An axiom of medical research ethics is that a protocol is moral only if it has a “favorable risk-benefit ratio”. This axiom is usually interpreted in the following way: a medical research protocol is moral only if it has a positive expected value -- that is, if it is likely to do more good (to both subjects and society) than harm. I argue that, thus interpreted, the axiom has two problems. First, it is unusable, because it requires us to know (...) more about the potential outcomes of research than we ever could. Second, it is false, because it conflicts with the so-called “soft paternalist” principles of liberal democracy. In place of this flawed rule I propose a new way of making risk-benefit assessments, one that does comport with the principles of liberalism. I argue that a protocol is moral only if it would be entered into by competent subjects who are informed about the protocol. The new rule this eschews all pseudo-utilitarian calculation about the protocol’s likely harms and benefits. (shrink)

Today, bioethics experts have an increasing role in public life. However, the question arises: what does bioethics expertise really mean? Can there be such a thing in our globalised world characterised by ethical pluralism? I will argue that bioethics as a discipline represents the transformation of ethics expertise from a hard to a soft form of it. Bioethics was born as a reaction to the growing awareness of ethical pluralism, and it denied the hard form of normative–prescriptive ethics expertise, particularly (...) in its medical ethics form. In contrast, the traditional medical ethics model, and pre-modern societies in general, believed in hard normative ethics expertise. From this followed the characteristic paternalism of traditional medical practice: if physicians were experts in moral matters as well, if they knew what the right course of action to choose was, then they had a right to benevolently force this course of action on their patients. The remnants of this doctrine, although rarely stated explicitly, still can often be seen in clinical practice. The whole bioethics movement can be seen as a radical denial of the doctrine of physician's hard expertise in moral matters. Bioethics, however, represents a type of soft ethics expertise. Hence follows the seeming paradox of bioethics expertise: bioethics is both a denial of ethics expertise as well as a type of ethics expertise. (shrink)

The emergence of controlled, Maastricht Category III, non-heart-beating organ donation programs has the potential to greatly increase the supply of donor solid organs by increasing the number of potential donors. Category III donation involves unconscious and dying intensive care patients whose organs become available for transplant after life-sustaining treatments are withdrawn, usually on grounds of futility. The shortfall in organs from heart-beating organ donation following brain death has prompted a surge of interest in NHBD. In a recent editorial, the British (...) Medical Journal described NHBD as representing “a challenge which the medical profession has to take up.”. (shrink)

Elective ventilation (EV) is ventilation applied, not in the interest of patients, but in order to secure transplantable organs. It carries with it a small risk that patients who would otherwise have died will survive in a persistent vegetative state. Is EV ever justifiable? We argue: (1) The only thing which can justify exposing patients to risk not taken for their benefit is their consent, and we cannot rely on implied consent or third party consent in the case of EV. (...) Thus, absent explicit consent of patients, EV is not justifiable. (2) It is not clear that explicit consent should be sought, or where it is offered honoured, given the potential EV has for deterring organ donors and causing stress to staff and families. (shrink)