>> WE'LL START AT THE TABLE AND MAKE OUR WAY AND GIVE INTRODUCTIONS. AGAIN, GOOD MORNING. MY NAME IS JACE KILLSBACK, CO-CHAIR OF THIS COMMITTEE. GLAD TO BE BACK AND SEE EVERYBODY AGAIN. WE'LL GO AROUND THE TABLE. >> GOOD MORNING, EVERYONE, I'M LEE ANNA ONNEN, CHAIRWOMAN OF THE (INDISCERNIBLE) NATION CO-CHAIR WITH PRESIDENT KILLSBACK HERE, I ALSO SERVE ON THE NCAI EXECUTIVE BOARD AS SOUTHERN PLAINS VICE PRESIDENT, AND VERY GAD TO BE HERE THIS MORNING AND TO SEE ALL THE FAMILIAR FEESES AND NEW FACES, LOOKING FORWARD TO A GREAT COUPLE DAYS. THANK YOU. >> GOOD MORNING, DAVE WILSON, DIRECTOR OF TRIBAL HEALTH RESEARCH OFFICE HERE AT THE NIH, AND IT'S A PLEASURE TO SEE EVERYBODY HERE, LOOK FORWARD TO GREAT TWO-DAY SESSION. >> JIM ANDERSON, DEPUTY DIRECTOR, PART OF MY JOB IS TO MAKE SURE DAVE CAN SUCCEED AT HIS JOB. >> I'M (INDISCERNIBLE) ON THE EXECUTIVE BOARD FOR THE UNITED SOUTH AND EASTERN SOVEREIGNTY PROTECTION FUND WHICH SERVES TRIBES EAST OF THE MISSISSIPPI FROM MAINE, FLORIDA, EASTERN TEXAS. >> GOOD MORNING, MY NAME IS WALTER PHELPS, COUNCIL MEMBER WITH (INDISCERNIBLE) COUNCIL. GOOD MORNING. THANK YOU. >> GOOD MORNING, MY NAME IS JOSH SAXON WHITE CRANE, DELEGATE FROM CALIFORNIA. IF THERE ARE STRAGGLERS FROM CALIFORNIA WE NEED TO KNOW THEY ARE DELEGATES. >> I'M CHESTER ANTON, COUNCILMAN FROM THE (INDISCERNIBLE) NATION. >> GOOD MORNING, DANFORTH, ONEIDA NATION REPRESENTATIVE FROM WISCONSIN, AND I'M THE HEALTH DIRECTOR. >> GOOD MORNING, EDDIE JOHNSON FROM THE (INDISCERNIBLE) TRIBE, REPRESENTING ALL-AGENCY DISTRICT. >> GOOD MORNING, DENISE DILLARD, ALASKA AREA DELEGATE, KING TRIBAL COUNCIL, BOBBY SAUNKEHA, CHICKASAW NATION, DELEGATE FOR THE OKLAHOMA AREA. >> MALIA VILLLEGAS FROM ALASKA. >> JEROMJ SULLIVAN, PORTLAND AREA. >> CAROL DIXON, TECHNICAL ADVISER, PORTLAND AREA. >> MICHAEL PIERCEY, CHICKASAW NATION, TECH ANY ADVISER OKLAHOMA. >> TIMOTHY THOMAS, TECHNICAL ADVISER FOR ALASKA. >> YVONNE DAVIS WITH INDIAN HEALTH SERVICE DIVISION OF PLANNING, EVALUATION AND RESEARCH HERE IN ROCKVILLE, MARYLAND. [SPEAKING IN A FOREIGN LANGUAGE]. >> GOOD MORNING, THERESA JONG, AN ATTORNEY HERE WITH COUNCILMAN ANTON. >> TICIA SOLOMON, ARE. >> CORY NOVACK, COUNCIL FOR NOVACK IN THE CALIFORNIA AREA. >> GOOD MORNING, DAVID FOLEY, EPIDEMIOLOGIST WITH THE NAVAJO EPIDEMIOLOGY CENTER, HERE AS TECHNICAL ADVISER TO DELEGATE PHELPS. >> SARAH HULL, BIOETHICIST AT THE NIH, DUAL APPOINTMENT, GENOME AND INTRAMURAL RESEARCH ON CAMPUS. >> (INDISCERNIBLE) PRE-DOCTORAL FELLOW IN THE BIOETHICS DEPARTMENT. >> GOOD MORNING, CHRISTY DUKE, SENIOR EPIDEMIOLOGIST AT UNITED SOUTH AND EASTERN TRIBES AND I AM TECHNICAL ADVISER TO CHIEF BEVERLY COOK. >> GOOD MORNING, BRIANNE BABBLE, RESEARCH MANAGER FOR NAGSED A INDIAN HEALTH BOARD, TECHNICAL ADVISER FOR DEBBIE DAN FORTH. >> DEAN A AROUNDHIN, ADVISER TO DR. VELLEGAS. >> JOSEPH IRASTHEA, CHEYENNE RIVER ASSOCIATION, EAGLE BUTTE, HERE AS TECHNICAL ADVISER. >> GOOD MORNING, MARSHA O'LEARY, MISSOURI BREAKS RESEARCH GROUP OUT OF THE DAKOTAS, WE SERVE THE CHEYENNE RIVER PINE RIDGE AND STANDING ROCK RESERVATION AS WELL AS SPIRIT LAKE. >> DAVID WITH McGEE, NAVAJO NATION RESEARCH BOARD. >> LYLE BEST, ADVISER FORECOUNCILMAN JOHNSON, GREAT PLAINS AREA. >> BEVERLY PIGMENT, NAVAJO NATION REVIEW BOARD. IT'S GOOD TO BE HERE. THANK YOU. >> GOOD MORNING, MY NAME IS BEN SPANUM, NATIONAL HUMAN GENOME RESEARCH INSTITUTE, HERE AT NIH, I'M THE SENIOR ADVISER TO OUR DIRECTOR ON GENOMICS AND HEALTH DISPARITIES. >> GOOD MORNING, IT'S GREAT TO BE HERE, TED KEEN, I WORK FOR TRIBAL HEALTH RESEARCH OFFICE AT THE NIH. >> GOOD MORNING, IT'S GREAT TO BE HERE, MARISA RODRIGUEZ, I'LL BEGIN WORKING IN THE TRIBAL HEALTH RESEARCH OFFICE AS OF SEPTEMBER 25 SO I REALLY LOOK FORWARD TO WORKING WITH ALL OF YOU A LOT MORE >>> GOOD MORNING, DAN STINSON, POLICY REPORTING BRANCH AT THE NATIONAL HEART LUNG BLOOD INSTITUTE. >> GOOD MORNING, I'M CAROL SCHWARTZ, ASSOCIATE DIRECTOR FOR DIVERSITY AND WORKFORCE DEVELOPMENT AT THE CENTER FOR SCIENTIFIC REVIEW. >> GOOD MORNING, DOROTHY CASTILE, NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES. >> GOOD MORNING, ROBERTO DELGADO, NIMH REPRESENTATIVE ON THE NIH TRIBAL RESEARCH COORDINATING COMMITTEE. >> GOOD MORNING, (INDISCERNIBLE) WITH THE OFFICE OF SCIENCE POLICY AT THE NIH. >> GOOD MORNING, JULIANNA BLOOM, CHIEF OF STAFF FOR THE ECHO PROGRAM WHICH STANDS FOR ENVIRONMENTAL INFLUENCES ON CHILD HEALTH OUTCOMES. >> (INDISCERNIBLE) BLACKFEET. MY INDIAN NAME IS LONG TIME CHARGING INTO BATTLE WOMAN, AND MY ENGLISH NAME IS KIM PAUL, I AM HERE WITH NHGRI, NATIONAL HUMAN GENOME RESEARCH INSTITUTE, WORKING WITH MR. VINCE BONHAM AND LAWRENCE BRODY AS WELL AS DR. SARAH HULL IN BIOETHICS. >> HELLO, I'M A PROGRAM MANAGER AT THE NATIONAL LIBRARY OF MEDICINE, LAURA BARTLETT. >> GOOD MORNING, RACHEL TRACY, RESEARCH DIRECTOR AT THE INDIAN HEALTH SERVICE AND CHAIR THEIR NATIONAL IRB. >> GOOD MORNING, MARGO, CHIEF OF SCIENCE POLICY AND PLANNING NATIONAL INSTITUTE OF DENTAL AND CRANIAL YO FACIAL RESEARCH. >> GOOD MORNING. >> OFFICE OF SCIENTIFIC DIRECTOR.. DIRECTOR. >>> IS THERE ANYBODY ON THE PHONE? NO? OKAY. WELL, ARE YOU THERE? OKAY. WELL, WE'RE GOING TO MOVE FORWARD AND AGAIN NICE TO MEET EVERYBODY AND AGAIN WELCOME. YOU KNOW, WE HAD A GOOD SUMMER BREAK, ALL OF US, AND SOME OF US PROBABLY WENT THROUGH OUR SUMMER CEREMONIES, RENEWALS, AND SO WE ARE REFRESHED, REJUVENATED TO MOVE ON WITH BUSINESS AND LIFE. BUT I DID WANT TO HAVE A FEW STATEMENTS TO MAKE REGARDING OUR MEETING AND HOW WE OPEN IT UP. AND I'M GOING TO TURN THAT OVER TO MY CO-CHAIR, CHAIRWOMAN ONNAN. >> : GOOD MORNING. WE WANT TO THANK EVERYBODY FOR JOINING US IN PERSON OR REMOTELY THROUGH THE VIDEOCAST TO THE 2017 MEETING IN BETHESDA. NEXT I WOULD LIKE TO TURN IT OVER TO DR. ANDERSON TO GIVE US A WELCOME. >> : IT'S A BEAUTIFUL DAY. AS THE AJEAN DA CAME TOGETHER IT'S OBVIOUSLY THERE ARE A LOT OF POLICY ISSUES THAT WE'RE FOCUSING ON NOW AND WE BROUGHT OUR EXPERTS AND OUR DECIDERS AND THEY ARE HERE TO LISTEN. I HOPE WE HAVE SOME PRODUCTIVE DISCUSSIONS ABOUT THIS REALLY LONG LIST OF IMPORTANT POLICY THINGS TO TALK ABOUT. FRANCIS COLLINS WILL ALSO BE HERE A LITTLE LATER, AND LARRY TABAK, PRINCIPAL DEPUTY DIRECTOR, AND THEY LOOK FORWARD TO LISTENING, FRANCIS HAS NO STRUCTURED PRESENTATION, HE'S JUST HERE TO LISTEN AND TALK WITH YOU. THANK YOU. >> : THANK YOU, DR. ANDERSON. I'M GOING TO GO OVER A FEW THINGS RIGHT NOW, MEETING PROCEDURES. OUR PREVIOUS CHAIR, CO-CHAIR, WOULD SAY WE HAVE TO TALK ABOUT THE FACA EXEMPTION MEETING INFORMATION. I'M GOING TO READ THIS, TRIBAL ADVISORY COMMITTEES LIKE THE NIH TACH ARE DESIGNED TO BE FACA EXEMPT ADVISORY COMMITTEES, BECAUSE OF THE GOVERNMENT-TO-GOVERNMENT RELATIONSHIP THE OFFICE OF GENERAL COUNCIL LET US KNOW GUESTS CAN ATTEND MEETINGS BUT MAY NOT PARTICIPATE IN OPEN DISCUSSION AND WE CANNOT HAVE OPEN MIC TIME. HOWEVER NIH TAC MEMBERS WITH GIVE UP TIME TO OTHERS TO SPEAK ON THEIR BEHALF. WE'LL ASK TAC MEMBERS TO DESIGNATE GUEST SPEAKERS WHEN THEY PRESENTS ON IRBs AND OTHER PROGRAMS. WE WANT TO MAKE SURE THAT WE'RE FOLLOWING THE RULES TO THE BEST OF OUR UNDERSTANDING AS WE MOVE THROUGH HERE, SO JUST TRY TO KEEP THAT IN MIND. I'LL TRY TO REMIND YOU. WE'LL GO OVER WHAT WE HOPE TO ACHIEVE TODAY AND TOMORROW. THIS MEETING HAS BEEN IN THE WORKS AND WE'RE GLAD TO HAVE VERY IMPORTANT DISCUSSIONS AROUND DATA OWNERSHIP, OTHER NATIONAL ORGANIZATIONS AND GROUPS ARE ADDRESSING THIS IMPORTANT ISSUE, I WANT TO TAKE A MINUTE, THIS IS NOT ON PAPER BUT I'M GOING TO SHARE THAT IN MY COMMUNITY, WE DON'T HAVE AN IRB OR ANYTHING LIKE THAT. WE'RE SUCH A SMALL TRIBE WE DON'T HAVE THE NUMBERS, I APPROACHED TRIBES WITH AN IDEA SINCE WE'RE ALL SO SMALL PERHAPS WE COULD JOIN FORCES. WE DON'T HAVE THE NUMBERS BUT PERHAPS TOGETHER COULD FORM A FOUR-TRIBES COALITION IRB. I TALKED ABOUT SOME WORK WE'RE DOING HERE WHEN YOU TALK ABOUT DATA AND RESEARCH, PEOPLE ARE LIKE, OH NO, BUT PEOPLE CAN RESPOND, TAKING IT TO A LEVEL WHERE COMMUNITIES UNDERSTAND THE IMPORTANCE OF WHAT WE'RE DOING HERE. IT'S NOT ONLY GOING TO SUPPORT THE COMMITTEE WILL YOU GROWING IN PARTNERSHIP. THAT'S MY SCHPIEL TO SHARE WITH EVERYONE. WE'RE EXPECTING SEVERAL OUTCOMES, WE'RE HOPING TO GET MORE INFORMATION FROM THE AGENCY ABOUT SPECIFIC NIH RESEARCH POLICIES THAT WILL SOON BE IMPLEMENTED. WE ALSO FROM THE TRIBAL PRESENTERS ARE HOPING TO UNDERSTAND PROCESSES AROUND RESEARCH CONDUCTED IN OUR COMMUNITIES, AND THE THIRD THING IS THAT THIS IS A FORUM TO HOLD DISCUSSION ON HOW TRIBES AND NIH CAN WORK TOGETHER TO DEVELOP POLICIES AND PROGRAMS AROUND RESEARCH THAT BENEFIT BOTH SIDES. AND I KNOW MANY OF YOU IN THIS GROUP SO WE'RE VERY MUCH LOOKING FORWARD TO A PRODUCTIVE MEETING. PRESIDENT KILLSBACK WILL NOT BE HERE TOMORROW. HE WILL HELP ME OUT TODAY. TOMORROW I'M ON MY OWN. SOMEBODY BE READY TO HELP ME TOMORROW. TAKE LOOK AT THE AGENDA. I'M BIG ABOUT KEEPING US ON TIME. DON'T BE AFFRONTED IF I INTERRUPT, WE WANT TO STAY ON TIME, TO THE BEST OF OUR ABILITY. THE LAST THING, I WANT TO SAY AND REMIND EVERYBODY THAT UNDER FEDERAL RULES THE ORGANIZATION HERE CANNOT PURCHASE FOOD SO PLEASE IF YOU HAVE A MOMENT MAKE SURE YOU THANK THE NIH STAFF BECAUSE THEY HAVE TAKEN UP COLLECTIONS AND DONATIONS TO MAKE SURE WE HAVE SOME FOOD AND SNACKS AND REFRESHMENT, WHICH IS REALLY IMPORTANT BECAUSE THE LAST THING YOU WANT IS FOR ME TO GET HANGRY. THANK YOU ALL VERY MUCH, STAFF AT NIH, FOR THAT. I'M PLEASED BECAUSE WE'RE TEN MINUTES AHEAD OF SCHEDULE. DR. DAVID WILSON IS IS THE DIRECTOR OF THE TRIBAL RESEARCH OFFICE AT NIH FOR THOSE THAT MAY NOT KNOW COORDINATING RESEARCH ACROSS CENTERS, INSTITUTES, ADJUNCT PROFESSOR AT THE JOHNS HOPKINS SCHOOL OF PUBLIC HEALTH AT THE CENTER FOR AMERICAN INDIAN HEALTH AND HAS BEEN WORKING QUITE HARD, SO THANK YOU. >> : IT'S A PLEASURE TO BE HERE TO GIVE YOU UPDATES ABOUT THE TRIBAL HEALTH RESEARCH OFFICE. I WANT TO INTRODUCE SOME NEWEST MEMBERS, TED KEHNE. >> : THANK YOU FOR HAVING ME. I SPENT TWO YEARS IN A MASTERS PROGRAM STUDYING INTERNATIONAL HEALTH AT THE JOHNS HOPKINS SCHOOL OF PUBLIC HEALTH, AND RESEARCH IN SEVERAL AREAS INCLUDING VACCINE RESEARCH AND DEVELOPMENT, MATERNAL AND REPRODUCTIVE HEALTH AND NUTRITION AND SPENT A YEAR AT THE CENTER FOR AMERICAN INDIAN HEALTH AS ONE OF THE FIRST EXPERIENCES RESEARCHING. >> : NEXT MARISA RODRIGUEZ. >> : IT'S AN HONOR TO BE HERE. I'M LOOKING FORWARD TO WORKING WITH THE TRIBAL HEALTH RESEARCH OFFICE, BEGINNING NEXT MONDAY, SO THAT WOULD BE SEPTEMBER 25. AND AFTER EARNING MY MASTER'S DEGREE IN BUSINESS ADMINISTRATION, I WORKED VERY CLOSELY WITH TRIBES ACROSS THE ENTIRE NATION, WITH THE ADMINISTRATION ON AGING, ADMINISTRATION FOR COMMUNITY LIVING. AGAIN, THANK YOU VERY MUCH FOR HAVING ME TODAY. >> : I WILL JUMP INTO THE ACTIVITIES. I WANT TO BREAK UP MY HAWK INTO SEGMENTS. FOUR MAJOR POINTS, MEETINGS, STUDENT ENGAGEMENT, TRIBAL HELD RESEARCH COORDINATING COMMITTEE INTRODUCED EARLIER, AND SOME OF THE PUBLICATIONS THAT THE OFFICE HAS BEEN WORKING ON. WE'VE BEEN BUSY IN STANDING UP THE OFFICE. THE MEETINGS ARE SO IMPORTANT AS WE GET THE WORD OUT, THRO HAS MADE PROGRESS. MEETINGS SERVE SEVERAL GOALS AND SEVERAL OBJECTIVES. ONE THING IS COMMUNICATE THAT OUR OFFICE IS UP AND RUNNING, AND THE NEXT IS TO TALK ABOUT WHAT'S THE VISION FOR OUR OFFICE AND HOW DO WE BEST THINK ABOUT HOW THIS IS GOING TO SERVE THE TRIBAL COMMUNITIES. NEXT IS WHAT ARE THE COMMUNITY-SPECIFIC NEEDS. THEY VARY DIFFERENTLY AS EVERYBODY KNOWS, 567 TRIBES, THERE'S A LOT OF REGIONAL DIFFERENCES BETWEEN TRIBAL COMMUNITIES, IT'S IMPORTANT TO DETERMINE SPECIFIC NEEDS IN THE AREA. ALSO IDENTIFYING AREAS OF COLLABORATION, MANY AREAS HAVE ALREADY STARTED UP INITIATIVES THAT ARE WELL UNDERWAY AND HOW CAN WE COMPLEMENT THOSE AREAS MOVING FORWARD. ALSO WHAT ARE ALREADY EXISTING IN THE AREA IN TERMS OF PROGRAMS, INFRASTRUCTURE THAT WE CAN AGAIN SYNERGIZE TO MAKE MORE EFFECTIVE AND ABOVE ALL WE'VE BEEN ACTIVELY RECRUITING RECOMMENDATIONS FOR OUR STRATEGIC PLAN. THIS HAS BEEN A REALLY GREAT OPPORTUNITY FOR TO US TALK ABOUT HOW TRIBAL COMMUNITIES THINK THE TRIBAL HEALTH RESEARCH OFFICE SHOULD MOVE FORWARD TO BEST SERVE THE TRIBAL COMMUNITIES AND IT'S BEEN REALLY EFFECTIVE SO FAR. AND THIS IS REALLY IMPORTANT BECAUSE THIS, THE MEETINGS, THEY SERVE TWO DIFFERENT AREAS. A LOT OF QUESTIONS WE ASK HERE ARE NOT ONLY APPLYING TO EXTERNAL STAKEHOLDERS BUT INTERNALLY TO THE AGENCY BECAUSE A LOT OF THE ICs ARE UNAWARE OF TRIBAL HEALTH RESEARCH OFFICE AND ITS EXISTENCE SO WE'VE BEEN ENGAGING IN A LOT OF MEETINGS, AND ALSO COMING INTO THIS WHAT ARE ISSUES THAT MIGHT NEED TO BE ADDRESSED THAT ALREADY EXIST WORKING WITHIN TRIBAL COMMUNITIES. SO THESE ARE REALLY INTERESTING OPPORTUNITIES FOR U S M O V ING FORWARD. I'VE BEEN RACKING UP THE TRIBAL MILES. I WANT TO LIST HIGHLIGHTS HERE. WE WERE THERE IN JUNE AND HAD A TERRIFIC ENGAGEMENT, WE HAD OUR CONSULTATION THERE TO GET IDEAS FROM THE COMMUNITY ABOUT THE STRATEGIC PLAN, AND IT WAS EXTREMELY PRODUCTIVE, MET LOTS OF FOLKS AND HAD A REALLY GREAT TIME, EVEN THOUGH MY PLANE WAS DELAYED ON THE FIRST DAY. WE'VE ALSO PARTICIPATED IN THE AMERICAN INDIAN HIGHER EDUCATION CONSORTIUM BEHAVIOR HEALTH INSTITUTE, THIS WAS A VERY GOOD INITIAL ENGAGEMENT THAT WILL LEAD TO FURTHER ACTIVITIES THAT WE WERE ASKED TO COME BACK AND PROVIDE TECHNICAL ASSISTANCE, A NARCH-FUNDED PROGRAM BY NIGMS, WE'RE LOOKING TO FORM DIFFERENT PARTNERSHIPS IN OTHER ICs AS WELL. WE WENT TO THE 14th BIANNUAL JOINT BOARD OF DIRECTORS MEETING AT THE REQUEST OF THE OUTGOING DELEGATE PHELPS AND CAROL DIXON, A REALLY GREAT OPPORTUNITY TO MEET THE COMMUNITY, TO TALK ABOUT HOW IMPORTANT IT IS TO HAVE THEIR PARTICIPATION IN THE TRIBAL ADVISORY COMMITTEE. IF ANYBODY NEEDS THAT KIND OF ENGAGEMENT, PLEASE LET US KNOW. WE ARE HAPPY TO GO OUT AND TO TALK TO TRIBAL DELEGATES, TRIBAL LEADERSHIP ABOUT WHAT OUR COMMITTEE IS DOING, WHAT ARE SOME OF THE NEW INITIATIVES WITHIN THE AGENCY TO HELP SUPPORT IN THAT AREA. ANOTHER THING THAT'S REALLY IMPORTANT IS THE NAVAJO NATION, WE RECENTLY WENT TO THE NAVAJO NATION AND HELD A LISTENING TOUR WITH THE ECHO PROGRAM. DR. JULIANNA BLOOM, CHIEF OF STAFF, SHE WAS ONE OF THE KEY PLAYERS IN THIS, AND IT WAS REALLY EXTREMELY BENEFICIAL ENGAGEMENT ON BOTH SIDES. NOT ONLY WERE WE ABLE TO HEAR ABOUT TRIBAL CONCERNS ABOUT THE DATA PLATFORMS AND GENETICS RESEARCH THAT HAPPENS, THAT'S GOING TO HAPPEN IN THE PROGRAM, BUT WITHIN THE COMMUNITY, WHAT WERE THEIR MAJOR CONCERNS, AND IT WAS REALLY A UNIQUE OPPORTUNITY FOR THE DIRECTOR TO LISTEN TO THESE CONCERNS AND TAKE THEM INTO CONSIDERATION AND FIGURE OUT TOGETHER STRATEGIES ON HOW TO ACCOMMODATE THOSE. SO IT'S A REALLY GREAT EFFORT AND DR. BLOOM WILL TALK ABOUT THAT LATER. I DID TALK ABOUT SOME OF THE INTERNAL MEETINGS HERE. YOU CAN SEE WE'VE HAD THE OPPORTUNITY AND IT'S REALLY BEEN GREAT TO MEET WITH A LOT OF DIFFERENT IC DIRECTORS OR SENIOR STAFF, AND I KNOW THIS IS ACRONYM HEAVY. I DIDN'T HAVE THE SPACE TO PUT EVERYTHING OUT THERE BUT THE NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES, GENERAL MEDICAL SCIENCES, NATIONAL INSTITUTE ON DRUG ABUSE, NATIONAL INSTITUTE ON MENTAL HEALTH, NATIONAL INSTITUTE OF MEDICINE, NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH, SO THE LIST GOES ON HERE. IT'S BEEN REALLY GOOD FIGURING OUT WAYS TO COLLABORATE MOVING FORWARD. VARIOUS PROGRAMS HAVE A GOOD REPRESENTATION OR HAVE VERY NATIVE FOCUS EFFORTS, THE ECHO PROGRAM, THE "ALL OF US," A LOT OF PEOPLE ARE EXCITED TO HEAR UPDATES FROM THESE TWO PROGRAMS. THE NATIVE AMERICAN RESEARCH CENTERS FOR HEALTH PROGRAM, THAT'S G.M. SPONSORED PROGRAM AND THE SCIENCE EDUCATION PARTNERSHIP AWARD, A PROGRAM THAT MANY FOLKS DON'T KNOW ABOUT BUT IT'S FOCUSED ON K-12 EDUCATIONAL OUTREACH SO THAT'S A REALLY IMPORTANT ONE AS WELL. THE STRONG HEART STUDY, WHAT WE'LL HEAR IMMEDIATELY AFTER THIS. WITHIN DIFFERENT OFFICES, INTRAMURAL OFFICE OF TRAINING AND EDUCATION, A HUGE AND CRITICAL PLAYER IN DEVELOPING THE TRAINING EFFORTS THAT ARE INTERNALLY WITHIN THE AGENCY, THAT SERVES A LOT OF INTERNS THAT COME INTO THE AGENCY TO DO SUMMER INTERNSHIPS OR POSTBACS OR POSTDOCS, SO A REALLY IMPORTANT OFFICE TO ENGAGE WITH. OTHERS HERE, YOU CAN SEE SGMRO, OFFICE OF PORTFOLIO ANALYSIS OFFICE POLICY, TALKING ABOUT WHETHER WE CAN PARTNER AND WHERE WE CAN BEST SERVE TRIBAL COMMUNITIES. THIS IS ONE I WANT TO HIGHLIGHT, IT SEEMS LIKE IT'S BEEN QUITE A WHILE AGO, TRIBAL SHARING GENETICS WORKSHOP AT THE UNIVERSITY OF NEW MEXICO COMPREHENSIVE CANCER CENTER. THE ONLY WORDS I CAN USE TO DESCRIBE THIS, EXTREMELY HISTORIC AND TRANSFORMATIONAL. IT WAS JUST A PHENOMENAL EVENT WHERE NOT ONLY THE AGENCY BUT THE COMMUNITY AND LEADERSHIP WERE ABLE TO COME TOGETHER AND HAVE VERY CANDID CONVERSATIONS ABOUT GENETIC RESEARCH AND ITS IMPORTANCE IN OPPORTUNITIES SO WE'LL HEAR MORE ABOUT THAT I THINK LATER ON, BUT THIS WAS JUST AN AMAZING EVENT HERE. YOU CAN SEE THERE'S SOME OF OUR LEADERSHIP UP THERE AND I'M NOT ASLEEP, I'M READING SOMETHING. [LAUGHTER] THIS WAS A COLLABORATIVE EFFORT INSIDE AND OUTSIDE, WITH PARTNERS AT THE UNIVERSITY OF WASHINGTON, AND THIS EFFORT WAS BUILT OFF PREVIOUS WORK THAT HAS BEEN DONE AROUND GENETIC RESEARCH IN TRIBAL COMMUNITIES, SO THIS WAS JUST ANOTHER STEP THAT WE WERE ABLE TO TAKE TO GET US TO WHERE WE'RE AT NOW. AND BY NO MEANS IS THIS WORK FINISHED, BUT IT'S A GOOD START FOR US MOVING FORWARD. WE WERE HONORED TO BE PART OF IT. THIS IS ARE PICTURES FROM THE LISTENING SESSION AT THE NAVAJO NATION. IT WAS REALLY GOOD. THIS IS SOMETHING THAT WE REALLY ARE HOPING TO UNDERSTAND EFFECTIVE COMMUNICATION, THAT'S ONE EVER OUR PILLARS OF OUR STRATEGIC PLAN, INCREASING COMMUNICATION BETWEEN AGENCY AND TRIBAL COMMUNITIES, CONVERSATIONS WITH PRESIDENT BEGAY, PHELPS, GILMAN, BLOOM, I'M THERE. ALL THE KEY PLAYERS WERE HERE TO TALK. WE TOURED THE NAVAJO NATION HEALTH DEPARTMENT, A GOOD SENSE FOR WHERE COLLABORATIONS WERE, MOVING FORWARD WITH A LOT OF THOSE. ANOTHER THING IS STUDENT ENGAGEMENT. NEAR AND DEAR TO MY HEART. WE'VE HAD THE OPPORTUNITY TO NOT ONLY ENGAGE WITH THE NIH SUMMER INTERNS WHO COME IN BUT ALSO POLICY FELLOWS, THE NATIONAL HUMAN GENOME RESEARCH INSTITUTE HOSTED NATIONAL INDIAN HEALTH BOARD POLICY FELLOWSES, WE HAD CONVERSATIONS WITH THEM, THEY TOURED DIFFERENT SITES, NATIONAL CONGRESS, AMERICAN ASSOCIATION OF INDIAN PHYSICIAN STUDENTS WERE HERE AS WELL. IF THEY COME TO THE D.C. AREA WE WOULD LIKE THEM TO AT LEAST MAKE A STOP TO SEE WHAT THE AGENCY IS ALL ABOUT. AND THIS IS A COORDINATED COMMITTEE. THIS IS OUR TRANS-NIH TRIBAL HEALTH RESEARCH COORDINATING COMMITTEE. IN APRIL OF THIS YEAR WE HELD OUR FIRST MEETING. THIS GROUP IS REPRESENTATIVES FROM ACROSS THE NIH, SO ALL THE DIFFERENT INSTITUTES AND CENTERS HAVE NOMINATED ONE PERSON TO SIT ON THIS COMMITTEE, AND THEY HAVE BEEN VERY GOOD AND EXTREMELY HARD WORKING COLLABORATORS. THEY HAVE WORKED ON SEVERAL PROJECTS, AND THIS ISN'T EVERYBODY, BUT IT'S MOST EVERYBODY. HERE YOU CAN SEE SOME OF THE THINGS WE'VE BEEN WORKING ON, DRAFTING THE FIRST AMERICAN INDIAN ALASKA NATIVE PORTFOLIO. OUR STRATEGIC PLAN, WE'VE BEEN WORKING ON TOGETHER ACTIVELY COLLABORATIVE EFFORTS BETWEEN THE ICs AND THE OFFICE. THE NHGRI GENOMICS INITIATIVE WITH THE NAVAJO NATION. IT'S BEEN GREAT TO SEE OTHER INSTITUTES STEP UP AND PARTICIPATE IN ACTIVITIES IN COLLABORATION WITH THRO, WE HAD THE NATIONAL INSTITUTE OF MENTAL HEALTH GO TO THE FIRST ANNUAL TRIBE LEADERS BEHAVIORAL HEALTH SUMMIT IN TULSA, GREAT FOR THEM TO BE THERE ON BEHALF OF THRO AND THE AGENCY. WE'VE BEEN WORKING WITH THE NATIONAL INSTITUTE OF MINORITY HEALTH ON INCREASING OUR SUPPORT FOR THE TRIBAL EPICENTERS, AND I'M HAPPY TO ANNOUNCE A RECENT RFA PUBLISHED YESTERDAY, AND SO WE HAVE MORE INFORMATION ABOUT THOSE IN THE BACK SO IF YOU'RE INTERESTED IN PICKING THOSE UP THEY ARE LISTED RIGHT THERE BELOW. WITH THE NATIONAL INSTITUTE OF GERONTOLOGICAL SCIENCES WORKING WITH THE NARCH PROGRAM, HAPPY TO FIND WAYS TO WORK TOGETHER. STUDENT TRAINING AND DEVELOPMENT, THIS IS A BIG THING THAT THE COMMITTEE HAS BEEN WORKING ON THAT OUR GOAL IS TO REALLY CREATE A UNIFIED TRANS-NIH SUPPORT SYSTEM AND PROGRAM, SO WHEN STUDENTS COME HERE THEY HAVE A LIBRARY, A CATALOG OF OPPORTUNITIES AVAILABLE TO THEM AND WE WILL BE ABLE TO SUPPORT THEM AND MENTOR THEM AND PROVIDE A LOT OF THE TRAINING THAT'S NECESSARY TO MAKE SURE TO INCREASE THE RESILIENCE IN THE FOREIGN COMMUNITY OF SCIENTISTS, SO IT'S SOMETHING THAT'S REALLY IMPORTANT TO US AND WE'RE BEGINNING TO MOVE FORWARD ON THAT. THE STRATEGIC PLAN, ALL OUR ENGAGEMENTS ACROSS THE COUNTRY AND DIFFERENT COMMUNITIES AND EVEN IN OUR TRIBAL HEALTH COORDINATING COMMITTEE, WE WERE ABLE TO COME UP WITH FIVE PILLARS, PART OF THE STRATEGIC PLAN, ENHANCING COMMUNICATION AND COORDINATION, AND WITHIN ALL THIS THE MOST IMPORTANT THING IS MAKING SURE THAT WE LAYER ON TO THIS THE CULTURAL COMPETENCY AND COMMUNITY ENGAGEMENT, IN THE BACK OF OUR MINDS WHEN WE REACH INTO THE PILLARS IN THE STRATEGIC PLAN. THIS IS VERY UNIQUE. I THINK THIS IS SOMETHING THAT WE WANT TO DO TO CAPTURE A HOLISTIC APPROACH TO HOW THE OFFICE ENGAGES TRIBAL COMMUNITIES AND THIS IS -- WE'RE GOING TO START WITH TRIBAL HEALTH RESEARCH OFFICE AND MAKE SURE THAT THIS MATRICULATES INTO THE REST OF THE AGENCY. SO THIS IS A REALLY GOOD START FOR US. WE'RE FINDING OPPORTUNITIES TO PUBLISH. THE FIRST THING, COMMUNICATING WITH THE OFFICE HERE, THE MOST EFFECTIVE WAY WAS AS TRIFOLD. THE DEPUTY IS A MASTER IT'S A THIS AND HAD A HUGE PART IN HELPING ME DEVELOP THIS HANDOUT AND WE HAVE SOME IN THE BACK BUT I THINK A LOT OF PEOPLE HERE IN THE ROOM HAVE ALREADY RECEIVED THAT. YOU CAN SEE I HIGHLIGHTED EVERYBODY IN THE ROOM, THE PICTURE IN THE LEFT-HAND CORNER. ANOTHER IMPORTANT DOCUMENT THAT WE PUBLISHED WAS A COMMENTARY ON THE BELMONT REPORT, AND THIS IS ALSO INCLUDED IN YOUR BINDERS BUT THIS IS A REALLY IMPORTANT OPPORTUNITY FOR US TO TALK ABOUT THE IMPORTANCE OF INCLUDING THE COMMUNITY PERSPECTIVE AND COMMUNITIES, UNDERSTANDING IMPORTANCE OF HAVING COMMUNITY WHEN YOU'RE TALKING ABOUT INDIVIDUAL PROTECTIONS AND TRIBAL NATIONS THAT THE COMMUNITY HAS TO BE TAKING INTO CONSIDERATION AND DR. HULL WILL TALK MORE ABOUT OUR EFFORT IN THIS AREA, DURING HER PRESENTATION. AS WE BEGIN TO DELVE INTO THE NAVAJO NATION EFFORT, ONE OF THE THINGS THAT WE -- NOT ONLY THROUGH COMMUNITY ENGAGEMENT BUT LEADERSHIP INPUT WERE ABLE TO DETERMINE THERE NEEDED TO BE A DOCUMENT OR RESOURCE CREATED TO HELP SUPPORT THE PEOPLE WHO WERE ENGAGING COMMUNITY MEMBERS TO TALK ABOUT WHAT IS GENETIC RESEARCH AND WHAT ARE THE BENEFITS OF IT. SO THEY WERE GRACIOUS ENOUGH TO PUT TOGETHER A TEAM AT NHGRI TO DRAFT THIS DOCUMENT AND IT'S ALL IN YOUR FOLDERS AS WELL. IT'S EMBEDDED WITH LINKS AND A LOT OF INFORMATION, YOU CAN GO INTO GENETIC INFORMATION AS DEEP AS YOU WANT. WE'RE LOOKING FOR COMMUNITY MEMBERS TO USE THIS WHEN TALKING ABOUT GENETIC RESEARCH. THIS DOCUMENT, WE'RE THINKING ABOUT OUR FUTURE AMBITIONS TO GET THIS TRANSLATED INTO NAVAJO BECAUSE IT'S IMPORTANT BECAUSE THE LANGUAGE THERE ARE NO TECHNICAL TERMS WITHIN MANY OF OUR TRIBAL INDIGENOUS LANGUAGES SO WHEN THE COMMUNICATION OR CONVERSATIONS HAPPEN IT COMES FROM THE SAYS -- SAME PLACE AND EVERYBODY IS ON THE SAME LEVEL. I APPRECIATE NHGRI'S EFFORT IN THIS. NOW WE MIGRATE BACK TO OUR NIH TRIBAL ADVISORY COMMITTEE, AND THIS IS -- WE'VE BEEN BUILDING THIS WEBSITE OVER THE LAST 7 MONTHS, QUITE EXTENSIVELY. IT'S GONE THROUGH A NUMBER OF REVISIONS. I ENCOURAGE EVERYBODY HERE WHO IS AT THE COMMITTEE TO UTILIZE THE WEBSITE AS A RESOURCE, WHEN YOU'RE TALKING TO COMMUNITY MEMBERS, TALKING TO TRIBAL LEADERSHIP OR COUNCIL MEMBERS, GO THROUGH HERE AND YOU CAN SEE HERE THERE'S -- WE HAVE OUR MEETING AGENDA, UPCOMING DATES. WITHIN HERE WE HAVE OUR MEETING NOTES AND WHAT WE'VE TALKED ABOUT. SO IT'S A REALLY GREAT RESOURCE. WE PUT THE PUBLICATIONS WE'VE BEEN ABLE TO PRODUCE IN ONE OF THE TABS UP THERE SO PLEASE, USE THIS AS A RESOURCE. WILL THAT I WILL CONCLUDE MY PRESENTATION. THANK YOU VERY MUCH. [APPLAUSE] WE'RE WORKING ON THE PORTFOLIO ANALYSIS AND STRATEGIC PLAN AND INTERNSHIP, TRANS-NIH PROGRAM FOR SUMMER INTERNS. I WILL TAKE QUESTIONS FROM ANYBODY. >> : YES, QUESTIONS FOR DR. WILSN? >> THANK YOU SO MUCH. A QUICK QUESTION, IS THIS ELECTRONIC? I SEE SOME LINKS, ARE THERE ANY PLANS TO UPDATE THIS MAYBE ANNUALLY GIVEN SOME PROJECTS THAT ARE HIGHLIGHTED? >> WE PROVIDED USB THUMB DRIVES, HARD COPY FOR THOSE WHO WANTED A GLIMPSE WHILE THERE BUT THUMB DRIVES SO THEY COULD TAKE IT AND ACCESS THE LINKS FROM ANYWHERE. >> : I WANT TO SAY THANK YOU TO DR. WILSON AND ALSO NIH PERSONNEL THAT HAVE SPENT TIME VISITING NAVAJO. DR. BLOOM, OTHERS THAT CAME OUT TO DISCUSS FROM LEADERSHIP LEVEL TO THE CONFERENCE A COUPLE DAYS AGO. I THINK THAT HAVING THESE CONVERSATIONS AT THIS LEVEL REGARDING DATA SHARING AND, YOU KNOW, TALKING ABOUT, YOU KNOW, WHERE WE'RE GOING TO GO FORWARD ON A LOT OF THESE ISSUES I THINK IS VERY -- I'M LOOKING FORWARD TO INPUT FROM MY COLLEAGUES HERE ON THIS COUNCIL SO WE CAN INCORPORATE MAYBE SOME OF THOSE RECOMMENDATIONS AND IDEAS AND I REALLY APPRECIATE DR. WILSON'S LEADERSHIP IN THIS AREA AS WELL. AND HIS EXPERTISE. I MEAN, I'M JUST A SHEEP HERDER FROM BACK HOME BUT HE'S THE EXPERT DOWN HERE, SO I ALSO APPRECIATE OUR TECHNICAL ADVISORS AS WELL. ALSO I WANT TO SAY WELCOME. I KNOW THEY ARE ON THE REPORT BUT I'M REALLY EXCITED TO HAVE MY NAVAJO IRB LEADERS HERE, AND REALLY APPRECIATE THEIR PRESENCE HERE AS WELL. I WANT TO SAY THANK YOU. THANK YOU, DR. WILSON. >> : DENISE? >> I WANTED TO THANK NIH FOR -- I'M SO PLEASED THAT DAVE HAS SOME HELP BECAUSE I KNOW WHEN THIS OFFICE WAS CREATED ONE OF THE CONCERNS I HAD IS THAT IT MIGHT BE A ONE-PERSON SHOW AND THERE'S TOO MUCH WORK FOR ONE PERSON. I APPRECIATE YOU FOR THE TREMENDOUS AMOUNT OF WORK. >> : IT'S ABOVE OUR EXPECTATIONS, FROM WHEN WE WANTED THIS MOVEMENT THAT WE'RE HEADED. DEFINITELY PUTTING US ON THE MAP BUT MAKING US PROUD REALLY. I'M PROUD OF THE WORK YOU'RE DOING, DR. WILSON. >> : APPRECIATE THAT. AND THIS WORK WOULDN'T BE POSSIBLE WITHOUT THE FULL SUPPORT OF DR. ANDERSON, DPCPSI AND NIH LEADERSHIP. >> : CHAIRWOMAN? >> I JUST WANTED TO COMMENT THAT I THINK IT'S IMPORTANT TO COMMENT THAT I'M REALLY PLEASED WITH WHAT I'VE SEEN TODAY, IT'S ORGANIZED WHERE THESE ARE THINGS SOME OF US HERE RIGHT FROM THE BEGINNING WERE LIKE HOW ARE WE GOING TO GET THERE, THESE ARE THE THINGS WE NEED TO DO. I'M SEEING IT FORM UP. I CAN'T TELL YOU HOW HAPPY THAT MAKES ME. MAKES ME VERY HAPPY TO SEE THAT HAPPENING. AND I JUST WANTED TO ALSO MAKE A COMMENT THAT I REALLY LIKE TO SEE THE ENGAGEMENT THAT YOU GUYS ARE DOING WITH THESE OTHER NATIONAL BOARDS AND ORGANIZATIONS. I KNOW YOU WILL CONTINUE BUT I STRONGLY, STRONGLY ENCOURAGE YOU TO CONTINUE DOING THAT BECAUSE I BELIEVE THAT YOU WILL CONTINUE TO GAIN INSIGHT, GUIDANCE AND EVEN INSPIRATION FROM THESE ORGANIZATIONS ON HOW TO THINK OUTSIDE OF WHAT WE'RE SO PROGRAMMED TO THINK AND IT JUST GIVES INSPIRATION AND IDEAS AND I CAN SEE THAT REFLECTED IN THE WORK THAT YOU'RE DOING. I JUST WANTED TO TAKE A MOMENT TO SAY THAT AND THANK YOUR NEW STAFFERS AND DR. ANDERSON AS WELL. THANK YOU. >> : OUR GOAL IS TO PROVIDE AS MUCH EXPOSURE TO THE PROFESSIONAL OPPORTUNITIES THAT EXIST HERE WITHIN THE AGENCY. WE KNOW THAT WHEN STUDENTS COME AND THEY HAVE THESE SIX OR EIGHT-WEEK INTERNSHIP OPPORTUNITIES THAT MAY BE THEIR FIRST TRIP OUTSIDE OF THE RESERVATION OR OUTSIDE THE HOMELANDS. IT'S IMPORTANT FOR THEM NOT TO BE ABLE TO SEE A SPECIFIC GLIMPSE OF THAT BUT TO SEE A BIGGER BROADER PICTURE. SO IF THEY GO INTO A POLICY POSITION, THEY ARE NOT EXCITED ABOUT THAT BUT THEY COME HERE AND THEY SEE THE ZEBRAFISH FACILITY THAT WE HAVE AND EXCITED ABOUT RESEARCH ON ZEBRAFISH WE WANT THEM TO HAVE THAT OPPORTUNITY. >> : ANY MORE QUESTIONS? COMMENTS? ALL RIGHT. THANKS, DOCTOR. >> : THANK YOU. [APPLAUSE] >> : AGAIN, THE NETWORKING YOU'RE DOING IS SOMETHING EVEN AT LEADERSHIP LEVEL HAVEN'T BEEN ABLE TO DO WITH SOME OTHER NATIONAL ORGANIZATIONS. THE NEXT STEP FOR THE BODY, MAYBE IT'S NOT OFFICIAL, WE DO IT AS AN ACTUAL COMMITTEE, A TAC COMMITTEE, IN OUR CAPACITY AS TRIBAL LEADERS NETWORKING WITH THESE OTHER BOARDS AND COMMITTEES AT PROGRAMS AND NON-PROFITS YOU WERE TEAMING UP WITH. SO SOME OF US HAVE DIFFERENT ROLES AND RESPONSIBILITIES IN OTHER COMMITTEES AND OTHER WORK, AND SO WE'RE STARTING TO MAKE THOSE CONNECTIONS THAT HAVEN'T BEEN THERE. AGAIN, THANKS. SO OUR NEXT ITEM ON THE AGENDA IS THE STRONG HEART STUDY PRESENTATION AND DR. . DR. LYLE BEST WORKED WITH THE IHS FOR OVER 20 YEARS, FIRST 16 YEARS AS CLINICAL DIRECTOR, LATER AS MATERNAL CHILD HEALTH CONSULTANT FOR NINE HOSPITALS, TEN CLINICS IN THE DAKOTAS, CONDUCTED GENETIC RESEARCH IN AMERICAN INDIAN COMMUNITIES AS A PART-TIME BASIS THROUGH HIS CAREER, SINCE 2000 AS PRINCIPAL INVESTIGATOR FOR FOUR STUDIES INCLUDING GENETICS AND PRE-ECLAMPSIA. THE FLOOR IS YOURS. >> : I THANK THE COMMITTEE FOR ALLOWING US TO SPENDS TIME DISCUSSING THE STRONG HEART STUDY. I SPOKE WITH DR. PUGGAL EARLIER, WE SHE SEEMED SHY AND WANTED TO BE A RESOURCE FOR QUESTIONS AND ANSWERS. HOPEFULLY WE'LL HAVE PLENTY OF TIME FOR QUESTIONS AND ANSWERS AND FOR MONA AND MYSELF. THANK YOU FOR THE INTRODUCTION. IT'S IMPORTANT TO KNOW A TOUCH ABOUT MYSELF BEFORE WE TALK ABOUT THE STRONG HEART STUDY, I GREW UP IN NORTH DAKOTA, CLOSE TO CHAIRMAN JOHNSON, INDIAN HEALTH SERVICE AND PRIVATE CLINIC SEEING MANY SAME PATIENTS FOR TEN YEARS IN DUNSEITH, NORTH DAKOTA. I WORKED WITH THE STRONG HEART STUDY WITH MARSHAL O'LEARY AND OTHERS AT MISSOURI BREAKS IN 1998 AND TEACHING GENETICS AT TRIBAL COLLEGE IN TURTLE MOUNTAIN AROUND THE SAME TIME UNTIL WE MOVED TO WESTERN NORTH DAKOTA TO JOIN MY SON ON HIS RANCH THERE FIVE YEARS AGO. I'VE BEEN INVOLVED IN MANY RESEARCH STUDIES, OFTEN INVOLVING GENETICS AND TRIBAL COMMUNITIES. I SEE HERE THIS IS MAIN STREET OF OUR TOWN THAT WE LIVED IN FOR A LITTLE OVER -- MY POINTER IS NOT WORKING. YEAH, 20 YEARS IN WILLET. THIS IS THE HOSPITAL, ON THE BOTTOM IS THE TRIBAL COLLEGE IN BELCOURT. THE STRONG HEART STUDY -- I SHOULD MENTION I'M GOING TO SPEND A FAIR AMOUNT OF TIME TALKING ABOUT KIND OF THE HISTORY OF THE STRONG HEART STUDY. I DON'T THINK IT'S POSSIBLE TO REALLY UNDERSTAND THE WHOLE BUSINESS OF DATA SHARING WITHOUT HAVING A MORE COMPLETE KNOWLEDGE OF HOW THIS STRONG HEART STUDY DEVELOPED AND SO ON, SO PLEASE BEAR WITH ME FOR A LITTLE WHILE HERE WHILE WE GO INTO THAT FIRST. SO IT BEGAN IN 1988. WE RECRUITED 4500 PARTICIPANTS BETWEEN 45 AND 75 YEARS OF AGE, AND THREE BASIC AREAS UP IN THE DAKOTAS, IN OKLAHOMA, AND IN ARIZONA. THE ORIGINAL COHORT WAS REEXAMINED ON TWO FURTHER PHASES, AND A PILOT STUDY BEGAN IN 1998 TO RECRUIT ADDITIONAL FAMILY MEMBERS AS YOUNG AS AGES 16 AND ON UP IN LARGE FAMILY GROUPS WHICH ALLOWED A VERY POTENT GENETIC ANALYSIS TO BE CONDUCTED, SO ALL TOTAL AN ADDITIONAL 3600 INDIVIDUALS WERE INVOLVED IN THE FAMILY STUDY AND THERE'S BEEN ADDITIONAL PHASES SINCE THEN AND SURVEILLANCE HAS CONTINUED LOOKING PRIMARILY FOR CARDIOVASCULAR DISEASE OUTCOMES AND THE RISK FACTORS SUCH AS DIABETES THAT FEED INTO THAT RISK. SO I HOPE MY POINTER IS WORKING. THERE WE GO. SO WE LIKE TO THANK AND I THINK IT'S TRUE THERE'S MANY DEFINITIONS OF COMMUNITY-BASED PARTICIPATORY RESEARCH, CBPR, BUT YOU DON'T SEE MANY REFERENCES UNTIL AROUND 1988, AND I THINK EVEN THOUGH WE DIDN'T HAVE A NAME FOR IT AT THAT TIME THAT WAS WHAT WE WERE PRACTICING. WE INTENSIVELY ENGAGED WITH THE COMMUNITIES RIGHT FROM THE START, AND BESIDES ASSISTING THE RECRUITMENT I MENTIONED, AND SO MAINTAINING A VERY HIGH RETENTION LEVEL OF OVER 7,000 INDIVIDUALS OVER MULTIPLE EXAMS, WE ALSO ASSISTED IN THE TRAINING OF SOME 50 -- OVER 50 AMERICAN INDIAN YOUNG INVESTIGATORS, TO ATTAIN ADVANCED DEGREES AND WE'RE AMONGST THE FIRST TO REALLY INCORPORATE GENETIC ANALYSIS INTO A LARGE POPULATION-BASED STUDY IN INDIAN COMMUNITIES. SOME INDIVIDUALS INVOLVED IN THE EARLY HISTORY YOU CAN SEE HERE DR. EVERETT RHODES CHIEFING RECOGNITION AT THE TOP THERE, FORMER DIRECTOR OF THE INDIAN HEALTH SERVICE, AND REALLY CRITICAL TO THE ESTABLISHMENT OF THIS STRONG HEART STUDY AND NEXT TO HIM TO HIS RIGHT YVETTE RUBIDOUX, ALSO TRAINED ON THE STRONG HEART STUDY DATA. THROUGH THE HELP OF DR. SPERO MANSON AND OTHERS AT THE UNIVERSITY OF COLORADO IN DENVER WORKED WITH THE STRONG HARD STUDY, YVETTE IS DIRECTOR AT THE INDIAN HEALTH SERVICE AS WELL, YOU CAN SEE THE GENERATIONAL TRANSITION AND CHANGES AND IMPACT THE STRONG HEART STUDY HAD ON MANY LIVES. DR. FABSITZ WAS THE ORIGINAL PROJECT OFFICER FOR STRONG HEART STUDY UNTIL DR. PUGGAL TOOK HIS PLACE A FEW YEARS AGO. ONE OF THE WAYS WE'VE MAINTAINED THIS CLOSE CONNECTION WITH THE COMMUNITIES IS BY HAVING OUR MEETINGS IN THE COMMUNITY ITSELF. SO UP IN THE UPPER LEFT THERE YOU'LL SEE A GROUP OF US INVESTIGATORS AND SO ON HAVING A STEER COMMITTEE MEETING IN EAGLE BEACH AT THE MISSOURI BREAKS OFFICE. TO THE RIGHT YOU'LL SEE MARSHAL O'LEARY, HERE ALSO, HERE FOR ONE OF OUR LAST MEETINGS AS WELL, INSTRUMENTAL IN DEVELOPING MISSOURI BREAKS. RIGHT LOWER CORNER LILLIAN BROWN IS ONE OF THE ORIGINAL RECRUITERS, COMMUNITY MEMBER AND PARTICIPANT IN STRONG HEART WITH SOME OF HER FAMILY. ANOTHER ONE OF OUR MEETINGS THIS TIME IN OKLAHOMA, YOU SEE DR. RHOADES IN THE BACKGROUND AT THE COMMUNITY MEET BE, UPPER RIGHT, AND DR. FABSITZ ON THE LOWER RIGHT YOU'LL SEE SOME MUCH YOUNGER-LOOKING STRONG HEART STUDY INVESTIGATORS BACK IN THE OLD DAYS AT FIELD HEALTH OFFICES IN OKLAHOMA. I DON'T HAVE ANY PICTURES UNFORTUNATELY FROM ARIZONA, BUT SAME THINGS WERE OCCURRING THERE. MOST RECENTLY ABOUT A YEAR AGO THIS FALL, WE MET NAP SAN ANTONIO AND INVITED MANY COMMUNITY MEMBERS TO COME TO SEE THE GENETIC ANALYSIS FACILITIES WE HAD A BLESSING CEREMONY IN JULY. YOU SEE A PICTURE FROM THAT. ONE OF THE KEY FEATURES OF STRONG HEART HAS BEEN OUR INVOLVEMENT OF THE YOUNG AMERICAN INDIAN INVESTIGATORS, AND THIS IS JUST A RELATIVELY SMALL SAMPLE. DR. JOLLY, ALASKA NATIVE, TOOK OVER MY POSITION AT THE DAKOTA CENTER A COUPLE YEARS AGO. DR. HENDERSON WHO YOU KNOW WELL FROM THIS COMMITTEE, CEO OF THE BLACK HILLS CENTER FOR AMERICAN INDIAN HEALTH, DR. DORSCHER, ASSISTANT DEAN AND INVOLVED WITH US, JASON DEEN IS PEDIATRIC CARDIOLOGIST, BLACK FOOTE MEMBER, AND DR. VERNEY AND DR. FRETTS FROM THE UNIVERSITY OF WASHINGTON. WE RECRUITED AND OBTAINED FUNDING FROM NATIONAL INSTITUTE OF HEART, LUNG AND BLOOD FOR MINORITY SUPPLEMENT TO THE STRONG HEART STUDY, THIS IS FOR CAITLIN LAWRENCE, SECOND-YEAR STUDENT AND MEDICAL LAB TECHNICIAN TECHNOLOGY AT THE UNIVERSITY OF MARY IN BISMARK, WORKED AT MISSOURI BREAKS AS SUMMER INTERN, EXTENDING RECRUITS. TO INVESTIGATE PRE-ECLAMPSIA AND WE'VE OBTAINED ADDITIONAL INSTRUMENTS FOR ADDITIONAL GENETIC ANALYSIS AT EAGLE BUTTE ITSELF. IMPACT OF STRONG HEART HAS BEEN A NUMBER OF AREAS BUT IN TERMS OF PUBLIC HEALTH WE'VE CONFIRMED RELEVANCE OF THE FRAMING HAM RISK FACTORS IN THE AMERICAN INDIAN POPULATION. I USED TO HEAR, WELL, YES, MAYBE TOBACCO, SMOKING IS NOT GOOD FOR NON-INDIAN BUT FOR INDIANS DOESN'T HAVE THE SAME EFFECT AND WE UNDERSTAND THE RELIGIOUS SIGNIFICANCE OF TOBACCO, BUT I THINK FROM STUDIES FROM STRONG HEART WE CAN SAY NO, BIOLOGICALLY, THE RISK FACTORS HAVE THE SAME EFFECT AS THEY DO FOR NON-INDIANSIAN. WE DEVELOPED THE EQUIVALENCE OF DIABETES AND FOUND HIGH PREVALENCE OF STROKE AND AMERICAN INDIAN POPULATION AS WELL AS HIGH PREVALENCE OF VENTRICULAR HYPERTROPHY IN YOUTH AND DEVELOPING NUTRITION AND PHYSICAL ACTIVITY BASELINE DATA, IMPACT ON STANDARDS OF CARE. IT'S HELPED TO INFORM ATP 3 GUIDELINES THAT CLINICIANS USE INCLUDING DIABETES AS A CVD EQUIVALENT, THE SANDS STUDY WHICH DR. HENDERSON WAS VERY MUCH INVOLVED IN WAS AN OUTGROWTH OF STRONG HEART STUDY, PROVIDING EVIDENCE RELATED TO EFFECTS OF AGGRESSIVE LIPID AND BLOOD PRESSURE MANAGEMENT, THE FRAMINGHAM RISK SCORES WERE REEVALUATED SPECIFICALLY FOR STRONG HEART COMMITTEE, AND FOUND TO BE SOMEWHAT -- NEEDED TO BE SOMEWHAT MODIFIED, INCORPORATES INTO THE ELECTRONIC HEALTH SYSTEM WORD AS WELL AS WEBSITE AND DEVELOPED IMPORTANT EVIDENCE OF ALBUMURAI AS A CHIEF RISK. ONE CHIEF RISK TO CONNECTIONS HAS BEEN TRANSLATION, HUMANITY TO TRANSLATE RESEARCH FINDINGS INTO CLINICAL PRACTICE, HERE YOU SEE DR. TOM WELTY AND HIS WIFE, AND GEORGE STARR, PHYSICIAN ASSISTANT IN WANBLEE IN SOUTH DAKOTA. WE'RE DOING A PRESENTATION ABOUT STRONG HEARTS STUDY, HOW THEY MIGHT BE USEFUL TO CLINICIANS IN THAT AREA. HERE YOU SEE A GROUP OF HIGH SCHOOL STUDENTS MEETING RECENTLY AT THE THIRD ANNUAL RESEARCH CONFERENCE, IN EAGLE BUTTE SPONSORED BY MISSOURI BREAKS, AND HERE WE'RE TELLING THEM ABOUT EPIDEMIOLOGY IN GENERAL, GENETICS, BIOMEDICAL RESEARCH, ENCOURAGING THEM TO THINK ABOUT CAREERS AS CLINICIANS OR RESEARCHERS. I THINK ANOTHER GOOD EXAMPLE OF TRANSLATION HAS BEEN OUR EFFORTS THANKS TO DR. CHRISTINE GEORGE, NAVAS AND YRACHETA, WITH LEVELS OF ARSENIC IN GROUND WATER AND PRIVATE WELLS, RURAL WATER SYSTEM, THE PUBLIC WATER SYSTEM WHICH MOST TRIBAL MEMBERS NOW USE IS COMPLETELY WITHIN EPA GUIDELINES, BUT THESE PRIVATE WELLS ARE NOT NECESSARILY. SO WE'VE ENTERED INTO THIS TO FURTHER EDUCATE AND INFORM PEOPLE ABOUT THIS ISSUE SO THEY CAN TAKE STEPS INCLUDING INSTALLATION AND MAINTENANCE OF A FILTER SYSTEM THAT CAN REMOVE THE ARSENIC SO WE'RE STILL IN THE PROCESS OF THIS AND LEARNING HOW TO DO THIS BETTER, BUT THIS IS A GOOD EXAMPLE OF THE ORIGINAL EMPTIVE, IT'S BEEN KNOWN FOR A LONG TIME ARSENIC IS NOT GOOD FOR YOU. UNTIL FIVE OR SIX YEARS AGO IT WAS NOT KNOWN THEY HADED ADVERSE EFFECTS, INFORMATION COMING FROM THE STRONG HEART STUDY TO A CONSIDERABLE EXTENT. DR. LONNIE NELSON AT UNIVERSITY OF WASHINGTON WORKING WITH DR. BUCHWALD, SPOUSE OF SPERO MANSON, AND THEY HAVE BEEN DOING THE FITSMI STUDY TO REDUCE RISK FACTORS FOR STROKE FLOOR MOTIVATION, IMPROVING BLOOD PRESSURE CONTROL, SMOKING. DR. VERNEY WORKING TO IMPROVE REHABILITATION AFTER STROKE AND OTHER SERIOUS NEUROLOGIC INJURIES. DR. FRETTS IS MIKMAQ, UNIVERSITY OF WASHINGTON, WORKING AT CHEYENNE RIVER, THE CRCAIH PROGRAM FUNDED THROUGH NIH MINORITY HEALTH AND HEALTH DISPARITIES, DEVELOPED PILOT, LOOKS LIKE SHE WILL HAVE A GOOD CHANCE OF HAVING FURTHER FUNDING THROUGH THE RO1 MECHANISM. SO THESE -- THE IMPACT AND INFORMATION FROM STRONG I THINK HAS BEEN IMPORTANT TO TRIBAL LEADERS AND HEALTH DIRECTORS, THIS HAS BEEN COMMUNICATED THROUGH HHS MEETINGS AND COUNCIL MEETINGS THROUGH PUBLICATION REVIEW WHICH IS PART OF OUR PROCESS, THE DATA BOOK WHICH WAS DEVELOPED EXPLAINING THE EPIDEMIOLOGIC FINDINGS OF THE STRONG HEART STUDY IN LAY TERMS, HAS BEEN USEFUL FOR LOBBYING EFFORTS. AND I THINK THE DATA HAS ACTUALLY BEEN CRITICAL FOR OBTAINING FUNDING FOR THE SDPI PROGRAM, JUST SPEAKING WITH COUNCILMAN JOHNSON EARLIER WORKING IN THE PROGRAM, TALKING ABOUT HUNDREDS OF MILLIONS OF DOLLARS A YEAR TO HELP MANAGE AND CONTROL DIABETES IN INDIAN COUNTRY AND WE'VE STARTED TO SEE POSITIVE INFLUENCES FROM THAT DECREASING THE RATE OF END STAGE RENAL DISEASE AS WELL AS RETINOPATHY. THIS IS VERY ENCOURAGING NEWS. ALSO INCREASING OVERALL KNOWLEDGE OF RESEARCH, HOW IT'S ORGANIZED, BENEFITS AND RISKS THROUGH PUBLICATION REVIEW, PROPOSED APPROVAL PROCESS, COLLABORATION WITH NEIGHBORS, INVESTIGATORS AND TRAINING TRIBAL MEMBERS OF COURSE PUBLIC INFORMATION HAS BEEN PROVIDED THROUGH OPEN MEETINGS AND IRBs, AND GLOBAL ISSUES SUCH AS DATA SHARING. WE'RE GOING TO TALK ABOUT DATA SHARING. WE'LL GET TO THAT. SHARING DOESN'T COME EASY. RESEARCHERS ARE HUMAN AND GUILTY OF NOT NECESSARILY WANTING TO SHARE. AT TIMES THERE'S BEEN HOARDING OF DATA. SOMETIMES IT'S LOST TO THE FUTURE, THERE'S BEEN NO PLANS FOR DISTRIBUTION AND SO ON. ON THE OTHER HAND, THE NIH REALIZED IF THEY HAD EVERYONE SHARE DATA THE MINUTE THEY GOT IT THEY WOULDN'T HAVE ANYONE COLLECTING DATA. THEY WOULD HAVE EVERYONE ANALYZING AND WRITING PAPERS SO THEY PUT IN POLICIES IN PLACE TO GIVE THOSE WHO COLLECT THE DATA FIRST AT REPORTING IT AND PUBLISHING IT. DATA SHARING IS A NO-BRAINER IN THE SENSE THE MORE EYES WE HAVE ON THE DATA IT SHOULD INCREASE RATE OF PROGRESS SO MANY ORGANIZATIONS ENDORSED IDEA, INSTITUTE OF MEDICINE, WELLCOME TRUST, BILL AND MELINDA GATES, ET CETERA, IT'S BEEN OFFICIAL POLICY SINCE AT LEAST 2003 AND THE ATTEMPT IS OBVIOUS. LET'S TALK ABOUT THE HISTORY OF DATA SHARING. IN 2004 WORKBOOK POINTED OUT IMPORTANCE OF IMPLICATIONS AND ISSUES. ONE HAVING TO DO WITH PROTECTION OF PARTICIPANTS' IDENTITIES, POSSIBILITY OF SOCIAL OR COMMUNITY HARMS FROM STIGMATIZATION AND WHAT CONSTITUTES SENSITIVE INFORMATION MAY VARY BY CONTEXT AND TIME. NIH HAS ASKED ALL RESEARCHERS ESSENTIALLY IN MOST CASES TO PROVIDE THEIR DATA TO BE AVAILABLE AROUND A YEAR AFTER COLLECTION, AGAIN GIVING SOME TIME FOR THE ORIGINAL COLLECTORS TO ANALYZE AND REPORT. THIS WAS THOUGHT ENOUGH TIME TO COMPLETE THAT. AND THE STRONG HEART STUDY HAS DEVELOPED DATA SHARING PLANS ACCEPTABLE IN COLLABORATION WITH THE TRIBE, AND WE BEGIN TO DISCUSS THE OVERALL ISSUE AND SOME IMPLICATIONS, MORE DETAILED IMPLICATIONS TO TRIBAL COUNCILS ON THIS ISSUE AS EARLY AS 2004. AND THERE'S A PICTURE AT PRAIRIE NIGHTS IN NORTH DAKOTA IN 2006, DISCUSSING IMPLICATIONS OF DATA SHARING FOR TRIBAL COMMUNITIES.. SINCE THEN THERE HAVE BEEN PRESENTATIONS. UNTIL THE LAST YEAR OR SO THERE'S BEEN LITTLE ACTIVE ENGAGEMENT ON THE PART OF THE INDIAN ORGANIZATIONS, TRIBAL GOVERNMENTS AROUND THIS ISSUE, AND I'M GLAD TO SEE THERE'S BEEN IMPORTANT CHANGES RECENTLY THANKS TO DR. WILSON AND MANY OTHERS AROUND THE ROOM HERE. I THINK SOME OF THE NATIONAL ORGANIZATIONS LIKE THE NATIONAL CONGRESS OF AMERICAN INDIANS HAS BEEN VERY ACTIVE IN THIS WAY TOO. SO FROM THE STRONG HEART STUDY PERSPECTIVE WE'VE BEEN ENGAGED IN DATA SHARING SINCE THE BEGINNING. WE INSIST ON TRIBAL APPROVAL OF ALL PUBLICATIONS, IT'S BEEN OVER 400 OF THEM, ESSENTIALLY NO DELAY OR HOLDUP IN PROVIDING APPROVAL FOR PUBLICATION OF THE FINDINGS, COLLABORATIONS WITH OTHER INVESTIGATORS HAVE GONE ON FROM INVESTIGATORS AROUND (TECHNICAL DIFFICULTIES, PLEASE STAND BY) THE DIFFICULTY HAS BEEN FINDING THAT ENGAGEMENT THAT INVOLVEMENT FROM TRIBAL LEADERS AND GOVERNMENT. AND INITIALLY WE OUTLINED SOME CONSIDERATIONS FOR TRIBAL LEADERS TO THINK ABOUT INCLUDING OBVIOUSLY TRIBAL SOVEREIGNTY AND POTENTIAL COMMUNITY HARMS, THE SMALL NUMBERS AND SOME COMMUNITIES THAT MAKE CONFIDENTIALITY DIFFICULT, TRIBAL IDENTIFICATION IS ESSENTIALLY ASSURED, MOST PEOPLE KNOW WHAT TRIBES WERE INVOLVED OR CAN EASILY FIND OUT, MANY OF THE TRIBAL RESOLUTIONS HAVE ASSERTED OWNERSHIP OF DATA, THINKING PERHAPS MORE ALONG THE LINES OF FUTURE THERE MIGHT BE INSTITUTIONS THAT WOULD BE ABLE TO DISTRIBUTE THE DATA WITH PROPER SAFEGUARDS TO TRIBAL INTERESTS AND IF TRIBES TOOK THEIR DATA BACK AND HOLD IT TO THEMSELVES IT WOULD HAVE RELATIVELY LITTLE USEFULNESS BECAUSE MOSTLY NUMBERS WOULD BE SMALL, POWER WOULD BE GREATLY LIMITED. THINGS WERE GOING ALONG MORE OR LESS IN A STABLE FASHION, IN REGARDS TO STRONG HEART UNTIL THE GENOME-WIDE ASSOCIATION TECHNOLOGY, THESE DEVELOPMENT OF THESE GENE CHIPS, ANALYZING HUNDREDS OF THOUSANDS OF SMALL GENETIC CHANGES AT ONE WHACK WERE DEVELOPED, AND THESE WERE EXPENSIVE AT THE TIME, AND NIH MADE THE DECISION THAT ANY FUNDING THAT THEY PROVIDED FOR THIS TECHNOLOGY WOULD HAVE TO INCLUDE DATA SHARING IN PUBLIC FORUM SUCH AS DATABASE dbGAP WHICH WOULD BE ACCESSIBLE TO ANYONE IN THE WORLD BASICALLY WITH SOME RESTRICTIONS THROUGH DATA USE COMMITTEE NOT INVOLVING TRIBAL INPUT. AS A RESULT WHAT WE APPLIED FOR GWAS FUNDING FOR STRONG HEART, OUR PROPOSAL WAS NOT ACCEPTED, AND IT DIDN'T STATE ON THE RESPONSE THAT THIS WAS NOT ACCEPTED BECAUSE DATA SHARING BUT IT WAS CLEAR FROM INFORMAL CONVERSATIONS THAT WAS THE ISSUE. IT WAS THE MAIN ISSUE. AND OTHER COHORT STUDIES WERE FUNDED FOR THIS, WHICH DID INCLUDE DATA SHARING AS NIH DESIRED. FURTHER CLAPPATIONS WITH CALICO AND PAGE WERE -- COLLABORATIONS WERE AFFECTED. THERE'S BEEN A SIMILAR IMPACT ON COOPERATION WITH THE TOP MED STUDY WHICH HAS BEEN MORE RECENT. SO TO MAKE MATTERS A LITTLE MORE DIFFICULT, WE FEEL THAT THE NIH POLICY ON DATA SHARING HAS BEEN SOMEWHAT INCONSISTENT SO SOME OF THE INSTITUTES LIKE NIDDK SEEM TO BE WILLING TO PROVIDE A WAIVER ON DATA SHARING AND STRONG HEART PARTICIPATED IN THE FIND STUDY. NHGRI WAS INVOLVED WITH THE POSSIBLE COLLABORATION FOR THE PAGE STUDY, AND WE WERE NOT INCLUDED IN THE END BECAUSE THEY WERE NOT ABLE TO PROVIDE A GUARANTEE THE WAIVER WOULD BE FORTHCOMING ON DATA SHARING. AGAIN, NHLBI WAS -- STRONG HEART WAS NOT INCLUDED IN THE MAJOR GENOME-WIDE SEQUENCING INITIATIVE, AGAIN PROBABLY AT LEAST PARTLY ON THE BASIS OF THE DATA SHARING ISSUE. SO LIKE MOST GOOD PEOPLE, IF THERE'S A BARRIER, A CHALLENGE, YOU TRY AND FIGURE OUT A WAY TO GET AROUND IT. AND SO STRONG HEART DID THE SAME THING, INVESTIGATORS BEGAN TO THINK, WELL, IF ONE INSTITUTE IS MORE FAVORABLE, MAYBE WE COULD GO THERE FOR FUNDING RATHER THAN OTHERS, SO THAT'S CREATED SOME EFFORTS ALONG THAT LINE. THERE WAS INITIALLY SORT OF A GAP IN THE DATA SHARING REQUIREMENTS THAT ALLOWED CERTAIN STUDIES TO BE DONE ON A FOCUSED AREA OF THE GENOME INSTEAD OF LOOKING AT THE ENTIRE GENOME YOU COULD LOOK AT ONE PARTICULAR GENE, AND SO SOME -- ONE STUDY WAS CONDUCTED IN THAT WAY. PRIVATE FUNDING HAS ALLOWED TO US DO SOME ADDITIONAL DATA COLLECTION, BUT THE AMOUNT OF MONEY THAT'S AVAILABLE IS NOT VERY GREAT. AND THEN IN 2015 THE NIH FURTHER EXPANDED THEIR DATA SHARING REQUIREMENTS, TIGHTENING THE LOOPHOLE, IF YOU WILL, ON THE GENE FOCUSED ANALYSES AND SO THIS HAS MADE IT MORE DIFFICULT. BESIDES TRYING TO WORK AROUND SOME OF THESE, WE HAVE LOOKED AT SOME INNOVATION, AND ONE OF THOSE IS THE IDASH PROGRAM. THE IDEA IS TO DEVELOP AN I.T. PLATFORM THAT WOULD ALLOW THE STRONG HEART DATASET TO BE ACCESSED REMOTELY WITHOUT ANY ABILITY TO COLLECT OR LOOK AT THE RAW DATA, BUT SIMPLY TO DO ANALYSES ON IT. WE'VE EXPLORED THIS WITH TRIBAL REPRESENTATIVES, THEY HAVE BEEN ACCEPTABLE OR AMENABLE TO THAT. IN ADDITION WE'RE LOOKING WITH UNIVERSITY OF NORTH DAKOTA INMET PROGRAM TO DEVELOP AN EXPEDITED ACCESS WITH ANONYMIZED DATASETS. SOME PEOPLE MIGHT SAY SO WHAT IF INDIAN PEOPLE ARE NOT INVOLVED IN GENETIC STUDIES DOES IT MAKE A DIFFERENCE? I THINK IT DOES MAKE A DIFFERENCE. I'M SOMEWHAT BIASED ON THE SUBJECT BUT MOST OF THE INFORMATION WE HAVE CURRENTLY ABOUT GENETIC POPULATION DATA COMES FROM THE CENTRAL AMERICA AND SOUTH AMERICA, NOT NORTH AMERICAN INDIAN POPULATION. AGAIN, SOMEONED MIGHT SAY IF WE DISCOVER SOMETHING WE CAN JUST APPLY IT LATER TO INDIAN PEOPLE. IT'S NOT AS SIMPLE. THERE ARE CERTAIN GENETIC CHANGES THAT HAVE DIFFERENT EFFECTS IN INDIAN PEOPLE DEPENDING ON OTHER GENES AND OTHER PARTS OF THE GENETIC CODE AND ALSO IN TERMS OF THE ENVIRONMENT. THE OTHER THING A LOT OF PEOPLE DON'T UNDERSTAND IS A TEST THAT WORKS IN ONE POPULATION WITH A CERTAIN PREVALENCE OF DISEASE DOES NOT NECESSARILY WORK PROPERLY IN ANOTHER POPULATION WITH A DIFFERENT PREVALENCE, AND SO UNLESS YOU KNOW THE PREVALENCE OF SOME OF THESE CHANGES THESE GENETICS CHANGES ARE NOT GOING TO BE ABLE TO KNOW WHETHER A PARTICULAR GENETIC TEST IS USEFUL OR HARMFUL IN A DIFFERENT POPULATION. THE JOURNALS JUMPED ON BOARD. WE'VE HAD DIFFICULTIES OCCASIONALLY WITH JOURNALS INSISTING WE DEPOSIT OUR DATA, RAW DATA IN A REPOSITORY AVAILABLE TO EVERYONE. THEY HAVE CHOSEN PUBLIC OR INSTITUTIONAL. WE'VE MAINED STRONG HEART REPOSITORY IS EQUALLY AS AVAILABLE. INVESTIGATORS CAN EXPLAIN AND ARE GENERALLY APPROVED, BUT THE JOURNALS HAVE NOT ALWAYS BOUGHT ON AND ASSERTED THE OTHER REPOSITORIES ARE MORE PERMANENT, EVEN THOUGH OURS BEGAN IN 1988, OTHERS ARE YOUNGER. THE GENETIC CONVERSATION CHANGED GREATLY I THINK WITH THE BOOK "THE IMMORTAL CELLS OF HENRIETTA LACKS," TREATED FOR CERVICAL CANCER IN 1951 AT JOHNS HOPKINS. MANY SURROUNDING INSTITUTIONS AT THAT TIME REFUSED TO TAKE CARE OF BLACK PEOPLE BUT A PORTION MUCH CERVICAL BIOPSY WAS USED TO CULTURE HUMAN CELLS AND IN HER CASE TURNED OUT IT WORKED, AND THEY BECAME IMMORTALIZED. THERE'S MULTIPLE QUESTIONS ABOUT THE CONSENT, THIS WAS AT A TIME WHEN CONSENT WAS VERY RUDIMENTARY COMPARED WITH TODAY. AND JUST IN A FEW YEARS AGO NIH RELEASED THE WHOLE GENOME SEQUENCE OF THE HeLa CELL LINE, RESULTING IN CONSIDERABLE CONTROVERSY FROM THE LACKS FAMILY AND NIH REVISED THEIR POSITION TO ALLOW INCLUSION OF MEMBERS OF THE LACKS FAMILY. WE BEGAN TO SENSE A SHIFT IN THE WIND ABOUT 2014. WE FELT SOME TENTATIVE OUTREACH FROM CERTAIN INSTITUTES. THERE SEEMED TO BE INTEREST IN DIRECT COMMUNICATION WITH TRIBAL LEADERS WHICH WE ADVOCATED ALL ALONG, AND THERE'S INCREASED RECOGNITION I THINK OF THE SOVEREIGNTY OF TRIBAL GOVERNMENTS AND I POINT TO THE MOST RECENT CHANGES, DEVELOPMENTS IN TERMS OF THE SINGLE IRB THAT'S RECOMMENDED HERE, RECENT CHANGES FOR THE COMMON RULE, WHICH RECOGNIZED AUTHORITY OF TRIBAL GOVERNMENTS I THINK TO MAKE MODIFICATIONS IN THAT POLICY. IN TERMS OF THIS PARTICULAR COMMITTEE, THIS WAS STARTED OF COURSE IN 2014. AND SOME OF THE INFORMATION SAID PURSUANT TO EXECUTIVE ORDER FROM 2000, PRESIDENTIAL MEMORANDA OF 2004, 2009, AND THEN TO DEVELOP AND ENSURE TRIBES HAVE TIMELY INPUT, SOMEHOW THE TIME SPAN BETWEEN 2000 AND 2014 DOESN'T SEEM COMPLETELY TIMELY TO ME BUT MAYBE IT DOES TO OTHER PEOPLE. I'D LIKE TO TAKE A COUPLE MINUTES TO WRAP UP. THIS IS MORE OF MY PERSONAL OPINION BUT HAVING TO DO WITH THE OVERALL STATE OF PRIVACY, THOSE OF US WHO CARRY CREDIT CARDS AND USE THE INTERNET, EQUIFAX BREACH IS THE MOST RECENT IN A SERIES OF WHO KNOWS HOW MANY, HUNDREDS OF MILLIONS OF PEOPLE'S PRIVATE INFORMATION LOST TO HACKERS AND REITERATES THE POSITION OF MANY TRIBAL MEMBERS HOW CAN WE TRUST AND GUARANTEE OUR INFORMATION REMAINS PRIVATE, AND I TAKE THAT REALLY PESSIMISTIC VIEW THE AGE OF PRIVACY IS OVER. NONE OF US HAVE PRIVACY ANYMORE. THAT'S AN EXTREME VIEW BUT THAT'S MY OPINION. NOT ONLY JUST PRIVACY BUT A FEW YEARS AGO FACEBOOK WASN'T SATISFIED TO DO OBSERVATIONAL RESEARCH. THEY DECIDED TO DO SOME INTERVENTION ON ABOUT 600,000-SOME PEOPLE, TESTING TO SEE WHETHER THEY COULD ALTER PEOPLE'S EMOTIONS BY THEIR FACEBOOK FEEDS. TARGET ORGANIZATION IS ABLE TO FIGURE OUT WHEN YOU'RE PREGNANT EVEN BEFORE YOUR FATHER DOES. AND SO THERE'S ALL KINDS OF THINGS THAT HAVE BEEN OCCURRING IN TERMS OF FORENSICS, DNA EVIDENCE HAS BEEN COLLECTED SURREPTITIOUSLY AND WITHOUT CONSENT, K-MART TRASH CAN, A PIZZA HUT CUP FROM AN UNDERCOVER DETECTIVE OF DEET. TWITTER IS PREVIOUSLY -- INITIALLY ALLOWED ONLY ABOUT A 1% OF TWEETS TO BE ANALYZED, BUT IN 2006 THIS OPENED IT UP AND THIS IS CONSIDERED A PUBLIC SPACE WHERE OBSERVATION IS ALLOWED AND THEY SUGGEST INVESTIGATORS NEVER REAL SCREEN NAMES BUT THIS IS PROBABLY NOT NECESSARILY HAPPENING. IN ADDITION, BIOBANK MOVEMENT, IS GAINING LOTS OF STEAM, INCLUDING FROM THE FEDERAL GOVERNMENT, AND NOT ALL OF THEM USE CONSENT, MANY USE ANONYMIZED SAMPLES, MOST -- ALMOST ALL THE CONSENTS FOR BIOBANK ARE VERY GENERAL, WHICH THEY SHOULD BE IN MY MIND. THERE'S BEEN USE OF NEONATAL BLOOD SPOTS WITHOUT CONSENT FOR A NUMBER OF YEARS. THIS IS CHANGING NOW BUT HOSPITAL PATHOLOGY SPECIMENS REMAIN AVAILABLE AND IN THE MOST RECENT ATTEMPT TO REVISE COMMON RULE THE CHANGE IN USE OF ANONYMIZED SAMPLES WAS NOT ACCEPTED. AND YOU HAVE ORGANIZATIONS LIKE THE CYST CYSTIC FIBROSIS TO USE THE BIOBANK, $2 BILLION IN ROYALTIES, MANY WHILE PATIENTS MANY OF WHOM BELONG TO THIS CYSTIC FIBROSES ARE CHARGED UP TO $300,000 A YEAR FOR THE MEDICATION. I'M NOT NECESSARILY SAYING ALL THESE THINGS ARE BAD, JUST TRYING TO POINT OUT I THINK OUR CONCEPTS OF PRIVACY AND CONFIDENTIALITY ARE GREATLY CHANGED, AND I DON'T THINK THERE'S ANY TURNING BACK, I DON'T THINK WE CAN PUT THE CAT BACK IN THE BAG. THAT'S ALL I HAVE TO SAY. I APPRECIATE YOUR TIME AND ATTENTION AND WOULD BE HAPPEN TO TRY AND RESPOND TO QUESTIONS WITH DR. PUGGAL. [APPLAUSE] >> : THANK YOU FOR THE PRESENTATION. IT DOES SPEAK TO WHERE WE FIND OURSELVES, A FOOT IN BOTH WORLDS THERE, BECAUSE YOU VERY SUCCESSFULLY ARTICULATED WHAT SOME CONCERNS ARE WITH PRIVACY, AND, YOU KNOW, AS WE LISTEN TO OUR ELDERS OF COURSE, IT WAS A LOT OF SOCIAL STIGMATIZATION, AND GENERALIZATION ABOUT TRIBAL PEOPLE, AND SO TYPICALLY LOATHE TO SHARING IN. E A N Y T HING. ON THE OTHER HAND I'VE BEEN USING DATA TO ADVOCATE ON THE HILL, THE MOST RECENT EXAMPLE IS SDPI, SPECIAL DIABETES PROGRAM, WE'VE USED STATISTICS. YOU THINK ABOUT OMB AND PEOPLE DOING BUDGETING, YOU'VE GOT TO USES STATISTICS, SO WE USE INDIVIDUAL INFORMATION IN TERMS OF HERE'S A STORY TO TELL YOU ABOUT HOW THIS HAS AFFECTED OUR COMMUNITY BUT WE HAVE TO USE THE STATISTICS AS WELL TO MAKE THAT BUDGETARY ARGUMENT FOR THE FUNDING THAT WE'RE SEEKING. SO I DON'T KNOW WHERE THAT MIDDLE GROUND IS NECESSARILY, BUT I DO THINK IT'S IMPORTANT FOR US TO THINK ABOUT IT, AND TO THINK ABOUT WAYS THAT WE CAN PARTICIPATE IN RESEARCH AND PARTICIPATE IN DATA SHARING THAT MAKES SENSE, BUT THAT RESPECTS OUR TRIBAL COMMUNITIES, BECAUSE ONE OF THE THINGS WE WORRY ABOUT IS ONE MOHICAN SAYS I WANTS TO BE IN THE STUDY IS THAT GENERALIZED TO ALL, AND IF ONE CONSENTS DOES THAT MEAN ALL CONSENT TO RESEARCH? I'VE BEEN PARTICIPATING IN THE NURSES STUDY, GETTING THE DATA BACK TO SAY HERE IS WHAT WE LEARNED, THERE'S VALUE IN THAT. I THINK THE QUESTION IS HOW DO WE WALK THAT LINE. I AGREE WITH YOU THERE'S NO PRIVACY ANY LONGER. WHEN I WAS VETTED FOR THE TREASURY ADVISORY COMMITTEE ALL MY INFORMATION WAS HACKED SO NOW THEY ARE MONITORING MY CREDIT. >> : JUST TO BRIEFLY COMMENT, I THINK ALL OF US HAVE TO MAKE TRADEOFFS. YOU KNOW, THERE'S NOTHING IN THIS WORLD THAT'S BLACK AND WHITE. YOU CAN MAKE AN EASY DECISION, WHETHER YOU DECIDE TO BE ON FACEBOOK, WHICH I DON'T, OR WHETHER YOU DECIDE TO TAKE A PART IN RESEARCH, WHICH I DO, PERSONALLY, IT'S JUST SOMETHING YOU HAVE TO DECIDE, WELL, HOW MUCH DO I WANT, HOW MUCH DON'T I WANT. HOW DOES IT FIT. >> : DAMNED IF YOU DO, DAMNED WHEN YOU DO. [LAUGHTER] WE HAVE -- YES, MALEA? >> THANK YOU SO MUCH FOR THAT REALLY INSIGHTFUL AND TO LEARN MORE ABOUT THE GENEALOGY OF WHAT HAS COME BEFORE IS REALLY HELPFUL. JUST A COUPLE THOUGHTS. FIRST IS THAT DATA BOOK IS INTRIGUING. I WAS TEXTING WITH DR. DEAN, CAN WE FIND A WAY TO GET A COPY TO NCI OR AROUND A GROUP BECAUSE I THINK THAT'S REALLY A BIG PART OF THE PIECE BUT REALLY IN LINE WITH LOBBYING EFFORTS, SITTING HERE IN SOME NEW CAPACITY AROUND LOBBYING AND HOW WE'RE USING DATA BUT IN TERMS OF INDUSTRY ROLE, I WORK FOR NATIVE CORPORATION IN THE DAY JOB, ON THE HILL LOBBYING AROUND BROWN FIELD CLEANUP AND EPA AND HOW OUR NATIVE CORPORATIONS IN ALASKA AND OTHER SMALL BUSINESSES HAVE CAPACITY AND CAPABILITY TO DO THAT CLEANUP BUT WHEN YOU PUT UP WITH THE SLIDE WITH DOCTORS NAVIS, ASEA AND GEORGE HOW DO HE WE BRING INDUSTRY WITH SCIENCE CAPACITY AND THE VALUE THAT CAN ADD TO THE COMMUNITIES, SO THERE'S A WAY FOR US TO CONNECT ON SOME OF THAT I WOULD REALLY APPRECIATE THAT PACE. THERE'S ONE OTHER ABOUT THIS MIDDLE GROUND, WHAT IS THAT MIDDLE GROUND BEYOND THE SPACE OF PRIVACY? FOR ME IT'S ALWAYS A POINT WHETHER WE COME BACK TO THE ETHICS, RIGHT? IF WE AGREE THAT WE'RE BEYOND THE POINT WHERE THINGS ARE PRIVATE, HOW DO WE THEN DETERMINE A SET OF GUIDELINES AND ETHICS THAT GUIDE OUR DECISION MAKING ABOUT THE PROPER USE OF DATA SO IN A LOBBYING CONTEXT WHEN YOU'RE ADVOCATING ON BEHALF OF PEOPLE, GIVING CONSENT, AM I GIVING CONSENT FOR MYSELF OR ENTIRE COMMUNITY, IT'S THAT AND THAT'S WHERE THIS COMMITTEE HAS A REAL ROLE AND FUNCTION TO PLAY IN CONNECTION WITH OTHERS WITH THE ETHICS, I APPRECIATE YOU BRINGING THAT TO THE FORE AND THANK YOU FOR THAT. >> : I WANT TO SAY SOMETHING ON THAT. YOU KNOW THE COMPONENT THAT WE DEAL WITH AS TRIBAL LEADERS IS THE POLITICAL COMPONENT. AND SO WE SEE INDUSTRY, WE SEE SCIENCE, AND OUTSIDE THE NATIVE COMMUNITY WE SEE HOW THAT INTERMINGLES WITH LOCAL GOVERNMENTS OR AGENCIES, EVEN ELECTIONS, YOU KNOW? AND WE ALWAYS -- THE GENERAL POPULATION, GENERAL SOCIETY WILL USE THE FRONT OR DEAL AS BACK DROP OF PUBLIC HEALTH AND RESEARCH AND HOW THINGS WERE CORRUPTED, BUT WE DEAL WITH THE TRIBAL LEVEL DAILY. WE HAVE LITTLE SCENARIOS THAT GO ON DAILY BECAUSE OF THAT LACK OF CAPACITY. AND SO I THINK THE POINT YOU TOUCHED ON WAS CAPACITY BUILDING ACROSS THE BOARD FOR TRIBAL COMMUNITIES, BUILDING THAT CAPACITY. AND THE ONLY WAY WE DO THAT IS WITH PARTNERSHIPS. TRUE PARTNERSHIPS, PEOPLE WHO HAVE THAT SINCERE -- AND NOT IN THE EXPLOITIVE SENSE TO GET PUBLISHED OR MAKE A PROFIT OR TO GET RE-ELECTED, BUT TO REALLY IMPACT OUR COMMUNITIES IN A POSITIVE WAY. I THINK THAT'S WHAT THIS IS. THAT'S WHY IT'S CALLED STRONG HEART. YOU'RE ABLE TO BRIDGE THOSE. AND I THINK THE MAJOR PIECE THERE IS BEING ABLE TO GROW OUR OWN, BEING ABLE TO INSPIRE AT THE LOCAL LEVEL THOSE WHO CAN GO ON TO SOMETHING THAT WE'D NEVER THINK AN INDIAN WOULD GIVE IN TO, SOMETHING WITH WATER, SOMETHING WITH SCIENCE. I MEAN, WE'RE DEALING WITH THAT AT THE NORTHERN CHEYENNE RIGHT NOW AND WHEN YOU MENTIONED THE RURAL HEALTH WATER SYSTEMS, THE WELLS AND SEPTIC TANKS THAT WE DEAL WITH IN IHS FUNDING FOR THAT WE HAVE NO MONITORING OF OUR WELL WATER. WE HAVE IT FOR OUR SYSTEMS SO WE ARE TAKING THE STEPS BECAUSE A YOUNG LADY GOT EDUCATE AND SAID IT MIGHT BE A GOOD IDEA TO START MONITORING OUR WELLS. THAT WAS MIND BLOWING FOR THE TRIBAL COUNCIL, WOW, WE HAVE TO THINK ABOUT THINGS LIKE THIS. AND SO I FIND WHAT YOU'RE SAYING VERY RELEVANT AND I WANT TO GIVE MY APPRECIATION FOR WHAT SHE COMPILED, DATA SHARING. I KNOW THE CATCH PHRASE NCI AND YOUR GROUP HAS DONE WITH RESEARCH IS DATA SOVEREIGNTY. TOO OFTEN IN THE PAST AS A FORMER TRIBAL LEADER WE WERE COMING HERE WITH ANECDOTES, AND ONLY IN THE LAST, YOU KNOW, FEW YEARS HAVE WE BEEN ABLE TO BE MORE SOPHISTICATED IN INCLUDING THE DATA LIKE THE CHIEF SAID IN HER CONSULTATIONS, IN LISTENING SESSIONS AND ADVOCACY EFFORTS. SO THIS IS A REALLY, REALLY INSPIRATIONAL AND COMPELLING PROGRAM YOU HAVE GOING THERE. IT'S CLOSE TO HOME. WE HAVE THE SAME CONDITIONS AND CAPACITY AND CIRCUMSTANCES. IS THERE ANY MORE QUESTIONS? YES, MR. PHELPS? >> THANK YOU, LYLE. CAN YOU GO BACK THROUGH YOUR FOURTH SLIDE, WHICH SHOWS THE SIX PHASES. IN LOOKING AT THIS, IT'S NOTICEABLE THAT THERE WAS CHANGES WITH EACH PHASE DURING THOSE PERIODS OF THE STUDY, WHERE THE NUMBERS OF FAMILIES THAT WERE BEING STUDIED BETWEEN PHASE 3, PHASE 4, THE NUMBERS INCREASED AND PHASE 5 EVEN MORE SO. SO THESE ARE MY QUESTIONS. HOW DID THEY UPDATE AND ALTER THE INFORMED CONSENT INCLUDING WHEN GENETIC COMPONENT WAS ADDED, HOW WERE THE FAMILIES RECRUITED AND DID THE INDIVIDUAL FAMILY MEMBERS FEEL PRESSURED TO PARTICIPATE? WHAT KIND OF INCENTIVES WERE PROVIDED TO PARTICIPANTS AND WHAT APPLICATIONS OR FINDINGS HAVE BEEN GIVEN TO PARTICIPATING TRIBES? >> THANK YOU VERY MUCH FOR THAT QUESTION. JUST TO CLARIFY A LITTLE BIT, THERE'S ONLY BEEN ONE CHANGE IN THE TOTAL NUMBER OF PARTICIPANTS, AND THAT WAS BETWEEN PHASE 3 AND 4 WHEN ADDITIONAL FAMILY MEMBERS WERE RECRUITED. WITH EACH OF THESE PHASES, THERE WAS TRIBAL APPROVAL FOR THAT UPCOMING PHASE, AND THERE WAS ALSO A SEPARATE CONSENT FORM FROM THE INDIVIDUAL AT EACH PHASE. AS FAR AS, YOU KNOW, PRESSURING OF FAMILY MEMBERS, I GUESS I DON'T KNOW OF ANY WAY TO COMPLETELY AVOID THAT SORT OF FEELING A FAMILY MIGHT HAVE IF ALL ADDITIONAL FAMILY MEMBERS ARE PARTICIPATING. I REALLY CAN'T THINK OF A GOOD WAY TO AVOID THAT, THAT POSSIBLE PRESSURE. THE AMOUNT OF INCENTIVES, MARSHA COULD HELP ME BUT WE'RE TALKING ABOUT $25 IN GENERAL, IN THAT NEIGHBORHOOD. THERE WERE ADDITIONAL ANCILLARY STUDIES, FOR EXAMPLE, STRONG HEART STROKE STUDY WHERE WE DID MRI, BRAIN MRI SCANS, THIS INVOLVED EXTENSIVE TRAVEL, YOU KNOW, A COUPLE HUNDRED MILES. I THINK INCENTIVES WERE LIKE $300 BUT FOR GENERAL PARTICIPATION IT'S BEEN QUITE MINIMAL, IT SEEMS MINIMAL TO ME AT LEAST. IN TERMS OF RETURNING INFORMATION ABOUT THE STUDY, WE DID RETURN INFORMATION TO THE INDIVIDUAL PARTICIPANTS IN TERMS OF THEIR BLOOD PRESSURE, YOU KNOW, HEALTH ADVICE IN TERMS OF STOPPING SMOKING, CONTROLLING THEIR CHOLESTEROL AND THINGS SUCH AS THAT. IN TERMS OF THE TRIBAL RETURN OF INFORMATION, THIS HAPPENS PRIMARILY THROUGH THE PUBLICATION REVIEW, AND BESIDES PROVIDING A COPY OF THE ACTUAL PUBLICATION, WE PROVIDE A SUMMARY GENERALLY A PAGE OR LESS IN LAY TERMS, OUTLINING THE GENERAL FINDINGS AND HOW IT MIGHT BE APPLICABLE TO PUBLIC OR CLINICAL PRACTICE, PUBLIC HEALTH OR CLINICAL PRACTICE. IN ADDITION WE DO HAVE COMMUNITY MEETINGS, AND SO ON, TO FURTHER DISSEMINATE AND DISTRIBUTE THE INFORMATION ABOUT THE FINDINGS. >> : THANK YOU. A FOLLOW-UP QUESTION, SO IF I RECALL CORRECTLY, THERE WAS A PHOENIX AREA STUDY WITH THE STRONG HEART STUDY, BUT NOT ON NAVAJO, RIGHT? NONE DONE ON NAVAJO. SO IS THERE A WAY THAT THE PROJECT CAN SHARE YOUR DATA SHARING CONSENT PROTOCOLS AND INFORMATION ON YOUR POLICY THAT YOU'VE DEVELOPED SO FAR WITH EACH OF THE PROJECTS AREAS THAT YOU'VE DEVELOPED? I ASSUME YOU HAVE ONE POLICY THAT MAYBE YOU USE BUT MAYBE IT'S A LITTLE UNIQUE AND TWEAKED FOR EACH COMMUNITY. CAN YOU TOUCH ON THAT TOO. IF YOU CAN SHARE THAT INFORMATION WITH US AT NAVAJO THAT WOULD BE VERY HELPFUL. THANK YOU. >> YOU'RE MORE THAN WELCOME TO THE INDIVIDUAL CONSENT FORMS. WE DO HAVE A GENERAL POLICY ON DATA SHARING AND DATA USE THAT'S ALSO AVAILABLE ON THE WEBSITE BUT I CAN POINT THAT OUT TO YOU. NAVAJO IS NOT A PART OF THE ORIGINAL STRONG HEART STUDY BUT I BELIEVE OR THE FOLLOW-UP STUDIES, BUT I BELIEVE THERE WAS A SITE AT NAVAJO INVOLVED WITH THE STAND STUDY. IS THAT CORRECT, MARSHA? WITH EARTH. I WAS THINKING IT MIGHT HAVE BEEN SANDS AS WELL. I GUESS NOT. OKAY. >> CHESTER? GO AHEAD, DOCTOR. >> I TOLD LYLE I'LL TALK FROM THE PROGRAMATICS PERSPECTIVE, I JUST WANTED TO INFORM YOU NHLBI IS COMMITTEED, THEY RECOGNIZED THE IMPORTANCE OF THE STUDY. AS YOU SEE HERE, THE CURRENT PHASE OF THE STUDY WILL BE OVER NEXT YEAR, AND WE ARE COMMITTED IN THE SENSE WE'RE GOING TO -- IT'S GOING TO BE OUT IN TWO OR THREE WEEKS BUT WE'RE GOING TO HAVE REQUESTS FOR PROPOSAL SO BASICALLY STRONG HEART WILL BE FUNDED FOR ANOTHER SEVEN YEARS VIA CONTRACT MECHANISM. AND IF ANYONE HAS QUESTIONS, WE CAN TALK ABOUT THAT OFFLINE. >> IF I HEARD YOU RIGHT, YOU MENTIONED SOMETHING ABOUT A WAIVER DURING YOUR PRESENTATION. WHAT WAS THAT ONE ABOUT? REFRESH MY MEMORY. >> RIGHT. THERE WAS A MECHANISM IN THE NIH DATA SHARING, AS I UNDERSTAND IT, POLICY, THAT ALLOWED FOR A WAIVER IN CERTAIN CIRCUMSTANCES. AND STRONG HEART STUDY DID APPLY FOR A WAIVER, AND THERE WAS A REQUEST FROM I'M QUITE SURE AT LEAST ONE TRIBAL GOVERNMENT IN THE DAKOTAS AND ONE IN OKLAHOMA AREA, BASICALLY A WAIVER WAS NOT GRANTED AT THAT TIME. I DON'T THINK THERE WAS MUCH OF AN EXPLANATION OF WHY IT WAS NOT GRANTED, JUST THE ANSWER WAS NO, WON'T BE A WAIVER. >> YEAH, ONE OF THE QUESTIONS IS TO AT LEAST, WHERE WE'RE SITTING AT, TO DISCUSS THAT WAIVER AND WHETHER OR NOT ANY GRANTS -- I KNOW THEY ARE INCLUDED BUT ONLY IF IT'S A DETRIMENT TO PUBLIC HEALTH AND NATIONAL SECURITY AND ALSO THE EXTRAORDINARY CIRCUMSTANCE. SO IF SOMEONE COULD ELABORATE ON THAT OR AT SOME POINT BEFORE WE LEAVE THE MEETING BECAUSE WHAT YOU JUST DISCUSSED EARLIER ON INFORMED CONSENT HAVE QUESTIONS BECAUSE OF THE "ALL OF US" INITIATIVE, AND SO THAT'S A CURRENT SITUATION. IF WE COULD AT SOME POINT, I KNOW IT'S STRICTLY THE STRONG HEART STUDY BUT THOSE QUESTIONS ARISE AND WILL ARISE THROUGHOUT THE NEXT -- TODAY AND TOMORROW. >> DR. WILSON? >> THANK YOU. SO DR. HULL WILL BE TALKING ABOUT THAT SPECIFIC ISSUE IN HER PRESENTATION COMING UP. >> DENISE? >> SO PERHAPS THAT WILL BE ADDRESSED IN THE NEXT PRESENTATION BUT I GUESS I WAS JUST LOOKING AT THIS KIND OF INCONSISTENT APPLICATION KIND OF ACROSS NIH INSTITUTES, AND I KNOW THAT THERE'S NOT NECESSARILY AN NIH-WIDE POSITION. I THINK AT THIS POINT IN TERMS OF DATA SHARING, WHAT IT INVOLVES INDIGINOUS GROUPS, IS THAT WHAT WE'RE WORKING TOWARDS? OR IS THE VARIABILITY ACROSS INSTITUTES, IS THAT -- I GUESS I'M JUST -- WHAT ARE THE SOLUTIONS TO THAT? OR ARE THERE GOING TO BE INSTANCES WHERE IT NEEDS TO BE A POLICY SPECIFIC PER INSTITUTE OR LIKE WHAT ARE WE WORKING TOWARDS HERE? WHAT ARE THE POTENTIAL SOLUTIONS? IT SEEMS LIKE THE INCONSISTENT APPLICATION IS CONCERNING BECAUSE IT SEEMS LIKE THE ETHICAL ISSUES WOULD BE SIMILAR. >> THAT'S A VERY GOOD QUESTION THAT I DEAL WITH EVERY DAY, BEING THE DIRECTOR OF THE OFFICE OF COORDINATION. [LAUGHTER] SO YES. >> (INAUDIBLE). >> NIH HAS 27 INSTITUTES AND CENTERS, NOT ALL FUND RESEARCH BUT HISTORICALLY HAD VARIATION IN DETERMINING POLL SIVMENT POLICY. WE'RE HERE TO AGREE ON NIH APPROACH. WE HAVE KEY PEOPLE. FRANCIS OF COURSE, AND THIS IS A GOOD THING TO BRING UP WITH HIM TO BRING UP, ALSO THE DIRECTOR OF OUR EXTRAMURAL RESEARCH OFFICE, MIKE LAUER, WILL BE HERE TODAY. PLEASE BRING THIS ISSUE UP WITH HIM. >> . ANY OTHER QUESTIONS OR COMMENTS? NO? ALL RIGHT. GOOD JOB. [APPLAUSE] >> I GUESS WE'LL TAKE OUR BREAK NOW. SO YOU'RE EXCUSED. IT'S NOT A HALF AN HOUR BREAK. STILL 15-MINUTE BREAKS. >> YOU HAVE TO COME BACK. NEXT WE HAVE THE NAVAJO NATION INSTITUTIONAL REVIEW BOARD PRESENTATION AND DISCUSSION. AND BRIEFLY, I'M GOING TO GIVE YOU BACKGROUND WHILE THEY ARE GETTING READY OR WHATEVER THEY NEED TO DO AND GIVE A BRIEF BACKGROUND ON THEM. IF I MISPRONOUNCE YOUR NAME CORRECT ME WHEN YOU SAY IT, OKAY? BEVERLY BECENTI PIGMAN, SHE HAS INVOLVED IN A NUMBER OF TRIBAL GOVERNMENT COMMITTEES REGARDING HEALTH INCLUDING NATIONAL TRIBAL STEERING COMMITTEE ON INJURY PREVENTION, HAS HAD EXPERIENCE WORKING DIRECTLY WITH LOCAL TRIBAL GOVERNMENT SYSTEMS AS PAST SECRETARY-TREASURER FOR CAYENTA CHAPTER AND JUDGE FOR STATE OF ARIZONA NAVAJO COUNTY. WE ALSO HAVE DR. DAVID BEGAY, CURRENTLY ASSOCIATE RESEARCH PROFESSOR WITH THE UNIVERSITY OF NEW MEXICO ALBUQUERQUE, IN THE ENVIRONMENTAL HEALTH PROGRAM, AND AT UNIVERSITY OF ARIZONA FLAGSTAFF, MEMBER AND ADVISER TO A SPIRITUAL HILLERS ASSOCIATION WITH NAVAJO NATION, MEMBER OF THE NAVAJO NATION HUMAN RESEARCH REVIEW BOARD. PLEASE FORGIVE ME IF I BUTCHERED ANYTHING BUT THANK YOU FOR US THIS MORNIN G. >> THAT'S OKAY. (INAUDIBLE). >> I'M GOING TO USE THAT ONE. [LAUGHTER] >> I LOVE PLAY GAMES IN NAVAJO. AGAIN, AS WE WERE INTRODUCED, I JUST WANT TO SAY THAT I USED TO SIT ON THE NAVAJO AREA HEALTH BOARD, AND THEY WANTED TO A REPRESENTATIVE OF THE IRB BOARD. I GOT TO THINKING, MOST OF THE IRB MEMBERS ON IHS WERE GONE, I THOUGHT WHY, I'M A NAVAJO MOTHER, A GRANDMOTHER, AND I KNOW THERE ARE NAVAJO PHYSICIANS, NURSES, THERAPISTS, ALL KINDS OF NAVAJOS THAT HAVE DIFFERENT ABILITIES TO SIT ON THE BOARD LIKE THIS, AND I SAID I'D LIKE TO REQUEST THE BOARD TO LOOK AT THE MEMBERS OF THE -- MEMBERSHIP OF THE IRB, AND I EXPLAINED TO THEM, I SAID, WITH& ALL DUE RESPECT, I APPRECIATE THE WORK THAT YOU ALL HAVE DONE BUT THERE ARE NAVAJO PROFESSIONALS THAT ARE OUT THERE THAT SHOULD BE SITTING AROUND THIS TABLE AND DECIDING WHAT IS NEEDED FOR THEIR COMMUNITY. SO I HAD THE OPPORTUNITY TO, THINKING ABOUT THIS, LOOKING AT THE FEDERAL RULES AND REGULATIONS, I MET WITH THEN-PRESIDENT ALBERT HALE, WHO IS A SENATOR NOW FOR ARIZONA AND TOLD HIM, YOU NEED TO 638 THE IRB FROM IHS, YOU'RE NOT GETTING ANY DATA AND WE REALLY NEED IT. SO AFTER SOME DISCUSSION WITH THE DEPARTMENT OF JUSTICE, THEN HE SAID, WE WILL 638 IT, AND THEN I MET WITH THE HEALTH OVERSIGHT COMMITTEE FOR THE TRIBAL COUNCIL, AND EXPRESSED MY CONCERNS ABOUT THAT, SO THEY BOTH WENT AHEAD AND 93-638, AND I WAS TOLD SINCE YOU'RE STARTING THIS WE WANT YOU TO WORK WITH THE DEPARTMENT OF JUSTICE TO DEVELOP THE LAWS, RULES AND REGULATIONS THAT WILL OVERSEE THIS AND YOU'LL BE HOUSED IN THE DEPARTMENT OF DEPARTMENT OF HEALTH. I WAS FORTUNATE TO HAVE THE NAVAJO NATION DEPARTMENT OF JUSTICE WORK WITH ME AND WE DEVELOPED POLICIES AND PROCEDURES. AND SO THEN WE GOT MEMBERSHIPS TO THE IRB BOARD, AND ONE OF THEM WAS THE MEDICINE MAN WHO SAT THERE IN OUR MEETINGS AND WE TALKED ABOUT RESEARCH, AND THAT WAS WHAT HAPPENED WHEN THE BEGINNING OF THE NAVAJO NATION IRB CAME IN TO BEING. SO I JUST WANT TO SAY THAT IT'S BEEN A REMARKABLE ERA AND WE'VE REALLY -- I CAN TRULY SAY WE'VE BENEFITED FROM RESEARCH. FOR EXAMPLE, THEY WERE DOING A VACCINE FOR BABIES, AND JOHNS HOPKINS WAS DOING THE STUDY, AND AT THE END OF THE STUDY WHEN THEY WERE NEARING THE END OF IT, I SAID IT WOULD BE GREAT IF I -- IF JOHNS HOPKINS WOULD GIVE THE NAVAJO NATION AS A GIFT ALL OF THE VACCINE TO INOCULATE ALL THE BABIES ON NAVAJO, AND YOU KNOW WHAT JOHNS HOPKINS GAVE IT TO THE NAVAJO NATION. SO THESE HAVE BEEN SOME REAL SUCCESSES, AS FAR AS THE NAVAJO NATION HUMAN RESEARCH REVIEW BOARD. AND BELIEVE ME, WHEN I GO AFTER SOMETHING, I GO AFTER IT FULL SPEED, OVERDRIVE, BECAUSE I FIRMLY BELIEVE THAT WE HAVE THAT ABILITY TO TAKE CARE OF OUR OWN THINGS, AND IN ADDITION I WAS A JUSTICE OF THE PEACE FOR NAVAJO COUNTY, AND I ALSO PLACED ALL THE DIALYSIS UNITS ON THE HOPI RESERVATION, NAVAJO NATION, AND THE SIOUX IN SOUTH DAKOTA, SO I WAS ABLE TO HELP THEM GET A DIALYSIS. AND IHS NOR DID THE TRIBE HAVE TO PUT ANY MONEY TO IT. I HAPPENED TO READ UP ON A DIALYSIS COMPANY AND WENT TO MEET WITH THEM AND TOLD THEM WE HAVE A REAL NEED HERE. I SAID IF YOU WILL PUT A DIALYSIS UNIT IN CAYENTA I WILL HOLD YOUR HAND THROUGH THE PROCESS AND HELP YOU WHATEVER NEEDS TO BE DONE, SO THE BOARD WENT INTO EXECUTIVE SESSION AND THEN THEY DECIDED THAT THEY& WOULD GO AHEAD AND GO INTO THAT, SO WE HAVE DIALYSIS UNITS ON NAVAJO. THERE'S BEEN GREAT WONDERFUL THINGS THAT HAPPENED. THE MISSION OF THE NAVAJO NATION RESEARCH PROGRAM IS TO SUPPORT RESEARCH THAT PROMOTES AND ENHANCES THE INTERESTS AND THE VISIONS OF THE NAVAJO PEOPLE, ENCOURAGE A MUTUAL AND BENEFICIAL PARTNERSHIP BETWEEN THE NAVAJO PEOPLE AND RESEARCHERS, AND TO CREATE AN INTERFACE FOR DIFFERENT CULTURES, LIFESTYLES, DISCIPLINE AND IDEOLOGY CAN COME TOGETHER IN A WAY THAT IMPROVES, PROMOTES AND STRENGTHENS THE HEALTH OF THE NAVAJO PEOPLE. AND IT BEGAN IN OCTOBER 1995, WAS WHEN I PRESENTED LAWS, RULES AND REGULATIONS TO THE 88 COUNCIL MEMBERS FOR NAVAJO NATION, AND THEY APPROVED THOSE LAWS, SO THEN WE WENT BACK IN 2002 AND UPDATED AND AMENDED THOSE LAWS SO WE ARE IN THE PROCESS OF DOING IT. WE MEET EVERY MONTH, THE THIRD TUESDAY OF THE MONTH, AND ON A CONSISTENT BASIS BECAUSE WE'VE GOT A LOT OF REALLY DEDICATED IRB MEMBERS THAT SIT ON THE BOARD. AND WE'VE DEVELOPED RELATIONSHIPS WITH ACADEMIC INSTITUTIONS LIKE UNM, NAU, U OF A, JOHNS HOPKINS, UNIVERSITY OF UTAH, DENET COLLEGE, AND CROWN POINT TECHNICAL COLLEGE, AND WE HAVE CONFERENCES EVERY TWO YEARS AND WE WILL BE HAVING OUR CONFERENCE THIS YEAR ON SEPTEMBER THE -- I'M SORRY, OCTOBER 17th AND 18th IN WIND ROCK. AND SO WE REALLY REQUIRE THAT THE RESEARCHER AT THE UNIVERSITY SELECT A NAVAJO COLLEGE STUDENT AND HAVE THAT INDIVIDUAL BE A CO-P.I. SO THAT STUDENT CAN LEARN ABOUT RESEARCH AND BEGIN TO DO RESEARCH STUDIES ON THAT FOR THE NAVAJO NATION, AND SO THAT'S REALLY WORKED OUT REAL GREAT WITH US. AND WE HAVE A LOT OF -- WE ONLY APPROVE YEARLY PROTOCOLS FOR ONE YEAR. IF YOU'RE GOING TO GO BEYOND TWO YEARS, THEN YOU HAVE TO ASK FOR AN AMENDMENT AND SO THEN WE ADD ANOTHER YEAR TO IT. AND WE MAKE SURE THAT THE DATA ALL COMES BACK TO THE NAVAJO NATION. AND IN ADDITION, IF A RESEARCHER GETS A FEDERAL GRANT, THE EQUIPMENT THAT THE RESEARCHER BUYS WITH THOSE FEDERAL DOLLARS, THAT EQUIPMENT GOES BACK TO THE THE STUDY. SO WE GET THAT KIND OF THINGS FOR OUR COMMUNITIES TO ENHANCE THEIR ABILITY, AND IN ADDITION A RESEARCHER HAS TO HELP THE COMMUNITY TO BE ABLE TO FUND THOSE SERVICES. WE HAVE THE RESEARCHER MEET WITH THE MEDICAL STAFF OF IHS FACILITIES AND NON-IHS FACILITIES TO IN-SERVICE THEM DURING THE TIME THAT THEY ARE DOING THEIR RESEARCH PROJECT TO ENSURE THAT THE INFORMATION GETS BACK TO THE MEDICAL STAFF SO THEY WILL BE ABLE TO HANDLE PATIENTS IN A MORE RESPECTFUL MANNER. AND SO THEN WE HAVE AGAIN, AS I SAID, WE HAVE A RESEARCH CONFERENCE, AND THE PURPOSE OF THE CODE WAS TO SET FORTH THE CONDITIONS UNDER WHICH INVESTIGATORS, PHYSICIANS, RESEARCHERS AND OTHERS MAY PERFORM HEALTH AND HEALTH-RELATED RESEARCH ACTIVITIES, WITHIN THE TERRITORIAL JURISDICTION OF THE NAVAJO NATION. AND IT'S A POLICY FOR THE NAVAJO NATION TO ENSURE THAT ALL PERSONS WITHIN THE TERRITORIAL JURISDICTION OF THE NAVAJO NATION ARE FREE FROM UNREASONABLE HARMFUL, INTRUSIVE, ILL-CONCEIVED OR OTHERWISE OFFENSIVE RESEARCH AND INVESTIGATION PROCEDURES, SO WE DO NOT APPROVAL STUDIES UNLESS THERE IS A CONSENT FORM. WE MAKE SURE THAT THERE'S A CONSENT FORM, AND WHAT NEEDS TO HAPPEN IF SOMEONE GETS HURT DURING THE STUDY AND SO WE MAKE SURE THAT WE MONITOR THAT. I'M GOING TO TURN IT OVER TO DAVID FOR COVERING THE BELMONT REPORT. WE HAVE 15 MEMBERS OF THE IRB. >> I ASSUME MOST OF YOU -- WHEN IT COMES ON RED DOES THAT MEAN -- OKAY. OKAY. I ASSUME MOST OF YOU KNOW ABOUT THIS REPORT. WE FOLLOW THE PRINCIPLES AND THE VALUES AND THE GUIDELINE OF THIS REPORT, AND IT'S IN OUR NAVAJO NATION CODE. IT'S A LAW OF THE NAVAJO NATION. ALSO, WITHIN THE CODE THERE'S A SECTION ON WHAT WE CALL THE FUNDAMENTAL LAW, WHERE IT TAKES INTO CONSIDERATION THE TRADITIONAL LAW, THE OLD TRADITIONAL LAW OF THE NAVAJO PEOPLE. IN THERE, THIS IS ALSO CITED, AND ALL THESE THINGS THAT ARE UP THERE, NO HARM WILL COME TO THE RESEARCHERS, AND RESPECT, JUSTICE, THAT'S MENTIONED, ALL OF THAT, IT'S ALREADY WRITTEN INTO THE FUNDAMENTAL LAW, AS A MATTER OF FACT EVEN BEFORE THIS REPORT HAS BEEN PART OF THE TRADITIONAL LAW AND SO IN SO MANY DIFFERENT WAYS THIS IS -- THESE THINGS WRITTEN UP HERE, ETHICAL PRINCIPLES AND GUIDELINES ARE CLOSELY FOLLOWED. >> WE HAVE THREE PERSONS APPOINTED BY THE NAVAJO AREA HEALTH BOARD, THREE APPOINTED BY THE OFFICE OF THE NAVAJO NATION PRESIDENT, THREE APPOINTED BY THE TRIBAL COUNCIL OVERSIGHT COMMITTEE, AND THREE PERSONS APPOINTED BY THE NAVAJO NATION COUNCIL EDUCATION COMMITTEE, AND THREE PERSONS APPOINTED BY THE NAVAJO AREA INDIAN HEALTH SERVICE DIRECTOR. SO THAT'S HOW THE IRB MEMBERS ARE SELECTED. WHAT DID YOU DO TO IT? [LAUGHTER] >> LET ME JUST QUICKLY JUMP ON THIS ONE. HERE ON THE RIGHT SIDE IS DR. KEVIN WHITE, ALSO A MEMBER OF OUR BOARD. HE'S MAKING A REPORT ON THE IRB TO THE FORMER PRESIDENT OF THE NAVAJO NATION DR. JOE SHIRLEY SO WE FREQUENTLY GIVE REPORTS AND INTERACT WITH THE EXECUTIVE ADMINISTRATION OF THE NATION. AND ALSO HERE IS A TRIBAL COUNCIL IN SESSION, THE PERSON SITTING WAY BACK THERE, THAT'S GIVING THE REPORT, IS DR. TAYLOR MCKENZIE. HE'S ONE OF OUR NAVAJO PHYSICIANS. HE'S GIVING A REPORT TO THE NAVAJO NATION COUNCIL ON HEALTH-RELATED ISSUES. SO WE FREQUENTLY INTERACT WITH THE NAVAJO NATION COUNCIL, ESPECIALLY SUBCOMMITTEE, THE NAVAJO EDUCATION HEALTH AND HUMAN SERVICE COMMITTEE. >> AND THEN NOW WE GO TO THE 12-STEP PROCESS. ONE, THE FIRST THING A P.I. DOES IS SUBMIT AN ABSTRACT SO THAT -- AND PRESENT IT TO THE IRB BOARD, AND WE REVIEW IT, AND WE'LL HAVE OUR STAFF SEND IN AN APPLICATION TO COMPLETE. AND ONE OF THE THINGS THAT WE DO IS WE REQUIRE THE RESEARCHER TO GO TO THE COMMUNITY, EVEN GETTING ELDERLY INDIVIDUALS OR MEDICINE MEN TOGETHER BECAUSE ON NAVAJO, OUR ELDERS AND OUR MEDICINE MEN ARE THE NAVAJOS' ENCYCLOPEDIA. THEY HAVE ALL THE INFORMATION THAT IS NECESSARY. SO WE GO AHEAD AND HAVE THEM MEET WITH THE COMMUNITY AND TALK ABOUT THE STUDY, EVEN HELP THE RESEARCHER DEVELOP THE QUESTIONS AND THE CONSENT AND HOW THAT COMMUNITY FEELS IT WOULD BE CUSTOMIZED TO THE NEEDS OF THE CHAPTER, WE ALSO HAVE THEM GO TO THE HEALTH BOARDS AND ANY COMMUNITY ORGANIZATION, IF THEY ARE GOING TO DO A STUDY IN THE PUBLIC SCHOOL, THEY WOULD GO TO THE PUBLIC SCHOOL BOARD AND ASK THEM FOR APPROVAL. SO WHEREVER THEY GO IN THE COMMUNITY, ANY ORGANIZATION THAT THEY WANT TO DO RESEARCH FOR, THEY HAVE TO GET APPROVAL AND SUBMIT A RESOLUTION WITH THEIR APPLICATION TO THE IRB. AND IN ADDITION, WE HAVE THE RESEARCHER WORK WITH, FOR INSTANCE, IF IT'S AN ISSUE, A STUDY DONE ON EPA OR ON ANIMALS OR ON EDUCATION, WE HAVE THEM MEET WITH THOSE INDIVIDUALS TO HELP THEM THROUGH THAT PROCESS, SO THAT THE RESEARCH PROJECT IS REALLY CUSTOMIZED TO THE NEEDS AND THE ISSUES WITHIN A COMMUNITY. AND THEN WE HAVE THE P.I., ONCE THEY COMPLETED, GOTTEN THEIR RESOLUTIONS, THEIR HEALTH BOARD REPORTS, OR WHATEVER ENTITY THAT THEY ARE GOING TO BE WORKING WITH, WE HAVE THEM SUBMIT THE APPLICATION AND THEN WE REVIEW IT. AND WE SET A MEETING TIME, WHICH IS THE THIRD TUESDAY OF EACH MONTH, WHERE THE RESEARCHER HAS TO PRESENT THEIR PROTOCOL, AND THEN THE IRB MAKES A DECISION WHETHER TO APPROVE IT, HAVE IT AMENDED, OR MAKE ANY CHANGES TO THAT, TO THE PROCESS, AND APPROVAL OF THE APPLICATION. AND WE ALSO HAVE THEM PRESENT THAT TO THE HEALTH BOARDS AND THE COMMUNITIES, ALMOST ON A QUARTERLY BASIS ABOUT WHAT'S GOING ON, ON THEIR STUDY SO THAT THE COMMUNITY BECOMES A PARTNER IN THE WHOLE PROCESS AND IT HELPS THE RESEARCHER TO UNDERSTAND THAT SOVEREIGNTY IS NOT JUST AN ECONOMIC PROCESS OR POLITICAL PROCESS, BUT IT'S ALSO A PROCESS BY WHICH YOU WORK WITH YOUR COMMUNITY MEMBERS BECAUSE IT'S THEIR MINDS AND THEIR THOUGHTS THAT ARE GOING TO BE ABLE TO BE A PART OF DEALING WITH THAT PARTICULAR HEALTH OR EDUCATIONAL ISSUE. AND THEN WE SEND THEM A LETTER TELLING THEM THAT THEY ARE PERMITTED TO DO THAT, AND THEY HAVE A ONE-YEAR APPROVAL PROCESS, AND THEY ALSO HAVE TO PRESENT AT A RESEARCH CONFERENCE. AND WE FOUND THAT ONE OF THE STUDIES THAT WAS DONE WAS ABOUT OUR LUNCHES IN THE SCHOOLS ON NAVAJO. THEY DID THE PUBLIC SCHOOLS, THE CONTRACT SCHOOLS, THE GRANTS SCHOOLS AND BIA SCHOOLS AND FOUND THAT KIDS WERE NOT EATING VEGETABLES, THEY WERE EATING MORE OF THE THINGS THAT THEY SHOULDN'T HAVE AS OPPOSED TO A WELL-BALANCED MEAL. SO OUT OF THAT A CURRICULUM WAS DEVELOPED, AND THE PART OF THAT PROCESS WAS WORKING WITH THE FAMILIES AND THE TEACHERS IN THE CLASSROOM OF HOW TO HAVE THEIR CHILD MAKE BETTER DECISIONS REGARDING THE THINGS THAT THEY CONSUME. SO WE'VE BEEN ABLE TO DO THAT, AND THEN THE P.I. CONDUCTS A PRELIMINARY DATA ANALYSIS, AND HE PRESENTS THE FINDINGS TO THE NAVAJO NATION HUMAN RESEARCH REVIEW BOARD. AND OFTENTIMES WE'LL TELL THEM, YOU NEED TO GO TO EPA, YOU NEED TO GO TO IHS, THESE ENTITIES, AND TELL THEM YOUR FINDINGS AND SEE WHAT IS TAKING PLACE AND TO MAKE SPECIFIC RECOMMENDATIONS AS TO HOW THE TRIBE CAN IMPROVE THE SERVICES THAT THEY PROVIDE TO THE COMMUNITY, SO THAT HELPS A GREAT DEAL IN HAVING A COMMUNITY SERVE BETTER AS A RESULT OF RESEARCH. DO YOU WANT TO DO THE WORK SESSION? >> WE USUALLY ASK THE P.I. TO WORK WITH THE PEOPLE THAT THEY WANT TO WORK WITH, IN THE TRIBE, TRIBAL PROGRAMS, AND WE ASK THEM TO MEET WITH THE NAVAJO NATION DEPARTMENT OF HEALTH, AND ALSO TO PRESENT ALL REPORTS BACK TO THE NAVAJO NATION HUMAN RESEARCH REVIEW BOARD. AND SO WE CAN HAVE COMMUNICATION GOING BACK AND FORTH. >> AND ONCE A STUDY IS DONE, WE HAVE A FINAL REPORT, AND THEN THE P.I. BRINGS FORTH WITH THEM THE DATA OF THEIR STUDY. AND IF IT'S A UNIVERSITY OR ANY ORGANIZATION THAT IS PART OF THAT RESEARCH PROJECT, WE REQUIRE THAT THE UNIVERSITY OR ANY ORGANIZATION TO SUBMIT A NOTARIZED STATEMENT FROM THE COLLEGE IRB STATING THAT THEY HAVE NO DATA THAT THEY HAVE TURNED IT ALL OVER TO THE NAVAJO NATION, SO THAT'S TO ENSURE THAT THE NAVAJO NATION RECEIVES THE DATA AS IT'S SUPPOSED TO AND THEN OF COURSE THE EQUIPMENT THAT COMES WITH ANY FEDERAL GRANT PROTOCOLS THAT COME IN PLACE, AND NOW THAT WE'VE GONE THROUGH THIS PROCESS, THIS MAKES EVERYTHING MUCH MORE CUSTOMIZED AND IT HELPS THE NAVAJO NATION KEEP TRACK OF ANYTHING REGARDING STUDIES AND THEY ARE REQUIRED WITHIN 24 HOURS TO NOTIFY THE CHAIRPERSON ABOUT ANY INJURIES THAT TAKE PLACE. AND ONE OF THE THINGS THAT WE ARE FINDING OUT IS THAT THE SURROUNDING TOWNS AROUND THE PROTOCOL TO US BECAUSE THEY FEEL THAT IT'S OUT OF RESPECT AND UNDERSTANDING THAT THEY WANT TO SHARE THE DATA WITH THE NAVAJO NATION. SO WE ALLOW THEM TO DO THAT AND WE'RE ABLE TO GET MORE DATA EVEN FROM THE PUBLIC SCHOOLS OR BUSINESSES ON NAVAJO NATION. NOW, WHEN WE TALK ABOUT DATA SHARING, I HAVE TWO OR THREE QUESTIONS. ONE, WHY DOES NIH WANT DO DATA SHARING? TWO, NAVAJO NATION LAW REGARDING THE PRIVACY ACT IS NAVAJO LAW THAT COVERS THE JURISDICTIONAL TERRITORY OF THE NAVAJO NATION. SO WHEN YOU TALK ABOUT DATA OWNERSHIP, AND WHAT TAKES PRECEDENCE IS IT THE NIH LAW OR IS IT THE NAVAJO TRIBAL LAW THAT WOULD TAKE PRECEDENCE? AND I THINK THAT'S SOMETHING THAT AS NATIVE AMERICANS WE NEED TO MAKE SURE WE UNDERSTAND. AND ONE OF THE ISSUES THAT THINKING ABOUT NAVAJO, I THINK IT WOULD BE A GREAT THING IF NIH PROVIDED FINANCIAL ASSISTANCE TO THE NAVAJO NATION TO DEVELOP A DATA OWNERSHIP FACILITY SO THAT THE NAVAJO TRIBE WILL HAVE OWNERSHIP OF THE DATA, WILL BE ABLE TO CONTROL AND SECURE IT SO THAT NO ONE ELSE WOULD HAVE THAT INFORMATION, BECAUSE WE'RE TO THE POINT WHERE DATA SO VERY IMPORTANT IN EVERYDAY LIFE THAT WE WANT TO ENSURE THAT THE NATION HAS THE DATA AND THAT THE NATION CAN UTILIZE IT TO LOBBY FOR CERTAIN THINGS. SO I HAVE A QUESTION ABOUT TRIBAL LAW ON NAVAJO. IS THE PRIVACY ACT MORE IMPORTANT THAN THE HIPAA ACT? AND THOSE ARE ISSUES THAT NEED TO BE DISCUSSED WHEN YOU'RE TALKING ABOUT DATA SHARING. >> YEAH. TRY TO ADD TO THAT, WE'RE A BOARD. MOST OF THE PEOPLE ON THE BOARD ARE NON-TRIBAL EMPLOYEES. FOR EXAMPLE, I NEVER WORKED FOR THE TRIBE. WE'VE WORKED FOR THE UNIVERSITIES AND SOME OF THE FEDERAL AGENCY, RIGHT NOW I'M WORKING WITH NASA RIGHT HERE AT GODDARD SPACE FLIGHT CENTER, BEEN WORKING WITH THEM FOR 15 YEARS. SO I HAVE THESE OUTSIDE WORK THAT I'VE BEEN DOING PROFESSIONALLY ALL MY YEARS. WITH THE EXCEPTION OF TWO PEOPLE ON THE BOARD ALL OTHERS ARE WORKING FOR OTHER ENTITIES. THE NAVAJO NATION IRB IS OFFICIALLY CALLED NAVAJO NATION HUMAN RESEARCH REVIEW BOARD. AND THIS WAS CODIFIED BY THE NAVAJO NATION COUNCIL SO THAT'S HOW WE REFER TO OURSELVES. AND A LOT OF THE LITERATURE GOING OUT, IT'S HOW IT'S WRITTEN. AND AS FAR AS THE BOARD IS CONCERNED, WE'RE STRICTLY FROM THE NAVAJO NATION A RESEARCH CODE, OUR DOCUMENT. WHATEVER IS WRITTEN THERE IS WHAT WE GO BY. SO WE HAVE TO CARRY OUT, YOU KNOW, THE LAW AND THE ADMINISTRATION OF THESE RESEARCH APPLICATIONS. SO IN THE CODE, I DON'T WANT TO PROVIDE MY OWN PERSPECTIVE OR MY OWN OPINION OR PARAPHRASE, THE CODE STATES THAT ALL DATA AND RESEARCH SUBJECT TO THIS CODE, IT SAYS, ARE THE PROPERTY OF THE NAVAJO NATION. THAT'S WHAT IT SAYS. ALTHOUGH RESEARCHERS MAY BE GIVEN A PERMIT. SO WE FOLLOW THIS. AND SO WE TELL PEOPLE THE RESEARCHERS ABOUT THIS PROPRIETIORSHIP. WHEN WE SEARCHERS MAKE THE APPLICATION WE TELL THEM AT THE END, ALL THE RESEARCH INFORMATION DATA HAS TO BE GIVEN BACK TO THE TRIBE. IF THE RESEARCH IS CONDUCTED ON THE RESERVATION. AND SO OUR CHAIR, MADAM CHAIR HERE, I KNOW SHE ALMOST -- ALMOST EVERY MEETING SHE VERBALIZES THIS TO THE RESEARCHERS. ALSO, WITHIN THE NAVAJO DEPARTMENT OF HEALTH THEY HAVE A NAVAJO NATION EPIDEMIOLOGY CENTER. AND DAVID FOLEY IS HERE FROM THE OFFICE, SO GLAD THAT HE'S HERE. AND SO MOST OF THIS DATA WE SAY GOES BACK TO THE TRIBE. NOT THE IRB. IT DOESN'T COME TO US. EVENTUALLY IT'S GIVEN TO THE TRIBE, AND THE TRIBE THROUGH THE EPICENTER, THE ADMINISTRATIVE DATA AND THEY HAVE THEIR OWN SERVER AND THEY IN TURN, I KNOW THEY SHARE DATA WITH THE STATE OF ARIZONA IHS AND SO THEY HAVE A LOT OF THE INTERNAL WORKING. ACCORDING TO WHAT I READ ON THE NAVAJO EPICENTER, THROUGH THE TRIBAL EPICENTER, THE NAVAJO EPICENTER PRIMARY OBJECTIVES ARE DATA COLLECTION, IT SAYS, ANALYSIS AND INTERPRETATION. DATA SHARING. IN ADDITION, INTEGRATE SPIRITUAL AND CULTURAL VALUES INTO EPIDEMIOLOGICAL METHODS. SO IF NIH WANTS RESEARCH DATA, THE NAVAJO NATION, THEY WOULD HAVE TO CONTACT THE NAVAJO NATION DEPARTMENT OF HEALTH, NOT IRB. AND I ASSUME SOME CONTRACT OR AGREEMENT MAY HAVE TO BE DRAFTED, AND I GUESS MUCH WILL DEPEND ON WHAT KIND OF DATA, HOW IT'S GOING TO BE USED, AND I ASSUME IT'S GOING TO BE ONE OF THOSE CASE BY CASE. WITH THE IRB, WE'RE ASSIGNED AN IRB COORDINATOR, NAVAJO DEPARTMENT OF HEALTH. ACCORDING TO THE LAW, AGAIN, IT SAYS THAT COORDINATOR SHALL DEVELOP AND MAINTAIN AN UP-TO-DATE FILE ON ALL RESEARCH PROJECTS, PAST, AND ONGOING, APPROVED AND DISAPPROVED FOR AT LEAST TEN YEARS. AND (INDISCERNIBLE) IS OUR IRB COORDINATOR. EVENTUALLY THEY HAVE TO WORK WITH THE NAVAJO EPICENTER TO TRANSFER A LOT OF THIS DATA. AND SO WE'RE LIKE SITTING IN BETWEEN, AS IRB, WE DON'T OWN THE DATA. YOU KNOW, WE HAVE OVERSIGHT ON THE RESEARCH DATA, AS RESEARCH IS GOING ON. AND THEN YOU TELL PEOPLE AT THE END TO TRANSFER ALL THE DATA, AT THE END. AS FAR AS CONFIDENTIALITY, AND SECURITY IS CONCERNED, THE NAVAJO NATION LAW, THE CODE SAYS THAT THERE MUST BE ADEQUATE ASSURANCE AS DETERMINED BY THE NAVAJO NATION HUMAN RESEARCH REVIEW BOARD THAT THE DATA HAND INFORMATION GENERATED DURING THE CONDUCT OF RESEARCH IS PROTECTED FROM UNAUTHORIZED ACCESS AND MISUSE CONSISTENT WITH INFORMED CONSENT PROVISION, THE NAVAJO NATION PRIVACY ACT AND OTHER NAVAJO NATION INFORMATION TECHNOLOGY REQUIREMENTS. AND SO WE HAVE THIS THAT'S WRITTEN. ALSO, SOME OF THIS INFORMATION IS ALSO WRITTEN INTO THE NAVAJO -- THE FUNDAMENTAL LAW, THE TRADITIONAL LAW. AND ONE OF THEM HERE, I QUOTE IT, IT IS THE RIGHT AND FREEDOM OF THE PEOPLE THAT EVERY CHILD AND EVERY ELDER BE RESPECTED, HONORED AND PROTECTED WITH THE HEALTHY PHYSICAL AND MENTAL ENVIRONMENT FREE FROM ALL ABUSE. AND SO, YOU KNOW, WE HAVE THESE DIFFERENT LAWS WRITTEN IN SO MANY DIFFERENT WAYS THAT THE BOARD FOLLOWS. WE ONLY FOLLOW WHAT'S WRITTEN IN THE LAW. WE DON'T MAKE OUR OWN LAW. AND SO WE JUST CARRY OUT WHAT'S WRITTEN IN THE TRIBAL CODE, AND WHAT WE'RE EXPECTED TO DO, AND THE OPERATION OF THE IRB'S WRITTEN OUT AND SO WE JUST FOLLOW THAT IN THE EXECUTION OF OUR DUTIES. I WANT TO MAKE A LITTLE COMMENT ON THE NAVAJO NATION PRIVACY ACT. A LOT OF PEOPLE GO BACK TO THAT, IT'S BEEN MENTIONED HERE AND THERE. AS I READ THE ACT, THE ACT MAINLY IS ABOUT INTERNAL DATA SHARING, WITHIN THE NATION. AND THERE'S NO REFERENCE TO OUTSIDE ENTITIES LIKE THE FEDERAL AGENCY, OR OTHER RESEARCH INSTITUTIONS. THERE'S ACKNOWLEDGMENT IN THE PRIVACY ACT THAT SAYS DATA SHARING BELONGS TO INDIVIDUALS. IT SAYS DATA BELONGS TO THE INDIVIDUAL. IT SEEMS TO ALSO READ THAT THE INDIVIDUAL CAN SHARE THEIR DATA WITH THE NATION. YOU KNOW, THROUGH CONSENT FORM, INDIVIDUAL CONSENT, AND THE NATION CAN IN TURN SHARE WITH OUTSIDE ENTITIES. IT SEEMS TO BE, YOU KNOW, WHAT I READ IN THE NAVAJO NATION PRIVACY ACT. AND THE NAVAJO NATION COLLECTS THE DATA IN TRUST FOR THE INDIVIDUAL NAVAJO. SO -- AND IF THE NAVAJO NATION OWNS THE DATA, ACCORDING TO TRIBAL LAW, THE NATION WILL HAVE TO ENTER INTO CONTRACT OR AGREEMENT WITH OTHER ENTITIES INCLUDING FEDERAL AGENCIES. AND LIKE I SAID EARLIER, YOU KNOW, PROBABLY CASE BY CASE BECAUSE EACH AGREEMENT MAY BE DIFFERENT AND DISTINCT AND MIGHT STAND ON THEIR OWN, AND, YOU KNOW, ARE THESE AGREEMENTS GOING TO BE IN PERPETUITY? THOSE ARE SOME OF THE QUESTIONS. THE NAVAJO NATION 15 YEARS AGO PUT A MORATORIUM ON GENETIC RESEARCH. IT'S BEEN PUT ON HOLD FOR 15 YEARS NOW. LATELY, THERE'S A MOVEMENT BY THE TRIBAL ADMINISTRATION TO LIFT THAT MORATORIUM AND TO DEVELOP A POLICY THAT WOULD REGULATE AND MONITOR ALL RESEARCH ON THE RESERVATION AS IT RELATES TO GENETIC AND MANY OF YOU KNOW, YOU KNOW, THAT A LOT OF THIS GENETIC ANALYSIS AND ASSESSMENT IS ALREADY DONE BY THE IHS. YEAH, I THINK DR. LYLE MENTIONED THAT. SO WHERE -- SO IT'S ALREADY GOING ON. WE HAVE 332,000 MEMBERS, YOU KNOW, OF THE NAVAJO NATION. OVER A QUARTER OF A MILLION PEOPLE, CLOSE TO A MILLION PEOPLE WITH INCREASE IN POPULATION. THAT'S A LOT OF PEOPLE. AND MANY OF OUR PEOPLE ARE OFF THE RESERVATION. THEY ARE NOT COVERED BY THIS, THAT I'M TALKING ABOUT. WHO TALKS FOR THEM, WE DON'T KNOW. AND MANY OF THEM HAVE MOVED OFF THE RESERVATION INTO THESE BIG CITIES, THEY TAKE UP EMPLOYMENT, SOME PROFESSIONALS JOBS. THEY GO TO SCHOOL. AND SOME ARE THERE PERMANENTLY. AND THEY HAVE -- THEY COME BACK TO THE RESERVATION TO VISIT AND ENGAGE IN CEREMONIAL CULTURAL ACTIVITIES AND THAT'S THE EXTENT OF IT. SO MANY OF OUR PEOPLE ARE OFF THE RESERVATION THESE DAYS. AND SO MAINLY WHAT WE'RE TALKING HERE IS WITHIN THE INTERIOR BOUNDARY OF THE NAVAJO RESERVATION. AND THE MORATORIUM DISCUSSION HAS GONE BACK OUT TO THE PUBLIC, THE NAVAJO NATION PRESIDENT PUT OUT FOR THE COMMUNITY HERE, ONE HAPPENED THIS LAST THURSDAY AND ANOTHER ONE IS GOING TO BE THIS WEEK, ANOTHER ONE NEXT WEEK, AND THEN ANOTHER ONE AFTER THAT. THEY ARE GETTING PUBLIC INPUT. AND SO I WENT TO ONE OF THE HEARINGS, AND ONE OF THE ELDERS, MUST BE IN HIS 90s, AND IN THE TRIBAL LAND WHICH, YOU KNOW, THIS IS WHAT HE SAID. HE SAID -- I'M NOT GOING TO SAY THIS IN THE TRIBAL LANGUAGE BUT, YOU KNOW, I WROTE DOWN WHAT I THOUGHT HE SAID. HE SAID YOU KNOW WE SENT OUR DATA OUT THERE, HE SAYS, SEND OUR DATA OUT THERE. INCLUDING OUR BLOOD AND OTHER BIOLOGICAL SPECIMENS. AND TO THE UNIVERSITIES. AND OTHER FEDERAL FUNDED AGENCIES, WITHOUT ASSURANCE THAT THEY WILL BE SAFEGUARDED, RETURNED OR DESTROYED. AND WE PUT TOO MUCH TRUST INTO A SYSTEM THAT IS NOT CLEARLY DEVELOPED. AND FOR THE NATIVE AMERICAN, WE HAVE A PROBLEM WITH TRUST BECAUSE WE HAVE BEEN VIOLATED SO MUCH AND IN THE PAST OUR DATA HAVE BEEN MISUSED. AND THE WAY I SEE IT, HE SAYS, IT APPEARS DATA SHARING EVOLVED ON ITS OWN OVER THE YEARS, JUST LIKE A BIG FEDERAL BUDGET DEFICIT. YOU KNOW, IT'S EVOLVED. NOBODY REALLY THOUGHT ABOUT IT, THOUGHT IT OUT, YOU KNOW, IT JUST DEVELOPED AND NOW WE HAVE, YOU KNOW, WE'RE TALKING ABOUT IT AS IF IT HAS BEEN VERY WELL THOUGHT OUT AND WE HAVE DATA SHARING SYSTEM THAT'S COMPREHENSIVE. SO HE WAS QUESTIONING THAT. AND SO HE WENT ON AND HE SAYS, MY QUESTIONS ARE ONCE DATA IS SHARED OUTSIDE THE NATION, WHO CONTROLS IT? HOW WILL DATA BE PROTECTED ONCE SHARED? FOR HOW LONG? HOW WILL THAT BE DETERMINED? HOW WILL VIOLATORS BE HANDLED IF THERE ARE BREACHES? AND LAST QUESTION THAT HE PUT WAS DOES THE NATION HAVE THE PHYSICAL OR HUMAN CAPABILITY TO HANDLE LARGE VOLUME OF DATA ONCE A COMPREHENSIVE SYSTEM IS SET UP? HE SAYS, I REALLY DON'T THINK WE HAVE THAT CAPABILITY YET. AND HE ASKED, YOU KNOW, MAYBE THERE'S A TRIBE OUT THERE THAT HAS THE CAPABILITY. YOU KNOW, MAYBE SOMEWHERE THERE'S A BLUEPRINT. I TOLD HIM I WAS COMING HERE. HE SAID, ASK THEM ABOUT BLUEPRINT, MAYBE THERE'S A BLUEPRINT OUT THERE, YOU KNOW, WE NEED TO, YOU KNOW, BORROW AND SO WE CAN GET ORGANIZED AND SET OURSELF ON THE RIGHT TRACK. SO I THINK WHEN YOU TALK ABOUT SOME OF THESE ISSUES, LIKE GENETIC RESEARCH, YOU KNOW, YOU TALK ABOUT SOME VERY, VERY HARD TO UNDERSTAND TECHNICAL TERMS TO THE LAYPEOPLE. YOU KNOW, WHEN YOU TALK ABOUT DNA, WHEN YOU TALK ABOUT THE HUMAN CELL, THE INTERIOR OF THE CELL, AND THEN THE DNA, THE DNA DAMAGE, THE GENES AND THEN WHEN YOU TALK ABOUT THE HUMAN DISEASE THAT MAY COME FROM THE ENVIRONMENT, YOU KNOW, THE LIFESTYLE, YOU KNOW, IT'S HARD TO TALK ABOUT THESE THINGS IN THE TRIBAL LANGUAGE. AND ALMOST ANY OF THESE SUBJECT AREAS, YOU KNOW, I INTERACT WITH THE COMMUNITY A LOT WHEN I GO INTO THE GRASS ROOT COMMUNITY. THEY ASK A LOT OF GOOD QUESTIONS, AND THEY ARE AWARE OF IT. AND, FOR EXAMPLE, SOME OF THE THINGS I WAS TALKING ABOUT, THE GENES, ONE OLD MAN SAYS, WELL, YOU KNOW, WHAT ARE YOU TALKING ABOUT? YOU KNOW, WE TALK ABOUT GENES, NOT THROUGH THE WORD "GENE." YOU KNOW, WE INTRODUCE OUR SELF BY CLAN, YOU KNOW. MY SISTER BACK THERE, YOU KNOW. IT'S ALL ABOUT GENES. WE USE THE CLAN SYSTEM. YOUR CLAN, YOUR FATHER'S CLAN, YOUR FATHER'S FATHER'S CLAN, YOUR MOTHER'S FATHER'S CLAN. YOU KNOW, YOU DON'T MARRY INTO THOSE GENES. YOU KEEP THE BLOOD PURE. IT'S BEEN DONE THROUGH THE GENERATION. ANOTHER ONE IS, YOU KNOW, WE RAISE LIVESTOCK OVER THE YEARS, YOU KNOW, SHEEP. EVERY TWO YEARS WE BRING IN A BRAND NEW RAM. EVERYBODY MAKES THEIR SELECTION. THAT ONE REALLY HAS IT. THAT RAM GETS SELECTED. OLD ONE GOES TO THE PASTURE, YOU KNOW. AND SO THEY DO THAT WITH THEIR GOATS. WE'VE BEEN DOING THIS FOR YEARS AND YEARS. AND, YOU KNOW, CULTURALLY IT WAS A WAY OF LIFE. WE DO THAT WITH OUR HORSES TOO. AND YOU JUST DON'T -- IF YOU HAVE A STUD, MAKE SURE THAT STUD IS LOCKED UP AND YOU DON'T -- YOU DON'T RUIN THE BLOOD OF THAT STUD. AND SO PEOPLE HAVE DONE THIS. MY UNCLE USED TO RAISE HORSES. HE USED TO BE VERY ADAMANT, YOU KNOW, TO MAKE SURE THE STUD DOESN'T GO OUT, YOU KNOW, AND ROAM WITH OTHER MARES. WHEN PEOPLE BROUGHT THEIR MARES, YOU KNOW, HE WANTS PAPERWORK ON IT BEFORE HE WILL ALLOW BREEDING TO HAPPEN. HE PAID A LOT OF MONEY FOR THESE STUDS AND SO HE WANTED THOSE AND SO PEOPLE DID THIS, SO IT'S NOT REALLY NEW KNOWLEDGE. IT WAS TALKED ABOUT CULTURALLY SO YOU USE THESE KIND OF INFORMATION TO GET TO THE CORE OF A LOT OF THE ISSUES WHEN YOU GO DO A LOT OF CROSS-CULTURAL COMMUNICATION, AND SO I DO THAT FREQUENTLY. JUST THE OTHER DAY WE WERE TALKING ABOUT AUTOIMMUNE SYSTEM, YOU KNOW, AND ONE OF MY COLLEAGUES SAYS IT. CAN YOU EXPLAIN TO THESE FOLKS HERE ANTI-NUCLEAR ANTIBODIES, YOU KNOW? IT'S EASY FOR HER TO SAY, YOU KNOW. SO IT CAN BE DONE, YOU KNOW. WE DO HAVE WORDS, YOU KNOW. AT THE END, THEY GO, I GOT IT. YEAH, IT'S PRETTY CLEAR. SO, YOU KNOW, IT'S A COMMUNICATION SYSTEM THAT'S FOR US, I IMAGINE FOR SOME TRIBES THE SAME, THE CONSCIOUSNESS OF THE PEOPLE IS DIFFERENT. IF YOU'RE TRAINED HERE USING THE ENGLISH METHODOLOGY WHICH IS ROOTED IN CARTESIAN, IF YOU'RE TRAINED THROUGH THE CARTESIAN METHODOLOGY, THROUGH EQUATIONS AND LEARNING ABOUT THE CARTESIAN COORDINATES, ALGEBRA AND SO ON AND SO FORTH, THEN YOUR MIND IS GOING TO WORK A CERTAIN WAY. THAT'S NOT THE WAY OF THE NATIVE MIND. YOU KNOW, IF YOU GO BACK IN TIME. EVEN PEOPLE THAT ARE NOT EXPOSED TO THIS WAY OF THINKING, YOU KNOW, IT'S IN HERE, IN THE GENE, YOU KNOW, INTUITIVELY THEY FEEL IT. YOU KNOW, THEY FEEL THAT. SO WHEN PEOPLE, NATIVE PEOPLE TALK ABOUT THE NATIVE MIND, IT'S DIFFERENT. YOU KNOW, IT'S A HOLISTIC MIND, YOU KNOW, WHERE YOU DON'T TAKE THE PIECE, TALK ABOUT THE PIECES. IT'S ALL -- IT WORKS AS ONE BODY. YOU KNOW, YOU CAN TALK ABOUT THE HEART, YOU CAN TALK ABOUT THE LIVER HERE, YOU KNOW, SEPARATELY. BUT IT ALL WORKS TOGETHER. THEY ALL, YOU KNOW, ONE CAUSE AFFECTS NOT JUST ANOTHER BUT CAUSES EVERYTHING. YOU KNOW, LIKE AN EVOLUTION OF THE WHOLE SYSTEM. SO IF YOU TAKE THE CAUSE AND EFFECT METHODOLOGY AND PUT IT INTO NATIVE WAY OF THINKING, IN THE CAUSE AND EFFECT BREAKS DOWN. YOU KNOW, YOU HAVE TO -- IT'S EVOLUTION OF A WHOLE SYSTEM. THAT'S HOW ORGANICALLY NATURE WORKS. IT WORKS HAS A WHOLE. YOU KNOW, WHEN YOU GO TO THE MIND OF THESE KIND OF PEOPLE, AND YOU COME IN HERE WITH THESE MEDICAL TERMINOLOGY, IT'S HARD TO TRY TO GET INTO THAT MIND WHEN THEIR MIND IS DIFFERENT. AND I GUESS THE SAME FROM THERE GOING BACK THIS WAY. SO YOU KNOW WE HAVE A WIDE, YOU KNOW, COMMUNICATION GAP THAT GOES ON ALL THE TIME. THOSE ARE SOME OF THE CHALLENGES AND ALL THIS RESEARCH THAT'S BEING CONDUCTED, MADAM CHAIR IS ADAMANT. YOU GO BACK TO THE COMMUNITY. HERE YOU'RE GIVING US, YOU KNOW, ASKING US FOR APPROVAL FOR YOU TO GO TO EDINBURGH, SCOTLAND, YOU KNOW, BUT YOU ALSO GO BACK TO THE COMMUNITY WHERE YOU CONDUCT THIS RESEARCH. YOU'RE RESPONSIBLE TO THESE PEOPLE. YOU GET INTERPRETERS TO MAKE SURE THAT THIS IS WELL COMMUNICATED. AND SO THAT PEOPLE CAN USE THIS INFORMATION. AND SO AS FAR AS THE GRASS ROOT PEOPLE ARE CONCERNED WE GET CRITICIZED. OH, THIS RESEARCH IS GOING ON. WE NEVER GET IT BACK. YOU KNOW, WE'VE JUST BEEN USED OVER AND OVER. WE GET IT ALL THE TIME, FROM OUR OWN PEOPLE. AND SO WE HAVE TO REALLY PUSH TO GET THIS INFORMATION BACK TO THE COMMUNITY. >> YOU KNOW, I'D LIKE TO JUST SAY THAT I THINK IT WOULD BE REALLY GREAT IF NIH WOULD PROVIDE AND HELP TRIBES WITH THE DEVELOPMENT OF A FACILITY SO THAT THE TRIBES CAN MANAGE AND ENSURE SECURITY OF DATA THAT THE NATION HAS, AND SO THE TRIBES COULD HOUSE THAT DATA. AND AS I SAID, WHEN YOU TALK ABOUT DATA, YOU TALK ABOUT A SPECIFIC THING, BUT IN NAVAJO WAY IT GOES BEYOND THAT SPECIFIC THING. FOR EXAMPLE WHEN YOU'RE TALKING ABOUT NORTHEAST, SOUTHWEST, THOSE ARE POINTS OF DIRECTION BUT TO NAVAJO IT'S A MEANS BY WHICH FAMILIES ARE TO WORK TOGETHER TO DEVELOP AND ENSURE THAT THEIR FAMILY IS TAKEN CARE OF, AND SO IT GOES BEYOND JUST DIRECTION. IT GOES BEYOND INTO TRADITIONAL CONCEPTS AND CULTURE AND I THINK THAT'S A LOT OF THE THINGS THAT WE THINK ABOUT WHEN WE TALK ABOUT RESEARCH. ESPECIALLY TO THE ELDERLY. I ALWAYS THINK THE ELDERLY AND THE MEDICINE MEN THEY ARE TRIBAL ENCYCLOPEDIAS. THEY HAVE ALL THE KNOWLEDGE AND THE ABILITIES AND CERTAINLY WHEN THE ISSUE OF GENETIC RESEARCH CAME FORTH THEN THE FORMER VICE PRESIDENT, DR. TAYLOR MCKENZIE, WAS A CO-CHAIR ON THE IRB WITH ME, AND WE TOLD THE OVERSIGHT COMMITTEE FOR THE TRIBAL COUNCIL THAT WE WERE HAVING A LOT OF PROTOCOLS WANTING TO DO, SAY, ON GENETICS, AND WE ASKED THE COMMITTEE WHAT WOULD YOU LIKE US TO DO, WHAT NEEDS TO HAPPEN. SO THEY DIRECTED MY AND DR. TAYLOR MCKENZIE TO DEVELOP A VIDEO IN NAVAJO, UTILIZING THE MEDICINE MAN'S ASSOCIATION, THE NATIVE AMERICAN CHURCH, AND COMMUNITY MEMBERS AND OTHER INDIVIDUALS THAT WANT TO SPEAK OF THEIR THOUGHTS OF GENETIC STUDIES AND SO WE DID THAT VIDEO, AND THAT VIDEO WAS ON 8-TRACK BUT IT'S GOING TO BE DEVELOPED INTO A DISC SO THAT ANYONE WANTING TO LOOK AT IT WOULD BE ABLE TO LOOK AT IT. AND SO THEN IN ADDITION WE WERE TO GO TO THE MEDICINE MAN'S ASSOCIATION AND THE NATIVE AMERICAN CHURCH TO GET THEIR THOUGHTS, IF THEY SUPPORTED IT, THIS IS WHAT THEY WANTED TO TAKE PLACE REGARDING GENETICS. THE MEDICINE MAN'S ASSOCIATION, THERE ARE 105 MEDICINE MEN THAT CAME TODAY IN EDUCATION BUILDING IN WIND DROP, AND MYSELF AND DR. TAYLOR MCKENZIE PRESENTED THE REASON WE WERE THERE BECAUSE WE WANTED INPUT REGARDING GENETIC STUDIES, WHETHER THE NATION SHOULD APPROVE THAT OR DISAPPROVE THAT. SO THERE WAS A MEDICINE WOMAN THAT WAS SITTING THERE AND SHE SAYS, I'M GOING TO MAKE A MOTION TO GO AHEAD AND LET IT HAPPEN BECAUSE OUR KIDS ARE IN SCHOOL AND IN COLLEGE TO LEARN ABOUT THESE THINGS SO THAT THEY WILL BE ABLE TO COME HOME AND HELP THEIR PEOPLE. AND THEN THERE WAS ANOTHER MEDICINE MAN THAT STOOD UP ON THE SIDE OF THE WALL AND HE SAID, I DO NOT THINK THAT WE NEED TO DO ANY STUDIES ON GENETIC RESEARCH BECAUSE THERE'S A LOT ABOUT IT THAT WE NEED TO BE VERY CAREFUL ABOUT AND WE'RE NOT READY FOR IT. HE SAID, MY DAUGHTER AND DR. TAYLOR MCKENZIE, WE'RE GOING TO TELL YOU A STORY. AND WE STARTED THE MEETING AT 9:00 AND DIDN'T END UNTIL 4:00. WHAT THE NAVAJO NATION NEEDS TO DO, HE SAID, I SECOND THAT MOTION TO NOT APPROVE ANY GENETIC STUDIES. THEN WE WENT THROUGH NEW MEXICO AND MET WITH THE NATIVE AMERICAN CHURCH, AND WE TOLD THEM WHAT WE WERE THERE FOR AND THEY SAID THAT THEY DISCUSSED A LOT ABOUT IT, AND THEN THEY SAID, I THINK IT WOULD BE OKAY, PROVIDED YOU HAVE THE RULES, LAWS AND REGULATIONS TO SAFEGUARD THIS INFORMATION SO NOT EVERYBODY CAN HAVE THAT INFORMATION TO THEMSELVES. SO THOSE WERE THE TWO RESOLUTIONS, AND THEN WE SENT THE VIDEO, IT'S CALLED "THE GIFT OF LIFE" TO EACH ONE OF THE CHAPTERS ALONG WITH THE RESOLUTION TO APPROVE IT AND A RESOLUTION TO DISAPPROVE IT. TO SEE WHAT THE CHAPTERS WOULD WANT TO DO IN THEIR COMMUNITIES. AND WE ACTUALLY ONLY HAD TWO CHAPTERS THAT EVEN TOOK ACTION ON THIS STUDY. A LOT OF THE INFORMATION THAT WE GATHERED WAS THAT THEY DIDN'T REALLY UNDERSTAND EXACTLY HOW GENETICS WOULD ENHANCE THE LIVES OF NAVAJO PEOPLE THEY DIDN'T UNDERSTAND THAT THERE'S A POSSIBILITY TO TAKE CARE OF ILLNESSES OR DIFFERENT ISSUES AS FAR AS DISEASES ARE CONCERNED. SO THERE WAS A LOT OF MIXED EMOTION AS WE WENT THROUGH THESE CHAPTERS AND GOT THEIR INFORMATION TO THEM. THEN WE DID A RADIO TALK SHOW ON GENETIC STUDIES AND CALLERS WOULD CALL IN AND ASK US QUESTIONS AND SO THERE WAS MYSELF, A DOCTOR AND TWO OTHER IRB MEMBERS THAT ANSWERED THE QUESTIONS THAT THE COMMUNITY WANTED ANSWERS TO. WE HAD ONE INDIVIDUAL THAT SAYS, I DON'T THINK IT'S TIME FOR US TO BE DOING THIS. THERE WILL COME A TIME AND PLACE WHEN THIS ISSUE WILL COME BACK, BUT WE RIGHT NOW DON'T NEED THIS AT ALL. AND SO A LOT OF COMMENTS RECEIVED WERE BASICALLY OPPOSING IT BUT NOW THAT WE'RE GOING BACK TO TALKING ABOUT LIFTING THE MORATORIUM THEN WE'LL HAVE TO SEE WHAT HAPPENS. THERE ARE THREE NAVAJO LADIES THAT GOT THEIR PROTOCOL APPROVED REGARDING GENETIC STUDIES. THEY WANTED TO COME ON TO NAVAJO, THEY WERE NAVAJO WOMEN FROM ALASKA, THEY WANTED TO INTERVIEW PEOPLE AND GOT THOUGHTS REGARDING GENETICS. AND SO THEY WILL BE WORKING ON THAT PROCESS. AS TO THE OUTCOMES OF THEIR STUDY WE'RE NOT SURE HOW LONG THAT WILL TAKE OR WHAT WILL HAPPEN. SO WE JUST WANT TO MAKE SURE THAT THE INFORMATION GATHERED THE DATA, IT'S ABOUT YOU AND ME, IT'S ABOUT OUR CHILDREN, OUR GRANDCHILDREN AND GREAT GRANDCHILDREN. AND WE NEED TO BE ABLE TO TAKE CARE OF THIS ISSUE FROM A TRIBAL PERSPECTIVE, NOT A NON-INDIAN PERSPECTIVE. NIH AS A FEDERAL ENTITY NEEDS TO HELP TRIBES WITH THE DEVELOPMENT OF A FACILITY ON THEIR RESERVATION TO STORE AND SECURE ANY DATA THAT IS -- THAT WOULD BE TAKEN FROM THE COMMUNITIES. AND IT WILL CREATE JOBS AND IT WILL BE MAINTAINED AND CONTROLLED BY TRIBES. AND SO THERE NEEDS TO BE A REAL COMPREHENSIVE PLAN TO SHARE DATA, TO MAKE SURE IS THIS WHAT WE WANT TO BE TAKING OUT FROM WHEREVER, FROM ANY FEDERAL AGENCY. SO WITH THAT, I THINK THAT I'D LIKE TO TAKE THE OPPORTUNITY AT THIS TIME TO HAVE OUR HONORABLE COUNCIL DELEGATE WALTER PHELPS SPEAK ON THIS ISSUE BECAUSE HE'S REALLY GENERALLY INVOLVED IN IT. HE'S COMMITTED.& HE'S DEDICATED AND HE'S A VERY AWESOME PERSON. I JUST ADMIRE THIS YOUNG MAN. AND SO AT THIS TIME, WALTER PHELPS. >> ONE MOMENT, WALTER. I WANT TO REMIND EVERYBODY, I SAID I WOULD DO THIS OF THE TIME. WE HAVE TEN MINUTES LEFT BEFORE OUR NEXT PRESENTATION. SO I'M FINE WITH YOU SPENDING TIME HOWEVER YOU LIKE BUT IF THERE'S QUESTION AND ANSWER COMMENTARY WE MIGHT WANT HAVE TO THAT BUT IF WE DON'T HAVE TIME THAT'S OKAY. I'M JUST THROWING IT OUT. >> I JUST WANT TO KNOW IF YOU'RE DONE WHISPERING OVER THERE. [LAUGHTER] WE HAD THIS CONVERSATION, SEVERAL OF OUR MEETINGS, DISCUSSING DATA COLLECTION, DATA OWNERSHIP, DATA SOVEREIGNTY, AND I THINK THAT, YOU KNOW, IN ORDER FOR US AS NATIONS TO REALLY WORK EFFECTIVELY WITH NIH AND FEDERAL AGENCIES IN THIS ARENA, I THINK WHAT WHAT I FEEL IS WE NEED EACH OTHER, AND I REALLY APPRECIATE THE TIME THAT I SPENT GOING TO VISIT ALASKA, THE HEALTH CANCER CENTER THEY HAVE IN ANCHORAGE. YOU KNOW, IT'S AWESOME TO SEE THAT. IT WOULD BE GOOD TO ALSO VISIT OTHER FACILITIES, FOR US AT NAVAJO WE'RE THE ONLY TRIBE I BELIEVE -- I BELIEVE WE'RE THE ONLY TRIBE THAT HAS A MORATORIUM. I DON'T THINK OTHER TRIBES DO. SO WE -- BECAUSE NATIONS -- THE COUNCIL INSTALLED A MORATORIUM BACK IN 2002, AND RESEARCH BEING, YOU KNOW, SIGNIFICANT AREA OF WORK THAT NEEDS TO BE DONE, AND THE CHALLENGES THAT OUR PEOPLE FACE WITH REGARDS TO, YOU KNOW, THE TYPES OF DISEASES AND TYPES OF HEALTH CHALLENGES, WITH DIABETES, WITH CANCER, WITH CARDIOLOGY, WHATEVER THOSE NEEDS ARE, IT GOES BACK TO BEING ABLE TO COLLECT DATA, TO DEAL WITH SPECIMENS, DEALING WITH, YOU KNOW, BEING ABLE TO FIND TREATMENTS THAT WOULD BE, YOU KNOW, HELPFUL FOR OUR PEOPLE, FOR OUR COMMUNITY MEMBERS. BECAUSE I THINK ONE OF THE PASSIONS THAT ALL OF US, THOSE OF US IN THE MEDICAL FIELD, THOSE OF YOU THAT ARE INVOLVED MUCH MORE DEEPLY INVOLVED AND COMMITTED IN YOUR DISCIPLINES IS BECAUSE, YOU KNOW, WE ALL UNDERSTAND THE MORTALITY RATES, THE MORTALITY RATES IN ALL OF THESE HEALTH AREAS. AND I THINK THAT FOR NAVAJO WE SEE THAT PERHAPS EVEN LARGER, BECAUSE OUR POPULATION IS LARGER, AND SO -- AND THEN THE AMOUNT OF MONEY THAT THE NATION SPENDS IN CONTRACT HEALTH CARE COSTS GOING TO SPECIALTY CARE BECAUSE WE DON'T HAVE THE EXPERTISE WITHIN OUR OWN COMMUNITIES AND HOSPITALS, THESE ARE SOME OF THE REASONS THAT ARE DRIVING US FORWARD SO THAT WE REALLY NEED TO TAKE A SECOND LOOK AT THE POLICY AND THE MORATORIUM AND TAKE A SECOND LOOK TO SEE HOW WE CAN MOVE FORWARD. AND SO I REALLY APPRECIATE AND I'M SO PRIVILEGED TO HAVE MY ELDERS HERE, YOU KNOW. I THINK WHAT THEY PRESENTED TO US, TO ME, IS, YOU KNOW, THESE ARE THE KINDS OF PEOPLE WE HAVE AND THEY REPRESENT JUST, YOU KNOW, SOMETHING THAT MAKES ME FEEL VERY HUMBLE, YOU KNOW, THAT THEY ARE HERE. I'M VERY GLAD THAT WE -- THAT THE COMMITTEE HERE WANTED TO INVITE NAVAJO IRB, BECAUSE WE NEED INPUT AND LEADERSHIP FROM THIS BODY AS WELL, AND WE NEED GUIDANCE AS TO WHICH WAY WE'RE GOING TO MOVE FORWARD TOGETHER, BUT WITH NAVAJO I MEAN INTERNALLY WE ARE ADDRESSING THESE ISSUES AND WE WANT TO SEE SOLUTIONS AND MOVE FORWARD. BUT AT THE SAME TIME AS DR. BEGAY SAID, WE HIGHLY VALUE COMMUNITY INPUT, YOU KNOW, AND WE WANT TO MAKE SURE THAT THAT IS AN ESSENTIAL COMPONENT OF EVERY MOVE WE MAKE, EVERY POLICY THAT'S WRITTEN IS THAT THERE IS TRANSPARENCY THROUGH THIS WHOLE PROCESS, SO THANK YOU. I'M SO HAPPY THAT THEY ARE HERE WITH ME TODAY. [APPLAUSE] >> THANK YOU VERY MUCH. >> ALL RIGHT. I TOO WANT TO THANK YOU ALL FOR YOUR INFORMATION AND FOR SHARING YOUR STORY WITH US. A FEW MINUTES FOR SOME COMMENTS. I SEE MALIA. >> I'LL CHIP IN QUICKLY. IT'S AN HONOR, JUST HEARD SO MUCH OVER THE YEARS. TO HAVE YOU SITTING HERE IS A CRITICAL MOMENT. THANK YOU FOR BEING HERE. I WANT TO THROW OUT QUICKLY AS WE'RE TRYING TO LEARN FROM YOUR EXPERIENCE, WHICH I THINK IS CRITICAL, THERE'S AT LEAST TWO THINGS THAT I HEARD THAT FOR US AS A COMMITTEE I WANT TO PUT OUT THERE. AND GENERATE MORE INSIGHT. ONE IS WHEN I WAS AT NCI AND SINCE, WE HEARD A LOT ABOUT TENSIONS BETWEEN RESEARCHERS AND COMMUNITIES AND I THINK THIS BODY HAS A RESPONSIBILITY TO TRY TO ADDRESS THAT. ONE OF THE THINGS WHERE A LOT OF TENSIONS EMERGE IS AROUND TIME LINE AND THE TIME THAT IT TAKES TO DO THE RIGHT THING WHEN IT COMES TO COMMUNITY ENGAGEMENT. I LOVED THE PHASES AND HOW YOU LAY THAT OUT VERY EXPLICITLY AND ONE OF THE THINGS I'D LOVE TO HEAR OVER TIME, I DON'T KNOW THAT WE HAVE IT TODAY, BUT ABOUT WHAT HAVE YOU FOLKS LEARNED AND INSIGHTS ABOUT HOW TO TALK TO RESEARCHERS AND INSTITUTIONS LIKE NIH ABOUT RESPONSE IT RESPONSIBILITY WAS TIME LINE AND BUDDING RESEARCHERS, I'VE ADVISE A FEW NOT TO FOCUS ON PRIMARY RESEARCH SO THAT'S ONE ARENA. AND THE OTHER THAT YOU MENTION IS TERRITORIAL JURISDICTION. THERE'S A HUGE PIECE. ONE OF THE POSITIONS WE TOOK AT NCAI PRIOR TO MY COMING THERE BUT THAT WE CARRIED FORWARD WAS THAT WE TALKED WITH TRIBES ABOUT A NATIONS TO SAY WE ASSERT OR THAT TRIBES ASSERT SOVEREIGNTY OVER RESEARCH THAT HAPPENS ON THEIR LANDS, AND WITH THEIR CITIZENS, NO MATTER WHERE THEY HAPPEN TO LIVE. I KNOW THAT'S A CHALLENGING PIECE BUT I'M CURIOUS FROM YOU FOLKS AS WELL AS OTHERS, ARE THERE WAYS THOSE OF US IN POLICY AND ADVOCACY POSITIONS AND LEADERSHIP ROLES CAN ADVANCE THAT NOTION SO THAT IF THERE ARE NAVAJO CITIZENS IN LOS ANGELES COUNTY, WHICH WE KNOW THERE ARE AND RESEARCH IS BEING DONE, IF IT'S GOING TO BE REPORTED ON NAVAJO PEOPLE, THAT YOUR NATION HAS THAT AUTHORITY AND IS SUPPORTED BY ALL OF US. THOSE ARE TWO PIECES. THE THIRD WAS QUICKLY THE DATA PIECE. I'M SO GLAD WALTER, MR. PHELPS, YOU VISITED ALASKA, THE BIOBANK, I JUST WANT TO SAY THAT AND I'LL STOP AND LEAVE IT THERE. >> REGARDING A STUDY THAT IS BEING DONE OFF THE NAVAJO NATION, RESEARCHERS WILL CALL ME OR DIFFERENT HEALTH ORGANIZATIONS, FOR INSTANCE FROM PHOENIX, FOR INSTANCE PHOENIX CHILDREN'S HOSPITAL, THEY SAID THAT THEY HAD THEIR -- THEY HAD CHILDREN REFERRED TO THEM FOR MEDICAL CARE. AND WHAT HAPPENED IS THEY WENT BEYOND THAT AND THEY KEPT SOME OF THE SAMPLES. AND SO I TELL THEM THAT THEY SHOULDN'T BE DOING THAT BECAUSE IT'S UP TO THE NATION TO DECIDE WHO SHOULD TAKE SAMPLES OR NOT. AND SO WE'RE RECTIFYING THAT SITUATION. NOW, SOMETIMES THEY WERE OUT, THEY WILL CALL ME AS WELL AND SAY I'M DOING THE RESEARCH ON NAVAJO BUT IT'S NOT ON NAVAJO NATION, IT'S OFF THE NAVAJO NATION. SO DO I STILL HAVE TO GET APPROVAL? AND I SAID, I ALWAYS TELL THEM THAT THAT'S A QUESTION THAT YOU NEED TO ASK, AS A RESEARCHER, WHAT YOUR THOUGHTS ARE, AND WHAT YOU THINK OF THE NAVAJO TRIBE. WHEN YOU DECIDE TO MAKE YOUR DECISION, BEARING IN MIND IF YOU HAD A NAVAJO PARTICIPATE IN YOUR STUDY, AND THEY GOT HURT IN PHOENIX OR ALBUQUERQUE OR WHEREVER, THAT FAMILY WILL TAKE YOUR COLLEGE OR ORGANIZATION INTO TRIBAL COURT AND YOU'LL END UP IN TRIBAL COURT, BECAUSE THEY WON'T DO IT THROUGH THE STATE COURT. THEY WILL GO HOME AND SAY WE WANT TO TAKE THIS TO TRIBAL COURT. SO I SAID YOU MAY FIND YOURSELF DOING -- ENDING UP LIKE THAT. I SAID I WOULD BE VERY CAUTIOUS. SO OFTENTIMES THEY WILL CALL ME AND SAY, WE'RE GOING TO BE DOING A STUDY, AND I WOULD LIKE TO KNOW IF WE NEED TO GET APPROVAL FROM YOU AND I SAID, WHERE IS THE STUDY GOING TO BE AT? OFF THE NAVAJO. THEN THE NAVAJO NATION HAS NO TERRITORIAL JURISDICTION IN THAT MANNER BUT THIS COULD TAKE PLACE AND THIS COULD HAPPEN. SO THEN THEY WOULD SAY, CAN WE GET YOU TO REVIEW OUR PROTOCOL, TO MAKE SURE THAT WE'RE DOING THE THINGS THAT ARE RIGHT AND NOT DOING ANYTHING OFFENSIVE? AND SO OFTENTIMES THEY WILL SEND ME THE PROTOCOLS AND I'LL REVIEW THEM AND MAKE A SUGGESTION TO THEM AND SOMETIMES THEY LIKE FLAGSTAFF MEDICAL CENTER, THEY SENT THE DATA TO US. THEY SAID WE THINK IT'S IMPORTANT THAT YOU HAVE THE DATA. SO OFTENTIMES THAT HAPPENS. >> I JUST WANT TO THANK YOU FOR YOUR PRESENTATION AND THAT VALUABLE COMPONENT THAT CAUGHT MY EAR WAS THE CULTURAL PIECE FOR THE CEREMONIAL PEOPLE TO BE INVOLVED AND HAVE ACTUAL AUTHORITY THERE. I THINK THAT SOME OF OUR TRIBES ARE AT DIFFERENT CAPACITIES WHEN IT COMES TO IRBs TO RESEARCH, BUT SOME OF US ARE DIFFERENT CAPACITIES IN PRACTICING CEREMONIAL WAYS AND PRACTICING AND TRYING TO REVITALIZE SOME OF THESE TIME IMMEMORIAL TRADITIONS. THE WORLD VIEW THAT YOU'RE ABLE TO INCLUDE IN YOUR PROCESS, YOUR SYSTEM, IS IMPORTANT. I THINK THAT'S WHERE A LOT OF OUR TRIBES WANT TO LOOK AT HOW WE CAN THEN INCORPORATE THAT AT OUR HOME AND WHAT WE CAN DO WITH WHAT WE HAVE LEFT. SOME OF OUR TRIBES ARE LOSING, NOT ONLY OUR LANGUAGE, OUR CEREMONIES, BUT WE LOOK I THINK TO THE NAVAJO NATION AS A WELL-DEVELOPED SYSTEM THAT HAS COMPONENTS STILL IN PLACE, AND SO I REALLY APPRECIATE THAT PART AND THAT EMPOWERMENT THAT WAS GIVEN, THAT INHERENT SOVEREIGNTY, IF YOU WILL, THAT OUR CEREMONIAL PEOPLE HAVE WITHIN OUR TRIBAL GOVERNMENTS. I WANTED TO THANK YOU FOR THAT. >> JUST FOR YOUR INFORMATION, I JUST RECENTLY GOT -- RETURNED FROM MICHIGAN FROM THE SAGINAW CHIPPEWA TRIBE UP THERE TO HELP THEM DEVELOP THEIR IRB. AND I DID THE ONE IN HOPE NATION AS WELL AND SO I'M WORKING WITH MONTANA TO HELP THEM DEVELOP THEIR IRB. IT'S A VERY TWO-DAY INTENSE TRAINING. >> YEAH, WE GOT SHEEPDOGS UP THERE. [LAUGHTER] NOT SHEEP BUT SHEEPDOGS. [LAUGHTER] >> LET ME JUST ADD TO THAT, THE QUESTIONS. I THINK THERE'S A GAP WHEN IT COMES TO OFF-RESERVATION URBAN. IT'S NOT JUST THE NAVAJO. YOU KNOW, ALL DIFFERENT TRIBES. AND, YOU KNOW, THEY FALL THROUGH THE CRACKS AND, YOU KNOW, A LOT OF TIMES THERE'S NOBODY THERE TO TALK FOR THEM. AND IF THEY HAVE SOME OF THESE CONCERNS, THEY GET HURT, BEVERLY JUST MENTIONED WHO DO THEY GO TO? YOU KNOW, IT SEEMS TO ME LIKE SOMETHING HAS TO BE PUT IN PLACE FOR THESE TRIBES, MAYBE SOME KIND OF INTERTRIBAL ORGANIZATION. YOU KNOW, CONFEDERATED PLAN WHERE ALL TRIBES CAN BE ALSO PROTECTED ON SOME OF THESE RESEARCH ISSUES AND SO THAT'S A NEED OUT THERE. LIKE I SAID EARLIER, WE HAVE PEOPLE ALL OVER THE PLACE. YOU KNOW, WE HAVE A BIG POPULATION OF OUR PEOPLE IN LOS ANGELES, BIG POPULATION OF OUR PEOPLE IN PORTLAND, OREGON, OKLAHOMA, OUT HERE IN THE EAST COAST, AND THEY ARE EVERYWHERE NOW. I THINK IT'S TRUE FOR ALL TRIBES. AS AN ORGANIZATION HERE, NATIONAL INSTITUTES OF HEALTH TRIBAL ADVISORY COMMITTEE, MAYBE THIS IS SOMETHING THAT YOU COULD ENTER INTO THE FUTURE. THEN ALSO GOING BACK TO THE CULTURAL PIECE THAT WAS MENTIONED HERE, WHEN I BROUGHT SOME OF THESE GENETIC QUESTIONS TO ONE OF THE RECENT MEETINGS TO ONE OF THE SPIRITUAL AND CULTURAL SOCIETY, CALLED THE (INDISCERNIBLE) ASSOCIATION, COMPOSED OF ELDERS AND TRADITIONAL PEOPLE AND HEALERS, ONE SAID WE HAVE THE CAPACITY TO LOOK INTO A GENE. WE HAVE OUR OWN WAYS. SOMETIMES THOSE GENETIC DEFECTS, YOU KNOW, CAN GO BACK DOWN, GO BACK LIKE THREE OR FOUR OR FIVE GENERATIONS BACK. AND WE KNOW HOW TO TAKE CARE OF THAT NOW. THIS IS WHERE IT CAN END, SHOULD END. IT SHOULDN'T GO TO THE NEXT GENERATION. WE HAVE THAT CAPACITY. AND WITH OR WITHOUT TRIBAL LAW MORATORIUM WE'RE ALREADY DOING IT, YOU KNOW. WE DON'T NEED ANYBODY'S AUTHORIZATION. THAT'S WHAT THEY SAID. YOU KNOW, AND SO THESE ARE THINGS THAT, YOU KNOW, THAT WE -- THAT THEY TALK ABOUT AND ANOTHER ONE IS THE SOLAR ECLIPSE. THEY SAID, YOU KNOW, WE KNOW HOW TO FIX IT. AND THERE'S NO TREATMENT IN THE WESTERN -- IN THE WORLD, BUT WE KNOW HOW TO FIX IT. AND, YOU KNOW, ONCE THE DAMAGE IS DONE, IN THE BACK OF THE EYE, IT STAYS DAMAGED, BUT WE KNOW HOW TO FIX IT, YOU KNOW, SOME OF THE KNOWLEDGE, YOU KNOW, THEN IF IT COMES GENERATIONAL, YOU KNOW, THROUGH THE GENE PASSED THROUGH THE GENERATION WE KNOW HOW TO FIX THAT. SO, YOU KNOW, IT'S PRETTY INTERESTING, YOU KNOW, DIFFERENT SOCIETY. YOU KNOW, INTELLECTUAL KNOWLEDGE, YOU KNOW, THAT'S ALSO, YOU KNOW, INTELLECTUAL PROPERTY, RIGHT? ONCE YOU START GOING INTO THOSE AREAS, YOU KNOW, PEOPLE ARE NOT WILLING TO OPENLY SHARE THIS INFORMATION. FIRST QUESTION IS WHAT ARE YOU GOING TO DO, YOU KNOW, BECAUSE ONCE IT GOES OUT THERE IT'S SUBJECT TO ANALYSIS, YOU KNOW, NOT FROM THE NATIVE POINT OF VIEW AS UNDERSTOOD AND PRACTICED FOR YEARS BUT FROM A DIFFERENT POINT OF VIEW AND SO IT GETS DISSECTED AND AT THE END, YOU KNOW, IT BECOMES KNOWLEDGE THAT IS DOWNPLAYED. AND SO, YOU KNOW, IT'S NOT EASY, YOU KNOW, SHOULDN'T BE SHARED SO THAT'S OTHER INFORMATION I WANTED TO SHARE. >> WELL, THANK YOU BOTH VERY MUCH FOR BEING HERE TODAY AND SHARING YOUR KNOWLEDGE. WE APPRECIATE THAT VERY MUCH. I THINK NOW WE'RE A LITTLE BIT BEHIND. WE'RE GOING TO MOVE TO THE WORKING LUNCH SECTION. I DON'T THINK THE LUNCH PART IS HERE JUST YET BUT THEY WILL NOTIFY US. OH, IS IT IN THE BACK? HOW DO WE WANT TO DO THAT? KENDRA, TAKE A BREAK AND GRAB SANDWICHES AND GET STARTED? IF WE CAN DO THAT AND MAKE IT SNAPPY. THAT WOULD BE GREAT. >> THANK YOU VERY MUCH. I SINCERELY APPRECIATE THE COMMITMENT AND DEDICATION TO YOUR TRIBE THAT EACH AND EVERY ONE OF YOU HAVE SHOWN TODAY. WITH THAT KIND OF EXPERT INDIAN WE WILL BE ABLE TO MOVE FORWARD AS NATIVE AMERICANS. THANK YOU. [APPLAUSE] THE NEXT TOPIC IS NIH GENOMIC SHARING, DR. KHAIR HAS ARRIVED, PROMOTING SAFETY AND RESEARCH THROUGH THE OVERSIGHT OF TWO PRINCIPAL COMPONENTS, RESEARCH AND POLICY, HEALTH CARE RESEARCH POLICY. I'LL TURN IT OVER TO YOU. >> THANK YOU SO MUCH FOR THE OPPORTUNITY. I'VE BEEN IN THIS POSITION FOR FOUR MONTHS. THIS IS ONE OF THE MOST INTERESTING AND FASCINATING DISCUSSIONS I'VE HEARD. THANK YOU FOR THIS OPPORTUNITY AND THANK YOU FOR INCLUDING US IN THIS. I'M HOPING THIS CONVERSATION WILL CONTINUE BEYOND THIS MEETING, DEDICATED TO COMMUNICATING AND ANSWERING QUESTIONS. BEFORE I START I WANT TO SAY THE PRESENTATION WAS SO FASCINATING. WE NEED TO LISTEN, REALLY LISTEN. HAVING YOUR INPUT AND THINKING ABOUT IT, THINKING WHAT MATTERS, ABOUT YOUR CONCERNS AND HOPES, I THINK THAT WILL NOT JUST BE BENEFICIAL FOR TRIBAL COMMUNITIES BUT ALSO FOR NIH TO MAKE OUR POLICY MORE RESPONSIVE AND MORE RELEVANT. MOVING FROM THERE, I DIVIDED MY PRESENTATION INTO TWO SECTIONS, ONE ABOUT SINGLE IRB AND ONE ABOUT DATA SHARING, I TRIED TO END EACH WITH A SLIDE TO UPDATE YOU TO GIVE YOU SOMETHING NEW IN WHAT'S HAPPENING. BEFORE I START, YESTERDAY I WAS THINKING LIKE THE SINGLE IRB AND DATA SHARING IN GENERALLY IS A PART OF A LARGER EFFORT NIH HAS BEEN CARRYING ON FOR A WHILE. IT'S MORE RELATED TO THE ACTUAL CLINICAL TRIAL AND TRANSPARENCY REFORMS IN GENERAL. THIS IS THE LIFE CYCLE OF A CLINICAL TRIAL. WE HAVE THE LIGHT BULB INDICATING AN IDEA, AND SOMEBODY FROM THERE HAS TO APPLY USING FUNDING ANNOUNCEMENTS SPECIFIC TO CLINICAL TRIALS. THIS WAY WE HAVE THE RIGHT INFORMATION IN ONE PLACE AND WE PROVIDE ADEQUATE RESPONSIVE REVIEW FOR THE KIND OF STUDIES THAT INVOLVE HUMAN SUBJECTS. WE PROVIDED A TEMPLATE TO MAKE SURE ALL THE DETAILS REQUIRED TO BE THERE ARE PROVIDED AS WELL. THEN FROM THERE YOU HAVE THE SINGLE IRB POLICY THAT'S HOPING TO ACTUALLY MOVE FORWARD THE FIELD A LITTLE BIT, MORE EFFICIENT WAY, IF YOU WOULD. AND THEN OF COURSE DATA SHARING REALLY ENCOMPASSES ALL OF THIS. YOU HAVE EXPANDED THE CLINICAL TRIAL, RESULTS OF SUBMISSION POLICY. THE VALUE OF THE CLINICAL TRIAL, VALUE OF THE RESEARCH HAS TO BE TRANSPARENT TO PUBLIC, TO RESEARCHERS TO UTILIZE THIS DATA. PERSPECTIVES. ONE ITEM IS TO NOT ALLOW FOR REPLICATION OF STUDIES. AND TO ENSURE THAT SUCCESSFUL INTERVENTIONS MAKE IT TO ACTUAL PRACTICE. ALSO MOST IMPORTANTLY WHEN IT COMES TO DATA SHARING, BUILDING PUBLIC TRUST, THAT'S A REALLY IMPORTANT ELEMENT HERE. I DON'T WANT TO BELEAGUER THIS SECTION BUT I WANT TO MENTION THIS ARTICLE PUBLISHED BY DR. COLLINS, LAUER AND HUDSON, DETAILS HOW SERIOUS THE NIH IS ABOUT THIS ASPECT. SO I WANT TO MENTION ONE MORE THING ABOUT OUR COLLABORATION WITH THRO AND THANK DR. WILSON. WE ARE IN CONSTANT OR FREQUENT CONTACT WITH THRO AND MULTIPLE ASPECTS OF POLICY DEVELOPMENT AND I'M GOING TO MENTION SOME RELATED TO THE SINGLE IRB AND TO THE DATA SHARING. SO GOING INTO THE SINGLE IRB POLICY FOR MULTI-SITE RESEARCH, THE POLICY ESTABLISHES EXPECTATION SITES WILL USE SINGLE IRB OF RECORD TO CONDUCT ETHICAL REVIEW OF RESEARCH AND EFFECTIVE DATES FOR THIS WAS JANUARY 25, 2018. IF YOU'RE LOOKING ONLINE YOU MIGHT STUMBLE ON PREVIOUS DATES OF SEPTEMBER 25, 2017, AND THAT'S BEEN EXTENDED JUST TO MAKE SURE YOU KNOW ABOUT THAT. WHEN IT WAS PUBLISHED WE RECEIVED 167 COMMENTS INCLUDING COMMENTS FROM THE IHS, MULTI-SIDE STUDIES WITH CENTRAL IRB APPROVAL SHOULD BE REQUIRED TO SEEK APPROVAL FOR RESEARCH WITHIN JURISDICTION OF FEDERALLY RECOGNIZED A.I. OR TRIBES. THEY HIGHLIGHTED TRIBAL IRBs ENSURE RESEARCH IS CONDUCTED IN A COMMUNITY ENGAGED MANNER AND DOES NOT DIVERT LIMITED TRIBAL RESOURCES AWAY FROM THAT PATIENT CARE, AND THAT THE FINDINGS ARE FIRST SHARED WITH TRIBAL LEADERSHIP AND TRIBAL COMMUNITIES AND KEY STAKEHOLDERS. NIH POLICY DOES NOT APPLY TO TRIBAL POPULATIONS INCLUDING TRIBAL COLLEGES AND UNIVERSITIES, TO SHOW RESPECT FOR TRIBAL SOVEREIGNTY AND ACKNOWLEDGE IMPORTANCE OF FIRSTHAND KNOWLEDGE OF LOCAL TRIBE CUSTOMS, CULTURAL VALUE AND SENSITIVITY. THERE WERE TWO EXCEPTION, ONE IS WHERE WE VIEW WOULD BE PROHIBITED BY FEDERAL, TRIBAL OR STATE LAW, REGULATION OR POLICY, AND IF THERE'S COMPELLING JUSTIFICATION. THIS WAS IN ACKNOWLEDGMENT OF THE BENEFIT, IMPORTANCE OF TRIBAL REVIEWS ALLOWING FOR CONSISTENT RESEARCH PROTECTION FOR TRIBAL COMMUNITIES AND COOPERATION OF TRIBE-SPECIFIC VALUES IN RESEARCH POLICIES. CREATE CLEAR GUIDELINES AND PREVENT HARM TO COMMUNITIES AND ENSURE BENEFITS ARE RECEIVED BY TRIBES. FURTHER, THE GOAL OF HAVING ROBUST PROCESS THAT ENSURES CONDUCT OF CULTURALLY COMPETENT AND ETHICAL RESEARCH. SO THERE ARE MULTIPLE RESOURCES AVAILABLE TO THE COMMUNITY INCLUDING FROM THRO, AND ALSO FROM THE CRCAIH TOOLKIT AVAILABLE ONLINE, NICELY LISTED TOOLKIT. I WANT TO COME BACK TO OUR OFFICE COLLABORATION WITH THRO BECAUSE WE SEE THIS COLLABORATION AS ESSENTIAL TO OUR EFFORTS. WE WORKED WITH OUR SISTER OFFICE, OFFICE OF EXTRAMURAL RESEARCH ON THE IMPLEMENTATION ASPECT AND I BELIEVE A MEMBER OF THAT OFFICE IS WITH US TODAY IF YOU HAVE QUESTIONS LATER ON. SO ONE ITEM WE'RE WORKING WITH THRO RIGHT NOW ON IS DEVELOPMENT OF FACT SHEET AND FAQs FOR STUDIES WITH TRIBAL POPULATIONS, SPECIFIC TO THE SINGLE IRB POLICY. AND ONE ITEM, FOR EXAMPLE, TRYING TO EXPLAIN VERY CLEARLY IN THOSE, THAT IF YOU HAVE A MULTI-SITE TRIAL THAT INCLUDES SIDES IN TRIBAL COMMUNITIES AND OTHER SIDES OUTSIDE OF THEM WITH WOULD THE POLICY APPLY. NO, IT DOESN'T APPLY TO THE SITE WITHIN THE TRIBAL COMMUNITIES. A LOT OF QUESTIONS OF THAT TYPE WILL BE CLARIFIED HOPEFULLY THROUGH THE FAQs. THE FACT SHEET IS MORE SPECIFIC TO GETTING INFORMATION ABOUT THE BACKGROUND, THE HISTORY, AND ALSO THE FORMS OF IRB THAT ARE KNOWN INCLUDING IHS IRB AND TC IRB. THIS IS JUST ONE EXAMPLE OF CONSULTATION SESSION. WE SEE QUESTIONS CONCERNING NIH POLICY THAT REQUIRE REGISTRATION AND RESULTS OF COMMISSION OF CLINICAL TRIALS, WOULD THAT APPLY TO CLINICAL TRIALS ON TRIBAL SITES AND IF THERE IS ANY WAIVER MECHANISM. I WANT TO MENTION WE RECEIVED THAT QUESTION AND DISCUSSED IT WITH OUR COLLEAGUES AND CONTINUE TO DISCUSS IT WITH THRO AS WELL. I HAVE ADDITIONAL INFORMATION IF YOU'RE INTERESTED, I DON'T WANT TO TAKE THE TIME FROM ADDRESSING THIS NOW. MOVING INTO DATA SHARING, THIS IS A LONGSTANDING POLICY OF NIH, NIH EXPECTS RESULTS AND ACCOMPLISHMENTS OF ACTIVITIES THAT IT FUNDS TO BE MADE AVAILABLE TO THE PUBLIC. BOTH INVESTIGATORS AND ORGANIZATIONS ARE EXPECTED TO MAKE RESULTS AND ACCOMPLISHMENTS OF THEIR ACTIVITIES AVAILABLE FOR THE RESEARCH COMMUNITY AND TO THE PUBLIC AT LARGE. WE SEE THIS AS REALLY AN ESSENTIAL ASPECT OF WHAT WE DO. THIS IS HOW WE SEE THE VALUE OF WHAT WE DO AND HOW PUBLIC HEALTH CAN BE TRANSFORMED BY THE RESEARCH THAT WE FUND. FOR EXAMPLE SPECIFICALLY WITH CLINICAL TRIALS PREVENTS REPLICATION OF BAD RESEARCH ENSURING GOOD RESEARCH MAKES IT TO PRACTICE. AND ALSO SHOWS THE WHOLE PUBLIC IN GENERAL THAT OUR RESEARCH IS MAKING A DIFFERENCE AND HERE IS THE DETAIL AND THIS IS IMPORTANT FOR PUBLIC TRUST REASONS AS WELL. BUT ALL THAT SAID, THIS IS ALL CONSISTENT WITH INFORMED CONSENT, THAT OVERALL. SO WHY DOES AN INCREASED INTEREST IN DATA SHARING A LOT OF YOU HEARD A LOT ABOUT THAT THIS MORNING. I WANT TO HIGHLIGHT A FEW OTHER ITEMS, SCIENCE INCREASINGLY DIGITAL, GENERATING VAST AMOUNTS OF DATA, JOURNAL PUBLICATIONS BECOMNG MORE DIGITIZED, NO PRINT ANYMORE, DATA COLLECTED CAN BE USED FOR MULTIPLE PURPOSES, INCLUDING PATIENT CARE DATA. VANDALSES ADVANCES MAKE IT EASIER TO COLLECT, ORGANIZE AND ACCESS AND ANALYZE DATA, CHANGING TOWARD MORE OPEN AND TRANSPARENT DATA SHARING. THERE ARE MULTIPLE INITIATIVES, THE 2013 WHITE HOUSE INITIATIVE, BD2K FOR BROAD USE OF DIGITAL ACCESS AND THE COMMON RULE HAS SPECIFIC PROVISION. HISTORICAL BACKGROUND OF HOW NIH SEES THIS AS A CULTURE OF SHARING. SHARING IS ESSENTIAL FOR WHAT WE DO AND HERE ARE MULTIPLE ELEMENTS THAT SHOWS WHAT WE'VE BEEN DOING OVER THE YEARS IN THAT REGARD. SO SAYING THAT, THE GDS IS A GREAT EXAMPLE, WE TRY TO PROVIDE SOME KIND OF MATERIALS TO EXPLAIN ISSUES, TO HELP THE COMMUNITY UNDERSTAND WHAT WE'RE TRYING TO MEAN. THERE WAS GOING TO CONSIDER, FOR EXAMPLE, FOR THE IRBs, PROVIDED WITH GDS POLICY AND ALSO THIS DOCUMENT INDICATES RESEARCH IN TRIBAL POPULATIONS AND AUTHORIZED INSTITUTIONAL INSTITUTIONS TO CONSIDER TRIBAL LAWS WHERE IT MAY BE APPROPRIATE IN ADDITION TO LANGUAGE IN THE POLICY THAT REQUIRES CONSISTENCY WITH TRIBAL LAW. THIS IS KIND OF WHAT'S HAPPENING RIGHT NOW, IF YOU WOULD. WE HAVE A WORKING GROUP THAT'S WORKING ON LOOKING AT THE SCOPE AND APPLICABILITY FOR EXISTING NIH DATA SHARING POLICIES AND HOW WE CAN ADVANCE THAT, LOOKING INTO SPECIFIC REQUIREMENTS HOW TO EVALUATE DATA MANAGEMENT AND SHARING PLANS FOR REVIEW AND MAKE DATA MACHINE READABLE AND UPDATABLE AND PUBLICLY AVAILABLE, REQUIRES DATA SHARING, LOOKING INTO LAWS THAT REQUIRE DATA SHARING, 21ST CENTURY CURES ACT PROVISIONS THAT ENHANCE DATA SHARING IN GENERAL. ALL THIS RECOGNITION WITH ABILITY TO PROVIDE JUSTIFICATION OF DATA MANAGEMENT AND SHARING PLANS FOR WHY CERTAIN DATA CANNOT BE SHARED IS ALWAYS AVAILABLE HERE. I WANT TO END HERE AND MOVE TO SARA, HER PRESENTATION FLOWS NICELY AFTER MINE AND HOPEFULLY AFTER THAT CAN TAKE QUESTIONS FROM YOU. >> THANK YOU. THIS IS THE SPACE MY NIH IRB USES FOR OUR TRAINING RETREATS, SEE WE'VE GRAPPLED WITH OUR IRB HERE IN THIS ROOM. SO IT FEELS RIGHT TO BE HERE. AND I REALLY APPRECIATE THE OPPORTUNITY TO PICK UP WHERE DR. ELZARRAD AND THE CONVERSATION WENT, I'M GRATEFUL TO BE POSITIONED HERE AND TO HAVE HAD THE OPPORTUNITY TO HEAR THE DISCUSSIONS THIS MORNING. I LEARNED A GREAT DEAL AND I HOPE TO BE ABLE TO WEAVE IN SOME OF THE QUESTIONS AND SOME THEMES TO MY TOPICS AND SO I'M GOING TO TRY TO ADJUST ON THE FLY AS WE'RE GOING THROUGH. BUT THE LAST TIME YOU INVITED ME TO SPEAK TO THE TRIBAL ADVISORY COMMITTEE, YOU ASKED ME TO GIVE AN UPDATE ON OUR EFFORTS TO EXPANDS TRAINING AND CAPACITY BUILDING OPPORTUNITIES AROUND TRIBAL IRBs, AND THE OVERSIGHT OF TRIBAL RESEARCH, AND I JUST DID WANT TO REASSURE YOU WE'RE MAKING GOOD PROGRESS, WITH THOSE PROGRAMS, OUR PARTNERSHIPS WITH PRIMER, NCAI AND OTHER PARTNERS, NEW PROGRAMMING COMING OUT, YOU RECEIVED E-MAILS ABOUT SOME UPCOMING EVENTS AND WE ALSO I'M VERY PLEASED WERE ABLE TO RECRUIT NOW FOURTH NATIVE PARTICIPANTS IN OUR INTERNSHIP PROGRAM HERE ON THE INTRAMURAL RESEARCH CAMPUS, YOU MET THIS MORNING KIMBERLY PAUL, WHO IS FOLLOWING IN TRADITION OUR FIRST INTERN IS ALSO HERE, DR. DINA AROUNDHIM, AND KIM WILL JOIN FOUR INTERNATIONAL TRAINEES FROM ALL OVER THE WORLD THIS FALL AND I'VE ALREADY LEARNED A GREAT DEAL FROM WORKING WITH HER SO I'M VERY CLEAVED ABOUT -- PLEASED ABOUT THAT. THIS ISN'T THE TOPIC YOU ASKED ME TO PRESENT ON BUT I SEE IT AS VERY MUCH RELATED TO WHAT YOU HAVE ASKED ME TO SPEAK ON BECAUSE IT SUPPORTS THE IDEA OF NIH BEING ABLE TO SUPPORT TRIBES IN THEIR EXPRESSION OF SOVEREIGNTY, AND I SEE TRIBAL IRB REVIEW AS A VERY IMPORTANT EXPRESSION OF YOUR SOVEREIGN ABILITY TO GOVERN RESEARCH IN YOUR COMMUNITIES. AND IT'S REALLY IMPORTANT FOR US AT THE NIH TO REMEMBER THAT THAT'S VERY RELEVANT, AS WE'RE THINKING ABOUT THE RELATIONSHIP BETWEEN OUR NIH RESEARCH POLICIES AND TRIBAL RESEARCH. SO THAT'S A THEME THAT I WANT TO TRY TO COME BACK TO AND HAVE US BE FOCUSED ON AS WE'RE TALKING ABOUT THESE ARE POLICIES. I'M SPEAKING AS THE CHAIR ON REVIEW OF GENETIC RESEARCH RESEARCH PROTOCOLS, MANY ACROSS THE WAY IN THE CLINICAL CENTER. MANY OF THE STUDIES FOCUS ON RARE GENETIC CONDITIONS WITH SOMETIMES A HIGHER PREVALENCE IN UNDERSERVED, BUT LIKE DIABETES ON POPULATIONS AROUND THE WORLD. NONE OF THOSE STUDIES HAVE TAKEN PLACE IN TRIBAL POPULATIONS, SO WITH YOU ARE MODELS AND ANALOGIES TO SOME EXTENT, NOT EXACTLY ON POINT BUT LIKE A LOT OF RESEARCH IN THE INTRAMURAL RESEARCH PROGRAM, IT'S SUPPOSED TO BE -- IT'S OFTEN MODEL STUDIES, MODELS AND HIGHER RISK KINDS OF STUDIES TO PROVIDE AN EXAMPLE TO BROADER COMMUNITY SO I HOPE BY ANALOGY SOME EXAMPLES I CAN SHARE WITH YOU MAY BE USEFUL AS YOU THINK ABOUT WORK, IN THE FLEXIBILITY. IT'S IMPORTANT TO FRAME THIS WITH AWARENESS AND KNOWLEDGE GAINED FROM THE EXPERIENCES OF CASES, HARMFUL, WITH TRIBAL COMMUNITIES AND WHAT LESSONS ARE WE NEED TO KEEP IN MIND. THE HAVASUPI CASE, I'VE HEARD THIS GROUP MENTION, IS ONE THAT PROMPTED SCHOLARSHIP, THE HASTINGS CENTER REPORT IS AN IMPORTANT BIOETHICS PUBLICATION THAT RESONATED WITH ME. I WANTED TO SHARE THIS QUOTE BECAUSE I THINK IT'S VERY USEFUL FOR FRAMING OUR DISCUSSION. THEY ARGUE WHAT'S HAPPENING WITH ALL OF THESE CASES ILLUSTRATES THAT THERE'S A PROFOUND DISCONNECT BETWEEN COMMON ACADEMIC RESEARCH PRACTICES AND LEGITIMATE TRIBAL EXPECTATION, COMMUNE EXPECTATION, AND THAT JUSTICE REQUIRES THAT THIS GAP BE BRIDGED. SO THE COMMON RULE, NIH RESEARCH POLICIES, THESE ARE THE COMMON ACADEMIC RESEARCH PRACTICES THAT WE APPLY TO THE MAJORITY OF RESEARCH HERE. TRIBES HAVE SOVEREIGNTY AND THEY HAVE REASONABLE COMPLAINTS AND REASONABLE CONCERNS AND INTEREST IN PROMOTING THE GOOD OF THEIR COMMUNITIES. AND THEY TALK ABOUT PRINCIPLE OF JUSTICE DIFFERENTLY THAN THE BELMONT REPORT, RESTORATIVE JUSTICE, GETTING BACK TO HONORING TRIBAL SOVEREIGNTY AS A WAY TO BRIDGE THAT GAP. I THINK WE'VE MADE SOME PROGRESS IN DOING THAT SINCE 2008. I THINK IS THERE IS EVIDENCE IN SOME POLICIES AT LEAST OF AN INTENTION TO TRY TO BRIDGE THAT GAP. SO DR. WILSON MENTIONED EARLIER, THIS IS THE FINAL PDF VERSION OF THE PUBLICATION WE COLLABORATED ON TOGETHER THAT CAME OUT THIS SUMMER IN RESPONSE TO THE NEW COMMON RULE CHANGES, AND ALTHOUGH MANY OF US WERE DISAPPOINTED THAT THOSE CHANGES AND THE SUPPORTING DOCUMENTS DON'T EXPLICITLY CALL OUT AN ETHICAL PRINCIPLE THAT FOCUSES ON PROTECTING COMMUNITIES FROM HARM IT'S IMPORTANT TO RECOGNIZE THERE'S NEW LANGUAGE WE NEED TO FOCUS ON IN THE COMMON RULE THAT MENTIONS THAT ACKNOWLEDGES TRIBAL SOVEREIGNTY, ABILITY OF TRIBES TO SET POLICIES THAT OFFER ADDITIONAL PROTECTION BEYOND THE COMMON RULE AND THE COMMON RULE IS NOT INTENDED TO REPLACE THOSE IN ANY WAY. WE NEED TO RECOGNIZE THEM. SO IT'S IMPORTANT FOR PEOPLE TO REALIZE THAT SO WE CAN START TO TAKE THAT INTENTION AND ACTUALLY OPERATIONALIZE IT IN PRACTICE. SO THAT'S SOME OF THE ARGUMENT WE WERE TRYING TO MAKE HERE. WE ALSO -- WELL, WE ALSO ENTERED INTO THE MEETING TWO WEEKS AGO. I WAS EXTRAORDINARILY PRIVILEGED TO BE AMONG SOME OF THE NIH REPRESENTATIVES ABLE TO ATTEND THE TRIBAL DATA SHARING AND GENETICS WORKSHOP IN ALBUQUERQUE, AND WHEN DR. WILSON SAYS IT WAS A TRANSFORMATIVE EXPERIENCE FOR HIM, THAT'S THE TERM I WAS THINKING OF AS WELL. REALLY PROFOUNDLY HUMBLING AND HONORED TO SIT AND LISTEN AND WITNESS THE PROCESS OF POLICY DEVELOPMENT IN THE NAVAJO NATION AND THAT THEY WERE QUITE WELCOMING AND RECEIVED US SO WARMLY THEY ACTUALLY RECOGNIZED US AND HAD US STAND UP TWICE, SPECIAL TO BE THERE, I LEARNED A TREMENDOUS AMOUNT BUT I'M STILL WORKING THROUGH. I WANTED TO COME BACK AND SHARE ONE REALLY VALUABLE THING THAT I HEARD FROM A SPEAKER. DR. MICHELLE CON JOHN, A COMPELLING SPEAKER, TRAINED AS A PSYCHIATRIC NURSE, AND SHE'S A MEMBER OF THE DE NATALE ASSOCIATION, AND POINT THE US TO A DOCUMENT, AMERICAN INDIAN ALASKA NATIVE CULT CAL WISDOM DECLARATION, SOME PEOPLE AROUND THIS TABLE MAY HAVE BEEN INVOLVED IN CREATING OR WERE SIGNATORIES OF. IT'S A SERIES OF RECOMMENDATIONS DIRECTED AT FEDERAL AGENCIES AND OTHERS IN A POSITION TO HELP TRIBAL COMMUNITIES ADDRESS SIGNIFICANT HEALTH ISSUES INCLUDING BEHAVIORAL HEALTH IN THIS CASE BUT I THINK IT'S REALLY APPLICABLE TO OTHER SITUATIONS, AND THIS ONE PARTICULAR RECOMMENDATION I THINK SPEAKS DIRECTLY TO WHAT WE NEED TO DO HERE. MODIFY YOUR REQUIREMENTS TO FIT THE RELEVANT TRIBAL PARADIGM OR ALLOW ROOM FOR FLEXIBILITY WHEN EVALUATING PROPOSALS SUBMITTED BY AMERICAN INDIAN AND ALASKA NATIVE TRIBAL NATIONS. AND SO IF I COULD TRY TO JUST PUT THAT IN MY OWN WORDS, I WOULD SAY THE QUESTION WE'RE EXPLORING HERE IS ARE NIH POLICIES FLEXIBLE ENOUGH TO PERMIT COLLABORATIVE RESEARCH AND DATA SHARING TO TAKE PLACE IN PARTNERSHIP WITH SOVEREIGN TRIBAL NATIONS? AND I'M NOT GOING TO HIDE THE BALL. WE HAVE TO GET TO SAYING THE ANSWER TO THE QUESTION IS YES, AND I THINK WE HAVE TO DO THAT THROUGH SOME TARGETED CASE STUDIES I THINK YES IN INSTITUTES MAKE DIFFERENT DECISIONS FROM EACH OTHER AND I ALSO SAY EXTRAMURAL SOMETIMES MAKES DIFFERENT DECISIONS FROM INTRAMURAL SO THERE'S VARIABILITY BUT INDIVIDUAL PROGRAMS DO HAVE THE DISCRETION TO APPLY THE FLEXIBILITIES THAT EXIST IN THESE POLICIES AND SO I'M AN IRB CHAIR, I WAS HIRED TO HELP THE NIH DO THE ETHICAL AND THE RIGHT THING SO I'M GOING TO GO OUT ON A LIMB AND SAY THIS IS WHAT WE NEED TO DO AND I WANT TO, YOU KNOW, ENCOURAGE MY COLLEAGUES TO WORK IN PARTNERSHIP TO GET TO THIS. NOW LET ME GET TO THE SPECIFIC POLICIES. THERE'S TWO POLICIES I WAS ASKED TO ADDRESS TOGETHER WITH DR. ELZARRAD. HE DID SUCH A NICE JOB HE'S GOING TO SAVE ME TIME. THE SINGLE IRB POLICY DOESN'T TAKE EFFECT UNTIL JANUARY OF NEXT YEAR. AND GENOMIC DATA SHARING POLICY HAS BEEN IN EFFECT SINCE 2015. WE HAVE A LITTLE BIT OF EXPERIENCE UNDER OUR BELTS WITH THAT ONE AND ALSO WITH THE GWAS DATA SHARING POLICY THAT PRECEDED IT AND I THINK WAS IN EFFECT SINCE SOMETHING LIKE 2008. I'M GOING TO SAY MORE ABOUT THE LATTER. TO REVIEW THE NIH POLICY ON USE OF A SINGLE IRB FOR MULTI-SITE RESEARCH YOU SHOULD ADMIT TO YOU MY IRB SERVES AS SINGLE IRB OF RECORD FOR MULTI-SITE STUDY, I HAVE THE EXPERIENCE OF ACTING ON BEHALF OF A CONSORTIUM STUDY. IT'S THE UNDIAGNOSED DISEASES NETWORK WHICH STARTED OUT AS A PROGRAM SORT OF A PILOT PROJECT IN THE INTRAMURAL RESEARCH PROGRAM HERE, SO SUCCESSFUL IT BECAME A MULTI-SITE STUDY, AND MY IRB IS THE IRB OF RECORD SO I KNOW WHAT THAT LOOKS LIKE. THAT WAS BEFORE THIS POLICY WAS IN PLACE. BUT I'VE ALSO BEEN VERY INTERESTED TO SEE HOW WE WOULD BE ABLE TO ARTICULATE AND HONOR THE EXCEPTIONS THAT ARE BUILT INTO THE POLICY AROUND TRIBAL COMMUNITIES BECAUSE I HAVE A MUCH BETTER UNDERSTANDING NOW MUCH THE IMPORTANCE OF TRIBAL IRBs THROUGH OUR TRAINING PROGRAM AND THROUGH A LOT OF THE CONVERSATIONS THAT I'VE BEEN ABLE TO LISTEN IN ON. SO THE POLICY CLEARLY STATES THAT IT IS INTENDED NOT TO APPLY WHERE THERE'S REQUIREMENT FOR TRIBAL IRB REVIEW AND WE JUST HEARD THAT. AND I'M HEARTENED ABOUT ALL THE EFFORTS BETWEEN OST AND TRIBAL RESEARCH OFFICE TO ARTICULATE WHAT IS ENCOMPASSED WHEN WE SAY A TRIBAL LAW REGULATION OR POLICY, NOT JUST A FEDERALLY RECOGNIZED TRIBE NECESSARILY, TRIBAL COLLEGES AND UNIVERSITIES, DIFFERENCE BETWEEN RESERVATION AND URBAN JURISDICTIONS, ET CETERA, ALL THAT BEING SORTED OUT. THAT IT'S WHY THAT FAQ WILL BE HELPFUL. IN OTHER CASES THAT AREN'T PRE-RECEIVED WITH A COMPELLING JUSTIFICATION, I'VE BEEN INVOLVED IN DISCUSSION TO SET UP A COMMITTEE OR GROUP THAT WILL HELP EVALUATE THOSE, IF ANYTHING IS MISSING THERE'S A MECHANISM TO CAPTURE THOSE. HOW DO WE HONOR THOSE EXCEPTIONS AND HOW DO RESEARCHERS UNDERSTAND THEIR OBLIGATIONS, HOW TRIBES UNDERSTAND HOW TO EXERCISE THEIR SOVEREIGNTY AND THEIR ABILITY TO OPERATE UNDER THIS POLICY TO APPROPRIATELY CLAIM THE KINDS OF REVIEW THAT THEY WANT TO BE ABLE TO HAVE TO PROTECT THEIR COMMUNITIES. I WANT TO REFERENCE THIS REMEMBER NAVAJO REFERENCE THIS WEBINAR, WHEN I CAME IN IN 2015 I REFERENCED IT WOULD BE HAPPENING. IT'S HAPPENED. A GREAT CONVERSATION BETWEEN FEDERAL POLICY FOLKS AND FOLKS AT THIS TABLE, SOME TRIBAL POLICY LEADERS AND RESEARCHERS ABOUT WHAT THIS COULD LOOK LIKE IN PRACTICE AND WE TOOK A LOT OF QUESTIONS FROM THE COMMUNITY AND TRIED TO ADDRESS THEM. THAT'S ALL BEEN ARCHIVED AT THE LINK THERE. SO I WOULD ENCOURAGE YOU TO LOOK AT THAT. I WOULD ENCOURAGE US TO CONTINUE THOSE CONVERSATIONS BECAUSE I THINK EDUCATION WILL BE A KEY COMPONENT. ALL RIGHT. ON TO THE GENOMIC DATA SHARING POLICY, I'M DELIBERATELY SHARING THIS COMPLICATED DIAGRAM TO MAKE A POINT. FIRST I WANT TO SAY WHAT IT IS. IT'S A SCHEMATIC THAT WALKS US THROUGH WHAT THE NIH GENOMIC DATA SHARING POLICY USUALLY LOOKS LIKE IN PRACTICE. IT STARTS WITH THE IDEA OF ENROLLING RESEARCH PARTICIPANTS, GETTING THEIR INFORMED CONSENT, COLLECTING THEIR DATA, AND ONCE THOSE DATA ARE COLLECTED IF THEY FALL -- IF SEQUENCING DATA FALLS UNDER THE POLICY, THE RESEARCHER WILL REMOVE INDIVIDUAL IDENTIFIERS, CERTIFY IT AND DEPOSIT IT INTO ONE OF THE NIH REPOSITORIES, AND THEN DATA ACCESS COMMITTEE WILL REVIEW AN INVESTIGATOR'S REQUEST TO USE THE DATA FOR SECONDARY RESEARCH. IT'S CLEAR THAT WAY. THIS IS A NICE EXAMPLE OF THE DISCONNECT BETWEEN NIH COMMON ACADEMIC PRACTICE AND A PERSPECTIVE ON COMMUNITIES. THERE'S NOTHING ABOUT COMMUNITIES REPRESENTED IN THE DIAGRAM. DO I HAVE A POINTER THAT I CAN USE? NO. ON THE LEFT-HAND SIDE, THERE'S NO PRIOR ENGAGEMENT WITH THE COMMUNITY INDICATED. IT MIGHT BE AN INTENTION BUT IT'S NOT INDICATED ON THE ILLUSTRATION, THERE'S NO ATTENTION PAID TO RETURN OF RESULTS, NO CHECK-IN OR GOVERNANCE OR OVERSIGHT ALONG THE WAY. HONESTLY THE PUBLIC NOTICED THIS. THERE WAS A PUBLIC COMMENT PERIOD FOR THE DRAFT POLICY, AND THE COMMENTS SUBMITTED SOUNDED SOMEWHAT SIMILAR TO THE COMMENTS THAT WERE OFFERED BY ONE MEMBER OF HIS COMMUNITY, OF DR. BEGAY'S COMMUNITY, ABOUT THE IDEA OF DATA SHARING. ONCE DATA ARE SUBMITTED TO REPOSITORY THERE'S NO OPPORTUNITY FOR A COMMUNITY TRIBAL LEADERSHIP OR LOCAL IRB TO BE INVOLVED IN DECISIONS REGARDING DATA USE OR THIS SCHEMA CONTRADICTS PRACTICE OF COLLABORATIVE RESEARCH BASED ON PARTNERSHIP EFFORT BETWEEN TRIBAL GOVERNMENTS AND RESERVERS, AND COMMUNITIES ARE WARY OF DELEGATING ASSESSMENT OF CULTURAL AND OTHER KINDS OF HARMS TO A DATA ACCESS COMMITTEE MADE UP OF SENIOR NIH OFFICIALS. THERE WAS SKEPTICISM ABOUT EXPERTISE OF PEOPLE ON THE COMMITTEES MAKING THE DECISION ABOUT WHAT KINDS OF SECONDARY RESEARCH CAN BE DONE. I WOULD LIKE TO SUGGEST THE FINAL POLICY THAT CAME OUT IS RESPONSIVE TO THESE CONCERNS OR HAS POTENTIAL TO BE. IT EXPRESSES THE INTENTION TO BE RESPONSIVE TO POLICIES. WE JUST HAVE TO BE ABLE TO ACT ON THOSE. HERE IS SOME OF THE FLEXIBILITIES THAT ARE BUILT INTO THE POLICY LANGUAGE. LET ME GIVE A LITTLE BIT OF MORE BACKGROUND ABOUT MY ROLE IN DATA DEPOSITION, IF AN INVESTIGATOR FROM MY INSTITUTE IS GENERATING GENOMIC SEQUENCING DATA THAT FALLS UNDER THE POLICY, SHE WILL COMPLETE AN INSTITUTIONAL CERTIFICATION DOCUMENT THAT I AS A REPRESENTATIVE OF THE IRB HAVE TO SIGN OFF ON BEFORES THOSE DATA WITH BE DEPOSITED, GIVING ME OBLIGATIONS TO MAKE SURE THE DEPOSITION IS OKAY. THE POLICY SUGGESTS THAT I NEED TO MAKE SURE THAT DATA SUBMISSION IS CONSISTENT AS APPROPRIATE WITH APPLICABLE TRIBAL LAWS THAT I HAVE TO BE KNOWLEDGEABLE ABOUT THOSE LAWS AND WHERE THEY APPLY. I HAVE TO PAY ATTENTION TO ANY LIMITATIONS ON SUBSEQUENT USE OF THOSE DATA THAT MIGHT BE SPECIFIED IN THE PROTOCOL AND ESPECIALLY IN THE CONSENT FORM. AND THEN THIS ONE IS BOTH CRITICAL AND HAS INTERESTING WORDING ATTACHED TO IT. TO THE EXTENT RELEVANT AND POSSIBLE, I'M SUPPOSED TO GIVE CONSIDERATION TO RISK TO GROUPS OR POPULATIONS ASSOCIATED WITH SUBMITTING THE DATA TO THE REPOSITORY. IT'S A REALLY IMPORTANT POINT BUT I WILL ADMIT THAT MY ABILITY TO ASSESS THE RISKS THAT ARE PERTINENT TO DIFFERENT COMMUNITIES IS LIMITED AND SO AT BEST WHAT I CAN DO SOMETIMES IS INSIST THAT WE NEED TO DEFER TO A LOCAL IRB WHO IS MORE FAMILIAR WITH THAT COMMUNITY THAT I CAN RELY ON TO HELP ME WITH THAT ASSESSMENT. THIS IS CAPTURED IN THE POLICY. THIS IS WHAT WE'RE SUPPOSED TO BE DOING WHEN WE CERTIFY DATA DEPOSITION. AND PERHAPS IT'S BECAUSE I'M IN THE INTRAMURAL RESEARCH PROGRAM, IT'S PERHAPS BECAUSE OF THE PARTICULAR KIND OF STUDIES WE REVIEW, BUT WE'VE BEEN ABLE TO ENACT SOME FLEXIBILITY, SOME OF THESE THAT WE HAVE OPERATIONALIZED, SOME DATA USE LIMITATIONS AND THESE -- I FORGOT THERE IS ONE MORE IMPORTANT ONE, THE EXCEPTION. THIS IS THE CRITICAL ONE. LIMITED EXCEPTIONS ARE PERMITTED UNDER GENOMIC SHARING POLICY FOR DEPOSITION OF THESE DATA INTO AN NIH REPOSITORY, IN CASES WHERE DATA SUBMISSION IS JUST NOT APPROPRIATE. THE INVESTIGATOR CAN PROVIDE A JUSTIFICATION, THE CHAIR SIGNS OFF AND GETS SIGNED OFF BY LEADERSHIP. WE CAN APPROVE EXCEPTIONS. SOMETHING WAS ASKING ABOUT THE IDEA OF A WAIVER, I THINK THAT'S WHAT THIS IS B I THINK IT'S NOT ACTUALLY QUITE A WAIVER, IT'S COVERED BY THE POLICY. I THINK THAT'S ANALAGOUS TO WHAT A WAIVER MEANS BUT WE CAN COME BACK AND DISCUSS THAT AND MAYBE COLLEAGUES CAN FLESH THAT OUT. SO HOW MIGHT THIS WORK? I'VE GOT A COUPLE SPECIFIC EXAMPLES I'LL WALK THROUGH QUICKLY SO YOU CAN SEE BY THE ANALOGIES. ONE OF THE STUDIES WE REVIEWED, GENETIC VARIATION IN ADULT PARTICIPANTS WITH SICKLE CELL DISEASE, EVEN THOUGH IT'S A SINGLE GENE DISORDER, MANY PEOPLE WITH THE CONDITION HAVE VERY DIFFERENT MANIFESTATIONS, AND SO THIS IS A STUDY TO DELVE INTO THE GENOMICS AND TRY TO UNDERSTAND WHY SOME PEOPLE WITH SICKLE CELL DISEASE DEVELOP ULCERS OR HAVE OTHER COMPLICATIONS, AND THE STUDY FALLS UNDER THE GENOMIC DATA SHARING POLICY BUT THE INVESTIGATOR IS VERY FAMILIAR WITH THE PERSPECTIVE OF THE COMMUNITY THAT HE'S RECRUITING FROM WHICH IS PRIMARILY AN AFRICAN-AMERICAN POPULATION, AND HE'S AWARE OF BOTH THE MISTRUST THAT COMMUNITY HAS WITH SOME HISTORICAL -- BASED ON HISTORICAL RESEARCH PRACTICES, AND THERE ARE CONCERNS THAT THIS HAS BEEN AN UNDERSTUDIED DISEASE, EVEN THOUGH AMONG THE FIRST GENETIC DISORDERS WHERE WE UNDERSTOOD THE GENETIC BASIS, THERE'S SOME -- TREATMENT HAS LONG TIME BEEN ELUSIVE SO THERE'S A REAL COMMITMENT TO RESEARCH ON SICKLE CELL DISEASE, A CONCERN ABOUT THEIR DATA BEING USED FOR OTHER, AND I CONVINCED THE IRB OF THIS AND WE APPROVED DATA USE LIMITATIONS, THIS IS DESCRIBED IN THE CONSENT FORM, THIS WENT THROUGH THE CERTIFICATION PROCESS AND NOW -- THOSE DATA WILL BE -- WILL OR HAVE BEEN DEPOSITED IN dbGAP AND WHEN A SECONDARY RESEARCHER WANTS TO ACCESS THEM THEY WILL HAVE TO CERTIFY THEY WILL ONLY USE THEM TO FURTHER THE STUDY OF SICKLE CELL DISEASE. ALTERNATIVE DATA SHARING PLANS, HERE IS WHERE I THINK THERE'S BROAD LATITUDE TO UTILIZE NOT ONLY DATA USE LIMITATIONS, THERE COULD BE OTHER KINDS OF LIMITATIONS REQUIRING THINGS LIKE ADDITIONAL LAYERS OF IRB REVIEW, OR CERTAIN OTHER REQUIREMENTS, ENGAGEMENT WITH THE COMMUNITY AND ADVISORY BOARDS. HERE WE'RE TAKING THE DATA OUT OF AN NIH REPOSITORY AND THINKING OF ALTERNATIVE STRUCTURES, MAYBE A NAVAJO BASED FACILITY FOR DATA AS WAS MENTIONED EARLIER, MAYBE THAT'S WHAT WOULD FIT UNDER HERE. SO THE EXAMPLES THAT I CAN SHARE HAVE TO DO WITH RESEARCH ON TYPE 2 DIABETES AND NON-COMMUNICABLE DISEASE, IN COMMUNITIES IN SUB-SAHARAN AFRICA. A RESEARCHER CAME TO THE INSTITUTE WITH A HISTORY OF HAVING ENGAGED WITH THESE COMMUNITIES AND WORKED WITH THEM SETTING UP CONSENT PROCESSES THAT ASSURED THEM THAT HE WOULD BE THE ONE INVOLVED IN DOWNSTREAM RESEARCH WITH THEIR SAMPLES. WE'VE APPROVED TWO ALTERNATIVE DATA SHARING PLANS WHERE HE'S VERY MUCH INVOLVED IN THE DECISIONS ABOUT WHO HE WILL COLLABORATE WITH TO ADVANCE THE WORK THAT IS SPECIFICALLY ON TYPE 2 DIABETES AND OTHER NON-COMMUNICABLE DISORDERS WHICH WERE IDENTIFIED AS PRIORITIES TO PURSUE. IN ONE CASE, HE HOUSES THE DATA IN HIS OWN LABORATORY OR HIS FACILITY, I ASSUME IT'S HERE ON CAMPUS, I SHOULD DOUBLE CHECK THAT DETAIL. IN THE OTHER CASE DATA ARE SHARED WITH CONSORTIUM THAT'S OVERSEAS NOT LOCATED AT THE NIH AND MADE UP WITH LOTS OF MEMBER RESEARCHERS AND PEOPLE INVOLVED, PARTICIPANTS IN THE RESEARCH, AND SO THEY HAVE DEVELOPED A SEPARATE MODEL AND SO I OFFER THAT AS ANOTHER EXAMPLE THAT EXISTS THAT WE'VE GOTTEN APPROVED AND SIGNED ON BY LEADERSHIP OF OUR INSTITUTION SO THIS IS POSSIBE. I THINK THE DISCUSSION WE NEED TO HAVE WHETHER THIS CAN WORK FOR TRIBAL RESEARCH. AND WHETHER IT WOULD FIT UNDER THE IDEA OF JUST 5*DING VERY ADDING CLEAR USE TO THE REPOSITORIES AT NIH. MAYBE THERE'S NO ONE COMMITTEE THAT CAN REPRESENT THE TRIBES AND OTHERS. WE CAN LOOKS AT DATA SHARING MODELS NEGOTIATED BETWEEN THE NIH AND TRIBAL COMMUNITIES THAT WOULD WORK FOR THEM TO STEWARD VERY IMPORTANT RESEARCH TAKING FORWARD. I KNOW THAT THERE ARE A NUMBER -- WE'LL HEAR BETWEEN TODAY AND TOMORROW ABOUT A NUMBER OF POTENTIAL CASE EXAMPLES. I KNOW THAT IN MY OWN INSTITUTE IN THE GENOME INSTITUTE, THERE IS AN OPENNESS TO DOING THIS AS WELL. I HEARD THAT AS RECENTLY AS FRIDAY FROM THE DIRECTOR OF MY POLICY BRANCH. WE HOPE TO DEMONSTRATE THERE ARE POSSIBILITIES WE CAN WORK WITH. SO BACK TO MY ORIGINAL -- THAT'S THE ANSWER. YES, BUT IT'S GOING TO DEPEND ON THE DETAILS. WHY DON'T WE OPEN IT UP AND SEE WHAT YOU HAVE TO THINK ABOUT OUR COMMENTS THIS AFTERNOON. THANKS. [APPLAUSE] >> QUESTIONS? >> EARLIER I HAD ASKED A QUESTION ON THE CLINICAL TRIALS, OF WHETHER OR NOT LIKE IF YOU'RE GETTING FUNDED BY NIH WHICH WOULD BE REQUIRED OR I ASSUME YOU WOULD BE REQUIRED TO SHARE DATA WITH NIH, BUT YOU ALSO HAVE THE WAIVER QUESTION. I WANTED TO FIND OUT IF DATA UNDER A GRANT THAT'S TRIBAL, THAT WILL GET EXCEPTION TO THE RULE, AND HOW. >> MAY I CLARIFY I THINK WHAT YOU'RE TALKING ABOUT, YOU SET THE clinicaltrials.gov REGISTRATION AND REPORTING REQUIREMENTS, RIGHT? NOT THE GENOMIC DATA SHARING POLICY? IS THAT CORRECT? IS THAT WHAT YOU'RE -- >> THAT'S PART OF IT AND THEN ALSO THE QUESTION THAT SAYS WHAT ARE THE PROCEDURES FOR REQUESTING AND OBTAINING A WAIVER OF THE REQUIREMENT. I WAS WONDERING IF WHEN IT COMES TO TRIBAL DATA AND A WAIVER IS REQUESTED WOULD THAT FALL UNDER 3, WHICH IS EXTRAORDINARY CIRCUMSTANCES? AND WHY GRANTING THE REQUEST WOULD BE CONSISTENT WITH PUBLIC HEALTH AND NATIONAL SECURITY? >> I'M GOING TO ADDRESS THE REQUIREMENT FOR RESULT SUBMISSION FOR THE clinicaltrials.gov FOR CLINICAL TRIALS AT THIS POINT AND I WILL EXPAND FROM THERE. JUST ONE THING TO HIGHLIGHT THAT REQUIREMENT FOR SUBMISSION FOR RESULT OF CLINICAL TRIALS IS FOR SUMMARY RESULTS, NOT INDIVIDUAL LEVEL DATA. SO JUST SUMMARY RESULTS REQUIRED TO BE SUBMITTED. AND THAT TO MAKE SURE DATA IS AVAILABLE TO THE COMMUNITY THEY WILL NOT REPLICATE SOMETHIG THAT'S BAD STRATEGY AND TO MAKE SURE DATA IS AVAILABLE FOR THE COMMUNITY TO REANALYZE. THERE IS MULTIPLE BENEFITS TO THAT. AND YES THERE IS A WAIVER MECHANISM TO WAIVE THE REQUIREMENT FOR RESULT SUBMISSION FOR CLINICAL TRIALS AND A MECHANISM FOR APPEAL AS WELL SO IN CASE THE WAIVER WAS REJECTED THERE'S A MECHANISM FOR APPEAL FOR THAT. AND THAT'S WHEN IT COMES TO -- I'M REALLY SO HOPEFUL THAT THROUGH DISCUSSION WITH ALL OF YOU WE CAN DISCUSS THE BENEFITS OF THIS DATA AND THE REASON FOR THIS DATA TO BE SHARED AND HOW THAT WILL BENEFIT THE COMMUNITY. IN A MANNER THAT'S RESPECTFUL TO THE SOVEREIGNTY OF TRIBE AND TO THE LAWS AS WELL. SO I'M A LITTLE BIT ANXIOUS FROM A SCIENCE POINT OF VIEW I FEEL THE DATA FOR THE BENEFIT OF EVERYBODY SHOULD BE SHARED. A LOT OF DATA YOU HAVE TO COMPARE POPULATIONS TO UNDERSTAND WHO IS AT RISK AND I THINK THAT'S REALLY IMPORTANT. I'M REMINDED OF A CLINICAL TRIAL AT HOPKINS, FOR EXAMPLE, WHERE SADLY THEY HAVE ONE SPECIFIC ETHNIC BACKGROUND REPRESENTED AND THEY FOUND OUT LATER, ASTHMA CONTROL TRIALS, THAT AFRICAN-AMERICANS AND PUERTO RICANS, FOR EXAMPLE, ARE NOT AS RESPONSIVE TO THE DRUG THEY THOUGHT WAS EFFECTIVE. STUFF LIKE THIS WORRIES ME. I LOSE SLEEP OVER THAT AND I'M HOPEFUL WE CAN WORK TOGETHER DATA CAN BE SHARED IN A RESPONSIBLE AND RESPECTFUL MANNER. DO YOU WANT TO ADD ANYTHING TO THAT? I'M SEE JODY IN THE BACK. DO YOU WANT TO ADD ANYTHING, JODY? >> (INAUDIBLE) >> OKAY. >> WELL, LET ME -- I'M GOING TO LEAVE MY SEAT AND GIVE IT TO TISHA SOLOMON. I THINK I KNOW WHAT I'M ASKING BUT SHE'S MORE THE TECHNICAL PERSON. >> JODY, YOU'RE A VOICE IN THE DARKNESS. COME UP TO THE TODAY. DR. JODY BLACK, DEPUTY DIRECTOR OF OFFICE OF EXTRAMURAL RESEARCH, SHE WILL CONTINUE IF NEEDED OR THERE'S AN OPPORTUNITY. >> SO IT'S A LITTLE UNFAIR TO YOU GUYS BECAUSE EVERYBODY ELSE HEARD ME ASK THIS QUESTION IN A PREVIOUS MEETING SO THEY ARE AHEAD OF US. WE HAVE A CASE RIGHT NOW, WHERE WE BRING UP THIS QUESTION AT THE UNIVERSITY OF ARIZONA, WE HAVE A STUDY THAT WAS ACTUALLY ON THE -- THAT IS, IT'S AN ACTIVE STUDY, THAT'S ON THE NAVAJO NATION. THERE ARE TWO ELEMENTS FOR THIS QUESTION. IT IS AN INTERVENTION STUDY, IT IS AN EXERCISE INTERVENTION STUDY, AND WHEN THE TEAMS DID THE WORK THAT'S REQUIRED ON THE NAVAJO NATION TO RECEIVE PERMISSION TO MOVE THE STUDY FORWARD, WHICH TOOK ABOUT A YEAR, THEY DIDN'T CALL IT A CLINICAL TRIAL BECAUSE AT THAT TIME IT'S AN INTERVENTION STUDY, IT WASN'T A CLINICAL TRIAL. IN THE TIME PERIOD SINCE THEN, THE DEFINITION HAS MODIFIED, AND I KIND OF GET THE FEELING IT'S STILL UNCLEAR BECAUSE THE READ THE NIH BLOG TODAY THAT SAID STILL FUZZY, THAT PRESENTS AN ISSUE FOR THE RESEARCHERS BECAUSE THE OFFICE OF SPONSORED PROJECTS AT THE UNIVERSITY IS RESPONDING TO WHAT THEY SEE ON PAPER, AND THAT'S A WHOLE OTHER BUREAUCRACY, THEY SAY YOU HAVE TO REGISTER AT A CLINICAL TRIAL. ONE ARM DID IT BUT WHAT HAPPENS WHEN THAT OCCURS IS THAT THE AGREEMENT WITH THE NATION WAS THAT INFORMATION WOULD NOT BE SHARED. SO THE PROCESS REQUIRING THIS NEW KIND OF RULING REQUIRES THEM TO HAVE TO GO BACK, AND IT CAUSES SOME PROBLEMS. SO THAT'S THE BIG ISSUE. I THINK THIS IS RELEVANT TO SOME OTHER THINGS YOU'VE BEEN SAYING IN TERMS OF WAIVERS OR EXCEPTIONS THAT THE ISSUE IS OCCURRING IN THE POST. SO YOU'RE ALLOWING PEOPLE TO REQUEST AN EXCEPTION. WELL, THAT'S HAPPENED AFTER THE FACT BECAUSE ALL OF THE WORK THAT'S BEING DONE TO WORK WITH THE COMMUNITIES UP FRONT IS DONE PRIOR TO. AGREEMENTS ARE PUT IN PLACE PRIOR TO. ANY POLICY OR KNOWLEDGE THAT COULD BE HELPFUL BEFORE WE GO FORWARD SO WE DON'T END UP IN THE SITUATION WHERE WE HAVE TO ASK PERMISSION TO POST, WE DON'T KNOW IF WE'RE GOING TO GET IT OR NOT. IS THAT BETTER? CLEARER? >> THAT'S ACTUALLY VERY HELPFUL. DO YOU WANT TO ADD SOMETHING TO THAT? >> THERE'S A PROBLEM WITH -- (INAUDIBLE) 9 GOAL IS TO FIGURE OUT HOW TO MAKE EVERYBODY COMFORTABLE. YOU'RE CONCERNED ABOUT GOING FORWARD, HOW THE NEGOTIATIONS WILL WORK, IF THE GOAL IS TO FIRST ENSURE THAT THE NATIONS UNDERSTAND THE RESULTS OF THEIR TRIAL BEFORE THE ENTIRE COMMUNITY DOES. >> I DON'T KNOW IF YOU WERE HERE EARLIER. >> I CAME IN 20 MINUTES AGO. >> IF I MAY USE THE NAVAJO NATION AS AN EXAMPLE. I HAVE CANDY. >> I WAS IN ARIZONA FOR FOUR YEARS AT T-GEN. >> NO, THAT DOESN'T MAKE ME MORE COMFORTABLE. >> I DID HAVE A LOT OF CONVERSATION ABOUT HOW TO DO THIS PROPERLY. >> FOR EVERYBODY'S KIND OF EXPERIENCE, THE PROCESS OF COMMUNITY ENGAGEMENT THAT'S REQUIRED, AND EACH TRIBE IS DIFFERENT, EACH PROCESS IS DIFFERENT, ACTUALLY SOME GILA RIVER PEOPLE IN THE PAST HAD A POLICY WHERE YOU HAVE TO GO THROUGH APPROVAL WITH THE TRIBAL COUNCIL BEFORE YOU EVEN TALK TO ANYONE ELSE. SO EVERYBODY HAS A DIFFERENT WAY OF DOING IT. IN THIS PARTICULAR EXAMPLE, BEFORE I PRESENT, LIKE I AM RIGHT NOW, I HAVE TO ASK PERMISSION. >> RIGHT. >> TO EVEN TALK ABOUT THIS, WHICH I DID. BECAUSE I WASN'T GOING TO MENTION THE NATION BUT BECAUSE SHE WAS HERE I ASKED PERMISSION TO DO THAT. SO EVERYTHING WE DO, THE POSTERS, PRESENTATIONS, THE PAPERS, TO TURN IN REPORTS WE ASK PERMISSION PRIOR TO. I KNOW POLICIES CHANGE. I KNOW HOW CHALLENGING IT IS TO PUT IN PLACE. IF POLICY IS ADDRESSED UP FRONT SPECIFIC TO TRIBAL NATIONS AND WHAT THEIR NEEDS ARE IN A GENERAL SCOPE, SO HERE ARE THE RULES, IF THE TRIBE WANTS THAT INFORMATION SHARED THAT'S IN THE AGREEMENT WITH THE INDIVIDUAL COMMUNITY AND THE RESEARCHER. YES, THIS ASTHMA INFORMATION IS IMPORTANT AND WE WANT THE WORLD TO KNOW ABOUT IT. THAT SHOULD BE THE DISCUSSION THEY HAVE AND PUT IN PLACE FIRST. AS RESEARCHERS WE'RE THINKING ABOUT -- WE KNOW SHARING IS GOOD BUT THINK ABOUT THINGS AS DR. BEGAY TOLD US FROM A DIFFERENT MIND SET. ON THE OTHER SIDE OF THE WORLD YOU'RE SAYING YES, BUT WHAT ARE THE PROBLEMS WHEN I SHARE THIS DATA, NOT WITH JUST THE INDIVIDUAL BUT WITH THE COMMUNITY. BECAUSE WE'VE HAD A LOT OF EXPERIENCES IN THAT, WE KNOW WHAT HAPPENS. >> >> OKAY. >> DOES THAT MAKE MORE SENSE? >> IT MAKES A LOT OF SENSE. THERE NEEDS TOCK A -- TO BE A CLEAR UNDERSTANDING OF THE VALUE OF THE INFORMATION FOR BOTH SIZE, WHAT'S REQUIRED IN THE REGISTRATION PROCESS. WHAT I DON'T KNOW IS WHAT KIND OF CONVERSATIONS YOU'VE HAD ABOUT THAT PARTICULAR INFORMATION. AND WHAT THE THOUGHTS ARE ABOUT CONTRIBUTING TO THAT DATABASE. >> I JUST LEARNED ABOUT IT LIKE LAST WEEK. >> OKAY. >> I'M NOT -- I THINK IT WAS RELATIVELY NEW TO THEM AS WELL. IN THIS PARTICULAR CASE, THAT'S THE SITUATION. >> RIGHT. >> BUT I'M SUGGESTING THAT EVERY POLICY HAVE THIS KIND OF THOUGHTS ABOUT IT, IT'S OKAY TO HAVE THESE, WELL, HERE DO THIS AND IF YOU HAVE A PROBLEM CALL ME BECAUSE ME MAY NOT BE GOOD HARDED LOVABLE WONDERFUL DAVE WILSON IN FIVE YEARS, IT MAY BE SOMEBODY ELSE. WHEN WE PUT POLICIES IN PLACE BE THOUGHTFUL WHAT ARE WE TRYING TO ACCOMPLISH AND ARE WE DOING THAT BY SAYING, WELL, JUST PUT AN EXCEPTION IN FOR THAT. >> THAT'S ACTUALLY A POINT WELL TAKEN. I THINK WE SHOULD THINK ABOUT THAT, HOW TO INCORPORATE THAT SO EARLIER STAGE, YOU KNOW, I FEEL LIKE WE'RE SLOWLY DOING THAT BETTER, REALIZING THE NEED TO INTERACT WITH THE COMMUNITIES, DOING THAT THROUGH THRO AND DIFFERENT INTERACTIONS. THAT SAID, AND ANY POLICY, ANY NEW POLICY, IT WILL BE A PERIOD OF ADJUSTMENT. I'M SURE LIKE WE'VE BEEN WORKING WITH OER, THEY HAVE AN AMAZING TEAM WORKING DAY AND NIGHT LITERALLY TO MAKE SURE FAQS AND WEBSITES ARE OUT, THE COMMUNITY UNDERSTAND WHAT IS WE'RE TRYING TO MEAN, WE'RE GOING TO MISS STEPS AND HOPEFULLY WE'LL PROVE OVERTIME. THANK YOU. WE NEED SOMETHING LIKE YOU TO TELL US. THIS IS SOMETHING IN OUR MINDS. >> WE HAVE CHIEF AND MALIA AND WE'LL WRAP UP. >> I THINK WE SHOULD ALWAYS BE THINKING ABOUT IN RESEARCH, THERE'S NOT A LOT OF HOMOGENEITY AMONG INDIAN TRIBES AND ALASKA NATIVES. ONE THING ABOUT SHARING DATA, IS THIS ISSUE SPECIFIC TO A PARTICULAR COMMUNITY OR IS THE DATA REALLY VALUABLE TO EVERYONE AT LARGE, RIGHT? BECAUSE IF YOU TALK TO VARIOUS TRIBAL LEADERS THEY WILL TELL YOU A LOT OF OUR PROBLEMS STEM FROM THE FACT THAT THERE'S A SUPERFUND SITE ON OUR RESERVATION THAT CREATED A SPECIFIC HEALTH ISSUE THAT PROBABLY CHANGED THEIR EPIGENETICS SOMEWHAT, I'M NOT A RESEARCHER SO I'M TALKING OUT OF MY HAT A LITTLE BIT. SO THE QUESTION IS, YOU KNOW, IS IT REALLY APPLICABLE TO A PARTICULAR COMMUNITY OR IS THE DATA SO COMPELLING AND WIDESPREAD FOR MULTIPLE COMMUNITIES THAT IT NEEDS TO BE SHARED? THAT'S SOMETHING WE SHOULD BE THINKING ABOUT. AND I THINK WE HAVE TO THINK ABOUT SAMPLE SIZES TOO BECAUSE THERE ARE SOME TRIBAL COMMUNITIES THAT ARE VERY TINY, AND I THINK ABOUT CALIFORNIA A LITTLE BIT, WITH SOME OF THE VERY SMALL AND SOME OF THE PUEBLOS ARE VERY SMALL SO IF YOU'RE DOING RESEARCH THERE YOU'RE GOING TO KNOW WHO THAT COMMUNITY IS, RIGHT? SO IT HAS TOO TO GO BACK TO THE COMMUNITY, ARE WE WILLING TO SHARE THIS INFORMATION? PART BEGINS WITH THE CONSENT PROCESS, THE WAY THE STUDY IS DESIGNED, AND MY OTHER QUESTION IS, IS THERE A REQUIREMENT THAT BEFORE THERE'S ANY PUBLICATION OF THE RESULTS, THAT THE TRIBE IS CONSULTED, AND THAT THE TRIBE HAS THE CHANCE TO REVIEW IT. AND THEY FEEL THEIR INFORMATION IS BEING SHARED IN A WAY THEY THINK IS ACCEPTABLE. THAT'S MORE OF A COMMENT I GUESS. >> MA LEAH AND WE'LL TRY TO GET YOU IN, BOBBY. >> I THINK THERE WAS A SUGGESTION MADE ABOUT PROCESS WHERE TRIBES COULD SELF IDENTIFY THEIR PREFERENCE, AND I KNOW THAT 27 INSTITUTES AND CENTERS IS A LOT, 567 FEDERALLY RECOGNIZED TRIBES IS A LOT. THERE'S A WILLINGNESS TO WANT TO LOOK AT THAT BECAUSE I THINK THE CONVERSATION THAT I HEARD DOWN HERE WAS ABOUT A QUESTION RELATED TO INVESTIGATOR INITIATED EXCEPTIONS THAT THAT MAY BE NECESSARY BUT NOT SUFFICIENT FOR LOOKING AT HOW THESE PROTECTIONS AND BENEFITS ARE BEING REALIZED FOR RESEARCH. WHAT I REALLY LIKED ABOUT WHAT YOU'RE SAYING IS A LOT, DR. HULL IN PARTICULAR, BECAUSE I CAME IN LATE, I APOLOGIZE, IS THE DECISION-MAKING CASE STUDIES. IT SOUNDS LIKE YOU'RE WORKING WITH THE COORDINATING COMMITTEE TO TALK ABOUT HOW INSTITUTES AND CENTERS ARE MAKING DECISIONS IN THESE CASES, THAT COULD BE A RICH VALUE THERE. AND THE OTHER THING I'M TAKING AWAY FROM THIS CONVERSATION IS THAT WE'VE BEEN TALKING ABOUT DATA SHARIN. THERE'S TWO SIDES OF THE COIN WHICH IS DATA SHARING AND DATA USE. SO IT'S ONE QUESTION TO LOOK AT ARE WE GIVING PERMISSION TO SHARE THE DATA INTO A REPOSITORY, BUT THE OTHER PIECE WHICH I THINK THERE'S GREAT PROTOCOLS, I'LL POINT TO MY SISTER FROM ALASKA, IS IT BROADLY APPLICABLE ON THAT FRONT OR NOT. ONE LAST COMMENT, BELMONT HAS BEEN BROUGHT UP SEVERAL TIMES TODAY AND IT'S IMPORTANT, OUR READ, WHEN I WAS AT NCI, MY READ OF BELMONT, BELMONT WAS INITIATED BECAUSE OF VIOLATIONS AGAINST WHOLE COMMUNITIES. IT WASN'T NECESSARILY INITIATED BECAUSE OF VIOLATIONS AGAINST INDIVIDUALS. IT WAS GROUPS OF PREGNANT MOTHERS, GROUPS OF PRISONERS, CHILDREN, POPULATIONS, AND SO THINKING ABOUT THE MISSION AND THE SPIRIT OF BELMONT IS SO MUCH IN LINE WITH WHAT WE'RE HERE TO DO WHICH IS COMMUNITY PROTECTION. SO JUST TO KIND OF BE SURE TO RAISE THAT IN THE CONVERSATION HERE. >> THANK YOU. WE RECENTLY HAD A RESEARCH PARTNER WHO SUBMITTED TO A PUBLICATION AND THE PUBLICATION IS REQUIRING THEM TO SUBMIT DATA BEFORE THEY WILL CONSIDER IT. THEY ARE WANTING DATA, PRE-ANALYSIS DATA, THEY WANT RAW DATA. IS THAT CONSISTENT WITH THE NIH POLICY OR IS THAT SOMETHING THAT'S OVERSTEPPING THE NIH POLICY AND YOU THINK IS DIRECTLY MORE RELATED TO THE PUBLIC -- TO THE JOURNAL? >> A GREAT QUESTION. I HAVE BEEN HEARING FROM INVESTIGATORS TOO THAT THE JOURNAL SEEMS -- I DON'T KNOW FANTASTIC RIGHT TO - IF IT'S RIGHT TO SAY THEY ARE OVERSTEPPING BUT WORKING AHEAD TO PROMOTE CULTURE SHARING AND OPENNESS IN A WAY THAT DOESN'T NECESSARILY FOLLOW WITH THE INFRASTRUCTURE THAT WE'RE -- OR THE CAREFUL POLICY REVIEW. WE'VE HAD A COUPLE INVESTIGATORS WHO HAVE EXCEPTIONS WHO I THINK AND I'M LOOKING TO DR. LAURA RODRIGUEZ BECAUSE SHE MAY KNOW. SHE'S THE DIRECTOR OF OUR POLICY OFFICE. HAVE OUR INVESTIGATORS WHO HAVE EXCEPTIONS CERTIFIED BEEN ABLE TO SHARE CERTIFICATIONS AS EVIDENCE TO JOURNALS THEY ARE FOLLOWING THE POLE -- POLICY AND THERE NEEDS TO BE EXCEPTIONS? DO YOU KNOW IF JOURNALS ARE TENDING TO ACCEPT THAT AS VALID EXCUSE OR ARGUMENT? IT'S SOMETHING WE NEED TO REVISIT. >> I DON'T KNOW. I HAVEN'T HEARD FROM INVESTIGATORS GRANTED AN EXCEPTION TO SAY NOW I CAN'T PUBLISH MY PAPER, I'M ASSUMING THEY HAVE BECAUSE EXCEPTIONS HAVE BEEN IN PLACE FOR A WHILE BUT DON'T HAVE CONCRETE EVIDENCE. IT'S AN INTERESTING IDEA. I HOPE IT WILL, AND I AND OTHERS WOULD SPEAK TO THE JOURNALS BECAUSE THEIR EXCEPTIONS BRING THEM IN COMPLIANCE WITH OUR POLICY. >> WE'VE HAD TO DO A COUPLE ETHICS CONSULTS AND WRITE UP A REPORT AND SEND THAT TO THE EDITOR TO EXPLAIN THAT THERE'S REALLY IMPORTANT ALTERNATIVE JUSTIFICATION, ETHICAL JUSTIFICATION HERE FOR A PARTICULAR PRACTICE THAT THEY SHOULD ACCEPT AND UNDERSTAND AND I THINK IN A COUPLE OF SPECIFIC DIFFICULT TO DISCUSS CASES THAT'S WORKED BUT THE REQUIRES A REALLY ROBUST RESEARCH ETHICS SUPPORT INFRASTRUCTURE AND ABILITY TOED ADVOCATE. IT'S AN AREA WE NEED TO PAY MORE ATTENTION TO. >> THE INSTITUTIONAL CERTIFICATION, DOES THAT HAVE TO BE IN PLACE WHEN YOU REQUEST THE EXCEPTIONS? I NEVER HEARD OF IT UNTIL THIS WEEK, THE SAME RESEARCHER I'M TALKING ABOUT WHO IS WISHING TO PUBLISH NEVER HEARD OF IT EITHER. THEIR OFFICE OF RESEARCH ADMINISTRATION HAD NEVER HEARD OF IT. SO THESE ARE NOT IN PLACE THAT I KNOW OF IN ANY OF OUR PROJECTS. >> THESE ARE SPECIFIC TO THE GENOMIC DATA SHARING POLICIES. >> RIGHT. >> SO THIS IS FOR NIH-FUNDED GENERATION CONSEQUENCING, AND RESEARCH THAT FALLS UNDER THAT POLICY, THAT'S A SPECIFIC DOCUMENT THAT IS RELATED TO KIND OF BEING IN COMPLIANCE WITH THAT POLICY, THE INSTITUTIONAL CERTIFICATION, THERE'S DIFFERENT TIME LINES FOR INTRAMURAL AND EXTRAMURAL BUT THAT'S SOMETHING THAT THE INSTITUTION HAS TO SIGN OFF ON, THE INSTITUTION WHERE THE DATA ARE BEING GENERATED BEFORE THE DATA CAN BE DEPOSITED IN AN NIH REPOSITORY. SO THAT'S VERY SPECIFIC TO THAT POLICY, AND I GUESS I DON'T KNOW ABOUT VARIABILITY IN TERMS OF HOW AND WHERE IT'S BEING USED ACROSS DIFFERENT RESEARCH PROJECTS. >> THANK YOU. >> ALL RIGHT. WALTER, WE'RE RUNNING A LITTLE BIT BEHIND. WE NEED TO REALLY WRAP IT UP. OKAY? BECAUSE WE'RE IN CAUCUS TIME AND WE STILL HAVE TO TAKE A PICTURE. >> PRIORITIES. >> THANK YOU VERY MUCH. I THINK MISS HULL RAISED SOME QUESTIONS IN HER PRESENTATION UNDER THE DATA USE LIMITATIONS AND ALTERNATIVE DATA SHARING ON HER ONE BULLET POINT, AND I WAS THINKING THAT MAYBE, YOU KNOW, THE COMMITTEE HERE COULD PUT THOSE ITEMS ON AN AGENDA SEPARATELY AND SPEND A LITTLE MORE TIME TO SORT OF GIVE HER SOME GUIDANCE ALONG THOSE LINES. SO I JUST THOUGHT I'D MAKE THAT RECOMMENDATION. >> THINK YOU. WELL, IN CLOSING, I'LL PULL RANK HERE. NO, JUST TEASING. [LAUGHTER] THAT QUESTION THAT WAS ASKED WITH THE DECLARATION, A LOT OF OUR YOUNG SCHOLARS WHO ARE DOING RESEARCH AND WANTING TO PURSUE THEIR DOCTORATE DEGREES COME TO ME AND ASK ME COULD I CHAIR -- FORMER CHAIRMAN OF THE REGIONAL IRB FOR WYOMING TRIBES, WHAT ABOUT NATIVE EPISTOMOLOGY, HOW DOES THAT PLAY INTO THE FIELD NOW WITH ACADEMICS? THEY KNOW THEY DRINK THE KOOL-AID AND HAVE TO MEET THOSE STANDARDS, BUT AT THE SAME TIME SOME OF THAT IS CONTRADICTORY TO OUR WAYS OF KNOWING, OUR WAYS OF LEARNING. SO I THOUGHT I'D SAY THAT, THAT QUESTION THAT YOU ANSWERED ON YOUR PRESENTATION, STILL NEEDS SOME CLARITY FROM THE TRIBAL PERSPECTIVE. BUT THANK YOU GUYS. HOW ABOUT A ROUND OF APPLAUSE. [APPLAUSE] >> : NEXT UP BOBBY SAUNKEAH, CHICKASAW NATION, CERTIFIED DIABETES EDUCATOR AROUND MANAGER OF THE RESEARCH AND PUBLIC HEALTH DEPARTMENT. MR.SAUNKEAH HAS SERVED ON THE CHICKASAW NATION IRB FOR MANY YEARS AND IS CHAIR AS WELL AS HUMAN RESEARCH SUBJECT PROTECTION ADMINISTRATOR, INDIAN HEALTH SERVICE IRB, AND OU COLLEGE OF PUBLIC HEALTH. WE'LL HAVE MICHAEL PEERCY, ADVISORY MEMBER TO THE SOUTHERN PLAINS TRIBAL EPIDEMIOLOGY CENTER, NATIONAL MEMBER AT LARGE AMERICAN INDIAN/ALASKA NATIVE HEALTH RESEARCH ADVISORY COMMITTEE AND ADVISORY MEMBER TO THE CHOCTAW NATION IRB, FORMERLY LIAISON TO NARCH OKLAHOMA, WITH A WONDERFULLY CON CONDENSED VERSION. . >> THANKS FOR HAVING US. WE'LL GO OVER THE IRB PROGRAM IN THE CHICKASAW NATION. WE APPRECIATE THE OPPORTUNITY TO PRESENT. MICHAEL AND I DO THESE KINDS OF PRESENTATIONS FAIRLY FREQUENTLY, AND GENERALLY WE START WITH A LITTLE INTRODUCTION TO THE NATIVE EXPERIENCE IN OKLAHOMA BECAUSE A LOT OF PEOPLE ARE NOT FAMILIAR WITH IT. SO WE'D LIKE TO LET YOU KNOW A LITTLE BIT ABOUT WHAT THE INDIAN EXPERIENCE IS IN OKLAHOMA SO YOU CAN HAVE CONTEXT. WE IS THE SECOND LARGEST POPULATION OF AMERICAN INDIANS IN THE UNITED STATES, SECOND TO ONLY CALIFORNIA. AND WE HAVE QUITE A FEW FEDERALLY RECOGNIZED TRIBES AS WELL AS TRIBES NOT RECOGNIZED BY THE FEDERAL GOVERNMENT AS WELL. AND THERE ARE 25 NATIVE LANGUAGES THAT ARE SPOKEN IN OKLAHOMA, SO WE SERVE A MICROCOSM IN MANY WAYS AND WE HAVE A LOT OF INDIANS CONDENSED IN A VERY SMALL AREA. EACH OF THE OKLAHOMA TRIBES IS UNIQUE, WE HAVE OUR OWN CULTURE AND HISTORY, I'M KIAWAH BUT I WORKED FOR THE CHICKASAW NATION 20 YEARS, A LOT OF SIMILARITIES AND DIFFERENCES IN OKLAHOMA JUST AS IN YOUR PART OF THE COUNTRY AS WELL. AGAIN, MOST OF THEM HAVE SOVEREIGN NATION STATUS. ONE OF THE THINGS THAT'S IMPORTANT TO REMEMBER ABOUT OKLAHOMA IS WE ARE A NON-RESERVATION-BASED STATE SO THERE'S ONLY ONE NATIVE RESERVATION IN OKLAHOMA, THE OSAGE RESERVATION. ALMOST HALF OF AMERICAN INDIANS IN OKLAHOMA LIVE IN URBAN AREAS, AND WE LIVE JUST INTERSPERSED AMONG THE GENERAL POPULATION. WE DON'T HAVE RESERVATIONS. WE HAVE TERRITORIAL JURISDICTIONS, SO THIS IS JUST A MAP THAT SHOWS YOU THE AMERICAN INDIAN TERRITORIAL JURISDICTIONS IN OKLAHOMA, AND YOU SEE THE CHICKASAW NATION IN THE SOUTH CENTRAL AREA, ONE OF THE LARGER ONES, AND OUR NEIGHBORS CHOCTAW AND CHEROKEE IN THE NORTHEASTERN PART. IN THE WEST THERE'S HARDLY ANY INDIANS AT ALL. WE HAVE GEOGRAPHIC JURISDICTIONS THAT DEFINE OUR TERRITORIES. THE REASON WE HAVE SUCH A DIVERSITY OF TRIBES AND CULTURES AND HERITAGE IN OKLAHOMA IS BECAUSE WE WERE REMOVED FROM OUR HOMELANDS IN OTHER PLACES, IN OTHER PARTS OF THE COUNTRY SO YOU MAY RECOGNIZE SOME OF YOUR OWN TRIBES, TRIBES IN YOUR NECK OF THE WOODS, THAT WERE RELOCATED TO OKLAHOMA BACK DURING THE REMOVAL. AND SO IT EXPLAINS REALLY THE DIVERSITY IN OKLAHOMA. AND SO I THINK THAT KIND OF HELPS GIVE A LITTLE BIT OF CONTEXT ON THE EXPERIENCE THERE. THE CHICKASAW NATION, WE'RE 13 COUNTIES IN RURAL SOUTH CENTRAL OKLAHOMA, AND THE WHOLE AREA, 13-COUNTY AREA, THERE'S ABOUT 350,000 RESIDENTS, 10% OF THOSE ARE NATIVE AMERICANS. THESE ARE JUST SOME OF THE HEALTH FACILITIES, THE GOVERNOR SINCE THE MID-'80s, PRETTY AMAZING WHEN YOU THINK ABOUT IT, THAT PROBABLY HASN'T HAPPENED IN MOST TRIBES, COMMITTED TO HEALTH AND RESEARCH, AND SO THAT CONTINUITY AND THAT TYPE OF COMMITMENT HAVE MADE AN IMPACT ON OUR HEALTH. THESE ARE SOME HEALTH FACILITIES IN THE CHICKASAW NATION, EXCEPT FOR THE ONE ON THE BOTTOM RIGHT-HAND CORNER. THAT'S OUR CULTURAL CENTER IN SULFUR, OKLAHOMA. SO I KNOW I DON'T NEED TO TELL Y'ALL THE ROLE OF THE TRIBAL IRBS, BUT BASICALLY WE HAVE THE INTERESTS OF THE TRIBE, THE COMMUNITY, AT HEART. OUR JOB IS TO PROTECT THE CULTURE AND HERITAGE OF THE TRIBE, AS WELL AS OUR INDIVIDUAL RESEARCH PARTICIPANTS, AND WE DO THAT TO PERPETUATE OUR SOVEREIGNTY RIGHTS. WE'VE HAD AN IRB SINCE 1998, AGAIN EXECUTIVE ORDER FROM GOVERNOR BILL ANOATUBBY ESTABLISHED OUR IRB, AND WE HAD THE LEGISLATURE HAVE A HEALTH RESEARCH ACT IN THE SAME YEAR. VERY EARLY ON WE WERE VERY HEAVILY SCIENTIFIC. WE HAD QUARTERLY MEETINGS. WE DIDN'T MEET THAT OFTEN. AND THIS CAME ABOUT BECAUSE WE HAD -- WE STARTED PARTICIPATING IN RESEARCH BASICALLY, SOME OF YOU MAY BE FAMILIAR WITH THE 10 TRIBES ALCOHOLISM STUDY AND THEN THE VERY SHORT-LIVED PARKE-DAVIS DIABETES MEDICINE WHICH DIDN'T LAST LONG AND HAS SIGNIFICANT SIDE EFFECTS. WE STARTED GETTING INVOLVES IN RESEARCH ACTIVITIES AND SO WE FELT LIKE WE WANTED TO DIRECT AND MONITOR THE RESEARCH OURSELVES AND SO WE ESTABLISHED THE TRIBAL IRB, THE IRB IS LOCATED WITHIN OUR DEPARTMENT, ACTUALLY OUR DEPARTMENT OF RESEARCH AND POPULATION HEALTH, WITHIN THE DEPARTMENT OF HEALTH FOR THE CHICKASAW NATION. I'M THE CHAIR; MICHAEL IS THE ADMINISTRATOR. AND AGAIN, OUR WHOLE HUMAN RESEARCH PROTECTION PROGRAM IS WITHIN OUR DEPARTMENT. AND WE ARE A FEDERALLY REGISTERED IRB SINCE ABOUT 2004. WE HAVE AN FWA FOR THE SAME AMOUNT OF TIME I GUESS. AND WE FOLLOW OHRP GUIDELINES AS WELL AS OUR OWN INTERNAL POLICIES, CHICKASAW NATION RESEARCH POLICIES. AND, AGAIN, OUR CHARGE IS TO PROTECT THE SAFETY OF OUR RESEARCH PARTICIPANTS AND GUARD THE INTEGRITY AND HERITAGE OF THE CHICKASAW NATION. THESE ARE JUST A FEW OF THE SELECTED PROJECTS THAT WE'VE BEEN INVOLVED IN, EITHER CURRENTLY OR RECENTLY. WE REVIEW A WIDE VARIETY OF RESEARCH PROJECTS FROM CLINICAL, EPIGENETIC, WE'VE HAD A LITTLE BIT OF GENETIC RESEARCH, WE'RE JUST KIND OF GETTING OUR FEET WET IN THAT ARENA. WE DO A LOT OF HEALTH DISPARITIES RESEARCH. WE HAD SOME CLIMATE CHANGE RESEARCH. YOU KNOW, JUST PREVENTION, SUBSTANCE ABUSE, PRE-ECLAMPSIA, WE DID A PRE-ECLAMPSIA STUDY FOR SOME TIME NOW, RECENTLY PARTNERED WITH DR. LYLE BEST AND HIS GROUP, SHARING ACTUALLY SOME OF OUR TISSUE SAMPLES WITH HIM SO THAT HE COULD CONTINUE SOME SIMILAR WORK IN HIS GROUP THAT HE'S BEEN DOING FOR A WHILE. OBVIOUSLY SOME DIABETES AND OBESITY PROJECTS. WE ALSO HAVE AN ELSI, ETHICAL LEGAL SOCIAL IMPLICATIONS GRANT WITH OUR PARTNERS AT THE UNIVERSITY OF OKLAHOMA, SOUTHCENTRAL FOUNDATION AND MISSOURI BREAKS. WE'VE GOT REPRESENTATIVES FROM OUR COLLABORATIVE PARTNERS AND WE'RE LOOKING AT DOING SOME PERCEPTIONS ON GENETIC RESEARCH IN OUR COMMUNITIES AND I THINK SOUTHCENTRAL FOUNDATION HAS DONE SOME OF THIS WORK SOME TIME AGO. WE'RE LAGGING A LITTLE BIT BIND IN DOING THE COMMUNITY PIECE OF IT, SO WE'RE THROUGH OUR WORK IN THIS ELSI GRANT WE'RE DEVELOPING SURVEYS AND COMING UP WITH DELIBERATIVE PROCESSES SO WE CAN GO OUT IN THE COMMUNITY AND INFORM THE COMMUNITY ON GENETIC RESEARCH AND PROS AND CONS AND HAVE TRUE DELIBERATION ON THAT WHAT MIGHT LOOK LIKE IN THE CHICKASAW NATION AS WELL AS OUR PARTNER COLLABORATORS. SO WE DON'T ONLY REVIEW HEALTH RESEARCH IN THE IRB, WE REVIEW ANY AND ALL RESEARCH. SO CULTURE RELATED, LANGUAGE, AS LONG AS IT'S GOT HUMAN LIVING SUBJECTS WE REVIEW IT. WE'VE DONE A WILD ONION RESEARCH PROJECT, AND SO ANYTHING THAT COMES THROUGH PRETTY MUCH WE REVIEW IT. AND I THINK BY NOW WE'VE BEEN DOING THIS FOR ABOUT 6 YEARS NOW, SPECIFICALLY OUR GROUP. I THINK PRETTY MUCH MOST OF THE CHICKASAW NATION NOW KNOWS IF THERE'S ANYTHING THAT SMELLS LIKE RESEARCH, THAT THEY PROBABLY OUGHT TO SEND IT OUR WAY FIRST, BECAUSE WE NEED TO TAKE A LOOK AT IT. IF IT IS, FINE. IF IT'S NOT, THAT'S ALSO FINE. THERE FOR A LONG TIME WE HAD A LOT OF DISSERTATION WORK AND THESIS WORK THAT PEOPLE DIDN'T REALLY CONSIDER RESEARCH, AND SO THEY DIDN'T -- IT WASN'T REALLY REVIEWED AND FOLLOWED VERY WELL. SO I THINK PRETTY WELL WE'VE GOT THAT IRONED OUT AND MOST OF THOSE PROJECTS COME TO US NOW. I'M GOING TO LET MICHAEL TALK ABOUT OUR POLICIES AS PART OF OUR PROTECTIONS PROGRAM. SORRY FOR GOING SO FAST BUT, YOU KNOW, I'M SCARED. [LAUGHTER] >> I'M MORE SCARED THAN BOBBY SO I'LL GO EVEN FASTER. WE FOR THE SECOND HALF OF THE PRESENTATION TOOK SOME EXCERPTS FROM OUR POLICIES AND FROM OUR RESEARCH AGREEMENT, TO KIND OF SHOW SOME OF THE PRINCIPLES THAT WE TALK ABOUT HERE AND SOME OF THE GUIDELINES AND PRINCIPLES THAT WE REALLY TRY TO ENFORCE AT THE CHICKASAW NATION. THE FIRST PARAGRAPH OF THIS IS IN ALL OF OUR POLICIES THAT THE CHICKASAW NATION HAS THE INHEARNS SOVEREIGN AUTHORITY TO GOFF EN-- GOVERN ITSELF AND PROVIDE FOR HEALTH AND WELL BEING OUR PEOPLE AND INDIAN PEOPLE WE SERVE. NOT RESERVATION BASED, WE SERVE ALL AMERICANS WITHIN OUR AREA AND HAVE A LARGE NUMBER OF TRIBES WITHIN THAT AREA. SO ONLY ABOUT HALF ARE CHICKASAW. THE REST ARE OTHER TRIBES. AND WE PRESCRIBE TO DO THIS ACCORDING TO THE HIGHEST STANDARDS OF ETHICS. AND WE ALSO PUT IN OUR POLICIES THAT WE VALUE THE RESEARCH AND WHAT RESEARCH CAN BRING TO THE TRIBE, WHAT IT DOES FOR US AND HOW IT CAN HELP SERVE OUR PEOPLE. OUR PARTICIPATION AND RESEARCH POLICY, WE TALK ABOUT OUR JURISDICTION. WE CAN ONLY GOVERN RESEARCH WITHIN THE CNDH, SERVICE AREA CHICKASAW NATION DEPARTMENT OF HEALTH IN THE ADA SERVICE AREA. ONCE BEYOND OUR TRIBAL JURISDICTION, WE FEEL WE DO NOT HAVE THE JURISDICTION TO -- THE AUTHORITY TO GOVERN THAT RESEARCH. WE WILL REVIEW THE MERIT OF ALL PROPOSED RESEARCH. AND DETERMINE WHETHER THE CHICKASAW NATION WILL PARTICIPATE. WE WILL FOLLOW OUR POLICIES, AND WE REFUSE TO PARTICIPATE IN RESEARCH THAT RESULTS IN THE DENIAL OF MEDICAL TREATMENT TO PATIENTS. THAT'S VERY IMPORTANT BECAUSE WE OFTEN RECEIVE PEOPLE WANTING TO DO RCTs, RANDOMIZED CLINICAL TRIALS, WHERE YOU HAVE THE ARM THAT RECEIVES THE TREATMENT AND THE SIDE THAT DOES NOT. SO WE FROWN ON RCTs. RELEASE AND DISSEMINATION OF RESULTS POLICY, ONE OF OUR MORE CONTROVERSIAL POLICIES I WOULD SAY. WE REVIEW AND APPROVE OR DISAPPROVE ALL PUBLICATIONS AND PRESENTATIONS PRIOR TO DISSEMINATION. NO MATTER WHAT TYPE OF RESEARCH IT IS. THAT INCLUDES MANUSCRIPTS, ABSTRACTS, JOURNALS, THESES, DISSERTATIONS, NOTES, I DON'T KNOW, EVERYTHING. IF IT'S GOING TO THE PUBLIC WE WANT TO SEE IT FIRST. I WOULD LIKE TO SAY THAT WE USUALLY ARE PRETTY LENIENT. WE REVIEW IT. WE'VE ONLY DISAPPROVED A FEW OVER THE YEARS. SOMETIMES WE WILL HAVE SOME SUGGESTIONS BUT FOR THE MOST PART MOST OF OUR RESEARCHERS ARE TRUSTWORTHY. WE DO NOT ALLOW PASSIVE APPROVAL. WE HAVE HAD SOME GRANT OPPORTUNITIES AND SOME PROJECTS THAT SUGGESTED A PASSIVE APPROVAL OF RESEARCH, IF WE DON'T -- OR PRESENTATIONS IF WE DON'T REPLY WITHIN A CERTAIN PERIOD OF TIME. ACCORDING TO OUR POLICIES WE NEVER ALLOW PASSIVE APPROVAL. BUT WE DO HAVE IN OUR POLICIES THAT WE WILL RESPOND TO YOU WITHIN 45 DAYS. SO THAT IS FOR US THAT WE PROMISE TO THE RESEARCHER THAT WE WILL HAVE A RESULT TO THEM WITHIN 45 DAYS. >> (INAUDIBLE) YOU'LL HEAR FROM US WITHIN 45 DAYS. >> : AND WE MAKE SURE THEY REPRESENTATIVE THE CHICKASAW NATION WITHOUT A STIGMA OR ANY HARM TO THE COMMUNITY. THIS IS A FAIRLY NEW ONE THAT WE'VE ADDED, ALL PROPOSED RESEARCH PROJECTS MUST BE APPROVED BY THE CHICKASAW NATION'S DESIGNATED REVIEW BODY OR THE IRB REGARDLESS OF REVIEW BY ANY OTHER EXTERNAL REVIEW ENTITY. WE FEEL THAT'S A VERY IMPORTANT ONE. WE DO HAVE AN INVESTIGATOR AGREEMENT, WE HAVE INVESTIGATORS SIGN PRIOR TO DO RESEARCH WITH US. IT IS BASICALLY A CONTRACT. AND ALL OF THESE THINGS ARE LINED UP WITHIN THAT CONTRACT, INCLUDING THAT -- THE DATA, THE FINDINGS THAT ARE GENERATED SHALL BE SOLE OWNERSHIP OF SAME, SHALL BE RETAINED AND VESTED WITH THE CHICKASAW NATION, MULTI-TRIBAL DATA SHOULD NOT BE PRESENT PRESENTED AS REPRESENTATIVE OF ANY PARTICULAR TRIBE, ONLY AS REPRESENTATIVE OF THE INDIVIDUAL PARTICIPANT. VERY IMPORTANT RULE FOR US, ESPECIALLY WHEN WE DEAL WITH SO MANY DIFFERENT TRIBES. AND THAT WAY WHEN SOMEONE RECRUITS A CHEROKEE NATION PARTICIPANT AT ONE OF OUR FACILITIES, AND THEN WHEN THEY REPORT ON THOSE RESULTS THEY DON'T SAY THAT CHEROKEE NATION IS REPRESENTED BY THIS ONE PERSON. WE MAKE SURE THE PRESENTATIONS ARE VERY CLEAR ON WHAT'S BEING REPRESENTED, AND AGAIN RESULTS CANNOT BE GENERALIZED TO AN ENTIRE TRIBE, ONLY TO THE PARTICIPANTS THAT WERE RECRUITED. WE DO HAVE AN EXEMPT POLICY WHERE WE DO EXEMPT SOME RESEARCH HOWEVER WE DON'T EXEMPT PRESENTATION, AN EXEMPT POLICY WOULD STILL HAVE TO SEND THOSE THROUGH THE IRB FOR REVIEW. AND, AGAIN, WITH THE EXEMPT POLICY BASICALLY THE RESEARCHER CANNOT DECIDE THAT THIS IS AN EXEMPT POLICY -- EXEMPT PROJECT. ONLY THE IRB CAN MAKE THAT DECISION. AND JUST THE BEGINNING LANGUAGE OF OUR RESEARCH INVESTIGATOR AGREEMENT, IT'S ABOUT 2 1/2 PAGES LONG, VERY LEGAL HEAVY. IT WAS CREATED BY OUR LEGAL DEPARTMENT. JUST TO SHOW YOU LEGALESE WITHIN THAT INVESTIGATOR AGREEMENT. AGAIN, THESE ISSUES, THESE BULLETS THAT WERE IN THE PREVIOUS SLIDE ARE ALL -- THOSE WERE IN OUR POLICY. WE PUT THEM IN OUR RESEARCH INVESTIGATOR AGREEMENT, TO SHOW THEY HAVE TO SIGN OFF ON THAT. SO THAT THE RESEARCHER SIGNS OFF SAYING THEY UNDERSTAND THAT TRIBE OWNS THE DATA, WE'RE GOING TO REVIEW PUBLICATIONS, AND CAN'T DISSEMINATE OR PRESENT WITHOUT GOING THROUGH US FIRST. WE PROVIDE ALL OF OUR RESEARCHERS WITH OUR POLICIES AS WELL. ALL OF OUR RESEARCH DOCUMENTS UP FRONT, THEY KNOW BEFORE -- (INAUDIBLE) -- THEY DON'T WANT TO DO IT. THAT'S FINE. RESEARCH AGREEMENT, ALL RESEARCHERS HAVE TO FIND, WE PROVIDE ALL THAT UP FRONT. IT'S VERY TRANSPARENT, AND WE'LL GET ON THE PHONE AND TALK TO THEM, WHATEVER THEY WANT TO DO, TO DISCUSS THIS. EVERYBODY KNOWS WHAT'S BEING DONE. >> THESE ARE SOME ITEMS THAT WE WILL ADD TO DOCUMENTS SUCH AS PHI AUTHORIZATION OR CONSENT FORMS THAT THE UNIVERSITY USES, AND WE'LL ADD THESE IN THERE TO HELP SUPPLEMENT OUR POLICIES AND TO HELP KIND OF CEMENT IT WITHIN THE PROJECT THAT THINGS LIKE THERE IS NO BROAD CONSENT, SO IF YOU'RE GOING TO COLLECT SPECIMENS WE HAVE TO KNOW EXACTLY WHAT TESTS WILL BE RUN ON THEM SO THERE'S NO -- YOU KNOW -- OR ANY GENOMIC RESEARCH, EXACTLY WHAT GENES YOU'RE LOOKING AT, THE CONSENT COVERS THOSE THINGS, NO BROAD CONSENT. WE PUT AN EXPIRATION DATE ON SUBMISSION, FIVE YEARS AFTER THE END OF THE PROJECT. AFTER THAT, YOU CAN'T USE THE DATA ANYMORE WITHOUT COMING BACK TO US. SO NO RECRUITMENT LISTS, WE WON'T PROVIDE TRIBAL ROLES, WE DON'T JUST PROVIDE PARTICIPANTS FROM OUR HEALTH SYSTEM. WE ONLY DO THAT. NO LANGUAGE REQUIRING PARTICIPANT COSTS FOR ADDITIONAL CARE, SOMETIMES WE'LL SAY IF YOU INCUR, YOU KNOW, INCUR, YOU KNOW, AN INJURY OR SOMETHING, YOU'RE RESPONSIBLE FOR THAT COST, THAT DON'T WORK IN INDIAN WORLD. WE TAKE THAT OUT AND INSERT A LOCAL CONTACT PERSON, USUALLY BOBBY AS OUR HUMAN SUBJECTS INVESTIGATORS THAT THEY CAN CONTACT HIM. REPOSITORIES, WE HAVE A COUPLE THAT WE USE RIGHT NOW AND WE REQUIRE A SEPARATE CONSENT FORM, VERY SPECIFIC, AND IT'S AN OPT OUT/OPT IN SITUATION WHETHER THEY CAN PARTICIPATE IN THE PROJECT BUT OPT OUT OF THE REPOSITORY. >> I WILL SAY I GOT PERMISSION THAT IF ANYBODY WANTS COPIES OF OUR POLICIES OR OUR RESEARCH AGREEMENTS, WE CAN MAKE THOSE AVAILABLE SO JUST LET US KNOW OR I CAN SEND THEM TO KENDRA OR SOMEBODY, SO IF YOU WOULD LIKE COPIES OF THOSE, WE GOT PERMISSION TO SHARE THOSE FREELY SO THEY SAID THAT'S WHAT WE WERE HERE FOR. WE SAID OKAY. USUALLY THEY ARE TOUGHER ON THAT KIND OF STUFF SO WE'LL BE GLAD TO DO THAT FOR YOU BECAUSE WE'RE GOING THROUGH THEM QUICKLY. I WANT TO SHARE, AGAIN, ONCE AGAIN A UNIQUE THING ABOUT OKLAHOMA. WE HAVE FOUR IRBs, ACTUALLY MAYBE FIVE, SOMEBODY TOLD ME THAT CREEK NATION JUST GOT AN IRB TOO SO CHEROKEE NATION, US, CHOCTAW NATION, AND THE OKLAHOMA CITY AREA INDIAN HEALTH SERVICE HAVE IRBs, SO WE'RE PRETTY WELL COVERED. ALL OF US HAVE BEEN AROUND A WHILE SO WE'RE PRETTY WELL COVERED AS FAR AS RESEARCH PROTECTIONS GO AND WE WORK REALLY WELL TOGETHER, OUR TRIBAL PARTNERS, AND OUR IHS PARTNER, WE WORK WELL TOGETHER, COLLABORATING ON COMMON RESEARCH PROJECTS, LIKE THE TODAY STUDY, WHICH WAS A MULTI-SITE STUDY, THREE SITES IN OKLAHOMA PARTICIPATE IN THE TODAY STUDY. OUR IRBs WORKED TOGETHER AS WELL. WE HAVE A LOT OF OVERLAP. SOME AREAS, CHALLENGES WE HAVE, WE HAVE DIFFERENT CULTURES AND DIFFERENT TRIBES AND IHS AS WELL. WE MAY HAVE DIFFERENT PERSPECTIVES ON TRIBAL PROTECTIONS AND MAYBE SOME INTERPRETATIONS OF DIFFERENT ETHICAL ISSUES, BUT WE TRY TO WORK THOSE OUT. WE ALSO HAVE SOME STRUCTURAL DIFFERENCES. I KNOW WE'RE PROBABLY A CHICKASAW NATION, A LITTLE MORE SCIENTIFIC HEAVY ON OUR IRB. CHOCTAW NATION IS COMMUNITY HEAVY ON THEIR IRB SO THERE ARE SOME STRUCTURAL DIFFERENCES IN OUR IRBs AS WELL. OF COURSE WE OVERLAP A LITTLE BIT SOMETIMES IN OUR JURISDICTION, AND SO THOSE ARE ISSUES WE HAVE TO WORK OUT. WE'RE ALL WITHIN OKLAHOMA, WE HAVE THE SAME TYPES OF JURISDICTIONAL ISSUES IF THE CHEROKEE PERSON COMES DOWN TO CHOCTAW, I MEAN TO CHICKASAW NATION TO GET SOME HEALTH CARE AND WE HAPPEN TO ENROLL THEM IN A PROJECT WHAT KIND OF JURISDICTIONAL ISSUE IS THERE, SO THERE ARE THOSE KIND OF THINGS. AND OF COURSE WE ALL HAVE OUR PERSONAL AND PHILOSOPHICAL DIFFERENCES AS WELL, AMONGST OUR IRB MEMBERS AND OUR IRB CHAIRS AND SO WE HAVE TO WORK THOSE OUT AS WELL. ONE OF THE GAPS WE HAVE IN IHS JURISDICTION, IHS ONLY COVERS HEALTH RESEARCH DONE IN THEIR FACILITIES AND SOMETIMES THERE ARE SOME NON-HEALTH RESEARCH DONE IN SOME TRIBAL AREAS THAT AREN'T COVERED BY IHS IRB OR BY TRIBAL IRBs AS WELL. I MENTIONED EARLIER WE EVALUATE NON-HEALTH RESEARCH AS WELL SO THERE ARE SOME GAPS BUT I KNOW IHS IRB WILL DO WHAT THEY CALL A -- IT'S A -- KIND OF A -- THEY WILL DO IT FOR THEM, YOU KNOW, IT'S NOT REALLY AN OFFICIAL REVIEW, YOU KNOW, BUT IT'S KIND OF A REVIEW THEY WILL DO FOR THEM JUST TO HELP THEM OUT. I CAN'T THINK OF THE TERM. COURTESY, THANK YOU. IT'S A BIG WORD AND I HAVE TROUBLE WITH BIG WORDS. [LAUGHTER] SO COURTESY REVIEW, SOME IRB WILL DO FOR SOME TRIBES THAT DON'T HAVE OTHER COHORTS AS WELL. THANK YOU, MICHAEL. OF COURSE THERE'S A LOT OF BENEFITS FROM HAVING SO MANY IRBs, SO PROFESSIONAL, SO EXPERIENCED, ALL IN ONE AREA WHERE WE CAN COLLABORATE TOGETHER. I THINK WE REALLY HAVE DEVELOPED A COMMUNITY OF ETHICAL TRIBAL RESEARCH REVIEW IN OKLAHOMA, AND WE CHALLENGE EACH OTHER AND WE PROMOTE OUR PROFESSIONAL COMPETENCE. WE'RE A SOUNDING BOARD FOR EACH OTHER FOR NEW ISSUES THAT COME UP. ALL OF YOU KNOW IN THIS ARENA WITH DATA SHARING THERE ARE NEW ISSUES ALL THE TIME SO WE HAVE EACH OTHER , A REALLY TIGHT-KNIT COMMUNITY TO SERVE AS SOUNDING BOARDS AND EDUCATE EACH OTHER AND WORK TOGETHER TO FACILITATE PROCESSES WITH RESEARCH PARTNERS. IF WE HAVE A MULTI-SITE TRIAL IN OKLAHOMA WE'RE TAKING PART IN WE'RE NOT GOING TO MAKE IT HARD ON RESEARCHERS SO THEY HAVE TO DO FOUR OR FIVE CONSENTS. WE TRY TO STREAMLINE OUR CONSENT AND TRY TO CONSOLIDATE THEM WITHIN OUR TRIBAL DIFFERENCES AS MUCH AS WE CAN SO THAT WE CAN MAKE IT A LITTLE BIT EASIER ON THE RESEARCHERS. WE DON'T WANT TO CAUSE PROBLEMS. WE WANT TO FACILITATE RESEARCH BUT WE WANT TO MAKE SURE IT'S DONE CORRECTLY. BECAUSE THAT IS OUR JOB, YOU KNOW, OUR GOAL IS THE HIGHEST LEVEL OF PROTECTIONS FOR OUR PARTICIPANTS AND FOR OUR COMMUNITIES. THERE'S OUR CONTACT INFORMATION. AGAIN, WE'LL BE GLAD TO SHARE OUR POLICIES, WHATEVER DOCUMENTS WE MIGHT HAVE, WE'LL BE GLAD TO SHARE WITH YOU. THANK YOU VERY MUCH. >> : THANK YOU SO MUCH, BOBBY AND MICHAEL. [APPLAUSE] WE APPRECIATE THAT. I APPRECIATE THE TIME CONSIDERATION THERE. AND I'LL JUST SAY TO REMIND EVERYBODY THAT BOBBY'S AROUND ALL DAY TODAY AND ALL NIGHT TONIGHT SO IF YOU HAVE QUESTIONS, GO RIGHT OVER THERE AND ASK HIM. WITH THAT, I'M GOING TO GO AHEAD AND THROW IT OVER TO PRESIDENT KILLSBACK FOR OUR NEXT SECTION. >> THANK YOU. THANKS AGAIN TO THE CHICKASAW AND WHAT YOU GUYS ARE DOING THERE IN OKLAHOMA, AND THAT IS VERY ENLIGHTENING THAT YOU ARE WILLING TO SHARE THAT INFORMATION WITH US, THOSE DOCUMENTS THAT, AGAIN, SAVES A LOT OF MONEY FOR TRIBES WHO ARE LOOKING TO DEVELOP THOSE TYPES OF PROCESSES AT THE LOCAL LEVEL. AND THAT'S SOMETHING THAT I KNOW IN MY REGION WE STRUGGLE WITH IS OUR RESOURCES, SO I APPRECIATE THAT FROM ONE NATION TO ANOTHER NATION. WITH THAT I WANT TO INTRODUCE OUR NEXT GUESTS, THIS IS THEIR COMMITTEE, HIS COMMITTEE, AND I WANT TO, AGAIN, CONGRATULATE HIM ON HIS REAPPOINTMENT, DR. FRANCIS COLLINS. CAN WE GIVE HIM A ROUND OF APPLAUSE? [APPLAUSE] HE WAS APPOINTED THE 16th DIRECTOR OF THE NATIONAL INSTITUTES OF HEALTH BY PRESIDENT BARACK OBAMA AND CONFIRMED BY THE SENATE AND ON JUNE 6, 2017, PRESIDENT TRUMP ANNOUNCED HIS SELECTION FOR DR. COLLINS TO CONTINUE TO SERVE AS THE NIH DIRECTOR. DR. COLLINS IS THE PHYSICIAN GENETICIST NOTED FOR LANDMARK DISCOVERIES IN GENES AND LEADERSHIP IN THE HUMAN GENOME PROJECT WHICH WE GOT TO GIVE THE PRESENTATION LAST YEAR WHICH I TOLD A LOT OF MY YOUTH BACK AT HOME, SHOWED THEM THE PICTURE, THEY WERE BLOWN AWAY BECAUSE THEY HAD READ SOME ARTICLES A WHILE BACK IN SOME OF OUR BIOLOGY CLASSES. SO I TOLD THEM I MET THE MAN. [LAUGHTER] BUT WITH THAT, I'LL TURN IT OVER TO YOU, DOCTOR. AND WELCOME. >> WELL, THANK YOU VERY MUCH. IT'S A PRIVILEGE TO BE ABLE TO MEET WITH THIS DISTINGUISHED GROUP AND HAVE A CHANCE FOR CONVERSATION. THIS YEAR SINCE UNFORTUNATELY I'VE GOT ANOTHER COMMITMENT I CAN ONLY STAY FOR 30 MINUTES, I THOUGHT I WOULD NOT LECTURE FOR THAT TIME AVAILABLE BUT RATHER REALLY SEEK TO HAVE A CONVERSATION WITH YOU ABOUT THE ISSUES THAT ARE ON YOUR MIND. AND WE HAVE A LOT OF MATERIAL THAT YOU ARE BEING PRESENTED WITH, AND DISCUSSING IN THE COURSE OF THIS PARTICULAR MEETING. AND I'VE LOOKED AT THE AGENDA AND I ADMIRE YOUR ABILITY TO SIFT THROUGH SO MANY TOPICS IN JUST A DAY OR TWO. AND I HOPE THAT THE STAFF THAT WE HAVE HERE AND PARTICULARLY DR. WILSON AND DR. ANDERSON ARE GIVING YOU THE BACKGROUND YOU NEED AND FOLLOWING UP ON THE THINGS THAT MAY COME UP IN THE COURSE OF DISCUSSION. I HAVE WITH ME DR. LARRY TABAK, PRINCIPAL DEPUTY DIRECTOR, A VERY STRONG ADVOCATE FOR THE IMPORTANCE OF PAYING ATTENTION TO THE CONCERN OF THE TRIBES IN EVERYTHING WE DO AND I'M ONE OF THOSE AS WELL. ALSO WANT TO POINT OUT DR. CARRIE WOLINETZ, RAISE YOUR HAND, THE ACTING CHIEF OF STAFF FOR NIH WHO ALSO CAME OVER FOR THIS PART OF THE CONVERSATION. I KNOW YOU'VE HAD MANY DISCUSSIONS IN THIS MEETING AND BEFORE THIS ABOUT SUCH ISSUES AS DATA ACCESS, ABOUT WHAT'S HAPPENING WITH THAT "ALL OF US" STUDY THAT AIMS TO ENROLL A MILLION PEOPLE STUDYING HEALTH AND ILLNESS. I KNOW ALSO IN INDIAN COUNTRY THERE'S A LOT OF CONCERN AS THERE IS EVERYWHERE ELSE ABOUT WHAT'S HAPPENING WITH OPIOIDS AND I WILL TELL YOU PERSONALLY I'VE BEEN SPENDING A LOT OF TIME TRYING TO IDENTIFY WAYS NIH COULD HELP COME FORWARD WITH SOME RESEARCH CONTRIBUTIONS TO ENDING THIS TERRIBLE EPIDEMIC WHICH IS TAKING SO MANY LIVES, AND I'D BE GLAD TO TALK ABOUT SOME OF THOSE ISSUES AS WELL. AGAIN, I THINK WHAT I HAVE LEARNED OVER NOW ALMOST 25 YEARS AT NIH IS THAT WHEN IT COMES TO HAVING THESE CONVERSATIONS ABOUT RESEARCH, AND HOW IT PLAYS OUT IN YOUR COMMUNITIES, I NEED TO BE A BETTER LISTENER AND A LESS VOCAL PRESENTER. AND SO THAT'S PARTLY WHY I WANT TO BE HERE IN LISTENING MODE THIS AFTERNOON BECAUSE I'M SURE I'VE STILL GOT A LOT MORE TO LISTEN AND A LOT MORE TO LEARN FROM YOUR PERSPECTIVE ABOUT THOSE ISSUES I'VE JUST MENTIONED, AS WELL AS ANY OTHERS. SO INSTEAD OF SORT OF GOING THROUGH ANY KIND OF AN OUTLINE, THINGS FROM MY PERSPECTIVE, I WOULD LIKE TO OPEN IT UP TO ALL OF YOU AND SEE WHAT QUESTIONS, POINTS YOU WOULD LIKE TO PUT OUT THERE FOR THE NIH DIRECTOR TO CONSIDER, AND WHEN I HAVE TO GO AFTER THE FIRST HALF HOUR DR. TABAK WILL STAY AND SO DR. ANDERSON WILL BE HERE AS WELL FOR ANOTHER HALF HOUR TO CONTINUE THAT CONVERSATION. AGAIN, MY APOLOGIES THAT I CAN'T STAY FOR THE WHOLE HOUR. BUT PLEASE, WHAT ARE THE THINGS THAT YOU ALL WOULD MOST LIKE TO SPEND OUR TIME ON? >> I'M NOT NECESSARILY STARTING BUT MIGHT ENCOURAGE THE REST OF THE BOARD. WE HAD A CAUCUS. I HAVE A WRITTEN QUESTION BUT I'LL SEE IF CHESTER MAKES IT BACK IN PERHAPS. BUT WE HAVE QUESTIONS. AND WE HAD CONVERSATIONS DURING OUR CAUCUS. LIKE I SAID, NOW IS THE TIME TO GO AHEAD AND BRING THOSE TOPICS UP. IF YOU HAVE A QUESTION, LET'S JUST DO IT. >> HI, DENISE DILLARD FROM ALASKA. GOOD TO SEE YOU AGAIN. I HAD A QUESTION ABOUT -- SO WE'VE HAD SEVERAL PRESENTATIONS TODAY ABOUT DATA SHARING, AND I KNOW THAT THERE HAVE BEEN EXCEPTIONS MADE TO THE WIDE DATA SHARING THAT MIGHT BE ENCOURAGED BY NIH. BUT OUR UNDERSTANDING IS THAT THERE'S QUITE A BIT OF VARIABILITY ACROSS THE INSTITUTES OR MAYBE ACROSS PROGRAM OFFICERS, WHEN THE ALTERNATIVES TO FREE DATA SHARING, WHEN THOSE ARE APPROVED AND WHEN THEY ARE NOT APPROVED. AND I GUESS I'M TRYING TO KIND OF UNDERSTAND THAT BECAUSE REALLY IN MANY WAYS, WELL IN ANY WAY, THE ETHICS UNDERLYING KIND OF THE NEEDED EXCEPTIONS TO DATA SHARING IN TERMS OF POTENTIAL FOR STIGMATIZATION, THE ROLE OF TRIBAL SOVEREIGNTY, ALL OF THOSE THINGS ARE THE SAME. SO I GUESS PART OF MY QUESTION IS HONESTLY I'M TRYING TO FIGURE OUT LIKE HOW DOES NIH WORK AND IS IT INTENTION YELL -- INTENTIONALLY SET UP THAT EACH OF THE 27 INSTITUTES CAN DECIDE WHEN TO MAKE EXCEPTIONS TO DATA SHARING OR DO YOU DECIDE AS DIRECTOR OR IS THERE A POLICY COMMITTEE, WHO ARE WE TRYING TO TALK WITH? >> YOU RAISE A TERRIFIC QUESTION. I'M AFRAID THAT OUR HOUSE IS NOT COMPLETELY IN ORDER AND YOU'VE IDENTIFIED THAT. NIH OF COURSE HAS THIS LONG AND COMPLICATED HISTORY OF HAVING BEEN FORMED INSTITUTE BY INSTITUTE OVER THE YEARS. I WOULD SAY UNTIL THE LAST 20 YEARS OR SO, A LOT OF THE INSTITUTES FUNCTIONED REALLY PRETTY AUTONOMOUSLY. THERE'S BEEN A GRADUAL AND HOPEFULLY CONTINUING TREND TOWARDS TRYING TO HAVE MORE AGREED UPON POLICIES ACROSS ALL OF THE 27 INSTITUTES AND CENTERS, BUT THE CONGRESS GIVES THE BUDGET FOR EACH CENTER AS A LINE ITEM SO THE INSTITUTE DIRECTORS TO THAT EXTENT HAVE A FAIR AMOUNT OF AUTHORITY OVER WHAT THEY DECIDE TO DO. THERE ARE LIMITS THOUGH, AND THIS IS ONE OF THEM, TO THE POINT THAT JUST DOESN'T REALLY SERVE THE NEEDS OF THE PEOPLE THAT WE'RE REALLY HERE TO SERVE, WHICH IS THE TAXPAYERS, THE PEOPLE WHO LIVE IN THE COUNTRY AND ALL OF YOU. AND I THINK YOU HAVE PUT YOUR FINGER ON ONE OF WHAT MIGHT BE A SIGNIFICANT LIST OF AREAS WHERE THERE'S NOT CONSISTENCY BETWEEN INSTITUTES IN TERMS OF HOW THEY HANDLE IMPORTANT ISSUES THAT RELATE TO CLINICAL RESEARCH. I'M GLAD YOU RAISED IT. AND I GATHER THIS HAS BEEN SOMETHING THAT'S BEEN DISCUSSED A LITTLE BIT AROUND THE TABLE TODAY. I THINK, LARRY, JIM, THIS IS THE KIND OF TOPIC WHICH WHEN WE BRING THE INSTITUTES TOGETHER AROUND THE TABLE AS WE DO EVERY THURSDAY MORNING TO TALK ABOUT WHY WE NEED TO BE BASICALLY ONE ORGANIZATION WITH ONE PERSPECTIVE ABOUT HOW TO DO THINGS RIGHT. WE SHOULD SEEK TO HARMONIZE THIS. I WANT TO SAY FOR MYSELF, YOUR TRIBAL SOVEREIGNTY AND WHAT IT MEANS THEN IN TERMS OF THE OPPORTUNITY FOR WAIVERS FROM DATA ACCESS ISSUES, PARTICULARLY WHEN IT COMES TO CLINICAL TRIALS, ARE REALLY CRITICAL, NEED TO BE HONORED AND NEED TO BE HONORED CONSISTENTLY. AND I WOULD AT THE PRESENT TIME NOT BE ABLE TO SAY CONFIDENTLY THAT WE'RE QUITE WHERE WE SHOULD BE. SO I WILL TAKE THIS AS AN ACTION ITEM OF SOMETHING WE NEED TO WORK ON. >> HI, CHIEF LYNN MILLER, MOHEGAN IN CONNECTICUT, REPRESENTING USET, USET WANTED TO THANK YOU FOR RESTORING THE FUNDING TO THE TRIBAL EPIDEMIOLOGY CENTERS, AND SO THEY WERE THANKFUL FOR THAT, AND THEY ALSO THOUGHT THAT, YOU KNOW, AS TRIBAL -- THAT TRIBAL SET ASIDES ARE CRITICAL, AND, YOU KNOW, WHEN INVOLVING TRIBAL NATIONS IN RESEARCH. SO THEY ARE HOPING THAT, YOU KNOW, THERE WILL BE A LESS CUMBERSOME PROCESS IN THE FUTURE. I THINK THE FUNDING WAS THERE AND THEN IT WASN'T, SO IT WAS A LARGE PROCESS THIS YEAR BUT LOOKS LIKE IT MAY BE STREAMLINED FOR NEXT YEAR. BUT ONE OF THE QUESTIONS THAT THEY HAD WAS WHAT WILL DAVE WILSON'S ROLE BE IN EVALUATING RESEARCH, TRIBAL RESEARCH, BECAUSE WHAT THEY ARE THINKING IS THAT THERE'S A LOT OF VARIABILITY IN INDIAN COUNTRY AND THERE ARE VERY SPECIFIC ISSUES IN INDIAN COUNTRY AND THEY HAVE ACTUALLY EXPERIENCED SOME DECLINATIONS FOR RESEARCH BASED ON THE FACT THE REVIEWERS DIDN'T REALLY UNDERSTAND HOW INDIAN COUNTRY WORKS, AND SOME OF IT WAS AROUND THE TIMELINESS AND MOST TRIBAL ORGANIZATIONS TAKE A LITTLE WHILE TO COME TO CONSENSUS. AND SO THEY WONDERED IF THERE WOULD BE SOME EXPERT REVIEW, WHEN THERE IS TRIBAL RESEARCH BEING PROPOSED. >> WELL, IT'S ANOTHER EXCELLENT QUESTION. AND I THINK ONE OF THE REASONS TO HAVE THE TRIBAL HEALTH RESEARCH OFFICE IS TO PROVIDE THAT KIND OF EXPERT ADVICE, ACROSS ALL OF NIH, WHEN THIS KIND OF ISSUE COMES UP AND TO TRY TO JUST AS WE WERE TALKING ABOUT A MINUTE AGO IN TERMS OF WAIVERS FOR ACCESS TO MAKE SURE THERE'S CONSISTENCY IN THE WAY RESEARCH APPLICATIONS ARE REVIEWED. I ACTUALLY DON'T KNOW WHAT THE CURRENT CIRCUMSTANCE IS, MAYBE DAVID CAN FILL US IN. I WOULD HOPE AS A MINIMUM THERE'S THIS INFORMAL POSSIBILITY WHERE INSTITUTES RECOGNIZING WE NOW HAVE AN AREA OF STRENGTH HERE, IN THRO WORK BE UTILIZING IT TO SEEK ADVICE WHEN THESE ISSUES COME UP. HAS THAT BEEN HAPPENING AND SHOULD WE BE DOING MORE? >> THANK YOU, DR. COLLINS. THANK YOU FOR THE QUESTION, CHIEF. ABSOLUTELY WE HAVE -- WE'VE HAD INITIAL CONVERSATIONS WITH IT'S CENTER FOR INITIAL REVIEW, WE'RE EXPLORING OPPORTUNITIES TO BEGIN TO SEE WHAT THE PROCESS LOOKS LIKE AND WHERE WE CAN IDENTIFY AREAS FOR IMPROVEMENT. THAT PROCESS IS BEGINNING. >> : R. >> R. R. >> I WANT TO REASK WHAT I'VE DONE IN THE PAST, IF YOU HAVE PEOPLE THAT COULD SERVE AS REVIEWERS, IF YOU COULD BRING THAT TO TO OUR ATTENTION WE KNOW SOME OF THOSE PEOPLE BUT WE DON'T KNOW ALL OF THEM. AND IT WOULD BE ENORMOUSLY HELPFUL TO US IF YOU WOULD SAY TODAY, YOUR RECOMMENDATIONS, BECAUSE THAT WAY, WHEN THE OPPORTUNITY COMES UP AND HE DOESN'T HAVE TO FIND THE RIGHT -- IT'S JUST, HERE THEY ARE. THIS EXPERTISE, THAT EXPERTISE AND SO FORTH. I THINK THAT WOULD BE -- IT'S BEEN HELPFUL IN THE PAST AND MORE SO AS WE GO FORWARD. >> CAN I JUST ADD ONE THING TO THE DISCUSSION ABOUT CSR? I KNOW I CERTAINLY SENT NAMES OF FOLKS THAT I HAVE BEEN ABLE TO IDENTIFY, AND I THINK MAYBE THAT IS A GOOD -- REASONABLE PLACE TO START. BUT I THINK THERE IS A LARGER ISSUE OF HOW THE REVIEW PROCESS IN GENERAL KIND OF FAVORS CERTAIN TYPES OF QUOTE, CREDENTIALS OVER THE OTHERS. SO I HOPE THERE WOULD BE CONTINUED DISCUSSION OF THE UNDERLYING PROCESSES AND BIASES THAT REALLY LEAVE FOR MORE AND MORE OF THE SAME TYPES OF GRANTS TO GET FUNDED TO THE EXCLUSION OF OTHER TYPES. I WANTED TO MAKE SURE THAT THAT WAS STILL PART OF THE CONVERSATION. >> GOOD AFTERNOON Mr. COLLINS AND Mr. TABAK I BELIEVE I RECOMMENDED TO LET YOU KNOW, THE OTHER QUESTION OR MAYBE A RECOMMENDATION THAT YOU WOULD CONSIDER IS HAVING DISCUSSIONS ON THE NATIVE SPECIMENS BIOBANK, WHICH INCLUDES NATIVE SPECIMENS, OR WILL INCLUDE NATIVE SPECIMENS. AT THIS POINT, AS I UNDERSTAND IT, IT IS PRETTY MUCH OPEN FOR ANY RESEARCHER TO UTILIZE THESE SPECIMENS FOR ANY RESEARCH THAT THEY WANT TO DO. I HAVEN'T SEEN ANY GUIDELINES OR RESTRICTIONS ON WHATEVER THAT MIGHT BE. BUT I THINK THAT A DISCUSSION LIKE THAT WOULD DO US WELL AS WHERE IT CONCERNS THE NATIVE SPECIMENS. JUST A DISCUSSION, AND MAYBE WE'LL GET SOMEWHERE. BECAUSE I KNOW THAT WE GET A LITTLE ITCHY WHEN IT COMES TO SOMETHING OF THAT MAGNITUDE BECAUSE IT HAS A LOT OF POTENTIAL TO DO GOOD BUT ALSO TO THE OTHER SIDE, NOT SO GOOD. SO I'M JUST RECOMMENDING THAT MAYBE WE CAN HAVE SOME FOLKS SIT DOWN AND DISCUSS THAT. >> SPECIFICALLY TO THE ALASKA BIOBANK? >> NO, I'M REFERRING TO ALL OF US. >> THE ALL OF US BIOBANK? GOT YOU. I CAN SAY A LITTLE BIT ABOUT THAT, AND WE WILL BE HERE TALKING SPECIFICALLY TOMORROW ABOUT THIS AND CAN PROBABLY GIVE YOU MORE DETAILS. SO THE BIOBANK IS AT THE MAYO CLINIC AND IT IS INTENDED TO BE THE REPOSITORY FOR BLOOD AND URINE SPECIMENS FROM THOSE WHO AGREE TO PARTICIPATE IN THIS MILLION AMERICAN EFFORT TO TRY TO UNDERSTAND HEALTH AND DISEASE. IT WILL BE OVER SEEN BY A REVIEW PROCESS TO MAKE SURE THAT THOSE SPECIMENS ARE ONLY UTILIZED FOR RESEARCH THAT IS CONSISTENT WITH THE CONSENT THAT THE INDIVIDUALS WHO PARTICIPATED HAVE SIGNED ON TO, BECAUSE WE DON'T WANT TO SEE THINGS BEING DONE THAT PEOPLE WOULD NOT HAVE APPROVED OF WHEN THEY AGREED TO BE PART OF THIS AND THESE ARE GOING TO BE EXHAUSTIBLE SPECIMENS. YOU DON'T WANT THEM TO GET FRITTERED AWAY ON SILLY QUESTIONS WHEN YOU COULD HAVE ASKED IMPORTANT ONES. THERE WILL BE A PROCESS. I DON'T THINK AT THE MOMENT THAT HAS BEEN FULLY FLUSHED OUT. THE ALL OF US PROGRAM IS STILL IN THE BETA TESTING PHASE AND MANY OF THOSE ISSUES IN TERMS OF GOVERNANCE ARE ONLY IN DRAFT FORM. DARA COULD PROBABLY TELL YOU A BIT MORE TOMORROW ABOUT THIS IF YOU'LL RAISE THAT -- OR I CAN SEND HER A NOTE AND TELL HER TO EXPECT THE QUESTION. >> OKAY, YES, BECAUSE IT IS THE OPPORTUNE TIME TO DO SO. THANK YOU. >> HI, THERE, DR. COLLINS AND DR. TABAK, THE NATIVE VILLAGE OUT OF ALASKA. I WANTED TO RELAY SOME OF THE CONVERSATIONS WE HAVE BEEN HAVING ACROSS A NUMBER OF DIFFERENT ISSUES FOR ME COME DOWN TO THE QUESTION OF RESPONSIBILITY AND SO WHETHER WE ARE TALKING ABOUT THE 27 DIFFERENT INSTITUTES AND CENTERS AND TRYING TO UNDERSTAND CONSISTENTY AND TRANSPARENCY, WITH RESPECT TO THE ALL OF US PIECE, I THINK I DO HAVE SOME QUESTIONS ABOUT WHERE THE ROLE AND RESPONSIBILITY OF INDUSTRY AND HOW THE CONVERSATIONS WITH NIH AND INDUSTRY ARE HAPPENING. WHEN I SAY THAT, I'M CERTAINLY THINKING ABOUT PHARMACEUTICAL COMPANIES AND FOLKS WHO DRIVE SOME OF THE ECONOMICS BEHIND THIS. THE PRESENTATION TODAY RAISED A QUESTION OF WHY IS NIH INVESTED IN DATA SHARING AND HELPING US TO THINK ABOUT THAT QUESTION. AND THEN USING THAT AS SPACE TO TALK ABOUT WHY THESE KINDS OF EFFORTS ARE IMPORTANT AND DO SOME OF THAT EDUCATION. SO I THINK THAT IS SOMETHING WE ARE THINKING ABOUT AS FOLKS WHO STEWARD SOME OF THIS WORK WHO IS RESPONSIBLE. WHO IS DRIVING IS THIS? WHAT IS THE MOTIVATION? WHAT IS THE INTENT? JUST TO RELAY THAT BACK TO YOU IN TERMS OF HELPING US TO UNDERSTAND IN OUR ROLE AS EDUCATING AND LEADING THAT. IN THE SAME VEIN, DR. HOLES PRESENTATION WAS VERY COMPELLING. SOMETHING THAT IS CONCERNING WITH THE DATA SHARING CONVERSATIONS FOR ME IS THAT I STILL AM HEARING AN EMPHASIS ON INVESTIGATOR-DRIVEN EXCEPTIONS AND THE RESPONSIBILITY ON INVESTIGATORS. BUT I'M NOT NECESSARILY HEARING THE SYSTEM OR THE INSTITUTION. THAT IS NOT JUST NIH BUT IT'S UNIVERSITIES AND THE BROADER SYSTEM THAT COULD ALSO INCLUDE INDUSTRY. SO, HOW DO WE BALANCE IN THE POLICY CONVERSATIONS AND RESPONSIBILITY OF INVESTIGATORS BUT ALSO THE RESPONSIBILITY OF SYSTEMS AND HOW CAN WE BE A PART OF STEWARDING SOME OF THAT? SO I WANTED TO BE SURE TO RELAY THAT. ONE OF THE THINGS I'M TAKING AWAY FROM TODAY AND I'M SURE WE'LL HEAR MORE TOMORROW S I GUESS I CAME IN TODAY REALLY FOCUSED ON THE DATA SHARING CONVERSATION WHICH WE HEARD ABOUT BUT FOR ME I'M TAKING AWAY THE OTHER SIDE OF THAT CONVERSATION IS ABOUT DATA USE. ONE PART OF THE CONVERSATION ABOUT HOW ARE WE ASKING FOLKS, COMMUNITIES AND INDIVIDUALS AND COLLECTIVE ORGANIZATIONS TO CONTRIBUTE INTO THESE LARGER REPOSITORIES? WHAT DOES THAT CONVERSATION LOOK LIKE? THEN WHAT ARE WE AS STEWARDS OF THAT DATA AND THE BENEFITS OF THAT, WHAT ARE OUR RESPONSIBILITIES GOING FORWARD ABOUT HOW WE STRUCTURE THE USE OF THAT INFORMATION? I DO THINK A LOT OF OUR TRIBES AND NATIVE ORGANIZATIONS HAVE A LOT TO OFFER IN THAT SPACE. SO I WANTED TO RELAY SOME OF THAT AND SAY I HOPE WE CAN HAVE SOME ONGOING CONVERSATION BUSY THAT AND WE CAN OFFER INSIGHTS AND LEARN FROM WHAT YOU'RE LEARNING ON THAT FRONT AS WELL. >> IT'S A VERY THOUGHTFUL COMMENT AND I REALLY LIKE YOU'RE DRAWING THE DISTINCTION BETWEEN DATA SHARING AND DATA USE. THEY ARE NOT THE SAME THING. IN FACT, LET ME JUST TAKE THE EXAMPLE OF CANCER. SHEAR A DISEASE WHERE WE DESPERATELY NEED TO COME UP WITH BETTER ANSWERS FOR SOME OF THE CANCERS FOR WHICH WE CURRENTLY DON'T HAVE EFFECTIVE TREATMENTS. AND IT'S A VERY EXCITING TIME FOR THAT BECAUSE WE ARE, THROUGH NEW DISCOVERIES, SOME OF THEM COMING OUT OF GENOMICS AND SOME OF THEM COMING OUT OF IMMUNOLOGY, BEGINNING TO LEARN HOW EVEN IN A SITUATION WHERE WE THOUGHT ALL HOPE WAS LOST, AND THERE ARE OPPORTUNITIES TO COME UP WITH TREATMENTS THAT CAN GIVE PEOPLE MANY YEARS OF LIFE AND MAYBE EVEN A CURE. SOME OF THE IMMUNOTHERAPY APPROACHES TO CANCER WHERE YOU'RE TAKING THE BODIES'S OWN IMMUNE SYSTEM AND GIVING IT A CHANCE TO DO ITS THING ARE SHOWING CAPABILITIES OF CURING EVEN PEOPLE WITH FAR ADVANCED MALIGNANCIES. THAT IS INCREDIBLY EXCITING. BUT THE FIELD WOULD CERTAINLY GO IN THAT AREA NOT ONLY SHARED THEIR EXCITING SUCCESS STORIES BUT ALSO THEIR FAILURES BECAUSE THAT WAY WE WOULDN'T KEEP REPEATING THE SAME DEAD ENDS, WHICH UNFORTUNATELY CAN SOMETIMES BE THE CASE. HENCE, PARTICULARLY FOR CANCER, AND CERTAINLY JOE BIDEN WHEN HE WAS ADVOCATING FOR THE CANCER MOONSHOT, REPEATEDLY SAID, IF WE COULD JUST GET PEOPLE SHARE ALL THE DATA THEY ALREADY KNEW ABOUT WITH EACH OTHER, THIS FIELD COULD GO FORWARD SO MUCH FASTER. AND I THINK HE CHAINED SOME OF THOSE WITH HOLDING INFORMATION INTO REALIZING THEY WERE NOT SERVING THE NEEDS OF THE PUBLIC. THEY WERE BASICALLY SERVING THEIR OWN NEEDS AND THAT'S NOT HOW INVESTIGATORS ARE SUPPOSED TO BE. JUST THE SAME, THIS IS INFORMATION THAT RELATES TO PEOPLE. IT RELATES TO THEIR PERSON HOOD T RELATES TO THEIR CONCERNS ABOUT PRIVACY AND HOW THIS IS GOING TO GET USED. AND SO WHAT WE HAVE DONE IN MANY OF THESE INSTANCES AND I THINK WE'LL DO THIS WITH THE ALL OF US PROGRAM, IS BOTH TO TRY TO SET UP A SYSTEM WHERE DATA IS SHAREABLE, THAT IS IT IS IN A PLACE WHERE IT CAN BE ACCESSEDS AND NOT JUST BY A SMALL GROUP OF PEOPLE WHO FEEL ENTITLED TO IT, BUT IF YOU DON'T GET TO SEE IS IT UNLESS YOU EXPLAIN THE USE THAT IS OVERSEEN BY A GROUP THAT IS REPRESENTING THE INTERESTS OF THE PARTICIPANTS WHICH MEANS IT HAS THE PARTICIPANTS ON THE GROUP. AND THE DATA USE THEREFORE IS THE SECOND LEVEL OF DECISION-MAKING ABOUT WHETHER THAT INFORMATION IS GOING TO GET USED. YOU ASKED ABOUT INDUSTRY, AND THIS HAS CERTAINLY BEEN AN ISSUE THAT MANY HAVE WONDERED ABOUT. IF WE ARE TRYING TO BENEFIT THE PUBLIC AND WE ARE CONCERNED ABOUT HOW THIS IS GOING TO BE USED, SHOULD INDUSTRY ALSO HAVE ACCESS TO THESE KINDS OF STUDIES LIKE ALL OF US? I THINK THAT VERY MUCH DEPENDS ON WHAT THE PARTICIPANTS THINK. I WILL ARGUE THAT NIH, DESPITE THE HARD WORK WE DO, WE DON'T CARRY TREATMENTS ALL THE WAY THROUGH TO THE POINT OF HAVING THEM CLINICALLY AVAILABLE. WE NEED INDUSTRY FOR THAT. IF INDUSTRY WENT AWAY TOMORROW, WE COULD MAKE A LOT OF DISCOVERIES BUT WE PROBABLY WOULDN'T CHANGE THINGS VERY MUCH IN TERMS OF TREATMENTS. THEY WILL MOVE MOST QUICKLY WHEN THEY HAVE A CHANCE WITH LEGITIMATE REASONS AND BEING OVER SEEN BY OBJECTIVE PARTIES, INCLUDING PARTICIPANTS TO SEE THE DATA. SO PROBABLY WITH APPROPRIATE CHECKS AND BALANCES THAT IS THE WAY SUCH PROGRAMS OUGHT TO GO FORWARD BUT THE CHECKS AND BALANCES ARE REALLY IMPORTANT. >> THANK YOU, DR. COLLINS AND DR. TABAK. THANK YOU FOR COMING AND VISITING WITH US AGAIN. IT'S GOOD TO SEE YOU AND I ALSO WANT TO SAY THANK YOU FOR ENCOURAGEING YOUR DEPARTMENT LEAD TOURS COME OUT TO TRIBAL COMMUNITIES ON A LOT OF THESE PROJECTS. SO TODAY'S PRESENTATION IS SORT OF REFLECTING THAT PEOPLE BEING OUT THERE IN INDIAN COUNTRY, GETTING EMERSED IN THE AREAS THAT THEY ARE WORKING IN. SO WE REALLY APPRECIATE THAT. AND ALSO I WANT TO THANK YOU FOR SUPPORTING DR. WILSON'S OFFICE AND WE SEE THE SIGNIFICANCE AND THE VALUE OF THAT OFFICE AND THE ROLE OF HIS OFFICE WORKING REALLY WELL WITH OUR COMMUNITIES. AND I WANT TO EXPRESS MY APPRECIATION TO YOU FOR THAT AS WELL. I ALSO WANT TO INTRODUCE YOU TO THESE TWO ELDERS HERE FROM NAVAJO IRB. Mrs. BEVERLY I HAVE SENTE AND DR. DAVID MCGEE. THEY DID A PRESENTATION EARLIER DEVELOPED ITS IRB AND REVIEWS RESEARCH QUITE EXTENSIVELY AND IS NOW SHARING THAT EXPERTISE WITH OTHER NATIONS AS WELL. SO, I THINK THAT IS SOMETHING THAT WE CONTINUE TO NEED THAT KIND OF SUPPORT. EVERY WAY THAT NIH CAN PROVIDE THAT SUPPORT, BUT I WANT TO BRING OUT THREE ISSUES THAT IS ON MY MIND. ONE IS THE COMMON RULE. THE COMMON RULE, WILL THERE BE A TIME FOR TRIBAL CONSULTATION ON THE COMMON RULE WHERE MAYBE WE COULD PROVIDE INPUT INTO THE WAY THAT THE COMMON RULE IS USED AS SORT OF LIKE A POLICY WITH REGARDS TO DATA SHARING? AND THEN ANOTHER ISSUE THAT I WANTED TO ASK ABOUT IS THE SINGLE IRB. WE DISCUSSED THAT SINGLE IRB HERE SEVERAL TIMES IN OUR PREVIOUS MEETINGS AND THEN AGAIN WE ARE TALKING ABOUT THIS ALL ABOUT US INITIATIVE. AGAIN, IT IS SORT OF HAS AN OVERLAY AS WE DISCUSS IT SAYS WE KNOW THERE IS ANG EXEMPTION FOR TRIBAL IRBs WHEN WE ARE TRYING TO DECIDE WHETHER A SINGLE IRB SHOULD BE APPLIED OR IF IT'S TRIBAL IRB THAT SHOULD BE TAKEN CARE OF. I GUESS MY POINT IS, COULD IT BE POSSIBLE TO STILL PROVIDE SOME TRIBAL REPRESENTATION ON SINGLE IRBs WHEN THOSE DETERMINATIONS ARE MADE? BECAUSE AS IN THE CASE OF ALL ABOUT US, WE ARE DISCUSSING IF A LOT EVEN THOUGH THEIR NATIONAL INITIATIVES AND THEY DIDN'T GO THROUGH TRIBAL IRBs. SO, BUT AT THE SAME TIME, I FEEL LIKE THERE IS SUCH A NEED FOR TRIBAL INPUT INTO THAT WHOLE INITIATIVE OF NIH. AND THEN THE THIRD POINT I WANTED TO BRING OUT WAS IN THE AREA OF DISPUTE RESOLUTION. EARLIER WHEN NAVAJO MADE THEIR PRESENTATION, THEY WERE TALKING ABOUT THE NAVAJO NATION LAW WITH REGARDS TO THE PRIVACY LAW. NAVAJO NATION PRIVACY ACT. SO WE HAVE OUR OWN NAVAJO NATION LAWS AND WE HAVE A NAVAJO NATION PRIVACY ACT. SO IN COMPARISON TO THE HIPPA ACT, THAT SORT OF GOVERNS HEALTH-RELATED ISSUES, SO THE QUESTION WAS RAISED BY MY ELDERS HERE. WHICH ONE RULES? THE TROUBLE LAW OR FEDERAL LAW? SO I THINK -- THE TRIBAL LAW OR FEDERAL LAW? IN AREAS OF DISPUTE RESOLUTION, WE APPRECIATE THAT YOU APPRECIATE THE FACT THAT TRIBAL SOVEREIGNTY IS PREDOMINANT. TRIBAL SOVEREIGNTY MEANING THAT WE HAVE OUR COURTS. WE HAVE OUR AUTHORITIES MAKE DECISIONS -- OUR COURTS THAT MAKE DECISIONS AND IF DISPUTES CAN BE SETTLED AT THAT LEVEL, WE ARE HAPPY SO, THANK YOU. >> THOSE ARE THREE VERY POSITIVE AND IMPORTANT AREAS OF OUR DISCUSSION. WITH WHAT YOU JUST SAID, THAT SOVEREIGNTY DOES RELATE. IF THERE IS A CONCERN ABOUT A PARTICULAR ISSUE AND WE RECOGNIZE THAT IN RESEARCH, AND WOULD CERTAINLY NOT WANT TO SEE ANY EXAMPLES WHERE THAT WAS NOT ADHERED TO. WITH REGARD TO THE COMMON RULE, THE FINAL RULE WAS ISSUED LAST JANUARY BUT IT HAS MANY AREAS OF POTENTIAL INTERPRETATION AS FAR AS HOW IT COULD BE APPLIED AND GIVEN CIRCUMSTANCES. AND IT PROBABLY WOULD BE A TIMELY OPPORTUNITY SINCE IT WILL NOT GO INTO EFFECT UNTIL EARLY NEXT YEAR. TO HEAR FROM TRIBES IN TERMS OF SOME OF THE AREAS WHERE THE COMMON RULE LEAVES AMBIGUITY INTENTIONALLY, I MIGHT SAY IN TERMS OF APPLICATION, I SAW IN ONE OF THE PREVIOUS SLIDES WHEN I FIRST CAME IN, THIS WHOLE QUESTION ABOUT BROAD CONSENT. THE COMMON RULE ALLOWS FOR BROAD CONSENTED BUT DOESN'T SAY IT ALWAYS HAS TO BE USED. THERE IS IT SAY LOT OF CONCERN ABOUT IT NOT BEING USED IN MANY SITUATIONS AND I UNDERSTAND IN YOUR COMMUNITY THAT WOULD BE A PARTICULAR CONCERN AND I THINK THAT IS CONSISTENT WITH WHAT THE COMMON RULE ACTUALLY SAYS BUT THIS WOULD BE A GOOD MOMENT TO BE SURE THAT WE UNDERSTAND EACH OTHER IN TERMS OF ISSUES OF THAT SORT. SIMILARLY WITH SINGLE IRBs, I THINK THE MOTIVATION BEHIND THE SINGLE IRB IT WAS PRIMARILY DRIVEN BY LARGE-SCALE CLINICAL TRIALS INVOLVING MULTIPLE INSTITUTIONS WHERE IN THE PAST EACH INSTITUTION DEMANDING TO HAVE THEIR OWN REVIEW OF THE PROTOCOL BECAUSE THEIR IRB NEEDED TO LOOK AT IT, YOU COULD EASILY USE A YEAR OR MORE GETTING THE TRIAL UNDERWAY AS EACH ONE OF THESE IRBs HAD A DIFFERENT WAY ABOUT WHETHER THE CONSENT FORM WAS WORDED PROPERLY. AND IT WAS NOT CLEAR IN THOSE SITUATIONS WHICH WERE NOT INVOLVING TRIBAL CIRCUMSTANCES, LET ME BE CLEAR ABOUT THAT. IN THE NON-TRIBAL CIRCUMSTANCES IT WASN'T CLEAR WHAT ALL THOSE ADDITIONAL IRBs WERE ADDING AS FAR AS VALUE TO PARTICIPANTS. THEY WERE CERTAINLY ADDING TO EMPLOYMENT OF LAWYERS. AND WE WEREN'T QUITE SURE THAT WAS THE GOAL WE SHOULD BE MOST INTERESTED IN SUPPORTING BUT LET ME TELL YOU FROM MY INVOLVEMENT IN THIS, OVER THE YEARS AND INTENSELY SO OVER THE LAST SIX YEARS OR SO IS THE COMMON RULE IN THE SINGLE IRB WERE BEING DISCUSSED. I DON'T THINK WE EVER HAD A DISCUSSION ABOUT SINGLE IRBs WITHOUT SAYING, BUT THERE NEEDS TO BE AN EXCEPTION. LET'S NEVER FORGET THIS ABOUT THE TRIBES. AND EVERYBODY GOT THAT. EVERYBODY UNDERSTANDS THAT. DO NOT FEAR THAT THAT IS SOMEHOW GOING TO GET GLOSSED OVER AND FORGOTTEN. WHEN IT COMES TO ALL OF US, THAT IS AN INTERESTING CHALLENGE ABOUT HOW DOES THAT PLAY OUT AND THAT IS SOMETHING WHICH DARA MAYBE TOMORROW, COULD TALK WITH YOU ABOUT. I KNOW THERE WAS -- IT WASN'T A CONSULTATION ALTHOUGH MAYBE IT WAS CALLED THAT INITIALLY AND THEN I THINK THERE WAS A RELATION THAT HAS SPECIAL MEANING TO THE WORD. IT WAS A WORKSHOP BACK IN MAY THAT WAS CONDUCTED BY THE FOLKS AT ARIZONA AND BROUGHT TOGETHER PERSPECTIVES FROM SEMPLE TRIBES AND FROM THE NIH STAFF WHO WERE MOST ENGAGED IN ALL OF US TO LISTEN TO EACH OTHER ABOUT THIS. AND I GOT A BIT OF A SUMMARY FROM THAT DISCUSSION WHICH I THOUGHT WAS QUITE HELPFUL AS A START BUT THERE IS MANY OTHER THINGS THAT NEED TO BE EXPLORED IN THAT SPACE AND LET ME SAY AGAIN, I THINK WITH ALL OF US, THERE IS SAY COMPLETE UNDERSTANDING THAT WE DO NOT GAIN ANYTHING BY RUSHING INTO THIS. IS AN OPPORTUNITY WITH A PROGRAM THAT IS NOT JUST TURNING OVER NEW DISCOVERIES TOMORROW. THIS IS SAY LONG-RANGE EFFORT. LET'S THINK CAREFULLY ABOUT FROM YOUR PERSPECTIVE WHAT KIND OF INVOLVEMENT, IF ANY, YOUR TRIBESMENT TO HAVE IN THIS. THERE IS NO ASSUMPTION ABOUT WHAT THE RIGHT ANSWER TO THAT WOULD BE. AGAIN, SOVEREIGNTY FROM OUR PERSPECTIVE IS CRITICAL AND WE WANT TO RESPECT THAT IN EVERY WAY. AND NOT RUSH INTO ANY KIND OF CONCLUSION THAT YOU HAVE NOT BASICALLY CONSTRUCTED AND ARE COMFORTABLE WITH. AND WE'LL FOLLOW THAT. >> MY NAME IS JOSH SAXON, COUNCIL MEMBER FROM THE TRIBE IN NORTHERN CALIFORNIA REPRESENTING CALIFORNIA. MY QUESTION, YOU HAD MENTIONED IT WHEN YOU FIRST CAME IN ABOUT OPIOIDS AND THE RESEARCH NEEDS SURROUNDING OPIOIDS. MY QUESTION IS, TWO PARTS. ONE, JUST IF YOU COULD COVER IN GENERAL WHAT NIH IS LOOKING AT IN TERMS OF PRIORITIZING THAT AND NUMBER 2, IS THERE ROOM FOR LOOKING AT THAT KIND OF ABILITY TO UTILIZE MULTIPLE INSTITUTES TO LOOK AT THIS EPIDEMIC? SO FOR EXAMPLE, MENTAL HEALTH AND DRUG ABUSE AND HOW THOSE TWO INTERACT WITH EACH OTHER IN TERMS OF DUAL DIAGNOSIS? SO IN INDIAN COUNTRY, YES, WE HAVE BOTH THE PAIN MANAGEMENT PROBLEM BUT WE ALSO HAVE THE MENTAL HEALTH PROBLEM AND THE SOCIAL STUFF THAT COMES INTO PLAY THERE TOO. SO I'M CURIOUS IF YOU HAVE -- HOW ARE YOU FRAMING YOUR RESEARCH NEEDS IN TERMS OF THE OPIOID EPIDEMIC? >> VERY THOUGHTFUL QUESTION AND VERY INSIGHTFUL ABOUT THIS INTERACTION BETWEEN THE OPIOID CRISIS AND MENTAL HEALTH ISSUES. YES, WE ARE VERY SENSITIVE TO THAT IN TERMS OF TRYING TO MAKE SURE THAT THIS IS NOT BEING OVER SIMPLIFIED, WHICH SOME HAVE TRIED TO DO AS A SIMPLE MATTER& OF PEOPLE WHO CAUGHT UP IN A CYCLE THAT STARTED OUT WITH SOMETHING AS BENIGN AS A PRESCRIPTION OF OXYCONTIN AND THEN ENDED UP IN AN ADDICTION AND IF YOU COULD JUST HELP THEM GET OVER IT, EVERYTHING WOULD GO BACK TO PRECISELY WHERE IT SHOULD BE. GRANTED A LOT OF THOSE WHO END UP IN THIS TERRIBLE TRAP OF ADDICTION HAVE ALSO OTHER MENTAL HEALTH ISSUES THAT ARE QUITE OVERWHELMING AND WE HAVE TO THINK HARD ABOUT HOW WE ARE AVOIDING THE OVER SIMPLE INDICATION IN BRINGING ALL OF THE TOOLS TO BEAR. AND THAT'S PART OF WHAT NIH NEEDS TO WORK ON AS FAR AS OUR CONTRIBUTIONS TO RESEARCH. WHAT ARE WE DOING? I THINK WE ARE PARTICULARLY INTERESTED IN TRYING TO COME UP WITH MORE EFFECTIVE OPTIONS FOR TREATING TWO MILLION PEOPLE WHO ARE ALREADY ADDICTED TO OPIOIDS. VERY FEW OF WHICH ARE CURRENTLY ENROLLED IN EFFECTIVE PROGRAMS TO GET THEM FREE OF THE ADDICTION. THE CHALLENGE SHEAR ENORMOUS IN TERMS OF DEMONSTRATING FOR SURE WHAT WORKS AND ALSO PARTICULARLY A CONCERN OF MINE IS THAT EVEN FOR PROGRAMS THAT HAVE EVIDENCE OF WORKING, DO THEY WORK LONG TERM OR IS THE RELAPSE RATE REALLY HIGH IF YOU FOLLOW PEOPLE LONG ENOUGH? IT LOOKS AS IF THAT IS OFTEN THE CASE. HOW LONG DO PEOPLE NEED TO BE IN TREATMENT BEFORE YOU COULD SAY IT IS SAFE TO TURN OFF ALL OF THOSE EXTRA SUPPORT SYSTEMS AND ALL WILL BE WELL? WE DON'T KNOW THE ANSWER TO THAT. AND THAT IS A RESEARCH QUESTION. WE ALSO HAVE A BIG INVESTMENT IN TRYING TO SPEED UP THE DEVELOPMENT OF ALTERNATIVES TO OPIOIDS FOR PEOPLE WHO NEED TREATMENT OF PAIN. THERE ARE 26 MILLION PEOPLE IN THIS COUNTRY WHO SUFFER DAILY FROM PAIN. WHAT WE MUST NOT DO IS SAY, TOO BAD FOR THEM. WE ARE GOING TO BASICALLY SAY OPIOIDS ARE BAD AND TAKE THEM OFF THE MARKET. THEN WHAT HAVE YOU DONE? YOU TREATED PEOPLE IN A TERRIBLY HARMFUL WAY WHO ARE SUFFERING VERY REAL QUALITY OF LIFE ISSUES WITH PAIN EVERY DAY. SO WE NEED TO COME UP WITH OTHER ALTERNATIVES THAT ARE NOT ADDICTIVE BUT ARE POTENT AND RIGHT NOW WE DON'T REALLY HAVE THEM. OPIOIDS ARE VERY POTENT. GREAT FOR AN ACUTE PAIN SITUATION. BUT FOR CHRONIC PAIN, THEY OBVIOUSLY CARRY WITH THEM ALL THE NEGATIVES WE ARE PAINFULLY FAMILIAR WITH. SO WE ARE WORKING HARD ON HOW TO SPEED THAT UP USING A LOT OF NEW NEUROSCIENCE THAT'S BEEN DISCOVERED IN THE LAST FEW YEARS ABOUT WHAT IS THE PATHWAY BY WHICH WE EXPERIENCE PAIN AND HOW COULD YOU BLOCK THAT IN A WAY THAT IS SAFE AND EFFECTIVE? AND THERE AGAIN, THAT IS ANG INTERESTING EXAMPLE WHERE WE WON'T SUCCEED IN BRINGING THOSE THINGS TO PEOPLE IN THE CLINIC WITHOUT INDUSTRY TO HELP US. SO, WE ARE ACTUALLY WORKING HARD AND THE WHITE HOUSE IS HELPING GETTING INDUSTRY TO ACCEPT THEIR ROLE IN THIS AND THEIR RESPONSIBILITY FOR FINDING OTHER SOLUTIONS. I'LL BE NEXT MONDAY WITH GOVERNOR CRISTY AND A BUNCH OF THE LEADERS OF THE PHARMACEUTICAL INDUSTRY GETTING THEIR COMMITMENT THIS IS THEIR RESPONSIBILITY TO WORK ON. I THINK THEY ARE QUITE HAPPY TO SAY IS THAT. SO, ULTIMATELY, THOUGH, AND SOMETHING WE HAVE BEEN TALKING ABOUT A LOT, HOW DO YOU COME UP WITH A STRATEGY THAT INCORPORATES DELIVERY OF WHAT THE PUBLIC NEEDS ESPECIALLY THOSE WHO ARE ALREADY SUFFERING FROM ADDICTION? AND DO RESEARCH AT THE SAME TIME? WE CAN'T SIMPLY STEP BACK AND SAY, WE ARE JUST NIH. WE DO RESEARCH AND THAT IS GOING TO BE GOOD ENOUGH. WE ARE ALSO COMMITTED TO FIGURING OUT HOW TO COME UP WITH BETTER DELIVERY SYSTEMS AND THAT MEANS WORKING WITH SAMHSA AND WORKING WITH HRSA AND WORKING WITH CMB REIMBURSEMENT AND WORKING WITH THE INDIAN HEALTH SERVICE. WE ALL HAVE TO BE IN THIS TOGETHER. FDA IS IN THAT SPACE TOO. IT HAS TO BE ALL HANDS ON DECK. THIS IS AN UNPRECEDENT THE PUBLIC HEALTH CRISIS. AND I'M SORRY, ID WILL HAVE TO RUN OFF AT THIS POINT BUT DR. TABAK -- >> DR. COLLINS, BEFORE YOU DO THAT, I DO WANT TO SHARE AND EMPHASIZE THE IMPORTANCE OF MEANINGFUL CONSULTATION WITH TRIBES AND THAT CONTINUES IN EVERY ASPECT AS WE MOVE FORWARD ON A LOT OF THESE SUBJECTS THAT WE KEEP THAT IN MIND AND 245 WE CAN'T JUST BE A BOX WE CHECK. WE HAVE TO HAVE THAT FEEDBACK AND ACTION AND SOME FOLLOW-UP. SO I THANK YOU FOR YOUR TIME AND YOU ARE EXCUSED. [ LAUGHS ] >> THANK YOU VERY MUCH. [ APPLAUSE ] #. >> OKAY DR. COLLINS IS GONE. GIVE IT TO DR. TABAK NOW. [ LAUGHS ] >> NOW YOU CAN REALLY LET IT GO. ALL RIGHT, BOBBY? >> BOBBY, THE OKLAHOMA DELEGATE. A LOT OF TRIBES HAVE ADOPTED EITHER TRIBAL OR COMMUNITY-BASED PA ANTICIPATORY RESEARCH AS A PREFERRED METHODOLOGY FOR CONDUCTING RESEARCH. IT SEEMS TO ME THE CURRENT GRANT STRUCTURE ISN'T VERY CONDUCIVE TO DEVELOPING THOSE TYPES OF RELATIONSHIPS. THEY TAKE A LONG TIME. AND IT INVOLVES A LOT OF TRUST BEFORE COMMUNITIES, TRIBAL COMMUNITIES, ARE WILLING TO PARTICIPATE IN RESEARCH. HAS THERE BEEN ANY THOUGHT TO TWEAKING THE SYSTEM OR MAKING ALLOWANCES FOR THAT GRANT STRUCTURE SO THAT RESEARCHERS AND TRIBES HAVE THAT TIME UPFRONT TO DEVELOP THOSE RELATIONSHIPS TO MAKE SURE THAT THE -- IT IS THE TRIBAL HEALTH PRIORITIES THAT ARE BEING ADDRESSED AND MAYBE NOT THE RESEARCHERS OR NIHs FOR THATTER. >> THANK YOU FOR THE QUESTION. SO, AGAIN, GOING BACK TO FRANCIS'S COMMENTS ABOUT WHEN YOU SEE AN INSTITUTE YOU HAVE SEEN ONE INSTITUTE. I THINK SOME OF THE INSTITUTES ARE FURTHER ALONG IN IS THIS TYPE OF THINKING AND OTHERS MUCH LESS SO. OTHERS USING MUCH MORE -- WHAT WE WOULD CALL TRADITIONAL APPROACHES HERE AT NIH. SO I THINK THIS IS ANOTHER REALLY IMPORTANT TOPIC TO HAVE A CONVERSATION ABOUT BECAUSE I CAN GUESS WHAT SORTS OF THINGS WE WOULD NEED TO DO TO MAKE OUR SYSTEM MORE FLEXIBLE AND MORE USER-FRIENDLY, MORE USEABLE, BUT THE TRUTH IS, I DON'T REALLY KNOW. YOU ALL DO. SO, AND SOME OF OUR INSTITUTES AND CENTERS ARE HEAVILY ENGAGED IN COMMUNITY-BASED PARTICIPATORY RESEARCH. OTHERS, IT'S NOT EVEN PART OF WHAT THEY EVEN THINK ABOUT. SO, I THINK -- AND DAVE WE ARE TRY NOT GIVE YOU TOO MANY HOMEWORK ASSIGNMENTS HERE BUT THIS IS CERTAINLY AN EXAMPLE OF SOMETHING WHERE SOME FOCUSED CONSULTATION WITH RELEVANT NIH STAFF TOGETHER WITH THE COMMITTEE, COULD REALLY HELP BECAUSE AS YOU KNOW, SOME OF THE ICs GET IT AND OTHERS ARE NOT NEARLY AS FAR ALONG. SO, I WOULD CERTAINLY ENCOURAGE THAT AS EITHER A SEPARATE TYPE OF EXERCISE OR AS PART OF A FUTURE MEETING. BUT THAT IS THE ONLY WAY WE REALLY WILL ACCOMPLISH WHAT -- AND NEEDS TO BE DONE AND WHAT WE WOULD LIKE TO SEE HAPPEN. I MEAN, IN THAT REGARD, WHAT FRANCIS WAS REFERRING TO IS A SORT OF DEMONSTRATION TYPE PROJECT THAT AT THE COMMUNITY LEVEL WHERE WITHOUT COMMUNITY BUY-IN, NOTHING GOOD IS GOING TO HAPPEN. I MEAN, SO THIS OPIOID CRISIS OF COURSE EFFECTS ALL OF YOUR NATIONS. OKAY, SO HOW DO WE ENGAGE YOU IN A CONSULTATION THAT FOCUSES ON THAT OPIOID CRISIS? AGAIN NOT TO OVER SIMPLIFY IT BECAUSE IT IS A COMPLEX MEDICAL ISSUE. BUT HOW DO WE ENGAGE YOU IN THAT CONSULTATION TO ENSURE THAT AS WE GO FORWARD, INDIAN COUNTRY IS PART OF THIS AS OPPOSED TO WELL, WE ARE NOT QUITE SURE WHAT TO DO. SO WE'LL GO TO THE USUAL APPROACHES. SO, I WOULD HOPE THAT COULD BE PART OF THIS SPECIFIC EXAMPLE OF PART OF THE GENERAL CONVERSATION THAT YOU BRING UP. >> DR. TABAK, EARLIER TODAY WE HAD DISCUSSION ON THE CLINICAL TRIALS QUESTION, WHICH WAS POSED, AND WE WANTED TO FIGURE OUT HOW OR WHAT WE NEED TO DO WITH THAT SITUATION. SO I JUST WANTED TO PUT IT ON YOUR RADAR BECAUSE WE UNDERSTAND THERE CAN BE A WAIVER TO THAT UNDER THAT LAW SO WE WANTED TO MAKE SURE THAT YOU KNEW THAT THAT WAS IN DISCUSSION BECAUSE IT'S A CURRENT SITUATION. >> THANK YOU FOR RAISING IT AGAIN AND OBVIOUSLY WE'LL HAVE THAT CONVERSATION INTERNALLY AND CIRCLE BACK. >> SO I KNOW IS THIS A HOT POTATO BUT I ALSO KNOW THIS IS A PLACE COMMITTED TO SCIENCE SO I'M GOING SAY THE C WORD, WHICH IS CLIMATE CHANGE. AND IN THINKING ABOUT HEALTH, ENVIRONMENTAL HEALTH IS SO CRITICAL. I'M THINKING ABOUT POTENTIAL RISE IN INFECTIOUS DISEASES AS A RESULT OF HURRICANE HARVEY, HURRICANE IRMA. WE KNOW THE AFTERMATH IN THOSE CASES CAN BE REALLY DEVASTATING AND MANY OF OUR COMMUNITIES, THESE STORMS ARE NOT GOING TO STOP COMING. WE KNOW THIS. THESE EVENTS WON'T STOP COMING. WE FEEL A SENSE OF RESPONSIBILITY WHETHER IT BE WITH OUR INDUSTRY, OUR SMALL BUSINESS TO HELP WITH CLEANUP TO LOOK AT SUPER FUND AND OTHER KINDS OF SITES BUT WE SEE A ROLE FOR RESEARCH AND IN SCIENCE IN HELPING GUIDE THIS. AND SO I REALIZE IT MIGHT BE SOMETHING DIFFICULT POLITICALLY TO SPEAK ABOUT BUT I'M GOING RAISE THE QUESTION ABOUT WHERE NIH SITS WITH RESPECT TO ENVIRONMENTAL HEALTH RESEARCH AND HOW OUR BODY, OUR ENTITY CAN HELP AND GUIDE SOME OF THAT WORK. >> THANK YOU FOR THE QUESTION. SO CHANGES IN CLIMATE INFLUENCE HEALTH. AND THAT IS ABSOLUTELY PART OF THE NIH MISSION. AS IF EFFECTS HUMAN HEALTH, ABSOLUTELY. WE HAVE AN INSTITUTE. THE NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES WHICH IS NOT LOCATED IN BETHESDA BUT IN NORTH CAROLINA AND THAT IS THEIR LARGE MISSION AND AS PART OF WHAT THEY DO, THEY DO HAVE SOME SUPER FUND. THEY DO DO WORKER SAFETY IN AREAS THAT HAVE BEEN STRUCK BY EITHER NATURAL OR MAN MADE DISASTER. AND IN FACT, DEPLOYED SOME INDIVIDUALS IN THIS REGARD IN THE LATEST TRAGIC CIRCUMSTANCES WITH THESE HURRICANES. BUT YOU'RE RIGHT. IT IS A EXPERIMENT OF NATURE, ONE THAT ONE NEEDS TO TAKE ADVANTAGE OF BUT IT GETS BACK DOWN TO HAVING THE DISCUSSION BEFORE THE EVENT OCCURS SO THAT YOU HAVE IN PLACE HOW YOU'RE GOING TO PROCEED BECAUSE IF YOU START THIS CONVERSATION TODAY, IN ORDER TO DO THAT PROPERLY, BY THE TIME YOU GET TO THE RESOLUTION, THERE IS OPPORTUNITY LOST. AND SO, NIHS DOES DO EXTENSIVE OUTREACH IN THIS REGARD. WE DO HAVE MECHANISMS. AND I HATE TALKING ABOUT MECHANISMS. BUT WE DO HAVE MECHANISMS THAT ALLOW FOR VERY RAPID RECEIPT, REVIEW AND FUNKING BECAUSE AGAIN OF THE TEMPORAL NATURE OF THESE EITHER NATURAL OR MAN MADE DISASTERS, AND IN FACT, IF YOU WANT, WE CAN GO TO A WEBSITE THAT DISPLAYS ALL THIS INFORMATION. BUT THERE IS DEFINITELY A RESPONSIBILITY AND THERE IS DEFINITELY A NEED FOR RESEARCH IN THESE AREAS AND IT IS THE WHOLE GAMUT. IT'S THE IMMEDIATE IMPACT. IT'S THE SAFETY TO THE PEOPLE WHO LIVE IN THE AREA. IT'S THE SAFETY OF THE WORKERS WHO ARE ENGAGED IN WHATEVER THE REHAB IS REQUIRED. AND ALL THE ABOVE. BUT TO BE OPTIMAL, YOU HAVE TO HAVE THE CONVERSATIONS UPFRONT SO YOU'RE POISED AND READY TO HIT THE SEQUENCE OF EVENTS THAT ALLOW YOU TO TAKE ADVANTAGE OF THINGS RAPIDLY. >> I WANT TO ADD TO THAT. I'M REMISS I DIDN'T MENTION ADDS PARTNERS THAT NIHS HAS A VERY DIVERSE PORTFOLIO THAT ADDRESSES AIN RESEARCH AND THEY HAVE BEEN GREAT PARTNERS IN WORKING TO DO THAT. SO I KNOW THAT THEY ARE WATCHING THE VIDEO CAST NOW AND I'M SURE THEY ARE WRITING IT DOWN AND THESE ARE PROJECTS THAT MAYBE PRESENTED TO US IN OUR NEXT MEETING. SO THANK YOU. >> JUST ONE MOMENT. WALTER, YOUR GUEST WOULD LIKE TO ADDRESS DR. TABAK. YOU WOULD HAVE TO YIELD TO HIM SO HE CAN SPEAK ON YOUR BEHALF. >> THANK YOU. >> THANK YOU.O THE GOOD DOCTOR. I WANT TO GO BACK TO WHAT DR. COLLINS SAID EARLIER REGARDING THE TRIBAL SOVEREIGNTY RULE. I THOUGHT ABOUT WHAT COULD THAT MEAN? IT COULD MEAN TRIBAL SOVEREIGNTY RULE, YOU'RE EXCUSED FROM PROVIDING DATA. IN THE MEANTIME, NIH EXPECTS TRIBES PARTICIPATE IN DATA SHARING. AND IT'S THEIR MISSION. AND SO WHERE TRIBES WILL BE GIVEN EXCEPTION, AND A LOT OF TIMES TRIBES PARTICIPATION IN THESE FEDERAL FUNDS IT'S TIED TO PARTICIPATION. AND IF TRIBES DON'T PARTICIPATE, THAT MAY CEASE OF THESE FEDERAL FUNDING SUPPORT TO TRIBES. AND SO, THEY ARE SORT OF CAUGHT IN A CATCH-22 SITUATION. AND WITH OUR TRIBE, NAVAJO NATION, IT STAYS IN THE TRIBAL LAW WE OWN THE DATA EVEN THERE, WHAT DID IT MEAN? IT SOUNDS LIKE THE TRIBE OWNS A CAR AND IF YOU DON'T USE IT IT IS SITTING THERE. EVERY ONCE IN A WHILE YOU WISH AND WAX AND PUT IT BACK IN THE GARAGE. IF YOU DON'T USE IT, IT IS USELESS. SO YOU'RE TALKING ABOUT FLEXIBILITY AND PARTNERSHIP. I'M JUST WONDERING IF A TEST CASE CAN BE DEVELOPED THROUGH ONE OF THESE GRANT PROJECTS THAT CAN PAVE THE WAY FOR OTHER TRIBES TO REPLICATE. I COULD SEE A PARTNERSHIP WHERE THE TRIBE, NIH COULD SIT DOWN AND SAY, THIS DATA, CAN IT BE SHARED? YES. CAN THIS DATA BE SHARED? NO. HOW CAN IT BE SHARED? THAT KIND OF SIT-DOWN. AND RIGHT NOW WE ARE THROWING AROUND A LOT OF WORDS, A LOT OF -- IN SOME WAY I GUESS A LOT OF RHETORIC AND WE NEED TO BE FLEXIBLE AND WORK TOGETHER AND YOU KNOW TRIBAL SOVEREIGNTY RULES. IT SEEMS LIKE -- BUT TO GO BEYOND THAT, TO ME, MAYBE A TEST CASE CAN TAKE ONE OF THE FEDERAL PROJECTS AND WALK IT ALL THE WAY THROUGH AND REALLY WORK ON THE PIECES AND THE DETAIL. >> THE FACT THAT WE'RE SITTING HERE AND HAVING THIS CONVERSATION GIVES ME HOPE THAT WE CAN DO THAT. I THINK AN EXAMPLE NEED NOT BE BUT IT IS AN EXAMPLE, IS WITH THE PROJECT THAT WE REFERRED TO AS ECHO. AND I KNOW THERE HAVE BEEN DISCUSSIONS WITH NAVAJO NATION ABOUT THESE VERY ISSUES. THESE ARE EARLY DISCUSSIONS. A LOT MORE NEEDS TO BE DONE. BUT THE APPROACH WE TOOK AND I THINK THIS WAS THE RIGHT THING TO DO AND I HOPE YOU WILL AGREE. AT THE TIME OF SUBMISSION THE APPROACH WAS WE WERE FLEXIBLE, WE'LL WORK IT OUT. WE APPRECIATE IT. WE CAN'T WORK IT ALL OUT BEFORE THE APPLICATION IS DUE. BUT THEERN COURAGEMENT TO PARTICIPATE. AND I THINK THAT WILL PROVE TO BE THE CASE. SO I THINK IF THAT IS A POSSIBLE TEST CASE, BECAUSE YOU'RE RIGHT. WHAT DO THESE WORDS REALLY MEAN? AND I THINK THAT BEING AN EXAMPLE, UNDERSTANDING THAT ALL OF THESE THINGS ARE COMPLICATED AND I DON'T KNOW IF YOU HAVE A UNIVERSAL SET OF RULES THAT EMERGE BUT THAT COULD BE A TEST CASE. AND YOU'RE RIGHT. YOU STRATIFY IT. MAY WE USE THESE DATA? YES. MAY WE USE THESE? NO. ARE THERE CIRCUMSTANCES WE MAY BE ABLE TO USE THE LATTER DATASET? MAYBE. AND THAT'S WHERE WE ARE AT. BECAUSE AT THE END OF THE DAY, AND I THINK FRANCIS ARTICULATED THIS PRETTY CLEARLY, WE WANT TO BE INCLUSIVE, NOT EXCLUSIVE. WE FEEL BY PARTICIPATING, THERE IS BENEFIT TO THE TRIBE AND BENEFIT TO THE OVERALL STUDY. AND I WOULD MUCH RATHER TAKE THE ADDITIONAL TIME, ENERGY AND EFFORT TO WORK THROUGH WHAT OUR ADMITTEDLY COMPLICATED ISSUES, TO ENSURE YOU'RE WILLINGNESS TO PARTICIPATE, AND THEN WE HAVE TO SEE HOW IT TURNS OUT. BECAUSE I CAN'T PREDICT THAT. BUT I'M CERTAINLY WILLING TO INVEST MY PERSONAL TIME, THE TIME OF OUR STAFF WHO ARE KNOWLEDGEABLE ABOUT THIS, TO SAY WE CAN REACH A RESOLUTION THAT IS ACCEPTABLE TO EVERYBODY. BECAUSE FLOW MATTER WHAT THAT FINAL RESOLUTION IS, THAT WILL BE BETTER THAN HAVING SAID NO, WE DON'T WANT YOU TO PARTICIPATE THAT OPTION IS THE WORST OPTION. OKAY? SO WILL IT BE A PERFECT SOLUTION? PROBABLY NOT. BUT I'M POSITIVE IT WILL BE BETTER THAN THE OPTION OF NO, WE DON'T WANT YOU TO PARTICIPATE. BECAUSE WE DO WANT YOUR NATIONS TO PARTICIPATE. AND DAVE, YOU KNOW BETTER THAN I, BUT ECHO MIGHT BE A GOOD PLACE TO WORK THROUGH SOME OF THIS STUFF. >> ECHO ACTUALLY HAS BEEN A REALLY GOOD TEST CASE AND IT'S BEEN BECAUSE OF THE DIRECTOR, DR. GILLMAN AND CHIEF OF STAFF, GIULIANA BLOOM, WHO HAVE BEEN REALLY RECEPTIVE TO THE PROCESS ABOUT LISTENING TO TRIBAL COMMUNITIES AND MAKING THE NECESSARY CHANGES TO THE PROGRAM TO ACCOMMODATE TO MAKE THAT PROJECT MORE INCLUSIVE AND THEREBY BEING MORE EFFECTIVE. >> SO I KNOW I CAN SPEAK FOR FRANCIS ON THIS AND I ALWAYS SAY THAT. [ LAUGHS ] JOB SECURITY, RIGHT? BUT, IN ESSENCE SINCE I KNOW I CAN SPEAK FOR FRANCIS ON THIS, WE WANT TO MAKE THIS WORK. SO WE WILL DO WHAT WE NEED TO DO TO MAKE THIS WORK BECAUSE HAVING YOU INCLUDED REGARDLESS OF HOW THAT FINALLY LOOKS, IS BETTER THAN SAYING NO WE DON'T WANT YOU HERE. I KNOW THAT. >> ACTUALLY WE ARE RIGHT AT 4:15 RIGHT NOW. SO DR. ANDERSON YOU LUCKED OUT ON THAT CONVERSATION. YOU DIDN'T HAVE TO TALK TOO MUCH. BUT THANK YOU VERY MUCH DR. TABAK FOR YOUR TIME AND BEING HERE. WE APPRECIATE IT VERY MUCH. THANK YOU. [ APPLAUSE ] ALL RIGHT. NEXT UP WE ARE GOING TO THROW IT BACK TO DR. WILSON. WE ARE DOING THE CHARTER CONVERSATION. WE ARE STILL DOING THAT. #. >> I NEED TO WALK THROUGH SOME OF THE CHANGES WE ARE PROPOSING TO THE CHARTER AND TO SEE IF THE COMMITTEE IS IN AGREEMENT WITH THIS. SO YOU ALL HAVE THE PRINT OUTS OF THE CHARTER AS IT IS WRITTEN, CURRENTLY WRITTEN IN THE BOOKS AND BINDERS. SO IF YOU COULD FLIP TO THAT PAGE OR THAT TAB. SO I THINK WE CAN WORK THROUGH THIS RATHER QUICKLY. ALL RIGHT. SO SOME OF THE PROPOSED CHANGES HERE THAT YOU CAN SEE UNDER THE COMMITTEE ACTIVITIES, NEAR STATES IT IS IMPORTANT FOR THE NIH TO BUILD RELATIONSHIPS WITHIN AIN POPULATIONS. I'M NOT QUITE SURE THAT IS WORDED QUITE CORRECTLY BECAUSE OUR GOAL IS TO LOOK AFTER THE RESEARCH INTERESTS OF THE NATIVE-AMERICAN AND ALASKA NATIVE POPULATIONS AND NOT NECESSARILY TO BUILD RELATIONSHIPS. THAT'S WHAT I'M DOING THROUGH THE OFFICE. SO EVERYBODY IS IN AGREEMENT WITH THAT, THEN WE CAN MAKE THOSE CHANGES TO INCORPORATE THE RESEARCH INTERESTS SO THE IMPORTANT FOR THE NIH TAG TO SERVE THE RESEARCH INTERESTS OF THE AMERICAN AND ALASKA NATIVE POPULATIONS BY -- BY PERFORMING THE FOLLOWING WITH RESPECT TO EACH SOVEREIGN NATIONS. THIS WAS CONFUSING STATEMENT. BECAUSE WHAT WE NEED TO PUT INTO THIS STATEMENT IS THE CONCEPT OF RESEARCH AS WELL. AND THERE ARE 567 FEDERALLY RECOGNIZED TRIBES AND IT WOULD BE VERY DIFFICULT FOR US TO CAPTURE ALL OF THAT WITHIN THIS CHARTER AND WITHIN THIS COMMITTEE. SO, OUR RECOMMENDATIONS ARE WORDING IT AS SUCH SO THAT WE ARE -- MAYBE WE RESPECT THE INTERESTS OF EACH OF THE REPRESENTATIVE AREAS WITHIN THE COMMITTEE. AND THAT'S WHAT WE HAVE HERE FOR THE COMMENT, A3. YOU SEE WHERE THAT IS AT? >> [ OFF MICROPHONE ] >> DID YOU EAT LUNCH? >> SO I GUESS WE HAD A LITTLE BIT OF A CONVERSATION ABOUT THIS ISSUE OF KIND OF ACCESS AND MAKING SURE WHETHER IT BE TO NIH, MAKING SURE THAT ALL TRIBES HAVE EQUITABLE ACCESS TO THE PROCESS AND SO THAT IS WHAT COMES UP WHEN I LOOK AT THIS AND SO, A PART OF ME THINKS WITH RESPECT FOR EACH SOVEREIGN NATION'S CULTURAL TRADITIONAL VALUES THROUGH EACH OF THE 12 REPRESENTED AREAS, POSSIBLY. BECAUSE IT DOES PUT MORE RESPONSIBILITY ON US AS REGIONAL REPRESENTATIVES SO TAKING ON SOME OF THAT BUT IT DOESN'T LOSE THE FACT THAT WE ARE, IF A TRIBE WOULD APPROACH OR WANT TO ENGAGE, THEN ABSOLUTELY THAT IS OUR RESPONSIBILITY. SO JUST ONE SUGGESTION. >> THAT SI GREAT RECOMMENDATION. AND THEN SOME OF THE NEXT CHANGES HERE IS THAT UNDER THE BULLET POINT, SERVES AS A FORM FOR TRIBES AND THE NIH TO DISCUSS AND WE SCRATCHED OUT THE PROPOSAL FOR CHANGES. WE JUST WANT -- IT'S MORE IMPORTANT FOR US TO DISCUSS NIH POLICIES, REGULATIONS AND PROCEDURES AND THE NIH RESEARCH PRIORITIES THAT AFFECT TRIBES. THAT IS A MUCH MORE ACCURATE DESCRIPTION OF WHAT WE WANT TO DO ON THE COMMITTEE. >> SO WE ALSO HAD A SIMILAR DISCUSSION ABOUT RESEARCH PRIORITIES. MY ONLY POSSIBLE SUGGESTION HERE WOULD BE TO SAY, AND RESEARCH PRIORITIES THAT AFFECT TRIBES BUT I DON'T KNOW HOW YOU WOULD RESPOND TO THAT BY TAKING NIH OUT THERE. I KNOW WE ARE AN NIH COMMISSIONED BODY. SO BUT I THINK PART OF THE DISCUSSION WAS THE RECIPROCAL BACK AND FORTH KIND OF PROCESS WHERE POSSIBLY A CASE STUDY COULD LOOK AT HOW ONE REGION IS DEVELOPING THEIR TRIBAL HEALTH RESEARCH PRIORITIES AND BRINGING THAT FORWARD TO NIH. SO THAT IS IT IN TERMS OF BOTH NIH-DRIVEN BUT ALSO TRIBALLY DRIVEN SO PERHAPS MAYBE NOT TAKING OUT NIH BUT NIH AND TRIBAL RESEARCH PRIORITIES THAT AFFECT TRIBES? >> OR MAYBE, AND/OR. IS THAT A POSSIBILITY? MY CONCERN IS THAT WE ARE TALKING ABOUT NIH POLICIES, REGULATIONS AND PROCEDURES IMMEDIATELY BEFORE THAT. SO THAT MIGHT GET LOST IN TRANSLATION IF WE TAKE OUT THE NIH COMPLETELY -- SO IF WE PUT NIH AND/OR RESEARCH PRIORITIES. >> I THINK THE WAYZ I INTERPRET THE INTENT WOULD BE NIH-FUNDED RESEARCH PROPERTIES. SO REGARDLESS OF WHERE THEY CAME FROM OR WHO PROPOSED THEM AND HOW THEY WERE NEGOTIATED INTO BECOMING A PRIORITY FOR OUR FUNDING. SO IT'S NOT OUR PRIORITIES. IT'S THE THINGS THAT WE FUND THAT CAME FROM THE ENGAGEMENT OF EVERYONE INVOLVED. >> I DIFFICULTY HEAR YOU. I'M STILL CHEWING ON WHAT DR. COLLINS OR DR. TABAK SAID ABOUT -- I THINK IT WAS DR. COLLINS ABOUT CONGRESS SETS THOSE BUDGETS IN TERMS -- AND I'M REALLY STRUGGLING TO FIGURE OUT THEN, DO WE GO TO LOBBY CONGRESS? LIKE WHERE DO WE INTERJECT SOME OF OUR RESEARCH? SO I DIFFICULTY HEAR YOU ROOTS THE FUNDING THAT DRIVES BUT I'M TRYING TO FIGURE OUT IF THERE IS SOMETHING IS THAT EMERGES FOR A TRIBAL NATION THAT IS A REAL HEALTH PRIORITY, I KNOW BACK IN THE DAY ENVIRONMENTAL HEALTH WAS A PRIORITY FOR INSTANCE AND IT WASN'T NECESSARILY AT THE TABLE HERE. HOW WOULD THAT WORK? I'M STRUGGLING WITH THIS ONE. >> SO MAYBE NIH-FUNDED RESEARCH THAT AFFECTS TRIBES. I MEAN THAT IS A BROADER BRUSH. BECAUSE THOSE MAY NOT NECESSARILY BE PRIORITIES. IT WILL BE RESEARCH THAT IT AFFECTS TRIBES BUT NOT NECESSARILY THE PRIORITIES. >> COULD WE MAY BE -- I'M SITTING HERE THINKING. I THINK WE ARE ON THE RIGHT TRACK WITH THE WORDING BUT MY CONCERN BECOMES, I WANT TO KEEP "PRIORITIES" IN THERE. SO MAYBE THERE COULD BE ANOTHER BULLET POINT THAT FOCUSES ON THE PRIORITIES. SO INSTEAD OF BLENDING THEM BOTH TOGETHER IN ONE SENTENCE, DO THE SENTENCE LIKE WE JUST TALKED ABOUT AND HAVE IT ALSO HELP SET PRIORITIES. I'M NOT DOING VERY WELL. IT'S LATE IN THE DAY. SO FEEL FREE TO EDIT THIS. JUST A SEPARATE BULLET POINT FOR PRIORITIES THAT SAYS WE WILL HELP SET PRIORITIES TOO AND WORK WITH YOU TO SET PRIORITIES, RESEARCH PRIORITIES. # I THINK THE LANGUAGE WILL WORK IF WE SEPARATE THEM OUT. >> ANY OTHER COMMENTS ON THIS BULLET POINT? >> THERE WAS ONE POSSIBLE SUGGESTION TO PULL OUT, NIH AS I SUGGESTED INITIALLY -- AND TRIBES. SO IT WOULD BE JUST, AND RESEARCH PRIORITIES. BUT THAT MAY BE TOO GENERAL FOR EVERYBODY. I WANTED TO PUT OUT SOME OTHER OPTIONS. FOR ME IT'S THE IDEA OF, WHO COULD BRING A PRIORITY I THINK IS THE QUESTION. IS IT NIH PRIORITIES OR CAN TRIBES INITIATE THAT? >> FROM A -- I GET TO BE AN ENGLISH MAJOR NOW. FROM GRAMMATICAL, IF YOU JUST LEAVE, SERVES AS A FORUM FOR TRIBES AND NIH TO DISCUSS NIH POLICIES, REGULATIONS, PROCEDURES AND RESEARCH THAT AFFECTS TRIBES, AND THEN HAVE ANOTHER ONE THAT SERVES AS A FORUM FOR TRIBES AND NIH TO DISCUSS PRIORITIES, HEALTH RESEARCH PRIORITIES. DISCUSS AND DEVELOP. BECAUSE THAT WORKS. YOU DON'T NEED NIH IN THERE TWICE FROM A GRAMMATICAL STANDPOINT BECAUSE IT WILL CAREO. SO YOU WILL BE FINE WITH THAT AND HAVE THAT SEPARATE ONE. DOES THAT MAKE SENSE? [ OFF MICROPHONE ] >> IT'S IMPORTANT ENOUGH TO BE ITS OWN BULLET POINT. >> WE WILL MAKE THAT CHANGE. AND THE PERENNIAL WILL COME BACK AGAIN NEXT MEETING. [ LAUGHS ] SO THE NEXT BULLET POINT IS TO EXPLORE THE OPPORTUNITIES -- IDENTIFYING PRIORITIES -- EXPLORING OPPORTUNITIES FOR PARTICIPATION IN OTHER NIH COMMITTEES AND/OR WORKING GROUPS AND IDENTIFYING PRIORITIES FOR AND PROVIDING ADVICE ON APPROPRIATE STRATEGIES FOR TRIBAL CONSULTATION ON NIH-RELATED ISSUES AT TRIBAL, REGIONAL AND/OR NATIONAL LEVELS. SO HOW DOES EVERYBODY -- WHAT IS YOUR TAKE ON THAT? >> YOU KNOW ME, I WANT TO KEEP CONSULTATION IN FROM THE BEGINNING. [ LAUGHS ] >> AND OKAY SO WE'LL MAKE THAT CHANGE THERE. AND THEN THE NEXT BULLET POINT IS PROVIDE RECOMMENDATIONS TO THE NIH ON CULTURAL AND TECHNICAL ISSUES REGARDING GRANTS AND CONTRACT POLICIES AND THEIR IMPACT ON TRIBES AND BRING PERTINENT ISSUES TO THE ATTENTION OF TRIBAL LEADERS. ALL RIGHT. SO WE WILL MAKE THOSE CHANGES. NOW WE ARE ON PERIODS OF SERVICE. SO TERMS ARE -- >> CAN YOU JUST GO BACK A SECOND. SOMETHING THAT ISN'T A CHANGE AND WASN'T RAISED. UNDER, COMMITTEE COMPOSITION, THERE IS NO SPECIFIED SEAT FOR URBAN INDIAN HEALTH PROGRAMS AND I DON'T KNOW IF THAT IS BECAUSE TYPICALLY THEY ARE NOT TRIBAL LEADERS WHO WERE MANAGING THE URBAN INDIAN HEALTH. SO I WONDER -- OR WAS IT JUST THAT THEY COULD BE PART OF AN AT LARGE MEMBER? OR SHOULD THEY JUST BE ON THE TECHNICAL ADVISORY COMMITTEE? >> BECAUSE OF THE SPECIAL GOVERNMENT TO GOVERNMENT RELATIONSHIP, THAT THEY HAVE TO BE ELECTED TRIBAL OFFICIALS AND CAN BE NOMINATED BY A TRIBE AND ALSO BE THE HEAD OF AN ORGANIZATION AND LEADERSHIP ROLE IN THE ORGANIZATION. FOR EXAMPLE, OUR SPECIAL PERSON OVER THERE, SHE SERVED AS A CAPACITY OF THE NATIONAL CONGRESS RESEARCH POLICY CENTER BUT SHE IS ALSO APPOINTED BY HER TRIBE. RIGHT? SO IS THAT WOULD BE THAT SPECIAL REELINGALATION OR STIPULATION TO GET THEM IN. >> SO, THAT IS HOW I UNDERSTOOD IT BUT I DIDN'T KNOW IF WE SHOULD REACH OUT TO THE URBANS AND ASK IF SOMEONE WOULD LIKE TO BE TECHNICAL ADVISOR? >> THAT IS UP TO THE PER VIEW OF THE DELEGATES. >> ALL RIGHT. I'LL LEAVE THAT. >> I HAVE ASKED ABI TO TAKE A LOOK WHAT THE WE DO AT THE URBAN HEALTH INSTITUTE. SHE IS NOT THE ONLY ONE OUT THERE. I THINK SO THIS CONVERSATION IS PRETTY CRITICAL SO I AGREE. >> SORRY. >> ALL RIGHT. SO WE ARE ORDER AT PERIODS OF SERVICE. TERMS FOR TAC ARE TWO CALENDAR YEARS. WE WANTED TO ADD INTO THIS SECTION A DESCRIPTION ABOUT THE TERMS EXPIRING AT THE END OF THE MONTH OF SEPTEMBER JUST FOR LOGISTICAL REASONS BECAUSE IF THERE IS SPRINKLED THROUGHOUT THE YEAR THAT WILL CAUSE CHAOS FOR US. IS THAT OKAY WITH EVERYBODY? ALL RIGHT. VERY GOOD. WE WILL MAKE THAT CHANGE. AND THEN VACANCY. WHEN A VACANCY OCCURS, THE EXECUTIVE SECRETARY OF TAC, WHICH IS ME, NOTIFIES THE INDIAN TRIBES IN RESPECTIVE AREAS. AS IT IS WRITTEN EAR AS WE HAVE DONE IN THE PAST, A LETTER HAS COME FROM DR. COLLINS AND I THINK THAT IS MORE EFFECTIVE. SO I THINK WE CAN MAKE THAT CHANGE AND CONTINUE OUR NORMAL PRACTICE THAT WE HAVE BEEN DOING SINCE THE COMMITTEE HAS BEEN FORMED. SO WE'LL MAKE THOSE CHANGES AS WELL. AND THEN THE NEXT ONE IS AFTER 45 DAYS, THE NIH IS NOTIFIED OF A VACANCY IN THE EVENT THE NIH RECEIVES NO NOMINATIONS, THE NIH THROUGH HHS OFFICE THROUGH EXTERNAL AFFAIRS, THIS IS AN UNUSUAL SENTENCE BECAUSE IEA MANAGES THE STACK OF SECTEES TRIBAL ADVISORY COMMITTEE AND DOESN'T MANAGE THE NIH TAC SO WE WANT TOWED MOVE THIS OUT AND PUT -- AND WE DON'T EVEN NEED THAT IN THERE. WE AS THE NIH SEEKS NEW APPOINTEES. SO WE DO THE OUTREACH OURSELVES AND RELY ON OUR TAC COMMITTEE TO ALSO COMMUNICATE THE VACANCIES AND FILL THOSE SPOTS. WE'LL MAKE THAT CHANGE AND DELETE IEA. YES? >> WILL YOU BE NOTIFYING THE TRIBAL LEADERS WHEN THE VACANCIES OCCURS OR PRIOR TO WHEN THE VACANCY OCCURS? BECAUSE THOSE PROCESSES CAN TAKE A VERY LONG TIME FOR NOMINATIONS AND SO YOU MIGHT WANT TO THINK OF A LITTLE LEAD-IN TIME BEFORE THE -- PRIOR TO THE VACANCIES OCCURRING. >> GREAT. THANK YOU, BOBBY. WHEN ALL OF THE PEOPLE WHO ARE -- THEIR TERMS ARE LAPSING AND FINISHING UP THIS SEPTEMBER, END OF SEPTEMBER, WE STARTED THE CALL FOR NOMINATIONS AT THE BEGINNING OF THIS YEAR. AND SOOTHER WE HAVE THAT VERY MUCH ON OUR RADAR. AND EVEN THEN WE HAVE BEEN GETTING LETTERS OF NOMINATIONS AS RECENTLY AS OF THIS MORNING. WE KNOW THE PROCESS. ALL RIGHT. UNDER MEETINGS HERE, THE SECOND SENTENCE AND NIH OFFICIAL SERVES AS DESIGNATED FEDERAL OFFICER. THIS PERSON DEVELOPS THE RULES OF THE ORDER DOCUMENT AND TAC AGENDAS AND YOU GUYS SET THE AGENDAS. I JUST MAKE EVERYTHING FLOW REAL NICE AND ATTEND ALL THE TAC MEETINGS. SO I THINK WE SHOULD CHANGE THAT TO THE DIRECTOR OF THE TRIBAL HEALTH RESEARCH OFFICE. IS EVERYBODY IN AGREEMENT WITH THAT? I THINK THAT IS THE WAY IT OPERATES CURRENTLY. GREAT. AND THAT IS IT. WE ARE GETTING CLOSER. WE ARE GETTING CLOSER. SO WHAT WE ARE GOING TO DO IS ONCE WE MAKE THE CHANGES, OUR NEXT STEPS WILL BE THE CHANGES NEED TO BE APPROVED BY THE OFFICE OF GENERAL COUNSEL AND ONCE THAT IS APPROVED WE CAN COME BACK AND MAKE THE LAST CHANGES THAT -- THE LAST RECOMMENDATIONS WERE MADE. SO OR THE FINAL DOCUMENT. WE WILL PRESENT THE FINAL DOCUMENT TO EVERYBODY AFTER THE OFFICE OF GENERAL COUNSEL HAS APPROVED ALL THE CHANGES WE MADE. SO HOPEFULLY NEXT TIME WE'LL HAVE A SOLIDIFIED CHARTER. WE'LL REPRESENT TAC. GREAT. >> I'M WONDERING IF YOU JUST CAN'T APPROVE THAT BY E-MAIL. IF YOU JUST DID AN E-MAIL VOTE SO IT'S NOT ON THE AGENDA FOR NEXT TIME. YOU MIGHT BE HAPPY TO HAVE THAT. I THINK WE CAN DO THAT. OR DO IT ON THE CALL. >> YES. >> WE'LL KEEP IT ON THE AGENDA AS A BUFFER. >> BECAUSE WE ARE BACK 15 MINUTES AHEAD AGAIN. SO SEE, THERE WE GO. >> YOU KNOW, YOU SEE AS ALL OF OUR MONTHLY CALLS I'M A PERSON WHO WORKS THROUGH THE AGENDA RATHER QUICKLY AND GETS TO THE POINT VERY QUICKLY. >> WE LIKE THAT. >> ALL RIGHT. >> I'M GOING TO TAKE A LEAD JUST TO DO SOME CLOSING COMMENTS AND ENCOURAGE YOU GUYS SINCE WE HAVE A LITTLE EXTRA TIME. I WAS GOING TO WRITE THEM DOWN BUT I WAS PAYING ATTENTION ON WHAT WAS GOING ON TODAY. I THINK WE HAD GOOD CONVERSATIONS AND A GOOD CAUCUS. I WILL BE DISCUSSING THAT WITH YOU AND DR. HENDERSON AT DINNER TONIGHT. SOME OF THE THINGS THAT IS WE TALKED ABOUT TODAY. AND THE WAY WE WOULD LIKE TO MOVE FORWARD, BUT AS SOMEBODY WHO WAS STARTED ON THIS COMMITTEE WHEN IT WAS BRAND NEW AND I WAS BRAND NEW TO BEING A TRIBAL LEADER, WE HAVE COME A LONG WAY FROM THAT FIRST MEETING WHEN WE REALLY DIDN'T KNOW WHAT WE WERE DOING. WE DIDN'T KNOW WHAT OUR PRIORITIES WERE GOING TO BE BUT WE HAVE BEEN ABLE TO DO THAT. AND I WANT TO GIVE DAVE AND DR. ANDERSON KUDOS FOR THE WORK THEY HAVE DONE IN TAKING THESE RANDOM THOUGHTS THAT WE HAVE AND SYNTHESIZING THEM INTO SOMETHING THAT IS WORKABLE. THE FIRST THING IT TELLS ME IS YOU'RE LISTENING TO US. SO WE REALLY APPRECIATE THAT BECAUSE THERE IS DIFFERENT KINDS OF LISTENING. THERE IS HEARING WHAT SOMEBODY SAYS AND THERE IS UNDERSTANDING IT AND MOVING ON IT AND YOU GUYS ARE DOING THAT. SO, I APPRECIATE THAT. I THINK WE TALKED ABOUT A LOT OF ISSUES AND THINGS AND I THINK WE ARE GOING TO HAVE A PRETTY ROBUST AGENDA FOR THE NEXT IN-PERSON MEETING AS WE MOVE FORWARD. ALTHOUGH I THINK WE GET PLACES WHEN WE CAUCUS. WE SAY OKAY, HERE ARE THE BLANKS WE NEED TO FILL IN. HERE ARE SOME OF THE THINGS WE SEE WE NEED TO FILL IN. AND SO, I THINK WE ARE DOING WHAT WE NEED TO BE DOING AND I THINK WE ARE DOING A PRETTY GOOD JOB OF IT CONSIDERING HOW BUSY ALL OF US ARE WITH OTHER THINGS AND COMMITMENTS THAT WE HAVE. NOW THAT YOU'RE BACK, I'LL TURN IT OVER TO YOU PRESIDENT KILLS BACK IF YOU HAVE ANY COMMENTS YOU LIKE. >> I AM ALSO IMPRESSED OF THE WAY WE ARE MOVING. WE HAD A LITTLE BIT OF A HURDLE LAST YEAR BUT I THINK WE GOT OVER IT AND ACTUALLY STRENGTH TREND COMMITTEE AND STRENGTHENED OUR RESOLVE TO REALLY EMPOWER THIS COMMITTEE. THE OTHER HHS COMMITTEES ARE MOVING JUST AS FAST AS WE ARE BUT I THINK WE ARE MAKING REALLY LARGE STRIDES AND PROBABLY GETTING NOTICED A LOT MORE FOR THE WORK WE ARE DOING BECAUSE IT IS MORE TECHNICAL AND WE ARE DEALING WITH SCIENTISTS AND PH.D.s. AND I THINK THAT IS SOMETHING THAT WE CAN TAKE -- I KNOW CHESTER AND I, WE ARE STILL ON THE STACK, AND THAT'S ONE THING WE CAN BRING UP AT THAT LEVEL BECAUSE I KNOW THEY ARE LOOKING DOWN AT THE OTHER ADVISORY COMMITTEES TO BETTER ENGAGE IN COMMUNICATION AND MUTUAL GOALS AND STRATEGIES, ESPECIALLY WITH THE CURRENT ADMINISTRATION. SO, WITH THAT, I WILL BE GONE TOMORROW AND I WISH YOU ALL THE BEST IN YOUR DISCUSSION AND I ASKED WALTER IF WE COULD REQUEST ONE OF THE ELDERS VINCETE, TO GIVE US CLOSING PRAYER.