RESEARCH ON METHODS IN MENTAL HEALTH RESEARCH NIH GUIDE, Volume 23, Number 16, April 29, 1994 PA NUMBER: PA-94-060 P.T. Keywords: National Institute of Mental Health PURPOSE The purpose of this program announcement is to encourage research grant applications for work on the design, measurement, and statistical challenges inherent in conducting mental health research. The goal of this initiative is to build the methodological infrastructure of mental health research by encouraging statisticians, psychometricians, and other experts in research methodology and data analysis to focus on these challenges. This program announcement addresses recommendations set forth in the Clinical Services Research section of Caring for People with Severe Mental Disorders: A National Plan of Research to Improve Services and in earlier National Institute of Mental Health (NIMH) initiatives relating to specific populations and disorders, including children and adolescents, the elderly, rural populations, and schizophrenia. 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 program announcement, Research on Methods in Mental Health Research, 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 REQUIREMENTS 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 or local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Research support may be requested through applications for regular research grants (R01), small grants (R03), and FIRST awards (R29). Since the R03 and R29 mechanisms have special requirements regarding eligibility, application format, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and obtain specialized announcements. Applications may request support for up to five years for regular research. Small grants are limited to two years and may not be renewed. FIRST awards are for five years, but are not renewable. Annual awards will be made, subject to continued availability of funds and progress achieved. Because the nature and scope of the research proposed in response to this program announcement will vary, it is anticipated that the size of the awards will also vary. RESEARCH OBJECTIVES Background. Advances in mental health research are highly dependent on the quality of research procedures, measures, and data analytic strategies available to investigators. As the knowledge base broadens and deepens, questions of increasing subtlety and complexity must be addressed. To do so requires the development or adaptation of increasingly more sophisticated and precise methods, measures, and analytic strategies. The NIMH is issuing this program announcement to ensure that statisticians, psychometricians, and other experts in research methodology and data analysis who are currently working on the methodological issues in mental health research will continue to do so and that those methodological experts who are not working on mental health issues will be encouraged to enter the field, bringing with them the insight that a fresh perspective can provide in finding solutions to problems. This program announcement makes explicit the determination of NIMH to support the basic methodological work necessary for the advancement of mental health research. Research Issues. Listed below are examples of research topic areas that focus on methods, measurement, and statistical analysis in mental health research. The list of examples is illustrative, not exhaustive; it is expected that additional important research topics will be identified by researchers who respond to this program announcement. Design, measurement, and data analytic topics relevant to any of the areas of inquiry funded by NIMH, including mental health services, epidemiologic, prevention, basic behavioral, brain, and clinical and treatment research, are encouraged. o Studies focusing on the development and refinement of instruments and procedures for assessing both stable and unstable characteristics of individuals (e.g., psychopathology, mental disorder, positive/adaptive personality functioning) and environments (e.g., stressful and supportive conditions of home, workplace, social networks, service systems), with particular attention to psychometric indices of reliability and validity, including susceptibility to response bias, gender differences, cultural relevance, and applicability to diverse study populations o Research concerning the development of new or improved data analytic strategies for handling the difficulties and challenges encountered in analyzing data from longitudinal studies o Research to develop design, assessment, and data analytic methods that address the shortcomings, for clinical decision making, of sample-based statistical conclusions o Studies bearing on the use and/or combination of data from multiple informants, including attention to (1) individual characteristics and environmental context, and (2) how the influences of these factors change as a function of the nature of the information reported o Studies of the reliability and validity of instruments in multiple outcome domains particularly for understudied populations, e.g., severely mentally ill persons who are homeless, minorities, rural residents, and severely emotionally disturbed children STUDY POPULATIONS INCLUSION OF FEMALES 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 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 new 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 9, 1994 (FR 11146-11151), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91). The number (PA-94-060) and the title of this program announcement, Research on Methods in Mental Health Research, must be typed in item number 2a on the face page of the PHS 398 application form. Applicants must also specify under which support mechanism they are applying: R01, R29, R03. 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 the office of sponsored research at most universities, colleges, medical schools, and other major research facilities or from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The signed original and five copies of the completed PHS 398 must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** 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 the appropriate National Advisory Council; review by Council may be based on policy considerations as well as scientific merit. By law, only applications recommended for consideration for funding by the Council may be supported. Summaries of IRG recommendations are sent to applicants as soon as possible following IRG review. Review Criteria. Criteria to be considered in evaluating R01 applications for scientific/technical merit include: o Scientific, technical, or medical significance and originality of the proposed research o Appropriateness and adequacy of the research approach and methodology proposed to carry out the research o Qualifications and research experience of the principal investigators and staff, particularly but not exclusively in the area of the proposed research o Availability of resources necessary to the research o Appropriateness of the proposed budget and duration in relation to the proposed research o Adequacy of the proposed means for protecting against or minimizing adverse effects to human and/or animal subjects Because the R03 and R29 mechanisms have some distinct review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and obtain specialized announcements. AWARD CRITERIA Factors considered in determining which applications will be funded include IRG and Council recommendations, PHS program needs and priorities, and availability of funds. As part of the NIMH Public-Academic Liaison (PAL) initiative, preference may be given to applications that involve active collaborations between academic researchers and public sector agencies in planning, undertaking, analyzing, and publishing research pertaining to persons with severe mental disorders. The PAL initiative is based on the premise that important new advances in understanding and treatment of severe mental disorders can result from improved linkages between the Nation's scientific resources and the public sector agencies and programs in which many persons with severe mental disorders receive their care. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ann A. Hohmann, Ph.D., M.P.H. Services Research Branch National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 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). Grants must be administered in accordance with the PHS Grants Policy Statement (Rev. October 1990). Federal Regulations at 42 CFR Part 52 and 66, "Grants for Research Projects" and 45 CFR Parts 74 [and 92 when applicable for State and local government.] This program is not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through DHHS regulations at 45 CFR Part 100, or Health Systems Agency review. .
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