What is the primary concern of the IRB when reviewing a clinical trial?

The primary concern of the Institutional Review Board (IRB) when reviewing a clinical trial is participant safety. The IRB's main role is to protect the rights and welfare of human subjects involved in research. This includes assessing the risks involved in the study and ensuring that they are justified by the potential benefits. The IRB evaluates whether informed consent is adequate, considers the risk to benefit ratio, and examines how participants will be monitored throughout the trial.

While scientific validity, financial implications, and drug efficacy are important aspects of any clinical trial, they do not take precedence over the safety and protection of participants. Participants must be fully informed and protected from unnecessary harm, which is the cornerstone of ethical research practices. Thus, the primary responsibility of the IRB is to ensure that the safety and welfare of participants are prioritized in all phases of the research.