7. Regulation of human biomedical research

What is the Human Biomedical Research Act (HBRA)?

The Human Biomedical Research Act (HBRA) was enacted in 2015 to provide clarity on the roles and responsibilities of individuals and body corporates involved in human biomedical research and the handling of human tissue for use in research, in order to ensure that the health, welfare, and safety of research participants remain a paramount consideration at all times.

Through the legislation, the Ministry of Health (MOH) strives to ensure that human biomedical research and tissue banking activities carried out in Singapore follow the law and principles of good clinical practice relating to ethics and science to protect the safety and welfare of research subjects and tissue donors.

If you have any questions or concerns about your compliance with the HBRA, please write in to MOH at the following email address hbr_enquiries@moh.gov.sg.

Links to decision tools

1. Is my study Human Biomedical Research?

2. Am I handling human tissue and conducting tissue banking activities regulated under the Human Tissue Framework?

3. Continuing Human Biomedical Research Beyond 1 November 2019

About the Act

1. Human Biomedical Research Act 2015

2. Human Biomedical Research Regulations 2017

3. Human Biomedical Research (Restricted Research) Regulations 2017

4. Human Biomedical Research (Tissue Banking) Regulations 2019

5. Human Biomedical Research (Tissue Banking and Notification – Exemption) Regulations 2019

6. Human Biomedical Research (Requirements for Appropriate Consent – Exemption) Regulations 2019

HBRA guidance documents

Infographics

List of Research Institutions (RI) and Tissue Banks (TB) notified to MOH

Tissue and Research Application System (TIARAS) guidance documents