Section 10 in West Bengal Clinical Establishment (Registration, Regulation and Transparency), Rules, 2017
10. Counseling and informed Consent.
(1)Under clause (c) of sub-section (2) of section 7 of the Act, the clinical establishment shall ensure the right of patient mentioned in sub-rule (2).(2)The patient shall have the right to a clear, truthful and substantial explanation, in the form of a counselling in a manner and language understandable to the patient, of all proposed healthcare intervention or procedure, wherein the person intends to perform such procedure or administer such intervention shall provide the following information as a part of such counselling: (a) her name and credentials to the patient; (b) possibilities of any risk of mortality or serious side effects; (c) problems related to recuperation; (d) probability of success and reasonable risks involved; (e) alternative healthcare intervention available; and (f) medical consequence of refusal etc.(3)No patient shall be subjected to any healthcare intervention without her written informed consent, except in the following cases:(a)in emergency cases, when the patient is at imminent risk of physical injury, decline or death if such intervention or procedure is withheld or postponed; or(b)when the health of the population is dependent on the adoption of a public health program; or(c)when the law makes it compulsory for everyone to submit to a healthcare intervention; or(d)when the patient is incapable of giving consent because she is of under-age, or is unconscious or is in a state of mind constituting a mental impairment; or(e)when disclosure of material information to patient may jeopardize the success of treatment, in which case, third party disclosure and consent shall be in order; or(f)when the patient waives her right in writing.(4)Informed consent shall ordinarily be obtained from a patient concerned if he/she is of legal age, conscious and of sound mind in a consent form printed or written in a language understandable by all the signatories bearing all relevant particulars like clinical establishment's name and License number and any such particulars as may be notified.(5)If the patient is incapable of giving consent because he/she is of under-age, or is unconscious or is in a state of mind constituting a mental impairment a third party consent shall be required wherein the following member of the patient party, in the order of priority stated hereunder, may give such consent: (a) spouse; (b) son or daughter of legal age; (c) either parent; (d) brother or sister of legal age, (e) guardian, or (f) any near relative or any one of the patient party.(6)Proper Counselling shall precede the signing of the consent form particularly in such cases that may involve surgical healthcare intervention that are difficult to reverse or involving removal of organs, sterilization or amputation of limbs.
