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 Sponsored Programs, Research and External Engagement (SPREE).


Mentor IRB Online IRB Application Tracking System

Mentor IRB is the tool St. Kate's has chosen to use as our online application management system. New IRB applications are submitted via the Mentor IRB system for IRB review as well as approved applications are monitored via Mentor IRB (amendments, completions, etc). Mentor IRB is accessible using your St. Kate's 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 IRB with any questions.

Login to Mentor IRB

Mentor IRB directions


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.


Application Process

  • 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.

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.

The primary investigator (PI), co-PIs, research assistants and faculty advisor must complete the Human Subject Research education requirement. Researchers need to choose only one track under Human Subject Research course: Biomedical Investigators, Social Behavioral Investigators or Education Action Research. Your CITI completion report will automatically be uploaded into Mentor IRB if you use your St. Kate's email address within CITI or set your CITI username equal to your St. Kate's username. The HSR requirement must be completed at the time the IRB application is submitted.

CITI login

Directions for CITI

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.

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.

Application and supporting documents are to be submitted and managed through Mentor IRB for all levels of review. Fill out the IRB application and prepare the consent form. All forms, directions 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. Note:The classroom protocol process remains separate from the Mentor IRB system.

Submitted IRB applications must be approved by your Faculty Advisor before the IRB will start your IRB Review.

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. 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. 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.

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.

Mentor IRB directions — revisions required

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.

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

Forms and Supporting Documents

All official St. Catherine University IRB forms and templates are located in Mentor IRB, the online IRB application management system. (Log in using your primary 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.

Classroom Research

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 classroom protocol 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.

Classroom protocol application