Research Ethics: Case 2
During the conduct of a large clinical trial of an investigational drug, preliminary analysis of results show that there were three times as many participants in the experimental group who experienced severe nausea and vomiting compared to the control group. Two of the cases were severe enough to require that the participants be hospitalized. This is despite the fact that the preliminary analysis shows that there may be a moderate benefit with the drug.
What should be done?
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.