Final answer:
In the context of clinical research, investigators must report adverse events to the Institutional Review Board (IRB) to ensure participant safety and ethical oversight.
Step-by-step explanation:
In the context of clinical research, the investigator must report adverse events primarily to the Institutional Review Board (IRB). The IRB is responsible for monitoring the safety and ethical treatment of human subjects in research studies. Adverse event reporting is a critical aspect of clinical trials as it ensures participant safety and contributes to the assessment of the drugs risk-benefit profile. The sponsor also has obligations to review and report adverse drug experiences to the FDA, especially serious and unexpected events, within a specific timeline. Furthermore, the Food and Drug Administration (FDA) may receive direct reports through its MedWatch program.
However, when speaking about the investigator's immediate obligations, the IRB is the entity to which they must report, as it is the committee that oversees the study's ethical conduct. Ensuring the safety of participants is a paramount concern, and part of this safety protocol includes prompt reporting of any adverse findings to the IRB, sponsor, and potentially other official bodies, depending on the severity of the events and the established reporting guidelines.