Exempt Studies

It is understood this project will be conducted in full accordance with all applicable HRPP Policies. It is also understood that the ORAOffice of Regulatory Affairs (ORA) will be immediately notified of any proposed changes for youra research project that:

1. Affect the risk-benefit relationship of the research
2. Pose new risks which are greater than minimal
3. Constitute a new risk to privacy or confidentiality
4. Involve sensitive topics (including but not limited to personal aspects of the subjectssubject’s behavior, life experiences or attitudes)
5. Involve deception
6. Target a vulnerable population
7. Include prisoners or children
8. Otherwise suggest loss of the exempt status of the research.

No changes to exempt studies are required to be submitted for review, which is outlined in yourthe approvalletter letter.of approval. If you feel a change is warranted, please contact our officeORA utilizing the RSS message portal of the application in question.

You are encouraged to contact the ORA to discuss whether changes to exempt research requires review by the IRBquestion or please viewreview HRPP policy 2.6 (Exempt Research) or HRPP policy 2.4 (IRB Review of Changes in Previously Approved Research).