ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

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Clinical Trial-Related Injury

Note on Formula to Determine Compensation

This article provides a detailed critique of the formulae to provide compensation to subjects of clinical trials who may suffer serious adverse effects during their participation. The present formulae used by the Central Drugs Standard Control Organization display a lack of medical ethics and disregard the accepted norms.

Compensation in the context of clinical trial-related adverse events, ranging from relatively minor harm to major injuries (temporary disabilities) or even disastrous injuries (leading to permanent disability or even death) are some of the issues raised consistently by concerned civil society. Ambiguities with regard to who should be compensated and the quantum of compensation continue unabated.

The Central Drugs Standard Control Organization (CDSCO) prepared a formula for compensation in the case of death during clinical trials according to the recommendation of the A K Agarwal Committee. In January 2013, amendments were made to the Schedule Y of the Drugs and Cosmetics Rules to include Rule 122DAB providing compensation for death during clinical trials. However, no standard guidelines were formulated at the time to determine the quantum of compensation in case of serious adverse events other than death.

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