Issue 5: May 2007
Welcome to the May issue of the Human Tissue Authority’s e-newsletter which provides updates for all the sectors we regulate.
In this issue we update the human application sector on the new Regulations which will implement the EU Tissue and Cells Directive. We also provide important information on using anatomical specimens for the anatomy community.
There have been a number of major media stories linked to the work of the HTA since the last e-newsletter. You can find out more about these below.
If you have any comments or queries about the issues raised in this e-newsletter, or any ideas for items that you would like to see in future, please contact us at enquiries@hta.gov.uk
Licence fees for 2007/08
Thank you to everyone who responded to our consultation on licence fees. We published the confirmed licence fee structure for 2007/08 at the beginning of April.
Clarification of licence fees for the public display sector
The licence fee for public display establishments is £3600 per annum for the main site and £500 per annum for satellite sites. However, for establishments exhibiting fewer than 20 items, the licence fee is £250 per annum. The lower charge reflects the difference in work needed to regulate this sector: public display standards are not as detailed as the other sectors, so require slightly less evaluation. We are also likely to inspect these establishments much less frequently because of the low risk they present.
Designated Individual training
We have received very positive feedback from our new sector-specific training days for Designated Individuals (DIs). The dates for future training days are:
- Post mortem sector – 5 June at the Law Society, London
- Research sector – 10 July at the Law Society, London
- Anatomy and public display sectors – 26 July at the Law Society, London
If you would like to attend one of these days, please register or email di@hta.gov.uk . DIs that have not yet received training will be prioritised. If you have any questions about DI training please contact Carly Tutty at di@hta.gov.uk or phone 020 7211 3438.
E-learning for DIs
We will be launching an e-learning package to train DIs later this year. We would like to involve as many DIs as possible in developing the new system, so that we can make sure it meets their needs. If you would like to be involved in user testing, please email us at di@hta.gov.uk
Relevant material
In our last e-newsletter we announced that we had published guidance on the definition of what the Human Tissue Act 2004 (HT Act) refers to as ‘relevant material’ for the purpose of licensing. This guidance divides potentially relevant material into three categories in order to help define whether or not it should be subject to licensing. Read the relevant material guidance. We are currently holding a series of discussions with key stakeholders about the implications of the guidance. Further information will be provided in future issues of the e-newsletter. All tissue or cells stored or processed for human application will be subject to regulation under the EU Tissue and Cells Directive (EUTCD).
Update on recent media stories about human tissue
Sellafield investigation
One of the major stories has been the news of an official investigation into claims that human tissue was taken from deceased nuclear workers at Sellafield without consent. Alistair Darling, Secretary of State for Trade and Industry made an emergency statement in the House of Commons on 18 April 2007 and Michael Redfern QC has been invited to carry out the investigation. We released a statement on the Sellafield investigation.
Payment for kidney donation
Other media issues have included the story of Mr Dan Tuck who was convicted under the Human Tissue Act 2004 for trying to sell his kidney on the internet. BBC radio and a number of national newspapers covered this story.
Stem cells
There was media interest surrounding the launch of the UK Stem Cell Bank and its apparent difficulties gaining accreditation. We released a statement on this issue.
We subsequently issued a joint statement with the HFEA and MHRA on the regulation of stem cell research for human application. A meeting is planned in June between the regulatory bodies and the UK stem cell bank community with the aim of clarifying the regulatory arrangements for stem cell research. We are planning to publish a series of frequently asked questions about stem cells and these will be available on our website shortly.
Business and Strategic Plans
We have recently published our new Business and Strategic Plans. These explain how the HTA is going to move from setting up systems, processes and policies to reviewing, refining and embedding them.
If you would like to find out more about our plans for the future, visit the governance page of this website.
Regulatory Authority for Tissue and Embryos (RATE) Bill
Pending legislation, the new Regulatory Authority for Tissue and Embryos (RATE) will combine the statutory functions that are currently the responsibility of the HTA and the Human Fertilisation and Embryology Authority.
The draft Bill for RATE (called the Human Tissue and Embryos Bill) has now been published for pre-legislative scrutiny and is available on the Department of Health website. Our statement on the draft bill is available on this website. The draft Bill will be scrutinised by a joint House of Lords and House of Commons Committee. The Scrutiny Committee has published information about the way in which it will take evidence from, amongst others, the HTA's public and professional stakeholders, this is available to read online. The Committee will report on the draft bill by 25 July 2007.
Living-donor transplants update
Organ donations
From 1 September 2006 to 10 May 2007, 441 reports from Independent Assessors (IAs) were submitted to the HTA, 430 of which have been approved. Two cases have not been approved, and nine cases are awaiting more information before they can be adequately assessed. To date, only one case has been referred to a panel of HTA members for a decision.
We are organising a conference for IAs which will take place in October 2007. Its purpose is to review the HTA’s first year of regulating living organ donation and to thank all IAs for the part that they have played in making it such a success. More details about the conference, including the confirmed date, will be published on this website soon.
Bone marrow transplants
From 1 September 2006 to 10 May 2007, 64 reports from Accredited Assessors were submitted to the HTA, all of which have been approved.
Tissue for human application – update on new Regulations
The new Human Tissue (Quality and Safety for Human Application) Regulations 2007 have now been approved by Parliament and come into force on 5 July 2007. These Regulations will implement the full requirements of the EUTCD.
When this happens, the HTA’s remit will be extended to include licensing the following activities:
- procurement
- processing
- storage
- testing
- distribution
- import and export
The Regulations will also broaden the HTA’s remit to ensure stem cell lines, cell lines grown outside the human body and donor lymphocyte infusions for use for human application are covered by the licensing requirements (see section on stem cells above).
We are pleased to say that if you already have an HTA licence to store material for human application, you will be automatically be licensed by the HTA for the activities listed above. If not, and you conduct the activities listed above, you will need to apply for a licence or set up a formal agreement with an establishment that has an HTA storage licence.
How do I apply for a licence?
If you think that you need to apply for a licence please email us as soon as possible at enquiries@hta.gov.uk . We can then provide you with further advice. If you do need a licence you will be able to apply online from 1 July 2007.
In advance, we will be publishing a document which contains all the questions that you will be asked in the application form. This will help you to prepare answers in advance of actually completing the online form. This pdf document will be available to download from this website on 31 May 2007.
EUTCD Directions
In April 2006 we published a set of Directions (expected standards) for establishments storing tissue for human application. These Directions summarised the requirements of the first technical directive of the EUTCD.
We will shortly be publishing a new set of Directions which summarise the requirements of the Human Tissue (Quality and Safety for Human Application) Regulations and the second technical directive of the EUTCD. When published, these Directions will be available on the website.
Information for the research and post mortem sectors
COREC changes its name
On 1 April 2007, the Central Office for Research Ethics Committees (COREC) was relaunched as the National Research Ethics Service (NRES). NRES is made up of the COREC head office and NHS Research Ethics Committees (RECs) in England. NRES will also work with colleagues in Scotland, Wales and Northern Ireland to maintain the UK wide framework for ethical review of research. Further information is available on the NRES website.
NRES has published a series of frequently asked questions on issues relating to research involving human tissue.
Review of diagnostic archives by NRES
Diagnostic archives are a very valuable source of material for research. For this reason, our licence application form for post mortem services allows applicants to apply for a licence to store material for research without any extra fee.
NRES have told us that they have been asked to ethically approve some diagnostic archives as establishments storing tissue for research. NRES will not ethically approve a diagnostic archive as a tissue bank unless the establishment has an HTA licence to store material for research. If you need any further information on this issue please contact the relevant Head of Regulation for your geographical region.
Information for the anatomy and public display sectors
This section of the e-newsletter provides updates on specific issues which affect the anatomy sector. You can find out more and download the documents mentioned in this section on the anatomy schools page of this website.
Communications to crematoria
Some anatomy schools use forms to communicate with crematoria as part of the process for requesting the cremation. To ensure that crematoria are up to date with changes under the Human Tissue Act 2004 (HT Act), we have produced a template form which medical schools can use. Download this form.
Signing on behalf of a donor
It is a requirement of the HT Act that consent to donate a body for anatomical examination is made in writing by the person themselves and witnessed. The HTA realises that written consent may not always be possible from a potential donor, for example due to illness. In such cases, a family member or next-of-kin may sign under the direction of the donor. The HTA has produced a model consent form for anatomy schools to use for this purpose. Download this model consent form.
This consent form should only be used in exceptional circumstances, as it is always preferable to have written consent from the donor.
Taking and using images of anatomical specimens
Our model consent form for anatomical examination includes a section where donors can consent to images being taken for medical education, training and research provided that they are not identifiable. No additional licence is needed by anatomy establishments to take these images.
Our policy is that non-identifiable images of anatomical specimens (donated after 1 September 2006 – when the HT Act came into force) may be used in paper publications for teaching or research purposes. Electronic images may be used on restricted 'intranet' networks within educational establishments, but should be 'download protected'. Anatomical images should not be posted on the internet, where they may be accessed and downloaded by the general public.
Images may also be taken of bodies and body parts bequeathed under the Anatomy Act, and of historical anatomical museum specimens of unknown provenance which are deemed to be legitimately held, as long as the donor is not identifiable. The DI should keep records of any images, including detail of the images made, their origin and where they were used.
Use, storage and disposal of pathology, anatomy and animal specimens
We have received some enquiries in relation to the use, storage and disposal of pathology, anatomy and animal material. We advise that the use of pathology, anatomy and animal material (e.g. for teaching and research purposes) may be conducted in the same place, if undertaken properly. However, the storage and disposal of animal specimens and human tissue should be separate.
Loaning specimens to museums
A number of anatomy establishments have asked us whether they can loan specimens, for example to students or museums.
Licensed anatomy establishments may loan specimens, providing the DI gives permission in writing. We advise that this loan is for a defined period. We have produced a model written agreement for this purpose, which can be downloaded from our website.
Previous e-newsletters
Previous copies of the HTA's e-newsletter are available in the publications section of this website.
Subscription to HTA e-newsletter
New users can subscribe on the subscriptions page.