Institutional Review Board (IRB)

Reporting Concerns

Concerns or complaints regarding research with human subjects at St. Cloud State University can be brought to the course instructor, principal investigator/faculty member in charge of the research project for which human subjects are involved or any member of the Institutional Review Board, the IRB Administrator or the Institutional Official.

Serious adverse events cause serious injury to a research participant. Events must be reported to the IRB immediately, with a written report by the researcher following within 24 hours of the researcher becoming aware of the event.

All other non-serious unanticipated problems should be reported to the IRB within two weeks of the first awareness of the problem by the researcher. Prompt reporting is important, as unanticipated problems often require some modification of study procedures, protocols, and/or informed consent processes. Such modifications require the review and approval of the IRB.

Potential impact on projects

If an unanticipated problem poses a risk(s) to the participants or others, the IRB may temporarily discontinue a research project until a thorough investigation has been conducted. Dependent on the investigation, the IRB may request changes to a research study or permanently discontinue the research study.

As a result of the IRB's investigation of the unanticipated problem, revisions to the approved research study and the informed consent form may be requested.