eClinical Technology and Industy News

The Proposed New FDA Rule Brings Changes To Informed Consent for Clinical Studies

The Diagnostic and Interventional Cardiology website posted an important article about recent proposed changes by the FDA which may allow Institutional Review Boards (IRB) to waive or alter informed consent requirements for clinical studies that pose minimal risk to human participants. The conditions under which an IRB could do this are limited and detailed in the proposed new rule.

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