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Assessing research risks systematically: the net risks test
  1. D Wendler,
  2. F G Miller
  1. Department of Clinical Bioethics, The NIH Clinical Center, National Institutes of Health, Bethesda, Maryland, USA
  1. Correspondence to:
 D Wendler
 Building 10, Room 1C118, NIH, Bethesda, MD 20892, USA; dwendler{at}nih.gov

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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.

Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission (NBAC) notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1

The NBAC, as well as numerous commentators, recommend that research ethics committees (RECs), ethics review committees and institutional review boards (IRBs) should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.

BACKGROUND

Clinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …

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