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

Risk to subject assessment is initially evaluated by the North Texas Regional IRB. Although the project’s Principal Investigator may indicate that the project is a “minimal risk” activity, federal regulations and guidelines, as well as institutional policies, specify that a third party make this determination: in our case, the North Texas Regional IRB.

If the IRB 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, the IRB review process proceeds and the IRB chair (or designated Board member) grants final approval once it is determined the protocol meets regulatory requirements for approval.

This page was last modified on December 21, 2017