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University of Pittsburgh

Activities and Services

Informed Consent Process

The informed consent process is the keystone of ethically conducted human subject research. The University of Pittsburgh IRB has the authority to direct the ECO-HSR to monitor/observe the informed consent process for any protocol under its jurisdiction. This authority is outlined in 45 CFR 46.109(e) which states:

  • "An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research. "

The ECO-HSR staff conducts audits of the informed consent process at the request of the IRB.