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 don’t 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.
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 requirement 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.
I have been conducting research on my topic for years, way
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 be sent a reminder and some forms to submit to the IRB for continuing review. If the IRB has not yet reviewed your ongoing research, you need to submit an application for it to the IRB.
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 constitutes research is considered human subjects research.
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.
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 one member of the IRB to determine whether the research qualifies as exempt research.
Three member of the IRB review an expedited proposal to check it for safeguards to 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 would be referred to the full IRB for review.
A full review 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. A deferral means that there is not enough information available for the board to make a determination. 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.
An expedited review takes approximately three weeks.
A full review takes place during regularly scheduled meetings. Proposals must be submitted two weeks (14 calendar days) before a scheduled IRB meeting. Primary investigators will be informed of the board’s decision within one week of the meeting.
What must I include with my IRB application?
Include the application form, signed by the appropriate parties, a consent form, permission by the agency in which the research will be conducted (on letterhead), and any surveys, questionnaires, or other research protocol which are part of the research.
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 notifies primary investigators when to submit their research for review.
I’ve heard that only federally funded research needs to be
approved by an IRB. 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 IRB at St. Thomas determined that these federal standards would be used here for all human subjects research for 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 a set of principles and guidelines that govern the institution, its faculty, and staff, to protect the rights and welfare of all human research subjects affiliated with the university, regardless of the funding source.
Where can I get IRB forms?
Forms for all levels of reviews and a template that you can use to create your consent form are on the IRB website.
Institutional Review Board
University of St. Thomas
2115 Summit Ave., St. Paul, MN 55105
651-962-5341
irb@stthomas.edu