FDA Financial Disclosure: What Counts and the Thresholds

Part of Conflict of Interest in Clinical Research: The US Rules.

About 7 minutes. Free, in your language, no account needed.

Expert review pending. CRLN wrote this lesson against the primary sources listed under References. A subject-matter expert has not yet reviewed it. Where your institution's policy or your sponsor's instructions are stricter, follow them.

Why this matters

In the United States, the rule site staff meet most often is FDA's financial disclosure rule, 21 CFR Part 54. It is the reason sponsors send every investigator a financial disclosure form at start-up. Knowing what the form is asking, and why, helps you complete it accurately and spot when an answer needs updating.

This lesson is US law. It applies to FDA-regulated studies of drugs, biological products and devices.

Who the rule is aimed at

Part 54 places the reporting duty on the applicant: the company that submits a marketing application to FDA (21 CFR 54.2(g) and 54.3). For each covered clinical study, the applicant lists every clinical investigator, identifies those who are employees of the sponsor, and for the others either certifies that no disclosable arrangement exists or discloses it (21 CFR 54.4).

The applicant can only do that if investigators give it accurate information. That is where the site comes in, and Lesson 2 covers the investigator's own duty.

Who counts as a clinical investigator

For Part 54, a clinical investigator is a listed or identified investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects. The term also includes the spouse and each dependent child of the investigator (21 CFR 54.2(d)).

Two practical points follow. First, the person completing the form must think about household interests, not only their own. Second, staff who are not investigators or subinvestigators, such as many coordinators, are generally outside this federal definition, but your sponsor or institution may still ask them to disclose.

Which studies are covered

A covered clinical study is one the applicant or FDA relies on to show the product is effective, or one in which a single investigator makes a significant contribution to showing safety. The rule says this would generally not include phase 1 tolerance studies, pharmacokinetic studies, most clinical pharmacology studies (unless critical to an efficacy determination), large open safety studies at multiple sites, treatment protocols and parallel track protocols (21 CFR 54.2(e)).

Because nobody at a site can know in advance how a study will be used in an application, sponsors commonly collect forms for all their studies. Complete the form whenever you are asked.

The four kinds of disclosable interest

1. Compensation affected by the outcome. Compensation that could be higher for a favorable outcome than an unfavorable one, such as payment explicitly greater for a favorable result, equity in the sponsor, or a royalty tied to sales (21 CFR 54.2(a)).

2. Significant equity interest in the sponsor. Any ownership interest, stock options or other financial interest whose value cannot be readily determined through public prices (generally, interests in a company that is not publicly traded), or any equity interest in a publicly traded company that exceeds $50,000, during the time the investigator is carrying out the study and for 1 year after it is completed (21 CFR 54.2(b)).

Notice the asymmetry. In a private company, any equity counts. In a public company, the threshold is more than $50,000.

3. Proprietary interest in the tested product. Property or other financial interest in the product, including a patent, trademark, copyright or licensing agreement (21 CFR 54.2(c)). There is no dollar threshold.

4. Significant payments of other sorts. Payments from the sponsor to the investigator or the institution to support the investigator's activities, worth more than $25,000, not counting the costs of conducting the clinical study or other clinical studies. Examples in the rule are a grant to fund ongoing research, equipment, a retainer for ongoing consultation, and honoraria. The window is the time the investigator is carrying out the study and 1 year after completion (21 CFR 54.2(f)).

Per-participant study payments under the clinical trial agreement are costs of conducting the study and are not this category. Consulting fees, speaker honoraria and research grants from the same sponsor can be.

Forms FDA 3454 and 3455

The applicant reports using two forms:

• Form FDA 3454 is a certification that none of the disclosable arrangements exist. It is dated and signed by the chief financial officer or another responsible corporate official (21 CFR 54.4(a)(1)).
• Form FDA 3455 is a disclosure statement for any investigator the applicant cannot certify. It describes each arrangement or interest and any steps taken to minimize the potential for bias (21 CFR 54.4(a)(3)).

These are the applicant's forms. At the site you usually complete the sponsor's own questionnaire, which feeds them.

If the applicant cannot get the information despite due diligence, it must certify that and give the reason (21 CFR 54.4). The applicant keeps the underlying financial records for 2 years after the application is approved (21 CFR 54.6(b)).

What FDA's guidance adds

FDA's 2013 guidance is not binding, but it explains how FDA reads the rule:

• The $25,000 is cumulative. It counts all significant payments of other sorts to the clinical investigator, including payments to the spouse and dependent children, over the whole study and for 1 year after it ends. It is not an annual amount (guidance, Question C.6).
• Thresholds apply per sponsor. The amounts apply separately for each sponsor of the study, and are added together for the investigator, spouse and dependent children (guidance, Appendix).
• Who usually counts. A clinical investigator generally includes anyone who signs Form FDA 1572 or is named as an investigator or subinvestigator in the IND or the application. FDA expects at least one at each site. Staff who give only ancillary or intermittent care, or who only collect specimens or do routine tests such as blood pressure, EKG or x-ray, are not meant to be included (guidance, Question D.2).

Sponsors may collect this with their own questionnaire (guidance, Question C.7), so forms differ.

In practice

A subinvestigator's spouse owns $60,000 of shares in the publicly traded sponsor. On the sponsor's form she answers yes to the equity question and gives the value. She does not decide for herself that it is unimportant because the shares are her spouse's. The definition includes the spouse, and the amount exceeds $50,000.

Key takeaways

• Part 54 makes the marketing applicant report investigator financial interests to FDA, using Form FDA 3454 (certification) or 3455 (disclosure).
• "Clinical investigator" means investigators and subinvestigators directly involved in treating or evaluating subjects, plus their spouses and dependent children.
• Disclosable: outcome-linked compensation, proprietary interests, equity in a private sponsor, public equity over $50,000, and other sponsor payments over $25,000.
• The equity and payment windows run through the study and for 1 year after it ends.
• FDA's guidance: the $25,000 is cumulative over the study plus 1 year, and thresholds apply per sponsor.

References

• 21 CFR Part 54: 54.1, 54.2(a) to (g), 54.3, 54.4(a), 54.6, eCFR (up to date as of 2026-11-09).
• FDA, Financial Disclosure by Clinical Investigators, Guidance for Clinical Investigators, Industry, and FDA Staff, February 2013 (FDA-1999-D-0742), Questions C.6, C.7 and D.2 and the Appendix. Contains nonbinding recommendations.