Opt-out organ donation system in England

In her closing conference speech on Wednesday 4 October, the Prime Minister announced the Government’s intention to launch a public consultation on increasing rates of deceased organ donation in England.

The consultation will focus on a new approach to deceased organ donation in England, where every person would be deemed to have given consent unless they choose to opt out. The Department of Health will run the consultation, which is planned to start in December 2017.

HTA Compliance updates 2017

Thank you to all establishments licensed under the Human Tissue Act 2004 and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 for submitting your compliance updates. 

A preliminary review of the feedback indicates that the majority of establishments found the portal and the submission process to be user-friendly. We will do an in-depth review of the feedback and all suggestions will be considered as part of our commitment and focus on continuous improvement.

The compliance update information will be used to improve our licensing records, prioritise inspections and inform our approach in each sector. Following our analysis of the data, we will consider how best to reflect any emerging trends or useful learning points.

     
The HTA has launched public guides to our Codes of Practice

We recently published guides for the public to the new Codes of Practice.

The aim of the guides is to set out the basic rights a person has when dealing with an establishment regulated by the HTA. This includes who can give consent for different activities, a person’s rights to information, and their options for how tissue is disposed of. The guides also explain how we regulate human tissue and organs in England, Northern Ireland and Wales.

This is the first time the HTA has published information on the Codes of Practice for members of the public. Previously, the HTA’s regulatory information, including the Codes, has focused on giving professionals practical guidance on human tissue legislation. We hope that publishing these guides will help make the rules around using and storing human tissue accessible to everyone.

We worked with the HTA Public Panel, HTA staff, and other external stakeholders to ensure these guides are easy to understand, and we will continue to work with others to improve our public facing guidance.

There are eight guides in total, which cover human tissue legislation, the HTA’s guiding principles, and the use of human tissue, organ, and bodies for the following specific activities:

• Donation of organs and tissue for transplantation
• Post-mortem examinations
• Research
• Anatomical examination
• Bone marrow and peripheral blood stem cell donation
• Public Display

Codes of Practice post-implementation review survey

Thank you to those of you who shared your views on our revised Codes of Practice and Standards.

We emailed establishments a survey last month to seek feedback on the updated Codes. The results from the survey will help us to learn from the implementation of the updated Codes and Standards in order to inform and improve future work.

We are working through your responses and will share a summary of these in due course.

     
General Data Protection Regulation (GDPR)

The consent requirements of the GDPR relate to the collection and processing of personal data - this is not an area regulated by the HTA.

Licensed establishments should, in the first instance, contact the data privacy professionals at their organisation for advice.

The Information Commissioner’s Office have also issued guidance to assist organisations with their GDPR preparations.

You may also find the preparation guidance for GDPR issued by the Medical Research Council of some use, as this has been written as a guide for Research Governance Managers.

Upcoming HTA website and engagement surveys

The HTA engagement survey

The HTA is looking at how we can engage with both our professional and public users better. As our professional users, we want to hear from you about how we’re doing and where we can improve. From 27 November, there will be a survey on the HTA website asking your thoughts which should take no more than 10 minutes to complete. We hope to hear from you!

The HTA website survey

We’re currently undertaking a review of the HTA website to make sure it fits your needs and that you can find all the information that you need quickly. We would appreciate your thoughts on how we can improve our website through a survey which will be available on the website from mid-December.

    
See our latest inspection reports 

The HTA has made it easier for you to see our latest inspection reports.

While each individual HTA establishment page shows the recent reports for that establishment, there is a new page on the website that shows reports for all establishments in one place, with the most recent inspections at the top of the list.

This feature should make it easier to keep up with the work of the HTA and find the latest HTA report for a licensed establishment, or across a particular sector.

You are able to sort and filter the results by sector or inspection date, and download all the most recent reports in one convenient file.

See our latest inspection reports here.

Coding and import update

Chikungunya Virus: guidance for establishments

The European Centre for Disease Prevention and Control (ECDC) produced a rapid risk assessment concerning the clusters of autochthonous chikungunya cases in Italy (Anzio and Rome). The risk assessment recommended that measures should be taken to prevent the transmission of chikungunya through substances of human origin.

Establishments in the human application and organ donation and transplantation sectors should review their donor selection procedures accordingly.

Up to date information on chikungunya and a copy of the risk assessment can be found on the ECDC website.

The first update of the Chikungunya in Italy Risk Assessment has been published by ECDC and can be found here.

Donors of tissues and cells and organs must be excluded from donating where there is evidence of risk factors for transmissible diseases on the basis of a risk assessment, taking into consideration donor travel and exposure history and local infectious disease prevalence.

We recommend that establishments should follow the advice provided by the advisory bodies relevant to the sector in which they operate.

JPAC Guidance

The Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC) have updated the Geographical Disease Risk Index (GDRI) entry for Italy. The JPAC donor selection guidelines and associated exclusions for tropical viruses, including chikungunya virus, therefore currently apply to donors who have visited Rome and the surrounding region of Lazio, including the Vatican City, Anzio and Latina.

Brain and spinal cord retrieval for research report

The HTA regulates establishments in England, Wales and Northern Ireland that store bodies prior to post-mortem (PM) examination, conduct PM examinations and remove tissue samples from the deceased, for example for use in research.

Removal of tissue from the deceased must take place on premises licensed for this activity by the HTA. The HTA licenses around 175 establishments for the removal of tissue. These include public mortuaries managed by Councils and hospital mortuaries within NHS Trusts.

In July 2016, we published a report on feedback we received from licensed establishments in the post mortem sector following a survey on tissue retrieval practices at their premises. The survey aimed to:

• Evaluate the level of tissue retrieval activity undertaken by establishments
• The identify what, if any, are the barriers to tissue retrieval; and
• To determine what, if anything, might be done to remove these barriers.

We have recently received enquiries from establishments who have expressed interest in viewing this report. In case you did not see it the first time round, you can find the report here.

HTA and HRA’s joint project on public understanding of how tissue and data can be used for health research

The HTA is undertaking a project in collaboration with the Health Research Authority. The overall objective of the project is to gain a greater understanding of public/patients views on the consent required for sharing donor data alongside tissue for research. 

As part of the project there have been public workshops considering:

• The public’s awareness of the importance of tissue being accompanied by patient data.
• What reassurances the public may need to provide their consent for data to be linked to donated tissue.
• When does tissue becomes data?
• When consent for tissue for research and clinical care is combined.
• Electronic dynamic consent, which would allow an ongoing dialogue between the researchers and the donor.

The work is being part funded by Sciencewise (part of the Department for Business, Energy and Industrial Strategy) and is supported by the Medical Research Council, Wellcome, and Genomics England.

A report on the results is scheduled to be published early next year. We expect the report will inform joint guidance on the topic, to be consulted on in 2018.

HRA/MHRA updated guidance on Good Clinical Practice (GCP) training 

The Health Research Authority’s (HRA) joint statement with the Medicines & Healthcare products Regulatory Agency (MHRA) advocates a proportionate approach to the application of Good Clinical Practice (GCP) to researcher training. It has been created in partnership with the Devolved Administrations and is supported by a number of organisations including the Academy of Medical Sciences and the Ethical Medicines Industry Group.

GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.

The statement has been supported by the HTA, as well as:

• Academy of Medical Sciences,
• Ethical Medicines Industry Group
• Faculty of Pharmaceutical Medicine
• HFEA
• Royal College of GPs
• Royal College of Radiologists; and
• UKCRC.

Imported body parts

Following a series of media articles on companies in the USA that supply body parts for training, it is a timely opportunity to reinforce our recommendations and expectations with regard to imported material. In support of lawful and ethical practices, we would advise people within our regulatory framework, who manage imported body parts, to refresh their knowledge of our published guidance, not least because we review supply arrangements, and may audit linked documentation, during our inspections.

It is well understood that all bodies and body parts should be treated with respect and dignity. There are also potential health and safety risks associated with fresh frozen cadaveric material. Our experience of regulating anatomy sector establishments in the UK is that there is a strong ethos of responsible and ethical custodianship. For example, it is a common experience for us to hear of establishments undertaking assurance visits of their suppliers.

In our Code of Practice on Anatomical examination, we give recommendations about consent assurances and provide further expectations with respect to ethical responsibilities. We also give consideration to potential health and safety risks, and how these can be managed.

We also provide a general policy on the sale of bodies, body parts and tissue on our website.

If you have any concerns or questions about any of the topics raised in or by this piece, please contact us.                                                                                                                                                          

Winter capacity update

We know that winter adds additional pressures on mortuary capacity, and this can pose problems if adequate numbers of refrigerated storage spaces are unavailable. 
 
In 2015, we published our Storage capacity and contingency arrangements in mortuaries: Guidance for Designated Individuals in HTA-licensed establishments. The guidance provides more detail on the challenges faced by mortuaries. It makes recommendations on how to strengthen contingency arrangements and mitigate risks resulting from a shortage of mortuary fridge and freezer spaces. 
 
In order to help you prepare for this winter, we have pulled all of these previous recommendations together in one place, along with some updated and new recommendations, on our website.