Information Session 2

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Information Session 2 May 2006


The HTRC is jointly funded by
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• Collaborative approach between the Trust and the
  School
• Improvements in efficiencies
• Centralised record tracking system between
  organisations enables effective use of resources
• Improve care processes and clinical outcomes as
  well as eliminating the potential for litigation
• Providing a pool of resources and services to
  local and commercial research groups

Human Tissue Resource Centre Why a centralised
tissue bank for research?


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The HTRC will undertake a range of managerial,
financial and operational functions, centred on
the management and distribution of samples,
record keeping and physical storage of human
tissue samples for future undefined research.
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Human Tissue Resource Centre HTA Licensing for
the Trust/Medical School Who needs to be licensed?


No licence required
Licence for carrying out a post mortem, public
display or anatomy
Yes but separate consent to store tissue for
future research
Diagnostic purposes (taken from living only)
Other purpose
Are you storing tissue for a future undefined
project or a project without ethical approval?
Are you storing tissue for a specific research
project with ethical approval?
Are you storing tissue to distribute to other
researchers?
What is the primary purpose you store organs,
tissue or cells for?
Is the stored material created outside the human
body (eg cell line)?
No
No
No
Yes
Research purposes (taken from living or deceased)
Yes
Licence required from 1 Sept
Licence required from 1 Sept
Yes
Yes
No licence required
No licence required
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• Storage of human tissue for research
• 29 registrations received
• 9 from Charterhouse Square, including Institute
  of Cancer and the Wolfson Institute of
  Preventative Medicine
• 18 in the Royal London and related sites,
  including the Dept of Medicine, Clinical Biochem,
  Adult Oral Health, Centre of Adult and Paed
  Gastro, Dental Institute and ICMS
• 1 from the London Chest Hospital
• 1 from QMUL Mile End Campus

Human Tissue Resource Centre Registration


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For a Registration and Listing form contact
Belinda Seeto, Project Manager 020 7601 7521
(x15 7521) or belinda.seeto_at_bartsandthelondon.nhs.
uk
Human Tissue Resource Centre


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• Estimated 14 000 to 40 000 samples of Human
  Tissue/Cell/Blood/Blood based products for
  research is expected to be collected per year
  (after April 2006)
• Estimate excludes residual tissues collected by
  the HTRC.
• 14 centres will collect 1-100 samples
• 7 centres will collect 101-500 samples
• 2 centres will collect 501-1000 samples
• 3 centres will collect 1001-5000 samples
• 2 centres will collect 5001-10000 samples
• 1 centre did not identify number of samples

Human Tissue Resource Centre


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• Compliance Report contains 4 categories
• Consent
• Governance and Quality Systems
• Premises, Facilities and Equipment
• Disposal

Human Tissue Resource Centre How do we comply?


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• DONT PANIC!!!
• No compliance No licence No jobs!
• Communicate talking and liaising
• with members of the Trust and
• Medical School changes cannot
• happen on their own. Dont expect it
• will all be taken care of
• GET INVOLVED!

Human Tissue Resource Centre What do we need to
do?


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• Show that consent is obtained consent forms
• Training for staff training records
• Staff and user feedback questionnaires
• Standard Operating Procedures document control
  system
• Record system to trace human tissue samples
• Premises fit for purpose risk assessments
• Security, integrity and quality for storage of
  human tissues
• Clear disposal policies

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Human Tissue Resource CentreWhat do we need to
do?

• Talk to each other
• Read the codes, guidance notes
• Plan what needs to be done
• Action SOPs
• document system/database
• training and support
• Monitor make sure the system works get
  feedback
• Review Regular, auditable system

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• Identify yourselves - register with the HTRC
• Contact Belinda Seeto, Project Manager
• 020 7601 7521 (x15 7521)
• Belinda.Seeto_at_bartsandthelondon.nhs.uk
• HTRC has information on the RD website under
  Research/ For staff / Human Tissue Resource
  Centre
• Visit the HTA website - http//www.hta.gov.uk
• Visit the Department of Health website -
  http//www.dh.gov.uk/ under Policy and guidance /
  Health and social care topics / Tissue

Human Tissue Resource Centre


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Human Tissue Resource Centre


Bringing excellence to life