Negligence without a patient: medical negligence in clinical trials in India and the comparative study of South Korea and Australia

Abstract

Clinical research has migrated toward low- and middle-income countries, and India became a leading host before consent failures and participant deaths triggered a regulatory reckoning in 2013. The injured trial participant occupies an awkward position in medical negligence law: the intervention is experimental, its risks are by design incompletely known, and no settled standard of care governs the researcher's conduct. This study compares three jurisdictions. India, a common-law system, has adopted statutory no-fault compensation; South Korea, a civil-law system, relies on regulatory approval and indemnity insurance; Australia, a common-law system, is shaped by a landmark judicial standard and subsequent civil-liability reform. India's obligation requires sponsors to compensate trial-related injury without proof of fault, reaching injuries only associatively connected with a trial, making its principle the most protective in form. South Korea channels protection through institutional review boards and indemnity insurance, leaving the standard of care to malpractice litigation. Australia combines notification-based approval with a court-determined standard derived from Rogers v Whitaker, tempered by the customary-practice defence and supplemented by health complaints commissions. No jurisdiction performs well on compensation certainty, standard-of-care clarity and access to justice at once. The comparison supports three reforms for India: a defined standard of care, an independent compensation authority, and a clarified relationship between the no-fault remedy and the civil claim.