Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks.
Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks.
复制标题
对政府卫生项目的随机评估确实对标准研究伦理框架提出了挑战。
DOI：
10.1136/medethics-2019-106003
复制
发表时间：
2020
影响因子：
4.1
通讯作者：
Watson SI
中科院分区：
文献类型：
--
作者：
Watson SI
在最近一期的《医学伦理学杂志》（JME）中，我们讨论了对干预措施进行评估的伦理审查，无论评估是否进行。我们的结论是，标准的研究伦理框架，包括渥太华声明，这需要合理的干预和推出的各个方面，是一个穷人在这方面的指导。我们建议，考虑研究者的责任，根据研究发生的后果，将是一个更合适的方式划定研究伦理审查的范围。Weijer和Taljaard提出了一个反驳我们的建议，我们在这个答复中解决。他们声称，对研究人员责任的关注将削弱对研究参与者的保护，并将其与“不道德的研究”和“政府在自己的人民身上进行实验”联系起来。然而，研究人员的道德责任是根据研究对人类福利和伤害的后果来定义的，而不是与之相反。魏杰和塔尔雅德认为，研究人员必须证明他们正在研究的东西是合理的，无论他们是否对它有任何控制权，政府必须证明他们的计划是合理的，包括通过展示平衡，如果他们以随机的方式实施这些计划，就必须向研究伦理委员会证明。我们强烈反对这是一种定义研究伦理审查范围的可辩护方式，并认为这没有为研究参与者提供超出我们建议的进一步保护，而是为从政府项目中学习设置了潜在障碍。
In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to ‘unethical research’ and a ‘government experimenting on its own people’. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes.