Which statement best describes the scope of the IRB/IEC's review?

• A. It focuses exclusively on ethical issues
• B. It covers science, medical aspects, and ethics of proposed trials
• C. It is limited to participant recruitment processes
• D. It only considers budget compliance

Answer: (B)

The main idea is that the IRB/IEC review covers both the science and the ethics of a proposed trial. It’s not limited to ethics alone, because ethical safeguards depend on a sound scientific basis and proper medical framing. The IRB evaluates the protocol for scientific and medical validity—things like study design, risk/benefit balance, inclusion and exclusion criteria, and plans for monitoring safety and data integrity. It also scrutinizes the informed consent process and materials to ensure participants are adequately informed and able to consent voluntarily. In addition to the initial review, the IRB continues to oversee ongoing safety, adverse events, and any protocol amendments to protect participants throughout the study. Budget or budget compliance isn’t the focus of the IRB’s review, which is why the statement that best describes the scope is that the review covers science, medical aspects, and ethics of proposed trials.