Informed consent. How important are they?

Informed consent denotes the legal and ethical right of an individual to exercise autonomy and self-determination. Treating a patient without properly documented informed consent would make the physician potentially vulnerable to civil or criminal charges if the patient suffered harm from the treatment. The doctor could also be prosecuted for medical negligence.

Currently, it is common practice for doctors and hospitals to use a standardized printed format for consent forms across all medical procedures. However, it has been observed that blanket consent and the use of a single consent form for all the procedures are not legally valid. Failure to obtain proper consent can result in legal action and damages for the doctor or hospital.

To ensure compliance with legal requirements, doctors and hospitals should take the time to obtain informed consent from their patients. This means providing clear and concise information about the procedure, including risks and benefits, and allowing the patient to ask questions and make an informed decision. It is also important to tailor consent forms to each specific procedure to ensure that patients understand exactly what they are consenting to.

By following proper consent procedures, doctors and hospitals can protect themselves from legal liability and, more importantly, ensure that their patients are fully informed and involved in their medical care.

An example of such a case is as follows:

Dr Shyam Kumar vs Rameshbhai Harmanbhai Kachhiya on 31.07.2001: 2002 (1) CPR 320 (Guj State Commission) & National Consumer Disputes Redressal on 10 November 2005: I (2006) CPJ 16 NC.

A case was filed against Dr Shyam Kumar for compensation after he performed three consecutive operations without informing the patient about the reasons or what relief he could expect after each operation.

The Supreme Court in light of another case (Samira Kohli vs. Dr. Prabha Manchanda & Anr, January 16, 2008), summarized the following principles relating to consent:

• A doctor has to seek and secure the consent of the patient before commencing a ‘treatment’.
• The obtained consent should be real and valid, meaning the patient should have the capacity and competence to consent, and his consent should be voluntary.
• The patient’s consent should be based on adequate information about the nature of the treatment procedure so that he knows what he is consenting to.
• The doctor or a member of his team shall give ‘adequate information’ to the patient, which will enable him to make the correct judgement about whether to go ahead with his treatment.
• While taking the consent, the doctor should inform his patient about the nature and procedure of the treatment, its purpose, benefits, and effect, whether there is an alternative available, and an outline of the substantial risks, and adverse consequences of refusing the treatment.
• However, the doctor isn’t required to explain the remote or theoretical risks involved, as it can frighten or confuse his patient and may result in refusal of consent for necessary treatment.
• Similarly, there is no need to explain the remote or theoretical risks of not opting for a treatment, as it may persuade a patient to undergo unnecessary treatment.
• The possibility of the patient being deterred from agreeing to a necessary procedure or offering to undergo an unnecessary one should be greatly avoided. Hence, it is very important that doctors maintain an adequate balance between disclosing necessary and adequate information.

As healthcare professionals, it is your responsibility to ensure that patients receive a comprehensive and meaningful informed consent discussion prior to any medical procedure. This discussion should include information about the relevant risks, benefits, and alternatives of the proposed treatment, as well as the expected outcomes. Additionally, patients should be provided with ample opportunity to ask questions and receive clear, honest answers to their inquiries. Ultimately, by taking the time to have a thorough informed consent discussion, you can help ensure that your patients are well-informed and empowered to make the best decisions for their health and well-being.