The Human Tissue Act 2008 provides for regulations to prescribe or approve standards for the collection or use of human tissue for education, research or other non-therapeutic purposes (such as audit and anatomical examination).
Standards New Zealand has published a standard for non-therapeutic use of human tissue, Non-therapeutic use of human tissue NZS 8135:2009. It can be purchased from the Standards New Zealand website. (Search for 8135 under Name, Keyword or Number.)
The standard ensures that where a person, or their family/whānau, has given consent to the use of human tissue for non-therapeutic purposes (for example, research or education), correct processes are followed for collection, storage, use and return/disposal of tissue.
NZS 8135:2009 specifies the quality and safety requirements for the non-therapeutic use of human tissue, in support of the Human Tissue Act 2008. The standard aims to increase public confidence in tissue practices and addresses the need for clarity and consistency in processes for tissue collection.
NZS 8135:2009 provides clear guidance to users of human tissue on acceptable practice and applies to any organisation that collects, retains, stores, uses, or disposes of human tissue for any of the following purposes.
- Non-coronial post-mortem
- Education and training
- Anatomical examination
- Clinical audit
- Supply of tissue for use in the manufacture of reagents or products for laboratory use
- applies to human tissue collected from both living and deceased people before and after the enactment of the Human Tissue Act 2008
- does not apply to tissue obtained during a healthcare procedure, except where this tissue may subsequently be used for a non-therapeutic process (such as tissue removed during surgery that is donated and subsequently used in research or education)
- provides a safety framework under which an organisation can self-assess compliance with the Human Tissue Act 2008
- should be interpreted in a manner that is consistent with donor/family/whānau rights and providers' obligations under the Code of Health and Disability Services Consumers' Rights (the Code) and the requirements under the Human Tissue Act 2008.