Transcript 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 material
Anatomical, physiological and
biochemical features
Resource for education, training
and research
Symbolic and cultural significance
Religious and secular beliefs
Emotional 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…”
Neil Armstrong
Research on tissue
from the living
Usually surplus tissue from
diagnosis or treatment
Anonymized tissue often sufficient
Identification of new treatments
Breast carcinoma: HER2
amplification and selection for
Herceptin treatment
Individualized cancer therapies
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
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 by
Saints Cosmas and Damian
Human tissue law
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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
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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 nonconsensual DNA analysis
should be criminalised
Human Tissue (Scotland) Act 2006
Human Tissue Act 2004
Human Tissue Act 2004
• Anything from a living or dead body and
containing human cells is “relevant material”:
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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
Anatomy
Post mortem
Information relevant
to another person
Transplantation
Public display
Research*
Consent required
only if material is
from the dead
Clinical audit
Education and
training
Public 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
Consent and licences for tissue research
The material
Donor
Purpose
Living Storage only for
ethicallyapproved
project
Dead
The law
Anonymised Consent Licence
No
Yes
No
Yes
No
No
Storage for
unspecified
research
No
Yes
Yes
Yes
No
Yes
Any material
n/a
Yes
Yes
Consent and licences for tissue research
The material
Donor
Purpose
Living Storage only for
ethicallyapproved
project
Dead
The law
Anonymised Consent Licence
No
Yes
No
Yes
No
No
Storage for
unspecified
research
No
Yes
Yes
Yes
No
Yes
Any material
n/a
Yes
Yes
Research
idea
Ethics
committee
Research
project
Better
treatment
The burden of regulatory ethics
Re-apply?
Research
idea
Ethics
committee
Think
again
Better
treatment
Ethical (NRES) approval of research
using banked or archived tissue
REC approval of the
tissue bank:
Tissue from diagnostic
archives:
 Bank must have HTA
licence
 Diagnostic archives
cannot be HTA licensed
 Automatic approval of
all projects conforming
to set criteria
 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
From Bryant RJ, et al. J Clin Pathol 2008;61:322–326
Most frequent
objection is to use for
transplantation
www.hta.gov.uk