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