摘要
伦理审查委员会在审查工作中存在一些问题,主要有:伦理审查时机的问题,是在项目申报之前进行伦理审查,还是在项目批准后进行伦理审查?关于受益和风险的评估问题,人们普遍感到受益和风险的评估并不那么容易;伦理审查的独立性问题。针对这些问题,应该积极主动地改进伦理审查委员会的工作,加强对受试者的保护;同时,建立SOP(标准操作程序),以期改进工作质量;还应重视教育和培训的作用。伦理审查委员会的工作还需要高水平的智慧和相对的独立性。
Certain problems exist in the review work of ethics review committee. Whether the review work shouId be launched before the project application or after its being approved＇？. It remains a tough issue to assess the profit/risk ratio of an ethics involved project. The independence of ethics review plays a crucial role in carrying out the review work of ethics review committee. All of the above issues should be taken into consideration in order to positively improve the review work of ethics review committee, and strengthen the protection for the legal rights of research subjects. Meanwhile, a SOP of ethics review is expected to be established to improve the current review quality. Ceratin education and training should also be stressed whose significance has reached a consensus. Extradinary wisdom and political independence are also needed in the review work.
出处
《中国医学伦理学》
2011年第1期3-5,26,共4页
Chinese Medical Ethics
