[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR50.604]

[Page 149-150]
 
                         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. 50.604  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 subpart 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 subgrantees, contractors, or collaborators, the Institution must 
take reasonable steps to ensure that Investigators working for such 
entities comply with this subpart, 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 subpart.
    (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 subpart 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 
at least three years from the date of submission of the final 
expenditures report or, where applicable, from other dates specified in 
45 CFR 74.53(b) for different situations.
    (f) Establish adequate enforcement mechanisms and provide for 
sanctions where appropriate.
    (g) Certify, in each application for the funding to which this 
subpart applies, that:

[[Page 150]]

    (1) There is an 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 a 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 subpart; 
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 subpart.