BackgroundThe biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main textAny institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that (...) arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context “specification” substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity.ConclusionUnderstanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society. (shrink)

Background:Ethics consultation is the traditional way of resolving challenging ethical questions raised about patient care in the United States. Little research has been published on the resolution process used during ethics consultations and on how this experience affects healthcare professionals who participate in them.Objectives:The purpose of this qualitative research was to uncover the basic process that occurs in consultation services through study of the perceptions of healthcare professionals.Design and Method:The researchers in this study used a constructivist grounded theory approach that (...) represents how one group of professionals experienced ethics consultations in their hospital in the United States.Results:The results were sufficient to develop an initial theory that has been named after the core concept: Moving It Along. Three process stages emerged from data interpretation: moral questioning, seeing the big picture, and coming together. It is hoped that this initial work stimulates additional research in describing and understanding the complex social process that occurs for healthcare professionals as they address the difficult moral issues that arise in clinical practice. (shrink)

This paper offers an exposition of what the question of method in ethics consultation involves under two conditions: when ethics consultation is regarded as a practice and when the question of method is treated systematically. It discusses the concept of the practice and the importance of rules in constituting the actions, cognition, and perceptions of practitioners. The main body of the paper focuses on three elements of the question of method: canon, discipline, and history, which are treated heuristically to outline (...) what the question of method in ethics consultation fully involves. (shrink)