2. Research using human samples and
personal data
OUTLINE
Key points of the Human Tissue Act 2004 and application
to research
Key principles of the Data Protection Act 1998 and
application to research
Why is there a requirement for so much regulation?
Research misconduct
3. The Human Tissue Act 2004
Became law for researchers on Sept 1st 2006
WHAT IS IT?
Framework for regulating the removal, storage and use of
human tissue and organs in England, Wales and Ireland …
covers the living and the deceased
4. The Human Tissue Act 2004
KEY POINTS AND APPLICATION TO RESEARCH
Made consent the most important principle for the lawful
retention and use of human tissue
Made it illegal to store relevant material for research
without a licence … UNLESS it is being stored for a specific
ethically approved research project
Established the Human Tissue Authority to advise on and
ensure compliance with the Act, develop national operational
procedures and guidelines (Codes of Practice) and license
activities using human tissue
5. The Human Tissue Act 2004
CONSENT EXEMPTIONS FOR RESEARCH USING THE LIVING
Existing holdings pre Sept 1st 2006
If the material is anonymised AND there is ethical approval
6. The Data Protection Act 1998
WHAT IS IT?
The Data Protection Act 1998 defines UK law on the
processing of data on identifiable living people
It is the main piece of legislation that governs the protection
of personal data in the UK
Although the Act does not mention privacy, in practice it
provides a way in which individuals can control information
about themselves
7. The Data Protection Act 1998
KEY PRINCIPLES AND APPLICATION TO RESEARCH
Data may only be used for the specific purposes for which it
was collected
Data must not be disclosed to other parties without consent
Individuals have a right of access to the information held
about them
Personal information may be kept for no longer than is
necessary and must be kept up to date
8. The Data Protection Act 1998
KEY PRINCIPLES AND APPLICATION TO RESEARCH
Personal information may not be sent outside the European
Economic Area unless the individual has consented
Entities holding personal information are required to have
adequate security measures in place
Subjects have the right to have factually incorrect
information corrected
9. The Data Protection Act 1998
CONSENT EXEMPTIONS
National security, crime
Crime and taxation
Domestic use
Anonymised personal data is exempt from the DPA but
great debate over what ‘personal data’ is and what
‘anonymisation’ means
10. Why is there a requirement for so
much regulation?
1. Consent and the Human Tissue Act
Alder Hey
More than 2,000 pots
containing body parts
from around 850 infants
Removed and retained
(1988 – 1995) without
consent
Also stored without
consent 1,500 foetuses
that were miscarried,
stillborn or aborted
Alder Hey organ scandal ends with
final burial
18 January, 2010
A grim chapter in the Alder Hey organ scandal will come to
an end this month when the last human remains in the
possession of the hospital are laid to rest.
A final burial service will take place for tissue samples,
organs and foetuses which were never claimed by
relatives …..
11. Why is there a requirement for so
much regulation?
1. Consent and the Human Tissue Act
Results of Alder Hey report
Enquiry sparked in 1996 at Bristol Royal Infirmary not Alder
Hey
Over 104,000 organs, body parts and entire bodies of
foetuses and still-born babies were stored in 210 NHS facilities
without consent
Birmingham Children's Hospital and Alder Hey had given
thymus glands, removed from live children during heart
surgery, to a pharmaceutical company for research in return
for financial donations
12. Why is there a requirement for so
much regulation?
1. Consent and the Human Tissue Act
Results of Alder Hey report
Dutch pathologist Dick van Velzen had systematically
ordered the "unethical and illegal stripping of every organ
from every child who had had a postmortem" during his time
at the hospital – even for the children of parents who
specifically stated that they did not want a full post-mortem
CPS did not prosecute – no records – no proof!
Public outcry +++
13. Why is there a requirement for so
much regulation?
2. Ethical approval
Tuskagee syphilis study (1932
– 1972)
Penicillin found to be
effective in 1947
Researchers knowingly
withheld penicillin (and
knowledge of it) from
participants for 25 years
15. Is research misconduct still a relevant
issue?
2012
Neurosurgeons banned
from human research for
giving infectious bacteria
to brain tumour patients
Patients consented but
no ethical approval
16. Is research misconduct still a relevant
issue?
2012
Contact details of 3700
patients passed over to
private company without
consent
First NHS Trust to be fined
Written apologies
17. Is research misconduct still a relevant
issue?
June 2012
Brighton and Sussex University Hospitals NHS Trust fined
£325,000 for passing hard drives containing highly sensitive
patient data (> 10,000) to a company for destruction – they
had sub-contracted.
July 2012
St George’s Healthcare NHS Trust fined £60,000 after a
vulnerable individual’s sensitive medical details were sent to
the wrong address.
18. Research Concordat (2012)
…… A commitment to ensure that research is conducted
according to appropriate ethical, legal and professional
frameworks, obligations and standards
