Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• Eligible Agencies of the Federal Government

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Before submitting a fellowship application, the candidate must identify a sponsoring institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. The training should occur in an environment that has appropriate human and technical resources and is demonstrably committed to training in the field(s) proposed by the applicant. The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories. All institutions with the appropriate resources and commitment are encouraged to apply. An individual may request support for training abroad. In such cases, the candidate is required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when the scientific advantages are clear.

The Kirschstein-NRSA F32 fellowship is designed to support research training experiences in new settings in order to maximize the acquisition of new skills and knowledge. In most cases, therefore, the sponsoring institution should be a site other than where the candidate trained as a graduate student. However, if the candidate is proposing postdoctoral training at his/her doctoral institution, the application must carefully document the opportunities for new research training experiences specifically designed to broaden his/her scientific background and to acquire new knowledge and/or technical skills that will enhance his/her potential to become a productive, independent investigator. Applications that propose postdoctoral experiences in the same lab, in fundamentally the same research environment or with the same primary mentor who supported the candidate's predoctoral experience, are inconsistent with the intent of this F32 program.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the 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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 applicant fellow with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her sponsor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Applicants are strongly encouraged to apply for this funding opportunity before they have completed their terminal doctoral degree requirements, so that this fellowship award may begin early in their postdoctoral training period and maximize this award's training potential. Applications are encouraged from individuals who expect to complete their terminal doctoral degree requirements within 12 months of the application due date. On the application due date, candidates may not have completed more than 12 months of postdoctoral training, as measured from the completion of all doctoral degree requirements. If requested, applicants should be prepared to provide a letter signed by the director of their degree program and countersigned by an authorized institutional representative.

Parental leave or other well-justified leave for personal or family situations of generally less than 12 months duration (e.g., family care responsibilities, disability or illness, active military duty) is not included in the 12-month postdoctoral eligibility limit. Part-time postdoctoral research, related to personal or family situations, will be pro-rated accordingly. Potential applicants are encouraged to consult NIH scientific/research staff if they have any questions regarding their eligibility.

Applicants completing terminal doctoral degrees in quantitative disciplines, e.g., statistics, computer science, physics, mathematics, and engineering, are eligible and encouraged to apply for this FOA.

Before a Kirschstein-NRSA postdoctoral fellowship award can be activated, the individual must have received a PhD, MD, DO, DC, DDS, DVM, OD, DPM, ScD, EngD, DrPH, DNSc, ND (Doctor of Naturopathy), PharmD, DSW, PsyD, or equivalent doctoral degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree-granting institution that all degree requirements have been met is also acceptable. A Kirschstein-NRSA fellowship may not be used to support the clinical years of residency training. However, these awards are appropriate for the research fellowship years of a residency program. Research clinicians must devote full-time to their proposed research training and confine clinical duties to those activities that are part of the research training program.

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of fellowship and career development awards are encouraged to apply for an extramural LRP award.

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Individuals may not exceed the aggregate limit of NRSA support shown above in the Award Project Period (see Section II. Award Information). Candidates must consider any prior NRSA research training in determining the duration of support requested. Information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.

At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

Before submitting the application, the applicant must identify a sponsor(s) who will supervise the proposed mentored training experience. The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the applicant's research training and to direct supervision of his/her research. The sponsor must document the availability of sufficient research funds and facilities for high-quality research training. The sponsor, or a member of the sponsor team, should have a successful track record of mentorship. Applicants are encouraged to identify more than one sponsor, i.e., a sponsor team, if this is deemed advantageous for providing expert advice in all aspects of the training program. When there is a sponsor team, one individual must be identified as the primary sponsor, and will be expected to coordinate the applicant's overall training. The applicant must work with the sponsor(s) in preparing the application. Importantly, however, the proposed research project should derive from the collaborative intellectual input of the applicant fellow and sponsor(s).

For this FOA, applicants are strongly encouraged to select a primary sponsor with whom they have not collaborated during their predoctoral training period so as to maximize training potential of the award (see also Section III.1. Eligible Organizations above).

For this FOA, at least the primary sponsor should have research expertise relevant to one or more of the goals described in the BRAIN 2025 Report; however, the sponsor is not required to have direct funding from the BRAIN Initiative.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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 Fellowship (F) instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Ashlee Van't Veer, PhD
Telephone: 301-443-3107
Fax: 301-443-1731
Email: [email protected]

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed

Instructions for Application Submission

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.

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

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

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

Facilities & Other Resources: Include a description of how the scientific environment is specifically conducive to the proposed research training in one or more of the high-priority areas described in the BRAIN 2025 Report.

Other Attachments: Attach a one-page description of the relationship of the proposed Research Training Plan to one or more of the specific goals stated in the BRAIN 2025 Report. The first sentence of this description should state which of the seven, high-priority goals enumerated in this Report is addressed by your Research Training Plan. Name this file: BRAIN Relationship.

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

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

Candidate Biographical Sketch: Clearly indicate the anticipated or actual date (month and year) doctoral degree requirements will be/were completed.

Sponsor(s) Biographical Sketch: As part of the Personal Statement, describe research expertise relevant to the goals of the BRAIN Initiative and the candidate's proposed research training plan.

IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (fellowship applicant) must include an 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.

The PHS Fellowship Supplemental Form is comprised of the following sections:

• Fellowship Applicant
• Research Training Plan
• Sponsor(s), Collaborator(s), and Consultant(s);
• Institutional Environment & Commitment to Training
• Other Research Training Plan Sections
• Additional Information
• Budget
• Appendix

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

Fellowship Applicant Section

Applicant s Background and Goals for Fellowship Training

Describe your current and prior research experience, making clear how it is distinguished from the proposed research training and how it has prepared you for the proposed project. Describe the planned activities that will provide you with a strong foundation in quantitative reasoning, research design, methods, statistics and analytic techniques appropriate to the proposed research. Make clear how the training goals and planned activities will contribute to development of the technical skills, conceptual approaches, scientific knowledge, and professional skills needed for you to contribute to advancing the goals of the BRAIN 2025 Report, and to transition to the next stage of your research career.

Identify the skills, theories, conceptual approaches, etc., to be learned or enhanced during the award, including, as applicable, expertise in rigorous research design, experimental methods, quantitative approaches, and data analysis and interpretation, as applicable

Research Training Plan

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

Research Strategy

Relate the proposed project to the BRAIN Initiative. Given that this FOA is intended for early postdoctoral research training, it is not expected that applicants will include their own preliminary results. However, applicants are encouraged to address technical feasibility; document previously published work that supports the proposed project and technical approaches; describe potential pitfalls; and describe alternative approaches should the proposed approach not prove viable.

If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, describe the relationship of the proposed research project to the clinical trial.

Explain the importance of the problem or critical barrier to progress that the proposed project addresses.

Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.

Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.

Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Selection of Sponsor and Institution

Relate the rationale/justification for the selection of the sponsor and institution to the goals of the BRAIN Initiative.

Sponsor(s), Collaborator(s), and Consultant(s)

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

Sponsor and Co-Sponsor Statements

The Sponsor and any Co-Sponsors should describe their qualifications to train a postdoctorate who seeks mentored training in a research area relevant to the goals of the BRAIN Initiative. State how the proposed mentored training provides a new research direction for the candidate and how it provides a foundation for a research career relevant to the goals of the BRAIN Initiative. Document a detailed plan of mentored research training, including any necessary didactics to ensure that the applicant acquires robust grounding in experimental design, statistics, and other analytical tools appropriate for the proposed research area; and mentored professional development. Provide a milestone-driven timeline to assess the applicant's progress during the award period, and describe how any necessary guided course-correction will be achieved to ensure that the applicant makes strong progress toward the proposed research and career development goals. Describe a specific plan by which the applicant's transition to the next step of his/her research career will be facilitated during this fellowship award. Describe a plan for clear separation of the candidate's research and research career from the sponsor's research, including identifying the components of the research plan that the candidate may take.

Letters of Support from Collaborators, Contributors, and Consultants: It is expected that collaborators and consultants will provide a letter that describes and confirms their commitment and role in the project.

Institutional Environment and Commitment to Training Section

Description of Institutional Environment and Commitment to Training

Describe the institutional opportunities available to the applicant to develop professional skills, e.g., communication skills, grant-writing skills, laboratory management, leadership, and preparing future faculty. Describe the contribution of the sponsor and sponsor's research environment to development of these skills, and describe the opportunities available to the applicant that are independent of the sponsor.

Appendix

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

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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 with the following additional instructions:

Section 3 - Protection and Monitoring Plans

3.1 Protection of Human Subject

Applications with data collection plans that involve 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 updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (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.

Do not provide an NCT# in Section 1, item 1.5. See instruction for Sponsor(s), Collaborator(s), and Consultant(s) in the SF424 (R&R) Application Guide.

Do not complete Section 4 Protocol Synopsis information or Section 5 Other Clinical Trial-related Attachments.

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.

Applicants must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Reference Letter link and not through Grants.gov.

Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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). 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.

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. The National Research Service Award (NRSA) policies apply to this program. A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Pre-award costs are generally not allowable for Fellowships.

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:
All PD(s)/PI(s) and sponsor(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

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

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:

• A fellowship application has a research project that is integrated with the training plan. The review will emphasize the candidate s potential for a productive career, the candidate’s need for the proposed training, and the degree to which the research project and training plan, the sponsor(s), and the environment will satisfy those needs.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the candidate s potential for, and commitment to, a productive independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

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.

Fellowship Applicant

• Are the candidate’s academic record and research experience of high quality?
• Does the candidate have the potential to develop into an independent and productive researcher?
• Does the candidate demonstrate commitment to a research career in the future?
• Does the research project reflect a significant contribution of the candidate to the originality of the project idea, approach and/or hypotheses?
• Has the applicant been appropriately productive during the predoctoral training period?

Sponsors, Collaborators, and Consultants

• Are the sponsor(s ) research qualifications (including recent publications) and track record of mentoring individuals at a similar stage appropriate for the needs of the candidate?
• Is there evidence of a match between the research and clinical interests (if applicable) of the candidate and the sponsor(s)? Do(es) the sponsor(s) demonstrate an understanding of the candidate’s training needs as well as the ability and commitment to assist in meeting these needs?
• Is there evidence of adequate research funds to support the candidate s proposed research project and training for the duration of the research component of the fellowship?
• If a team of sponsors is proposed, is the team structure well justified for the mentored training plan, and are the roles of the individual members appropriate and clearly defined?
• Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed project? Were letters provided by collaborators and consultants that describe and confirm their commitment to the project?
• If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, is there evidence of the appropriate expertise, experience, resources, and ability on the part of the sponsor(s) to guide the applicant during the clinical trial research experience?
• Does the sponsor's mentoring statement, as well as their training record, indicate that the candidate will receive outstanding mentored training in the proposed research area, in methodology relevant to the project, experimental design, and analytical skills including quantitative skills as appropriate for the proposed project?
• Does the sponsor(s) have appropriate expertise to guide the candidate in high-quality research training that is relevant to the goals of the BRAIN Initiative?
• Does the primary sponsor provide a new direction for the candidate's research training, with no history of prior collaboration with the applicant?
• Does the sponsor provide a milestone-driven timeline to assess the candidate's progress during the award period, and a plan to facilitate the applicant's transition to the next step in his/her research career?
• Does the sponsor describe an acceptable plan for clear separation of the candidate's research and research career from the sponsor's research, including identifying the components of the research plan that the candidate may take to an extramural research position?

Research Training Plan

• Is the proposed research project of high scientific quality, and is it well integrated with the proposed research training plan?
• Based on the sponsor’s description of his/her active research program, is the candidate’s proposed research project sufficiently distinct from the sponsor’s funded research for the candidate’s career stage?
• Is the research project consistent with the candidate’s stage of research development?
• Is the proposed time frame feasible to accomplish the proposed training?
• Does the training plan provide adequate opportunities to present and publish research findings and meet with scientists in the community at national meetings as the work progresses?
• Will the training plan provide the professional skills needed for the candidate to transition to the next stage of his/her research career?
• Does the discussion of expected results, and potential pitfalls and alternative outcomes provide confidence that, if an important component of the research is unsuccessful, the applicant is likely to have a viable direction for continuing the project?
• If proposed, will the clinical trial experience contribute to the proposed project and/or the applicant’s research training?
• Is the prior research that serves as the key support for the proposed project rigorous?
• Has the applicant included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
• Has the applicant presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the applicant presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Training Potential

• Are the proposed research project and training plan likely to provide the candidate with the requisite individualized and mentored experiences in order to obtain appropriate skills for a research career?
• Does the training plan provide needed skills and address gaps in the candidate's training?
• Does the training plan document a clear need for, and value of, the proposed training?
• Does the proposed training have the potential to serve as a sound foundation that will clearly enhance the candidate’s ability to develop into a productive researcher?
• Does the proposed research training occur in an area that clearly complements the applicant's doctoral research training?
• Is the proposed training likely to ensure that the applicant gains robust analytical skills including quantitative reasoning, experimental design, statistics and other analytical tools appropriate for the research area?
• Is the proposed training, including professional skills development, likely to help prepare the applicant to launch an independent research career?

Institutional Environment & Commitment to Training

• Are the research facilities, resources (e.g., equipment, laboratory space, computer time, subject populations), and training opportunities (e.g. seminars, workshops, professional development opportunities) adequate and appropriate?
• Is the institutional environment for the candidate’s scientific development of high quality?
• Is there appropriate institutional commitment to fostering the candidate s mentored training?
• Is the institutional environment appropriate for postdoctoral training using cutting-edge neuroscience tools and technologies?
• Does the institutional and/or laboratory environment provide appropriate and sufficient opportunities for the applicant to gain the professional skills needed for a successful research career?

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Allowed

Revisions

Not Allowed

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.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for Instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the sponsor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIMH 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:

• May undergo a committee 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.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned 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 National Advisory Mental Health Council. The following will be considered in making funding decisions:

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

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.

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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.

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

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

As specified in the NIH Revitalization Act of 1993, Kirschstein-NRSA recipients incur a service payback obligation for the first 12 months of postdoctoral support. Policies regarding the Kirschstein-NRSA payback obligation are explained in the NIH Grants Policy Statement; applicants may also wish to review Frequently Asked Questions for more details. The taxability of stipends is described in the NIH Grants Policy Statement.

Fellowships funded primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required. More details, including exceptions for fellows training at NIH are provided in the NIH Grants Policy Statement.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

• Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.
• The fellowship award recipient has up to six months from the issue date on the Notice of Award to activate the award using the Kirschstein-NRSA Individual Fellowship Activation Notice (PHS 416-5). Under unusual circumstances, the activation period may be extended at the request of the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.
• For the individual's initial 12 months of Kirschstein-NRSA postdoctoral support, a signed, original Payback Agreement Form (PHS 6031) must accompany the Activation Notice.
• At the conclusion of a fellowship, the fellow must submit a Termination Notice (PHS 416-7) via xTrain to the NIH within 30 days of termination. Fellows with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

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

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: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-637-3015

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

Ashlee Van't Veer, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3107
Email: [email protected]

Nick Gaiano, PhD

National Institute of Mental Health (NIMH)

Telephone: 301-827-3420

Email: [email protected]

Craig Winters
National Institute of Mental Health (NIMH)
Telephone: 301-451-9948
Email: [email protected]

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 Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.