Frequently Asked Questions about Conflict of Interest
Outside Activities Reporting (OAR)
1. What is a Conflict of Interest?
A Conflict of Interest (COI) exists when an investigator has a
significant financial interest (SFI) 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. “Personal gain” encompasses direct,
personal benefits AND benefits to an individual’s immediate family.
COIs simply represent a state of affairs, not behavior. If the COI Committee determines an investigator has a COI, it does not imply wrongdoing on anybody’s part.
2. What is a Significant Financial Interest (SFI)?
A Significant Financial Interest (SFI) is a financial interest that is held: (1) by an individual or a member an individual’s immediate family; or (2) by a business entity that is controlled or directed by an individual or a member of an individual’s immediate family.
To be significant, the financial interest has to reasonably be related to the individual’s institutional responsibilities at UW-Madison, and also needs to meet one of the follow criteria:
(1) For publicly traded entities:
a. The value of remuneration received from the entity in the twelve months preceding the disclosure in combination with the value of any equity interest in the entity as of the date of disclosure exceeds $5,0000.
(2) For non-publicly traded entities:
a. The value of any remuneration received from the entity in the twelve months preceding disclosure, when aggregated, exceeds $5,000
b. The investigator holds any equity interest in the entity
(3) Any income from intellectual property rights that are not assigned to organizations created to manage such rights on behalf of the University of Wisconsin-Madison;
(4) Service in positions with fiduciary responsibility. This includes executive positions, senior management, or membership on boards of directors; and
(5) For those that receive PHS funding, reimbursed or sponsored travel.
3. Who must complete an Outside Activities Report (OAR)?
Chapter 8 of the University of Wisconsin System Board of Regents requires all faculty (regardless of appointment) and all academic staff with a 50% or greater appointment to annually file an OAR. Individuals with active management plans from the COI Committee must file annually as well.
Additionally, PHS regulations require all individuals listed on human subjects protocols or federal grants to file OARs annually and whenever they undertake new outside activities. See 42 C.F.R. Part 50, Subpart F.
4. What is reportable in my OAR?
All outside activities related to your institutional responsibilities should be reported, including your spouse's or immediate family's outside activities.
The term “institutional responsibilities” encompasses all of your professional responsibilities at the University of Wisconsin-Madison, including: research, instruction, extension/outreach, and administrative activities.
5. When is it appropriate for me to report updates to my OAR?
Faculty and academic staff are responsible for updating their reports anytime there is a relevant change in their outside activities (e.g. new relationships with outside organizations or increased compensation for an on-going activity). An updated version of the outside activity report may be completed at any time during the year by logging back into the Outside Activities Report.
6. What should I do when a relationship with an outside activity has ended?
Update your OAR to record the end date of the activity. You may log back into your Outside Activities Report. If you have a Management Plan for the activity that has ended, please notify the COI Program and they will terminate your Management Plan.
7. Can I file an OAR for another person?
No. Each individual must log in with their own NetID and password to file an OAR. In addition, you must certify that all of the information is accurate before submitting your OAR.
8. Who can you contact if you need assistance filing your OAR?
You can find the CIO contact for your School, College or Division here: Individual Conflict of Interest: Who to Contact for Assistance If you need additional help, please contact the COI Program at firstname.lastname@example.org or call Sam Leinweber (608) 890-4603 or Stephanie LeRoy at (608) 890-4460.
9. Do I have to report travel in my OAR?
If you receive any funding from PHS, you must report sponsored or reimbursed travel on your OAR. If you do not receive funding from PHS, you will not be asked the travel questions. If your travel is paid through the UW’s e-reimbursement system, you do not need to report it.
10. I was assigned a management plan, what should I do next?
There are 4 things to do at this time. First, follow the instructions in the email to accept you management plan. Second, schedule a meeting with your Chair or Director to make them aware of your management plan and to discuss the requirements of the plan. Third, draft a notification letter to staff and students you supervise and all co-investigators on grants to inform them of your outside activity. Finally, you must provide a copy of the management plan to a reviewing IRB within 30 days of the assignment of the plan if it relates to the study. You will receive an email outlining these steps when a Management Plan is issued by the COI Committee.
11. What happens if I disagree with the requirement for a management plan?
If you disagree with the assignment of a Management Plan, please contact your Dean's Office . While reasonable efforts will be made to process your appeal as expeditiously as possible, please note that the appeal process may delay spending on PHS awards.
12. How does my management plan impact protocol submission?
If you have a Management Plan, your protocol submission may be affected. Absent written approval from the COI Committee, you cannot serve as principal investigator (PI), co-investigator (co-I), or key personnel for a human subjects protocol reviewed by a UW-Madison IRB if the entity which has been assigned a Management Plan: a) sponsors the study, or b) owns or licenses a technology tested in the study. You may work with you Dean’s Office to apply for an exception to this provision.
13. How do I apply for an exception to my Management Plan?
You must work with your Dean’s Office to request an exception from the COI Committee. For more information see Financial Conflict of Interest Policy and Procedures: Guidance Document.
14. What is the Online COI Training Course?
It consists of 4 modules covering the UW Madison Conflict of Interest Policy and its requirements. The results can take up to 24 hours to appear in the Training Lookup Tool.
15. Do I have to complete the Online COI Training Course?
If you receive federally funded awards or are conducting human subjects research, you must complete the COI Training course at least once every 4 years. You access the COI Training course via Learn@UW. Use your NetID and password to log into Learn@UW. For further details, Conflict of Interest Training Course .
16. What is the first step I need to take as a subrecipient?
If you do not have your own PHS compliant COI Policy, you must follow the UW Madison’s COI Policy. This means you must file an OAR and take the COI Training course. In order to do so, you will need a UW NetID and password. The UW Conflict of Interest Program will assist you in obtaining a NetID from the UW Department of Information Technology. To request a NetID, please click Subrecipient NetID.Top
17. If I am on a PHS grant, what are my COI related responsibilities for award setup?
If you receive a Notice of Award for a PHS funded grant, you will need to do 2 things. First, if you have not filed an OAR in the past 30 days, you will need to file an Outside Activities Report even if nothing has changed. Second, you must take the COI Training course if you have not completed the course in the past four years. You may access the course by self-registering at Learn@UW.
Keywords: conflict of interest, outside activity report, management plan, travel reporting, COI Training, Subrecipients, award setup