by Claire Carbary

Regulatory Update: Draft FDA Guidance on eConsent in Clinical Trials

On March 6, 2015, the FDA issued draft guidance on the “Use of Electronic Informed Consent in Clinical Investigations.” The guidance is in a Q&A format and provides some helpful insights into FDA’s thinking about the use of electronic informed consent in FDA-regulated research. The FDA defines electronic informed consent as use of “electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive websites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.”

The draft guidance addresses these major points:

  • The logistics of obtaining electronic consent and returning the consent documents and other related information to subjects
  • Technical requirements for electronic consent systems
  • Documentation that should be submitted to FDA or retained in relation to the electronic consent process

The FDA takes a high-level approach with this draft guidance, providing a framework for considering the various issues raised by electronic informed consent. So far, the research industry has approached electronic consent with caution, however, there seems to be widespread agreement that this approach will eventually replace the paper-based process. This guidance will be helpful as organizations consider implementing electronic consent on a wider basis.

This guidance is in line with Quorum Review’s current process and policies for reviewing eConsent; however, some of the recommendations will allow Quorum to further streamline its submission process and set clearer expectations for organizations hoping to use electronic consent. If you’d like to learn more about Quorum’s process for reviewing eConsent, download our Client guidance.

Read Jim Gearhart’s blog post, an interesting look at the consent processes of the recent ResearchKit studies against the FDA’s draft guidance.

 

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