Electronic Informed Consent Guidance Issued
Friday, March 20, 2015
The FDA announced the availability of a draft guidance, “Use of Electronic Informed Consent in Clinical Investigations," which allows the use of electronic informed consent (“electronic IC”) in FDA-regulated clinical investigations of medical products (and the use of electronic assent in pediatric studies). Electronic IC can employ one or more forms of electronic media, including “text, graphics, audio, video, podcasts, and interactive Web sites, biological recognition devices, and card readers.” In addition, electronic IC may use interactive computer-based technology, such as “diagrams, images, graphics, video technology, and narration,” which may include questions at the end of each section to assess the subject’s understanding. These electronic IC materials can be used either at the clinical investigator’s site or remotely.
This guidance comes in response to the clinical research community’s interest in using electronic media to provide information usually contained within the informed consent document, evaluating the subject’s comprehension of the information presented, and documenting the consent of the subject.
This guidance provides recommendations on procedures that may be followed when using an IC to help:
- Ensure protection of the rights, safety, and welfare of human subjects
- Ensure the subject’s comprehension of the information presented during the IC process
- Ensure that appropriate documentation of consent is obtained when electronic media and processes are used to obtain informed consent
- Ensure the quality and integrity of IC data included in FDA applications and made available to FDA during inspections
Comments and suggestions regarding this draft document should be submitted by May 8, 2015. Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified Docket No. FDA-2015-D-0390.