Nature and history of the CIOMS International Ethical Guidelines and implications for local implementation: A perspective from East Africa
Nature and history of the CIOMS International Ethical Guidelines and implications for local implementation: A perspective from East Africa
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DOI：
10.1111/dewb.12249
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发表时间：
2019-10-23
影响因子：
2.2
通讯作者：
Kutyabami, Paul
中科院分区：
文献类型：
--
作者：
Barugahare, John;Kutyabami, Paul
乌干达国家科学技术委员会组织的第十届年度研究伦理会议（2018）的主题是“乌干达及该地区研究伦理的演变：过去、现在和未来”。我们被要求讨论的主题是：“CIOMS 的历史和国际道德准则的最新变化：对当地研究的影响”。会议的主旨是跟踪确保研究道德行为的进展，强调遇到的挑战，并提出在当地情况下有效和有意义地实施国际道德准则的策略。因此，本文的目的是评论 CIOMS 道德准则历史的影响，并提出在东非地区乃至整个撒哈拉以南非洲有效且有意义地实施这些准则的策略。根据 CIOMS 指南的“演进性”、“灵活性”和“一般性”性质，我们提出了六点策略，以确保其在当地环境中有效且有意义的实施。该战略以当地研究监管机构和研究人员的义务为形式，履行这些义务将对其在当地的顺利和有意义的实施大有帮助。这些义务是： 确保每项指南均以证据为基础进行调整；确保 REC 成员足够明智和积极主动；积极采取行动，确保生物伦理学与当地法律制度之间的和谐；在公众中培养“生命伦理文化”；迈向区域生物伦理治理；并在这些指南的未来修订中发挥积极和有意义的作用。
The theme of the 10(th) Annual Research Ethics Conference organized by the Uganda National Council for Science and Technology (2018) was "Evolution of Research Ethics in Uganda and the Region: Past, Present and Future". We were asked to address the topic: "The History of CIOMS and the recent changes in the international ethics guidelines: implications for local research". The thrust of the conference was to track progress in ensuring ethical conduct of research, highlight challenges encountered, and to propose strategies for effective and meaningful implementation of international ethical guidelines in local contexts. Consequently, the purpose of this paper is to comment on the implications of the history of CIOMS ethical guidelines and suggest strategies for their effective and meaningful implementation in the East African region, and perhaps the whole of Sub-Saharan Africa. Inferring from the 'evolutionary', 'flexible', and 'general' nature of the CIOMS guidelines, we proposed a six-point strategy for ensuring their effective and meaningful implementation in local contexts. This strategy is in the form of obligations for local research regulators and researchers, the fulfillment of which will go a long way towards their smooth and meaningful implementation in local contexts. These obligations are: ensuring evidence-based adaptation of each individual guideline; ensuring sufficiently judicious and motivated RECs membership; acting proactively to ensure harmony between bioethics and local legal regimes; cultivating a 'bioethics culture' among the public; moving towards regional bioethics governance; and playing an active and meaningful role in future revisions of these guidelines.