Informed consent in vaccination in India: Medicolegal aspects

Abstract

The doctrine of informed consent forms an integral part of any doctor-patient relationship. It serves two-fold as it develops trust and confidence in the patient for the doctor after being told about the plan of action; conversely the doctor can carry out planned medical interventions in a more composed manner, being confident in the protection of this doctrine if anything untoward occurs. Informed consent gives a blanket shield against compensation and criminal negligence charges filed by patients if the doctor has not deviated from standard practices of treatment or intervention or if no evidence of mal intention is forthcoming. Informed consent is applicable in most of the treatment modalities in which any intervention/invasive procedure is to be done or if any risk of complication is well known or documented. Surprisingly, even when serious life threatening complications are not only reported but on a steady rise due to vaccines, informed consent in vaccination is neither in vogue nor practice. Even in the US, there is no federal requirement for informed consent before vaccination,¹ even though National Childhood Vaccine Injury Act and the Vaccine Compensation Amendments are in place.² This paper attempts to present an overall comment on the necessity of informed consent before any vaccination especially in the Indian context in the backdrop of the beginning of vaccine compensation claims and litigation against the complications of vaccination in India.