Transcript Conflict of Interest & PHS Regulations for School of

Presented by
Jerome L. Rosenberg, PhD/Chair of the COI Committee &
David T. Wehrle, CPA, CIA, CFE/Director of the COI Office
September 10, 2012
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Effective August 24, 2012
The University of Pittsburgh’s
Policy 11-01-03 Conflict of Interest for
Faculty, Researchers, Scholars, Research
Staff/Coordinators reflects revised PHS
regulations
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COI training
◦ Investigators currently engaged, or who anticipate
engaging in PHS-supported research in the coming
year, must complete the CITI (Collaborative
Institutional Training Institute) COI Training Module
as soon as possible, and before the University can
submit a proposal to any PHS agency on which they
are listed.
◦ PHS-funded researchers are required to complete
the CITI COI Training Module every three years
thereafter.
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COI training
cont’d
◦ Investigators who do not work on any PHS-funded
projects and who:
 submit a proposal through the Office of Research for
funding from a non-PHS source; or
 disclosed outside financial interests on the University’s
Faculty/Researcher form; or
 have been directed by their department chairs or deans to
complete COI training
◦ must complete either the CITI COI Training Module
or the Internet-based Studies in Education and
Research (ISER) Conflict of Interest Module
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New disclosure requirements: investigators must
disclose
◦ outside interests related to their institutional
responsibilities exceeding $5,000 (called Significant
Financial Interests – SFIs)
◦ income from non-exempt not-for-profit organizations
◦ sponsored/reimbursed travel
◦ new SFIs within 30 days
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on the new PHS-specific Faculty/Researcher COI
form using the Superform system at
https://coi.hs.pitt.edu. This form must be
completed as soon as possible and before the
University can submit a proposal to any PHS
agency on which they are listed.
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Comparing disclosure requirements
◦ Previously:
 Investigators disclosed/determined whether their
outside interests gave rise to potential conflicts with
their research.
◦ Now:
 Investigators disclose SFIs related to their institutional
responsibilities, and the institution (i.e., supervisors
and/or the Conflict of Interest Committee) determines
whether they give rise to Financial Conflicts of Interest
(FCOIs) with PHS-funded research requiring
management.
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Review PHS-specific Faculty/Researcher COI
form;
Complete a PHS-specific Management
Reporting Form (MRF):
 determine whether an SFI in the $5,001-$10,000
range gives rise to an FCOI (i.e., the SFI is related to
the PHS-funded research and could directly and
significantly affect the design, conduct, or reporting of
such research);
 if it does not, explain why; or
 state that there is an FCOI, indicate how it will be
managed, and send a copy of the COI form and MRF to the
COI Office
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If an FCOI has been identified, the conflict management
plan (CMP) must include at least the following elements:
◦ Investigator must disclose SFI in abstracts, presentations, press
releases, publications resulting from PHS-funded research and in
proposals/applications for research funding involving matters of
commercial interest to the entity in which the investigator has an SFI
◦ Other students, staff, faculty engaged in the research must be notified
of the Investigator’s SFI through the use of a standard notification
form
◦ Students must have approval of their department chair or dean to be
engaged in project
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Other optional management techniques: data steward or
oversight committee; prohibiting individual from serving
as PI, or other limits on his or her role in the research
project.
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The COIC, in consultation with department
chairs and investigators, will review SFIs
greater than $10,000 to determine whether
they constitute FCOIs with PHS-funded
research.
If they do, the COIC will manage the FCOIs.
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Supervisors must monitor Investigators’
compliance with management plans on an
ongoing basis until completion of the
projects, and, for FCOIs, provide the chair of
the COI Committee with their plans for
monitoring compliance.
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In keeping with the PHS’s requirements for
greater transparency, before the Institution
expends funds on a PHS-funded project, it
must publicly post on its COI Web site the
following information concerning FCOIs held
by the investigator:
◦ Name, title, and role of investigator on the research
project
◦ Name of entity in which interest is held
◦ Nature of the SFI
◦ Approximate dollar value of SFI within a defined set
of ranges, where possible
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If identification or management of an FCOI
was delayed, or the Investigator failed to
comply with a plan to manage his or her
FCOI, the COIC must complete a retrospective
review to determine whether any PHS-funded
research was biased in the design, conduct,
or reporting of such research performed
during the period of non-compliance.
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COI Web site: http://www.coi.pitt.edu/
Policy 11-01-03:
◦ http://cfo.pitt.edu/policies/documents/policy11-01-03.pdf
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Jerome L. Rosenberg: [email protected]; 412-624-3007
David T. Wehrle: [email protected]; 412-383-1774
Khrys X. Myrddin (Associate Director/COI Office):
[email protected]; 412-383-2828
Benjamin T. West (Compliance Coordinator/COI Office):
[email protected]: 412-383-1735
Hannelore N. Rogers (Coordinator/COI Office):
[email protected]; 412-383-1968
DHHS Financial Conflict of Interest Web page:
http://grants.nih.gov/grants/policy/coi/