PROCEDURE

IRB Responsibilities:

An individual IRB member:

• Reads and signs a written acknowledgement annually to abide by POL009, the conflicting interest policy for IRB members, regarding required disclosure of conflicting interest when reviewing human subjects research.
• Notifies assigned OIRB staff (Director, Associate Director, or Assistant Director) prior to a scheduled convened IRB meeting if assigned to a Primary Review Team for a protocol in which there is a conflicting interest.
• Reports to the IRB Chair or senior staff member if (s)he believes another member has not disclosed a conflicting interest.
• Notifies the IRB chair at a convened meeting before being involved in the review of a protocol, an unanticipated problem involving risks to participants and others, or a report of non-compliance with the human research protection program or the requirements of the IRB (preferably at the time the meeting starts) in which the member has a conflicting interest.
• Notifies the OIRB staff if assigned as a reviewer using the expedited procedure for a protocol in which the member has a conflicting interest.
• Does not participate in any portion of the review of research activities in which (s)he has a conflicting interest except to provide information requested by the IRB and leaves the meeting during deliberation and voting.
• Absents him/herself from a meeting at any time to avoid, based on personal judgment, the appearance of a conflicting interest, or the effects of personal bias or undue influence.

The Chair (or designee):

• Calls upon members to declare any conflicting interest with items on the agenda at the beginning of the IRB meeting;
• Determines if consultants have a conflict of interest and informs them of the conflict of interest policy.

A Consultant:

• Signs a written certification that (s)he has received the conflicting interest policy and has no conflicting interest related to the human subjects research assigned for review.

Senior staff:

• Reassigns protocols to another Primary Review Team, if possible, when notified in time by a member of a conflicting interest.
• Assists in obtaining identification and disclosure of any conflicting interest and informs the Chair.
• Ensures administrative office staff record in the minutes when a member is absent from the deliberations and voting for reasons of a conflicting interest.
• Refers complex conflicts of interest to the IRB Chair for determination of conflicting interest.

Approved on March 1, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director