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Issue 58 / September 2016

HTA news Sector news
Human Application Post mortem sector Research sector Anatomy sector Organ Donation and Transplantation sector


HTA Fees Consultation

There isn't much time left to respond to the proposed changes to our licence fees structure. The consultation opened on 25 July and will remain open until 30 September.

If you have an interest in the fees structure, please do take part in the consultation. The consultation documentation, which includes the proposals and specific questions we would like answering, is available on our website.

Throughout the consultation period, we have held five webinars where we have discussed proposed changes to the sectors most affected and answered questions. Recordings of these webinars are available now on our website.

The aim of this consultation is to seek your views on the proposed changes to the fee structure, which are due to be implemented from April 2017. Actual fees for 2017/18 will be determined later in 2016, reflecting the outcome of the consultation and our budgeting process. Fees will be announced in December 2016, after approval by the HTA Board.
 

Reminder: Designated Individual and Named Contact information 

Designated Individuals and ODT named contacts both play key roles in the HTA licensing framework. 
 
It is a legal requirement that licences under the Human Tissue Act and the Q&S Regulations must have a Designated Individual to supervise licensable activities. Designated Individuals have the primary legal responsibility for ensuring:
  • suitable persons carry out licensable activity;
  • suitable practices are used in carrying out any licensed activity, and
  • the conditions of the licence are complied with.
There is no formal DI role for ODT sector licences. Instead, the named contacts play a key role in communicating regulatory requirements and planning audits.
 
It is important that you notify us without delay if the DI or named contact for your licence is no longer able to carry out their duties. For example, if the previous DI or named contact has changed roles or moved to another organisation. Failure to do so is a breach of the statutory and standard licence conditions on all licences in the Anatomy, Human Application, Post Mortem, Public Display and Research sectors. For named contacts in the ODT sector, this is a breach of the HTA’s licence Directions.
 
You can check who the Designated Individual for your licence is here.
 
If your Designated Individual is incorrect, you will need to vary your licence. For more information on licence variations and the forms required, please refer to our website
 
Designated Individuals and named contacts are also required to notify us of any changes in contact details. If you are a DI or a Named contact and your contact details have changed recently, please let us know. If you do not hold one of these roles, but are aware that the contact details for the Designated Individual or Named Contact for your licence have changed recently, please also get in touch.
 

Codes of Practice and Standards implementation

The revised Codes of Practice and Standards are due to come into force in April 2017. In preparation, we recommend that you read through the draft Codes and Standards.

We have also published the presentations from the consultation workshops last year. You may find these useful as they highlight the major changes to each Code and the associated Standards.

Please note, you may need to update your documents if you have any references to our Codes or Standards. In particular, references to Code 5: Disposal of relevant material or Code 8: Import and export of relevant material will need to changed. Codes 5 and 8 have been incorporated into sector codes.

If you have any questions about the new Codes or Standards, please contact us

Webinars
To help you prepare for implementation, we will be holding webinars in early 2017, focusing on the major changes in the new Codes and Standards. The webinars will also provide an opportunity for you to ask us questions.

If you are interested in taking part in a webinar, please register your interest here – this will help us organise the right number of webinars, in the sectors you are interested in and at the right time.

Guidance
We expect to publish additional guidance and training materials over the coming months. We’re looking for volunteers to help review materials to make sure they’re fit for purpose. If you are interested in reviewing these, please let us know.
 

UKCRC Tissue Directory has arrived

The UK Clinical Research Collaboration (UKCRC) are calling on human sample custodians to register on their new online directory.

The UKCRC Tissue Directory and Coordination Centre is a new initiative to optimise the use of existing human samples in research. To satisfy the need to locate samples, the Centre has created a Tissue Directory which will hold the information for collections across the UK. They are funded by a group of UKCRC funders (MRC, Wellcome Trust, CRUK, BHF and others), with the anticipation that the projects they award funding to make use of the Directory, as they are keen to optimise the use of existing human tissue collections and associated clinical and sample handling data whilst minimising duplication of effort. The directory launched this year following the successful registration of over 50 biobanks; you can read about the initiative here.

To register or search for samples visit biobankinguk.org. If you have any feedback or questions, please get in touch at contact@biobankinguk.org and look out for upcoming roadshows near you.
 

Sector events

Thank you to Newcastle upon Tyne Hospitals NHS Foundation Trust for hosting us in August. We were able to hear patient and public views on tissue donation for research first hand. We’ve learnt previously that the public feel more confident donating their tissues or organs where the donation and use is regulated. It was reassuring to see this is still the case for this community.

If you are organising or attending an event which is relevant to one of the sectors we regulate, please let us know. We’re particularly interested in finding out and sharing information about:
  • opportunities for professional development;
  • events which connect individuals working under HTA licences;
  • opportunities for members of the public to find out more about your sector; and
  • events which can help increase the public’s awareness of HTA’s regulatory role.
Whether the event is aimed at professionals or members of the public, please let us know.
 

HTARI and SAEARs Survey

In the July e-newsletter, we invited you to take part in a survey about the information we publish about HTA Reportable Incidents (HTARIs) and serious adverse events and reactions (SAEARs). Thank you to those who have already responded to the survey.

If you have not yet responded, we would be grateful if you could please fill in this questionnaire. Responses to this questionnaire will be anonymous and will be taken into consideration as part of our review.

We will keep the questionnaire open until Friday 7th October.
 

Human application sector news

Coding and Import update

We are continuing to work with the Department of Health (DH) on implementation of the two new EU Directives on Import and the Single European Code.  Further delays in the transposition process mean that the consultation on the draft Regulations will not begin in September as planned.  It is not currently possible to give a definitive timetable for transposition and implementation at this stage. However, please be assured that the draft Regulations will still be subject to a formal consultation process through which you will have an opportunity to comment on the approach taken.  

DH and the HTA remain committed to a proportionate approach to implementation of the Directives, and will take into account the impact of these delays on your ability to comply by 29 April 2017.

If you have any questions about the Directives, please feel free to contact us.

HTA Compliance Resource for US Imports

The HTA has a statutory responsibility to ensure the quality and safety of human tissue and cells imported into the UK for human application, the majority of which originate in the US. Regulatory requirements differ internationally, and we have identified  a number of key differences. 

With technical assistance from the FDA and AATB, the HTA has developed a guide to meeting UK regulatory requirements when tissues and cells for human application are imported from the US. The resources explain the applicable UK regulatory requirements that differ from the US requirements for human tissues and cells for human application. It also references the relevant legislation and regulations for each and suggests actions that UK-based importing tissue establishments and US-based third country supplierscan take to meet the requirements. 

The guidance can be found here

Post mortem sector

HTA's Role Advising on BBC Documentary featuring a Post Mortem examination


We have been advising a TV production company on a documentary for the BBC about the impact that obesity can have on one’s health, explaining our role as the regulator, and how best to maintain the privacy and dignity of the deceased.. The focus of the programme is on what happens inside the body, out of sight, so they have used a post-mortem examination to highlight the effect of obesity on a body’s vital organs.  The programme is available to watch on BBC iPlayer here. You can also find a 'Behind the Scenes' clip featuring an interview with our Head of Regulation, Caroline Browne here, or read a blog by Caroline on our involvement with the programme here.

Published list of Mortuaries happy to be contacted regarding

Brain and Spine removals

Following a survey we conducted last year on brain and spinal cord retrievals within establishments we licence in the post mortem sector, we have published a list of mortuaries who are happy to be contacted directly by brain banks with requests for them  to perform brain and spine removals - this is available on our website here. We have also written to all brain banks and DIs in the sector to share the results from this survey. If you are interested in this piece of work and have not had this email, please contact us.
 

Mortuary open days

If you are planning on holding an open day in your mortuary for members of the public, please let us know. Open days can help the public to understand what goes on in a mortuary, why post mortem examinations are needed and the possible benefits. We are happy to help promote your open day to encourage attendance and public understanding of the post mortem sector. We will share the details of your open day in our newsletter for the public and through social media. If you would like, we may also attend and participate in the days.

Research sector

Research sector compliance reports

In August, we published a short report of the Research sector compliance updates, collected in December 2015.

Compliance updates have been collected every two years since the first round in 2011. These updates help to maintain our oversight of regulated sectors, guide our regulatory approach and inform the scheduling of site-visit inspections.

The report presents a snapshot of selected findings from the compliance updates and provides a brief analysis of the trends and themes.

You can view the report here.

Research sector review

As we trailed in our last eNewsletter, we have now published our Research sector review, which summarises inspection findings and compliance with our licensing standards. Through the review, we also aim to share good practice and promote further improvements.

As with the compliance updates review, we hope that this report will be useful to people working in the sector as well as to members of the public who have interest in human tissue research.

HRA Stakeholder survey - Call for comments

Our colleagues at the Health Research Authority (HRA) and EQUATOR Network are conducting a project that aims to increase the transparency and completeness of future published research. The two organisations have published a survey which will help inform future HRA policies on research reporting and dissemination.

The survey focuses on how to modify the current question A51 on the IRAS ethics application, ‘How do you intend to report and disseminate the results of the study?'. The aim in changing the question is to ensure researchers understand the full extent of their commitment to responsibly share their research findings.

You can access the survey here. The survey closes at the end of September.
 

Anatomy sector

Anatomy sector compliance reports

In August, we published a short report of the Anatomy sector compliance updates, collected in December 2015.

Compliance updates have been collected every two years since the first round in 2011. These updates help to maintain our oversight of regulated sectors, guide our regulatory approach and inform the scheduling of site-visit inspections.

The report presents a snapshot of selected findings from the compliance updates and provides a brief analysis of the trends and themes.

You can view the report here.

Organ Donation and Transplantation sector

Please remember to report all Serious Adverse Events and reactions (SAEARs) within 24 hours of discovery


SAEARs in the Organ Donation and Transplantation sector must be reported to NHSBT, using the online incident submission form. This should be done as soon as possible after discovery and within the 24-hour window set out in the Quality and Safety of Organs Intended for Transplantation Regulations 2012.

For more information on SAEARs, including on how to report them, please refer to our website.

This information contains definitions for both serious adverse events and reactions. If you are unsure whether to report an incident, please contact us or NHSBT. 
 
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