Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title
Career Transition Award for NINDS Intramural Clinician-Scientists (K22 Clinical Trial Not Allowed)
Activity Code
K22 Career Transition Award
Announcement Type
Reissue of PAR-18-711
Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-21-328
Companion Funding Opportunity
PAR-21-327 , K22 Career Transition Award
Assistance Listing Number(s)
93.853
Funding Opportunity Purpose

This NINDS K22 is specifically designed to facilitate the transition of NINDS intramural neurologist- and neurosurgeon-scientists to independent, academic faculty positions that support clinician-scientists to engage in independently funded scientific research as well as clinical activities.

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a 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 a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA PAR-21-327.

Key Dates

Posted Date
September 10, 2021
Open Date (Earliest Submission Date)
September 12, 2021
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 12, 2021 * November 12, 2021 * Not Applicable March 2022 May 2022 July 2022
February 12, 2022 * March 12, 2022 * Not Applicable July 2022 October 2022 December 2022
June 12, 2022 * July 12, 2022 * Not Applicable November 2022 January 2023 April 2023
October 12, 2022 * November 12, 2022 * Not Applicable March 2023 May 2023 July 2023
February 12, 2023 * March 12, 2023 * Not Applicable July 2023 October 2023 December 2023
June 12, 2023 * July 12, 2023 * Not Applicable November 2023 January 2024 April 2024
October 12, 2023 * November 12, 2023 * Not Applicable March 2024 May 2024 July 2024
February 12, 2024 * March 12, 2024 * Not Applicable July 2024 October 2024 December 2024
June 12, 2024 * July 12, 2024 * Not Applicable November 2024 January 2025 April 2025

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
July 13, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions
It is critical that applicants follow the instructions in 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.

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.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 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, awardees 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 FOA). In order to transition to the extramural phase, awardees 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, 6 person-months (50% full time professional effort) for neurosurgeons that is entirely dedicated to research. In addition, the institution must provide access to the resources, and have appropriate mentor(s), needed for completion of the K award research project and development of a strong application for an NIH R01 or equivalent. This 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, awardees must submit an NIH R01, DP1 or R21 application, as PD/PI, by the end of the 4th year of the K22 award.

This FOA 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, awardees should develop, with their mentors, a comprehensive, coherent career development program to achieve the knowledge and skills required to succeed in such a position. Applicants should have 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. In addition, regardless of whether special NIH resources are necessary for conduct of the project in phase II, a significant component of the proposed project must belong to the applicant, such that he/she can pursue the project in phase II without competition from the mentor(s) at NIH.

In addition to the specific research plan, applicants should develop a plan to obtain the skills and experiences that facilitate a successful, independent research career. Skills should include grant-writing and oral presentation skills, specialized coursework if needed, and strong expertise in experimental design and statistical methodology. Regardless of the research question or approach, applicants 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. 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. Applicants should also receive guidance on administrative skills associated with an independent research career in an extramural institution, which may include, as applicable, managing a laboratory, managing a budget, managing personnel, recruitment of human subjects, organizing multiple sites for clinical research activities, etc.

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

Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary 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 a clinical trial or an ancillary study to an ongoing clinical trial as lead investigator, should apply to the companion FOA PA-21-327. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.

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

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget
Award budgets are composed of salary and other program-related expenses, as described below.
Award Project Period
The total project period may not exceed 5 years.

Other Award Budget Information

Salary

During the intramural support years, salary will be consistent with that provided by the intramural programs for other investigators in the same position. During the extramural support years, NINDS will contribute up to $100,000 per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094

The total NIH contribution to salary may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm

Other Program-Related Expenses

During the intramural support years, the NINDS intramural program will contribute $25,000 per year towards the research career development costs of the award recipient. During the extramural support years, NINDS will contribute $50,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs
Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)
  • Eligible Agencies of the Federal Government

Federal Governments

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

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 phase II 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 phase II of the award.

Foreign Institutions
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 not allowed. 
Required Registrations

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) (formerly CCR) – 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.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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 FOA is restricted to individuals who are clinically licensed, neurologists or neurosurgeons in the NINDS intramural program, 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 (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. 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 FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

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 per 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 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.

Level of Effort

To obtain phase II of the award, K22 awardees must have a “full-time” appointment at the academic institution. Neurologists are required to commit a minimum of 9 person-months (75% of full-time professional effort) to their career development (K22) project. Neurosurgeons must devote a minimum of 6 person-months (50% of full-time professional effort) to their K22 career development project. Candidates may engage in other duties as part of the remaining 25% (for neurologists) or 50% (for neurosurgeons) of their 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. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors or co-mentors to serve as role models and potentially provide different perspectives.

Institutional Environment

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 FOA. 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 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.

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 SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

R&R Budget

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

PHS 398 Cover Page Supplement

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

Candidate Section

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 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.

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. This should be framed as a gap-based plan, whereby the candidate describes the strengths and weaknesses in his/her research, skill 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.

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 SF424 (R&R) 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 him/her 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 applicant that involves these patients, and any special problems that may be encountered because of the population being studied. The applicant 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, applicants 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.
  • If proposing an ancillary study to an ongoing clinical trial, provide a brief description of its relationship to the larger clinical trial.
  • If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials.

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 the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
  • The mentors should be recognized as accomplished investigators in the proposed research area or other relevant activity, and at least one mentor, preferably the primary mentor, must have a track record of success in training clinicians in postdoctoral research positions who have gone on to become independent investigators.
  • The primary mentor should have sufficient research support to cover the costs of the proposed research project in excess of the allowable costs of this award.Funds available for this project should be explicitly described by the mentor or individual providing funds beyond those available through this award.
  • The primary mentor's statement should provide, in narrative form: 1) information on his/her 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 applicant ( 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 his/her mentor(s); and 6) when appropriate, a statement affirming any resources and reagents that can be taken by the applicant to the extramural phase of the award. In addition, the mentor must specifically identify what elements of the proposed research project the K22 applicant can take when he/she transitions to the extramural phase and provide assurance that he/she will not directly compete with the applicant 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 his/her 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.
  • 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. 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): 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.  Unless also listed as senior/key personnel, these individuals do not need to 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 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 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 describe explicitly (i.e. with time requirements) the non-K22 commitments of the candidate. Note that the time requirements should be described in the following terms: 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.

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

The following additional instructions apply:
  • 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.

PHS Assignment Request Form

All instructions in the SF424 (R&R) 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 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

4. Submission Dates and Times

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.

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.

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 SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

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. See Section III of this FOA for information on registration requirements.

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. 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.

Post Submission Materials

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.

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.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

  Candidate

  • Has the candidate demonstrated a commitment, based on prior and current activities, to becoming a successful independent investigator who will contribute significantly to an NINDS-related research field?
  • Will the research experiences in the mentored phase prepare the candidate to implement successfully the independent phase research project?
  • Has the candidate demonstrated that he/she can perform significant, high quality scientific research?
  • Did the candidate's prior research and training experiences prepare him/her to pursue the proposed research using state-of-the-art approaches?

Career Development Plan/Career Goals and Objectives

  • Are there plans for evaluating the awardee’s progress and are they adequate and appropriate for guiding the applicant 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 applicant'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?
  • If proposed, will the clinical trial experience contribute to the 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 appropriate?
  • 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 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 awardee’s progress toward independence?
  • Do the applicant 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 applicant in his/her 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 his/her expectation for the transition of the candidate to the extramural phase of the award, including the projected timing of this transition, and the guidance he/she will provide to facilitate this transition?
  • Does the mentor clearly and explicitly describe the elements of the project the candidate can take with him/her 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 he/she 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 his/her 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?
  • 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

  • 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 his/her 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?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Revisions

Not Applicable

Additional Review Considerations

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 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).

Training in the Responsible Conduct of Research

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

  • 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 NINDS National Advisory Council.

The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities

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 VI. Award Administration Information

1. Award Notices

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 recipient’s business official.

Recipients 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.

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 the award conducted in the NIH intramural program. The awarding Institute will transmit to the successful candidate an approval letter which 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.

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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, 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 of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

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.

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 theFederal 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 and 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.

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 awardee's progress during the intramural phase will be determined from a progress report included in the request to transfer the award (see below). The awardee'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 awardee 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 grantee organization. However, to avoid potential problems in activation, applicants are strongly encouraged to contact the Director, Office of Training, Career Development and Workforce Diversity, 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.

The extramural institution must provide the space, facilities, resources, and other support needed to conduct the proposed research, as well as the required protected research time for neurologists and neurosurgeons, at least for the duration of the K22 award. Any start-up package and other institutional support must be described in detail and must be comparable to that given to other faculty recently hired into the equivalent faculty position. The K22 sponsoring institution must describe the candidate's academic appointment. The K22 institution must describe the awardee's ability to apply for and secure independent research grants, including an NIH RPG or equivalent.

These materials should be sent, via an email attachment (preferably pdf format), directly to both the Scientific Contact and Grants Management Contact listed below.

An institutional commitment agreement will be required at the time of activation of the extramural phase of the award. This agreement should satisfy the criteria described in the Career Development Award Section of the SF424 Application Guide.

The K22 award is intended to facilitate successful transition to an independent dual, clinician-scientist career. Moreover, funding of the 5th year of the K22 award requires the candidate to submit a competitive NIH R01 or R21 application by the end of the 4th year of the K22. Consequently, a requirement for approval of the transfer of the K22 to the extramural institution is the commitment of the extramural institution, including the provision of adequate resources, for successful progress of the candidate to research independence.

Candidates for whom transfer to the extramural institution is not approved will receive written notification from the awarding component, communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the transfer application.

Although the financial plans of the NIH Institute or Center provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

3. 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. 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.

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 recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

4. Evaluation

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.

Section VII. Agency Contacts

.

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

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Scientific/Research Contact(s)

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

Peer Review Contact(s)

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Email: nindsreview@nih.gov

Financial/Grants Management Contact(s)

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

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.

Authority and Regulations
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.


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