Frequently Asked Questions. The CIRB is located at 168 Jalan Bukit Merah #06-08 Tower 3 Connection One Singapore

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1 1. Where is the location of the CIRB? The CIRB is located at 168 Jalan Bukit Merah #06-08 Tower 3 Connection One Singapore When is the submission deadline? The CIRB meets once a month. The submission deadline for the month s Full Board Review (for new studies, amendments, renewals and re-tabled cases) is the first working day of that same 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 studies reviewed under the expedited and exempted procedures, study applications or amendments (that involve minimal or less than minimal risks) may be submitted at any time. 3. How long is the ethics review process? Principal Investigators are advised to submit a complete application on time or in advance before the submission deadline (the first working day of the month). With the exception of the month of December, the time frame from submission to CIRB decision should, under normal circumstance, be within 30 calendar days of that monthly review cycle (which starts on the first working day of the month). However, 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. 4. Do I need to pay for my CIRB application? For studies which are initiated by industry or commercial entities, the following review fees will apply: - Initial IRB Application review involving Single Cluster institution(s) - S$1500,+ prevailing GST rate (i.e. S$1605) Initial Application review involving Cross Cluster institution(s) - S$2,500 + prevailing GST rate (i.e. S$2675) Subsequent Amendments - S$200 + prevailing GST rate (i.e. S$214) Subsequent addition of 1st Cross-cluster site: S$1,000 + prevailing GST rate (i.e. S$1,070) Page 1 of 7

2 5. What training qualification(s) should the Principal Investigator, Co- Investigator or Other Study Team Members submit? The minimum training requirement for SingHealth Study Team Members (e.g. Principal Investigators and Co-Investigators) 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: 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 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 that require a Clinical Trial Certificate/ Clinical Trial Authorisation/ Clinical Trial Notification from HSA, CIRB will not grant ethics approval for clinical trials applications until a receipt of proof for the Principal Investigator completion of the GCP course is provided. To attend the GCP workshop, you can register with any local institution which offers it, such as SingHealth Academy, National Healthcare Group (Classroombased or Online) and the online igcp course with National University of Singapore. 6. When is the study considered closed? The study is considered closed or completed if there is no more research activities, including contact with participant or any data analysis of identifiable data after which the investigator has to provide the study status report for closure to CIRB. 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 7. What should I submit for Protocol amendment and other documents e.g. Participant Information Sheet and Consent Form? Hardcopy Submission: The Principal Investigator must submit a cover letter with "track changed" version, a clean version of the revised document and include a summary of changes. Please submit one set of documents to 168 Jalan Bukit Merah #06-08 Tower 3 Connection One Singapore Page 2 of 7

3 ishare Approved studies: Please submit an amendment on ishare and make the necessary changes on the CIRB Amendment Form. 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 with the clean and track changed version of the revised document, together with a summary of change. 8. How do I make changes to the study team members? Hardcopy Submission: The PI should submit the Changes to Study Team Members Form to CIRB for review. Changes should be made on a per study basis (i.e 1 Form for 1 study). For inclusion or changes to PI or site PI, please submit together with the duly signed PI s declaration, Department Representative s Endorsement and Institution Representative s Endorsement Page. For addition of PI or site PI, please submit CV and CITI (Biomedical Research Investigators and Key Personnel Module). For clinical trials, the PI s GCP certificate is also required. For addition of Co-Is and Study Team Members, please submit their CV and CITI (Biomedical Research Investigators and Key Personnel Module). ishare Approved studies: Please submit an amendment and make changes under section B2 of the CIRB application form. 9. Who should be listed as study team members? 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. This applies to studies approved through hardcopy submission and ishare submission. Co-investigators - Members of the research/ clinical trial team designated by the Principal Investigator to perform study-related procedure and/or make important research-related decisions. Study Team Members - Personnel responsible for the design, conduct or reporting of the research. Page 3 of 7

4 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. Coinvestigators and Study Team Members). If an individual s role on 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, such individuals need not be listed as Co-investigators or Study Team Member. *The PI and/or site PI should determine if the study personnel meets the definition of study team members (Co-investigators and Study Team Members). 10. Is there a change in the renewal policy? I noticed that the valid till date is now exactly one year from the approval letter date. It no longer follows the initial valid till date. With the mutual recognition between CIRB and DSRB, we have changed and realigned some of our policies. As of Nov 2014, the renewal policy has been revised to: For study approved by the Full Board Review, the study is approved for a period of one year from the date that the study is reviewed and approved at the meeting. For study reviewed by the Expedited procedure, the approval is for a period of one year from the date the proposal is reviewed by the Chairperson or designee. 11. When should the site start submitting non-local* serious adverse events (SAEs)? The Principal Investigator should start submitting non-local SAEs from the point the study is submitted to CIRB. The safety information should cover the period of time from the last Investigator s Brochure update. It can be submitted as individual CIOMS format or in a summarized version (e.g. line listings or periodic reports). 12. When should the site cease to submit non-local* SAEs? The Principal Investigator may cease to submission of non-local SAEs after the CIRB has been informed of study closure. Page 4 of 7

5 13. What are the CIRB requirements for non-local* SAE reporting of investigational drugs used in clinical trials? For locally-registered drugs, expedited safety reports (i.e. serious, unexpected and related) arising from on-going trials in Singapore site(s) should be reported to CIRB. For locally-unregistered products, expedited safety reports (i.e. serious, unexpected and related) arising from all studies conducted worldwide using the same primary compound should be reported to CIRB. * Non-local SAEs include SAEs from sites not reviewed by CIRB. 14. Do I need to submit advertising/ recruitment materials for CIRB review and approval? When direct advertising (includes, but not limited to newspaper, websites, bulletin boards, posters, flyers, brochures, messages, 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 15. Does case report require CIRB review? 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. Page 5 of 7

6 The SingHealth Participant information Sheet and Informed Consent Form Template should not be use as the Informed Consent Document for case report studies. 16. How to determine if a Witness or an Impartial Witness is required during the Informed Consent Process? The following table summarizes when a witness or an impartial witness is required during an informed consent process: Clinical Trials regulated by HSA Human Biomedical Research under HBRA Requirement for Witness during informed consent discussion Participant or Participant or Participant s Legal Participant s Legal Representative is Representative is unable to read and/or able to read and/or sign on consent form sign on consent form Impartial Witness* Impartial Witness* Not Required Witness** *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 study **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 Page 6 of 7

7 Minimum Training Requirements for Staff from SingHealth and Partner Institutions Study Roles PIs and Site PIs conducting clinical trials PIs and Site PIs conducting non- clinical trials Everyone else in Study Team (Co-Investigators and Study Team Members) Training GCP and CITI (Biomedical Research Module - Refer to list below) CITI (Biomedical Research Module - Refer to list below) CITI (Biomedical Research Module) Modules include: 1. Belmont Report and CITI Course Introduction 2. History and Ethics of Human Research 3. Informed Consent 4. Social and Behavioral Research (SBR) for Biomedical Researchers 5. Records-Based Research 6. Genetic Research in Human Populations 7. Populations in Research Requiring Additional Considerations and/or Protections 8. Vulnerable Subjects - Research Involving Prisoners 9. Vulnerable Subjects - Research Involving Children 10. Vulnerable Subjects - Research Involving Pregnant Women, Human Fetuses, and Neonates 11. Conflicts of Interest in Research Involving Human Subjects Page 7 of 7