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Should routine childhood immunizations serve as an exemplar of minimal risk in United States regulation of research involving children? A closer look at the minimal risk threshold

机译：在美国有关儿童研究的法规中，常规的儿童免疫接种是否应作为最小风险的典范？仔细研究最小风险阈值

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摘要

The title question serves as the framework for a clinical research ethics inquiry having both regulatory and clinical implications. The overall structure of the inquiry is shaped by an hypothesis gleaned from the works of Paul Ramsey. That hypothesis states that acceptable risk in medical practice can become conflated for purposes of "minimal risk" in research practice involving children. The result of such conflation is that risk justified by therapeutic benefit may become analogized to research risk justified on the basis of social aims. The project as a whole utilizes historical and comparative methods to press Ramsey's notion in regard to the RCI Exemplar Question.;The dissertation is divided into two parts. Chapters I--IV explore the political roots of informed consent. Risk-minimizing philosophy inherent in early consent theory provides historical access to a paradigm focused upon managing transference between medical authority over therapeutic risk and medical authority over risk/benefit analysis in research practice. That paradigm is the Nuremberg Code. Historical material regarding the Nuremberg Doctors' Trial is distilled, leading to the Nuremberg Method, a descriptive methodology. I conclude Part I by demonstrating the qualitative measures possible when using the Method to elucidate development of World Medical Association ethics codes from 1949 to 1996, particularly as it reveals the reclamation of medical authority over research practice.;Part II is formulated as a regulatory and clinical analysis of research involving children. Current U.S. human subjects protections regulations are reviewed, critiqued by way of the Method, and then considered for their practical significance (Chapters V--VII). The RCI exemplar is tested for risk conflation by means of case analysis using recent research published in the Journal of the American Medical Association (Chapter VIII). I conclude that the National Commission's assignment of the RCI exemplar undermines special protections for research involving children and is thus unacceptable.
机译：标题问题是具有法规和临床意义的临床研究伦理调查的框架。询问的整体结构由Paul Ramsey的著作得出的假设构成。该假设指出，出于涉及儿童的研究实践中的“最小风险”的目的，可以混淆医学实践中可接受的风险。这种混淆的结果是，以治疗利益为依据的风险可能会类似于基于社会目标而证明的研究风险。该项目作为一个整体，利用历史和比较方法对RCI示例问题提出了Ramsey的观点。论文分为两个部分。第一至第四章探讨了知情同意的政治根源。早期同意理论中固有的最小化风险哲学提供了对范式的历史访问，该范式集中于管理研究实践中对治疗风险的医学权威与对风险/收益分析的医学权威之间的转移。这种范例就是纽伦堡法典。关于纽伦堡医生审判的历史资料被提炼，导致了纽伦堡方法，一种描述性方法。在第一部分的结尾，我将展示当使用该方法阐明1949年至1996年世界医学协会伦理规范的发展时可能采取的定性措施，尤其是因为它揭示了医学权威在研究实践中的收回。临床研究涉及儿童。审查当前的美国人类受试者保护条例，通过该方法对其进行批评，然后考虑其实际意义（第五章至第七章）。 RCI示例通过使用美国医学协会杂志（第VIII章）上发表的最新研究的案例分析来测试风险合并。我得出的结论是，全国委员会对RCI示例的指派破坏了对涉及儿童的研究的特殊保护，因此是不可接受的。

著录项

  • 作者

    McBay, Marian Yagel.;

  • 作者单位

    Vanderbilt University.;

  • 授予单位 Vanderbilt University.;
  • 学科 Philosophy.;Public health.
  • 学位 Ph.D.
  • 年度 2001
  • 页码 567 p.
  • 总页数 567
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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