Introduction to special issue: risk and probability in bioethics

Abstract

Although thoughtful people have long pondered the uses and abuses of medical procedures, the character and importance of health and disease and the allocation of scare life-saving resources, the examination of these issues under the rubric of ‘bioethics’ is less than 50 years old. The emergence of a distinct field resulted from a confluence of several concerns. These included recurring disclosures about the harmful and deceptive treatment of human subjects in biomedical research; anxiety over the accelerating growth and uncritical embrace of biotechnologies for creating, enhancing and prolonging lives; and a strong ambivalence about the increasing use of cost–benefit analysis and other economic techniques to ‘rationalize’ medical decision making. Bioethicists have never shown the reflex aversion to numerical probability and statistics found in many areas of law. At the same time, bioethics was borne of wariness about scientific progress and economic rationalization; the field was galvanized not only by the widespread abuse of science and medicine but also by the arrogance and overconfidence of scientists and physicians concerning the superiority of their methods. Moreover, there was resistance within the practices encompassed by bioethics to various forms of quantification: from practicing physicians, who prized their clinical judgement over evidence-based medicine, with its statistical techniques for diagnosis and treatment, and from health policy makers and advocates who rejected cost–benefit and cost-effectiveness analysis as decision-making techniques, doubting that they could capture values critical to ‘tragic choices’ among competing medical needs. In creating this special issue, we sought contributions from writers who had addressed probability and risk in different areas of bioethical interest—in research ethics, where concerns about risks to human subjects have played a central role, in clinical medicine, where the resistance to quantitative approaches has traditionally been strongest, and in health and science policy, home to protracted debates about the appropriate procedures and metrics for decision making. Our contributors all address issues of risk in these areas, issues that are in most cases closely tied to the legal or administrative regulation of research and clinical practice and the shaping of public policy. Each of these essays challenges standard views about how risk should be assessed, compared or managed by public policy. Wendler and Rid review several of the leading approaches to assessing risks in research on human subjects, including approaches that impose different standards for therapeutic and nontherapeutic research or for research undertaken with different purposes. They favour