When must the investigator update the IRB about the progress of a trial?

The requirement for an investigator to update the Institutional Review Board (IRB) about the progress of a trial encompasses both the duration of the study and its termination. Throughout the conduct of the study, the investigator must provide regular updates on any significant changes, adverse events, or pertinent developments that could impact the safety of participants or the integrity of the study. This ongoing communication ensures that the IRB can monitor the study effectively and assess whether the research continues to meet ethical standards.

Additionally, at the conclusion of the study, the investigator must also report the results and any relevant findings. This final report allows the IRB to review the overall conduct and outcomes of the trial, including the efficacy and safety of the intervention being studied. Collectively, these updates during the study and at its termination uphold the ethical guidelines and regulatory requirements for human subjects research, maintaining participant safety and the integrity of the research process.