Consent is an expression of autonomy and represents the right of a patient to make a decision in a medical matter concerning him. Consent is not just a procedural formality but also a legal requirement. The process of informed consent occurs when communication between a patient and physician results in the patient’s authorization or agreement to undergo a specific medical intervention. In India, the number of suits against doctors is increasing because of failure to take informed consent or inadequate consent from patients for various procedures. Any examination of a patient by the doctor without his consent amounts to assault (351IPC). Ignorance of laws is not a defense in negligence cases, so every practicing doctor should be aware of their responsibilities about consent in medical practice. Consent is not an option but a necessity in medical practice.
The origin of the word consent is from the French word consente and Latin word consentire, which means co-together+sentire feel. Consent implies agreement to accept the consequences of an action. Legally, two or more persons are said to consent when they agree upon the same thing in the same sense.
The demeanor, behavior and actions of the patient indicate his consent. Trust and empathy from the basis of implied consent and are limited to inspection, palpation, percussion, auscultation except private parts in a standard professional
In expressed consent, a patient specifically permits a physician to undertake diagnosis and treatment of a specific problem. An expressed consent can be written or verbal. Verbal consent is also legally valid but in a court of law, it may face a problem of credibility more so in cases where the patient has died. Expressed consent conforms to the doctrine of informed consent to be legally acceptable.
Examining or treating a patient without his consent amounts to assault.
Consent respects the principle of biomedical ethics
Consent shows respect for the privacy and dignity of his patient
Consent protects legal action in case of medical negligence as this acts as proof of disclosure of material facts
Protection has been provided to doctors as per sec 88 IPC who have obtained informed consent which states ‘act not intended to cause death, done by consent in good faith for person’s benefit
Consent must be obtained before treatment begins. It should be confirmed at the time of procedure.
For changes in treatment (introducing a different type of technique), the full process of informed consent must be undertaken and consent explicitly obtained verbally or in writing. The patient should also be made aware that this ongoing consent (voluntarily) can be withheld at any point of time during treatment or procedure.
A person of sound mind should give it.
It should be based on correct and adequate information
It should not have been obtained by fraudulent means
In situations of a medical emergency, consent to life-saving measures is implied.
A person who is legally competent to give it.
Information to disclose to the patient include
The patient’s diagnosis
The nature and purpose of a proposed treatment or procedure
The risks and benefits of a proposed treatment or procedure
Alternatives and associated risks and benefits
The risks and benefits of not receiving or undergoing a treatment or procedure
The special precautions required postoperatively
Questions asked by patient and explanation provided
A patient has to be given full opportunity to decide a medical matter concerning him. Consent that is given must be intelligent, informed and voluntary, the decision taken freely by the patient himself.
Informed consent has to be given by a person who meets the following criteria
He/She should be sound mind
He/She should be able to comprehend the implications of his consent
He/She should be at least twelve years old.
Doctor taking a decision on the type of treatment based on medical facts without the patient's input and participation which is against the principle of respect for the person and patient autonomy.
As per Section 90 of IPC, if any consent given under the following circumstances will not be true consent.
By a person under fear of injury or,
By a person who is under the misconception of the facts and person who obtain consent knows or has reason to believe that or consent was given in consequence of such fear/misconception.
By intoxicated person or,
By a person who is of unsound mind or, unable to understand the nature and consequences of that to which he gives consent.
By a person who is below the age of 12 yrs.
If after knowing about the procedure, its side effects, and other information related to the procedure patient declines or refuses to undergo the procedure, it must be taken in written. Treatment cannot be forced upon any individual who does not want to receive it, except in a very few circumstances like issues associated with public health, military personnel, or prisoners.
Therapeutic privilege
Emergency life-threatening situation
It is an exception to the rule of full disclosure that a doctor can withhold information of remote or theoretical risks if he/she feels that it would be psychologically damaging or harm the patient if disclosed and who may refuse treatment when there are little risks.
As per sec.92 IPC any harm caused to a person in good faith even without that person's consent is no offense if the circumstances are such that it is impossible for that person to signify consent and has no guardian or other person in lawful charge of him from whom it is possible to obtain consent in time for the thing to be in benefit.
In an emergency, a comatose patient requiring immediate treatment, the mentally ill person requiring treatment when a legal guardian is not available, an intoxicated patient who temporarily lacks the capacity to consent but requires treatment consent is implied.
Sec 87 I.P.C. - A person under the age of 18 years cannot give valid consent, whether expressed or implied, to suffer any harm which may result from an act not intended or not known to cause death or grievous hurt.
Sec 89 I.P.C. - a child under 12 years of age cannot give valid consent to suffer any harm which can occur from an act done in good faith and for its benefit, e.g. consent for an operation. Only a guardian can give such a consent
Under section 375 I.P.C. –Sexual intercourse with or without the complainant's consent when such complainant is under eighteen years of age amounts to sexual assault.
As per The Transplantation of Human Organs Act1994 and transplantation of human organ act(amendment ) act 2011, Donor means any person not less than eighteen years of age, who voluntarily authorizes the removal of any of his human organs for therapeutic purposes. For cadaver donor transplants, informed consent from the next of kin should be taken. If prior consent for organ donation before death is given in the presence of two or more witnesses, then transplantation of the organ should be presumed and is permissible without seeking further consent.
Consent of one spouse is not necessary for the treatment of another. The spouse has no right whatsoever to withhold consent to any operation including gynaecological operations which is essential to safeguard the health of the other spouse. However, it is essential that spousal consent should be taken where there is a possibility of treatment-induced complication of sterility or impotence which affect the marital rights of either spouse are involved.
As per the MTP ACT 1971, does not require spousal consent for MTP, presuming that the husband has no legal right to participate in question concerning the pregnancy of his wife. In Assisted Reproductive Technologies informed consent should be taken from the spouses as well as the donor, as the case may be, for possible side effects, and the risk of treatment.
As per the Delhi Artificial Insemination Act 1995, written consent of both husband and wife seeking artificial insemination and also consent for single screen semen for HIV through enzyme-linked immunosorbent assay (ELISA) should be taken.
They can be admitted or treated or discharged from a psychiatric hospital as per the guidelines laid in Indian Mental Health Act 1987
When an unconscious /unknown patient is admitted to the hospital, the medical superintendant/incharge of hospital can give consent for treatment. Consent of deceased relatives is required for conducting the pathological autopsy. In medico legal autopsy, consent is not required by guardians or legal heirs.
All the radiological investigations which involve isotopes, dyes, or other image enhancers and treatment by chemotherapy and radiotherapy should involve consent for treatment after proper disclosure of side effects and further disabilities.
Research studies or clinical trials should be conducted and have informed consent as per the guidelines laid by the Indian Council of Medical Research.
Informed consent was practically non-existent the time COPRA (Consumer Protection Act) came into existence. This is seen as more of a legal requirement than the moral obligation on the part of the doctor towards his patient. Consent should be taken before the commencement of the Procedure and not during the course of the procedure. Consent should be procedure-specific and blanket consent is not valid. The patient has the legal and moral right to withdraw the consent during the course of the procedure. Fresh consent should be taken for repeat procedures including the reexplorartion procedure. Consent given for illegal procedures is invalid.
It is therefore necessary for treating doctor to provide all necessary information to the patient before commencing the procedure and this communication should be documented. In the event of an adverse medical outcome, written records of discussion can be doctor’s best defense as the court can demand relevant documents of the patient. Even professional indemnity insurance may not cover failure to take valid consent considering it is an intentional assault.