title: New rules for clinical trial-related injury and compensation.
abstract: 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.
authors.affiliation: Post Graduate Student, Symbiosis School of Biomedical Sciences, Symbiosis International University, Lavale, Mulshi, Pune 412 115 INDIA.
authors.forename: Khushboo
authors.initials: K
authors.lastname: Choudhury
authors.forename: Ravindra
authors.initials: R
authors.lastname: Ghooi
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000009:adverse effects* / Q000941:ethics / Q000331:legislation & jurisprudence; D035881:Compensation and Redress / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D007194:India; D035842:Research Subjects / Q000191:economics* / Q000331:legislation & jurisprudence; D014947:Wounds and Injuries / Q000191:economics* / Q000209:etiology