德国的预先研究指令:披露标准的建议

IF 0.8 Q4 PSYCHOLOGY, DEVELOPMENTAL
M. Scholten, A. Gieselmann, J. Gather, J. Vollmann
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引用次数: 6

摘要

《德国药品法》(Arzneimittelgesetz)第四修正案规定,在潜在的研究参与者明确声明他们希望在预先研究指令中参与科学研究的情况下,允许在不合格人群中进行非治疗性研究。本文探讨了在生物医学研究的国际法律和伦理框架的背景下,在德国实施先进的研究指令。特别地,它解决了一个实际问题,这是由于事先研究指令的披露要求而产生的。我们表明,如果预先研究指令的披露标准设定在一个象征性的水平上,在不称职的人群中进行非治疗性研究实际上是不可能的。为了解决这个问题,我们建议将披露标准设置为类型级别。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Advance Research Directives in Germany: A Proposal for a Disclosure Standard
The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the disclosure requirement for advance research directives. We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level.
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来源期刊
CiteScore
2.00
自引率
0.00%
发文量
30
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