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 VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

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 and Puerto Rico by developing faculty investigators, providing research opportunities to students, and enhancing research infrastructure.

The IDeA Networks of Biomedical Research Excellence (INBRE) program is a key IDeA component that funds one statewide network of higher education and research institutions in each IDeA-eligible state and Puerto Rico to build biomedical research capacity through supporting faculty research and research mentoring, student participation in research, and research infrastructure enhancement at network institutions. These networks aim to catalyze, develop, and strengthen research culture at network institutions, support faculty for research excellence, and provide students with research opportunities to help develop a strong biomedical research workforce.

Program Description and Requirements

Overall Plan: An INBRE Network is comprised of higher education and research institutions in an IDeA state. The lead institution of this multi-institutional network should have a broad and strong biomedical research base to lead the research and capacity building activities of the Network, as well as well-established research administration infrastructure that can effectively administer the multi-component INBRE award with sub-awards to network institutions. Primarily undergraduate institutions (PUIs), including four-year colleges, two-year colleges, and minority-serving institutions with degree programs related to biomedical research, are the intended principal participants of the Network. Sixty percent of the INBRE budget must be devoted to supporting the PUIs, their faculty and students. Institutions in the state that receive Center of Biomedical Research Excellence (COBRE) and IDeA Networks for Clinical and Translational Research (IDeA-CTR) awards must participate in the Network and make their research resources accessible to students and faculty of the INBRE Network. Other higher education and biomedical research institutions are also eligible to join the Network. INBREs are encouraged to collaborate with the NIH-supported Science Education Partnership Award (SEPA) programs in IDeA states to engage pre-college students in biomedical research. An INBRE must develop an evaluation plan to monitor and evaluate the performance and impact of the award.

The Program Director/Principal Investigator (PD/PI) of an INBRE award assumes overall scientific and administrative leadership of the Network. The PD/PI must be an established biomedical researcher holding a full-time appointment at the lead institution and with a record of successful administrative and mentoring experiences. Multi-PD/PI (MPI) applications are allowed, and a PD/PI succession plan is encouraged. A Steering Committee (SC) comprised of the PD(s)/PI(s) and one senior institutional leader (Vice President/President or equivalent) from each network institution ensures the Network’s adherence to INBRE’s mission in building research capacity statewide, and each network institution’s support of their faculty and students participation in INBRE activities. An Executive Committee (EC) comprised of the PD(s)/PI(s), one faculty lead from each network institution, and other key personnel appointed by the PDs/PIs, assists the PD(s)/PI(s) in administering the award. An External Advisory Committee (EAC) of experts provide advice on critical scientific activities and administrative decisions. (See Section IV for Composition and Responsibilities of each Committee).

Required components of the Network include an Administrative Core (AC) that also manages a Student Research Program that supports undergraduate students participation in research in addition to other administrative responsibilities for the Network, a Developmental Research Project Program (DRPP), and a Data Science Core (DSC). Optional components include Research Cores and Alteration and Renovation Projects. All proposed components must be integral to attaining the goals of the Network and are expected to interact with each other and with relevant existing programs in the state to foster a collaborative research environment.

Administrative Core (required): The Administrative Core (AC) administers the INBRE award. It is led by the PD(s)/PI(s) and may include a Program Coordinator (PC) as well as staff essential for administering the award. Responsibilities of the AC include:

• Preparing accurate and timely program and financial reports;
• Ensuring all network activities are in compliance with federal regulations and requirements;
• Managing the Network's budget;
• Coordinating activities of all components and committees of the Network; and
• Conducting evaluation of the INBRE award.

The AC manages a Student Research Program (SRP) that supports undergraduate student participation in mentored research during the summer break and/or academic semesters. Students in all fields of study enrolled in network institutions may apply for SRP support. INBREs of states with fewer than four accredited higher education institutions that award degrees in biomedical sciences may expand the SRP eligibility to high school students. Faculty investigators conducting research in all biomedical fields in network institutions of the INBRE, including PDs/PIs of IDeA awards, may serve as preceptors for SRP-supported students. Information about the SRP, including eligibility criteria for student participants and faculty preceptors, levels of support to be provided, the application and selection process, methods for matching students with preceptors, expectations for the students and matrix for evaluating their research experience, expectations for the preceptors and matrix for evaluating their research experience, and roles and contact information of individuals managing SRP at the AC and each network institution, must be disseminated to students and faculty of network institutions.

The AC should organize a network-wide annual research conference. SRP-supported students should be given opportunities to present their research outcomes and share their experience at the conference.

The AC may sponsor research, career enhancement and mentoring activities for faculty and students, such as lecture and seminar series, grantsmanship and scientific presentation workshops, career counseling, and graduate school application workshops. The AC may also support faculty efforts to incorporate research into the science curricula at PUIs and provide financial support to help PUIs to recruit faculty in biomedical sciences.

Developmental Research Project Program (required): An INBRE Network must support a Developmental Research Project Program (DRPP) led by an established scientist with experience in mentoring and applying for external research funding. If the DRPP funds projects involving human subjects including clinical trials, the lead of the DRPP assumes the oversight responsibilities of these studies. The DRPP administers grants to faculty investigators at network institutions supporting Research Projects (RPs) and/or Pilot Projects (PPs). A RP may be funded for up to two years with direct costs up to $125,000 per year. Six person months effort is required of a RP leader. A PP may be funded for one year with direct costs up to $50,000. Three person months effort is required of a PP leader. These awards are renewable. Student participation is strongly encouraged for all DRPP-funded research. Information about the DRPP including applicant eligibility criteria, the application, review, and selection process, expectations for RP and PP leaders and matrix for evaluation, and roles and contact information of individuals managing SRP must be disseminated through the network.

Data Science Core (required): Each INBRE must support a Data Science Core (DSC) to provide faculty and students access to data science resources, services and training needed for biomedical research. The DSC is expected to develop data science expertise including scientific programing, data analysis, data management, data security, and access to big data and cloud computing for biomedical research to meet the needs of faculty and students throughout the Network. The DSC should encourage and facilitate utilization of biomedical data repositories and knowledge bases in INBRE-supported research. The DSC is expected to provide training and/or introduce training opportunities to faculty and students in emerging data science disciplines such as machine learning, deep learning, and artificial intelligence. Collaborations across other INBRE Data Science Cores for sharing training and research resources are strongly encouraged.

Research Core(s) (optional): An INBRE may support Research Cores if a broad user base for such cores among faculty and students in the Network is anticipated. A Research Core should be accessible to all faculty and students in the Network and should not duplicate services available through facilities that already exist within the Network, or that are supported by other IDeA programs, e.g., IDeA-CTR and COBRE(s) in the state.

Alteration and Renovation Projects (optional): Alteration and Renovation (A&R) projects at PUIs to improve existing research laboratories or animal facilities that will be used broadly by students and faculty in the Network are allowed. More than one A&R project may be proposed as long as the costs do not exceed the allowed budget cap.

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 among network institutions in all biomedical research areas, including fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
• Engagement from different types of institutions and organizations in the state (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.

This FOA requires a PEDP as part of the application (see Section IV.2 SF424(R&R) Other Project Information. Other Attachments). Accordingly, the examples listed above may be included, if they are appropriate for the goals and requirements of the INBRE program. For further information on the PEDP, please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Only institutions located in the following states/commonwealth are eligible to apply for the INBRE: Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, and Wyoming.

Eligible network partner institutions may be primarily undergraduate institutions (PUIs), defined as four-year colleges, two-year colleges, and minority-serving institutions that award associate degrees, bachelor’s degrees, and/or Master’s degrees in biomedical sciences, but have awarded 20 or fewer Ph.D./D.Sc. degrees in biomedical sciences in the previous two academic years; and other higher education and biomedical research institutions.

The application must be submitted by the eligible organization with a unique entity identifier (UEI) and a unique NIH eRA Institutional Profile File (IPF) number. For institutions with multiple campuses, eligibility can be considered for an individual campus (e.g., main, satellite, etc.) only if a UEI and a unique NIH eRA IPF number are established for the individual campus. For institutions that use one UEI or NIH IPF number for multiple campuses, eligibility is determined for the campuses together.

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/PI or the contact PD/PI of a Multiple PD/PI (MPI) application must be a full-time employee of the lead institution and an established biomedical researcher with mentoring and administrative experiences necessary to lead the multi-component INBRE program.

MPIs from different Network institutions are encouraged, particularly when they bring diverse and complementary expertise. For MPI applications, each PD/PI must commit at least two person months effort to the INBRE.

An INBRE PD/PI may not simultaneously serve as a COBRE or IDeA-CTR PD/PI, nor can a COBRE or IDeA-CTR PI simultaneously serve as a PD/PI of an INBRE.

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

An eligible institution in a state may submit one application for the state-wide INBRE award.

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.

Facilities and Other Resources: Resources including equipment and instrumentation at the applicant institution to support INBRE research activities should be described.

Other Attachments: The application must include the following attachments:

1. Memorandum of Understanding (MOU): An MOU between each of the network institutions and the INBRE must be included. The MOUs must clearly describe the institutions commitment to provide release time for DRPP-supported investigators to meet the required level of effort, which is 6 person months for RP leaders, and 3 person months for PP leaders. This attachment should be titled Memorandum of Understanding.
2. 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 Network 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, applicants 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 Network 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 (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the Network 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 questions.
• 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 underrepresented backgrounds.

For further information on the PEDP, please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples.

This attachment should be titled Plan for Enhancing Diverse Perspectives.

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.

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 overall Network.

Research Strategy:

A. Progress and Accomplishments (if applicable): Renewal applications must provide a description of progress and accomplishments made during the current 5-year INBRE funding period in the following areas (use tables where appropriate):

• Number of faculty leading research projects funded by the INBRE.
• Number of faculty leading pilot projects funded by the INBRE.
• Number of students supported by the INBRE including the SRP and DRPP.
• Number of undergraduate and high school students, when applicable, supported by the INBRE SRP.
• Scientific publications in peer-reviewed journals resulting from INBRE support.
• Presentations at scientific meetings or to the general public by investigators and students funded through INBRE.
• Grant applications submitted by and awarded to INBRE-supported investigators.
• Infrastructure enhancement as measured by new and/or improved facilities at network institutions supported by the INBRE.
• The usage of INBRE Data Science Core and Research Cores, if applicable, by INBRE and non-INBRE investigators.
• Research collaborations among Network researchers, institutions, and IDeA programs.
• Other accomplishments and/or progress.

B. Organization: The application must provide descriptions of network institutions, components, committees, and the organizational relationship among them, including the following elements:

• A description of the lead institution’s biomedical research departments/programs, including NIH research funding they receive and the number of students enrolled in these departments/programs currently.
• A description of the lead institution's research administration infrastructure that will administer the INBRE award and subawards.
• A list of other network institutions and a brief description of their respective departments/programs that will participate in the INBRE, including the number of students enrolled in these departments/programs.
• A description of components proposed. Provide justifications if any optional components are proposed.
• A description of the three required INBRE committees that will assist the PD(s)/PI(s) in administering the award:
  • Steering Committee: The Steering Committee (SC) is comprised of the PD(s)/PI(s) and one senior institutional leader (Vice President/President or equivalent) from each network institution. The PD/PI (or the contact PD/PI) of the INBRE award serves as the Chair. The SC is responsible for ensuring the INBRE’s adherence to its mission in building research capacity in network institutions state-wide, and for network institutions commitment and support for their faculty and students' participation in INBRE activities. The SC should be consulted for decisions with network-wide impact, such as a change in network membership, appointment of the EAC Chair, alterations to program priorities and key policies, and initiation/termination of significant initiatives. An operating plan for the SC, including the names and positions of its members, should be provided.
  • Executive Committee: The Executive Committee (EC) assists the PD(s)/PI(s) in establishing policies, developing initiatives, overseeing components of the INBRE, making funding recommendations, and coordinating network-wide activities. The PD/PI (the contact PD/PI in case of MPIs) serves as Chair of the EC. Members of the EC include one faculty lead from each network institution, and others with critical roles in administering the award appointed by the PDs/PIs. The EC must submit semi-annual progress reports to the EAC. An operating plan for the EC, including the names and positions of its members, should be provided.
  • External Advisory Committee: An INBRE program must establish an External Advisory Committee (EAC) to provide advice to the PD(s)/PI(s). The EAC is comprised of three to five members with appropriate expertise in research, mentoring, and administration. Members of the EAC are appointed by the PD(s)/PI(s). The Chair of the EAC is appointed by the PD(s)/PI(s) in consultation with the SC. The EAC reviews the performance of each component of the INBRE on a semi-annual basis and provides advice to the PD(s)/PI(s). The EAC is expected to provide advice to the PD(s)/PI(s) on a regular basis and must submit annual reports to the SC evaluating the performance of the INBRE as well as its components and making formal recommendations. An operating plan for the EAC should be provided that includes a description of the process for filling EAC vacancies and the name, position, and scientific expertise of each continuing EAC member. For new members, provide a description of the expertise desired without naming the individuals or contacting them prior to receiving a Notice of Award for the application.
• A description and/or an illustration of the organizational relationship among the components and committees proposed.

C. Overall goals and general strategies

• The overall goals of the INBRE must be clearly articulated. Important milestones and benchmarks should be provided.
• Describe the general strategies to achieve the goals. These include but are not limited to:
  • Leadership and governance plans.
  • Plans to amplify the success and address shortcomings of the current funding period for Renewals.
  • Plans to improve/strengthen the INBRE through new ideas or initiatives.
  • Innovative approaches.
  • Plans for partnerships, collaborations, and resource-sharing.

Letters of Support: A letter of support from a senior official of each of the network institutions is expected to demonstrate institutional commitment for supporting its faculty and students to participate in INBRE activities. Additional institutional commitment in the form of financial support, space, equipment, etc., may be included in the letter.

As appropriate, letters from the PD(s)/PI(s) of other awarded programs, including NIH and other federal and non-federal entities (e.g., INBREs, COBREs, IDeA-CTRs), may be included to indicate their role in supporting the INBRE's goals and objectives.

Additional letters addressing substantive and specific needs may be included.

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 Lead 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 should be included in the application package.

Of the $2.75 million direct costs per year, $1.65 million (60% of the requested budget) is for the PUIs as consortium arrangements and/or subcontracts to build infrastructure and research capacity for biomedical research. Funds allocated to PUIs are to cover expenses supporting undergraduate students through the SRP, DRPP grants, and other research and equipment costs. Costs for supporting high school students are allowable if they are accepted in the Student Research Program. A maximum of 15% of the total direct cost requested at each PUI may be used for administrative costs, including support to develop and/or strengthen Offices of Sponsored Programs. The remaining $1.1 million (40% of the requested budget) may be used to support the Administrative Core (AC) including the SRP funds used to support students of non-PUI institutions, Data Science Core, and Research Cores if applicable. DRPP grant funds awarded to non-PUI institutions in the Network also included in this $1.1 million.

INBREs in states that have fewer than four accredited high education institutions that award degrees in biomedical sciences may consider the budgetary allocation guideline of $1.65 million direct costs to PUIs optional. States that qualify for this flexibility, should identify this in the application, and also include a detailed plan on how they propose to use the funds. These INBREs are encouraged to support high school students through their Student Research Program. They may also use INBRE funds to assist PUIs efforts to recruit faculty in biomedical sciences.

The PD/PI who also serves as the Administrative Core Lead, must devote a minimum of 3.6 person months per year to lead the Network although up to 6.0 person months can be requested with justifications. For MPI applications, while the combined level of effort for the PDs/PIs cannot exceed 7.2 person months, all PD/PIs must meet the same eligibility requirements as described, and each must commit at least 2.0 person months effort to the INBRE. A PD/PI may not use INBRE funds to support research or the research team in their own laboratory and is not eligible to serve as a project lead on any IDeA (e.g., INBRE, COBRE, or IDeA-CTR) award. An IDeA awarded PD/PI may serve as a preceptor for the SRP students.

A Program Coordinator (PC) may be appointed by the PD(s)/PI(s) to coordinate activities of the Administrative Core and the Network including the SRP. Funds may be requested to support the PC and other staff who lead critical functions of the INBRE such as managing the budget and conducting INBRE evaluation.

Funds to support the SRP including compensation for student participation, supplies, and assistance for travel should be requested.

Funds to support other activities for research, career development, outreach, curriculum enhancement at PUIs, or faculty recruitment at PUIs the AC intends to support, may be requested.

Funds to compensate EAC members as consultants via a fee-for-service arrangement may be requested in the Administrative Core budget. The EC members from the network institutions may receive compensation from the INBRE.

Costs for research collaborations with U.S. and/or foreign institutions are allowable. While INBRE funds may not be transferred via subcontract to an institution in a non-IDeA state or foreign country, the funds may be used for fee-for-services such as technical training, sample collection, and data analysis. Funds may also be used for attending scientific conferences in domestic as well as foreign sites.

Funds should be requested for the PD(s)/PI(s) and other key personnel funded through this FOA to attend the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meetings.

Students participating in the INBRE network are compensated as Student Researchers based on the time devoted to their participation in the grant activity. Tuition remission is allowable as long as it meets the guidelines set forth by the NIH Grants Policy Statement and the award recipient’s institutional policies.

Stipends" as defined by the NIH are a cost of living allowance for trainees under the Kirschstein-NRSA fellowships and institutional research training grants and are not allowable for INBRE.

An honorarium is not an allowable expense. However, a payment for services rendered, such as a speaker's fee under a conference grant, is allowable.

If requesting items that are normally treated as F&A costs (for example, general office supplies) as direct costs, the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that a particular item will have on the associated component. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

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

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 the Administrative Core component.

Specific Aims: The instructions in the SF424 (R&R) Application Guide must be followed.

Research Strategy: This section should describe:

• The role and responsibilities of the PC, if applicable.
• The plan for the Student Research Program, including:
  • the eligibility of applicants, number of students to be selected and supported, and duration of the support.
  • the application and selection processes.
  • how students will be matched with preceptors.
  • expectations for students and preceptors.
  • plans to track outcomes and evaluation matrix.
  • how information about the SRP will be disseminated.
• Plans for other activities for research, career development, outreach, curriculum enhancement at PUIs, or faculty recruitment at PUIs the AC intends to support, and how each of these activities will contribute to the INBRE goals.
• The plan for coordinating and supporting the activities of the three governance committees - SC, EC, and EAC.
• The plan for coordinating activities supported by the AC and other components of the Network.
• The financial management plan, including details to ensure PUIs of the Network receive 60% of the funds and to provide accurate and timely financial reports.
• The plan to provide accurate and timely progress reports.
• The overall Evaluation Plan including metrics, benchmarks, and timelines that are appropriate for students, investigators, and programs supported by the INBRE to monitor and evaluate the performance and impact of the award.
• A succession plan for the PD/PI, or the contact PD/PI for MPI applications, if applicable.

Letters of Support: As letter(s) from network institutions demonstrating support for the INBRE and its components will be included under the Overall section, no letters should be included here.

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 (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

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.

Developmental Research Project Program

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 (Developmental Research Project Program)

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 (Developmental Research Project Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Developmental Research Project Program)

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) (Developmental Research Project Program)

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 (Developmental Research Project Program)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Program Lead 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 (Developmental Research Project Program)

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

The RP leaders (RPLs), preferably early-stage investigators (ESIs), will devote at least six person months, for up to two years with a budget not to exceed $125,000 per year in direct costs. The effort can be distributed over the year to achieve a total of six person months (for example, three person months during the academic year and three person months in the Summer to account for a yearly six person months effort). The PP leaders (PPLs) will devote at least three person months for one year with their individual award budgets not to exceed $50,000 per year in direct costs. Institutions must provide adequate release time for RPLs and PPLs for commitment to their research projects. Grant funds may not be used to pay the salary of another individual for course release time.

An RPL who receives a DRPP award that requires six person months effort must be assigned a mentor, who has experience in research and has obtained external research funding. Investigators who receive DRPP awards that require less than six person months effort should also be assigned a mentor, unless the awardees are already senior faculty experienced in leading research projects. A mentor may be supported for up to 1.0 person month. In instances where a suitable mentor is not available within the Network, it is acceptable to have an appropriate mentor from outside the network.

COBRE, INBRE and IDeA-CTR Research and Pilot Project leaders are not eligible for simultaneous research funding from two IDeA programs. COBRE and IDeA-CTR supported investigators may serve as mentors of INBRE RPLs and PPLs as appropriate.

DRPP funds may be used for salary for the DRPP investigators, postdoctoral fellows, students (including graduate, undergraduate and high school students), and research assistants/technicians, as well as to pay for supplies and/or equipment costs.

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 (Developmental Research Project Program)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Developmental Research Project Program component.

Specific Aims: The instructions in the SF424 (R&R) Application Guide must be followed.

Research Strategy: INBRE applications should not include proposals for individual RPs or PPs in the application. Selected RPs and PPs will require prior approval from the NIGMS (see Section VI) post award. The plan for the DRPP should include:

• Goals and expectations for RPs and PPs if applicable.
• Budget, duration, and estimated number of awards to be issued in each project category.
• Eligibilities and pool of applicants for each project category.
• Plans to develop, issue, and disseminate funding opportunity announcements.
• Application and selection process.
• Plans for recruiting mentors for DRPP investigators and matching them with DRPP investigators.
• Expectations for mentors, and plans to train mentors, and track and evaluate mentoring performance.
• Plans to track and evaluate the performance of the DRPP.
• Plans to assure compliance with applicable federal policies and guidelines for research and research protections.
• If the DRPP intends to support projects involving short-term (1-2 years) clinical trials, plans for the lead of the DRPP to provide oversight that ensures:
  • clinical trials have a strong scientific rationale and are ethical, safe, inclusive and effective;
  • preliminary data and/or literature support for the clinical trial;
  • the project leaders and key personnel will have the expertise, experience, and ability to design, organize, and implement the proposed clinical trial, as well as to manage data and statistics safely;
  • the appropriate mentoring and oversight will be in place to assure safety of the clinical trial;
  • potential ethical issues will be adequately addressed; and
  • proposed trial sites will have appropriate research capacity to support the trials.

Letters of Support: As letter(s) from network institutions demonstrating support for the INBRE and its components will be included under the Overall section, no letters should be included here.

MOU between each of the network institutions and the INBRE must be included. The MOUs must clearly describe the institutions commitment to provide release time for DRPP-supported investigators to meet the required level of effort, which is 6.0 person months for RP leaders, and 3.0 person months for PP leaders.

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 (Developmental Research Project Program)

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

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

Delayed Onset Study

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

Data Science 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 (Data Science 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 (Data Science Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Science 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) (Data Science 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 (Data Science 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 (Data Science Core)

• Budget forms appropriate for the specific component should be included in the application package.
• DSC should have a detailed budget for the entire proposed project period (five years).
• Funds may be requested to cover the salary of the DSC Director and staff, including recruitment of new staff to develop appropriate expertise.
• Funds may be requested to procure appropriate equipment, software, service, and access to data, data management, and cloud computing time.
• Funds may be requested for data science educational activities.

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 (Data Science Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Data Science Core component.

Specific Aims: The instructions in the SF424 (R&R) Application Guide must be followed.

Research Strategy: This section should describe:

• Existing infrastructure, services, and other related resources for investigators and students.
• Plans to develop data science expertise including scientific programming, data analysis, data management, data security, using big data and cloud computing for biomedical research.
• Plans for data science educational activities including topics, sources of content, intended participants, and providers of the educational activities.
• How the DSC will meet the research needs of INBRE-supported investigators and network partners for data science services.
• The qualifications and role of the DSC Director and other key personnel, without duplicating information already provided in the Biosketch.

If an individual is serving in an advisory role or their inclusion is integral to the Core, they should be listed as a key person in the application.

Letters of Support: As letter(s) from network institutions demonstrating support for the INBRE and its components will be included under the Overall section, no letters should be included here.

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 (Data Science 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

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

Delayed Onset Study

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

Research Core(s)

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.

Facilities and Other Resources: The applicants should describe the scientific environment including physical resources in which the research will be done. A description of the major existing equipment and instrumentation for conducting research should be provided.

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 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 (Research Core)

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

Funds may be requested to establish, maintain, and/or improve Research Core facilities that are essential to support the research of the Network. In addition to costs for acquisition or modernization of instrumentation and supplies, personnel costs may be requested. The level of personnel support requested must be justified by the projected use by researchers from the network institutions.

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 for the Research Core component.

Specific Aims: The instructions in the SF424 (R&R) Application Guide must be followed.

Research Strategy: If a Research Core is requested, it must provide service to a significant number of investigators supported by the INBRE and as possible, the broader research community in the network institutions. The resource cannot be duplicative of those currently supported by the IDeA program in the state or by network institutions. The important elements to include in this section are:

• A description of the anticipated research needs of the DRPP and existing resources currently supported by the IDeA programs in the state. Provide justification for supporting the Research Core.
• For continuation of an existing Core in a Renewal application, provide a summary of services it offered in the current funding cycle and the outcomes, and a justification for continued support.
• An operating plan covering personnel, additional equipment, maintenance, as well as service and user training to be provided.
• A description of the Core’s user base, including INBRE users who get services at no cost and non-INBRE users. Provide a business plan that includes marketing and a user fee structure for non-INBRE users.
• A description of the qualifications and role of the key personnel and the Research Core Director, without duplicating information already provided in the Biosketch.

If an individual is serving in an advisory role or their inclusion is integral to the Core, they should be listed as a key person in the application.

Letters of Support: As letter(s) from network institutions demonstrating support for the INBRE and its components will be included under the Overall section, no letters should be included here.

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 (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.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

Alteration and Renovation

When preparing your application, use Component Type Alt and Renov.

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

SF424 (R&R) Cover (Alteration and Renovation)

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 (Alteration and Renovation)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Alteration and Renovation)

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.

Other Attachments: Line drawings for each A&R project should be submitted as described below:

• Submit line drawings but do not submit blueprints. All floor plans must be legible, with the scale clearly indicated.
• The line drawings of the proposed renovation(s) must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given.
• The floor plan should indicate the location of the proposed renovation area(s) in the building(s).
• Include the as-built drawings of the proposed renovation area(s) and indicate any areas that will be demolished.
• Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan.

This attachment should be titled Line Drawing.

Project /Performance Site Location(s) (Alteration and Renovation)

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 (Alteration and Renovation)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead 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 (Alteration and Renovation)

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

Alteration and Renovation (A&R) to improve existing Core laboratories and/or research laboratories at PUIs of the Network is allowed up to $250,000 in direct costs only in year one of the award as a one-time cost expenditure. These funds may be used to support more than one project. Direct costs requested for A&R are not subject to facilities and administrative costs (F&A). If not expended in year one, prior approval for carry-over will be required. It is expected that the funds be expended within three years of the award.

Sufficient details must be provided to estimate the cost and suitability of the project. Failure to adequately justify A&R requests will likely result in their removal from the requested budget. A&R funds provided under this FOA cannot support new construction, including completion of shell space, or the purchase of movable research equipment or instrumentation, or equipment intended for teaching or other non-research related purposes. Proposed improvements are only allowed at the PUIs of the Network.

Provide an itemized budget and justification of the impact that A&R will have on the INBRE faculty and students. Provide justification of all fixed equipment items requested for the renovated area. Provide vendor quotes when available.

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 (Alteration and Renovation)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Alteration and Renovation component.

Specific Aims: The instructions in the SF424 (R&R) Application Guide must be followed.

Research Strategy: A narrative summary as outlined below must be provided for each proposed A&R project:

• A description of how proposed renovations will serve the anticipated research supported by the DRPP.
• If renovations to animal facilities are proposed, applicants must include how compliance with relevant laws, policies, and guidelines is achieved, in addition to the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) should also be included.
• List the functional components, including the size (dimensions) and square footage of each module (room, alcove, or cubicle), that will be directly affected by the renovation project.
• List engineering criteria applicable to each module (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam.
• List appropriate architectural criteria (such as width of corridors and doors, surface finishes).
• List and justify all fixed equipment items requested for the renovated area. A list of allowable fixed equipment can be found at https://www.nigms.nih.gov/Research/DRCB/IDeA/Documents/List_of_AME.pdf.
• Indicate the type(s) of new finishes to be applied to room surfaces.

Letters of Support: As letter(s) from network institutions demonstrating support for the INBRE and its components will be included under the Overall section, no letters should be included here.

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 (Alteration and Renovation)

Not Applicable

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applications must include a PEDP submitted as an Other Attachment on the SF424(R&R) Other Project Information form. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn without review.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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 provide an overall impact score to reflect their assessment of the likelihood for the network 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 network 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 network that by its nature is not innovative may be essential to advance a field.

Significance

• Does the Network address an important problem or a critical barrier to progress in building research capacity?
• If the aims of the Network are achieved, how will research infrastructure and the biomedical workforce pipeline be improved?
• Is there strong evidence that the Network will significantly strengthen biomedical research capacity at the network institutions?
• Is there strong evidence for active participation of all network institutions?
• To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further enhance the significance of the Network?

Investigator(s)

• Are the PD(s)/PI(s) well suited to lead the Network? Do they have the appropriate qualifications and skills to provide scientific and administrative leadership in directing all the components of the INBRE, and to continue building and strengthening the research network?
• For MPI applications, do the PDs/PIs bring complementary expertise; are their leadership approach and responsibility sharing arrangements appropriate for the Network?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the Network?

Innovation

• Are novel approaches proposed to increase the research opportunities for faculty and students at the network institutions, and build a diverse biomedical research workforce?
• Are novel approaches proposed to increase the participation of undergraduate students in research?
• Are needs of the network institutions and investigators addressed in appropriately creative ways?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives contribute to innovation?

Approach

• Are the proposed activities appropriate to accomplish the goals of the INBRE?
• Are the components of the Network structured as required and able to support the proposed activities effectively?
• Is the Network appropriately organized to enable synergistic collaboration and coordination of its components?
• Does the overall plan provide confidence that the Network will address those needs?
• Does the application include sound plans to improve the current Network? Are reasonable benchmarks for success presented?
• Are the roles of the SC, EC and EAC clearly described and appropriate? Do the members of the SC, EC and EAC possess appropriate expertise for their respective functions?
• Is there a sound plan to coordinate the activities of the network institutions, components, and committees to maximize the Network’s success?
• Does the applicant describe an effective plan to reach institutions statewide?
• Are plans for networking, sharing of resources, and cross-collaborations with other NIH-supported programs such as COBREs and IDeA-CTRs appropriate?
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

• Does the lead institution demonstrate the institutional commitment to support the goal of strengthening the biomedical research capacity in the statewide Network?
• Does the lead institution have a strong and broad research base and well-developed research administration infrastructure to lead the Network?
• Do the network institutions demonstrate institutional commitments to support the goal of the Network?
• Do the network institutions have appropriate faculty investigators and student body to benefit from the Network?
• For renewals, has the prior INBRE support improved facilities or made available new and collaborative resources (e.g., laboratory facilities, laboratory space, and personnel)?
• Are the institutional support, equipment and other physical resources being made available to INBRE investigators adequate for the anticipated research activities?
• Do the environment and resources available at the network institutions meet the needs of investigators and students? Will the INBRE enhance, complement, and extend the state's current resources for biomedical research?
• To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the Network?

Review Criteria for Components

Each of the following components of the application will be assessed and given a score; the component scores will also be considered in assigning an Overall Impact score to the overall application.

Administrative Core

• Does the Organizational Plan for the Administrative Core provide confidence that the goals of the Network will be fully implemented?
• Does the PC have the qualifications, experience, and committed time to assist the PD/PI in administering the components and activities of the Network? Are the roles and responsibilities of the PC clearly described?
• Does the Student Research Program Lead, if an individual different from the PC, have the qualifications, experience, and committed time to direct the program?
• Are plans to manage the research mentoring and career development of investigators and students well-defined and appropriate? Will these plans be effective in meeting the Network's goals?
• Is the plan to manage and coordinate the activities of components and committees well-integrated?
• Are there well-developed plans for selection and tracking of students for the Student Research Program? Do the plans specify activities to be conducted; and are these plans appropriate for students?
• Are the plans for mentor training to prepare mentors adequate, and to evaluate their mentoring activities appropriate?
• Is there a clear plan to manage the Network's budget, prepare, and submit accurate and timely financial reports?
• Are there clear plans to ensure all network activities will be in compliance with Federal regulations and NIH policies?
• Are there appropriate plans to organize Network-wide research and career development activities?
• Do the MOUs between the INBRE and network institutions describe adequate release time to DRPP investigators?
• Are there appropriate and suitable evaluation strategies and useful milestones to measure progress, not only of the investigators, but of the Network toward attaining its long-range goals?

Developmental Research Project Program

• Does the DRPP Lead have the qualifications and experience to lead the DRPP?
• Is the DRPP well integrated into the overall INBRE goals? Is the program designed to serve the needs of network investigators in biomedical research?
• Are the tracking and evaluation methods proposed adequate to assess the impact of the DRPP on the research capacities of the network institutions?
• Are there well-developed plans for proposal solicitation, review, award selection, and performance evaluation?
• Is there a pool of qualified investigators from network institutions to solicit applications?
• Are the plans for reviewing applications and selecting award recipients transparent and fair?
• Are plans adequate to assure compliance with applicable federal policies and guidelines for research and research protections?
• If the DRPP intends to support projects involving clinical trials, are plans to ensure ethical, safe, inclusive, and effective clinical trials included?

Data Science Core

• Does the DSC Director have the qualifications and expertise to lead the DSC in enhancing research and providing educational activities for the Core?
• Are plans to develop data science expertise in the DSC adequate?
• Are plans for educating investigators and students about effective use of data science tools and resources, including cloud computing, appropriate? Do these plans include education in quantitative and computational research skills?
• Are plans to facilitate INBRE-supported research projects that will use data science approaches adequate?
• Are plans to provide data science resources to the network adequate and feasible?
• Is there adequate institutional commitment to support and maintain the ongoing and proposed Core activities?
• Are the operating procedures of the Core appropriate and reasonable?

Research Cores (if included)

• Does the Core Director have the qualifications and expertise to provide the necessary oversight to administer the maintenance and growth of existing Core resources/services to support the scientific needs of investigators and students?
• Is the proposed Research Core appropriate and justified for the needs of the overall INBRE program?
• Are the proposed services and operation plans appropriate to accomplish the aims of the Core?
• Is there evidence of sufficient institutional support to maintain the ongoing and proposed Core/services?
• If support for instrumentation to augment existing or new Core facilities is requested, are the needs appropriately justified by the ongoing or proposed research and/or training needs of the Network?
• Are the Core’s userbase and business plan, including marketing, reasonable? Does the plan provide confidence that new users will be developed?
• Are the criteria for prioritization and usage of the Core resources and services appropriate to meet the needs of network investigators and students?

Alteration and Renovation (if included)

Scientific Needs:

• Is the requested alteration and renovation project(s) needed to support the goals of the Network?
• Are the costs of the project(s) appropriate?
• Are the lines of authority and responsibility for administering the institution's animal care and use program described?

Architectural Plans:

• Do the descriptions of the alterations and renovations, including equipment requests, adequately describe what will be done and strongly justify the request? Do the line drawings provide sufficient detail to describe the project? Do they indicate that the proposed alteration and renovation is feasible and that it will serve its intended purpose?
• Are the functional components, including the size (dimensions) and square footage of each component (room, alcove or cubicle) that will be directly affected by the renovation project appropriate for the intended use of the space? Are appropriate descriptions of the engineering criteria (mechanical, electrical, and utilities) provided, including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes)? Is the need for all fixed equipment requested for the renovated area well justified?

As applicable for the application 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.

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 Animals 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 review committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress and program accomplishments made in the current funding period as follows:

• Has the INBRE brought together sufficient institutions in the state to create an effective statewide Network to develop and enhance research capacity?
• Has the INBRE made progress in specific areas, such as:
• engaging students and faculty participation in biomedical research;
• enhancing faculty development;
• providing investigators with access to needed research resources;
• publishing research findings in peer-reviewed journals;
• obtaining extramural research funding;
• and enhancing science curricula at the PUIs.
• Is there evidence that students INBRE experiences have had a positive effect on their pursuit of biomedical-related careers?

Revisions

Not Applicable

As applicable for the application 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 National Institute of General Medical Sciences, 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 will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. Only one award will be made per IDeA-eligible state. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

Program Coordinator and Data Science Core Director are key personnel on the Notice of Award.

PD(s)/PI(s), Program Coordinator and Data Science Core Director of INBRE are expected to attend the National IDeA Symposium of Biomedical Research Excellence (NISBRE) biennial meeting.

Research/Pilot Project Leaders

INBRE support cannot be provided in instances where research/pilot project leaders' have an award from any other source that overlaps or is significantly similar to that described in the INBRE program application. When submitting a new research grant application, the INBRE funded investigators should include a statement acknowledging INBRE program support and a plan for relinquishing that support if the proposed research overlaps or is similar to the INBRE project.

If the specific aims of the newly funded project are significantly different from the project described in the INBRE, then that project leader has an obligation to remain in the program to complete his/her INBRE project. In the latter case, continued support for personnel associated with the INBRE project and who are also listed on the new award, can be provided. However, the percent efforts of these individuals must be appropriately adjusted.

Investigators who have completed an INBRE-supported research/pilot project should not be excluded from the Network activities. These investigators should be allowed access to Core facilities and should be encouraged to participate in collaborative research efforts. If appropriate, an investigator who has completed an INBRE-supported research/pilot project may direct an INBRE Core facility or serve as an advisor/collaborator.

INBRE funding to an investigator may be terminated if a review by the EAC indicates a failure by the investigator to make significant progress toward achieving the specific aims of his/her project. Prior approval by the NIGMS is required for adding or removing investigators. The PD(s)/PI(s) must communicate the EAC's recommendation to the NIGMS for programmatic and administrative review.

Prior Approval of Research and Pilot Projects

New INBRE RPs and PPs that do not include human subjects or vertebrate animals research will only require official notification to NIGMS with appropriate documentation, including the EAC approval, at least 14 days before the projects begin. Prior approval by NIGMS is no longer required to initiate these projects.

New INBRE RPs and PPs that include human subjects or vertebrate animals research will continue to require NIGMS prior approval before the projects can begin. The following documentation for each project must be submitted to NIGMS Program Official and Grants Management Specialist listed on the Notice of Award for administrative review at least 30 days before the projects begin (see Notice NOT-GM-14-111 for details):

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

• Face page (signed by an institutional signing official)
• Project Summary (page 2)
• Research Strategy
• EAC approval communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the research/pilot project
• If the proposed project involves human biospecimens or data, include:
  • Current PHS Human Subjects and Clinical Trials Information Form
• If the proposed project 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 short-term (1-2 years) 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 will 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 Animals 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.

In the RPPR, include progress towards the program accomplishments listed in the description of the overall research program) to assist in evaluating the program. Progress reports should briefly describe status of DRPP Projects, including data and safety monitoring, and should notify NIH of serious adverse events, and unanticipated problems for human subjects and clinical trials projects. Criteria for evaluating the progress of DRPP investigators may include evidence of scholarly activities including publications, offering of new courses and programs, providing research experiences to students, attending and presenting research findings at scientific meetings and conferences, submission of external grant applications to NIH and other federal and non-federal agencies, and acquisition of awards such as Academic Research Enhancement Award (AREA, R15), Support for Research Excellence (SuRE, R16), and exploratory/pilot project grants (R03 and R21) that are appropriate to the mission of their institutions. Outcomes of students who participate in INBRE research and/or career enhancement activities should be tracked and reported in the RPPR (for example, the total number of students who had research experiences, have gone to graduate and professional schools, or have entered the biomedical workforce). In addition to submitting annual progress reports, INBRE awardees are also required to provide Supplemental Programmatic Data in the NIGMS Scientific Information Reporting System (SIRS). The SIRS system can be accessed at: https://sirs.nigms.nih.gov. Like the RPPR submission, SIRS submissions are due 60 days before the end of the active budget period. Approved DRPP Projects should be reported as separate components in the RPPR.

A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.

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.

Evaluation

In carrying out the stewardship of grant programs, NIGMS will periodically evaluate the INBRE 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 Network, institutional and investigator capacity building, such as
  • Development, including recruitment, of faculty
  • Improved access to scientific research infrastructure
  • Subsequent submission of peer-reviewed grant proposals
  • Subsequent external independent funding obtained by DRPP participants in the program
• Characteristics of the applicant and awardee pool for the program, such as:
  • Geographic distribution
  • Investigator demographics
  • Institution types
• Indicators of scientific productivity and impact among Network institutions, such as:
  • Peer-reviewed research publications and citations
  • Conference presentations
• Indicators of research Network development and collaboration, such as:
  • Number and characteristics of partner organizations
  • Resources shared among partner organizations
  • Research collaborations established across network institutions
• Outcome measures for educational/student activities, such as:
  • Curriculum development and enhancement; courses and workshops offered for enhanced scientific and career skills development
  • Research experiences obtained by students
  • Mentoring activities conducted with students
  • Student authorship in scientific research publications
  • Subsequent participation of students in the biomedical research workforce

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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Krishan K. Arora, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: arorak@nigms.nih.gov

National Institute of General Medical Sciences (NIGMS)
Email: NIGMSReview@mail.nih.gov

Lisa Hildred
National Institute of General Medical Sciences (NIGMS)
Email: HildredL@nigms.nih.gov

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.