National Institutes of Health (NIH)
NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH)
P50 Specialized Center
See Section III. 3. Additional Information on Eligibility.
This notice of funding opportunity (NOFO) encourages applications for Silvio O. Conte Centers for Basic Neuroscience or Translational Mental Health Research. The National Institute of Mental Health (NIMH) seeks teams of integrative researchers working at different levels of analysis and employing novel, and creative experimental approaches to address high-risk, high-impact questions with the primary objectives of: (a) advancing basic brain and behavior research that will uncover underlying mechanisms that could provide the foundation for understanding mental disorders; (b) supporting the integration and translation of basic and clinical neuroscience research on severe mental illnesses; (c) advancing our understanding of the neurobehavioral mechanisms and trajectories of psychopathology that begin in development. This program is intended only for projects that could not be achieved using other, more standard grant mechanisms.
The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| October 15, 2026 | October 15, 2026 | Not Applicable | March 2027 | May 2027 | July 2027 |
| May 25, 2027 * | May 25, 2027 * | Not Applicable | November 2027 | January 2028 | April 2028 |
| May 25, 2028 * | May 25, 2028 * | Not Applicable | November 2028 | January 2029 | April 2029 |
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 How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
The Conte Centers program seeks highly meritorious applications focused on a well-defined and unified scientific question (hypothesis) or problem. A Conte Center application does not need to include both basic neuroscience and translational research; however, it should comprise a collaborative, cutting-edge, multidisciplinary research program that would be difficult to undertake within the confines of a single laboratory or a small-scale collaboration.
Research topics may include any aspect of basic genetics and neuroscience related to cognitive, affective, or social function of the brain and can be conducted at multiple levels of analysis involving genes, cells, synapses, circuits, and behavior, in healthy and/or disease states, in model systems or humans, and from the prenatal period throughout the lifespan. Center projects may also include translational integration of neuroscience to address clinical questions in humans to identify the etiology, pathophysiology, developmental trajectory, potential biomarkers, and/or the mechanistic substrates of interventions with the goal of eventual prevention, treatment, and cure of mental disorders across the lifespan. Discovery-based as well as technology development components in support of the primary scientific question are welcomed. Important features of Conte Centers should include interdisciplinary research training opportunities for future biomedical scientists, and the widespread sharing of replicable, reproducible and generalizable data, as well as newly-developed methods and resources to the community. Thus, the Conte Centers program provides a unique opportunity to address one or more of the NIH priorities and NIMH strategic plan.
General characteristics of Conte Centers are listed below:
In addition to considering the strengths and weaknesses of the scientific premise that form the basis for the questions asked, the application should be constructed to enhance reproducibility through scientific rigor (Guidance: Rigor and Reproducibility in Grant Applications | Grants & Funding).
Student and Postdoctoral Research Experiences
It is expected that the Conte Centers will train future biomedical scientists by providing students and postdoctoral fellows opportunities for interdisciplinary research in close coordination with existing formal research training programs at the participating institution(s). As part of the Administrative Core, the Conte Center should provide opportunities for individuals to become engaged in the innovative interdisciplinary collaborative interactions driving the Center's research objectives and to obtain a broad, multidisciplinary perspective in the Conte Center research area.
Communication and Outreach
As part of the Administrative Core, Conte Centers should include a communications element that includes a website, public outreach, and dissemination activities. Encouraged outreach activities may include Conte Center-focused partnerships with local school systems, science museums, or related institutions. These activities may involve the participation of Conte Center investigators in special lectures or laboratory demonstrations as part of ongoing outreach programs, such as Brain Awareness Week and National DNA Day. Visits from classroom groups would also be appropriate to include as an outreach activity.
Conte Centers are encouraged to develop and maintain a website for a broad audience that describes the Conte Center and how the research supported by the Center will advance our understanding of the biology of mental disorders.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
See Section VIII. Other Information for award authorities and regulations.
Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.
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.
Direct costs are limited to $2 million in any one year.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organization) 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 How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
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. Obtaining an eRA Commons account can take up to 2 weeks.
All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.
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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
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 NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
| Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
|---|---|---|---|---|---|
| Overall | Overall | 12 | Required | 1 | 1 |
| Admin Core | Admin Core | 6 | Required | 1 | 1 |
| Project | Project | 6 | Required | 3 | NA |
| Research Support Core | Core | 6 | Optional | 0 | 3 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
The application should consist of the following components:
Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed above may not apply to the revision applications.
When preparing the application, use Component Type 'Overall'.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Follow standard instructions.
Follow standard instructions.
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 NOFO) 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.
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 and Revision applications, an Introduction to Application is required in the Overall component.
Specific Aims:
Provide a concise description of the overall Center aims. Outline how the projects and core(s) will contribute to attaining the Center objectives.
Research Strategy:
The Research Strategy should begin with a brief overview of the Center describing the scientific problems being addressed, the integration of the Center components, and why these components are essential for accomplishing the goals of the overall Center. The overview should be targeted to a broad audience and be concise. The overview should include:
1. An explanation of how the proposed work uses multiple approaches and experimental systems to cross traditional disciplinary boundaries to address a well-defined hypothesis or question.
2. For the basic neuroscience centers, an explanation of the timeliness and the potential importance and relevance of the proposed research to advancing our understanding of the fundamental mechanisms of brain development, function, gene regulation, or behavior; or preclinical approaches to treatment development, or computational approaches to understanding these mechanisms. For the translational centers, an explanation of how the proposed work integrates component projects (basic, preclinical or clinical) with translational concepts to advance our understanding of disease etiology and/or treatment of mental health disorders. If a clinical trial is proposed, cite prior relevant trials or systematic reviews that would help to justify why this trial is needed. Mental health disorders of interest to NIMH include depression, bipolar disorder, post-traumatic stress disorder, anxiety, schizophrenia, obsessive compulsive disorder, autism spectrum disorders, and other developmental disorders. NIMH is particularly interested in understanding fundamental brain changes that occur during sensitive periods of brain development and periods of increased vulnerability to psychopathology.
3. Value added by the interdisciplinary Center approach. This section should address why the proposed research justifies a Center and should include a description of the contribution of each of the projects and cores in achieving the Center's major objectives, a description of how the Center as a whole will benefit from interdisciplinary interactions, an explanation of why this work cannot be accomplished outside of this funding opportunity, and why the whole is significantly better than the sum of its parts. The section should also address how the Center will ensure appropriate prioritization of research, and identify problems, resolutions, and (if needed) course corrections.
4. If a scientific project or core involves risk, applicants should explain how the degree of risk will be counterbalanced by the benefits to be gained and how these benefits will impact the science in relation to the state-of-the-art of the field. Applicants should also explain potential threats (if any) to data integrity and how these threats might affect the feasibility of the proposed research.
5. In this section, applicants should address the strengths and weaknesses of the scientific premise forming the basis of their questions and enhancing reproducibility through rigor (see: NOT-MH-14-004).
The Research Strategy should also include:
1. Preliminary Data: This section should include evidence for feasibility and preliminary findings and/or progress made during the previous funding period. This section should also present very clear evidence that the research team will be able to work together effectively to accomplish the research proposed in the projects.
2. Center Approach: This section should describe the working scientific and logistical design, as well as the resource support necessary to implement the research, demonstrating how the Center mechanism will serve to enhance the individual projects proposed. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements to facilitate communication and collaboration across the sites should be included. Institutional support, if any, should be described in this section.
3. Timeline, Milestones, Evaluation Plan and Advisory Board: A graphic Overall Center Timeline and a descriptive Milestones section for the overall Center must be included in the Research Strategy section for the Overall Center. Milestones should be identified along the timeline. Milestones should be well described, quantifiable, and scientifically justified benchmarks at critical junctures as well as annual indicators of progress. This section should also include specific proof-of-concept test(s) along with any alternative strategies should any component efforts fail to perform as expected. This Overall Center Timeline is separate from the Study Timeline in section 2.7 of the PHS Human Subjects and Clinical Trials Form. The Overall Center Timeline should include the establishment of a to-be-named external scientific board to be convened annually to assess progress and accomplishments and provide feedback to the Center. It is very important that potential external scientific board members not be contacted or identified in the application to minimize conflicts during the application review process and so that all individuals with appropriate scientific expertise remain eligible for consideration. External scientific board members should only be identified after a funding decision is made.
Progress Report (For Renewal Applications):
Additional Instruction for Multi-project:
If you include a Progress Report Publication List attachment, include it in either the Overall Component or within each Other Component, but do not attach the same information in multiple locations.
Protection of Human Subjects:
Applications with data collection plans that involve human participants, including multiple respondent groups (e.g., clients/patients, therapists/providers, supervisors, administrators) should address provisions for human subject protections and consenting procedures for all participant groups, accordingly. The NIMH has published policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (see NOT-MH-19-027). The application's Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.
Letters of Support:
Include letters of support relevant to the overall Center here. Letters detailing contributions to individual components should be placed in their respective individual Project or Core component. When multiple institutional sites are involved, a letter of support should be included that details the description of the cooperative administrative arrangements.
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Other Plan(s):
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
To advance the goal of advancing research through widespread data sharing among researchers, investigators funded by NIMH under this NOFO are expected to share those data see NOT-MH-23-100). Established by the NIH, NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to NDA.
To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. For more guidance on submitting data to NDA, refer to the NDA Data Management and Sharing Plan on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, 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 How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset studies are not permitted for Conte Centers.
All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type 'Admin Core.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Follow application instructions.
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 will be included in the application package.
Each proposed Center Director must commit a minimum effort of 3 person months per year overall to the Center and be a leader of one of the projects and of the administrative core. The 3 person months should be a total of the Center Director's efforts on his/her project(s) and core(s). The 3 person month requirement also applies to any individual listed as a PD/PI in a multiple PD/PI Center.
The Administrative Core Leader must commit a minimum effort of 1 person month per year to the core. If there are multiple leaders for the Administrative Core, the combined efforts of the identified Administrative Core Leaders must total 1 person month.
The Administrative Core budget should include costs for:
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 and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims: Provide a concise description of the goals of the Administrative Core.
Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support multidisciplinary systems biology research, student and postdoctoral research infrastructure and outreach, to foster synergy, and to support planning and evaluation activities. Provide a clear and detailed plan for managing the Center's research and administration.
Highlight features of the Administrative Core that will enhance the collaborative effort, including optimizing communication, decision-making and sharing between the Project and/or Scientific Core teams.
Describe how each Project or Scientific Core (as applicable) will draw upon the Administrative Core and how it in turn will respond to Project or Research Support Core needs. The description of the Administrative Core should clearly indicate the facilities, resources, services and professional skills that the Core will provide. Moreover, information must be provided about how the collective operation of the Core will be achieved in a coherent manner.
Additional information is encouraged:
Public Outreach/Dissemination Plan: Outreach and dissemination activities that will inform the public about Conte Center activities and enhance science literacy should be described in this section.
Letters of Support: Include letters of support relevant to the administrative core.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- 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 How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Delayed Onset studies are not permitted for Conte Centers.
When preparing your application, use Component Type 'Project.'
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Follow application instructions.
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.
Application guide states that Project Narrative is required. However, it is only required for the Overall component
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 will be included in the application package.
Leaders of a Project must commit a total minimum effort of 1.8 person months per year to each project. Multiple project leaders are allowed for Projects. If there are multiple leaders on a Project, the combined efforts of the identified project leaders must total 1.8 person months per year per Project.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.
Specific Aims: List the specific objectives of the proposed research.
Significance: Describe the overall goals and how the science proposed in the project will advance the state-of-the-art of the field. This section should also explain the contribution of the project to the overall goals of the Center, how the project will interact with and benefit from other components of the Center and the appropriateness of the center approach and environment.
Innovation: Describe the unique and innovative contributions that will be made by this project. Explain how these contributions will synergize with the rest of the Center to achieve more than what could be achieved through an independent research project.
Approach: Describe the feasibility of the proposed experiments, the advantages of any new methodologies, the potential pitfalls, and alternative approaches for the project and how these might impact progress in the overall Center.
Environment: Describe the scientific environment in the context of anticipated interactions between this project and other components of the Center and anticipated progress in the overall Center.
Letters of Support: Include letters of support relevant to the project.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- 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 How to Apply- Application Guide, with the following additional instructions:
If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Section 2 - Study Population Characteristics
2.7 Study Timeline
Applicants should include a section on Sample Subject Timeline. Address the time it will take for an individual participant to complete all study visits. When possible provide a brief snapshot of the protocol's schedule of events capturing time points and planned activity at study visits. For example:
Applicants should address the Study Duration. Include the estimated time (in months) from when the study opens to enrollment until: (a) completion of data collection; and (b) final data analyses.
Applicants are required to provide detailed project performance and timeline objectives. This section must include an overview of the project timeline for the following general milestones, as applicable:
These milestones will be negotiated at the time of the award, as appropriate.
Section 3 - Protection and Monitoring Plans
3.1 Protection of Human Subjects
The description of the study population should address demographic group, required health status, and geographic location.
Describe methods and systems to ensure data confidentiality and subject privacy.
3.3 Data and Safety Monitoring Plan
Describe the locations where the monitoring will occur (e.g., participating clinical sites, data center, clinical coordinating center) and what data will be reviewed.
Provide an overall description of the monitoring plan to ensure adherence to the protocol, and the quality and consistency of the study intervention(s), including fidelity monitoring for behavioral interventions. Include methods to monitor study intervention and system to record and manage exceptions and deviations. If applicable, describe monitoring of participating facilities, such as labs or pharmacies, for adequate handling and storage of investigational product(s) and study specimens. Include a description to ensure that the investigational product(s) accountability and reconciliation are performed adequately during and at the end of the trial per applicable regulatory requirements.
Describe plans for handling any deficiencies that are uncovered, and in cases of serious deficiencies, the appropriate reporting to relevant authorities, including but not limited to the IRB of record, DSMB if one is assigned, FDA if applicable, institutional officials, and the NIH.
Describe methods and systems for data collection (e.g., Case Report Forms/CRFs), data entry, data verification, and data validation. Describe the data query process and frequencies and any planned mitigation strategies in the event of noncompliance.
Describe the process for locking the final trial datasets and the planned procedures on data access and sharing, as appropriate.
Section 4 - Protocol Synopsis
4.1 Brief Summary
NIH recognizes the role of both effectiveness/pragmatic versus efficacy trials and understands that all elements will not apply to all trial types (e.g., frequent patient visits, 100% source data verification, frequent site monitoring) for example for large simple effectiveness trials. Applicants should ensure applicable elements are provided based on the type of trial planned (e.g., efficacy, effectiveness, randomized registry or pilot trials).
4.2 Study Design
4.2.c Interventions
If applicable, provide a description of the dose frequency and type of administration of the intervention(s).
4.6 Will the study use an FDA-regulated intervention?
4.6.a If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status
If applicable, provide FDA info available on early feasibility studies.
Section 5 - Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-related Attachments
The following additional Clinical Trial-related attachments are required for applications that include a clinical trial: "Common Data Elements Applicability" and "Clinical Protocol Schedule of Events."
Common Data Elements Applicability
Applicants are required to provide a description of their plans to consider the applicability of Common Data Elements (CDEs). The filename "Common Data Elements Applicability.pdf" must be used for this attachment. If more than one set of CDEs are used, they should be combined in this attachment.
Investigators are encouraged to describe if NIH-supported CDEs will be used in the proposed clinical trial. If CDEs are not applicable, applicants are expected to explain why.
Clinical Trial applications that lack the 'Common Data Elements Applicability' attachment are considered incomplete.
Clinical Protocol Schedule of Events
The filename "Clinical Protocol Schedule of Events.pdf" must be used for this attachment. If more than one set of Clinical Protocol Schedules of Events are used, they should be combined in this attachment.
The clinical protocol schedule of events is to capture a snapshot of the time it takes for protocol procedures to be completed by an individual participant during the trial.
For example:
This document may be provided in a tabular format.
Clinical Trial applications that lack the 'Clinical Protocol Schedule of Events' attachment are considered incomplete.
Labeling information or summary of safety information from prior studies may be attached for a clinical trial testing a significant risk investigational device for which an application for a new Investigational Device Exemption (IDE) will be submitted.
Delayed Onset Study
Delayed Onset studies are not permitted for Conte Centers.
When preparing your application in ASSIST, 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 Support Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Research Support Core)
Follow application instructions.
Research & Related Other Project Information (Research Support 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 description of the Research Support Core should indicate how its facilities, resources, services, and professional skills will be leveraged to provide services to the proposed center.
Project /Performance Site Location(s) (Research Support 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 Support Core)
Budget (Research Support Core)
Budget forms appropriate for the specific component will be included in the application package.
Leaders of Research Support Cores must commit a minimum effort of 1 person month per year to the Research Support Core. Multiple leaders are allowed for Research Support Cores. If there are multiple leaders, the efforts of the identified leaders must total 1 person month per year per core.
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 Support Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Provide a concise description of the goals of the Research Support Core. Explain how the Research Support Core will contribute to attaining the Center objectives.
Research Strategy: A Research Support Core can be a laboratory, facility, service, or other shared resource that supports other Center components in their activities. Descriptions for the core should include a brief overview and a description of the services and resources to be provided to other Center components. This section should address how the core will contribute to the overall goals of the Center as well as which projects will be supported by the Research Support Core and the manner in which that support will be rendered by the core. Issues to be addressed include: qualifications, past performance (if applicable), and time commitments of the Research Support Core Leader(s), quality control, procedures for selecting projects that use the Research Support Core, cost effectiveness, and increased efficiency. Provide evidence that appropriate expertise will be available to carry out the functions proposed for each core. While scientific activities per se are not an essential part of a Research Support Core, quality assurance activities that evaluate its operations, conceptual design, methods, and analyses, and are directed at problem identification and improvement of core functioning are appropriate.
Letters of Support: Include letters of support relevant to the Research Support Core.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. All information about Resource Sharing Plans should be consolidated in the Administrative Core section of the application.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information (Research Support 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
Delayed Onset studies are not permitted for Conte Centers.
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a "Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
NIMH expects investigators for this funding announcement to collect Common Data Elements (CDEs) for mental health human subjects research. Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications involving human research participants. The necessary funds for collecting and submitting these CDE data from all research participants should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs. NIMH may seek further information regarding CDEs prior to award. Additional information about CDEs can be found at the NIMH webpage on Data Management and Sharing for Applicants and Awardees and NOT-MH-25-055.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this NOFO:
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this NOFO:
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this NOFO:
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO:
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Specific to this NOFO:
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Specific to this NOFO:
Center Components: Individual Center Components (Administrative Core, Projects, and Research Support Cores) will be assessed for relevant strengths and weaknesses in the context of the Overall Center but will not be given individual scores.
Additional Review Criteria - Administrative Core:
Additional Review Criteria - Projects
Additional Review Criteria - Research Support Cores
Milestones
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
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.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
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.
For Resubmissions (as applicable), the 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.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
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).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
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.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by CSR, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
The NIMH has published policies and guidance for investigators regarding human research protection, data and safety monitoring, Independent Safety Monitors and Data and Safety Monitoring Boards, reportable events, and participant recruitment monitoring (NOT-MH-19-027). The application's PHS Human Subjects and Clinical Trials Information should reflect the manner in which these policies will be implemented for each study record. These plans will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. The NIMH will expect clinical trials to be conducted in accordance with these policies including, but not limited to: timely registration to ClinicalTrials.gov, submission of review determinations from the clinical trial's data and safety monitoring entity (at least annually), timely submission of reportable events as prescribed, and establishment of recruitment milestones and progress reporting.
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: Recipient organizations 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).
Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy."
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Cybersecurity plans and procedures must at minimum include the following:
All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings. Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety. If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.
For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.
For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on MAT/MOUD.
As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.
In administering programs under this and all funding announcements, NIH prioritizes:
Not Applicable
A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
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.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
National Institute of Mental Health (NIMH)
Division of Neuroscience and Basic Behavioral Science (DNBBS)
Email: DNBBSinitiatives@mail.nih.gov
Division of Translational Research (DTR)
Email: DTRcommunications@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
National Institute of Mental Health (NIMH)
Grants Management (NOFOs)
Email: NIMHNOFOGrantsManagement@mail.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 2 CFR Part 200.