Additional online forms available on iSHaRe e-CIRB

With effect from 13 June 2016, additional online forms necessary for the continuing review of the approved iSHaRe studies will be available in the system.

Please note that we will cease accepting hardcopy submissions for approved iSHaRe studies from 1 July 2016 onwards. All applicable submissions for the continuing review have to be submitted using the online forms available.

For more information on the launch, please click here.

 

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.

With effect from 2 May 2014, the Specialities in the Six Review Boards are as follows: 

CIRB A
CIRB B
CIRB C
Ophthalmology
Psychiatry
Neurology/Neurosurgery
(Including sleep studies)
Geriatric Medicine
Nursing
Health Service Research
Oncology
Cardiovascular Science Pharmacology
Emergency Medicine
Endocrinology
Diagnostic Imaging
Respiratory Medicine
CIRB D
CIRB E
CIRB F
Obs/Gynaecology
Anaesthesia
(including acupuncture)
Surgery
ENT
Dentistry
Gastroenterology
Renal Medicine
Rheumatology/Immunology
Dermatology
Paediatric Medicine
Family Medicine
Genetics
Palliative Medicine
Haematology (including haematological malignancies)
Pathology
Sports & Rehab Medicine
Allied Health
Infectious Disease

 

To find out who your institution representative is, please click here.

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.

 

e-CIRB User Guidebooks

 

 

e-CIRB Quick Reference Guide: Study Renewal Report Form

 

 
e-CIRB User Guidebook: iSHaRe Account Registration
 
 
 
e-CIRB User Guidebook: New Application
 

 
e-CIRB User Guidebook: Department and Institution Representative Endorsement
 


Updated 1 July 2015

Application part 1: Forms
 
e-CIRB Application Form and Exemption Application Form
 
 
 
e-CIRB Application Form and Exemption Application Form (For Reference Only)
 
 


Updated 12 June 2015
Application part 2: Annexes
 
Annex A – Placebo use
 
 
Annex B – COI declaration form
 
 
Annex C – Biological materials storage
 
 
Annex D – Industry sponsored studies
 
 
Annex E – Waiver of informed consent
 
 
Annex F – Research involving pregnant women, foetuses 
                 and neonates
 
 
Annex G – Research involving children
 
 
Annex H – Research involving prisoners
 

 

 

Updated 29 August 2014

 

 Application part 3: Extra pages for part 1 forms (if required)
 
Study team members
 
 
PI declaration
 
 
Study team members’ endorsements
 
 
Department Representative’s endorsement
 
 
Institution Representative’s endorsement
 
 
Characteristics of target study participants
 
 
PI/DR/IR (for exemption application)
 


 
Updated 24 April 2015
Renewal/closure of project (if required)
 
CIRB study status report form
 


 
Updated 11 August 2015
Changes to Study Team Members
 
 
 
Changes to Study Team Members Form 
 
Extra Page for Changes to Study Team Members Form
 
 
Extra Page for Conflict of Interest Declaration
 


 
Updated 21 April 2015
Reporting to CIRB
 
 
 
CIRB Local Serious Adverse Event (SAE) Reporting Form 
 
CIRB Protocol Deviation/Non-Compliance Report Form
 


 
Updated 19 August 2016
Other Templates
 
Amendment summary
 
 
Assent form
 
 
Certification of Translation Template
 
 
Participant Information Sheet & Consent Form
 
 
Protocol template (Clinical Trial)
 
 
Protocol template (Research Study)
 
 
 
Waiver of CITI Certification Form
 
 

 

 

Updated 10 June 2016

 

General Information and FAQs
 
Advertisements for Recruitment of Research Participants
 
 
Data security guidelines for personally identifiable and 
other confidential data in research – electronic data
 
 
Glossary of Lay Terms for Use in Consent Documents
 
 
Retention of Research Data and Records
 
 
Timelines and procedures for reporting SAE-AE
 
 
Use of Thumb-print on Informed Consent Form
 
 
Frequently asked questions (FAQs)
 
 - General
 
Frequently asked questions (FAQs)
 
 - Mutual Recognition of Research Ethics Review
 
 
Frequently asked questions (FAQs) - iSHaRe
 
 
Frequently asked questions (FAQs) - e-CIRB
 

 

 

Updated 25 July 2016

 

 

CIRB Charges

SingHealth researchers are exempted from CIRB charges.

For studies initiated by industry or commercial entities, CIRB charges a fee of:

  • $1,250* (subject to 7% of GST) for each initial CIRB application review
  • $200 (subject to 7% of 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 April 2016, the fee for review of initial CIRB application is $1,250 (subject to 7% GST). [Announcement]

 

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