Working with All of Us data shared by American Indian and Alaska Native participants

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Introduction and importance

The mission of the National Institutes of Health’s All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for everyone. This mission to improve health includes a charge to support ethical and respectful use of data contributed by All of Us participants who self-identify as American Indian and/or Alaska Native (AI/AN) and not do harm through the conduct or outcomes of that research. The handling and analysis of all data shared with the All of Us Research Program is sensitive to individuals and their communities. For data contributed by self-identified AI/AN participants, there are unique protections and ethical obligations that researchers must consider.

Researchers’ use of data contributed by AI/AN participants has the potential to affect AI/AN communities of all types, including those in Tribal jurisdictions and urban areas. This resource was created to aid researchers who access the All of Us Researcher Workbench and intend to use data contributed by All of Us participants who self-identify as AI/AN.

Background and historical context

All of Us is working to better include, welcome, affirm, and respect the health and social issues that are important to AI/AN populations. AI/AN individuals are underrepresented in biomedical research for many reasons. For example, some AI/AN individuals may be hesitant to participate in research due to past and present transgressions by academic and federal institutions1-4.

While AI/AN is often thought of as indicating a racial and/or ethnic identity, it also has political and legal meanings for AI/AN peoples and Tribal Nations. There are 574 Tribal Nations in the United States that are recognized as sovereign governments with special legal and political relationships with the U.S. federal government (known as “federally recognized tribes”)5.

All of Us considers the needs of highly diverse groups of AI/AN individuals, communities, and Tribal Nations in its policies regarding data contributed by participants who self-identify as AI/AN.

How participants who self-identify as AI/AN joined All of Us

Individuals living anywhere in the United States and its territories who meet eligibility criteria can consent to participate in All of Us. Because of Tribal Nation sovereignty, All of Us does not actively conduct recruitment or enrollment activities within Tribal jurisdictions6. Individuals living within Tribal jurisdictions can enroll in the program through enrollment centers outside of Tribal jurisdictions or via the program’s online portal.

Any future recruitment within Tribal jurisdictions would only take place with consultation and approval from the Tribal Nations presiding over those jurisdictions and through a resulting partnership with those Tribal Nations. To date, the program has not entered any such partnerships. Of note, not all Tribal Nations in the United States have human ethics research institutional review boards. In addition, the program lacks resources to track each participant’s Tribe. Because of these and other factors, it was not feasible to attain approval from every Tribal Nation with which participants who self-identify as AI/AN may be affiliated prior to beginning enrollment in the program.

All of Us has ongoing consultations with Tribal leaders and conversations with community members across the country to better understand the views and concerns of AI/AN communities and find ways to build a strong program together. The program is committed to protecting the rights of AI/AN and Indigenous Peoples who are seeking to enroll in the program, in partnership with Tribal Nations and Urban Indian organizations.

Benefits of All of Us for AI/AN communities

All of Us welcomes people from all communities, especially those that have been left out of research in the past. AI/AN individuals are underrepresented in health research and often are not included in sufficient numbers to achieve statistical significance in population surveys or studies using big data. When more individuals from communities underrepresented in research take part in studies, researchers can close information gaps and find ways to improve health for all.

All of Us is making data from self-identified AI/AN participants available in accordance with our policies and guidelines from Tribal consultations. By making these data available, All of Us is honoring the contributions of those participants and their desire to further health research on behalf of their communities.

Some participants may choose to join All of Us because of the information they may receive about their own health. Some may also choose to join because contributing data may help improve the health of their community. Discoveries made with these data may result in future improvements to the clinical care participants receive. For example, a study of All of Us participants’ genetic data recently prompted the medical community to update recommendations that help doctors choose the right chemotherapy dosage for people with certain types of cancer. In the future, research results like this may inform health care practices, which could help improve the health of many people. Ultimately, this could help further health equity by making precision medicine more accessible.

Broadly accessible data

The All of Us dataset is accessible to researchers worldwide whose institutions have Data Use and Registration Agreements with All of Us. The program has put protections in place to safeguard privacy and support responsible use. The program and its partners also provide support and training resources at no cost to researchers interested in using All of Us data. By making the dataset widely accessible and providing support and training resources, the program hopes that researchers from different backgrounds and communities will be able to make use of the data7. This could open up new lines of inquiry that could eventually return value to communities that have been underrepresented in research.

The All of Us Research Program has committed to respecting Tribal sovereignty by working with Tribal Nations to ensure that research using data contributed by AI/AN participants is conducted in a respectful and responsible manner.

Future Tribal partnerships

In the future, All of Us seeks to enter formal partnerships with Tribes, which would give Tribes the ability to characterize and control their members’ data. This would allow Tribes to conduct research themselves based on their own research priorities or partner with others conducting research driven by Tribal goals. Through partnerships with Tribes and the inclusion of previously underrepresented groups, such as AI/AN individuals, the program aims to support new insights that advance health for all.

All of Us data access and use requirements

Researchers must understand their responsibilities when performing research with implications for AI/AN individuals and communities. These responsibilities are discussed in the All of Us Responsible Conduct of Research training, which researchers must complete during the Researcher Workbench registration process. This training covers topics like the potential for research to cause community and group harm and the need for researchers to exercise cultural humility. It also provides guidance on topics like the appropriate use of population descriptors, protecting participant privacy, and responsibly communicating and disseminating scientific findings.

To register for the Researcher Workbench, researchers must agree to and sign the Data User Code of Conduct (DUCC). In the DUCC, researchers agree to adhere to program’s core values, comply with laws and regulations, respect participant privacy, and use the data solely for biomedical or health research. The DUCC also emphasizes responsible handling of external data, prohibits stigmatizing research, and sets restrictions on sharing participant-level data. When researchers sign the DUCC, they also agree to abide by accompanying data use policies, including the program’s policies on stigmatizing research, ethical conduct of research, and respectful research involving AI/AN populations.

The All of Us Respectful Research Involving American Indian and Alaska Native (AI/AN) Populations policy details additional policy requirements and considerations for researchers conducting research with implications for AI/AN individuals and groups. Researchers are encouraged to read the full policy for more information.

The DUCC requires registered researchers to establish a project workspace for each unique research project. For each workspace, registered researchers must create a “meaningful and accurate description of [the] research purpose” at the time of workspace initiation. These descriptions are posted publicly in the Research Project Directory. Workspaces and descriptions may be reviewed for compliance with the terms of the DUCC upon public or user request or during periodic audits of the Researcher Workbench. These reviews are conducted by the All of Us Resource Access Board (RAB). If a RAB review determines a registered researcher has violated the program’s terms of use, the researcher may be subject to penalties, as described in the DUCC:

I acknowledge that failure to comply with the requirements outlined in this Data User Code of Conduct may result in termination of my All of Us Research Program account and/or other sanctions, including, but not limited to:

  • The posting of my name and affiliation on a publicly accessible list of violators, and
  • Notification of the National Institutes of Health or other appropriate entities about my actions.

I understand that failure to comply with these requirements may also carry financial or legal repercussions. Any misuse of the All of Us Research Hub, Researcher Workbench, or data resources is taken very seriously, and other sanctions may be sought.

Self-identified race and ethnicity

All of Us acknowledges the diversity of Tribal Nations and AI/AN individuals and recognizes that there is no singular source that can represent all Tribes. When completing The Basics survey, All of Us participants self-report the racial and ethnic categories they feel represent their identity. This means that participants may self-identify as AI/AN alone or AI/AN in combination with one or more additional racial and ethnic categories. All of Us does not ask for verification of Tribal enrollment or descendancy from participants who self-identify as AI/AN. Self-identifying as AI/AN does not denote official enrollment or descendancy status with a Tribe.

Demographic data may also be included in electronic health record data shared by participants. However, racial misclassification has been documented as an issue affecting AI/AN data, and the program recommends using participants’ self-identified demographic categories from The Basics8.

Tribal affiliation

Tribal membership and citizenship are determined by each Tribe. Tribal sovereignty includes the right for Tribes to control their identity, including reference or inference to Tribes in research.

In response to The Basics survey question, participants may self-report their Tribal affiliation in a free-text box. This may not correspond to formal membership or citizenship. All of Us will not allow researchers to access participants’ self-reported Tribal affiliation without approval from Tribal Nations and their respective or designated institutional review boards.

When working with genomic data, researchers should remember that genetic markers are not indicators of Tribal enrollment or descendancy. Furthermore, genetic similarity to populations with inferred Indigenous American genetic ancestry does not imply that an individual may claim Tribal citizenship.

The All of Us policy on respectful research involving AI/AN populations explicitly prohibits researchers from using personally identifiable information (PII) in conjunction with All of Us research resources. The All of Us definition of PII includes information about Tribal affiliation or descendancy, such as from Certificates of Degree of Indian or Alaska Native Blood (CDIB).

All of Us first learns that participants identify as AI/AN when they answer the following question in The Basics survey:

Which categories describe you? Select all that apply. Note, you may select more than one group.

Participants who select the following option alone or with other categories are identified as AI/AN within the dataset:

  • American Indian or Alaska Native (For example: Aztec, Blackfeet Tribe, Mayan, Navajo Nation, Native Village of Barrow (Utqiagvik) Inupiat Traditional Government, Nome Eskimo Community, etc.)
    • Branching Logic if “American Indian or Alaska Native” is selected:
    • American Indian
    • Alaska Native
    • Central or South American Indian
    • None of these fully describe me (display optional free text)

Branching logic: If “American Indian,” “Alaska Native,” or “Central or South American Indian” is selected:

Provide the name of the Tribe in which you are enrolled or affiliated or your Tribal descent (For example: Aztec, Blackfeet Tribe, Mayan, Navajo Nation, Native Village of Barrow (Utqiagvik) Inupiat Traditional Government, Nome Eskimo Community, etc.)

This question is optional. Participants may choose to skip it.

How All of Us developed The Basics response options

The program developed the AI/AN response options in The Basics survey from descriptions used by the U.S. Census Bureau: “A person having origins in any of the original peoples of North and South America, including Central America, and who maintain Tribal affiliation or community attachment.”

Health care coverage

AI/AN individuals may receive health care through the Indian Health Service (IHS), Tribal health care organizations, or other local health care organizations.

In The Basics survey, participants are asked to report what kind of health insurance or health care coverage they use. IHS is a response option they can select. Although IHS is a federal health care provider for citizens and descendants of federally recognized AI/AN Tribal Nations, researchers should not use a respondent's selection of IHS as a source of health care coverage as a proxy for Tribal citizenship or descendant status or to otherwise infer Tribal affiliation.

When discussing IHS coverage, researchers should not refer to IHS as an “insurance program” or perpetuate the misconception that it is analogous to one.

ZIP code and location data

AI/AN individuals live in diverse geographic settings, including rural, reservation, and urban communities throughout the United States, with the majority residing outside of Tribal jurisdictions9. The proportion of AI/AN individuals living outside Tribal boundaries has increased over the past several decades. More than 67% of the nation’s 4.1 million self-identified AI/AN individuals live in urban areas10. This is due to many factors, including federal policies aimed at assimilating AI/AN individuals. This population is often referred to as “urban Indians.”

Researchers working with All of Us data are prohibited from using participant residential or geographic data to infer AI/AN status or Tribal affiliation. Participants who self-identify as AI/AN may live in regions near Tribal Nations with which they are not affiliated.

Limitations

All of Us data indicating an individual is AI/AN is based solely on self-report and does not correspond to formal Tribal membership, citizenship, or recognition by Tribal governments. This fundamental limitation, combined with the program's explicit restriction on recruitment and enrollment activities on Tribal lands, creates significant constraints on data interpretation and generalizability to Tribal Nations and AI/AN populations more generally. Early comparative analyses to external datasets volunteered by Tribes living on Tribal land have revealed substantial differences when compared to self-identified AI/AN participants in All of Us, including variations in demographic composition, socioeconomic indicators, health care access patterns, and cultural practices. Furthermore, each Tribe has sovereignty to determine criteria for enrolling members, descendants, or affiliated Tribal members.

Recommendations

Given these limitations, researchers utilizing All of Us data should explicitly acknowledge these constraints in their methodology, avoid generalizing findings to broader AI/AN populations, consider the predominantly urban and non-Tribal land context of the data, and complement their analyses with data from other sources when attempting to understand health patterns in AI/AN communities. Additionally, researchers should frame their questions within the specific context of self-identified AI/AN individuals in non-Tribal settings and consider collaborative approaches with Tribal-based research initiatives for more comprehensive understanding.

Additional assistance

Researchers should also consult relevant documents from the Department of Health and Human Services and the National Institutes of Health, including “American Indian and Alaska Native Research in the Health Sciences: Critical Considerations for the Review of Research Applications,” “Considerations for Researchers Working With AI/AN Communities,” and “Supporting Ethical Research Involving American Indian/Alaska Native Populations.”

The All of Us Tribal Engagement and Outreach Branch (TEOB) can assist with questions about using AI/AN data, such as how to describe AI/AN populations. Email AoUTribal@nih.gov to contact the All of Us TEOB.

 

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8 Jim MA, Arias E, Seneca DS, Hoopes MJ, Jim CC, Johnson NJ, Wiggins, CL. (2014). Racial misclassification of American Indians and Alaska Natives by Indian Health Service Contract Health Service Delivery Area. American Journal of Public Health. 2014;104(S3):e1-S503. https://doi.org/10.2105/AJPH.2014.301933
9 Congressional Research Service. Tribal Lands: An Overview. Washington, D.C.: Library of Congress; October 14,2021. https://crsreports.congress.gov/product/pdf/IF/IF11944.
10 Urban Indian Health Commission. Invisible Tribes: Urban Indians and Their Health in a Changing World. Seattle: Urban Indian Health Commission, 2007. https://www2.census.gov/cac/nac/meetings/2015-10-13/invisible-tribes.pdf

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