Notice2023-13750
Notice To Announce Tribal Consultation for an All of Us Research Program Update and To Discuss the Program's Policies and Protections Around Data Access and Use Statement for Fiscal Year 2023
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Published
June 28, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH) hereby gives notice that the All of Us Research Program will be hosting a virtual Tribal Consultation with American Indian and Alaska Native (AI/AN) Federally Recognized Tribes. The consultation will include an update on our approach to Tribal engagement, discussion about integrating data from self-identified AI/ AN participants in the program's data platform, the All of Us Research Hub at https://www.researchallofus.org, and program planning.
Full Text
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<title>Federal Register, Volume 88 Issue 123 (Wednesday, June 28, 2023)</title>
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[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41974-41975]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13750]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice To Announce Tribal Consultation for an All of Us Research
Program Update and To Discuss the Program's Policies and Protections
Around Data Access and Use Statement for Fiscal Year 2023
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: The U.S. Department of Health and Human Services (HHS),
National Institutes of Health (NIH) hereby gives notice that the All of
Us Research Program will be hosting a virtual Tribal Consultation with
American Indian and Alaska Native (AI/AN) Federally Recognized Tribes.
The consultation will include an update on our approach to Tribal
engagement, discussion about integrating data from self-identified AI/
AN participants in the program's data platform, the All of Us Research
Hub at <a href="https://www.researchallofus.org">https://www.researchallofus.org</a>, and program planning.
DATES: Thursday, September 28, 2023, from 1 to 3:00 p.m. ET. Written
Tribal testimony is due by October 28, 2023.
ADDRESSES: Registration links are available on our Tribal Engagement
website at <a href="https://allofus.nih.gov/tribalengagement">https://allofus.nih.gov/tribalengagement</a>.
Elected Tribal Officials are encouraged to submit written testimony
to <a href="/cdn-cgi/l/email-protection#3776786263455e55565b77595e5f19505841"><span class="__cf_email__" data-cfemail="1859574d4c6a717a797458767170367f776e">[email protected]</span></a>. Please submit on Tribal letterhead by October 28,
2023, with the subject line ``All of Us Tribal consultation written
response.''
[[Page 41975]]
FOR FURTHER INFORMATION CONTACT: Dr. Joshua Denny <a href="/cdn-cgi/l/email-protection#de9f918b8aacb7bcbfb29eb0b7b6f0b9b1a8"><span class="__cf_email__" data-cfemail="51101e0405233833303d113f38397f363e27">[email protected]</span></a>,
301-827-9737. More information is available at <a href="https://allofus.nih.gov/tribalengagement">https://allofus.nih.gov/tribalengagement</a>. The All of Us Tribal Engagement team may also be
reached by email at <a href="/cdn-cgi/l/email-protection#2f6e607a7b5d464d4e436f41464701484059"><span class="__cf_email__" data-cfemail="62232d3736100b00030e220c0b0a4c050d14">[email protected]</span></a>, or by mail at All of Us Research
Program, Division of Engagement and Outreach, Tribal Engagement, NIH,
6710-B Rockledge Drive, 4th Floor, Bethesda, MD 20817.
SUPPLEMENTARY INFORMATION:
I. Background Information
The All of Us Research Program aims to accelerate health research
and medical breakthroughs to enable an era of precision medicine for
all. All of Us is committed to ensuring the program reflects the
diversity of the United States.
In the 21st Century Cures Act (Pub. L. 114-255), Congress
authorized NIH to carry out the Precision Medicine Initiative, which
includes the All of Us Research Program. The law provides NIH with
critical tools and resources to advance biomedical research across the
spectrum, from foundational basic research studies to advanced clinical
trials of promising new therapies, in part through the establishment of
a diverse cohort of individuals to support the goals of All of Us.
II. Tribal Virtual Informational Presentations and Discussions With
Tribal Communities
In June 2023, All of Us held four information and discussion
sessions virtually to continue to engage with Tribal Nations and rural
and urban AI/AN communities. Recorded sessions will be made available
at <a href="https://allofus.nih.gov/about/diversity-and-inclusion/tribal-engagement">https://allofus.nih.gov/about/diversity-and-inclusion/tribal-engagement</a>.
III. Questions
A. Management and Sharing of Self-Identified AI/AN Data (Without Tribal
Affiliation)
1. Integrating information from self-identified AI/AN participants
in our data platform, the All of Us Research Hub at <a href="https://www.researchallofus.org">https://www.researchallofus.org</a>.
(a) How can the program augment the current policies and
protections for self-identified AI/AN participant data so that it can
be shared with researchers?
(b) What additional policies or guidance would you like All of Us
to consider around the use of data from self-identified AI/AN
participants?
2. Honoring Tribal sovereignty when working with self-identified
AI/AN individuals who consent to participate.
(a) What kinds of protective practices and measures can be
implemented to avoid infringing upon Tribal sovereignty when collecting
or working with individual participant data?
(b) How should the program manage and share data from self-
identified AI/AN individuals who choose to participate in the program,
including those who are living off Tribal lands and/or who are not
affiliated with a federally recognized Tribe?
B. Tribal Engagement and Outreach
1. Possible future marketing efforts in zip codes that overlap on
Tribal land and areas bordering Tribal land.
(a) How should the program guide engagement and outreach efforts
where zip codes overlap with Tribal land?
2. Program activities for individual participants on Tribal land.
(a) What protocol should be followed when individual participants
request program materials to be mailed to them or request home visits
on Tribal lands?
C. Program Planning Activities
1. Future inclusion of children in the All of Us Research Program.
(a) What unique considerations are there for the future inclusion
of AI/AN infants, children, and adolescents as participants in the
program, given that a child's parent or legal guardian must be a
current participant?
(b) What unique considerations are there for family-based
enrollment in the research program (e.g., parent or legal guardian
participating with their child)?
(c) What specific factors should be taken into account when
enrolling families in the research program, considering the possibility
of kinship caregivers or non-traditional child care arrangements for
the child?
2. AI/AN traditional blessing ceremony for biosamples of
participants who withdraw from the program.
(a) How should the program proceed in conducting a traditional
blessing ceremony for the participants who self-identify as AI/AN and
request a blessing ceremony prior to the biosample disposition?
Dated: June 22, 2023.
Tara A. Schwetz,
Acting Principal Deputy Director, National Institutes of Health.
[FR Doc. 2023-13750 Filed 6-27-23; 8:45 am]
BILLING CODE 4140-01-P
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