Notice Number: NOT-PM-19-004

Key Dates
Release Date: September 3, 2019
Response Date: October 31, 2019

Issued by
All of Us Research Program, Office of the Director, National Institutes of Health (NIH)

Purpose

Purpose: The purpose of this Request for Information (RFI) is to invite additional comments and suggestions on the concerns and challenges communicated by Tribal leaders and participants at the National Institutes of Health (NIH) 2019 All of Us Research Program Tribal Consultation. All of Us seeks to develop approaches to create meaningful, culturally appropriate collaborations with Tribal Nations that aim to benefit the health of Tribal communities and respect Tribal sovereignty.

Background: The All of Us Research Program is a historic effort to gather data from one million or more people living in the United States to accelerate research and improve health. By taking into account individual differences in lifestyle, environment, and biology, researchers will uncover paths toward delivering precision medicine. For further information, please access the program FAQs.

All of Us is committed to ensuring that the program reflects the diversity of the United States and hopes to collaborate with Tribal Nations to facilitate the inclusion of American Indian and Alaska Native (AI/AN) populations in the program. The program recognizes that Tribes are sovereign nations and began government-to-government consultation with AI/AN Tribal Nations in Spring 2019 to ensure that issues and concerns related to research among AI/AN communities are understood. In preparation for Consultation, the All of Us Research Program conferred with the NIH Tribal Advisory Committee, convened the Tribal Collaboration Working Group, spoke with Tribal leaders and researchers, requested listening sessions, and conducted an informal literature review. A complete list of Consultation events that occurred after these initial steps, supporting materials, and resources is available at https://allofus.nih.gov/about/all-us-tribal-engagement.

Information Requested:

Please provide comments or additional input to any or all of the following topics, or any other topic about which you wish to write. Broadly speaking, these topics encompass the overarching themes communicated by Tribal leaders and participants during the All of Us Research Program 2019 Tribal Consultation:

• Respecting Tribal sovereignty when the program begins recruitment of AI/AN individuals, regardless of Tribal land residence;
• Challenges with handling data from self-identified AI/AN individuals;
• Concerns with individual re-identification in areas with small populations;
• Educating the research community on avoidance of stigmatizing research;
• Concerns with the current NIH All of Us model of informed consent for broad secondary use of de-identified data and samples;
• Challenges with accommodating limited computer access and English proficiency in some communities;
• The importance of proper handling of AI/AN biospecimens in accordance with Tribal beliefs and traditions;
• Concerns with data access, privacy and security, particularly with medical record access;
• Concerns with conducting research with data where Tribal members may be incidentally included as part of the general population, and the study does not specifically focus on AI/AN populations;
• Concerns with conducting research that specifically focuses on studying AI/AN populations with All of Us data.

How to Submit a Response:

Responses to this RFI will be accepted through October 31, 2019.

All comments must be submitted via email to [email protected].

All submissions will be considered but will not be confidential. Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

Inquiries

Please direct all inquiries to:

All of Us Research Program Tribal Engagement
[email protected]
Call/text: (240) 515-5317