Managing Your Existing Study Application

The Principal Investigator, Co-PI and Primary Contact have access to follow the status of application submissions in Cayuse by logging into the study. Application status can be viewed near the top left corner of the application as follows:

• Unsubmitted – Application has not been submitted for review
• Awaiting Certification – Application process is incomplete. The PI must log into the study and click on complete submission, confirm and certify to complete the submission process for the application to be reviewed.
• Awaiting Org Approval – Application is awaiting review by the IRB Committee member from your department or unit
• Reopened – Application has been reviewed and edits are pending from the PI. Refer to letters tab for required changes
• Approved – Application has IRB approval and research may begin
• Withdrawn – Application is no longer active. A new application will need to be submitted.

• Modification – Principal Investigators are required to submit a Modification application in Cayuse for any change in the study protocol, including faculty advisor, primary contact, researchers, purpose and significance, participants, recruitment, methodology, consent, confidentiality or incident.

Examples include:

• Adding or removing investigators or research assistants to or from team
• Changing the recruitment process from flyers to email notification
• Changing the data collection from in-person interviews to interviews via telephone or internet (e.g., zoom)
• Adding a focus group to the data collection process
• Expanding the participant inclusion criteria for any reason

Changes in the study protocol may not be implemented prior to IRB approval of the application for modification of the study.

• Renewal - Principal Investigators are required to submit a Renewal application in Cayuse, annually, on or before the anniversary of the approval date of the initial study as long as research or data is still being collected or where the remaining research activities are limited to data analysis.

It is the responsibility of the PI to verify that IRB training certificates are current for all research team members and to attach updated (renewed) certificates when needed.

If any changes will take place for the continuation of the study, a Modification application must also be submitted.

If a Principal Investigator is unsure if an IRB protocol needs to be renewed, consider the following questions:

• Will continuing research activities involve obtaining data through intervention or interaction with human subjects?
• Will continuing research activities involve obtaining identifiable private information about living individuals? Information is identifiable if subjects can be identified directly or through identifiers linked to subjects. This includes any lists of participants that have not yet been destroyed.
• Will continuing research activities include analyzing identifiable private information about living individuals?

If the answer is YES to any of these questions, a Renewal application must be submitted.

Once all data has been collected and de-identified, a Closure application should be submitted.

• Closure - Principal Investigators are required to submit a Closure application in Cayuse when:
  • Data collection has concluded and all use of identifiable data has been completed; or
  • A previously approved study was not and will not be initiated; or
  • A previously approved study was discontinued prior to its completion.

If a PI fails to renew an application that has expired, the IRB Administrator may Administratively Close applications when there is no response from the Principal Investigator for more than 30 days.

Once a study is closed, it cannot be reopened.

Once a study is closed, research personnel may continue to perform data analysis, manuscript preparation, and publication activities, so long as identifiable information is not being accessed. If an investigation wishes to use identifiable information after a study has been closed, an application for approval of a new study must be submitted to the IRB.

Closed applications are archived in Cayuse, under the Archive tab.

• Withdrawal – Principal Investigators may withdraw an unsubmitted application in Cayuse at any time, especially if an application has been started, but not submitted within 90 days, or not approved. Or, if it is decided that research will not take place. Keep in mind that once a study is withdrawn, it cannot be reopened.

The IRB Administrator may Administratively Withdraw applications when there is no response from the Principal Investigator for more than 90 days.

• Delete – Principal Investigator may delete an application in Cayuse any time prior to application approval.
• Incident Report – Principal Investigators are required to contact the IRB Administrator as soon as possible at irb@sandiego.edu and submit an Incident Report in Cayuse when an unanticipated problem involving risk to subjects or another unexpected event occurs. (For example, a minor participated in your study which was approved for adult participants only.)

If any changes in the study protocol need to take place as a result of the incident, then a Modification application must also be submitted.

For any questions regarding managing your existing IRB approved study, please contact the IRB at irb@sandiego.edu.