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Opinion: A risk–benefit framework for human research during the COVID-19 pandemic

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Performing human research during a global pandemic raises new ethical and practical challenges on a scale never before seen. To safely and ethically restart more of the human research portfolio, institutions must develop guiding principles and an explicit plan for managing human research during the pandemic. Image credit: Carey Lumeng (University of Michigan, Ann Arbor, MI).
Tables
- Table 1.
Incremental risk of COVID-19 community transmission compared with benefit level and categorization of individual risk
Activation tier is identified based on combining the feature of the study that provides the highest benefit to the individual participant in any study arm with the feature of the study that is in the highest risk category. If all face-to-face interaction with study participants occurs concurrent with a clinical encounter with no research staff, the study is classified as Tier 0, regardless of the risk or benefit category. Studies taking place outdoors will be given special consideration with regard to risk assessment. Number of contacts includes staff–participant contacts and participant–participant contacts (for group behavior studies).
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- Biological Sciences
- Medical Sciences