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

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

This blog deals with ideal consent form and the the manner in which the consent form has to be filled-

Consent Form

1. 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)

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2. Printed consent forms must have enough blank spaces for filling complete and additional 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 below (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.)

3. 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.)

4. Consent forms can have suitable columns / spaces for the patient to indicate the names of relatives / attendants who should be consulted / informed, will take decisions, and/or 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.

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Filling the Consent Form

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

02. Consent form can be filled / written by a doctor / nurse / counsellor. (This clause is for filling of the consent form and should not be confused with signing of the same).

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

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

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05. 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.

06. 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)

07.  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 beside that portion with counter signatures, rather than erasing or putting white ink. Filling a fresh consent form would be a better option (Advisable).

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

09.  Doctor-in-charge of the patient / principal surgeon / principal anaesthetist must also sign the consent form.

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

11.  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.

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12.  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)

13.  Fill the consent form in legible handwriting. Avoid using abbreviations / acronyms.

14.  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.

15.  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.