RESTITUTION OF AMBULATION FOLLOWING DISABILITY FROM NEUROLOGICALDISORDERS NIH Guide, Volume 22, Number 17, April 30, 1993 PA NUMBER: PA-93-079 P.T. 34 Keywords: Rehabilitation/Therapy, Physical Neurological Disorders Injury Nervous System National Institute of Neurological Disorders and Stroke National Institute of Child Health and Human Development PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Child Health and Human Development (NICHD), invite research grant applications for support of research on the restitution of ambulation following disability from neurological disorders or injury. Applications covering a broad range of activities in the neurological sciences from clinical research to fundamental neuroscience research are encouraged. Regardless of approach, all proposed research activities should share the common theme of restoring ambulatory function in the presence of dysfunction of the central or peripheral nervous system. This type of solicitation is issued to encourage investigator-initiated research projects in areas of special programmatic interest to the National Institutes of Health (NIH). 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), Restitution of Ambulation Following Disability From Neurological Disorders, is related to the priority area of chronic disabling conditions. 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, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible to apply for career awards (K04, K08) or First Independent Research Support and Transition (FIRST) (R29) awards and program projects (P01). Applicants for K04 and K08 awards must be U.S. citizens or resident aliens. MECHANISM OF SUPPORT The support mechanisms for this research will be the individual research grant (RO1), the FIRST award (R29), Research Career Development Award (K04), Clinical Investigator Award (K08), and the program project grant (P01). The number of awards to be made is dependent upon receipt of a sufficient number of applications of high scientific merit and upon availability of funds. RESEARCH OBJECTIVES Summary The NINDS is the principal NIH component for support of basic and clinical research on neurological disorders and their prevention, diagnosis, treatment, and rehabilitation. The National Center for Medical Rehabilitation Research at the NICHD serves as the principal NIH focus of research support that will lead to new approaches for the replacement, enhancement or restoration of function in persons with physical disabilities resulting from birth defect, injury, disease or the aging process. Because of a lack of effective restorative therapies, the clinical approach to rehabilitation has often focused on substitution. For example, a walker or wheel chair can substitute for inadequate lower extremity muscle strength or control. This PA encourages research directed at rehabilitation through restitution or enhancement of function in patients disabled by neurological disorders or by injury to the nervous system during both the acute and chronic phases. Disability in the form of a loss of the ability to ambulate can follow many common neurological and neuromuscular diseases and disorders or traumatic injuries. For example, approximately 250,000 persons are disabled by stroke in the United States each year. Many of these individuals are either unable to walk or walk with great difficulty as a result of inadequate or untimely muscle activity. Other individuals suffering from spinal cord injury, head injury, cerebral palsy, Parkinson's disease, multiple sclerosis, and other neurological conditions are similarly affected. Achieving the goal of rehabilitation through restitution or improvement of function in patients disabled by neurological disorders will require fundamental and applied research in many areas. Potential areas of research include motor control, sensory systems in motor control, ambulation, postural control as it relates to gait, and activation, conditioning and control of weakened or paralyzed muscles. This PA is issued to encourage grant applications that cover a range of investigative approaches from basic neurosciences to feasibility studies of potential clinical applications. Goals This PA is issued to encourage and foster investigator-initiated applied, basic, and clinical research on restoration of ambulation following neurological disability. Although specific neurological diseases and disorders are not mentioned in this section, potential applicants are encouraged to focus their effort in the context of a specific disorder. Examples of research objectives appropriate for inclusion in applications responsive to this program announcement include: o Applied research directed at improving or restoring ambulatory motor function in neurologically impaired individuals; o Applied research directed at improving or restoring cutaneous sensation and proprioception related to ambulation in neurologically impaired individuals; o Fundamental studies of the neurophysiological foundation of the control of ambulation and its pathology; o Fundamental studies of the neurophysiological foundation of cutaneous sensation and proprioception, their pathology and their role in ambulation; o Studies of the integration of biomechanics and the motor, sensory and central nervous systems in gait, standing, and in postural control; o Fundamental and applied studies that will characterize the capacity of both injured and non-injured systems to contribute to the recovery of ambulatory function; and o More accurate and sensitive methods for quantifying functional impairments after neurological injury or disorder. 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 should 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 must 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 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 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) and will be accepted on any of the three receipt dates for research grant applications, February 1, June 1, and October 1. Application kits are available at most offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 710-0267. The title and number of the announcement must be typed in Section 2a on the face page of the application. The original and five 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** REVIEW PROCEDURES Applications will receive institute and initial review group (IRG) assignment on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit according to standard PHS referral guidelines. Following IRG review, the applications will receive a second-level review by an appropriate Council/Board. Applications will compete for available funds with all other approved applications assigned to the institute. REVIEW CRITERIA The standard review criteria will be used to assess the scientific merit of applications. The IRG will be reviewing the adequacy of protection of human subjects, the humane care of animals, and biosafety conditions. In clinical research studies, reviewers also will be evaluating the adequacy of the inclusion of women and minorities in the study populations. AWARD CRITERIA Applications will compete for available funds with all other applications. 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 of the announcement INQUIRIES Written and telephone inquiries are encourages. the opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. William Heetderks Division of Fundamental Neurosciences National Institute of Neurological Disorders and Stroke Federal Building, Room 916 Bethesda, MD 20892 Telephone: (301) 496-5745 Internet: [email protected] Dr. Danuta Krotoski National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Executive Plaza North, Room 450 Bethesda, MD 20892 Telephone: (301) 402-2242 Bitnet: d2k@NIHCU For fiscal and administrative matters contact: Ms. Kathleen Howe National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17F Bethesda, 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, 93.854 - Biological Basis Research in Neurosciences, and 93.853 - Clinical Research related to Neurological Disorders. Grants will be awarded under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or a Health Systems Agency review. .
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