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:  Do I need ethics approval for secondary research? 
A5:  What if my research is conducted overseas?
A6:  Insurance cover for research participants
A7:  The journal/publisher is asking for evidence of ethics approval. How to obtain this? 
A8:  The journal/publisher requires my study to be registered in a trial registry. How to obtain this? 

Application-related

A8:  Minimum Training Requirements
A9:  PI eligibility on IRB applications
A10:  Students conducting human subjects research
A11:  Cross-recognition with NHG DSRB
A12:  Concept of "Minimal risk" and review categories
A13:  Exempt review
        A13i:  Exempt Category 1 - Research in established educational settings
        A13ii:  Exempt Category 2 - Educational tests, surveys, interviews, public observations
        A13iii:  Exempt Category 3 - Benign behavioural interventions
        A13iv:  Exempt Category 4 - Secondary research of existing datasets or biological materials
        A13v:  Exempt Category 5 - Research conducted or supported by government
        A13vi:  Exempt Category 6 - Taste and food quality evaluations
A14:  Expedited review
A15:  Full Board review
A16:  Do I need IRB approval for established commercial cell lines?
A17:  Should I submit an Amendment or a New Application? 

Recruitment methods

B1:  Advertisements/ Notices for recruitment of research participants
B2:  Payments for Reimbursement, Compensation & Incentives 
B3:  Recruitment of research participants by External Institutions
B4:  Eligibility screening & Recruitment numbers
B5:  Special considerations: Involving students as research participants
B6:  Special considerations: Use of deception or incomplete disclosure

Informed consent procedure

B7:  Consent requirement for research involving Minors
B8:  Assent guidelines for minors
B9:  Consent requirements for research involving deceased or mentally-incapacitated participants 
B10:  What is considered "Appropriate Consent" under HBRA?
B11:  Additional consent requirements for tissue banking under HBRA
B12:  Requirements of Witness for consent taking
B13:  Waivers of informed consent procedure
B14:  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. 

B15:  What is considered personal data/ individually-identifiable data/ identifiers?
B16:  Prohibition against collection of NRIC numbers
B17:  Use of camera or CCTV images/videos (including camera or CCTV installation)
B18:  How should researchers handle and store personal data?
B19:  Ways to anonymise or de-identify personal data 
B20:  Disclosure or sharing of identifiable data
B21:  No re-identification of anonymised information or biological material without consent
B22:  Should I upload identifiable data into data-repositories (e.g. DR-NTU (Data))?
B23:  What should I do if there is a data breach (i.e. data lost, leaked, inappropriately shared, etc.)? 

Miscellaneous

B24:  Section 424 of the Criminal Procedure Code (CPC424) 
B25:  Resources to support distressed participants

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

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

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