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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)...

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Autores principales: Poplazarova, Tatjana, van der Zee, Claar, Breuer, Thomas
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7482740/
https://www.ncbi.nlm.nih.gov/pubmed/31939717
http://dx.doi.org/10.1080/21645515.2019.1700714
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author Poplazarova, Tatjana
van der Zee, Claar
Breuer, Thomas
author_facet Poplazarova, Tatjana
van der Zee, Claar
Breuer, Thomas
author_sort Poplazarova, Tatjana
collection PubMed
description “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.
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spelling pubmed-74827402020-09-16 Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model Poplazarova, Tatjana van der Zee, Claar Breuer, Thomas Hum Vaccin Immunother Commentary “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. Taylor & Francis 2020-01-15 /pmc/articles/PMC7482740/ /pubmed/31939717 http://dx.doi.org/10.1080/21645515.2019.1700714 Text en © 2020 GlaxoSmithKline Biologicals SA. Published with license by Taylor & Francis Group, LLC. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Commentary
Poplazarova, Tatjana
van der Zee, Claar
Breuer, Thomas
Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model
title Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model
title_full Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model
title_fullStr Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model
title_full_unstemmed Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model
title_short Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model
title_sort ethical decision-making in biopharmaceutical research and development: applying values using the trip & tipp model
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7482740/
https://www.ncbi.nlm.nih.gov/pubmed/31939717
http://dx.doi.org/10.1080/21645515.2019.1700714
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