Study Closures and Withdrawals (Study/Withdrawal Submissions)

Cayuse Human Ethics needs to be updated should a study need to be withdrawn or closed. The status of the study in Cayuse Human Ethics will determine which action can be taken.

Withdrawals

Study Closures

Withdrawals

Withdrawal by PI Request

The PI may inform ORCA at any time that they wish to withdraw an initial application for review of proposed human subject research. This is done using the Withdrawal Submission in Cayuse Human Ethics. Please note: once a withdrawal has been requested, the only way to proceed with a request for IRB review is to create a new study and new initial submission in Cayuse Human Ethics.

Administrative Withdrawal

An application for review of proposed human subjects research may also be administratively withdrawn due to non-responsiveness of investigators. If ORCA sends comments or questions related to an Initial Submission and there is no response from the study investigators after 90 days, the submission may be administratively withdrawn. ORCA will make a reasonable effort to remind the study investigators to respond and/or investigate technical issues.

Creating a Withdrawal Submission

• Log in to Cayuse Human Ethics.
• Find your study on the dashboard in “Approved Studies” and select it. 
• In the top right corner select the “+ New Submission” button.
• Choose “Withdrawal.”
  • If “Withdrawal” is not shown as an option, contact ORCA.
• Select the “Complete Submission” link and follow the instructions to fill out the submission.
• When the submission is complete, follow the instructions for submitting.
• The PI and the Co-PI (if applicable) will be sent emails with instructions for certifying the submission in Cayuse. Once all certifications are entered, the submission will be routed to ORCA.
• Once ORCA has received the submission, you will receive an acknowledgment email. 
• Be sure to check your email (Cayuse will use your @ucsc.edu address) on a regular basis, as you may receive important information and/or questions regarding the submission. 
• You will receive an email from Cayuse once the withdrawal has been processed. 

 Study Closures

An IRB approved or exempt certified study is considered active until approval for it expires or the study is closed. Studies should be closed when all activities involving human subjects described in the IRB-approved/exempt certified study are completed. This includes research-related interaction/intervention with subjects and analysis of identifiable private information (data). Please note: once a closure has been requested for a study, the only way to continue with research activities is to create a new study and new initial submission in Cayuse Human Ethics.

Closure by PI Request

The PI may inform ORCA at any time before expiration that they wish to close an active study. This is done using the Study Closure Submission in Cayuse Human Ethics. 

The Study Closure Submission includes questions to make sure the study is eligible for closure. If you are unsure about whether to proceed with a study closure, contact ORCA before creating a Study Closure Submission.

If the PI leaves the University prior to expiration of the study, the study must be closed or transferred to another eligible UC Santa Cruz PI. Student-led studies must be closed before graduation or departure from UCSC. This is the responsibility of the student’s faculty advisor (PI). 

Administrative Closure

If a renewal for a given study is not submitted prior to the study’s expiration, the study will be administratively closed after expiration. Once a study expires, all study activities involving human subjects must cease. This includes: recruitment, consent, study procedures, analyzing identifiable data, etc.

Creating a Closure Submission

• Log in to Cayuse Human Ethics.
• Find your study on the dashboard in “Approved Studies” and select it. 
• In the top right corner select the “+ New Submission” button.
• Choose “Closure.”
  • If “Closure” is not shown as an option, contact ORCA.
• Select the “Complete Submission” link and follow the instructions to fill out the submission.
• When the submission is complete, follow the instructions for submitting.
• The PI and the Co-PI (if applicable) will be sent emails with instructions for certifying the submission in Cayuse. Once all certifications are entered, the submission will be routed to ORCA.
• Once ORCA has received the submission, you will receive an acknowledgment email. 
• Be sure to check your email (Cayuse will use your @ucsc.edu address) on a regular basis, as you may receive important information and/or questions regarding the submission. 
• You will receive an email from Cayuse once the study has been closed.