IRB FAQs

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IRB FAQs

Review the St. Catherine University IRB website for more information on IRB, and about the different levels of review, the Human Subject Research (HSR) requirement in CITI Program, and additional HSR resources. Contact Debbie Yang, IRB Assistant with questions at irb@stkate.edu or 651-690-6204.

How do I submit an IRB application?

Directions for submitting an application called Mentor IRB Directions (PDF) can be found on the Mentor IRB page of the St. Catherine University IRB website and in Mentor IRB . The directions contain information on uploading PI Documentation/CITI trainings, the application process, faculty advisor directions, Mentor IRB messaging and making revisions.  More detailed directions for faculty advisors and PI Documentation/CITI are in  Mentor IRB along with the application word document, consent/assent/HIPAA templates, and additional procedures. IRB applications must be submitted in Mentor IRB and will not be accepted through email.

What documents need to be submitted for the Mentor IRB application?

The IRB application is available in Mentor IRB as a word document. Completely fill out the application.  The consent, assent, and HIPAA form templates are also available in Mentor IRB. Supporting materials may include flyer, recruiting script for e-mail/phone, consent form, survey or data collection methods or measures, support letters, etc. Information must be consistent in the application, consent form and supporting materials.

How do I log into Mentor IRB?

Log into Mentor IRB using your St. Catherine University username and password. The Institutional ID is stkate. The link to Mentor IRB is on the Mentor IRB page.

Will I get a confirmation email that my application has been submitted?

You will not receive a confirmation email. To check that your application is in Mentor IRB, go to My Protocols/Applications and select your project title. On the next page, check that your application, consent form, and supporting documents have all been successfully uploaded.

What is the role of the faculty advisor for the IRB process?

A faculty advisor works with their student PI (Primary Investigator) on their research project including the IRB application and supporting documents. Advisors must approve the student IRB application in Mentor IRB in order to begin the review process. They are responsible for reviewing all uploaded application. Faculty advisors may see their student PI applications in the Mentor IRB system by going to Student Protocols and selecting the project title. Faculty advisors are required to complete the Human Subjects Research education requirements.

What is the estimated turn-around time for an IRB review of an application?

The estimated turn-around time IRB application once the review process begins is three to four weeks. Student PIs require faculty advisor approval before the review process can begin. The time will be longer if there are questions for the PI during the review process, requests for missing documents, and/or revisions required. It is important to check your St. Catherine University email for questions and messages from IRB. November - January is a busy period for IRB applications. If submitting an application during this time, note that turn-around times will be up to two additional weeks. This does not include the days the University is closed (such as the holiday break) when IRB members do not review applications. The same is for additional holidays and breaks during the year.

Who is required to complete the Human Subjects Research (HSR) education requirements?

The primary investigator (PI), co-PIs and faculty advisor must complete the HSR education requirements. Beginning fall 2014, the HSR requirement must be completed at the time the IRB application is submitted. Complete these requirements through CITI Program (find the link on the ORSP CITI Program page) and upload the completion report to the Mentor IRB system. CITI Program also houses multiple training options. IRB applicants only need to complete the Human Subject Research course (either the biomedical investigators or social behavioral investigators track). If you have questions about signing up for CITI Program, contact Cathy Seurer in the Office of Research and Sponsored Program at 651-690-8822.

I have already completed the CITI training at another institution. Will this complete my HSR education requirements for St. Catherine University?

Each institution may have its own requirements. You will need to affiliate your account with St. Catherine University and if you have completed the same modules, they will be transferred over.  If you have questions about signing up for CITI Program, contact Cathy Seurer in the Office of Research and Sponsored Program at 651-690-8822.

I don’t check my St. Catherine University email. Can I change the email that the Mentor IRB system sends messages to?

All notifications and official messages from the IRB are sent through the Mentor IRB messaging system and copied to your St. Catherine University email account. Your e-mail cannot be changed to another e-mail account.

As a program director or course instructor, how do I get access to my student’s IRB application?

A student PI may only select one faculty advisor who will have access to their IRB application. If a program director or instructor also would like to have access, the student must enter them in as a co-PI when they submit their application.

When can I begin my research project?

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