Last updated: 9 Nov 2023
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.• Not Human Subject Research: 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 “not Human Subject” on ECOS.
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 IRB Application Form.
The CIRB consent form template must not be used for studies or projects with a status “not Human Subject Research” (IRB has determined that further ethical review is not required) on ECOS.
Please refer to IRB Submissions & Review Fees page for the IRB Review Fees.
Please refer to CIRB Submissions & Review Fees page for the submission deadline and review process.
All research activities that will be carried out as part of the research study should be clearly described in the IRB Application Form (Section E3 or G7) 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.
The following study personnel should be listed on the Application/Amendment Form and submitted for CIRB review and approval. They should only carry out research-related activities upon obtaining approval from CIRB.
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 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 GCP course is provided.
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 and appoint a site-PI in Section B2 of the IRB 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.
The following table summarises when a witness or an impartial witness is required during an informed consent process:
1 Human Biomedical Research that is not interventional, not invasive and not restricted research does not require witness during the informed consent discussion. 2 Impartial witness - A person who is 21 years of age or older, has mental capacity, who is independent of the research study, and cannot be unfairly influenced by people involved with the research study3 Witness - A person who is 21 years of age or older, has mental capacity, who may be/ may not be a member of the team carrying out the research
For research under the scope of HBRA, Informed Consent is required unless the research meets the requirements under HBRA Fifth Schedule Part 2, Section 3. Waiver of Informed Consent may be granted by CIRB if a research proposal meets the requirements under HBRA Fifth Schedule Part 2.
For details on waiver of requirement for appropriate consent for emergency research, please refer to HBRA Fifth Schedule Part 3.
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 Status Report Form on ECOS within stipulated timeline as stated below: • Study Completion – within 30 days after completion of the study.• Study Termination by Institution, Principal Investigator or Sponsor - within 7 days. Please refer to IRB Submissions & Review Fees page under Study Status Report Form for more information.
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 status report form to close the study.
There is currently no requirement for submission of such documents. However, CIRB may request for these reports to be submitted when deemed necessary.
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 Study Deviation/Non-compliance Report Form.
Please refer to IRB Submissions & Review Fees page under Study Deviation & Non-Compliance Report Form for more information.
Each event should be submitted using one Study 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 Study Deviation/Non-compliance Report Form.
Research data should be retained by the Principal Investigator in a secured storage facility. The documents should be accessible for inspection by authorised authorities.
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.
