Columbia University.
J Law Med Ethics. 2012 Fall;40(3):665-72. doi: 10.1111/j.1748-720X.2012.00697.x.
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.
美国联邦法规允许儿童在限定的特殊情况下参与超出微小风险的研究，即使这些研究没有直接受益的可能。这种类型的研究存在争议，因为它违背了我们为儿童做出大多数决策所依据的最佳利益标准。我认为，如果一位完全知情、谨慎且有道德的父母选择让自己的孩子参加研究，那么这种研究在伦理上是可以辩护的。此外，我还为现行法规辩护，该法规允许地方机构审查委员会在研究涉及正在研究的医疗状况的儿童时，批准超出微小风险的非治疗性研究，但对于同样涉及健康儿童的风险更高的研究，则需要联邦审查。因为患有医疗疾病的儿童的家庭往往更熟悉医疗保健系统和医疗程序，因此他们更能够就研究参与的负担做出明智的决定。此外，患有医疗状况的儿童的父母在推进有关其子女病情的医学知识方面具有重要的道德利益。在评估研究的伦理地位时，考虑到这一利益是恰当的。
