The biobank consent debate is one with deeply held convictions on both the ‘broad’ and ‘specific’ side with little sign of resolution. Recently, Thomas Ploug and Soren Holm have developed an alternative to both specific and broad consent: a meta‐consent framework. The aim here is to consider whether meta‐consent provides a ‘solution’ to the biobank consent debate. We clarify what ‘meta‐consent’ actually is (arguing that the label is a misnomer and ‘consent à la carte’ is more accurate). We identify problems (...) with Ploug and Holm's arguments, and some challenges for meta‐consent. We focus on whether there is any ethical obligation to provide consent à la carte. There may seem to be so, especially if we draw upon an unclear appeal to the ethical significance of ‘respect for autonomy’. Similarly, there might seem to be an intuitive inference from the fact that ethically legitimate research requires informed consent to the conclusion that it thereby requires consent à la carte. It is shown that this line of inference is mistaken. (shrink)

This is the third volume of Joel Feinberg's highly regarded The Moral Limits of the Criminal Law, a four-volume series in which Feinberg skillfully addresses a complex question: What kinds of conduct may the state make criminal without infringing on the moral autonomy of individual citizens? In Harm to Self, Feinberg offers insightful commentary into various notions attached to self-inflicted harm, covering such topics as legal paternalism, personal sovereignty and its boundaries, voluntariness and assumptions of risk, consent and its counterfeits, (...) coercive force, incapacity, and choice of death. (shrink)

The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

Self-trust is a necessary condition of personal autonomy and self-respect. Self-trust involves a positive sense of the motivations and competence of the trusted person; a willingness to depend on him or her; and an acceptance of vulnerability. It does not preclude trust in others. A person may be rightly said to have too much self-trust; however core self-trust is essential for functioning as an autonomous human being.

Virtually any appraisal of a person’s welfare, integrity, or moral status, as well as the moral and political theories built on such appraisals, will rely crucially on the presumption that her preferences and values are in some important sense her own. In particular, the nature and value of political freedom is intimately connected with the presupposition that actions one is left free to do flow from desires and values that are truly an expression of the ‘self-government’ of the agent. However, (...) we all know that no person is self-made in the sense of being a fully formed and intact ‘will’ blossoming out of nowhere. Our values and preferences are explained by essential reference to a variety of influences that have come to bear on our development throughout our personal histories. What is needed, then, is to establish an account of self-determination or autonomy that would help determine just when and if the values and preferences we find ourselves with deserve the centrality that moral and political theories place on them. (shrink)

Biobank research is potentially fruitful. It is argued that broad consent is acceptable for future research on biological material because a) the benefit is high, b) it pays respect to people’s autonomy, c) it is consistent with current practices and d) because the risk is low. Furthermore, broad consent should be allowed if information is handled safely, people can withdraw and expanded research should be approved by an ethics review board. However, these arguments are flawed and the criteria for broad (...) consent are either too restrictive to allow any research or fail to address important challenges with biobank research. Broad consent for biobank research can hide substantial ethical challenges and threaten trust in research. This does not mean that biobank research should be abandoned or that people cannot authorise future research on donated biological material. (shrink)

Many accounts of informed consent in medical ethics claim that it is valuable because it supports individual autonomy. Unfortunately there are many distinct conceptions of individual autonomy, and their ethical importance varies. A better reason for taking informed consent seriously is that it provides assurance that patients and others are neither deceived nor coerced. Present debates about the relative importance of generic and specific consent do not address this issue squarely. Consent is a propositional attitude, so intransitive: complete, wholly specific (...) consent is an illusion. Since the point of consent procedures is to limit deception and coercion, they should be designed to give patients and others control over the amount of information they receive and opportunity to rescind consent already given. (shrink)

To be autonomous is to be a law to oneself; autonomous agents are self-governing agents. Most of us want to be autonomous because we want to be accountable for what we do, and because it seems that if we are not the ones calling the shots, then we cannot be accountable. More importantly, perhaps, the value of autonomy is tied to the value of self-integration. We don't want to be alien to, or at war with, ourselves; and it seems that (...) when our intentions are not under our own control, we suffer from self-alienation. What conditions must be satisfied in order to ensure that we govern ourselves when we act? Philosophers have offered a wide range of competing answers to this question. (shrink)

One of liberalism’s core commitments is to safeguarding individuals’ autonomy. And a central aspect of liberal social justice is the commitment to protecting the vulnerable. Taken together, and combined with an understanding of autonomy as an acquired set of capacities to lead one’s own life, these commitments suggest that liberal societies should be especially concerned to address vulnerabilities of individuals regarding the development and maintenance of their autonomy. In this chapter, we develop an account of what it would mean for (...) a society to take seriously the obligation to reduce individuals’ autonomy-related vulnerabilities to an acceptable minimum. In particular, we argue that standard liberal accounts underestimate the scope of this obligation because they fail to appreciate various threats to autonomy. (shrink)

Using the example of an unconsented mouth swab I criticise the view that an action of this kind taken in itself is wrongful in respect of its being a violation of autonomy. This is so much inasmuch as autonomy merits respect only with regard to ‘critical life choices’. I consider the view that such an action is nevertheless harmful or risks serious harm. I also respond to two possible suggestions: that the action is of a kind that violates autonomy; and, (...) that the class of such actions violates autonomy. I suggest that the action is wrongful in as much as it is a bodily trespass. I consider, and criticise, two ways of understanding how morally I stand to my own body: as owner and as sovereign. In respect of the latter I consider Arthur Ripstein's recent defence of a sovereignty principle. Finally I criticise an attempt by Joel Feinberg to explain bodily trespass in terms of personal autonomy. (shrink)

In this article we provide an in-depth description of a new model of informed consent called ‘meta consent’ and consider its practical implementation. We explore justifications for preferring meta consent over alternative models of consent as a solution to the problem of secondary use of health data for research. We finally argue that meta consent strikes an appropriate balance between enabling valuable research and protecting the individual.

Research ethics committees must sometimes deliberate about objects that do not fit nicely into any existing category. This is currently the case with the “gastruloid,” which is a self-assembling blob of cells that resembles a human embryo. The resemblance makes it tempting to group it with other members of that kind, and thus to ask whether gastruloids really are embryos. But fitting an ambiguous object into an existing category with well-worn pathways in research ethics, like the embryo, is only a (...) temporary fix. The bigger problem is that we no longer know what an embryo is. We haven’t had a non-absurd definition of ‘embryo’ for several decades and without a well-defined comparison class, asking whether gastruloids belong to the morally relevant class of things we call embryos is to ask a question without an answer. What’s the alternative? A better approach needs to avoid what I’ll refer to as “the potentiality trap” and, instead, rely on the emergence of morally salient facts about gastruloids and other synthetic embryos. (shrink)

I, for one, am grateful to Peter Ubel, Karen Scherr, and Angela Fagerlin (2017) for their important and illuminating reflections on medical decision making, particularly in the context of preferenc...

Neither the range of potential results from genomic research that might be returned to participants nor future uses of stored data and biospecimens can be fully predicted at the outset of a study. Informed consent procedures require clear explanations about how and by whom decisions are made and what principles and criteria apply. To ensure trustworthy research governance, there is also a need for empirical studies incorporating public input to evaluate and strengthen these processes.

BackgroundInnovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.MethodsAn interdisciplinary workshop jointly organised by the University of Oxford (...) and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.ResultsDynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.ConclusionsDynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures. (shrink)

The High Court continues to exercise its inherent jurisdiction to make declarations about interventions into the lives of situationally vulnerable adults with mental capacity. In light of protective responses of health care providers and the courts to decision-making situations involving capacitous vulnerable adults, this paper has two aims. The first is diagnostic. The second is normative. The first aim is to identify the harms to a capacitous vulnerable adult’s autonomy that arise on the basis of the characterisation of situational vulnerability (...) and autonomy as fundamentally opposed concepts or the failure to adequately acknowledge the conceptual relationship between them at common law. The second part of this aim is to draw upon developments in analytic feminist philosophy to illustrate how standard approaches to autonomy are ill-equipped to capture the autonomy issues of capacitous vulnerable adults when their decisions regarding care and treatment are at stake. The second (normative) aim is to develop an account of self-authorised, intersubjective autonomy on the basis of analytic feminist insights into the relational practices of recognition. This account not only attempts to capture the autonomy of capacitous vulnerable adults and account for the necessary harms to their autonomy that arise from standard common law responses to their situational vulnerability, it is also predicated on the distinctions between mental capacity, the satisfaction of conditions for informed consent and the exercise of autonomy, meaning that it is better placed to fulfil the primary aim of the inherent jurisdiction – to facilitate the autonomy of vulnerable adults with capacity. (shrink)