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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

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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Copyright © American Society of Law, Medicine and Ethics 2015

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References

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See id., at 383385 Edward L. Rubin has characterized these rules further as being either “transitive” or “intransitive” depending on whether they are merely internal directives aimed at guiding agency action (intransitive) or directly speaking to those who are to be regulated (transitive). If applied to Dan-Cohen's framework, conduct rules may be (or should be) highly transitive – they should pass through the agency and be acted upon by the regulated parties – while decision rules may be highly intransitive because they are intended solely to guide agency conduct. Intransitive rules have higher degrees of acoustic separation, and this is acceptable within the norms governing legal frameworks, because they are not intended to guide public conduct. The lack of public notice of the law's content therefore does not run afoul of due process or other fairness considerations.Google Scholar
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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
Buncombe, Lakhani, , “Without Consent,” supra note 9.Google Scholar
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This is a vital part of the informed consent process. See Emanuel, E. J. Wendler, D. Grady, C., “What Makes Clinical Research Ethical?” JAMA 283, no20 (2000): 27012711, at 2706.Google Scholar
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See Dan-Cohen, , “Decision Rules and Conduct Rules,” supra note 4, at 648651 (discussing the implications of acoustic separation for the definition of criminal offenses in relation to common morality).Google Scholar
Admittedly, the United States falls far behind many other high income countries because it does not have a national compensation requirement for research related injuries. See, 45 C.F.R. 46.116(a)(6).Google Scholar
See also Kulkarni, A. Bhatt, A., “Causality Assessment: A Causality of Compensation?” Perspectives in Clinical Research 4, no4 (2013): 196198.Google Scholar
Drugs and Cosmetics (Third Amendment) Rules (2014) Gazette of India, Part II – Section 3 – Sub-section (i) G.S.R. 292 (E), available at <http://cdsco.nic.in/writereaddata/1Draft%20Rules%20on%20compensation.pdf> (last visited February 18, 2015).+(last+visited+February+18,+2015).>Google Scholar
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