OVERVIEW OF CONDUCT OF HUMAN SUBJECT AND HUMAN BIOMEDICAL RESEARCH



The Human Biomedical Research Act provides a legal framework for the conduct of human biomedical research (HBR) and the use of human tissue in research.

This guide has been compiled by the ODPRT Research Compliance and Integrity Office to provide you with information related to the HBRA, and resources specific to conducting human biomedical research at the National University of Singapore.

TransparentItem5_HBR

Planning your research - understanding HBRA


Before starting a study involving human subjects, data or biological material ensure you have the following:

  • Institutional, and where applicable, regulatory approvals
  • Ethics approval or exemption from ethics review
  • Special considerations taken into account for research involving human eggs, human embryos and human-animal cell combination

 

TransparentItem8_HBR

Planning your research - ethics review and protocol approval


All research involving human subjects, data or biological materials requires ethics approval or exemption from ethics review by an institutional review board (IRB) before commencement of the study.

Conducting any research work involving human subjects, data or biological materials without ethics approval or determination of exemption is an act of research misconduct under the NUS Code & Procedures in research integrity (clause 5(e)).

The University’s IRB is the NUS IRB. If you are unclear as to whether your proposed work requires ethics review, you should consult NUS IRB. 

TransparentItem7_HBR

Special considerations for human-animal combination research


If your study involves human eggs, human embryos or human-animal combinations, it is regulated as a prohibited or restricted human biomedical research under the HBRA.  

TransparentItem4_HBR


Things to take care of during the study


During your study you must ensure HBRA compliant consents have been taken from the research subjects or tissue donors and ensure that you protect the confidentiality of your subjects’ personal data.

Serious Adverse Events and Contraventions (or suspected contraventions) must be reported to your Reviewing IRB. 

Comply with all conditions of the letter of approval for your study issued by your Reviewing IRB, including submission of study status reports.

 

TransparentItem6_HBR

Considerations for the continuation / completion of your study


The principal investigator (PI) of a study is responsible for the submission of study status and completion reports in accordance with the requirements of the reviewing IRB.

It is the responsibility of the principal investigator to ensure that their research team members understand and comply with the rules of conduct for research involving human subjects, data or biological material. 


Have questions?

If you have any questions regarding how to ensure your research is conducted in compliance with the HBRA and NUS protocols, please contact rcio@nus.edu.sg.