FDA, OHRP Publishes Joint Guidance on Electronic Informed Consent
The FDA and the HHS Office of Human Research Protections published a joint guidance on the use of electronic informed consent, containing recommendations for meeting both agencies’ regulations. The guidance — presented in a question-and-answer format for sponsors, researchers and institutional review boards — finalizes a draft published in March 2015, with minor changes.
Information can be presented to the patient electronically through multiple media, including text, graphics, audio, video, podcasts and interactive websites, the guidance said. The information must contain all the informed consent elements required by HHS and the FDA. It should be easy to navigate or pause, and allow enough time for the subject to consider whether to participate. Subjects should also receive a copy of their consent agreement.
Investigational device exemption applications must include copies of all forms and informational materials to be provided to subjects to obtain informed consent. When FDA approval of an IDE application is required, a sponsor must not begin an investigation until that approval is given.
The full guidance is available here: www.fdanews.com/12-14-16-FDAOHRPeConsentGuidance.pdf. — Conor Hale