医学与哲学
醫學與哲學
의학여철학
MEDICINE AND PHILOSOPHY
2014年
5期
87-89
,共3页
《赫尔辛基宣言》%医学人体试验%受试者权益
《赫爾辛基宣言》%醫學人體試驗%受試者權益
《혁이신기선언》%의학인체시험%수시자권익
Declaration of Helsinki%medical research involving human subjects%participants’ right
《赫尔辛基宣言》自颁行以来已六次修订,为适应医学研究领域的新情势,世界医学会征询中华医学会对2008年版《赫尔辛基宣言》的修改意见,中华医学会委托医学伦理学分会组织专家进行意见征集与调研活动。在整理和总结上述修订意见的基础上,进一步研究探讨了关于受试者知情同意、受试者风险评估、受试者权益保障、医学伦理委员会伦理监督职能、程序伦理等问题,并提出了基于中国国情的考虑与建议,以期借鉴国际医学伦理典籍,共谋我国医学伦理的发展,为保护受试者方面贡献力量。
《赫爾辛基宣言》自頒行以來已六次脩訂,為適應醫學研究領域的新情勢,世界醫學會徵詢中華醫學會對2008年版《赫爾辛基宣言》的脩改意見,中華醫學會委託醫學倫理學分會組織專傢進行意見徵集與調研活動。在整理和總結上述脩訂意見的基礎上,進一步研究探討瞭關于受試者知情同意、受試者風險評估、受試者權益保障、醫學倫理委員會倫理鑑督職能、程序倫理等問題,併提齣瞭基于中國國情的攷慮與建議,以期藉鑒國際醫學倫理典籍,共謀我國醫學倫理的髮展,為保護受試者方麵貢獻力量。
《혁이신기선언》자반행이래이륙차수정,위괄응의학연구영역적신정세,세계의학회정순중화의학회대2008년판《혁이신기선언》적수개의견,중화의학회위탁의학윤리학분회조직전가진행의견정집여조연활동。재정리화총결상술수정의견적기출상,진일보연구탐토료관우수시자지정동의、수시자풍험평고、수시자권익보장、의학윤리위원회윤리감독직능、정서윤리등문제,병제출료기우중국국정적고필여건의,이기차감국제의학윤리전적,공모아국의학윤리적발전,위보호수시자방면공헌역량。
Declaration of Helsinki has been amended for six times since its enactment in 1964 .To adapt the new trends in medical research ,the World Medical Association has consulted Chinese Medical Association for opinions on the amendments to Declaration of Helsinki (2008) .Chinese Medical Association has entrusted experts from Medical Ethics Branch with the collection and research of the opinions .Based on the organization and summary of these opinions ,this article has further discussed the informed consent ,the risk evaluation ,and the right insurance of the participants ,the supervisory function of the Medical Ethics Committee , procedural ethics ,as well as some considerations and advices conforming to the situation in China ,so as to develop the medical ethics in China and contribute to the protection of the participants .