心理社会干预随机对照试验研究人员的伦理实践

Ethical Practice in Randomized Controlled Trials of Psychosocial Intervention:Results of an International Researcher Survey

目的:考察研究者执行心理社会干预随机对照试验时的伦理实践现状。方法:采用24个条目的自编问卷调查了62名国内外从事心理社会干预随机对照试验的研究人员的伦理实践情况,并询问与伦理审查、伦理冲突有关的开放性问题。结果:研究人员普遍重视将干预的伤害最小化,但难以做到充分的知情同意。在设计对照组时也会遭遇伦理冲突。非参数检验显示国外研究人员比国内研究人员更重视被试的福祉(Ps<0.05)。结论:需加强对国内科研工作者的伦理培训,严格伦理审查。

Objective:To investigate the ethical practices of researchers in conducting randomized controlled trials(RCT)of psychosocial interventions.Methods:We measured the ethical practice of 62 international researchers through a24-item self-developed questionnaire.We also asked researchers a few open-ended questions about their experiences with the Institutional Review Board(IRB)and their perceived ethical conflicts during RCT.Results:Researchers performed well in avoiding harm to participants but were poor at informing participants of the potential risks of intervention and the differences between RCT and psychotherapy.Researchers often had ethical conflicts in designing control groups.Non-parametric tests showed that researchers who conducted RCT in foreign countries performed better in protecting the welfare of participants than those in China(Ps<0.05).Conclusion:It is necessary to provide more ethical training for Chinese researchers.IRB also needs to scrutinize RCT more rigorously.