A. GENERAL GUIDELINES
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: PI eligibility on IRB applications
A8: Students conducting human subjects research
A9: Cross-recognition with NHG DSRB
A10: Concept of "Minimal risk" and review categories
A11: Exempt review
A11i: Exempt Category 1 - Research in established educational settings
A11ii: Exempt Category 2 - Educational tests, surveys, interviews, public observations
A11iii: Exempt Category 3 - Benign behavioural interventions
A11iv: Exempt Category 4 - Secondary research of existing datasets or biological materials
A11v: Exempt Category 5 - Research conducted or supported by government
A11vi: Exempt Category 6 - Taste and food quality evaluations
A12: Expedited review
A13: Full Board review
A14: Do I need IRB approval for established commercial cell lines?
B. 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: Use of camera or CCTV images/videos (including camera or CCTV installation)
B15: How should researchers handle and store personal data?
B16: Ways to anonymise or de-identify personal data
B17: Disclosure or sharing of identifiable data
B18: No re-identification of anonymised information or biological material without consent
B19: Should I upload identifiable data into data-repositories (e.g. DR-NTU (Data))?
B20: What should I do if there is a data breach (i.e. data lost, leaked, inappropriately shared, etc.)?
B21: The journal/publisher requires my study to be registered in a trial registry. How to obtain this?
C. POST-APPROVAL REVIEWS AND REPORTING
C1: Amendments (to approved protocols, consent forms, recruitment numbers, etc.)
C2: Continuing Reviews (CR) /Study Completion Review
C3: Incident Reporting (includes deviations, non-compliances, unanticipated problems, adverse events, data loss, etc.)
C4: Incidental Findings (IFs)
C5: Compliance Monitoring
D. HBRA-RELATED GUIDELINES
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
E. 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: Collecting/ Procuring/ Importing/ Transfer-in of human biological materials for research
E5: Exporting/ Transfer-out/ Withdrawal of human biological materials for research
E6: Handling and Storage of human tissues