[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2006]

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

[CITE: 42CFR50.606]



[Page 150-151]

 

                         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 151]]



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.