Electronic Informed Consent Gets More Guidance from FDA
​[Posted on: Thursday, December 15, 2016]

Last year FDA released a Guidance Document regarding use of electronic informed consent in clinical trials. The use of electronic informed consent adds practical and logistical challenges to the informed consent process despite the obvious benefits. This week, FDA published additional guidance on a Q&A format seemingly to address the key concerns raised by users. The key process of informed consent does not change when electronic ICF is used compared to paper version. The subjects needs to be given sufficient time to review the ICF, provided answers to all questions, and given access to all relevant information. However, there are a few practical considerations, since it is expected that the subject may review the eICF remotely, it is important to add measures to confirm identity of the subject giving consent. FDA suggests using any government issued identification for this purpose. This is different from the paper version, where usually IDs are not verified. The subject also must complete the eICF at the site, and the signatures must be witnessed. Electronic signatures are allowed, but for subjects who are unable to or prefer paper version, the site should provide paper copies. Similarly for giving copies of the signed ICF to the subjects, site can either provide the paper copy of the signed ICF, or provide the same electronically, either on a media format or by email. Since eICF usually contain electronic elements such as hyperlinks, videos, and other media to assist understanding, all these must be included in the copy provided to the subjects. Overall, it seems eICF raises more work compared to the benefit offered. Maybe this is the reason why eICF used rarely; most trials still prefer the paper ICF. Sponsors can always provide the electronic version of the informed consent information in addition to the paper version to help subjects but when it comes to informed consent, paper still rules.