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  1. The social value of clinical research.Michelle Gjl Habets, Johannes Jm van Delden & AnneLien L. Bredenoord - 2014 - BMC Medical Ethics 15 (1):66.
    International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used (...)
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  • (1 other version)A New Ethical Framework for Assessing the Unique Challenges of Fetal Therapy Trials: Response to Commentaries.Saskia Hendriks, Christine Grady, David Wasserman, David Wendler, Diana W. Bianchi & Benjamin Berkman - 2022 - American Journal of Bioethics 22 (3):45-61.
    New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk–benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. (...)
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