PILOT EFFECTIVENESS TRIALS FOR MENTAL DISORDERS Release Date: June 23, 1999 (see replacement PAR-03-078) PA NUMBER: PAR-99-118 National Institute of Mental Health Application Receipt Dates: October 1, February 1, and June 1 THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. PURPOSE The National Institute of Mental Health (NIMH) is committed to promoting a public health model for prevention, intervention, and rehabilitation research that evaluates interventions for mental disorders through well-designed effectiveness trials. A vital aspect of this process involves pilot studies of the proposed interventions. Before proceeding to full-scale effectiveness trials, pilot studies are generally required to estimate parameters such as effect size and population variance that are essential for large scale trial design. The NIMH announces its interest in supporting pilot studies required to establish solid foundations for rational design and execution of full-scale effectiveness trials. The purpose of NIMH Pilot Effectiveness Trials Program for Mental Disorders is to obtain needed preliminary data and conduct studies to support subsequent effectiveness trials of interventions for mental disorders of children and adults. This is part of a series of four program announcements making up a broad scale public health oriented intervention research. The other three program announcements are NIMH THERAPEUTIC EFFECTIVENESS PROTOCOL DEVELOPMENT PROGRAM (PAR-99-119), NIMH POSTDOCTORAL RESEARCH TRAINING IN INTERVENTION TRIALS (PA-99-072), and INTERVENTIONS INFRASTRUCTURE PROGRAM (PAR-99-064). 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, Pilot Effectiveness Trials For Mental Disorders, is related to the priority area of mental health and mental disorders. Potential applicants may obtain a copy of "Healthy People 2000" http://odphp.osophs.dhhs.gov/pubs/hp2000 ELIGIBILITY REQUIREMENTS Applications may be submitted by 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanism of support will be the Exploratory/Developmental Planning Grant (R21) of the National Institutes of Health, which will provide up to a maximum of $125,000 in direct cost per year for up to three years. Applicable Facilities and Administrative (formerly known as indirect costs) will be applied. The award is not renewable. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://www.nih.gov/grants/funding/modular/modular.htm RESEARCH OBJECTIVES The research project should directly address how the pilot study will establish the foundation for subsequent design and implementation of a full- scale effectiveness trial. The study should produce data on effect size, safety, dosage, and population variance that can subsequently be utilized in power analysis and other aspects of full-scale effectiveness trial design. The application should also address the intrinsic scientific merit of the study conducted under the Pilot Grant, whether or not a full-scale trial is performed. The NIMH Pilot Effectiveness Trials Program may include studies of pharmacological interventions meeting the following broad objectives: Studies to broaden an existing preventive or treatment intervention strategy (dosage, duration, delivery system) Studies to broaden the target population of an existing preventive or treatment intervention Studies to broaden the functional and quality of life outcomes of existing intervention strategies Collection of preliminary data that establish efficacy and safety of novel intervention strategies Studies to extend an ongoing or completed efficacy study to a broader scale effectiveness trial 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: http://www.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under that the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program staff listed under INQUIRIES with any questions regarding their proposed project and the goals of this PA. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. The standard application deadlines as indicated in the application kit should be followed. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at: http://www.nih.gov/grants/forms.htm The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $125,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $125,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://www.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://www.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations; o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this PA and will be returned without further review. The title and number of the program announcement must be typed in Section 2 on the face page of the application. As with most applications to NIH, the research plan is limited to 25 pages. All information for review of the NIMH Clinical Trial Planning Grant application must be included in the body of the application; appendices will not be considered during the review for this mechanism. The completed original application and three legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892 BETHESDA, MD 20817 (for express/courier service) Two additional copies must be sent or delivered to: Henry J. Haigler, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9608 Bethesda, MD 20892-9608 REVIEW CONSIDERATIONS Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIMH in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria for research grant applications: The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in the assignment of the overall score. (1) Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? The scientific basis for the proposed intervention should include discussion of current practice and alternative interventions. (2) Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? The following should also be addressed: (a) Study Design and Procedures. - Translation of the clinical question into statistical hypotheses - Selection of outcome measure(s) - Inclusion and exclusion criteria - Ability of the study to answer secondary questions - Ability of the study to generate new hypotheses for subsequent investigation - Ethical and safety issues, and quality control procedures (b) Data Analysis - Specific methods to be used for data analysis - Although the sample size for a pilot study may not be adequate to detect small treatment effects, the data from this study should provide a basis for subsequent power analysis for future trials. - Population and demographics of the clinical condition (3) Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project have the potential to change existing practice? (4) Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? (5) Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? (6) Appropriateness of the proposed budget and duration in relation to the proposed research; (7) Adequacy of plans to include genders, children and adolescents, and minorities and their subgroups as appropriate for the scientific goals of the research, or justification for their exclusion. 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 subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquiries regarding programmatic issues to: Herbert W. Harris, M.D., Ph.D. (Adult and Geriatric) National Institute of Mental Health 6001 Executive Blvd. Room 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-9125 FAX: (301) 594-6784 Email: hharris@mail.nih.gov Benedetto Vitiello, M.D. (child and adolescent) National Institute of Mental Health 6001 Executive Blvd. Room 7149, MSC 9633 Bethesda, MD 20892-9633 Telephone: (301) 443-4283 FAX: (301) 443-4045 Email: bvitiell@mail.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Blvd., Room 6115 MSC 9605 Bethesda, MD 20892-9635 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov 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 inter-governmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under NIH Grants Policy Statement (effective October 1, 1998). PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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