Pediatric Participation in Non-Therapeutic Research
Article first published online: 12 OCT 2012
© 2012 American Society of Law, Medicine & Ethics, Inc.
The Journal of Law, Medicine & Ethics
Special Issue: SYMPOSIUM 1: Conflicts of Interest in the Practice of Medicine
Volume 40, Issue 3, pages 665–672, Fall 2012
How to Cite
Morris, M. C. (2012), Pediatric Participation in Non-Therapeutic Research. The Journal of Law, Medicine & Ethics, 40: 665–672. doi: 10.1111/j.1748-720X.2012.00697.x
- Issue published online: 12 OCT 2012
- Article first published online: 12 OCT 2012
United Stated federal regulations allow participation of children in greater than minimal risk research with no potential for direct benefit under narrowly defined circumstances. This type of research is controversial, as it runs contrary to the best interest standard, on which we base most decisions made on behalf of children. I argue that such research is ethically defensible if a fully informed, scrupulous, and virtuous parent would choose to enroll his or her child in the study. Further, I defend the current regulations, which allow local Institutional Review Boards to approve more than minimal risk, nontherapeutic research when the research involves children with the medical condition being studied, but requires federal review for similarly risky studies that involve healthy children. Because families of children with medical diseases tend to be more familiar with the health care system and with medical procedures, they are more able to make informed decisions about the burdens of research participation. Further, parents of children with medical conditions have a morally significant interest in advancing medical knowledge about their child's condition. It is appropriate to take this interest into account when evaluating the ethical status of a research study.