Institutional Review Board (IRB) for the Protection of Human Subjects in Research

Research with Human Subjects in COVID-19 Conditions

The University of Montana is at Research Operation Level 1 as of August 26, 2021.  All human subjects research that involves face-to-face interaction within enclosed or indoor spaces, regardless of university or public health mandate status, is required to continue mask use, maintain social distancing, and sanitize all work surfaces and equipment. Subjects under the age of 5 are not required to wear masks, per MCCHD directives. Subjects and researchers should be screened for COVID-19 symptoms at the start of each encounter. All proposals for in-person research must include COVID-19 mitigation procedures. Please contact the IRB office with any questions.

About the IRB

The mission of the University of Montana (UM) Institutional Review Board (IRB) is to ensure the protection of human participants in research, maintain federal regulatory compliance, and facilitate research at the University of Montana.
Federalwide Assurance number = FWA00000078, expires 2/05/2024
IRB Registration number = 00000854, expires 7/22/2024

UM Policy 460 requires that all projects involving human subjects research be approved by the UM Institutional Review Board (IRB) when UM faculty, staff, or students are engaged in the research. Grant applications for these projects also must show evidence of IRB approval before they are processed by the Office of Research and Creative Scholarship.  Please contact us if you have any questions about your research.

Beginning May 22, 2015, the University of Montana IRB will conduct reviews of appropriate, external, human subjects research proposals on a fee-based schedule. See the IRB External Review policy.

Defining Engagement

In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. See the Federal guidance on engagement.

Is Your Project Human Subjects Research?

The UM IRB reviews projects in accordance with the Federal definitions of research and human subjects. For detailed clarification and examples, please refer to "Is your project Human Subjects Research?" Investigators should err on the side of caution and consult with the IRB to establish the status of their projects.

IRB Essentials

  • All research team members need to complete a Human Subjects Protection course before the IRB application can be approved (may be waived by the IRB Chair for some exempt projects).
  • The IRB review must be conducted before you involve human participants in your research, including any study advertisement or subject recruitment.
  • You need to have final, written IRB approval before you begin.  All consent forms and flyers must be approved, date-stamped, and signed by the IRB before being used.
  • If you do not have IRB approval for your research, your research project cannot be recognized by UM and, for students, may not be accepted to fulfill any academic requirements.
  • Except in very limited circumstances, the IRB cannot review research that has already been conducted.

Helpful URLs


Institutional Review Board for the Protection of Human Subjects
IRB Office: Interdisciplinary Science Building (ISB), room 104
Phone: 406-243-6672