More than a signature, more than a permission....

 Ethics is, knowing the difference between what you have a right to do and what is right to do.

-Potter Stewart

When we doctors, pledge to the sacred Hippocratic oath, we little know how much of it will we follow in our daily clinical practice. Very few people know that the word “Doctor”, the ever so aspired prefix which we so proudly flaunt before our names, comes from the Latin term “docere” which means “to teach”, something that is also uttered when we take the oath. Consent is an integral part of that education that we should impart while approaching our patients. Informed consent to medical treatment is fundamental in both ethics and law.

The foundation of medical ethics rests on four cardinal pillars of autonomy, justice, beneficence, and non-maleficence. Informed consent embodies patient autonomy, as the right of competent adults to make informed decisions about their own medical care. Thus, it is required that we seek the consent/informed agreement of our patients prior to any procedure, diagnostic or therapeutic alike. Dentistry, in my humble opinion, is slightly different from conventional medical practice in the aspect that even the simplest of our procedures, including examination, involves a bit of invasiveness, making informed consent taking, almost inevitable and mandatory.

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Consent is often being considered as a legal agreement with documented evidence of two parties in unison about a particular matter. Law helps to understand many faces of consent-active, passive, implied, expressed, opt-out, written, verbal/oral, proxy, blanket, broad, and so on. While it’s in human behavior that consent is considered implied, it is the reason that most of the disputes occur, not only in clinical practice but various other fields like employment contracts, plagiarisms and copyrights, consumer services, and even marriage. As a safeguard from such disturbances, consent for clinical practice to be fool-proof should be active, expressed, written, and blanket with provisions of proxy and opt-out.

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To explain, a patient should be actively willing to sign an informed consent document, in his/her full senses with everything transparent between him/her and the doctor, who has honestly explained in person, about the disease, the nature of the treatment, the risks and benefits involved, the possible outcome, the adverse effects, the alternatives, and the patient’s cooperative participation. Maximum educating techniques should be followed to make sure the patient understands all the procedures (videos, brochures, diagrams, etc). All of this should be encompassed in the written document, which the patient should read or be read to. By signing the document the patient thus allows the doctor to go forward with the procedure, while also having the right to refuse and opt-out of the treatment at any stage with prior notice and proper documentation.

In case the patient is incapable of signing the consent (e.g, unconscious due to disease/under influence of any drug, or a child below the age of legal maturity) there should a provision for a proxy consent by the legal guardian, the next of kin or a responsible individual/ person of authority in order of decreasing priority.

For the sake of transparency, it is often advisable to have two copies of the consent document- one in the official language and the other in the regional language. All pages of the document should be attested with the signature/thumbprint of the patient and the signature of the doctor with a full signature and official stamp of the doctor on the final page. However, no matter how the documentation is being done, the essence of informed consent taking lies in the exchange of the dialogue between the patient and the doctor. Treatment should not proceed until the physician believes that the patient has made the right decision, keeping in mind that he/she has not directly influenced the patient’s decision.

Moreover, as per law age for legal maturity to give consent is at 12 years. Additionally, often for the sake of a greater good to the society, a doctor may arrange to exercise the “broad police” power a state has on the citizen to safeguard general public health and well being, and proceed for treatment against the consent of a medically proven psychologically ill individual, or a competent one with a contagious disease provided it is scientifically confirmed by psychiatric experts and public health workers respectively and provided the treatment is proven beneficial to the individual.

In a nation, where doctors are often considered Gods, we tend to behave like one and decide what is good for our patients, even against their will. However, irrespective of whether the refusal of an individual to treatment is rational or irrational, a doctor and/or the vicariously liable employing health enterprise, should respect that patient’s decision and withdraw any kind of responsibility from the patient preferring individual freedom.

It is quite interesting to find that analytical law for consent originates back to the primitive charge of the battery from where it evolved into an accusation of negligence. In medicine, when a practitioner carries out a treatment without the patient’s consent, performs a considerably different method than the one for which the patient agreed, surpasses the extent of the consent, or when a doctor who is different from the one to whom consent was given performs the procedure. All the above parameters satisfy the criteria of negligence on grounds that the doctor failed to perform his/her duty, medical care provided was substandard, and that there was somewhat a close association between the doctor’s conduct/failure with the injury of the patient.

Any injury due to medical negligence, as per the Indian Penal Code Sections 319 (hurt) and 320 (grievous hurt) is punishable for imprisonment up to 7 years. Consent otherwise involves IPC sections 52 (good faith), 80 (accident during a lawful act), 81 (act likely to cause harm, but done without criminal intent, and to prevent other harm), 83(act of a child above seven and under twelve of immature understanding), 88 (nothing which is not intended to cause death), 90 (consent known to be given under fear or misconception), 92 (act done in good faith without the consent), 304-A (causing death by negligence), 337 (hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others) and 338 ( causes grievous hurt to any person by doing any act so rashly or negligently as to endanger human life or the personal safety of others), breach of which involves imprisonment from 6 months extending up to 3 years.

Despite a busy clinical practice or the time of a medical emergency, consent should be given more importance than just obtaining a signature on a piece of paper. It is a progression towards patient-centered care and starts with the patients’ needs, expectations, fears, benefits, alternatives, and the option of opting for no treatment, thus helping the patient decide with the best suitable option. The decision the patient makes may not always be in agreement with us but, it should be the right one for that individual patient at that time. While signing the consent form, if a patient has been properly educated and made to feel secure, only then informed consent will have been truly given. A doctor’s approach should be flexible enough to adapt with different patients and lay the foundation for a good and lawful clinical practice.

After such a comprehensive discussion a very blatant thought that can be anticipated in the minds of practitioners is “where’s the time to do all this?” Agreed! Such communication is going to increase the time allotted to a patient, which may be counter-productive in a busy and booming practice. But let me share my insight there- “a good practitioner is a great talker. We can convince a patient for a root canal treatment over a dental extraction, a zirconia crown over a PFM (porcelain fused to metal) one, or an implant over a bridge; all this talk time acting as an investment for greater income returns. Similarly, a good talk with the patient confirming his/her consent is a good investment towards a good and legally safe clinical practice, confirming more patients to return and newer patients to come looking for a safe doctor.