Research and Knowledge Transfer seminar series

Jane Steele

Feb 12th 2013

Research using human samples and personal data

OUTLINE

Key points of the Human Tissue Act 2004 and application to researchKey principles of the Data Protection Act 1998 and application to researchWhy is there a requirement for so much regulation?Research misconduct

The Human Tissue Act 2004Became 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

The Human Tissue Act 2004

KEY POINTS AND APPLICATION TO RESEARCHMade consent the most important principle for the lawful retention and use of human tissueMade 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

The Human Tissue Act 2004

CONSENT EXEMPTIONS FOR RESEARCH USING THE LIVINGExisting holdings pre Sept 1st 2006If the material is anonymised AND there is ethical approval

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

The Data Protection Act 1998

KEY PRINCIPLES AND APPLICATION TO RESEARCHData may only be used for the specific purposes for which it was collectedData must not be disclosed to other parties without consent Individuals have a right of access to the information held about themPersonal information may be kept for no longer than is necessary and must be kept up to date

The Data Protection Act 1998

KEY PRINCIPLES AND APPLICATION TO RESEARCHPersonal 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 placeSubjects have the right to have factually incorrect information corrected

The Data Protection Act 1998

CONSENT EXEMPTIONSNational security, crimeCrime and taxationDomestic use

Anonymised personal data is exempt from the DPA but great debate over what ‘personal data’ is and what ‘anonymisation’ means

Why is there a requirement for so much regulation?1. Consent and the Human Tissue ActAlder HeyMore than 2,000 pots containing body parts from around 850 infantsRemoved and retained (1988 – 1995) without consentAlso stored without consent 1,500 foetuses that were miscarried, stillborn or aborted

Alder Hey organ scandal ends with final burial18 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 …..

Why is there a requirement for so much regulation?1. Consent and the Human Tissue Act

Results of Alder Hey reportEnquiry sparked in 1996 at Bristol Royal Infirmary not Alder HeyOver 104,000 organs, body parts and entire bodies of foetuses and still-born babies were stored in 210 NHS facilities without consentBirmingham 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

Why is there a requirement for so much regulation?1. Consent and the Human Tissue Act

Results of Alder Hey reportDutch 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-mortemCPS did not prosecute – no records – no proof!Public outcry +++

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

Is research misconduct still a relevant issue?

2011102 publications retracted

Is research misconduct still a relevant issue?

2012Neurosurgeons banned from human research for giving infectious bacteria to brain tumour patientsPatients consented but no ethical approval

Is research misconduct still a relevant issue?

2012Contact details of 3700 patients passed over to private company without consentFirst NHS Trust to be finedWritten apologies

Is research misconduct still a relevant issue?

June 2012Brighton 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 2012St George’s Healthcare NHS Trust fined £60,000 after a vulnerable individual’s sensitive medical details were sent to the wrong address.

Research Concordat (2012)

…… A commitment to ensure that research is conducted according to appropriate ethical, legal and professional frameworks, obligations and standards