[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: 45CFR94.6]

[Page 469]
 
                        TITLE 45--PUBLIC WELFARE
 
                           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]