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《赫尔辛基宣言》修订与受试者权益保障 被引量:32

The revision of Declaration of Helsinki and human subject protection
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摘要 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。 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.
作者 姚树森 范贞
出处 《中国医院》 2014年第2期51-53,共3页 Chinese Hospitals
关键词 赫尔辛基宣言 福塔雷萨 受试者权益 Declaration of Helsinki Fortaleza subject's rights
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参考文献5

  • 1World Medical Association. World Medical Association Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects[J].{H}JAMA:the Journal of the American Medical Association,2013,(20):2191-2194.
  • 2WMA Declaration of Helsinki Working Group. Draft revised text for public consultation,15 April-15 June 2013 Annotated version[EB/OL].http://www.wma.net/en/20activities/10ethics/10helsinki/15publicconsult/DoH-draft-for-public-consultation_annotated.pdf,2013.
  • 3University of Michigan. Guidelines for using magnitude of harm in categorizing risk level[EB/OL].http://medicine.umich.edu/medschool/sites/medicine.umich.edu.medschool/files/res_irbmed_Risk-guide.pdf,2013.
  • 4FDA. Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application[EB/OL].http://www.gpo.gov/fdsys/pkg/FR-2008-04-28/pdf/E8-9200.pdf#page=1,2013.
  • 5Patricia LB,Lawrence WV. Clinical research compliance manual:an administrative guide[M].New York:Wolters Kluwer Law & Business,2012.12-20,21.

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