Open disclosure of adverse events: transparency and safety in health care.

Many patients suffering adverse events in health care turn to the legal system to learn what happened to them and to seek compensation. Health care providers have ethical, professional, and legal duties to disclose the harmful effects of care to the patient, regardless of how small the risk. The purpose of open disclosure is to explain what happened to the patient and to seek a just outcome for patient and provider. This article explores our experience of managing and implementing an open disclosure program in an acute and chronic tertiary care facility with university affiliation in the Veterans Health Administration.

Who pays for providing spiritual care in healthcare settings? The ethical dilemma of taxpayers funding holistic healthcare and the first amendment requirement for separation of church and state.

All US governmental, public, and private healthcare facilities and their staff fall under some form of regulatory requirement to provide opportunities for spiritual health assessment and care as a component of holistic healthcare. As often the case with regulations, these facilities face the predicament of funding un-reimbursable care. However, chaplains and nurses who provide most patient spiritual care are paid using funds the facility obtains from patients, private, and public sources. Furthermore, Veteran healthcare services, under the United States Department of Veterans Affairs (VA), are provided with taxpayer funds from local, state, and federal governments. With the recent legal action by the Freedom From Religion Foundation, Inc. (FFRF) against the Veterans Administration, the ethical dilemma surfaces between taxpayers funding holistic healthcare and the first amendment requirement for separation of church and state.

Ethical challenges within Veterans Administration healthcare facilities: perspectives of managers, clinicians, patients, and ethics committee chairpersons.

To promote ethical practices, healthcare managers must understand the ethical challenges encountered by key stakeholders. To characterize ethical challenges in Veterans Administration (VA) facilities from the perspectives of managers, clinicians, patients, and ethics consultants. We conducted focus groups with patients (n = 32) and managers (n = 38); semi-structured interviews with managers (n = 31), clinicians (n = 55), and ethics committee chairpersons (n = 21). Data were analyzed using content analysis. Managers reported that the greatest ethical challenge was fairly distributing resources across programs and services, whereas clinicians identified the effect of resource constraints on patient care. Ethics committee chairpersons identified end-of-life care as the greatest ethical challenge, whereas patients identified obtaining fair, respectful, and caring treatment. Perspectives on ethical challenges varied depending on the respondent's role. Understanding these differences can help managers take practical steps to address these challenges. Further, ethics committees seemingly, are not addressing the range of ethical challenges within their institutions.

Economies of scale in institutional review boards.

BACKGROUND: Research with human subjects is essential for most clinical and social science research. As such, the ethical treatment of subjects, including the role of Institutional Review Boards (IRBs), is of paramount concern. The prevailing system of IRBs in the United States reflects an integrated approach in which research organizations have their own local IRB. Recent regulatory changes and a few high-profile problems have prompted proposals for greater investments in IRBs. OBJECTIVES: We conducted regression analyses, looking at how IRB size was associated with IRB costs (economies of scale). RESEARCH DESIGN: We studied data from a cross-sectional survey. SUBJECTS: We studied IRBs at Veterans Affairs (VA) and VA-affiliated medical centers (n = 109); 81 (73%) IRB administrators completed the survey. Fourteen of the administrators had missing data and were excluded from final analysis, leaving a sample of 67. MEASURES: The primary dependent variable was IRB costs in 2001, which we estimated from the survey. Independent variables included IRB size measured as the number of actions (ie, number of initial reviews, amendments, continuing/annual reviews, and harms/adverse event reports) reviewed by the IRB in the last year. RESULTS: The results indicate that very large economies of scale exist, especially for IRBs that handle fewer than 150 actions per year. CONCLUSIONS: A discussion of the costs of benefits of having 3000 to 5000 local IRBs in the United States is warranted because other organizational arrangements could be economically and socially advantageous.