Guidelines

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:  Section 424 of the Criminal Procedure Code

Application-related guidelines

A7:  Minimum Training Requirements
A8:  PI eligibility on IRB applications
A9:  Students conducting human subjects research
A10:  Cross-recognition with NHG DSRB
A11:  Concept of "Minimal risk" and review categories
A12:  Exempt review
        A12i:  Exempt Category 1 - Research in established educational settings
        A12ii:  Exempt Category 2 - Educational tests, surveys, interviews, public observations
        A12iii:  Exempt Category 3 - Benign behavioural interventions
        A12iv:  Exempt Category 4 - Secondary research of existing datasets or biological materials
        A12v:  Exempt Category 5 - Research conducted or supported by government
        A12vi:  Exempt Category 6 - Taste and food quality evaluations
A13:  Expedited review
A14:  Full Board review
A15:  Do I need IRB approval for established commercial cell lines? 

B. PROPER CONDUCT OF RESEARCH

Recruitment methods

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
B5:  Payments for Reimbursement, Compensation & Incentives 

Informed consent procedure

B6:  Consent requirement for research involving Minors
B7:  Assent guidelines for minors
B8:  Consent requirements for research involving deceased or mentally-incapacitated participants 
B9:  What is considered "Appropriate Consent" under HBRA?
B10:  Additional consent requirements for tissue banking under HBRA
B11:  Requirements of Witness for consent taking
B12:  Waivers of informed consent procedure
B13:  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. 

B14:  What is considered personal data/ individually-identifiable data/ identifiers?
B15:  Prohibition against collection of NRIC numbers
B16:  Use of camera or CCTV images/videos (including camera or CCTV installation)
B17:  How should researchers handle and store personal data?
B18:  Ways to anonymise or de-identify personal data 
B19:  Disclosure or sharing of identifiable data
B20: No re-identification of anonymised information or biological material without consent
B21: Should I upload identifiable data into data-repositories (e.g. DR-NTU (Data))?
B22: What should I do if there is a data breach (i.e. data lost, leaked, inappropriately shared, etc.)? 

Miscellaneous

B23: 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