Equipoise and the Duty of Care in Clinical Research: A Philosophical Response to Our Critics

Abstract

Franklin G. Miller and colleagues have stimulated renewed interest in research ethics through their work criticizing clinical equipoise. Over three years and some twenty articles, they have also worked to articulate a positive alternative view on norms governing the conduct of clinical research. Shared presuppositions underlie the positive and critical dimensions of Miller and colleagues' work. However, recognizing that constructive contributions to the field ought to enjoy priority, we presently scrutinize the constructive dimension of their work. We argue that it is wanting in several respects.

Keywords:

• duty of care
• equipoise
• harm-benefit evaluation

ACKNOWLEDGMENTS

Paul B. Miller's research is supported by a doctoral fellowship from the Social Sciences and Humanities Research Council of Canada. Charles Weijer's research is supported by a Tier I Canada Research Chair and a Canadian Institutes of Health Research operating grant.

Notes

1. F.G. Miller and colleagues never expressly consider whether the requirement applies equally to individual physician-researchers and IRBs, and if so, whether it should be specified distinctly for each. The authors seem merely to presume that the requirement applies equally to IRBs and individual physician-researchers, and that it is to be identically specified for each. Because F.G. Miller and colleagues vacillate in referring to IRBs and individual physician-researchers when discussing the requirement, our analysis will at times reflect that vacillation.

2. For example, we are working on specification of the requirement that the risks of non-therapeutic procedures be deemed reasonable in relation to the value of the knowledge to be gained from the study, and we are contemplating whether to add a threshold limiting the risks of non-therapeutic procedures for research involving competent adults.

3. Note that the reasonableness requirement is actually one of three risk-related requirements. The other two include the minimal risk threshold, and the requirement that risks be minimized consistent with sound scientific design. The distinct nature of these requirements is obscured by the general label “favorable risk-benefit ratio” in the seven-point framework.

4. Note, however, that in contrast to component analysis, key terms such as “experimental interventions” and “research procedures” are left undefined (see Miller & Silverman, 2004, p. 564).

5. Which is not to say exclusively or inordinately self-interested.