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Which Benefits Can Justify Risks in Research?

Tessa I van RijsselGhislaine J M W van ThielHelga GardarsdottirJohannes J M van Deldennull null
Published in: The American journal of bioethics : AJOB (2024)
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.
Keyphrases
  • clinical trial
  • randomized controlled trial
  • public health
  • machine learning
  • climate change
  • artificial intelligence
  • deep learning
  • big data
  • open label
  • phase ii