Conflict of Interest
Much of the following
material is reproduced and adapted from the University of Minnesota curriculum
and is used with permission http://www.research.umn.edu/ethics/.
1. Describe the circumstances in which conflict of interest might
occur in your research. Is this a
financial conflict of interest? Should
it be disclosed?
2. Given a list of activities, 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.
3. Given brief descriptions of cases involving potential or actual
conflicts of interest, distinguish better from worse actions for managing the
conflicts.
Relevant University of
Memphis Policies and Procedures
Conflict
of Interest (Financial or Business)
http://policies.memphis.edu/Policies/12a_General_Policies/12a1105.html
http://policies.memphis.edu/Procedures/2a_General_Procedures/2a1801a.html
http://policies.memphis.edu/Procedures/2b_Academic_Procedures/2b0112a.html
http://policies.memphis.edu/Procedures/2b_Academic_Procedures/2b0112b.html
Outside
Consulting, Service Activities, and Other Work-
http://policies.memphis.edu/Policies/12a_General_Policies/12a0202.html
Conflict
of Interest (Purchasing)
Public-Private
Partnerships
Use
of Faculty Authored Textbooks
http://policies.memphis.edu/Policies/12a_General_Policies/12a1401.html
Reporting
Inventions Patents and Copyrights and Fair Use
http://policies.memphis.edu/Policies/12b_Academic_Policies/12b0111.html
http://policies.memphis.edu/Procedures/2b_Academic_Procedures/2b0111a.html
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.
Disclosure of even potential conflicts of interest is of paramount
importance. Conflict of interest
generally arises when one is engaged in a dual role. For example, one may be both an investigator and an investor in
or owner of a product being investigated.
The role of investigator, which requires some degree of objectivity and
disinterest, may come into conflict with the role of investor or owner, both of
which entail some desire to see favorable results that will protect an
investment or advance the benefits of ownership. Dual roles always require careful scrutiny to avoid conflicting
interests.
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.)
Financial 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 states:
"Professional staff
members of the University must avoid circumstances which improperly favor their
own outside financial interests over those of the University.."
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 eight hours per month 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).
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.
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.
Required Disclosure
The University requires
annual disclosure by all faculty members.
The information is submitted electronically as:
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
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 Vice Provost for
Research. Final resolution must be
reached within 30 days of submitting the original disclosure.
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.
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
Determine
the best and worst ways of dealing with the potential conflict.
Case No. 1 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. Is there a conflict of interest? If so, how should this be managed regarding
the faculty member and the graduate student?
Case No. 2 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.
Should the researcher have disclosed the source of funding? If so, what can now be done to rectify the
situation?
Case No. 3 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 chemical 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. What actions should the University Conflict
of Interest Committee take in this situation?
FURTHER READING
http://grants.nih.gov/grants/policy/emprograms/overview/ep-coi.htm
Association of American
Medical Colleges (1990). Guidelines for dealing with faculty
conflicts of commitment and conflicts of interest in research. Washington, D.C.: Author.
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., & T. E.
Malone, Eds. (1993). Biomedical research: collaboration and
conflict of interest. Baltimore:
The Johns Hopkins University Press.
Responsible science: Ensuring the integrity of the
research process. Washington, D.C.:
National Academy Press, 1992.
Boyd, E. A. & Bero, L.A. (2000). Assessing faculty financial relationships with industry: A case
study. Journal of the American Medical
Association;284(17), 2209-14. Available
from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11056592.
Cho, M. K., Shohara, R.,
Schissel, A., & Rennie, D. (2000). Policies on faculty conflicts of interest at
US universities. Journal of the American Medical Association, 284(17):2203-8. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11056591.
McCrary, S. V., Anderson, C.
B., Jakovljevic, J., Khan, T., McCullough, L.B., Wray, N.P., et al. (2000). A national survey of policies on disclosure of conflicts of
interest in biomedical research. New
England Journal of Medicine;343(22):1621-6. Available from http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=11096171.
Association of American
Universities Report http://www.aau.edu/research/COI.01.pdf
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