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

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

• A. The study imposes no more than minimal risk
• B. The research involves vulnerable populations without safeguards
• C. The study fits into one of the federally specified expedited categories
• D. The researcher has a history of prompt reporting and compliance

Answer: (B)

The option that is not a valid reason for expediting a study review by the Institutional Review Board (IRB) is related to the involvement of vulnerable populations without safeguards. Expedited review procedures are designed to streamline the review process for studies that present minimal risk to participants, and they are applicable to specific categories of research defined by regulatory guidelines. When a study involves vulnerable populations, such as prisoners, children, or individuals with cognitive impairments, additional protections and safeguards are typically required. The presence of vulnerable populations without adequate safeguards raises ethical and safety concerns. In such cases, expedited review is generally inappropriate because these studies would likely require a more thorough review to ensure that the research complies with ethical standards and that participants are protected appropriately. Thus, involving vulnerable populations without safeguards would negate the justification for an expedited review, as the need for additional protections is paramount.

The option that is not a valid reason for expediting a study review by the Institutional Review Board (IRB) is related to the involvement of vulnerable populations without safeguards. Expedited review procedures are designed to streamline the review process for studies that present minimal risk to participants, and they are applicable to specific categories of research defined by regulatory guidelines. When a study involves vulnerable populations, such as prisoners, children, or individuals with cognitive impairments, additional protections and safeguards are typically required.

The presence of vulnerable populations without adequate safeguards raises ethical and safety concerns. In such cases, expedited review is generally inappropriate because these studies would likely require a more thorough review to ensure that the research complies with ethical standards and that participants are protected appropriately. Thus, involving vulnerable populations without safeguards would negate the justification for an expedited review, as the need for additional protections is paramount.