Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

ABSTRACTThis report on end‐of‐life decision‐making in Canada was produced by an international expert panel and commissioned by the Royal Society of Canada. It consists of five chapters.Chapter 1 reviews what is known about end‐of‐life care and opinions about assisted dying in Canada.Chapter 2 reviews the legal status quo in Canada with regard to various forms of assisted death.Chapter 3 reviews ethical issues pertaining to assisted death. The analysis is grounded in core values central to Canada's constitutional order.Chapter 4 reviews the (...) experiences had in a number of jurisdictions that have decriminalized or recently reviewed assisted dying in some shape or form.Chapter 5 provides recommendations with regard to the provision of palliative care in Canada, as well as recommendations for reform with respect to the various forms of assisted death covered in this document. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

In Belgium the legal conditions to practise euthanasia are governed by the act on euthanasia of 28 May, 2002 that entered into force on 23 September, 2002. There is no relevant jurisprudence and no guidance is offered by self-regulation made up by the medical profession itself before or after the enactment of the act. Thoughtful comments on the act are, understandably, lacking up to now while the discussions in parliament have been often unclear, contradictory and sometimes even misleading. In other (...) words, the law on euthanasia in Belgium almost coincides with the act on euthanasia.In this respect the situation in the Netherlands is totally different. The law on euthanasia is first of all governed by the "Termination of life on request and assisted suicide act" of 10 April, 2001 that entered into force on 1 April, 2002. This act is generally considered as the codification of the norms and procedures that have governed the practice of euthanasia in the Netherlands for almost three decades. These norms and procedures have largely emerged from within the medical profession itself and were later adopted by the courts in the context of criminal prosecutions. There also exists a very important legal doctrine that offers guidance in understanding this act. In other words, studying the law on euthanasia in the Netherlands is more than merely studying the act on euthanasia. The act is only the ‘tip of the iceberg’.While the Dutch act aims to codify existing practices, the Belgian act mainly aims to modify the behaviour of physicians when ending the life of their patients. It is hoped that a law that pretends to offer legal security to physicians and patients will stimulate patients to express a voluntary and explicit request and that physicians will abandon their practice of ending the lives of patients without their request. Research indeed had pointed out that Belgian physicians frequently 'forget' to obtain the patient’s request before ending his life.Is should be made clear from the outset that a comparison of the Belgian and the Dutch law regulating the practice of euthanasia is a hazardous undertaking. Just comparing both acts — at first sight the Belgian act, although much more detailed, could be considered a 'clone' of the Dutch act — will lead to misleading and even incorrect results. Not only the acts, but also medical practice and legal practice have to be considered when we try to compare the law on euthanasia in both countries. In this article I will make an attempt to do this. Lack of space requires omitting many details from the comparison. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)