Children's Consent to Research Participation: Social Context and Personal Experience Invalidate Fixed Cutoff Rules

Abstract

David Wendler and Seema Shah (2003) offer an interesting proposal concerning children’s assent to participation in nontherapeutic biomedical research. They argue that children should be considered competent to consent to such participation provided they have attained a level of cognitive and prosocial development such that they are able to understand the nature and point of altruistic decisions and actions. On the basis of psychological evidence they argue that this develops between the ages of 10 and 14. They argue on practical and moral grounds for an agebased cutoff for assent to research participation at 14 years old. Other commentators on Wendler and Shah’s paper draw attention to a number of moral and practical challenges to this proposal. We would like to draw attention to what we regard as weaknesses in the scientiac basis of the paper. It is important to note that Wendler and Shah start with U.S. federal guidelines, move on to identify the underlying moral principles (drawing heavily on the standard “Four Principles” approach), and only then seek to identify a psychological foundation for the means to apply these principles in practice. Their argument turns on a psychological account of the development of the capacity for altruism as the basis for capacity to assent to participation in nontherapeutic biomedical research. Although there is some analytical interest in the proposition that capacity for altruism is a necessary condition for capacity to assent to participation in nontherapeutic research, had they approached the issue of children’s capacity to consent or assent more directly, they might well have obtained a different result. Most work on research ethics commences, as do Wendler and Shah, with a theoretical and legal analysis of the requirements for ethical research. Occasionally, empirical work is conducted to determine the acceptability of guidelines or policy in the aeld of research ethics. Yet we have found almost no research that seeks to analyze in any detail research participants’ reasoning and values concerning the ethical issues in research, or to understand how far the ethical issues identiaed by research participants are consistent with the issues raised by ethicists or ethical