《赫尔辛基宣言》修订与受试者权益保障

摘要

Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects is adopted by 64th WMA General Assembly in October 2013. The revision is better readability by reorganizing and restructuring the document with sub headings, more protection for vulnerable groups, more protections for participants by including the issue of compensation for the first time, more precise and specific requirements for post-study arrangements, a more systematic approach to the use of placebos but no weakening of the ethics of placebo use.%2013年10月第64届世界医学大会对《赫尔辛基宣言》修订，改变的主要内容为便于阅读和把握宣言的体系增加了小标题，首次提出研究所致受试者伤害的赔偿规定，更注重保护弱势群体受试者，对试验完成后受试者权益保障更加明确具体，安慰剂使用（非干预措施）更加体系化且不弱化伦理要求等。