2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

3. COLLABORATOR AGREEMENTS IRB Authorization Agreements (IAA) Individual Investigator Agreements (IIA) Collaborating Institution Agreements (CIA) Developed by: U-MIC University of Michigan IRB Collaborative

4. Collaborator agreements 3 Developed by: U-MIC Federalwide Assurance (FWA) OHRP-approved assurance of compliance institutions engaged in human subjects research not exempt conducted or supported by any HHS agency Assured institution may extend FWA to cover collaborating individual collaborating institution minimizes regulatory burden reduces duplicate review

5. Collaborator agreements 4 Developed by: U-MIC Requirements apply to regulated, non-exempt human subjects research engaged collaborators receive direct HHS award obtain consent collect data through interaction/intervention obtain subjects individually identifiable private information

6. Collaborator agreements 5 Developed by: U-MIC Types of collaborator agreements IRB Authorization Agreements (IAA) Individual Investigator Agreements (IIA)

7. Collaborator agreements 6 Developed by: U-MIC IRB Authorization Agreements (IAA) involves two or more institutions that hold FWAs UM may use IAA to accept oversight (UM as IRB-of-Record) to cede oversight to external institution

8. Collaborator agreements 7 Developed by: U-MIC Individual Investigator Agreements (IIA) used to provide oversight for external collaborators not affiliated with assured institution may be faculty or students at non-research institution hospital college UMOR determines whether UM is willing to oversee individual collaborator. separate IIA for each collaborator

9. Collaborator agreements 8 Developed by: U-MIC Used only at the University of Michigan: Collaborating Institution Agreements (CIA) research is not federally sponsored there are multiple non-assured collaborators Single qualified individual at non-assured institution holds responsibility for oversight of engaged collaborators.

10. Central IRBs 9 Developed by: U-MIC Collaborator agreements IRB Authorization Agreements (IAA) Individual Investigator Agreements (IIA) Collaborating Institution Agreements (CIA)

11. THANK YOU. Adam Mrdjenovich IRB-HSBS Faith Penix Judy Birk Brian Seabolt IRBMED 10 Developed by: U-MIC