[Federal Register Volume 61, Number 214 (Monday, November 4, 1996)]
[Rules and Regulations]
[Pages 56631-56632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: X96-21104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Public Health Service

42 CFR Part 50

Policies of General Applicability

CFR Correction

    In title 42 of the Code of Federal Regulations, parts 1 to 399, 
revised as of October 1, 1995, page 171, Sec. Sec. 50.604 through 
50.606 are added as follows:


Sec. 50.604  Institutional responsibility regarding conflicting 
interests of investigators.

    Each Institution must:
    (a) Maintain an appropriate written, enforced policy on conflict of 
interest

[[Page 56632]]

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:
    (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.


Sec. 50.605  Management of conflicting interests.

    (a) The designated official(s) must: Review all financial 
disclosures; and determine whether a conflict of interest exists and, 
if so, determine what actions should be taken by the institution to 
manage, reduce or eliminate such conflict of interest. A conflict of 
interest exists when the designated official(s) reasonably determines 
that a Significant Financial Interest could directly and significantly 
affect the design, conduct, or reporting of the PHS-funded research. 
Examples of conditions or restrictions that might be imposed to manage 
conflicts of interest include, but are not limited to:
    (1) Public disclosure of significant financial interests;
    (2) Monitoring of research by independent reviewers;
    (3) Modification of the research plan;
    (4) Disqualification from participation in all or a portion of the 
research funded by the PHS;
    (5) Divestiture of significant financial interests; or
    (6) Severance of relationships that create actual or potential 
conflicts.
    (b) In addition to the types of conflicting financial interests 
described in this paragraph that must be managed, reduced, or 
eliminated, an Institution may require the management of other 
conflicting financial interests, as the Institution deems appropriate.


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 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.

BILLING CODE 1505-01-D