19 May 2020 – CIRB Updates

The updates include:
- Study Closure for Exemption Study
- Assessment of the Suitability of the Research Site by Department Representative/HOD and Institution Representative
- Revamped Participant Information Sheet and Consent Form Template
- iSHaRe Enhancement – Form Changes
- Updated Reporting Requirement and Timeline for Serious Adverse Events (SAE)
- Study Expiry Reminder Notifications
- Removal of Version Date and Version Number from Attachment Upload Component on iSHaRe

Click here for details.

28 April 2020 – Submissions and notifications during COVID-19 Situation

Additional questions and clarifications have been added to the CIRB Updates released on 7 Apr 2020. Click here for details.


7 April 2020 – Submissions and notifications during COVID-19 Situation   

The CIRB Updates provide important clarification on CIRB’s requirements on the following during COVID-19 situation:
i) Changes to the research protocol that require CIRB’s review and approval prior to implementation.
ii) The reporting of Protocol Deviation/Non-compliance and Local Serious Adverse Event.

Click here for details.

24 March 2020 – Duke-NUS & SingHealth Collaborative Research Ethics Review
- NUS has appointed SingHealth Centralised Institutional Review Board (CIRB) for ethics review on collaborative research with SingHealth Institution(s) where Duke-NUS is involved.
- With effect from 1 April 2020, new collaborative studies that involve Duke-NUS and SingHealth Institutions can be submitted to CIRB. The lead PI can be from Duke-NUS or SingHealth Institution.
- The details can be found in the “FAQ: Duke-NUS & SingHealth Collaborative Research Ethics Review” document. Researchers should follow the guidance provided.

1 November 2019 – CIRB Updates
 The updates include:
- Changes to the review requirements of Tissue Banking Protocol
- Changes to the review requirements of studies involving human tissue donation with no specific research activities
- Clarification of the roles and responsibilities of study team members who should be included
- Submission of Human Biomedical Research Study Determination Checklist for new applications

Click here for details.

13 September 2019 – CIRB Updates
 The updates include:
- Updated Clinical Trial Protocol and Study Protocol Template
- Initial Application Checklist
- Updated CIRB FAQs
- Updated FAQs for the mutual recognition of ethics approval between SingHealth CIRB and NHG DSRB
- Principal Investigator’s response timeline

Click here for details.

11 July 2019 – CIRB Updates
For more information on the changes to iSHaRe and information not required for CV submission, click here.

28 May 2019 - Research regulated under Human Biomedical Research Act (HBRA)
Is your research regulated under the HBRA? Does the consent obtained meet the HBRA requirements?
Please click on the following links to download the guidance and checklists.
- Guidance on the Requirement of Appropriate Consent for the Conduct of HBR and Handling of Human Tissue (MOH, 17 May 2019)
- Human Biomedical Research Study Determination Checklist (superseded)
- Appropriate Consent Checklist
- Core and Situational Elements Consent Checklist

22 November 2018 - CIRB Updates

(a) Human Biomedical Research (Exemption) Regulations 2018
The regulation has come into operation on 1 November 2018. For the guidance on the consent requirements for existing HBR, click here (removed).

(b) Revised Participant Information Sheet and Informed Consent Form Template v11
An updated version of the template is available. Please refer to the “Templates” section below. For the summary of changes, click here.

13 February 2018 – Conversion of Paper Studies to iSHaRe studies

Previously approved hardcopy studies with expiry date from 1 Aug 2018 to 31 Jul 2019 would need to be converted in iSHaRe. This allows for the streamlining of submission and review processes and also allows Institutions, investigators and research administrators to access and monitor all the approved studies more effectively.

For more information on the conversion exercise, click here.

For a list of frequently asked questions, click here.


About SingHealth-CIRB

The SingHealth Centralised Institutional Review Board (CIRB) is the central ethics review board within SingHealth to protect the rights and welfare of human subjects involved in biomedical and behavioural research activities being conducted under its authority.  It is responsible for approving, monitoring and reviewing biomedical and behavioural research involving humans. .


CIRB Application Process

In general, there are two types of reviews. The review type is based on the level of risk in which research participants are exposed to:

  • Research studies that involve more than minimal risk are reviewed under the Full Board Review.
  • Research studies that involve minimal or less than minimal risks are reviewed under the Exemption or Expedited review.

Minimal risk is where 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. The determination of the type of review is made by CIRB.

Please click here to view the Submission Workflow.


Full Board Review (New Applications/ Amendments/ Renewals/ Re-table studies)
The CIRB review board meets once a month. The submission deadline for Full Board Reviews (studies with more than minimal risk and major amendments) is the first working day of each month.*

For new applications, the Principal Investigator should submit with sufficient lead time for the Research Development Office check (if applicable), Department Representative and Institutional Representative to endorse prior to the first working day of the month. Submissions received by CIRB after the first working day may be tabled for the subsequent full board meeting.

For example, applications to be reviewed at the meeting in July 2015 must reach CIRB by 01 July 2015.

For CIRB's Full Board Review meeting, please click here.

* With the exception of the month of December when there is no full board meeting.


Exemption and Expedited Review

Study applications or amendments (that involve minimal or less than minimal risks) may be submitted at any time.

All new applications under these categories accepted by the CIRB will be reviewed within 30 calendar days from the date of receipt. #

Exemption may be determined only by the CIRB. Determination of exemptions are not to be made by the investigator. Exemption waives the need for continuing review by the CIRB. However, changes to the study which may alter its exempt status must be resubmitted to the SingHealth CIRB for review. No human biomedical research may be initiated until formal written concurrence of exemption from the SingHealth CIRB has been obtained.

# This could vary depending on several factors such as the completeness, and quality of the application, complexity of the study and response time of the Investigator to CIRB's queries.


Training Requirements
The minimum training requirement for SingHealth study team members is completing the Collaborative Institutional Training Initiative (CITI) Certificate. The required programme is Biomedical Research Investigators and Key Personnel. You could access the CITI programme from this link:

The minimum training for Principal Investigators and Site-Principal Investigators conducting clinical trials within SingHealth includes completing the Local Good Clinical Practice programme (local GCP) workshop (in addition to the current requirement for CITI) when making a submission to the CIRB. For clinical trials that require a Clinical Trial Certificate from HSA, CIRB will not grant ethics approval for clinical trials applications until a receipt of proof for the Principal Investigator completion of the local GCP course is provided.


Submission to CIRB                           
Submissions of approved IRB application (before 15 September 2014) for continuing review or reporting to CIRB is to be submitted via hardcopy.

The e-CIRB is a web-based submission system in iSHaRe for researchers to submit their research protocols for ethics approval. With the launch of the system on 15 September 2014, all new IRB applications with effective from this day onwards, is to be submitted online via the system. Please click here for the FAQ: iSHaRe e-CIRB.


CIRB Charges

For studies initiated by industry or commercial entities, the following review fee would be charged:

  • Initial application involving Single Cluster institution(s) - S$1,750* 
  • Initial application involving Cross Cluster institution(s) - S$2,750*
  • Subsequent amendments - $200  
  • Subsequent site addition from Cross Cluster institutions - S$1,000

Please note that all charges stated above are subjected to prevailing GST. 

Payment must be by cheque made payable to “Singapore Health Services Pte Ltd”. The completed application form, the cheque and a cover sheet (stating the full protocol title, PI’s name, department and designation, and the sponsor’s name and address for receipt) must be submitted to the relevant CIRB.

*With effect from 1 April 2018, the review fee for initial application will be adjusted. [Announcement]


Contact Us

For enquiries, please contact SingHealth-CIRB at or call 6323 7515.


CIRB Forms and Templates 

Online Submission

e-CIRB Forms


iSHaRe Enhancement – Form Changes

e-CIRB Application Form/ Exemption Application Form (For Reference Only)

Initial Application Checklist

Restricted Human Biomedical Research Form

Non-Local SAE Reporting Form



Hardcopy Submission

CIRB Study Status Report Form
CIRB Protocol Deviation/ Non-Compliance Report Form
CIRB Local Serious Adverse Event (SAE) Reporting Form
Changes to Study Team Members Form
Principal Investigator’s Declaration Form
Department Representative’s Endorsement Form
Institution Representative’s Endorsement Form


                                                                                                                            Updated 17 September 2019    


Amendment Summary
Certification of Translation
Protocol (Clinical Trial)

Participant Information Sheet & Consent Form 


Guidance on Requirements For Informed Consent Documents 


Participant Information Sheet & Consent Form

(Videography & Photography)


 Summary of Changes: Participant Information Sheet & Consent Form (Videography & Photography) (version 3 to 4)
 Child/ Participant Assent Form  
 Waiver of CITI Certification Form

Type of Study Determination Form
(previously known as Human Biomedical
Research Study Determination Checklist)
 Appropriate Consent Checklist 
 Core and Situational Elements Consent Checklist

 Updated 17 September 2019


Advertisements for Recruitment of Research Participants
Use of Thumb-print on Informed Consent Form

Waiver of Consent for Research Regulated by HBRA 



Reporting Requirement and Timeline for SAE  


Updated 15 May 2020


e-CIRB User Guidebook: New Application

e-CIRB User Guidebook: Department and Institution
Representative Endorsement

e-CIRB Quick Reference Guide: Study Renewal Report Form

e-CIRB Quick Reference Guide: CIRB Comment

Glossary of Lay Terms for Use in Consent Documents


  Updated December 2016

Frequently Asked Questions

FAQ: General

FAQ: Mutual Recognition of Research Ethics Review


FAQ: Duke-NUS & SingHealth Collaborative Research Ethics Review





 ​​​​​​​ Updated 9 April 2020