This article has been written by Nehal Misra, from Nirma University, Ahmedabad. In this article, she discusses the insights related to informed consent in reference to the infamous Samira Kohli case.

Introduction

The intertwining nature of law and ethics is evident in both focus on human beings right and wrong behaviours. Though they intertwine, their ability to enforce ethical behaviour differs. The legal agreement thus is a statement of social consensus on ethics. One of the issues surrounding the doctor-patient relationship in medicine and law is “informed consent.” This topic, taken from clinical ethics, has been at the forefront of biomedical ethics since the Nuremberg trials and other instances of human experimentation. The proponents of “informed consent” mooted the idea in different ways – from shared decision-making to an individual’s autonomous authorization to undergo medical interventions or participate in research.

The development of informed consent is well known, in both tort law and common law jurisdictions, and is directly related to the self-determination of a person. Self-determination is essentially the right to non-interference where a person has the right to make decisions about one’s own life without other people’s intervention or interference. The informed consent doctrine can be traced to American law and emphasis has been placed on individual autonomy. It was first introduced as a legal doctrine in the case of Canterbury vs. Spence, in the US in 1971. This case involved a boy who was paralyzed following surgery with the back. The court argued against the knowledge disclosure requirement of the doctor and found the requirement of informed consent of the patient to be fair. Canterbury Court held that a patient’s circumstances should be taken into account in the standard of disclosure of information. Therefore, this case stressed the autonomy of the patient, which allows the practitioner to provide the patient with knowledge as a duty. While informed consent was initially acknowledged in the UK in Sidaway vs Board of Governors of Bethlem Royal Hospital and Maudsley Hospital and others, 1985, it was not acknowledged exactly in the sense it is being applied in the US. In this case, the operation performed by the surgeon left the patient paralyzed. The plaintiff alleged the surgeon was negligent in failing to disclose or explain the inherent risks of the operation. The judge applied the “Bolam test,” which was first developed in 1957’s Bolam vs. Friern Hospital Management Committee. Under the Bolam test, professional standards were set for professional conduct according to peer standards. This means that it is doctors who decide how much to tell patients about the therapy risks, and therefore a doctor can not be sued if he/she fails to inform the patient about the risks if other reasonable doctors had not informed the patient about them in the given situation.

In Samira Kohli vs. Prabha Manchanda Dr. & ANR 1(2008)CPJ 56 (SC) judgment, India’s Supreme Court has elaborated on different aspects of consent taking. It has also set out such requirements for a true or legitimate consent to be taken. As such, an effort is being made to streamline the consent procedure in India. The judgment was linked to a gynaecological case in which Hysterectomy was performed as further treatment. Although the initial consent for diagnostic laparoscopy was obtained, under general anaesthesia, hysterectomy and removal of both ovaries were performed in the same sitting. Hysterectomy consent was therefore obtained from the patient’s mother. The Supreme Court held the doctor liable for malpractice overruling the order passed by the National Commission for the Redress of Consumer Disputes. The Supreme Court held that however beneficial to the patient in saving time, expenses, pain, and suffering, additional surgery is no ground for defence. However, it also rendered the exception. This judgment took into account all aspects related to consent for India in reference to the aspects of consent in the United Kingdom, Australia, Canada, and the United States. The judgment further differentiated between Informed consent and real or valid consent. Moreover, different aspects of the treatment were elaborated, including poor patient, long waiting period, lack of infrastructure, and commercialization of medical practice. The Honorable Supreme Court expressed great concern about Indian patients’ confusion when it came to knowing what they should sign, and thus concluded the form of consent to be exercised in India. However, it presents new challenges to all of us, such as who will agree to it, what exactly is appropriate knowledge for the patient, what are additional procedures in surgical or neurochirurgica practice, and some other issues that should be resolved by joint efforts by Neurosurgeon practising anywhere in India.

Informed consent

Consent in the medical profession means the patient’s consent to perform an act on his body for treatment or therapeutic operation. It can be implied, expressed e.g. as a patient enters a clinic for their examination, sits for the same purpose on the dental chair. Many forms of consent are taught all over the world. The principle of informed consent prevails in the United States, while the United Kingdom applies to real or valid consent. The fundamental concept of patient consent is derived from Justice Cardozo’s argument in Schoendorff v. New York Hospital Society “every adult human being has the right to decide what should be done with his body and the surgeon who conducts the procedure without his patient consent commits an assault for which he is liable for the injury.” Informed consent is a process for obtaining permission or disclosure of personal information before performing a healthcare intervention on a person. A health care provider may ask a patient to agree to receive therapy before administering the therapy, or a clinical researcher may ask a participant in a clinical trial before enrolling that person. Informed consent is obtained from the fields of medical ethics and research ethics according to guidelines.

Informed consent can be said to have been given based on a reasonable understanding and appreciation of the facts, implications, and consequences of an action. Proper informed consent is rooted in respect for the dignity of a person. The individual concerned must have sufficient reasoning faculties and be in possession of all relevant facts to give informed consent. Disabilities of thought and judgment that can preclude informed consent include simple intellectual or emotional immaturity, high-stress rates such as post-traumatic stress disorder (PTSD) or extreme intellectual impairment, serious mental illness, addiction, extreme sleep deprivation, Alzheimer’s disease, or being in a coma. It is not always necessary to obtain informed consent. Where an individual is deemed unable to give informed consent, another person is generally authorized to give consent on his behalf, e.g., to a child’s parents or legal guardians and the mentally disordered conservators, or consent may be assumed through implied consent doctrine, e.g. when an unconscious consent is given.

In cases where the information provided to an individual is insufficient to form a reasoned decision, serious ethical issues arise. These cases are expected and avoided by an ethics commission or institutional oversight board in a clinical trial in medical research. There must be three components present for an individual to give valid informed consent: disclosure, capacity and voluntariness. Disclosure allows the researcher to include the information required to make an independent decision for each prospective subject and also to ensure that the subject understands the information given adequately. This latter requirement implies writing a written consent form in a lay language suitable for the subject population’s comprehension skills, as well as assessing the level of understanding through conversation (to be kept informed). Capacity refers to the subject’s ability to consider the information given and to make a sound opinion based on the possible implications of his / her decision. Voluntariness refers to the right of the subject to exercise his / her decision-making freely without being subjected to external interference such as coercion, manipulation, or undue influence.

Informed consent is difficult to determine, as neither the expressed consent nor the expressed understanding of consequences necessarily signifies that informed consent has been obtained. In the normal subtleties of human communication, an agreement can be inferred, rather than expressly conveyed verbally or in writing. Consent may not be legally possible in some cases, even if the person protests that he does indeed understand and wish. There are also structured tools for assessing the capacity to give informed consent, although there is currently no ideal instrument. Consequently, there is always a degree to which informed consent must be assumed or inferred based on observation, or knowledge, or legal dependence. This is especially the case in matters of sex or relation. In medical or formal cases, the rule is tacit approval by signing – usually legally relied upon – irrespective of actual consent. This is the case with certain procedures, like a “do not resuscitate” directive signed by a patient before the onset of their illness.

Autonomy has been recognized as a legally protectable interest and claimed as a by-product of protection for two interests – physical security as protected by rules against unconsented physical contact and physical well-being as protected by rules governing professional competence. In short, these interests can be called bodily integrity and individual self-determination, which reflect the patient autonomy principle. The right to physical integrity is expressed in common law by assault and battery statutes, both civil and criminal. This right, and the right to individual self-determination, also have constitutional underpinnings. Informed consent has evolved through litigation, and the definition will expand as common law jurisprudence expands. The transition can be traced from simple, voluntary, to informed consent. In 1767, the surgeon had to obtain consent from the patient in Slater vs. Baker and Stapleton before starting the treatment; and in 1914, voluntary consent was emphasized in Schloendorff vs. New York Hospital Society, i.e. the patient had to permit for the procedure. In the case of the Salgo vs. Leland Stanford Junior University Board of Trustees (1957), it was held that doctors have an affirmative obligation to disclose information. By referring to the above cases we can see how the informed consent doctrine has evolved.

According to the present interpretation of the doctrine of informed consent, patients must be adequately briefed by physicians about the costs, benefits and other aspects of care, and information about the right to obtain no care must also be provided. Competence, disclosure, understanding, voluntariness, and consent are the widely accepted building blocks of the concept of informed consent, based on the model of autonomy. In the above cases and lawsuits, the focus shifted from consent to treatment to the duty of the physician to disclose information. In cases involving consent, the element of disclosure of information has thus gained in importance. It is important to understand which existing legal protection protects the autonomy of the patient in analyzing the legal and ethical source of the consent concept.

What is the extent of disclosure required for the patient

The adequate information that the doctor must provide should enable a patient to make a balanced judgment as to whether he should or should not be submitting to a specific treatment. This means that the essence and method of the treatment and its intent, benefits and consequences should be revealed by a doctor. It should also include alternatives in case of significant risk and adverse effects of the proposed rejection of consultation. But there’s no need to clarify the remote or potential threats that can scare the patient from rejecting treatment or opting for fanciful or wasteful alternatives or contributing to psychological stress on the patient. The nature of disclosure must also depend on the patient’s physical and mental state. In Samira Kohli’s case, the Supreme Court has consciously preferred the concept of real consent, taking into account India’s medical and health care realities on the ground. 

Can consent for diagnosis be extended for performing the additional or surgical procedures

No new treatment may be done over what had been explained to the patient according to the Samira Kohli judgment. Even if the new treatment saves money and reduces the pain of the patient. Any supplementary act amounts to assault and service deficiency. The judgment gave allowance only for life-threatening circumstances. This point has several important ramifications for neurochirurgica practice e.g. during craniotomy for any brain surgery that performs duraplasty from facia lata or artificial dura. Cranioplasty with autologous or artificial sources can be read as an additional procedure. Similarly, the application of artificial dura leads to the injection of foreign material into the human body, thereby requiring alteration of the required consent when conducting corpectomy placing iliac crest bone graft or G bone are additional measures of similar grounds. Coiling a patient for aneurysm but landing in craniotomy requires the patient’s fresh approval unless life threatens that they can be received from the family. Unplanned removal of part of the brain (lobectomy) would amount to additional surgery during the operation. The court permits additional surgery in life-threatening cases or to protect the patient’s safety, leaving some unexplained explanations for that. Therefore we shall exercise our wisdom in our routine practice in understanding legal responsibilities by over-protecting the safe practice. 

Who should obtain consent

The judgment of Samira Kohli’s case made a side reference to this dimension. Although it did not pass any guidance on this, it left us with another gray area. It’s important to have the principal behind. Whether an unqualified person can provide all of the details and can make a patient understand all of the surgery’s relevant aspects. A house surgeon, interns or even a resident (postgraduate) are the ones who get the consent. Are all these workers trained and skilled in an informed / real consent to discuss all the aspects needed?

Who should sign the consent 

The patient must sign the consent unless the patient is minor, unconscious, or insane. Even in emergencies, unless the patient is unconscious, the consent offered by the major’s parents is void and amounts to negligence. The judgment in Samira Kohli’s case held that doctors who performed a hysterectomy and bilateral salpingo oophorectomy under anaesthesia were liable after the patient’s mother had consented. The patient claimed the operation was not life-saving and consented to diagnostic laparoscopy only. The removal of the uterus and ovary further deprived her of the chance of pregnancy. Of interest, the patient’s age was 44 years. There may also be several situations of this kind in neurosurgery, so we should keep this aspect in our mind while doing our duty. 

What is the role of the witness 

The Supreme Court in the Samira Kohli’s case failed to touch this topic. There had been many cases in which the patient suspected a forgery or pretended to sign it under doctor pressure, stressing without fully understanding the text. Consent from at least two individuals. One from the patient and another from a partner, parents or close relatives are preferable.

Case analysis: Samira Kohli vs. Prabha Manchanda

In India, medical negligence legislation is derived from English common law. A person harmed by medical negligence or malpractice may petition the justice system for disciplinary action under the Civil Procedure Code, the Code of Criminal Procedure (S 304 A, Indian Penal Code), the Consumer Protection Act (CPA), 1986, and the Medical Ethics Code Regulations, 2002. Jurisprudentially, there is no distinction between the Civil Code and criminal code negligence. It is the amount of harm caused that defines the level of liability in tort; in criminal code/law it is not the harm but the degree of negligence. An individual seeking financial compensation files a case under the CPA against medical professionals because it is the fastest way to remedy one’s grievance and get compensation. 

Outline of case facts

Samira Kohli, a 44-year-old single woman, met with Dr Manchanda on May 9, 1995, complaining about prolonged menstrual bleeding. She was admitted and signed the consent form for admission to hospital, medical treatment, and also surgery. The surgical consent form said, “diagnostic and practical laparoscopy. Laparotomy may be necessary. Under general anaesthesia, she was exposed to a laparoscopic examination. While Samira was unconscious and undergoing examination, Dr Lata Rangan came out of the operation theatre and took the patient’s mother’s consent for a hysterectomy. Dr Manchanda removed the uterus (abdominal hysterectomy), ovaries, and fallopian tubes (bilateral salpingo-oophorectomy) of the patient after obtaining her mother’s consent. Samira Kohli lodged a petition before the National Consumer Disputes Redressal Commission on 19 January 1996, demanding Dr Manchanda’s award of Rs 25 lakh. She argued that the doctor was unethical and that the experimental surgery was done without her permission, by which her uterus, ovaries, and fallopian tubes were extracted. The compensation sought was for the loss of her reproductive organs, reduced marriage chances, permanent harm to the body, loss of opportunity to become a mother, as well as painful emotional trauma. The National Commission dismissed the lawsuit, noting that the hysterectomy had been done with sufficient care and that the woman had received treatment at the clinic voluntarily. The supreme court had filed an appeal. The Supreme Court overruled the order passed by the National Consumer Dispute Redressal Commission and held the doctor liable for malpractice. The Supreme Court held that while additional surgery was of benefit to the patient in terms of saving time, suffering, pain, and expenses, this was no ground for defence. It gave additional details regarding consent and information disclosure.

The decision-making ratio, i.e. the rationale in this judgment for the decision, was rooted in assault and battery. The doctor performed an illegal abdominal hysterectomy – bilateral salpingo-oophorectomy (AH-BSO), without obtaining the patient’s express consent. While the practitioner has received permission from the patient’s mother, this is not deemed true because it amounts to trespassing on the patient’s bodily dignity and service deficiency. By fact, the right to self-determination and the fiduciary duty protect patients from unwarranted intrusions by doctors, such as surgery without consent. While the judges originally used the battery theory to address the violation of duty, the case was later treated under the principle of liability negligence, according to which compensation is offered to the claimant. And in medical situations, we can see the change in the principle of consent from one based on the battery to one focusing on the theory of negligence. Unintentional or reckless conduct is itself the source of responsibility according to the above principle. This means that an operation performed without consent is an act of negligence and therefore, the doctor is guilty. In this case, the judgment not only gave descriptions of clear consent for additional surgery but also expanded on the purpose of the judgment of consent and the nature of the disclosure of information. It also stipulated guidelines to be adopted in the Indian context by referring to British court cases. Understanding the nature of consent and the standard of disclosure of information allows the practitioner and the patient to analyze the position and significance given. It also helps to determine the degree of respect for the patient’s autonomy and represents the judicial role within the doctor-patient relationship as regards material knowledge and central authority.

In the Samira Kohli case, the debate initially focused on battery, then shifted its attention to the theory of liability negligence. Indian courts concerned with medical negligence cases requiring consent follow the legal requirement of disclosure of knowledge, as the British courts in the Montgomery vs. Lanarkshire Health Board, case 2015. In this case, the reasonable person disclosure standard was applied as opposed to the professional standard. Indian courts do not apply the rational person standard or the material risk standard which requires a physician to disclose all the information that an individual needs to make an informed decision on whether to undergo a particular treatment. The fair norm for an individual is based on the self-determination principle. They followed this standard in Canterbury vs Spence. The philosophical basis for advancing from the reasonable physician standard to the reasonable person standard for disclosure of the information is the promotion of the ethical ideal of patient autonomy. On the other hand, the professional disclosure standard reinforces physician paternalism, which impinges upon the autonomy of the patient. That approach was adopted in the UK before the 2015 case of the Montgomery vs Lanarkshire Health Board. In this case, the reason given for departing from the approach of the earlier rulings was ‘the responsibility of the doctor to inform her patient of the risks of the proposed treatment fall beyond the scope of the Bolam examination’ One of the questions considered in the Samira Kohli case was ‘whether the respondent is guilty of the tortious act of negligence/battery amounting to a deficiency in service, and the judge stated it was an unwanted invasion, and the doctor did not get consent.

The judgment was considerate towards doctors, noting that the respondent acted in the patient’s best interest. In the case of Samira Kohli, consent was seen as a legal tool for establishing service deficiency and directed physicians to respect the bodily integrity of the patient by stating the rationale for judgment under assault and battery. But the guidance is given in the judgment regarding the disclosure of “adequate material,” the decision to apply the Bolam test and the approval of the “true consent” from the UK represent the supremacy of the professional disclosure standard. And there was also no mention or highlighting of the physician’s obligation to reveal confidential details to the patient. In this case, the judge agreed to compensate the victim for lack of service, which relates to physical harm to the body. Thus, this case analysis indicates that the real or true consent policy was a tool to protect the bodily dignity and physical wellbeing of the patient. Physical well-being is considered the primary protected interest, and not the right of the patient to knowledge or choice of consent. The right of the patient to relevant knowledge is undervalued, which indicates that the ethical norm underlying respect for the autonomy of the patient is taken over or caught within the context of the physical health of the patient.

Conclusion

The Bolam test was applied in the Samira Kohli case and professional standards were used when considering the definition of actual or genuine consent and the quality of disclosure of information. When we examine the case of Canterbury and the cases of Bolam, Sidaway and Montgomery, we see that the major factors separating each case’s approach to consent were the “risk disclosure” requirement and the physician’s “duty” to reveal sensitive details. In the cases of Canterbury and Montgomery, the right to information of the patient was emphasized. The professional medical standard of disclosure of information was found inappropriate, and importance was attached to the choice of the patient. Medical judgments and decisions should be distinguished from the value judgments of the patients. Therefore, doctors should be facilitators who help patients make decisions by sharing information material to them. Patients’ autonomy is respected when their choices are given importance, and when emphasizing the “duty” of the physician to disclose information.

As for the Samira Kohli case guidelines on the knowledge disclosure standard, by giving priority to the implementation of the professional disclosure standard, the value of the patient’s preference has been evaded. Based on this case analysis and the other court cases referred to, we cannot deny patients the right to information on socio-economic and cultural grounds (as mentioned in the case of Samira Kohli), because the ‘duty’ of disclosing information should be distinct from the medical standards/custom and practice. For patients to exercise their choice, their right to make their own decision sets the limit of the obligation to reveal material for information. Thus, emphasizing the ethical and legal principle of ‘duty’ to disclose material information about physicians, and applying information standard for patient disclosure, protects and respects the choice of the patient.

References

• http://www.annalsofian.org/article.asp?issn=0972-2327;year=2016;volume=19;issue=5;spage=9;epage=14;aulast=Agrawal
• https://ijme.in/articles/patient-autonomy-within-real-or-valid-consent-samira-kohlis-case/?galley=html
• http://medind.nic.in/icf/t08/i2/icft08i2p105.pdf

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