Part 1. Overview Information

Key Dates

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.

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.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. 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.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
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

Background

American Indian/Alaska Native (AI/AN) populations have long experienced health disparities compared with other U.S. populations. Multiple factors, including limited access to health care, distrust of health-related research due to trauma inflicted on AI/AN communities by past unethical research practices, and limited opportunities for AI/AN Tribes to lead health research involving their communities have contributed to these disparities. The Native American Research Centers for Health (NARCH) program was launched in 2000 to help reduce the distrust of health research by AI/AN communities and promote AI/AN health research prioritized and led by eligible AI/AN Tribal entities, with the goal of ultimately improving AI/AN health. The program is one of the federal government’s primary funding sources that support AI/AN 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 AI/AN 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

Applicant Organizations

The TIRBEE program supports federally recognized AI/AN Tribes, Tribal colleges and universities, Tribal health programs, or Tribal organizations (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.

Activities Supported

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

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

1. Eligible Applicants

This funding opportunity is limited to the following eligible organizations:

Local Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

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 AI/AN 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

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.

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 Tribal entities through special employment arrangements, such as interorganizational personnel agreements among federally recognized AI/AN Tribes, are allowable.

2. Cost Sharing

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

Number of Applications

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.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

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.

SF424(R&R) Cover

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. 

R&R Budget

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. 

R&R Subaward Budget

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.

PHS 398 Research Plan

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 AI/AN 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:

• Program Description
• Regulatory Competencies Plan
• IRB development Plan 
• Sustainability 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.

Other Plan(s): 

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.

Delayed Onset Study

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.

6. Funding Restrictions

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.

Important reminders:

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

1. Criteria

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 AI/AN 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 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 AI/AN 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.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute for General Medical Sciences (NIGMS), in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Portfolio breadth, including geographic and Tribal distribution.
• Size of the userbase of the proposed IRB.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the TIRBEE program, employing the representative measures identified below. In assessing the effectiveness of research resource investments, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants’ subsequent outcomes, respecting Tribal sovereignty and data ownership.

The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

Characteristics of the applicant and awardee pool for the program, such as:

• Organization types
• Types and extents of resources provided

Measures of resource development and utilization, such as:

• Time to first reviews for newly established IRBs.
• Numbers of IRB reviews conducted per year.
• Number and retention of IRB staff and committee members trained and mentored.
• Number of new IRBs registered with the Office of Human Research Protections.
• Number of Federal Wide Assurances affiliated with IRBs
• Evidence of progress towards IRB sustainability.

Indicators of research community outreach and engagement, such as:

• Increase in use of Tribal IRBs relative to external IRBs.
• Evidence of activities to publicize services provided.
• Growth in the research community engaging with Tribal IRBs.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Crystal Richards, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Email: [email protected] 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.