The ethics of “net-risk” pediatric research: views of institutional review board members and the US public

Abstract

Background US regulations allow institutional review boards (IRBs) to approve “net-risk” pediatric research only when the risks are minimal or a minor increase over minimal. This study assessed whether IRB members agree with these risk limits and compared their views with those of US adults. Procedure An online survey was conducted for IRB members. The participants were randomized to one out of four studies, which pose increasing risks. They were asked to evaluate three versions of the assigned study that offer increasing potential social value. Results A total of 107 individuals met the inclusion criteria. Overall, 98% of the respondents indicated that net-risk pediatric research can be appropriate. Of the 77 respondents who passed the comprehension test, more than 90% indicated that a research blood draw can be appropriate. A majority endorsed a research bone marrow biopsy. Lastly, a majority supported somewhat greater risks when the study has high potential social value. The percentage of those who indicated that the specified research procedure was appropriate increased as the potential social value increased. Compared with US adults, the IRB members were more likely to think that net-risk pediatric research is appropriate when the risks are low but less likely when the risks are higher. Conclusions Most IRB members consider it appropriate to expose children to some research risks for the benefit of others. Moreover, a majority think that greater risks can be appropriate when the research has greater potential social value. These findings, together with similar findings from US adults, suggest that current regulations for pediatric research may be overly restrictive.