Closing the translation gap for justice requirements in international research
Closing the translation gap for justice requirements in international research
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DOI：
10.1136/medethics-2011-100301
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发表时间：
2012-09-01
影响因子：
4.1
通讯作者：
Loff, Bebe
中科院分区：
文献类型：
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作者：
Pratt, Bridget;Zion, Deborah;Loff, Bebe
生物伦理学家长期以来一直在争论国际临床研究中赞助者和研究者的公正义务的内容。然而，对于在低收入和中等收入国家环境中是否以及如何坚持响应、辅助护理、审判后福利和加强研究能力的义务，几乎没有进行过实证调查。在本文中，作者认为，研究伦理准则需要更多地了解国际研究实践。如果研究小组和其他行为者要成功地将这些义务转化为实践，就需要关于如何履行这些义务的实用指导，因为这样做往往是一个复杂的、针对具体情况的过程。案例研究方法为收集数据以制定这一指南提供了一种途径。作者描述了这些方法如何用于Shoklo疟疾研究单位的间日疟治疗（VHX）试验（NCT 01074905）。本文以VHX试验为例，展示了如何从国际临床研究者、试验参与者、社区咨询委员会成员和研究资助者代表那里收集信息，以便：（1）衡量国际临床研究中的反应性证据、辅助治疗的提供、试验后获益的获得和研究能力的加强;以及（2）确定有助于履行这些道德义务的背景因素、角色和责任。这种经验性工作对于在国际研究中阐明司法义务和制定关于如何履行这些义务的指导意见是必要的，以便促进更好地遵守准则的要求。
Bioethicists have long debated the content of sponsors and researchers' obligations of justice in international clinical research. However, there has been little empirical investigation as to whether and how obligations of responsiveness, ancillary care, post-trial benefits and research capacity strengthening are upheld in low-and middle-income country settings. In this paper, the authors argue that research ethics guidelines need to be more informed by international research practice. Practical guidance on how to fulfil these obligations is needed if research groups and other actors are to successfully translate them into practice because doing so is often a complicated, context-specific process. Case study research methods offer one avenue for collecting data to develop this guidance. The authors describe how such methods have been used in relation to the Shoklo Malaria Research Unit's vivax malaria treatment (VHX) trial (NCT01074905). Relying on the VHX trial example, the paper shows how information can be gathered from not only international clinical researchers but also trial participants, community advisory board members and research funder representatives in order to: (1) measure evidence of responsiveness, provision of ancillary care, access to post-trial benefits and research capacity strengthening in international clinical research; and (2) identify the contextual factors and roles and responsibilities that were instrumental in the fulfilment of these ethical obligations. Such empirical work is necessary to inform the articulation of obligations of justice in international research and to develop guidance on how to fulfil them in order to facilitate better adherence to guidelines' requirements.