|
|
Some thoughts on strengthening ethical review in clinical research |
HU Zhimin |
Institute of Medical Information, Chinese Academy of Medical Sciences, Beijing 100020, China |
|
|
Abstract Ethical review is a key measure to ensure that clinical research is used for medical purposes and to protect the health and dignity of subjects. This paper reviews the exploration and practice of ethical review in China in recent years, points out that there are some outstanding problems and challenges in the current ethical review, such as the unsound legal system, the lack of independence and standardization, the imperfect mode of review, the insufficient ability of review and the weak mechanism of supervision, and focuses on the measures and suggestions to strengthen ethical review in clinical research by the means of adhering to the guidance of the legal system, enhancing the independence and impartiality of review, coordination and complementarity of various review models, improving capacity and efficiency, and strengthening supervision, in order to better protect the rights and interests of subjects and promote the healthy development of clinical research.
|
|
|
|
|
[1] 武阳丰.如何做好临床研究之我见[J].北京大学学报:医学版,2010,42(6):619-620.
[2] 李雪迎.医学研究中的伦理学基本原则[J].中国介入心脏病学杂志,2012,20(6):306.
[3] 张妞,张涛,徐菊华.中国医院伦理委员会发展的回顾与思考[J].医学与哲学,2017,38(11A):14-17.
[4] 王辉,陈静,李幼平,等.中国临床研究伦理的发展与变革[J].中国循证医学杂志,2018,18(8):769-775.
[5] 《药物临床试验伦理审查工作指导原则》发布施行[EB/OL].(2010-11-08)[2020-03-02].http://www.gov.cn/gzdt/2010-11/08/content_1740976.htm.
[6] 梁虹,Jeffery Cohen,时占祥.多中心临床试验伦理审查模式:实践与启示[J].中国医学伦理学,2016,29(3):461-464.
[7] 关于《涉及人的生物医学研究伦理审查办法》的解读[EB/OL].(2016-11-04)[2020-02-28].http://www.nhc.gov.cn/qjjys/s3580/201611/e83d2ecb1e6645999437506a4e060a27.shtml.
[8] 中共中央办公厅,国务院办公厅.关于深化审评审批制度改革鼓励药品医疗器械创新的意见[EB/OL].(2017-10-08)[2020-03-02]. http://www.gov.cn/zhengce/2017-10/08/content_5230105.htm.
[9] 中国临床研究能力提升与受试者保护高峰论坛(CCHRPP).临床研究伦理协作审查共识(试行版)[EB/OL].(2017-12-28)[2020-03-17]. https://m.sohu.com/a/2134076 38_776163/.
[10] 黄旭,汪秀琴.关于多中心临床试验伦理协作审查的思考[J].中国新药杂志,2018,27(11):1290-1293.
[11] 孙冬莹.论区域伦理委员会的建设[J].中国医学伦理学,2018,31(9):1166-1169.
[12] 北京首试点3家三甲医院互认伦理协作审查[EB/OL].(2019-01-29)[2020-03-06]. http://news.sina.com.cn/c/2019-01-29/doc-ihrfqzka2099667.shtml.
[13] 周吉银,刘丹.我国受试者保护体系的现状与构建[J].中国医学伦理学,2020,33(1):39-43.
[14] 周吉银,刘丹,曾圣雅,等.我国国家食品药品管理总局加入ICH-GCP对伦理委员会的要求[J].中国医学伦理学,2017,30(12):1512-1516.
[15] 吴爵,孙云,蒋辉.影响伦理审查工作独立性的因素及对策分析[J].中国医学伦理学,2019,32(11):1383-1387.
[16] 王晓虎,吴三兵,刘鹏程,等.医疗机构伦理委员会伦理审查困境及对策研究[J].锦州医科大学学报:社会科学版,2019,17(3):29-31.
[17] 谢洁琼,余中光,陆麒,等.我国药物临床试验伦理审查能力的调查研究[J].中国医学伦理学,2019,32(2):213-216.
[18] 王佳楠,钱雪,李见明.药物临床试验数据核查工作及常见问题分析[J].中国新药杂志,2018,27(11):1273-1276.
[19] Code of Federal Regulations (CFR)[EB/OL].(2018-03-22)[2020-03-07]. https://www.fda.gov/medical-devices/overview-device-regulation/code-federal-regulations-cfr.
[20] 安丽娜.我国伦理委员会的变迁、现状与监管研究[J].山东科技大学学报:社会科学版,2019,21(3):26-32.
[21] 李久辉,徐静香,陈晓云,等.法国《生命伦理法》立法之路及其伦理学思考[J].中国医学伦理学,2013,26(4):517-519.
[22] 祝丹娜,吉萍,许卫卫,等.临床科研项目伦理审查的挑战与对策——以深圳市各医疗机构伦理委员会为例[J].中国医学伦理学,2020,33(1):52-55.
[23] 田冬霞.中美伦理审查委员会管理机制之比较与分析[J].中国卫生事业管理,2009,26(9):642-644.
[24] 朱琳.西方伦理委员会监管对我国的启示[J].西部中医药,2017,30(3):72-74. |
|
|
|