Announcements

13 July 2017 – CIRB Updates

Removal of Categories 7 to 10 in the Exemption Application Form

Studies which fall under Categories 7 to 10 would no longer require IRB review with effect from 14 Jul 2017. Please note that CIRB will cease accepting exemption application forms submitted under these categories.

For more information, click here​.

Revision to the Participant information Sheet and Informed Consent Form Template
The template has been revised to be compliant with the Human Biomedical Research Act (HBRA). The latest version can be found under the “Templates” section below. There may be further changes to the template when the subsidiary legislations under the HBRA are released. 

For the summary of changes made, click here​.

Updated Definition of Study Status for Continuing Review 
The definition for the following statuses have been updated for further clarity:
  • Data analysis only – The remaining research activities are limited to data analysis of identifiable data.
  • Completed – There will be no more research activities, including contact with participant or any data analysis of identifiable data (For multi-centre studies, the study may be said to be completed at the sites when no further data will be collected from the sites, regardless of whether the global study has been completed or not.).
Please note that research activities involving the analysis of unidentifiable data does not require continuing review. The study can be deemed to be completed.

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About SingHealth-CIRB

SingHealth Centralised Institutional Review Board (CIRB) shoulders the responsibility of approving, monitoring and reviewing biomedical and behavioural research involving humans. Among other aspects, CIRB performs a risk-benefit analysis to determine if research should proceed.

 

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 schedule, 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: https://www.citiprogram.org/.

The minimum training for Principal Investigators and Site-Principal Investigators conducting clinical trials within SingHealth includes completing the Singapore Guidelines for Good Clinical Practice programme (SG-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 SG-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, CIRB charges a fee of:

  • $1,500* (subject to prevailing GST) for each initial CIRB application review
  • $200 (subject to prevailing GST) for each subsequent amendment

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.

*Effective from 1 May 2017, the fee for review of initial CIRB application is $1,500 (subject to prevailing GST). [Announcement]

 

Contact Us

For enquiries, please contact SingHealth-CIRB at irb@singhealth.com.sg or call 6323 7515.

 

CIRB Forms and Templates 

Online Submission

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



 

Hardcopy Submission

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


     

 

Templates

 
Amendment Summary
 
 
Certification of Translation
 
 
Protocol (Clinical Trial)
 
 
Protocol (Research Study)
 
 
Participant Information Sheet & Consent Form
 
 
Child/ Participant Assent Form  
 
 
 
Waiver of CITI Certification Form
 
 

 

 

Guidelines

 
Advertisements for Recruitment of Research Participants
 
 
Data Security Guidelines for Personally Identifiable and 
Other Confidential Data in Research – Electronic Data
 
 
   
Retention of Research Data and Records
 
 
Use of Thumb-print on Informed Consent Form
 
 

 

Resources

e-CIRB User Guidebook: iSHaRe Account Registration
 
 
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
 
 

 

Frequently Asked Questions

FAQ: General
 
 
FAQ: Mutual Recognition of Research Ethics Review
 

     

FAQ: iSHaRe e-CIRB

 

 

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