Re-Consent In Clinical Trials: Streamlining With eConsent

By Tina Caruana, eClinical Solutions Subject Matter Expert; Melissa Newara, VP of Subject Matter Expertise; and Rebecca Jones, Product Marketing Manager

Informed consent is an ongoing and dynamic process. When significant changes occur during a trial, Institutional Review Boards (IRBs) often require participants to reaffirm their willingness to continue. Therefore, it is crucial for sponsors and Contract Research Organizations (CROs) to implement a comprehensive strategy for initial consent and subsequent re-consent.

The challenges associated with re-consent are exacerbated by the prevalent use of paper consent forms at many research sites. For instance, after dedicating considerable time to explaining the trial's risks and potential benefits and obtaining signatures, a staff member at a site may discover that the last participant inadvertently signed an outdated version of the consent form. Consequently, they must then investigate how many other outdated copies may have been mistakenly circulated.

In this article, the authors delve into a variety of triggers for initiating re-consent, perspectives of regulators and IRBs regarding the re-consent process, and the role of digital processes in preventing issues related to re-consent.