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