[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR94.4]

[Page 468]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 94_RESPONSIBLE PROSPECTIVE CONTRACTORS--Table of Contents
 
Sec. 94.4  Institutional responsibility regarding conflicting interests of investigators.

    Each Institution must:
    (a) Maintain an appropriate written, enforced policy on conflict of 
interest that complies with this part and inform each Investigator of 
that policy, the Investigator's reporting responsibilities, and of these 
regulations. If the Institution carries out the PHS-funded research 
through subcontractors, or collaborators, the Institution must take 
reasonable steps to ensure that Investigators working for such entities 
comply with this part, either by requiring those Investigators to comply 
with the Institution's policy or by requiring the entities to provide 
assurances to the Institution that will enable the Institution to comply 
with this part.
    (b) Designate an institutional official(s) to solicit and review 
financial disclosure statements from each Investigator who is planning 
to participate in PHS-funded research.
    (c)(1) Require that by the time an application is submitted to PHS, 
each Investigator who is planning to participate in the PHS-funded 
research has submitted to the designated official(s) a listing of his/
her known Significant Financial Interests (and those of his/her spouse 
and dependent children):
    (i) that would reasonably appear to be affected by the research for 
which PHS funding is sought; and
    (ii) in entities whose financial interests would reasonably appear 
to be affected by the research.
    (2) All financial disclosures must be updated during the period of 
the award, either on an annual basis or as new reportable Significant 
Financial Interests are obtained.
    (d) Provide guidelines consistent with this part for the designated 
official(s) to identify conflicting interests and take such actions as 
necessary to ensure that such conflicting interests will be managed, 
reduced, or eliminated.
    (e) Maintain records of all financial disclosures and all actions 
taken by the Institution with respect to each conflicting interest for 
three years after final payment or, where applicable, for the other time 
periods specified in 48 CFR part 4, subpart 4.7.
    (f) Establish adequate enforcement mechanisms and provide for 
sanctions where appropriate.
    (g) Certify, in each contract proposal, that:
    (1) there is in effect at that Institution a written and enforced 
administrative process to identify and manage, reduce or eliminate 
conflicting interests with respect to all research projects for which 
funding is sought from the PHS;
    (2) prior to the Institution's expenditure of any funds under the 
award, the Institution will report to the PHS Awarding Component the 
existence of any conflicting interest (but not the nature of the 
interest or other details) found by the Institution and assure that the 
interest has been managed, reduced or eliminated in accordance with this 
part; and, for any interest that the Institution identifies as 
conflicting subsequent to the Institution's initial report under the 
award, the report will be made and the conflicting interest managed, 
reduced, or eliminated, at least on an interim basis, within sixty days 
of that identification.
    (3) the Institution agrees to make information available, upon 
request, to the HHS regarding all conflicting interests identified by 
the Institution and how those interests have been managed, reduced, or 
eliminated to protect the research from bias; and
    (4) the Institution will otherwise comply with this part.

[60 FR 35817, July 11, 1995; 60 FR 39076, July 31, 1995]

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