New rules for clinical trial-related injury and compensation

• Published in: Indian journal of medical ethics Vol. 10; no. 3; p. 197
• Main Authors: Choudhury, Khushboo, Ghooi, Ravindra
• Format: Journal Article
• Language: English
• Published: India 01.07.2013
• Subjects: Adverse Drug Reaction Reporting Systems - legislation & jurisprudence; Clinical Trials as Topic - adverse effects; Clinical Trials as Topic - ethics; Clinical Trials as Topic - legislation & jurisprudence; Compensation and Redress - ethics; Compensation and Redress - legislation & jurisprudence; Humans; India; Research Subjects - economics; Research Subjects - legislation & jurisprudence; Wounds and Injuries - economics; Wounds and Injuries - etiology; India
• ISSN: 0974-8466; 0975-5691
• DOI: 10.20529/IJME.2013.058

The rules for compensation for injury and death in clinical trials have recently been notified. These rules clarify that medical management of all injuries in clinical trials is mandatory and in cases in which injury or death is related to the clinical trial, the subject (or nominee) is entitled to compensation over and above the medical management. They also specify procedures and timelines for reporting serious adverse events. These require simplification. The rules will hopefully make clinical trial safer for subjects and investigators alike. However, they suffer from certain inconsistencies that should be reconsidered. They need to be modified so that they do not damage the industry.