PDF(Pubmed)
Abstract：
In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of Helsinki in favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation.
We distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities\' respective approaches to interpretation and implementation of the Declarations\' placebo paragraph in the conduct of medical research.
Our findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of \"serious harm\" and \"methodological reasons\" are proposed as well as safeguards to avoid abuse of the option to use placebo-controls.
Leaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki\'s character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard.
We distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities\' respective approaches to interpretation and implementation of the Declarations\' placebo paragraph in the conduct of medical research.
Our findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of \"serious harm\" and \"methodological reasons\" are proposed as well as safeguards to avoid abuse of the option to use placebo-controls.
Leaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki\'s character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard.
摘要：
2013年10月，《赫尔辛基宣言》在其50年的历史中进行了第七次修订。虽然这是保护参与医学研究的患者的一套最广泛接受的伦理原则，《赫尔辛基宣言》也一直备受争议。特别是,其关于在临床试验中使用安慰剂对照的段落将研究界分为积极对照和安慰剂正统的支持者，双方都不断要求修改《赫尔辛基宣言》，以支持他们的立场。本项目的目标是将主要的理论争议与监管实施进行比较。
我们向来自不同国家的国家药品监管当局分发了一份调查问卷，以收集有关当局在医学研究中解释和执行《声明》安慰剂段落的各自方法的信息。
我们的研究结果表明，大多数药品监管当局已经建立了一个中间立场的做法，在某些情况下允许安慰剂对照。提出了对“严重伤害”和“方法原因”的各种解释，以及避免滥用使用安慰剂对照的选择的保障措施。
将安慰剂段落开放给各种解释是赫尔辛基宣言作为指导性文件的结果。在当前版本中，争议将继续。应继续加强《宣言》，以加强对以最高道德标准进行医学研究的赞赏。
我们向来自不同国家的国家药品监管当局分发了一份调查问卷，以收集有关当局在医学研究中解释和执行《声明》安慰剂段落的各自方法的信息。
我们的研究结果表明，大多数药品监管当局已经建立了一个中间立场的做法，在某些情况下允许安慰剂对照。提出了对“严重伤害”和“方法原因”的各种解释，以及避免滥用使用安慰剂对照的选择的保障措施。
将安慰剂段落开放给各种解释是赫尔辛基宣言作为指导性文件的结果。在当前版本中，争议将继续。应继续加强《宣言》，以加强对以最高道德标准进行医学研究的赞赏。
