Feel free to contact the IRB staff if you are unsure how to proceed at any point. We do telephone consults and will meet with individuals or groups.

1. Consult with IRB staff if unsure whether a study meets the definition of research with human subjects.
   
   
2. Submit protocols for review and approval prior to initiating research.
   
   
3. Conduct the study as described in the approved protocol.
   
   
4. If changes are need in an approved protocol, do one of the following prior to implementing the change:
   
   

   If the protocol was approved as exempt, contact the IRB staff, or
   
   If the protocol was approved through expedited or full procedures, submit a Request to Amend an Approved Protocol.

   
   
5. If continuing review is required, submit requests in a timely fashion, usually 30 days before the expiration date.
   
   
6. Report any unanticipated risks or other problems to the IRB.
   
   
7. Report any new findings during the study that would affect the risks or benefits to your subjects.
   
   
8. Retain signed consent forms and research data in accordance with Duke's Data Retention Policy.
   
   
9. Keep your certification to conduct research with human subjects current.