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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Main Authors: Tatjana Poplazarova, Claar van der Zee, Thomas Breuer
Format: Article
Language:English
Published: Taylor & Francis Group 2020-08-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
Online Access:http://dx.doi.org/10.1080/21645515.2019.1700714
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author Tatjana Poplazarova
Claar van der Zee
Thomas Breuer
author_facet Tatjana Poplazarova
Claar van der Zee
Thomas Breuer
author_sort Tatjana Poplazarova
collection DOAJ
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 doaj.art-a204630ebb304de980c23198f00d58052023-09-22T08:45:35ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-08-011681981198810.1080/21645515.2019.17007141700714Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP modelTatjana Poplazarova0Claar van der Zee1Thomas Breuer2GSK VaccinesGSK VaccinesGSK Vaccines“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.http://dx.doi.org/10.1080/21645515.2019.1700714ethical decision makinghuman subject researchbioethicsvalues-based decision makingvalue-based decision makingbiopharmaceuticalresearch and development (r&d)bioindustry ethicsdecision making modeldecision making tool
spellingShingle Tatjana Poplazarova
Claar van der Zee
Thomas Breuer
Ethical decision-making in biopharmaceutical research and development: applying values using the TRIP & TIPP model
Human Vaccines & Immunotherapeutics
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
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 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
url http://dx.doi.org/10.1080/21645515.2019.1700714
work_keys_str_mv AT tatjanapoplazarova ethicaldecisionmakinginbiopharmaceuticalresearchanddevelopmentapplyingvaluesusingthetriptippmodel
AT claarvanderzee ethicaldecisionmakinginbiopharmaceuticalresearchanddevelopmentapplyingvaluesusingthetriptippmodel
AT thomasbreuer ethicaldecisionmakinginbiopharmaceuticalresearchanddevelopmentapplyingvaluesusingthetriptippmodel