The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) will present a webinar on the draft guidance for industry, Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers, on Monday, 20 April 2015, from 1:00 p.m. – 2:00 p.m. EDT.

The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for regulated clinical investigations.  A copy of the guidance may be found at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Access the Webinar on Monday, 20 April 2015, from 1:00pm - 2:00pm using the following link: https://collaboration.fda.gov/guidancewebinars/

Draft FDA Guidance for Informed Consent

The U.S. Food and Drug Administration (FDA) published a new draft guidance for informed consent this July 2014.  The guidance is intended to provide information to clinical investigators, study sponsors and institutional review boards (IRBs) about the FDA's informed consent regulations.  When finalised, this guidance will supersede FDA's previous publication, "A Guide to Informed Consent" that was issued in September 1988.  

<< Click here to view the full guideline >>