Pediatric Drug-Trial Recruitment: An Institutional Review Board Perspective

I thank Tishler and Reiss¹  for their thoughtful article in the May 2011 issue of Pediatrics. I agree that further guidance from regulatory authorities (eg, the US Food and Drug Administration or Office for Human Research Protections) would be useful in regards to the issue of incentives for study participation, because there is significant variation from study to study and even among clinical research sites in the same study.

However, I would like to provide several comments about the authors' conclusions from an institutional review board (IRB) perspective. Although increasing enrollment in clinical trials is an important goal, the ultimate role of an IRB is to ensure the safety of study participants and minimize the risks of a study. Most pharmaceutical studies, by their nature, are RL-2 or RL-3, so they involve more than minimal risk. The authors' equation for increasing payments on the basis of increased risks...