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 Requirements
A7: Cross-recognition with NHG DSRB
A8: Concept of "Minimal risk" and review categories
A9: 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 evaluations
A10: Expedited review
A11: Full Board review
A12: Do I need IRB approval for established commercial cell lines?
Proper Conduct of Research
B1: Advertisements/ Notices for recruitment of research participants
B2: Special considerations: Involving students as research participants
B3: Special considerations: Use of deception or incomplete disclosure
B4: Recruitment of research participants by External Institutions
Informed consent procedure
B5: Consent requirement for research involving Minors
B6: Consent requirements for research involving deceased or mentally-incapacitated participants
B7: What is considered "Appropriate Consent" under HBRA?
B8: Additional consent requirements for tissue banking under HBRA
B9: Requirements of Witness for consent taking
B10: Waivers of informed consent procedure
B11: Suggestions for remote consent taking
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 handle personal data appropriately to protect against loss, unauthorised access and accidental disclosure of such confidential data.
B12: What is considered personal data/ individually-identifiable data/ identifiers?
B13: Prohibition against collection of NRIC numbers
B14: How should researchers handle and store personal data?
B15: Ways to anonymise or de-identify personal data
B16: Disclosure or sharing of identifiable data
B17: Should I upload identifiable data into data-repositories (e.g. DR-NTU (Data))?
reviews and reporting
C1: Incident Reporting (includes deviations, non-compliances, unanticipated problems, adverse events, etc.)
C2: 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 2018
D5: HBRA Exemption Flowchart
Human Tissue Framework (HTF) Guidelines
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: Handling of existing human tissues (collected prior to 1 Nov 2019)
E4: Procuring/ importing/ transfer-in of human biological materials for research
E5: Exporting/ transfer-out/ withdrawal of human biological materials for research
E6: Collecting, storing and handling of human tissues