New Guidance on Electronic Informed Consent

The federal government recently issued new guidance on the use of electronic systems and processes to obtain informed consent from subjects involved in FDA-regulated research and clinical trials. The document clarifies how electronic tools, such as podcasts and interactive web sites, can be used to convey information to potential study participants and included in applications for new drugs and devices.

“Use of Electronic Informed Consent (eIC): Questions and Answers,” issued jointly by the FDA, part of the Department of Health and Human Services (HHS), and the Office for Human Research Protections (OHRP), is intended for use by Institutional Review Boards (IRB), investigators, and trial sponsors. Topics include how to verify electronic signatures, ensure privacy and security, and assess participants' comprehension of the materials.

“The research community is showing increasing interest in using electronic media to supplement or replace paper-based informed consent processes,” says Leonard Sacks, MD, associate director for Clinical Methodology in the FDA's Center for Drug Evaluation and Research. “The FDA and OHRP published this joint final guidance to answer commonly asked questions about using eIC for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products.”

According to the document, investigators must have methods in place to ensure that subjects understand the material and are able to ask questions, whether the eIC process takes place on site or remotely. For example, investigators should be available for discussions either in person or via electronic messaging, phone calls, video conferencing, or live chat.

Before presenting eIC materials to potential participants, the document advises investigators to discuss their plans with their institution's IRB, which requires copies of all electronic forms and presentations as part of its review process. Investigators are not specifically required to submit informed consent documents with new drug applications, but regulators may request them, particularly in cases where a drug is associated with high toxicity or if a study poses serious potential risks to participants.

Although it may not be appropriate for all subjects, electronic media has the potential to significantly improve the informed consent process, notes Sacks. For example, interactive interfaces can be more effective than paper-based forms in helping people retain and understand complex information.

In addition, “these electronic processes may allow for rapid notification of any amendments pertaining to the informed consent that may affect subjects' willingness to continue to participate,” he says. “They may also promote timely entry of any eIC data into a study database and allow for timely collection of data from remote locations.” –Janet Colwell