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

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

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. OVPR&ED

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… OVPR&ED

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. OVPR&ED

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? OVPR&ED

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 OVPR&ED

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… OVPR&ED

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.) OVPR&ED

Whose Financial Interests Must Be Disclosed? Key Personnel Spouses and dependent children of Key Personnel A few bad apples… OVPR&ED

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.” OVPR&ED

Who Reviews the Disclosure Forms? COIR Office Makes Financial COI Determinations Conflict of Interest in Research Committee Proposes management plan OVPR&ED

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. OVPR&ED

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? OVPR&ED

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. OVPR&ED

Concerns UI Compliance Hotline UI Internal Auditor’s Office Contact Us OVPR&ED

The Bottom Line COI is not inherently “bad” Transparency is always good Disclose in eCOI (ecoi.uiowa.edu) Questions? Contact us OVPR&ED