Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model.

"Values-based decision-making" frameworks and models are widely described in the literature in various disciplines, including healthcare settings. However, there is a paucity of literature on the application of systematic methods or models in the biopharmaceutical research and development (R&D) field of drugs, vaccines, and immunotherapeutics. In this report, we describe our model that uses company values along with framing questions in a five-step process to guide ethical decisions in the vaccines R&D context. The model uniquely supports practical prospective decision-making: employees are engaged as moral agents applying values and principles to guide their decision in a specific situation. We illustrate, by way of case studies, how the model is being used in practice. The consistent application of company values during decision-making calls upon employees to use their judgment, therefore reducing the need for the organization to systematically generate written instructions. Finally, we report on preliminary results of model adoption by teams within our organization, discuss its limitations and likely future contribution. We applied our model within a vaccines R&D context and believe its use can be extended to other areas where business-related decisions impact patients.