Aavishkaar, the annual intercollegiate festival of Seth GS Medical College and KEM Hospital, had a new event this year called OPIATE—Organised Platform for Interaction in Academic Themes and Events. The theme this year was ‘Ethical issues in modern medicine’. This article summarises the dicussion on informed consent.

The root cause of most medical lawsuits is the ill-understood nature of consent in medical practice. Informed consent is a ‘process’ of voluntary agreement, compliance or permission that is valid only if it is given after understanding what it is given for, and the ‘risks’ involved.

Since informed consent is a process, it must have a definite beginning and an endpoint. To be legally valid, it must be ‘informed’ and ‘intelligent’. The law requires that the patient be fully informed of every risk and relevant fact needed for giving a proper consent, and the consent itself be based upon such material disclosure.

For the consent to be intelligent, it is necessary that the patient understands what is explained. This would depend upon the intelligence of the patient, something that is difficult to judge. If one lacks clear guidelines, it is like being on an uncharted journey. There is no absolute way because the information involved is subjective and individual-specific. Thus, we start off on ambiguous grounds.

To make sure that the patient really understands the information, one conveys it in the patient’s own language, with the help of an interpreter, if required. What if the interpreter misguides the doctor, misinterprets the information unintentionally or out of vested interest?

‘How adequate is adequate?’ A little more information needs to be given to assess this. Thus, we add more information to the information which may already ill understood. To ensure that the patient has understood the material, he can be asked to explain the whole process. Thus, the doctor can clear any ambiguities, resulting in a better doctor-patient interaction.

‘What happens if the doctor himself is not sure of the step ahead?’ He must let his patient know this for better transparency. This will serve to cement the patient’s faith in the doctor. Furthermore, it will make the patient feel like ‘a part of the treatment’ rather than ‘a subject of the treatment’.

With regard to medical research, as the outcome of the process is not fully known, the very basis of the word ‘informed’ is lost and it is effectively a blanket consent. There is already staunch opposition to the concept of a blanket consent.

Another issue involved is that of motivated interests. While conducting a drug trial, the doctor has an interest in the trial results. This might make him compromise the patients’ interests. In addition, consider the emotional state of the patient. Is it rational on the part of the doctor to expect the patient (who is under physical and mental trauma) to understand what it is that he is giving his consent for? Patients tend to have more faith in the discretion of their doctors because they believe that the doctor can make the best decision for them as he is emotionally unbiased and more knowledgeable. Who will take the responsibility in the case of any medical mishap?

We conclude that ‘consent’ should not be common for all patients and needs to be individualised for every case. This is a difficult task. The sheer analysis that such an elaborate process demands would take a lot of time. It is impractical to expect a doctor to delve into such matters when even basic patient care is being compromised by time.

Informed consent needs a fresh approach. We require the process to undergo the ultimate test of its credibility—does it work in practice to satisfy all or most of the shortcomings? With patient education at an all-time high and better access to information on their health and disease, doctors need to brace up with information that will enable them to tackle their patients’ queries in entirety before consent is given and taken. For doctors working in a tertiary set-up, the challenges will continue to remain crude but nevertheless changes for the better are needed now more than before, as much as for the future.