UCSD Human Research Protections Program

How to Submit a 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 The letter must indicate that the PI is asking for the study to be withdrawn and describe the reason(s) for the withdrawal. Upon receipt of the letter, the IRB Director, Associate Director, or HRPP staff designee will review the submission for completeness. A request to the PI may be made to clarify any questions or to provide additional information. Once any answers to questions and/or additional information has been submitted, the study withdrawal submission will be reviewed by the IRB Chair, or by the IRB Chair's designee, and the PI will be provided with written notice of the review of the withdrawal and/or acceptance of the withdrawal, as appropriate.
  2. To close a study that has received IRB approval, but no study procedures have been done, such as enrolling participants, a letter signed by the PI must submitted to the HRPP. The letter must indicate that the PI is asking for the study to be closed and describe the reason(s) for the study closure. Upon receipt of the letter, the IRB Director, Associate Director, or HRPP staff designee will review the submission for completeness. A request to the PI may be made to clarify any questions or to provide additional information. Once any answers to questions and/or additional information has been submitted, the study closure submission will be reviewed by the IRB Chair, or by the IRB Chair's designee, and the PI will be provided with written notice of the review of the closure and/or acceptance of the closure, as appropriate.
  3. To close a study that has received IRB approval and has performed study procedures such as enrolling participants, PI completed Study Closure Facepages and Narrative Summary of Progress at Study Closure must be provided to the HRPP. For Biomedical studies, the Biomedical Study Closure Facepages and Narrative must be used. For Social and Behavioral studies, the Social and Behavioral Study Closure Facepages and Narrative must be used. These forms can be found on the HRPP website Forms page. In addition, copies of relevant associated information, such a copy of the stamped,approved consent if participants have been enrolled since the last review by the IRB (initial or continuing), formal study closure from the sponsor, site monitoring reports, audits, other reviews, etc. must also be submitted for review. The Study Closure submission must be submitted within 30 days of study closure. For more information, see the HRPP fact sheet, Closure/Withdrawal of Study . The study closure submission will be reviewed by a convened IRB, IRB Chair, or by the IRB Chair's designee, and the PI will be provided with written notice of the review of the closure and/or acceptance of the closure, as appropriate.

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