The IRB Role in Indian Communities
The Role of an IRB in Indian Communities…
IRBs help ensure that all research observes three principles of ethics:
1. Respect for persons
2. Beneficence (to do no harm and to maximize benefit)
3. Justice
IRBs look closely at the negotiation between the researcher and each potential volunteer, called the “informed consent” process. Due to concern about tribal sovereignty and self-determination, the Portland Area IHS IRB examines the negotiation both between the researcher and each potential volunteer, and also between the researcher and the tribal community. That is, the Portland Area IHS IRB helps ensure that all research observes the same principles—respect for persons, beneficence, and justice—as it applies to the tribal communities. The Portland Area IHS IRB is committed to the self-determination and cultural integrity of American Indian and Alaskan Native communities.
Three policies reflect that commitment:
By Federal regulations 45 CFR 46, every IRB must have at least one member whose primary interest is “nonscientific.” In the Portland Area IHS IRB, the nonscientific members must be enrolled members of tribal communities. Currently, 71% of Portland Area IHS IRB members are American Indian.
All research and resulting publications must be approved by the governments of the tribal communities involved in the research.
The Portland Area IHS IRB encourages researchers to give, and tribes to ask for, a required set of elements of information to ensure that the tribes’ consent is truly informed. In order for the Portland Area IHS IRB to function, strict guidelines set forth by OHRP have been met. Tribes who wish to have the Portland Area IHS IRB serve as their designated IRB of choice must submit a formalized written request.
Annual Progress Reports
Annual progress reports are usually done at one-year intervals from the date of initial review. The IRB will send an annual renewal form to the Principal Investigator. An annual progress report is considered complete when the investigators provide the following:
Specification as to whether or not there have been changes to the study protocol since the date of last review.
Specification as to whether the research project has been completed since the date of last review.
Total number of subjects enrolled.
Total number of subjects withdrawing from the project.
Total number of subjects withdrawing within the past 12 months of the project.
Identification of all instances of complications or unexpected results of study activity.
Documentation of internal review of results to date.
A complete progress report expedites the review process. If you have any questions, please do not hesitate to contact any individual in the contact lists.
Publications
A manuscript review packet must contain the following items to be considered complete:
If an author is an employee of IHS, the manuscript must include the standard disclaimer: “The opinions expressed in this paper are those of the author and do not necessarily reflect the views of IHS.”
A copy of the tribal approval letter.
The name of the Journal the article will appear in.
Anticipated date for submission of publication.
A copy of the manuscript including authors, title, abstract, article, and references.
