Human Tissue Act DEBBY GIBSON HUMAN TISSUE ACT MANAGER LTHT AND UOL

Transcription

1 Human Tissue Act DEBBY GIBSON HUMAN TISSUE ACT MANAGER LTHT AND UOL

2 Introduction 1) Summary of the Human Tissue Act 2004 (HT Act) 2) The Human Tissue Authority (HTA) and how it regulates. Including: - What licences we have within LTHT / UoL - Governance - Codes of Practice - Relevant Material - Consent and Scheduled Purposes 3) Questions

3 The Human Tissue Act 2004 Some key points of the HT Act are: The HT Act is a legal framework for regulating the storage and use of human organs and tissue from the living, and the removal, storage and use of tissue and organs from the deceased, for specific health related purposes and public display The Act makes it an offence to have human tissue, which includes hair, nail and gametes in this context, with the intention of its DNA being analysed without the consent of the individual from whom the tissue came, or of those close to them if they have died. This provision applies UK-wide. Penalties for not obtaining consent are provided

4 When did it start? The HT Act came into force on 1 st September 2006 and covers England, Wales and Northern Ireland. There is separate legislation for Scotland Why was it implemented? Organ-retention scandals at Liverpool's Alder Hey Hospital, Bristol Royal Infirmary and the lesser publicised Isaac s Enquiry, brought issues of consent, and organ and tissue use and storage under the spotlight. Organ s and tissue from children had often been removed, stored and used without proper consent. Consent is the fundamental principle of the HT Act

5 The Human Tissue Authority (HTA) The Human Tissue Authority (HTA), is a regulatory body, established under the HT Act and is sponsored by the DoH. Their strategic aim is: To create a regulatory system for the removal, use and disposal of human tissue and organs that is clear, consistent and proportionate and in which professionals, patients, families and members of the public have confidence. Current status of HTA following DoHs Arm s length body review - Retain as separate ALB until Work with DoH, assess the practicalities and legal implications of transferring HTA functions between a new research regulator, the Care Quality Commission and Health and Social Care Information Centre

6 How is it implemented? The HTA have three principle statutory functions: Issue Codes of Practice Issue Licences and Inspect establishments Approve solid organ and bone marrow donations from living donors They regulate activities concerning the removal, storage, use and disposal of human tissue referred in the HT Act as relevant material These regulated activities are referred to as scheduled purposes

7 HTA Regulation The HTA regulate over six broad sectors (The first five relate to licences awarded to establishments): Tissue for human application (human treatment) Research Post Mortem Anatomy Public Display Living Donor Transplants (approval of)

8 What we have in Leeds To comply with the HT Act, the LTHT and UoL chose to work collaboratively, where possible, and between them hold four of the five HTA licences: Anatomy covering specific premises at UoL for anatomical examination Research Therapeutic Use Pathology covering specific premises at LTHT and UoL (mainly faculty of Medicine and Health but not exhaustive) covering specific premises at LTHT covering specific premises at LTHT Non-compliance with the HT Act, including the terms of the above licences, can be a serious disciplinary matter and may incur personal criminal liability.

9 Governance requirements for each licence: Designated Individual (DI) The person under whose supervision the licensed activity is conducted Licence Holder (LH) Must have the consent of the DI Preferably a corporate body e.g. NHS Trust must have direct contact to corporate body Person(s) Designated (PD) A person to whom the licence applies. Must be named on the licence. Other people can work under their direction

10 LTHT / UoL local communication arrangements There are clear governance arrangements in place for staff to ask questions / seek clarity on any HTA issues they may have Staff should: In the first instance, contact the Person (s) Designated (PD) for the relevant licence / area referred to (or the HTA Manager if you are unsure) If the PD is unable to answer the query he/she will pass it on to either: The Designated Individual (DI) for that licence OR The HTA Manager (as appropriate) If an answer can not be found internally, the DI (or HTA Manager) will contact the HTA via e mail and seek clarity

11 Codes Of Practice These give guidance and lay down expected standards: 1) Consent 2) Donation of solid organs for transplantation 3) Post mortem examination 4) Anatomical examination 5) Disposal of human tissue 6) Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation 7) Public display 8) Import and export of human bodies, body parts and tissue 9) Research

12 Relevant Material Defined as material that has come from a human body and consists of, or includes, human cells. 4 categories of relevant material: Cell deposits and tissue sections on microscope slides (as they will probably contain whole cells) Specifically identified relevant material Processed material Bodily waste products ( including excretions and secretions) Cell deposits and tissue sections on microscope slides These will probably contain whole cells

13 Specifically identified relevant material Includes: Bodily organs and tissues, skin, bone and blood (not for treatment) Stem cells created inside the human body Primary human cell cultures Excludes: Cell lines, hair and nail from living people Live gametes and embryos Cultured cells which have derived outside the human body Artificially created embryonic stem cells Extracted DNA Plasma extracted DNA There is a supplementary list to support the above on the HTA website

14 Processed material Where a processed material is generally agreed-as a result of the process- to leave it always either cellular or acellular, then the presumption should be that all examples should be regarded as such. Therefore: Plastinated tissue and body parts (where the cellular structure is retained by the plastination process) is generically regarded as relevant material Plasma or serum, generically regarded as not relevant material Bodily waste (including secretions and excretions) Bodily waste is a less characterised group of material HTA considers bodily waste should normally be considered as relevant material

15 Consent: The fundamental principle which underpins the HT Act. The giving of consent is a positive, voluntary act Penalties of up to three years' imprisonment or a fine, or both, are provided in the Act as a deterrent to failing to obtain or to misusing consent. The following are amongst the issues integral to the consideration of consent: - Is consent required? - Is it appropriate consent? - Is it valid consent? - What is the Scope of the consent? - What is the duration of the consent? - Are processes in place for the possible withdrawal of consent?

16 Appropriate Consent in summary: Self (where possible) Nominated Representative (if appointed) Qualifying relationship Other consent considerations are for children or adults lacking the capacity to consent Valid Consent in summary: Consent which is given voluntarily by an appropriately informed person, who has the capacity to agree to the activity in question

17 Scheduled Purposes Part 1: purposes generally requiring consent where the tissue is from the living or the deceased Anatomical examination requires witnessed consent in writing before death Determining the cause of death except where a post-mortem is ordered by a coroner Establishing after a persons death the efficacy of any drug or other treatment administered to him e.g. hospital post-mortem Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person) e.g. genetic information Public display requires witnessed consent in writing before death Research in connection with disorders or the functioning of the human body Transplantation - includes all bodily material such as blood, bone marrow, skin, tissue and organs

18 Part 2: purpose requiring consent where the tissue is from deceased persons Clinical audit Education or training relating to human health including training in research techniques Performance assessment e.g. testing medical devices Public health monitoring Quality assurance

19 Exceptions As well as licensing exemptions, the Act provides a No of exceptions to the general rule that appropriate consent is required. A statutory consent exemption applies if: The tissue is from the living and The researcher is not in possession, and not likely to come into possession of information that identifies the person from whom it has come and Where the material is used for a specific research project approved by a recognised* research ethics committee * = A university REC is not, for exemption purposes, a recognised REC. A REC established and working by UK Health Depts OR UKECA is a recognised committee.

20 If unsure, contact myself, Clare or Pat Harnden This discussion has been prepared to cover the basic, fundamental issues which relate to research support. For further info contact: Debby Gibson HTA Manager LTHT / UoL Tel: Mob: E mail: debbie.gibson@leedsth.nhs.uk