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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.

SUBMITTER: Poplazarova T

PROVIDER: S-EPMC7482740 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The ecosystem services (ES) concept has emerged and spread widely recently, to enhance the importance of preserving ecosystems through global change in order to maintain their benefits for human well-being. Numerous studies consider various dimensions of the interactions between ecosystems and land use via ES, but integrated research addressing the complete feedback loop between biodiversity, ES and land use has remained mostly theoretical. Few studies consider feedbacks from ecosystems to land use systems through ES, exploring how ES are taken into account in land management decisions. To fill this gap, we carried out a role-playing game to explore how ES cognition mediates feedbacks from environmental change on farmers' behaviors in a mountain grassland system. On a close to real landscape game board, farmers were faced with changes in ES under climatic and socio-economic scenarios and prompted to plan for the future and to take land management decisions as they deemed necessary. The outcomes of role-playing game were complemented with additional agronomic and ecological data from interviews and fieldwork. The effects of changes in ES on decision were mainly direct, i.e. not affecting knowledge and values, when they constituted situations with which farmers were accustomed. For example, a reduction of forage quantity following droughts led farmers to shift from mowing to grazing. Sometimes, ES cognitions were affected by ES changes or by external factors, leading to an indirect feedback. This happened when fertilization was stopped after farmers learned that it was inefficient in a drought context. Farmers' behaviors did not always reflect their attitudes towards ES because other factors including topographic constraints, social value of farming or farmer individual and household characteristics also influenced land-management decisions. Those results demonstrated the interest to take into account the complete feedback loop between ES and land management decisions to favor more sustainable ES management.

Dataset Information

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

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