Students conducting research that involves human subjects must obtain IRB approval prior to beginning their research. This applies to experiment-based research as well as survey, interview, or observation-based research.
What is IRB?
The Institutional Review Board (IRB) is charged with reviewing all proposed research projects that involve human subjects to ensure the research is conducted ethically and that appropriate measures are built in for obtaining consent and informing subjects of potential risks.
Who needs to apply?
ALL projects involving human subjects must file for approval through the IRB office. This includes experiment-based research (for example, biomedical, exercise physiology, experimental psychology, etc.) as well as interview, survey, or observation-based research (for example, education, sociology, community-based participatory, etc.).
How do I apply for Approval?
Students should visit the IRB website (http://www2.montana.edu/irb/) to obtain the appropriate documents, and submit them by fax, mail, or in person to the campus IRB office (please note, an electronic submission system is currently being developed – watch for updates on the IRB website). There are 3 levels of approval:
- Exempt: This level of approval requires review by the IRB chair. This level is appropriate for projects that involve essentially no risk to adult subjects capable of giving informed consent.
- Expedited: This level of approval involves the IRB chair and two committee members. This level is appropriate for projects that involve minimal risk to adult subjects. This may also be appropriate for minimal risk projects involving subjects from vulnerable populations (for example, minors, or instances where there may be a language barrier).
- Full: This level requires review and approval by the entire IRB committee. This level is appropriate for projects that involve potentially significant risks to subjects (health risks, employment risks, etc.), work with vulnerable populations (minors, instances where there may be a language barrier, etc.), and/or investigate sensitive topics (collecting identifiable health information, criminal records, inquiring about illegal activities, etc.).
If you have any questions about which level of approval is most appropriate for your project, please contact the IRB Office at 994-6783. Be sure to review applicable IRB documents with your faculty mentor prior to submitting them to the IRB office.
What is the timeline for review?
Exempt reviews are typically turned around within a few days, as they only require review by the chair. Expedited reviews may require 1-2 weeks from the time the IRB office receives your documentation. Full committee reviews are scheduled once a month (typically the third Thursday of each month – application materials are due to the IRB office one week in advance), with notifications going out within a week after the review. Keep in mind, you may be asked to submit revisions, clarifications, or additional documentation prior to final approval, which may require additional time for the overall review. Applicants must also complete CITI training prior to approval, so please factor training time into the overall review schedule. Since USP also requires CITI training for funded projects, we advise students to review theRCR page or contact the USP office in advance to determine which CITI training module would be most appropriate for their project.
We recommend that you begin the IRB process at the same time you apply for funding to ensure timely review of your materials. You DO NOT have to wait for USP approval in order to begin the IRB process. While IRB approval will not guarantee USP funding, starting the IRB process early can facilitate a more timely start for projects approved for funding.