March 12, 2015

FDA Issues Draft Guidance on “Use of Electronic Informed Consent in Clinical Investigations”

FDA recently issued draft guidance on “Use of Electronic Informed Consent in Clinical Investigations.” The guidance document is now available on FDA’s web site: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf

This 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 FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.

The FR Notice with instructions on how to submit comments can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2015-03-09/pdf/2015-05377.pdf.

Comments are due by May 8, 2015.