Required Application Instructions

It is critical that applicants follow the 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), 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 National Institutes of Health (NIH) believes that the creativity and innovation of independent investigators at all career stages play an integral role in addressing our Nation's biomedical, behavioral, and clinical research needs. The intent of the NIMH Career Transition (K22) Program is to assist investigators in the NIMH Division of Intramural Research Programs (DIRP) in achieving their research career goals. The specific goals of this program are to: 1) support tenure-track and tenured scientists conducting research in the NIMH DIRP who aim to transition to independent research positions in the extramural community where they intend to continue already successful biomedical research careers as independent scientists; and 2) foster the further career advancement of these independent scientists and enable them to expand their potential to contribute significantly to mental health-related research.

In order to maintain and expand on the many contributions of DIRP investigators to mental health research and to strengthen further the innovative research that is conducted in the DIRP, the NIMH DIRP must maintain a steady turnover of tenured and tenure-track investigators. In seeking to attract outstanding, early-stage scientific talent to the NIMH DIRP, there is a need to maintain a steady flow of DIRP investigators to the extramural community. To foster and aid that transition, the NIMH Career Transition (K22) Program will provide fiscal support for up to three years to enable tenured and tenure-track investigators in the DIRP to transition their research programs to the extramural community. This Program should enable tenured and tenure-track intramural investigators to compete successfully for academic positions, make successful career changes, and compete for R01 or R01-like research grant support from the NIH and other agencies.

Each application to the NIMH Career Transition (K22) Program must reflect the individual needs of the Candidate (PD/PI). The K22 award is conducted in two phases: Phase 1 takes place at the NIMH DIRP while Phase 2 takes place at the domestic, extramural institution to which the Candidate will transition. The application will be submitted for peer review of scientific and technical merit while the Candidate is a tenured or tenure-track investigator in the NIMH DIRP. The outcome of this review will be a key determinant of whether the application will be supported. However, it is the Phase 2 application that will be awarded. If the Candidate receives a fundable score after peer review of the initial application, she/he will be notified in writing of NIMH's commitment to make an award. The Candidate will then have a period of no more than 18 months (Phase 1) to identify a suitable, independent research position at a domestic research institution/organization and negotiate a start-up package. As soon as negotiations between the Candidate and the institution are complete, the Phase 2 application must be submitted by the extramural institution for administrative review and award (see below).

Phase 2 of the NIMH Career Transition (K22) award will provide up to three years of support to conduct research as an independent scientist at a domestic, extramural institution/organization to which the Candidate has been recruited, been offered and has accepted an independent research position. The institution sponsoring the Phase 2 award must demonstrate a commitment to provide the environment, resources, and at least 6 person-months (equivalent to 50% full-time professional effort) of protected time during the Phase 2 award period for the Candidate to conduct the proposed research. This commitment will enable the Candidate to maintain and develop further an independent research program and to prepare a competitive application for research grant support (R01) during the K22 award period. NIMH K22 award recipients are expected to apply for NIH or other independent research grant support during the second year of the extramural phase (Phase 2) of the K22 award.

The NIMH Career Transition (K22) application is thus submitted in two phases in order to allow the project to be peer reviewed for scientific and technical merit (Phase 1) before the Candidate begins an independent research position at an extramural institution (Phase 2). Phase 2 funding is NOT automatic and is subject to several conditions described in Section VI. Transition to Phase 2. Once the independent research position has been secured, NIMH will administratively review the Phase 2 application to ensure that all programmatic requirements are met prior to award.

Candidates are encouraged to consult with the appropriate staff person in Section VII - Agency Contacts, prior to submitting an application, to discuss eligibility and program requirements.

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.

Eligible Applicant Organizations for Phase 1:

For Phase 1 of the NIMH Career Transition (K22) Program, only NIMH intramural laboratories are eligible to apply on behalf of tenured or tenure-track investigators in the NIMH DIRP.

Eligible Applicant Organizations for Phase 2:

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)

The application for the extramural phase (Phase 2) of the award will be submitted by the domestic, for-profit or non-profit, academic institution/organization (e.g. university, college, hospital, and laboratory) at which the Candidate has been recruited, offered and has accepted an independent research faculty position. Only successful Phase 1 Candidates may proceed to Phase 2.

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (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 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.

At the time an application is submitted (or resubmitted) for peer review, the PD/PI must currently be conducting research in the NIMH DIRP and must have been a tenured or tenure-track investigator in the NIMH DIRP for at least five years. Individuals are NOT eligible to apply if they have already accepted an independent faculty position, or its equivalent, in academia, industry, or elsewhere.

Candidates for this award must have a clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD, or equivalent doctoral degree), or a combined clinical and research doctoral degree.

Only individuals affiliated with an NIMH Intramural Laboratory may apply (specific information is 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.

Candidates may submit research project grant (RPG) applications concurrently with the K application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the K22 application. K22 award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-08-065.

At the time of the Phase 2 award, the candidate must have a full-time appointment at the academic institution. Phase 2 awardees are required to commit a minimum of 50% of full-time professional effort (i.e., a minimum of 6 person-months) to their mental-health research. Candidates may engage in other duties as part of the remaining 50% 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. 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 .

Institutional Environment

Both Phase 1 and Phase 2 applicant institutions must have strong, well-established records of research and career development activities and faculty qualified to serve as collaborators and/or consultants in biomedical, behavioral, or clinical research.

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, with the following additional instructions:

Project Summary/Abstract

Include a description of your current research and the research you propose to conduct during Phase 2 of the award.

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, behavioral, or clinical research field relevant to the mission of the NIMH.
• Describe the Candidate's prior training and research, including publications, inventions, and research interests and experience.
• Describe the Candidate's current, professional responsibilities (e.g. teaching, service, editorial review service, role in professional societies) and their relationship to the activities proposed during the transition award.
• Present evidence of the Candidate’s success as an independent investigator and his/her potential to make future contributions to the chosen field of research. Describe any prior and current research support that the Candidate has obtained.

Career Goals and Objectives

• Describe the Candidate’s current and long-term research and career goals and objectives, identifying the specific goals and objectives for the award period and their relationship to the stated long-term goals and objectives.
• Explain how the award and associated transition to an extramural research position will foster the Candidate's ability to make future contributions to the chosen field of research.

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

• Describe any new or enhanced research skills and knowledge that will be acquired during the career award period, and how these skills and knowledge will significantly enhance the Candidate’s ability to continue his/her research program as an independent scientist.
• Describe any new and/or enhanced professional skills that will be acquired during the career award period, e.g. refining grantsmanship skills as appropriate for an extramural scientist, and any other skills that may be germane to a future career in the extramural research community.
• Describe past and current collaborations during the Candidate’s tenure at the DIRP and how these collaborations contributed to the Candidate's training and research. Describe any collaborations that are anticipated to continue in Phase 2 of the award.

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:

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by each collaborator and/or consultant confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, 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.

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

• Document the quality of the research environment, and the strengths and extent of the research programs in the NIMH DIRP that are related to the candidate's area of research interest.
• Describe the scientific environment, including resources and facilities, that will be available to the Candidate during Phase 1 (intramural) of the K22.

Institutional Commitment to the Candidate’s Research Career Development

• The Scientific Director of the NIMH Division of Intramural Research Programs must provide a statement describing the DIRP's commitment to facilitate the candidate’s transition to a faculty position in the extramural community. The sponsoring institution (DIRP) must provide the Candidate with the appropriate facilities and other resources necessary to facilitate the Candidate's transition.

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 plan must span both phases of the award. The Candidate should clearly indicate the research planned for each phase.
• Describe a sound research project that is consistent with the Candidate s level of research experience and the objectives of his/her continued career advancement. The project should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach, as well as the Candidate's ability to carry out the proposed research.

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.

Important Note: Letters of Reference are not required for this K22 program. The Candidate should ignore any notification from NIH indicating that letters are required and were not received.

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.

In order to expedite review, applicants are requested to notify the NIMH Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

For this particular announcement, note the following: the goal of the NIMH Career Transition (K22) Award Program is to facilitate the transition of a tenured or tenure-track intramural investigator from the NIMH DIRP (Phase 1) to an extramural research faculty position (Phase 2). The first year of the Phase 2 award at the extramural institution is likely to include time to establish the new laboratory and to recruit, hire and train personnel.

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

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

Candidate

• Is there evidence that the Candidate is committed to a career in a biomedical, behavioral, or clinical research field relevant to the mission of the NIMH?
• Is the Candidate’s level of experience and competence commensurate with the purposes of this award?
• Has the Candidate demonstrated the ability to conceptualize and organize a long-term research program?
• Based on the Candidate’s demonstrated capacity to conduct independent research, evidence of past and present research productivity (contributions to the scientific literature), and success in obtaining independent funding, is the Candidate likely to continue to make significant contributions to the field?

Career Development Plan/Career Goals and Objectives

• To what extent are the Candidate’s career goals and objectives under this award consistent with the proposed career development/training activities?
• To what extent do the plans for career development and training activities during the award period position the Candidate for successful transition and to continue as an independent and productive scientist in the extramural community?

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?
• Is the research plan significant and of high quality? Does it have high potential for advancing the field of study?
• Does the proposed research demonstrate innovation and creativity, i.e. does the plan develop or employ novel concepts, approaches or methodologies, tools, or technologies for the specific area of research?
• Is there strong potential for the proposed research to contribute significantly to the mental health related research and scientific literature?

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?
• Has the Candidate demonstrated effective use of collaborations during his/her tenure in the DIRP?

Environment & Institutional Commitment to the Candidate

• Are there adequate and appropriate research facilities and educational opportunities, including collaborating faculty at the NIH?
• Are there unique features of the scientific environment that benefit the proposed research; e.g., useful collaborative arrangements or subject populations?
• Does the application document a high-quality research environment and a strong, well-established research program in the DIRP related to the candidate's area of interest? Based on the statement of the Scientific Director, NIMH, is there a strong and appropriate commitment by the DIRP to facilitate the Candidate's transition to a research faculty position in the extramural community?

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), convened by the NIMH in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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 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 National Advisory Mental Health 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.

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.

There will not be a formal Notice of Award (NoA) associated with the Phase 1 of the K22 award conducted in the NIMH intramural program. The NIMH will transmit to the successful Candidate an approval letter that will include the terms and conditions of the NIMH intramural K22 award, as well as expectations for the transition to Phase 2 of the award.

Award recipients are expected to apply for NIH or other independent research grant support during year 2 of the Phase 2 K22 award. Funding of year 3 of the K22 award may not be approved should the PD/PI not have applied for independent research grant support during year 2 of the award.

For Phase 2 awards, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

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

Transition from the intramural phase (Phase 1) to the extramural phase (Phase 2) is intended to be continuous in time. Support for Phase 2 is not automatic and is contingent upon obtaining an appropriate extramural position at an eligible institution, an appropriate start-up package, and the successful NIMH programmatic review of the faculty position the Candidate has accepted and the institutional commitment to the Candidate. From the date of the approval letter transmitted to the Candidate, the Candidate has a period of no more than 18 months (Phase 1) to identify a suitable, independent research faculty position at an eligible, domestic research institution/organization, negotiate a start-up package, and accept a position. In order to submit a Phase 2 application, individuals must have been offered and accepted a research faculty position at an eligible institution that has both appropriate infrastructure to support the proposed research program and a history of external research funding.

To avoid potential problems, Candidates are strongly encouraged to contact their NIMH Program Official as soon as plans to accept an extramural position develop. At that time, individuals should discuss plans for transition to, and the application for, the Phase 2 award. The application for the Phase 2 award should be submitted no later than 2 months prior to the proposed start date of the Phase 2 award.

The Phase 2 institution will submit an application on behalf of the Candidate using the PHS398 Application. The application must include:

• A new Form Page 1 (face page) signed by the Phase 2 institutional representative;
• An updated Form Page 2 (project summary page) that reflects current plans for the Phase 2 award;
• Form Page 3 (table of contents);
• Form Pages 4 and 5 (Budget for Initial and Entire Proposed Project Periods): Detailed budget pages for a non-modular budget and narrative justification for all requested funds for each budget year, including:
  • The name, role on project, and level of effort for all project personnel (salaried and unsalaried) and a narrative justification for each person;
  • The name and organizational affiliation of all consultants and a description of the services to be performed;
• Biographical Sketches for the PD/PI and any other Key Personnel;
• A new Resources Format Page including a description of specific resources committed by the sponsoring institution to support the Candidate’s research; research facilities; and the availability of appropriate educational opportunities, including collaborating faculty, if appropriate.
• Updated Specific Aims that reflect current plans for the Phase 2 project;
• An updated Research Plan (not to exceed 5 pages);
• A Letter of Institutional Commitment from the Department or Division Chairperson that describes the sponsoring institution's commitment to the candidate’s scientific independence (see additional details below);
• Updated Protections for Human Subjects and Inclusion of Women, Minorities and Children, Planned Enrollment Report and Cumulative Inclusion Enrollment Report (as appropriate);
• Updated Vertebrate Animals (as appropriate);
• Updated Biohazards and Select Agents (as appropriate);
• Letters of Support (e.g. Consultants): if previously unnamed consultants/collaborators are added, provide letters of commitment from these individuals;
• Updated Resource Sharing Plan (as appropriate);
• Updated plan for Instruction in the Responsible Conduct of Research; and
• A new checklist.

Letter of Institutional Commitment: A letter of institutional commitment is required at the time of the Phase 2 application and is typically provided by the Department or Division Chairperson. This letter should satisfy the criteria described in the Career Development Award Section of the SF424 (R&R) Application Guide. The letter should describe the following:

• 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. The start-up and salary package and other evidence of institutional support must be described and must be comparable to that provided to other, recently hired faculty who did not have a grant at the time they were hired. K22 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for faculty who are hired without grant support.
• Commitment to providing adequate resources, an appropriate institutional environment, and protected research time. Describe the quality and relevance of the institutional environment for the scientific and professional development of the Candidate. In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must demonstrate a commitment to the Candidate by providing a minimum of six person-months (50% full-time professional effort) of protected research time for at least the duration of the K22 award. Consequently, teaching, clinical duties and other non-research activities should be reduced during the K22 award period.
• Institutional commitment to fostering the Candidate's career development including how the institution will foster and support the Candidate's efforts to secure independent research grant (R01) support during the K22 award period. A plan is essential because NIMH K22 award recipients are expected to apply for NIH or other independent research grant support during year 2 of the K22 award. NIMH staff may review start-up packages and other commitments between the institution and Candidate. The applicant and/or the hiring institution are encouraged to discuss the nature of the institutional commitment with the NIMH Program Official prior to finalizing the offer and submission of the K22 application. NIMH will not make a K22 award if the institutional commitment is deemed inadequate.

The original application plus one copy (preferably in PDF format) are to be mailed (or e-mailed) directly to the NIMH Financial or Grants Management contact person listed in the PD/PI's eRA Commons account. The Phase 2 application will be evaluated by extramural NIMH Program staff for completeness and responsiveness to the program.

Applicants who are approved to transition will receive a Notice of Award reflecting the dollar amount and the recipient organization. Candidates who are not approved to transition will receive written notification from the NIMH communicating the rationale for the disapproval. This notification typically will be transmitted within 60 days of receipt of the Phase 2 application.

Although the financial plans of the NIMH 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.

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]

Erica Rosemond, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3107
Email: [email protected]

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3534
Email: [email protected]

Rebecca Claycamp
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
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.