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首页> 外文期刊>BMC Medical Ethics >Ethical principles and placebo-controlled trials – interpretation and implementation of the Declaration of Helsinki’s placebo paragraph in medical research
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Ethical principles and placebo-controlled trials – interpretation and implementation of the Declaration of Helsinki’s placebo paragraph in medical research

机译：伦理原则和安慰剂对照试验–赫尔辛基安慰剂宣言在医学研究中的解释和实施

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摘要

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.
机译：2013年10月，赫尔辛基宣言在其50年的历史中第七次被修订。虽然这是保护参加医学研究的患者的最广泛接受的道德原则，但赫尔辛基宣言也一直引起争议。特别是，其有关在临床试验中使用安慰剂对照的段落将研究界分为主动对照和安慰剂正统支持者，两者都不断要求对《赫尔辛基宣言》进行修订以支持其立场。本项目的目的是将主要的理论争议与法规实施进行比较。我们向来自不同国家的国家药品监管机构分发了一份调查问卷，以收集有关当局在医学研究过程中解释和实施《宣言》安慰剂段落的各自方法的信息。我们的研究结果表明，大多数药物监管机构已确立了中间立场，在某些情况下允许使用安慰剂进行控制。提出了对“严重伤害”和“方法论原因”的各种解释，以及为避免滥用安慰剂对照选择而采取的保护措施。赫尔辛基宣言作为指导文件的结果使安慰剂段落可以进行各种解释。对于当前版本，争议将继续。应当继续加强《宣言》，以加强对以最高道德标准进行医学研究的赞赏。

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