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Issue 6: July 2007

Welcome to the July issue of the Human Tissue Authority's e-newsletter which provides updates for all the sectors we regulate. In this issue we provide advice for the post mortem sector on the licensing of emergency mortuaries, and clarification for the research sector on exemptions to licensing. You can also find out how to register to attend our next public Authority meeting and annual report-back meeting.

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

Stem cell FAQs

We have recently published a series of frequently asked questions about the regulation of stem cell lines, which now come under the EU Tissues and Cells Directive and the HTA's licensing arrangements when used for human application.

Code of Practice on the import and export of bodies, body parts and tissue

In June we published the final version of our Code of Practice on the import and export of bodies, body parts and tissue. The Code provides practical guidelines for establishments licensed under the Human Tissue Act and EU Tissues and Cells Directive; and establishments that do not undertake licensable activities but are involved in import and / or export of human tissue. Thank you to everyone who took part in the consultation on the Code.

HTA public Authority and report-back meetings, 6 September 2007

The HTA is holding its next public Authority meeting on the morning of Thursday 6 September 2007 in London. This is an opportunity for people to observe the Authority discussing its business.

The HTA is holding its annual report-back meeting on the afternoon of Thursday 6 September 2007 at the same venue. We will launch our Annual Report at the meeting and review the HTA's work in the year since the Human Tissue Act fully came into force. We will also announce the results of a project that we are working on with Ipsos MORI to evaluate public and professional opinions about the work of the HTA.

If you would like to attend the public Authority and report-back meetings please register on this website by 23 August 2007.

Update on recent media stories about human tissue

Anatomy schools report more enquiries from potential donors

Data provided to the HTA by medical schools has shown that publicity is prompting people to bequeath their bodies to medical science.

HTA media release 'People sign up to leave their bodies to medical science'

Media coverage included:

BBC (2007) Rise in bodies for medic training, BBC, 19 July 2007

Presumed consent in organ donation

The Chief Medical Officer, Sir Liam Donaldson, recently proposed in his Annual Report that a system of presumed consent for organ donation should be introduced.

HTA media release 'Statement on Chief Medical Officer's announcement'

Articles on this issue included:

Laurance, J. (2007) The Big Question: Should organ donation be automatic or a matter of personal choice? The Independent, 18 July 2007

Hawkes, N. (2007) System is not the magic solution, The Times, 18 July 2007

HTA Authority member Keith Rigg appeared on BBC TV.

Adult to adult liver donation

On 2 July, the media reported the first NHS adult to adult liver donation from a living donor. This and all other living organ donations are now regulated by the HTA to ensure that informed consent has been given, there is no coercion or payment, and the risks are explained.  Articles included:

Guardian (2007) First NHS live liver transplant, The Guardian, 2 July 2007.

Advice and guidance for licensed sectors: consent standards

We are currently researching the compliance by licensed establishments with our standards on consent. A report of our findings will be published on our website at the end of August. This will identify trends across the sectors and highlight areas of good, as well as not so good, compliance. A follow-up publication is planned for later in the year offering practical advice and guidance on how to tackle difficult issues, and improve overall compliance with the consent standards.

Tissue used for human application

Human Tissue (Quality and Safety for Human Application) Regulations 2007

The Human Tissue (Quality and Safety for Human Application) Regulations 2007 came into force on 5 July 2007. These Regulations implement the full requirements of the EU Tissues and Cells Directive (EUTCD).

More information about the Quality and Safety Regulations

If you had an HTA licence to store material for human application before 5 July 2007, you are automatically considered to be licensed by the HTA and should have received a communication from us about the changes to your licence.

If you did not have an HTA licence before this date, and you require one, you will need to contact the Head of Regulation for your area urgently. 

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 have now published a new set of Directions (002/2007) which summarise the requirements of the Human Tissue (Quality and Safety for Human Application) Regulations and the second technical directive of the EUTCD.

As explained in an email sent to all human application establishments on 29 June 2007, the new Directions require establishments to complete a self-assessment form assessing compliance against HTA standards. This must be completed every 6 - 12 months or earlier if required by the HTA, and also prior to an inspection by the HTA.

Establishments must complete the first self-assessment form by 1 September 2007. The form can be downloaded on this website.  Establishments should download and print the form, and work on a paper copy. (Please note: the online application form should be completed by new applicants only). Completed self-assessment forms must be retained, supplied to the HTA on request, and made available to a duly authorised person or persons from the HTA at any inspection of the premises.

Information for the post mortem sector

Licensing of emergency mortuary facilities in mass fatality situations

We have recently published a policy on the licensing of emergency mortuaries. This is the result of collaboration between the HTA, the Home Office and the Police, and is based on a support system of advice and guidance linked to the requirements of the Human Tissue Act 2004. Information about the legal framework, the preparations that can be made now by emergency planning teams, and the actions that would be taken by the HTA should an event resulting in mass fatalities occur, is available on our website.

Model consent form

We have now published a model consent form which provides a suggested format for Trusts taking consent for post mortem examination of adults, under the requirements of the Human Tissue Act 2004. The form may also be used for older paediatric cases, but is not recommended for babies and obstetric losses.

This is a model form based on the HTA Code of Practice on Consent and the requirements of the HT Act. Organisations are not obliged to use the HTA form but have a statutory requirement to comply with the consent requirements of the Code and the HT Act. Organisations can adapt the form for local use.

Information for the research sector

Clarification on exemptions to licensing of tissue from living people

An HTA licence is not required if human tissue is stored for a specific research project which has ethics committee approval or is pending approval.

If researchers wish to retain tissue for future, unspecified research, then a licence under the HT Act will be required. Applications for a licence should be made in good time: we recommend at least three months before the current research project ends. Alternatively, an application for ethical approval for the new research project should be made in good time to coincide with the end of the current research project.

The samples will need to be transferred to an existing licensed store until either a licence is granted or ethical approval has been obtained. Human tissue is an invaluable resource for research, and disposal should be a last resort.

Most research institutions and NHS establishments have a licence from the HTA so researchers should be able to transfer human tissue to a licensed store in their own organisation.

List of research establishments licensed by the HTA

Clarification on the status of human tissue collected for diagnosis

Whether the storage of tissue is licensable under the HT Act depends on the primary purpose for which the tissue is taken and stored.

If the primary purpose for taking the tissue is for diagnostic purposes, then storage of that tissue is not licensable under the HT Act. 

If the primary purpose for taking and storing tissue is for research, then storage of the tissue is licensable under the HT Act. Tissue stored for research that does not have Research Ethics Committee (REC) approval must be stored under a licence granted by the HTA.

Practical guidance about how to apply this policy, and further information about the status of human tissue banks and what constitutes ethical approval, is available on our website.

UK Clinical Research Collaboration regulatory and governance advice service

The UK Clinical Research Collaboration (UKCRC) has established a regulatory and governance advice service to provide practical help with the legislative and good practice requirements that govern clinical research in the UK. The service supports local advice providers, such as NHS R&D and university R&D offices, to provide consistent and authoritative advice to their research communities.

The new advice service is supported by the HTA in partnership with a number of other regulatory and governance bodies. Further information on the service is available on the UKCRC website.

Living-donor transplants update

Organ donations

From 1 September 2006 to 9 July 2007, 606 reports from Independent Assessors (IAs) were submitted to the HTA, 592 of which have been approved. Two cases have not been approved and 12 cases are awaiting more information before they can be adequately assessed.  To date, eight cases have been referred to a panel of HTA members for a decision.

The HTA is organising a conference for IAs on 23 October 2007.  The purpose of the conference is to review the HTA's first year of regulating living organ donation and to thank all IAs for the part they have played in making it such a success. If you are an IA and would like to register, please email transplants@hta.gov.uk

IA e-learning package

The e-learning package for IAs will be launched soon. We will contact IAs once the system is available. The package has been designed to train IAs who have not attended an HTA training day, and will also be used as part of the reaccreditation process. It is also possible to access this package if you would like to refresh your memory of the approval process.

Thank you to those IAs who took part in user-testing - your feedback was greatly appreciated and has been incorporated into the final version of the system.

Bone marrow transplants

From 1 September 2006 to 9 July 2007, 83 reports from Accredited Assessors were submitted to the HTA, all of which have been approved.

In March 2007, we published a leaflet providing information for people who are considering donating bone marrow or peripheral blood stem cells. This leaflet explains the role of the HTA in the assessment process. We have recently translated the text into Arabic. Download this and our other translations.

If you would like to order printed copies of the English version, please email sarah.beyer@hta.gov.uk

Department of Health Ministers

The Department of Health has recently announced the areas of responsibility for its new Ministerial team. The Ministers, led by the Rt Hon Alan Johnson MP as Secretary of State, include Ivan Lewis MP, Professor Lord Darzi KBE, Anne Keen MP and the Rt Hon Dawn Primarolo MP.

The HTA's work falls under the remit of Dawn Primarolo.

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