What role does the Institutional Review Board (IRB) play in clinical trials?

Prepare for the CITI Good Clinical Practice (GCP) Exam with comprehensive questions, hints, and explanations. Master the essential concepts to excel in your exam!

The role of the Institutional Review Board (IRB) in clinical trials is primarily centered around protecting the rights and welfare of research participants. The IRB is responsible for evaluating research proposals to ensure that ethical standards are maintained and that the potential risks to participants are minimized. This involves reviewing informed consent processes, assessing the study's risk-benefit ratio, and ensuring that participants are adequately informed about the nature and purpose of the study before agreeing to participate.

The IRB plays a critical role in ensuring that participants' rights are upheld throughout the research process. This includes monitoring ongoing trials to ensure compliance with ethical standards and regulations, providing oversight to facilitate the safe conduct of research, and intervening if ethical considerations arise during the study.

In contrast, managing funding, overseeing trial operations, or conducting the trial are not within the primary responsibilities of the IRB. These aspects fall under the purview of the study sponsor, clinical research coordinators, and investigators, who are responsible for the practical execution and financial management of the trial.

Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy