RELEASE DATE:  June 9, 2004

RFA NUMBER:  RFA-HD-04-014  

Update: The following update relating to this announcement has been issued:

  o November 20, 2008 - This RFA has been reissued as (RFA-HD-08-014).

EXPIRATION DATE:  August 28, 2004

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH) 
National Institute of Child Health and Human Development (NICHD) 
Office of Research on Women's Health (ORWH)




o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations


The National Institute of Child Health and Human Development (NICHD) and the 
NIH Office of Research on Women's Health (ORWH) invite institutional career 
development award applications for Women's Reproductive Health Research Career 
Development Programs, hereafter termed "Programs."  These K12 Program grant 
awards will support research career development of obstetrician-gynecologists, 
to be known as Women's Reproductive Health Research (WRHR) Scholars, who have 
recently completed postgraduate clinical training, and who are commencing 
basic, translational, and/or clinical research relevant to women's health. The 
goal of this initiative is to promote the performance of research and transfer 
of findings that will benefit the health of women. The Programs will 
accomplish this by bridging clinical training with research independence, 
increasing the number and skills of obstetrician-gynecologist investigators at 
awardee institutions through a mentored research experience leading to an 
independent scientific career addressing women's reproductive health concerns. 
This program will result in a well-qualified cadre of academic obstetrician-
gynecologist investigators who will help strengthen the research capacity in 
health professional institutions and meet the need for highly skilled 
scientists with a clinical background who can address the increasing research 
opportunities in women's health.



This initiative addresses a continued need for expanded support for bridging 
clinical training with an independent career in research addressing women's 
health concerns. Awards resulting from this RFA would meet this specified need 
by providing departments of Obstetrics and Gynecology, both developing and 
established, an opportunity to build a national capacity for junior 
investigators in women's health research. One objective of this initiative is 
to promote the performance of research and transfer of findings that are 
relevant to women's reproductive health. Investigators with established 
research programs covering a broad range of basic and applied biomedical and 
biobehavioral science in the Obstetrics-Gynecology and collaborating 
departments will form an intellectual and technical research base for 
mentoring WRHR Scholars. 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-
gynecology and/or its subspecialties. 

The Women's Reproductive Health Research Career Development Program was 
initiated by NICHD in 1998 in response to concerns about the need for greater 
numbers of physician scientists in women's health research. This initiative 
continues and expands the scientific objectives represented in RFA-HD-98-004, 
RFA-HD-99-001, and RFA-HD-03-020 and that were responsive to the 1992 
Institute of Medicine Report, "Strengthening Research in Academic OB/Gyn 
Departments," the 1997 NICHD Extramural Program Five-Year Plan Report: "A 
Research Agenda for the Reproductive Sciences Branch," and report language in 
the Fiscal Year 1998 House Appropriations Report (No. 105-205; July 25, 1997). 

This RFA represents an expansion of ongoing research efforts to increase the 
numbers of physician scientists and support the research career development of 
junior faculty. Moreover, this initiative reflects the NICHD research agenda 
for expanding the scope of women's reproductive health research. 

Research Scope

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


This RFA will use the NIH Mentored Research Scientist Development Program 
(K12) award mechanism. The K12 awards will be for a period of five years. 
Planning, direction, and execution of each component of the research and 
career development program will be the responsibility of the Principal 
Investigator and WRHR Scholar, with the guidance of his or her mentor. 
As an applicant you will be solely responsible for planning, directing, and 
executing the proposed project. The anticipated award date is April 01, 2005.


The NICHD intends to commit approximately $3.2 million in total costs [Direct 
plus Facilities and Administrative (F & A) costs] in FY 2005 to support up to 
eight new and/or competing continuation grants in response to this RFA.  The F 
& A costs for this award may not exceed eight percent of modified total direct 
costs.  An applicant may request a project period of up to five years and a 
budget for total costs of up to $400,000 per year.  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 the NICHD provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications. At this time, 
it is not known if this RFA will be reissued. 


You may submit an application if your institution has any of the following 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments 
o Eligible agencies of the Federal government  
o Domestic institutions/organizations

Eligible institutions are those that will not have a current WRHR Program at 
the time of the award. Foreign institutions are not eligible for this award.

Applications may be submitted on behalf of departments of Obstetrics and 
Gynecology. An eligible institution will have 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 in the United States of America. Applicant 
institutions must have the clinical specialties and subspecialties and the 
clinical and research facilities sufficient to meet the purposes of the WHRH 
program, namely, to bridge clinical training with a career in basic, 
translational and/or clinical research relevant to women's reproductive 

Those 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 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.


Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with his/her institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

The Principal Investigator of a Program must be the Chair of the Department of 
Obstetrics and Gynecology or equivalent. He/she should possess the scientific 
expertise, leadership, and administrative capabilities required to coordinate 
and supervise a multidisciplinary research and development program of this 


A. Special Programmatic Requirements

Applicants must address the following specific program elements:

1. Eligible WRHR Scholars:  The Scholar position is a junior faculty 
appointment, not a fellowship. At the time of the award, candidates for 
support as WRHR Scholars must: (1) be a physician holding the M.D. or D.O. 
degree; (2) have completed postgraduate residency training in obstetrics-
gynecology or postdoctoral fellowship training in its subspecialties, if they 
have chosen to subspecialize; (3) identify an approved mentor with extensive 
research experience; (4) be able to spend at least 75 percent of full-time 
professional effort conducting research and research career development; (5) 
not be or have been a Principal Investigator on an R01, R29 or subproject of a 
Program Project (P01), Center (P50, P60, U54) grant, mentored career 
development (K-series) grants, or other equivalent research grant awards, 
except for R03 and R21 grants; and (6) be a U.S. citizen or noncitizen 
national, or must have been lawfully admitted for permanent residence and 
possess an Alien Registration Receipt Card (I-151 or I-155) or some other 
verification of legal admission as a permanent citizen. Individuals on 
temporary or student visas are not eligible. 

Programs are encouraged to recruit members of underrepresented minorities, 
individuals from disadvantaged backgrounds, women, and candidates with 
disabilities in order to address issues of diversity at the institution or 
within the relevant sciences nationally. 

Completion of subspecialty training is not required of candidates practicing 
general obstetrics and gynecology. However, those who choose to subspecialize 
must have completed their fellowship. 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, Scholars 
cannot have more than six years of research training experience beyond their 
last doctoral degree. 

Support is in the form of a minimum of two consecutive 12-month appointments, 
renewable in annual increments for up to five years total, and is contingent 
upon satisfactory progress as reported to the Advisory Committee and to NICHD 
in the annual progress report of the Program. 

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 mentored K awards 
(e.g., K08 or K23) at the conclusion of this award. WRHR Scholars should 
contact NICHD staff or staff from other ICs to determine eligibility prior to 
submitting an application. 
During the period of this award, WRHR Scholars are encouraged to apply for, 
and may accept and hold NIH research grant support and other independent 
research grant support with the consent of NICHD Staff. Independent NIH 
research grant support must conform to all NIH policies and guidelines as 
described in the NIH Guide for Grants and Contracts on November 14, 2003 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html) and 
requires the consent of NICHD Staff. 

New Scholar appointments to the Program are made after approval by NICHD 
Staff. New Scholar appointments will have start dates of July 1 and January 1. 

2. Program Composition:  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 scholars, including women and 
minorities, in biomedical careers. The 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 areas of research interest 
and need in 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. Of major importance, the Program must have a scientifically sound 
and equitable procedure for recruiting and selecting WRHR Scholars and 
projects to be supported. There must be documented evidence of an 
institutional commitment to support the Program's human and tangible resources 
and to its goal of developing and retaining productive, independent 
investigators in areas of women's reproductive health concerns. 

There should be a plan for ongoing evaluation of the Program in terms of 
recruitment and retention goals, including for women and minorities, 
completion success, overall outcome, the curriculum, and program staff. For 
purposes of evaluating the impact of research career development programs, 
awardees must agree to provide NICHD with information on career outcomes for 
those appointed to the program. The Principal Investigator will supply this 
information at least annually. There should be a plan for periodic research 
meetings and networking for all Scholars and mentors. The NICHD will convene 
an annual meeting for Scholars and relevant program personnel at the NIH.

3. Principal Investigator:  The Principal Investigator of a Program must be 
the Chair of the Department of Obstetrics and Gynecology, or equivalent. 
He/she should possess the scientific expertise, leadership, and administrative 
capabilities required to coordinate and supervise a multidisciplinary research 
and career development program of this scope. 

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

4. Career Development Program:  The K12 award provides five years of funding 
for the Program. The Program will support 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 75 percent of the WRHR Scholar's full-time professional 
effort must be devoted to the K12 program per se. 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. 

5. Advisory Committee:  The Advisory Committee will be a group of scientists 
from the sponsoring department, and other departments or institutions as 
appropriate, with interests relevant to the Program's research. 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 Principal 
Investigator as to WRHR Scholar appointments, evaluates ongoing research 
activities annually (including the interaction and integrated nature of the 
Scholars' research experience), makes recommendations regarding their 
continuation, and makes recommendations to the Principal Investigator 
regarding priorities for use of the Resource Laboratory, if applicable. The 
committee may use institutional or outside consultants if needed. Plans to 
include 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.

6. Institutional Environment:  Applicant institutions should show commitment 
to the 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. Research facilities and training opportunities will be a 
critical part of the environment. Applicant institutions should provide a 
guarantee of 75 percent protected time for the WRHR Scholars for research. 
Applicant institutions should demonstrate commitment to recruitment and 
retention of racial and ethnic minorities and individuals with disabilities by 
collaborating with less research intensive and minority institutions.

7. Mentors:  Each WRHR Scholar appointed under the K12 award must have a 
primary sponsor who is recognized as an independent investigator and who is 
actively involved in basic, translational, and/or clinical research relevant 
to this initiative, and who has a successful record of providing research 
training of a type expected in this Program. An assigned mentor will provide 
guidance for the development of each WRHR Scholar assigned to the program. The 
mentor must be committed to continue this involvement throughout the WRHR 
Scholar's total period of development under the award. Mentors not included in 
this application must be approved by NICHD Staff before being assigned a 

8. Resource Laboratory:  The laboratory resources of the Program comprise the 
research laboratories of the established investigators serving as mentors, as 
well as a shared resource laboratory to be utilized by the mentors and the 
WRHR Scholars whose activities they will supervise. With strong justification, 
a shared Resource Laboratory may be requested as part of the Program, within 
the total budget limit. Such a resource would provide skilled technical 
services to complement and extend the capabilities of the mentors to promote 
the career development of the WRHR Scholars. The shared Resource Laboratory 
might include scientific services such as, but not limited to, assays, 
molecular biology or biostatistics. Requests for this Resource Laboratory must 
be justified in terms of cost-effective enhancement of the research resources 
that will serve at least three WRHR Scholars' projects. The laboratories of 
the mentors are not supported directly by the K12 grant. The Resource 
Laboratory, if any, must be a new entity, not an extension or enhancement of 
an existing facility. The award may support professional direction of the 
Resource Laboratory, up to 50 percent effort, as well as technical assistance, 
supplies, equipment, and appropriate costs of operation. Institutional 
commitment to the shared Resource Laboratory must be demonstrated, and may 
take the form of providing or renovating space, purchase of required 
equipment, and/or support of personnel. The Principal Investigator, Program 
Director, and Resource Laboratory Director are responsible for efficient and 
equitable utilization of the Resource Laboratory based on recommendations from 
the Advisory Committee.

B. Budget and Related Issues

Allowable Costs:

1. The Program structure may have these elements:

a) Administration costs:  Salary and fringe benefits for the Program Director, 
if any, up to 10 percent effort, as well as a part-time secretary, may be 
requested. No compensation may be requested for the Principal Investigator. 
Travel to an annual NIH program meeting for the Principal Investigator and the 
Program Director, as well as travel to an annual NIH meeting for current 
Scholars, must be requested. Travel may also be requested for one additional 
training or scientific meeting per year for current Scholars.

b) Resource Laboratory costs:  Budgets may include salaries and fringe 
benefits for a Resource Laboratory Director (up to 50 percent), other 
technical staff, supplies, animals, and equipment purchase and maintenance. 
The budget for the Resource Laboratory must be included in the Administration 
cost. The sum of the budgets for Administration and a Resource Laboratory may 
not exceed $100,000 total costs (direct plus F & A costs) per year.

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

2. As part of the Scholars' costs, an application must request a minimum of 
three WRHR Scholar positions. The NIH will provide support for each WRHR 
Scholar position of up to $100,000 total costs (direct plus F & A) per year. 

a) Salary Support:  Scholars may be provided salary support of no more than 
$75,000 plus fringe benefits annually. 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. Institutional supplementation of salary must not require extra duties 
or responsibilities that would interfere with the purpose of the Program. The 
total salary requested for each WRHR Scholar must be based on a full-time, 12-
month staff appointment. It must be consistent both with the established 
salary structure at the institution and with salaries actually provided by the 
institution from its own funds to other staff members of equivalent 
qualifications, rank, and responsibilities in the department concerned. If 
full-time, 12-month salaries are not currently paid to comparable staff 
members, the salary proposed must be appropriately related to the existing 
salary structure.

b) 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, which can include expenses such as (1) travel to training or 
scientific meetings; (2) tuition, fees, and books; (3) 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 candidate's research 
activities. They cannot be pooled and used for other programs unrelated or 
indirectly related to the research activities of individual scholars. 

Grant funds may not be requested for the following:  Compensation for the 
Principal Investigator or mentors; direct support of the mentors' 
laboratories; compensation of administrative personnel normally paid from 
institutional overhead charges; administrative activities such as public 
relations, or health or educational services; travel of the Principal 
Investigator, Program Director or mentors to scientific meetings; costs of 
clinical care; and alterations and renovations.

c) 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 
o 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.
o The funds may be used for health-related research purposes.
o 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 

C. Special Reporting Requirements

1. Progress Reports:  The K12 award is not subject to the streamlined non-
competing application process (SNAP). This means that all reporting of 
budgetary information and progress of the Program and Scholars is provided in 
greater detail in an annual report. An Annual Progress Report for the grant is 
required. This report should provide information such as any changes in the 
Program, a summary report of the evaluation of the Advisory Committee, and a 
detailed description of the research and career progress of each Scholar. 

2. Final Progress Report:  A final progress report, invention statement, and 
Financial Status Report are required upon termination or relinquishment of an 

3. Evaluation:  In carrying out its stewardship of human resource-related 
programs, the NICHD may begin requesting information essential to an 
assessment of the effectiveness of the Programs. Accordingly, awardee 
institutions are hereby notified that WRHR Scholars may be contacted after the 
completion of their career development experiences for periodic updates on 
various aspects of their employment history, publications, support from 
research grants or contracts, honors and awards, professional activities, and 
other information helpful in evaluating the impact of the Program.

D. Special Administrative Requirements

1. Special Leave:  Candidates appointed to this program career award may 
engage in research experiences at another institution, including a foreign 
site, if 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 NICHD is required. To obtain 
prior approval, the Principal Investigator must submit a letter describing the 
plan, countersigned by the appropriate institutional official, to the NICHD. A 
copy of a letter or other evidence from the performing institution where the 
leave is to be taken must be submitted to assure that satisfactory 
arrangements have been made. Support from the career award will continue 
during such leave. 

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

2. Termination:  The Director of the NIH may discontinue a WHRH Program award 
upon determination that the purpose or terms of the award are not being 
fulfilled. In the event that an award is terminated, the Director of the NIH 
shall notify the grantee institution in writing of this determination, the 
reasons therefore, the effective date, and the right to appeal the decision.

3. Change of Institution:  The Program cannot be transferred from one 
institution to another.

4. Change of Principal Investigator and Program Director:  Awards are made to 
a specific institution for a specific Program under the guidance of a 
particular principal investigator and program director, if any. Changes in any 
of these parameters require prior approval by NICHD Staff under the following 

a) The current Principal Investigator or the awardee institution has submitted 
a written request to NICHD Staff for change of Principal Investigator or 
Program Director, countersigned by the appropriate institutional business 
official, describing the reasons for the change. The Biographical Sketch of 
the proposed new Principal Investigator or Program 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 Principal 
Investigator or Program Director will remain unchanged, and that the new 
Principal Investigator or Program 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.

5. Changes of Program:  Awards are made to a specific institution for a 
specific Program under the guidance of a particular Principal Investigator. 
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.


We encourage inquiries concerning this RFA 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 

o Direct your questions about scientific/research issues to:  

Estella Parrott, M.D., M.P.H.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8B01, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-6515
FAX: (301) 496-0962
Email: ep61h@nih.gov

o Direct your questions about peer review issues to:  

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-1485
FAX: (301) 402-4104
Email: stretchr@mail.nih.gov

o Direct your questions about financial or grants management matters to:  

Annette Hanopole
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 435-6975
FAX: (301) 402-0915
Email: hanapola@mail.nih.gov 


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

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

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 NICHD staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:  

Estella Parrott, M.D., M.P.H.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, 8B01, MSC 7510
Bethesda, MD  20892-7510
Telephone: (301) 496-6515
FAX: (301) 496-0962
Email: ep61h@nih.gov


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS:  The instructions in the Form PHS 398 do not fully 
apply to the special needs of this grant application. Therefore, follow the 
modified instructions below in preparing an application for a Women's 
Reproductive Health Research Career Development Program (K12). These 
instructions have been adapted to accommodate the PHS 398 and the special 
needs of the K12 grant: 

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-04-014), 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 (PI) 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 Principal 
Investigator, Program Director, if any, Resource Laboratory Director, if any, 
and mentors. Do not list Advisory Committee members unless they are also 

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 and shared 
Resource Laboratory costs (if applicable). 

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. Resources:  Resources must be provided according to the instructions in 
Resources Format Page in the PHS 398.  

H. Specialized Program Information should be included: 

(1) Begin with an 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 RFA 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 

(2) The Scholar Candidate:  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 

(3) 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. 

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:  Describe the composition of the Advisory Committee, 
identifying by name and role the internal members, and the desired expertise 
(but not the name or affiliation) of external members, if any. Describe how 
the Advisory Committee will function in providing oversight of the 
development, implementation, and evaluation of recruitment strategies and the 
recruitment and retention of candidates. Describe how the Advisory Committee 
will monitor and evaluate candidates and carry out the evaluation of the 
overall effectiveness of the career development program. 

(5) Environment and Institutional Commitment to Candidate:  Describe the 
research infrastructure, facilities, etc., that are available and accessible 
to this Program. This includes the existence of funded laboratories and 
research activities that will meet and sustain the needs of the Program. 
Provide information establishing the commitment of the applicant institution, 
the Principal Investigator, and Program 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 assuring that Scholars participating in this Program will 
be guaranteed 75 percent protected time to devote to research and research 
career development. 

Collaborations between research-intensive and less-research-intensive 
institutions, and/or minority institutions, will be considered a strength. 

(6) 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 RFA that may be the foundation of a WRHR Scholar's research 
experience in the Program. The research experiences may include basic, 
translational, and 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 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 Program 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 Program 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. 

Applicants who will be using a General Clinical Research Center (GCRC) are 
requested to include a letter with the application from either the GCRC 
Program Director or the Principal Investigator. 

(7) Responsible Conduct of Research:  Applications must include plans for 
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. 

(8) Current WRHR Programs:  For eligible WRHR Programs submitting a competing 
continuation application in response to this RFA, provide brief summaries of 
the overall career development program that has been successful in preparing 
candidates for careers as independent investigators. Include information on 
the career outcomes of all Scholars that have entered your program over the 
course of the award. The summary should contain information on their 
promotions, publications, support from research grants or contracts, honors 
and awards, and other relevant professional activities. Include measures of 
success consistent with the nature and duration of the training period, and 
additional information helpful in evaluating the impact of your Program. 

(9) BIRCWH Program:  Those 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.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title and 
number must be typed on line 2 of the face page of the application form and 
the YES box must be marked.  The RFA label is also available at: 

SENDING AN APPLICATION TO THE NIH:  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
Bethesda, MD  20817 (for express/courier service)

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

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an application 
is received after that date, it will be returned to the applicant without 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within eight weeks.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA 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.  


Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NICHD.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.  

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NICHD in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will: 

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o Receive a written critique 
o Receive a second level review by the National Advisory Child Health and 
Human Development Council.


The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health. In the 
written comments, reviewers will be asked to discuss the following aspects of 
the application in order to judge the likelihood that the proposed program 
will have a substantial impact on the pursuit of these goals: 

Program Overall:

o 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. This includes the scientific and administrative expertise of the 
Principal Investigator and Program Director, if any, in preparing physician 
investigators for independent careers in basic, translational or clinical 

o Quality of immediate and long-term career objectives of the Program. 

o Quality of partnerships between research-intensive institutions and less-
research-intensive institutions and/or minority institutions (if any). 

o For current WRHR Programs submitting a competing continuation application, 
the quality, overall impact, and effectiveness of their career development 
program in training and producing independent obstetrician-gynecologist 

o For institutions with a current 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, 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, including avoidance of overlap in terms of 
research topics and personnel.


o Evidence of the availability of an adequate pool of potential WRHR Scholar 
candidates trained locally or recruited from elsewhere, who could benefit from 
receiving career development support.

o Quality of plans 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.

o Quality of efforts to develop a recruitment plan for women, individuals with 
disabilities, individuals from disadvantaged backgrounds, and those from 
racial and ethnic groups underrepresented in research.

Career Development Plan:

o Likelihood that the career development plan will contribute significantly to 
the scientific development of the candidates.

o Appropriateness of the content, the phasing, and the proposed duration of 
the career development plan for achieving scientific independence for the 
prospective candidates.

o Consistency of the career development plan with prospective candidates' 
career goals and the multidisciplinary aims of the RFA.

o Quality of the training in the responsible conduct of research.

Research Plan:

o Usefulness of the research plan as a vehicle for ensuring research training 
in women's reproductive health for all Scholars as described in the career 
development plan.


o Appropriateness of the faculty mentors' qualifications in the areas of 
research relevant to this RFA, including current and pending research grants.

o Quality and extent of the mentors' proposed roles in providing guidance and 
advice to candidates.

o Previous experience of the mentors in fostering the development of 

Resource Laboratory, if applicable:

o Nature and quality of the optional new Resource Laboratory: technical merit, 
scientific justification, evidence of cost-effectiveness, procedures for 
quality control, allocation of resources among multiple users, qualifications 
of the Resource Laboratory Director and technical staff, and probable utility 
to the research projects of the WRHR Scholars.


o Applicant institution's commitment to the Program's scientific development 
of the WRHR Scholars, and assurances that the institution intends the Program 
and the supported WRHR Scholars to be an integral part of its research 

o Adequacy of research facilities, including availability of a General 
Clinical Research Center, if applicable, and training opportunities, including 
demonstration of the research base.

o Quality of the environment for scientific and professional development, 
including opportunities for faculty positions that emphasize research.

o Applicant institution's commitment to the appropriate balance of research 
and clinical responsibilities, including guarantee of 75 percent protected 
time for research for each WRHR Scholar.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

subjects and protections from research risk relating to their participation in 
the proposed research will be assessed.  (See criteria included in the section 
on Federal Citations, below.)

plans to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below.)

be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.


BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.


Letter of Intent Receipt Date: July 27, 2004
Application Receipt Date: August 27, 2004
Peer Review Date: October 01, 2004
Council Review: January 01, 2005
Earliest Anticipated Start Date: April 01, 2005


Criteria that will be used to make award decisions include: 

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities


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 

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).  The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the participants 
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and 
Contracts, June 12, 1998: 

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 - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
a complete copy of the updated Guidelines is available at 
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 

The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects 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 that is available at 

policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 

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 (see 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.  
Applications that do not provide this information will be returned without 

Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public 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 

Applicants may wish to place data collected under this RFA 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.

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 

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to 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 
RFA 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 or Health 
Systems Agency review.  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 

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

H H S Department of Health
and Human Services

  N I H National Institutes of Health (NIH)
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