CITI Training Practice Exam

The appropriate course of action when a participant experiences adverse effects during a study is to report the adverse event to the Institutional Review Board (IRB) and take necessary action. This response is crucial because the IRB is responsible for protecting the rights and welfare of participants involved in research. Reporting the adverse event allows the IRB to assess the situation, evaluate the safety of the study, and determine if any modifications or additional safeguards are necessary.

Furthermore, taking necessary action may include providing medical care to the affected participant, ensuring they are safe, and possibly pausing the study to assess risks. This response aligns with ethical research practices that prioritize participant safety and well-being over the continuity of data collection. Continuously monitoring and responding to adverse events also helps maintain the integrity of the research process and ensures compliance with regulatory standards.