Joseph DeMarco

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.

Do the conditions under which promises are made determine whether they ought to be kept? Philosophers have placed a number of conditions on promising which, they hold, must be met in order to make promise‐keeping obligatory. In so doing, they have distinguished valid promises from invalid promises and justified promises from promises that are not justified. Considering such conditions, one by one, we argue that they are mistaken. In the first place, the conditions they lay down are not necessary for either valid or justified promise‐making. In the second place, promises need not meet such conditions in order to create moral obligations. In general, such analyses of promising fail because they suffer from a confusion between promise‐making and promise‐keeping. Philosophers have wrongly supposed that obligations to keep promises are dependent upon, or derivable from, the quality of the promises themselves, at the time they are made, instead of focusing on conditions that must be satisfied at the time when promises are supposed to be kept. It is not the quality of a promise that determines an obligation to keep it but the rightness or wrongness of performing the promised act.