Building Interdisciplinary Research Careers in Women's Health

RFA Number: RFA-OD-05-002

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 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 Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)

Announcement Type
This is a reissue of RFA-OD-02-001 previously released on December 5, 2001.

Updates:

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.273, 93.856, 93.279, 93.849, 93.894, 93.242

Key Dates

Release Date: November 24, 2004
Letters of Intent Receipt Date(s): January 22, 2005
Application Receipt Date(s): February 23, 2005
Peer Review Date(s): June/July 2005
Council Review Date(s): September 2005
Earliest Anticipated Start Date: September 30, 2005
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: February 24, 2005

Due Dates for E.O. 12372
Not Applicable.

Executive Summary

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 research career development of junior faculty members, known as Interdisciplinary Women's Health Research (IWHR) Scholars, who have recently completed clinical training or postdoctoral fellowships, and who are commencing basic, translational, behavioral, clinical and/or health services research relevant to women's health.

The goal of this initiative is to promote the performance of interdisciplinary research and transfer of findings that will benefit the health of women, including sex/gender similarities or differences in biology, health or disease. The programs will accomplish these goals by bridging advanced training with research independence, as well as bridging scientific disciplines or areas of interest. This will increase the number and skills of investigators at awardee institutions through a mentored research and career development experience leading to an independent interdisciplinary scientific career addressing women's health.

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.

Telecommunications for the hearing impaired: 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
    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
      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
    3. Merit Review Criteria
      A. Additional Review Criteria
      B. Additional Review Considerations
      C. Sharing Research Data
      D. Sharing Research Resources

  Section VI. Award Administration Information
    1. Award Notices
    2. Administrative Requirements
     A. Cooperative Agreement Terms and Conditions of Award
        1. Principal Investigator Rights and Responsibilities
        2. NIH Responsibilities
        3. Collaborative Responsibilities
        4. Arbitration Process
    3. Award Criteria
    4. 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 Interdisciplinary Women's Health Research (IWHR) Scholars, who have recently completed clinical training or postdoctoral fellowships, and who are commencing basic, translational, behavioral, clinical and/or health services research relevant to women's health.

The goal of this initiative is to promote the performance of interdisciplinary research and transfer of findings that will benefit the health of women, including sex/gender similarities or differences in biology, health or disease. The programs will accomplish these goals by bridging advanced training with research independence, as well as bridging scientific disciplines or areas of interest. This will increase the number and skills of investigators at awardee institutions through a mentored research and career development experience leading to an independent interdisciplinary scientific career addressing women's health.

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.

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 research programs covering interdisciplinary basic, translational, behavioral, clinical and health services in the Principal Investigator's ("sponsoring") and collaborating departments, centers, or institutes, should form an inter-professional, intellectual and technical research base for mentoring IWHR Scholars. Mentors from collaborating departments are encouraged to provide needed expertise and resources, as long as the emphasis of IWHR 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) Interdisciplinary Research: Advances in women's health can be better achieved by promoting partnerships in cross-disciplinary research from basic to clinical and translational research that involves collaborative interactions with researchers in all areas of academic, private industry, and federal settings, and provides access to the latest scientific tools and technologies. Research from many perspectives is needed in women's health, including integration of knowledge from disparate sources as well as teams with multiple areas of scientific expertise. Interdisciplinary research can facilitate the integration of basic science, clinical research and translational research, population studies, behavioral and social research, and outcomes research. An additional focus on bioengineering and biomedical informatics, genomics, proteonomics, imaging, industry, and metabolomics is increasingly relevant to research on women's health.

2) Sex/Gender Determinants: Women are characterized by both sex and gender as highlighted in the ORWH 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? Sex factors that contribute to the biological differences include chromosomes, reproduction, and hormones. The effects of gender on psychological, social, and behavioral perspectives are important considerations in most areas of research. 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 between women and men.

3) 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 roles such as child care and elder care responsibilities, reproductive influences, 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.

4) 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 culture, education, access to care, quality of care, and 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, racial and ethnic minority status, immigrant status, rural or inner city residency status, effects of poverty or low socioeconomic status, sexual orientation, and physical or mental disabilities.

II. Areas of Interest in Women's Health

Within the research continuum, studies that encourage the adoption of basic, clinical and translational research findings should emphasize important questions that still remain about women's health. This would include fostering more research to identify the best methods to move knowledge gained from basic science research into clinical research and practice in order to improve clinical outcomes. Studies that help to determine the best clinical practices in the care of women, or of men, should be emphasized in order to increase the clinical knowledge base, and the ability of women to participate in the management of their health. In addition, studies that enhance the adoption of clinical research results by healthcare providers and public policy makers are further steps in advancing women's health research. The value of conveying clinical observations to basic scientists is important. Through a continuum of interdisciplinary collaborations, research can better contribute to the development and evaluation of effective strategies to improve the health-related quality of care and quality of life for women. Basic, clinical and translational research should be considered in addressing priority areas in women's health research.

Some examples may include, but are not limited to:

1) Studies of chromosomal, genetic, gonadal and phenotypic sex in in vitro or animal models.

2) Etiologic mechanisms to elucidate sex differences in cellular, tissue/organ, physiological and/or immune responses to environmental and infectious agents.

3) Cellular and molecular studies of the mechanism of action and effects of complementary and alternative medicines and dietary supplements in the treatment of conditions or diseases that differentially affect women.

4) Studies of the pathogenesis of diseases that differentially affect women, including those affecting behavioral pathways and the endocrine, musculoskeletal, autoimmune, urologic, cardiovascular, ophthalmic, and neurobiological systems.

5) Systemic and cellular modeling of biological pathways and systems related to women's health.

6) Clinical trial methodology, including ethical issues and study design specific to women, novel recruitment strategies, and novel statistical analysis methodology.

7) Mental health studies, including physical and physiological stressors, incidence and severity of addictive, mood, cognitive, and anxiety disorders, behavioral studies on the effects of care-giving on the health of the caregiver and multiple/competing societal role.

8) Studies on new agents for management of menopausal symptoms.

9) Prevalence and validation of sex differences in the diagnosis and treatment of disorders and diseases differentially affecting men and women.

10) Treatments and other interventions for specific diseases that have enhanced clinical presentation in women including, but not limited to diseases of the metabolic, endocrine, autoimmune, urologic, ophthalmic, oral, reproductive, musculoskeletal, neurological and cardiovascular systems.

11) Special trans-NIH research collaborations in areas such as Chronic Fatigue Syndrome and uterine fibroids.

III. Special Emphasis Areas for Women's Health Research

The following are areas of special emphasis for fostering research in women's health and in sex/gender determinants that will address current or emerging gaps in our current knowledge. The ORWH is especially interested in fostering research in women's health in the high priority areas of prevention and genetics/pharmacogenomics.

Prevention and Treatment

Increased knowledge of how 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.

Examples of needed prevention research studies in women's health include, but are not limited to:

1) Research to identify and validate biomarkers of disease pathogenesis and risk and their applications to disease prevention, early detection and treatment, including the development of novel tools.

2) Studies of the impact of diet, nutrition, hormones, exercise, weight patterns, tobacco, alcohol and drug abuse, and violence on health.

3) Research on reproduction, from menarche, including pregnancy to the menopausal transition, with regard to the susceptibility to, and protection from, diseases and conditions.

4) Studies of the factors, which are involved in disease initiation and progression in order to develop effective preventive and curative strategies.

5) Development, testing, and validation of preventive and curative strategies for conditions and diseases, including but not limited to: sexually transmitted diseases, cancer, coronary artery disease, stroke, obesity, musculoskeletal disorders, addictions, and chronic multi-system diseases.

6) Studies of the effect of biological, behavioral, cultural, social, economic, and environmental factors on susceptibility to, or protection from, disease.

Genetics/Pharmacogenomics

The sequencing of the human genome has provided a resource for research on disease incidence, pathogenesis, and response to treatments. The role of genetic polymorphisms and pharmacogenomics holds promise as exhibited by recent successes for predicting response of individuals to a range of current treatments. Emphasis in this emerging area is needed on women and the diseases that disproportionately affect them, as well as on determining if and why there may be sex differences.

For example:

1) Particular emphasis on sex chromosomal differences; genomic areas known to be involved in diseases that disproportionately affect women; the effects of aging (or different ages) on gene expression; and the relationship of these findings to genetic polymorphisms.

2) Genetic, molecular and cellular bases for action of pharmacologic agents known to have different effects in women. Examples include the scientific basis for drugs, environmental exposures, devices, and biologics targeted at a particular sex for common diseases; impact of lifespan, developmental phase, and pregnancy in pharmacokinetics, pharmacodynamics, drug efficacy and adverse effects; development of novel methods of analysis; and the application of pharmacogenomics to clinical care.

3) Emphasis on critical windows of susceptibility; the interaction of genetic polymorphisms with diet, drugs, or toxins on the architecture or development of reproductive or other organs; genetic, cellular, and molecular mechanisms of environmental exposures occurring prenatally, during puberty or pregnancy and beyond.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the 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 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 FY2005 to support up to 10 new and/or competing continuation grants in response to this RFA . K12 awards will be for up to $500,000 total costs (direct plus F& A) per year, and will support a minimum of four IWHR scholars. F & A costs for these awards are limited to eight percent of modified total direct costs.

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 cosponsors 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.

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:

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 in interdisciplinary basic, translational, behavioral, clinical and/or health services research relevant to women's health. Racial/ethnic minority individuals, persons with disabilities, and women are encouraged to apply as Principal Investigators. 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://www4.od.nih.gov/orwh/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 programs.

2. Cost Sharing
Not applicable.

3. Other-Special Eligibility Criteria

Special Programmatic Requirements

1. IWHR Scholars: The Scholar position is a junior faculty appointment, not a fellowship. At the time of the award, candidates for support as IWHR 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 a mentor with extensive research experience; (4) be able to spend at least of 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 (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.

Clinical doctorate degrees include, but are not limited to, the M.D., D.O., D.D.S., D.V.M., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of Naturopathy), and including the clinical Ph.D. (e.g. psychologists) as well as nurses with doctoral degrees. In addition, other clinicians holding doctoral degrees may be eligible. Completion of clinical subspecialty training is not required of candidates in general practice in their specialty; however, those who choose to subspecialize must have completed their fellowships. 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 women and minorities, 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 IWHR 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 IWHR 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.

There must be a plan for periodic research meetings and networking for all Scholars and mentors. The ORWH will hold an annual meeting for Scholars and relevant program personnel at the NIH.

3. Principal Investigator: The Principal Investigator (PI) of a Program must be a senior faculty member such as 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 a multidisciplinary research and development program of this scope. The PI of the application may serve as the Program Director, 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.

4. Career Development Program: The K12 award provides five years of funding for the Program. The Program will support IWHR 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 -- a basic and/or clinical science-training component and an intensive research experience under the general guidance of a qualified mentor. At least 75 percent of the IWHR Scholar's full-time professional effort must be devoted to the K12 program per se. The remainder of the recipient IWHR 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 programs. It may include mentors. The two major functions of the committee are to evaluate: 1) applications from IWHR Scholar candidates, and 2) the overall conduct of the Program. Specifically, the committee makes recommendations to the Principal Investigator as to IWHR 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 IWHR 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 IWHR 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 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 IWHR 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, clinical, and/or health services 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 IWHR Scholar assigned to the program. The mentor must be committed to continue this involvement throughout the IWHR 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 IWHR 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 IWHR 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 IWHR 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 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, clinical vs. basic science research), etc. For purposes of evaluating the impact of 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 for women and minorities, 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 IWHR scholars both inside their institution and nationally and (2) recruiting under-served and under-represented minority and ethnic populations.

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. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001; 9/2004 version after May 10) 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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com. 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
Applications must be received on or before the date described below (Section IV.3.A).

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: January 22, 2005
Application Receipt Date(s): February 23, 2005
Peer Review Date: June/July 2005
Council Review Date: September 2005
Earliest Anticipated Start Date: September 30, 2005

3.A.1. Letter of Intent

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

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:

Joan Davis, M.D., M.P.H.
Program Director, Multidisciplinary 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
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 496-6515
Email: jd372m@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

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 listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the cosponsors. Incomplete and/or non-responsive applications will not be reviewed.

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

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All 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 (see also Section VI.3. Award Criteria).

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 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 IWHR Scholars. Describe plans to recruit candidates both locally and nationally, including those from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences.

(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, 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: 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 a 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 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 IWHR 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

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 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.

b) 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.

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.

2. As part of the Scholars' costs, an application must request a minimum of four IWHR 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 and will require submission of appointment forms (PHS 2271) with each new scholar appointment and subsequent approval by the funding component. Approval for alternate appointment dates may be given by the funding component.

a) 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 IWHR 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 IWHR 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, fees, and books 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.

c) Scholars' Other Source of Support: IWHR Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. During the period of this award, IWHR Scholars are encouraged to apply for, and may accept and hold, independent research grant support including institutional grants and industry grants.

Additionally, scholars may hold an NIH Research Project Grant in the last two years of their support (see http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html).

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, Program Director or mentors to scientific meetings; costs of clinical care; and alterations and renovations.

Other Income

Fees resulting from clinical practice, professional consultation, or other comparable activities required by the research and research-related activities of this award may not be retained by the candidate. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.

The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH, and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment.

Program personnel supported by the K12 award may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH- or AHRQ-supported research or training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be re-budgeted. An institute will give consideration to approval for use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of an NIH or AHRQ career award must receive prior written approval of the institute-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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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. Award Criteria.

Section V. Application Review Information

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

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIH Center for Scientific Review (CSR) in accordance with the review criteria stated below.

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

3. Merit Review Criteria

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 clinical, basic, 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 partnerships between research-intensive institutions and less-research-intensive institutions and/or minority institutions

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

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. Efforts to develop a recruitment plan for women and those from racial and ethnic groups underrepresented in research.

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 multidisciplinary 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

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.

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 IWHR Scholars.

Environment:

1. Applicant institution's commitment to the Program's scientific development of the IWHR Scholars, and assurances that the institution intends the Program and the supported IWHR 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 75 percent protected time for research for each IWHR Scholar.

3.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.

3.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.

3.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.

3.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/archive/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.

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 Principal Investigator 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. Award Criteria.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Once all administrative and programmatic issues have been resolved, the Notice of Grant Award will be generated via e-mail notification from the awarding component to the grantee business official (designated in Item 14 on the Application Face Page). If a grantee is not e-mail enabled, a hard copy of the Notice of Grant Award will be mailed to the business official.

2. Administrative Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

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 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 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: 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 the awarding component. 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.

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable.

3. Award Criteria

The following will be considered in making funding decisions:

4. 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: The K12 award is not subject to the streamlined non-competing application process (SNAP) or just-in-time procedures. 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. Evaluation/Tracking Scholars: In carrying out its stewardship of human resource-related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this Program. Accordingly, awardee institutions are hereby notified that IWHR 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.

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:

Joan Davis, M.D., M.P.H.
Program Director, Multidisciplinary 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: jd372m@nih.gov

2. Peer Review Contacts:

Ray Bramhall, Ph.D./Sooja K. Kim, Ph.D.
Endocrinology, Metabolism, Nutrition and Reproductive Sciences IRG
Center for Scientific Review
6701 Rockledge Drive, Room 6182, MSC 7892
Bethesda, MD 20892
Telephone: ( 910) 458-1871/(301) 435-1780
Fax: (301) 480-2065
Email: bramhalr@csr.nih.gov

3. Financial or Grants Management Contacts:

Mr. L. Rashawn Farrior
Grants Management Specialist
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone: (301) 435-7010
Email: farriorl@mail.nih.gov

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.

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/archive/archive/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.

Public 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 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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA 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.

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 web site (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 percent 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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NIH Funding Opportunities and Notices


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