VCOM Institutional Policy and Procedure Manual

Edward Via College of Osteopathic Medicine

Policy Order No.: R004A3 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 Member Conflict of Interest ____________________________________________________________________________________ P URPOSE It is the expectation of the College that IRB members will voluntarily recuse themselves from review, discussion and vote of research protocols if they have a conflict of interest. Members of the IRB must disclose to the IRB Chair or Coordinator any conflict of interest that may 1.

arise in the review of research or compliance matters for the IRB. A risk of non-recusal is a compromised objectivity. This includes:  Biased opinion of the merit of the study.  Biased opinion of whether IRB criteria for approval have been met.  Undue influence on other IRB members.  Appearance of impropriety; loss of public trust.

2. R ECUSAL FROM D ISCUSSION 2.1 Conflicts of Interest that Require Member Recusal Members who are an investigator or faculty sponsor on the project under review, or whose spouse or child is an investigator or faculty sponsor must recuse themselves from discussion. Members who have any financial interests that would reasonably appear to be affected by the research or who have financial interests in entities whose financial interests would reasonably appear to be affected by the research must recuse themselves. Members who believe existing circumstances may directly affect their objectivity should recuse themselves from the review.