QQuestionEthics
QuestionEthics
The investigator must report adverse events to the:
A. Subject
B. Sponsor
C. FDA
D. IRB only
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Answer
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Step 1:Let me solve this research ethics problem systematically:
Step 2:: Understand the Context
This question relates to reporting adverse events in clinical research, which involves understanding the responsibilities of an investigator when unexpected or harmful events occur during a research study.
Step 3:: Define Key Terms
- Adverse Event: An unexpected medical occurrence or side effect during a research study - Investigator: The primary researcher responsible for conducting the study - IRB: Institutional Review Board - FDA: Food and Drug Administration - Sponsor: The organization funding or initiating the research
Step 4:: Analyze Reporting Requirements
In clinical research, investigators have multiple reporting obligations. However, the most critical and mandatory reporting requirement is to the IRB (Institutional Review Board).
Step 5:: Rationale for IRB Reporting
The IRB must be immediately notified of: - Any serious adverse events - Unanticipated problems - Risks to participant safety - Potential study protocol violations
Step 6:: Evaluate the Options
A. Subject - Incorrect (participants are informed, but not the primary reporting recipient) B. Sponsor - Partially correct (sponsors should be notified, but not the primary requirement) C. FDA - Not always required for all studies D. IRB - CORRECT primary reporting requirement
Final Answer
IRB only The IRB is the primary oversight body responsible for protecting human subjects and must be immediately informed of any adverse events that could impact participant safety or study integrity.
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