Issue 9 February 2008
Welcome to the February issue of the Human Tissue Authority’s e-newsletter which provides updates for all the sectors we regulate.
This issue includes information about the recent publication of the Organs for Transplants report and the further work of the Organ Donation Taskforce which is now going on to look at the issue of presumed consent.
In this issue we also give an update on the revision of our Codes of Practice and guidance on public display. We are holding two key HTA events next month – a public Authority meeting in Cardiff and a conference on regulating tissues and cells for the human application sector. Read on for information about how to register for these events.
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
Publication of the Organ Donation Taskforce report
The Organ Donation Taskforce, chaired by Elisabeth Buggins, was established by Alan Johnson, the Secretary of State for Health in 2006 to identify barriers to organ donation and recommend ways of increasing organ donation within the current legal framework. The Taskforce's report ‘Organs for Transplants’ was published on 16 January 2008.
The HTA has issued a statement welcoming the recommendations in the report, which have the potential to make a huge impact on organ donation rates in the UK. Download the report and read our statement on this website.
Alan Johnson has asked the taskforce, of which Shirley Harrison, the Chair of the HTA is now a member, to consider the case for introducing presumed consent. Through Shirley, the HTA will contribute their substantial experience of implementing the consent provisions of the Human Tissue Act and of regulating organ donations from the living.
Recent media stories about human tissue
Altruistic kidney donation
The HTA recently held a press conference in which Barbara Ryder, an altruistic kidney donor, met Andy Loudon, the recipient of her kidney. Altruistic non-directed donation is one of the new forms of donation now permitted by the HTA. We have introduced new systems to provide flexibility in who can donate to whom, whilst ensuring key ethical principles are maintained. This is where a living person may be allowed to donate a kidney to a stranger. This historic first ever meeting of its kind was made possible due to the fact that both parties had agreed to talk about their experience of living-donor transplants.
A selection of media coverage from the event and the HTA’s press release is available on this website.
You can also find out more about altruistic donation on this website.
Codes of Practice update
We are currently updating our first six Codes of Practice and public display guidance, and developing a new Code on research. These take into account comments from our stakeholders, policy developments at the HTA and our experience of regulation.
The list of updated Codes of Practice will be as follows:
- Consent
- Donation of organs for transplantation
- Post mortem
- Anatomical examination
- Disposal of human tissue
- Donation of allogeneic bone marrow and peripheral blood stem cells for transplantation
- Public display
- Research
We plan to issue these Codes for public consultation in summer 2008.
Public Authority meeting – 18 March 2008
The HTA holds two Authority meetings in public every year, one of which takes place outside London. The next public Authority meeting will be held on Tuesday 18 March in Cardiff.
This meeting provides an opportunity to observe the Authority discussing its business and there will also be an opportunity for you to put questions directly to the Authority. On this occasion, the meeting will provide an opportunity for our stakeholders, including those in Wales and surrounding areas to engage with the Authority.
If you would like to attend the meeting, please register by clicking here.
Dates of future Authority meetings and minutes from past meetings are also available on this website
Information for the human application sector
Laboratory tests required for donors
The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (the Regulations 2007) transposed the detailed requirements of the EU Tissue and Cells Directive (EUTCD) into UK law in July 2007.
These regulations are supplemented by HTA Directions 001/2006, 002/2007 and 004/2007. Directions 001/2006 provide details of which biological tests must be performed on donors.
In the case of Hepatitis B, establishments which are licensed for human application should ensure that both the Hepatitis B surface antigen test (HBsAg) and the anti-Hepatitis B core antigen test (anti HBc) are conducted on all donors of tissues and cells for human application. The EUTCD and Directions also state what should be done if the two tests are not in agreement.
If you would like further information about these testing requirements, please contact Dr Christopher Perrett, Regulation Manager, on 020 7211 3453 or email chris.perrett@hta.gov.uk
Regulating tissue and cells for human application: the past, the present, the future conference – 25 March 2008.
On 25 March 2008 we will be holding a conference for the human application sector. Invitations have been issued to all Designated Individuals and Licence Holders in this sector and we have received an excellent response.
The conference will provide a valuable opportunity to discuss the requirements of the Regulations 2007 in more detail and to network with other licensed establishments and representatives from the European Commission. The day will consist of a series of presentations and breakout seminars that will consider past, present and future issues of relevance to this diverse sector.
Places at the conference are limited and so if you would like to attend please register on this website.
Umbilical cord blood methods development workshop
On 12 December 2007 we held a consultation workshop which brought together key stakeholders from commercial and non-commercial establishments in the umbilical cord blood banking sector. The focus was on cord blood procurement, which became a licensable activity with the implementation of the Regulations 2007. A summary of the workshop is available on this website.
Information for the anatomy sector
Changes to the model consent for body donation
Our model consent form has been revised to make it more suitable for modification by anatomy establishments and to more accurately reflect the terminology used in the Human Tissue Act. The revised model consent form still includes an option for donors to consent to the use of images, but now also references a footnote which sets out the HTA's position in relation to this issue. The revised form is available on this website.
Please note, you do not need to seek consent using the amended form where the old consent form has already been signed. You can simply begin to use the revised consent form from now on.
Information for the research sector
A new Integrated Research Application System (IRAS) was launched for use and consultation on 29 January 2008. This is a collaboration between research review bodies (including NHS R&D Offices, National Research Ethics Service and NHS / HSC research ethics committees, MHRA and others) and other organisations such as the United Kingdom Clinical Research Collaboration and the UK Health Departments. IRAS aims to streamline the process of research study approval, so researchers can submit the information that is needed by review bodes through a single portal.
You are not able to apply for a HTA licence through IRAS because we license establishments rather than research projects, and the information we collect is substantially different.
Inspections update
Since the HTA began licensing in April 2006, we have completed 535 phase one (desk-based) inspections and 104 phase two (site visit) inspections across all five licensed sectors. A further 27 phase two inspections are scheduled between now and the end of March 2007. Inspections are usually scheduled according to assessed risk; however they may also be scheduled randomly or on a reactive basis following receipt of information.
Launch of e-learning course for Designated Individuals
We are pleased to announce the launch of our e-learning course for Designated Individuals (DIs). This has been designed to train DIs on the core knowledge required to carry out their statutory duties under the Human Tissue Act. The course is primarily aimed at DIs but it can also benefit others associated with a licence. For example, Licence Holders and Persons Designated can complete the course if they wish. You can access the course on this website.
The e-learning course has been awarded four CPD credits for members of the Institute of Biomedical Science. There is also a self-accreditation scheme at the rate of one CPD credit per hour for members of the Royal College of Pathologists.
Information for the organ and bone marrow transplants sectors
Organ donations
From 1 April 2007 to 22 January 2008, 786 reports from IAs were submitted to the HTA, 785 of which were approved. One case is currently awaiting more information before it can be adequately assessed. Since 1 April, 17 cases have been referred to a panel of HTA members for a decision. Further information can be found in our Independent Assessor bulletin.
Bone marrow transplants
From 1 April 2007 to 22 January 2008, 56 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which have been approved. Further information can be found in our Accredited Assessor bulletin.
HTA evidence to the Select Committee on the EU inquiry into organ donation
Following submission of written evidence to the Select Committee on the European Union’s inquiry into ‘Communication on organ donation and transplantation: policy actions at EU level’, the HTA has now been asked to provide oral evidence to the Committee. Peter Lemmey, Director of Policy, will be giving evidence to the Committee on Thursday 13 March 2008.
Consultation on the UK Health Departments’ Code of Practice on genetic paternity testing services.
Since 2001 best practice in relation to UK DNA paternity testing services has been set out in a voluntary Code of Practice, which lays down agreed, acceptable standards for paternity testing services offered directly to the public. The Department of Health is currently consulting on a revised Code of Practice which reflects changes in the genetic paternity testing market and the legislation governing genetic testing. You can find out more about the consultation on the Department of Health website. Consultation responses should be emailed to: pt_guidance@dh.gsi.gov.uk
Job opportunities at the HTA
We currently have vacancies for the following positions: Regulation Manager. Information about these vacancies, including how to apply, is available on our website.
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