42 USC 289b-1 – Protection against financial conflicts of interest in certain projects of research
(a) Issuance of regulations
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) Relevant projects
Terms Used In 42 USC 289b-1
- clinical research: means patient oriented clinical research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials. See 42 USC 284d
- Contract: A legal written agreement that becomes binding when signed.
- individual: shall include every infant member of the species homo sapiens who is born alive at any stage of development. See 1 USC 8
- Secretary: means the Secretary of Health and Human Services. See 42 USC 201
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) Identifying and reporting to Secretary
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) Monitoring of process
The Secretary shall monitor the establishment and conduct of the administrative process established by an entity pursuant to subsection (a).
(e) Response
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) Definitions
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.