The Legal Ethics of Pediatric Research
Coleman, Doriane Lambelet, Duke Law Journal
Since the mid- to late 1990s, the scientific and medical research community has sought to increase its access to healthy children for research protocols that involve harm or a risk of harm. This move reverses longstanding policy within that community generally to exclude healthy children from such protocols on the grounds that the research as to them is nontherapeutic, that they are particularly vulnerable to research-related abuses, and that they are unable themselves to give informed consent to their participation. The research community's new posture has been supported by prominent pediatric bioethicists who have argued that unless healthy children are included as research subjects in harmful or risky research, the pediatric population will continue to suffer relative to the adult population in the extent to which it benefits from modern advances in science and medicine. In their view, it is possible for the research community to self-administer a rule that strikes a balance between protecting healthy children from research-related abuses and allowing their inclusion in cutting-edge pediatric research. In this scheme, parental consent is central to the research community's claims about child protection.
This Article explores the flaws inherent in this ethics of pediatric research. Specifically, it challenges the view from ethics that the law permits parents to consent to their children's inclusion in harmful or risky research to the extent that related invasions would meet legal maltreatment standards. More broadly, it challenges the movement to increase access to healthy children for harmful and risky research on the ground that it risks two important regressions: First, in its willingness to risk harm to individual children in the interests of the group, it threatens the progress the law has made in its development of the concept of the child as an individual worthy of respect in his or her own right, a concept that imagines parents as fiduciaries and that includes strong protections against invasions of bodily integrity. Second, in its failure to assure that the burdens of nontherapeutic research are not placed disproportionately on children of lower socioeconomic and minority status, it violates the antidiscrimination principle, which has only begun to make good on its promise of equal treatment for all children. Ultimately, this Article argues that harmonization of the rules governing pediatric research with the law of child protection and parents' consent authority is the best way to assure that children are protected in the research setting in these respects and to the same extent they are otherwise in the society.
TABLE OF CONTENTS Introduction I. The Evolving Ethics of Pediatric Research Using Healthy Children II. The Legal Boundaries of Parents' Consent Authority A. The Doctrinal Boundaries of Parents' Consent Authority B. Exceptions to the Proscriptions against Physical Abuse C. Parents' Consent Authority in the Research Setting 1. On Harmful Research 2. On Risky Research 3. On the Benefit the Child Derives from Research 4. On Research as a "De Facto Exception" to Maltreatment 5. The Significance of the Grimes Decision III. An Argument in Favor of a Legal Ethics of Pediatric Research A. The Problem with "Balancing Protection and Access" B. The Merits of Harmonizing the Ethics of Pediatric Research with the Law of Child Protection and Parents' Consent Authority 1. Resolving the Dilemma of Protection and Access 2. A Consistent Commitment to Child Protection Conclusion
A preeminent research institution enrolls a group of infants and young children in a study designed to measure the effects of varying degrees of lead abatement on lead levels in the blood, including by encouraging particular landlords to rent their properties only to families with young children and by encouraging the tenants in those properties to consent to their children's use as research subjects. …