Proposal Management: Conflict of Interest Guide

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 Indicators in PAF

If any of the following COI indicators are present, ORSP should alert COI 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.	Review COI Status, PAF Summary, Manage Factors
ORSP indicated COI	ORSP or COI identifies a COI that was not noted by the PI.	Review COI Status, Manage Factors
PHS FCOI Regulations Apply	The project is funded by a sponsor that follows the PHS guidelines and requires COI review annually.	Main PAF under State
RAR flag/note	Someone at U-M has a relationship with the sponsor that may require a RAR and/or COI review.	Manage Factors, Main PAF under Status Map
CAR exists	A CAR was opened automatically or manually for one of the above reasons; check with COI office if reason unknown.	Review COI Status, Manage Factors

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.

COI Administrative Record (CAR) States

ORSP should NOT activate a PAF until the COI review is complete. Once complete, the CAR will appear in a finalized* state and a project note will be posted in eRPM. ORSP should put PAFs on hold until the COI review is completed for that review cycle. An approved RAR does NOT mean that the COI review is complete.

CAR State	Description	ORSP Action
Open	The default status when a CAR is initially created (usually CARs are auto-created and may sit in this state for a while).	ORSP notifies COI to review.
Under Review	The COI office has started the review on a project in this state - RARs may be requested from ORSP in this state.	COI review has begun; ORSP can request an update from COI.
*No Conflict Found	The COI office performed a review and no conflict was found on the project (mainly used for PHS reviewed projects).	If PHS, ORSP notifies COI to review annually.
*No Review Required	No outside interests were disclosed, project was marked COI in error, etc.	If PHS, ORSP notifies COI to review annually.
*Review Complete	The COI Committee has completed a review and all documentation (e.g. management plan, RAR, and/or FCOI report) is complete.	For PHS, ORSP requests COI to review annually.
* Closed – Conflict Eliminated, Withdrawn, Not Funded, Project Complete	COI is under the assumption that the COI was eliminated, or the project was withdrawn, not funded, or completed.	ORSP alerts COI if the project was funded or is activated.
Under Annual Review	Projects with a COI that are under management and under an annual review (these projects may be PHS, but the COI is driving this status).	ORSP requests an update from COI.