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Which Benefits Can Justify Risks in Research?

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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 - May 2025

Keywords

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

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