Human Research Protection Program: Policy

IRB Authority and Independence

Adopted By: Chancellor, UW-Madison

Adoption Date: December 8, 2005

Revised: June 7, 2007

Purpose:  This document describes the authority of UW-Madison IRBs and the process for maintaining IRB independence.

Independence of IRBs

I.   The Chancellor of the UW-Madison grants, recognizes and maintains the UW-Madison’s IRBs’ authority:

 

A.  To approve, require modifications to secure approval, and disapprove, all research activities overseen and conducted by the organization.

 

B.  To suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants.

 

C.  To observe, or have a third party observe, the consent process.

 

D.  To observe, or have a third party observe, the conduct of the research.

II.  If an IRB disapproves a protocol, defers a protocol application or requires protocol modifications as a condition for approval, no other UW-Madison official or committee may overturn the IRB’s decision nor apply undue pressure on the IRB to reverse a decision.  However, research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. 45 CFR §46 112.

III.  A protocol application that has been reviewed by a UW-Madison IRB may not be resubmitted by the investigator to another UW-Madison IRB unless the original IRB refers the protocol to the other IRB.  (See, Review by Experts Policy)

Attempts to unduly influence IRB members and IRB staff

I.   Any attempt to unduly influence IRB members and/or IRB staff in the performance of their IRB duties should be reported to the reviewing IRB chair who consults with the Institutional Official (IO) when needed.  

II.  Any attempts to unduly influence an IRB chair in the performance of his or her IRB duties should be reported to the IO. 

III.  Attempts to unduly influence IRB chairs, members, or staff will be handled by the IRB Chair and/or IO as follows:

 

A.  A prompt and thorough investigation of all allegations of attempts to unduly influence IRB chairs, members and/or staff will be conducted;

 

B.  The IRB Chair or IO will provide a written report to the Vice Chancellor for Research describing the incident, the investigation and actions taken;

 

C.  The IRB Chair or IO will take appropriate corrective action with IRB members and/or staff to ensure that their decisions are not or have not been unduly influenced; and

 

D.  Using appropriate methods, the IRB Chair or IO will communicate to IRB chair, members, staff and researchers the inappropriateness of attempts to unduly influence IRB members and/or staff in the performance of their IRB duties.