42 U.S.C. § 289b–1 — Protection against financial conflicts of interest in certain projects of research

(a) Defining and managing conflicts. The Secretary must, by regulation, define the specific situations where an entity or individual has a financial interest in a research project that will, or reasonably could, create a bias toward getting results that match that financial interest. This definition must apply the same way to every entity or individual doing research under this chapter. For entities or individuals getting the Secretary's assistance for a project described in subsection (b), the Secretary must, by regulation, set standards for responding to such a financial interest — including managing, reducing, or eliminating it. The entity may use its own procedures to carry out those standards. (b) Which projects this covers. This applies to a clinical research project whose purpose is to test whether a drug, medical device, or treatment is safe or effective, and for which the entity is getting the Secretary's assistance. (c) Identifying and reporting conflicts. The Secretary must, by regulation, require any entity described in subsection (a) that applies for assistance for a project described in subsection (b) to submit with its application: assurances that it has an administrative process to identify financial interests as defined under subsection (a); an agreement to report to the Secretary any interests it identifies and how they will be managed or eliminated so the project stays protected from bias; and an agreement to follow this section's regulations. (d) Monitoring. The Secretary must monitor how an entity sets up and runs its administrative process under subsection (a). (e) If an entity doesn't comply. If the Secretary decides an entity failed to comply with subsection (c) for a project described in subsection (b), the Secretary must require the entity, as a condition of continuing to get assistance, to publicly disclose the financial interest (as defined under subsection (a)) whenever it presents that project's results, and may also take other action the Secretary decides is appropriate. (f) Definitions. "Financial interest" includes consulting fees, honoraria, and stock or equity ownership. "Assistance," for a research project, means a grant, contract, or cooperative agreement.