Good Clinical Practice (GCP) Practice Exam

The primary focus of an Institutional Review Board (IRB) is centered on protecting the rights and well-being of trial subjects. This responsibility is crucial because it ensures that participants in clinical trials are treated ethically and that their safety is prioritized throughout the research process. The IRB reviews study protocols, informed consent documents, and any potential risks to participants before a trial can commence. This safeguards individuals from harm and guarantees that they are fully aware of the nature of their involvement in research.

In the context of clinical trials, the other options do not align with the core mission of an IRB. While regulating pharmaceutical companies is an important aspect of clinical research oversight, this duty typically falls to governmental regulatory agencies rather than IRBs. Developing new trial methods is more related to researchers and their scientific advancements rather than the ethical oversight role of an IRB. Marketing investigational products pertains to the promotional activities surrounding drugs and therapies, which is outside the scope of an IRB's responsibilities, as their focus is strictly on participant welfare during trials.