Consent in medical practice means voluntary agreement, compliance or permission. Consent signifies acceptance by a person of the consequences of an act that is being carried out. To be legally valid, it must be given after understanding what it is given for, and of risks involved.
Reasons for obtaining consent in medical practice:
(1) To examine, treat or operate upon a patient without Consent is assault in law, even if it is beneficial and done in good faith. The patient may recover damages.
(2) If a doctor fails to give the required information to patient before asking for his consent to a particular operation or treatment, he may be charged for negligence.
Kinds of consent in medical practice: Consent may be : (1) Express, i.e, specifically stated by the patient, or (2) Implied. Express consent may be (a) verbal, or (b) written.
An adult patient of sound mind who (1) knows that he can either agree or refuse to submit to treatment or an operation, (2) knows or has been fully or fairly informed by his doctor as to what is to be done, and (3) then cooperated with the physician, has impliedly consented in words. The fact that a patient attends the hospital or calls the doctor to his house complaining of illness, implies that he consents to a general physical examination, to determine the nature of the illness. Consent is implied when a patient holds out his arm for an injection. Such implied consent is the consent usually given in routine practice.
Full Disclosure: The facts which a doctor must disclose depends on the normal practice in his community, and on the circumstances of the case. The doctor has to decide, after taking into consideration all aspects of the patient’s personality, physical and mental state, how much can be safely disclosed.
The doctor need not disclose risks of which he himself is unaware. A physician need not inform the patient of risks that a person of average intelligence would be aware of, or in an emergency situation. In general, the patient should ordinarily be told everything. The physician need not give information to those patients who waive their rights, but the waiver should be clearly written in the record.
Therapeutic privilege: This is an exception to the rule of “full disclosure”. Full disclosure of remote or theoretical risks involved could result in frightening a patient who is already fearful or who is an emotionally disturbed individual, and who may refuse the treatment when there is really little risk.
It is only in the case of frank psychosis or extreme psycho-neurosis that the patient will be incapable of accepting the information. In these cases, the doctor may use discretion as to the facts which he discloses. The doctor should carefully note his decision in the patient’s record, explaining his intentions and the reasons.
He should request a consultation to establish that the patient is emotionally disturbed. The presence of a malignancy, or an unavoidable fatal lesion may not be disclosed, if the doctor feels the patient is not able to tolerate the knowledge. If possible, the physician should explain the risks to the patient’s spouse or next of kin.
Prudent patient rule, i.e. what a prudent person in the patient’s position would have decided if adequately informed about all the reasonably foreseeable risks.
INFORMED consent in medical practice: Informed consent implies an understanding by the patient of
(1) the nature of his condition,
(2) the nature of the proposed treatment or procedure,
(3) expectations of the recommended treatment and the likelihood of success,
(4) the details of the alternative courses of treatment that are available,
(5) the risks and benefits involved in both the proposed and alternative procedure,
(6) the potential risks of not receiving treatment, and the relative chances of success or failure of both procedures,
(7) particular known inherent risks that are material to the informed decision, so that he may accept or reject the procedure.
All disclosures must be in language the patient can understand. Physicians have a legal, moral and ethical duty to provide all relevant information that enables a patient to either accept or reject treatment. This disclosure will very much reduce litigation, when the results are unsatisfactory or unexpected. The patient must show that the doctor did not adhere to accepted medical standards to prove liability for lack of informed consent.
Exceptions to informed consent in medical practice:
(2) Therapeutic privilege.
(3) When a patient waives his right to informed consent and delegates the right to the doctor or a close relative.
Informed Refusal: The physician has a duty to disclose adequately and appropriately to the patient, the risks or possible consequences of refusal to undergo a test or treatment. After understanding all the facts, the patient can refuse to submit to treatment or an operation.
Paternalism is an abuse of medical knowledge so as to distort the doctor-patient relationship in such a way that the patient is deprived of his autonomy, or of his ability to make a rational choice. This is seen in the context of disclosure to the patient.
RULES OF consent in medical practice:
(1) Consent is necessary for every medical examination. Ordinarily, formal consent to medical examination is not required, because the patient behaves in a manner which implies consent.
(2) Oral consent should be obtained in the presence of a disinterested third party, e.g., nurse.
(3) Written consent is not necessary in any case. However, it should be taken for proving the same in the Court if necessity arises. Written consent should refer to one specific procedure, and not blanket permission on admission to hospital. Written consent should be in proper form and suitably drafted for the circumstances. The consent form should include specific consent to the administration of a general anaesthetic. The nature of the operation should be entered on the form as precisely as is consistent with the best interests of the patients. The wording should include a phrase to confirm that the patient has been informed of the nature of the procedure, before signing takes place. The written consent should be witnessed by another person, present at the signing to prevent any allegation that the consent was forged or obtained under pressure or compulsion.
(4) Any procedure beyond routine physical examination, such as operation, blood transfusion, collection of blood, etc. requires express consent. It must be taken before the act, but not at the time of admission into the hospital.
(5) The doctor should explain the object of the examination to the patient, and patient should be informed that the findings will be included in a medical report.
(6) The doctor should inform the patient that he has right to refuse to submit to examination and that the result may go against him. If the patient refuses, he cannot be examined.
(7) The consent should be free, voluntary, clear, intelligent, informed, direct, and personal. There should be no fraud, misrepresentation of facts, undue influence, compulsion, threat of physical injury, death or other consequences.
(8) In criminal cases, the victim cannot be examined without his/her consent. The Court also cannot force a person to get medically examined, against his will. (A) In cases of rape, the victim should not be examined without written consent. (B) In medico-legal cases of pregnancy, delivery and abortion, the woman should not be examined without her consent.
(9) A person is arrested on a charge of committing an offence, and there may be reasons for believing that an examination of his person will provide evidence as to the commission of an offence. A registered medical practitioner can examine such person, even by using reasonable force, if the examination is requested by a police officer not below the rank of sub-inspector. If the accused refuses examination, this may go against him in criminal proceedings. (B) In the case of a female, the examination should be made only by or under the supervision of a female registered medical practitioner (S.53, Cr.P.C.). Under S.54, Cr.P.C. an arrested person at his request may be examined by a doctor to detect evidence in his favour.
(10) In cases of drunkenness, the person should not be examined and blood, urine, or breath should not be collected without his written consent. But, if the person becomes unconscious or incapable of giving consent, examination and treatment can be carried out. The consent of guardian or of relatives if available, should be taken. The person can be examined without consent, if requested by the sub- inspector of police.
(11) A person above 18 years of age can give valid consent to suffer any harm, which may result from an act not intended or not known to cause death or grievous hurt (Sec.87,I.P.C.).
A person may be suffering from a disease which is certain to shorten his life. He can give free and informed consent to take the risk of operation, which though fatal in the majority of cases is the only available treatment. The surgeon cannot be held responsible, if the patient dies.
(12) A person can give valid consent to suffer any harm which may result from an act, not intended or not known to cause death, done in good faith and for its benefit (Sec. 88, I.P.C.).
If a surgeon operates on a patient in good faith and for his benefit, even though the operation is a risk, he cannot be held responsible if the patient dies. The implication is that consent of parents or guardians is necessary for surgical or medical procedures if the patient is a minor.
(13) A child under 12 years of age and an insane person cannot give valid consent to suffer any harm which may result from an act done in good faith and for its benefit. The consent of the parent or guardian should be taken (Sec.89,I.P.C.). If they refuse, the doctor cannot treat the patient even to save the life.
A father giving consent in medical practice for an operation on the child in good faith and for the child’s benefit, even though the operation is risky, cannot be held responsible if the child dies.
Loco Parentis: In an emergency involving children, when their parents or guardians are not available, consent is taken from the person-in- charge of the child, e.g., a school teacher can give consent for treating a child who becomes sick during a picnic away from home town, or the consent of the headmaster of a residential school.
(14) A consent in medical practice given by a person under fear of injury, or due to misunderstanding of a fact is not valid. The consent given by an insane or intoxicated person, who is unable to understand the nature and consequences of that to which he gives his consent is invalid (Sec. 90, I.P.C.).
To represent to a patient that an operation is necessary to save life or to preserve health when that is not the case or to indicate that it will give greater relief than there is any reasonable prospect of obtaining is to perpetrate a fraud on the patient that vitiates his consent in medical practice.
(15) Any harm caused to a person in good faith, even without that person’s consent in medical practice is not an offence, 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 done in benefit (Sec. 92, I.P.C.). Nothing is said to be done in good faith which is done without due care and attention (S.52, I.P.C.).
A person may be involved in an accident, which may necessitate an amputation; if it is done without his consent in medical practice, it is not an offence i.e. In an emergency, the law implies consent. An emergency is defined as a medical situation, such as to render immediate treatment advisable either to save life or to safeguard health.
In an emergency, a comatose patient requiring immediate treatment, a mentally incompetent patient 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. A doctor may extend a procedure beyond the scope of consent to treat an emergency.
(16) Any communication made in good faith for the benefit of a person is not an offence, if it causes harm to that person to whom it is made (S.93, I.P.C.).
A physician in good faith tells a patient that he cannot live. The patient dies in consequence of the shock. The physician has not committed any offence.
(17) The doctor should inform reasonably to the patient about the nature, consequences and risks of the examination or operation before taking the consent in medical practice. In an obscure case, the doctor should obtain an open consent to use his discretion. When there are two or more methods of treatment, the patient should be allowed to choose and give consent for any method.
If in the course of an operation to which the patient has consented, the physician discovers conditions that had not been anticipated before the operation began, and which would endanger the life or health of the patient if not corrected; the doctor would be justified in extending the operation to correct them, even though no express consent was obtained. If an anaesthetist administers a type of anaesthetic expressly prohibited by the patient, he will be responsible for damages resulting from an unfortunate occurrence caused by the anaesthetic, even though there is no negligence in its administration.
(18) Consent in medical practice of the inmates of the hostel, etc., is necessary if they are above 12 years. Within 12 years, the head master or warden can give consent. If an inmate above 12 years refuses treatment, and he is likely to spread the disease, he can be asked to leave the hostel. However, if he stays in hostel, he can be treated without his consent.
(19) When an operation is made compulsory by law, e.g., vaccination, the law provides the consent.
(20) A prisoner can be treated forcibly without consent in the interest of the society.
(21) Consent in medical practice given for committing a crime or an illegal act, such as criminal abortion is invalid.
(22) Consent is not a defence in cases of professional negligence.
(23) The nature of illness of a patient should not be disclosed to any third party without the consent of the patient.
(24) For contraceptive sterilisation, consent in medical practiceof both the husband and wife should be obtained.
(25) The consent of one spouse is not necessary for an operation or treatment of other. A husband has no right to refuse consent in medical practice to any operation, including a gynaecological operation, which is required to safeguard the health of his wife. The consent of wife is enough. It is advisable to take the consent of the spouse whenever practicable, especially if the operation involves danger to life, may destroy or limit sex functions, or may result in the death of an unborn child.
(26) It is unlawful to detain an adult patient in hospital against his will. If a patient demands discharge against medical advice, this should be recorded and his signature obtained.
(27) A living adult person can give consent in medical practice for donating one of his kidneys to be grafted into another person. The donor must be informed of the procedure involved and possible risks. The donation should not be accepted, if there is any risk of life of donor.
(28) If any person has donated his eyes to be used for therapeutic purpose after his death, the eyes can be removed only with the consent of guardian or legal heirs.
(29) If any person has donated his body to be used for therapeutic or research purposes after his death, it is not binding on his spouse or next of kin. For organ transplantation, the organs of the dead person, such as heart, kidney, liver, etc. should not be removed without the consent in medical practice of the guardian or legal heirs. Precautions should be taken to preserve the anonymity of both donor and recipient.
(30) Pathological autopsy should not be conducted without the consent of the guardian or legal heirs of the deceased. If the autopsy is done without consent, the doctor is liable for damages for the mental anguish suffered by heirs due to the mutilation of the body. Specific authorisation should be obtained for retention of organs and parts of the body. In medico-legal autopsies (statutory authorisation), consent in medical practice is not required and the doctor can remove from the cadaver anything that is essential for purposes of examination.
CASE: (1) MOSS V. RISHWORTH: A 11 year old girl was taken to surgeon for removal of tonsils and adenoids by her two adult sisters. The child died under anaesthetic. The Court held that there was no emergency which would excuse the need for parental consent, and the father could recover damages.
(2) JOCKOVACH V. YOCUM: The arm of a 7 year old boy was crushed by a train. The boy’s arm was amputated immediately as the doctors could not contact parents. The consent in medical practice of the parents was implied by the emergency.
(3) WELLS V. MC GEHEE: A 7 year old child died under anaesthesia for treatment of a broken arm, which was given without the consent of the mother as she could not be contacted. The Court held that an emergency existed.
(4) DRUMMOND’S CASE: Drummond sued a woman patient for recovery of fees. The patient counterclaimed damages as a drug was administered to her, without her consent in medical practice. She alleged that phenobarbitone, which she refused to take, was mixed in soup and meat and given to her daily, which prolonged her stay in the nursing home, as a psychological consequence for 16 weeks. The Court held that the administration of a drug to a person without that person’s knowledge and consent was assault, and awarded nominal damages as the drug did not cause substantial harm.