药物临床试验受试者权益保护的述评及策略探讨
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摘要
阐述了药物临床试验受试者权益保护的历史与发展的背景,全面介绍了受试者应享有的受尊重权、知情权、自主决定权、隐私权、补偿权、免费治疗权以及赔偿权等主要权益,并对其概念和特点进行了界定和诠释。进一步针对不同分期的药物临床试验的特点,分析受试者权益没有得到完善保护的方面。在已有的历史经验教训基础上,分析不同分期药物临床试验的受试者权益保护的薄弱环节,探讨受试者权益保护的改善策略,包括:加强教育培训及宣传;完善伦理审查管理机制;建立风险保障机制。
This article has reviewed history and development of participants' rights protection,elaborated on definition and characteristics of participants' rights including respect,information,autonomy,privacy,free medical treatment,compensation and other main rights,analyzed the weakness of participants' rights protection in consideration of different stages of clinical trials and explored strategies of participants rights protection,including: strengthening education training and publicity; improving the management of ethical review mechanism; establishing risk security mechanism.
This article has reviewed history and development of participants' rights protection,elaborated on definition and characteristics of participants' rights including respect,information,autonomy,privacy,free medical treatment,compensation and other main rights,analyzed the weakness of participants' rights protection in consideration of different stages of clinical trials and explored strategies of participants rights protection,including: strengthening education training and publicity; improving the management of ethical review mechanism; establishing risk security mechanism.
引文
[1]国家食品药品监督管理局.药物临床试验质量管理规范[EB/OL]http:∥www.sda.gov.cn/ws01/CL0053/24473.html,2003-08-06.
[2]陈元方,邱仁宗.生物医学研究伦理学[M].北京:中国协和医科大学出版社,2003:87-88.
[3]朱伟.生命伦理中的知情同意[M].上海:复旦大学出版社,2009:209-210.
[4]滕黎,蒲川.伦理审查委员会的法律地位初探[J].医学与哲学:人文社会医学版,2009,30(15):48-49,71.
[5]唐红.药品人体试验中受试者权益保护问题探究[D].武汉:华中科技大学,2009.
[6]Jefford M,Moore R.Improvement of informed consent and the quality of consent documents[J].Lancet Oncol,2008,9(5):485-493.
[7]王德彦.论知情同意的本质及其要素[J].中国医学伦理学,2001,(5):24-25.
[8]郑逸飞,姜柏生,张馥敏,等.论药物临床试验中知情同意权的内涵及保护[J].中国卫生事业管理,2011,28(4):278-279,285.
[9]姜萍,殷正坤.人体研究中的知情同意问题研究综述[J].哲学动态,2002,(12):29-32.
[10]Paul S.Appelbaum,Charles W.Lidz,Alan Meisel.Informed Consent:Legal Theory and Clinical Practice[M].New York:Oxford University Press,1987:23.
[11]刘夕宁,汪秀琴.涉及人体医学研究中关于隐私的保护[J].世界中西医结合杂志,2010,5(2):167-168,170.
[12]李雪梅,李娅杰.新药临床试验伦理审查过程中受试者权益保护的探析[J].中国医学伦理学,2009,22(3):84-85,94.
[13]国家食品药品监督管理局.药品注册管理办法[EB/OL]http:∥www.sda.gov.cn/ws01/CL0053/24529.html,2007-07-10.
[14]Faden Ruth,Beauchamp Tom.A History of Infomed Consent[M].New York:Oxford Uni Versity Press,1986:123-125.
[15]Henry Beecher.Ethics and Clinical Research[J].The New England Journal of Medicine,1966,274:1354-1360.
[16]Rowbotham MC,Astin J,Greene K,et al.Interactive informed consent:randomized comparison with paper consents[J].PLoS One,2013,8(3):e58603.
[17]Steinbrook,Robert.Improving protection for research subjects[J].The New England Journal of Medicine,2002,348(18):1425-1430.
[18]邱仁宗,翟晓梅.有关机构伦理审查委员会的若干伦理和管理问题[J].中国医学伦理学,2013,26(5):545-550.
[19]薛毅.涉及人的生物医学研究中保护受试者权益问题研究[D].锦州:辽宁医学院,2012.
[20]周晔,宋民宪.药物临床试验中侵权责任与违约责任的竞合探析——以受试者权利保护为视角[J].医学信息,2014,(5):59.
[2]陈元方,邱仁宗.生物医学研究伦理学[M].北京:中国协和医科大学出版社,2003:87-88.
[3]朱伟.生命伦理中的知情同意[M].上海:复旦大学出版社,2009:209-210.
[4]滕黎,蒲川.伦理审查委员会的法律地位初探[J].医学与哲学:人文社会医学版,2009,30(15):48-49,71.
[5]唐红.药品人体试验中受试者权益保护问题探究[D].武汉:华中科技大学,2009.
[6]Jefford M,Moore R.Improvement of informed consent and the quality of consent documents[J].Lancet Oncol,2008,9(5):485-493.
[7]王德彦.论知情同意的本质及其要素[J].中国医学伦理学,2001,(5):24-25.
[8]郑逸飞,姜柏生,张馥敏,等.论药物临床试验中知情同意权的内涵及保护[J].中国卫生事业管理,2011,28(4):278-279,285.
[9]姜萍,殷正坤.人体研究中的知情同意问题研究综述[J].哲学动态,2002,(12):29-32.
[10]Paul S.Appelbaum,Charles W.Lidz,Alan Meisel.Informed Consent:Legal Theory and Clinical Practice[M].New York:Oxford University Press,1987:23.
[11]刘夕宁,汪秀琴.涉及人体医学研究中关于隐私的保护[J].世界中西医结合杂志,2010,5(2):167-168,170.
[12]李雪梅,李娅杰.新药临床试验伦理审查过程中受试者权益保护的探析[J].中国医学伦理学,2009,22(3):84-85,94.
[13]国家食品药品监督管理局.药品注册管理办法[EB/OL]http:∥www.sda.gov.cn/ws01/CL0053/24529.html,2007-07-10.
[14]Faden Ruth,Beauchamp Tom.A History of Infomed Consent[M].New York:Oxford Uni Versity Press,1986:123-125.
[15]Henry Beecher.Ethics and Clinical Research[J].The New England Journal of Medicine,1966,274:1354-1360.
[16]Rowbotham MC,Astin J,Greene K,et al.Interactive informed consent:randomized comparison with paper consents[J].PLoS One,2013,8(3):e58603.
[17]Steinbrook,Robert.Improving protection for research subjects[J].The New England Journal of Medicine,2002,348(18):1425-1430.
[18]邱仁宗,翟晓梅.有关机构伦理审查委员会的若干伦理和管理问题[J].中国医学伦理学,2013,26(5):545-550.
[19]薛毅.涉及人的生物医学研究中保护受试者权益问题研究[D].锦州:辽宁医学院,2012.
[20]周晔,宋民宪.药物临床试验中侵权责任与违约责任的竞合探析——以受试者权利保护为视角[J].医学信息,2014,(5):59.