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Ethics in the Interim: Learning from the COVID-19 pandemic to develop ethical guidance for data and safety monitoring committees overseeing clinical trials

Seema Shah, JD
Ann & Robert H. Lurie Children’s Hospital of Chicago
Grant Type Making a Difference
Grant Cycle spring 2021
Duration 24
Amount $219,685

The COVID-19 pandemic has revealed major gaps in research oversight, particularly regarding data and safety monitoring boards (DSMBs). DSMBs dynamically integrate uncertain information to determine whether to prematurely stop or otherwise modify trials. This makes DSMB ethics conceptually interesting as well as operationally challenging. Taking a mixed-methods approach, this project proposes to develop a pragmatic ethical framework and model charter to explicitly address the ethical considerations embedded in DSMB determinations, including in contexts of rapidly evolving evidence and policy.

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