Frequently Asked Questions
What is the IRB?
IRB stands for Institutional Review Board. The purpose of the IRB is to protect human research subjects from being harmed as they participate in research. Researchers do not intentionally engage in harmful practices, but the IRB provides an additional perspective to help identify risks or possible problems which may have been overlooked by the researcher.
The IRB at the University of St. Thomas has nine members from a variety of disciplines who meet together at least monthly during the academic year to review applications from researchers and to discuss issues related to research with human subjects. To learn more about the UST IRB, please visit our website.
What research must be submitted to the IRB?
Any research on human subjects conducted by students, faculty, or staff at the University of St. Thomas or any research by outside researchers using UST subjects must be submitted to the IRB for review before the research begins.
What is considered 'human subjects' research?
According to the federal regulations, any inquiry involving systematic data gathering with an intent to create generalizable knowledge or to add to the knowledge base of a field is considered human subjects research.
Why does the University of St. Thomas require that all human subjects research be approved by the IRB?
The federal regulations have set the standards for research. The University of Saint Thomas IRB determined that these federal standards be used for research involving all human subjects for these three reasons:
1) Research subjects for UST research deserve the same protections from research risk, no matter who sponsors the research.
2) Using these guidelines provides the best protection for researchers who can be assured that the research they are doing has been reviewed by the IRB who will help reduce risk to the subjects.
3) When the University requests federal funds for projects involving human subjects, part of the review process on those grants is the determination that UST has in place set principles and guidelines that govern the institution, its faculty, and staff. This is done to protect the rights and welfare of all human research subjects affiliated with the University, regardless of the funding source.
Must every student in my research course submit an application to the IRB?
No, when students conduct human subject research as a part of a classroom assignment, the instructor may wish to apply for approval for all the students so that each student need not apply individually for IRB approval. Classroom protocols must meet the requirements for exempt or expedited review only. If students are proposing research which needs full review, they must apply individually to the IRB for approval of their projects.
What must I include with my IRB application?
Include the IRB application form (in the document library at www.irbnet.org) signed by the appropriate parties, any and all consent forms, permission by the agency in which the research will be conducted (either on the agency form or on letterhead), and any surveys, questionnaires, or other research protocol which are part of the research. ALL materials are required to be submitted electronically to www.irbnet.org; no hard copies will be accepted.
Where can I get IRB forms?
The IRB application form and all other forms for all levels of review along with supporting documentation forms are in the document library at IRBnet.
What happens in an IRB Review?
The three levels of review are handled somewhat differently.
A proposal submitted under the exempt guidelines is reviewed by the IRB administrator to determine whether the research qualifies as exempt research.
Two members of the IRB review anexpedited proposal to check for proper safeguards of subjects and to ensure that risks to subjects are minimal. Sometimes the reviewers will call or email the primary investigator with questions about the proposal. The reviewers discuss the proposal and make recommendations which are then forwarded to the primary investigator. A proposal which has serious concerns is referred to the full IRB for review.
Afull review proposal is reviewed by the entire IRB at a regularly scheduled meeting. The IRB discusses the proposal. If the primary investigator wishes, he or she may come to the meeting to answer questions. A vote is taken by the board. A simple majority of the board is needed to approve the proposal.
The IRB may approve, conditionally approve, defer, or disapprove a proposal. Conditional approval means that the proposal is acceptable in principle, but there are changes (often in the consent form or in what is explained to subjects) that need to be made before the research proceeds. If you receive conditional approval, your proposal will be returned to you via www.irbnet.org and you will be asked to make changes and resubmit. A deferral means that there is not enough information available for the board to make a determination; your proposal will be returned to you. A proposal that is deferred or disapproved may be resubmitted following revisions if the primary investigator wishes.
How long does an IRB review take?
An exempt review takes approximately one week.
How long is IRB approval good for?
All ongoing research must be reviewed at least once a year by at the same level of review. The IRB sets the frequency of review and may determine that some research should be reviewed more frequently. The IRB will notify primary investigators when to submit their research for review.
I have been conducting research on my topic for years, long before there was an IRB at St. Thomas. Do I need IRB approval?
Yes. All ongoing research must be reviewed at least annually. Once you have IRB approval for ongoing research you will need to complete and submit the continuing review form on IRBnet. If the IRB has not yet reviewed your ongoing research, you need to submit an application to the IRB.
Does an outcome assessment fall under IRB review?
No, outcome assessments and other such inquiry which aims to improve an organization or services to consumers is not considered research for purposes of IRB review. Nevertheless, it is important to carry out such activities under the ethical guidelines established by professional codes of ethics, coercion, maintaining confidentiality, voluntary participation, etc.