New Final Guidance From the FDA on Electronic Informed Consent

Final guidance was published on December 15 by the U.S. Food and Drug Administration (FDA) with frequently asked questions and answers regarding the use of electronic informed consent vehicles. This is the final guidance from the draft guidance released in March 2015.

“Use of Electronic Informed Consent: Questions and Answers” provides guidelines on how an electronic informed consent process should be executed, from presenting it to a patient to information security during the process. The FDA defines electronic informed consent within this guidance as “electronic systems and processes,” which includes text, graphics, audio, video, podcasts, and passive and interactive Web sites.

Informed consent, a required process for clinical trials, provides participants with the information required to make an informed decision regarding their participation in a clinical study. The process is not just about giving a participant clinical information; it allows the participant time to ask questions and consider options before enrolling in a study. Informed consent continues throughout the duration of a study, as the study or patient situation may change.

If you have any questions about the FDA guidance, please contact the MHRI Office of Research Integrity at MHRI-ORIHelpDesk@MedStar.net.