Human Research Protection Program (HRPP)
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
- Protocol Review Committee(link is external) (PRC), part of the U-M Rogel Cancer Center
- Michigan Clinical Research Unit (MCRU), part of U-M MICHR (U-M Authentication required)
- Michigan Medicine Clinical Engineering (formerly BEU)
- Rogel Cancer Center Tissue and Molecular Pathology Core(link is external)
See the Operations Manual – Part 2: Organization of the HRPP for full details.
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.
HRPP ADVISORY COUNCIL
The HRPP Advisory Council advises the U-M Institutional Official and Deputy Institutional Official with regard to HRPP and IRB policies and procedures, and identifies priority areas for improvement to enhance the effectiveness of the program. The HRPP Advisory Council includes representation from a broad base of the research community.
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
Minimizing risk to subjects and protecting subject rights and welfareSee the Operations Manual – Part 6: Roles & Responsibilities for full details.
U-M HRPP Key Information
The University of Michigan has an approved Federalwide Assurance (FWA) with the U.S. Department of Health & Human Services (HHS). U-M’s IRBs are also registered with the HHS Office for Human Research Protections (OHRP).
U-M FWA Number: FWA00004969
U-M Institution/Organization Number: IORG0000144
The expiration date for the assurance changes regularly. If you need the expiration date, please visit OHRP’s registration database(link is external), enter the FWA Number above, and click “Search.”
| U-M IRB | IRB Registration Number |
| U of Michigan IRBMED A-1 #1 | IRB00000244 |
| U of Michigan IRB-HSBS – Health Science – Maize #3 | IRB00000245 |
| U of Michigan IRB-HSBS – Behavioral Science – Blue #3 | IRB00000246 |
| U of Michigan IRBMED B-2 #6 | IRB00001995 |
| U of Michigan IRBMED A-2 #7 | IRB00001996 |
| U of Michigan IRBMED B-1 #8 | IRB00001999 |
| U of Michigan IRB #1 – IRBMED C-1 #9 | IRB00005467 |
| U of Michigan IRB #11 – IRBMED C2 #11 | IRB00012211 |
Human Subjects Links
Questions?
To ask a question, express concerns, or provide suggestions about human research protections at U-M, please send a message to [email protected].
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.