VCOM Institutional Policy and Procedure Manual

Edward Via College of Osteopathic Medicine

Policy Order No.: R004A4 Effective Date: April 1, 2007

Signature on File ____________________________ Dixie Tooke-Rawlins, D.O. Dean and Executive Vice President

Signature on File ____________________________ James F. Wolfe, Ph.D. President ___________________________________________________________________________________________ Addendum to VCOM IRB Policy No. R004 VCOM Policy on IRB Administrative Fees for Protocol Review ____________________________________________________________________________________ P URPOSE The purpose of this policy is to define the College’s guidelines regarding Institutional Review Board administrative fees charged to all Non-VCOM Investigators . A Non-VCOM Investigator is an individual who is not : 1. The volume and complexity of research conducted at the Virginia College of Osteopathic Medicine (VCOM) and other institutions utilizing VCOM’s IRB has dramatically increased in the past year. As a consequence the VCOM IRB has experienced a continual increase in new protocol submissions that has necessitated expansion of IRB staff and services. In the past, the IRB has absorbed the costs associated with administration of initial and continuing protocol review; however, the IRB is no longer able to fully absorb these administrative costs and must institute changes to off-set the additional administrative costs associated with expansion. Effective July 15, 2007 the IRB will charge an administrative fee for all submissions requiring full board or expedited review from all non-VCOM investigators. A DMINISTRATIVE F EE B REAKDOWN Administrative fees will be charged on protocol submissions from any investigator who is not a VCOM faculty member, a VCOM student or a Virginia Tech employee holding a joint appointment at VCOM. 2.1 Industrial-Sponsored Protocols The administrative fee for initial, full board review of an industry-sponsored protocol is $1,500, and a $700 2. 1. Employed by VCOM, 2. A VCOM Student or 3. A Virginia Tech employee holding a joint-appointment with VCOM.