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 determine 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. Three broad arguments usually support respect for autonomy.2 One—owed to JS Mill—holds that permitting individuals free choice promotes utility of all, by helping them fulfil ideas of the good, demonstrating ‘experiments in living’. Another draws from Kant’s categorical imperative; its Formula of Humanity holds that the capacity to determine our own values gives us reason to act, and we ought, therefore, to treat others’ values with the respect we show our own. Lastly, many simply assume ‘liberal neutrality’—an intrinsic value in people being permitted to pursue the …. (shrink)

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.1 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’.1 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.1 Smajdor’s approach also offers novel resources to overcome what Giles Birchley characterise as ‘the problems of the binary approach to incapacity’.2 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.3 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. Many …. (shrink)

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).1 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. One dimension along which this is evident is that …. (shrink)

My paper on assent and reification in research involving adults with impairments of capacity and/or communication (AWIC)1 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.2 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.2 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,3 as well as existing protocols and structures that facilitate …. (shrink)

Smajdor’s Reification and Assent in Research Involving Those Who lack Capacity claims, among other things, that ‘adults who cannot give informed consent may nevertheless have the ability to assent and dissent, and that these capacities are morally important in the context of research’.1 More pointedly, she suggests we can rely upon Gillick competence, or that ‘it is worth thinking about why the same trajectory [as children] has not been evident in the context of [adults with impairments of capacity to give (...) informed consent (AWIC)]’.1 I argue that her likening assent in AWIC to assent in children is problematic for at least two related reasons. First, direct comparisons between AWIC and children run the risk of perpetuating or reinforcing infantilising stereotypes against people with disabilities. Second, I argue that people with disabilities are vulnerable in ways that most children are not, and thus, are dissimilar in a morally relevant manner. The infantilising of people with disabilities is quite widely documented and thought to be deeply problematic.2 Not only are people with disabilities often thought to be infantile in regard to particular …. (shrink)

Smajdor argues that “recognition” is the solution to the “reifying attitude” that results from “the urge to protect ‘vulnerable’ people through exclusion from research”. Drawing on theories of reification, we argue that it is the concepts of autonomy and vulnerability themselves that have been reified, resulting in the impoverishment of approaches to autonomy at law and in research ethics. Overcoming such reification demands a deeper consideration of the grounds on which vulnerable individuals are owed recognition and thereby the forms such (...) recognition should take. Smajdor argues for a recognition that appeals to autonomy and that manifests in providing vulnerable individuals with the opportunity to assent. The problem is that this kind of recognition is dependent on a more fundamental kind. It is this second form of recognition that would need to do the heavy lifting for assent-based frameworks to avoid the same problems we find with consent. (shrink)

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 …. (shrink)