This paper challenges the traditional assumption that descriptive and prescriptive sciences are essentially distinct by presenting a study on the implicit normativity of the production and presentation of biomedical scientific facts within evidence-based medicine. This interdisciplinary study serves as an illustration of the potential worth of the concept of implicit normativity for bioethics in general and for integrated empirical ethics research in particular. It demonstrates how both the production and presentation of scientific information in an evidence-based decision-support contain implicit presuppositions (...) and values, which pre-structure the moral environment of the clinical process of decision-making. As a consequence, the evidence-based decision support did not only support the clinical decision-making process; it also transformed it in a morally significant way. This phenomenon undermines the assumption within much of the literature on patient autonomy that information disclosure is a conditional requirement before patient autonomy even starts; patient autonomy is already influenced during the production and presentation of information. These results imply an increased responsibility of those who produce and present evidence-based facts(i.e. scientists in general and physicians in particular). The insights of this study not only involve a different focus on both theory and practice of patient autonomy and informed consent, but they also call for a broader scope of morality than does traditional empirical research in bioethics. The concept of implicit normativity within integrated empirical ethics research calls for a strong cooperation between bioethicists and descriptive scientists, i.e., a cooperation that goes beyond the discipline-specific epistemic values and that takes place during all phases of the research process. (shrink)

Eight research protocols which had previously been approved by Ethical Research Committees (ERCs) were reviewed in simulated review committees set up during a symposium on medical ethics. Only three protocols were considered to provide fully adequate information to allow ethical review and only one protocol was thought to provide sufficient guarantees on the ethical issues raised by the proposed research. For five other protocols additional safeguards were considered necessary, in particular covering the problem of informed consent. Two protocols were considered (...) to raise unresolvable ethical issues. This artificial exercise does not establish that review by ERCs is ineffective. It does highlight the lack of objective criteria in ethical review. Peer review by exchange of protocols between ERCs could assist in increasing the consistency in the application of ethical standards. (shrink)

Informed consent is increasingly heralded as an ethical panacea, a tool to counter autocratic and paternalistic medical practices. Debate about the implementation of informed consent is constricted and polarised, centring on the right of individuals to be fully informed and to freely choose versus an autocratic, paternalistic practice that negates individual choice. A bioethical framework, based on a principle-led form of reductive/deductive reasoning, dominates the current model of informed consent. Such a model tends to abstract the process of consent from (...) its clinical and social setting. By fleshing out the social process involved when patients and healthy volunteer subjects consent to take part in clinical drug trials, this paper attempts to address the problem arising from the current ‘empty ethics’ model. My arguments are substantiated by qualitative interview data drawn from a study I conducted on the process of consent as experienced by participants in clinical drug trials. (shrink)

Current approaches in bioethics largely overlook the multicultural social environment within which most contemporary ethical issues unfold. For example, principlists argue that the common morality of society supports four basic ethical principles. These principles, and the common morality more generally, are supposed to be a matter of shared common sense. Defenders of case-based approaches to moral reasoning similarly assume that moral reasoning proceeds on the basis of common moral intuitions. Both of these approaches fail to recognize the existence of multiple (...) cultural and religious traditions in contemporary multicultural societies. In multicultural settings, patients and their families bring many different cultural models of morality, health, illness, healing, and kinship to clinical encounters. Religious convictions and cultural norms play significant roles in the framing of moral issues. At present, mainstream bioethics fails to attend to the particular moral worlds of patients and their family members. A more anthropologically informed understanding of the ethical issues that emerge within health care facilities will need to better recognize the role of culture and religion in shaping modes of moral deliberation. (shrink)