IRB Submissions & Review Fees

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.

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.

Full Board Meeting Dates

The 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 type

All 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 amendment
2. Amendment Form: To edit the sections and study documents to reflect the requested changes.

The amendment can initiated in ECOS 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 days
The 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

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 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

Effective from 1 April 2025, for studies initiated by industry or commercial entities, the following review fee would be charged:

• Initial application review involving institution(s) from only one healthcare cluster: S$3,000
• Initial application review involving institution(s) from two healthcare clusters: S$4,000
• Initial application review involving institution(s) from three healthcare clusters: S$5,000
• Subsequent amendments (involving protocol and/or informed consent document amendments): S$300
• Subsequent addition of first site from another healthcare cluster: S$1,000/cluster
• Renewal for submission of study renewal/study reactivation report form: S$1,000

Note:

1. All charges stated above are subjected to prevailing GST.

2. Review fees should be paid and proof of payment should be included at the time of submission.      

- Please attach the proof of payment in the Other Attachments section of the Application, Amendment and Study Status Report Forms.       

- When making payment, include ‘CIRB and [ECOS Form Reference]’ in the PayNow or TT/Giro transaction details, e.g. CIRB 2023-1000-APP1.       

- An invoice would be issued to acknowledge receipt of the review fee and would be sent to the contact person listed in the CRMS>IRB Review Fees Billing Details.