Transcript Today’s topics - Conflict of Interest Office

University of Pittsburgh
Conflict of Interest Office
A Partner in Promoting Integrity in Research, Teaching, and
Administration
FACULTY/STAFF
DEVELOPMENT PROGRAM
COI Office:
Khrys Myrddin, Associate Director
Benjamin West, Senior Compliance Coordinator
Lisa Schoon, Compliance Coordinator
March 25, 2015
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A potential Conflict of Interest may exist if an
individual’s outside interests (especially financial)
may affect, or perceive to affect, his/her
research, teaching, or administrative activities at
the University.
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Example 1
◦ Professor Maureen Belstein, faculty
member/researcher
◦ Serves on Scientific Advisory Board for National Tool
Company (she earned $35,000 last year)
◦ NTC wants to sponsor university research to evaluate
new technologies
◦ Professor Belstein wants to be PI on the study
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Example 2
◦ The University was awarded a federal grant on which Dr. Ari
Samuel serves as PI.
◦ He subcontracted a portion of the work to Scanware for
installation of eye-movement analysis software.
◦ Dr. Samuel has an equity interest in this vendor.
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Example 3
◦ Dr. Maryann Ruecken developed a back
brace, which was patented by the University
◦ The technology is licensed to Strait &
Narrow, Inc., a non-publicly held company;
she receives royalties for the device through
Pitt
◦ She holds equity in the company
◦ Dr. Ruecken is conducting federally
sponsored research to further evaluate the
technology
If COI is not managed…
 protection of human subjects may be
compromised;
 integrity of research may be at risk;
 the public may lose trust in the University
and its research findings;
 the investigator/faculty member may lose
the respect of the academic community;
 violation of scientific norms may result;
 University may lose public support and
funding for research;
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research results may be excessively delayed
or not published;
there may be a negative impact on students;
University resources may be improperly
used;
increased government regulations;
scandals or negative media attention may
occur.
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Departmental responsibilities
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Annual COI filing process
Using the Superform system
Using the Pitt/UPMC Joint COI questionnaire
COI Oversight & Management
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University-level COI Management
◦ Research protocols
◦ Entrepreneurial endeavors
◦ Purchasing
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Annual COI memo from the provost & executive
vice chancellor – February 18th
University Policies
◦ 07-05-02
◦ 11-01-03
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Faculty/Researcher Forms (“Regular” & PHS-funded)
◦ All full-time faculty members
◦ Others of any classification (including staff & students) who
“direct or can materially influence research, or who are
responsible for the design, conduct, and reporting of research”
◦ Part-time faculty members not conducting research are covered
by this COI policy only to the extent that their outside financial
interests would reasonably appear to be affected by their work
for the University
◦ The policy does not apply to employees on unpaid leave from
the University or to adjunct faculty not conducting research
◦ “Regular” Faculty/ Researcher Form: all faculty members, as
well as others in any position, including students and staff,
who direct or can materially influence research, or who are
responsible for the design, conduct, and reporting of research
that is not funded by an agency of the Public Health Service
(PHS)
◦ PHS Faculty/Researcher Form: anyone participating in the
design, conduct, or reporting of any research funded by
any agency of the Public Health Service, such as NIH,
AHRQ, FDA, CDC, must complete this form
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Designated Administrator/Staff Form
◦ Deans, department chairs, division chiefs, and center
directors
◦ Employees classified as Administrator IV or above
◦ Those of other classifications who are in a position to
make, direct, or materially influence University business
decisions (e.g., employees who have significant influence
over the selection of outside vendors or providers of
services)
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Institutional Policies
◦ Policies 11-01-03 and 07-05-02 require reporting of the
outside interests of faculty, administrators, and
investigators
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upon appointment
by April 15 of each year
whenever new outside interests are accrued
electronically using the Superform system
https://coi.hs.pitt.edu directly or by completing the Pitt/UPMC
Joint COI questionnaire in MyHub
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COI disclosures must be filed electronically (there
are no paper forms).
All forms filed become part of a secure COI
database, accessible only to authorized
individuals.
The Superform system includes reporting forms
for the University of Pittsburgh only.
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University faculty with appointments at UPMC/UPP
should use the Pitt/UPMC Joint COI questionnaire in
My HUB to fulfill their UPMC and Pitt COI reporting
requirements
Data entered in the My HUB questionnaire is
transferred to Pitt’s COI database and used to
generate University COI disclosure forms in the
Superform system
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IRB/IACUC
Purchasing
Office of Research
Internal Audit
General Counsel
COI Office
COI Committee Chair
Regional Campus Presidents/Deans/ Department
Chairs
Research administrators/coordinators
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Request access through the COI Office (provide name,
HSConnect username, departmental affiliation, and level of
access to be granted, i.e., Basic or Operational)
◦ Send request for access to Lisa at [email protected]
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Research administrators with Basic access can determine
whether investigators have a current COI form on file
Operational access allows administrator to see details of
financial disclosures
◦ Must be approved by department chair
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Returning users:
◦ Login using existing HSConnect account
◦ Retrieve forgotten password
 Do not create a new account!
◦ Update HSConnect profile
◦ Change e-mail address/password
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New users:
◦ Create an HSConnect account
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If links to forms do not appear on Welcome screen,
confirm correct affiliation in profile
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Select the form you wish to complete
◦ First-time users must answer every question
◦ Returning users will be taken to the Form Summary page
 Edit responses as applicable
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Review the Form Summary
Click “Submit this form”
Click “View and Print” (next to the form you wish
to print)
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Print and sign Signature Page (SP);
Forward Faculty/Researcher SP to department
chair for review and signature;
Forward Admin/Staff SP to the next higher
administrator (who is at least at the level of
director or department chair) for review and
signature.
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To access the UPMC COI system, log into My HUB,
select the Human Resources tab and click the COI link
under My Profile;
Select “UPMC Pitt Joint Form,” and then answer the
subsequent questions to indicate which University
forms to complete
◦ “Regular” OR PHS Faculty/Researcher form
◦ Designated Administrator/Staff form, if applicable
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After submitting their answers, users will be prompted
to log into the Superform system with their
HSConnect username and password and taken to the
“Filing History” tab where the newly-created form(s)
are highlighted in green.
◦ Print the form to sign and submit to supervisor.
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For assistance:
◦ Check My HUB Frequently Asked Questions
◦ ISD Help Desk at 412-647-HELP (4357)
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Faculty/Researcher—Department Level
◦ Ensure that all required individuals have signed and
submitted a Signature Page by April 15
◦ Department Chairs & Directors review Faculty/ Researcher
forms received;
◦ Prepare Management Reporting Form (MRF) for each
individual who disclosed outside interests, identifying COIs
and explaining how they were managed.
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Management Reporting Form (MRF)
◦ Used to document all actions that have been taken to
manage identified conflicts of interest.
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Instructions for completing MRF
◦ Do not re-enter detailed responses from
Faculty/Researcher Form
◦ Enter only the category of financial interest (e.g.,
ownership interests, offices & positions, remunerative
activities, outside employment of students/staff,
technology transfer activities, etc.)
◦ Briefly describe all actions taken/or that will be taken to
manage any COIs between an individual’s responsibilities
at Pitt and his/her outside financial interests.
◦ If no management is needed, provide a justification (e.g.,
individual does not conduct research sponsored by, or of
commercial interest to, the company; individual makes no
purchasing decisions, etc.)
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Complete departmental Annual Data Summary
Report
Submit only Signature Pages disclosing outside
interests, the related signed MRFs, and
department’s Annual Data Summary Report to
dean or regional campus president for review
◦ Keep Signature Pages with no reported outside interests
on file in unit for seven years.
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Dean/Regional campus president
reviews forms received from chairs/directors
o Approves or modifies MRFs, as necessary
prepares the unit’s (e.g., school or regional campus)
Annual Data Summary Report for Faculty/Researcher
COI Forms
submits departmental Annual Data Summary Reports,
Signature Pages, MRFs received from all departments
in unit and the unit’s Annual Data Summary Report to
the provost or senior vice chancellor for the health
sciences
due by May 15th
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Ensure all required employees have signed and submitted
Signature Pages by April 15th
Review printed Signature Pages received
Develop a COI management plan, as needed
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Document the plan and employee’s agreement to it in the form of a
memorandum (do not use the MRF); keep this on file in unit; do not
forward to next higher supervisor unless requested.
Prepare and submit an Annual Data Summary Report for
Designated Administrator/Staff COI Forms to the next higher
reporting authority within the responsibility center (list number
of disclosures submitted and number that disclosed outside
interests or activities).
Due May 15th
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Report unresolved conflicts to the provost, senior
vice chancellor for the health sciences, or executive
vice chancellor by May 15th
o Hint: there should be no unresolved conflicts
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Signature Pages and management plans of resolved
conflicts should not be forwarded, but should be
filed in the department
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Signature Pages, Management Reporting
Forms, and Annual Data Summary Reports are
ultimately forwarded to the COI Office by the
provost or senior vice chancellor for the health
sciences
Everything you need for the annual COI filing
process can be found at
http://www.coi.pitt.edu/directive.htm
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Prospective approval from department chair or dean is
required for:
◦ All outside professional activities (consultancies, speaking
engagements, scientific advisory boards);
◦ Involvement of students in outside entities or in research of interest to
a company in which a faculty member has a financial interest;
◦ Purchasing from, or subcontracting work to, a company in which an
individual has a financial interest.
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Cannot use University facilities or resources
Total time expenditures in all outside professional activities
cannot exceed one day per week on the average
 Note: staff members must conduct all outside activities on their own time
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Department chairs are responsible for the
development of COI management plans for research
not overseen by the IRB or IACUC.
◦ Chairs may contact the COI Office for assistance;
◦ COI Office appreciates receiving a copy of the
management plans for our records.
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Management Options
◦ Divestment or reduction of financial interest;
◦ Disclosure of COI in publications, presentations, press
releases, abstracts, and in proposals and applications for
research funding;
◦ Disclosure of potential COI to others involved in the
research;
◦ Dilution of investigator’s role in study, i.e., cannot be PI, but
may be co-investigator;
◦ Addition of a data steward to a particular research project;
◦ Establishment of an oversight committee.
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PHS COI Review
◦ The PHS COI regulations require the University to consider
whether disclosed SFIs valued above $5,000 could give rise to
a Financial Conflict of Interest (FCOI) with any PHS-funded
project in which the individual is engaged.
◦ Department chairs are responsible for FCOI determination for
SFIs between $5,000 -$10,000
 COIC will review and make final FCOI determination for SFIs
greater than $10,000.
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PHS COI Review – “Relatedness assessment”
o Supervisors must determine if an investigator’s SFI is related to
any PHS-funded projects on which the individual serves as an
investigator
1. Is the work being done under any of the PHS grants or contracts
evaluating or developing any of the company’s products or
intellectual property?
2. To your knowledge, are any of these PHS-funded research projects
evaluating or developing any product of a competitor of the
company?
3. Is the company providing funding or other support (e.g., drugs or
devices) for any of these PHS-funded projects?
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If the answer to any above question is yes, the
supervisor needs to determine if the SFI gives rise to
an FCOI
◦ i.e., could directly and significantly affect the design, conduct,
or reporting of the PHS-funded project.
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Management of FCOIs
◦ For FCOIs in the $5,000-$10,000 range, department chairs
will determine level of COI management;
◦ For FCOIs over $10,ooo centralized management proceeds as
normal.
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Prospective review and approval of activities by
students’ department chairs or deans
Formal notification of faculty members’ interest in
an outside company
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Faculty members should distribute Student/Staff
Notification Form (available on COI web site) for
signature by students/staff
Students/staff should discuss any concerns with faculty
members’ non-conflicted supervisor and/or COI Office
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Work under approved Corporate Research
Agreement (CRA) should correspond to effort
provided for in the CRA
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Cannot be compelled to perform work that will benefit
the company;
Compatibility with academic interests of students;
Timely ability to publish research results for academic
credit without hindrance by the company’s commercial
interests;
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Assurance that students’ intellectual property is
protected;
Employment of students at faculty member’s
company
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Salary must be commensurate with tasks performed.
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The Conflict of Interest Committee (COIC) is
responsible for managing potential conflicts
involving research overseen by the IRB and IACUC.
COI questions appear in all research protocol
applications and apply to all Investigators listed in
the protocol
Referred to COI Office for review & management
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Licensed Start-up Companies (LSCs)
◦ Are not publicly-traded
◦ Have an option or license to University intellectual
property
◦ University and/or University employees or students, or
members of their immediate families hold equity,
(including stock options)
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The COI Committee is responsible for managing
potential conflicts involving LSCs
Special restrictions on relationships with these
companies
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University Purchasing Services refers issues to the
COI Office for review
◦ E.g., if the individual completing a Directed/Sole Source
form has a financial relationship with the company from
which a purchase is being requested.
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Purchasing Services reports quarterly to the COI
Committee on purchases made from companies in
which University employees have a financial
interest.
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University must attest that the PI of a grant has a
current COI disclosure on file; grants administrators
query COI database to verify compliance;
Contract officers also query the database to
determine whether PI or other investigators have
disclosed a relationship with an Industry sponsor
◦ If yes, matter is referred to COI Office for review &
management
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Submission stage: Office of Research checks that PI/PD and
all Senior/Key personnel have current PHS Faculty/Researcher
forms on file & have completed the CITI PHS COI Training
module.
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Award stage: Office of Research checks COI PHS
Faculty/Researcher forms of key personnel for SFIs
◦ Positive responses referred to COI Office for review
 COI Office contacts Investigator to obtain supervisor’s review
 Depending on nature of SFI, supervisor review may be final, or COI
Committee will review
 If supervisor and/or COIC determines that there is no FCOI, COI
Office informs the Office of Research that funds can be released.
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If there is an FCOI, Investigator must agree to a
management plan before funds can be released
 COI Office reports managed FCOI to funding
agency
 As required by the PHS COI regulations, managed
FCOIs are posted on a publicly-accessible website:
 http://www.coi.pitt.edu/PHS/FCOIList.htm
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Conflict of Interest Office
COI website www.coi.pitt.edu
◦ includes oversight checklist for supervisors, COI-related
forms, and links to relevant policies, the Superform system,
and the annual COI memo from the provost and the executive
vice chancellor
◦ SOHS Industry Relationship Policy
Jerome L. Rosenberg, PhD
Chair/COI Committee
412-624-3007 [email protected]
David T. Wehrle, CPA, CFE, CIA
Director/COI Office
412-383-1774 [email protected]
Khrys X. Myrddin, MPPM
Associate Director/COI Office
412-383-2828 [email protected]
Benjamin T. West, BA
Senior Compliance Coordinator/COI Office
412-383-1735 [email protected]
Lisa M. Schoon, MPIA
Compliance Coordinator/COI Office
412-624-6737 [email protected]