Policy and Procedures
NTU's policy on Research Involving Human Subjects is applicable to all NTU staff
and students directly or indirectly engaged in the design, conduct, supervision and reporting of research involving humans. It aims to achieve the highest ethical standards in all research activity involving human subjects, and to ensure that they
are adequately protected according to the core principles of rights, welfare, safety, privacy and confidentiality of human research subjects.
This policy covers research in both the Social, Behavioural and Educational Research (SBER) and Human Biomedical Research (HBR).
Researchers in NTU are also to ensure that your research activity is compliant with applicable legislation in Singapore, including but not limited to:
- the Personal Data Protection Act (PDPA) - Personal information
and human biological material collected for research should be kept confidential and stored in a secure environment with restricted access. Individually-identifiable information should not be shared with any third party without getting appropriate
consent from the human subject.
- the Human Biomedical Research Act (HBRA) - Studies within the scope of HBRA needs to ensure that your research activity are compliant with the additional safeguards required relating to the informed consent procedures, confidentiality of subjects, and the handling of human biological materials.
Please refer to our Guidelines page for more detailed information.
1. Overview of IRB Procedures
The table below shows an overview of the procedures under NTU's policy framework on research involving human subjects.
| 1. IRB Application & Review | 2. Study Conduct & Reporting | 3. Post-Approval Processes |
Minimum Training Requirements | Informed Consent Procedure Getting appropriate consent from your participants | Study Amendments Protocol amendments should be submitted for approval prior to changes in study conduct. This includes projects approved under the Exempt category. |
| IRB Application Obtain IRB approval prior to commencing any research activity | Handling and Protecting your Research Data To secure confidential data in compliance with PDPA and HBRA | Continuing Reviews Annual status reporting of your approved protocol for Expedited and Full Board studies |
| IRB Reviews Select for review under either Exempt, Expedited or Full Board reviews | Incident Reporting Reporting of protocol deviations, serious adverse events, and unanticipated problems. | Study Completions To report completion of studies for closure on system |
| Conflict of Interest Declare any COI | Reporting of Ethical Concerns Ethical concerns reported to RIEO will be handled in strict confidence. | Compliance Monitoring Proactive monitoring of selected high-risk studies by NTU-IRB |
2. Overview on Application Process
Applications of IRB approval must be submitted via NORA, and obtain endorsement by your AcR (or equivalent). IRB Admin will perform a preliminary check for completeness before being sent for review by an IRB Member.
Please refer to our Submission Procedure page for further details.
3. Overview on Review Categories
