Key Definitions
- Outside Activity, Relationship, Interest ("outside activity"): Outside interest, activity, or relationship with an entity/organization external to U-M that relates to an individual’s institutional responsibilities, and applies to the individual and his/her family members.
- An outside interest is related to an individual’s institutional responsibilities when it relies upon the same expertise that an individual uses to carry out his or her institutional responsibilities, or when it has the potential to influence the duties that the University considers part of the work it pays or otherwise engages the individual to do.
- Outside activities should be reported in an individual’s M-Inform disclosure.
- Conflict of Interest (COI): Exists when a COI Office determines that an outside activity could directly and significantly affect, or be affected by, the design, conduct, or reporting of the research.
- Financial COI (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of a research project.
- Statutory COIs: Exists when the University plans to enter into a financial contract with a company in which an individual holds a relationship that meets the requirement for review and approval by the Regents. (RAR = Regental Action Request)
Note COI Offices will review statutory COIs to determine if formal management is required.
See the Outside Activity Disclosure Guidance for details.
COI Requirements
- All investigators must disclose in M-Inform annually.
- An investigator must have a current disclosure (within the last 365 days) on file in M-Inform to sign a PAF, Award, or Award Change Request.
- COI Office review must be completed before funding is released.
- COI Office submits an FCOI report to the sponsor as required.
- COI Office performs an annual review in M-Inform for projects where the sponsor follows PHS FCOI guidelines.
COI Indicators in PAF
If any of the following COI indicators are present, ORSP should alert the COI office to perform a review.
Note Click the links in the table below to view screenshots located at the end of this document.
COI Indicator | What Triggered the Indicator | Link(s) to Screenshot(s) |
---|---|---|
PI indicated COI | When signing the PAF, the PI selected Yes on the COI question. | |
ORSP indicated COI | ORSP or COI identifies a COI that was not noted by the PI. | |
PHS FCOI Regulations Apply | The project is funded by a sponsor that follows the PHS guidelines and requires COI review annually. | |
RAR flag/note | Someone at U-M has a relationship with the sponsor that may require a RAR and/or COI review. | |
CAR exists | A CAR was opened automatically or manually for one of the above reasons; check with COI office if reason unknown. |
PHS PAF Requirements
- All investigators need an M-Inform disclosure on file upon submission of the proposal and investigator disclosures must be updated as of July 1 each year.
- COI review must be completed before funding is released.
- COI notifies ORSP if an FCOI report needs to be submitted to the sponsor.
- ORSP notifies COI to perform an annual review during the progress report time.
- FCOI reports are submitted by ORSP annually for the duration of the grant.
Screenshots
Review COI Status
PAF Workspace: RAR PAF note under Status map
"Sponsor requires COI review. ORSP will seek COI and Regental approval when needed."
PAF Workspace: PHS Regulations Apply message under State
PHS FCOI Regulations Apply
PAF Summary: UM Investigator Signatures
Manage Factors: ORSP-Related Factors
Last Updated:
Friday, December 6, 2024