Ethical and legal considerations associated with clinical field trials

As members of a hypothetical review board, we have evaluated the protocol of a clinical caries trial following the recommendations proposed by the National Commission. The potential risks to the subjects were described as well as the potential benefits that both the participants and society might derive from the study. A new element of the institutional review process was the determination of the scientific validity of the study. The Commission was cautious in indicating that, while such a review should be conducted, studies of marginal scientific importance might be allowed, as long as the risks were minimal. Clinical studies of cariostatic agents traditionally use children as subjects. The rights of children as research subjects were addressed in detail by the Commission. Its recommendation that "assent" of the children be secured is significant. Nevertheless, the Commission distinguished between consent and assent. Consent of parents must be actively secured while assent of the children is acquired by their passive acquiescence to participation. We have raised questions at a practical level throughout this presentation in order to stimulate discussion. These questions, however, do not have simple answers. In the time remaining, we trust the complex issues involved will be discussed further.