OKAY, WE'RE GOING TO GO AHEAD
AND BEGIN.
GREETINGS, EVERYONE.
MY NAME IS DR. KARINA WALTERS,
THE DIRECTOR FOR THE TRIBAL
HEALTH RESEARCH OFFICE AT THE
NATIONAL INSTITUTES OF HEALTH.
AND I WANTED TO FIRST THANK
TRIBAL LEADERS AND THEIR
DESIGNEES AND EVERYONE ONLINE
FOR PARTICIPATING IN THIS
IMPORTANT CONSULTATION ON
DISPOSITION OF BIOSPECIMENS
COLLECTED FROM TRIBAL
POPULATIONS.
BUT BEFORE WE FORMALLY GET
STARTED, I WOULD LIKE TO
INSLIGHT MR. BOBBY SUMKE, NIH
TRIBAL ADVISORY BOARD MEMBER TO
OPEN WITH A BLESSING AND
STARTING US OFF IN A GOOD WAY.
>> THANK YOU, DR. WALTERS.
IF YOU'LL PRAY WITH ME.
GRACE AND MERCIFUL FATHER, WE
COME HUMBLY WITH GRATITUDE AS WE
MOVE THROUGH THIS SEASON OF
THANKSGIVING AND CHRISTMAS, MAY
WE ALWAYS BE MINDFUL OF THOSE
WHO ARE LESS FORTUNATE THAN WE
ARE AND MAY WE BE GENEROUS
TOWARD THEM SHARING IN THOSE
GIFTS YOU'VE PROVIDED FOR US.
WE ASK FOR BLESSINGS ON THIS
MEETING TODAY, ON THESE PEOPLE
THAT ARE GATHERED TOGETHER, TO
DISCUSS THESE ISSUES OF CONCERN
AND RESPECT AND DIGNITY OF YOUR
INDIAN PEOPLES.
WE ASK WE BE COLLEGIAL AND
RESPECTFUL AS WE DISCUSS THESE
MATTERS, AND JUST BE WITH US
THROUGHOUT THIS SEASON AND MAY
WE ALWAYS BE COMPASSIONATE
TOWARD ONE ANOTHER, PARTICULARLY
DURING THIS TIME OF TRANSITION
IN OUR COUNTRY.
WE PRAY IN YOUR HOLY NAME, AMEN.
>> AMEN.
THANK YOU SO MUCH.
REALLY APPRECIATE THAT.
FOR A FEW MINUTES I'D LIKE TO
TAKE SOME TIME FOR LOGISTICS FOR
CONDUCTING THIS TRIBAL
CONSULTATION BEFORE WE GET
STARTED.
AS WE GO ALONG LINKS AND
RESOURCES RELATED TO THE
PRESENTATION WILL BE POSTED IN
THE CHAT.
WE WILL OPEN UP FOR DISCUSSION
LIVE AT THE END, BUT PLEASE KEEP
YOURSELF ON MUTE DURING THE
FIRST PART OF THE PROGRAM.
AFTER THE OFFICE OF SCIENCE
POLICY, OSP, PROVIDED A
PRESENTATION WE'LL FOLLOW IN THE
HHS TRIBAL CONSULTATION POLICY,
TRIBAL LEADERS HAVE THE FLOOR TO
ADDRESS THE ROOM FOLLOWED BY
THEIR TRIBAL DESIGNEES.
ALL OTHER ATTENDEES WILL ATTEND
IN A LISTENING CAPACITY, UNLESS
INVITED BY TRIBAL LEADER TO
SPEAK ON THEIR BEHALF OR TO
SPEAK ON THE FLOOR.
MORE DETAILS WILL FOLLOW THIS
PRESENTATION AFTER OSP PRESENTS
THE INFORMATION.
SO, IT'S MY PLEASURE TO
INTRODUCE DR. JESSICA TUCKER,
ACTING DEPUTY DIRECTOR OF THE
OFFICE OF SCIENTIFIC POLICY AT
NIH.
IN THIS POSITION SHE HELPS
PROVIDE LEADERSHIP ON A NUMBER
OF POLICY TOPICS THAT IMPACT
BIOMEDICAL RESEARCH, AND SHE
WILL BE PRESENTING TO US TODAY
ON OSP POLICY.
SHE PREVIOUSLY SERVED AS
DIRECTOR OF THE DIVISION OF
BIOSAFETY, BIOSECURITY, EMERGING
BIOTECHNOLOGY, LED WORK ON A
NUMBER OF POLICY TOPICS
INCLUDING NIH GUIDELINES.
ADDITIONALLY DR. TUCKER WAS A
PROGRAM DIRECTOR AT THE NATIONAL
INSTITUTE FOR BIOMEDICAL
ENGINEERING MENTIONING A PROGRAM
ON GENE DRUG DELIVERY SYSTEMS
AND SYNTHETIC BIOLOGY, PRIOR
WORKED AT HHS AND WAS A VISITING
PROFESSOR AT STONY BROOK
UNIVERSITY, CONDUCTING
ENGINEERING EDUCATION RESEARCH
AND LECTURED WITHIN THE
DEPARTMENT OF CHEMICAL AND
MOLECULAR ENGINEERING.
WITHOUT FURTHER ADO, DR. TUCKER,
THE FLOOR IS YOURS.
>> THANK YOU SO MUCH FOR THAT
VERY WARM WELCOME TODAY, DR.
WALTERS, AND YOUR INTRODUCTION.
AND THANK YOU TO ALL OF YOU FOR
BEING HERE TODAY TO DISCUSS THIS
IMPORTANT TOPIC OF DISPOSITION
OF BIOSPECIMENS COLLECTED FROM
TRIBAL POPULATIONS.
THIS IS AN ISSUE OF GREAT
IMPORTANCE TO US AT NIH, AND WE
WELCOME AND VALUE YOUR INPUT AND
FEEDBACK AS WE SOLIDIFY OPTIONS
TO RETURN BIOSPECIMENS IN WAYS
THAT RESPECT TRIBAL SOVEREIGNTY.
SO, NEXT FEW MINUTES, I PLAN TO
FIRST DISCUSSION THE CONTEXT FOR
THIS CONSULTATION, PROVIDING
FIRST BACKGROUND ON NIH, AND
THEN INFORMATION ON OUR RESEARCH
AND PARTNERSHIP WITH TRIBES.
AND THEN I WILL PROVIDE AN
OVERVIEW OF THE OPTIONS THAT NIH
HAS DEVELOPED WITH INPUT FROM
OUR TRIBAL ADVISORY COMMITTEE,
TAC, FOR HOW WE MIGHT RETURN OR
MANAGE OR DISPOSE OF THEM IN A
WAY MEANINGFUL TO TRIBES.
IT IS IMPORTANT TO NOTE WHEN NIH
PURSUES ANY OF THESE OPTIONS,
TRIBES WILL BE FRONT AND CENTER
IN DECISION MAKING.
THEN OF COURSE AFTER I REVIEW
THIS CONTEXT AND THESE OPTIONS
WE'LL THEN BEGIN THE DISCUSSION
PORTION OF THE MEETING, WHICH IS
OUR OPPORTUNITY TO HEAR FROM ALL
OF YOU, GET YOUR FEEDBACK AND TO
ANSWER ANY QUESTIONS YOU MAY
HAVE.
FIRST I WANT TO PROVIDE A BRIEF
OVERVIEW OF NIH AND RESEARCH WE
FUND.
NIH IS THE STEWARD OF THE
NATION'S LARGEST INVESTMENTS IN
CLINICAL RESEARCH.
FOR FY 22 FY ALLOCATED $18
BILLION FOR CLINICAL RESEARCH,
$7 BILLION SPENT ON CLINICAL
TRIALS AND RELATED ACTIVITIES.
WITH THIS VERY LARGE INVESTMENT,
NIH HAS A RESPONSIBILITY TO BE
GOOD STEWARDS OF PUBLIC FUNDS TO
ENSURE THAT WE FUND HIGH QUALITY
RESEARCH TO ENSURE WE ENHANCE
DIVERSITY AND ACCESS IN RESEARCH
AND RESULTS OF RESEARCH.
AND THAT WE PROTECT PARTICIPANTS
WHO SUPPORT THIS RESEARCH WITH
US.
WE'RE INCREASING OUR FOCUS ON
THE INDIVIDUALS AND COMMUNITIES
WHO PARTNER WITH US.
WE REALIZE THEY DEVOTE TIME AND
PARTS OF THEMSELVES,
BIOSPECIMENS, SO WE WANT TO MAKE
SURE OUR WORK TOGETHER IS
MEANINGFUL FOR THEM, THEIR
HEALTH, THE HEALTH OF THEIR
COMMUNITIES.
SO, NIH IS REALLY PRIORITIZING
ACCESS, ENGAGEMENT AND TRUST
MAKING RESEARCH MORE INCLUSIVE
AND ACCESSIBLE TO PEOPLE FROM
ALL WALKS OF LIFE, MEETING
PEOPLE WHERE THEY ARE, ENGAGING
MORE COMMUNITIES AND INDIVIDUALS
AS OUR RESEARCH PARTNERS IN WAYS
THAT ARE MEANINGFUL TO THEM.
AND REBUILDING TRUST IN SCIENCE
ACROSS THE COUNTRY.
HONORING COMMITMENTS TO THE
PUBLIC AND TO RESEARCH
PARTICIPANTS.
AND RETURN OF RESEARCH RESULTS
AND BIOSPECIMENS IS ONE WAY TO
BUILD THIS TRUST.
AND REBUILDING TRUST WITH TRIBAL
POPULATIONS INCLUDES BEING
CULTURALLY RESPECTFUL REGARDING
BIOSPECIMENS, WHAT WE'RE HERE TO
DISCUSS TODAY.
NEXT SLIDE PLEASE.
SO, I WANT TO EMPHASIZE NIH'S
COMMITMENT IS COMMITMENTED TO
STRONG RELATIONSHIP WITH AIN AND
TRIBAL COMMUNITIES, WITH GOOD
COMMUNICATION AND PARTNERSHIPS
WITH TRIBES INCLUDING SUPPORTING
RESEARCH IMPORTANT TO TRIBES,
ENGAGING TRIBAL COMMUNITIES IN
RESEARCH, MAKING SURE WE
UNDERSTAND TRIBAL PREFERENCES
PRACTICE, ENSURING RESPECT FOR
TRIBAL SOVEREIGNTY AND ENSURE
THIS IS NOT ONLY IN OUR POLICIES
BUT WELL UNDERSTOOD TO EVERYONE
CONDUCTING NIH-SUPPORTED
RESEARCH, STRENGTHENING
AWARENESS OF THESE POLICIES.
AND ALL OF THIS LEADS TO WHY
WE'RE HERE TODAY, TO MAKE SURE
WE CAN RETURN OR OTHERWISE TAKE
CARE OF TRIBAL BIOSPECIMENS IN A
WAY THAT MAKES SENSE AND IS
CULTURALLY ACCEPTABLE TO TRIBES,
AND RESPECTS TRIBAL SOVEREIGNTY.
NEXT SLIDE PLEASE.
SO I WANT TO OUTLINE THE
TIMELINE AND PROCESS WE'VE BEEN
UNDERGOING HERE.
STARTING IN JANUARY THIS YEAR MY
OFFICE OSP BEGAN WORKING WITH
TRIBAL HEALTH RESEARCH OFFICE
AND OTHERS AT NIH TO DEVELOP
CULTURALLY ACCEPTABLE AND
APPROPRIATE OPTIONS, AND
CONSULTATION WITH THRO PRESENTED
TO TAC IN AUGUST, AND REVISED
THESE OPTIONS BASED ON THE
FEEDBACK RECEIVED FROM THE TAC
AND HELD A FOLLOW-UP TAC
PRESENTATION AND DISCUSSION IN
SEPTEMBER TO CONFIRM THE
OPTIONS, REVISED OPTIONS, WERE
RESPONSIVE TO THEIR FEEDBACK.
AND THIS WORK IS WHY WE'RE HERE
TODAY, TODAY IS TRIBAL
CONSULTATION.
NEXT SLIDE PLEASE.
SO, BEFORE WE TURN TO THE
ACTIONS THAT WE'VE OUTLINED I
WANT TO REVIEW THE SPECIFIC NEED
AT HAND TODAY, WHAT WE SEE AS
THE GOAL FOR TODAY'S
CONSULTATION.
OF COURSE, NIH RESEARCH CAN
INVOLVE BIOSPECIMENS FROM TRIBAL
POPULATIONS.
AND NIH NEEDS TO HOW TRIBES
WOULD LIKE BIOSPECIMENS TO BE
RETURNED OR TAKEN CARE OF IN A
WAY THAT RESPECTS TRIBAL
SOVEREIGNTY AND CULTURAL
SENSITIVITY.
OUR GOAL REALLY, CONSULTATION
TODAY, IS ULTIMATELY TO DEVELOP
OUTCOME OF THIS, TO DEVELOP A
CONSISTENT SET OF TRIBALLY
ACCEPTABLE OPTIONS FOR NIH TO
RETURN OR OTHERWISE TAKE CARE OF
BIOSPECIMENS COLLECTED FROM
TRIBAL MEMBERS, INCLUDING FROM
INTERNATIONAL INDIGENOUS
POPULATIONS.
NEXT SLIDE PLEASE.
NOW I WANT TO MOVE TO THE NEXT
PHASE WHERE I CAN PRESENT THE
OPTIONS WE'VE OUTLINED FOR
RETURN AND REALLY LOOK FORWARD
TO YOUR FEEDBACK ON THESE.
SO, THIS SLIDE PRESENTS --
PROVIDES FIVE OPTIONS THAT NIH
HAS IDENTIFIED IN PARTNERSHIP
WITH THRO AND THE TAC HOW WE
MIGHT RETURN OR OTHERWISE TAKE
CARE OF BIOSPECIMENS COLLECTED
FROM TRIBAL POPULATIONS THAT ARE
HELD BY NIH.
OUR GOAL WAS TO ENSURE RESEARCH
EQUITY AND RESPECT FOR TRIBAL
CUSTOMS AND PRACTICES.
THESE OPTIONS ARE NOT MUTUALLY
EXCLUSIVE.
AND WE HOPE THAT YOU'LL LET US
KNOW IF THERE'S ANYTHING WE CAN
REFINE, ADD, CLARIFY WHEN WE
TURN TO THE DISCUSSION LATER.
OUR HOPE IS REALLY TO HAVE --
MANY OPTIONS ARE ACCEPTABLE TO
TRIBES AND RESPECT TRIBAL
SOVEREIGNTY.
I WANT TO NOTE THAT OPTIONS A
THROUGH C ARE FOCUSED ON
BIOSPECIMENS BEING RETURNED
DIRECTLY OR INDIRECTLY TO
TRIBES.
AND THEN D AND E ARE OTHER
ALTERNATIVES TO RETURN.
I'M GOING TO READ THESE SINCE I
THINK THEY ARE IMPORTANT FOR OUR
DISCUSSION TODAY.
OPTION A IS DIRECT RETURN OF
BIOSPECIMENS TO TRIBE OR TRIBES.
THE TRIBE OR TRIBES WILL ARRANGE
THE RETURN.
OF COURSE NIH IS POISED TO
ASSIST WITH RETURN AS NEEDED OR
REQUESTED.
OPTION B AND C HAVE TO DO WITH
INDIRECT RETURN.
OPTION B IS INDIRECT RETURN OF
BIOSPECIMENS TO TRIBALLY
DESIGNATED THIRD PARTY
INSTITUTIONS OR ORGANIZATIONS
IDENTIFIED BY TRIBE OR TRIBES.
TRIER BE ON -- TRIBE OR TRIBES
WILL ARRANGE RETURN, NIH
ASSISTING WITH RETURN.
OPTION C IS ALSO INDIRECT RETURN
TO THIRD PARTY BUT INVOLVES
IDENTIFICATION OF ORGANIZATION
BY NIH IN CONSULTATION WITH
TRIBES, AND ORGANIZED BY NIH.
IN THIS CASE NIH WOULD ARRANGE
THE RETURN.
SO AS I MENTIONED OPTIONS D AND
E PROVIDE MORE OPTIONS,
ALTERNATIVE OPTIONS TO RETURN.
OPTION D IS AFTER CONSULTATION
WITH A TRIBE OR TRIBES THE TRIBE
OR TRIBES MAY DESIGNATE NIH AS
STEWARD.
OPTION E AFTER CONSULTATION,
TRIBE OR TRIBES MAY REQUEST NIH
DISPOSE OF THE BIOSPECIMENS IN A
CULTURALLY SENSITIVE MANNER.
NEXT SLIDE PLEASE.
SO, I HOPE THAT GIVES AN
OVERVIEW OF WHAT WE'RE TRYING TO
ACCOMPLISH, AND THE OPTIONS THAT
WE PUT FORWARD HERE TODAY FOR
DISCUSSION.
WE DO HAVE SOME QUESTIONS THAT
WE WOULD LOVE YOUR FEEDBACK ON
DURING THE DISCUSSION PORTION.
AND THE MAIN QUESTIONS WE HAVE,
ALTHOUGH THERE ARE OTHERS, YOU
KNOW, IF THERE ARE OTHER THINGS
YOU'D LIKE TO SHARE PLEASE DO.
DO THE PROPOSED OPTIONS
ADEQUATELY RESPECT TRIBAL
SOVEREIGNTY?
DO YOU HAVE PARTICULAR CONCERNS
THAT NEED TO BE ADDRESSED FOR
ANY OF THE SPECIFIC OPTIONS?
AND ARE THE PROPOSED OPTIONED
SUFFICIENT AS A MENU OR ARE
THERE ADDITIONAL OPTIONS THAT
SHOULD BE CONSIDERED?
OF COURSE, WE'RE HAPPY TO HEAR
ADDITIONAL FEEDBACK AT THIS
CONSULTATION AND WE WELCOME
WRITTEN TESTIMONY ON OFFICIAL
TRIBAL LETTER HEAD UNTIL JANUARY
20, 2025, AS INDICATED IN THE
LETTER SENT ON OCTOBER 30.
NEXT SLIDE PLEASE.
I GUESS THAT'S THE END.
I WANT TO NOTE THAT WE'RE REALLY
LOOKING FORWARD TO THE
DISCUSSION ABOUT THE
OPPORTUNITIES IN THESE AREAS
WITH TRIBAL COMMUNITIES, WE LOOK
FORWARD TO YOUR FEEDBACK AND AT
THIS POINT I WANT TO RETURN THIS
BACK TO DR. WALTERS TO LEAD US
THROUGH THE NEXT STEPS.
THANK YOU AGAIN FOR THE
OPPORTUNITY TO PRESENT THIS TO
YOU TODAY.
I LOOK FORWARD TO THE
DISCUSSION.
THANK YOU.
>> THANK YOU, DR. TUCKER.
AT THIS TIME TRIBAL LEADERS HAVE
THE FLOOR TO ADDRESS THE ROOM.
I'M GOING TO REMIND FOLKS THAT
ALL OTHER ATTENDEES WILL LISTEN
IN LISTENING CAPACITY UNLESS
INVITED BY TRIBAL LEADERS.
THIS ENSURES HIGHEST RANKING
OFFICIAL FROM EACH TRIBE IS
GIVEN THE OPPORTUNITY TO ADDRESS
THE SESSION FIRST, FOLLOWED BY
OTHER ELECTED OFFICIALS, THEN
DESIGNATED BY ELECTED OFFICIAL
TO PRESENT.
SO FOLLOWING ORDER, TRIBAL
GOVERNOR WOULD HAVE THE FLOOR
FIRST FOLLOWED BY TRIBAL VICE
PRESIDENT, VICE CHAIRPERSON, OR
LIEUTENANT GOVERNOR, THEN
ELECTED OR APPOINTED TRIBAL
OFFICIAL AND THEN DESIGNATED
TRIBAL OFFICIAL.
THE FLOOR IS OPEN TO TRIBAL
LEADERS.
IF HELPFUL, DR. TUCKER COULD
POST THE SLIDE OF THE OPTIONS.
AND DR. CALDWELL, IF YOU COULD
PLEASE SLIDE INTO THE CHAT HOW
WHERE PEOPLE CAN FORWARD THEIR
COMMENTS ON OFFICIAL LETTER HEAD
THAT WOULD BE GREAT SO THEY
WOULD HAVE THAT AS WELL.
SO THE FLOOR IS OPEN, AND I KNOW
WE HAVE MR. BOBBY SOMKE AND
BOBBY FREEMAN AND OTHERS.
IF YOU WOULD LIKE TO OPEN UP THE
FLOOR WITH QUESTIONS, I INVITE
YOU NOW.
AND ANY OTHER TRIBAL LEADERS
THAT ARE PRESENT.
YES, CARRIE?
>> GOOD MORNING.
I GUESS MY FIRST QUESTION IS, IS
THIS GOING TO BE AN OPTION
BEFORE THE COLLECTION OF
BIOSPECIMENS?
LIKE ON A QUESTIONNAIRE OR
WHATEVER, WITH THAT TRIBAL
MEMBER, BECAUSE I FEEL LIKE, YOU
KNOW, ESPECIALLY IN URBAN AREAS,
WHERE, YOU KNOW, THEY MIGHT NOT
HAVE A CONNECTION TO THEIR TRIBE
OR -- AND THEY WANT TO HAVE
SOMETHING SPECIFICALLY DONE WITH
THEIR BIOSPECIMENS AFTER
RESEARCH PURPOSES, IF THERE'S
SOMETHING ON THE QUESTIONNAIRE
KIND OF WITH THESE OPTIONS OF DO
YOU WANT YOUR TRIBE TO WORK ON
THE DISPOSITION OF IT OR, YOU
KNOW, THE CENTER WHEREVER THE
SPECIMENS WERE COLLECTED FOR
THEIR INDIVIDUAL LIKE RIGHTS TO
THAT SPECIMEN?
>> THANK YOU FOR THE QUESTION.
YEAH, I MEAN, IN THIS CASE WE
ARE, YOU KNOW, THE MOST
IMPORTANT THING IS THAT WE WANT
TO ENSURE THAT WE RESPECT THE
SOVEREIGNTY OF TRIBES AND WORK
ON IN THE MOST APPROPRIATE
MANNER TO HANDLE THESE
SPECIMENS.
FOR PURPOSES OF TODAY'S
CONSULTATION WHERE BIOSPECIMENS
HAVE ALREADY BEEN COLLECTED,
TRYING TO ENSURE APPROPRIATE
RETURN TO TRIBES, TRIBAL
SOVEREIGNTY AND TRIBAL WISHES,
BUT I WANT TO SEE, DR. WALTERS,
IF YOU HAVE ANYTHING YOU WANT TO
ADD TO THAT ABOUT MECHANISMS FOR
CONSULTING WITH TRIBES
PROACTIVELY.
>> YEAH, THIS WILL BE PART OF
THE -- WE'LL BE ROLLING THIS
INTO THE INDIGENOUS DATA
SOVEREIGNTY POLICY SO THAT FOLKS
AT THE CONSENT PHASE, SOME OF
THIS CAN BE IDENTIFIED EARLIER
ON, AND AS OPPOSED TO KIND OF
NOW BEING IDENTIFIED WITH
REQUEST FOR RETURN OF
BIOSPECIMENS FOR EXAMPLE.
THE INTENTION WAS TO IMMEDIATELY
BE ABLE TO HAVE SOME CLEAR
GUIDELINES IF PEOPLE ARE
REQUESTING DIRECT RETURN OF
BIOSPECIMENS, AND HOW BEST TO
HANDLE THAT IN A WAY THAT HONORS
TRIBAL SOVEREIGNTY.
BUT I DO THINK THIS CAN
CERTAINLY BE ROLLED INTO CONSENT
FORMS AND OTHER MOUs AND OTHER
PROCESSES BOTH WITH TRIBES OR IN
THE CASE OF URBAN FOLKS, PEOPLE
BEING ABLE TO DESIGNATE THEIR
SPECIMENS AS WELL.
SO THERE'S DEFINITELY
OPPORTUNITY FOR THAT.
THANK YOU FOR THAT QUESTION.
OTHER COMMENTS FROM OUR LEADERS?
BOBBY?
>> THANK YOU.
BOBBY SOMKE, OKLAHOMA AREA
DELEGATE.
YEAH, I HAD A QUESTION, WE'RE
TALKING ABOUT SPECIMENS ALREADY
COLLECTED AND IN POSSESSION OF
NIH AND AS YOU MENTIONED MOVING
FORWARD CAN BE ADDRESSED IN
CONSENT PHASE, THAT'S BEING DONE
IN SOME INSTANCES.
WHEN YOU TALK ABOUT ARRANGING BY
TRIBE, SORRY ABOUT THAT, I'VE
GOT PEOPLE WORKING IN THE HOUSE
TODAY AND THE DOGS ARE HAPPY.
>> WE CAN'T HEAR THEM.
>> OKAY, GOOD.
YOU TALK ABOUT THE TRIBES
ARRANGING.
IS THAT INCLUDING THE COST OF
ARRANGING FOR RETURN OF
SPECIMENS?
BECAUSE I KNOW THERE'S A COST
INVOLVED IN THAT TYPE OF
PROCEDURE.
AND THEN ALSO MY OTHER QUESTION
CHICKASAW NATION WHERE I WORK,
WE HAVE BIOSPECIMENS IN NIH
POSSESSION RIGHT NOW, LIKELY
MULTI-TRIBAL INDIVIDUALS
PARTICIPATING.
AND SO WOULD YOU JUST -- HOW
WOULD THAT BE HANDLED?
WOULD YOU SAY THESE ARE
SPECIMENS COLLECTED AT A STUDY
IN THE CHICKASAW NATION OR HOW
WOULD YOU KNOW WHO TO CONTACT
FOR THOSE SPECIMENS PARTICULARLY
WHEN THEY ARE MULTI-TRIBAL
INDIVIDUALS?
>> THANK YOU FOR THAT QUESTION,
FOR THOSE QUESTIONS.
YOU KNOW, I THINK IN TERMS OF
THE COST OF RETURNS, YOU KNOW,
OBVIOUSLY HERE WE'RE TRYING TO
GET AN OVERVIEW OF THESE
HIGH-LEVEL OPTIONS TO ENSURE WE
HAVE A GOOD MENU THAT WOULD
ADDRESS LOTS OF DIFFERENT
SITUATIONS.
IT WOULD DEPEND ON, YOU KNOW,
EACH SITUATION IN TERMS OF COST
WOULD HAVE TO BE DISCUSSED
BETWEEN NIH INSTITUTE AND CENTER
HOLDING THE BIOSPECIMENS AND THE
TRIBE, WHAT ARE THE COSTS OF
SHIPPING BIOSPECIMENS, BORNE BY
THE INSTITUTE OR CENTER, WOULD
DEPEND ON THE BUDGET ABILITY AND
THINGS LIKE THAT.
BUT CERTAINLY THAT WILL BE A
CONSIDERATION.
YOU KNOW, ONE OF THE THINGS THAT
SHOULD BE DISCUSSED IN THESE
CASES.
AND IN YOUR SECOND QUESTION, YOU
KNOW, I THINK THAT THAT'S PART
OF THE REASON WHY WE HAVE SORT
OF TRIBE OR TRIBES IN ALL THESE
CASES, AS YOU ALLUDE TO, YOU
KNOW, IN SOME CASES THERE MAY BE
MULTIPLE TRIBES THAT WOULD HAVE
TO BE -- THAT NIH WOULD HAVE TO
WORK WITH IN ORDER TO DETERMINE
THE TRIBAL PREFERENCES FOR
DISPOSITION.
AND SO I THINK, YOU KNOW, IF YOU
HAVE ANY THOUGHTS ABOUT THAT OR
DR. WALTERS, IF YOU HAVE
ANYTHING TO ADD ABOUT THAT, IT'S
SOMETHING THAT WE'RE AWARE OF,
THAT WOULDN'T NECESSARILY JUST
BE A SINGLE TRIBE THAT WOULD
HAVE TO BE ENGAGED, MULTIPLE
TRIBES, TO BEST UNDERSTAND THEIR
WISHES.
AND THAT WOULD CERTAINLY BE
SOMETHING NIH WOULD BE VERY
COMMITTED TO DOING IN THESE
CASES, I JUST WANTED TO SEE, DR.
WALTERS, IF YOU HAVE ANYTHING TO
ADD.
>> YES, TO THE COST QUESTION YOU
RAISE, MR. SAUNKEAH, FIRST OF
ALL, YES, NIH IS GOING TO DO
EVERYTHING TO PROVIDE SUPPORT
WHERE WE CAN TO TRY TO MAKE SURE
THIS HAPPENS IN A GOOD WAY, IT
DEPENDS ON I.C.s.
THEY HAVE THEIR OWN SET OF
BUDGETS AND ABILITIES TO PROVIDE
THAT SUPPORT BUT WE WOULD WORK
CLOSELY WITH THE TRIBE TO MAKE
IT HAPPEN AND WE RECOGNIZE THAT
IN SOME INSTANCES TRIBES WILL
FINANCIALLY NOT BE ABLE TO, YOU
KNOW, SHOULDER THAT BURDEN.
SO BUT WE WILL WORK CLOSELY AND
IT WILL BE ON A CASE-BY-CASE
BASIS WITH THE TRIBES IN
CONSULTATION WITH THE DIRECT
CENTER OR INSTITUTE THAT'S
FUNDING OR HOLDING SPECIMENS.
ANYTHING ELSE ON THAT?
>> SORRY, I JUST WANT TO DO A
FOLLOW-UP QUESTION.
SO IF WE'RE TALKING ABOUT
SPECIMENS THAT HAVE ALREADY BEEN
COLLECTED BY THE NIH, WHERE
THERE ARE ALREADY MECHANISMS IN
PLACE TO IDENTIFY WHICH TRIBE
THOSE SPECIMENS POTENTIALLY
COULD HAVE COME FROM, OR ARE WE
TALKING ABOUT SPECIMENS THAT
HAVE BEEN IN THE COLLECTION SO
LONG THAT THEY ARE KIND OF
ANONYMOUS COLLECTIONS?
LIKE WHAT WAS THE MECHANISMS
AROUND IDENTIFICATION PER LIKE
RACIAL OR ETHNIC IDENTIFICATIONS
WITHIN THE RESEARCH PROGRAM.
I'M JUST TRYING TO FIGURE OUT
AND TEASE OUT A LITTLE BIT OF
THAT.
>> YEAH, DR. TUCKER?
>> SURE, YEAH, I MEAN, IT IS,
YOU KNOW, IT DEPENDS.
I MEAN, AGAIN, WE'RE TALKING
ABOUT DE-IDENTIFIED BIOSPECIMENS
THAT IN CASES OF MANY TIMES WHEN
WE HAVE DE-IDENTIFIED
BIOSPECIMENS THERE MAY BE THINGS
WE KNOW LIKE THEY WERE COLLECTED
FROM A TRIBAL COMMUNITY, RIGHT,
THAT MIGHT BE PART OF SORT OF
THE INFORMATION WE KNOW ABOUT
THE BIOSPECIMENS THAT IT'S STILL
DE-IDENTIFIED IN TERMS OF THE
INDIVIDUAL, RIGHT?
SO THERE REALLY ARE A WIDE RANGE
OF, YOU KNOW, IT COULD BE A
NUMBER OF DIFFERENT CASES,
WHETHER SORT OF REALLY
HISTORICALLY OLD SAMPLES OR
CASES WHERE, YOU KNOW, WE HAVE
SOME INFORMATION TO INFORM THAT
IT MAY HAVE BEEN COLLECTED FROM
TRIBES.
SO IT COULD BE A NUMBER OF
DIFFERENT CASES.
>> YEAH, MS. FRIEDMAN, TO
RESPOND, A GOOD EXAMPLE WOULD BE
LET'S SAY HYPOTHETICALLY WE HAD
A NUMBER OF OLDER BIOSPECIMENS
TRIBES REQUESTED TO COME BACK IN
THE SOUTHWEST, FOR EXAMPLE, AND
COME HOME.
AND, YOU KNOW, IF THAT WAS THE
CASE WE WOULD WORK WITH THOSE
TRIBES DIRECTLY.
BUT IN THE CASE THAT SOME OF
THESE OLDER BIOSPECIMENS MIGHT
NOT HAVE BEEN LISTED
SPECIFICALLY BY A PARTICULAR
TRIBE LIKE, FOR EXAMPLE, MIGHT
NOT SAY, YOU KNOW, GILA RIVER
BUT MIGHT SAY PIMA, FOR EXAMPLE,
THESE LARGER GROUPINGS, IN THOSE
SITUATIONS WE WOULD WORK CLOSELY
WITH ASSOCIATED TRIBES TO COME
UP WITH MOU AND PROCESS THAT WAS
AGREEABLE TO ALL PARTIES
INVOLVED FOR PROPER CULTURAL
RETURN OF BIOSPECIMENS, WORKING
CLOSELY TO MAKE SURE WE'RE
FOLLOWING TRIBAL PROTOCOLS AND
NEEDS, ON A CASE-BY-CASE BASIS A
LITTLE BIT.
THERE ARE, YOU KNOW, WE DO HAVE
OLDER SAMPLES AS WELL.
ONE OF THE THINGS WE'RE DOING
WITH INDIGENOUS DATA SOVEREIGNTY
POLICY IS MOVING FORWARD TO MAKE
SURE WE'RE UNDERSTANDING LIKE
KIND OF TIME LINE, FOR EXAMPLE,
PROCESSES OF RECONSENT, AND
GETTING SOME OF THOSE ELEMENTS
IN PLACE MOVING FORWARD AS WELL.
SO THAT WILL ALSO BE
COMPLEMENTING SOME OF THIS
MOVING FORWARD.
BUT WE JUST WANTED TO MAKE SURE
THAT WE HAVE SOMETHING IN PLACE
NOW TO BE ABLE TO WORK CLOSELY
WITH TRIBES, IF THERE'S A
REQUEST FOR DIFFERENT
DISPOSITION OF CURRENT HOLDINGS
THERE MAY BE SOME UNIQUE
SITUATIONS THAT ARISE TOO WHERE
WE DON'T HAVE TRIBAL
AFFILIATIONS, BUT WE KNOW THEY
WERE COLLECTED FROM AMERICAN
INDIAN/ALASKA NATIVE PEOPLE BUT
NOT NECESSARILY BY TRIBE SO
WE'LL NOT KNOW WHAT THE TRIBAL
DESIGNATION IS.
WE COULD SEEK YOUR CONSULTATION
RIGHT NOW ABOUT HOW TO HANDLE
THAT.
THIS IS ONE OF THE REASONS WHY
WE HAVE CONSULTATION, ALSO TO
HELP INFORM THE POLICY HERE.
THAT'S AN EXAMPLE THAT I COULD
SEE THAT WOULD POTENTIALLY
ARISE.
DO YOU HAVE SUGGESTIONS HOW TO
ADDRESS THAT?
THANK YOU, MS. FREEMAN, YEAH,
WE'RE TRYING TO THINK OF EVERY
POSSIBLE SCENARIO.
BUT IN THE CASE -- JUST THINKING
ABOUT THIS NOW WE DON'T HAVE
TRIBAL AFFILIATION BUT THEY HAVE
SELF-IDENTIFIED AS AMERICAN
INDIAN/ALASKA NATIVE, IF THAT
CAME UP AS AN ISSUE HOW WOULD
THE TRIBES LIKE TO SEE THAT BE
HANDLED?
>> IF I COULD JUST RESPOND TO
THAT, I THINK THAT IF THOSE
CASES COME UP, AND I'M GOING TO
ANTICIPATE THAT IT'S PROBABLY
NOT GOING TO COME UP VERY
FREQUENTLY, THAT THE QUESTION
GETS POSED TO EITHER THE
DELEGATE FROM ALASKA OR GO
TOWARDS THE IRBs ESTABLISHED
IN ALASKA OR ALASKA NATIVE
HEALTH BOARD AND GET CONSENSUS,
I WANT TO MAKE SURE EVERYBODY
GETS A SAY.
>> UH-HUH, UH-HUH, THAT'S REALLY
HELPFUL.
THANK YOU.
OTHER THOUGHTS, QUESTIONS,
COMMENTS?
ONE OF THE THINGS THAT WE DID,
YOU KNOW, DR. TUCKER, YOU MIGHT
WANT TO ADDRESS A LITTLE BIT TOO
FOR OUR TRIBAL LEADERS WHAT
STEPS DOES NIH PLAN TO TAKE
FINALIZING OPTIONS TODAY, WHAT
ARE THE NEXT STEPS FOLLOWING
THIS MEETING?
>> SURE, YEAH, HAPPY TO TALK
ABOUT THAT.
AS MENTIONED WE DO -- WE WANT TO
CONSIDER EVERYTHING WE'VE HEARD
TODAY, AND ANY WRITTEN TESTIMONY
THAT WE RECEIVED TO THE E-MAIL
ADDRESS THAT WAS POSTED BEFORE
JANUARY 20, AND THEN WE'LL POST
A REPORT OF THIS CONSULTATION
WITHIN 90 DAYS SO THAT'S ON OR
BEFORE MARCH 6, 2025.
AND THEN OUR INTENTION IS TO
ROLL OUT FINAL VERSION OF THESE
OPTIONS ACROSS THE 27 NIH
INSTITUTES AND CENTERS TO ENSURE
THAT THEY ARE ALL AWARE AND CAN
ADDRESS BIOSPECIMENS FROM TRIBAL
POPULATIONS IN THE WAYS TRIBES
HAVE INDICATED THEY FIND
PREFERENTIAL AND THAT RESPECT
TRIBAL SOVEREIGNTY.
THOSE ARE THE INTENDED NEXT
STEPS.
>> ARE THERE ANY TRIBAL
DESIGNEES HERE TODAY THAT WOULD
ALSO LIKE TO EXTEND A COMMENT OR
QUESTION?
>> DR. WALTERS, THIS IS BOBBY
AGAIN.
CAN I ASK A QUICK QUESTION?
>> ABSOLUTELY.
>> THANK YOU.
OPTION D, AFTER CONSULTATION
WITH TRIBES, TRIBES DESIGNATES
NIH AS STEWARD FOR BIOSPECIMENS,
SO WHAT WOULD BE -- YOU'RE
SAYING STEWARD OF BIOSPECIMENS,
WOULD THOSE BE AVAILABLE FOR USE
FOR OTHER RESEARCH PROJECTS OR
ARE THEY JUST BEING STORED OR
WHAT DOES THAT MEAN EXACTLY?
COULD YOU GO INTO MORE DETAIL
ABOUT WHAT WOULD OCCUR IF NIH IS
THE STEWARD FOR THOSE
BIOSPECIMENS?
THANK YOU.
>> DO YOU WANT TO JUMP IN, DR.
TUCKER?
>> SO, YES, GREAT QUESTION.
I MEAN, I THINK THAT THIS OPTION
THAT SOME OF THESE D AND E WERE
EXPLORED BASED ON FEEDBACK FROM
THE TAC AND THOSE DISCUSSIONS
ABOUT THE NEED FOR OTHER OPTIONS
IN CASE RETURN IS NOT WHAT'S
PREFERRED BY THE TRIBES.
AND SO THIS ONE DESIGNATING --
YOU KNOW, IF THE TRIBE WISHES TO
CONTINUE TO DESIGNATE NIH AS THE
STEWARD FOR THE BIOSPECIMENS, I
THINK, YOU KNOW, IN THIS CASE,
AGAIN, WE WOULD WANT TO WORK,
YOU KNOW, LOOKING AT THE
SPECIFIC SITUATION, WE WOULD
WORK WITH THE TRIBES TO -- OR
TRIBE TO DETERMINE WHAT
STEWARDING MEANS TO THEM, RIGHT?
AND WE WOULD RETAIN AND HOLD THE
SPECIMENS, THAT'S THE INTENTION
OF THAT OPTION, BUT IF TRIBES
WANT IT USED FOR FURTHER
RESEARCH WITH TRIBAL
CONSULTATION, YOU KNOW, THAT
COULD BE AN OPTION, RIGHT?
SO I THINK THAT THOSE TYPES OF
OPTIONS WOULD HAVE TO BE
EXPLORED BASED ON THE SPECIFIC
CASE AND, AGAIN, BASED ON THE
TRIBE'S WISHES OF HOW NIH SHOULD
BEST STEWARD THOSE BIOSPECIMENS
MOVING FORWARD IF THAT OPTION
WERE THE PREFERENCE FOR THE
TRIBE.
>> JUST TO BE CLEAR, I THINK
ALSO, MR. SAUNKEAH, IF WE'RE
HOLDING IT DO WE GET TO SHARE
IT, AND THE ANSWER IS NO.
WE WOULD BE FOLLOWING TRIBAL
SOVEREIGNTY, DATA MANAGEMENT
PLAN IN PLACE, AND DATA ACCESS
PLAN THAT WOULD BE IN PLACE.
AND THAT COULD BE DETERMINED --
THAT IS DETERMINED BY THE TRIBE
WHAT THEY WOULD PREFER.
AND, YOU KNOW, IF THEY SAID WE'D
LIKE TO KNOW EVERY TIME A
REQUEST IS MADE FOR THIS DATA,
THIS WILL BE THE PLAN IN PLACE
FOR REVIEWING THAT, AND WE --
IT'S RESTRICTED ACCESS AND, YOU
KNOW, WHATEVER PARAMETERS THE
TRIBE NEEDS TO PUT ON THAT WOULD
BE HONORED AND WOULD BE PUT IN
PLACE.
SO, THAT'S FIRST AND FOREMOST.
SO BECAUSE IT'S HOUSED HERE AND
IT'S ON LOAN OR STEWARDED HERE,
IT'S NOT -- IT WOULD NOT BE FREE
FOR ALL AT ALL.
IT WOULD HAVE TO BE A PROCESS, A
DATA MANAGEMENT AND ACCESS AND
SHARING PLAN THAT IS TRIBALLY
APPROVED AND SUPPORTED.
THAT WE WOULD BE HONORING.
>> YEAH, JUST TO ADD TO THAT,
YOU KNOW, ABSOLUTELY TRIBES
WOULD DETERMINE HOW THE
BIOSPECIMENS CAN BE USED AND
DIRECT CIRCUMSTANCES IN THIS
OPTION FOR THE BIOSPECIMENS.
>> I REALLY APPRECIATE THAT
BECAUSE, YOU KNOW, THIS IS --
IT'S DIFFICULT, DIFFICULT FOR
NIH, YOU KNOW, TO DO THIS WORK,
RIGHT?
TO IDENTIFY EVEN WHO TO CONTACT,
YOU KNOW, IN SOME CASES, WHAT
TRIBE, HOW DO YOU GO ABOUT
FINDING SOMEBODY, SO I REALLY
APPRECIATE THE THOUGHTFULNESS
THAT'S GONE INTO THIS.
I FEEL LIKE THIS IS A PRETTY
COMPREHENSIVE OPTION LIST AS
WELL, AS DR. FRIMIN MENTIONED,
WHAT I REALLY APPRECIATE IS THE
CONSTANT GOING BACK TO
CONSULTATION WITH CONSULTATION,
WITH CONSULTATION, WITH THE
TRIBE, SO THERE'S A LOT OF
FLEXIBILITY BUILT INTO THIS.
THERE ARE OPTIONS, BUT
UNDERSTANDING THAT, YOU KNOW,
DIFFERENT TRIBES WILL HAVE
DIFFERENT IDEAS AND DIFFERENT
WAYS THEY WANT TO HANDLE THIS
PARTICULAR ISSUE BECAUSE IT'S --
I KNOW IT SAYS BIOSPECIMENS BUT
THAT DOESN'T TELL EXACTLY WHAT
THAT IS BECAUSE THOSE ARE
PEOPLE'S STORIES, TRIBE'S
STORIES, SO IT'S MORE THAN JUST
THE BIOSPECIMENS THAT WE'RE
TALKING ABOUT.
SO I REALLY APPRECIATE THAT
RESPECT THAT YOU'RE SHOWING, YOU
KNOW, BY EVEN HAVING, YOU KNOW,
AN OPTION THEN, YOU'RE GOING TO
DO FURTHER CONSULTATION WHICH
EVER OPTION A TRIBE CHOOSES.
SO I REALLY APPRECIATE THAT.
THANK YOU.
>> THANK YOU SO MUCH.
WE REALLY APPRECIATE YOUR
THOUGHTFUL FEEDBACK.
THANK YOU.
>> ANY OTHER COMMENTS OR
THOUGHTS THAT YOU WOULD LIKE TO
SHARE?
COUNCILMAN FRIMIN OR ARE THERE
ANY TRIBAL DESIGNEES AS WELL
THAT ARE ONLINE?
THANK YOU, COUNCILWOMAN.
OKAY.
SEEING NONE, SOUNDS LIKE WE'VE
MOVED TO THAT POINT WHERE WE'RE
READY TO MOVE FORWARD.
WE WILL PLEASE KEEP IN MIND
THAT, YOU KNOW, WE HAVE
OPPORTUNITY FOR COMMENTS ON THIS
PROCESS, SO PLEASE BE SURE TO
SUBMIT YOUR COMMENTS, SHEILA
CALDWELL HAS POSTED IN THE CHAT,
DR. CALDWELL, WHERE YOU CAN
SUBMIT COMMENTS BEFORE JANUARY
20, 2025 BY E-MAIL NIH.GOV,
THAT'S ONLINE.
NIH WILL PROVIDE A FINAL REPORT
OF THE OUTCOME WITHIN 90
CALENDAR DAYS OF THIS
CONSULTATION AND ANY DECISIONS
MADE AS A RESULT OF THE
CONSULTATION WILL BE DONE ON OR
BEFORE MARCH 6, 2025.
I WANT TO THANK YOU ALL FOR YOUR
TIME AND INPUT FOR THIS TRIBAL
CONSULTATION.
AND WE ARE OFFICIALLY DONE.
SO THANK YOU VERY MUCH, AND LOOK
FORWARD TO HEARING MORE FROM OUR
COMMUNITY.
AND MANY TRIBAL COMMUNITIES OUT
THERE.
THIS IS VERY IMPORTANT.
THANK YOU, DR. TUCKER, FOR YOUR
PRESENTATION.
>> THANK YOU SO MUCH FOR THE
OPPORTUNITY.
REALLY APPRECIATE IT.
>> THANK YOU ALL.
>> THANK YOU.