Leske G S, Ripa L W
J Dent Res. 1980 Jul;59(Spec Issue C):1243-53. doi: 10.1177/002203458005900311011.
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.
作为一个假设的审查委员会的成员，我们按照国家委员会提出的建议评估了一项临床龋齿试验的方案。描述了对受试者的潜在风险以及参与者和社会可能从该研究中获得的潜在益处。机构审查过程的一个新要素是确定研究的科学有效性。委员会谨慎地指出，虽然应该进行这样的审查，但只要风险最小，具有边际科学重要性的研究也可能被允许。传统上，抑龋剂的临床研究以儿童为受试者。委员会详细讨论了儿童作为研究受试者的权利。其关于确保儿童“同意”的建议意义重大。然而，委员会区分了同意和赞同。必须积极获得父母的同意，而儿童的赞同是通过他们对参与的被动默认获得的。在本报告中，我们在实际层面提出了一些问题，以激发讨论。然而，这些问题并没有简单的答案。在剩下的时间里，我们相信将进一步讨论所涉及的复杂问题。
