Human Tissue in Research

Human tissue, or biospecimens, refer to any biological material obtained from a person including tissue, blood, urine and sputum; it also includes any derivative of these, such as cell lines. It does not include non-human biological material such as micro-organisms that live on or in a person.

Any research involving sites in NSW using human tissue should consider the requirements of the NSW Human Tissue Act (1983). The guidance outlined in Chapter 3.2 Human biospecimens in laboratory based research of the National Statement on Ethical Conduct in Human Research (National Statement) (2007) – updated 2018 and as updated should also be considered.

When reviewing research involving human tissue, Human Research Ethics Committees will review the application in accordance with both the law and the requirements set out in the National Statement. The requirements of the law override the provisions of the National Statement.

Human Tissue Act Guidance Document

NSW Health has developed a guidance document on the Requirements of the Human Tissue Act (1983) in relation to research & use of tissue (GL2023_008). The guidance takes into account amendments made to the Human Tissue Act (1983) in 2003, detailing the legal consent requirements in relation to tissue removed prior to and after 1 November 2003.

Transfer of SLHD patient tissue

If transferring Sydney Local Health District (SLHD) patient tissue outside of the SLHD, please refer to the ‘Material and Data Transfer Agreements’ section of our website:

RPAH: https://www.slhd.nsw.gov.au/rpa/research/mta.html

Consent requirements for use of tissue in research

Use the decision tree below for determining the consent requirements of the Human Tissue Act 1983 (NSW) in relation to research and use of tissue.