Providing Research Participants With New Information – Is Re-Consent Always Necessary

By Currien MacDonald, MD, CIP, IRB Chair, WCG IRB, and R. Bert Wilkins, JD, MHA, CIP, IRB Chair, WCG IRB

In an ever-changing clinical research landscape, it is critical that we are agile, flexible, and quick to adapt to change. But what if that change impacts currently enrolled study participants? How do we communicate changes to the study effectively and in line with regulatory guidance? This whitepaper provides tips and strategies for how to handle consent documentation with participants when new information becomes available.