[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: 45CFR94.6]



[Page 480]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 94_RESPONSIBLE PROSPECTIVE CONTRACTORS--Table of Contents

 

Sec.  94.6  Remedies.



    (a) If the failure of an Investigator to comply with the conflict of 

interest policy of the Institution has biased the design, conduct, or 

reporting of the PHS-funded research, the Institution must promptly 

notify the PHS Awarding Component of the corrective action taken or to 

be taken. The PHS Awarding Component will consider the situation and, as 

necessary, take appropriate action or refer the matter to the 

institution for further action, which may include directions to the 

Institution on how to maintain appropriate objectivity in the funded 

project.

    (b) The HHS may at any time inquire into the Institutional 

procedures and actions regarding conflicting financial interests in PHS-

funded research, including a review of all records pertinent to 

compliance with this part. HHS may require submission of the records or 

review them on site. To the extent permitted by law HHS will maintain 

the confidentiality of all records of financial interests. On the basis 

of its review of records and/or other information that may be available, 

the PHS Awarding Component may decide that a particular conflict of 

interest will bias the objectivity of the PHS-funded research to such an 

extent that further corrective action is needed or that the Institution 

has not managed, reduced, or eliminated the conflict of interest in 

accordance with this part. The issuance of a Stop Work Order by the 

Contracting Officer may be necessary until the matter is resolved.

    (c) In any case in which the HHS determines that a PHS-funded 

project of clinical research whose purpose is to evaluate the safety or 

effectiveness of a drug, medical device, or treatment has been designed, 

conducted, or reported by an Investigator with a conflicting interest 

that was not disclosed or managed as required by this part, the 

Institution must require disclosure of the conflicting interest in each 

public presentation of the results of the research.



[60 FR 35817, July 11, 1995; 60 FR 39077, July 31, 1995]