Full Text HD-94-016 COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK NIH GUIDE, Volume 23, Number 12, March 25, 1994 RFA: HD-94-016 P.T. Keywords: National Institute of Child Health and Human Development Letter of Intent Receipt Date: May 1, 1994 Application Receipt Date: July 19, 1994 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate, with the assistance of NICHD under cooperative agreements, in an ongoing multicenter cooperative program designed to conduct clinical studies investigating problems in adult reproductive medicine, including infertility, reproductive endocrinology, gynecology, and andrology. The objective of this program is to facilitate resolution of these problems by maintaining a network of sites that, by vigorous patient evaluation using common protocols, can study large numbers of patients and can provide answers more rapidly than individual sites acting alone. The benefit of this activity will be to the public: the infertile couples, the individuals with reproductive diseases and disorders, and their health-care providers. 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-led national activity for setting priority areas. This Request for Applications (RFA), Cooperative Multicenter Reproductive Medicine Network, is related to the priority area of family planning. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private. Minority individuals, persons with disabilities, and women are encouraged to apply. The need for continuous and active communication among sites dictates that only institutions in the United States will be eligible to apply. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a 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 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 later in this document under the section "Terms and Conditions." The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is April 1, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of 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, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time, the NICHD has not determined whether or how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE It is anticipated that one award for the Data Coordinating Center and eight awards for Clinical Sites will be made, with an estimated total of $1,800,000 (including direct and indirect costs) for the entire program in the first year. Up to five competing continuation awards and at least four new awards are expected. RESEARCH OBJECTIVES Background Within the mission of the NICHD, a preeminent goal is assuring the birth of wanted babies through studies on human fertility and infertility. To this end, the Reproductive Sciences Branch supports research on human fertility and infertility and diseases and disorders of the human reproductive system. Particularly in the field of infertility, but in other aspects of reproductive medicine as well, uncontrolled, trial-and-error methods have led to undeserved claims of effectiveness and resulted in significant costs, both human and financial. Even for "male factor," the female partner usually undergoes treatment. Little is available for diagnosis or treatment of clinically normal men with a sperm defect. There are gynecologic conditions that result in significant morbidity, particularly in women of reproductive age. Conditions such as endometriosis, leiomyomata uteri, abnormal uterine bleeding, and others can cause pain, disruption of function in the workplace and the home, and other problems beyond or beside effects on fertility. Many of these conditions can lead to hysterectomy or other major surgery. In some cases, alternative management strategies might have been effective, but were not understood, accessible, or affordable. Following a 1988 concept clearance review by a group of independent experts, an RFA was issued in 1989 to initiate the Cooperative Reproductive Medicine Network. Its overall goal has been to address the need for rigorous controlled evaluation of diagnostic and therapeutic practices in the area of reproductive health care. Since its inception in 1990, a protocol study comparing intrauterine and intracervical insemination, with or without ovulation induction by exogenous gonadotropin, has been developed and is being conducted by the Network. Despite this and other examples of careful, modern research, there is yet much to be done. Only recently has the basic science base of knowledge about the pathophysiology of common, distressing conditions begun to approach the point at which clinical studies can use this new knowledge as a practical foundation. The report language accompanying both House and Senate appropriations bills for fiscal 1994 emphasizes infertility, and the Senate report also highlights endometriosis and uterine fibroids as examples of needed gynecology research. Use of the cooperative mechanism has many advantages. The NIH staff participant will contribute scientifically to consensus decision-making and maintaining balance among the participants. In this way, the group can identify issues with a high degree of objectivity, develop well-designed protocols, provide to participants expert statistical consultation in experimental design and analysis, and provide a large patient base, so that tests and treatments could be evaluated more rapidly and with greater statistical validity than otherwise. The anticipated efficiency of communication among investigators and dissemination of information to practitioners and the public would lead to more effective patient care and more economical use of resources. Objectives and Scope There are a number of controversies in Reproductive Medicine that would lend themselves to cooperative study. The following should by no means be viewed as exclusive, and are intended only as examples: o In vitro fertilization: Patient selection, comparison of treatment protocols to optimize live birth rates. o Endometriosis: Controlled trials of diagnostic methods and treatments, examining post-treatment fertility and/or symptom reduction. o Polycystic ovarian syndrome: Definition, subgroups, response to therapies. o Leiomyomata: Controlled trials of diagnostic methods and treatments, examining post-treatment fertility and/or symptom reduction. o Varicocele: Effect on fertility, benefits of surgery. o Male infertility: Diagnosis and treatment directed at the male. The Network will include approximately eight clinical sites or "Reproductive Medicine Units" (RMUs) and a Data Coordinating Center (DCC). There will be two domains within the Network: Infertility/Andrology and Gynecology. "Infertility" is intended to encompass male factor, female factor, and unknown cause. It is anticipated that initial Network activity would encompass one protocol from each domain, with one RMU acting as lead unit for each protocol. The RMUs will recruit, evaluate and treat the participants in either or both of the clinical studies. The Data Coordinating Center will have primary responsibility for data collection and management for each trial. A member of NICHD program staff, serving as Research Coordinator, will cooperate with the funded principal investigators in identifying research topics of high priority and in designing protocols appropriate to the evaluation of optimum management in these areas. Guidance and Management Structures The Steering Committee will consist of the principal investigators from each RMU, the principal investigator of the DCC, and the NICHD staff Research Coordinator; a nongovernment chairperson will be designated by the Steering Committee. A member of the NICHD grants management staff will serve as advisor to the Committee. The Steering Committee will develop by consensus the protocols to be carried out under these cooperative agreements, and supervise the conduct of the studies. A Data Safety and Monitoring Committee (DSMC) convened by the NICHD will have responsibility for reviewing proposed clinical protocols, and for making a recommendation to the NICHD whether to accept, modify, or decline such proposed studies. The DSMC will enlist additional ad hoc scientific and/or clinical experts as needed to conduct each review. Because implementation of a new protocol would constitute a major change in scope, approval by the Director, NICHD, will be required before such implementation. The DSMC will monitor data collection and analysis by the DCC, including any reports of adverse effects. When appropriate, the DSMC will conduct an interim evaluation of the data with respect to the need to terminate studies, either because the data suffice to answer the problems posed, data collection provides support for an alternative study initiative, or because experience has proven the research not to be feasible. Time Sequence It is anticipated that the program will conduct its activities according to this general outline: Initially, the Steering Committee will review and identify issues of importance in reproductive medicine. It will consider items proposed for study by the Network from those listed above in "Objectives and Scope" and others suggested by participating units. Within each of the Infertility/ Andrology and Gynecology domains, the Steering Committee will rank by priority a series of issues that are substantive, lie within the scope of existing technical capability, lend themselves to multicenter evaluation, involve sufficient numbers of patients to be of consequence in terms of morbidity, and comprise significant public health need. In this and subsequent activities, the Steering Committee will attempt to use electronic and telecommunications whenever possible. From the list of important issues for each domain, the Steering Committee will generate diagnostic or treatment protocols and agree on lead units for the two domains. Each protocol is to be acceptable by all the participants, adequate for appraisal of the research issues defined, and amenable to data collection in a single format acceptable to all units. Satisfactory controls will be incorporated, and attention will be given to maximize the number of studies possible with minimum data collection. Protocol subcommittees may be constituted to develop protocols more efficiently. Participating reproductive medicine units will incorporate the protocols into the clinical management of patients selected for study. The units will supervise the collection of data with adequate attention to the fidelity of records and transcription and provide information in uniform data format for analysis. The mode of data transmission and analysis will be determined by the Steering Committee in conjunction with the recommendations of the Data Coordinating Center. Data summaries will be provided to the Data Safety and Monitoring Committee on a semi-annual basis, or as indicated by study development. Format and content of final reports and the dissemination of information to the scientific community will be determined by the Steering Committee. Beginning approximately six months after the start of data collection, the Data Safety and Monitoring Committee will examine the aggregated data and make recommendations to NICHD on the need to modify or terminate studies, as described above. As studies are terminated, the Steering Committee may reinitiate identification of new issues and the institution of new protocols. SPECIAL REQUIREMENTS Scientific Content The NICHD invites applications both from current members of the Network (competing renewal applications) and from prospective members (new applications). Minimum requirements for applicants are as follows (see also Review Criteria and Procedures, below): o Requirements for Clinical Site (RMU) Applicants 1. Participants must be based in departments providing both inpatient and outpatient reproductive health care. 2. The unit must have a history of previous successful clinical research, and expertise in research design, biostatistics, and the use of clinical protocols. Ability to enroll sufficient numbers of patients for meaningful studies should be documented. 3. The unit must be able to demonstrate past and existing excellence in collecting and maintaining clinical data on its patients. Applications should state the numbers of patients seen annually for infertility overall and for the other reproductive health diagnoses listed as examples in II, above. 4. The principal investigator should be able to make a substantive, long-term commitment of effort to Network responsibilities. The unit should have physician staff representing several areas of expertise, either based in the participating department or available as collaborators. At a minimum, these would include Obstetrics and Gynecology, Reproductive Endocrinology (either in OB-Gyn or Internal Medicine), and Andrology (either in Internal Medicine or Urology). 5. An experienced research nurse must be among the key personnel, and additional research nursing staff should be available. 6. Laboratory facilities must be available for appropriate testing of patients and subjects, such as hematology, blood chemistry, endocrinology, microbiology, radioimmunoassay, and semen analysis. 7. Appropriate imaging services must be available, including ultrasound, contrast studies, and other radiological and related techniques that may be required to diagnose and follow the conditions under study. 8. The unit must be prepared to participate in a cooperative manner with other clinical centers and the Data Coordinating Center in the delineation of research protocols, statistical methods, uniform data formats, and data transfer. 9. There must be firm institutional and departmental commitments to support this cooperative study and a strong staff dedication to adhere to programs jointly defined and generate data of high fidelity to ensure success. 10. Because the protocols for investigation will not be written until after awards are made, it is not possible for RMU applicants to propose the exact work that they would actually carry out if funded. Therefore, to provide peer reviewers and NICHD an idea of the capabilities of the investigators, applicants for RMUs must submit a "concept" protocol for a new study that that site might expect to conduct as a participant in the Network. Applicants should note carefully that the "concept" study proposed may or may not actually be performed by the Network as one of its protocols, but is requested to serve as an indicator of the applicant's ability to participate in the development and design of protocols for cooperative clinical investigations. It is anticipated that the Steering Committee will include the "concept" protocols submitted by the funded RMU sites in its consideration of topics for actual protocols. For purposes of this RFA only, it is suggested that the "concept" protocol address one of the following topics: 1. Ovulation induction procedures for improved outcome in human in vitro fertilization 2. Fertility-sparing management of endometriosis, uterine myoma, or abnormal uterine bleeding 3. Improved management of ectopic gestation 4. Role of evaluation of the luteal phase in management of infertility 5. Role of immunologic evaluation and intervention in management of infertility 6. Effects of varicocele and the treatment thereof on fertility The choice of a "concept" topic from one domain will not necessarily limit the participation of an RMU in the other domain in the event that it is funded. The protocol should be written specifically for this Network, and will be a key factor in evaluation of the application. The following are highly desirable: 1. The cooperating institution should have a computer facility linked to a network such as BITNET or Internet, and the unit should include an authorized user knowledgeable in computer data storage and retrieval. 2. The site should have previous experience in multicenter clinical trials. 3. If the specialty of the principal investigator is in disorders of one sex, the designation of a co-principal investigator with expertise in disorders of the opposite sex will be viewed as a strength. o Requirements for Data Coordinating Center (DCC) Applicants 1. The applicant must have demonstrated prior experience as a Coordinating Center in multi-center studies. 2. The Principal Investigator, with other staff, must have appropriate biostatistical, data management, and coordination expertise. 3. The applicant must have ability to assist in designing protocols and the data collection system. 4. Experience in developing and monitoring quality control shall be demonstrated. 5. The Data Coordinating Center will report to the Data Safety and Monitoring Committee at least every six months regarding accumulating data and the RMUs' performance. The application should document ability to meet such reporting deadlines as well as the overall timetable. 6. The applicant must be prepared to cooperate with the RMUs and NICHD staff in all design, collection, and analysis functions. 7. The application must include a plan detailing methods of data receipt, analysis, quality control, and reporting, including communications with administrative and clinical personnel. 8. If an institution applies for both RMU and DCC, the DCC application must address the issue of how the DCC would maintain operational independence if both were funded. For the DCC as for the RMUs, access to and familiarity with a network such as BITNET or Internet is desirable. Budget Preparation The instructions for budget estimates provided with the Research Grant application form (PHS 398) should be followed. Indirect 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 including estimates of staffing needs. Since the details of study requirements will not be known at the time of application, however, it is understood that requested budgets will be estimates. Therefore, funding levels will be subject to negotiation between the grantee institutions and the NICHD prior to awarding funds. In the first year, support should be requested for the principal investigators to travel to meetings required for initial activities: joint identification of topics, the development of protocols, and the design of data gathering instruments. The first year budget should also request partial year support for new protocol start-up costs, to begin after the initial tasks, above, have been completed, as well as completion of studies that may have been approved during 1994 or 1995. A composite for all these activities might include the following: a full-time research nurse/study coordinator, fractional-time senior investigator, fractional-time data clerk, fractional-time technician, clinical testing expenses, travel expenses covering four meetings in Bethesda, Maryland for the principal investigator, one trip each for nurse coordinator and technician training, and justifiable supplies and "other" expenses. The budget proposal for future years, should, at this time, present estimated costs of participating in a study such as the proposed "concept" protocol, including personnel costs similar to the first year, plus recruitment costs and travel for the principal investigator to three Steering Committee meetings per year in Bethesda. Terms and Conditions of Award The following terms and conditions of the award, and details of arbitration procedures pertaining to the scope and nature of the interaction between NICHD and the participating RMUs and Data Coordinating Center, will be incorporated into the Notice of Grant Award and provided to the Principal Investigator as well as the institutional official at the time of award. These procedures will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. 1. The purpose of these Agreements is to facilitate resolution of problems in adult reproductive medicine by establishing a network of units (Reproductive Medicine Units and a Data Coordinating Center) able to study large numbers of patients and provide conclusions more rapidly than institutions acting alone. 2. Planning and implementation of the study will by done by a Steering Committee consisting of the principal investigator from each participating unit, a Program Officer from the Reproductive Sciences Branch, CPR, NICHD, serving as Research Coordinator; with a nongovernment chairperson designated by the Steering Committee. A member of the NICHD grants management staff will serve as advisor to the Committee. 3. Primary authorities and responsibilities of the awardees: o Define objectives and approaches; o Plan the design and implementation of the protocols; o Conduct the studies; o Collect and analyze the data; o Publish the results, conclusions and interpretations of studies. o Modify, delete or add protocols, subject to NICHD approval, when a new protocol would constitute a major change in scope. Awardees will retain custody of and primary rights to their data developed under the award, subject to current Government policies regarding rights of access. The awardees agree to accept the coordinating role of the Steering Committee and the cooperative nature of the group process. 4. The degree of programmatic involvement by NICHD staff: o Assist in and facilitate the development of study protocols; o As a member of the Steering Committee, review and comment on each stage of the program before subsequent stages are started, including options of modification or termination by mutual consent between the Network and NICHD; o Assist in maximizing cooperation among the units, and help redirect efforts, if necessary; o Retain the option to withhold support of a participating unit, if technical performance requirements such as compliance with the protocol, meeting patient enrollment targets, and adherence to uniform data format are not met. Support will be contingent upon meeting these requirements. Alternatively, determine jointly with the awardees, the need to add clinical sites for the purpose of increasing patient accrual. o Assist, through review, comment, analysis and, where appropriate, co- authorship, in reporting results to the community of investigators and health care recipients. 5. 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 investigators, one person selected by NICHD staff, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. 6. Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. The above special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on HHS regulations at 45 CFR Part 74 and 92. Business management aspects of these awards will be administered by the NICHD Grants Management section in accordance with HHS, PHS, and NIH grant administration requirements. STUDY POPULATIONS 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 is 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 9, 1994 (FR 59 11146-11151) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. (NOTE: When the proposed study or studies in the RFA or PA involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform potential applicants and reviewers.) LETTER OF INTENT Prospective applicants are asked to submit, by May 1, 1994, 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 the RFA in 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 subsequent applications, the information that it contains allows NICHD staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Donna L. Vogel at the address listed under INQUIRIES. APPLICATION PROCEDURES All applicants must document their ability to meet or exceed the minimum requirements as set out in the SPECIAL REQUIREMENTS section for RMU or DCC applications as detailed above. This specifically includes understanding of and commitment to the cooperative nature of this program. If an applicant institution elects to submit applications for both an RMU and the DCC, they must be separate applications, appropriately labeled, with different personnel, and separate budgets. Any competing renewal application should include in the progress report a description of how the site has met the special cooperative agreement terms and conditions of the award, including its interaction with other Network sites and the NICHD Research Coordinator. Applications 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 appropriate. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these awards. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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, COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK, and number, RFA HD-94-016, must be typed on line 2a 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: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Susan Streufert, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Building 61E, Room 5E03 Bethesda, MD 20892 Applications must be received by July 19, 1994. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (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 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. Schedule Letter of Intent Receipt Date: May 1, 1994 Application Receipt Date: July 19, 1994 Initial Review Group Peer Review: October/November 1994 NACHHD Council Review: January 31, 1995 Earliest Award Date: April 1, 1995 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness by NIH staff. Incomplete applications will be returned to the applicant without further consideration. Any application that does not meet the minimum requirements of this RFA will be considered unresponsive to the RFA and returned to the applicant. Applications meeting the minimum requirements will be reviewed as a group on a competitive basis with each other and in accordance with the usual NIH peer review procedures for research grants. Applications may receive a preliminary scientific peer review (triage) by an NICHD peer review group to determine their relative competitiveness. The NIH will withdraw from further competition those applications judged to be noncompetitive for award and notify the applicant Principal Investigator and institutional official. Those applications that are complete and responsive, and judged to be competitive in triage (if used), will undergo further scientific merit review in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened specifically for this purpose by the Division of Scientific Review, NICHD. The second level of review will be provided by the National Advisory Child Health and Human Development Council. 1. Criteria for Review of Clinical RMU Applications: a. Qualifications, Experience, and Commitment of Key Personnel o Scientific, clinical, and administrative abilities of the principal investigator and other team members; o Knowledge and experience in areas relevant to the conduct of potential studies utilizing clinical and laboratory evaluation of patients with reproductive disorders; o Commitment of staff time for the satisfactory conduct of the study; o Experience and qualifications of team members who would be responsible for internal coordination of data management. b. Protocols and Procedures o Responsiveness of the application to the objectives of the study as outlined in this RFA; o Willingness to work and cooperate with other RMUs and the NICHD in the manner summarized in this RFA; o Quality of the proposed "concept" protocol designed to be undertaken by the Network, including ethical issues relating to human subjects, and separately, appropriate inclusion of women and minorities as subjects. c. Facilities and Management o Adequacy of administrative, clinical, and data organizational management facilities as described in the minimum requirements. o Institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning and budgeting. 2. Criteria for Review of Data Coordinating Center a. Qualifications, Experience, and Commitment of Key Personnel o Scientific and administrative abilities of the principal investigator and other team members. o Experience of the principal investigator and other key personnel in statistical, data management, quality control, study coordination, and administrative aspects of multicenter clinical studies. o Commitment of staff time for satisfactory conduct of the study. o Understanding of the scientific objectives and design of the program, as evidenced by discussion of design, recruitment and implementation issues. b. Protocols and Procedures o Proposed data collection and monitoring system. o Discussion of ability to meet proposed timetable. o Willingness to work cooperatively with the RMUs and the NICHD, in the manner summarized in this RFA. c. Facilities and Management o Satisfactory facilities and supporting environment, including space and equipment for the work proposed (any new equipment requested under this award must be strongly justified). o Evidence of institutional support for participation in a long-term collaborative program. AWARD CRITERIA The anticipated date of award is April 1, 1995. Applications recommended by the NACHHD Council will be considered for award based on scientific and technical merit; program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Donna L. Vogel, M.D., Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Building 61E, Room 8B01 Bethesda, MD 20892 Telephone: (301) 496-6515 FAX: (301) 496-0962 Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson Office of Grants and Contracts National Institute of Child Health and Human Development Building 61E, Room 8B17 Bethesda, MD 20892 Telephone: (301) 496-5481 FAX: (301) 402-0915 AUTHORITY AND REGULATIONS This Program is described in the Catalog of Federal Domestic Assistance number 13.864, Population Research. Awards will be made under the authority of the Public Health Service Act, Title X, Section 1004 (Public Law 92-572, as amended; 42 USC 241) and Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241). 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 Part 74, and other HHS, PHS, and NIH grant administration policies. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the american people. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |