Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) (R24 - Clinical Trial Not Allowed)

The Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) program, funded by the National Institute of General Medical Sciences (NIGMS), aims to strengthen research autonomy and oversight for American Indian and Alaska Native (AI/AN) communities by supporting federally recognized Tribes, Tribal colleges, health programs, and organizations in establishing or enhancing Institutional Review Boards (IRBs). This initiative addresses long-standing health disparities and trust issues within AI/AN communities by bolstering their capability to independently oversee human subjects research, reducing reliance on external IRBs. Key objectives include supporting the development of culturally appropriate IRBs that reflect the priorities and needs of Tribal health research, ensuring proper regulatory oversight, and fostering increased Tribal control over research involving Tribal members. Eligible applicants are federally recognized AI/AN Tribes, Tribal colleges and universities, Tribal health programs, or organizations, with the option to apply as a consortium. Applications must include a plan for building a new IRB or strengthening an existing one. Supported activities under this funding opportunity include hiring IRB staff, developing operational policies and infrastructure, implementing data management systems, and training IRB members on federal, institutional, and Tribal research regulations. Training should emphasize culturally relevant, competency-based education, aiming to prepare Tribal members to serve on IRBs effectively. The TIRBEE grant supports projects with budgets up to $350,000 in direct annual costs over a maximum project period of five years. Subcontracts to non-Tribal partner organizations must not exceed 25% of the direct cost budget. Additionally, each applicant may only submit one proposal, and foreign components are allowed only if they support Tribal entities spanning the U.S. border. To maintain compliance, all applicant organizations must complete required registrations through SAM.gov, Grants.gov, eRA Commons, and obtain a NATO Commercial and Government Entity (NCAGE) code for international collaborations if applicable. Applications should include a Tribal Letter of Commitment and focus on four primary components: program description, regulatory competencies plan, IRB development plan, and sustainability plan. The program description should explain the current IRB capabilities and goals for expansion, while the regulatory competencies plan should outline the training and certification necessary for staff and IRB members. The IRB development plan should detail operational structure, data management, and procedures for IRB functionality, and the sustainability plan should describe strategies to ensure long-term viability of the IRB infrastructure, including possible revenue models and contingency staffing. The application process emphasizes strict adherence to NIH guidelines, with a deadline on January 27, 2025. The review process will evaluate applications based on significance, investigator expertise, innovation, approach, and environmental resources. Successful applicants will receive feedback and guidance to refine their IRB capabilities, with priority given to applications that demonstrate a significant potential for positive impact on Tribal health research autonomy. Awards will be made based on scientific merit, alignment with program priorities, and availability of funds. Throughout the project period, grantees are expected to submit annual reports detailing progress toward achieving project milestones, including IRB training completions, operational improvements, and user growth. NIGMS will evaluate the program’s effectiveness over time, assessing metrics like the number of new IRBs registered, IRB reviews conducted, and growth in IRB-trained staff. For inquiries, applicants may contact NIGMS scientific, peer review, and grants management contacts as specified in the announcement.