The Journal of KAIRB (대한기관윤리심의기구협의회지)

Korean Association of Institutional Review Boartds (대한기관윤리심의기구협의회)
권호 표지

Analysis and Ethical Review of the Compensation System for Clinical Trial Injury in India

인도 임상시험 피해보상제도 분석 및 윤리적 고찰

  • Lee, Chan Joo (Department of Institutional Review and Research Ethics, Nicholas Cardinal Cheong Graduate School for Life, The Catholic University of Korea) ;
  • Choe, Byung In (Department of Institutional Review and Research Ethics, Nicholas Cardinal Cheong Graduate School for Life, The Catholic University of Korea)
  • 이찬주 (가톨릭대학교 생명대학원 임상연구윤리학과) ;
  • 최병인 (가톨릭대학교 생명대학원 임상연구윤리학과)
  • Received : 2021.01.18
  • Accepted : 2021.02.17
  • Published : 2021.02.26
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Abstract

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.

Keywords

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