MULTIDISCIPLINARY CLINICAL RESEARCH CENTERS FOR ARTHRITIS, MUSCULOSKELETAL, AND SKIN DISEASES Release Date: March 23, 2000 RFA: AR-00-004 National Institute of Arthritis and Musculoskeletal and Skin Diseases http://www.nih.gov/niams/ Letter of Intent Receipt Date: December 1, 2000 Application Receipt Date: January 17, 2001 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for a new program of Multidisciplinary Clinical Research Centers (MCRCs) in arthritis and/or musculoskeletal disorders and/or skin diseases. The goals of this new program are to prevent disease and to assess and improve outcomes for patients with arthritis and other rheumatic diseases; musculoskeletal disorders including orthopaedics, bone diseases and muscle diseases; and skin diseases. For a comprehensive listing of the disease areas covered in the NIAMS extramural programs, please see http://www.nih.gov/niams/grants/gen2.html Each MCRC will be organized around a methodology core and will be expected to include a minimum of three highly meritorious projects encompassing clinical research drawing from different disciplines. The methodology core will be the foundation of the center, providing key support for development and implementation of clinical projects. Each project must address a critical issue that directly involves prevention, assessment and/or outcomes for patients with one or more of the many chronic diseases within the mission of the NIAMS. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Multidisciplinary Clinical Research Centers for Arthritis, and Musculoskeletal and Skin Diseases, is related to one or more of the priority areas. Potential applicants may obtain "Healthy People 2010" at http://www.health.gov/healthypeople/. 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 center grants. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. An established clinical research program in arthritis and/or musculoskeletal disorders including orthopaedics, bone diseases and muscle diseases; and/or skin diseases must be present. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) P60 award mechanism. 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 should be five years. New and competing continuing applications may be submitted only in response to an RFA. The anticipated award date is January 1, 2002. FUNDS AVAILABLE The NIAMS intends to commit approximately $3.6 million in FY 2002 to fund up to three applications responding to this RFA. The applicant should request a project period of five years. The direct costs requested cannot exceed $800,000 each year (exclusive of facilities and administrative costs of subcontracts with collaborating organizations). Although the financial plans of the NIAMS provide support for this program, awards pursuant to this RFA and future RFAs are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. This RFA is the second of three RFAs to establish the new NIAMS MCRC program. A previous RFA was issued November 25, 1999, for applications due August 25, 2000 for FY 2001 funding. A third RFA is planned for funding up to two applications in FY 2003. RESEARCH OBJECTIVES Background: NIAMS has completed a review of its Centers Program. The Institute, guided by the report from the Centers Working Group II (see http://www.nih.gov/niams/reports/cenrptfn.htm ), discussions with the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council and discussions with the research community in various formats, including a series of nationwide video conferences during the summer of 1998, determined that the Multipurpose Arthritis and Musculoskeletal Diseases Centers (MAMDCs) will be discontinued. Centers formerly funded as MAMDCs will be eligible to apply for both the new Multidisciplinary Clinical Research Centers (P60) and for Core Centers (P30s). The new P60 centers will be known generically as Multidisciplinary Clinical Research Centers (MCRCs), although each center will identify itself by one or more of the NIAMS three broad disease areas: arthritis, musculoskeletal diseases/disorders, skin diseases. Description of the new MCRC program The goals of the new Multidisciplinary Clinical Research Center (MCRC) program are to prevent disease and to assess and improve outcomes for patients with arthritis and other rheumatic diseases; musculoskeletal disorders including orthopaedics, bone diseases and muscle diseases; and skin diseases. For a comprehensive listing of the disease areas covered in the NIAMS extramural programs, please see http://www.nih.gov/niams/grants/gen2.html o Any given MCRC will not be expected to include all disease areas defined above or all clinical approaches included in the NIH definition of clinical research. An MCRC can focus on one or more disease areas, but should not focus on just one disease. Two or more clinical approaches (patient-oriented research, epidemiologic and behavioral studies, outcomes research and health services research) must be encompassed by the projects supported in the MCRC. o Each MCRC will define its research base, goals for promoting clinical research utilizing that research base, and how multidisciplinary research will be promoted. The interaction with a General Clinical Research Center (GCRC), if present, must be documented. o An MCRC is not a mechanism to support a large clinical trial, but proof of concept trials may be appropriate. In addition, research on animals and animal models should not be proposed in the MCRC application. The key elements of an MCRC will include: 1. a Center Director, Associate Director and an executive committee with outstanding credentials for promoting clinical research; 2. a research base that encompasses diseases/disorders within the NIAMS mission and provides professional and patient resources for developing clinical projects using more than one clinical research approach; 3. a methodology core that will play a key role in the design and implementation of ALL projects supported through the center; and 4. a minimum of three highly meritorious clinical research projects that encompass one or more of the disease areas (but not one disease) within the NIAMS mission and utilize the methodology core. Optional elements of an MCRC are (a) a development and feasibility project supported by the methodology core and lasting no more than three years and (b) other core(s) supportive of two or more of the proposed projects. The Director of the MCRC, aided by an Associate Director, an executive committee and the methodology core, is expected to provide leadership to focus all research projects on clinically relevant issues to improve patient outcomes and to assure a rigorous research approach. The proposed director should document this leadership with examples of the ability to network with colleagues from clinical and other areas of biomedical research. A methodology core is a required component of the MCRC and must serve all projects proposed in the center. The core should have sufficient professional personnel to provide an interactive leadership role not only in supporting the projects within the MCRC, but also promoting rigorous methodologic and biostatistical support for the research base. Other cores supporting two or more of the research projects proposed may be requested. A minimum of three highly meritorious clinical research projects, each with a focus to prevent disease or to assess and/or improve outcomes for patients, must be present in an MCRC. Each project will define the patient problem under study and the anticipated improvement in assessment and/or outcome for the patient that might be realized through this project. The projects must represent two or more general areas of clinical research. An optional component in an MCRC is a development and feasibility project lasting no more than three years. The goal of the development and feasibility project should be to gather preliminary data or to develop a resource for a future study. SPECIAL REQUIREMENTS The Director and Associate Director should budget for an annual one-day meeting in Bethesda, MD with NIAMS staff. 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 was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: https://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 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 the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR 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, by December 1, 2000, 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 subsequent applications, the information that it contains allows NIAMS staff to estimate the potential review workload and to avoid conflict of interest in the selection of reviewers. The letter of intent is to be sent to Dr. Julia B. Freeman at the address listed under INQUIRIES. 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 and may be obtained 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@nih.gov. Special guidelines have been developed by NIAMS for the MCRC program. These guidelines should be used in assembling the application. See INQUIRIES for obtaining a copy of these guidelines. 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. Type the RFA number on the label. 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, "Multidisciplinary Clinical Research Centers", and number, "AR-00-004", must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies of the application 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, send two additional copies of the application and all six copies of the appendices to: Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.25U - MSC 6500 Bethesda, MD 20892-6500 Bethesda, MD 20814 (for express/courier service) Applications must be received by January 17, 2001. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications for MCRC grants will first be screened for completeness by the Center for Scientific Review and for responsiveness by the NIAMS. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications which are complete and responsive will be further evaluated for scientific merit in accordance with the review criteria stated below by a group of expert consultants convened by the Review Branch of the NIAMS. 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 Advisory Council for NIAMS. 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. Each project and core (including the administrative unit) will be individually reviewed for scientific merit and a rating assigned by committee consensus. Merit ratings will also be voted for the center elements: qualifications of the center leadership, the research base, the institutional environment and resources. If this is an application from a group that formerly worked under a MAMDC, the progress under the Education, Epidemiology and Health Services Research component progress during the last funding cycle will also be evaluated. To be funded, there must be a highly meritorious methodology core and at least three highly meritorious projects (not including the developmental/feasibility project, if any). Review Criteria for MCRC leadership: Do the Director and Associate Director have the leadership and research qualifications to lead a Center? Does the leadership team (Director, Associate Director, and executive committee) have the collective expertise to assure focused development and implementation of high quality and meaningful clinical research projects? Review Criteria for Research Base: Is there a substantial productive and funded research base? Is the research base sufficiently broad to foster new interdisciplinary research? Is there a definition of who will be a Center investigator and what this designation might mean? Review Criteria for Institutional Base: Is there evidence of a supportive institutional environment for the proposed MCRC? Will the MCRC add an important multidisciplinary element to the institutional environment? Does the proposed MCRC utilize available resources well? Is there support and commitment from the institutional authorities? Review Criterion for applications from previous Multipurpose Arthritis and Musculoskeletal Diseases Centers (MAMDCs): Does the progress report reflect significant accomplishments that were derived from the MAMDC clinical component as reflected in new concepts and publications? Review Criteria for Administrative Unit: 1. Do the proposed MCRC Director, Associate Director and executive committee have the collective expertise and leadership to identify and focus research projects on clinically relevant issues? 2. Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.? 3. Is there a plan for establishment and maintenance of internal communication and cooperation among the MCRC investigators, core leaders and executive committee? Are there plans for outside review and input? 4. Is there scientific and administrative leadership, commitment and ability, and adequate time commitment of the MCRC Director and Associate Director for the effective management of the MCRC program? 5. Is there documentation of institutional support for the MCRC by the parent institution? Review Criteria for Methodology Core: 1. Does the methodology core serve all projects proposed in the Center (mandatory)? Have issues relating to data and safety monitoring been addressed? Is there a plan for offering teaching services to the research base? 2. Are the services offered appropriate and of high quality, especially for the projects directly supported? How is cost reimbursement proposed? 3. Will the core likely promote interdisciplinary research? Are unique services offered? Is there a plan for prioritizing services to the research base? 4. Are the qualifications of the professional and support personnel appropriate? Is there a plan for interactive leadership of the methodology core and the proposed projects? 5. Are the facilities and equipment adequate? Is there institutional commitment to the core? Review Criteria for Other Cores: 1. Will the core have utility to at least two of the MCRC projects? 2. Are the services of high quality? Are there procedures for quality control? Is the core cost effective? 3. Do the services offered best fit within a core structure? If this is an add-on to a preexisting core, what is the benefit to the Center over direct purchase of services from the existing core? If the core offers new services that may be used by non-MCRC projects, how will the non-MCRC projects purchase these services from the core? 4. Are the personnel appropriate? 5. Are the facilities and equipment adequate? Is there institutional commitment to the core? Review Criteria for Research Projects: Significance: Does this study address an important clinical issue, especially one not well studied? Is it likely that the research may have a clinically important impact? Will these studies influence concepts or methods that drive this field? Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the investigator acknowledge potential problem areas and consider alternative tactics? Does the project utilize the multidisciplinary resources of the Center, especially the Methodology Core? Innovation: Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (The quality of the idea or the extent to which the research will advance theory or practice should outweigh an emphasis on technical excellence.) 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 collaborators? Environment: Does the scientific environment of the Center contribute to the probability of success? Do the proposed experiments take advantage of unique features of the Center and employ useful collaborative arrangements? Review Criteria for Development and Feasibility Project (Optional): Significance: Does this study address an important problem? If the aims of the application are achieved, will the work be the basis for a full research proposal? Approach: Does the study utilize the expertise of the methodology core? Does the investigator acknowledge potential problem areas and consider alternative tactics? Does the project utilize the multidisciplinary resources of the MCRC? Innovation: Does the project employ sound concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (The quality of the idea or the extent to which the research will advance theory or practice should outweigh an emphasis on technical excellence.) 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 collaborators? Environment: Does the scientific environment of the Center contribute to the probability of success? Do the proposed experiments take advantage of unique features of the Center and employ useful collaborative arrangements? After the review of the individual components of the application, an application may be unscored or assigned an overall priority score. This score will reflect not only the individual quality of the projects, cores, and administration, but also how the proposed MCRC will bring together all these elements in a workable unit. The overall score may be higher or lower than the "average" of the descriptors based on the assessment of whether the "whole is greater than the sum of its parts." The overall priority score will reflect: 1. The scientific excellence of the Center's research base as well as the relevance and interrelation of these separately-funded research projects to the goals of the Center and the likelihood for meaningful collaboration among Center investigators. The application must convey how the proposed Center will enhance significantly the established research base of the host institution. 2. The overall environment for a Center. This includes the institutional commitment to the program, including lines of accountability regarding management of the Center, and the institution's partnership with the Center, and the institutional commitment to individuals responsible for conducting essential Center functions. This also includes the academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and schools. 3. The overall priority score assigned to the application will also reflect how well the policy regarding the inclusion of women, minorities and children in study populations has been addressed. Schedule Letter of Intent Receipt Date: December 1, 2000 Application Receipt Date: January 17, 2001 Peer Review Date: June-July, 2001 Council Review: September 24 - 25, 2001 Earliest Anticipate Start Date: January 1, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. Since the NIAMS is interested in funding only the most highly meritorious research, individual components of lesser quality may not be funded, even if approved, under the "umbrella" of the Center grant mechanism. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues and letters of intent may be directed to: Dr. Julia B. Freeman Centers Program, EP National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS.19F - MSC 6500 Bethesda, MD 20892-6500 Bethesda, MD 20814 (for express/courier service) Telephone: (301) 594-5052 FAX: (301) 480-4543 Email: Julia_B_Freeman@nih.gov Copies of the guidelines for the NIAMS MCRC program may be obtained from: NIAMS Clearinghouse 1 AMS Circle Bethesda, MD 20892-3675 Telephone: (301) 495-4484 FAX: (301) 587-4352 Guidelines are also available on the internet: http://www.nih.gov/niams/grants/ep7.htm Direct inquiries regarding fiscal matters to: Sally A. Nichols Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building Room 5AS.49F - MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3535 FAX: (301) 480-5450 Email: nicholss@exchange.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research. 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 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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