A researcher's study examining prisoner demographic characteristics claims it is exempt from IRB review. What is the primary reason this claim is incorrect?

The primary reason the claim about the study being exempt from IRB review is incorrect lies in the stipulations set forth regarding research involving prisoners. Specifically, the regulation known as 46.104 clarifies that research conducted in prisons does not qualify for exemption if the research exclusively involves prisoners as the subject population. This is rooted in the heightened ethical considerations and safeguards that need to be in place when researching vulnerable populations, like prisoners, who may have limited autonomy and be at greater risk for coercion.

The intention behind this regulation is to ensure that the rights and welfare of prisoners are adequately protected, necessitating that all research involving them undergoes a thorough review process by an Institutional Review Board (IRB). This requirement reflects a more stringent ethical standard to mitigate any potential exploitation or harm that could arise in a prison setting, where individuals may feel pressured to participate in research studies. Therefore, the assertion that the research is exempt simply because it focuses on prisoner demographics fails to acknowledge these critical protections that are mandated by federal regulations, validating the correctness of the answer provided.