Research Compliance and Tech Transfer

External Reviews

The University of Montana IRB will conduct reviews of appropriate, external, human subjects research proposals on a fee-based schedule. 

When an investigator is not engaged with the University of Montana as an employee or student for the purpose of conducting a research project involving human subjects, that project will be considered external and charged a fee regardless of the for-profit or non-profit nature of the project, investigator, or investigator’s company or agency. 

The UM IRB will only conduct external reviews of proposals for which it is qualified in terms of adequate experience and subject expertise. The IRB reserves the right to accept or decline a request for review for any reason. In most cases, the IRB authorizes the IRB Director to make this decision, but accepting or declining review will in some cases be determined by the Committee. The UM IRB will review proposals at the Full Board, Expedited, and Exempt levels of review as is appropriate to the complexity and risk level of the proposal.    

UM IRB may request additional information or evaluate protocols via Post Approval Monitoring (PAM) at any time for any level of review. External entities are responsible for timely reporting of all IRB updates, including but not limited to research amendments, current personnel, and adverse events. 

External Review Fee Schedule

The fees are assessments of costs associated with study reviews conducted by the IRB and are charges for services rendered. The initial review fee also includes access to UM’s CITI account for any human subjects training that the investigating team may need. Fees are due and payable upon submission to the IRB for initial, continued, amendment or closure review. Checks are payable to the University of Montana. 

Fees are non-negotiable and non-refundable. Because the IRB office commits its resources appropriate to each level of review, fees are due in full from the applicant regardless of subsequent conduct of the study, including disapproval by the IRB or early termination by the investigator or sponsor. Fees are subject to change at any time without notice. Additional services may incur added fees not listed here. 

UM IRB Internal Review Eligibility and Collaboration 

UM IRB strongly encourages external collaborators to partner with UM faculty, staff, and students for the mutual benefit of all parties. To be eligible for internal review (without external review charge or administrative fees), the human subject research project must meet one of the following conditions:  

1. The Principal Investigator must be a UM faculty or staff member who is actively participating in the human subjects research project. Such participation must have a direct connection to the role of the UM researcher and fulfill the UM academic objectives, research, or job role/responsibilities of the individual as applicable. Participation means that the UM PI has a role in research and will perform one or more of the following activities: 
   • Design research 
   • Conduct research 
   • Analyze research data 
   • Report research results 
   • Publish or present research findings 
   • Work with human subjects: 
   • Interact with subjects in any medium 
   • Obtain consent from subjects 
   • Collect personally identifiable information (PII) 
   • Gather or manipulate biospecimens 
2. UM is receiving research funding though the Office of Sponsored Programs for the work – funding includes:  
   • Grant 
   • Contract 

Please note that UM faculty affiliates are not University employees. Affiliates may collaborate with full-time faculty, where a full-time faculty member serves as the Principal Investigator (PI) and the faculty affiliate serves as a co-PI. Faculty affiliates may also request IRB review as an external researcher on the fee-based schedule above.

Intellectual Property and Technology Transfer 

Externally reviewed projects are not subject to the University of Montana’s intellectual property rights and, therefore, are not subject to its licensing policies. Any intellectual property that results from externally-conducted research is subsequently owned by the external investigator(s), company, or agency. 

Contact

Inquiries should be directed to the UM IRB office at irb@umt.edu or 406-243-6672. 

Payment 

Make check(s) payable to: University of Montana