Human tissue: the matter of life and death
description
Transcript of Human tissue: the matter of life and death
Human tissue:the matter of life and death
James Underwood
Emeritus Professor of Pathology, The University of Sheffield
Member, Human Tissue Authority
Properties of human tissue
Diagnostic materialAnatomical, physiological and biochemical featuresResource for education, training and research
Symbolic and cultural significanceReligious and secular beliefsEmotional associations
“… 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…”
“… 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
Research on tissuefrom 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 therapiesBreast carcinoma: HER2 amplification and selection for Herceptin treatment
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
Research on autopsy tissue
Hypertrophic obstructive cardiomyopathy Variant CJD
Human tissue law
• Murder Act 1752– Corpses of executed
murderers could be used for dissection
The Reward of Cruelty (William Hogarth)
Human tissue law
• Murder Act 1752• Anatomy Act 1832
– Lawful to use unclaimed corpses
– Consented donation– Licensed anatomists
The Resurrectionists (Thomas Rowlandson)
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 bySaints Cosmas and Damian
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
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
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
Human Tissue Act 2004
Human Tissue (Scotland) Act 2006
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)
Schedule 1 of HT Act 2004
Consent always required
Consent required only if material is
from the deadAnatomy
Post mortem
Information relevant to another person
Transplantation
Public display
Research*
Clinical audit
Education and trainingPublic health monitoring
Quality assurance
*Unless from a living individual, anonymised and REC (NRES) approved
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
Consent and licences for tissue research
The material The law
Donor Purpose Anonymised Consent Licence
Living Storage only for ethically-approved
project
No Yes No
Yes No No
Storage for unspecified
research
No Yes Yes
Yes No Yes
Dead Any material n/a Yes Yes
Consent and licences for tissue research
The material The law
Donor Purpose Anonymised Consent Licence
Living Storage only for ethically-approved
project
No Yes No
Yes No No
Storage for unspecified
research
No Yes Yes
Yes No Yes
Dead Any material n/a Yes Yes
Researchidea
Ethicscommittee
Bettertreatment
Researchproject
The burden of regulatory ethics
Researchidea
Ethicscommittee
Thinkagain
Bettertreatment
Re-apply?
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
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
www.hta.gov.uk