Non-therapeutic use of human tissue

19/10/2009

19 October 2009

Standards New Zealand recently published a new Standard, Non-therapeutic use of human tissue NZS 8135:2009. 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
  • Research
  • Education and training
  • Anatomical examination
  • Clinical audit
  • Supply of tissue for use in the manufacture of reagents or products for laboratory use

The Ministry of Health sponsored the development of NZS 8135:2009 following a review of the regulation of human tissue and tissue-based therapies. The Standard provides the Ministry of Health with the ability to monitor and regulate the processes for tissue collection and use, in accordance with the legislative requirements and agreed acceptable practice.

NZS 8135:2009:

  • 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.

The committee included representatives of the following nominating organisations: Auckland District Health Board; College of Nurses Aotearoa; Counties Manukau District Health Board (Bereavement Care Services); Department of Ophthalmology, University of Auckland; Department of Radiology with Anatomy, University of Auckland; Health Research Council of New Zealand; Lakes District Health Board; Ministry of Health, Strategic Policy on Ethics and Innovation; National Screening Unit, a separate unit of the Ministry of Health; New Zealand Organisation for Rare Disorders, New Zealand Police; Northern X Ethics Committee; Oncology Service, Christchurch Hospital; Otago District Health Board; and School of Biological Sciences, University of Canterbury.

Click here to order or download NZS 8135:2009, visit www.standards.co.nz (keyword '8135'), email enquiries@standards.co.nz, or call 0800 782 632.

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Shona Weller
Standards New Zealand
(04) 498 3986
shona.weller@standards.co.nz

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