Jane Steele: Research Using Human Tissue - Good Practice
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Research Using Human Tissue: Good Practice Jane Steele November 28 th 2011
Transcript of Jane Steele: Research Using Human Tissue - Good Practice
Research Using Human Tissue: Good Practice
Jane Steele
November 28th 2011
Based on Codes of Practice produced by HTACode of Practice 9: Research
Expectations of HTA (and CMDS)
Not just ‘tissue’
What is relevant material?
The fundamental principle remains that if a sample is known to contain even a single cell that has come from a human body, then the sample should be classified as relevant material
1.Obvious relevant material e.g. organs, tissue, blood, bone, skin etc
2.Bodily waste products e.g. urine, faeces, lung lavage, sputum
3.Cell deposits and sections on microscope slides
What is not relevant material?
1. Processed material which renders it acellular e.g. serum, plasma, DNA/RNA, urine, antibodies
2. Cell lines passaged or created outside of the body
3. Lysed cell products
Few key points .....
Storage and use should be in line with original consentStorage of relevant material without NRES ethical approval is illegal without an HTA licenceSeven day rule
Expected standards1. Governance and quality
Documented procedures and related risk assessmentsTraining and staff developmentAuditAdverse event reporting• Non-compliance with HTAct e.g. consent• Damage to sample integrity
Expected standards1. Governance and quality (contd)
Record keeping • Document consent• Traceability of all samples (uniquely identified)
Storage locationsCurrent project and PITransferDisposal
Expected standards2. Premises, facilities, equipmentPremises and facilities should be ‘fit for purpose’
= Safe for researchers and preserve sample integrity• Secure storage areas• Maintenance of equipment• Clear labelling• Temperature monitoring• Transport• Contingency arrangements
Human Biomaterials Resource Centre (HBRC)
North West 5 Research Ethics Committee
Haydock Park (Ref 09/H1010/75)
Samples in
HBRC approved consent
Samples out
Under HBRC ethics
NO REQUIREMENT FOR PROJECT-
SPECIFIC ETHICS
What does the consent cover us to collect and store?
Tissues surplus to diagnosis
Waste tissues
Additional samples taken specifically for research
Clinical data and long term outcome data
And in terms of research use?
Use in genetic studies
Use in research which may involve animals
Research outside of Birmingham
Research in the commercial sector
Where can we collect from?
UHBFT ROH
BWH
SWBH
HEFT
BCH
BSMHFT
UHCW
Dental Hospital
