42 USC 289b-1 - Protection against financial conflicts of interest in certain projects of research

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

(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.

(July 1, 1944, ch. 373, title IV, § 493A, as added Pub. L. 103–43, title I, § 164, June 10, 1993, 107 Stat. 142.)

cite as: 42 USC 289b-1

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