Which of the following types of studies generally require a more extensive IRB review?

Studies involving vulnerable populations require a more extensive IRB review because these groups may have limited autonomy, lower capacity to give informed consent, or may be at higher risk of exploitation. Vulnerable populations can include children, prisoners, pregnant women, and individuals with cognitive impairments, among others. When research involves these groups, the potential for coercion or undue influence increases, and the risk of harm—whether physical, psychological, or social—can be more pronounced. Consequently, the IRB must take greater care to ensure that appropriate safeguards are implemented to protect these participants, including ensuring informed consent processes are thorough and culturally sensitive. This heightened scrutiny also often includes considerations of how to minimize risks and ensure the equitable selection of subjects. Overall, the responsibility of the IRB to protect vulnerable populations demands a more comprehensive review process than studies that involve less at-risk populations.