The University of Arizona
Review of Human Subjects Proposals by AIS

Review of Human Subjects Research Proposals by American Indian Studies



With regard to human subjects research, the University of Arizona Human Subjects Protection Program (HSPP) has established the following rule (see p. 32 of Version 2.0 of the Investigator Manual): Human Research that includes Native Americans or an international Indigenous group as part of the study population must undergo expert review prior to the Institutional Review Board (IRB) submission.

This review is required for studies where:
[  ] the research procedures take place in Indian Country or among international Indigenous populations; OR
[  ] the research actively recruits Native Americans or international Indigenous populations for enrollment; OR
[  ] the research requires stratification of Native Americans or international Indigenous populations as one of the statistical analyses or study aims.

For social and behavioral projects involving Native Americans or international Indigenous groups, researchers are asked to submit their project documentation to American Indian Studies (AIS). “Indian Country,” as used in the HSPP Investigator Manual, includes but is not limited to all land within the limits of Indian reservations under the jurisdiction of the United States Government, all dependent Indian communities within the borders of the United States, and all Indian allotments where Indian titles have not been extinguished (as described by 18 USC 1151). It includes tribes recognized by states, and land off reservations for which tribes have retained treaty or other rights.

“Indigenous populations,” as used in the HSPP Investigator Manual, echoes the United Nations in providing a modern understanding of Indigenous Peoples as self-identified cultural groups originating in a country or region who have historical continuity with pre-colonial or pre-settler societies; or who have social, economic, or political systems distinct from the dominant society of the nation state in which they reside. Indigenous Peoples maintain distinct cultures, languages and beliefs; they also have a strong link to territories and resolve to maintain and reproduce their ancestral environments and systems as distinctive peoples. (See “Declaration on the Rights of Indigenous Peoples” from the United Nations.)

American Indian Studies reviewers are asked to judge the adequacy of tribal government approval or community engagement, or both, by the American Indian Tribes or Indigenous groups that are part of the study population. The AIS reviewer provides feedback to the researcher and to the IRB by checking one or the other box in this statement, located on Form 200, Section 1b, Item 6:

I have examined the proposal cited above and approve its conduct as described herein. Further tribal/Indigenous government approval [  ]is [  ]is not necessary.

If further approval is necessary, the first box is checked, indicating that the AIS reviewer has not concurred that tribal government approval or community engagement, or both, is adequate. If the second box is checked, the reviewer has concurred that there is adequate documentation of tribal government approval or community engagement, or both. At present, the Head of AIS reviews IRB applications, although particular research protocols may be referred to someone else with more expertise. A signature on the form documents who has determined whether or not adequate tribal government approval or community engagement has occurred.

The relationship among the various levels of IRB approval are as follows:

  • The Advisor and Department review research proposals for scientific and technical validity.
  • AIS reviews proposals for tribal government approval or community engagement, or both.
  • The IRB reviews proposals for the protection of individual subjects.

As the process of review occurs, each of the levels may comment on the other. For instance, an IRB representative reviewing a proposal will check to see if community engagement is adequate; if AIS and IRB disagree, then some resolution will be necessary. A student’s advisor or departmental reviewer may flag issues that they think the other two levels might disapprove, and ask for correction before sending the proposal forward. Although AIS will not review for scientific or technical validity, researchers should recognize that communities will review proposals for a variety of reasons, which may include scientific validity. Some communities may require substantial changes in a research plan. Indigenous groups should be contacted early and often in the process of development of a research plan.

The best way to determine whether or not a proposal is satisfactory is to submit it for review, with plenty of time remaining to change the proposal if required.

AIS Review Standards

Researchers at the University of Arizona need to know what the Department looks for in its review of research protocols to ensure Indigenous involvement in research projects and protection of community rights. Like the HSPP, the AIS program takes its approach from the Declaration on the Rights of Indigenous Peoples from the United Nations, as well as from procedures established by the Tri-Council of research bodies in Canada and from the general literature on ethics of research with Indigenous Peoples, much of which is referenced in the Native Peoples Technical Assistance Office (NPTAO) website.

Three questions govern the review: (1) Are the people under study Indigenous? (2) What entity is appropriate for providing group/community approval? (3) Is the evidence sufficient to show that free, prior, and informed consent to the research project has been obtained from the relevant community or tribal source?

For instance, in the United States, the answers are as follows: (1) If the research involves a federally or state recognized tribe, then the people are Indigenous; (2) The tribal government or its designated office provides review; (3) Sufficient evidence of consent is approval by the tribal council, as demonstrated by a council resolution or a letter from an approved delegated authority such as the tribal chair, an attorney general or a cultural preservation officer. The consent may be contained in a contract signed by the appropriate authority.

In other situations, such as with a non-federally recognized Indigenous group in the US, an urban study, an international study, or a comparative study involving more than one group, answering the questions is more complex. Throughout consideration of ethical research, the three general principles of respect for persons, concern for welfare, and justice should be addressed in considering community engagement. Respect involves both persons and communities. Welfare involves more than individual welfare; it involves concern for the community or group to which an individual belongs. Addressing justice involves attention to imbalances of power, particularly between researchers and the groups they wish to study.

(1) Are the people under study Indigenous?

Our definition of “Indigenous” is given above. Those wishing further information on the self-identification of Indigenous Peoples should consult the UN Permanent Secretariat on Indigenous Issues; and the available fact sheet. The principle of self-identification is the fundamental criterion, which is consistent also with the way that the US Census identifies and counts American Indians and Alaskan Natives.

(2) What body is appropriate for providing approval?

Given the history of domination experienced by Indigenous Peoples, answering this question is complicated. Principal Investigators need to describe in their documentation the legitimate leadership structure of the group that they are engaging in their research. Preliminary, pre-research discussions in the field may be needed to determine what entities might be appropriate.
The statement in the UA Form 200 refers to “tribal/Indigenous government approval,” which is quite clear when a tribal government is the relevant body. In other cases, AIS finds useful the terminology in Chapter 9 of the Canadian TCPS 2, “community engagement.” Engagement can take many forms of collaboration, and the terminology allows for a wide range of forms of engagement “depending upon the community context and the nature of the research” (TCPS 2, page 108). The explanation of Article 9.2 of the TCPS 2 provides many examples of different forms of engagement (pp. 111-114), and other articles in Chapter 9 deal with specific complexities that can arise.

The first approach of AIS is to assume that a variety of entities already exist, and should be considered as potential partners for research. If absolutely none are available, then the creation of an ad hoc advisory group consisting of some of the individuals who would be interviewed or otherwise involved in the study might provide a forum for providing consent to research. Such an advisory group can have other benefits to the researcher to improve the quality of the results, and might be set up even if the body giving approval is more formal.

(3) Is the evidence sufficient to show that free, prior, and informed consent to the research has been obtained?

Documentation of tribal government approval or community engagement, or both, needs to demonstrate that free, prior, and informed consent for the research has been obtained. The evidence of consent should be sufficient to demonstrate that the consent was provided prior to the research and is based upon adequate information regarding the intent of the research and the ongoing use of the resulting data. If significant risk to the community or group’s interests are involved, that should be recognized and taken into account. Although researchers are rarely in a position to use coercion to acquire consent, the sponsors of the research may have more leverage and issues of relative power should be examined if relevant, to assure that consent is freely provided.

Usually some kind of written document that demonstrates or reports the consent is required. While some groups may not be literate, or there may be other issues related to language, researchers should be inventive regarding providing evidence independent of their own testimony regarding the provision of free, prior, and informed consent.

Submission of HSPP Form 200 to AIS

A complete Application for Human Research (HSPP Form 200) should be submitted to AIS prior to submission to HSPP. In addition to all the items identified in the Submission List for Form 200, be sure to include documentation of tribal government approval or community engagement and consent, or both. If written documentation of tribal government approval or community engagement, or both, is not available, include a narrative statement of how the researcher has proved that this requirement has been met by the proposed research.




American Indian Studies – Trosper – November 2011