Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, includingSupplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In addition to this opportunity, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

The objective of the Career Transition Award (K22) is to provide support to outstanding basic or clinical investigators to develop their independent research skills through a two phase program: an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. The award is intended to facilitate the career development and establishment of a research program by the candidate in order to promote a successful, independent research career.

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. Neurologists must devote a minimum of 9 person months (75% full-time professional effort) towards their research career development. Consistent with extramural NINDS K08 and K23 awards for clinician-scientists, neurosurgeons must devote a minimum of 6 person-months (50% full-time professional effort) each year to their research career development for the entire duration of the award. 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 5 year 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 order to transition to the extramural phase, awardees must obtain a faculty position at an academic institution. This position should either be a tenure-track or equivalent position, or a faculty position with a strong institutional commitment to facilitate progress towards a successful dual career as clinician and research scientist in a secure faculty position. In order to obtain the 5th year of K22 funding, awardees must submit a competitive NIH R01 or R21 application, as PD/PI, by the end of the 4th year of the K22 award.

This K22 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 portion of the project proposed should 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 expertise in experimental design and statistics. Regardless of 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, 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. Research plans should be appropriate for conduct at both intramural and extramural institutions, with a feasible transition between the two phases and sufficient progress in the research program to allow submission of an NIH R01 or R21 by the end of the 4th year of the K22 award.

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

Only NIH intramural laboratories are eligible to apply for the intial mentored phase of the K22 mechanism on behalf of intramural candidates. They are not eligible to apply for phase 2 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.

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.

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.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number 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.

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups 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 this award must have a clinical doctorate (including MD, DO or equivalent clinical doctoral degree), or a combined clinical and research doctoral degree.

Individuals must be licensed neurologists or neurosurgeons within the NINDS Intramural Program to be eligible (see specific information available for intramural candidates on the Electronic Submission Intranet link available only to users internal to NIH).

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

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

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Once they transition to the extramural phase of the award, recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as soon as they are ready (please see NOT-OD-08-065 for special conditions). NINDS K22 award recipients must submit a competitive NIH R01 or R21 by the end of the 4th year of the K22 to obtain the 5th year of K22 funding.

At the time of award, the candidate must have a full-time appointment in the NINDS intramural program. Candidates are required to commit a minimum of 9 person-months (75% of full-time professional effort) to their career development and research training during the the entire award period. Neurosurgeons must devote a minimum 6 person-months (50% of full-time professional effort) to research and career development activities. 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. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for the conduct of the proposed 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 such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. Importantly, and especially because awardees will begin the award at NIH intramural, applicants should recruit at least one mentor with recent, successful experience in writing NIH grant applications.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

Project Summary/Abstract

Include a description of the research proposed for the intramural phase and the research proposed to continue in the extramural phase.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed.

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Candidate Information

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

Candidate s Background

• Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIH.
• Describe current training and research efforts of the candidate.
• Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
• 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 letters of reference.
• Describe all of the candidate's professional responsibilities in the grantee institution and elsewhere and describe 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 the candidate’s current and long-term research and career objectives.
• Describe a systematic plan that shows a logical progression from prior research and training experiences to the research and training experiences that will occur during the K22 award period and then to independent investigator status.

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 non-research 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 involvement in other research projects outside of the minimum required commitment of 9 person-months (75% full-time professional effort) for neurologists; 6 person-months (50% full time professional effort) for neurosurgeons) to the K22 award. The 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 an independent research investigator.
• Describe planned didactic components, workshops, meetings, collaborative activities and other relevant research and educational activites that will contribute to the research career development of the candidate. Describe activities that will provide an solid understanding of the fundamentals of experimental design, data analysis and scientific rigor.
• Describe the plan for obtaining a practical knowledge of the administrative skills associated with an independent research career, 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.
• A timeline, including the expectations for publication of results, 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.
• Although not required, 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. If such a team is formed, applicants should describe 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 the applicant expects to obtain scientifically, clinically or both, during the intramural phase, that will enable successful transition, 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.

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).
• The plan must address the five, required instructional components outlined in the NIH policy: 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 instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019.
• Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.

Statements and Letters of Support

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), 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, directing, monitoring, and executing the proposed program. The candidate may also nominate co-mentors as appropriate to the goals of the program.
• The primary mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training future 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, and should describe specifically the funds that are available to the candidate's project.
• 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 training 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 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 applicable, the specific contributions of the co-mentor should be described by both the applicant and the co-mentor.
• 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 candidates professional effort.
• If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. All mentors should describe 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 describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings.
• 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 primary mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by each collaborator and/or consultant. These statements should be written by the collaborator and/or consultant, and confirm their participation in the project and describe their specific roles. Collaborators and consultants are not required to submit biographical sketches but may if deemed helpful. If they aren't provided, information should be provided that clearly documents expertise in the proposed area(s) of collaboration/consultation. Any other opportunities for the candidate’s professional growth should also be documented in these statements.
• If an advisory committee is proposed, statements must be provided by each member of the proposed committee. These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute. Biographical sketches are not required from these individuals, but may be included if deemed helpful.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), 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 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, technians 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 the award. The sponsoring institution must provide the candidate with the appropriate facilities and other resources to carry out the proposed Research Plan.
• The sponsoring institution must provide assurance that appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan will be provided.
• If special resources available only at NIH intramural 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.

Research Plan

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series), must be followed, with the following additional instructions:

Research Strategy

• The research strategy must span both phases of the award. The candidate should clearly indicate the research planned for each phase. The entire K22 period is intended to be mentored. If a transition to independence is expected to occur during the 5 year award period, the candidate should explain what must be accomplished during the mentored phase and what will be pursued once independence is achieved. The application should also describe the anticipated timeline of the research.
• The application should state the significance, innovation and approach of the proposed research during both phases of the award. The research strategy should provide a detailed rationale, experimental approach, and expected/alternative outcomes for the proposed studies. The application should provide a clear description of how the data will be analyzed, power calculations, potential problems that may be encountered and how the approach will be modified should these potential problems materialize.
• 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 intramural phase 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 must describe the relationship between the mentor’s research and the candidate’s proposed research plan. 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 include a description of how the mentored phase research will lead to an independent research program.
• 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, R21 or equivalent by the end of the 4th year of the K22 award.
• The application should describe collaborative arrangements required for the research, and how these collaborative arrangements will be continued after the transition to the extramural phase of the award.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the NOT-OD-11-079). 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.

Part I. Overview Information contains information about Key Dates. 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.

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.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Important Update: See NOT-OD-16-012 and NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

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

Candidate

• Does the candidate have the potential for becoming a successful independent investigator who will contribute significantly to a chosen health-related research field?
• Will the research and career development experiences in the intramural phase prepare the candidate to successfully implement the research project during the extramural phase?
• 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/Plan to Provide Mentoring
• Is the career development plan 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?
• Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated training and research objectives for achieving research independence?
• 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 competive NIH R01, or R21 application will be submitted by the end of the 4th year of the K22 award period?
• Does the career development plan adequately address skills and experiences required for successful independent research other than those directly related to the research (e.g. grant writing, networking, oral presentation, leadership, lab management, etc.)
• Is there adequate assurance that the candidate will receive at least 75% protected time (50% for neurosurgeons) for research career development? Are the non-research commitments of the candidate clearly described in terms of the actual time commitment required to fulfill them?

Research Plan

• 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?
• Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of prior training and experience?
• Is the proposed research relevant to stated career objectives?
• Does the research plan describe methodology to achieve adequate scientific rigor?
• Will the research project address an innovative hypothesis, challenge existing paradigms or otherwise make a 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 data analysis, 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?

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

• Are the mentor's research qualifications in the area of the proposed research appropriate?
• Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement?
• 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?
• 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?
• Are the consultant's and collaborator's roles specified, and are they qualified, appropriate and sufficient, along with the mentor(s), to fulfill the needs of the candidates research and career development goals?
• Is active/pending support for the proposed research project appropriate and adequate?
• Does the mentor, or member of the mentoring team, have adequate experience to guide the candidate in skills required to obtain research funding?
• Is the mentor currently a productive scientist? Is support for the proposed research project appropriate and adequate?
• Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
• 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 portion 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?
• 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?
• Environment & Institutional Commitment to the Candidate
• Are there adequate and appropriate research facilities and educational opportunities, including collaborating faculty?
• Is there clear commitment of the sponsoring institution to ensure that the required effort of the candidate will be devoted directly to the research training, 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?
• 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 to demonstrate that they will consume 25% or less of the candidate's full time effort?

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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

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

Renewals

Not Applicable

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.

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Will receive a written critique.

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

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

Availability of funds.

Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.

Transition from the intramural phase to the extramural phase is not automatic, and requires administrative approval by NINDS. 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. 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. 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, is essential. 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 an 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 who obtain K22 support 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 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 new face page signed by the Phase II institutional representative.
• An updated 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.
• A letter from the Department or Division Chairperson that describes the sponsoring institution’s commitment to the candidate and to the candidate’s scientific independence (or progression to 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; description of the candidate's non-research obligations, including the time commitment to these obligations; institutional commitment to fostering the career development of the candidate.
• In addition to the narrative provided by the mentor (described above), a biosketch and description of mentor's funding should be provided.
• Although the protected time requirement only extends to the end of the K22 award, the extramural institution is encouraged to continue to provide adequate protected time beyond the K22 award period to allow the applicant to successfully launch a vigorous, independent research program. Any such allowance is an encouraged part of the extramural application.
• 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. If the candidate's position is not a tenure-track or equivalent position, the institution must provide a detailed explanation of the plans and opportunities for promotion, and the expectations for the K22 awardee with regard to promotion.
• A new budget page, 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. If previously unnamed consultants or collaborators are added, letters of commitment from these consultants/collaborators should be included.
• 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.
• If funding is required to conduct the research beyond that provided in the K22 award, the source of available funds should be identified, and an appropriate letter attesting to the availability of these funds provided.

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 (minimum of 9 person-months: 75% of the candidate’s full time professional effort), 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.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

Stephen Korn, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-4188
Email: [email protected]

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9223
Email: [email protected]

Tijuana Decoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

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

Awards are made under the authorization of 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 Parts 74 and 92.