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

ABSTRACT

“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.

KEYWORDS:

• Ethical decision making
• human subject research
• bioethics
• values-based decision making
• value-based decision making
• biopharmaceutical
• research and development (R&D)
• bioindustry ethics
• decision making model
• decision making tool

Acknowledgments

We thank Sandrine Fontaine for her contribution to model development and implementation, as well as workshop delivery. Thanks are also due to Virginie Hamtiaux, Sami Liman, Christine Vanderlinden, Nathalie De Broux, Tuni Randall, Ana Hornillo, Louise Stevenson, Marie Bayle-Normand, Johannie Coenen, Philibert Goulet, Guglielmo Cervello and Birgit Van de Vliet of GSK Vaccines, and Aurore Jacques of Valesta, part of Oxford Global Resources, Mechelen, Belgium (on behalf of GSK Vaccines), for their respective contributions either to the model’s implementation, or workshop delivery.

We also thank Veronique Delpire and Mandy Payne of Words & Science, Brussels, Belgium (on behalf of GSK Vaccines) for their contributions in the form of editorial support, critical content review, bibliographical expertise and development of workshop material.

Contributors and sources

Tatjana Poplazarova had the original idea for combining GSK values with the 4 contextual factors that influence the choice of decision into a formal decision-making model, and she wrote the manuscript first draft. All three authors were responsible for the model development, its introduction and implementation; they participated in reviewing and editing the manuscript and approved the final version.

Disclosure of potential conflicts of interest

Tatjana Poplazarova, Claar van der Zee, and Thomas Breuer are full-time employees of the GSK group of companies and hold shares in the GSK group of companies as part of their employee remuneration.

Supplementary material

Supplemental data for this article can be accessed online at http://dx.doi.org/10.1080/21645515.2019.1700714.

Notes

1 We emphasize here a distinction between “values-based” and “value-based”. The term “value-based decision making” is widely used within the healthcare and business environments, and although there is no universally accepted definition, it frequently refers to considerations of financial or commercial nature (example: NHS England Value-Based Decision Making, https://www.england.nhs.uk/south/wp-content/uploads/sites/6/2016/09/value-based-decisions.pdf). In our article, we use the term values-based to make it clear that we refer specifically to organizational ethical or mission values.

2 https://uk.gsk.com/en-gb/careers/working-at-gsk/our-culture-and-values/.

Additional information

Funding

All costs related to the development of this manuscript were met by GSK Biologicals SA.