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

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

References

  1. Dan S, Bosea A, Ghosh B, Mandalc P, Pal TK. New Drugs and Clinical Trials Rules-2018 (GSR-104 E) by CDSCO: It's Impact on BA/BE Studies in India. Pharmaceut Reg Aairs 2018;7:1000208.
  2. Ministry of Food and Drug Safety. ICH Korean version of Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2017 [cited 2020 Oct 23]. Available from https://www.nifds.go.kr/brd/m_105/view.do?seq=30603&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=9. Accessed 2020 October 23.
  3. Urooj M, Husain GM, Khan MA, Kazmi MH. Compensation to clinical trial participantsin India: a gap analysis. Int J Pharm Investig 2017;7:41-6. https://doi.org/10.4103/jphi.JPHI_31_17
  4. Mallath MK, Chawla T. Investigators' viewpoint of clinical trialsin India: past, present and future. Perspect Clin Res 2017;8:31-6. https://doi.org/10.4103/2229-3485.198552
  5. Chingarande GR, Moodley K. Disparate compensation policies for research related injury in an era of multinational trials: a case study of Brazil, Russia, India, China and South Africa. BMC Med Ethics 2018;19:8. https://doi.org/10.1186/s12910-018-0244-y
  6. Ravi A. Over 24,000 clinical trial deaths and SAEs in India in ten years [Internet]. The Sunday Guardian Live; 2017 November 5 [cited 2020 Oct 13]. Available from: https://www.sundayguardianlive.com/news/11550-over-24000-clinical-trial-deaths-and-saes-india-tenyears.
  7. National monitoring: illiterate population [Internet]. UNESCO Institute for Statistic; [cited 2020 Dec 24]. Available from: http://data.uis.unesco.org/#.
  8. India releases new draft rulesreinforcing compensation requirements for injuries 'related to' clinical trials [Internet]. Bloomberg Law. Pharmaceutical & Life Sciences News; 2018 [cited 2020 Sep 16]. Available from: https://news.bloomberglaw.com/pharma-and-lifesciences/india-releases-new-draft-rules-reinforcing-compensation-requirements-for-injuries-related-to-clinical-trials.
  9. Extraordinary, Part II- Sec3(i), CHAPTER VI COMPENSATION. Gazette India 2019;161-4, 234-6. Available from https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf. Accessed 2020 Sep 25.
  10. A guide to minimum wage in India [Internet]. India Briefing News. 2020 [cited 2020 Dec 24]. Available from: https://www.india-brieng.com/news/guide-minimum-wage-india-2021-19406.html/.
  11. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (ICMR Guidelines). New Delhi, India: Indian Council of Medical Research; 2017. p. 8-10.
  12. Bioethics and safety act (Eective date 2020 Sep 12) [Internet]. Sejong (Korea): National Law Information Center; 2020 [cited 2020 Feb 3]. Available from: https://www.law.go.kr/LSW/lsInfoP.do?efYd=20200912&lsiSeq=220891#0000.
  13. Pharmaceutical affairs act (Effective date 2020 Oct 08) [internet]. Sejong (Korea): National Law Information Center; 2020 [cited 2020 Feb 3]. Available from: https://www.law.go.kr/LSW/lsSc.do?section=&menuId=1&subMenuId=15&tabMenuId=81&eventGubun=060101&query=%EC%95%BD%EC%82%AC%EB%B2%95#undened.
  14. Rules on the drug safety [Attachment 4] Good Clinical Practice of Drug (Effective date 2020 Oct 14) [Internet]. Sejong (Korea): National Law Information Center; 2020 [cited 2020 Feb 3]. Available from: https://www.law.go.kr/LSW/lsBylInfoP.do?bylSeq=10297391&lsiSeq=220711&efYd=.
  15. Guideline for preparing protocols and procedures for compensation of clinical trial subjects (Complainant's Guide) [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2019 [cited 2020 Feb 3]. Available from: https://www.mfds.go.kr/brd/m_210/view.do?seq=14416.
  16. Gross national income per capital [Internet]. Daejeon (Korea): Korean Statistical Information Service; 2020 [cited 2020 Oct 28]. Available from: https://kosis.kr/statHtml/statHtml.do?orgId=101&tblId=DT_2AS017&conn_path=I2.