Part 4: Continuing review
New information that would significantly change the assessment of the potential risk to subjects must also be brought to the IRB's attention in a timely way.
Adverse events that are serious, unexpected, and possibly related to the study--as well as any deaths, regardless of whether they are related to the study—are of major concern. The IRB can provide information on the specific requirements for reporting adverse events.
For all non-exempt research, investigators submit a progress report (continuing review form) to the IRB on an annual basis. If the project continues for more than five years, investigators must submit a complete application after every fifth year, just as if the project were new. This procedure insures that long-term projects are thoroughly reviewed on a periodic basis.
Certification
As part of the effort to guarantee that all research on campus provides protection to human subjects, UW-Stout keeps records of all personnel, including students, who have completed human subjects training. The following certification pages are the mechanism for keeping these records.
In addition, you must certify that you have completed this tutorial before submitting a protocol to a UW-Stout IRB for review. You may also need to demonstrate to a funding agency, an instructor, or others that you have completed this training.
This certification must be completed online and a copy of this certificate must accompany each IRB protocol filed for approval.