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 Level 1 as of May 4, 2020. Researchers wishing to resume face-to-face human research under an approved IRB protocol must receive prior clearance in writing from UM’s IRB Manager. Under Level 1 conditions, any such research will require both researcher and subject to wear personal protective equipment, including masks, gloves, safety goggles or glasses, and gowns, to reduce the risk of COVID-19 transmission. Any exceptions will be reviewed on a case-by-case basis. Please contact the IRB Manager before resuming human subjects research. Otherwise, the directives below apply until further notice.

All human subjects research that requires direct human-to-human contact should be halted until further notice. Study procedures that can be converted to an online methodology should be done so by submitting an amendment request to the IRB. Newly approved studies requiring direct participant interaction that have not yet begun recruiting should be postponed. Research that has been approved to be conducted virtually/remotely may proceed. Investigators with NIH-funded projects should refer to Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19.

At the current time, the UM IRB is continuing to review and approve research protocols, amendments, and continuing reviews that have been or will be submitted, including those submissions that require full board review. However, newly approved research may not begin enrolling participants unless doing so does not require direct participant interaction or, if enrolling participants where direct interaction is required, is only for a study with significant potential therapeutic benefit to participants.

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. The University's Federalwide Assurance number is FWA00000078, and its IRB Registration number is 00000854.

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

Contact

Institutional Review Board for the Protection of Human Subjects
IRB Office: Interdisciplinary Sciences Building 104
Phone: 406-243-6672
IRB@umontana.edu