What is institutional approval?

The term “institutional approval” can have different meanings depending on your research environment. For example, human subjects research projects that are reviewed by the Campus IRB or DUHS IRB will receive a notice that indicates that the research protocol has been reviewed and approved by one or more parties. However, additional reviews may be required (such as agreements and contracts) and take place outside of this process.

For studies reviewed by Duke Health IRB, institutional approval is not achieved until the study team receives an automated email from Oncore that issues the approval notice.

For research teams operating outside of the DUHS IRB approval process, “institutional approval” denotes a collection of all of the independent approvals needed before work can begin. In this case, the PI is responsible for ensuring that all necessary approvals are in place before research activity begins.

Research teams are encouraged to understand the following, to make the institutional approval process as smooth as possible.

• Be aware of which approvals apply to your research by using the Institutional Approval query tool or by contacting myRESEARCHnavigators@duke.edu.
• Work with the Navigators or your research unit's support groups to understand what reviews can happen concurrently versus what must be sequential.
• Recognize what training requirements individuals must have prior to beginning work on a research project.