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

Risk to subject assessment is 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 Exempt Review, a determination notice is sent to the Principal Investigator.

 

Pages in Exempt Review

Exempt Category Review

What is Exempt Review

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

Which Research Studies fall under Exempt Category Review

Do studies involving Children, Prisoners, Pregnant women and Fetuses qualify

What do I submit

How will I know that a Protocol has been approved

This page was last modified on December 21, 2017