Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including the Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The overall goal of the NIH Research Career Development programs 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. More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

This funding opportunity announcement (FOA) invites applications to continue to support a national program of mentored institutional career development programs for junior faculty who have recently completed postgraduate clinical training in obstetrics and gynecology, and are committed to an independent research career in women's reproductive health. The supervised research training will assist junior faculty in their transition into productive, physician scientists in areas related to obstetrics and gynecology and its subspecialties.

The goal of this FOA is to build a national capacity of junior investigators in women's reproductive health research, provide junior faculty with state of the art training in women’s reproductive health research in an academic setting, stimulate women’s reproductive health research over a variety of disciplines, and secure an outstanding research experience for junior faculty leading to a career as a successful independent investigator.

The goal of the Women’s Reproductive Health Research (WRHR) Career Development Program is to promote the performance of research and transfer of findings that will benefit the health of women. This will be accomplished by supporting the research career development of obstetrician-gynecologists (referred to as "WRHR Scholars"). These K12 Program grant awards will ultimately result in a well-qualified cadre of academic obstetrician-gynecologist investigators who will help strengthen the research capacity in health professional institutions and meet the need for highly skilled scientists with a clinical background who can address the increasing research opportunities in women's reproductive health.

The proposed institutional research career development program may complement other, ongoing research training and career development programs at the applicant institution, but the proposed career development experiences must be distinct from those career development programs currently receiving Federal support.

The WRHR Program was initiated by NICHD in 1998 in response to concerns about the need for greater numbers of physician scientists in women's reproductive health research. The WRHR Program supports research career development of obstetrician-gynecologists who have recently completed postgraduate clinical training, and who are commencing basic, translational and/or clinical research relevant to the field of obstetrics and gynecology (ob/gyn). Senior investigators with established research programs covering a broad range of basic and applied biomedical and biobehavioral science related to obstetrics and gynecology, together with collaborating departments, form the intellectual and technical base for mentoring junior faculty accepted into the program. Although mentors from collaborating departments may provide needed expertise and resources, the emphasis of the WRHR Scholars' scientific projects should be on research ultimately relevant to obstetrics and gynecology, and/or its subspecialties. This funding opportunity is intended to address the need for multidisciplinary career development and training at the postdoctoral level and provide a transition to independence. There is expectation that the K12 Programs established in response to this announcement will become national incubator environments for development of independent researchers able to sustain viable careers and mentor those that follow them.

The overall objective of the WRHR Program is to bridge clinical training with research independence through a mentored research experience leading to an independent scientific career addressing women's reproductive health concerns. This FOA represents a continued expansion of ongoing research efforts to generate numbers of ob/gyn physician scientists who would be able to obtain independent support to conduct research in women’s reproductive health.

The research scope for applicants encompasses all areas of ob/gyn and its related subspecialties: maternal-fetal medicine, gynecologic oncology, reproductive endocrinology and infertility, and female pelvic medicine and reconstructive surgery, as well as relevant fields such as adolescent gynecology and the reproductive health of women with disabilities. Projects may be basic science, translational, and/or clinical research, but must be within the biomedical and biobehavioral purview of the NIH. Research with a primary focus on health care delivery, health care services, or health policy is outside the scope of this FOA. Programs focused on somatic health, for example, breast, cardiovascular or musculoskeletal systems, should similarly not be proposed.

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

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)

Governments

• Indian/Native American Tribal Governments (Federally Recognized)

• Indian/Native American Tribal Governments (Other than Federally Recognized)

• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)

• Faith-based or Community-based Organizations

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

An application may be submitted on behalf of a Department of Obstetrics and Gynecology (here understood to include a department providing obstetrical and/or gynecologic care as its primary function, regardless of title) that has as a primary teaching site either a hospital for women or an obstetrics-gynecology program with an identifiable organizational structure within a larger medical institution. The applicant institution must have an adequate pool of highly trained established investigators in research related to obstetrics and gynecology and its related subspecialty areas. Applicant institutions must have the clinical specialties and subspecialties and the clinical and research facilities sufficient to meet the purposes of the WRHR Program, namely, to bridge clinical training with a career in basic, translational and/or clinical research relevant to women's reproductive health. These institutions should also have the commitment and capability to provide career development guidance to promising candidates who aspire to become independent investigators.

The applicant institution must have a strong and high quality research program in the area(s) proposed under this FOA and must have the requisite faculty and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating scholars may gain relevant experiences consistent with their research interests and goals.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

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

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

• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

Program Director/Principal Investigator (PD/PI) - The PD/PI must be the Chair of the Department of Obstetrics and Gynecology or equivalent. When multiple PDs/PIs are involved, at least one must be the Chair the Department of Obstetrics and Gynecology or equivalent. The PD(s)/PI(s) should possess the educational and scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary research and career development program of this scope. The PD(s)/PI(s) must be capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD(s)/PI)(s) make the final decisions regarding appropriate recipients of the program funds for research and career development, taking into consideration recommendations from the WRHR Advisory Committee.

Research Director - The Research Director must be an established investigator and have experience and qualifications complementing those of the PD/PI. He or she will be responsible for some or all of the day-to-day operations of the WRHR Program. The Research Director should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a program for developing junior investigators. If appropriate, a PD/PI may serve a dual role as both PD/PI and the Research Director. The Research Director should have a record of accomplishment in mentoring successful investigators.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is programmatically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;

Of an investigator-initiated application that was originally submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Mentors should be recognized as independent investigators who are actively involved in basic, translational, and/or clinical research relevant to this initiative, and who have a successful record of providing research training of a type expected in this Program. The mentors should hold senior faculty positions, be supported by NIH or other competitively awarded grants, and be acknowledged experts in the application of new advances in basic science, translational or clinical research. Mentors are not required to be members of the Department of Obstetrics and Gynecology. Although mentors from collaborating departments may provide needed expertise and resources, the emphasis of the WRHR Scholars' scientific projects should be on research relevant to ob/gyn and its subspecialties..

Candidates for appointment to the K12 program are junior faculty who have recently completed postgraduate clinical training in obstetrics and gynecology, and are committed to launching an independent research career in women's reproductive health.
Scholars to be supported by the institutional career development program must be at the career level for which the planned program is intended. Scholars are expected to devote a minimum of 9 person-months (75% of full-time professional effort) during the appointment on the K12 award.

Details on citizenship requirements are available in the NIH Grants Policy Statement.

An institution receiving a WRHR Program award must recruit and select Scholars who have the potential to develop into independent investigators. At the time of appointment to the K12 Program, candidates for WRHR Scholars must:

• Be a physician holding the M.D. or D.O. degree;

• Have completed postgraduate residency training in obstetrics and gynecology;

• Identify an approved mentor or mentors with extensive research experience;

• Be able to devote at least 9 person months (equivalent to 75 percent) of full-time professional effort conducting research and research career development;

• Not be or have been a PD/PI on an R01, R29, U01/U10, subproject of a Program Project (P01), Center (P50, P60, U54) grant, or individual mentored or non-mentored career development award (e.g., K01, K02, K08, K22, K23, K24, K25, K99). Individuals who are or were PIs on NIH Small Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s) may be eligible providing they meet the other eligibility requirements.

The Scholar position is a junior faculty appointment. However, scholars may be appointed to the K12 program in the final research year of subspecialty fellowship training. That year would be counted as the initial part of the K12 experience, not an additional year in the K12 program.

Scholar candidates cannot have had more than 6 years of research training experience beyond their last doctoral degree. Some individuals who are interested in the K12 program may have had a career hiatus because of family responsibilities, uniformed service, or other circumstances. For such individuals, there is no limit on time elapsed since completion of training.

WRHR Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. Scholars are encouraged to apply for independent research grant support during the period of K12 support, and are allowed concurrent salary support only while in the last two years when in compliance with NIH Policy Notice, NOT-OD-08-065.

Combined support through the K12 and other NICHD mentored career development award programs must not exceed six years. Scholars should contact NICHD staff if there are questions regarding eligibility.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity

• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)

• Names of other key personnel

• Participating institution(s)

• Number and title of this funding opportunity

The letter of intent should be sent to:

Estella Parrott, MD, MPH
Gynecologic Health and Disease Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6971
Email: [email protected]

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA), with the following additional modifications:

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research career development program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of scholars including their levels (i.e., , fellows, faculty), and intended scholar outcomes.

Other Attachments. A plan must be provided for the appointment of an Advisory Committee. The Advisory Committee will be a group of scientists from the sponsoring department and other departments or institutions, as appropriate, with research interests relevant to the WRHR Program. The major functions of the committee are to evaluate: 1) applications from potential Scholar candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations to the PD/PI concerning scholar appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the scholars' research experience), and makes recommendations regarding their continuation. The committee may use institutional or outside consultants, if needed.

Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies, the recruitment and retention of candidates, and the evaluation of the overall effectiveness of the program. The composition of the Advisory Committee, identifying the roles, responsibilities and the desired expertise of members, frequency of committee meetings, and other relevant information should be included. Note that proposed Advisory Committee members should not be named in the application. Renewal applications with Advisory Committees should include names of existing external advisors. Please name your file Advisory_Committee.pdf .

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA).

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Include all personnel other than the Training PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff. Also include proposed salary costs for planned scholars.

• Do not complete the section on Participant/Trainee Support Costs.

All Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application must be followed, with the following additional instructions:

Substitute the term scholars for all references to trainees in the SF424 (R&R) Application Guide, and substitute the term career development for all references to training in the SF424 (R&R) Application Guide.

Program Plan

Program Administration. Describe the acknowledged strengths, leadership and administrative skills, training experience, scientific expertise, and active research of the PD/PI. Relate these strengths to the proposed management of the training program. Describe the planned strategy and administrative structure to be used to oversee and monitor the program. If there are multiple PDs/PIs, then the plan for Program Administration is expected to synergize with the Multiple PD/PI Leadership Plan section of the application.

Describe the relationship and responsibilities of the PD/PI and the Research Director. When a program administrator position is planned, a description of the scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

Institutions with existing programs must explain what distinguishes this program from the others, how their programs will synergize with one another, if applicable, and make it clear that the pool of faculty, potential scholars, and resources are robust enough to support additional programs. For example, those institutions with a current K12 Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Program, with a focus on women's reproductive health and/or located in a Department of Obstetrics and Gynecology or a department providing obstetrical and/or gynecologic care as its primary function, must demonstrate how the addition of a WRHR Program will provide career development training that is separate and distinct from that offered by the BIRCWH Program, including avoidance of overlap in terms of research topics and personnel.

Program Faculty. The application must include information about the program faculty who will be available to serve as preceptors/mentors and provide guidance and expertise appropriate to the level of trainees proposed in the application. Describe the complementary expertise and experiences of the proposed Program Faculty, including active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring and training individuals at the proposed career stage(s). For any proposed Program Faculty lacking research training experience, describe a plan to ensure successful trainee guidance by these individuals. Describe the criteria used to appoint and remove faculty as Program Faculty and to evaluate their participation.

The established investigators, as mentors, will make available their expertise, guidance, and laboratory facilities to be utilized by WRHR Scholars for research projects that will enhance their knowledge and skills. Mentors must interact closely with the Scholar in order to develop a tailored career development plan. Mentors must be committed to continue their involvement throughout the WRHR Scholar's total period of development under the award.

Proposed Training. Provide an overview of the proposed program. Outline the objectives of the program and the program activities that will be used to meet these objectives. Describe for whom the training program is intended, including the training level(s) of the trainees, the academic and research background needed to pursue the proposed training, and, as appropriate, plans to accommodate differences in preparation among trainees. Include information about planned courses, mentored research experiences, and any activities designed to develop specific technical skills or other skills essential for the proposed research training. Describe how trainees will be educated in the human health- and disease-related aspects of their research training.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, and to evaluation of the training program.

Program Evaluation. Describe a plan to review and determine the quality and effectiveness of the training program. This plan should include the metrics to be evaluated (including program activities completed, degree completion (if applicable), publications, fellowships/honors, and subsequent positions) as well as plans to obtain feedback from current and former trainees to help identify weaknesses and to provide suggestions for program improvements. Specified evaluation metrics should be tied to the goals of the program.

Scholar Candidates. Describe, in general terms, the size and qualifications of the pool of scholar candidates including information about the types of prior clinical and research training and career level required for the program. Do not name prospective scholars. Describe specific plans to recruit candidates and explain how these plans will be implemented (see also section on Recruitment and Retention Plan to Enhance Diversity). Describe the nomination and selection process to be used to select candidates who would be offered admission to the program and criteria for scholars reappointment to the program.

The application should describe plans for scheduling scholar appointments. Support for Scholars should be provided through a minimum of two consecutive 12-month appointments, renewable in annual increments, for up to five years total. New scholar appointments may be made at any time during the year. Support of Scholars is renewable at the discretion of the PD/PI, contingent upon presentation of evidence of satisfactory progress as determined by the Advisory Committee. Each WRHR Scholar appointed under the K12 award must be assigned one or two mentors based on the scholar’s research experience and need for intensive supervision and support.

Institutional Environment and Commitment to the Program. The sponsoring institution must assure support for the proposed program including assurance that sufficient time will be allowed for the PDs/PIs and other Program Faculty to contribute to the proposed program, and that there will be protected time for scholars (9 person months, equivalent to 75%) selected for the program. The application must include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. This commitment may also include features such as PD/PI salary, stipend or tuition support for individuals involved in the proposed training program, or other commitments essential to a successful training program. Institutions with ongoing research training, student development, or career development programs that receive external funding should explain what distinguishes the proposed program from existing ones at the same trainee level, how the programs will synergize, if applicable, whether trainees are expected to transition from one support program to another, and how the training faculty, pool of potential trainees, and resources are sufficiently robust to support the proposed program in addition to existing ones.

Recruitment and Retention Plan to Enhance Diversity

Individuals are required to comply with the instructions for Recruitment and Retention Plan to Enhance Diversity as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in Chapter 8 of the SF424 (R&R) Application Guide.

Progress Report

Renewal applications must provide brief summaries of the overall career development program that has been successful in preparing scholars for careers as independent investigators. Include information on the career outcomes of all scholars that have entered your program over the course of the award. The summary should contain information on their promotions, publications, support from research grants or contracts, honors and awards, and other relevant professional activities. Include measures of success consistent with the nature and duration of the training period, and additional information helpful in evaluating the impact of your WRHR Program.

Data Tables

Particular attention must be given to the required Training Data Tables. These tables are not counted toward the page limits of the Program Plan. Please read the Introduction to the Data Tables linked on the above web site before starting to prepare the tables.

New Applications must include the following tables: Table 2, Table 4, Table 6B, Table 9B and Table 10. All other data tables listed in the SF424 (R&R) Application Guide do not apply.

Renewal applications must include the following tables: Table 2, Table 4, Table 6B, Table 10, Table 12B. All other data tables listed in the SF424 (R&R) Application Guide do not apply.

Please summarize the data in the body of the application and provide any explanatory notes at the bottom of the data tables themselves. Use the data to support the presentation of your training program as described in the body of the application.

Additional custom tables may be included in the Research Training Program Plan. However, such tables will count as part of the page limit.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. .

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Career Development Program and Environment

• Does the proposed program clearly outline a plan to recruit and develop well-qualified junior investigators for successful careers as biomedical or clinical researchers?
• Is there evidence of an adequate pool of potential scholars who could benefit from receiving career development support?
• Are the content and duration of any proposed didactic, training-related, and research-related activities of the program appropriate?
• Are appropriate timelines indicated for career progression and transition to independence?
• Does the institutional environment (e.g., research facilities and other relevant resources) in which the program will be conducted contribute to the probability of success?
• Does the proposed career development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements?
• Is the institutional commitment to the proposed program appropriate?
• If multiple sites are participating, is this adequately justified in terms of the career development and research experiences provided? Is there sufficient assurance that the required effort of the PD/PI, mentors and scholars will be devoted directly to the research training, career development, and related activities?
• When applicable, is there adequate documentation describing the responsibilities of the advisory committee with regard to the provision of input, guidance and oversight of the program?

Will the WRHR program have an important impact on the capacity of the grantee institution to develop well-qualified new ob/gyn investigators, thereby advancing ob/gyn research locally and nationally, especially with regard to the application of basic research developments to clinical problems in ob/gyn?

For institutions with other institutional training programs (e.g., T32, K12, KL2), is there adequate justification for an additional program, will there be synergistic relationships among the programs, and are there effective plans to avoid overlap of research topics and personnel?

If there are NIH-supported Centers or other large research projects at the applicant institution, are there plans to take advantage of the resources provided for the benefit of the proposed WRHR Program?

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

Do the PD/PI and Research Director (if applicable) have the experience to develop, direct and administer the proposed program?

Does the leadership team bring complementary and integrated expertise to the program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure program objectives?

Are the research qualifications, scientific stature, previous leadership and mentoring experience, and track record(s) appropriate for the proposed career development program?

Is the PD/PI and/or Research Director (if applicable) currently engaged in research relevant to the scientific area of the proposed program?

Mentors

• Do the mentors have appropriate expertise and experience, as well as track records of past mentoring and training?
• Are the quality and extent of the mentors roles in providing guidance and scientific advice to the scholars acceptable? Are the mentors currently engaged in relevant research?
• Are the mentors established investigators supported by NIH or other competitively awarded grants and acknowledged experts in basic science methodology, translational and/or clinical research?
• Are the mentors' research interests relevant to the overall mission of the WRHR?
• Are the aggregate interests of established investigators broadly based and not too narrowly defined by a specific disease category or organ system?
• Is the number of proposed established investigators who will serve as mentors adequate?

Candidates/Scholars

Is a recruitment plan proposed with strategies likely to attract high quality scholar candidates?

Are there well-defined and well justified recruitment and selection strategies?

Is there evidence of a sufficiently large, competitive scholar pool to warrant the proposed size of the career development program?

Are the content, phasing, and proposed duration of the career development plan appropriate for achieving scientific independence of the scholar candidates?

What is the likelihood that the career development plan will contribute significantly to the scientific development of the scholars?

Does the plan for selection of the scholars include all of the eligibility criteria stated in the FOA?

Is the career development plan tailored to the needs of the prospective candidates?

Does the application demonstrate an adequate pool of prospective junior investigators, trained locally or recruited from elsewhere, who could benefit from receiving career development support from the WRHR Program at this site?

Is there evidence of a scientifically sound and equitable system for evaluating candidates for scholar positions and providing internal quality control of ongoing research?

If the institution has other institutional training programs (e.g., T32, K12, KL2), are there enough high-quality scholar candidates and faculty mentors to support an additional program?

Training Record

Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific careers?

Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period, including on the Recruitment and Retention Plan to Enhance Diversity, and Training in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the past funding period(s)? Are changes proposed that would improve or strengthen the career development experience? Is there evidence of a successful past training record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific research careers?

Renewal Applications:

• Is there sufficient evidence of past and current success of the scholars in producing research publications and in applying for and obtaining independent, competitively funded support for women’s reproductive health research?

• Are those scholars engaged in research at the present time as judged by their current position, publications, and evidence of independent support?

• What are the quality, overall impact, and effectiveness of the institution’s career development program in training and producing independent obstetrician-gynecologist investigators?

• Does the past performance demonstrate superior mentoring capabilities as evidenced by current and past career development programs?

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Recruitment & Retention Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment and retention plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the career development program, the level of scholar experience, and the particular circumstances of the scholar, the reviewers will evaluate the adequacy of the proposed RCR career development in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all career development faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NICHD in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.

• Availability of funds.

• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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

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

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

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

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

Not Applicable

The Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) and financial statements as described in the NIH Grants Policy Statement are required annually. Continuation support will not be provided until the required forms are submitted and accepted. Chapter 8 of the SF424 (R&R) Application Guide, Additional Instructions for Preparing a Progress Report for an Institutional Research Training Grant, Including Ruth L. Kirschstein National Research Service Awards, must be followed.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

• The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar appointed for eight weeks or more. Grantees must submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at xTrain (eRA Commons). An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

• A notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Individuals with a Conditional Permanent Resident status must first meet full (non-conditional) Permanent Residency requirements before receiving support.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement. Evaluation results should be included as part of the final Progress Report.

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

Estella Parrott, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6971
Email: [email protected]

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-451-3415
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.