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Use of human tissue

Following are the guidelines for gaining ethics approval for the use of human tissue. See also Human research ethics

 

Responsibility for human tissue samples

The organisation which obtains the human tissue material from the donor (the originating organisation) is responsible for gaining consent for the use of that material.

The originating organisation is responsible for the material and its use. The organisation might release human tissue material to researchers for subsequent projects (ie projects for which the material was not originally gathered).

It should be noted that 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 from UniSA Human Research Ethics Committee (UniSA HREC).


Gaining ethics approval to use human tissue samples

The use in research of any human tissue, or material derived from human tissue, requires HREC approval. This will be the case for the original research project for which the tissue was obtained from a donor (through the submission of an ethics protocol proforma to the HREC of the relevant organisation/s), and for any subsequent research (through the submission of an application for approval to use human tissue samples for subsequent research to the HREC of the relevant organisation/s). The only exception would be when the material has been reduced to such an extent that it is identical to material available from a non-human source.

When a University of South Australia researcher plans to use human tissue or body fluids (referred to as human tissue) which is collected by them, or for them by a colleague, for a particular research project, the researcher should complete and submit an ethics protocol proforma (RTF file). The usual HREC guidelines for completing ethics protocol proformas (RTF file) should be followed. This is the case for current projects involving either live or deceased donors.

When a University of South Australia researcher plans to use human tissue previously collected for another purpose, the researcher should complete and submit a Use of human tissue samples in subsequent research application form.
 

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Ethical issues

The ethical issues that surround the use of human tissue are similar to those that arise in relation to other research involving humans including

These issues are addressed in the Human Research Ethics Committee ethics proforma. They are also addressed in the Use of human tissue samples in subsequent research application form in the following ways.

Value of the research
Research involving humans should be demonstrably valuable. Researchers should briefly outline their research hypothesis and research methodology on the application form.

Safety of the researcher
Researchers will conform to the usual biohazards 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, HREC would normally require proof of the donor’s consent if the proposed research involves foetal tissue or placenta, germ cells, propagation of genetic material or has the potential for commercial exploitation.

Confidentiality
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.
 

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Application process

Researchers seeking ethics approval to use human tissue collected by/for them must complete the ethics protocol proforma. Researchers seeking ethics approval to use human tissue originally collected for another purpose should, in addition to completing the ethics protocol proforma, also complete the Use of human tissue samples in subsequent research application form and submit 6 copies 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 the Human Research Ethics Committee will consider applications for approval to use human tissue. Membership of this subcommittee will comprise

Chair of UniSA HREC 
Members filling the categories of

A further member from outside UniSA HREC with expertise in human anatomical pathology will also be included. The subcommittee will provide advice to UniSA HREC on the acceptance of the application and any conditions to be applied.

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