UW Conflict of Interest Program Manager Office of Research Policy CONFLICTS OF INTEREST University Hat Kelly Ullrick, J.D. UW Conflict of Interest Program Manager Office of Research Policy UW Graduate School kullrick@grad.wisc.edu

What is a Financial Conflict of Interest? A conflict of interest exists when an investigator has a significant financial interest that could lead an independent observer to reasonably question whether the design, conduct or reporting of research might be influenced by the possibility of personal gain (individual or immediate family)

UW Perspective The University encourages faculty and staff to: Engage in outside activities Share expertise Transfer intellectual property to the private sector The University asserts that: Conflicts of interest are common and frequently unavoidable Conflicts of interest are not inherently “bad” Conflicts of interest can often be managed by using a series of best practices, i.e., management plans

Significant Financial Interests OUTSIDE ACTIVITIES OF MONETARY VALUE, including but not limited to: Compensation for outside activities exceeding $10,000 in any single year; likely $5000 soon Equity interest that exceeds $20,000 or that exceeds 5% ownership interest in a publicly held entity; this threshold may also change soon ANY interest in a privately held entity; Any leadership position

Individual Obligations Complete and submit an annual outside activities disclosure Fulfills State of WI, UWS and Federal requirements Revise the annual report whenever there is significant change in: Outside activities or significant financial interests Relationships with outside enterprises Significant changes in research activities including sponsored research

UW COI Committee Responsibilities Reviews all OAR submissions made on a yearly basis (~9500/y) and also any updates Determines whether conflict situations exist that may require management (~500/y) Assigns management using financial thresholds and consideration of nexus between university activities (federal funding and/or human subjects research) and outside activities (~400 active management plans) Investigator interviews and committee experience contribute to assignments

Management Plans Provisions in a Management Plan include: Disclose significant financial interests in publications and presentations Disclose significant financial interests to students, staff, and co-investigators Disclose proposed research support from any outside entity to the Dean’s Office Obtain written facilities use agreements before use occurs Have oversight of any purchases from outside entity Complete annual review of management plan with Chair ***Provide timely updates of activities report***

Management Plans II IF … you engage in Human Subjects Research, the following provision is included in your Management Plan: Absent written approval from the COI Committee, you cannot serve as principal investigator (PI), co-investigator (co-PI), or key personnel for a human subjects protocol reviewed by a UW-Madison IRB if the outside entity: sponsors the study, OR owns or licenses a technology tested in the study

Exception? … Maybe The COI Committee may grant you an exception to these restrictions on participation in human subjects research Exceptions are ONLY granted for specific protocol Your Dean’s Office must approve and submit an exception request on your behalf to the COI Committee Very rare – may be granted if, for example, an individual is uniquely qualified by virtue of expertise or experience to participate in the research

Additional Information Graduate School Office of Research Policy http://www.grad.wisc.edu/research/policyrp/oar/index.html UWS, State of WI and Federal Regulations http://www.grad.wisc.edu/research/policyrp/ethicsguidance.html UW Conflict of Interest Committee http://www.grad.wisc.edu/research/policyrp/coi/index.html