RFA-HD-00-009: COOPERATIVE MULTICENTER MATERNAL-FETAL MEDICINE UNITS NETWORK

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.

COOPERATIVE MULTICENTER MATERNAL-FETAL MEDICINE UNITS NETWORK Release Date: April 3, 2000 RFA: HD-00-009 (This RFA has been reissued, see RFA-HD-04-023) National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 21, 2000 Application Receipt Date: July 11, 2000 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a Cooperative Agreement (U10) in an ongoing multicenter clinical program designed to investigate problems in clinical obstetrics, particularly those related to prevention of low birth weight, prematurity, and medical problems of pregnancy. The objective of this program is to facilitate resolution of these problems by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly than individual centers acting alone. The NICHD program staff will assist the Principal Investigators of the Maternal-Fetal Medicine network Units (MFMUs) and the Advisory Board in identifying research topics of high priority, and in designing and implementing protocols appropriate to the evaluation of optimum management in these areas. It is anticipated that approximately 13 to 15 clinical centers will be involved in the program. 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 Request for Applications (RFA), Cooperative Multicenter Maternal-Fetal Medicine Units Network, is related to the priority area of low birth weight. Potential applicants may obtain Healthy People 2010 at: http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit organizations, public and private. Organizations should have academically-oriented divisions of maternal-fetal medicine. The need for continuous and active communication among sites dictates that only institutions in the United States are eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) cooperative agreement (U10) award mechanism, an assistance mechanism (rather than an acquisition mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients activity by involvement in the activity and otherwise working jointly with the award recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreements are discussed below under Terms and Conditions of Award. FUNDS AVAILABLE NICHD intends to commit approximately $6.4 million in total costs [Direct plus Facilities and Administrative (F&A) costs] in FY 2001 to fund 13 to 15 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $325,000 per year, excluding F&A costs on consortium arrangements. Because the nature and scope of the research proposed may vary, it is anticipated that the size of the awards also will vary. Although the financial plans of NICHD 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. RESEARCH OBJECTIVES Background Modern obstetrical management, especially the management of high-risk pregnancies, has in some instances adopted principles of care and at times employed pharmaceuticals and methodologies without rigorous use of the controlled observation necessary for their objective evaluation. Often, the development of this medical specialty (and others as well) has been marked by the enthusiastic adoption of concepts and procedures followed by their modification or replacement, sometimes decades later, after extensive experience has failed to support their usefulness or has shown unexpected consequences. Costs involved in instrument purchase and employment have often been large, and uncertainties embedded in such obstetrical practices have contributed at least partly to the rising incidence of cesarean delivery. Regional differences in practice have complicated the field. In an attempt to respond to the need for well-designed clinical trials in maternal-fetal medicine, NICHD established a Network of Maternal-Fetal Medicine Units in 1986. Seven university units were selected from among respondents to an RFA. The Network Steering Committee, which consists of representatives from each clinical center, NICHD staff, and data coordinating center staff, evaluated several controversial issues for study. It then selected certain priority areas in which to develop protocols for randomized clinical trials. Trials were carried out on questions of postterm pregnancy, management of preterm labor, and prevention of preeclampsia. A Data Monitoring and Safety Committee also advises NICHD on research design issues, data quality and analysis, and ethical and human subject protection aspects of protocols. In the second grant period of the MFMU Network (1991-1996), clinical trials on stuck twins and varicella were performed. During the third funding period (1996-2001), clinical trials were initiated on fetal fibronectin as a predictor for premature delivery, cervical ultrasound during pregnancy, antenatal magnesium, asthma during pregnancy, maternal and neonatal outcomes after cesarean section, and progesterone for the prevention of premature delivery Objectives and Scope There are a number of controversial issues in maternal-fetal medicine that might be clarified by multicenter collaborative research. Funded Principal Investigators will cooperate with the NICHD Program Coordinator in identifying research topics of high priority and in designing protocols appropriate to the evaluation of superior, or even optimal management in these areas. The collaborative research may encompass any area of maternal-fetal medicine. However, special interest is encouraged in developing strategies for the prevention of preterm birth, evaluation of the causes or treatments of medical complications during pregnancy, and in the evaluation of interventions used during pregnancy and childbirth. The participating maternal-fetal medicine units (MFMUs), designated as clinical centers, will recruit, assess, and treat the subjects in the clinical research of the Network, with each MFMU being supervised by its respective Principal Investigator. The data center (funded through a separate RFA) will have primary responsibility for data management and analysis for Network research in collaboration with the Steering Committee. The NICHD expects that ongoing clinical trials dealing with outcomes after cesarean section, progesterone for the prevention of premature delivery, antenatal magnesium, multiple doses of antenatal steroids, and factor V Leiden mutation probably will continue into the continuation grant period for existing centers. New protocols may be developed before the start of the continuation. Centers that join the Network in the next award period (beginning April 1, 2001) may participate in the protocols ongoing at that time. The NICHD intends to enable the Network to initiate new protocols within the first year of the next award period. The topics of these protocols will be decided cooperatively by the Steering Committee with advice from the Advisory Board. Areas of interest include: techniques to reduce the risk of preterm labor and birth, and the evaluation of interventions used in pregnancy and childbirth. Guidance and Management Structures The management of the MFMU Network includes three committees (the Steering Committee, Advisory Board, and Data Safety and Monitoring Committee) as described below in Terms and Conditions of Award, under Collaborative Responsibilities. In addition, the Network has established Policies and Procedures that govern its operations, including publications. These documents are under periodic review, and may be amended and supplemented at the discretion of the Steering Committee and the NICHD. SPECIAL REQUIREMENTS The NICHD invites applications both from current members of the MFMU Network (competing renewal applications) and from prospective members (new applications). Minimum requirements for applicants are as follows (see APPLICATION PROCEDURES/Application Instructions, below, for detailed application instructions): Applicant units must have at least 2,700 births per year currently in the unit, with a minimum of 30 percent documented to be high risk pregnancies. A large majority of patients with obstetric complications who deliver in the MFMU must also receive prenatal care at the institution. The MFMU unit must have an established perinatal data system, preferably computerized, to collect and tabulate perinatal statistics. A research nurse must be designated for the full-time nurse coordinator position. To provide peer reviewers and NICHD an idea of the capabilities of investigators, all applicants must submit a concept protocol, briefly (two to three pages) summarizing a project that the applicant might submit to the Network for possible implementation at all Network centers. The departmental and institutional commitments to collaborative maternal-fetal research should be clearly documented by providing letters to the Principal Investigator, and by citing evidence of past support. Terms and Conditions of Award The following Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Part 74 and other DHHS, PHS, and NIH grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement (U10), 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 Program Coordinator, as described in these terms and conditions. (The substantial programmatic involvement by the NICHD Program Coordinator is above and beyond the levels required for traditional program management and stewardship of awards.) 1. Awardee Rights and Responsibilities The responsibilities and authorities of the awardees will be as follows: o Identification of priority issues for research. o Development and implementation of protocols. o Collection and transmission of accurate data in a timely manner. o Analysis of data and publication of results of the MFMU trials. All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process. The individual members will be required to project patient enrollment for a specific protocol during a specified time frame, continuation and level of funding will be based on actual recruitment. The MFMU Network will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 2. NICHD Staff Responsibilities The role of the NICHD MFMU Program Coordinator will be to aid the awardees and the Steering Committee in the following ways: o Assistance in the identification of important areas of study. o Assistance in the development of study protocols. o Assistance in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs. o Assistance in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee and the Advisory Board. o Assistance in reporting results in the community of investigators and health care recipients. o Assistance in the efficient conduct of the trials, including ongoing review of progress, possible redirection of activities to improve performance and cooperation, and frequent communication with other members of the Steering Committee. o Participation on the Steering Committee and all active subcommittees. Traditional program management/stewardship responsibility for review and oversight of the cooperative agreement award will reside with the MFMU Program Official. This role will include the following: o Assurance of the scientific merit of the trials, including the option to withhold support of a participating center if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met. o Initiation of a decision to modify or terminate a study based on the advice of the data center, Data Safety and Monitoring Committee, and Advisory Board with the mutual consent of the Steering Committee. 3. Collaborative Responsibilities: The management of the MFMU Network includes three committees whose functions are as follows: o A Steering Committee will be responsible for protocol development, assisted by the Advisory Board and the Data Safety and Monitoring Committee. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all Principal Investigators, one representative from the data center, and two NICHD staff. Participating NICHD staff will include the Pregnancy and Perinatology Branch MFMU Program Coordinator and a representative from the Epidemiology and Biometry Research Program. The MFMU Program Coordinator will be the only voting NICHD staff member of the Steering Committee. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters. An outside chairperson, who is not participating as a Principal Investigator, will be selected by the NICHD. o An Advisory Board will advise the Steering Committee in the identification and prioritization of topics for network research. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will be composed of individuals with expertise in clinical trials, biostatistics, epidemiology, perinatology, and neonatology, the Chairperson of the Steering Committee, the data center Principal Investigator, and the MFMU Program Coordinator. Additional members will participate based on the need for specific expertise. o A Data Safety and Monitoring Committee (DSMC) will monitor the safety of ongoing clinical trials and advise on their conduct. This committee will be established by NICHD and will represent expertise in ethics, clinical trial design, perinatology, neonatology, and basic science. In addition, the Network has established Policies and Procedures that govern its operations, including publications. These documents are under periodic review, and may be amended and supplemented at the discretion of the Steering Committee. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NICHD may be brought to arbitration. An arbitration panel will be constituted, consisting of three members: one selected by the Steering Committee (with the NICHD member not voting), or by the individual awardee in the event of an individual disagreement, a second member selected by NICHD, and the third member selected by the two previously selected members. The decision of the arbitration panel will be binding. This special arbitration procedure in no way affects the awardee’s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research, published in the Federal Register of March 28, 1994 (FR 59-14508- 14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, and available at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html . INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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, published in the NIH Guide for Grants and Contracts, March 6, 1998, and available at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed 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 this RFA. Although a letter of intent is 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 to Dr. Catherine Y. Spong at the address listed under INQUIRIES, below, by April 21, 2000. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, E-mail: Grantsinfo@nih.gov. Application Instructions The NICHD invites applications both from current members of the MFMU Network (competing renewal applications) and from prospective members (new applications). Instructions accompanying the PHS 398 (rev. 4/98) are to be followed in completing these applications. Applications should address the following items: A. Requirements for Applicants 1. Academic Productivity Provide evidence of recent research productivity by the applicant Clinical Center in previous or present clinical trials, especially of a cooperative, multicenter nature. Specifically, contributions in key areas such as protocol design, patient recruitment, data analysis and interpretation, and publication are important. Applicants who are current MFMU Network members should describe their participation in Network research in detail during the current competitive segment (e.g., number of patients recruited to each study, subcommittee memberships and chairmanships) New applicants should describe their recent participation in at least one randomized clinical trial, preferably of a multicenter nature. 2. Maternal-Fetal Staffing Physician staffing of the MFMU should include at least three maternal-fetal medicine subspecialists, each of whom would be available to take primary responsibility for one or more of the Network protocols at the unit. Provide complete descriptions of their training and qualifications in both clinical care and research, and their previous and current involvement in clinical research. Specifically, the academic status and academic career development pathways should be described as well as their experience in research design and implementation of collaborative clinical research (especially randomized clinical trials). The approximate percentage time protected for research by the academic department should be specified. The Principal Investigator should be a practicing maternal-fetal medicine specialist. Due to the demands and nature of the MFMU units, the identified Principal Investigator ideally should not have extensive departmental duties (e.g., as Department Chairman), rather he/she should be able to devote the required time to the development and implementation of the MFMU center. 3. Research Nurse Staffing A research nurse must be designated for the full-time nurse coordinator position. Also, additional research nursing staff should be available. Provide descriptions of these individuals training, experience, and involvement in clinical research. 4. Available Population Applicant units must have at least 2,700 births per year currently in the unit, with a minimum of 30 percent documented to be high risk pregnancies. Applicants that have numbers of births near the minimum or that have experienced a decline in annual births in recent years, should document efforts to maintain access to an adequate number of obstetric patients for research purposes. A large majority of patients with obstetric complications who deliver in the MFMU must also receive prenatal care at the institution. The patient population served by the MFMU must be characterized by demographics, obstetric parameters, and payment status. Indications must be given of the proportions of various subgroups, including minorities, that have been eligible and actually have been randomized, in previous or current clinical trials (see also section on Inclusion of Women and Minorities). In addition, centers with ongoing clinical trials should report those patients eligible for MFMU studies (not competing with institutional research). 5. Strengths of the MFMU A detailed description of the clinical attributes of the MFMU must be provided. This should include antenatal fetal testing, intrapartum diagnosis, laboratory testing, and perinatal pathology. Other institutional components related to the MFMU must also be described. In particular, the ambulatory facilities for prenatal and postpartum care must be presented, including the established policies and procedures for conducting clinical research in these facilities, in both low risk and complicated pregnancies. Also, the availability of an institutional pharmacy capable of supporting clinical research must be documented. A description of whether, and how, policies and procedures may have been modified to support neonatal clinical research in the past must be provided. 6. Perinatal Data System The MFMU unit must have an established perinatal data system, preferably computerized, to collect and tabulate perinatal statistics. Applicants must provide a detailed description of the variables collected, and the data quality and management activities. The applicant must also illustrate how the system has been used recently to plan and perform clinical research. All successful applicants must be willing to provide complete, accurate, and timely data to the MFMU. 7. Neonatal Intensive Care Unit One or more neonatologists active in clinical research at the institution must be designated. Such individual(s) must commit to serve as a consultant and possible collaborator in Network research. The academic status and career development pathways of these individuals must be described. A description of the organization and service load of the Neonatal Intensive Care Unit at the institution, including the existing newborn follow-up program and its research activities, must be included. If the institution submits applications in response to both the Neonatal Research Network RFA (HD-00-010) and the Maternal Fetal Medicine Unit RFA, the applicant must describe how the two research programs will be integrated. 8. Proposed Protocol Concept (all applicants) To provide peer reviewers and NICHD an idea of the capabilities of investigators, all applicants must submit a concept protocol, briefly (two to three pages) summarizing a project that the applicant might submit to the Network for possible implementation at all Network centers. The proposed concept will serve as an indicator of the applicant’s ability to participate in the development and design of cooperative protocols in the Network. The concept or another design on the same topic, may or may not actually be performed by the Network. It is anticipated that funded MFMU centers will be invited to submit the concepts included in their applications to the Network Steering Committee. For purposes of this RFA only, the protocol concept must address ONE of the following topics: Strategies to prevent preterm birth. Evaluation of the causes or treatments of medical complications during pregnancy. Evaluation of interventions used during pregnancy and childbirth. The concept should also demonstrate use of the applicant’s perinatal data system to estimate numbers of available patients eligible for the protocol at the institution. In addition, the protocol should address relevant ethical issues and the appropriate inclusion of minorities as subjects. 9. Intent to Participate There must be a clearly expressed intent to participate in a cooperative manner with other MFMU units, the NICHD, and the data center, in all aspects of Network research as outlined in this RFA. 10. Departmental and Institutional Commitments The departmental and institutional commitments to collaborative maternal-fetal research should be clearly documented by providing letters to the Principal Investigator, and by citing evidence of past support. This institutional assurance to provide support should address areas such as fiscal administration, personnel management, space allocation, procurement, planning, and budgeting. 11. Acceptance of Budgetary Mechanism (see also Budget Preparation below) Assurance of cooperation with the policy of capitation of research costs for each individual protocol, in addition to a base budget, should be provided from the department and from the institutional office of sponsored research programs. B. Optional: Special Strengths Available to The MFMU Unit All applicants, both competing renewals and new, are invited to describe briefly any special research strengths of the MFMU that may be relevant to Network research. Such strengths would represent state-of-the-art scientific capabilities that might be shared or made available to the Network, to expand the scientific productivity of the research beyond what it might be otherwise. Capabilities in areas such as genetics, placental function, or clinical pharmacology are examples of relevant strengths that could be included. Special administrative strengths also may be described. For example, both competing and new applications may describe the availability of potentially collaborating maternal-fetal medicine units in medical centers with which affiliations have been developed by the applicant institution for the purpose of clinical research. The requirements of this RFA must be met by such affiliated institutions. Another example of an administrative strength would be linkage with ongoing, specialized registries. Centers that propose to combine institutions or multiple sites must justify the proposed organization and provide a detailed logistical plan for cost-effective management. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator that identifies the level of support should be included with the application. C. Budget Preparation The instructions for budget requests provided with the research grant application form PHS 398 (rev 4/98) should be followed. F&A costs will be awarded in the same manner as for research project grants (R01). Budgets will be reviewed on the basis of appropriateness for the work proposed. Allowable costs and policies governing the research grants 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 budget at the time of application will be limited to a BASE BUDGET with maximum allowances as follows: Principal Investigator: 10 percent effort Research Nurse Coordinator: 100 percent effort Research Nurse: 100 percent effort Data Entry Clerk: 50 percent effort Supplies and Small Equipment (itemized and justified): Not to Exceed $4,500 Travel (a total of 10 trips to Bethesda per Network team): as appropriate Other costs (itemized and individually justified): Not to Exceed $2,500 When an application has been favorably recommended and is being considered for funding, the applicant will be required to complete protocol budgets for those studies underway within the Network. These budgets will consist of specific protocol-related allowances and will be capitated on the anticipated number of subjects to be enrolled in the study at the applicant MFMU. Ongoing annual budgets of MFMU Network centers will be based on individual protocols that will be funded through a capitation system. Each MFMU Network center will be given base costs (listed above), in addition to a flat fee per patient successfully enrolled and completed. For centers with GCRG funding, applicable capitation funds will be reduced relative to the amount of GCRC support. The Principal Investigator will be required to project patient enrollment for a specific protocol during a specified time frame, continuation and level of funding will be based on actual recruitment. Future years budgets should be limited to base budget costs, with an annual increment of base salary and travel costs not to exceed three percent (the maximum amount available for equipment, supplies, and other costs will not increase). Federal agencies shall use the negotiated rates for F&A costs in effect at the time of the initial award throughout each competitive segment of the project. Award levels for sponsored agreements may not be adjusted in future years as a result of changes in negotiated rates. Submission Instructions The RFA label available in the PHS 398 (rev. 4/98) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-00-009. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in the pdf format. 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. 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 should be sent to: L.R. Stanford, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) 301-496-1485 Applications must be received by July 11, 2000. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness by the NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council. Review Criteria o Criteria for Evaluation of Concept Protocol The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In their written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the 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, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the 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? o Criteria for Evaluation of Overall Application (1) Qualifications, Experience, and Commitment of Key Personnel: Scientific, clinical, and administrative abilities and academic productivity of the Principal Investigator and other team members, Knowledge and experience in areas relevant to the conduct of collaborative clinical research, especially randomized clinical trials, in maternal-fetal medicine. This should include specific experience in research design, Commitment of staff time for the satisfactory conduct of the study, Experience and qualifications of team members who would be responsible for data quality and management activities. (2) Protocols and Procedures: Quality of the unit’s participation in either (a) (new applicants) a randomized, clinical trial in the recent past, or (b) (current Network members) Network protocols during the current grant period, Willingness to work and cooperate with other MFMUs and the NICHD in the manner summarized in this RFA, Optional research strengths, as presented. (3) Facilities and Management Adequacy of administrative, clinical, and data organizational management facilities as described in the minimum requirements, Institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning and budgeting, Optional administrative strengths, such as affiliations with other research units. In addition to the above criteria, in accordance with NIH policy, all applications also will be reviewed with respect to the following: The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects also will be evaluated. The reasonableness of the proposed budget and duration in relation to the proposed research. The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. SCHEDULE Letter of Intent Receipt Date: April 21, 2000 Application Receipt Date: July 11, 2000 Peer Review Date: October 2000 Council Review: January 2001 Earliest Anticipated Award Date: April 1, 2001 AWARD CRITERIA Applications recommended by the National Advisory Child Health and Human Development Council will be considered for award based primarily on scientific and technical merit, as determined by peer review. Program balance, that is, the scope and variety of research strengths to enable a successful collaborative program, will be considered. Final selection of Clinical Centers for funding may be partly based in the need for diversity in the study population. Availability of funds may also determine the awards made. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Catherine Y. Spong, M.D. Pregnancy and Perinatology Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03B, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6894 FAX: (301) 496-3790 E-mail: spongc@exchange.nih.gov Direct inquiries regarding fiscal matters to: Ms. Carolyn Kofa Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17H, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-7006 FAX: (301) 402-0915 E-mail: ck1041@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to 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 routing 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices