It's A Mad Men World For IRB Review Of Clinical Trial Advertisements

By Peter Vasilenko, Ph.D., Univo IRB Chair

The shift from print and radio to digital platforms, patient recruitment organizations (PROs), and artificial intelligence has outpaced the FDA’s decades-old regulations for clinical trial recruitment. This regulatory lag creates an ethical gray area where generic, marketing-driven campaigns often bypass Institutional Review Board (IRB) oversight. As a result, prospective participants face heightened vulnerabilities to emotional clickbait, blurred boundaries between standard treatment and experimental research, and systemic algorithmic bias during AI-driven electronic health record screening. Learn how IRBs can actively bridge this gap by treating modern digital recruitment as the vital first step of the informed consent process. This piece outlines actionable strategies for reviewing electronic screeners, implementing robust data privacy protections, even when HIPAA does not strictly apply, and evaluating the ethical use of screening chatbots.