FDA, OHRP Seek Comment on Proposed Guidance on Electronic Consent

The Food and Drug Administration (FDA) has released draft guidance on using electronic media and processes to obtain informed consent in FDA-regulated clinical investigations. The guidance covers how and when electronic informed consent information should be presented, how to ensure subjects’ understanding of the information, how to maintain confidentiality and security, and how to keep appropriate documentation of the consent process.

FDA is seeking public comment on the draft guidance by May 8, 2015. Instructions and more information are in in the Federal Register notice.

The Office of Human Research Protections (OHRP) is soliciting comments on whether the FDA’s draft guidance is appropriate for research under the Office’s purview (regulated under 45 CFR 46). As part of an effort to harmonize agencies’ regulations and guidance for human subjects research, OHRP is considering issuing the final guidance as a joint FDA-OHRP document. The Office will consider comments received from the public in its decision making.

Comments to OHRP are also due on May 8, 2015. More information and instructions are available in a separate Federal Register notice.

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Posted in Issue 4 (March 13), Update, Volume 34 (2015)


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