Research Involving Native American & Indigenous Populations

Overview

Research involving Native American and Indigenous communities requires thoughtful attention to tribal history, culture, and sovereignty¹. These communities have distinct identities and cultural traditions and may experience research through the lens of past exploitation or harm. In what is now called Maine, Indigenous people are part of the Wabanaki Confederacy, which includes the Mi’kmaq, Maliseet, Passamaquoddy, and Penobscot nations. Investigators are responsible for conducting research in a manner that is respectful, collaborative, and grounded in ethical principles. Standard human subjects’ protections, such as informed consent and minimizing risk, must be supplemented with culturally appropriate practices that recognize community relationships and historical context.

This resource provides additional requirements and guidance for UMaine investigators conducting research including Native Americans and Indigenous populations, where:

• The research takes place in Indian Country, and/or on land under the control or jurisdiction of a sovereign tribe or among International Indigenous populations; or
• Human subjects research is conducted in Indian Health Service (IHS) facilities or involving IHS staff or resources; or
• The research directly recruits² Native Americans or Indigenous populations for enrollment or participation; or
• The research may foreseeably result in conclusions or generalizations about an Indian Tribe or Indigenous community and/or its members; or
• The research collects, evaluates, publishes, or otherwise disseminates data that has implications for an Indian Tribe or Indigenous community.

The additional requirements outlined in this guidance ensure such research is conducted ethically, transparently, and in partnership with the communities involved.

Relationships with Tribal Communities

Researchers are strongly encouraged to establish relationships with and within tribal communities prior to designing their study. Building trust and mutual understanding helps ensure that the research methods and outcomes are meaningful and respectful to the communities involved, and in a way that benefits both the community and the researcher and the research community.

Whenever possible, tribal members or representatives should be engaged in shaping the research, including the development of goals, methodologies, and data dissemination plans. This collaborative approach supports the ethical principle of respect for persons and reinforces the understanding that tribes are equal partners in the research process.

When submitting an Institutional Review Board (IRB) application, investigators should briefly describe any existing or newly established relationships with the target tribal communities. This includes meetings with tribal representatives and taking steps to involve the community in the design and outcomes of the project. Researchers should also indicate how they intend to maintain ongoing communication and transparency throughout the course of the research, as applicable.

Tribal Permission

Although the Wabanaki communities in Maine do not have formal tribal ethics boards, researchers must still obtain appropriate permission to conduct research in tribal communities or with their members. If working with tribal nations outside of Maine, investigators should research the protocols of the tribes they are interested in and submit their research to any local ethics committees or boards as required.

Written permission may come from tribal councils, elders, or other recognized leadership, depending on the governance structure of each community. Investigators should identify who holds decision-making authority within the community and seek approval in a manner consistent with tribal processes. These may vary across Native and Indigenous nations and should be approached with respect and cultural awareness.

Documentation of tribal permission or local ethical review should be included with the IRB application. If written permission is not possible due to community preference or custom, investigators should provide a summary of the steps taken to engage leadership and obtain oral or informal approval, along with a rationale for the approach used.

Benefit for Tribal Nations

Research with tribal communities should provide a clear and meaningful benefit to the participating nations. Investigators are expected to consider how their work may support tribal priorities, contribute to community well-being, or build local capacity through education, resources, or shared knowledge.

When submitting an IRB application, researchers are expected to describe the anticipated benefits of the study and how these will be communicated or returned to the community. This may include accessible reports, presentations, or other forms of knowledge-sharing tailored to the needs and preferences of each community.

Joint Ownership of Data

Research involving tribal participants should reflect principles of shared authority over data. Investigators must recognize the collective nature of Indigenous knowledge and the importance of community input in decisions about how data are used, stored, and shared.

Whenever possible, data collected through research with tribal communities should be considered jointly owned by the researcher, the community, and the individual participant³. If applicable, it may be appropriate in tribe-specific studies for investigators to assume all participant data will be shared with the tribe unless a participant actively opts out of having their data shared. Ultimately, investigators should discuss data access, storage, and future use with tribal representatives early in the research process and document any agreements reached, as appropriate.

IRB applications should include a description of how data stewardship will be managed, including plans for data sharing and limitations on secondary use. The application and consent form must clearly state how the data will be used. The application and consent form should state that any identifiable data sharing beyond the researchers may only happen with explicit approval from the tribe and/or research participants. Researchers should avoid making unilateral decisions about dissemination or publication without consultation, particularly when findings may affect the community’s interests or representation.

Footnotes

1. The National Institute of Health (NIH) has issued notice NOT-OD-22-214 (external link) recognizing the sovereignty of Native American and Indigenous tribes when conducting research within these populations. ↩︎
2. Directly recruits is used in this guidance to exclude the indirect or incidental recruitment of Native American populations in research. For example, while distribution of an anonymous survey studying the role of sunlight exposure on sleep patterns through social media platforms may result in the participation of individuals belonging to tribal nations, such is not considered direct recruitment of Native American populations for purposes of this Institutional Review Board (IRB) guidance. ↩︎
3. Please see Sample Participant Agreement Worksheet for Research Involving Native American & Indigenous Populations (Word). ↩︎

References

• University of Wisconsin-Madison: Tribal Research (external link)
• University of Southern California: American Indian & Alaskan Native Populations (external link)
• University of New Mexico: Guidance on Research with American Indian Communities (PDF) (external link)
• Oregon State University: Tribal Populations (external link)
• University of Alaska Fairbanks: Research with Indigenous Peoples (external link)
• Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data (external link)

Guidance last updated: July 2025