Step 6. Does Your Human Subjects Research Have to be Reviewed by the Convened IRB?
What is convened IRB review?
- All non-exempt human subjects research must obtain IRB review and approval.
- Non-exempt research that doesn’t qualify for expedited review must be reviewed by the convened IRB. Studies that require convened review include: clinical trials studying an investigational drug, device, or surgical procedure; studies involving blood draws over a certain amount; studies involving procedures that are particularly invasive or are greater than minimal risk.
- The convened IRB is a group of IRB members that review and approve research. Each of UW’s four IRBs meets every other week. When your application is reviewed, the IRB will generally approve, conditionally approve, or defer the application. Review the worksheet, IRB Review Outcomes for more information.
- Review by the convened IRB generally takes longer than expedited review, particularly when the convened board needs additional information before approving the application. The time from submission to approval depends on things like the inclusion of vulnerable populations, the complexity of the study, or when the UW is reviewing on behalf of other institutions. HSD’s median turnaround times for convened review are listed on our website.
Request convened IRB review
The steps for submitting an application for IRB review are the same whether it will be reviewed by a designated reviewer or the convened IRB.
- Complete the standard IRB Protocol form or on the No Contact version of the form.
- In Zipline, create a new application by clicking on the Create a New Study button and following the instructions. Attach your completed IRB Protocol form at the indicated place.
- HSD will assess your application to determine if it requires review by the convened IRB.
- Instructions for submitting the study and responding to the IRB’s requests for clarification or changes can be found in the Zipline Researcher Guide.