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A1: Do I need to apply for IRB approval for my research? A2: What is not considered to be under IRB's purview? A3: What is considered "human subject" for IRB review purposes? A4: What if my research is conducted overseas?A5: Insurance cover for research participants
A6: Minimum Training RequirementsA7: Cross-recognition with NHG DSRBA8: Concept of "Minimal risk" and review categoriesA9: Exempt review A9i: Exempt Category 1 - Research in established educational settings A9ii: Exempt Category 2 - Educational tests, surveys, interviews, public observations A9iii: Exempt Category 3 - Benign behavioural interventions A9iv: Exempt Category 4 - Secondary research of existing datasets or biological materials A9v: Exempt Category 5 - Research conducted or supported by government A9vi: Exempt Category 6 - Taste and food quality evaluationsA10: Expedited reviewA11: Full Board reviewA12: Do I need IRB approval for established commercial cell lines?
B1: Advertisements/ Notices for recruitment of research participantsB2: Special considerations: Involving students as research participants
Informed consent procedure
B3: Consent requirement for research involving MinorsB4: Consent requirements for research involving deceased or mentally-incapacitated participants B5: What is considered "Appropriate Consent" under HBRA?B6: Additional consent requirements for tissue banking under HBRAB7: Requirements of Witness for consent takingB8: Waivers of informed consent procedure
Handling of personal data (or individually-identifiable data) The use of a subject's personal data (or individually-identifiable data) for research is regulated in Singapore under the Personal Data Protection Act (PDPA) and the Human Biomedical Research Act (HBRA). Researchers need to ensure that they protect and handle personal data appropriately.
B9: What is considered personal data/ individually-identifiable data/ identifiers?B10: Prohibition against collection of NRIC numbersB11: How should researchers handle and store personal data?B12: Ways to anonymise or de-identify personal data B13: Should I upload identifiable data into data-repositories (e.g. DR-NTU)?
B14: Recruitment of research participants by External Institutions
C1: Incident ReportingC2: Incidental Findings (IFs)C3: Continuing Reviews (CR) /Study Completion Review
Singapore's Human Biomedical Research Act (HBRA) regulates human biomedical research and the handling of human tissues for use in research. This is to protect the safety and welfare of research subjects, ensuring that their health and well-being is not compromised, and their privacy and autonomy is respected.
D1: Does your research fall within the scope of HBRA?D2: Prohibited and Restricted human biomedical research (rHBR) D3: HBRA contraventions concerning researchers D4: HBRA Exemption Regulations 2018D5: HBRA Exemption Flowchart
Singapore's Human Biomedical Research Act (HBRA) includes provisions to regulate tissue banks and tissue banking activities for research. It also prohibits the commercial trading of human tissue (whether for research, therapy or any other purpose).
E1: What is considered human tissue under HBRA?E2: What are considered tissue banking activities? E3: Prohibition against trading of human tissuesE4: Handling of existing human tissues (collected prior to 1 Nov 2019)E5: Importing/ transfer-in of human biological materials for researchE6: Exporting/ transfer-out/ withdrawal of human biological materials for researchE7: Collecting, storing and handling of human tissues
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