Full Text MH-94-008 SERVICES RESEARCH COMPETITIVE SUPPLEMENTS TO CLINICAL THERAPEUTIC RESEARCH GRANTS NIH GUIDE, Volume 23, Number 14, April 8, 1994 RFA: MH-94-008 P.T. Keywords: National Institute of Mental Health Letter of Intent Receipt Date: May 8, 1994 Application Receipt Date: June 8, 1994 PURPOSE The National Institute of Mental Health (NIMH) announces the availability of support in the form of competitive supplements to expand ongoing funded clinical therapeutic research grants into the area of services research. The purpose of these supplements is to help move mental health treatments from the testing of efficacy (i.e., whether the treatment works under highly controlled conditions in a population with a well defined mental disorder) into testing of effectiveness (i.e., whether the same promising treatment works when applied to a wider and diverse range of settings, providers, populations, and outcome assessment). Services research is a major NIMH priority and is responsive to Public Law 102-321 (July 10, 1992), which requires the NIMH to obligate not less than 15 percent of its budget to health services research. 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 Request for Applications (RFA), Services Research Competitive Supplements to Clinical Therapeutic Research Grants, 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 will only be considered for currently funded grants with at least one year remaining, ending no later than March 30, 1996. Such funding could be supplementary to a competitive renewal grant. Women and minority investigators are encouraged to apply. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) competitive supplement mechanism (S01) and can supplement the following types of grants: R01, R10, R37, P01, P20, P30, P50. Supplemental request may not exceed the tenure left on the parent grant. Annual awards will be made, subject to continued availability of funds and progress achieved. FUNDS AVAILABLE It is anticipated that at least $1,000,000 in direct costs will be made available. Awards will have a maximum yearly direct cost amount of $200,000, but will not exceed the total costs of the prior year of the parent grant. RESEARCH OBJECTIVES Background Despite the upsurge of research on the treatment of mental illness, both within the NIMH and in the field, there are still critical needs that were highlighted in a recent report by the NIMH Treatment Research Initiative Task Force. The basic goal of the initiative is to take advantage of emerging knowledge and technology to develop and refine more efficient and effective treatment programs for individuals with mental illness. Specific recommendations include (1) development of more effective treatments for patients who fail to respond to standard therapies; (2) enhanced research on the treatment of chronic or recurrent mental illness; (3) strengthening research directed at populations that are not often the focus of treatment research; (4) improved criteria and instruments for assessing a wider range of treatment outcomes and; (5) development of more effective integrated interventions involving biological, psychosocial, and rehabilitative therapies. The report places special emphasis on strengthening the linkage between clinical therapeutic research and clinical services research in advancing the effective use of available treatments in clinical practice. The aim of this RFA is to encourage the transition from clinical therapeutic efficacy research into clinical services effectiveness research (NIMH Caring for People with Severe Mental Disorders: A National Plan of Research to Improve Services. DHHS Pub. No. (ADM 91-1762. Washington, DC: Superintendent of Documents, U.S. Government Printing Office, 1991), thereby expanding the generalizability of the intervention. Ultimately, this transition should result in improved outcomes and increased numbers of individuals benefiting from promising mental health treatments. Following are examples of the types of clinical services research issues that would benefit from expansion of ongoing clinical therapeutic research grants. The list is illustrative rather than comprehensive. It is expected that additional relevant and important research topics will be identified by investigators responding to this RFA. o Studies testing promising treatments with new populations, such as racial or ethnic minorities, patients with co-occurring mental, substance abuse, or medical conditions. o Studies testing the effectiveness of proven mental health treatments when employed in everyday practice and settings (e.g., primary care settings, nursing homes, community mental health centers, outpatient clinics) o Studies testing the effectiveness of proven mental health treatments when administered by providers who more fully represent the range and expertise of providers expected to deliver the treatment in everyday practice and settings o Studies of the delivery of treatment, such as how to provide coordinated treatment and rehabilitation services and select modalities that best match the patient's/client's needs. o Studies that measure an expanded range of outcomes (beyond symptom reduction), such as functional capacity, and quality of life, or cost. o Financing and cost issues relating to therapeutic interventions, e.g., cost-effectiveness, cost-benefit, and cost-utility research. Program Specifications Supplementary requests should address the need to establish the effectiveness of efficacious treatments, thereby increasing the generalizability of research findings. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF FEMALES AND MINORITIES IN RESEARCH STUDY POPULATIONS It is the policy of the NIH that women and member 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) 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 59 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. LETTER OF INTENT Prospective applicants are asked to submit, by May 8, 1994, a letter of intent. This should include the title and number of the parent grant to be supplemented 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 is helpful in planning for the review of applications. It allows NIMH 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 Dr. Robert Prien at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are to use the grant applications form PHS 398 (rev. 9/91). Application kits containing the necessary forms and instructions for regular research grants may be obtained from the office of sponsored research at most universities, colleges, medical schools, and other major research facilities; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from the program office listed under INQUIRIES. The RFA label available 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 of the face page of the application form and the YES box must be marked. The signed original and five legible copies of the completed application must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Schedule Letter of Intent Receipt Date: May 8, 1994 Application Receipt Date: June 8, 1994 IRG Review: July/August 1994 Council Review: September 1994 Approximate Start Date: September 1994 Terms and Conditions of Support Supplemental funds may be used for expenses clearly related and necessary to conduct the proposed supplemental services research, including both direct and allowable indirect costs. Supplemental funds may not be used to operate a treatment, rehabilitation, or other service program, nor may such funds be used to fund research that is an integral part of the parent grant. Public-Academic Liaison As part of the NIMH Public-Academic Liaison (PAL) initiative, special encouragement is given to applications that involve active collaborations between academic researchers and public sector agencies in planning, undertaking, analyzing, and publishing research pertaining to people with severe mental disorders. The PAL initiative is based upon the premise that important new advances in the understanding and treatment of severe mental illness can result from improved linkages between the Nation's scientific resources and the public sector agencies and programs in which many people with severe mental disorders receive their care. The scope of the PAL initiative encompasses public sector agencies of all types that provide services for people with severe mental disorders. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness and responsiveness. Incomplete or nonresponsive applications will be returned to the applicant without further consideration. Applications will be reviewed for scientific and technical merit by an NIMH 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 discussions are sent to applicants as soon as possible following IRG review. Review Criteria Criteria for scientific/technical merit review of applications will include the following: significance of the goals of the proposed research plan and its relationship to the parent grant; evidence of familiarity with relevant research literature; adequacy of the conceptual and theoretical framework for the research; adequacy of the methodology proposed to carry out the research; feasibility of the proposed research; qualifications and research experience of the principal investigator and other key research personnel; availability of adequate facilities, other resources, and collaborative arrangements necessary for the research; appropriateness of budget estimates for the proposed research activities; adequacy of plans to include women and minorities in study populations; and adequacy of provisions for the protection of human subjects and the welfare of animal subjects, as applicable. AWARD CRITERIA In granting awards, the following criteria are consider: program relevance, quality of application as documented by IRG and Council recommendation, and program balance. INQUIRES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic is and address the letter of intent to: Robert F. Prien, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Matthew V. Rudorfer, M.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 Barry E. Wolfe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-4527 FAX: (301) 443-6000 George Niederehe, Ph.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-1185 FAX: (301) 594-6784 Peter S. Jensen, M.D. Division of Clinical and Treatment Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-5944 FAX: (301) 443-6000 Thomas Lalley Division of Epidemiology and Services Research National Institute of Mental Health 5600 Fishers Lane, Room 10C-06 Rockville, MD 20857 Telephone: (301) 443-3364 FAX: (301) 443-4045 Direct inquiries regarding grants management issues to: Diana Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 AUTHORITY AND REGULATION 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 PSC 241 and 285) and administered under PHS grants and Federal Regulations 42 CFR, Part 52 "Grants for Research Projects" and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Execute Order 12372. The Public Health Service (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. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |