National Institutes of Health (NIH) Tribal Consultation 6/24/2019

National Institutes of Health (NIH) Tribal Consultation 6/24/2019


Good afternoon. My name is Dr.
Monica Yellowhair. I am a research assistant at
the University of Arizona Cancer Center, and I also
work with the All of Us Research Program for
the Native American outreach in the region. My name is Ashley
Johnson, and I am [INAUDIBLE] Band of Ojibwe
[INAUDIBLE] tribal development. Hi. I’m Chris Hemming and I work
at the National Institutes of Health. Hi. I’m Gwynne Jenkins. I’m chief of staff for the NIH
All of Us Research Program. Dave Wilson, director of Tribal
Health Research Office at NIH. Hi. I’m Gwynne Evans-Lomayesva. I’m Hopi, and I’m a researcher
at the Policy Research Center NCAI. Good afternoon. Good afternoon. I’m Dr. Yvette Roubideaux. I’m the director of the
Policy Research Center at the National Congress
of American Indians. And thank you all
for being here. Hello. My name is [? Annette ?]
[INAUDIBLE].. I’m a member of
[INAUDIBLE],, but I used to work with [INAUDIBLE]. Good afternoon. My name is Steve Hafner, and
I am the research scientist for the National Missing
and Unidentified Persons. Christine Crossland with the
National Institute of Justice in the Department of Justice. [INAUDIBLE] sole governance
in [INAUDIBLE] Tribe. Good afternoon. Travis Lane. I’m the director of the Inter
Tribal Council of Arizona. Gloria Simeon, the Orutsaramiut
Traditional Native Council that’s in Alaska. Hi. I’m Abigail Echo-Hawk,
assistant to the Pawnee Nation of Oklahoma, the director
of the Urban Indian Health Institute, chief research
officer to the Seattle Indian Health Board. I’m also a member of the tribal
advisory group for the All of Us Research initiative. Good afternoon. My name is Tim
Stewart [INAUDIBLE] OK. And again, I want to invite
everybody to the table. You can fill your space
over here on the table. I’m not sure if you
think you’re going to be required to speak
if you sit at the table, but it’s up to you entirely. So I have a couple of reminders. We’re going to stay the
total time of the session. There is an evaluation form. I forgot to ask you to fill
this out in our early session. So if you still
have your packet– and there’s several
of you that are here that were here this
morning– if you could maybe fill that out beginning with
the session from this morning. But also, we have one
for this afternoon, so please fill out
your evaluation form. Again for the people
who are on the web, there is a section
on the web page for you to be able to send in
your questions or comments. And then also, we will
take comments emailed to us at [email protected] So please let us know what you
think as it’s occurring to you. And so I do want to remind you
that this session is closed to the press, but our session
is also being recorded, so we have the
benefit of others that want to be able to view it– not view it, but to
hear it at a later time. And it will be posted
on the NIH website and accessible by
tribal members to help inform various conversations. So the consultation
process, if you didn’t know, originates from
an executive order that a couple of presidents
ago signed and other presidents continue under executive memo– presidential memo– and
has not been revoked. Hopefully, it won’t be. And so the consultation process
requires the federal government in a government-government
relationship with tribes to reach out to tribes and gain
their input on different policy issues that affect us. And so I’m very happy to report,
as a member of the NIH Tribal Consultation
Advisory, that we have articulated a process for
how that’s done through NIH. And obviously, it’s
a work in progress. It can always be
improved, and we’ll continue to get that input. But the consultation process
that we’ll follow today under HHS Federal
Consultation Policy is presenting the
protocol and has been trying to ensure that
the highest ranking official from the respective tribes
is given the opportunity to address the session first,
followed by other elected officials. And then when you do speak,
if you can just acknowledge who you are, your tribe. And again because we don’t
have a really audience, I don’t think we’re going
to be losing anybody today, but we do go through
the tribal leaders first, and then work
our way through. Our earlier session, we used
that practice and everybody who wanted to speak got
the opportunity. –is that …my genes are… I have a predisposition to
certain health conditions. I have family
members– generally, we go for those past 60
years of age, heart disease and diabetes. I’m vegan. I’ve been vegan
for 10 years to try to fight out high cholesterol
and blood pressure. I’ve got high blood
pressure and cholesterol if I don’t take of
it and focus on it. And I also run my butt off. I run about 50 miles a week,
even at this stage of my life, to try and ward off those
kind of health conditions. And so rather than run
hard or work out hard, I want to work out smart. I want to figure out
what specifically it is that I have to do
based on my human genome, and what are the environmental
factors or conditions that might predict
whichever happens– most importantly,
my life expectancy. And so this really,
I believe, has a lot of promise
for Indian country to affect some of
the chronic diseases. I will say right off the bat
because it might be an elephant in the room is that sometimes–
and I said this this morning– you know, even though
our advisory committee has advised NIH,
sometimes some things have been lost in
the translation, so we have to say it repeatedly
and over and over again. But I do believe that they
are genuine in wanting to understand our
needs in Indian country to incorporate our input. So the consultation
is very important so that they hear from us. And that doesn’t
mean it’s perfect. By no means am I giving
a broad endorsement. And I understand that the
research did start before us and started some level
of data collection. But based on our input,
they are incorporating that, and they’re take a
step back, and they’re revisiting and revising how
they’re going to approach. And this consultation
is an example of that. This is the first
step in us being able to give from
Indian country, very clearly our
position of how we feel it’s appropriate
to do data collection on our tribal citizens. And so I hope that our
input is rich, and full, and in a positive sense. And so if you see something
that you didn’t like on how it’s been implemented
or if you have got concerns on how research has been done
before, please express it, but also please
be mindful of this is our opportunity to shape
how we want it to happen. So try to do it in a way that
can give us recommendations and NIH recommendations for how
it should happen going forward. And so with that, I would like
to hand it over to Dr. Tabak. Just a little
anecdote, Dr. Tabak represents NIH on the HHS
Secretary Travel Advisory for which I serve, and has
been for a number of years. So that’s how we became friends. And I remember– and I told
this story this morning– is that Indian
country knows some of the reasons why we have
some of the worst outcomes statistically, right? And we had been hammering tribal
leaders across the country to explain this to HHS. And I actually saw
that light bulb come on when Dr. Tabak fully
appreciated and understood that, and articulated
it back to us. And as a result, NIH
has prioritized research related to historical trauma. And so I really appreciate that. And so that to me is an
example that if they listen, and they invite us,
and we express it, that there’s a chance that
it might be incorporated. So I really do value your input. Hopefully, we get
really good, rich input. With that, Dr. Tabak. Well, I’m going to go over there
so I can see your presentation. OK. Well, Chairperson
Payment, I want to thank you so very much
for both your overview, which is actually better
than my presentation, so keep his overview
in mind, but I do appreciate the privilege
of being able to address all of you today. I want to begin just
with a definition, which I think many of you
already appreciate, but is a starting point to describe
what precision medicine is. The simplest way to
describe precision medicine is for you to look at me for two
seconds, as bad as that sounds. This is precision medicine in
its earliest, crudest form. If I gave you these glasses,
you wouldn’t see very well with them because they are
designed for my very, very poor eyesight. It’s an example of
precision medicine. Now we can do a lot
better than that, but this is a starting point. And so as this slide
indicates, this is an approach that is emerging
which takes into account basically three things– lifestyle, so a vegan
lifestyle, 50 miles a week. That’s impressive, OK. Your genes, and we don’t
have much choice about those. You know, we’re born with those. And then your environment. And that intersection is
really, really important. And so what we want
to be able to do, we want to be able to
understand that intersection, and then tailor approaches
either for prevention and/or intervention, taking into
account those unique attributes that each one of you bring
to the table, so to speak. Now, the All of Us
Research Program is really unprecedented. We are seeking to engage
over 1 million volunteers. These individuals will
be our research partners in the truest sense. And importantly, this
group of individuals– this group of
research partners– will reflect the broad
diversity of the United States. Most biomedical
research studies are conducted on people
who look just like me. This is what biomedical
research typically does. And obviously, I don’t reflect
the diversity of this nation. And what works for me may
not work for one of you. And it may not work because of
those three different elements that I spoke to a
few moments ago– genes, environment,
and lifestyle. And so each one of us
brings something different, and that’s why we
need to understand that in a relationship. Our research partners
will provide data on an ongoing basis. This is voluntary, of course. And the data will inform a
variety of research studies. This launch began
in May of 2018. And so far, about 245,000
people have started the process. And a bit over
150,000 individuals have completed all steps
of the initial protocol. Now very importantly, over
half of these individuals are members of racial
and ethnic minorities. This group of participants
or research partners is going to be unlike any
other group ever assembled in this country. Now again, we’re doing this
to accelerate health research and medical
breakthroughs to enable individualized prevention, which
is really, really important, but also treatment
for all of us. That’s the gist of what
we’re trying to do. So the goal is to oversample– to purposely enroll
as many members of historically underrepresented
groups in biomedical research to ensure that any benefits
that are derived in fact benefit all groups,
including people who live in rural
communities, individuals from sexual and gender
minority communities, individuals from racial
and ethnic minorities, and individuals from
tribal communities. At present, we are only
enrolling individuals who are over the age of
18, although in the future, children will be enrolled. We are not able to take anybody
who is currently incarcerated. But importantly,
you are not excluded because of any
pre-existing health issue. As many of you know for
most scientific studies, they look for a very narrow
window of individuals. They either have to
be very, very healthy or they have to have
only one disease. Well, that’s not the
way most people are. They have a whole range of
issues that they deal with. And because we want this
to be representative of the entire nation, there
is no precondition that eliminates you from this study. Now very importantly, American
Indian and Alaska Natives are not being actively
recruited to this study. Our All of Us
partners are currently prohibited from active
recruitment of American Indian and Alaska Natives. However, we have
had individuals who have signed up on
their own, and then have after the fact,
self-identified as being American
Indian or Alaska Native. So we are not turning anybody
away who chooses to sign up, but we are not
actively recruiting. Please. Just so that we don’t
misinterpret what he said is we have very
strongly advocated that active recruitment not
happen with tribal communities until consultations happen. And so we’re not
purposely excluding them for any other reason other than
they’re respecting our request to do consultation first. The other thing
that we were advised in a previous conversation
was that the use of the data will be compartmentalized
for any data that has been collected up until
now from individual American Indians. And so the whole concept
of individual Indian versus citizens of
respective tribes– those as are citizens
and our jurisdiction over our citizens– was something that took
a little bit for us to get to understand, but I
think they understand that now. But any data that has been
collected will be segmented. And we’ll probably
somewhere down the road talk about how that
might be or may not be incorporated in
the final research. Thank you very much for
those clarifications. And so again, building on
what the chairperson has said, there is in fact a data browser
that’s available to the public, but it has no ability to
analyze any of the data by race, ethnicity, tribal
affiliation, or zip code. This was in great part
due to the recommendations that the tribal advisory
committee at NIH gave to us. And so even though this
browser is available, we have these
delimiters on it because of respect for the
discussions that we’ve had with the [INAUDIBLE]. So what are we going to ask
our research partners to do? It’s summarized in this slide. Obviously, they start by raising
their hand and enrolling. To do this, they have to
have an informed consent. And as part of this, they
will authorize access to their electronic
health record. They are then provided with
online, a series of surveys. And then if they choose
to, they can have a series of physical measurements taken. And if they choose to, they
can provide biospecimens– blood typically, saliva, urine. And they could also
allow us access to wearable and digital apps. Now, my 47-year-old watch
doesn’t count, but some of you probably– well, it was my
engagement gift from my wife- but some of you have
these app things. And access to that, of course,
has very valuable information. Now very importantly, the
bottom line on the slide– “participants can choose
to complete some or all of the available activities. Some participants have already
chosen to answer surveys, but have decided they don’t
want to provide measurements and biosamples.” And that’s perfectly fine. Some information is better
than no information. Now, data access is
very, very important, and it’s something
that we have discussed and no doubt we’ll
continue to discuss. So let me just review
quickly the principles that we’re following. We want to provide broad
access, but in a very safe and controlled manner. Well, why do we
want broad access? Because we want
as much scientific brainpower looking at challenges
and questions as possible. Well use a so-called
data passport model, meaning that access
to data will be granted by peers by different
levels of requirement and need. The data use will be audited and
it will be reported publicly. Everything will be
open and transparent. The data will be stored and
used in a secure enclave. Importantly, the data
cannot be downloaded. It can only be used within our
secure enclave in the cloud. So all the compute will be
done in the cloud with tools. It can’t be downloaded, and put
on your own personal server, and so forth. A very important
feature of this, and something that we’ve
given much thought to, but we still need
additional input please, is the potential for
stigmatizing research. We feel that
transparency on data uses will go a long way
in preventing this, but we also will require
regular assessment. Consortium researchers will
have no special or early access to the full dataset. Now again, the bottom
line on this slide. I’m often asked,
who owns the data? The “oversight of
data access is owned,” if you will, “by two groups
in our governance model– the Committee on
Access, Privacy, and Security and the
Research Access Board.” And there will be members of
American Indian and Alaska Native communities on the
Research Access Board, so voices from your
communities will absolutely be heard with regard to the
oversight of data access. Yes, please? So you’ve heard me
say this before, but I’m going to formally
say it in the consultation is I know of one other
area that collects data across different
racial ethnics and it’s a national dataset. And it’s the National Center
for Education Statistics. And so to gain access to that– you know, when I was at
dissertation level writing my dissertation, I didn’t
have direct access. So basically, there
are superusers that are trained and
certified for access. So my dissertation–
the quantitative person on my dissertation committee
was one of those persons. And so the way that I
gained access to the dataset is she had to log in,
and then she trained me on what I could
and could not do. And the dataset
didn’t allow you to do anything you can’t do anyway. And then like you said,
it couldn’t be downloaded. It couldn’t be exported. And in being one of
those superusers, she was trained on ethics
and the use of data in racial ethnic populations. One of the main
reasons for this is because there was an
earlier stage when reporters were getting to it. And they were coming
to spurious conclusions based on a limited level
of knowledge of what they were even looking at. And so I don’t know
if there’s been any thought about that,
but certainly people who have access to the dataset– broader access to the datasets– should have some level of
training and certifications in the appropriate use of
it and with the ethics. Thank you. And in fact, that
leads very well into the next description,
which is still in draft because we’re still
working through this. We envision three
separate types of users, so it’s somewhat similar
to what you described. There will be public
users who will have access to the data that has minimal
risks to anybody because it’s just aggregate. There are no identifiers. This is the sort of
thing that anybody should be able to access. Then we’ll have people
who are registered users. So this intermediate level,
so done because these data have some risks of identifying. And they will need
a formal account to be able to access the data. And that access will be
logged and may be audited. But then the most
highly sensitive data, that can only be accessed
in a controlled way, sort of like your
superusers, if you will. And they must receive
direct approval from the Research Access Board
to access to controlled data. So the most potentially
sensitive information, that will be under strict
control by the Research Access Board. And certainly, the
experience that you have with the so-called
superusers who were trained specifically
in ethics, obviously that makes a lot of sense. And again, this is all a draft
and things of that nature can be incorporated. I would recommend– so
in my dissertation phase, and I think this might be
true for other dissertation students, but in
our program, we had to become CITI
research certified. And so I would
recommend if there’s any chance of risk of
identifying research participants or even
categories of participants that at the registered
level, they should have to have some certification. Formal, right. OK, thank you. Now, let’s just talk about
the timing of data release. First to reiterate
what’s available now at this moment through
the so-called public data browser, which is
a beta version, it only provides summary
statistics about the dataset. It does not include
any information about American Indian
or Alaska Natives whatsoever, again with thanks
to the NIH Tribal Advisory Committee for that input. Future versions will
likely include some sorting by race, ethnicity, and
sexual and gender minorities, but still there will be no
American Indian or Alaska Natives as a separate category. We will have to work through
the specifics of that, but during this
period, there will be no specific point to American
Indian or Alaska Natives. Now sometime in the
winter of 2019, 2020, we’ll release the first version
of the All of Us dataset and the first set
of researcher tools. It will include
survey, measurement, and electronic health data. At that time, we will begin to
generate genomic data– that is data related to your genes,
the composition of your genes. But today, we have no genotype
or sequence data from anybody. So that hasn’t started yet
for anybody in this study. We’re projecting
2021 and beyond. We envision that there
will be additional data types, including lab test
data and linkages perhaps to external datasets. Again, these are
just guidelines. The bottom line
here on the slide– “all release dates are dependent
on security and usability testing.” We won’t go to the
next step until we’re absolutely confident on the
security issues, and of course, on the usability. So now, I’d just like to
briefly summarize for you the consultation process
that we’ve been engaging in and what we hope
will be next steps. We did form a Tribal
Collaboration Working Group to provide
input on how best to collaborate with
American Indian and Alaska Native communities. We have planned a series of
tribal consultation sessions in several of the IHS
regions during this summer. This is the second consultation
that I’ve personally participated in and
one listening session, so I’ve been seeing a lot of the
country in the last few weeks. These consultations
will be supplemented by additional
listening sessions. And if any of you have
recommendations for ones that we may not yet have on our
radar, please do let us know. We’ll review all of the
input that we obtain. We will make changes
as appropriate that apply to tribal
participants and their data. And importantly– and this is
the other place that we would really value your input– how can we best create tribal
partnership opportunities here? How can we work with
your communities so that this work
maximizes advantage to members of your nations? So per the consultation
process, there was a “dear tribal leader”
letter and framing letter that had been sent out. There was a Federal
Register notice. The process was informed by
this report of the Tribal Collaboration Working Group. Versions of this are
available electronically at the website that
is listed here. We have been in Sacramento. We’re here today, obviously. We have on the books
to go to Spokane, to Washington, and Denver. We’ve also had the listening
sessions that are listed here, with more to be had. And as Chairperson
Payment alluded to, there was a webinar. And that was captured
electronically. And you can access
it on that link. And I believe there
are also summaries– a summary sheet– do
we have those here– of the webinar. In case anybody doesn’t want
to listen to the whole webinar, we have a short summary of that. The TCWG report overview
is very comprehensive. And I won’t go through
this in any detail other than to hit the high points,
all of which I’m sure are self-evident to you. Well, first of course is that
we need to attend to and respect tribal sovereignty. And we need to acknowledge
the American Indian and Alaska Native experience
with the government. We need to include
tribal representatives in All of Us governance areas. And we are doing that throughout
the different areas listed there. We appreciate that we have to
handle biospecimens properly, we have to train researchers
on cultural sensitivities, and support research
questions that are important to tribal nations. Again, your input on
which questions those are would be most valued. We have to continue
to remain responsive. We can’t just come here,
and consult, and say, great. Now, we’re done. This is going to be
a continuous process. We understand that. This is a marathon to use the
running metaphor, not a sprint. And we are in this for
the long, long game here. We intend to hire one or more
dedicated tribal liaisons. And we will continue to ask
communities whether or not there is– you know, what
scientific questions do you want to see addressed
using these resources? And we also want to
let tribal nations know what the program has done as
a result of the consultation process. So again, the bottom
line on this slide– “All of Us could be
of potential benefit to tribal nations
and individuals, and could become a model
for positive, bidirectional partnerships on research between
the NIH and tribal nations.” That’s what we’re aiming for. That’s what the goal is. And I think if we all
continue to work together, we’ll be able to
accomplish that. So these are just
some questions that have occurred to us based upon
feedback that we’ve received. And I’m just listing them here. I’m sure you have many
more, and we welcome them. Obviously, the
program recognizes that there are many
unique considerations that we need to engage in when
partnering with tribal nations. And we would be very
interested in knowing what you feel are best practices
for these types of initiatives. The TCWG report
outlined many points. There may be some you support. There may be some that
you disagree with. Knowing that would be valuable,
whether you agree or disagree. All of that input would
be very, very useful. This has already been alluded
to by the chairperson. How do you recommend
we handle the issue of tribal affiliation? What do we do with
individuals that have enrolled independently
and who self-identify? What are the major
research questions that are of most interest
to your nation or community? How can we help advance
research conducted by members of tribal nations? If we don’t engage
tribal nations to do some of this
research, then we are not reaching our
full potential here. And this should be a
wonderful opportunity that we need to make happen. How should the
program collaborate with tribal nations,
clinics, and organizations to enable American Indian and
Alaska Native participation in this program? Are there initial
pilot partnerships that we should
consider as taking a step in that direction? Now, we’ve heard over
the past several weeks from both listening sessions
and formal consultations some things. I’d just like to
quickly summarize what we’ve already heard. Obviously, please
amplify, agree, disagree, and add to this list. Under the general heading
of cultural respect, understanding, and
trust, clearly there is great importance of
acknowledging past harm and trauma from previous
so-called research. Differing beliefs and
viewpoints from different tribes will certainly influence their
participation in research. We’ve heard loud and clear
that the Tribal Epidemiology Centers would be critical
partners for All of Us. And indeed, several
individuals affiliated with those epidemiology centers
are on our Tribal Advisory Committee. The Native American
Research Centers can also be powerful partners
for engagement strategies. We need to accommodate
individuals who may have limited computer access. And the issue of English
proficiency in some communities must also be taken into account. And we need to stop
talking like geeks, and we have to use more lay
language– everyday language. And I’m guilty of that for sure. Again just continuing
with some of the feedback that we’ve heard, in
terms of the science– and there is some
overlap obviously, but we’re trying to
capture everything– the importance of including
tribally-guided research in this program. Again, we don’t do that. We haven’t reached
our full potential. The recognition of
traditional medicine as a form of precision medicine. The importance of helping
American Indian and Alaska Native communities with
a full understanding of what genomic research is
and how it can potentially link back data to
American Indian and Alaskan Native communities. There needs to be
clarity around funding sources and publications. There needs to be clarity about
the NIH All of Us single IRB. And then finally with regard
to data and biological samples, we have had conversations
with the Indian Health Service regarding RPMS– the electronic
health record access. This is critical for success. We appreciate and understand
that proper handling of biospecimens for American
Indian and Alaska Natives is different than for other groups
and that each tribal nation may have a slightly different view
of how this should be done. So that’s a conversation
that needs to be had. And then of course,
it goes without saying that protection of data,
security, and privacy are absolutely critical. So with that, I hope that
gives you a reasonable overview of the program. And obviously, we welcome
comments, questions, et cetera. What I’d like to
do is to kick-start with a couple of comments. I think it’s on. And I did this this morning,
so you’ve already heard this, but I’m really, really
excited about what the research can represent. And I want to use one quick
example in tribal communities of how sensitive this is in
the rollout– how very careful this needs to be. In my community, several
years ago, we were approached. It was through a
CDC grant, and we were approached to do a
data match with the cancer registry of our population. So we’re the largest tribe
east of the Mississippi. We have 30,000 members
in Michigan alone. And so what they asked us to
do is take the cancer registry data set and do a data match
with our tribal membership. Well, obviously, all
the hackles went up and all of the fear
and all the concern went up at our council
level for that. We don’t have an IRB, so it had
to go directly to our council. And so what the request
was very specifically is to use like a– like Access
to do a unique identifier, which will be your first
name and your last name between the two data sets. And then all it would
do would spit out like a next generation list
that would be in zip code and whether or not there
have been incidents of cancer for that tribal member. And at no point did it have
your name or anything like that. Now, that information– it took
us two years for my council to finally agree to do it
because they were so concerned. But the benefit
of that is now we can do a data sourt for our
tribal members that have cancer and what zip codes. That’s critical information. If there’s issues of
environmental racism that might explain why there
was higher rates of cancer in certain districts, that’s
how you get to that data. And you don’t otherwise
have that data. You don’t have that information. You could maybe say, well, I
have it in my IHS or travel health clinic. I have access to that data. But unless all your tribal
members come to your clinic, you don’t have that data. And so figuring out ways to
get at this data and the value of that data is very important. This morning I used the
example that I grew up in a community that didn’t
have indoor plumbing and so I have H pylori. We didn’t get indoor
plumbing until I was 15. And so H pylori is a condition
in your intestinal tract, or your esophagus like
that, your GI, the lower GI where basically you
can’t metabolize iron. And so my iron levels
are very, very low sometimes unless
I get a treatment. That can be life threatening. At some level that
can be very, very low. So anyway, I got treated– I got diagnosed. I got treated. And it’s like about a three
year treatment sort of thing. And then the other
day I posted it on my Facebook post and
a bunch of my people that I grew up with said,
hey, I have that, too. And how else would we know that? How else would we
have that information if it weren’t for some kind of
way of getting at that data? You know, the different genetics
research– or genetic sources of information, like
23andMe and Ancestry.com, they may be able to give you
some level of information that might tell you certain
health conditions that certain
populations might have. But that is very generic data. This is going to give
us specific data. Specific data to your
respective communities. And once you understand the
marriage of those three factors and it’s environmental, it’s
genetic and it’s– what was the third one? Lifestyle Once you understand
those three, then you’re going to be able to better
understand and do better public health for your
respective tribal communities. So that’s why I’m
really excited about it. And it’s not that
I’m have a bias and I’m going to look away
from any concerns that I have, because I still
have those concerns. But they’re willing to listen
to what we have to say. And so with that, I’m going to
open it up for tribal leaders, chairpersons first,
tribal councils. So we’ll go ahead
and take your input. Raise your hand. You had your hand raised, ma’am. Remember, you got to
keep your hand on it. Or you could use
a hand-held mic, which is somewhere over there. OK. I just wanted to say
a couple of things. [INAUDIBLE] traditional
native council Bethel, Alaska. This may be a level
up, but it goes back to that primer conference
that I attended in San Diego. [INAUDIBLE] There’s secondary and third
tertiary and some biospecimens that have been provided that
the owner of those specimens may not necessarily
have been made aware of or the print was
too small to read. So in this conference, there
was a lot of talk about how bio-piracy, big data, and
recently on the news– I guess tying ends
together to me was the capacity of artificial
intelligence right now. Artificial intelligence
what was the other– computer– tech companies
have professionals that are mining information
about us all the time. Every time you touch a
key on your computer, is being entered somewhere,
these algorithms of who you are and what you do
and how you do it. I’ve been really afraid
like, for example, today. I said this time I’m not going
to sign up for the players club and just go with cash
and see– because there’s a lot of casinos that
have my algorithms right now because I like to
see what kind of benefits I’m going to get from
the players club. So that’s up– to me that’s
a very dangerous thing that already– I can order something
on Amazon and might next see ads on Facebook
show they think that I’m ordering on Amazon. So those kinds of algorithm
and that kind of information that’s already been
collected about me every time I touch my phone. Alexa is listening
to me all the time. It’s scary. It’s scary when I start
thinking about medicine, my personal health, my DNA,
my Native blood that still has secrets yet to behold. Who’s going to have
that information maybe even before I do? So I think that
those are cautions that we need to really, really
take into consideration. There’s no– there’s
nothing governing artificial
intelligence right now. Who’s the boss of
artificial intelligence? So we need to think deeper
about these kinds of things. They scare me. They really scare me
because this kind of stuff can be used against us in
so many different ways. And we’ve been victimized
already because of who we are and how we have survived. So think, think, think,
think really hard. Thank you. Did you have your hand
up, or are you helping us? I’m helping. OK. Other questions or comments? Maybe we should ask if there’s
firewalls to limit access. Your concerns are spot
on really because we are in an interconnected world. There is no question about that. And it’s because of
that very reason, we have created a data
enclave which is cordoned off, which is kept separate, and
cannot be penetrated due to the security efforts that
we are engaged in so that the Googles and the Amazons
and the other groups that you referred to will
not have access. These data will never
be shared with pharma. These data will only
be available to groups that go through those three
different tiers of data access. Now in terms of the algorithms,
the artificial intelligence that you spoke to,
so happens that I sit on a committee within
the United States government that’s looking at how
we should be thinking through the ramifications
of artificial intelligence because it’s real. But here’s– I’m going to
turn it around a little bit. So one of the
biggest shortcomings of using artificial intelligence
for medical diagnostics is the data sets that
are being used to train the algorithms are biased. So there’s this great
algorithm that was developed for cars that are self-driving. And the algorithm was
developed basically using white populations
only, and the bloody cars don’t see any people of color. They had to shut
the program down because it was
trained in a biased– with a biased data set. So if you look at it
from that perspective through participation,
controlled participation, safe participation,
secure participation, you enable the data
sets to not be biased but to be reflective of
the nation as a whole so that whatever
tools are come up with do in fact encompass what
the nation looks like and not just one
group of people only. The secrets of your genetic
background that you referred to, you’re absolutely right. I am sure that there
are secrets there that could be a benefit both
to yourself and your community and beyond. This type of program we feel
can help unlock those secrets, but the only way to do it
is through a partnership. Otherwise, it’s an
exploitation, which is exactly what we’re
trying to avoid. So your comments are very,
very, very important. Thank you. Other questions or input? Mr. Chan. So I have a comment. Yes, please. You have to state your name. My name is Sherry Elie Mendez. I’m with the Pyramid
Lake Paiute tribe, and I’m in tribal
council person. I think with any type
of research project, I think it’s really important– I’ve learned over time
that it’s really important to use a community-based
participatory research approach so that the community
is aware of what the goals of the
research are and then are able to either participate
or not participate. I have some of the same concerns
as this beautiful lady here has and I– I guess– you’re right. Historical trauma
has made us very leery of any type of
research, and although I feel as if the research is necessary
to combat some of the health disparities that Native
American folks are enduring now, I also have a apprehension to
pinpointing those disparities and where they come from
and the genetics of a people who already have
to prove themselves as being Native American. I can’t just say I’m
Native American anymore. I have to have a
blood quantum, and I have to have an affiliation
with a federally recognized– [AUDIO OUT] [INAUDIBLE] So when you take the information and you
find the secrets of a generation of people then the stated use of that is, y’know, we
would all either agree or disagree with that, but the future use of that information is very
critical because we won’t be here forever. And the next guy that comes along that
decides that information is important for defunding health care for Native Americans because
there’s just not evidence that there’s a difference in my blood than anybody else in the room
or anybody else in the country, so I can think there’s a danger in that respect because the use
of the information is going to pass through the government who basically funds our health care,
and holds our land base, and basically, for lack of a better term, controls our sovereign nation. And
so I have a concern about it, I’m curious, I think that it’s important that individualized medication
or medicine happens for people because, I didn’t say that when we look at a group and
use medication formulas that don’t match everybody, you can kill a whole group of people,
and it could have been totally prevented, and I’m living proof of that and I feel as if why
wasn’t I educated on that? Why didn’t I hear that “this medicine ” vs. “that medicine”
can make me healthy again? And when you’re on the brink of those kinds of life changing
moments and then you feel the need to know more that the mass gathering of that
data and how it’s used in the future you probably might think it’s a concern, and everybody
[INAUDIBLE] will know if you have a [INAUDIBLE]. [LAUGHTER] I know. Whatever we do here, one of the very
complicated issues any research with American Indians is a question of who is
American Indian. It’s a very straightforward question, but there’s not an easy answer.
And I’m hoping the consultation process bears out some of that because you have
enrolled several citizens. Some tribal organizations, some tribes have blood quantum
requirements, some tribes don’t. You have inter-tribal blood, [INAUDIBLE] I’m inter-tribal.
I’m descended from three different tribal groups. I also have non-Indian blood, so how
does that factor in? Which genetics are dominant? So also, you have the issue of
Ttribes that have citizens that are, I say dislocated, but not through generations, that have
moved to other communities, like urban areas, that are often completely
ignored by their respective Tribal organizations, which are left out there to fend
for themselves. So, one thing that we haven’t figured out yet, while we’ve got the
sensitivity and the appreciation of how to work through this, is how do we collect whether
they are a tribal citizen, or self-reported? For some reason, and I’m not gonna use any
politician names, I won’t make any jokes, but for some reason people have this warm fuzzy
feeling that about Indians, and some people claim to be Indians, right. But I don’t know
really what the benefit of that is. It wasn’t beneficial to me growing up. But is that like
Affirmative Action funds waiting, or any of that for other racial-ethnic groups, it doesn’t
exist for American Indians. But the whole idea of American Indians being close to nature
and there was a time when Dances with Wolves was really popular because people are infatuated with American Indians, I’ll say it like it is. And so, you
do have a lot of people who will claim to be Indian that could check that box and then your data
is gonna be horribly misoperational. It won’t be correct; it will be spurious results. The issue
of blood quantum or descendency is also very complicated. So, if someone is several
generations removed from the census and not enrolled, not an Indian, but the genetics
say they are, are they to be excluded? And so, I hear your concern and I’m not judging
it at all, about a repository that has our information. I’m old enough to remember The
Red List, hearing my mom talk about The Red List, and people were put on The Red List.
How many remember what The Red List was? The list of American Indians that
were on the watch list. Kind of like the Communist list. And so, any data collection
that has that [INAUDIBLE] represents a threat. It’s only as good as the ethics of the
people who are in government and adhering to the government at that respective period of
time. But, the potential benefit, you have to weigh that out. What are the potential
benefits? One other thing is through [INAUDIBLE]. We had all these concerns, and
we came forward with these concerns— the Child Study—and we were pushing for
them in advocating that they oversample because the way the data was being collected
was just too simplistic and it was small. The main problem was inevitably going to
result in the people who were operationalizing the study didn’t realize that American Indians
are not a homogenous, so we’re not one population, but we’re a nation of nations.
And unfortunately, the administration interpreted that as they didn’t want us included
in the study. We wanted it to be done properly. What happened was they
dropped us, we were dropped from it. So, we have to figure out
how to give our concerns so that they address our concerns, but seeing]
utility of the results, potentially [INAUDIBLE]. I’m sorry to interrupt. I just want a quick
clarification from the audience to make sure everybody is able to give input. So, I just want
to make sure I am clear. So, people are being recruited now, they’re being recruited
at big medical centers, they’re being potentially recruited at CVS’s and Walgreens
and that kind of stuff. They’re randomly recruited around the country in different
areas with partners that happen to be there. You don’t have anybody recruiting on tribal
lands, but you hope to, hopefully, if that might work out. But still American Indians last
names are being recruited right now just not purposefully, but just incidentally, if they walk
up to this place. And then once they get recruited, they sign a consent form
that’s essentially broad consent. Not only are they saying you
can take my blood and my survey data and all that,
but people will be able to use that if they– lots of researchers
and the public could use all that, depending
on the level of protection, in the future. So the person walking in
to do this medical therapy agreed, signed a broad
consent, potentially hundreds or thousands
of researchers could use that
data at some point as long as they got it reviewed
by your board and all of that. But currently
there’s not anybody who’s triangle on those boards. And even though you’re saying
that public information and the non-identifiable
data set won’t have names
or ages anything. Genetic material’s
identifiable and in ways that might be too graphic or
in ways that might be close to the ancestral
[INAUDIBLE] or whatever so that it still identifiable. So one of the issues that I
think I’ve heard from tribes is once that person
gives their blood and gives their survey
information and– [AUDIO OUT] [INAUDIBLE] I’ve been hearing a lot
of this complication consultation that, I
maybe have [INAUDIBLE] With this so-called research. Just a couple of months ago,
I went to the USCA and– that’s the United States
Conference on AIDS. I went over there. I’ve been there
for a whole week, National Indian Health Board
sponsored me to go out there. And it was just surprising
to see all of the statistics and percentages– Anglo, white, African
American, Hispanic and Latinos, and then what about the Native
Americans, Alaskan natives? Where did they go? Where did they– where
is the percentages? And the question for me to
ask you is what are we going– what are the disadvantage
going to be again for us. As a tribal leader, for
me, I’m very disappointed. Not to [INAUDIBLE]
at a national level than to be in the midst of 3,000
to 4,000 people non-Native, we were only about 65, and
I was the only a councilman at that conference. And I’m just like you’re
saying there are research we’re gonna do this research again. And then just a couple of weeks
ago with the tribal leaders meeting again, there
was a hospital up in Salt Lake or
some area wanting to do some kind of
cancer research as well. And the same thing goes again. Are we just guinea pigs
for other national people or national– I would say other Americans. Are they just using Native
Americans as guinea pigs? That’s the way I think about it. Are they trying to just like
what the elderly was saying, we need to be careful with what
we do and how we go about this. And that’s the reason why
I try to say let’s go back into and look into and
ask our eldery what to do and how to go about this. And what my question
would be is how are these researchers
going to be helping us? Because I haven’t– at least
for two years right now, I just didn’t hear any
complications, research that, research this. But I haven’t seen
the progression of it. Progress has this whole process. So I– for me, I would– on a positive
note, I would say I would like to see this
but in a positive way rather than having
our elderly say, oh, they’re just putting us out. Just like the elderly [INTERPOSING VOICES] Whether you’re
ordering something, you already know
that your name’s going to pop up somewhere. That’s the way I look
at it now as well. So that’s why I’m saying
if you guys are going to do research, help us out. Help the Tribal Nations out. Rather than just
helping yourself out. [WHISPERING] Help the Tribal Nations, help the
elderly, help the youth groups, to know what you’re trying to do. What do you want it to do? Are you– I’m into
are you wanting to go into the health
bill or get it repealed. Help them as well
only just yourself [INAUDIBLE] All I need is all I want. [INAUDIBLE] Consultation. And then going back into
this consultation letter, I would recommend not
as your tribal leader. To me, I’ve set aside so
many of your tribal leaders. There is going to be– with our tribe,
there’s seven of us in our tribe, seven
tribal leaders– president, vice president,
and five tribal council. So our thought is are the
leaders, any one of us can be tribal leaders. So if there’s a “dear
councilman [INAUDIBLE],”,” then I would open it. Oh, this is very important. But if it’s a “dear
tribal council leader,” I’ll just put it
off to the side. So I would strongly recommend
use of put the name in there rather than a “dear
tribal leader.” For me, from my perspective,
that’s how we look at it. Just now I just got a “dear
tribal councilman [INAUDIBLE]”” letter from one of the National
Recreation Areas, and that’s– I would open it up and read it. I did. They had to respond to
it right ASAP, right now. That’s one of the things
that for me, my perspective, I would recommend that. So something for you guys
to think about as well. All of these different tribes,
they’ve had their websites up. They have their chairwoman,
their chair members, their tribal council. Their names and addresses. One that came in here
that I don’t understand, and I don’t mean it
to sound partisan, is just– a quick question. But what about the
Trump administration trying to lift the
ban on gene patenting? And I don’t even know
what that is so– [INTERPOSING VOICES] Because I’m hearing
it fine, so it could be this one person
that’s talking into it– I’m sorry– the person
that’s on the phone. We have a session this morning
where they explained it. And so basically [INAUDIBLE] It’s not eligible for patenting if it’s
something that is naturally occurring. If there’s something unique
about it or some methodology or some product
as a result of it, that potentially
could be patented. Otherwise, it’s like
the public domain. With regard to sending a Dear
John letter to the tribes, Well my name’s not John. There is no warehouse of
that information anywhere. And I know that NPI tries
to keep up a list that is immediately obsolete. Elections happen all the time. People turn over all the time. The BIA has a list that is
horribly outdated as well. So I know what you’re saying
because we get inundated and we actually fought
for consultation. We get consulted now and I– tell you the truth,
I can’t keep up on all the times
I get consultation in the classifieds. But understanding that, some
more affirmative recruitment and trying to get
that information from respective
tribes is something that we have to
figure out how to do. So first of all, there is
no disrespect by sending a [INAUDIBLE] It’s not a good excuse but
it’s just a practicality. But there really
is no disrespect. I think you said
very clearly why research programs conducted
thus far have fallen very short. The reason this program
is seeking to the term uses over sample as
diverse a group as possible is so that we are inclusive
of all peoples in the nation. The reason that we
want not only to know what specific questions tribal
communities want studied, but also to include tribal
members who are actually doing the research is
for the very reasons that you articulate. So my– let me– my bias is going to show now. I want to get every young
kid excited about science. I don’t care where they’re from. I don’t care where they live. I want to get them
excited about science because I can think of
nothing more exciting. A really good way of
doing that is having research conducted
by people just like them in their communities. That’s how you get
them excited about it, and that’s the, if you will,
entree into other things. That’s the type of thing that we
hope to be able to enable here. But you’re right. The track record’s
not so great, and we have to acknowledge that. We’ve got to do
something about it. And the only way we can
do something about it is with your help. With the elected
help of the group. So thank you for your comments. Over here then over
here and then here. There’s been absence [INAUDIBLE] Hi, Travis Lane with
Intertribal Council of Arizona. I have a question. So with all of this project,
is the research restricted only to precision medicine
from research projects? We are using that
as a tagline if you will, as a summary statement
of the types of things that we’re doing because
we feel that by learning, one contributes both to health
and resiliency against disease as well as disease
itself, that that will lead to precision intervention. So somebody could
just look at my blood and not necessarily my
lifestyle or environment? I would be– yeah,
they could in theory although I think with big data,
which was mentioned earlier, I suspect that
most investigations will try and look at all of the
parameters at the same time. But, yes, it’s possible. So what might be helpful– because I’ve never– I’m not a health
researcher or anything, but I’ve never seen any
peer-reviewed articles about the benefits of
precision medicine, how it helps communities,
what that looks like, how they use that to– how they even use lifestyle
environment and genetics to improve someone’s
health, and treatment. I’ve never seen an
article like that, and that might be helpful
to share on your websites and things like that. Certainly we could
do that because there are examples of that. I can give you personal
examples, but I– yes, there are examples. Yes, ma’am. Don’t forget to say who you are. Hi, I’m Gwynne Evans-Lomayesva
I’m with the NCAI Policy Research Center. And my question is
similar to this. So I’m reading a
sample of the consent, and I know that in
broad consent things, you need to have some the scope
of work of all research that falls under it. And from what I’m
seeing on this, I don’t know what
the scope of research is, so I don’t know the
breadth of research that falls under this. All it says is lots of studies. So I was hoping you can
elaborate a little more on this. So I need a little help. What exactly– do you want to
know the types of studies that we’ll– Yeah, I’d like to know–
so I know that you haven’t a single IRB, and that has
to review all of the research proposals moving forward
with the secondary research. And I don’t know
what kind of studies necessarily fall
under this for the– what will be
reviewed or accepted by the single IRB for this. So can you elaborate on
what the scope of work is that any kind of
research will fall under? So again a lot– much of it we don’t know
yet because researchers will need to propose
the questions that they want to answer. What is being created
here is a platform upon which research
studies can be enabled. There are no specific
here’s study 1, here’s study 2, here’s study
3 yet articulated. What we’re creating is
a resource platform. So unlike many of
the other studies that I’m sure you’re very
familiar with where you’ve got a very detailed protocol
and everything is laid out in advance, we’re not there yet. We are just building
an infrastructure so that you have a cohort
of individuals who have pre-consented for basic things. The specific studies may
require additional consent. When I’m looking at
you, I’m guessing– go ahead. [INAUDIBLE] Yeah, please. That’s why I’m waiting for you. Which part of that– You had to keep your hand on it. OK. So just to clarify, the
single IRB that we use is for what we do with the
research resource itself. So someone who is planning
to do research, for example, at the university, their IRB
will bring you that study. It’s not the IRB
that we have that is really just about
the platform that’s Dr. Tabak described. So I did want to clarify that. The research access board
that Dr. Tabak described is the board that is
responsible for defining some of the parameters
around what we expect will be thousands
of studies that will use very big data sets. So it’s a little bit
of a different process. Again, we’re not the study. We are the foundation upon which
folks will come in and conduct the research. Yeah, I was asking more
can you talk about what those parameters are? So again that’s hard to
describe because we anticipate that we may have social
scientists that come in to use the research
resource, epidemiologists, basic scientists, people
all in between, so we really hope and believe that
the recent research will provide a foundation
of data for very broad kinds of research. So we can’t really design
point by point what studies will be done in it. Again it is because
of the diverse data that we’re collecting,
we expect that people from many different
disciplines of science– again hard science,
soft science– will all be able to find
a home in the database from which they can conduct
great research to advance health. Of course, she didn’t
mean soft science. My kids are social
psychologists, so I have to defend them. In other words, unlike
the traditional study that you and others are familiar
with where you enroll a cohort, you do the study,
the cohort disbands, and then when you
do the next study, you start all over again. What this is doing
is just creating this very large,
very diverse cohort, which will remain in perpetuity
so that as researchers come up with great ideas of
particular studies, they can access not necessarily
everybody in the study but subsets of
people in this study in order to perform the
research question that they’re interested in. It’s a little different than the
typical and frankly NIH-funded study that you’re interested in. So maybe what we’re asking for– maybe what we’re asking
for is for our population to have some safeguards on
the use of data that would perpetuate, that would
continue into the future and how that data could be used. And so I have to say it. So during one of
our stack meetings, Dr. Collins was very excited
to roll this out to us. And being somebody who has
watched different research that has exploited American
Indians, I raised my hand and I said so how will we
protect against somebody concluding that Indians
are genetically inferior or just there’s no hope or just
let them die sort of thing. And he was really
shocked by that question. And some people I guess are too
brilliant for their own good, and maybe he’s never thought
of that question before. He’s never had to. He’s not from the same
demographic that I am. And so maybe this input could
incorporate our concerns across Indian Country
that any kind of data– future use of the data
that articulated– protect and carry
our concerns with it so that the results
of that can’t oversimplify and really in a
way stereotype American Indians. That’s a very real concern. Yeah, please. I think these
questions are really critical ones for tribes. So now I’m not even clear on
the consent process because– so people have to have a consent
process when they sign up at the health center or
Walgreens or whatever. That consent has to
be broad consent. And broad consent
under the common rule requires that you have a
clear scope of work of how that data is going to be used. And so that’s a question
that Gwen was asking. But now when Gwen says– that Gwen– that once the
data’s in the database and the researcher
applies to use it, you’re now saying all of their
IRBs at their universities are going to be involved, which
all of a sudden exponentially increases the risk
for the tribes because we can’t trust the
IRBs at many universities in the country. And so do I have a wrong
understanding of this or– because if it was
just so all of us had a single IRB that was
reviewing and making sure that the researchers
were doing good research, that’s be one thing. But if you’re also invoking all
the university IRBs, the IHS IRB, and everything,
then you’re going to have to invoke the tribal
IRBs somewhere in that process to ensure that– and universities don’t
always talk to the tribes. And so I’m suddenly– and
we’ve written a brief on this. I studied it, and now I don’t
even know what the process is. So can you guys explain? Because it’s really
critical for tribes to understand the stages
of where tribes can ensure they are protecting
their citizens. And if there’s multiple
IRBs involved in that, that’s more concerning I think. So I don’t know. Help me. Thank you. Well, that’s part
of why we’re here is to get great advice
on how to proceed. So the resource access
board that we’ve established and which thankfully
as of this week has a really wonderful
AIAN representative on it. We’re super happy. We’re ready to
start work on that. It’s going to be defining the
policies and the trainings that we among the things
that we can control are the policies about the
kinds of research that we’re putting out there that are
allowable within the database. The consequences of not
following those policies, again– they’re policies. People can be bad
actors, but we have to live in hope that people are
good actors most of the time. So the research
access report is going to be defining
those for the study and is going to be
responsible for keeping an eye on the research. We require– this is one– one of the required–
even though we don’t have a lot of the
policies fully baked right now, one that we do have baked is
the requirement that researchers when they want to
propose a study, they have to publicly
post what that study is using the database. So it’s not only us, the NIH and
the All of Us Research Program and our resource
access board that can monitor the work
that’s being done, but anyone else can as well. The research access
board is not an IRB. It’s not a single IRB. So then all it’s
doing is regulating who can access the data
so that IRB approvals are up to whatever the
researcher is governed by. That is correct. That’s interesting. So the challenge is normally
if a researcher wanted to do research with a tribe and
the university was involved, the university and tribal IRB
approval or council approval or research review
board would be required. But since this is a
national data set, the university
researcher comes to you and says I want to
do this research and I also want to look at
some American Indian stuff, how does the tribe get involved
in this review process? That’s what I’m now
am very unclear about. Again, just to depart,
this is what we’re here to try to get feedback
on so that we can come up with great processes that
do get tribes involved. Are you open to suggestions–
are you open to suggestions? We– want suggestions. So when I did my
dissertation research, I used the data set
at a university, so I had to get an
IRB approval there. I had to get IRB approval
at my host institution that was giving me the degree. Well, not giving me. I earned it. So there was two levels. And so what my tribe
does because we don’t have an IRB is if a
student comes in, first of all, we won’t entertain it at all
unless they have a university IRB approval first of all. Then we articulate additionally
on top of that including intellectual property
protection for the data that’s– mostly to ensure that
they don’t desegregate, that they don’t
use any identifiers where somebody could figure
out what community was studied. And so I guess I would
recommend and this might be a big ask is that
any research that might categoricalize– that’s not a word– research to
particular population should probably
include an IRB approval from that respective tribe. And if that tribe
doesn’t have an IRB, sometimes there’s
coalitions of IRBs tribes or for consent from
that respective tribe however that tribe defines that. And I know this
is getting very– it’s getting very hairy
because it would be easier to just give up on the
Indian population given how complicated
this is going to be. Also we have the
issue of small n. And so I will tell you
from A Track and from NIH that tribal leaders that
have worked in this area are very dissatisfied with
research– national research or university research
that relegates us to other. So we can’t talk out of
both sides of our mouths and say we want over sampling,
that we want to be included. We want to have the benefit
of public health research. But on the other hand, I don’t
believe we’re saying that. I think what we’re saying
is that given our track record with the federal
government, with universities, with the unethical approach of
research in Indian country– research on Indians
that our concerns need to be incorporated. So wherever possible for
a respective tribal nation to have to weigh in on consent
and the use of the data. So now we’re talking
two different things because one is
collection of data. One is the use of the data
after the data is collected. And so this is very
complicated because I still think that there needs to
be some level of consent from a tribal perspective– a
tribal sovereignty perspective of the data that is collected. So once we are up and
rolling, something that’s going to happen
is that the data that is collected– the other
thing is verification of that whether or not that
person is even an Indian. And so I don’t know
how do we get to that. I think there’s ways to do it. We could articulate how we can
figure out how to get to that. But otherwise, you’re
going to have– you’re potentially going to
have a lot of people who are claiming to be– I would say that of the groups
that have volunteered already, there’s probably
a big percentage of those people who
aren’t even Indian at all. And so the only way that you can
get to that is through a tribe because there isn’t a– I know the BIA tries to
collect your membership list, and we say no to
them all the time. Nope. You can have our
zip codes, but you can have our list because
that’s a matter of sovereignty. So all of those things
have to be figured out and operationalized. So let me try and unpack
this a little bit. So we’re pretty tenacious. We’re not going to
give up just yet. But I guess what I
hope we are able to do is we’re able to reach an
agreement to have discussions by tribal nation because you
do it with one tribal nation, it’s not going to be the same
for another tribal nation. But let’s say that a
particular tribal nation agrees to have an in-depth
conversation with us and we come up with
an approach that is consistent with values,
community norms, et cetera. So now people from that
tribal nation can enroll, and then to reach
through, now what are we going to use the data for? Does it now go– and I think
that’s part of the discussion. Now you’ve got to go back
to the IRB if there is one. You indicated in your
particular nation has no IRB but you have other ways
of dealing with this. And is it a little
more complicated? Yes. But that’s how
we’re going to get a data set that’s representative
of the whole nation. Because absent that, what
we don’t want to see happen is people just
throwing their hands up and saying too complicated. And we’ll just–
that’s not the answer. But we appreciate that–
in other words, what we’re looking for here
is the general framework. And we’re getting a lot of
very important feedback, and frankly we’ve heard
some things here today that we’ve not heard before. So really been
extremely valuable. We get a general framework,
but then we’ve got to take that general framework– and I didn’t
even have to operationalize it– with those tribal nations
that raise their hands and say, yes, we would
be interested in having additional in-depth
conversations. And the hope is that many–
some ultimately can come to an agreement that is mutually
appropriate and thereby being inclusive but also be cognizant
of the need for protection and not just now but in the
future because that’s come across loud and clear, the
concern about you folks may be nice, but what about the next
group and the group after that and the group– and that’s real. I do appreciate that. But I do think that
there is opportunity to work through this. And I suspect that if we– I’m making this up. So let’s say we come
up with six different– I’m making it– I suspect that all six
will have similarity, but there will also be some
differences, some nuances. I don’t think that’s a
bad thing because again I think participation– some participation is better
than no participation. So I think some of you know
that NIH entered into a– an agreement with the
Navajo Nation on data sharing for the Echo cohort. And that– it took time, and
it was a lot of discussion. And Dave– Dr. Dave
Wilson here obviously was very involved
with a lot of that. But we do now have an agreement. Now can that agreement be
ported new your nation? Maybe elements of it can be. I don’t feel– I don’t know
but maybe as a starting point. But we– there we have an
agreement, different study, not all of us, different study. And that’s how I think
we can approach this because if we don’t
do that, then we’ve got this dilemma, which
you said very poignantly. Where are the American
Indian and– where are the American Indians? I don’t see them. They’re not being represented. But we will all need to help
us get there, and we can’t– because clearly we’re not
going to be able to figure this out ourselves. We’re going to go
to Abigail, then I have a housekeeping then we’ll
go back to taking questions. So thank you, everybody. My name is Abigail Echo Hawk. I am the chief research
after Seattle Indian Health Board, the director of the
Urban Indian Health Institute, and I was– and I am on the tribal advisory
committee for All of Us. And I just want to make very
clear that these comments are coming as from my
organizations, not as a member of the advisory committee. I just want to start
actually by saying thank you to Dr. Dave Wilson’s office. I would say in the
past couple of years that it has been a
complete shift in how we’re working with
tribal nations and ensuring good feedback. I would encourage you to
further fund his office because we need more of that. We are seeing some
integral things happen, and I’ve worked time 28
NIH-funded studies across 14 institutes in the past years. And we’re really seeing
a shift and change that is coming from that office, so I
want to say thank you publicly. I have some comments and going
to go through the slides. I took notes as you
went through the slides. But first I want to start by
recentering us and thinking about that we are
doing and thinking culturally rigorous research. And so I know I
come from thousands of years of researchers,
and, in fact, the Pawnee people were
the first geneticists. We genetically modified
our corn to get it to the different species
that we currently have today. And I think I’m one of my
uncles, my Uncle Fred John, from [INAUDIBLE]
Alaska, and he always used to tell us the story. He would take us
out to this lake, and we would count the number
of beavers that were there in the spring so we knew how
many to hunt during the winter so that the people were
both fed and had food but so that there’d be beavers
again there the next spring. So we gathered data. We evaluate it. We did it at rigorously multiple
different times for one reason only and that was for the
good and the well-being of our people
because we love them and because we care about them. And that’s where culturally
rigorous research is started from, and so when we
have these conversations, it needs to be acknowledging
that indigenous peoples are science. And this isn’t an outside– just an outside initiative. This is part of
who we are, and we are reclaiming that
through processes like these consultations and
listening sessions and ensuring that we are equal partners as
these types of initiatives move forward. So you’re presenting to
a bunch of scientists who are carrying that
and have carried that within their blood, which
we’re talking about blood, and that blood memory
that comes with it called genes or genetics. They’re epigenetics as
those beings have shifted, but it is something that we have
always been and will always be. So in thinking about that, I
actually worked on a project with Dr. Spiro Manson
about three years ago, and there is a series
of videos– two videos with the American Association
of Medical Colleges that sat down and talked with
urban Indian populations very specifically about their
thoughts on precision medicine. I would suggest everybody
take a look at those videos and also those at the NIH
to really see and hear multiple perspectives on where
and how people are thinking about precision medicine. And as we go into the slide,
you had the principles of data access up there. And I think one of the things
from my perspective in working on this for quite
a while is what’s missing is unintended
consequences, not thinking about what might
be stigmatizing when you start monitoring throughout that
but what is going to happen is they’re absolutely going
to be unintended consequences from the equity framework
that was just presented in are we actually going to have
these discoveries ending up in our communities. Are you going to be building
medical discovery for the elite based on the backs of Indians. And so it’s really
looking at what are those unintended
consequences and having an eye on that
from the very beginning. Tribal representative
on the acts on all of those
boards and I know that that was one of the
recommendations that came out of the advisory committee. We need that now because
one of the things that Dr. Rubido and her staff
were talking about is what kind of studies
are going through. What are the things
that are happening? If we can get
representatives on those now, that is integral, again, as we
begin to build and understand what is going on, and we’ll
still be able to bring those– that feedback back
to these groups, back to their tribal leaders. And I would also
suggest when we talk about those who
sit on those boards that you use your
tribal affiliations. American Indian
and Alaska Native is talking about big groups. When you’re talking about one
person, I’m a Pawnee woman, and that’s who I am. I’m not American Indian. I’m a Pawnee woman, and
with that comes the stories and the responsibilities. So whenever possible,
use people’s tribal affiliations
just out of respect for their tribal communities. And the other thing in the
principle of data access that is integral is looking at
the tenants of indigenous data sovereignty. I do sit in on the US Indigenous
Data Sovereignty Board, and we look at indigenous
data sovereignty and the fact that as in a government to
government relationship, any data that is gathered about
us needs to be governed by us. It needs to be interpreted
in partnership with us. And so indigenous
data sovereignty is something that has
to be paid attention to in becoming part of thinking
about how that access is given. And then when we’re talking
about the data access, who are you defining as researchers. I think of my grandma Katy
John from [INAUDIBLE].. She never graduated high
school, and she was probably the best scientist I’ve
ever met in my life. I was just telling
this incredible woman that my son got stung
by a bee in Alaska, and I reached over to a tree
and I chewed up some leaves and I put it on my son’s arm and
I didn’t even think about it. I just did it because that was
the way that I had been taught. And she had passed
that knowledge down. And so when we think
about researchers and we look at how the RFAs
that come out the way that NIH places those and even as you
put these good barriers in place to ensure that data’s
accessed appropriately, you have to think about who
you’re defining as a researcher and so that it doesn’t become
an elitist group that’s doing that because we know
that there is absolutely underrepresentation of
American Indian and Alaska Native scientists and PhDs and
those that are actually funded through the NIH to receive
and to be the principle investigators on this project. We can’t always be
the research staff. We need to be the principle
investigators and so really thinking about how and that
is defined as you think about who are the researchers. And also in that data access,
it needs to include tribe. It needs to include tribal
colleges and universities. And it needs to include tribal
epidemiology centers, which I do direct one. It can’t just be
academic institutions. And very often when
those designations do go up that we’re not
included in that. I think about the
Chickasaw Nation. They are completely
capable of doing anything the University of
Washington would want to do in terms of
their IRB and the brilliance of the people that they
have there and the academics that they have within
their organization. So we need to ensure
that when we’re defining who the researchers
are saying that it isn’t an elitist Western
concept model, but it really recognizes– and
I think that this is something that other communities
of color are also going to be very interested
in and fighting for when we think about this initiative. When you’re defining American
Indians and Alaska Natives and you go through the–
sort through the data, American Indian, Alaska
Natives, and Pacific Islanders are some of the largest
growing multiracial groups in the country. So it’s really
imperative to ensure that people are able to check
individually racial categories and that when the
researchers go in to look at those
racial categories that they can just
aggregate that, that it doesn’t come up in one
multiracial category or one of the things we see very
frequently if you were to collect both Hispanic and
Latino and American Indian, that Hispanic and Latino is
the only one that actually shows up. And they don’t count them
as American Indian or Alaska Native. And so that is one
area again in sharing in those multiracial
categories that it’s able to be sorted in that way. In the slide you had on
elements for creating success, you had urban Indians do
not require tribal approval to recruit. The characterisation
of that, I wouldn’t say that your element of
success is the fact you don’t have to get tribal approvals. And so what I believe with the
travel advisory committee one of the feedback that I
brought to them was is– my greatest fear in having
worked in genetics and genomics for many years– is that when they look at all
the perceived barriers and it’s things that take a long time
to go through tribes, then instead they’re going to show
up in my office and say, hey, can we just recruit from
your clinic population. I have 45 American
Indian, Alaska Native people that are part of
my clinic population, and they expect not to have to
go through tribal approvals. And so we have to watch and
be very cognizant of the fact that our urban Indian
populations are not being preyed upon
through this initiative because when we look at
these large research centers and where they’re
at is that they are in large urban settings with
these really great universities that are gathering
this information. We cannot let it become a
predatory process as to where they’re only recruiting from
urban Indian populations to specifically avoid going
through tribal approvals. And I do say specifically. I’ve been doing
this a long time, and I have seen people do it. And we have had to
push back really hard against those
investigators who come on with the purpose
of completely avoiding tribal approval if
at all possible. That is a way for them to try to
circumvent tribal sovereignty, and it also doesn’t recognize
that under Indigenous native sovereignty, I am an
enrolled citizen of the Pawnee Nation of Oklahoma federal
trust responsibility and the ability
of my government. I have one president. His name is Bruce Pratt. He– I am a citizen of
their nation regardless of whether I’m on the confines
of the Pawnee reservation in Oklahoma. That still applies to me
in Seattle, Washington. So you have to be careful
with that in particular, and I think the
wording of that slide is off because it’s not
a element for success that you don’t have to
get the tribal approvals. It is a cautionary– you need to work with the
urban Indian organizations and for example when
we talk about when we’re defining who is Indian. The reason there’s
a lot of interest in the urban Indian programs
that are funded by the Indian Health Service is that
we do verify enrollment or descendency as
defined by IHS in order to capture the
reimbursements that we do. And so that we do have
a wealth of information and we have these
incredible people who access our services that
we have a responsibility to care for, and that
includes making sure that research projects are
not preying upon them simply because they don’t live in the
confines of their reservation. The other aspect that hasn’t
been talked about a lot is the economic impact. And so when we think about
precision medicine and just medicine– medical
discovery, whether it be a new social behavioral
intervention, whether it be a medical device,
whether it be whatever it is, that there is money
that’s made out of it. This is called the research
enterprise for a reason. There’s a lot of funding
that comes to it, a lot of funding that goes
to the NIH and to others. And very rarely do we actually
see those funds get back to our communities. But we are the most popular
to include in an NIH study because people want
to research about Indians. The thing is we’ve been
researched to death, but we have seen very
little benefit of that and particularly when we look
at the economic impact of that. And so I know that’s
going to be concerned of our tribal
leadership is how is that economic impact
actually going to reach their tribal citizens. And I mean that
economic impact also in the studies that are funded. Again, we’re building
socioeconomic and academic prestige and economic impact. Again, when we look at where the
funding goes to from the NIH, it is not to
communities of color nor is it to principal
investigators of color. So how is there an effort
to mentor to bring up– I currently mentor
15 from undergraduate to post doctoral and
medical students right now. I don’t get any money for that. We just do it because
it’s a necessary part of caring for those
next generations because I want them to be
the ones who are doing that. And instead what we see
with these kinds of efforts is again the prestige
of and the what is the seed of the
knowledge holders tends to be people outside
of our communities. So how do we begin to
engage in conversations that looks at economic impact
and multitude of levels from the money being able
to flow into the tribes by ensuring that we
are both understanding that tribal colleges and
universities, tribes, urban Indian organizations,
and Indigenous research organizations like my own
tribal epidemiology centers have the ability to conduct
these kinds of studies and should be part
of these processes. And that’s also looking
at dissemination and the implementation and
how those plans are made up. I was at that same conference,
the HIV conference, for USCA and he’s– the tribal
leader is absolutely correct. Not a single slide it said
statistically insignificant. My feedback to them on that
is that when we are not an inclusive American Indian and
Alaska Native populations that particularly within the
data and the research and if we are not doing all of
the things I’ve talked about and what is talked
about here at this table is that it’s an
active participation, the genocide of our
people by eliminating us through the data. And also we have to look and
think about how and why that is happening. And when we think about
the small in which is a small sample
sizes, my team are experts in doing small
sample size calculations. That’s what we are
experts in, which is why it makes us key
to ensuring that when these studies are done
that organizations like tribal epidemiology
centers are brought in to ensure that that doesn’t
happen and we’re not eliminated through the data. And, again, it needs to have
a continuous equity lens. How is the discovery of
medical devices, whatever it is, actually going to
benefit the communities of color because historically
that hasn’t happened. We just have to look at
the hep C medications. How long did that actually take
to reach Indian Country when all of these middle class and
upper class white people who were getting access to and
had access to the hepatitis C medications before
it actually reached marginalized populations,
particularly American Indians and Alaska Natives. How long did that take? Those gaps are
unacceptable, and so we have to be thinking about
and requiring those principle investigators to be
thinking about that so soon. My elder over here, she talked
about some of the secrets that our blood holds. Some of the secrets aren’t
meant for anybody else to know. I think about my tribe, the
Kitkehahki Band we have songs, we have dances, we
have things that are just meant for our
community, and that’s OK. And so it’s really taking
the tribe’s leadership on what is appropriate
for their tribal community and what may not be
appropriate for others, and that is going to vary,
which is why these consultations are so important because
some secrets are just meant to be a secret. And I do believe in
precision medicine– I’ll just finish one story. I’m sorry it went so long. I made a lot of notes– is that I started
in this by doing– I’ve been doing
biospecimen working with and interviewed more than 300
American Indians and Alaska Native people from more
than 250 different tribes, so it was a lot of
different tribes obviously. And I met this one woman and she
had done– she did our survey and I did the interview with
her, and she started to cry. And I asked her I
said are you OK. And she said I didn’t
know about this. She was talking about
biospecimen collection for cancer specifically. She said– and she told
me– she said my mother and then her and
then her daughter– so a grandmother, a mother,
and a granddaughter all had breast cancer at
the exact same time. And she said if I had known– if somebody had asked me
to donate a biospecimen, if I would have thought it
would have helped my family or helped my tribal community,
I would have given that. And so she was in one of– she was being treated at the
Fred Hutchinson Research Center Hospital in Seattle,
Washington, one of the most prestigious
cancer research centers in the country. There’s also a perception
that we don’t participate, and so people don’t ask us. And so I think the
kinds of things– and one of the results of
this All of Us Initiative is going to be broader
than just the collection of the biospecimens
but really thinking about the overall impact that
can happen when we actively participate in
research processes that have to be respectful
of tribal sovereignty. If they don’t start
there, then they’re not going to be successful. But when they do,
I think of that as that mother
crying and telling me she would have done that. I wish she could
have, and I hope that for all of our people. And what I love about
precision medicine is I know I may not see some of the
impacts of it in my lifetime, but my kids might and
my grandchildren might, a sing song for my
children’s children. And I think that’s what
precision medicine really does fit within the
Indigenous concepts that we have as Native people
in looking forward to those next generations. And so in looking
forward, we have to also appreciate what
happened in the past and looking at the historical
mistrust of research in order for us to move forward
for the future generations. That was an amazing
primer on this overall, and I appreciate that. It does remind me to ask the
question for consultation so some people are really good
at articulating it on the spot. Some people need a
little bit more time to synthesize it and
bring it together, give people that
are on the call, and there will be additional
consultation sessions. And if we could go back
to that slide maybe, the dates and those consultation
sessions so we can help get the word out. But my question is somebody
here is recording everything, and all of that will be
distilled into our comments. Will that be posted
so we can see that and to make sure that
it’s reflective of what we had to say. And then also do can– do we
have a time period by which we can submit formalized
comments that we didn’t craft today and submit those? So the short answer is yes. The synthesis will be posted,
but what about the time frame? So we would love to start
getting a report together and really synthesizing
feedback soon after the August 21st consultation. So we haven’t put any
hard deadline on it, but if we could get feedback by
August 28th, that would give us a lot of time to– we’re already now starting to
really get a database together of feedback that we’ve
got everything organized and we are ready to go. But we would love it– we’d love to have some– a final report by the end
of September if possible. So for the benefit
of the people who were in the room and the
people who are listening, they could have up until
the 23rd of August to able to submit any of their
consultation comments from this consultation. We could make it even. We could say August 30th. We could say through
the end of August. OK, good. We appreciate that. Can I give a plug for ways
to submit information. So if you go to our website,
we have a cell phone where people can call or text. We have a 1-800 number
where people can call in. We have an email address if
people want to submit feedback by email, and we have
our snail mail address, so we’re trying to put
out every modality. There’s also lists
where people can sign up for to get additional
information as we add listening session, for example. Don’t forget your evaluation. I’m not wrapping up or
anything although it might be wrapping up. But don’t forget
your evaluation form. That’s helpful to know. I also want to call your
attention to vacancies– and I’m looking
over at Abigail– vacancies on the
NIH travel advisory. As you can see where
those vacancies are, we do have an at large
vacancy open right now. And if you can encourage
tribal leaders, we’ve had some
pretty good success in the last couple of
years with advising NIH on how to move
forward with respect to their engagement in
the Indian community. And so we want to keep
that ball moving and we– I’d like to recruit. So if you know of the tribal
leaders that have an interest, they don’t have
to be scientists. We have people on our
group that are not PhDs, people who are
practitioners that have a nominal firsthand
knowledge so please help to get the word out. So I’ll keep the ball rolling. Other comments from the group? Well, we had one online,
but I think we answered it. So it was just to remind us that
Canada, Brazil, Mexico, India, China still allow
gene hackenings– hackening if I’m saying right– how is that data going to be
protected internationally? That makes sense? Yes. And I think it’s the same way
it’s protected domestically. The data can’t
leave the enclave, and so it will not be
sold or distributed to anybody outside
of the enclave. And so I think
that’s the answer. I know people are concerned
about piracy, literally piracy– information piracy. But none of this data
can be downloaded. I just don’t want the Russians
to have access to my data. I don’t know why
they would want it, but they perhaps already do. Yes. Other comments? We don’t have to go to the whole
time if it’s not necessary. So then I will hand
it over to Dave. Dave’s going to do some
summary comments for us. Do I have that right? It says it right here, right? Dr. Tabak is doing that. I’m happy to defer
to Dave since we’ve learned what a great job
you’re doing, so go ahead. [INTERPOSING VOICES] I wrote down to– actually, we’re doing
a double budget. Suppose that we
double his budget. [INAUDIBLE] I’ll just say a
couple of things. Really just to thank everybody. This has been an
extraordinarily rich session. I learned a lot. I really did. And so I really
thank you personally. We are in this
for the long haul. And so please do submit
additional comments as you are able to
formulate them and stay tuned to watch as this unfolds. But on behalf of NIH and the
All of Us program in particular, thank you all for being here. But, Dave, if you’d like
to have the last word. Great. Thank you, Dr. Tabak. I did want to say that I think
that one of the challenging components of the All
of Us Research Program is that they are taking on
a lot of topics that are far in advance of what our–
the THRO office has been able to address. We are beginning to address
the very difficult questions around biosamples, around
data sharing and data management in coordination with
our Office of Science policy. But the All of Us
Research Program has identified this need,
and they are moving ahead and I think that’s what the
challenging part about it is in we’re trying to catch up. And I think that there’s going
to be some things that we don’t capture, but as Dr.
Tabak said, this is going to go through
continual refinement. So even though we may
get tribal nations early on that want
to be a part of this, there will be
modifications and changes that can happen as
we move forward as we continue to learn and grow. One of the things I want to make
clear is that through this– through the work of the
Tribal Health Research Office, what we do is that
we don’t let progress suffer from the
evils of perfection. We want to make sure that
we continue to move forward. And it may not be perfect,
but we’re making progress. And with all of your help
we really appreciate this. Some of the things
that are going to be long lasting that
we’ve heard time and time again are workforce
development and capacity. Those are big things that
are going to take time. We’ve begun to engage
the text, and we’re going to continue to
do that, but we’re also trying to educate the
scientific community about how to culturally and respectfully
engage in– ethically engage our tribal communities. So there’s a lot
happening within THRO. We really appreciate
partners like Abigail for providing very clear
comments and recommendations on how we do this. And others in here,
we really thank you for your participation and
our members of our travel advisory committee. Michael’s here as a
representative and chairperson payment. And this is again we’re
increasing our engagement with the tribal
communities to address. One of the four priorities
within the Tribal Health Research Office– actually it’s the first
trans NIH strategic plan for tribal health, and you’ll
be seeing a lot more information coming out about all
the work the agency is doing to address
the specific needs in our tribal communities. So thank you for coming,
and we look forward to receiving your comments. One of the things that
All of Us program may do, I’m not sure if they’re
going to do this or not, but it’s standard practice
for the Tribal Health Research Offices to submit an
RFI so that people who are not in attendance
can submit comments through another mechanism. And we will keep– we usually do our RFIs or
post our RFIs after the final consultation so that there’s– I– we’ve seen that the
comments from tribal leaders, it’s a much more honed
and refined response because they’ve been able to
see all the additional comments leading up to that final RFI. So they usually the comments
are we get back on our final RFI are very concise and very
specific to the ask of what we’re– what’s at hand. So again thank you all, and then
I’ll be wandering around here for the rest of meeting. So look forward to
talking to you both. [INAUDIBLE] Earlier we– I said
that sometimes things get lost in the translation. Tribal leaders, you have
to learn to advocate. Sometimes you speak
different languages. It could be Ojibwe. It could be English. It could be geek. Who said that earlier? Geek? It could be Klingon. But keep advocating
for your people. [INAUDIBLE]

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