Transcript Annual COI Disclosures

Conflict of Interest Office
Conflict of Interest
Office
A partner in promoting integrity in
research, teaching, and administration
Annual COI Disclosures
Khrys X. Myrddin, MPPM, Associate Director
Benjamin T. West, Compliance Coordinator
University of Pittsburgh
Conflict of Interest Office
Today’s Topics
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Definitions
Annual COI Filing Season
University of Pittsburgh COI Disclosure Forms
COI Training Requirements
PHS Update
Definitions - Investigator
 Any individual, regardless of title or position, who
participates in the design, conduct, or reporting of
research
 Based on individual’s role in the research
 Includes faculty, staff, and students
Agencies of the Public Health Service
(PHS)
 Administration for Children and Families (ACF)
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 Administration on Children, Youth and Families (ACYF)
Administration for Community Living (ACL)
Agency for Healthcare Research and Quality (AHRQ)
Centers for Disease Control and Prevention (CDC)
Centers for Medicare & Medicaid Services (CMS)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
 National Institutes of Health (NIH)
 National Cancer Institute
 Substance Abuse and Mental Health Services Administration
(SAMHSA)
Definitions – “PHS-funded
Investigator”
 The PI, project director, and any other person,
regardless of title or position, who is responsible for
the design, conduct, or reporting of research that is
funded in whole or in part by any agency of the PHS,
including collaborators and consultants.
 Based on individual’s role in the research
 Covers all persons (faculty, staff, and students) engaged
in the project, not just those listed on the grant/contract
Definitions –
Significant Financial Interest (SFI)
 A financial interest that reasonably appears to be
related to the Investigator’s Institutional
Responsibilities
 Different reporting thresholds for PHS-funded projects
 Questions on regular and PHS Faculty/Researcher COI
forms reflect the definition thresholds
 COI questions on IRB and IACUC protocols ask about
such interests related to the particular project
Definitions –
Institutional Responsibilities
 An Investigator’s professional responsibilities on
behalf of the University of Pittsburgh, including
activities such as
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research
teaching
professional practice
institutional committee memberships
service on panels such as IRBs or DSMBs
other administrative activities
Definitions – SFI (cont.)
 Equity in a publicly-traded entity that exceeds
$10,000 in value or 5%
 Any amount of equity in a non-publicly traded entity
 Remuneration from an entity that exceeds $10,000 in
a 12 month period (excl. non-profit & gov’t agencies)
 Being the author or inventor of a technology that has
been patented, copyrighted, or optioned/licensed to
an external entity, and on which evaluative or
developmental research is continuing;
Definitions – PHS SFI
 Aggregated remuneration from and equity in any publicly
traded entity exceeding $5,000 in value or an equity
interest that exceeds 5% in such an entity;
 Remuneration from a non-publicly traded entity (including
nonprofit entities except Exempt Institutions) in a 12
month period exceeding $5,000, or any equity interest in
such an entity;
 Reimbursed or sponsored travel expenses related to
Institutional Responsibilities from a single entity (except
Exempt Institutions) that exceeds $5,000 in 12-months
Definitions – Exempt Institutions
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A federal, state, or local government agency;
A domestic Institution of Higher Education;
An academic teaching hospital;
A medical center; or
A research institute that is affiliated with an
Institution of higher education
Definitions –
Financial Conflict of Interest (FCOI)
 A Significant Financial Interest related to a research
project that could directly and significantly affect the
design, conduct, or reporting of the research.
Annual COI Filing
 Everyone files between Jan 1st – April 15th
 Disclosures must be kept up-to-date throughout the
year
 Separate UPMC & Pitt COI systems
 University: Superform https://coi.hs.pitt.edu/
 UPMC: My Hub > Human Resources tab > COI
Annual COI Filing –
Faculty/Researcher forms
 All regular full-time faculty
 Anyone, regardless of title or position, who engages
in research at the University of Pittsburgh
 Anyone who is or expects to be an investigator on a
PHS-funded project must complete the PHS
Faculty/Researcher form, instead of the regular form
 Only complete the Faculty/Researcher form that applies
to you, not both
Annual COI Filing –
Faculty/Researcher forms
 Part-time and adjunct faculty members not engaged
in research and with no financial interests that would
give rise to potential or perceived conflicts of interest
with their University responsibilities do not need to
complete a form
 Unless instructed to do so by their department chair.
 Faculty on unpaid leave do not need to complete COI
disclosure forms until they return to the University
Annual COI Filing –
Designated Administrator/Staff form
 For identifying COIs related to purchasing
 Faculty who are in a position to make, direct, or
materially influence University business decisions
need to complete a Designated Administrator/Staff
form, regardless of whether or not they complete a
Faculty/Researcher form
 Anyone who has significant influence over the
selection of outside vendors or providers of services
(e.g., can approve a Directed/Sole Source form)
 All deans, department chairs, center directors
COI Training requirements
 NO PHS-funded research: ISER COI Module
 Must retake if completed before August 6, 2012
 CITI Training will also fulfill this requirement
 PHS-funded Investigators: CITI COI Training Module
 Office of Research checks for this prior to submitting
proposals to PHS agencies
 Access through http://www.coi.pitt.edu/COItraining.htm
 ISER training does NOT fulfill this requirement
PHS Updates
 Q4 – Reimbursed or Sponsored Travel now has $5,000
reporting threshold
 From a single organization in a 12 month period for a
single trip or series of trips
 Includes members of your immediate family/household
 New COI questions on PHS-funded IRB & IACUC
protocols
 COI questions removed from rDNA/IBC, CORID, &
hSCRO
QUESTIONS?
Information & Assistance
COI Website: http://www.coi.pitt.edu/
COI Office Staff
David T. Wehrle: [email protected]; 412-383-1774
Khrys X. Myrddin: [email protected]; 412-383-2828
Benjamin T. West: [email protected]; 412-383-1735
COIC Chair
Jerome L. Rosenberg: [email protected]; 412-624-3007