MSU IRB External Review Eligibility

When MSU engages in an external review for human subjects research, the University is responsible for protocol oversight, providing and ensuring personnel training, maintaining ongoing amendments, arranging annual reviews, and managing adverse events as required by federal regulations. MSU also takes on the responsibility and risk for the care of human subjects. These activities require time and effort.

External Review Fee Schedule
Service
Fee
Exempt Initial Review 
$500
Expedited Initial Review
$1000
Full Committee Initial Review
$1500
Exempt Protocol Annual Maintenance (yearly fee; up to 5 years total coverage)
$200
Expedited Protocol Annual Maintenance (yearly fee; up to 5 years total coverage)
$350
Full Committee Protocol Annual Review (yearly fee; up to 5 years total coverage) 
$500

 

Conditions

  • Contact the MSU IRB with your proposal for initial consideration. MSU IRB reserves the right to decline any external request. Private sector IRBs are available to provide reviews.
  • MSU 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.
  • Fees are subject to change at any time without notice. Additional services may incur added fees not listed here.
  • Approvals will not be given until fees are paid.
  • External projects requiring clinical and/or medical oversight of human subjects will not be reviewed by the MSU IRB.

 

MSU IRB Internal Review Eligibility and Collaboration

MSU strongly encourages external collaborators to partner with MSU 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 have at least one of the below significant connection points with the University:

  1. MSU students, staff, and/or faculty are participating in the human subjects research project and are listed as project personnel on the IRB protocol. Such participation must have a direct connection to the role of the MSU researcher and fulfill the MSU academic objectives, research, or job role/responsibilities of the individual as applicable. Participation means that the MSU individual has a role in research and will perform one or more of the following activities:
    1. Design research
    2. Conduct research
    3. Analyze research data
    4. Report research results
    5. Publish or present research findings
    6. Work with human subjects:
      1. Interact with subjects in any medium
      2. Obtain consent from subjects
      3. Collect personally identifiable information (PII)
      4. Gather or manipulate biospecimens
  1. MSU is receiving research funding though the Office of Sponsored Programs for the work – funding includes: 
    1. Grant
    2. Contract

 

*Requests for internal IRB review that involve non-monetary benefits to MSU, other unique circumstances not covered here, or where no MSU personnel are involved may be considered at the discretion of the VPR-EDGE or designee.

*All collaboration requests must come from the MSU individual rather than the external entity, and the primary point of contact for MSU IRB communications will remain with the MSU individual on the project throughout the lifetime of the IRB protocol.

 

FAQs

Is my research project eligible for internal review by the MSU IRB?
Current MSU faculty, students, and staff

Yes, when the project is connected to a faculty or staff member’s role and responsibilities at MSU or the work progresses a student in their academic objectives.
 Emeritus or Retired MSU Faculty

No, individuals who are not under contract nor paid by MSU are not eligible for internal MSU IRB review. Submit a request for fee-based external review or collaborate with MSU.
Former Students/Alumni

No, submit a request for fee-based external review or collaborate with MSU.
Nonprofit Organizations

No, submit a request for fee-based external review or collaborate with MSU.
Local Corporation/Business

No, submit a request for fee-based external review or collaborate with MSU.
State of Montana Entities (DPPHS, OPI, etc.)

No, submit a request for fee-based external review or collaborate with MSU.
Fulbright Scholars

Depends –  Yes, if the aims of the study clearly fulfill the faculty’s MSU responsibilities or the student’s MSU academic objectives.
WWAMI Students

Yes, when the research advances the student towards their program objectives – human subjects research fulfills the aims of the WWAMI program.
Affiliate Faculty (USGS, FWP, etc.)

Depends – Does the research include a significant connection point with MSU? Does the research involve and benefit MSU or MSU employees/students?