What is informed consent

The doctrine of informed consent aims at giving sufficient information to a patient to enable him to make a knowledgeable and informed decision about the use of a drug, device or procedure in the course of treatment. The duty to warn a patient of any likely harm in the course of treatment has also been included in the doctrine.

(g) In order to conform to the doctrine of informed consent, the following conditions should be fulfilled:

(i) Disclosure of information

(ii) Free and voluntary decision-making by the patient

(iii) Patient is legally competent to decide

(h) The treating physician must ensure that the patient is explained the following in a language he / she understands:

(i) Provisional Diagnosis

(ii) Nature of procedure / treatment

(iii) Risks involved

(iv) Prospect of success

(v) Likely outcome in case the procedure is not performed

(vi) Alternative methods of treatment.

(j) Situations where consent is not required. Consent is not required to be obtained in the following situations:

(i) Medical emergencies: consent to emergency treatment is implied.

(ii) Treatment of notifiable diseases: in the interest of public health.

(iii) Medical examination under Sec 53, Cr PC.

(iv) Psychiatric examination / treatment by court order.

(k) Under Section 53 (1) of Cr P.C., a person can be examined at request of the police by use of force. Section 53 (2) lays down that whenever a female is to be examined, it shall be done only by or under the supervision of a female doctor.

(l) As far as possible, consent must be obtained from the patient, when he / she is competent to give it.

(m) Consent to treatment or a procedure or an operation is limited to the parameters that were expressed before the commencement of medical intervention. However in certain circumstances, extension of the scope of consent would be legally permissible. This principle of extension applies in cases of consent to treat an emergency.

(n) Consent should be obtained when procedure has finally been decided and planned and not while the investigation is still contemplated.

(o) Consent should be obtained in the presence of a witness before the pre-operative medication is administered and the same documented in writing.

(p) Only in situations where the patient is minor, unconscious or mentally unsound, consent should come from legal guardian/ NOK, who are present.

(q) In case of an unconscious patient, consent to emergency treatment is implied.

(r) Legally it is essential to take consent for the following reasons:

(i) It provides a practitioner legal protection in case of an action for negligence. The practitioner can cite proof of consent as evidence of disclosure, thereby protecting him from an action based on failure to disclose material facts.

(ii) Secondly, protection has been provided to practitioners who have obtained informed consent in accordance with the provisions of Sec 88, I.P.C.

(iii) Thirdly, it may be pertinent to note that exercise of reasonable skill and care is not sustainable in law as a defence against assault and battery.