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Acoustic Separation and Biomedical Research: Lessons from Indian Regulation of Compensation for Research Injury

Published online by Cambridge University Press:  01 January 2021

Megan E. Larkin
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Extract

In early 2013, the Indian Central Drugs Standard Control Organisation, under supervision of the Health Secretary, introduced new rules governing the conduct of clinical trials involving human participants. Among other provisions, the rules require that sponsors of research compensate participants who are injured during the course of their research participation. The rules presumably were drafted to protect citizens from harm caused by biomedical research without unduly restricting access to the benefits that research can provide. While requiring compensation for injury is widely-acknowledged as a critical component of ensuring ethical conduct of human subjects research, in this case the legal restrictions do not match the ethical justifications that support a compensation requirement. To see this, it is important to examine the context in which the rules were written, the justifications for rules of this type, and what mechanisms are available to bring the effects of the rules into alignment with the norms their passage sought to promote.

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 43 , Issue 1 , Spring 2015 , pp. 105 - 115
Copyright
Copyright © American Society of Law, Medicine and Ethics 2015

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For example, in the past, India's research industry has faced robust criticism over non-payment to individuals who were injured or killed due to participation in biomedical research. Reporting on the mechanism of compensation was less developed than reporting on the fact of injury and non-payment. See, e.g., India, “Only 45 of 2,868 Clinical Trial Deaths Compensated since 2005,” supra note 9.Google Scholar
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