1. ake consent only of the patient in a non-emergency situation if the patient is adult (also refer to Clause 6.1), competent (also refer to Clause 6.5), and oriented (in time, place, and person). Establish and confirm mental competence of all adult patients irrespective of the age. Do not consider older / elderly patients incompetent by default. In appropriate cases, especially high-risk cases (also refer to Clause 1.18), a confirmation from the next of kin, preferably a first-degree relative (not mandatory), may be taken or they may be asked to sign as a witness (also refer to Clause 1.19) (Advisable). In case next of kin is not available at that point in time, any relative, or even an unrelated friend / neighbour / attendant may be asked to sign as witness.
  2. 1.2Take ‘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 appropriate cases, signature of witness/es (also refer to Clause 1.19) may also be taken (Advisable).
  3. 1.3Do not take consent of spouse, children, or parents (instead of the patient)in case of an adult, competent 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, patients with cognitive defects and so on (Advisable).
  4. 1.4Take consent of both the spouses in case of a legally married patient undergoing Artificial Reproductive Technique (ART) Procedure. Record specifically the marital status of the patient.
  5. 1.5Take patient’s written consent rather than not taking one.
  6. 1.6Take written consent only for those investigations / diagnostics and therapeutic procedures, major or minor, IPD or OPD, that require invasive intervention and are not routine. Take written consent (advisable, not mandatory) for certain non-invasive therapeutic measures such as diathermy, lithotripsy, nuclear-scan ,CT scan using dye, BiPAP, chemotherapy, 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.
  7. 1.7No written consent is required for: 
    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, plain CT scan, and so on.
  8. 1.8Do 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. Provide information that is relevant to that particular patient, his/her general health status, social and financial situation, and which will help the patient to make an informed and independent choice.
  9. 1.9Do not deviate from what has been consented and agreed, except in life-threatening conditions, for bonafide reasons, and only in the patient’s interest (also refer to Chapter 8: Additional / Alternative / Extension during a planned surgery / procedure).
  10. 1.10Take 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.
  11. 1.11Explain and counsel in the language / dialect that can be understood by the patient. 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 proof of the translator / interpreter and also ensure that he/she is legally competent and not below 18 years of age.
  12. 1.12Explain and counsel in simple non-medical terms. Brochures / informative booklets about the interventions / therapies could be provided to the patient (Advisable) (also refer to clause 1.21).
  13. 1.13Explain and counsel the various aspects of the proposed treatment / intervention to the patient by handwritten notes / diagrams / figures / images / models / posters 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).
  14. 1.14Disclose 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 trouble /condition / disease / complication 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 complications /consequences that are rare but likely to affect vision, hearing, motor and brain functions, or may result in amputation, disability, paralysis, or serious bleeding (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 and principal anaesthetist. 
    xiii. The fact that the consent form has been explained to the patient in the language he/she understands.
  15. 1.15Give the patient reasonably enough time, depending on the situation, to take decision for giving consent after counselling except in emergency situations such as caesarean, evacuating clot setting on brain, need for mechanical ventilation, and so on. If the clinical condition of the patient changes during this period of patients’ contemplation, initiate the process for taking fresh consent.
  16. 1.16Video 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 this fact. (Advisable) 
    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.
  17. 1.17Multi-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. 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.
  18. 1.18High-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 / critical / 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 or is even otherwise at high risk. 
    viii. Removal of any organ / limb is a possibility. 
    ix. You are proceeding with a surgery / procedure / treatment in spite of abnormal parameters. 
    x. The patient has potential for creating trouble. 
    xi. The commonly occurring complications / side-effects of the proposed technique / intervention / drug / protocol are serious / life-threatening.
  19. 1.19Independent 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. Ideally the witness should not be connected / employed / related to the doctor, hospital, or patient. A patients relative knowing English or the language of the consent form could be a good choice as an independent witness. 
    iii. 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. 
    iv. The witness must then sign the consent form, write his / her name, relation with the patient, and contact coordinates in BOLD letters. A copy of identity proof of such a witness must be taken for the purpose of traceability and preserved with the consent form. 
    v. Translator / interpreter whose services have been used could be an independent witness for that particular patient (also refer to Clause 1.11). 
    vi. The witness should be easily traceable in future and should not have any reservations in coming to the court and/or giving statements / affidavits.
  20. 1.20Record specifically in the consent form if a consultant / surgeon has agreed to manage the patient only for a specific period or only to perform a surgery / procedure and that thereafter the patient will be managed by other / another designated / assistant doctor. This clause will not apply to public hospitals / group practice. 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.
  21. 1.21Prepare 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. The aforesaid should be provided beforehand and the patient must be given a reasonable time to contemplate to take a decision. Append a copy of such brochure / booklet bearing patient / attendants acknowledgment of receipt with the consent form.
  22. 1.22Check 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.
  23. 1.23Taking 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 (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.
  24. 1.24Take thumb impression (left hand for males and right hand for females) 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.
  25. 1.25Therapeutic 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, adversely affect the condition / recovery of the patient, or in case of certain diseases that are considered taboo. 
    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.
  26. 1.26Procedures / treatment with pure cosmetic values (generally performed by dermatologists, cosmetologists, dentists, plastic surgeons, and so on) where usually the acceptance of post-procedure / treatment results is highly subjective, perceptive, and sensitive – Take additional consent of the patients’ spouse / parents / relatives / friends but only after taking specific consent of the patient for the same (Advisable).
  27. 1.27No separate consent is required for procedures which are part of the surgery for which the patient has consented. Ensure that this additional part of the surgery has been specifically explained to the patient and also recorded in the consent.

2Consent Form 

3Filling the Consent Form

4Risk Information 


6Minor / Incompetent / Emergency patient – Proxy Consent

7Surgery / Procedure / Intervention

8Additional / Alternative / Extension During a Planned Surgery / Procedure (same anesthesia period)

9Family Planning Procedures

10Sterility Anticipated in an Intervention

11Medical Termination of Pregnancy

12Blood / Blood Products Transfusion

13Delay / Refusal to Consent

14Patient Giving Part Consent or Part Refusal

15Patients Refusal of the First / Best Option and Choice of Another Medically Acceptable Option

16Clinical Examination of Living Person for Medicolegal Purpose

17Consent for Post Mortem

18Consent for HIV Test

19Applicability / Exclusion

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