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Authored by Ammu Brigit

Informed consent being one of the fundamental principles of good clinical practice is a legal requirement prior to conduct of surgeries or other medical procedures by doctors/hospitals. Failure by a  doctor to obtain consent from the patient or the guardian before the conduct of an operation is a violation and is considered to be misconduct under Chapter 7 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2012.In Samira Kohli vs. Dr. Prabha Manchanda & Ors (2008 2 SCC 1) (“Samira Kohli Judgement”), the Hon’ble Supreme Court of India emphasised that importance of obtaining informed consent from the patients and how the responsibility is upon the doctor to disclose necessary information to the patient to obtain his consent. The law does not provide a standard form for obtaining consent. The known and widely accepted way of obtaining the consent from the patients or the guardian is getting signature on the pre-printed consent forms. Recently in Vinod Khanna vs. R.G Stone Urology and Laparoscopy Hospital & Ors (Order), National Consumer Disputes Redressal Commission (NCDRC) pronounced that obtaining consent in a pre-printed consent forms is an unfair trade practice.

Background and Decision

Vinod Khanna, a patient with abdominal and urologic difficulties approached Fortis Hospital, New Delhi and owing to financial difficulties then approached RG Urology and Laparoscopy Hospital (RG) for treatment. The patient could not get complete treatment for his disease and further suffered injury and complications. Pursuant to which, he filed a complaint in State Consumer Disputes Redressal Commission and the then in NCRDC.

NCRDC took reference to standard books on Surgery, Urogenital Pathology, constituted a board constituted of three independent doctors and also perused the informed consent forms taken from the patient at RG prior to the surgery and other medical records. Pursuant to which, NCRDC held that there was no deficiency of service or medical negligence on part of the both the hospitals.

Regarding Informed Consent in the Order

NCDRC particularly noticed the nature of informed consent obtained from the patient in this case and noted it to be an act of administrative arbitrariness. Quoted below is the NCRDC’s opinion on the pre-printed consent forms:

“We but note that a pre- printed and fixed ‘informed consent cum undertaking’ form, with blank spaces for limited select handwritten entries and for the signatures has been used by the hospital. The main body of the form is pre-printed and fixed. It can fit into any procedure, any doctor, and any patient, after filling up the blank spaces for the limited select handwritten entries and getting / affixing the signatures. We note this to be administrative arbitrariness and one-sided high handedness, and to be unfair and deceptive, on the part of the opposite party no. 1 (hospital), for which, though, the complainant has not been prejudiced in this particular case”.

NCDRC held that the pre-printed consent form is an unfair trade practice section 2(1) (r) under Consumer Protection Act 1986. It also instructed the hospital to deposit with Consumer Legal Aid Account of NCDRC a sum of Rs. 10 lakhs as cost for such unfair trade practice, and directed it to discontinue the use of pre-printed consent forms with immediate effect.

Impact of the Order

The NCDRC Order calling out the pre-printed informed consent form, will require doctors and hospitals to have a relook at the way their informed consent have to be structured going forward. One needs to see that the reason why NCDRC struck down the pre-printed informed consent form was that it is a form that could fit into any procedure, any doctor, and any patient. A good consent that is obtained from the patient should have information about the medical condition of the patient, the planned diagnosis, name and details of the patient, guardian and the doctor.

In Samira Kohli Judgement, the Hon’ble Supreme Court of India laid down the following with regard to the informed consent:

a. A “real and valid consent” [(i.e.)capacity and competence to consent] should be obtained from the patient prior to the commencement of the treatment, who accords consent voluntarily after being furnished with adequate information such as nature and procedure of the treatment, its purpose, benefit and effects, alternatives available, substantial risks and the adverse consequences of refusing the treatment to the patient.

b. A consent obtained for a diagnostic procedure will not act as consent for therapeutic treatment, and a consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. Any additional surgery without consent can be performed only to save the life of the patient or preserve the health of the patient.

c. A common consent can be obtained diagnosis and operative procedures which are contemplated and also for a particular surgical procedure that may become necessary during the course of the surgery.

d. The nature of the information furnished should depend upon the physical and mental condition of the patient, nature of treatment and risks and consequences attached and should be of the extent which is accepted as normal and proper by skilled and experienced men in the particular field of medicine, and the American standard for consent is not used by Indian courts as of now.

Reading together the above guidelines on informed consent by Hon’ble Supreme Court with the NCDRC’s Order which held the use of pre-printed consent forms that fits in any procedure, any doctor and any patient as an unfair trade practice, hospitals and doctors need to revisit their consent forms, re-format them so that the consents are procedure specific, and record therein the elements outlined by the Supreme Court in Samira Kohli Judgement.

Where in a particular case the procedure specific consent form would not apply, then a patient specific forms may get necessitated. Hospitals may have to commence using electronically generated specific consent forms for each patient rather than using pre-printed consent forms, so as to avoid issues like the one in the matter of R.G Stone Urology and Laparoscopy Hospital.

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