TERMS AND CONDITIONS OF AWARD FOR LARGE SCALE UNSOLICITED RESEARCHPROJECT APPLICATIONS FOR CLINICAL TRIALS, PREVENTION AND CONTROL INTERVENTIONS, AND EPIDEMIOLOGICAL STUDIES NIH GUIDE, Volume 22, Number 43, November 26, 1993 P.T. 34 Keywords: Cancer/Carcinogenesis Grants Administration/Policy+ Clinical Trial Epidemiology Disease Prevention+ Disease Control+ National Cancer Institute The National Cancer Institute (NCI) announces that any new or competing continuation investigator-initiated clinical trial, prevention or control intervention, or epidemiological study in which direct costs exceed $500,000 in any year (at a single institution or in the aggregate for a study proposing multi-institutional collaborative arrangements submitted as either subcontracts to a single application or as separate applications) will usually be awarded only as a cooperative agreement (U01). For single applications, the dollar limit excludes indirect costs of any subcontracts that are reported as a direct cost on the application budget page summary. Separate U01 awards usually will be made for individual applications submitted concurrently by institutions proposing a study involving a coordinated research effort. In addition, studies falling under the above guidelines requesting in aggregate in excess of $1,000,000 in direct costs in any single year will be administratively evaluated by the NCI prior to peer review to determine if such a potential award(s) could be accommodated within the Institute's scientific and fiscal plans for that budget year. If a potential award of such scope cannot be contemplated, the application(s) will be returned without review. This policy is effective immediately with publication of this announcement and covers all current pending unfunded applications as well as all future submissions in these categories. The cooperative agreement is an assistance instrument similar in most ways to a grant. It differs in that, in addition to the standard stewardship role, an Institute extramural program director is expected to have a continuing substantive role in one or more scientific aspects of the study, in an assisting, not directing, relationship. The type and degree of such involvement is to be appropriate to the specific cooperative agreement. The awardee will have lead responsibilities in all aspects of study, including any modification of study design, conduct of study, quality control, and analysis of results. The Institute program director may have assistance roles in one or more of those areas and will have a shared lead responsibility in facilitating the interim data and safety monitoring. In order to facilitate the above interactions, it will be necessary for awardees to plan for periodic regular meetings with NCI staff in the Bethesda, MD area. Accordingly, respondents must request and will be allowed sufficient funds within the submitted budgets to accommodate expenses for participants at these meetings, as well as for expenses incurred in the conduct and monitoring of the trial. All awards made as cooperative agreements under the above circumstances shall be subject to the applicable terms of award. Specific terms, conditions, and arbitration procedures pertaining to the scope and nature of the interaction between the NCI and their awardees will be incorporated in the Notices of Award. It is anticipated that these terms and conditions will enhance the relationship between the National Cancer Institute and the principal investigator(s), and will facilitate the successful conduct and completion of the study. Therefore, applications falling under these guidelines, but not accepting the stated conditions, will not be considered for funding. INQUIRIES Potential applicants for research of this magnitude are strongly encouraged to contact the NCI prior to making detailed plans or submitting their application(s). Questions regarding this notice and requests for generic sample terms and conditions of award may be directed to: Director, Division of Extramural Activities National Cancer Institute Executive Plaza North, Suite 600 Bethesda, MD 20892 Telephone: (301) 496-5147 FAX: (301) 402-0956 Potential applicants will be referred for further consultation to the appropriate NCI Program and Grants Administration staff. .
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Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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