Comprehensive Quality Assessment in Clinical Ethics.

Scholars and professional organizations in bioethics describe various approaches to "quality assessment" in clinical ethics. Although much of this work represents significant contributions to the literature, it is not clear that there is a robust and shared understanding of what constitutes "quality" in clinical ethics, what activities should be measured when tracking clinical ethics work, and what metrics should be used when measuring those activities. Further, even the most robust quality assessment efforts to date are idiosyncratic, in that they represent evaluation of single activities or domains of clinical ethics activities, or a range of activities at a single hospital or healthcare system. Countering this trend, iin this article we propose a framework for moving beyond our current ways of understanding clinical ethics quality, toward comprehensive quality assessment. We first describe a way to conceptualize quality assessment as a process of measuring disparate, isolated work activities; then, we describe quality assessment in terms of tracking interconnected work activities holistically, across different levels of assessment. We conclude by inviting future efforts in quality improvement to adopt a comprehensive approach to quality assessment into their improvement practices, and offer recommendations for how the field might move in this direction.

Implications of the Revised Common Rule for Human Participant Research.

This paper looks at the implications of changes to the regulatory governance of human participant research that can be expected with implementation of the Revised Common Rule (RCR). The RCR refers to revisions of the existing federal regulations that govern the performance of research involving human subjects (ie, clinical research) in the United States and, under certain circumstances, when such research is also performed outside the United States. The term "common" is included because it refers to the fact that these regulations, often referred to as Code of Federal Regulations 46, is the common denominator regulations agreed to across a wide swath of federal agencies.

Unaltered ethical standards for individual physicians in the face of drastically reduced resources resulting from an improvised nuclear device event.

When disaster disrupts healthcare and other systems, the ethical allocation of resources should follow principles of justice, defined as fairness, established for normal clinical practice. Standards of clinical practice may be altered during disaster, but ethical standards must remain centered on prioritizing the treatment of patients according to need and the effectiveness of treatment. Should resources become extremely limited, it is fair to restrict their use to patients who have the highest needs, provided that the intervention is effective. When resources become more available, patients with lower priority can be increasingly accommodated.

Resource allocation after a nuclear detonation incident: unaltered standards of ethical decision making.

This article provides practical ethical guidance for clinicians making decisions after a nuclear detonation, in advance of the full establishment of a coordinated response. We argue that the utilitarian maxim of the greatest good for the greatest number, interpreted only as "the most lives saved," needs refinement. We take the philosophical position that utilitarian efficiency should be tempered by the principle of fairness in making decisions about providing lifesaving interventions and palliation. The most practical way to achieve these goals is to mirror the ethical precepts of routine clinical practice, in which 3 factors govern resource allocation: order of presentation, patient's medical need, and effectiveness of an intervention. Although these basic ethical standards do not change, priority is given in a crisis to those at highest need in whom interventions are expected to be effective. If available resources will not be effective in meeting the need, then it is unfair to expend them and they should be allocated to another patient with high need and greater expectation for survival if treated. As shortage becomes critical, thresholds for intervention become more stringent. Although the focus of providers will be on the victims of the event, the needs of patients already receiving care before the detonation also must be considered. Those not allocated intervention must still be provided as much appropriate comfort, assistance, relief of symptoms, and explanations as possible, given the available resources. Reassessment of patients' clinical status and priority for intervention also should be conducted with regularity.