Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Research Training and Career Development  website.

The objective of the Career Enhancement Award for Experienced Investigators (K18) is to provide support for experienced scientists who either wish to broaden their scientific capabilities or to make changes in their research careers by acquiring new research skills or knowledge. The purpose of this FOA is to provide such investigators with support for an intensive period of mentored research experience to acquire new research capabilities in research areas supported by the sponsoring NIH Institute(s)/Center(s). Such experiences will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; and/or 2) redirect their research programs in new trajectories; and/or 3) catalyze research collaborations in new research directions.  It is expected that this initiative will lead to new and/or augmented research programs competitive for NIH funding.

The goal of this K18 initiative is to enhance research workforce capacity as rapidly as possible by supporting a program that will help experienced investigators in related or complementary fields to gain research expertise in the field of firearm injury and mortality prevention. The purpose of enhancing workforce capacity is to increase the number and breadth of areas covered by funded NIH Research Project Grants (RPGs) that address the pressing public health challenge of firearm related injury and mortality. As noted above, applications should focus on enhanced research expertise and skills needed to conduct firearm injury and mortality prevention research as it relates to a range of types of violence and injury. Topics of focus include but are not limited to, accidental injury, intimate partner violence/dating violence, sexual assault, self-directed violence and suicide, child maltreatment, elder maltreatment, youth violence, hate crimes, community violence, and gang violence.

Background

Violence is defined by the World Health Organization as: “the intentional use of physical force or power, threatened or actual, against oneself, another person, or against a group or community, that either results in or has a high likelihood of resulting in injury, death, psychological harm, maldevelopment, or deprivation.” Both direct and indirect (e.g., witnessing) violent victimization events are associated with not only physical injury or mortality, but also a range of acute and chronic physical, mental and behavioral health conditions, such as obesity, cardiovascular disease, asthma, substance use disorders, and sleep disturbance.

When firearms are involved with violent events (including suicide, intimate partner violence, child or elder maltreatment, youth and gang related violence, sexual assault, and hate crimes), the risk for injury and mortality increases. Firearm related injury and mortality, in particular, constitute an urgent public health crisis with firearms being involved in almost 80% of homicides and over half of all suicides. The overall death rate by firearms increased 21 percent and the rate of homicide by firearms increased 35 percent from 2019-2022. Additionally, firearm-related suicides increased to their highest ever recorded level in 2022, and firearms remain the leading cause of death for children and youth ages 1-19 years.  Significant disparities by race, ethnicity, and poverty remain. For example, in 2022, firearm suicide rates among Black youth (ages 10-19 years) surpassed that of White youth for the first time. Homicide is also a significant cause of maternal mortality, as a recent study using national death certificate data found that pregnant women in the United States died by homicide (most often from partners) more often than they died of pregnancy-related causes. Other populations including members of sexual and gender minority (SGM) groups and people with disabilities bear a disproportionate burden of firearm related injury and mortality.

Thus, there is a critical need for a robust and well-equipped research workforce to better understand and address this critical public health issue. More investigators are needed to conduct community-engaged and informed research that provides an evidence base for communities, policy makers, service systems, and others involved in responding to the need for a range of empirically supported, effective, high-quality, cost-effective interventions to prevent firearm-related injury and mitigate its impact.

Program Objective

In addition to preparing the recipient   to apply for independent funding to conduct research on firearm injury and mortality prevention, it is expected that this initiative will also lead to new research collaborations that could lead to future NIH funding. This short-term (up to 24 months) period of mentored research experience should expand the investigator's current expertise and lead to new knowledge and skills and potential new collaborators. The research career enhancement experience may be conducted in a different department within the candidate's home institution or in a different institutional setting from the location where the candidate holds their primary appointment. Mentoring may occur in-person, virtually, or in combination. The research experience proposed must have the potential to augment the candidate’s research capabilities substantially and provide new research opportunities and benefits that would not be achievable through a collaborative research grant with the mentor(s). The research career enhancement experience should be tailored to the individual needs and level of experience of the candidate. The career enhancement plan may include (1) a didactic academic enrichment plan, e.g., coursework, seminars, journal clubs, etc., and (2) a small-scale research project focused on firearm injury and mortality prevention. The research project is expected to expand the candidate's expertise in conducting firearm injury and mortality prevention research.

Applicants are expected to identify one or more research mentors with relevant expertise in applicant knowledge-gap areas. The mentor(s) must be established, well-qualified, and willing to support the applicant's short-term research career development experience. The candidate and the proposed mentor(s) should not already have established, longstanding collaborations at the time of the application. Candidates are expected to either establish new collaborative arrangements or strengthen and enhance relatively new or developing collaborations on a research project on firearm mortality and injury prevention research.

Examples of novel skill combinations that might result from the mentored training include, but are not limited to:

• For investigators with research expertise in risk factor and/or prevention/intervention work in related or adjacent fields (e.g., substance use, mental health, violence, palliative care), mentored career development experience in firearm injury and mortality prevention research
• For investigators with methodological expertise in relevant approaches (e.g. community engaged research, policy research, implementation science) the opportunity to gain skills and research experience specific to the unique challenges of conducting firearm injury and mortality prevention research
• For investigators with a record of productivity in health disparities or health equity research focused on a particular population who experience a disproportionate burden of firearm violence, the opportunity to gain relevant expertise in conducting firearm injury and mortality prevention research

Scale and Scope of the Research Project

This NOFO is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development.

Accordingly, examples of research projects include, but are not limited to pilot studies in preparation for a full scale R01 clinical trial research project on firearm injury and mortality prevention that will develop, implement and test:

• The ability to identify individuals at risk for firearm injury and mortality (victims and perpetrators), including suicide, homicide, and accidental injury. This may include but is not limited to: a) developing, testing, or validating innovative tools and technologies to screen and/or monitor firearm injury risk and mechanisms; b) applying advanced predictive analytic approaches (e.g., artificial intelligence, computational modeling) in situations for which these approaches can best inform risk identification, and informed by an understanding of the limits of these approaches (e.g., less precision for under-represented groups; data that reflect biases already in systems), and c) developing and testing models addressing the spread of firearm violence (e.g., social contagion).
• Implementation procedures, particularly for healthcare systems (including emergency departments and primary care) to determine who should be screened and how to screen accurately and efficiently for risk of firearm injury and mortality.
• Innovative and culturally competent interventions delivered online, in healthcare, and/or community settings (e.g., schools/childcare, workplaces, justice/legal settings, social service or public health agencies, assisted living facilities) to prevent injury and mortality and revictimization/repeat injury or retaliatory firearm violence among those at risk.
• Hybrid effectiveness-implementation trials designed to test the effectiveness of preventive, intervention, and service interventions while also examining factors or testing strategies to improve implementation or dissemination efforts.
• Interventions that leverage potential protective factors at the individual, family, community and structural levels (and their interactions) that could be enhanced to reduce the negative effects of risk exposure (e.g., resilience).
• Implementation strategies to improve fidelity, adherence, adoption, scale-up and sustainability of existing evidence-based interventions (e.g., safe storage counseling, lethal means counseling, motivational interviewing (e.g., safERteens), community-based violence interrupter programs) to assess barriers at multiple levels (e.g., provider, social, environmental, system, structural or policy).
• Precision health and personalized medicine strategies that can help determine for whom various firearm injury and mortality prevention programs are likely to be most effective.
• The impact of combining public health and criminal justice (crime prevention) approaches to reduce firearm injury and mortality.

The research project should expand the candidate's direct experience with individuals, families, and communities experiencing or at risk for experiencing high levels of firearm injury and mortality and/or with the systems (e.g., healthcare, education, legal/justice) that work to prevent such violence or injury and its impacts over time.

Applicants are strongly encouraged to consider the use of common data elements when feasible and appropriate, including measures outlined in the PhenX Toolkit (www.phenxtoolkit.org).

The structure and budgetary constraints associated with this career enhancement award will limit the scope of the research that can be achieved. Applicants will need to address the feasibility of completing their project within these constraints.

Prospective applicants are strongly encouraged to contact the Scientific Contacts listed for additional guidance about IC-specific priorities in firearm injury and mortality prevention research as outlined in NOT-OD-23-039 Firearm Injury and Mortality Prevention Research.

For NIMH, priorities for research on violence in the context of mental illness are also detailed in NOT-MH-22-095, NIMH Priorities on Research on Aggression and Violence Against Others

Additional Guidance

Research proposed in applications must be ideologically and politically unbiased as defined in the NIH Grants Policy Statement (GPS) sections 4.1.10 and 4.1.17

NIH funds may not be used, in whole or in part, to advocate or promote gun control or to support lobbying activities, as outlined in Section 4 of the NIH GPS.

Applicants to NIMH please note: NIMH support for clinical trials research follows an experimental therapeutics approach, whereby clinical trials are designed, not only to test the intervention effects on outcomes of interest, but also to inform understanding of the intervention’s mechanisms of action. As such, applications that propose to develop and/or test the efficacy/effectiveness of preventive, therapeutic or services interventions must include specification of the intervention target(s)/mechanism(s) and assessment of intervention-induced changes in the presumed target mechanism(s) that are hypothesized to account for the intervention outcome. See the NIMH Guidance for Mentored K Applicants Proposing Clinical Trials, which will apply to NIMH-focused applications submitted for this NOFO .

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

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

Note: This Funding Notice of Opportunity (NOFO) is designed specifically for candidates proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary clinical trial, as part of their research and career development. Those not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO (TEMP 24098).

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Other Award Budget Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

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

• U.S. Territory or Possession

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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

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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM)– 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.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 SAM registration in order to complete the Grants.gov registration.

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

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

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

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 their mentor and organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

Candidates for the K18 award must have a research or health-professional doctoral degree. This award is intended for well-established investigators who have established records of independent, peer-reviewed Federal or private research grant funding. Applicants are not required to have active research grant support at the time of application for this award.

PIs who have been awarded a NIH grant or contract with one or more specific aims related to firearm mortality or injury prevention are not eligible for this funding opportunity.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review. (See NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Individuals are eligible for a K22 award if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or an equivalent non-NIH award. Individuals are NOT eligible to apply if they have a pending application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply if they have been or are currently a PD/PI on an NIH research grant (such as R01, R29, P01, or DP2) or a subproject leader on an NIH multicomponent grant or cooperative agreement (e.g., P01, U19, P20, P30, P50, U54, UM2), or an equivalent NIH or non-NIH award.

At the time of award, the candidate must have a “full-time” appointment at the academic institution. Candidates are required to commit a minimum of 50% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development. Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. 

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-18-156  and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

Mentor(s)

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. Where feasible, the recruitment of women, individuals from diverse racial and ethnic groups, and individuals with disabilities as potential mentors is encouraged, given their ability to serve as role models.

 

The mentor(s) or mentoring team must demonstrate appropriate expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed research and clinical trial.

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, or clinical research.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

SF424(R&R) Senior/Key Person Profile Expanded

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

R&R Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

Candidate
Research Plan
Other Candidate Information
Mentor, Co-Mentor, Consultant, Collaborators
Environment & Institutional
Commitment to the Candidate
Other Research Plan Sections
Appendix

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

Candidate Section

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

Candidate Information and Goals for Career Development

Candidate’s Background

• Describe the candidate's commitment to a career as a health related research scientist. 
• Describe the candidate's research efforts and accomplishments in health related research to date as an independent investigator, including publications, prior research interests and experience, and history of research support. 
• Present evidence of the candidate's potential to augment their research career and to ultimately advance scientific progress through this career enhancement plan. 
• Provide evidence of the candidate's ability to interact and collaborate with other scientists, particularly those from other disciplines.

• If applicable, describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial.
• If applicable, describe the candidate's prior efforts, interests and experience in clinical trials research.

Career Goals and Objectives​

• Describe the candidate's research career trajectory to date and future career goals and objectives and explain how these relate to the proposed research career development enhancement program. 
• Justify the need for further career enhancement in order to achieve the candidate's future research goals. 
• Demonstrate how the proposed career enhancement program and the research, educational and mentoring resources of the sponsoring laboratory and institution will further the stated research career goals.

• The candidate must demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

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

• The candidate and the mentor are jointly responsible for the preparation of the career development plan. The candidate and mentor may propose a mentoring team. 
• Describe the career development plan, tailoring it to the candidate's goals, prior experience and career level, as well as to the intent of the K18 program. 
• Provide a systematic plan for progression of career enhancement and research experiences for the period of the award and beyond, including a timeline for the phasing of the career enhancement and research activities. 
• Explain how the career development plan will enhance the candidate’s independent research career trajectory, including a description of any cutting-edge research skills and conceptual knowledge that will be acquired during the career award period.
• Describe any clinical, administrative, teaching, mentoring or grant-related research commitments the applicant will maintain during the period of the award, and the arrangements to be made with the applicant institution and/or the host institution to ensure the requisite protected time for this award period.

Research Plan Section

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

Research Strategy

• A sound research project that is consistent with the candidate’s level of research development and objectives of their career development plan must be provided. The research description should demonstrate the quality of the candidate’s research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out the research.
• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan.
• Although it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored career development plan.

• Describe the proposed timelines for the proposed clinical trial, feasibility study or ancillary clinical trial, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).
• Describe how the proposed clinical trial or ancillary clinical trial will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study).

Training in the Responsible Conduct of Research

• All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

Plans and Statements of Mentor and Co-mentor(s)

• The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program.  The candidate may also nominate co-mentors as appropriate to the goals of the program.  
• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award. 
• Include a statement that the candidate will commit at least 6 person months (50% of full-time professional effort) to the career development program and related career development activities. 
• The application must include a statement from the mentor providing: 1) information on their research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; 3) a plan for career progression for the candidate to move from the mentored stage of their career to independent research investigator status during the project period of the award; and 4) a plan for monitoring the candidate’s research, publications, and progression towards independence. 
• Similar information must be provided by any co-mentor.  If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be described.  Co-mentors should clearly describe how they will coordinate the mentoring of the candidate. If any co-mentor is not located at the sponsoring institution, a statement should be provided describing the mechanism(s) and frequency of communication with the candidate, including the frequency of face-to-face meetings. 
• The primary mentor must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

• The mentor or mentoring team must provide evidence of expertise, experience, and ability to guide the candidate in the organization, management and implementation of the proposed clinical trial, ancillary clinical trial or feasibility study and help him/her to meet timelines.

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Unless also listed as senior/key personnel, collaborators and consultants do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. 
• Advisory committee members (if applicable): Signed statements must be provided by each member of the proposed advisory committee.  These statements should confirm their participation, describe their specific roles, and document the expertise they will contribute.  Unless also listed as senior/key personnel, these individuals do not need to provide their biographical sketches. 

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate. 
• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan.
• Describe the resources and facilities that will be available to the candidate. 

• Describe the resources and facilities that will be available to the candidate, including any clinical trial-related resources, such as specialized administrative, data coordinating, enrollment, and laboratory/testing support. If applicable, include a description of the resources and facilities available at international sites.

Institutional Commitment to the Candidate’s Research Career Development

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. 
• Provide assurances that the candidate will be able to devote the required effort to activities under this award. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist. 
• Provide assurances that the candidate will have access to appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations, as applicable) to carry out the proposed research plan. 
• Provide assurance that appropriate time and support will be available for any proposed mentor(s) and/or other staff consistent with the career development plan.

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 application forms packages.

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

• 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

Appendix:

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

PHS Assignment Request Form

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

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov. 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and Times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost .

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

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 fieldof the Senior/Key Person Profile form. 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 NOFO for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

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.

The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the possibility that research support provided through career development awards may be sufficient to support only small feasibility studies.

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, 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.

Appeals for initial peer review will not be accepted for applications submitted in response to this NOFO.

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website. 

HHS recognizes that NIH 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 NOFO.

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 the Federal 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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

3. Data Management and Sharing

Consistent with the 2023 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.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

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

Section VII. Agency Contacts

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

Because of the difference in individual Institute and Center (IC) program requirements for this NOFO, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

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: https://www.era.nih.gov/need-help (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]

The Office of Behavioral and Social Sciences (OBSSR) does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs listed below for inquiries regarding the suitability of the proposed project for the NOFO and the IC's research portfolio

Dara Blachman-Demner, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-8522
Email: [email protected]

Belinda Sims, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email:  [email protected]

Valerie Maholmes, PhD, CAS
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1514
Email: [email protected]

Carrie Fried Mulford
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-827-6473
E-mail: [email protected]

Sung Sug (Sarah) Yoon, RN, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: [email protected]

Melissa Gerald, Ph.D.
National Institute on Aging (NIA)
Phone: 301-402-4156
E-mail: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: [email protected]

Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email: [email protected]

Crystal Barksdale, PhD, MPH
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-402-1366
E-mail: [email protected]

Lanay M. Mudd, Ph.D., FACSM
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-9346
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

x

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: [email protected]

Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
E-mail: [email protected]

Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

Section VIII. Other Information

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

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

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 2 CFR Part 200.