No doubt when you hear the phrase, “conflict of interest,” you think, “Yeah that is an issue, for someone else, not me!” Well, maybe not. Just because someone has a potential conflict of interest does not mean they are doing anything wrong. It is merely a recognition that an external interest they hold or activity they participate in might overlap with the roles they have at the University of Louisville.
So where does that leave us? The institution has policies and procedure available at http://louisville.edu/conflictofinterest to address conflicts of interest in order to ensure that university transactions are executed without bias. The phases of the process include: population identification, disclosure, review, management, and monitoring.
First and foremost, the institution needs to decide who will be covered by the policy. For the University of Louisville (UofL), covered persons are all university employees as well as those non-employees who perform research in the name of the institution. As you can imagine, with an organization as large as UofL, we are talking about a sizable group of people. So if every employee is covered by the policy, everyone submits a disclosure, correct? Not necessarily. A complete list of the current required disclosure population is available at http://louisville.edu/conflictofinterest.
The policy dictates those types of external activities/interests that must be disclosed on the Attestation and Disclosure Form (ADF) available at iris.louisville.edu. External interests that are related to a covered individual’s institutional role(s) (and activities) must be reported on the ADF. This includes, off campus, non-University commitments, such as company ownership, additional employment, or consulting/lectures/speaker bureau activities for external entities. Tip Sheets for disclosure requirements are available at http://louisville.edu/conflictofinterest. What information is asked on the ADF, you might ask? A wide variety of items including the nature of the activity/interest, the external organization involved, whether other UofL employees are involved, etc.
The Conflict of Interest (COI) Program works in conjunction with the Conflict Review Board to make recommendations and develop management plans for identified or potential COIs. Not everyone that completes a disclosure ha external activities/interests. Likewise, not everyone that discloses an external activity/interest will find that the institution has identified it as a COI. The review undertaken looks at the submitted information, the role(s) the individual serves at the institution and then a qualified decision is reached as to the existence of a COI or not. If a COI exists, then management is developed.
Management plans are the mechanisms by which the institution seeks to mitigate identified COIs. These documents include a variety of clauses and statements that guide individuals with COIs in the best way to ensure that their external activities/interests do not adversely affect or influence their role(s) at UofL. In some cases, it might call for an additional review of collected data, or having someone else prepare billing paperwork, or naming another individual as an advisor to students working on the project. Each item in the plan should work in concert with the others to provide the proper protections for the institutional activities. In order to ensure that the plans are working as intended, they must be monitored.
This activity occurs at various levels. First line of defense is actually with the covered person. Wait a minute. Are you saying the individuals monitor themselves? Absolutely - to a certain extent. The covered person is in the best position to know when something he/she has disclosed is no longer applicable. At that point in time, this change is communicated to the COI Program and modifications to the plan may be in order. Additionally, the institution relies on the individual’s direct supervisor/appropriate authority. These individuals are most closely aware of the covered person’s institutional responsibilities and can monitor how the plan is affecting execution of those duties. Next we have the COI Program itself. Information can be culled from external sources/reports that might have bearing on the management plan. Further, it is the COI Program’s responsibility to keep up to date with the best practices in the area of COI identification and management.
While COIs can certainly be complex, we hope that this article serves as a brief, but helpful introduction. If you have additional questions or concerns related to COIs, please do not hesitate to contact the COI Program at firstname.lastname@example.org.
Submitted by the Conflict of Interest Office 06/23/17