IRB Consultants

 

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Revised: June 7, 2007

Purpose:  This document describes the policies and procedures used by UW-Madison IRBs to obtain consultation on research protocols by independent outside experts.

Policy

I.      Each UW-Madison IRB, at its discretion and with the permission of the investigator and sponsor when appropriate, invites individuals with competence in special areas to assist in the review of complex issues that require expertise beyond or in addition to that available on the IRB.  Such special expertise may include scientific and scholarly expertise and/or knowledge about and experience working with certain vulnerable populations.  Individuals invited to consult on a research protocol may not vote with the IRB.  Confidentiality agreements are signed by consultants when appropriate.

II.     IRB consultants cannot participate in the review of any protocol in which they have a conflict of interest, as defined by the UW-Madison IRB Conflict of Interest Policy.

Procedure

III.    The IRB staff or the full IRB reviews each protocol to determine whether there is a need for additional expertise beyond that provided by the IRB members.

IV.   When additional expertise is needed, the IRB asks the investigator, and sponsor when appropriate, for permission to release confidential or proprietary information to a consultant. The IRB then contacts an individual with the needed expertise to inquire about the individual’s availability to assist in reviewing the protocol.  The IRB may use standing consultants or seek a consultant on an ad hoc basis.  The IRBs may use consultants from within or outside the UW system. 

V.    If the consultant agrees to review the protocol and has no disqualifying conflict of interest, the consultant may provide input by submitting a written report, by attending the IRB meeting, or by a phone or email consultation with the IRB director, staff or chair, who then reports the content of the conversation to the IRB. 

VI.   The IRB documents the key information provided by a consultant in its files or meeting minutes.