Obtaining a written informed consent from the patient for every intervention and blood transfusion is a doctor’s legal and ethical obligation. Patient consent must be voluntary, free, and informed. It may be implicit or explicit, and it fundamentally acknowledges the patient's autonomy and right to make choices about their care.

When obtained appropriately through effective communication, meaningful informed consent promotes better patient understanding and health literacy, enables shared decision-making and expectation management, prevents avoidable harm, and strengthens trust between the doctor and the patient.

This SOP is in the form of a set of instructions – simple Do’s and Don’ts for healthcare providers. Its purpose is to protect patients' rights, uphold ethical standards in medical practice, and ensure legal compliance. It aims to establish a simple, clear, and legally acceptable process for obtaining informed consent and to standardise communication and documentation.

This SOP applies to all healthcare professionals involved in patient care, including doctors, nurses, and hospital administrators. It covers elective, emergency, minor, major, and high-risk interventions.

Take consent only of the patient in a non-emergency situation if the patient is an adult (also refer to Clause 6.1), competent (also refer to Clause 6.5), conscious and oriented (to time, place, and person). Establish, confirm, and record mental competence (compos mentis) of all adult patients irrespective of their age. Do not consider older / elderly / mentally ill / visually impaired patients incompetent by default. Assess and document their capacity to consent. Ascertain whether incompetence is temporary / reversible (e.g. sedation / intoxication) or permanent / irreversible and in case of temporary / reversible incompetence take efforts to obtain consent after reversal. In appropriate cases, especially high-risk cases (also refer to Clause 1.18), signature of witness / es (also refer to Clause 1.19) may also be taken (Advisable).

Take ‘proxy’ consent from competent adults responsible for incompetent patients. (also refer to – ‘Chapter 6. Minors / Incompetent / Emergency patients – Proxy Consent’). Any person authorized by the patient can also give proxy consent for that patient in accordance with his / her Advance Medical Directive (AMD) as prescribed by the Supreme Court. In appropriate cases, signature of witness/es (also refer to Clause 1.19) may also be taken (Advisable).

Do not take consent of spouse, children, or parents (instead of the patient) of an adult, competent, conscious and oriented patient. However, they may be asked to sign as witnesses (also refer to Clause 1.19), especially in high risk cases, very old / elderly patients, and so on (Advisable).

Take consent of both the spouses in case of a legally married patient undergoing Assisted Reproductive Technology (ART) Procedure. Record specifically the marital status of the patient.

Take patient's written consent rather than not taking one (Advisable). When in doubt, in a dilemma, or in an obvious conflict regarding the need for taking  written consent, involve senior consultants, hospital administrators, and / or the Medical Director / Superintendent and seek their advice (Advisable).

Take written consent for those investigations / diagnostics and therapeutic procedures, whether major or minor, whether in IPD or OPD settings, that require invasive intervention and are not routine. OPD procedures are not necessarily exempt from written consent. Take written consent (advisable, not mandatory) for certain non-invasive therapeutic measures such as diathermy, lithotripsy, nuclear-scan, CT scan with contrast, BiPAP, chemotherapy, radiotherapy, hormone replacement therapy, drugs having serious side-effects, high risk medication, high dose steroids, immunosuppressants, and such other high-risk cases (also refer to Clause 1.18). Take specific written consent of the patient before performing HIV / AIDS investigations as prescribed by the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 (also refer to – ‘Chapter 18. Consent for HIV Test’). Take specific written consent for therapies / interventions that can potentially cause serious morbidity or end-organ dysfunction.

Implied consent refers to consent that is not expressed in words, spoken or written, but is inferred from the patient’s actions, behaviour, or the circumstances indicating their willingness to undergo treatment / intervention. Specific written consent is generally not required:
i. For routine investigations such as drawing of blood.
ii. From OPD patients on routine visits, unless an invasive procedure has to be performed in the OPD.
iii. For non-invasive diagnostic / therapeutic procedures such as ECG, USG, plain CT scan, and so on. CT scan using contrast dye and on pregnant women will require consent.
iv. For routine post-operative procedures such as removing drain, sutures / staples removal, and so on.

Do not reduce consent to a mechanical / routine act. Consent is a process and not merely an act of signing the consent form. It involves providing relevant information about the proposed treatment / intervention (also refer to Clause 1.14), discussing with the patient, arriving at a mutual agreement, and then filling and signing the consent form. Provide information that is relevant to that particular patient, in a comprehensible manner, regarding his/her general health status, social and financial implications, and which will help the patient to make an informed and independent choice.

Do not materially deviate from what has been consented and agreed, except in life-threatening / emergency conditions (also refer to Chapter 8: Additional / Alternative / Extension during a planned surgery / procedure).

Take consent only after appropriate disclosures and proper explanation, neither by unduly scaring nor falsely alluring the patient into acceptance. Follow guidelines on counselling, if any, issued / framed by national medical associations for that particular therapy / intervention. Encourage the patient to ask questions and seek a second opinion where appropriate.

Explain and counsel in the language / dialect understood by the patient. Patients’ relatives, community members, or even a hospital staff member who understands the language of the doctor and the patient may serve as an interpreter. In case services of a translator / interpreter have been taken, especially in case of international patients, the translator / interpreter must write his/her name, also sign the consent as witness and record specifically that he / she has explained in the language understood by the patient and only thereafter the patient has signed the consent. Take proof of identity and contact details of the translator / interpreter and also ensure that he/she is legally competent and not below 18 years of age.

Explain and counsel in simple non-medical terms. Brochures / informative booklets / videos / digital and mobile-based educational tools / patient portals providing information about the interventions / therapies could be provided to the patient (Advisable) (also refer to clause 1.21). These shall supplement, not replace, the personal counselling by the doctor. These may be appended to the written consent or referenced in it.

Explain and counsel the various aspects of the proposed treatment / intervention to the patient by handwritten notes / diagrams / figures / images / models / posters / videos of organs / systems / diseases in appropriate cases and only if the same are easily available. Append these with the consent form. Thereafter follow the protocol, as far as applicable, prescribed in Clause 3.13 (Advisable).

Disclose to the patient and duly record in the consent:
i. Medically approved name of the treatment / surgery / procedure.
ii. Nature, purpose (intended benefits), consequence and outcome of the treatment / surgery / procedure and the complaint / condition  / disease / complication / diagnosis (final / provisional / differential) for which the same is advised.
iii. Likely prognosis in accordance with the accepted medical practice.
iv. Risks involved - the most commonly occurring risks and not the rare ones(also refer to – ‘Chapter 4. Risk information').
v. Commonly occurring life-threatening and non-life-threatening complications / side-effects /consequences - - Even those that are rare but likely to affect vision, hearing, motor and brain functions, or may result in amputation, disability, paralysis, infertility, serious bleeding, or death (Advisable).
vi. Special care and its level, if any, that may be required post treatment / surgery / procedure.
vii. Available alternatives – The relative advantages and disadvantages of each of the available alternatives and the preferred one with reason/s.
viii. Consequences, especially adverse, of refusal by the patient.
ix. The fact that the surgeon may come across unexpected situations during the course of surgery and it may require additional / alternative / extension other than what has been consented, and that the patient consents for the same.
x.. The fact that any part / tissue / fluid / organ removed from the patient’s body during the intervention may be sent for cytological or histopathological examination.
xi. In certain aesthetic / non-therapeutic interventions, disclose / record specifically that the outcome may not be commensurate with the patient’s expectation due to anatomical / procedural limitations.
xii. Name of the principal surgeon / principal anaesthesiologist / consultant in-charge, where decided and known at the time consent is obtained.
xiii. The fact that the consent form has been explained to the patient in the language he/she understands Also record the name of the language in which the patient has been explained (Advisable).
xiv. If any photos have to be taken / videos have to be recorded during the intervention, along with the purpose. Separate consent shall be obtained for educational, publication, research, promotional, or social-media use.
xv. Proposed date of surgery and date of obtaining consent.
xvi. Roles / limitations / responsibilities when Artificial Intelligence, predictive analytics, clinical decision support systems, or other advanced technologies materially contribute to diagnosis, planning, or treatment.
xvii. Do not use abbreviations / short-forms, even if they are commonly used among doctors.

Give the patient sufficient time, depending on the situation, to decide whether to give consent after counselling, except in life-threatening emergency situations such as an emergency caesarean, evacuation of a clot in the brain, and need for mechanical ventilation. If the patient’s clinical condition or other circumstances change during this period of contemplation, initiate the process for taking fresh consent.

Video Consent:
i. Video-record the pre-consent counselling session, especially in high-risk cases (also refer to Clause 1.18), only if the requisite facilities are easily available.
ii. Video recording is not an alternative but an addition to the written informed consent of the patient.
iii. Ensure that the CCTV signage is present in the counselling room and the patient is specifically informed of video-recording. This fact must also be specifically recorded in the written consent.
iv. Video-recording of consent is legally compulsory only in transplant surgeries and clinical trials.
v. Preserve the video footage with the written consent form for the requisite period.
vi. Ensure that digital storage of the video files complies with data protection laws, protects patient's confidentiality, and is appropriately secured against tampering and loss of data.
vii. Comply with the Digital Personal Data Protection Act 2023.

Multi-stage treatment:
i. Take single and comprehensive consent explaining the different stages one after the other even if the different stages are contemplated to be performed on different dates.
ii. Enumerate each stage specifically and separately in the consent.
iii. Inform the patient that he/she may withdraw consent at any stage of treatment. Record this aspect specifically in the consent.
iv. The patient can withdraw consent at any stage of the treatment by giving it in writing. The risks associated with withdrawing consent midway must be clearly communicated to the patient and recorded in the form in which the patient signifies the withdrawal of consent (also known as ‘negative consent). If the patient changes his/her mind after withdrawing consent and seeks to continue the treatment, fresh consent must be taken.
v. After taking such consent, if the patients’ condition changes significantly and/or any deviation is contemplated in the subsequent stages from the consented course, a fresh consent must be taken.

High-risk Consent:
Inform the patient specifically, duly record the same in the medical records, and take an elaborate high-risk consent if:
i. Unusual requests are made by patient / attendants, abnormal / suspicious circumstances, and such other conditions.
ii. The treatment / recovery is expected to take a very long time.
iii. The rate of failure is high.
iv. The technique / procedure / drug / protocol is relatively new / complicated.
v. Relapse is common.
vi. Presence of any co-morbid condition that may interfere with the surgery / procedure / treatment.
vii. The patient is in a critical state, with unstable vitals, or is even otherwise at high risk.
viii. Advanced age with significant frailty.
ix. Severe malnutrition / immunocompromised status.
x. History of adverse reaction to anaesthesia / drugs.
xi. Removal of any organ / limb is a possibility.
xii. You are proceeding with a surgery / procedure / treatment in spite of abnormal parameters.
xiii. The commonly occurring complications / side-effects  of the proposed technique / intervention / drug / protocol are serious / life-threatening / higher than usual.
xiv. Refusal of recommended treatment / referral / blood transfusion.

Independent witness:
i. Take patient’s consent in the presence of minimum one independent witness in case of high-risk consent (also refer to Clause 1.18).
ii. The witness must be legally competent - adult, conscious, and oriented.
iii. Ideally, the witness should not be connected to / employed by / related to / have a direct financial interest in the doctor / hospital / patient. If this is not possible, a patient's relative who knows English or the language of the consent form may be a suitable witness, provided the patient does not object. A hospital staff member may serve as a witness as a last resort.
iv. The witness must write in his / her handwriting on the consent form that the patient has informed the witness that the patient was explained the content of the consent form in the language / dialect known and spoken by the patient; the patient has consented to the same; and thereafter the patient has put his / her signature / thumb impression on the consent form in front of the witness (Advisable).
v. The witness must then sign the consent form, write his/her name, relation to the patient, and contact details in BOLD letters, along with the date and time.
vi. A copy of identity proof of the witness, self-attested, must be taken for the purpose of traceability and preserved with the consent form.
vii. Translator / interpreter whose services have been used could be an independent witness for that particular patient (also refer to Clause 1.11).
viii. The witness should be easily traceable in future and should not have any reservations in coming to the court and/or giving statements / affidavits.

Record specifically in the consent form if a consultant / surgeon has agreed to manage the patient only for a specific period,  only to perform the surgery / procedure or is taking a planned leave during the immediate post-surgery period and that thereafter the patient will be managed by other / another designated / assistant doctor. This clause will not apply to public hospitals. In case of group practice, patients consent must be taken for the group and name of all the members of the group must be clearly recorded in the consent form.

Prepare and provide the patient with a brochure / informative booklet, preferably in the local language/s, describing the therapy, risks, prognosis, and advantages of the treatment / interventions, especially in case of rare / new / complicated / risky - treatments / surgeries / procedures. Provide the above beforehand, and give the patient reasonable time to consider and decide. Append a copy of the brochure / booklet bearing the patient’s / attendants acknowledgment of receipt to the consent form or take their acknowledgement of receipt on the consent form. A digital copy of the brochure / booklet can also be emailed to the patient in advance (Advisable).

Check specifically whether the patients signature on the consent form is in English or not. If the signature is not in English, follow the protocol, as far as applicable, prescribed in Clause 1.23.

Taking consent of a patient not conversant with English / illiterate / semiliterate:
i. Exercise greater caution.
ii. Give the requisite information in the language / dialect known to the patient.
iii. If the doctor cannot speak the dialect, the patient must be asked to bring someone who can understand, translate, and explain to the patient. If the patient expresses inability to bring anyone, a staff member, or someone known to the doctor can be involved; but only as a last resort. Record this fact in the consent specifically, as well as the name and contact details of the translator, and obtain the translator's signature (Advisable).
iv. Take thumb impression (left hand for males and right hand for females) or signature of the patient.
v. Take signature of an independent witness (also refer to Clause 1.19) (Advisable).
vi. Specifically record the fact that consent was taken after counselling in the patients language.
vii. Ensure that the patient does not write anything on the consent that cannot be understood by the doctor / hospital staff.

Take thumb impression (left hand for males and right hand for females – a long-standing customary practice and administrative convention) on the consent of a ‘literate’ patient who is unable to sign due to any reason. Record specifically the reason for taking thumb impression and also take suitable endorsement from the patients relatives / friends / attendants on the consent, if possible. Follow the protocol, as far as applicable, prescribed in Clause 1.23.

Therapeutic Privilege:
A doctor withholding information from the patient for therapeutic purpose:
i. Exercise this option very rarely, in the patient’s interest and only if disclosure would otherwise interfere with treatment, or adversely affect the condition / recovery of the patient.
ii. Explain the reasons for withholding any information from the patient to the patients attendants / relatives and take their written endorsement of having received this information.
iii. Take opinion of other doctors involved with the patient and if they agree with your decision of withholding information from the patient take their written endorsement (Advisable).
iv. Any such request made by patient’s attendants / relatives, especially spouses, children or parents must be given due importance but the final decision must always be taken by the doctor. Take their request in writing, take their proof of identity, and duly preserve both with the consent.
v. Information may be shared with the relatives / caregivers / authorised persons only to the extent necessary.
vi. Ensure that any departure from full disclosure is clinically justified, carefully documented, proportionate to the circumstances, and subject to periodic review

Procedures / treatment with purely cosmetic value (generally performed by dermatologists, cosmetologists, dentists, plastic surgeons, and so on), where acceptance of post-procedure / treatment results is usually highly subjective, perceptive, and sensitive - Take signature of witness/es (also refer to Clause 1.19) (Advisable). Attach pre-procedure photographs and document expectation setting in the consent.

No separate consent is required for procedures which are part of the surgery for which the patient has already consented. Ensure that this additional part of the surgery has been specifically explained to the patient and also recorded in the consent.

Printed consent forms in English can also have its printed translated version in the local language/s appended as a separate leaflet or printed on the reverse side (Advisable).

Printed consent forms must have adequate demarcated blank spaces for inserting the procedure / patient specific information. If any part of the information is documented in any other space other than the designated space or on a separate sheet, follow the protocol prescribed in Clause 3.13. (The order of the National Consumer Commission on printed consent form holding otherwise has been stayed by the Supreme Court. This protocol is therefore currently legally acceptable but is subject to the final orders of the Supreme Court.)

Consent forms can have suitable columns / spaces for the patient to indicate whether the patient has executed any 'Advance Medical Directive (AMD)' as stipulated with the law laid down by the Supreme Court. A copy of AMD should be appended with the consent form. (AMD means and includes instructions given by a person regarding withdrawing / refusing treatment in certain conditions and is now legally recognized as per the judgment delivered by the Supreme Court in the case of Common Cause v/s Union of India.)

Consent forms can have suitable columns / spaces for the patient to indicate the names of relatives / attendants whom the patient prefers to be consulted / informed, to participate in decision-making, and/or to give consent on behalf of the patient in case the patient becomes incapacitated / incompetent during the course of treatment. Patients can fill this column / space with full name, address, and telephone number of such relatives / friends and also indicate the order of preference amongst them (Advisable). This consent is not valid for withdrawing / refusing treatment but for other purposes and should not be confused with AMD in Clause 2.3.

Consent form printed in the local language or the language that can be understood by the patient must be filled in the same language (Advisable).

Consent form can be filled / written by a doctor / nurse / counsellor, but the treating doctor remains legally responsible for taking proper consent. (This clause is for filling of the consent form and should not be confused with signing of the same).

Fill the consent form in one sitting even though counselling the patient may take more than one sitting (Advisable).

Avoid changing the pen or the person who is filling the consent form midway. Maintain uniformity in filling the consent form (Advisable).

Make entries in the designated spaces only. Mention specifically that appendices have been annexed if the designated space is inadequate. Number the pages, if consent is of more than one page.

Fill the consent form completely. Do not leave any space blank in a printed consent form. Write 'Not Applicable' or 'NA' in spaces where nothing needs be written (Advisable).

Try to avoid alteration, addition, overwriting, or erasure while filling the consent form. In case any minor correction / change / modification has to be made, encircle the incorrect portion, cancel with a single stroke and make the correction beside that portion with counter signatures, rather than cancelling,erasing or putting white ink. Filling a fresh consent form would be a better option (Advisable).

Take the patient’s signature / initials on every page of the consent form (Advisable).

Doctor-in-charge of the patient / principal surgeon / principal anaesthesiologist must also sign their respective consent forms. This clause may not apply to public hospitals where any doctor from the medical team managing the patient can sign the consent form.

Record specifically the name of the doctor / nurse / counsellor who has obtained patient’s signature on the consent form (Advisable).

Record the date and time when consent was signed by the patient. If there was an inordinate delay from the patient in giving consent, the date and time when consent was originally sought should also be recorded.

In appropriate cases, the patient should be asked to write in his/her handwriting that “Before signing this Consent Form, I have been explained / counselled in my language, and all my doubts have been cleared” (Advisable).

Fill the consent form in legible handwriting or use a computer-printed copy. Avoid using abbreviations / acronyms.

Writing a new sentence on a printed consent form below the space designated for the patient's signature - Take patient's signature with date and time below this newly added sentence.

Additional page/document appended with a consent form:
i. Append all these papers after the printed consent form.
ii. Number them serially. The printed consent form must also be numbered.
iii. Take patient’s signature on each page.
iv. Preserve these additional papers with the consent form for the requisite period.

Explain and record the most commonly, early as well as late occurring risks in the consent form.

All material risks, especially those having higher probability of occurrence, must be specifically spelt out to the patient and duly listed in the consent. The exact percentage of the risk as stated / accepted by medical science need not be specifically mentioned in the consent.

Answer questions raised by patients about a specific risk and record the same in the consent. The questions and answers can be appended to the consent form in a separate sheet.

During pre-surgery / procedure / treatment counselling, disclose to the patient and duly record in the consent:
i.If the failure rate is higher, or relapse or recurrence is a known possibility.
ii.Risk involving dysfunction / loss / diminution of life, vision, hearing, mental function, function of limbs and organs or may result in amputation, paralysis or serious bleeding even though the risk may be rare (Advisable).
iii. Risks that may materially affect the patient's profession, occupation, livelihood, or ability to perform occupational duties, particularly when such consequences are foreseeable given the patient's specific vocational requirements (Advisable).

Avoid disclosing risks that are remote, purely theoretical, or exceptionally rare. Similarly, do not convey information in a way that unnecessarily alarms, frightens, overwhelms, or confuses the patient (Advisable).

Do not delay taking the requisite steps to manage the patient by waiting for consent in emergencies if doing so could be detrimental to the patient. Follow the patient’s directions given in Advance Medical Directives (AMD) even in emergencies, if the patient has disclosed them or the doctor is aware of them. Document in the medical record all circumstances necessitating the emergency intervention without prior consent; the rationale for the decision; and any relevant discussions with family members / attendants.

Take consent from the patient even in emergencies, if the patient is an adult, competent and oriented. Only when an emergency patient is unconscious / incompetent to give consent:
i. Proceed with lifesaving treatment / surgery by taking oral consent of the patient, if possible, and in appropriate cases even without consent.
ii. Take proxy consent if the relatives / attendants are present at that point in time, or even from another doctor / Medical Superintendent / Head of the hospital, only if possible, and without much effort.
iii. Duly inform the hospital authorities.
iv. Record specifically in the patients’ medical records and / or the consent form the life-threatening emergency as well as the reason/s for not obtaining consent, or for obtaining proxy consent. This exercise can even be done once the emergency has been addressed and is over.

Consent and Age:
i. Child patient below 12 years - Take consent of the parents / guardian only.
ii. Child patient between 12 to 18 years - Take consent of the patient as well as the parents / guardian.
iii. Adult patient above 18 years - Take consent of the patient only.

Proxy consent 'giver' for minor / incompetent / emergency patient:
i. The general guiding principle is that competent adults responsible for the care of incompetent patients can give proxy consent
ii. Spouse / blood relatives / any other relative, preferably a first-degree relative (not mandatory).
iii. Biological parents / guardian(both legal as well as de-facto) of the child.
iv. Even the teacher / warden who brings the child to the doctor / hospital but only in an emergency (loco parentis).
v. Consent of any one of the child’s parents is valid and binding, even if there is a disagreement between them, except in cases where the court has given legal custody to one of them. Consent may be given by a person not connected with or related to the patient, including police personnel who may have brought such a patient (e.g., in accident cases), if none of the aforementioned proxy consent givers are available.
vi. Medical Superintendent / Head of the hospital or such other responsible person in institutions / hospitals.
vii. Person/s expressly indicated by the patient to give consent in accordance with his / her Advance Medical Directive (AMD) as prescribed by the Supreme Court.
viii. ‘Proxy consent’ means and includes ‘surrogate consent’ for all purposes and intent.

Taking proxy consent:
i. Counsel / explain in the language understood by the proxy consent giver. Follow all other protocols of taking consent of the patient as far as possible.
ii. Verify and record specifically the name, address, telephone number and relationship with the patient of the person from whom proxy consent has been obtained. It is advisable and not mandatory to take a self-attested photocopy of the proof of identity (having photo, age and signature) of the person giving proxy consent for the purpose of traceability. Match the signatures on the consent with that on the proof of identity.
iii. Record specifically the basis for determining incompetence and for obtaining proxy consent in the consent.
iv. Further directions / consent during treatment may be sought from such a person while the patient remains legally incompetent to consent.

Patient's orientation seems doubtful - Follow the protocol for incompetent patients rather than considering the patient as a competent one (Advisable).

Incompetent Patient - Means and includes minors; a person with mental illness who lacks the mental capacity or suffers from significant cognitive impairment or decline that impairs their competence; unconscious or anesthetized with alteration of sensorium; under the influence of drugs, sedatives, alcohol or substances that cloud consciousness or judgment; in such pain and agony that the patient is not in a position to give consent or complete other formalities; and so on. A disoriented patient is  incompetent to give consent.

A patient in labour with severe pain can be competent to give consent. Assess on a case-by-case basis.
 

In case the patient becomes competent / conscious during the course of treatment / intervention, take patient's consent, if possible.

In case of elective / non-emergency interventions, if the proxy consent giver is not available, postpone the intervention till the consent is obtained.

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; or do not restrict the scope or duration of consent.

Take consent closer to the day of the surgery / procedure and during the same admission (Advisable).

Disclose to the patient during pre-surgery counselling and record it 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 starting the surgery / procedure. Record specifically all such alternatives.
iv. The surgery / procedure may require multiple stages / sessions / sittings or operating simultaneously on multiple locations on the body during the same anaesthesia.
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.
ix. The expected visual, functional, anatomical, or cosmetic outcome may differ significantly.

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

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 taking a fresh consent or just add a line below the already signed consent validating it on the current date by signing afresh (Advisable).

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.

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 surgeons.

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 (also refer to – Clause 8.3).

Take 'high-risk consent' (also refer to - Clause 1.17) in appropriate cases. Inform the patient / attendants accordingly and record the said fact specifically in the medical records also.

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

Record the names of the principal surgeon and the principal anaesthesiologist in both the consent for surgery and the consent for anaesthesia.

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

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 substitutes even in an emergency not anticipated by the surgeon.
iii. This clause will not apply to public hospitals / 'group practice' where the consent is deemed to be for the treating team.
iv. The substitute surgeon who agrees to provide post-surgery care should be named specifically and must also sign the consent form.

Principal / primary surgeon should 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.

In case of an accidental injury / mishap / complication during a surgery / procedure follow the protocol, as far as applicable, prescribed in Chapter 8. - 'Additional / Alternative / Extension during a planned surgery / procedure'.

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

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. The patient should be asked to mention the name and contact coordinates of the person/s whose consent should be taken in such eventualities (Advisable).

Record specifically the names of each of the anticipated and foreseeable additional / alternative / extension in the consent. Do not use generic phrases such as 'any other procedure deemed necessary'.

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). This protocol becomes mandatory if the patient has named a person to give consent in such a situation as stipulated in Clause 8.1.
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).
v. Inform the patient’s attendants of the additional / alternative / extension at the earliest.

Counsel the patient (beneficiary) before taking consent for any family planning procedure. It is advisable to counsel the spouse as well but only with the patient’s consent. Record the counselling details in the consent, including the date, duration, and the counsellor's name.

Make enquiries to determine whether the couple has one living child above the age of 1 year, in accordance with the current national guidelines, and record this fact specifically in the consent. However, the decision to undergo the procedure remains the patient's exclusive choice, irrespective of past obstetric history.

Inform the patient and record specifically in the medical records:
i. The probability of failure of the procedure.
ii. The post-procedure precautions of abstinence for a specific period of six weeks, during which use of contraceptive like use of condoms, etc. is recommended.
iii. Missing / irregular periods after post-procedure needs to be taken as sign of pregnancy, the same can be confirmed by a pregnancy test and that government hospitals offer to perform Medical Termination of Pregnancy (MTP) free of charge.
iv. Record the aforementioned specifically in the consent.

Take consent of both the husband and wife for interventions that may result in sterility.

Interventions that may result in sterility in an unmarried patient / live-in couples:
i. Take a simple declaration about the patients’ marital status along with the consent.
ii. Carefully preserve this declaration with the consent.
iii. No consent of the other partner isrequired in such cases and only the patients’ consent will suffice.

Take only the patient's (woman) consent for MTP in Form C appended to MTP rules. Even administering MTP pill requires consent.In case of minors, take parents / guardian's signature on Form C.

Take separate and specific consent for transfusion of blood / blood products in all cases where transfusion is foreseeable and anticipated during an intervention.

In emergencies and when a blood / blood products transfusion could not have been foreseen, transfusion without consent is permissible. Document the emergency and the reasons for transfusion without consent in the medical record.

Take consent for blood / blood products transfusion for all surgeries / procedures along with consent for surgery / procedure (Advisable).

Counsel the patient that even though transfused blood / blood products are tested for HIV, HCV, Hep B and other microbial contamination / transmission according to the current guidelines, there remains a minimal but potential risk of these diseases being transmitted to the recipient as they cannot always be detected by tests done in blood banks (Advisable). Counsel about non-infectious risks as well.

Consent for multiple transfusion of blood / blood products once given by the patient remains valid for multiple transfusions in the same sitting or multiple sittings spread over a specified period.

Patients who are transfusion dependent (haemophilia, thalassaemia, etc.) or require long-term procedures (such as dialysis) - Consent for transfusion of blood / blood product/s once given by the patient to a doctor / hospital remains valid until the patient specifically withdraws it. Take fresh consent periodically, particularly when there is a material change in the clinical condition, indication for transfusion, anticipated risks, or treatment plan, or when the previously consented treatment episode has concluded.

Record specifically in both the consent and the medical records, if there is any delay / failure / hesitation / unwillingness / refusal / dissent on the part of the patient / attendants / relatives or conflict amongst attendants / relatives to give consent and the reason/s for the same. Explain / record the implications of this delay / refusal. 
 

Follow the protocol, as far as applicable, prescribed in Chapter 14. - Patient giving part consent and part refusal.

Record specifically the date and time when consent was sought and when the patient / attendants / relatives gave or refused to give consent in both the medical records and consent.

The doctor can withdraw from the patient / transfer the patient, in a non-emergency situation, if consent is refused or unusually delayed.

Contemplate whether the consented part can be disconnected from what has been refused.

Weigh the consequences of part consent - The doctor may even choose to withdraw from the patient in appropriate cases and non-emergency situation.

In case one proceeds with part consent - clearly record that the patient has given only part consent in the consent form; get the consent form attested by minimum one independent witness (also refer to Clause 1.19); and also record this fact in the patient’s medical records.

Take elaborate consent recording both - the best option and the alternative medically acceptable option chosen by the patient. Record the reason/s given by patients, even if it happens to be financial constraints (Advisable).

Explain to the patient and specifically record the relative advantages and disadvantages of both the options.

No consent is required for the clinical examination of a living person brought by the police, any other law-enforcing agency, or even for a walk-in patient such as survivors of road accidents, suicide, homicide, and so on, except for survivors of sexual abuse (also refer to Clause 16.2). However, a request by the police for a clinical examination must be entertained if made by “any police officer” as laid down in Section 51 (1) of The Bharatiya Nagarik Suraksha Sanhita, 2023. This clause applies solely to examinations for medicolegal purposes, not to the treatment of injuries or medical conditions, for which specific informed consent may be required.

Take specific written consent from a survivor of sexual abuse for clinical examination (per vaginal / per rectum / any other intimate) and / or for collection of sample / evidence, even if brought by the police. If the survivor is incompetent, follow the protocol, as far as applicable, prescribed in ‘Chapter 6. Minors / Incompetent / Emergency patients – Proxy Consent'. Do not mention the name or disclose the survivor’s identity in consent / medical records.

Record basic / essential details like the name, designation, ID number, police station of the police officer who has brought the survivor / patient; name, gender and age of the patient; date and time of examination; the purpose of examination; the procedure; and so on, on the consent form. Take suitable endorsement from the police officer on the same. Do not mention in consent / medical records the name of a sexual assault survivor or disclose their identity in any way.

Consent for treatment / surgery / procedure is required even in these cases.

Consent of prisoners (under-trials and convicts)/ persons under arrest or police custody is required like any other ordinary person for any treatment / surgery / procedure. In case of an 'incompetent' (also refer to – Chapter 6) prisoner, the Medical Superintendent of the hospital or the jail officials can give proxy consent.

Post mortem in case of suspicious / unnatural death where the cause of death is not evident / known to the doctor or death in medico legal case (MLC) - No consent of the patient’s relatives / friends / attendants is required for referring the dead body to police for post-mortem.

Pathological autopsies / Post Mortem in case of natural death (usually for academic and research purposes) - Consent of nearest relatives must be taken. Such consent can be withdrawn at any stage but before the start of the procedure.

Obtain specific written consent from the patient after providing the mandatory pre-test counselling for HIV testing. Ensure that consent for HIV testing is separate and distinct from other consents.

In situations / indications / cases where statutory / regulatory provisions (the written law) regarding consent are in force and are contrary to or inconsistent with this SOP, the former will prevail and must be followed. Similarly, take consent only in the format / sample consent form, if any, prescribed by the statutes / regulatory authorities. Currently in India, there are statutory / regulatory provisions relating to consent in organ and tissue transplantation, clinical research and clinical trials, investigation for HIV / AIDS, mental illness, Assisted Reproductive Technology (ART – IVF & Surrogacy), and telemedicine.