儿童同意和父母同意进行临床研究——一些考虑因素。

Bioethics forum Pub Date : 2002-01-01
Christian Simon
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引用次数: 0

摘要

我们未来理解和改善儿科知情同意伦理的努力能否成功,在很大程度上可能取决于我们是否愿意和有能力将儿童的同意和父母的同意看作是共同的、相互影响的过程。鉴于目前的趋势,我们的经验努力可能需要在同意和父母许可的界面上展开,而不是只在一个领域或另一个领域。这一转变将使研究人员能够确定这两种机制协同作用的领域——为患者、家长和临床医生带来最大利益——以及那些不协同作用的领域。针对这些有问题的领域进行干预和改进,可能会使涉及未成年人的临床研究获得更有效的同意程序。
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Child assent and parental permission for clinical research--some considerations.

The success of our future efforts to understand and improve the ethics of pediatric informed consent may depend, in large measure, on our willingness and ability to conceive of child assent and parental permission as joint, mutually affective processes. Given current trends, our empirical efforts may need to unfold at the interface of assent and parental permission, rather than exclusively or even primarily in one domain or the other. This shift will permit researchers to identify those areas in which the two mechanisms function in concert--in the best interests of patients, parents, and clinicians--and those in which they do not. Targeting these problematic areas for intervention and improvement may result in a more effective consent process for clinical research involving minors.

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