Informed consent to clinical research in India: A private law remedy

Abstract

There is a well-established common law doctrine for ascertaining information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship in India. India, however, is not exceptional in this regard. Common law countries like the United States and Canada at most have sparse, non-systematised, criteria for such cases; arguably, a doctrine for research is at its nascent stage. But the adequacy of the existing criteria for settling informed consent claims in research has hardly ever been discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article discusses both. The article examines case law from India and other common law jurisdictions that hint at developments in this area. It suggests that Indian courts need to move abreast with other jurisdictions to better protect India’s patients and research participants.

Keywords

India informed consent legal doctrine common law protection of research participants health research clinical trials

Introduction

India’s research industry has been subject to increased scrutiny, precipitated by numerous incidents of unethical trials being reported in the national and international media. The alleged victims of these trials either did not consent to participate in these trials at all or gave inadequate consent. Most of the research studies that were under scrutiny had been given ethical clearance to proceed, but the procedure of consent post-clearance was found to be deficient.¹ No substantial remedial steps, except suspension of some trials, were taken. Yet, could these victims claim a remedy in court under private law? Some might be quick to assume that there is a clear legal answer to this question, but there is not.

There is well-established common law doctrine for establishing the adequacy of information disclosure in informed consent claims within the treatment context that governs the doctor–patient relationship. But there is no such doctrine in clinical research governing the researcher–participant relationship. India, however, is not exceptional in this regard. Common law countries like the United States and Canada have, at best, sparse, non-systematised criteria for such cases; arguably, a doctrine of informed consent for research is at a nascent stage. But the adequacy of the existing criteria for resolving informed consent claims in research is rarely discussed. Furthermore, a specific discussion on the applicability of this ‘nascent doctrine’ to India is non-existent. This article examines both of these issues.

The article is divided into four parts. The first section briefly outlines the clinical research context and regulation pertaining to informed consent in India and explains the relevance of the article. The second section gives an overview of the current Indian precedent dealing with the lack of informed consent within the treatment context. It also considers the feasibility of its applicability to the research context. Due to the absence of case law on the lack of informed consent in research in India, the third section engages in a normative discussion on how an Indian legal doctrine of informed consent in treatment can be developed around clinical research. This is based on an analysis of case law from other common law jurisdictions. The fourth section discusses the limits of law in dealing with informed consent in research within the larger social context of India.

Framing the issue

India became one of the preferred destinations for globalised clinical trials because conducting a trial in India can potentially reduce the cost of trial by up to 60% due to cheap labour, low infrastructure costs and easier access to participants.² In the early 2000s, with increasing policy support from the Indian government, the global pharmaceutical industry became interested in moving its trial operations to India.³ In 2005, the government amended Schedule Y of the Drugs and Cosmetics Rules 1945, appended to the Drugs and Cosmetics Act 1940. This statute regulates the import, manufacture, distribution and sale of drugs and cosmetics in India. The amendment of Schedule Y in 2005 established the guidelines for the conduct of clinical trials in the country.⁴ Provisions were made in the Schedule to ensure that patients and volunteers participate in studies only after a complete and proper understanding of the investigative study. An elaborate informed consent process, along with the responsibilities of Institutional Ethics Committees, clinical investigators and trial sponsors, was outlined in Schedule Y.

To complement Schedule Y, the Indian Council of Medical Research (ICMR), the apex body for the formulation, coordination and promotion of biomedical research in India, updated the ethical guidelines for human subject research in 2006, which were first released in 2000 and updated again in 2017.⁵ India adopted the Good Clinical Practice (GCP) guidelines (originally released by the International Conference on Harmonisation) in 2001; these guidelines prescribe the ethical and scientific quality standards for designing, conducting and recording trials that involve the participation of human subjects.⁶ The GCP guidelines lay down an elaborate consent process that is expected to be followed by researchers.⁷ Despite being the primary sources for governing the ethics of clinical research in India, the ICMR and GCP guidelines lack enforceability. Failures to adhere to guidelines, at the most, lead to either suspension of trial or disciplinary hearings.⁸ Schedule Y is the lone legal source that makes informed consent mandatory for clinical research in India. However, it does not specify the repercussions for failure to observe the procedures therein. This lack of penalty for failure to take (adequate) informed consent from participants in research has led to abuse.⁹ So much so that in response to the Supreme Court’s inquiry into why the government failed to take action against unethically conducted foreign-sponsored trials in 2015,¹⁰ the government acknowledged that ‘[a]s of now, there are no specific penalties for provisions relating to clinical trials under the [Drugs and Cosmetics] Act’.¹¹

To chart a brief history of unethical clinical research in India, before 2005, one finds only a few documented instances of research conducted without the informed consent of research subjects in India.¹² However, post 2005, after the sudden growth of the clinical research industry,¹³ numerous commentators started alleging regulatory problems in clinical trial regulation in India and casting doubt over the ethics of some of the trials.¹⁴ A number of incidents of trials with inadequate or no consent from participants came to be reported in the Indian and the international media between the years 2000 and 2010.¹⁵ Chief among them were the Indore trials,¹⁶ trials involving Bhopal Gas Tragedy victims¹⁷ and the human papilloma virus vaccine (Gardasil and Cervarix) trial.¹⁸ Some commentators called the practice of trials in India by foreign pharmaceuticals and research centres ‘the new colonialism’.¹⁹ The public outrage over the allegedly unethical trials culminated in a Public Interest Litigation (PIL).²⁰

In 2012, prompted by a series of unethically conducted trials reported in the media, the non-government organisation (NGO) ‘Swasthya Adhikar Manch’ (Health Rights Forum) filed a petition in the Supreme Court of India. The PIL titled Swasthya Adhikar Manch v. Union of India ²¹ (SAM case) was brought before the Supreme Court of India asking the Court to intervene in the matter of illegal and unethical trials being conducted on adults, children and mentally ill people in the country. The interim orders of the Supreme Court in this case have led to an overhaul in the legal and regulatory provisions related to the conduct of clinical trials in the country.²² In 2013, after hearing the SAM case, the Supreme Court observed that the ‘uncontrolled’ clinical trials of drugs on human subjects by multinational companies were wreaking ‘havoc’ in the country, noting that the government had slipped into ‘deep slumber’ regarding this ‘menace’.²³ The interim orders of the Supreme Court²⁴ made the Central Drugs Standard Control Organization (CDSCO), which is the national regulatory body for Indian pharmaceuticals and medical devices, issue a notification making audio–video recording (AVR) of informed consent proceedings during trials mandatory for all clinical trials.²⁵ The audio–video requirement for informed consent was later restricted to only ‘vulnerable subjects’,²⁶ but the notification did not carry a definition for vulnerable subjects. Moreover, the regulatory bodies decided that to protect the privacy of the participants in anti-human immunodeficiency virus or anti-leprosy drug trials, only audio (and no video) recording of consent would be required.²⁷

In the aftermath of the SAM case, clinical research in India is still governed under the Drugs and Cosmetics Act, 1940. However, an amended Schedule Y has introduced the requirement to make an AVR of informed consent mandatory for vulnerable subjects. Some guidelines were released by the CDSCO on how AVR is to be done to comply with rules regarding privacy and confidentiality of the research subjects.²⁸ However, there is ambiguity surrounding the vetting of the consent tapes and the definition of vulnerable subjects. Post the SAM case, new regulations pertaining to the conduct of trials were released, which led to a brief lull and a negative impact on the growth of the clinical research industry.²⁹ As things stand in 2020, no strict penalties have been introduced for the violation of ethical guidelines during the conduct of research, not even for violation of the legally mandated procedure for obtaining informed consent.

This background leads one to question the role of law in providing a suitable remedy to the victims of lack of informed consent in research. While informed consent is widely accommodated under tort law, the SAM case demonstrates a process – which is now considered a trend in India³⁰ – of constitutionalisation of private law. Before diving into the private law remedy for a lack of informed consent in treatment and research, I will first address why a constitutional approach to this problem does not suffice in providing an adequate remedy to victims of a lack of informed consent in research.

The constitutional approach and its limitations

If we frame informed consent within the narrative of constitutional rights, a research participant’s right to informed consent can broadly be placed under the right to autonomy. The Constitution of India provides for the protection of ‘personal liberty’ under Article 21, which also includes protection of personal autonomy. The Supreme Court has held personal liberty and autonomy to include ‘both the negative right not to be subject to interference by others and the positive right of individuals to make decisions about their life, to express themselves and to choose which activities to take part in’.³¹ Constitutional rights are usually enforceable by an individual vertically against state authorities.³² But constitutional courts in different jurisdictions have allowed for the application of rights horizontally, which means that an individual may enforce constitutional rights against non-state private bodies.³³ I make this point to suggest that if a claim based on the violation of the right to informed consent were brought before the courts³⁴ in India, as a violation of right to life and personal liberty, it would, in the first instance, only be maintainable against state actors.³⁵ However, the Supreme Court could impose an obligation upon the state to take necessary steps to ensure the observation of fundamental rights by other private individuals.

If horizontality is applied,³⁶ which the Supreme Court has shown an inclination towards but not quite fully endorsed for some rights,³⁷ the enforcement of fundamental rights could perhaps, someday, be directly extended to private non-state actors. As for now, the remedial avenue available by invoking fundamental rights enshrined in the Constitution of India is twofold – (X) to plead a writ against the state³⁸ or (Y) demand compensation from a government official, who in the process of doing his or her official duty violated a right that harmed the individual.³⁹

The first avenue, (X), was chosen by the petitioners in the SAM case. It must be noted that a violation of informed consent norms was not the sole cause of action in the SAM case and the petitioners sought a writ, in the public interest, against the state bodies.⁴⁰ It remains to be seen what a court would do where an individual (or a single person’s) petition claims a violation of the right to life due to a lack of informed consent in clinical trial participation. The court could, and probably might, direct the state to take steps towards controlling further violation of fundamental rights. Under the second avenue, (Y), damages can be claimed by a broader application of tort law against the state (via vicarious liability). But such a claim would require the proof that the violator was performing an act in official capacity, in the employment of the state, and the act in such capacity violated the fundamental right of the individual which led to harm or injury.⁴¹ This claim would be impossible to bring in a clinical trial organised and executed entirely by private actors. (Y) would only be possible in a government-run (or government-sponsored) trial or where an investigator was working in the capacity of an employee of the state.

Avenues (X) and (Y) are both unsuitable to trials that are conducted by private or foreign actors and also unsuitable for individual victims of lack of informed consent in research. Given that the constitutional approach is inadequate, we should favour the tort law option which already has a decent corpus of case law on informed consent. To further this claim, in the next section, I will analyse the current leading precedent on informed consent to treatment in India and extrapolate its application to the research context.

Law of informed consent in treatment

Here I will analyse how informed consent is understood in tort law in India. Other than the Consumer Protection Act 1986 (CPA), where doctors are treated as service providers and patients as consumers of such services and the lack of informed consent as a deficiency in service, there is no other statutory basis for a lack of informed consent claim in treatment.⁴² The standards for information disclosure as developed in the torts of medical negligence and battery form the corpus of the legal doctrine of informed consent.

In private law, a doctor can be liable for negligence if she fails in her duty to disclose the material risks inherent in the proposed therapeutic treatment or surgery and damage results from the failure to disclose.⁴³ Thus, the patient has the common law right to recover damages against the physician for failure to provide adequate informed consent.⁴⁴ Lack of informed consent cases may also fall under the torts of trespass to persons, namely, the tort of ‘battery’ in India. Most torts fall under two categories – intentional and unintentional torts.⁴⁵ To put it simply for the purposes of this article, negligence is an unintentional tort which can apply where a patient is not sufficiently informed about the risks inherent in the treatment and/or alternatives to the treatment, whereas battery is an intentional tort where the doctor intended to cause contact (touching) with the patient without the patient’s consent.⁴⁶ Thus, in order for a tort of battery to be established two conditions must be met, viz., (i) intentional unauthorised contact with the patient (trespass to person) and (ii) lack of patient’s consent. It is pertinent to note that ‘harm’ is not a necessary condition for an action under battery. A patient can recover for battery even if she is not harmed, provided that the doctor performs the medical intervention without the patient’s consent.⁴⁷ It is important to note the difference between these torts because there have been situations where a claim was erroneously identified under battery instead of negligence.⁴⁸ This often leads to dismissal of the case for inappropriate cause of action.

Indian case law on informed consent in treatment

The leading authority on informed consent in the medical treatment context in India is Samira Kohli v. Dr. Prabha Manchanda & Another. ⁴⁹ Samira Kohli, the petitioner, consulted with Dr. Prabha Manchanda, the respondent, regarding her prolonged menstrual bleeding. She was admitted to the respondent’s clinic where she signed the consent form for hospital admission, medical treatment and for surgery. The consent form for surgery described the procedure to be undergone by the petitioner as ‘diagnostic and operative laparoscopy. Laparotomy may be needed’.⁵⁰ The petitioner was subjected to a laparoscopic examination under general anaesthesia. While the petitioner was unconscious during her examination, the respondent’s assistant took the consent of the patient’s mother for a hysterectomy. After this, the respondent removed the patient’s uterus (abdominal hysterectomy), ovaries and fallopian tubes (bilateral salpingo-oophorectomy). The petitioner filed a complaint before the National Consumer Disputes Redressal Commission (NCDRC) under the CPA, claiming compensation of INR 25 lakh ⁵¹ from the respondent. Her complaint alleged that the doctor had been negligent and that the radical surgery, by which her uterus, ovaries and fallopian tubes had been removed, had been performed without her consent. The petitioner claimed compensation for the loss of her reproductive organs, irreversible damage to the body, loss of the opportunity to become a mother, diminished prospects of matrimony and emotional trauma. The NCDRC dismissed the complaint on the grounds that the hysterectomy had been performed with adequate care and that the patient had voluntarily sought treatment at the respondent’s clinic. Aggrieved by the order, the petitioner filed an appeal in the Supreme Court of India. The court overruled the order passed by the NCDRC and held that:

…there was no consent by the appellant for performing hysterectomy and salpingo-oopherectomy, performance of such surgery was an unauthorized invasion and interference with appellant’s body which amounted to a tortious act of assault and battery and therefore a deficiency in service.⁵²

The court, however, observed that even though the respondent’s act was in ‘excess of consent’,⁵³ the act was done in good faith and for the benefit of the petitioner. Consequently, the compensation that was directed to be paid to the petitioner was significantly less than claimed.⁵⁴ The following examines the relevance of this case to the research context.

Importance of the Kohli case and its applicability to the research context

Adequate disclosure of information is one of the essential elements of informed consent.⁵⁵ Courts in different common law jurisdictions use three distinct standards to assess information disclosure – the professional practice standard, the reasonable person standard and the less commonly used subjective standard.⁵⁶ The Kohli case dealt with two of these standards: the professional practice standard, also known as the Bolam test, and the reasonable person standard, called the Canterbury principle. Let us briefly review these standards before evaluating the Kohli case.

The US Courts of Appeals, District of Columbia Circuit’s decision in Canterbury v. Spence ⁵⁷ laid down the ‘reasonable person standard’, also called the Canterbury principle, which mandated the doctor to disclose all ‘material risks’ to a patient to indicate that the consent was ‘informed’. The US court held that:

[t]rue consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each. The average patient has little or no understanding of the medical arts, and ordinarily has only his physician to whom he can look for enlightenment with which to reach an intelligent decision. From these almost axiomatic considerations springs the need, and in turn the requirement, of a reasonable divulgence by physician to patient to make such a decision possible.⁵⁸

Thereafter, the court laid down that the doctors had a duty to disclose all material risks to the patient with the exception of where disclosure of risks would pose a threat to the well-being of the patient. The court also defined ‘material’ risk, holding that a risk was material:

…when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.⁵⁹

The ‘professional practice standard’ for determining negligence and for assessing information disclosure was applied in the UK case, Bolam v. Friern Hospital Management Committee. ⁶⁰ Here, Justice McNair, giving his direction to the jury, stated:

[A doctor] is not guilty of negligence if he has acted in accordance with the practice accepted as proper by a responsible body of medical men skilled in that particular art.⁶¹

The wording of this direction came to be known as the Bolam test and for some time was treated as applicable to a doctor’s duty to disclose the risks of proposed treatment.⁶²

The English courts have now moved beyond the Bolam test. In a 2015 case, Montgomery v. Lanarkshire Health Board,⁶³ the UK Supreme Court, while deciding on the issue of whether a consultant obstetrician and gynaecologist was negligent in managing the pregnancy of Mrs. Montgomery, made way for a fresh legal understanding of the concept of informed consent. The seven Judge Bench allowed Mrs. Montgomery’s appeal after a careful analysis of the post-Bolam cases on informed consent. Following Montgomery, the Bolam test would no longer apply to disclosure for consent as it has been replaced with a more patient-centred test.⁶⁴ This means that, in the UK, the standard has shifted from the paternalistic ‘what a reasonable practitioner would do’ to a patient-autonomy enhancing ‘what a reasonable person would want to know’. Montgomery’s implications for the research context and on the doctrine of informed consent in India will be addressed in the fourth section. But first this article analyses the Kohli judgment evaluating its suitability as a benchmark to decide future cases arising from a lack of informed consent in research.

Kohli, Bolam and India

The contribution of the Kohli case to the jurisprudence on informed consent in India is noteworthy for two reasons: (1) it rejects the Canterbury principle, or the reasonable person standard, for information disclosure and (2) it adopts a socio-economic line of reasoning to prefer the Bolam test over Canterbury. The judges in this case noted:

In India, [the] majority of citizens requiring medical care and treatment fall below the poverty line. Most of them are illiterate or semi-literate. They cannot comprehend medical terms, concepts, and treatment procedures. They cannot understand the functions of various organs or the effect of removal of such organs. They do not have access to effective but costly diagnostic procedures. Poor patients lying in the corridors of hospitals after admission for want of beds or patients waiting for days on the roadside for an admission or a mere examination, is a common sight. For them, any treatment with reference to rough and ready diagnosis based on their outward symptoms and doctor’s experience or intuition is acceptable and welcome so long as it is free or cheap; and whatever the doctor decides as being in their interest, is usually unquestioningly accepted. They are a passive, ignorant and uninvolved in treatment procedures. ⁶⁵ (My emphasis)

This line of reasoning, where poverty and poor conditions of literacy are automatically assumed to render an individual ‘passive’ and ‘ignorant’ about one’s treatment decisions, is dangerously paternalistic. Although the judges in the Kohli case have shown great awareness and sympathy for the real conditions of patients in India, they have reiterated the support for paternalism that the Bolam test seemed to exemplify with its ‘doctors know best’ approach.⁶⁶ While making observations about the appalling conditions of patients in India, the judges in this case also questioned the relevance of informed consent in a country like India. They opined:

The poor and needy face a hostile medical environment inadequacy in the number of hospitals and beds, non-availability of adequate treatment facilities, utter lack of qualitative treatment, corruption, callousness and apathy. Many poor patients with serious ailments (e.g. heart patients and cancer patients) have to wait for months for their turn even for diagnosis, and due to limited treatment facilities, many die even before their turn comes for treatment. What choice do these poor patients have? Any treatment of whatever degree, is a boon or a favour, for them. The stark reality is that for a vast majority in the country, the concepts of informed consent or any form of consent, and choice in treatment, have no meaning or relevance.⁶⁷ (My emphasis)

The conclusion of the Court here is problematic on at least two grounds. First, informed consent is not a conditional right. Holding that informed consent has ‘no meaning or relevance’ for the poor owing to the lack of treatment facilities implies that informed consent is a luxury afforded to those who are not poor and have access to medical facilities. Yet all patients and research participants, whether rich or poor, have the right to be informed about the treatment or study and have the right to either consent or not consent depending on that information. Second, the judges in this case lost an excellent opportunity to reaffirm the duty of care owed to patients irrespective of their backgrounds. Even though the premise of the entire paragraph is true and shows that the judges are aware of the ground realities in India, the conclusion ought to have been in favour of the protection of every patient’s autonomy. If this reasoning were to be extended to the research context, it would not stand, as no one would condone a position that informed consent has no meaning or relevance for the poor people volunteering for clinical research. In fact, the situation is quite the opposite for research; there is a need for bettering the informed consent process to protect the poor and vulnerable. For now, when the time comes for the courts to deal with cases arising out of lack of informed consent in research in India, they will first look at the law of informed consent within the treatment context to draw parallels with the research context, and here they would find an obiter dictum that called informed consent ‘meaningless’ and ‘irrelevant’ for poor patients.

On the matter of informed consent from the perspective of the ‘takers of consent’, the judges in Kohli opined:

The position of doctors in government and charitable hospitals, who treat them, is also unenviable. They are overworked, understaffed, with little or no diagnostic or surgical facilities and limited choice of medicines and treatment procedures. They have to improvise with virtual non-existent facilities and limited dubious medicines. They are required to be committed, service oriented and non-commercial in outlook. What choice of treatment can these doctors give to the poor patients? What informed consent can they take from them? ⁶⁸ (My emphasis)

Although the premise of this paragraph is sympathetic, the Court’s observations lead to unsound implications. If this rhetorical observation by the court were to be advanced further, it would mean that the lack of resources available to a doctor would absolve the doctor from the duty to take informed consent from her patients. If this reasoning were to be extended to the research context, it would mean absolving researchers from their duty to take informed consent because of time constraints, funding problems, lack of administrative support and so on. This, however, is neither the established legal position nor the ethical one. Fortunately, these observations were made as obiter dicta, subsequent to which the court chose Bolam over Canterbury citing the ‘ground realities’ in India. It said:

We have, however, consciously preferred the ‘real consent’ concept evolved in Bolam…in preference to the ‘reasonably prudent patient test’ in Canterbury, having regard to the ground realities in medical and health-care in India. But if medical practitioners and private hospitals become more and more commercialized, and if there is a corresponding increase in the awareness of patient’s rights among the public, inevitably, a day may come when we may have to move towards Canterbury. But not for the present.⁶⁹ (My emphasis)

This reasoning is equally questionable. This implies that for the court to have considered an autonomy-enhancing standard of information disclosure, there would need to be some evidence that Indian citizens were more aware of their rights as patients.⁷⁰ The ‘ground realities’ of India observed by the court show that there is an asymmetrical power relationship between a doctor and a patient. The court either misconstrues these ground realities or misconstrues the Bolam test. For Bolam enhances this asymmetry, particularly if there is a poor, or possibly not highly educated or unaware, patient being treated by a highly educated and well-regarded doctor with expert colleagues in tow. Bolam makes it easier to disregard the rights of poorer patients.

If we look at the research context in India, we will find that most privately sponsored clinical research is commercial by nature and not all participants are aware of their rights.⁷¹ Nevertheless, the difference between research and treatment is such that the unaware participants need to be given more information related to the study by the researcher. The Bolam test in affirming that the ‘doctor knows best’ is quite redundant for the research context as it goes both against the ethical guidelines and informed consent process required by the statute that governs clinical research in India.⁷² Albeit that the researcher/investigator of a study might ‘know best’ in terms of what the likely risks are, he or she is nonetheless required to disclose all relevant information about the study to the participant. Such disclosure cannot be measured against what other professionals in the field do considering that every research study is different. Furthermore, in most studies, some of the risks are unknown; in fact, most studies are conducted on human subjects to uncover risks involved in experimental procedures or drugs. Therefore, the potential risks that are generally disclosed in a similar study of a similar drug might be completely different from potential risks involved in the study of another. As such, and by the farthest stretch, if the courts were to consider the Bolam test as applicable to the research context, they could look at the ICMR or GCP ethical guidelines as the professionally accepted standards in human subject research. Given that most guidelines are released by professional bodies headed by people from a given profession, they can safely be regarded as the codified norms that ought to govern the behaviour of those professionals. This is perhaps the only approach that could somehow accommodate the Bolam test within the research context.

Let us now look at another reason given by the court in the Kohli case to prefer the Bolam test to the Canterbury principle. The court noted:

People in India still have great regard and respect for Doctors…There is an atmosphere of trust and implicit faith in the advice given by the Doctor. The Indian psyche rarely questions or challenges the medical advice. Having regard to the conditions obtaining in India, as also the settled and recognized practices of medical fraternity in India, we are of the view that to nurture the doctor-patient relationship on the basis of trust, the extent and nature of information required to be given by doctors should continue to be governed by the Bolam test rather than the ‘reasonably prudential patient’ test evolved in Canterbury. It is for the doctor to decide, with reference to the condition of the patient, nature of illness, and the prevailing established practices, how much information regarding risks and consequences should be given to the patients, and how they should be couched, having the best interests of the patient.⁷³

All the justifications given by ethical theorists to strengthen informed consent by increasing dialogue between doctor–patient/researcher–research subjects, such as protection of patients/subjects and restoration of trust, were taken by the judges in this judgment and formulated into reasons for supporting the paternalistic Bolam test. The court reinforced the paternalism, which has now been rejected by most common law jurisdictions, in stating that for the Indian patient, a doctor should make decisions as other doctors see fit. One cannot help but note that not one sound legal reason was given by the Supreme Court for rejecting the pro-patient Canterbury principle. Perchance the judges should have taken note of the comments made by Shepherd et al., regarding legal justice in favour of patient rights; they wrote:

Law, especially in the realm of litigation, involves questions of justice. It can be no more pro-patient than it can be pro-plaintiff or pro-defendant. But if we return to the idea of patients generally – rather than the specific patient – being benefited or at least not harmed by a particular ruling, or to the idea of law that supports healing relationships, then an explicit normative stance in favour of patients does not seem quite so out of keeping with more general notions of legal justice.⁷⁴

A final aspect of the Kohli case worthy of note is that the court used this case as an opportunity to clarify its position on medical negligence and the test for information disclosure, but it imposed liability on the respondent under the tort of battery. Referring to some established precedents regarding the tort of battery,⁷⁵ the judges in the Kohli case held that:

Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure.⁷⁶

Thus, the court in the Kohli case held that the lack of consent for hysterectomy and SPO was ‘an unauthorized invasion and interference with appellant’s body’, thereby holding the respondent liable under the tort of battery.

The Kohli case is the current precedent on the law of informed consent in India; so far, it has not been challenged.⁷⁷ Briefly, the court held that a reasonable practitioner should decide what a patient must know regarding her treatment rather than the patient herself because Indian patients are poor and deeply trust their doctors. Therefore, to nurture the trust between the poor Indian patient, who is lucky enough to get any treatment, and the doctor, who is overworked, the Bolam test was more suited to the Indian reality.

The Kohli case demonstrates India’s legal position on informed consent cases in the treatment context, but it is unclear whether individuals have a private right to action to receive damages for lack of informed consent in clinical research in India. So far, there has not been a single reported case utilising that cause of action.⁷⁸ This maybe because as commentators have suggested, there is not much tort litigation in India due to the high costs of court action.⁷⁹ It is true that tort law development has been somewhat patchy in India.⁸⁰ Even though there is a significant body of case law on medical negligence,⁸¹ most of it derives from foreign precedents and there is, to the author’s knowledge, no precedent on lack of informed consent in clinical research as the sole cause of action. Therefore, if someone wanted to employ a private law remedy under tort law in India for lack of informed consent in clinical research, the courts would be likely to refer to how the private right to action is invoked in other common law jurisdictions. Let us first find out if such a private right to action for lack of informed consent is recognised in other common law jurisdictions.

Informed consent to research in the United States and Canada

There has been a steady increase in lawsuits in the United States based on investigators’ failure to obtain informed consent.⁸² Despite such an increase in lawsuits, scholars claim that the courts have rarely succeeded in extending a right of private action to lack of informed consent in clinical research.⁸³ An analysis of case law from the United States confirms this claim. For instance, in Wright v. Fred Hutchinson Cancer Research Center,⁸⁴ the Cancer Research Center and its investigators were sued by family members of cancer patients who had participated in a series of clinical trials which led to several deaths. The US District Court for the Western District of Washington granted the Center’s motion for judgment in its favour, the jury finding that the trial participants had given their consent.⁸⁵ The court held that the breach of informed consent in clinical trials is not deemed a violation of a federal right as defined by law. It also held that there was no statutory basis for a private right of action that the petitioners sought to assert given that alternate tort or procedural remedies were available to the petitioners.

If the Wright case was to be applied in India, the court could find a similarity in the statutory absence of a right to private action. The Drugs and Cosmetics Act does not prescribe any remedial clause for the failure to observe informed consent procedures for clinical trials. Moreover, a potential claim for lack of informed consent leading to violation of a fundamental right guaranteed by the Constitution of India would not stand if an Indian court was to consider what the US court in Wright noted:

…[the] defendants’ failure to make disclosures necessary to the informed consent process in a therapeutic, experimental setting, does not implicate rights that are so rooted in the tradition and conscience of our people as to be ranked as fundamental. A doctor’s tortious failure to obtain informed consent is not a threat to our citizens’ enjoyment of ordered liberty, even when the doctor is employed by the state.⁸⁶

However, there have been cases where courts in the United States have held that research participants can bring a tort claim for lack of informed consent in the research context. But these cases have either involved particularly vulnerable population groups or investigators failing to disclose information about foreseeable risks in their research.

In an example of litigation concerning vulnerable populations, Grimes v. Kennedy Krieger Institute ⁸⁷ involved non-therapeutic health research on children. Researchers from Kennedy Krieger Institute (KKI) conducted a 2-year study to measure and compare lead dust levels collected in housing with lead levels in blood samples drawn from children living in those homes. In this case, the trial court ruled in favour of the researchers, but the Maryland Court of Appeals reversed the decision. The Court of Appeals held that the informed consent requirement under the Common Rule⁸⁸ created a duty of care that arose out of a ‘special relationship’⁸⁹ between the investigator and research participant and a breach of such duty was actionable under state law.

This case was unusual in finding a duty where the research did not seem to have introduced participants to additional risks (they were already living in the premises before the study). The duty was seemingly based on a ‘failure to warn’ when the risk was not introduced by the research itself.⁹⁰ The court reiterated the Canterbury principle and held that the study conducted by KKI lacked the fully informed consent of participants and the research did not comply with federal regulations.

It is important that we analyse this case further to determine whether it extends a private right to action in all research-based cases. The court determined that a ‘special relationship’ existed in this case because it involved healthy children who required surrogate consent to participate in the study. Moreover, the research was non-therapeutic (gave no direct benefit to the research participant) and there was more than ‘minor’ risk involved. These factors made the case ‘special’. Furthermore, the court said, ‘whether a duty of care existed between the parties is a question to be determined by the trier of fact on a case-by-case basis’.⁹¹ Koch suggests, and I concur, that since no other court in the United States has found such a ‘special relationship’ between investigators and research participants, ‘it would be presumptuous to assume, based on this single court’s narrow holding, a general private right of action for participants for failure to disclose the risks and benefits of a research protocol’.⁹² I would argue that if such a case were to come before a court in India, it ought to follow a similar ‘case-by-case’ strategy to determine the nature of relationship between the research participant and the researcher.

Also notable in the US jurisprudence are cases confirming a heightened duty of disclosure in cases of research as opposed to treatment. In Whitlock v. Duke University,⁹³ the plaintiff suffered permanent organic brain damage during a simulated deep dive experiment. He claimed that the University was negligent in its duty to fully inform the participant about the foreseeable risks. The court held that the degree of required disclosure of risks is higher in the non-therapeutic research context than in the treatment context.

If a case based on a similar cause of action were to arrive before a court in India, the court should reconsider its standard for disclosure of information.⁹⁴ As noted earlier, the Bolam test does not do justice to the relationship between a research subject and an investigator or researcher. The nature of scientific research into new entities is such that few investigators would be able to comment on the foreseeable risks involved in another investigator’s research. If the risks are unknown, as they often are in research, then research subjects need to be explicitly warned about this. This negates the need for expert opinion of other investigators on foreseeable risks. Bolam, in relation to information disclosure, has largely been abandoned in other common law jurisdictions. If a court in India were to use a pre-existing standard for information disclosure from the treatment context for dealing with a case under the research context, it ought to choose between Canterbury or Montgomery. Then, at least, the standard of disclosure would be determined by the yardstick of what a reasonable person in the participant’s position ought to have known about the experimental procedure.⁹⁵

Also requiring a nominally higher degree of disclosure for research rather than the treatment context, the Canadian Court of Appeal in Saskatchewan in Halushka v. University of Saskatchewan et al.⁹⁶ was of the opinion that the duty of researchers to participants ‘is at least as great as, if not greater than, the duty owed by the ordinary physician or surgeon to his patient’.⁹⁷ Halushka involved a student who participated in a test of a new anaesthetic. He signed a consent form and was informed that the test involving the new drug was safe. During the test, the plaintiff suffered from a cardiac arrest but was resuscitated. The plaintiff sued the defendants for trespass to person and negligence. The plaintiff’s claim for both trespass and negligence succeeded at the original trial. He was allowed to recover damages from the defendants, and the Court of Appeal upheld the verdict for damages but only under trespass, not negligence. While reaching its decision, the court seemed to have construed the non-disclosure as so substantial and misleading that the student had in effect given no consent. The court noted that in medical cases, an actionable trespass to person is said to have occurred if consent is not informed and freely given. The court also went into the risk versus benefit analysis of the research. It held that since the plaintiff was simply a research subject who received no therapeutic benefit from the research, he was entitled to a complete and frank disclosure of all facts, probabilities and opinions, which a reasonable person might be expected to consider before consenting to the test.⁹⁸

Halushka considered the differences between the research and treatment context and suggested that the standard of information disclosure under informed consent was a little higher than that required for in treatment. This was because there could be no case for exception to omit information for the welfare of the research participant, like a doctor could for the benefit of the patient. Morreim, while writing about the legal treatment of informed consent in research, has written about the need for courts to understand the difference between the two contexts. He clarifies that ‘research injuries are [not] somehow worse (or better) than medical malpractice, or that we need to augment (or diminish) the available causes of action against research errors’.⁹⁹ He thinks, and I agree, that courts need to be erudite and clear about research being a different context than treatment, particularly if they are to build a satisfactory foundation by which to guide conduct in research.

Halushka also attempted to make a distinction between the tort of battery and negligence quite unlike the Indian court in Kohli. It appears that the court in Kohli was open to the idea of determining a liability under either negligence or battery, whichever suited the facts of the case more.¹⁰⁰ However, Halushka was not entirely sharp on this distinction as it is not clear how grave the non-disclosure would need to be for there to be no effectual consent.

The choice between torts of battery and negligence can be blurry in some cases of inadequate consent as it largely depends on the degree of non-disclosure of information. However, it is clear that battery is the appropriate tort for non-consensual cases of research. A leading precedent for non-consensual clinical research is Mink et al. v. University of Chicago ¹⁰¹ where the plaintiff along with a thousand other women was given diethylstilbestrol (DES) as part of a double-blind study to study its effect on preventing miscarriages. The plaintiffs were neither told that they were to be a part of an experiment nor were they told that they were being given DES, as such they alleged that the drug caused their newly born daughters to develop cervical abnormalities and that it led to an increased risk of cancer in them and their daughters. The court held that the cause of action that could succeed was battery since there was a complete lack of consent. Here again, as in Halushka, the court differentiated between the torts of battery and negligence holding that ‘where the patient has not consented to the treatment, it is meaningless to ask whether the doctor should have revealed certain risks necessary to make the consent an “informed” one’.¹⁰²

Taking stock of the position on lack of informed consent in research, the US courts have recognised a ‘special relationship’ between investigators and research subjects in a case involving children, even where the researchers had not introduced the risks the children were exposed to, and they have recognised that a higher degree of disclosure is needed in research cases. They have also held that lack of informed consent does not provide a private right of action under federal regulations (Common Rule) and if an alternative remedy exists (as it does in tort); lack of informed consent is not a violation of due process (violation of life and person liberty in India).¹⁰³ The Canadian position is that a higher degree of disclosure is needed for research, especially for non-therapeutic research in which the risk is higher and which is of little benefit to the research subject. It is pertinent to note that each of these cases had different facts and completely different claims, which shows that the right to recover for lack of informed consent in research is not as established as it is under treatment.

All these cases show that a court in India would have the option to entertain a claim arising out of lack of informed consent in research under the torts of battery or negligence (depending on the facts of the case). As for a private right to action for lack of informed consent in research, whether arising from a statute or other regulatory provision in India, the court would have a difficult time finding one. If a claim under lack of informed consent is filed in the higher courts as a violation of a fundamental right, it will remain at the discretion of the court to determine whether the lack of informed consent amounted to a violation of the right to life and/or personal liberty (a position rejected by the US court in Wright).

Having outlined the position of the Indian courts on informed consent and suggested the lessons that could be learned from some legal cases from United States and Canada, I acknowledge that simply focusing on law in this area is unlikely to solve the problems with the actual process of informed consent.¹⁰⁴ But the development of a clear and concise legal remedy is required to tackle grievances arising out of a lack of informed consent in research. Nevertheless, there are some limitations that need to be accounted for in any discussion on legal remedies. The next section will draw out some of these limitations.

Some limitations

In the remaining sections, I will address one general and two context-specific limitations pertaining to development of a legal doctrine for a lack of informed consent in research in India.

Limits of tort law in general

It is generally accepted that the legally recognised right to give a consent which is informed is aimed at protecting the autonomy of the research participant. But commentators question the sufficiency of the present legal doctrine with regards to protection of autonomy. Morreim, for example, is of the opinion that the standard legal doctrine of informed consent does not sufficiently protect autonomy where there is no demonstrable physical harm to the individual:

[B]ecause standard informed consent doctrine usually limits recovery to cases featuring a physical or other separate injury, it can fail to honor human autonomy in cases where someone’s right to choose has been abused without demonstrable physical damage. If this is a problem in ordinary medicine, it is even more so in the research setting.¹⁰⁵

I do not think that this criticism is sound to the extent that there are claims that can succeed under the tort of battery without a demonstrable physical damage.¹⁰⁶ Moreover, even though it is rare and often difficult to claim, people with no physical injury after having proven ‘infliction of emotional distress’ have also been able to recover damages under tort law.¹⁰⁷ Serious dignitary harms¹⁰⁸ can also be rectified under constitutional rights. Yet some commentators have demanded a new dignitary tort for lack of informed consent in research.¹⁰⁹ While the right to recover damages for lack of informed consent in research is not as established as the right to recover under treatment, and there is a need for clarity in law pertaining to the treatment of lack of informed consent in research, there is arguably enough flexibility under tort law to address the different nature of the investigator–subject relationships.¹¹⁰ An example of this sort of flexibility is the Grimes case, in which the court acknowledged the wide knowledge gap between investigators and research subjects and found a ‘misalignment of interests’.¹¹¹

Limitations of the law of informed consent in India

In addition to the options mentioned in the third section, there is another, albeit indirect, route that an Indian court might prefer to use to determine claims arising from a lack of informed consent in research, especially considering that more than 10 years have elapsed since Kohli. In the second section, it was noted that the UK, through Montgomery, has moved away from Bolam towards a more patient-centred standard of information disclosure. The Indian Supreme Court could, therefore, reject Bolam test in favour of Montgomery (despite rejecting Canterbury in 2008) in the future medical negligence or battery cases and then extend Montgomery to health research cases. Although this move would have some advantages, the next section will explain why it seems not entirely fitting (legally, ethically and practically) for the research context.

Why not Montgomery?

At first sight Montgomery may be perceived as a step forward in dealing with negligence cases based on failure to adequately inform a research participant. Scholars usually agree that Montgomery is more patient-centred than its predecessor Bolam and that it depicts a steady move towards informed consent becoming a more personalised process in not just treatment but also in research.¹¹² It is well established that the informed consent process in clinical trials, from counselling sessions until the end of research, requires a continuous dialogue between researchers and participants. Montgomery recognises that a ‘doctor’s advisory role involves dialogue’¹¹³ and if extended to research, information to participants would need to be in the form of a dialogue with participants themselves determining what information they would want to be provided for the research.

However, Montgomery is not devoid of criticism from scholars and medical practitioners alike.¹¹⁴ One main problem concerns the standard for the assessment of disclosure of material risks which, according the court, ought to be ‘fact-sensitive, and sensitive also to the characteristics of the patient’.¹¹⁵ This is close to making the standard of information disclosure subjective to an individual patient’s/participant’s need for information. Although autonomy-enhancing, the subjectivity standard risks cases where research participants refuse full information. As noted earlier, research involves uncertainty in risks, and it is these risks that might cause harm to a participant. Given that all guidelines in human subject research require complete disclosure about known and unknown risks in a study, Montgomery appears to be partly untenable for the research context.¹¹⁶ Furthermore, Montgomery supports therapeutic privilege to an extent, holding that a doctor is ‘entitled to withhold from the patient information as to a risk if he reasonably considers that its disclosure would be seriously detrimental to the patient’s health’. This does not translate well into the research context for any research-related information, no matter how detrimental to the participant’s health, cannot be withheld from a participant without ethically and legally invalidating the participant’s consent to research.

Nonetheless, if extension of case law from treatment is the only option to deal with lack of informed consent in research, then despite its problems, Montgomery is better suited to research than Bolam in as much as it supports a dialogue-based patient-centred standard of information disclosure rather than a paternalistic one. Therefore, Indian courts have the option of rejecting Bolam in favour of Montgomery in forthcoming negligence cases and partly applying its ratio to lack of informed consent in research. For the near future, however, this option seems unlikely for three reasons: First, the Indian court in Kohli gave widespread poverty and trust in doctors as reasons to reject Canterbury’s patient-centred test and to retain Bolam. These conditions still persist and could be argued to apply equally to the adoption of Montgomery. Second, the reasoning in Kohli and Bolam has been reiterated in several recent cases which suggests that despite being aware of the existence of Montgomery, Indian courts are comfortable with the status quo.¹¹⁷ Third, I have hinted earlier that tort litigation in India is sparse and negligence cases are predominantly being dealt with under the Consumer Protection Act as ‘deficiency in service’.¹¹⁸ Therefore, it might be some time before the Supreme Court has the opportunity to lay down a new leading precedent on informed consent in India. This also ties up with the general status of tort law in India as will be discussed next.

Tort law in India

Tort law development has been stunted in India. On problems facing the law of torts in India, Thanvi writes:

The received English law, and more especially law of torts, has not fared well with the Indian conditions of life, and as such it has not been able to sent [sic] its roots deep into the recesses of the Indian soil.¹¹⁹

There is little reliable data to suggest how much tort litigation has occurred as cases in trial courts generally go unreported. Even in the higher courts, only those cases that are marked ‘fit for reporting’ by the judges in the High Courts and the Supreme Court are published.¹²⁰ But from a cursory glance at reported cases, it is evident that litigation under tort law is sparse when compared to other common law jurisdictions. Marc Galanter conducted a 10-year survey (1975–1984) on tort litigation in India and concluded that tort law in India was unsystematic, largely neglected and infrequently resorted to by the people.¹²¹ Noting the poor development of tort law in India, Cassels also remarked that, ‘[a]t least until now the law of tort in India is little more than a myth about how people would be cared for in a better world’.¹²² While the works cited rely on data from decades ago, little seems to have changed to undermine their findings.¹²³ These works were some of the few exhaustive academic commentaries on the status of tort law in India, suggesting, in addition, that not much academic attention has been paid to it.

Nevertheless, a significant portion of the criticism directed against tort law in India is procedural and logistical. There is a long-standing problem of paucity of judges in India,¹²⁴ but more importantly, there is a lack of specialisation among lawyers. As Galanter, based on his years of research conducted on tort law in India, noted ‘[o]ne may visualize Indian lawyers as stuck in a hyper-individualized bazaar economy in which virtually all lawyers offer the same narrow range of services’.¹²⁵ This remark was made three decades ago, but even today, with the advent of many professional and large scale law firms, tort law as a specialisation has not seen much development. Considering that Indian lawyers work with little to no institutional support for specialised knowledge, with no specialist organisation or specialised technical publication in tort law and coupled with the recent trend of constitutionalising private law,¹²⁶ Galanter’s critique from 1986, that tort law in India is unsystematic and largely neglected, still holds. There are also significant barriers to access, such as a lack of legal aid, high court fee and lack of insurance to cover legal fees. These barriers, along with the protracted delays and meagre recoveries, have made people wary of litigation in India.

Despite all these drawbacks, it is nonetheless possible that the courts in India might adopt an innovative application of tort law¹²⁷ if presented with the right opportunity. As Basu fittingly notes:

It seems that the problems of tort law in India lie not so much in the laws themselves as in their use and application. As such they may have much to do with economic and political realities of a more general “underdevelopment” in a Third World nation. After all the number of judges and courts available is really a product of economic necessities and political choices.¹²⁸

Logistical problems aside, there is reason to believe that the Indian courts will forego their current approach to informed consent under tort law and adopt a modern approach to cases dealing with lack of informed consent. The source of this optimism lies in a recent statement pronounced by a two-judge bench of the Supreme Court that said ‘[i]n the times to come, litigation may be based on the theory of lack of informed consent’.¹²⁹

Conclusion

With a booming clinical research industry and large swathes of vulnerable population groups, India needs to move abreast with the legal developments in informed consent in other common law jurisdictions. It is true that individual cases claiming a lack of informed consent in research do not often reach a court of law, and in India’s case, they have not reached the court at all, but this is mostly because there is a legal lacuna that needs to be filled. For now, the Bolam test that the Indian courts have preferred in the treatment context would be inept to deal with the ‘special relationship’ between a researcher and a research subject. Moving forward, courts also need to be erudite about research being a different context than treatment, particularly if they are to build a suitable foundation by which to guide conduct in research.

The legal doctrine of informed consent focuses on the post-fact and post-injury aspect of informed consent, which some might consider trivial given the ethical problems faced by researchers during the informed consent process. But it would be naive to deny the significant effect that law has on the whole process of informed consent. People give and take consent in the shadow of law. For that, the development of clear and concise legal standards is required to tackle grievances arising out of a lack of informed consent in research.

Footnotes

Acknowledgements

I would like to thank Gerard Porter, Lucas Miotto, Anne Griffiths, Morag Goodwin and the anonymous reviewers for their valuable feedback and suggestions.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Himani Bhakuni