: Bioethicists have failed to understand the pervasively paternalistic character of research ethics. Not only is the overall structure of research review and regulation paternalistic in some sense; even the way informed consent is sought may imply paternalism. Paternalism has limits, however. Getting clear on the paternalism of research ethics may mean some kinds of prohibited research should be reassessed.

Members of institutional review boards that review protocols involving children may not have adequate understanding of pediatric research regulations. We evaluated self-reported preparedness for pediatric protocol review and knowledge of pediatric regulations among members of five IRBs that oversee pediatric research. Of 71 eligible IRB members, 41 responded. We asked respondents to describe their level of preparedness to complete common reviewer tasks and to demonstrate their knowledge of pediatric regulations by responding to five multiple-choice questions. Most respondents considered themselves “well (...) prepared” or “very well prepared” to perform common IRB tasks. However, the median knowledge score was one correct answer. IRB chairs and those who had received lecture-based or seminar-based training in IRB review, especially specific training in pediatric research review, scored higher. These data suggest the need for comprehensive evaluation of IRB member knowledge and for education regarding pediatric research review. (shrink)