我国区域伦理委员会的前生、今世和来生
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摘要
目的概述我国区域伦理委员会的发展史,结合当前国家政策法规展望未来发展趋势。方法查阅国内有关区域伦理委员会的文献并结合国家政策法规阐述其发展脉络。结果我国区域伦理委员会是在国家创新药物发展需求下正式提出,各地区正不断成立,其功能可定位在审查、培训等方面。具有独立公正和高效审查的优点,需明确职责和审查范围、受主管部门监管、高标准选择委员、强化审查和事务性管理、接受认证评估、加强信息化建设以保证审查质量和效率。结论我国区域伦理委员会是应时之需,未来需不断探索其功能定位,针对性采取措施解决存在的问题,补充性提升我国伦理审查水平。
Objective: To summarize the development history of regional ethics committee in China,and look forward to the future development trend in combination with current national policies and regulations. Methods:This paper looked up domestic literatures about regional ethics committee and expounded its development context combining with national policies and regulations. Results: Regional ethics committee of our country was formally put forward under the demand for the development of innovative drugs in the country,various regions were continuously established,and their functions could be located in aspects of review and training. It had the advantages of independence,fairness,and efficient review,and it needed to clarify responsibilities and the scope of review,be supervised by competent department,select members with high standard,strengthen review and transactional management,accept certification assessment and strengthen information construction,so as to ensure the quality and efficiency of review. Conclusion: Regional ethics committee in China is the need of the times,and it needs to constantly explore its function and orientation,take targeted measures to solve existing problems and complementarily improve the level of Chinese ethical review in the future.
Objective: To summarize the development history of regional ethics committee in China,and look forward to the future development trend in combination with current national policies and regulations. Methods:This paper looked up domestic literatures about regional ethics committee and expounded its development context combining with national policies and regulations. Results: Regional ethics committee of our country was formally put forward under the demand for the development of innovative drugs in the country,various regions were continuously established,and their functions could be located in aspects of review and training. It had the advantages of independence,fairness,and efficient review,and it needed to clarify responsibilities and the scope of review,be supervised by competent department,select members with high standard,strengthen review and transactional management,accept certification assessment and strengthen information construction,so as to ensure the quality and efficiency of review. Conclusion: Regional ethics committee in China is the need of the times,and it needs to constantly explore its function and orientation,take targeted measures to solve existing problems and complementarily improve the level of Chinese ethical review in the future.
引文
[1]周吉银,邓璠,刘丹,等.我国医学伦理委员会存在的问题及建议[J].中国临床药理学杂志,2017,33(4):87-90.
[2]Brower RG,Bernard G,Morris A.Ethics and standard of care in clinical trials[J].Am J Respir Crit Care Med,2004,170(2):198-199.
[3]凌丽,吕祥,夏英,等.关于中医药临床研究伦理审查平台建设评估的思考[J].中国医学伦理学,2013,26(4):520-521.
[4]胡庆澧,沈铭贤.努力提高多中心临床研究的伦理审查质量[J].医学与哲学(人文社会医学版),2011,32(9):2-5.
[5]中华人民共和国国家卫生和计划生育委员会.涉及人的生物医学研究伦理审查办法[J].中华人民共和国国家卫生和计划生育委员会公报,2016(10):1-7.
[6]陈旻.确保伦理审查质量与提高效率之间的平衡[J].中国医学伦理学,2017,30(12):1447-1448.
[7]国务院.国务院关于改革药品医疗器械审评审批制度的意见[J].中国药物评价,2016,33(2):65-67.
[2]Brower RG,Bernard G,Morris A.Ethics and standard of care in clinical trials[J].Am J Respir Crit Care Med,2004,170(2):198-199.
[3]凌丽,吕祥,夏英,等.关于中医药临床研究伦理审查平台建设评估的思考[J].中国医学伦理学,2013,26(4):520-521.
[4]胡庆澧,沈铭贤.努力提高多中心临床研究的伦理审查质量[J].医学与哲学(人文社会医学版),2011,32(9):2-5.
[5]中华人民共和国国家卫生和计划生育委员会.涉及人的生物医学研究伦理审查办法[J].中华人民共和国国家卫生和计划生育委员会公报,2016(10):1-7.
[6]陈旻.确保伦理审查质量与提高效率之间的平衡[J].中国医学伦理学,2017,30(12):1447-1448.
[7]国务院.国务院关于改革药品医疗器械审评审批制度的意见[J].中国药物评价,2016,33(2):65-67.