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HUMAN RESEARCH PROTECTION PROGRAMS (HRPP) Developed by: U-MIC University of Michigan IRB Collaborative

HRPP 3 Developed by: U-MIC Human Research Protections Program (HRPP) emerged in early 2000s high-profile cases temporary suspension of research prominent academic institutions essential for ensuring human subjects protections

HRPP 4 Developed by: U-MIC Human Research Protections Program (HRPP) not limited to IRBs other offices with direct regulatory oversight university-wide, integrated system all those involved in research examples: study coordinators university leadership

HRPP 5 Developed by: U-MIC Human Research Protections Program (HRPP) University of Michigan HRPP’s central aims to protect the rights and welfare of research subjects compliance with applicable ethical and regulatory standards Belmont Report federal regulations (OHRP / FDA) Good Clinical Practice to help facilitate research throughout UM Members of research community should utilize UM HRPP offerings: resources support education

HRPP 6 Developed by: U-MIC Human Research Protections Program (HRPP) UM HRPP directed by UM Office of Research (UMOR) HRRP Director (the Assistant Vice President for Research) facilitates communication/coordination acts as liaison other contributors academic units involved in human subjects research IRBs (IRBMED / IRB-HSBS / IRB-Dearborn / IRB-Flint) Office of Human Research Compliance Review (OHRCR) Office of Research and Sponsored Projects (ORSP) Office of the General Counsel (OGC) executive and administrative leadership conflict of interest review committees (MedCOI / COI-UMOR) other research review and support committees Hospital Biomedical Engineering Unit (BEU) Investigational Drug Service (IDS) Michigan Institute for Clinical and Health Research (MICHR) Radiation Policy Committee (RDRC/SHUR) stakeholders across all above offices/departments all involved in UM research faculty staff students trainees

For more information about the University of Michigan HRPP: 7 Developed by: U-MIC

Thank you. Sana Shakour Avery Avrakotos University of Michigan AAHRPP Accreditation Committee Judy Birk Cindy Shindledecker Brian Seabolt University of Michigan Institutional Review Boards 8 Developed by: U-MIC