The St. Catherine University IRB is responsible for conducting initial review and monitoring 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. Remember 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.


Mentor IRB - Online IRB Application Tracking System

Mentor IRB is the St. Kate's 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.

Login to Mentor IRB

Mentor IRB directions


Application Process

The St. Kate's IRB is here to help ensure human subject research is conducted ethically. Feel free to contact the IRB,with questions prior to submitting your IRB application at irb@stkate.edu, or contact either an IRB chair or member directly.

Consider the following to determine if IRB approval is required when conducting human subject research:

  • 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.

Human subject research is overseen by the Office for Human Research Protections(ORHP) within the U.S. Department of Health & Human Services(HHS). 45 CFR 46 contains the federal regulations for the protection of human subjects in research and is typically referred to as the Common Rule (45 CFR 46 Subpart A). Federal regulations require you to obtain informed consent, show that the potential benefits of your research outweigh risks, minimize risk to participants, utilize sound research methodology, and ensure the privacy of your subjects. Additional federal regulations may apply to your research outside of the purview of the IRB, such as financial conflict of interest and responsible conduct of research.

The primary investigator (PI), co-PIs, research assistants and faculty advisor must complete the Human Subject Research education requirement. Researchers need to complete one course about Human Subject Research: 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

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.

All official St. Catherine University IRB forms and templates are located in Mentor IRB. The forms are available as Microsoft Word documents. The following documents are required to submit a new IRB applications:

  • IRB Application Document
  • At least one of the following: Consent form, Assent Form, or equivalent.

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

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

IRB approval will come as a email from the IRB chair or IRB co-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 application submission to review and initial IRB response. 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.

The investigator must not begin to collect data or interact with human subjects until they have received written notice that their research project has been approved by the IRB. The investigator is responsible to communicate with the IRB during their research project, including submitting Amendments, Renewals, Adverse Events notification, and Completion notification. Directions for each of the processes are located within Mentor IRB.

Survey Tools

St. Kate's provide two survey tools for use by faculty, staff and student investigators: Qualtrics and REDCap. Additional information for about each survey tool can be found in Service Now.

Qualtrics General Information

REDCap General Information


    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.

    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 irb@stkate.edu as early as possible during the semester. Any student project that is not consistent with the criteria defined above should complete an individual IRB application and submit it to the IRB for standard review via Mentor IRB.

    Classroom protocol application