Certification for IRB Professionals (CIP) Practice Exam

Which of the following statements about exempt research is true?

1. Exempt research does not require IRB review

2. Exempt research is always low-risk

3. Exempt research involves only minimal risk activities

4. Exempt research must be reviewed annually

The correct answer is: Exempt research does not require IRB review

The statement that exempt research does not require IRB review is accurate because it highlights a key characteristic of exempt research status. When research qualifies for exemption, it indicates that it poses no greater risk to participants than minimal risk or that it involves research procedures that are not objectionable. Consequently, these studies are not subject to the same level of scrutiny as research that requires full IRB review. It's important to note that although exempt research is not needed to undergo the full IRB review process, researchers are still required to determine whether their research meets the federal criteria for exemption. While the assertion that exempt research is always low-risk may seem plausible, it is not entirely accurate, as some exempt research can involve activities that are not purely low-risk. Similarly, stating that exempt research involves only minimal risk activities does not comprehensively define the scope of exempt research since not all exempt activities may fit neatly into the 'minimal risk' category. Lastly, the notion that exempt research must be reviewed annually misrepresents the requirements associated with exempt studies. Unlike research that requires continuing review, exempt studies do not have this annual review requirement, allowing for more flexibility in how they are managed once they are classified as exempt.