Research Involving American Indian and Alaska Native Persons

The policy applies to research conducted by NIH Investigators that is exempt or non-exempt human subjects research (HSR) and to some research that might be considered “not human subjects research” (NHSR) when the research is:

• likely to include AI/AN communities and/or persons self-identifying as AI/AN and the research will make inferences about AI/AN populations or communities, or
• will use data and/or biospecimens in secondary research that are known to have been collected from AI/AN persons, and the research will make inferences about AI/AN populations or communities. This includes:
  • when any aspect of the research, including recruitment, will take place entirely or in part within tribal jurisdiction (for example, recruitment, or data/specimens collected on Tribal lands or reservations).
  • when the research will intentionally recruit AI/AN persons as participants and/or AI/AN populations are the focus of the research.
  • secondary research using data and/or specimens known to have been collected from AI/AN persons that were originally collected for other purposes (for example, collected for clinical care or under a different research protocol), and will make inferences about AI/AN populations or communities. This includes data and/or specimens that are not readily identifiable to the NIH Investigator and therefore might be considered NHSR.
  • secondary research using data and/or specimens that were originally collected within Tribal jurisdiction, regardless of the aims of the secondary research. This includes data and/or specimens that are not readily identifiable to the NIH Investigator and therefore might be considered NHSR.

The policy applies to research conducted by NIH Investigators regardless of whether the NIH is the reviewing IRB, or an external IRB is the reviewing IRB.

The policy applies to new protocols that will involve AI/AN persons, their data or specimens and meets the conditions stated above. The policy also applies to modifications to an existing protocol that meet the conditions stated above.

Research that may incidentally include AI/AN persons as part of the research is not subject to the policy so long as the following conditions are met:

• the individual is not intentionally recruited as participant based on being an AI/AN person, and
• the research will not make inferences about AI/AN communities or populations.

OHSRP recognizes that seeking Tribal Authority approval is likely an unfamiliar process for NIH Investigators. It may also be tricky for you to figure out if the policy applies to your study. For example, you are planning research that does not intend to study or make inferences about Tribal populations or communities and will take place off Tribal jurisdiction but will recruit from a community known to include a significant population of AI/AN persons. You should seek help; you do not need to figure out this on your own.

If you have any questions or need help, ask OHSRP/IRBO. OHSRP is the office with the final authority to determine if your research is subject to the policy or not.

You should seek guidance about Tribal Authority approvals early in the protocol development process, ideally when planning the research or when determining the feasibility of such research. In addition, when the research will take place on Tribal jurisdiction, it is advised that the IC establish an MOU with the Tribe and specify the obligations of the parties. Coordinate this with your Clinical Director and/or other leadership in your IC.

When the research is subject to the policy, NIH Investigators must:

• consult with the Tribal Health Research Office (THRO) on what Tribal Authority approvals may be needed and for assistance in engaging the Tribes. This is required prior to submission to the IRB. The consult will help you understand if you need to seek Tribal Authority approval before you can start the research. This Tribal Authority approval will be in addition to IRB approval.
• obtain a written recommendation from THRO advising whether Tribal Authority engagement is needed. If the Tribal Authority does need to be engaged, THRO can advise which Tribal Authority should be contacted.
• consult the Tribal Authority prior to submitting the protocol to the IRB when THRO advises that Tribal Authority approval is needed.
• obtain Tribal Authority approval when it is required by the Tribe. Such approval must be obtained and submitted to the IRB. In this case, the NIH IRB will not approve the study without the Tribal Authority approval.
• seek review of your research from another Tribal entity, if required as a condition of Tribal Authority approval. Examples of other Tribal entities are the Tribal IRB, Research Review Board, health department or college. You must get this review as directed by the Tribe.
• submit any Tribal review determinations and Tribal Authority approval along with the written THRO recommendations to the NIH IRB when you submit your protocol.

Tribal Authorities are Tribal governmental entities that have the legal authority to either grant or deny permission for the research to be conducted with Tribal members, their specimens or data. However, Tribal Authorities may depend on other Tribal entities to review such research before granting approval. These other Tribal entities do not have legal authority over the Tribe but are advisory to the Tribal Authority.

These entities may include duly constituted Tribal IRBs, or Tribes may rely upon other duly constituted IRBs. Other examples of Tribal entities include Tribal Councils, Research Review Boards, and Tribal health authorities, colleges or universities. NIH Investigators are expected to follow the direction of Tribal Authorities to seek any required Tribal reviews needed as a condition of Tribal approval.

When seeking a consult from THRO:

• Send an email to THROinfo@nih.gov and cc’ the following people: Sara Hull (shull@nih.gov), Karina Walters (karina.walters@nih.gov), Shiela Caldwell (caldwells@nih.gov) and Heather Bridge (heather.bridge@nih.gov). Include “NIH IRB question” in the subject line.
• Attach the following documentation:
  • protocol describing the intended Tribal populations that will be involved
  • informed consent(s)/assent(s)
  • recruitment materials, and
  • Any surveys and other data collection instruments, especially those related to demographics (for example, Tribal affiliation)

When Tribal Authority approval has been received, submit it along with any Tribal entity review determinations and the written THRO recommendations to the NIH IRB. Research may not start until both required Tribal Authority approval and IRB approval been received. This includes NIH IRB or external reviewing IRB, as well as Tribal IRB when required by regulation.

If your reviewing IRB is an external IRB, submit these same materials to the IRBO so they can be incorporated into local context information for the reviewing IRB. If Tribal Authority approval is required, IRBO will not clear you to submit to the reviewing IRB if these materials are missing.

For multisite research, when Tribal IRB review is required by the Tribal Authority and review by more than one IRB is permitted by the 2018 Common Rule (45 CFR 46) for multisite research, then you must seek review by the duly constituted IRB designated by the Tribe. This is in addition to NIH IRB review.

However, when the requirements of single IRB review under the 2018 Common Rule do not permit review by more than one IRB, but the Tribal Authority requires you to obtain review from another Tribal entity such as the Tribal IRB, you must comply. In this case, NIH IRB will use the determination from the Tribal IRB as local context in its review of the study.

Research that is subject to the policy will be reviewed by the convened IRB, including research that may be considered minimal risk. This includes initial reviews and modifications that are substantive in nature.

When reviewing this research, the convened board will be comprised of a majority of members who are AI/AN, when feasible.