The consent form a commission threw out
Every hospital I know has a consent form, printed in a pad, signed before every operation. The uncomfortable part is that the national commission has thrown such forms out. Not because nobody signed them. Because they were the same for every patient.
The standard, and it is older than you think
The case that still decides this is Samira Kohli v. Prabha Manchanda, from the Supreme Court in 2008. It is worth knowing what it actually asks for.
For consent to be real and valid, the patient has to be told six things: what the procedure is, why it is being done, what benefit is expected, what the risks are, what the other options are, and what happens if she says no. Take your own form and count how many of those six are on it in a way that fits this patient's operation.
The second part of the judgment is the one that catches careful, kind doctors. Except in an emergency, or when the patient is not able to decide, a relative's consent does not take the place of the patient's own. An adult who can decide, decides for herself, even when the whole family is standing there agreeing on her behalf.
Following that standard, the national commission has rejected printed consent forms that are the same for everyone. A consent that will hold up has to name the patient, the guardian if there is one, the doctor, the condition and the planned procedure. A printed paragraph with a signature at the bottom proves that a form was signed, and almost nothing else.
The rule, and the date
If you are anywhere near accreditation, this is no longer only a court question. The sixth edition of the NABH standards took effect on 1 January 2025, with ten chapters and 639 objective elements, and an explicit push toward digital health.
The patient rights chapter asks for consent that is written for that particular procedure, translated into a language the patient understands, witnessed, and with a copy given to the patient. Anaesthesia needs its own separate consent. And what you teach the patient and the family about the diagnosis, the medicines, the diet and the follow-up has to be written down for every admission, not assumed.
Informed consent sits in the core patient safety group. That is the set an assessor will not let you pass halfway.
What would have made the difference
- List the risks of this operation, not risks in general. If every form says only bleeding, infection and anaesthesia, it tells the court nothing. A hernia coming back after a repair, or a bile duct injury in a gall bladder operation, shows that this patient was really counselled.
- Take the patient's own signature whenever she can give it. Add the relative as a witness, not in her place. If the patient really cannot sign, write down why.
- Put it in the language you spoke. If you explained in Telugu or Kannada and the form is in English, the form is not a record of the conversation you actually had.
It is common, and it is the habit most likely to be pulled apart later. If the patient is an adult who can decide, her consent is the one that counts. A husband, a son or a brother signing in her place does not meet the test, unless she cannot give it herself or it is a real emergency.
The fix is not an argument with the family. It is one extra signature. Let the patient sign, let the relative sign as well, and note who else was present. Nobody in the room minds, and the whole argument disappears.
One thing this does not mean
This does not mean your printed forms are useless and should be thrown away. A witnessed, translated paper consent is still accepted, including by NABH. The point is smaller than that. The printed paragraph is the minimum. What makes it hold up is the part you write for this patient, in her language, with a time on it and the names of the people who were there.
Next month
Two dates every hospital should put in the diary, one in November 2026 and one in May 2027. And the NMC rule everyone panicked about, which is not in force at all.
Sources
- Samira Kohli v. Prabha Manchanda, Supreme Court of India, 2008. indiankanoon.org
- NCDRC on pre-printed consent forms and what a valid consent must name. lexology.com
- NABH 6th edition of the hospital accreditation standards, effective 1 January 2025. digitalhealthnews.com
Case Notes is written by Dr Ranadheer Raju C S, laparoscopic surgeon at Sri Sara Hospital, Tirupati. It is one doctor reading published judgments and standards, and writing them up for other doctors. It is not legal advice. If you have a case going on, talk to your own lawyer. If I have got something wrong, tell me and I will correct it here.
MedSaakshi makes consent and explanation records that are signed, timed, recorded and sealed. If that sounds useful, there is a demo at medsaakshi.com. If not, the note above is still yours to use.