Full Text HD-92-09 REPRODUCTIVE FUNCTION IN PEOPLE WITH PHYSICAL DISABILITIES NIH GUIDE, Volume 21, Number 7, February 21, 1992 RFA: HD-92-09 P.T. 34 Keywords: Human Reproduction/Fertility Rehabilitation/Therapy, Physical Neuroscience National Institute of Child Health and Human Development (NICHD) Application Receipt Date: May 22, l992 PURPOSE The National Center for Medical Rehabilitation Research (NCMRR) of the National Institute of Child Health and Human Development (NICHD) invites research grant applications to develop new knowledge in the areas of reproductive physiology, anatomy, and behavior that are common to people with disabilities. The goal of this Request for Applications (RFA) is to restore, improve, and enhance reproductive function lost as a consequence of injury, disease, and congenital disorder. Basic, clinical, and applied research applications that address these areas are of high priority. Interdisciplinary collaborative projects are also encouraged that focus studies of human sexual functioning and reproductive behavior on the development of interventions and devices that will improve the quality of life in people with physical disabilities. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention goals of "Healthy People 2000," a PHS-led national activity for setting priorities. This RFA, Reproductive Function in People with Physical Disabilities, is related to the priority areas of nutrition, physical activity and fitness, heart disease and stroke, cancer, and diabetes and chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-474-0, or 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 public and private, non-profit and for-profit organizations such as universities, colleges, hospitals, laboratories, units of state local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) individual research grant (R01). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Project support may be requested for one to five years and may be renewed according to the conventional procedures that pertain to PHS grants. The earliest anticipated award date will be September 1992. 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 NIH peer review procedures. FUNDS AVAILABLE Applications submitted in response to this announcement will compete for approximately $800,000 in grant money that has been made available for this purpose in Fiscal Year l992. It is expected that four awards will be made. The number of awards depends upon the overall scientific merit of the applications and the availability of funds. RESEARCH OBJECTIVES Background On November 16, l990, the President signed Public Law 101-613, establishing a National Center for Medical Rehabilitation Research within the National Institute of Child Health and Human Development. The mandate of the NCMRR is to conduct and support research that focuses on health-related improvement in human functioning at the pathophysiological, physical impairment, functional impairment, disability, and societal impact levels. A task force of more than 100 clinicians and researchers with expertise in a wide range of medical, biological, allied health, and social sciences was convened in 1990 to assess medical rehabilitation research. These experts conducted a sweeping survey of research needs, challenges, and opportunities in rehabilitation medicine (Report of the Task Force on Medical Rehabilitation Research, l990). Research on the improvement of reproductive function in people with physical disabilities was identified as a priority. In response to this recommendation the NICHD organized a conference on Reproductive Issues for Persons with Physical Disabilities. This RFA will implement the recommendations of both panels concerning research on improvement of reproductive function in people with physical disabilities Scope Advances in medical care have resulted in a longer life expectancy and greater integration into society of people with physical disabilities. High percentages of men and women with physical disabilities, such as traumatic brain injury and spinal cord injury, are in the prime reproductive years. These individuals now lead independent lives and may wish to establish successful personal relationships and have children. At the same time, major advances have been made in reproductive technology and improvement in the management of high-risk pregnancies enabling individuals to conceive and bear children who, a few years ago, would have been considered infertile. These medical advances in the reproductive sciences along with the mainstreaming of people with physical disabilities now provide an opportunity for focusing research on improving reproductive success in persons with disabling conditions. This RFA invites scientists to submit grant applications for research into the re-establishment, improvement, and management of reproductive function in people with physical disabilities. Little research has been done on the needs of individuals with disabling conditions in regard to their ability to establish successful intimate relationships, conceive, bear, and parent children due to societal perception of the reproductive needs of persons with disabilities. Research is needed in the areas of sexual identity among children with disabilities, physiological and behavioral changes in sexual function as a result of the disabling process, obstetrical care, and parenting issues. Research applications are solicited that will address basic, clinical, and applied research into the improvement of reproductive outcome and that will improve the quality of life for people with disabling conditions. The list of research areas cited below is representative, though not exhaustive, of the topics solicited by this announcement and serves as a guide for potential applications submitted for this RFA. o characterize the effects of different types and locations of head and spinal cord trauma on sexual function and reproduction o define neuronal populations responsible for the modification of the sexual response in individuals with disabling conditions o develop neural, hormonal, or pharmacological interventions to enhance or restore sensory and motor function involved in the sexual response o characterize and define the causes of secondary complications in sexual functioning associated with spinal cord injuries and traumatic brain injury o characterize long-term posttraumatic changes that reduce fertility in men and women with disabilities o identify physical and behavioral factors associated with successful prosthetic use and effectiveness with prosthetic fitting o investigate methods for the improvement of yield in protocols requiring repeated collection of semen by electroejaculation and its effect on the well-being of men with disabilities o examine the effects of immobility and the compromised autonomic nervous system on the vascular system, bioavailability of medications, and endocrine regulation and how these affect fertility and the production of viable gametes o identify the cause of autonomic dysreflexia in spinal cord- injured men and women and develop intervention strategies to reduce its incidence during sexual behavior and during pregnancy and delivery o evaluate changes in the menstrual cycle and in the sexual response in women immediately post-injury and longitudinal studies in order to develop appropriate intervention strategies and to assess their efficacy o characterize the best means of management of pregnant women with spina bifida, spinal cord injury, multiple sclerosis, and other disabilities and identify clinical issues that are unique to these women o characterize the effect of impairment of sexual function on psychosocial adaptation, emotional state, and establishment of intimate relationships o identify the processes associated with gender identity in children with disabilities such as spina bifida, cerebral palsy, muscular dystrophy, and spinal cord injury o examine both the immediate and long-term changes in sexual behavior after traumatic brain injury STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS National Institutes of Health (NIH) policy is that applicants for NIH clinical research grants will be 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 should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that 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 should be provided. The composition of the proposed study population must be described in terms of gender and racial or ethnic group together with a rationale for its choice. In addition gender and racial or ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included on the grant application form PHS 398 in Section 2, A-D of the research plan and summarized in Section 2, E, (Human Subjects). Applicants are urged to carefully assess 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 or ethnic minority populations (i. e., Native Americans (including American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, Hispanics). The rationale for limiting studies to one minority population group should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies on 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 tissue 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, applicants must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. 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 will be reflected in assigning the priority score to the application. 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. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91). This application form is available in the business or grants and contracts office at most academic and research institutions and from the Office of Grants Inquiries, Division of Research Grants, NIH, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. The receipt deadline for applications prepared in response to this RFA is May 22, l992. Late applications will be returned to the applicant. This is a one-time announcement. The RFA label available in the PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application in that it may not reach the review committee in time for evaluation. Check "yes" in line 2 on the face page of the application and type "Reproductive Function in People with Physical Disabilities, RFA HD-92-09." The original and four copies of the application must be sent or delivered to: DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** In addition, two copies of the application must be sent under separate cover to: Laurance Johnston, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development Executive Plaza North, Room 520 Bethesda, MD 20892 REVIEW CONSIDERATIONS Applications will be reviewed by staff of the NICHD for responsiveness to the RFA. Applications deemed non-responsive will be returned to the applicant. If an application is returned, the applicant has the option to resubmit the application to the Division of Research Grants as an unsolicited application during one of the three yearly review cycles (February 1, June 1, and October 1). If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been 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. Responsive applications may be evaluated by a preliminary triage in a peer review group to determine scientific merit relative to other applications received in connection with this RFA. Applications judged to be non- competitive will be withdrawn and the Principal Investigator and his/her institutional business official will be notified in such instances. Those applications judged to be competitive will be further evaluated for technical and scientific merit by a review panel convened for this purpose by the Division of Scientific Review, NICHD. Review criteria will be those used by NIH to evaluate investigator-initiated individual research grant applications, including: o Thorough knowledge of scientific literature in appropriate fields 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, particularly but not exclusively in the area of the proposed research o Availability of resources necessary to perform the research o Appropriateness of the proposed budget and duration in relation to the proposed research The second level of review will be by the NICHD National Advisory Council. AWARD CRITERIA The anticipated date of award is September 1992. Awards will be made on the basis of the quality of the proposed project as determined by peer review, program balance among research areas, and level of funding set aside for this RFA. INQUIRIES Requests for additional information and descriptions of proposed research projects may be addressed to: Danuta Krotoski, Ph.D. Chief, Basic Rehabilitation Medicine Research Branch National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Executive Plaza South, Room 450W 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 402-2242 For fiscal and administrative inquires regarding this announcement, potential applicants may write or call: E. Douglas Shawver Office of Grants and Contracts National Institute of Child Health and Human Development Executive Plaza North, Room 501 6130 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.929, Medical Rehabilitation 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. .
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. |