The IRB's role includes which of the following?

• A. assures that a clinical trial is ethical and the rights of the study participants are protected
• B. determines market potential
• C. monitors hospital expenditures
• D. signs contracts with sponsors

Answer: (A)

The key idea is that the IRB exists to protect people in research. Its job is to review the study plan to ensure it is ethical, that risks to participants are minimized and reasonable in relation to potential benefits, and that participants’ rights and welfare are safeguarded. This includes making sure informed consent is appropriate and understandable, that privacy and confidentiality are protected, and that there’s ongoing monitoring of safety during the study. Because of these duties, the IRB’s focus is ethical oversight and participant protection, not business or contractual tasks. Therefore, the statement that the IRB assures the trial is ethical and protects participants’ rights best captures its role.