When to Disclose: Before, During and After the Study

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

About 5 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

The most common financial disclosure failure is not a false answer at start-up. It is a true answer that goes stale. An investigator signs the form in January, buys shares in the sponsor in June, and nobody updates anything. The FDA rules are written to prevent exactly that, and the update duty lasts longer than most people expect.

This lesson is US law for FDA-regulated studies.

Before participating

For drug and biological product studies under an investigational new drug application (IND), the sponsor must obtain, before permitting an investigator to begin participation, sufficient accurate financial information to allow complete and accurate certification or disclosure under Part 54. The sponsor must also obtain the investigator's commitment to promptly update that information (21 CFR 312.53(c)(4)).

For device studies under an investigational device exemption (IDE), the signed investigator agreement must include the same financial disclosure information and update commitment (21 CFR 812.43(c)(5)). For devices, this information is not submitted in the IDE application but is submitted in any marketing application (812.43(c)(5)).

In practice this means the financial disclosure form is a start-up document. A site should not treat an investigator or subinvestigator as ready to see participants until the form has been completed and sent as the sponsor directs.

Who completes it

The Part 54 definition covers each listed or identified investigator and subinvestigator directly involved in treating or evaluating subjects, plus the spouse and dependent children (21 CFR 54.2(d)). For drug studies, the investigator statement on Form FDA 1572 lists the subinvestigators who will assist (21 CFR 312.53(c)(1)(viii)), so sponsors commonly ask each person listed there for a form.

When a new subinvestigator joins mid-study, the same rule applies to them: the information should be collected before they begin participating. Adding someone to the delegation log without their financial disclosure is a gap a monitor will find.

During the study

The investigator's own duty is written into the investigator responsibilities. A clinical investigator must provide the sponsor with sufficient accurate financial information and must promptly update this information if any relevant changes occur during the course of the investigation (21 CFR 312.64(d) for drugs; 21 CFR 812.110(d) for devices; 21 CFR 54.4(b)).

Relevant changes include:

"Promptly" is not defined as a number of days in these sections. Your sponsor's or institution's procedure may set one. Follow the shorter of the two.

After the study

The update duty continues for 1 year following completion of the study (21 CFR 312.64(d); 812.110(d); 54.4(b)). The equity and payment thresholds look at the same window (21 CFR 54.2(b) and (f)). An investigator who becomes a paid consultant to the sponsor ten months after the last participant visit still has something to report.

Before the site closes the study, make sure each investigator knows this and knows whom to contact. Monitors may be gone by then; the sponsor's study contact list in the closeout file is a good place to record the route.

A related but separate system: Open Payments

Site staff sometimes confuse financial disclosure with Open Payments, the federal transparency program. Under 42 CFR 403.904, applicable manufacturers report payments and other transfers of value to covered recipients to the Centers for Medicare and Medicaid Services each year, and research-related payments are reported separately with their own data fields (403.904(f)). Covered recipients are physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse-midwives who are not employees of the manufacturer, and teaching hospitals (42 CFR 403.902).

Open Payments is reported by the manufacturer and is public. It does not replace your disclosure to the sponsor or to your institution, and a payment appearing there is not proof that it was disclosed where it needed to be.

In practice

Eight months after closeout, a principal investigator is invited to join the sponsor's paid advisory board. Before accepting, she emails the sponsor's study contact to update her financial disclosure for the completed study and tells her institution's conflict office. She keeps a copy of both messages in her own regulatory file.

Key takeaways

References