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KMID : 1161620210030010001
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Journal of KAIRB
2021 Volume.3 No. 1 p.1 ~ p.10
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Analysis and Ethical Review of the Compensation System for Clinical Trial Injury in India
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Lee Chan-Joo
Choe Byung-In
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Abstract
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In 2004, India began investing in the clinical trial industry; the country now boasts a 20% market share with the help of a valuable resource - the world’s second largest population. The Contract Research Organization has been able to generate profits efficiently conducting clinical trials via a large pool of participants, skilled researchers, and reduced developmental costs. As the demand and sheer number of global clinical trials increased, the International Council of Harmonization-Good Clinical Practice was introduced, and the need for the Institutional Review Board increased. While the clinical trial industry in India boomed, it came at the expense of the participants’ civil rights. The increased media attention regarding the ethical issues forced the Indian Supreme Court to take action. Consequently, India is the only country, by law, that specifically compensates participants suffering from injury directly resulting from participation in clinical trials. This research paper will describe and compare the relevant laws of India and Korea including compensation criteria. In addition, the ethical issues and aspects of indemnity in clinical trials will be discussed. While the clear advantage of the compensation is one of the protected rights of a clinical subject, the current system is not perfect. Furthermore, laws created to redeem ethical issues can have unintended, negative consequences.
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KEYWORD
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Clinical trial, Subject protection, Clinical trial injury, Clinical trial injury compensation, Indian Drugs and Cosmetic Rules
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