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"We must develop expert Indians instead of Indian experts."

Beverly Pigman, institutional review board officer, Navajo Nation

Rocky Mountain Tribal IRB

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The Rocky Mountain Tribal Institutional Review Board (RMT-IRB #IRB00000638) is an administrative body established to protect the rights and well-being of Member Tribes of the Montana and Wyoming Tribal Leaders Council. As fundamental policy, the Tribal Leaders Council (TLC) strives to ensure as many safeguards as possible are in place for the Tribes as unique political entities and to see that grant sponsored activities permitted on the Reservations are conducted in ways that „do no harm‟ to the cultural integrity of Tribes. Precisely because these considerations are of utmost concern to the member Tribes of the Tribal Leaders Council, the Rocky Mountain Tribal IRB is committed to building Tribal infrastructure as a means of strengthening Tribal sovereignty, as well as cultural integrity.

Since our goal is to protect Tribes while increasing respect for both short-term and long range Tribal concerns, the Rocky Mountain Tribal IRB, is obliged to ensure that actual benefit accrues to the respective community, just as much as it does to researchers and grantees who are external to these Tribal infrastructures. Being cognizant of the fact that practicing real respect must be a mutual premise that guides all interactions, we seek open, honest communications with full disclosure and transparency for all of the particulars of any given grant application that includes Tribes, reservation communities or data regarding these native populations.

Protection of individuals as “human subjects” is generally the primary focal point of non-Tribal IRBs and, by contrast, Tribes as whole living entities comprise the focus of the Rocky Mountain Tribal –IRB. Additionally, Rocky Mountain Tribal IRB seeks evidence that research and grant applications serve the primary repositories of Tribal knowledge and wisdom so that the institutional memory of the respective community/ies is enhanced. If anyone is to “own” Tribal Data, then it should be the Tribes themselves first and foremost. Finally, the RMT – IRB seeks to promote culturally appropriate activities and research that is duly authorized by the Tribal governments (or those so delegated by the Tribal government), as the primary authorities on the reservations.

The RMT-IRB has been accorded the authority to approve, require modifications in, or disapprove all research and grant activities as specified by the Office of HumanResearch Protections (OHRP) and federal regulations. In addition, because the Tribes acted as a body in unison through the MT WY Tribal Leaders Council to ensure good research oversight and protections with official Board action, all research or grant sponsored activities that involve two or more member Tribes, must be reviewed by the Rocky Mountain Tribal IRB.

The RMT-IRB is also the IRB of record for the Billings Area Indian Health Service (IRB#0000638), thus, any research involving Indian Health Service facilities, clinicians, providers, patient data, and/or related information will be reviewed by the RMT-IRB.

Research that has been reviewed and approved by the RMT-IRB may be subject to further review, and may be disapproved by the respective Tribe(s). Furthermore, all RMT-IRB approved research is subject to continuing annual review, required reporting of changes, and finally, Protocol Review by the Rocky Mountain Tribal IRB requires inclusion of the total grant application, including the budget.

An Institutional Review Board is a committee designated by the Office of Human Research Protections to approve and review research. The primary goal of an IRB is to protect the welfare of research subjects. Federal guidelines (45 CFR 46) govern the research and review process, the RMT-IRB complies with these guidelines while adding additional protections for the unique cultural, traditional attributes and concerns of Tribal Nations. The RMT-IRB is different than the Indian Health Service IRB or a University IRB with the primary differences being;

  1. Rocky Mountain Tribal IRB serves to protect „communities’ from harm (as well as individuals);
  2. RMT - IRB serves Tribal nations in Montana and Wyoming;
  3. RMT-IRB prioritizes Tribal governments and promotes the Tribe‟s sovereignty; infrastructure development and cultural integrity;
  4. RMT - IRB encourages input from elders or community members when research protocols involve their people;
  5. The RMT - IRB values traditional knowledge and belief-ways beyond western European cosmologies, philosophies and epistemologies,
  6. The RMT - IRB will ensure research protocols address Tribal concerns as expressed by Tribal Leaders and Tribal program staff;
  7. Research which identifies disparities should include intervention plans or suggestions to address findings resulting from research; and finally,
  8. The RMT - IRB requires equitable allocation of resources by the researcher to the Tribal community.

 

Federal guidelines require at least five Board members and the following qualifications:

  •  One member of the Board shall be a clinical provider with a medical degree and training.
  • One member of the Board shall represent the scientific field including biostatistics, biomedical research, and behavioral research.
  •  Two members of the Board shall represent the communities
  •  One member of the Board shall represent special populations to protect the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically disadvantaged persons.
  •  Topic Area Consultants may be recruited by the Board when required by the subject area of the research protocol.

In addition to requirements from federal guidelines and in order to serve Tribes here, the majority of the Board members shall be from the communities of the MT-WY Tribal Leaders Council Member Tribes.

Funding for RMT-IRB

There is no long term or stable funding mechanism to support the RMT-IRB. At present, RMT-IRB is subsidized by the MT-WY Tribal Leaders Council and a small grant from I HS (NARCH V Core). In the future, fees paid by investigators for protocol submission may be required to offset administrative costs associated with RMT-IRB implementation.The goal of the RMT-IRB is to involve researchers and communities in a collaborative process resulting in equally beneficial results.

Staff

Cheryl Belcourt, RMT-IRB Coordinator, NARCH V IRB Core Manager.

Gordon Belcourt, Executive Director, RMT-IRB Chair, Co-PI NARCH V

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