1. The Human Tissue Act and You Steve Hopkins Designated Individual for Research Tissue http://www.hope-academic.org.uk/irr/hta/

2. Aims  Brief introduction to the HTA  To explain the role of the Designated Individual, Licence Holder and Persons Designated  To summarise what is regulated  To explain how this affects you

3. Review of the Law 2000-2004  Bristol / Alder Hey / Isaacs Reports  CMO recommendations - January 2001  Retained Organs Commission  Consultation on review of the law

4. Human Tissue Act  The Human Tissue Act 2004 (HT Act) repeals and replaces the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they relate to England and Wales, and the corresponding Orders in Northern Ireland.

5. Human Tissue Act  The HT Act makes consent the fundamental principle Storage and use of body parts, organs and tissue from the living or deceased for specified purposes Storage and use of body parts, organs and tissue from the living or deceased for specified purposes Removal of material from the deceased Removal of material from the deceased

6. Two HTAs  Human Tissue Act (HT Act): Legislation underpinning lawful storage and use of tissue from the living or the deceased and removal of such material from the deceased.  Human Tissue Authority (HTA): Established to regulate activities under the Act

7. The HTA’s 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

8. Licensed Sectors  Tissue for human application  Post Mortem services  Anatomy  Public display  Research

9. Licensing under the HT Act 2004  One activity per licence  A licence must specify the premises where the activity is to be carried out  A licence cannot authorise licensed activity on premises at different places  One person (Designated Individual) supervises the activities under a licence

10. HTA Governance Framework  Designated Individual  Licence applicant (if different to DI)  Person Designated: a person to whom the Licence applies  Persons acting under the direction of a DI or Person Designated by DI

11. HTA Governance Framework DI Persons Designated Persons working under the licence Persons working under the licence Licence

12. Licence Holder  Licence holder (if different to DI) Must have consent of DI for application Must have consent of DI for application Can be a corporate body: e.g. NHS Trust Can be a corporate body: e.g. NHS Trust Can apply to vary licence to remove DI without his/her consent Can apply to vary licence to remove DI without his/her consent

13. The Role of the Designated Individual (DI)  Specific responsibilities as set out in section 18 of the Human Tissue Act  The DI is the person under whose supervision the licensed activity/ies are authorised to be carried on  Must be in a position to secure that activities are conducted properly by people who are suitable to carry out those activities

14. Person Designated  Person designated as a person to whom the licence applies Must be named in a notice given by the DI to the Authority Must be named in a notice given by the DI to the Authority Other people can work under the direction of this person Other people can work under the direction of this person

15. Governance  Persons acting under the direction of a DI or Person Designated Any person Any person  Responsible Person under the EUTCD Must have scientific or medical experience Must have scientific or medical experience

16. Human Tissue Act  The HT Act makes consent the fundamental principle Storage and use of body parts, organs and tissue from the living or deceased for specified purposes Storage and use of body parts, organs and tissue from the living or deceased for specified purposes Removal of material from the deceased Removal of material from the deceased

17. Ethics and HTA  Human Tissue Act – Statutory  Ethical Approval – Is not

18. Research Tissue Storage: Does it Require a Licence?  Tissue removal Tissue removed and stored for the primary purpose of diagnosis or treatment - No Licence Tissue removed and stored for the primary purpose of diagnosis or treatment - No Licence Tissue removed and stored to determine the cause of death – Post Mortem Licence Tissue removed and stored to determine the cause of death – Post Mortem Licence  Tissue removed and stored for the primary purpose of research A specific research project with ethical approval – No Licence A specific research project with ethical approval – No Licence Distribution to other researchers (tissue bank) – Licence Distribution to other researchers (tissue bank) – Licence A possible project in the future – Licence A possible project in the future – Licence

19. PRIMARY PURPOSE: Research Yes, unless material is obtained from a living person and is anonymised Is it stored for a specific ethically approved research project? Yes No Is a licence required? Yes Is consent required? Yes Is consent required? No

20. Specific Ethically Approved Project  Is use of tissue if defined clearly within an ethically approved project  Is not unspecified research on a specified disease (e.g. ‘For research to prevent growth of brain tumours’  Is not research where the tissue collection is specified in an ethics application but the specific use is not.

21. Relevant Material  Consists of / includes cells – except gametes, embryos, hair or nails  Processed material, unless acellular  ‘Waste products’, unless acellular  Isolated cells – except cell lines

22. NRES & Tissue

26. Ethically Approved Tissue Bank  Voluntary  2 Types 1) Ethical approval for storage Or 2) Ethical approval for storage and use

27. Tissue Scenario 1  Study collects blood from patient group  Store plasma for specified hormone measurement  Whole blood sample sent to a university for DNA extraction and storage  Keep remainder of plasma for later research without current approval No Licence issue: blood may be an issue for the university, if stored, but plasma is not regulated

28. Tissue Scenario 2  Study collects blood from patient group  Store plasma for specified hormone measurement  DNA extracted immediately for storage and subsequent studies  Keep remainder of plasma for later research without current approval No Licence issue: plasma and DNA storage are not regulated

29. Tissue Scenario 3  Skin samples collected from patients and volunteers for evaluation of structural proteins  Blood stored for later extraction of DNA to analyse genes for these proteins No Licence issue: both tissues stored for specified research

30. Tissue Scenario 4  Muscle biopsies collected from patients for evaluation of defined muscle proteins for a study of myaesthenia  Blood stored for later studies of the genetics of muscle disease There is a Licence issue: the research use of the blood is not specifically defined

31. Tissue Scenario 5  Clinical trial collects blood and plasma samples for analysis of drug levels, defined metabolites and genes identifying susceptibility to the trial drug  Stored in trials unit to be sent to drug company at 3 month intervals No Licence issue: the blood is stored for a specific research project

32. Tissue Scenario 6  Clinical trial collects blood and plasma and urine samples for analysis of drug levels, defined metabolites and to establish bank of tissue for future identification of drug targets.  Stored in trials unit to be sent to drug company at 3 month intervals There is a Licence issue: blood is stored for more than 7 days before transport and not for a specific project

33. Tissue Scenario 7  Kidney biopsies collected for diagnosis and stored in the Histopathology Department  Ethically approved project requests release to a research group to analyse tubule proteins No Licence issue: the tissue has been stored for diagnosis and the specific project is ethically approved

34. Tissue Scenario 8  Lung tissue collected by ethically approved tissue bank with authority to approve projects using tissue  Sends tissue for a research project at a University with no HTA Licence and no NRES/IRAS approval There is a Licence issue but storage is under License (or the bank would not have been ethically approved) and can grant approval for subsequent projects

35. Tissue Scenario 9  Consent obtained from patients for storing tumours removed at surgery, for future research on brain tumours  No Ethical Approval applied for  No current research study being undertaken What approvals needed? An HTA Licence and approval of the DI

36. Designated Individual for Research Tissue Steve Hopkins: Ext - 64269 http://www.hope-academic.org.uk/irr/hta/