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.

IRB BOARD MEETING MINUTES Developed by: U-MIC University of Michigan IRB Collaborative

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

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

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

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

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

THANK YOU. Brian Seabolt IRBMED 8 Developed by: U-MIC