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Children's Consent to Research Participation: Social Context and Personal Experience Invalidate Fixed Cutoff Rules
- The American Journal of Bioethics
- The MIT Press
- Volume 3, Number 4, Fall 2003
- pp. 16-18
- Article
- Additional Information
The American Journal of Bioethics 3.4 (2003) 16-18
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Children's Consent to Research Participation:
Social Context and Personal Experience Invalidate Fixed Cutoff Rules
Richard Ashcroft,
Imperial College London, United Kingdom
Trudy Goodenough
University of Bristol, United Kingdom
Emma Williamson
University of Bristol, United Kingdom
Julie Kent
University of the West of England, United Kingdom
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 age-based 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 scientific 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 field 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 identified by research participants are consistent with the issues raised by ethicists or ethical committees.
We have conducted a three-year qualitative research study into both adult and child research participants' attitudes and values concerning nontherapeutic biomedical research (Goodenough et al. 2003; Williamson n.d.1). We conducted a series of interviews with adults and children who were participating in a large longitudinal cohort study, supplemented by a number of focus groups with adults and with children; and by interviews with some adults who were not participants in the longitudinal cohort study. Our aims included the following: "To improve understanding of children's capacity to make decisions about their participation in genetic and other clinical testing in nontherapeutic research;" and "To improve understanding of the issues children and adults regard as important and of concern, and their views on appropriate ethical protection."
The methodological contrast between our work and Wendler and Shah's is that, so far as possible, we tried to "bracket out" the questions of what the "real" ethical issues and the "correct" ethical guidelines were in order to understand the actual situated reasoning of people faced by practical decisions about research participation. In particular, in our work with children we paid close attention to the types of reasoning and understanding used by children to describe and evaluate p
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