Bell v Tavistock: Rethinking informed decision-making as the practical device of consent for medical treatment
Abeezar I. Sarela
Clinical Ethics, 27 December 2021
The decision of the High Court in Bell v Tavistock has excited considerable discussion about lawful consent for puberty-blocking drug treatment for children with gender dysphoria. The present paper draws attention to a wider question that surfaces through this case: is informed decision-making an adequate practical tool for seeking and obtaining patients’ consent for medical treatment? Informed decision-making engages the premises of the rational choice theory: that people will have well-crystallised health goals; and, if they are provided with sufficient information about medical treatments, then they will be able to choose the treatment that satisfies their goals. Whilst appealing, the informed decision-making paradigm is assailed by various fallacies, which apply not only to children but also to adults. In Bell v Tavistock, the High Court seems to have recognised such fallacies, and it rejected informed decision-making as an adequate tool for consent from children with gender dysphoria. Similar considerations apply to adults in various situations. Thus, Bell v Tavistock can be seen as an attempt to refine the views on the consent that were expressed by the Supreme Court in Montgomery. It can be inferred that the Supreme Court did recognise the limitations of informed decision-making, but it did not develop this point. Further work is required to formulate an adequate model of decision-making, and Bell v Tavistock serves as a useful reminder to rethink informed decision-making as the device for consent.
Understanding the legal considerations of consent in nursing practice
Nursing Standard, 22 November 2021
Consent to treatment is a common, albeit complex, aspect of nursing practice. Over the past few years, laws have been strengthened to provide increased recognition of patient autonomy. This has meant that there is a greater onus placed on nurses to understand how consent is obtained from patients, the elements required to ensure any consent is valid, and how to proceed when it has been determined that a patient does not have the mental capacity to consent to treatment. This article explores some of the legal considerations that nurses should keep in mind when seeking consent from a patient.
Obtaining informed consent from patients hospitalized in the surgical wards as a major legal challenge
Seyed Khosro Ghasempouri, Masoud Shayesteh Azar, Mohammad Hosein Kariminasab, Zakaria Zakariaei, Mohammad Khademloo, Hesamoddin Raeeis Danaei, Ashkan Zakariaei
Annals of Medicine and Surgery, 17 November 2021
Background and objectives
Informed consent (IC) is the process of establishing communication between the physician and the patient or an alternative decision that leads to the agreement or rejection of the patient and/or their legal representative to perform specific medical procedures. In this study, we evaluated the level of awareness and patient participation in IC in the surgical wards of the general hospital in northern Iran in the 2019–2020 years.
Patients and methods
This study is cross-sectional research that was performed during the 2019–2020 years. The statistical population includes patients admitted to the surgical wards of the general hospital in northern Iran in 2019–2020. The Cochran’s formula was used to determine the sample size and the statistical sample size was 385 patients. The sampling method is stratified random. The method of data collection was through questionnaire tools. The software used was SPSS 21 with an independent t-test and one-way ANOVA.
Our data showed that the frequency of men was significantly higher (P < 0.001). Individuals with a higher education group have a significantly higher level of awareness (P < 0.001). The Pearson’s Correlation (PC) test showed that there was no significant correlation between age and patients’ awareness score (PC = -0.007, P = 0.887).
The current study showed that individuals with higher education had a significantly higher level of awareness, and there was no significant correlation between age and patients’ awareness score. Therefore, senior university administrators are suggested to improve IC processes in accordance with the patients’ rights charter and internationally accredited standards, and assist health care providers with legal implications in the courts.
Informed consent: Legalities, perspectives of physicians and patients, and practices in OECD/non-OECD countries
Amrita Shenoy, Gopinath N. Shenoy, Gayatri G. Shenoy
Médecine Palliative, 30 October 2021
In the medico-legal context, obtaining informed consent is described as the process in which the doctor apraises the patient of the intricacies of the proposed treatment, its alternatives, benefits and risks presented, therein, the right to refuse or withdraw consent at any point, and the risks of not undergoing treatment at all. As segments of disciplined inquiry, we, hereby, present a synthesis of the legalities, perspectives of physicians and patients, and practices in two cohorts of countries. We, specifically, analyze the above segments in the context of formative informed consent codes prevalent in France, United States, United Kingdom, Brazil, and India. In this process, we place focus on landmark judgments that conceived the frameworks of informed consent to its present stage. The present study, additionally, elaborates on the past practice of modulating the volume/intensity of medical details conveyed to the patient or, in other words, how informed the informed consent should be. We illustrate the above concept with an example of the once conservative English medical approach that has now shifted to a collaborative American one. An eminent Scottish judgment ruled in 2017 was instrumental in enacting the same. Conclusively, we explore how illiterate or semi-literate, financially constrained patients are withdrawn and passive in medical decision-making. The process of obtaining informed consent from the above stratum of poverty-stricken fiscally restrained patients is known to be potentially cumbersome. In this context, we, nevertheless, propose to expand on the ways of obtaining informed consent contextual to the above patient qualities.
Should we criminalize a deliberate failure to obtain properly informed consent?
Clark Hobson, José Miola
Medical Law International, 25 October 2021
This paper takes the form of a polemic and thought experiment. The starting point is that, if medical law’s claims to place autonomy at the heart of the enterprise are to be taken seriously, then autonomy either needs to be considered a recoverable harm, or the most egregious infringements should be subject to the criminal law. This might particularly be the case where a doctor deliberately attempts to modify the patient’s decision by failing to disclose information that they know that the patient would find significant. The article considers medical law’s relationship with autonomy, before applying the criminal law – in the form of the analogous situation of defendants who deliberately fail to disclose HIV+status to their sexual partners. What we find is a distinct difference in the way that autonomy is seen by medical and criminal law, although both are equally unsatisfactory.
“I Agree to Disagree”: Comparative Ethical and Legal Analysis of Big Data and Genomics for Privacy, Consent, and Ownership
Seema Belani, Georgina C. Tiarks, Neil Mookerjee, Vijay Rajput
Cureus, 13 October 2021
Statement of Purpose
Digital healthcare, as it relates to big data and genomics, presents a real threat to privacy and ownership rights for individuals and society.
Our experience with genomics provides a lens to facilitate the way we navigate toward a future health data space. Contemporary and innovative legal and ethical models can be applied to concepts of privacy, ownership, and consent in relation to big data.
Technological innovation has transformed healthcare at a faster rate than legal reform, security measures, and consent policies can adapt. The Health Information Portability and Accountability Act (HIPAA) has been recognized as a work in progress, with respect to big data as it relates to healthcare and individual wellbeing. The shortcomings of HIPAA, and its application to big data, can be paralleled with its prior limitations surrounding genomics in the last two decades. The Genetic Information and Nondiscrimination Act (2008) and Genomic Data Sharing Policy (2015) were established to overcome HIPAA’s inadequacies concerning genetic discrimination and security. These policies can serve as a basic model for our approach to legislative reform as it relates to privacy risks with big data generated in healthcare and from healthy individuals in society who are not patients. In addition to notions of privacy, concepts of ownership and consent have become increasingly vague and opaque. The technological advancements have facilitated access and transmission of information, such that big data can be sold for financial gain for commercial enterprise. This applies to genomics, with companies like 23andMe, in addition to big data, as it relates to big tech giants like Apple or Google who oversee wearable and search term data. Clarity of ownership within a digital healthcare arena needs to be defined through ethical and legal frameworks at a global level.
A narrative review of the literature published between 2010 and 2021 was performed using PubMed and Google Scholar. Articles discussing privacy, security, ownership, big data, and genomics were included as relevant literature.
As a society, we are at a crossroads; we must determine the extent of privacy that we are willing to give for science and society. We cannot continue with the current status quo in hope that individual will be used for the greater good of society. We need to strive for a cohesive approach to combat privacy violations by encouraging legislative reform, ethical accountability, and individual responsibility.
Learning from informed consent litigation to improve practices: A systematic review
Karine Giudici-Wach, Pierre Gillois, Thomas Remen, Frédérique Claudot
Patient Education and Counseling, 8 October 2021
To describe the reasons that lead judges to qualify malpractice as a lack of information, then rule in favour or not of the health professional (HP).
We conducted a systematic review of case law relating to the breach of disclosure obligations over a ten-year period from 2010 to 2020. We used 3 legal databases: Légifrance, Dalloz and Lexis 360, all identified as the most exhaustive.
Of the 514 law cases included: judges found malpractice owing to lack of information in 377 (73.3%) cases. Among the latter, malpractices were lack of risk information (N = 257, 68.2%), lack of proof of information (N = 243, 64.5%) and/or lack of information on therapeutic alternatives (N = 49, 13.0%). These malpractices resulted in a conviction of the HP in 268 (71.1%) of the cases.
Case law is an important source of information for improving the quality of HP, lawyers, and judges’ practices.
The Informed Consent Doctrine in Legal Malpractice Law
Vincent R. Johnson
St. Mary’s Journal on Legal Malpractice & Ethics, 6 October 2021; 11(2)
The doctrine of informed consent is now deeply embedded into the law of legal ethics. In legal malpractice litigation, the doctrine holds that a lawyer has a duty to disclose to a client material information about the risks and alternatives associated with a course of action. A lawyer who fails to make such required disclosures and fails to obtain informed consent is negligent, regardless of whether the lawyer otherwise exercises care in representing a client. If such negligent nondisclosures cause damages, the lawyer can be held accountable for the client’s losses. Shifting the focus of a legal malpractice action from garden-variety negligence (such as ignorance of the law, late filing of a complaint, or failure to safeguard client funds or data) to a lack of informed consent can potentially transform a losing case into a winner. Among other things, the doctrine has the potential to simplify and clarify the plaintiff’s argument, which may be especially useful if the case is tried to a jury. The informed consent doctrine also makes sense as a matter of public policy, because clients have a right to control important matters related to their representation. This Article explores the informed consent doctrine in legal malpractice law. It discusses the rise of the informed consent doctrine in medical malpractice law and traces the transplantation of the language and principles of informed consent, first, into the law of lawyer discipline, and then into the law of lawyer civil liability. The Article explores what the relevant legal malpractice case law says about the obligation to obtain informed consent. Finally, the Article addresses certain pivotal issues in the operation of the informed consent doctrine in claims by clients against lawyers, including the nature of lawyer disclosure obligations, the limits imposed by the scope of the representation, the role of expert testimony, and the standard for proving factual causation.
Risk Management for a Legally Valid Informed Consent
Guerra F, La Rosa P, Guerra F, Raimondi L, Marinozzi S, Miatto I, Vergati D, Ndokaj A, Gasperini N, Corridore D, Nardi GM, Mazur M, La Torre G, Ottolenghi L
La Clinica Terapeutica, 1 September 2021; 172(5) pp 484-488
Gelli-Bianco law (Law no. 24/2017) [Italy] intervenes both in order to divide healthcare liability between the healthcare professional and the facility in which he/she exercises and to incentivize the latter to adopt an organizational model suitable for managing the risk associated with the provision of any healthcare service, including the information for consent. In fact, the healthcare facility must guarantee clear, complete and adequate information on the specific case, which, therefore, cannot consist of standard forms to be signed by the patient, under penalty of a flawed consent to treatment and consequent healthcare liability in the event of an adverse event. The regulation mandates that safety must be guaranteed through proper prevention tools and health care risk management, in conjunction with the most effective use of structural, technological and organizational resources available. It further spells out the obligation of health care professionals to contribute to risk prevention while administering health care procedures. For this reason, the consent information constitutes a source of risk for the responsibility of the healthcare provider and the Facility and it must necessarily be managed. Risk Management is the management tool that can allow the healthcare facility to improve the quality and safety of the services provided, optimizing the risk of adverse events through proper monitoring of the same. This paper will be published, following a special agreement, on the two journals “Igiene e Sanità Pubblica” and “La Clinica Terapeutica”, in Italian and in English, in order to increase the diffusion to a wider audience.
Must Consent Be Informed? Patient rights, state authority, and the moral basis of the physician’s duties of disclosure
Kennedy Institute of Ethics Journal, September 2021; 31(3) pp 247-270
Legal standards of disclosure in a variety of jurisdictions require physicians to inform patients about the likely consequences of treatment, as a condition for obtaining the patient’s consent. Such a duty to inform is special insofar as extensive disclosure of risks and potential benefits is not usually a condition for obtaining consent in non-medical transactions.
What could morally justify the physician’s special legal duty to inform? I argue that existing justifications have tried but failed to ground such special duties directly in basic and general rights, such as autonomy rights. As an alternative to such direct justifications, I develop an indirect justification of physicians’ special duties from an argument in Kant’s political philosophy. Kant argues that pre-legal rights to freedom are the source of a duty to form a state. The state has the authority to conclusively determine what counts as “consent” in various kinds of transactions. The Kantian account can subsequently indirectly justify at least one legal standard imposing a duty to inform, the reasonable person standard, but rules out one interpretation of a competitor, the subjective standard.