Which Benefits Can Justify Risks in Research?

Trials@Home Consortium, Tessa I van Rijssel, Ghislaine J M W van Thiel, Helga Gardarsdottir, Johannes J M van Delden

Research output: Contribution to journalArticleAcademicpeer-review

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 languageEnglish
Pages (from-to)65-75
Number of pages11
JournalAmerican Journal of Bioethics
Volume25
Issue number5
Early online date5 Jan 2024
DOIs
Publication statusPublished - 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.

FundersFunder number
Innovative Medicines Initiative

    Keywords

    • Ethics committees
    • IRB (Institutional Review Board)
    • decentralized clinical trials
    • research benefits
    • research ethics
    • risk/benefit analysis

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