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.
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。