Federally Funded Research and the IRB

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

About 6 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

If your site does research funded by the US National Institutes of Health (NIH) or another Public Health Service (PHS) agency, a second, stricter set of rules applies on top of FDA's. It has lower thresholds, a broader definition of who must disclose, mandatory training, and written management plans. An institution may apply the same standards to all of its research, not only federally funded studies; your institution's policy tells you whether it does.

This lesson is US law.

Which research it covers

42 CFR Part 50 Subpart F, "Promoting Objectivity in Research," applies to institutions applying for or receiving PHS research funding through a grant or cooperative agreement, and through them to each investigator planning to take part or taking part in that research. It does not apply to SBIR Program Phase I applications (42 CFR 50.602). A parallel rule, 45 CFR Part 94, covers PHS research funded through contracts (45 CFR 94.2).

Who is an investigator

Here the definition is deliberately wide: the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of the PHS-funded research (42 CFR 50.603). Depending on their role, that can include coordinators, research nurses, data managers and statisticians. Your institution decides who on your study meets the definition.

What a significant financial interest is

A significant financial interest (SFI) is an interest of the investigator, and of the investigator's spouse and dependent children, that reasonably appears related to the investigator's institutional responsibilities (42 CFR 50.603):

The definition excludes, among other things, salary and royalties paid by your own institution and income from mutual funds and retirement accounts that you do not directly control (42 CFR 50.603).

When investigators disclose

Training

The institution must require each investigator to complete training on its policy, the investigator's disclosure responsibilities and these regulations before engaging in PHS-funded research and at least every four years, and immediately when the institution changes its policy in a way that affects investigators, when an investigator is new to the institution, or when an investigator is found not in compliance (42 CFR 50.604(b)). Your institution decides which training meets this requirement; check before assuming any course does.

What the institution does with a disclosure

The designated official decides whether an SFI is related to the research and whether it is a financial conflict of interest: one that could directly and significantly affect the design, conduct or reporting of the research (42 CFR 50.603; 50.604(f)).

If it is, the institution develops a management plan before spending award funds, or within 60 days for a new disclosure during the award (50.605(a)(1) and (2)). The rule's examples of conditions include public disclosure; for human subjects research, disclosure directly to participants; an independent monitor; changing the research plan; changing personnel or their responsibilities, or disqualifying someone from all or part of the research; reducing or eliminating the interest; and severing the relationship (50.605(a)(1)(i) to (vii)). The institution monitors compliance with the plan until the project ends (50.605(a)(4)), reports conflicts to the funding agency (50.605(b)), and, before spending award funds, makes information about certain conflicts of senior and key personnel publicly accessible, on a public website or by a written response to any requester within five business days of a request (50.605(a)(5)).

If a conflict was not disclosed or managed on time, the institution must complete a retrospective review within 120 days of finding the noncompliance, to determine whether the research was biased (50.605(a)(3)). Disclosure records are kept for at least 3 years from the final expenditures report (50.604(i)).

What NIH adds

For NIH awards, the NIH Grants Policy Statement, section 4.1.10, repeats these duties as terms of the award. Institutions report each identified conflict to NIH in an initial report and then annual reports, through the eRA Commons FCOI Module. Investigators complete training before engaging in NIH-supported research and at least every four years. If your study is NIH funded, your institution's research office files these reports; your part is to disclose on time and follow any management plan.

The IRB's role

The IRB protects its own independence: a member with a conflicting interest may not take part in the IRB's initial or continuing review of that project, except to provide information the IRB requests (21 CFR 56.107(e); 45 CFR 46.107(d)). Many institutions also route conflict determinations and management plans to the IRB, which may require consent language or other protections. These federal sections do not themselves require conflict disclosure in the consent form; where it is required, the requirement comes from a management plan, the IRB or institutional policy.

Key takeaways

References