Informed Consent and Medical Negligence

INFORMED CONSENT AND MEDICAL NEGLIGENCE

 INTRODUCTION

There has been a definite increase in the number of suits that have arisen because of lack of consent or inadequate consent from the patients for various procedures. This is due to significant changes in the doctor patient relationship with the impact of technology in day-to-day practice. More and more patients are aware of their rights and are keen to make free choice and decision on their treatment A lot of remedial work needs to be done to minimize future litigation, as many doctors misunderstand their legal obligations and haven’t caught up with the change in judge’s thinking It is seen that there is lack of knowledge and not enough awareness of the legal and ethical requirements and clinical aspects of consent in Medicine in India. This paper discusses the ethical, legal and clinical aspects of informed consent. 

INITIAL APPROACH TOWARDS CONSENT 

The traditional doctor-patient relationship and its medical ethical principle required that the physician do what he thought would benefit the patient. Traditional doctor-patient relationship was one in which the doctor and the patient were unequal bargaining partners in a contract for services with the doctors special knowledge creating the advantage. The principle of mutual trust protected these decisions. The medical profession even refused to recognize the wishes of the patient and felt that he knows what is best for the patient – a paternalistic attitude. The physicians failed to accept that the patient is entitled to make his own free choice and decision the principle of autonomy. 

CHANGE IN APPROACH 

The change in environment and awareness of rights of patients has eroded the old model. The emerging model prefers to treat a doctor as a service provider for hire, governed by negotiation and a commercial relationship. The patient today, chooses to have the ability to select and dismiss their doctors. They have the resources and can express their preferences about making decisions on general or even specific treatments. They prefer to ask questions, reject proposals offered by the doctors based on their own personal opinion. The clinical-ethical process of shared decision-making is mirrored by the legal doctrine of Informed Consent.(IC) Informed consent is meant to force the doctor to give the patient the knowledge that will make him an equal bargaining partner. Thus informed consent is meant to transform the essence of the doctor-patient relationship to a contractual one as contractual relationships are thought to promote individual autonomy and freedom of choice.

 MEANING OF INFORMED CONSENT 

Informed consent is defined as voluntary acceptance by a competent patient of a plan for medical care after the doctor adequately discloses the proposed plan, its risks and benefits, and alternative approaches and options that the patient has.Informed consent needs to meet two essential requirements, firstly it needs to be free and voluntary and secondly it needs to be based on adequate reasonable information and disclosure made by the doctor.

Consent is said to be free when it is not caused by coercion, undue influence, fraud, misinterpretation or mistake. The consent must be to do a lawful act and it must not disobey any provision of the law. A Consent would be referred to as informed if it is given by a person after receipt of the following information: the nature and purpose of the proposed procedure or treatment; the expected outcome and the likelihood of success; the risks; the alternatives to the procedure and supporting information regarding those alternatives; and the effect of no treatment or procedure, including the effect on the prognosis and the material risks associated with no treatment. Also included are instructions concerning what should be done if the procedure turns out to be harmful or unsuccessful.

Common meaning of consent is permission whereas the law perceives it as a contract i.e. an agreement enforceable by law. In consent there are four separate but correlated elements that are: voluntary ness, capacity, knowledge and decision-making. Voluntary ness suggests willingness of patient to undergo treatment. Capacity means a degree of ability of the patient to understand the nature and consequences of the treatment offered. Knowledge means that sufficient amount of information about the nature and consequence of the treatment has been disclosed to the patient. Decision-making means the ability to take decisions regarding consent. To be legally valid all these elements must be present in the consent. 

TYPES OF CONSENT

Consent can be three types namely implied, expressed or presumed.

 When a patient approaches a doctor an implied consent is there for taking history, general physical examination etc which would enable the doctor to treat the patient.

An expressed consent can be written or oral. This type of consent is taken if there is no implied consent or when any material risk is involved. Expressed consent includes informed consent, which is the ideal form of consent because it includes all aspects of meaningful decision-making. Expressed consent can be oral and verbal.

Oral consent is generally taken for some specific medical procedures like injecting medication, drawing blood for pathological examination, gynecological examinations etc. Oral consent can be proved in court if it was taken in the presence of witnesses or if the doctor records in the case record of the patient that oral consent was taken.

Written consent is taken for major medical procedures and surgery. Written consent to undergo medical treatment and forms the best defence for a doctor to evade criminal liability.

Further, the code of medical ethics laid down by the Medical Council of India (approved by the Central Government under section 33 of Indian Medical Council Act, 1956) contains a chapter relating to disciplinary action which enumerates a list of responsibilities, violation of which will be professional misconduct. Clause 13 of the said chapter places the following responsibility on a doctor to obtain expressed consent (in writing).
“13. Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of a minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed.”

 Presumed consent is important in cases of emergency when consent cannot be taken. Another example of presumed consent as practiced in some countries (U.S.A., Spain and France) is in postmortem cases where unless there is a pre-recorded objection or an intimation of objection from the next of kin of deceased prior to death, corneas can be removed for transplantation. Presumed consent allows the removal of organs, unless the decedent has opted out or the family objects i.e. unless there is a pre-recorded objection or an intimation of objection from the next of the kin of the deceased.  

LEGAL ISSUES INVOLVED WITH CONSENT

AGE AT WHICH VALID CONSENT CAN BE GIVEN 

Unlike India, many countries have legislated age for giving valid consent for medical examination and procedures.

S.90 of the Indian Penal Code provides ‘Consent by intoxicated person, person of unsound mind or a person below twelve years of age is invalid’. By implication from Section 90 IPC, one can say that in general a boy or girl can consent to medical or surgical treatment if he or she is above twelve years of age provided the treatment is intended for his or her benefit and is undertaken in good faith. Thus going by this school of thought a doctor cannot be held criminally liable if a person above 12 yrs has consented to undergo the treatment suggested by him.

Another school of thought however feels that valid consent can only be given at or above eighteen years of age. They feel that consent is a contract between two parties and as the Indian Contract Act states that to enter into a contract both parties must be at least eighteen years of age, this should be the age for giving valid consent in medicine. However the Indian Contract Act does not specifically applies to medicine.

In the absence of clear cut legislation in this regard majority of doctors consider the consent of a person above twelve and less than eighteen years valid for medical examination only and for medical procedures prefer to take the consent of the parents/guardians. They feel this will be of benefit in cases involving civil liability. To resolve this matter legislation should be passed specifying age for giving valid medical consent, as has been done in other countries, so that arbitrariness can be done away with and legal problems avoided.

COMPETENCE

Capacity to give valid consent is an essential consent is an essential element of Informed Consent. The aspect of age at which valid consent can be given to undergo a specific medical treatment has been discussed above. However there are several other factors that determine the competence of a person.

The ethical dimension of informed consent encourages respect for individual autonomy in medical decision-making. There are however conditions that substantially limit autonomy and therefore also autonomous choice. People with a learning disability or a mental or physical illness may be temporarily incapacitated to make autonomous choices due to their condition. In these cases the concepts of capacity and competence become paramount in determining the extent to which a person’s autonomy is restricted and whether that person can give a valid consent.

 Competence is a legal term, and courts decide on the competence of a person based on the inputs provided to it by the doctors who give an opinion on the capacity of the patient The disability should materially incapacitate the person to comprehend facts and make independent decisions.

Some psychiatric disorders can impair decision-making functions to some extent, but not to the point where patients would be considered legally incompetent. In such cases, clinicians can make disclosure in a manner that takes patients’ limitations into account which may include simplifying elements of the disclosure, offering information in smaller amounts stretched out over time, and repeating disclosure several times.

EXCEPTION TO CONSENT

a. Doctrine of Emergency: In medical emergencies consent need not be obtained if circumstances are such that it is impossible for that person to give consent.

Under section 92 of Indian Penal Code (IPC) treating without consent of patient is permissible if patient is unconscious, mentally ill or gravely sick. When the time required for disclosure would create a substantial risk of harm to the patient or third parties, full disclosure requirements may not apply. It is implied that the procedure / surgery is done to save the life or limb of the patient. If possible, surrogate/proxy consent should be taken.

b. Waiver: Patients may waive their rights to receive information. This should be a knowledgeable and informed waiver, i.e. patients should be made aware that they have a right to receive the information, to designate a surrogate to receive the information, or to be informed at a later date.

  In emotionally disturbed patients the doctor should request a specialist consultation to establish that the patient is emotionally disturbed. The procedure requires the doctor to make a note of their withholding the information and the reason for doing so.

d. Incompetence: This exception to informed consent had been discussed in detail above. Incompetent patients may not, as a matter of law, give an informed consent as they do not possess the capacity to fully understand and comprehend the situation so as to enable them to make a reasonable decision. State law generally provides alternative mechanisms by which consent can be obtained, and requires disclosure to a substitute decision-maker. Procedure requires that when a person is incapable of giving expressed consent a substituted consent can be taken from the next of kin. Generally accepted order is spouse, adult child, parents, siblings, and lawful guardian.

e. Involuntary treatment: Psychiatric treatment is allowed to be carried on without patients’ informed consent. This occurs most commonly when patients’ refusals of treatment are specifically overridden following clinical, administrative, or judicial review.

f. It is important to appreciate that in a particular situation such as court ordered evaluations for competency to stand trial, consent is not required. In such a case a psychiatrist should inform the subject and explain that the evaluation is legally required and if the subject refuses to participate in the evaluation this fact will be included in any report or testimony. An arrested person can be examined without consent if requested to do so by a police officer not below the rank of a Sub-Inspector (Section 53 IPC).

g. Consent of one spouse is not necessary for an operation (including MTP) or treatment of another. For contraceptive sterilization consent of both husband and wife should be taken.

 

 

 

 

 

[1] (1) Stone AA. Informed Consent. Special Problems for Psychiatry. Hospital and Community Psychiatry. 1979; 80(5): 321-7