1 / 22

Regulation by the HTA, raising standards for research and Brain Banking at Imperial

Regulation by the HTA, raising standards for research and Brain Banking at Imperial. Dr Kirstin Goldring Manager, UK Parkinson’s Disease Society Tissue Bank. Introduction. Tissue Banking and the Human Tissue Authority Background on the Tissue Banks at Imperial Aims of Tissue Banks Consent

alagan
Download Presentation

Regulation by the HTA, raising standards for research and Brain Banking at Imperial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. Regulation by the HTA, raising standards for research and Brain Banking at Imperial Dr Kirstin Goldring Manager, UK Parkinson’s Disease Society Tissue Bank

  2. Introduction • Tissue Banking and the Human Tissue Authority • Background on the Tissue Banks at Imperial • Aims of Tissue Banks • Consent • Tissue Bank statistics • Management of tissue donation • Tissue Processing • Ethics - Provision of tissue for research • HTA Inspection

  3. Background of the Tissue Banks at Imperial Licences for following sectors – Research Anatomy • Imperial College houses 2 National Tissue Banks as well as other tissue collections. • UK Multiple Sclerosis Tissue Bank >11 years • UK Parkinson’s Disease Society Tissue Bank >6 years • Charity funded grants • Human Anatomy Unit • Corsellis Collection

  4. Premises Recently moved to purpose built facilities Secure access, monitoring systems

  5. Objectives of the Tissue Banks To obtain and distribute High Quality human brain tissue, for research into Multiple Sclerosis (MS), PD and related disorders both in the UK and worldwide. • Recruitment into donor scheme • Collection of patient data, family histories, epidemiological details • Collection, processing and storage of human tissue • Distribution tissue to scientists • Raise public awareness, links with international research and interest groups • Follow regulations and comply with quality standards

  6. What tissue do we collect? Whole brain, spinal cord and CSF Who from? Anyone! Parkinson’s Disease and related movement disorders Multiple Sclerosis Controls – very important!

  7. Why is Tissue Banking important? Vital gift, Resource for Research Human Brain Tissue is VITALLY IMPORTANT for ongoing progress into the understanding and treatment of neurological disorders such as MS and PD MS and PD Tissue Banks both covered by the same HTA Licence

  8. Why is Tissue Banking important? “It is rewarding for people to know they can make a lasting gift that may help future generations of MS sufferers. It is important that those who donate and their families, know that tissue will be treated with respect and used only for good quality research” – Professor Richard Reynolds MS Tissue Bank “Human tissue is central to studying disease. Studying diseases without human tissue would be a bit like a bricklayer working without bricks… It is important because the doctors really do not know how MS acts on the body: and until they know, they can’t make further progress in finding new treatments” – Dave King, donated his wife’s tissue for research MS and PD Tissue Banks both covered by the same HTA Licence

  9. Donor Statistics Donor Statistics for PDS and MS Tissue Bank

  10. Interactions with the HTA • Working with the sector, not against • Invited to attend consultation workshop on development of licensing standards and regulatory framework • HTA visited us during the initial phase of designing the codes of practice and compliance reports. • Great deal of interaction with the sector by the HTA (views and training)

  11. The donor scheme - Consent Donor recruitment: follow government guidelines for donation information pack donor consent next of kin consent form GP copy of forms historical data on lifestyle and family Data Protection

  12. The donor scheme - Consent Informed and clear Consent underpins the Act Clear Codes of Practice on taking consent – ensured we are meeting We take prospective consent, provide an information sheet with clear explanation Training in taking consent, ensure forms complete and dated, need clear record, reconfirm at time of death

  13. What is involved in the donation procedure? Rapid collection of tissue is important (Aim - 24 hours) Death of registered donor Next of kin calls PDS Tissue Bank 24 hour emergency telephone number PDS Tissue bank immediately calls for further details and CONFIRM CONSENT Deceased transported to nearby hospital for tissue removal Body returned to funeral directors Tissue collected and stored at Hammersmith Hospital

  14. How do we arrange donations? Donations from all over the UK Work with the mortuary staff who retrieve the tissue for us Service Level Agreement: Tissue Bank to provide appropriate paperwork and instruction on tissue required as well as details for collection and transport of tissue Mortuary staff to provide facilities and staff for receipt tissue from the deceased.

  15. How the donated brain is processed? Cut into 2cm thick anterior and posterior slices For snap freezing Blocked into 2cm squares Blocks snap frozen in isopentane Blocks logged and stored in freezer For fixing Blocks cut into thin sections and put on slides Several weeks in fixative Blocks stained, standard and specific stains Staining analysed and report produced Specific blocks removed for analysis Cut into slices and examined by neuropathologist Researchers request tissue and info for research Remaining tissue blocked into 2cm squares Blocks snap frozen in isopentane Blocks logged and stored in freezer Lots of different tissue samples from each brain – TRACKING EVERY INDIVIDUAL SAMPLE IS VITAL

  16. Storage of tissue • Secure storage of tissue with back up • Anonymity of samples • Audit trail all tissue – whole brain to slides Disposal Tissue stored many, many years Respectful manner of disposal, following the way the tissue has been treated during the entire process

  17. Importance of Tissue Quality “One of the biggest problems in the research sector over the last 50 years has been the variability of tissue quality which can affect the outcomes of research. With the HTA, we now have an organisation that can make sure the appropriate quality standards are consistently applied across the board” – Professor Richard Reynolds MS Tissue Bank

  18. Tissue Quality and centralised repositories PDS and MS Tissue Banks are members of BrainNet Europe Consortium of 18 Tissue Banks from across Europe Improving techniques Shared expertise Standardisation of protocols HTA regulation and quality standards has strengthened this area

  19. How will the tissue be used? • Requests for tissue from recognised Institutions both in the UK and around the world. • The project is reviewed by an independent scientific panel, to check whether the project is scientifically sound and will benefit medical research. • Written report on the research carried out by the research team. • Acknowledgement of the Tissue Bank and MS/PDS in any scientific publication where donated tissue has been used.

  20. Ethics - NRES Beginning of the year applied through the new National Research Ethics System for status as a Research Tissue Bank NRES protects the safety, dignity and well being of research participants, whilst facilitating and promoting ethical research Tissue Bank Management Board (act as ethics committee) approve requests for tissue from those with peer review Speeds up amount of time in which tissue can be provided Ensures good quality tissue is being provided for good quality research

  21. HTA Inspection Detailed information and planning, well informed 13.30 – 13.45 Introductory meeting 13.45 – 14.45 Tour of premises and audit of records 14.45 – 15.00 Interviews with - PD 15.00 – 15.45 Interview with – 15.45 – 17.00 Review of documentation and completion of audit trail Feedback • Detailed and good advice • Allowed us to ensure we were meeting all the necessary standards • Consent • Governance and Quality • Premises, • Disposal Overall experience HTA • Approachable • Willing to listen • Supportive • Rapid responses

More Related