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

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 staff and Executive Director.

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 Exempt Review, a determination notice is sent by the OReC Executive Director 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