Joseph DeMarco

Some bioethicists have argued in favor of a sliding scale notion of competence, paternalistically requiring greater competence in relation to more significant risk. I argue against a sliding scale notion, taking issue with the positions of Allen E. Buchanan and Dan W. Brock, Ian Wilkes, and Joel Feinberg. Rejecting arguments that a sliding scale is supported by legal cases, by ordinary usage, and by fallible judgments about competence, I argue in favor of greater evidence of competence when risk is greater. Two clinical cases are examined, both involving amputation, to show that my fixed concept of competence, with a requirement of clearer evidence of competence when risk is high, better accounts for good moral decisions in bioethics.

_Bioethics: Legal and Clinical Case Studies_ is a case-based introduction to ethical issues in health care. Through seventy-eight compelling scenarios, the authors demonstrate the practical importance of ethics, showing how the concerns at issue bear on the lives of patients, health-care providers, and others. Many central topics are covered, including informed consent, medical futility, reproductive ethics, privacy, cultural competence, and clinical trials. Each chapter includes a selection of important legal cases as well as clinical case studies for critical analysis. The case studies are often presented as moral dilemmas and are conducive to rich discussion. A companion website offers a curated collection of relevant legal precedents along with additional case studies and other resources.

Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document did not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists.

Approaches to clinical ethics dilemmas that rely on basic principles or rules are difficult to apply because of vagueness and conflict among basic values. In response, casuistry rejects the use of basic values, and specification produces a large set of specified rules that are presumably easily applicable. Balancing is a method employed to weigh the relative importance of different and conflicting values in application. We argue against casuistry and specification, claiming that balancing is superior partly because it most clearly exhibits the reasoning behind moral decision-making. Hence, balancing may be most effective in teaching bioethics to medical professionals.