Compensation conundrum.

Perspectives in Clinical Research
Shoibal Mukherjee

Abstract

Pressured by questions tabled in parliament that point to a lack of adequate enforcement of regulations, the DCG(I) has abruptly initiated action to ensure payment of compensation for trial-related injuries. While it is astounding that non-compliance to the existing regulations could have gone unnoticed by quality assurance staff as well as by the ethics committees and the regulator, for over six years, sudden enforcement of the regulation has thrown up issues and challenges that are difficult to resolve in the absence of an adequately debated and thought-through guidance. In implementing regulations for suo moto compensation, India is seeking to establish a practice not previously tested elsewhere in the world. There is no doubt that industry must support the idea of putting patients first, but procedural considerations in fixing causality and determining the quantum of compensation promise to raise questions of morality, ethics, and jurisprudence that will not be easy to answer.

References

Jan 1, 1989·Journal of Clinical Epidemiology·T A Hutchinson, D A Lane
Mar 10, 1999·JAMA : the Journal of the American Medical Association·T Brewer, G A Colditz
May 5, 2006·The New England Journal of Medicine·Robert Steinbrook
Feb 26, 2011·Journal of Hepatology·Miren García-CortésRaúl J Andrade

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Citations

Apr 8, 2015·The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics·Megan E Larkin
Apr 4, 2019·Asian Bioethics Review·Shivkrit Rai, Vishwas H Devaiah

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