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Digitizing Consent: The Food and Drug Administration’s Draft Guidance on Electronic Informed Consent

In March 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance specific to the use of electronic informed consent (eIC) in FDA-regulated clinical investigations. In an effort to harmonize agencies’ regulations and guidance for informed consent in human subjects research, the Office for Human Research Protections (OHRP) solicited public comment on whether to adopt the FDA guidance for regulation of human subjects research under their purview and issue a joint FDA-OHRP final guidance document. Thus, the guidelines would be applied relevant to FDA clinical investigations (subject to 21 CFR parts 50 and 56) as well as all human subjects research under 45 CFR part 46, including social and behavioral research studies. This commentary examines the context of the proposed guidance, describes its key components, and discusses some of the implications for intended stakeholders.

Keywords: electronic informed consent, regulation of human subjects research, U.S. Food and Drug Administration, Office for Human Research Protections, FDA guidance for regulation of human subjects research