SPOTLIGHT ARTICLES

In the May 2023 edition of Informed Consent: A Monthly Review we included the BMJ article by Anna Smajdor just below. Smajdor argues for using assent as a way of recognizing those who are unable to provide consent, which she states “…is a way of responding to [the] moral need for recognition, which exists independently of cognitive capacity…”

Of course, laws, regulation, etc. addressing assent vary widely across the globe [where they exist at all] but typically reference “capacity” in some way. Additionally, such laws/regs often include “maturity” and the assessment of capacity, sometimes identifying who has authority to “determine” capacity.

With regard to assent involving children, Smajdor reminds us “..The importance of respecting children’s views, regardless of legal capacity to give consent, has also been codified elsewhere: Article 12 of the United Nations Convention on the Rights of the Child states that ‘States Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child.’17

There have been a number of responses in the literature to the Smajdor article which we present below. We conclude this section with a follow-up from Smajdor responding to the various commentaries. We would be interested in hearing your perspective, as we may revisit this in a future edition!

Reification and assent in research involving those who lack capacity
Anna Smajdor
BMJ, 26 December 2022
Open Access
Abstract
   In applied ethics, and in medical treatment and research, the question of how we should treat others is a central problem. In this paper, I address the ethical role of assent in research involving human beings who lack capacity. I start by thinking about why consent is ethically important, and consider what happens when consent is not possible. Drawing on the work of the German philosopher Honneth, I discuss the concept of reification—a phenomenon that manifests itself when we fail to observe or respond to our fellow humans’ need for recognition. I suggest that assent is a way of responding to this moral need for recognition, which exists independently of cognitive capacity. I will look at the circumstances in which consent cannot be obtained from human beings, and ask whether some of the same ethically important considerations that underpin the need for consent might be achieved through seeking assent. I discuss the ways in which this might be beneficial for researchers, for prospective research participants and for society at large.
Conclusion
   In this paper, I have shown that the efforts we make to ‘protect’ those who lack capacity in the context of medical research may ultimately contribute to a world in which such people are systematically disadvantaged. The moral frameworks that govern medical research are geared towards ‘reasonable’ people who can give informed consent. Yet, as I have indicated, this is an idealistic vision which bears little resemblance to the day-to-day reality of medical treatment and research. Informed consent has become a perfunctory exercise which neither serves to respect autonomy, nor to dispel the misconceptions that many research participants have. We are too hasty to regard informed consent as the cornerstone of ethical research, and too rigid in our understanding of the relationship between consent, rationality and autonomy. It is undeniable that medical research can be harmful to participants, and that biomedical researchers can be dangerous people. However, if we place effective limits on the powers of researchers to inflict harm on research participants, it is not clear that we have additional grounds to think that those who lack capacity should be excluded from research.
Paying attention to people’s preferences and interests offers a way of engaging with those who lack capacity. Gaining assent, and respecting dissent in these groups offers greater scope for researchers to recognise their needs. In contrast, to exclude such groups by default is to define them solely in terms of their incapacity, and risks entrenching a reifying disposition that creates boundaries between us and them. While there are many legal and ethical complexities involved in medical research with those who lack capacity, there are ways in which the current status quo could be improved. The recognition/reification dichotomy offers a way of conceptualising the relationships that we can have with those who cannot give informed consent.

Call for moral recognition as part of paediatric assent
Commentary
Jared Smith, Jennifer Blumenthal-Barby
Journal of Medical Ethics, 22 June 2023
Excerpt
     In ‘Reification and Assent in Research Involving Those Who Lack Capacity’, Smajdor argues that adults with impaired capacity to grant informed consent (AWIC) are often excluded from participating in biomedical research because they cannot provide informed consent, leading to decreased chances AWIC will benefit from such research. Smajdor uses Honneth’s concept of reification to propose that securing assent (rather than consent) in cases involving AWIC offers patients moral recognition that is not tied to their capacities. Assent provides this recognition by including the patient in a shared moral sphere, highlighting her agency and worth without reducing her to her incapacity or a thing-to-be-managed. Assent also avoids grounding in, or a reliance on, the future development of autonomy (pp.5–6).
Our recent research on patient and caregiver perspectives of potential paediatric deep brain stimulation (pDBS) for refractory obsessive–compulsive disorder (OCD) and dystonia demonstrates that paediatric neurosurgery patients desire the kind of recognition Smajdor associates with assent, and their caregivers largely agree.[2,3] Since (generally) paediatric patients in the USA are unable to grant informed consent, their caregivers must provide it instead. This raises the question of how to properly integrate paediatric patients into the DBS decision-making process.
 

Assent to research by the formerly competent: necessary and sufficient?
Commentary
Hojjat Soofi
Journal of Medical Ethics, 22 June 2023
Excerpt
    Anna Smajdor offers a fresh perspective on why assent is morally required in research practices involving people who (are considered to) lack the capacity to consent. Smajdor holds that seeking (and documenting) assent can be a mechanism to recognise those who (are considered to) lack the capacity to consent as participants ‘in our moral sphere’. Smajdor suggests that this approach can function as a counter to the ‘reifying’ attitudes (often) taken towards people who (are judged to) lack the capacity to consent. Smajdor’s approach also offers novel resources to overcome what Giles Birchley characterise as ‘the problems of the binary approach to incapacity’.
Particularly in the context of dementia research, Smajdor’s proposal can be seen as a promising direction for going beyond the conventional (primarily) ‘protective’ approach taken by research ethics committees. The conventional approach asks researchers to obtain autonomous authorisation from research participants and (at times, implicitly) relies on the assumption that the ability to give consent is the only autonomy-related ability or, in other words, the assumption that the inability to give consent indicates vulnerability due to non-autonomy/non-agency. But this assumption, as Smajdor notes, seems problematic. The ability to assent (or dissent) is also an autonomy-related ability.

Assent: going beyond acknowledgement for fair inclusion
Commentary
Alice Cavolo, Chris Gastmans
Journal of Medical Ethics, 22 June 2023
Excerpt
In her article Reification and assent in research involving those who lack capacity, Anna Smajdor shows how excluding adults with impairments of capacity (AWICs) to protect them from the risks of medical research has the paradoxical effect of harming them by reifying them.1 While the medical risks of excluding vulnerable populations in general from medical research are well known, the main risk being the creation of therapeutic orphans, the risk of reifying these populations is less discussed. Hence, we commend Smajdor for introducing an essential nuance in the debate on inclusion of AWICs in medical research. We also agree with her on the importance of acquiring assent from those who cannot legally consent rather than automatically excluding them from research, as we already do in paediatric research. However, we believe that she fails to acknowledge some practical challenges already observed in paediatric research that hinder the retrieval of assent from AWICs and, consequently, their inclusion in medical research. In this commentary, we will first introduce the main challenge to using assent to include AWICs in research, that is, the fact that individuals might oscillate within the capacity spectrum. We will then provide other examples of practical obstacles to the inclusion of AWICs…

Vulnerable person investigation plan (VIP) to optimise inclusion in clinical trials
Commentary
Ilana C Raburn, Eline M Bunnik, Antonia J Cronin
Journal of Medical Ethics, 22 June 2023
Excerpt
    Smajdor addresses the problem of inferior clinical outcomes among adults with impairments of capacity to give informed consent (AWIC). She notes that AWIC are generally excluded from clinical trials to protect them against harms and avoid exploitation and claims there is a causal link between involvement in clinical trials and favourable outcomes. She argues, given this link, that we should increase AWIC representation in clinical trials and can justifiably do so by recognising the capacity of AWIC to assent.
AWIC form a diverse group, with multiple aetiologias, including, for example, Down syndrome, traumatic brain injury and dementia. In some cases, the inability to consent may fluctuate so that the same person could be AWIC only at certain times. Yet despite these differences, the group has a shared unmet need. We agree with Smajdor that AWIC outcomes should be improved, but question whether simply increasing representation in clinical trials is sufficient to achieve this…

What should recognition entail? Responding to the reification of autonomy and vulnerability in medical research
Commentary
Jonathan Lewis, Soren Holm
Journal of Medical Ethics, 22 June 2023
Excerpt
    Smajdor claims that ‘recognition’ is the solution to the ‘reifying attitude’ that results from ‘the urge to protect “vulnerable” people through exclusion from research’. Specifically, for Smajdor, an assent-based framework—as a means of recognising and respecting the autonomy of vulnerable individuals who would otherwise be excluded from biomedical research—provides such recognition.
If the sole reason for the reification of vulnerable individuals in research contexts is a need to protect them due to their inability to fulfil standards for informed consent, then recognition in the form of assent would, in principle, provide a solution to the reification issue. The central claim of this commentary, however, is that what has been reified are the concepts of autonomy and vulnerability themselves. On that basis, overcoming such reification demands a deeper consideration of the forms that recognition should take if we are to enable vulnerable individuals to make autonomy claims concerning research participation.
Smajdor appeals to Honneth’s account of reification, for which one of starting points is Adorno’s characterisation of reification as ‘identity-thinking’. For Adorno, what identity thinking entails is that concepts ‘are no longer measured against what they contain, and what they contain is no longer measured against concepts; instead, concepts are taken in isolation’. In short, individuals are reduced to concepts such that their ‘particularity’, ‘heterogeneity’ and ‘individuality’ are ignored…

Understanding the autonomy of adults with impaired capacity through dialogue
Commentary
Alistair Wardrope, Simon Bell, Daniel Blackburn, Jon Dickson, Markus Reuber, Traci Walker
Journal of Medical Ethics, 22 June 2023
Excerpt
    Smajdor invites welcome interrogation of the distance between our philosophical justifications of how we engage people in decisions about healthcare or research, and the ways we do so.1 She notes the implicit elision made between autonomy and informed consent, and argues the latter alone cannot secure the former, proposing a more flexible approach.
As researchers working with people with dementia (PwD), we share Smajdor’s reservations. We argue that an autonomy worthy of respect requires not just decision-making capacity, but also authenticity; the ability to deter  mine for oneself what is good for oneself.2 Furthermore, our relationships support or undermine both capacity and authenticity, and autonomous expression manifests throughout evolving relationships. This invites us to view respect differently—as an ongoing conversation with another person, capable of holding values that may move us. In Smajdor’s terminology, it requires that we recognise them. We describe how we operationalise this in our research…

Assent and reification: a response to the commentators
Commentary
Anna Smajdor
Journal of Medical Ethics, 22 June 2023
Excerpt
    My paper on assent and reification in research involving adults with impairments of capacity and/or communication (AWIC) drew many thoughtful and insightful responses. I am grateful to all who submitted commentaries.
Most agreed in principle that AWIC could be better represented in medical research. However, several commentators felt that further clarification was needed in terms of what assent is and how it should be obtained and operationalised. I fully agree that if increased representation of AWIC is to come about through an assent-based approach, further clarificatory work is needed, and am glad to think my paper may function as a stimulus for this.
Some commentators worry that an assent-based approach will impose heavy demands on researchers and entail higher costs. I acknowledge this, but would argue that if better inclusion of AWIC is a worthwhile goal, we should be willing to accept some costs. The move from an exclusionary to an inclusive approach will become less demanding once it is accepted as the default. And as I argue in my paper, we have resources on which to draw, including materials designed to facilitate comprehension and communication with AWIC that have been developed in other spheres, as well as existing protocols and structures that facilitate…

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
Viewpoint
Nadia N. Sawicki
JAMA, 17 April 2023; 329(19) pp 1635-1636
Excerpt
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
Book
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
Abstract
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
Abstract
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.