Partnership as an ethical model for medical research in developing countries: the example of the "implementation trial''
Partnership as an ethical model for medical research in developing countries: the example of the "implementation trial''
复制标题
DOI：
10.1136/jme.2005.012955
复制
发表时间：
2006-06-01
影响因子：
4.1
通讯作者：
Dowdy, D. W.
中科院分区：
文献类型：
--
作者：
Dowdy, D. W.
现有的医学研究伦理审查模式主要包括旨在防止参与者受到剥削的法规。当审查其他道德义务时，特别是向社会提供有价值的知识的责任时，这种模式可能会失败。这种失败在发展中国家最为明显，因为许多利益相关者缺乏维护社会利益的动力或权力。另一种道德模式是伙伴关系，它积极让所有合作伙伴参与道德审查，旨在通过妥协确保合作伙伴的最大利益。与现有的“监管”模式不同，合伙模式有效地解决了道德义务，为社会提供积极的利益。为了使合伙模式有效，合伙人之间必须共享权力；因此，通过明确考虑权力结构，合伙模式可以与“监管”模式协调一致。在发展中国家制定权力平衡的一个机会是显而易见的，即由长期公共卫生干预措施的实施所推动并纳入其中的“实施试验”随机试验。鉴于现有伦理审查模式的失败，必须探索替代模式（例如伙伴关系）和平衡权力的手段（例如实施试验），以确保医学研究为发展中国家的社会提供有价值的知识。
The existing model for ethical review of medical research consists primarily of regulations designed to prevent exploitation of participants. This model may fail when reviewing other ethical obligations, particularly the responsibility to provide valuable knowledge to society. Such failure is most apparent in developing countries, in which many stakeholders lack incentives or power to uphold society's interests. An alternative ethical model is that of partnership, which actively involves all partners during ethical review and aims to secure partners' best interests through compromise. Unlike the existing "regulatory'' model, the partnership model effectively addresses ethical obligations to provide positive benefits to society. For the partnership model to be effective, power must be shared among partners; thus, the partnership model can be harmonised with the "regulatory'' model through explicit consideration of power structures. One opportunity for crafting power balance in developing countries is apparent in "implementation trials'' randomised trials motivated by and integrated into the implementation of long term public health interventions. Given the failings of the existing ethical review model, alternative models - for example, partnership - and means to balance power - for example, implementation trials - must be explored to ensure that medical research provides knowledge of value to societies in the developing world.