Case 2 Discussion
All adverse events are reported to the Data Safety Monitoring Board, and serious adverse events must be reported to the IRB. Investigators should consider reevaluating the balance of risks versus benefits. While these adverse events are probably not serious enough to suggest that the trial be terminated, these adverse events should be balanced by significant benefits. These findings may relate to each participant’s willingness to continue in the trial, and according to 45 CFR 46.116(b)(5) the findings should be provided to all current and future participants as part of the informed consent process.
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