VCOM Institutional Policy and Procedure Manual

administrative fee for continuing review will be assessed annually for the duration of the trial. Amendments requiring full board review will also be charged an administrative fee of $700. Industry sponsored trials are defined as those supported by pharmaceutical firms and other for-profit entities. The administrative fee for initial review for expedited protocols sponsored by industry is $750 and an administrative fee of $500 will be assessed for each continuation review for the duration of the trial. Expedited review of amendments is $500. Amendments or continuation reviews that fall under the expedited category for full board initial reviews will be charged an administrative fee of $500. Industry-sponsored trials that are deemed exempt by the VCOM IRB will be charged $400. 2.2 Federal, Foundation, Investigator-Initiated & University-Supported Research The administrative fee for initial, full board review of a trial sponsored by the federal government, a non-profit foundation or a University or College, as well as any non-funded trial, is $750, and a $500 administrative fee for continuing review will be assessed annually for the duration of the trial. Amendments requiring full board review will also be charged an administrative fee of $500. Industry sponsored trials are defined as those supported by pharmaceutical firms and other for-profit entities. The administrative fee for initial review for expedited protocols sponsored by the federal government, any nonprofit foundation or a University or College, as well as any non-funded trial, is $400 and an administrative fee of $200 will be assessed for each continuation review for the duration of the trial. Expedited review of amendments is $200. Amendments or continuation reviews that fall under the expedited category for full board initial reviews will be charged $200. Trials that are deemed exempt by the VCOM IRB will be charged an administrative fee of $50. For research involving students, interns or residents not affiliated with VCOM and whose research does not have external or internal funding, discounts may be available. Additionally, there will be no administrative fee for continuing review of these protocols. P AYMENT OF A DMINISTRATIVE F EES All Non-VCOM Investigators submitting industry-sponsored research protocols to the VCOM IRB are required to include a separate line item in the study budget for initial and continuing IRB review. Indirect costs should not be applied to these administrative fees. Payment will be due thirty (30) days from receipt by the IRB Coordinator. Administrative fees for continuing review will be charged annually until a Final Report form is submitted to the IRB Coordinator. IRB administrative fees should be written into the budgets of federal, foundation and University/College sponsored protocols if allowable. Payment of administrative fees is regarded as a contractual responsibility of the sponsor. Because the IRB commits resources to each review, the administrative fees are due in full from the sponsor, even if the IRB does not approve the study, subjects are never enrolled or the study is terminated before objectives are reached. Exemptions will be considered for extenuating circumstances. A request for 3.