IRB Application Process
Steps in the Application Process:
- Determine whether IRB Approval is needed
- Consult the regulations
- Complete the Human Subject Research Education requirements (CITI)
- Consult with the IRB committee (optional)
- Determine the level of review
- Prepare and submit your application
- Await notification
- Apply Required Revisions to the application
- Initiate Research
- Frequently Asked Questions
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.
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.
The primary investigator (PI), co-PIs and faculty advisor must complete the Human Subject Research education requirements. 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.
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.
Depending on the nature of the research and the degree of risk, projects will qualify for one of the following level of review:
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, reviews may require an additional one to two weeks.
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. View the step by step directions on how to do this.
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.