Human Tissue Authority: Codes of Practice - Disposal Dr Kirstin Goldring Biobank Facilitator

Human Tissue Act 2004 HT Act implemented 1 st September 2006: –Regulates removal, storage and use of tissue and organs from the deceased, and the storage and use of tissue from the living HT Act: General Information Covers England, Wales and Northern Ireland. Separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 HT Act does not apply retrospectively Foetal tissue is treated as any other tissue under the Act, although embryos and gametes are excluded Consent is the overarching principle

Human Tissue Authority – Regulatory Authority HTA provides advice and guidance about two laws: the Human Tissue Act 2004, and the EU Tissue and Cells Directives - European laws that have been implemented in the UK via the Quality and Safety Regulations These laws ensure human tissue is used safely and ethically, with proper consent. HTA was set up to regulate removal, storage, use and disposal of human bodies, organs and tissue for a number of Scheduled Purposes HTA was established on 1 st April 2005 HTA - Regulation Regulatory aim To create an effective regulatory framework for the removal, retention, use and disposal of human tissue and organs in which the public and professionals have confidence. The HTA does not regulate the diagnosis or treatment of illnesses in living people, as this is not covered by the HT Act.

Licences for following sectors – Tissues and cells for human treatment Human application stem cells and cord blood transplants Post mortem services Research Anatomy Public Display HTA - Licensing

Codes of Practice - provide practical guidance and lay down expected standards for each of the sectors Code of practice 1 - Consent Code of practice 2 - Donation of solid organs for transplantation Code of practice 3 - Post-mortem examination Code of practice 4 - Anatomical examination Code of practice 5 - Disposal of human tissue Code of practice 6 - Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation Code of practice 7 - Public display Code of practice 8 - Import and export of human bodies, body parts and tissue Code of practice 9 – Research HTA - Licensing

Code of Practice – Disposal The HTA and disposal The remit of the HTA includes regulating disposal of human tissue (excluding gametes and embryos), including imported tissue, following its use for a scheduled purpose.

Code of Practice – Disposal DEFINITIONS RELEVANT MATERIAL: Material other than gametes, which consists of or includes human cells (does not include embryos). SCHEDULED PURPOSES: The activities relating to the removal, storage and use of human organs and other tissue that require consent, listed in Schedule 1 of the HT Act, e.g. research in connection with disorders or the functioning of the human body. RESIDUAL TISSUE: Material left over from a diagnostic or therapeutic intervention. SURPLUS TISSUE: Relevant material which has come from a body in the course of receiving treatment, diagnostic testing or participating in research.

Code of Practice – Disposal The HT Act makes it lawful to treat as ‘waste’ any relevant material which has come from a person who was: Participating in research, In the course of receiving medical treatment, or Undergoing diagnostic testing. And material that: Has been removed from a living human body, and Ceases to be used, or stored for use, for scheduled purposes This includes surplus material from tissue samples: tissue fragments from histology samples, tissue in the sections trimmed from a wax-embedded block before usable sections are cut, and unrecoverable bodily material washed out of the tissue during processing into a wax block. If the donor has since died: Surplus material from tissue samples from persons who have since died, should be disposed of with respect. As a minimum, this material should be disposed of separately from other clinical waste.

Code of Practice – Disposal POLICIES Processes should be in place to inform individuals, or their relatives, how tissue will be disposed of after use. Staff should be prepared to discuss the issue of disposal, explaining the options available and who will be responsible for any associated costs Attitudes towards disposal may vary widely among cultures and religions. Staff should be sensitive to this, whilst being aware that choices are for the individual or relative to make Establishments should ensure that their employees are given the necessary training and support to help them identify and meet the widest possible range of needs and wishes Establishments should ensure that they have systems in place to maintain proper records and documentation for all tissue they acquire or pass on to others. Records should include: when the material was acquired, and where from what has been consented to the uses to which the material is put whilst in the establishment’s care and any processes applied to it when the material is transferred elsewhere, and to whom the time, place, method of and reason for disposal

Disposal options are dependent on type of tissue and origin but include: Burial, incineration or cremation Cremation of human tissue is possible under The Cremation (England and Wales) Regulations 2008 [ providing that:tissuewww.opsi.gov.uk/si/si2008/uksi_ _en_1 the death of the person was duly registered; an application for the cremation of the tissue has been made by an appropriate person on the proper form; andtissue a certificate on release of body parts has been provided by the holder or, if not possible to provide such a certificate, other evidence that the body parts were removed in the course of a post-mortem examination. Code of Practice – Disposal Options

Code of Practice – Disposal Disposal Options for Existing holdings An existing holding is material (identifiable or unidentifiable) that was stored for a scheduled purpose when the HT Act came into force on 1 September 2006 Unidentifiable tissue Unidentifiable tissue may include blocks and slides, organs, skeletons and bonestissue Disposal can be by incineration or burial. Where samples are unidentifiable, it will not be possible to cremate the material due to the necessary accompanying documentation stipulated under The Cremation (England and Wales) Regulations 2008 Identifiable tissue Identifiable tissue may include blocks and slides, organs, skeletons and bones. Decisions about existing holdings that are identifiable should cover the following:tissue 1.for existing holdings that are identifiable and about which relatives are in contact 2.for existing holdings which are identifiable but are unclaimed Disposal can be by incineration or burial. An establishment wishing to bury identifiable tissue should consult the local burial authorities to establish what level of service they can provide.tissue In both cases If the existing holdings are not required, the establishment should ensure that records detailing the method and reason for disposal are maintained Unidentifiable and identifiable human tissue, like all tissue, should be treated with respect, without placing a disproportionate burden on staff or resources. Dignified treatment and separate disposal are the minimum considerations involved in disposing of stored tissue. This means disposal should be carried out separately from clinical waste, but not that each tissue sample necessarily needs to be disposed of individuallytissue

Code of Practice – Disposal Disposal Options for organs/tissue removed from a living person Material taken from the living should normally be disposed of by incineration in accordance with current guidelines on Safe Disposal of Clinical Waste (1999)4. Specific guidance has been provided on disposal of fetal tissue (later slide) Although guidance on fetal tissue does not apply to embryos created in vitro which have not been transferred into a woman; in this case disposal should be in accordance with the Human Fertilisation and Embryology Authority’s Code of Practice7. Requests by patients to retain tissue samples or arrange disposal themselves should be considered on a case-by case basis, taking account of any risk to the patient and others.

Code of Practice – Disposal Disposal of organs/tissues removed from a deceased person Tissue and organs should be handled in accordance with any reasonable wishes expressed by relatives or the deceased person, as long as the method of disposal is legal. The time, place and method of disposal should be recorded. Researchers should be familiar with local arrangements and options for disposal, and provide written information if requested. HTA’s role is to empower establishments to make decisions locally about the most suitable methods of disposal in each case. But there should be a clear policy available to the public Where practical, human tissue should be bagged separately from clinical waste, but disposed of within the same incinerator. It is not necessary for each tissue sample to be disposed of individuallytissue The code sets out the main disposal options; the chosen disposal method should reflect the type of tissue and the relatives’ wishes where possible, in order to ensure respectful disposal. Basic disposal options are incineration, cremation or burialtissue If practical, the hospital may offer to store the body until the organ or tissue can be returned to it. If the deceased person has been buried or cremated, relatives may ask for remaining tissues or organs to be returned later. Arrangements need to be lawful and safe.

Disposal of fetal tissue (up to 24 weeks gestation) Researchers should follow the relevant NHS organisation’s disposal policy for pregnancy loss before 24 weeks gestation. This policy should reflect the guidance in the HTA Code of Practice3 Appendix B, which is summarised below: Disposal options A woman or couple should be told that information on disposal options is available if they wish to see it, and it should be clearly documented in the women’s medical notes if information was requested and given. Any personal, religious or cultural needs should be met wherever possible and documented in medical notes. A woman or couple may wish to arrange disposal themselves and are free to do so. Burial Fetal tissue can be buried providing there has been consultation with the woman / couple. A woman or couple can bury fetal tissue at home if they wish, in consultation with local authorities Cremation Fetal tissue can be cremated providing there has been consultation with the woman / couple where appropriate. Incineration Fetal tissue from a pregnancy lost before 24 weeks may be incinerated although how appropriate this is depends on individual circumstances. Disposal by maceration / sluicing is not permitted. Incineration should be carried out in accordance with Department of Health guidance6. Code of Practice – Disposal

HTA guidelines for disposal of tissue used for research purposes 1. Develop a clear and sensitive policy for disposing of human body parts and tissues which is: documented, and complies with health & safety recommendations. (This may simply refer to a local NHS policy). 2. Carefully document the reasons for disposal and methods used, by: developing standard operating procedures for tracking the disposal of tissue, and ensuring disposal arrangements reflect (where applicable) the consent given for disposal.

Code of Practice – Disposal

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