Informed Consent

Abstract

History of tradition of following ethical code in medical practice is very ancient and it could be traced as back as 3500 year old document of Ebers Papyrus (Berdon 2000). Later Greek and Egyptian teachings also emphasized upon ethical practices in medicine. But the concept of formally taking consent (and informed consent) with emphasis on patients’ rights and his/her autonomy emerged in early 20th century when some law suits were filed in courts, particularly in USA. Later the well known infamous atrocities carried out by Nazi doctors on prisoners during Second World War and consequent verdict by Nuremberg tribunal and milestone declaration of Nuremberg made a land mark in the history of medical ethics and provided a ground on which the doctrine of ‘Informed Consent’ is built. This paper discusses and analyzes various ethical issues related to informed consent. How the obligation of taking informed consent was established in the clinical practice and biomedical research. Discusses whether informed consent is a moral obligation or legal necessity with reference to various historical cases and presentation of views by some authors. This paper also analyzes famous legal litigations that helped to provide foundations for the patients’ rights and autonomy in clinical, such as cases of Shoendorff v. New York Hospital of 1914; Prince v. Massachusetts litigation of 1944; Canterbury v. Spence lawsuit of 1972; Large v. Superior court of Arizona legal case of 1986 and Younts v. Francis Hospital suit of 1986. A discussion is also made regarding five universally accepted components of informed concept (disclosure to the patient/research subject, comprehension by the patient, his/her competency, voluntariness and willingness), which are variously and sometimes conflictingly interpreted in different contexts and situations. Situations are highlighted where these problems create ethical dilemmas and legal conflicts in clinical and research environment and a reference is made to ongoing discussion whether informed consent has been primarily devised for protection of the patients or it is a tool to rescue physicians when they are brought to courts to face law suits. Keywords: Informed consent, Autonomy, Ethical principles