Which of the following is NOT a valid reason for expediting a study review by the IRB?

The correct answer identifies a scenario that does not justify expediting the review process by the Institutional Review Board (IRB). When research involves vulnerable populations without adequate safeguards, it is crucial to thoroughly assess the potential risks and ethical considerations associated with the study. Vulnerable populations are at a higher risk for coercion or undue influence, necessitating a more comprehensive review to ensure their protection. The IRB is tasked with ensuring that the rights and welfare of all participants are adequately safeguarded, particularly in cases where potential risks are heightened.

In contrast, the other reasons listed can legitimately support a request for expedited review. Studies that impose minimal risk or fit into one of the federally defined expedited categories are eligible for faster assessment because they are typically seen as less likely to harm participants. Moreover, a researcher's history of prompt reporting and compliance suggests a reliable track record, which can lead the IRB to consider their new submission for expedited review.

Overall, prioritizing thorough reviews of studies involving vulnerable populations aligns with ethical standards and the IRB's responsibility to protect participants, justifying the exclusion of such circumstances from expedited processing.