Institutional Review Board

Updated Policy on Research during Covid-19

Please read our Covid-19 research policy, updated January 11, 2021.

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.

Standard Operating Procedures – Jan.12.2021

Contact Us

Submit documents, ask questions, and get updates: irb@smumn.edu

The inbox is monitored Monday through Friday by the IRB Administrative Assistant, Emma Erdahl.

You may also contact Dr. Jack McClure, the IRB Chair, at jmcclure@smumn.edu or Dr. Eden Wales Freedman, the IRB Administrator and Vice Provost for Faculties and Academic Affairs at ewalesfr@smumn.edu

What is the review process?

Applications for IRB review are submitted to the IRB Administrative Assistant via email to irb@smumn.edu.
The IRB Administrative Assistant examines the application for clarity and completeness. If anything is missing, the application is returned to the PI for completion and resubmission.
When the application is ready for review, the application is a protocol identification number and the Administrative Assistant determines the necessary level of review.
The IRB member reviewing the protocol may take several weeks depending on the number of other submissions at the time. They may request modifications to the study to be resubmitted before approval.
The IRB Administrative Assistant will notify the PI and their Research Advisor (if applicable) via email as to whether the protocol is approved or further modifications are requested.

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 modification may take longer to process. Several factors, including the review level, need for modification, 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.

What will I need to submit?

See the Application on the Submission page for detailed instructions.

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