Consent is an agreement as to action or opinion or compliance in or approval of what is done or proposed by another. This consent becomes all the more important in the medical profession where it determines the liability of the doctors or hospitals in case of medical negligence. A valid consent should have three elements-it must be voluntarily given, the person must be competent and it should be given specifically for that treatment. It has to be valid to proceed with the treatments and sometimes the patient has the power to refuse to consent to a particular treatment. As it has great significance in medical treatments today there is a general trend of circulating an ‘informed consent cum undertaking’ form to get the consent of the patient before the treatment. This written consent or form makes the doctors or hospitals inculpable before the law. However, the peculiar point about these forms is that in many cases they are not informative enough to get valid consent from the patient. This premise questions the validity of these forms itself and renders them as futile.
Recently, the NCDRC in Vinod Khanna v. R G Stone Urology and Leproscopy Hospital and others, while dealing with a case of alleged medical negligence observed that a pre-printed and fixed informed consent cum undertaking forms with limited blank spaces for handwritten entries are deceptive and a sign of administrative arbitrariness on the part of the hospital. It further held that this kind of form is unfair trade practice under Section 2(1) (r) of the Consumer Protection Act, 1986. The NCDRC found the hospital not negligent in the case but it was liable to pay Rs. 10 lakhs and terminate the practice of generating such pre-printed forms to acquire the consent of patients for treatment. These remarks have opened the doors for making the process of obtaining consent from patients a productive and informative exercise which results in a valid consent and not a mere consent on paper.
This article seeks to analyze various tests regarding valid consent, jurisprudence behind consent in medical treatment, and its effect on the doctor-patient relationship. It further explores the legal understanding of consent in India with the help of laws and decisions of courts. It also throws light on the efficacy of pre-printed forms and modifications which can make them a valid source of consent.
JURISPRUDENCE BEHIND THE CONSENT OF A PATIENT
The discussion related to the voluntary consent of a human being was for the first time codified in the Nuremberg Code of 1947. The code did not mention informed consent per se but it was a step in changing the doctor-patient relationship which grants slight autonomy to patients. The Helsinki Declaration of 1964 went further to make informed consent the acceptable norm in the medical profession. UNESCO Universal Declaration on Bioethics and Human Rights (2005) emphasized the need to take informed consent of a patient before subjecting him/her to any treatment. It also empowered him to revoke his consent at any point of time.
All these declarations greatly contributed to changing the attitudes of medical fraternity towards their patients. It marked a shift from medical paternalism to patient autonomy. This autonomy includes autonomy over one’s body. It strengthens self-determination which is an integral part of being a human that is the right to make a choice for oneself. It also includes the right to refuse for a particular treatment and right to know about the treatment. So if any concealed fact or deceptive information influences the judgment of a patient then it will be undermining the dignity of the patient. However, during these times various standards have been laid out by courts to evaluate informed consent which makes it difficult to have a uniform parameter to assess the consent of a patient.
EXISTING LEGAL POSITION ON CONSENT OF A PATIENT
The definition of valid consent required from a person is scattered in various legislations. Consent is a part of the law of torts. Similarly, it is also given a place in IPC such that Sections 87-96 covers all the aspects related to consent that can make an offence excusable. Section 53 of CrPC also states the instance where a doctor does not need to take the consent of the arrested person to examine him in the presence of a sub-inspector. Section 13 of the Indian Contract Act 1872 postulates consent in the form of consensus ad idem. Consent is also recognized in Section 4(a) of the Medical Termination of Pregnancy Act, 1971 wherein a girl under 18 years of age cannot give valid consent to terminate her pregnancy. It is apparent that there is no single, clear, and uniform definition governing consent taken from a patient. This opens up a lot of possibility of manipulating the obtained consent to take undue advantage of a patient. Though Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 mentions taking consent of the patient in writing before performing an operation, it does not lay down a parameter to evaluate the consent so obtained. Therefore, a patient is left vulnerable before the law.
The courts have laid down various standards to examine the validity of consent obtained from a patient. It is divided into two broad categories mainly-The professional standard test or Bolam test adopted by the Courts in the UK which states that if a doctor discloses information about treatment and risks involved with it as would be made by a reasonable practitioner similarly situated then he is not negligent. This reasoning was also followed in the Sidaway case. Bolam test has been generally accepted in India by Courts in cases of Achutrao Haribhau Khodwa v. State of Maharashtra, Vinitha Ashok v. Lakshmi Hospital and Indian Medical Association v. VP Shantha.
The Reasonable prudent patient test or Canterbury’s test followed in American Courts which asks the doctors must disclose to the patient all the information that would be material to the patient in making a decision on proposed therapy. It demands proper communication with the patient disclosing absolute information about the treatment. This test has not been followed in India due to a lack of awareness among patients and poor literacy rates.
Bolam test has been rejected by the UK Supreme Court itself in the Montgomery case. However, India is still following the Bolam test. In Samira Kohli v. Dr. Prabha Manchanda, the Supreme Court failed to adopt Canterbury’s test stating that we have, however, consciously preferred the ‘real consent’ concept evolved in Bolam and Sidaway in preference to the ‘reasonably prudent person test’ in Canterbury, having regard to the ground realities in medical and healthcare in India. However, it hinted at adopting a reasonably prudent patient test in the future if the conditions improved which is a bleak possibility as of now.
TROUBLE WITH PRE-PRINTED INFORMED CONSENT CUM UNDERTAKING FORMS
Respecting the autonomy of a patient is the moral duty of any health institution as it is grounded in preserving his dignity as an individual provided in Article 21of the Constitution. Pre-printed forms take away this right from the patient which is a violation of his fundamental rights. It also indirectly favors medical paternalism. These pre-printed forms are an offspring of the Bolam test which is outdated. Informed consent cum undertaking forms with limited blank space for handwriting throws light on the one-handiness of the hospitals which downplays the role of patients in their own treatments. Another problem is the patient’s inability to understand the language of these forms, which is mostly English, which hinders the participation of a patient in the whole procedure. There is also not enough time given to patients to understand the medical terms printed on the forms as it is handed to him in the last minutes before treatment. Thus these forms only serve as a shield for those doctors and hospital management who have not discharged their duty properly. Most of the patients don’t even know the meaning of the terms on the consent form and still sign it. Therefore, it does not culminate into valid consent and only leaves patients vulnerable before the law.
A patient has an ethical as well as a legal right to make an informed decision regarding his treatment. If anything deprives him of this choice then the consent given is not valid. It is important to ascertain how informed a patient is before giving his consent for the treatment. Now is the time to move from the Bolam test to the Canterbury test which is more patient-centric. It is the need of the hour to make medical fraternity more sensitive about the problems faced by confused patients who trust their lives in a doctor’s hand.
These pre-printed forms or fixed ‘informed consent cum undertaking’ forms are tools to circumvent the obligation to inform the patient fully about the treatment. It is imperative to make these forms patient-specific which implies, it should be understandable, have sufficient space for handwriting, and preferably in the local language. These forms should also be signed by the patients in the presence of a witness that can include their family members, friends or any acquaintance to ensure transparency in the whole process. A list of various procedures, or tests involved in the treatment should be attached to the consent form. Only then can a valid consent be obtained which will reflect the true intention of a patient.
Views are personal.
Image credits: Association of American Medical Colleges (AAMC)
ABOUT THE AUTHOR
Janhavi Somvanshi is currently pursuing B.A. LL.B. (Hons) from National Law University, Jodhpur.
Bolam v. Friern Hospital Management Committee,  1 WLR 582.
Sidaway v. Board Governors of the Bethlem Royal Hospital,  AC 871.
Canterbury v. Spence, 1972  Federal Reporter 2d. 772.