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Health Sciences Authority

Human Biomedical Research Act

Human Biomedical Research Act, notifications, serious adverse events, suspected offences or contraventions, declaration of compliance and TIARAS.

Last updated on 31 October 2026
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 Health Sciences Authority (HSA) 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 to HSA_HBR_Enquiries@hsa.gov.sg.

Links to decision tools

  1. Is my study Human Biomedical Research?  (opens in new tab)

  1. Am I handling human tissue and conducting tissue banking activities regulated under the Human Tissue Framework? (opens in new tab)

About the Act

  1. Human Biomedical Research Act 2015 (opens in new tab)

  2. Human Biomedical Research Regulations 2017 (opens in new tab)

  3. Human Biomedical Research (Restricted Research) Regulations 2017 (opens in new tab)

  4. Human Biomedical Research (Tissue Banking) Regulations 2019 (opens in new tab)

  5. Human Biomedical Research (Tissue Banking and Notification – Exemption) Regulations 2019 (opens in new tab)

  6. Human Biomedical Research (Requirements for Appropriate Consent – Exemption) Regulations 2019 (opens in new tab)

HBRA Guidance Documents

  1. Frequently Asked Questions (opens in new tab)

  2. Overview of Human Biomedical Research Framework (opens in new tab)

  3. Overview of Human Tissue Framework (updated July 2021) (opens in new tab)

  4. Table Differentiating Research from Research-like Activities (opens in new tab)

  5. Guidance on Prohibition against Commercial Trading of Human Tissue (opens in new tab)

  6. Guide on the Requirement of Appropriate Consent for the Conduct of HBR and Handling of Human Tissue (opens in new tab)

Circulars

  1. Guidance on Charging of Research Subject (opens in new tab)

List of HBRA Infographics

  1. HBRA SOC Infographics (opens in new tab)

  2. HBRA SAE Infographics (opens in new tab)

List of Research Institutions (RI) and Tissue Banks (TB) notified under HBRA

  1. Research Institutions notified under HBRA (opens in new tab)

  2. Tissue Banks notified under HBRA (opens in new tab)

Tissue and Research Application System (TIARAS) Guidance Documents

  1. A Guide to TIARAS (opens in new tab)

  2. TIARAS Screenshots for Notifications (Research Institution) (opens in new tab)

  3. TIARAS Screenshots for Declaration of Compliance and Updates to TIARAS (Research Institution) (opens in new tab)

  4. TIARAS Screenshots for Notifications (Tissue Bank) (opens in new tab)

  5. TIARAS Screenshots for Declaration of Compliance and Updates to TIARAS (Tissue Bank) (opens in new tab)