Abstract
Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs.
Original language | English |
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Pages (from-to) | 65-75 |
Number of pages | 11 |
Journal | American Journal of Bioethics |
Volume | 25 |
Issue number | 5 |
Early online date | 5 Jan 2024 |
DOIs | |
Publication status | Published - 2025 |
Bibliographical note
Publisher Copyright:© 2024 The Author(s). Published with license by Taylor & Francis Group, LLC.
Funding
The authors thank Rieke van der Graaf and colleagues from the Bioethics and Health Humanities department for their valuable input on earlier versions of this work.
Funders | Funder number |
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Innovative Medicines Initiative |
Keywords
- Ethics committees
- IRB (Institutional Review Board)
- decentralized clinical trials
- research benefits
- research ethics
- risk/benefit analysis