Do I need to submit an IRB Application?

All research studies involving human participants conducted by MSUB faculty, staff, or students as part of his or her university responsibilities are subject to IRB review and must be submitted to the IRB.  This includes research that involves survey instruments, such as questionnaires.  Feel free to contact our office if you have any questions on what you should submit.

How do I submit my IRB application?

You have a couple of options:

  • We recommend that all students use our DocuSign form to submit applications.
  • If you are unable to use DocuSign, you can drop off a physical copy to McMullen 205 or send your IRB application to irb@msubillings.edu.

Can I apply to the MSUB IRB if I am not an MSUB student or employee?

Yes, but you must have an MSUB Co-Principal Investigator.

How long do I have to wait to receive an answer from the IRB?

Once the GSP office receives the application, we send it to the IRB Chair who has 10 working days to review. If the Chair decides the application needs full review, the process could take up to a month.

 All applications are emailed to the Chair with the PI (principle investigator) and faculty sponsor cc’d on the message.  This email is sent off within a day of the office receiving the application, so if you do not receive that email after that initial time period, please contact us.

What are the differences between an "exempt," "expedited," or "full" review?

Exempt: Must fall into six federal-defined exempt categories (such as anonymous surveys or retrospective chart reviews).  Applications that might be considered exempt must still be submitted to the IRB.

  • Expedited: Research subjects are identified and/or their responses might put them at some risk, which could fit anywhere in the range from physical to emotional to employment.
  • Full: Research with greater than minimal risk or that does not fit into exempt or expedited categories must be fully reviewed by the IRB.

What are some good examples of IRB applications?

 The following IRB applications were approved by the PIs to be used as examples. These applications are to be used for example purposes only and may not be copied or referenced in another IRB application. All personal identifying information has been redacted.

How do I create an informed consent form?

We find that the consenting process can be a difficult one for students to navigate.  As such, we have created a separate FAQ dedicated to consent forms, which can be found here.

How do I determine if my study should be confidential or anonymous?

Confidential: Participants provide personal information that can be linked to the results. Only the researcher and those collecting the data have access to the identifying information, none of which can be published or shared in the results.

Anonymous: No personally-identifying information is collected, so it is impossible to know who participated, and especially impossible to link any response to any individual.

Do I have to complete human subjects research training?

Yes. All PIs and Co-PIs must complete either CITI or NIH training. Both are free to faculty and students. CITI instructions can be found here.

When can I begin collecting data for my study?

You must have IRB approval before any data collection can begin. This means you should not contact any potential participants before the IRB has approved your study.

Do not collect signed informed consent until you have IRB approval.

What are special/vulnerable populations? 

Special populations are groups that may need special protections or considerations, such as: pregnant women, human fetuses, prisoners, children, individuals with disabilities, individuals in institutions such as nursing homes, economically disadvantaged individuals, and racial or ethnic minorities.

If your project involves one of these populations, you should take extra consideration in filling out your application: How might you adapt your project to ensure you maintain the rights of an individual in one of these groups? Is there any part of your study that might be considered manipulative or abuse your position as researcher/teacher/etc.?

What do I do if I want to work with populations on reservations or individuals who are registered members of a Montana tribe?

If your project targets individuals from a Montana tribe, you should contact the IRB as soon as possible to verify what extra steps need to be taken. Some project will require you to go through a tribal IRB (or a tribal college IRB). At the minimum, your application will need to be reviewed by the Director of the Native American Center. For projects involving more than minimal risk, your application will need to be reviewed by the Rocky Mountain Tribal Leaders IRB.

Who can I talk to if I have questions about my research involving human subjects?

The Grants & Sponsored Programs staff is available to provide assistance to investigators who are engaged in research with human participants. Both Jenay Cross and Cindy Bell can be reached at 406-657-2364 or grants@msubillings.edu.