Informed Consent And COVID-19: An IRB's Perspective On Navigating The New Normal

By David A. Borasky, MPH, CIP, Vice President, IRB Compliance, and Heather Kim, MS, RAC, CIP, Quality Assurance Manager, WCG IRB

COVID-19 has completely transformed the way patients, sites, sponsors, and CROs engage in clinical research and with each other. Almost every aspect has changed, and many of those changes require IRB notification, so it’s not surprising that we’ve received hundreds of questions from sites and sponsors.

Those questions touch on an array of issues, and those issues have changed over the course of the pandemic. A few, however, have remained constant; for example, we continue to receive questions about informed consent.

As you already know, regulations require initial consent, and they require consent to changes that could affect a participant’s willingness to continue in the trial. However, the regulations don’t detail exactly how.