November 7, 2017
February 15, 2018
30 days prior to the application due dates
March 15, 2018; December 7, 2018; August 7, 2019; April 7, 2020, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates
No late applications will be accepted for this Funding Opportunity Announcement.
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.
July 2018, March 2019, November 2019, July 2020
Not Applicable for Fellowships
September 2018, July 2019, April 2020, September 2020
April 8, 2020
It is critical that applicants follow the Fellowship (F) instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NRSA fellowships support the training of pre-and postdoctoral scientists, dual-degree investigators, and senior researchers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.
The purpose of the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (F32) is to support promising applicants during their mentored postdoctoral training under the guidance of outstanding faculty sponsors. Applicants for the BRAIN Initiative Fellows F32 program are expected to propose a research project and training plan in a scientific area relevant to one or more of the goals of the BRAIN Initiative, including neuroethics (see http://braininitiative.nih.gov). The integrated program of research and training is expected to provide applicants with training using cutting-edge tools, theories and/or approaches that will prepare them to launch independent research careers in areas that will advance the goals of the BRAIN Initiative. See the section, Specific Objectives of this FOA, below for details.
The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat and prevent brain disorders.
NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, "BRAIN 2025: A Scientific Vision," which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This FOA and other FOAs issued in Fiscal Year 2018 are based on careful consideration by the NIH of the recommendations of the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group. Videocasts of the NIH BRAIN Multi-Council Working Group are available at http://www.braininitiative.nih.gov/about/mcwg.htm.
In addition to the National BRAIN initiative, the NIH continues to have a substantial annual investment in neuroscience research and research training. The Institutes and Centers contributing to the NIH BRAIN Initiative (http://braininitiative.nih.gov/) support those research and research training efforts through investigator-initiated applications as well as through specific FOAs. Potential applicants to this FOA are strongly encouraged to contact Scientific/Program staff if they have any questions about the best FOA for their research training.
To enable rapid progress in development of new technologies as well as in theory and data analysis, the BRAIN Initiative encourages collaborations between neurobiologists and scientists from statistics, physics, mathematics, engineering, and computer and information sciences; and NIH welcomes applications from investigators in these disciplines.
NIH encourages BRAIN Initiative applications from investigators who are underrepresented in the biomedical, behavioral, or clinical research workforce (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). Such individuals include those from underrepresented racial and ethnic groups and those with disabilities (see NOT-OD-15-053).
The BRAIN Initiative will require a high level of coordination and sharing between investigators. It is expected that BRAIN Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings and in other activities.
Educational goals for the NIH component of the BRAIN Initiative (see BRAIN 2025: A Scientific Vision) include acquisition of quantitative skills, the appropriate use and integration of newly developed tools, technologies and methods developed under the BRAIN Initiative, and consideration of the ethical implications of neuroscience research.
The BRAIN 2025 Report notes that individuals should obtain robust grounding in quantitative reasoning, principles, and techniques during their training. A special focus is training in quantitative neuroscience, i.e. theory and statistics for biologists, and exposing physicists, engineers and statisticians to experimental neuroscience. The BRAIN 2025 Report strongly encourages scientists to cross traditional areas of expertise to conduct interdisciplinary research, and acknowledges the need to attract investigators and faculty recruits to neuroscience from quantitative disciplines, e.g., statistics, computer science, physics, mathematics, and engineering.
The BRAIN 2025 Report emphasizes the need to consider the ethical implications of neuroscience research. In human neuroscience research, unique ethical issues are arising because new neurotechnologies are being employed that affect the human brain. In addition to grounding all neuroscience research training in consideration of ethical issues, it is necessary to invest in training
individuals who will be the next generation of leaders in neuroethics research. For this reason, this FOA encourages applications from individuals interested in obtaining postdoctoral training on the ethical implications of recent advancements in neurotechnology and brain science that are relevant to the BRAIN initiative (see BRAIN Initiative RFA MH-18-500).
This FOA is related to the education recommendations in Section II.7 of the BRAIN 2025 Report. Specifically, this FOA solicits applications from early-stage postdoctorates to acquire mentored research training using cutting-edge tools, theories and/or approaches in one of the seven, high-priority areas of the BRAIN Initiative including neuroethics. Given the expressed need to bring those trained in quantitative disciplines to neuroscience research, applications from individuals obtaining terminal doctorates in quantitative disciplines are encouraged.
For BRAIN Initiative awards to date, see http://www.braininitiative.nih.gov/funding/fundedAwards.htm.
The integrated program of research and training supported by this FOA is intended for postdoctorates who are early in their postdoctoral training period in a given laboratory or research environment, rather than for advanced postdoctorates. Support for early postdoctoral training will maximize the training potential of this fellowship award. Given the interval when applications will be accepted (from 12 months prior to completing terminal degree requirements to 12 months after starting postdoctoral training), it is recognized that some applicants are unlikely to have had the opportunity to generate preliminary data for the proposed project. Accordingly, it is expected that there will be no preliminary data in the application, although inclusion of preliminary data is permissible.
The proposed research and training plan should focus on a research area and/or skill set that clearly and strongly complements the applicant's existing research expertise and skills and that will markedly broaden the applicant's knowledge and skills. For example, an applicant with existing skills in molecular neuroscience might propose a research training plan that emphasizes circuit-level neuroscience approaches to brain function. An applicant with existing neuroscience training might propose a research training plan that emphasizes neuroethics. An applicant trained in physics or statistics might propose a research training plan that emphasizes data-intensive/computational approaches to neuroscience. An applicant with research experience using non-human vertebrate animals might propose a research training plan using human subjects.
The application should consist of a well-conceived scientific project, integrated with a comprehensive training plan, which is designed by a collaborative discussion between the applicant fellow and sponsor. In addition to preparing the candidate to be a subject matter expert in the proposed research area and to acquire new technical skills, the research and training plans are expected to provide the candidate with a strong understanding of the principles of experimental design and the tools for rigorous analytical approaches. Given that neuroethics research may involve analysis of large qualitative data sets, applicants proposing research in this domain are expected to propose didactics and training that will develop state-of-the-art analytical skills appropriate for such data sets. In contrast, applicants proposing experimental neuroscience research and/or modeling are expected to propose didactics and training that will enable them to develop state-of-the-art quantitative skills, the principles of quantitative analysis, and to incorporate quantitative approaches that are appropriate to answer the proposed research question. Applicants proposing a computational/modeling project are encouraged to gain exposure to the biological approaches from which the data sets they'll model are derived.
Further, the proposed research and training plan should enhance the individual's potential to develop into a productive, independent researcher by providing committed mentorship, appropriate training and career development opportunities, and strong institutional support. The training plan should document the need for, and the anticipated value of, the proposed mentored training in relationship to the individual's research career goals and the individual's prior research training. The training plan should be explicitly designed to prepare the fellow to transition to the next stage of his/her research career.
It is expected that the mentored training experience will provide:
To be considered responsive to this FOA, the proposed research training plan must be relevant to the scientific goals of the BRAIN 2025 Report, as described in the required Other Attachment for this application (see Section IV.2. SF424(R&R) Other Project Information below). Applications that are not relevant to one or more goals of the BRAIN 2025 report will not be reviewed.
Applicants are strongly encouraged to consult with NIH scientific/research staff when planning an application. Early contact provides an opportunity for NIH scientific/research staff to provide guidance on program scope and appropriateness of the proposed research and training for potential funding in response to this FOA. Applicants should contact NIH scientific/research staff as early as possible before the due date.
A technical assistance webinar will be held for potential applicants on Tuesday, December 12, 2017 at 1:00-2:30pm EST. The intent of the webinar is to provide an overview of the FOA and to address questions pertinent to preparing an application. Participation in the webinar, although encouraged, is optional and is not required for application submission. To obtain access information, please email BRAIN.Initiative.Training@nih.gov at least 48 hours prior to the scheduled webinar and specify "BRAIN F32 webinar" in the subject line of the email. Access information will be sent the day before the webinar. Prospective applicants are encouraged to submit their questions or comments regarding the FOA to Brain.Initiative.Training@nih.gov at least 48 hours prior to the scheduled webinar. Please indicate "BRAIN F32 Webinar" in the subject line of your email.
Note: This Funding Opportunity Announcement (FOA) does not allow applicants to propose to lead an independent clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose independent clinical trials.
Note: Applicants may propose to gain experience in a clinical trial led by a sponsor/co-sponsor as part of their research training.
The BRAIN Initiative intends to commit $1.3M per year in fiscal years 2018-2020 to fund an estimate of 20 awards per year.
Award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.
Individuals may receive up to 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of support from institutional training grants (e.g., T32) and an individual fellowship award.
Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research and clinical training experiences. See https://researchtraining.nih.gov/resources/policy-notices
NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. See https://researchtraining.nih.gov/resources/policy-notices
The application should request a Kirschstein-NRSA institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. In addition to the standard institutional allowance, the application may request up to $5,000 annually to defray the cost of participation in meetings including annual BRAIN Initiative meetings. See https://researchtraining.nih.gov/resources/policy-notices
NIH does not separately reimburse indirect costs (also known as Facilities & Administrative [F&A] Costs) for fellowships. Costs for administering fellowships are part of Institutional Allowance. See https://researchtraining.nih.gov/resources/policy-notices
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
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
Before submitting a fellowship application, the applicant 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 applicant 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 applicant trained as a graduate student. However, if the applicant 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 must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any 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.
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:
Individuals may not exceed the aggregate limit of NRSA support shown above in the Award Project Period (see Section II. Award Information). Applicant fellows 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.
Buttons to access the online ASSIST system or to download application forms 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.
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:
The letter of intent should be sent to:
Ashlee Van't Veer, PhD
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 followedwith the following additional instructions:
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.
The PHS Fellowship Supplemental Form is comprised of the following sections:
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.
Research Training Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
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.
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)
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 mentor's research, including identifying the components of the research plan that the candidate may take.
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.
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 NIH-defined human subjects research, clinical research, and/or 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. If gaining research experience in a clinical trial led by a sponsor/co-sponsor, provide the sponsor's ClinicalTrials.gov identifier (i.e., NCT number).
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:
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-15-025). 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 complete Section 4 – Protocol Synopsis information or Section 5 – Other Clinical Trial-related Attachments.
Delayed Onset Study
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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 NIMHpeerreview@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
NIH encourages 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. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the applicant'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.
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.
For research that involves human subjects but does
not involve one of the six 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 six 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 the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children 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.
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.
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, 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.
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.
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 applicant, including any prior instruction or participation in RCR as appropriate for the applicant'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.
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.
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 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.
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:
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:
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
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.
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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general 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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. 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. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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.
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 applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, 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)
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Ashlee Van't Veer, PhD
National Institute of Mental Health (NIMH)
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Rebecca Claycamp, MS, CRA
National Institute of Mental Health (NIMH)
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.
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