MEDICAL REHABILITATION RESEARCH NETWORKS Release Date: April 15, 1999 RFA: HD-99-006 P.T. National Institute of Child Health and Human Development Pre-Application Conference: July 15, 1999 Letter of Intent Receipt Date: November 15, 1999 Application Receipt Date: January 12, 2000 PURPOSE The mission of the National Center for Medical Rehabilitation Research (NCMRR) within the National Institute of Child Health and Human Development (NICHD) is to enhance the quality of life for people with disabilities through research. 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. Basic and clinical studies on issues ranging from pathophysiology through impairment, functional limitation, disability and societal impact of disability are relevant to the mission of NCMRR. Multidisciplinary research programs with shared resources are an important approach to this mission, and are essential for growth and expansion of the field. Creation of a resource-related network will enhance the capabilities of investigators to open new avenues for medical rehabilitation research. The aim of this Request for Applications (RFA) is to create a broad program of research in medical rehabilitation that will serve as a focal point for collaboration and expansion of the field. The basis of this program will be four regional networks (Northeast, South, Midwest and West). The goals of the regional Medical Rehabilitation Research Networks (MRRN) are to increase research in medical rehabilitation and to attract talented investigators to the field. Sharing of unique and powerful research tools is expected to foster collaborations across departments or schools at a single institution, as well as among investigators at several institutions. The MRRN seeks to maximize the resources technologies, investigators, disciplines, and concepts--that will build a foundation for basic, applied and clinical research directed at understanding the processes of disablement, and the processes of functional recovery. 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 RFA, Medical Rehabilitation Research Networks, 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 may be submitted by domestic, 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 to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Potential applicants are strongly encouraged to contact staff listed under INQUIRIES. NICHD staff will confirm eligibility prior to the meeting of the initial review group, ineligible applications will be returned to the applicant without review. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) resource-related research project grant (R24) mechanism. This mechanism is used to support projects that enhance the capabilities of resources to contribute to extramural research of the National Institutes of Health. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. This RFA is a one-time solicitation. FUNDS AVAILABLE The estimated total funds (direct and facilities and administrative) available in FY 2000 for the first year of support for awards under this RFA will be approximately $4,000,000. It is anticipated that four awards, one representing each of the four geographical areas of the United States (Northeast, Midwest, South, and West) would be made. An applicant may request a project period of up to five years and a budget for direct costs of up to $600,000 per year, excluding indirect costs on consortium arrangements. The number of awards and level of support will depend upon receipt of a sufficient number of applications of high scientific merit. Although this RFA is provided for in the financial plan of NICHD, awards are contingent upon the availability of funds. Applicants are encouraged to discuss budget requests with program staff listed under INQUIRIES prior to submission. RESEARCH OBJECTIVES Background The NCMRR provides support for scientists to conduct research on the functional changes that result from illness, injuries, or congenital conditions, and on rehabilitation strategies that may improve whole body functioning. Research efforts must address health-related improvement in function at many levels: from pathophysiology through physical impairment, functional limitation, disability, and societal impact. A multidisciplinary approach to these goals is a fundamental part of medical rehabilitation practice, likewise, research into disability and its treatment must encompass many approaches. The regional MRRNs would encourage the collaborations and sharing of facilities and expertise that are necessary for state-of-the-art research. Such programs can promote interactions that cross disciplines and include several technical and theoretical approaches. Research in medical rehabilitation has expanded in such fields as physical medicine, physical and occupational therapy, prosthetics design, and psychology. At the same time, scientific progress has burgeoned in many areas relevant to medical rehabilitation: neuroscience, molecular biology, medical imaging, biomaterials, and genetics are but a few. It is anticipated that the MRRN will attract talented new investigators participating in these enterprises to careers in medical rehabilitation research. Likewise, established investigators from such disciplines and departments will bring concepts and techniques that can expand and energize future directions. Collaboration in medical rehabilitation research needs to be encouraged, and facilities to allow joint approaches will provide opportunities for these interactions. New, independent research can follow from these efforts. Objectives and Scope The purpose of each regional MRRN is to promote the coordination and sharing of research resources that will expand the capabilities and numbers of investigators who pursue research in medical rehabilitation. No single type or format for the MRRN will fit the needs of every region. The size, structure, operation and scientific questions pursued will be determined by factors such as resources, expertise, and experience in cooperative research efforts. Disciplines relevant for the MRRN need not be confined to those found within traditional rehabilitation departments. Examples of other relevant areas include, but are not limited to, neurology, orthopedics, pediatrics, psychology, molecular biology, radiology, or computer science. The characteristics of a network are: Each regional network will consist of a central facility, which will be the applicant institution, and a maximum of two satellite sites. Satellite sites may be either part of the administrative structure of the applicant institution, or independent entities. It is expected that the applicant institutions will support several investigators who are currently funded from federal sources (such as NIH, CDC, NIDRR) to conduct research related to medical rehabilitation. Interdepartmental collaborations are essential as part of the application. Plans for collaboration among various disciplines and use of shared facilities are required. Individual institutions may participate in only one MRRN grant, either as a central facility or as a satellite site. The regional network must include identification of a Principal Investigator at the central facility, collaborating investigators at the central facility and at any satellite sites, resources to be shared, and unique scientific projects to be conducted over the period of the award. Each network will comprise a minimum of three cores: an Administrative Core, a Research Information Technology Core, and at least one Scientific Core to be located at the applicant institution. Depending on the needs of the program, other scientific cores may be present at satellite sites within the same geographic region. Involvement of several departments and disciplines will broaden the scientific basis of medical rehabilitation research. The Administrative Core will be directed by the Principal Investigator of the MRRN and will provide the logistical focus for that network. Regular interactions among all of the investigators within the regional network are essential. Outreach activities to other fields and institutions through such mechanisms as seminars, lectures, or short courses are encouraged. The Information Technology Core will serve as a clearinghouse for ongoing research opportunities, clinical studies, research results, funding sources, and other information relevant to medical rehabilitation research within the regional network. It will promote the use of the core facilities among researchers within the parent institution and among investigators within the geographical region. National collaborations will be encouraged as part of the annual meetings of the Principal Investigators. Information on the activities and opportunities present at the MRRN should be made available to as broad a community as possible, through websites or other appropriate mechanisms. The Scientific Resource Core(s) will serve to attract researchers and foster interactive approaches to questions relevant to medical rehabilitation. At least one Scientific Core will be located at the central facility, others may be located at satellite sites. Examples of scientific cores include, but are not limited to: medical imaging (fMRI, PET, MRS, NIS, optical imaging), statistics and research design (clinical trial design, database management, patient registries), special animal facilities (primate centers, transgenic/knockout technology), bioengineering/biomechanics (gait analysis, prosthetics design, tissue engineering, biomaterials), or molecular biology (genetic screening, gene discovery, bioinformatics). The scientific cores will be utilized to facilitate collaborative research that otherwise may not occur. It is anticipated that use of the core(s) will grow throughout the period of support of the MRRN, as more investigators become aware of the opportunities. Multidisciplinary interactions will expand research in medical rehabilitation based on sharing of the resources presented in the cores. As investigators from rehabilitation departments or centers collaborate with investigators from other disciplines, new research topics and important cooperative research will emerge. It is expected that scientists who participate in the MRRN will submit independent investigator-initiated applications for research and program project grants. The Principal Investigator of the central facility will serve as the director of the network, and will coordinate the activities of the MRRN. This person is expected to devote a minimum of 20 percent effort to the network grant. S/he must serve as the director of the Administrative Core, and will establish an administrative structure that will ensure efficient utilization of the scientific facilities within the network. In addition, this individual may serve as the director of a scientific core at the central facility and/or as principal investigator for a single research project. The director is responsible for management, staffing and resource allocation, and for administering the award in accordance with NIH policies. S/he must have demonstrated ability to organize, administer, and direct collaborative research, and possess a history of achievement in research relating to medical rehabilitation. The network director will select appropriate directors for the Information Technology Core and the Scientific Core(s), and will appoint investigators to lead research efforts, including those at satellite sites. The director will ensure that sufficient professional time and staffing are devoted to the network to ensure smooth performance of proposed functions. Research Topics Collaborations are essential to approach the many disciplines relating to medical rehabilitation research. Both basic and clinical science projects are welcomed. Areas for research include, but are not limited to: o Mobility. Increasing functional mobility is a critical factor in maintaining health and independence. Studies of the body and organ systems affected by mobility disorders are relevant, as are methods to improve mobility and reduce damage. Also important are the factors in the physical and social environment that affect the mobility of persons with disability. o Behavioral Adaptation. Research depends on the coordination of information from studies of a variety of individual responses to physical and/or psychological disability, as well as to societal limitations. Additional research is needed to develop profiles that describe the course of functional loss and differential effectiveness of treatment interventions fundamental to recovery of function. o Whole Body Response. The integration of the effects of disability on whole body response to pathophysiology or impairment requires the organized input of the findings of many research disciplines. For example, researchers who study the relationships of pathophysiology to functional abilities could investigate the effects of recovery or damage on organs and organ systems beyond the lesion site. Studies of these combined effects may predict a decrease in overall function of the individual that would enhance single system studies. o Assistive Technologies. The development of assistive technologies for medical rehabilitation requires collaborations among biologists, engineers, computer scientists, clinical specialists, and persons with disability. New biomaterials that are becoming available may be particularly suited to adaptation in medical rehabilitation. o Information Transfer. Scientists need to transfer findings on the promise of research and the effectiveness of therapies to rehabilitation therapists and to people with disabilities and their families. New capabilities of information science can be used to compile relevant data more rapidly, to transform the data into meaningful messages, to present the information in an accessible manner, and to study the effectiveness of the information provided. Etiologies of interest to NCMRR have included primary physical disabilities such as amputation, spinal cord injury, stroke, traumatic brain injury, developmental disorders, multiple sclerosis, cerebral palsy, and spina bifida. Numerous secondary conditions such as spasticity, pain, psychological and behavioral effects, skin breakdown, infection, and endocrine changes that result from physical disability are also topics of research interest. SPECIAL REQUIREMENTS Annual Meeting and Advisory Committees. Prime components of the network structure are multidisciplinary collaboration and communication of research results and opportunities. To facilitate such interactions, the NCMRR will hold an annual Investigators Meeting. The network directors and one other representative from each network will attend this meeting in Rockville, Maryland. This meeting will also include members of the medical rehabilitation research community who will serve as external advisors to the networks and to NCMRR staff. The cost of participating in the annual meeting should be built into the proposed budget. Utilization of Scientific Cores. It is expected that the proposed scientific cores will be utilized throughout the funding period of the MRRN. Plans to increase utilization and promote collaboration beyond the projects described in the application are encouraged, however, prior approval from NICHD is required. Additional funding for such core use will not be routinely available. It is anticipated that the MRRN will make efforts to reach out to currently funded investigators at their institution or within their geographical region to use the core facilities and to promote medical rehabilitation research. Independent funding for projects that utilize or add to the existing cores is encouraged. 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 (59 FR 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994., available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-105.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://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed below under INQUIRIES. LETTER OF INTENT Prospective applicants are asked to submit, by November 15, 1999, a letter of intent. This letter should include: 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 fo 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: Dr. Mary Ellen Cheung National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) FAX: (301) 402-0832 Email: mm108w@nih.gov APPLICATION PROCEDURES The research grant application form PHS-398 (rev. 4/98) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research or 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. Application kits are available on the Internet at http://grants.nih.gov/grants/forms.htm All information requested in the PHS-398 application kit should be provided. In addition, specific application guidelines for this RFA are listed here. 1. Face Page. Complete all items on the application face page. This is page 1, number succeeding pages consecutively. The RFA label found in the PHS-398 (rev. 4/98) 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. On line 2, the number and title of this RFA: HD-99-006, "Medical Rehabilitation Research Networks", must be entered and the YES box must be marked. 2. Abstract of Research Plan. On page 2, describe briefly the proposed research network, indicate the core facilities that will make up the network, and the collaborative projects to be supported. List all key personnel involved in the network, use a continuation page if needed. 3. Table of Contents. Prepare a Table of Contents that includes items as listed below. The major areas to be listed in the Table of Contents appear here in capital letters. BUDGET ESTIMATES: In addition to the overall budget, include a separate budget for each core, each scientific project that will utilize the scientific core(s), and each satellite site. It is anticipated that approximately 50 percent of the total budget will be devoted to research endeavors. Note that NICHD will not provide annual support for all four networks in excess of $4 million (including facilities and administration costs) for the first year. Applicants may request up to a maximum direct cost of $600,000 (excluding overhead costs in consortium arrangements) in any single year of the award. Yearly inflation rates for years 02-05 may not exceed 3 percent. Composite budget. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD", of Form PHS-398 to present the total budget for all requested support for the first year. For each category such as "Personnel," Equipment," etc., give the amount requested for each core unit and each component project, with subtotals. For consortium arrangements involving other institutions or organizations include total (direct and facilities and administration) costs associated with such third-party participation in the "Consortium/Contractual Costs" category. Costs for purchased services should be itemized under "Other Expenses." The travel budget must include travel for the Principal Investigator and one other member of the MRRN to Rockville, Maryland to attend the annual Investigators Meeting. Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form PHS-398 to prepare a budget, by category, that provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual component research project and core unit budgets. Individual component core and research budgets. For the first year budgets of each of the cores and projects, use Form Page 4 of the PHS-398. Use Form Page 5 of the PHS-398 to report the budgets of each of the projects and cores for total project period (years 02-05). Budget justifications and explanations. Describe the specific functions of all key personnel, including consultants, collaborators, and technical staff. Purchases of large pieces of equipment are not allowed on this network grant. For years 02-05 of the application, justify any significant increases or decreases in any category over the first year budget. RESOURCES AND ENVIRONMENT. Complete the "Resources" page of PHS-398 for the overall network including both the central facility and any satellite sites. Briefly describe the features of the institutional environment(s) that are relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. RESEARCH PLAN Include a detailed Table of Contents with pagination (numeric only) at the beginning of the Research Plan. Identify each component core with a capital letter (A,B,C) that reflects the order in which the core units are presented in the application research plan. For each core, provide the name of the core director. Page limitations: The length of the sections devoted to the overall description of the program (Introductory Overview), the cores, and the scientific projects must not exceed those specified below. Investigators should endeavor to be concise. INTRODUCTORY OVERVIEW. Discuss the philosophy and objectives of the network. Include the potential impact of the proposed network on medical rehabilitation research, with an emphasis on areas of need that the network will address. An overview of the scientific expertise, unique or cross-cutting areas of research to be explored, and the influence of the proposed network on existing research programs should be included. Possible multidisciplinary collaborations within the central facility, as well as with satellite sites, should be emphasized. Evidence of institutional commitment to the network should be described. Include information showing the authority of the network director, the use of internal advisory committees (i.e., members to be selected from the applicant institution), and the method of determining core access. Describe the organizational framework and provide an organizational chart. Provide a summary table that shows quantitative use of each core by research projects. Detail the usage of the cores by the scientific projects within the application. Include any outreach efforts to promote further usage of core facilities in the future. Page limitation: 10 pages. CORE DESCRIPTIONS CORE A. ADMINISTRATIVE CORE This Core must be directed by the Network Director (PI of the grant). Include the objectives of the core, a description of its staffing, services to be provided to other cores and projects within the network, and use of internal advisory committees. Communicating the objectives of the network and providing opportunities for collaboration are encouraged. Such activities could include, but are not limited to, seminar series, lectureships, short courses, or brief visiting fellowships related to the scientific core(s) or projects. Page limitation: 10 pages CORE B. INFORMATION TECHNOLOGY CORE Communication of information on techniques, results, methodologies and research support is a vital component of the future success of medical rehabilitation research. Computer technology, print media, and telecommunications are relevant. Describe the staffing (including a Core Director and any professional or technical personnel and their duties), facilities, and resources that will be devoted to this goal. Indicate plans to make results of research or other unique features of the network available for as wide an audience as possible. Describe past or current activities relevant to such efforts. Plans to encourage use of the scientific core(s) to promote multidisciplinary research related to medical rehabilitation are an important part of this effort. Page limitation: 10 pages CORE C (D). SCIENTIFIC RESOURCE CORE(S) Provide specific titles for any proposed scientific resource cores (e.g., Functional Imaging Core, Biotechnology Core,), along with a designated Core Director who possesses expertise in this area. Depending upon the goals of individual networks, up to two scientific cores may be proposed. Describe the professional and technical staff to be involved in the core(s), and their duties. Include plans to utilize the core(s) in scientific projects, including services that will be provided and their bearing on productivity and quality of the research effort. Indicate current activity for areas to be designated as network cores, and clarify usage as part of the network. Clearly state the time that the facility will be devoted to network research, and state plans to encourage collaboration. Page limitation: 10 pages SCIENTIFIC PROJECTS. (up to three projects may be proposed) The goal of the MRRN is to create and foster new, interdisciplinary collaborations that are based on the sharing of resources, represented as scientific cores, and access to the facilities of the network. It is expected that applications for investigator-initiated research grants will result from the projects initiated at the network. In the network application, research projects may be proposed that seek to obtain pilot data or provide the basis for further research. Utilization of the scientific cores for network-related research should extend for the duration of the grant. Investigators are encouraged to include projects from new investigators, as well as from a variety of disciplines. For all proposed projects, the underlying rationale and potential impact of the studies should be specifically addressed. It must be clear that the proposed research is unique to the core facilities available within the MRRN. Projects must be described in sufficient detail to permit evaluation through the competitive peer-review process. For each scientific project undertaken as part of the MRRN, include the following sections: Abstract (one paragraph), Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods, Children as Research Subjects, Human Subjects including gender and minority considerations, Vertebrate Animals, and Literature Cited. Page limitations: 15 pages per project. 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 must be sent to: Scott Andres, Ph.D. Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and for responsiveness by the NICHD. 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 NICHD in accordance with the 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, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council. Review Criteria Criteria for the evaluation of the overall Medical Rehabilitation Research Network applications are: o Likelihood that the MRRN will enhance medical rehabilitation research based on existing capabilities and proposed collaborations. Reviewers will consider the likelihood that the proposed network will expand the scope of medical rehabilitation research, promote new research directions, facilitate interactions across disciplines and levels of analysis, and integrate theoretical or technical approaches. o Potential for the applicant MRRN to form a focus for medical rehabilitation research within the designated geographical region. Reviewers will consider the departments, institutions and/or clinical facilities that form the MRRN and the likelihood that the network will foster future independent research projects in medical rehabilitation research. Is there evidence that the institutions or departments that make up the MRRN can work together? Do the advantages of a satellite at a distant site outweigh any logistical considerations? o Intrinsic merit of the intellectual focus and research. Reviewers will examine the overall quality, scientific merit, and innovation of the activities to be supported, the likelihood that the approaches will lead to fundamental advances, and the plans and capabilities to communicate and disseminate the findings of the research and collaborative programs. o Research competence. Reviewers will consider the capability and scientific credentials of the Principal Investigator to direct the Network and maintain high standards of research collaboration, the specific technical qualifications of core directors, and the scientific accomplishments of all participating investigators. o Institutional commitment: The nature and level of resource commitment from the central facility and satellite sites. Reviewers will consider the academic and physical environment as it bears on research opportunities, space, equipment and the potential for interaction with scientists from various departments, institutions or disciplines. o Cores. Consideration of the technical merit of the core units will include: (1) Facilities within the core compared to the state-of-the-art. The contributions of the cores to fulfilling the goals of the Network. (2) The extent to which core units lend themselves to greater cooperation among Network investigators. (3) Qualifications, experience, and commitment to the Network mission of the investigators responsible for the core units and their ability to devote the required time and effort to the program. (4) Appropriateness of the budgetary requests. o Research Projects. 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 each project in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the criteria listed below will be addressed and considered in assigning the score for a research project, weighting them as appropriate for each project. Note that the project 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. In their evaluations, reviewers will comment on: (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 individual scientific projects will 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. Schedule Letter of Intent Receipt Date: November 15, 1999 Application Receipt Date: January 12, 2000 Peer Review Date: April 2000 Council Review: June 2000 Earliest Anticipated Start Date: July 1, 2000 AWARD CRITERIA Applications will compete for available funds with all other scored applications that are submitted in response to this RFA. 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. Because the goal of the RFA is to create regional networks in rehabilitation research throughout the United States, geographical distribution will be considered in making final funding decisions. INQUIRIES Researchers considering an application in response to this RFA are strongly encouraged to discuss the projects, cores, and network concept with NCMRR staff in advance of formal submission. Mary Ellen Cheung, Ph.D. Biological Sciences and Career Development National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20852-7510 Telephone: (301) 402-2242 Email: mm108w@nih.gov Louis A. Quatrano, Ph.D. Behavioral Sciences and Rehabilitation Engineering Program National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 Email: lq2n@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, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 Email: st100v@nih.gov Further information about this RFA, including a list of Frequently Asked Questions, can be found at the NCMRR homepage http://silk.nih.gov/silk/NCMRR/ For fiscal and administrative inquires regarding the announcement, potential applicants may write or call: Ms. Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17G, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1304 Email: mc113b@nih.gov 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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