Full Text HD-95-010 PAIN MANAGEMENT FOR PERSONS WITH PHYSICAL DISABILITIES NIH GUIDE, Volume 23, Number 45, December 23, 1994 RFA: HD-95-010 P.T. 34 Keywords: Pain Rehabilitation/Therapy, Physical Treatment, Medical+ National Institute of Child Health and Human Development Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: May 16, 1995 PURPOSE The National Center for Medical Rehabilitation Research (NCMRR) invites applications for program projects to conduct rehabilitation research to improve the prevention and management of chronic pain experienced by persons with designated physical impairments. The chronic pain of interest is a secondary condition associated with the primary impairments of spinal cord injury, amputation, cerebral palsy, spina bifida, or traumatic brain injury. Program project applications are encouraged that take into account the pathophysiological, subjective, behavioral, cognitive, and social manifestations of chronic pain as a secondary condition. The award of at least two program projects is anticipated. 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), Pain Management for Persons with Physical Disabilities, is related to the priority areas of other 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 domestic 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) program project (P01). Applicants should be familiar with NICHD program project guidelines. A copy may be obtained from the NICHD office listed under INQUIRIES. Responsibility for the planning, direction, and execution of the proposed program will be solely that of the applicant. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (rev. April 1994). The total project period for applications submitted in response to this RFA may not exceed five years. The anticipated award date is December 1, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will vary also. This RFA is a one-time solicitation for applications for new awards. Future unsolicited continuation applications will compete with other applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Approximately $1 million direct cost for the first year will be committed to fund applications submitted in response to this RFA. It is anticipated that two applications will be funded. The number of awards is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this RFA is provided for in the financial plans of the NCMRR, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background This initiative builds directly on recommendations emanating from an NCMRR workshop on management of chronic pain that was conducted in March of 1993. A panel of experts evaluated the state of science, determined research needs and opportunities, and made recommendations for rehabilitation research in the area of chronic pain. To receive a copy of the panel report ("Chronic Pain Management: Developing A Treatment System For People with Disabilities," March 1-3, 1993, National Center For Medical Rehabilitation Research, Bethesda, Maryland (Unpublished Report)), send a mailing label and request to the program administrator listed under INQUIRIES. This RFA is focused on research to improve the prevention and management of chronic pain experienced by people with spinal cord injury, amputation, cerebral palsy, spina bifida or traumatic brain injury. This RFA encompasses the five domains of investigation that are identified in the "Research Plan for the National Center for Medical Rehabilitation Research" as being relevant to medical rehabilitation (Research Plan for the National Center for Medical Rehabilitation Research, March 1993, National Institutes of Health, Bethesda, MD, NIH Publication No. 93-3509). These are: pathophysiology, impairment, functional limitation, disability, and societal limitation. Scope The objectives of this RFA are to stimulate the establishment of program projects that are multidisciplinary research approaches to chronic pain and to bring together, on a cooperative basis, clinical and basic science investigators in a manner that will foster communication, innovation, and high quality research. To accomplish these objectives, the applicant institution or collaborating institution must be conducting an ongoing program of excellence in biomedical research related to the study of chronic pain. This research should be in the form of NIH-funded research projects (R01), FIRST Awards (R29), program projects (P01), or other peer reviewed research supported by federal or non-federal sources. Applications on behalf of more than one institutions should include documentation demonstrating the capacity of each to participate in the program and their willingness to implement common protocols targeting rehabilitation- specific research questions. The theoretical bases for proposed studies must be clearly explicated. Interventions to be tested must be clearly defined in terms of their purpose, sample composition, means of implementation and anticipated effects. Particular attention should be paid to ensuring that the anticipated effects are linked with well defined outcome measures. These might include but are not limited to: reduced medication dependency, reduced psychosocial disruption, increased functional activity, fewer reports of pain, reduced health care costs, and a return to age-appropriate activities. Applications must address one or both of the following research themes. 1. Examining the effectiveness of specific treatments (either pharmacological or non- pharmacological) that are currently used to manage different types of chronic pain in different populations of people with physical disabilities. 2. Developing and evaluating new or improved treatments (either pharmacological or non-pharmacological) to manage different types of chronic pain in different populations of people with physical disabilities. Current Treatments Subprojects to evaluate interventions (e.g., pharmacological, surgical, physiotherapeutic, or behavioral) that are used currently to manage different types of chronic pain in different populations may include, but are not limited to: o evaluating the pathophysiology of different types of pain from a basic science perspective to elucidate relationships among pathology, pain intensity, and potential treatments of pain; o developing and testing conceptual models to specify the mechanisms responsible for the prevention and management of chronic pain; and, o investigating effects of interventions on functional, psychosocial or quality-of-life issues for persons with disabilities who experience chronic pain. New or Improved Treatments Subprojects to evaluate new or improved interventions (e.g., pharmacological, surgical, physiotherapeutic, or behavioral) to prevent or manage different types of chronic pain may include, but are not limited to: o evaluating the pathophysiology of different types of pain from a basic science perspective to elucidate relationships among pathology, pain intensity, and potential treatments of pain; o developing and testing conceptual models to specify the mechanisms responsible for the prevention and management of chronic pain; and, o investigating effects of interventions on functional, psychosocial, or quality-of-life issues for persons with disabilities who experience chronic pain. 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. 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. Investigators also may obtain copies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 15, 1995, 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 a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Louis A. Quatrano, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Executive Building, Room 2A03 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used to prepare the application. These forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301-710-0267, and from the program administrator listed under INQUIRIES. Grant applications will be supported through the program project (P01) mechanism. The application should be prepared in a manner consistent with the general guidelines in the publication "NICHD P01 PROGRAM PROJECT GUIDELINES," which are available from the NICHD office listed under INQUIRIES. 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. 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. Acting Director Division of Scientific Review National Institute of Child Health and Human Development Executive Building,Room 5E01 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 Applications must be received by May 16, 1995. 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 RFA 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 for completeness by DRG and responsiveness by the NICHD. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score, and will also receive a second level of review by the NICHD Council. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator/Program Director and the official signing for the applicant organization will be notified. Peer Review Criteria The scientific and technical merit peer review of program projects focuses on two areas: (1) review of the overall program as an integrated, synergistic effort; and, (2) review of the component research projects and core units. Overall Program Criteria The criteria for reviewing the program as an integrated effort are: o the coordination, interrelationship, cohesiveness, and synergism among the individual research projects and core components; relationship of the program objectives to the common theme; the advantages of pursuing the proposed research as a program project rather than through individual research grants; o relevance of the program to the NCMRR mission; o leadership ability and scientific stature of the program director and his/her ability to meet the program's demands of time and effort; o participation of a suitable number of responsible, experienced investigators; o an appropriate organizational and administrative structure for effective attainment of program objectives; o arrangements for internal quality control of ongoing research, the allocation of funds, day-to-day management, contractual agreements, and internal communication and cooperation among program investigators; o the institutional environment in which the research will be conducted, including the availability of space, equipment and subjects; physical proximity of investigators and the potential for interaction with scientists from other areas; o the appropriateness of the program size: small enough to afford effective interaction focused on a specific central theme and large enough to achieve synergy and economies not provided by regular research grants; o institutional commitments to the program requirements. Individual Projects and Core Unit Criteria The review criteria for the component research projects and core units are: o the scientific merit of each individual project in the program context; o the specific scientific objectives of each project that will benefit significantly from or depend upon, collaborative interactions with other P01 projects (e.g., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness, and/or economy of effort); o accomplishments and progress to date of the component research projects, if appropriate; o qualifications, experience, and commitment of the investigators and their ability to devote the required time and effort to the program; o the appropriateness of the budget for each component research project and core unit; cost effectiveness and quality control of core units; o the appropriateness of the research projects use of core services; o the adequacy of the means proposed for protecting against risks to human subjects, animals, and the environment; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The review of program project applications assigned to NICHD may include a site visit or applicant interview. However, these are not review requirements and should not be depended upon to supplement an incomplete written application. If a site visit is planned, the principal investigator will be contacted by the Scientific Review Administrator. AWARD CRITERIA The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o availability of funds; o geographical location of the applicant organization; o program balance among research areas of this announcement; and, o relevance to medical rehabilitation. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquires regarding programmatic issues to: Louis A. Quatrano, PhD National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Executive Building, Room 2A03 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 Email: quatranl@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary Ellen Colvin Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 8A17G 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 Email: colvinm@hd01.nichd.nih.gov 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 Part 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 Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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