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CIRB Frequently Asked Questions (FAQs)

Last updated: 24 Dec 2021​

General Enquiries

​"De-identified data" refers to a data set from which personal identifiers have been extracted, which will disallow re-association with any of the people mentioned in the original record. It should be noted that de-identified data sets often contain a newly created unique identifier completely separate from any identifying characteristics in the original study data sets. This created identifier is not capable of being translated so as to identify the individual except through a Record Linkage Data, which links the created unique identifier with an established identifier.  The record linkage data should be held by an individual who is not in the study team.

"Anonymised data" refers to a data set that has removed all direct identifiers and cannot be re-associated with the data or underlying individuals.

(SHS-RSH-OOR-CWP-202 SingHealth Cluster Research Data Management Policy – This document is strictly for internal use by SingHealth Staff)

CIRB Review

​Research as defined under 45 CFR 46.102 (l) refers to systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

All research application must be reviewed and receive approval before research begin. For research using existing data and previously collected human tissue samples for secondary research, the secondary research should only be initiated after you have received the IRB’s approval.

Activities that do not fall within the definition of “Research” may not be submitted to CIRB for review. Please refer to the Table for Differentiating Research from Other Research-like Activities for more information.

​Studies involving three or more patients (case series) will require CIRB review. Case report of one to two patients does not meet the definition of research as it does not involve “systematic analysis/ investigation”. Hence, CIRB review is not required for case report of one to two patients.


Case report refers to case report write-up or reporting of individual patient’s clinical results.

Activities designed to determine if aspects of medical practice are in line with established standards are called quality assessments. When an activity is designed to improve the performance of medical practice in relation to an established standard, it is called quality improvement. These projects do not require CIRB review.

Any QA or QI activity where participants are subjected to additional risks or burdens beyond usual clinical practice will be reviewed as research. Please refer to the Table for Differentiating Research from Other Research-like Activities for more information.

If the QA/QI study is determined to have both research intent and assessing QA/QI objectives by the PI, this will be reviewed as research as it has research intent.

Click here (This document is strictly for internal use by SingHealth Staff members) for the "Checklist for Quality Assurance (QA)/ Service Improvement (SI) projects"

 

• Approval: IRB has reviewed and given approval the study or its amendments.
• Not Approve: IRB has reviewed and did not approve the study or its amendments.
• Review Not Required: IRB has reviewed and determined that the proposed study doesn’t meet the definition of human subject research. Hence, it is outside the purview of CIRB. However, Principal Investigator should seek Institution’s advice with regards to compliance with other applicable guidelines and regulatory requirements.
• Acknowledgment: IRB has reviewed and acknowledged the submission

Activities that do not fall within the definition of "Research" can be published. However, the project should not be described as research.

Amendment cannot be made to a study with a status “Review Not Required” on iSHaRe.

Changes to study team members or the study timeline do not require CIRB’s review. However, changes to the application and/or study that may affect the determination of ethics requirement should not be initiated without prior approval by CIRB, e.g. changes to study procedures which the study now meets the definition of human subject research which require CIRB’s review through the submission of CIRB Application Form or Exemption Application Form.

The CIRB consent form template must not be used for studies or projects with a status “Review Not Required” (IRB has determined that further ethical review is not required) on iSHaRe.

Submission to CIRB

​​Please refer to CIRB Submissions & Review Fees page for the submission deadline and review process.

​Please refer to CIRB Initial Application Checklist on CIRB website. This document serves to facilitate the study team and the RDO in preparing the CIRB application.

​All research activities that will be carried out as part of the research study should be clearly described in the CIRB Application Form (Section F10) with the following details:
• WHAT are the research activities that will be carried out?
• WHO will be carrying out each of these research activities?*
• WHERE these research activities will be carried out?
• WHEN these research activities will be carried out?
• HOW these research activities will be carried out?


*It is only required to state the institution’s name, not names of the individuals.


Example: (Institution X) study team will conduct informed consent discussion with the potential participants and extract clinical information from medical records. (Institution Y) will conduct in-depth interview with the participants.


It is important to note that responses to Section F10 should be different from Section F8. Unlike Section F10 which details all activities that will be carried out as part of research in the study, Section F8 should only describe the experimental design and procedures to be used to accomplish the specific aims of the research study.

Please make the necessary changes on the CIRB Amendment Form and submit on iSHaRe. All proposed changes to the research and the rationale for the change must be listed on the Study Amendment Cover Note.
Please remove the previous version and replace it with the clean and “track changed” version of the revised document. You may also submit the summary of change for the revised document (if any).

​Please make changes under Section E, other sections affected (if any) as well as study documents revised as a result of the change and submit the Amendment Form on iSHaRe.

CIRB Review Fee

Study Team Members and Study Site

With effect from 12 Feb 2015, the following study personnel should be listed as study team members* and submitted for CIRB review and approval.  The study team members should only carry out research-related activities upon obtaining approval from CIRB. 

• Co-investigators - An individual of the research/ clinical trial team who is designated and is under the direct supervision  of the Principal Investigator/Site-Principal Investigator at the study site to perform study-related procedure and/or make important research-related decisions.

• Study Team Members - An individual who is directly involved in a research study which is under the direct supervision of Principal Investigator/Site-Principal Investigator at the study site. For example:
- Performing intervention or having interaction with participants
- Obtaining and/or handling identifiable research data about the participants
An individual who does not have direct interventions/interactions with subjects or handle identifiable subject data need not submit to CIRB for approval of his/her participation.

• All personnel who have a responsibility for the consent process and/or direct data collection for the study must be listed as study team members (e.g. Co-investigators and Study Team Members). 

*The Principal Investigator and/or Site-Principal Investigator should determine if the study personnel meets the definition of study team members (Co-investigators and Study Team Members).

The following individual should not be listed as study team members*:

• Individual who does not have direct intervention/interaction with subjects or does not handle identifiable subject data need not submit to CIRB for approval of his/her participation.

• Individual’s whose role in the study is part of his/ her regular duties (i.e. radiographer, imaging technologist) and involvement in the study is limited to performing those duties without contributing to the study goal.

• External Collaborator(s) who are not involved in the conduct of the research at the SingHealth research site or the research site seeking CIRB’s approval. The roles and responsibilities of these collaborators should be addressed through an agreement, e.g. Research Collaboration Agreement (RCA) or a Project Agreement (PA). 

• Contributor of human biological materials to a study or an individual who received human biological materials is not considered a study team member unless the individual is directly involved in the research study. Any transfer of material should be documented, e.g. Material Transfer Agreement (MTA).

• Collaborator(s) who are involved in analysis of de-identified data.

*The Principal Investigator and/or Site-Principal Investigator should determine if the study personnel meets the definition of study team members (Co-investigators and Study Team Members).

Please make changes under Section B2, update Section C of the CIRB Amendment Form and submit on iSHaRe.

The minimum training requirement for Study Team Members who are from SingHealth & Partner Institutions is completing the Collaborative Institutional Training Initiative (CITI) Certificate for Biomedical Research Investigators and Key Personnel programme. You could access the CITI programme from this link: https://www.citiprogram.org/.

Please click here for the list of the core modules for the CITI certificate.

The minimum training for Principal Investigators conducting clinical trials within SingHealth & Partner Institutions includes completing the local Good Clinical Practice programme (GCP) workshop (in addition to the current requirement for CITI) when making a submission to the CIRB. For clinical trials regulated by HSA, CIRB will not grant ethics approval for clinical trials applications until a receipt of proof for the Principal Investigators' completion of the local GCP course is provided.

To attend the local GCP workshop, you can register with any local institution which offers it, such as SingHealth Academy, National Healthcare Group (Classroom-based or Online) National University Health System (NUHS), and the online iGCP course with National University of Singapore.  

Note: Study Team Members who are not from SingHealth & Partner Institutions are encouraged to complete the CITI online course. However, if you wish to request for waiver of this requirement, please attach a copy of the Waiver of CITI Certification Form in place of the CITI completion report.

​There is no requirement to sign and date the CV before submission to CIRB.
However, the CV submitted should be up-to-date CV.

​CIRB does not use the term “Satellite Site”.

If the site is engaged in research, it should be added as a study site. Please indicate in Section B1 and appoint a site-PI in Section B2 of the CIRB Application Form/ Amendment Form.

If the site is acting as a service provider, there is no need to include it as a study site. However, please do check with the site if the institution requires the site to be listed as one of the study site.

Informed Consent

Study Closure

The study may be completed when all research-related interventions or interactions with participants have been completed and data analysis involves only unidentifiable data.  The study is considered completed if there are 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 (e.g. after database locked), regardless of whether the completion status of the global study has been completed or not.

The Principal Investigator should submit Study Closure Report Form on iSHaRe within stipulated timeline as stated below:
• Study Completion – within 30 days after completion of the study.
• Study Withdrawal – within 7 days.
• Study Termination by Institution, Principal Investigator or Sponsor - within 7 days.
Please refer to IRB Submissions & Review Fees page under Study Closure Report Form for more information.

Serious Adverse Events (SAEs)

SAE that are related to participation in the research study (study drug, study intervention, test article administration, study procedures) needs to be reported to CIRB.

Please refer to the CIRB Reporting Requirement and Timeline for Serious Adverse Events (SAE) on CIRB website for more information.

​Reporting of non-local SAEs should commence immediately upon approval. Non-local SAEs refers to SAEs occurring in participants recruited by sites that are not reviewed by CIRB.

However, should any new safety concern surface from individual reports or aggregate analysis of SAE during the application review period, the Principal Investigator should ensure that the new safety information is promptly communicated to CIRB by email so that the information can be considered in the benefit-risk assessment of the study. 

​The Principal Investigator may cease to submit non-local SAEs after the submission of study closure report form.

​There is currently no requirement for submission of such documents. However, CIRB may request for these reports to be submitted when deemed necessary.

Retention of Data and Records

Research data should be retained in a secured storage facility for a minimum of 7 years after completion of research study or date of publication of the research using the research data, whichever is later.

(SingHealth Cluster Research Data Management Policy - Clinical Trial and Clinical Research – This document is strictly for internal use by SingHealth Staff members)

These documents should be retained by the Principle Investigator in a secure storage facility. They should be accessible for inspection and copying by authorised authorities.

Clinical Trials
According to ICH GCP E6 (R2), the essential documents should be retained until:
•at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region; or
•at least 2 years have lapsed since the formal discontinuation of clinical development of the investigational product;
•These documents should be retained for a longer period if required by the applicable regulatory requirements or by an agreement with the sponsor.

Essential documents are documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. For a list of the essential documents required to be maintained for the conduct of a clinical trial, please refer to sections 8.2, 8.3 and 8.4 of the ICH GCP E6 (R2).

Note: For CIRB-approved studies, where the application has indicated that the retention period is 6 years, there is no requirement to submit an amendment to update the storage of research data and records from 6 to 7 years. However, study sites are required to ensure that all research data and records are kept for at least 7 years after study completion or date of publication of the research.

Advertisement/Recruitment Materials

​When direct advertising (including, but not limited to newspaper, posters, bulletin boards, flyers, brochures, email messages, Institutions’ websites, Institutions’ social media platforms, studies’ websites, invitation letters to potential participants, etc.) is to be used, CIRB will review the information contained in the advertisement and the mode of its communication. All advertisements cannot be displayed or used until CIRB has reviewed and approved the final version.

CIRB review and approval is not required in the following cases:
•Letters to doctors for referring potential participants
•Stories in newspapers or magazines that mention the research project
•Listing of clinical trials on research website when the format is limited to basic trial information such as protocol title, purpose of study, protocol summary, basic eligibility criteria, study site location and how to contact site for further information

Please refer to the Guidelines: Advertisements for Recruitment of Research Participants on CIRB website for more information.

iSHaRe

For SingHealth staff, you can log in to iSHaRe portal using your ADID and password.

For non-SingHealth staff, you will need to create an account using your official email address at the iSHaRe login page first before you can log in to iSHaRe portal.

​Firstly, please log in to iSHaRe portal. From the dashboard: (a) Click on "CIRB" from the Shortcuts column on the left of the page; and (b) Select "New Application".

​The "Delete" link is available at the study workspace. Only the PI named on the application can delete the application from the system. This is to ensure that no study will be accidently deleted by other study team members.

If you are unable to find your study team members in the search list, it could be due to the following reasons:
a. User has not created an iSHaRe account
b. User has not login to iSHaRe to complete the user profile set-up after creating the account in SSAM.
c. User has not logged in for more than 183 days and the account has been deactivated. User to email the iSHaRe Administrators for assistance at ishare@singhealth.com.sg using his/her registered email address with following information:
- Domain and Login ID
- Reason for Access
- Current Institution or Organization
- Current Department
- Current Designation

After you have submitted your study, you can retrieve it from the “Study Listing” by selecting the study you are interested in. When the form loads up, click on the “Endorser” icon on the top left of the page. You will be able to see the endorsement stage your application is at.

​Modifications to the application are allowed before PI performs the PI declaration. Once the PI has performed the declaration, the form will be locked. Any further changes will only be allowed if Department Representative (DR)/ Institution Representative (IR)/ Research Department Office (RDO) raises queries to the PI or if the application is rejected.

There are many stages of declaration and endorsements.  The application will only reach CIRB after all the Department Representatives (DRs) and Institutional Representatives (IRs) of all the sites involved (if it is a multi-site study) in the study have endorsed the application. Please refer to IRB Submissions & Review Fees page for the IRB Submission.

Protocol Deviation/Non-compliance

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 CIRB. The Principal Investigator should be reported to CIRB immediately by submitting Protocol Deviation/Non-compliance Report Form.

Please refer to IRB Submissions & Review Fees page under Protocol Deviation & Non-Compliance Report  Form for more information.

Each event should be submitted using one Protocol Deviation/Non-compliance Report Form.

However, if the same event happened to a few participants, the Principal Investigator can describe the event and list the affected participants’ identifiers in one Protocol Deviation/Non-compliance Report Form.