SOP on Patients Consent 2016
1 Consent in non-emergency situations – General Procedures
1.1 Take 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 appropriate cases, especially high risk (also refer to - Clause 1.17), additional consent from the next of kin may be taken.(Advisable)
1.2 Take ‘proxy’ consent from competent adults responsible for incompetent patients. (also refer to – ‘Chapter 6. Minors / Incompetent / Emergency patients – Proxy Consent)’. In appropriate cases, signature of witness/es may also be taken.(Advisable)
1.3 Do not take consent of spouse, children or parents in case of an adult, competent and oriented patient. However, they may be asked to sign as witnesses, especially in high risk cases. (Advisable)
1.4 Take patient's written consent rather than not taking one. (Advisable)
1.5 Take written consent only for those investigations / diagnostic and therapeutic procedures that require invasive intervention. Take written consent (advisable not mandatory) for certain non-invasive therapeutic measures such as diathermy, lithotripsy, nuclear scan, and so on. (Advisable)
1.6 No written consent is required:
i.    For routine investigations such as drawing of blood.
ii.    From OPD patients on routine visits.
iii.    For non-invasive diagnostic / therapeutic procedures such as ECG, plain CT scan, and so on.

1.7 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 giving relevant information about the proposed treatment / intervention and discussing with the patient, arriving at a mutual agreement and then filling and signing the consent.
1.8 Do 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').
1.9 Take consent only after complete disclosures and proper explanation, neither by unduly scaring nor falsely alluring the patient into acceptance.
1.10 Explain and counsel in the language / dialect understood by the patient. In case services of a translator / interpreter have been taken, especially in case of international patients, the translator / interpreter must 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.
1.11 Explain and counsel in simple non-medical terms.
1.12 Explain 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 and only if the same are easily available. Annex these with the consent. Thereafter follow the protocol, as far as applicable, prescribed in Clause 3.13. (Advisable)
1.13 Disclose to the patient and duly record in the consent:
i.    Medically approved name of the treatment / surgery / procedure
ii.    Nature and purpose (intended benefits) of the treatment / surgery / procedure and the trouble / disease / complication for which the same is advised
iii.    Likely prognosis
iv.    Risks involved (also refer to – ‘Chapter 4. Risk information)’
v.    Commonly occurring life threatening and non life threatening complications / consequences - Even complications / consequences that are rare but likely to affect vision, hearing, motor and brain functions, or may result in amputation, paralysis or serious bleeding (Advisable)
vi.    Available alternatives – The relative advantages and disadvantages of each of the available alternatives and the preferred one with reason/s.
vii.    Adverse consequences of refusal by the patient.
viii.    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.

1.14 Give the patient reasonably enough time, depending on the situation, to take decision for giving consent after counseling except in emergency situations such as caeserean, 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.
1.15 Video-record the pre-consent counselling session, especially in high risk cases (also refer to - Clause 1.17), only if the requisite facilities are easily available. Ensure that the CCTV signage is present in the counselling room and the patient is specifically informed of this fact. (Advisable)
1.16 Multi-stage treatment - 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. Enumerate each stage specifically and separately in the consent.
1.17 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 / 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 inspite of abnormal parameters.
x. The patient has potential for creating trouble.

1.18 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 1.17).
ii.    Ideally the witness should not be connected / employed / related to the doctor, hospital or patient. A patients relative knowing English 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 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. The witness must then sign the consent form, write his / her name, relation with the patient and contact co-ordinates. A copy of identity proof of such a witness must be taken for the purpose of traceability and preserved with the consent form.
iv.    Translator / interpreter whose services have been used could be an independent witness for that particular patient (also refer to - Clause 1.10).

1.19 Record 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'.
1.20 Prepare and provide the patients with a brochure, preferably in the local language/s, describing the therapy, risks, prognosis, and advantages of the commonly performed treatment / interventions especially in case of rare / new / complicated / risky - treatments / surgeries / procedures. Take acknowledgment of receipt from the patient and duly preserve this acknowledgment with the consent. (Advisable)
1.21 Check specifically whether the patient's 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 1.22.
1.22 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, staff members 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 1.18.). (Advisable)
vi.    Specifically record the fact that consent was taken after counseling in the patient’s language.
vii.    Ensure that the patient does not write anything on the consent that cannot be understood by the doctor / hospital staff.

1.23 Take 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 patient's relatives / friends / attendants on the consent, if possible. Follow the protocol, as far as applicable, prescribed in Clause 1.22.
1.24 Therapeutic Privilege: A doctor withholding information from the patient for therapeutic purpose
i. Exercise this option very rarely, in the patients 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 patients 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 and duly preserve it with the consent.

1.25 Procedures / treatment with pure cosmetic values (generally performed by dermatologists, cosmetologists, dentists, 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)
2 Consent Form
2.1 Printed consent forms in English can also have its printed translated version in the local language appended as a separate leaflet or printed on the reverse side. (Advisable)
2.2 Printed consent forms must have enough blank spaces for filling complete and additional information.
2.3 Consent forms can have suitable columns / spaces for the patient to indicate the names of relatives / attendants whose directions should be followed in case the patient is not in a position to give further directions. Patients can fill this column / space with full name, address and telephone numbers of such relatives / friends and also indicate the order of preference amongst them. (Advisable)
3 Filling the Consent Form
3.1 Consent form can be filled in the local language or the language understood by the patient. (Advisable)
3.2 Consent form can be filled by a doctor / nurse.
3.3 Fill the consent form in one sitting even though counseling the patient may take more than one sitting. (Advisable)
3.4 Avoid changing the pen or the person who is filling the consent form midway. Maintain uniformity in filling the consent form. (Advisable)
3.5 Make entries in the designated spaces only. Mention specifically that appendices have been annexed if the designated space is inadequate
3.6 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 has to be written. (Advisable)
3.7 Try to avoid alteration, addition, overwriting or erasure while filling the consent form. In case any change has to be made, encircle the wrong portion, cancel with a single stroke and write the correct entry besides it with counter signatures rather than erasing or putting white ink. Filling a fresh leaflet of consent form would be a better option. (Advisable)
3.8 Take the patient’s signature / initials on every page of the consent form. (Advisable)
3.9 Doctor-in-charge of the patient / principal surgeon / principal anesthetist should also sign the consent form. 
3.10 Record specifically the name of the doctor / nurse who has obtained patient’s signature on the consent form. (Advisable)
3.11 Fill the consent form in legible handwriting. Avoid using abbreviations.
3.12 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.
3.13 Additional page/document attached with a consent form:
i.  Annex all these papers after the printed consent form.
ii. Number them serially. The printed consent form must be numbered one.
iii. Take patient’s signature on each page.

4 Risk Information
4.1 Explain and record the most commonly occurring risks in the consent.
4.2 All risks having probability of 10% or more must be specifically spelt out to the patient and duly enlisted in the consent. The exact percentage of the risk as stated / accepted by medical science need not be specifically mentioned in the consent.
4.3 Answer questions raised by patients about a specific risk and record the same in the consent.
4.4 During pre-surgery / procedure / treatment counseling, 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 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)

5 Emergencies
5.1 Do not wait for consent in emergencies if waiting could be detrimental to the patient.
5.2 Emergency patient incompetent to give consent; unaccompanied / unconscious patient; or patient brought by unrelated person/s:
i. Proceed with lifesaving treatment / surgery by taking oral consent of the patient 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 patient's 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 is over.

6 Minor / Incompetent / Emergency patient – Proxy Consent
6.1 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.

6.2 Proxy consent 'giver' for minor / incompetent / emergency patient
i. Spouse / blood relatives / any other relative.
ii. Biological parents / guardian.
iii. Even the teacher / warden who brings the child to the doctor / hospital but only in an emergency.
iv. Consent of any one of the parent is valid and binding even if there may be difference between both the parents.
v. Person not connected or related with the patient but who may have brought such a patient (eg. in accident cases).
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 when the patient was competent.

6.3 Taking proxy consent
i. 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.
ii. Record specifically the reason/s for obtaining proxy consent in the consent.
iii. Further directions / consent during the treatment may be sought from such a person.

6.4 Take additional consent of an attendant, preferably the closest relative present, if the patient's orientation seems doubtful.
6.5 Incompetent Patient - Means and includes minors; mentally unfit (lacks mental capacity); unconscious or anesthetized with alteration of sensorium;under the influence of drugs, 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 an incompetent patient.
7 Surgery / Procedure / Intervention
7.1 Do not take 'blanket' consent, general in nature, at the time of admitting a patient for surgery / procedure.
7.2 Try to take consent closer to the day of the surgery / procedure. (Advisable)
7.3 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 opening the patient - 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 for that particular surgery / procedure / disease.

7.4 Record the date fixed for performing a scheduled, non-emergency elective surgery / procedure in the consent.
7.5 No fresh consent is required if the surgery / procedure is rescheduled but without any change to whatever was originally consented by the patient.
7.6 Take composite consent for both the surgery / procedure and re-exploration, if foreseeable and anticipated.
7.7 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.
7.8 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).
7.9 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.
7.10 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.

7.11 Record specifically name of the principal surgeon and the principal anesthetist in the consent.
7.12 Take a fresh consent if the doctor scheduled to perform a surgery / procedure for whom the patient had specifically consented is changed.
7.13 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.

7.14 Confirm before starting every surgery / procedure whether the OT nurse has personally checked the consent form/s in the patient's medical records, it is signed by the patient and complete in all respect.
7.15 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'.
7.16 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 for research purpose requires separate specific consent as per ICMR guidelines.
8 Additional / Alternative / Extension During a Planned Surgery / Procedure (same anesthesia period)
8.1 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.
8.2 Record specifically the name/s of each of the anticipated and foreseeable additional / alternative / extension in the consent.
8.3 Additional / alternative / extension during the course of a surgery / procedure without the patient’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 patients attendants.

9 Family Planning Procedures
9.1 Counsel the patient before taking consent for any family planning procedure. It is advisable to counsel the spouse also but with the patient's consent.
9.2 Make enquiries whether the couple has one living child above the age of 5 years. (Advisable) However the decision to undergo the procedure is still the patient's exclusive choice irrespective of past obstetric history.
9.3 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 of period by female patient after post procedure needs to be taken as sign of pregnancy and that government hospitals offer to perform Medical Termination of Pregnancy (MTP) free of charge
iv. Record the aforementioned specifically in the consent.

10 Sterility Anticipated in an Intervention
10.1 Take consent of both the husband and wife for interventions that may result in sterility.
10.2 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 is required in such cases and only the patients consent will suffice.

11 Medical Termination of Pregnancy
11.1 Take only the patient's (woman) consent for MTP in Form C appended to MTP rules - Even administering MTP pill requires consent.
11.2 Counsel the patient intending to undergo MTP all alone at least once. Duly record this fact in the consent. (Advisable)
12 Blood / Blood Products Transfusion
12.1 Take separate and specific consent for blood / blood products transfusion in all cases where transfusion is foreseeable and anticipated.
12.2 In emergencies and in cases where blood / blood products transfusion could not have been foreseeable and anticipated, blood / blood products transfusion even without consent is permissible.
12.3 Take consent for blood / blood products transfusion for all surgeries / procedures along with consent for surgery / procedure. (Advisable)
12.4 Counsel the patient that even though transfused blood / blood products is tested for HIV, HCV, Hep B and other microbial contamination / transmission according to the current guidelines, yet there remains a minimal but potential probability of these diseases getting transmitted to the recipient as they cannot be always detected by tests done in blood banks. (Advisable)
12.5 Consent for 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 few days.
12.6 Patients who are transfusion dependant (hemophilia, thallassemia, etc.) or require to undergo procedure for a long time (dialysis) - Consent for transfusion of blood / blood products once given by the patient remains valid till the time it is specifically withdrawn by the patient.
13 Delay / Refusal to Consent
13.1 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 to give consent form.
13.2 Follow the protocol, as far as applicable, prescribed in Chapter 14. - Patient giving part consent and part refusal.
13.3 Record specifically the date and time when the patient's consent was sought and when the patient gave or refused to give consent in both the medical records and consent.
13.4 The doctor can withdraw from the patient / transfer the patient, in a non-emergency situation, if consent is refused or unusually delayed.
14 Patient Giving Part Consent or Part Refusal
14.1 Contemplate whether the consented part can be disconnected from what has been refused.
14.2 Weigh the consequences of part consent - The doctor may even choose to withdraw from the patient in appropriate cases and non-emergency situation.
14.3 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 1.18); and also record this fact in the patient’s medical records.
15 Patients Refusal of the First / Best Option and Choice of Another Medically Acceptable Option
15.1 Take elaborate consent recording both the best option and the option chosen by the patient.
15.2 Explain to the patient and specifically record the relative advantages and disadvantages of both the options.
16 Clinical Examination of Living Person for Medicolegal Purpose
16.1 No consent is required for clinical examination of a living person brought by the police, any other law-enforcing agency or even a walk-in patient like victim of road accident, suicide survivor, homicide survivor, and so on.
16.2 Take specific written consent of a victim of sexual abuse for clinical examination (per vaginal / per rectum) even if brought by the police. If the victim is incompetent, follow the protocol, as far as applicable, prescribed in ‘Chapter 6. Minors / Incompetent / Emergency patients – Proxy Consent'.
16.3 Record elementary details like the name, designation, police station of the police officer who has     brought the patient; name and age of the patient; date and time of examination; the purpose     of examination; the procedure; and so on.
16.4 Consent for treatment / surgery / procedure is required even in these cases.
16.5 Consent of prisoners / 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 – Clause 1.18) prisoner, the Medical Superintendent of the hospital or the jail officials can give proxy consent.
17 Consent for Post Mortem
17.1 Post mortem in case of suspicious / unnatural death where the cause of death is not known to the doctor - No consent of the patient’s relatives / friends / attendants is required for referring the dead body to police for post-mortem.
17.2 Post Mortem in case of natural death (usually for academic and research purpose) - Consent of nearest relatives must be taken
18 Consent for HIV Test
18.1 Take written consent of the patient after proper counselling.