Quiz


IRB Home \| Historic Research \| Federal Regulations \| Sladen Library		Welcome Ethical Research Practice Institutional Review Board IRB Review Criteria Informed Consent Genetic Testing Types of Review Continuation & Final Reports Serious Adverse Events --Investigator Roles --Examples --Quiz Frequently Asked Questions Conclusion
Quiz 1. Reporting adverse events is the responsibility of: The Principal Investigator The Research Assistant The Research Nurse All of the above Incorrect. Although the Principal Investigator could report adverse events, it is not their responsibility alone. Think of the entire research team. Incorrect. Although the Research Assistant could report adverse events, it is not their responsibility alone. Think of the entire research team. Incorrect. Although the Research Nurse could report adverse events, it is not their responsibility alone. Think of the entire research team. You are correct! The Principal Investigator and the whole research team are responsible for reporting adverse events. If anyone on the team is concerned about adverse events, report them to the Principal Investigator or to the IRB Office. 2. An example of a reportable adverse event during research is: A mild adverse drug experience as described in the informed consent. A life-threatening adverse drug experience that is unanticipated and probably related to the research. Hospitalization of a subject that is part of the the research protocol. Incorrect. If the adverse drug experience is mild and described in the informed consent, it is probably not an adverse event that must be reported to the IRB. Incorrect. Although an unexpected or extended hospitalization is considered an adverse event, one that is part of the research protocol is not. Correct! A serious adverse effect that meets all 3 criteria (serious, unanticipated, and probably or definitely related to research) must be reported to the IRB for review. <<< Back

Quiz

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