Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical (...) and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses. (shrink)

Institutional review boards have a dual goal: first, to protect the rights and welfare of human research subjects, and second, to support and facilitate the conduct of valuable research. In striving to achieve these goals, IRBs must often consider conflicting interests. In the discussion below, we characterize research oversight as having three elements: research regulations, which establish a minimum acceptable standard for research conduct; ethical principles, which help us identify and define relevant ethical issues; and virtue ethics, which guides the (...) prioritization of relevant issues. We describe specific ways in which the lessons of virtue ethics suggest revisions to the IRB structure and review process, the education and training of IRB members, and the appropriate limits of regulations in research ethics oversight. (shrink)

Background: Brain-dead humans retain many of the physiologic functions of living humans, but they are legally dead and cannot be physically harmed by participation in research. Stakeholder opinions...