After a researcher has secured approval of a protocol, he or she has additional responsibilities.

1. Secure prior written approval before altering the research protocol in any way. (This includes research approved as exempt.)
   
2. Prepare continuing review applications for review and approval prior to the expiration date provided on notices of approval.
   
3. Report any unanticipated risks or problems to the IRB.
   
4. Retain research data for a minimum of five years after final reporting or publication of a project, as required by Duke's Data Retention Policy. Note that signed consent forms are covered by the policy. (The federal regulations for protecting human subjects require that data and forms be retained for three years. Duke policy overrides the federal policy.)