Foundational Elements of an Ethical Decision-Making Model Applied in the Biopharmaceutical Context

Abstract

"We previously described an applied values-based decision-making model and reported on its use in biopharmaceutical research and development (R&D)*. The model, known by the acronym “TRIP &TIPP”, uses company values along with framing questions as part of a five-step process to guide decisions to complex questions. The employees are engaged as moral agents applying values and principles. Their moral intuition is guided by systematic use of explicit framing questions to increase the understanding and clarity of the values and contextual questions to facilitate the practical implementation of solutions. Sometimes these solutions lead to the creation of internal guidelines in the company. The ethical norms for biopharmaceutical R&D are shaped by the interaction between ethical reasoning and the context of the situation. Several levels of context are relevant here. First, that of the company within society, which is represented by the stakeholders in our model. This societal context is dynamic as societal expectations change over time. Second, the context of the employees within the company: how the company is organized, its mission, vision and values, as well as the capabilities, experiences and beliefs of the employees. Third, the specifics of the R&D question itself, which requires a pragmatic, solution-oriented, bioethical approach. Finally, ethical deliberation leads to evolving company practices addressing science, technology and society changes. "