Expired RFA-HD-09-026: Women's Reproductive Health Research (WRHR) Career Development Program (K12)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
Office of Research on Women’s Health (ORWH), (http://orwh.od.nih.gov/)

Title: Women's Reproductive Health Research (WRHR) Career Development Program (K12)

Announcement Type

Update: October 28, 2014 - This RFA has been reissued as RFA-HD-15-011

This is a reissue of RFA-HD-08-014.

Request for Applications (RFA) Number: RFA-HD-09-026

Catalog of Federal Domestic Assistance Number(s)
93.865

Key Dates
Release Date: April 17, 2009
Letters of Intent Receipt Date: June 30, 2009
Application Receipt Date: July 28, 2009
Peer Review Date(s): October/November 2009
Council Review Date: January 2010
Earliest Anticipated Start Date: April 1, 2010
Additional Information to Be Available Date (Url Activation Date): N/A
Expiration Date: July 29, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. The purpose of this Funding Opportunity Announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women’s Health (ORWH) is to solicit 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.
Mechanism of Support. This FOA will utilize the NIH Mentored Clinical Scientist Development (K12) Award mechanism to provide support to an institution for development of independent clinical scientists.
Funds Available and Anticipated Number of Awards. The NICHD intends to commit $4,752,000 in total costs to support this program in FY 2010. It is anticipated that up to 10 awards may be made.
Budget and Project Period. The total project period for an application may not exceed five years. Direct costs are limited to $440,000 per year.
Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs). The Program Director/Principal Investigator must be a chairperson of a Department of Obstetrics and Gynecology of an eligible institution. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Number of Applications. Only one application per institution may be submitted.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications from the previous issuances (RFA-HD-03-020 and RFA-HD-04-014) are permitted in response to this FOA
Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
Application Materials. See Section IV.1 for application materials.
Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The purpose of this Funding Opportunity Announcement (FOA) issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women’s Health (ORWH) 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 research career development of obstetrician-gynecologists, to be known as WRHR Scholars. These K12 Program grant awards will ultimately result in a well-qualified cadre of academic obstetrician-gynecologist (ob/gyn) 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.

Background

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. 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.

Objectives and Scope

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.

Types of Research and Experimental Approaches

The research scope for applicants encompasses all areas of obstetrics and gynecology 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 for this FOA.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Mentored Clinical Scientist Development (K12) award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

2. Funds Available

The NICHD intends to award up to $4,752,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2010 to fund up to ten new and/or renewal (formally known as competing continuation application) grants in response to this funding announcement.

An applicant may request a project period of up to five years and a budget for direct costs of up to $440,000 per year. The F & A costs for this award may not exceed eight percent of modified total direct costs. Because the nature and scope of the proposed programs will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of NICHD provide support for this program, awards pursuant to this funding announcement are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Future year amounts will depend on annual appropriations.

The awards will have an anticipated start date of April 1, 2010 and continue through March 30, 2015.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
For-Profit Organization (Other than Small Business)
U.S. Territory or Possession
Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions

Foreign institutions are not eligible for this award.

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.

Institutions with existing K12 or other training 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. As an 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.

1.B. Eligible Individuals

The WRHR Program Director/Principal Investigator (PD/PI) must be the Chair of the Department of Obstetrics and Gynecology or equivalent. He or she 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.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. An institution may submit only one application in response to this FOA.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications from the previous issuances (RFA-HD-03-020 and RFA-HD-04-014) of this FOA are permitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.
Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: June 30, 2009
Application Receipt Date: July 28, 2009
Peer Review Date(s): October/November 2009
Council Review Date: January 2010
Earliest Anticipated Start Date: April 1, 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Estella Parrott, M.D., M.P.H.
Reproductive Sciences Branch
Center for Population Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 for courier/non-USPS service
Telephone: (301) 435-6971
Fax: (301) 496-0962
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Robert Stretch, Ph.D.
Division of Scientific Review
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 for courier/non-USPS service
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: [email protected]

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

Special Budgetary Requirements

Three budget pages are required. A Composite Summary Budget page and individual budget pages for the Administration Costs and Scholar Costs should be provided. Up to $65,000 in direct costs annually may be requested for the Administrative Budget. Up to $375,000 direct costs annually may be requested for three Scholars in the Scholars Budget.

Program Administration Costs

a) As indicated above, Program Administrative Costs should be provided on a separate budget page. As part of the Administrative Costs, an applicant may request up to $65,000 in direct costs per year.

b) No compensation may be requested for the Program Director/Principal Investigator (PD/PI).

c) Salary and fringe benefits for the WRHR Research Director if any, up to 10 percent effort. If the Program Director/Principal Investigator (PD/PI) serves a dual role (i.e., functioning as both the PD/PI and the WRHR Research Director) then up to 10% effort in salary and fringe may be requested.

d) Partial salary for a part-time program assistant is allowable and may be requested.

e) Partial salary for a dedicated recruiting officer is allowable and may be requested.

f) Travel to an annual WRHR Program meeting for the Program Director/Principal Investigator (PD/PI) and for the WRHR Research Director, as well as current Scholars must be requested. Travel may also be requested for one additional training or scientific meeting per year for current Scholars.

g) Minimal costs can be allocated for advertising and recruitment in order to attract the best candidates nationally.

h) Some laboratory costs may be provided to scholars to offset expenses generated during the mentored research phase of the scholar’s training. These costs may include partial salary support for technical assistants and biostatisticians.

i) Facilities and Administrative costs: F& A (formerly, indirect) costs will be reimbursed at eight percent of modified total direct costs.

Scholar Costs

a) As indicated above, funds for prospective Scholars should be provided on a separate budget page. As part of the Scholars' Costs, an applicant must request three WRHR Scholar positions. The NICHD will provide support for each WRHR Scholar position of up to $125,000 in direct costs per year.

b) Salary Support: Scholars are eligible for salary support of up to $100,000, in addition to fringe benefits, annually from the K12 award consistent with their institution's salary scale; this may not be supplemented with other Federal funds unless specifically authorized by that Federal program. The total salary requested must be based on a full-time, 12-month staff appointment and requires Scholars to devote a minimum of 9 person months (equivalent to 75 percent) of full-time professional effort to conducting career development and health-related research with the remaining effort being devoted to activities related to the development of a successful research career. For information regarding NIH policy on determining full-time professional effort for career awards, see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Program.

c) Research and Career Development Support: Within each WRHR Scholar's total award, up to $25,000 annually is allocated for research and career development support, activities, which can include expenses such as (1) travel to training or scientific meetings; (2) tuition, fees, and books; (3) research supplies and equipment; and (4) technical support and statistical or computer services. These research and development costs must be specifically documented for each individual candidate and must be specifically related to the Scholar’s research activities. They cannot be pooled and used for other programs unrelated or indirectly related to the research activities of individual Scholars.

Items that may NOT be supported with K12 grant funds include:

Compensation for the Program Director/Principal Investigator (PD/PI) or mentors
Direct support of the mentors' laboratories beyond those expenses directly attributable to the scholar's project;
Salary and support for central institutional administrative personnel (e.g., budget officers, grant assistants, and building maintenance personnel), which are usually paid from institutional overhead charges;
Salary and support for administrative activities such as institutional public relations or health and educational services;
Travel of the Program Director/Principal Investigator (PD/PI), the WRHR Research Director, or other established investigators to scientific meetings beyond those associated with the administration of the WRHR Program;
Patient care costs such as inpatient bed days or outpatient visits, except for clinical laboratory analyses essential for the Scholar’s research;
Alterations and renovations.

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

Components of a WRHR Program

Principal Investigator

The Program Director/Principal Investigator (PD/PI) of a WRHR Program must be the Chair of the Department of Obstetrics and Gynecology or equivalent. He or she 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. He or she makes the decisions regarding appropriate recipients of the program funds for research and career development, taking into consideration recommendations from the WRHR Advisory Committee. The Program Director/Principal Investigator (PD/PI) does not receive salary or fringe benefit support from the WRHR Program for this activity.

Administrative Staff

As an option, the Program Director/Principal Investigator (PD/PI) may appoint a co-investigator to serve as the WRHR Research Director with responsibility for some or all of the day-to-day operations of the WRHR Program. The WRHR Research Director should be an established investigator and have experience and qualifications complementing those of the Director/Principal Investigator (PD/PI). The WRHR Research Director should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a program for developing junior investigators. The WRHR Research Director should have a record of accomplishment in mentoring successful investigators.

Advisory Committee

The Program Director/Principal Investigator (PD/PI) must establish 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. It may include mentors. The two major functions of the committee are to evaluate: 1) applications from WRHR Scholar candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations to the Program Director/Principal Investigator (PD/PI) concerning WRHR 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. Plans to include committee members or consultants from outside institutions may be described, but such individuals should not be named. The committee is a formal part of the structure of the Program. It should meet regularly, and keep written minutes, which will be reviewed as part of a competing or noncompeting application. In addition, an annual evaluation by the Advisory Committee is recommended.

Mentors

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. The 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 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. 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 have track records in mentoring and training, and must interact closely with the Scholar in order to develop a tailored career development plan. The Program Director/Principal Investigator should consult with NICHD staff before assigning a mentor to a Scholar. Assigned mentors will provide guidance for the development of each WRHR Scholar appointed to the program. Mentors must be committed to continue this involvement throughout the WRHR Scholar's total period of development under the award. Mentors are not required to be members of the department of obstetrics and gynecology. Mentors will not receive support from the career development award.

Career Development Program

There must be documented evidence of an institutional commitment to support the WRHR Program's goal of developing and retaining productive, independent investigators in areas of women's reproductive health concerns. Support for junior investigators is designed to enhance their research skills, thereby providing a bridge between formal research training and the receipt of independent research grants. Applicants must describe or propose a multidisciplinary career development program that will maximize the use of relevant research and educational resources to foster education, training, mentoring, and professional development of WRHR Scholars, including women and minorities, in biomedical careers. The WRHR Program must have a strong research base, comprising the research investigations of established scientists who will provide expertise, resources, and mentoring to the WRHR Scholars. The research base must be broad and relevant to current and future areas of women's reproductive health. The environment should be one that will stimulate and increase the interactions between basic scientists and clinical investigators likely to benefit from mentored research career development. The Program must have a scientifically sound and equitable procedure for recruiting and selecting WRHR Scholars and their research projects supported by the Program. The Program Director/Principal Investigator, after considering recommendations from the Advisory Committee, will select junior faculty for WRHR Scholar appointments for the pursuit of research projects under the guidance and supervision of an established mentor.

The K12 award provides five years of funding for the Program. The Program will support three WRHR Scholars for periods of two to five years consisting of consecutive 12-month appointments. The program may be divided into two distinct phases, if appropriate: (1) the first one- to two-year basic and/or clinical science-training component, followed by (2) an intensive research experience under the general guidance of a qualified mentor. At least 9 person months (equivalent to 75 percent) of the WRHR Scholar's full-time professional effort must be devoted to the K12 program. The remainder of the recipient WRHR Scholar's time may be devoted to developing other clinical or academic pursuits consonant with the objectives of the award. The 75 percent minimum effort in this program is intended to be primarily devoted to research; however, Scholars may, as needed, receive formal didactic coursework to support their career development, which may include, for example, biostatistics, epidemiology, health economics, clinical evaluation sciences, and clinical trials. The program must include appropriate training in biomedical ethics and the responsible conduct of research. Both renewal and non-competing continuation WRHR grants are contingent on demonstration of good judgment in these decisions, as indicated by scientific progress, success of the junior investigators in competing for new research grants and contracts, and the development of new ob/gyn investigators.

WRHR Scholars, as well as the Program Director/Principal Investigator (PD/PI) and the WRHR Research Director are expected to attend an annual WRHR Program meeting. One purpose of this meeting is to allow Scholars to present their career development award-supported research to their peers and senior investigators. The Program Director/Principal Investigator (PD/PI) and the WRHR Research Director are expected to attend these meetings to demonstrate their support of both the Program and the junior investigators. In addition, they will have an opportunity at these meetings to exchange ideas about common problems and make suggestions to NICHD staff about possible modifications in the program. Career development award-supported research reported in peer review journals or at scientific meetings must acknowledge the support received through the WRHR Program.

WRHR Scholar Candidates

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 WRHR Program, candidates for support as WRHR Scholars must:

be a physician holding the M.D. or D.O. degree;
have completed postgraduate residency training in obstetrics-gynecology;
if the candidate has chosen to subspecialize, be in the final research year of postdoctoral fellowship 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 or subproject of a Program Project (P01), Center (P50, P60, U54) grant, independent mentored career development (K-series) grants, or other equivalent research grant awards. Individuals who are or were PD/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.
be a U.S. citizen or noncitizen national, or must have been lawfully admitted for permanent residence and possess a Permanent Resident Card (USCIS Form I-551) or some other verification of legal admission as a permanent citizen. Individuals on temporary or student visas are not eligible.

The Scholar position is a junior faculty appointment, not a fellowship or extension of a fellowship position. Completion of subspecialty training is not required of candidates practicing general obstetrics and gynecology. However, those who choose to subspecialize may be appointed to the K12 program in the final research year of subspecialty clinical fellowship training. That year would be counted as the initial part of the K12 experience, not an additional year in the K12 program. This policy is described in the NIH Guide for Grants and Contracts on May 3, 2007 (http://grants.nih.gov/grants/guide/notice-files/NOT-HD-07-016.html ).

In order to accommodate the needs of those interested in participating in this program who may have had a career hiatus because of family responsibilities, uniformed service, etc., there is no limit on time elapsed since completion of training. However, Scholar candidates cannot have more than six years of research training experience beyond their last doctoral degree. Prior to appointment of WRHR Scholars, the Program Director/Principal Investigator should discuss Advisory Committee recommendations with NICHD staff. New Scholar appointments may be made any time during the year.

The maximum duration of support for a Scholar under this award is five years. Support is in the form of a minimum of two consecutive 12-month appointments, renewable in annual increments for up to five years total. Support of Scholars is renewable at the discretion of the Program Director/Principal Investigator (PD/PI), contingent upon presentation of evidence of satisfactory progress to the Advisory Committee. The pool of potential Scholars and criteria for selecting WRHR Scholars must be described in the grant application. Institutions are encouraged to develop novel mechanisms for recruiting qualified OB/GYN physicians to become grant-supported investigators. Such mechanisms should include special efforts to recruit individuals from underrepresented racial and ethnic groups, individuals from disadvantaged backgrounds, and individuals with disabilities.

During the award period, the Scholars are encouraged and expected to seek and transition to independent grant support. WRHR Scholars are encouraged to apply for, and may accept and hold NIH research grant support and other independent research grant support during the final two years. Independent NIH research grant support must conform to all NIH policies and guidelines as described in the NIH Guide for Grants and Contracts (NOT-OD-08-065). Scholars may also be eligible for the NIH Extramural Loan Repayment Program (LRP) for clinical and pediatric investigators. More information about LRP can be found at http://www.lrp.nih.gov/ .

Individuals who have been previously supported by NIH or non-NIH independent career development awards are not eligible. During the period of this award, WRHR Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. However, Scholars may remain eligible for, apply for, and hold other individual mentored career development awards (e.g., K08 or K23) at the conclusion of this award. WRHR Scholars should contact NICHD staff or staff from other relevant ICs to determine eligibility.

Institutional Environment

The sponsoring institution should have a well-established record of success in developing independent investigators, and assure the protected time necessary for the Scholars to complete the approved career development program. Applicant institutions must show commitment to the WRHR Program's goals, and provide assurances that the institution intends the Program and the supported WRHR Scholars to be an integral part of its research endeavor. The sponsoring institution must also allow appropriate faculty to be mentors and provide the necessary facilities to carry out the program. Research facilities and training opportunities will be a critical part of the environment. Applicant institutions must provide a guarantee of 9 person months (equivalent to 75 percent) protected time for the WRHR Scholars for research. Applicant institutions should demonstrate a commitment to the recruitment and retention of underrepresented racial and ethnic minorities and individuals with disabilities by collaborating with less research intensive and minority institutions.

Evaluation

There should be a plan for ongoing evaluation of the WRHR Program in terms of recruitment and retention goals, including for women and individuals from underrepresented racial and ethnic populations, completion success rates, overall outcome, curriculum development, and institutional staff. There should be a plan for periodic internal research meetings and networking of all appointed Scholars and mentors.

WRHR Application Format Instructions

Applicant Institutions are required to include the following elements in their application:

Program Description: The application must include a description of the activities, such as didactic courses, specialized workshops or tutorials, which will be incorporated into the career development and mentored research experience phases of the program. The courses should be relevant to diverse areas of women s reproductive health research. It is expected that the didactic and research experiences provided by the Program will facilitate the ability of the participants to acquire the necessary knowledge and research skills in scientific areas relevant to their career goals. The WRHR Program may be designed to accommodate candidates with varying levels of research experience. This individualized design may require career development programs that range between two and five years, depending upon the Scholar.

The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Applicants should follow the modified instructions below in preparing an application for the Women’s Reproductive Health Research Career Development Program. These instructions have been adapted to accommodate the PHS 398 and this K12 program.

1. Face Page: Use Form Page 1 of the PHS 398. On Line 1, include the title that best represents the nature of the Career Development Program. On Line 2, provide the number of this Request for Applications (RFA-HD-), and the RFA title "Women's Reproductive Health Research Career Development Program (K12)." The Chair of the Department of Obstetrics and Gynecology will be the Principal Investigator of the grant application. Complete the rest of the Form Page 1 as directed in the PHS 398 instructions.

2. Description/Performance Site(s)/Key Personnel (Form Page 2 of PHS 398): Complete as directed in the PHS 398 instructions. The abstract description should summarize the actual proposal, including the candidate pool, research topics, goal of the program regarding career development and the environment.

The information provided under Key Personnel should include the Program Director/Principal Investigator, the WRHR Research Director, if any, and the mentors. Do not list Advisory Committee members unless they are also mentors.

3. The application should be organized as follows (when following this format, applicants should refer regularly to those sections of this announcement that delineate "special requirements" and "review criteria"):

A. Face Page

B. Description, Performance Sites, and Key Personnel

C. Table of Contents

D. Detailed Budget Page for Initial Budget Period: Budget requests must be provided according to the instructions in form PHS 398. A composite Form Page 4 for the entire Program budget request should be followed by one Form Page 4 for the Scholars' Costs and one Form Page 4 for Administration Costs.

E. Budget for Entire Proposed Period of Support: Provide Form Page 5 for the composite only. The requests for tuition and fees, books, travel, research development expenses, etc., must be justified and specified by category.

F. Biographical Sketches in the standard NIH format should be provided for all Key Personnel.

G. Other Support should be completed according to the instructions in the PHS 398.

H. Resources page should be completed according to the instructions in the PHS 398.

I. Checklist page should be completed according to the instructions in the PHS 398.

J. The description of the program’s plan. Applicants are strongly discouraged from giving programmatic URL’s in their applications, and reviewers are not obligated to view applicant’s web sites to review existing public information. Specialized Program Information should be included as follows:

(1) Overview of the proposed Program: Summarize the immediate and long-term objectives of the Program. Describe the background, purpose, and objectives of this career development Program. This description should include a discussion of the strategies to be used to ensure that the objectives of this FOA are met. The description should clearly show how the purpose and objectives meet the broader objectives and intent of NICHD to support the development of independent ob/gyn investigators in women's reproductive health.

(2) Statement by Sponsor: Summarize the immediate and long-term career objectives of the Program, explaining how the Program will contribute to their attainment. Describe the career development plans for prospective candidates. Considering the Program goals and the likely goals of prospective candidates, describe a plan to provide the necessary research background and experiences, considering the expected range of prior research training in the applicant pool. For example, candidates with little previous research experience may require a phased developmental period in which the first phase of support under this award may include the first year or two of didactic training in basic and/or clinical research sciences. For these candidates, a second phase would be an intensive, supervised research experience to complete a longer developmental program. More experienced candidates may benefit from entering immediately into a mentored research experience of at least two years supported by this award.

(3) The Scholar Candidates: Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training. Do not name prospective Scholars. Describe the criteria to be used for candidate evaluation for selection as WRHR Scholars. Describe plans to recruit candidates, including those from economically, socially, or culturally disadvantaged backgrounds, individuals with disabilities or from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences and explain how these plans will be implemented. Provide brief summaries of career development plans that the Program will employ. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences, and should distinguish the plan from fellowship training.

(4) Advisory Committee: A plan must be provided for the appointment of an Advisory Committee to monitor the progress of the WRHR Scholars. Composition, responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the Advisory Committee, identifying the role and the desired expertise of members. A plan for Advisory Committee approval and selection of Scholars should be included. 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 career development program. Note that Advisory Committee members do not need to be named in the application, particularly if they include individuals from outside the institution.

(5) Recruitment Plan: Applicants should include a plan describing selection procedures for recruiting scholars. The plan should include recruiting efforts to enhance diversity. The applicant institution must request support for three Scholars. Programs may appoint Scholars at any point during the fiscal year. Institutions are encouraged to design a program that is appropriate for their pool of potential candidates and participating faculty/mentors. The award provides support to institutions for up to five consecutive 12-month periods. Appointments are provided in 12-month increments with a minimum two-year appointment. Collaborations between research-intensive and less-research-intensive institutions, and/or minority institutions, will be considered a strength.

(6) Environment and Institutional Commitment to Program: The primary institution must have well-established research programs and highly qualified faculty mentors. Describe the research infrastructure, facilities, etc., that are available and accessible to this Program. This includes the existence of funded laboratories and research space and activities that will meet and sustain the needs of the Program. Provide information establishing the commitment of the applicant institution, the Project Director/Principal Investigator (PD/PI), the WRHR Research Director, if any, and the faculty mentors to providing developmental experiences that lead to independence in biomedical, behavioral, and/or clinical research relevant to women's reproductive health. Letters from faculty mentors are not required unless they are collaborators from other institutions. Include the specifics of institutional support. There is no dollar requirement, but significant commitment will be considered a strength of the application. Provide a statement from senior institutional officials assuring that Scholars participating in this Program will be guaranteed 9 person months (equivalent to 75 percent) protected time to devote to research and research career development.

(7) Research Plan: For each faculty member proposed as a potential mentor, provide a paragraph describing the proposed research relevant to the goals expressed in this FOA that may be the foundation of a WRHR Scholar's research experience in the Program. The research experiences may include basic, translational, and/or clinical research approaches to biomedical or behavioral problems in women's reproductive health. Lengthy, detailed protocols or plans for specific experiments should not be included. No limits are specified for the number of proposed mentors; however, fewer than six may not provide sufficient choice of projects, while more than 25 may dilute the focus on women's reproductive health. For each proposed mentor, describe the pertinent research experience and record of accomplishment in training junior investigators. In a table, name up to five current or former students or fellows the faculty member has trained, with dates (month/year), where trained, title of project, academic level, and present position and institution. Include a list of current funded research for each proposed mentor participating in the Program.

The proposed WRHR Research Director, if any, should have a record of accomplishment for mentoring successful investigators. Describe the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a program for developing junior investigators. Describe the career development record of the WRHR Research Director, as determined by the success of his/her former students or fellows. In a table, name up to five current or former students or fellows the faculty member has trained, with dates (month/year), where trained, title of project, academic level, and present position and institution. Include a list of current funded research.

(8) Instruction in the Responsible Conduct of Research: Every individual supported by a research career development award must receive instruction in the responsible conduct of research. Applications must include a description of plans to provide instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency, and duration of instruction, and the amount and nature of faculty participation. No award will be made if an application lacks this component (http://grants2.nih.gov/training/responsibleconduct.htm ).

(9) Evaluation and Tracking: Applicants are encouraged to set benchmarks for the goals of their institutional K12 Programs in advance. The application must include a plan for program evaluation in terms of recruitment and retention goals, curriculum assessment, mentoring, Scholar completion success, and overall outcome. For the purposes of evaluating the impact of this K12 program, awardees should agree to provide NICHD with information on the career outcomes of those appointed to the WRHR Program. Appointment of Scholars should be documented by a Statement of Appointment Form (Form 2271) and submitted to NICHD.

(10) Current WRHR Programs: For eligible WRHR Programs submitting a renewal application in response to this FOA, 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 who have entered your program over the course of the award. 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.

(11) Other K12 Programs: Those institutions with other K12 Programs should address how that program will be distinct from the WRHR Program. Specifically, institutions with a current 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 provide information on 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. In addition, provide brief summaries of the overall K12 career development program that has been successful in preparing Scholars for careers as independent investigators. Include information on the career outcomes of all Scholars who have entered other K12 programs over the course of those awards. Include measures of success consistent with the nature and duration of the training period, and additional information helpful in evaluating the impact of other K12 or BIRCWH Programs.

Research Plan Page Limitations

Not Applicable

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Not Applicable

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NICHD and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

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 impact/priority score.
Receive a written critique.
Receive a second level of review by 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 peer review
Availability of funds
Relevance of the proposed project to program priorities

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

Investigator(s). Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Program Director/Principal Investigator (PD/PI) and other researchers?

Innovation. Is the proposed career development program innovative?

Approach. Are potential problems, alternative strategies, and benchmarks for success presented?

Environment. Is there evidence of institutional support? Will the scientific environment in which the work will be done contribute to the probability of success? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score.

Career Development Plan: What is the probable impact of the Program award on enhancing the capacity of the grantee institution to develop well-qualified new obstetrician-gynecologist investigators, thus enhancing women's reproductive health research locally and nationally? What is the likelihood that the career development plan will contribute significantly to the scientific development and independence of the Scholar candidates? Will the Program provide individualized career development for Scholars? Is there adequate availability of research-oriented faculty positions at the grantee institution for new investigators previously trained by the WRHR? 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?

Institutional Commitment: Is the institutional leadership committed to this Program and its goals? Does the institution provide assurances that it intends the Program to be an integral part of its research endeavor? Have institutional barriers to training and career development been adequately addressed? Is there a commitment to 75% protected time for all WRHR Scholars? Is there evidence of institutional commitment to the requirements of the Program, such as recruitment efforts, salaries, or equipment? Is there evidence of cost-effectiveness and procedures for quality control in allocation of resources?

Mentors: Are the mentors established investigators supported by NIH or other competitively awarded grants and acknowledged experts in women’s reproductive health research? Are their research interests relevant to the overall mission of the WRHR? Is the number of proposed established investigators who will serve as mentors adequate? Is the previous experience of the mentors in fostering the development of junior researchers adequate? Are plans to mentor candidates appropriate?

Scholar Candidate Pool/Selection Process: Are there adequate plans to meet diversity objectives? 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 a well-defined selection process to identify, recruit, and select candidates with a commitment to research relevant to women's reproductive health, and the potential to develop as independent researchers? Is there evidence of a scientifically sound and equitable system for evaluating candidates for Scholar positions and providing internal quality control of ongoing research?

Recruitment: Has the grantee institution provided sufficient strategies to recruit Scholar candidates from among women, individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds? If the institution has partnerships between research-intensive institutions and less-research-intensive institutions and/or minority institutions, is the quality of the partnerships adequate to stimulate diversity?

Evaluation/Tracking Plan: Do the proposed plans adequately provide a means to receive meaningful feedback about the program? Is it clear how the Program will respond to feedback and incorporate suggestions? Is the system for monitoring Scholars career progression adequate to measure the quality and effectiveness of the Program?

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?

Institutions with a BIRCWH Program or other K12 Program: If the applicant currently has or has had another K12 program, did that program have sufficient high-quality Scholars and are those Scholars engaged in research at the present time as judged by their current position, publications, and evidence of independent support? Is there adequate consideration given to potential interactions with the proposed WRHR Program? Is there adequate information provided to understand what distinguishes the proposed WRHR Program from these other training-related or career development efforts? What is the effectiveness of the plan to keep the career development activities of the proposed WRHR Program separate and distinct from that offered by the BIRCWH Program or other K12 Program, including avoidance of overlap in terms of research topics and personnel? Are there enough high-quality Scholar candidates and faculty mentors to support an additional program?

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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

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

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).

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

1) Data Sharing Plan. Not Applicable

Sharing Model Organisms. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html )

3) Genome Wide Association Studies (GWAS). (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following related administrative policies apply to the K12 Program:

Other Income

Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
The funds may be used for health-related research purposes.
The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment.

Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

Special Leave

Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the NIH awarding institute or center is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.) A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the K12 award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component institute and will be granted only in unusual situations. Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

Under pressing personal circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50% effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75% as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

Changes of Career Development Program

Awards are made to a specific institution for a specific Program under the guidance of a particular Program Director/Principal Investigator (PD/PI). Changes in any of these parameters require prior approval by NICHD Staff. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed Program. The new program will be evaluated by NICHD Staff to ensure that the Program remains within the scope of the original peer-reviewed Program. If the new program does not satisfy this requirement, the award could be terminated.

Change of Institution

The K12 program may not be transferred to another institution.

Change of Program Director/Principal Investigator (PD/PI) and WRHR Research Director:

Awards are made to a specific institution for a specific Program under the guidance of a particular Program Director/Principal Investigator (PD/PI) and WRHR Research Director, if any. Changes in any of these parameters require prior approval by NICHD Staff under the following conditions:

(a) The current Program Director/Principal Investigator (PD/PI) or the awardee institution has submitted a written request to NICHD Staff for change of the Program Director/Principal Investigator (PD/PI) or the WRHR Research Director countersigned by the appropriate institutional business official, describing the reasons for the change. The Biographical Sketch of the proposed new Program Director/Principal Investigator (PD/PI) or WRHR Research Director including a complete listing of active research grant support is provided. The information in the request establishes that the specific aims of the original peer-reviewed program to be conducted under the direction of the new Program Director/Principal Investigator (PD/PI) or WRHR Research Director will remain unchanged, and that the new Program Director/Principal Investigator (PD/PI) or WRHR Research Director has the appropriate research and administrative expertise to lead the Program.

(b) The request is submitted far enough in advance of the requested effective date to allow the necessary time for review.

Termination

Consultation with NICHD staff is strongly encouraged when termination of the K12 program is being considered. When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the NoA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision period.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Progress Report

An Annual Progress Report for the grant is required. This report should provide information about changes in the Program, a summary of any ongoing evaluation results , a summary report from the Program Advisory Committee (including information about newly selected candidates, if applicable), and a description of the research and career progress of each candidate. An overview of each scholar's research accomplishments and goals for the coming year should be clearly stated. These Annual Progress Reports will be closely monitored by NICHD staff to ensure that the grant is achieving the goals of the WRHR program and to confirm that the institution is continuing to meet its goal of recruiting promising new ob/gyn investigators, and facilitating their career development.

The following information should be provided.

(1) Complete the Face Page A as instructed in the Form PHS 2590.

(2) Make three Budget pages

a. Administration Budget to include all program related costs other than Scholar support. All other administrative budgetary information (e.g., supplies, travel, research support) for each selected candidate should also be provided.

b. Scholars' Budget to include the categorical budget if Scholar is appointed and project is defined. The budget page should provide the salary and fringe benefits for each WRHR Scholar by name, as well as the research and development component costs.

c. Composite Summary Budget containing the Administrative and Scholars' budgets.

(3) Include completed updated other support information for the Program Director/Principal Investigator (PD/PI) and the WRHR Research Director, if any.

(4) Add biographical sketches, other support and other pertinent information for any new Key Personnel added since the last application. This includes new mentors, new Advisory Committee members, and newly selected WRHR Scholar candidates.

(5) Recruitment: What outreach was performed? Number of candidates applying, interviewed, and accepted, by sex, race/ethnicity, and disability.

(6). A summary of Advisory Committee roles and activities for the past year. Include the Advisory Committee minutes and if a program evaluation was performed, provide a summary.

(7) Individual Progress Report for each current Scholar: A brief summary for each appointed Scholar that describes the research and didactic training experiences completed and ongoing, as well as the specific plans for the upcoming year. Include information about the Scholar’s efforts to obtain independent support.

a. Scholar’s name and date entered and completed the program. If the Scholar left prematurely, please provide a reason.

b. For each WRHR Research Project, provide a Research Report. Follow the instructions for regular research projects using this outline: Title, Specific Aims, Studies and Results, Significance, Plans, Publications and Abstracts, and Project-Generated Resources. (Please Identify Peer Reviewed Publications.)

c. Research and Career Development (up to 25% effort): Describe course work, activities, and other non-WRHR research support. Include any future plans for next year.

d. List the following: Other Grant Support in which the Scholar is the PI (include grants applied for and awarded), Presentations, Awards or Other Recognition.

e. Mentor's Report: The primary mentor should provide a concise statement of the Scholar's progress and performance.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Estella Parrott, M.D., M.P.H.
Reproductive Sciences Branch
Center for Population Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-6971
Fax: (301) 496-0962
Email: [email protected]

2. Peer Review Contacts:

3. Financial or Grants Management Contacts:

Ms. Cecilia Bruce
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17L, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1304
Fax: (301) 480-4782
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.