April 16, 2015
New guidance issued by the FDA could make it easier for companies to conduct clinical trials by explaining how federal regulators will permit companies to use electronic media such as interactive websites to help facilitate the informed consent process. 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 FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices and combinations thereof. According to the FDA, as long as the information provided is “adequate” and “understandable”, using a variety of methods to convey informed consent should be acceptable.
This guidance document is open for public consultation until 60 days after its publication on March 3, 2015.