The Secret to Avoid Fines and Cases for Lack of Informed Consent
The recent incidents of violence against doctors underscore how a strong understanding of informed consent is essential, now that patient-doctor conflicts are becoming more common.
The Secret to Avoid Fines and Cases for Lack of Informed Consent
In case, you have been living under a rock a Mumbai hospital has been fined a lakh for lack of informed consent and proper documentation. Moreover, if you have ever wondered the guidelines are misleading, then you probably already believe that other countries do it better and obsess over lessons from around the world.
Here are the key things that you need to know about informed consent.
What is informed consent?
Patients are asked to agree in writing to the doctor’s plan of care if there are significant possible risks and is part of informed consent. It recognizes his/her need to know about a procedure, surgery, or treatment before he decides whether to have it.
What is the Consent Form About?
If a patient has gone through these steps and decide to get the treatment or procedure, he is asked to sign a paper called a consent form. The completed and signed consent form is a legal document that lets the doctor go ahead with the treatment plan. The consent form names the procedure or treatment.
“When a patient is a competent adult, there is no question of someone else giving consent on her behalf. Consent given only for a diagnostic procedure, cannot be considered as consent for treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the additional unauthorized surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in action in tort for negligence or assault and battery. The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until the patient regains consciousness and takes a decision,” says Dr Suganthi Iyer, Deputy Director, Hinduja Hospital.
If the patient decides that he doesn’t want the procedure or treatment, he may be asked to sign an informed refusal form or a form that states you are choosing not to follow medical advice. Your signature on this form implies that you know the risks of refusing, so be sure that you understand these risks and know your other options before you sign.
Guidelines set by the Medical Council of India
If a medical practitioner attempts to treat a person without valid consent, then he will be liable under both tort and criminal law.
The Medical Council of India (MCI) has laid down guidelines according to which consent is required in writing before operating.
For routine types of treatment, implied consent would suffice
For detailed types of therapy, ideally, express oral consent may be needed
For complex types of treatment, written express permission is required
Capacity and Information while seeking medical consent
To be competent to give legally valid consent, the patient must be endowed with the ability to weigh the risks and benefits of the treatment that is being proposed to him. The law presumes that such a skill is generally acquired with the attainment of the age of maturity. A person who has attained a competent age and who has a sound mind can give valid consent to the medical practitioner for any treatment. Persons who have reached the age of 18 are generally considered to have attained the age of maturity and are competent to give consent.
If the patient is incompetent to give consent, then the permission may be obtained from the attendant of the patient.
Right of Autonomy of the Patient
A medical practitioner in India must provide all the necessary information to the patient in a language that is understandable to him. “The question is whether in action for negligence/ battery for the performance of an unauthorized surgical procedure, the doctor can put forth as a defence the consent given for a particular operative procedure, as consent for any additional or further operative procedures performed in the interests of the patient. It was held that additional procedure could not be justified under the principle of necessity if there is no immediate threat or danger to the patient’s health or life and it would not have been unreasonable to postpone the operation to secure the patient’s consent. The fact that the doctor found it convenient to perform the additional operation without consent as the patient was already under general anaesthetic was held to be not a valid defence. It was held that the additional or further treatment which can be given (outside the procedure) should be confined to only such treatment as is necessary to meet the emergency, and as such needs to be carried out at once and before the patient is likely to be in a position to make a decision for himself,” says Dr Iyer.
Does the law protect doctors?
A doctor acting reasonably under normal circumstances is always protected, and he is never expected to play the role of an investigative agency.
Emergency and Consent
The Supreme court has emphasized further that every doctor, whether at a Government hospital or otherwise has the professional obligation to extend his services with due expertise for protecting life. No law or state action can intervene to avoid or delay the discharge of the paramount duty cast upon members of the medical profession. The responsibility of a doctor is total and absolute.
Dr Lalit Kapoor, a medico-legal expert points out that informed consent is a potential minefield as far as medico-legal liability is concerned, is patient consent for undertaking treatment.
“By now, all of us are aware of the importance of taking consent. Administering treatment in the absence of consent can be construed as negligence per se and even worse, could attract the criminal charge of assault and battery. Lack of consent can amount to a moral, civil and criminal wrong. It is, therefore, vital to ensure valid, informed consent before accepting the responsibility to treat a patient. Lately, consumer courts have magnified the issue of informed consent, and if there is no evidence of negligence; otherwise, lack of informed consent is cited as the offence. Hence, the great importance of understanding the concept of legally valid consent.
Ingredients of informed consent -Make sure the patient understands the nature of his condition, the alternative treatments or procedures, nature of the proposed treatment, risks of proposed or alternative methods and the chances of success or failure of the treatment.
Mere signature on a pre-printed consent form is not adequate. It should be recorded explicitly that a discussion took place, and patient/relatives have explained the contents.
Consent should be ‘procedure specific’. Courts fault blanket consents.
The written permission should preferably be in a language which the patient/relatives can understand.
Refusal of consent or denied consent should be recorded, signed and witnessed.
Quite recently in a Delhi hospital, the procedure of inserting a central venous line resulted in injury to the jugular vein following which patient was shifted to a higher centre for emergency treatment. A complaint before the National Consumer Forum ended up with compensation of Rs 7 lakhs being awarded to the patient. The court averred that a specific, informed consent ought to have been taken for the procedure which was invasive in nature and had the potential of causing severe complications,” he concludes.