NUS-logo-blue-1200 HBRA eTraining Materials

PLANNING YOUR RESEARCH - BEFORE THE STUDY STARTS

Human Tissue Regulatory Framework applies if tissues are involved

Human Biomedical Research Act
(HBRA)

Tissue collection, storage, use, supply or import requires appropriate consent and the activity must be conducted in accordance with any conditions specified as part of the consent (Sections 37 & 12(2), HBRA). Commercial trading of Tissues is prohibited (Sections 32 & 33 HBRA)

Human Biomedical Research (Tissue Banking) Regulations

Applies to persons and facilities which store/supply tissues for research and to studies approved as tissue-banking protocol studies where the researcher supplies tissues to other researchers (Section 2, HBRA definitions of “tissue-banking activity” and “tissue”)


Thus, HBRA has 2 Regulatory Frameworks, one or both of which could apply to your study/activity:

  1. Human Biomedical Research Regulatory Framework
  2. Human Tissue Regulatory Framework

Example: If your research involves use of individually-identifiable saliva samples, they would not be tissues and the Human Tissue Regulatory Framework does not apply. However,  the HBR Regulatory Framework governing research using individually-identifiable human biological materials, may still apply.

Please refer to MOH Decision Tools and Resources on the following:
1. Decision Tool on Human Biomedical Research Framework
2. Decision Tool on Human Tissue Framework: Am I handling human tissue (Part 1) and conducting tissue banking activities (Part 2)?
3. Overview of Human Tissue Framework: Am I a Tissue Bank? (see slide #6)



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