Part 1. Overview Information

Key Dates

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the 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.
   
   



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. 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. Funding Opportunity Description

Authorized by the U.S. Congress in 1993, the National Institutes of Health (NIH) established the Institutional Development Award (IDeA) program to build biomedical research capacity in the 23 U.S. states and Puerto Rico that had historically low NIH grant funding success rates. IDeA funding programs collectively support biomedical research in basic, clinical, behavioral, and translational science in IDeA-eligible states by developing faculty investigators, providing research opportunities to students, and enhancing research infrastructure.

A key IDeA component is the Centers of Biomedical Research Excellence (COBRE) program that supports the establishment and development of innovative biomedical research centers of excellence through awards for three sequential five-year phases. A Phase 1 award aims to enhance an institution's capacity in one area of biomedical research by developing a critical mass of investigators who can compete effectively for independent funding in the scientific area supported by the Center and improving research infrastructure. The COBRE Phase 2 awards are intended to strengthen successful Phase 1 Centers through continued development of investigators and further improvements to research infrastructure. By the end of the Phase 2 award period, it is expected that there will be a critical mass of investigators in the COBRE research area at the institution who are able to compete successfully for independent research funding. Phase 3 awards provide resources to transition COBREs to self-sustaining research programs.

COBRE Phase 2 Program Description and Requirements

To submit a Phase 2 application in response to this FOA, the applicant institution must have an active COBRE Phase 1 award and have established the necessary infrastructure to support research in the area of the Center. It is essential for a Phase 2 application to demonstrate how Phase 1 support has enabled Research Project Leaders to successfully publish their research work and compete for independent research grant funding, and how Research Cores established during Phase 1 have enabled scientific development at the Center, in order to justify another five years of support for continued capacity building in the research area of the Center at the institution. Applications should also propose strategies to increase the user base of Research Cores in anticipation of the need for Cores to become self-sustaining when COBRE funding ends.

Overall Plan (required): A COBRE Phase 2 award supports the strengthening of a successful multi-component Phase 1 center of excellence in an area of biomedical research that aligns with the applicant institution’s strategic priorities for growing its research capacity. The COBRE Phase 2 program seeks to continue the development of a critical mass of investigators who can compete effectively for independent, external research funding. The Phase 2 award will provide research support and mentoring to faculty investigators as well as enhancements of the institution’s research infrastructure to facilitate research in the Center’s scientific area. Applicant institutions should demonstrate their continued commitment to the COBRE program goals by investing in the recruitment and support of the Center’s investigators and the long-term sustainability of the research infrastructure. An established investigator with scientific expertise in the research area of the Center as well as mentoring and administrative experience is expected to lead the Center as the Program Director/Principal Investigator (PD/PI) of the award. An Advisory Committee (AC) comprised of institutional leadership and external experts in the scientific area is required to provide advice on scientific administrative matters critical to the success of the Center.

Required components of a Phase 2 Center include an Administrative Core and 2-5 scientifically independent Research Projects. Research Cores required for the proposed research may also be included. All proposed components must be integral to the goals of the Center and are expected to interact with each other and with relevant existing programs at the institution to foster a collaborative research environment.

Administrative Core (required): The Administrative Core implements the Center’s overall plan, coordinates the Research Projects, Cores, AC, and mentoring activities, and carries out all responsibilities required of the COBRE award. These include:

• preparing accurate and timely progress reports,
• ensuring all Center activities are compliant with federal regulations,
• managing the Center’s budget and financial reporting,
• organizing Center-wide scientific and career development activities such as seminar series, workshops, and retreats, and
• conducting annual performance evaluations of the Center.

The Administrative Core also administers a required Pilot Projects Program (PPP) to support faculty investigators to test hypotheses and develop ideas that may strengthen and expand the Center’s research area.

Research Projects (required): A minimum of two and a maximum of five Research Projects related to the Center’s research area must be proposed. The Research Projects in Phase 2 should solidify the Center’s strength in its scientific area through studying topics related to, but different from those funded in Phase 1. Each Research Project should propose innovative science that has the potential to advance the field and jumpstart the research program of its Research Project Leader (RPL). RPLs must qualify either as NIH Early Stage Investigator (ESI) or as a New Investigator (NI), must hold faculty appointments (or equivalent at research institutes), and lead their own research programs (see Section III. Eligibility Information for additional details). A senior faculty member is assigned to each RPL as a mentor to guide the RPL's research and professional development. Each Research Project is expected to be supported for 2-3 years. The research proposed should be appropriate for the RPL’s research team to complete within this time frame. RPL graduation from COBRE support with research publications and independent research grant funding is a key measure of a Center’s success. Upon graduation of an RPL, a replacement RPL should be selected to fill the vacancy. Applications proposing ESIs in the RPL role are strongly encouraged.

Research Core(s) (optional): A Phase 2 Center may support enhancements to a Research Core(s) established in Phase 1. New Research Core(s) may be proposed provided they are essential to support proposed research and do not duplicate existing services or facilities at the applicant institution. Consolidation of existing Cores for technology advancement and/or administrative efficiency and the sharing of research facilities supported by other IDeA programs (e.g., INBRE, IDeA-CTR, and other COBREs) is strongly encouraged.

NIH/NIGMS Plan for Enhancing Diverse Perspectives (PEDP) (required): NIGMS recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, NIGMS encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Transdisciplinary research projects and collaborations
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

In the required attachment (see Section IV) to address the NIH/NIGMS PEDP, the examples listed above may be followed should they be appropriate for the goals, structures, and requirements specific to the COBRE program.

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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 FOA.

Section III. Eligibility Information

1. Eligible Applicants

Only COBRE Phase 1 Centers supported by an active award, including those in a no-cost-extension, are eligible to apply.

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 not allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 registration; 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 his/her 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 SF424 (R&R) Application Guide.

The PD(s)/PI(s) is expected to be an established biomedical research scientist with the mentoring and administrative experience necessary to lead the Center. The PD(s)/PI(s) may be the PD(s)/PI(s) of the COBRE Phase 1 award or be a replacement PD(s)/PI(s) appointed by the institution.

At the time of submission, the COBRE PD/PI’s primary appointment must be at the applicant institution. The PD/PI must also hold, as PD/PI, at least one active, peer-reviewed, and externally funded research grant in the scientific area of the COBRE that is awarded to the applicant institution. If a COBRE PD/PI’s qualifying research grant is a multiple PD/PI award to a different institution, the applicant institution must receive funds via a subcontract supporting the COBRE PD/PI's research.

For multiple PD/PI COBRE applications, all non-contact PD(s)/PI(s) must also have at least one active, peer-reviewed, and externally funded research grant in the scientific area of the COBRE that is awarded to the institution where they hold a primary appointment.

A PD/PI may not simultaneously lead more than one IDeA (INBRE, IDeA-CTR, or other COBRE) program award. Previous COBRE PD(s)/PI(s) of different COBRE Centers, except those who served in that capacity on an interim basis, are not eligible to lead a COBRE Phase 2 application. All investigators who intend to apply as PD(s)/PI(s) are encouraged to consult with the Scientific/Research Contact listed in Section VII prior to preparing an application.

Eligible Individuals (Research Project Leaders)

RPLs must qualify as either NIH Early Stage Investigators (ESIs) or as New Investigators (NIs). They must also hold independent multi-year faculty appointments (or equivalent at research institutes) and be leading their own research programs. More than half the RPLs must hold primary appointments at the applicant institution. An RPL with a primary appointment at another IDeA institution may be proposed, provided that institution, through subcontracts, holds four or fewer COBRE Research Projects and/or Cores from active Phase 1 and Phase 2 COBREs awarded to other institutions; note that subcontracts for Research Cores from Phase 3 COBREs are not included in this calculation. An investigator cannot receive more than five years of support as a COBRE RPL in total, inclusive of any RPL support from another COBRE award. A COBRE RPL cannot receive simultaneous research support as a COBRE Pilot Project Leader (PPL). Furthermore, a COBRE RPL or PPL cannot receive simultaneous research support as a project lead from any other IDeA parent award (e.g., COBRE, INBRE, IDeA-CTR), but may be eligible to serve as a project lead of a supplement to an IDeA award.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the 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 SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

Overall Component

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: The application must include the following attachment.

Plan for Enhancing Diverse Perspectives (PEDP) (1-page maximum): All applications must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations
• Description of any planned partnerships that may enhance geographic and regional diversity
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce
• Proposed monitoring activities to identify and measure PEDP progress benchmarks
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s)
• Publication plan that enumerates planned manuscripts and proposed lead authorship
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds

The examples listed above may be followed should they be appropriate for the goals, structures, and requirements specific to the COBRE program.

Please name the attachment "Plan for Enhancing Diverse Perspectives (PEDP)".

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

Biographical Sketch: Each PD/PI should include a description of their mentoring and administrative experience in the Personal Statement of the Biographical sketch.

Current and Pending Support Attachment: Include an attachment titled Current and Pending Support with the following information for each PD/PI’s current and pending research grants, from both federal and non-federal sources, which is critical information for determining the PD/PI's eligibility and suitability to lead the Center:

• Project Number
• Name of Recipient Institution
• Source of Support and Title of the Project (or Subproject)
• Role on the Project and Level of Effort (in calendar-months)
• Dates of Approved/Proposed Project
• Total Costs to the PD/PI’s laboratory for the period of performance
• Project Goal

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

Specific Aims: Provide Specific Aims for the Center.

Research Strategy: This section must include the following elements:

A. Program Accomplishments

The purpose of this FOA is to allow institutions holding successful COBRE Phase 1 grants to compete for continuation of support to advance the Center to Phase 2. Applicants must provide evidence that prior support has enabled the Center to achieve specific benchmarks in Phase 1 in the following areas (use tabular format where appropriate):

• Investigators and funding:
  • List of RPLs supported by the Phase 1 award and career advancements they achieved resulting from COBRE support
  • List of RPLs supported by the Phase 1 award who have successfully completed their projects, including updates of their current funding and employment status
  • Number of research grants by RPLs submitted to, and awarded by, NIH or other agencies or foundations
  • List of investigators recruited to the institution in the Center’s research area during the Phase 1 award
  • If a Pilot Projects Program has been in place during Phase 1, provide a list of PPLs supported by the Phase 1 award, their current employment status, and any grants submitted or awarded that are attributable to the pilot support
• Research productivity:
  • Number of scientific publications in peer-reviewed journals from Research Projects and Pilot Projects carried out with the support of COBRE
  • Patents filed and intellectual property generated
• Development and use of research infrastructure:
  • Core facilities established
  • Equipment procured
  • Description of current user base of core facilities
  • Training provided to users

B. Organization and Management Plan

The Organization and Management Plan for the Center should clearly convey a strategy for a successful Phase 2 Center that builds upon the Phase 1 efforts. This should include effective use of the available funding, configuration of the Center and its cores, and approaches for selecting research projects and supporting investigators. Important elements to include are:

• The goals of the Phase 2 Center
• A description of the Center’s components and how each contributes to the Center’s goals and will interact with one another
• A description of how the Phase 2 Research Projects will build on the institutional research capacity in the scientific area of the Center established during Phase 1.
• A description of how the Research Cores complement and interface with existing resources at the institution without being duplicative; include equipment, instrumentation, and cores supported by current or prior IDeA (COBRE, INBRE, or IDeA-CTR) awards.
• If the COBRE focuses on rural health and/or community-engaged research, detailed plans that outline stakeholder input, community outreach, and evaluation strategies for outcomes must be provided.
• Justification of continued support via a second five-year phase for building on the success achieved during Phase 1 and the plans for Phase 2.

C. Plan for an Advisory Committee

An Advisory Committee (AC) composed of three external, nationally recognized scientists with expertise directly relevant to the scientific area of the Center, one senior institutional official (e.g., Dean, Vice-President for Research), and one senior faculty member appointed by the senior institutional official must be assembled to advise the PD(s)/PI(s). AC members who previously served as external advisors during Phase 1 may be appointed as Phase 2 AC members. An AC member may not serve as an RPL mentor, core director/advisor, or hold any other position in the Center.

Responsibilities of the AC include but are not limited to, reviewing the annual Center evaluation provided by its Administrative Core, making recommendations to the PD(s)/PI(s) to improve the Center's performance, and providing feedback to RPLs, their mentors, and the PD(s)/PI(s) regarding the RPLs' progress in research and career development.

If an RPL is delayed in meeting milestones, the AC should provide advice to the PD(s)/PI(s) on ways to address concerns. The AC also assesses proposals for replacement Research Projects and Pilot Projects when the need arises. The PD(s)/PI(s) must include the AC’s recommendations when requesting NIGMS’s approval to appoint replacement RPLs and new PPLs. The AC should meet at least twice per year.

Plans for the AC should detail:

• Name, position, scientific expertise, and qualifications of external AC members who are continuing their Phase 1 advisory roles. For new external AC members, only provide a description of the qualities and scientific expertise desired without naming specific individuals or contacting them prior to receiving the Notice of Award (NoA) for the application.
• The names and positions of the senior official and senior faculty member from the applicant institution.
• A description of how the AC will function.
• Additional responsibilities, if any, that are proposed for the AC.

D. Mentoring Plan

The Center is required to assign a mentor to each RPL. The mentor should be an established investigator who is able to provide scientific advice and career guidance to the RPL. If a suitable mentor at the applicant institution is not available, it is acceptable to enlist an appropriate mentor from another institution, including those located in non-IDeA states. The Mentoring Plan should:

• Provide a description of how mentors are selected, including their qualifications to provide scientific advice and career development guidance to the RPLs, how mentors will be trained in mentoring best practices, and how mentor performance will be assessed.
• Describe how mentoring will be conducted, including required activities.
• Include mentoring strategies for RPLs who fall short of meeting established milestones.

Letters of Support: A letter of support from a senior institutional official (e.g., President or Dean) must be included, outlining the institution’s strategic plan and how the COBRE aligns with the institution’s strategic priorities. The letter must also provide:

• A description of the size of the biomedical research faculty at the institution and the total external biomedical research and infrastructure grant support of the institution.
• A description of the commitment of resources to sustain the COBRE throughout the period of funding, including support for hiring new faculty members, retaining faculty, and maintaining infrastructure developed by the Center beyond the period of COBRE support.

If the application proposes subcontracts to another institution for RPLs and/or Research Cores, a letter of support with similar content from a senior official of the participating institution must be provided.

Applications that do not include this Letter of Institutional Support will be considered incomplete and the application will be withdrawn without review.

Additional letters demonstrating state-level, regional, and/or local support for the Center may be included in this section only if they address a substantive and specific need.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the SF424 (R&R) Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

A minimum level of effort (LOE) of three person-months is required of each PD/PI to devote to career guidance and administrative oversight of the Center. A maximum of six person-months of annual salary support may be requested collectively for all PDs/PIs. A PD/PI may not use COBRE funds to supplement research activities for their laboratory or research team and is not eligible for research project support from this COBRE or any other COBRE, INBRE, or IDeA-CTR award.

PEDP implementation costs: Budget request may include allowable costs associated with PEDP implementation, as outlined in the Grants Policy Statement.

Funds to compensate external members of the AC as consultants via a fee-for-service arrangement should be requested in the Administrative Core budget. Internal AC members may not receive compensation from the COBRE.

Funds to compensate mentors for up to one person-month of effort should be requested in the Administrative Core budget and not in the budget sections of individual Research Projects. Mentors from non-IDeA states can be compensated as consultants or via a fee-for-service arrangement.

Direct costs of up to $400,000 annually may be requested to support the required Pilot Projects Program. Each individual Pilot Project may have a duration of up to one year with a maximum budget of $100,000 in direct costs. An investigator may receive support for no more than two one-year Pilot Projects during Phase 2. The budget should only include a placeholder for the Pilot Project Program as prior approval is required before a Pilot Project can begin; see Section VI. Post-Award Program Requirements.

Funds may be used to assist the institution's recruitment of additional faculty who strengthen the proposed program. These funds are limited to $400,000 in annual direct costs and may be used to recruit investigators at any career stage in the Center's research area. These funds may be used for salary, supplies, and/or equipment costs.

Funds may be used to develop or enhance appropriate community-engaged research, including efforts to develop a coalition of community and academic stakeholders who can provide input on evaluation strategies and dissemination of the results.

Funds cannot be used by or for collaborators at institutions in non-IDeA states or at foreign sites. However, funds may be used in other IDeA and non-IDeA states and foreign sites for fee-for-service activities, such as learning new techniques, sample and data analysis, attending workshops, or obtaining scientific advising/consulting/mentoring (as described above).

The PD(s)/PI(s) of the Centers funded through this FOA are expected to attend the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meeting.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The important elements for this section include the following:

• A clear description of the necessary administrative, fiscal, and scientific aspects of the Phase 2 Center.
• A description of the research and career development goals and capabilities of the Center, including plans to offer Center-wide scientific and career development activities such as seminar series, workshops, and retreats.
• An evaluation plan with clear timelines and milestones to annually monitor and evaluate the performance of all components of the Center and the progress of the RPLs it supports. Strategies to identify and remedy deficiencies such as poor performance and lack of progress should be described and procedures to implement the AC's recommendations should be included.
• An RPL Development Plan addressing the development and transition of RPLs to independent research funding. This Plan should include details of how the Center, together with the institution, will assist its COBRE-supported investigators to transition to competitive grant support through applications submitted to relevant NIH Institutes and Centers or to other appropriate agencies or organizations. The Plan should also describe strategies for the continued engagement of these investigators in the COBRE after their RPL support has ended. The Plan must also include both formative and summative evaluation strategies with specific milestones, including, but not limited to, acquisition of independent external, peer-reviewed research grant support and publications in peer-reviewed journals.
• A description of how mentors will be oriented or trained, and how their performance will be assessed.
• A description of the process for identifying replacement Research Projects and RPLs, the structure and requirements of replacement Research Project applications, and how review will be conducted by the AC.
• A plan for a Pilot Projects Program must be included. The Pilot Projects Program should encourage the exploration of novel ideas, concepts, and approaches in the scientific area of the COBRE. The Pilot Projects Program should build on the Center’s scientific strengths and may extend to research fields that are related to, but beyond the Center's research area. The plan for the Pilot Projects Program must include the following:
  • An outline of the administrative structure and objectives for the Pilot Projects Program during Phase 2, highlighting changes from Phase 1, if applicable
  • Details on the process for proposal solicitation, review, and selection
  • Career and research mentoring activities for Pilot Project Leaders (PPLs)

Research plans for individual Pilot Projects should not be included in the application.

Letters of Support: Not allowed. Institutional Letters of Support, including support for the Administrative Core, should be included in the Overall Component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Do not complete. Human subjects research is not allowed in the Administrative Core.

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 SF424 (R&R) Application Guide must be followed.

Research Core

When preparing your application, use Component Type Core .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Director and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons who are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Director(s) of a Research Core facility must be experienced personnel with the requisite stature, knowledge, authority, leadership, administrative skills and capabilities to direct the resource. The Core Director will lead a team that provides services to: (1) develop or improve plans for standard operating procedures governing the utilization and management of core expertise and resources; (2) develop or improve plans for disseminating information, training, and serving as subject matter experts to investigators; (3) maintain state-of-the-art technologies and knowledge capabilities; and (4) recommend to the COBRE PD(s)/PI(s) any updates and/or replacement of equipment.

Budget (Research Core)

Budget forms appropriate for the specific component will be included in the application package.

Funds may be requested to establish Research Core facilities and/or to use, modify, or expand existing resources that are necessary for accomplishing the scientific goals of the Center. In addition to personnel and supply costs, the acquisition of new equipment and modernization of instrumentation may be proposed. Alteration and Renovation (A&R) of core facilities cannot be proposed, nor can funds be used to support A&R.

Core facilities should have a detailed budget for the entire proposed project period (five years).

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed (but not required) in the Research Core component.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The important elements to include in this section are:

• A description of the technology, instrumentation, and/or services the Core will provide. If the Core requests instruments and/or equipment or involves modification and/or expansion of an existing core facility, include a description of the institution's current infrastructure and services offered, and justify the proposed changes/additions.
• A description of how the Core will impact the development of the Center and how the core will serve the scientific needs of individual Research Projects and enhance research infrastructure at the institution.
• A description of the Core's userbase that was established in Phase 1 and any plans to expand it.
• A description and justification for any proposed new Cores, including how new Core facilities will benefit investigators and improve the research infrastructure of the institution and a description of other related research resources that are already available at the institution.
• A description of the business plan for operation of the Core, including prioritization of service requests, user fee structure, and maintenance costs.

A Research Core should be made available to other investigators at the institution as well as those from other IDeA-state institutions. Cores that duplicate services already available at the applicant institution are not allowed. Utilization, modification, or expansion of existing Core resources supported by institutional funds or other IDeA programs to accomplish the goals of proposed COBRE research is strongly encouraged.

Letters of Support: A letter from an institutional leader demonstrating commitment to support and maintain the proposed facilities can be included but should not duplicate letters included elsewhere in the application. Letters from leaders of any established Cores that will be leveraged for the COBRE research should also be included.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 a Delayed Onset Study record. If a human subjects protocol(s) is used in a single Project or Core of the Center, the study record(s) must be included in the component where the human subjects research is being performed. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

Research Project

When preparing your application, use Component Type Project

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Research Project Leader and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons who are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Additional instructions:

• The RPL's mentor(s) should be listed as key personnel in this component.
• Each RPL should describe in the Personal Statement of the Biographical Sketch their current and previous peer-reviewed research support.

RPL Eligibility: At the time of submission, an RPL must qualify either as an NIH Early Stage Investigator (ESI) or as a New Investigator (NI), hold a multi-year faculty appointment (or equivalent at research institutes), and be leading their own independent research program. See Section III. Eligibility Information for details.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Applicants should propose a five-year budget for each Research Project. The proposed five-year budget should include up to 3 years total support for each RPL with future years designated for replacement RPLs.

RPLs must make a minimum level of effort commitment of six person-months annually.

Salary support for postdoctoral research associates, graduate and undergraduate research assistants, and other research assistants may be requested with justification for the needs of the Research Project.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed (but not required) for each component.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The Research Strategy should describe how the proposed Center and the Research Project (RP) will advance the independent career of the RPL, rather than provide a detailed experimental plan for the RP. The RPL should describe how the COBRE support will impact long-term goals for their research program and how the Center will help advance the RPL's career goals. The roles of Research Cores in helping the RPL to accomplish the project's Specific Aims should be described. The RPL should describe how the mentoring provided by the Center will be used and how it will benefit their career goals.

The Research Strategy should delineate the scientific questions to be answered and/or the design principles of the project but does not need to provide extensive experimental details, as it is expected these will be developed and evolve over time with appropriate mentorship provided by the Center. The Research Strategy should include a critical assessment of existing knowledge and approaches relevant to the project and provide possible strategies to address the key goals/questions proposed, while emphasizing how the anticipated outcomes of the RP will advance the field and concisely stating the importance of the proposed research. The research proposed should be appropriate for the RPL’s research team to complete within the time frame of 2-3 years. Projects that carefully address a small but significant part of a bigger question are encouraged. These projects are expected to develop and evolve, benefiting from mentorship provided by the Center. Preliminary data are not required but, if present, will be evaluated. An RPL continuing from Phase 1 is expected to describe progress commensurate with the duration of the Phase 1 funding.

If the RP involves human subjects and/or NIH-defined clinical trials, strong justification for the Project’s scientific goals and research strategy proposed must be provided; justification for the inclusion or exclusion of individuals on the basis of sex/gender, race, ethnicity, and age in patient enrollment, when applicable, must be provided, and plans to ensure protection of human subjects from research risks and patient data safety must be included. Given the relatively short award duration of 2-3 years for an RP, it is acceptable that the Project propose a smaller scale clinical trial to collect preliminary data for a future, larger scale clinical trials. Justification should be provided on how the RP will contribute to these future studies. An RP may address one or more aspects or steps of a clinical trial instead of a complete trial. Similarly, an RPL may also lead part of a trial directed by other investigator(s) as their RP; in such cases, a letter from the lead investigator should be provided. Furthermore, for RPs involving human subjects and/or NIH-defined clinical trials, a mentor with extensive experience in clinical research must be assigned to the RPL.

If the RP involves community-engaged research, the RPL should describe plans to engage appropriate community and academic stakeholders to provide input.

Letters of Support: Each RPL must provide a Letter of Institutional Support from an institutional leader such as a Department Head, Dean, or Provost from the RPL's home institution. The letter must demonstrate a clear commitment to support a multi-year faculty-level appointment for the proposed RPL independent of the outcome of the COBRE grant application. Examples of strong institutional commitment include a start-up package provided by the institution, salary support, and/or independent research space within the institution. Applications that do not include a Letter of Institutional Support for each RPL will be considered incomplete and the application will be withdrawn without review.

Additional letters demonstrating support to the proposed Research Project and/or the RPL may be included in this section if they do not duplicate letters included elsewhere in the application.

Resource Sharing Plan: Applicants are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Research Project)

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 a Delayed Onset Study record. If a human subjects protocol(s) is used in a single Research Project or Core of the Center, the study record(s) must be included in the component where the human subjects research is being performed. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. 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. Overview Information 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) using ASSIST or other electronic submission systems. 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 Policy on Late Application Submission.

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 SF424 (R&R) 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 SF424 (R&R) 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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

In addition to the materials listed in the Post Submission policy, updates on funding obtained (not applications submitted) by RPLs or PPLs who participated in Phase 1 of the COBRE Center will also be accepted.

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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center 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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Is the Center aligned with the institution's strategic priorities in developing research capacity? Does the institution justify the continuation of the Center? Does the Center address and important problem or a critical barrier in the field? Do the Specific Aims of the Center outline how the proposed work will advance knowledge, technical capabilities and/or clinical practice in the field of research? Will plans for Phase 2 significantly strengthen the Center that was established during Phase 1?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the Center?

Program Accomplishments: Has the Center brought together a cadre of investigators working in the Center's research area? Has the institution invested in the recruitment of investigators working in the scientific area of the Center? Have recruitment efforts increased the biomedical research capacity of the institution? Has the Center achieved specific benchmarks proposed for Phase 1, which for RPLs include career progression, attainment of independent research funding, and publishing their results in peer-reviewed journals? Is there evidence that the competitiveness of these investigators for NIH or other external peer-reviewed research grant support has been enhanced through COBRE support?

Investigator(s)

Does the PD(s)/PI(s) have the appropriate background to lead, develop, and direct the COBRE to continue enhancing research capacity at the institution in a biomedical research area? Has the PD(s)/PI(s) shown effective leadership in directing and managing the Phase 1 COBRE, if applicable? Has the PD(s)/PI(s) provided evidence of successfully mentoring and guiding early career investigators? Does the PD(s)/PI(s) have a record of sustained leadership of a productive research group in the scientific area of the Center?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the Center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Does the Overall Plan for the Center support the need for continuation of funding into Phase 2?

Do the proposed Research Projects contribute adequately to the overall enhancement of biomedical research capacity in the Center’s scientific area at the applicant institution? Do the proposed Research Projects support the scientific goals of the Center and the strategic priorities of the institution?

Are plans for the recruitment of new investigators consistent with the goals of strengthening biomedical research capacity in the scientific area of the Center? Does the application provide viable plans for maintaining a pipeline of RPL candidates in the research field of the Center?

Are qualified established investigators assigned as mentors to RPLs? Are the mentors adequately prepared/trained to provide advice and guidance to RPLs? Does the Mentoring Plan include clear strategies to guide the RPLs? Is mentoring performance assessed and evaluated?

Is the proposed composition of the Advisory Committee appropriate? Is the proposed scientific and administrative expertise of AC members adequate to assess the research and capacity building progress of the Center and to offer advice to the PD(s)/PI(s) on scientific and career development matters, including the assessment of new Research Projects and RPLs to the PD(s)/PI(s)? Is the role of the AC in these matters adequately described?

Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Is the institutional support, including equipment and other physical resources provided to the investigators, adequate for the proposed Center? Does the application demonstrate the institutional commitment to support the goal of strengthening the biomedical research capacity in the scientific area of the Center?

Does the applicant institution demonstrate a commitment to recruit and support faculty investigators in the scientific area of the Center? Do the environment and resources available at the institution meet the needs of the Research Cores, RPLs, and PPLs? Has prior COBRE support improved facilities or made available new and collaborative resources (e.g., laboratory facilities, patient populations, laboratory space and personnel)?

To what extent is the Plan for Enhancing Diverse Perspectives compatible with the institutional environment, the institution’s strategic priorities for growing its research capacity, and its potential contributions to the success of the Center?

Review Criteria for Cores

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Core to exert a sustained impact on the research field(s) involved, in consideration of the following review criteria and additional review criteria.

Administrative Core

Does the Organizational and Management Plan for the Administrative Core provide confidence that the Overall goals of the Center will be fully implemented?

Is there a well-integrated plan to manage and coordinate the Cores, Projects, Advisory Committee, and Mentors to achieve the Center's goals?

Is there a clear plan to carry out all responsibilities required of the COBRE award including, but not limited to, preparing accurate and timely progress reports, ensuring all Center activities are in compliance with federal regulations, managing the Center's budget and financial reporting, and organizing Center-wide scientific and career development activities?

Are appropriate formative and summative strategies described for conducting annual evaluations of the Center? Are there suitable plans for implementing recommendations of the AC?

Does the Administrative Core provide a clear RPL Development Plan that helps RPLs to successfully transition to independent research funding? Does the Plan provide specific milestones for the acquisition of independent funding by the investigators and subsequent graduation from COBRE support?

Are appropriate plans in place to manage mentor training and evaluation?

Is the process of selecting candidate investigators and reviewing replacement Research Projects by the AC structured appropriately?

Is the Pilot Projects Program aligned with the scientific goals of the Center? Are the plans for solicitation and prioritization of proposals suitable to attract investigators that broaden the expertise in the scientific area of the Center and encourage the development of novel concepts, approaches, and methodologies? Do the plans articulate adequate procedures for the review of proposals? Are suitable processes proposed to evaluate the progress and success of the Pilot Projects? If a Pilot Projects Program has been in place during Phase 1, have prior Pilot Project Leaders achieved success at publishing their results and generating data that enable them to secure peer-reviewed independent funding?

Research Cores

Is the request to support the Research Core well justified? Does the Core provide suitable scientific support to the proposed Research Projects? If a Core has been supported by the Phase 1 COBRE award, did it develop a successful business plan and establish a strong user base? Does the Core Director have the expertise to provide the necessary oversight to administer the maintenance and growth of existing core resources and laboratory facilities to carry out the scientific objectives outlined in the application? Has the Core Director and/or the PD(s)/PI(s) (as appropriate) obtained sufficient institutional commitments to ensure that the resources and facilities required to sustain and enhance the Core will be available?

Review Criteria for Individual Research Projects

For each Research Project, reviewers will provide an overall impact score to reflect their assessment of the merits of the proposed Research, the RPL, and the likelihood that the Project along with the mentoring provided by the Center will advance the RPL’s scientific career, in consideration of the following review criteria and the additional review criteria.

• Does the RPL have the necessary background and scientific expertise to lead the proposed Research Project? Does the RPL demonstrate the potential to develop into an investigator who can compete successfully for independent grant support?
• Does the Research Project address an important problem or a critical barrier to progress in the field? Is there strong evidence that the proposed research topic will permit the RPL to establish a unique place in the field of research? Does the Research Project have strong potential to improve scientific knowledge, technical capability, and/or clinical practice? Is the proposed research innovative in one or more aspects: does it challenge or seek to shift/refine current research or clinical practice paradigms, make use of novel theoretical concepts, approaches, methodologies, instrumentation, or interventions?
• Is the overall research strategy outlined well-reasoned and appropriate to accomplish the goals? Is the prior research that serves as the key support for the proposed Research Project rigorous? If included, do the preliminary data support the Research Project’s hypothesis and/or objectives? Are potential problems, alternative strategies, and benchmarks for success presented? Are plans to address relevant biological variables, such as sex and age, for studies in vertebrate animals or human subjects adequate?
• Will the Research Project adequately develop important preliminary data and the scientific communication and lab management skills of the RPL that are important to leading a long-term, independently funded research program?
• Does the assigned mentor(s) have the scientific expertise and experience to provide appropriate career advice to the RPL? Is the mentoring specifically tailored to the RPL and considered effective? Is the institutional support for the RPL sufficient for completion of the Research Project? Will the Research Project benefit from Research Cores?
• If the Research Project involves human subjects and/or NIH-defined clinical research, are the plans to address: 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of individuals across the lifespan (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
• If the Research Project involves community-engaged research, are there clear and detailed plans for developing a coalition of community and academic stakeholders who can provide input on evaluation strategies and the dissemination of the results?

In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and interventions that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

• Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?
• With regard to the proposed leadership for the project, do the RPL and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multi-center trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
• Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
• Does the application adequately address the following, if applicable:
  • Study Design
    • Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative, and relevant to the hypothesis being tested? Is the prior preclinical and/or clinical research that serves as the key support for the proposed project rigorous? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
    • Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
    • Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
  • Data Management and Statistical Analysis
    • Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
    • If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the overall application, core(s) and projects 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.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

As applicable for the overall application, core(s), and projects 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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIGMS, in accordance with NIH peer review policy and procedures, 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. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. Applications will compete for available funds with all other recommended applications. 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
• Portfolio balance
• Geographical and institutional distribution
• Relevance of the proposed Center to program priorities, including:
  • Inclusion of Early Stage Investigators as Research Project Leaders
  • Scientific breadth of the Center and its relationship to institutional strategic goals
  • Need for continued development of investigators in the Center's scientific area

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 VI. Award Administration Information

1. Award Notices

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Post-Award Program Requirements

Administrative Core

PD(s)/PI(s) of COBRE Centers funded through this FOA are expected to attend the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meeting.

Research Projects

RPLs are named as key personnel on the Notice of Award.

Prior approval by NIGMS is required for adding or removing RPLs from Research Projects. See "Prior Approval of Pilot and Replacement Research Projects" below for documents that must be submitted to NIGMS.

When an RPL leaves the COBRE, the grantee must notify NIGMS immediately and not wait until a replacement RPL has been identified. The new COBRE Research Project that replaces the completed or terminated project must be reviewed by the PD(s)/PI(s) and the AC. The PD(s)/PI(s) must communicate the AC recommendation to NIGMS for its programmatic and administrative review.

An RPL must submit an independent investigator-initiated, peer-reviewed research project grant (RPG) application by the end of two years of COBRE support. It is expected that an RPL will be supported by the COBRE for three years and then move to independent research support. COBRE Research Project support beyond three years may be provided in circumstances where the COBRE PD/PI and the AC have carefully evaluated the Project’s progress and concluded that continued support is justified. Support of an RPL by the COBRE mechanism beyond a total of five years is not allowed.

An RPL may be removed from the COBRE program if a review by the AC indicates a failure by the investigator to make adequate progress toward achieving the specific aims of the Research Project or meeting milestones, including the failure to submit an investigator-initiated, peer-reviewed research grant application by the end of two years of COBRE support.

Reductions in the level of effort of key personnel by 25% or more from the approved level or to a level below the required minimum stated in this FOA, require the prior approval of NIGMS. PD(s)/PI(s) should consult with NIGMS program staff in advance regarding such requests. Reductions in the level of effort of RPLs below the six-person month requirement will not be approved except in extraordinary circumstances.

When submitting a new research grant application, a RPL should include a statement acknowledging COBRE program support and a plan for relinquishing COBRE support if the proposed research is funded and overlaps with or is similar to the COBRE Project.

When an RPL obtains independent research grant funding, NIGMS must be informed no later than the start date of the new award. If the new award overlaps with the work described in the COBRE Research Project, is highly similar to the Research Project, or addresses a closely related topic, COBRE support must end when the new award begins. If the new funding is a substantial, independent NIH research award, such as an R01 or R01-equivalent award, but covers a different topic that does not overlap with or stem from the COBRE Research Project, the COBRE PD/PI may request prior approval for up to 6 months of continued COBRE RPL support with no reduction to the RPL’s level of effort on the COBRE project.

Pilot Projects

Pilot Project(s) must be reviewed by the AC. Faculty investigators of all ranks are eligible, but it is strongly encouraged that Early Stage and New Investigators be given priority for leading a Pilot Project. Individuals holding postdoctoral, trainee, or similar non-independent positions are not eligible to lead COBRE Pilot Projects.

The Center must provide assurance of full compliance with all applicable federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, select agents, and/or biohazards.

Prior approval by NIGMS is required to add a new Pilot Project. See "Prior Approval of Pilot and Replacement Research Projects" below for documents that must be submitted to NIGMS.

A PPL is required to devote at least one person-month of effort to the Pilot Project but is not named as key personnel in the COBRE award. PPL removal from the COBRE or changes to their level of effort that remain above the minimum commitment do not require prior approval but must be reported in annual Research Performance Progress Reports.

Prior Approval of Pilot and Replacement Research Projects

Prior approval from NIH is required before a Pilot Project or replacement Research Project can begin. The following documentation for each Pilot Project (PP) and replacement Research Project (RP) must be submitted to NIGMS staff for administrative review:

Using PHS398 forms and instructions, only the following sections need to be submitted:

• Face Page (PP and RP, signed by institutional signing official)
• Project Summary (PP and RP, Page 2)
• Research Strategy Section (PP and RP)
• Updated Other Support (RP only)
• Biographical Sketch (PP and RP)
• Detailed budget and budget justification (RP only)
• Checklist Format Page with F&A cost breakdown (RP only)
• Advisory Committee approval - communication from the AC Chair (at a minimum) indicating the AC concurs with supporting the project (PP and RP)
• Letter of Support from a senior institutional official demonstrating a clear commitment to support a multi-year faculty appointment for the proposed investigator (RP only)
• Resource Sharing Plan (RP only)
• Data Management and Sharing Plan (RP only, if applicable)
• Authentication of Key Biological and/or Chemical Resources (RP only)

If the proposed RP or PP involves human biospecimens or data, include:

• Current PHS Human Subjects and Clinical Trials Information Form

If the proposed RP or PP involves Human Subjects, include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Institutional Review Board (IRB) approval
• Human Subjects Education Certification (required even when research is exempt)

If the proposed project involves Clinical Trials, include:

• Current PHS Human Subjects and Clinical Trials Information Form
• Institutional Review Board (IRB) approval
• Documentation of Investigational New Drug (IND)/Investigational Device Exemption (IDE) status for studies that are subject to FDA regulation
• Human Subjects Education Certification and Good Clinical Practice (GCP) Training Certification
• For all Clinical Trials, in addition to the information requested in Section 3.3 of the PHS Human Subjects and Clinical Trials Information form, the awardee institution must provide NIGMS with a statement detailing the risks to study participants, the frequency of monitoring of clinical trial data and participant safety, and the name(s) of the responsible party/parties for regulatory and legal compliance, adverse event reporting, and clinicaltrials.gov registration and results reporting.

Note: For Human Subjects or Clinical Trials, the grantee must enter study data in the Human Subjects System (HSS) before requesting NIGMS approval.

If the proposed project involves Vertebrate Animals, include:

• IACUC approval
• Vertebrate Animal Section

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that 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 FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

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.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

In carrying out the stewardship of grant programs, NIGMS will periodically evaluate the COBRE program employing the representative measures identified below. In assessing the effectiveness of research capacity building investments, NIGMS may use information from progress reports and public databases, PDs/PIs, and from participants themselves. Where necessary, PDs/PIs and participants may be contacted after the completion of the grant period for updates on participants subsequent outcomes, as appropriate. The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

• Indicators of institutional and investigator capacity building, such as
  • Recruitment and development of faculty
  • Progression through program phases and sustainability
  • Improved access to scientific research infrastructure
  • Subsequent submission of peer-reviewed grant proposals
  • Subsequent external funding obtained by participants in the program
• Characteristics of the applicant and awardee pool for the program, such as:
  • Geographic distribution
  • Investigator demographics
  • Institution types
  • Scientific areas of focus
• Indicators of scientific productivity and impact among grantees, such as:
  • Peer-reviewed research publications and citations
  • Conference presentations

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]

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

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

Samantha Farrell, MHS
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 45 CFR Part 75 and 2 CFR Part 200.