Diamant J C
Scripps Clinic Department of Graduate Medical Education, Scripps Clinic, La Jolla, CA 92037, USA.
Int J Clin Pharmacol Ther. 2002 Feb;40(2):76-83. doi: 10.5414/cpp40076.
The World Medical Association revised the Declaration of Helsinki in October 2000. The Declaration is intended to provide a universal set of principles, which direct the ethical conduct of clinical medical research involving human subjects throughout the world. Previous research ethics codes emphasized the principles of informed consent and beneficence toward research subjects. The revised Helsinki Declaration places a premium not only upon these values but also the principle of distributive justice. The new Declaration demands that scientists see to it that the risks and benefits of scientific inquiry are distributed fairly to those that participate in research and to the communities from where participants are drawn. The authors of the Declaration have sought to establish justice by minimizing the use of placebo controls, insisting that populations from where research subjects are drawn stand to benefit from the research, and by requiring that therapeutic agents be made available to all trial participants long after a trial is completed. This paper argues that the aim of seeking a morejust distribution of the risks and benefits of research may actually be undermined by the tools that the Declaration employs to enforce justice.
世界医学协会于2000年10月修订了《赫尔辛基宣言》。该宣言旨在提供一套通用原则,指导全球范围内涉及人类受试者的临床医学研究的伦理行为。以往的研究伦理准则强调对研究受试者的知情同意原则和行善原则。修订后的《赫尔辛基宣言》不仅重视这些价值观,还重视分配正义原则。新宣言要求科学家确保科学探究的风险和益处公平地分配给参与研究的人员以及招募受试者的社区。宣言的作者试图通过尽量减少安慰剂对照的使用、坚持招募研究受试者的人群应从研究中受益以及要求在试验完成很久之后向所有试验参与者提供治疗药物来建立正义。本文认为,寻求更公正地分配研究风险和益处的目标实际上可能会被宣言用来实施正义的手段所破坏。