The Task Force Responds

Brody, Baruch A.; Dubler, Nancy Neveloff; Blustein, Jeff; Caplan, Arthur L.; Kahn, Jeffrey; Kass, Nancy E.; Lo, Bernard; Moreno, Jonathan; Sugarman, Jeremy; Zoloth, Laurie

doi:10.2307/3528109

Cited by 21 publications

(2 citation statements)

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“…Soliciting external expert input is another important exercise for navigating challenging issues; although the professional ethics of this practice is debated due to conflicts of interest and potential corporate pressure to tailor advice to commercial desires [5,[48][49][50][51]. Some, however, think the legitimate need for advice can be managed with methodology to mitigate these risks [5,52,53].…”

Section: Dual Missionsmentioning

confidence: 99%

Considerations for applying bioethics norms to a biopharmaceutical industry setting

et al. 2021

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Background The 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 text Any 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. Conclusion Understanding 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.

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Section: Dual Missionsmentioning

confidence: 99%

Considerations for applying bioethics norms to a biopharmaceutical industry setting

et al. 2021

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“…The American Society for Bioethics and Humanities (ASBH) and the American Society for Law, Medicine and Ethics (ASLME) (4) convened a task force to study the issue of bioethics consultation in the private sector. The Task Force prepared a report, which was published in the Hastings Center Report along with a critical response by Stuart Younger and Robert Arnold (5) and a Task Force response to the response (6). The Task Force Report addresses a number of issues relevant to private sector consultation and identifies factors bioethicsts should consider before engaging in private sector consulting as well as during the consultation process and after providing such services.…”

Section: Bioethics Consultation In the Private Sectormentioning

confidence: 99%