What is the MDHHS Institutional Review Board and What Activities Need MDHHS IRB Review?

The Michigan Department of Health and Human Services
Institutional Review Board

For the Protection of Human Research Subjects

The MDHHS Institutional Review Board (IRB) is part of the Human Research Protections Program for the Michigan Department of Health and Human Services. The MDHHS IRB protects the rights and welfare of people involved in research supported by the department. The IRB does that by reviewing research proposals made to the department, and approving those proposals only if they are designed to:

  • Respect research subjects;
  • Have greater potential benefit than potential risk; and
  • Be fair and just in the selection of research subjects

The MDHHS IRB also monitors approved research and responds when noncompliance, severe adverse events, or unanticipated problems involving risks to subjects or others occur during research. The regulations guiding the MDHHS IRB include the “Common Rule” regulations at 45 CFR Part 46, and the U.S. Food and Drug Administration Regulations at 21 CFR Parts 50 & 56.

Most programs and activities MDHHS is involved in are not research and do not require IRB review.

If an activity includes a research component, if humans are the subjects of that research, and if MDHHS is engaged the research, then the MDHHS IRB must review and approve the activity before MDHHS can be involved in the activity.

The MDHHS IRB developed a decision guide to help researchers and MDHHS staff understand when an activity might require IRB review under the 2018 requirements of the Common Rule regulations.

It is not always easy to know when an activity requires MDHHS IRB review. It is important, however, that no human subjects research supported by the department occur without MDHHS IRB approval. If there are ever questions on this topic, please contact the MDHHS IRB.

January, 2019