Welcome to the University of Montana IRB Office! Our mission is to protect the rights and welfare of human research participants. The IRB Office provides resources, training, oversight, and consultation to the UM human research community.

IRB review must be conducted before you involve human participants in your research, including any study advertisement, subject recruitment, or data collection. 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. The IRB cannot review research that has already been conducted. 

Human research studies requiring IRB review and approval must be submitted through the electronic submission system Cayuse Human Ethics (HE). Before preparing your application, please read through the information on this page to assess requirements and considerations for new studies and whether any additional reviews are required.

Below are some common questions and topics that come up when individuals new to the UM IRB Office are starting or joining research studies:

Preparing a New Study

First: Determine the Principal Investigator and Identify the Study Team 

Every research study requires a Principal Investigator (PI). A PI is the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research. Sometimes projects may have more than one PI. Other study team members may include Co-PIs, Faculty Supervisors, and Research Assistants.  

If you are joining the University of Montana from another institution and you plan to continue an existing research study, please email irb@umt.edu to discuss your ongoing research, determine whether the research requires review by the University of Montana IRB, and determine whether reliance agreements between UM and another entity are required.

Human Subjects Protection Training

All individuals engaged in human subjects research must be listed on the IRB application and are required to complete a human subjects protection training course. Currently, UM supports two different trainings: CITI (recommended), and the UM Online Research Ethics Course. Learn more about these trainings here. 

Trainings must have been completed within the last three years to be considered valid. Please note that Responsible Conduct of Research (RCR) courses do not fulfill the IRB course requirement.

Individuals Not Qualified to Serve as PI

As per UM policy, undergraduate students may not serve as the PI on any UM IRB study, but may serve as Co-PI when the PI is a faculty supervisor. Graduate students may serve as PI but must also list a faculty supervisor. Faculty affiliates are not UM employees and cannot serve as PI, but may serve as Co-PI when a full-time faculty member serves as PI. Please refer to the UM IRB Policies and Procedures manual for more information. 

Listing Collaborators Outside of UM

UM researchers often collaborate with external partners on human subjects research projects. These collaborators are required to be listed on your IRB application if they are engaged in human subjects research. If your collaborators are affiliated with an institution that has its own IRB (ex., another university, a hospital, etc.), a reliance agreement (LINK TO SPECIFIC SPOT ON IRB REVIEW PROCESS PAGE) may be needed if the protocol is Expedited or above. If your collaborators are not affiliated with an institution that has its own IRB, they will be required to complete an Individual Investigator Agreement. 

Second: Develop the Study Protocol 

Project information entered into the IRB application should be thorough and complete. Incomplete or inaccurate information is one of the most common reasons IRB applications get returned to PIs for revisions. Sources should always be cited within the application when relevant. 

Information requested by the IRB application includes, but is not limited to: 

• The purpose of the research and why human subjects must be involved, including any relevant hypotheses, study design, and study location information.
• Project funding, especially if federal funding sources are involved. A note on subcontracted research: when a UM researcher is engaged in a subcontracted portion of a non-exempt human subjects research study, regardless of whether that portion considered by itself would meet an exemption, the subcontracted researcher must obtain IRB review and approval for that activity.
• Identification of the participants, including inclusion/exclusion criteria, the number of people enrolled, their ages (or an age range), whether minors are involved, and/or whether participants are members of a physically, psychologically, or socially vulnerable population. You will also be asked to describe the means by which the subject's personal privacy will be protected, and the confidentiality of information maintained
• The informed consent process, including copies of any informed consent forms being used. The IRB highly recommends that researchers use our informed consent templates to customize their own forms. 
• Recruitment/selection procedures, including copies of all flyers, advertisements, and other recruitment materials that may be used. 
• A precise and explicit description of the activities the subjects will perform, including the instrumentation and procedures to be used and kinds of data or information to be gathered. Provide enough detail so the IRB will be able to evaluate the intrusion from the subject's perspective.
• The benefits of the research, if any, to the human subjects and to scientific knowledge. If the subjects will not benefit from their participation, so state.
• The risks and discomforts to which the subjects will be exposed. Such deleterious effects may be physical, psychological, professional, financial, legal, spiritual, or cultural. Some research involves violations of normal expectations, rather than risks or discomforts; such violations, if any, should be specified. It is highly unusual to state there are no risks or discomforts. Also include a description of how each deleterious effect or violation will be minimized.

Additional application sections will be required if study teams are: conducting international research, conducting research on an Indian reservation and/or specifically recruiting a Native American population, and/or are collaborating with external researchers outside of UM. 

Third: Ensure All Necessary Reviews and Approvals are in Place

Depending on the particulars of your research study, you may need to secure additional reviews, approvals, or notifications from other units or organizations prior to initiating your research. Studies that involve external funding must have appropriate contracts and agreements in place with the Office for Sponsored Programs. 

Please note that any researchers working with human blood, body fluids, genetic material, and/or tissue are required to submit a UM Institutional Biosafety Committee (IBC) application. 

It is the Principal Investigator’s responsibility prior to conducting research to determine what, if any, permissions are required. Certain UM departments, campus buildings, schools, external organizations, and other sites may require researchers to obtain site permission before conducting research. Some examples include, but are not limited to: 

• UM Athletics – researchers are required to obtain permission from the UM Athletics director prior to conducting any research that specifically recruits UM student athletes, as per NCAA regulations.
• Other UM auxiliary sites, such as the University Center, clinics, and the ASUM Daycare Center. 
• K-12 schools, preschools, and daycare centers – permission must be given by either a principal or the superintendent. 
• Corporate and privately-owned businesses, as well as non-profit agencies such as the YMCA, YWCA, or food banks. Hospitals, clinics, and other healthcare organizations are included as well. 
• Public locations where there is an expectation of privacy, such as bathrooms. 
• Trailheads on Federal Land (A National Park Service (NPS) research permit is required for all types of research). 
• Indian reservations. 

Site permission can be submitted to the IRB via a written hard-copy or email letter. 

Fourth: Gather Documents and Support Information for Your Submission

Be prepared to attach several files to your submission.  These may include informed consent forms, recruitment materials, survey instruments, interview questions, site permission letters, and more. All participant-facing materials require prior IRB review and approval. When attaching each file, name it as you want it to appear in the IRB determination letter. 

Fifth: Submit Your Application and Wait for IRB Review

See our IRB Review page for more information about deadlines, review times, review types, and full committee meeting dates.