Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Other Award Budget 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall purpose 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 Research Training and Career Development website.

The goal of the Career Transition Award (K22) is to provide support to newly trained basic or clinical investigators to develop their research skills through a two phase program: an initial period involving an intramural position at the NIH and a subsequent period of support at an extramural institution. The award is intended to facilitate the establishment of a record of independent research by the candidate in order to sustain or promote a productive, independent research career.

The goal of this NINDS K22 program is to foster the integration of highly skilled, NIH-trained neurologists and neurosurgeons into the pool of clinicians-scientists conducting neuroscience research at institutions across the country. This funding opportunity is available to licensed neurologists and neurosurgeons in the NINDS intramural program who are within 4 years of completion of residency or clinical fellowship. For this 5-year award, recipients may spend up to 2 years in the intramural phase, with the balance (3 years or more) in the extramural phase. The entire award is intended to be mentored, but a transition to independence is strongly encouraged during the extramural phase of the award (see: Transition to the Extramural Phase in Section VI of this NOFO). In order to transition to the extramural phase, recipients must obtain a faculty position at an academic institution that will provide a minimum of 9 person-months (75% of full-time professional effort) to neurologists or 6 person-months (50% full time professional effort) for neurosurgeons that is entirely dedicated to research. In addition, the extramural institution must provide access to the resources, and have appropriate mentor(s), needed for completion of the K22 award research project and development of a strong application for an NIH R01 or equivalent award. This extramural position should either be a tenure-track position or an equivalent, secure faculty position, which includes a strong institutional commitment that will facilitate progress towards a successful dual career as clinician and research scientist. In order to obtain the 5th year of K22 funding, recipients must work with their institutions to submit an NIH R01, DP1 or R21 application, as PD/PI, by the end of the 4th year of the K22 award.

This NOFO is intended to facilitate the transition of NINDS intramural clinician-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities. As such, candidates should develop, with their mentors, a comprehensive, coherent career development plan to gain the knowledge and skills required to succeed in such positions. Components of the plan should include, grant-writing and oral presentation, specialized coursework if needed, and strong expertise in experimental design and statistical methodology. Regardless of their research question or approach, candidates should obtain a fundamental understanding of the requirements for experimental rigor (see, for example, NOT-NS-11-023 and the related NINDS Transparency in Reporting guidance) and build such rigorous processes into their research project. Proposed career development experiences might include networking with key researchers in their field, both nationally and internationally, attendance at workshops designed to enhance specialized knowledge and skills, and presentations at national and international meetings. Candidates should also receive guidance on administrative skills associated with an independent research career at an extramural institution, which may include, managing a laboratory, managing a budget, managing personnel, recruitment of human subjects, organizing multiple sites for clinical research activities, etc.

In concert with the career development plan, candidates should also propose a well-conceived research plan that investigates a highly significant, scientific problem within the NINDS mission. The proposed initial phase of the research to be conducted at the NIH intramural program should be designed to continue at an extramural academic institution during the second phase of the research. Projects that require special resources available only at the NIH intramural program are acceptable if 1) collaborative efforts with NIH staff can be maintained, 2) it is clearly feasible to continue timely research activity that requires these resources, and 3) collaborators and the NINDS scientific director commit to the continued collaboration. Regardless of whether special NIH resources are necessary to continue the project in the extramural phase, a significant component of the proposed project must belong to the candidate, such that they are free to pursue the project at an extramural institution without competition from the mentor(s) at NIH.

As this is a mentored, career-development award, candidates should have one or more mentors who will fulfill all of the candidate's career development needs. Mentors are expected to contribute to the successful completion of all career development plan components, as well as provide guidance on choosing, and negotiating for, an appropriate extramural position.

Note: This Notice of Funding Opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (PAR-25-215).

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Other Award Budget Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Only NINDS may apply for the initial mentored phase of the K22 mechanism on behalf of intramural neurologists or neurosurgeons. NINDS is not eligible to apply for the extramural phase of the award. Public and private institutions of higher education, as well as For-profit and Non-profit institutions affiliated with a medical school, may serve as institutions for the extramural phase of the award only after an initial award is made to the NINDS intramural applicant. 

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

• 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 SAM registration in order to complete the Grants.gov registration.

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

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

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Candidates must be within 4 years of completion of residency or clinical fellowship for the initial application and within 5 years of completion of residency or clinical fellowship for any amended applications. This NOFO is restricted to individuals who are clinically licensed, neurologists or neurosurgeons in the NINDS intramural program.  Any individual(s) 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 their mentor and organization to develop an application for support (see specific information available for intramural candidates on the Electronic Submission Intranet – link available only to users internal to NIH). Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 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).

Candidates for the K22 award must have a clinical doctorate (including MD, DO, or equivalent clinical doctoral degree), or a clinical and research doctoral degree.

Individuals must be in the career development phase of development; individuals who are independent researchers are not eligible for this award.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definitions of Terms. 

3. Additional Information on Eligibility

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

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Candidates may not submit research project grant (RPG) applications, or have RPG applications pending council review, concurrently with the K application.

Individuals are NOT eligible to apply if they had any individual NIH career development award, or have pending an application for any other PHS career development award or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply if they have been or are currently a PD/PI on an NIH research grant (such as R01, R03, R21, P01) or a Project Lead on a Program Project (P01) or Center Grant (P50), or a non-NIH equivalent to these grants/awards.

At the time of award, the candidate must have a “full-time” appointment at the organization. Neurologists are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) and neurosurgeons are required to commit a minimum of 50% of full-time professional effort (i.e., a minimum of 6 person-months) to their program of career development. Candidates may engage in other duties as part of their remaining full-time 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-18-156  and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

Mentor(s)

Before submitting the application, the candidate must identify a mentor at NINDS 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 document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In particular, candidates are strongly advised to involve a co-mentor at an extramural institution who can guide the applicant with regard to obtaining an extramural position and leading a research group in an extramural institution. The primary mentor should have a successful track record of mentoring individuals at the candidate's career stage. Women, individuals from underrepresented racial and ethnic groups, and individuals with disabilities are encouraged to participate as mentors or co-mentors.

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

Both the intramural and extramural environments must have strong, well-established records of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Project Summary/Abstract

Include a description of your current research and the research you propose to continue in the independent phase.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Career Development Award Supplemental Form

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

Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional Commitment to the Candidate
Other Research Plan Sections
Appendix

All instructions in the How to Apply - Application Guide must be followed.

Candidate Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate’s commitment, as evidenced by prior history and future plans, to a career in a biomedical or behavioral research field relevant to the mission of the NINDS.
• Describe how the prior and current training and research efforts of the candidate relate to this commitment.
• Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and reference letters.
• Describe all of the candidate's professional responsibilities at NINDS and elsewhere and show their relationship to the proposed activities on the career award.
• Describe the candidate's clinical experience and ability to combine a research and clinical career.
• Describe the candidate's plan for transition to an extramural position that combines clinical and research opportunities.

• If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial.
• If applicable, describe the candidate's prior efforts, interests and experience in clinical trials research.

Career Goals and Objectives​

• Describe a systemic plan: (1) that shows 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. This should be framed as a gap-based plan, whereby the candidate describes the strengths and weaknesses in their research, skills and knowledge, and describes a plan to fill in the training gaps required to launch a highly successful research career.
• Describe the candidate's current and long-term research and career objectives.
• The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

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

• A systematic plan should be presented for obtaining the background, research experience, and career development activities necessary to launch an independent research career. Describe current activities and how they relate to the candidate's career development plans and career goals. Describe proposed activities, e.g., those that will lead to new and/or enhanced research skills and knowledge, as well as necessary professional skills such as grant-writing, communication and leadership. The career development plan must be specifically tailored to meet the needs of the candidate and the goal of achieving independence as a researcher. 
• Describe the professional responsibilities/activities, including other research projects that fall outside of the minimum commitment to the K22 award activities of 9 person-months (75% full-time professional effort) for neurologists and 6 person-months (50% full time professional effort) for neurosurgeons. The total time required for these non-K22 activities should be explicitly described, with the time devoted to each explicitly stated. Explain how these responsibilities/activities will help ensure career progression to achieve independence as an investigator.
•  Describe planned didactic components, workshops, meetings, collaborative activities and other relevant research and educational activities that will contribute to the research career development of the candidate. Describe specific activities, in detail, that will provide a solid understanding of the fundamentals of experimental design, statistical methodology, data analysis and scientific rigor. This description must include formal activities, engaged in previously or planned, that will provide the candidate with strong expertise in experimental design and the breadth of statistical methodologies relevant for different types of biomedical research. 
• Describe the specific activities designed to obtain a practical knowledge of the administrative skills associated with an independent research career in an extramural environment, which may include, as applicable, managing a laboratory, managing a budget, managing personnel, recruitment of human subjects, organizing multiple sites for clinical research activities, combining a clinical practice with research career, etc. The mentor, or mentorship team mentors, who will oversee this part of the career development plan should be explicitly named. 
• A timeline is strongly encouraged. This timeline should include expectations for activities that will be completed in the first phase (intramural) and the second phase (extramural) of the award. Of particular importance is a description of the timeline of achieving milestones, such as what experiments will be required for an initial publication, expectations for minor and/or major publications as they relate to the research plan, any anticipated productivity requirements for obtaining an extramural position, etc.
• Applicants are strongly encouraged to form an active advisory committee (or mentoring team) to assist with the development of the program of study and to monitor the candidate's progress during the career development program. Moreover, it is highly recommended that this advisory committee contain at least one extramural investigator who can provide career guidance on transitioning to an extramural position. If such a team is formed, applicants should describe the anticipated makeup of the committee, the planned frequency of meetings and group vs individual expectations for advisory committee members. 
• Describe the specific plan for transition to the extramural phase of the award. This plan should include information on 1) the expected timing of the transition, 2) the type of position that will be sought, 3) what niche the applicant hopes to fill in an extramural position, 4) what special resources would be required at the extramural institution for the successful continuation of the research and what resources, if any, might be unique and require collaboration with NINDS (if no unique resources are needed this should be clearly stated), and 5) other information the applicant deems pertinent.

Research Plan Section

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Strategy

• The research plan must span both phases of the award. The candidate should clearly indicate the research planned for each phase. This narrative should describe what the candidate will accomplish during the mentored phase research that will enable them to launch an independent research program (i.e., what does the candidate still need to accomplish during the mentored phase in order to obtain an extramural faculty position, launch a successful independent research career and submit a competitive NIH grant application).
• The proposed research plan should be described within the context of the scientific literature already in existence related to the project. This description should convey a mastery of the scientific literature relevant to the project, as well as the rigor of the papers that are cited as key evidence in support of the proposed project.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan. If more than one mentor is proposed, the respective areas of expertise and responsibility should be described. Both the candidate and mentor(s) should clearly describe which aspects of the research proposed belong to the candidate, such that once the candidate transitions to an extramural position, the mentor(s) will not continue with, or compete in, this part of the project.
• The application must describe how the mentored phase research will lead to the independent phase research.
• If a patient population is required for the research, details should be provided regarding the pool of patients available, access to the patient population, recruitment strategies, any potential obstacles, any relationship between the clinical and research activities of the candidate that involves these patients, and any special problems that may be encountered because of the population being studied. The candidate should also describe how the project will be continued during the extramural phase of the award if the project requires a specific patient population.
• If patient-oriented research is proposed, the application should clearly describe the expected clinical impact of the research.
• If unusual or special equipment, available during the intramural phase of the application, is required for the proposed research, the application should address the availability, or lack of requirement, for this equipment during the extramural phase of the award. The application should make clear the planned research accomplishments during the first 4 years of the K22 that will support a competitive application for an NIH R01, DP1 or R21 award by the end of the 4th year of the K22 award.
• The application should describe any collaborative arrangements required for the research, and how these collaborative arrangements will be continued after the transition to the extramural phase of the award.

• Describe the proposed timelines for the proposed clinical trial, feasibility study or ancillary clinical trial, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).
• Describe how the proposed clinical trial or ancillary clinical trial will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study).

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 How to Apply - Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

All instructions in the How to Apply - 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 the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
• The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
• The primary mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. 
• The primary mentor's statement should provide, in narrative form: 1) information on their research qualifications and previous experience as a research supervisor; 2) a plan describing the nature of the supervision and mentoring that will occur during the proposed K22 award period, including how the candidate's scientific and professional progress to independence will be promoted; 3) a description of the training needs of the candidate (candidates who are already independent are not appropriate for this award); 4) a description of the elements of the planned research skills development and career development, including any formal course-work; 5) a plan for transitioning the candidate from the intramural phase to the extramural phase of the award and a description of how the mentor will help the candidate progress towards scientific independence from their mentor(s); and 6) when appropriate, a statement affirming any resources and reagents that can be taken by the candidate to the extramural phase of the award. In addition, the mentor must specifically identify what elements of the proposed research project the K22 candidate can take when they transition to the extramural phase and provide assurance that they will not directly compete with the candidate with regard to these specific elements. If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should be included.
• If more than one mentor is proposed, the specific contributions of each mentor and co-mentor to the research and career development plan should be described by the applicant. In addition, all mentors should describe their expertise and their understanding of their roles in the candidate's research and career development. A plan should be provided that clearly describes how mentors will coordinate the mentoring of the candidate. If any of the co-mentors are not located at the sponsoring institution (i.e. the NIH campus), a statement should be provided by the mentor(s) describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
• The mentor whose role it is to guide the candidate with regard to understanding issues pertaining to obtaining an extramural faculty position and leading a research operation in an extramural institution should describe their qualifications for this role and the mentorship plan regarding these issues.
• The primary mentor must (and ideally, all mentors will) agree to assist the candidate in transitioning to an extramural research position by guiding the candidate during the job search and negotiation process.
• The mentor(s) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.
• The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the candidate in the organization, management and implementation of the proposed clinical trial, ancillary or feasibility study and help them to meet timelines.

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. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. 
• Advisory committee members (if applicable): The research expertise to be sought in the Advisory Committee should be described, but the members should not be named in the application. The names should be submitted as part of the just in time information. Advisory Committee members may be established faculty at either the candidate’s institution or at another institution. Members should be chosen for their expertise in the research project proposed by the candidate.

Environmental and Institutional Commitment to the Candidate

All instructions in the How to Apply - 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 program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. 
• Describe the resources and facilities that will be available to the candidate. 
• Describe the sponsoring institution’s scientific environment including the resources and facilities that will be available to the candidate. 

• Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.
• Describe the specific community that will contribute to the candidate's career development. This community may include faculty, postdocs, students, technicians and any other contributing personnel (do not list the entire intramural staff; discuss only those that are directly relevant to the candidate and candidate's research project and career development plan). If applicable, list activities that foster scientific interaction within the community.

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 have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations, as applicable) 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.
• The sponsoring institution must include a statement that the candidate will commit at least 9 person-months (75% of full-time professional effort) for neurologists, 6 person-months (50% full-time professional effort) for neurosurgeons, to the career development program and related career development activities, and explain explicitly (i.e. with time requirements) how all non-K22 activities combined will require 25% or less (50% or less for neurosurgeons) of the candidate's professional effort. Note that NINDS evaluates time commitment as follows: 1/2 day per week = 10% effort, 1 month per year = 8% effort, periods with on call responsibilities are not considered protected time for research.
• If special resources available only at NIH intramural program are required, the K22 application should clearly state this, describe how collaborative efforts with NIH staff will be maintained, and provide all necessary commitments (from the collaborators(s) and NINDS Scientific Director) attesting to the feasibility, willingness and provision of any financial requirements on the part of the NINDS intramural program, to collaborate. If no special resources are required that would limit award portability to an extramural institution, this should be stated, and if appropriate, explained.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

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.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

Reference Letters

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. 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply - Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

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

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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.

The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through career development awards may be sufficient to support only small feasibility studies.

  Candidate

• Does the candidate have the potential for becoming a successful independent investigator who will contribute significantly to a chosen health-related research field? 
• Will the research experiences in the mentored phase prepare the candidate to implement successfully the independent phase research project?

• Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

• Has the candidate demonstrated that they can perform significant, high quality scientific research? 
• Did the candidate's prior research and training experiences prepare them to pursue the proposed research using state-of-the-art approaches?

Career Development Plan/Career Goals and Objectives

• Are there plans for evaluating the candidate's progress and are they adequate and appropriate for guiding the candidate towards a successful transition to the independent phase of the award?
• Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for the independent phase of the award?
• Is the career development plan “gap-based” and consistent with the candidate's research and career goals?
• What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
• Is the career development plan, combined with the candidate’s prior experience, appropriate for the timeline proposed for transition to the extramural phase, and for the expectation that a competitive NIH R01, DP1 or R21 application will be submitted by the end of the 4th year of the K22 award period?
• Does the career development plan, outside of the proposed research plan, adequately provide knowledge, skills and experiences required for successful independent research in an extramural position (e.g. grant writing, networking, communication skills, leadership, lab management, navigating a dual clinician-researcher career, etc.)?
• Based on the specific details provided, will the candidate obtain strong expertise in principles of experimental design, a solid understanding of the breadth of statistical methodology utilized for biomedical research and sophistication with respect to data analysis?
• Is there a specific set of time commitments that explain the candidate’s time commitment to research and research career development, at least 9 person-months for neurologists (75% of full-time professional effort) or at least 6 person-months for neurosurgeons (50% of full time professional effort)?Are the non-research commitments of the candidate clearly described in terms of the actual time commitment required to fulfill them?

• If proposed, will the clinical trial experience contribute to the applicant’s research career development?

Research Plan

• Has the candidate proposed a research project that addresses a significant question in the field, with a proposed experimental and analytical plan that will clearly address the question(s)?
• 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 of the proposed project?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• Is the proposed research project appropriate for the candidate's stage of research development and as a vehicle for development of the research skills described in the career development plan?
• Will the research plan foster adequate progress towards the candidate’s research career objectives, such that by the completion of the proposed research it can reasonably be expected to lead to a successful NIH grant application?
• Does the candidate demonstrate a mastery of the scientific literature with respect to the proposed project, and are hypotheses, experimental design, and analytical methodology adequately described and appropriately rigorous?
• Will the research project address an innovative hypothesis, challenge existing paradigms or otherwise make a highly significant contribution to the field? Does the project develop or employ novel concepts, approaches, methodologies, tools or technologies? Does the project make use of, or lead to, a unique set of skills of the candidate?
• Does the research plan include an adequate description of expected results, approach to data interpretation, alternative hypotheses, potential problems and solutions to those problems?
• If human subjects are involved, does the research plan adequately address issues related to recruitment, potential obstacles related to the particular population, and transportability of the research to the extramural phase of the award?
• If the research plan requires special, NIH-specific resources (e.g. equipment, expertise, patient population, etc.), is there adequate evidence that the research plan can be continued during the extramural phase?
• Is the proposed research designed to lead to a highly successful independent line of research for the candidate? If the proposed research discipline requires team-based approaches, will the candidate develop skills to play a major leadership role in the chosen research field?
• Is the research project adequately distinct from the mentor's research to allow transition of the project to the exclusive control of the candidate?

• Are the scientific rationale and need for a clinical trial, ancillary clinical trial, or feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
• If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
• Is the clinical trial or ancillary clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?
• Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
• Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
• Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions, if interventions are delivered?
• For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

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

• Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
• Does the mentor(s) adequately address the candidate’s potential and their strengths and areas needing improvement?
• Is there adequate description of the quality and extent of the primary 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?
• Based on the mentor’s statement, are adequate funds committed to the proposed research during the intramural phase?
• Are there adequate plans for monitoring and evaluating the career development recipient's progress toward independence?
• Do the candidate and mentor provide an adequate description of the quality and extent of the mentor's proposed role in providing guidance and advice to the candidate for the proposed research and career development?
• If applicable, do co-mentors describe their role in the research and career development plan, as well as the frequency and expected plans for meeting with the candidate?
• Are the research career development activities, and mentoring plan, tailored to, and adequate to achieve the candidate's needs?
• Does the mentoring team have appropriate research and training experience to successfully guide the candidate in their research, career development and transition to independence?
• Is there a mentor with the appropriate qualifications to guide the candidate in skills and knowledge required to obtain an extramural position, lead a research program in an extramural environment and obtain research funding, and is there a plan to provide adequate guidance?
• Does the mentor describe their expectation for the transition of the candidate to the extramural phase of the award, including the projected timing of this transition, and the guidance they will provide to facilitate this transition?
• Does the mentor clearly and explicitly describe the elements of the project the candidate can take with them to the extramural phase of the award and the resources, if any, the candidate can take to the extramural phase of the award? Does the mentor clearly state that they will not compete with the candidate in pursuit of this portion of the project? Is this portion of the project completely owned by the candidate suitable to launch a highly successful independent career?
• If applicable, does the mentor adequately address the ability of the candidate to access any special NIH resources that are needed during the extramural phase of the award? If applicable, does the mentor adequately address their willingness to continue collaborating with the candidate, and the expectation for this collaboration?

Consultant(s), Collaborator(s)

• Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
• Have the proposed consultant(s) and collaborator(s) provided evidence of commitment to the candidate and the candidate’s project?
• Do the proposed consultant(s)/collaborator(s) provide the required expertise for successful conduct of the research project?

• Does the mentor or mentoring team have the expertise, experience, and ability to guide the candidate in the organization, management and implementation of the proposed clinical trial, ancillary clinical trial, or feasibility study and help them to meet timelines?

Environment & Institutional Commitment to the Candidate

• Are the research facilities, resources and training opportunities, including faculty capable of productive collaboration with the candidate adequate and appropriate?
• Is there clear commitment of the sponsoring institution to ensure that the required effort of the candidate will be devoted directly to the research career development, and research activities described in the proposed career development and research plans?
• Is there strong institutional commitment to fostering the career development of the candidate?
• Are there unique features of the scientific environment that benefit the proposed research; e.g., useful collaborative arrangements or subject populations?
• Is the environment of high quality and relevance for scientific and professional development of the candidate?
• Is the environment suitable for the candidate's success in the proposed scientific and career development goals of the candidate?
• Does the environment include an oversight mechanism to ensure the successful progress of the candidate towards their research and career development goals?
• Does the letter of commitment from an appropriate individual clearly state what the candidate's non-research commitments during the intramural phase will be, and describe the calculation (i.e. time committed to non-research responsibilities) to demonstrate that they will consume 3 person-months (25% of full-time professional effort) or less for neurologists, 6 person-months (50% of full time professional effort) or less for neurosurgeons?

• Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
• Does the application adequately address the capability and ability to conduct the trial, ancillary clinical trial, or feasibility study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
• If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

Study Timeline for Clinical Trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

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

Revisions

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.

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Training in the Responsible Conduct of Research

All applications for support under this NOFO must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the 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.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter that will include the terms and conditions of the NIH intramural K22 award, as well as expectations for the transition to the independent phase of the award.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

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

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Transition to the Independent Phase

Transition from the intramural phase to the extramural phase is not automatic, and requires administrative approval by NINDS extramural program staff. Approval of the transition will be based on several factors. The recipient's progress during the intramural phase will be determined from a progress report included in the request to transfer the award (see below). The recipient's research and career development plans for the extramural phase, included in the request to transfer the award, will be evaluated in light of the progress already made. The sponsoring institution must provide either a tenure-track or equivalent position, or a faculty position with a strong institutional commitment to facilitate progress towards a successful dual career as a clinician and research scientist in a secure faculty position. The sponsoring institution must provide a minimum protected time for research of nine person-months (75% full time professional effort) for neurologists, six person-months (50% full time professional effort) for neurosurgeons (as in the initial application, the extramural institution must provide a detailed explanation of the non-research responsibilities, and the time required for them, that leads to the calculation of protected time). The institution must also provide the space and resources needed to conduct the proposed research project, as well as a description of startup funds provided. Careful attention should be paid to appropriate mentoring at the extramural institution. The extramural institution should have an appropriate scientific mentor for the project, and the candidate should include any additional mentors required for comprehensive guidance in the candidate's career path. It is essential that the request to transition include a plan for career development that will lead to research independence, the ability to successfully compete for research support, and a commitment from the extramural mentor and institution to support the candidate's progress towards a successful research program and independent funding. NINDS must have appropriate documentation no later than two months before the end of the intramural phase (e.g. no later than two months before the end of the 2nd year of the K22 award) in order to avoid a potential interruption in funding. Except in rare, extenuating circumstances, if the recipient does not secure an extramural position by the end of the 2nd year of the K22 award, the K22 award will be terminated.

 The application for the extramural phase of the award must be submitted no later than 2 months prior to the proposed activation date of the award by extramural recipient organization. However, to avoid potential problems in activation, applicants are strongly encouraged to contact the Director, Office of Training and Workforce Development, NINDS as soon as plans to assume an extramural position develop, and not later than 6 months prior to the end of the intramural phase of the award, to discuss plans for transition to, and the application for, the extramural phase. An eligible extramural institution for this K22 must have the appropriate infrastructure to support the proposed research program and a history of external research funding.

Candidates must provide a progress report using form PHS 2590, which should detail progress achieved on the specific aims of the Research Plan and on the pursuit of identified career and career development goals. Future goals for the research project and for further career development should also be indicated. The mentor must provide a separate narrative of the research and career development of the candidate.

Form PHS 2590 must include the following:

• A description of the proposed research.
• A description of the institutional environment, including: research facilities and the availability of appropriate educational opportunities, including collaborating faculty, when necessary; quality and relevance of the environment for scientific and professional development of the candidate.
• Information about the sponsoring institution’s commitment to the candidate and to the candidate’s scientific independence, including: commitment to ensuring that the candidate’s effort required by the K22 program will be devoted directly to the research and career development activities described in the proposed career development and research plans; institutional commitment to fostering the career development of the candidate.
• Position Description: the institution should provide a detailed description of the candidate’s position, responsibilities, and duties. The institution’s tenure-track policy should be defined or a description should be provided of the equivalent arrangements for institutions without a formal tenure-track.
• Budget in detail, including justification for all requested funds:
• List the name, role on project and percent effort for all project personnel (salaried and unsalaried) and provide a narrative justification for each person;
• Identify all consultants by name and organization affiliation and describe the services to be performed;
• Provide a narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project;
• Describe specific resources committed by the sponsoring institution to support the Candidate’s research.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

5. Evaluation

In carrying out its stewardship of human resource-related programs, 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.

Section VII. Agency Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

Letitia Weigand, Ph.D.
National Institutes of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Chief, Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

Section VIII. Other Information

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.

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