We regularly wield powers that, upon close scrutiny, appear remarkably magical. By sheer exercise of will, we bring into existence things that have never existed before. With but a nod, we effect the disappearance of things that have long served as barriers to the actions of others. And, by mere resolve, we generate things that pose significant obstacles to others' exercise of liberty. What is the nature of these things that we create and destroy by our mere decision to do (...) so? The answer: the rights and obligations of others. And by what seemingly magical means do we alter these rights and obligations? By making promises and issuing or revoking consent When we make promises, we generate obligations for ourselves, and when we give consent, we create rights for others. Since the rights and obligations that are affected by means of promising and consenting largely define the boundaries of permissible action, our exercise of these seemingly magical powers can significantly affect the lives and liberties of others. (shrink)

This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, (...) if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly. (shrink)

Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified.

Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which (...) other obligations, prohibitions, and rights can be waived or set aside in controlled and specific ways. Their book offers a coherent, wide-ranging and practical account of the role of consent in biomedicine which will be valuable to readers working in a range of areas in bioethics, medicine and law. (shrink)

John Searle began to discuss his recently published book `The Construction of Social Reality' with Anthony Freeman, and they ended up talking about God. The book itself and part of their conversation are introduced and briefly reflected upon by Anthony Freeman. Many familiar social facts -- like money and marriage and monarchy -- are only facts by human agreement. They exist only because we believe them to exist. That is the thesis, at once startling yet obvious, that philosopher John Searle (...) explores in The Construction of Social Reality. (shrink)

This is a formal and systematic study of the logical foundations of speech act theory. The study of speech acts has been a flourishing branch of the philosophy of language and linguistics over the last two decades, and John Searle has of course himself made some of the most notable contributions to that study in the sequence of books Speech Acts, Expression and Meaning and Intentionality. In collaboration with Daniel Vanderveken he now presents the first formalised logic of a general (...) theory of speech acts, dealing with such things as the nature of an illocutionary force, the logical form of its components, and the conditions of success of elementary illocutionary acts. The central chapters present a systematic exposition of the axioms and general laws of illocutionary logic. (shrink)

I begin my analysis of consent by agreeing with Professor Hurd that consent functions as a “moral transformative” by altering the obligations and permissions that determine the Tightness of others' actions. I further agree with her that consent is intimately related to the capacity for autonomous action; one who cannot alter others' obligations through consent is not fully autonomous. I cannot improve on her elaboration of these points.

Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant bearing (...) on the interests of family members who have not consented to the study. This casts doubt on the adequacy of consent for such studies. This book also questions the assumptions that informed consent is essential and that it satisfactorily protects the principle of individual autonomy. It reviews recent empirical studies that challenge the possibility of truly informed consent and highlights the extent to which consent is governed by social norms and expectations. It also investigates how consent might be of secondary importance in some circumstances, for example when a research project appears to protect a public or community interest. (shrink)

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted (...) to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests. (shrink)