Healthcare providers need to pay greater attention to informed consent

Inadequacies in informed consent process in Indian healthcare system and importance of patient empowerment and understanding in treatment decisions.

In April, I visited a successful private hospital in Guwahati so my father-in-law could be treated for a collection of fluid around his left lung – known as a pleural effusion. To diagnose the cause, doctors suggested that some of the fluid be removed via a needle for testing, which is standard practice.

In the procedure room a nurse placed an unfilled consent form before me and said “Sign here.” This was the ‘Informed Consent’ form. Informed consent is considered the cornerstone of a doctor-patient relationship. It means that a patient needs to be given all the information regarding their condition, including treatment options, the steps of a procedure if one is suggested along with possible complications. This information allows the patient to make a balanced, well-informed decision on available options, including whether they would like to undergo the procedure (or consent to a treatment option or procedure, so to speak).

This blank consent form which was presented to me did not serve its intended purpose. It flouted the principles of informed consent as laid down by a seminal judgement of the Supreme Court in 2008, in several ways. Firstly, consent is supposed to be taken by the doctor performing the procedure, however, in most places in India, this work is relegated to the nurses to save the doctors’ time. The form also needs to contain information about the procedure and the possible complications in a language that the patient understands. Only after explaining the information clearly is the patient’s signature to be taken. However, in most hospitals across India, “Sign here” is often the only instruction patients receive before they are asked to consent to various treatments and medical procedures.

Over the years, several studies have been published auditing the informed consent process in various setups in India. These studies reveal gross inadequacies in the process of obtaining consent from patients. A study published in 2015 in the Journal of Obstetrics and Gynecology India revealed that while 75% per cent of women who underwent caesarean sections were told why they needed the surgery, only 25% were told the steps of the procedure and what complications could be expected. Another study, published in the Journal of Medical Society in 2019, audited 100 consent documents from different hospitals to check whether adequate information was provided in them. This study revealed that almost all the documents lacked around one-third of the essential medical information they needed to contain.

The other important aspect of health where consent plays a crucial role is biomedical research, where people may be enrolled as participants in clinical trials. There too, it appears that there are several issues with the robustness of the informed consent process. A 2023 study published in Perspectives in Clinical Research revealed that out of 44 online surveys audited, 10 completely lacked informed consent forms while the remaining 34 had informed consent forms which were either incomplete or not adherent to the guidelines set by ICMR (Indian Council of medical research)

“An informed consent form is a very important legal document,” says K. Mathiharan, a forensic medicine and medical law expert. “When a doctor faces litigation for medical negligence or for complications, the signed informed consent will prove that the patient was counselled regarding the complications and consented to the procedure with knowledge of the same. This is why doctors and hospitals prioritise getting signatures on these forms for every procedure,” he explains.

However, as evidenced by my own experience in the hospital, a signed consent form does not necessarily mean that any information was communicated.