Full Text HD-96-005 COOPERATIVE COMMUNITY BASED PERINATAL STUDIES AND INTERVENTIONS IN MINORITY POPULATIONS IN THE DISTRICT OF COLUMBIA NIH GUIDE, Volume 25, Number 44, December 20, 1996 RFA: HD-96-005 P.T. 34, FF Keywords: 0775013 Pregnancy Community/Outreach Programs National Institute of Child Health and Human Development Office of Research on Minority Health Letter of Intent Receipt Date: January 31, 1997 Application Receipt Date: April 3, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD), in cooperation with the National Institutes of Health (NIH), Office of Research on Minority Health (ORMH), invites new and renewal applications from institutions desiring to participate with the NICHD under a cooperative agreement in an ongoing multi-center research program designed to investigate topics related to the high infant mortality among minority populations in Washington, DC. It is the objective of this initiative to expedite the development of answers to these problems through a cooperative research network of participating centers in Washington, DC in cooperation with the NICHD. Research topics to be addressed include studies and interventions in women during pregnancy, infants and young children, as well as non-pregnant women during the preconception or interconception phase. Funding will be provided by ORMH and NICHD. Applicants must be able to propose research projects and to demonstrate relevant research experience pertinent to the objectives delineated in this RFA, qualifications of key personnel, and proven capacity to recruit community, clinic or hospital based populations for the planned interventions. The applicants must be willing and able to participate in a cooperative program of research and evaluation with other successful applicants. Peer reviewers convened by the NICHD will evaluate the qualifications and relevant research experience of the principal investigator and staff to do the proposed research, and the availability of resources necessary to conduct the research. It is anticipated that between six and eight organizations will be involved in this initiative. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-lead national activity for setting priority areas. This Request for Applications (RFA), Cooperative Community Based Perinatal Studies and Interventions in Minority Populations, is related to the priority areas of infant mortality, fetal deaths, low birth weight, high risk pregnancies and prenatal care. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402- 9325, (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by profit or non-profit organizations within the District of Columbia whether public or private, such as medical schools, universities, colleges, hospitals, laboratories, community based organizations, or units of local government. For-profit organizations interested in applying under this RFA should note that no profit or fees may be requested under this kind of assistance award. In addition, since there are no cost principles applicable to for-profit organizations receiving financial assistance awards, those set forth in Federal Acquisition Regulations in 48 CFR Part 31.2 will generally be used. Institutions may submit singly or in partnerships with two or more organizations or groups. Evidence of existing or proposed community affiliations and research capabilities must be represented regardless of which organization is submitting as the applicant entity. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program to assist the community in undertaking this coordinated population-based research effort will be a cooperative agreement mechanism, the research demonstration cooperative agreement (U18). This cooperative agreement provides "support for testing, by means of a research design, the effectiveness of the transfer and application of techniques or interventions derived from a research base for the control of diseases or disorders, or for the promotion of health. The project should be capable of making conclusions which are generally applicable to other sites." The major difference between a cooperative agreement and a research project grant is that there will be substantial NIH scientific and/or programmatic involvement with the awardees above and beyond the levels required for traditional program management of grants (Grants Policy Statement, DHHS Publication (OASH) 94-50, 000 (rev. April 1, 1994). Details of the responsibility, relationship and governance of the study to be funded under a cooperative agreement are discussed later in this document under the Section "Terms of Agreement." The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is February 1998. At this time the NICHD has not determined whether or how the solicitation will be continued beyond the present RFA. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of the awards will vary also. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NICHD and the ORMH, the award of a grant pursuant to this RFA is also contingent on the availability of funds for this purpose. FUNDS AVAILABLE It is anticipated that between 6 and 8 awards for participating centers will be made with an estimated total cost of $3,000,000 (including direct, facilities, and administrative cost) for the entire program for the first year ($1.5 million from NICHD and $1.5 million from ORMH). These funds will be allocated to Phase I: protocol design and implementation planning and Phase II: protocol implementation and participant recruitment. The actual cost of each approved protocol will be determined in Phase I. (See budget section for allowable costs) RESEARCH OBJECTIVES A. Background Infant mortality among blacks continues to be twice as high as among whites. In 1992, the infant mortality rate among whites in the U.S. was 6.9 per 1000 births and for blacks 16.8 per 1000 births, and the black-white ratio was 2.4:1. The overall infant mortality rate (provisional data) for the U.S. in 1994 was the lowest ever at 7.9 per 1000 births, but in Washington, DC, it was 20.1 per 1000 births. Similar disparities among blacks and whites exist for other birth outcomes related to infant mortality such as low birth weight and preterm delivery. Known risk factors of poor perinatal outcome include young maternal age, low level of maternal education, poverty, inadequate housing, lack of social support, being unmarried, late or no prenatal care, unintended childbearing, adverse health behaviors during pregnancy like smoking, drinking and drug abuse, as well as a number of medical risk factors, including preeclampsia, premature rupture of the membranes, urinary tract and vaginal infections. Certain causes of infant deaths occurring post-neonatally, such as infections, injuries and sudden infant death syndrome, are more common among black infants. B. Objectives and Scope To address these issues among minority populations in Washington, DC, the NICHD and the ORMH established a cooperative research network among six institutions in Washington, DC and the NICHD, as well as a Data Coordinating Center. The Steering Committee for this initiative identified a number of areas of research interest and coordinated the development of protocols which have been implemented. Studies currently in the field include an intervention to improve parenting skills among high risk mothers leading to better utilization of preventive health services for their infants, an adolescent pregnancy prevention school-based program, a study of barriers, motivators and facilitators to early entry and maintenance of prenatal care, a baseline study of injuries among infants and young children leading to emergency room visits in Washington, DC, a study of the determinants of lack of age-appropriate immunization coverage, and a study of characteristics of health services in neonatal intensive care units among most hospitals in Washington, DC. Information about these studies can be obtained from the NICHD as listed in the INQUIRIES section of this RFA. For this RFA, applicants should describe one or more research hypotheses for consideration by the group of awardees. We encourage collaborative efforts by groups, and research topics will be evaluated independently of resources required for network wide participation. Applicants should briefly describe research topics which: directly or indirectly address the problem of infant mortality and morbidity in the District of Columbia, clarify the relationship between the defined biological or sociological risk factors and infant mortality and morbidity, could be designed to address the question being asked, and which clarify the primary sources of individuals to be studied, accounting for possible co-interventions and reasonable accrual rates within the time limits of the initiative and the boundaries of the District of Columbia. This initiative calls for innovative investigations leading to a better understanding of the determinants and risk factors of the high rates of infant mortality and low birth weight among minorities in Washington, DC and development of interventions leading toward a reduction of those risk factors. Projects may be population-, clinic- or hospital-based or may deal with selected population groups. Study populations may be pregnant women, women of childbearing age, adolescents, or young infants, who reside in Washington, DC at the time of the investigation. Potential research topics may cover the development and testing of health education/health promotion interventions to effect a reduction in smoking, drinking, drug abuse or other adverse health behaviors during pregnancy. Other studies may deal with interventions during the preconceptual and interconceptional period to increase family planning service utilization and to reduce the risk of adverse birth outcome among high-risk women. Examples of types of research that could be conducted under this Cooperative Agreement include: o The development of effective outreach strategies to enhance participation in prenatal care. o The development of health education/health promotion interventions which are shown to be effective in this population, directed toward smoking, drinking and drug abuse, or other behaviors o Investigations and interventions aimed at preventing preterm delivery or intrauterine growth retardation. Because of the complex nature of the problem of the high infant mortality rate in Washington, DC involving social, demographic, health care delivery, access and utilization of health and social services and barriers to them, as well as medical and clinical problems impinging upon infant survival, the research approaches to address these problems involve contributions from many different disciplines, including sociology, behavioral sciences, health education, health service delivery, clinical obstetrics and pediatrics, nursing, epidemiology and statistics, and possibly some others. Examples of possible specific investigations (listed mainly for illustrative purposes) include: o There is an extensive research literature on smoking interventions in women before and during pregnancy, some of which have been tested in high risk inner city populations. Based on the currently available knowledge, a smoking intervention might be developed and tested in this population. o Findings from clinical trials which address the prevention of various obstetrical complications, including preeclampsia, if proven to be beneficial could be incorporated on a population basis into the content of prenatal care to test their overall efficacy in an inner city population. o The previous cooperative agreement included surveys and observational studies of barriers, motivators and facilitators of prenatal care, childhood injuries, and age-appropriate immunizations. Interventions could be developed to increase early entry and adherence to prenatal care schedules, reduce injuries in young children or increase immunization rates in children under the age of two building on the results of these Phase I studies. Although the studies funded under this RFA will differ in terms of their focus or disciplinary perspective, it is expected that investigators, through the Steering Committee, will develop common protocols and quality control procedures and will share the data generated by it. The selected protocol(s) will be subject to external scientific review by an uninvolved expert group, the Scientific Advisory Board and external community review by representatives of the community, the Community Advisory Board. The study will proceed into the implementation phase only with the concurrence of both the awardees and the NICHD. Recognition that it will not be possible to implement all the research projects proposed for technical review is essential. Other limiting considerations will include: (1) studies that are feasible to undertake in the proposed research population, (2) the financial resources available to the network, and (3) strategies that are likely to be the most productive and cost-effective in addressing the research priorities of the network. The data coordinating center (DCC), which will be chosen through a separate RFA, will provide management support and consultation in the design, execution, and analysis for multi-institutional studies in the field of infant mortality, and will ensure that the studies are of the highest scientific integrity and meet rigorous statistical standards. It will also assume responsibility for any protocol-related training, monitoring of sites for accurate and complete data collection, regulatory compliance, and research subject safeguards. The DCC will be responsible for the integrity of the scientific databases by editing and entering data, as well as designing and maintaining the study database(s). The DCC will be functionally independent of all research sites, although it could be physically located at one of them. GUIDANCE AND MANAGEMENT STRUCTURES It is expected that the first year of this initiative will be devoted to the prioritization of research projects approved during initial peer review, the detailed development of common protocols, manuals of operation, training manuals, etc., the finalization of implementation plans and time lines, and budget development. Protocols will be implemented and evaluated in the following years of the initiative. The management of the NIH-DC Infant Mortality Initiative includes four committees: (1) A Steering Committee, (2) A Scientific Advisory Board, (3) The Community Advisory Board, and (4) Data and Safety Monitoring Board. The roles of these committees are defined in the section on Terms and Conditions of this RFA. SPECIAL REQUIREMENTS The NICHD invites applications both from current members of the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia (competing renewal applications) and from new applicants. Applicants must be able to propose research projects and to demonstrate relevant research experience pertinent to the objectives delineated in this RFA, qualifications of key personnel, and proven capacity to recruit community, clinic or hospital based populations for the interventions being considered. Applicants must also demonstrate a willingness and ability to participate in a cooperative program of research and evaluation with other successful applicants. The following terms and conditions will be incorporated into the award statement and provided to the principal investigator(s) as well as the institutional officials at the time of award. Minimum requirements for applications are described below (See Application Procedures, also see review criteria). Terms and Conditions of Award These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used to assist the scientific community in conducting studies and interventions as part of the NIH-DC Infant Mortality Initiative will be a cooperative agreement (U18), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient"s activity by involvement in, and otherwise working jointly with, the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) 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 staff designated below. A. Awardees Rights and Responsibilities The tasks or activities in which awardees have primary substantial responsibilities include: identification of priority issues for research, research design and protocol development, participant recruitment and follow- up, collection, quality control, and transmission of accurate data in a timely manner, analysis and interpretation of data, preparation of publication of results of studies, interventions and trials done under this initiative, and collaboration with other awardees and NICHD scientists. Awardees will retain custody of and have primary right to their site"s data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. The data developed under these awards will not be disseminated publicly prior to publication or presentation of study results in a peer reviewed forum. The awardees will establish policies and procedures which direct their collaborative operations, including a publication policy. These documents may be amended and supplemented as approved by the Steering Committee. Awardees will be required to accept and implement the common protocol and procedures approved by the Steering Committee B. NICHD Staff Responsibilities Responsibility for review and oversight of these cooperative agreements will reside with the NICHD Program Officer. This role will include the following: oversight to assure the scientific merit of studies, interventions and trials done under this initiative, assistance in the efficient conduct of studies, interventions and trials, including ongoing review of progress, possible redirection of activities to improve performance, and frequent communication with other members of the Steering Committee, and initiation of a decision to modify or terminate a study based on the advice of the Data Coordinating Center, the Data Safety and Monitoring Board, the Community Advisory Board , the Scientific Advisory Board, and/or the Steering Committee. The NICHD Program Officer will have voting membership on the Steering Committee, and its subcommittees. The NICHD Program Coordinator will provide traditional extramural program management. In addition, the Program Coordinator will assist in coordination across institutions and will serve as Executive Secretary for the Scientific Advisory Board, reporting findings to the Steering Committee and protocol investigators. Other NICHD intramural scientific staff may collaborate with awardees in the studies. The NICHD Scientific Consultant, a staff member of the Epidemiology Branch of the Division of Epidemiology, Statistics and Prevention Research (DESPR) will provide scientific and technical assistance to the awardee investigators. This assistance includes, assistance in refining methodological issues of protocols, definition of study populations, analysis plans, and evaluation of study results. Grants Management responsibility: A grants management specialist in the Grants Management Branch, NICHD will administer the business and financial management aspects of the award. The NICHD reserves the right to terminate or curtail a study (or an individual award) in the event of substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breach of a protocol, a study reaches a major study endpoint substantially before schedule with persuasive statistical significance, qualified scientific investigators are not available to participate in the study, an awardee"s nonparticipation in the committee/group activities, or human subject ethical issues that may dictate a premature termination. C. Collaborative Responsibilities The management of the NIH-DC Infant Mortality Initiative includes four committees: (1) A Steering Committee will be responsible for the overall coordination of the study including: protocol prioritization, finalization, implementation and conduct of studies, and the preparation of publications. The Steering Committee will be composed of the awardee Principal Investigators, the Principal Investigator from the Data Coordinating Center and the NICHD Program Officer, each having one vote. The chairperson of the Steering Committee will be an outside consultant chosen by the NICHD in consultation with the Steering Committee. The program coordinator, scientific consultant, and a staff member from the Grants Management Branch will attend Steering Committee meetings. The Steering Committee chairperson will chair all meetings of this committee. The Steering Committee will meet three to four times per year. (2) A Scientific Advisory Board will advise the NICHD and the Steering Committee on the scientific merit and technical soundness of protocols which have been developed before their implementation. This advisory board will have expertise in areas relevant to the research topics of this initiative and will be chosen by the NICHD in consultation with the Steering Committee. The NICHD Program Coordinator will act as executive secretary of this Board and report the findings to the Steering Committee and Protocol investigators. (3) The Community Advisory Board will advise the NICHD and the Steering Committee on issues related to community acceptance and sensitivities, as well as appropriateness of a given research protocol. This advisory board will consist of individuals with a demonstrated knowledge of, and a history of involvement with, the community and will be chosen by the NICHD in consultation with the Steering Committee. (4) Data and Safety Monitoring Board will be established as needed to monitor the safety of ongoing interventions or clinical trials and advise on their conduct. Members of the Board will represent expertise in ethics, clinical trial design, and other disciplines relevant to the intervention or trial for which they are constituted. The members of the Board will be chosen by the NICHD. Subcommittees will be established by the Steering Committee, as it deems appropriate, the NICHD Program Officer will serve on the subcommittees as appropriate. The collaborative protocols will be approved by the Steering Committee. Data will be submitted centrally to the Data Coordinating Center. The Steering Committee will define rules regarding access to data and publications. An independent Data and Safety Monitoring Board will review progress of clinic trials at least annually and report to the NICHD. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee. D. Arbitration Any disagreement that may arise on scientific matters (within the scope of the award), between award recipients and the NICHD may be brought to arbitration. An arbitration panel will be composed of three members -- one person selected by the principal investigator, one person selected by the NICHD, and a third person selected by the two prior selected members. The decision of the arbitration panel, by majority vote, will be binding. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. These special arbitration procedures described above in no way affect the right 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. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59-14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. The usual NIH policies concerning research on human subjects also apply. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit by January 31, 1997, a letter of intent that includes a descriptive title of the research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions and the number and title of the RFA and the response to which the application may be submitted. 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 the NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. A letter of intent should be sent to: Barbara K. Wingrove Division of Epidemiology, Statistics and Prevention Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 7B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 594-1302 FAX: (301) 480-0649 Email: Barbara_Wingrove@NIH.GOV APPLICATION PROCEDURES The research grant application form PHS-398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional business offices and from the Extramural Outreach and Information Resources Office, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: asknih@odrockm1.od.nih.gov. Budget Facilities and administrative costs will be awarded in the same manner as for research project grants (R01). Allowable costs and policies governing the research grant programs of the NIH will prevail. In planning the budget section of the application, each applicant should submit budget estimates for all years. The first year"s budget for Phase I: Protocol design and implementation planning will be limited to the following maximum allowances: Principal Investigator: 10 percent effort Co-principal Investigator: 5 percent effort Site Coordinator: 50 percent effort Secretary: 50 percent effort Supplies and small equipment (itemize and justify) Not to exceed $4500 Travel to Steering Committees based upon four meetings a year lasting one day each attended by no more than three individuals per institution Other costs (itemize and individually justified) Not to exceed $2500 Budgets for implementation of protocols must include estimated research project costs for years 2 through 5 at the applicant"s institution. Actual annual budgets for subsequent years of the Initiative of the member institutions of the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia will be based on individual protocols in which these member institutions are participating. Budgets for protocols will be based on specific protocol requirements and availability of funds.Determination of actual cost allocations will be those requested by the individual protocol group(s) based on the requirements of the approved protocols and approved by the Steering Committee. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to do this 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 checked. The signed, typewritten original of the application, including the checklist, and three exact photocopies must be sent to: DIVISION OF RESEARCH GRANTS 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: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03A, MSC 7510 Bethesda, MD 20892-7510 Bethesda, MD 20852 (for express/courier service) Applications must be received by April 3, 1997. If an application is received after that date, it will be returned to the applicant without review. The DRG 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 DRG will also not accept an application that is essentially the same as one already reviewed. Letter of Intent Receipt Date: January 31, 1997 Application Receipt Date: April 3, 1997 NICHD Council review: September 1997 Anticipated Award Date: February 1998 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NICHD. Incomplete 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 scientific peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a triage process may be used in which applications will be determined to be competitive or noncompetitive based on their scientific merit relative to other applications received in response to this RFA. Applications determined to be noncompetitive by the scientific review committee will be withdrawn from further consideration, and the Principal Investigator will receive a summary statement reflecting the reviewers" evaluation. Applications judged to be competitive will be further discussed and assigned a priority score. They will then receive a second level review by the National Advisory Child Health and Human Development Council (NACHHD). General Considerations All applications will be judged on the basis of their scientific merit and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit of the application is important, it will not be the sole criterion for evaluation of the application. Other considerations, such as access to populations and qualifications of the project staff, will be part of the evaluation criteria. Review Criteria A. Experience with community-based perinatal studies or clinical trials and protocol development. Quality of the unit"s participation in either an intervention, clinical trial or study of a cooperative nature in the recent past (new applicants) or in ongoing protocols during the current grant support period (current members in the initiative). B. Qualifications of Applicant Interdisciplinary nature of potentially available scientific collaborators reflecting several of the disciplines required for these studies. Knowledge and experience in areas relevant to the conduct of research relevant to the area of infant mortality and low birth weight in minority populations, including interventions and clinical trials, and experience in research design. Commitment of staff for the satisfactory conduct of the study. Willingness to work as part of a cooperative study with other participating members in the NICHD as outlined in the RFA. C. Qualifications of Personnel Qualifications, research experience and commitment of the principal investigator and key personnel, particularly, but not exclusively, in the area of the proposed research. Scientific, clinical and administrative abilities and academic productivity of Principal Investigator and other team members. Willingness to work as part of a cooperative study with other participating members in the NICHD as outlined in the RFA. D. Available Population Access to populations which may be the target of both research projects or collaborative relationships in the community addressing concerns in maternal- child health. Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the research. Plans for the recruitment and retention of subjects will be evaluated. The scientific peer review group will also examine the provisions for the protection of human subjects and the safety of the research environment. E. Evidence of Collaboration Evidence of collaboration with other institutions, agencies, or community- based organizations for outreach, case identification, and participation in clinical trials. Every collaborative initiative cited should be accompanied by a letter of commitment specific to the activity of this RFA. F. Facilities and management. Availability of the resources necessary to perform the research, Institutional assurance to provide support to this study in such areas as fiscal administration, personnel management, space allocation. Facilities in which health care and support services are provided or arranged for, including hours of operation and provision for off-hour coverage. G. Data Systems Available Current data systems for populations currently in care, preferably computerized, including the description of the variables collected and the data quality and management activities. H. (Optional) Special Strengths Applicant Would Bring to the Initiative Special research strengths in the field of maternal-child health which would be relevant to the NIH-DC Initiative to Reduce Infant Mortality in Minority Populations in the District of Columbia. This could include specific scientific capabilities which are relevant and which might be shared or made available to the initiative and which would extend the scientific productivity of the research. I. Budget Budgets will be reviewed on the basis of appropriateness for the work proposed. AWARD CRITERIA Applications recommended by the NICHD Council will be considered for award principally on scientific and technical merit. Program balance, that is, the scope and variety of research strengths to enable a successful collaborative program, will be considered. Availability of funds may also determine the awards made. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged in an opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Barbara Wingrove, M.P.H. Division of Epidemiology, Statistics and Prevention Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 7B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 594-1302 FAX: (301) 480-0649 Email: Barbara_Wingrove@NIH.GOV Inquiries regarding fiscal matters may be made to: Ms. Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: ColvinM@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. The award will be made under the authority of the Public Health Service Act, Section 301 (42 USC 241), and administered under PHS grant policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not subject to review under the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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