Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa
Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa
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DOI：
10.1186/s12910-018-0244-y
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发表时间：
2018-02-17
影响因子：
2.7
通讯作者：
Moodley, Keymanthri
中科院分区：
文献类型：
--
作者：
Chingarande, George Rugare;Moodley, Keymanthri
背景资料：研究相关伤害的赔偿是一个主题，这是越来越多的牵引力在发展中国家的多中心研究的新兴目的地。然而，不同的补偿规则的存在违反了公平的伦理原则。目前的文件提出了一个比较的政策，巴西，俄罗斯，印度，中国和南非（BRICS）。方法：进行了系统的搜索良好的临床实践指南，采用搜索策略建模符合ADPTE协作（2007年）的建议。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受限互联网检索。还对相关指南文件中引用的参考文献进行了手动检索。检索词、医学主题词（MeSH）和关键词是为PubMed平台开发的，然后适用于所有其他数据库。每个国家的搜索词保持不变，唯一的区别是国家名称。结果：研究表明，存在着大量的法规，这些法规存在于一个连续体上。一个极端是印度，其全面的法规被编入法律，另一端是中国，其没有具体的法律来规范与研究相关的伤害。有一些差异和相似之处，如强制性保险要求，存在无过错赔偿，可赔偿的伤害和研究伦理committees.Conclusions的作用：它是必要的立法，保护参与者，而不扼杀研究企业。需要在全球一级使这些条例保持一致，最好是协调一致。研究相关伤害赔偿的示范政策应借鉴不同国家政策的最佳方面，并应遵循自主、公正和有益的基本伦理原则。
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.