Spotlight Articles


In a JAMA Viewpoint The Politics of Informed Consent and the Limits of the First Amendment – Sawiki explores “state-mandated messaging” in consent processes in the U.S. and the role of the courts as patient groups and others challenge such mandates in the courts. The author argues that “courts need to be educated about the ethical principles behind the practice of informed consent” to more competently adjudicate such challenges and that the medical community needs to engage such education, among other responses, to protect related first amendment rights.

Also in the area of legal rights Jowett examines access to and regulation of healthcare for trans youth in Australia, England and Wales in the new book Consent for Medical Treatment of Trans Youth [Cambridge U Press]. Jowett argues that legal barriers to clinical practice should be congruent with and reflect the current state of medical knowledge.

Writing in the Journal of Medical Ethics, Hoffman – Undermining autonomy and consent: the transformative experience of disease – offers interesting perspectives about how transformative  experiences proceeding from disease can challenge a patient’s ability to consent and thereby raise questions about concepts in medical ethics such as patient autonomy.

Finally, in the Canadian Journal of Anesthesia Pope et al. address an area that has received relatively little attention. In Consent for determination of death by neurologic criteria in Canada: an analysis of legal and ethical authorities, and consensus-based working group recommendations the authors discuss whether there should be a requirement to obtain family consent before determination of death by neurologic criteria.

The Politics of Informed Consent and the Limits of the First Amendment
Nadia N. Sawicki
JAMA, 17 April 2023; 329(19) pp 1635-1636
Physicians are accustomed to disclosing the risks and benefits of treatment as part of their ethical and legal duty to secure informed consent. Generally, physicians have the freedom to decide how to communicate this information, and to tailor their disclosures to the needs of individual patients. However, in today’s highly politicized climate, some state legislatures are eliminating this opportunity for professional discretion. Physicians are increasingly being compelled to communicate state-mandated messaging that may be at odds with their professional judgment, violating their ethical duty to secure informed consent by “present[ing] relevant information accurately and sensitively, in keeping with the patient’s preferences for receiving medical information.” Even though physicians and patient advocates have argued that these targeted disclosure laws are unconstitutional, the First Amendment sets few restrictions on the government’s ability to compel physician speech. This Viewpoint discusses the expansion of politically motivated informed consent laws and identifies opportunities for the medical profession to challenge them…

Consent for Medical Treatment of Trans Youth
Steph Jowett
October 2022 [Cambridge University Press]
Book Description
Access to medical treatment for trans youth occupies a haphazard and dynamic legal landscape. In this comprehensive scholarly analysis of the historical and current legal principles, Steph Jowett examines the medico-legal nexus of regulation of this healthcare in Australia and in England and Wales. This is informed by an in-depth discussion of the medical literature on treatment for trans youth, including clinical guidelines, the outcomes of treatment and outcomes for trans youth who are unable to be treated. With illustrative examples and clear language, Jowett argues that legal barriers to clinical practice should be congruent with and reflect the current state of medical knowledge. Not only does Jowett assess the extent to which key legal decisions have been consistent with medical knowledge in the past, but she offers a nuanced, comparative perspective that will inform reform efforts in the future.


Undermining autonomy and consent: the transformative experience of disease
Original Research
Bjørn Hofmann
Journal of Medical Ethics, 3 May 2023
Disease radically changes the life of many people and satisfies formal criteria for being a transformative experience. According to the influential philosophy of Paul, transformative experiences undermine traditional criteria for rational decision-making. Thus, the transformative experience of disease can challenge basic principles and rules in medical ethics, such as patient autonomy and informed consent. This article applies Paul’s theory of transformative experience and its expansion by Carel and Kidd to investigate the implications for medical ethics. It leads to the very uncomfortable conclusion that disease involves transformative experiences in ways that can reduce people’s rational decision-making ability and undermine the basic principle of respect for autonomy and the moral rule of informed consent. While such cases are limited, they are crucial for medical ethics and health policy and deserve more attention and further scrutiny.

Editor’s note: The Paul referred to in this Abstract is philosopher Laurie Ann Paul, and Carel and Kidd are Havi Carel and Ian James Kidd.

Consent for determination of death by neurologic criteria in Canada: an analysis of legal and ethical authorities, and consensus-based working group recommendations
Special Article
Thaddeus M. Pope, Jennifer A. Chandler, Michael Hartwick
Canadian Journal of Anesthesia, 2 May 2023
Open Access
This article addresses the following question: should physicians obtain consent from the patient (through an advance directive) or their surrogate decision-maker to perform the assessments, evaluations, or tests necessary to determine whether death has occurred according to neurologic criteria? While legal bodies have not yet provided a definitive answer, significant legal and ethical authority holds that clinicians are not required to obtain family consent before making a death determination by neurologic criteria. There is a near consensus among available professional guidelines, statutes, and court decisions. Moreover, prevailing practice does not require consent to test for brain death. While arguments for requiring consent have some validity, proponents cannot surmount weightier considerations against imposing a consent requirement. Nevertheless, even though clinicians and hospitals may not be legally required to obtain consent, they should still notify families about their intent to determine death by neurologic criteria and offer temporary reasonable accommodations when feasible. This article was developed with the legal/ethics working group of the project, A Brain-Based Definition of Death and Criteria for its Determination After Arrest of Circulation or Neurologic Function in Canada developed in collaboration with the Canadian Critical Care Society, Canadian Blood Services, and the Canadian Medical Association. The article is meant to provide support and context for this project and is not intended to specifically advise physicians on legal risk, which in any event is likely jurisdiction dependent because of provincial or territorial variation in the laws. The article first reviews and analyzes ethical and legal authorities. It then offers consensus-based recommendations regarding consent for determination of death by neurologic criteria in Canada.

Exploring the Ethical and Moral Implications of Requiring Informed Consent to Determine Death by Neurologic Criteria

Exploring the Ethical and Moral Implications of Requiring Informed Consent to Determine Death by Neurologic Criteria
Matthew J. Hibbs, Morgan C. Arnold, Mark S. Beveridge
Journal of Pain and Symptom Management, May 2023; 65(5)
The American Academy of Pediatrics published guidelines in 1987 providing criteria for the declaration of brain death for children. Multiple societies, including neurology and critical care, renewed these guidelines in 2011 to further standardize the brain-death exam. Despite clear guidelines, laws regarding brain death vary among states, including whether consent is required to perform neurologic testing.
To examine the role of parental consent in brain-death testing from an ethicolegal perspective as well as its potential to create clinician distress.
Case report
Patient is a 3-year-old, previously healthy male who suffered a tragic submersion injury requiring prolonged cardiopulmonary resuscitation. During the subsequent hospitalization, his clinical exam, head CT scan, and electroencephalogram demonstrated devastating, irreversible neurologic injury concerning for brain death. The family refused formal brain-death testing, instead requesting more time to allow for a miraculous recovery. The patient remains on life support after 5 weeks and is beginning to experience multiorgan dysfunction.
Many physicians feel that brain-death testing should not require parental consent. Despite this, states vary in their requirements for parental consent for brain-death testing. When legally permissible, there are competing ethical principles governing a family’s request to delay or refuse brain-death testing.The principle of informed consent reflects the culture change from a paternalistic physician-patient relationship to a collaborative, family-centered approach. However, the argument remains that brain-death testing offers no therapeutic benefit and has the potential to cause harm via apnea testing, thereby requiring informed consent. This case presentation will illustrate the varied legal landscape surrounding pediatric brain-death testing, the ethical principles involved, and the moral injury that can result.

Explanation before Adoption: Supporting Informed Consent for Complex Machine Learning and IoT Health Platforms

Explanation before Adoption: Supporting Informed Consent for Complex Machine Learning and IoT Health Platforms
Research Article
Rachel Eardley, Emma L. Tonkin, Ewan Soubutts, Amid Ayobi, Gregory J. L. Tourte, Rachael Gooberman-Hill, Ian Craddock, Aisling Ann O’Kane
Association for Computing Machinery: Human-Computer Interaction, 16 April 2023
Open Access
Explaining health technology platforms to non-technical members of the public is an important part of the process of informed consent. Complex technology platforms that deal with safety-critical areas are particularly challenging, often operating within private domains (e.g. health services within the home) and used by individuals with various understandings of hardware, software, and algorithmic design. Through two studies, the first an interview and the second an observational study, we questioned how experts (e.g. those who designed, built, and installed a technology platform) supported provision of informed consent by participants. We identify a wide range of tools, techniques, and adaptations used by experts to explain the complex SPHERE sensor-based home health platform, provide implications for the design of tools to aid explanations, suggest opportunities for interactive explanations, present the range of information needed, and indicate future research possibilities in communicating technology platforms.

To Obtain Informed Consent or Not to Obtain Informed Consent? Drones for Health Programs in the Grey Zone between Research and Public Health

To Obtain Informed Consent or Not to Obtain Informed Consent? Drones for Health Programs in the Grey Zone between Research and Public Health
Vyshnave Jeyabalan, Lorie Donelle, Patrick Meier, Elysée Nouvet
Drones 2023, 2 April 2023; 7(4)
Drones are increasingly being introduced to support healthcare delivery around the world. Most Drones for Health projects are currently in the pilot phase, where frontline staff are testing the feasibility of implementing drones into their healthcare system. Many of these projects are happening in remote localities where populations have been historically under-served within national healthcare systems. Currently, there exists limited drone-specific guidance on best practices for engaging individuals in decision-making about drone use in their communities. Towards supporting the development of such guidance, this paper focuses on the issue of obtaining community and individual consent for implementing Drones for Health projects. This paper is based on original qualitative research involving semi-structured interviews (N = 16) with program managers and implementation staff hired to work on health-related projects using drone technologies. In this paper, we introduce a scenario described by one participant to highlight the ethical and practical challenges associated with the implementation and use of drones for health-related purposes. We explore the ethical and practical complexities of obtaining informed consent from individuals who reside in communities where Drones for Health projects are implemented.

Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project

Practical issues in pragmatic trials: the implementation of the Diuretic Comparison Project
Research Article
Ryan E Ferguson, Sarah M Leatherman, Patricia Woods, Cynthia Hau, Robert Lew, William C Cushman, Mary T Brophy, Louis Fiore, Areef Ishani
Society for Clinical Trials, 29 March 2023
The US Department of Veterans Affairs Point of Care Clinical Trial Program conducts studies that utilize informatics infrastructure to integrate clinical trial protocols into routine care delivery. The Diuretic Comparison Project compared hydrochlorothiazide to chlorthalidone in reduction of major cardiovascular events in subjects with hypertension. Here we describe the cultural, technical, regulatory, and logistical challenges and solutions that enabled successful implementation of this large pragmatic comparative effectiveness Point of Care clinical trial.
Patients were recruited from 72 Veterans Affairs Healthcare Systems using centralized processes for subject identification, obtaining informed consent, data collection, safety monitoring, site communication, and endpoint identification with minimal perturbation of the local clinical care ecosystem. Patients continued to be managed exclusively by their clinical care providers without protocol specified study visits, treatment recommendations, or data collection extraneous to routine care. Centralized study processes were operationalized through the application layer of the electronic health record via a data coordinating center staffed by clinical nurses, data scientists, and statisticians without site-based research coordinators. Study data was collected from the Veterans Affairs electronic health record supplemented by Medicare and National Death Index data.
The study exceeded its enrolled goal (13,523 subjects) and followed subjects for the 5-year study duration. The key determinant of program success was collaboration between researchers, regulators, clinicians, and administrative staff at the site level to customize study procedures to align with local clinical practice. This flexibility was enabled by designation of the study as minimal risk and determination that clinical care providers were not engaged in research by the Veterans Affairs Central Institutional Review Board. Cultural, regulatory, technical, and logistical problems were identified and solved through iterative collaboration between clinical and research entities. Paramount among these problems was customization of the Veterans Affairs electronic health record and data systems to accommodate study procedures.
Leveraging clinical care for large-scale clinical trials is feasible but requires a rethinking of traditional clinical trial design (and regulation) to better meet requirements of clinical care ecosystems. Study designs must accommodate site-specific practice variation to reduce the impact on clinical care. A tradeoff thus exists between designing trial processes tailored to expedite local study implementation versus those to produce a more refined response to the research question. The availability of a uniform and flexible electronic health record in the Department of Veterans Affairs played a major role in the success of the trial. Conducting Point of Care research in other healthcare systems without such research-friendly infrastructure presents a more formidable challenge.