Taking patient’s consent is a doctor’s legal and ethical obligation. Patient consent must be voluntary and informed and can be implicit or explicit. It is a fundamental acknowledgement of patients' autonomy and freedom of choice. Consent given and taken appropriately enhances and strengthens the doctor-patient trust. It is legally obligatory in India to obtain written informed consent of the patient for every medical intervention.

To clear doubts and uncertainties on the various legal aspects of patients consent and to reduce medical errors and the legal issues arising out of improper consent The Pacemakers will publish a series of blogs on Patients Consent.The content of this series has been taken from "SOP on Patients Consent",a comprehensive and legally compliant document on patients consent in India which is outcome of a unique collaborative deliberation done every year by a large number of doctors, hospitals, and medical societies. This SOP is annually reviewed and updated as both law and medicine are dynamic and keep on changing.A first of its kind in the world, it is initiated and facilitated by the Institute of Medicine & Law (IML).

SOP on Patients Consent 2023 series (Part-2) - 

This blog deals with ideal Consent before any Surgery/ Procedure/ Intervention-

01. Do not take 'blanket' consent, general in nature, at the time of admitting a patient for surgery / procedure. A ‘blanket’ consent means and includes taking consent of patient on consent forms that are half-filled or not filled at all.

02. Take consent closer to the day of the surgery / procedure. (Advisable)

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03. Disclose to the patient during pre-surgery counseling and record specifically in the consent if:
i. Any decision may have to be taken on the operation table after starting the surgery / procedure - Even if it is the choice of not proceeding further after opening such as in the cases of advanced cancer or tuberculosis.
ii. Damage / removal of important organs is a possibility.
iii. Any other alternative/s may have to be adopted after opening the patient. Record specifically all such alternatives.
iv. The surgery / procedure may require multiple stages / sessions / sittings
v. Corrective surgery / procedure may be required to deal with known post-surgery complication/s.
vi. Re-operation / second intervention may be needed.
vii. Relapse / recurrence / failure is a known possibility of that particular surgery / procedure.
viii. Any part / tissue / fluid / organ removed from the patient's body would be sent for cytological or histopathological examination.

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04. Record the date fixed for performing a scheduled, non-emergency elective surgery / procedure in the consent.

05. No fresh consent is required if the surgery / procedure is rescheduled but without any change to whatever was originally consented by the patient. However, if the surgery is postponed by more than 48 hours, contemplate of taking a fresh consent or just add a line below the already signed consent validating it on the current date by signing afresh (Advisable).

06. Take composite consent for both the surgery / procedure and re-exploration, if foreseeable and anticipated.Take fresh consent for non-emergency re-exploration / repeat intervention to correct complications suffered by the patient during / after the course of treatment / intervention.

07. Take separate consent for each procedure / surgery if two or more surgeries / procedures are to be performed together either by the same surgeon or by different ones.

08. Take separate and specific consent for each and every foreseeable and anticipated alternative surgery / procedure. Consent for a difficult / complicated surgery / procedure does not automatically operate as consent for a comparatively easier / simpler alternative. Additional / alternative / extension that may have to be performed during the course of a surgery / procedure is not intended to be covered by this clause.

09.Take 'high-risk consent in appropriate cases. Inform the patient / attendants accordingly and record the said fact specifically in the medical records also.

10. Anesthesia :
i. Take separate specific consent for anesthesia.
ii. Duly record the type of anesthesia - general / local / epidural / spinal / nerve block or any other in consent.
iii. Take advance consent for each option if multiple anesthesia options are contemplated in alternative.
iv. Follow other protocols / procedures of general consent as far as possible which are applicable / relevant to anesthesia.
v. The anesthetist should also sign this consent form.

11. Record specifically name of the principal surgeon and the principal anaesthetist in both, the consent for surgery as well as the consent for anaesthesia.

12. Take a fresh consent if the doctor scheduled to perform a surgery / procedure for whom the patient had specifically consented is changed.

13. Non-availability of the surgeon for post-surgery care especially when the surgeon has agreed only to perform the surgery / procedure and thereafter the day-to-day management would be the responsibility of others or of another designated doctor or a team of doctors:
i. Inform the patient in advance of the aforesaid, and record it specifically in the consent. Emergencies are exceptions as far as informing the patient is concerned.
ii. Provide proper substitute even in an emergency not anticipated by the surgeon.
iii. This clause will not apply to public hospitals / 'group practice'.

14. Confirm before starting every surgery / procedure whether the OT nurse has personally checked the consent form/s in the patient's medical records that it is signed by the patient / doctor / witnesses and complete in all respects.

15. In case of an accidental injury / mishap / complication during a surgery / procedure follow the protocol, as far as applicable.

16. Do not take separate consent for sending any part / tissue / fluid / organ removed from the patient's body for usual cytological histopathological examination. But sending it forresearch purpose requires separate specific consent as per ICMR guidelines.

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Additional / Alternative / Extension During a Planned Surgery / Procedure (same anesthesia period)

01. Discuss, explain and take specific consent beforehand for any additional / alternative / extension that may have to be performed during a planned surgery / procedure when the patient would be unable to take an informed decision.

02. Record specifically the names of each of the anticipated and foreseeable additional / alternative / extension in the consent.

03.  Additional / alternative / extension during the course of a surgery / procedure without thepatient’s specific consent-
i. Do not proceed without specific consent only because it would be beneficial to the patient, or would save considerable time and expense of the patient, or relieve the patient from pain and suffering in future.
ii. Proceed only if it is ‘necessary in order to save the life, limb or organ, or preserve the health of the patient and it would be unreasonable to delay’.
iii. Take written consent, if possible, from the patient’s attendants (Advisable).
iv. Record specifically and elaborately the reason/s for the additional / alternative /extension in the intra-surgery notes and in the written consent taken from the patient’sattendants(if one has been taken)