Issue 19 - October 2009
Welcome to the October issue of the Human Tissue Authority's e-newsletter.
The e-newsletter is the main route by which we communicate changes to our regulatory policy and so is essential reading if you work in one of the sectors that we regulate. We also use it to let you know about new advice and guidance and important updates to our website. We now have nearly 6,000 subscribers.
This issue reports on our public Authority meeting in September, where we discussed living organ donation among other matters. You can also find out about the launch of our interactive codes of practice.
For Designated Individuals (DIs) from establishments that import / export, store or distribute acellular tissue for treatment, there is news about a training event in November. This issue also provides information about our project to evaluate the impact of legislation and the HTA regulation on research.
If you have any comments or queries about the issues raised in this e-newsletter, or any ideas for items you would like to see in future, please contact us at enquiries@hta.gov.uk.
Revised codes of practice: interactive and user-friendly
The HTA's revised codes of practice came into force on 15 September 2009 following Parliament's approval in July 2009. The codes, which provide guidance on the regulatory requirements of the Human Tissue Act for each of the sectors we regulate, are designed to support professionals by using examples based on real-life experience.
The codes are available in an interactive format on this website, providing user-friendly online access with links to other relevant issues and documents, and a ‘pop-up' glossary. You can print entire codes and individual sections in pdf format. Access the revised codes.
From 1 August to 14 November 2008, we held a public consultation on the revision of the codes of practice. The new codes reflect the stakeholder comments that we received and you can read a summary of the comments on this website.
Impact of legislation and HTA regulation on research
At the end of 2008, the HTA commissioned Opinion Leader to conduct an evaluation of perceptions on how human tissue legislation and its required regulation by the HTA has affected researchers working with human tissue.
Before undertaking the project we had heard anecdotal positive and negative feedback from people in the research sector about how human tissue legislation and HTA regulation was affecting their work. Concerns about the potential impact of the legislation were also raised during the passage of the Human Tissue Bill. We hoped that the project would clarify this issue by providing us with robust evidence about the impact of the legislation and HTA regulation on research.
You can read the results from the evaluation and our plans for taking the findings forward by downloading the report from the project.
Public Authority meeting, London
Our public Authority meeting took place in London on 24 September 2009. The meeting provided an opportunity for our stakeholders in London and the surrounding areas to observe the Authority discussing its business. 30 people attended the meeting, including members of the public and professionals.
The main agenda items discussed were informed consent in living organ donation, extending the HTA publication scheme and handling complaints within the HTA. The meeting papers are available from our meeting papers page.
Upcoming events
Training event for DIs from establishments that import / export, store or distribute acellular tissue for treatment, 12 November 2009
The HTA will be hosting a training event for all DIs involved in import / export storage or distribution of acellular material intended for human application. This training, which will take place at the HTA offices on 12 November 2009, will provide an opportunity for those DIs to satisfy their obligation to undergo training, to strengthen their understanding of their roles and responsibilities and to network with colleagues. Individuals who would like to take part should contact Veronica Lindop, Regulation Officer:
veronica.lindop@hta.gov.uk
Post mortem sector conference, 21 October 2009
The HTA's post mortem conference, ‘Working together, building confidence', has proven to be exceptionally popular and is fully booked. However, stakeholders who do not attend will not miss out. The HTA's December e-newsletter will include an update on the conference, including links to speakers' presentations on the website, and we hope that our communication channels, including our website, will help all DIs and Persons Designated working at HTA-licensed establishments, and representatives of relevant professional bodies, to explore possibilities for improvement and collaboration.
At the event itself, professionals working in the post mortem sector will receive face-to-face support and answers to any questions. We will also launch the 2009 summary report of compliance in the post mortem sector (see next item).
Summary of compliance reports
In October 2008, the HTA published a set of five summary inspection reports, reviewing each sector's compliance with HTA standards and highlighting relevant learning points. Later this month, we will launch six reports covering the 2008/09 business year, which give a clear summary and update of the extent of regulatory compliance and activity in each sector. The two largest reports are dedicated to the human application and post mortem sectors - the two that are at highest risk of non-compliance with HTA standards. There will also be an overview report covering all the sectors.
We hope that the information and guidance provided in these reports will enable individuals to gauge the standard of their establishment compared with others in their sector and to make improvements. Copies of all the reports will be available from our website, and we will contact all DIs and Licence Holders directly to provide a link to the reports.
Licensing and inspections update
Since the HTA began licensing in 2006, we have completed 691 phase one (desk-based) inspections and 313 phase two (site-visit) inspections across our five licensed sectors. Inspections are usually scheduled according to assessed risk; or on a reactive basis following receipt of information.
Information for the anatomy sector
Transfer or loan of cadaveric material when a DI is absent
In our code of practice on anatomical examination, we confirm the circumstances in which cadaveric material may lawfully be loaned by a DI, even if the receiving premises are not licensed by the HTA. The code gives detailed guidance (paragraphs 55 - 60) and our website provides a model loan form.
In the temporary absence of a DI, we advise that a Person Designated can authorise the loan, providing that the DI has put in place documented systems to ensure that the criteria for agreeing loans, and the processes governing them, are consistent. This delegation of responsibility should be formally recorded.
If you have any questions or comments, please contact Christopher Birkett, Head of Regulation, on 020 7211 3444 or email christopher.birkett@hta.gov.uk
Information for the organ and bone marrow transplant sector
Organ donations from living people
From 1 April 2009 to 24 September 2009, the HTA received 535 reports from Independent Assessors (IAs), 532 of which were approved. One case has already been referred to an HTA panel for decision and one case is due to be referred. One case is awaiting further information before a decision can be made. Since 1 April 2009, 21 cases have been referred to a panel of HTA members for a decision.
Bone marrow donations from children and incapacitated adults
From 1 April 2009 to 24 September 2009, we received 37 reports from Accredited Assessors (AAs), 37 of which were approved.
Recent media stories about human tissue
On 15 September 2009 we issued a media release about the launch of our revised codes of practice. This received coverage in the Nursing Times, Midirs.org and Bionews.
Following a site-visit inspection, the HTA took regulatory action in relation to post-mortem services at Cardiff and Vale University Local Health Board (formerly Cardiff and Vale NHS Trust) in August 2009 and this was covered by mediawales.org. Since then the HTA has worked with the hospital to help drive up standards and there was further coverage when we lifted the licence suspensions on 18 September 2009.
A study by University of Leicester researchers Emma Angell and Mary Dixon-Woods has found that the Human Tissue Act (HT Act) may have helped medical research. Fears that medical research using tissue such as blood or material from biopsies would be obstructed by the HT Act were unfounded, according to the study, the results of which were launched on 1 September. The results suggest that the HT Act may have helped medical research by giving Research Ethics Committees clarity when making decisions. The HTA is responsible for licensing organisations that store human tissue for research. This received coverage on lifesciencesworld.com among other websites.
Previous e-newsletters
Previous copies of the HTA's e-newsletter are available in the news and events section of our website.
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