COOPERATIVE REPRODUCTIVE SCIENCE RESEARCH CENTERS AT MINORITY INSTITUTIONS RELEASE DATE: April 15, 2002 RFA: HD-02-012 (Reissued as RFA-HD-06-017) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/) Office of Research on Women"s Health (ORWH) (http://www4.od.nih.gov/orwh/) LETTER OF INTENT RECEIPT DATE: July 16, 2002 APPLICATION RECEIPT DATE: August 13, 2002 This RFA is a reissue of RFA HD-00-019 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), the National Center for Research Resources (NCRR), and the NIH Office of Research on Women"s Health (ORWH) invite new and established basic science, translational, and clinical investigators to submit grant applications for Cooperative Reproductive Science Research Centers at Minority Institutions. Applications for these centers are sought from investigators willing to participate with the NICHD under a Cooperative Agreement (U54) mechanism in a multicenter cooperative research program. Center investigators will be expected to work with NICHD staff in facilitating research collaborations and interactions within and between centers. The purpose of this initiative is to form a cooperative program that will augment and strengthen the research infrastructure and research capabilities of faculty, students, and fellows at minority institutions by supporting the development of new, and/or the enhancement of ongoing, basic science, translational, and clinical research that focuses on topics deemed to be of high priority and significance because of their critical importance to reproductive health. Applications are encouraged that address priority areas in reproductive science that include, but are not limited to, the following broad topics: (1) reproductive biology, physiology, and genetics, (2) reproductive endocrinology, and (3) reproductive medicine encompassing infertility, gynecology, and andrology. The overall focus of the initiative is intended to stimulate the development of a competitive research environment in reproductive science at minority institutions. Reproductive scientists at minority institutions are invited to establish a collaborative partnership with NICHD-designated reproductive science research institutional programs, thereby benefiting from a broader range of resources, experienced leadership, and exposure to ongoing research projects. Such centers would bring together strong teams of experienced and new investigators, around a reproductive science theme, to share essential facilities, services, knowledge, and other resources. Long-term comprehensive affiliation can be expected to lead to the development of a stable relationship between the minority institution and the NICHD reproductive science program that can build and foster independent and competitive research capabilities at the minority institution. It is envisioned that each center will ultimately become a training and mentoring resource for developing and strengthening the research capacity of the nation by expanding opportunities for minority scientists, particularly those underrepresented within the scientific workforce. This solicitation embraces the NICHD Research Agenda for identifying and characterizing the factors and potential avenues of treatment related to priority areas of reproductive science, represents an extension of ongoing efforts, and demonstrates the Institute"s emphasis on expanding research support for reproductive sciences. Finally, a major hallmark of the initiative is its inclusiveness in addressing research across the reproductive life span among diverse populations of women and men, thereby improving the health of all citizens. RESEARCH OBJECTIVES Background There has been increased focus on addressing health disparities and improving the health status of all Americans. The increasing ethnic and racial diversity of the U.S. population heightens the need to understand the impact of health disparities over the reproductive life span of the American public. The ultimate goal of reproductive science research supported by the NICHD is to strengthen the science base and develop new knowledge leading to clinical applications that will foster improved reproductive health. One way to support this effort is to increase the cadre of new and experienced minority investigators in ongoing and emerging areas of reproductive science. Research in reproductive science remains relatively unexplored at minority institutions. Some minority institutions have had difficulties developing and sustaining independent programs in biomedical research, and there is a dearth of minority scientists who are pursuing successful biomedical research careers. The low level of involvement of minority institutions in reproductive science and the lack of sufficient training opportunities for minority scientists represent two major obstacles to developing an effective research effort aimed at addressing significant health disparities. This initiative will support the development of an enhanced research infrastructure in reproductive science at these institutions. Creating collaborations among minority institutions and other ongoing NICHD reproductive science research programs would integrate and take advantage of their respective expertise and experience. The Cooperative Reproductive Science Research Centers at Minority Institutions Program will bring together strong teams of experienced and new investigators, around a reproductive science theme, to share essential facilities, services, knowledge, and other resources. It is not the intent of this RFA to focus only on studying disease processes and disorders that disproportionately affect the reproductive health of minority groups, but to encourage and foster the development of an infrastructure at minority institutions needed to support the NIH research agenda. State-of-the-art reproductive science research centers at minority institutions would accomplish the following objectives: (1) create professional opportunities for minority investigators, (2) cultivate an academic and research milieu that would stimulate interest among students and fellows to pursue research careers in reproductive science, and (3) contribute to providing an environment in research excellence that would increase the competitiveness of minority institutions and investigators for traditional research project grants. It is envisioned that increasing the diversity among investigators and institutions will strengthen the scientific research conducted at these institutions, and participating in research supported by this initiative will enhance the experience, training, and career development of minority students and investigators associated with these institutions. NICHD"s strategic framework, "From Cells to Selves" (http://www.nichd.nih.gov/strategicplan/cells/), highlights selected scientific themes for future exploration and development that emphasize the importance of fostering training opportunities for basic science, translational, and clinical investigators, supporting the research infrastructure of institutions, and translating science to meet the needs of special populations and eliminate health disparities. The framework acknowledges that for innovative and creative scientific projects to succeed, the appropriate infrastructure, resources, and technologies need to exist. The Cooperative Reproductive Science Research Centers at Minority Institutions Program represents an expansion of research opportunities at minority institutions by creating strong reproductive science programs, stimulating partnerships with research-intensive institutions, enhancing the careers of underrepresented minority scientists, exposing graduate and undergraduate students to meritorious research, and stimulating long-term interest in reproductive science research careers among qualified underrepresented minority students. The Institute has demonstrated a long-term commitment to support reproductive science institutional programs that have the framework to stimulate multidisciplinary and interdisciplinary interactions among basic science, translational, and clinical investigators interested in establishing quality research projects in reproductive science. This RFA is specifically designed to encourage the reproductive science research community to form partnerships and support research-based centers at minority institutions, and to form a cooperative network with NICHD that fosters communication, innovation, and excellence. Thus, the major goals of this initiative are to support specialized reproductive science programs of distinction and to facilitate the development of a competitive research environment at minority institutions. Research Scope The Cooperative Reproductive Science Research Centers at Minority Institutions Program is composed of research-based center grants designed to support interactive groups of research projects and supporting administrative core units. The research activities included in these center grants must comprise, by definition, a multidisciplinary approach to the specific research topic areas announced in this RFA. These centers may have more than one theme, focus or emphasis, but all of the projects involved must be responsive to one or more of the designated reproductive science research areas supported by NICHD. There are a number of relevant research themes that would lend themselves to a cooperative center approach and are considered important for the potential development of new leads in reproductive science. Examples of the scope of research deemed responsive to this RFA include, but are not limited to, the following topics: (1) Reproductive Biology, Physiology, and Genetics o Biology of male or female gonads and reproductive tract, including genetic, cellular, molecular, physiologic, hormonal, developmental, and immunologic aspects of production and function of sperm and oocytes, and their union to form an embryo. o Gametogenesis, gamete maturation, gonadotropin regulation, role of gonadal somatic cells, ovulation, gamete transport, acquisition of fertilization potential, and function of corpus luteum. o Fertilization: in vitro and in vivo, abnormal and normal. o Blastocyst-uterus interaction in normal and abnormal implantation, pre- and peri-implantation embryo development. o Genetics of susceptibility to reproductive diseases and disorders. (2) Reproductive Endocrinology o Mechanisms of action of male or female steroid, protein, and peptide hormones and other compounds important for reproduction, including target cells of the hypothalamic–pituitary-genital tract. o Studies on the biosynthesis, secretion, and metabolism of hormones and other compounds involved in reproductive processes. o Modulation, signal transduction, and intermediary action of reproductive hormones by secondary messengers, receptor modulators [e.g., selective estrogen receptor modulators(SERMs) and selective androgen receptor modulators(SARMs)], and co-activators/co-repressors. o Establishment of cell lines and bioassays as models of reproductive endocrine activity. o Targeted genetic animal models of reproductive function and dysfunction. o Reproductive neuroendocrinology, including positive and negative feedback systems that influence reproductive processes, defining signal pathways. o Interactions among the nervous, immune, and endocrine systems in regulating reproductive processes. (3) Reproductive Medicine o Etiology, pathophysiology, prevention, diagnosis, and treatment aspects of male or female infertility and reproductive diseases and disorders. o Clinical studies and clinical trials. o Efficacy and safety of assisted reproductive technologies and other drugs, devices, and surgical treatments for infertility. o Andrology, including endocrine disorders, sperm production, maturation, transport, and function. o Endocrine dysfunction, including central, hypothalamic, pituitary, and target organ abnormalities of reproductive hormone production and action. o Benign gynecological conditions such as endometriosis, leiomyomata uteri, disorders (and normal function) of the pelvic floor and external genitalia. o Follicular maturation, ovulation and corpus luteum formation, egg quality, and uterine markers. o Mechanisms underlying hypothalamic, pituitary, and reproductive tract dysfunction in such conditions as gonadotropin deficiency, amenorrhea, polycystic ovary syndrome, and premature ovarian failure. o Female sexual function and dysfunction. o Nutrition, body weight, and exercise as determinants affecting reproductive function and fertility. (4) Risk Factors for Reproductive Disorders o Determination of the influence and role of risk factors such as race, ethnicity, culture, and co-morbid medical conditions or previous surgery associated with the occurrence of male or female reproductive disorders (including pathophysiology, etiology, diagnosis, treatment outcomes, and complications). Research proposals involving human in vitro fertilization and/or embryo transfer must be in compliance with NIH policies for such research and should not, therefore, include efforts or activities that create human embryos solely for research purposes. Prospective applicants are encouraged to consider relevant topics other than those listed here and to discuss their ideas with the program staff listed under WHERE TO SEND INQUIRIES, below. Guidance and Management Structures The Principal Investigator/Center Director affiliated with the applicant institution and the Co-director associated with the NICHD-supported reproductive science collaborating institution will be responsible for the scientific and administrative leadership of each center. The management of the Centers Program includes two committees (the Steering Committee and Scientific Advisory Board) as described below in "Terms and Conditions of Award." o Each Center Director and Co-director will participate as members of a Steering Committee that will assist in the coordination of all centers. A Chairperson will be chosen by a majority of the Committee members. The NICHD Project Coordinator will participate as a voting member and a member of the NICHD grants management staff will serve as a nonvoting advisor to the Committee. The Steering Committee will employ a consensus decision process to guide the centers in evaluating the progress of member center programs, their proposed new research initiatives within the general scope of the approved programs, and the need for collaboration either within or outside the center. The Steering Committee will meet at least once a year. o An independent Scientific Advisory Board will advise the Steering Committee in identifying and prioritizing research topics appropriate for study. The Scientific Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will consist of consultants with appropriate research expertise. A Chairperson will be chosen by a majority of the Board members. The Board will (1) review the broad goals and accomplishments of the centers, including any mentoring, career development, and training activities, (2) assess interim progress of all scientific projects and their relevance to the broad objectives of this initiative, and (3) assist in identifying, prioritizing, and reviewing proposed research projects that emerge during the course of the grant. The NICHD program staff will serve as ex officio member(s) of the Board. The Scientific Advisory Board will meet annually and must submit a written report to the NICHD that summarizes its evaluation and recommendations. MECHANISM OF SUPPORT This RFA will use the NIH Specialized Cooperative Research Center (U54) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. At this time, the NICHD has not determined whether this RFA will be reissued. The anticipated award date is March 1, 2003. The NIH U54 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE The NICHD and ORWH intend to commit approximately $2.25 million in total costs (Direct plus Facilities and Administrative [F & A] costs) in FY 2003 to fund up to three new centers in response to this RFA. NCRR intends to commit up to $1.5 million total costs per year for a period of five years, to support one successful application from a Research Center at Minority Institution (RCMI) Program 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 $1 million per year, including F & A costs on consortium arrangements. Because the nature and scope of the proposed research may vary, it is anticipated that the size of each award also will vary. Although the financial plans of the NICHD and NCRR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not know if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application if your minority institution has the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, and academic institutions that offer Ph.D., M.D., and/or equivalent health professional degrees o Fifty percent or more of the students enrolled are from racial/ethnic minority groups o A significant proportion of minority students are underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, and Pacific Islanders) o Located in the United States, its possessions or its territories o A collaborative affiliation has been established with an NICHD-designated reproductive science research institutional program. The collaboration should be for the purpose of facilitating and addressing the scientific objectives of the proposed center. Ideally, the collaborating institutions should be in close proximity to one another. However, if this is not possible, applicants should describe procedures and/or processes that will be used to overcome any potential problems associated with the geographical separation. Each NICHD-designated reproductive science research institutional program may participate in no more than one application in response to this RFA. A list of the designated NICHD programs may be obtained at http://www.nichd.nih.gov/RFA/HD-02-012/HD-02-012.htm and from the program staff listed under WHERE TO SEND INQUIRIES, below. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual from a minority institution 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. The Principal Investigator from the minority institution, who serves as the Center Director, must be an experienced researcher and be able to provide both administrative and scientific leadership. The Co-director, from the collaborating institution, must be an established investigator from an NICHD- supported reproductive science program. Participating collaborating investigators must be designated NICHD grantees (supported by grant mechanisms such as the U-series, R01, P01, or K12 institutional program). Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Center Characteristics The minimal requirements for a Center described in this RFA are as follows (see sections on Review Procedures and Award Criteria below): 1. Center Description. The applicant institution must offer Ph.D., M.D., and/or equivalent health professional degrees, 50 percent or more of the students enrolled must be from racial/ethnic minority groups, and a significant proportion of the minority students must be underrepresented in the biomedical sciences (e.g., African Americans, Hispanics, Native Americans, Alaskan Natives, Native Hawaiians, and Pacific Islanders). Each center consists of the applicant minority institution and the collaborating NICHD-designated reproductive science research institutional program. The Center Director is from the minority institution and is the Principal Investigator. The Co-director is from the collaborating reproductive science program. Joint research projects may be in basic science, translational or clinical research specifically addressing targeted areas in reproductive science. o Each center will represent a consortium consisting of the grantee institution and the required collaborative partnership with one of the NICHD- designated reproductive science institutional programs (as defined in this solicitation) that should have the flexibility to identify new opportunities through formalized planning, evaluation, and priority-setting activities. The applicant institution will be expected to support research activities and should have evidence of an existing research infrastructure. o The application should include letters of commitment from leadership within the minority institution and the identified collaborating institution that are fully supportive of this activity and that commit the additional resources necessary to ensure that these partnerships will have the maximum chance of success. Institutions comprising each consortium should be selected to facilitate attainment of the scientific objectives of the center. Each application must justify the specific pattern of collaboration in light of the scientific aims of the center and the resources that the participating institutions have to contribute, and should outline the mutual benefits to be gained as a result of the affiliation. Research partnerships are also encouraged between departments, divisions, and schools within a single institution to facilitate attainment of the scientific goals of the center. 2. Center Administration. The Principal Investigator/Center Director affiliated with the applicant institution and a Co-director affiliated with the NICHD reproductive science collaborating institution will be responsible for the scientific and administrative leadership of the center. o Each center partnership should develop a planning and evaluation component to assure the progress of the collaboration, and procedures should be in place for reviewing internal research proposals, enhancing infrastructure, and recruiting new investigators on the basis of their merit and potential to contribute effectively in achieving stated goals and objectives. o Each Center Director and Co-director will participate as members of a Steering Committee that will assist in the coordination of all centers. A Chairperson will be chosen by a majority of the Committee members. The NICHD Project Coordinator will participate as a voting member, and a member of the NICHD grants management staff will serve as a nonvoting advisor to the Committee. The Steering Committee will employ a consensus decision process to guide the centers in evaluating the progress of member center programs, their proposed new research initiatives within the general scope of the approved programs, and the need for collaboration either within or outside the center. The Steering Committee will meet at least once a year. o An independent Scientific Advisory Board will advise the Steering Committee in identifying and prioritizing research topics appropriate for study. The Scientific Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will consist of consultants with appropriate research expertise. A Chairperson will be chosen by a majority of the Board members. The Board will (1) review the broad goals and accomplishments of the center, including any mentoring, career development, and training activities, (2) assess interim progress of all scientific projects and their relevance to the broad objectives of this initiative, and (3) assist in identifying, prioritizing, and reviewing proposed research projects that emerge during the course of the grant. The NICHD program staff will serve as ex officio member(s) of the Board. The Scientific Advisory Board will meet annually and must submit a written report to the NICHD that summarizes its evaluation and recommendations. 3. Research Development Core. The function of the core is to strengthen, stabilize and consolidate interaction and cooperation between the minority institution and the affiliated NICHD reproductive science program. All research projects will be part of the Research Development Core. Each center will consist of at least three research projects that thematically address one or more research areas listed under Research Scope, above. All of the research projects must be of sufficient scientific merit to warrant independent support and must be an integral part of the center. It is required that at least three research projects be maintained at all times for the duration of the award. o Applicants are required to propose at least three meritorious reproductive science research projects and must describe the nature and scope of the proposed scientific research collaborations. Qualified investigators from the applicant minority institution or the collaborating institution should be selected to propose and lead research projects suited to their respective reproductive science expertise. A co-investigator from the other institution must be involved in the project. o Each of the proposed projects should effectively use the scientific and technical strengths of collaborating investigators, and investigators must clearly define the nature and extent of the research collaboration, addressing administrative, fiscal, and scientific matters in the application. All projects must include experienced investigators at identified NICHD reproductive science programs as collaborators. o At least two of the projects must be traditional R01-type research projects. Each project will involve participation by accomplished co- investigators from the collaborating institutions. Each R01-type research project may not exceed $250,000 in direct costs per year. o Each center may include, in addition to the two traditional research projects, one or more short-term research pilot projects. The total project period may not exceed two years, and each pilot project may not exceed $100,000 direct costs per year. The purpose of the short-term project(s) is to support pilot or feasibility studies that can lead to a traditional research project(s) funded as part of the center grant. Each project will involve participation by accomplished co-investigators from the collaborating institutions. The expectation is that successful pilot projects will become traditional R01-type research projects. 4. Administrative Core. Core resources supporting center development activities, educational activities, administrative services, salaries of key personnel, biostatistical and computer services, a planning and evaluation component, and shared equipment should be included. The function of the core is to strengthen, stabilize, and consolidate interaction and cooperation between the minority institution and the affiliated NICHD reproductive science program. The level of support for core resources must be commensurate with the level of research proposed and funded. The administrative core should include support for meetings (workshops and seminars) or other activities to explore new and expanded collaborative research, research training, and career development activities. Travel for the Center Director and key investigators at the minority institution to an annual meeting of NICHD Center Directors must be budgeted in the administrative core. This budget must also include travel for the Center Director and Co-director to the Steering Committee meetings. Allowable Costs Items fundable under an NICHD U54 grant include: a. Direct support of individual research projects. b. Research Development Core (research projects) and Administrative Core activities used by these research projects. c. Salaries and support for a limited number of administrative and clerical personnel, such as the Center Director, Co-director, Center Administrator, secretaries, and clerical support staff. The criteria defined under revised OMB Circular A-21 will be used by NICHD staff to determine if funding of administrative and clerical support staff is allowable. d. Administrative support services, including supplies, duplication, telephone, and maintenance contracts for equipment when not covered by institutional Facilities and Administrative (F&A) charges. e. At the discretion of the NICHD Centers Program, and as described in the RFA, travel to meetings to confer with other NICHD Center Directors and Administrators or to visit other center facilities pursuant to the administration of the center. f. Travel of Center Director, Co-director, and other investigators to scientific meetings. g. Travel of technical staff for training that would enhance the quality of the research projects supported by the U54 grant. h. Seminars or meetings designed to promote interdisciplinary interaction, education, or center cohesiveness. i. Consultants providing specific scientific and/or technical support to center projects or cores. j. Costs related to Steering Committee and NICHD Center Directors" meetings. Research Career Development and Training Opportunities While formal research training cannot be supported by this solicitation, it is understood that participation in research supported by this initiative can have significant impact on the career development of underrepresented minorities in the scientific workforce. Successful applicants may recruit and appoint graduate students and junior investigators with prior clinical and/or postdoctoral training, and use existing research training and/or career development programs to encourage qualified and interested underrepresented minorities to participate in research funded under this RFA. Cooperative Agreement Terms and Conditions of Award The following Terms and Conditions of Award are in addition to, and not instead of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Part 74 and 92, and other HHS, PHS, and NIH grant administration policies. Cooperative Agreements are subject to the administrative requirements outlined in pertinent OMB, HHS, PHS, and NIH guidelines, with particular emphasis on HHS regulations at 42 CFR Part 52 and 45 CFR Part 74. Facilities and administrative costs are calculated and awarded for cooperative agreement awards the same as for grants. The purpose of these cooperative agreements is to support a coordinated research program of centers pursuing high-quality reproductive science research at minority institutions. Consistent with the cooperative agreement mechanism, the dominant role and prime responsibilities reside with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NICHD program staff, as described in this announcement. The NICHD reserves the right to negotiate additional awardee terms and conditions based on recommendations from the Scientific Review Group and the National Advisory Child Health and Human Development Council and the National Advisory Research Resources Council. 1. Awardee Rights and Responsibilities The responsibilities and authorities of the awardees will be as follows: o Primary authority and responsibility remain with the awardee: to define the scientific objectives and pursue research approaches, to plan and conduct experiments, to collect and analyze resulting data, and to publish results, interpretations, and conclusions of the studies. The nature and scope of research on common protocols must be adequately documented and must ensure participation, sharing of methods and data among collaborating organizations. o The awardee will agree to (1) participate cooperatively and accept the coordinating role of the Steering Committee, which includes evaluating objectives and research goals of the centers and recommending modification, deletion or addition of protocols within the centers, (2) follow any common protocols in which they participate and any multicenter projects that are approved by the Steering Committee, (3) accept the advisory role of the Scientific Advisory Board, which includes providing guidance and recommendations, and (4) support the cooperative nature of the group process. o Each collaborating partnership should plan regular communications to discuss the progress and direction of its activities and to confirm that necessary interactions within the center are taking place. o The awardee will retain custody of and primary rights to the data and intellectual property developed under the award, subject to current Government policies regarding rights of access consistent with current HHS, PHS, and NIH policies. 2. NICHD Program Staff Involvement NICHD Project Coordinator The role of the NICHD Project Coordinator will be to assist the awardees, the Steering Committee, and the Scientific Advisory Board in the following ways: o Participate in the overall coordination of the program with the Steering Committee. This includes efforts to improve and strengthen inter- and intra- center cooperation among the research projects of the centers, facilitate interactions between the awardee and collaborating investigators, and retain scientific/programmatic involvement during the award performance period by contributing to planning and assessment activities, providing technical assistance, advice and coordination beyond typical program stewardship for grants. o Provide technical advice and expertise regarding scientific direction and program management to help shape a comprehensive framework for the development of the center, interact with each individual center grant awardee evaluating objectives and research goals of the particular center, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches, as warranted. The Project Coordinator will assist and facilitate this process and not direct it. o Assist research efforts by facilitating access to fiscal and intellectual resources, recommend additional research endeavors within the approved research and negotiated budgets, participate, where warranted, in data analysis, interpretation, and dissemination of study findings, and assist through review, comment, analysis and, where appropriate, co-authorship, in reporting results to investigators and health care recipients. o Serve as an ex officio member of the Scientific Advisory Board. Participate as a voting member of the Steering Committee and all active subcommittees. NICHD Project Officer: NICHD will appoint a Project Officer, apart from the Project Coordinator, who will: o Have the authority to recommend reductions in budget, withhold support, suspend and/or terminate the award if technical performance falls below acceptable standards for quality and timeliness. The program staff will, as required, help reprogram research efforts, including options to modify or terminate them, by mutual consent between the center and NICHD. This includes identifying jointly with participants of the Steering Committee and Scientific Advisory Board the need to add additional research projects to centers or to phase out a center project or core when performance standards are not met. o Carry out continuous review of all activities to ensure objectives are being met and maintain primary responsibility for stewardship of the award and overall responsibility for monitoring the conduct, progress, and fiscal management of the research program, provide assistance in reviewing and commenting on all major transitional changes of an individual center"s activities prior to implementation to assure consistency with required goals of the program, and reserve the right to include selected NIH extramural and intramural staff as consultants/experts on scientific issues during the performance periods of the award. o Exercise the normal stewardship responsibilities of an NIH Program Officer. 3. Collaborative Responsibilities Overall coordination of the program, consistent with the stated intent of the RFA, will be managed by a Steering Committee, Scientific Advisory Board, and the NICHD program staff. o The center partnership must have a planning and evaluation component in place for reviewing internal proposals for pilot and traditional research projects based on their merit and potential to contribute effectively to achieving high priority goals and objectives. The center partnership will have responsibility for directing the research projects and flexibility to discontinue and start new projects based on the regular evaluation of progress and identification of new opportunities through formalized and priority setting activities. Beyond this, the center should develop opportunities for information exchange, seminar presentation, and research training opportunities for students and fellows. o An independent Scientific Advisory Board will advise the Steering Committee in identifying and prioritizing research topics appropriate for study. The Scientific Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will consist of consultants with appropriate research expertise. A Chairperson will be chosen by a majority vote of Board members. The Board will (1) review the broad goals and accomplishments of the center, and identify areas of new opportunity based on continuing evaluation, (2) assess interim progress of all scientific projects and their relevance to the broad objectives of this initiative, and (3) assist in identifying, prioritizing, and reviewing proposed research projects that emerge during the course of the grant period. The NICHD program staff will serve as ex officio member(s) of the Board. The Scientific Advisory Board will meet annually and must submit a written report to the NICHD that summarizes its evaluation and recommendations for improvement. o The Steering Committee will be composed of the Center Directors and Co- directors from the collaborating institutions, and the NICHD Project Coordinator. A Chairperson will be chosen by a majority vote of the Committee members. The purpose of these meetings is to share scientific information, assess scientific progress, identify new research opportunities and potential avenues of collaboration, establish priorities, reallocate resources, and conduct the business of the cooperative research program. The Committee will have the responsibility for monitoring the progress of the research projects. The NICHD Project Coordinator will participate as a voting member of the Committee and any subcommittees. A member of the NICHD grants management staff will serve as a nonvoting advisor on the committee. The Steering Committee will meet at least once a year. 4. Arbitration When agreement between an awardee and NICHD staff cannot be reached on scientific/ programmatic issues that may arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the Principal Investigator, one person selected by NICHD, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. The process to resolve programmatic differences described above in no way affects the rights of a recipient of a cooperative agreement assistance grant to appeal an adverse determination in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. 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 8B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 E-mail: ep61h@nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Acting 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) Telephone: (301) 496-1485 E-mail: STRETCH@NIH.GOV o Direct your questions about financial or grants management matters to: Ms. Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 E-mail: kathy.hancock@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 July 16, 2002 and 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 8B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 E-mail: ep61h@nih.gov PREAPPLICATION WORKSHOP An information/technical assistance preapplication workshop addressing the scientific and administrative issues associated with this initiative will be held on May 20, 2002 in Bethesda, Maryland. The purpose of the workshop is to (1) familiarize the potential applicant with established NIH guidelines and criteria for review, (2) discuss the areas of NICHD programmatic emphasis, and (3) respond to potential applicants" technical questions about application format, procedures, etc. Logistic information, including time and location, will be posted at http://www.nichd.nih.gov/RFA/HD-02-012/HD-02- 012.htm and may be obtained from program staff listed under WHERE TO SEND INQUIRIES, above. For those who cannot attend the workshop, a written summary will be posted at that web site. 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: General Format: o The instructions accompanying form PHS 398 (rev 5/2001) are to be followed, except for those items modified below. For example, in lieu of the preprinted Table of Contents outline on Form Page 3 of PHS 398, a Table of Contents should be prepared listing all of the major sections described below and paginated to enable reviewers to find specific information readily. Pagination must be consecutive throughout the application. Applicants should ensure that all materials directly applicable to the review criteria (see below) are included in the body of the application, not in an appendix. o The Abstract should consist of a description of the composite research program, indicate the emphasis of the component research projects, and identify the purpose of the proposed core units. The Table of Contents should contain the types of information suggested below: Section I - General Information, Section II - Research Plan, and Section III – Appendix, if applicable. The following guidelines will provide directions and descriptions for preparing each section. Major areas to be listed and paginated in the Table of Contents are underlined. Section I - General Information A. Face Page o Complete all items on the application"s face page. This is Form Page 1 of the application, number succeeding pages consecutively. o On line 2, enter the RFA number (HD-02-012) and title ("Cooperative Reproductive Science Research Centers at Minority Institutions"), and mark the YES box. B. Description and Personnel o On Form Page 2, describe briefly the overall research program, indicate the emphasis of the component research projects, and identify the purpose of the proposed core units. o List scientific and technical personnel participating in the Cooperative Research Center. Use continuation pages as necessary, numbering consecutively. C. Table of Contents o Prepare the Table of Contents as noted above. The major areas to be listed are enumerated in these instructions. D. Budget Estimates o Prepare a series of composite Budget Tables for the Cooperative Research Center Grant as requested below. A separate detailed budget is required for each research project and for each core unit. 1. Composite Budget a. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of the PHS 398 to present the total direct cost budget for all requested support for the first year. For each category, such as "PERSONNEL," "EQUIPMENT," etc., list the amount requested for each research project and for each core unit. If consortium arrangements have been made involving other institutions or organizations, include total costs (direct and F&A) associated with such third party participation in the "CONSORTIUM/CONTRACTUAL COSTS" category. Costs for purchased services should be itemized under "OTHER EXPENSES." b. Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of the PHS 398 to prepare a budget, by category, that provides direct cost totals for each year of requested support. 2. Individual Project and Core Budgets a. First year (use Form Page 4 of PHS 398 for each) b. Total project period (use Form Page 5 of PHS 398 for each) o Consortium Budgets (if applicable) should be presented as described in Item 1 (Composite Budget), including a budget for the entire proposed project period. Total Direct and F & A costs of sub-awardees are to be shown under "CONSORTIUM/CONTRACTUAL COSTS" on individual research project or core budgets and a detailed consortium budget is to be inserted following the appropriate research project or core budgets. o Budget Justifications: Describe the specific functions of key scientific and technical personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For future years of support requested, justify any significant increases in any category over the first 12-month budget period. Identify such significant increases with asterisks against the appropriate amounts. If a recurring annual increase in "PERSONNEL" or "OTHER EXPENSES" is anticipated, give the percentage. E. Biographical Sketch o Biographical sketches are required for all key scientific and technical personnel participating in the research projects and core units as listed on Form Page 2. o Beginning with the Principal Investigator/Center Director, and following in alphabetical order, submit biographical sketches as described in the PHS 398," using sample format on the Biographical Sketch Format Page. Do not exceed four pages for each person. F. Resources o Complete the "RESOURCES" section using sample format on the Resources Format Page of the PHS 398 for the overall center. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. Use continuation pages as needed. Section II - Research Plan o A proposed five-year research plan that is responsive to the objectives set forth in this RFA and presents the organization and component functions of the center must be included. The research plan must contain the description of at least three collaborative research projects that will be mutually beneficial to participating investigators through coordinated, cooperative interactions. The plan should demonstrate the applicant"s knowledge, ingenuity, and commitment to developing productive, competitive reproductive science research. o Include a detailed Table of Contents with pagination (numeric only) at the beginning of Section II. Identify each research project or core unit by title, and assign each research project a number (I, II, III) and each core unit a capital letter (A, B, C) that reflects the order in which the research projects and core units are presented in the application research plan. For each research project and core unit, provide the names of the Principal Investigator/Co-Principal Investigator or Core Director/Co-director, and biographical sketches for personnel not identified previously. A. Introductory Overview o Although there is no page limitation for this section, applicants are encouraged to present a concise and succinct overview. Discuss the objectives of the center and general plans for the proposed grant period. 1. Center Description/Management o A description of and justification for the proposed research development core, which consists of the individual research projects, and the administrative core unit should be included. This should include the capabilities to meet or exceed the minimal requirements for a center, as stated in this RFA. List by title and investigator the component research projects and core units, showing the interrelationship between the research projects, the core units, and their relationship to the central theme. Applicants must also provide a detailed description of the process involved in selecting projects included in the center grant application as well as the process that will be used in evaluating their outcomes, and in selecting a new set of projects based on their merit and potential for meeting the objectives of the partnership. o Discuss the general rationale for the partnership and mutual benefits that the minority institution and collaborating institution expect to derive from the affiliation. Include a discussion of potential opportunities that the partnership may consider as the relationship and affiliation evolves. o The goals of the center must be described and background and significance of the topics being addressed discussed. In addition, each research project and core unit must be fully explained in light of how they contribute to achieving these goals. The organizational and administrative structure, the responsibilities of the Center Director, the Co-director, and the individual investigators, and the proposed mechanism for monitoring scientific progress must be addressed. Describe the organizational framework and provide an organizational chart. o A description of the qualifications and experience of the Center Director and Co-director in terms of their ability to provide scientific and administrative leadership, and how they plan to promote the collaboration and cooperation needed to achieve the center objectives. o The center must be prepared to participate in a cooperative manner. Document institutional and departmental commitment to support this cooperative study and staff dedicated to this program. o Clearly outline the chain of responsibility for decision making and administration, beginning at the level of the institution"s President or other senior official and including all key staff (e.g., Sponsored Program Administrator, Department Chair, and Dean). Describe the plans for day-to- day administration of the center, including program coordination, planning, and evaluation. Describe the proposed relationship of the center to existing research activities and, in detail, how the center will augment and strengthen the existing research infrastructure. o Include information on the use of the steering and advisory committees, and the method of determining core access and space assignment. o The applicant must identify and outline plans for support staff (e.g., grants management, administrative, and technical) to ensure the timely ordering of research supplies, equipment, and other resources essential to the scientific productivity of the research award. o Describe the availability of existing resources (e.g., clinical and laboratory facilities, patient populations, geographic distributions of space and personnel) and collaborative resources that can support a research program. o Briefly describe how the proposed activities will enhance the scientific capabilities of faculty, students, and fellows in reproductive science and strengthen the reproductive science curriculum. 2. Institutional Commitment/Supporting Infrastructure o A letter of commitment from a senior official (e.g., President or Dean) at the applicant institution should outline the commitment for resources and facilities to sustain and support the center throughout the period of funding and beyond the performance of this award, document institutional and department commitment and the availability of technical resources and facilities for the long-term support of the center, delineate features of the institutional environment that are relevant to the overall success of the reproductive science program, provide evidence that senior leadership has addressed issues such as tenure, promotion, research release time, and other personnel matters pertaining to the scientific success of the center. o A letter of commitment from a senior official (e.g., President or Dean) at the collaborating NICHD reproductive science institutional program should outline the commitment for resources and facilities to sustain and support the center throughout the period of funding, document institutional and department commitment and the availability of technical resources and facilities, and delineate features of the institutional environment that are relevant to the scientific success of the center. 3. Assurances and Collaborative Agreements. o Any arrangements for collaborative and cooperative endeavors or subcontracting should be highlighted. Letters of Intent to Collaborate and Letters of Agreement from consultants should be referenced here and included at the end of the appropriate research project or core unit. (This is usually covered under each research project and core.) B. Research Development Core Description o It is required that at least three research projects be maintained at all times for the duration of the award. These research projects must thematically address one or more research areas listed under Research Scope. o At least two of the research projects must be in the format of an R01-type application. One or more research project may be a short-term pilot project. The maximum direct costs for each R01-type project is $250,000 per year and for each pilot project is $100,000 per year. o Selection of qualified investigators from the applicant minority institution or collaborating institution to propose and lead meritorious research projects suited to their reproductive science expertise must be identified. A co-investigator from the other institution must be involved in the project. Each of the proposed projects should effectively use the scientific and technical strengths of collaborating investigators, and investigators must clearly define the nature and extent of the research collaboration, such that they fully explain the necessary administrative, fiscal, and scientific focus in the application. These projects must involve established investigators at affiliated NICHD-designated institutions as collaborators. o Each of the research projects and the core units proposed for inclusion in the center should be described using the PHS 398 application format. However, additional face pages are NOT necessary for each research project. Each research project description should include an abstract depicting the purpose and objectives of the research. Another paragraph should include a description explaining how the project relates to the overall priorities and objectives as described in the application. o Identify each project by a Roman numeral (I, II, III…) and a title. o For each component research project, a full description is to be provided following the format presented in Form PHS 398. A 25-page limitation will apply for each of the R01-type projects and a 10-page limitation will apply for the short-term pilot project(s). Unless stated otherwise in this RFA, the page limitations for each section provided in the PHS 398 instructions are to be used. Begin the presentation of each component research project on a separate page. For each project, include the following information: 1. Introductory Information a. Indicate: o Project Title o Project Principal Investigator, title, location o Other investigators, consultants, and collaborators, titles (Associate Professor, Postdoctoral Fellow, student). a. Abstract of Research Plan (use Form Page 2 of PHS 398) 2. Research Project Information: Discuss the purpose and nature of the project and its relevance to the application"s overall theme. Address the following: a. Specific Aims b. Significance c. Preliminary Studies. Describe the research project"s use of core unit services, including need for the services, and the advantages and cost effectiveness of core unit usage for the project. d. Research Design and Methods. For research involving human subjects, this section must address the inclusion of women, minorities and their subgroups, and children as research subjects, following relevant policy announcements. e. Human Subjects Research f. Vertebrate Animals g. Literature Cited h. Consortium/Contractual/Collaborative arrangements, including pertinent letters of assurance and intent. i. Consultants C. Administrative Core Description o A full description is to be provided following the format presented below. Unless stated otherwise in this RFA, the page limitations for each section provided in the PHS 398 instructions are to be used. o Briefly summarize the overall objectives of core unit, present the organizational framework or chart, highlight the decision-making process for use of core unit services described. o Explain the core facility in light of how it will contribute to achieving the goals of the center, and the ability to provide administrative oversight and coordination. Provide a description of key personnel, space, physical resources and projected use. Describe specific functions of the administrative core, such as the daily oversight, travel and logistic services needed to support the center. This should include organizing meetings, workshops, and seminars, documenting the results of activities, providing critical secretarial services, biostatistical and computer services, etc. Describe the planning and evaluation component and procedures for internal review of research proposals. o Include the following information: a. Objective(s) b. Staffing: Description of key professional and support staff functions c. Resources: Description of space and physical resources d. Services Provided: Describe projected services to other core units and research projects, and the center as a whole D. Checklist - As required in Checklist Form PHS 398 Section III – Appendix, if applicable o Include materials as appropriate (see PHS 398) 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. Acting Director Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone : (301) 496-1485 E-mail: STRETCH@NIH.GOV 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. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by 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 and the National Advisory Research Resources 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. The scientific and technical merit peer review focuses on three areas: (1) review of the overall center as an integrated effort, (2) review of the administrative core, and (3) review of the component research projects that make up the research development core. 1. Overall Center Evaluation Criteria o Strengths of the center in terms of the combined focus of the research projects and core units, and the significance of the application to the objectives of the program, as outlined in this RFA. The importance and relevance of each collaborative project to the achievement of the center program objectives. Feasibility of achieving the priorities and objectives of this collaboration within the five-year period. o Qualifications and experience of the Principal Investigator/Center Director and Co-director to provide scientific and administrative leadership, and the ability to meet the center"s demands of time and effort. Specifically stated and described willingness of the Principal Investigator/Center Director and Co-director to work and cooperate with other centers and with the NICHD in the manner summarized in this RFA. For key personnel from both collaborating institutions: the adequacy of the qualifications and experience to successfully plan for and achieve the objectives of center. o Appropriateness of the minority institution and NICHD-designated reproductive science research program collaboration with respect to the scientific aims of the center, including the use of partnerships to access scientific expertise from inter- and intra-institutional affiliations. Multidisciplinary scope of the center, its cohesiveness, coordination, and synergistic potential among the center and its projects. o The strength of the relationship of the applicant, key investigators and the collaborating researchers, particularly the academic qualifications, research experience, expertise and research productivity, as well as administrative and fiscal relationship. o Appropriateness of the structure and plans for the administration of the grant and center. An appropriate organizational and administrative structure for effective attainment of center objectives that considers arrangements for internal quality control of ongoing research, the solicitation of funds, day- to-day management, contractual agreements, and internal communication among center investigators. o Demonstrated institutional commitment to the center and its objectives in terms of providing research facilities and management support. The plans for the establishment and utilization of support structure (grants management, administrative, technical) to provide resources essential to carry out the scientific projects. o Documentation of institutional endorsement of the proposed five-year plan, including letters of commitment from senior institutional officials from both collaborating institutions. The degree to which the letters of commitment fully address and support the priorities and objectives of the center. o The institutional environment in which the research will be conducted, including the availability of space, equipment, and subjects, if proposed, adequacy of administrative, clinical and technical capabilities to conduct the research proposed, and the physical proximity of investigators or, if geographically separated, the plans to ensure a successful collaborative effort. Features of the institutional environment that are relevant or unique in assuring the success of the program. o Existing research infrastructure (laboratory space, equipment, clinical facilities, animal housing, and computer resources) and its commitment to the center that would facilitate and support the reproductive science research program. The relationship of the proposed program to already existing reproductive science programs, if applicable. o The degree to which this center, if fully successful, would enrich the academic and intellectual milieu for reproductive science research at the minority institution, and the feasibility and potential for underrepresented minority investigators to gain research experience and independence. 2. Administrative Core Evaluation Criteria o Quality and availability of core resources, and the appropriateness of the use of the administrative core services. The adequacy of the structure and organization for effective attainment of center priorities and objectives. Evidence that the core will provide the necessary administrative support, such as oversight and management, biostatistical and computer services, planning and evaluation component, contractual agreements, support, travel, and logistic services, and internal communications among investigators required for the successful completion of the research projects. Shared laboratory resources, including animals, reagents, supplies and equipment may be included in the Administrative Core. o Qualifications, experience and commitment of co-Investigators and key personnel designated to support the administrative core. 3. Research Development Core: Research Project Evaluation Criteria Each research project (as defined in this solicitation) will be individually evaluated for its scientific and technical merit using the standard NIH review criteria. (1) Significance: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) Investigators: Are you, the key investigators and collaborative investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level and that of the key investigators and other collaborative researchers? Are the key investigators and collaborative investigators committed to devote the required time and effort to the research project and the center? Are the key investigators and collaborative investigators willing to cooperate, as appropriate, with NICHD assistance in the manner summarized in this RFA. (5) Environment: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the projects proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below). o DATA SHARING: The adequacy of the proposed plan to share data, if appropriate. o 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: July 16, 2002 Application Receipt Date: August 13, 2002 Peer Review Date: October/November 2002 Council Review: January 2003 Earliest Anticipated Start Date: March 1, 2003 AWARD CRITERIA Each minority institution is eligible to receive one award. 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 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 AMENDMENT "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. 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 No. 93.864, Population Research, and No. 93.389, Research Infrastructure, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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