FDA issues draft guidance on electronic informed consent

FDA issued draft guidance providing recommendations for investigators, sponsors and institutional review boards on the use of electronic media to obtain and document informed consent from subjects participating in clinical trials. The document discusses use of text, graphics, audio, video, podcasts, interactive websites, card readers and biological recognition devices.

The agency permits the use of electronic signatures to document consent. According to the guidance, trial participants should have the opportunity to ask questions and receive answers prior to signing an informed consent document, as well as receive additional information regarding a trial as it progresses, whether the informed consent process takes place on the study site or remotely. ...