Human Research Protection Program: Policy

Conflict of Interest Policy for Institutional Review Board Members and Consultants

 

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Revised: January 22, 2009

 

Purpose: This purpose of this policy is to identify, evaluate and manage conflicts of interest of Institutional Review Board (IRB) members and IRB consultants that may affect decision-making by the IRB member or consultant in the review of research protocols.  This policy places restrictions on participation in the review process by IRB members and consultants who have a conflict of interest, as defined in this policy. 

Policy

I.   A UW-Madison IRB member may not participate in the initial or continuing review of any research protocol in which the member has a conflict of interest, as defined in the policy, except to provide information at the IRB’s request. See, 45 CFR 46.107(e) and 21 CFR 56.107(e).

II.  The IRB office will provide each IRB member with guidance on the conflicts of interest policy applicable to IRB members.

III.  Any IRB member with a conflict of interest in a research protocol under review by the IRB must disclose the conflict of interest to the IRB Chair and leave the room during the discussion of the protocol and the related vote, except if the member is providing information at the IRB’s request. The meeting minutes will document the recusal (i.e., the temporary absence of the IRB member during the deliberation and vote on the protocol with respect to which the member has a conflict of interest).

IV. A member who has a conflict of interest with respect to a protocol cannot be counted for quorum when the IRB votes on that protocol.  See, IRB Composition Policy, Sec. VIII.

V.  In the case of expedited IRB review (outside of a convened meeting, by a designated reviewer), the reviewer should disclose any conflict of interest in a protocol in advance to the IRB Office and should not review the protocol.

VI. An IRB cannot use the services of a consultant in the review of a research protocol in which the consultant has a conflict of interest, as defined in this policy.

VII.Definitions

 

A.  An IRB member or IRB consultant has a conflict of interest with respect to a protocol when:

 

1.  An IRB member or IRB consultant, or an immediate family member of the IRB member or IRB consultant, has a professional interest as a principal investigator or co-investigator in the protocol, or

 

2.  An IRB member or IRB consultant, or an immediate family member of an IRB member or IRB consultant, has an interest that is related to the research and that meets or exceeds one of the following thresholds:

 

a.       Compensation of $10,000 or more in a calendar year from a business entity aggregated for the immediate family.

 

b.       An ownership interest in a publicly traded business entity valued at $10,000 or more or a 5% or greater equity interest when aggregated for the immediate family.

 

c.       Any ownership interest in a privately held business entity.

 

d.       A leadership position in a business entity (e.g. service as an officer, member of the board of directors, or in any other position of trust, confidence, and responsibility for a business entity, whether or not the investigator receives compensation for such service).

 

e.       Proprietary interest of any value including, but not limited to, a patent, trademark, copyright or licensing agreement except those managed by the Wisconsin Alumni Research Foundation (WARF).

 

3.  An IRB member or IRB consultant, or an immediate family member of an IRB member or IRB consultant, has a personal relationship that may cause bias or create the appearance of bias by the member or consultant in the review of the protocol.

 

B.  A principal investigator is responsible for the planning, design, or publication of research.

 

C.  A co-investigator shares at least some of these responsibilities with a principal investigator.

 

D.  An “immediate family member” includes spouse and dependent children.

Procedure

VIII.IRB Members

 

A.  The IRB office will annually provide each IRB member with the IRB Member and Consultant Conflict of Interest Policy and will remind members at the time of protocol assignments and at the time of IRB meetings of the need to disclose conflicts of interest with individual protocols being reviewed.

 

B.  Before the IRB office assigns protocols for review, it will make an initial assessment whether there is a conflict of interest on the part of an IRB member.

 

C.  A designated IRB reviewer performing expedited review of protocols has the responsibility to review the list of protocols and disclose any potential conflict of interest in advance of the review to the IRB office.  The IRB office will reassign any protocol with which an expedited reviewer has a conflict of interest.

 

D.  When IRB members receive materials before a meeting, they have a responsibility to review the list of protocols for initial or continuing review with the issue of conflicts of interest mind and disclose any potential issue to the IRB office or IRB chair in advance of the meeting when possible.  Early disclosure permits the IRB office to assure a quorum for review and the IRB chair to excuse the member from any final discussion of, and voting on, the protocol.

IX. IRB Consultants

 

A.  Before the IRB office assigns protocols to an IRB consultant for review, it makes an initial assessment whether there is a conflict of interest on the part of an IRB consultant.

 

B.  When requesting a consultant to review a protocol, the IRB office will provide each IRB consultant with guidance on the conflicts of interest policy applicable to IRB consultants.

 

C.  Upon receipt of a request to provide consultation to the IRB, IRB consultants have the responsibility to determine whether they have a conflict of interest with a protocol they are asked to review and should notify the IRB office immediately if there is a potential conflict of interest with respect to the protocol.

 

D.  When appropriate, the IRB office asks the investigator’s permission to share the protocol with the consultant to ensure there is no perception of conflict of interest.

 

E.  The IRB office will reassign any protocol with which a consultant has a conflict of interest.