Certification for IRB Professionals (CIP) Practice Exam

Can an investigator independently determine the exempt status of their research?

1. Yes

2. No

3. Only with IRB approval

4. Yes, but only for minimal risk studies

The correct answer is: No

An investigator cannot independently determine the exempt status of their research because that determination must adhere to specific regulatory criteria established by the federal regulations governing human subjects research, namely the Common Rule (45 CFR 46). These regulations define certain categories of research that may be considered exempt. While investigators may have familiarity with these criteria, the formal assessment of whether the research qualifies for exemption typically requires input and approval from a qualified Institutional Review Board (IRB). This ensures that the review process maintains objectivity and compliance with ethical standards, and protects the rights and welfare of participants. The IRB serves as a check to ensure that the research aligns with federal regulations and institutional policies. Therefore, the responsibility lies with the IRB to evaluate the research proposal, ensuring that all necessary conditions for exemption are adequately met before deeming a study as exempt from IRB review. This process fosters ethical oversight and safeguards against potential misconduct or harm to participants, making it imperative for investigators to seek IRB engagement in the determination of exempt status.