National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
P20 Exploratory Grants
December 21, 2023 - TClarification of Data Management and Sharing Plan Instructions in PAR-23-100. See Notice NOT-GM-24-022
June 21, 2023 - Termination of the Requirement for COBRE, INBRE, IDeA-CTR, and NARCH Awards to Provide Supplemental Annual Reports through the Scientific Information Reporting System (SIRS). See Notice NOT-GM-23-046
NOT-OD-22-189 -Implementation Details for the NIH Data Management and Sharing Policy
NOT-OD-22-195 -New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023
NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023
NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
The Institutional Development Award (IDeA) Networks of Biomedical Research Excellence (INBRE) program funds statewide networks of higher education and research institutions in IDeA-eligible states to build biomedical research capacity through supporting faculty research and research mentoring, student participation in research, and enhancement of institutional research infrastructure.
Not Applicable
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
June 26, 2023 | June 26, 2023 | Not Applicable | November 2023 | January 2024 | April 2024 |
May 22, 2024 | May 22, 2024 | Not Applicable | November 2024 | January 2025 | April 2025 |
May 22, 2025 | May 22, 2025 | Not Applicable | November 2025 | January 2026 | April 2026 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
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.
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.
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:
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:
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.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Only one award will be made per IDeA-eligible state.
Application budgets must not exceed $2.75 million per year in annual direct costs, excluding consortium facilities and administrative (F&A) costs. This FOA allows one-time funding of up to $250,000 in direct costs in the first year of the award for Alteration and Renovation Projects. If Alteration and Renovation costs are requested, the total application budget for the first year must not exceed $3.0 million in direct costs.
The project period is limited to five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits 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.
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:
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.
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.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Component | Component Type for Submission | Research Strategy Page Limit | Required/Optional | Minimum | Maximum |
---|---|---|---|---|---|
Overall | Overall | 12 | Required | 1 | 1 |
Administrative Core | Admin Core | 12 | Required | 1 | 1 |
Developmental Research Project Program | Project | 6 | Required | 1 | 1 |
Data Science Core | Core | 6 | Required | 1 | 1 |
Research Core | Core | 6 | Optional | 0 | 2 |
Alteration and Renovation | Alt and Renov | 6 | Optional | 0 | 1 |
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:
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.
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.
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:
The Research Strategy section must include the following sections:
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):
B. Organization: The application must provide descriptions of network institutions, components, committees, and the organizational relationship among them, including the following elements:
C. Overall goals and general strategies
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:
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
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.
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.
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.
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:
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.
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.
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.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
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.
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.
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.
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:
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.
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.
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.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
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.
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.
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.
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:
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.
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.
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.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
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.
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.
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.
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:
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.
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.
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.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
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:
This attachment should be titled Line Drawing.
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.
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.
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:
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
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.
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.
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.
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.
Scientific Needs:
Architectural Plans:
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:
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:
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.
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).
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:
Note: For Human Subjects or Clinical Trials, the grantee must enter study data in the Human Subjects System (HSS) before requesting NIGMS approval.
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:
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.
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.
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:
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: 301-480-7075
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
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.