Conflict of Interest Committee
Reducing or Eliminating Conflicts of Interest to Avoid Management
A Principal Investigator (PI) conducting human subjects research can eliminate a potential conflict of interest (COI) between a research protocol and a personal financial interest or outside activity and, as a result, avoid or terminate a COI management plan in the following ways:
- If the COI is based on the existence of a significant financial interest, the investigator may divest the financial interest or reduce the interest below specified financial thresholds; then, update his or her Outside Activities Report and contact the COI Committee, as described in the procedures below.
- If the COI is based on an outside activity, the investigator may end the outside activity; then, update his or her Outside Activities Report and and contact the COI Committee, as described in the procedures below.
- If the COI arises from the sponsorship or other involvement of an outside entity with a human subjects protocol, the investigator can eliminate the outside entity’s involvement in a study and then contact the COI Committee, as described in the procedures below.
- If a COI arises because certain personnel listed on a human subjects protocol have a conflict of interest or outside activity that must be managed, the investigator can remove any conflicted research personnel from a study and then contact the COI Committee, as described in the procedures below.
Procedure for Reducing or Eliminating Conflicts of Interest
- Determine which of the above approaches to take and then send a brief
letter summarizing how you propose to resolve the potential conflict
of interest to the COI Committee through its staff.
Attach a copy of the updated Outside Activities Report or describe the
proposed change(s) to your protocol(s).
- The COI Committee reviews your submission.
- The COI Committee responds to your submission.
- If the COI Committee determines that you have adequately
resolved the potential conflict of interest situation, it will notify
you in writing and inform the IRB that reviews your affected protocol(s)
of its decision.
- If the COI Committee is unable to make a determination,
a COI Committee member may contact you for further information or
with suggestions about resolution strategy.
- If you propose to address potential conflicts of interest by revising your protocol(s), and the COI Committee determines that the proposed changes will eliminate potential conflicts of interest, you will need to submit a Change of Protocol form to the IRB after receiving notice from the COI Committee.
Note: At the time of a protocol’s next continuing review by a UW-Madison IRB, the protocol cannot be approved until any potential conflict of interest situations are resolved.