Today, the All of Us Research Program released a draft version of its Tribal Consultation Report. The program has been undergoing a comprehensive consultation process with tribal leaders, begun in May 2019, to collect input and feedback about how All of Us can thoughtfully and respectfully include American Indian and Alaskan Native (AI/AN) individuals in the program. The draft report summarizes the program’s commitment to Tribal Nations, findings from the consultation process, and planned initiatives for AI/AN engagement and inclusion.
“All of Us is committed to engaging AI/AN populations in a way that respects tribal sovereignty, laws, and cultural customs,” said Stephanie Devaney, Ph.D., chief operating officer for All of Us. “Our goal is to improve health equity by increasing diversity in medical research—and the program has great potential to improve health outcomes for AI/AN populations by closing gaps in representation—but we need to make sure we include these communities in a way that’s guided by input and feedback from tribal leaders. We are grateful to tribal leaders for their close collaboration with us as we chart the path forward together, and we look forward to receiving feedback on this draft report.”
In the report, the All of Us program defines key commitments to AI/AN communities. These 12 commitments reflect the foundational promises to Tribal Nations under which All of Us will continue to operate.
The report is grounded in five themes—based on the issues that emerged throughout the consultation period and distilled from listening sessions, consultation events, and written feedback. Some notable takeaways include the following:
- Tribal Sovereignty and Research Participation: All of Us respects tribal sovereignty and is engaging tribes to make sure that the program’s research is done in a way that upholds tribal customs, cultures, and laws. The program will never recruit on tribal lands or show the tribal affiliations of self-identified AI/AN participants without a tribe’s agreement.
- Cultural Sensitivity and Awareness of Past Harm: AI/AN communities have suffered harm perpetuated through research, contributing to persistent underrepresentation in studies. All of Us will work with tribes to define practices that account for certain cultural preferences and beliefs, such as with the management of tribal members' biosamples.
- Data Access, Use, and Protection: All of Us participant data and biospecimens always have obvious personal identifiers removed in compliance with the Common Rule. The program is committed to working with tribes to ensure an understanding of the robust All of Us participant consent process, and the program has established a policy to prevent or minimize harmful or stigmatizing research. The program is also considering additional policies and procedures to protect AI/AN data against harmful or stigmatizing research, including drawing on AI/AN subject matter experts to potentially review AI/AN-specific research proposals and notifying the NIH Tribal Advisory Committee of research violations. Additionally, the program will implement a training module for researchers on the use of AI/AN data.
- Governance: All of Us appreciates the need for more AI/AN members within its governance. Currently, the program has AI/AN representation on its Institutional Review Board (IRB), Resource Access Board, and Biospecimen Access Policy Task Force. In addition, the All of Us IRB will call on subject matter experts in instances that would require additional AI/AN expertise to provide a more appropriate review.
- Sensitive Data and Preventing Re-identification: While personally identifiable information is always removed from All of Us data, the program acknowledges that data from smaller populations—like AI/AN communities—requires special considerations due to the higher risk of re-identification. For that reason, the program has special practices in place to emphasize privacy and lower the risk of re-identification.
Currently, the program is not actively recruiting any AI/AN individuals, sharing data from self-identified AI/AN participants for research, or processing samples from self-identified AI/AN participants until the tribal consultation process is complete. The comment period for tribal leaders to provide feedback on the draft report will extend through October 16, 2020. All of Us will then finalize the report and make it publicly available on the All of Us Tribal Engagement website.
Read the full draft report PDF | 453.06 KB.