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PUBLICATION: Digitizing Consent:...

FDAThe U.S. Food and Drug Administration (FDA) has issued draft guidance on the use of "electronic informed consent" (eIC) in FDA-regulated clinical trials of medical products, including drugs and biological products, medical devices, and combinations of those products for human use. As part of an effort to harmonize agencies' regulations and guidance for human subjects research, the federal Office for Human Research Protections (OHRP) is considering a joint FDA-OHRP final guidance document. Both the FDA and OHRP solicited public comments about the proposed guidance. In this article, we describe the context for the emergence of the FDA's draft guidance, describe its key components, and as empirical researchers of electronic consent processes, discuss implications for intended stakeholders.

For a copy of the abstract, please click here. The full text of the article is not available at this time.

Simon CM, Klein DW, Schartz HA. Digitizing consent: The Food and Drug Administration's draft guidance on electronic informed consent. IRB: Ethics & Human Research. 2016; 38: 15-18.

Wednesday, September 28, 2016