
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC289b-1]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
                       Part H--General Provisions
 
Sec. 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) of this section, 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

    A project of research referred to in subsection (a) of this section 
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) of this section that applies for assistance under this 
chapter for any project described in subsection (b) of this section 
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) of this section to identify financial interests (as 
    defined under subsection (a) of this section) 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) of this section.

(e) Response

    In any case in which the Secretary determines that an entity has 
failed to comply with subsection (c) of this section regarding a project 
of research described in subsection (b) of this section, 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) of this section) 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, Sec. 493A, as added Pub. L. 103-43, 
title I, Sec. 164, June 10, 1993, 107 Stat. 142.)


                               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.
