Certification for IRB Professionals (CIP) Practice Exam

The correct choice highlights a specific threshold established by the 1998 FDA regulations concerning the disclosure of significant financial interests. According to these regulations, any equity interest in a publicly held company that exceeds $50,000 must be disclosed. This rule is intended to ensure transparency and manage potential conflicts of interest in research, particularly when it involves federal funding or oversight.

By focusing on this monetary threshold, the regulations aim to protect the integrity of research and promote accuracy in reporting potential financial influences that may affect study outcomes or the interpretation of data. The emphasis on equity interests in publicly traded companies signifies the recognition of the potential impact that substantial financial stakes can have on the objectivity of the research.

The other choices do not align with the established guidelines: interests above $10,000 or all financial interests regardless of amount do not reflect the specific monetary threshold outlined by the FDA. Moreover, the reference to grants over $25,000 is not applicable in this context since the requirement specifically pertains to equity interests in publicly traded companies rather than grant amounts. This structure helps ensure that significant financial relationships are properly assessed in relation to the research being conducted.