Informed Consent: Pitfalls in a Patriarchal & Poorly Literate Society

Abstract

The judiciary enquiring suomotu into deaths following an oncology trial in central India opened a can of worms. Searching investigation suggested that informed consent was only a cosmetic exercise and the victim was usually illiterate, poor and for a monetary reward and without being informed of the consequences of the intervention, subjected to a drug trial. Further, the process of informed consent was dispensed with and “patient” was asked to sign at the bottom of the document, no questions asked. The ‘patient’ in these trials usually is from the urban poor or deeply patriarchal, poorly literate rural hinterland. This led to a media outcry, a witch-hunt, indictments, penal action and the regulatory body now insisting on a video filmed informed consent. The wheel has truly turned full circle. The regulators while seeking idealistic regulation seem to live in a utopian world. The patriarchal and illiterate populace of rural India is far removed from the rarefied world of videotaped informed consent and presents an ethically quixotic situation.

Disclosure of interest

The authors have not supplied their declaration of competing interest.