In medical practice, consent is a legal requirement, not a procedural formality. Getting a mere signature by the patient on a form is not consent. If a patient signs the consent form without getting sufficient information, then the consent is treated as invalid. The element of consent is very crucial in medical treatment. The patient has the legal right under article 21 of the constitution of India for the self-determination. The consent should be obtained only after providing the necessary and sufficient information about the treatment and medication. The patient has a right to decline or refuse the treatment given by the doctor, but in case of emergency, the doctor need not take the consent for treatment, raising the debate on medical malpractices. A doctor who treats without valid consent will be liable under tort and criminal laws. Most often, medical practitioners ignore the requirement of valid consent and its legal implication resulting in the scrutiny in various medical malpractice cases.
Law Of Consent In INDIA
Article 21 of the Indian constitution deals with the right to life and liberty. Article 21 has the widest amplitude as it covers a wide variety of rights, including the right to live with dignity and includes any act which injures, damages or interferes with the use of any limb or faculty either permanently or temporarily.
The concept and scope of informed consent are one of the most critical and highly debated issues in medical treatment in India. As per the verdict laid by the Supreme Court in Samira Kohli vs Dr Prabha Manchanda and Another (2008) 2 SCC 1, concerning the context of the relationship between doctor and patient, the consent is defined as the permission by a patient for an act to be carried out by a doctor for treatment. The Medical Council of India (MCI) states that ‘a physician, before performing an operation, should obtain the consent in written form from the parents, husband or wife, or guardian in the case of a minor, or the patient himself as the case may be. Otherwise, it shall constitute professional misconduct on the part of the physician rendering him/her liable for disciplinary action by MCI.
The doctor must give proper and adequate information to the patient to understand the aspects of the treatment given to him. The necessary information may include the following things:
- Nature of the treatment
- The procedure of the treatment
- Purpose and benefits
- Complications that may arise
- Alternatives for the effects
- Outline of substantial risk in treatment
- Adverse consequences of refusing treatment.
The adequate information given by the doctor need not include remote risks, rare complications and possible results of a hypothetical negligent surgery. Before commencing treatment or surgery, the consent obtained by the doctor should be real and valid, which states that:-
- The patient should have the competence and capacity to consent;
- The consent given by the patient should be voluntary;
- Also, the consent given should be based on adequate information concerning the nature of the treatment and procedure.
Patient information sheets (PIS) should maintain the information related to the procedure, including pre-operative and post-operative pre-cautions in the simple language with graphic representation may aid the versed consent process. While handing the PIS to the patient, the contents should be explained to him.
The consent form may include the following:
- Date and time
- Details of the patient, including the name, age and signature of the patient.
- Details of doctors mentioning the name, registration number and signature of the doctor
- Name and signature of a witness
- Type of Disease
- Surgical procedure
- Type and nature of the surgery
- Type of Anaesthesia
- Blood transfusion
- Document the fact that patient and relatives were allowed to ask questions, and their queries were answered to their satisfaction.