Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Reissue of PAR-18-755
None
93.242
The primary goal of the NIMH Career Transition Award for Tenure-Track Intramural Investigators (K22) Program (hereafter abbreviated as the NIMH Career Transition K22 Program) is to provide support for career intramural investigators at NIMH who aim to transition from the Division of Intramural Research Programs (IRP) to an independent research faculty position in the extramural community. Applicants should have a demonstrated record of meritorious research in mental health-related fields.
This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial.
Not Applicable
Standard dates apply by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
Standard dates apply
Standard dates apply
Standard dates apply
Not Applicable
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.
The objective of the Career Transition Award (K22) is to provide support to outstanding, newly trained basic or clinical investigators to develop their research skills through a two phase program: an initial period involving an intramural position at the NIH and a subsequent period of support at an extramural institution.
The 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 Program is to assist investigators in the NIMH Division of Intramural Research Programs (IRP) in achieving their research career goals. The specific goals of this program are to: 1) support tenure-track scientists conducting research in the NIMH IRP 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 IRP investigators to mental health research and to strengthen further the innovative research that is conducted in the IRP, the NIMH IRP must maintain a steady turnover of tenure-track investigators. In seeking to attract outstanding, early-stage scientific talent to the NIMH IRP, there is a need to maintain a steady flow of IRP investigators to the extramural community. To foster and aid that transition, the NIMH Career Transition Program will provide fiscal support for up to three years to enable tenure-track investigators in the IRP to transition their research programs to the extramural community. This Program should enable 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.
Nature of the Career/Research Transition Opportunity
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 IRP 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 tenure-track investigator in the NIMH IRP. The research proposed must span both phases of the award. 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 meritorious score after peer review of the initial application, the candidate will be notified in writing of NIMH's initial 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 while continuing their independent research program in the IRP. 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 allows 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.
Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Note: Applicants should not submit proposals for a clinical trial experience.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications
The total project period may not exceed 3 years.
NIMH will contribute funds for up to 6 person-months' effort per year toward the salary of the career award recipient during Phase 2 of the award. The funds for salary and fringe benefits are included within the annual, direct cost cap of $300,000 for the NIMH Career Transition Award (K22) Program. The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.
NIMH will contribute $300,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.
Salary for mentors, secretarial and administrative assistants, etc. is not allowed.
Eligible Applicant Organizations for Phase 1:
Eligible Applicant Organizations for Phase 2:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
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. Eligibility of organizations, other than institutions of higher education, for Phase 2 depends on the nature of the appointment, and the ability of the PD/PI to conduct independent research and apply for NIH research (R01 or R01-equivalent) grants. Only successful Phase 1 Candidates may proceed to Phase 2.
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.
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 IRP and must have been a tenure-track investigator in the NIMH IRP for at least five years. At the time an application is submitted (or resubmitted), individuals are NOT eligible to apply if they are negotiating and/or have accepted an independent faculty position, or its equivalent, in academia, industry, or elsewhere.
Candidates for the K22 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.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:
Phase 2 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.
After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.
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.
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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 Application Guide and the Table of Page Limits must be followed.
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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 must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Plan(s):
Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.
All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:
Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix
All instructions in the SF424 (R&R) Application Guide must be followed.
Candidate Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Candidate Information and Goals for Career Development
Candidate’s Background
Career Goals and Objectives?
Candidate’s Plan for Career Development/Training Activities During Award Period
Research Plan Section
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy
Training in the Responsible Conduct of Research
Letters of Support from Collaborators, Contributors and Consultants
Environmental and Institutional Commitment to the Candidate
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Description of Institutional Environment
Institutional Commitment to the Candidate’s Research Career Development
Other Research Plan Sections
Resource Sharing Plan(s)
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification: To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this FOA are expected to share those data via the NIMH Data Archive (NDA) (https://ndar.nih.gov/; see NOT-MH-19-033), as appropriate. Established by the NIMH, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research results, tools, and supporting documentation.
Investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://ndar.nih.gov/contribute_data_sharing_regimen.html. The resource sharing plan should be formulated in accordance with the NDA Data Sharing Terms and Conditions.
Appendix:
Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
Reference Letters
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
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.
Generally Phase 1 is for 18 months; however, award recipients may transition earlier than 18 months when the recipient has been offered an acceptable position. It is expected that award recipients will generally benefit from a Phase 1 period of no less than 12 months in duration before transitioning to Phase 2. If an applicant is negotiating and/or has accepted an independent faculty position, or its equivalent, in academia, industry, or elsewhere prior to notification of the Institute’s intent to make a K22 award, then no award will be made.
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 Phase 2 K22 award may not be approved should the PD/PI not have applied for independent research grant support during year 2 of this award.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Use of Common Data Elements in NIH-funded Research
NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following: the goal of this NIMH Career Transition (K22) Award Program is to facilitate the transition of a tenure-track intramural investigator from the NIMH IRP (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 evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.
Reviewers should provide their assessment of the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Candidate
Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring
Research Plan
Consultant(s), Collaborator(s)
Environment & Institutional Commitment to the Candidate
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Revisions
Not Applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Training in the Responsible Conduct of Research
All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’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 Phase 1 of this NIMH K22 award conducted in the NIH intramural program. The NIMH will transmit to the successful candidate an approval letter that will include the terms and conditions of the NIMH Phase 1 K22 award, as well as expectations for the transition to Phase 2 of this 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 Phase 2 K22 award may not be approved should the PD/PI not have applied for independent research grant support during year 2 of this 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, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ( K ) Awardees section of the NIH Grants Policy Statement.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to theFederal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Transition to the Independent Phase
Transition to Phase 2
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. Generally Phase 1 is for 18 months; however, award recipients may transition earlier than 18 months when the recipient has been offered an acceptable position. It is expected that award recipients will generally benefit from a phase 1 period of no less than 12 months in duration before transitioning to phase 2. If an applicant is negotiating and/or has accepted an independent faculty position, or its equivalent, in academic, industry, or elsewhere prior to notification of the Institute’s intent to make a Phase 1 K22 award, then no Phase 2 award will be made. In order to submit a Phase 2 application, an individual 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:
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:
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 Phase 2 K22 award if the institutional commitment is deemed inadequate.
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.
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor's Report is not applicable for this K22.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Ashlee Van't Veer, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3107
Email: [email protected]
Additional Scientific/ Research Contact(s)
See http://www.nimh.nih.gov/funding/training/contacts-for-research-training-and-career-development-programs.shtml for current Scientific/Research Contacts
Nick Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]
Terri Jarosik
National Institute of Mental Health (NIMH)
Telephone: 301-443-3858
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.
Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.