1. Human tissue:the matter of life and death James Underwood Emeritus Professor of Pathology, The University of Sheffield Member, Human Tissue Authority

2. Properties of human tissue Diagnostic material Anatomical, physiological and biochemical features Resource for education, training and research Symbolic and cultural significance Religious and secular beliefs Emotional associations

3. Neil Armstrong “… you took hair you had cut from Mr Armstrong’s head and, without requesting permission from or even advising Mr Armstrong, sold that hair to Mr Mueller…”

4. Breast carcinoma: HER2 amplification and selection for Herceptin treatment Research on tissuefrom the living Usually surplus tissue from diagnosis or treatment Anonymized tissue often sufficient Identification of new treatments Individualized cancer therapies

5. The Moore case John Moore diagnosed with hairy cell leukaemia (1976) Splenectomy sampled for research Cell lines patented (1984) Moore sues University of California Case settled (1990): ‘fiduciary duty’ to inform Moore of financial interest in his tissues

6. Research on autopsy tissue Hypertrophic obstructive cardiomyopathy Variant CJD

8. Human tissue law • Murder Act 1752 • Corpses of executed murderers could be used for dissection The Reward of Cruelty (William Hogarth)

9. Human tissue law • Murder Act 1752 • Anatomy Act 1832 • Lawful to use unclaimed corpses • Consented donation • Licensed anatomists The Resurrectionists (Thomas Rowlandson)

10. Human tissue law • Murder Act 1752 • Anatomy Act 1832 • Human Tissue Act 1961 • Lawful to use tissue after death for treatment, education or research if no relative objects Limb transplantation by Saints Cosmas and Damian

11. Human tissue law • Murder Act 1752 • Anatomy Act 1832 • Human Tissue Act 1961 • Human Tissue Act 2004 • The living and the dead • The “golden thread” of consent • Regulation by licensing

12. Human tissue law • Murder Act 1752 • Anatomy Act 1832 • Human Tissue Act 1961 • Human Tissue Act 2004 • Coroners (Amendment) Rules 2005 • Coroner must inform relatives about retention • Relatives choose to donate or discard

13. Genetic analysis Consultation by Human Genetics Commission (2000) Recommended that non-consensual DNA analysis should be criminalised

14. Human Tissue (Scotland) Act 2006 Human Tissue Act 2004

15. Human Tissue Act 2004 • Anything from a living or dead body and containing human cells is “relevant material”: • tissue biopsies • whole organs • blood • urine, saliva, faeces, etc • Nails, hair and gametes excepted • Human Tissue Authority issues licences • Consent required for “scheduled purposes” • Penalties for offences (e.g. 3 years in prison)

16. Schedule 1 of HT Act 2004 *Unless from a living individual, anonymised and REC (NRES) approved

17. Consent: the “golden thread” in the HT Act 2004 Except for anatomy and public display, consent is not defined in the Act Consent is elaborated in HTA’s code of practice Consent is a process, not a signature on a form

18. Consent and licences for tissue research

19. Consent and licences for tissue research

20. Research idea Research project Better treatment Ethics committee

21. The burden of regulatory ethics

22. Re-apply? Research idea Think again Better treatment Ethics committee

23. REC approval of the tissue bank: Bank must have HTA licence Automatic approval of all projects conforming to set criteria Tissue from diagnostic archives: Diagnostic archives cannot be HTA licensed REC approval required for each project Ethical (NRES) approval of research using banked or archived tissue

24. Public support for research 220 post-operative patients in Sheffield 96.3% do not object to use of their tissue for research Most frequent objection is to use for transplantation From Bryant RJ, et al. J Clin Pathol 2008;61:322–326

25. www.hta.gov.uk