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 Category Review of Research Studies?
- You are here: Who decides whether or not a project has "minimal risk"?
- According to the federal regulations, which research studies fall under Exempt Category Review?
- Do research studies involving Children, Prisoners, Pregnant women and Fetuses qualify for Exempt Category Research?
- What do I submit to the IRB for an Exempt Category Research?
- How (and When) Will I know that a Protocol has been Approved?