Additional steps and protections are often needed when conducting research in collaboration with American Indian or Alaska Native (AI/AN) communities and populations. The Common Rule affirms that each tribe may have its own definition of research and its own set of research protections and laws that may have more restrictions than the Common Rule. Additionally, single IRB review is not required when it would be contrary to tribal law. Researchers must receive appropriate review and approvals from the tribe for their research. If a tribe requires its own approval in place prior to IRB approval, upload documentation of the tribe’s approval in ARROW to the AI/AN Communities page in the nPBA or, if using the PBA or sIRB application, the Supplemental Information page.

NIH has issued Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data for the responsible and respectful management and sharing of AI/AN participant data under the DMS Policy.

Researchers who intend to conduct NIH funded or supported research to collect and share data from AI/AN communities should review the NIH Supplement. A summary is below:

• Tribal sovereignty means that Tribal Nations have the right to control how biomedical research can be performed within Tribal jurisdiction, including how their data can be collected, used, managed, and shared.
• Tribal sovereignty includes the right for each AI/AN Tribe to establish and enforce Tribal laws, regulations, and policies for biomedical research, and may include additional protections for research participants beyond those in the Common Rule.
• Awareness of past research abuses perpetrated against AI/AN Tribes, including instances of data misuse, should be well understood. Proactive and transparent conversations with Tribes around how data and/or biospecimens will be managed and shared are of paramount importance.
• AI/AN organizations have advocated for data disaggregation and analyses of AI/AN data, while respecting Tribal sovereignty, to better understand health disparities, protective health factors, and health outcomes of AI/AN communities. NIH’s inclusion policy may also apply, which requires reporting of cumulative subject accrual and progress in conducting analyses for differences by race and ethnicity.

The Supplement further describes best practices around planning for data management and sharing; including engaging AI/AN Tribes, establishing mutual understandings, incorporating AI/AN preferences, considering additional protections and limitations, informed consent practices, and safeguarding against future risks.

More information on tribal research can be found here. UW-Madison also has a Tribal Relations Office. The Tribal Relations Office should be advised of your research project.