The feds weigh in on electronic consent
It’s becoming increasingly rare for us to transmit large chunks of information via pages and pages of printed text. One notable exception is the documenting of informed consent for research. While the research community continues to explore ways to make informed consent forms and processes easier for subjects to understand, relatively long and complex research consent forms remain the norm.
However, thanks to technology, we can think more broadly about obtaining and documenting informed consent. We can have live discussions with people who aren’t in the room with us, and get their electronic signature on a consent form relayed to them electronically.
The Food and Drug Administration and the Office for Human Research Protections have issued a new Q&A guidance titled “Use of Electronic Informed Consent.” We love this guidance for several reasons. First, it recognizes that obtaining informed consent electronically is becoming a real thing in research. Secondly, it documents that these two federal agencies, whose regulations and requirements differ from each other, are trying to give us some ideas about obtaining consent through electronic means acceptable to both of these agencies. Third, it highlights how electronic consent processes can meet all the current requirements for consent. Those requirements don’t spell out HOW consent must be obtained. Instead, they indicate what must be covered in the consent discussion and how that discussion should be documented. It says nothing about electronic versus paper, leaving open both methods as viable ways to get consent.
IRB reviewers, note that guidance question 13 specifically addresses the IRB’s responsibilities in the review of electronic consent processes.
We strongly encourage researchers, study teams, and IRB reviewers and staff to become familiar with this new guidance.