NTU-IRB Guidelines

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?

Application-related guidelines

A5: Minimum Training Requirements
A6: Cross-recognition with NHG DSRB
A7: Concept of "Minimal risk" and review categories
A8: Exempt review
        A8i: Exempt Category 1 - Research in established educational settings
        A8ii: Exempt Category 2 - Educational tests, surveys, interviews, public observations
        A8iii: Exempt Category 3 - Benign behavioural interventions
        A8iv: Exempt Category 4 - Secondary research of existing datasets or biological materials
        A8v: Exempt Category 5 - Research conducted or supported by government
        A8vi: Exempt Category 6 - Taste and food quality evaluations
A9: Expedited review
A10: Full Board review
A11: Do I need IRB approval for established commercial cell lines? 

Proper Conduct of Research

Recruitment methods

B1: Advertisements/ Notices for recruitment of research participants
B2: Special considerations: Involving students as research participants

Informed consent procedure

B3: Consent requirement for research involving Minors
B4: 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 HBRA
B7: Requirements of Witness for consent taking
B8: 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. 

B8: What is considered personal data/ individually-identifiable data/ identifiers?
B9: Prohibition against collection of NRIC numbers
B10: How should researchers handle and store personal data?
B11: Ways to anonymise or de-identify personal data.
B12: Should I upload identifiable data into data-repositories (e.g. DR-NTU)?


B10: Recruitment of research participants by External Institutions

Post-approval reviews and reporting

C1: Incident Reporting
C2: Incidental Findings (IFs)
C3: Continuing Reviews (CR) /Study Completion Review 

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

Human Tissue Framework (HTF) Guidelines

Singapore's Human Biomedical Research Act (HBRA) includes provisions ‚Äčto 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 tissues
E4: Handling of existing human tissues (collected prior to 1 Nov 2019)
E5: Importing/ transfer-in of human biological materials for research
E6: Exporting/ transfer-out/ withdrawal of human biological materials for research
E7: Collecting, storing and handling of human tissues