Clinical ethical consultants are subject to an unavoidable conflict of interest. Their work requires that they be independent, but incentives attached to their role chip relentlessly at independence. This that they be independent, is a problem without any solution, but it can at least be ameliorated through careful management.

Growing ties to private industry have prompted many to question the impartiality of academic bioethicists who receive financial support from for-profit corporations in exchange for ethics-related services and research. To the extent that corporate sponsors may view bioethics as little more than a way to strengthen public relations or avoid potential controversy, close ties to industry may pose serious threats to professional independence. New sources of support from private industry may also divert bioethicists from pursuing topics of greater social importance, (...) such as the needs of medically underserved communities. To inform ongoing debates about the financing of bioethics and its transparency to those concerned about potential sources of bias, we examined funding disclosures appearing in original research reports in major bioethics journals. Reviewing research published over a 15-year period, we found little evidence that for-profit corporations are influencing bioethics research directly. Instead, we found evidence that a great number of organizations, both public and private, support bioethics research. These findings suggest that worries about the cooption of bioethics research by a few interested stakeholders are greatly overstated and undersupported by available data. (shrink)

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)