[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

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.