Post on 30-Mar-2015
Conflict of Interest Office
Conflict of Interest Office
A partner in promoting integrity in research, teaching, and
administration
http://www.coi.pitt.edu/
Annual COI DisclosuresKhrys X. Myrddin, MPPM, Associate DirectorBenjamin T. West, Compliance Coordinator
University of PittsburghConflict of Interest Office
Definitions Annual COI Filing Season University of Pittsburgh COI Disclosure Forms COI Training Requirements PHS Update
Today’s Topics
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
Definitions - Investigator
Administration for Children and Families (ACF) 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)
Agencies of the Public Health Service (PHS)
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 – “PHS-funded Investigator”
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 – Significant Financial Interest (SFI)
An Investigator’s professional responsibilities on behalf of the University of Pittsburgh, including activities such as research teaching professional practice institutional committee memberships service on panels such as IRBs or DSMBs other administrative activities
Definitions – Institutional Responsibilities
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 – SFI (cont.)
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 – PHS SFI
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 – Exempt Institutions
A Significant Financial Interest related to a research project that could directly and significantly affect the design, conduct, or reporting of the research.
Definitions – Financial Conflict of Interest (FCOI)
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
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 – Faculty/Researcher forms
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
Annual COI Filing – Designated Administrator/Staff form
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
COI Training requirements
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
PHS Updates
QUESTIONS?
COI Website: http://www.coi.pitt.edu/
COI Office StaffDavid T. Wehrle: wehrledt@upmc.edu; 412-383-1774Khrys X. Myrddin: myrddink@upmc.edu; 412-383-2828Benjamin T. West: westbt@upmc.edu; 412-383-1735
COIC ChairJerome L. Rosenberg: jrosenb@pitt.edu; 412-624-3007
Information & Assistance