Policy and Procedures

 

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:

  1. 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.

  2. 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. 


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 & Review2. Study Conduct & Reporting​3. Post-Approval Processes

​ Minimum Training Requirements
CITI certification

IRB Application
Obtain IRB approval prior to commencing any research activity

IRB Reviews
Select for review under either  Exempt,  Expedited or  Full Board reviews

Conflict of Interest
Declare any COI

 

​ Informed Consent Procedure
Getting appropriate consent from your participants

Handling and Protecting your Research Data
To secure confidential data in compliance with PDPA and HBRA

Incident Reporting
Reporting of protocol deviations, serious adverse events, and unanticipated problems.

Reporting of Ethical Concerns
Ethical concerns reported to RIEO will be handled in strict confidence. 		Study Amendments
Protocol amendments should be submitted for approval prior to changes in study conduct. This includes projects approved under the Exempt category.

Continuing Reviews
Annual status reporting of your approved protocol for Expedited and Full Board studies

Study Completions
To report completion of studies for closure on system

Compliance Monitoring
Proactive monitoring of selected high-risk studies by NTU-IRB
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. 

Overview on Review Categories

The category of review is based on the  level of risks anticipated in your research study. Please refer to the following examples for studies in each category:  Exempt,  Expedited,  Full Board.