Human Research Protection Program: Policy

Monitoring the Consent Process

Adopted By: All Campus IRB

Adoption Date: November 10, 2005

Purpose:  This document describes when and how a UW-Madison IRB may arrange for the informed consent process in research to be observed.

Policy

I.      UW-Madison IRBs may require observation of the consent process and the signing of consent forms, when appropriate, to assure that investigators satisfy all federal, state and institutional requirements for obtaining informed consent from participants in human subjects research.

II.     Observation of the consent process will be required only if the IRB concludes that no other alternative action will adequately protect prospective participants in the informed consent process.

III.    Factors that may cause UW-Madison IRBs to consider monitoring of the consent process include, but are not limited to, particular vulnerabilities of prospective participants, complexity of the research, investigator conflicts of interest, prior complaints about the consent process or prior findings of noncompliance.

IV.   If a UW-Madison IRB determines that monitoring of the consent process is appropriate, the IRB may designate one or more of the following as a monitor:

A.  an IRB member or members

B.  a member or members of the IRB staff  

C.  another individual(s) in the organization who is not part of the research team (e.g., the General Clinical Research Center’s (GCRC) Research Subject Advocate), or  

D.  a neutral, uninvolved third party hired by the organization, investigator, or sponsor.

V.    UW-Madison’s Research Policy Office (RPO) may also monitor the consent process in research as part of it periodic audit of research activities. For more information, see, Internal Audit of HRPP.

Procedure

VI.   The decision whether to require monitoring of the informed consent process will be made by the IRB after a thorough review of:

A.  the research protocol and IRB application, including the subject population and the complexity of the research

B.  the proposed consent process as described by the investigator

C.  the consent documents

D.  the qualifications and role of each individual who will be involved in the consent process

E.  all alternative actions that are available to assure protection of participants in the informed consent process.