MULTIDISCIPLINARY BIOBEHAVIORAL RHEUMATIC DISEASES WORKSHOPS RELEASE DATE: May 30, 2002 RFA: RFA-AR-02-011 PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute of Arthritis and Musculoskeletal and Skin Diseases LETTER OF INTENT RECEIPT DATE: October 16, 2002 APPLICATION RECEIPT DATE: November 14, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to become Principal Investigators o Special Requirements o Where to send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA Biopsychosocial perspectives and approaches to research can contribute to our understanding of etiology, course, and outcomes of rheumatic diseases. To increase integration of such approaches into rheumatic diseases research, the NIAMS has identified a fundamental need to foster interdisciplinary communication and collaboration among behavioral scientists, physicians, and basic scientists with interests in or relevant to these diseases. To this end, the NIAMS is soliciting applications to organize a workshop that will gather behavioral scientists, clinicians, and basic scientists with shared or overlapping interests to discuss the state of science in the proposed focus area and to suggest a research agenda. This workshop should be designed to enhance interdisciplinary communication, promote new collaborations, and attract investigators who are new to research in the rheumatic diseases. In addition, the meetings will define scientific needs and opportunities that may guide development of future research initiatives. RESEARCH OBJECTIVES Background In the biopsychosocial model, health and illness are conceptualized as products of a variety of factors including biological variables (e.g., genetic predisposition, exposure to pathogens), psychological factors (e.g., behaviors, beliefs, attitudes, emotions), and social conditions (e.g., social support, cultural influences). Perturbations occurring at any level in the hierarchical biopsychosocial system, from the molecular to the societal, exert effects on other levels. Thus, understanding the etiology, pathogenesis, and outcomes of disease and developing effective strategies for prevention and treatment require investigation not only in multiple separate domains and at multiple separate levels of analysis, but necessitate collaborative research efforts that integrate approaches and perspectives from multiple disciplines. This need is particularly strong in chronic diseases, whose etiology and course are often poorly understood, and which can cause life-long pain, disability, and distress. Biomedical approaches to research in the rheumatic diseases continue to yield important discoveries regarding genetic, immunologic, and other biological factors in these diseases. Behavioral and social science research is contributing important epidemiologic information and approaches to managing the distressing symptoms of these disorders. However, research integrating behavioral, basic biomedical, and clinical rheumatology perspectives has been extremely limited. The potential of the behavioral and social sciences and a biopsychosocial approach to contribute to research in the rheumatic diseases has not been fully realized. Among the obstacles delaying the development of biopsychosocial research in rheumatic diseases are professional cultures and demands that limit interaction among basic biomedical, behavioral, and clinical scientists. In the long-term interest of promoting a biopsychosocial research agenda in rheumatic diseases, the NIAMS wishes to facilitate interdisciplinary collaboration among scientists with interests in or relevant to these diseases by supporting interdisciplinary workshops. These meetings should be designed to promote enhanced interdisciplinary communication, new collaborations, and to identify biopsychosocial research needs and opportunities in the rheumatic diseases. Examples of workshops that could support the overall goals of this RFA include, but are not limited to: o Psychoneuroimmunology, CNS-endocrine-immune interactions in rheumatic diseases o Cognition and cognitive dysfunction in rheumatic diseases, brain imaging, relationships among cognition, mood disturbance, and disease activity o Biopsychosocial approaches to understanding sex, ethnic, and/or socioeconomic differences in clinical disease, symptom perception and management, interactions with the health care system o Stress – theoretical models, potential influence on disease course and presentation (e.g., symptom flares), influence of stress management techniques and interventions on illness, potential mechanisms of stress-illness effects o The problem of fatigue in rheumatic diseases – epidemiological issues, potential mechanisms, approaches to prevention and treatment o Disturbances of sleep and their relationship to disease process, symptoms, and disability in rheumatic diseases o Issues in pediatric rheumatology, including pain, psychosocial adjustment, physical functioning, and intervention approaches o Animal models – appropriate and useful animal models for elucidating biobehavioral mechanisms in rheumatic diseases, experimental approaches o Biopsychosocial approaches to understanding chronic pain and pain management in rheumatic diseases, tailoring research and intervention techniques based on individual characteristics MECHANISM OF SUPPORT This RFA will use the NIH conference cooperative agreement award mechanism (U13). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is June, 2003. This RFA uses just-in-time concepts. The NIH U13 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." Applications may request support for one conference. The total project period may not exceed 2 years, total cost of award will not exceed $50,000 (investigators who wish to propose a workshop requiring a larger budget should plan on obtaining the additional funding from other sources). 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. The anticipated award date is July, 2003. FUNDS AVAILABLE The NIAMS intends to commit approximately $100,000 in FY 2003 to fund 2 new grants in response to this RFA. Although the financial plans of the NIAMS 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. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic o Faith-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Cooperative Agreement Terms and Conditions of Award The Principal Investigator will have the primary authority and responsibility to define objectives and approaches, plan, publicize, and conduct the scientific meeting, and publish the results of the meeting. The Principal Investigator will retain custody of, and have primary rights to, information developed under the cooperative agreement, subject to Government rights of access, consistent with current Department of Health and Human Services (DHHS), PHS, and NIH policies. The NIAMS staff member named in the Notice of Award will provide significant input in the planning and conduct of the scientific meeting. This work may include working with the Principal Investigator in finalizing the meeting format and agenda, selecting topics for discussion, publicizing the meeting, selecting speakers and other meeting participants, and publishing the meeting proceedings. Publication and copyright agreements and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH document, "Guidelines for Support of Scientific Meetings by NIH," NIH Guide, October 30, 1998. An independent, third-party individual acceptable to both the Principal Investigator and NIAMS will be asked to serve as an arbitrator of any serious differences of opinion on scientific and programmatic issues that may arise during the planning and conduct of the scientific meeting. This special arbitration process will in no way affect the rights of the recipient to appeal an adverse action in accordance with PHS regulations of 42 CFR Part 50, Subpart D, and DHHS regulations of 45 CFR Part 16. These special Terms and Conditions are in addition to, not in lieu of, otherwise applicable Office of Management and Budget administrative guidelines, DHHS grant administrative regulations at 45 CFR Parts 74 and 92, as appropriate, and other DHHS, PHS, and NIH grants administration policies. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Deborah N. Ader, Ph.D. Behavioral and Prevention Research Program National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Dr., Bldg. 45, Rm. 5A19H Bethesda, MD 20892-6500 Telephone: (301) 594-5032 FAX: (301) 480-4543 (fax) Email: aderd@mail.nih.gov o Direct your questions about peer review issues to: Dr. Tommy Broadwater Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Bldg. 45, Rm. 5A25U Bethesda, MD 20892-6500 Telephone: (301) 594-4952 FAX: (301) 480-4543 Email: broadwat@ep.niams.nih.gov o Direct your questions about financial or grants management matters to: Melinda Nelson Grants Management Officer National Institute of Arthritis and Musculoskeletal and Skin Diseases Building 45, Room 5AS49F 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3535 FAX: (301) 480-5450 Email: melinda_nelson@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Deborah N. Ader, Ph.D. Director, Behavioral and Prevention Research Program NIAMS 45 Center Dr., Bldg. 45, Rm. 5A19H Bethesda, MD 20892-6500 Telephone: (301) 594-5032 FAX: (301) 480-4543 (fax) Email: aderd@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: When preparing a U13 application, the applicant must consult the "Guidelines for Support of Scientific Meetings by NIH," (https://grants.nih.gov/grants/guide/notice-files/not98-151.html). Applicants should also review the NIH policy announcement concerning the inclusion of women, minorities, and persons with disabilities in NIH sponsored and supported scientific meetings and conferences: https://grants.nih.gov/grants/guide/notice-files/not95-123.html In the Research Plan section of the application describe the anticipated role(s) of NIAMS Program staff in the proposed meetings. Following the Research Plan, the applicant should provide a statement acknowledging and agreeing to NIAMS Program staff post-award involvement in planning and conducting the scientific meeting, and should describe plans to accommodate this involvement. In the Research Plan section of the application, describe the relevance of the proposed workshop to NIAMS program goals. Description of these goals for the Rheumatic Diseases Branch and the Behavioral and Prevention Research Program can be found on the web at: http://www.niams.nih.gov/rtac/funding/grants/ep3.htm This section should also be used to provide a detailed description of the planning process, including a core planning committee, and identify the individual who will chair the proposed meetings. The timeline, topic, objectives, approximate size, and format of the workshop should be described, including the disciplines to be represented, potential participants for the meeting and how the workshop will be advertised or publicized. Plans to include trainees, early career attendees, women, and minorities should be noted. This section also should specify how meeting proceedings will be developed. IMPORTANT NOTE: The application must be submitted at least 12 months in advance of the conference, to provide enough time for peer review and program evaluation. No conference grant award will be made after the beginning date of the conference. The PHS 398 research grant application instructions and forms (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Beginning January 10, 2002, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 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 and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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: Dr. Tommy Broadwater Chief, Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive, Natcher Bldg. Rm. 5A25U Bethesda, MD 20892-6500 APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. 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 the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAMS. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAMS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the NIAMS National Advisory 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 the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o the need and timeliness for the scientific meeting, o its format and agenda, o qualifications of the organizers and proposed participants, o past performance where applicable, o appropriateness of the meeting site, o plans for the appropriate involvement of women, racial/ethnic minorities and persons with disabilities in the planning and implementation of the proposed meeting Additional review criteria for this RFA include: o The workshop"s likelihood of promoting post-workshop interdisciplinary collaboration in rheumatic diseases research and advancing a biopsychosocial research agenda in rheumatic diseases o The timeliness and need for the scientific workshop o The qualifications of the PI, organizers, and proposed participants o The appropriateness of the proposed format for achieving the stated goals o Plans for the inclusion of women, minorities, and persons with disabilities in the planning and implementation of the proposed workshops o The adequacy of the applicant"s plans to seek out and encourage the participation of junior investigators and postdoctoral fellows (if not within the scope of a particular workshop, explain why). o The adequacy of the resources and environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all of the following categories to be judged likely to have major scientific impact and thus deserve a high priority score. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 16, 2002 Application Receipt Date: November 16, 2002 Peer Review Date: April, 2003 Council Review: May, 2003 Earliest Anticipated Start Date: June, 2003 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. REQUIRED FEDERAL CITATIONS 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.846. and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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. 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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