Informed consent to clinical research in India: A private law remedy. (September 2020)

• Record Type: Journal Article
• Authors: Bhakuni, Himani
• Is Part Of: Medical law international. Volume 20:Number 3(2020)
• Page Start: 256
• Page End: 283
• Publication Date: 2020-09
• Subjects: India -- informed consent -- legal doctrine -- common law -- protection of research participants -- health research -- clinical trials; Medical laws and legislation -- Periodicals; Legislation, Medical -- Periodicals; 344.041
• DOI: 10.1177/0968533220958185
• Languages: English
• ISSNs: 0968-5332

Abstract

There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this 'nascent doctrine' to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India's patients and research participants.