1. Financial Conflict of Interest in Research SEMINAR
Martha Hedberg, MPA
Joanne Seeberger, MS
UI Conflict of Interest in Research Office
Office of the Vice President for Research & Economic Development

2. The presenters have no conflicts of interest related to this presentation
Office of the Vice President for Research & Economic Development

3. What does conflict of interest mean?
Tug of war between interests
An individual or an organization is involved in multiple interests, one of which could negatively influence the other. In other words, it is a tug of war between the interests. A conflict of interest can only exist if a person or an organization has been entrusted with some impartiality; trust is necessary to create situations of conflicts of interest.
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4. Is a COI bad? No Common to collaborate Mutual benefit of collaboration
Commercialization enhances economic development
Common good for society. Think of all of the advances that we have made that probably included some sort of collaboration – medicine, physics and space exploration, safer travel and so on…
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5. What is a financial interest?
Personal
Money
Stock, stock options
Company ownership
Royalty/licensing income
Fiduciary Duty
PHS Researchers – Sponsored Travel
Or anything of monetary value related to your role at the University
Anything of monetary value, whether or not the value is readily ascertainable, in any of the these categories. For investigators conducting PHS funded research, sponsored travel is also included in this list.
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6. How can it be related to research?
Potentially enhanced by research
Compromise objectivity
Appearances are everything
This is a situation in which a researcher has a personal financial interest that may compromise, or have the appearance of compromising the objectivity of the research.
Another way of thinking about this is whether or not the interest appears to be affected by the research, or is in an entity, a business, whose financial interest appears to be affected by the research. And then, could that interest impact the design, conduct or reporting of that research?
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7. A financial interest becomes a conflict of interest in research
Interest is directly related to the research
The value could be enhanced
The entity could benefit
Interest has reached a threshold
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8. What are the Thresholds?
Personal compensation >$5,000
Equity in a public company valued >$5,000
Aggregated value of the above >$5,000
Equity (ownership) in a non-public company
Position with Fiduciary Duty
Income from intellectual property
Did the investigator receive remuneration over $5,000?
Does the investigator have stock in a publicly traded company valued greater than $5,000?
Does the aggregated value of remuneration and stock together equal more than $5,000?
Is there any level of ownership in a non-publicly traded company? Startup companies.
Does the investigator have a position with fiduciary duty with a company? (Board of Directors/manager/employee, but not Scientific Review Panel)
Has the investigator received licensing income or royalties from intellectual property? All of you inventors out there…
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9. Is this a Conflict of Interest Related to Research?
Mead & Johnson, the maker of Enfamil baby formula, is sponsoring a study examining the nutritional value of a new powder baby formula. The study will examine the product’s overall effectiveness in infants who have exhibited symptoms of lactose intolerance with more traditional formulas. The PI of the study, Dr. Bob White, has a consulting agreement with Mead & Johnson, and he receives personal compensation for advising the company on its product development.
(Don’t answer…see if any audience member offers an answer…refer to this case later with more details.)
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10. Whose Financial Interests Must Be Disclosed?
Key Personnel
Spouses and dependent children of Key Personnel
A few bad apples…
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11. Key Personnel Principal Investigator Other Study Team Members
Authors on Manuscripts
Conference Presenters
NOT administrative personnel
Not members of the study team who are conducting routine, pre-defined or incidental tasks related to the project. It only applies to members of the study team who have the ability to directly affect the design, conduct or reporting of the research. If you still are not sure, ask yourself if you will be listed as an author on a publication or a presentation. If the answer is “yes,” then you meet the definition of “key personnel.”
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12. Who Reviews the Disclosure Forms?
COIR Office
Makes Financial COI Determinations
Conflict of Interest in Research Committee
Proposes management plan
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13. Management of FCOI in Research
Conditions to control, reduce or eliminate the FCOI
Disclosure
Independent monitor
Elimination of the interest
Withdraw from the study
Disclosure in publications & presentations
Disclosure to students/trainees
For human subjects, disclosure in the informed consent document
Appointment of a independent party to analyze/review the data
Exclude the investigator from certain research activities, such as obtaining informed consent – creates a firewall
Investigator may be required to withdraw from the study
Investigator may elect to, or be required to divest him or herself from the interest.
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14. Case Study DISCUSSION Is there a financial interest?
What financial interest(s) is present?
Does the interest create a financial conflict of interest?
What might the Committee recommend?
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15. What You Need to Do: Complete disclosure Complete COI training
ecoi.uiowa.edu
Complete COI training
Future considerations
Training is embedded in the eCOI system
Be cognizant of future situations that could create a financial interest for you as a researcher. Remember – it is okay, but you must enter into these personal agreements with your eyes wide open and consider any future impacts it may have on your research.
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16. Concerns UI Compliance Hotline UI Internal Auditor’s Office Contact Us
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17. The Bottom Line COI is not inherently “bad”
Transparency is always good
Disclose in eCOI (ecoi.uiowa.edu)
Questions?
Contact us
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