Resolving conflicts of interest

1. 1
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2. CONFLICTS OF INTEREST
in human subjects research
Developed by:
U-MIC
University of Michigan IRB Collaborative

3. Conflicts of interest
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Developed by:
U-MIC
Conflict of interest
• financial interest that
creates potential for bias
• Possibility of profit
may affect researcher’s
judgment.

4. Conflicts of interest
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Developed by:
U-MIC
UM conflict of interest policies
• safeguard
• students
• patients
• public trust in unbiased research
• ensure compliance
• policies
• regulations
• University of Michigan conflict of interest committees
 Medical School Conflict of Interest Board (MEDCOI)
 UMOR Conflict of Interest Committee

5. Conflicts of interest
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Developed by:
U-MIC
Conflict information shared within eResearch
• Appropriate study team members indicate whether
they have related outside interests or relationships.
• Example: Study team member
serving as consultant to sponsor
• To review a study team
member’s answer,
click name
• on study team list
• in eResearch section 1.3

6. Conflicts of interest
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Developed by:
U-MIC
If study team member
has outside interest
• COI Committee determines
whether interest represents
conflict.
• If not, COI Committee conveys finding in its determination.
• If so, COI Committee creates plan to address conflict.

7. Conflicts of interest
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Developed by:
U-MIC
Conflict may be managed by
• disclosure to
• study team
• subjects
• IRB
• public
• Example: financial relationship valued under $5,000
• communicated with COI determination

8. Conflicts of interest
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Developed by:
U-MIC
Conflict may be managed by
• further steps
• Example: Conflicted researcher may be excluded from
informed consent process.
• Conflict Management Plan
• accessed in eResearch
• investigator’s detail page
or
• Documents tab
 reduces or eliminate potential
for bias
 eliminates real or perceived
coercion or other issues affecting
informed consent

9. Conflicts of interest
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Developed by:
U-MIC
M-Inform
• to access Conflict Management Plans

10. Conflicts of interest
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Developed by:
U-MIC
M-Inform
• to open Conflict Management Plans

11. Conflicts of interest
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Developed by:
U-MIC
Conflicts of interest
in human subjects research
http://research.umich.edu/conflict-of-interest/

12. THANK YOU.
June Insco
Regulatory Affairs
Brian Seabolt
IRBMED
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Developed by:
U-MIC