Altruistic discourse in the informed consent process for childhood cancer clinical trials

Altruistic discourse in the informed consent process for childhood cancer clinical trials
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DOI:
10.1080/15265160600862395
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发表时间:
2006-09-01
影响因子:
13.4
通讯作者:
Siminoff, Laura
Siminoff, Laura
中科院分区:
人文科学1区
文献类型:
--
作者:
Simon, Christian;Eder, Michelle;Siminoff, Laura

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学者们一直在争论利他主义考虑在临床试验的招募和决策过程中发挥的作用--也应该发挥作用。几乎没有经验数据来支持他们的不同观点。我们分析了140次录音的儿科知情同意会议,其中95次(68%)包括至少一次关于参与癌症临床试验可能如何受益的讨论:1)一般地追求科学知识;2)其他患有癌症的儿童;以及3)“未来”和其他模糊定义的接受者。临床医生发起了大多数(80%)关于利他主义的讨论。总体来说,参加临床试验的儿童的注册率很高(83%),但在父母参与以利他为导向的讨论的儿童中,注册率并不高。这些发现表明:(1)临床医生引用了一系列利他主义考虑,而不是单一的利他主义概念,以及(2)利他主义考虑对随后的入选决定的影响是微乎其微的。虽然对这一主题的进一步研究是有必要的,但生物伦理学辩论应该努力反映临床研究中利他主义话语的多样性,并将这种话语置于包括非利他主义在内的其他考虑的背景下。
Scholars have debated the role that altruistic considerations play-and should play-in recruitment and decision-making processes for clinical trials. Little empirical data are available to support their various perspectives. We analyzed 140 audiotaped pediatric informed consent sessions, of which 95 (68%) included at least one discussion of how participation in a cancer clinical trial might benefit: 1) the pursuit of scientific knowledge generally; 2) other children with cancer specifically; and 3) "the future" and other vaguely defined recipients. Clinicians initiated most (80%) of these discussions of altruism. The enrollment rate of children in the clinical trial was high (83%) overall, but not higher among children whose parents were involved in an altruism-oriented discussion. These findings suggest that: (1) clinicians invoke a spectrum of altruistic considerations rather than a single monothematic notion of altruism, and (2) the effect of altruistic considerations on subsequent enrollment decisions is marginal. While further research on this topic is warranted, bioethical debate should strive to reflect the diversity of altruistic discourse in clinical research encounters and to place this discourse in the context of other, including nonaltruistic, considerations.