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

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

Conflicts of interest 4 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

Conflicts of interest 5 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

Conflicts of interest 6 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.

Conflicts of interest 7 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

Conflicts of interest 8 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

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

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

Conflicts of interest 11 Developed by: U-MIC Conflicts of interest in human subjects research

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