Exceptions to Fully Informed Consent in Clinical Research

Abstract

The doctrine of informed consent is fundamental to all medical personnel involved in investigational research. Informed consent arose from the Helsinki declaration that stated, “concern for the interests of the subject must always prevail over the interests of science and society.” (6) As clinical research is a part of medical practice, it is reasonable to assume that exceptions to fully informed consent that are defendable in medical practice can be applied to clinical research as well. The exceptions to fully informed consent are waiver, incompetence, therapeutic priviledge, emergency, or proxy.