FDA Allows for Electronic Informed Consent, Provides Guidelines for Meeting Regulatory Requirements

By Josephine M. Torrente & James E. Valentine* – 

On March 9, 2015, FDA announced the availability of draft guidance which allows the use of electronic informed consent (“electronic IC”) in FDA-regulated clinical investigations of medical products (and the use of electronic assent in pediatric studies).  Electronic IC can employ one or more forms of electronic media, including “text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers.”  In addition, electronic IC may use interactive computer-based technology, such as “diagrams, images, graphics, video technology and narration,” which may include questions at the end of each section to assess the subject’s understanding.  These electronic IC materials can be used either at the clinical investigator’s site or remotely.  This effort harmonizes FDA regulatory requirements with Health and Human Services’ Office of Human Research Protections (see, e.g., OHRP policy allowing electronic signatures to document informed consent).

This guidance comes in response to the clinical research community’s interest in using electronic media to provide information usually contained within the informed consent document, evaluating the subject’s comprehension of the information presented, and documenting the consent of the subject.  Research studies are growing in complexity and duration, which leads to informed consent documents that are increasingly long and more difficult to understand.  Electronic IC may be helpful in providing subjects with information about study procedures in a way that is easy to understand and is communicated in a standardized way—and could even better assess and document comprehension. 

Additionally, electronic IC may allow for rapid notification of amendments pertaining to the informed consent that may affect a subject’s willingness to continue to participate, as well as promote timely entry of documentation of informed consent. 

The draft guidance expands on FDA’s regulations that state “informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject…at the time of consent” (21 C.F.R. 50.27(a)). FDA explains that informed consent is “mistakenly viewed as synonymous with obtaining a hand-written signature” and explains that there can be electronic documentation of informed consent as well.   Still, electronic IC must comply with FDA requirements for electronic records/electronic signatures, informed consent, and institutional review boards (“IRBs”) which are set forth in 21 C.F.R. Parts 11, 50, and 56, respectively.  Many of these requirements are reiterated in the draft guidance (e.g., requisite elements of informed consent, providing the subject a copy of the informed consent, IRB review, recordkeeping). 

The draft guidance lays out a number of key considerations for utilizing electronic IC, including:

• ensuring interactive electronic IC programs are easy to navigate and appropriate for the intended audience, taking into account age, language, and comprehension level;
• if remote, obtaining documentation to ensure responses cannot be altered and ensuring the person signing the informed consent is the subject;
• if remote, providing an opportunity to ask questions and receive answers prior to signing the electronic IC, as well as throughout the trial (which can be done using electronic messaging, telephone calls, videoconferencing, or a live chat);
• ensuring the transmission of significant new findings to the subjects;
• considering whether to use a method of obtaining electronic signatures;
• providing a signed consent form with date stamp to subjects (e.g., by email)
• disclosing risks of electronic transmission (e.g., e-copy could be hacked from email or personal electronic device, e-copies delivered by email may not be able to be permanently deleted);
• protecting confidentiality through use of restricted access computerized systems; and
• including procedures to ensure archival of electronic documents and all versions of the electronic IC, as well as having an audit trail capability to capture details of changes.

The specifics of any individual electronic IC are left to the review by an IRB.  FDA recommends investigators discuss plans with the IRB prior to finalizing the development of the electronic IC to ensure the IRB agrees with providing informed consent in an electronic format.  

Comments on the FDA Draft Guidance can be submitted to FDA until May 7, 2015, here.

*Admitted only in Maryland. Work supervised by the Firm while D.C. application pending.