Today the Food and Drug Administration (FDA) published a notice announcing the availability of a draft guidance document entitled “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” The draft guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain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. The guidance provides recommendations on procedures that may be followed when using an electronic informed consent (eIC) to help:
- ensure protection of the rights, safety, and welfare of human subjects
- ensure the subject's comprehension of the information presented during the eIC 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 eIC data included in FDA application submissions or made available to FDA during inspections
FDA is requesting comments on the draft guidance; to be assured of consideration during development of the final version, submit comments by May 8, 2015. Note that while the document is issued by FDA and is drafted as guidance that would apply to FDA-regulated clinical investigations, the HHS Office for Human Research Protections (OHRP) is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations, 45 CFR part 46, and to issue a joint OHRP and FDA guidance document on this topic when the final guidance document is developed.