Certified Clinical Research Coordinator (CCRC) Practice Exam

What does IRB approval indicate in clinical research?

1. That clinical trials can begin without oversight

2. That a clinical trial has been reviewed and meets various requirements

3. That the trial has been successful in initial phases

4. That the funding for the trial has been secured

The correct answer is: That a clinical trial has been reviewed and meets various requirements

IRB approval indicates that a clinical trial has undergone a thorough review process by the Institutional Review Board, which is responsible for ensuring the protection of human subjects participating in research. This approval confirms that the trial meets established ethical standards and regulatory requirements. The IRB assesses several factors, including the study's protocol, informed consent procedures, risk/benefit analysis, and the safety and welfare of participants. The goal is to ensure that the rights and well-being of participants are safeguarded throughout the research process. By granting approval, the IRB essentially validates that the study is ethically sound and compliant with institutional and federal regulations, allowing the research to proceed under adequate oversight. In contrast, other options do not accurately reflect the purpose of IRB approval; for instance, it does not imply that trials can start without oversight, guarantee the success of a trial, or confirm that funding has been arranged. Each of these points addresses different aspects of research management that are distinct from the role of the IRB.