Protocols that involve “research” with “human subjects” need to be submitted through the IRB review process for approval. If you are not sure if you are conducting research with human subjects, then you should first visit our Determining if IRB Review is Needed web page for additional information.
IRB submissions are reviewed under one of the following three levels of review:
- Means the study is exempted from the requirements of the federal regulations.
- Exemption determinations must be made by qualified IRB staff; you cannot make this determination based on your own evaluation.
- The TOPAZ “IRB Exemption Form” is used for submitting Exempt requests.
- Learn more about Exempt Review.
- Means the study is clearly classified as at least one of nine expedited categories.
- An expedited study will be reviewed by a single qualified IRB member and will be processed on a rolling basis.
- The TOPAZ “IRB Approval Form” is used for submitting Expedited requests.
- Learn more about Expedited Review.
Full Board Review
- Means the study involves more than minimal risk and is not eligible for an Exempt or Expedited review.
- There are specific deadlines by which a submission must be received.
- The TOPAZ “IRB Approval Form” is used for submitting Full Board requests.
- Learn more about Full Review.