It is critical that applicants follow the Career Development (K) 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.

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 Research Career Development 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. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of this NINDS Postdoctoral Mentored Career Development Award (K01) is to provide support for the development of a potentially impactful research project, combined with a sustained period (up to 4 years) of intensive research career development under the guidance of an experienced mentor. The project, together with the skills and knowledge obtained, should form the basis for the candidate's projected independent research program. Candidates are eligible to apply for this postdoctoral K01 support in years two through four of cumulative postdoctoral research experience, and may be supported by the NINDS postdoctoral K01 within the first 6 years of cumulative postdoctoral research experience (this eligibility window applies to new and resubmission applications). Although guided by one or more postdoctoral mentors, the candidate will be primarily responsible for the oversight and conduct of the proposed research project. By the end of the K01 award period, the candidate should be poised to begin an independent research career, and have a well-developed, potentially impactful project that can be continued by the K01 awardee in an independent research position.

NINDS has several mechanisms to support mentored, postdoctoral research. This NINDS K01 is intended to facilitate the development of impactful, innovative projects and career development activities that will prepare outstanding, mentored postdoctoral investigators for an independent research career. Successful applicants for this award are intended to be those who have previous high quality research accomplishments, innovative and/or creative ideas, and a potentially impactful project for which they have already obtained some high-quality preliminary data. The candidate's research mentor(s) should have an outstanding record of research accomplishment, including a history of attention to the highest principles of experimental design and data analysis and interpretation. In addition, it is anticipated that the primary mentor will have a record of successfully mentoring others towards their goal as independent researchers. It is acceptable for research to be conducted under the guidance of a primary mentor who has outstanding research credentials but limited track record in training others. In this case, however, there must be one or more additional mentors who are integral to the research career development program and who have a strong training record (including a strong record of trainees who transition to independent research positions). The research project being developed should hold promise to produce highly significant results and future discoveries that will advance the goals of the NINDS mission. The candidate should show promise, via his/her prior accomplishments, as well the plans, ideas and presentation in this application, to be a leader in his/her field.

Projects are encouraged at all levels of investigation, including basic science, that are targeted to understanding central and/or peripheral nervous system processes but may not have direct disease-relevance, basic science with direct relevance to one or more neurological diseases or disorders, or clinical (patient-oriented) research. The integrated program of research and career development is expected to provide applicants with the breadth and depth of understanding that will place them at the forefront of their scientific field.

The production of highly impactful research and pursuit of a competitive, successful research career will require that candidates have a strong working knowledge of their experimental system as well as strong written and oral communication skills. Thus, in addition to high quality, published data and expertise in a research area, the research and career development plan should promote:

• A strong foundation in quantitative reasoning, research design, methods, statistics and analytic techniques appropriate to the proposed research;
• An understanding of, and adherence to, the principles of strict scientific method that ensures robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results;
• An expert understanding of the tools and methods used;
• A breadth of understanding that will enable the candidate, by the end of the postdoctoral training period, to stay current with the rapid expansion of new ideas, approaches and technologies in the candidate's research area;
• Opportunities to present research findings and interact with members of the scientific community at national meetings, as the work progresses;
• The opportunity to publish the research findings as first author; and
• Professional skills and the scientific credentials needed to transition to the next stage of the applicant's research career

The completion of a strong, well-planned, thorough career development plan, in addition to development of an impactful research project, is a critical aspect of this K01. Consequently, applications are strongly encouraged from candidates who are at the earlier end of the eligibility window, to ensure sufficient time to accomplish the career development goals of this FOA.

Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent small clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing an independent small clinical trial as lead investigator, should apply to the companion FOA (PAR-20-050). Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

See Section VIII. Other Information for award authorities and regulations.

NIH grant 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

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are 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.

Any candidate 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 mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups and 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.

This FOA is only open to candidates with a research doctorate (Ph.D. or equivalent) or candidates who have a clinical doctorate but will not have a license to practice clinically for the duration of the K01 award. Individuals who currently have a license to practice clinically, or will have a license to practice clinically at any time during the K01 period, are not eligible. Candidates with a clinical doctorate (M.D. or equivalent) who are or will be licensed to practice clinically are encouraged to use either the K08, K23 or K99 mechanisms. This NINDS K01 will support only those in mentored, postdoctoral research positions. Individuals with any kind of faculty position (including Instructor, Research Assistant Professor, etc.) are not eligible to apply for this NINDS postdoctoral K01. If a K01 awardee transitions to a faculty position within the first 18 months of this award, the award will be terminated. However, if the awardee transitions to a faculty position after the first 18 months of the award, up to 12 months of the remaining time on the award may be used to support the scholar in the independent position.

In addition to standard, automatic NIH leave policies, fellows who have children while supported by an award made under this FOA, either through childbirth or adoption, are encouraged to consider requesting a six-month paid extension of their K01. NINDS may provide one six-month extension during the mentored postdoctoral period to ensure that K01 research and career development can be completed. Requests must be submitted in writing, following the procedures described in the NIH Grants Policy Statement, Section 12.13.1.

Current and former PDs/PIs on NIH research project (R01), program project (P01), center grants (P50), SBIR/STTR (R41, R42, R43, R44), other major individual career development awards (e.g., K01, K07, K08, K22, K23, K25, K76, K99/R00), as well as current and former leads of sub-projects of program project (P01), sub-projects of center grants (P50), or the equivalent of any of these mechanisms, are not eligible. Current and former PDs/PIs of an NIH Small Grant (R03), Exploratory/Developmental Grant (R21), Dissertation Award (R36) remain eligible.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, 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).

Candidates may not submit research project grant (RPG) applications concurrently with the K application, nor can they have a K application and R01 or equivalent application pending simultaneously. K award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD 18-157.

At the time of award, the candidate must have a full-time appointment at the applicant institution. Candidates are required to commit a minimum of nine person months of effort (i.e., 75% of full-time professional effort) to their program of career development during the mentored phase. Candidates may engage in other duties as part of the professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate's research. The mentor must explicitly document the availability of sufficient research support that can be used as needed for the proposed K01 project and facilities for the highest quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team (or advisory committee), if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate's research. The candidate should work with the mentor(s) in preparing the application. The mentor, or an integral member of the mentoring team, should have a successful track record of mentoring individuals at the candidate's career stage, including a record of prior mentees progressing to independent research positions. In addition, all mentors should have a record of conducting research of the highest quality with respect to experimental design and data analysis and interpretation. The mentor(s) should be committed to developing the K01 applicant towards an eventual goal as a competitive candidate for an independent research position.

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in neuroscience research. Applications must include evidence of appropriate institutional commitment to the development of the K01 applicant as a competitive candidate for an independent research position. This commitment does not require the promise of a future faculty position, but includes access to all the space and facilities required to conduct the proposed research, as well as access to resources (both financial and otherwise) required for the highest quality approach to the proposed research and the development of expertise required for future success as an independent scientist.

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 Career Development (K) 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.

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

The following section supplements the instructions found in the SF 424 (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.

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.

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

1. Candidate

2. Research Plan

3. Other Candidate Information

4. Mentor, Co-Mentor, Consultant, Collaborators

5. Environment & Institutional Commitment to the Candidate

6. Other Research Plan Sections

7. Appendix

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

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

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate's goals and commitment to a research career.
• Describe prior training and how it relates to the objectives and long-term career plans of the candidate. This description should include a discussion of how the prior training and research, together with this proposed training and research, will position the candidate to successfully pursue an impactful research project subsequent to completion of the K01 period of support.
• Describe the candidate's research efforts to this point in his/her research career, including any publications, prior research interests and experience.
• Provide evidence of the candidate's potential to develop into an independent investigator. Usually this is evident from publications, prior research interests and experience, and reference letters.

Career Goals and Objectives

• Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator.

Candidate’s Plan for Career Development/Training Activities During Award Period

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. A career development timeline is often helpful. The mentor and any co-mentor may form a mentoring team (or an advisory committee) to assist with the development of a program of study and/or to monitor the candidate's progress through the career development program. It can be best to propose a "gap-based" plan, in which both the applicant and mentor describe the candidate's current expertise and deficiencies, and the plan to eliminate deficiencies. The career development and research aspects of the plan should be thoughtfully integrated, and designed to develop the necessary knowledge and research skills in scientific areas relevant to the candidate's career goals, and to prepare the candidate to develop into a leader in his/her field. Training plans should be specific to the candidate and the candidate's goals; it is advantageous to provide detailed, not vague, descriptions of activities.
• Describe plans to provide opportunities for the candidate to network with other scientists and present research findings at national meetings, and to publish as first author as the research progresses.
• Describe the plans for formal and/or informal training in experimental design and statistical methodology in the context of prior training, as well as design and analytical skills needed for the proposed research project and the anticipated future needs for the candidate. Candidates are expected to leave the K01 career development period with an extremely strong understanding of experimental design and the principles underlying statistics and relevant analyses. The application should carefully describe how this will be achieved.
• Describe the activities designed to enhance the candidate's professional skills (e.g. oral, written, leadership, etc.) needed for a successful research career.
• Describe how the candidate will, by the end of the postdoctoral training, have a broad understanding of the field of neuroscience that will prepare him/her to stay current with the rapid expansion of new ideas, approaches and technologies in the candidate's research area.

Research Plan Section

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

Research Strategy

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided. The research description should demonstrate the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research. The application should clearly distinguish the research of the candidate from the research of others in the environment (using the first person singular narrative when appropriate, and attribution to others when appropriate is strongly encouraged. Writing the entire application in the first person plural narrative will likely prevent reviewer understanding of the candidate's own ideas, research activities and skills acquisition).
• High quality preliminary data should be provided in support of the research plan and the research approach. The candidate should describe the experimental approach as it relates to the best available methods for data collection for achievement of the experimental goals.
• The research project should demonstrate an understanding of rigorous, thoughtful, unbiased experimental design, explicit determination of appropriate sample size, and plans for expert use of appropriate statistical and quantitative techniques for data analysis. The plan should also provide a thoughtful discussion of planned analyses, interpretation and alternative possible results and approaches.
• The application must also describe the relationship between the mentor's research and the candidate's proposed research plan. Although this is a mentored career development award, it is expected that the research project will be primarily overseen and conducted by the candidate, and is intended to form the basis for the candidate's future independent research program (i.e. the candidate should own a project to take out of the mentor's laboratory, with which the mentor will not compete).
• If the applicant is proposing to gain experience in a clinical trial led by a mentor or co-mentor as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

Plans and Statements of Mentor and Co-mentor(s)

• The candidate must name a primary mentor who, together with the candidate, is responsible for planning, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.
• One or more mentors integral to the research and career development of the candidate must have a track record of success in training and progression of trainees into independent research positions.
• The mentor is expected to conduct research with the highest standards of experimental design and analysis, and provide a mentoring plan to ensure development of this expertise and adherence to these principles by the candidate.
• The mentor should provide an explicit description of sufficient independent research support and commitment to cover the costs of the proposed research project in excess of the provided funding of this award.
• Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.
• Include a statement of candidate percent effort committed to the research and career development program. The candidate must commit at least 9 person-months (75% of full-time professional effort) to the research and career development program and related career development activities. If committed effort is less than 100%, describe the non-research commitments and the time required for those commitments.
• The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a description of the mentor's perception of the needs and deficiencies of the candidate, and the mentor's general and specific approaches to filling in the gaps of the candidate's expertise and skills; 4) a plan for career progression for the candidate to move from the mentored career stage to independent research investigator status; and 5) a plan for monitoring and facilitating the candidate's research, publications, and progression towards independence.
• Similar information must be provided by any co-mentor. If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
• The primary mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
• The mentor(s) must describe what part of the proposed project belongs to the K01 candidate, and state that the candidate will have overall responsibility for, and ownership of, this portion of the project and be able to take this portion of the project to an independent research position, use it to pursue additional grant funding and that the mentor will not compete with the candidate on the project that is "owned" by the candidate.
• If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, the mentor or a member of the mentoring team must include a statement to document leadership of the clinical trial, and appropriate expertise to guide the applicant in any proposed clinical trials research experience.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Information, such as that found in biosketches, which clearly documents the appropriate expertise in the proposed areas of consulting/collaboration, should be provided. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. These individuals should provide their biographical sketches.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development environment related to the candidate's area of interest. This should include high-quality resources, space and key faculty members and other investigators capable of productive collaboration with the candidate.
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.

Institutional Commitment to the Candidate’s Research Career Development

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award.
• Provide assurances that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) and up to 12 person-months (100% of full time professional effort) to the development of their research program. Any effort not related to the K01 research and career development should be devoted to activities related to the development of the candidate's career as an independent scientist.
• The institution must document that the candidate will have appropriate office and laboratory space, and access to equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed research plan.
• Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

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.

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:

• For FOAs that do not allow independent clinical trials, 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.

Candidates 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 Referee Information link and not through Grants.gov.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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

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: Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

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.

Candidate

• Does the candidate have the potential to develop as an independent and productive researcher?
• Are the candidate's prior training and research experience appropriate for this award?
• Is the candidate’s academic, clinical (if relevant), and research record of high quality?
• Is there evidence of the candidate’s commitment to meeting the program objectives to become an independent investigator in research?
• Do the reference letters address the above review criteria, and do they provide evidence that the candidate has a high potential for becoming an independent investigator?
• Based on prior publications, accomplishments and the quality of the proposed research and career development activities, does the candidate have the potential to develop into an independent and productive researcher, and show promise to be a leader in his/her field?
• Does the candidate's prior work demonstrate a dedication to the principles of rigorous experimental design, statistical treatment and unbiased analysis?

Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring

• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
• Are the candidate's prior training and research experience appropriate for this award?
• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
• Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
• Based on the candidate's prior experience and career development plan, will the candidate become expert in experimental design, relevant statistical needs and methodology, relevant data analysis and quantitative reasoning?
• Does the career development plan provide adequate opportunities to present research findings and meet with scientists in the community at national meetings as the work progresses?
• Does the career development plan explicitly describe the opportunity for the applicant to publish the research findings as first author?
• Will the career development plan provide the professional skills needed for the applicant to transition to the next stage of his/her research career?
• Is the career development plan, combined with the proposed research project, expected to develop the candidate into a leader in his/her field?
• Is the proposed duration of this award sufficient to complete a strong, thorough career development plan, in addition to developing an impactful research project?
• Is there confidence that, by the end of the postdoctoral training period, the candidate will have a broad understanding of the field of neuroscience that will prepare him/her to stay current with the rapid expansion of new ideas, approaches and technologies relevant to the candidate’s research area?
• If proposed, will the clinical trial experience contribute to the applicant’s research career development?

Research Plan

• Is the prior research that serves as the key support for the proposed project rigorous?
• Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
• Will the research plan ensure an understanding and application of the principles of strict scientific methods that ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Are the proposed research question, design, and methodology of significant scientific and technical merit?
• Is the research plan appropriate for the candidate based on the candidate's prior record and proposed career development plan, and objectives?
• Will the research plan provide a strong foundation in quantitative reasoning and analytic techniques appropriate to the proposed research?
• Are the tools and methods used appropriate for the proposed research? Will the research plan provide the applicant with an expert understanding of the tools and methods used?
• Is the applicant's proposed research sufficiently distinct from the sponsor's ongoing research to suggest that the applicant contributed to the development and design of the project, and has primary responsiblity for the oversight and conduct of the research? Is the distinction between the candidate's research and that of others in the environment clear from the application?
• Is the proposed research project well-developed, and likely to be impactful with the potential for highly significant results and future discoveries, and to form the basis of the candidate's future independent research program?
• If proposed, will the clinical trial experience contribute to the research project and/or the applicant's research career development?
• If proposed, will the clinical trial experience contribute to the proposed research project?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

• Are the qualifications of the mentor(s) in the area of the proposed research outstanding?
• Does the mentor, or an integrally involved co-mentor, have a strong record in developing postdoctoral researchers into independent researchers?
• Does the mentor(s) adequately address the candidate's potential and his/her strengths and areas needing improvement?
• Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
• Is the mentor’s description of the elements of the research career development activities, including formal course work adequate?
• Is there evidence of the mentor s, consultant s, and/or collaborator’s previous experience in fostering the development of independent investigators?
• Is there evidence of the mentor's current research productivity and peer-reviewed support?
• Is the mentor currently productive in research and does he/she have appropriate support? Does the mentor publish research findings of the highest quality with regard to technical and methodological implementation and unbiased, well-controlled experimental design?
• Is active/pending support explicitly committed by the mentor as available to the proposed research project and adequate?
• Are there adequate plans to monitor and evaluate the career development of the awardee's progress toward independence?
• Does the mentor explicitly describe the portion of the candidate's project that belongs to the candidate and which the candidate can take to launch an independent research program without competition from the mentor?
• Do the named collaborators/consultants have the appropriate expertise for their proposed contributions? Is there evidence that the collaborators/consultants are committed to the project, and that their involvement will add value to the candidate's research and career development plan?
• If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?

Environment & Institutional Commitment to the Candidate

• Is there clear commitment of the sponsoring institution to ensure that a minimum of 9 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research and career development activities described in the application, with the remaining percent effort being devoted to an appropriate balance of research, teaching, administrative, and clinical responsibilities? If less than 100% of the candidate's effort is devoted to the proposed career development and research plan, are the activities that consume the remaining percent effort directly appropriate for the candidate's career goals?
• Is the institutional commitment to the career development of the candidate appropriately strong?
• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
• Is the environment for the candidate’s scientific and professional development of high quality?

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.

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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

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

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals across the lifespan (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.

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.

Not Applicable

Not Applicable

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 mentor(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 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 (GDS).

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.

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 the NINDS Scientific Review Branch 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 selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

1. Scientific and technical merit of the proposed project as determined by scientific peer review.

2. Availability of funds.

3. 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 all 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. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. 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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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 accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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, 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)

GrantsInfo (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-637-3015

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

Stephen Korn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Email: korns@ninds.nih.gov

Ernest Lyons, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: lyonse@ninds.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

Department of Health
and Human Services (HHS)