Guidance on Electronic Informed Consent has Shortcomings: Analysis


McDermott was cited for the Firm’s analysis of the FDA’s draft guidance on Use of Electronic Informed Consent (eIC) in Clinical Investigations. The McDermott analysis said the FDA’s guidance fails to address key questions that may arise during eIC implementation, but added that the guidance still supports researchers’ and sponsors’ interest in harnessing technology to ease administrative burdens and better inform subjects about potential risks and benefits.