Certification for IRB Professionals (CIP) Practice Exam 2025 – The All-in-One Guide for Success!

Question: 1 / 400

How does IRB review differ for clinical trials versus observational studies?

Clinical trials often involve more rigorous scrutiny due to potential risks to participants

The correct answer states that clinical trials often undergo more rigorous scrutiny due to potential risks to participants. This is accurate as clinical trials typically involve interventions such as new drugs or medical devices, which can pose significant risks to the participants' health and safety. Consequently, Institutional Review Boards (IRBs) apply a thorough review process to ensure that the risks are minimized, that there are adequate provisions for monitoring participants, and that informed consent is adequately obtained.

In contrast, while observational studies may still require IRB review, they generally involve less risk since they typically collect data without intervening in participants' treatment or behavior. This distinction in potential risk profiles leads to a more extensive review process for clinical trials, emphasizing the need to safeguard participants against possible adverse effects related to experimental treatments.

Other options consider scenarios that either misrepresent the necessity or efficiency of the IRB review process in these types of research. Observational studies may indeed require IRB review, though it might be less intensive, and the suggestion that clinical trials would always be faster in the review process does not account for the complexity and ethical considerations involved. There is also a clear difference in review approaches based on the nature and impact of the research study being conducted.

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Observational studies require no IRB review

Clinical trials are always faster in the review process

There is no difference in the IRB review process

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