Institutional Review Board

How to Submit to the IRB

The Institutional Review Board has developed a new IRB application process with cloud-based software Cayuse Human Ethics. With Cayuse, we will be able to streamline the IRB application form for researchers and more efficiently handle the volume of submissions we receive.

Some benefits of Cayuse IRB include:

  • Easy to use electronic forms with logic-branching features
  • Real-time submission tracking
  • IRB record management from initial submission through study closure

Cayuse IRB is now live. This means that students and faculty are able to log-in and submit applications through Cayuse. Please use this form to request an account: Request a Cayuse Account

Read a sample application: Example Application – Interview procedures

 

What is the IRB?

The Saint Mary’s University of Minnesota Institutional Review Board (IRB) oversees all human subjects research involving SMUMN students, staff, or faculty members. The IRB provides protection for the human subjects who may participate in research.

No research with human subjects that is generalizable or will be publicly disseminated may occur without prior approval from the IRB. Approval is provided through an official letter that is sent to the Principal Investigator (PI) after the IRB has reviewed the protocol and assessed the study.

IRB SOP – Updated December 2023

Contact Us

Ask questions and get updates: irb@smumn.edu

The inbox is monitored Monday through Friday by the IRB Coordinator, Mackenzie Stokes Xalix.

You may also contact Dr. Claudia Preston, the IRB Chair, at cpreston@smumn.edu.

How long does the process take?

The turnaround time for complete protocols from assignment to review on average will take two to three weeks for exempt and expedited. Protocols requiring changes may take longer to process. Several factors, including the review level, need for changes, number of protocols, and workload of each IRB member will affect the turnaround time. Researchers should submit applications with this in mind and apply early enough to account for extemporaneous circumstances.

What types of projects need IRB approval?

Protection of human subjects is a shared responsibility of the PI/Researcher, advisor, the IRB, and the University. Any research activity involving human subjects that will be publicly disseminated and undertaken by any faculty, staff, employee or student at Saint Mary’s University of Minnesota must be reviewed and approved by the IRB prior to commencing the research activity.

Saint Mary’s University of Minnesota uses the federal definition of research as defined in the Federal Common Rule (45 CFR 46.102): “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

The following activities are deemed not to be research:

I. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary
criticism, legal research, and historical scholarship), including the collection and use of
information, that focus directly on the specific individuals about whom the information is
collected.

II. Public health surveillance activities, including the collection and testing of information
or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public
health authority. Such activities are limited to those necessary to allow a public health authority
to identify, monitor, assess, or investigate potential public health signals, onsets of disease
outbreaks, or conditions of public health importance (including trends, signals, risk factors,
patterns in diseases, or increases in injuries from using consumer products).

III. Collection and analysis of information, biospecimens, or records by or for a criminal
justice agency for activities authorized by law or court order solely for criminal justice or
criminal investigative purposes.

IV. Authorized operational activities (as determined by each agency) in support of
intelligence, homeland security, defense, or other national security missions.

CITI Training

All principal investigators/researchers, student researchers, and student research advisors/supervisors conducting research involving human subjects at Saint Mary’s must enroll and complete the Collaborative Institutional Training Initiative (CITI) program. This training must be completed prior to submitting a research protocol to the IRB. All students, faculty, and staff with a Saint Mary’s email can sign up and register at no cost.

Log in to CITI