Frequently Asked Questions
Answers to the IRB's most frequently asked questions are listed below. If you read through the answer and need additional information or have questions that are not included on this page please contact the IRB office at (651) 962-6035.
The average length of time between submitting an IRB application and project approval is two weeks. However, each project is different and may require varying lengths of time for review.The IRB office will respond to IRB applications within 0-8 business days of the date of submission for all exempt and expedited projects and up to 13 days post submission for projects requiring full review. The IRB most often responds with a request for revisions that the researcher(s) must address prior to approval. Researchers are strongly encouraged to submit their Application for Initial Review and all completed supplemental forms at least one month prior to the proposed start of research taking place in the United States and at least two months in advance for all international human subjects research and research that requires a consultant.
IRB approval expires within one year of the approval date. The IRB has the authority to require continuing review for intervals less than one year, which often depend on the nature and severity of risk to participants involved in the study. Researchers will be informed of the project expiration date when they receive their IRB approval letter. To continue human subjects research beyond the expiration date, an Application for Continuing Review (and any supporting forms, such as an updated consent form) must be submitted at least two weeks prior to the expiration date. If expiration occurs without continuing review, the project will be closed and all contact with human subjects and their private, identifiable information must cease immediately.
Researchers must submit an Application for Continuing Review to continue research with human participants or analysis of their private, identifiable information past an expiration date. The IRB requests that all Applications for Continuing Review be submitted at least two weeks prior to the project expiration date for exempt and expedited review and one month prior to the expiration date for projects that were reviewed by the full board. If you answer YES to all of the following statements, your project may not need continuing review and you should contact the IRB office:
- The research project is closed to all recruitment;
- All participants have completed all research-related interactions or interventions with the researcher(s);
- The researcher(s) is not planning any follow-up with any participants;
- Collection of any private, identifiable information is complete;
- All data has been completely de-identified; and
- Analysis of any private, identifiable information is complete.
Please note that it is the investigator's responsibility to watch their project in IRBNet, pay attention to any expiration notices, and know when it will expire.
I want to submit an Application for Continuing Review or Application to Amend Previously Approved Research. How do I submit these in a new package in IRBNet?
To add new applications or materials to an existing project in IRBNet, investigators must submit materials using a new package in IRBNet. A package is a digital file folder within a project in IRBNet. To submit documents in a new package, click on the project you wish to submit documents for. Next, click "Designer" and then "Add New Document." Follow the prompts to add a document to a new package. IRBNet will produce a new tracking number for each package you create within a project. For example, if your original project package tracking number is 111222-1, the next package you open will be labeled 111222-2. Each package must be electronically signed by the principal investigator, co-investigator(s), and research advisor(s). Once all signatures have been obtained, click "Submit this Package" to submit your materials to the IRB. Please do not open a new project for continuing review or amendments. New projects should be opened for new research studies.
I missed the application submission deadline. Can I submit my application or do I need to wait until the next deadline?
Applications for exempt and expedited research studies are reviewed on an ongoing basis by IRB members and can be submitted at any time. The IRB meets every other week to review all other protocols. If you know that your study requires review by the fully convened IRB, please make plans to submit your completed application and all supporting documents by one of the submission deadlines. Any submission after 5:00pm on the deadline date will be considered for another IRB meeting. During the summer months (mid-May through late August), there are no submission deadlines since IRB meetings are scheduled on an as-needed basis.
To determine the level of review for your study, read through the information provided on our Levels of Review website pages. The following FAQs may also help you determine your level of review. Researchers are encouraged to contact the IRB office to describe their study and estimate the level of review for their application. Ultimately, only the IRB office can identify the level of review once review of the risk to participants involved in the study has been completed.
No, "exempt" and "not human subjects" are not the same thing. A "not human subjects" designation means that the research study does not involve any human participants or their private, identifiable information as defined by federal regulations. "Exempt" is a review level for research studies that involve human participants or their private, identifiable information, have no more than minimal risk, and fit into one of six categories identified by the Department of Health and Human Services. Researchers must apply for IRB approval to conduct research that falls into an extempt category of review.
My research falls into one of the categories for exempt review. Do I still need to apply for IRB approval?
Yes. "Exempt" does not mean that the study is excluded from IRB review; rather, "exempt" is a level of review for research that involves human participants or their private, identifiable information, no more than minimal risk, and fits into one of six categories defined by federal regulations. Researchers who estimate that their project fits into one of the exempt categories must receive IRB approval prior to any contact with human participants. The IRB office will determine the appropriate review level once an application has been submitted.
No. "Expedited" review does not mean that the application will be reviewed faster; rather, "expedited review" is a level of review where a research study presents no greater than minimal risk to participants, there is a possibility that identifiers will be collected, and the research fits into one of eight categories defined by federal regulations. Projects that are reviewed at the expedited level can be reviewed by the IRB chair or one or more members of the IRB rather than the fully convened board.
The Collaborative Institutional Training Initiative (CITI) Program courses expire four years from completion if the course was taken through the University of St. Thomas. CITI completion reports state the date completed and date of expiration on the report, regardless of where the course was taken. Once researchers have completed the full CITI training course, they may renew the training every four years by completing the shorter refresher course. If the IRB has determined that they will honor a human subjects research training other than the CITI Program for any investigator, that training will expire on the expiration date listed for that course or four years from the completion date, whichever is sooner.
Yes, the IRB office is open throughout the summer months. Please feel welcome to call, email, or visit the IRB office with questions during the summer. In the summer, IRB meetings are scheduled on an as-needed basis since there are fewer projects requiring full review during these months. Please call the IRB office if you know that your project will need to be reviewed by the fully convened board in the summer.