The 2016 CIOMS guidelines and public-health research ethics
The 2016 CIOMS guidelines and public-health research ethics
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DOI：
10.7196/sajbl.2017.v10i2.00605
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发表时间：
2017-12-01
影响因子：
0.9
通讯作者：
Williams, J. R.
中科院分区：
文献类型：
--
作者：
Williams, J. R.
2016年11月，国际医学科学组织理事会（CIOMS）发布了经修订的《涉及人体健康的研究国际伦理准则》。与早期版本相比，新准则的范围已扩大到包括公共卫生研究。虽然该文件在某种程度上是成功的，但它没有充分考虑到公共卫生研究与其他类型的卫生研究之间的差异。它对公共卫生研究的一些重要问题保持沉默，例如公共卫生的定义、卫生不平等和新的研究方法。它对其他一些问题的处理，包括需要研究伦理委员会的批准、同意、社区参与和研究结果的传播，在某些方面存在缺陷。特别适用于和对公共卫生研究有用的准则涉及社会价值、社区和人口的卫生需求、社区参与、灾害和疾病暴发、聚类随机试验和数据共享。需要进一步发展公共卫生研究伦理的基础和应用，以便为今后修订准则和其他国际和国家研究伦理文件提供信息。
In November 2016, the Council for International Organizations of Medical Sciences (CIOMS) published its revised International Ethical Guidelines for Health-related Research Involving Humans. In relation to earlier versions, the scope of the new guidelines has been expanded to include public-health research. While successful to some extent, the document does not take into sufficient account the differences between public-health research and other types of health research. It is silent on some issues of importance to public-health research, such as its definition, health inequities and novel research methodologies. Its treatment of some other issues, including the need for research-ethics committee approval, consent, community involvement and dissemination of research results, are deficient in some respects. The guidelines that are particularly applicable to and useful for public-health research deal with social value, the health needs of communities and populations, community engagement, disasters and disease outbreaks, cluster randomised trials and data sharing. Much further development of the foundations and applications of public-health research ethics is needed to inform future revisions of the guidelines and of other international and national research-ethics documents.