Of Principles and P Values

Abstract

Empirical and conceptual work in bioethics often focuses on issues relating to what might be termed the consensus tenets of bioethics, namely, a collection of foundational principles (e.g., autonomy, beneficence, and justice) and related concepts (e.g., informed consent, shared decision-making, and institutional review boards [IRBs]). The successful uptake of these principles is demonstrated by their prominence in the academic research literature, domestic and international guidelines, policy and regulations, and even the popular discourse. Informed consent is regarded as a nearly indispensable requirement of ethical [clinical] practice or research, and health care professionals are expected to actively engage patients or their surrogates in the process of shared decision making. Researchers and health care professionals must protect the interests of research participants and patients. Government regulatory agencies generally require independent ethical review of research involving human subjects. Thus, despite the diverse array of disciplines constituting the field of bioethics, those working in the field share a general framework and vocabulary with which to analyze and respond to difficult ethical issues. That the concept of informed consent, for example, is understood and accepted across a wide range of professional and lay communities has resulted in the development of a large body of evidence that has improved biomedical policies and practices. A simple but powerful example is the use of various types of visual aids and alternative media to improve the informed consent process in populations with low literacy rates or unfamiliarity with basic scientific concepts (Woodsong and Karim 2005). Even when research and analysis is intended to challenge the status, role, or interpretation of core values and principles, recognition and understanding of them provide an important starting place. The consensus tenets can be understood as the background assumptions of empirical and conceptual work in bioethics, and, like any background assumptions, they should be the subjects of ongoing critical inquiry. Although earlier discussions emphasized the purported differences between “Western” and “Asian” (or in some cases “European”) approaches to bioethics, evidential and normative support for these positions has weakened (Macklin 1999). Instead of trying to sharpen into absolutes