Author’s Response

Three ethical principles govern research with human subjects: respect for persons, beneficence, and justice. Respect for persons demands that, whenever feasible, we ask parents for permission before enrolling their infants in research studies. Beneficence requires us to make sure that the potential risks of any study are balanced by the potential benefits. Both principles require interpretation in light of the particular circumstances of particular trials. Our “Ethics Rounds” article presented a situation in which clinical investigators proposed a study of an unforeseen crisis in the delivery room. In such a circumstance, it would be impossible to adequately inform parents of the potential risks and benefits of enrolling in a study. One must, then, choose 1 of 2 troublesome options: either do the study without the permission of fully informed parents, or not do the study and never know which treatment is safest and most effective for infants. I believe that, in such circumstances, the principle of respect for persons is outweighed by beneficence and justice. Beneficence demands that we do what is best for infants. If we do not know what is best, we have an ethical obligation to find out. Justice demands that the research subjects be selected fairly and that the risks of research be minimized by designing the study as rigorously as possible to answer the study question as efficiently as possible. All future infants will benefit as a result. As both Foglia et al and Feltman suggest, such studies require careful oversight with exquisite attention to safety monitoring. Parents should be fully informed about such studies as soon as it is feasible to do so.