How Civil Society Organisations Changed the Regulation of Clinical Trials in India.
How Civil Society Organisations Changed the Regulation of Clinical Trials in India.
复制标题
民间社会组织如何改变印度临床试验的监管。
DOI：
10.1080/09505431.2018.1493449
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发表时间：
2019
影响因子：
2.6
通讯作者：
Sariola S
中科院分区：
文献类型：
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作者：
Sariola S
2005年，印度改变了其制药和创新政策，促进了涉及印度研究地点的国际临床试验的急剧增加。这一政策转变引发了争议;民间社会组织（CSO）批评印度政府促进医药研发的商业化。印度的卫生社会运动通过集体行动为社会正义而战，并对研究的利益、负担和平等进行规范性推理。他们游说保护审判参与者免受结构性暴力，特别是在新政策的前5-6年。2013年，民间社会组织在引入新法规方面发挥了重要作用，这加速了在印度进行的全球试验数量的下降。这种行动主义将全球社会正义的解释作为动员的关键思想，最终有助于在国家层面上将更严格的道德监管制度化。与政府和工业界一样，活动家们相信随机对照试验和比较是科学知识生产的关键方法。然而，他们对商业制药研究的全球等级制度及其对参与者权利和印度整体利益的影响表示严重关切。他们指出了道德上的不当行为，并游说制定更严格的道德法规，旨在确保研究参与者的公正，并制定了有效的战略来加强对临床研究商业方面的控制。
In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5–6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.