GUIDELINES FOR APPLICATIONS INVOLVING CLINICAL RESEARCH WITH YEARLY DIRECT COSTS OVER $1,000,000 Release Date: June 25, 2001 (see correction NOT-NS-03-025) NOTICE: NOT-NS-01-012 National Institute of Neurological Disorders and Stroke PURPOSE Current NIH-wide policy states that programmatic acceptance is required for all unsolicited grant applications requesting $500,000 or more in direct costs for any year, including new (Type 1), competing continuation (Type 2), competing supplement and any amended/revised version of the preceding grant application types ( Acceptance For Review Of Unsolicited Applications That Request More Than $500,000 Direct Costs http://grants.nih.gov/grants/guide/notice-files/not98-030.html). The guidelines and procedures for programmatic acceptance of unsolicited clinical research grant applications requesting direct costs of $1,000,000 or more in any year by the National Institute of Neurological Disorders and Stroke (NINDS) are outlined in the present document. For purposes of this policy clinical research is as defined in the 1997 Report of the NIH Director’s panel on Clinical Research http://www.nih.gov/news/crp/97report/execsum.htm). According to this definition, clinical research includes (a) Patient-oriented research (including research on the mechanisms of human disease, therapeutic interventions, clinical trials, and the development of new technologies), (b) Epidemiologic and behavioral studies, and (c) Outcomes research and health services research. Excluded from this definition are in vitro research studies that utilize human tissue that cannot be linked to a living individual or research that does not involve human participants. The current policy is intended to meet NINDS commitment toward developing its clinical research program (as identified in the NINDS strategic planning process http://www.ninds.nih.gov/about_ninds/plans/strategic_plan.htm) by standardizing the process of accepting an investigator’s request to submit an unsolicited clinical grant application requesting direct costs of $1,000,000 or more in any year. It also ensures that the NINDS staff has sufficient information and time necessary to make an informed decision to accept an application for review. Obtaining NINDS agreement to accept an application does not guarantee funding. As with all grant applications, the decision to make an award depends upon the results of independent peer review for technical/scientific merit, a subsequent recommendation of approval by the National Advisory Neurological Disorders and Stroke (NANDS) Council, and availability of funds. It is in everyone’s best interest that potential applicants planning an application that requests unusually high direct costs contact the NINDS program staff as early as possible. Potential applicant(s) may also request a meeting between the NINDS and the investigator(s) to discuss the proposed project. POLICY An applicant planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or an amended/revised version of the preceding grant application types for a clinical research project requesting $1,000,000 or more in direct costs for any year is advised that he or she must contact the NINDS (see INQURIES) a minimum of 3 months prior to the next submission deadline for new grant applications (Feb 1, June 1, or Oct 1). Furthermore, the applicant must obtain agreement from the NINDS staff that the Institute will accept the application for consideration for award. Any application subject to this policy that does not receive permission to submit will be returned to the applicant without review. These guidelines apply to unsolicited grant applications (e.g., R01, U01, U54, P01, P50), including applications submitted in response to NINDS Program Announcements (PAs). They do not, however, apply to grant applications that are submitted in response to NINDS Requests For Applications (RFAs). Solicitations for SBIR or STTR applications are also excluded from this policy. Approval for submission of these applications is sought directly from the appropriate NINDS Program Director. PROCEDURES An applicant planning to submit a grant application to which this policy applies is required to contact Dr. Scott Janis (see INQUIRES) no later than 90 days before the application receipt date (November 1 for the February 1 receipt date, March 1 for the June 1 receipt date, or July 1 for the October 1 receipt date). Prospective applicants are asked to submit a letter of intent that should include a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, and identities of other key personnel and participating institutions. Although a letter of intent is not binding and does not enter into the review of subsequent applications, the information allows NINDS staff sufficient time necessary to make an informed decision to accept an application for review. A response will be sent to the potential applicant no later than 6 weeks prior to the requested submission deadline. If the NINDS is willing to accept assignment of the application for consideration of funding, the staff will notify the Center for Scientific Review before the application is submitted. EFFECTIVE DATE: June 1, 2001 INQUIRIES Submit all requests for applications subject to this policy to: Scott Janis, Ph.D. National Institute of Neurological Disorders & Stroke National Institutes of Health 6001 Executive Boulevard, Rm. 2209, MSC 9525 Bethesda, MD 20892-9525 (301) 594-0211 (301) 480-1080 Fax email: sj151t@nih.gov


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