Free tool
Informed consent form format for clinics. English and Hindi, on your letterhead.
Free informed consent form for Indian clinics in English and Hindi: nature, purpose, risks, alternatives, refusal, guardian and witness lines. Prints A4.
Form
Leave any field empty to print a ruled line and write it by hand. The Hindi text has been written for this form; read it once before you use it.
Patient
What you explained
The Supreme Court in Samira Kohli lists what the patient must be told: the nature and purpose of the procedure, alternatives, the substantial risks and the consequences of refusing. Write each in plain words for this patient. Each box prints on about two lines; add anything longer by hand on the printed form.
Who explained and who signs
Clinic
Logo
Clinic logo only; a photograph of yourself on a letterhead is barred by clause 6.1.2. PNG or JPG, stays in this browser.
Doctor
Layout
The rules behind each line are in our post on informed consent in an OPD.
Add the doctor's name and registration number to print.
Everything you type is kept only in this browser on this device and is never sent to Vitels. It is not encrypted and anyone using this browser can see it, so press Clear after printing on a shared computer. In the print window choose “Save as PDF” for a file.
Clinic name
Dr. Name
Informed consent for a procedure / प्रक्रिया के लिए सूचित सहमति
Procedure, filled in by the doctor / प्रक्रिया, डॉक्टर द्वारा भरा जाए
What it is, in plain words / यह क्या है, सरल शब्दों में
Why it is advised / इसकी सलाह क्यों दी गई
Substantial risks / मुख्य जोखिम
Alternatives, including not now / विकल्प, अभी न कराना भी
If the patient refuses / मना करने पर क्या हो सकता है
Patient agrees to it / रोगी सहमत है
Does not agree / सहमत नहीं है
Not applicable / लागू नहीं
Patient's statement / रोगी का कथन
The doctor named below has explained to me, in a language I understand, what the procedure written above is and why it is advised, its substantial risks, the alternatives and what may happen if I refuse. I was able to ask questions and they were answered. I agree to this procedure.नीचे नामित डॉक्टर ने मुझे मेरी समझ की भाषा में बताया है कि ऊपर लिखी प्रक्रिया क्या है और इसकी सलाह क्यों दी गई है, इसके मुख्य जोखिम क्या हैं, क्या विकल्प हैं और मना करने पर क्या हो सकता है। मुझे प्रश्न पूछने का अवसर मिला और मेरे प्रश्नों के उत्तर दिए गए। मैं इस प्रक्रिया के लिए अपनी सहमति देता / देती हूँ।Only if the patient is under 18 or cannot consent / केवल तब, जब रोगी 18 वर्ष से कम आयु का हो या सहमति देने में असमर्थ हो
Consent for this procedure only; consent to use personal data for messages is taken separately. Follows Samira Kohli v. Prabha Manchanda (Supreme Court, 2008) and regulation 7.16, IMC Regulations 2002.यह सहमति केवल इसी प्रक्रिया के लिए है। संदेशों के लिए व्यक्तिगत जानकारी के उपयोग की सहमति अलग से ली जाती है।
Preview at reduced size. This form prints on A4 only.
What Indian law asks of a consent form
The Supreme Court's 2008 judgment in Samira Kohli v. Prabha Manchanda sets the test for consent to treatment, and regulation 7.16 of the 2002 conduct regulations asks for it in writing before an operation.
- Samira Kohli v. Prabha Manchanda, Supreme Court, 16 Jan 2008, para 32(i)
Consent before any treatment
A doctor has to seek and secure the patient's consent before commencing treatment, and the term includes surgery. The consent has to be real and valid: the patient has capacity, agrees voluntarily, and has adequate information about the nature of the procedure, so that the patient knows what is being consented to.
- Samira Kohli, para 32(ii)
Four things the patient must be told
The doctor should disclose the nature and procedure of the treatment and its purpose, benefits and effect; alternatives if any; an outline of the substantial risks; and adverse consequences of refusing treatment. Remote or theoretical risks that may frighten or confuse the patient need not be explained.
- Samira Kohli, para 32(iii) and (iv)
One consent, one procedure
Consent for a diagnostic procedure is not consent for therapeutic treatment, and consent for one procedure is not valid for another. A further procedure that may become necessary during the first can be covered, but it has to be contemplated and named. The form has a separate line and tick for it.
- IMC Regulations 2002, regulation 7.16
In writing before an operation
Before performing an operation the physician should obtain consent in writing from the patient, or from the parent or guardian in the case of a minor. In an operation which may result in sterility the consent of both husband and wife is needed. The form adds a spouse line when you tick that box.
- Samira Kohli, para 45
An adult signs for themselves
When the patient is a competent adult, there is no question of someone else consenting on their behalf. In Samira Kohli a mother's consent, taken outside the theatre while her adult daughter was briefly under anaesthesia, was held not to be valid consent. The guardian line is for minors and patients who cannot consent.
- Samira Kohli, para 14
Ordinary consultation needs no form
Consent can be implied: when a patient sits in the dental chair, consent is implied for examination, diagnosis and consultation. Except where consent can be clearly and obviously implied, there should be express consent. Use this form for procedures, not for every OPD visit.
What a complete procedure consent form carries
In the order they appear on the printed form, following Samira Kohli and regulation 7.16. Anything you leave empty prints as a ruled line to fill by hand.
Clinic letterhead with the doctor's name and registration number
Patient's name, age, sex and clinic ID, with the date and time
The procedure by name, and the site or side
What it is, in plain words for this patient
Why it is advised and what it is expected to do
The substantial risks, each written out
Alternatives, including not having it now
What may happen if the patient refuses
Any further procedure that may become necessary, named, with the patient's own tick
Anaesthesia, if any
The patient's statement, in English and Hindi, that it was explained and questions were answered
The language it was explained in, and the interpreter's name if someone translated
Signature or thumb impression of the patient, and a witness who is not the treating doctor
Parent or guardian with relationship, only for a minor or a patient who cannot consent; spouse too where the procedure may cause sterility
Your signature, with the date and time
Keep the signed form with the visit
Vitels does not have a consent form module or e-signature. It keeps each visit's consultation and prescription with the date, and the clinic admin can export every record as CSV, so a paper or scanned consent can be matched to the visit it belongs to.
Straight answers
Does every OPD patient need to sign a consent form?
No. In Samira Kohli the Supreme Court treated consent for examination, diagnosis and consultation as implied when the patient comes in for it. Express consent is needed wherever consent is not clearly and obviously implied, and regulation 7.16 asks for written consent before an operation. Use a signed form for procedures with real risk, and a note in the record for routine steps.
Should the consent form be in Hindi or the patient's language?
No national rule names a language for treatment consent. What the Supreme Court asks is that the patient knows what is being consented to, and a form the patient cannot read does not show that. This form prints English and Hindi together, records the language you explained in, and has a line for an interpreter. For another regional language, explain in that language and write it on the form.
Who signs the consent form for a minor?
Regulation 7.16 asks for the written consent of the parent or guardian before an operation on a minor. The age of majority in India is eighteen under section 3 of the Majority Act, 1875. The form has a parent or guardian line with the relationship and a reason line, which you use only when the patient cannot sign for themselves.
How many risks do I have to write on the form?
Samira Kohli asks for an outline of the substantial risks, not remote or theoretical ones that may frighten or confuse the patient. The standard is what a body of doctors skilled in that field would accept as normal and proper, not the stricter American reasonable-patient test. Write the risks you would discuss with a colleague, by name, for this patient.
Can one consent form cover everything done during the procedure?
Only what it names. Consent for a diagnostic procedure does not cover treatment, and consent for one procedure does not cover another. The Court refused to read a general phrase such as “such medical treatment as is considered necessary” as consent to remove organs. Write any further procedure on its own line and let the patient tick agree or not agree.
Does the tool store patient details?
Patient and procedure details stay in this browser session only, unencrypted, on this device; closing the tab or pressing Clear removes them. The letterhead is kept for next time and shared with the other Vitels tools. Nothing is sent to Vitels. Press Clear after printing on a shared computer.
This tool only lays out a form. It does not decide what to tell a patient or whether a procedure needs written consent. The doctor who performs the procedure explains it and is responsible for what the form states. The Hindi text was written for this form; have it read by someone fluent before relying on it. This page summarises Samira Kohli v. Prabha Manchanda (2008) 2 SCC 1 and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002; it is general information, not legal advice. Your state rules or specialty body may ask for more.
Related tools and pages
Informed consent in an OPD
The rules behind every line of this form: Samira Kohli, regulation 7.16, minors, language and DPDP data consent.
OpenPatient registration form
The front-desk form, with a DPDP notice and separate WhatsApp and SMS consent ticks.
OpenConsumer Protection Act and negligence
How a consent complaint reaches a consumer commission, and what a clinic is asked to show.
Open