WOMEN'S REPRODUCTIVE HEALTH RESEARCH CAREER DEVELOPMENT CENTERS-WRHR RELEASE DATE: April 4, 2003 RFA: HD-03-020 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) Office of Research on Women's Health (ORWH) (http://www4.od.nih.gov/orwh/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.864 LETTER OF INTENT RECEIPT DATE: June 30, 2003 APPLICATION RECEIPT DATE: July 29, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Child Health and Human Development (NICHD) and the NIH Office of Research on Women's Health (ORWH) invite institutional career award applications for Women's Reproductive Health Research Career Development Centers, hereafter termed "Centers." These awards will support research career development of obstetrician-gynecologists, to be known as Women's Reproductive Health Research (WRHR) Scholars, who have recently completed postgraduate clinical training, and who are commencing basic, translational, and/or clinical research relevant to women's health. The goal of this initiative is to promote the performance of research and transfer of findings that will benefit the health of women. The Centers will accomplish this by bridging clinical training with research independence, increasing the number and skills of obstetrician-gynecologist investigators at awardee institutions through a mentored research experience leading to an independent scientific career addressing women's reproductive health concerns. This program will result in a well-qualified cadre of academic obstetrician- gynecologist investigators who will help strengthen the research capacity in health professional institutions and meet the need for highly skilled scientists with a clinical background who can address the increasing research opportunities in women's health. RESEARCH OBJECTIVES Background This initiative addresses a continued need for expanded support for bridging clinical training with an independent career in research addressing women's health concerns. Awards resulting from this RFA would meet this specified need by providing departments of Obstetrics and Gynecology, both developing and established, an opportunity to build a national capacity for junior investigators in women's health research. One objective of this initiative is to promote the performance of research and transfer of findings that are relevant to women's reproductive health. Investigators with established research programs covering a broad range of basic and applied biomedical and biobehavioral science in the Obstetrics-Gynecology and collaborating departments will form an intellectual and technical research base for mentoring WRHR Scholars. Although mentors from collaborating departments may provide needed expertise and resources, the emphasis of the WRHR Scholars' scientific projects should be on research ultimately relevant to obstetrics- gynecology and/or its subspecialties. The Women's Reproductive Health Research Career Development Centers Program was initiated by NICHD in 1998 in response to concerns about the need for greater numbers of physician scientists in women's health research. This initiative continues and expands the scientific objectives represented in RFA HD-98-004 and RFA HD-99-001 and that were responsive to the 1992 Institute of Medicine Report, "Strengthening Research in Academic OB/Gyn Departments," the 1997 NICHD Extramural Program 5-Year Plan Report: "A Research Agenda for the Reproductive Sciences Branch," and report language in the Fiscal Year 1998 House Appropriations Report (No. 105-205; July 25, 1997). This RFA represents an expansion of ongoing research efforts to increase the numbers of physician scientists and support the research career development of junior faculty. Moreover, this initiative reflects the NICHD research agenda for expanding the scope of women's reproductive health research. Research Scope The research scope encompasses all areas of obstetrics and gynecology and its subspecialties: maternal-fetal medicine, gynecologic oncology, and reproductive endocrinology and infertility, as well as relevant fields such as urogynecology, adolescent gynecology, and the reproductive health of women with disabilities. Projects may be basic, translational, and/or clinical research, but must be within the biomedical and biobehavioral purview of NIH. Research with a primary focus on health care delivery, health services, or health policy is outside the scope of this RFA. Research focused on somatic health, for example, breast, cardiovascular, or musculoskeletal systems, should similarly not be proposed. MECHANISM OF SUPPORT This RFA will use the NIH Mentored Research Scientist Development Program (K12) award mechanism. Planning, direction, and execution of each component of the research and career development program will be the responsibility of the Principal Investigator and WRHR Scholar with the guidance of his or her mentor. This RFA is a one-time solicitation. Future unsolicited, competing- continuation applications based on this project will not be accepted unless the RFA is reissued. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is April 01, 2004. FUNDS AVAILABLE The NICHD and ORWH intend to commit approximately $5.6 million total costs [Direct plus Facilities and Administrative (F and A) costs] in FY 2004 to support up to 14 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 of up to $400,000 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 NICHD and ORWH provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, medical schools and other institutions of higher education o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions Eligible institutions are those that will not have a current WRHR Center at the time of the award. Foreign institutions are not eligible for this institutional career award. Applications may be submitted on behalf of departments of Obstetrics and Gynecology. An eligible institution will have a Department of Obstetrics and Gynecology (here understood to include a department providing obstetrical and/or gynecologic care as its primary function, regardless of title) that has as a primary teaching site either a hospital for women or an obstetrics- gynecology program with an identifiable organizational structure within a larger medical institution in the United States of America. Applicant institutions must have the clinical specialties and subspecialties and the clinical and research facilities sufficient to meet the purposes of the Center program, namely, to bridge clinical training with a career in basic, translational and/or clinical research relevant to women's reproductive health. Those institutions with a current Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Program, with a focus on women's reproductive health and/or located in a Department of Obstetrics and Gynecology or a department providing obstetrical and/or gynecologic care as its primary function must demonstrate how the addition of a WRHR Center will provide career development training that is separate and distinct from that offered by the BIRCWH Program, including avoidance of overlap in terms of research topics and personnel. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS 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. The Principal Investigator of a Center must be the Chair of the Department of Obstetrics and Gynecology, or equivalent. He/she should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary research and development program of this scope. SPECIAL REQUIREMENTS A. WRHR Scholars: The Scholar position is a junior faculty appointment, not a fellowship. At the time of the award, candidates for support as WRHR Scholars must: (1) be a physician holding the M.D. or D.O. degree; (2) have completed postgraduate residency training in obstetrics-gynecology or postdoctoral fellowship training in its subspecialties, if they have chosen to subspecialize; (3) identify an approved mentor with extensive research experience; (4) be able to spend at least 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; and (6) be a U.S. citizen or noncitizen national, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-155) or some other verification of legal admission as a permanent citizen. Individuals on temporary or student visas are not eligible. Completion of subspecialty training is not required of candidates practicing general obstetrics and gynecology. However, those who choose to subspecialize must have completed their fellowship. In order to accommodate the needs of those interested in participating in this program who may have had a career hiatus because of family responsibilities, uniformed service, etc., there is no limit on time elapsed since completion of training. However, Scholars cannot have more than six years of research training experience beyond their last doctoral degree. Support is in the form of a minimum of two consecutive 12-month appointments, renewable in annual increments for up to five years total, and is contingent upon satisfactory progress as reported to the Advisory Committee and to NICHD in the annual progress report of the Center. WRHR Scholars may not accept or hold any other PHS award that duplicates the provisions of this career award. Centers are encouraged to recruit members of underrepresented minorities, women, and candidates with disabilities. During the period of this award, WRHR Scholars are encouraged to apply for, and may accept and hold, independent research grant support with the consent of NICHD Program Staff. New Scholar appointments to the Center are made after approval by NICHD Program Staff. New Scholar appointments will have start dates of July 1 and January 1. B. Center Composition: Applicants must describe or propose a multidisciplinary career development program that will maximize the use of relevant research and educational resources to foster education, training, mentoring, and professional development of scholars, including women and minorities, in biomedical careers. The Center must have a strong research base, comprising the research investigations of established scientists who will provide expertise, resources, and mentoring to the WRHR Scholars. The research base must be broad and relevant to current areas of research interest and need in women's reproductive health. The environment should be one that will stimulate and increase the interactions between basic scientists and clinical investigators likely to benefit from mentored research career development. Of major importance, the Center must have a scientifically sound and equitable procedure for recruiting and selecting WRHR Scholars and projects to be supported. There must be documented evidence of an institutional commitment to support the Center's human and tangible resources and its goal of developing and retaining productive, independent investigators in areas of women's reproductive health concerns. There should be a plan for ongoing evaluation of the Center in terms of recruitment and retention goals, including for women and minorities, completion success, overall outcome, the curriculum, and program staff. For purposes of evaluating the impact of research career development programs, awardees must agree to provide NICHD with information on career outcomes for those appointed to the program. The Principal Investigator will supply this information at least annually. There should be a plan for periodic research meetings and networking for all Scholars and mentors. The NICHD will convene an annual meeting for Scholars and relevant program personnel at the NIH. C. Principal Investigator: The Principal Investigator of a Center must be the Chair of the Department of Obstetrics and Gynecology, or equivalent. He/she should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a multidisciplinary research and development program of this scope. As an option, the application may request a co-investigator to serve as the Program Director, with responsibility for some or all of the day-to-day operations of the Center. The Program Director should be an established investigator and have experience and qualifications complementing those of the Principal Investigator. The Program Director should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a program for developing junior investigators. The Program Director should have a record of accomplishment for mentoring successful investigators. D. Career Development Program: The K12 award provides five years of funding for the Center. The Center will support WRHR Scholars for periods of two to five years consisting of consecutive 12-month appointments. The program may be divided into two distinct phases, if appropriate: (1) the first one to two year basic and/or clinical science-training component, followed by, (2) an intensive research experience under the general guidance of a qualified mentor. At least 75 percent of the WRHR Scholar's full-time professional effort must be devoted to the K12 program per se. The remainder of the recipient WRHR Scholar's time may be devoted to developing other clinical or academic pursuits consonant with the objectives of the award. The 75 percent minimum effort in this program is intended to be primarily devoted to research; however, Scholars may, as needed, receive formal didactic coursework to support their career development, which may include, for example, biostatistics, epidemiology, health economics, clinical evaluation sciences, and clinical trials. E. 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 Center's research programs. It may include mentors. The two major functions of the committee are to evaluate: (1) applications from WRHR Scholar candidates, and (2) the overall conduct of the Center. Specifically, the committee makes recommendations to the Principal Investigator as to WRHR Scholar appointments, evaluates ongoing research activities annually (including the interaction and integrated nature of the Scholars' research experience), makes recommendations regarding their continuation, and makes recommendations to the Principal Investigator regarding priorities for use of the Resource Laboratory, if applicable. The committee may use institutional or outside consultants if needed. Plans to include members or consultants from outside institutions may be described, but such individuals should not be named. The committee is a formal part of the structure of the Center. It should meet regularly and keep written minutes, which will be reviewed as part of a competing or noncompeting application. In addition, an annual evaluation by the Advisory Committee is recommended. F. Institutional Environment: Applicant institutions should show commitment to the Center's goals, and provide assurances that the institution intends the Center and the supported WRHR Scholars to be an integral part of its research endeavor. Research facilities and training opportunities will be a critical part of the environment. Applicant institutions should provide a guarantee of 75 percent protected time for the WRHR Scholars for research. Applicant institutions should demonstrate commitment to recruitment and retention of racial and ethnic minorities and individuals with disabilities by collaborating with less research intensive and minority institutions. G. Mentors: Each WRHR Scholar appointed under the K12 award must have a primary sponsor who is recognized as an independent investigator and who is actively involved in basic, translational, and/or clinical research relevant to this initiative, and who has a successful record of providing research training of a type expected in this Center. An assigned mentor will provide guidance for the development of each WRHR Scholar assigned to the program. The mentor must be committed to continue this involvement throughout the WRHR Scholar's total period of development under the award. Mentors not included in this application must be approved by NICHD Program Staff before being assigned a Scholar. H. Resource Laboratory: The laboratory resources of the Center comprise the research laboratories of the established investigators serving as mentors, as well as a shared resource laboratory to be utilized by the mentors and the WRHR Scholars whose activities they will supervise. With strong justification, a shared Resource Laboratory may be requested as part of the Center, 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 WRHR Scholars. The shared Resource Laboratory might include scientific services such as, but not limited to, assays, molecular biology or biostatistics. Requests for this Resource Laboratory must be justified in terms of cost-effective enhancement of the research resources that will serve at least three WRHR Scholars' projects. The laboratories of the mentors are not supported directly by the K12 grant. The Resource Laboratory, if any, must be a new entity, not an extension or enhancement of an existing facility. The award may support professional direction of the Resource Laboratory, up to 50 percent effort, as well as technical assistance, supplies, equipment, and appropriate costs of operation. Institutional commitment to the shared Resource Laboratory must be demonstrated, and may take the form of providing or renovating space, purchase of required equipment, and/or support of personnel. The Principal Investigator, Program Director, and Resource Laboratory Director are responsible for efficient and equitable utilization of the Resource Laboratory based on recommendations from the Advisory Committee. I. Allowable Costs: 1. The Center structure may have these elements: a) Administration costs: Salary and fringe benefits for the Program Director, if any, up to 10 percent effort, as well as a part-time secretary, may be requested. No compensation may be requested for the Principal Investigator. Travel to an annual NIH Directors' meeting for the Principal Investigator and the Program Director, as well as travel to an annual NIH meeting for current Scholars, must be requested. Travel must also be requested for one additional training or scientific meeting per year for current Scholars. b) Resource Laboratory costs: Budgets may include salaries and fringe benefits for a Resource Laboratory Director (up to 50 percent), other technical staff, supplies, animals, and equipment purchase and maintenance. The budget for the Resource Laboratory must be included in the Administration cost. The sum of the budgets for Administration and a Resource Laboratory may not exceed $100,000 total costs (Direct plus F & A costs) per year. c) Facilities and Administrative costs: F & A (formerly, indirect) costs will be reimbursed at eight percent of modified total direct costs. 2. As part of the Scholars' costs, an application must request a minimum of three WRHR Scholar positions. The NIH will provide support for each WRHR Scholar position of up to $100,000 total costs (Direct plus F & A) per year. a) Salary Support: Scholars may be provided salary support of no more than $75,000 plus fringe benefits annually. The institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the Center. The total salary requested for each WRHR Scholar must be based on a full-time, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. b) Research Development Support: Within each WRHR Scholar's total award, up to $25,000 annually is allocated for research and development support, which can include expenses such as (a) travel to training or scientific meetings; (b) tuition, fees and books; (c) supplies and equipment; and (d) technical support and statistical or computer services. These career and development costs must be specifically documented for each individual candidate and must be specifically related to the candidate's research activities. They cannot be pooled and used for other programs unrelated or indirectly related to the research activities of individual scholars. Grant funds may not be requested for the following: Compensation for the Principal Investigator or mentors; direct support of the mentors' laboratories; compensation of administrative personnel normally paid from institutional overhead charges; administrative activities such as public relations, or health or educational services; travel of the Principal Investigator, Program Director or mentors to scientific meetings; costs of clinical care; and alterations and renovations. J. Evaluation: In carrying out its stewardship of human resource-related programs, the NICHD may begin requesting information essential to an assessment of the effectiveness of the Centers. Accordingly, awardee institutions are hereby notified that WRHR Scholars may be contacted after the completion of their career development experiences for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the Center. K. 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. Center 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-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 rebudgeted. 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 career award must receive prior written approval of the institute-awarding component. L. Special Leave: Candidates appointed to this program career award may engage in research experiences at another institution, including a foreign site, if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of the 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 requires the prior written approval of the PHS funding component and will be granted only in an unusual situation. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. M. Termination: The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. 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. N. Changes of Program: Awards are made to a specific institution for a specific Center under the guidance of a particular Principal Investigator and Program Director, if any. Changes in any of these parameters require prior approval by NICHD Program Staff. O. Progress Reports: An Annual Progress Report for the grant is required. This report should provide information such as any changes in the Center, a summary report of the evaluation of the Advisory Committee, and a description of the research and career progress of each Scholar. A final progress report, invention statement, and Financial Status Report are required upon termination or relinquishment of an award. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Estella Parrott, M.D., M.P.H. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B-01, MSC 7510 Bethesda, Maryland 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: ep61h@nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: mc113b@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Estella Parrott, M.D., M.P.H. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B-01, MSC 7510 Bethesda, Maryland 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: ep61h@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: The application must use the Research Career Award (RCA) section of the PHS 398. The table of contents for the RCA should be followed, except for those items modified under Sections I and II (below). The abstract should summarize the actual proposal, including the candidate pool, research topics, goal of the program regarding career development, and the environment. Section I - Basic Administrative Data: Include all the information requested in this RCA section. List as Key Personnel the Principal Investigator, Program Director, if any, Resource Laboratory Director, if any, and mentors. Do not list Advisory Committee members unless they are also mentors. Budget requests must be provided according to the instructions in form PHS 398. A composite page 4 for the entire Center budget request should be followed by one page 4 for the Scholars' costs and one page 4 for Administration and shared Resource Laboratory (if applicable) costs. Provide page 5 for the composite only. The requests for tuition and fees, books, travel, research development expenses, etc., must be justified and specified by category. Provide a Biographical Sketch and Other Support pages for all Key Personnel. Section II - Specialized Information: Make the following modifications in this RCA section. (1) Begin with an overview of the proposed Center: Summarize the immediate and long-term objectives of the Center. Describe the background, purpose and objectives of this career development Center. This description should include a discussion of the strategies to be used to ensure that the objectives of this RFA are met. The description should clearly show how the purpose and objectives meet the broader objectives and intent of NICHD to suppport the development of independent ob/gyn investigators in women's reproductive health. (2) The Scholar Candidate: Describe in general terms the pool of potential candidates including information about the types of prior clinical and research training. Do not name prospective Scholars. Describe the criteria to be used for candidate evaluation for selection as WRHR Scholars. Describe plans to recruit candidates, including those from racial or ethnic groups that are currently underrepresented in biomedical, behavioral, or clinical sciences and explain how these plans will be implemented. (3) Statement by Sponsor: Summarize the immediate and long-term career objectives of the Center, explaining how the Center will contribute to their attainment. Describe the career development plans for prospective candidates. Considering the Center goals and the likely goals of prospective candidates, describe a plan to provide the necessary research background and experiences, considering the expected range of prior research training in the applicant pool. For example, candidates with little previous research experience may require a phased developmental period in which the first phase of support under this award may include the first year or two of didactic training in basic and/or clinical research sciences. For these candidates, a second phase would be an intensive, supervised research experience to complete a longer developmental program. More experienced candidates may benefit from entering immediately into a mentored research experience of at least two years supported by this award. Provide brief summaries of career development plans that the Center will employ. The application should contain a description of how the career development plan will be tailored to the needs of the prospective candidates, taking into account their past experiences and competences, and should distinguish the plan from fellowship training. (4) Advisory Committee: Describe the composition of the Advisory Committee, identifying by name and role the internal members, and the desired expertise (but not the name or affiliation) of external members, if any. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies and the recruitment and retention of candidates. Describe how the Advisory Committee will monitor and evaluate candidates and the evaluation of the overall effectiveness of the career development program. (5) Environment and Institutional Commitment to Candidate: Describe the research infrastructure, facilities, etc. that are available and accessible to this Center. This includes the existence of funded laboratories and research activities that will meet and sustain the needs of the Center. Provide information establishing the commitment of the applicant institution, the Principal Investigator, and Program Director, if any, and the faculty mentors to providing developmental experiences that lead to independence in biomedical, behavioral, and/or clinical research relevant to women's reproductive health. Letters from faculty mentors are not required unless they are collaborators from other institutions. Include the specifics of institutional support. There is no dollar requirement, but significant commitment will be considered a strength. Provide a statement that Scholars participating in this Center will be guaranteed 75 percent protected time to devote to research and research career development. Collaborations between research-intensive and less-research-intensive institutions, and/or minority institutions, will be considered a strength. (6) Research Plan: For each faculty member proposed as a potential mentor, provide a paragraph describing the proposed research relevant to the goals expressed in this RFA, that may be the foundation of a WRHR Scholar's research experience in the Center. The research experiences may include basic, translational, and clinical research approaches to biomedical or behavioral problems in women's reproductive health. Lengthy, detailed protocols or plans for specific experiments should not be included. No limits are specified for the number of proposed mentors; however, fewer than six may not provide sufficient choice of projects, while more than 25 may dilute the focus on women's health. For each proposed mentor, describe the pertinent research experience and record of accomplishment in training junior investigators. In a table, name up to five current or former students or fellows the faculty member has trained, with dates (month/year), where trained, title of project, academic level, and present position and institution. Include a list of current funded research for each proposed mentor participating in the Center. The proposed Program Director, if any, should have a record of accomplishment for mentoring successful investigators. Describe the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise a program for developing junior investigators. Describe the career development record of the Program Director, as determined by the success of their former students or fellows. In a table, name up to five current or former students or fellows the faculty member has trained, with dates (month/year), where trained, title of project, academic level, and present position and institution. Include a list of current funded research. Applicants who will be using a General Clinical Research Center (GCRC) are requested to include a letter with the application from either the GCRC Program Director or the Principal Investigator. (7) Responsible Conduct of Research: Applications must include plans for instruction in the responsible conduct of research, including the rationale, subject matter, appropriateness, format, frequency and duration of instruction, and the amount and nature of faculty participation. No award will be made if an application lacks this component. (8) Current WRHR Centers: For eligible WRHR Centers submitting a competing continuation application in response to this RFA, provide brief summaries of the overall career development program that has been successful in preparing candidates for careers as independent investigators. Include information on the career outcomes of all Scholars that have entered your program over the course of the award. The summary should contain information on their promotions, publications, support from research grants or contracts, honors and awards, and other relevant professional activities. Include measures of success consistent with the nature and duration of the training period, and additional information helpful in evaluating the impact of your Center. (9) BIRCWH Program: Those institutions with a current Building Interdisciplinary Research Careers in Women's Health (BIRCWH) Program, with a focus on women's reproductive health and/or located in a Department of Obstetrics and Gynecology or a department providing obstetrical and/or gynecologic care as its primary function, must provide information on how the addition of a WRHR Center will provide career development training that is separate and distinct from that offered by the BIRCWH Program, including avoidance of overlap in terms of research topics and personnel. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: Program Overall: o The probable impact of the award on enhancing the capacity of the grantee institution to develop well-qualified new obstetrician-gynecologist investigators, thus enhancing women's reproductive health research locally and nationally. This includes the scientific and administrative expertise of the Principal Investigator and Program Director, if any, in preparing physician investigators for independent careers in basic, translational or clinical research. o Quality of immediate and long-term career objectives of the Center. o Quality of partnerships between research-intensive institutions and less- research-intensive institutions and/or minority institutions will be considered a strength. o For current WRHR Centers submitting a competing continuation application, the quality, overall impact, and effectiveness of their career development program in training and producing independent obstetrician-gynecologist investigators. Candidates: o Evidence of the availability of an adequate pool of potential WRHR Scholar candidates trained locally or recruited from elsewhere, who could benefit from receiving career development support. o Quality of plans to identify, recruit, and select candidates, with a commitment to research relevant to women's reproductive health, and the potential to develop as independent researchers. o Quality of efforts to develop a recruitment plan for women and those from racial and ethnic groups underrepresented in research. Career Development Plan: o Likelihood that the career development plan will contribute significantly to the scientific development of the candidates. o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence for the prospective candidates. o Consistency of the career development plan with prospective candidates' career goals and the multidisciplinary aims of the RFA. o Quality of the training in the responsible conduct of research. Research Plan: o Usefulness of the research plan as a vehicle for ensuring research training in women's reproductive health for all Scholars as described in the career development plan. Mentors: o Appropriateness of the faculty mentors' qualifications in the areas of research relevant to this RFA, including current and pending research grants. o Quality and extent of the mentors' proposed roles in providing guidance and advice to candidates. o Previous experience of the mentors in fostering the development of researchers. Resource Laboratory, if applicable: o Nature and quality of the optional new Resource Laboratory: technical merit, scientific justification, evidence of cost-effectiveness, procedures for quality control, allocation of resources among multiple users, qualifications of the Resource Laboratory Director and technical staff, and probable utility to the research projects of the WRHR Scholars. Environment: o Applicant institution's commitment to the Center's scientific development of the WRHR Scholars, and assurances that the institution intends the Center and the supported WRHR Scholars to be an integral part of its research program. o Adequacy of research facilities including availability of a General Clinical Research Center, if applicable, and training opportunities, including demonstration of the research base. o Quality of the environment for scientific and professional development, including opportunities for faculty positions that emphasize research. o Applicant institution's commitment to the appropriate balance of research and clinical responsibilities, including guarantee of 75 percent protected time for research for each WRHR Scholar. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: 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 criteria included in the section on Federal Citations, below.) 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) 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 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 30, 2003 Application Receipt Date: July 29, 2003 Peer Review Date: October/November 2003 Council Review: January 2004 Earliest Anticipated Start Date: April 01, 2004 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS 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. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at 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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at 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://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide 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 RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at 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.


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