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FDA and HHS Announce Guidance on Electronic Informed Consent (US)
Practical Law Legal Update w-005-2386 (Approx. 2 pages)
FDA and HHS Announce Guidance on Electronic Informed Consent (US)
by Practical Law Life Sciences
| Published on 03 Jan 2017 • USA (National/Federal) |
The FDA and the Department of Health and Human Services announced final guidance on electronic informed consent for research involving human subjects.
On December 15, 2016, the FDA and the Department of Health and Human Services (HHS) announced final guidance entitled Use of Electronic Informed Consent—Questions and Answers, which finalizes draft guidance from March 2015. The guidance provides recommendations on electronic systems and processes to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations. It is written in a question-and-answer format and was developed as part of the agencies' efforts to harmonize requirements and guidance for human subject research.
The guidance provides recommendations on:
- Facilitating the study subject's comprehension of the information presented during the electronic informed consent process.
- Ensuring that appropriate documentation of consent is obtained, especially when using different forms of electronic media.
- Preserving the quality and integrity of electronic informed consent data for FDA submissions and inspections.
Comments on this guidance can be submitted at any time.