Consent Forms in Medical Procedures in India - A recent NCDRC Judgement determines a standard pre-printed consent form with handwritten text as unfair trade practice. How common is this practice ? Participate in our Survey on same !
Consent Forms in Medical Procedures in India

‘Consent’ is a very well-known  concept found in pretty much every aspect of law.

Every transaction to be legal requires consent amongst entities capable of giving so. Else the transaction is, generally, void or voidable at the peril of one party or another.

Accordingly, consent finds center place in Contracts Act, Hindu Marriage Act , and several provisions of the Indian Penal Code , to name just some examples.

Consent in Medical situations, however, is a more complicated matter. To begin with the two parties are unequally placed. On one side is a patient, in need of succor and help , and not aware of what is wrong with him or her. On the other side is a Doctor, an expert in his/ her field, and capable of giving the succor that the patient desperately needs.

With this background, the patient is supposed to be explained the treatment recommended and its risks and benefits. This is an ‘Informed Consent ‘and is (supposed to be) taken from a patient prior to any procedure that may have one or more risks to the patient. 

There is a plethora of case laws on the subject of ‘Informed Consent’ that has evolved over the years, addressing essentially what is proper and valid consent. Indeed a Consent form is a very oft cited aspect in a medical negligence case and many defects have been found in same, to the extent of consent form being forged !

Still, the process has lacunae. That may sometimes be harmful to the patients, and to doctors/hospitals as well ( as in the case cited hereunder ).

Sometimes, the judicial system intervenes to try to remove those lacunae.One such intervention is a recent judgement by the Honorable National Consumer Disputes Redressed Commission ( NCDRC) . In the case of Vinod Khanna vs  R. G. Stone Urology Hospital and Ors ( Consumer Case No. 428 of 2018 ), the Hon’ble NCDRC has ruled that :

“ The use of pre-printed and fixed “informed consent cum undertaking” forms by the hospitals to record consent from the patients amounts to “unfair trade practice” within the meaning of Section 2(1)(r) of the Consumer Protection Act, 1986.”

Hon’ble NCDRC observes in the Judgement  ( Para 4) :

“However, we cannot ignore the peculiarity of the ‘informed consent’ in the instant case which needs prompt and proper rectification. It is pertinent to note that it is a pre-printed form- ‘informed consent cum undertaking’ having blank spaces for limited selective handwritten entries and for the signatures. The main body of the form is fixed pre-printed. Such consent form fits into any procedure, any doctor, and any patient. Thus, it will take shape of informed consent if someone after filling up the blank spaces in handwriting and affixing the signatures of the patient and his sister as witness. This to be administrative arbitrariness and one-sided high handedness, and to be unfair and deceptive, on the part of the OP-1 (hospital); though the complainant has not been prejudiced in this particular case”.

Emphasis is mine.

And at para 7 :

With reference to our observations (supra) on the ‘informed consent’ (para 4), we but determine the uniform use of this pre-printed and fixed ‘informed consent cum undertaking’ form on the part of the OP-1 (hospital) to be unfair trade practice within the meaning of section 2(1)(r) of the Act 1986 and deem it just and appropriate to impose a cost of Rs. 10 lakh on the OP-1 (hospital), to be deposited with the Consumer Legal Aid Account of this Commission within four weeks of the pronouncement of the reasoned judgement, and to direct the OP-1 (hospital) to discontinue its said unfair trade practice with immediate effect.

Elaboration follows at Para 9(d) :

We but note that a pre-printed and fixed ‘informed consent cum undertaking’ form, with blank spaces for limited select handwritten entries and for the signatures has been used. The main body of the form is pre- printed and fixed. It can fit into any procedure, any doctor, and any patient, after filling up the blank spaces for the limited select handwritten entries and getting / affixing the signatures. We note this to be administrative arbitrariness and one-sided high handedness, and to be unfair and deceptive, on the part of the opposite party no. 1 (hospital), for which, though, the complainant has not been prejudiced in this particular case.

What is interesting to note is that the Hon’ble NCRDC found ‘pre-printed consent form with blank spaces for handwritten entries’ to be unfair trade practice  in this instant case. While no medical negligence per se was found, this conduct invited a cost of Rs. 10 lacs upon the concerned Hospital by the Hon’ble NCDRC.  

While there is no clear data available, what is observed from many medical negligence cases, as well as from actual experience, is that usage of such forms is quite common across India !

I could be wrong, however. So, I thought of conducting a Survey to find what the ground reality has been so far.

Please click here to participate in this survey.

Or you may participate from here itself as under.

Summary Results will be periodically published on this page. Those who participate in the Survey and provide their e-mail id therein will be sent a more detailed report on its completion.

Here a snippet of response to the first question as of 24th July 10 PM (IST) . I am not indicating more to minimize/avoid any bias. This is just to indicate how the summary results will look, and to request all to participate. As we all know, a large sample size leads to more reliable results.

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