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COI Management Examples

External Entity Considerations

  1. Is the external entity sponsoring research at U-M (directly or via subcontract)?
  2. Is the external entity a U-M start-up company (intellectual property)?
  3. Is the external entity a vendor with whom U-M does business (procurement)?

Individual Considerations

  1. What is your role at the external entity?
  2. What is your role on the sponsored project?
  3. Do you supervise other faculty on the project?
  4. Do you supervise students or trainees on the project?

Research Activity Considerations

  1. Are students/trainees participating on the project?
  2. Is the project in transition from one institution to another?
  3. Is there intellectual property associated with the project?
  4. Is the project purchasing something from the external entity?

COI Situations

Conflict of interest (COI) situations may be complex because three (3) elements, the external entity, the U-M employee, and the research project/activity combine to create a unique situation.  A conflict situation often includes one or more of the following factors:

  • Subcontract
  • Intellectual Property
  • Student/Trainee participation on the project or employment with the external entity
  • The U-M employee has a role (e.g., consultant, board member, president, officer, or other employment) in the external entity 
  • The U-M employee has ownership, or other financial interest, in an external entity

Management of a COI situation will vary depending on the percieved level of risk to the U-M employee, U-M research, and/or University.  

Management Example:

Professor Jane B holds equity in a company.  The company has a sponsored (e.g., NIH or SBIR/STTR) award and wishes to subcontract a portion to U-M under her direction.  U-M will provide support for a GSRA, whom Professor B supervises, to work on the project.  Professor B reported her outside interest in the external entity in M-Inform. 

Level of riskSignificant COI.  Due to Professor B's ownership in the company, combined with her role as Principle Investigator (PI) on the subcontract to U-M, and her oversight of a student participating on the project, the potential for undue influence is high.

Management options:  

  1. Change the PI on the subcontract to minimize the conflict and report the stuatory conflict to the U-M Board of Regents (per the State of Michigan COI Statute).  Appointing a different U-M faculty member, with no connection to the company, as the PI provides oversight of the research without conflict of interest.  
  2. Protect the student by appointing another faculty member, with no connection to the company, to supervise the student's research (e.g., serve as thesis advisor) or act as an ombudsperson.

Management Variations:

If Professor B becomes a co-investigator on the subcontract or remains the PI on the project (least desirable option) due to needed expertise for the research, additional management conditions would likely include:

  • Appointment of a monitor, with no connection to the company, for financial and/or reporting oversight of the project at U-M
  • Restrictions on making decisions (e.g., purchasing, etc.) for the project as a representative of the external entity (sponsor)
  • Disclosure of her connection to the company to the project team (e.g., lab staff, students) 
  • Reduction or elimination of the responsibility to annually evaluate staff or key personnel involved in the project at U-M

 

Questions?

For questions about U-M's COI review and management processes, email COI.Support@umich.edu.