Healthcare providers need to pay greater attention to informed consent

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.

Inadequate process

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.

Inability to consent

“Most of the forms you see in hospitals are in English. This means that they cannot be read by people who don’t know the language and they depend on doctors/nurses to tell them what’s in the form. Some patients may not know how to sign and one will see an interesting juxtaposition of their fingerprints on a paper with long flowing English paragraphs,” adds Dr. Matiharan.

“I have met patients carrying forms that state that they have left a hospital against medical advice,” says a duty doctor working in Satribari Christian Hospital, Guwahati. “When asked why they left the hospital, they say that they were told that the hospital had no beds and that they were being referred elsewhere and made to sign the paper. They did not know that the paper implied that they left against the advice of the doctor,” he said.

These narratives as well as statistics come together to impress upon us that the informed consent procedure in India leaves a lot to be desired. Before considering solutions, it is crucial to understand why it is important to obtain informed consent. Studies show that patients experience more satisfaction with their treatment if adequate information is provided and consent is taken. Studies also reveal that patients respond better to treatment when a good informed consent process is employed before initiating it. Informed consent also opens the door for shared decision-making – where a patient and the doctor work as a team to ensure the best possible outcome while keeping patient preferences in mind. Several studies reveal that this approach leads to better long-term outcomes for the patient.

“When done right, the informed consent process can protect doctors in more ways than one,” says Dr. Mathiharan. In India, a country where there is recorded distrust of doctors which has led to violence; rapport and trust must be built by providing detailed and timely information to patients and their relatives. “I prioritise explaining everything to my patients in detail,” says Pravin Singarayar, an obstetrician from Sittlingi, in Dharmapuri, Tamil Nadu, who serves a tribal population. “I always give them timely updates about what is happening to the patient and I ensure I do it in person. I think it’s because of this habit that I have never faced any threat of violence to date,” he adds.

Moral imperative

The informed consent process is a moral imperative – something that holds good even without statistics to justify its existence. Every person deserves to know exactly what is happening to their body and what might happen if they agree to a treatment or procedure. This becomes especially relevant in cases where the loss of life or organs is involved. An example would be severely-ill patients who may have signed a “Do not resuscitate” form either on their own or via their relatives. In these cases, consent taken with inadequate information can lead to an infringement on the patient’s right to life.

“I think the important first step is to create awareness among patients that they have a right to this information,” says Dr Mohammad Aslam Ali, a consultant dermatologist in Guwahati. “No one should sign any papers given to them in hospitals unless they have read and understood the contents well. I would suggest patients demand the consent form in their native language or ask family or friends to read it to foster good comprehension. Once patients start making these demands, it’s only a matter of time before doctors and hospitals course correct,” he adds.

“Some hospitals refuse to give patients their papers or printed copies of test reports. Patients must know that they have a right to their medical information and can demand it.”

It is also important for hospitals to carry these forms in local languages. Other steps to increase understanding of information could be the use of image or video-based tools to explain the procedure. Several studies demonstrate the success of video-based informed consent tools in helping patients decide what is best for them in a balanced manner. The usage of videos can also overcome literacy barriers and decrease patient anxiety about procedures.

Inadequate infrastructure

The issue with informed consent reflects a larger systemic issue of poor infrastructure and manpower which leads to doctors being unable to uphold the highest professional and ethical standards. However, by failing to do so, they are also subjecting themselves to decreased patient satisfaction and misunderstandings which could lead to violence and legal issues. This shows that there is an urgent need to initiate discourse and standardise practices of obtaining informed consent across institutions.

As for my story, I started filling up the informed consent form myself in front of the nurse. I wrote the name of the procedure and started listing out the complications before signing. Seeing this, the nurse immediately alerted the doctor who then came out to finally have the conversation. Eventually, I left the hospital with the realisation that only my privilege of being a healthcare professional led to my father-in-law receiving a fair informed consent process.

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