1. Exception for Informed Consent for Emergency Research and the IRB: Operationalizing It Ronald F. Maio DO, MS Director, Office of Human Research Compliance Review Professor, Emergency Medicine University of Michigan PRIMR 2007

2. Some Wolverine History 1997 –University of Michigan (UM) IRBMED endorses policy to not even consider EFICER. 2006 –UM IRBMED endorses policy to review EFICER 3 studies currently “in the works” Steps –Change in opinion/viewpoint –Specific procedures on processing the application

3. Specific Procedures? Pre-submission requirements? Special reviewer or committee assignment? Sequence of review? –Review science first? Verify study meets FDA requirements Then review community consultation/public disclosure Review complete package ? Guidance for investigators? Special post-approval monitoring?

4. What’s Been Done? Lots of stuff about community consultation Lots of stuff about community disclosure Very little on the specific process Special Committee formed –Develop recommendations –Present to IRB members and staff for discussion

7. UM IRBMED Process Investigator notifies IRB of intent and submits protocol Meets with Co-Chair Proposal submitted to IRB subcommittee –Members are function of study Investigator and subcommittee work together –Community consultation –Community disclosure IRB submission for approval to begin CC –Comments also made about the science

8. UM IRBMED Process (cont.) Community Consultation implemented Investigator and subcommittee develop report to IRB Report submitted to IRB IRB does complete review Investigator submits quarterly reports Caveat: Full Board IRB has final say Not Subcommittee

9. Recommendations to Investigators Review regs and guidance Review “Essential Questions” list Review the literature Consider including an investigator consultant One size does not fit all ANTICIPATE THIS IS NOT A SHORT PROCESS

10. Thank You