RESEARCH INFRASTRUCTURE SUPPORT PROGRAM NIH GUIDE, Volume 21, Number 35, October 2, 1992 PA AVAILABLE: PA-93-003 P.T. 14 Keywords: Mental Disorders Clinical Medicine, General Biomedical Research, Multidiscipl National Institute of Mental Health THE PROGRAM ANNOUNCEMENT (PA) ANNOUNCED IN THIS NOTICE CONTAINS ESSENTIAL INFORMATION FOR THE PREPARATION OF AN APPLICATION. POTENTIAL APPLICANTS MAY OBTAIN THE PROGRAM ANNOUNCEMENT FROM THE CONTACT NAMED IN INQUIRIES, BELOW. PURPOSE The National Institute of Mental Health (NIMH) is committed to expanding the number of institutions capable of supporting state-of-the-art clinical and services research and thus increasing the number of investigators obtaining extramural funding for their research. Expansion of the clinical research infrastructure is a major priority of the NIMH; the Research Infrastructure Support Program (RISP) is a direct response of the NIMH to recommendations made by the National Advisory Mental Health Council and by the NIMH Extramural Science Advisory Board. The purpose of this PA is to stimulate the development of new resources at institutions capable of developing and maintaining programs of clinical and services research directed at the major mental disorders. 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. The PA, Research Infrastructure Support Program, 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 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 public and private, non-profit and for-profit organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government, except for those institutions with NIMH research support exceeding $3,000,000 (in total costs) in fiscal year 1991. Women and minorities are encouraged to apply. MECHANISM OF SUPPORT Grants awarded in the RISP program will use the Resource-Related Research Project mechanism (R24) to contribute to the improvement of the capability of resources to serve biomedical research. RESEARCH OBJECTIVES Many institutions with access to large and varied populations of individuals with mental disorders are not able to launch research programs because of limited technical and scientific support available within their research environment. This program will assist in the development of these and other resources that will form part of the institution's clinical research infrastructure. Applicant institutions must describe a comprehensive and coherent plan of improvement to the institution's current research environment that will expand the capacity of investigators at the institution to carry out extramurally supported mental health research. The plan must have a focus on particular mental health clinical populations or diagnostic groups and must demonstrate accessibility of the population to institution-based investigators. The plan must also demonstrate the actual commitment of institutional resources which may include senior faculty release time, support staff, research bed costs, equipment costs assumed by the institution, and waiver of overhead costs. A central philosophical principle underlying this program is that different institutions will require different types of infrastructure development activities and initiatives. Therefore, this announcement does not prescribe in any detail the nature of the activities to be applied for or supported. The following types of support may be requested under this program: o Partial salary support for junior faculty, particularly women and minorities o Training expenses for junior faculty o Research patient recruitment, diagnosis, assessment, and follow-up o Clinical and scientific consultation, including expenses incurred by an external review and scientific advisory committee o Biostatistical and data-base management services o Small equipment and research instruments o Research technicians and assistants o Developmental, feasibility, or pilot studies STUDY POPULATIONS NIH POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements and proposals for contracts that involve human subjects are required to include minorities and both genders 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 applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. 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. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, the 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., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. The composition of the proposed study population 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 must be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. All applications for clinical research submitted to the NIH are required to address these policies. NIH funding components will not award grants that do not comply with these policies. APPLICATION PROCEDURES Applicants are to use the research grant application form PHS 398 (rev. 9/91) in applying for these grants. The number and title of this PA, Research Infrastructure Support Program, must be typed in item 2a on the face page of the PHS application form. Applications kits containing the necessary forms and instructions may be obtained from business offices and offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the necessary application materials may be obtained from the 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 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** REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit by an initial review group (IRG) composed of primarily 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 by the Council may be considered for funding. Summary statements of IRG discussions are sent to applicants as soon as possible following IRG review. Review Criteria o Past research training record for both the program and the designated preceptors in terms of the rate at which former trainees establish independent and productive research careers o Past research training record in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards, and research grants for further development o Objectives, design, and direction of the research training program o Caliber of preceptors as researchers including successful competetion for research support o Training environment including the institutional commitment, the quality of the facilities, and the availability of research support o Recruitment and selection plans for appointees and the availability of high quality candidates o The record of the research training program in retaining health- professional post-doctoral trainees for at least two years in research training or other research activities o When appropriate, the concomitant training of health-professional post-doctorates (e.g., individuals with the M.D., D.O., D.D.S.) with basic science post-doctorates (e.g., individuals with a Ph.D., Sc.D.) will receive special consideration Following scientific-technical review, the application will receive a second-level review by the appropriate National Advisory Council. AWARD CRITERIA Applications recommended for approval by the appropriate 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 concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Grayson S. Norquist, M.D., M.S.P.H. Deputy Director, Division of Epidemiology and Services Research National Institute of Mental Health Parklawn Building, Room 18C-26 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3683 Direct inquiries regarding fiscal matters to: Stephen J. Hudak Chief, Grants Management Section National Institute of Mental Health Parklawn Building, Room 7C-23 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4456 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3. 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 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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