March 13, 2015
On March 9, 2015, the Food and Drug Administration (FDA) announced in the Federal Register (FR) the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards 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 Office for Human Research Protections (OHRP) in the same issue of the FR published a notice requesting public comment on whether FDA’s draft guidance document would be appropriate for all research regulated under 45 CFR part 46.
The OHRP and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research, and the FDA draft guidance document was developed as a part of these efforts. Although this document is issued by FDA and is drafted as guidance that would apply to FDA-regulated clinical investigations, 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. OHRP will consider comments received from the public before deciding whether to issue a joint final guidance document with the FDA.
OHRP’s FR Notice with instructions on how to submit comments to OHRP can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2015-03-09/pdf/2015-05301.pdf. Comments are due by May 7, 2015.
FDA's FR Notice with instructions on how to submit comments to FDA can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2015-03-09/pdf/2015-05377.pdf. Comments are due by May 7, 2015.
FDA's Draft Guidance document can be accessed at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf.
