COI Regulatory Changes
Supporting Materials
| NEW (8/30/12): Guidance Document | A comprehensive document that explains the UW-Madison COI Policy. |
| Key Terms | One-page explanation of terminology in the federal regulations |
| REVISED (8/28/12): Summary of Regulatory Changes | Two-page table summarizing the new regulatory requirements, highlighting important changes |
REVISED (8/28/12): Powerpoint |
Presentation highlighting important changes to federal financial COI regulations |
| REVISED (8/28/12): Summary and Application of Provisions | Table summarizing which provisions under the new federal regulations apply to all investigators with federal funding and/or are engaged in human subjects research, or to only those investigators with funding from Public Health Services (e.g. NIH). |
New Federal Policy on Financial Conflicts of Interest
The federal policy on financial conflicts of interest has changed as of August 24, 2012.
Under current UW-Madison policy,
- All faculty, regardless of appointment, and all academic staff with greater than 50% appointment at UW-Madison, as well as 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.
New Regulatory Requirements that Require Your Attention
While much of our practice in managing financial conflicts of interest has not changed, there are several new elements in the federal policy that require your attention.
Key Changes You Should Know About
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 is included in the definition of an SFI for PHS-supported investigators
2. All outside financial interests related to institutional responsibilities must be disclosed.
- This includes all research, instruction and extension / outreach activities
3. New or increased outside financial interests must be disclosed within 30 days of the start of that new or increased financial interest. The "start" of a new financial interest can be triggered in many ways, including:
- Entering into a consulting agreement, or
- Purchasing stocks, or
- Forming a legal entity (e.g. 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.
4. The nature and monetary value of any SFI that is determined to constitute a financial conflict of interest will be posted on a publicly accessible web site or provided to requestors 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.
- This requirement will apply only to PHS-funded investigators.
- OARs and Management Plans are public records and will continue to be available by request under Wisconsin's public records law.
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.
What does this mean for me?
Example 1
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.
Response:
- OAR declaration required
- No significant financial interests exist
- No management needed
Professor A represents 95% of UW faculty and staff.
Example 2
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.
Response:
- OAR declaration required
- 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 3
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.
Response:
- 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 4
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.
Response:
- OAR declaration required
- Management is required if the ownership interest is related to Professor D’s research regardless of monetary value
Example 5
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).
Response:
- 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)
UW-Madison Working Group
The Graduate School has the primary responsibility for research policy on our campus. A working group composed of faculty, staff, administrators, and compliance experts analyzed the new federal policy, examined the existing UW-Madison COI Policy and Program, and recommended a process for meeting the new requirements.
The working group shared its recommendations with Graduate School leadership who have worked with school and college representatives and campus leaders to implement the process.
COI Office: Contact Information
If you have questions about the new federal policy and/or changes to the UW-Madison COI Policy and Program, please contact us.
Email: coiprogram@grad.wisc.edu
Kelly Ullrick, COI Program Manager: 608/890-1613