Current policies related to the Duke Health IRB and Human Research Protection Program (HRPP) are located here. View the complete list of policies.The policies are below, and you can search for policies in the following categories:
Expiration of IRB Approval and Closing Reports
This policy defines an active research study and outlines the notification procedures for IRB expiration. The policy also discusses lapses in IRB approval.
Holds, Suspensions, and Terminations
This policy provides the procedures around the IRB's placing a study on hold, suspending a study, or terminating a study.
The policy defines non-compliance (serious or continuing) and gives examples. The policy describes how the IRB handles allegations of non-compliance, the process for review, and actions available to the convened IRB.
Reporting to DUHS Officials and Federal Agencies
The policy describes procedures for the IRB to follow when reporting to DUHS officials and appropriate federal regulatory agencies the results of its deliberations related to unanticipated problems involving risks to subjects or others, suspension or termination of IRB approval, and serious or continuing noncompliance.