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Pages: 141-147

Date of Publication: 14-Jun-2022

Compensation for clinical trial participants in India: A regulatory overview

Author: Tanushka, Mandeep Kaur, Sourabh Kosey, Shikha Sharma

Category: Pharmaceutics

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Abstract:

Clinical research is the branch of health-care science which deals with safety and efficacy of medications, devices, diagnostic test, and treatment regimen in human. Good clinical practice (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. An expert committee set up by Central Drugs Standard Control Organization (CDSCO) in consultation with a clinical expert has formulated this GCP guideline for generation of clinical data on drugs. The drug technical advisory board, the highest technical body under D and C, act, has endorsed adoption of this GCP guideline for streamlining the clinical studies in India. The new drug regulatory processes come under the drug controller general of India who is head of CDSCO. Schedule Y has three major section and 11 appendices that are an application for permission, clinical trial, and studies in special population compensation in clinical trials which means participants receive monetary or other benefits for their participation (suffer and harm) in the clinical trial. Compensation is more common in phase 1 trials with healthy volunteers and is usually paid to participants. Some cases compensation is not paid to participants depend on the sponsor and the study design. Many clinical research organizations even advertise participation in clinical studies as it offers a (limited) possibility to earn money. Compensation is always a special concern with vulnerable populations, particularly in children and people with intellectual or mental disabilities. People in these vulnerable populations do not or cannot make their own decisions. Compensation amount will vary from a minimum of Rs. 8 lakhs to a maximum of Rs. 73.60 lakhs depending on the age of the deceased and the risk factor.

Keywords: Clinical research, Central Drugs Standard Control Organization, Drug controller general of India, good clinical practice

References:

1. Schedule Y. Drug and Cosmetics Act. New Delhi: CDSCO; 2014.

2. Chow SC, Liu JP. Design and Analysis of Clinical Trials. NewYork: John Wiley and Sons; 2004.

3. Singh H, Pandey A, Gautam SS, Gautam CS. Compensation in Clinical Trials: Indian Scenario; Recent Advences in Clinical Trials. Raipur: Twenty First Century Publication; 2017. p. 28-39.

4. Times Nation. The Time of India Mumbai. Mumbai: Times Nation; 2011. p. 14.

5. Sheldon RA. Green Solvents for sustainable organic synthesis: State of the art. Green Chem 2005;7:267-78.

6. Clark JH, Luque R, Matharu AS. Green chemistry, biofuels, and biorefinery. Annu Rev Chem Biomol Eng 2012;3:183-207.

7. Ahluwalia VK, Kidwai M. New Trends in Green Chemistry. New Delhi: Anamaya Publishers; 2004. p. 16.

8. Anastas PT, Horvath IT. Innovations and green chemistry. Chem Rev 2007;107:2169.

9. Mandal J, Acharya S, Parija SC. Ethics in Human Research, Trop Parasitol. United States: NCBI; 2011.

10. Jigneeshu D, Abhidnya D, Pramesh CS, Mohandas KM, Sudeep G, Rajendra B. Compensation guideline for research related injury in India. JAssoc Phys India 2012;60:53-5.

11. Charles RH, Montgomery JA. The book of Daniel. A Critical and Exegetical Commentary on the Book of Daniel. Sacramento: Creative Media Partners, LLC; 2018. p. 220-3, 247-9.

12. The Editors of Encyclopaedia Britannica. Tuskegee Syphilis Study. Amy Tikkanen. Available from: https://www.britannica.com/event/Tuskegeesyphilis-study.

13. Ministry Gets 2 Months to Define Clinical Trials Regulatory Regime, Livemint; 2013. Available from: http://www.livemint.com/Industry/ JTitha6MKC0Q1UdZToidFK/Ministry-gets-2-months-to-define-clinicaltrials-regulatory.html. [Last accessed on 2013 Jan 24].

14. Available from: https://www.lawctopus.com/academike/article-21-of-theconstitution-of-india-right-to-life-and-personal-liberty. [Last accessed on 2015 Jan 13].

15. “Illegal Clinical Trials Must Be Stayed”, The Hindu; 2013. Available from: http://www.thehindu.com/news/national/illegal-clinical-trials-creatinghavoc-supreme-court/article4268671.ece. [Last accessed on 2013 Jan 24].

16. Article 21-A Strive toward Human Well Being. Available from: http://www. lawyersclubindia.com/articles/print_this_page.asp?article_id=2799. [Last accessed on 2015 Nov 13].

17. Constitutional Law Project-protection of Life and Personal Liberty Article 21 by Ankit Chowdhri. Available from: http://www.scribd.com/doc/52481658/ Article-21-of-the-Constitution-of-India.

18. DCGI Directorate General of Health Services Ministry of Health and Family Welfare offices of Drug Controller General F. No. GCT/20?SC/Cli; 2013. Available from: http://www.cdsco.nic.in/writereaddata/Office%20 Order%20dated%2019.11.2013.pdf. [Last accessed on 2013 Nov 19].

19. Guidelines on Audio-visual Recording of Informed Consent Process in Clinical Trial, Available from: http://www.cdsco.nic.in/writereaddata/Guidance_ for_AV%20Recording_09.January.14.pdf. [Last accessed on 2014 Jan 16].

20. Chauhan CR, Purty JA, Singh N. Audio consent for audio video recording of informed consent process in rural South India. ISCR 2015;6. Available from: http://www.picronline.org/article.asp?issn=22293485;year=2015;volume =6;issue=3;spage=159;epage=162;aulast=Chauhan;type=3.

21. Khan SA. Clinical Trials in India Need Better Regulations, between 2005 and 2012, About 2,800 Patients have Died While Participating in Clinical Trials Conducted by Pharmaceutical Companies. Available from: https:// www.thewire.in/health/clinical-trialsin-india-need-better-regulations. [Last accessed on 2017 Jun 22].

22. Charles RH. The Book of Daniel. United States: Creative Media Partners, LLC; 2018. p. 39. Montgomery JA. A Critical and Exegetical Commentary on the Book of Daniel. New York: Scribner; 1927. p. 220-3, 247-9.

23. Audio-Video Recording of Informed Consent Process of All New Subjects in Clinical Trials. Available from: http://www.cdsco.nic.in/writereaddata/ Office%20Order%20dated%2019.11.2013.pdf. [Last accessed on 2014 Jul 03].

24. Guidelines on Audio-Visual Recording of Informed Consent Process in Clinical Trial. Available from: http://www.cdsco.nic.in/writereaddata/Guidance_ for_AV%20Recording_09.January.14.pdf. [Last accessed on 2014 Jul 06].

25. Audio Visual Recording of Informed Consent is Now Mandatory in India; 2013. Available from: http://www.inclinition.com/manage/pages/ files/1739670688_AV%20Recording%20of%20informed%20consent.pdf. [Last accessed on 2014 Jul 14].

26. Compensation Formula-Formulae to Determine the Quantum of Compensation in the Cases of Clinical Trial Related Serious Adverse Events of Injury Other than Deaths Occurring During Clinical Trials. Available form: http://www.cdsco.nic.in/writereaddata/formula2013SAE.pdf.

27. Draft Formula to Determine the Quantum of Compensation in Case of Clinical Trial Related Injury (Other than Death). Available from: http://www.cdsco. nic.in/writereaddata/uploaded_for_website__1_FINAL2014.pdf. [Last accessed on 2014 May 16].

28. Urooj M, Husain GM, Khan MA, Kazmi MH. Compensation to clinical trial participants in India: A gap analysis. Int J Pharm Investig 2017;7:41-46.

29. Indian Council for Medical Research. Ethical Guidelines for Biomedical Research on Human Participants, ICMR; 2006. Available from: http://www. icmr.nic.in/ethical_guidelines.pdf. [Last cited on 2017 Feb 12].

30. ICMR. ICMR Ethical Guidelines for Biomedical Research on Humans Participants. New Delhi: ICMR; 2006.

31. Formula to Determine the Quantum of Compensation in the Cases of Clinical Trial Related Serious Adverse Event (SAES) of Death Occurring During Clinical Trial. Available form: http://www.kem.edu/wp-content/uploads/2013/08/ Compensation-formula-for-SAEs_2013.pdf.

32. Formula to Determine the Quantum of Compensation in the Cases of Clinical Trial Related Injury (Other than Death). Available form: http://www.cdsco. nic.in/writereaddata/uploaded_for_website__1_FINAL2014.pdf. [Last accessed on 2014 May 16].

33. Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on Human Participants. New Delhi: Indian Council of Medical Research; 2008. Available from: http://www.icmr.nic.in/ethical_guidelines. pdf. [Last accessed on 2012 Mar 26].

34. The Gazette of India. Ministry of Health and Family Welfare. Notification 12th December, G.S.R.889(E). New Delhi: The Gazette of India; 2014.