Transcript F S D P W o r k s... University of Pittsburgh Conflict of Interest Office

FSDP Workshop
University of Pittsburgh
Conflict of Interest Office
A Partner in Promoting Integrity in Research, Teaching, and Administration
The WHYs & HOWs of
Financial Conflict of
Interest Management
COI Office
David Wehrle, Director
Khrys Myrddin, Associate Director
January 9, 2009
What is a Conflict of Interest?
 A potential Conflict of Interest (COI) 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
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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
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Dr. Maryann Ruecken developed a back brace which
was patented by the University; she receives
royalties for the device through Pitt
The technology is licensed to Strait & Narrow, Inc., a
non-publicly held company
She holds equity in the company
Dr. Ruecken is conducting federally sponsored
research to further evaluate the technology.
Importance of COI Management
Why is it important to identify and manage
conflicts of interests?
Importance of COI Management
(cont’d)
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
academic science;
Importance of COI Management
(cont’d)
 product or service may be inferior;
 price may be too high;
 may give actual or perceived improper preferential
treatment to vendors;
 may violate terms of research grants and contracts
(including failure to disclose COI) and federal
regulations.
Importance of COI Management
(cont’d)
 research results may be excessively delayed or not
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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….
FDA Halts Gene Experiments
at University of Pennsylvania
By Rick Weiss and Deborah Nelson
Washington Post Staff Writers
Saturday, January 22, 2000; Page A1
The federal government yesterday halted all human
gene therapy experiments involving a prominent
researcher at the University of Pennsylvania,
saying an investigation into the September death
of a teenager there found the school's prestigious
program in serious disarray.
ATLANTA JOURNAL CONSTITUTION
Depression expert at Emory pulls out of
research projects
NIH freezes grant money; Emory to begin monitoring potential
conflicts of interest
Gayle White, Craig Schneider  Tuesday, October 14, 2008
Emory psychiatry professor D. Charles B. Nemeroff is stepping down
from university research projects funded by the National Institutes
of Health, as the federal agency cracks down on the school’s
handling of potential conflicts of interest, university officials said.
The NIH has frozen funds for a $9.3 million project on depression led
by Nemeroff, acknowledged Ron Sauder, a university vice
president. The project had been under way for two of its proposed
five years.
NEW YORK TIMES
Researchers Fail to Reveal Full Drug Pay
By GARDINER HARRIS and BENEDICT CAREY June 8, 2008
A world-renowned Harvard child psychiatrist whose work has helped fuel
an explosion in the use of powerful antipsychotic medicines in children
earned at least $1.6 million in consulting fees from drug makers from
2000 to 2007 but for years did not report much of this income to
university officials, according to information given Congressional
investigators.
By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a
colleague in the psychiatry department at Harvard Medical School, Dr.
Timothy E. Wilens, may have violated federal and university research
rules designed to police potential conflicts of interest, according to
Senator Charles E. Grassley, Republican of Iowa. Some of their
research is financed by government grants.
Disclosure: Why?
 University Policies
11-01-03 (COI – Research/Teaching)
 07-05-02 (COI – Designated Administrators and
Staff)
 COI Committee Working COI Policies
 IRB
 IACUC
 CORID
 hSCRO
 Industry Relationship Policy (SOHS/UPMC)
 Annual COI memo from the provost & executive vice
chancellor (Directive to Disclose)

Note: a new COI Policy is scheduled to be implemented in 2009
Disclosure: Who?
 Faculty/Researchers
 Employees classified as Staff, who direct or
can materially influence research, or who are
responsible for the design, conduct, and
reporting of research
Disclosure: Who? (cont’d)
 Employees classified as Administrator IV or
above, and 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)
Reporting Financial Relationships
 Institutional Policies
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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
using the Superform system
https://coi.hs.pitt.edu
What is the Superform system?
 The Superform system includes reporting forms for
the University of Pittsburgh, the UPMC, and the
University of Pittsburgh Physicians.
 All forms filed become part of a secure COI
database, accessible only to authorized individuals.
Who Uses 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 Uses the COI Database? (cont’d)
 Research administrators can determine
whether investigators have a current COI
form on file by using the Administrative
Access Gateway
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Administrative access may be requested
through the COI Office (requires name, HS
Connect e-mail address & departmental
affiliation of individuals eligible to have access)
Using the Superform system
 Create an HSConnect account/use an
existing account
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Retrieve forgotten password
 Create/update your profile
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Describe University affiliation
Indicate which COI forms must be filed
 Change e-mail address/password
Using the Superform system (cont’d)
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Answer Part I Questions
Answer Part II Questions (as appropriate)
Review and file disclosure
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
COI Oversight by Supervisors
Faculty/Researcher—Department Level
 Department Level
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Review of Faculty/Researcher disclosures
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Ensure that all required employees have
submitted and signed the Signature Page (SP) by
April 15
COI Oversight by Supervisors
Faculty/Researcher—Department Level (cont’d)
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Prepare a Management Reporting Form (MRF) or
electronic MRF (eMRF) for those individuals who
disclosed outside interests
Prepare departmental Annual Data Summary
report on disclosures submitted
Submit Signature Pages, related MRFs, and
department’s Annual Data Summary Report to
dean for review
 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’s level
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Review forms received from chairs
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Approve or modify any MRFs, as necessary
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Prepare School’s Annual Data Summary report
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Submit Signature Pages, Management
Reporting Forms, 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—Dept. Level
 Review of Designated Administrators/Staff
disclosures
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Ensure that all required employees have submitted and
signed a 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)
Prepare a brief annual summary of disclosures made,
and submit it to the next higher reporting authority within
the responsibility center
COI Oversight by Supervisors
Designated Administrators/Staff—Dept. Level
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Report unresolved conflicts to the provost, senior
vice chancellor for 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
COI Management Strategies
 Required prospective approval from dean or department chair
for
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Consultancies, participation in speakers bureaus, and
membership on scientific advisory boards
 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
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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
COI Management Strategies (cont’d)
 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
 Establishment of an oversight committee
 Dilution of investigator’s role in study, i.e., cannot be
PI, but may be co-investigator
Proper use of students/staff by faculty
members with outside interests
 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 acknowledging that they
have been informed
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)
 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’ inventions remain property
of University
Employment of students at faculty member’s
company
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Salary is 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 respect to
faculty’s outside consulting activities)
Proper use of students/staff by faculty
members with outside interests (cont’d)
 Reporting of troublesome COI issues
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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.
COI Management involving Startup Companies
 The Entrepreneurial Oversight Committee is
responsible for managing potential conflicts involving
start-up companies (i.e., they are not publicly traded)
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that have an option or a license for 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
Transactional Reporting
 4 COI questions appear on protocol applications
 4 COI questions apply to PI, Co-Is and research
coordinators
 PI is responsible for ensuring that all Co-Is and
research coordinators answer these questions
 Reporting must be kept current (i.e., whenever new
outside interests are accrued, a revised disclosure
must be made)
4 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. possess an equity interest in the entity that either sponsors
this research or owns the technology being evaluated that
exceeds 5% ownership interest or a current value of
$10,000? [ ] Yes
[ ] No
b. receive salary, royalty or other payments from the entity
that either sponsors this research or owns the technology
being evaluated that is expected to exceed $10,000 per
year?
[ ] Yes
[ ] No
…….
4 COI Questions on Protocols (cont’d)
c. have an agreement with the University or an external
entity that would entitle sharing current or future
commercial proceeds related to the technology being
evaluated (e.g., royalties through a license
agreement)?
[ ] Yes
[ ] No
d. have a financial relationship with a start-up company
(which is being monitored by the Entrepreneurial
Oversight Committee) that has an option or license to
utilize the technology being evaluated?
[ ] Yes
[ ] No
COI Management Involving
Specifically Regulated Research
 The COIC is responsible for managing potential
conflicts involving the following:
 Human subject research overseen by the IRB
 Invocation of the COI Committee’s Standard
COI Management Plan, as appropriate
 http://www.coi.pitt.edu/forms/StandardCOIM
gmtPlan-HSR.doc
 Animal research overseen by the IACUC
 Research on the clinically brain-dead (CORID)
 Recombinant DNA research
 Human stem cell research
Additional Help with COI
Management
 Conflict of Interest Office
 COI Office Web site www.coi.pitt.edu
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includes sample management plans,
case studies, oversight checklist for
supervisors, links to relevant policies, and
annual COI memo from the provost and the
executive vice chancellor (aka: Directive to
Disclose)
Resources: Learning about COI
 COI management presentations tailored to
specific departments, upon request
 ISER Conflict of Interest Module…
ISER Conflict of Interest Module:
Who must complete it?
 Those who completed Part II of the
University’s Faculty/Researcher form and/or
those involved in industry-sponsored
research are required to complete the ISER
COI module (Internet-based Studies in
Education and Research, formerly known as
RPF modules)
Completing the ISER Module
 Go to https://cme.hs.pitt.edu/
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click "All Modules"
select "COI Module" from list
 Test out of module
 Take chapter quizzes
 Receive certification
Completing the ISER Module (cont’d)
 at this time, re-certification is not required (despite
the “expired” note that may appear in system)
 access to the ISER database for appropriate
individuals (to determine whether the COI module
was completed) may be requested through Kathy
Sidorovich ([email protected])
Questions
Contacts/Assistance
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Jerome L. Rosenberg, PhD/Chair, COI Committee
412-624-3007 [email protected]
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David T. Wehrle, CPA, CIA, CFE/Director, COI Office
412-383-1774 [email protected]
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Khrys X. Myrddin/Associate Director, COI Office
412-383-2828 [email protected]
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Hannelore Rogers, MA/Coordinator, COI Office
412-383-1968 [email protected]
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COI Web site: www.coi.pitt.edu
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iTarget Team: 412-648-2222 for technical assistance with
Superform system