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

The mission of the UM IRB is to ensure the protection of human participants in research, maintain federal regulatory compliance, and facilitate research at The University of Montana.

UM policy requires that all projects involving human subjects research be approved by the 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.

Human Subjects Protection Course

As federally mandated and required by the UM IRB, all researchers and individuals involved in project activity must complete a self-study course in human subject protection. This requirement may be satisfied by taking one of the three courses below within the last three years.  The CITI course is the most comprehensive and would also be an excellent resource for research methods classes.  Please note that researchers pursuing sponsored projects may need to complete additional training or other compliance requirements.

• OPTION 1:CITI (Collaborative Institutional Training Initiative),  After selecting The University of Montana from the drop-down menu and setting up a username/password, follow the directions to select the appropriate curriculum for your research with humans subjects.  Questions?  Contact Paula Baker, 243-6672.
• OPTION 2: Protecting Human Research Participants, NIH Office of Extramural Research. Complete the requested registration form and proceed. Print and keep the "Certificate of Completion" as the date completed is required on the UM Checklist.
• OPTION 3: The University of Montana: Online Research Ethics Course. Take three sections: "Section One - Ethical Issues in Research: A Framework;" Section Two - Interpersonal Responsibility;" and, "Section Six - Human Participation in Research." Print and keep the assessment results for each of the three sections as the date completed is required on the UM checklist.

Helpful URLs

• HHS Office for Human Research Protections (OHRP)
• NIH Policy and Guidelines on the Inclusion of Children As Participants In Research Involving Human Subjects
• Select Survey, a UM web tool, makes it easy to develop, administer and analyze online surveys (When using any online survey software, include a statement of confidentiality in your IRB application materials)
• Gunning Fog Index - ("the easiest to use and probably the most popular readability index")

Contact

Institutional Review Board for the Protection of Human Subjects
Research & Creative Scholarship, University Hall 116
The University of Montana
Missoula, MT 59812
Phone 406-243-6672 | Fax 406-243-6330
IRB@umontana.edu