Q: When is IRB review required?
A: IRB review is required for regulated, non-exempt, human subjects research.
Every word in this answer has been the subject of IRB conference workshops.
SBER studies have many threshold decisions unlike clinical research that almost always require review by the full convened IRB. Selecting too low a level can result in extra corrective work but selecting too high a level can yield questions more appropriate for other studies. Researchers in the SBER realm must be conversant with the decision tree.
There are many versions of the decision trees. Here are three:
You should be able to answer these questions after reviewing this section:
CAUTION and NOTICE
DECISION TREE 1: This first decision tree sets the stage. It is the easiest but lacks any explanation.
DECISION TREE 2: This decision tree is referencing our forms. (By institutional we mean your company or organization.)