PHS Regulation Change: Financial Conflict of Interest. How does it impact our unit? <Date>. Agenda. PHS Regulation Outside Interest Disclosure Who When Where System Information M-Inform Unit Information Resources. PHS Regulation Change.
How does it impact our unit?
To ensure objectivity in research, new PHS Financial Conflict of Interest regulations will be implemented on 08/24/12.
Objectivity in research = the
design, conduct, and reporting of the research is not biased by conflicting financial interests
How do I comply with the regulation?
What I will do:
How U-M will help me:
By providing a comprehensive disclosure system
By enhancing management tools for COI committees: input, review, tracking, and archiving
By including tracking for research personnel after award
By establishing a means for public reporting
By offering training
U-M’s annual disclosure period begins July 1.
Sponsored by the Medical School
An outside interest, activity, or relationship that relies upon the same expertise as an individual’s ability to carry out his or her institutional responsibilities. Also, any interest, activity, or relationship that has the potential to influence the duties that the University considers part of the work it pays or otherwise engages an individual to do.
What can I expect if I answer “Yes”?
Points to remember
U-M can’t award a PHS project until all disclosures are completed, evaluated, and (if a conflict is identified) managed.
Three (3) systems will work together to record, report, and manage COI.
Capture data on PAF in eRPM
Manage in Conflict Admin
Disclose in M-Inform
PAF captures project personnel who need to disclose/have disclosed
M-inform sends disclosure status to eResearch Proposal Management (eRPM)
Who needs to disclose? Principal Investigators, Project Directors, Senior/Key personnel, and other investigators identified as responsible for the design, conduct, or reporting of the research (i.e., not simply working on, or engaged in, the project).
E.g., Those who design the study protocol or methodology; analyze and interpret data or results.
Want more information?
Ask our Unit COI Contact:
<insert name & contact info here>