Use of human tissue
Following are the guidelines for gaining ethics approval for the use of human tissue. See also Human research ethics
- Introduction to use of human tissue
- Application and approval process
- Responsibility for human tissue samples
- Ethical issues
Introduction to use of human tissue
If you are undertaking research or teaching activity which involved the use of any human tissue (including body fluids), or material derived from human tissue, you must obtain UniSA Human Research Ethics Committee (UniSA HREC) approval before undertaking the research. The UniSA HREC Guidelines for preparing ethics protocols - RTF and Word - must be followed.
You do not need to obtain human ethics approval from UniSA HREC if the material has been reduced to such an extent that it is identical to material available from a non-human source. However, you may need to obtain approval from the Institutional Biosafety Committee for this activity.
Application and approval process
If you or a colleague are collecting tissue from a human donor (deceased or alive)
You must complete the ethics application form - RTF and Word. All procedures are identical as per using human participants.
Please refer to Human research ethics for details as to how to complete your application, submission dates, feedback and other useful information.
If you are using a human tissue sample previously collected for another purpose
You must:
- Complete the 'Ethics application' form - RTF and Word - and 'Use of human tissue samples in subsequent research' application form - RTF and Word.
- Submit 6 copies of your application to:
Ms Vicki Allen
Ethics and Compliance Officer
Research and Innovation Services
Mawson Lakes Campus
Tel (08) 8302 3921
Fax (08) 8302 3997
Email:
vicki.allen@unisa.edu.au
A subcommittee of UniSA HREC will consider applications for approval to use human tissue. Membership of this subcommittee will comprise:
- Chair of UniSA HREC
- Members filling the categories of:
- medical graduate
- lawyer
- layman or laywoman
- A member from outside UniSA HREC with expertise in human anatomical pathology.
The subcommittee will provide advice to UniSA HREC on the acceptance of the application and any conditions to be applied.
See also How to complete a human ethics application and UniSA HREC meeting and submission dates
Responsibility for human tissue samples
The organisation which obtains the human tissue material from the donor (called the originating organisation) is responsible for:
- gaining consent for the use of that material
- the material and its use.
The originating organisation may release human tissue material to researchers for subsequent projects (ie projects for which the material was not originally gathered). However, the research group receiving the material must seek ethics approval.
Please note: In cases where tissue is provided to the University of South Australia researcher by another organisation (such as a hospital), that tissue is provided for a particular purpose. Should the research change, or the researcher wish to use unused tissue for a new research project, agreement to the amended or new project should be sought from the originating organisation as well as UniSA HREC.
Ethical issues
The ethical issues surrounding the use of human tissue are similar to those that arise in relation to other research involving humans (see list below). These issues are addressed in the UniSA HREC ethics application form. They are also addressed in the 'Use of human tissue samples in subsequent research' application form - RTF and Word.
- Value of the research: Research involving humans should be demonstrably valuable.
- Safety of the researcher: Researchers will conform to the usual biological hazards provisions
- Consent: The organisation which obtains the original material is responsible for gaining consent for the use of that material. It is preferable if consent is also granted for further use of the material. Notwithstanding this, UniSA HREC would normally require proof of the donors consent if the proposed research involves foetal tissue or placenta, germ cells, propagation of genetic material or has the potential for commercial exploitation.
- Confidentialit y: Data and results would be stored in the same way as for other research involving human subjects. In most cases the researcher would be unable to identify individual donors, where individuals can be identified results should be coded in the same way as for other human research.