§289b–1 — Title 42 The Public Health and Welfare | U.S. Code

Summary

The Secretary must write rules that say when a person or organization has a financial interest in a research project that could make the results biased. The rules must apply to everyone doing research under this law. For clinical studies that test how safe or effective a drug, device, or treatment is, and that get help from the Secretary, the Secretary must also set standards for handling those financial interests. Organizations can make their own detailed procedures to follow the standards. Any group asking for that help must promise it has a process to find financial interests, agree to report any found interests and explain how they will be managed or removed, and agree to follow the rules. The Secretary will check these processes. If a group does not comply, the Secretary can require the group to disclose the financial interests when sharing results publicly and can take other actions as needed. Definitions: financial interest — includes consulting pay, honoraria, and owning stock or equity; assistance — means a grant, contract, or cooperative agreement.

Title 42, §289b–1

The Public Health and Welfare — Source: USLM XML via OLRC

(a)The Secretary shall by regulation define the specific circumstances that constitute the existence of a financial interest in a project on the part of an entity or individual that will, or may be reasonably expected to, create a bias in favor of obtaining results in such project that are consistent with such financial interest. Such definition shall apply uniformly to each entity or individual conducting a research project under this chapter. In the case of any entity or individual receiving assistance from the Secretary for a project of research described in subsection (b), the Secretary shall by regulation establish standards for responding to, including managing, reducing, or eliminating, the existence of such a financial interest. The entity may adopt individualized procedures for implementing the standards.

(b)A project of research referred to in subsection (a) is a project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment and for which such entity is receiving assistance from the Secretary.

(c)The Secretary shall by regulation require that each entity described in subsection (a) that applies for assistance under this chapter for any project described in subsection (b) submit in or with its application for such assistance—

(1)assurances satisfactory to the Secretary that such entity has established and has in effect an administrative process under subsection (a) to identify financial interests (as defined under subsection (a)) that exist regarding the project; and

(2)an agreement that the entity will report to the Secretary such interests identified by the entity and how any such interests identified by the entity will be managed or eliminated in order that the project in question will be protected from bias that may stem from such interests; and

(3)an agreement that the entity will comply with regulations issued under this section.

(d)The Secretary shall monitor the establishment and conduct of the administrative process established by an entity pursuant to subsection (a).

(e)In any case in which the Secretary determines that an entity has failed to comply with subsection (c) regarding a project of research described in subsection (b), the Secretary—

(1)shall require that, as a condition of receiving assistance, the entity disclose the existence of a financial interest (as defined under subsection (a)) in each public presentation of the results of such project; and

(2)may take such other actions as the Secretary determines to be appropriate.

(f)For purposes of this section:

(1)The term “financial interest” includes the receipt of consulting fees or honoraria and the ownership of stock or equity.

(2)The term “assistance”, with respect to conducting a project of research, means a grant, contract, or cooperative agreement.

Statutory Notes and Related Subsidiaries

Regulations

Final rule for

Regulations

required in this section to be issued not later than 180 days after June 10, 1993, see section 165 of Pub. L. 103–43, set out as a note under section 289b of this title.

§289b–1 Protection against financial conflicts of interest in certain projects of research

Summary

Title 42, §289b–1

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Regulations

Regulations

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