NEURAL REGENERATION AND PLASTICITY AFTER SPINAL CORD INJURY NIH GUIDE, Volume 21, Number 41, November 13, 1992 PA: PA-93-018 P.T. 34 Keywords: Injury Nervous System Neuroscience Gene Products National Institute of Neurological Disorders and Stroke PURPOSE The Division of Stroke and Trauma (DST), National Institute of Neurological Disorders and Stroke (NINDS), invites applications for support of research that will increase our knowledge of the mechanisms underlying the neuronal regeneration and plasticity that can follow spinal cord injury. 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 Program Announcement (PA), Neural Regeneration and Plasticity after Spinal Cord Trauma, is related to the priority area of unintentional injuries: spinal cord injury. 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 foreign and domestic institutions, 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. Applications from minority institutions, minority individuals, and women are particularly encouraged. MECHANISMS OF SUPPORT The support mechanism for grants in this area will be the traditional investigator-initiated research project grant (R01). The Principal Investigator will plan, direct, and, along with any co-investigators, perform the research. Applicants are encouraged to contact the NINDS representative listed below as early as possible in the planning stages. RESEARCH OBJECTIVES Background Injury to the spinal cord tragically affects hundreds of thousands of victims in the United States, with approximately 10,000 new traumatic injuries each year. Early treatment and improved hospital care have increased survival, but at great cost. The estimated yearly cost of long term, specialized care for paralyzed patients exceeds $2 billion. The personal costs to patients and their families is beyond calculation: planned education, career, marriage, and independence are interrupted and often never regained. The spinal cord, as part of the central nervous system (CNS), coordinates movement and sensation for the entire body below the head. Specialized cell populations within the cord are the substrates for these functions. Large motoneurons extend long axons peripherally to innervate skeletal muscle. Extensive arborizations of these motoneurons receive information via descending tracts from the brain. The long fibers of dorsal root ganglion cells connect peripheral sensory receptors to spinal interneurons, to motoneurons, and to brain centers. This complex neuronal circuitry of the spinal cord is supported by the glia of the CNS. Radial glia enclose the cord like the rim and spokes of a wheel, defining compartments for ascending and descending fiber systems. Astrocytes contribute to the blood-spinal cord barrier and provide a wide variety of support functions. Oligodendrocytes myelinate axons. Traumatic injury disrupts all of these cell types and changes their functions. Axons degenerate, neurons die, astrocytes proliferate and become reactive, radial glia enclose large cysts, and oligodendrocytes cannot remyelinate damaged areas. The anatomy of an injured spinal cord shows profound pathology, but also reveals the sprouting of uninjured fibers, the regeneration of damaged populations, the reorganization of glia, and clearing away of debris. Enhancement of these beginnings of regeneration and reorganization is necessary. Several trophic factors are known to affect survival of neurons and extension of neurites. Likewise, naturally occurring substances may enhance supportive glial functions. Components of the extracellular matrix can support the growth of axons. The growing knowledge of cellular mechanisms of repair within the injured spinal cord offers the hope of treatment for this devastating disorder. Research Goals and Scope Examples of investigator-initiated research grant applications for basic, applied, and clinical studies related to the understanding and enhancement of regeneration in the injured spinal cord may include, but should not necessarily be limited to: o identification of the tissues, cells, and substrates critical to the regenerative process; o behavioral, chemical, functional, and structural correlates of restored or remodeled neural circuits; o gene and protein expression in neurons and support cells during regeneration; o development of cellular transplants to augment or support regeneration, restore lost function, or replace damaged cells; o immune responses to implants of neural tissues, cell lines, or cellular products; and o pharmacological or biochemical approaches to prolong or enhance regeneration. Applicants are encouraged to develop and use new or refined methodologies, instrumentation, and procedures that will reveal mechanistic details of the regenerative process. Basic, applied, or clinical studies on interventions or manipulations to improve regrowth of fibers, prevent pathophysiological changes, or aid in functional recovery are welcome. 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 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. 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 in the form PHS 398 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, the NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of Unites States racial or ethnic minority populations: Native Americans (including American Indians or Alaska Natives), Asian or Pacific Islanders, Blacks, and Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and prevention 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 or ethnic minorities when it is important to apply the results of the study broadly. This directive 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 review will be deferred until the information is provided. 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 the NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) according to the instructions included in the application package. These application packages are available at the business offices of most institutions eligible to receive Federal grants and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. Receipt dates for new research project grant applications (R01) are February 1, June 1, and October 1. On page 1 of form PHS 398, check "yes" in Item 2a, enter the number of this Program Announcement in the space provided, and provide the name of this Program Announcement, Neural Regeneration and Plasticity after Spinal Cord Injury in the blank space labeled "Title." Use the mailing label provided in the application package to mail the signed original and five exact copies of it to: Division of Research Grants. National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. The second level of review will be by the appropriate national advisory council. The standard review criteria will be used to assess the scientific merit of applications. AWARD CRITERIA Applications will compete for available funds with other applications assigned to an Institute or Center. The following will be considered when making funding decisions: o quality of the proposed projects as determined by peer review o availability of funds o program balance among research areas. INQUIRIES Questions concerning scientific aspects of this Program Announcement may be addressed to: Dr. Mary Ellen Michel Division of Stroke and Trauma National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Questions concerning fiscal aspects of this Program Announcement may be addressed to: Mr. King P. Bond, Jr. Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.853, Clinical Research Related to Neurological Disorders, and No. 93.854, Biological Basis Research in the Neurosciences. Grants will be awarded under the authority of the Public Health Service Act, Title IV, Section 301 (Public Law 78-410, as amended: 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR 74. This program is not subject to Health Services Agency Review of the intergovernmental review requirements of Executive Order 12372. .
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