'Take my kidneys but not my corneas'-Selective preferences as a hidden problem for 'opt-out' organ donation policy.

With aims to both increase organ supply and better reflect individual donation preferences, many nations worldwide have shifted from 'opt-in' to 'opt-out' systems for post-mortem organ donation (PMOD). In such countries, while a prospective donor's willingness to donate their organs/tissues for PMOD was previously ascertained-at least partially-by their having recorded positive donation preferences on an official register prior to death, this willingness is now presumed or inferred-at least partially-from their not having recorded an objection to PMOD-on an official organ donation register. Using evidence regarding the presence and prevalence of selective donation preferences, and via exploration of how appeals to donation preferences are used to both motivate and legitimate shifts to opt-out frameworks, this paper draws attention to a set of previously unexplored problems for opt-out organ donation arising in contexts where: (a) individuals demonstrate selective post-mortem organ/tissue donation preferences, (b) legislation provides prospective donors with the opportunity to selectively permit/refuse the donation of certain organs/tissues in line with these preferences. While selective preferences pose few problems for opt-in systems where a selective occasion is built into the process of signing the donor register, this is not the case for opt-out systems. The loss of this selective occasion can cause significant problems where appeals to preferences motivate/legitimate shifts to opt-out but evidence regarding variable preferences does not feed into determinations regarding organ/tissue exclusions. The nature of these problems depends on how the authorization aspect of 'opt-out' systems is framed (e.g. as presumed consent, deemed consent or, given the role of familial consent in many jurisdictions as consent in name only).

The case against meta-consent: not only do Ploug and Holm not answer it, they make it even stronger.

In a recent article, I argued that Ploug and Holm's 'meta-consent' proposal should be rejected for biobank governance. This was because, although meta-consent is permissible, it is both burdensome and ethically omissible. There is no ethical reason why funders should undertake the additional costs. Ploug and Holm have sought to respond to these arguments. Here, it is noted that not only do they fail to adequately refuse the case against meta-consent, they fail to even engage with the arguments, either misunderstanding them or ignoring them. In their response, Ploug and Holm unwittingly provide the basis of an even stronger case against meta-consent. They argue that broad consent has a built in tendency to expire, while also holding that broad consent should be one of the options available in meta-consent. Meta-consent thus ends up being more like dynamic consent, but, arguably, even more burdensome and costly.

The biobank consent debate: Why 'meta-consent' is not the solution?

Over the past couple of decades, there has been an ongoing, often fierce, debate about the ethics of biobank participation. One central element of that debate has concerned the nature of informed consent, must specific reconsent be gained for each new use, or user, or is broad consent ethically adequate? Recently, Thomas Ploug and Søren Holm have developed an alternative to both specific and broad consent: what they call a meta-consent framework. On a meta-consent framework, participants can choose the type of consent framework they require, for different kinds of use, different types of user and so on. Meta-consent involves a distinctive kind of design of the consent process. Here it is argued, first, that although a meta-consent framework does not wrong participants, Ploug and Holm understate the likely costs and burdens of such a framework, so there are good practical reasons not to offer it. Second, although Ploug and Holm allude to some ethical considerations that might seem to ground an ethical argument for providing meta-consent, they do not offer any sound argument, and it does not wrong participants in any way to fail to offer them the opportunity to design their own consent process.

The ethics of biobanking: Assessing the right to control problem for broad consent.

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.

When is a Choice not a Choice? 'Sham Offers' and the Asymmetry of Adolescent Consent and Refusal.

In some jurisdictions there is a puzzling asymmetry between consent and refusal, where, for some kinds of treatment, the adolescent patient has the power to permit her own treatment but her refusal does not have the same kind of normative significance as refusal of treatment by a competent adult. In this journal I recently offered a clarification and defence of this asymmetry in terms of a paternalistic justification of the sharing of normative powers between adolescents and other parties. Lawlor (2016) offers a number of objections to this account. Three of his objections can be dealt with quickly. But one of them is much more challenging: the asymmetry of consent and refusal entails a practice of making sham offers (offers that purport to be responsive to the patient's choices, but which, in fact, are not). They do not really offer a choice at all. Genuine offers seem to require a commitment to be symmetrically responsive to whatever decision outcome is reached by the recipient of the offer. When we reflect upon the way that offers can be made in complex social contexts, where different parties have a 'say' in what ought to be done, the symmetry of responsiveness need not apply. Offers can be genuine, without being symmetrically responsive. Contrary to the seemingly plausible objection, the asymmetry of consent and refusal does not entail sham offers, or the offer of 'sham choices'.

Misleading by Omission: Rethinking the Obligation to Inform Research Subjects about Funding Sources.

Informed consent requirements for medical research have expanded over the past half-century. The Declaration of Helsinki now includes an explicit positive obligation to inform subjects about funding sources. This is problematic in a number of ways and seems to oblige researchers to disclose information irrelevant to most consent decisions. It is argued here that such a problematic obligation involves an "informational fallacy." The aim in the second part of the paper is to provide a better approach to making sense of how a failure to inform about funding sources wrongs subjects: by making appeals to obligations to refrain from misleading by omission. This alternative approach-grounded in a general obligation to refrain from misleading, an obligation that is independent of informed consent-provides a basis for a norm that protects subjects' interests, without the informational fallacy. The approach developed here avoids the problems identified with the currently specified general obligation to inform about funding sources.

Transitional paternalism: how shared normative powers give rise to the asymmetry of adolescent consent and refusal.

In many jurisdictions, adolescents acquire the right to consent to treatment; but in some cases their refusals - e.g. of life-saving treatment - may not be respected. This asymmetry of adolescent consent and refusal seems puzzling, even incoherent. The aim here is to offer an original explanation, and a justification, of this asymmetry. Rather than trying to explain the asymmetry in terms of a variable standard of competence - where the adolescent is competent to consent to, but not refuse, certain interventions - the account offered here focuses more closely on the normative power to render actions permissible. Where normative powers are shared they can readily give rise to an asymmetry between consent and refusal. We then turn to why it is justifiable that normative powers be shared in adolescence. Transitional paternalism holds that the acquisition of normative powers by competent adolescents should not be an instant one, achieved in a single step, but that there should be a transitional period where paternalistic protection is rolled back, but not entirely withdrawn until a later date. Transitional paternalism could be implemented without generating the asymmetry between consent and refusal but, it is argued, the asymmetric version of transitional paternalism is to be preferred insofar as it offers a greater respect for the adolescent's decisions than the symmetrical alternative.

Why do patients want information if not to take part in decision making?

There is empirical evidence that many patients want information about treatment options even though they do not want to take a full part in decision-making about treatment. Such evidence may have considerable ethical implications but is methodologically problematic. It is argued here that, in fact, it is not at all surprising that patients' informational interests should be separable from (and often stronger than) their interests in decision-making. A number of different reasons for wanting information are offered, some to do with the content of information; some with the process, others with the fact or occasion of informing. This philosophical clarification leads to some suggestions for further empirical study.

What is genetic information, and why is it significant? A contextual, contrastive, approach.

Is genetic information of special ethical significance? Does it require special regulation? There is considerable contemporary debate about this question (the 'genetic exceptionalism' debate). 'Genetic information' is an ambiguous term and, as an aid to avoiding conflation in the genetic exceptionalism debate, a detailed account is given of just how and why 'genetic information' is ambiguous. Whilst ambiguity is a ubiquitous problem of communication, it is suggested that 'genetic information' is ambiguous in a particular way, one that gives rise to the problem of 'significance creep' (i.e., where claims about the significance of certain kinds of genetic information in one context influence our thinking about the significance of other kinds of genetic information in other contexts). A contextual and contrastive methodology is proposed: evaluating the significance of genetic information requires us to be sensitive to the polysemy of 'genetic information' across contexts and then examine the contrast in significance (if any) of genetic, as opposed to nongenetic, information within contexts. This, in turn, suggests that a proper solution to the regulatory question requires us to pay more attention to how and why information, and its acquisition, possession and use, come to be of ethical significance.