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116.4 Organization Policy on IRB Review of Federal-Approved Consent Documents for Federally-Supported Multicenter Clinical Trials

May 2005

It is the policy of the organization that each IRB will receive and review a copy of the Federal agency approved sample informed consent document and the agency approved protocol as a part of the review process, when applicable. Any deletion or substantive modification of consent information concerning risks or alternative procedures contained in the sample informed consent document must be justified in writing by the investigator, approved by the IRB, and reflected in the IRB minutes.