Newsletters | SingHealth Duke-NUS

We aim to keep the research community with up-to-date information/news on research regulations, compliance, ethics and SingHealth policies and procedures through the newsletters. Best practice and frequently asked questions would be addressed too. We hope you will find the newsletters useful in your research journey. 　

RICE Newsletter

The newsletter communicates updates on important laws, regulations, guidance and SingHealth policies and procedures. Please note that the following are only accessible via SingHealth intranet. For ideas/suggestions on future topics, please contact oric@singhealth.com.sg

Issue	Link
Newsletter No. 30 (May 2025) - Recruitment of Cognitively Impaired Participants - ICH-GCP E6 (R3) for Clinical Trials -Sponsor Responsibilities in Investigator Initiated Trials (IIT)	Download
Newsletter No. 29 (Feb 2025) - Guide to Determine if your Project requires IRB Submission - Restricted Human Biomedical Research Policy Updates - CIRB Reporting Timelines for SAEs	Download
Newsletter No. 28 (Nov 2024) - Recruitment of Participants from Vulnerable Populations - New e-learning courses - Annual Declaration of Compliance for HBRA studies	Download
Newsletter No. 27 (Aug 2024) - Auxiliary Products in Research - ECOS FAQs	Download
Newsletter No. 26 (May 2024) - The Role of Translator and Witness in Informed Consent	Download
Newsletter No. 25 (Feb 2024) - Use of Clinical Human Tissue for Research & FAQs - e-learning platform - Blackboard	Download
Newsletter No. 24 (Nov 2023) - Preparation for Migration from iSHaRe to ECOS (a) Cutoff dates for New IRB Applications and Other Forms (b) Minimum Training Requirements - Case Studies	Download
Newsletter No. 23 (Aug 2023) - Study Recruitment - Electronic Consent FAQ - e-Learning Certificate Download	Download
Newsletter No. 22 (May 2023) - Minimum Training Requirements for All Research Staff - Recommended Research e-learning courses - FAQ on Monitoring & Audit	Download
Newsletter No. 21 (Feb 2023) - Completing the CIRB Study Renewal Report Form - IRB submission for Investigational Medical Device studies. 3. Restricted use of NEHR	Download
Newsletter No. 20 (Nov 2022) - CIRB new application form submission workflow. - Highlight of recent issues related to research conduct on IRB approval and lost of storage device.	Download
Newsletter No. 19 (Aug 2022) - Obtaining assent for research - Updated CIRB guidelines on advertisements for recruitment of research participants - Tips on Participant Information Sheet and Consent Form customization	Download
Newsletter No. 18 (May 2022) - Use of Prototype medical device for research - Lapses in renewal of IRB approval - Tips on CIRB Amendment Form submission – Study Amendment Cover Note	Download
Newsletter No. 17 (Feb 2022) - Reminder to obtain written informed consent before performing any research procedures - Tips on avoiding protocol deviations/non-compliances - Updates to Human Tissue Framework	Download
Newsletter No. 16 (Nov 2021) - Subject recruitment issues - Safety reporting - Updates from HSA and Requirements of CIRB Application/Amendment Form Sections F10 and H4	Download
Newsletter No. 15 (Aug 2021) - FAQs on Tissue Banking - Updated CIRB Protocol Templates for Research Study and Clinical Trials	Download
Newsletter No. 14 (May 2021) - FAQs on Informed Consent Process - How to check the CIRB application status in iSHaRe - Research Case Studies	Download
Newsletter No. 13 (Feb 2021) - Healthy Volunteers in Clinical Research - Local GCP certificate for CIRB applications - FAQs on HBRA Human Tissue Framework	Download
Newsletter No. 12 (Nov 2020) - FAQ for Human Tissue Banking Activities (updated)	Download
Newsletter No. 11 (Sep 2020) - Screening and Enrollment - Remote Consent - HBRA Updates on Human Tissue Framework	Download
Newsletter No. 10 (Apr 2020) - Research Advisories during COVID-19 - HBRA eLearning and definition of Interventional, Re-identification, SOCs, SAEs, Tissue Banking - Case study on use of superseded consent form	Download
Newsletter No. 9 (Oct 2019) - Activation of Human Tissue Framework on 1 Nov 2019 - Human Biomedical Research Regulations 2019 - Reminder to obtain re-consent & FAQs	Download
Newsletter No. 8 (Jun 2019) - Guidance on requirements of Appropriate Consent, FAQs - MOH Audit - National Electronic Health Records	Download
Newsletter No. 7 (Apr 2019) - SingHealth Data Governance and Data Security - In event of any Data Breach - Human Biomedical Research Updates and FAQs	Download
Newsletter No. 6 (Dec 2018) - Legacy Tissues and Declaration of Compliance Form - PI Self-Assessment Checklist Form - Obtaining Informed Consent after 1 Nov 2018	Download
Newsletter No. 5 (Nov 2018) - Human Biomedical Research (Exemption) Regulations 2018 - Decision Tree for Consent requirements - FAQs on Exemption Regulations	Download
Newsletter No. 4 (Oct 2018) - HTF Framework, Consent for Existing HBR - De-identification Process - FAQ on Consent and Tissue Collection	Download
Newsletter No. 3 (Apr 2018) - Regulation of Human Tissues - Legacy Tissue/Tissue Bank - De-identification, Research Tissue Bank, Informed Consent FAQs	Download
Newsletter No. 2 (Feb 2018) - HBRA Updates - Health Information, Tissue FAQs - ICH GCP E6(R2)	Download
Newsletter No. 1 (Dec 2017) - HBRA timelines and scope. Research, Studies and Matters excluded from "Human Biomedical Research" - Decision Tree for Types of Research under HBRA and Consent requirements - FAQs on Consent	Download

CIRB Illuminaté

Illuminaté is a newsletter published for CIRB members. The adapted versions are published here for researchers, investigators and study coordinators. The newsletter covers topics specific to IRB and its processes. For ideas/suggestions on future topics, please contact irb@singhealth.com.sg

Issue	Link
Illuminaté: Issue 20 (Apr 2025) 1. Single IRB Review for Cross-Clusters Collaborative Research 2. Study Status Report Form	Download
Illuminaté: Issue 19 (Jan 2025) 1. Non-local SAE Reporting Requirements and Timeline 2. Statement of Confirmation by PI for Project Not Requiring Submission to CIRB	Download
Illuminaté: Issue 18 (Oct 2024) - IRB Application Form	Download
Illuminaté: Issue 17 (Jul 2024) - Medical Device	Download
Illuminaté: Issue 16 (Oct 2023) - Revised Exemption Categories	Download
Illuminaté: Issue 15 (Jan 2024) - Restricted and Prohibited Research	Download
Illuminaté: Issue 14 (Oct 2023) - Recruitment Strategy	Download
Illuminaté: Issue 13 (Jul 2023) - Research Involving De-identified Data	Download
Illuminaté: Issue 12 (Apr 2023) - Waiver of Documentation of Informed Consent	Download
Illuminaté: Issue 11 (Jan 2023) - Incidental Findings in Research	Download
Illuminaté: Issue 10 (Oct 2022) - Research involving Human Biological Materials - Changes to Assent requirements	Download
Illuminaté: Issue 9 (Jul 2022) - Minimizing Risk	Download
Illuminaté: Issue 8 (Apr 2022) - Who can be PI, PI’s Responsibility and Adaptive Designs for Clinical Trials.	Download
Illuminaté: Issue 7 (Jan 2022) - Alterations of Informed Consent Requirements	Download
Illuminaté: Issue 6 (Jul 2021) - Informed Consent Requirements	Download
Illuminaté: Issue 5 (Apr 2021) - Types of Review (Full Board, Expedited, Exemption, IRB Determination)	Download
Illuminaté: Issue 4 (Jan 2021) - Types of Submissions to IRB	Download
Illuminaté: Issue 3 (Nov 2020) - Training Resources and Who can be PI?	Download
Illuminaté: Issue 2 (Sep 2020) - Clinical Research/ Trial & Regulations	Download
Illuminaté: Issue 1 (Jul 2020) - Differentiate research from other projects	Download