American Indian/Alaska Native (AI/AN) tribal nations are communities with distinctive social, cultural, and spiritual qualities that embody a unique context for the review and conduct of research. AI/AN tribal nations have developed a variety of research review mechanisms that are tailored to specific community needs and interests.
Recently, both the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) solicited public comments on policy proposals that promote the use of a single Institutional Review Board (IRB) of record for review of multi-site research. The explicit goal of these policies is to reduce procedural inefficiencies and redundancies associated with multiple IRB reviews. According to both the Final NIH Policy on the Use of a Single IRB for Multi-Site Research and the Notice of Proposed Rulemaking (NPRM) to the Federal Policy for the Protection of Human Subjects, exceptions would be permitted in some circumstances, such as when local IRB review is required by federal, tribal, or state laws or regulations.
Policies to promote the use of single IRBs for multi-site research raise important questions related to the oversight of research in AI/AN tribes. A number of public comments were submitted in response to the draft policies by and on behalf of AI/AN tribes, all of which emphasized the importance of maintaining a role for local tribal review of research to ensure appropriate consideration of unique tribal interests. Many commenters called for a more explicit recognition of the legal jurisdiction of tribal nations and their role in protecting human subjects to ensure that they do not become overlooked or marginalized.
Neither the final NIH policy nor the NPRM provide specific guidance on how to identify, operationalize, and enforce exceptions to the proposed rules. It falls upon individual federal agencies and NIH Institutes to develop policies and procedures that are tailored to specific cases.
PRIM&R is pleased to present this complimentary webinar in collaboration with Northwest Indian College, which aims to provide recommendations for future guidance with regards to operationalizing the exceptions clause, and to reinforce the vital role local review plays in AI/AN research. Using case studies, speakers will cover the following:
- The historical and ethical foundations for tribally based review
- Models and mechanisms for review that are unique to tribes, and how they currently fit into multisite research with AI/AN tribal populations
- The final NIH policy and NPRM single IRB mandates, and comments and concerns related to the potential impact of these policies on AI/AN research
- Considerations for future guidance regarding operationalization of the exceptions clause in this new regulatory landscape
What will I learn?
After attending this webinar, attendees will:
- Appreciate the unique and vital role review by tribes and review by tribally-based IRBs plays in research with AI/AN tribes, communities, and individuals
- Understand the potential impact of single IRB policies on tribally based review, and the potential impact of tribally based review on single IRB policies
- Be better equipped to engage in a dialogue about preserving local review via the exceptions clauses
Who should attend?
This intermediate-level webinar will benefit IRB professionals, IRB members, and researchers who are currently responsible for reviewing and conducting research with AI/AN communities, as well as those who may review this type of research in the future. This webinar will also be of interest to program officers from funding agencies and those involved with granting exceptions under single IRB policies.
Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification. Learn More »
In Collaboration with Northwest Indian College
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