Human Ethics Resources
Research involving the use of human tissue and research with bio-safety implications should be designed with reference to the following policies that will assist you in obtaining ethics approval.
Human tissue policy
Objectives
The University of Western Australia’s objective under this policy is to ensure that the utilisation of human tissue samples, including organs, body fluids and genetic material, complies with relevant State and Commonwealth legislation, guidelines and codes.
Policy conditions
- Where a research project proposes acquisition, collection or analysis of human tissue samples, it must be approved by the Human Research Ethics Committee and not by a Regional Ethics Review Committee of the University.
- This ethics review and approval requirement applies to human tissue acquired specifically for research purposes, or acquired during the course of clinical diagnostic or therapeutic procedures and subsequently identified as being suitable for research purposes.
- It is the researcher’s responsibility to ensure that all required bio-safety approvals are identified and obtained prior to the commencement of research.
- Researchers must retain detailed records relating to research involving human tissue, including detailed information about:
- Source of the tissue,
- Nature of the consent obtained when the samples were collected,
- The facility and conditions where storage occurs
- Intended destruction of tissue samples,
- Time period for retention of records to comply with the type of research activity, and legislative and regulatory requirements.
- Where tissue collections are to be accessed (e.g. through a biobank) this process must adhere to the guidelines of the Office of Population Health Genomics (WA).
- Where tissue samples are to be transported for research at another site(s), the Human Research Ethics Committee (HREC) must be notified, through the Human Research Ethics Office (HREO).
- Transfer of human tissue samples to another site may occur where a UWA researcher acquires tissue intended for wider research use; or for transfer to other researchers; or where a UWA researcher transfers to another institution.
- Evidence of HREC ethics approval of the proposed research at the other site(s) must be included with the notification of transfer of tissue.
- Tissue samples should be transferred to another site(s) in accordance with a documented protocol for standards of collection and transport.
- The School, or Research Centre, where the tissue is to be used for research purposes must assume primary responsibility for the documentation of a protocol for collection and transport of the tissue.
- Documentation of the protocol for transfer of the human tissue must be included with the notification of transfer of tissue (this may be provided as an approved Standard Operating Procedure – SOP).
Note
The definition of ‘human tissue’ includes any human body organs, tissues, or fluids (e.g. skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens, fresh or paraffin-embedded) and tissue derivatives, including DNA, RNA, and proteins obtained from human beings.
Acknowledgment
The Human Research Ethics Office of the University of Western Australia acknowledges the advice and assistance provided by Murdoch University and the Ethics Office of the Peter MacCallum Cancer Institute in developing this ‘human tissue’ policy.
Office of Bio-Safety policies
Where your research will/may involve bio-safety considerations, you should be familiar with relevant policies of the Office of Bio-safety located at:
University information
CRICOS Code: 00126G
