[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