Full Informed Consent Questioned in Certain Circumstances

Under the right conditions, full informed consent is not ethically required for some types of health research, according to leading bioethics experts. Experts say in a commentary in the February 20 issue of the New England Journal of Medicine (NEJM) that “Current consent and oversight practices too often overprotect patients from research that has little impact on what matters to patients, while in other cases oversight practices underprotect patients from medical errors and inappropriate medical management.”

The position is a break from ethics principles that have guided research ethics and regulation for decades. The commentary addresses two concepts generating debate in the healthcare and bioethics fields: the idea of learning healthcare systems, as articulated by the Institute of Medicine (IOM), in which “continuous learning” from clinical practice feeds directly into improving future patient care; and randomized comparative effectiveness research (CER), in which patients are randomly assigned to different, widely used treatments for their condition – all of which are thought to be effective and safe – to determine which treatments work best for which patients.