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Human Research Protection Program (HRPP)
Institutional Review Boards (IRBs)
As part of the HRPP, the primary goal of the Institutional Review Board (IRB) is to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Michigan.
COVID-19: Pause in effect for some face-to-face human subjects research through May 1, 2020. Review the following for details:
- COVID-19 Research Operations - Research Involving Human Subjects FAQs (UMOR)
- IRB-HSBS: COVID-19 Guidance
- COVID-19 pause: Guidance on Updating Clinical Trial.gov Status (ORCR and UMMS Regulatory Affairs)
The Human Research Protection Program (HRPP) is an institutional-wide program coordinated by the University of Michigan Office of Research (UMOR) and composed of the executive officers, research review committees, and other entities that are responsible for protecting the rights and welfare of participants in research conducted or reviewed by the U-M.
HRPP Components
Oversight Units
- Institutional Review Boards (IRBs)
- Office of Research Compliance Review (ORCR)
Research Review Units
- Institutional Biosafety Committee (IBC)
- Conflict of Interest Review Committee (COI-UMOR, MEDCOI)
- Human Pluripotent Stem Cell Oversight Committee (HPSCRO)
- Radiation Policy Committee (RPC), part of U-M Environmental Health & Safety (EHS)
- Investigational Drug Service (IDS), part of the U-M Hospital and Health Centers
- Comprehensive Cancer Center (UMCCC)
- Michigan Clinical Research Unit (MCRU), part of U-M MICHR
- Michigan Medicine Clinical Engineering (formerly BEU)
- Tissue Procurement Core (TPC)
See the Operations Manual - Part 2: Organization of the HRPP for full details.
Researcher Roles & Responsibilities
As a U-M investigator or research staff working on a human subjects study, you are expected to following the federal, state, and university policies regarding the protection of human subjects. The HRPP Operations Manual outlines the U-M policy in detail. At a high-level, investigators and research staff are responsible for:
- Minimizing risk to subjects and protecting subject rights and welfare
- Securing IRB and other departmental or institutional regulatory approvals in advance of the research
- Obtaining and documenting informed consent
- Disclosing conflicts of interest
- Complying with sponsor-specific requirements as applicable (e.g., FDA requirements)
- Completing applicable training for the protection of human research subjects
See the Operations Manual - Part 6: Roles & Responsibilities for full details.
Questions?
To ask a question, express concerns, or provide suggestions about human research protections at U-M, please send a message to hrppumich@umich.edu.
Contact information for the Research Review Units can be found on their respective websites. For UMHS Clinical Engineering services or consultation regarding the use (e.g., selection, safety, maintenance) of investigational devices in human subjects research, call 734-615-3502.