Continuing review (CR) is a post-approval review process to evaluate if a research study is being conducted in compliance with the approved protocol. This is necessary to ensure the continued validity of ethics approval and to assure the protection and welfare of research subjects.
In line with Singapore's HBRA requirements and general ethics guidelines, NTU-IRB requires all projects approved under the non-Exempt category (i.e. Expedited/Full Board review) to fulfil the following:
- PIs should submit the Continuing Review Form annually or at intervals appropriate to the degree of risk, until the completion of the study.
- CR is required until the research study is permanently closed to the enrolment of new research subjects, and all research subjects have completed all research-related interventions/study activities and collection, and analysis of individually identifiable data has been completed.
- Upon completion of studies, PIs should submit the Continuing Review Form (by checking the study completion option) at the earliest possible time, but not more than 3 months after study completion.
- PIs may use the Continuing Review Form to report project withdrawals and suspension/termination. This should be reported within 30 calendar days of withdrawal, and 7 calendar days of suspension/termination of the study, respectively.
- Following reviews by IRB, PIs will be notified for CR outcome.
Note: The NTU-IRB will withdraw the approval or suspend/terminate the study if there is wilful non-compliance to the CR process.