Date: 4th July 2010
Author: Parag Vora
About: CEO, Infoseek India Private Limited (Patient Education Awareness Series)
Getting Informed consent from the patient remains a very tricky area in medical practice today . Failure to obtain valid consent is one the commonest reasons patients go to court when they are unhappy with their doctor.Unfortunately, no standardized guidelines have ever been published by the Medical Council of India, Indian Medical Association, or any other ‘reputed’ medical body. This is a huge lacuna, and the importance of taking consent has never been taught to most doctors properly, even though there has been a huge rise in medico-legal and malpractice claims in the past decade or so.
All over India there is a lot of diversity in the way consent is taken and interpreted. There have been instances where consents have been highly inadequate; and in some cases, the doctor has completely forgotten to take a consent altogether ! What makes a consent an ideal consent is still a grey area in India. The ambiguity in the consent document leads to variable interpretations that have resulted in damages to medical fraternity in the form of malpractice claims and litigations.
The Supreme Court of India has laid down certain guidelines in its various judgments for what makes a consent valid; and how it should be taken. Consent and its adequacy has been the most common issue that crops up in medico-legal situation. This is especially true in certain specialties such as obstetrics.
Initially, the concept of Informed consent was developed in order to protect the health of participants in clinical trials and healthcare research. However, in view of the importance of patient autonomy, and the need to protect doctors against medical lawsuits, it is now considered to be an important component of all aspects of health care. Though a very commonly used term, , the fact remains that it is very difficult to prove that the patient did in fact provide true “Informed consent” in a court of law in a medico-legal case.
There are many reasons for this. The limited amount of time available to counsel patients in a busy practice may make this impractical. Also, “How much to reveal” and “How to inform the patient about the risk of complications without scaring the patient away ” is another practical issue , thus making it difficult for doctors to fulfill the legal criterion of informed consent. The inadequate level of education and the language barrier poses another important and genuine problem in our country.
We all know that mere signing on the consent form is not considered to be enough in a court of in law. Similarly , doctors feel very vulnerable when a patient, inspite of being genuinely adequately informed about the risks of the procedure, conveniently claims that no explanation was given to him by the doctor, when he is on the witness stand !
All good doctors want to have a truthful, genuine, transparent doctor- patient relationship where the interests of both the parties are recognised and respected. There is adequate data to prove that giving proper information to patients has improved patient satisfaction and decreased litigation in medical practices.
As a step in streamlining the consent taking process and helping it to make it truly informed consent, to protect both doctors and patients , we are launching P.E.A.S™ Patient Consent software, which has been developed with the help of one of India’s leading medicolegal experts, Dr Nikhil Datar. This software helps manage medicolegal risk with innovative tools which enhance doctor-patient communication at the same time ! The software provides a multilingual, audio visual patient information – cum – consent taking solution for the first time in India . This allows doctors to achieve detailed, provable documentation of the consent process , without wasting his precious time .