| Conflict
of Interest
Learning Objectives
University Policies and Procedures
Curriculum Overview
Case Studies
Information Resources
Learning
Objectives
- Describe the circumstances in which conflict of interest might
occur in your research.
- Given a list of activities or external relationships, indicate
those that require disclosure (based upon University policy) and
the degree (low, moderate, or high) to which each activity or
relationship has the potential for a conflict of interest.
- Given brief descriptions of cases involving potential or actual
conflicts of interest, distinguish better from worse actions for
managing the potential conflicts.
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University
Policies and Procedures
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Curriculum
Overview
Priniciples
The University is committed to having its employees conduct themselves
in accordance with the highest standards of integrity and ethics,
and in compliance with applicable state and federal laws related
to conflict of interest and objectivity in research.
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Definitions
There are many areas in which a potential conflict of interest
may arise. These include the following. (See Scientific Integrity
by F. L. Macrina for a more detailed discussion.)
Conflict of interest:
- Although the legal definition varies from state to state, conflict
of interest basically involves any situation in which an individual
exploits his or her position for personal or financial gain. This
is probably the most important type of conflict because of its
visibility and the potential for damage to the reputation of the
University and all concerned. The University's Conflict of Interest
Policy defines conflict of interest explicitly as follows:
- "A conflict of interest occurs when Academic Employee compromises
his/her professional judgment in carrying out University teaching,
research, outreach, or public service activities because of an
external relationship that directly or indirectly affects the
Financial Interest of the Academic Employee, and Family Member,
or any Associated Entity."
- An obvious example would be the ownership of-or a major interest
in-a private firm by a faculty member who also has the decision-making
responsibility in awarding a contract to that firm. Sponsorship
of research by commercial firms in which the faculty member has
a significant interest is another obvious example. However, many
potential conflicts of interest can be more complex and not so
clearly discernible.
Scientific conflict of interest:
- This type of conflict involves participation in review panels
or other groups that make decisions regarding the allocation of
resources or the publication of papers or someone who offers scientific
testimony as an expert witness. Possible conflicts in review panels
or refereeing are usually handled by excusing the person with
the potential conflict. The situation with expert testimony is
not so clear, but the individual's background and connections
should be revealed before the testimony.
Academic conflict of interest:
- This involves utilization of the name and/or the resources of
the University for personal gain.
Conflict of commitment or effort:
- Non-University activities that require considerable time and
effort could lead to a significant decrease in the time and effort
devoted to the employer, the University. The University has a
Policy on Outside Consulting, Service Activities, and Other Work
that basically allows the equivalent of one day per week for outside
consulting or other professional activities. The policy requires
approval in advance for activities that demand more than one day
per month (on average) and reporting of all activities in which
more than three days per term are spent.
Conflict of conscience:
- Such a conflict can arise when an individual's personal convictions
(e.g., religious, ethical, or moral) are so strong that they influence
the decision being made. There are no widely accepted procedures
for dealing with conflicts of this type.
Nepotism:
- In the past, the employment of two related individuals (e.g.,
a married couple) in the same department was not allowed by anti-nepotism
rules. Now, the matter is handled by a rule that simply states
such individuals cannot participate in any decisions affecting
the other person.
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Topics for Discussion
Conflicts of Interest Policy
The University's relationship with the public and private sectors
is an important part of its mission, and such relationships are
encouraged. It is recognized, however, that such relationships
can lead to a variety of conflicts of interest (perceived, potential,
or real) that may result in personal financial compensation or
other personal gain. Faculty and University risks can be large
when potential conflicts are not appropriately handled.
The University also recognizes that it has an obligation to guarantee
faculty members a free climate in which to carry out their research
and scholarly activities. It recognizes that licensing of technology,
consulting, starting new businesses, and other forms of technology
transfer are necessary to serve the needs of society, as well
as to enhance the research and educational experience of students
and faculty.
Public awareness of conflict situations and involvement in their
investigation have greatly increased in recent years. It therefore
behooves the University and its faculty to be exceptionally careful
in making arrangements with external agencies and commercial interests,
not only to deal with potential conflicts of interests, but also
with the perception of those conflicts.
The Conflict of Interest Policy has been developed to ensure
that potential conflicts are disclosed by faculty members, reviewed
by the relevant administrators and committees, as necessary, and
a satisfactory resolution reached. The policy applies to all employees
of the University when they are responsible for, or in a position
to influence:
- The design, conduct, or reporting of research or other scholarly
activity; or
- Teaching or advising; or
- Performing outreach or other public service activities.
It also applies to specified combinations of activities and financial
or business interests, as well as to those employees who have
direct or indirect influence over purchasing decisions or contracts.
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Required Disclosure
The University requires annual disclosure by all faculty members
and disclosure within 30 days of any significant change in circumstances.
The information is submitted electronically as the "Annual
Report of External Professional Activities" (or AREPA, which
replaces University Form 15) and "Request for Consultant
or Outside Service Agreement" (or ROC, which replaces Form
14), respectively. These forms are found on the SPA website at
http://nirvana.ospa.umn.edu under "OSPA Forms" and are
accessed by clicking on "Make a Request."
Disclosure of financial or business interests is required when:
- An employee and immediate family members:
- have an equity interest in a business representing ownership
of five percent or more or a value of $10,000 or more; or
- have an income from a business of $10,000 or more; or
- expect royalties of $10,000 or more; or
- have a business interest
- Submitting a proposal for sponsored research
- A gift valued at more than $100 is received
- Involved with review or advisory activities
- Involved with technology transfer
- Reporting research results
- Presenting facts or opinions before any public body, commission,
or group
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Review Process
The final level of approval depends on the category for potential
conflict:
Category I: Activities exempt from disclosure.
Category II: Activities and external relationships that have
the potential for conflict of interest. This category is further
divided into two sections-activities that have minimal to moderate
potential for conflict, and activities that have moderate to high
potential for conflict.
Category III: Purchasing goods and services. The disclosure forms
are reviewed at the departmental level and forwarded to the dean
with a recommendation for resolving or managing a potential conflict
of interest. The dean's recommendation is then reviewed by the
Conflict Review Committee and the Public-Private Partnership Committee,
as necessary, and the final resolution is approved by the provost
or the vice president. Final resolution must be reached within
30 days of submitting the original disclosure.
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Managing Potential Conflicts
Exclusion from decision-making process: In cases in which a faculty
member has a significant financial interest in a company that
is doing business with the University and is in a position to
influence a decision involving a company's contract with the University,
the faculty member must excuse him or herself from the decision-making
process.
Monitoring of research: Research being done for a commercial
company or sponsoring agent could be monitored by an independent
body to ensure that undue influence is not being exerted on the
results.
Modification of research plan: The proposed research may have
to be carried out in such a way so as to avoid conflict, bias,
or undue influence.
Divestiture of financial interests: In some cases, the only way
to remove a conflict of interest is to divest oneself of one's
financial interest in a company.
Non-participation: Disqualification from participating in a research
program affected by financial interests may often be the simplest
means to avoid a conflict.
Severance of relationships: Resignation from management positions
or government boards that create actual or potential conflicts
may be necessary to remove the conflict.
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Case
Studies
For all of the following cases:
- Identify and discuss the conflicts (real, potential, or perceived);
- Clarify the issues and how they relate to policy;
- Develop possible remedies;
- Determine if disclosure is required;
- Ascertain the category in which the potential conflict falls;
and
- Determine the best and worst ways of dealing with the potential
conflict.
Case No. 1: University Agribusiness
Links
As recently reported in the Minneapolis Star Tribune, the Environmental
Quality Board is planning to conduct a two-year environmental
study of livestock operations (feedlots, in particular). The Board
carries out its studies by hiring researchers to conduct various
portions of the work. A citizen's advisory group has been meeting
for more than a year to develop guidelines for the study and has
identified 12 topics of concern related to the social, economic,
environmental, and health effects of large-scale livestock production.
One of the participating groups, Clean Water Alliance of Minnesota,
has resigned from the study's advisory group claiming that the
study's conclusions would be predictably in favor of expanded
livestock operations because it will be done by University of
Minnesota researchers who have received hundreds of thousands
of dollars from agribusiness interests, such as the Minnesota
Pork Producers, the National Pork Council, and the Farm Bureau.
Clean Water Alliance's perception is that the study would not
seriously consider the legitimate concerns of citizens living
near the feedlots because of the strong agribusiness connection
of the researchers.
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Case No. 2: Faculty Member's Business
Interests
A faculty member has obtained an exclusive license from the University
to market a complex software program to computer manufacturers
and users that would enable them to perform certain large-scale
operations much more efficiently. The faculty member has set up
a small company to manufacture and sell this software, which was
developed with University resources, as well as some external
support in the form of computer hardware donated or loaned to
the research group. He has assigned a research project to a graduate
student in his research group that is clearly designed to enhance
the performance and marketability of this software. He has not
made any disclosure about his role in his company because he does
not see any conflict.
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Case No. 3: Industry Sponsored Research
A drug company sponsored a major study of the side effects of
a certain medication designed originally to relieve mild depression.
The results indicated no significant side effects except in a
very small fraction of the study population which experienced
minor inconveniences such as headaches and occasional dizzy spells.
The study results were published in a reputable journal and given
wide coverage by the press. The medication was given a seal of
approval, backed by this study which was conducted by a prestigious
researcher at an equally prestigious university. Sales of the
medication increased dramatically, and company profits reached
an all-time high.
The researcher neglected to indicate in the published article
or elsewhere, however, that the study had been sponsored by the
company that benefited so greatly from its favorable findings.
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Case No. 4: Public Testimony
A university professor testified at an environmental impact hearing
that the proposed construction of a chemical production facility
will have no negative impact on the surrounding community even
though the plant will be dealing with highly toxic materials,
some of which are in gaseous form. The company claimed that the
dangers to the community are very slight because of the safety
measures they propose to take, and they quoted the results of
a detailed engineering analysis carried out by the professor's
graduate students.
The research had been originally supported by a grant from a
federal agency, but when that expired, funding was provided by
the company. At no time during the testimony, however, did the
professor or the company reveal that the research had been supported
financially by the company.
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Information
Resources
Further Reading
Guidelines for Dealing with Faculty Conflicts of Commitment and
Conflicts of Interest in Research. Washington, D.C.: Association
of American Medical Colleges, 1990.
Macrina, Francis L. Scientific Integrity: An Introductory Text
with Cases. American Society for Microbiology Press, 1995. (This
book contains many excellent references, some of which are listed
here.)
Porter, R. J., and T. E. Malone, editors. Biomedical Research:
Collaboration and Conflict of Interest. Baltimore: The Johns Hopkins
University Press, 1992.
Responsible Science: Ensuring the Integrity of the Research Process.
Washington, D.C.: National Academy Press, 1992.
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