VCOM Institutional Policy and Procedure Manual

2.2 Financial Interests that Require Recusal from IRB Review Ownership interest, stock, stock options or other financial interest related to the research are reasons for recusal. Compensation related to the research including salary, consultant payments, honoraria, royalty payments, dividends, loans and other payments/considerations of value are financial conflicts of interest.

2.3 Other Circumstances for Recusal from IRB Review

 A member is involved in a potentially competing research program.  A member has access to funding or intellectual information that may create an unfair competitive advantage.  A member’s personal biases may interfere with his or her impartial judgment. 2.4 What to Do if You Have a Conflict of Interest Inform the IRB Chair or Administrator as soon as possible. Recuse yourself from any discussion of the protocol. Please do not discuss details of the conflict of interest. All recusals are recorded in the IRB meeting minutes.

3. B ACKGROUND & R EGULATIONS DHHS and FDA regulations [45CFR 46.107(e) & 21 CFR.56.107(e)] prohibit members from participating in IRB reviews if they have a conflict of interest:

No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

4. D URATION OF P OLICY The VCOM Policy on IRB Member Conflict of Interest established by the Institutional Review Board is effective as of the date above and shall remain effective until amended or terminated by the President and the Dean.

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