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.
IRB-1400 Promptly Reportable Information
This policy establishes the requirements for the prompt identification, reporting and review of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information.
IRB-1400 Promptly Reportable Information
This policy establishes the requirements for the prompt identification, reporting and review of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information.
IRB-1400 Promptly Reportable Information
This policy establishes the requirements for the prompt identification, reporting and review of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information.
IRB-1400 Promptly Reportable Information
This policy establishes the requirements for the prompt identification, reporting and review of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information.
IRB-1400 Promptly Reportable Information
This policy establishes the requirements for the prompt identification, reporting and review of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information.
IRB-1450 IRB Review and Reporting of Promptly Reportable Information
This policy establishes the requirements and responsibilities for the DUHS IRB’s review and reporting obligations of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information.
IRB-1450 IRB Review and Reporting of Promptly Reportable Information
This policy establishes the requirements and responsibilities for the DUHS IRB’s review and reporting obligations of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information.