and Human Services (HHS)
ANCILLARY STUDIES TO NIMH MULTI-SITE CLINICAL TRIALS CLARIFICATION OF PROCEDURES AND RECEIPT DATES Release Date: November 15, 2001 NOTICE: NOT-MH-01-005 National Institute of Mental Health (http://www.nimh.nih.gov/) On May 17, 2000, the National Institute of Mental Health (NIMH) issued PAR- 00-095, "Ancillary Studies to NIMH Multi-Site Clinical Trials," located at http://grants.nih.gov/grants/guide/pa-files/PAR-00-095.html. This PAR invited applications for ancillary studies to extend the utility of multi- site clinical trials (in schizophrenia, Alzheimer's disease, bipolar disorder, treatment resistant depression, and adolescent depression) supported by NIMH contracts. Information about these trials is available on the NIMH website at http://www.nimh.nih.gov/studies/index.cfm. At the same time, NIMH issued a Notice, MH-00-009, "Ancillary Studies In NIMH Multi-Site Clinical Trials: Career Development Awards," located at http://grants.nih.gov/grants/guide/notice-files/NOT-MH-00-009.html, encouraging persons interested in Career Development Programs to consider ancillary studies as part of their application submitted under one of the Career Development announcements. More recently, NIMH issued MH-00-012, "Ancillary Studies To NIMH Multi-Site Clinical Trials Change In Receipt Dates," located at http://grants.nih.gov/grants/guide/notice-files/NOT-MH-00-012.html, announcing that applications submitted under PAR-00-095 could be accepted on a monthly basis. The purpose of this notice is to clarify procedures for PAR-00-095. Each NIMH-supported trial has now established an Ancillary Study Committee (ASC) to review proposed projects for appropriateness and compatibility with the parent clinical trial. The trials' ASC policies and procedures are available at http://www.catie.unc.edu/ for schizophrenia and Alzheimer's disease; http://www.stepbd.org/ for bipolar disorder; http://www.edc.gsph.pitt.edu/stard/for treatment resistant depression; and http://trialweb.dcri.duke.edu/tads/index.html for adolescent depression. The trial ASC will serve as the point of initial submission for investigators interested in an ancillary study, and will continue to be responsible for processing the initial concept for an ancillary study. However, prior to submitting a concept to the trial's ASC, investigators are encouraged to contact the NIMH program staff listed under INQUIRIES to discuss their proposed projects, programmatic interest, potential overlap, and other issues. An investigator will submit the concept for an ancillary study to the ASC of the appropriate trial. Before the ASC reviews any concept, it submits it to the trial's NIMH Government Project Officer (GPO). The NIMH GPO will consult with the appropriate NIMH scientific program staff to evaluate the proposed concept for compatibility with Institute priorities, as well as the project's unique contribution to and feasibility of incorporation into the trial. Program staff also will determine whether expedited peer review is necessary based on the scientific goals of the proposed concept and the parent trial. Once NIMH decides whether to accept the proposed concept for ASC review, the investigator will be notified by the ASC of this and of subsequent determinations. Since the ASC review process may result in significant changes in the study design, the finalized ASC approved concept will be submitted for final approval by the ASC to the NIMH GPO, who will again consult with appropriate NIMH program staff. NIMH must give its consent before a proposed concept for an ancillary study can be implemented within an NIMH supported clinical trial regardless of the funding source. Proposed concepts that did not receive approval from NIMH or the ASC may be revised and resubmitted to the ASC. The requirements noted above apply to all proposed ancillary studies, including those of contract site researchers and those projects that involve only one clinical site, regardless of funding source. Grant applications that seek NIMH funding for ancillary studies will not be accepted for peer review unless accompanied by the ASC approved concept letter. Those grant applications based on ASC-approved concepts seeking NIMH support and approved for expedited review by NIMH program staff should be submitted for the monthly receipt date (the 9th of each month) and will be reviewed by a Special Emphasis Panel (SEP or special review group) in an expedited manner. A letter of approval for expedited review should be included in the application that is submitted for NIH peer review. Those grant applications based on ASC-approved concepts that staff determines do not require expedited review should be submitted on the standard receipt dates (http://grants.nih.gov/grants/funding/submissionschedule.htm) and will also be assigned following the standard referral and review guidelines. For those applications to receive funding outside the NIMH, program staff will assess the need for additional scientific review on a case by case basis. SPECIFIC INFORMATION FOR GENETIC ANCILLARY STUDIES It has become clear that many researchers are interested in ancillary genetic studies. To meet this significant need and to minimize the demand on participants, NIMH will modify the contracts to coordinate the participant contacts, consent procedures, blood draws, and establishment of cell lines. A modification to the contracts for each of five multisite trials in schizophrenia (CATIE: N01 MH90001), Alzheimer's disease (CATIE: N01 MH90001), bipolar disorder (STEP-BD; N01 MH80001), treatment resistant depression (STAR*D: N01 MH90003), and adolescent depression (TADS: N01 MH80008) is currently being made to collect and distribute genetic materials to the scientific community. Investigators are encouraged to collaborate with the contract trial staff to eliminate redundancies with other funded projects in their proposed ancillary studies and to optimize use of these anticipated shared resources. Some investigators may wish to conduct ancillary genetic studies that require data or biomaterials not already being collected. One such genetic study, for example, may require collection of DNA from relatives of trial participants. The approval and submission processes described above all apply to genetic ancillary studies, except that ancillary genetic applications seeking NIMH support will NOT be accepted for expedited review with monthly receipt. The invesigator should submit according to standard NIH application receipt, referral, and review guidelines (see http://grants.nih.gov/grants/funding/submissionschedule.htm). A small number of concepts for ancillary genetic studies have been approved by one of the trial ASCs. The ASC will now forward these concepts for approval to the NIMH GPO who will consult with the genetics program staff listed below under INQUIRIES. INQUIRIES Direct inquiries regarding issues related to NIMH clinical trials as well as scientific issues related to programs in the Division of Services and Interventions Research to: John K. Hsiao, M.D. Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, Room 7160, MSC 9635 Bethesda, MD 20892-9635 Telephone: (301) 443-1185 FAX: (301) 594-6784 Email: [email protected] Direct inquiries regarding scientific issues related to programs in the Division of Mental Disorders, Behavioral Research and AIDS to: Bruce N. Cuthbert, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6184, MSC 9625 Bethesda, MD 20892-9625 Telephone: (301) 443-3728 FAX: (301) 443-4611 Email: [email protected] Direct inquiries regarding scientific issues related to non-genetic programs in the Division of Neuroscience and Basic Behavioral Science to: Steven J. Zalcman, M.D. Division of Neuroscience and Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7177, MSC 9639 Bethesda, MD 20892-9639 Telephone: (301) 443-1692 FAX: (301) 443-4822 Email: [email protected] Direct inquiries regarding scientific issues related to genetics in the Division of Neuroscience and Basic Behavioral Science to: Steven O. Moldin, Ph.D. Division of Neuroscience & Basic Behavioral Science National Institute of Mental Health 6001 Executive Boulevard, Room 7189, MSC 9643 Bethesda, MD 20892-9643 Telephone: (301) 443-2037 FAX: (301) 443-9890 Email: [email protected] Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: [email protected]
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