Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Office of Research on Women's Health (ORWH), (http://www4.od.nih.gov/orwh/)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/default.htm)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)

Title: Building Interdisciplinary Research Careers in Women's Health (K12)

Announcement Type
This is a reissue of RFA-OD-05-002 previously released on November 24, 2004.

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

• July 21, 2011 - This RFA has been reissued as RFA-OD-11-002.
• July 17, 2009 - This RFA has been reissued as (RFA-OD-09-006).

• Purpose: The NIH Office of Research on Women's Health (ORWH) and its cosponsors invite institutional career development award applications for Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Career Development Programs, hereafter termed "Programs." Programs will support mentored research career development of junior faculty members, known as BIRCWH Scholars, who have recently completed clinical training or postdoctoral fellowships, and who will be engaged in interdisciplinary basic, translational, behavioral, clinical, and/or health services research relevant to women's health or sex/gender factors. The goal of this initiative is to increase the number and skills of investigators through a mentored research and career development experience leading to an independent scientific career that will benefit the health of women, including research on sex/gender similarities or differences in biology, health or disease. The programs will accomplish these goals by ensuring that mentors represent diverse disciplines needed to carry out interdisciplinary projects that will bridge career development/training with research independence for BIRCWH scholars.
• Funds Available: The NIH Office of Research on Women's Health and its cosponsors intend to commit approximately $5 million in total costs [Direct plus Facilities and Administrative (F&A) costs] for this initiative in FY 2007.
• Awards: Funding of up to 10 new and competing continuation awards is anticipated.
• Mechanism of Support: This funding opportunity will use the NIH Institutional Mentored Research Career Development Program Award (K12) mechanism.
• Eligible Organizations: Domestic for profit or non-profit public or private institutions such as universities, colleges, hospitals, and laboratories. Foreign institutions are not eligible to apply.
• Eligible Principal Investigators: Eligible principal investigators should have a strong track record in research, research training, and administration that demonstrates the skills, knowledge, and experience necessary to carry out the proposed research in the area of women’s health.
• Number of Applications: Eligible institutions may submit one application.
• Application Materials: See Section IV.1 for application materials.
• Telecommunications for the hearing impaired is 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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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

The ORWH and its cosponsors invite institutional career development award applications for Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Career Development Programs, hereafter termed "Programs." Programs will support research career development of junior faculty members, known as BIRCWH Scholars, who have recently completed clinical training or postdoctoral fellowships, and who will be engaged in interdisciplinary basic, translational, behavioral, clinical, and/or health services research relevant to women's health or sex/gender factors.

The goal of this initiative is to increase the number and skills of investigators through a mentored research and career development experience leading to an independent interdisciplinary scientific career that will benefit the health of women, including research on sex/gender similarities or differences in biology, health or disease. Programs will accomplish these goals by ensuring that mentors represent diverse disciplines needed to carry out interdisciplinary projects that will bridge training with research independence for BIRCWH scholars.

Programs must ensure that research projects are interdisciplinary in nature. With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary collaborative approach. Advances in our understanding of sex and gender factors in health and disease can be enhanced through scientific progress across biological, physical and social science disciplines. Interdisciplinary approaches can integrate knowledge from multiple perspectives, resulting in more complex definition of underlying common normal or pathologic processes. Collaborations among research scientists in academia, private industry, and federal settings, could also provide access to the latest scientific tools and technologies for women’s health and sex/gender research.

Research integrating knowledge from disparate sources and research teams with multiple areas of scientific expertise (for example, physicians, dentists, nurses, pharmacologists, epidemiologists, biotechnologists, social scientists, chemists, physicists, bioengineers and geneticists) are needed to advance women’s health. Interdisciplinary research can facilitate the integration and synergy of basic science, clinical research, translational research, population studies, behavioral and social research, and outcomes research. An additional focus on bioengineering and biomedical informatics, genomics, proteomics, imaging, and metabolomics is increasingly relevant to research on women s health and sex/gender factors.

The NIH Institutes and Centers support biomedical and behavioral research and research training. The Agency for Healthcare Research and Quality (AHRQ) supports health services research and research training. The cosponsors are partnering with ORWH to support the career development of researchers in women's health within their respective missions. BIRCWH awards will be administered by the National Institute of Child Health and Human Development (NICHD).

Background

This initiative addresses a continued need for support of interdisciplinary research in women's health. With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary, collaborative approach. In the "Agenda for Research on Women's Health for the 21st Century, A Report of the Task Force on the NIH Women's Health Research Agenda for the 21st Century," Volume 2, pp. 187-198, Career Issues for Women Scientists, a need was identified for expanded support for interdisciplinary research bridging completion of training with an independent career in research addressing women's health. Also, the report by the Institute of Medicine, "Exploring the Biological Contributions to Human Health: Does Sex Matter?" encouraged interdisciplinary research in sex differences. In addition, a recent National Academy of Science Panel expressed concern at the prolonged time needed to achieve research independence (R01) for Ph.D.s and M.D.s, ages 42 and 44, respectively. This RFA will provide opportunities for a mentored career development experience that would otherwise not be available to help in bridging the transition to research independence for junior faculty researchers who are conducting interdisciplinary research in women's health.

Investigators with established programs covering interdisciplinary basic, translational, behavioral, clinical and health services research in the Principal Investigator's ("sponsoring") and collaborating departments, centers, or institutes, should form an inter-professional, intellectual and technical research base for mentoring BIRCWH Scholars. Mentors from collaborating departments are encouraged to provide needed expertise and resources, as long as the emphasis of BIRCWH scholars' projects is on research relevant to women's health and is responsive to the research scope identified in this RFA.

Projects may be from a variety of research areas and cut across the boundaries of multiple disciplines but must be within the biomedical and behavioral purview of NIH and/or the health services research purview of AHRQ. Program grant awards resulting from this RFA will meet the specified needs by providing clinical, health or life sciences, or public health departments, centers, and institutes, both developing and established, an opportunity to build a national capacity for junior investigators in interdisciplinary women's health research, including research on sex/gender differences, as well as research on factors that contribute to disparities in health status or health outcomes for different populations of women.

Research Scope

A number of research priority areas have been identified by the ORWH and cosponsors as current major research goals, based in part on the "Agenda for Research for Women's Health for the 21st Century" cited above. These priority research areas are updated annually by ORWH and representatives from the NIH Institutes and Centers. The programs may have one or more than one research theme, focus or emphasis, but the research activities must be responsive to this RFA.

The ORWH and representatives from the NIH Institutes and Centers have identified:

I. Overarching Themes for Research on Women’s Health

Four overarching themes are important to consider when planning, designing, implementing, and interpreting the results of research addressing women's health.

1) Lifespan: The health of girls and women is affected by developmental, physiological, and psychological age. Women s lives are marked by a continuum from intrauterine life to the elderly years: infancy, childhood and adolescence, menarche, reproductive life, the menopausal transition, postmenopausal years, the elderly, and frail elderly. Many women’s lives and health status are influenced by factors such as work inside and outside the home, care-giving such as childcare and elder care responsibilities, reproductive status, marital status, and chronic illness. Each of these may influence health, disease, treatment choices, and response to therapy. Researchers should consider these variables in designing studies related to women’s health.

2) Gender Determinants: Women are characterized by both sex and gender as highlighted in the Agenda for Research in Women’s Health for the 21st Century and the Institute of Medicine report, entitled Exploring the Biological Contributions to Human Health: Does Sex Matter? In this context, the term sex refers to being male or female according to reproductive organs and functions assigned by chromosomal complement. Sex factors that contribute to the biological differences include chromosomes, reproduction, and hormones. Gender refers to socially defined and derived expectations and roles rooted in biology and shaped by environment and experience. Gender and sex are important considerations in most areas of research, including psychological, social, and behavioral studies. Consideration of these variables is critical to the accurate interpretation and validation of research affecting women s health. Moreover, these variables determine how similar or different health or disease processes may be among women or between men and women.

3) Health Disparities/Differences and Diversity: Women are disproportionately affected by some conditions and diseases in terms of incidence, diagnosis, course, and response to treatment. Some populations of women may be at higher risk for adverse disease outcomes because of factors such as: biology, genes, culture, education, access to care, quality of care, and access to opportunities for inclusion as research subjects in clinical trials and studies. Thus, clinical research should include, but not be limited to, population-specific characteristics such as cultural diversity, race/ethnicity, immigrant status, rural or inner city residency status, effects of poverty or low socioeconomic status, sexual orientation, and physical or mental disabilities.

4) Interdisciplinary Research: With increasing understanding of the inter-relatedness and complexity of disease, the nature of scientific investigation is shifting to an interdisciplinary collaborative approach. Advances in women’s health can be better achieved by promoting partnerships across disciplines. Interdisciplinary approaches can integrate knowledge from multiple specialties, thus defining underlying common pathologic processes. Collaborations among researchers in academia, private industry, and federal settings, could provide access to the latest scientific tools and technologies for women’s health research.

II. Areas of Research Interest

Basic, clinical and translational research should be considered in addressing priority areas in women s health research. Examples may include, but are not limited to:

Diseases and Conditions that affect Women: Investigate the pathogenesis and develop preventive and therapeutic interventions for acute and chronic diseases and disorders that affect women including, but not limited to, metabolic, inflammatory, endocrine, autoimmune, gastrointestinal, liver, urologic, ophthalmic, oral, reproductive, musculoskeletal, neurological, psychiatric, and cardiovascular diseases.

Methodological Advances: Develop clinical trial methodology, including novel recruitment strategies and statistical analysis methodology that addresses ethical and study design issues specific to studies of women. Develop new methodologies for animal model studies of diseases and normal development of women, including use of female animals. Methodological studies related to the conceptualization, distinction and detection of sex and gender differences in basic and clinical biomedical research.

Education and Career Development of Women in Science: Identify and explore factors that affect the selection and advancement of women s careers in biomedical sciences; implement novel education programs directed at girls and women; and promote unique programs for addressing impediments to the advancement and effective mentoring of women to senior positions in science.

Quality of Life: Elucidate the unique sex and gender factors affecting women’s quality of life. Develop approaches to management of disease and promotion of wellness that are directed at women and their unique issues.

Trans NIH Collaboration: Foster special trans-NIH research partnerships and collaborations in all areas of research and career development related to women’s health.

III. Special Emphasis Areas

The NIH is especially interested in fostering research in women’s health in the high priority areas of prevention and treatment, and the biological and behavioral basis of sex and gender differences.

Prevention and Treatment: Increased investigation into methods to prevent conditions and diseases, or to better treat them, can result in significant improvements in the quality and length of women’s lives. Prevention research spans the continuum from the most basic biological studies to understanding the basis and effects of risk behaviors across the lifespan and the interventions to change them, including a focus on wellness and healthy behaviors. Examples of needed prevention and treatment research studies in women’s health include, but are not limited to: Research to identify and validate biomarkers, including genetic polymorphisms, of disease risk, pathogenesis, progression, and their applications to disease prevention, early detection and treatment, including the development of novel tools; Studies of the impact on health of diet, nutrition, hormones, exercise, weight patterns, toxin exposures, obesity, eating disorders, sex practices, tobacco, alcohol and drug use or abuse, occupation, violence or trauma; Studies of the factors that are involved in disease initiation and progression, both biologic and behavioral, in order to develop effective preventive and treatment strategies; Development, testing, and validation of preventive, early detection, and treatment strategies for conditions and diseases including, but not limited to: sexually transmitted diseases, cancer, coronary artery disease, stroke, obesity, diabetes, musculoskeletal disorders, pain syndromes, addictions, and chronic multi-systemic diseases; Studies of the effect of biological, behavioral, cultural, social, economic, and environmental factors on susceptibility to, or protection from, disease and response to treatment.

Biological and Behavioral Basis of Sex and Gender Differences: While there has been much research to identify the function of cellular pathways and genes, research on the effects of sex as a modifier of cellular and gene function is under-investigated. Systemic and cellular modeling of the influence of sex differences in biological pathways and systems is needed, including, but not limited to: Determination of sex differences that may modify the role of known cellular pathways and gene defects in disease Sex and gender differences in prevention, pathogenesis, course, response to treatment, and prevention, using basic, translational, behavioral, and clinical research approaches; Mechanism of sex effects on gene expression and cellular and signaling pathways in healthy women, including the impact of puberty, the menstrual cycle, pregnancy, and menopause; Genetic, molecular and cellular basis of action of pharmacologic agents in women, including differential effects between males and females; Development of novel methods of analysis to assist in discerning impact of sex in mechanisms of disease initiation, course, and response to treatment or other interventions; Effect of biologic and behavioral sex and gender difference on quality of life and quality of care. Nature of the research opportunity

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the Institutional Mentored Research Scientist Development Program (K12) award mechanism(s).

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

• ORWH and cosponsors intend to commit approximately $5 million in total costs [direct plus facilities and administrative (F&A) costs] for this initiative in FY2007;
• Up to 10 new and/or competing continuation awards are anticipated;
• Awards maybe up to $460,000 in direct costs [up to $92,000 for administrative direct costs and up to $368,000 for scholar direct costs] annually per Program;
• The average direct costs per award in previous years has been $460,000; and
• September 1, 2007 is the earliest anticipated start date for new and competitively renewed programs. Project periods may be up to 5 years.

The participating IC(s) ORWH and cosponsors intends to commit approximately $ 5million dollars in FY 2007 to fund up to 10 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $460,000 dollars per year.

Because the nature and scope of the proposed research 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic Institutions

Applicant institutions must have the clinical specialties and subspecialties and the clinical and research facilities sufficient to meet the purposes of the BIRCWH program, namely, to bridge clinical or postdoctoral training with a career development program in interdisciplinary basic, translational, behavioral, clinical and/or health services research relevant to women's health. The RFA is open to new and competing continuation BIRCWH programs. A list of institutions that have received a BIRCWH award may be obtained at http://orwh.od.nih.gov/interdisciplinary/bircwhmenu.html.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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 support.

2. Cost Sharing or Matching
Not Applicable

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Special Programmatic Requirements

BIRCWH Scholars: The Scholar position is a junior faculty appointment, not a fellowship. At the time of the award, candidates for support as BIRCWH Scholars must: (1) have a clinical doctorate or Ph.D. degree or its equivalent; (2) have completed any postgraduate training normally expected for a faculty appointment in their field (including clinical or postdoctoral fellowship training, or residency if they have chosen not to subspecialize); (3) identify mentors with extensive research experience; (4) be able to spend at least 75 percent of full-time professional effort conducting research and research career development activities; (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 (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.

Generally, new scholar appointments will have start dates of July 1 and January 1. Scholar appointments should be based on the recommendation of the Advisory Committee. Support is in the form of a minimum of two consecutive 12-month appointments, renewable in annual increments for up to five years total, and is contingent upon satisfactory progress as reported to the Advisory Committee and to the NIH in the annual progress report of the Program. At least 75 percent of the BIRCWH Scholars' full-time effort must be devoted to the research program of the award. BIRCWH Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. Programs are encouraged to recruit members of underrepresented racial and ethnic groups, and candidates with disabilities. Scholars are encouraged to apply for independent research grant support during the period of K12 support, and are allowed concurrent salary support only while in the last two years when in compliance with NIH Policy Notice, NOT-OD-04-007 which can be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.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. At the time of their application, 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 NIH in the annual progress report of the Program.

2. Program Composition: Applicants must describe or propose an interdisciplinary 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 members of underrepresented racial and ethnic groups, and candidates with disabilities, in biomedical careers. The Program must have a strong research base, comprising the investigations of established scientists who will provide expertise, resources, and mentoring to the BIRCWH Scholars. The research base must be broad and relevant to current areas of research interest and need in women's health. The environment should be one that will stimulate and increase the interactions among disciplines, which may include basic, behavioral, clinical, social, and population sciences. Of major importance, the Program must have a scientifically sound and equitable procedure for recruiting and selecting BIRCWH 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 its goal of developing and retaining productive, independent investigators in areas of women's health concerns.

3. Principal Investigator: The Principal Investigator of a Program must be a senior faculty member such as a Dean, Department Chair, or Director of a research center or interdisciplinary institute. He/she should possess the scientific background, leadership, and administrative capabilities required to coordinate and supervise an interdisciplinary research and development program of this scope. The PI of the application may serve as the Program Director (PD), with responsibility for the day-to-day operations of the Program. Alternatively, the application may designate a co-investigator other than the PI to serve as Program Director. In that case, the Program Director should be an experienced investigator and have experience and qualifications complementing those of the PI, and the division of responsibility between the two individuals should be clearly described in the application. A PI is allowed to submit one application under this initiative.

4. Career Development Program: The K12 award provides up to five years of funding for the Program. The Program will support BIRCWH Scholars for periods of two to five years consisting of consecutive 12-month appointments. At least 75 percent of the BIRCWH Scholar's full-time professional effort must be devoted to the K12 program. The remainder of the BIRCWH Scholar's time may be devoted to developing other clinical or academic pursuits consonant with the objectives of the award.

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 programs. It may include mentors. The two major functions of the committee are to evaluate: 1) applications from BIRCWH Scholar candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations to the Principal Investigator as to BIRCWH 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 may be reviewed as part of a competing or non-competing 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 BIRCWH 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 must provide a guarantee of at least 75 percent protected time for the BIRCWH Scholars for research. As part of its commitment to support women's health research, the applicant institution may choose internally to designate the Program as a Center, supported in part by the K12 Program award. Applicant institutions must demonstrate commitment to recruitment and retention of members of underrepresented racial and ethnic groups, and candidates with disabilities.

7. Mentors: BIRCWH Scholars should be assigned at least two mentors for interdisciplinary research and career development. Additional mentors may be provided as deemed necessary to conduct proposed research project(s). Mentors must be currently funded and recognized as independent investigators who are actively involved in basic, translational, clinical, and/or health services research relevant to this initiative, and who have a successful record of providing research training of a type expected in this Program. Assigned mentors will provide guidance for the development of each BIRCWH Scholar assigned to the program. Mentors must be committed to continue their involvement throughout the BIRCWH Scholar's total period of development under the award.

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 BIRCWH 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. Such a resource would provide skilled technical services to complement and extend the capabilities of the mentors to promote the career development of the BIRCWH 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 four BIRCWH Scholars' projects. The salaries and 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 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 on the basis of recommendations from the Advisory Committee.

9. Evaluation and Tracking Component: The applicant should describe a strong evaluation and tracking component that will review the effectiveness of all aspects of the program and a system for tracking graduates throughout their career to determine the success rate of applying for an obtaining federal and non-federal research grant support. This should include enrollment and appointment information (diversity of backgrounds, disciplines and specialties) and outcome measures (academic placement, NIH funding, interdisciplinary (clinical, basic science, translational, or health services research), etc. For purposes of evaluating the impact of interdisciplinary research career development programs, awardees must agree to provide ORWH 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 ongoing evaluation of the Program in terms of recruitment and retention goals, including members of underrepresented ethnic and racial groups, and individuals with disabilities, completion success, overall outcome, the curriculum, and program staff.

10. Recruitment Plan: Applicants must submit a recruitment plan that includes a scheme for: (1) recruiting BIRCWH scholars both inside their institution and nationally and (2) recruiting under-served and under-represented racial and ethnic populations and individuals with disabilities.

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 on line 2 of the face page of the application form and the YES box must be checked.

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(s): August 14, 2006
Application Receipt Date(s): September 14, 2006
Peer Review Date(s): January/February 2007
Council Review Date(s): June 2007
Earliest Anticipated Start Date: September 1, 2007

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 at the beginning of this document.

The letter of intent should be sent to:

Charisee Lamar, Ph.D., M.P.H., R.R.T.
Program Director, Interdisciplinary Research and Reproductive Biology Research Programs
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-6515
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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).

Using the RFA Label: The RFA label available in the PHS 398 application instructions 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: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the (cosponsors). Incomplete and 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

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 http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation 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

Supplemental Instructions:

1) Begin with an overview of the proposed program including its interdisciplinary character: 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 research priorities identified by the NIH, Office of Research on Women's Health to support the career development of junior faculty who are conducting interdisciplinary research in women's health.

2) The Scholar Candidates: Describe the criteria to be used for candidate evaluation for selection as BIRCWH Scholars. Describe plans to recruit candidates both locally and nationally, including, racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences, and candidates with disabilities.

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 program award may include 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 Program award. Other candidates may need to receive concurrent or simultaneous didactic training and a mentored research experience. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates, and should distinguish the plan from fellowship training.

4) Advisory Committee: Describe the composition of the Advisory Committee and the role of internal members, and describe 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: 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, clinical, and/or health services research relevant to women's health. Include the specifics of institutional support. There is no dollar requirement, but significant commitment will be considered strength. Letters from faculty mentors are not required unless they are collaborators from other institutions.

Collaborations between research-intensive and less-research-intensive institutions, and/or minority institutions, will be considered 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 BIRCWH Scholar's research experience in the Program. The research experiences may include interdisciplinary basic, behavioral, translational, clinical, and/or health services research approaches to biomedical or behavioral problems in women's health. Lengthy, detailed protocols or plans for specific experiments should not be included.

7) Mentors: 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. 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 currently funded research for each proposed mentor.

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.

8) 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, as well as the amount and nature of faculty participation. No award will be made if an application lacks this component.

9) Current BIRCWH Programs: For eligible BIRCWH 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 baseline level of entry and career outcomes of all Scholars who have entered your program over the course of the award. The summary should contain information on their research skills acquired, promotions, publications, number of research grant applications submitted (NIH, industry, other), number of research grants funded, honors and awards, and other relevant professional activities. Include measures of success consistent with the nature and duration of the training period, and any additional information helpful in evaluating the impact of your Program.

10) Other Existing K12 Programs: Those institutions with a current Women's Reproductive Health Research Career Development (WRHR) Program or other K12 programs such as the National Multidisciplinary Clinical Research Career Development Program must provide strong evidence that the addition of a BIRCWH Program will provide career development training that is separate and distinct from that offered by their existing K12s, including avoidance of overlap in terms of research topics, budget and related Issues.

Allowable Costs

The Program structure may have these elements: Administration Costs (including the Resource Laboratory), Scholar Costs, and Facilities and Administrative (F&A) Costs.

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

Resource Laboratory: Budgets may include salaries and fringe benefits for a Resource Laboratory Director (up to 50 percent), other technical staff, supplies, animals, equipment purchase and maintenance.

The sum of the budgets for Administration and a Resource Laboratory may not exceed $100,000 total costs per year.

b) Scholar Costs: As part of the Scholars' costs, an application must request a minimum of four BIRCWH Scholar positions, at least half of which must be for individuals with a clinical doctoral degree as defined above in Section A. Applications requesting more than four positions may designate up to half the total number for candidates with a non-clinical doctoral degree. Generally, new scholar appointments will have start dates of July 1 and January 1. Scholar appointments should be based on the recommendation of the Advisory Committee.

This initiative will provide support for each BIRCWH Scholar position for up to $100,000 total costs per year.

Salary: 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 from non-federal sources; 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 BIRCWH 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.

Research and Career Development Support: Within each BIRCWH Scholar's total award, up to $25,000 annually may be requested for research and career development support, which may include the following expenses: (1) tuition and fees related to career development; (2) research expenses, such as supplies, equipment, and technical personnel; (3) travel to one training or scientific meeting per year, in addition to the annual NIH meeting for Scholars; (4) statistical services including personnel and computer time; and other project infrastructure including relevant data sets. These research and development costs must be specifically documented for each scholar candidate and must be 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.

Scholars' Other Source of Support: BIRCWH Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. Scholars are encouraged to apply for independent research grant support during the period of K12 support, and are allowed concurrent salary support only while in the last two years when in compliance with NIH Policy Notice, NOT-OD-04-007 which can be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html.

c) Facilities and Administrative costs: Facilities and Administrative (formerly, indirect) costs will be reimbursed at eight percent of modified total direct costs, or at the actual Facilities and Administrative cost rate, whichever is less.

Non-Allowed Costs

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 and Program Director, except for travel to the annual BIRCWH meeting held at NIH, or mentors to scientific meetings; costs of clinical care; and alterations and renovations.

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:

a) 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.

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

c) 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.

Plan for Sharing Research Data

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance of program priorities

2. Review and Selection Process

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 Center for Scientific Review (CSR) in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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

The goal of this career development program is to bridge the transition to research independence for junior faculty who are conducting interdisciplinary research in women's health, including sex and gender differences. 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:

1. The probable impact of the Program award on enhancing the capacity of the grantee institution to develop well-qualified new investigators, thus enhancing interdisciplinary women's health research locally and nationally. This includes the scientific and administrative experience of the Principal Investigator/Program Director in preparing interdisciplinary clinical, basic, translational, and/or health services research investigators for independent research careers.

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

3. Quality of the plan to recruit scholars from within the applicant’s institution and nationally.

4. Quality of the plan to enhance diversity by recruiting individuals from racial and ethnic groups underrepresented in research, and individuals with disabilities.

4. For current BIRCWH programs submitting a competing continuation application, the quality, overall impact, and effectiveness of their program in developing the careers of junior faculty of all levels who are conducting research in women's health and the effectiveness in producing independent women's health investigators.

5. For institutions with a current WRHR Program or other K12 programs, the effectiveness of the plan to keep the career development activities of the proposed BIRCWH Program distinct from that offered by the other K12 Programs, including avoidance of overlap in terms of scholar research topics and justification for the need for the BIRCWH.

Candidates:

1. Evidence of a plan to recruit scholars from within the applicant’s institution and nationally, who could benefit from receiving career development support in the area of women’s health.

2. Adequacy of plans to recruit, identify, and select candidates with a commitment to research relevant to women's health and the potential to develop as independent researchers.

3. Evidence of a plan to recruit individuals from racial and ethnic groups underrepresented in research and individuals with disabilities.

Career Development Plan:

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

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

3. Consistency of the career development plan with prospective candidates' career goals and the interdisciplinary aims of the RFA.

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

5. Quality of the training and mentoring in grantsmanship/obtaining research funds.

6. Quality of the training grant to address the needs of scholars of different levels

7. Quality of the plan to ensure at least 75% protected time for scholars to conduct proposed interdisciplinary research related to women’s health.

Research Plan:

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

2. Degree to which the plan ensures interdisciplinary research training in women's health that cuts across multiple disciplines or specialties at the institution.

Mentors:

1. Appropriateness of the faculty mentors' qualifications in the areas of research relevant to this RFA.

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

3. Previous experience of the mentors in fostering the development of researchers.

4. Evidence of recognition and active involvement in research relevant to this RFA initiative.

Resource Laboratory, if applicable:

1. 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 BIRCWH Scholars.

Environment:

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

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

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

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

2.A. Additional Review Criteria:

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

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the adequacy of the proposed protection will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

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

Special Administrative Issues

1. Special Leave: A candidate appointed to this program career award may engage in research experiences at another institution, including a foreign site, if these experiences are directly related to the purpose of the award and within the scope of the scholar's mentoring plan. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the awarding component is required. To obtain prior approval, the Principal Investigator must submit a letter describing the plan, countersigned by the appropriate institutional official, to the awarding component. 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 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 Program award upon determination that the purpose or terms of the award are not being fulfilled. For a Program co-funded by AHRQ, any such determination would encompass the recommendation of the Administrator of AHRQ. In the event 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 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 the awarding component under the following conditions:

a) The current Principal Investigator or the awardee institution has submitted a written request to Staff of the awarding component 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: 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 the awarding component 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.

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).

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Special Reporting Requirements

1. Progress Reports: An Annual Progress Report is required. This report should provide information about changes in the Program, a summary report of the evaluation of the Advisory Committee, a description of the efforts to recruit individuals from diverse populations, including individuals from racial and ethnic groups underrepresented in biomedical research, and individuals with disabilities. Report the research and career progress of each BIRCWH Scholar. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the Program.

Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. Since the Form PHS 2590 does not apply easily to the K12 grant, adapt the application for continuation to contain the following information:

• Appropriate face page (Form Page 1) as instructed in the Form PHS 2590.
• A budget page (Form Page 2) that provides the salary and fringe benefits for each candidate or Scholar by name or by position if no individual is filling the position at the time of the application. Provide all other budgetary information (e.g., supplies, travel, technical assistance) by Scholar name or by the position broken out specifically for each candidate and/or Scholar up to the $25,000 limit.
• A brief description of the Objectives and Goals of the Program
• A brief summary listing by name those faculty, mentors and Advisory Committee members who have left the Program and those new individuals who have been added or are taking their places. Include for each person their degree and department affiliation (or equivalent).
• Biographical sketches of 1) new mentors, 3) new Advisory Committee Members , and 4) new scholars.
• Progress of BIRCWH Scholars: For each Scholar, provide the start date (month/year) of the appointment to the Program and the cumulative number of years supported by the K12 grant; the name of the mentors; and a brief paragraph for each Scholar describing the basic laboratory and/or clinical research and didactic training experiences completed and ongoing. The individual reports should include a list of publications for the Scholar resulting from their work in the program and any pending or received research support in which they are the Principal Investigator or subproject Director.
• A report from the Advisory Committee that is separately attached summarizing the actions of the Advisory Committee during the last year, evaluating the performance of the Program in meeting its objectives and the intent of the ORWH, evaluating the effectiveness of recruitment strategies and providing recommendations for improving the Program (e.g., new mentors, changes in recruitment strategies etc.).
• Other information that, from year to year, may be requested by the awarding component to ensure that the grant is achieving the goals of the Program.

2. Evaluation/Tracking Scholars: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this Program. Accordingly, recipients (PIs and Scholars) are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of the 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.

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

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:

Charisee Lamar, Ph.D., M.P.H., R.R.T.
Program Director, Interdisciplinary Research and Reproductive Biology Research Programs
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard
Room 8B01, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 496-6515
Email: [email protected]

2. Peer Review Contacts:

Bob Weller, Ph.D., Chief
Health of the Population (HOP) Integrated Review Group
Center for Scientific Review, NIH
6701 Rockledge Drive, Room 3136, MSC 7770
Bethesda, MD 20892 (20817 for overnight mail)
Telephone: 301-435-0694
Email: [email protected]

3. Financial or Grants Management Contacts:

Cecilia Bruce
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd - Room 8A17L
Rockville, Maryland 20852
Telephone: (301) 496-1304
Fax: (301) 480-4782
E-mail: [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).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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. 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 PA 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 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.

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