Initial Application
Research studies requiring IRB approval must be submitted via ECOS for review. No research activities may be carried out prior to the approval.
An overview of the initial application submission and review process is as follows.
For the initial application, once the form has been declared by the Principal Investigator (PI), it will be automatically routed to the Research Office Checker (ROC) if applicable, Department Representative (DR) and subsequently, the Institution Representative (IR) for endorsement. After which, the form will be submitted to the CIRB.
Once submitted a preliminary review will be conducted on the completeness of the submission and suitability of the review type. For studies that require exemption and expedited review, they will be reviewed by the Board Chairperson. For studies that require full board review, they will be reviewed at the monthly convened meetings at which a quorum is present. Notifications of approval or revisions will be communicated via auto-generated mails from the system.The review type is determined based on the level of risk in which research participants are exposed to. The determination of the type of review is to be made by CIRB. Below is a summary of the information.
1Note: Minimal risk is defined as "the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life, or during the performance of routine physical or physiological examinations or tests." 2Note: This could vary depending on several factors such as the completeness, and quality of the application, complexity of the study and response time to CIRB's queries.
Full Board Meeting Dates
The Board will conduct full board review at a convened meeting monthly (with the exception of the month of December) wherein a quorum is present. A quorum is defined as five members including the Chairperson (a medical practitioner), at least one external Scientific Member and one external Lay Member.
Applications should be submitted with sufficient lead time for the RDO to check if applicable, and for the DR and IR to endorse. A preliminary review to evaluate the completeness of the submitted application will be conducted. This may include requests for additional information and clarifications. Applications received after the first working day or delay in the reply may result in the application being tabled for the subsequent full board meeting.
If you anticipate that your IRB application will require full board review, please observe the submission deadline.
Submission Deadline: 1st working day of the monthPlease note that this deadline is only applicable to research studies that require full board review. Most minimal risk studies are reviewed through the exempted or expedited procedures by the Chairman which occurs on an ongoing basis. This determination will be made by the CIRB.
Amendment / Exemption Amendment FormThe CIRB should be notified of any changes made to the approved applications. No implementation of the changes may be carried out without prior approval. All requests for modification are reviewed by an expedited review procedure unless there have been major changes to the approved applications where the risk/benefit ratio is altered.For exempted studies, unless the changes made alter the exempt status, amendment submission is not required.The amendment form is not required to go through the endorsement process unless the following changes are made to the approved application.• Change in PI/ Site-PI• Addition of study site(s)• Significant changes to protocol• Changes in form typeAll amendment request should be submitted via ECOS for review. The amendment consists of two parts:1. Study Amendment Cover Note: To identify the reason for the amendment2. Amendment Form: To edit the sections and study documents to reflect the requested changes. The amendment can initiated in iSHaRe by any study team member listed in the approved application. After filling the amendment cover note, the system will create the amendment form by copying the approved application/ the last approved amendment form, and opening a copy for editing. The required changes can then be made and submitted to the IRB for review. The submission process is as follows.
Please note that the form can only be submitted by the PI and only one amendment form can be submitted at any one time.
Study Status Report Form
The approval period granted by CIRB for approved applications is one year (12 months). For research studies which will continue beyond one year, the PI must submit a request for renewal via ECOS. It is the responsibility of the PI to submit the study status report form with sufficient time prior to the expiration of the current IRB approval, so that no lapse in the study approval occurs. It is recommended for the form to be submitted at least 2 months (60 days) before the expiry. Note: In the event where the approval has lapsed, both the study status report form and study deviation/non-compliance report form have to be submitted to CIRB.
ECOS will send email and system notifications beginning 3 months (90 days) before the study expiration. The notifications sent are as follows.• 1st Study Expiry Reminder – 90 days prior to expiry of ethics approval • 2nd Study Expiry Reminder – 60 days prior to expiry of ethics approval • Final Study Expiry Notification – 30 days prior to expiry of ethics approval Continuing review of expedited or full board approved applications will be conducted with the same diligence as utilised during the initial review of the research. Continuing review of full board approved applications may be considered for expedited review if (i) the research is permanently closed to the enrolment of new participants, all participants have completed all research-related interventions and the research remains active only for long-term follow-ups, (ii) no participants have been enrolled and no additional risks have been identified or (ii) the remaining research activities are limited to data analysis. For exemption studies, the requirement for continuing review is waived.All renewal requests should be submitted via ECOS for review.
Study Status
Study Status Update should be used when there is an update to the study status. For example, change of study status from “ongoing” to “suspended”. Study Status Update can be submitted at any time.
Study Reactivation
The study reactivation is to be used to re-open a research study which is previously closed or where the approval has lapsed. All studies must retain an active IRB approval in order for research activities to be carried out. Otherwise, all research activities, including screening, enrolment, interventions, and interactions and collection of data and samples, or analysis of data and samples that have already been collected, or use of study data must stop.Review of the form will be conducted with the same diligence as utilised during the initial review of the research
Study Closure
The study closure is to be used for the reporting of study closure, termination or withdrawal. The form is to be submitted to CIRB via ECOS within the following timeframe.
Study Closure – Within 30 days The study may be completed when all research-related interventions or interactions with participants have been completed and data analysis involves only unidentifiable data. For multi-site studies, the study may be closed regardless of the completion status of the global study.
Study Termination – Within 7 daysThe study may be terminated by the PI, Institution or sponsor if the study is stopped after IRB approval.
The submission process for the study status report forms is as follows.
Please note that the form can only be submitted by the PI and only one study renewal form can be submitted at any one time.
Study Deviation & Non-Compliance Report Form
All PIs and the study teams are responsible for reporting information regarding the approved study in a timely manner, understanding and adhering to the reporting timeline.
Any incidence of unplanned excursion from the approved protocol (i.e. deviation) or failure to abide by the CIRB and other applicable regulatory requirements (i.e. non-compliance) should be reported to the CIRB via ECOS as soon as possible but not later than 14 calendar days after 1st knowledge by PI using the Study Deviation/Non-compliance Report form.
The submission process for the study deviation & non-compliance report forms is as follows.
Please note that the form can only be submitted by the PI. Multiple study deviation & non-compliance report form can be submitted at any one time.
Serious Adverse Event (SAE) Report Form
Any serious untoward medical occurrence in participants recruited by any study site that is reviewed by CIRB constitutes a local SAE. Submission of SAE occurred in study sites that is not reviewed by CIRB constitutes non-local SAE (overseas SAE). Both local and non-local SAE should be reported to the CIRB via ECOS using the SAE Report Form. The reporting timeline is available under the "Guidelines" section of the "Forms & Resources" page.
The submission process for the SAE report forms is as follows.
Please note that the form can only be submitted by the PI, Site-PI and Co-I. Multiple SAE report forms can be submitted at any one time.
Other Study Notification (OSN) Report Form
The OSN Report Form is to be used to report to CIRB on the following:
• DSMB Report
• Annual/Interim /Periodic Safety Report
• Interim Data Analysis
• Letter from Study Sponsors
• Other Notification
The submission process for the OSN report forms is as follows.
Please note that the form can only be submitted by the PI. Multiple OSN report forms can be submitted at any one time.
IRB Review Fees
Please note that all charges stated above are subjected to prevailing GST.
