Federal regulations require IRBs to review how clinical trials recruit participants, yet the FDA’s core guidance on the subject is nearly three decades old. Since 1998, participant recruitment has moved from print, radio, and television to digital platforms, social media, patient recruitment organizations (PROs), and artificial intelligence (AI), raising ethical questions that older guidance never anticipated.
What are IRBs supposed to do?
This article answers that question, examining:
- How modern recruitment methods, including PROs and AI-driven tools, create gaps that existing guidance doesn’t fully address
- Why IRB review of clinical trial advertisements still matters for protecting participants from undue influence, misleading claims, and privacy risks
- What IRBs can do now, from reviewing generic and digital recruitment materials to evaluating electronic eligibility screeners that collect personal health information
Until regulations catch up with modern advertising and AI-driven recruitment, enduring ethical principles remain the clearest path to keeping recruitment materials truthful, respectful, and protective of the people research is meant to serve.
Read the full article on Clinical Leader.
