According to the U.S. Food and Drug Administration (FDA) regulation 21 CFR Part 54, Financial Disclosure by Clinical Investigators, an investigator must disclose certain financial interests. An honorarium falls under the category of "Significant payment of other sorts." The regulation, specifically in section 54.2(d), defines this as payments from the sponsor to the investigator or institution with a monetary value of more than $25,000. This value is calculated exclusive of the costs of conducting the clinical study itself. Therefore, any honorarium from the sponsor of a covered study that exceeds this $25,000 threshold must be reported.

A. Any amount: This is incorrect. The regulation establishes a specific monetary threshold to avoid the burden of reporting trivial financial interests and focuses on those significant enough to potentially introduce bias.

B. $5,000: This is incorrect. The $5,000 threshold applies to a "significant equity interest" in a publicly traded company, not to payments such as honoraria, as defined in 21 CFR § 54.2(b).

C. $10,000: This is incorrect. This monetary value is not a specified threshold for reporting honoraria or other significant payments under the FDA's financial disclosure regulations (21 CFR Part 54).

1. U.S. Food and Drug Administration (FDA). Code of Federal Regulations Title 21, Part 54: Financial Disclosure by Clinical Investigators.

Reference: 21 CFR § 54.2(d).

Content: "Significant payment of other sorts means payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator that have a monetary value of more than $25,000, exclusive of the costs of conducting the clinical study or other clinical studies (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria)."

2. U.S. Food and Drug Administration (FDA). Guidance for Clinical Investigators, Sponsors, and IRBs: Financial Disclosure by Clinical Investigators. February 2013.

Reference: Section III. DEFINITIONS (21 CFR 54.2), subsection F.

Content: This guidance document reiterates and clarifies the definition from 21 CFR § 54.2(d), confirming that "Significant payments of other sorts (SPOOS)" include honoraria and have a reporting threshold of "more than $25,000."

3. Johns Hopkins University, Office of Policy Coordination. Policy on Individual Financial Interests and Financial Conflicts of Interest in Research.

Reference: Section II. Definitions, subsection "Significant Financial Interest".

Content: University policies for research compliance are based on federal regulations. This policy defines a Significant Financial Interest by referencing the PHS and FDA regulations, including the ">$25,000 for payments of other sorts" threshold from the FDA for covered clinical studies.