Informed consent: Time for a national dialogue?

Abstract

“Respect for persons” is the first of the 3 ethical principles underlying the conduct of research in human beings.1 This principle is intended to allow voluntary participation in research and is usually implemented as informed consent of subjects. But has this principle become overshadowed by its implementation process? In the Belmont Report, the original document elucidating the 3 principles, the explanation of “respect for persons” is much broader than simply informed consent.1 The Belmont Report states: 1. Respect for persons: Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.1 In this issue of Annals, Young et al2 have presented a study designed to answer an important clinical question: in children with moderate to severe blunt head trauma, is phenytoin effective in the prevention of early posttraumatic seizures? Among the many interesting aspects of this study, the issue of informed consent (more correctly, parental permission) was central to the study conduct and to the eventual decision to stop the trial early, which resulted in a less certain answer to the study question. Thus, how much more do clinicians now know about whether to administer phenytoin when a child with blunt head trauma presents to the emergency department? The subjects in this study had diminished autonomy by virtue of their age. Children are one of the categories of vulnerable subjects specifically named in the Federal Regulations for Protection of Human Subjects, and there is a separate set of regulations devoted specifically to research in children.3 Research in children generally requires the permission of the parent or guardian, as well as assent of the child when appropriate. In 1996, both the Department of Health and Human Services and the US Food and Drug Administration issued amendments to their regulations allowing the waiver of consent requirements in certain emergency research.4 Biros,5 in her recent review, describes the history leading to the promulgation of these regulations, the justification for the requirements, and potential methods of implementation. She explains that these regulations were developed to address the relatively clear, but narrow, situation in which (1) the potential subject is in a life-threatening situation and is unable to consent, (2) the time window for intervention is short, and (3) there is no legally authorized representative available to provide consent within the time window. Had the study by Young et al2 been conducted today rather than before these new regulations, the investigators may have chosen to apply for a waiver of consent. If approved by the institutional review board, subjects could have been enrolled in the study without parental permission if their parents or legal guardians (legally authorized representatives, in regulatory terms) were not present or available within 60 minutes of the injury, the time window for the intervention. But what happens when the parent or guardian is available? Might the legally authorized representative also be vulnerable? The ethical principle is “respect for persons,” not autonomy. When one is ill or injured, might not the condition itself result in decreased autonomy, to a lesser or greater degree depending on the extent of the illness or injury? Emotional stress can result in difficulty processing complex medical information, both about the current illness or injury and the proposed research.6 That diminished information processing can P E D I A T R I C S / E D I T O R I A L