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
Newsletter No. 16 (Nov 2021)- Subject recruitment issues- Safety reporting- Updates from HSA and Requirements of CIRB Application/Amendment Form Sections F10 and H4
Newsletter No. 15 (Aug 2021)- FAQs on Tissue Banking- Updated CIRB Protocol Templates for Research Study and Clinical Trials
Newsletter No. 14 (May 2021)- FAQs on Informed Consent Process- How to check the CIRB application status in iSHaRe- Research Case Studies
Newsletter No. 13 (Feb 2021)- Healthy Volunteers in Clinical Research- Local GCP certificate for CIRB applications- FAQs on HBRA Human Tissue Framework
Newsletter No. 12 (Nov 2020)- FAQ for Human Tissue Banking Activities (updated)
Newsletter No. 11 (Sep 2020)- Screening and Enrollment- Remote Consent- HBRA Updates on Human Tissue Framework
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HBRA eLearning and definition of Interventional, Re-identification, SOCs, SAEs, Tissue Banking- Case study on use of superseded consent form
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
Newsletter No. 8 (Jun 2019)- Guidance on requirements of Appropriate Consent, FAQs- MOH Audit- National Electronic Health Records
Newsletter No. 7 (Apr 2019)- SingHealth Data Governance and Data Security- In event of any Data Breach- Human Biomedical Research Updates and FAQs
Newsletter No. 6 (Dec 2018)- Legacy Tissues and Declaration of Compliance Form- PI Self-Assessment Checklist Form- Obtaining Informed Consent after 1 Nov 2018
Newsletter No. 5 (Nov 2018)- Human Biomedical Research (Exemption) Regulations 2018- Decision Tree for Consent requirements- FAQs on Exemption Regulations
Newsletter No. 4 (Oct 2018)- HTF Framework, Consent for Existing HBR- De-identification Process- FAQ on Consent and Tissue Collection
Newsletter No. 3 (Apr 2018)- Regulation of Human Tissues- Legacy Tissue/Tissue Bank- De-identification, Research Tissue Bank, Informed Consent FAQs
Newsletter No. 2 (Feb 2018)- HBRA Updates- Health Information, Tissue FAQs - ICH GCP E6(R2)
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
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 [email protected]
Illuminaté: Issue 9 (Jul 2022)- Minimizing Risk
Illuminaté: Issue 7 (Jan 2022)- Alterations of Informed Consent Requirements
Illuminaté: Issue 6 (Jul 2021)- Informed Consent Requirements