Full Text DA-95-005 HEALTH SERVICES RESEARCH CENTERS NIH GUIDE, Volume 24, Number 5, February 10, 1995 RFA: DA-95-005 P.T. 04 Keywords: Drugs/Drug Abuse Health Services Delivery National Institute on Drug Abuse Letter of Intent Receipt Date: April 3, 1995 Application Receipt Date: May 9, 1995 PURPOSE The purpose of this Request for Applications (RFA) is to support a program of Health Services Research Centers to conduct interdisciplinary research on the financing, organization, access, and utilization of health services for drug abusers. The program is designed to complement the research grant programs of the National Institute on Drug Abuse (NIDA) by providing long-term support for interdisciplinary health services research. Each funded Center will have a coherent focus on a set of issues of current importance, and will provide scientific leadership to influence the field and stimulate additional health services research both regionally and nationally. 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, Health Services Research Centers, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for this mechanism of support. MECHANISM OF SUPPORT This RFA will use National Institutes of Health (NIH) research center grants (P50). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Support will be provided for a period of up to five years (renewable for subsequent periods) subject to continued availability of funds and progress achieved. Because the nature and scope of the research proposed in response to this RFA may vary, the size of awards may also vary. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will be accepted and will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE It is anticipated that approximately $2.0 million will be available to support the first year of the Health Services Research Center program. It is expected that approximately two Centers will be funded in FY 1995. The NIDA intends to fund at least one center that will have a primary focus on drug abuse health services financing and/or organization and management of care. If required in support of research objectives, funds may be expended on drug abuse service costs, rental and operation of facilities, approved renovation and modification of facilities (subject to limits and conditions specified in Public Health Service grant policy), and other costs normally allowable under existing PHS grants policy. Funds may not be used for new construction or to replace existing service funding. RESEARCH OBJECTIVES Background Health services research is defined by its focus on the impact of the organization, financing, and management of health services on the quality, cost, access to, and outcomes of care. The NIDA's health services research program is interdisciplinary and focuses on how services are organized, managed, financed, delivered, and utilized in established service delivery settings and at system-wide levels, as well as on the effectiveness of these services. The Health Services Research Centers program is intended to attract investigators in the behavioral, social, and economic sciences to conduct research on drug abuse health services and delivery systems, and to provide stable environments for such persons to engage in health services research. Each Center that is supported is expected to become a significant regional and national resource that will provide leadership in developing and conducting programs of health services research. Such leadership would be based primarily on the development and promulgation of a coherent and timely body of research that influences and advances the field of drug abuse services research nationwide. It will also result from various shareable resources provided by or available through the center and from a diversity of research training and information dissemination activities. Leadership is especially needed with respect to expanding the body of research on the impact of the organization, financing, and management of care on outcomes for drug abusers. The NIDA will therefore give higher programmatic priority to applications that address gaps in knowledge in these areas. In addition, wherever possible, applications should consider how the organization, management, and delivery of drug abuse services can reduce the spread of HIV/AIDS, by clarifying issues of access, utilization, and effectiveness of such services and other AIDS prevention measures. Studies of services that target high-risk populations (such as drug abusers who exchange sex for drugs or money) are also encouraged. Health Services Research Center Plan and Research Focus The application must describe the Center's Proposed Research Program in a detailed five-year plan, organized around a central drug abuse services research theme. The relationship of individual projects to the Core program must be clearly delineated. A Health Services Research Center must be an identifiable organizational unit, and it must have an administrative structure and clear lines of authority, as described under "Organization and Administration," below. Health Services Research Centers are expected to develop advances in knowledge and cross-fertilization of research beyond that which could be achieved in a cluster of individual research projects. The multidisciplinary or multifaceted character of the program, (i.e., its coordination, cohesiveness, interrelationship of the components and relationship to the central theme, and synergistic potential among the individual projects and core) are important aspects of Centers. Thus, it is essential that the Center plan and organizational structure include provision for leadership, monitoring, and coordination of research, internal quality control, communication with the research (and, where appropriate, provider) communities, ongoing assessment of research issues and needs, and sustaining high levels of research productivity and quality publication of results. In addition, attention should be given to training and development of researchers. Although research training costs are not an allowable item in Center budgets, provision for training and plans to actively seek separate funding for training will strengthen an application. In addition to supporting projects described in the application, the Center should be designed to stimulate and develop new lines of research, and take advantage of emerging opportunities to address important research issues. The Core might, for example, include a data management unit to analyze existing data (that is, data not necessarily collected by the Center) and a component to review and support small pilot projects. The Core budget may include a maximum of $50,000 per year for direct costs to support such efforts. Each Center program plan must include specific information on proposed research projects, identification of scientists to be affiliated with the proposed Center, and their roles in the program of research. Existing research programs and projects essential to the plan should be identified, and arrangements for integrating these into the Center's activities should be detailed. For data that are to be used by the Center but that are not in the public domain, letters of cooperation should be included from investigators in control of the data. For proposed multisite investigations, letters of cooperation should be included from identified programs. Health services research issues are diverse and often overlapping, and applications may focus on research within or across the areas noted below. These areas are illustrative only, and research areas not mentioned below are not necessarily excluded from consideration under this RFA. Each application should, however, emphasize how the Center would focus on selected themes and sets of issues that connect in a coherent whole, and how the Center would provide regional and national leadership in stimulating and supporting the conduct of further such research in other research settings. Financing and economic research. Research is needed on how public and private reimbursement and financing policies and practices influence the structure, operation, and effectiveness of health services for drug abusers. Research might focus, for example, on specific strategies for managing the cost and utilization of services, such as managed care systems, health maintenance organizations, and Medicaid waivers for managed care provided under fixed budgets. Research is needed to develop and test different cost models of drug abuse health services, including modeling total cost of health services, patient costs, cost effectiveness, cost and economic benefits, and social and health cost offset models. A number of States have instituted health care reform initiatives, which include cost and utilization controls, emphasis on preventive care, and other features that are of interest to health service research and public health audiences. Studies of the implementation and impact of health care financing, organization, and management of care in those States are needed, either with a focus on a single State or system of care, or in a comparative framework. Organization and management. Organizational structure and environment, management, service configuration, staffing patterns, and patterns of clinical training and expertise can influence outcomes for drug abusers. Research is needed on effective service provider management practices; effective strategies and procedures for managing the impact of HIV/AIDS, tuberculosis, and other co-occurring medical and psychological problems; and on managed service systems such as health maintenance organizations. Research is needed on the coordination and integration of drug abuse, medical, and other health and social services; the effectiveness and efficiency of various organizational and manpower configurations; counselor selection and training; the use of external resources; and systematic evaluation of patient progress and provider performance. Focus on provision, organization, and management of HIV/AIDS related services such as testing and counseling, and services to groups at high risk for HIV/AIDS is also encouraged. Health services integration models. Many service delivery approaches treat the acute symptoms of drug addiction and are unable to maximize the cumulative impact of treatment and other health services. Health service models are needed based on integration of drug abuse treatment and primary medical care, continuity of care, service utilization management, stages of recovery and change, or other approaches that emphasize the long-term, relapsing nature of drug abuse and dependence. Models should be developed and tested in relation to access and utilization, matching services to patient needs, financing and cost constraints, and cost effectiveness and cost-benefits. Research is needed to develop and evaluate integrated health service models that take into account not only patient characteristics and behavior, but also internal and external delivery system factors. Internal factors might include staffing issues, patient assessment, treatment planning, and monitoring of care; external factors include community relations, labor markets, law enforcement and criminal justice influence, and linkages to other providers. Special attention should be devoted to the relationship of these factors to the availability, quality, utilization, cost, and effectiveness of services. Need, demand, availability, access, and utilization. Health service providers and planners need to estimate need and demand for health services for drug abusers. The concept of need for treatment is complex and does not translate directly into demand for or utilization of services. Research is needed to establish the relationship between need, demand, and utilization of treatment and other health services in the general drug abusing population and in defined sub-groups. Entry, retention, and outcomes may be influenced by the accessibility of available services. For example, subpopulations eligible for Medicaid coverage may fail to obtain care because of primary provider referral requirements. Research is needed to improve accessibility of services and to reduce barriers to services for populations with defined needs. Research is needed to improve service utilization, including recruitment of target populations, monitoring utilization to modify intensity or type of service provided, efficient sequencing of services, and eliminating unneeded or inappropriate services. Applications that focus on AIDS-relevant health services research questions are encouraged. Centers are expected to develop knowledge on health services availability and utilization. A Center might, for example, gather information on: the incidence and prevalence of drug abuse problems in a region; short-term and long-term costs; demands on existing service systems for drug abusers; incentives and disincentives for providers to deliver and for clients to utilize services; and the short-term and long-term costs and benefits of existing and improved health services for drug abusers. Centers are encouraged to conduct research in conjunction with government authorities or private entities wherever appropriate. Facilities and Environment The proposed Center application must demonstrate that there are available adequate research and office facilities to carry out the objectives of the proposed Center program. It is desirable that sufficient contiguous space be committed to give the Center a high degree of cohesion and visibility. In addition, adequate reference facilities that will afford access to the relevant drug abuse and health services literature must be readily available. It is expected that such reference facilities will be the primary repository of additional reference materials that may be obtained through the Center. Relevant support services and adequate data processing facilities must also be readily accessible within or through the institution. Reasonable assurances of such support must be included with the application. Organization and Administration An individual must be designated to serve both as Principal Investigator for the Center grant and Director of the Center (PI/CD). This person should have outstanding scientific credentials and be capable of providing the leadership essential to the success of the research program. The PI/CD will have overall scientific responsibility, responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of administration and operation of the Center. The PI/CD will be responsible and accountable to the grantee institution for the proper conduct of the Center program. The grantee institution is, in turn, responsible to PHS for the performance and financial aspects of the grant supported activity. The PI/CD will be responsible for assuring interaction and collaboration among scientists conducting research within the Center, in order to promote a concerted approach to the research theme of the Center. The PI/CD will be invited to participate in NIDA's periodic research coordination meetings. The PI/CD also will be responsible for the direct monitoring of ongoing research and for identifying (with the assistance of his or her colleagues) research activities to be expanded or decreased and needs for additional resources or reallocation of resources. The applicant may also designate a Center Coordinator, who will be responsible to the Center Director and provide assistance to the Director in budget preparation, oversight of financial aspects, and administrative duties essential to the smooth operation of the Center. A letter from the applicant institution for commitment of space, staffing, and other resources essential to the Center is required as part of the application. A Center must be an identifiable organizational unit, and it must have an administrative structure and lines of authority that will facilitate coordination among Center personnel and assure maximum accountability and efficiency in Center operations. It is expected that the nature of investigators' affiliations with the Center will reflect the applicant institution's policies on appointments. An external Program Advisory Committee must be established and chaired by the Center Director. Its membership, selected by the Center Director from individuals outside the Center, can assume responsibility for review of the Center's program and for making recommendations to the Center Director on the conduct of Center activities. In addition, an internal planning committee consisting of the Center Director, Principal Investigators of each individual Center project, and others designated by the Center Director, is required. The PI is encouraged to make provisions to carry out pilot studies or innovative developmental research in promising areas of health services research. If such work is planned, the processes for identifying its scientific merit and significance to health services research and for distributing funds to pilot or developmental work should be described. If the applicant plans to sponsor meetings to identify health services research opportunities, the rationale, approach, and cost of such meetings should be included. SPECIAL REQUIREMENTS This program of research emphasizes timely transfer of results, and PIs must be willing to participate in research coordination activities to maximize the utility of the research, including review and dissemination activities. Centers should budget for costs of travel twice yearly to attend coordination meetings in the Washington, D.C. area. Center Directors are expected to coordinate with other drug abuse treatment and health services researchers to develop comparable data collection and measurement procedures where possible in order to maximize the utility of knowledge that will inform fundamental government decisions regarding health services for drug abusers. The proposed Center should have clear capability to gain the cooperation of existing drug abuse health service providers and a plausible strategy for gaining access to drug abusing populations where needed. INCLUSION OF MINORITIES AND WOMEN 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 rational and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 3, 1995, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, Maryland 20857 Telephone: 301-443-2755 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Office of Grant Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from the program administrator listed under INQUIRIES. The RFA label in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a on the face page of the application form and the "YES" box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 Bethesda, MD 20892 Bethesda, MD 20817 (express mail) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Applications must be received by May 9, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to the RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NIDA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIDA staff will return the application to the applicant. 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 NIDA in accordance with the review criteria stated below. Following peer review, site visits may be conducted prior to award to obtain additional information. Review Criteria The review criteria are: 1. Program as an Integrated Effort o The significance of the overall program goals, and the development of a well-defined central research focus of importance and relevance to the goals and mission of NIDA. o Provision for interdisciplinary coordination and collaboration, and the multidisciplinary or multifaceted character of the program (i.e., its coordination, cohesiveness, interrelationship of the components and relationship to the central theme, and synergistic potential among the individual projects and core). o Feasibility and reasonableness of plans and mechanisms proposed for the center to promote communications between different sites and/or collaborating institutions. o Role of the center director and senior investigators in providing leadership and direction in pursuing interprogrammatic opportunities for interdisciplinary research. o Composition and expertise of external advisory committee membership in relation to the research and needs of the center. o Feasibility and suitability of planned mechanisms for internal advisory and coordination functions. o The justification for, and usefulness of the core facilities to the research projects. o The scientific stature of the Investigators and the extent to which each contributes to the overall program goals as well as their commitment to the program. o Capability to provide training opportunities. o Potential of the proposed Center to become a regional and national resource as appropriate to research objectives of this RFA. o Administrative arrangements and organizational structure, through the administrative core, to facilitate and monitor the attainment of objectives and internal quality control. For example, these factors will include plans to enhance communication and cooperation among the investigators involved in the program and mechanisms for the allocation of funds for day-to-day management, long-term planning and periodic evaluation, contractual agreements, and procedures for the replacement of key personnel, e.g., the Principal Investigators, if required on an interim or permanent basis. o Reasonableness of the overall budget for the proposed work. o Specification of the process whereby pilot and developmental projects of high scientific and technical merit and high practical or theoretical significance to health services research are funded through the center. o If meetings are planned to identify health services research opportunities, specification of rationale, approach(es), and costs for these meetings. 2. Individual Projects and Core Units o Scientific and technical merit of each individual research project, and potential scientific and theoretical significance of each project. o Scientific and technical merit of core unit activities. o Feasibility of the proposed health services research projects. o Adequacy of the research design and analytic methodology proposed to conduct individual health services research projects and to carry out proposed pilot research. o The qualifications, experience, and commitment of the investigators responsible for the research projects or core units, including their ability to devote adequate time and effort to the project. o Utility of the proposed health services research to applied clinical and health service delivery practices; extent to which results are likely to improve the treatment of drug dependence and ancillary problems. o Provision for health services research training opportunities in the center, and clear intent to either provide funding from applicant's own resources or seek funding from other identified sources, such as NIDA Research Fellowships (F31 or F32 awards) or Institutional Research Training Grants (T32 awards). o The appropriateness of the budget for each of the proposed projects and core units. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 3. Resources and Environment o The academic climate and physical environment in which the research will be conducted, including the availability of space, equipment, research subjects, etc., and the potential for interaction with scientists from other departments and/or institutions. o Adequacy of the clinical and research facilities to perform the proposed research including access to subjects, instrumentation, and data management systems when needed. o Institutional commitment to health services research, its support for the proposed Center, and its ability to attract highly-qualified scientists. The initial review group will also examine the provisions for the protection of human subjects. AWARD CRITERIA Applications recommended for further consideration by the National Advisory Drug Abuse Council will be considered for funding on the basis of overall scientific, clinical and technical merit of the application as determined by peer review, appropriateness of budget estimates, program needs and balance (e.g., need for studies of financing, organization, and management of care), policy considerations, adequacy of provisions for the protection of human subjects, and availability of funds. Because of programmatic significance of HIV/AIDS risk among drug abusers, AIDS relevance of center themes and components will be a criterion in funding decisions. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Frank M. Tims, Ph.D. Services Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 Email: FTIMS@AOADA.SSW.DHHS.GOV Direct inquiries regarding fiscal matters to: Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: GFLEMING@AOADA.SSW.DHHS.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. 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 recipients to provide a smoke-free workplace and promote the non- use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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