Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) Program

Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) Program is sponsored by National Institute of General Medical Sciences (NIGMS), NIH. This program supports federally recognized American Indian/Alaska Native (AI/AN) Tribes, Tribal colleges and universities, Tribal health programs, or Tribal organizations to establish institutional review boards (IRBs) or enhance the capacity of existing Tribal IRBs.

PAR-24-260: Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) (R24 - Clinical Trial Not Allowed) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of General Medical Sciences ( NIGMS ) Funding Opportunity Title Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) (R24 - Clinical Trial Not Allowed) R24 Resource-Related Research Projects March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. October 2, 2024 - Notice of Informational Webinar for PAR-24-260 "Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) (R24 - Clinical Trial Not Allowed)". See Notice NOT-GM-25-001 .

April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 . August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023.

See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

Funding Opportunity Number (FON) Companion Funding Opportunity Only one application per institution is allowed, as defined in Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose The purpose of the Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) award is to support federally-recognized American Indian/Alaska Native (AI/AN) Tribes, Tribal colleges and universities, Tribal health programs, or Tribal organizations (collectively, eligible federally-recognized Tribes or Tribal Entities) to establish Institutional Review Boards (IRBs) or enhance the capacity of existing Tribal IRBs.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description The Native American Research Centers for Health (NARCH) program was launched in 2000 to promote Tribal health research prioritized and led by eligible AI/AN Tribal entities, with the goal of ultimately improving Tribal health.

The program is one of the federal government’s primary funding sources that support Tribal health research. To enhance the program’s efficacy in meeting its goals, NIGMS completed a comprehensive NARCH program evaluation ( NIGMS Evaluation and Tribal Consultation ) culminating in a formal Tribal Consultation in 2021.

The Tribal Consultation recommended that both research projects and research infrastructure supported under NARCH be primarily conducted by Tribal Nations and communities rather than traditional academic institutions or partners. This Notice of Funding Opportunity (NOFO) is part of the NIGMS response to that recommendation.

The Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) award is aimed at building biomedical research capacity and infrastructure in federally-recognized Tribal communities by expanding their Institutional Review Board (IRB) review and oversight capabilities, reducing reliance on external IRB mechanisms, and supporting Tribal autonomy over research administration.

IRBs are a critical component of research involving human participants, ensuring protection of their rights, welfare, and well-being when involved in research conducted or supported by the U.S. Department of Health and Human Services (review the Office of Human Research Protections and FDA Guidance on IRBs and Protection of Human Subjects in Clinical Trials ).

Program Description and Requirements The TIRBEE program supports federally-recognized Tribes or Tribal Entities (collectively termed Tribal entities, see Section III. 1. Eligible Applicants for details).

Applications will be accepted from both individual and consortia of eligible Tribal entities to: Establish a new Tribal IRB. Enhance an existing Tribal IRB. Applicants may propose activities suitable to establishing or enhancing a Tribal IRB.

Activities may include but are not limited to: Recruiting staff, including consultants and mentors as needed, to establish or enhance a Tribal IRB. Establishing or enhancing policies and procedures for day-to-day IRB operations, billing, and securing data and records management, which may include the use of electronic submission software. Developing communication and information systems (websites, administrative systems, and databases).

Providing equipment and software that are needed to implement protocol review and track ongoing IRB-related activities. Coordinating with other appropriate boards and committees including external IRBs (as needed). Establishing best practices for providing IRB oversight and support throughout the life cycles of research projects involving human subjects.

Providing or supporting competency-based training, coursework, conference attendance, and related activities for IRB administrators and Tribal members to prepare them to serve on IRBs. Enabling staff to gain proficiency in managing IRB processes including, regulatory compliance issues, preparing and evaluating documents, such as Tribal Agreements, research protocols, consent documents, and recruitment materials. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the number of meritorious applications received. Application budgets must not exceed $350,000 in annual direct costs, excluding consortium facilities and administrative (F&A) costs.

For applications that include partner organizations that are not eligible Tribal entities, the requested direct costs of subcontracts to these organizations, combined, must be 25% or less of the application’s overall direct cost budget, excluding consortium F&A. The project period is limited to 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III. Eligibility Information This funding opportunity is limited to the following eligible organizations: The applicant organization must meet one of the following criteria: A federally-recognized AI/AN Tribe, as defined under 25 U.S.C.

1603(14); or A Tribal college or university, a Tribal health program, or a Tribal organization as defined under 25 U.S.C. 1603 (24), (25), and (26), respectively; or A consortium of two or more of those Tribal entities. An application may include foreign components only if one or more federally-recognized Tribes with ancestral catchment areas crossing the U.

S. border will participate in the proposed Tribal Institutional Review Board Establishment and Enhancement (TIRBEE) application. Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants. gov – Applicants must have an active SAM registration in order to complete the Grants. gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role.

Obtaining an eRA Commons account can take up to 2 weeks. Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . The PD/PI or the contact PD/PI of a multi-PI (MPI) application must have a primary appointment with the applicant organization.

Non-contact PDs/PIs' primary appointments may be with the applicant organization or a partner organization that is an eligible Tribal entity. PDs/PIs employed at eligible federally-recognized Tribes or Tribal Entities through special employment arrangements, such as interorganizational personnel agreements among federally-recognized Tribes, are allowable.

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms. 3.

Additional Information on Eligibility Only one application per institution (normally defined by having a unique UEI or NIH IPF number) is allowed. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2. 3.

7. 4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. Mentors are considered as senior/key personnel even if they are not committing any specified measurable effort to the proposed application. Enter “Other Professional” for the “Project Role” field and enter “Mentor” in the “Other Project Role Category” field.

Biographical Sketches for mentors (if applicable) should be provided. All instructions in the How to Apply - Application Guide must be followed. The PD(s)/PI(s), the TIRBEE director (if different), IRB committee chair(s), administrators, and other staff are expected to devote adequate effort to the proposed activities.

Mentors may be supported for up to 1 calendar month effort per year. Consultants' level of effort is not limited but must be well justified. Funding may be requested for the activities described in Section I and for other justified activities.

Allowable costs include but are not limited to: Equipment and software costs that are needed to implement protocol review and track ongoing IRB-related activities. Costs related to communication and information systems (websites, administrative systems, and databases). Expenses related to competency-based training, coursework, conference attendance, and participation in IRB review.

All instructions in the How to Apply - Application Guide must be followed. For applications that include partner organizations that are not eligible Tribal entities, the requested direct costs of subcontracts to these organizations combined must be 25% or less of the application’s overall direct cost budget, excluding consortium F&A. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Specific Aims: The Specific Aims should state clearly the objectives of the application and how meeting them will enable IRB establishment or enhancement.

Research Strategy: The goal of the TIRBEE award is to build the capacity and infrastructure for biomedical research involving human participants in federally-recognized Tribal communities by expanding their Institutional Review Board (IRB) review and oversight capabilities.

Accordingly, the Research Strategy section should outline the objectives and approaches for IRB workforce development and infrastructure enhancement, with the goal of supporting Tribal autonomy over research conducted by, with, and for Tribal communities.

Use the following headings in the Research Strategy: Regulatory Competencies Plan Program Description: Describe the goals of the application (IRB establishment or enhancement) in the context of currently available IRB-related resources and participation in existing IRBs. Applicants should: Describe the organization's current IRB capability and any existing partnerships or collaborations with other organizations.

Provide an overview of the plans to build IRB capacity and accomplish the Specific Aims. Indicate the relationship of the proposed IRB activities to the administrative structure of the applicant organization(s) and Tribal community(ies) it serves.

As applicable, describe the roles and contributions of members of a Tribal consortium (if proposed) and any additional partners, collaborators, consultants, and mentors that will be involved in building IRB capacity. Provide a plan for regular evaluation of IRB-related activities, including milestones to assess progress.

Describe the approach for identifying unanticipated challenges and making improvements based on feedback from TIRBEE staff, IRB participants, researchers, and the community. Also include longer-term measures that will gauge the award's impact on Tribal Health research.

Regulatory Competencies Plan: Describe plans for providing culturally appropriate and federally required education and training to individuals administering and coordinating an IRB and/or those who will participate in IRB review. The Regulatory Competencies Plan should: Describe plans for recruiting Tribal members interested in serving as IRB members and any plans for outreach to receive community input.

Estimate the numbers of IRB members. Provide a list of proposed IRB courses with names of vendors/providers, anticipated certifications resulting from formal coursework, and the modes of delivery (on-line, in-person, etc.).

Describe the development and/or implementation of additional activities and educational modules to enhance and maintain IRB member and staff knowledge of federal, institutional, and Tribal human subjects research regulatory policies. Provide a plan for training and formally onboarding trained Tribal members into a newly established or enhanced Tribal IRB.

Provide a plan to track the progress of individuals for completing required and optional coursework, maintaining any certifications required for their IRB roles, and their participation in IRB reviews. IRB Development Plan: Describe the overall development strategy, operational plan, and organizational structure of the IRB.

The IRB Development Plan should: Describe how the Tribal IRB establishment or enhancement grant will develop the applicant organization's research infrastructure and support Tribal autonomy in the ethical review and oversight of human subjects research.

Describe the desired IRB structure and its workflows for accepting, reviewing, approving, reporting unanticipated problems and non-compliance issues, and overseeing research involving human subjects. Include procedures for handling requests for IRB use and for the adequate and equitable distribution of the IRB resource time and access.

Describe resources to support electronic information handling and secure management of data in accordance with Tribal policies and applicable law. Provide information on the current (if applicable) and estimated future user base for the IRB and a justification for how this future user base is sufficient to merit establishment or enhancement of the IRB.

Describe how IRB leadership and members with appropriate skills and knowledge will be recruited. If establishing a new IRB, include plans for registering with the NIH Office of Human Research Protections and documenting IRB user Federal Wide Assurances. Describe how any proposed mentoring will be provided to relevant staff.

Describe overall feasibility, as well as approaches for dealing with unanticipated challenges, for establishing or enhancing the Tribal IRB during the planning, implementation, and sustainability phases. Sustainability Plan: A primary goal of the TIRBEE Program is to develop and support sustainable IRB research infrastructure. The Sustainability Plan should: Address the need for continued competency training for IRB members and staff.

Outline strategies for providing longer-term support for IRB activities, which might include future plans to implement a fee structure or other revenue model. Include a contingency plan in the event the PD/PI or key administrative staff cannot continue in their roles. Include a plan for filling IRB member and administrative staff vacancies.

Describe contingencies to meet anticipated future IRB needs due to growth of research involving human participants. Describe plans to maintain improvements to IRB capacity beyond TIRBEE funding.

Letters of Support (Required): The application must include a Tribal Letter of Commitment from the applicant organization that is signed by an authorized senior organizational official from the applicant Tribal entity such as a Tribal council leader or president of a Tribal college/university. The letter should describe the organization’s commitment to develop and sustain IRB-related research infrastructure.

Applications that do not include a Tribal Letter of Commitment from a senior organizational official will be withdrawn without review. Additional letters of support as well as Tribal Resolutions and Agreements may be included in the application and should cite the application grant title.

Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide . All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan is not applicable for this NOFO. Appendix: Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the How to Apply - Application Guide . No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration.

NIH and Grants. gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.

gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide . 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7. 9.

1 Selected Items of Cost . 7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide .

Paper applications will not be accepted. Applicants must complete all required registrations before the application due date. Section III.

Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance.

For assistance with application submission, contact the Application Submission Contacts in Section VII. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

See Section III of this NOFO for information on registration requirements. The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide .

See more tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and NIGMS. Applications that are incomplete or non-compliant will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200. 113 and NIH Grants Policy Statement Section 4.

1. 35 . Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected] .

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy Section V. Application Review Information Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular NOFO, note the following: The goal of the TIRBEE award is to build capacity and infrastructure for biomedical research involving human participants in Tribal communities by expanding their Institutional Review Board (IRB) review and oversight capabilities.

The program will support federally-recognized American Indian/Alaska Native (AI/AN) Tribes, Tribal colleges and universities, Tribal health programs, or Tribal organizations (collectively, eligible federally-recognized Tribes or Tribal Entities) to establish Institutional Review Boards (IRBs) or enhance the capacity of existing Tribal IRBs.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the capacity of Tribal communities to conduct research involving human participants, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Do the proposed Tribal IRB activities address the research needs of the communities that it will serve? How will successful completion of the aims bring unique advantages or capabilities to the Tribal Health research communities and advance Tribal autonomy over research with human subjects? How well justified is the need for a new or enhanced Tribal IRB?

Is the size of the pool of potential IRB users sufficient to merit development/enhancement of the IRB? Are the PD(s)/PI(s) and other personnel well suited to their roles in the IRB activities? Do they have appropriate experience and training in overseeing human subjects research regulatory compliance?

If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approaches, governance, plans for conflict resolution, and organizational structure appropriate for the proposed IRB activities? Does the applicant organization have experience overseeing selection and management of subawards, if needed?

If additional partner organizations and/or collaborators are proposed, how well suited is their expertise for their proposed roles? In what ways do their skills and knowledge augment the expertise of the PD(s)/PI(s) and other personnel from the submitting organization?

How strong is the proposed commitment of the applicant organization and partners/collaborators (if applicable) to the goals of the project and to supporting Tribal control of research? Does the application propose refinement, improvement or new organizational concepts, management strategies or other culturally-appropriate approaches in coordinating the proposed IRB activities?

Are the overall strategy, operational plan, and organizational structure of the IRB well-reasoned and appropriate to accomplish the goals of the proposed IRB activities? How robust are plans and milestones for evaluating progress? How appropriate are plans to address unanticipated challenges and to improve the proposed activities based on participant feedback?

Does the proposed strategy adequately establish feasibility associated with its activities? How suitable are plans to sustain improvements to Tribal IRB capacity beyond TIRBEE funding? How appropriate are the plans to encourage and recruit Tribal members to participate in the proposed training and then serve as IRB members?

How suitable are plans to promote a culturally appropriate research environment and respect for