This document describes the policies and procedures used by UW-Madison IRBs to obtain consultation on research studies by independent outside experts.
- UW-Madison IRBs use three types of consultants: IRB Member Consultants, Ex-Officio (non-voting) Consultants, and External (non-voting) Consultants.
- IRB Member Consultants are IRB members who may be asked by the IRB chair or staff to consult on a particular submission (e.g., an expedited change, reportable event) that he or she is not assigned to review.
- Per the IRB Member Conflict of Interest Policy, IRB members who act as consultants for a submission reviewed by the IRB to which they were appointed may participate in a discussion of and vote on a study they have provided a consultation for if they do not otherwise have a potential conflict of interest related to the study under consideration and they are the IRB member scheduled to attend that meeting.
- Ex-officio Consultants are individuals who by virtue of their positions may be asked by the IRB to provide their assessment of a study.
- This group of consultants includes members of a non-reviewing UW-Madison IRB, the Human Research Protection Program Manager, as well as legal counsels, privacy officers, security officers, and other compliance officials of the UW and its affiliated institutions.
- External Consultants are individuals outside of the first two categories of consultants, who may be invited to assess a study or component of a study because of their competence in special areas, especially in the case of complex or unusual 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.
- Confidentiality agreements are signed by consultants when appropriate.
- The IRB Chair, IRB staff, or the convened IRB reviews each study to determine whether there is a need for additional expertise beyond that provided by the IRB members or ex officio consultants.
- When the expertise of an external consultant is needed, the IRB asks, when appropriate, the investigator and sponsor, for permission to release confidential or proprietary information to a consultant.
- Such permission is not sought when the consultant is an IRB member or an ex officio consultant.
- The IRB may use standing consultants or seek a consultant on an ad hoc basis.
- IRB consultants cannot participate in the review of any study in which they have a conflict of interest, as defined in the UW-Madison Institutional Review Board Members Conflict of Interest Policy.
- The IRB office is responsible for making the initial assessment in regard to whether there is a conflict of interest on the part of an IRB consultant, confirms with the consultant that no conflict of interest exists, and documents this confirmation.
- The IRB office asks consultants if they have a conflict of interest with the study and consultants must confirm that they do not have a conflict of interest per the UW-Madison Institutional Review Board Members Conflict of Interest Policy before the IRB relies on the review.
- If an external consultant agrees to review the study and has no disqualifying conflict of interest, the consultant may be invited to attend, either in person or by telephone conference call, an IRB meeting at which the study is reviewed, for the purpose of presenting his/her review and answering IRB members’ questions. The consultant also may provide a written review of the study or an oral review that will be transcribed by an IRB staff member and provided to IRB members.
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: June 7, 2007
Revised: November 5, 2009
Revised: December 3, 2009
Revised: March 1, 2012
Revised By: Cross Campus Human Research Protection Program Advisory (HRPP) Advisory Committee
Revision Date: July 7, 2015
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