Compensation to Clinical Trial Participants in India: A Gap Analysis

  • Mohd Urooj Department of Pharmacology, Central Research Institute of Unani Medicine, Under CCRUM, Ministry of AYUSH Government of India, Hyderabad, Telangana, India
  • Gulam Mohammed Husain Department of Pharmacology, Central Research Institute of Unani Medicine, Under CCRUM, Ministry of AYUSH Government of India, Hyderabad, Telangana, India
  • Mohammad Ahmed Khan Department of Pharmacology, Central Research Institute of Unani Medicine, Under CCRUM, Ministry of AYUSH Government of India, Hyderabad, Telangana, India
  • Munawwar Husain Kazmi Department of Pharmacology, Central Research Institute of Unani Medicine, Under CCRUM, Ministry of AYUSH Government of India, Hyderabad, Telangana, India
Keywords: Adverse event, Ethics, Injury/death

Abstract

The recent amendments notified by the Government of India, for conducting clinical trial, is greatly appreciable as promoting safety and well-being of human subjects. These rules clearly state that medical management of injuries in clinical trials is mandatory and clinical trial-related injury or death needs to be compensated over and above the medical management. These rules need to be reconsidered for simplification and better understanding of issues regarding compensation. There is a need of clarity at some points which should be discussed with all stakeholders for better understanding of current regulations. In our view, attention must also be given to academic investigators, during discussion to promote availability of cost-effective treatment in India.

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B = Base amount (i.e., 8 lakhs). F = Factor depending on the age of the participant (based on Workmen’s Compensation Act). R = Risk factor depending on the seriousness and severity of the disease, presence of comorbidity, and duration of disease of the participant at the time of enrollment in the clinical trial between a scale of 0.5 and 4 as under:
Published
2017-07-24
How to Cite
1.
Urooj M, Husain GM, Khan MA, Kazmi MH. Compensation to Clinical Trial Participants in India: A Gap Analysis. ijpi [Internet]. 24Jul.2017 [cited 28Sep.2022];7(2):41-6. Available from: https://www.jpionline.org/index.php/ijpi/article/view/177