Informed Consent An Emerging Legal Challenge

While consent per se has been a long-standing practice in some areas of medicine, it is only in the last century that informed consent has been accepted as an integral part of medical practice

Informed Consent is an emerging Legal, Regulatory and Ethical prerequisite for any medical and/or research. The practice of informed consent plays a critical role in medicine as we are entering the era of patient as consumer and doctor as service provider. In recent years, there has been an increase in the number of malpractice and medical negligence suits due to lack of informed consent or inadequate consent from the patients for various procedures. The concept of consent is not new to healthcare or research.

Consent is a long-standing practice in some areas of medicine, yet only in the last century has informed consent been accepted as an integral part of medical practice. Informed consent is nothing but authorisation of an activity based on an understanding of what the activity would entail.

In India, Informed Consent was practically non-existent till the Consumer Protection Act, 1986, was implemented. The fundamental principles of autonomy were first expressed in the Nuremberg Code of 1947 which was adopted immediately after World War II in response to medical and experimental atrocities committed by the German Nazi regime. The code makes it mandatory to obtain voluntary and informed consent of human subjects. The model for consent established in the Nuremberg Code has continued to evolve through the many revisions by the World Medical Association in Declaration of Helsinki. The Declaration highlighted the importance of informed consent for medical research. All medical procedures, including examinations, diagnostic procedures and medical research on patients in the absence of consent constitute assault (IPC 351).

What is CONSENT?

Consent means an agreement, compliance or permission given voluntarily without any compulsion.

Section 13 of The Indian Contract Act states that 'two or more persons are said to consent when they agree upon the same thing in the same sense'.

Common meaning of consent is permission whereas the law perceives it as a contract i.e. an agreement enforceable by law.

What is Informed Consent?

Informed Consent means an agreement, compliance or permission given voluntarily without any compulsion. It can be defined as "the voluntary and revocable agreement of a competent individual to participate in a therapeutic or research procedure, based on an adequate understanding of its nature, purpose and implications."

As per the Mental Healthcare Bill, 2013, "informed consent means consent given for a specific intervention, without any force, undue influence, fraud, threat, mistake or misrepresentation, and obtained after disclosing to a person adequate information including risks and benefits of, and alternatives to, the specific intervention in a language and manner understood by the person.

The Doctor has a duty to reveal every detail that any Doctor employing reasonable care would reveal to a patient with respect to foreseeable risks of harm resulting from a proposed course of treatment. This disclosure must be provided so that a patient can wisely exercise judgement by balancing the probable risks against benefits. The disclosure also provides the patient an opportunity of weighing options of undergoing the proposed treatment, alternative treatment, or none at all.

Informed Consent to medical treatment is a complex topic. In a medical context, this is attributed to the right of a patient to decide the course of treatment the patient would want to opt for. The concept of Informed Consent has evolved with time and it plays a critical role in medicine as the patient is treated as consumer and doctor as service provider. In recent years, there has been an increase in the number of malpractice and medical negligence suits due to lack of informed consent or inadequate consent from the patients for various procedures. The rights of patients have also undergone a sea change with patients having wider exposure to understanding their rights. Informed Consent is not just a plain paper. It is an agreement that binds a patient and a doctor to their rights and obligations.

The law of consent is not fully developed in India, although Indian courts have often referred to the principles of patient autonomy and human rights. In such situations, obviously, one has to refer to the principles of the Indian Contract Act, 1872 and the Indian Penal Code, 1860. The ethical principle of patient autonomy and human rights gives patients the right to decide and choose the course of treatment a patient would want to undergo. The rights are enshrined in Article 21 of Fundamental rights, under the Indian Constitution. The right to life empowers patients to obtain quality treatment and cure. The relationship between a medical professional and his patient is a contract by parties competent to contract giving rise to contractual obligations.

It is not necessary to disclose every detail, but all such details which a "reasonable person" would need to arrive at a decision, must be provided. Therefore, it is mandatory to disclose all risks of serious complications, even if they occur very rarely. Less serious risks also need to be discussed if they occur more frequently. This may occur in one event/encounter or chain of events/encounters. This is not restricted to a single event and can be attributed to a chain of events.

The concept of Informed Consent, in India, saw a sea change after some landmark judgements were pronounced by the Hon'ble Supreme Court of India. One such landmark judgement was Samira Kohli vs. Dr. Prabha Manchanda.

The Hon'ble Supreme Court of India in Samira Kohli vs. Dr. Prabha Manchanda, observed that the patient Samira, an unmarried woman aged 44 years, consulted Dr. Manchanda on May 9, 1995, complaining of prolonged menstrual bleeding. An ultrasound test was conducted and the doctor advised her to return the next day for a laparoscopy test. Samira and her mother returned to the clinic the following day. Samira was admitted and her signature taken on the admission and discharge card, consent form for hospital admission and medical treatment and consent form for surgery.

The admission card showed that admission was for "diagnostic and operative laparoscopy." The patient was put under general anaesthesia and subjected to a laparoscopic examination. While Samira was still unconscious, Dr. Lata Rangan came out of the operation theatre and took the consent of the patient's mother for a hysterectomy. Thereafter, Dr. Manchanda removed the patient's uterus and, in addition, removed the ovaries and fallopian tubes. The patient then left the hospital without settling the bill. Dr. Manchanda lodged a complaint with the police that the patient's friend, Commander Zutshi, threatened the doctor and got Samira discharged against medical advice and without clearing the bill. The patient too lodged a complaint against the doctor alleging negligence and unauthorised removal of her reproductive organs.

The Hon'ble Supreme Court held that, 'Consent' in the context of a doctor-patient relationship meant granting of permission by the patient for an act to be carried out by the doctor. Consent, in some circumstances, could be implied from the patient's actions. The consent is implied when for eg.a patient enters a dentist's clinic and sits in the dental chair, consent for examination, diagnosis and consultation is implied. The 'adequate information' to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgement as to whether he should submit himself to the particular treatment. The court also declared that except where consent can be clearly and obviously implied, there should be express consent.

Conclusion: Considering the legal implications and penalties that would entail, it is important to realise and practice the concept of Informed Consent. Doctors and patients must be more vigilant. The level of disclosure has to be case-specific. Although, one can only take adequate safeguards and act with conscientiousness, being transparent and maintaining a good rapport with patients always works in the long-run.

Disclaimer - The views expressed in this article are the personal views of the author and are purely informative in nature.