Do informed consent documents for cancer trials do what they should? A study of manifest and latent functions
Do informed consent documents for cancer trials do what they should? A study of manifest and latent functions
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DOI：
10.1111/j.1467-9566.2012.01469.x
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发表时间：
2012-11-01
影响因子：
2.9
通讯作者：
Tarrant, Carolyn
中科院分区：
文献类型：
--
作者：
Armstrong, Natalie;Dixon-Woods, Mary;Tarrant, Carolyn
虽然向受邀参加医学研究的患者提供了患者信息传单（PIL），但它们通常无法促进有关参与的知情决定。我们的目的是探索为什么有一个持久的要求，似乎没有“工作”的过程，并解释为什么问题已被证明是抗拒纠正。我们分析了13项肿瘤学试验的伦理批准申请和相关的官方指南。我们采访了26名受邀参加试验的患者。数据分析采用常数比较法。我们发现，PIL的功能潜在地满足其作为决策促进工具的明确功能以外的目的。PIL是一个机构脚本过程的结果，该过程受到道德审查过程中固有的问责要求的强烈影响。这就导致了公益金既可以作为招股说明书，也可以作为合同。虽然PIL对一些患者有价值，但大多数人并不认为这些文件主要是为了他们的利益而运作的。病人做出的决定偏离了官方的理想。这一分析对于认识到没有简单的技术解决办法以及加强对文件的制度作用的社会学理解非常重要。
Though patient information leaflets (PILs) are provided to those invited to take part in medical research, they usually fall short in facilitating informed decisions about participation. We aimed to explore why there is an enduring requirement for a process that seems not to 'work', and to explain why the problems have proven resistant to correction. We analysed applications for ethical approval for 13 oncology trials and related official guidance. We interviewed 26 patients invited to participate in the trials. Data analysis was based on the constant comparative method. We show that PILs function latently to satisfy purposes other than their manifest function as a decision-facilitating tool. PILs are the outcome of a process of institutional scripting that is strongly shaped by the accountability demands inherent in the ethical review process. This results in the PIL being made to serve purposes both as a prospectus and as a contract. Though PILs have value for some patients, most do not recognise these documents as operating primarily in their interests. Patients make decisions in ways that deviate from official ideals. This analysis is important in recognising that no simple technical fix is available, and in enhancing sociological understanding of the institutional role of documents.