Informed Consent: The Heart of Medical Law

Informed Consent: The Heart of Medical Law “With Henrietta unconscious on the operating table…though no one asked if she wanted to be a donor—[Dr.] Wharton picked up a sharp knife and shaved two dime-sized pieces of tissue from Henrietta’s cervix.” – The Immortal Life of Henrietta Lacks, pg. 33 The doctrine of informed consent, aimed at the lawfulness of health assistance, tends to reflect the concept of autonomy and decisionally-capacitated consent. It means that before a person’s body is put under knife for surgery, he/she knows what the doctor is going to do and in knowledge of that has given consent for the same. An informed consent can be said to have been given based upon a clear appreciation and understanding of facts, implications, and consequences of an action. It is a tool used to govern the relationship between physicians and patients.   Introduction It is well known that the patient must give valid consent to medical treatment; and it is his prerogative to refuse treatment even if it will save his/her life. This has risen a number of ethical debates and lies at the core of medical law today. The twentieth century witnessed development of a great many medicines and vaccines that were able to eradicate diseases such as small pox and polio. These advances required years of research and testing. However, some of these miracle drugs have a horrible dark history. Many of the early advances were made at the expense of many asylum inmates and prisoners. The test subjects were not informed, leave alone of the question of asking. Moreover, many such horror stories were witnessed in the World War II where medical and experimental atrocities were committed by the German Nazi regime. In response to the horrors witnessed, the Nuremberg Code of 1947 was developed in which the expression of doctrine of informed consent is first found. he code makes it mandatory to obtain voluntary and informed consent of human subjects. Similarly, the Declaration of Helsinki, 1964 emphasises the importance of obtaining free informed consent. It is in this declaration that “free” finds its first mention.   Legal Basis of Consent In accordance to Article 21 of the Indian Constitution, every patient has a legal right to autonomy and self-determination in context of medical treatment. If a medical practitioner attempts to treat a person without valid consent, he would be liable under both tort and criminal law. Since early beginnings, the courts have used two legal theories to deal with the obligations of doctors towards their patients, the theory of battery (criminal law; unconsented touching) and the theory of negligence (tort law; a failure to use reasonable or due care that results in unintentional harm). The theory of battery holds that “the defendant is liable for any unintentional act that results in physical contact for which plaintiff has not given express or implied permission." In the case of Schloendorff v. Society of New York Hospitals, a famous statement was issued which seems to back the right to self-determination: "Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without patient’s consent, commits an assault for which he is liable in damages." The theory of negligence holds that “the defendant is liable for a careless action or omission when the defendant had an obligation toward the plaintiff and careless action or omission causes an injury.” In case of physicians' negligence in informed consent, an action would have to show that a physician violated a duty of "due care to inform a patient, that this breach resulted in a financially measurable injury, and that a reasonable person would not have consented. In informed consent liability, negligence (under tort law) is a preferred theory because battery lacks a credible perspective from which to evaluate physician conduct.   Intentional Non-Disclosure Interestingly, in India, the entire gamut of laws on consent turns into complex propositions if an emergency medical situation arises. In some landmark cases, the Supreme Court of India has ruled that a medical practitioner has a duty to treat a patient in emergency. Putting emphasis on the paramount duty of any “welfare state”, the Supreme Court stated that Article 21 imposes an obligation on the State to safeguard the right to life of every citizen of the country. In such situations, preservation of human life gains paramount importance. It has been held that “Failure on the part of a government hospital to provide timely medical treatment to a person in need of such treatment results in the violation of his right to life guaranteed under Art. 21” in the case Samera Kohli v Dr. Prabha Manchanda and Another. Proceeding in the same line, the court emphasized that every doctor has the professional obligation to extend his services with due expertise for protecting life of the patient. No law can interven to delay or avoid discharge of the paramount obligation cast upon members of the medical profession. So, in case of emergency situations, doctor has to start on the best possible path to save the patient; even if he does not have consent of the patient.   The Problems and Limits of Informed Consent in Practice  Although the doctrine of informed consent promotes ideals worth pursuing, successful implementation of these ideals is yet to occur. What happens in practice is that layers, doctors and hospital administrators more often than not use consent forms to protect medical practitioners and medical facilities from financial liability. Consequently, ethicists, legal theorists, and physicians need to do much more to explain how human rights and human dignity relate to the practice of medicine and how the professionals can and need to promote them. This is especially important because patients' vulnerability has increased tenfold just as the complexity and power of medical science and technology have increased.