[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR50.606]

[Page 154-155]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 50_POLICIES OF GENERAL APPLICABILITY--Table of Contents
 
  Subpart F_Responsibility of Applicants for Promoting Objectivity in 
                Research for Which PHS Funding Is Sought
 
Sec. 50.606  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 requirement for submission of, or review on 
site, all records pertinent to compliance with this subpart. 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 subpart. The PHS Awarding Component may determine that 
suspension of funding under 45 CFR 74.62 is 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

[[Page 155]]

has been designed, conducted, or reported by an Investigator with a 
conflicting interest that was not disclosed or managed as required by 
this subpart, the Institution must require the Investigator(s) involved 
to disclose the conflicting interest in each public presentation of the 
results of the research.