Regulating clinical trials in India: The economics of ethics

被引:5
作者
Porter, Gerard [1 ]
机构
[1] Univ Edinburgh, Sch Law, Med Law & Eth, Edinburgh, Midlothian, Scotland
关键词
India; clinical trials; research ethics; regulation; the race to the bottom; COMPENSATION; CONDUCT;
D O I
10.1111/dewb.12156
中图分类号
B82 [伦理学(道德学)];
学科分类号
摘要
The relationship between the ethical standards for the governance of clinical trials and market forces can be complex and problematic. This article uses India as a case study to explore this nexus. From the mid-2000s, India became a popular destination for foreign-sponsored clinical trials. The Indian government had sought to both attract clinical trials and ensure these would be run in line with internationally accepted ethical norms. Reports of controversial medical research, however, triggered debate about the robustness and suitability of India's regulatory system. In response to civil society pressure and interventions by the Supreme Court, the Indian government proposed additional measures aimed at strengthening protections for clinical trial participants. Whilst the reforms can be seen as a victory for human rights activists, they have also been criticised as being overly burdensome for sponsors. Indeed, their announcement prompted an exodus of clinical trials from India. Fearful of losing business to 'rival' countries, the Indian government is revisiting some of its proposals. The Indian example suggests that research ethics frameworks and national policies for economic development are increasingly intertwined. Host countries are in theory free to improve the lot of research participants, but doing so may make them appear less attractive to foreign sponsors, who can simply shift their activities to more industry-friendly jurisdictions. Although these economic pressures are unlikely to lead to a regulatory 'race to the bottom', they may limit host countries' ability to enact socially desirable reforms.
引用
收藏
页码:365 / 374
页数:10
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