Implications of the compensation rule of India

What is it about?

Indian rule on compensation for any injury or death of the subject in a clinical trial is based on the causality assessment. However, it ignores the scientific basis of causality assessment. There is a need to bring clarity on causality assessment process within the compensation rules to balance the ethical need of human subject protection and the scientific requirements of safety assessment. This article reviews some of the implications of the compensation rule on causality assessment.

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Why is it important?

The compensation, in a clinical trial setting, reflects three important issues - morality, causality and legality. The morality emphasizes the right of a clinical trial participant for compensation in case of a serious adverse event (SAE) due to an investigational product (IP). The causality establishes the relationship between an SAE and IP. And the legality prescribes the legal framework for paying compensation in such cases. Thus the compensation rule, whilst trying to support the morality of human subject protection, could have far reaching consequences on (1) science of causality assessment and (2) safety assessment of a new drug under clinical development.