INNOVATIVE REHABILITATION INTERVENTIONS Release Date: June 27, 2000 RFA: HD-00-016 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute on Aging (http://www.nih.gov/nia) National Institute on Deafness and Other Communication Disorders (http://www.nidcd.nih.gov/) Letter of Intent Receipt Date: August 15, 2000 Application Receipt Date: October 12, 2000 Peer Review Date: February/March 2001 Council Review: June 2001 Earliest Anticipated Start Date: July 1, 2001 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Center for Medical Rehabilitation Research (NCMRR) of the National Institute of Child Health and Human Development (NICHD), the National Institute on Deafness and Other Communication Disorders (NIDCD), and the National Institute on Aging (NIA) seek to apply advances in bioengineering, cognitive science and neuroscience to the clinical environment by encouraging the development of new techniques and therapies for rehabilitation treatments. The purpose of the Innovative Rehabilitation Interventions grant is to provide support for the initial development and testing of non-pharmaceutical and non-surgical rehabilitation interventions, including development of an effective research group, preliminary proof-of- concept projects, development of new therapeutic modalities, fabrication of new devices, and pilot studies to determine safety and effect size in preparation for future formal clinical trials. Detailed information regarding the rationale of the new technique or therapy, based on preclinical science and preliminary clinical research, must be included in the application for the Innovative Rehabilitation Intervention grant. Involvement of representatives from the targeted patient population in planning and evaluating the intervention is highly recommended. 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. Foreign institutions are not eligible for these grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Innovative Rehabilitation Interventions support is for new projects and may not be used to supplement research projects already being supported or to provide interim support of projects under review. Simultaneous submissions of applications for both an innovative grant and a regular research project grant (R01) on the same topic will not be accepted. Only one Innovative Rehabilitation Intervention grant application from an individual Principal Investigator will be considered. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory/Developmental Grant (R21) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. For this RFA, funds must be requested in $25,000 direct cost modules, up to a total direct cost of $150,000 per year. FUNDS AVAILABLE The NICHD intends to commit approximately $900,000, the NIA intends to commit approximately $300,000, and the NIDCD intends to commit approximately $500,000.00 in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2001 to fund six to eight new grants in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs of up to $150,000 per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards also will vary. Although the financial plans of NICHD, NIA, and NIDCD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 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 peer review procedures. RESEARCH OBJECTIVES Background Millions of people in the United States suffer disabling injuries or diseases each year. Over 50 million individuals live with chronic physical and sensory impairments and disabilities due to conditions such as cerebral palsy, metabolic disorders, burns, arthritis, AIDS, amputation, cancer, injury to the brain or spinal cord, spina bifida or muscular dystrophy. Additionally, dysfunction can result from aging/age-related changes in a variety of systems (including musculoskeletal, neuromuscular, sensory and cognitive changes) and innovative rehabilitation strategies for older persons are presently lacking. Rehabilitation of these conditions can involve a wide array of non-pharmaceutical, non-surgical techniques and therapies used in clinical practice. These practices range from muscle- and joint-related techniques such as exercise, splinting and bracing, and physical modalities (e.g., heat, cold, ultrasound, electrical stimulation, etc.), to cognition- related practices such as executive function, speech/language and memory training, to combinations, such as mobility and self-care training. Historical precedent without definitive outcome research drives many of these therapies. Unlike pharmaceuticals and medical devices, which can be patented, many rehabilitation techniques are less interesting to large corporations and need support from the public sector. With the advances in biotechnology, many new techniques and therapies are available for rehabilitation treatments and need evaluation. These include a variety of methods of electrical stimulation, computer-controlled devices to extend various rehabilitative techniques outside of the traditional hospital or clinic, miniaturized performance monitoring devices (such as load cells, video, etc.) that can monitor dosage of physical therapies, and many other innovative techniques that have not yet been reported in the literature. This RFA crosses multiple emphases in the NCMRR Research Plan including improving functional mobility, improving behavioral adaptation, improving whole body system response, and improving assistive technology. In addition, it addresses a major priority in the NIDCD strategic plan, the development and improvement of devices, pharmacologic agents, and strategies for habilitation/rehabilitation of human communication disorders. Scope The following items provide examples of subject areas that are within the scope of the RFA. The NIA would be specifically interested in any of the following areas as they relate to physical and/or cognitive dysfunction in older persons. This list is not exhaustive, and applicants are encouraged to communicate with program staff regarding the responsiveness of other topics to this RFA. 1. Interventions to improve the functional balance and mobility of persons with chronic disability, including physiotherapy, electrical stimulation, and other physical modalities. 2. Interventions to improve the cognitive, sensory, communicative, and behavioral functioning of people with disabling conditions such as traumatic brain injury or stroke, including cognitive retraining and remediation, speech/language therapy, environmental modifications, and other behavioral therapies and techniques. 3. Interventions to prevent and/or ameliorate secondary conditions with a higher prevalence among people with physical disabilities. These conditions include depression, memory loss, muscle atrophy, pressure ulcers, cardiopulmonary deconditioning, and bowel, bladder, and sexual dysfunction. 4. Interventions that utilize assistive technology to improve the daily function of persons with chronic disability, including prosthetics and orthotics, cognitive, sensory and communicative aids, and other devices. Supported Activities Innovative interventions are often trans-disciplinary, thus, the types of activities that may be supported through this RFA include: o Development of an effective research group resulting in a definitive research plan for a future regular research grant application. Activities may include: salary support for collaborative investigators, travel to multidisciplinary academic conferences or to meetings outside the researchers general area of expertise, and hosting a small trans- disciplinary meeting to explore innovative treatments. o Exploratory projects, including: basic animal and preclinical human studies on the mechanism(s) underlying the innovative intervention, identification of markers and endpoints appropriate to the intervention, identification and validation of measures, especially measures of dose/quantity of treatment, and descriptive trials in related groups of subjects. o Fabrication of new devices necessary to apply the intervention. o Pilot clinical studies designed to: identify side-effects and complications associated with the intervention, develop inclusion and exclusion criteria for future clinical trials, develop estimates of effect size and select specific methods of data analysis, and provide preliminary data for subsequent grant applications. 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating 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," published in the Federal Register of March 28, 1994 (59FR 14508- 14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the Internet at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that children (i.e., individuals under the age of 21) must be included in all human subject research, conducted or supported by the NIH, unless there are scientific and/or 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," published in the NIH Guide for Grants and Contracts, March 6, 1998, and available on the Internet at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. URLs IN NIH GRANT APPLICATIONS AND APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit 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 this RFA. 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 plan the review. The letter of intent is to be sent to Dr. Louis Quatrano, at the address listed under INQUIRIES, below, by August 15, 2000. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, on the Internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html, 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, E-mail: GrantsInfo@nih.gov. Application Instructions The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept requires the submission of certain information only when there is the possibility of an award. It is anticipated that these changes will reduce the administrative burden for applicants, reviewers, and institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $150,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed indicating Direct Costs (in $25,000 increments up to a maximum of $150,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION: Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form Page. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the proposed project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus F&A costs) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and role on the proposed project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH: The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A Biographical Sketch is required for all personnel, following the instructions below. No more than three pages may be used for each person. A sample Biographical Sketch may be viewed at http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the Form Page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o OTHER SUPPORT: Do not complete this section. It is not required and will not be accepted with the application. o CHECKLIST: This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and telephone number of the individual to contact concerning fiscal and administrative issues if additional information is required following the initial review. Submission Instructions The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application and must display the RFA number HD-00-016. A sample RFA label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note that this is in the pdf format. 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 2 of the face page 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: 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) At the time of submission, two additional copies of the application should be sent to: L.R. Stanford, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E-03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-496-9254 Applications must be received by October 12, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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 CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude 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 the CSR and for responsiveness by the NICHD, NIA, and NIDCD. Incomplete and/or non- responsive applications will be returned to the applicant without further consideration. 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, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council, the National Advisory Council on Aging, or the National Advisory Deafness and Other Communication Disorders Council. 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 their 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, weighted by the reviewers 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 methods? 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. AWARD CRITERIA Applications will be selected for funding based on their scientific and technical merit as determined by peer review, availability of funds, and program priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Investigators also may obtain copies of relevant policy documents from program staff contact. Direct inquiries regarding programmatic issues to: Louis Quatrano, Ph. D. Behavioral Sciences and Rehabilitation Engineering National Institute of Child Health and Human Development 6100 Executive Blvd., 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-402-4221 FAX: 301-496-0832 E-mail: quatranl@exchange.nih.gov Judith A. Cooper, Ph. D. Chief, Scientific Programs Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders, NIH 6120 Executive Blvd., EPS-400-C, MSC 7180 Bethesda, MD 20892-7180 Telephone: 301-496-5061 FAX: 301-402-6251 E-mail: Judith_Cooper@nih.gov Judith A. Finkelstein, Ph. D. Neuroscience and Neuropsychology of Aging National Institute on Aging Gateway Building, Suite 3C-307 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: 301-496-9350 E-mail: Finkelsj@exmur.nia.nih.gov Direct inquiries regarding fiscal matters to: Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Blvd., 8A17, MSC 7510 Telephone: 301-496-1304 FAX: 301-402-0915 E-mail: ColvinM@mail.nih.gov Sharon Hunt Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Blvd., Room 400-B, MSC 7180 Bethesda, MD 20892-7180 Telephone: 301-402-0909 FAX: 301-402-1758 E-mail: Sharon_Hunt@nih.gov Cynthia Riddick Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: 301-496-1472 FAX: 301-402-3672 E-mail: RiddickC@exmur.nia.nih.gov HEALTHY PEOPLE 2001 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2001," a PHS- led national activity for setting priority areas. This Request for Applications (RFA) is related to one or more of the priority areas. Potential applicants may obtain "Healthy People 2001" at: http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.929, Medical Rehabilitation Research, 93.866, NIA, and 93.173, NIDCD. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 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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