Full Text MH-95-001 SERVICES RESEARCH SUPPLEMENTS TO CLINICAL THERAPEUTIC GRANTS NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: MH-95-001 P.T. 34 Keywords: Mental Disorders 0730057 National Institute of Mental Health Letter of Intent Receipt Date: April 15, 1995 Application Receipt Date: May 5, 1995 PURPOSE The National Institute of Mental Health (NIMH) announces the continued availability 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 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 RFA, Services Research Supplement to Clinical Therapeutic Grants, is related to the priority areas 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 These supplemental applications will only be considered for currently funded NIMH grants with at least one year remaining at the time of award, and ending no later than June 30, 1998. Applicants who previously submitted supplemental applications in response to the original RFA are eligible to resubmit. Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospital, 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. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) competitive supplement (S01) mechanism and can supplement the following types of grants: R01, R10, R37, P01, P20, P30, P50. PHS policy prohibits any foreign institution from applying for a P mechanism. 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 may not exceed the total costs of the prior year of the parent grant. RESEARCH OBJECTIVES 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 which best match the patient's/client's needs o Studies that measure an expanded range of outcomes (beyond symptom reduction), such as functional capacity, quality of life, or cost o Financing and cost issues relating to therapeutic interventions, e.g., cost-effectiveness, cost-benefit, and cost-utility research SPECIAL REQUIREMENTS o Supplemental requests should address the need to establish the effectiveness of efficacious treatments, thereby increasing the generalizability of research findings. o Supplemental funds may be used for expenses clearly related and necessary to conduct the proposed additional services research, including both direct and allowable indirect costs. o 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. INCLUSION OF WOMEN 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 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 15, 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 NIMH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Robert F. Prien at the address listed under INQUIRIES. 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 and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/710-0267. 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. 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Mary Lou Prince 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 Applications must be received by May 5, 1995. If an application is received after this date, it will be returned to the applicant without review. The Division of Research Grants (DRG) 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 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 the NIMH. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG 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 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 the NIMH in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration, and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria o Ability to 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). o Capability to expand and complement an existing parent grant o Scientific, technical, or medical significance and originality of proposed research o Appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research o Qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research o Availability of the resources necessary to perform the research o Appropriateness of the proposed budget and duration in relation to the proposed research 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. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications recommended for further consideration by the National Advisory Mental Health Council will be considered for funding on the basis of overall scientific and technical merit of the proposal as determined by peer review, appropriateness of budget estimates, program needs and balance, policy consideration, adequacy of provisions for the protection of human subjects, and availability of funds. Upon completion of the project's period of award made under this RFA, grantees may submit competitive renewal applications. 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: 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 Email: rprien@aoamh4.ssw.dhhs.gov 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 Email: gniedere.aoamh4.ssw.dhhs.gov 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 Email: pjensen.aoamh4.ssw.dhhs.gov Kathryn Magruder, Ph.D., M.P.H. 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 Email: kmagrude.aoamh2.ssw.dhhs.gov Direct inquiries regarding fiscal matters 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 Email: dtrunnel.aoamh1.ssw.dhhs.gov 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, a 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. .
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