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.
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:
(Including sleep studies)
Health Service Research
Cardiovascular Science Pharmacology
Haematology (including haematological malignancies)
Sports & Rehab Medicine
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.
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
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
Annex G – Research involving children
Annex H – Research involving prisoners
Application part 3: Extra pages for part 1 forms (if required)
Study team members
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
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)
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
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 firstname.lastname@example.org or call 6323 7515.