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NIH Guide: RESEARCH ON MENTAL HEALTH ECONOMICS

 RESEARCH ON MENTAL HEALTH ECONOMICS NIH GUIDE, Volume 22, Number 45, December 17, 1993 PA NUMBER: PA-94-018 P.T. 34 Keywords: Health Care Economics Emotional/Mental Health Health Services Delivery National Institute of Mental Health PURPOSE The purpose of this program announcement is to encourage investigator-initiated research on mental health economics in order to advance the scientific knowledge base in this field and assist in the development of improved strategies for financing and reimbursing mental health services. The research invited under this program announcement is also intended to maintain and increase the contribution of applied economic research to the development and analysis of plans for the mental health component of various local, State, and national level health care reform proposals. 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 PA, Research on Mental Health Economics, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (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 Applications may be submitted by foreign and 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 First Independent Research Support and Transition (FIRST) (R29) awards and Research Program Projects (P01). Applications from minority individuals and women are encouraged. MECHANISMS OF SUPPORT Research support may be requested through applications for a regular research grant (R01), small grant (R03), First Independent Research Support and Transition (FIRST) award (R29), Multi-Institutional Collaborative Research Project (R10), program project grant (P01), Investigator-Initiated Interactive Research Project Grant (IRPG), research demonstration (R18), and Research Infrastructure Support Program (RISP). Funds may not be used to establish or operate a treatment, rehabilitation, or other service program, except in the case of a research demonstration grant (R18). Announcements including special requirements regarding eligibility for the small grants program (R03), FIRST awards (R29), Multi-Institutional Collaborative Research Project program (R10), and Investigator-Initiated Interactive Research Project Grant (IRPG) are available from the National Institute of Mental Health, 5600 Fishers Lane, Room 9-95, Rockville, MD 20857, telephone 301/443-4673. Because the nature and scope of the research proposed in response to this announcement will vary, it is anticipated that the size of the awards will also vary. Applications may request support for up to five years for regular research and research demonstrations. Annual awards will be made, subject to continued availability of funds and progress achieved. A competing continuation (renewal) application for an R01 may be submitted near the end of an approved period of support in order to request funds for continuation of the project. Small grants are limited to two years and may not be renewed. FIRST Awards are for five years but are not renewable. RESEARCH OBJECTIVES Background Approximately 10 percent of the total national health care expenditures are spent on treating mental disorders. However, many Americans with mental illnesses find that appropriate treatment is inaccessible because they lack insurance coverage or the insurance they have for mental illness is inadequate. Recent efforts to reform the health care system have stressed the need to expand the field of mental health economics research. The National Institute of Mental Health (NIMH) has broadened its interest in supporting high-quality policy relevant research on the economics of mental health to find more efficient and equitable mechanisms of financing mental health care for people with mental disorders and to prepare for various scenarios of health care reform. Health care reform provides a unique opportunity to strengthen the field of mental health economics research. There is an urgent need to increase the number of mental health economists and the capacity of other mental health services researchers to conduct studies relevant to health care reform. It is expected that scientific findings produced by grants submitted in response to this announcement will ensure that the mental health field will continue to play an integral and compelling role in the national debate on mental health care benefit options in health care reform initiatives. Objectives Researchers are encouraged under this program announcement to develop rigorous research designs for the exploration of important research topics in mental health economics. The following areas of research are illustrative of issues that may be proposed under this program announcement. The examples provided are not meant to be exhaustive, and it is anticipated that other types of important studies will be proposed by researchers who respond to this announcement. Cost of Illness. Cost of mental illness studies assist policy makers in setting priorities in medical research and mental health care services development. An example of such studies is the estimation of the total economic impact of specific mental disorders, including the direct costs of treatment of patients suffering from these illnesses and the indirect costs associated with loss of earnings due to reduced or lost productivity. Cost-effectiveness. There is an increasing awareness that if a mental health treatment is to be adopted into mainstream clinical practice, cost-effectiveness needs to be addressed. Examples of studies in this area include cost-benefit, cost-effectiveness, and cost-utility analysis of innovative treatment methods (including new treatment methods for children and adolescents), systems of care, and new financing mechanisms for mental disorders. Health Insurance. Insurance benefit studies provide important insight into how covered services are meeting the medical treatment needs of the mentally ill and how such benefit programs affect the patients, the providers, and the payers of mental health care. Examples of research topics include effects of specific insurance coverage restrictions on access to and delivery of mental health care, and analysis of the impact of cost-containment strategies (including managed mental health care and capitation experiments) on outcome and quality of mental health care. Financing of Services. Research is needed on financing of public and private mental health services or systems and how financing policies govern resource allocation, access to services, and quality of mental health care. Examples of such studies include analysis of strategies and mechanisms employed by State mental health agencies and other public agencies for financing services for the severely mentally ill and analysis of private sector financing of mental health services. Payment Mechanisms. Payment mechanisms influence the delivery, accessibility, use, cost, and quality of mental health services. Examples of such studies include studies on health care reform initiatives, including competition in the mental health care system and analysis of privatization of publicly provided mental health services. Methodological Research. Research is encouraged that will develop and test the application of new methods of economic analysis in mental health services research. Examples of such research may include development of risk-adjusted capitation rates, risk sharing, and reinsurance mechanisms and development of simulation models that advance understanding of the financing of system-wide linkages in mental health care. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population

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must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. Protection of Human Subjects The Department of Health and Human Services has regulations for the protection of human subjects and has developed additional regulations for the protection of children. A copy of these regulations (45 CFR 46, Protection of Human Subjects) and those pertaining specifically to children are available from the Office of Protection from Research Risks, National Institutes of Health, Bethesda, MD 20892, telephone 301/496-7041. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). The PA number and the title of this announcement must be typed in item number 2a on the face page of the PHS 398 application form. Applicants must also specify which support mechanism they are applying under, e.g., FIRST, small grant, R10. A limit of 25 pages applies to Sections A through D for R01 and R29 grant applications. For small grant applications, there is a limit of 10 pages. Applications exceeding the specified page limits will be returned. Applicants should note that FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Application kits containing the necessary forms may be obtained from offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the following office may be contacted for the necessary application material: Grants Management Branch, National Institute of Mental Health, 5600 Fishers Lane, Room 7C-05, Rockville, MD 20857, telephone 301/443-4414. The signed original and five exact, clear, single-sided photocopies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Detailed instructions are included in the application kits. All applications must clearly indicate the relevance of the proposed work to the stated purpose of this program announcement. REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit by an Initial Review Group (IRG) composed primarily of non-Federal scientific experts. Final review is by an appropriate national advisory council; review by Council may be based on policy considerations as well as scientific merit. By law, only applications recommended by the Council may be considered for funding. Summaries of IRG recommendations are sent to applicants following completion of the IRG review. Review Criteria General criteria used in the review of all applications include: o Significance and originality of the research from a scientific and technical viewpoint o Adequacy of the theoretical and conceptual framework of the proposed research and appropriateness of research methods o Demonstrated access to research subjects or data to conduct the research o Demonstrated research capability, experience, and level of commitment of the research staff o Adequacy of facilities, general environment, and core resources for the development and implementation of the proposed research o Evidence of cooperation and commitment from persons and/or organizations whose support is essential for the conduct of the research; appropriateness of the collaborative arrangements o Adequacy of the plan to protect research subjects o Appropriateness of the proposed budget and duration in relation to the proposed research o Conformance of the application to NIH policy on inclusion of women and minorities in study populations o Potential contribution of the research study to the current national health care reform initiatives Applications will be reviewed in accordance with the regular review schedule. NOTE: Receipt dates for Investigator-Initiated Interactive Research Project Grants (IRPG) are: October 15, February 15, June 15. AWARD CRITERIA Applications recommended by a National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, program needs and balance, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding scientific and programmatic issues may be directed to: Agnes Rupp, Ph.D. Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-4233 FAX: (301) 443-4045 Inquiries regarding fiscal matters may be directed to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-15 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. 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. .

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