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Opinion

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

Julie C. Lumeng, Tabbye M. Chavous, Anna S. Lok, Srijan Sen, Nicholas S. Wigginton, and Rebecca M. Cunningham
PNAS November 10, 2020 117 (45) 27749-27753; first published October 21, 2020; https://doi.org/10.1073/pnas.2020507117
Julie C. Lumeng
aOffice of the Vice President for Research, University of Michigan, Ann Arbor, MI 48104;
bDepartment of Pediatrics, University of Michigan, Ann Arbor, MI 48109;
cDepartment of Nutritional Sciences, University of Michigan, Ann Arbor, MI 48109;
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Tabbye M. Chavous
aOffice of the Vice President for Research, University of Michigan, Ann Arbor, MI 48104;
dDepartment of Psychology, University of Michigan, Ann Arbor, MI 48109;
eDepartment of Educational Studies, University of Michigan, Ann Arbor, MI 48109;
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Anna S. Lok
fDivision of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI 48109;
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Srijan Sen
aOffice of the Vice President for Research, University of Michigan, Ann Arbor, MI 48104;
gDepartment of Psychiatry, University of Michigan, Ann Arbor, MI 48109;
hMichigan Neuroscience Institute, University of Michigan, Ann Arbor, MI 48109;
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Nicholas S. Wigginton
aOffice of the Vice President for Research, University of Michigan, Ann Arbor, MI 48104;
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  • For correspondence: stroh@med.umich.edu nwigg@umich.edu
Rebecca M. Cunningham
aOffice of the Vice President for Research, University of Michigan, Ann Arbor, MI 48104;
iDepartment of Emergency Medicine, University of Michigan, Ann Arbor, MI 48109;
jDepartment of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI 48109
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  • For correspondence: stroh@med.umich.edu nwigg@umich.edu
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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).

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    Table 1.

    Incremental risk of COVID-19 community transmission compared with benefit level and categorization of individual risk

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    • 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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Opinion: A risk–benefit framework for human research during the COVID-19 pandemic
Julie C. Lumeng, Tabbye M. Chavous, Anna S. Lok, Srijan Sen, Nicholas S. Wigginton, Rebecca M. Cunningham
Proceedings of the National Academy of Sciences Nov 2020, 117 (45) 27749-27753; DOI: 10.1073/pnas.2020507117

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Opinion: A risk–benefit framework for human research during the COVID-19 pandemic
Julie C. Lumeng, Tabbye M. Chavous, Anna S. Lok, Srijan Sen, Nicholas S. Wigginton, Rebecca M. Cunningham
Proceedings of the National Academy of Sciences Nov 2020, 117 (45) 27749-27753; DOI: 10.1073/pnas.2020507117
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Proceedings of the National Academy of Sciences: 117 (45)
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