从受试者保护视角谈研究者的道德责任

Discussion on the moral responsibilities of investigators from the perspective of human subject protection

目的通过探讨研究者在受试者保护中应承担的职责,为探索建构一个基于研究者与伦理委员会密切合作的受试者保护框架提供参考。方法系统分析研究者在研究设计、实施和结题阶段应纳入的受试者保护相关考虑,明确研究者在研究不同阶段应关注的重点伦理问题。结果当前对法规依从性要求的强调,虽然为受试者保护提供了一定的制度保障,但是,不利于研究者在受试者保护中发挥更加主动的作用。结论保护受试者不仅仅是伦理委员会的职责,研究者应当采取更加负责任的态度,主动将受试者保护相关的伦理考虑纳人研究的全过程。

Objective According to the discussion of investigator responsibilities for human subject protection,to provide possible reference for the construction of human subject protection framework calls for more collaboration between investigators and Institutional Review Board(IRB).Methods Systematically analyze the investigator responsibilitievS during the whole process of research including design,implementation and closure,identify key ethical issues that need attention at different stages.Results Currently,the culture of regulatory compliance,though good for the human subject protection from regulatory perspective»is still not optimal for encouraging more innovative protection from investigator perspectives.Conclusions Human subject protection is not only the responsibility of IRBs,investigators should also be more responsible and bring in more ethical considerations in human subject research.