Proposed guidelines on use of human tissue

Proposed guidelines on use of human tissue

Dr Sandy Dawson, Chief Clinical Advisor

The Ministry of Health has released proposed guidelines covering the use of human tissue for future unspecified research for public consultation.

Advances in technology have created new research opportunities using human tissue and the guidelines will provide researchers and ethics committees with a nationally consistent approach for considering research applications.They also specify the information and options individuals should have before they consent to donating tissue for future unspecified research.

For example, the proposed guidelines say it is acceptable, with suitable consent, to send samples overseas for use by research collaborations and for potential use by third parties.

"New Zealand already has clear guidelines on the ethical collection, use and disposal of tissues for research which is specified at the time that consent is given. These proposed guidelines provide additional guidance for ethics committees and researchers to cover situations where tissues can be stored and used for to find answers to research questions that arise in future,'' says Dr Dawson.

Human tissue is defined as any material that is, or includes human cells. It includes all or any part of a body, a foetus or the body of a still-born child; human stem cells, other human cells and blood.

At the moment New Zealand does not have specific guidelines covering the use of human tissue for future unspecified research. Research applications are submitted to a health and disability ethics committee and considered in accordance with general guidance set out in the Operational Standard for Ethics Committees.

But new research, particularly in areas such as cancer and genetic diseases, is often reliant on tissue collected for other clinical, diagnostic or research purposes. New collections of tissue for research, known as "bio-banks", are also being formed around the world.

In New Zealand the Human Brain Bank in Auckland uses donated brain tissue to conduct research on neuro-degenerative diseases while the Otago School of Dentistry is studying tissue samples to see if there is a link between oral cancer and the yeast that causes oral thrush.

New Zealand research groups are among those who wish to bank human tissue for future, unspecified research. In particular, researchers involved in international research want to send human tissue to study centres overseas.

The Ministry recently reviewed the regulatory framework for human tissue with a view to replacing the current Human Tissue Act 1964. New legislation is expected to be introduced and, if possible, passed this year. That legislation will cover the use of human tissue in research, what requires consent and who can give consent, along with issues around the safety, storage and disposal of tissue. The proposed ethical guidelines for future unspecified use of human tissue may need to be reviewed once the new legislation is in place to ensure consistency.

The Ministry of Health is seeking feedback on the proposed guidelines from interested groups and individuals from June through to August. Once finalised the guidelines are likely to form part of the Operational Standard for Ethics Committees.

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