Assessing research risks systematically: the net risks test.
Dual-track assessment directs research ethics committees (RECs) to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.
Wendler
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D
Department of Clinical Bioethics, The NIH Clinical Center, National Institutes of Health, Bethesda, MD, USA. dwendler@nih.gov
Miller
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FG
D035843:Biomedical Research / Q000941:ethics*; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000941:ethics*; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D033281:Nontherapeutic Human Experimentation / Q000941:ethics*; D035842:Research Subjects; D018570:Risk Assessment