Institutional Review Board (IRB)

The St. Catherine University IRB is a committee established to review and approve research involving human subjects. We strive to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.


The Institutional Review Board (IRB) reviews all research involving human subjects to ensure protection, privacy, autonomy, dignity and informed consent for research participants. The protection of human subjects is a shared responsibility among researchers, advisors, and the University and the IRB has developed a process to assist in achieving the best possible research outcome.

Faculty, staff, students, and cooperative partners engaged in research and scholarship at St. Catherine are part of a community committed to sound, ethical teaching and learning experiences that serve a larger purpose and benefit the health and well-being of society.

St. Catherine University's human subjects research program is administered by the Office of Research and Sponsored Programs (ORSP).

contact us

St. Paul Campus
Derham Hall | Room 2
2004 Randolph Avenue
Mailbox# 4068
St. Paul, MN 55105

651.690.6204
irb@stkate.edu


Apply for IRB Approval

The St. Catherine University IRB is responsible for conducting initial and continuing review of all research that involves human subjects at this institution. Investigators cannot begin research with human subjects until a complete application has been submitted to the IRB, reviewed and approved.

Mentor IRB Login

Determine whether IRB approval is needed
For research requiring IRB approval, consider the following:

  • Will you be conducting a systematic investigation to gather information about living individuals?
  • Do you intend to collect information and then present it to a public audience or at a conference?
  • Do you intend to publish findings or disseminate information based upon your work?
  • Will you be conducting interviews, surveys or focus groups?
  • Will you need access to sensitive data or records?
  • Is there any way to link the data you plan to collect with identifying information?
  • Are you seeking grant funding for research on human subjects?

If the answer to any of these questions is "yes" then you should submit your application for IRB review.

Consult the regulations
It is important to review the regulations governing human subjects protection to familiarize yourself with the policies. Show that the potential benefits of your research outweigh risks, efforts have been made to minimize risk, you are utilizing sound research methodology, and you are taking care to ensure the privacy of your subjects. Pay attention to policies on conflict of interest. In some cases, you will need to submit materials involving financial disclosure.

Complete the Human Subject Research education requirements (CITI)
The primary investigator (PI), co-PIs and faculty advisor must complete the Human Subject Research education requirements (more information below). The HSR requirement must be completed at the time the IRB application is submitted. Complete these requirements through CITI Program and upload the completion report to the Mentor IRB system.

Consult with the IRB
You may discuss with the IRB chair, or another member of the committee your proposed research project. Student research and research proposed by external investigators must be overseen by a St. Catherine University faculty or staff member.

Determine the level of review
Depending on the nature of the research and the degree of risk, projects will qualify for one of the following level of review:

  • Exempt: Research is reviewed for Exempt status (Level I review), by an IRB committee member if it involves very minimal or no risk.
  • Expedited: In general, research may be considered for Expedited review if it involves no more than minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate consent procedures.
  • Full review: In general, research requiring Full review places the subject at greater than minimal risk.

Prepare and submit your application
Application and supporting documents are to be submitted and managed through Mentor IRB for all levels of review. The classroom protocol process remains separate from the Mentor IRB system.

Await notification
Full Reviews will be scheduled based on the order in which they are received. Once the agenda is full, additional full reviews will be scheduled in the next available meeting. Notification regarding the status of a full review application will be sent about one week following the meeting. For exempt and expedited reviews, the process takes about three to four weeks from final application submission to review and respond. During periods of high volume of applications (November–January), reviews may require an additional one to two weeks.

Apply required revisions to the application
If you have been asked by the IRB to make revisions to your application in Mentor IRB, you can do this by uploading additional documents or replacing existing documents. For revised versions, highlight the areas that have been changed.

Student PIs should work with their faculty advisors on these revisions as needed, but they are not required to formally approve them in Mentor IRB.

Initiate research
Until you have received written notice that your research has been approved, you must not begin to collect data or interact with human subjects.

The Institutional Review Board (IRB) application process is conducted through an online software system called Mentor IRB available to all University faculty, staff, and students. Mentor IRB is used for submitting, managing, and communicating about IRB applications.

Submission Process

  1. CITI Training (PI documentation): Review the Human Subjects Research (HSR) Education for researchers and faculty advisers. Complete the HSR training in CITI Program and upload the completion report to Mentor IRB at the same time you submit your IRB application.
  2. Prepare IRB forms and templates: Fill out the IRB application and prepare the consent form. All forms and templates are found on the Info page of the Mentor IRB website which is the first page that opens when you log into Mentor IRB. Gather your supporting documents. If you are a student researcher, review these materials with your faculty advisor.
  3. Review Mentor IRB directions: These are directions on how to upload your CITI training, submit your application documents, upload revised documents and faculty advisor directions.
  4. IRB review process: You will be assigned IRB member(s) to review your application materials. For student PIs, faculty advisors must first approve the application in Mentor IRB. IRB approval will come as a letter from the IRB chair or IRB vice chair. Until you have received written notice that your research has been approved, you must not begin to collect data or interact with human subjects.

Mentor IRB
Log in using your Kateway username and password. The Institution ID is stkate. External researchers require a St. Catherine University faculty or staff sponsor before a Mentor IRB account will be set up. Email us with any questions.

All official St. Catherine University IRB forms and templates are located in Mentor IRB, the online IRB application management system. (Log in using your Kateway username and password; the Institution ID is stkate.) The forms are available as Microsoft Word documents.

The following documents are required for initial IRB applications:

  • IRB Application Document
  • At least one of the following: Consent form, Assent Form, or equivalent.
  • CITI completion report for researchers and research/faculty advisors. This must be uploaded to Mentor IRB at the time the application is submitted. (Human Subject Research education requirement)

When submitting your IRB application, also include all supporting documents. These documents do not have templates. These may include, but are not limited to:

  • Flyers
  • External Organization Support letter (on letterhead or through organization email)
  • Email template, Phone/Verbal script
  • Evaluation tools, surveys, quizzes, etc

If needed, the following forms are to be submitted in Mentor IRB after an application has been approved. The forms are also located in Mentor IRB with step by step directions; view directions for additional online questions in the submission process.

  • Amendments form: Use this form if there are any changes to the approved research.
  • Renewal form/Supplemental Questions form: For annual reports/continuing review, IRB research that has received expedited or full board approval must be renewed every year if the research is to continue.
  • IRB Completion form: This form is for completing/closing a research project. Once the project is complete, with no further recruitment, data collection, or analysis, researchers must fill out the IRB Completion Form.
  • Adverse Events form: In the event that a human subject is harmed as a result of participation in your project, it is necessary that you immediately inform the IRB using this form.

The Classroom Protocol has been established for streamlining the process when students are engaged in class projects that involve human participants. All student, faculty and staff engaged in human subjects research need IRB approval. If a student and his/her faculty mentor determine that a class project is research, then the project must be submitted to the IRB.

Classroom protocols conform to the following criteria:

  • All projects should be Exempt from full committee review as defined by Federal guidelines
  • Subjects will not provide and researchers will not keep any identifiers that will link the results back to the participants.
  • Projects will not involve any personal, sensitive, or incriminating topics or questions.
  • Projects will not manipulate behavior of the subjects beyond the range of usual classroom activity or college life.
  • Projects will not involve physically invasive contact with subjects.
  • Projects will only be presented to an internal audience at the University.

Instructors must submit a completed application to the IRB committee via email as early as possible during the semester. Any student project that is not consistent with the criteria defined above should be submitted to the IRB for standard review.

The classroom protocol application can be found in Mentor IRB, but please note that this process remains separate from the Mentor IRB management system. Email us or call with questions.


Human Subject Research (HSR) Policy

The Research Involving Human Subject Policy of the IRB describes the guiding principles and regulatory requirements necessary to ensure the rights, dignity, welfare, and privacy of the human subjects in all research conducted on behalf of the St. Catherine University.

Human subject research is integrated more broadly with a system and policy around research integrity, which includes the following policies found on the Office of Research and Sponsored Programs page:

  • Compliance Checklist
  • Financial Conflict of Interest
  • Responsible Conduct of Research and Scholarship
  • Debarment and Suspension

CITI Training: HSR Education

The main purpose of the IRB is to ensure that all research involving human subjects is conducted in accordance with ethical principles and federal guidelines. Education of those involved in the research process is considered essential to achieving this purpose. CITI is a provider of online, peer-reviewed research integrity education. The IRB requires investigators and faculty/research advisors to fulfill the human subjects research education requirement using CITI.

Investigators must complete only one of the Human Subjects Research courses provided within CITI. St. Kate's offers three different Human Subjects Research courses within CITI, each appropriate to their field of research: biomedical, social & behavioral, or education action research.

CITI offers additional training in Responsible Conduct of Research (RCR) and Financial Conflict of Interest, but you only need to complete these optional modules if they are required by an individual department, based on your research funding, or by the IRB after review of your application.

Investigators and advisors will need to set up a new account within CITI, or they can affiliate an existing account with St. Catherine University if they already have one.


IRB Committee

IRB Administration

Penny Moyers Deciding Official Academic Affairs 651.69.6813 Email
John Schmidt IRB Chair Doctor of Physical Therapy Program 651.690.7739 Email
David Chapman IRB Co-Chair Doctor of Physical Therapy Program 651.690.7826 Email
Amy McKenna IRB Coordinator Office of Research and Sponsored Programs 651.690.6204 Email
Mary Clem IRB Administrator Office of Research and Sponsored Programs 651.690.8820 Email


IRB Review Board

Laurel Bidwell Social Work 651.690.6704 Email
Kari Hartwig Physician Assistant Studies 651.690.6113 Email
John Fleming Occupational Science, Occupational Therapy 651.690.6951 Email
Carol Geisler Masters of Holistic Health 651.690.7789 Email
Yasemin Gunpinar Education 651.690.6313 Email
Anaya Mitra Psychology 651.690.8614 Email
Jeffrey Johnson Philosophy 651.690.6801 Email
Catherine Kelly Education 651.690.6726 Email
Nancy Koski Community Representative
Vicky Larson Nursing 651.690.6588 Email
Mary Jeanne Levitt Community Representative
Catherine Marrs Fuchsel Social Work 651.690.6146 Email
Andrea Olson Psychology 651.690.8794 Email
Nanette Hoerr Nursing - DNP 651.690.6057 Email
Sharon Radd Master of Arts in Organizational Leadership 651.690.6189 Email
Joyce Yukawa Master of Library and Information Science 651.690.8661 Email

Committee Meetings

The IRB Committee meets to review requests for Full (Level III) applications. All IRB applications and supporting documents must be submitted through Mentor IRB.

Meeting review slots are limited. Full Reviews are scheduled based on the order in which they are received. Once the meeting agenda is full, additional full reviews will be scheduled in the next available meeting. For exempt and expedited application reviews, the process takes about three to four weeks from final application submission (including faculty advisor approval) to a response from the IRB, unless additional questions and/or documents are required. During periods of high volume of applications, reviews may require an additional one to two weeks.

Until you have received written notice that your research has been approved, you must not begin to collect data or interact with human subjects.

Meeting Schedule
IRB Meeting Date Date Electronic FULL Review Application is Due
Thursday, Sept 1
Workshop Week
Thursday, Aug 18
Wednesday, Sept 14
1:30-3:00 pm - CdC 362
Wednesday, Aug 31
Friday, Sept 30
1:00-2:30 pm - CdC 362
Friday, Sept 16
Wednesday, Oct 12
1:30-3:00 pm - CdC 362
Wednesday, Sept 28
Friday, Nov 4
1:00-2:30 pm - CdC 362
Friday, Oct 21
Friday, Nov 18
1:00-2:30 pm - CdC 362
Friday, Nov 4
Wednesday, Dec 7
1:30-3:00 pm - CdC 362
Wednesday, Nov 23
Friday, Dec 16
1:00-2:30 pm - CdC 362
Friday, Dec 2
Wednesday, Jan 18
1:30-3:00 pm - CdC 362
Wednesday, Jan 4
Friday, Feb 10
1:00-2:30 pm - CdC 362
Friday, Jan 27
Wednesday, Feb 22
1:30-3:00 pm - CdC 362
Wednesday, Feb 8
Friday, March 10
1:00-2:30 pm - CdC 362
Friday, Feb 24
Wednesday, March 29
1:30-3:00 pm - CdC 362
Wednesday, March 15
Friday, April 7
1:00-2:30 pm - CdC 362
Friday, March 24
Wednesday, April 19
1:30-3:00 pm - CdC 362
Wednesday, April 5
Friday, May 5
1:00-2:30 pm - CdC 362
Friday, April 21
Wednesday, May 17
1:30-3:00 pm - CdC 362
Wednesday, May 3