Who decides whether or not a project has “minimal risk”?

Expedited Category Review | What is Expedited Review | What are the Criteria | What is the definition of minimal riskWho decides whether or not a project has “minimal risk” | What Research Categories fall under Expedited Category Review | What is the application process | How will I know that a Protocol has been approved | Who receives these IRB Action Notices | What happens if my Expedited Review does not qualify

At UNTHSC, risk to subject assessment is initially evaluated by OReC Executive Director and staff. Although the project’s Principal Investigator may indicate that the project is a “minimal risk” activity, federal regulations and guidelines, as well as UNTHSC policy, specify that a third party make this determination: in our case, the OReC Executive Director and staff.

If the OReC Executive Director concurs that a project is “minimal risk“, it is then assessed for a specific category of research, again, based on federal regulations. If this category meets the regulations for Expedited Review it is then sent to the IRB chair for consideration.