Regulatory And Ethical Considerations For eConsent In Research

By Lauren Hartsmith, Director, Regulatory Affairs

In the last few years, the clinical research industry has seen a bigger push for electronic informed consent (eConsent) than ever before. Although it’s becoming more widespread, there are currently no definitions for eConsent in the Human Subjects Protection– it’s a concept only described in guidance. eConsent typically refers to the use of electronic systems and processes to:

• Convey information related to the study, and/or
• Obtain and document informed consent

These parameters are broad and vague. eConsent can include something as small as research staff collecting an eSignature via PDF, or as large as using a comprehensive eConsent platform. Essentially, if any component of your informed consent process involves an electronic aspect, you’re conducting eConsent.