Transcript Document

University of Pittsburgh
Conflict of Interest Office
A Partner in Promoting Integrity in Research, Teaching, and Administration
NEW REVISED CONFLICT OF
INTEREST POLICY, USING
THE SUPERFORM, &
FINANCIAL COI
MANAGEMENT
COI Office
David Wehrle, Director
Khrys Myrddin, Associate Director
October 13, 2010
What is a Conflict of Interest?

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.
Examples of Potential Conflicts

Example 1
 Professor
Maureen Belstein, faculty
member/researcher
 Consultant/speaker 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
Examples of Potential Conflicts
(cont’d)

Example 2
 Dr.
William Monardo, faculty member/
researcher
 President/owner of Laboratory
Solutions, Inc. (LSI)
 Dr. Monardo’s research group
purchases scientific supplies and
equipment from LSI.
Examples of Potential Conflicts
(cont’d)

Example 3
 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.
Examples of Potential Conflicts
(cont’d)

Example 4
 Dr.
K. C. Stengel developed a new method
for collecting adult stem cells, which was
patented by the University; she receives
royalties for this IP through Pitt
 The technology is licensed to Cell
Colonies, Inc., a non-public company
 She holds equity in the company
 Dr. Stengel is conducting federally
sponsored research to further evaluate the
technology.
Importance of COI Management
If COI is not managed…
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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;
Importance of COI Management
(cont’d)
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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 may result;
scandals or negative media attention may
occur….
THE CHRONICLE
of Higher Education
Baylor College of Medicine Faces NIH
Sanctions Over Financial Conflicts
Paul Baskin  Tuesday, January 20, 2010
The NIH has ordered tougher financial disclosures on all grant
applications from Baylor College of Medicine, [citing] ”serious
concerns” about the college’s compliance with regulations
governing conflicts of interest….
The doctors who spoke favorably of Vytorin® included Christie M.
Ballantyne…who collected $34,472 during a five-month
period…
The NIH informed the institution last month that the agency would
impose ‘special award conditions” on all future grants.
Today’s topics
New University COI Policy
 Departmental responsibilities

 Annual
COI filing process
 Using the Superform system
 COI Oversight & Management
Today’s topics (cont’d)

University-level COI Management
 Research
protocols
 Entrepreneurial endeavors
 Purchasing
 Office of Research
Policy 11-01-03

COI Policy for Faculty, Scholars,
Researchers, Research Staff/Coordinators

http://www.bc.pitt.edu/policies/policy/11/11-01-03.html
List of changes and policy flow charts are also available
from the COI website:
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
http://www.coi.pitt.edu/Policies/index.htm
Rationale for a Conflict of Interest
(COI) Policy
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Our COI Policy reaffirms the value of
faculty members interactions with the
commercial sector and provides guidelines
for maintaining integrity in research in the
course of such interactions.
How rev. COI policy 11-01-03 differs
from previous version
Policy 11-02-03 Commercialization of Inventions
Through Independent Companies merged into 11-0103
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Eliminates the “Entrepreneurial Oversight Committee” as a
separate entity; duties assumed by COIC
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“EOC Companies”  Licensed Start-Up Companies
Elimination of the 1% of salary threshold for disclosing
outside remuneration
Definition of a zero-threshold for individually-held
equity in determining a Significant Financial Interest
(SFI) in any non-public company
How rev. COI policy differs from
previous version (cont’d)
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Codification of “Working COI Policies” and procedures
for protocols overseen by regulatory committees (IRB,
IACUC, etc.)
Explicit statement of the PI exclusion rule for
specifically regulated research
Explicit rules governing exemptions from the PI
exclusion rule
How rev. COI policy differs from
previous version (cont’d)
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Inclusion of a community member on COI Committee
and on a data stewardship committee for a project
sponsored by a company in which the University holds
equity and a conflicted investigator is allowed to be PI
Increase in the equity cap in Licensed Start-up
Companies from 20% to up to 49%
Assuming his/her department chair does not object, a
researcher conflicted with a Licensed Start-up
Company can be PI on the University’s portion of an
SBIR or STTR grant not involving human subjects or
animals, subject to implementation of appropriate COI
management plan.
Annual COI Filing Process
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University Policies
 11-01-03
 07-05-02 (COI – Designated Administrators and Staff)
Annual COI memo from the provost & executive vice
chancellor
Annual COI Filing Process:
Who?

Faculty/Researcher Form
 All
individuals with regular faculty
appointments
 Employees of any classification who “direct or
can materially influence research, or who are
responsible for the design, conduct, and
reporting of research”
Annual COI Filing Process:
Who? (cont’d)

Designated Administrator/Staff form
 Employees
classified as Administrator IV or
above, and those of other classifications
(including faculty) 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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Deans, department chairs, division chiefs, and center
directors with faculty appointments must complete both
University forms.
Reporting Financial
Relationships: When?
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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
upon appointment
 by April 15 of each year
 whenever new outside interests are
accrued
 using the Superform system
https://coi.hs.pitt.edu
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What is the Superform
system?
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The electronic Superform system must be used to
file COI disclosures (there is no paper form).
All forms filed become part of a secure COI
database, accessible only to authorized
individuals.
The Superform system includes reporting forms
for only the University of Pittsburgh.
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UPMC uses a separate system accessible through
Infonet http://compliance.infonet.upmc.com/COI.htm
Who Has Access to the COI
Database?
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IRB/IACUC/CORID
Purchasing
Office of Research
Internal Audit
General Counsel
COI Office
COI Committee Chair
Regional Campus Presidents/Deans/
Department Chairs
Research administrators/coordinators
Who Has Access to the COI
Database? (cont’d)
Research administrators can determine
whether investigators have a current COI
form on file
 Request access through the COI Office
(requires name, HSConnect username,
departmental affiliation, and level of
access to be granted. i.e., basic or
operational
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Send request to [email protected]
Making disclosures—Using
the Superform system
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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
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an HSConnect account
If no links to forms appear on Welcome
screen, add University affiliation to
profile
Making disclosures—Using the
Superform system (cont’d)
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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
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Edit responses as applicable
Review the Form Summary
Click “Submit this form”
Click “View and Print” next to the form you
wish to print
Print and sign Signature Page (SP)
Making disclosures—Using the
Superform system (cont’d)
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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COI Oversight by Supervisors
Faculty/Researcher—Department Level
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Department Chairs review
Faculty/Researcher disclosures
 Ensure
that all required employees have
signed and submitted the Signature Page by
April 15
COI Oversight by Supervisors
Faculty/Researcher—Department Level (cont’d)

Prepare Management Reporting Forms
(MRF) for individuals who disclosed outside
interests
 Section E: Is disclosure alone of the
individual’s potential conflict in abstracts,
publications, presentations, press
releases, and in proposals and
applications for research funding
sufficient to manage the conflict?

Answer Yes, if an individual's outside
activities create no conflict with his/her
University work, i.e., s/he is not conducting
research of commercial interest to any
company or making purchases from any
company with which s/he has a relationship
COI Oversight by Supervisors
Faculty/Researcher—Department Level (cont’d)
 Answer
No if any relationship requires COI
management above and beyond disclosure; describe
actions taken; e.g., SMP has been invoked for a
clinical trial; a data monitoring committee was
established for the individual’s research program;
entrepreneurial activities are being overseen by the
COI Committee, etc.
COI Oversight by Supervisors
Faculty/Researcher—Department Level
(cont’d)
Prepare departmental Annual Data
Summary report
 Submit Signature Pages, related
MRFs, and department’s Annual Data
Summary Report to dean for review
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SPs on which no outside interests were
disclosed do not need to be submitted to
the dean
COI Oversight by Supervisors
Faculty/Researcher—Dean’s Level
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Dean reviews forms received from
chairs
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Approves or modifies any MRFs, as
necessary
Prepares School’s Annual Data
Summary Report
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Submit Signature Pages, related MRFs,
and Departments’ and School’s Annual
Data Summary Reports to the provost
or senior vice chancellor for the health
sciences by May 15
COI Oversight by Supervisors
Designated Administrators/Staff—Department Level

Supervisor reviews Designated Administrators/Staff
disclosures
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Ensures that all required employees have signed
and submitted the SP by April 15
The supervisor should work with the employee to
develop a plan to manage any potential COI and
document it in the form of a memorandum (do not
use the MRF)
NEW -- Prepares an Annual Data Summary Report
and submits it to the next higher reporting authority
within the responsibility center
COI Oversight by Supervisors
Designated Administrators/Staff—Department Level
 Report
unresolved conflicts to the provost,
senior vice chancellor for the health sciences, or
executive vice chancellor by May 15;
 SPs and management plans of resolved conflicts
need not be forwarded, and should be filed in
department
COI Oversight
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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Departmental COI Management

Prospective approval from department chair or
dean is required for
 Consultancies,
speaking engagements, and
membership on scientific advisory boards
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cannot use University facilities or resources
total time expenditures in all outside professional
activities cannot exceed one day per week

Note: staff members must conduct all outside activities on
their own time
 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
Departmental COI Management
(cont’d)

Department Chairs are responsible for the
development of COI management plans
for research not overseen by a regulatory
committee
Departmental COI Management
(cont’d)
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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
Proper use of students/staff by faculty
members with outside interests
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Prospective review and approval of
activities by department chair or dean
Formal notification of faculty members’
interest in an outside company
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Faculty members should distribute
Student/Staff Notification Form for signature
by students/staff
Students/staff should discuss any concerns
with faculty members’ non-conflicted
supervisor and/or COI Committee
Proper use of students/staff by faculty
members with outside interests (cont’d)
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Work under approved Corporate Research
Agreement (CRA) should correspond to effort
provided for in the CRA (e.g., no overtime)
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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
Proper use of students/staff by faculty
members with outside interests (cont’d)
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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
Students/staff cannot perform work on University time
or use University resources related to a faculty
member’s outside professional activities (e.g., providing
administrative assistance with faculty’s outside
consulting activities)
Proper use of students/staff by faculty
members with outside interests (cont’d)
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Reporting of troublesome COI issues by
students/staff
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to department chair, dean, school’s representative in
the Graduate and Professional Student Assembly
and/or the Conflict of Interest Committee, or
AlertLine, 1-866-858-4456: anonymous, 24 hours a
day, accessible from any North American telephone.
University-level COI Management—
Research Protocols

The COIC is responsible for
managing potential conflicts involving
the following:
 Human subject research (IRB)
 Animal research (IACUC)
 Research
and Clinical Training on
Decedents (CORID)
 Recombinant DNA research (IBC)
 Human stem cell research (hSCRO)
University-level COI Management—
Research Protocols (cont’d)
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COI questions that appear on protocol
applications apply to all investigators and
research personnel
PI is responsible for ensuring that all
investigators and study personnel review these
questions
Reporting must be kept current
 Whenever
new outside interests are accrued,
investigators should notify the COI Office and the
appropriate regulatory committee (e.g., IRB, IACUC,
etc.), and update their Faculty/Researcher forms.
COI Questions on Protocols

Does the principal investigator or any co-investigator or
research coordinator involved in this study (or in
aggregate with his/her spouse, dependents or other
members of his/her household):
a.
b.
possess an equity interest in the publicly-traded entity that
either sponsors this research or owns the technology being
evaluated that exceeds 5% ownership interest or a current
value of $10,000?
possess any equity interest in the non-publicly-traded entity
that either sponsors this research or owns the technology
being evaluated?
COI Questions on Protocols
(cont’d)
c)
d)
e)
receive salary, consulting fees, honoraria, royalties
or other payments from the entity that either
sponsors this research or owns the technology
being evaluated that is expected to exceed $10,000
in any twelve-month period?
have rights to the intellectual property (IP) being
evaluated, as either the inventor of the IP for which
a patent has been issued, or as the inventor of the
IP that has been optioned or licensed to a
company?
have a financial relationship with a Licensed Startup Company (which is being monitored by the COI
Committee) that has an option or license to utilize
the technology being evaluated?
COI Questions on Protocols
(cont’d)

f.
IRB only
Receive compensation of any amount when
the value of the compensation would be
affected by the outcome of the research,
such as compensation that is explicitly
greater for a favorable outcome than for an
unfavorable outcome or compensation in the
form of an equity interest in the entity that
either sponsors this research or owns the
technology being evaluated.
University COI Management—Research
Protocols (cont’d)

Answering “Yes” to any of the COI
questions on the IRB protocol requires use
of the Standard COI Management Plan
(SMP) for Human Subject Research
 Available
in OSIRIS or from the COI Office Web site:
http://www.coi.pitt.edu/Forms/StandardCOIMgmtPlanHSR.htm
University COI Management—
Research Protocols

For IACUC, CORID, and hSCRO,
investigator cannot be PI if s/he
answers “Yes” to the questions asking
about equity, remuneration, or a
relationship with a Licensed Start-up
company.
 Management
plan similar to SMP, less the
items specific to HSR
 IBC did not adopt the PI-exclusion rule;
reviewed on a case-by-case basis

Financial relationships only in the IP
being evaluated are reviewed on a
case-by-case basis.
University-level COI Management—
Licensed Start-up Companies

The COI Committee is responsible for
managing potential conflicts involving
Licensed Start-up Companies (i.e., not
publicly traded)
 that
have an option or license to University
intellectual property
 in which equity (including stock options) is
held by University employees or students,
members of their immediate families, or by the
University

Special restrictions on relationships with
these companies
University-level COI
Management—Purchasing

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University Purchasing Services refers issues
to the COI Office for review; e.g., if the
requestor or approver of a Directed/Sole
Source form has a financial relationship with
the company from which a purchase is being
requested
Purchasing Services reports quarterly to the
COIC on purchases made from companies in
which University employees have a financial
interest
University-level COI Management—
Office of Research
University must attest that the PI of a
grant has a current COI disclosure on file;
grants administrators query COI database
 Contracts officers query the database to
see whether PI or other investigators
have disclosed a relationship with an
industry sponsor
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 If
yes, referred to COI Office for review &
management
Additional Help with COI
Management

Conflict of Interest Office

COI Office Web site www.coi.pitt.edu
 includes sample management plans,
case studies, 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
Questions?
Contacts/Assistance

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
Associate Director/COI Office
412-383-2828 [email protected]

Hannelore N. Rogers, MA
Coordinator/COI Office
412-383-1968 [email protected]
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COI Web site: www.coi.pitt.edu