Ancillary Studies in Clinical Trials (R01)

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Purpose. The purpose of this Funding Opportunity Announcement (FOA) is to solicit research grant applications to conduct time-sensitive ancillary studies related to heart, lung, and blood diseases and sleep disorders in conjunction with ongoing clinical trials and other large clinical studies supported by NIH or non-NIH entities. The program establishes an accelerated review/award process to support the crucial time frame in which these ancillary studies must be performed. Time-sensitive ancillary studies include those that require active longitudinal data collection and thus need to begin recruiting subjects as close as possible to the start of the parent study. The ancillary study can address any research questions related to the mission of NHLBI for which the parent study can provide participants, infrastructure, and data. The parent studies most often will be a clinical trial, but also can be an observational study or registry that can provide a sufficient cohort of well-characterized patients. Each ancillary study application must demonstrate the time-sensitive nature of the proposal and must explicitly address why an expedited review is essential to its feasibility. Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) grant mechanism. Funds Available and Anticipated Number of Awards. NHLBI intends to commit approximately $4.8 million in FY 2011 to fund up to 12 new grants under this FOA. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. Budget and Project Period. An applicant may request a project period of up to 4 years and a budget for direct costs up to $250,000 (10 modules) per year, excluding subcontractor or consortium indirect costs.

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