The National Institutes of Health (NIH) is dedicated to fostering a robust and diverse pool of talented scientists to address the nation’s evolving biomedical, behavioral, and clinical research needs. A cornerstone of this commitment is the support of comprehensive career development programs designed to nurture the next generation of researchers. Among these initiatives, the Women’s Reproductive Health Research (WRHR) Career Development Program (K12) stands out as a vital pathway for clinicians aiming to specialize in women’s health research. This guide provides an in-depth look at the NIH WRHR K12 Trainee Career Development Program, offering essential information for institutions and aspiring physician-scientists interested in participating.
Understanding the NIH WRHR K12 Career Development Program
The WRHR K12 program, spearheaded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), is a nationwide network of mentored institutional career development programs. Its central mission is to cultivate junior faculty, particularly those recently completing postgraduate clinical training in obstetrics and gynecology (OB/GYN), into independent researchers focused on women’s reproductive health. The overarching goal is to strengthen the national capacity of outstanding clinician-investigators who will not only advance the field of OB/GYN but also significantly contribute to improving women’s health outcomes.
This initiative addresses a critical need for highly skilled clinician-scientists capable of tackling the complex challenges and opportunities within women’s reproductive health research. By providing state-of-the-art, multidisciplinary research training, the WRHR program empowers its scholars to become leaders in their field, capable of conducting impactful research and mentoring future generations of scientists.
Participating Organizations: NIH & NICHD
The primary participating organization is the National Institutes of Health (NIH), with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) taking the lead in administering this funding opportunity. It’s important to note that while applications should align with the missions of the Institutes/Centers involved, the NIH Office of Research on Women’s Health (ORWH) may also co-fund applications assigned to participating Institutes/Centers, highlighting the NIH-wide commitment to women’s health research.
Activity Code: K12 Physician Scientist Award (PSA)
The WRHR program utilizes the K12 activity code, specifically the Physician Scientist Award Program (PSA). The K12 mechanism is designed for institutional career development awards, indicating that funding is granted to institutions to develop and implement comprehensive programs, rather than directly to individual trainees. This institutional approach allows for a structured and supportive environment for career development, benefiting multiple scholars within a cohesive program framework. The Physician Scientist Award designation emphasizes the program’s focus on training individuals with clinical doctorates (MD or DO) to become independent researchers.
Funding Opportunity Number & Title
This specific funding opportunity is identified by the Funding Opportunity Number (FON) RFA-HD-25-005, a reissue of RFA-HD-20-013. The official Funding Opportunity Title is: Women’s Reproductive Health Research (WRHR) Career Development Program (K12 Clinical Trial Optional). This title clearly articulates the program’s focus, target area (women’s reproductive health), the funding mechanism (K12), and the optional inclusion of clinical trials in the proposed research and training plans.
Key Dates and Deadlines
Understanding the key dates is crucial for potential applicants. Here’s a breakdown of the timeline for this funding opportunity:
| Date Type | Date |
|---|---|
| Posted Date | July 19, 2024 |
| Open Date (Earliest Submission Date) | October 15, 2024 |
| Letter of Intent Due Date(s) | October 15, 2024 |
| Application Due Dates | November 15, 2024 |
| Scientific Merit Review | March 2025 |
| Advisory Council Review | May 2025 |
| Earliest Start Date | July 2025 |
| Expiration Date | November 16, 2024 |
Important Notes on Deadlines:
- All applications are due by 5:00 PM local time of the applicant organization on the Application Due Date.
- Applicants are strongly encouraged to submit early to allow ample time to correct any errors encountered during the submission process.
- No late applications will be accepted.
It’s vital for institutions planning to apply to adhere strictly to these deadlines and begin the application process well in advance to ensure a smooth and successful submission.
Who Can Apply? Eligibility and Requirements
The NIH WRHR K12 program has specific eligibility criteria for both applicant organizations and the individuals involved in the program, including Program Directors/Principal Investigators (PD/PIs), mentors, and scholars (trainees).
Eligible Organizations
A range of organizations are eligible to apply for the WRHR K12 program, reflecting the NIH’s commitment to broad institutional participation. Eligible applicant organizations include:
Higher Education Institutions:
- Public/State Controlled Institutions of Higher Education
- 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
- Nonprofits without 501(c)(3) IRS Status
Local Governments:
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- U.S. Territory or Possession
Other Eligible Entities:
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
The sponsoring institution must demonstrate a strong commitment to the proposed program, including providing adequate staff, facilities, and educational resources to support its goals. Applications are typically submitted by Departments of Obstetrics and Gynecology or similar departments within larger medical institutions or women’s hospitals.
Applicant Institution Requirements
To be competitive, applicant institutions must demonstrate several key characteristics:
- Strong OB/GYN Department: The department must have a primary teaching site within a hospital for women or a larger medical institution.
- Established Research Investigators: A substantial pool of highly trained, established investigators with active research programs related to OB/GYN and its subspecialties is essential.
- Clinical and Research Facilities: Institutions must possess the necessary clinical specialties, subspecialties, and research facilities to support basic, translational, and/or clinical research in women’s reproductive health.
- Commitment to Career Development: A demonstrated commitment and capability to provide career development guidance to promising candidates aspiring to become independent investigators is crucial.
- High-Quality Research Program: The institution must have a robust, high-quality research program in the proposed area, with faculty, staff, potential scholars, and facilities to conduct the program effectively.
PD/PI Eligibility
The Program Director/Principal Investigator (PD/PI) is pivotal to the success of the WRHR K12 program. Eligible PD/PIs must:
- Possess the skills, knowledge, and resources to direct the proposed research training program.
- Be an established investigator in the relevant scientific area.
- Be capable of providing both administrative and scientific leadership.
- Be responsible for trainee selection, program direction, management, administration, and evaluation.
- Monitor program progress and submit required reports.
- Make final decisions regarding program fund allocation.
Institutions may propose multiple PD/PIs if a multiple leadership approach strengthens the program. A separate Research Director can be designated for day-to-day administration, but the PD/PI retains ultimate responsibility.
Scholar Eligibility
Scholars, the trainees within the WRHR K12 program, must meet specific criteria at the time of appointment:
- Physician Degree: Hold an MD or DO degree.
- OB/GYN Residency Completion: Have completed postgraduate residency training in obstetrics and gynecology.
- Mentor Identification: Have identified an approved mentor or mentors with extensive research experience.
- Research Effort Commitment: Be able to dedicate at least 9 person-months (75%) of full-time professional effort to research and career development activities. Surgeon-scientists may devote a minimum of 6 person-months (50%) under specific conditions.
- Effort Duration: Commit to the specified effort level (75% or 50%) for a minimum of two consecutive years (or three for surgeon-scientists at 50% effort).
- Prior Funding Restrictions: Not be or have been a PI on significant NIH grants (R01, R29, U01/U10, P01 subproject, P50/P60/U54 Center grant, or individual mentored/non-mentored career development awards like K01, K02, K08, K22, K23, K24, K25, K99). Prior R03 or R21 grants may be permissible.
- Citizenship: Be a U.S. citizen, noncitizen national, or lawfully admitted for permanent residence.
Scholars are considered junior faculty appointments, not fellowships, and may be general OB/GYNs (not intending to pursue further fellowships). Appointments can occur in the final year of subspecialty fellowship if designated as a primary research year.
Mentor Eligibility
Mentors are crucial for guiding WRHR Scholars. Eligible mentors must:
- Have strong research records, including recent publications and successful grant funding.
- Have a history of successful research training, with former trainees in productive careers.
- Be independent investigators actively involved in basic, translational, and/or clinical research relevant to the WRHR program.
- Hold senior faculty positions.
- Be supported by NIH or other competitively awarded grants.
- Be recognized experts in applying new advances in relevant research areas.
- Be committed to providing expertise, guidance, and laboratory facilities to Scholars.
- Have a successful record of research training and commit to close interaction with Scholars throughout their program duration.
While mentors can be from outside the OB/GYN department, the Scholar’s research project should primarily relate to OB/GYN and its subspecialties.
Ineligible Entities
Foreign organizations (non-domestic, non-U.S. entities) and non-domestic components of U.S. organizations are not eligible to apply for WRHR K12 awards. However, foreign components within U.S. organizations are permitted, allowing for potential international research collaborations for scholars.
Funding Details and Award Information
Understanding the financial aspects of the WRHR K12 program is essential for institutions preparing applications.
Funding Instrument: Grant
The WRHR K12 program utilizes a grant mechanism. Grants are financial assistance vehicles providing funds to eligible entities to carry out approved projects. This signifies a collaborative partnership between the NIH and the grantee institution to achieve the program’s objectives.
Clinical Trial Option
The WRHR K12 program is clinical trial optional. This means institutions can submit applications proposing programs with or without clinical trial components. Scholars can be appointed to:
- Lead an independent clinical trial.
- Propose a separate ancillary clinical trial.
- Gain research experience within a clinical trial led by another investigator.
This flexibility allows institutions to tailor their programs to their strengths and the research interests of their faculty and potential scholars.
Funds Available and Award Amounts
The NICHD and partner components anticipate committing a total of $4,800,000 in FY 2025 to fund approximately 14-17 awards. While this provides an estimate, the actual number of awards may vary depending on application quality and available funds.
Applicants can request direct cost budgets of up to $315,000 per year. The maximum project period is 5 years. These figures set the boundaries for program budgets and project duration.
Scholar Costs Breakdown
A significant portion of the WRHR K12 award is dedicated to supporting the Scholars. The program is designed to support an average of two scholars per year, with the NICHD providing up to $125,000 in direct costs per year for each scholar. This scholar cost allowance is further divided into:
- Salary and Fringe Benefits: Up to $100,000 per year. Salary levels must align with institutional policies for similar positions and cannot exceed the congressionally mandated cap. Scholars must dedicate a minimum of 9 person-months (75%) of full-time professional effort to research and career development (or 6 person-months/50% for surgeon-scientists under specific conditions). Institutional salary supplementation is allowed but not from federal funds unless explicitly authorized.
- Research and Career Development Support: Up to $25,000 per year. This category covers essential expenses such as:
- Research supplies and equipment.
- Partial salary support for technical assistants.
- Travel to training or scientific meetings (up to $3,500 annually for presenting WRHR-funded work).
- Tuition, fees, and books.
- Computer services.
These scholar costs must be itemized and justified in the budget, directly related to the scholar’s research and career development activities.
Other Allowable Program Costs
Beyond scholar costs, the WRHR K12 award can support other program-related expenses, with a combined annual direct cost limit of $65,000 for personnel costs (excluding scholars) and these other program-related expenses. Allowable costs include:
- Personnel Costs: Salary and fringe benefits for individuals designing, directing, and implementing the program (e.g., PD/PI, Research Director, Recruiting Officer, Program Assistant), justified by their person-months devoted to the program. Salary for the Research Director can be requested for up to 1.2 person-months effort (or combined 1.2 person-months if PD/PI also serves as Research Director, or up to 2.4 person-months if Research Director also serves as Recruiting Officer).
- Consultant costs, equipment, supplies, and travel for key persons.
- Minimal advertising and recruitment costs.
- Administrative support services directly associated with the WRHR program (supplies, duplicating equipment, telephones, maintenance contracts).
- Travel for Scholars, PD/PI, and Research Director to the annual WRHR Program meeting and for Scholars to one additional training or scientific meeting per year.
These costs must be justified as essential for the proposed program and not duplicate resources already available at the institution.
Unallowable Costs
Certain costs are not supported by WRHR K12 funds:
- Patient care costs (inpatient bed days, outpatient visits), except for clinical laboratory analyses essential for Scholar research.
- Facility alterations and renovations.
- Salaries and fringe benefits for the PD/PI or program mentors (unless PD/PI also serves as Research Director, as noted above).
- Direct support of mentor laboratories beyond expenses directly attributable to Scholar projects.
- Salaries and support for central institutional administrative personnel (budget officers, grant assistants, building maintenance).
- Salaries and support for institutional public relations or health/educational services.
- Travel of PD/PI, Research Director, or mentors to scientific meetings beyond those related to WRHR program administration.
Indirect Costs
Indirect Costs (Facilities & Administrative [F&A] Costs) are reimbursed at a fixed rate of 8% of modified total direct costs. This modified total excludes tuition and fees, consortium costs exceeding $25,000, and equipment expenditures. This reduced indirect cost rate is typical for training-related grants.
Application Process: A Step-by-Step Guide
Applying for the WRHR K12 program requires careful preparation and adherence to NIH guidelines. Here’s a step-by-step guide to navigate the application process.
Letter of Intent (Optional)
While not required or binding, submitting a Letter of Intent (LOI) is encouraged. The LOI helps NICHD staff estimate the review workload and plan the review process. The LOI should be submitted by the Letter of Intent Due Date (October 15, 2024) and include:
- Descriptive title of the proposed activity.
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s).
- Names of other key personnel.
- Participating institution(s).
- Funding Opportunity Number (RFA-HD-25-005) and Title.
The LOI should be sent to the designated NICHD contact (Donna Mazloomdoost, MD).
Required Registrations
Applicant organizations and PD/PIs must complete several registrations to be eligible to apply and receive an award. These registrations can take time, so initiating them early is crucial:
Applicant Organizations must register with:
- System for Award Management (SAM): https://www.sam.gov/
- Grants.gov: https://www.grants.gov/
- eRA Commons: https://public.era.nih.gov/commons/public/begin/beginPublic.do
Program Directors/Principal Investigators (PD/PIs) must have an eRA Commons account:
- PD/PIs should affiliate their eRA Commons account with the applicant organization.
- If the PD/PI is also the organizational Signing Official, they need two distinct eRA Commons accounts.
Complete registration details are available in the NIH How to Apply – Application Guide. Failure to register on time is not a valid reason for late submission.
Application Package Access
The application forms package for RFA-HD-25-005 must be accessed through:
- ASSIST: https://public.era.nih.gov/assist/public/welcome.do
- Grants.gov Workspace: https://www.grants.gov/web/grants/applicants/workspace-overview.html
- Institutional System-to-System (S2S) solutions: Check with your institution’s administrative office for S2S instructions.
Links to ASSIST and Grants.gov Workspace are provided in Part 1 of the NOFO.
Content and Form of Submission
Applications must adhere strictly to the Training (T) Instructions in the NIH How to Apply – Application Guide, as well as specific instructions in the NOFO. Key forms and attachments include:
- SF424(R&R) Cover Page: Standard application face page.
- SF424(R&R) Project/Performance Site Locations: Details of where the program will be conducted.
- SF424 (R&R) Other Project Information: Includes information about foreign components (if any) and the Project Summary/Abstract.
- SF424(R&R) Senior/Key Person Profile Expanded: Information on PD/PIs and key personnel.
- PHS 398 Cover Page Supplement: Additional cover page information.
- PHS 398 Training Subaward Budget Attachment(s): Budget details for any subawards.
- Research and Related (R&R) Budget: Comprehensive budget for the program.
- PHS 398 Research Training Program Plan: The core of the application, detailing the program plan, faculty, scholars, evaluation, and recruitment plan. This includes required Training Data Tables.
- PHS Human Subjects and Clinical Trials Information: If applicable, information on human subjects research and clinical trials.
- PHS Assignment Request Form: Optional form for assignment preferences.
- Other Attachments: Including an Advisory Committee plan (highly recommended).
Important Considerations:
- Use the term “scholars” instead of “trainees” and “career development” instead of “training” throughout the application.
- For applications involving foreign components, a Foreign Justification attachment is required.
- The Project Summary/Abstract should be comprehensive, outlining program objectives, rationale, design, key activities, scholar levels, and intended outcomes.
- An Advisory Committee plan, if included, should detail committee composition, roles, responsibilities, expertise, meeting frequency, and evaluation methods.
Page Limitations and Formatting
All page limitations specified in the How to Apply – Application Guide and the Table of Page Limits must be followed. Adhering to formatting guidelines (font size, margins, etc.) is also crucial for readability and review.
Submission Dates and Deadlines
Applications must be submitted electronically through Grants.gov by the Application Due Date (November 15, 2024) and time (5:00 PM local time of applicant organization). Early submission is strongly advised. Applicants must track their application status in eRA Commons to ensure successful submission and address any errors.
Intergovernmental Review (Not Applicable)
The WRHR K12 program is not subject to intergovernmental review under Executive Order 12372.
Funding Restrictions
All NIH awards are subject to standard NIH funding restrictions and terms and conditions outlined in the NIH Grants Policy Statement. Pre-award costs are generally allowable only under specific circumstances, excluding stipends or tuition/fees for trainees before appointment.
Unique Entity Identifier and SAM
Applicant organizations must ensure they have a Unique Entity Identifier (UEI) and maintain active registrations in SAM.gov, eRA Commons, and Grants.gov. The UEI provided in the application must match the identifier in the organization’s eRA Commons profile and SAM.gov.
Review Process and Criteria
NIH applications undergo a rigorous peer review process to assess their scientific and technical merit. Understanding the review criteria is essential for preparing a competitive application.
Peer Review Process
Applications are reviewed by Scientific Review Groups convened by the NICHD, following NIH peer review policies. Each application receives a written critique. A selection process may occur where only the highest-merit applications are discussed and scored. Appeals of initial peer review decisions are not permitted for this NOFO.
Overall Impact Score
Reviewers provide an overall impact score reflecting their assessment of the likelihood that the proposed program will effectively prepare individuals for successful research careers and significantly influence the relevant research field. This score is based on the scored review criteria and additional review criteria.
Scored Review Criteria
Reviewers evaluate applications based on the following scored criteria, assigning a separate score for each:
- Significance: Does the program address an important need? Will it develop well-qualified junior investigators? Is there evidence of a sufficient pool of potential scholars?
- Approach: Are the program’s didactic, career development, and research activities appropriate in content and duration? Does the program foster skills in rigorous and reproducible research? Are timelines for career progression and independence appropriate?
- Environment: Does the institutional environment (facilities, resources) contribute to program success? Does the program leverage unique features of the environment or collaborations? Is institutional commitment adequate? Is multi-site participation justified? Is there sufficient assurance of effort from PD/PI, mentors, and scholars? Is the Advisory Committee plan adequate (if applicable)?
- For Clinical Trial Applications: Are administrative, data coordinating, enrollment, and laboratory/testing centers appropriate? Is the ability to conduct trials at proposed sites adequate? Are plans for multi-site coordination and international sites (if any) well-addressed?
- Leadership (PD/PI and Mentors): Do PD/PI(s) have the expertise, experience, and ability to oversee the program and clinical trials (if applicable)? Is the leadership team qualified and committed? Are mentor qualifications, stature, experience, and mentoring track records appropriate? Are PD/PI(s) and mentors actively engaged in relevant research?
- For Multiple PD/PI Applications: Is the multiple PD/PI approach justified? Is there a strong and compelling leadership approach with clear roles and responsibilities?
- For Clinical Trial Mentor Applications: Do mentors have expertise in clinical trial organization, management, and implementation?
- Scholars: Is the recruitment plan likely to attract high-quality scholars? Are recruitment and selection strategies well-defined and justified? Is there evidence of a large enough scholar pool? Is the career development plan appropriate for achieving scholar independence?
- For Clinical Trial Scholar Applications: Do prospective scholars have the potential to manage clinical trials? Are there plans for data management and statistics instruction relevant to clinical trials?
- Evaluation and Past Training Record: Is there evidence of successful past training records for PD/PI and mentors? Does the program have a rigorous evaluation plan?
Additional Review Criteria
Reviewers also consider the following additional criteria, but do not assign separate scores:
- Training in Enhancing Reproducibility: Does the program adequately address training in scientific reasoning, rigorous research design, experimental methods, biological variables, authentication of resources, quantitative approaches, and data analysis?
- For Renewal Applications: Reviewers assess progress in the last funding period, including diversity recruitment and RCR training. Are program accomplishments described? Are improvements proposed? Is there evidence of past training success?
Additional Review Considerations
Reviewers consider these aspects without scoring, and they do not factor into the overall impact score:
- Recruitment Plan to Enhance Diversity: Evaluated separately as Acceptable or Unacceptable based on strategies to recruit underrepresented groups.
- Plan for Instruction in the Responsible Conduct of Research (RCR): Evaluated as Acceptable or Unacceptable based on format, subject matter, faculty participation, duration, and frequency of RCR instruction. Renewal applications are assessed on past RCR instruction and proposed improvements.
- Select Agent Research: If applicable, reviewers assess the use, registration, monitoring, biosafety, biocontainment, and security plans for Select Agents.
Funding Decisions
Funding decisions are based on:
- Scientific and technical merit as determined by peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
Award Administration and Reporting
Successful applicants will receive a Notice of Award and must adhere to specific administrative and reporting requirements.
Award Notices
A Notice of Award (NoA) is the official notification of funding, sent to the recipient institution’s business official. The NoA outlines the terms and conditions of the award. By accepting the award, the institution agrees to comply with all applicable regulations and policies.
ClinicalTrials.gov Registration
If the award involves clinical trials, registration and results reporting on ClinicalTrials.gov are legally required for “applicable clinical trials” and expected for all trials, regardless of legal obligation.
IRB/IEC Approval
Recipient institutions must ensure IRB or Independent Ethics Committee (IEC) review and approval for all protocols involving human subjects research. NIH requires copies of documents related to major changes in ongoing protocols.
Data and Safety Monitoring
NIH policy mandates data and safety monitoring for all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to protect participant safety and data integrity.
Data Management and Sharing
Consistent with the NIH Data Management and Sharing Policy, recipients are required to adhere to data management and sharing requirements as outlined in the NIH Grants Policy Statement when data management and sharing is applicable to the award.
Reporting Requirements
Recipients must submit annual Research Performance Progress Reports (RPPRs) and financial statements as required by the NIH Grants Policy Statement. Continuation funding depends on timely and acceptable submission of these reports. A final RPPR, invention statement, and expenditure data are required for award closeout. Evaluation results should be included in the final RPPR.
Evaluation
The NIH may request information to evaluate program effectiveness from databases and program participants. Participants may be contacted for updates on their career history, publications, grants, awards, and professional activities to assess the program’s long-term impact.
Agency Contacts and Further Information
For inquiries regarding this funding opportunity, potential applicants are encouraged to contact the relevant NIH staff.
Application Submission Contacts
- eRA Service Desk: For ASSIST, eRA Commons, application errors, system issues: https://www.era.nih.gov/need-help, 301-402-7469 or 866-504-9552.
- General Grants Information: For application processes and NIH grant resources: [email protected], 301-480-7075.
- Grants.gov Customer Support: For Grants.gov registration and Workspace: 800-518-4726, [email protected].
Scientific/Research Contacts
- Donna Mazloomdoost, MD (NICHD): 301-594-1336, [email protected].
- Elena K Gorodetsky, M.D., Ph.D. (ORWH): (301) 594-9004, [email protected].
Peer Review Contact
- Joanna Kubler-Kielb, PhD (NICHD): 301-435-6916, [email protected].
Financial/Grants Management Contact
- Yvonne Talley (NICHD): 301-496-7432, [email protected].
Conclusion
The NIH WRHR K12 Trainee Career Development Program represents a significant investment in the future of women’s reproductive health research. By providing comprehensive support and mentorship to junior faculty in obstetrics and gynecology, this program is crucial for building a strong and capable workforce dedicated to improving women’s health. Institutions with a commitment to women’s health research and a strong OB/GYN department are encouraged to consider applying for this valuable funding opportunity to further develop their trainee career development program and contribute to this vital field.
