After IRB Approval

IRB approval does not end a researcher’s responsibilities. Investigators must ensure that all study activities remain consistent with the approved protocol and comply with applicable IRB requirements throughout the life of the study. Any changes, updates, or issues that arise during the course of the research must be reported to the IRB, as applicable.

All post-approval activities, including modifications, continuing reviews (if required), reportable events, and study closures, are submitted through Cayuse Human Ethics.

Throughout the lifecycle of an approved study, researchers are responsible for:

• Submitting modifications for any changes to the approved study 

• Completing continuing reviews when required to maintain IRB approval 

• Reporting unanticipated problems, adverse events, or protocol deviations

• Maintaining compliance with the approved protocol and regulatory requirements 

• Submitting a study closure when all research activities are complete

Modifications

A modification is any change to an approved research study. IRB review and approval of a proposed modification is required before implementing any changes, except when necessary to eliminate immediate hazard to the subjects (which is rare for social and behavioral research).

All proposed modifications must be submitted through Cayuse. For guidance on how to submit a study modification, refer to the Cayuse Human Ethics User Guide.

• For Non-Exempt studies (Expedited or Full Board), all modifications require IRB review and approval prior to implementation.

• For Exempt studies, modifications are only required if the change(s) may impact the study’s exemption status. For additional guidance on Exempt studies, refer to Amendments to Exempt Research.

Continuing Review

The IRB conducts continuing reviews for studies that involve more than minimal risk, as well as certain study-specific circumstances requiring additional oversight. Approval periods are typically up to 12 months, though the IRB may require more frequent review depending on study risk.

Continuing Review (Renewal) submissions should be submitted at least 45 days prior to the study’s expiration date. Researchers will receive reminders from Cayuse via email if continuing review is required.

• IRB approval must remain active in order to continue research activities. This includes data collection and analysis of identifiable data, unless the dataset has been fully de-identified (including destruction of any key linking identifiers).

• If IRB approval expires (lapses), all research activities must stop. This includes enrollment, data collection, and analysis of identifiable data, except in situations where stopping would jeopardize participant safety.

 For guidance on submitting a Continuing Review (Renewal), refer to the Cayuse Human Ethics User Guide.

Reportable New Information (RNI)

Researchers are required to report certain events or issues to the IRB as Reportable New Information (RNI). This includes:

• Adverse events involving physical, psychological, social, or economic harm

• Unanticipated problems or risks to participants or others 

• Protocol deviations or noncompliance 

• A significant participant complaint

• Data security breaches or loss of confidentiality (e.g., theft of a laptop)

When a researcher becomes aware of RNI, it must be reported promptly through Cayuse Human Ethics as an Incident. Timely reporting of incidents allows the IRB to assess risk and determine whether additional actions are necessary. For guidance on how to report an incident, refer to the Cayuse Human Ethics User Guide.

If you are unsure whether an event qualifies as reportable, contact RIC at researchcompliance@smu.edu.

Study Closure

A study closure must be submitted once all research activities involving human subjects are complete.

A study should be closed when:

• The research is permanently closed to enrollment,

• All participant interactions and interventions are complete,

• Collection of private identifiable information is complete, and

• Analysis of private identifiable information is complete.

Once a study is closed, no further human subjects research activities may occur under that protocol. If you wish to enroll new participants or otherwise continue human subjects research after closure, a new application must be submitted.

After study closure, analyses of de-identified data or specimens and manuscript preparation may continue indefinitely. 

For guidance on closing a study, refer to the Cayuse Human Ethics User Guide.

Leaving SMU or Transferring Research

If you are graduating, leaving SMU, or planning to transfer your research, it is important to plan ahead prior to your departure.

If you will no longer have a formal affiliation at SMU, your SMU IRB approval will no longer remain active. The SMU IRB will not be able to provide ongoing oversight, and you will lose access to Cayuse to manage your study.