跨国试验时代针对研究相关损伤的不同补偿政策：以巴西、俄罗斯、印度、中国和南非为例的研究
Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa.
作者信息
Chingarande George Rugare, Moodley Keymanthri
机构信息
Centre for Medical Ethics and Law, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, PO Box 241, Cape Town, 8000, South Africa.
出版信息
BMC Med Ethics. 2018 Feb 17;19(1):8. doi: 10.1186/s12910-018-0244-y.
BACKGROUND
Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa (BRICS).
METHODS
A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration (2007). The search focused on three main areas namely bibliographic data bases, clinical practice guidelines data bases and a restricted internet search. A manual search of references cited in relevant guideline documents was also conducted. The search terms, Medical Subject Headings (MeSH) and key words were developed for a PubMed platform and then adapted for all other data bases. The search terms were kept constant for each country with the only difference being the country name. The documents so obtained were subjected to systematic content analysis.
RESULTS
The study revealed that there is vast panoply of regulations which exist on a continuum. On one extreme is India with comprehensive regulations that are codified into law, and on the other end there is China which does not have specific laws regulating research related injuries. There are a number of differences and similarities such as mandatory insurance requirements, existence of no fault compensation, compensable injuries and the role of research ethics committees.
CONCLUSIONS
It is imperative to enact legislations that protect participants without stifling the research enterprise. There is need for consistency and ideally harmonization of such regulations at a global level. A model policy on compensation for research related injuries should borrow from the best aspects of the different country policies and should be informed by the cardinal ethics principles of autonomy, justice and beneficence.
背景
在正迅速成为多中心研究热门目的地的发展中国家，对研究相关损伤的补偿问题日益受到关注。然而，不同的补偿规则违反了公平的伦理原则。本文对巴西、俄罗斯、印度、中国和南非（金砖国家）的政策进行了比较。
方法
采用符合ADPTE协作组织（2007年）建议的检索策略，对良好临床实践指南进行系统检索。检索集中在三个主要领域，即书目数据库、临床实践指南数据库和有限的互联网检索。还对手动检索相关指南文件中引用的参考文献进行了检索。为PubMed平台制定了检索词、医学主题词（MeSH）和关键词，然后对所有其他数据库进行了调整。每个国家的检索词保持不变，唯一的区别是国家名称。对所获得的文件进行系统的内容分析。
结果
研究表明，存在大量连续的法规。一端是印度，其全面的法规已编纂成法律；另一端是中国，没有专门规范研究相关损伤的法律。在强制保险要求、无过错补偿的存在、可补偿损伤以及研究伦理委员会的作用等方面存在许多差异和相似之处。
结论
必须制定保护参与者的立法，同时又不扼杀研究事业。需要在全球层面保持此类法规的一致性，理想情况下实现协调统一。关于研究相关损伤补偿的示范政策应借鉴不同国家政策的最佳方面，并应以自主、公正和行善等基本伦理原则为依据。
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