Submitting a Social and Behavioral Research Study Withdrawal or Closure

1. To withdraw a study before initial approval has been granted by the IRB, a letter signed by the PI must be submitted to the HRPP. The letter must indicate that the PI is asking for the study to be withdrawn and describe the reason(s) for the withdrawal.

2. To close a study that has received IRB approval but no study procedures have been done, such as enrolling subjects, a letter signed by the PI must be submitted to the HRPP. The letter must indicate that the PI is asking for the study to be closed and the describe the reason(s) for study closure.

3. To close a study that has received IRB approval and has performed study procedures such as enrolling subjects, at least three documents must be provided including a cover letter (1).

4. Completed Study Closure Facepages (2). The Study Closure Facepages can be found on the HRPP website at https://irb.ucsd.edu/SBSStudyCloseFacepage.doc. The Study Closure Facepages include an outline of the documents that need to be submitted for study closure review (green arrow).

5. And a completed Narrative Summary of Progress at Study Closure (3). The Narrative Summary can found at https://irb.ucsd.edu/SBSCloseoutSummary.doc.

6. Additional documents that may also need to be submitted include a copy of the IRB-stamped approved consent(s)/assent(s) currently in use by the project, if the study is obtaining documented consent/assent. Do not send a consent/assent that has been signed by a study participant.

7. As well as a copy of any site monitoring forms, progress reports, audits, and/or publications associated with the project, as applicable, since the last IRB review (initial or continuing).

8. Once you have your Study Closure/Withdrawal documents ready to upload, click on "My Protocols at a Glance" after you have logged in through e-IRB services.

9. Click on the project number link to which you would like to upload the Study Closure/Withdrawal documents.

10. Click on the "Upload document(s) for study closure/withdrawal" link.

11. Begin uploading your documents following the four steps outlined on the "Upload Document Files" page.