MEDICAL REHABILITATION RESEARCH Release Date: January 20, 1999 PA NUMBER: PA-99-041 P.T. National Institute of Child Health and Human Development THIS PROGRAM ANNOUNCEMENT REPLACES PA-92-042, WHICH WAS PUBLISHED IN NIH GUIDE, VOL. 21, NO. 7, FEBRUARY 21, 1992 PURPOSE The National Center for Medical Rehabilitation Research (NCMRR) of the National Institute of Child Health and Human Development (NICHD) invites qualified researchers to submit grant applications for research on restoring, replacing, or enhancing the function of adults and children with disabilities. Medical rehabilitation research is directed towards restoration and improvement of functional capability lost as a consequence of injury, disease, or congenital disorders. The mission of the NCMRR is to increase the effectiveness of medical rehabilitation practices through research on: (1) improving functional mobility, (2) promoting behavioral adaptation to functional losses, (3) assessing the efficacy and outcomes of medical rehabilitation therapies and practices, (4) developing improved assistive technology, (5) understanding whole body system responses to physical impairments and functional changes, (6) developing more precise methods to measure impairments, disabilities, and societal and functional limitations, and (7) training research scientists in the field of medical rehabilitation. Medical rehabilitation research concerns the scientific acquisition of knowledge about potential or existing interventions that have the goal of maximizing the health-related functioning of people with conditions associated with disabilities. Interventions concerned with the life-long maintenance and promotion of the health of people with disabilities are a part of this goal. Relevant research includes basic science studies related to the pathophysiologic mechanisms and processes underlying functional loss; likewise, changes in these underlying mechanisms during and following rehabilitative interventions are highly relevant. Basic, applied, and clinical research on the adaptive and maladaptive behavioral responses to physical impairments and functional changes are important components of medical rehabilitation research. Studies of assisted recovery from or adaptation to functional losses are conducted by researchers from a wide variety of professions such as physical medicine and rehabilitation (physiatry), neurology, pediatrics, urology, orthopedics, neurosurgery, rheumatology, nursing, physical therapy, occupational therapy, speech and language pathology, engineering, psychology, sociology, and epidemiology. Physiology, developmental biology, neuroscience, cell biology, materials science, computer science, and other basic science disciplines contribute to understanding mechanisms and processes fundamental to functional recovery. Interdisciplinary research is needed and encouraged. 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, Medical Rehabilitation Research, 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" at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Applications for research project grants (R01) 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 or local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for the R03 mechanism. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms of support available for applications submitted in response to this program announcement are research project grants (R01) and the NICHD Small Grant (R03). Potential applicants are encouraged to contact staff listed under INQUIRIES or visit the NCMRR home page at http://silk.nih.gov/silk/NCMRR/ for information on the NICHD Small Grant Program. In addition to the R01 and R03 grants, NCMRR funds several other research and research training grant mechanisms. RESEARCH OBJECTIVES Background Approximately 49 million Americans have a disability (Brandt and Pope, 1997). Almost four percent of the U.S. population is unable to carry out the major activity of their age group (e.g. personal care, work, school) because of severe disabilities. An additional six percent of the population are restricted in their major activities, and another four percent are limited in other types of activity (e.g. recreation, social pursuits). The NCMRR provides an opportunity for scientists to conduct research on the functional changes that result from illness, injuries, or congenital conditions whose influence may continue throughout life. The emphasis is on health-related improvement in human functioning at the pathophysiological, physical impairment, functional limitation, disability, and societal impact levels of analysis. Explicitly included are studies of the application of new knowledge to the development of medical, behavioral, psychological, social, and technological interventions designed to optimize functioning after impairment. Research interests extend from the molecular level to the functioning of individuals in their physical and social environments. Scope The NCMRR seeks applications for support of research projects in disciplines related to medical rehabilitation. Many research issues fall within the scope of this announcement. Understanding the medical rehabilitation process requires knowledge of the pathophysiology of physical impairment, the functional limitations that arise, the personal and behavioral aspects of specific disabilities, and the impacts of societal limitations. Basic, clinical, and applied research is encouraged, embodying a wide variety of approaches. Clinical trials of specific rehabilitation strategies are highly relevant. The following sections describe examples of appropriate topics for research within the existing NCMRR programs. Behavioral Science and Rehabilitative Engineering Program Behavioral and Social Science Interventions. This program area is concerned with potential or existing behavioral or social science interventions that maximize the health-related functioning of people with conditions associated with disabilities. Studies examining interrelationships among health, behavior, and disability are encouraged. Clinical research examining relationships between environmental factors and behavioral adaptation to chronically disabling physical conditions is welcomed as well. Examples of relevant research include, but are not limited to: o Basic studies examining intrapersonal (e.g. perceptual-motor, cognitive or emotional) changes that occur while people with physical disabilities perform particular tasks in specific environments; o Studies delineating environmental factors (physical, familial, social, or cultural) that influence behavioral adaptation to disability; o Development and evaluation of interventions (e.g., training in self-care skills or health maintenance techniques) to promote adaptation; and o Methodological or measurement-oriented studies pertinent to issues highlighted above. Rehabilitation Engineering. This program area emphasizes the role of biomedical engineering in the rehabilitation process by supporting research that pertains to restoration of functioning or substitution for functional losses. Biomedical engineers draw from the knowledge base of many of the life and physical sciences and apply this knowledge to developing meaningful applications that improve a person's physical and mental functioning and their contributions to society. Examples of research topics include, but are not limited to: o Development of orthotic and prosthetic devices as well as technologies that facilitate sensory functioning, communication, or control of their physical environment; o Research to characterize and assess functional loss in chronic disabling conditions; and o Development of new strategies to restore functioning or to substitute for functional losses. Biological Sciences and Career Development Program Biological Sciences. Research on the biological mechanisms that underlie disabling conditions may suggest new rehabilitation treatments to reverse or overcome the impairments present in disabling conditions. In addition, existing rehabilitation strategies have biological consequences, that need to be understood more fully. Research areas include, but are not limited to: o Animal models of chronic disabling conditions; o Neuroplastic responses to chronic injury or disease; o Endocrine changes that accompany long-term disorders; o Immune function in primary and secondary disabling disorders; o Secondary impairments that result from primary disabling conditions and prevention of such impairments; o Strategies for repairing or replacing lost organ/tissue function, including use of implanted tissues, cell lines, stem cells, biomaterials, and in vitro models; o Imaging of chronically injured or impaired organ systems; and o Interactions among organ and tissue systems in disability. Career Development. Research training and career development are critical for the growth of medical rehabilitation research. The NCMRR is committed to increasing the number of active researchers in medical rehabilitation and to expanding the scope of research disciplines that are brought to bear on the field. Several mechanisms for support are offered that allow persons at all levels of their academic careers to be mentored in research related to improving the functional capacity of individuals with disabling conditions. Training opportunities exist for persons with interests in each of NCMRR's program areas including the behavioral, social, and biological sciences; engineering and biomaterials; and the development and evaluation of clinical practices. Both basic science and patient-oriented research training and career development is supported. Clinical Practices Program Rehabilitation encompasses a wide array of techniques and therapies used in clinical practice, including many non-pharmaceutical, non-surgical practices such as exercise, splinting and bracing, physical modalities, cognitive and memory training, and functional activity retraining. Additional research is needed for many rehabilitation techniques and therapies that have only implicit theoretical bases and that have not been rigorously evaluated in clinical trials. Research areas include, but are not limited to: o Single- and multi-center clinical trials of existing rehabilitation therapies; o Examinations of the theoretical basis of current rehabilitation clinical practices; o Clinical investigations and clinical trials of innovative rehabilitation treatments, including novel physical therapies, cognitive remediation techniques, and rehabilitation engineering products; and o Clinical trials of rehabilitation-related interventions that promote health maintenance and the prevention of secondary conditions in people with physical disabilities. Reference Brandt, EN, Pope, AM, Eds. Enabling America: Assessing the Role of Rehabilitation Science and Engineering. Washington, DC: National Academy Press, 1997. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994., available on the web at: http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at: <http://www.nih.gov/grants/guide/notice-files/not98-024.html>. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda MD 20892-7910, telephone 301-710-0267, Email Grantsinfo@od.nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact NICHD program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the NICHD staff that NICHD will accept the application for consideration for award. Finally the applicant must identify, in a cover letter sent with the application, the NICHD staff member who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://www.nih.gov/grants/guide/notice-files/not98-030.html. The title and number of this program announcement must be typed on line 2 of the face page of the application and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies in one package to the following address: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Several institutes (e.g., National Institute of Nursing Research, National Institute of Deafness and Communication Disorders) have interests that relate to rehabilitation research in specific disease areas. For example, research grant applications involving visual impairment, blindness, and their rehabilitation will be assigned to the National Eye Institute. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. The scientific review group will also examine the provisions for the protection of human subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other scored applications. The following will be considered in making funding decisions: 1) scientific and technical merit of the proposed project as determined by peer review, 2) availability of funds, and 3) program balance among research areas. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Louis A. Quatrano, Ph.D. Behavioral Sciences and Rehabilitation Engineering Program National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03 Rockville, MD 20852 Telephone: (301) 402-2242 Email: lq2n@nih.gov Mary Ellen Cheung, Ph.D. Biological Sciences and Career Development National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03 Rockville, MD 20852 Telephone: (301) 402-2242 Email: mm108w@nih.gov Stephen A. Tuel, M.S.E, M.D. Clinical Practices Program National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03 Rockville, MD 20852 Telephone: (301) 402-2242 Email: st100v@nih.gov Direct inquiries regarding fiscal and administrative matters to: Ms. Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17G Rockville, MD 20852 Telephone: (301) 496-1304 Email: mc113b@nih.gov In addition to this program announcement, NCMRR supports several funding mechanisms, including SBIR and STTR grants, program projects, career development awards and fellowships. Information on other funding mechanisms is available at: http://silk.nih.gov/silk/NCMRR/ AUTHORITY AND REGULATION 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. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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