1. New Federal Policy on Financial Conflicts of Interest Matt Richter, MA, JD anticipated 2012 COI Program Specialist Office of Research Policy msrichter@grad.wisc.edu

2. New Federal Policy on Financial Conflict of Interest The Federal policy on financial conflicts of interest has changed. Those changes will be implemented across the country on August 24, 2012. Under current UW-Madison policy, All faculty and staff with greater than 50% appointment at UW-Madison and all individuals listed on human subjects protocols or federal grants are required to fill out an Outside Activities Report (OAR) each year and whenever new outside activities are undertaken. Review of OARs is handled by the Graduate School and the campus Conflict of Interest Committee. This is the way our campus identifies any financial conflicts of interest for faculty, staff, and other researchers. The new federal policy requires important changes to our reporting and management of financial conflicts of interest. Because of the scope of changes needed to meet the new federal policy requirements, it is important for the campus community to become aware of these changes before the August 24, 2012 implementation date.

3. UW-Madison Working Group: A working group has been actively developing a process for our campus to meet new federal policy requirements. The Graduate School has the primary responsibility for research policy on our campus. Dean Bill Mellon has appointed a working group composed of faculty, staff, administrators, and compliance experts to help recommend a process for meeting the new requirements. The working group will share its recommendations with Dean Mellon, who will work with school and college representatives and campus leaders to implement the process. How UW-Madison will Meet the New Federal Policy

4. While much of our practice in managing financial conflicts of interest will not change, there are several new elements in the federal policy that require your attention. These changes are outlined in the next two slides. New Regulatory Requirements that Require Your Attention PUT LINK TO COI CHANGES WEB PAGE HERE

5. 1. The new federal definition of an amount constituting a Significant Financial Interest (SFI) is decreased to $5,000 This new threshold is reduced from the previous $10,000 threshold. An SFI includes the sum of paid compensation, ownership in companies and leadership positions. Reimbursed or sponsored travel may be included in the definition of an SFI only for PHS-supported investigators. (The federal government is still assessing this provision.) 2. All SFI related to institutional responsibilities must be disclosed This includes all research, instruction and extension/outreach activities. 3. New or increased SFI must be disclosed within 30 days of Entering into a consulting agreement, or Purchasing stocks, or Forming a legal entity (signing partnership papers, filing articles of incorporation). This means you are obligated to update your Outside Activity Report (OAR) whenever a new activity begins during the year. 6 Changes You Should Know About

6. 4.The nature and $ value of any SFI determined to constitute a financial conflict of interest will be posted on a publicly accessible website or provided to requesters within 5 business days The new federal policy requirement is to assure greater accessibility of the data on potential financial conflicts of interest to the public 5.FCOI training for PIs, key personnel and human subjects researchers is required before engaging in PHS-funded research and at least every 4 years thereafter 6.August 24, 2012 is the effective date for implementation of the new regulations OARs and Management Plans are public records and will continue to be available by request under Wisconsin’s public records law.

7. What does this mean for me? Professor A has a salary paid by UW, has federal grant funding and/or is listed on a human subjects protocol. Neither Professor A nor members of his or her immediate family receive compensation for outside activities, have any ownership interests, and do not have a leadership position with fiduciary responsibility in an outside entity. OAR declaration required No significant financial interests exist No management needed Professor A represents 95% of UW faculty and staff. Example 1

8. What does this mean for me? Professor B has a salary paid by UW, has federal grant funding and/or is listed on a human subjects protocol, and receives consulting fees for one or more outside activities. OAR declaration require If the payment from an individual outside entity is less than $5000, then no significant financial interest exists, and no management is necessary If the payment from an individual outside entity is greater than $5000, a significant financial interest exists Management is necessary if the interest in the outside entity is related to Professor B’s research Example 2

9. What does this mean for me? Professor C has salary paid by UW, has federal grant and/or is listed on a human subjects protocol, and owns stock in a publicly traded company. OAR declaration required If the value of the stock is less than $5000, no significant financial interest exists and no management is needed If the value becomes greater than $5000, a significant financial interest exists Management is required if the ownership interest is related to Professor C’s research Example 3

10. What does this mean for me? Professor D has a salary paid by UW, has federal grant funding and/or is listed on a human subjects protocol, and has ownership in a privately held entity. OAR declaration required Management is required if the ownership interest is related to Professor D’s research regardless of monetary value Example 4

11. What does this mean for me? Professor E has a salary paid by UW, has federal grant funding and/or is listed on a human subjects protocol, and has a leadership role in a company with fiduciary responsibility (founder, officer, treasurer). OAR declaration required Management is required if the leadership role is related to Professor E’s research and additional significant financial interests are present (e.g. equity ownership or compensation) Example 5

12. Conflicts of Interest PUT LINK TO COI CHANGES WEB PAGE HERE ADDITIONAL INFORMATION