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 FOA encourages applications from organizations that propose creative and innovative institutional research career development programs in the mission area(s) of the NIH.

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.

Program Objective

The NIH Office of Research on Women's Health (ORWH) and its co-sponsors announce institutional career development awards for Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Career Development Programs, hereafter termed "Programs." Programs will support mentored research career development of junior faculty members, known as BIRCWH Scholars, who have recently completed clinical training or postdoctoral fellowships, and who will be engaged in interdisciplinary basic, translational, behavioral, clinical, and/or health services research relevant to women's health, and where appropriate the use of both sexes to better understand the influence of sex as a variable on health.

The goals of this initiative are to increase the number and skills of investigators through a mentored research and career development experience leading to an independent scientific career that will benefit the health of women; advance research on sex/gender influences on health; and encourage interdisciplinary research methodology.

The BIRCWH Program is built around three pillars: interdisciplinary research, mentoring, and career development. Interdisciplinary mentoring teams are essential to the BIRCWH Program and defined as teams that include mentors from diverse disciplines to carry out interdisciplinary projects. Team members may include individuals from medical, dentistry, pharmacy, nursing, biotechnology, social sciences, anthropology, genetics, and other disciplines representing different perspectives and areas of expertise coming together to collaborate as a unit, with the common goal of supporting a BIRCWH Scholar in the transition from trainee to independent researcher. In this funding opportunity announcement (FOA), the interdisciplinary team approach is applied to the study of women's health across the lifespan, bridging basic and clinical science and incorporating new models of collaboration and institutional support. Proposed Programs must ensure the integration of interdisciplinary mentoring teams.

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

In order to foster the development of a diverse and highly trained workforce of women's health researchers to assume leadership roles related to the Nation's biomedical and behavioral research efforts in women's health, the NIH, ORWH and its co-sponsors invite applications for the establishment of career development programs in interdisciplinary basic, translational, behavioral, clinical and health services research in the Program director's/principal investigator's (PD's/PI's) sponsoring and collaborating departments, centers, or institutes to form an inter-professional, team-based approach for mentoring BIRCWH Scholars. Mentors from collaborating departments are encouraged to provide needed expertise and resources, as long as the emphasis of BIRCWH Scholars' projects is on research relevant to women's health, including research on sex and gender influences as well as research on factors that contribute to disparities in health status or health outcomes for different populations of women.

Background Information

In 2004, the National Academy of Sciences (NAS) Committee on Facilitating Interdisciplinary Research defined interdisciplinary research as a mode of research that integrates information, data, techniques, tools, perspectives, concepts, and/or theories from two or more disciplines or bodies of specialized knowledge to advance fundamental understanding or to solve problems whose solutions are beyond the scope of a single discipline or area of research practice. As such, interdisciplinary science teams work to advance fundamental understanding and solve problems that those from a single discipline could not (Fiore, 2008).

In the past decade, team science (also known as team-based research) has emerged, described as the approach to address complex scientific problems that necessitate the collaboration of multiple disciplines, fields, and professions with substantial integration and interaction. Recognizing the significance of this approach to advance research and sustain the research workforce, the Agency for Healthcare Research and Quality (AHRQ) and National Institute of Health (NIH) created resources of team-based approach information in education and training and toolkits.

The NIH FOA on Research on Causal Factors and Interventions that Promote and Support the Careers of Women in Biomedical and Behavioral Science and Engineering Causal Factors and Interventions (CFI) findings report the importance of both mentoring teams and team science in career development. This FOA encourages the team science research approach and utilization of interdisciplinary mentoring teams.

In addition, NAS, NIH, and other professional bodies have expressed concern at the prolonged time needed to achieve research independence (R01) for doctorate level investigators. This FOA will provide opportunities for an interdisciplinary, mentored career development experience that would otherwise not be available to help in the transition to research independence for junior faculty researchers who are conducting interdisciplinary research in women's health and sex difference research.

NIH Research on Women's Health

Moving Into the Future with New Dimensions and Strategies for Women’s Health Research: A Vision for 2020 for Women’s Health Research is the NIH strategic plan for Women's Health and Sex Differences Research for the decade ahead. Implementing the strategic priorities outlined in this strategic plan is underway. ORWH leads this effort aided by the NIH Institutes and Centers and by the NIH advisory and coordinating committees on research on women’s health. Research supported under this FOA needs to incorporate the goals and objectives of the NIH Strategic Plan for Women's Health Research; institutions should be able to show that the major focus of the research training is focused on women's health or the influence of sex and gender on health and disease.

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.

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 Career Development 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.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. An Advisory Committee is required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee and using their recommendations to recruit, select and monitor program's overall progress.

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 career development program. Program faculty should also have a record of research training, including successful, former Junior faculty 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.

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.

The scholar position is a junior faculty appointment, not a fellowship.

At the time of appointment, candidates for support as BIRCWH Scholars must:

• Have a clinical doctorate or Ph.D. degree or its equivalent;

• Have completed any postgraduate training normally expected for a faculty appointment in their field (including clinical or postdoctoral fellowship training, or residency if they have chosen not to subspecialize);

• Have no more than six years of research or research training experience beyond their last doctoral degree.

• Identify mentors with extensive research experience;

• Be able to spend at least 9 person months (or at least 6 person months for surgical-specialties) of full-time professional effort conducting research and research career development activities;

• Not be or have been a PD/PI on an R01 or subproject of a Program Project (P01), Center (P50, P60, P20, P30, U54) grant, independent mentored career development (K-series) grants, or other equivalent research grant awards; except for R03 and R21;

In keeping with the type of mentoring and career development being provided by the K12, a scholar who is already in the process of applying for an independent mentored career development grant, P01 grant, or R01 grant is likely to be too senior for the BIRCWH.

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:

Maggie Brewinski Isaacs, M.D., M.P.H.
Office of Research on Women’s Health (ORWH)
Telephone: 301-451-7082
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., postdoctora, and intended scholar outcomes.

Other Attachments. An Advisory Committee is a requirement for support under this FOA. Applicants should provide a plan for the appointment of an Advisory Committee to monitor progress of the career development program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Proposed Advisory Committee members should be named in the application if they have been invited to participate at the time the application is submitted. Renewal applications with Advisory Committees should include the names of all committee members during the past project period. 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).

Research Director. The PD/PI of the application may also serve as the Research Director with responsibility for the day-to-day operations of the Program. Alternatively, the application may designate an individual other than the PD/PI to serve as Research Director. In that case, the Research Director should be an experienced investigator and have experience and qualifications complementing those of the PD/PI, and the division of responsibility between the two individuals should be clearly described in the application.

Biographical Sketch. A description of the Research Director's scientific expertise, leadership, and administrative capabilities essential to coordinate a program for developing investigators must be included in the application.

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:

• The R&R Budget Component must be used instead of the Training Budget Component.

• 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.

• The applicant institution may request support for two scholars in each budget period.

• With strong justification, a shared Resource Laboratory may be requested as part of the Program, within the total budget. Such a resource must be a new entity, not an extension or enhancement of an existing facility. The Shared Resource Laboratory might include scientific services such as, but not limited to, assays, molecular biology or biostatistics. Requests for this Resource Laboratory must be justified in terms of cost-effective enhancement of the research resources that will serve at least four BIRCWH Scholars' projects.

• The salaries and laboratories of the mentors may not come directly from the K12 grant.

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:

Particular attention must be given to the required Training Data Tables.

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

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

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.

The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. An Advisory Committee is required. The PD/PI has responsibility for the day to day administration of the program and is responsible for appointing members of the Advisory Committee and using their recommendations to recruit, select and monitor program's overall progress. The PD/PI, Research Director (if one is included) and Resource Laboratory Director (if one is included) are responsible for efficient and equitable utilization of the Resource Laboratory on the basis of recommendations from the Advisory Committee.

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. 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.

Provide an overview of the proposed program: Describe the immediate and long-term objectives of the program, including training or career development activities that will be used to ensure that the objectives of the program are met. Include information about planned seminars, workshops, or tutorials that will be incorporated into the training program and mentored research experiences and activities, including individual development plans for each scholar. The PD/PI should also describe past track records in research training/career development including those of mentors, documenting the probability of success of the program.

Applicants should include a plan describing selection procedures for recruiting scholars. Scholar appointments should be based on the recommendation of the Advisory Committee. Support is in the form of a minimum of two consecutive 12-month appointments, renewable in annual increments up to five years total, and is contingent upon satisfactory progress as reported to the Advisory Committee.

Programs should provide all scholars with additional professional development skills and career guidance including instruction and training in writing applications for research funding in order to apply successfully for future career development and independent research support.

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.

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. In keeping with the importance of mentoring to the BIRCWH program, a description should be provided of the approach to mentoring that will be utilized in your program. BIRCWH Scholars should be assigned at least two mentors from different disciplines and training background for interdisciplinary research and career development. The research experiences may include basic, behavioral, translational, clinical, and/or health services research approaches to biomedical or behavioral problems in women s health. It is expected that assigned mentors will interact closely with the scholar and provide guidance to develop a tailored career development plan as part of an interdisciplinary mentoring team.

The description should clearly show how the purpose and objectives meet the broader research priorities identified by the NIH Office of Research on Women's Health to support the career development of junior faculty who are conducting interdisciplinary research in women's health.

After a review of the NIH Strategic Plan for Women's Health Research, programs may choose to have one or two themes if there is evidence of institutional strength for a particular focus. Lengthy detailed protocols or plans for specific experiments should not be included.

For renewal applications, highlight how the training program has evolved in response to changes in relevant scientific and technical knowledge, educational practices, program evaluations and feedback from current and former trainees.

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. Programs should describe methods of evaluating mentoring including the use of validated tools.

Trainee Candidates. Describe, in general terms, the size and qualifications of the pool of trainee 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 trainees reappointment to the program.

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. Institutional commitment to the shared Resource Laboratory, if included, must be demonstrated, and may take the form of providing space, purchase of required equipment, and/or support of personnel. 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. In keeping with ORWH's goal of enhancing and sustaining research careers, PDs/PIs should describe family friendly policies at their institution that support men and women in their research intensive careers.

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.

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 career development program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term career development. 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?

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

Do the PD/PI and Research Administrator (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?

Are the PD(s)/PI(s) currently engaged in research relevant to the scientific area of the proposed program?

For applications designating multiple PDs/PIs:

Is a strong justification provided that the multiple PD/PI leadership approach will benefit the career development program and the scholars?

Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the career development program and the complementary expertise of the PDs/PIs?

Specific to this FOA

Do the research/research training experiences conducted by the PD/PI focus on women's health research or research on the influence of sex and gender on health and disease?

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?

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?

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 are likely to improve or strengthen the research training experience during the next project period? Is there evidence of a successful past training/career development record of the PD/PI and mentors, including the success of former scholars in seeking independent support and establishing productive scientific research careers?

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 training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training 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 training 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 the Center for Scientific Review 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. Following initial peer review, recommended applications will receive a second level of review by the Eunice Kennedy Shriver, National Advisory Council on Child Health and Human Development . 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 or reappointed to the career development grant. 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.

• Termination Notice: Within 30 days of the end of the total support period, the institution must submit a Termination Notice (PHS Form 416-7) via xTrain for each scholar appointed for eight weeks or more.

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]

Maggie Brewinski Isaacs, M.D., M.P.H.
Office of Research on Women’s Health (ORWH)
Telephone: 301-451-7082
Email: [email protected]

Caroline Dilworth, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7727
Email: [email protected]

Lisa Halvorson, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-480-1646
Email: [email protected]

Chyren Hunter, Ph.D.
National Institute on Aging (NIA)
Telephone: 301 494-9322
Email: [email protected]

Lynn King, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5006
Email: [email protected]

Tamara Lewis Johnson, M.B.A, M.P.H.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-7942
Email: [email protected]

Samia Noursi, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-5622
Email: [email protected]

Bernadette Tyree, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5034
Email: [email protected]

Cora Lee Wetherington, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1319
Email: [email protected]

Denise Wiesch, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-437-3478
Email: [email protected]

Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone: 301-933-6196
Email: [email protected]

Barbara Gittleman
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0585
Email: [email protected]

Lesa McQueen
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: [email protected]

Melinda Nelson
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-5278
Email: [email protected]

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Donna Sullivan
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2979
Email: [email protected]

Ted Williams
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301- 326-6450
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.