A VIDEO THAT HAS SOME OF THE EXCERPTS FROM THE NATIONAL ADAD MYS -- ACADEMIES WORKSHOP. I WILL ASK THAT GET QUEUED UP. WE WILL LOOK AT THAT BEFORE WE GO ON OUR LUNCH BREAK. NATIONAL ACADEMIES MEETING IS ONE OF THE MEETINGS OF THE STUDY THAT I MENTIONED IN MY PRESENTATION. AND IT'S THE MEETING WAS ENTITLED, HIGHLIGHTED EVIDENCE BASED INTERVENTIONS TO ADDRESS THE UNDERREPRESENTATION OF WOMEN IN SCIENCE ENGINEERING AND MEDICINE. WE PUT TOGETHER A FEW PIECES. >> THIS SYMPOSIUM TODAY IS GOING TO INFORM AN ONGOING NATIONAL ACADEMY STUDY, THAT IS OPERATING UNDER AUSPICES OF OUR ABSOLUTELY FABULOUS COMMITTEE ON WOMEN IN SCIENCE ENGINEERING AND MEDICINE. THE STUDY EXAMINES SHARED AN DISTINCT BARRIERS THAT FACE WOMEN IN SPECIFIC STEM AND MEDICAL DISCIPLINES. SO IMPORTANTLY, THE STUDY GOING TO FOCUS ON UNDERSTANDING EVIDENCE BASE PRACTICES HAVE BEEN REASON IN IMPROVING THE EXPERIENCES OF WOMEN IN THESE FIELD WHILE CONSIDERING DISTINCT STRATEGY AND INTERVENTIONS MIGHT BE EFFECTIVE IN DIFFERENT DISCIPLINES. WE KNOW FROM RESEARCH MANY WOMEN STUDY OR WORKING IN SCIENCE ENGINEERING AN MEDICAL FIELDS HAVE NEGATIVE EXPERIENCE, THEY FEEL ISOLATED, THEY FEEL THEY DON'T BELONG, MANY ARE STILL EXPERIENCING HARASSMENT, MANY EXPERIENCE CONCERN OVER LACK OF INSTITUTIONAL SUPPORT. AND WOMEN OF COLOR FACE THE DOUBLE BIND. WHICH GENDER DISCRIMINATION IS COMPOUNDED BY RACIAL AND ETHNIC DISCRIMINATION. WE ARE GRATEFUL TO THE NATIONAL INSTITUTES OF HEALTH, THE NATIONAL SCIENCE FOUNDATION, L'OREAL USA FOR THEIR SPONSORSHIP OF THE STUDY, AND TO DR. JAMESSON FOR CHAIRING THE COMMITTEE OF EXPERTS AND LEADERS WHO ARE CONDUCTING THE WORK. >> WE WERE ATTEMPTING FEW YEARS AGO TO DETERMINE HOW WE COULD BEST RESPOND TO SOME COMMENTS MADE BY A THEN PRESIDENT OF A OUTSTANDING UNIVERSITY IN THE NORTHEAST WHEN HE SUGGESTED PERHAPS THE REASON DIDN'T EXCEL IN MATH AND SCIENCE WAS BECAUSE OF LACK OF INNATE ABILITY. WE WERE TRYING TO THINK OF A WAY TO RESPOND BECAUSE BEING THE NIH WE HAVE TO HAVE A DATA DRIVEN RESPONSE, AND IT NEEDED TO BE UNEMOTIONAL IN SPITE OF HOW WE FELT AND WE WERE JUST TRYING TO THINK HOW ARE WE GOING TO DO THIS? WHEN WE WERE CONTACTED BY SOMEONE FROM NATIONAL ACADEMY HELPING TO SPONSOR A COMMITTEE STUDY ON BARRIERS TO WOMEN IN SCIENCE ENGINEERING AND MEDICINE. DR. ZERHOUNI THEN DIRECTOR OF NIH GAVE ME A CALL. HE TOLD ME HE RECEIVED A CALL FROM DON SHELALA WHO CHAIRED THE COMMITTEE, HE HEARD ABOUT THIS REPORT. AND THAT SHE TOLD HIM NOT TO LET THIS BE ANOTHER REPORT TO JUST SIT ON THE SHELF. BUT TO DO SOME THING OF VALUE WITH IT SO HE WAS CALLING ME TO SEE WHAT WE COULD DO. THAT WAS PERFECT. THERE IT WAS FROM THE TOP DOWN. WE WERE GOING TO DO SOMETHING AT NIH. DR. ZERHOUNI FORMED A REPRESENTATIVE NIH COMMITTEE CALLED WOMEN IN BIOMEDICAL CAREERS. THIS COMMITTEE WOULD BE ASKED TO RESPOND TO THE CHALLENGES ISSUED TO GOVERNMENT FUNDING AGENCIES IN THE REPORT TO MAXIMIZE THE POTENTIAL OF WOMEN SCIENTISTS AND ENGINEERS. HE INSTRUCTED THE WORKING GROUP TO CONSIDER THE RECOMMENDATIONS IN THE REPORT AND THIS WAS HIS LANGUAGE, TO DEVELOP INNOVATIVE STRATEGIES AND TANGIBLE ACTIONS THAT COULD BE IMPLEMENTED TO PROMOTE ADVANCEMENT OF WOMEN IN RESEARCH CAREERS, BOTH WITHIN THE NIH INTRAMURAL COMMUNITY AND THROUGHOUT THE EXTRAMURAL RESEARCH COMMUNITY. WAS THUS BORN THE NEW INITIATIVE WHICH CONTINUES TO THIS DAY, NOW CO-CHAIR BY DR. JANINE CLAYTON, DIRECTOR OF ORWH AS YOU KNOW, AND DR. FRANCIS COLLINS, THE CURRENT NIH DIRECTOR. SO OUT OF THAT CAME WHAT WAS REFERRED TO AS THE CAUSAL FACTORS AN RFA THE FIRST OF ITS KIND FOR NIH FUNDED 14 UNIVERSITY PROGRAMS TO DETERMINE DATABASED INTERVENTIONS PROVEN SUCCESSFUL AS RECOMMENDATIONS WE THOUGHT HELP NIH KNOW WHAT NEW PROGRAMS IT SHOULD DEVELOP AND IMPLEMENT. >> WHEN THE NATIONAL ACADEMY CALLED ME AND SAID WOULD YOU CHAIR THIS REPORT, I SAID I'M NOT AN ENGINEER OR SCIENTIST, WHY DON'T YOU GET ONE OF THE DISTINGUISHED SCIENTISTS TO CHAIR THE REPORT? THEY SAID NO, WE NEED SOMEBODY TO MANAGE THE SCIENTISTS AND THE ENGINEERS. WHAT WE WERE TRYING TO DO WAS DEVELOP A SOPHISTICATED CONCEPTUAL FRAMEWORK SO THAT EFFORTS IN THE FUTURE HAD A CONCEPTUAL FRAMEWORK TO MOVE WITHIN BECAUSE WE KNEW WELL AND YOU ARE HEARING IT IN THE PANELS THAT ALL SORTS OF PROGRAMS WOULD BE CREATED TO IMPLEMENT BASIC GOAL. REPORT. THE FUNDAMENTAL PRINCIPLE WAS THIS COUNTRY AND THE WORLD WOULD NOT BE THE DYNAMIC ECONOMICALLY SUCCESSFUL COUNTRY IT WOULD BE UNLESS IT TOOK ADVANTAGE OF ALL ITS TALENT. IT WAS AS SIMPLE AS THAT. IT WAS A QUESTION OF USING ALL OF THE TALENT IN OUR SOCIETY. WE DIDN'T HAVE SMALL GOALS. WE THOUGHT THAT WE WERE REALLY DETERMINING THE FUTURE OF THE UNITED STATES. BY CONTINUING THE JOURNEY THE WOMEN'S MOVEMENT STARTED, BUT IN FAR MORE SOPHISTICATED WAY. AT IN FACT IT WAS THE RIGHT RESEARCH UNIVERSITIES THAT WERE UNDERPERFORMING IN BOTH ATTRACTING, RETAINING, AND PROMOTING WOMEN IN SCIENCE. AND THAT IT COULD NOT BE DONE UNDER THE TRADITIONAL TRACKS, THEY HAD TO PAY ATTENTION TO FAR MORE DETAIL THAN THEY EVER PAID ATTENTION BEFORE. SO WE ACTUALLY TOOK ON NATIONAL ACADEMY OF SCIENCES REPORT, THE GREAT RESEARCH UNIVERSITY IN THE UNITED STATES. AND SAID WITHOUT THEIR LEADERSHIP IN THIS AREA, NOT A CHANGE WE WERE GOING TO CHANGE, OUR WEAKNESS IS LEAD SHIP IN HIGHER EDUCATION. NOT THE LEADERSHIP IN SCIENCE. BUT HIGHER EDUCATION. WE HAD AS MANY CHALLENGES WITH WOMEN LEADERS AS WE HAVE WITH MEN LEADER. IT DOES NOT GUARANTEE ANYTHING TO SELECT A WOMAN AS THE HEAD OF A GREAT INSTITUTION. THEY HAVE TO BE COMMITTED AND THEY HAVE TO SEE THIS AS PART OF THEIR OWN PORTFOLIO. I'M PROUD OF THE RESULTS OF THIS REPORT. I'M PROUD WE MADE SOME PROGRESS, WE WILL NEVER MAKE ENOUGH PROGRESS TO SATISFY ANY OF US. BUT AT LEAST IT GAVE SOME FRAMEWORK FOR IT AND AT LEAST IT COMMITTED THE NATIONAL ACADEMIES. YOU CAN'T BE WORLD CLASS UNLESS YOU HAVE DIVERSITY. I NEVER BACKED AWAY FROM THAT CONCEPT. IN THE SAME WAY I NEVER BACKED AID WAY FROM WE CANNOT HAVE A DYNAMIC ECONOMY UNLESS WE USE ALL OUR TALENT. WE OPERATIONALIZE THE REPORT SO WE IDENTIFY THE CONSTITUENCIES AND INSTITUTIONS NEEDED TO TAKE UP PARTS OF THE REPORT. AND WE FOLLOWED UP WITH THOSE INSTITUTIONS. SO THE LAST PART OF THE REPORTS HAVE TO IDENTIFY WHAT THE FEDERAL GOVERNMENT SHOULD BE DOING IN TERMS OF ACCOUNTABILITY, WHAT THE STATE GOVERNMENTS MIGHT DO, JUST DEPEND ON WHAT IT IS. AND WHAT YOU EXPECT FROM AMERICAN BUSINESS. THEN YOU HAVE TO IDENTIFY THOSE CONSTITUENCIES AND FOLLOW-UP. ALL THIS HAS CONSTANTLY REQUIRED STRUCTURAL CHANGE IN THE ACADEMY. AND RESEARCH ENTERPRISE OF THIS COUNTRY. AND MANY OF THESE INSTITUTIONS HAVE CHANGED. AND V WORKING ON THESE ISSUES FOR A VERY LONG TIME. BECAUSE THEY WANT TO KEEP TALENTED PEOPLE, WE DON'T HAVE ENOUGH MOVEMENT. THAT'S WHAT THIS MEETING IS ALL ABOUT. >> SO WE JUST WANTED TO SHARE A LITTLE BIT ABOUT THAT CONFERENCE WITH YOU, IT IS AVAILABLE AT THE NATIONAL ACADEMIES WEBSITE, NOT THE FULL CONFERENCE BUT MUCH IS. SO YOU HAD A WHIRLWIND MORNING, WE ARE JUST A LITTLE OVER. BEFORE WE BREAK FOR LUNCH, WHICH WE ARE GETTING READY TO DO, I WOULD LIKE THE ADVISORY COMMITTEE MEMBERS TO MEET ME OUTSIDE ON THE STAIRS SO THAT WE CAN DO OUR PHOTO. I WILL RECONVENE US, WE HAD A NICE LUNCH AND WE HAVE A NICE LINEUP IN THE AFTERNOON FOR YOU. I WILL ASK DR. -- TO COME TO THE PODIUM AND TO INTRODUCE OUR NEXT SPEAKERS. >> THANK YOU, GOOD AFTERNOON. I'M PLEASED TO WELCOME MS. DAWN CORBETT, NIH INCLUSION POLL OFFICER OFFICE OF EXTRAMURAL PROGRAMS. TO ENSURE INCLUSION OF WOMEN MINORITIES AND INDIVIDUALS ACROSS THE LIFE SPAN IN IDENTIFYING CLINICAL RESEARCH. PRIOR TO JOINING OER MS. CORBETT SPENT 40 YEARS AT NIMH WORKING ON TRANSPARENCY RESEARCH AN COORDINATING NIMH PROGRAMS RELATED TO DIVERSITY AND INCLUSION. TODAY DAWN WILL SHARE WITH US A DIFFERENT TRIAL AND INCLUSION REPORT. WITH THAT, PLEASE HELP ME WELCOME DAWN. >> THANK YOU. GOOD AFTERNOON, EVERYONE, TODAY I'M GOING TO TALK ABOUT THE INCLUSION OF MINORITIES AND INCLUSION ACROSS THE LIFE SPAN, OUR GOALS ARE TO UNDERSTAND CHANGES TO POLICIES AND PROCEDURES HERE AT NIH REGARDING INCLUSION OF WOMEN MINORITIES AND INDIVIDUAL ACROSS THE LIFE SPAN AND NIHED CLINICAL RESEARCH. WHILE REVIEWING STATUS OF GAO RECOMMENDATIONS RELATED TO INCLUSION OF WOMEN AND MINORITIES AND INCLUDE INCLUSION DATA FROM FISCAL 2015 TO 2018 MINORITIES AN NIH FUNDED CLINICAL RESEARCH. FINALLY, AT THE END OF TALK WE'LL WRAP BY LEARNING ABOUT RECENT CHANGES TO THE COMMON RULE. TO GET STARTED I JUST WANT THE GIVE YOU ALL A TIME LINE OF THE NIH INCLUSION POLICY NIH HAS POLICY ON INCLUSION SINCE 1986 WHEN WE ESTABLISHED A POLICY TO INCLUDE WOMEN IN STUDIES. THIS BECAME LAW. IN 1993 THAT REVITALIZATION ACT INCLUDED A REQUIREMENT THAT WOMEN AND MINORITIES BE INCLUDED IN ALL CLINICAL RESEARCH UNLESS THERE WAS COMPELLING RATIONALE FOR EXCLUSION. IN 1998 WE ISSUED A POLICY REQUIRING INCLUSION OF CHILDREN AT NIH CLINICAL RESEARCH. AND WE AMENDED THIS POLICY SLIGHTLY IN 2015 BY CHANGING THE DEFINITION OF CHILD, FROM INDIVIDUAL UNDER 21, TO INDIVIDUAL UNDER 18. THE LAST FEW YEARS WE HAVE SEEN A LOT OF CHANGES IN POLICIES AND PROCEDURES ON INCLUSION MANY RELATED TO THE 21st CENTURY CURES ACT WHICH WAS PASSED IN DECEMBER OF 2016. WHICH INCLUDED NEW REQUIREMENTS FOR INCLUSION AND REPORTING OF DEFERENCES BASED ON RACE GENDER ETHNICITY AND AGE. SOME OF THOSE CHANGES IN 2017 WE REQUIRED NIH DEFINED PHASE 3 CLINICAL TRIALS REPORT RESULTS OF SEX GENDER RACE AND ETHNICITY AND ANALYSES IN CLINICALTRIALS.GOV AND SUPPLIED APPLICABLE TRUST CLINICAL TRIALS AND MOST RECENTLY A FEW MONTHS AGO IN JANUARY OF 2019 NIH INCLUSION ACROSS THE LIFE SPAN POLICY BECAME EFFECTIVE WHICH NOW REQUIRES THE INCLUSION OF INDIVIDUALS OF ALL AGES. AND NIH CLINICAL RESEARCH UNLESS SCIENTIFIC REASON FOR EXCLUSION. SO I WILL FLESH OUT NOW SOME OF THOSE MORE RECENT CHANGES. I MENTION THE 21st CENTURY CURES ACT AND THERE WERE A NUMBER OF CHANGES TO INCLUSION AS A RESULT OF THE 21st CENTURY CURES ACT. SOME OF THESE CHANGES I LISTED ON THE SLIDE. SOME REQUIREMENTS WERE RELEVANT TO AGE GROUPINGS WE REQUIRE BY 21st CENTURY CURES TO CONVENE A WORKSHOP ON AGE GROUPINGS AND EXCLUSION. WE EXAMINE GUIDELINES ON AGE AND PUBLISHED DATA ON AGE OF PARTICIPANTS AND NIH CLINICAL RESEARCH. WE HAD OTHER REQUIREMENTS RELATED TO REPORTING. REQUIRED TO ASSEMBLE PARTICIPANT INCLUSION DATA DISAGGRAVATED BY RESEARCH AREA -- AGGREGATED BY CLINICIAN AND DISEASE CATEGORY AND FINALLY THERE WAS A REQUIREMENT THAT APPLICABLE CLINICAL TRIALS REPORT RESULTS OF VALID ANALYSES BY SEX GENDER RACE EAT IN THISTY AS ACCORDING TO CLINICALTRIALS.GOV. SO THERE'S QUITE A LOT IN 21st CENTURY CURES WE GOT BUSY ON IMPLEMENTATION. ONE PIECE WAS INCLUSION ACROSS THE RIFE SPAN WORKSHOP JUNE 1, 2, 2017 HERE IN BETHESDA. FORTUNATELY WE WERE ALREADY IN THE PROCESS OF PLANNING THIS WORKSHOP IN 21st CENTURY CURES WAS ENACTED AND SO WE WERE ABLE TO HOLD IT WITHIN THE REQUIRED TIME FRAME SO THE PURPOSE WAS DISCUSS CHALLENGE AND BARRIERS TO INCLUDING CHILDREN AND OLDER ADULTS IN CLINICAL TRIALS. ALSO IDENTIFY STRATEGIES FOR MORE AGE INCLUSIVE TRIALS. SO THIS WORKSHOP IS WELL INTENDED, WE HAD OVER 200 PARTICIPANTS THEY REPRESENT PROVIDERS PRACTITIONERS, ALSO ADVOCATES, WE HAD NUMBER OF SCIENTISTS FROM ACROSS THE COUNTRY TO PARTICIPATE IN THE WORKSHOP, WE HEARD FROM DR. FRANCIS COLLINS YOU CAN SEE HERE IN A NUMBER OF IC CORRECTORS AND PARTICIPATION FROM SCIENTISTS THROUGHOUT THE COUNTRY. SO THIS WORKSHOP CAME UP WITH A WORKSHOP AVAILABLE ON OUR WEBSITE BASED ON FEEDBACK FROM THE WORKSHOP AND SOLICITED THROUGH REQUEST FOR INFORMATION FROM THE GENERAL PUBLIC NICHD DEVELOPED INCLUSION ACROSS THE LIFE SPAN POLICY. AS I MENTIONED, THIS POLICY BECAME EFFECTIVE RECENTLY. IT'S EFFECTIVE FOR APPLICATION SUBMITTED DUE DATES JANUARY 25, 2019 OR LATER. THOUGH IT'S RECENTLY BECOME EFFECTIVE WE DID ISSUE THE NOTICE OF THE POLICY BACK IN DECEMBER 2017 TO MAKE SURE FOLKS HAD ENOUGH TIME TO PREPARE FOR THIS POLICY. SO WHAT'S DIFFERENT? INDIVIDUALS OF ALL AGES ARE REQUIRED TO BE INCLUDED IN NIH FUNDED RESEARCH UNLESS THERE IS A SCIENTIFIC OR ETHICAL REASON NOT TO INCLUDE THEM. SO THIS WAS REVISION OF INCLUSION OF CHILDREN POLICY BUT WE ARE LOOKING AT INDIVIDUALS ACROSS THE ENTIRE LIFE SPAN. WHAT IS THE INTENT OF THE POLICY? INCLUSION AND EXCLUSION CRITERIA BASED ON AGE TO BE THOUGHTFUL, THERE SHOULD BE A REASON MIND THEM. WE WOULD LIKE TO GET AWAY FROM COPY AND PASTE UNCOLLUSION AND EXCLUSION CRITERIA. IF AGE RANGE 18-65 THERE SHOULD BE SCIENTIFIC ETHICAL REASON FOR THAT AGE RANGE. FINALLY THE POLICY REQUIRES SUBMISSION OF INDIVIDUAL LEVEL PARTICIPANT DATA IN PROGRESS REPORTS. SO THIS IS A NEW REQUIREMENT 21st CENTURY CURES WE REQUIRE ON NIH. THIS IS QUITE A BIT OF DEATH AND WE HAVE SEX GENDER RACE ETHNICITY AND NOW AGE, WE WANT TO MAKE IT EASY FOR INVESTIGATORS AND STAFF AS WE COULD BUT GOT THE REQUIRED DATA. WE FELT EASIEST WAY IS HAVE FOLKS SUBMIT A SPREADSHEET OF INDIVIDUAL DATA. SO WE HAVE A SPREADSHEET OF PARTICIPANTS SEX OR GENDER RACE ETHNICITY AND AGE AT ENROLLMENT AND THIS IS SUBMITTED TO NIH IN PROGRESS REPORTS, THESE ARE DEIDENTIFIED, WE DO TREAT THEM AS PII THOUGH WE ARE NOT GETTING IDENTIFYING INFORMATION BECAUSE OF THE AMOUNT OF INFORMATION WE ARE GETTING ABOUT INDIVIDUAL PARTICIPANTS. JUST REVIEW OF THE NEW REQUIREMENTS, INCLUSION ACROSS LIFE SPAN POLICY, THE INCLUSION ACROSS LIFE SPAN POLICY REQUIRES THAT APPLICATIONS OR PROPOSALS INCLUDE PLAN FOR INCLUSION PREVIOUSLY APPLICANTS WOULD INCLUDE A PLAN FOR INCLUSION OF CHILDREN TO ADDRESS AGE AND NOW THAT PLAN IS FOR INCLUSION OF INDIVIDUALS ACROSS THE LIFE SPAN. IF EXCLUDED BASED ON AGE THEY PROVIDE RATIONALE AND JUSTIFICATION FOR AGE SPECIFIC AGE RANGE. PROGRESS REPORTS ADS I DISCUSSED THE POLICY REQUIRES THE AGE OF PARTICIPANTS AT ENROLLMENT TO BE INCLUDED IN THOSE REPORTS. THAT MEMBER RECORD IN UNITS RANGING FROM HOURS TO YEARS. WE HAD CHANGES IN WOMEN AND MINORITIES, POLICY FA YOU ARELY RECENTLY, IN -- FAIRLY RESENTLY, IN 23017 WE AMENDED INCLUSION WOMEN AND NIGH MORETIES POLICY AFFECTED FOR COMPETING AWARDS ON OR AFTER DECEMBER 13th 20, 17. IT REQUIRES APPLICABLE NIH DEFINED PHASE 3 CLINICAL TRIALS REPORT RESULTS OF ANALYSES BY SEX OR RENDER AN RACE ETHNICITY TO CLINICALTRIALS.GOV. WE HAD POLICY FOR SOME TIME SINCE 1993 NIH DEFINED PHASE 3 PLANS TO DO THESE ANALYSES. WHAT IS DIFFERENT ABOUT THIS REQUIREMENT IS APPLICABLE CLINICAL TRIALS, GENERALLY FDA REGULATED DEVICE TRIALS HAS PHASE 3, THEY HAVE ADDITIONAL REQUIREMENT THEY HAVE TO REPORT THE RESULTS OF THOSE ANALYSES TO MAKE THOSE AVAILABLE TO THE PUBLIC AND RESEARCH COMMUNITY. IN CLINICALTRIALS.GOV. LOTS OF CHANGES BASED ON 21st SENT ARE CURES BUT ALSO UPDATE YOU THE STATUS OF JO RECOMMENDATIONS ON INCLUSION. IN OCTOBER 2015, GAO ISSUED A REPORT ON INCLUSION OF WOMEN AND MINORITIES TITLED BETTER OVERSIGHT NEEDED TO HELP ENSURE CONTINUED PROGRESS INCLUDING NIH IS WORKING ON IMPLEMENTING RECOMMENDATIONS RELATED TO THIS REPORT. SINCE 2015. SOME OF THE RECOMMENDATIONS ARE OPEN, SOME CLOSED SO I'LL GO THROUGH EACH. THE FIRST RECOMMENDATION WAS TO MAKE IC LEVEL ENROLLMENT DATA READILY AVAILABLE THROUGH PUBLIC MEANS. THIS RECOMMENDATION IS CLOSED, WE DO HAVE ON OUR WEBSITE, YOU CAN GO LOOK AT ENROLLMENT REPORTS FOR ANY IC. THE SECOND RECOMMENDATION WAS TO EXAMINE APPROACHES FOR AGGREGATING DETAILED ENROLLMENT DATA AT DISEASE AND CONDITION LEVEL. THIS WAS ALSO IN 21ST CENTURY CURES, INCLUDED A REQUIREMENT FOR DATA BY RESEARCH DISEASE AND CATEGORY, I WILL TALK MORE ABOUT ADDRESSING THE RECOMMENDATION ON THE NEXT SLIDE. THE THIRD RECOMMENDATION WAS TO ENSURE THAT PROGRAM OFFICERS HAVE A MEANS OF RECORDING MONITORING OF PLANS FOR AND PROGRESS IN CONDUCTING ANALYSES OF SEX DIFFERENCES. THIS ONE IS CLOSED SO WE IMPLEMENTED A COUPLE OF YEARS AGO A CHANGE TO OUR PROGRAM CHAT LIST WHICH ALLOWS PROGRAM OFFICERS TO INDICATE WHETHER ANALYSES ARE REQUIRED BY SEX GENDER RACE ETHNICITY FOR NIH PHASE 3 CLINICAL TRIALS. RECOMMENDATION 4, RELATES TO THAT RECOMMENDATION 4 IS ON REGULAR BASIS SYSTEMATICICALLY COLLECT ANALYZE SUM I DATA REGARDING AWARDEES PLAN FOR ANALYSIS OF POTENTIAL SEX DIFFERENCES SO WE NEED TO BE ABLE TO EXTRACT DATA WE ARE ABLE TO DO FROM THE PROGRAM CHECKLIST BASED ON THE ANSWER OF THE PROGRAM OFFICER. FIVE IS REPORT THE DATA P SO WE EXPECT RECOMMENDATIONS TO BE ADDRESSED ON TRAINING REPORT, PREPARE THE TRIANNUAL REPORT SET FOR ADVISORY COUNCIL WHICH ADDRESSES PLANS FOR SEX DIFFERENCES. SO ONE OF THE RECOMMENDATIONS I TALKED ABOUT I I TOUCHED ON IN 21st SENTENCERY CURES WAS ABILITY TO REPORT INCLUDES DATA BY RESEARCH CONDITION AND DISEASE CATEGORY. WE CALL RCDC CATEGORIES INTERNALLY. THIS IS SOMETHING WE HAVE BEEN WORKING ON FOR SOMETIME, WE HAVE ABOUT 281 RCDC CATEGORIES AND 21st CENTURY CURES DID REQUIRE E PROVIDE DATA FOR EACH IC AND ASK WE PROVIDE DATA ON THE PROPORTION AND NUMBER OF PARTICIPANTS WHO WERE FEMALE AND NUMBER OF MEMBERS OF NORDIC GROUPS SO WE HAVE DONE THAT, WE HAVE A WEBSITE AVAILABLE THE LINK IS AVAILABLE ON THE SLIDE AND MANY CAN CLICK ON THE LINK TO GO AND LOOK AT INCLUSION DATA BY RESEARCH CONDITION RANS DISEASE CATEGORY. YOU CAN SEE THE FIRST CATEGORY ALS YOU CAN CLICK THAT AND GET MORE DETAILED INFORMATION ABOUT THE RESEARCH PARTICIPANTS AND ALS RESEARCH FROM ACROSS NIH AT THE VARIOUS INSTITUTES. IF YOU DO GO AND PLAY AROUND THE DATA I ENCOURAGE I THINK IT'S FUN BUT I DON'T KNOW IF EVERYTHING ELSE DOES, IF YOU GO TO WEBSITE YOU ON THE FIRST PAGE MEDIAN PROPORTION OF PARTICIPANTS. WHY INCLUDE MEDIAN PROPORTION? TO GIVE A SENSE WHAT A TYPICAL NIH STUDY LOOKS LIKE. AS I'LL PRESENT DATA TO YOU YOU WILL SEE BECAUSE OUR STUDIES ARRANGE ANYWHERE FROM ONE PARTICIPANT TO OVER A MILLION PARTICIPANTS, THEY'RE EASILY SKEWED BY ONE LARGE STUDY. SO WE WANTED TO MAKE SURE YOU HAD A REPRESENTATION OF WHAT DOES A TYPICAL STUDY LOOK LIKE. YOU SEE THE MEDIUM PROPORTION AND YOU CAN COLLECT AND GET FURTHER DETAIL. ABOUT THE DATA IN THOSE CATEGORIES. LET'S TALK ABOUT THE DATA WE HAVE 2016 THROUGH 2018. SO I HAVE A COUPLE OF TABLES HERE. THE FIRST TABLE SHOWS INCLUSION DATA RECORDS FOR NIH DEFINED EXTRAMURAL AND INTRAMURAL CLINICAL RESEARCH. SO THE DATA I WILL SHOW YOU HERE, THEY'RE BASED ON THESE INCLUSION DATA RECORDS. TYPICALLY WE HAVE ONE RECORD PER STUDY BUT YOU CAN HAVE MULTIPLE IN SOME CASES. IN GENERAL THE TOTAL NUMBER OF INCLUSION RECORDS HAS BEEN INCREASING SOMEWHAT SINCE 2016 SO WE HAD 13,000 IN 2016. THAT'S UP TO 16,000 IN 2018. WE ALSO SEE INCREASES IN THE OTHER CATEGORIES WHICH I WILL SHOW YOU HIRE, PROPORTIONAL TO GENERAL INCREASE IN NUMBER OF RECORDS SO THE SECOND COLUMN SHOWS INCLUSION RECORDS WITH ENROLLMENT SO THE DATA ARE BASED ON RECORDS, THEY DON'T HAVE ENROLLMENT DATA WE DON'T HAVE ANY DATA TO REPORT. BUT MOTH ARE ACTUALLY ENROLLING SO YOU WILL SEE DATA FROM THOSE PARTICIPANTS REFLECTED IN THE NEXT SLIDES. MOST INCLUSION DATA RECORDS REFLECT ENROLLMENT AT U.S. SITES. YOU CAN SEE HERE OVER ABOUT 92% RESEARCH IS BASED AT US SITES, AT LEAST 92% OF THE RECORD THAT WE HAVE FOR RESEARCH BASED AT U.S. SITES AND THE OTHER ROUGHLY 8% IS FOR NON-U.S. SITES. IN TERMS OF STUDY ER REFLECTED WE HAD SOME FEMALE ONLY, ABOUT 10% ROUGHLY ACROSS NIH. STUDIES THAT INCLUDE ONLY FEMALES AND ABOUT 5% ARE STUDIES THAT INCLUDE ONLY MALES. THE SECOND TABLE SHOWS SIMILAR DATA BUT THESE ARE FOR NICHD DEFINED PHASE 3 CLINICAL TRIALS ONLY SO IT'S SMALLER NUMBER OF RECORDS YOU SEE HERE SO YOU SEE A SIMILAR TREND IN THE NIH DEFINED PHASE 3 DATA INCREASE IN TOTAL NUMBER OF INCLUSION RECORDS HERE AND ALSO INCREASE IN THE RECORDS WITH ENROLLMENT. ONE DIFFERENCE IS WE TEND TO HAVE A LARGER PROPORTION OF PARTICIPANTS FROM NON-U.S. SITES SO THE U.S. SITE IS 80% ROUGHLY, A RECORDS IN NON-U.S. SITES ABOUT ANOTHER 20% AND WE ALSO HAVE A HIGHER PROPORTION OF FEMALE ONLY INCLUSION RECORDS. VERSUS ALL OF NIH DATA. SO TO LOOK AT THE ACTUAL DIRECTION OF PARTICIPANTS, THE FIRST SLIDE SHOWS YOU CLINICAL RESEARCH BY SEX GENDER FROM PHYSICAL YEAR 2016 TO 2018. THIS IS ALL NIH RESEARCH EXTRAMURAL AND INTRAMURAL. AS YOU CAN SEE ON THIS SLIDE, WE TEND TO HAVE JUST A BUILT -- SLIGHTLY HIGHER PROPORTION OF FEMALES IN OUR CLINICAL RESEARCH STUDIES THAN MALES SO THE FISCAL YEAR 2016 DATA ARE FAIRLY TYPICAL. OF WHAT WE SEE WITH 53% FEMALE PARTICIPANTS AND 45% MALE PARTICIPANTS AND 2% UNKNOWN. IN 2017 WE HAD A BIT OF A BLIP, COUPLE OF STUDIES A LARGE MALE ONLY STUDY, AND ANOTHER STUDY HIGH PERCENTAGE OF MALES WHICH SKEW MORE TOWARDS MALES BUT STILL ROUGHLY 50, 50, 51% MEALS, 41% FEMALE THIS IS YEAR, THE STUDY ENSOD THE DATA RETURNED BACK TO WHAT I WOULD SAY FAIRLY NORMAL 52% FEMALES IN 2018 AND 44% MALES WITH 4% UNKNOWN OR NOT REPORTED. NOW I'LL SHOW YOU DATA FOR DEFINED PHASE 3 CLINICAL TRIALS. WE TEND MORE FEMALE ONLY STUDIES IN OUR NIH DEFINED PHASE 3 CATEGORY THAN OVERALL PORTFOLIO. YOU CAN SEE THAT REFLECTED IN THE DATA HERE. WE HAD 66% FEMALES IN 2016, ABOUT 33% MALES. ABOUT ONE PERCENT UNKNOWN. IN 2017, WE HAD 59% FEMALE PARTICIPANTS, 41% MALE PARTICIPANTS AND NO UNKNOWNS. AND IN 2018, 63% FEMALE PARTICIPANTS, AND 37% MALES AND NO UNKNOWNS. IF WE LOOK AT DISTRIBUTION OF PARTICIPANTS FOR RACE ALL NIH RESEARCH WE SEE IN GENERAL STARTING HERE WITH UNKNOWN OR NOT REPORTED WE HAD A LARGE NUMBER OF UNKNOWNS IN 2016, WE DID SEE A DECREASE FROM 23% IN 2016 TO ALSO THAN 9% IN 2017. BUMPED UP A LITTLE BIT IN 2018 BUT NOT TO THE 2016 LEVEL SO WE SAW ABOUT 12% UNKNOWN. IF WE LOOK AT HERE IN THE GREEN WE CAN SEE MORE THAN ONE RACE, THAT NUMBER IS FAIRLY STEADY, A LITTLE OVER 2% ACROSS THE YEARS. THE PROPORTION OF WHITE PARTICIPANTS, ABOUT HALF OF PARTICIPANTS IDENTIFIED AS WHITE IN 2016, A LITTLE LESS THAN HALF, 47% IN 2017. AND MORE THAN HALF, ABOUT A LITTLE OVER 58% IN 2018 IDENTIFIED AS WHITE. MOVEK TO NATIVE HAWAII OR PACIFIC ISLANDER, LESS THAN 1% SO ABOUT .7% ON 2016, ABOUT .1% IN 2017, ABOUT.2% IN 2018. BLACK AND AFRICAN AMERICAN PARTICIPANTS WE DID SEE AN INCREASE JUST A SLIGHT INCREASE FROM 2016 TO 17 FROM 11% TO 11.6% IN 2017. THEN WE SAW LARGER INCREASE IN 2018 TO 16%. LOOKING AT ASIAN PARTICIPANTS, IN 2016 WE SAW ABOUT 11% IDENTIFIED A Z ASIAN. WE HAD A JUMP IN 2017 DUE TO ONE LARGE STUDY WITH A LARGE NUMBER OF ASIAN PARTICIPANTS, THAT STUDY DROPPED OFF AGAIN IN 2018 AND SO WE -- THE PERCENTAGE OF ASIAN PARTICIPANTS DROPPED BACK DOWN TO 9%. FINALLY AMERICAN INDIAN AND ALASKA NATIVE, IN 2016, WE HAD ABOUT 1.6% OF PARTICIPANTS AMERICAN INDIAN ALASKA NATIVE, WE HAD ONE LARGE STUDY AROUND 1% FOR AMERICAN INDIAN ACHE ACT NATIVE. THAT DROPPED OFF IN 2017 SO THAT NUMBER WEPT DOWN A BIT. TO .7% AND WENT BACK UP TO 1% IN 2018. NOW WE HAVE DATA FOR NIH DEFINED PHASE 3 CLINICAL TRIALS. THESE NUMBERS TEND TO JUMP AROUND A LITTLE BIT MORE THAN OUR OVERALL NIH PORTFOLIO IN PART DUE TO SMALLER NUMBER OF STUDIES AND WE HAVE MORE STUDIES NO T US-BASED STUDIES SO THERE'S COMBINATION OF FACTORS TEND TO BE JUMPING AROUND MORE, WITH UNKNOWN OR NOT IMPORTANT WE HAVE FAIRLY LOW LOW NUMBERS. IN 2016 JUMPED TO 4% IN 2017 ANT 7% IN 2018. THOSE IDENTIFIED AS MORE THAN ONE RACE, FAIRLY SMALL LESS THAN 1% ACROSS THE YEARS. THEN THE NUMBER OF WHITE -- THE NUMBER OF BLACK OR AFRICAN AMERICAN PARTICIPANTS WAS FAIRLY LARGE ABOUT 36% IN 2016. DROPPED TO 15% IN 2017 BACK UP TO 19% IN 2018. THE NUMBER OF ASIAN PARTICIPANTS WAS FAIRLY LARGE, AGAIN, WE DO HAVE SOME VERY LARGE STUDIES WITH ASIAN PARTICIPANTS WHICH WERE INCLUDED IN 2017 AND ANDNDED IN 2018, WE SAW 47% IN 2016, THAT DROPPED IN 2017 AND DOWN TO 4.5% IN 2018. FINALLY AMERICAN INDIAN ALASKA NATIVE, DID NOT REGISTER IN 2016.3% IN 2016 AND.7 IN 2018. IT WAS SMALL, 6.6% IN 2016 AND JUSTIFIED 15% IN 2017. 65% IN 2018. SO AS YOU SEE PHASE 3 DATA THE DATA TEND TO JUMP AROUND QUITE A BIT MORE DEPENDING ON EXACT NATURE OF THE STUDIES FUNDING AND HOW LARGE THEY ARE. AND THEN FINALLY I WANTED TO TALK ABOUT OUR DATA ON NIH ENROLLMENT IN CLINICAL RESEARCH BY ETHNICITY. IN 2016 ABOUT 68% OF PARTICIPANTS IDENTIFIED NOT HISPANIC. ABOUT 12% IDENTIFIED HISPANIC AND ABOUT 20% UNKNOWN SO WE HAD A FAIRLY LARGE NUMBER OF PARTICIPANTS WHO IDENTIFIED AS YOU CAN KNOWN ETHNICITY THAT YEAR. IN 2017 WE SAW DECREASE IN UNKNOWNS TO 9% AND 84% IDENTIFIED AS NOT HISPANIC, 7% IDENTIFIED AS HISPANIC OR LATINO. IN FISCAL YEAR 2018 THE UNKNOWNS JUMPED UP A LITTLE BIT TO 13% AND ABOUT 78% OF PARTICIPANTS IDENTIFIED AS NOT HISPANIC, ABOUT 9% IDENTIFIED HISPANIC. I SAW FAIRLY SIMILAR TREND IN ENROLLMENT FOR NIH DEFINED PHASE 3 CLINICAL TRIALS REGARDS TOETH IN MISTY AND WE HAD A SMALLER NUMBER OF UNKNOWN WHICH IS IS TYPICAL. BUT WE HAD ABOUT 91% OF PARTICIPANTS IDENTIFY NOT HISPANIC AND NINE PERCENT IDENTIFY HISPANIC IN 2016. IN 2017 ABOUT 87 PARTICIPANTS IDENTIFY IS NOT HISPANIC, 6% IDENTIFY AS HISPANIC, SOME PERCENT OF UNKNOWNS THAT YEAR. WE SAW DECREASE IN UNKNOWNS IN 2018 TO 3%, ABOUT 85% OF PARTICIPANTS IDENTIFY HISPANIC AND 12% IDENTIFY AS HISPANIC. SO I KNOW THAT'S A LOT OF DATA TO DIGEST BUT OVERALL HOPEFULLY GIVES YOU SOMEWHAT AN UNDERSTANDING WHAT PARTICIPATION IN OUR RESEARCH LOOKS LIKE. WITH THAT I'LL SHIFT GEARS A BIT THE TALK ABOUT THE COMMON RULE. WEARING MY HUMAN SUBJECTS HAT HOPEFULLY MANY ARE ABARE THE COMMON RULE -- AWARE THE COMMON RULE WAS REVISED BUT I WANT THE MAKE SURE YOU ALL UNDERSTAND WHAT I'M TALKING ABOUT WHEN I TALK ABOUT THE COMMON RULE, THE COMMON RULE I'M TALKING ABOUT THE HHS REGULATIONS ON HUMAN RESEARCH PROTECTIONS. 45 CFR PART 46. THERE ARE SEVERAL SUBPARTS TO COMMON RULE INCLUDING SUBPART A B C D AND E. BUT WHEN I TALK ABOUT -- WHEN I REFER TO COMMON RULE I'M TALKING SUBPART A. WHICH IS WHERE WE SEE MOST CHANGES THOUGH THERE ARE OTHER PARTS OF 45 CFR PART 46 THAT RELATE TO POPULATIONS, WITH ADDITIONAL PROTECTIONS AND IRB REGISTRATION WE ARE FOCUSING ON SUBPART A. SO JUST TO GIVE YOU A LITTLE TIME LINE OF THE CHANGES, THE COMMON RULE FIRST PUBLISHED IN FEDERAL REGISTER BACK IN 2017, JANUARY OF 2017. THE IMPLEMENTATION WAS DELAYED AD FEW TIMES, SO THE IMPLEMENTATION DATE WAS IN JULY OF 2018. BUT FOR THAT DATE, AT THAT DATE THE IMPLEMENTATION WAS VOLUNTARY AND INSTITUTIONS COULD TAKE ADVANTAGE OF ONLY 3 BURDEN REDUCING PROVISIONS IN THE COMMON RULE. THE COMPLIANCE DATE EVERYONE HAD TO COMPRESS TO COMPLY WAS THIS JANUARY, JANUARY 21st, 2019 AS OF THAT DATE INSTITUTIONS ARE EXPECTED TO COMPLY WITH ALL PROVISIONS OF THE REVISED COMMON RULE SAVE ONE PROVISION ON USE OF A SINGLE IRB. I PUT AN ASTERISK THERE BECAUSE NIH DOES HAVE A POLICY ON USE OF SINGLE IRB IN EFFECT SINCE JANUARY OF 2018. SO ALTHOUGH THIS IS NOT A PROVISION OF COMMON RULE THAT'S INSTITUTION VERSUS TO COMPLY WITH AT THIS TIME, NIH EXPECTS COMPLIANCE WITH SINGLE IRB POLICY FOR APPLICATIONS FOR DUE DATES JANUARY 25, 2018 OR LATER. SO JUST OR GENT YOU TO THE PROVISIONS OF THE REVISED COMMON RULE, THERE WERE A NUMBER OF CHANGES INCLUDING CHANGES TO INFORMED CONSENT, WHICH INCLUDES CHANGES TO REQUIREMENTS FOR INFORMED CONSENT FORMS, A BROAD CONSENT OPTION FOR SECONDARY RESEARCH, ELIMINATING REQUIREMENT TO WAVE CONSENT FOR SCREENING RECRUITMENT ACTIVITIES. ALSO CHANGES TO IRB REVIEW. INCLUDE REMOVING THE REQUIREMENT FOR IRB FOR GRANT APPLICATIONS REQUIRE USE OF SINGLE IRB AND CHANGES TO REQUIREMENTS FOR CONTINUING REVIEW. AND UPDATES TO EXPEDITED REVIEW. FINALLY CHANGES TO DEFINITION THESE WERE GENERALLY CLARIFICATION RATHER THAN FUNCTIONAL CHANGES BUT WE DID HAVE SOME CHANGES TO TERMS INCLUDING HUMAN SUBJECTS AND RESEARCH. AND WE SAW EXPANSION OF CATEGORIES OF EXEMPT RESEARCH. AS MENTIONED THERE'S A LOT IN HERE, IF YOU WANT SPECIFICS ABOUT THESE PROVISIONS I ENCOURAGE YOU TO VISIT THE OHRP WEBSITE ON COMMON RULE WITH FAQs AND RESOURCES AND VIDEOS WHICH ARE VERY HELPFUL BUT TODAY I WILL FOCUS ON THOSE PARTS OF THE COMMON RULE THAT AFFECT THE WAY NIH DOES BUSINESS. SO IN TERMS OF NIH IMPLEMENTATION OF THE COMMON RULE, THERE ARE FEW PIECES THAT CHANGE PROCEDURES HERE AT NIH. THE FIRST IS, IS THAT THERE IS NO LONGER AN NIH REQUIREMENT FOR IRB TO REVIEW GRANT APPLICATIONS IN CONTRACT PROPOSALS. SO IF YOUR STUDY FALL UNDER REVISED COMMON RULE THE IRB DOES NOT NEED TO REVIEW THE GRANT APPLICATION AND CONTRACT PROPOSAL IN ADDITION TO THE RESEARCH PROTOCOL IF NOT REQUIRED BY YOUR INSTITUTION OR OTHERWISE REQUIRED. THIS IS NEW, PREVIOUSLY IRB DID HAVE TO REVIEW THESE AND WE HEARD THAT THEY WOULD RATHER NOT. SO WE REMOVED THOSE THAT ARE LAUGHING MUST HAVE IRB EXPERIENCE. SO GOOD NEWS IS NIH NO LONGER REQUIRES THAT YOU DO SO, IF NOT REQUIRED UNDER FORMER COMMON RULE THE IRB DO NOT HAVE TO REVIEW IT. AND ANOTHER PIECE OF THE COMMON RULE IS POSTING OF CLINICAL TRIAL CONSENT FORMS SO THE COMMON RULE INCLUDES PROVISION FOR POSTING OF CLINICAL TRIAL CONCEPT FORMS WE WILL TALK ABOUT A BIT MORE AND GIVE YOU DETAILS ON THAT. BUT NIH HAS DEVELOPED A WEBSITE WITH INSTRUCTIONS FOR POSTING THOSE FORMS. AND THEN FINALLY WE HAVE NO LONGER HAVE AN NIH REQUIREMENT FOR CERTAIN CONTINUING REVIEWS. AS I MENTION THE REVISED COMMON RULE INCLUDED CHANGES TO REQUIREMENTS FOR CONTINUING REVIEW. AND NIH PREVIOUSLY HAD A REQUIREMENT THAT EVERY STUDY HAD TO GO THROUGH ANNUAL REVIEW. NOW IF YOU ARE UNDER REVISED COMMON RULE AND NOT OTHERWISE REQUIRED, TO HAVE CONTINUING REVIEW AND COMMON RULE OR INSTITUTION NIH WILL NOT REQUIRE THAT STUDY UNDERGOES CONTINUE REVIEW UNLESS SPECIFIED IN THE FUNDING OPPORTUNITY ANNOUNCEMENT. SO THIS INCLUDES STUDIES ELIGIBLE FOR EXPEDITED REVIEW AND STUDIES THAT COMPLETED INTERVENTION AS MENTION IN THE COMMON RULE. IN ADDITION IT INCLUDES CHANGES TO -- UPDATING OUR FORMS OUR INSTRUCTIONS STALLS AND GUIDANCE TO -- TOOLS GUIDANCE TO MAKE SURE THIS IS ALIGNED WITH THE EXEMPTIONS. USING SINGLE IRB REVIEW WHICH I WILL TALK ABOUT A BIT MORE. SO WE PUT OUT A GUIDE NOTICE BACK IN JANUARY ANNOUNCING JUST THOSE THINGS THAT I MENTION TODAY ABOUT THE CHANGES TO NIH REQUIREMENTS AS A RESULT OF THE REVISED COMMON RULE. WE PROVIDED SOME ADDITIONAL CLARIFICATION ON SOME OF THOSE PROVISIONS, INCLUDING REMOVAL REQUIREMENT FOR THE IRB TO REVIEW THE APPLICATION OR PROPOSAL. SO THE NOTICE WENT OUT IN JANUARY, STATED THAT AS OF JANUARY 21st, 2019 NIH WOULD NO LONGER REQUIRE IRB REVIEW OF THE ENTIRE GRANT APPLICATION FOR CONTRACT PROPOSAL. I DO SOMETIMES GET QUESTIONS DOES NIH REQUIRE IRB APPROVAL? YES, WE REQUIRE IRB APPROVAL THAT HASN'T CHANGED JUST THAT THE IRB DOESN'T HAVE TO REVIEW BOTH GRANT APPLICATION AND RESEARCH APPLICATION -- RESEARCH PROTOCOL. I ALSO MENTIONED NO CHANGES TO EXEMPTIONS AS A RESULT OF REVISED COMMON RULE HERE IS A TOOL WE DEVELOPED TO HELP YOU UNDERSTAND THOSE CHANGES WHICH IS AVAILABLE ON OUR WEBSITE WHICH IS INCLUDED ON ONE OF MY SLIDES. WE USE TO HAVE SIX CATEGORIES OF EXEMPT RESEARCH, WE NOW HAVE EIGHT, WE HAVE THREE NEW EXEMPTION, MATH DOESN'T WORK THERE, WHY? EXEMPTION 3 IS REPLACED. NOW IT'S RESEARCH USING BENIGN BEHAVIORAL INTERVENTIONS IN ADULTS. THAT'S NEW EXEMPTION, THE OTHER NEW EXEMPTIONS INCLUDE EXEMPTION 7 OR 8 WHICH RELATE TO STORAGE OF IDENTIFIABLE INFORMATION OF BIOSPECIMENS WITH BROAD CONSENT. EXEMPTION 8 INCLUDES ACTUAL RESEARCH BEING DONE WITH THAT INFORMATION OR BIOSPECIMENS. BOTH OF THOSE REQUIRE LIMITED IRB REVIEW. SOME OF THE EXEMPTIONS WERE EXPANDED INCLUDING TWO, IN SOME CASES NOW DATA IDENTIFIABLE WITH LIMITED IRB REVIEW. EXEMPTION FOUR INCLUDED SOME ADDITIONAL PROVISIONS FOR DATA PROTECTED BY HIPAA FOR EXAMPLE. SO I ENCOURAGE YOU THE LOOK AT THIS TOOLS THAT ARE AVAILABLE TO HELP YOU UNDERSTAND CHANGES TO THE EXEMPTIONS AND WE ARE DOING OUR BEST TO MAKE SURE INVESTIGATORS UNDERSTAND WHEN APPLYING TO NIH FOR NIH RESEARCH WHICH CATEGORY THEIR APPLICATION MAY FALL UNDER. FINALLY I WANT TO REVISIT USE OF SINGLE IRB AS I MENTION THE REVISED COMMON RULE REQUIRE USE OF SINGLE IRB AS OF JANUARY 20TH, 2020. HOWEVER OUR NIH POLICY IS ALREADY IN EFFECT FOR DOMESTIC MULTI-SITE STUDIES. WE PUBLISHED IN THE NIH GUIDE AND FEDERAL REGISTER JUNE 21, 2016, IT WAS DELAYED A BIT BUT IT BECAME EFFECTIVE FOR COMPETING GRANT APPLICATIONS, SUBMITTED DUE DATES ON OR AFTER JANUARY 25, 2018 OUR SOLICITATIONS ON OR AFTER JANUARY 25, 2018. AS OF THAT DATE APPLICATIONS THAT COME IN ARE EXPECTED TO INCLUDE A PLAN FOR USE OF A SINGLE IRB. IN GENERAL FOR MULTI-SITE DOMESTIC STUDIES WERE EXPECT TO USE A SINGLE IRB UNLESS AN EXCEPTION APPLIES. THAT WAS ALL I HAD FOR TODAY. I DID INCLUDE OUR WEBSITE FOR MORE INFORMATION PANT ANY OF THESE TOPICS. AND YOU ARE ALL FREE TO EMAIL ME AT THE MAILBOX INCLUSION AT MAIL.NIH.GOV IF YOU HAVE ANY QUESTIONS. [APPLAUSE] >> DR. STEINER, DR. GREGORY. >> I HAVE A SIMPLE QUESTION, I THINK SLIDES WOULD BE INC ABLY HELPFUL (INAUDIBLE) I HAVE THEM HERE BE SENT TO US? LIKE THE TIME LINE FOR INCLUSION. >> I HAVE NO PROBLEM ASSURING MY SLIDES, I WILL SAY THE ONE CAVEAT TO THAT IS DATA BY RCDC CATEGORY INCLUDES A LINK WHICH WHILE PUBLICLY AVAILABLE NOT YET FORMALLY ANNOUNCE SOD THIS IS THE SLIDE HERE. I WOULD PREFER THIS NOT BE BROADLY DISTRIBUTED UNTIL WE ANNOUNCE IT WHICH WOULD BE FAIRLY SOON. ANYTHING ELSE, YES. (OFF MIC) >> HAPPY TO SHARE THAT. >> THANK YOU. I GUESS SINGLE IRB AS PI, I WOULD JUST HE CAN STATIC ABOUT. AS PI DOING MULTI-SITE STUFF BECAUSE NIH SAYS IT DOESN'T MEAN EACH INDIVIDUAL HOSPITAL OR DIFFERENT SITES WON'T STILL WANT THEIR OWN IRB. ARE THERE ANY THOUGHTS ABOUT WORKING THAT AROUND? >> WE DO HAVE A WEBSITE NCATS DEVELOPED THIS SMART IRB HOT FORM AND A WEB SO IT WHICH TALKS ABOUT THIS, GIVES EXAMPLES OF RELIANCE AGREEMENTS, IT REALLY IS A CULTURE CHANGE, USE OF SINGLE IRB ACROSS INSTITUTIONS SO WE HAVE SEEN SUCCESS WHAT WE FOUND IS ONCE IT DOES TAKE A LITTLE BIT MORE TIME IN THE BEGINNING WHEN YOU HAVEN'T DONE THIS BEFORE TO SET UP RELIANCE AGREEMENTS AND GET PEOPLE ON BOARD. BUT ONCE THAT'S DONE THEE IN TIME SHOULD BE EASIER. THERE'S TIME SAVE AND PROTOCOL AMENDMENTS DOWN THE ROAD. >> ARE YOU PENALIZED WORKING WITH HOSPITAL X AND HOSPITAL X SORRY I ALWAYS GET IRB IS THE IRS PENALIZED WITH TWO IRBs OR HOW DO YOU HANDLE THAT? >> IF APPROXIMATE BUTCATIONS WAS SUBMITTED AFTER JANUARY 25, 2018, THAT'S CONSIDERED NON-COMPLIANT UNLESS AN EXCEPTION WERE GRANTED SO I ENCOURAGE YOU TO TALK TO YOUR PROGRAM OFFICER IN THAT SITUATION. >> SOME INCITE INTO WHY YOU'RE STILL COLLECTING DATA OF SUBJECTS THAT ARE NOT IDENTIFY BY BIOLOGICAL SEX YET BUT UNKNOWN THEN FOLLOW-UP QUESTION, MIGHT BE MORE FOR DR. (INAUDIBLE) SHE WROTE EDITORIAL ON THIS, DO YOU THINK YOU'RE COLLECTING BIOLOGICAL SEX AND CURRENT GENDER IDENTITY IN THE FEAR FUTURE? >> THE WAY WE CURRENTLY COLLECT IT? >> FOR ANY DATA THAT ARE COLLECTED, THE INFORMATION THAT IS COLLECTED IS VOLUNTARY. IT'S ALWAYS UP TO THE PARTICIPANT IF THEY WISH TO DISCLOSE THAT INFORMATION. AND IF THEY DON'T THEY ARE INCLUDED IN THE UNKNOWN OR NOT RECORDED CATEGORY. HOW WE COLLECT SEX OR GENDER, AT THIS POINT WE LEAVE IT UP TO THE INVESTIGATOR WHICH ONE TO COLLECT. THEY CAN COLLECT EITHER SEX AT BIRTH, COLLECT CURRENT GENDER IDENTITY, REALLY DEPENDS ON NATURE OF THE RESEARCH. WHAT'S IMPORTANT TO THAT QUESTION. CHECK ONE OR THE OTHER BUT YOU HAVE TO COLLECT ONE OF THEM AND IT HAS TO BE UP TO THEM IF THERE ARE MORE WOMEN INCLUDED IN THE STUDY. EFFORTS TO COLLECT GENDER IDENTITY BECAUSE THEY'RE NUANCED AN COMPLICATED THAN SEX, SEX IS QUITE COMPLICATED, WE SEE THAT THERE'S A METHOD LOGIC BARRIERS MOVEK FORWARD WITHOUT HAVING SOLID VALIDATED INSTRUMENTS AND TOOLS THAT ARE HIGHLY RELEVANT IN THE CONTEXT THAT NIH RESEARCH OPERATES. WE ARE EXCITE AS PART OF OUR TRANS-NIH STRATEGIC PLAN TO HAVE A SPECIFIC GOAL FOCUSED ON METHODS, AND UNDER THAT GOAL WOULD BE EFFORTS TO MEASURE ASSESS GENDER SO THAT'S A REAL SPACE WE CAN ALSO WORK WITH SEXUAL GENDER MINORITY RESEARCH OFFICE STMRO HERE AND NIH AND DPKPSI BUT THERE'S REAL BARRIERS TO THAT, THOUGH THAT CONVERSATION NEEDS TO GO FORWARD AS DAWN SAID WE TRY NOT TO BE PRESCRIPTIVE, WHAT'S RELEVANT TO THE INVESTIGATOR AND THE STUDY AND THE CONDITION AND THE ISSUE. THEN I THINK DR. -- HAD A QUESTION AS WELL? >> THE COMMON RULE IS TRYING TO HELP INVESTIGATORS USE LARGE DATA SETS, THERE ARE A NUMBER OF LARGE DATA SETS THAT WERE SAVED AND STORED BEFORE THIS LOOSER COMMON RULE, WHO WILL BE THE ARBITRATEOR OF WHETHER OR NOT THOSE SAMPLES IN THOSE PHENOTYPES CAN BE USED ESPECIALLY NIH SPONSORED NHLBI RESEARCH. RELATED TO KIM'S QUESTION, THERE'S LOCAL IRBs THAT ARE GOING TO HAVE A REAL PROBLEM WITH THIS. >> SO TRYING TO OBTAIN BROAD CONSENT RETROACTIVELY IS A CHALLENGE, I'M -- I'M AFRAID I'M PROBABLE -- (OFF MIC) >> RIGHT. I CAN SAY AS FAR AS NIH IS CONCERNED ONLY THAT IF YOU ARE UNABLE TO OBTAIN BROAD CONTENT IT WOULDN'T BE -- THAT APPLICATION WOULDN'T BE ELIGIBLE FOR EXEMPTION SO FROM OUR PERSPECTIVE IT WOULD BE SUBJECT TO THE SAME REGULATIONS OTHER HUMAN SUBJECTS RESEARCH IS SUBJECT TO THEY WOULD HAVE TO HAVE IRB APPROVAL, WE EXPECT THEM TO FOLLOW ALL THE OTHER POLICIES RELATED TO HUMAN SUBJECTS RESEARCH. IN TERMS OF THE CHALLENGES OF IMPLEMENTATION SOME I HAVE TO REFER TO MY COLLEAGUES AT OHRP, WE HAVE NOT YET SEEN GUIDANCE FOR EXEMPTIONS 7 OR 8, WE ARE LOOKING FORWARD TO MORE GUIDANCE FROM THEM WHICH WILL HELP ADDRESS SOME OF THESE CHALLENGES. >> DIFFERENT QUESTIONS. IN YOUR PIE CHART BACK TO REPRESENTATION OF WOMEN AND MEN OVER 2016, 17, 18, IF YOU TAKE OUT THE REPRODUCTIVE HEALTH WOMEN'S REPRODUCTIVE HEALTH NICHD WHAT HAPPENS AND ARE THOSE DATA AVAILABLE? >> WE CERTAINLY DO HAVE DATA AVAILABLE. >> COMMON DISEASE STUDIES THAT ARE NOT REPRODUCTIVE IN NATURE. THERE'S MORE NICHD THAN THERE IS UROLOGY. SO IT'S NOT A BALANCE. >> WE CERTAINLY HAVE DATA AVAILABLE ON SINGLE SEX STUDIES HAPPY TO SHARE WITH YOU. THEY DO LOOK FAIRLY SIMILAR. IN TERMS OF TAKING OUT STUDIES ON REPRODUCTIVE HEALTH, WE DON'T HAVE AN EXACTLY THAT WAY. WE HAVE THE WEBSITE WHICH I MENTION TO YOU WHICH DOES INCLUDE A CATEGORY FOR REPRODUCTIVE HEALTH SO YOU CAN SEE HOW MANY STUDIES ARE IN THAT CATEGORY. YOU CAN EXCLUDE ON THAT WEBSITE ALSO MALE ONLY FEMALE ONLY SO YOU CAN LOOK AT IT MORE GRANULAR THERE. DON'T HAVE THOSE DATA FOR YOU TODAY. >> LAST QUESTIONS BEFORE DAWN BEFORE SHE LEAVES? THANK YOU VERY MUCH. APPRECIATE IT. [APPLAUSE] SO NEXT UP IS DR. SHARON HUNTER OWH'S BASIC TRANSLATIONAL RESEARCH AND SHE WILL BE PROVIDING AN UPDATE ON THE SAPV PROGRAM SEX AS BIOLOGICAL VARIABLE PROGRAM TODAY. DR. HUNTER. >> GOOD AFTERNOON. WE HAVE HAD A VERY FULL AGENDA TODAY. SO I APPRECIATE YOU HANGING WITH ME THIS LAST TOPIC. AND WANT TO THANK YOU FOR THE OPPORTUNITY TO PROVIDE A PROGRAM UPDATE. ON SEX AS A BIOLOGICAL VARIABLE. SO TALK NOT ONLY ABOUT THE SABV POLICY BUT THE RELATED RESEARCH PROGRAMS AS WELL AS IMPORTANTLY, SABV RELATED TO THE SCIENCE. SO HERE IS OUR AGENDA FOR TODAY. OUR OUTLINE. WHICH IS PROBABLY NO SURPRISE SITTING HERE BUT SABV POLICY UPTAKE IN ADOPTION IS NOT COMPLETE. AFTERTHAT WE WILL TALK ABOUT NEW IMPETUS FOR ASSESSMENT OF SABV POLICY UPTAKE, PARTNERSHIPS FOR SABV RESOURCE DEVELOPMENT, AND OTHER SABV RESOURCES. FINALLY, THE SABV APPLICATION TO THE SCIENCE. BUT FIRST LET US TALK A LITTLE BIT ABOUT THE SABV POLICY. YOU MIGHT BE FAMILIAR WITH THIS BUT THE SABV POLICY IN A NUTSHELL, NOTICE OD-15-102 STATES THAT THE -- THE TITLE IS CONSIDERATION OF SEX AS A BIOLOGICAL VARIABLE IN NIH FUNDED RESEARCH. THE POLICY STATES IN A NUTSHELL THAT NIH EXPECTS THAT SEX AS A BIOLOGICAL VARIABLE WILL BE FACTORED INTO RESEARCH DESIGN, ANALYSES AND REPORTING IN VERTEBRATE ANIMAL AND HUMAN STUDIES. YOU SEE THIS POLICY TOOK EFFECT IN JANUARY OF 2016 SO WE'RE THREE YEARS INTO THE POLICY. SO WHAT I WOULD LIKE TO DO NOW IS TO HIGHLIGHT TWO EXAMPLES THAT SHOW THAT THE SAPV POLICY UPTAKE IN ADOPTION IS NOT COMPLETE. SO THIS FIRST EXAMPLE COMES TO US PRE-CLINICAL RESEARCH, IT SHOWS FIRST THE LITERATURE IS RIPE WITH EXAMPLES OF SEX BIAS, FAVORING ONE SIX OR ANOTHER AND SEX OMISSION, THE LACK OF REPORTING ONE SEX. VIRTUALLY NEUROSCIENCE RESEARCH HAS THE DUBIOUS ON NOR OF HAVING A LOOK HISTORY OF BOTH SEX BIAS AND SEX OMISSION. IN THIS 2017 ARTICLE BY WILLS AND COLLEAGUES, THEY SHOW SLOW PROGRESS ON RESULTS REPORTING FOR PRE-CLINICAL RESEARCH. THE OFFICE REVIEW THE SEX OF RODENTS IN OVER 6,000 NEUROSITES PAPERS PAPERS IN NEUROSCIENCE RESEARCH. THEY SEE THAT LOOKING AT THE RESULTS HERE, LOOKING AT 2014 COMPARED TO 2010, SEX OMISSION WHICH IS HERE IN ORANGE IS DECLINING. BUT SEX BIAS, SEE IF I CAN USE MY POINTER. BUT SEX BIAS. HERE IN GREEN AND BLUE REMAINS PRESENT WITHIN 2014 INCREASING NUMBERS OF ARTICLES REPORTING THE SOLE USE OF MALES. SO THAT'S PRE-CLINICAL RESEARCH. I NOW TURN TO INCOMPLETE UPTAKE IN NIH STUDY SECTIONS. THE SECOND EXAMPLE IS ARTICLE PUBLISHED AD FEW MONTHS AGO, VOLUME 28 OF THE JOURNAL OF WOMEN'S HEALTH, THE OFFICE OF DR. WOODRUFF, STUDY SABV POLICY IMPLEMENTATION AS VIEWED FROM THE PERSPECTIVE OF NIH STUDY SECTION MEMBERS AND JUST TO RECAP AS YOU KNOW NIH STUDY SECTION MEMBERS ARE CHARGED WITH REVIEWING APPLICATIONS FOR THE CONSIDERATION OF SABV. AND ARE INSTRUCTED TO DOWNGRADE THE SCORE IN THE APPLICATION IF SABV IS NOT APPROPRIATELY ADDRESSED. I WILL SAY HERE THIS ARTICLE IS THE FIRST EVER PEER REVIEWED REPORT WHEN REVIEW IS AD ATTITUDES AND OPINIONS ON S ABV OPINION AND PEER REVIEW. A LITTLE BIT ABOUT THE STUDY, THE OFFICE SENT HERB MAILS TO 40,000 STUDY MEMBERS WHO SERVED ON STUDY SECTIONS IN 2016 AND 5,000 STUDY SECTION MEMBERS WHO SERVED ON STUDY SECS IN 2017. THEY -- SECTIONS IN 2017. THEY SURVEYED THE INDIVIDUALS AND THE RESPONSE RATE WAS 10% FOR 2016, AND 15% IN 2017. WE MIGHT TALK ABOUT THAT. THE SURVEY QUESTIONS INCLUDED SOME DEMOGRAPHICS ABOUT THE INDIVIDUALS. THEIR EXPERIENCE AS STUDY SECTION MEMBER WHETHER THEY WERE NEWER OR SEASONED STUDY SECTION MEMBERS AND PRIOR EXPERIENCE SUBSPACE RESEARCH OR RESEARCH ON SEX DIFFERENCES. FROM ALSO IMPORTANTLY THEY SURVEY THEIR OPINIONS AND ATTITUDES TO THE IMPLEMENTATION AND EVALUATION OF THE NIH SABV POLICY AS IT RELATES TO SCORING. TURVY INCLUDED OPEN ENDED QUESTIONS AND ALLOWED THEM TO MAKE SOME COMMENTS. THE STUDY HAD NUMBER OF POSITIVES, FIRST THE SABV POLICY IS ACCEPTED AND UNDERSTOOD BY MAJORITY OF REVIEWERS, THEY THOUGHT THEY UNDERSTAND THE POLICY AND THE POLICY IS IMPORTANT. SECONDLY MOST OF THE STUDY SECTION MEMBERS SURVEY BELIEVE THE SABV POLICY IS IMPROVING RIGOR AND REPRODUCIBILITY. THEY SEE AN INCREASE IN THE CONSIDERATION OF SABV IN GRANT APPLICATIONS AND AMONG STUDY SECTIONS. SO I WOULD LIKE TO TALK A LITTLE BIT ABOUT THE DATA IN DETAIL. THIS IS ADAPTED FROM THE PUBLICTION. AS WE SEE HERE, A KEY FINDING IS THAT FROM 2016 TO 2017, SURVEY NIH STUDY SECTION MEMBERS RECEIVED INCREASE IN ACCORDANCE OF S -- CONSIDERATION OF SABV BY APPLICANTS, THIS IS GOOD NEWS. IT IS EVIDENT BY LOOKING AT THE DATA. FOR QUESTION ONE APPLICANTS ADEQUATELY ADDRESS THE INCORPORATION OF SABV INTO THE EXPERIMENT DESIGN AND ANALYSES AND REPORTING. IN 2016 THIS IS HOW WE READ THESE -- IT'S COMPLICATED BUT IN 2016 WE SEE THAT HALF OF THE REVIEWERS FELT THAT MOST OF THE APPLICANTS THAT'S IN GREEN ADDRESS SABV. IN 2017 TWO-THIRDS OF THE STUDY SECTION MEMBERS SURVEYED FELT THAT MOST, THAT'S IN GREEN ADDRESSED SABV. IN THEIR APPLICATIONS. FOR QUESTION TWO WE SEE A SIMILAR TREND, THE STUDY SECTION MEMBERS IN 2016, 61% FELT THAT THE MAJORITY OF STUDY SECTION MEMBERS ADDRESSED ACCOUNT FOR SABV. THAT GOES UP TO 71% IN 2017. NOT ABOUT THE HALF GLASS FULL BUT WHAT I WILL LICK TO HIGHLIGHT HERE IS THAT LOOK AT ANOTHER WAY, FOR BOTH OF THESE QUESTIONS IT'S ALSO CLEAR 30% REVIEWERS FELT THAT LESS THAN HALF OF THE APPLICATIONS ADEQUATELY CONSIDERED SABV. SO LET'S LOOK AT THIS A LITTLE CLOSELY. THIS IS FOCUS ON 2017. HERE IN 2017 HIGHLIGHT HERE IN RED IS THAT A THIRD OF THE STUDY SECTION MEMBERS REVIEWED SURVEY FELT THAT HALF OF THE -- HALF OR FEWER OF THE APPLICANTS ADEQUATELY ADDRESS SABV. LET'S LOOK AT QUESTION TWO, AGAIN. 30% OF THOSE SURVEYED FELT THAT FEWER THAN HALF OF THE APPLICANTS CONSIDERED SABV IN RESEARCH STRATEGY. SO I ENCOURAGE YOU TO REVIEW THIS APPLICATION IN DETAIL, HAS A LOT OF DATA, TALKS SEX DIFFERENCES IN TERMS OF STUDY SECTION MEMBERS WHICH IS INTERESTING. I SAY THIS STUDY DOES HAVE LIMITATION BUT OVERALL HOWEVER IT IS CLEAR THERE IS INCOMPLETE UPTAKE ADOPTION AND IMPLEMENTATION OF SABV POLICY IN NIH BUSINESS PRACTICE ACCORDING TO THE OPINION OF STUDY SECTION MEMBERS. THESE TWO EXAMPLES ONE FROM PRE-CLINICAL RESEARCH AND THIS ONE HERE, FROM EXAMINATION OF NIH BUSINESS PRACTICES DO INDICATE LIMITED UPTAKE OF SABV SO WE NEED MORE STUDIES MORE EVALUATIONS HELP INFORM FUTURE ACTION TO INCREASE SABV POLICY UPTAKE. SO NEXT I WOULD LIKE TO TURN TO A NEW IMPETUS FOR ASSESSMENT OF SAPV POLICY UPTAKE. ONE MILLION ASSESS. SABV POLICY UPTAKE. FIRST AND FOREMOST BECAUSE THE CONSIDERATION SABV AS WE KNOW ENHANCE THE HEALTH OF WOMEN AND MEN. REASON NUMBER TWO, CONGRESS ASKED US TO. WE HAVE HEARD LOT OF CONVERSATION ABOUT 21st SENTLY CURES BUT THE 21st CENTURY CURES ACT OF 2016 CHARGED THE NIH THROUGH THE ADVISORY COMMITTEE OF THE NIH DIRECT TO UPDATE POLICY OF RIGOR AN REPRODUCIBILITY AND CONSIDERATION OF SEX IN PRE-CLINICAL RESEARCH AS APPROPRIATE. SO WITH THIS MANDATE THE ADVISORY COMMITTEE TO THE NIH DIRECTOR HAS WORKED WITH THE COMMITTEE TO ASSESS POSSIBLE UPDATES TO RIGOR AND REPRODUCIBILITY. FOR SABV, WE HAVE THE TRANS-NIH SABV WORKING GROUP AND WE HAVE BEEN WORKING TO ASSESS POSSIBLE UPDATES ON SABV. SO A LITTLE BIT ABOUT THE TRANS-NIH WORKING GROUP. IT WAS -- THE TRANS-NIH SABV WORKING GROUP WAS ESTABLISHED IN MANY SEPTEMBER OF 2014 WITH MANDATE TO INFORM SABV POLICY DEVELOPMENT AND CHAIR IS OUR OWN DIRECTOR, DR. JANE JANINE CLAYTON AND MEMBERS ARE SENIOR IC STAFF NOMINATED FOR IC OR OFFICE DIRECTOR. WE MEET QUARTERLY AND THE ORWH -- DR. WIGGINS AND GORDESKI WHO SERVES AS EXECUTIVE SECRETARY FOR THAT MEETING. THESE ARE THE MEMBERS, QUITE A FEW MEMBERS NOTE THAT ALMOST EVERY INSTITUTE AND CENTER AS APPOINTED REPRESENTATIVES TO THE WORKING GROUP AND IN FACT SOME ICs HAVE MORE THAN ONE REPRESENTATIVE. THE WORKING GROUP ALSO NOT ONLY HAS TWO STANDARDS COMMITTEES, ONE FOCUSED ON RESEARCH SCIENTIFIC PROGRAMS AND ISSUES AND THE OTHER FOCUSED ON PEER REVIEW. HERE ARE TO TURN BACK TO THE RECOMMENDATIONS OF THE 21ST CENTURY CURES ACT REGARDING RIGOR AND REPRODUCIBILITY THESE ARE NOT ONLY FOUR RECOMMENDATIONS THEY HAVE COME UP WITH, REGARDING SABV, WE HAVE BEEN FOCUSED ON RESOURCE NOT RIGOR BUT SABV ALSO ARE INTERESTED IN NUMBER FIVE OUTCOMES EVALUATION. SO I WANT TO TALK A LITTLE BIT ABOUT THE ROLE OUTCOMES EVALUATION CAN PLAY IN THE EVALUATION OF SABV AND TO DO THAT I WOULD FIRST LIKE TO HIGHLIGHT A NEW PUBLIC LAW THAT CAN BE OUR GUIDE FOR OUTCOMES EVALUATION ON SABV. SO THIS IS PUBLIC NOW, 115-135 ENACTED BY 115th CONGRESS SIGNED INTO LAW JUST A FEW MONTHS AGO. THE BILL YOU SEE HERE HR 40174 OF INTEREST IS ENTITLED FOUNDATIONS OF EVIDENCE BASED POLICY MAKING ACTION OF 2018. BRIEFLY THE IMPORTANCE OF THIS BILL IS IT IMPROVES EVIDENCE BASED POLICY THROUGH STRENGTHENING FEDERAL AGENCY EVALUATION CAPACITY. THIS BILL PROVIDES A IMPETUS FOR EVALUATION ACROSS THE ENTIRE FEDERAL GOVERNMENT INCLUDING THE NIH. IN RESPONSE TO NEW BILL NIH CREATED OFFICE OF EKING HAVE WEIGHS UNDER NIH OFFICE OF DIRECTOR SO OFFICE OF EVALUATION PERFORMANCE AND REPORTING ON THE DPKPSI HAS MENTION TO BEAR CAPTURE COMMUNICATE AND ENHANCE VALUE OF NIH RESEARCH THROUGH STRATEGIC PLANNING, PERFORMANCE MONITORING, EVALUATION AND REPORTING. WE ARE HOPING TO WORK CLOSELY WITH THIS OFFICE. TO ASSESS SABV POLICY UPDATE INTO BUSINESS PRACTICES SO WE LOOK FORWARD TO THAT. NOW WE RETURN TO NEW PARTNERS FOR SABV RESOURCE DEVELOPMENT AND FIRST AND FOREMOST, WE WOULD LIKE TO HIGHLIGHT AND MAYBE HIGHLIGHT THIS PARTNERSHIP, NOT BRAND NEW BUT IT IS ONGOING AND VERY IMPORTANT SO THE OFFICE OF RESEARCH ON WOMEN'S HEALTH AND NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES HAS ESTABLISHED A NEW PARTNERSHIP TO DEVELOP A PRIMER FOR SABV. IT'S GOING TO BE AN INTERACTIVE eLEARNING COURSE TO ENHANCE IMPROVE CONSIDERATION OF SABV TO RESEARCH DESIGN, ANALYSES AND REPORTING VERY CLOSELY TO THE SABV POLICY AS WRITTEN. IT'S A RESOURCE DESIGNING RESEARCH STUDIES AND PREPARING NIH GRANT APPLICATIONS AN TRAINING THE NEXT GENERATION OF INVESTIGATORS. AND THE AUDIENCE HOPEFULLY ARE GOING TO BE RESEARCHERS OF ANY LEVEL FROM PRE-DOCTORAL TRAINEES TO SENIOR FACULTY. WHAT I WOULD LIKE TO NOTE HERE IS DISCUSSIONS ABOUT SEX AND GENDER, THIS IS ON SEX. TO MAKE IT CLEAR, BECAUSE THE POLICY -- MOSTLY ABOUT PRE-CLINICAL RESEARCH, THERE WILL BE DISCUSSION OF FIELD SPECIFIC APPROACHES TO SABV BUT IT'S ABOUT SEX HERE. QUESTIONS DESIGNED BY DESIGNATED CONTRACTOR WITHIN INPUT FROM NIH DESIGNATED SUBJECT MATTER EXPERTS, DESIGNED AS FOUR MODULES, INTRODUCTORY MODULE, MODULE OR DESIGN ANALYSES AND REPORTING. WE'LL HAVE AN INSTRUCTOR GUIDE, A GLOSSARY AND REFERENCES SO WE'RE EXCITED ABOUT IT. ACTUALLY THE INDIVIDUAL ASKED ME YESTERDAY SO THEY'RE ALL WAITING FOR IT AND SOME OF THE GOALS ARE TO CLARIFY SABV POLICY, CREATE BETTER BUY IN AND TO ADDRESS WE RECEIVE LOTS OF QUESTIONS ABOUT CHALLENGES TO ADDRESSING SABV DOUBLING, THAT WILL BE ALL ADDRESSED WITHIN THE eLEARNING COURSE. MOST IMPORTANTLY WANT TO HELP INVESTIGATORS BETTER APPLY POLICY TO RESEARCH. AND AGAIN WE MAKE REFERENCES TO NOT ONLY BASIC PRE-CLINICAL RESEARCH BUT ALSO AS RELATES CLINICAL AND POPULATION HEALTH. ONE OTHER RESOURCE I TALKED ABOUT, I THINK I SKIPPED SOMETHING. YES. THIS COURSE CANNOT -- IS COMING AT AN OPPORTUNE TIME LOTS OF CONVERSATION ABOUT CURRICLUM DEVELOPMENT SABV. I WAS PLEASED TO SIT ON A PANEL AT LAST BIRCH MEETING NOVEMBER OF LAST YEAR AS PART OF THE BIRCH MEETING WE HAD AN AN EXPERT PANEL ON CURRICULUM DEVELOPMENT. THANKS FOR ORGANIZING THAT, VERY WONDERFUL COMPENSATION AND MAJOR QUESTIONS POSED TO THE PANEL DO SCIENTISTS UNDERSTAND HOW TO INCORPORATE SABV PRINCIPLES TO SCIENTIFIC THINKING. HOW DO WE TEACH INCORPORATION OF THESE IN ORDER TO CHANGE EXISTING PARADIGMS WHICH IS EXTREMELY IMPORTANT TO UPTAKE OF SABV AND HOW DO RESEARCHERS INCORPORATE SEXES AND/OR GENDERS TO THE RESEARCH WITHIN COST AND TIME CONSTRAINTS, QUESTIONS WE GET ALL THE TIME. SO IT WAS WONDERFUL PORTAL AND HOPE ANY WE'LL HAVE FOLLOW-UP AND CAPTURE, BE ABLE TO CAPTURE ESSENCE OF THE GOOD QUESTIONS AND CAME FROM THAT. TO OTHER SABV RESOURCES. DR. CLAYTON TALKED OTHER IC CO-FUNDS, OTHER IC CO-FUNDS WERE IMPORTANT TO OFFICE LIKE HOURS BECAUSE IT ALLOWS US TO BUILD SCIENTIFIC RESEARCH PARTNERSHIPS AND TO LEVERAGE OUR LIMITED RESOURCES. BUT IN MANY CASES, MOST CASE, IT PROVIDES FOR NIMBLE TIMELY ENGAGEMENT WITH NEW EMERGING RESEARCH OPPORTUNITIES FOR WOMEN'S HEALTH. THIS RFA IS ONE OF THEM. THIS WAS ISSUED BY NIGMS ENTITLED TRAINING MODULES TO ENHANCE RIGOR AND REPRODUCIBILITY OF BIOMEDICAL RESEARCH, AN R-25 MECHANISM FOR THOSE FAMILIAR WITH MECHANISMS AND THE GOALS ARE TO DEVELOP AN EXPORTABLE TRAINING MODULES IN AREAS WITH TENDED TO ENHANCE DATA REPRODUCIBILITY AND PROVIDE COMMUNICATION AND COORDINATION OF THE DEVELOPMENT AND DEPLOYMENT OF SUCH MODULES. SO THIS IS REALLY FOCUSED ON HOPEFUL SOME MIGHT FOCUS ON SABV. SO IF THERE IS A FOCUS ON SABV WE WOULD LIKE TO BE IN A POSITION TO USE CO-FUNDING TO SUPPORT THESE SUBJECT R-25. NEXT I WOULD LIKE TO HIGHLIGHT ANOTHER SABV RESOURCE, SEX AND GENDER INFO GRAPHIC NOW IN SPANISH. WE WOULD LIKE TO THANK THE STAFF AND THE OD TRANSLATED THIS INFO GRAPHIC INCLUDE IN THE PORTAL. SO NOW I WOULD LIKE TO SPOTLIGHT ON SABV APPLICATION TO THE SCIENCE. THE MARCH MEETING OF COORDINATING COMMITTEE ON RESEARCH WOMEN'S HEALTH HERALD A HEARD A GREAT PRESENTATION FROM DR. GEORGE KOOB FROM ALCOHOL ABUSE AND ALCOHOLISM. AND HIS TITLE WAS EMERGING RESEARCH ON ALCOHOL AND WOMEN'S HEALTH. WHAT DO WE KNOW AND WHERE DO WE GO FROM HERE? BEFORE I TALK TALK ABOUT HIS PRESENTATION WHICH IS QUITE COMPREHENSIVE I WOULD LIKE TO SAY THIS -- THE COORDINATING COMMITTEE -- THE LEVEL OF ENGAGEMENT WE HAVE HAD WITH THE ICs NIH DIRECTORS, COME TO SPEAK TO US HAS BEEN WONDERFUL AND IT IS A GREAT PLATFORM FOR DIRECT INTERACTION BETWEEN ORWH AND THE ICs. AND IT DOES HELP ACCOUNT FOR STRATEGIC PLAN. SO A BIT ABOUT THE MAIN THEMES OF HIS PRESENTATION. HE WANTED TO TALK WITH US TO DISCUSS GAPS BETWEEN MEN AND WOMEN AND PREVALENCE OF ALCOHOL ALCOHOL AND ALCOHOL RELATED HABITS HIS TALK WAS ABOUT SEX DIFFERENCES IN WOMEN'S HEALTH. BUT HE TALKED ABOUT ARE THERE SEX DIFFERENCES IN EVERY STAGE OF ADDICTION CYCLE. WHAT LEADS TO THESE DIFFERENCES. AND ALSO IMPORTANTLY TALKED THE ROLE OF CHRONIC PAIN AND STRESS AT THE INTERFACE OF ALCOHOL MISUSE IN FEMALES P AGAIN CANCER PRESENTATION, I'M GOING TO SHOW YOU A FEW SLIDES FROM HIS TALK. HE DISCUSSED I WILL SAY ALL DIMENSIONS OF WOMEN AND ALCOHOL ABUSE DISORDERS INCLUDING EPIDEMIOLOGY, NEUROBIOLOGICAL MECHANISMS AND SOCIOLOGICAL ASPECTS OF DRINKING AND ALCOHOL ABUSE. SO HERE WAS ONE OF HIS SLIDES. I'M JUST GOING TO TAP INTO THE TITLE HERE. IN THE INTEREST OF TIME BUT HE SAID, MORE WOMEN ARE DRINKING AND THEY ARE DRINKING MORE OFTEN. AND YOU CAN SEE IN THIS SLIDE HERE, WOMEN ARE THE LIGHT BLUE BAARS ON THE BOTTOM, AND YOU SEE THIS SLEEP IS GOING UP. FROM 2002 TO 2012, PERCENT OF WOMEN DRINKING CURRENT DRINKING AND NUMBER OF DRINKING DAYS IS INCREASING, COMPARED TO THOSE OF MEN ON THE UPPER PANEL WITH A SLOPE IS NEGATIVE AND GOING DOWN. ONE OF THE THEMES OF HIS PRESENTATION WAS ABOUT PRE-ADOLESCENCE. SO I HAVE A FEW SLIDES ON PRE-ADOLESCENCE. ONE OF THE SLIDES AMONG TEENS, ALCOHOL CONSUMPTION IS DECREASING LESS FOR FEMALES THAN MALES. ANOTHER, THE BRAIN UNDERGOES WIDESPREAD SEXUAL DIFFERENTIATION DURING ADOLESCENCE AND THE IMPLICATIONS FOR THAT. ALCOHOL INDUCES MORE DOPAMINE RELEASE IN MALE THAN FEMALE NUCLEUS SECUMBENS SECUMBENS, ONE TOPIC FOR ORWH IS CONTINUING CONCERNS ABOUT ALCOHOL FETAL AND MATERNAL HEALTH. SO THIS IS A SNAP SHOT OF THE WONDERFUL PRESENTATION HE GAVE. WAS INDICATIVE OF THE THEMES ORWH CAN WORK WITH NIAAA. NEXT I TALK A LITTLE BIT ABILITY THE ABCD STUDY DATA SET. SO USING THE ADOLESCENT BRAIN COGNITIVE DEVELOPMENT DATA SET THIS STUDY, BY GORH AM AND COLLEAGUES FIND A RELATIONSHIP BETWEEN SEX SPORTS ACTIVITY AND MENTAL HEALTH IN PRE-ADOLESCENCE. AS YOU KNOW THE ABC DATA SET IS FUNDED BY NIDA TRIPLE A AND DOES HAVE ORWH SUPPORT. IMPORTANTLY THE DATA SET IS LARGE. THIS PARTICULAR STUDY THEY LOOKED AT 4,000 CHILDREN AGE 9 TO 11. VERY LARGE DATA SET. AND THEY SAID THEIR FINDINGS. FIRST THEY FOUND GREATER SPORTS INVOLVEMENT BUT NOT NON-SPORT ACTIVITY INVOLVEMENT WAS ASSOCIATED WITH LESS DEPRESSION IN BOYS. SO THIS GETS AT SEX DIFFERENCES. INVOLVEMENT IN ALL TYPES OF SPORTS EXCEPT FOR INDIVIDUAL SPORTS, AND NON-SPORTS ACTIVITIES WAS RELATED TO HIPPOCAMPAL VOLUME IN BOTH BOYS AND GIRLS. WHAT'S THE RELATIONSHIP BETWEEN HIPPOCAMPAL VOLUME AND DEPRESSION? FOR BOYS THERE IS A RELATIONSHIP BETWEEN HIPPOCAMPAL VOLUME AND DEPRESSION BUT FOR GIRLS NOT SO MUCH. HERE IS THE DATA, JUST ONE PART OF THE DATA YOU SEE HERE THEY ARE LOOKING AT THE DEPRESSION T SCORE AND AVERAGE HIPPOCAMPAL VOLUME AND YOU SEE HERE THAT THE LINE FOR FEMALES IS BASICALLY FLAT MEANING BASICALLY NO RELATIONSHIP. AS OPPOSED TO THE THE DOTTED LINE, THE NEGATIVE RELATIONSHIP SO THE GRADING SCORE GREATER THE SCORE SMALLER HIPPOCAMPAL VOLUME. THERE'S CONTROVERSY ABOUT HIPPOCAMPAL VOLUME BUT REMEMBER THIS DATA SET HAS ANALYZED OVER 4,000 CHILDREN. SO OF THE E VERY RIGOROUS AND THIS IS JUST A FIRST PASS THIS EVOLVING DATA SET YOU MIGHT BE AWARE THERE'S A RELEASE OF OTHER -- THE DATA SET OF 7500 DATA SET OF 7500 HAS BEEN RELEASED FROM THE ABCD STUDY. IS AVAILABLE FROM THEIR WEBSITE FROM THE WEBSITE. SO LOOKING FOR GREAT THINGS FROM THIS DATA SET IT DOES HAVE ORWH SUPPORT. LIKE TO TALK NOW ABOUT SOMETHING THAT HAPPENED RECENTLY, ORWH HOST AD GWAS SEX AND CHROMOSOMES THINK TANK ON FEBRUARY 27 THIS YEAR. IT WAS ATTENDED BY 15 INSTITUTES AND CENTERS AND OFFICES. THE IMPETUS FOR THIS IN PART WAS A STUDY BY THE SENIOR -- ONE OF OUR SCORE DIRECTORS, DR. MILLER INVESTIGATING CARDIOVASCULAR ISSUES AND GENETICS. OUT OF THAT CAME A REVIEW OF THE RELATIONSHIP BETWEEN GW ABS AND NUMBER OF GENE AND RELATIONSHIP WHAT GENES WERE CHROMOSOMES STUDIED IN GWAS STUDIES. SO THIS IS SOME OF THE QUESTIONS THAT THE GWAS THINK TANK DISCUSSED. FIRST WHAT FACTOR EXPLAIN UNDERREPRESENTATION OF SEX CHROMOSOMES IN GWAS RESULT? HOW MUCH INFORMATION IS LOST? WHEN SEX CONTROL FOR STATISTICALLY BUT THE INFLUENCE OF SEX IS NOT REPORTED. IMPORTANTLY THERE MIGHT BE MANY REASONS FOR THIS MIGHT BE BECAUSE WE DON'T HAVE THE TECHNOLOGY FOR INSTANCE. BUT ARE THERE EMERGING SOLUTIONS TO THESE ISSUES. SO I JUST HIGHLIGHT WITHIN OF THE GRASPS FROM THE REVIEW, YOU CAN SEE HERE THAT X AND Y ARE NOT PRESENTED VERY MUCH IN GWAS STUDIES. I WOULD LIKE TO JUST OUT OF THAT THINK TANK COMING SOON WILL BE A THINK TANK SUMMARY POSTED ON OUR WEBSITE. WE HAVE A LITTLE BIT, IT'S NEW BUT WE'RE CALLING OURSELVES THE GENDER AND GENOME CORE. THE CO-CHAIRS ARE HERE, DR. MATT AND JAMIE WHITE. ELAINEA GARDINSKI ARE MEMBERS OF THE COMMUNITY JUST BEGINNING TO THINK ABOUT WHAT IS NEXT BUT SOON YOU WILL SEE THIS -- A SUMMARY OF THIS ON OUR WEBSITE. I THINK YOU ARE ALL AWARE COMING SOON TO WASHINGTON D.C. IS THE ORGANIZATION FOR THE STUDY OF SEX DIFFERENCES AND THE INTERNATIONAL SITE FOR GENDER MEDICINE JOINT MEETING. AND YOU ARE AWARE OUR PRESIDENT OF THE MEETING MEETING MEETING IS HERE KLE IN. IT WILL BE RIGHT DOWN THE STREET SO WE HAVE A PRESENCE AS DR. CLAYTON MENTIONED OF PRESENCE IN -- MORE THAN ONE WAY BUT ORWH SCORES AT OSD IGM, THEY HAVE OUR CURRENT SCORE PI SO WE'RE GOING TO BE IN SESSION. DR. KLEIN IS CHAIRING AND DOING IT ALL, SHE HAS A PRESENTATION ON VACCINE INDUCED IMMUNITY AGAINST INFLUENZA, IN SESSION 8 DR. MILLER, SHE AND (INDISCERNIBLE) OF ANOTHER SCORE I GOING TO HAVE A SECTION ON SEX HORMONES AND ADVERSE DRUG REACTIONS. OUR PRIOR SCORES ARE STILL ACTIVE. WE HAD A PRIOR -- YOU KNOW THE SCORE WAS P 50 NOW A U-54. SHERRI MCKEY PRIOR SCORE PI IS CHAIRING A SESSION ON SEX DIFFERENCES IN NICOTINE AND SMOKING FOR BRAIN AND BEHAVIOR TO SMOKING CESSATION. I'M SURE I LEFT OUT SOME SCORE PIs, I UNDERSTAND THERE MIGHT BE SOME AWARDS OR -- BUT WE REALLY ARE VERY HAPPY THAT OUR SCORES ARE VERY ACTIVE IN AT THIS MEETING. WITH THAT THANK YOU AND I'LL TAKE ANY QUESTIONS YOU HAVE. THANK YOU. >> THANK YOU, DR. HUNTER. FLOOR IS OPEN FOR QUESTIONS. I HAVE TWO, FIRST THE NEW MODULES YOU ARE CREATING AND YOU EMPHASIZE SEX AND NOT GENDER, YOU MADE THE POINT IT WAS BECAUSE IT WAS PRE-CLINICAL, AT A BARE MINIMUM IT REALLY IS IMPORTANT THAT ENVIRONMENTAL FACTORS WHICH OFTEN PEOPLE USE AS THE SYNONYM FOR GENDER IS CONSIDERED, BECAUSE WE ACTUALLY HAD A WORKSHOP AT STANFORD WHERE SEVERAL PEOPLE HERE WERE THERE. WE TALKED ABOUT THE FACT THAT ENVIRONMENTAL CONDITIONS ARE VERY DIFFERENT FOR MALE AND FEMALE RODENTS. THEY HOUSE THEM VERY DIFFERENTLY, THEY HAVE THE TEMPERATURE SET FOR THE MALE RODENT, NOT THE FEMALE RODENT. SO IT'S AFFECTING THE BIOLOGY AND REALLY PROFOUND WAYS, THAT TECHNICALLY IS GENDER BUT WE EXCLUDE GENDER TO HUMAN SO I THINK IT'S REALLY IMPORTANT GENDER DISCUSSION COME INTO THESE MODULES AS WELL. >> HOLD ON ONE SECOND. >> I GUESS I WOULD LIKE TO SAY THE SABV POLICY IS ROOTED IN RIGOROUS REPRODUCIBILITY -- REPRODUCIBLE RESEARCH. SO WHEN YOU ARE STUDYING SEX YOU SHOULD BE DOING IT RIGOROUS REPRODUCIBLE WAY, BEING COGNIZANT OF THE CONDITIONS THAT THE ANIMALS ARE HOUSED IN, SO WE TAKE YOUR POINT, ACTUALLY THERE'S -- I KNOW THERE'S SOME INSTITUTES THAT ACTUALLY INVESTIGATE THIS THOROUGHLY. I THINK IT'S A COOPERATIVE AGREEMENT BUT THEY ACTUALLY DO TESTING IN SEVERAL DIFFERENT INSTITUTES, SEVERAL DIFFERENT SETTINGS AND ANALYZE ANALYZE THE DATA TO SEE IF THE ENVIRONMENT IS IN FACT HAVING A IMPACT ON THE DATA. YES, THIS IS PART OF RIGOROUS REPRODUCIBLE RESEARCH. >> IN THAT REGARD I CAN SAY MANY PSYCHOLOGISTS PRESENTING A RODENT DATA FORGET THE FACT IF YOU HAVE THREE OR FOUR FEMALE RODENTS IN A CAGE TOGETHER, THAT'S TOTALLY DIFFERENT FROM HAVING ONE MALE IN A CAGE TOGETHER. SO WE NEED A LOT OF RIGOROUS ATTENTION TO THESE POINTS SO THAT'S THE POINT I WANT TO MAKE. WE ARE WORRYING ABOUT IN GENDER, IN HUMANS IS SOMETHING THAT WE DO NEED TO WORRY ABOUT IN THE ANIMAL RESEARCH, JUST HOW THE WORDS ANIMAL RESEARCH EFFORTS ARE COMFORTABLE USING. >> AGAIN, TO ECHO DR. HUNTER'S POINT SABV POLICY HAS A SEPARATE POLICY BUT THERE IS A SEPARATE ON REPRODUCIBILITY AND RIGOR AND TRANSPARENCY ONE ELEMENT IS THE PREMISE, RIGOR RELEVANT BIOLOGICAL VARIABLES SUCH AS SEX BUT NOT JUST SEX. AND THIS ISSUE ABOUT HUSBANDRY HOW YOU TRANSPORT, ALL THOSE ISSUES WERE DISCUSSED IN THE CONTEXT OF ENHANCING REPRODUCIBILITY AND THE FACT THAT WE NEED TO APPROACH BASIC SCIENCE ANIMAL EXPERIMENTS WITH APPROPRIATELY GOSH SO THAT WE DESIGN THEM IN A WAY FOR INFORMATION INFORMATIVE AND INTERPRET IN THE CONTEXT OF THAT. AS YOU ARE ALLUDING TO MARSHA, IS JUST ONE PIECE OF RIGOR ESPECIALLY IN THAT CONTEXT. >> I THINK THE MORE WE EDUCATE ANIMAL RESEARCHERS TO THAT THE MORE THEY'RE GOING TO UNDERSTAND HOW IMPORTANT IT IS TO GET GENDER TO THE WHOLE CONVERSATION. IF I HAVE ONE MORE POINT, THE SLIDES YOU ARE SHOWING ABOUT ALCOHOL AND THE EVIDENCE THAT WAS BEING PRESENTED I ABSOLUTELY AGREE THAT THE BRAIN IS EVOLVING AS ADOLESCENCE BUT THIS IS WHERE THE DISCUSSION CAME UP LAST NIGHT AT DINNER WHERE NEUROSCIENTISTS ARE REALLY DISCUSSING NEUROFEMINISM ISSUES IS THAT STUDY SHOWN BRAIN CONE ACTIVITY WHICH IS ENTERAND INTRAHEMISPHERIC IDEA IF YOU LOOK AT THE COINS DION THAT, THERE'S SO LITTLE DIFFERENCE, THERE'S NOT A SIGNIFICANT DIFFERENCE SO THERE'S A STATISTICAL MODEL THAT MAKES IT LOOKS LIKE THE FEMALE HAS INTERHEMISPHERIC CONDITION SO THE SCIENCE OF THAT STUDY NEEDS TO BE STUDIED THOUGH THE ENDS ARE HUGE, IF YOU LOOK AT THE DEVELOPMENT OF AD LESS SEASONS THEY GO THROUGH THE CHILD, THEY HAVE CHILDREN AGE 5 TO 8, I FORGET WHAT THE CATEGORIES ARE, BUT THE EVIDENCE DOES NOT SHOW UP, IT WAS A STATISTICAL MODEL THAT'S BEING CITED AS EVIDENCE THAT IS NOT THE RIGHT EVIDENCE. SO THIS IS WHERE I HAVE MY TROUBLES BECAUSE THE NEUROSCIENTISTS AND ALSO THE NEXT SLIDE THAT WAS ON THAT, I DON'T KNOW IF YOU KNOW BUT I KNOW THESE SLIDES BECAUSE OBVIOUSLY ACTIVELY ENGAGED TO BE IN PLACE THE RED BLUE SLIDE WHERE THIS IS THE RED IS, THE FEMALE DOMINANT AREAS AND THE BLUE, I DON'T THINK THEY ADJUSTED FOR BRAIN SIZE ON THOSE, SO I THINK THAT IN THE NEUROSCIENCE WORLD THERE IS A LOT OF WORK THAT NEEDS TO BE DONE TO REALLY TEASE THIS APART AND PROBABLY KNOWS MORE ABOUT IT THAN I DO MAYBE NOT, THIS IS SOMETHING EVERY DAY, I FEEL LIKE WE HAVE SO MANY PLACES WHERE WE JUST HAVE TO BE VERY CAREFUL OF HOW PEOPLE ARE DOING THIS RESEARCH TOE RECOGNIZE FEMALES ARE SMALLER THAN MALES IF YOU ADJUST FOR BRAIN SIZE THE HIPPOCAMPAL THINGS, AMYGDALA THINGS FALL AWAY, THESE ARE IMPORTANT SCIENTIFIC QUESTIONS THAT WE NEED TO GET BETTER SCIENCE ON. >> DID YOU WANT TO COMMENT >> BRIEF COMMENT. I THINK IN THIS FIELD IN THE -- PEOPLE ARE VERY MUCH AWARE OF THE SIZE OF BRAIN AND SIZE OF THE BODY MEASURE UP AND THERE ARE PLENTY OF SEX DIFFERENCES THAT EXCELLENT EXAMPLES THAT PEOPLE MAKE MUCH VERY SMALL SEX DIFFERENCE. SEX DIFFERENCE IN THE OPIOID RECEPTORS DIDN'T IMPRESS VERY MUCH, WE SAW TODAY VERY TINY, BUT THERE ARE HUGE SEX DIFFERENCES LIKE A NUMBER OF X CHROMOSOMES PER CELL AND EPIGENETIC MACHINERY NEEDED FOR (INAUDIBLE) WHICH IS INCREDIBLE SEX DIFFERENCE AND THE IMPLICATION OF THAT SEX FUNCTION WE DON'T KNOW TOO MUCH OF MY GUESSES. VERY IMPORTANT. >> I WANT TO BE SURE THAT AS THE ORWH IS PRESENTING INFORMATION THEY ARE CAREFUL ABOUT WHAT THEIR PRESENTING AS WELL, THESE ARE DEBATABLE ISSUES THAT NEED REALLY GOOD DISCUSSION BEFORE WE IMMEDIATELY START SITING THEM AS EVIDENCE FOR WHY WE NEED TO DO THIS WHEN IN FACT THEY'RE NOT THE EVIDENCE FOR THAT, EVIDENCE FOR SOME OTHER VERY IMPORTANT THING YOU ARE PROMOTING. THAT'S MY POINT. I'M EMOTIONALLY CHARGED ABOUT THIS. >> THANK YOU VERY MUCH FOR YOUR INPUT. YOU UNDERSTAND DR. HUNTER'S INTENTION WAS TO CONVEY THE PRESENTATION OF DR. KOOB, THE WAY I THINK ABOUT THIS, YOU CAN OFTEN FIND STATISTICALLY SIGNIFICANT INFERENCES WHAT WE ARE LOOKING FOR ARE SCIENTIFICALLY IMPORTANT CLINICALLY MEANINGFUL DIFFERENCES, THAT IS A REASON I PREFER TO USE THE TERM INFLUENCES RATHER THAN DIFFERENCES THAT HELPS YOU TO UNDERSTAND HOW NUANCED AND COMPLICATED THIS IS. SO JUDY AND THEN NOELLE AND THEN WE SHOULD GO TO DISCUSSION. >> THIS IS HIGH HEIGHTS HOW MUCH WE NEED TO DO THIS IS A PIONEERING FIELD FOR SEX AND GENDER WOULDN'T T NOW WE HAVE THE OPPORTUNITY TO TALK BY DR. HUNTER HIGHLIGHTED ISSUES AND YOUR COMMENTS PERFECTLY HIGHLIGHT THE PIONEERING NATURE WHAT WE HAVE TO DO WHICH IS PART OF WHAT MAKES IT SO EXCITING TO DELVE INTO BUT THERE'S A LOT OF WORK AHEAD OF US. >> THE SURVEY OF THE REVIEWERS SEX AS A BIOLOGICAL VARIABLE IS VERY HELPFUL, BUT I WOULD AGREE DR. HUNTER AT 15% RESPONSE RATE IS PROBABLY NOT WHAT WE ARE LOOKING FOR. SO ARE WE CHARGING THE OFFICE FOR SCIENTIFIC REVIEW TO SUMMARIZE THOSE STATEMENTS BECAUSE WE ARE ALL REQUIRED TO SAY DID THEY ADDRESS RIGOR, DID THEY ADDRESS SABV, IT'S THERE NOW. THE PROJECT OFFICERS MAY OR MAY NOT BE PAYING ATTENTION TO IT. THE CENTER FOR SCIENTIFIC REVIEW SHOULD BE ABLE TO PROVIDE DATA EVEN IF WE HAVE TO DO NATURAL LANGUAGE SEARCHING WHICH NOW EXISTS. >> THEY'RE NOT METRICKING IT. >> DO YOU WANT TO MAKE A COMMENT? >> I SAY THAT GOOD START IS THIS NEW OFFICE OF EVALUATION, I THINK THAT WE ARE NOW CHARGED IT'S NOT ONLY NIH BUT ACROSS THE ENTIRE GOVERNMENT. I THINK IT'S A GOOD I THINK A PERFECT WAY TO START WITH TO DO SUCH AN EVALUATION ON SABV. OF COURSE YOU HAVE TO ENGAGE THE CENTER FOR SCIENTIFIC REVIEW. ONE OF THE ISSUES THAT WAS BROUGHT UP ABOUT THE STUDY IS THAT OF COURSE THERE'S ONLY 10, 15% AND IN REVIEWERS ARE PLEDGED TO CONFIDENTIALITY. SO SOME OF THE LIMITATIONS OF THAT STUDY ARE THAT ALSO. OF COURSE WE NEED TO ENGAGE CENTER FOR SCIENTIFIC REVIEW AND I'LL LEAVE IT TO YOU DR. CLAYTON TO GIVE COMMENTS ON THAT. >> I WANT TO AFFIRM THAT WAS NOT AN NIH STUDY. BUT WE DID THINK IT WAS IMPORTANT TO SHARE THAT WITH YOU AND HAVE AN OPEN AND TRANSPARENT CONVERSATION ABOUT THAT. AS DR. HUNTER HAS INDICATED PRELIMINARY DISCUSSIONS WITH THIS NEW OFFICE ABOUT SABV AND WE DO HAVE SOME IDEAS AND WAYS WE CAN MOVE FORWARD. NOELLE WE ARE WORKING REALLY HARD WITH THE VARIOUS GOVERNANCE GROUPS SO, THERE'S A GOVERNANCE GROUP FOR SROs SO WE ARE WORKING WITH THEM AND WORKING WITH PROGRAM OFFICIALS TO CONTINUE TO ORIENT US ALL TO THE SABV POLICY, WHAT THAT MEANS IN DIFFERENT CONTEXTS, SO WE ARE TRYING TO ADDRESS MULTIPLE LEVELS IN A WAY THAT IS LIKELY TO EFFECT THE CHANGE WE WANT TO SEE. SO THAT'S THE BOTTOM LINE, KEEP OUR EYE ON WHAT WE ARE TRYING TO SEE. AND WHAT IS THE BEST WAY TO GET TO THAT. YOU HAVE TO COME AT IT FROM MULTIPLE SIDES BUT APPRECIATE YOUR INPUT. DR. KLEIN. >> SO ONE OF THE THINGS THAT I HAVE NOTICED AT LEAST IN BOTH MICROBIOLOGY AN IMMUNOLOGY. >> DO YOU WANT TO COME TO THE TABLE SHARON? WE MORPHED INTO THE DISCUSSION SESSION. >> YES. >> ONE OF THE OBSERVATIONS THAT I MADE AND THROUGH TALKING WITH COLLEAGUES, OBVIOUSLY ABOUT SOME OF THE CONFUSION ABOUT THE SABV POLICY AND ONGOING DISCUSSIONS, THIS DOESN'T MEAN EVERYBODY HAS TO DOUBLE NUMBER OF ANIMALS, SO THAT'S AN ON GOING QUESTION. BUT THEN THERE'S THE FOR LACK OF BETTER TERM LIP SERVICE PAID TO GRANT WRITING BUT THAT DOESN'T NECESSARILY TO TRANSLATE INTO WHAT PEOPLE ARE DOING. I HAVE BEEN VERY FRUSTRATED BY THIS, YOU CLAIM YOU ARE GOING TO ADDRESS IT IN THE GRANT PROPOSAL THEN PAPERS THAT COME OUT FROM THAT GROUP NEVER ADDRESS IT. THE BIASES ARE STILL THERE, LACK OF REPORTING IS STILL THERE. SO I THINK AROUND THIS TABLE ARE SO MANY -- THE CHANGE IS GOING TO COME WHEN WE START TO CHANGE JOURNAL POLICIES IN ORDER TO PUBLISH IN THESE HIGHLY IMPACTFUL JOURNALS IN EACH OF OUR FIELDS. ONCE THEY START REQUIRING REPORTING. AND CONSIDERATION OF THIS. THEN WE WILL SEE CHANGE. SO I JUST WANTED TO -- >> LONG STANDING ISSUE AS YOU KNOW, ORWH HAS HAD THREE WORKSHOPS WITH PUBLISHERS AND JOURNAL EDITORS BEFORE MY TIME. IT'S IMPROVING BUT IT IS AN ONGOING, YOU WOULD HAVE TO ASK THAT OF THE PEOPLE THAT WILL ARE RESISTING, I THINK MANY ARE REPRESENTED BY Y'ALL AROUND THIS TABLE. YOU ARE ON EDITORIAL BOARDS, YOU ARE EDITORS. YOU CAN INFLUENCE POLICIES IN THAT SPACE OR POTENTIAL TO INFLUENCE POLICIES IN THAT SPACE AND THE SAME GUIDELINES EXIST NOW SO EASY TO SIGH SAY WHY NOT JUST ADOPT THESE? THOSE -- THAT'S A STRATEGY THAT OTHERS MIGHT EMPLOY, WE ARE ADVOCATING FOR STRATEGIES THAT AND APPROACHES AND GUIDELINES THAT ARE ALIGNED WITH SABV POLICY AND THAT ARE CONSISTENT WITH GOOD SCIENCE. JOURNAL EDITORS AND PUBLISHERS HAVE A CRITICAL STAKEHOLDER ROLE. SO DR. HUNTER DID MENTION THIS OTHER PIPER AND THAT'S -- PAPER MENTIONEDDED THIS OTHER PAPER, THAT'S NOT A CRITICISM, I WAS JUST THINKING, I THOUGHT THAT ARTICLE WAS THE STACY GOALER PAPER AND STACY IS A NEW MEMBER, SHE LOOKED AT PUBLICATIONS OF NIH DEFINED PHASE 3 CLINICAL TRIALS AND STILL LESS THAN A THIRD AND NO IMPROVEMENT OVER TEN YEAR PERIOD SO FOR EVERYONE FEWER THAN THIRD OF NIH DEFINED PHASE 3 CLINICAL TRIALS HAVE ANY SEX DISAGGRAVATED DATA AND SEMINOLE PUBLICATIONS FROM THAT FUNDING. THAT'S DISTURBING. THE GOOD PART ADS YOU HEARD FROM DAWN CORBETT, APPLICABLE CLINICAL TRIALS WHICH MANAGE TO FIND PHASE 3 CLINICAL TRIALS ARE APPLICABLE, THEY COVER FDA REGULATED PRODUCTS WILL NOW HAVE TO PUT THEIR RESULTS BY SEX GENDER RACE ETHNICITY INTO CLINICAL CLINICALTRIALS.GOV WITHIN A YEAR OR PRIMARY COMPLETION DATE. THAT IS THE GOOD NEWS, THE MOST DISTAL LEVER AND POINT OF CONTROL. WE ARE OPEN TO IDEAS WAYS TO IMPROVE THE SEX SPECIFIC. RACHEL, DAVID AND NOELLE BACK TO YOU. >> >> SO THE 10, 15% RESPONSE RATE SHOWS A (INDISCERNIBLE) IN ITSELF. I WANT TO MENTION IT AGAIN, I MENTIONED BEFORE. BECAUSE I THINK THAT THERE IS SO MUCH INTERPRETATION IN WHAT IS JUSTIFIED AS A SINGLE GENDER STUDY. IT IS MY EXPERIENCE IN GENERAL IN SCIENTIFIC REVIEW SESSIONS, GENERAL AND REVIEWING MANUSCRIPTS RELATED TO HIV AIDS, THERE ARE JUSTIFICATIONS FOR STUDYING MEN ONLY. BECAUSE THIS IS MEN WHO HAVE SEX WITH MEN. THAT'S IN TERMS OF HIV AIDS, VERY IMPORTANT PRIORITIES, PROBLEM IS MEN WHO HAVE SEX WITH MEN ALSO HAVE SEX WITH WOMEN. IF THE REVIEWER THINKS IT IS OKAY DIRECTOR OF MEN AND -- SO IT'S JUST OKAY TO LOOK AT MEN THEN WE LOSE A VERY IMPORTANT ASPECT OF HIV TRANSMISSION IN WOMEN, THAT WORRIES ME AND KEEPS ME UP AT NIGHT. THE SECOND PROBLEM IS I HAVE SEEN MANUSCRIPTS, THAT -- TWICE NOW IN RECENT PERIOD THAT SHOW POPULATION MSM STUDY, MEN WHO HAVE SEX WITH MEN STUDY, AND IT SHOWS THAT THE SHOWS IN A CERTAIN PROPORTION OF MEN WHO HAVE SEX WITH MEME ALSO HAVE SEX WITH WOMEN. THEN DROP A STORY SO CARRYING INTO THE RESULT SECTION INTO THE DISCUSSION SECTION IT DROPPED SOD YOU SHOW IT IN IN A TABLE HOW MANY MEN WHO HAD SEX WITH MEN, SEX WITH WOMEN AS WELL, ANYONE THRENE'S NOTHING IN DISCUSSION SECTION WHICH HAS IMPORTANT IMPLICATIONS FOR TRANSMISSION OF SEXUALLY TRANSMITTED INFECTION INCLUDING HIV AIDS, AND SO WHAT CONCERNS ME TO GET TO THE CENTRAL POINT, IS THAT THE ARGUMENT FOR THE SINGLE GENDER SING SYSTEM SEX STUDY REALLY IS ONE THAT HAS TO BE PROBED MORE. THE JUST IS THE JUSTIFICATION >> GIVING US SOMETHING SERIOUS THINK ABOUT, THANK YOU FOR BRINGING THAT UP. DAVID. >> SO THANK YOU FOR YOUR PRESENTATION, I WAS DELIGHTED TO HERE THAT ORWH IS DRAWING ATTENTION TO THE VIRTUAL DELETION OF THE CHROMOSOMES FROM THE GENOME IN GWAS STUDIES. TO MY UNDERSTANDING, THAT PROBLEM OF COURSE HAS BEEN KNOWN IN IMAGE -- IN THE GENETICS COMMUNITY FOR SOME YEARS. TO MY OBSERVATION, THERE HAS BEEN ALMOST NO MOVEMENT TOWARDS CORRECTING THE PROBLEM DESPITE SOME DISCUSSION OF IT FOR YEARS. THEN LET ME OFFER A FRIENDLY AMENDMENT TO YOUR SLIDE. THERE IS SOMETHING WRONG WITH THE SCALE ON THE GENES I'M THINKING RESISTANCE INNATE RESISTANCE WITHIN THE GENETICS COMMUNITY SO I WANT TO HELP YOU PROOF THAT SLIDE BEFORE YOU TROT OUT IN FRONT OF GENETICS COMMUNITY. >> POSSIBLE PRACTICAL BUT MAYBE NOT OKAY SUGGESTION, THESE ARE ALL NIH FUNDED PHASE 3 TRIALS AND THEREFORE EVENTUALLY THE DATA NEEDS TO BE DELIVERED BACK TO NIH FOR SHARING. I HAVE TO DO THAT WITH MY COHORT STUDIES. >> AFTER COMPLETION OF STUDY YOU ARE REQUIRED, WELL MAYBE THIS IS AN NHLBI EXCLUSIVE INSTITUTE POLICY YOU NEED TO MAKE THAT DATA AVAILABLE TO THE NIH AND THEY WILL MAKE IT AVAILABLE TO SELECTED PERSONS. YOU CANNOT PROVIDE ANYTHING YOU DIDN'T CONSENT TO PROVIDE. YEAH. WE HAVE HAD TO DO THAT WITH MULTIPLE STUDIES. >> MY UNDERSTANDING THE FINAL PROGRESS REPORT IS THE LAST PLACE WE GET INFORMATION. >> BECAUSE I HAD TO PROVIDE NHLBI WITH A NUMBER, IT'S PROBABLY NOT GOING TO HELP EXCEPT NHLBI THERE'S AMAZING CHINESE GROUP THAT DO META ANALYSES AND THEY PUBLISH LIKE CRAZY. EACH ONE DOES SEX SPECIFIC ANALYSES FOR EACH STUDY BECAUSE THEY CAN. OR WE CAN. SO I HEAR YOU SAYING THERE IS THE OPPORTUNITY TO ANALYZE LARGE AMOUNTS OF DATA. PEOPLE WITH THAT CAPACITY TO DO THAT. AND THAT YOU HAD TO PROVIDE YOUR MEAT DATA AT THE END OF YOUR STUDY EVEN IF THE GRANT PERIOD ENDED. CAROLYN, YOU ARE SAYING -- >> SOME INSTITUTES REQUIRE THAT. >> THIS IS NOT -- IT'S NOT LIMITED TO HEART LUNG AND BLOOD. THERE ARE MANY, MANY EXAMPLES OF LARGE DATA SETS AND I THINK IT'S LARGE DATA SETS WHAT PEOPLE WANT, ESPECIALLY LONGITUDINAL MULTI-WAVE DATA SETS AND THERE ARE PLENTY IN DRUG ADDICTION AND DEPRESSION IN VARIETY OF AREAS I'M AWARE OF SO I'M SURE IT'S NOT LIMIT TO ONE INSTITUTE. THE CONCEPT BEHIND IT IS THE GOVERNMENT AND TAXPAYER PAID FOR THIS. AND IT OUGHT TO HAVE THEN OPEN ACCESS AFTER CERTAIN NUMBER OF YEARS SO THAT ANYBODY CAN MINE THE DATA THE WAY YOU SAY, AND WE FOUND, WE HAVE OFTEN USED IT TO BUILD MODELS. IT'S GREAT FOR THAT PURPOSE BECAUSE YOU HAVE THOUSANDS OF PEOPLE OVER MULTIPLE WAVES, YOU CAN LOOK AT PRE-AND POST EVENTS AND DO ALL SORTS OF THINGS SET UP IN IMPERIAL STUDY. SO I THINK SHARON AND OTHERS CAN -- >> GIVE DR. HUNTER A CHANCE TO RESPOND. >> MAY HAVE A COMMENT AND THEN TO DR. GREGORY. >> I WANTED TO SAY THAT IN TERM OF OPEN ACCESS THAT'S WHERE NIH IS GOING. BECAUSE PUBLIC IT IS A PUBLIC FUNDS. AND YOU MIGHT FIND THAT IN YOUR THE FUNDING OPPORTUNITY THAT YOU ARE APPLYING TO, THAT IT'S WRITTEN IN YOUR NOTICE OF GRANT AWARD. >> MARGARET DID YOU WANT TO SAY ANYTHING? >> I WAS GOING TO SUPPORT WHAT DR. HUNTER WAS SAYING THERE ARE PUBLIC ACCESS POLICIES. AND THERE'S A SPECIFIC ONE FOR GENOMIC DATA SHARING. SO I'M GOOGLING AS FAST ADS I CAN TO PULL IT UP BUT MAYBE WE CAN MAKE THOSE SPECIFIC POLICIES AVAILABLE AND ALSO MAKE COMMENTS ON THOSE BASED ON THIS CONVERSATION. >> DR. GREGORY. >> I WANTED TO CIRCLE BACK TO THE POINT THAT DR. KLEIN WAS ALLUDING TO, THE ACCOUNTABILITY. YOU WROTE A GRANT THAT SAID YOU'LL DO X THEN YOU DIDN'T DO X. OR YOU DECIDED NOT TO PUBLIC X. -- PUBLISH X. IF WE FEEL IT'S THAT IMPORTANT THEN THERE OUGHT TO BE SOME END OF THE GRANT BOTTOM LINE NOT THAT WE DIDN'T PAY SOMEBODY ELSE TO DO WHAT YOU WERE SUPPOSED TO DO BUT THAT YOU DID. THE POINT FOR ME IS SOME OF -- THERE ARE GRANTING AGENCIES YOU WRITE DOWN YOUR MILESTONES AND YOU DON'T GET THE MONEY UNTIL YOU MET THOSE MILESTONES. I HEAR YOU ONE OTHER ISSUE IS THE HUN HASN'T HAD THE FINAL PROGRESS REPORT LIKE OTHERS HAVE HAD. THERE IS A NEW MY UNDERSTANDING MOVE TO HAVE A PROJECT OUTCOMES SECTION. IN THAT FINAL REPORT THAT WE HAVE NEVER SECURED BEFORE. THAT IS ONE PLACE IN MY MIND IS A PLACE TO AT LEAST PROVIDE SOME INFORMATION ABOUT WHAT YOU FOUND OR DIDN'T FIND. WE HEAR YOU THAT YOU -- TO ELICIT THIS. WE HEAR YOU. GREAT. MARSHA. >> I WANT TO OFFER A POTENTIAL SOURCE OF INFORMATION ON THESE BIG DATA SETS. SO MARK COLLIN YOU MET DIRECTOR OF CENTER OF POPULATION HEALTH SCIENCES AT STANFORD, HAS GONE THROUGH INCREDIBLE EFFORT TO GET EVERY DATA SET HE CAN. SO HE KNOWS THE RULES AND I'M SURE THAT HE WOULD BE HAPPY TO HELP YOU FIGURE THAT OUT. AND BIG DATA IS BIG EVERYWHERE BUT STANFORD CREATED A NEW DEPARTMENT OF BIG DATA BECAUSE THEY THINK IT'S IMPORTANT STUFF. TRYING TO GET ALL THE XWAS DATA AS WE CAN AS WELL. >> FLOOR IS OPEN FOR ANY TOPIC. DR. BASURI. >> ONE LAST COMMENT BEFORE WE LEAVE THESE DATA SETS. WHAT WE OFTEN DO IS HAVE A POST DOC OR GRADUATE STUDENT OR SOMEBODY WHO WANTS TO TAKE THE TIME TO LEARN THE DATA SET, I DON'T WANT TO DISCOURAGE ANYBODY BUT IT'S WORK TO LEARN THE DATA SET. THERE'S THOUSANDS OF VARIABLES AND THERE ARE ALL SORTS OF ISSUES SO I ENCOURAGE YOU TO GET GET THE DATA SETS BUT YOU HAVE TO PLAN AHEAD WHO GET TO KNOW THE DATA LIKE BACK OF THEIR HAND SO THEY CAN REALLY UNDERSTAND HOW TO USE IT EFFECTIVELY AND FINALLY WITH REGARD TO THE POINT YOU ARE MAKING ABOUT THE FINAL PROGRESS REPORT AND POTENTIAL FOR THAT, THE WAYs BEEN HANDLED IN THE PAST IS THE SENSE THAT IF YOU DON'T PUBLISH THIS, WHEN YOU COME BACK FOR RENEWAL, YOU WON'T BE SUCCESSFUL BUT I DON'T THINK PEOPLE FOLLOWED UP ON THAT. THAT'S WHERE A FINAL PROGRESS REPORT ASKING THAT QUESTION THAT WOULD BE LINKED TO RENEWAL WOULD BE GREAT. >> THERE'S ALSO IN 21st CENTURY CURES IF YOU DO NOT REPORT APPLICABLE CLINICAL TRIALS RESULTS IN CD.GOV, THE NIH DIRECTOR HAS THE AUTHORITY TO WITHHOLD FUNDING TO THE GRANTEE WHICH IS THE ORGANIZATION NOT THE INDIVIDUAL, BUILT INTO 28%. OUR HOPE IS ALL PROVISIONS ENCOURAGE PEOPLE TO BE DOING WHAT THEY ARE SUPPOSED TO BE DOING. >> THERE'S FOLKS WHO HAVEN'T MADE ANY COMMENTS, I DON'T WANT TO CALL ON YOU BUT WANT TO MAKE SURE YOU HAVE TIME THE MAKE COMMENTS, GENERAL THINGS YOU HEARD THAT YOU WANTED TO GIVE US FEEDBACK ON OR ANYTHING THAT YOU MIGHT WANT TO SEE FOR EXAMPLE AT A FUTURE MEETING. SO I WILL CALL ON HERE BECAUSE I KNOW HIM WELL ENOUGH TO CALL ON HIM, DR. DEVRIES, ARE THERE ANY TOPICS THAT YOU MIGHT WANT TO SEE IN A FUTURE MEETING? Z >> SO WE HAVE DISCUSSED THIS COUPLE OF TIMES RELATED TO WHAT MARSHA SAID, VERY IMPORTANT, THIS WHOLE FACTOR GENDER, SEEING FROM A SEX LENS, I PERSONALLY THINK YOU HAVE GENDER START SEX CREATING GETTING YOU INTO SOME SORT OF SHAPE THAT SOCIETY PERCEIVES YOU AS MALE OR FEMALE OR SOMEWHERE IN THAT SPECTRUM. SO YOU MENTIONEDDED THIS IS A PROBLEM OF THE ANIMAL RESEARCH AND I WOULD AGREE WITH YOU, WE DO SUCH THINGS LIKE MALES AN FEMALES AT DIFFERENT RATE, EXTREMELY IMPORTANT RESEARCH F YOU GET DATA OF SUBSTANCE ABUSE DISORDERS, OR ANY OTHER VARIABLE THAT REQUIRES INTERACTION BETWEEN PERSON GETTING THE DATA AND PERSON GIVING DATA, THEN START PLAYING A ROLE. IT IS NOT SOMETHING THAT I HAVE EVER OFFICIALLY SEEN IN NIH DOCUMENTS WE HAVE TO IN ADDITION TO SABV -- SEX AS BIOLOGICAL VARIABLE HAVE TO PAY ATTENTION TO THIS. AND WE DISCAN YOUD POSSIBILITY OF HAVING A CALL FOR RESEARCH PROJECTS IN THIS AREA. THAT ARE GOING TO BE REVIEWED BY PEOPLE THAT KNOW WHAT IT TAKES TO LOOK AT GENDER SPECIFIC LENS. I EXPRESS MY HOPE THIS IS SOMETHING WE CAN TAKE SERIOUSLY. >> THANK YOU FOR THAT. WE DO HEAR YOU. FROM DR. ROBINS, GOING THROUGH THE ROW TO SEE IF THERE'S INPUT IDEAS OR COMMENTS OF THINGS YOU LIKE TO IN THE MEETING OR INPUT TO PROVIDE. >> FIRST THIS IS MY FIRST MEETING, IT WAS WONDERFUL AND I WANTED TO TALK ABOUT THE CROSS ROADS BETWEEN GENDER RACE AND ETHNICITY. IF I USE THE EXAMPLE OF A PERSON WHO TALKED ABOUT THE OPIOID CRISIS, WE HAVE STUDIES WHERE WE KNOW THAT IN CERTAIN SETTINGS THE PRESCRIPTION PATTERNSES FOR PEOPLE WHO ARE PEOPLE OF COLOR ARE DIFFERENT FOR PRESCRIPTION PATTERNS OF OTHER PEOPLE. WHAT WE SAW TODAY IN THE DATA WAS THE DIFFERENCE BETWEEN OPIOID ADDICTION IN MEN AND IN WOMEN. I'M ASKING NOW ABOUT WOMEN OF COLOR VERSUS OTHER WOMEN. IF PRESCRIBING PATTERNS HAS SOME IMPACT ON ADDICTION AND PRESCRIBING PATTERNS ARE LESS FOR PEOPLE OF COLOR, WHAT IS IS THE IMPACT OF THAT WHEN IT COMES TO NOW WOMEN OF COLOR? WE CAN TAKE THAT AND SPREAD OUT TO SOME OF THE OTHER PRESENTATIONS THAT WE HAVE HAD AS WELL SO IT'S ANOTHER LAYER TO STRATIFY ON. IF I THINK FUTURE DIRECTIONS, WE HAVE MEN VERSUS WOMEN, GENDER VERSUS SEX BUT ALSO RACE AND ETHNICITY QUESTION WHICH FOR US WE'RE SEPARATING THAT, WE ARE GOING THIS RACE, THAT RACE THEN GENDER SEX BUT MAYBE SOME OF THOSE HAVE TO BE COMBINED AND UNSTEAD OF THAT MANAGE BEING IN THE FUTURE -- SOMETHING IN THE FUTURE WE CAN TAKE THAT TOGETHER. >> THAT'S EXTREMELY IMPORTANT TO US. THE INTERSECTION OF SEX GENDER RACE ETHNICITY, AND SIMULTANEOUS ASSESSMENT OF EACH ADS WELL AS THE CON -- AS WELL AS THE CONTEXT. I WILL ASK DR. CARHILL TO MAKE ONE OR TWO STATEMENTS ABOUT THE U-3 PROGRAM AND HOW WE THINK ABOUT THOSE ISSUES MOVING FORWARD. WOULD YOU MAKE A FEW THEN SABRA I'LL LET YOU RESPOND. >> THANK YOU, DR. CLAYTON. ONE OF THE PROGRAMS THAT WE HAVE AT ORWH IS A U 3 PROGRAM UNDERSTUDIED UNDER-REPRESENTED AND UNDERREPORTED WOMEN. THE NICE ASPECT OF THIS PROGRAM, ADMINISTRATIVE SUPPLEMENT PROGRAM BUT IT'S GROWING SO WE INTENTIONALLY LOOK AT WOMEN WHO ARE NOT ONLY UNDERSTUDIED AND UNDER-REPRESENTED IN BIOMEDICAL RESEARCH BUT OFTEN HAVE MULTIPLE OTHER FACTORS THAT ARE CO-OCCURRING THIS FOCUSES ON INTERDISCIPLINARY APPROACH, YOU HOPE TO BRING TO TABLE THE DISCIPLINES NOT ROUTINELY REPRESENTED IN BIOMEDICAL RESEARCH. FOR EXAMPLE MIGHT BE INTERESTED IN LOOKING AT THE INTERSECTION OF BIOLOGIC SEX AND RACE, BUT IT HAS -- CAN'T BE DONE WITHOUT THE CONTEXTUAL OR SOCIO CULTURAL INFLUENCE SUCH AS AN INDIVIDUAL WHO EXPERIENCED DISPLACEMENT OR HAS EXPERIENCED INTIMATE PARTNER VIOLENCE. I GIVE AN EXAMPLE OF KIM BLANKENSHIP'S PAPER LOOKING AT THE RATE OF SEX AND TRANSMITTED INFECTION IN RENTAL EVICTIONS WHICH ON THE SURFACE LOOKS HERE BUT ACTUALLY ARE HERE AND WHEN YOU ADD THAT VERY OFTEN THOSE EVICTEES ARE WOMEN SINGLE HEAD OF HOUSEHOLDS AND YOU LOOK IN THE UNITED STATES WHERE IN A TIME WE HAVEN'T HAD BLACK WOMEN HEAD OF HOUSE MOLDS EXCEPT SLAVERY SO THAT BRINGS TO THE LENS A WAY OF LOOK AT THINGS NOT ONLY BIOLOGIC FOR EXAMPLE THE PERK STUDIES WE CAN START TO LOOK AT THE RESULTS OF BEING ABLE THE GET PRE-EXPOSURE PROPHYLAXIS AND PHARMACO PHARMACOKINETICS TO THE BUILT IMPACT IN HISPANIC WOMEN WHETHER THEY DO RESOLVE POSTPARTUM DEPRESSION AND WHAT EXTENT S THESE ARE PROJECTS WE HAVE COMING IN, I WAS CHECKING BECAUSE MY PHONE WAS PINGING SO MUCH I WAS AFRAID I WAS DISTURBING THE MEETING. DEAD LINE CLOSED MONDAY AND WE HAVE INVESTIGATORS THAT SENT THEIR PROJECTS AND ASKING ME DID YOU GET IT BECAUSE THEY'RE EXCITED, WE'RE STARTING TO NOW FOR EXAMPLE TAKE A LOOK AT AUTISM IN YOUNG GIRLS OF COLOR IN RURAL AREAS WHO DON'T HAVE ACCESS TO OTHER TYPES OF TREATMENT. SO WE TAKE THAT VERY SERIOUSLY. >> DID YOU WANT TO COMMENT ON THIS ISSUE? >> MAYBE JUST TO LET YOU KNOW THAT I THINK THERE ARE MANY OF US WHO ARE INTERESTED AND STUDYING THIS AT THE SCORE AT JOHNS HOPKINS WHICH I'M PI SEX AGE DIFFERENCES I BELIEVE IMMUNITY AND INFLUENZA. THE DIRECTOR OF WHAT WE TERMED SEX GENDER ANALYSIS CORE IS ROSE MARY MORGAN, A JUNIOR INVESTIGATOR AND IN INTERNATIONAL HEALTH, SHE'S DONE INCREDIBLE WORK LOOKING AT INTERSECT OF RACE ETHNICITY IN GENDER AND HAS STATISTICAL WAYS OF CREATING COMPOSITE SCORES BECAUSE THAT'S HER FRUSTRATION AS WELL WE TREAT AS SEPARATE YOU TAKE A DATA SET REGARDLESS OF RACE ETHNICITY WHAT DO MALES AND FEMALES LOOK LIKE, REGARDLESS WHETHER MALE OR FEMALE WHAT DO THE DATA LOOK LIKE BROKEN BY RACE OR ETHNICITY. SHE CREATES A COMPOS AT THIS TIME SCORE BECAUSE SHE BELIEVES BEING BLACK AND A WOMAN THAT IS ITS OWN VALUE. THEN YOU HAVE BEING BLACK AND BEING MALE. SO I'M SHARING THIS BECAUSE WE NOW HAVE A CORE AND HER GOAL BASICALLY SO TO HELP US MAKE SENSE OUR DATA BUT SHE COULD BECOME RESOURCE AND CORE COULD BECOME A BROADER RESEARCH OUTSIDE JOHNS HOPKINS TO EDUCATE HOW YOU CAN STATISTICALLY DO THIS CORRECTLY. >> THANKS FOR THE INPUT, I DID MEET HER AT WOMEN LAUNCH. GREAT TO MEET HER. ROGER, YOU? >> IT'S BEEN A GREAT MEETING. ONE THING I WAS THINKING ABOUT IN TERMS OF WORKPLACE CLIMATE ISSUES AND CAREER DEVELOPMENT FOR WOMEN IN PARTICULAR, WE HAVE VISIT OUR INSTITUTION FROM BRAD JOHNSON WHO WROTE THE BOOK ATHENA RIDES, HOW AND WHY MEN SHOULD MENTOR WOMEN AND ONE OF THE WHYS THERE AREN'T ENOUGH WOMEN TO HAD BEENTOR WOMEN IN SENIOR LEVELS -- TO MENTOR WOMEN AT SENIOR LEVELS AND SOME OF THE WOMEN WHEN I SUGGESTED HIM THE IDEA MEN SHOULD MENTOR WOMEN, BUT IT WAS IMPACTFUL LEADERSHIP AT OUR INSTITUTION WAS THERE, BECAUSE ONE OF THE THINGS THAT SEEMS TO BE HAPPENING IS MEN ARE ARE STEPPING BECOME FOR A VARIETY OF REASONS IN THE CURRENT CLIMATE, MENTOR DEVELOPMENT OF WOMEN, THEY NEED TO BE MENTORED CORRECTLY AND SAFELY SO HE'S AN OUTSTANDING SPEAKER, I RECOMMEND HIM TO ALL OF YOU, IT MIGHT BE WORTH CONSIDERING FOR OUR GROUP AT SOME POINT. FROM >> ANY ADDITIONAL THINGS? DOWN THE ROW. NOELLE. >> I THINK WE SHOULD REVISIT THE THE EDITOR ISSUE. THERE'S MORE AMEN -- APPENDICES IN THE CLOUD NOW. THERE'S A FEW MORE WOMEN, NOT THAT THAT ALWAYS MATTERS, FEMALE EDITORS, LAST TIME WE TALK ABOUT IT THREE OR FOUR YEARS, LANSETT ARTICLE CAME OUT I THINK WE COULD POTENTIALLY GET LEADERSHIP GROUP TO LEAD BY EXAMPLE WE SHOULD TRY AGAIN. >> ONE OF THE CONCERNS ALWAYS HISTORICALLY IS THAT WE DON'T HAVE ENOUGH SPACE, IT'S PAGE LIMITS. NOW EVERYTHING IS ONLINE, THERE IS MORE SPACE, THEY'RE PUTTING HUGE DATA BASES AS LINK ON TO PAPERS SO THAT WAS A PROFOUND BARRIER IN THOSE PREVIOUS ROUNDS AS JOURNAL EDITORS, IT'S A NEW WORLD NOW. THAT IS ONE WAY TO BREAK THROUGH ONE LOG JAM AND FIGURE HOW TO MAKE THEM TRACK IT. >> MARSHA ANYTHING TO ADD? >> I WOULD LIKE TO CONTINUE THE INTERSECTIONAL LENS DISCUSSION, MAKE THE POINT LIFE SPAN WAS EMPHASIZED AND THAT IS GREAT BUT I THINK THAT NEEDS TO ALWAYS BE IN THERE TOO, AGE AND REPRODUCTIVE FACTORS BECAUSE THESE ARE IMPORTANT FOR WOMEN BUT GOING TO THE SOCIAL STRUCTURE WHEN YOU START TO LOOK AT AGE PEOPLE WANT TO MAKE THE IDEA NOW I'M DOING MOSTLY AGE RESEARCH SEX DIFFERENCES EXIST LIKE SOMETHING LIKE SEXUAL FUNCTION AND THEY START TO SHOW DATA ON MEN VERSUS WOMEN BUT FORGET THE FACT WOMEN ARE LIVING ALONE AND THEY ARE WIDOWS AND MEN WEREN'T WHEN SO WE'RE NOT TAKING INTO ACCOUNT SOCIAL FACTORS AND IF YOU START TO TALK ABOUT A SINGLE MOTHER RAISING FAMILIES IN ONE RACE GROUP THAT'S VERY DIFFERENT FROM OTHER RACE GROUPS, ALL THESE THINGS HAVE TO BE BROUGHT TO MIND, THIS IS THE GENDER ISSUE BROUGHT TO MIND BEFORE WE START MAKING BIOLOGICAL STATEMENTS ABOUT THAT. IN PARTICULAR WHEN PEOPLE SAY MEN VERSUS WOMEN, A REPRODUCTIVE AGE WOMAN IS DIFFERENT FROM A POST MENOPAUSAL WOMAN THAT WE HAVE TO BE CAREFUL ABOUT DICHOTOMY AND REALIZE IT IS INTERSECTIONAL VERY COMPLEX AND WE ARE ON THE FRONTIER HERE. >> THIS WAS A WONDERFUL MEETING. STILL IS WONDERFUL, I THINK ONE OF THE THINGS WE HAVEN'T HAD A MOMENT TO TALK ABOUT TODAY IS HOW THIS SITUATION OF WOMEN FOR WOMEN AND WHAT I'M REFERRING TO IS WOMEN ARE STILL BEING BATTERED. THEY'RE STILL EXPERIENCING INTIMATE PARTNER VIOLENCE AND ALSO STILL DENIGRATING THEMSELVES. AND I THINK WE HAVE OPPORTUNITIES WITH SOCIAL MEDIA TO DO GOOD, SEE HOW IT DOES BAD THAT'S IN THE MEDIA A LOT. BUT I THINK THERE ARE REALLY IMPORTANT POSITIVE USES OF FACEBOOK AND SOCIAL MEDIA AND SOCIAL MEDIA YET TO COME, THAT WE NEED TO KEEP OUR EYE, KNOW ORWH HAS A VERY GOOD COMMUNICATION DEPARTMENT SO HAPPY TO HEAR THAT. OUR OUTREACH REACH WOMEN AND MEN AT THEIR HOMES ON THEIR PHONES AND CONTINUING THE PURSUIT OF TRANSLATIONAL WORK DISSEMINATING EFFICACIOUS INTERVENTIONS AND MAKING THEM APPLICABLE TO SMART PHONE USE AND MOBILE EXPLORING THE CAPACITY FOR MOBILE COMMUNICATION AND FOR POSITIVE USE OF SOCIAL MEDIA THAT PROMOTE WOMEN'S HEALTH. >> THANK YOU RACHEL. CAN YOU SHARE THE PROPORTION YOU SHARE WITH ME YESTERDAY? THE PROPORTION OF PARTICIPATES IN YOUR STUDY RECRUITED THROUGH FACEBOOK STORIES THE VIGNETTES VERSUS JUST ROUTINE OUTREACH? >> WE STARTED OUT -- IT'S AN RO1 MECHANISM, WE STARTED OUT HOPING TO GET ROUGHLY EQUAL SAMPLE SIZES, I'M IN THE BOSTON AREA, IT GETS COLD, GETS VERY HOT. SO WHAT WE DID IS RECRUITED ON FACEBOOK AND USING SAME METHODS RUSSIANS ARE BEING ACCUSED OF, WE USED AFFINITY TERMS, WE USE ZIP CODES AND IN TERMS WE ICE WOMEN 18-29 PREDOMINANTLY BLACK WOMEN WERE WATCHING HOUSEWIVES OF ATLANTA THAT'S AN EXAMPLE, MANY OTHER EXAMPLES, IT IS A STUDY TARGETING ZIP CODES WITH HIGH INCIDENCE, HIGH PREVALENCE OF HIV AIDS, IT'S AN HIV AIDS PREVENTION STUDY WE REACHED 5,000 WOMEN, MORE THAN THAT. WE REACHED MANY MORE THAN THAT BUT 5,000 TOOK CONSENT AND SCREENING SURVEY. OF THOSE 2400 WERE HIGH RISK. SO OUR STUDY INCLUDED 800 WOMEN WHO COMPLETED THE INTERVENTION WHO CONSENTED AND TOOK THE WHOLE INTERVENTION. >> CONGRATULATIONS ON THAT. DR. REAGAN STEINER. >> I'M STRUCK BY DEPTH OF INFORMATION WE GAIN AT THESE MEETINGS. AND I'M STRUCK THAT WOMEN'S HEALTH IS STILL HAS SUCH A LONG WAY TO GO. SEX DIFFERENCES RESEARCH BUT IT'S REALLY GOOD THAT OFFICE FOCUS ON THIS, ALL OF US WORKING TOGETHER ON IT. >> DR. GREGORY. I ENJOYED THE MEANING IF FACT THAT YOU ADDED REFERENCES TO THE SLIDE AND THE OPPORTUNITY TO FOLLOW-UP BECAUSE THERE WERE SEVERAL THINGS YOU MENTION TODAY THAT I WISH I HAD KNOWN ABOUT SINCE I DIDN'T THE FACT IT'S ARCHIVED AND I CAN FOLLOW-UP IS MOST APPRECIATED. DR. PAGE. >> SO JANINE I WOULD LIKE TO GO BACK TO YOUR PRESENTATION THIS MORNING. ONE SLIDE YOU BRIEFLY PROVIDED THE OVERVIEW OF THE ORWH FUNDING HISTORY. WE DIDN'T LINGER ON THAT TOO LONG BUT IT'S -- I KEEP THINKING ABOUT IT ACROSS THE COURSE OF THIS EXCELLENT MEETING. SO IT LOOKS A LITTLE BIT LIKE -- IN THE SOUTHWEST. THERE WAS A STEEP KLINE UNTIL 2002 AND THREE THEN WE SIMPLY HAD THE EROSION OF INNATION ON THAT SEEMINGLY FLAT TOP WHICH IS ACTUALLY BEEN, SO MY SENSE IS THAT OUR AWARENESS OF THE NEED DOUBLING DOWN ON WOMEN'S HEALTH AND UPON SEX AS A BIOLOGICAL VARIABLE INCREASED SO MUCH IN THOSE 16 YEARS. THE RESOURCES, WE NEED TO RECOGNIZE AS YOU SIT AROUND THIS TABLE RESOURCES AT THE NIH LEVEL TO ADDRESS THESE QUESTIONS, IN FACT HAVE IN FACT BEEN SLIPPING AT LEAST THE PURCHASING POWER. OBVIOUSLY WE ARE NOT LOBBYING GROUP BUT AT LEAST WE CAN SAY THESE THINGS THAT I NOW YOU CAN'T QUITE SAY. SO I THOUGHT IT WAS IMPORTANT TO SAY I'M DISAPPOINTED, GIVEN THE QUALITY OF THE WORK OF YOUR OFFICE AND THE IMPORTANCE OF QUESTIONS, I'M DISAPPOINTED THAT WE HAVE NOT ACTUALLY MADE HEADWAY IN TERMS OF PUTTING MONEY WHERE OUR MOUTHS ARE. >> I APPRECIATE THAT, DAVID, ONE THING I CAN SAY TO THAT IS REALLY TEAM ORWH HAS DONE A FANTASTIC JOB MAKING LEVERAGING THE RESOURCES THAT WE HAVE AND MAKING TOUGH DECISIONS. LITERALLY IF WE WANT TO DO SOMETHING DIFFERENT WHAT ARE THINGS WE CONSIDER STOPPING DOING, BECAUSE THAT'S REALLY THE ONLY WAY THAT THIS COULD HAPPEN. I APPRECIATE IT. DR. MCGREGOR. >> I WANT TO SAY HOW THRILLED I AM TO BE HERE THIS IS FUN FOR ME TO TALK ABOUT THIS STUFF, IT HELPS ME SHARPEN ARGUMENTS WHEN I GO BACK OUT INTO MY OWN WORLD. AND FIGHT THE FIGHT. JUST SOMETHING ON DR. STEFANIK HAS BEEN SAYING WHICH IS LIFE ACROSS THE LIFE SPAN, THAT'S ALSO REALLY IMPORTANT NOT JUST FOR THE CULTURAL GENDER PIECE BUT ALSO FOR THE BIOLOGICAL SEX PIECE, THERE'S LOTS OF DATA OUT THERE ABOUT MEDICATIONS THAT HAVE DIFFERENT SERUM CONCENTRATIONS AND DIFFERENT SIDE EFFECTS DEPENDING ON MENSTRUAL CYCLE, AND I THINK THAT'S SOMETHING THAT NEEDS TO BE STUDIED AT A VERY MINIMUM POST MENOPAUSAL PREP MENOPAUSAL BUT I WOULD LIKE TO SEE STUDIES IN THE FUTURE NOT ONLY HAVE PIE LOGICAL SEX AND GENDER BUT ALSO STATUS OF WOMEN'S ESTROGEN. >> THANK YOU. I COMMEND YOU TO PAGE 7 OF THE STRATEGIC PLAN. MULTI-DIMENSIONAL FRAMEWORK YOU WORKED ON. IT INCORPORATES INTERNAL FACTORS, EXTERNAL FACTORS INCLUDING GENDER AND OTHER SOCIAL DETERMINANTS OF HEALTH, ENVIRONMENTAL TOGETHERICS EXPOSURE -- TOXIC EXPOSURE, STRESS EXPOSURE WHICH IS VERY DIFFERENT AND ALL IN THE CONTEXT OF THE LIFE FORCE. I WANT TO ACKNOWLEDGE DR. CHAI WHO IS THE SAT WITH ME THE FIRST TIME WE DREW THIS -- THE FIRST VERSION OF THIS ON A PIECE OF PAPER, IN MY OFFICE PROBABLY AFTER SIX O'CLOCK OR SOMETHING WHEN PEOPLE WERE SAYING WHY ARE YOU GUYS NOT GOING ONLY. SO THANK YOU BUT I WANT TO HIGHLIGHT THAT FOR YOU BECAUSE ALMOST EVERY COMMENT HAS A PLACE HERE. THIS IS OUR GUIDING NORTH STAR WHERE WE ARE GOING. SO WE APPRECIATE YOUR HELP FINDING WAYS TO GET THIS VIEW OF HEALTH OF WOMEN ACROSS THE LIFE FORCE OUT IN THE ORGANIZATIONS INSTITUTIONS AND YOUR NETWORKS. >> TO BE FAIR TO YOUR COLLEAGUES. DON'T FORGET. DR. MASURI. >> TWO THINGS, I HAVE BEEN DOING THIS A LONG TIME LIKE A NUMBER OF PEOPLE IN THIS ROOM. I HAVE SEEN CHANGE OVER TIME. I THINK IN THE LAST FEW YEARS I HAVE SEEN INFLECTION POINT WHERE THE RATE OF CHANGE IS INCREASING IN A POSITIVE DIRECTION. WHEN I THINK ABOUT THAT, I THOUGHT ABOUT THAT A LOT AND REFLECTED ON THAT? LARGE MEASURE I HAVE SEEN THAT CHANGE BECAUSE OF THE CHANGE IN REQUIREMENTS OF THE NIH WITH REGARD TO SABV. I REALLY THINK IT'S IMPORTANT TO ACKNOWLEDGE THE WORK OF THIS OFFICE BECAUSE THIS OFFICE DID THAT IN MY VIEW AND IT IS CHANGED SCIENCE IN A BIG WAY. EVERYBODY WHO WORKED ON THAT DESERVES ENORMOUS AMOUNT OF CREDIT FOR DOING THAT. FROM I SO APPRECIATE THAT. THE SECOND THING I WANT TO SAY IT'S BEEN A PRIVILEGE TO SERVE ON THIS COMMITTEE, IT'S GREAT FUN, I ALWAYS LEARN SOMETHING. NO MATTER WHAT IS BEING PRESENTED THERE'S NEW INFORMATION THAT I CAN TAKE BACK AND USE AND I REALLY DO APPRECIATE THAT. IN MY OWN INSTITUTION WE'RE DEALING WITH MANY ISSUES THAT WE TALKED ABOUT TODAY INCLUDING ISSUES OF HARASSMENT AND CLIMATE AND OTHER THINGS, THE WOMEN HAVE ORGANIZED IN A WAY THAT I THINK HAS BEEN VERY POSITIVE PARTICULARLY SENIOR FACULTY WHO ARE WOMEN AND WE REALLY DO HAVE A RADICAL UNDERBELLY, IT'S TERRIFIC. SO WE'RE ALL ASKED TO MAKE COMMENTS ABOUT WHAT DO YOU SAY TO THEJ GENERATION OF INDIVIDUALS. ONE OF AMONG THE THINGS THAT I SAID WAS THAT STICK TOGETHER. I KNOW YOU WILL. DON'T GIVE UP. I KNOW YOU WON'T. SO I FEEL THAT WAY ABOUT THIS OFFICE, IT'S EXEMPLIFIES. I THANK YOU. >> THANK YOU FOR THOSE REALLY KIND WORDS. WE APPRECIATE IT. DR. WOOD AND MCCULLOUGH IS ON THE PHONE, BACK TO DR. STEFANIK. >> I WANT TO REITERATE A COUPLE OF O POINTS AND TAKE IT BACK TO BASICS, HAVING THE DATA IN AN INTERSECTIONAL WAY IS NOT -- IS SOMETHING WE'LL TALK ABOUT FOR A LONG TIME BUT IT'S HARD TO GET. EVEN IF IT'S JUST A BASIC PREVALENCE DATA OR WHO IS IN A STUDY DATA. FROM OR ALL OF THAT. SO ALWAYS SPEAKING ABOUT THAT IN TERMS OF STARTING WITH AGE RACE ETHNICITY AND THROW IN GEOGRAPHY AND SEX, ALL AT ONCE SOMEHOW BEING ABLE TO DO THAT VISUALIZE THAT SO WE CAN SHARE THAT INFORMATION WITH OTHER PEOPLE. IT'S HELPFUL TO DO THAT. SECONDLY THE BACK TO BASICS WAS -- WE GO BACK TO WAY BACK WHEN, WE HAD THE REQUIREMENTS ON CLINICAL TRIALS HAVING INCLUSION TO DO A STATISTICALLY VALID ANALYSIS AND ALL THAT, AND MOVING FORWARD TO NOW LOOKING AT INCLUSION IF YOU WILL AROUND VERTEBRATE ANIMALS FOR SABV, WE NEED MORE INFORMATION ON WHAT'S HAPPENING IN OTHER PHASES OTHER THAN PHASE 3,ING THE SOMETHING TALK WITH CAROLYN ABOUT BUT EARLIER PHASES WHERE INCLUSION IS REQUIRED BUT WE'RE NOT GOING TO HAVE SAME OUTCOMES LIKE CLINICAL CLINICALTRIALS.GOV WHICH IS, THAT'S A GREAT NEW RULE REQUIREMENT THAT WILL ACTUALLY GET OUTCOME DATA. THAT'S LIMITED ONLY TO PHASE 3 CLINICAL TRIALS, THAT ARE PART OF THE FDA TRACK KIND OF THING. HAVING SOME OTHER WAY TO GET THE REST OF THE CLINICAL STUDIES ALL PHASES HOW YOU WANT TO LABEL THEM WOULD BE I THINK WOULD BE HELPFUL FOR US TO KNOW BECAUSE WE HAVE GOT A LOT OF PROGRESS IN PHASE 3. WHEN YOU LOOK, THAT'S ALWAYS BEEN THE CASE. THERE'S ALWAYS BEEN MUCH BETTER REPRESENTATION IN PHASE 3 THAN IN PHASE 1 AND 2, WHATEVER. REALLY HELPFUL. THANK YOU. LOUISE, ARE YOU ON? >> YES. I'M SO SORRY THAT I COULDN'T BE THERE THIS TIME. I ENJOY THE DISCUSSION AND HIGH POINTS BROUGHT UP. I WOULD PUT IN A PLUG FOR THE GWAS AND THINK TANK ONLY BECAUSE WE DID THAT A FEW MONTHS AGO AND I WANT TO HOPE MOMENTUM CONTINUES WITH THAT. BECAUSE I THINK THAT'S AN IMPORTANT THING BOTH IN PRE-CLINICAL STUDIES WHICH OFTEN DO RNA SEQ ONLY IN ONE ANIMAL OFTEN A YOUNG ANIMAL SOMETIMES AVOID FEMALES BECAUSE OFs ROWS AND THIS IS ALSO PERVASIVE IN THE GWAS STUDIES, THE RECORDERS NOT PAYING ATTENTION TO THINGS ON THE SEX CHROMOSOME OR AUTOSOME INFLUENCED BY SEX CHROMOSOME. THE PROBLEM IS COME UP IS TECHNICAL AND HOPEFULLY GETTING SOME BUY IN FROM PEOPLE DOING THINGS LIKE BIOINFORMATICS CAN HELP US, I WAS HOPING WE CAN KEEP THAT TOPIC ON THE FOREFRONT BECAUSE IT'S IMPORTANT. >> THANK YOU, LOUISE, WE HEAR YOU. WE ARE WORKING ON IT AND HOPEFULLY WE WILL HAVE MORE INFORMATION TO SHARE WITH Y'ALL SOON BUT EVERYONE WILL BE -- AVAILABLE. >> GREAT. >> DR. MCCULLOUGH, DR. HUNTER WANTS TO MAKE A COMMENT TO YOU. >> I NEGLECTED TO MENTION YOU WERE A CO-CHAIR FOR THAT -- >> NO WORRIES ABOUT THAT. I HOPE WE CAN KEEP IT GOING BECAUSE IT'S HARD AND LIKE SABV, IT'S HARD. IT'S HARD TO DESIGN YOUR EXPERIMENTS, AND I THINK THE ONE THING MENTIONED A LITTLE BIT, WE HAVE TO BE CAUTIOUS ABOUT SHOVING PEOPLE SAYING YOU HAVE TO DO THIS YOU WON'T GET PUBLISHED WON'T GET YOUR GRANTS, ONLY BECAUSE I'M STARTING TO SEE BACKLASH ABOUT STUFF ISN'T IN A BIOLOGICAL VARIABLE AND IT ISN'T IMPORTANT. I THINK WE WILL WASTE TIME DEBATING THOSE POINTS AND SOMETIMES I JUST THINK WE HAVE TO BE VERY I DON'T KNOW NOT THE WORD CAUTIOUS BUT SENSITIVE TO SOME OF THE HESITATION TO SCIENTISTS AND CLINICIANS FEEL. I'M NOT SAYING IT'S RIGHT BUT I JUST WOULDN'T WANT TO SEE A LOT OF ARGUMENTATIVE STUFF SAYING IT'S NOT IMPORTANT WHEN WE KNOW IT IS. >> THANKS, APPRECIATE THAT. STAY TUNED FOR MORE. DR. STEFANIK. >> I DIDN'T -- SOUNDS LIKE EVERYONE IS MAKE CONCLUDING REMARKS AND I WASN'T DOING THIS BEFORE SO THIS HAS TO BE A PS. FROM WHEN YOU WERE TALKING ABOUT THIS MODEL BECAUSE THIS MODEL IS I HAVE SEEN VERSIONS OF THIS MODEL, THE IN UTERO, I WANT TO MAKE A POINT THAT I THINK THAT THE ANIMAL RESEARCHERS COULD DO A HUGE AMOUNT WITHOUT HAVING TO INCREASE ANIMAL NUMBERS BY DOING PLACENTAL RESEARCH BECAUSE THE PLACENTA IN THE ANIMAL, THE BEAUTY OF THEM IS THEY HAVE THE SAME MATERNAL ENVIRONMENT BUT YOU HAVE MALES AND FEMALES IN THAT SAME MATERNAL ENVIRONMENT AND THE XX XY UTERUS IS A PHENOMENAL PLACE -- THING TO STUDY, PARTICULARLY FOR NEURAL DEVELOPMENT SO I FEEL UNDERSTANDING MORE ANIMAL RESEARCH IS THOUGHT ABOUT WHICH I DON'T THINK THEY THINK ABOUT THE FACT THAT PLACENTA IS XX AND XY, I FEEL LIKE THERE'S A WHOLE OPPORTUNITY TO FIT INTO THIS MODEL IF I LET MORE PEOPLE KNOW ABOUT THAT. >> NICHD IS FUNDING HUMAN PLACENTA PROJECT. I DON'T KNOW IF IT'S HUMAN, IT'S THE PLACENTA PROJECT SO THAT MIGHT BE A TOPIC THAT Y'ALL MIGHT WANT TO HEAR IN THE FUTURE. >> THE DISADVANTAGE TO HUMAN RESEARCH IS THAT YOU GENERALLY ONLY HAVE ONE OR THE OTHER, WRITTEN WITHEN A MALL STUDIES YOU HAVE FOUR OF EACH. >> (INDISCERNIBLE) WAS NEXT. >> IF YOU FIGURE OUT HOW TO DO THIS CLEARINGHOUSE AND PUBLISH SEX STRATIFIED ANALYSIS IN THE WEB, YOU CAN PUT THAT IN THE FOA AND THEN BELIEVE AS SOON AS THEY SEE THAT, THEY'LL PUBLISH IT. >> YOU WERE RIGHT. >> I WAS GOING TO SAY AT THE OSST MEETING IN MAY WE WILL HAVE AN ENTIRE SESSION DEDICATED TO PLACENTAL INFLUENCES TO THE DEVELOPMENT OF DIFFERENCES BETWEEN MALES AND FEMALES, GOING FROM IF HUMAN EPIDEMIOLOGICAL DATA ALL THE WAY TO ANIMAL STUDIES. >> SOUNDS EXCITING. SO WE HAVE A LITTLE BIT MORE TIME BUT I WANT TO MAKE SURE WE HAVE GIVEN YOU ALL THE OPPORTUNITY TO ASK ANY OTHER JUST QUESTIONS YOU MIGHT HAVE ABOUT ANY PROBLEMS YOU HEARD BEFORE, WE CERTAINLY CAN ADJOURN EARLY, NOT A PROBLEM. I WANT TO MAKE SURE EVERYONE HAD AN OPPORTUNITY TO ASK THEIR QUESTIONS. DR. PAGE. >> WE TALKED EARLIER ALSO ABOUT YOU PROVIDED A GOOD OVERVIEW OF INTERACTIONS WITH OTHER ICs AND SUCH SO I'M CURIOUS TO KNOW IF YOU CAN PROVIDE MORE COLOR COMMENTARY ON WHERE ACROSS THE NIH LANDSCAPE ARE THE STRONGEST CHAMPIONS YOUR STRONGst PARTNERS EMERGING SO WE MIGHT BE ABLE TO ENCOURAGE THEM IN SETTINGS OTHER THAN THIS, WHERE ARE THE MOST EXCITING SPROUTS? >> WHAT I THINK I CAN DO DAVID IS TALK A LITTLE BIT ABOUT THE RELATIONSHIPS WE HAVE BEEN BUILDING THROUGH THE CCRWH, THE NIH COORDINATING COMMITTEE FOR RESEARCH ON WOMEN'S HEALTH, 21 CENTURY CURES HAD LANGUAGE AROUND MEMBERSHIP SCCRWH, THERE WAS A PROVISION TO CHANGE THE IC REPRESENTATIVE, IC DIRECTOR OR DESIGNEE TO SENIOR LEVEL DESIGNEE, WHAT WE SEE IS RECONSTITUTION DR. COLLINS CAME TO RECHARGE THE GROUP AND RECONSTITUTION OF THAT GROUP AND THERE HAVE BEEN AS TYPICAL AT NIH SOME INSTITUTES CENTERS MORE ENGAGED THAN OTHERS. IN THE PAST WE FEATURED A COLLABORATION WITH NHLBI. I RECENTLY SPOKE AT THEIR COUNCIL, WITH NIGH TA, NIAA WE HAD INCREASE AND YOU SAW THE ICs WE CO-FUND WITH, THAT'S ONE SIGNAL, THOSE ARE INSTITUTES WILLING TO PUT THEIR MONEY WHERE THEIR MOUTH IS AND SUPPORT EFFORTS WE ARE ALSO DOING INTERESTING THINGS LIKE WORKING WITH NICHD IN A NEW WAY. DR. SAM ORGANIZED A GROUP OF MATERNAL MORTALITY AND MORBIDITY POINTS OF CONTACT WHERE WE ORGANIZE WITH NICHD AND OTHERS TO TALK WAYS WE CAN SYNERGISTICALLY WORK TOGETHER AROUND THAT ISSUE. SO IF THERE'S AN INTEREST IN HAVING MORE GRANULAR PICTURE OF SOME OF THE RELATIONSHIPS WITH THE ICs, THAT'S SOMETHING I CAN WORK INTO FUTURE DIRECTORS REPORTS AND. I THINK THE BUGGER ICs IS SURPRISING NCI HAD GREAT MEETING WITH THE INSTITUTE DIRECTOR, WE WILL BE HAVING MEETINGS WITH ALL THE INSTITUTE DIRECTOR, AGAIN ANOTHER REQUIREMENT OF 21st CENTURY CURES, THEY HAVE TO MEET WITH ME ONCE A YEAR NOW. AND THERE'S ALSO A NEW REQUIREMENT FOR THEM TO IN THEIR IC STRATEGIC PLANS ARTICULATE SPECIFICALLY HOW THEY ARE ADDRESSING WOMEN'S HEALTH. AND TO ARTICULATE METRICS FOR ADDRESSING WOMEN HEALTH SO THERE'S LOTS OF GOOD THINGS THAT ARE COMING THAT ARE TOUCH POINTS BUT NIDDK, NIDA, NIAAA, NHLBI AND NICHD HAVE BEEN SOME OF THE INSTITUTES THAT WE HAD IN THE PAST. THE MOST COLLABORATION WITH AND HAVE STEPPED UP AND REALLY INVITED US NIAMS AS WELL INVITED US THE THEIR COUNCIL, THEIR PLANNING EFFORTS, INCLUDED US IN THOSE EFFORTS IN THE BEGINNING SO WE HAVE BEEN WORKING THROUGH THAT. BUT HOPE THAT GIVES YOU A LITTLE PICTURE. >> ALONG THOSE LINES COULD BE INTERESTING IF THERE WAS AN OPPORTUNITY TO WORK WITH SENT FOR SCIENTIFIC REVIEW TO KNOW EXTENT WHICH STUDY SECTIONS WITHIN SPECIFIC DISCIPLINES. ADOPTING OR PAYING MIND TO SABV. IT MAY NOT BE EQUAL ACROSS ALL FIELDS AND THERE MAYBE SOME EDUCATIONAL OPPORTUNITIES FOR SOME FIELDS THAT MAY NEED IT MORE THAN OTHERS. >> A GREAT OPPORTUNITY WITH A NEW CSR DIRECTOR TO -- AND TO CONTINUE TO GROW THAT DISCUSSION WE DO AS YOU OF COURSE KNOW SEEK DISCIPLINE SPECIFIC DIFFERENCES AROUND SABV, GENERALLY, IT WOULD BE SURPRISING TO SEE STUDY SECTION DIFFERENCES BECAUSE THEY ARE COULD BE MIRRORING DISCIPLINES. RELATED OR FIELD RELATED DIFFERENCES, BUT GREAT SUGGESTION DAVID'S QUESTION THE NICHD MAKES TREMENDOUS SENSE S WHY NIDDK AND LESSONS TO LEARN THERE, WAS IT PERSONAL, POLITICAL, SOMETHING ELSE, SO WE HAVE SUPPORTED A VERY LARGE STUDY DPPOS, FOR MANY, MANY YEARS. AND I THINK THAT BECAUSE OF THAT LONG STANDING SUPPORT COMBINED WITH THEIR WILLINGNESS TO SPECIFICALLY ARTICULATE OUR SUPPORT, AS WELL AS TO RELATIONSHIPS ARE TWO WAY STREET SO WE DO HEAR ABOUT THE INVESTIGATORS WORK IN THEIR PUBLICATIONS OR FUNDING IS ACKNOWLEDGED THERE SO THAT GOES A LONG WAY FOR US, THERE'S ALSO THE STUDY, THERE ARE SCIENTIFIC CONNECTIONS, THERE ARE WHAT I CALL SCIENTIFIC AREAS OR TOPICS THAT ARE POISED TO MOVE FORWARD THERE. SO WHETHER YOU'RE HYPERGLYCEMIA DURING PREGNANCY IS HIGH ENOUGH TO MEET GESTATIONAL DIABETES DIAGNOSTIC CUT OFF WE NOW KNOW THE HYPERGLYCEMIA IS REALLY PROBLEMATIC AND YOU HAVE A TWO TIME TYPE 2 DIABETES WITHIN FIVE TEN YEARS, THOSE ISSUES ARE PUBLIC HEALTH ISSUES. SO EXACTLY DR. GRIF ROGERS WAS HERE AT THE LAST ACRWH SO PRESENT THAT WORK SO THERE'S SCIENTIFIC CONNECTIONS, SYNERGY SWEET SPOTS. WE ARE LOOKING FOR THOSE IN SOME CASES. IT'S A VARIETY OF EFFORTS. WE WANT TO LEVERAGE ALL. >> DR. MASURI. >> ONE OTHER ACTIVITY OFF MY EXPERIENCE WITH A LOT OF MY COLLEAGUES WHEN WE TALK ABOUT THIS ISSUE PARTICULAR AREAS IN BASIC SCIENCE WHERE IT'S VERY COSTLY TO DO THE EXPERIMENTS AND I'M THINKING OF STEM CELLS. THEY COMPLAIN ALL THE TIME IF THEY WANT TO DO MORE LOOKING AT SEX OF CELLS BUT THEY JUST CAN'T GET THE MONEY TO DO IT. THEY WRITE THEIR GRANTS IN A WAY THAT MAY STRATIFY OR MAY MAKE SOME CONSIDERATION FOR NOT STUDY SABV, BUT THAT'S ANOTHER COMMENT IN TERMS OF INSTITUTES THAT SUPPORT STEM CELL RESEARCH OR THE PORTFOLIO THAT FOCUS ON THAT MIGHT TAKE THAT INTO ACCOUNT. >> I HEAR YOU. I WILL ASK DR. HUNTER TO MAKE A COMMENT ON APPLICANTS MAKING THE CASE FOR THE BUDGET THAT THEY PUT FORWARD. CAN YOU COMMENT ON THAT? SHARON? ESPECIALLY IN SABV SPACE. WE ARE ENCOURAGING PEOPLE TO MAKE THE SPACE. >> WE ARE ENCOURAGING PEOPLE TO MAKE THE CASE. AS WHEN YOU ARE WRITING A GRANT YOU CAN JUSTIFY YOUR BUDGET. SO THEY SHOULD DO SO. AND NOT USE AS AN EXCUSE. NOT TO BE TRANSPARENT AND TO STUDY BOTH SEXES. >> THESE ARE OFTEN R O 1s. YOU ARE NOT OFFERING THOSE. I KNOW IT'S IN CONSIDERATION. BUT MAJOR CENTERS YOU DO LET US KNOW THAT. I'M TALKING ABOUT PEOPLE THAT YOU MEET IN THE HALLWAY AND THEY START TALKING ABOUT THEIR WORK AND TALKING LARGELY R MECHANISMS. >> YOU CAN GO OVER THE YOU CAN GO OVER THE NOMINAL CAP THAW SAY, YOU HAVE TO ITEMIZE. BUT HOPEFULLY THEY -- HOPEFULLY I KNOW IT'S NOT HERE YET BUT HOPEFULLY THE COURSE WILL BE USEFUL IN INFORMING PEOPLE ABOUT WHAT THE MYTHS ARE. IN APPLYING FOR A GRANT IN A COOPERATE -- INCORPORATING SABV. >> ANOTHER THING OF IN TERMS OF INTERSECTIONALITY THAT I WANT TO BRING UP IS DESEGREGATION OF DATA. FOR MOM RACE ETHNIC GROUPS, ASIANS SINCE WE'RE IN CALIFORNIA WE HAVE LARGE PERCENTS OF MANY DIFFERENT ASIAN GROUPS. THEY HAVE DIFFERENT BIOLOGY AND DIFFERENT SEX GENDER ISSUES, FOR INSTANCE DIABETES IS COMMON IN SOUTHEASTst EAST ASIAN WOMEN AND WE ARE LEARNING THAT THEY CAN BE AT COMPLETELY NORMAL BODY WEIGHT AND HAVE REALLY HIGH DIABETES BECAUSE THEY HAVE LOW MUSCLE MASS HIGH FAT MASS SO I FEEL IF WE ARE GOING TO DO WOMEN FULL JUSTICE WE NEED TO GO EVEN THE NEXT LAYER AND I SUSPECT IT'S ALSO TRUE OF HISPANIC WOMEN, I HAVE MANY STUDENTS THAT SAY THE DATA ARE ALL ABOUT WHEN THEY SAY HISPANIC DOES IT MEAN MEXICAN, CUBAN, DOES IT MEAN PUERTO RICAN, SO I FEEL WE CAN DO A GREAT SERVICE BY TRYING TO SHED SPOT LIGHTS ON ALL THOSE DIFFERENCES WHICH MAKE DIFFERENCES IN WOMEN'S HEALTH. >> THANK YOU FOR THAT. TYPICALLY WE PUT OUT THE WOMEN OF COLOR HEALTH DATA BOOK EVERY TEN YEARS AFTER THE CENSUS DATA. WE ARE LOOKING FOR A CENSUS IN 2020. SO HAVING YOUR INPUT ON STRATEGIES FOR MAYBE NEWER WAYS TO MAKE THAT INFORMATION USEFUL, IN THE HEALTH CONTEXT WOULD BE SOMETHING I WANT TO HEAR MORE FOR Y'ALL, SOUND LIKE Y'ALL WANT TO HEAR MORE FROM US AS WELL TO WHAT WE ARE DOING IN THAT SPACE. SO I'M GOING TO ASK MS. SPENCER TO MAKE A COUPLE OF COMMENTS BEFORE WE ADJOURN. >> JUST A QUICK THANK YOU TO ALL OF YOU FOR THE REVIEW CONTRIBUTIONS YOU HAVE MADE TO THE BY ANNUAL REPORT. IT'S STILL IN THE WORKS NOT QUITE DONE YET BUT WILL BE COMPLETED PRIOR TO OUR FALL MEETING FOR Y'ALL TO VOTE ON ACCEPTANCE BUT WE KNOW THAT WE SENT YOU A LOT OF DOCUMENTS IN A SHORT TIME AND TRULY APPRECIATE YOUR COMMENTS YOUR FEEDBACK. ALSO WE WELCOME YOUR FEEDBACK ON THIS MEETING. HOW IT PROGRESSED, IF YOU HAVE ANY COMMENTS, SUGGESTIONS FOR THE FALL WE WOULD LOVE TO HEAR THEM. PLEASE FEEL FREE TO SEND ME AN EMAIL AND WE'LL TRY TO IMPROVE ANYTHING WE CAN. THANK YOU ALL. SAFE TRAVELS HOME. >> WE ARE ADJOURNED. WE WILL SEE YOU FOR THE 49th MEETING OF THE ACRWH. MAYBE VIRTUALLY ON MAY 15th FOR THE VIVIAN PENN SYMPOSIUM DURING NATIONAL WOMEN'S HEALTH WEEK. THANK YOU. [APPLAUSE]