Career Development Programs (K-Series)
NIMH is committed to research training and career development that prepares individuals to conduct innovative research in areas of program relevance that will advance the mission of the Institute. NIMH strongly encourages prospective applicants to consult with the NIMH Research Training and Career Development representative in the appropriate Division well in advance of preparing an application.
The Program Officer will discuss the relevance of your proposed research to the Institute's research priorities, provide guidance on the proposed research and training plans, and help identify the most appropriate funding opportunity for your research and training.
Awardees should direct programmatic questions to the responsible Program Officer and grants management questions to the Grants Specialist. Both individuals’ contact information is available in the Principal Investigator’s eRA Commons account.
* The NIH RePORTER is an electronic tool that allows users to search a repository of both intramural and extramural NIH-funded research projects.
Additional Career Development Program Guidance
Instruction in the responsible conduct of research
Instruction in the Responsible Conduct of Research is an integral component of any career development program. Successful completion of such instruction is required during Year 01 of any NIMH career development award. Instructional details must be reported in the Year 02 Progress Report. Information about this policy can be found on the Guidance for Responsible Conduct of Research Training Requirements.
Effort on career development awards
Each program requires recipients to devote a defined, minimum percentage of full-time professional effort to research and career development activities during the award period. See Table of K Parameters for information on minimum effort requirements for each K program.
Individual mentored career development support after institutional mentored career development support
The institutional mentored career development programs, such as the K12 program and the KL2 component of the Clinical and Translational Science Award (CTSA) program, typically support individuals for 2-3 years, which may not be enough time for an individual to transition to research independence. As a result, if an applicant were initially supported by an institutional mentored career development program, the NIMH will consider allowing such an individual to receive, in aggregate, up to six years of mentored K support from a combination of institutional and individual mentored career development awards.
The total period of mentored support is expected to provide sufficient time for transition to research independence. An applicant is expected to justify the need for additional mentored K support in their individual mentored K application. All other individual mentored career development awards still apply.
Research effort during the last two years of individual mentored career development support
NIMH mentored career award recipients are expected to apply for independent research support during the later years of the mentored career award. During the last two years of mentored K support (K01, K08, K23), NIH policy (NOT-OD-08-065 and NOT-OD-18-157 ) permits award recipients to reduce the level of effort required for their career development award to no less than 6 person-months (i.e., 50%) and replace that effort with effort as a PI on a peer-reviewed research award or as a project leader on a competing multi-project award from NIH or any Federal agency, if programmatic policy of the other agency allows such an arrangement, and provided that the PI remains in a mentored situation.
This NIH policy permits those mentored K award recipients who are ready to compete for research grants to continue to benefit from the period of protected time offered by the mentored career development award. Note that the total level of research commitment must remain at 9 person-months or more for the duration of the mentored K award. This policy does not apply to K99 awardees.
Change of institution
NIMH will consider transfers from one institution to another, with prior approval of the responsible Program Officer. However, NIMH will consider transfer from one institution to another for K99 awards only when the K99 PI and his/her mentor are transferring to the same institution. No transfer will be allowed for any award: with less than six months remaining in the project period at the time the change of institution application is submitted; during a period of administrative extension; or that has terminated.
Early consultation with NIMH staff is critical for timely transfer of the grant to the new institution. Potential transfer applicants should contact the NIMH Program Officer named in the eRA Commons for guidance prior to submitting the change of institution application.
A change of institution application must be submitted in response to PA-24-254 by the authorized organizational representative at the new institution. The instructions in this funding announcement should be followed. This application must be submitted at least three months before the desired effective date to allow the necessary time for staff review. Applications requesting a change of institution that are submitted after July 15th annually will generally not be reviewed until the next fiscal year (after October 1st).
Transfer of career awards to another institution may be approved, without peer review, under the following circumstances. The Program Officer will assess the degree to which the goals of the original, peer-reviewed application will be met at the new institution. Critical among these considerations will be the continued capacity to carry out full-time research; the potential to contribute significantly to the scientific field of study as evidenced by research productivity; clear and high likelihood that the new environment will contribute to scientific development and productivity; scientific and technical merit of the research plan and its consistency with the career development plan; the new mentor's research and mentoring qualifications in the scientific area of study (if applicable); and the strength of the institutional environment and commitment. After consideration, the Program Officer will recommend either approval or disapproval of the requested transfer to the NIMH Grants Management Specialist.
NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-19-027 ). The application’s Protection of Human Subjects section and Data and Safety Monitoring Plan should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by NIMH for consistency with NIMH and NIH policies and federal regulations. NIMH requires reporting of recruitment milestones for extramural-funded clinical research studies proposing to enroll 150 or more participants per study, and all clinical trials, regardless of the number of participants, as noted in NOT-MH-19-027 . This expectation will be stated in the NoA.
NIMH expects the registration and results reporting for all NIMH-supported clinical trials, regardless of whether they are subject to FDAAA (see Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov ). This expectation will be stated in the NoA.
General NIH clinical trial information
The NIH definition of a clinical trial was revised in 2014 in anticipation of stewardship reforms to ensure a clear and responsive definition of a clinical trial. NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes” (NOT-OD-15-015 ).
The NIH definition of a clinical trial applies to a wide range of clinical trials (mechanistic, exploratory/development, pilot/feasibility, interventional, behavioral). Many clinical studies that were not considered to be clinical trials under the pre-2014 classification scheme now fall under the revised NIH definition of a clinical trial. Resources (case studies , FAQs , and a decision tool ) are available to help applicants determine if their clinical study is considered to be a NIH-defined clinical trial.
NIH requires that all applications involving one or more independent clinical trials be submitted through a Notice of Funding Opportunity (NOFO) specifically designated as ‘Clinical Trial Required’, ‘Clinical Trial Optional’, or ‘Basic Experimental Studies with Humans’ (see Clinical Trial-Specific Funding Opportunities ).
NIMH information on clinical trials
The following guidance is for individuals developing NIMH mentored research career development award (K99/R00, K01, K08, K23) applications in the area of intervention development and testing, as well as research focusing on the effectiveness of therapeutic, preventive, and services interventions. It is important that mentored career development applicants conducting intervention research develop their research plans to be consistent with the NIMH emphasis on an experimental therapeutics approach to intervention development and testing (see Support for Clinical Trials at NIMH).
In this approach, throughout all phases of intervention development and testing (i.e., from the development of novel interventions through effectiveness testing) projects should be designed to assess the relationship between underlying disease processes and the mechanisms of action through which an intervention produces therapeutic change.
As part of this approach, applications must include an examination of a hypothesized mechanism of action or proximal target based on evidence of disease processes and a clear hypothesis about how an intervention directed at changing that mechanism or proximal target could lead to improvement of a clinical endpoint or endpoints (e.g., symptom, symptom cluster), as well as address issues of safety and tolerability. For a more complete description of abovementioned approaches, applicants are strongly encouraged to review the associated NIMH funding opportunity announcements listed below.
The structure and budgetary constraints associated with a mentored career development award will limit the scope of the research that can be achieved. Applicants will need to thoughtfully balance the feasibility of developing their project within these constraints. Potential approaches may include:
- Studies testing whether a novel intervention engages and alters the hypothesized mechanism of action or proximal target. Within this context, the term “target” refers to a factor that an intervention intends to modify, based on a hypothesis that modification of that factor will result in improvement of symptoms, behavior, or functional outcomes. The specific activities and milestones appropriate for the mentored career development award application focusing on target engagement and evaluation will depend on the type of intervention (behavioral, drug, and/or device) under study and its stage of development. Applicants should consider assessing target engagement and change using multiple units of analysis (e.g., genetic, neural circuits, physiology, behavior, self-report, etc.). Determining which units of analysis to use will depend on the scientific hypothesis proposed, and scientific feasibility.
- Studies using a phased approach where phase 1 would support the testing and validating of the intervention’s mechanism of action (i.e., target identification and engagement), followed by additional studies relating the mechanism of action to functional or clinical effects (phase 2). Studies not using a phased approach must still include a mechanism of action (i.e., treatment target) as part of the study. Applicants that do not propose assessment of a mechanism of action and its engagement as part of the research protocol will be viewed as low program priority with the new NIMH intervention development requirements. For a more complete description of this phased intervention development approach for a mentored career development award please refer to the R61/R33 information on the Clinical Trials Funding Opportunity Announcements – Applicant Information page .
- Pilot Studies of novel interventions, where there is already evidence of target engagement, for an evaluation of feasibility and acceptability of the intervention in a patient population, as well an evaluation of the relationship between change in the targeted mechanism and change in functional or clinical status. For a more complete description of this intervention approach for a mentored career development award please refer to the Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R33 Clinical Trial Required) .
- Research on the effectiveness of therapeutic, preventive, and services interventions (e.g., in broader target populations or community settings), including pilot studies that evaluate the feasibility and acceptability of approaches, as a pre-requisite to a larger-scale study, should be designed to explicitly address and re-confirm whether the intervention targets and associated change mechanisms identified under more controlled, efficacy conditions are operative in the effectiveness context. For a more complete description of this experimental approach please refer to Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34- Clinical Trial Required) .
For applications submitted after January 25, 2023, the NIH Data Management and Sharing (DMS) policy applies to some career development awards (e.g., K01, K08, K23, K99, K22). Under the DMS policy, NIH expects investigators and institutions to plan and budget for the managing and sharing of data, submit a DMS plan for review when applying for funding, and comply with the approved DMS plan (see the 2023 Final NIH Policy for Data Management and Sharing and Data Management and Sharing Resource page ).
The NIMH data sharing policy is detailed in NOT-MH-23-100 , and additional information for applicants and awardees can be found on the NIMH Data Management and Sharing for Applicants and Awardees website. Of note, K awardees are not required to deposit their data into the NIMH Data Archive.