[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR94.4]



[Page 479]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           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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