Full Text HD-94-015 IDIOPATHIC MALE INFERTILITY NIH GUIDE, Volume 23, Number 8, February 25, 1994 RFA: HD-94-015 P.T. 34 Keywords: Human Reproduction/Fertility Urogenital System National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 8, 1994 Application Receipt Date: May 18, 1994 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites research grant applications for the support of investigations comprising basic and clinical research on the etiology and pathophysiology of infertility in the otherwise normal male. Report language accompanying the House of Representatives 1994 appropriations bill encouraged NICHD to expand research activities in male infertility. 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), Idiopathic Male Infertility, 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 and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. Applications from minority individuals, persons with disabilities, and women are encouraged. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research project grant (R01) and FIRST (R29) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest expected award date is December 1, 1994. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE It is expected that up to four new awards will be funded, within the total direct cost limit of $800,000 available for the first year. This level of support is dependent of the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Infertility affects millions of United States couples, and the female partner is apparently normal in some 60 percent of those couples affected. Where infertility is attributed to a male factor, it is unusual to make a clear diagnosis of an explanatory condition, such as hypogonadism or obstruction within the male genital tract. Thus, it is rare that treatment can be directed at an established cause in the male. More often, the male is well virilized and clinically normal, but has a gross or subtle abnormality in sperm function. Infertility treatment in these cases is typically in the form of ovulation induction and/or assisted reproductive technology. In cases where ovulation induction is successful, it could be deduced, retrospectively, that a subtle ovulation defect had been, in fact, treated. Usually, however, these techniques are applied empirically in hopes of maximizing chances to conceive. Thus, there is a need for basic and clinical research on the causes of infertility in the apparently normal male. The anticipated benefits of this research are development of a sound scientific basis for treatment choices, as well as prospects of new treatments for male infertility. Objectives The overall objective of this RFA is to support and encourage research on the etiology and pathophysiology of infertility in men who are otherwise clinically normal, that is, have no evidence of a treatable cause for their infertility such as hypogonadism or obstruction. The long term goals of such research would be to delineate diagnostic subcategories within this group of men that would provide meaningful guidance for choice of treatment, and also provide research leads for the development of new treatments for male infertility. Laboratory research using human cells and tissues, and clinical research in human subjects, are invited under this RFA. Animal models will also be considered relevant if they can be justified as being applicable to human infertility. There is controversy in the field regarding the relationship of varicocele to infertility, and specifically regarding the potential benefits of varicocelectomy. For purposes of this RFA, men who remain infertile following correction of varicocele(s) may be considered among the idiopathic group if they are otherwise eligible. Examples of topics appropriate for this RFA might include, but not be limited to: o Subtle sperm function defects not being detected with existing methods; o Effects on fertility of immune sequelae following transient insult, e.g., postinfectious, postinflammatory, posttraumatic; o Physiological insult resulting in testicular dysfunction and subsequent impaired spermatogenesis; o Defective sperm-egg interaction; o Genetic abnormality manifested as early embryo loss. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. For the purpose of this RFA, these requirements must be addressed even if the nature of the research is such that only male subjects are involved. An explanation that the condition under investigation only affects males will be acceptable regarding the policy on inclusion of women. An estimate of the number or percentage of minority subjects participating or providing samples in the proposed research, with a justification if these numbers are low relative to the general population, is generally sufficient to comply with the requirements on inclusion of minorities. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by April 8, 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 The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westward 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 and number must be typed on line 2a of the face page of the application form and the YES box must be marked. 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 appropriate. If so, a letter of agreement from either the GCRC program director or Principal Investigator could be included with the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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 May 18, 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 announcement 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by DRG staff for completeness and by NICHD staff for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, it will be returned to the applicant, who may then submit it for review in competition with unsolicited applications at the next available review cycle. Responsive applications may be triaged by a 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 judged to be competitive will undergo further evaluation for scientific merit. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NICHD. The second level of review will be provided by the National Advisory Child Health and Human Development (NACHHD) Council. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. o Scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, and of collaborators, if applicable; o adequacy of time and effort dedicated to the project; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA The earliest anticipated date of award is December 1, 1994. Funding decisions will be based on peer review and NACHHD Council recommendations, program relevance, and availability of funds. In some cases, if the proposed research has relevance to the research program of another NIH Institute as well as that of the NICHD, the application may be dually assigned to and considered for funding by that Institute. Any such assignment will be made according to existing DRG referral guidelines and independently of peer review procedures. 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 to: Donna L. Vogel, M.D., Ph.D. Center for Population Research 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 No. 93.864, Population Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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