Child and Newborn Health Group, Kemri-Wellcome Trust Research Programme, PO Box 43640, Nairobi, Kenya.
BMC Med Ethics. 2011 Nov 15;12:22. doi: 10.1186/1472-6939-12-22.
Promoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within academic bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.
We reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.
Access to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.
Although in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context.
在资源匮乏的环境中开展全球卫生研究的社会价值已成为全球研究伦理的一个关键关注点。利益共享的考虑,即阐明参与者、他们的社区和参与此类研究的东道国应得到什么,如果有任何回报,以及研究人员的义务,是促进研究社会价值的主要策略之一。然而,在过去的十年中,学术生物伦理学文献中就利益的定义、受益者以及提供这些利益的义务范围展开了激烈的辩论。尽管这一辩论可能表明国际层面愿意参与到全球卫生研究中所涉及的研究人员的责任,但仍不清楚应该考虑哪些形式的利益或受益者。本文审查了国际和当地的研究伦理准则,以阐明它们提供的指导。
我们审查了美国卫生与公众服务部人类研究保护办公室(Office for Human Research Protections)从国际研究伦理准则汇编中选择的文件。
通常推荐的利益形式包括获得正在研究的干预措施、提供无法获得的医疗保健、为个人和机构建设能力、支持医疗保健系统以及获得已证明有效的医疗和公共卫生干预措施。受益者是志愿者、受疾病或疾病影响的社区以及一般人群。然而,有趣的是,在资源匮乏环境中,“全球观点”与特定国家的观点之间存在分歧,这体现在对潜在利益和受益者的重视程度存在差异上。
尽管从理论上讲,利益共享被广泛认为是促进国际合作卫生研究社会价值的手段之一,但主要准则之间在研究人员在促进研究社会价值方面的具体责任方面存在较少的共识。缺乏共识可能会对旨在增强资源匮乏环境中开展的全球卫生研究的社会价值的努力产生实际影响。全球研究伦理的进一步发展需要更多的反思,关注在现实世界背景下实施伦理原则的实际情况。