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

 

  IRB Forms

Welcome Dr. Michaela Shifley, UM's IRB Manager

The Office of Research and Creative Scholarship and UM’s Institutional Review Board (IRB) are pleased to announce that Michaela Shifley, Ph.D. has agreed to serve as UM’s IRB Manager. As IRB Manager, Dr. Shifley will be responsible for the operation of UM’s human subjects research program. All research involving human subjects, including survey research, must pass an intensive ethical review to ensure compliance with federal law and university policies.
 
Originally from Laurel, Montana, Dr. Shifley completed her doctorate in anthropology at UM, focusing on how moccasin design, art, and construction reveal the economic, cultural, and spiritual contributions of Native American women. Dr. Shifley has also played an important role in UM’s ongoing efforts to repatriate objects of cultural patrimony to Montana tribal governments and museums. Dr. Shifley’s experience in these areas is a welcome resource to UM faculty that collaborate with indigenous partners to perform social and biomedical research. 

The IRB would also like to thank Dr. Paul Smith for his service as interim IRB Manager. Dr. Smith provided exceptional service to UM faculty, staff, and students conducting human subjects research during the search period. We are profoundly grateful for his support and dedication to UM research.

Dr. Shifley can be reached at michaela.shifley@umontana.edu or by appointment at her ISB 104 office. Please join us in welcoming Dr. Shifley to her new role at UM!

Research with Human Subjects in COVID-19 Conditions

The University of Montana is at Research Operation Level 0 as of February 25, 2022 (normal operations).  Please note that masks, social distancing, etc. may be required by the IRB when necessary to protect subjects that may be at heightened risk of contracting COVID-19.

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.

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 Science Building (ISB), room 104 (By Appointment Only)
IRB@umontana.edu

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