Human tissue in research

Question 1

What ethical issues are raised by the need to use human tissue in research?

Answer 1

• Privacy and anonymity (patients get given a biobank number for privacy)
• Beneficence (do good)
• Non-maleficence (do no harm)
• Autonomy
• Bodily integrity
o In Liverpool in 1980’s children’s organ and tissue was used for pathological research and parents were unaware

Question 2

Explain the Human Tissue Act (HTA) 2004

Answer 2

• The ‘Human Tissue Authority’ regulate the HTA 2004
• Regulates the removal, storage, use and disposal of human bodies, organs and tissue.
• Provides principles for using human tissue from living and deceased patients in:
• > Storage
• > Research
• > Transplantation
• > Anatomy
• > Public display
• > Covers relevant material (i.e. most body parts but not some like hair and nails)
• > Gametes and embryos are covered by another act (Human Fertilisation Embryology Act 2009)
• > Ensures consent and licensing are obtained

Question 3

Explain the Human Tissue (Scotland) Act 2006

Answer 3

Slightly different to HTA 2004 but rules are consistent with HTA 2004

Question 4

Explain why consent is important in relation to use of human tissue in research?

Answer 4

• Principle underlying the lawful retention and use of “relevant human material”
• Needed for:
• > Storage
• > For research on linked samples (i.e. where clinical info is linked)
• > For DNA analysis
• Consent can be specific (for one project) or broad (for multiple projects)

Question 5

What is licensing and why is it needed?

Answer 5

• Gives legal permission for the use of human tissue
• Required for any research project except when tissue has been stored for an ethically approved research project from the start
• NO LICENSE NEEDED:
• > Tissue used for diagnosis
• > Tissue with specific project ethics approval already
• LICENSE NEEDED:
• > Using left over patient material from diagnostic samples
• > For a future project that has not yet been planned (as storage is needed)
• > To distribute tissue to other researchers

Question 6

What are the circumstances in which generic research consent is valid?

Answer 6

• Tissue which is an “existing holding”, i.e. it was already held before 1 September 2006
• Tissue which has been taken from a living person AND the researcher is not able to identify the person and the research project is ethically approved by a REC
• Imported tissue.

Question 7

Give examples of where consent is not needed:

Answer 7

ALL IN STUDIES INVOLVING LIVING PEOPLE
• Audits
• Education
• Performance assessment
• Public health monitoring
• Quality assurance (e.g. checking an assay works)
• Research on anonymised samples (non-linked samples)

Question 8

What is the role of Human Tissue Banks as part of a framework facilitating access to human tissue for research in conformity with the Law?

Answer 8

• To collect and manage human tissue for research
• Their roles:
• > Make arrangements to critique scientific projects to ensure that they are using tissue appropriately
• > Ensure consent and anonymity of samples
• > Organise material transfer arrangements
• > Make an annual report of projects which receive human materials

They check the standard of quality of research with 5 criteria:

1. Consent
2. Governance – e.g. standard operating procedures in labs
3. Access – samples given a CHI and ensure there are documented procedures in place for sample distribution
4. Data and audit trail availability – everything coded
5. Quality assurance – premises fit for purpose, security, systems in place to protect tissue during transport

Question 9

Why do we need to ethically review tissue banks, and what are the main issues in such a review?

Answer 9

There are 4 committees in the West of Scotland carry out ethical review of tissue banks and:
o Approve use of tissue in projects
o Provide a continuing line of ethical accountability
o Involve all clinician types in the committee