CITI Program Biomedical Research Practice Exam 2025 – The Comprehensive All-in-One Guide for Exam Success!

Question: 1 / 400

What does an IRB's risk assessment typically conclude for studies involving children with minimal risks?

No risk to the child and no further review is needed

No more than minimal risk to the child

An Institutional Review Board (IRB) conducts risk assessments to ensure the safety and well-being of participants in research studies, especially vulnerable populations like children. In studies involving children, the typical conclusion regarding minimal risks indicates that the research poses no greater risk than what is encountered in daily life or during routine physical or psychological examinations.

By concluding that there is no more than minimal risk to the child, the IRB acknowledges that while any research inherently carries some level of risk, the potential for harm is limited and manageable. This conclusion helps to ensure that the research is ethically conducted, aligning with the overarching principle of protecting vulnerable populations from undue harm.

The other options suggest either no risk or levels of risk that exceed minimal risk, which would usually warrant more stringent review processes or different ethical considerations in the context of protecting child participants. The specific acknowledgment of only minimal risk ensures that the study aligns with ethical research practices while allowing advancement in knowledge and potential benefits for children.

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More than minimal risk with no prospect of benefit

More than minimal risk with direct benefits to the child

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