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

April 2016

It is the policy of the Organization that for federally-funded multicenter clinical trials, the JHM IRBs will review the protocol and the sample informed consent document(s) approved by the funding agency, when applicable. Any deletion or substantive modification of information concerning risks or alternative procedures contained in the sample informed consent document(s) must be justified in writing by the Principal Investigator, approved by the IRB, and documented in the IRB’s meeting minutes.