This article argues that investigators doing developmental and social research with children have, for the most part, failed to acknowledge the inherent implications of their work for children's rights. The impact of these studies upon children's rights occurs at every stage; from hypothesis formulation to hypothesis testing to dissemination of findings. This paper addresses the issue in the context of developmental research on children's ability to report experienced events accurately. This particular research area has generated data that has been extrapolated (...) to legal contexts and created a foundation for assumptions about the credibility of child witnesses. This in turn has had profound effects on children's right to be heard and the weight given to their testimony. The argument is made that there is a need for social scientists to explicitly articulate how their work may impact upon children's rights and what is in fact the social agenda in this regard underlying their research. (shrink)

Until a few years ago, the prevailing view was that children should not be participants in clinical research trials because children were incapable of consenting to such nontherapeutic interventions and are particularly vulnerable to abuse. That view has undergone a significant shift in the last few years, particularly in the context of trials to test the safety and effectiveness of drugs. A number of events facilitated this change, including the widespread off-label distribution of drugs to children and developments in the (...) AIDS epidemic. These social forces have shifted the core ethical question from whether children should be research subjects to when children should be research subjects.The presumption in favor of including children as research subjects for drug trials has manifested itself primarily through two different reforms: a 1997 federal statute and a set of regulations promulgated by the Food and Drug Administration that recently became effective. Together they reflect the view that children deserve the same access to safe and effective therapies as adults. (shrink)

How may children and other dependent individuals are subjects in research projects to which they cannot consent and from which they cannot benefit? This topic was much discussed in the United States about twenty-five years ago, but has recently reemerged in the discussion of the European Convention on bioethics and through current discussion in the medical literature of the kinds of consent and experiments appropriate in the Third World. I summarize the U.S. discussion and "solution," present the current European discussion, (...) and conclude with a proposal for understanding and organizing the participation of dependent people in medical experiments. Most of the attempts to understand dependent individuals’ participation in nontherapeutic experiments have attempted to assimilate that participation to a model of informed consent appropriate for adults. I argue that such understanding is false to the nature both of dependency and non-therapeutic experiments. The dependency of childhood, which serves my model, is best viewed in the context of a family committed to the full development of children. Given that commitment, the family involves itself in many activities in the hope of the physical, intellectual and moral development of its members. Non-therapeutic experiments are best seen, not in terms of risk, but in terms of the time and energy commitments they require of participants. Given these understandings of dependency and non-therapeutic experiments, I argue that care-givers are competent to involve themselves and their dependents in scientific work. (shrink)

ABSTRACT A complex problem exists about how to promote the best interests of children as a group through research while protecting the rights and welfare of individual research subjects. The Nuremberg Code forbids studies without consent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Council for the International Organizations of Medical Science, the U.S. Federal Research Guidelines, and many other national policies. (...) They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how to balance them nor explain the meaning of pivotal concepts, like “minimal risk.” Paths to the improvement of balancing or consequentialist approaches include improving standardizing of risk assessment, rejecting crude utilitarianism, identifying and justifying normative or moral judg-ments, and acknowledging extra-regulatory thresholds and deontological or non-negotiable duties to children. (shrink)