Issue 18 - August 2009
Welcome to the August 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 more than 5,000 subscribers.
This issue reports back on our review of the year event on 14 July, where we held a debate on cord blood banking. You can also find out about the Hampton Implementation Review of the HTA.
Read on for updates for the human application sector on relevant material and the EU coding system. For the post mortem sector we provide new guidance on temporary body storage in a pandemic situation. This issue also provides lots of guidance for the research sector - on ethical approval and licensing, research tissue banks and diagnostic archives.
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.
HTA review of the year event
120 people attended our review of the year event on 14 July in London. As well as hearing about the HTA's achievements and activities over the last year, the audience shared ideas about HTA strategy and participated in a lively interactive panel debate on cord blood banking. To find out more about what happened, visit our website where you can download presentations from the speakers and read about the debate.
The discussion on cord blood was well received by attendees with 90% agreeing that the discussion was interesting and engaging.
More information about cord blood is available on our website. The Genetics Interest Group will shortly be publishing a leaflet on options for cord blood banking and we will link to it from our website.
Annual Review
We recently published our 2008/09 Annual Review ‘Demonstrating Value'. The Annual Review describes our achievements and activities over the last year and we hope it captures how we continue to work with the people we regulate.
The Annual Review and our full Annual Report and Accounts are available on our website. If you would like to receive a hard copyof the review, please contact fiona.mckinson@hta.gov.uk.
New report finds the HTA is risk-based, proportionate and transparent
The Better Regulation Executive, a part of the Department for Business, Innovation and Skills (BIS), published its report of the Hampton Implementation Review of the HTA on 23 July. The review praised the HTA for using the principles of Better Regulation to ensure we are risk-based, proportionate and transparent. The review team rated the HTA highly on provision of advice and guidance and minimisation of inspections and data collection burdens. The review also found that the HTA has done a lot to keep costs of regulation to a minimum.
Further information can be found in the HTA media release or in the full Hampton Implementation Review report on the Department for Business, Innovation and Skills website. Tim Courtney of the Better Regulation Executive delivered a presentation with Dr Sandy Mather, HTA Director of Regulation on the report at our review of the year event.
Revised codes of practice
The revised codes of practice have now received parliamentary approval. The revised versions, and an entirely new code on research, will come into force via HTA Directions on 15 September 2009. They will replace all of the previous codes, except the Import and Export code, which was published in May 2007. To help stakeholders to prepare for their introduction, the revised codes are available on the HTA website. We have also prepared a rationale document summarising the consultation comments and explaining the changes we have made.
Licence fees
We held three workshops in June so that we could listen and take on board the views of the licensed sectors about licence fees. The workshops were regarded by stakeholders as a very welcome opportunity to understand our regulatory remit, the substantial amount of hidden activity that licensing requires and what resources are needed to carry out this work. One of the key messages we took away was that we needed to explain in much more detail what regulatory activities the licence fees covered. Adrian McNeil's presentation at our review of the year event and our 2008/09 Annual Review give more information on the percentage of time we spend on regulatory activity.
We will provide more information about licence fees in future issues of the e-newsletter.
Upcoming events
Public Authority meeting - 24 September
The HTA holds two Authority meetings in public every year. The next public meeting will be held on Thursday 24 September in London.
This event provides an opportunity to observe the Authority as it discusses its business and join the members and executive team for lunch. There will also be an opportunity to ask questions. Places at the meeting are limited and will be allocated on a first-come, first-served basis. If you would like to attend, please register by Monday 7 September.
Once your place at the meeting has been reserved, you will be sent a confirmation letter and agenda at the beginning of September. The papers for the meeting will be available to download from our website one week before the meeting.
Post mortem sector conference - 21 October
An HTA conference in the autumn will unite professionals working in the post mortem sector, including pathologists, anatomical pathology technologists (APTs) and coroners.
The conference, ‘Working together, building confidence', will take place on 21 October in London. It is targeted at DIs and Persons Designated working at HTA-licensed establishments, and representatives of relevant professional bodies.
After three years of licensing and inspection, the HTA has developed a detailed understanding of the challenges facing the post mortem sector. We now hope to support DIs in understanding and fulfilling their statutory responsibilities under the Human Tissue Act and will encourage delegates at the conference to explore possibilities for improvement.
Coinciding with the launch of the HTA's 2009 report of compliance in the sector, the conference will provide the opportunity for collaboration between professional groups. Presentations will include: consent under the Human Tissue Act, the changing role of the APT, a pathologist's perspective on how professional bodies can work together to improve standards, and a session on coroners' reform by the Ministry of Justice.
A choice of interactive seminars will be available in the afternoon, including the role of the DI, forensic post mortems, managing untoward incidents and communication issues surrounding disposal.
The conference has proven to be very popular and registration is now closed, although there is a reserve list, which you can find out how to join on our website.
Independent Assessor conference - 4 November
On 4 November 2009, we will be holding our third Independent Assessor (IA) conference in London. IAs and members of transplant units have been invited to the event. For more information, please contact transplants@hta.gov.uk
Membership of the Authority
The Authority is considering a succession planning exercise to ensure its composition meets the long-term requirements of the HTA. This includes how the Authority can access professional expertise from the sectors we regulate. We will share our conclusions with the Department of Health, who will work with the Appointments Commission to recruit Members for April 2010. All appointments to the Authority are made by the Secretary of State for Health.
Licensing and inspections update
Since the HTA began licensing in 2006, we have completed 675 phase one (desk-based) inspections and 293 phase two (site-visit) inspections across our five licensed sectors. Inspections are usually scheduled according to assessed risk; however they may also be scheduled randomly or on a reactive basis following receipt of information.
Significant regulatory action
A report on significant regulatory action taken by the HTA in the first quarter of the business year (1 April to 30 June) was submitted to the Authority at its July meeting. Summary compliance reports for all our licensed sectors will be published in October.
Notice for Designated Individuals
As we are in the holiday season, we would like to give licensed establishments some information about what contingencies should be in place when DIs go on annual leave. Although DIs have overall responsibility for the licence, as a general principle, we do not expect them to supervise activities on a daily basis.
We therefore expect DIs to implement year-round systems and processes to ensure that licensable activities are suitable and conducted by suitable people. Before going on holiday, DIs must validate the robustness of these systems and processes and ensure that one or more Person Designated has delegated responsibility in their absence.
If a DI is out of the office for a prolonged period of time, for example, on long-term sick leave or maternity leave, the HTA must be informed; in most cases by the Licence Holder or the corporate Licence Holder. We can then advise what actions should be taken. You can contact us at: licensing.enquiries@hta.gov.uk.
Information for the human application sector
Relevant material under the Quality and Safety Regulations
To provide additional guidance for the human application sector, we have recently published a supplementary list of tissues and cells that have been identified as falling within the remit of the Human Tissue (Quality & Safety for Human Application) Regulations 2007 (Q&S Regulations). This list complements the supplementary list of materials for the purposes of the Human Tissue Act 2004.
FAQs on serious adverse events and serious adverse reactions
Under the Q&S Regulations, licensed premises are required to record and submit notifications of any serious adverse events / reactions that occur. These notifications then need to be followed up by the submission of a report, documenting the outcomes of local investigations into the incident.
The HTA is required to investigate and register information about serious adverse events and reactions, and communicate information about incidents as necessary. This communication allows appropriate action to be taken if tissues or cells need to be withdrawn, or control measures implemented.
To provide additional guidance for the human application sector, we have recently published frequently asked questions (FAQs) on our website about serious adverse events and serious adverse reactions.
Serology testing of autologous donors
It is a requirement of the Q & S Regulations that donor serum testing must be performed when tissues or cells are stored or cultured for more than 48 hours.
We have recently completed a policy review related to consent and testing implications for establishments that carry out autologous transplants of tissues and cells on adults and children. Our website provides a position statement on testing requirements for the following two scenarios:
- when a patient is not competent to consent to testing at the time of the medical procedur
- when a patient is competent to consent to testing but the clinician deems it inappropriate to ask for consent to test.
Update on the European coding system
The European Commission has advised that the European coding system be delayed while the Directorate General for Health and Consumer Affairs (DG Sanco) carries out a comprehensive Regulatory Impact Assessment of the system. There will be a full public consultation on the Regulatory Impact Assessment before the outcome is published in 2010.
HTA Directions 002/2007 state that human application establishments undertaking procurement, testing, processing, storage, distribution and import / export of tissues or cells for human application, shall ensure that a single European identifying code is allocated to all donated material at the establishment. A European Commission project commenced in 2006 and the final report was presented to the Competent Authorities' meeting in 2008. The European Standardisation Committee developed a proposal that there should be a high level code which includes the country identification and tissue establishment number so that material could be traced from country to country.
The HTA will issue further guidance when the detailed requirements of the European Coding System are clarified by the European Commission. For further information on the European coding system including background, implications and timescales, please see our website.
MHRA draft guidance on Advanced Therapy Medicinal Products
On 15 July, the Medicines and Healthcare products Regulatory Agency (MHRA) published its draft guidance on the proposed UK exemption scheme for Advanced Therapy Medicinal Products (ATMPs) which will apply from the autumn. It is keen to ensure that the guidance is fit-for-purpose and covers as many relevant issues as possible. The MHRA is therefore inviting comments on the documentation up until 18 September 2009. Please send any comments you may have to Caroline Brennan at the MHRA: caroline.brennan@mhra.gsi.gov.uk.
The HTA issued a joint statement with the MHRA on the relationship between the ATMP Regulation 2007 and the Quality and Safety Regulations, in March 2008. The statement aims to clarify when treatments involving tissues and cells are regulated by the MHRA, and when they are regulated by the HTA. You can find frequently asked questions and definitions of the key terms related to the ATMP Regulation on our website.
Information for the research sector
Licensing requirements for research tissue banks with generic ethics approval
NHS Research Ethics Committees (RECs) may give generic ethics approval for research tissue banks, providing they are stored on HTA-licensed premises. These banks are then required to operate under the terms and conditions agreed with the REC. This means that a specified remit of work is permitted without the need for further individual project-specific approvals.
If you have not done so already, those working at HTA-licensed establishments need to inform us if the establishment also houses a REC-approved research tissue bank storing relevant material. To do this, please email Lucy Atwal: lucy.atwal@hta.gov.uk with your licence number, tissue bank REC approval reference number and where on the premises the bank resides.
The National Research Ethics Service (NRES) recommends that research tissue banks apply to specific flagged RECs to obtain generic approval, although any REC may consider an application.
More information is available in the joint position statement between the HTA and NRES (see ethical approval section).
Licensing requirements for tissue held with project-specific ethics approval
The HTA has been made aware of some instances where the legal requirements of the Human Tissue Act 2004 (HT Act) as well as the governance arrangements for NHS Research Ethics Committees (GAfREC), have been over-interpreted. Where this is happening, it can lead to unnecessary stringency in the way research on human tissue is governed.
Tissue held for a specific project that has gained REC approval does not need to be stored on HTA-licensed premises. Conversely, tissue held for a project approved by a committee that is not an NHS REC (e.g. a university ethics committee) must be stored on HTA-licensed premises.
Although it is good practice for NHS REC approval to be in place, it is not a legal requirement that a project approved by a university ethics committee also needs to gain NHS REC approval.
More information on licensing and consent requirements of the HT Act is available in the new code of practice on Research. If you would like more information, contact Christiane Niederlaender: christiane.niederlaender@hta.gov.uk. If you would like more information about the requirements of GAfREC or the NRES standard operating procedures, email queries@nres.npsa.nhs.uk.
Licensing requirements for diagnostic archives used as research tissue banks
Tissue taken from the living for diagnosis and subsequently stored in a diagnostic archive can be a valuable research resource. Purely diagnostic archives do not need to be stored on HTA-licensed premises. However, the HT Act clearly requires that storage of tissue for scheduled purposes, including research, must take place on licensed premises. Where a diagnostic archive functions as a resource for researchers as it invites applications for the release of samples, or in any way advertises the archive as a research resource, it is functioning as a research tissue bank. It must therefore fall within the HTA's licensing framework.
The HTA and NRES have developed a joint position statement that sets out licensing, ethical approval and consent requirements and options.
Use of human tissue xenografts in research
Human tissue xenografts - human cells, tissue or organs transplanted into another species - are used during the course of research in connection with disorders, or the functioning, of the human body. A policy on the use of human tissue xenografts is available on our website. It includes information about the licensing and consent requirements.
New web page: how to donate tissue for research
We have recently published a new page on our website which describes how human tissue is used in scientific and medical research and the role of the HTA in the donation of tissue for this purpose. We hope that the web page will provide guidance for anyone who wants to find out more about donating their tissue for research.
Evaluation of the impact of legislation and HTA regulation on research
At the end of 2008 the HTA commissioned Opinion Leader to conduct an evaluation of how human tissue legislation and its required regulation by the HTA has affected researchers working with human tissue. The purpose of the evaluation was to review performance against one of the HTA's key objectives - to not hold up tissue-based research.
We chose to work with an external consultancy on this project to ensure that the results were independent. We selected Opinion Leader because they had an in-depth understanding of our regulation of the research sector having worked with us on our codes of practice consultation. Opinion Leader also has significant experience of undertaking evaluation projects in this area.
Opinion Leader carried out the evaluation between January and April 2009. 295 people took part via telephone and online interviews. The report from the evaluation will be published on our website in September.
NCRI launches template for access policy development
The National Cancer Research Institute (NCRI), in collaboration with the National Cancer Intelligence Network and onCore UK, has launched a template to assist the custodians of research data or biological samples in developing access policies for their collections. The document contains example terms for an access policy and associated materials transfer agreement. These may be adopted directly by organisations or adapted to their specific needs.
The template will help to ensure that access policies are legal, ethical and effective. By allowing more effective sharing of resources it aims to reduce unnecessary duplication of data and sample collection.
The NCRI is looking for organisations to pilot use of the template and give feedback on it, so that it can be improved in the light of experience. Both the template itself and the summary of the consultation responses can be accessed on the NCRI website.
Information for the post mortem sector
New web page: guidance on temporary body storage
To help prepare for a pandemic situation, the HTA has produced guidance on temporary body storage arrangements and licensing requirements.
A pandemic is an epidemic of infectious disease that spreads through human populations across a large region; for instance a continent, or even worldwide. Pandemics can cause high levels of mortality.
The HTA has been working with the Home Office and others to develop a policy and system for the provision of a licence in the event of a mass fatality incident resulting in the need for an emergency temporary mortuary.
The new web page explains the situations in which temporary facilities for storing bodies are subject to licensing.
Information for the organ and bone marrow transplant sector
Organ donations from living people
From 1 April 2009 to 24 July 2009, 334 reports from Independent Assessors (IAs) were submitted to the HTA, 330 of which were approved. One case is currently awaiting more information before it can be adequately assessed and three cases have been referred to an HTA panel for decision. Since 1 April 2009, 12 cases have been referred to a panel for decision.
Bone marrow donations from children and incapacitated adults
From 1 April 2009 to 24 July 2009, 24 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which were approved.
Revised Guidance for transplant teams and Independent Assessors
The HTA has revised the Guidance for transplant teams and Independent Assessors. The guidance was last reviewed and published in 2007. It has now been updated to reflect the changes in the revised code of practice on the donation of solid organs for transplantation, which will be published in September. It has also been expanded to incorporate guidance on areas which generate most enquiries, such as requirements for documentary evidence of relationships. For more information email: transplants@hta.gov.uk
Recent media stories about human tissue
On 24 June, the HTA issued a media release on the number of altruistic kidney donors we have approved. We received a large number of media enquiries on this issue. The media release was covered by the national media - Press Association, the Independent, BBC, Daily Mail, Guardian, The Mirror, Channel 4 News, ITV - as well as specialist media, online and regional publications. The new figures show an increase in the number of people donating to someone they do not know; 15 people were approved to donate in 2008/09 compared with 10 in 2007/08.
The role of the HTA was described in coverage of the announcement of a UK-wide Brain Bank Network led by the Medical Research Council. The network will coordinate the 12 major brain banks in the UK, from London to Edinburgh. The HTA contributed to the Imperial College Brain Bank story, which featured on the BBC News website and on the Today programme.
Previous e-newsletters
Previous copies of the HTA's e-newsletter are available in the news and events section of our website.
Subscription to HTA e-newsletter
New users can subscribe to the e-newsletter online.
To unsubscribe, log in and select 'no' to receiving email updates. If you have any problems unsubscribing please email website@hta.gov.uk