IRB Board meeting minutes

1. 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. Developed by: U-MIC

2. IRB Board meeting minutes Developed by: U-MIC University of Michigan IRB Collaborative

3. Institutional Review Board IRB board meeting minutes meeting minutes • attendance • actions • votes • for and against • abstention • changes to a study • discussion • separate deliberations • alternate members • approval periods(initial and continuing review) • conflicts of interest • required determinations • waivers or alterations • research involving pregnant women,fetuses, and neonates • research involving prisoners • research involving children • HHS-regulated research • removal or change to HHS consent • risks • alternative procedures • FDA-regulated research • SR and NSR determinations or disapproval Developed by: U-MIC

4. IRB board meeting minutes IRB regulatory staff take minutes check for accuracy forward to board members IRB members check for accuracy vote to ratify Developed by: U-MIC

5. IRB board meeting minutes Oversight • within the University • outside the University • HHS • FDA • OCR • AAHRPP federal agencies audits accrediting agencies accreditation reviews Developed by: U-MIC

6. IRB board meeting minutes IRB members • check for accuracy • read before voting to approve • members’ own reviews • complex discussion Developed by: U-MIC

7. IRB board meeting minutes IRB board meeting minutes Developed by: U-MIC

8. Brian Seabolt IRBMED thank you. Developed by: U-MIC