>> WELCOME
TO THE 2022 NIH TRIBAL ADVISORY
COMMITTEE MEETING.
MY NAME IS DR. DAVID WILSON AND
I AM THEY DIRECTOR THE NIH
TRIBAL HEALTH RESEARCH OFFICE
AND I WOULD LIKE TO CALL THIS
MEETING TO ORDER.
OUR FIRST ORDER OF BUSINESS WILL
BE THE ROLL CALL.
KENDRA?
>>THANK YOU DR. WILSON WE WILL
DO OUR ROLE CALL STARTING WITH
THE IHS AREAS AND MOVING INTO
NATIONAL AT-LARGE MEMBERS SO IF
YOU WILL JUST ACKNOWLEDGE FOR
THOSE WHO ARE PRESENT FOR THE
MEETING WE WILL START OUT WITH
ALASKA.
>>WELL, IT'S GOOD MORNING HERE
IN ALASKA.
DENISE DILLARD.
>>THANK YOU DR. DILLARD.
>>ALBUQUERQUE AREA.
>>[INDISCERNIBLE].
BILLINGS AREA?
GREAT PLAINS?
LOOKS LIKE WOO HAVE DR. MOUSSO
ON THE LINE.
AND HER TECHNICAL ADVISOR.
NASHVILLE AREA?
>>THIS IS DR. JOCK NASHVILLE
AREA.
>>THANK YOU DR. JOCK.
WE HAVE CHRISTIE'S TECHNICAL
ADVISOR, NAVAHO?
>>GOOD MORNING THIS IS
DR. [INDISCERNIBLE] WITH NAVAHO
NATION.
>>THANK YOU DOCTOR.
>>OKLAHOMA AREA.
>>GOOD AFTERNOON BOBBY
SAUNKEAH, OKLAHOMA DELEGATE.
>>THANK YOU BOBBY.
COURT LAND AREA?
LOOKS LIKE WE HAVE TECHNICAL
ADVISOR REPRESENTATION FROM
CANDAS HERMINEZ.
>>TUCSON AREA?
>>GOOD MORNING [INDISCERNIBLE]
PRESENT.
>>THANK YOU COUNCIL WOMAN.
>>DR. SOLOMON PRESENT.
>>THANK YOU DR. SOLMAN.
NATIONAL AT-LARGE DEBBIE
DANFORTH.
I DON'T THINK SHE'S BEEN ABLE TO
JOIN US YET BUT WE DO HAVE OUR
TECHNICAL ADVISOR JESSICA DEAN
ON THE LINE AND AT-LARGE MEMBER
DR. DONNA GILBREATH.
I BELIEVE SHE IS AVAILABLE.
WE DO HAVE HER TECHNICAL ADVISOR
TIM THOMAS ON THE LINE.
SO WE'LL GO WITH NIH
INTRODUCTIONS.
WE WANT TO START WITH
DR. EISINGER.
>>HI, THIS IS DR. EI SINGER.
>>THIS IS DR. DAVID WITH THE
RESEARCH OFFICE.
>>JULIA DEBLOOM DEPUTY DIRECTOR
OF THE NIH TRIBAL HEALTH OFFICE.
>>SURE.
>>GOOD AFTERNOON, SARAH HULL,
SENIOR ADVISOR AND BIOETHICS
TRIBAL ETHICS OFFICE ON DETAIL.
>>MOES?
>>MIGHT HAVE HAD ISSUES, SO
THAT'S OUR TEAM RIGHT THERE,
KENDRA.
GREAT, THANK YOU.
IT DOESN'T LOOK LIKE WE'VE HAD
ANY AKIGZAL TECH MEMBERS JOIN US
YET SO THIS MEETING CURRENTLY IS
FOR INFORMATIONAL PURPOSES, WE
ARE SHORT 1 MEMBER FOR A QUORUM
AT THIS TIME SO AS WE JOIN OTHER
SAYS ON, WE CAN MAKE AN
ANNOUNCEMENT IF WE MAKE A
QUORUM.
>>GREAT.
THANK YOU KENDRA, AT THIS TIME,
I WOULD LIKE TO ACKNOWLEDGE
DR. BOB EISINGER WHO'S THE
ACTING DIRECTOR FOR THE DIVISION
OF ACCORD NATION AND PLATINUM
STRATEGIC INITTIAIVE ITS TO
SHARE A FEW WORDS SO
DR. EISINGER.
>>THANK YOU AND GOOD AFTERNOON
AND GOOD EVENING EVERYONE AND
WELCOME TO THE FALL MEETING OF
THE NIH TRIBAL ADVISORY
COMMITTEE.
IT'S MY PLEASURE TO PARTICIPATE
IN TODAY'S PROCEEDINGS.
AS MOST OF YOU KNOW, THE NIH'S
MISSION IS TO SEEK FUNDMENTAL
KNOWLEDGE ABOUT THE NATURE, AND
BEHAVIOR OF LIVING SYSTEMS AND
THE APPLICATION OF THAT
KNOWLEDGE TO ENHANCE HEALTH,
LENGTHEN LIFE AND REDUCE ILLNESS
AND DISABILITY.
NIH SUPPORTS BASIC CLINICAL AND
TRANSLATIONAL BIOMEDICAL AND
BEHAVIORIAL AND SOCIAL SCIENCE
RESEARCH INCLUDING RESEARCH ON
TRIBAL HEALTH.
IN THE DIVISION OF PROGRAM
COORDINATION PLANNING AND
STRATEGIC INITIATIVES WHICH
INCLUDES THE TRIBAL RESEARCH
OFFICE OR THRO, WE PLAN AND
COORDINATE THE TRANSNIH
INITIATIVES AND RESEARCH.
WE SUPPORT AGENCY WIDE PORTFOLIO
ANALYSIS AND IDENTIFY EMERGING
SCIENTIFIC OPPORTUNITIES AND
RESEARCH PRIORITIES.
AS AN ADVISORY COMMITTEE, THE
TAC'S ROLE IS TO PROVIDE A FORUM
FOR MEETINGS BETWEEN ELECTED
TRIBAL OFFICIALS AND NIH
OFFICIALS TO EXCHANGE
INFORMATION ABOUT NIH RESEARCH
AND TRAINING POLICIES, PROGRAMS,
PRIORITIES, AND OTHER ACTIVITIES
THAT AFFECT AI/AN POPULATIONS.
AS WE COME TO THE END OF THIS
CALENDAR YEAR ISSUES I WOULD
LIKE TO THANK EACH OF YOU FOR
YOUR PARTICIPATIONOT TAC.
WE APPRECIATE THE TIME AND YOUR
WILLINGNESS TO HELP NIH IMPROVE
THE HEALTH OF TRIBAL COMMUNITIES
THROUGH BIOMEDICAL RESEARCH.
WE LOOK FORWARD TO ANOTHER
PRODUCTIVE NEW YEAR AS WE START
2023.
THANK YOU.
>>THANK YOU DR. EISINGER.
I HAVE 1 MORE ITEM OF BUSINESS
TO TAKE CARE OF BEFORE WE HAVE
THE DISCUSSION WITH DR. TABAK.
SO THE NIH TRIBAL ADVISORY
COMMITTEE OPERATES IN,A CORDANCE
WITH THE FEDERAL ADVISORY
COMMITTEE ACT ALSO KNOWN AS FACA
WHICH GOVERNS HOW FEDERAL
AGENCIES MANAGE AND USE ADVISORY
COMMITTEES TO OBTAIN PUBLIC
INPUT AND UNDER THE STATUTORY
EXEMPT TO FA CA FOUND IN THE
UNMONITORIDATES REFORM ACT OF
1985, THE NIH TAC IS OPERATES AS
A NONFACA, AND THE EXEMPTION
APPLIES TO THE TAC ONLY WHEN A 2
PART TEST IS MET.
THE FIRST PART OF THIS 2 PART
TEST IS THAT MEETINGS ARE HELD
EXCLUSIVELY BETWEEN FEDERAL
OFFICIALS AND ELECTED OFFICERS
OF TRIBAL GOVERNMENTS OR
DESIGNATED EMPLOYEES WITH THE
AUTHORITY TO ACT ON THEIR BEHALF
WHILE ACTING IN THEIR OFFICIAL
CAPACITIES AND SECOND SUCH
MEETINGS ARE SOLELY FOR THE
PURPOSE OF EXCHANGE OF
INFORMATION OR ADVICE RELATING
TO THE MANAGEMENT OR
IMPLEMENTATION OF FEDERAL
PROGRAMS, ESTABLISHED PURSUANT
TO THE PUBLIC LAW THAT
EXPLICITEY OR INHERENTLY SHARE
LAWS.
THE FACA IS AN ATTEMPT TO
FACILITATE COMMUNICATION BETWEEN
FEDERAL GOVERNMENTS AND TRIBAL
GOVERNMENTS TO PROMOTE
INTERGOVERNMENTAL CONSULTATION
SO WITH THE FACT THAT NIH MUST
ADHERE TO THE GUIDANCE BY THE
OFFICE OF MANAGEMENT AND BUDGET,
ALSO KNOWN AS OMB, AS WELL AS
HOW THESE NACA COMMITTEES
OPERATE.
PLEASE NOTE THESE VOTES ARE
FOLLOWING AND ATHAT THE NIH
DELEGATES CAN SEEK TIME TO THEIR
ALTERNATES TO SPEAK, THEY CAN'T
SEEK TIME TO MEMBER ADVISORS OR
MEMBERS OF THE PUBLIC.
TECHNICAL ADVISORS ARE NOT PART
OF THE GROUP, AND THEY ONLY
SERVE AS THEM ON THE COUNCIL.
THE FEDERAL EMPLOYEES MAY
ATTEND, SPEAK AND PARTICIPATE IN
UMR FACA MEETINGS AS NEEDED AND
AS APPROPRIATE.
AND MEMBERS OF THE PUBLIC MAY
ATTEND THE MEETING BUT ARE ONLY
ABLE TO OBSERVE AND MAY NOT
PARTICIPATE IN ANY WAY.
AND IF THE NIH FEDERAL OR TRIBAL
ADVISORY COMMITTEE DOES NOT
COMPLY WITH FACA, ALL COMMITTEE
FINDINGS, CONCLUSIONS,
RECOMMENDATIONS MAY BE
INVALIDATED AND THE NIH MAY BE
BAR FRIDAY USING ANY OF THE
COMMITTEE RECOMMENDATIONS AND
THAT COULD JEOP ARD ICE PAST AND
FUTURE ACTIONS OF THE TAC.
THUS WE RESPECTFULLY ASK YOU TO
FOLLOW THE GUIDELINES AND
MAINTAIN THE STATUS AND
INTEGRITY OF THE NIH TRIBAL
ADVISORY COMMITTEE AND THANK YOU
VERY MUCH FOR THAT FINAL FORM OF
BUSINESS AND NOW, I WOULD LIKE
TO HAND IT OFF TO AND INTRODUCE
OUR DIRECTOR OF THE NIH
DR. LARRY TABA K.
>>THANK YOU VERY MUCH, DAVE.
I APPRECIATE THE OPPORTUNITY TO
SEE EVERYBODY TODAY.
THOSE OF YOU WHO I'VE NOT YET
MET, I'M PRIVILEGED TO BE
PERFORMING THE DUTIES OF THE
DIRECTOR OF NIH.
THIS ODD PHRASEOLOGY IS BECAUSE
OF NOTHING CALLED THE VACANCIES
ACT WHICH SAYS THAT WHEN YOU
HAVE A POSITION THAT IS
PRESIDENTIAL APPOINTEE THAT HAS
TO BE CONFIRMED BY THE UNITED
STATES SENATE, CAN YOU HAVE AN
ACTING DIRECTOR ONLY FOR 220
DAYS.
WE BLEW BY THAT IN JULY.
AND SO WHAT THEY DO IS THEY
CHANGE YOUR TITLE TO PERFORMING
THE DUTIES OF AND PRESUMABLY
THEY ALSO CHANGE SOME OF MY
DUTIES BUT I HAVEN'T FOUND ANY
DIFFERENCE YET, SO HERE I AM AND
NEXT WEEK WILL BE 1 YEAR SINCE I
TOOK OVER IN THIS ROLE.
BUT IT'S A ROLE THAT I AM TRULY
PRIVILEGED TO BE SERVING.
SO AS WE HAVE DONE MOST OF THE
MEETINGS WE'VE CONDUCTED WITH
THE TRIBAL ADVISORY EXITEE, MOST
OF THE TIME WILL BE FOR OPEN
DISCUSSION BUT I DID WANT TO
FRAME A FEW THINGS, I DID WANT
TO DEVOTE A LITTLE BIT OF THE
TIME JUST TO GIVE YOU AN
OVERVIEW OF SOME OF THE
IMPORTANT WORK THAT WE HAVE BEEN
INVOLVED WITH IN PARTNERSHIP
WITH OUR TRIBAL PARTNERS, AND
THIS INCLUDES TRIBAL
CONSULTATIONS, DATA USE ISSUES,
DATA SCIENCE ISSUES, AND THEN
FINALLY, JUST OUTLINE SOME OF
THE NEW RESOURCES THAT THE NIH
TRIBAL HEALTH RESEARCH OFFICE
HAS AVAILABLE.
SO WITH REGARD TO THE FIRST
ITEM, NIH TRIBAL CONSULTATIONS,
WE HAVE TRIED TO MAKE RESPECT
FOR TRIBAL SOVEREIGNTY 1 OF THE
HIGHEST PRIORITIES AT NIH.
WE HAVE MADE A COMMITMENT TO DO
THIS IN A VARIETY OF WAYS BUT
OBVIOUSLY AMONG THEM IS
ADHERENCE THROUGH TRIBAL
CONSULTATION.
IN MARCH OF THIS YEAR, WE
IMPLEMENTED OUR TRIBAL
CONSULTATION POLICY WHICH WAS
DESIGNED TO COMPLEMENT THE
EXISTING TRIBAL CONSULTATION
POLICY AT THE HHS.
THIS IS A FOUNDATIONAL DOCUMENT.
IT LAYS OUT WHAT WE HOPE ARE
CLEAR AND CONSISTENT PROCESSES
FOR ALL OF NIH TO PARTICIPATE IN
MEANINGFUL TRIBAL CONSULTATION.
IN 2021, WE HAD 4 TRIBAL
CONSULTATIONS.
ONE ON OUR NATIVE AMERICAN
RESEARCH CENTERS FOR HELP, THE
NARCH PROGRAM FOR EVALUATION.
THE SECOND WAS ABOUT THE NIH
TRIBAL CONSULTATION POLICY.
THE THIRD WAS ABOUT THE RAPID
ACCELERATION OF DIAGNOSTICS OR
RAD X TRIBAL DATA REPOSITORY AND
THE FOURTH WAS ABOUT THE
NATIONAL COVID COHORT
COLLABORATIVE OR N3 C.
THIS YEAR IN 2022, WE HAVE HELD
3 VERY IMPORTANT CONSULTATIONS
ON THE FOLLOWING INITIATIVES.
THE FIRST ON THE HELPING TO END
ADDICTION LONG-TERM INITIATIVE,
THE NIH HEAL INITIATIVE.
THE SECOND IS THE NIH STRATEGIC
PLAN FOR TRIBAL HEALTH RESEARCH
WHICH IS DESIGNED TO LAY OUT
PRIORITIES FROM THE YEARS 2024,
THROUGH 2028.
AND THEN FINALLY, THE NIH
IMPROVE PROGRAM WHICH STANDS FOR
INITIATIVE FOR MATERNAL HEALTH
CENTERS OF EXCELLENCE.
NOW ALL MATERIALS RELATED TO
THESE CONSULTATIONS INCLUDING
THE FINAL REPORTS CAN BE FOUND
ON THE TRIBAL HEALTH RESEARCH
OFFICE WEBSITE UNDER THE TRIBAL
CONSULTATIONS TAB.
FOR EACH OF THESE CONSULTATIONS,
TRIBAL LEADER INPUT HAS BEEN
CRITICAL.
TREMENDOUSLY INSIGHTFUL AND
VERY, VERY HELPFUL AS NIH
DESIGNS CUTTING EDGE PROGRAM
IMPROVEMENTS AND INNOVATIVE
PILOT PROGRAMS.
SO WE THANK YOU ALL AND HOPE
THAT YOU WILL CONTINUE TO
PARTICIPATE IN THIS PROCESS AS
WE MOVE AHEAD.
WE KNOW THAT THESE CONSULTATIONS
ARE VERY TIME CONSUMING FOR
VERY, VERY BUSY PEOPLE.
BUT YET WITHOUT YOUR
PARTICIPATION WE REALLY CAN'T
ACHIEVE THE GOALS THAT WE ARE
SETTING OUT TO DO.
SO I REALLY DO THANK EACH OF
YOU.
THE SECOND PROGRAM I WOULD LIKE
TO DRAW YOUR ATTENTION TO ARE A
SERIES OF DATA SCIENCE,
ARTIFICIAL INTELLIGENCE AND
MACHINE LEARNING EFFORTS.
WE CONTINUE TO HEAR FROM YOUR
COMMUNITIES THAT IT IS IMPORTANT
FOR YOU TO MAKE DATA DRIVEN
DECISIONS REGARDING ANY NUMBER
OF ASPECTS OF COMMUNITY HEALTH
THAT YOU ARE FACING.
AND SO TOWARD THAT END, THE
TRIBAL HEALTH RESEARCH OFFICE
AND THE OFFICE OF DATA SCIENCE
STRATEGY ARE COLLABORATING WITH
THE AMERICAN INDIAN HIRE
EDUCATION CONSORTIUM TO PILOT A
DATA SCIENCE CURRICULUM IN
TRIBAL COLLEGES.
THIS COLLABORATIVE GROUP IS
EXPLORING INNOVATIVE WAYS TO
EXPAND THIS EFFORT THROUGH OTHER
UMBRELLA PROGRAMS WE HAVE AT NIH
WITH TRIBAL NATIONS INCLUDING
THE NARCH PROGRAM.
AND LATER TODAY, YOU WILL BE
HEARING ABOUT ANOTHER DATA
SCIENCE EFFORT CALLED BRIDGE TO
AI, IT REPRESENTS ANOTHER
COLLABORATIVE EFFORT BETWEEN THE
OFFICE OF DATA SCIENCE STRATEGY
AND THE TRIBAL HEALTH RESEARCH
OFFICE WITH THE TRIBAL HEALTH
RESEARCH OFFICE PROVIDING THE
NECESSARY GUIDANCE ON HOW BEST
TO EFFECTIVELY INCLUDE TRIBAL
COMMUNITIES TO THESE EFFORTS.
WE HOPE YOU WILL ALL AGREE THAT
THESE ARE EFFORTS THAT ARE WELL
WORTH THE TIME AND ENERGY AS
THIS REALLY REPRESENTS A VERY
IMPORTANT FUTURE GROWTH AREA FOR
ALL OF MEDICAL RESEARCH AND WE
OF COURSE WANT YOU THERE AS OUR
PARTNERS THERE, RIGHT IN THE
MIDDLE OF THE MIX.
NOW THE ADVANCED TRAINING AND
ARTIFICIAL INTELLIGENCE FOR
PRECISION NUTRITION SCIENCE
RESEARCH, INSTITUTIONAL RESEARCH
TRAINING PROGRAMS IS A NEW
INITIATIVE.
THERE WAS A FUNDING OPPORTUNITY
AND ANNOUNCEMENT THAT WILL
INVITE APPLICATIONS FOR NEW
INSTITUTIONAL TRAINING PROGRAMS
AT EITHER THE PREDOCTORAL AND/OR
POST DOCTORAL LEVEL, FOCUSING ON
INTEGRATING PRECISION NUTRITION,
ARTIFICIAL INTELLIGENCE, MACHINE
LEARNING, SYSTEMS BIOLOGY,
SYSTEMS SCIENCE, BIG DATA AND
COMPUTATIONAL ANALYTICS AND THE
REASON THAT WE ARE MAKING THESE
INVESTMENTS IN OUR TRAINEE
POPULATION IS THAT WE WANT TO
BUILD A WORKFORCE THAT IS GOING
TO BE ABLE TO USE THE GROWING
DATA RESOURCES TO ADDRESS VERY
COMPLEX AREAS IN NUTRITION
SCIENCE GOING FORWARD.
AND AGAIN, IT'S REALLY OUR HOPE
THAT SOME OF YOUR ORGANIZATIONS,
SOME OF YOUR COMMUNITIES WILL
WISH TO PARTICIPATE IN THESE.
IT'S PART OF A LARGER ISSUE OF
THE CURRENT ADMINISTRATION ON
HUNGER, NUTRITION AND HEALTH AND
OF THE LINK TO THE FUNDING
OPPORTUNITY REQUEST FOR
APPLICATIONS CAN BE FOUND ON THE
TRIBAL HEALTH RESEARCH OFFICE
WEBSITE.
NEXT I WOULD LIKE TO TURN MY
ATTENTION TO THE RESPONSIBLE
MANAGEMENT AND SHARING OF
AMERICAN INDIAN AND ALASKA
NATIVE PARTICIPANT DATA.
THIS IS A TOPIC THAT WE HAVE
DISCUSSED ON A NUMBER OF
OCCASIONS BECAUSE OF ITS
IMPORTANCE.
AND JUST TO REITERATE, WE
APPRECIATE HOW VITALLY
SIGNIFICANT IT IS FOR US TO
RESPONSIBLY MANAGE IN HOW WE
SHARE AND MANAGE DATA FROM
AMERICAN INDIAN AND ALASKA
NATIVE PARTICIPANTS.
BACK IN 2020 IN OCTOBER NIH
ISSUED THE NIH POLICY FOR DATA
MANAGEMENT WHICH TAKES EFFECT
THIS COMING JANUARY IN 2023, THE
OFFICE OF SCIENCE POLICY HAS
FINALIZED SUPPLEMENTAL
INFORMATION RELATED TO
RESPONSIBLE MANAGEMENT AND
SHARING OF AMERICAN INDIAN AND
ALASKA NATIVE PARTICIPANT DATA
AND AS I'M SURE YOU REMEMBER,
THIS DOCUMENT WAS CO DEVELOPED
WITH THE TRAVEL ADVISORY
COMMITTEE AND WAS DISTRIBUTED TO
TRIBAL LEADERS FOR THEIR FINAL
COMMENT IN EARLY 2022.
THE OFFICE OF SCIENCE POLICY
RELEASED THE FINAL PUBLICATION
IN SEPTEMBER OF 2022.
THEY HAVE SINCE RIGHT AFTERWARDS
HELD A WEBINAR PUBLICLY TO HELP
INFORM THE BROADER RESEARCH
COMMUNITY ABOUT THESE
RESPONSIBILITIES AND TO ANSWER
QUESTIONS ABOUT THE NEW POLICY.
THE DOCUMENT INCLUDES
CONSIDERATIONS AND BEST
PRACTICES FOR NIH SPONSORED
RESEARCHERS WORKING WITH TRIBAL
NATIONS AND BY WAY OF EXAMPLE,
EMPHASIZING THE IMPORTANCE OF
RESPECT FOR TRIBAL SOVEREIGNTY,
THE NEED TO DO PROACTIVE
ENGAGEMENT WITH TRIBAL NATIONS,
THE VALUE AND NECESSITY OF
ESTABLISHING MUTUAL GOALS FOR
DATA MANAGE AM AND SHARING AND
THEN FINALLY TO ADDRESS A DATA
MANAGEMENT AND SHARING PLANS IN
THE INFORMED CONSENT PROCESS.
THE NOTICE OF ALL OF THIS AGAIN
CAN BE FOUND ON THE TRIBAL
HEALTH RESEARCH OFFICE WEBSITE.
NOW I'D LIKE TO MENTION DATA
COORDINATION AND WE'VE ALL DEALT
WITH THIS EVERY SINGLE DAY, WE
ARE FACED WITH A LARGER VOLUME
OF DATA GROWING LARGER AND
LARGER OVER TIME AND RESEARCHERS
HAVE RESPONDED IN MANY INSTANCES
BY ESTABLISHING DATA HUBS TO
COLLECT AND SHARE DATA AND MORE
AND MORE SO CALLED BIG DATA
PROGRAMS ARE BEING DEVELOPED
GLOBALLY.
WHAT HAS BECOME ABSOLUTELY CLEAR
IS THAT NIH AND TRIBAL NATIONS
NEED TO WORK TOGETHER IN
COLLABORATION TO DEVELOP
STRATEGIES THAT GUIDE HOW SO
CALLED BIG DATA PROGRAMS CAN
BEST WORK WITH TRIBAL NATIONS.
OUR LEADERSHIP HAS BEGUN
DISCUSSIONS ABOUT DEVELOPING A
BEST PRACTICES DOCUMENT, THE
TRIBAL DAT AND NIH REPOSITORIES
AND WE ARE HOPE EMPLOY THAT BY
WORKING WITH BOTH THE TRIBAL
ADVISORY COMMITTEE AND THE
TRIBAL PROCESSES THAT WE WILL BE
ABLE TO FINALIZE THIS GUIDANCE
AND CALENDAR YEAR 2023.
JUST A FEW OTHER ITEMS BEFORE WE
OPEN IT UP FOR COMMENT AND
DISCUSSION.
WE HAVE JUST CONCLUDED THE 2022
NATIONAL NATIVE AMERICAN
HERITAGE MONTH.
NIH LOOKS FORWARD EVERY YEAR TO
CELEBRATING THE OCCASION REALLY
AS A UNIQUE OPPORTUNITY TO
HIGHLIGHT AMERICAN INDIAN AND
ALASKA NATIVE CULTURE, INGENUITY
AND MANY CONTRIBUTIONS TO
BIOMEDICAL RESEARCH.
THIS NOVEMBER WE COMMEMORATED
NATIVE AMERICAN HERITAGE MONTH
WITH AN ANNUAL GUEST LECTURE, IT
WAS HELDOT 16 GHTS OF NOVEMBER,
THAT FOCUSED ON COMMUNITY-DRIVEN
ENVIRONMENT AT HEALTH RESEARCH
THAT IS TAKING PLACE IN ALASKA.
I HOPE YOU HAD A CHANCE TO VIEW
THIS EVENT IN REALTIME BUT IF
YOU'RE SCHEDULE DID NOT PERMIT
THAT, CAN YOU VISIT THE TRIBAL
HEALTH RESEARCH ON THIS WEBSITE.
THE EVENT WAS RECORDED AND YOU
CAN LOOK AT IT AT YOUR LEISURE.
FINALLY, I JUST WANT TO
HIGHLIGHT A FEW NEW RESOURCES
FROM THE NIH'S TRIBAL HEALTH
RESEARCH OFFICE.
THE FIRST IS HONORING HEALTH
NEWS LETTER, BOTH IN THE SUMMER
AND FALL OF 2022, HONORING
HEALTH ENEWS LETTERS, INCLUDED
IMPORTANT INFORMATION FOR
AMERICAN INDIANS AND ALASKA
NATIVES.
THIS NEWS LETTER'S BEEN AROUND
FOR A WHILE BUT IT'S NOW CURATED
BY THE TRIBAL HEALTH RESEARCH
OFFICE AND IT WAS RECENTLY
EXPANDED TO INCLUDE NIH HEALTH
TOPICS, RESOURCES AND EVENTS AND
TRAINING AND FUNDING
OPPORTUNITIES.
SO IT MAY BE A VERY
CONVENIENT
WAY FOR TRIBAL LEADERS OR STAFF
MEMBERS TO BE UP TO DATE ON WHAT
IS AVAILABLE.
AND YOU CAN SUBSCRIBE TO THIS
NEWS LETTER THROUGH THE TRIBAL
HEALTH RESEARCH OFFICE WEBSITE.
EARLY EARLY THIS YEAR, THE
TRIBAL RESEARCH HEALTH OFFICE
JOINED LINKEDin TO HELP
ESTABLISH AN ONLINE COMMUNITY OF
PROFESSIONALS AND STUDENTS
WORKING ON OR INTERESTED IN
TRIBAL HEALTH RESEARCH, DO MEAS
TAKE THE OPPORTUNITY FOR THOSE
OF WHO YOU PARTICIPATE IN
LINKEDin TO LOOK UP THE TRIBAL
HEALTH RESEARCH OFFICE ON THIS
FORUM AND FOLLOW IT FOR
INFORMATION ABOUT NIH,
BIOMEDICAL RESEARCH, FUNDING,
EMPLOYMENT AND INTERNSHIP,
OPPORTUNITIES AND EVENTS AND
OTHER ACTIVITIES.
SO JUST TO CLOSE, WE ARE
CONSTANTLY TRYING TO IMPROVE OUR
COMMUNICATION AND COLLABORATION
WITH TRIBAL NATIONS.
YOU KNOW I APPRECIATE--IT'S A
CONTINUED WORK IN PROGRESS.
I'VE REALLY ONLY COVERED A SMALL
SAMPLING OF THE OVERALL EFFORTS
OF OUR AGENCY IN OUR ONGOING
COMMITMENT TO WORKING ON
RESEARCH AND TRAINING
OPPORTUNITIES FOR TRIBAL
NATIONS.
OUR GOAL IS TO SUPPORT THE KIND
OF BIOMEDICAL AND SOCIAL SCIENCE
RESEARCH THAT FINDS SOLUTIONS
THAT REDUCES THE HEALTH
DISPARITIES AND INIQUITIES THAT
EXIST AND THAT ULTIMATELY
IMPROVES HEALTH WHICH OF COURSE
GETS US BETTER PREPARED FOR
ANYTHING THAT THE FUTURE HOLDS
FOR US.
SO I WANT TO THANK YOU ALL FOR
THE OPPORTUNITY FOR ME TO SHARE
THESE UPDATES.
I LOOK FORWARD TO THE DISCUSSION
THAT WILL FOLLOW AND LET ME TURN
IT BACK TO THE CHAIR PERSON OF
THE COMMITTEE.
THANK YOU.
>>GOOD MORNING AND GOOD
AFTERNOON, EVERYONE.
THANK YOU DR. TABAK, THIS IS
[INDISCERNIBLE] WITH THE IT, AC,
THANK YOU SO MUCH FOR JOINING US
THIS MORNING.
I KNOW YOUR TIME IS VALUABLE AND
WE ALL APPRECIATE THAT YOU ARE
ABLE TO SPEND THIS TIME WITH US.
AND I REALLY DO APPRECIATE THE
KEY POINTS THAT YOU BROUGHT UP
BECAUSE THESE ARE REALLY THE KEY
AREAS THAT WE WANTED TO TALK TO
YOU ABOUT SO YOU'RE RIGHT ON
POINT.
SO WE'RE ALL ON THE SAME WAVE
LENGTH HERE ESPECIALLY STARTING
WITH THE TRIBAL CONSULTATION, WE
WERE JUST TALKING ABOUT THAT
TODAY, THIS MORNING AND ABOUT
THE PRESIDENT'S TRIBAL SUMMIT
THAT HE HAD LAST WEEK TO INSURE
THAT YOU KNOW WE CONTINUE OUR
TRIBAL CONSULTATION, BEING THAT
NIH IS SO BIG, SO MANY CENTERS
AND SO MANY INSTITUTIONS AND SO
MUCH GOING ON THAT WE NEED TO
CONTINUE TO HAVE THESE TRIBAL
CONSULTATIONS AND INSURE THAT
ALL OF THESE DIFFERENT AREAS OF
RESEARCH THAT ARE HAPPENING AND
THAT WE CONTINUE WITH OUR TRIBAL
CONSULTATION AND HAVE THE TAC
INVOLVED AND USE OUR ADVISORY
CAPACITY AS BEST AS YOU CAN AND
I THINK WITH THE NEXT 2 DAYS,
THAT IS 1 OF THE THINGS THAT
WE'RE GOING TO BE DOING IS
WORKING OUT HOW WE CAN BEST USE
OUR ROLE AS THE TAC TO BE ABLE
TO HELP AND TO BE ABLE TO
COMMUNICATE LIKE YOU TALKED
ABOUT EARLIER.
THERE'S A LOT HAPPENING AND WE
ALSO WANT TO BE ABLE TO SHARE
OUR INFORMATION WITH OUR
COMMUNITIES, WITH OUR TRIBES,
WITH EVERYONE WHO WE'RE WORKING
WITH SO THAT THIS INFORMATION
GETS OUT INCLUDING THE TRIBAL
CONSULTATION, SO I APPRECIATE
THAT YOU BROUGHT THAT UP WITH
CONSULTATION BECAUSE IT'S VERY
IMPORTANT TO ALL THE TRIBES
WITHIN THE STATES AND WITHIN THE
ALASKA REGION INDIAN COUNTRY.
>>WELL, THANK YOU.
YOU KNOW, WE HAVE LEARNED THAT
THESE SESSIONS ARE BOTH
ESSENTIAL BUT ALSO INVALUABLE
BECAUSE THEY SERVE AS IMPORTANT
GUIDES FOR US SO THAT WE MAKE
SURE WE REMAIN IN ALIGNMENT.
YOU ARE QUITE CORRECT.
YOU KNOW NIH IS A LARGE
ORGANIZATION AND ONLY THE
CONGRESS OF THE UNITED STATES
COULD DEVELOP SUCH AN
ORGANIZATION.
YOU KNOW WE'RE COMPLETELY
DECENTRALIZED AND SO, SOMETIMES
WE ARE NOT AS SYNCHRONIZED AS WE
SHOULD BE AND THAT'S ON US.
I MEAN, WE HAVE TO DO BETTER
OBVIOUSLY, BUT I THINK WITH YOUR
CONTINUED GUIDANCE AND INPUT, WE
WILL CONTINUE TO IMPROVE HOW WE
GO ABOUT THIS AND IN SO DOING,
EVERYBODY WILL BENEFIT.
SO WE CERTAINLY LOOK FORWARD TO
CONTINUING TO WORK WITH THE
TRIBAL ADVISORY COMMITTEE AS
WELL AS THE INDIVIDUAL TRIBAL
NATIONS OF COURSE.
>>THANK YOU AND WE DO HAVE SOME
QUESTIONS FROM OUR TAC
MEMBERSHIP.
I THINK DR. JOCK?
>>THANKS FOR THIS INFO SESSION
AND GIVING US--STARTING US OFF
WITH THIS OVERVIEW.
AND I WANT TO CONTINUE ON THIS
LINE OF CONSULTATION AND I
WANTED TO ASK, WHAT IS THE NIH
DOING TO MAKE RESEARCH THAT IS
FUNDED THROUGH THE NIH AND THE
RESEARCHERS, THE RESEARCH TEAM,
TEAMS THAT ARE FUNDED THROUGH
THE NIH AWARE OF THE
CONSULTATION REQUIREMENTS THAT
ARE REALLY UNIQUE TO TRIBAL
HEALTH RESEARCH.
YEAH, SO WE APPROACH THIS IN
MULTIPLE WAYS, PERHAPS THE MOST
SIGNIFICANT IS THAT WE DISCUSS
THIS AT OUR INSTITUTE AND CENTER
DIRECTOR MEETINGS WHICH ARE
ATTENDED BY THE INSTITUTES
CENTER, DIRECTORS OF THE 27
DIFFERENT ORGANIZATIONS THAT
MAKE UP THE FEDERATED SYSTEM
THAT WE KNOW IS NIH.
AND SURPRISINGLY, DESPITE ALL OF
THE EFFORTS, THIS COMES AS NEWS
TO SOME OF OUR NEWER CENTER
DIRECTORS, SO FORTUNATELY WE OUR
TRIBAL HEALTH RESEARCH OFFICE
HAS BEEN INSTRUMENTAL IN WORKING
VERY CLOSELY WITH ALL OF OUR
INSTITUTES AND CENTERS, BUT
PARTICULARLY CARE TO THOSE WHO
ARE NOW BEING LED BY NEWER
MEMBERS OF OUR ORGANIZATION.
WE'VE ALSO THROUGH THE TRIBAL
HEALTH RESEARCH OFFICE WORK AT A
STAFF LEVEL TO INSURE THAT THE
PEOPLE WHO ARE IMPLEMENTING
THINGS ON A DAY-TO-DAY BASIS ARE
AWARE.
AND OF COURSE, WE ALSO, NIH AS
AN ORGANIZATION PARTICIPATES IN
THE SECRETARY TRIBAL ADVISORY
COUNCIL, MEETINGS AND PROCESS
AND I'VE BEEN PRIVILEGED TO BE
THE NIH LIAISON TO THIS TAC FOR
MANY YEARS NOW SO I'M ABLE TO
BRING BACK THAT INFORMATION AS
WELL TO BOTH STAFF AND
LEADERSHIP.
BUT YOU KNOW DR. WILSON YOU MAY
HAVE ADDITIONAL THINGS YOU MAY
WANT TO POINT TO BEYOND WHAT I
HAVE OUTLINED.
>>YEAH, THANK YOU DR. TABAK.
AND WE DO THIS, YOU COVERED IT
VERY WELL.
WE PARTICIPATE IN AS MANY
COMMITTEES AND COORDINATING ROLE
AS POSSIBLE.
AND THIS IS IN THE DEVELOPMENT
OF DIFFERENT NEW INITIATIVES AND
WE HAVE LOTS OF INFORMATIONAL
MEETINGS WITH VARIOUS PROGRAM
COMMITTEES, ACROSS THE NIH, SO
IT'S AN ONGOING PROCESS, AND
IT'S SOMETHING THAT WE HAVE TO
CONTINUE TO DO TO CONTINUE TO
EDUCATE, YOU KNOW THOSE WHO ARE
NEW TO THE NIH, AND THOSE WHO
HAVEN'T HAD THE OPPORTUNITY TO
ENGAGE WITH TRIBAL COMMUNITIES
AS OF YET.
SO THERE'S GROWING INTEREST AND
YOU WILL HEAR MORE ABOUT THIS IN
OUR PRESENTATIONS TOMORROW ABOUT
WANTING TO SUPPORT TRIBAL HEALTH
RESEARCH.
OUR GOAL IS TO MAKE SURE IT'S
ALL DONE PROPERTILY AND
ETHICALLY AND WITH CONSULTATION
AS THE BACK DROP OF EVERYTHING
THAT WE DO MOVING FORWARD.
THANKS.
>>THANK YOU, DAVE.
>>SORRY ABOUT THAT, DR. JOCK,
DID YOU HAVE ANY FOLLOW UP TO
THAT?
DID
--THANKS.
ONE OF THE ISSUES CAN BE THAT
WHEN RESEARCH IS SUBMITTED, THE
INITIAL GRANT IS SUBMITTED THAT
THERE ISN'T AS MUCH
UNDERSTANDING EVEN AT THE GRANT
IN THE INITIAL SUBMISSION STAGE,
SO I WAS WONDERING IF YOU COULD
TALK MORE ABOUT WHAT IS DONE AT
THAT STAGE TO TRY TO PREVENT
THIS LACK OF CONSULTATION WHICH
CREATES MANY PROBLEMS AND IS
ETHICAL CONCERN FOR TRIBAL
COMMUNITIES TO NOT BE CONSULTED.
I WAS WONDERING IF YOU COULD
SPEAK MORE TO WHAT IS DONE AT
THAT STAGE.
>>YEAH, SO THIS IS STILL A WORK
IN PROGRESS.
I HAVE TO--YOU KNOW ADMIT THAT.
WE DO DISCUSS THIS WITH THE
FOLKS WHO ARE RESPONSIBLE FOR
RUNNING THE CENTER FOR
SCIENTIFIC REVIEW, CSR, WHICH
REVIEWS ABOUT 70% OF ALL OUR
APPLICATIONS.
BUT AS YOU LIKELY KNOW, THE
REMAINING 30% ARE REVIEWED BY
THE INDIVIDUAL INSTITUTES AND
CENTERS AND UNFORTUNATELY THERE
IS SOMEONE--SOME HETEROGENERATED
AITY IN THEIR UNDERSTANDING.
BECAUSE FRANKLY WE SHOULD BE
CATCHING AT THE VARIOUS EARLY
INCEPTION, WHEN WE FIRST LOOK AT
THE GRANT APPLICATION, YOU KNOW
SORT OF LIKE AS A CHECK LIST,
YOU KNOW IS THERE EVIDENCE OF
BONA FIDE TRIBAL CONSULTATION OR
NOT?
AND THIS IS SOMETHING THAT WE
NEED TO YOU KNOW CONTINUE TO
WORK TOWARDS THAT FINAL GOAL.
AGAIN, I THINK FOR OUR CENTER
FOR SCIENTIFIC REVIEW, WHERE WE
HAVE, YOU KNOW SORT OF A
CONSOLIDATED APPROACH, WE DO A
BETTER JOB BUT THE INDIVIDUAL
INSTITUTES AND CENTERS, THERE IS
SOME UNEVENNESS.
AGAIN, IF I MAY ASK DR. WILSON,
IF THERE ARE ANY APPROACHES THAT
WE WOULD LIKE TO ADD TO WHAT
I'VE OUTLINED?
NYES, THANK YOU DR. TABAK.
SO WE ARE DEVELOPING A SERIES OF
RESOURCES THAT WE'RE HOPING
ACADEMIC INSTITUTIONS WILL REPLY
HEAVILY ON IN TERMS OF USING
THOSE DOCUMENTS FOR EDUCATING
THEIR INVESTIGATORS.
THAT'S 1 OF THE CHALLENGES THAT
IS THAT WE DON'T HAVE OVERSIGHT
OVER THE INSTITUTION SO I SHOULD
SAY AS MUCH OVERSIGHT AS WE
WOULD LIKE IN TERMS OF HOW
INVESTIGATORS, ENGAGE WITH
TRIBAL COMMUNITIES, SO WE WANT
TO USE THESE DOCUMENTS AS
RESOURCES SO THAT THE
INSTITUTIONS CAN EDUCATE THEIR
INVESTIGATORS ON THE APPROPRIATE
COURSES OF ACTION IN TERMS OF
MEETING WITH TRIBES EARLY ON TO
WORK THROUGH INTELLECTUAL
PROPERTY AGREEMENTS THAT MIGHT
COME ABOUT AS A RESULT OF THE
RESEARCH THAT'S BEING CONDUCTED
OR SUPPORTED BUT ALSO IN TERMS
OF DATA SHARING AND DATA
MANAGEMENT AGREEMENTS, THERE'S
ALSO MAKING SURE THAT THE--THE
RESEARCHERS GO THROUGH THE
APPROPRIATE CHANNELS IN TERMS OF
TRIBAL IRBs APPROVALS AND
REVIEWS, YEARLY MEETINGS WITH
IRBs AND UPDATES.
WHATEVER THE AGREEMENTS OR
STIPULATIONS FOR ARE THE TRIBES
WE WANT THOSE TO BE RECOGNIZED
SO WE HAVE THE BEST PRACTICES
DOCUMENT THAT'S BEEN OUT, I
THINK THAT I'VE MENTIONED THAT
WE ARE IN THE FINAL STAGES AND
IT'S--INTERNAL REVIEW, ABOUT
BEST PRACTICES OF HOW DO WE
INCLUDE URBAN INDIAN POPULATIONS
IN BIOMEDICAL RESEARCH.
THAT'S GOING TO BE A REALLY
IMPORTANT DOCUMENT AS WELL
BECAUSE THAT COVERS A LOT OF
THINGS THAT HAVE BEEN MENTIONED
HERE THAT AREN'T SO CLEARLY
DEFINED WHEN WE WORK WITH TRIBAL
COMMUNITIES THAT HAVE LAND BASED
JURISDICTIONS SO WE'RE ARE
DEVELOPING AND CONTINUING TO
DEVELOP RESOURCES AND WE LOOK
FORWARD TO PARTNERING WITH THE
TAC IF THERE ARE ADDITIONAL
RESOURCES THAT WE SHOULD BE
THINKING ABOUT THAT WOULD HELP
PRESERVE OR RECOGNIZE TRIBAL
SOVEREIGNTY IN BIOMEDICAL
RESEARCH.
>>IF I MAY ADD 1 ADDITIONAL
THING.
THANK YOU, DAVE, A VERY GOOD
REVIEW.
ONE ADDITIONAL THING,
PERIODICALLY WE ASK THAT TRIBAL
ADVISORY COMMITTEE FOR THEIR
NOMINEES FOR REVIEW PANELS, AND
FORTUNATELY, I MEAN THE GOOD
NEWS IS, THE SCIENTIFIC
WORKFORCE IN INDIAN COUNTRY HAS
CONTINUED TO GROW AND SO IT'S
VERY PORL THAT THERE ARE NOW
ADDITIONAL PERSONS WITHIN YOUR
COMMUNITIES THAT WOULD BE
INTERESTED IN SOME FORM OF
REVIEW SERVICE AND SO IF YOU
COULD LET US KNOW WHO THOSE
INDIVIDUALS ARE BECAUSE THAT
WOULD BE ANOTHER IMPORTANT
APPROACH, IS IF WE HAVE
INDIVIDUALS WHO ARE CULTURALLY
AWARE AND SENSITIVE ON REVIEW
PANELS.
THEY COULD RAISE THEIR HAND AND
SAY WAIT A MINUTE, THIS HAS NOT
BEEN CONSIDERED APPROPRIATELY
AND SO FORTH.
SO IF WE COULD ADD THAT IN
ADDITION TO THE THINGS THAT
WE'RE DOING AT OUR END, THAT
WOULD BE GREAT.
THANK YOU.
>>THANK YOU.
WE HAVE ANOTHER QUESTION FROM
OUR DELEGATE MR. SAUNKEAH.
DID I SAY IT RIGHT.
>>YOU WERE CLOSE.
SAUNKEAH.
>>THANK YOU COUNCIL WOMAN,
APPRECIATE IT.
DR. TABAK, THANK YOU FOR JOINING
US AGAIN, APPRECIATE YOUR TIME.
IN YOUR OPENING REMARKS YOU
TALKED ABOUT HOW THE BIG DATA
PROGRAMS ARE EXPANDING AND I
THINK WE'RE CLEARLY ON THIS
COMMITTEE AWARE OF THAT AND THE
FACT THAT IT SEEMED TO ME AT
LEAST TO BE ACCELERATING MORE
QUICKLY THAN, YOU KNOW THE
TRIBAL DATA SOVEREIGNTYY EFFORTS
CAN KEEP UP WITH, RIGHT?
BECAUSE EVERY MEETING IT SEEMS
LIKE WE'RE INTRODUCED TO A NEW
PROGRAM OF SOME SORT, A NEW
REPOSITORY AND IT'S HARD TO KEEP
UP WITH AND THEN YOU ALSO
MENTIONED IN YOUR REMARKS ABOUT
DATA HUBS, YOU KNOW THAT PEOPLE
WERE ESTABLISHING DATA HUBS
WHICH TO ME IS EVEN
DECENTRALIZING AND MAKING IT
MORE DIFFICULT RIGHT, FOR US TO
MONITOR TRIBAL DATA SOVEREIGNTYY
ISSUES AND SO, YOU REFERENCED A
GUIDANCE DOCUMENTS, BEST
PRACTICE GUIDANCE DOCUMENTS THAT
WILL BE COMING OUT IN HOPEFULLY
2024.
COULD YOU ELABORATE MORE ON THAT
AND LET US KNOW WHAT TYPE OF
INPUT THE TAC WILL HAVE OR WHAT
OPPORTUNITIES THERE WILL BE FOR
TRIBES TO BE INVOLVED IN THAT
PROCESS.
>>NO, THANK YOU.
SO THE DOCUMENT WILL SPEAK TO
THE VARIOUS THINGS THAT YOU JUST
OUTLINED.
THE PROLIFERATION OF THE USE OF
BIG DATA AND YOU'RE RIGHT, I
MEAN YOUR OBSERVATION AND
COMPLETELY CORRECT.
IT'S JUST ACCELERATING AND IT'S
REALLY HARD TO KEEP UP WITH
EVERYTHING AND SO WE WOULD
ENVISION HAVING THE TRIBAL
GUIDANCE COMMITTEE THAT PROVIDES
GUIDANCE TO US AS WE FORMULATE
THIS AS WELL AS INDIVIDUAL
TRIBAL CONSULTATIONS.
YOU KNOW WE'RE AIMING FOR 24 BUT
IN BETWEEN THERE'S A LOT THAT'S
GOING TO BE GOING ON.
SO WE'RE IN EFFECT TRYING TO DO
THIS IN REALTIME IF YOU WILL,
IT'S CRITICALLY IMPORTANT
BECAUSE AND AGAIN, I DON'T MEAN
TO SOUND LIKE I'M LECTURING
BECAUSE YOU ALL KNOW THIS, ON
THE 1 HAND, WE VERY MUCH WANT
PARTICIPATION FROM AMERICAN
INDIAN AND ALASKA NATIVES
BECAUSE WE THINK THIS IS A WAY
OF IMPROVING HEALTH.
BUT ON THE OTHER HAND, WE DON'T
WANT TO COMPROMISE THE INTEGRITY
OF THE SOVEREIGNTY OF THE
INDIVIDUAL TRIBAL NATIONS.
SO WE HAVE TO FIND THAT RIGHT
BALANCE AND FRANKLY, YOU KNOW
THE TRIBAL ADVISORY COMMITTEE IS
1 OF OUR BEST HOPES OF
NAVIGATING THIS.
AGAIN, DAVE, IF THERE ARE MORE
SPECIFIC THINGS THAT YOU WOULD
LIKE TO DRAW TO THE ATTENTION OF
THE TAC AT THIS POINT IN TIME,
PLEASE DO SO.
>>WELL, I WOULD JUST LIKE TO
BRIEFLY SAY THAT THE
RECOMMENDATIONS WILL BE
DEVELOPED BY LEADERS BY
INSTITUTE DIRECTORS ACROSS THE
AGENCY, SO, THEY HAVE A VERY
GOOD VIEW OF HOW MANY OF THESE
BIG DATA REPOSITORIES ARE
DESIGNED AND THEY WILL DO THEM
IN A VERY GENERAL WAY SO THAT
THE TAC CAN HELP US IDENTIFY
WHERE OTHER CRITICAL POINTS WERE
THAT WE NEED TO BE FOCUSING ON
TO MAINTAIN DATA INTEGRITY, DATA
SECURITY, TO MAKE SURE THAT THE
TRIBES ACTUALLY HAVE ACCESS TO
THE DATA AND SO THEY HAVE MOST
BENEFIT FROM THE DATA IN THESE,
IN THE LARGE GROWING DATA
RESEARCH PROGRAMS.
BUT IT'S REALLY EXCITING AND
WE'RE LOOKING FORWARD.
IT HASN'T INITIALLY KICKED OFF
YET. THIS IS JUST SOMETHING
THAT'S BEGUN, WE'VE IDENTIFIED
THE ISSUE AND PROBLEM AND WE
WANT TO MAKE SURE TO RAISE THIS
TO YOUR ATTENTION TO KNOW THAT
THIS IS GOING TO BE ON THE WAY
SOON.
>>THANK YOU, DAVID.
THIS IS REALLY IMPORTANT BECAUSE
DATA SCIENCE HAS ALREADY BECOME
CENTRAL TO BIOMEDICAL RESEARCH
AND IT'S GOING TO BECOME EVEN
MORE SO INTO THE FUTURE AND I
THINK THIS IS A GROWTH AREA FOR
SCIENCE AND BIOMEDICAL RESEARCH
AND ELGT THAT YOU WANT TO GET
TRIBAL NATIONS TO THE EXTENT
POSSIBLE IN ON THIS SORT OF
GROUND FLOOR SO THAT THEY'RE
ABLE TO GROW WITH US BOTH IN
TERMS OF WORKFORCE AND
IMPLEMENTATION AND SO FORTH.
SO I'M VERY, YOU KNOW, EXCITED
BY THE VARIOUS INITIATIVES THAT
WE'VE ALREADY LAUNCHED AND
OBVIOUSLY LOOK FORWARD TO
WORKING WITH EVERYBODY GOING
FORWARD ON THIS.
>>THANK YOU.
I KNOW WE HAVE A FOLLOW UP
QUESTION FROM DR. JOCK RELATED
TO THIS SO DR. JOCK AND THEN I
BELIEVE DR. DILLARD HAS ANOTHER
QUESTION.
SO DR. JOCK?
DID EMPLOY.
>>THANKS AND JUST A REAL QUICK
QUESTION ABOUT YOUR--IF YOU
COULD EXPAND ON THE NIH'S POLICY
AND YOUR PERSPECTIVE ON THE ROLE
OF TRIBAL IRBs IN REVIEWING
RESEARCH AND SUPPORTING ETHICAL
AND RIGOROUS RESEARCH IN INDIAN
COUNTRY.
>>THE IRBs ARE ESSENTIAL.
WE WORK THROUGH THE IRBs.
YOU KNOW WE HAVE IN SOME
INSTANCES BEEN CULTURE CONFIRMED
ASSESSESFUL IN REACHING WHAT WE
THINK ARE MUTUALLY BENEFICIAL
APPROACHES TO DATA RELEASE.
IN OTHER INITANCES, WE'VE
CREATED I GUESS THE TERMINOLOGY
WOULD BE AN ENCLAVE TO ALLOW THE
DATA TO BE COMPUTED UPON ONLY BY
INDIVIDUALS THAT THE TRIBAL
NATION IS COMFORTABLE WITH DOING
THIS AND I THINK ALL DIFFERENT
TYPES OF MODELS WILL ULTIMATELY
BE REQUIRED BUT AGAIN, YOU KNOW
THE IRB HAS TO PLAY A ROLE
BECAUSE PRESUMABLY THAT'S WHERE
THE EXPERTISE IS FOR THE TRIBAL
NATION.
BUT IT DOES SOMETIMES TAKE
CONVERSATION AND DISCUSSION TO
MEET, YOU KNOW THE RIGHT
BALANCE, I SEE YOU'VE TURNED
YOUR CAMERA ON, SO, DR. WILSON,
PLEASE GO AHEAD.
>>THANK YOU DR. TABAK, WILL BE
HEARING MORE ABOUT THIS IN A
PRESENTATION BY THE OFFICE OF
SCIENCE POLICY BUT I WANTED TO
GIVE OUR BIOETHICIST A CHANCE TO
RESPOND AND SHE CAN SHARE HER
COMMENTS, THANKS.
>>THANK YOU.
YES, FIRST I WANTED TO SAY I
ENDORSE FULLY WHAT DR. TABAK
SAID, IT'S VERY IMPORTANT TO
DEFER TO TRIBAL IRBs AND OTHER
TRIBAL RESEARCH GOVERNANCE
STRUCTURES AND YOU WILL HEAR
MORE FROM ME LATER THIS
AFTERNOON ABOUT CONCRETE STEPS
WE'RE TAKING AND CHECK LISTS AND
MECHANISMS THAT WE'RE USING TO
MAKE SURE THAT FOR EXAMPLE WHEN
A NONNATIVE IRB S&P INITIALLY
DESIGNED TO REVIEW, THAT
INVOLVES TRIBAL RESEARCH, WE
PAUSE AND MAKE SURE ALL THE
NECESSARY REVIEWS HAVE TAKEN
PLACE BEFORE WE PROCEED WITH OUR
PARALLEL REVIEW, ALSO REALLY
TRYING TO GET OUT AHEAD OF THAT
AND EDUCATE THE RESEARCH
COMMUNITY ABOUT THE NEED TO
START THESE CONVERSATIONS
EARLIER AS HAS ALREADY BEEN
MENTIONED SO THAT WE'RE NOT
PLAYING CATCH UP AT THE POINT
THAT A RESEARCHER SUBMITS
SOMETHING TO THE IRB BUT THAT
WE'RE ACTUALLY INTERVENING MUCH
EARLIER ON TO INSURE THAT EENCH
THE RESEARCH QUESTIONS WE'RE
SELECTING IS SOMETHING THAT'S
DONE COLLABORATIVELY AND THAT
INPUT HAS ALREADY BEEN GIVEN
INTO THE DESIGN AND THE RESEARCH
AND CONSENT PROCESS BUT I WILL
ELABORATE ON THAT LATER THIS
AFTERNOON AND HOPEFULLY AND
HAPPY TO TAKE QUESTIONS, I GUESS
NOW OR THEN.
>>GREAT.
THANK YOU FOR THOSE
ELABORATIONS:
>>THANK YOU.
NEXT WE HAVE DR. DILLARD.
>>THANK YOU.
IT'S GOOD TO SEE YOU DR. TABAK,
FEELS LIKE IT'S BEEN A WHILE.
SO I HAVE A QUESTION OR A
COMMENT THAT'S SORT OF RELATED
TO DATA SOVEREIGNTY BUT IS MAYBE
NOT DIRECTLY RELATED TO DATA BUT
KIND OF A BIGGER PICTURE
QUESTION IS KIND OF WHAT ARE THE
EFFORTS UNDERWAY AT NIH TO
ADDRESS SOME OF THE
INSTITUTIONALIZED BIASES, RACISM
THAT OCCURS AT DIFFERENT LEVELS
IN KIND OF WHAT ARE THE EFFORTS
IN THAT REGARD?
>>YEAH, SO, YOU KNOW EARLIER
DR. COLLINS ISSUED A STATEMENT
TALKING ABOUT HOW STRUCTURAL
RACISM WITHIN THE NIH PROCESSES
HAVE REALLY SERVED AS A BARRIER
TO INSURING TRUE DIVERSITY, TRUE
EQUITY, TRUE INCLUSIVITY AND WE
ARE CONTINUING TO WORK THROUGH
THESE SORT OF HARD WIRED
BARRIERS THAT WE'VE DONE TO
OURSELVES AND OBVIOUSLY THIS
ALSO RELATES TO INVESTIGATORS
AND TRAINEES FROM INDIAN
COUNTRY.
WE CONTINUE TO STRIVE TO GET A
BETTER DIVERSIFIED REVIEW PANEL
WE CONTINUE TO ENCOURAGE
IONIZATIONSITUTE --INSTITUTE
CENTERS AND TO CONSIDER
DIVERSITY IN THOUGHT, IN THE
BROADEST TERMS, RACE, ETHNICITY,
GENDER, LOCATION.
WE REALLY DO WANT TO LEARN FROM
THE BEST MINDS EVERYWHERE,
REGARDLESS OF WHERE THEY ARE.
WE HAVE REFINED SOME OF OUR
REQUIREMENTS FOR SOME OF THE
FELLOWSHIP PROGRAMS WHICH
HERETOFORE REQUIRED STANDARDIZED
EXAMS AS PART OF THE APPLICATION
PROCESS AND YOU KNOW VOLUMES
HAVE BEEN WRITTEN ABOUT HOW
STANDARDIZED EXAMS BASICALLY,
YOU KNOW GIVE TREMENDOUS
ADVANTAGE TO THOSE WHO MORE
WEALTHY OR WHO, YOU KNOW, COME
FROM YOU KNOW ENVIRONMENTS WHERE
THEY'RE JUST MORE RESOURCES.
WE HAVE TRIED TO--TO REALLY
EDUCATE OUR STAFF IN THE
APPROPRIATE WAYS TO ENGAGE WITH
AND WORK WITH ALL MEMBERS OF THE
BIOMEDICAL RESEARCH COMMUNITY.
AND WE'RE TRYING VERY HARD
TO--RECRUIT A MORE DIVERSE
WORKFORCE HERE AT NIH BECAUSE
OBVIOUSLY I CAN LEARN ABOUT
ISSUES RELATED TO AMERICAN
INDIAN AND ALASKA NATIVES BUT
IT'S NOT A LIVED EXPERIENCE
WHEREAS IF YOU HAVE SOMEBODY
WITH THAT LIVED EXPERIENCE,
THEY'RE MUCH MORE CULTURALLY
COMPETENT THAN I AM AND SO, IT
BEHOOVES US TO HAVE PEOPLE WITH
THAT EXPERTISE AND THAT
EXPERIENCE AS MEMBERS OF OUR
TEAM TO INSURE THAT WE LOOK AT
THINGS IN A FAIRER MORE EVENT
MANNER.
THOSE ARE SOME OF THE THINGS
WE'RE DOING.
DAVE IS CUEING ME AS HE POPS UP,
SO PLEASE DAVE, PLEASE CONTINUE.
>>THANKS DR. TABAK, 1 OF THE
IMPORTANT THINGS THAT WE'VE ALSO
REALLY BEEN FOCUSING ON IS
ENCOURAGING OUR IC PARTNERS TO
INCLUDE MORE LANGUAGE THAT IS
RECEPTIVE TO INCLUDING CULTURAL
APPROACHES TO CREATING
INTERVENTIONS AND ALSO INCLUDING
TRIBAL COMMUNITIES TO WANT TO
PARTICIPATE IN SOME OF THE
STUDIES THAT WE'VE BEEN
SUPPORTING.
SO THAT'S--THAT COMPONENT OF IT
IS ALSO EQUALLY IMPORTANT SO
THAT THERE'S MORE AWARENESS
ACROSS THE SCIENTIFIC ENDEAVOR
OR COMMUNITY ABOUT THE
IMPORTANCE OF INCLUDING CULTURE
AND TRADITION INTO THE STUDY'S
DESIGN AND WITH THAT COMES
EVERYTHING ELSE ABOUT COMMUNITY
ENGAGEMENT, CO COLLABORATIONS
AND ALL OF THESE THINGS THAT
WE'RE ALSO ENCOURAGING OUR IC
PARTNERS TO SUPPORT MOVING
FORWARD.
>>AND IF I MAY, JUST 1 FINAL
POINT, WE HAVE BEEN INCREASINGLY
IDENTIFYING FUNDING
OPPORTUNITIES THAT ARE TAILORED
FOR INDIVIDUALS FROM TRIBAL
NATIONS AND I MENTIONED A COUPLE
OF THEM TODAY.
IF YOU WANT TO BUILD A STRONGER
RESEARCH INFRASTRUCTURE IN
INDIAN COUNTRY, BECAUSE THE
ULTIMATE GOAL IS TO DEVELOP A
CADRE, A STRONG CADRE OF
SCIENTIFIC INVESTIGATORS FROM
YOUR RESPECTIVE NATIONS WHO WILL
BE IN THE BEST POSSIBLE POSITION
TO APPLY FOR FUTURE FUNDING, WHO
WILL BE IN THE BEST POSSIBLE
POSITION TO ANALYZE DATA THISSA
IS COLLECTED FROM YOUR
COMMUNITIES AND THE BEST
POSSIBLE POSITION TO USE THOSE
DATA IN PRODUCTIVE WAYS TO
BENEFIT THE HEALTH.
YOUR RESPECTIVE NATIONS, SO ALL
OF THESE THINGS, YOU KNOW ARE
PART OF WHAT WE ARE TRYING TO DO
AT NIH.
>>IF I MAY ADD, ALSO,
DR. TABAK, I THINK ALSO MANY OF
THE TRAINING PROGRAMS WE ARE
INITIATING AT THE--AT ALL LEVELS
WHETHER IT'S IN GRAD SCHOOL,
UNDERGRAD OR EVEN IN HIGH SCHOOL
IS TO TRY AND BUILD THIS CADRE
THAT DR. TABAK HAS MENTIONED OF
FUTURE RESEARCHERS FROM TRIBAL
NATIONS, SO THAT THEY ARE AN
INTEGRAL PART OF THE PROGRAMS
THAT WE'LL BE LAUNCHING IN THE
FUTURE.
>>SURE.
AND I THINK, YOU KNOW THIS ISSUE
STRUCTURAL RACISM IS A REALLY
TOUGH 1, RIGHT?
BECAUSE, YOU KNOW FOLKS LIKE
YOURSELF, DR. TABAK,
DR. EISINGER PART OF HOW YOU GOT
TO YOUR POSITION WAS BEING
SUCCESSFUL IN THESE DIFFERENT
STRUCTURES, YOU KNOW, ACADEMIA
WITHIN NIH AND PROGRAM OFFICERS,
ALSO ARE, YOU KNOW SUCCESSFUL
RESEARCHERS, YOU KNOW AND WE'VE
TALKED A LOT ABOUT CSR.
ONE OF THE SUGGESTIONS THAT I
HAD AND IT'S ALSO RELATED TO A
QUESTION IS SO I THINK THAT
THERE ARE EXAMPLES OF IN
HEALTHCARE OF HOW TRIBES WHICH
CARE WAS PREVIOUSLY PROVIDED BY
INDIAN HEALTH SERVICE, YOU KNOW
HOW TRIBES HAVE REALLY COMPACTED
THAT RESPONSIBILITY AND STARTED
TO PROVIDE THOSE SERVICES TO
THEIR OWN TRIBAL MEMBERS AND THE
ALASKA TRIBAL SYSTEM HAS, YOU
KNOW DRAMATICALLY CHANGED THE
HEALTHCARE SYSTEM AND HAS BEEN
ABLE TO YOU KNOW REALLY REBUILD
IT, I THINK FROM THE GROUND UP.
NOT THROWING OUT EVERYTHING,
RIGHT?
THERE WERE MANY SUCCESSFUL PARTS
OF INDIAN HEALTH SERVICE.
BUT YOU KNOW I GUESS THE
QUESTION THAT I HAVE IS, YOU
KNOW COULD NIH LEARN FROM SOME,
YOU KNOW, LEARN FROM THE
HEALTHCARE EXAMPLE OF HOW THAT
HAS BECOME A BETTER SYSTEM FOR
NATIVE PEOPLES, BUT YOU KNOW I
ALSO--WE'VE TALKED AT DIFFERENT
TIMES ON THE TAC OF TRIBAL SET
ASIDES BUT I AM WONDERING ABOUT
THIS CONCEPT OF COMPACTING WHICH
WOULD ENABLE, YOU KNOW, FUNDS,
TO GO DIRECTLY TO TRIBES OR
TRIBAL ENTITIES WHO CAN THEN
BUILD THE INFRASTRUCTURE IN A
WAY THAT REALLY WORKS INSTEAD OF
HAVING TO GO THROUGH THESE
DIFFERENT STRUCTURES WHICH
REALLY DON'T SHARE SOME OF
THE--MAYBE SOME OF THE SAME
VALUES, SOME OF THE SAME WAYS OF
LOOKING AT THE WORLD, AND YOU
KNOW ONCE AGAIN, I GUESS IT'S A
QUESTION I HAVE, OF WHY COULDN'T
THAT BE POSSIBLE?
>>YEAH, SO I GUESS THE SHORT
ANSWER IS IT IS POSSIBLE, WE ARE
BEGINNING TO EXPLORE APPROACHES
LIKE THIS.
I THINK AND ACTUALLY THIS WOULD
BE A GOOD CONVERSATION TO HAVE
WITH TAC IN THE FUTURE BECAUSE
THE VERY NATURE OF SCIENCE,
SCIENTIFIC INQUIRY IS SORT OF
UNIVERSAL ENGAGEMENT SHARING
INTERACTION AND SO FORTH AND SO,
YOU WOULD WANT TO DO THIS IN A
WAY--SO UNLIKE A HEALTHCARE
SYSTEM WHICH CAN BE--ISOLATED IS
NOT THE RIGHT WORD BUT I CAN'T
THINK OF A BETTER WORD AT THE
MOMENT.
UNLIKE A HEALTHCARE SYSTEM WHICH
CAN BE SET OFF ON THE SIDE AND
FUNCTION REALLY, REALLY WELL AND
DELIVER GREAT CARE, FOR SCIENCE
TO HAVE THE MAXIMUM IMPACT, IT
HAS TO BE COMPLETELY ENGAGING
WITH THE REST OF THE SCIENTIFIC
COMMUNITY.
SO WE HAVE TO STRIKE A BALANCE
BUT NO, I TAKE YOUR POINT AND WE
ARE--WE HAVE BEGUN THROUGH THE
NATIONAL INSTITUTE OF MINOR
HEALTH AND HEALTH DISPARITIES TO
PROVIDE SOME RESOURCES THAT ARE
NOT SUBSCRIBED TO PRECISELY WHAT
1 NEEDS TO DO WITH THEM AND THEY
>>IT IT CAN BE USED FOR
INFRASTRUCTURE.
I TAKE YOUR POINT THAT WE SHOULD
FIGURE OUT HOW TO DO MORE OF
THAT GOING FORWARD.
YEAH.
LET ME LEAVE AT IT AT THAT.
I DO TAKE YOUR POINT.
>>I APPRECIATE THAT, THANK YOU.
>>THANK YOU.
WE HAVE ANOTHER QUESTION.
>>GOOD AFTERNOON.
I REALLY APPRECIATE THE
OPPORTUNITY TO ASK QUESTIONS
THIS MORNING AND MY APOLOGIES
FOR JOINING LATE.
I WAS IN ANOTHER TRIBAL ADVISORY
GROUP MEETING THAT NEEDED MY
ATTENTION.
MY QUESTION FOR DR. TABAK AND I
APOLOGIZE IF THIS WAS ALREADY
DISCUSSED.
SO, I WAS JUST WONDERING, WHAT
IS REQUIRED OF INDIVIDUAL
RESEARCHERS AND P.I.s TO
DEMONSTRATE TRIBAL SUPPORT BUT
ALSO CONSIDERING SUPPORT THAT
INVOLVES AMERICAN INDIAN, ALASKA
NATIVES, WITH DATA THAT IS
SELECTED OFF THE RESERVATION.
AND I WAS WONDERING, DOES THE
GUIDANCE DOCUMENT INCLUDE
LANGUAGE THAT TALKS ABOUT THIS
SPECIFIC TYPE OF, THIS UNIQUE
SITUATION, BECAUSE PROTECTION
SHOULD BE IN PLACE AS WELL.
>>LET ME TURN TO DAVE WHO WILL
ARTICULATE THIS MORE CLEARLY
THAN I WILL.
>>YES, THANK YOU DR. TABAK.
THE DOCUMENT WILL ADDRESS ALL OF
THOSE POINTS AND ITEMS.
THE -- THOSE WHO WE BROUGHT
TOGETHER, WHO PROVIDED CRITICAL
INPUT ABOUT THE CONSIDERATIONS
THAT NEED TODAY LOOKED AT AND
ADDRESSED BEFORE REECE SEARCH
CAN MOVE FORWARD.
THOSE ARE DEFINITELY INCLUDED IN
THAT DOCUMENT.
PLEASE STAY TUNED WE'RE
ANTICIPATING THE RELEASE OF THIS
DOCUMENT TO BE AN INSTRUMENTAL
PART OF HOW WE INCLUDE SOME OF
THE MOVE VULNERABLE, I WOULD
SAY, OR THOSE THAT ARE HIGH
SUSCEPTIBLE TO MAKE THEM TAKE
ADVANTAGE OF THE IMPORTANT
BIOMEDICAL RESEARCH FINDINGS
THAT HAPPENED AT NIH.
SO, YEAH.
I'LL LEAVE IT AT THAT.
>>CURRENTLY, WHAT REQUIRED OF
RESEARCHERS TO DEMONSTRATE
TRIBAL SUPPORT BECAUSE I KNOW,
TRIBAL RESOLUTIONS IS WHAT SEEMS
TO HAPPEN.
WHAT I WITNESS IS THAT A TRIBAL
RESOLUTION WILL BE OBTAINED FROM
A TRIBAL CONSORTIUM, BUT NOT
WITH THE INDIVIDUAL TRIBAL
NATIONS AND SO THAT CIRCUMVENTS
AND IT IF THEY WANT TO SUPPORT A
PARTICULAR STUDY SO I'M JUST
WONDERING, YOU KNOW -- I JUST
WANTED TO RAISE THAT AS AN ISSUE
BECAUSE IT'S A CONCERN IN OUR
AREA WITH RESEARCH THAT IS
HAPPENING.
>>IF I MAY, Dr. ADAM BERGER
FROM THE OFFICE OF SCIENCE
POLICY AND Dr. HALL WILL BE
GOING INTO THIS IN DETAIL IN A
PRESENTATION AT 4:25 TODAY.
>>THANK YOU.
>>SURE.
>>THANK YOU.
WE'LL GO TO Dr. JIM.
>>HI, THANK YOU.
THIS IS WITH NAVAHO NATION AND
I'M TRAVELING RIGHT NOW SO I
DON'T HAVE MY VIDEO.
I WANT TO ADDRESS ONE ISSUE THAT
CAME UP, I THINK IT'S A GOOD, I
GUESS, COMPLIMENT TO THE
QUESTION ABOUT THE
ACKNOWLEDGMENT OF THE TRIBAL
IRBs AND WE RECENTLY HAD AN
INCIDENT HERE ON NAVAJO WHERE
THE, I THINK IT'S THE -- I'M NOT
SURE WHICH COMPANY, IT WAS THE
NATIONAL COMPANY THAT CAME OUT
AND CONDUCTED -- THEY WERE
ENROLLING NAVAJO NATION
ADVOCATES THAT CAN DETECT BLOOD
AND WHAT NOT IS AT OUR FLEA
MARKET AND WE BROUGHT IN MOBILE
UNITS THAT ELI LILLY AND COMPANY
I THINK THAT'S WHAT IT IS CALLED
AND WE FOUND OUT THEY WEREN'T
AWARE THEY'RE NATIVE TO THE
NAVAJO NATION IRB APPROVAL AND
OUR HUMAN RESEARCH STAFF WENT
DOWN THERE AND ASKED, I GUESS,
HE MISSED THE WHOLE VAN INCIDENT
WHERE THEY COLLECTED SAMPLES AND
RECRUITED SOME INDIVIDUALS BUT
THEY WERE NOT AWARE THERE WAS A
TRIBAL IRB THEY NEED TODAY GO
THROUGH.
WE'RE STILL IN COMMUNICATION
WITH THE COMPANY AND I THINK
IT'S A SITUATION OR ISSUE THAT I
HOPE THAT IS IS ON YOUR LIST
WHEN YOU GUYS ARE LOOKING AT
GRANT APPLICATIONS THAT THERE IS
AN ACKNOWLEDGMENT OF THE TRIBAL
IRB AND FOR EXAMPLE, FOR THE
NAVAJO NATION WE HAVE AN IRB BUT
FOR SOME REASON THIS COMPANY, I
ASSUME, IS THE NATIONAL COMPANY,
WAS NOT AWARE THEY NEED OF TODAY
A TRIBAL IRB NUMBER AND THEY
WERE COLLECTING SAMPLES FROM
VICTIINDIVIDUALS SO WE'LL FURTHR
FIGURE OUT WHAT WAS TALLLY
HAPPENING BUT I WANT TODAY SHARE
THAT.
THANK YOU.
>>SO, I DON'T KNOW ABOUT THIS
SPECIFIC CIRCUMSTANCES ELI LILLY
IS IS A INTERNATIONAL COMPANY, A
MEGA COMPANY.
AGAIN, I HAD NEVER SAY NEVER BUT
IT'S HIGHLY UNLIKELY THEY HAVE
NIH FUNDING BECAUSE THE REALLY
LARGE PHARMACEUTICAL COMPANIES
DON'T GET NIH FUNDING.
AGAIN, I DON'T KNOW THE
SPECIFICS.
IF YOU DO FIND THAT NIH IN HOW
INVOLVED, PLEASE IMMEDIATELY LET
US KNOW BECAUSE AS YOU WELL
KNOW, WHAT YOU JUST OUTLINED IS
IS NOT APPROPRIATE BEHAVIOR AND
WE WOULD WANT TO DO WHAT WE CAN
TO ENSURE IT NEVER HAPPENS
AGAIN.
AGAIN, ELI LILLY IS IS APP AN
INTERNATIONAL COMPANY.
I DON'T THINK THEY WOULD HAVE
NIH FUNDING.
I NEVER, I HAVE LEARNED NEVER TO
SAY NEVER.
>>HOW ARE WE WITH THE TIME?
>>I'M AT TIME BUT IF THERE WAS
ONE ADDITIONAL QUESTION.
>>OK, WE HAVE ONE MORE QUESTION
FOR OUR DELEGATE.
>>GOOD AFTER I'M VICE PRESIDENT
FOR THE TRIBE AND I WANTED TO
ABOUT AFTER Dr. GYM'S COMMENT
MAYBE WE SHOULD GET A LIST OF
THE TRIBAL IRBs OR RRBs TO
NIH SO THEY'RE AWARE OF THOSE.
AND THEN, BECAUSE THOSE WOULD BE
THE PLACES WHERE INDIVIDUAL
TRIBES WOULD GET THEIR APPROVAL,
RIGHT.
THEY WOULD GO THROUGH THE TRIBAL
IRB OR RRB TO GET INDIVIDUAL
TRIBAL APPROVALS SO GOING BACK
TO THE QUESTION OF COMPACTING, I
DON'T KNOW OF ANY DIRECT FUNDING
THAT IS GIVEN TO TRIBES FROM NIH
THAT WE COULD 638 CONTRACT.
JUST USE APP EXAMPLE OF THE
ALASKA HEALTH CENTER BECAUSE
THAT WAS 638 CONTRACT SOD IF
APPROXIMATE A TRIBE CONTRACTS A
SERVICE THAT'S BEING PROVIDED BY
IHS OR ANOTHER GOVERNMENTAL
ENTITIES, WE'LL GET THOSE MONEY
DIRECT TO CONTINUE THAT WORK AND
HOWEVER WE DETERMINE
SELF-DETERMINATION, RIGHT.
SO I'M NOT SURE OF ANY NIH
FUNDING THAT GOES DIRECTLY TO
TRIBES THAT WE CAN 638 CONTRACT
AND MAYBE THE IRBs AND RRBs
COULD BE ONE OF THOSE THINGS WE
THINK ABOUT AS SNAG COULD
CONTRACT WHICH WOULD ENCOURAGE
DESCRIBES TO GET THEIR OWN IRB
AND RRB AND THEN THEY WOULD GET
INDIVIDUAL CONCEPT FROM -- AND
GO THROUGH THE PROCESS OF
ENSURING SAFETY AND THE RISK OF
BENEFITS ARE APPROVED AND ALL
THOSE PIECES ARE RESEARCH ARE
APPROVED BY THE DESCRIBES
INDIVIDUALLY SO I JUST WANTED TO
THROW THAT THOUGHT OUT THERE AND
RELATION TO THE COMPACTING
COMMENT AS WELL AS BRINGING UP
THE IRB AND RRBs.
THANK YOU.
>>THANK YOU.
YOU ARE WAY AHEAD OF ME MY
UNDERSTANDING IS THAT, AND Dr.
WILSON MAY BE ABLE TO ELABORATE.
WE HAVE AT LEAST ONE VEHICLE
THAT NIMHD CURRENTLY EMPLOYING
THAT A LOUSE LATITUDE TO THE
CRIME NATIONS FOR WHAT THE
RESOURCES THAT ARE PROVIDED IS
USED FOR BUT I DON'T KNOW IF
IT'S RELATED TO WHAT YOU JUST
REFERRED TO.
DO YOU HAVE ANY?
>>YEAH, THANK YOU Dr. TABAK.
IT'S NOT IN RELATION TO THE
NIMHD INITIATIVE BUT IT IS, I
THINK IT IS SOMETHING THAT YOU
HAD MENTIONED EARLIER THAT WE
SHOULD TABLE AND SAY FOR A
FUTURE DISCUSSION BECAUSE
THERE'S A LOT OF I INTRICACIES
THAT WE HAD WHEN WE HAD THIS
CONVERSATION.
>>BUT I THINK IT'S ONE THAT WE
SHOULD RETURN TO IN THE FUTURE?
>>YES.
>>OK.
I THINK WE HAVE LAST COMMENT.
>>I JUST HAVE ONE COMMENT.
RELATED TO VICE PRESIDENT
MUSSO'S QUESTION ABOUT THE LIST
OF IRBs AND THE INDIAN HOUSE
SERVICE NATIONAL IRB USED TO
MAINTAIN A LIST OF ALL INDIAN
HEALTH SERVICE IRBs AND MANY
OF THE TRIBAL IRBs AND I DON'T
KNOW IF THEY STILL DO THAT OR
STILL MAINTAINED BUT YOU CAN GO
TO THE IHS WEBSITE AND GET A LOT
OF THE INFORMATION ABOUT THE
IRBs THAT EXIST AND MANY OF
THE TRIBAL IRBs.
THANK YOU.
>>THANK YOU, WE'LL LOOK INTO
THAT.
THANK YOU.
>>THANK YOU DR. TABAK FOR
MEETING WITH US.
I KNOW WE COULD USE MORE TIME,
BUT WE DO APPRECIATE THE TIME
THAT YOU DID SHARE WITH US AND
WE DO LOOK FORWARD TO HAVING
ANOTHER DAY TOMORROW AND SO I
HOPE THAT WHEN WE GATHER ALL
THIS INFORMATION, YOU CAN TAKE A
LOOK AT WHAT WE ACCOMPLISHED IN
THE NEXT, WITHIN THESE MEETINGS
AND WE LOOK FORWARD TO
CONTINUING TO WORK WITH YOU AND
WITH THIS ACCOMPLISHING GOOD
THINGS FOR ALL OF US.
THANK YOU.
>>THANK YOU SO MUCH.
I LOOK FORWARD TO THAT AS WELL.
THANK YOU, EVERYBODY.
>>BYE-BYE.
>>ALL RIGHT, DAVE, Dr. WILL
SOP, WE'RE GOING ON BREAK NOW.
>>WE ARE.
THANK YOU SO MUCH FOR REMINDING
US AND I'M SURE THAT EVERYBODY
IS READY FOR A QUICK BREAK.
IF WE CAN RECONVENE AT 3:25 SO
THAT WOULD BE IN ABOUT 19
MINUTES FROM NOW.
SO THAT WE CAN HEAR OUR
PRESENTATIONS FROM Dr. PER
HE'S STABLPEREZ-STABLE.
THE NATIONAL INSTITUTE ON
MINORITY HEALTH AND HEALTHCARE
PARTIES.
THANK YOU FOR A ROBUST
CONVERSATION WITH Dr. TABAK, I
APPRECIATE THAT.
>>WELCOME BACK, I WANT TO SAY A
FEW THINGS BEFORE I INTRODUCE
OUR NEXT SPEAKER.
WE WANTED TO GET INTO OUR
DISCUSSION WITH Dr. TABAK AND
WE HAD A WONDERFUL CONVERSATION
WITH HIM.
AS YOU KNOW WE HAVE A PACKED
AGENDA AND NEXT IS GOING TO BE
Dr. PEREZ-STABLE WHO IS THE
DIRECTOR OF THE NATIONAL
INSTITUTE OF MINORITY HEATH AND
HEALTH DISPARITIES.
HE TALK ABOUT THE TRIBAL DATA
REPOSITORY AND FUNDING FUNDS FOR
THE TRIBAL EPIDEMIOLOGY CENTERS
AND FOLLOWED BY THAT
PRESENTATION, WE'RE GOING TO
HAVE A PRESENTATION ON
ARTIFICIAL INTELLIGENCE AND THEN
FOLLOWING THAT, THE
MUCH-ANTICIPATED CONVERSATION
AROUND THE NIH POLICY
PROTECTIONS AND IMPLICATIONS FOR
ETHICAL CONDUCT OF RESEARCH WITH
TRIBAL COMMUNITIES.
THIS INCLUDING GENETIC RESEARCH.
SO WE HAVE A WONDERFUL AGENDA
AND WE ARE POSTING THE
REPRESENTATIONS INTO THE NIH BOX
SYSTEM AND YOU ALL HAVE ACCESS
TO.
SO, PLEASE, IF YOU HAVE THE
OPPORTUNITY, GO IN AND REVIEW
THE PRESENTATIONS FOR TOMORROW.
WITH THAT I WANT TO SAY, LET'S
INTRODUCE WELCOME OUR NEXT
SPEAKER.
Dr. PEREZ-STABLE WHO IS GOING
TO TALK ABOUT THE TRIBE DATA
REPOSITORY AND EPICENTRE FUNDING
INITIATIVES AT NIMHD.
>>EVERYONE HEAR ME OK?
THANK YOU, VERY MUCH, DAVE AND
IT'S AN HONOR TO BE WITH YOU.
CONSIDER FRIENDS AT NIMHD
ADDRESSING MINORITY HEALTH AND
HEALTH DISPARITIES IS VERY MUCH
ALIGNED WITH THE NEEDS OF TRIBAL
COMMUNITIES.
I'M GOING TO SHARE MY SCREEN TO
SHOW YOU THE SLIDES I PREPARED
FOR TODAY AND I'VE BEEN AT NIH
FOR SEVEN AND A HALF YEARS AND
THERE'S NEVER A DAY THAT I DON'T
LEARN SOMETHING.
I WANT TO START WITH A BIT OF
APP UP BEAT NOTE ABOUT THE
EXPERIENCE OF THE PANDEMIC.
THESE ARE DATA THAT ARE A YEAR
OLD BUT IT'S THE LAST THING THAT
MMWR PUBLISHED ON IMMUNIZATIONS.
YOU CAN SEE HERE, WHERE WE WERE
IN APRIL OF 2021, FIVE MONTHS
AFTER THE VACCINE, IT WAS
AVAILABLE AND WHERE WE ARE AND
WERE IN NOVEMBER 2021 SO MARKED
INCREASES THAT DIDN'T ELIMINATE
BUT DIMINISHED AK IS CEASE AND
AMERICAN AND ALASKA NATIVES YOU
FURTHER HYPED BUT THEY WORKED TO
BEGIN WITH AND I THINK THAT THIS
IS SOMETHING THAT ALL OF YOU,
ALL OF US, REALLY WORKED HARD TO
ADDRESS AND THIS IS CREDIT THAT
GOES TO THEM.
MORE IMPORTANTLY, THESE ARE DATA
THAT WERE ACTUALLY PUT TOGETHER
BY THE "NEW YORK TIMES" AND FROM
THE CKC AND THESE ARE NOT
ADJUSTED FOR AGE BUT THE
IMPORTANT THING AS OF THE SUMMER
OF THIS YEAR, THESE LINES WERE
NOT SEPARATE AND WITH A LIT OF
DIFFERENCE HERE, SLIGHTLY HIGHER
FOR ONE GROUP AND LOWER FOR
ANOTHER GROUP AND THE DEATH
RATES ACROSS THE COUNTRY, WHICH
WERE DIFFERENT FROM THE
BEGINNING OF THE PANDEMIC AND
WITH DIFFERENT SURGES AND WE SEE
AMERICAN INDIAN AND ALASKA
NATIVE SURGE AND LATINO
HISPANICS WERE UP ALL THE TIME
AND IN THESE ARE REALLY GONE
MOSTLY AWAY FOR NOW.
LET'S SEE WHAT HAPPENS THIS
WINTER.
AND THIS IS AGAIN CREDIT TO OUR
COMMUNITIES AND CREDIT TO THE
PROFESSIONALS, IN OUR
COMMUNITIES AND IT IT REALLY
WENT OUT OF THEIR WAY TO PROMOTE
THE VACCINES AND THIS ALL IN
EFFECT OF ACCEPTING AND GETTING
VACCINATED.
SO SWITCHING TO RADX UP, THESE
ARE THE PROJECTS THAT ARE FUNDED
THAT INCLUDE SIGNIFICANT NOT
NUMBERS OF AMERICAN INDIAN AND
ALASKA NATIVES, AND IT'S ALL THE
WAY OUT TO GUAM.
HAD ARE PRIMARY PROJECTS FUNDED
TO FOCUS ON NATIVE POPULATIONS
AND THEY ARE LISTED HERE.
I THINK IN THIS AUDIENCE, I
PREVIOUSLY WENT THROUGH THE
PROJECTS AND THE IPSOS-REID
TUESDAY OF THE TRIBAL DATA
REPOSITORY CONSULTATION AND
THESE ARE THE PRINCIPLE
INVESTIGATORS AND WITH BRIEF
SUMMARY AT THE BEGINNING AND THE
LOCATE OF WHERE THEY'RE WORKING
AND YOU WILL HAVE ACCESS TO
THOSE SLIDES.
IT'S WELL-KNOWN INVESTIGATORS
AND NEW INVESTIGATORS AND NOT
ALL OF NARRATIVE NAR NATIVE AND.
THEY'RE ALL ACADEMIC AWARDEES
WITH THE CHAR KEY NATION BEING
THE EXCEPTION.
SO RADX UP NOW INTO ITS
APPROACHING ITS THIRD YEAR OF
APPROPRIATIONS, HAS BEEN A
REMARKABLE EXPERIENCE FOR US AT
NIH.
IT'S IN MANY WAYS THE SINGLE
LARGEST INVESTMENTS APPROXIMATE
ADDRESSING HEALTH DISPARITIES AT
THE NIH EVER CUP AND OF COURSE
IT WAS IN RESPONSE TO THE
PANDEMIC SO WE UNDERSTAND THAT
BUT IT STILL IS DAUNTING O
REFLECT ON WHAT HAS BEEN
ACCOMPLISHED AND WE HAVE FUNDED
137 UNIQUE PROJECTS AND AND IT
WILL BE CRITICAL FOR THE TRIBAL
REPOSITORY.
OVER 350,000 UNIQUE PARTICIPANTS
HAVE BEEN EP ROLLED AND THEIR
DATA HAVE BEEN SHARED, EXCLUDING
THE NATIVE POP LAY TIVE THAT HAS
NOT BEEN SHARED BECAUSE OF
OBVIOUS TRIBAL GOVERNANCE BUT
THIS IS JUST AN AMAZING WEALTH
OF INFORMATION THAT IS AVAILABLE
FOR NOT ONLY FOR MAIN TAPING IT
IT BUT FOR ANALYSIS.
MANY TESTS HAVE BEEN DONE AND
ABSTRACTIONS FROM ELECTRIC
TROPIC HEALTH RECORDS, ET
CETERA.
AND ON NOVEMBER 29th AMERICAN
JO JOURNALOF HEALTH SPECIAL SUPS
PUBLISHED.
SO THE IDEA OF THE TRIBAL DATA
REPOSITORY WAS CAME OUT OF THE
OFFICE OF DATA SCIENCE
STRATEGIES IN DISCUSSIONS WITH
THE LEADERSHIP OF RADX, THE
WHOLE RADX INITIATIVE AND
RADX-UP AND IT UNDERWENT INPUT
FROM A FORMAL TRIBAL
CONSULTATION LAST YEAR.
THE FUNDING COMES FROM THIS RADX
APPROPRIATIONS AND NIMHD AGREED
TO MANAGE THE GRANTS AND SO IT
WILL BE HOUSED IN OUR IPSOS-REID
TO UINSTITUTESSO OUR STAFF WILL.
IT'S REALLY TO FACILITATE AND
PROCESS WHAT DATA ARE PRODUCED
FROM THESE 10 PROJECTS TO
DECIDED WHAT TO DO WITH THE
UNAFFILIATED AMERICAN INDIAN AND
ALASKA NATIVE PARTICIPANTS THEY
WERE SCAREDDERED THERE AND MAKE
SENSE AND CONTRIBUTE TO THE
KNOWLEDGE OF COVID-19 AND MAKING
DECISIONS FOR THEIR COMMUNITIES
COMMUNITIES NOT ONLY FOR NOW AND
UNDERSTANDING WHAT HAPPENS NOW
BUT ALSO PREPARATION FOR FUTURE.
SO DEVELOPING THIS INDEPENDENT
RESEARCH DATA REPOSITORY GOVERN
UNDER PRINCIPLES AND PRACTICES
OF TRIBAL SOVEREIGNTY FOR DATA
SHARING, IS REALLY THE PRIMARY
REASON THAT THIS WAS DONE.
AND PROVIDE ACCESS TO
RESEARCHERS AND THEIR
COLLABORATIVES WHO ARE GENERAL
RATING AND INTERESTED WORKING
WITH RADX, AI EX AN DATA.
SO THE RECIPIENT OF THE AWARD
WILL WORK WITH AT LEAST WITH
THOSE 10 PROJECTS AND WHOEVER
ELSE IS INTERESTED IN WANTS TO
COLLABORATE ON THIS WILL AND THE
TRAVEL DATA REPOSITORY WILL BE
NIH SUPPORTED BUT GOVERNED BY
THE TRIBAL GOV YOUR WORSHIPPANCE
AND NOT BY NIH.
WE DO HAVE THE COR DEPOSITATION
AND DATA COLLECTION CENTER WHICH
IS BEEN OUTSTANDING AND THEY ARE
AWARE OF HAD AND THEY'RE
KNOWLEDGEABLE ABOUT THIS AND
THEY'RE STANDING BY WHEN WE MAKE
THE AWARD TO REALLY SUPPORT AND
HELP GETTING ESPECIALLY ON THE
TECHNICAL SIDE, OF COURSE, THEY
HAVE BEEN COMMUNICATING WITH THE
10 RADX-UP PROJECTS SO THEY'RE
AWARE OF THE DIFFERENT
INDIVIDUAL PROJECTS SO THIS IS A
WAY TO COORDINATE THAT.
THE IDEA ALSO TO SUPPORT OTHER
NATIVE RESEARCHERS AND OTHER
SCIENTISTS WORKING IN THESE
COMMUNITIES WILL HAVE FOURTH
FROM THAT AND WE HOPE WE WILL
LEARN FROM THIS TO HELP US
UNDERSTAND MORE ABOUT HOW TO
RESPOND AND MANAGE ISSUES WITH
THE PANDEMIC.
SOMEHOW I DIDN'T GET THE RIGHT
SET OF SLIDES SO I APOLOGIZE.
THE TRIBAL DATA REPOSITORY WILL
BE A NIH SUPPORTED TRIBAL COULD
HAVE ERNIE POS TORI AND I AM
CORPORATES AND SUSTAINED TRIBAL
SOVEREIGNTY PROVIDES RESEARCH
ACROSS THE PROJECTS AND BETTER
UNDERSTANDING OF THE IMPACT OF
COVID-19 AND DATA THAT THE
TRIBAL HEALTH BOARDS.
LET ME JUST CHECK THIS IS THE
RIGHT ONE AND I DON'T KNOW WHAT
HAPPENED.
OK.
LET ME TRY AGAIN.
MOST OF THOSE FIRST ONES WERE
NOT DIFFERENT.
SO -- TAKE MY WORD FOR IT.
WE HAVE MADE A SELECTION FOR THE
AWARDEE BUT THE AWARD HASN'T
BEEN MADE.
SO, I CAN'T TELL YOU WHO THE
RECIPIENT IS.
NOT YET.
WE HOPE TO BE ABLE TO ANNOUNCE E
THE AWARD LATER THIS MONTH, AT
THE LATEST THE BEGINNING OF
2023.
THIS ARE ALL THESE DETAILS WITH
GRANTS MANAGEMENT THAT NEED TO
BE DISCUSSED.
WE'RE LOOKING AT THIS A NEW
PROCESS AND NEW IT'S NEW FOR NIH
AND TO APPROACH THIS CHALLENGE
THIS WAY AND IN THE PAST I THINK
MOSTLY IT HAS BEEN EITHER DONE
INCORRECTLY OR IGNORED AND OR
SORT OF SAYING LET'S LET SOME
ELSE WORRY ABOUT IT KIND OF
THING AND IT'S A $2 MILLION
TOTAL COST PER YEAR FOR FOUR
YEARS AND IT'S MONEY TOLL RADX
AND ALL THE STAFF TIME INVOLVED
OF MENTIONED STEP-BY-STEP ADVICE
AND PARTNERSHIP WITH DAVE WILSON
AND THE TRIBAL HEALTH RESEARCHEL
OFFER AND AS WELL AS THE OFFICE
OF DATA SCIENCE STRATEGIES SO I
THINK THAT NOT NOTHING WITHOUT
RISK BUT OF WE'RE VERY EXCITED
AND NOT BEAT ABOUT WHAT HAD
REPRESENTS AND WE WILL WORK I AM
IT TENSELY TO MAKE THIS A
SUCCESSFUL PROJECT.
SO LET ME WITCH GEARS AND TALK
APPROXIMATE THE PRESCRIBE
EPIDEMIOLOGY CENTERS AND I'LL
START WITH A FRAMING WITH
INFORMATION YOU ARE AWARE OF AND
WHICH IT'S THE CENSUS IN 2020
COUNTED ALMOST 0 MILLION
INDIVIDUALS WHO SELF-IDENTIFIED
AS AMERICAN INDIAN AND ALASKA
NATIVE EITHER PRIMARILY OR
EXCLUSIVELY OR IN THE GROUP OF
MORE THAN ONE RACE AND IT IT
THERED THE WAY THEY DID THE
ALGORITHM OF COUNTING PEOPLE WHO
IDENTIFIED AS MORE THAN ONE RACE
AND THIS IS IS MOSTLY EFFECTED
THE LATINO HISPANIC POPULATION
AND AMERICAN INDIAN ALASKA
NATIVE AND SO IT'S ALMOST 3% OF
THE U.S. POPULATION.
AND THE TRIBAL EPIDEMIOLOGY
CENTERS ARE ESTABLISHED IN 1996
AND UNDER THE RE AUTHORIZATION
OF THE HEALTHCARE IMPROVEMENT
ACT AND FUNDED BY THE INDIAN
HEALTH SERVICE AT THE TIME.
AND MOBILIZATION OF EMERGENCY
RESPONSE TO PUBLIC-HEALTH
CRISIS.
AND HISTORICALLY, MOST OF THE
SUPPORT HAS BEEN FROM THE INDIAN
HEALTH SERVICE AND CENTER FOR
DISEASE CONTROL AND PREVENTION
AND WITH MUCH OF IT REALLY ON
THIS CAPACITY BUILDING FROM THE
CDC.
THE NATIONAL INSTITUTE OF
MINORITY HEALTH HEALTH
DISPARITIES BEGAN PROVIDING
SUPPORT FROM THE TAX ABOUT 18
YEARS AGO OR O AND SOMETHING
AROUND 2004 AND 2005 UNDER THE
DIRECTOR JOHN RUFFIN AT THE
TIME.
THIS IS A MAP AND IT THEY MATCH
AND THERE ARE 12 TEXT WITHIN
EACH OF THE ADMINISTRATIVE
REGIONS WITH THE URBAN HEALTH,
URBAN INSTITUTE REPRESENTING
URBAN INDIANS AND SO THE GOALS
OF THIS TECH RESOURCE CENTER AND
IT WAS TO PROVIDE A MECHANISM
WHICH NIMHD WOULD MANAGE AND
CONTROL THE TRANSFER OF FUNDS.
ALL OF OUR EVERY YEAR WE'VE BEEN
DOING THIS WE'VE BEEN
TRANSFERRING FUNDS TO THE INDIAN
HEALTH SERVICE AND THAT WAS --
TO CONTINUE THE ACTIVITIES AND
THAT THEY HAVE BEEN SUPPORTED
FOR THE ADDITIONAL COMPONENTS
THAT WERE ADDED TO THE U24 WERE
OPTIONAL TO PROVIDE TECHNICAL
ASSISTANCE FOR CONSULTATIONS,
WEBINARS AND WORKSHOPS FOCUSED
ON BUILDING CAPACITY FOR
RESEARCH AND DEVELOP, WHETHER
IT'S MONITORING, SPECIFIC
CONSULTATIONS AND PARTICULARLY
WE WANTED TO FOCUS ON EARLY
STAGE INVESTIGATORS BASED IN THE
TAX OR ASSOCIAT ASSOCIATE LOOSEH
THE TAX.
WHEN WE FIRST DISCUSSED THIS
WITH THE INDIAN HEALTH SERVICE
LEADERSHIP THEY RECOMMENDED THAT
THEY INCLUDE ALL THE TRIBAL
ORGANIZATION AND WE'LL DEVELOP A
PROCESSES BY WHICH THAT CAN BE
DONE AND I KNOW I'VE HAD SOME
DISCUSSION AND WE'LL IMPLEMENT
ONE OF THESE AND WE CAN ACT AS A
FUNNEL FOR INFORMATION ABOUT NIH
CONDUCT TO OTHER NIH INITIATIVES
AND PROVIDE AN OPPORTUNITY FOR
ENOUGH TO SUPPORT WORK AND THE
TEXT AND OTHER TRIBAL
ORGANIZATIONS.
THE AWARD WAS MADE TO THE
UNIVERSITY OF COLORADO UNDER THE
PRINCIPLE INVESTIGATORS MANSON
AND JOAN OWE CON HE WILL AND
IT'S THE COLORADO RESEARCH
CENTER FOR EPIDEMIOLOGY CENTERS
AND THE TOTAL FUNDING IS
2.286 MILLION IT'S ABOUT ONE AND
A HALF MILLION NOT QUITE IN
DIRECT COST AND PER YEAR FOR
FIVE YEARS.
AND SO WE'LL HELP FACILITATE THE
SUPPORT FOR EACH AND CREATION OF
THIS HUB FOR TECHNICAL
ASSISTANCE AS WELL AS ALL THIS
INSTRUCTIONAL MATERIAL OR COURSE
AND I SEE THIS AS A FIRST STEP
TO REALLY CREATE A NETWORK AND
DATA SIGNS AND THE OFFICE OF
DATA SCIENCE HEARD WE WERE DOING
THIS AND SAID WE'LL PROVIDE SOME
EXTRA SUPPORT SO THERE'S NOWHERE
DATA SCIENCE CAPACITY BUILDING.
FUL BUT THERE ARE OTHER OPTIONS
FOR INSTITUTES THAT MAY WANT TO
DO A PARTICULAR TOPIC FOCUSED ON
AMERICAN INDIAN AND ALASKA
NATIVE POPULATION AND THIS COULD
PROVIDE NOT MONEY TO THE
RESEARCH CENTER BUT SAY WE HAVE
RESEARCH ON CARDIOVASCULAR OR
CANCER OR SUBSTANCE USE AND THEN
HELP USE THE RESOURCE CENTER AS
A WAY MAKE THAT HAPPEN AND USE
THE TAXES AS A CONDUIT OF
RECIPIENT OR APPLYING FOR GRANTS
OR COMMUNICATING WITH POTENTIAL
INVESTIGATORS WITHIN THEIR AREA.
AND THE NETWORK OF TRIBAL BASED
ORGANIZATIONS TO CONDUCT
RESEARCH AND BY NATIVE
INVESTIGATORS AND IT'S THE
ULTIMATE VISION OF THIS GROW TO
AND USE THE LEVERAGE AND THE
INFRASTRUCTURE THE 25 YEARS
HISTORY TO BUILD ON THAT AND
FIND WAYS FOR NIH TO HELP
SUPPORT IT.
AS I MENTIONED THIS RESEARCH
GRANTS THAT COULD COME IN
SEPARATE AND THEY COULD RESPONSE
TO URGENT ISSUES AS RESPONSE
WITH COVID OR CAPACITY BUILDING
IN ONE OR ANOTHER PARTICULAR
AREA AND WE HAVE THE EXPERIENCE
OF WORKING WITH A RESEARCH
CENTERS FOR MINORITY
INSTITUTIONS AND THEY FUNCTION
IN THIS WAY AND OVER THE LAST
SEVEN OR EIGHT YEARS OF
TRANSITION TO BECOME MORE LIKE
THAT SO I THINK SOMETHING THAT
WILL REFLECT POSSIBILITIES.
I THINK THAT'S IT FOR MY
PRESENTATION.
JUST A REMINDER OF THE VISION ON
RESEARCH FRAMEWORK OF INDIVIDUAL
AND INCOMPETENTER PERSONAL
RESEARCH AND ALSO COMMUNITY AND
SOCIETAL ON THE DIFFERENT
DOMAINS IS LISTED INCLUDING
HEALTH-CARE SYSTEM AS WELL AS
BIOLOGY, BEHAVIOR AND THE
ENVIRONMENT.
SO, I'LL END THERE AND LET ME
SEE I CAN MAKE THE EXIT'S YEAR
THAN THE ENTER TRANCE.
AND STOP SHARING.
THERE'S BOBBIE SAKI.
>>MY HAND WILL ALWAYS POP UP AT
SOME POINT OR ANOTHER.
I HAD A QUESTION ABOUT THE DATA
CONCERNS.
A COUPLE OF MY COLLEAGUES HERE
IN OKLAHOMA AND OUTSIDE OF
OKLAHOMA WERE PART OF A AMERICAN
INDIAN ALASKA SUBCOMMITTEE ON
RADX-UP PROJECTS AND FOR THE
DATA THERE WERE QUITE A FEW
CONCERNS THEY LISTED EARLIER
THIS YEAR ABOUT THE REPOSITORY
AND KIND OF THE GOVERNANCE OF IT
AND THINGS LIKE THAT AND SO I
WAS WONDERING IF YOU COULD SPEAK
TO SOME OF THOSE OR IF YOU ARE
FAMILIAR WITH THOSE CONCERNS
THAT THEY HAD, AND HOW THOSE
CONCERNS WERE ADDRESSED BECAUSE
FROM WHAT I UNDERSTAND THERE WAS
QUITE A FEW CONCERNS FROM THE
SUBCOMMITTEE ABOUT HOW THIS DATA
WAS GOING TO BE GOVERNED AND
EXCESS AND ET CETERA AND ET
CETERA.
THANK YOU.
>>WELL, I CAN'T SAY THAT I KNOW
THE DETAILS OF WHAT YOU ARE
REFERRING TO BECAUSE SO MUCH
COMES THROUGH THAT I HEAR ABOUT.
WE KNOW THAT GOING IN THE
PROJECTS THAT WE WERE FUNDING
THAT WERE COLLECTING DATA AND
WORKING IN WOULD NOT SHARE THEIR
DATA BECAUSE OF TRIBAL
GOVERNANCE AND WE KNEW THAT SO
MOST, I THINK MOST IF NOT ALL OF
THEM, DECLINED TO SHARE THEIR
DATA AND THERE WERE A LOT OF
ISSUES RAISED BY DIFFERENT
RESEARCHERS AND COMMUNITIES
ABOUT THE USE OF THE COMMON DATA
ELEMENTS THAT WE ASKED EVERY
PROJECT TO USE AND IT WAS
SOMETHING THAT CAME FROM NIH
LEADERSHIP AND I PARTICIPATED IN
THAT AND THERE WERE QUESTIONS
ABOUT OTHER RELATED CONDITIONS
AS WELL AS COVID-19 SYMPTOMS,
DID YOU GET TESTED, HAVE YOU
BEEN DIAGNOSED THAT KIND OF
THING.
I THINK THAT'S TO BE EXPECTED.
I DON'T RECALL THERE WAS A
SPECIAL ISSUE WITH THE AMERICAN
INDIAN PROJECTS YES THERE WERE
CONCERNS FROM THE UP WITH OF THE
PROJECTS IN OKLAHOMA, ACTUALLY
AND THAT HAD TO DO, WE MET WITH
INVESTIGATORS AND THERE WERE
ISSUES WITH THE POPULATION AND
SOME PEOPLE SAID WE WOULDN'T DO
THIS AND YOU CAN'T MAKE US BUT
IT WASN'T UNIQUE TO THE NATIVE
INVESTIGATORS.
AS FAR AS THE DATA REPOS TO BE
SEE CONCERNED, FARCE I'M
CONCERNED, AS FAR AS THE FUNDING
OPPORTUNITY ANNOUNCEMENT
DESIGNED THIS IS GOVERNED BY THE
TRIBES, NOT BY NIH.
WE'RE NOT DEFINING THE DATA AND
HOW TO DO IT.
WE'LL BE THERE TO WORK WITH THEM
AND SUPPORT THEM, ON ALL THE
DECK CAL THINGS BUT IT IS VERY
CLEAR AND I THINK THAT'S UP WITH
OF THE, I WANT TO SAY THE
INNOVATIVE THINGS OR NEW THINGS
THAT CORRECT GOOD THINGS ABOUT
THIS IS IT IS SOMETHING THAT IS
EXPLICITLY SPELLED OUT TO BE NIH
SUPPORTED AND TRIBALLY GOVERNED
REPOSITORY BUT THE PROOF IS IN
THE PUDDING.
WE'LL SEE HOWS MAYBE IF A YEAR
WE'LL CALL ON YOU FOR HELP IF IT
LOOKS LIKE WE NEED SOME HELP.
>>THANK YOU FOR THAT.
AND I KNOW THAT YOU CAN'T
ANNOUNCE THE AWARDEE BECAUSE IT
HASN'T BEEN ANNOUNCED YET.
BUT ARE YOU ABLE TO SAY IF THIS
AWARD WENT TO A TRIBE OR AN
ACADEMIC INTEREST OR TRIBAL OR
ORGANIZATION?
I. NOT TRYING TO GUESS WHO IT
IS.
>>THANK YOU, VERY GOOD
QUESTIONS.
>>SO YOU MENTIONED THAT THE
REPOSITORY SUPPORTS TRIBAL
SOVEREIGNTY.
FOLLOWING THIS QUESTION AND THIS
IS JUST STARTING BUT HOW ARE YOU
THINKING ABOUT TRIBAL APPROVALS
AND BEFORE DATA IS ACCESSED AND
USED?
AND HOW ARE YOU WORKING THAT
INTO THE PROCESSES FOR USING THE
DATA AND SECOND, I'M CURIOUS
THAT YOU MENTIONED, RADX AND
THEN THE TEXT BUT HOW IS RADX
WORKING WITH THE TEXT BECAUSE
THAT IS A HOW ARE THE TWO
WORKING TOGETHER?
>>RIGHT,.
>>WHO IS GOING TO GET ACCESS TO
THE DATA AND HOW WILL IT BE
APPROVED IT'S ALL TO BE DECIDED
BUT WE'RE NOT GOING TO TELL THE
TEAM THAT RECEIVES THIS AWARD
HOW TO DO IT AND YOU CAN SAY
THEY'RE EXPERIENCED WORK WITH
TRIBAL ORGANIZATIONS AND THEY
WILL FOLLOW PROCESSES AND IT'S
ONE OF THE BETTER, THE GREATER
STRENGTHS OF THE INVESTIGATION .
INVESTIGATIVE TEAM.
WE'LL LEARN FROM THEM AS MUCH AS
THEY GET ASSISTANCE AND SUPPORT
FROM US AS WHAT IS NEEDED IN
TERMS OF STAYING WITHIN THE
FEDERAL GUIDELINES OR WHATEVER
IT IS WE NEED TO FOLLOW.
YOU IF ISSUE THE ON-LINE
APPLICATION AND THERE'S A GROUP
THAT DECIDES ONE WAY OR THE
OTHER.
YOU HAVE TO BUILD THE TECHNICAL
THING AND POSITIVE DATA.
THE SECOND ONE WOULD BE THAT SO
THE THIRD THING IT WILL TAKE AT
LEAST A YEAR AND TO GET TO THE
SPACE.
OK WE'VE GOT IT IT SET UP AND WE
CAN START ACCEPTING WE HAVE TO
BUILD IN AND IT'S 10 PROJECTS
NOT 100 AND WE HAVE THE TEAM AT
UC DUKE TO PROVIDE ADVICE AND
THEY'RE WAITING TO WORK WITH
WHOEVER THE AWARDEE IS AND SO WE
WILL LEARN FROM THIS AT NIH.
MUCH.
>>AS A FOLLOW-UP, I ASKED WAYS
WE AVOID ISSUES FROM HAPPENING
AT GRANTS STAGE AND THE
SUBMISSION PROCESS STAGE AND SO,
I WAS WONDERING AND REVIEWING
THE THE PROPOSAL FOR TRIBAL
NATIONS.
>>RIGHT.
SO, NIH HAS IT'S PROCESSES AND I
THINK THAT THERE'S ONLY SO MUCH
YOU CAN DEVIATE FROM THAT AND AS
WELL AS A WEBINAR SESSION OF
OPEN WEBINAR WHERE PEOPLE COME
AND ASK QUESTIONS AND THE THE
REVIEW IS DONE BY THE CENTER FOR
SCIENTIFIC REVIEW SO WE WERE NOT
INVOLVED WITH THAT AND CRITICAL
REVIEWS AND THEY WERE IN A
DECISION TO MAKE A FUNDING
SELECTION.
I THINK THAT'S AS MUCH AS, NOW,
IT WAS WRITTEN INTO THE PUBLIC
DOCUMENT AND YOU SHOULD HAVE
ACCESS TO.
THESE WERE ESSENTIAL CRITERIA
AND IN ORDER TO BE RESPONSIVE
AND COMPETITIVE FOR THIS
APPLICATION.
I WILL SAY, I DIDN'T WANT TO
MAKE SURE NOT TO IGNORE YOUR
SECOND QUESTION ON THE TEXT, I
DON'T KNOW IF THEY'RE PART OF
THE RADX-UP RECIPIENTS AWARD AND
IF THEY ARE, THEY'RE NOT PRIMARY
AND THERE MAY BE -- THEY'RE
COMPLETELY THEY'RE NOT
OVERLAPPING IN THAT REGARD SO
THESE ARE COMPLIMENTARY PROGRAMS
AND SHOULD NOT BE UP WITH
EXCLUDING THE OTHER.
THEY'RE BEEN AROUND AND
SUPPORTED.
RADX-UP WITH LIMITED TIME.
IT'S A FOUR-YEAR APPROPRIATIONS
AND AND COVID HAS EVOLVED.
NO ONE THINKS IT'S GOING TO GO
AWAY, IT WILL ENTER A
DIFFERENT -- IT'S IN A DIFFERENT
PHASE ALREADY.
I DON'T KNOW IF THAT HELPS OR
NOT.
I CAN FOLLOW-UP ABOUT THE
LINKAGE AND I'LL MAKE SURE STAFF
LET ME KNOW IF THERE IS IN AND
EVIDENCE WE CAN LET YOU KNOW, MY
NAME IS ALICIA MUZZO I'M THE
GREAT PLAINS DELEGATE.
YOU MAY HAVE MENTIONED IT, SO I
APOLOGIZE IF YOU DID, WHEN WILL
THE UNIVERSITY OF COLORADO GET
FUNDING AND STARTING TO ROLLOUT.
IT'S SUPER INTERESTING TO ME SO
I WANT TO BE ON TOP OF IT AND,
, READY WHEN THEY ARE READY.
>>LET ME MAKE SURE I
CLARIFY.
UNIVERSITY OF TORONTO GOT THE
TRIBAL EPIDEMIOLOGY RESOURCE
CENTER GRANT AND NOT THE TRIBAL
DATA REPOSITORY.
>>YES, THAT'S CORRECT.
I WONDERED WHEN THEY GOT THE
FUNDING FOR THE E EPIDEMIOLOGY.
>>IT STARTED IN JULY, I WANT TO
SAY.
I REMEMBER IT WAS THE MIDDLE OF
SUMMER WHEN THE AWARD LETTER
WENT OUT AND SO --
>>THANK YOU.
>>THAT WAS AN EASY ONE.
ANY FINAL COMMENTS?
>>AT LEAST I CANNOT SAY JULY.
SO YOU DO NOT MISS HEAR ME.
>>ANY FINAL COMMENTS BEFORE WE
LET Dr. PEREZ-STABLE OFF THE
HOOK HERE?
>>THANK YOU SO MUCH FOR JOINING
US.
I KNOW YOU'VE BEEN WAITING TO
SPEAK WITH US AND WE APPRECIATE
YOU TAKING TIME OUT OF YOUR DAY
AND WE KEEP THEM UPDATED ON THE
PROGRESS OF THIS INNOVATIVE.
CREDIT TABAK MENTIONED WE'RE
ACROSS THE AGENCY CONTINUALLY
DEVELOPING AND PUSHING THE
LIMITS OF INNOVATIVE IDEAS THAT
HAVE NEVER BEEN THOUGHT OF OR
EXECUTED BEFORE AND WE'RE DOING
THAT.
NOT ALL OF THESE WILL BE 100%
SUCCESSFUL EX WE WON'T DO IT IT
RIGHT THE FIRST TIME.
IT'S A LEARNING PROCESS AND IT'S
SOMETHING THAT WE SHOULD ALL
EMBRACE TOGETHER BECAUSE IT'S
IMPORTANT FOR US TO BUILD THAT
CRITICAL INFRASTRUCTURE CAPACITY
FOR TRIBES TO BE ABLE TO NOT
ONLY CONDUCT AND SUPPORT
BIOMEDICAL RESEARCH IN THEIR OWN
COMMUNITIES BUT TO ALSO THINK
ABOUT THEIR OWN AND CREATE THEIR
OWN PROJECTS AND IDEAS.
THANK YOU FOR JOINING US TODAY
AND WE APPRECIATE IT.
>>DAVE, I JUST WANT TO MAKE
SURE THE GROUP REALLY HEARS THAT
TRIBAL HEALTH RESEARCH OFFICE
AND SEPARATE AND IN OD BUT THIS
IS THE NIMHD, ONE OF THE
PRIORITIES AND OUR COMMITMENT
ADDRESSING THE HEALTH OF THE
AMERICAN INDIAN AND ALASKA
NATIVES TO INTERVENES TO
DECREASE AND HOPEFULLY ELIMINATE
SOME OF THE -- MANY OF THE
DISPARITIES WE OBSERVED, IS
REALLY A PRIORITY FOR US.
WE ARE NOT A PHYSIOLOGICAL
SYSTEM INSTITUTE AND WE COVER
ALL MINORITIES AND DISPARITIES
FOR THOSE GROUPS THAT WE HAVE
IDENTIFIED AND I THINK THIS IS
NOT SOMETHING THAT WE TAKE AS
SERIOUS AND IMPORTANT.
WE'RE HERE TO SUPPORT IT.
SO THANK YOU.
>>THANK YOU SO MUCH.
ALL RIGHT, WE'LL TURN IT BACK
OVER TO COUNCILMEMBER FRIAS.
>>OK.
THANK YOU SO MUCH FOR YOUR
PRESENTATION AND I DO APPRECIATE
IT IT.
NEXT WE HAVE -- I DIDN'T KNOW IT
WAS COMING OVER TO ME.
SO, NEXT WE HAVE PRESENTATION BY
Dr. BURGER AND -- AM I RIGHT?
NO.
SO Dr. MUDD.
>>YES, SHE'S WITH US.
I'M GOING TO TURN IT OVER TO
Dr. MUDD.
>>YES, HELLO.
THANK YOU.
GIVE ME A MOMENT TO SHARE MY
SCREEN.
CAN YOU SEE MY SLIDES?
>>YES.
>>GREAT.
>>WONDERFUL.
WELL THANK YOU SO MUCH, GOOD
AFTERNOON, EVERYONE.
AND THANK YOU TO THE TRIBAL
HEALTH RESEARCH OFFICE FOR IN
INVITING ME TO PRESENT TO YOU
TODAY ON THE LAUNCH NIH COM ON
FUND BRIDGE TO ARTIFICIAL
INTELLIGENCE OR BRIDGE TO AI
PROGRAM.
ON BEHALF OF MY PROGRAM
MANAGEMENT COLLEAGUE I'M HAPPY
TO PROVIDE AN OVERVIEW OF OUR
PROGRAM TODAY AND JUST TO SET
THE STAGE FOR THE BRIDGE TO ADD
PROGRAM WE ARE IN THE MIDST OF
AN ARTIFICIAL INTELLIGENCE OR AI
REVOLUTION AND WHERE AI IS
HOPEFULLY IMPROVING MANY ASPECTS
OF DAILY LIVES.
BUT WHAT ARE THE PROMISE OF AI
FOR BIO MEDICINE?
WELL SOME OF THE EARLY HINTS
INCLUDE NOT IMPROVED PROTEIN
PREDICTION AND THE BIOLOGY
REALM.
AS WELL AS MORE EFFICIENT
DIAGNOSIS OF DIFFERENT DISORDERS
AND BRIDGE TO AI IS SEEK TO GO
BUILD ON THESE SUCCESSES AND
ENHANCE THE ROLE OF THE
ARTIFICIAL I AM TELL AGAINST AT
AN INCLUSIVE, ETHICAL AND TRUST
WORTHY MANNER.
SO, JUST TO BRIEFLY MENTION HOW
WE GOT TO THIS POINT, A FEW
YEARS AGO, BASED ON THE
RECOMMENDATIONS OF AN EASTERLY
YEAR WORKSHOP, THE NIH MANY
DIRECTOR FORMED A WORKING GROUP
OF THE ADVISORY COMMITTEES TO
THE DIRECTOR TO LOOK INTO
ARTIFICIAL INTELLIGENCE AND
RELATED COMPUTATIONAL METHODS.
SOME OF THE RECOMMENDATIONS ARE
LISTED HERE.
FIRST, THE NERVES RE NIH HAS A F
DATASETS AND THEY WILL WORK WELL
FOR ARTIFICIAL INTELLIGENCE
ALGORITHMS AND GENERATING FLAB
SHIP DATASETS READY FOR
ARTIFICIAL INTELLIGENCE AND
A.I./ML TECHNIQUES.
SECONDLY NIH NEEDS TO INCREASE
EFFORTS TO ESTABLISH CRITERIA
FOR WHAT MAKES DATASETS AND
AI/ML READY.
THIRD, THAT THE USE OF AI NEEDS
TO BE GUIDED BY ETHICAL
PRINCIPLES WHEN APPLIED TO
BUYOLOGY AND MEDICINE AND THAT
NIH NEEDS TO PROVIDE LEADERSHIP
AND TO ATTRACT THOSE UNDERSTAND
AI, DATA SCIENCE AND BIO
MEDICINE AND NIH SHOULD CONVENE
CROSS DISCIPLINARY.
HOW CAN WE FACILITATE THESE AI
EXPERTS WORKING PRODUCTIVELY
WITH EYOLOGISTS AND CLINICIANS
AND SO THE BRIDGE O TO AI COMMN
FUND WAS INITIATE TODAY ADDRESS
THESE RECOMMENDATIONS, WE
ANNOUNCED FUNDING OPPORTUNITIES
LAST YEAR AND WE MADE AWARDS
THIS FALL AND ARE JUST NOW
KICKING OFF OUR CONSORTIUM.
THAT BRIDGE TO AI IS ONE OF THE
WORKING GROUPS AND WITH YOU I
MAY HAVE ALREADY BE TOGETHER
WORKING WITH THESE AI AT NIH.
S WE ARE LED BY INSTITUTES AND
CENTERS LISTED ON THIS SLIDE.
WE ARE COORDINATED BY THE COMMON
FUND.
WE ALSO HAVE THE PARTICIPATION
OF A LARGE WORKING GROUP.
WITH CONTRIBUTI COULDN'T OF MANR
FEDERAL ACTION THAT'S CONTRIBUTE
TO OUR PROGRAMS.
SO THIS THE GOAL OF BRIDGE TO
AI.
WE ARE LOOKING TO PROPEL BY OWE
MEDICAL RESEARCH FORWARD BY
SETTING THE STAGE FOR WIDESPREAD
ADOPTION OF ARTIFICIAL
INTELLIGENCE THAT CAN CACKLE
COMPLEX BIOMEDICAL CHALLENGES
THAT BEYOND HUMAN I HUMAN INNU .
IT IT WILL PREPARE AI READY
DATA.
THIS INCLU INCLUDES COMPLETE
BIOMEDICAL AND BEHAVIORAL
DATASETS THAT ARE FIND ABLE OF
COURSE ACCESSIBLE AND REUSABLE
OR FAIR.
AND CREATING SOFTWARE AND
STANDARDS TO UNIFY DATA ELEMENTS
ACROSS DIFFERENT DATA SOURCES
AND DATA TYPES AND SO THAT THEY
CAN BE BE EASILY USED BY AI
SYSTEMS.
WE ARE ALSO WORKING TO ENSURE
THAT THE DATA ARE ETHICALLY
SOURCED.
MEANING THEY'RE COLLECTED AND
USED IN AN ETHICAL MANNER AND
THE DATA ARE ACCURATE, RELIABLE
AND TRUST WORTHY.
AND FINALLY WE ARE FOCUSED ON
PROMOTING DIVERSE TEAMS TO
REALIZE THE POTENTIAL OF IA.
TEAM MEMBERS FROM SOCIAL,
ACADEMIC, INDUSTRY AND TECHNICAL
OR NON TECHNICAL BACK GROUNDS,
WILL COLLECT AND WORK WITH DATA
FOR RESEARCH PARTICIPANTS THAT
REFLECT THE DIVERSITY OF THE
UNITED STATES.
WE ARE ALSO WORKING TO CREATE
NEW TRAINING MATERIALS AND
ACTIVITIES TO SUPPORT WORKFORCE
DEVELOPMENT ACROSS DIFFERENT
RESEARCH COMMUNITIES.
SO OVER ALL, WE'RE REALLY HOPING
TO CREATE A SUSTAINABLE CULTURE
CHANGE THAT WILL FACILITATE
ARTIFICIAL INTELLIGENCE FOR
HEALTH RESEARCH AND DISCOVERY.
THESE ARE THE THREE PILLARS OF
OUR PROGRAM, DATA AND PEOPLE AND
ETH I GUESS WE WANT TO MAKE SURE
WE'RE ENGAGING A DIVERSE GROUP
OF PEOPLE NOT ONLY IN THE DATA
AND THE TEAMS COLLECTING THAT
DATA AND ETHICS AND WE WANT
ETHICS IN THERE OF OUR PROGRAM
TO MAKE SURE THAT WE ARE
REALLYEL CONSIDERING ALL THE
ETHICAL CHALLENGES OF THE USE OF
AI-ML TECHNIQUE FOR BIOMEDICAL
DISCOVERY AND INCORPORATING
NECESSARY PROTECTIONS AND SAFE
GUARDS.
SO IN THE COP TEXT OF SCIENTIFIC
DISCOVERY BRIDGE TO AI FOCUSED
ON THE DATA GENERATION AND
PREPARATION STAGE AND WE ARE
SUPPORTING SEVERAL DIFFERENT
DATA GENERATION PROJECTS EACH
STIMULATED BY DIFFERENT GRAND
CHALLENGE AND EACH OF THESE
PROJECTS INCLUDE THE SIX
MODULES, THAT YOU SEE ON THIS
SLIDE, THAT WILL WORK TOGETHER
TO GENERATE NEW AI/ML READY
DATASETS.
THESE DATASETS WILL BE MADE
PUBLICLY AVAILABLE AND THEY WILL
HOLD REGULAR DATA JAMBOREE AND
INVITE STAKEHOLDER COMMUNITIES
TO COME TOGETHER TO USE THE DATA
AND TAKE THE NEXT STEPS OF MODEL
DEVELOPMENT AND TESTING TO
ENABLE BIOMEDICAL AND BEHAVIORAL
SCIENCE DISCOVERY.
I WANT TO FOCUS ON THIS CENTER
BOX FOR JUST A MOMENT TO TALK
ABOUT THE SIX DIFFERENT MODULES
THAT WE REQUIRED FOR EACH OF OUR
DATA GENERATIONS PROJECTS.
WE HAVE ENGAGE EXPERTS FOR THEIR
DATA GENERATION PROJECTS.
SO FIRST IS THE TEAMING MODULE.
SECONDLY, THE ETHICAL INQUIRY
RATHER THAN JUST COMPLIANCE AND
NEXT THE STANDARDS MODULE AND IT
IT WILL BE WORKING TO UNIFY DATA
ATTRIBUTES ACROSS DATA SOURCES
AND TYPES AND THE TOOLS MODULE
THAT WILL BUILD AND PROVIDE NOT
SOFTWARE HARDWARE AND FIRM WARE
TOOLS AND THEM THE DATA
ACQUISITION MODULE THAT WOULD
ACTUALLYEL COLLECT DATA IF
GENERATE DATASETS BY
INCORPORATING THE TOOLS
STANDARDS AND ETHICAL AND TRUST
WORTHY PRINCIPLES DEVELOPED BY
THESE OTHER MODULES AND THE
SKILLS AND WORKFORCE DEVELOPMENT
MODULE WHICH WILL ENHANCE
SKILLED DEVELOPMENT AND ATTRACT
AND DEVELOP A NEW KIND OF INTER
DISCIPLINE AR HE'S AI AND ML AND
BEHAVIORAL RESEARCH WORKFORCE.
I WANT TO HIGHLIGHT THE ETHICS
COMPONENTS OF BRIDGE TO AI SINCE
THIS IS A IMPORTANT ASPECT AND
ONE OF OUR THREE PILLARS.
AS I SAID, THIS MODULE IS REALLY
FOCUSED ON INSTILLING A CULTURE
OF ETHICAL INQUIRY.
AND THIS IS IMPORTANT BECAUSE WE
RECOGNIZE THERE ARE POTENTIAL
HARMS OF ARTIFICIAL INTELLIGENCE
AND IT RAISES SOCIETAL CONCERNS
SUCH AS CONSENT TO THE
COLLECTION AND REUSE OF PERSONAL
DATA AND THE PROSPECTS THAT
HUMANS WILL HAVE LESS CONTROL
OVER HOW THESE TECHNOLOGIES ARE
DEVELOPED AND IMPLEMENTED.
SO, WITHOUT AN ETHICALLY ROBUST
SET OF PRINCIPLES AND PRACTICES,
THAT ARE GENERALIZABLE AND
REUSABLE, AI COULD REALLY
INFRINGE UPON PERSONAL RIGHTS
AND PERHAPS WIDEN GAPS AND
FAIRNESS EQUITIES.
TO IDENTIFY, ASSESS AND ADDRESS
ETHICAL ISSUES IN CREATING AND
DISSEMINATING A AYE/ML DATASETS
AND PROMOTE RESEARCH WITHIN
THESE COMMUNITIES SO EVERY
COMPONENT OF BRIDGE TO AI IS
REQUIRED TO HAVE THIS ETHICS
COMPONENT.
EACH PROJECTS WILL IDENTIFY AND
ADDRESS ETHIC CHALLENGES UNIQUE
TO THEIR PROJECTS AND WE'LL WORK
TO IDENTIFY SOME OF THESE CROSS
CUTTING ISSUES AND DEVELOP BEST
PRACTICES NOT FOR ADDRESSING
THEM.
THIS WILL BE AN ITERATIVE
PROCESS AS WE BUILD A LEARNING
COMMUNITY OF ETHICAL AND TRUST
WORTHY A.I.
ALL RIGHT, O THIS IS JUST AN SON
OVERVIEW.
WE HAVE FOUR DATA GENERATION
PROJECTS.
EACH FOCUSED ON A DIFFERENT
GRAND CHALLENGE PROJECT THAT
I'LL TALK ABOUT MORE IN A MOMENT
AND EACH INCLUDING ALL SIX OF
THOSE MODULES THAT I JUST TALKED
ABOUT.
OVERLAYING THESE INDIVIDUAL
PROJECTS WE HAVE ALREADY FUNDED
A BRIDGE CENTER WHICH WORKING
ACROSS THE DIFFERENT PROJECTS TO
COORDINATE THE ACTIVITIES OF THE
DIFFERENT MODULES AND MAKE THIS
INTO A TRUE CONSORTIUM WHERE
THEY CAN CONTRIBUTE TO BEST
PRACTICES.
THOSE WILL WORK ACROSS THE
PROJECTS TO FACILITATE INTER
DISCIPLINARY TEAM SCIENCE AND
INTEGRATE THE ACTIVITIES,
KNOWLEDGE, AND PRACTICES FROM
ACROSS THE DIFFERENT DATA
GENERATION PROJECTS AND
DISSEMINATE THOSE PRODUCTS AS
RESOURCES TO THE CONSORTIUM AND
STAKEHOLDER COMMUNITIES.
THEY WILL ALSO EVALUATE THE
BRIDGE TO AI PROGRAM AND THE
DEVELOPED PRODUCTS WITH INPUT
FROM EXTERNAL STAKEHOLDERS ON A
REGULAR BASIS.
AND OUR OVER ALL PURPOSE, IS TO
DEVELOP CROSS-CUTTING BEST
PRACTICES TO ENHANCE THE USE OF
AI/ML METHODS TO ADDRESS
BIOMEDICAL AND BEHAVIORAL
RESEARCH GRANT CHALLENGES.
SO, AS YOU CAN TELL FROM OUR
OVER ALL THE STRUCTURE, THIS
PROGRAM REALLY REQUIRES A BROAD
ARRAY OF SCIENTIFIC EXPERT TEASE
AS WELL AS INDIVIDUALS FROM
DIVERSE BACK GROUNDS TO COME
TOGETHER.
AND IN FACT, WE REQUIRED THAT
EVERY COMPONENT OF BRIDGE TO AI
INCLUDESSED A PLAN FOR ENHANCING
DIVERSE PERSPECTIVES.
SO INDIVIDUALS WITH DIVERSE
BACKGROUNDS AND LIFE EXPERIENCES
AND TRAINING IN DIFFERENT
DISCIPLINES, WILL BRING
DIFFERENT PERSPECTIVES AND
CREATIVITY TO ADDRESS THE
DIFFERENT SCIENTIFIC PROBLEMS WE
ENCOUNTER IN BRIDGE TO AI AND
THIS DIVERSITY WILL INCREASE THE
LIKELIHOOD THAT WE WILL SURFACE
CRITICAL, ETHICAL CONSIDERATIONS
THAT NEED TO BE ADDRESSED ACROSS
ALL ASPECTS OF THE PROGRAMMING.
SO, EVERY WARRANT HAS THIS PLAN
FOR ENHANCING DIVERSE
PERSPECTIVES THAT PROVIDES A
HOLISTIC VIEW OF HOW EP IT'S VID
AND SUPPORTED THROUGHOUT THE
PROJECT AND THIS IS JUST SOME OF
THE EXAMPLES ELEMENTS THAT EACH
OF THESE INCLUDE.
BY REQUIRING THE PLAN FOR
ENHANCING DIVERSE PERSPECTIVES
AND WE HOPE TO INSTILL A CULTURE
CHANGE WITHIN BRIDGE TO AI AND
ENHANCE DIVERSE PERSPECTIVE OF A
PART OF THE RESEARCH AND RIGHT
SEARCH TEAM.
SO THAT WE CAN PROVIDE
IDENTIFYING SOLUTIONS AND
COMBATING AGAINST BIASES AND
SUCH THAT WE'LL BE MORE
EFFECTIVE WITH OUR OVER ALL
OUTCOMES OF THE CONSORTIUM.
SO, NOW A FEW DETAILS ABOUT THE
AWARDS THAT WE'VE MADE AND WE
HAVE FUNDED THE BRIDGE CENTER
OUT OF THREE DIFFERENT
APPLICATIONS AND EACH INCLUDING
TWO DISTINCT COURSE, ADMIN AND
ETHICS, STANDARDS AND TEAMING
AND SCHOOLS AND TILLS AND
WORKFORCE DEVELOPMENT AND AS I
SAID WE FUNDED FOUR CAN I DATA
GENERATION PROJECTS AND OVER THE
NEXT FOUR SLIDES I WILL GIVE A
SNAPSHOT OF EACH OF THESE.
THE FIRST IS EXPANDING AI/ML IN
CLINICAL CARE.
THIS PROJECTS SEEKS TO CREATE A
DATASET OF 100,000 PATIENTS FROM
14 DIFFERENT INTENSIVE CARE UNIT
SITES ACROSS THE UNITED STATES.
SO IN THE ICU, PATIENTS ARE
HOOKED UP TO MULTIPLE MONITORS
THAT PROVIDES MUCH CONSTANT DATA
STREAMS ABOUT HEART RATE,
RESPIRATORY RATE, BLOOD PRESSURE
AND ET CETERA AND EXCEEDING
LEVELS OF ANY OF THESE MONITORS
WILL SET O OF THIS PROJECT IS
WORKING TOWARDS THAT END.
OUR NEXT PROJECT IS MORE
BIOLOGICAL AND RELATES TO
FUNCTIONAL GENOMICS.
AND THIS WILL MAP THE SPATIO
TEMPORAL ARCHITECTURE OF HUMAN
CELLS AND USE THE MAPS TO
UNDERSTAND THE CONNECTIONS
BETWEEN GENOTYPES AND
PHENOTYPES.
WHILE IN BIOLOGY, GENOTYPE
TRANSLATES TO PHENOTYPE.
WE DON'T KNOW MUCH BEEN THAT
PROCESS.
WE SEE DO KNOW IN BIOLOGY THAT
STRUCTURE TERMS FUNCTION SO IF
WE CAN USE THE STRUCTURALLAL
INFORMATION OF THE SELL WE CAN
ILLUMINATE THE CONNECTION THIS
TEAM WILL PROVIDE THREE MAPPING
APPROACHES AND THEY'LL CREATE A
LIBRARY OF LARGE-SCALE MAPS OF
CELLULAR STRUCTURE AND FUNCTION
WITHIN VARIOUS DISEASE CONTEXTS.
OUR NEXT PROJECT IS ON THE TOPIC
OF -- IF PATHOGENESIS IS IS
TRYING TO UNDERSTAND HOW DISEASE
AGAINST AND PROGRESSES THEN THIS
IS THE REVERSE.
TRYING TO UNDERSTAND HOW TO
REGAIN A HEALTHIER STATE OF AND
SO THIS TEAM HAS A TEMPORAL
ATLAS OF SALUTEOGENESIS AND
TYPE-2 DIABETES AS THEIR MODEL
DISEASE.
TYPE II DIABETES HAS SEVERAL
DIFFERENT LEVELS OF PROGRESSION
WITH A PRE DIABETIC STATE.
PERHAPS WE CAN USE DATA FROM
THIS PROJECT TO UNDERSTAND AMONG
PEOPLE WHO ARE PRE DIABETIC, CAN
WE PREDICT WHO IS GOING TO GO ON
TO DEVELOP FULL-BLOWN DIABETES
OR NOT.
OR FOR THOSE WHO ARE LATER
STAGES OF THE DISEASE, CAN WE
PREDICT THOSE WHO MAY BE ABLE TO
RETURN TO HEALTH AND RETURN TO
BEING PRE DIABETIC.
ONE UNIQUE ASPECT OF THIS
PROJECT IS THE TEAM MEMBERS
INCLUDE INDIVIDUALS FROM THE
DATA BANK CONSORTIUM AND WE'RE
WORKING WITH THEM ON WORKING ON
A NATIVE AMERICAN PARTNERSHIP
THROUGH TRIBAL CONSULTATION AND
WE'RE HOPEFUL TO GET STARTED ON
THAT PROCESS IN THE NEW YEAR.
AND THEN, FINALLY OUR FOURTH
PROJECT IT'S USING VOICE AS A
BIOMEDICAL MARKER FOR
RESPIRATORY DISORDERS, SLEEP
APNEA, MENTAL HEALTH AND
NEUROLOGICAL DISORDERS.
THEY'LL CREATING AND ANELLIZING
THOSE HOPE TO IDENTIFY BIOMARKER
SIGNATURES FROM THE SOUND WAVES
AND SO WE'RE ALL FAMILIAR WITH
THE SITUATION WHERE YOU TALKED
TO SOMEONE AND THEIR VOICE IS IN
THE BASEMENT AND YOU SAY OH, YOU
MUST HAVE A COLD, WELL, PERHAPS
THE VOICE HOLDS OTHER INDICATORS
OF HEALTH STATUS AS WELL AND
THIS PROJECT CERTAINLY HAS A LOT
OF TECHNICAL CHALLENGES AND
ETHICAL DILEMMAS INCLUDING VOICE
HACKING.
SO EACH OF THESE PROJECTS HAS
UNIQUE POPULATIONS AND DATA AND
AND WE'RE WORKING TO SEE HOW
THEY CAN COLLABORATE TOGETHER TO
FULFILL THE GOALS TO BRIDGE TO
AI AND SELECT FLAGSHIP DATA THAT
IS ETHICALLY SOURCED AND READY
FOR AI/ML ANALYSIS AND
DEVELOPING BEST PRACTICES FOR
DOING THIS WORK ETHICALLY WE'RE
WORKING TONE ABLE COLLABORATIONS
AND CONNECTIONS WITH AIM AHEAD
AND OTHER EFFORTS ACROSS NIH AS
WELL SO FOR EXAMPLE, TRYING TO
CROSS POLLENATE SKILLS AND
WORKFORCE DEVELOPMENT ACTIVITIES
AND PROMOTE I APPRECIATE YOUR
THOUGHTS AND HOW WE CAN ENGAGE
TRIBAL PARTNERS WITHIN BRIDGE TO
AI.
SO IN ORDER TO LEARN MORE, YOU
CAN GO TO OUR WEBSITE AND YOU
CAN SIGN UP FOR OUR LIST SERVE
AND ALSO E-MAIL US AND I THINK
I'LL STOP THERE AND STOP SHARING
MY SCREEN SO WE CAN ENTER INTO
DISCUSSION.
THERE IT IS.
OK.
THANK YOU VERY MUCH.
>>THANK YOU, Dr. MUDD FOR
YOUR PRESENTATION AND ALLOWING
TIME FOR SOME DISCUSSION AND
QUESTIONS.
SO, I'LL TURN IT OVER TO SEE IF
WE HAVE ANY QUESTIONS.
LET ME CHANGE MY GALLERY SO I
CAN SEE IF WE HAVE HANDS RAISED.
>>THANK YOU COUNCILWOMAN.
AT THIS FOR THAT PRESENTATION.
MY HEAD IS KIND OF SPINNING.
YOU KNOW, BECAUSE THIS IS, YOU
KNOW, WAY OVER MY HEAD AT THIS
POINT AND I'M STILL STRUGGLING
WITH SOME OF THE LARGE DATASETS
THAT NIH IS DEVELOPING AND
THINGS LIKE THIS AND TO THROW AI
AND MACHINE LEARNING INTO IT
COMPLICATES THINGS FOR ME
BECAUSE I'M NOT REALLY VERY WELL
EDUCATED AND AND I APOLOGIZE AND
QUESTIONS AND DON'T MAKE MUCH
SENSE AND REGARDING TRIBAL
CONSULTATION AND I KNOW YOU ARE
ENTERING INTO THAT RIGHT NOW AND
I THINK THERE'S GOING TO BE A
HUGE EDUCATION PIECE THAT WILL
HAVE TO GO TO BEFORE YOU CAN DO
TRIBAL CONSULTATION BECAUSE YOU
KNOW, I JUST DON'T KNOWS THAT
THAT KNOWLEDGE IS COMMONLY THERE
AND EVEN AMONG TECHNICAL
ADVISERS AND CERTAINLY NOT
AMONGST ALL TRIBAL LEADERS AND
SO, I DON'T KNOW HOW THAT IS
GOING TO HAPPEN AND I THINK THAT
PROCESS, YOU KNOW, IS GOING TO
REALLY TAKE SOME TIME.
I THINK TO MAKE SURE THAT PEOPLE
REALLY UNDERSTAND WHAT THIS
MEANS.
I GRASPED A LITTLE BIT OF IT.
I'M AN OLD ICU NURSE SO SOME YU
TALKED ABOUT WITH THE MONITORS
AND THAT MADE SENSE TO ME
BECAUSE YOU HAVE DATA IN THERE
AND I CAN SEE THAT CAN BE
GATHERED AND COLLECTED AND
UTILIZED AND SOME OF THESE OTHER
THINGS, MOSTLY HONESTLY I DON'TW
IT WORKS.
THE COP SENT AND ETHICAL ISSUES
AND THOSE TYPES OF THINGS AND --
AGAIN, I DON'T KNOW.
LIKE ANY KIND OF REPOSITORY
THOSE ARE ISSUES AND ACCESS TO
THIS DATA AND WHO CAN GET IT IT
AND WHAT IS IT USED FOR?
ALL OF THESE THINGS ARE JUST
CONSIDERATIONS THAT HAVE TO BE
MADE AND IT IT JUST TO ME ADDS A
WHOLE NEW DIMENSION.
JUST WHEN I THOUGHT I WAS
GETTING A GRASP I HAD ONE OF MY
COLLEAGUES THAT ASKED ME IF KNEW
I WAS ON THIS AND WANTED TO KNOW
IF I WAS AWARE OF THIS BRIDGE
TOP AI PROJECT AND OBVIOUSLY I
WASN'T AND I DON'T KNOW IF THE
TAC MEMBERS WERE EITHER.
THIS PERSON AND THIS INDIVIDUAL
SPECIFICALLY MENTIONED AS FAR AS
AMERICAN INDIAN AND DATA GOES
THERE IT STARTED IN THE 80s
AND 90s AND INCORPORATED THAT
DATA INTO THIS SO AGAIN, I DON'T
KNOW IF IF YOU HAVE ANY
KNOWLEDGE OF THAT AND OR JUST --
I THINK IT WILL TAKE EDUCATION
FOR TO FIGURE OUT HOW TO GRASP
ETHICAL CONSIDERATIONS FOR THIS
TYPE OF WORK AND PARTICULARLY
WITH AMERICAN INDIAN AND ALASKA
NATIVE DATA WHICH WE'RE STILL
GRAPPLING WITH ALL OF US AND
THINGS LIKE THAT.
THANK YOU FOR YOUR TIME AND
APPRECIATE IT.
>>ABSOLUTELY.
I REALLY APPRECIATE ALL OF THOSE
COMMENTS AND I GUESS, ONE THING
I'LL JUST SAY IS I AM NOT AN
ARTIFICIAL INTELLIGENCE EXPERT
EITHER AND THIS WAS THE
COMPLETELY NEW FIELD FOR ME WHEN
I JOINED THE PROJECT A COUPLE
YEARS AGO AND I HAVE JUST
LEARNED A LOT ABOUT THE
POTENTIAL PROMISE OF THESE
TECHNIQUES FOR REALLY ADVANCING
OUR UNDERSTANDING OF DISEASE ASK
HOW TO TREAT DISEASE AND IMPROVE
INDIVIDUAL'S HELP SO I HOPE THIS
ENDEAVOR CAN REALLY MAKE HUGE
IMPROVEMENTS AND I THINK OF THAT
YOU HIT THE NAIL ON THE HEAD IN
TERMS OF THE NEED FOR EDUCATION
AND AND CAPACITY BUILDING AND
IT'S A HUGE PART OF WHAT WE'RE
TRYING TO DO WITH THE SKILLS AND
WORKFORCE DEVELOPMENT ASPECTS
AND THAT WERE REQUIRING ACROSS
ALL THE PROJECTS AND WELCOME
BACK THE CONSORTIUM AS A WHOLE
AND THAT'S ONE THING THAT WE'RE
REALLY WORKING TOGETHER WITH AIM
AHEAD AS WELL TO MAKE SURE THAT
THOSE OPPORTUNITIES ARE
EXPLICITLY ADVERTISED AND
RECRUIT SO THAT WE CAN BRING
THOSE ASPECT AND THAT CAPACITY
BUILDING TO EVERYONE.
I ALSO APPRECIATE YOUR COMMENTS
ABOUT THE NEED FOR EDUCATION TO
EVEN UNDERSTAND THE ETHICAL
CONSIDERATIONS AND WE'RE WORKING
TOWARDS DOING THAT AS WELL.
I'M AND SO HOPEFULLY THE
DATASETS WILL INTERFACE IN THE
FUTURE BUT ALL FOR ALL THOSE
COMMENTS I APPRECIATE IT IT.
>>AND JUST THINK FOR THAT AND
ONE FINAL AND I KNOW WHEN I WAS
LOOKING AT YOUR PRESENTATION AND
THE GROUP LIKE THIS FOR ME, I
THINK OF AMERICAN INDIAN WHEN I
SEE AI.
>>I WAS TRYING TO SAY
ARTIFICIAL INTELLIGENCE AND UP
WITH OF THE THINGS ABOUT AN
EDUCATION PIECE WE'VE BEEN
WORKING CLOSELY WITH THE HIGHER
EDUCATION CONSORTIUM AND
PROVIDING PRESENTATIONS MULTIPLE
REPRESENTATIONS TO THE TCU
PRESIDENTS SO THAT THEY CAN BE
MORE FAMILIAR WITH AND WHAT THE
POWER COULD BE AND THE
POSSIBILITIES, IT'S IMPORTANT TO
THINK ABOUT THIS AS HE
PREDICTIVE INSTRUMENT AND
SOMETHING WHERE WE MIGHT TO
IDENTIFY RARE DISEASES IN OUR
COMMUNITY AND WITH USING LARGE
DATASETS SO THAT'S ANOTHER
POWERFUL POINT OR PART OF AI
THAT WE SHOULD BE CONSIDERING SO
THE EDUCATION PART IS SOMETHING
THAT WE'RE HOPING TO COLLABORATE
WITH AM AND BRIDGES TO AI EX IN
THE FUTURE.
THANK YOU.
>>THANK YOU.
WE HAVE ANOTHER QUESTION.
>>YES, THANK YOU FOR YOUR
PRESENTATION, Dr. MUDD I'M THE
ALBUQUERQUE AREA DELEGATE AND I
JUST WANTED TO COMMENT WHEN IT
CAME TO YOU HAD MENTIONED THE
FAIR PRINCIPLES WHEN IT COMES TO
MAKING DATA FINDABLE AND
ACCESSIBLE AND INTEROPERABLE AND
REUSABLE AND I WAS JUST
WONDERING IF YOU HAD AN
OPPORTUNITY TO LOOK AT THE CARE
PRINCIPLES BECAUSE IT'S APP
IMPORTANT, ESPECIALLY WHEN YOU
ARE GOING TO BE DOING THE PIECE
WHEN IT COMES TO CAPACITY
BUILDING AND WHEN IT IT COMES TO
TRIBAL CONSULTATIONS AND I THINK
THAT WOULD BE IMPORTANT AND TO
DEMONSTRATE HOW YOU ARE LOOKING
AT INCORPORATING THE CARE
PRINCIPLES AND AGAIN, FOR THOSE
WHO ARE NOT AS FAMILIAR WITH THE
CARE PRINCIPLES IT'S REALLY I AM
TIGE GOV YOUR WORSHIPPANCE
PRINCIPLES THAT WERE DEVELOPED
BY THE INDATA SOVEREIGNTY
SPECIAL INTEREST GROUP AT RIGHT
SEARCH DATA ALLIANCE WHO
DEVELOPED THE PAIR PRINCIPLES
AND SO THE INDIGENOUS GROUP CAME
UP WITH THE PRINCIPLES TO
COMPLIMENT TO RIGHTS AND CENTERS
AND DATA ARE ALSO RECOGNIZED
IT'S COLLECTIVE BENEFIT AND
CENTS TO IMPORTANT THAT WE
REALLY LOOK AT OUR OWN ETHICAL
FRAMEWORK BASED ON WHERE WE COME
FROM AND SOMETIMES MY
UNDERSTANDING MAY DIFFER BECAUSE
I'M A PUEBLO INDIAN WOMAN AND IT
DOESN'T ALIGN WITH A WESTERN
VALUE SYSTEM SO IT'S A IMPORTANT
PART OF THE CONVERSATION BECAUSE
I THINK THAT THE TERM ETHICS
MEANS DIFFERENT THINGS TO
DIFFERENT PEOPLE SO THANK YOU
AGAIN FOR YOUR PRESENTATION.
>>YES AND THANK YOU FOR THOSE
COMMENTS AND FOR BRINGING THAT
UP AND I REALLY AM SORRY I
DIDN'T I AM CONCLUDE THAT IN THE
PRESENTATION AND OUR ETHICS IN
THE BRIDGE CENTER THAT IS GOING
TO BE WORKING TOWARDS REALLY
IT'S BE FAIR EX CARE AND THEY'RE
INCORPORATING BOTH THE FAIR AND
CARE PRINCIPLES AND WORKING
THROUGH AND WHAT IT MEANS IN
THIS SPACE SO IT'S A CRITICALLY
IMPORTANT ELEMENT AND I
APOLOGIZE FOR NOT INCLUDING IT
IN MY SLIDES.
THANK YOU FOR BRINGING IT UP.
>>Governor Inslee: DO WE HAVE
ANY OTHER QUESTIONS?
>>I JUST HAVE ONE FURTHER
COMMENT.
YOU KNOW.
FOR SEVERAL YEARS NOW WE'VE BEEN
WORKING WITH A LOT OF THESE BIG
DATA PROJECTS AND PARTICULARLY
I'M THINKING OF IN MIND A
PRECISION MEDICINE AND RESEARCH
AND REALLY TARGETED MEDICINE AND
AND TO MY KNOWLEDGE THAT HASN'T
REALLY BLOSSOMED TO WHERE WE
THOUGHT IT IT WOULD BE SEVERAL
YEARS AGO SO I JUST MADE IT A
CAUTIONARY NOTE THAT THE
PROJECTS LIKE THIS THAT
HOPEFULLY ARE PROMISING AND THIS
IS THE WAVE OF THE FUTURE AND
THESE ARE THE THINGS THAT WILL
TRANSFORM HEALTHCARE AND
MEDICINE AND IT HASN'T REALLY
HAPPENED.
O, JUST I TAKE THOSE OF US WHO
HAVE BEEN AROUND A WHILE ARE
KIND OF MINDFUL OF SOME OF THOSE
PAT EXPERIENCES.
THANK YOU.
>>THANK YOU FOR THAT COMMENT
AND WE APPROACH BRIDGE TO AI
ITSELF AS AN EXPERIMENT AND THE
WAY THAT WE'RE COMBINING THESE
DIFFERENT AREAS OF EXPERTISES AS
AN EXPERIMENT AND WE HOPE TO
LEARN A LOT FROM THE PROCESS AS
WELL AS THE OUTCOMES.
YES.
>>THANK YOU I APPRECIATE THAT.
AND THANK YOU FOR YOUR
PRESENTATION.
THE INFORMATION YOU PROVIDED E.
IT WAS VERY DENSE AND YOU WEPT
THROUGH IT IT VERY QUICKLIES.
I DID LOOK FOR IT ON OUR DROP
BOX BUT WHEN WE GET A CHANCE TOP
REALLY LOOK AT IT THERE THERE'S
ANOTHER OPPORTUNITY TO ABOUT
OVER THIS AGAIN BECAUSE I THINK
IT IS REALLY IMPORTANT FOR US O
TAKE A LITTLE BIT MORE TIME TO
HAVE A LITTLE BIT MORE
DISCUSSION AND AFTER WE HAVE
TIME TO REVIEW IT AND MOVE ON.
>>I'M SHARE MY SLIDES.
>>THANK YOU, VERY MUCH.
>>THANK YOU.
WE'LL MOVE ON TO OUR NEXT
PRESENTERS.
AND WE HAVE Dr. BERGER AND
Dr. HULL WHO HAD PRESENT ON
NIH POLICIES, PROTECTIONS AND
IMPLICATIONS AND FOR THE ETHICAL
CONDUCT OF RESEARCH WITH TRIBAL
COMMUNITIES INCLUDING GENETIC
RESEARCH.
SO, IT THANK YOU Dr. HULL EX
Dr. BERGER FOR BEING HERE
TODAY AND I APPRECIATE, WE ALL
APPRECIATE IT AND THANK YOU
ESPECIALLY Dr. HULL FOR
JOINING US IN OUR MEETINGS AND
REALLY LISTENING TO THE TOPICS
AND BEING ABLE TO WORK WITH US
IN OUR AGENDA TO HIGHLIGHT THE
AREAS THAT ARE IMPORTANT TO TACK
AND WHAT IS HAPPENING IN
RESEARCH IN INDIAN COUNTRIES AND
ALASKA SO WHICH REALLY
APPRECIATE IT IT AND WE ARE
LOOKING FORWARD TO YOUR
PRESENTATION.
>>THANK YOU.
WE'LL GO AHEAD AND SHARE MY
SLIDES HERE.
THE SLIDE SHOW I HAVE UP.
BEAR WITH ME FOR ONE SECOND.
>>MY NAME IS ADAM BERGER AND
I'LL KICK US OFF BEFORE I TURN
IT OVER TO Dr. HULL AND WE'RE
GOING TO GO BACK AND FOURTH IN
THIS TALK AS WELL SO YOU WILL
HEAR FROM BOTH OF US IN VARIOUS
POINTS AND I DO WANT TO START
OUT AND SAY MY NAME IS IS ADAM
BURGER AND I'M THE DIRECTOR OF
CRITICAL AND HEALTHCARE RESEARCH
IN THE OFFICE OF SCIENCE POLICY
AND I WOULD LIKE TO GIVE A BIG
THANKS TO Dr. WILSON AND ALL
THE TAC MEMBERS FOR THE INVITE
AND THE OPPORTUNITY TO SPEAK TO
YOU TODAY.
OUR TALK IS GOING TO BE
HISTORICAL REVIEW FOR POLICIES
AND LEADING INTO SOME
CONTEMPORARY RESEARCH AND
PRACTICES THAT WE HAVE ON GOING
AND WE'LL SHIFT OVER TO CONCEPT
AND GENOMIC DATA SHARING AS WELL
AS DEALING WITH SOME OF THE DATA
MANAGEMENT AND SHARING POLICIES
AND ACTIVITIES THAT WE'VE HAD
GOING ON RECENTLY THAT YOU HEARD
FROM DR. TABAK AND THEN ENDING
ON THE IMPORTANCE OF INCLUSION.
>>AND OVERSEEING PRESIDENT
OMICRON AND CROSS ALL OF HHS BUT
YOU KNOW, I WILL SAY IT'S REALLY
THE STORY OF THAT SPEAKS TO MY
INTEREST IN INSURING PROTECTIONS
FOR BOTH RESEARCH PARTICIPANTS
AND PATIENTS AND I'M NOT GOING
TO GO INTO IT TODAY, BUT JUST
BECAUSE WE HAVE A LOT TO COVER
BUT IT'S A TALE WITH
UNFORTUNATELILY DEADLY
CONSEQUENCES BECAUSE THERE
WEREN'T ADEQUATE PROTECTIONS IN
PLACE.
IT DID LEAD TO CHANGE FOR THE
BETTER.
IT'S ONE OF THE THINGS WE NEED
TO REMEMBER ABOUT WHAT WE CAN
LEARN FROM THE PAST AND IT'S
THIS CONCEPT OF NEVER FOR
GETTING OUR PAST THAT WE CAN
ALWAYS DO BETTER IN THE PRESENT
AND IT SPEAKS TO ME AND I THINK
THIS QUOTE FROM GEORGE CAPTURED
THAT PERFECTLY.
IF YOU DON'T REMEMBER THE PAST
YOU ARE GOING TO BE CONDEMNED TO
REPEAT IT IT.
AS I NOTED, WE'RE GOING TO GIVE
SORT OF A HISTORICAL WALK
THROUGH ON RESEARCH PROTECTIONS
AND SOME OF THE PAST EVENTS THAT
WE'LL QUICKLY COVER.
AND HOW THEY SHAPE THE
PROTECTIONS THAT WE HAVE TODAY.
WE'LL STARRED IN 946 THIS IS THE
END OF WORLD WAR II.
AND -- 1946.
ON TRIAL ARE 23 PHYSICISTS AND
PHYSICIANS TRIED FOR WAR CRIMES
AND CRIMES AGAINST HUMANITY AND
I CAN'T THINK OF A BETTER WAY TO
DESCRIBE WHAT WE'RE TALKING THAN
JUST TO QUOTE THE CHARGES
DIRECTLY AND THE CHARGES IN THIS
CASE WERE COMMITTING MEDICAL
EXPERIMENTS WITHOUT CONSENT AND
THOSE COMMITTED MURDERS,
BRUTALITY, CRUELTY AND OTHER
INHUMAN ACTS.
MANY VICTIMS SUFFERED AGONY,
PERMANENT DISABILITY,
EXPERIMENTS CAUSED PAIN AND
SUFFERING AND RESULTED IN
SERIOUS BODILY INJURIES TO THE
VICTIMS.
AND THE CHARGES GO ON.
THEY DID LEAD TO THE DEVELOPMENT
OF THE NEWERREN BERG CODE WHICH
IS THE FIRST INTERNATIONAL CODE
OF RESEARCH ETHICS AND
PARTICIPATION AND THIS IS IS OUR
DEVELOPED IN 1948 AND WHAT IT
REALLY GOES DOWN AND YOU HAVE TO
GET COP SENT AND OF IT MUST BE
VOLUNTARILY PROVIDED AND YOU
HAVE TO JUSTIFY THE
SUPERVISORMENTS AND AND WE'RE 14
YEARS INTO THE U.S.
PUBLIC-HEALTH SERVICE CONDUCTING
THE EXPERIMENT AND THIS WENT ON
TO BE A 40-YEAR EXPERIMENT.
400 BLACK MEN INFECTED WITH SEV
LUS WERE NEVER TOLD THEY HAD THE
DISEASE AND WHAT IT CAN DO TO
THEM NOR WERE THEY GIVEN
TREATMENTS WHEN IT WAS
AVAILABLE.
THE MEN BELIEVE THEY WERE IN A
GOVERNMENT STUDY AND THE STORY
AT THE END OF THE DAY IS ONE OF
EXPLOITATIONS AND DECEPTION AND
WITHHOLDING OF TREATMENT AND
LACK OF INFORMED CONCEPT AND ALL
IN THE NAME OF SCIENCE.
AND 100 OF THOSE GENTLEMAN DIED.
AND THIS REALLY IS A DISTRUST OF
THE BIOMEDICAL RESEARCH PRIZE
THAT LINGERS TO THIS DAY,
STATEMENT THE NEWERRENBERG
TRIALS ARE GOING ON WE HAVE THE
GUATEMALA STUDIES AND IT'S 1946
TO 1948 AND THE STUDY OF BIO
ETHICAL ISSUES WROTE A REPORT ON
THIS AND SO I WON'T GO DEEPLY
INTO DETAILS AND THE U.S. AND IN
THIS CASE, THEY WERE
INTENTIONALLY EXPOSING AND THE
STD WITHOUT AND IN THIS CASE,
THESE WERE SOME OF THE MOST
VULNERABLE AND PRISONERS AND
MILITARY AND THEY WERE
PSYCHIATRIC PATIENTS AND OTHERS.
IT INCLUDED IT BECAUSE IT HAS A
DIRECT CORRELATION AND WHERE
INFO CONSENT COMES INTO PLAY IN
THE UNITED STATES.
AND THIS IS IMPORTANT TO NOTE
THAT IT WAS CREATED AND MARKETED
IN EUROPE FOR MORNING SICKNESS
AND IT ENDED UP CAUSING SEVERE
BIRTH DEFECTS AND DEATHS IN
BABIES BUT IT WAS NEVER ACTUALLY
MARKETED HERE IN THE U.S. AND IT
WAS NEVER APPROVED FOR USE HERE
IN THE STATES.
BUT, SAMPLES WERE ACTUALLY SENT
TO U.S. DO DOCTOR OF PATIENTS AD
THEY WERE NEVER TOLD IT WAS
EXPERIMENTAL SO AT THE END OF
THIS, WHILE IT WASN'T AS MANY
PATIENTS AS YOU FOUND IN YOUR UP
AYOUR WORSHIP UP AND ELSEWHERE
BABIES WERE BORN IN THE U.S.
BECAUSE OF THIS APPROVED
EXPERIMENTATION AND WHAT IT
LEADS TO AND AGAIN COMING BACK
TO CONCEPT OF TRYING TO LEARN
WHERE DOES IT BRING US TODAY, IT
LED TO THE 1962 AMENDMENTS THAT
THE FEDERAL FOOD AND DRUG
COSMETIC ACT AND IT REALLY
CODIFIED NOW IT WAS A
REQUIREMENT IN THE U.S. FOR DRUG
TRIALS AND THE NEWERRENBERG CODE
WAS THE FIRST CODE TO ADVOCATE
FOR INFORMED CONSENT BUT HERE IN
THE U.S. IT'S A AMENDMENTS THAT
WERE THE FIRST LAW TO REQUIRE
IT.
GOING FORWARD, YOU GO TO 1964
AND HEALTH SAY TEE AND IT LAYS
OUT THE BASIC PRINCIPLES FOR
PHYSICIAN INVOLVEMENT OR
RESEARCH AND YOU NEED TO
ACTUALLY HAVE EXPERIMENTATION ON
ANIMALS OF YOU MOVE INTO HUMANS
AND THE RESEARCH HAS TO BE
REVIEWED BY AN INDEPENDENT BODY
BEFORE IT'S CONDUCTED ASK
QUALIFIED INDIVIDUALS THAT ARE
CONDUCTCONDUCT THE EXPECTMENT AH
THE BENEFIT AND RISK OF THE
ACTUAL EXPERIMENT ITSELF AND YOU
HAVE TO RESPECT PARTISAN PRIVACY
AS WELL AS THE VOLUNTARY AND USE
OCONSENT.
THE INTERESTING THING AND THE
MINORS AND ABLE TO GIVE IN
ADDITION TO THE LEGAL GUARDIAN
AND ANIMAL WELFARE AS WELL SO
YOU ARE SEEING A MUCH MORE
ROBUST OVERSIGHT FRAMEWORK HOW
YOU CONDUCT RESEARCH IN THE U.S.
AND TAKE PLACE.
AND THERE WERE OTHER
DEVELOPMENTS, 1966, SURGEON
GENERAL EVEN BEFORE 966 BEFORE
ANY OF THESE THEY HAVE A METH
CAL RESPONSIBILITY TO RESEARCH
MEDICAL CARE AND IN 1963, 1966
WHERE YOU GET FDA REGULATIONS
COMING INTO PLAY AND SO YOU
KNOW, ALL OF THIS TAKES IN PLACE
AND THEIR CHANGED TO IDENTIFY
THE BASIC ETHICAL PRINCIPLES
THAT SHOULD UNDERLINE THE
CONDUCT OF THE BEHAVIOR AND
BIOMEDICAL RESEARCH WITH HUMAN
BEINGS AND THE OTHER THING THAT
THEY WERE CHARGED WITH WAS
DEVELOPING GUIDELINES THAT
SHOULD BE FOLLOWED TO ASSURE
THAT THE RESEARCH ITSELF IS
CONDUCTED IN ACCORDANCE WITH SET
PRINCIPLES AND THAT COMMISSION
IS WHAT IS IS THE ONE THAT
ACTUALLY ISSUED WHAT IS KNOWN AS
THE BELMONT REPORT.
THE BELMONT REPORT COMES OUT IN
1979 PROVIDING A FRAMEWORK THAT
WOULD GUIDE THE RESOLUTION TO
ETHICAL PROBLEMS FROM RESEARCH
AND IT CAME OUT WITH THREE BASIC
PRINCIPLES FOR THE ETHICAL
CONDUCT OF RESEARCH.
THESE PRINCIPLES ARE RESPECT FOR
AMERICANS AND BENEFITS AND
JUSTICE AND THEIR APPLICATION
COMES OUT OF THE CONCEPTS OF
INFORMED CONSENT AND RISK AND
BENEFITS BEING SYSTEMATICALLY
ASSESSED AND THE OTHER THING
THAT THE BELMONT REPORT DID IS
HIGHLIGHTS THE NEED FOR
INJUSTICE AND DISPARITIES AND
IT'S REALLY IMPORTANT FOUNDATION
APPROACH FOR US AS A SOCIETY TO
MOVE TOWARDS RESEARCH
PROTECTIONS.
SO, THAT LED DIRECTLY INTO THE
COMMON RULE SO THIS IS WERE IN
1981, THE DEPARTMENT OF HEALTH
EDUCATION OF WELFARE AND THE
F.D.A. REVISED OUR HUMAN
SUBJECTS REGULATIONS TAKING INTO
ACCOUNT THAT FOUNDATION AND THE
PRESIDENT COMMISSION CALLED FOR
THE ADOPTION OF THESE
REGULATIONS BY ALL FEDERAL
AGENCIES AND CONDUCTING
RESEARCH.
SO IN 1991, WHICH IS ONE OF THE
COMMON RULES IS ADOPTED AND THEY
ADOPT THE COMMON RULE AND TODAY
THAT NUMBER IS 20 DEPARTMENTS IN
THE AGENCIES AND THE COMMONER
OUTLINES BASIC PROVISIONS FOR
IRBs AND INFORM CONSENT AND
ASSURANCE OF COMPLIANCE.
NOW, A COUPLE OF POINTS AND I
WANT TO START THIS OUT AND AT
NIH WE DON'T HAVE THE COMMON
RULE THAT IS OVER SEEN BY THE
HHS OFFICE FOR HUMAN PROTECTION
AND SO I'M JUST QUOTING IS
DIRECTLY IN THE TAX ITSELF AND
WHAT DOES THIS POLICY APPLY TO
AND I'LL GIVE YOU MY TAKE ON
THIS REALLY IS THAT, YOU KNOW,
IT'S AND IF YOU HAVE A TRIBAL
LAW PASSED BY THE BODY AND
AMERICAN AND ALASKA NATIVE
CHILDREN AND THERE'S NO GO ABOVE
AND BEYOND AND IT'S A MINIMUM.
ONE OF THE OTHER PIECES IS A
THERE HA HAS BEEN REQUIREMENT TO
HARMONIZATION AND BETWEEN THE
FDA REQUIREMENTS AND THE
COMMONWEALTH AND SO THE EXTENT
PRACTICE TICK ABLE AND THAT
COMES OUT OF THE THE 21 CENTS
RECURES ACT AND REQUIRING THIS
AND JUST RAISING TO NOTE THAT
FDA RECENTLY PUT OUT TO WE DON'T
OVERSEE THIS HERE AT NIH AND
WHERE THESE DIFFERENT
PROTECTIONS ARE AND I JUST
WANTED TO RAISE IT TO ALL OF YOU
TO MAKE YOU AWARE THAT THESE ARE
OUT THERE AND THEY'RE ALL-OUT
FOR PUBLIC COMMENT.
THERE'S A QUESTION THAT FDA
OPPOSED WHERE THEY'RE ASKING
WHETHER IT'S APPROPRIATE TO
RESEARCH FOR WHICH USE OF A
SINGLE IRB TO MEET THE NEEDS OF
THE SPECIFIC POPULATIONS.
THAT'S THE STATE OF THE CURRENT
RULE ITSELF AND I DID -- I DID
WANT TO SPEAK A LITTLE BIT MORE
SPECIFICALLY ABOUT THINGS THAT
WE HAVE GOING ON AT NIH AND IN
THIS CASE I WANT TO SHIFT OVER
TO SINGLE IRB HERE AS WE
IMPLEMENTED IT AND THE BENEFITS
THAT WE WERE LOOKING AT FOR THE
SINGLE IRB FOR RESEARCH IS
SINGLE IRB TO ENHANCE AND
STREAMLINE THE REVIEW PROCESS
AND NECESSARILY IRB REVIEW AND
IT COULD REDUCE ADMINISTRATIVE
BURDENS AND SYSTEMIC
INEFFICIENCIES IN THE PROCESS.
SO WE ACTUALLY DEVELOPED OUR
SINGLE IRB POLICY AND PUT IT OUT
IN DECEMBER OF 2014 AND THERE
WERE 167 COMMENTS RECEIVED ON
THIS AND FROM A WIDE RANGE OF
STAKEHOLDERS INCLUDING TRIBAL
NATION REPRESENTATIVES AND
TRIBAL NATION COMMENTERS AND
POINTED AND IMPORTANCE OF
FIRSTHAND KNOWLEDGE AND LOCAL
TRIBAL SYSTEMS AND CULTURAL
VALUES AND TRIBAL SENSITIVITIES
AND ALSO AND TO SEE THAT AS WELL
SO, WITH THAT I'M GOING TO TURN
THE TALK OVER TO Dr. HULL WHO
WILL TAKE US THROUGH MORE OF THE
CONTEMPORARY RESEARCH PROTECTION
AND AGAIN LIKE I SAID WE'LL BE
THROWING THIS BACK AND FOURTH TO
EACH OTHER.
ED THANK YOU FOR THIS DISCUSSION
AND IT'S REALLY JUST BEEN SUCH A
PLEASURE WORKING TOGETHER WITH
YOU AND YOUR TEAM AND THE NIH
OFFICE OF SCIENCE POLICY AND A
SUSTAINED WAY ON THE NUMBER OF
THE TOPICS THAT WE'RE TALKING
ABOUT TODAY.
AND THANK YOU ALL TO THE TECH
FOR THIS GENEROUS TIME SLOT ON
YOUR VERY FULL AGENDA.
NEXT SLIDE, PLEASE.
I WOULD LIKE TO START WITH A BIT
OF BACKGROUND FROM MY PART OF
THE PRESENTATION.
REALLY MY ENTIRE CAREER AT THE
NIH WAS INFLUENCED BY A VERY
UNIQUE EXPERIENCE.
FOR PRESIDENT CLINTON ADVISORY
COMMITTEE ON HUMAN RADIATION
EXPERIMENTS.
WHICH WAS CHARGED WITH TELLING
THE TRUTH ABOUT ALSO FOR
INSURING OUR CURRENT DAY
RESEARCH POLICIES AND PRACTICES
ARE ADEQUATE TO ENSURE WE DON'T
REPEAT THOSE MISTAKES OF THE
PAST AND THIS PHOTO, WHICH
UNFORTUNATELY, I GUESS WAS TAKEN
BEFORE SELFIE STICKS WERE
INCONVENIENTED, BUT IT SHOWS AT
LEAST HOW CHOSE I WAS SITTING TO
THE STAGE AT THE CEREMONY WHERE
THE FINAL REPORT WAS PRESENTED
TO PRESIDENT CLINTON AS WELL AS
TO ATTORNEY GENERAL JANET RENO
AND THEY WERE COMPREHENSIVE IN
THEIR DOCK TAKE OF RESEARCH THAT
HAD BEEN CONDUCTED INCLUDING
OBSERVATIONAL STUDIES MANY OF
WHOM WERE NAVAJO AS WELL AS
RADIOACTIVE IODINE AND ALASKA
NATIVE PEOPLE.
MY OWN PERSONAL ROLE WAS FOCUSED
ON THE PREP DAY CONTEXT OF
RESEARCH REGULATIONS AND OF
RESEARCH PARTICIPANTS
EXPERIENCES BUT I THINK THAT THE
MOST STRIKING THING ABOUT THAT
DAY AND THAT PROBABLY
CHARACTERIZES MY ENTIRE
EXPERIENCE, NEXT SLIDE, PLEASE,
WAS HEARING PRESIDENT CLINTON
APOLOGIZE AND TAKE
RESPONSIBILITY ON BEHALF OF THE
FEDERAL GOVERNMENT AND A FUTURE
OF THE GOVERNMENT AND NEXT
SLIDE, THIS PROVIDED A BLUE
PRINT FOR THE APOLOGY HE OFFERED
A FEW YEARS LATER TO THE BLACK
MEN WOULD WERE THE VICTIMS OF
THE U.S. PUBLIC-HEALTH SERVICE
STUDY OF SYPHILIS COMMONLY
REFERRED TO AS THE TUSEXPERIMENT
AND IT WAS EARLY IN MY CAREER
THIS IDEA OF HOLDING THE
GOVERNMENT ACCOUNTABLE FOR WHAT
IT HOLDS THE PEOPLE FOR WHAT IT
IT SERVES AND THIS IS WHAT I'VE
CARRIED AT THE NIH.
I STARTED WORKING HERE AROUND
991999 AND ALTHOUGH MY
APPOINTMENTS HAVE SHIFTED AROUND
A BIT OVER THE YEARS, I'VE HAD A
JOINT ARRANGEMENT IN PARALLEL
WITH IRB RELATED SERVICE AND
TRAINING AS WELL AS BIOETHICS
RESEARCH THAT MOSTLY HAS FOCUSED
ON ETHICAL ISSUES IN GENETICS
RESEARCH AT LEAST IN THE
BEGINNING.
AND THE TRAINING AND CAPACITY
BUILDING WORK IN RESEARCH ETHICS
BEGAN MORE WITH THE FOCUS ON
SUPPORTING LOW AND MIDDLE INCOME
COUNTRY AND IT SHIFTED TO
INCLUDE COMMUNITIES IN THE
UNITED STATES AND AS I LEARNED
ABOUT TRIBAL SOVEREIGNTY AND
TRIBAL IRBs AND THE PERSIST
APARTMENT HISTORY OF UNETHICAL
RESEARCH WITH NATIVE COMMUNITIES
AND MY WORK GRADUALLY SHIFTED TO
FOCUS ON THAT CONTEXT.
AND TO THIS AMAZING TEAM THAT
I'VE BEEN ABLE TO JOIN THE
TRIBAL HEALTH RESEARCH OFFICE
OVER THE PAST YEAR-AND-A-HALF ON
DETAIL TO MAKE INNS INTENSE GOOD
PROGRESS ON INITIATIVES THAT
WE'VE BEEN WORKING COLLABORATIVE
TOGETHER ON FOR SOME TIME.
SO THAT BRINGS ME TO 2016, NEXT
SLIDE, PLEASE.
AND THE FIRST TIME I WAS INVITED
TO PRESENT TO THE TRIBAL
ADVISORY COMMITTEE, TO GET YOUR
INPUT ON SOME NEW AND EMERGING
TRAINING OPPORTUNITIES THAT I
AND OTHERS WERE COLLABORATING ON
AND YOU CAN SEE MY WONDERFUL
COLLEAGUE, WHO WAS AT IHS AT THE
TIME WAS ALSO AT THE TABLE.
AND NEXT SLIDE, WE TOOK THE TEXT
FEEDBACK AND ENCOURAGEMENT SER
OBVIOUSLY AND MOVED NUMBER WITH
COLLABORATIVE INITIATIVES AND WE
HELD THIS VERY SUCCESSFUL FULL
DAY BIG CONFERENCE WORKSHOP AT
THE NATIVE WORKSHOP MEETING IN
CHEROKEE NORTH CAROLINA AND IT
WAS IN-DEPTH INTO THE ROLES AND
FUNCTIONS OF DIFFERENT MODEL OF
TRIBAL IRBs AND RESEARCH
OVERSIGHT MECHANISMS AND TOOL
KITS, VARIOUS ETHICAL
FRAMEWORKS, PEACE STUDIES AND IT
WAS ORGANIZED BY A TEAM OF
PEOPLE FROM THE NIH AND THE
PERKA PROGRAM, NCAI.
THE MAJORITY WERE AMERICAN
INDIAN AND ALASKA NATIVE
RESEARCHERS AND IT DEMONSTRATED
THAT THERE REALLY WAS A STRONG
INTEREST IN AND NEED FOR THIS
KIND OF CONTENT AND THAT
LAUNCHED A NEXT SLIDE.
THAT WAS AN ONGOING AND OF A
PROFESSIONAL ORGANIZATION THAT
STANDS FOR PROFESSIONAL
RESPONSIBILITY IN MEDICINE AND
RESEARCH AND I WOULD
CHARACTERIZE THEM AS ONE OF THE
LEADING PROFESSIONAL
ORGANIZATIONS FOR ALL ASPECTS OF
IRB RELATED WORK.
SO THIS COLLABORATION HAS
ALLOWED US TO DEVELOP CONTENT
THAT THEY HAVE BEEN WILLING TO
MAKE FREELY AVAILABLE TO THE
RESEARCH COMMUNITIES TO ADDRESS
TIMELY AND EMERGING POLICY
ISSUES OF RELEVANCE TO THE
TRIBAL COMMUNITIES SUCH AS, THE
EMERGING SINGLE IRB POLICY RIGHT
AROUND THE TIME, I THINK IT WAS
IN ADVANCE OF THE 2018 COMMON
RULE REVISIONS THAT Dr. BERGER
WAS REFERRING TO.
AND WHERE WE HAVE AN UPCOMING
WEBINAR THAT WE'RE NOT IN THE
WEEKENDS OF PLANNING ON THE NIH
DATA SHARING POLICY AND TABLE
AND WE HEARD FROM Dr. BERGER
WILL SAY MORE IN A MOMENT ABOUT
THAT.
NEXT SLIDE.
IT WAS ALSO, I THINK, VERY
EXCITING AT THE 2017, I THINK IT
WAS, ANNUAL MEETING TO HAVE A
PLENARY SESSION ON THE ROLE OF
TRIBAL SOVEREIGNTY AND RESEARCH
AND SO THIS PHOTOGRAPH OF PAP
EAPANELISTS AND PARTICIPANTS ISA
SNAPSHOT OF THE REPRESENTATIVES
OF THE DIFFERENT MODEL OF TRIBAL
IRBs, TRIBAL COLLEGES, TRIBAL
GOVERNMENTS AND THIS WAS
ADDRESSING A VERY DIFFERENT AND
MUCH BROADER NATIVE AUDIENCE
COMPARED TO THE NRN WORKSHOP
THAT I MENTIONED.
IN ADDITION TO BRINGING THIS
MESSAGE, THESE MESSAGES TO A
BROADER RANGE OF AUDIENCES,
WE'VE ALSO BEEN WORKING ON
REFINING THE MESSAGE ITSELF AND
THESE ARE SCREEN SHOTS.
AND SOME OVER SIMPLIFICATIONS
WE'VE SEEN IN THE USE OF
FAMILIAR CASES, FOR EXAMPLE, I
TAKE SERIOUSLY FEEDBACK I'VE
RECEIVED FROM TRIBAL LEADERS,
THAT WHEN WE'RE TALKING ABOUT
ETHICS CASES WE REALLY NEED TO
BE CAREFUL ABOUT HOW WE REFER TO
THEM AND HOW WE NAME THEM.
SO THAT WE SEE DON'T PERPETUATE
THE SIGNA ATTACHED TO THEM SO
YOU MIGHT HAVE NOTICED THAT I
MADE A POINT OF REFERRING O THE
U.S. PUBLIC-HEALTH SERVICE STUDY
EARLIER AND I ALSO MAKE A POINT
OF REFERRING TO THE ARIZONA
STATE UNIVERSITY CASE.
AND THAT HELPS TO REFRAME THE
THE MISUNDERSTANDING OF ROLE OF
CONSENT AND ADEQUACY OF BROAD
CONSENT FOR RESEARCH ON SAMPLES
COLLECTED FROM THE TRIBAL
MEMBERS THAT THEY HAD
SPECIFICALLY REQUESTED TO USE
FOR TYPE-2 DIABETES AND WENT ON
TO BE USED FOR MANY OTHER
RESEARCH TOPICS AND THAT WERE
HARMFUL TO THEIR INTERESTS.
BUT THESE CASES ALSO RAISE VERY
IMPORTANT QUESTIONS AND BROADER
QUESTIONS OF EQUITY AND JUSTICE
CONSIDERATIONS AND HOW DO WE
THINK ABOUT THOSE.
WE WERE ALSO MINDFUL OF FLIPPING
THE SCRIPT FOR SUCCESSFUL
COLLABORATION AND TRUST BUILDING
LOOKS LIKE WHICH THEY DID A
BRILLIANT JOB OF.
NEXT SLIDE.
I JUST WANT TO QUICKLY MAKE SURE
YOU ARE AWARE OF SOME ADDITIONAL
SOURCES OF NIH SUPPORT FOR
TRIBAL IRWs AND I BELIEVE THE
TAC HAS HEARD ABOUT THE
EVALUATION OF THE NARCH PROGRAM
UNDERTAKEN.
I KNOW DR. TABAK MENTIONED IT IN
HIS COMMENTS EARLIER TODAY.
ONE OF THE IMPORTANT MESSAGES
RECEIVED WAS ABOUT PROVIDING
TANGIBLE SUPPORT FOR --
FINANCIAL SUPPORT TO TRIBAL
IRBs FOR INFRASTRUCTURE AND
JUST LAST MONTH, I WAS ABLE TO
SIT INTO WATCH TO OBSERVE A
PUBLIC MEETING OF THE NIGMS
COUNCIL THAT WAS REQUESTING
CONCEPT CLEARANCE FOR SOME
FOURTH COMING FUNDING
OPPORTUNITIES THAT WE CAN BE ON
THE LOOK OUT FOR.
AND THERE ARE ALSO OTHER BOLDER
MATERIALS CHECKLISTS AND COOL
KITS SUCH AS THE ONE HERE THAT
FOLKS MIGHT HAVE FOUND HELPFUL.
AND I DO THINK IT'S IMPORTANT TO
VIEW ETHICS TRAINING AND
CAPACITY BUILDING BOTH OUTWARD
PHASING ACTIVITIES BUT ALSO, IN
WARD FACING CAPACITY BUILDING
ACTIVITIES AND WE NEED TO TURN
THE MIRROR IT'S THE MICROSCOPE
AS SOME OF MY SCIENCE COLLEAGUES
LIKE TO SAY ON OURSELVES.
THIS HAVE BEEN A LOT OF EFFORTS
WITHIN OUR INTRAMURAL RESEARCH
PROGRAM AND THIS IS THE RESEARCH
THAT TAKES PLACE ON CAMPUS IN
OUR RESEARCH AND HOSPITAL WITH
OUR OWN RESEARCH BASED ON STAFF
TO AUGMENT THE STANDARD CITY AND
OTHER ON-LINE RESEARCH ETHICS
TRAINING MODULES THAT EACH AND
EVERY INVESTIGATOR, WHO
CONDUCTED HUMAN SUBJECTS REHAS
TO COMPLETE.
SO FOR EXAMPLE, THIS THE THIRD
YEAR THAT WE'VE BEEN VERY
FORTUNATE TO HAVE Dr. KATRINA
CLAW, A NATIVE BIO ETH SIS
COLLEAGUE PARTICIPATE IN THE
GUEST LECTURE ON THE TOPIC OF
INCLUSION OF NATIVE POPULATIONS
IN RESEARCH AND OF COURSE THAT'S
OFFERED ANNUALLY BY OUR CLINICAL
CENTERS DEPARTMENT OF BIOETHICS
AND Dr. WILSON AND I WERE I AM
INVITED LASTINVITED BY THE NIH ,
OHSRP, NOT TO BE CONFUSED WITH
OHRP TO GIVE A PRESENTATION TO
THE ENTIRE NIH COMMUNITY THAT
WAS FRAMED FOR OUR INTRAMURAL
COLLEAGUES BUT WE HAD MANY WHO
WERE EXTRAMURAL STAFF AS WELL
AND THIS WAS REALLY TO MAKE SURE
OUR COLLEAGUES UNDERSTAND WHAT
TRIBAL SOVEREIGNTY AND THE
HISTORICAL CONTEXT AND WHAT OUR
PARTICULAR OBLIGATIONS IS A
FEDERAL AGENCY ARE AND HOW THAT
RELATES TO THE ETHICAL OVERSIGHT
OF THE TRIBAL RESEARCH THAT WE
CONDUCT IN THE INTRAMURAL
RESEARCH PROGRAM.
I ALSO I ALLUDED TO THIS
EARLIER, WE'VE RECENTLY ADDED A
CHECKLIST TO OUR INTRAMURAL IRB
APPLICATION FORM TO MAKE SURE
THAT OUR INTRAMURAL IRB OF WHICH
I SERVE AS ONE OF THE CHAIRS, TA
WE KNOW THAT OUR WHOLE GROUP,
OUR WHOLE TEAM KNOWS WHEN ONE OF
OUR OWN RESEARCHERS IS PROPOSING
TO DO TRIBAL RESEARCH SO WE CAN
PAUSE TO ENSURE THE APPROPRIATE
LEVEL OF TRIBAL REVIEW, HAS
TAKEN PLACE.
AND YOU KNOW, I DO WANT TO MAKE
CLEAR THIS IS LIMITED.
THIS PERTAINS TO THE INTRAMURAL
RESEARCH PROGRAM BUT I'M ALWAYS
THINKING ABOUT HOW WE COMPARE
NOTES WITH OUR EXTRAMURAL
COLLEAGUES AND THIS IS WHERE OUR
PARTNERSHIP WITH OTHERS WILL
ALLOW US TO SHARE BEST PRACTICES
AND RESOURCES THAT ARE WORKING
WITHIN THE BROADER RESEARCH NOT
COMMUNITY.
LET ME NOW HAND THE MIC BACK TO
Dr. BERGER FOR THE NEXT
SECTION.
>>THANK YOU, Dr. HULL.
I WANT TO TO, HARK INBACK FROM E
HISTORICAL REVIEW WHICH IS THAT
CONCEPT OF INFORMED CONSENT SO
THAT'S WHERE WE'RE GOING TO HEAD
THE DIRECTION NOW.
IT'S GETTING HOW CONSENT IS
DEVELOPED AND WHAT ARE THE
REQUIREMENTS AND YOU KNOW,
AGAIN, JUST A REMINDER, WE DON'T
OVERSEE THE COMMON RULE HERE AT
NIH AND THAT'S OVER SEEN BY HHS,
SO I'M JUST LISTENING WHERE
THOSE REQUIREMENT RIGHT SIDE AND
THE COMMODITIES ITSELF IS UNDER
116 WITH SIX GENERAL
REQUIREMENTS AND NINE ELEMENTS
OF THE INFORMED CONSENT AND I'M
NOT GOING TO GO OVER THEM
SPECIFICALLY BUT WE'LL JUST NOTE
THE PURPOSE IS REALLY TO ENSURE
THAT A PRO RESPECT OF RESEARCH
PARTICIPANTS HAS THE INFORMATION
THAT A REASONABLE PERSON WOULD
WANT TO HAVE TO MAKE A DECISION
ON WHETHER THEY WANT TO
PARTICIPATE IN A STUDY OR NOT.
IN ADDITION TO INFORMED CONSENT
THERE'S ALSO AN ALTERNATIVE
CONSENT PROCESS WHICH IS A FRAUD
CONTENT AND NOW THE THING TO BE
AWARE OF HERE, THIS IS ALL LAID
OUT IN THE COMMON RULE AGAIN,
IT'S THE BROAD CONSENT ATTAINING
MOVING FORWARD CONSENT BUT ONLY
FOR STORES AND SECONDARY
RESEARCH USES OF IDENTIFIABLE
DATA AND BIOSPECIMENS.
SO, THIS IS WHERE THE BROAD
FRAMING AROUND CONSENT COMES
FROM AND AND IT'S WHY I'M
WINNING THE AND CONTEMPLATED AS
PART OF THE GDS POLICY AND THE
GDS POLICY IS RESEARCH
GENERATING LARGE-SCALE HUMAN OR
NON HUMAN GENOMIC DATA USING
THESE DATA AND THE IDEAS IT
ENSURES BROAD RESPONSIBLE AND
TIMELY SHARING GENOMIC DATA AND
IT WAS DEVELOPED THROUGH
EXTENSIVE STAKEHOLDER
INCOMPETEINCOMSTAKE HOLDINTERAC.
THIS IS AN EXPECTATION THAT IRB
REVIEW AND IT DETERMINES WHETHER
IT'S APPROPRIATE FOR DATA IS
SHARED OR SECONDARY RESEARCH IS
GOING TO BE ACCOMPLISHED AND AND
I ALSO EXPECT AND GENOMIC AND
FUTURE RESEARCH PURPOSES AND
THAT IS TRUE EVEN IF CELL LINES
DEIDENTIFIED AND THIS IS THE
COMMON AND CELL LINE IS SUBJECT
TO RESEARCH AND WE ARE UNDER THE
POLICY REQUIRE HAVE THAT
EXPECTATION.
WE HAVE A COUPLE OF ADDITIONAL
RESOURCES AND AWARENESS FOR
CONSENT AND TOGETHER AND POLICY
AND THE SECOND ONE AND IS A NEW
RESEARCH AND AND I JUST WANT TO
STRESS AND IT'S VOLUNTARY USE
WITH NO REQUIREMENTS FOR
EXPECTATIONS AND FOR NIH AND THE
SAMPLE LANGUAGE CONTAINED WILL
BE USED FOR CONSENT FORM ANY
STUDY THAT WE'RE SUPPORT
ORGANIZE CONDUCTING ITSELF.
IT WAS DEVELOPED TO BE IN
RESPONSE AT THE STAKEHOLDER
INTEREST AND EXPRESS NEEDS FOR
SAMPLE LANGUAGE SO WE WERE
TRYING TO BE HELPFUL FOR THE
COMMUNITY HERE.
AND I WANT TO NOTE WE CALL OUT
THE ENCOURAGEMENT FOR THOSE
DEVELOPING AND REVIEWING TO SEE
CONSULTATION ON TRIBAL
REQUIREMENTS AND CULTURAL PREF
REFERENCES PRIOR TO STORAGE AND
SHARING OF DATA AND
BIOSPECIMENS.
WITH THAT I'M GOING TO SEND IT
BACK TO Dr. HULL TO
CONTEXTUALIZE THESE CONSENT
PIECES AND HOW THEY APPLY HERE
FOR A MORE TRIBAL CONCEPT.
>>THANK YOU.
SO PRETTY EARLY ON IN MY CAREER,
MY MENTORS AND THE CLINICAL
CENTERS DEPARTMENT OF BIOETHICS,
TAUGHT ME THAT ALTHOUGH CONSENT
IS IMPORTANT, IT'S NEVER THE
FILLS ITEM ON THE LIST OF WHAT
WE NEED TO DO TO ENSURE THAT
RESEARCH IS ETHICAL.
EVEN THOUGH WE SEE FUTURE AND -U
SEE IN THIS LIST OF BENCHMARKS,
NEXT SLIDE, CONSENT IS THE
SEVENTH ITEM ON HAD LIST OF
BENCHMARKS AFTER WE HAVE A LOT
OF OTHER STUFF THAT STARTS
WITHEN GAMING THE COMMUNITY AND
A COLLABORATIVE PARTNERSHIP.
AND IT IT -- BETWEEN GROUP
BUY-IN AND INPUT IN ENDORSEMENT
OF A PROJECT LEADERSHIP ENFORCE
DOERSMENT OF A PROJECT AND
INDIVIDUAL CONSENT.
AND THE INDIVIDUAL CONSENT IS A
PROCESS THAT CAN AND SHOULD BE
DEVELOPED INPUT FROM THE
COMMUNITY AND THE LAST SLIDE
Dr. BERGER HAD SHARED.
I ALSO WOULD POINT OUT ALTHOUGH
MY MENTORS WERE TALKING ABOUT
THE INTERNATIONAL RESEARCH
CONTEXT HERE, I WOULD ARGUE THAT
THIS IS ACTUALLY MUCH MORE
ANALOGOUS AND RELEVANT TO THE
TRIBAL RESEARCH AND IT'S REALLY
INTERESTING TO SEE HOW THIS MAPS
ON TO OTHER PRESENTATIONS OF
COMMUNITY-BASED PARTICIPATORY
AND TRIBALLY ENGAGE RESEARCH.
NEXT SLIDE.
I CAN ALSO SAY THAT THROW AND
ESPECIALLY IN THE CONTEXT OF MY
DETAIL, AS A LIAISON BETWEEN
FLOW AND THE IRB WE'VE BEEN
WORKING CLOSELY WITH THE
INTRAMURAL IRB ON A FAIRLY
REGULAR BASIS AND THIS HAS
INCLUDED WORKING TOGETHER TO
TAILOR CONSENT FOR FOREIGN
LANGUAGE ON A CASE-BY-CASE BASS
FOR DIFFERENT TRIBAL RESEARCH
PROTOCOLS.
AND FOR EXAMPLE, SO HERE, THIS
IS SOME SAMPLE LANGUAGE THAT
TEASES OUT, YOU CAN SEE IN RED,
THIS IS LANGUAGE THAT IS NOVEL
THAT DEVIATES FROM OUR LANGUAGE
AND IT DISCUSSES PARTICIPANTS,
TRIBAL PARTICIPANTS IN RESEARCH
AND INTEREST IN KNOWING HOW
THEY'RE PARTICIPATION MAY HARM
OR BENEFIT GROUPS TO WHICH THEY
BELONG IN THE NEXT SLIDE THERE'S
AN ANIMATION.
THIS IS BORN OUT BY AWE NUMBER
OF ATTITUDE NAL SURVEYS AND ALSO
JUST DISCUSSIONS WITH
INDIVIDUALS GROUPS AS WELL AS
INPUT FROM GENETIC COUNCILORS
AND OTHERS.
SO THIS IS JUST A GLIMPSE OF HOW
WE'VE BEEN TALKING ABOUT
TAILORING SOME OF OUR CONSENT
FORM PROCESSES ALONG THESE
LINES.
BACK TO YOU, Dr. BERGER.
>>SO, YOU KNOW, WE'VE GONE FROM
CONSENT TO MAKE SURE THAT PEOPLE
ARE VOLUNTARILY WILLING TO
PARTICIPATE IN STUDIES TO NOW
MOVING TOWARDS WHAT HAPPENS WITH
THE DATA THAT IS GOING TO BE
GENERATE INTERESTED
PARTICIPATION IN THAT STUDY
ITSELF AND YOU KNOW, AS YOU
HEARD THIS MORNING, SO I'M NOT
GOING TO SPEND A LOT OF TIMES ON
THESE MUCH BECAUSE DR. TABAK
DESCRIBED THESE SO WELL, NIH HAS
RELEASED A DATA MANAGEMENT
SHARING POLICY AND I REALLY
WANTED TO BIG A PUT AND THEY ARE
IN THE DRIVERS AND WILLING TO
SHARE SLIDES AND WITH MEZZANINE
AND WELCOME BACK THIS TALK SO
WHY DOES NIH WANT DATA TO BE
SHARED.
BASICALLY, IT'S TO REPRODUCE
MORE RESEARCH AND PROMOTING
TRUST AND RESEARCH ITSELF.
SO THE POLICY REQUIRES
SUBMISSION OF A PLAN FOR ALL
NIH-FUNDED RESEARCH AND WHEN
IT'S APPROVED, THE EXPECTATION
IS THE RESEARCH ACTUALLY
COMPLIES WITH IT AND THAT'S THE
BEST WAY I CAN BOIL IT DOWN.
NOW, THIS SCOPE HERE IS IT
APPLIES TO ALL NIH SUPPORTER
RESEARCH GENERATING SCIENTIFIC
DATA AND WE HAVE THINGS THAT ARE
RELATED TO FACTUAL MATERIAL AND
VALIDATING AND REPLICATING
RESEARCH FINDINGS.
THE EXPECTATION HERE IS THE DATA
SHARING SHOULD BE MAXIMIZED,
RESPONSIBLY IMPLEMENTED AND
PERSPECTIVELY PLANNED FOR AT ALL
STAGES OF THE RESEARCH PROCESS.
SO NOW, THE PURPOSE IS TO
MAXIMIZE APPROPRIATE SHARING BUT
AS DR. TABAK STRESSED, AND SORRY
I WAS FLIPPING THIS BASED ON HOW
HE DESCRIBED THINGS THIS
MORNING.
NIH HAS A HUGE RESPECT FOR
TRIBAL SOVEREIGNTY AND IT'S
RESPONSIBLE MANAGEMENT EX
SHARING OF AMERICAN INDIAN AND
ALASKA NATIVE DATA AND
EXPLICITLY, NOTED HERE IS THAT
TRIBAL LAWS REGULATIONS ARE
POLICIES THAT PROHIBIT
DISCLOSURE AND CONSTITUTE ADJUST
FIE FIE ABLE LIMIT.
WE MADE SURE IT WAS BUILT INTO
THE ACTUAL POLICY ITSELF.
DR. TABAK DESCRIBED THE
SUPPLEMENTS SO I WON'T GO INTO
IT IT VERY MUCH.
JUST QUICKLY NOTE IT'S REALLY
MEANT TO ASSIST INVESTIGATORS
AND IN DEVELOPING PLANS AND
EMPHASIZES THE RESPECT FOR
TRIBAL SOVEREIGNTY AND
PARTNERSHIPS IN MUTUAL
AGREEMENTS AND BUILDING TRUST.
AND YOU KNOW, DR. TABAK ALSO
WENT THROUGH THIS SO I WON'T GO
THROUGH THIS AGAIN, BUT AGAIN
IT'S THIS CONCEPT OF BEST
PRACTICES FOR HOW WE ENGAGE AND
IN RESPONSIBLE MANAGEMENT AND
SHARING AND NOT IT'S
UNDERSTANDING ITS ENGAGEMENT AND
ESTABLISHMENT AND YOU ARE SEEING
A LITTLETATIONS THAT WE HAVE
A LITTLETATIONS FOR THE ABILITY
OF THE LIGHTS TO STAY ON SO I'M
GOING TO STAND IN DARKNESS FOR
THE REST OF THIS TALK APPARENTLY
BUT YOU KNOW, AGREEMENTS AND WHO
WILL MANAGE THE DATA AND
CONSIDERATION OF ADDITIONAL
PROTECTIONS AS WELL.
BACK TO Dr. HULL AND I'M GOING
TO SEE IF I CAN GET THE LIGHTS
TURNED ON.
>>AN NIH INSTITUTE DIRECTOR IS
TALKING ABOUT INDIGENOUS DATA
SOVEREIGNTY AND THE CARE
PRINCIPLES.
THIS IS A SNIPPET FROM A
NEWSLETTER THAT Dr. GREEN, WHO
IS THE DIRECTOR OF THE GENOME
INSTITUTE THAT EMPLOYS ME SENT
OUT PERIODICALLY I FORGET IN ITS
MONTHLY OR QUARTERLY BUT IT'S
ADDRESSED TO THE BROADER GEEZ
NOAM I CAN RESEARCH COMMUNITIES
AND SO FROM WHERE I SIT, THIS IS
AN IMPORTANT AND ALSO FAIRLY
RESENT CULTURAL WITHIN THE
INSTITUTE AND WITH THE NIH OVER
ALL, Dr. BERGEN IS BACK.
AND JUST GOING BACK ONLY A FEW
YEARS AGO, THIS WAS IN 2017,
THERE WERE A HANDFUL OF US AT
NIH WHO WE WERE VERY FORTUNATE
TO BE INVITED TO PARTICIPATE IN
LARGELY INACTIVE LISTENING MODE
TO A DATA SHARING WORKSHOP THAT
WAS RUN BY THE NAVAJO NATION AND
IT WAS HELD IN NEW MEXICO TO
TAKE A LOOK AT BETTER INTERNET
AND FACILITIES AND THE AGENDA
INCLUDED, IT WAS REALLY FUN, WAS
PRE CONFERENCE WORKSHOP FOR THE
COMMUNITY ON THE SCIENCE OF
GENETICS AND THINGS LIKE
EXTRACTING DNA FROM A STRAWBERRY
THAT GENERATED A LOT OF
ENGAGEMENT.
BUT THE MAIN WORKSHOP FOCUSED ON
THE HISTORY AND CONTEXT OF THE
AND A HALF A HAD HE NATIONS
MORATORIUM AND ON GENETIC
RESEARCH AND IT WAS A REALLY
IMPORTANT LEARNING CURVE FOR ME
AND MY COLLEAGUES TO ENGAGE IN
AND CULTURAL PERSPECTIVES ON THE
IMPORTANCE OF RESEARCH AND
RESEARCH THAT TAKES PLACE WITHIN
THE COMMUNITY, INDIGENOUS
KNOWLEDGE METHODS, DIFFERENT
METHODOLOGIES AND STARTING TO
ENGAGE WITH ALTERNATIVES AND
SOLUTIONS THAT MIGHT LEAD TO
REPLACING THE MORATORIUM WITHIN
AN EFFECTIVE POLICY THAT WOULD
ALLOW GENETIC RESEARCH TO
PROCEED WHILE ENSURE ADEQUATE
PROTECTIONS OF THE RIGHTS AND
INTERESTS OF CITIZENS OF THE
NAVAJO NATION.
IT WAS REALLY REMARKABLE FOR ME
TO MEET AND HEAR THE PRESIDENT
OF AND NAVAJO NATIONS.
THE FORMER PRESIDENT, THE
HONORABLE PRESIDENT RUSSELL
BAGAY, TALKING ABOUT BIOMEDICAL
ETHICS AND EVEN TO MEET HIM
IN-PERSON, IF YOU FLIP TO THE
NEXT SLIDE, YOU WILL SEE THAT I
FINALLY MADE IT INTO THE
PHOTOGRAPH WITH THE LEADER --
WHOOPS.
WITH THE LEADER OF A GREAT
NATION.
IT'S OK.
IT GENERATED A FAIR AMOUNT, A
LITTLE BIT OF NEWS COVERAGE AS
WELL WHICH WAS INTERESTING.
SO THE NEXT ONE IS THE ONE WITH
THE GREAT PHOTO THAT I LOVE AND
YOU WILL SEE I LOVE IT SO MUCH
THAT IN THE NEXT SLIDE, WHEN I
CAME BACK, INVITE TODAY PRESENT
AND YOU CAN SEE THIS ALSO
INCLUDED IN THE PHOTO SOME
MEMBERS OF THE NAVAJO NATION IRB
THE THEN IRB CHAIR WAS AT THE
TABLE AND I CAME BACK AND WE
WERE TALKING ABOUT THE TOPIC OF
SOME OF THE OLDER NIH DATA
SHARING POLICIES AND I WAS ABLE
TO SHARE MY IMPRESSIONS AND
LESSON LEARNED FROM THE WORKSHOP
IN ALBUQUERQUE.
NEXT SLIDE.
THE REALLY MOST IMPORTANT
MESSAGE I THINK THAT I BROUGHT
BACK TO THE NIH AND REPEATED TO
ANYBODY WHO WOULD LISTEN, WAS
SHARED AND EMBEDDED IN A
DOCUMENT RELATED TO THE NATIONAL
TRIBAL BEHAVIORAL HEALTH AGENDA
BUT IT WAS SHARED BY A GROUP OF
TRIBAL LEADERS AND IN A SET OF
RECOMMENDATIONS TO FEDERAL
AGENCIES AND OTHERS WHO WERE IN
A POSITION TO FUND OR SUPPORT
THE BEHAVIORAL HEALTH AGENDA FOR
TRIBES AND THE ADVICE WAS MODIFY
YOUR REQUIREMENTS TO FIT THE
RELEVANT TRADITIONAL TRIBAL
PARADIGM OR ALLOW ROOM FOR
FLEXIBILITY WHEN EVALUATING
PROPOSALS SUBMITTED BY AMERICAN
INDIAN AND ALASKA NATIVE TRIBAL
NATIONS.
AND SO WHEN I TALK ABOUT A
CULTURAL SHIFT, I AM NOW SEEING
EVIDENCES OF THIS FLEXIBILITY
NOT AS A RARE EXCEPTION, BUT
REALLY AS A CHARACTERISTICS OF
THE EMERGING DATA SHARING
POLICIES THAT WE'VE BEEN TALKING
ABOUT.
FLEXIBILITY, THAT IS APPROPRIATE
TO UTILIZE, TO ALLOW
COLLABORATION AND ALLOW PRO PRO
AT RESEARCH.
I WANT TO MENTION ANOTHER
RESEARCH THE NEXT YEAR, THE NEXT
SLIDE, WHERE WE PARTICIPATED
MORE ACTIVELY IN A WORKSHOP THAT
WAS GRACIOUSLY HOSTED BY THE
SOUTH CENTRAL FOUNDATION AND
ANCHORAGE, ALASKA.
AND I WAS INVITED TO BE PART OF
A NO PANEL FOCUSING ON KEY
QUESTIONS RELATED TO DATA
SHARING.
THE RESULTS OF THIS WORKSHOP AND
YOU CAN SEE HOW VERY WELL
ATTENDED IT WAS, IT WAS REALLY
INTENSIVE OVER SEVERAL DAYS AND
IT RESULTED IN THIS
PUBLIC-PATIENT THAT I'M HAPPY TO
SHARE.
WE REALLY DRILLED DOWN INTO SOME
VERY IMPORTANT QUESTIONS ABOUT
WHAT GUIDELINES SHOULD GOVERN
DATA SHARING FOR ALASKA NATIVE
PEOPLE, WHAT ARE SOME OF
CONCERNS OR I AM TENSIONS OR INE
DATA SHARING MODEL AND HOW
SHOULD WE PR PREPPED MOTTLE ANDE
NEXT SLIDE, REALLY IMPORTANT
MESSAGES THAT WE HEARD.
ALASKA NATIVE LEADERS WERE NOT
OPPOSED TO DATA SHARING AS AS I
CONCEPT AND THEY WERE JUST
CONCERNED ABOUT THE SPECIFICS
AND THE PRINCIPLES THAT
FLEXIBILITY AND I WAS TALKING
ABOUT A MOMENT AGO AND JUST
INCREASED COMMUNICATION ABOUT
THE DETAILS.
THE NEXT SLIDE.
THAT'S YOU.
>>THANK YOU Dr. HULL.
JUST TO KIND OF NAVIGATE WHERE
WE'VE GONE TODAY.
WE'VE TALKED ABOUT THE LEAD UP
TO ACTUALLY ESTABLISHING THE
PROTECTIONS THAT WE HAVE IN
PLACE AND TO THINKING ABOUT WHAT
HAD OF THOSE PRETEXTS ARE IN
TERMS OF CONSENT AND OTHER
REQUIREMENTS AND SO THAT GETS
YOU INTO ACTUALLY HAVING
RESEARCH PARTICIPANTS TAKING
PART AND STUDIES.
>>AND THE FIRST IS THE
INCLUSION OF WOMEN AND
MINORITIES AND WOMEN AND
MINORITY GROUPS MUST BE IN ALL
NIH CLINICAL FUNDED STUDIES AND
ANY EX CLUE EXCLUSIONS HAVE BEED
ON A RATIONALE AND THE SECOND
POLICY WORTH DISCUSSING HERE IS
WHEN IT'S EFFECTIVE DAY HAS BEEN
BUT THE PURPOSES THAT TO MAKE
SURE INDIVIDUALS OF ALL AGES ARE
INCLUDED IN NIH HUMAN SUBJECTS
RESEARCH AND IN THIS CASE
SIMILAR TO WHAT I MENTIONED FOR
THE MINORITIES AND INCLUSION
POLICY AND EXCLUSIONS HERE HAVE
BEEN BASED ON SCIENTIFIC OR
ETHICAL REASONS AND SO THAT'S
THE -- THESE FORM THE CRUX OF
OUR INCLUSION POLICIES AND
OBVIOUSLY WE HAVE A LOT MORE
ACTIVITIES THAT ARE GOING ON AND
WHETHER THEY'RE UNITE
INITIATIVES OR OTHER TYPES OF
EFFORTS AROUND HEALTH EQUITY AND
INVOLVED ENGAGEMENTS AND ACTIONS
AND I'M GOING TO TURN IT OVER TO
Dr. HULL AT THIS POINT TO WALK
US THROUGH THE REST OF THIS AND
HOW APPLIES MORE IN THE TRIBAL
CONTEXT.
>>WELL, WHEN WE COLLECT DATA
ABOUT WHO WAS INCLUDED IN
RESEARCH, WE LEARNED A LOT ABOUT
WHO IS NOT INCLUDED AND YOU
MAKING FAMILIAR WITH THIS VERY
IMPORTANT PIE CHART PUBLISHED IN
FULLERTON THAT ILLUSTRATES JUST
HOW LIMITED REPRESENTATION OF
ANCESTRY GROUPS OTHER THAN
EUROPEAN ANCESTRY GROUPS ARE IN
OUR REPOSITORIES WITH ONLY
SUBTLE IMPROVEMENTS OVER TIME.
BUT, THAN THIS HAS ANIMATED SOME
VERY IMPORTANT DISCUSSIONS ABOUT
DIVERSITY AND DIVERSIFICATION OF
OUR RESEARCH RESOURCES.
WE NEED TO MAKE SURE IT ISN'T
JUST RECRUIT HARDER, THAT'S
WHERE WE RUN INTO TROUBLE.
I LIKE HOW Dr. CLAW TALKED
ABOUT THIS IN HER PRESENTATION
TO THE NIH RESEARCH ETHICS
COURSE LAST MONTH.
NEXT SLIDE.
SHE CA I'M USING THIS SCREEN SHT
WITH HER PERMISSION.
THERE'S A RISK OF PERPETUATING A
CYCLE OF VICTIM-BLAMING AND
COERCION WHEN WE TELL TRIBAL
COMMUNITIES THAT THEY'LL MISS
OUT OPT ON THE BENEFITS TO
ENROLL IN STUDIES, INSTEAD OF
DISRUPTING THE CYCLE BY
ADDRESSING THE ROOT CAUSES AND
LOOKING AT A BROADER VIEW OF THE
SYSTEMS WITHIN WHICH THESE
STUDIES ARE BEING CONDUCTED.
NEXT SLIDE.
SO, THE AMERICANS SOCIETY OF
HUMAN GENETICS RELEASED THE
RESURESULTS OF A GENOMIC WORKFOE
SURVEY AND THERE WERE
PROFESSIONALS SOCIETIES WHO WERE
SURVEYED, LIKE GWAS DID, NOT
EXACTLY BECAUSE HEAR THEY'RE
FRAMED IN RACE AND ETHNICITY BUT
WE SEE A LACK OF DIVERSE
REPRESENTATION AND IT MIGHT
PROVIDE US A CLUE ABOUT WHY THE
REASONS FOR UNDERSTAND INCLUSION
OF DIVERSE RESEARCH PARTICIPANTS
AND THIS CONNECTS WITH THE
IMPOTENCE FOR SOME RECENT AND
EMERGING DEVELOPMENTS AND WE
HAVE APP ACTION PLAN, NEXT
SLIDE.
THAT ASSERTS THE PROMISE OF
GENOMICS, CAN'T BE FULLY
ACHIEVED WITHOUT ATTRACTING,
DEVELOPING AND RETAINING A
DIVERSE WORKFORCE THAT INCLUDES
PEOPLE FROM GROUPS UNDER
REPRESENTED IN THE GENOMIC
ENTERPRISE AND I'VE BEEN GETTING
MORE INVOLVED WITH EFFORTS, FOR
EXAMPLE, TO DEVELOP A RACIAL AND
ETHNIC EQUITY PLAN FOR OUR
INTRAMURAL WORKFORCE AND THE
GENOME INSTITUTE AND I'M LOOKING
FORWARD TO CONTRIBUTING TO THESE
EFFORTS WHEN MY DETAIL WRAPS UP
TO ALSO IT'S BEEN GREAT TO WORK
WITH TRAINEES DURING MY THROW.
SOME OF YOU GOT TO MEET OUR
SUMMER INTERN FROM LAST YEAR WHO
IS NOW OFF JUST DOING ABSOLUTELY
GREAT RESEARCH AND Dr. CLAUSE
LAB AND HEADING TOWARDS A VERY
FRUITFUL CAREER IN BIO ETHICS.
THIS IS THE LAST SLIDE.
WE WERE GOING TO ORIGINALLY END
WITH SOME GENETIC RESEARCH
FUTURE FORECAST.
I HAD MET WITH MY COLLEAGUES
LAST WEEK TO BE BRIEFED ON ALL
THE BIGGY MER BIG EMERGING ISSU.
THERE'S A LOT HAPPENING AND I
MEAN THAT BRIDGE TO AI
PRESENTATION, I LEARNED A LOT
FROM THAT MYSELF BUT I'M NOT THE
BEST SPOKESPERSON FOR THIS
SCIENCE AND I REALIZED SO
INSTEAD, I THINK THIS ETHICAL
FRAMEWORK THAT WAS DEVELOPED BY
A GROUP OF INDIGENOUS SCHOLARS
IS A MORE FITTING NOTE FOR ME TO
END ON AND IT REALLY ANCHORS
SOME OF THE IMPORTANT LESSONS
THAT ARE NOT UNIQUE OR
EXCEPTIONAL BUT HOW WE APPROACH
RESEARCH FROM A MORE HOLISTIC
PERSPECTIVE SO IT'S WHAT A
COMMUNITY-CENTERED APPROACH THAT
IS GROUNDED IN PARTNERSHIP AND
RESEARCH TOPIC AND MOVING
OUTWARD TO CULTURAL CAPACITY AND
CAPACITY BUILDING BEFORE WE
BRANCH OUT TO SOME OF THE MORE
FAMILIAR RESEARCH ETHICS
PRINCIPLES AND KEEPING EQUITY IN
SIGHT.
SO I HOPE THIS NOT PRESENTATION
WAS RESPONSIVE TO THE REQUEST
FROM THE TRIBAL ADVISORY
COMMITTEE AND I ALSO HOPE SOME
OF MY COLLEAGUES FROM WITHIN NIH
ARE LISTENING AND I DID INVITE A
NUMBER OF THEM BECAUSE IT'S
REALLY ON US TO INTERNALIZE THIS
FRAMEWORK AND TO ENSURE THAT WE
ARE LEARNING THE LESSONS OFFS
HISTORY AND UPHOLDING OUR MORAL
OBLIGATIONS EX DUTIES TO THE
COMMUNITIES THAT WE SEARCH.
SO ON THAT NOTE, WE REALLY LOOK
FORWARD TO DISCUSSION AND
QUESTIONS.
THANK YOU, VERY MUCH.
>>THANK YOU, Dr. BERGER AND
Dr. HULL FOR YOUR
PRESENTATION, I APPRECIATE THAT.
APPRECIATE ALL OF WHY YOUR WORE
HAVE QUESTIONS AND DISCUSSION
ITEMS SO I'LL OPEN IT UP TO THE
REST OF THE TAC.
>>THANK YOU FOR THIS
PRESENTATION.
I GUESS IN OF MY OF -- I WAS
REALLY GLAD TO HEAR A LITTLE BIT
MORE FROM Dr. HULL IN TERMS OF
YOUR BACKGROUND AND EXPERIENCE
AND MOTIVATION FOR THE WORK THAT
YOU ARE DOING.
IT REALLY HELPED PROVIDE CONTEXT
AND WE TALKED ABOUT SOME OF THE
EFFORTS THAT ARE TAKING PLACE
WHEN IT COMES TO ETHICS.
ONE THING I DID WANT TO ASK
ABOUT, BECAUSE I KNOW THE
TERMINOLOGY OR THE RESPECT FOR
SOVEREIGNTY, IS USED FREQUENTLY
AND WITHOUT ANY KIND OF MEAT OR
ACTION BEHIND IT AND I KIND OF
FELT LIKE IN THE PRESENTATION, I
WANTED AND HOPED TO SEE BECAUSE
THIS IS THE ONE I REQUEST WAS
MORE ACTIONABLE.
WHAT ARE THE PIECES THAT ARE
REALLY BEING, I GUESS PASSED
ONTO THE RESEARCHER AND YOU
KNOW, BECAUSE I THINK WHEN WE
LOOK AT BEST PRACTICES, WHEN
COMES FOR RESPONSIBLE DATA
MANAGEMENT AND SHARING, IT
REALLY IS LEFT UP TO THE
INTERPRETATION OF A RESEARCHER
FOR EXAMPLE AND SO FOR ME IT'S
ALWAYS HELPFUL TO SEE SOMETHING
A LIT MORE CONCRETE AND TANGIBLE
AND TO DID YOU HAVE ANOTHER
SLIDE WHAT RESPECT FOR TRIBAL
SOVEREIGNTY REMAINS IN RESEARCH.
>>THANK YOU FOR THAT QUESTION
AND I HAVEN'T DEVELOPED A --
THANK YOU FOR ALL THAT LOVELY,
POSITIVE FEEDBACK AS WELL.
AND YOUR QUESTION IS AN
EXCELLENT ONE.
MY ANSWER IS THAT AT THE MOMENT,
WE'VE REALLY BEEN HANDLING THAT
ON A CASE-BY-CASE BASIS IN VERY
CLOSE CONVERSATIONS WITH MY
COLLEAGUES AND THE TRIBAL HEALTH
RESEARCH OFFICE.
SO THERE'S A LOT OF DIFFERENT
WHAT FORMAL TRIBAL CONSULTATION
PROCESSES LIKE LIKE AND THAT HAS
BEEN A WHOLE CONVERSATION AND
THAT WE'VE BEEN HAVING AND THAT
ARE ACTUAL WILL HE BEEN INFORMED
BY CONSULTATION BUT THAT'S
CONSULTATION WITH A CAPITOL C
AND IT'S A VERY FORMAL PROCESS
AND INITIATED BY THE NIH TO
EXPLORE NEW EMERGING PROGRAMS
AND ISSUES THAT HAVE COME UP.
THEN THERE ARE VERY SPECIFIC
QUESTIONS ABOUT WHAT TO DO IN IT
PARTICULAR STUDIES AND THAT
REALLY DEPENDS ON WHO IS
CONDUCTING THE RESEARCH, WHERE
IT IS TAKING PLACE, AND WHAT THE
RESEARCH QUESTIONS ARE, SO WE'RE
SITTING DOWN WITH INVESTIGATORS
AND FIRST AND FINDING OUT MORE
OF WHAT THEIR PLANS ARE AND
HELPING THEM MAKE THE
CONNECTIONS TO MEET COMMUNITY
ORGANIZATIONS AND NOT TRIBAL
LEADERSHIP AND TO DETERMINING
WHEN MORE FORMAL CONSULTATIONS
MIGHT BE NEEDED BEFORE
PROCEEDING AND JUST WORKING ON
IT IT ON A CASE-BY-CASE BASIS.
IT'S HARD TO DEVELOP A SLIDE
THAT CAPTURES ALL OF THAT AND IN
SOME CASES, WE WANT TO MAKE SURE
IF AN IHS FACILITY IS ENGAGE THE
APPROPRIATE IRB FACILITY OR
PERSONAL OWE RESOURCES AND THE
IHSIRB WOULD BE INVOLVED AND IT
IT'S A COMMUNITIES THAT HAS ITS
OWN TRIBAL IRB OR SOME OTHER
RESEARCH PROCESS, YOU KNOW, WE
WOULD GO TO ENSURE THAT THE IRB
THERE HAD REVIEWED IT AND THAT
LETTER OF APPROVAL WAS IN PLACE
BEFORE WE DO A DUEL REVIEW OR
SEE TO THAT IRB IF APPROXIMATE
APPROPRIATE.
SO WE'RE STILL, AS OTHERS HAVE
SAID, IT'S A LEARNING PROCESS
FOR US AND WE'RE ACCUMULATING
THESE EXPERIENCES AND BECOMING
BETTER CONSULTANTS IN THE
PROCESS.
>>I HAVE A FOLLOW UP TO THAT
AND I KNOW THAT IT'S GRAY AREA
WHERE DATA IS NOT BEING
COLLECTED ON A RESERVATION, FOR
EXAMPLE, AND IT SEEMS LIKE THAT
SORT OF AN AREA FOR RESEARCH
GOING THROUGH A REVIEW PROCESS
BUT THERE'S A GREATER NEED TO
ESTABLISH SOMETHING A LITTLE BIT
MORE FORMAL WHEN IT COMES TO
RESEARCH WITH AI/AM POPULATIONS
IN GENERAL BECAUSE I KNOW WITH
CERTAIN STUDIES IF A INDIVIDUAL
IS GOING TO HOSPITAL FOR EXAMPLE
AND THEY ARE PART OF A STUDY BUT
THEY'RE STILL TRIBAL MEMBERS SO
THEY STILL GO HOME AND RESIDE ON
A RESERVATION AND IT IS STILL
MAYBE STUDY IS TARGETING
AMERICAN INDIANS, ALASKA NATIVE
SPECIFICALLY BUT THERE'S -- I
DON'T KNOW.
I JUST WOULD LIKE TO SEE
SOMETHING AND MAYBE YOU HAVE
SOMETHING A LITTLE BIT MORE
CONCRETE THAT ADDRESSES THIS
KIND OF A SCENARIO WHEN IT COMES
TO RESEARCH THAT IS NOT
HAPPENING ON RESERVATIONS.
>>THAT IS -- I WAS LISTENING
VERY CAREFULLY.
IT'S REALLY IMPORTANT BACKGROUND
AND WE ARE WORKING ON DEVELOPING
RESOURCES, CRITICAL
CONSIDERATIONS DOCUMENT AND THIS
IS THE DOCUMENT TO WHICH Dr.
WILSON HAD REFERRED EARLIER THAT
IS UNDERGOING INTERNAL REVIEW
AND I'M REALLY EAGER TO SEE HOW
THAT CONVERSATION GOES AND I
THINK IT WILL BE AT A FUTURE TAC
MEETING BUT I THINK WE HAVE BEEN
TALKING ABOUT THOSE EXACT TOPICS
AND THERE'S BEEN A SUBGROUP OF
THE TAC THAT HAS BEEN WORKING ON
THAN AND I THINK THAT IS REALLY
IMPORTANT EMERGING AREAS THAT
WE'LL CONTINUE TO TALK TO YOU
ABOUT.
>>THANK YOU.
>>JUST A QUICK ADD FROM A
POLICY PERSPECTIVE.
I WANT TO NOTE, PART OF WHAT WE
DO WITH OUR POLICIES AND BUILD
IN THAT FLEXIBILITY FOR
RESPECTING TRIBAL SOVEREIGNTY.
AND IF YOU LOOK AT THE DATA
MANAGEMENT AND SHARING POLICY
FOR INSTANCE, THE SUPPLEMENTAL
INFORMATION ON IT IT ACTUALLY
SPECIFICALLY INCLUDES THE RIGHT
FOR TRIBES TO ESTABLISH
EXPECTATIONS FOR HOW THEIR DATA
ARE MANAGED AND SHARED.
AND THAT THOSE EXPECTATIONS ARE
ACTUALLY TO BE RESPECTED BY
RESEARCHERS AND SO WE TRY TO
BUILD THESE INTO OUR POLICIES
AND THE FRAMEWORK AND I
UNDERSTAND THERE'S OBVIOUSLY
GOING TO BE LIMITATIONS AND HOW
THESE COME OUT AND SINGLE IRB
POLICIES ARE THE SAME WAY AND
TRYING TO RECOGNIZE TRIBAL
SOVEREIGNTY AND DETERMINING HOW
IRB OVERSIGHT OCCURS AND -- THE
LIGHTS.
I'M JUST GOING TO GO WITH HER
HERE.
I'M GOING HAVE TO TA TALK TO WHO
PLAYS THE ELECTRIC BILLS AND GET
THEM TO DO A BETTER JOB.
WE'VE TRIED TO BUILD THAT INTO
OUR POLICIES AND IRB POLICY FOR
INSTANCE, WE ALLOW FOR AN
EXCEPTION IF IT'S A TRIBAL LAW
AND A REGULATION OR POLICY AND
IT'S BEEN PUT IN PLACE SO ALL OF
THOSE WERE MEANT TO TRY AND PUT
IN THE FLEXIBILITY AND ALLOW THE
TRIBES TO DICTATE HOW THIS GOES
FORWARD.
THERE ARE OTHER QUESTIONS AS
WELL.
>>WE HAVE A QUESTION.
>>I MISSED THE DIPPI BEGINNINGE
PRESENTATION SO MAYBE IT WAS
COVERED.
ONE OF THE THINGS I REALLY
APPRECIATED THAT SLIDE YOU
SHARED AND WITH THE CHECKLIST
AND HIGHLIGHTING INFORMED COP
>>IT WASN'T INTENDED TO BE A
COMPREHENSIVE OVERVIEW OF THE
CONSENT PROCESS AND IT WAS A
SNIPPET OF ONE EXAMPLE AND I
THINK EVIDENCE OF TRIBAL
CONSULTATION, AND THE DIRECT
FEEDBACK THROUGH THAT MORE
FORMAL PROCESS THROUGH LI LISTEG
SESSIONS THROUGH EXISTING
RELATIONSHIPS BETWEEN
RESEARCHERS AND THE COMMUNITY
AND THE CREATION OF THE
COMMUNITY ADVISORY BOARDS I'VE
SEEN A NUMBER OF WAYS THAT THIS
HAS TAKEN PLACE.
I COULDN'T SAY THAT WE HAVE A
FORMAL NIH POLICY EXPECTATION
THAT'S CLEARLY DEFINED BUT WE DO
WANT TO SEE THAT EVIDENCE AND WE
WANT TO HEAR ABOUT THE WAYS THAT
THE TEAM HAS SPENT TIME IN THE
COMMUNITY AND HAS TALKED THROUGH
AUTHORITIES AND GROUPS THAT HAVE
BEEN DEFUND FOR THE COMMUNITY
AND AND THAT DOCUMENTATION HAS
LOOKED DIFFERENT SOMETIMES IT'S
A TRIBAL RESOLUTION AND
SOMETIMES IT'S AN IRB LETTER OF
APPROVAL AND THERE'S DIFFERENT
FORMS I DON'T KNOW IF THERE'S A
MORE FORMAL WAY TO DESCRIBE WHAT
I'M SAYING BUT THE WAY I'VE BEEN
APPROACHING IT IT, IT WAS A
FAIRLY INTENSIVE DEEP DIVE INTO
EACH INDIVIDUAL STUDY AND
LOOKING AT THE COP TEXT.
AND THAT ITEN INCLUDES
DESCRIBING THAT PROCESS
REPRESENTATIVES FROM THEIR OWN
COMMUNITY IF THEY HAVE QUESTIONS
AND THE NATURE OF THE GROUP LIST
HIGH LOOK LIKE AND CONTRIBUTE TO
GO THE RESEARCH BASED ON THAT.
>>SO IT THERE THINKS ANY REQUII
GUESS ABOUT COMMUNITY SHOWING
SOME KIND OF DOCUMENTATION FOR
COMMUNITY CONSENT AND INCLUSION
OF CONSENT FORMS, FOR EXAMPLE.
>>SO, I MEAN, THERE WOULD BE --
THERE ARE DIFFERENT FORMS OF
DOCUMENTATION AND CAN YOU GIVE
ME AN EXAMPLE OF WHAT YOU WOULD
CONSIDER ADEQUATE DOCUMENTATION,
I DON'T WANT TO MISS STATE.
>>I JUST WONDER LIKE WITH NIH
FUNDED RESEARCH, YOU KNOW, IS
THERE RESEARCH WITH TRIBAL
NATIONS IS THERE A REQUIREMENT
THROUGH THE NIH OF GETTING
COMMUNITY CONSENT.
AND GET THE SIGN OFF OF THE
COMMUNITY AND WE CAN CALL THAT
COMMUNITY AND AND WHEN
RESEARCHERS AND IN THAT CONTEXT
EVIDENCE OF THE SIGN OF AS
DEFINED FOR THAT COMMUNITY AND
THAT LEADERSHIP.
DAVE, DO YOU WANT TO JUMP IN
HERE.
>>I WANT TO SAY THAT AS Dr.
HULL HAD MENTIONED THAT THERE IS
A GROWING TREND OF MORE EX MORE
INSTITUTE CENTERS AND OFFICES
BUILDING IN THAT TYPE OF
LANGUAGE AS THEY BECOME MORE
INFORMED AND EDUCATED ABOUT
TRIBAL SOVEREIGNTY AND TRIBAL
COMMUNITY ENGAGEMENT SO WE ARE
SEEING MORE AND MORE AND THEY'RE
AT VARIOUS LEVELS DEPENDING ON
EACH OF THE DIFFERENT SPECIFIC
RESEARCH OPPORTUNITIES.
SOME WILL REQUIRE LETTERS OF
SUPPORT FROM THE TRIBAL
LEADERSHIP AND SO THAT IS ONE OF
THE THINGS, THAT'S WHAT WE
IDENTIFIED AS COMMUNITY SUPPORT
AND LETTERS FROM TRIBAL
LEADERSHIP BECAUSE OF THE
GOVERNMENT-TO-GOVERNMENT
RELATIONSHIP AND SOME OF THOSE
COME FROM ELECTED TRIBAL LEADERS
AND EPICENTRES ENDORSED BY
TRIBAL LEADERS BUT IT DEPENDS ON
THE DIFFERENT RESEARCH
INITIATIVES OF WHAT THE LEVEL OR
HOW MANY DIFFERENT LETTERS ARE
REQUIRED OR REQUESTED IN TERMS
OF THAT SUPPORT.
IT'S GROWING AND I IT'S
IMPORTANT AS AN AGENCY TO
SUPPORT EACH OTHER AND WHEN WE
HAVE QUESTIONS ABOUT PROGRAMS
THAT ARE BEING DEVELOPED NOT AND
THIS IS SOMETHING THAT Dr.
HULL ALSO MENTIONED, THAT WE ARE
CONTACTED BY PROGRAMS USED TO BE
WHEN ISSUES AROSE, RIGHT, WHEN
THERE WAS A PROBLEM, SOMETHING
HAD HAPPENED AND WE NEEDED TO
GET THIS RESOLVED AND WE DID
SOMETHING AND WE NEED TO FIX IT
BUT NOW IT'S MORE ABOUT WE WANT
TO CREATE A PROGRAM THAT IS
INCLUSIVE OF TRIBAL COMMUNITIES
AND WHAT ARE THE STEPS THAT WE
NEED TO TAKE TO BE MORE
INCLUSIVE AND WHAT DO WE NEED TO
THINK ABOUT AND THIS A
STEP-BY-STEP, CASE-BY-CASE
PROCESS AND THE INCLUSION IS
DIFFERENT AND WE HAVE TO THINK
ABOUT DIFFERENT SENSITIVITIES.
WHEN WE THINK ABOUT MATERNAL
HEALTH ISSUES AND INCLUDING
CHILDREN IN STUDIES, THOSE ARE
ALL VERY DIFFERENT LEVELS OF
SENSITIVITY THAT WE HAVE TO
THINK ABOUT SO IT'S DEFINITELY
NOT A ONE-SIZE-FITS ALL WHERE WE
CAN MIX MASS COMMUNICATION TO
THE AGENCY TO INFORM EVERYBODY
ABOUT HOW TO DO TRIBAL WORK AND
TRIBAL ENGAGEMENT SO WE'RE
TRYING TO DO THIS AND WORKING
WITH THE INSTITUTES AND TALKING
ABOUT WHAT ARE THE SUPER
SENSITIVITIES BUT WHAT HAPPENED
TO OUR CHILDREN IN THE PAST AND
MAKING SURE THAT THEY'RE
THINKING ABOUT IT IT WHEN
THEY'RE ENGAGING TO OUR
COMMUNITIES MOVING FORWARD.
SO, THOSE ARE SOME OF THE THINGS
THAT WE'VE BEEN DOING AND
THERE'S A LOT MORE INVOLVED AND
LIKE I WANTED TO JUST QUICKLY
HIGHLIGHT THAT IT IS DEFINITELY
BY A CASE-BY-CASE BASIS.
WITH THAT I WILL STOP AND HAND
IT BACK TO COUNCILWOMAN FRIAS.
>>OK.
THANK YOU.
WE HAVE ANOTHER QUESTION.
>>THANK YOU.
JUST A COUPLE OF COMMENTS
COMMENTS.
FIRST OF ALL THANK YOU BOTH FOR
THE PRESENTATION AND IT'S VERY
HELPFUL AND WE HAVE A LOT OF NEW
MEMBERS AND SOME ARE MORE OR
LESS FAMILIAR WITH RESEARCH
PROTECTION THIS IS GENERAL AND I
APPRECIATE THE HISTORY OF THE
IRB DEVELOPMENT EX ALL THOSE
THINGS AND TRIBAL PIECES AS WELL
AND.
I APPRECIATE YOU BRINGING UP THE
PRINCIPLE OF JUSTICE IF RESEARCH
WHICH HAS BEEN OVERLOOKED FOR
FAR TOO LONG I THINK BECAUSE AS
YOU MENTIONED THE PRE I AM
INRESPECT FORPERSONS NOT DIMINIT
ALL BUT A LOT OF THE OTHER
THINGS YOU TALKED ABOUT ON THAT
LISTED, THE INTERNATIONAL
CONSIDERATIONS WHICH YOU WERE
RIGHT IS VERY APPLICABLE TO
TRIBAL RESEARCH AND MOST OF
THOSE HAD TO DO WITH JUSTICE
ISSUES AND NOT NECESSARILY
RESPECT AND SO, I THINK THAT'S
REALLY IMPORTANT TO BRING UP.
THE OTHER THING I THINK THAT
WITH -- LIKE Dr. WILSON
MENTIONED OR BOTH OF YOU
MENTIONED THAT ONE SIZE CAN'T
FIT ALL BECAUSE IT'S O MANY SO Y
DIFFERENT PLACE THIS IS RESEARCH
CAPACITY SO I KNOW WE'VE TRIED
FOR A LONG TIME TO BE VERY
PROACTIVE WITH EDUCATING OUR
PARTNERS AND ACADEMIC PARTNERS
AND ACADEMIC MEDICAL PARTNERS
WHO ARE MOST LIKELY TO ENGAGE
WITH THE RESEARCH WITH SO THE
UNIVERSITY OF OKLAHOMA, AND THE
HEALTH SCIENCES CENTERS AND WE
EDUCATE THEM ON THE FACT WE HAVE
AN IRB AND THESE ARE OUR
POLICIES AND THESE ARE THE
PROCESSES YOU GO THROUGH SO THAT
WHEN A PROJECT DOES COME UP,
THEN THEY KNOWS THAT WE ARE
HERE'S AND WE DON'T HAVE TO RELY
ON NIH AND TO SAY OK, YOU GUYS,
YOU KNOW, IF YOU ARE GOING TO
WORK IN TRIBES YOU NEED TO
CONTACT SOMEONE, WHO IT MIGHT
BE.
WE WANT TO BE PROACTIVE WITH
THAT SO WE REACH OUT TO THOSE
ACADEMIC INSTITUTIONS AND
RESEARCH INSTITUTIONS AND WE
HAVE RELATIONSHIPS WITH THE
ACADEMIC ERBs SO THEY KNOW IF
A PROJECT COMES THROUGH TO THEM,
THAT IS ENGAGING PRIMARILY
TRIBAL PEOPLE, THEY KNOW TO
CONTACT US AND OFTEN WE ARE THE
IRB OF RECORD FOR THOSE AND SO I
THINK THAT ALSO, SO IF YOU KNOW
WHO THOSE PARTNERS ARE, YOU CAN
REACH OUT TO THEM AND MAKE SURE
SELVES, MAKE THOSE PROCESSES
KNOWN AND MAKE THEM AWARE OF IT
AND NOT JUST HAVE TO RELY ON NIH
OR SOMEONE ELSE TO SAY HEY, YOU
KNOW, YOU NEED TO GO THROUGH
THOSE PROCESSES SO IT'S
INCUMBENT UPON US, YOU KNOW, I
KNOW THIS IS DIFFERENT CAPACITY
BUT AT LEAST HERE IT'S I INCUMT
TO LET KNOW THERE ARE PROCESSES
IN PLACE AND NOT JUST WAIT FOR
SOMEONE TO A, OH, BY THE WAY,
WE'RE GOING TO DO RESEARCH WITH
TRIBES AND YOU NEED TO MAYBE
TAKE A LOOK AT THIS.
THANK YOU AGAIN FOR THE
PRESENTATION.
>>THANK YOU SO MUCH.
I THINK ONE OF THE THINGS THAT I
WANT ODD SHARE WITH THE
COMMITTEE IS IT'S IMPORTANT IF
YOU HAVE ANY QUESTIONS OR
CONCERNS ABOUT THE
INTERPRETATIONS OF THE RESEARCH
POLICIES, YOU KNOW, TO FEEL FREE
TO REACH OUT TO Dr. BERGER AND
HE WOULD BE HAPPY TO SHARE WHAT
IS THE INTENT OF THE POLICY
BECAUSE SOMETIMES WE ALSO COME
TO TERMS OR IN CONFLICT WITH
THAT THAT PEOPLE HAVE DIFFERENT
INTERPRETATIONS OF THE POLICIES
AND WE WANT TO MAKE SURE IT'S
CONSISTENT ACROSS THE AGENCY,
ACROSS THE SCIENTIFIC ENDEAVOR
AS A WHOLE AND WE'RE
INTERPRETING THE POLICIES AS
THEY WERE INTENDED TO BE WRITTEN
AND ENFORCED.
>>IF I CAN'T ANSWER IT IT I
WILL APPROXIMATE PUT YOU IN
TOUCH WITH THE PEOPLE WHO CAN.
WE'LL GET YOU ANSWERED.
>>THANK YOU AND THANK YOU FOR
YOUR COMMENTS.
YOU HAVE MY BRAIN THINKING ABOUT
SOME OF THE THINGS THAT WE CAN
BE PROACTIVE ON OUR PART.
I APPRECIATE THAT.
ANY OTHER QUESTIONS?
OK, I'LL IT TURNOVER TO YOU,
Dr. WILSON.
>>THANK YOU COUNCILWOMAN AND WE
WANT TO AGAIN THANK Dr. HULL
AND Dr. BERGER FOR THEIR
WONDERFUL PRESENTATIONS.
A LOT OF REALLY IMPORTANT
QUESTIONS THAT HAVE EX
APPROXIMATE FROM THIS THAT WE
CAN ALL BE THINKING ABOUT AND
HOPEFULLY NOT TOO MUCH
APPROXIMATE WE NEED TO GET A LOT
REST BECAUSE WE HAVE A FULL DAY
AHEAD TOMORROW AND THE
PRESENTATIONS AS WE BET T GET TE
LOADED INTO THE BOX PLATFORM SO
IF YOU HAVE TIME, YOU CAN GO AND
CHECK THOSE OUT AND IF YOU HAVE
ANY FOLLOW-UP QUESTIONS, PLEASE
FEEL FREEZE TO REACH OUT BACK TO
THE THROW TEAM AND WE WILL GET
RESPONSES TO ANY QUESTIONS AND
YOU MIGHT HAVE ON ANY OF THE
PRESENTATIONS THAT WHERE OUR
INFORMATION WAS PRESENTED TODAY.
SO WITH THAT, IN THE INTEREST OF
TIME WE'VE HAD A WONDERFUL
DISCUSSION, AND IF COUNCILWOMAN
FRIAS IF YOU CAN CLOSE US OUT
WITH A BLESSING THAT WOULD BE
GREAT.
>>OK.
THANK YOU.
THANK YOU EVERYONE FOR ALLOWING
ME TO DO THE CLOSING BLESSING.
AND I JUST WANT TO SHARE JUST A
LITTLE BIT WITH EVERYONE THAT I
AM UP WITH OF THE TRIBAL COUNCIL
MEMBERS HERE FOR PASS KA KNACK'
TRIBE AND IN OUR TRIBAL
COMMUNITIES, WE HAVE A LOT OF
POSITIVE THINGS THAT HAPPEN IN
OUR COMMUNITIES BUT ALSO, WE
ALSO HAVE A LOT OF THINGS THAT
ARE NOT SO POSITIVE AND ONE OF
THE THINGS THAT WHEN I CAME ON
COUNCIL THAT I DIDN'T EXPECT WAS
THE NUMBER OF FUNERALS THAT I
WOULD BE ATTENDING.
IT'S PART OF OUR TRIBAL
LEADERSHIP, I THINK, THAT WE --
COMES WITH BEING A TRIBAL LEA
LEADER.
JUST RECENTLY WE'VE LOST A
1-YEAR-OLD AND -- WE'VE LOST
PEOPLE TO A CAR ACCIDENT AND
WE'VE LOST PEOPLE TO SO MANY,
YOU KNOW, JUST IN THE PAST WEEK
AND SO THESE ARE, I BRING THIS
UP BECAUSE THIS IS ONE OF THE
REASONS THAT I SERVED ON THIS
NIH BECAUSE THERE ARE SO MANY
QUESTIONS WHY OUR COMMUNITY
MEMBERS DIE SO EARLY AND SO
YOUNG AND BECAUSE SOME OF THESE
CAN BE PREVENTED AND SOME OF
THESE FATALITIES CAN BE
PREVENTED SO WE'RE ALWAYS
PRAYING
CAN BE PREVENTED AND SOME O
>>THANK YOU DEAR GOD FOR
EVERYTHING THAT YOU HAVE BROUGHT
US AND I'M GRATEFUL FOR EVERY
SINGLE DAY AND EVERY SINGLE
THREAD AND FOR BRINGING US HERE
TODAY, VIRTUALLY AND IN-PERSON
AND FOR US TO AND AS TO THINK
ABOUT HOW THINK ABOUT AND
COMMUNITIES AND TO BLESS OUR
COMMUNITIES AND WITH SOLUTIONS,
THANK YOU DEAR GOD BLESS OUR
FAMILIES AT HOME AND BLESS OUR
COMMUNITIES AND BLESS EACH OTHER
AND EVERYONE WHO WE WORK WITH SO
WE CAN ALL WORK TOGETHER AND IN
JESUS NAME I PRAY, AMEN.
THANK YOU, EVERYONE.
>>THANK YOU SO MUCH.
AT THIS FOR A VERY ENGAGING DAY
ONE OF THE 2022 NIH TRIBAL
ADVISORY COMMITTEE MEETING AND
WE WILL SEE EVERYBODY TOMORROW.
>>THANK YOU, EVERYONE.