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. “… 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…” Neil Armstrong

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

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

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

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 Consent always required Consent required only if material is from the dead Anatomy Post mortem Information relevant to another person Transplantation Public display Research* Clinical audit Education and training Public health monitoring Quality assurance * 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 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 The materialThe law DonorPurposeAnonymisedConsentLicence Living Storage only for ethically- approved project NoYesNo YesNo Storage for unspecified research NoYes NoYes DeadAny materialn/aYes

19. Consent and licences for tissue research The materialThe law DonorPurposeAnonymisedConsentLicence Living Storage only for ethically- approved project NoYesNo YesNo Storage for unspecified research NoYes NoYes DeadAny materialn/aYes

20. Research idea Ethics committee Better treatment Research project

21. The burden of regulatory ethics

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

23. Ethical (NRES) approval of research using banked or archived tissue 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

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 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