New IRB Form for Enrollment Exception Requests

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The IRB has created a new “Protocol Enrollment Exception Request” submission form and it is now available in iRIS.

When do I use the Protocol Enrollment Exception Request form?

Use this form when you are requesting to enroll a single individual who does not meet the entry criteria for your study. Such requests should be (1) rare, (2) done for the purpose of serving the best interests of the potential study participant, and (3) approved by the IRB prior to enrolling the individual.

See the IRB website guidance for more information on enrollment exceptions.

Why did the IRB create this form?

In order to determine whether an enrollment exception request is approvable, the IRB reviewer needs specific information that is not currently included in the general Modification form. As such, we have created a stand-alone form that solicits these specific details. We hope that this will lead to fewer stipulations for enrollment exception requests.

How do I use the Protocol Enrollment Exception Request form?

Start by reading the step-by-step guidance (click link for pdf) on how to fill out this form on the iRIS help site. Then, go to your iRIS Study Dashboard to access and complete the form. As you fill out the form, read the guidance within the form to make sure you’re answering the questions as accurately as possible.

Please send questions or comments about this form via email to IRB@ucsf.edu. Thank you!