Key Takeaways from the FDA-HHS eConsent Guidance
January 20th, 2017 by Danielle Macario, PhD, CIP, IRB Member at Schulman IRB and Stephanie Pyle, MFA, Manager of Community and Communication at Schulman IRB
In December 2016, FDA released its guidance on the use of eConsent in clinical research. Jointly prepared by HHS and FDA, the document provides IRBs, investigators and sponsors with recommendations on using electronic systems and processes to obtain consent in HHS-regulated and FDA-regulated clinical trials.
Presented in a Q&A format, the guidance addresses the creation and review of eConsent materials. It also provides many options in the execution of electronic informed consent, which allows for flexibility across many different study designs.
eConsent has been on the research community’s radar for several years as a way to improve the informed consent process for study participants and researchers alike. This, however, is the agencies’ first official guidance on the topic. Here are some key takeaways from the guidance:
The same requirements that apply to paper informed consent documents apply to the electronic informed consents. This includes the requirement that subjects receive a copy of the consent document. A significant benefit of eConsent is its ability to use different types of media (e.g., graphics, video, audio clips, etc.) to present study information, which can help potential participants better understand complicated concepts. Keep in mind, however, that an eConsent must still present the required elements of informed consent.
FDA and HHS expect eConsent technology to comply with FDA regulations for electronic records and electronic signatures. Following the regulations defined under 21 CFR part 11 will help ensure that the electronic records and signatures that are applied to electronic records are trustworthy, reliable, and generally equivalent to a handwritten signature executed on paper.
An IRB must review and approve all elements of the eConsent before it is implemented. The investigator should submit to the IRB copies of all forms (electronic and paper forms) and supporting materials (i.e. videos or Web-based presentations) which will be subject-facing during the consent process.
HIPAA authorizations may be obtained electronically when using eConsent. This is provided that the subject’s signature is a valid electronic signature under applicable laws and regulations. The HIPAA Privacy Rule requirement for providing the authorizing individual with a copy of the signed authorization document also applies when the HIPAA authorization is obtained electronically.
eConsent procedures should ensure materials are appropriately archived and easily retrievable. The procedures must comply with applicable FDA regulations for electronic records. Note that the regulations don’t identify specific procedures sponsors and sites should use for archival and retrieval.
These are just the highlights; the guidance provides even more useful information, and the Q&A format makes it a pretty easy read. If you are considering eConsent for your next study, be sure to familiarize yourself with this information. The team at Schulman IRB is also available to assist with any questions.