Human Tissue Authority

The regulator for human tissue and organs

No name

The full HTA guidance on the disposal of pregnancy remains is available to download as a PDF, it is recommended that you refer to both the guidance and these FAQs when drafting policies around the disposal of pregnancy remains.

When a woman has decided her pregnancy remains are to be returned to her to make her own arrangements but fails to arrange to collect them, the establishment should have a policy in place to manage this. 

In the first instance, it is advisable to establish contact with the woman within a reasonable timeframe to clarify her wishes; she may have changed her mind.

An establishment’s policy will need to consider options for the follow up of these cases that can be documented and referred to later, if required.

It may be necessary to send sensitive written correspondence, outlining what the woman is required to do and what will happen if she does not respond within a reasonable timeframe (which should not exceed 12 weeks).

Where a response is not received, it is for the establishment to decide the most appropriate method of disposal for the pregnancy remains.

Please see the HTA’s ‘Guidance on disposal of pregnancy remains following pregnancy loss or termination’, for further information.

The Human Tissue Act (HT Act) makes consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts and tissue from the living or the deceased, for the purposes specified in the HT Act. The consent provisions of the HT Act do not apply, however, if the material has been imported.

Nonetheless, the HTA considers it good practice to ensure mechanisms are in place in the source country for obtaining consent.

  • Imported cadaveric material should be obtained, used, handled, stored, transported and disposed of in accordance with the consent which has been obtained. Importers should satisfy themselves that the seeking of consent for the relevant purposes was part of the process by which the material was obtained.
     
  • Imported cadaveric material should be accompanied by a donor sheet, confirming the low-risk status of the donor and including testing results.
     
  • Imported specimens should have been confirmed negative for HIV disease, Hepatitis B, Hepatitis C, Tuberculosis, a transmissible spongiform encephalopathy (such as Creutzfeldt-Jakobs Disease) and Meningitis by the supplier in the source country, and if positive should have been excluded from donation. Donor testing should have been carried out by a licensed or accredited laboratory and the donor information should have been reviewed and signed off before any specimen was considered available for release.
     
  • The DI should assure themselves that all imported specimens were procured, wrapped and shipped in fashion to prevent accidental exposure and should conform to the international standards for the transport of hazardous clinical material. If any specific requests were made by the deceased regarding disposal when consent was obtained, such requests must be carried out. This may include, for example, the return of material to the country of origin.

Establishments should ensure the following:

  • Make sure that your establishment is using appropriate procedures and conditions for freezing, thawing and storing frozen bodies and body parts. The processes for preparing and storing bodies and body parts should have been reviewed and ratified by your establishment.
     
  • All staff working on the process should be trained, and familiar, with all aspects of the procedure. Refresher training and competency assessments should be carried out regularly.
     
  • Given the practical and personal challenges of working with this type of material, establishments should ensure that staff have access to advice, guidance and support, both through the organisational structure and independent organisations.
     
  • Ensure that donors who have tested positive for HIV disease, Hepatitis B, Hepatitis C, Tuberculosis, a transmissible spongiform encephalopathy (such as Creutzfeldt-Jakob Disease) and Meningitis have been excluded from donation by the supplier in the source country. Donor testing should have been carried out by a licensed or accredited laboratory and all donor information should have been reviewed and signed off before any specimen is considered available for release.
  • Ensure that any material being loaned is covered by an agreement specifying, at a minimum:
    • who is responsible for custodianship of the material at every stage
    • how and where the material will be used at the receiving establishment,
    • storage conditions and the fate of the material after it has been used at the receiving establishment (e.g. sensitive disposal or return to the loaning establishment).
  • It is recommended that appropriate staff from the loaning establishment consider visiting the receiving establishment and undertaking a suitability assessment

For additional information, please see ‘Managing Infection Risks when Handling the Deceased’ issued by the HSE in July 2018 which provides further detail on infection risks associated with working with the deceased, and replaces the previous HSE guidance, Safe working and the prevention of infection in the mortuary and post-mortem room (2003) and Controlling the risks of infection at work from human remains (2005).

The person wishing to donate their body should be given all the information necessary to make an informed decision. Consent forms should cover consent for all possible uses of the body. Relatives should also be informed of the possible timeframe in which the body may be used before completion of the donation. They should also be made aware that the decision on what purpose the body will be used for is made at the time of death and the factors that may influence the use.  

There is further guidance on improving transparency in the information used to support the seeking of consent for body donation can be found in the HTA Code of Practice C Anatomical Examination and the HTA website here.  

If there is the potential for specimens to be used for commercial purposes or exported, the potential donor should be made fully aware of these possibilities and should provide their informed consent.

If there is a potential for specimens to be used for training and education, the establishment should check the qualifications and suitability of the course leaders before permitting a course to take place. They should also check to see if the course reflects the consent that the donor has given.

Risks assessments should include the risks relating to premises, individuals coming into contact with fresh frozen material, practices and procedures connected with licensed activities including:

  • Disease transmission to staff or delegates, including those who may be at increased risk (e.g. due to a compromised immune system)
  • Dignity of the donors and the cadaveric material
  • Storage of cadaveric material and contingency arrangements
  • Security of the premises
  • Preparing the cadaveric material for courses
  • Transportation risks
  • Loaning of cadaveric material
  • Likelihood of visitors and untrained staff  (e.g. students, visitors, maintenance) coming into contact with infected specimens without appropriate supervision

Documented risk assessments should include an evaluation of the level of risk and, where appropriate, the mitigating actions identified and the level of residual risk remaining.

Establishments should make an assessment of the likelihood of disease transmission from fresh frozen bodies or body parts, and take appropriate steps to minimise the risks of disease transmission to individuals handling the material.

We recommend liaison with local Infection Control or Occupational Health services to ensure compliance with organisational policies and national guidelines.

The following are also possible ways to reduce risk:

  • Screening living donors (e.g. tests or lifestyle questionnaires)
  • Checking test results on material or associated donors, confirming low-risk infection status
  • Confirming the serostatus of donations prior to acceptance
  • Ensuring that testing was carried out by an accredited/licensed laboratory
  • Ensuring appropriate ventilation in storage and training areas
  • Checking the immunisation status of delegates before contact with bodies or body parts
  • Training for individuals in SOPs relating to bodies/body parts
  • Ensuring appropriate PPE is available
  • Appropriate conditions for the transport of material
  • Appropriate storage conditions, cleaning and decontamination
  • Management and supervision of course delegates using material

The guidance clarifies the practices that should already be in place to undertake removal of regenerative material within the law, and put the donor’s best interests at the forefront of any decision.  

Key issues to be aware of:

  • The person giving consent (in cases where the donor is a child) must have parental responsibility for the child donor and the HTA will need to be assured that this is the case.
     
  • A capacity/competence assessment must be carried out on all child donors, except where it is clear the donor lacks competence, for example, if the donor is a very young/pre-verbal child.
     
  • The referral letter must confirm that the clinician with responsibility for the donor has had a conversation with the person consenting on behalf of the donor, about how they have considered the best interests of the donor in their decision. The letter must also confirm that the clinician is satisfied that the donation is in the best interests of the donor.

It is important to continue to explain the role of HTA to families and provide the HTA leaflet ‘Our role in bone marrow and peripheral blood stem cell donation’ available on the HTA website

The HTA only has the power to make a decision on a case if the donor is a child not competent to consent, or an adult lacking capacity to consent. The HTA must therefore explore competence before confirming whether or not we can make a decision on the case. If a child appears to have competence based on the AA interview, the HTA may:

  • request that the clinician referring the case provides the HTA with details of the competence assessment that was undertaken; and
     
  • if the matter remains unclear, make an application under the Children Act 1989 for the Court to decide if the donor child is competent to make their own decisions about medical treatment. The Court would then decide whether the child has competence to consent to the procedure for themselves.

Yes. The law is clear that a child becomes legally competent to make their own decisions on medical treatment matters when the child has sufficient capabilities and intelligence to fully understand what is proposed. If a child has this level of understanding and intelligence the child can give or refuse consent on his/her own behalf. 

There is no threshold age when children become competent; this should be assessed on a case by case basis. 

The HTA regulates organ donation and transplantation under the European Union Organ Donation Directive, which was transposed into UK law via The Quality and Safety of Organs Intended for Transplantation Regulations 2012 and the Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014.

The HTA audits licensed establishments across the UK by undertaking on-site visits to ensure that each Hospital that is licensed meets the requirements set out in the Regulations.

You can read the audit reports for each licensed hospital, which are published here.

Further information on our role can be found here.  

Yes, it is possible in some circumstances to donate organs and/or tissues from infants. Advice should be sought from medical professionals if such a situation occurs.

Further information on the diagnosis of brain stem death in infants and children can be found here

Deceased donation in the UK is unconditional and subject to clinical priority. However, in some exceptional cases people can request that an organ/s be given to a family member or close friend who is waiting for an organ transplant on the national waiting list. The requested allocation of a deceased donor organ can be considered if this is carried out in line with NHSBT policy.

Yes. There are rare occasions where an exchange of organs between European countries takes place. This means that patients in the UK benefit from an organ transplant they otherwise may not have received.  NHS Blood and Transplant facilitate and organise this on the occasions when it occurs.

The EU Organ Donation Directives aim to align standards in the field of organ donation across the European Union, making sure that where organs are exchanged, the standards of quality and safety are maintained.  

On some occasions when a person dies, their organs and/or tissues might be suitable for use in transplantation.

Suitable organ donors are those that fall into one of the following categories:

Brain stem death - This is where a person no longer has activity in their brain stem due to a severe brain injury. They have permanently lost the potential for consciousness and the capacity to breathe. This may happen even when a ventilator is keeping the person's heart beating and oxygen is circulated through their blood.

Circulatory death – this is the irreversible loss of function of the heart and lungs after a cardiac arrest from which the patient cannot be resuscitated. It can also be the planned withdrawal of life-sustaining treatment from a patient within the Intensive Care Unit or the Emergency Department.

Having a previous medical condition or being older does not always prevent you from becoming an organ or tissue donor.

For more information, please visit NHS Blood and Transplant’s website.

Donated organs can only be used for the purposes for which consent is in place. The Organ Donor Register can only be used to register wishes in relation to organ and tissue donation for transplantation.

Consent can also separately be given for research and other purposes (called “scheduled purposes”) set out in the Human Tissue Act 2004 (see Schedule 1 (1) of HT Act).

Where consent has been given by the donor in life, but relatives object to organ or tissue donation proceeding, then relatives should be sensitively supported to respect the donor’s consent, to ensure his or her wishes are fulfilled. A relative’s objection does not nullify appropriate, valid consent from the prospective donor.

In practice however, if a family feel strongly that they cannot support the donation proceeding, despite staff answering their questions and concerns, donation does not go ahead.

It is very important to discuss your donation wishes with your family; this makes the decision easier for families when they are approached at a very difficult time.

NHS Blood and Transplant has also published information on consent.

Please see FAQs for further information

In England and Northern Ireland

In England and Northern Ireland, the removal, storage and use of organs or part organs from a deceased person for transplantation is governed by the Human Tissue Act 2004. Before organs can be removed, stored or used for transplantation, appropriate consent must be obtained. The HTA’s role is to provide guidance on what constitutes lawful consent to organ and tissue donation, after death has been diagnosed.  

The NHS Organ Donor Register operates throughout the UK and allows you to record your decision. It allows you to state whether you wish to donate all of your organs and tissues or some of your organs and tissues. It also allows you to register an opt out decision. Your family will not be approached about organ donation if you have registered an opt out decision.

The register also allows you to nominate a representative to make a decision about organ donation on your behalf. If there is no record of your wishes, consent can be obtained from a person nominated by you to act on your behalf. If no one has been nominated, a person in a ‘qualifying relationship’ immediately before your death can make a decision. If you register on the NHS Organ Donor Register to be a donor, and donation is a possibility when you die, then a dedicated nurse specialising in organ donation will support your family, let them know of your decision, and help to honour it.

Further information about our role can be found here.

The public guide to the code of practice is available here.

NHS Blood and Transplant also publish information about organ donation and this is available here.

In Scotland:

The HTA’s remit does not extend to Scotland in terms of consent for organ donation.  However, we do licence and undertake on-site visits of each Transplant Centre in Scotland to ensure the requirements set out in the Regulations under the European Union Organ Donation Directive are met.

A separate piece of legislation, the Human Tissue (Scotland) Act 2006, applies to Scotland and professionals working in the field of organ and tissue donation will work under that legislation. Any adult or child aged 12 and over, who is able to make their own decisions can give permission for their organs or tissue to be donated. Children under the age of 12 cannot give permission themselves. If a child under the age of 12 dies, only their parent or guardian can give permission for their organs or tissue to be donated.

The NHS Organ Donor Register operates throughout the UK and allows you to record your decision about organ donation. It allows you to state whether you wish to donate all of your organs and tissues or some of your organs and tissues. It also allows you to register to opt out of organ and tissue donation. Your family will not be approached about organ donation if you have registered an opt out decision.

It allows you to appoint a representative to make this decision on your behalf. If you register on the NHS Organ Donor Register to be a donor, and donation is a possibility when you die, then a dedicated nurse specialising in organ donation will support your family, let them know of your decision, and help to honour it.

Further information about organ donation in Scotland is available here.

A useful information leaflet published by the Scottish Government is available here.

In Wales:

Since December 2015, a deemed consent system has been operational in Wales. The Human Transplantation (Wales) Act 2013 allows for consent to deceased organ donation to be deemed to have been given when a person both lived and died in Wales; there are however a number of exceptions to this.

The NHS Organ Donor Register operates throughout the UK and allows you to record your donation decision. It allows you to state whether you wish to donate all of your organs and tissues or some of your organs and tissues. It also allows you to register to opt out of organ donation. Your family will not be approached if you have registered an opt out decision.

Where no decision is recorded on the Organ Donor Register (either opt-in or opt-out), individuals will be treated as having no objection to donating their organs. This is called "deemed consent".

Further information about our role can be found here

The HTA’s Code of Practice on the Human Transplantation (Wales) Act 2013 is available here.

The Welsh Government also publish useful information about the system in Wales available here

The Miscarriage Association have developed a suite of learning resources for professionals, informed by women and their partners who have experienced miscarriage, ectopic pregnancy or molar pregnancy, and by health professionals who care for patients with pregnancy loss.

You can find these materials on their website here - http://www.miscarriageassociation.org.uk/for-health-professionals/learning/.

Directive 2004/23/EC and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (the Quality and Safety Regulations) make provision for an exemption to the requirement for a licence, when procurement of tissue and cells takes place during the same surgical procedure in certain circumstances.

Please contact us if you think that you may be affected by this exemption or if you have any further questions.

Pregnancy remains may be packaged individually in separate containers or collectively for disposal. If the practice adopted by providers is to package them collectively, they should ensure that the information they give to women about disposal options makes it clear that, unless they object, their pregnancy remains will be collected together with others in one receptacle for disposal separate from clinical waste. Some women may prefer that their pregnancy remains are packaged separately; if they make this known, their request should be respected and acted upon.

The current practice of collecting several pregnancy remains in one receptacle separate from clinical waste can be the default position, providing there are safeguards in place that ensure women know they have choices, that they are given the opportunity to make their choice and that their wishes are carried out.

Schedule 1 of the Human Tissue Act 2004 (the Act) sets out ‘performance assessment’ as a ‘scheduled purpose’.

An HTA licence is required if the human cellular material (‘relevant material’) to be stored for performance assessment has been removed from the deceased.

The Act also sets the requirement that consent must be obtained to store and use relevant material from deceased persons for the purpose of performance assessment.

These consent and licensing requirements do not apply if the relevant material has been removed from the living. However, this does not mean that consent to store and use relevant material for this purpose should not be sought where it appropriate and reasonable to do so.

In Vitro Diagnostic Medical Devices
Some companies store and use relevant material to evaluate ‘in vitro diagnostic medical devices’ (IVDs), such as pregnancy test kits, which are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).

The regulation of IVDs mandates certain types of testing to ensure that they are safe and effective. Where relevant material is stored and used to carry out the mandatory testing of IVDs, this activity is regarded by the HTA as ‘performance assessment’ as set out in the Act.

The activity is therefore exempt from the consent and licensing requirements under the Act, provided that the material has been removed from the living. If the relevant material is obtained from the deceased, then advice from the HTA should be sought.

If an establishment intends to store relevant material for research informing the development of new IVDs, advice from the HTA about consent and licensing requirements should also be sought.

Information on the regulation of human tissue research, including exemptions from HTA licensing, can be found in the HTA’s Code of Practice on Research.

If information on the regulation of IVDs is required, please contact the MHRA.

Wolfson Neuroscience Laboratories
Imperial College Faculty of Medicine
Hammersmith Hospital Campus
Burlington Danes Building
160 Du Cane Road
London W12 0NN

Contact: Dr George Gveric
T 020 7594 9732
F 020 7594 9733
E pdbank@imperial.ac.uk

Wolfson Neuroscience Laboratories
Imperial College Faculty of Medicine
Hammersmith Hospital Campus
Burlington Danes Building
160 Du Cane Road
London W12 0NN

Contact: Dr George Gveric
T 020 7594 9734
F 020 7594 9735
E ukmstissuebank@imperial.ac.uk

Neuropathology Dept
Level 1, West Wing
John Radcliffe Hospital
Headley Way, Headington
Oxford OX3 9DU

Contact: Dr Olaf Ansorge
T 01865 234904 / 01865 234403 (Includes out-of-hours message service)
F 01865 231157
E olaf.ansorge@ndcn.ox.ac.uk

University of Bristol
Level 1, Learning & Research
Southmead Hospital
Bristol, BS10 5NB

Contact: Laura Palmer
T 0117 414 7821
E laura.e.palmer@bristol.ac.uk

UCL Institute of Neurology
Institute of Neurology
1 Wakefield Street
London WC1N 3BG

Contact: Lynn Haddon
T 020 7837 8370
F 020 7278 4993
E l.haddon@ucl.ac.uk

Regional Neuropatholgy Service
The Royal Victoria Hospital
Grosvenor Road
Belfast BT12 6BA

Contact: Dr Brian Herron
T 028 9063 2319
E brian.herron@belfasttrust.hscni.net

Newcastle Brain Tissue Resource
Institute for Ageing and Health
Newcastle University
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL

Contact: Debbie Lett
T: 0191 208 1231
E nbtr@ncl.ac.uk

Cerebral Function Unit
Greater Manchester Neuroscience Centre
Hope Hospital
Stott Lane
Salford
M6 8HD

Contact: Stephen Chew-Graham
T 0161 789 7373 (ext 2561)
E brainbank@manchester.ac.uk

Institute of Psychiatry
Box PO65
King's College London
De Crespigny Park
London SE5 8AF

Contact: Dr Claire Troakes
T 020 7848 0290 (Office hours)
F 020 7848 0275
E brain.bank@kcl.ac.uk
W https://www.kcl.ac.uk/ioppn/depts/bcn/Our-research/Neurodegeneration/brain-bank.aspx

Institute of Psychological Medicine & Clinical Neuroscience
Hadyn Ellis Building
Maindy Road
Cathays
Cardiff
CF24 4HQ

Contact: Dr Rebecca Sims
T 0292 068 8042
E ADResearch@cardiff.ac.uk

The Department of Neuropathology coordinates brain donation in Wales. If you would like to make a brain donation for medical research please use the contact details above.

Cambridge Brain Bank
Department Histopathology
Level 5 Box 235
Addenbrooke's Hospital
Hills Road
Cambridge CB2 0QQ

Contact: Beverley Haynes / Jenny Wilson
T 01223 217336
E brbank@addenbrookes.nhs.uk

Brains for Dementia Research Coordinating Centre Office
Ground Floor, Edwardson Building
Newcastle University
Institute of Neuroscience
Campus for Ageing and Vitality
Newcastle-upon-Tyne
NE4 5PL

Contact: Nicky Barnett - BDR Senior Manager
T 0191 208 2109
BDR.Coordinatingcentre@ncl.ac.uk
www.brainsfordementiaresearch.org.uk

An organ is a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with a significant level of autonomy. A part of an organ is also considered to be an organ if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation for example, a liver lobe.  

Composite tissue is a construct that contains multiple structures that may include skin, bone, muscles, blood vessels, nerves and connective tissue, that is recovered from a donor as an anatomical or structural unit, without altering its relevant characteristics. Composite tissue requires its own blood supply and can be transplanted to an appropriate recipient. Composite tissue falls within the HTA’s ODT framework and examples of composite tissue for transplantation include, face, hand and leg.

The European Union Organ Donation Directive (2010/53/EU) (EUODD) required Member States to identify a Competent Authority to oversee the requirements of the Directive.

In 2011, the UK Government, and the devolved Governments appointed the Human Tissue Authority (HTA) as the Competent Authority for the EUODD in the UK.

The requirements set out by the Directives have been enshrined into UK law through The Quality and Safety of Organs Intended for Transplantation Regulations 2012 and The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014.The HTA has implemented a regulatory framework ‘The Quality and Safety of Organs Intended for Transplantation – a documentary framework’ (PDF) to provide guidance to professionals on how the quality and safety standards of the EUODD should be met.

The HTA has put in place a service level agreement with National Health Service Blood and Transplant (NHSBT) to assist with the following Competent Authority functions: Supervision of the exchange of organs; to keep records and make reports relevant to procurement and transplantation centres; and to keep a register and to follow up living donors.

The agreement with NHSBT also includes the requirement for the management, reporting and investigation of serious adverse events or adverse reactions (SAEARs). Any SAEAR that may influence the quality and safety of organs must be reported to NHSBT within 24 hours of discovery. NHSBT acts on behalf of the HTA to carry out an investigation into the incident and submit their findings to the HTA for consideration.

The regulations require that activities involving procurement and transplantation are licensed. The activity of procurement includes one or more of the following: donor characterisation, organ characterisation, preservation of an organ, making arrangements to transport an organ and retrieval of an organ. The activity of transplantation includes organ characterisation, preservation of an organ, making arrangements to transport an organ and implantation of an organ. Further information on the definitions of these activities can be found in ‘The Quality and Safety of Organs Intended for Transplantation – a documentary framework’ (PDF)

If you carry out, or intend to carry out, one or more of the above activities you require a licence from the HTA to do so. Multiple activities, covering both procurement and transplantation, can be carried out under a single licence. A licence application can be made electronically by using the form via the HTA web Portal. You will need to register as a user before you can access the application form. The licence application must state which activity or activities are planned.

 

The HTA prefers that the licence holder is the corporate body where possible (e.g. an NHS Trust). Establishments applying as a corporate body should provide the contact name of an individual who will act as a representative for the corporate body (Corporate Licence Holder Contact [CLHC]). It is a statutory requirement that the licence holder ensures compliance with the:

  • Conditions of the licence;
  • HTA directions imposed on the licence

Licences granted under the Human Tissue (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 (The Regulations) apply to corporate bodies and persons rather than to premises. This means that licensed individuals, or staff employed by licensed corporate bodies, such as NHS Trusts or NHSBT, can undertake licensed activities in a range of locations that are authorised by their employer.

Example:

A National Organ Retrieval Service (NORS) team is authorised to carry out licensable activities, such as procurement, under the licence of the establishment where they are based, regardless of the premises on which they carry out the licensable activities. For example a Newcastle NORS team that carry out licensable activities e.g. procurement in Staffordshire will be doing so under the Newcastle ODT licence. 

Although NHSBT keeps a register of all living donors for follow-up, all transplant centres are required to keep this information on site. Local practice will vary depending on how follow-up clinical visits, or visits to local GPs or hospitals are managed. Paragraph 23 of the EU Directive (2010/45/EU) on standards of quality and safety of human organs intended for transplantation ‘states that the highest possible protection of living donors should be ensured.’

Donors should be followed up to identify any reactions or disease processes which may have potential consequences for both organ recipients and living donors. For overseas donors, both the donor and the managing general practitioner should be informed by information provided in discharge letters of reporting any serious adverse events or reactions to the transplant centre.
 

Example:

  • if a living kidney donor develops a tumour, the transplant centre should be informed to ensure that the organ recipient is appropriately monitored

You are required to notify the HTA with details about any changes to licensable activities, organ types, establishment address or location details.

Examples of changes you must notify the HTA about include:

  1. We would like to add another organ or composite tissue to our list
  2. We would like to remove an organ from our list
  3. The licence holder (Trust) has changed
  4. The licence holder (contact) has changed
  5. The licence holder address has changed

Changes to your licence must be submitted via licensing.enquiries@hta.gov.uk  

The above list is not exhaustive; please contact the HTA if you are unsure of whether a change at your establishment needs to be submitted as a licence change. Changes to licenses will be considered on a case by case basis.

Information about fees for this sector can be found on the fees and payments page.

An on-site audit aims to review operational policies, procedures and practices in place. The audit involves a visual inspection of the premises, a review of documentation and discussions with a range of staff involved in licensable activities. This enables the HTA to identify any shortfalls against the assessment criteria and the conditions of the licence. We also offer advice and guidance on areas requiring further improvement as well as identifying areas of good practice. 

The EUODD does not specify how frequently audits should occur. The EUODD requires that ‘procurement organisations and transplantations centres are controlled or audited on a regular basis’. A number of considerations are factored in to deciding which establishments are prioritised for audit; these include, for example, the results of compliance updates. The HTA develops its ODT compliance updates to take into consideration information gathered following submission of serious adverse events and reactions and shortfalls identified during audits.

All establishments will be given three months notice of a routine planned onsite audit.

A comprehensive suite of National Operating Procedures (NOPs) are available on the NHSBT microsite. There are NOPs covering:

  • Donor and Organ Characterisation Assessment and Allocation in Deceased and Living Donation and Transplantation
  • Verification of Donor Identity Consent and Authorisation Organ and Donor Characterisation in deceased and Living Donation and Transplantation
  • Packaging Labelling and Transport of Organs in Deceased and Living Donation and Transplantation
  • Management of Procurement Material and Equipment in Deceased and Living Donor and Transplantation
  • Activities to be Performed Under the Guidance of a Registered Medical Practitioner
  • Transfer and Storage of Donor and Organ Characterisation Information and Storage of Traceability Data

The NOPs contain mandatory information which must be documented in local operating procedures, in order to meet HTA assessment criteria. Where establishments do not already have equivalent procedural documentation in place, they are encouraged to adapt the NOPs in line with the establishment’s local procedures to ensure that they reflect how activities are carried out locally. 

The NOPs must be adopted with local amendments as appropriate or alternative procedures must be developed which meet the regulatory requirements. The documentary framework document provides information about these requirements. 

 

Yes. There must be consent for research in place from the donor or a person in a qualifying relationship to the donor immediately before their death.

If organs are removed for the purpose of transplantation by a NORS teams and found unsuitable for transplantation, they can be removed for a scheduled purpose such as research under the Human Tissue Act. A separate removal licence is not required.

If the organs are removed for research only, the establishment must have a HTA licence for removal for research under the Human Tissue Act. Most Post Mortem establishments already hold this licence which can be extended by the HTA, to cover other areas where removal of tissue from the deceased takes place. Designated Individuals are advised to contact the HTA if they wish to extend a licence to cover theatres to enable this activity to take place.

For more information please refer to paragraphs 56-57 of the documentary framework document and the HTA website.  

A serious adverse event (SAE) is defined in the Regulations as ‘any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity’.

SAEs that may influence the quality and safety of an organ and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs must be reported and investigated. The HTA also requires that any SAEs which occur at a transplant centre which may influence the quality and safety of an organ must be reported and investigated.

A serious adverse reaction (SAR) is defined in the Regulations as ‘an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity’. SARs observed during or after transplantation which may be connected to the testing, characterisation, procurement, preservation and transport of organs must be reported and investigated. 

It is a statutory condition of an ODT licence to report SAEARs to NHSBT on behalf of the HTA within 24 hours of discovery of the incident by the licence holder. Establishments should have in place operating procedures for the management of a serious adverse event or a serious adverse reaction. 

The HTA directs, that for living donation, only CPA or UKAS accredited laboratories should be used, unless by doing so there is a risk to the donor or recipient which would outweigh the risk of using a non-accredited laboratory or one with an unknown status, e.g. due to time constraints in an emergency liver donation.

For deceased donation, establishments should endeavour to use only laboratories accredited by CPA or UKAS. The HTA would expect licence holders to establish the accreditation status of laboratories that are frequently used for donor or organ characterisation, and to review and update this information on a regular basis. Where CPA or UKAS accredited laboratories are not available, a risk assessment of the testing laboratory should be performed and the implanting surgeon should be informed. The results of the risk assessment should be recorded in donor files.

In the context of testing, examples of SAEs may be related to mislabelling, transcription errors, loss of traceability of samples, failure in testing protocols etc. All incidents should be reported to NHSBT. NHSBT will then report incidents falling into the category of SAEARs to the HTA.

Testing laboratories are not licensed by the HTA and should report SAEs to the licence holder, who will then submit a report to NHSBT. Further guidance is provided in the SAEARs Guidance Document (PDF).

The Human Tissue Act 2004 (the HT Act) and Transplant Regulations place an obligation on the Human Tissue Authority (HTA) to assess all applications for living organ donation.

To grant approval under the Transplant Regulations in England, Wales and Northern Ireland, the Authority must be satisfied:

  • That no reward has been given or is to be given; and that
  • When transplantable material is removed, consent for its removal for the purpose of transplantation has been given, or its removal for that purpose is otherwise lawful.

In Scotland, to grant approval under the Regulations (Scotland), the Authority must be satisfied that:

  • No reward has been or is to be given in contravention of section 20 of the Human Tissue (Scotland) Act 2006, which prohibits commercial dealings in parts of the human body for transplantation;
  • There is no evidence of duress or coercion affecting the donor’s decision (and in the case of directed donation, the recipient’s decision to accept the organ); and
  • The relevant requirements of the Regulations (Scotland) under the Human Tissue (Scotland) Act 2006 have been met.

For either legislative or policy purposes, the HTA distinguishes a number of different concepts in living organ donation which includes whether the donor and recipient have a genetic or pre-existing emotional relationship e.g. friends of long standing, before the need for a transplant arose.

The different types of donation are:

  • Directed
  • Paired/pooled
  • Non-directed altruistic.
  • Directed altruistic

NHS Blood and Transplant (NHSBT) are responsible for the allocation of organs from deceased donors, and from donors who have offered their organs altruistically and do not know who the recipient will be.

More information on the roles of the HTA and NHSBT is available here.

The Human Tissue Authority (HTA) has been responsible for regulating living organ donation since 1 September 2006. This is when the Human Tissue Act 2004 came into force.

The Human Tissue Authority also became the UK Competent Authority for the European Union Organ Donation Directive (EUODD) in August 2012. This gave the HTA responsibility for ensuring high standards (quality and safety) are met for living and deceased organ donation and transplantation. The standards cover both procurement (characterisation of donor; characterisation, retrieval, preservation and transport of an organ) and transplantation (organ characterisation, preservation, transport and implantation).

Further information is available here.

Copies of relevant human tissue legislation are available via the government legislation website.

  • Human Tissue Act 2004 (the HT Act)
  • Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (Transplant Regulations)
  • Human Tissue (Scotland) Act 2006
  • Human Organ and Tissue Live Transplants (Scotland) Regulations 2006
  • Quality and Safety of Organs Intended for Transplantation Regulations 2012
  • Human Transplantation Act (Wales) Act 2013

A ‘research tissue bank’ (‘biobank’) is defined under the Governance Arrangements for Research Ethics Committees (GAfREC) as: 

‘A collection of human tissue or other biological material, which is stored for potential research use beyond the life of a specific project with ethical approval or for which ethical approval is pending’. 

The HTA has a statutory responsibility to make decisions on all cases of bone marrow and PBSC donation where the donor is a child who lacks competence to consent or the donor is an adult lacking capacity to consent.

Several cases over recent years have led the HTA to seek very specific legal advice. Following receipt of this advice, and under guidance from the HTA Authority (Board) members, we have taken the opportunity to strengthen the current regulatory system whilst reducing regulatory risk and ensuring that the approach we take in relation to our statutory responsibilities in this area is clear and proportionate.

There are three main areas of change to be aware of:

  • More specific focus on the best interests of the donor – the HTA must be assured in each case that the best interests have properly been considered by the person providing consent.
  • A formal referral letter must be written in each case which must include confirmation that the donor’s capacity has been explored, and confirmation that the donor lacks the competence to make the decision for himself/herself.
  • HTA must be assured that the person consenting on the donor’s behalf has parental responsibility. 

A research tissue bank can store different types of biological material, including DNA, serum, cell lines and/or ‘relevant material’. ‘Relevant material’ is defined by the Human Tissue Act 2004 (HT Act).

The HTA has published a new guidance document entitled ‘Guidance for Bone Marrow and Peripheral Blood Stem Cell Transplant Teams and Accredited Assessors in England, Wales and Northern Ireland’.

This guidance contains up to date information on the requirements of the law, what is expected of clinical teams and Accredited Assessors, as well as useful case studies. It provides clearer information on the role and responsibilities of the HTA, for example, what the HTA must be ‘satisfied of’ in order to give approval for each donation. 

The guidance also includes a list of useful links and resources.

The role of the HTA is to ensure that human tissue is used safely and ethically, and with proper consent. The HTA regulates, through licensing, the removal, storage and use of human tissue for scheduled purposes. Although the disposal of pregnancy remains, which are considered to be the mother’s tissue, is not within the scope of our regulatory remit, the HTA was asked by Professor Dame Sally Davies, Chief Medical Officer, with responsibility for developing guidance in this area and working with other organisations to monitor compliance. 

The guidance applies in England, Wales and Northern Ireland to pregnancy loss or terminations of pregnancy that have not exceeded the 24th week of pregnancy, irrespective of cause or origin, where no signs of life have been detected following the loss, and whether or not fetal tissue can be identified.

The brain bank organising the donation will contact you to ask you to perform the retrieval, they will inform you of the way they wish the brain to be removed and stored until collection and they will provide you with a copy of the consent form.

The HT Act refers to ‘relevant material’, defined as ‘material, other than gametes, which consists of or includes human cells’.

Relevant material taken from a deceased person for analysis includes tissue samples, bone, blood, urine, stomach contents, hair and nails. DNA is not relevant material, as it does not contain cells.

A list of relevant material under the HT Act is available here.

Procurement is defined by the EU Tissue and Cells Directives as a process by which tissues or cells are made available. This includes the donor selection procedure as well as the physical act of removing tissue and / or cells intended for patient treatment (human application).

We regulate, through an independent assessment process, the donation of organs from living people across the UK. We work to ensure that valid consent has been given by the donor so they fully understand any risks, donate of their own free will and that no reward is associated with the transplantation.

Deceased organ donation

For organ donation from deceased people, we also oversee the legal consent requirements by providing advice and guidance to professionals.

Licensing quality and safety of organs intended for transplantation

We also issue licences, across the UK, under EU laws, which ensures the quality and safety of transplanted organs.

‘Relevant material’ is material other than gametes, which consists of, or includes, human cells. Relevant material does not include: (a) embryos outside the human body, or (b) hair and nail from the body of a living person. There is a list of relevant material on the Human Tissue Authority’s (HTA’s) website. 

Yes. The law is clear that a child becomes legally competent to make their own decisions on medical treatment matters when the child has sufficient capabilities and intelligence to fully understand what is proposed. If a child has this level of understanding and intelligence the child can give or refuse consent on his/her own behalf. 

There is no threshold age when children become competent; this should be assessed on a case by case basis. 

Women define their pregnancy according to their own circumstances, values, understanding and beliefs. The HTA and professionals in the field consider that any attempt to categorise the pregnancy may result in health professionals viewing the pregnancy differently from the woman involved. Furthermore, if the mode of disposal were to be linked to types of pregnancy or pregnancy loss, some women may find themselves being denied certain choices. Acting in response to the needs and wishes of the women first and foremost helps avoid such problems.

It is the responsibility of the brain bank to ensure that consent has been given, and they will provide you with a copy of the consent form when making arrangements for the retrieval. If you do not receive a copy of the consent form, or if you are uncertain about it for any reason, you should contact the brain bank co-ordinator as soon as possible. On no account should you proceed with the retrieval without confirmation from the brain bank that appropriate consent has been obtained under the Human Tissue Act 2004.

Under the HT Act, the HTA licenses premises on which the following activities take place:

  • anatomical examination
  • post mortem examination
  • removal of relevant material from the deceased for use for scheduled purposes
  • storage of anatomical specimens
  • storage of bodies or relevant material from human bodies for use for a scheduled purpose
  • public display of a body or relevant material from the body of a deceased person

The HTA does not licence individuals.

The HTA carries out inspections of licensed establishments to ensure that licence conditions and standards are being met.

The HTA codes of practice explain the HT Act’s consent and licensing requirements for establishments in the sectors it licenses.

In relation to the post mortem sector, the HTA licenses premises where post mortem examinations take place, where removal of tissue from the deceased takes place and where bodies are stored prior to post mortem examination and tissue samples are stored for analysis. It has no regulatory remit over the activities of coroners, and post mortem examinations and tissue retained ‘for purposes of functions of coroners’ or under the authority of coroners are exempt from the consent requirements of the HT Act.

If you or someone within your organisation is carrying out procurement of tissues and / or cells for patient treatment, an HTA licence will normally be required. Procurement may be carried out by an unlicensed establishment under the terms of a third party agreement, provided:

 

An existing holding is material from the living or deceased that was already held for use for scheduled purposes when the HT Act came into force on 1 September 2006.

The HTA only has power to make a decision on a case if the donor is a child not competent to consent, or an adult lacking capacity to consent. The HTA must therefore explore competence before confirming whether or not we can make a decision on the case. If a child appears to have competence based on the AA interview, the HTA may:

  • request that the clinician referring the case provides the HTA with details of the competence assessment that was undertaken; and
  • if the matter remains unclear, make an application under the Children Act 1989 for the Court to decide if the donor child is competent to make their own decisions about medical treatment. The Court would then decide whether the child has competence to consent to the procedure for themselves.

Both cremation and incineration are processes used to destroy human body parts. Cremation is used as an alternative to burial and is often associated with a ceremony and/ or religious or spiritual ritual. Cremation takes place within a registered crematorium under the oversight of a Registrar, and the relatives of the deceased may be present.

Technically, cremation and incineration are similar processes, both using burning to reduce part or whole deceased human bodies to basic chemical compounds in the form of ashes. Incineration of human tissue as clinical waste is normal practice and is subject to specific regulation. Incineration does not usually have any associated ceremony.

Cremation is regulated in England and Wales by a permit issued by Local Authority Regulators and in Scotland by SEPA, as required by the Secretary of State’s Guidance for Crematoria PG5/2(12). These notes are aimed at providing a strong framework for consistent and transparent regulation of installations regulated under the statutory Local Air Pollution Prevention and Control (LAPPC) regime in England and Wales, Scotland and Northern Ireland. Incineration must take place in accordance with a permit granted under regulation 10 of the Pollution Prevention and Control (England and Wales) Regulations 2000.

Incineration of fetal tissue is not banned in Scotland, but is considered unacceptable in any circumstance. Incineration against the wishes of the woman is considered unacceptable in England, Wales and Northern Ireland. The HTA has developed its guidance to operate within the current legislative framework. In doing so, it has put the needs and wishes of the woman at the heart of the guidance, recognising that in some circumstances, incineration may be her preferred option.

The HTA has a statutory duty to carry out its functions having regard to the principles of best regulatory practice, including the need to be proportionate. At the time of writing the guidance, pregnancy remains under 24 weeks gestation are not subject to burial and cremation legislation and Burial and Cremation Authorities are under no obligation to provide a service to dispose of these remains. The HTA is mindful of the practical challenges associated with the disposal of pregnancy remains and does not consider it would be proportionate to remove the option of incineration in relation to the disposal of pregnancy remains where this is the woman’s choice or where, when leaving the decision to the hospital, the hospital considers this the most appropriate method of disposal.

The vast majority of mortuaries have a licence for removal of tissues for research, as well as for post-mortem examination. If in doubt, there is a list of licensed establishments on the HTA website or you can contact the HTA directly.

The removal of relevant material from the body of a deceased person and its subsequent storage for use for a scheduled purpose can only take place on premises licensed by the HTA. However, there are some exemptions.

  1. Under Section 39, relevant material which is stored for criminal justice purposes is exempt from the licensing provisions of the HT Act.  Criminal justice purposes are the prevention or detection of crime or the conduct of a prosecution.
  2. Under the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006, storage of relevant material from the body of a deceased person is excepted from licensing where it has (a) come from licensed premises, (b) is being stored for analysis for a scheduled purpose other than research and (c) will be returned to licensed premises when the analysis is complete.

This means that storage of relevant material for toxicological analysis by a specialist laboratory does not require an HTA licence if the above requirements are met, or if the material is disposed of during or after analysis. This exemption should not be taken as an authorisation for the long term storage of relevant material without an HTA licence. Laboratories should endeavour to carry out analyses promptly and to inform the police/Coroner of the results without undue delay.

Note that removal of relevant material from a deceased person for criminal justice purposes, or under the authority of a Coroner, does not require consent. However, once police or coronial authority ends, valid consent from a person in a qualifying relationship with the deceased is needed to store or use relevant material for use for a scheduled purpose.

There are 12 scheduled purposes described in Schedule 1 of the HT Act. The scheduled purpose which relates to research is ‘Research in connection with disorders, or the functioning, of the human body’.

The revised guidance clarifies the practices that should already be in place to undertake removal of regenerative material within the law, and put the donor’s best interests at the forefront of any decision.  

Key issues to be aware of:

  • The person giving consent (in cases where the donor is a child) must have parental responsibility for the child donor and the HTA will need to be assured that this is the case
  • A capacity/competence assessment must be carried out on all child donors, except where it is clear the donor lacks competence, for example, if the donor is a very young/pre-verbal child
  • The referral letter must confirm that the clinician with responsibility for the donor has had a conversation with the person consenting on behalf of the donor, about how they have considered the best interests of the donor in their decision. The letter must also confirm that the clinician is satisfied that the donation is in the best interests of the donor.
  • It is important to continue to explain the role of HTA to families and provide the HTA leaflet ‘Our role in bone marrow and peripheral blood stem cell donation’ available on the HTA website

Yes. Women undergo termination for many reasons and they should not be excluded from the range of options offered to women suffering pregnancy loss. Therefore, the guidance should be adopted by abortion clinics as well as hospitals.

This is correct. The medical certificate of cause of death is the permanent legal record of the fact of death and is a pre-requisite to brain donation for research. Brain banks encourage patients who are on an ‘end of life care’ pathway and their families to remind their doctor that arrangements have been made for brain donation, to help avoid delays at the time of death.

The police have the power to seize relevant material as evidence, including material which is held under the authority of the Coroner. When the police have completed their investigations, relevant material that was seized for criminal justice purposes may come under the authority of the Coroner. The use of two different systems for the retention of relevant material can lead to confusion. In particular, it can be very distressing for families to find out that samples were kept without their knowledge by the police. One solution is for all relevant material to be held under police powers and for the police Family Liaison Officer to liaise with families about the samples. However, this is a matter to be agreed between the police and the Coroner. Further information is available from the Forensic Science Regulator.

There are specific circumstances when you can carry out procurement under a third party agreement rather than a licence. In order to carry out procurement under a third party agreement you must:

If you are procuring tissues or cells on behalf of a patient at your own establishment you cannot do this under a third party agreement with another licensed establishment; this is because you are procuring on your own behalf not on behalf of the licensed establishment. In this case a licence for procurement would be needed.

Research tissue banks storing relevant material ordinarily require a storage licence from the HTA. Those storing other material (e.g. serum, DNA, cell lines) do not. As the HT Act, and the remit of the HTA, applies only to England, Wales and Northern Ireland, research tissue banks based in Scotland do not need a HTA licence.

Extensive legal advice has enabled the HTA to provide up to date guidance on the role and responsibilities of the AA.

Key issues to be aware of:

  • AAs must explore with the person consenting on the donor’s behalf that the decision to consent has been made in the best interests of the donor (explained further in the guidance document).
  • AAs are reminded that separate interviews must be carried out with the donor, recipient and with the person consenting on the donor’s behalf (the detail of what is required from each interview and how to overcome communication difficulties can be found in the guidance document).

It should be noted that crematoria will not accept unidentifiable fetal remains as there is no record of the consent of the woman. For these remains, sensitive incineration is the only disposal option.

Where women choose to donate their fetal tissue for research, they should be informed as part of the consent process what the mode of disposal will be, where this is known, whether any options will be available in that regard and whether the woman will be able to change her mind at a later date. Where options are available, the woman’s wishes should be recorded in order that they can be acted upon when the time comes.

There is no legal or HTA requirement for the death to be registered and the certification of burial of cremation to be obtained before tissue removal takes place. Insistence on the green form (or ‘body release forms’) can lead to donations having to be declined and valuable research tissue being wasted. Provided there is evidence of consent, mortuary staff can be reassured that they are not acting unlawfully by proceeding without a green form.

The Forensic Science Regulator and the HTA recommend that the pathologist creates a single list detailing all samples retained at post mortem examination and under whose authority each was retained. The list should be provided to both the police and the Coroner. A record of traceability of each item should be maintained, showing if relevant material has been returned to the body or to the family, or sent elsewhere for further investigation, for example a toxicology laboratory.

Specialist laboratories should keep detailed records of the samples received from, and returned to, licensed establishments, or disposed of, to maintain traceability. Laboratories may wish to periodically audit relevant material in their possession and confirm with the pathologist/licensed establishment whether police or coronial authority is ongoing, or if further analysis is required. This will help to prevent relevant material being retained unnecessarily, and without consent.

Procurement of tissue for human application, such as bone, skin, heart valves and corneas requires a licence for procurement from the HTA under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended). There are circumstances where a procurement licence is not required and these are set out below:

 

Some research tissue banks act as co-ordinating bodies for organisations, facilitating access of tissue, including tissue which can be imported for use. These can include commercial organisations and pathology ‘networks’.

Yes. You will be sent details of an online refresher package on Monday 1 June 2015 that will need to be completed by all Accredited Assessors by Monday 22 June 2015 in order to maintain accreditation. Please contact us for further information or if you have concerns that the deadline cannot be met.

The online refresher package will be based on information in the new guidance document.

The guidance sets out that women should be given choices and that their wishes should be acted upon. Cremation and burial are the default methods of disposal. If hospitals have effective systems in place that involve consultation with the woman and minimise the use of incineration as a mode of disposal, these are in keeping with the spirit of the guidance. Note that crematoria are unlikely to accept remains that do not contain fetal tissue.

Although the guidance refers to pregnancy remains rather than fetal tissue, hospitals may make a distinction when disposing of remains in circumstances where the woman prefers to leave the decision to them. For example, they may consider the gestation of the pregnancy. Usual practice is for fetuses to be cremated or buried rather than incinerated.

Pregnancy remains at gestations not exceeding 24 weeks are not subject to the provisions of the Cremation Act or Regulations. Although it is at their discretion, most crematoria are prepared to cremate them (see question below relating to the use of consent forms). Guidance from the Institute of Cemetery and Crematorium Management gives helpful advice (PDF) on agreements hospitals should have with burial and/or cremation authorities and other issues such as the packaging of pregnancy remains in readiness for burial/cremation.

Most brain banks require the donation to be retrieved within 48 hours of death, as the preservation of the brain suffers if the time from death to donation from death is prolonged. Donations are most often delayed by concerns over whether a “green form” is required, or whether the death needs to be registered. As stated above the “green form” does not need to be completed and, the death does not need to be registered before a donation can be retrieved.

The specialist laboratory should be made aware if the family has requested that relevant material be returned to them, in order that it can be sent back to the licensed establishment for the family’s wishes to be acted upon. This communication may be from the coroner’s office, the police or, in some cases, the pathologist/licensed establishment. Efforts should be made to return the material without delay.

A licence for the removal of relevant material from a deceased person authorises an establishment to remove material for purposes such as research. It does not authorise the procurement of tissues and / or cells for human application.

Yes, unless the exceptions under the HT Act and associated legislation apply. These are:

  • Storing and providing relevant material which is an ‘existing holding’.
  • Storing and providing relevant material which has been obtained from living donors, the researcher is not in possession, and not likely to come into possession, of information that identifies the donor (‘non-identifiable information’) and the material is released by a research tissue bank with generic approval by a ‘recognised Research Ethics Committee (REC)’ for research within the terms of the approval or it is to be used for a specific research project approved by such a REC.
  • Storing and providing ‘imported’ material (import into England, Wales or Northern Ireland from a place outside England, Wales and Northern Ireland).
  • Storing and providing relevant material which has been donated for research and more than 100 years have elapsed since the person’s death.

The changes will be reflected in an updated portal form which will come into effect on 29 June 2015.

The portal reporting form will better reflect the information the HTA requires in order to make a decision on a case. There will be the opportunity at the end of the portal form for AAs to upload a copy of the referral letter that the HTA must receive.

If the online system is unavailable, an updated contingency form will be available on the HTA website from Monday 29 June 2015

Yes. Where the hospital’s practice is to bury/cremate remains together, the woman should be informed of this when she chooses one of these options. It should be noted that not all Cremation Authorities will agree to carry out communal or shared cremations.

Where the death is violent or unnatural, or is sudden but the cause is unknown, it requires referral to the coroner; in such cases, provided the coroner does not object, the retrieval can go ahead. In coming to a decision, the coroner will have consulted with the pathologist who has been directed in the case. Whilst we understand that mortuary staff may have concerns about the possible later involvement of a coroner, no tissue is destroyed during the retrieval or preservation of the brain, which can be examined at a later date if there is a need for a coronial post-mortem examination.

Once coronial authority has ended, storage of relevant material from a deceased person for use for a scheduled purpose requires the consent of: the person concerned (if they made a decision before they died), or their nominated representative (the HT Act sets out the terms for valid appointment of a nominated representative) or, in the absence of either of the above, a person in a qualifying relationship with the deceased when they died.

Consent must be obtained from the person ranked highest in the hierarchy and is only needed from one person in the hierarchy. The hierarchy of qualifying relationships follows this descending order:

  1. spouse or partner (including civil or same sex partner)
  2. parent or child
  3. brother or sister
  4. grandparent or grandchild
  5. niece or nephew
  6. stepfather or stepmother
  7. half-brother or half-sister
  8. friend of long standing

This person may be different from the next of kin or personal representative whom the Coroner notified that relevant material has been retained, and to whom the options for dealing with it on expiry of the retention period must be communicated. The Designated Individual of the establishment where the relevant material is stored needs to be assured there is appropriate consent under the HT Act for storage and use of the sample(s) for a scheduled purpose.

A third party agreement is an agreement in writing between a Licence Holder (LH) or Designated Individual (DI) and another person that carries out a licensable activity on behalf of the LH / DI. The agreement needs to be made in accordance standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA's Directions 002/2018. If the licensable activity is carried out under a third party agreement as described above, the organisation carrying out that activity will not require a licence.

If practicable, the consent of a research donor should be sought wherever possible and the views of the relatives of a deceased person must be respected. 

For imported material, there should be mechanisms in place to provide assurance that the tissue has been obtained in the source country with valid consent. The importer should have in place, policies and/or standard operating procedures which clearly set out the evidence indicating how informed consent was obtained, including safeguarding the confidentiality of all information relating to consent. If a separate organisation is importing the material, a documented agreement should be in place demonstrating that there is a record of consent in a suitable format.
 

No, placentae can be disposed of as clinical waste in line with the hospital’s usual procedure.

There are no time limits for which signed consent forms remain valid and there are no legal requirements for the format of consent forms. There is no need to ask for new forms to be signed if consent was written down by the donor several years before he or she died. In the unlikely event that you have reason to believe that the person changed his or her mind since documenting consent, the retrieval should not go ahead and the brain bank should be informed.

Disposal of relevant material does not need to take place on HTA-licensed premises. By agreement with the licensed establishment, relevant material may be disposed of by the laboratory where it was analysed. Such an arrangement should be documented in a written agreement. Records of disposal (date, reason and method) should be maintained to ensure traceability.

Further information about disposal of relevant material can be found in our codes of practice.

Premises where relevant material is being stored while disposal instructions are being awaited from the Coroner or the police do not require a licence from the HTA.

The following licensable activities can take place under a third party agreement: procurement, testing, processing, distribution and export. The activities of import and storage cannot take place under a third party agreement.

Specific consent is given in relation to a defined project, treatment and/or use.

Broad (generic) refers to consent given to allow the storage and use of tissue for an as yet unknown research project or as part of a research tissue bank. 
Specific and broad consent may be sought at the same time, to derive the greatest benefit from valuable human tissue donated for research.

Women may miscarry naturally or pass the pregnancy by medical induction outside of a clinical facility. The woman may choose to dispose of the pregnancy remains herself, and in such circumstances advice on how to manage this appropriately should be available from service providers such as termination services or early pregnancy units. Some women will need to retain the pregnancy remains for histological examination, or would prefer to have the remains disposed of by a clinical facility, and consideration should be given as to how this can be facilitated.

Paramedics should be aware of the guidance in the event that they are called to assist.

The brain bank consent form contains all relevant permission and information required to carry out the retrieval of the brain and to use it for research. The completion of an additional hospital PM form is not necessary. If consent has also been given for a hospital post-mortem examination, consent for removal of the brain and its use for research can be recorded on the hospital consent form and an additional brain bank consent form is not required.

Our Code of practice on Disposal provides detailed information on the disposal of relevant material which pre-dates the HT Act (‘existing holdings’). In relation to samples which should have been disposed of, but have not been, the HTA can be contacted to provide advice.

The types of research for which the tissue will be used should be explained, along with the circumstances under which the tissue will be disposed of.

If the tissue donated will be identifiable, the donor should be informed if they will be contacted by researchers, given feedback, or be asked for access to their medical records.

If a research tissue bank intends to charge for providing human tissue samples to researchers (including those working for private companies) this should be made clear to donors. The research tissue bank should also provide information about how and why they charge, and to whom they will supply the human tissue samples.

If a donor expresses objections to specific types of research, these must be respected.

The criteria for obtaining valid broad consent from research tissue bank donors can be considered in light of the six ‘key tests’ set out in the joint HRA/HTA report, ‘Consent to use human tissue and linked health data in health research: A Public Dialogue for Health Research Authority and Human Tissue Authority’.

There is no legal bar to women taking their pregnancy remains home with them for disposal, although there are certain requirements that need to be met.  The women should be advised to think carefully about what she will do with the remains and consider any associated restrictions which might exist, for example in relation to burial on a home property.

You are under no obligation to help brain research. However, brain banks rely on the assistance and good will of mortuaries throughout the country to be able to fulfil the wishes of donors and their relatives, and to provide researchers with essential human tissue for research. Most brain banks are able to pay a small fee to cover costs. Please let the brain bank know if your hospital has a policy of not allowing its mortuary staff to retrieve tissue for research, so that the brain bank can contact the Chief Executive to discuss this. If you think you do not have the necessary equipment to enable you to undertake brain and spinal cord retrieval, the brain bank may be able to assist.

Our current licence fee for procurement organisations can be found here.

Not always but broad consent may avoid the need to seek further consent and this avoids a situation where a valuable tissue resource cannot be used for research in the future.

Yes. Burial in a garden or other private land is not unlawful, provided that the person carrying out the burial owns the freehold or has obtained consent from the owner of the freehold.  More advice on the burial of pregnancy remains at home can be obtained from the ICCM.

The Natural Death Centre's guide on home burial covers information on essential regulations that should be followed, planning permission, the role of the local authority and grave digging.

Please let the brain bank know if your hospital has a policy of not allowing its mortuary staff to retrieve tissue for research, so that the brain bank can contact the Chief Executive to discuss this.

The HTA will send an invoice with your licence offer. This invoice will cover the period from the date that a licence is issued, extending up until the following 4 July. Thereafter you will normally be charged annually.

Please contact our licensing team if you have further queries.

No, applications are voluntary but REC approval may facilitate programmes of research without a need for individual project-specific REC approval. The RECs: (i) are a source of ethical advice to the research tissue bank on its arrangements for collecting, managing and distributing tissue; and (ii) can advise on informed consent and procedures for providing feedback to donors. Ethical approval for a research tissue bank also offers additional assurance to end user researchers, donors and the public that its operations meet the highest ethical standards.

The guidance sets out that the woman’s medical notes should record whether information was provided and what the woman’s decision was, and that a record should be kept of the date and location of the disposal. This is to ensure an audit trail for the disposed of remains, should the woman make enquiries at a later date. As the cremation or burial of pregnancy remains fall outside the scope of legislation in this area, there are no legal requirements in relation to consent and therefore the guidance does not specify that a consent form for the disposal is required. What is important is that sensitive discussion takes place, that a record of this happening is made, and that the date and location of the disposal are recorded, so that a record exists should a woman wish to trace the disposal of her pregnancy remains in the future.

Brain banks and researchers understand that mortuary staff have a busy job but rely on your good will to be able to carry out their work and provide families with the opportunity to support research. Brain retrieval can be carried out in approximately 30 minutes and brain bank staff are always happy to provide guidance and training. They are happy to discuss this further or to agree the terms under which brain retrieval can take place.

It is possible for procurement sites to be satellite sites of a licensed establishment. Satellite establishments are normally smaller premises on a separate site to the licensed establishment. The satellite establishment must be under the same governance framework as the larger licensed establishment (the hub) and supervised by the same Designated Individual (DI). The DI at the hub must have systems in place to ensure that the governance framework is properly implemented. The DI should plan to make regular visits to satellites to verify that the licensing framework and systems and processes are working in practice.

For researchers working in NHS Scotland, it is expected that one of the four Healthcare Improvement Scotland-accredited Scottish Health Board research tissue banks will be used. 

The HTA’s remit does not cover REC-approved research tissue banks in Scotland.

Tissue samples from early pregnancy loss may be sent to Histopathology for examination to identify any unusual pathology and aid diagnosis. These can be considered part of the woman’s diagnostic record and do not need to be disposed of in line with this guidance.

The brain bank involved will collect the tissue or arrange collection by a reputable courier and transfer it to their premises for processing and diagnosis. They will inform the family the donation has gone ahead and will handle all further correspondence. They will arrange collection of the body by the family funeral director if necessary and organise any agreed payments to the mortuary staff.

Any activity carried out under an HTA licence needs to be under the supervision of a DI. If you wish to carry out the activity of procurement at an organisation that is already licensed by the HTA you will need to contact the DI and ensure that they are willing and able to supervise the activity.

Please note, it is a standard condition of licences issued in the HA sector that:

“Where a new type of tissues and/or cells is to be procured, tested, processed, stored, distributed, imported or exported by the establishment, or under a third party agreement, the Designated Individual must first notify the HTA and the new type of tissues and/or cells may not be procured, tested, processed, stored, distributed, imported or exported by the establishment (or the third party) until the HTA is satisfied that the establishment has suitable premises and employs suitable practices to carry out the proposed activity in respect of these tissues and/or cells.

With this in mind, if you wish to procure a new type of tissue or cells under the authority of an existing HTA licence, the DI should notify the HTA prior to this activity commencing.

RECs will normally only review research tissue bank applications from organisations within the UK. Applications from outside the UK are only accepted for review if the research tissue bank plans to collect biological samples relating to UK donors. 

Service providers that are involved with the disposal of pregnancy remains should self-assess and monitor their compliance with this guidance through regular audit of relevant policies, procedures and women’s medical records.

The CQC may consider compliance with this guidance as part of its ongoing monitoring and during inspection of registered providers of maternity and family planning services and termination of pregnancy services. The CQC makes judgements about these type of services in respect of whether they are safe, effective, caring, responsive and well led, and publishes its findings.

During inspection of HTA-licensed premises that are involved with the disposal of pregnancy remains, HTA will check the establishment’s compliance with the guidance and provide advice and guidance where shortfalls are identified.

The vast majority of mortuaries have a licence which allows them to store human tissue for a purpose such as research. Brain banks normally allow about two weeks before collecting a brain so that it is fully fixed before transport, but if this is problematic for any reason, brain banks can arrange for earlier collections.

The application is made through the Integrated Research Application System (IRAS) by selecting the research tissue bank category. If the research tissue bank will be storing relevant material then the details of the Designated Individual (DI) are required, along with a copy of the licence certificate. The research tissue bank needs to be licensed as some of the human tissue being stored will not be for use in specific REC-approved projects.

Designated Individuals should contribute to the development of policies and procedures on the disposal of pregnancy remains, where they are handled on HTA licensed premises. However, the DI’s statutory responsibility to ensure that suitable practices are taking place under the licence does not extend to the activity of disposal of pregnancy remains that have not been removed, stored or used for a scheduled purpose.

It is a requirement that the DI must have:

  • a diploma, certificate or other evidence of formal qualification in the fields of medical or biological sciences; or
  • be otherwise considered by the Authority to be suitably qualified on the basis of academic qualifications and practical experience; and
  • have at least two years' practical experience which is directly relevant to the activity to be authorised by the licence.

    An HTA licence, when required, can be applied for at the same time as applying for ethical review or afterwards. However, if relevant material is being stored in the research tissue bank, the bank will not be allowed to operate until the required HTA licence arrangements have been confirmed.

    The guidance does not apply to the disposal of embryos created in vitro (for fertility treatment or embryo research), which is regulated by the Human Fertilisation and Embryology Authority (HFEA). As set out in its Code of Practice the HFEA requires centres to take account of the special status of the human embryo when the development of an embryo is to be brought to an end. Terminating the development of embryos and disposing of the remaining material should be approached with appropriate sensitivity, having regard to the interests of the gamete providers and anyone for whose treatment the embryos were being kept.

    The LH has the right to vary a licence. This enables them to substitute another person as the Designated Individual (DI) and allows the establishment to cover circumstances where the DI is unable or incapable of overseeing the licensable activities. Consequently, the HTA requires individual LH to be more senior than the DI (e.g. Medical Director / Chief Executive).

    Where the LH is a corporate body, establishments should provide contact details of an individual who will act as a representative for the corporate body. This individual should also be more senior than the DI in order to substitute the DI where necessary. The HTA has a preference for LHs to be a corporate body.

    The ethical review applies to the management of the research tissue bank as a whole, including arrangements made with collaborators. There is no requirement for individual research sites involved in human tissue collection (‘Tissue Collection Centres’) or storage to apply for ethical approval.

    There are, however, licensing implications for Tissue Collection Centres (see below).

    The research tissue bank’s ethical approval also extends to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored on HTA-licensed premises for the duration of the project and does not need project-specific REC approval.

    If the research is not carried out in accordance with these requirements, a project-specific REC application will be required or the samples will need to be stored under a separate HTA licence.
     

    It is possible for a licence to cover all procurement activities carried out within a Trust. However if tissues or cells are procured on multiple sites within the same Trust, the HTA should be contacted to see if a hub-satellite licensing arrangement is needed.

    Approval is given for a period of five years, which may be renewed (for further periods of five years) following submission and review of a renewal application to the REC. 

    No. An application for a licence must specify the premises where the licensed activity is to take place. If the licensed activity will take place in premises at more than one place, a separate licence will be needed. Premises in different streets or with different post codes will be considered as being in different places. In contrast, different buildings on a hospital site could be regarded as in the same place. The HTA will consider this on a case-by-case basis, depending on the facts in each application.

    Yes, an annual report must be provided to the REC. The annual report summarises the research work of the research tissue bank, publications, updated protocols, applications to the research tissue bank and traceability of tissue being distributed from the research tissue bank.

    Yes. However, standard condition 14 in Annex B to all HTA licences, requires the Licence Holder or the Designated Individual (DI) to notify the HTA when any new type of tissues and /or cells is to be procured, tested, processed, stored, distributed, imported or exported by the establishment. Where the processes required for this new type of tissues or cells differ substantially from those previously employed by the establishment, the DI must first notify the HTA. The new type of tissues and /or cells may not be procured, tested, processed, stored, distributed, imported or exported by the establishment until the HTA is satisfied that the establishment has suitable premises and employs suitable practices to carry out the proposed activity in respect of these tissues and /or cells.

    All activities carried out under the licence must be supervised by the DI, and the DI must have suitable qualifications and experience to supervise the complete range of tissue types covered by the licence.

    Yes. The application should include information about each collection, including policies for access to tissue in each collection and distribution to external researchers.

    Alternatively, the applicant can submit a separate application for each research tissue bank. 

    No. A separate application should be made for each licensed research tissue bank, even if the DI is the same on both licences.

    Yes. Organisations procuring tissues and cells for human application require a licence from the HTA unless procurement is being carried out under a third party agreement. In these circumstances:

    The management arrangements should ensure that each research application is subject to scientific critique, is appropriately designed in relation to its objectives and is likely to add something useful to existing knowledge.

    Applications to the research tissue bank and decisions on release of tissue to researchers may be considered by an ‘access committee’, usually of senior academics and lay people. This ensures that release of tissue is in line with the terms of the consent given (see below).

    In the UK, procurement of tissues and cells for human application is licensed under The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) which were transcribed into UK law from the European Union Tissues and Cells Directives (EUTCD).

    The latter is legislation that is applicable to all countries in the European Union with each country having its own Competent Authority responsible for the licensing of procurement organisations. Hence, any organisations that procure tissue for human application in Europe will be subject to the EUTCD and will require a licence from the national Competent Authority, rather than the HTA.

    Where samples have been donated with broad consent, the research tissue bank must be satisfied that the use of the samples complies with the terms of donor consent.

    Samples and any associated clinical information must be non-identifiable to the researcher at the point of release.

    A supply agreement must be in place with the researcher to ensure storage, use and disposal (or return) of the human tissue samples in accordance with the terms of the research tissue bank’s ethical approval. 
     

    If the researcher wishes to use identifiable clinical information on the samples they have received, they must apply have project-specific REC approval. The research tissue bank’s consent form and participant information leaflet must meet the requirements of the General Data Protection Regulation (GDPR) and the Data Protection Act (2018).

    The research application should be submitted to the REC which approved the research tissue bank application.

    Yes. The research tissue bank should make this clear to the donor and should also provide information about how it charges, and to whom they will supply the human tissue samples.

    No, in some research tissue banks the human tissue is taken out by multiple users almost immediately because of the nature of their work (e.g. fresh tissue is required). There are other research tissue banks which are accessible only to the staff of the company. 

    Yes, but the samples must be stored on HTA-licensed premises unless a storage licensing exemption applies (e.g. the research will be carried out under project-specific REC approval).

    On completion of such research, the researcher must choose the most appropriate option:

    • transfer the human tissue back to the research tissue bank.
    • transfer the human tissue to an alternative HTA-licensed establishment.
    • apply for their own HTA licence (unless the further storage can be covered by an existing local licence).
    • apply for specific project approval by a REC.
    • dispose of the human tissue.

    Samples used for diagnosis may be stored in an archive to benefit the person’s medical care. These samples can also be valuable resources for health research. Purely diagnostic archives do not need to be stored on HTA-licensed premises as no licensable activity would be taking place. However, the HT Act clearly provides that the storage of tissue for a ‘scheduled purpose' must be on licensed premises.

    The material is usually in the form of formalin-fixed, paraffin-wax embedded (FFPWE) blocks and sections cut from these blocks on glass slides. The archive may also contain frozen tissue and frozen tissue sections. 
     

    If a diagnostic archive releases tissue for research occasionally upon request, its status as a diagnostic archive remains clear and it doesn’t need to be covered by a HTA storage licence. If there is an expectation that tissue will be released on a regular basis, then it may cease to be a purely diagnostic archive, particularly where there are developed governance / decision-making structures and procedures for applying for tissue.

    If the archive functions as a resource for researchers (by inviting applications for the release of samples or advertising the archive as a research resource), it is functioning as a research tissue bank and needs to be covered by a HTA storage licence. 

    Not necessarily. If the diagnostic archive is based on premises already licensed by the HTA for storage (e.g. under an Anatomy, Human Application or Post-Mortem licence), providing the DI is willing to take responsibility for the governance of the archive, the existing licence can be extended in anticipation of the archive operating as a research tissue bank.

    Where the archive is on premises not licensed by the HTA for storage, a new licence application will need to be submitted prior to the archive operating as a research tissue bank.
     

    The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) define a third party agreement (TPA) as:

    “An agreement in writing between a licence holder (or the designated individual on behalf of the licence holder) and another person, which is made in accordance with any directions given by the Authority under section 23(1) of the 2004 Act for the purpose of securing compliance with the requirements of Article 24 of the first Directive (relations between tissue establishments and third parties), and under which the other person:

    (a) carries on licensed activity (other than storage or import into the United Kingdom from a third country) on behalf of the licence holder; or
    (b) supplies to the licence holder any goods or services which may affect the quality or safety of tissue or cells.

    A service level agreement (SLA) is an agreement that sets out the roles and responsibilities of two parties. An SLA cannot be used to provide a third party with the authority to undertake licensable activities on behalf of a licensed establishment, and is not sufficient for governing the supply of goods or services which may affect the quality or safety of tissues and cells.

    If two establishments are licensed by the HTA and one undertakes licensable activities on behalf of the other, an SLA setting out roles and responsibilities is sufficient to document the working relationship between the two licensed establishments.

    Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended), relevant third party premises in relation to a licence under Schedule 1, mean any premises (other than premises to which the licence relates):

    • on which a third party procures, tests, processes or distributes, or from which a third party exports from the United Kingdom to a third country, tissue or cells on behalf of any person authorised by a licence to carry on that activity; or
       
    • from which a third party provides any goods or services which may affect the quality or safety of tissue or cells to any person in connection with licensed activities carried on by that person; and
       
    • ‘third party’ means a person with whom a licence holder has a third party agreement.

    No. Storage or import of tissue and cells cannot be undertaken by a third party under a third party agreement. All other licensable activities can be; however, all the activities must be specifically described in the agreement and must be authorised by the licensed establishment’s licence.

    No. A third party agreement (TPA) is defined as being between an establishment and another person (including corporate entity) i.e. between two distinct legal entities. If an NHS Trust is the Licence Holder (LH), it cannot have a contractual agreement in place with itself, even if such agreement would be on behalf of another hospital in the same Trust.

    When licensed activities are carried out by a third party within the same NHS Trust, the LH could consider putting individual TPAs in place with third party staff, if the licensable activity is to be carried out by an individual or applying for a satellite licence.

    The full requirements for TPAs are set down in paragraphs 238-239 of the Guide

    Regarding paragraph 239 b(vii), Licence Holders and Designated Individuals should ensure that Third Party Agreements include specific instructions relating to the reporting time frames for serious adverse events and reactions (SAEARs); more information on this can be found in paragraph 217 of the Guide. 

    The full requirements for DIs are set down in paragraphs 1-4 of the Guide and specific requirements for the DI pertaining to TPAs are set down in paragraphs 234-235 of the Guide.

    • ongoing audits of the procedures, facilities and personnel;
    • risk assessments of the premises and activities being carried out under the licence;
    • periodic review of the TPA to ensure it remains fit for purpose;
    • provision of a pro forma for risk assessing risks that may arise on an ad hoc basis;
    • ongoing review of SOPs for maintenance of premises and facilities;
    • ensure controlled access and security measures;
    • ensure that appropriate back-up and emergency clinical facilities (if appropriate) are in place;
    • review environmental monitoring, air quality and other critical processing parameters; and
    • provide and / or review the appropriateness of garments and equipment for personal protection and hygiene.

    Yes. In addition, the DI must be allowed access to the facilities, RTPPs, documentation and records, including audit of the premises and practices of the TP. This will allow the DI to ensure that suitable practices are being carried out and that the conditions of TPAs are being complied with.

    DIs should also be aware of their specific duties under Regulation 12 of the Human Tissue (Quality & Safety for Human Application) Regulations 2007 and the provision to conduct audits of third party premises at two yearly intervals as set down in the Guide.

    The reporting requirements relating to third parties carrying out licensable activities under the terms of a third party agreement are set out in paragraphs 232-235 of the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.

    It is a standard condition of HTA human application licences that where a third party agreement is entered into by the Licence Holder, or the Designated Individual on behalf of the Licence Holder following the grant of a licence, then the Licence Holder, or the Designated Individual must first notify the HTA and the HTA must be satisfied as to the suitability of the proposed relevant third party premises before any licensed activity is carried out by the third party on behalf of the Licence Holder.

    The HTA’s TPA submission form should be used to notify the HTA of new third party agreements.

    Records must:

    • comply with Standard Operating Procedures (SOPs) for records management. These SOPs should be provided to the third party by the Designated Individuals of the licensed establishment;
    • be intact, complete and legible;
    • facilitate traceability from donation to end use;
    • be stored securely;
    • remain confidential (restricted access);
    • provide for execution of duties in relation to disclosure of information (as per the Regulations); and
    • be retained / maintained in line with reported activities taking place under a third party agreement as part of an annual activity report to the HTA.

    All documentation and records to facilitate the traceability of donors must be retained for 30 years after the cells are used or disposed of. This includes donor identification, product identification, identification of the supplier establishment clinician or end user, tissue / cell type, date of application, identification of the recipient.

    All records, including raw data, critical to activities that may affect the quality and safety of tissues and cells must be retained for 10 years after use or disposal of the cells. Provisions must be in place in any TPA to ensure that records are transferred to a licensed establishment in the event of termination of activities.

    The third party agreement (TPA) must include provision of the transfer of any tissues and cells and there also be a documented process for the transfer of records from the third party to the licensed establishment. (paragraphs 267-270 of the Guide).

    It is the responsibility of the Designated Individual of the licensed establishment to communicate information to third parties, including regulatory alerts and other relevant communications from the HTA regarding serious adverse events and reactions (SAEARs).

    The requirements and procedures for reporting adverse events and reactions that occur at third parties should be clearly documented. This may be achieved though the inclusion of detailed information on incident reporting in third party agreements, or through the sharing of standard operating procedures (SOPs) for incident reporting that have been generated, and are controlled by, the licensed establishment. If the latter approach is adopted, the relevant SOPs should be clearly referenced within the third party agreement. 

    The Designated Individual (DI) of the licensed establishment is responsible for assessment and documentation of the adverse incident occurring under the licence, and reporting of any serious adverse event or reaction to the HTA and any other affected establishments.

    The DI should:

    • assess the seriousness of the incident;
    • investigate the incident;
    • document the reporting, assessment, evaluation and investigation of the incident;
    • retain all documentation related to investigation of the incident;
    • if deemed serious, notify and report the adverse event or reaction to the HTA and to personnel within the establishment and other establishments; and
    • if appropriate, recall the implicated tissues and / or cells.

    The establishment and the third party must make available to the HTA (on request) all records related to a SAEAR and aid in any investigation process. This process must be clearly specified in the third party agreement. The Designated Individual should also ensure the retention of records related to the SAEAR, including any follow up reports.

    Our intention in extending the publication scheme is to be more transparent about the regulatory action we take. This is in the public interest. We want to maintain and enhance the confidence of the public, on whose behalf we regulate. An establishment that is inspected has the benefit of the advice and assessment of the HTA inspection team. Publication of the inspection report allows other stakeholders to have the benefit of this information as well. This will help raise standards and improve performance against the regulatory requirements because stakeholders will be able to use the information in the reports to identify shortfalls with regulatory requirements themselves. (Back to top)

    Yes. The HTA and other health regulators are required to comply with the MacRory report (“Regulatory Justice: Making Sanctions Effective” – Professor Richard MacRory). The MacRory report requires that regulators who undertake enforcement actions do so in a transparent way.

    The rationale for Macrory’s recommendations is that regulators should be more accountable to those they regulate and to those on whose behalf they are regulating.

    Some establishments in our remit need to hold a HTA licence to carry out their work. We assess these establishments against regulatory requirements when they first apply to the HTA for a licence and then we inspect the establishment on a site visit to check the regulatory requirements have been met.

    For establishments in the human application sector, the Human Tissue (Quality and Safety for Human Application) Regulations 2007 requires an inspection to be conducted every two years.

    As part of the inspection process, the HTA inspection team works with staff in the establishment to help them meet standards. Where there are shortfalls with our standards Designated Individuals (DIs) are asked to work with the HTA to agree how they will address identified shortfalls.

    Inspections are scheduled based on risk. Regulation managers use their professional judgement and assess information. We calculate risk each time we are in receipt of information about an establishment in our remit (e.g. after receiving a licence application or after previous inspections). The risk we refer to here is regulatory risk, which is the risk of our standards not being met or legal and regulatory requirements not being adhere to.

    Where the HTA determines that a licensing standard is not met, the improvements required are stated and the level of the shortfall is classified as ‘Critical’, ‘Major’ or ‘Minor’.

    If we identify a minor or major shortfall then we ask the establishment to identify the measures that need to be taken to address these shortfalls and document this in a corrective and preventative action plan (CAPA). Alternatively, for example where critical shortfalls are identified we may inform an establishment about actions which must be taken immediately. We do this by issuing legal orders called ‘directions’ which usually require an establishment to take action with immediate effect from the date the special directions come into force. We require confirmation that action has been taken by the date we specify and establishments that fail to do so may risk more serious regulatory action such as suspension or revocation of an HTA licence. In other cases of critical shortfalls, we consider what other action may be taken, including adding conditions to the licence or even suspending or revoking the licence.

    Directions require the DI and Licence Holder to improve ways of working so that standards are met. It is mandatory for these directions to be followed straightaway.

    Inspection reports detail background information about the activities the establishment is carrying out and an indication of any shortfalls in meeting the HTA standards. In addition there are several appendices to the report:

    • appendix 1 outlines the HTA inspection process
    • appendix 2 outlines the classification of the level of shortfall
    • appendix 3 outlines the full set of standards that an establishment has been assessed against

    HTA-licensed establishments are required to meet our standards. The standards fall into four broad categories:

    • consent
    • governance and quality systems
    • premises, facilities and equipment
    • disposal

    The full list of standards is outlined in Appendix 3 of the inspection report.

    When major or minor shortfalls have been identified following the inspection site visit, the establishment will be asked to complete a corrective and preventative action (CAPA) plan which outlines the steps that will be taken to address the shortfalls.

    Yes. Once the report has been drafted it will be sent to Designated Individuals (DIs) and Licence Holders to check for factual accuracy.

    In addition, there will be an opportunity for DIs and Licence Holders to identify information they believe to be commercially sensitive. This will be during the stage of checking the factual accuracy of the inspection report. DIs and Licence Holders will be asked to provide reasons for why they believe the information to be commercially sensitive. The HTA will make a final decision on whether to redact or not based on principles within the FOI Act.

    Prior to the introduction of PPDs, we found significant variability in establishments understanding of what is required to validate preparation processes satisfactorily. The PPD aids clarity as it sets out a format for the information you will need to collect, and will help you fill any gaps in your validation. The common format contributes to ensuring that the HTA’s review process is conducted efficiently and consistently.

    New licence applications for processing of tissue or cells for human application must include a PPD to describe the process validation. Processing of the tissues and cells cannot commence until the processes proposed under a new licence have been authorised. We also require new or modified processes to be authorised. It is a standard condition on all licences that you inform the HTA of any change to your activities. If the changes to your preparation processes might have an impact on the quality or safety of the tissues or cells, then you will be asked to complete a PPD.

    We may ask establishments licensed for processing under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 to complete a PPD prior to a scheduled site-visit inspection, if the processes have not already been authorised through the PPD process. A PPD will generally not be requested if validation of routine and well established processes has been recorded by the HTA during previous inspections.

    Licensing standard GQ2d requires that ‘Processes affecting the quality and safety of tissues and/or cells are validated and undergo regular evaluation’. You may be asked to submit a PPD if a shortfall is recorded against this standard during a site visit inspection.

    As the name implies, PPDs refer only to preparation processes. Procedures used to procure, distribute, store or engraft tissues or cells fall outside the scope of PPDs. Preparation processes include all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human application. Preparation processes do not include activities such as the washing of femoral heads during procurement in an operating theatre.

    In general, packaging and labelling of tissues or cells should be regarded as a stage in the preparation process. There is a specific section of the PPD for you to record labelling and accompanying documentation that must be completed if you are distributing tissues or cells for end use.

    In some cases, tissues and cells used as starting materials for biological medicinal products are processed by establishments under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. One example of this is the processing activity that is carried out to derive early cell lines or banks, prior to establishing a Master Cell Bank. In these cases, you will be required to submit a PPD to the HTA to cover this early stage processing.

    An ATMP (MP or IMP) may contain, or consist of, cells or tissues that have either been subject to ‘substantial manipulation’, or that will not be used for the same essential function(s) in the recipient as in the donor. Under these circumstances, the HTA will regulate the donation, procurement and testing of human tissues and cells. The MHRA will regulate the manufacture, storage and distribution of these products. One example of this is chondrocyte procurement for use in Matrix Induced Chondrocyte Implantation (MACI).

    All PPD submissions are reviewed by the PPD Working Group (PPDWG). Your PPD will be assigned to a Regulation Manager from the PPDWG, who will be your HTA contact throughout the authorisation process. This PPDWG member will review your submission and then present it for consideration at a PPDWG meeting. If the PPDWG require further information, you will receive an email from your PPDWG contact outlining this. Once you have submitted further information, this will be reviewed using the same process.

    We aim to reach a decision on complete PPD submissions within 20 working days of receipt. The approval process may be extended if your submission is incomplete, or if we require further information.

    Where the PPDWG decide that additional information is needed (e.g. further validation studies, submission of additional published data, etc), PPDs will be deemed ‘incomplete’ and you will be informed of this decision within 20 working days. In these cases, the timeline for a decision on the status of your PPD will restart once you have submitted the additional information.

    >PPDs should be authorised by the HTA before you undertake any processing activity. If there is an urgent need for you to begin processing any tissues and cells, then you should inform the HTA at the point of submission.

    Section G on the PPD form provides a space for you to include additional information that the HTA should be aware of with respect to the reviewing and authorisation of your preparation process. For example if there is an urgent clinical need for the tissues or cells covered by the PPD then this should be indicated within this section.

    At the point that your PPD is authorised, you will receive written confirmation from the PPDWG. An authorised preparation process is one which has passed the HTA’s internal due diligence process and for which documentation has been provided by the establishment to demonstrate compliance with the requirements of the EU Tissue and Cells Directive 2006/86/EC Article 4 and Annex II Part B.

    Processes affecting the quality and safety of tissues and cells should undergo regular evaluation to ensure they continue to achieve the intended results. Directions given by the HTA in relation to these requirements are set out in the HTA’s licensing standards and evidence of compliance may be sought as part of any future inspection.

    The authorisation of a preparation process by the HTA does not extend to authorisation of the end use of the tissue or cells. This is a clinical decision which should take into account all relevant scientific and clinical information. The HTA is satisfied that the preparation process does not render the tissues or cells clinically ineffective or harmful to the recipient, but does not have the remit to provide any regulatory assurance that the end use will be of benefit or clinically effective. As such, no tissue establishment may seek to rely on an HTA authorisation of a PPD as providing any such assurance.

    The PPD was an outcome of the European Standards and Training in the Inspection of Tissue Establishments (EUSTITE) project, in which EU Member States and the World Health Organisation recommended its use for the authorisation of processing of tissues and cells. The project included consultation across Europe. Competent Authorities, like the HTA, are expected to implement PPDs after the European Commission decided to adopt this recommendation.

    The HTA introduced the PPD following development with stakeholders in the sector. A series of pilots were conducted as part of routine inspections in a six-month period of the 2011/12 year, during which feedback was sought and improvements were made to make the PPD clearer.

    In May 2013, the HTA held a workshop on PPDs which was attended by 35 delegates from establishments across the UK that process human tissues or cells for human application. The workshop included presentations by members of the HTA’s PPDWG on the regulatory background to PPDs and the PPD submission and review process.

    Workshop attendees also participated in a series of interactive sessions. These aimed to provide clarification on the information that should be submitted to the HTA to evidence the validation of preparation processes, and the occasions when it is necessary for organisations to provide such information.

    Presentations from the workshop are available on the HTA website. Further information on how to write a PPD is available in our guidance document (PDF). If you have any questions about writing a PPD, please contact the HTA by telephoning 0207 269 1900 and ask to talk to a member of the PPDWG.

    Tissue establishments are required to demonstrate that critical tissue and cell processing procedures have been validated to ensure that they do not render the tissues or cells clinically ineffective or harmful to the recipient/patient. There is no requirement for studies demonstrating clinical effectiveness.

    If, however, you choose to base the validation of your processes on a retrospective analysis of clinical outcomes, demonstration of clinical efficacy and safety of the tissues/cells may be used to provide evidence of validation.

    If you are conducting your own validation studies, your preparation process must be shown to deliver tissues or cells with the required properties (Critical Quality Attributes; CQAs) that are necessary to ensure they are not clinically ineffective or harmful. You will define these CQAs depending on the tissues or cells in question, and their function during human application.

    Critical Quality Attributes (CQAs) demonstrate that processing has not rendered the tissue harmful or clinically ineffective. Some examples of CQAs include: sterility (in both processed samples and in the end product); final cell count; sample viability; residual water in freeze dried tissue; and purity (e.g. phenotype of cells).

    Critical Processing Parameters (CPPs) are the conditions that bring about or preserve the CQAs. For example, when freeze-drying acellular pericardium the CPPs of temperature and duration of the process have a critical impact on the CQAs of residual water and stability of the resulting collagen matrix.

    When an establishment is looking to undertake a preparation process that has been established elsewhere, you may be able to use previously published data to evidence that your processing method does not render the cells harmful or clinically ineffective. In such instances, you should submit evidence of how the preparation process will be implemented to equivalent standards in your own facility.

    In situations where suitable material is not available for validation purposes only, we would look to authorise the PPD on the basis of the alternative steps the establishment has taken to ensure the quality and safety of the tissues / cells during the preparation process.

    For example, this could be through the submission of information that demonstrates that the establishment will use well-established protocols/reagents/equipment.

    Where protocols are being transferred from one lab to another, we would look for evidence of training by those experienced in carrying out the technique, and evidence of supervision during the early implementation phase at the new premises.

    We would also look for evidence that the establishment has put in place appropriate quality control checks. In line with this, we would expect establishments to have clear release procedures in place to ensure that samples are not released for clinical use unless the processing has achieved well-defined quality and safety criteria.

    We would additionally expect the establishment to clearly map out how they intend to review the data from the initial processing runs, as part of their on-going operational validation. In situations such as this, our expectation is that this information will be submitted to the HTA for review at the earliest opportunity.

    An assessment will be made by the HTA on a case per case basis and will include a risk analysis encompassing clinical need.

    If the change to an authorised process has the potential to affect the quality and safety of the tissues or cells, then you may be required to submit a PPD for this change of process. A member of the PPDWG will be able to advise you on whether a change of process PPD is required or whether the change can be managed by your own internal change control processes only.

    The information that is submitted in PPDs will be treated by the HTA in confidence; we do not intend to publish PPDs or information extracted from these documents. This is particularly important for those establishments where the information has a commercial value.

    Requests for information may be made under the Freedom of Information Act 2000. Where a request is made to the HTA, and where this relates to an establishment or a person, the HTA will contact that establishment to seek views on whether there are any concerns around release of information. These views are then used by the HTA to decide whether or not to release the information, and if not, the grounds on which it is withheld. Adopting this approach on a case by case basis means that views on what is and what is not to be regarded as commercial interests can be taken on each request.

    Section 43 of the Act has two different qualified exemptions designed to protect commercial interests. The first regards class-based information, which is exempt if it constitutes a trade secret. The second is prejudice-based information, which is exempt if its disclosure under the Act would, or would be likely to, prejudice the commercial interests of any person or organisation.

    More information about PPDs is available in the guidance document (PDF). If you have any questions, please contact the HTA on 0207 269 1900 and ask to talk to a member of the PPDWG.

    Establishments are required to notify the HTA of serious adverse events (SAEs) or serious adverse reactions (SARs) within 24 hours of discovery. Establishments should take note that a full investigation of an event or reaction is not required for the purposes of initial reporting. The results of a root cause analysis and corrective preventative actions can be submitted as a follow-up report at a later date.

    It is the responsibility of the Designated Individual (DI) to notify the HTA of any suspected SAE or SAR. In the DI’s absence this responsibility can be delegated to other designated members of staff; however, the DI retains overall responsibility for ensuring that such notifications and reports are received by the HTA.  

    If you are a third party providing services to a licensed establishment, or if you purchase material from a licensed establishment, then you should report SAEs and SARs directly to the DI of the establishment you are working with. You should advise the DI that they need to report to the HTA on your behalf. 

    Please note, systems for reporting SAEs and SARs are not intended to replace existing local reporting requirements.
     

    The HTA is designated the  UK competent authority for the purposes of the European Tissues and Cell Directives so far as they relate to tissues and cells. As such, it has a statutory obligation to ensure that systems are in place to report, investigate, and share information about SAEs and SARs. This includes a duty to communicate information about any SAEs or SARs to other relevant persons or bodies such as: persons and establishments carrying out human application activities, other competent authorities and to the European Commission. This allows appropriate action to be taken if tissues or cells need to be withdrawn or control measures are required. In compliance with this requirement, the HTA issues regulatory alerts if it becomes aware of circumstances affecting a number of tissue establishments.

    The authority is also required to keep a register of SAEs and SARs and to make this information available to the public in a manner that it considers appropriate. The HTA has included information about SAEs and SARs in the summary of compliance reports for the Human application sector and is currently considering how best to share further learning from the submitted reports with the sector.

    A serious adverse event is defined as ‘any untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of tissue or cells intended for human application and which, in relation to a donor of tissue or cells intended for human application or a recipient of tissue or cells: (a) might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions, or (b) might result in, or prolong, hospitalisation or morbidity.

    A serious adverse reaction is defined as ‘an unintended response, including a communicable disease, in a donor of tissue or cells intended for human application or a recipient of tissue or cells, which may be associated with the procurement or human application of tissue or cells and which is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.

    SAEs and / or SARs can be reported to the HTA via the HTA Portal.

    You will require a username and password to log into the Portal. If you do not have a username and password, please use the form on the Portal to register. Once your registration has been approved you will receive an email notification to let you know that your account is active.

    If you have forgotten your password, you can request a password reminder.

    If you have forgotten your login details, you can request a password reminder.

    If you are experiencing any other problems with the HTA Portal, please contact a member of the Serious Adverse Event or Reaction (SAEARs) team on 020 7269 1900 or email saears@hta.gov.uk.

    Can anyone at the establishment report to the HTA?

    It is ultimately the responsibility of the Designated Individual (DI) to notify the HTA of any suspected serious adverse event or reaction. In the DI’s absence, this responsibility can be delegated to other designated members of staff through the HTA Portal (this process should be supported by a clearly documented procedure outlining such delegated responsibilities). 

    The initial notification to the HTA should be made within 24 hours of the discovery or determination of the SAE or SAR by the licensed establishment. Third parties and end users should be instructed to report to the licensed establishment within 24 hours of their discovery of SAEs or SARs. Tissue establishments should be able to respond to SAEs and SARs within this time frame inside their normal operational hours.

    The establishment should not wait to conduct an investigation prior to reporting to the HTA. There is a separate form on the notification system which allows further follow-up information to be provided once an investigation has been completed.

    If a serious adverse event or reaction has implications for other tissue establishments - for example,  because of a shared donor - the tissue establishment should also notify those other tissue establishments as appropriate without delay.

    Please note, the systems for reporting SAEs and SARs to the HTA are not intended to replace existing local reporting requirements.

    A serious adverse event (SAE) can occur at any stage from donation to transplantation. A suspected SAE should be reported to the HTA when one or more of the following applies:

    • inappropriate tissues / cells have been distributed for clinical use, even if not used;
    • the event could have implications for other patients or donors because of shared practices, services, supplies or donors;
    • the event resulted in loss of any irreplaceable autologous tissues or cells or any highly matched (i.e. recipient specific) allogeneic tissues or cells;
    • the event resulted in the loss of a significant quantity of unmatched allogeneic tissues or cells.

    Examples of reportable SAEs are given at the bottom of this FAQ.

    If you are unsure whether an adverse event constitutes an SAE and requires reporting to the HTA, please contact the HTA for further guidance.

    Events which are commonly referred to as ‘near misses' should be reported as SAEs if any of the above criteria are met.

    Any serious adverse reaction in a living donor which may influence the quality and / or safety of tissues and cells should be reported to the HTA.

    Any serious adverse reaction in a recipient observed during and / or after clinical application which may be linked to the quality and / or safety of tissues and cells should be reported to the HTA.

    Suspected serious transmitted infections (e.g. bacterial, fungal, viral, prion, parasitic) should always be reported to the HTA.

    Examples of reportable serious adverse reactions are given at the bottom of this FAQ.

    If you are unsure whether an adverse reaction constitutes an SAR and requires reporting to the HTA, please contact the HTA for further guidance.

    When the HTA receives notification of an SAE or SAR, a member of the serious adverse events and reactions (SAEARs) team will review the information provided in the initial report and contact you if further information is required. Establishments are expected to submit a follow-up report once internal investigations have been completed. A member of the SAEARs team may advise if any further actions are required. During the HTA’s review process, we may offer advice and guidance to the reporting establishment, and / or participate in the development of corrective and preventative actions. 

    The HTA may use the information in SAEARs reports to adjust an establishment's risk rating which could prompt a site visit inspection. If required, the HTA may issue a regulatory alert to inform other establishments in the human application sector, and / or competent authorities in other EU member states where there may be implications for establishments outside the UK.

    Referral letters written by the medical practitioner with responsibility for the donor (or the appropriate nurse specialist) must be sent to the Accredited Assessor in advance of the statutory interview.

    This letter must include confirmation that the donor lacks capacity/competence to consent and is therefore unable to make a decision about donation themselves. This means that a competence assessment must have been undertaken unless the donor clearly lacks competence, for example if they are a baby or very young child.

    A template referral letter can be found here.

    The HTA retains a register of the notifications it receives from establishments. The HTA has a statutory obligation to report annually to the European Commission on the notifications it has received. Additionally, the HTA is participating in a pilot on surveillance and vigilance as part of the EUSTITE project, more information about this project can be found at www.eustite.org

    The HTA is currently developing a communications plan to determine the best ways of sharing wider learning from SAEs or SARs, to the human application sector. Once finalised, details will be available on this website.

    Third parties and end users should report suspected SAEs or SARs to the licensed tissue establishment within 24 hours of the discovery of the event or reaction. Tissue establishments should be able to respond to SAEs and SARs within this time frame inside normal operational hours.  

    If the suspected SAE or SAR is linked to donor selection, procurement or donor testing then you should notify the HTA.

    Yes, if the suspected SAE or SAR occurred in the UK, you should report to the HTA. You should also report to any organisations in other countries to which you have supplied implicated tissues / cells.

    A follow-up report should be submitted using the online system within 24 hours following completion of the internal investigation.

    For SAEs, the follow-up report should include details of the investigation, including a root cause analysis and details of any corrective or preventative actions identified.

    For SARs, the follow-up report should include details of the investigation, including confirmation of whether it was an SAR, the clinical outcome, the outcome of the investigation and any corrective and preventative actions identified.

    Positive microbial test result on stem cells detected at a tissue establishment post transplantation. No adverse reaction detected in the recipient.

    • reportable as a suspected SAE as inappropriate tissues may have been distributed for use.

    A dry shipper containing an autologous bone marrow donation being transported for immediate transplant is stolen from the courier.

    • reportable as a suspected SAE as there has been a loss of irreplaceable autologous cells.

    Liquid nitrogen (LN2) container runs out of LN2; 120 heart valves thaw and are discarded.

    • reportable as a suspected SAE as there has been a loss of a significant quantity of allogeneic tissue which could have an impact on supply.

    Cryopreserved skin past its expiry date is distributed and used on a burns patient. Discovered after the procedure.

    • reportable as a suspected SAE as inappropriate tissue may have been distributed for use.

    Significant loss (80%) of stem cells in an autologous bone marrow graft following freezing / thawing (viability and CD34+ measured). Graft infused as there is no other option.

    • reportable as a suspected SAE as there has been a loss of irreplaceable autologous cells. This case could become a SAR depending on the outcome in the donor / recipient.
       

    Skin graft recipient tests positive for hepatitis B six months after the skin grafting procedure. 

    • reportable as a suspected SAR (communicable disease which may be linked to the tissue product).

    Stem cell recipient exhibits fever post infusion, haemoculture matches bacterium discovered in the bone marrow product.

    • reportable as a suspected SAR (communicable disease which may be linked to the quality and safety of the tissue).

    According to the stillbirth and neonatal death charity Sands, around 15 babies a day die before, during, or soon after birth (ref - Baby death: current picture (2016)).

    More babies die during this period of their early lives than at any other stage of childhood. The number of stillbirths, in particular, has changed little in more than a decade.

    A post mortem examination is the single most useful investigation in providing information about cause of death. However, perinatal post mortem rates in the UK are low.

    The low post mortem rate means that many parents are left with unanswered questions about why their baby died, and about what might be done in subsequent pregnancies to avoid further deaths. It also means that there is little information on which to base measures and policies that might reduce the UK’s perinatal mortality rate.

    Research shows that a significant number of health professionals underestimate the value of a perinatal post mortem and so may not discuss a post mortem with parents. Many professionals may find this discussion difficult and fear that it will add to the distress of the bereaved. Additionally, research indicates that the quality of the consent process is important in increasing post mortem rates.

    On 26 March 2019 the government launched a consultation on proposals to give coroners the power to investigate all full-term stilbirths, to help provide parents with vital information on what went wrong, and why, whilst ensuring any mistakes are identified to prevent future deaths.

    You can find more information on this consultation here - New powers to investigate stillbirths.

     

    The forms are designed to be used when seeking post mortem consent for babies from about 12 weeks’ gestation until about two years old. However, the decision about the age range should be taken by the hospital or trust.

    In consultations, Sands found that the length, detail and complexity of many current forms add to parents’ distress and makes discussion harder for consent takers. One of Sands’ aims is to provide a shorter, clearer form that guides consent takers through the discussion.

    Parents should be offered written back-up information, if possible before the discussion takes place. All consent takers should be able to answer the questions that parents are likely to ask.

    In Sands consultations, parents said they did not like the phrase 'baby/child'. It made the form seem bureaucratic, insensitive and uncaring, and added to their distress.

    Sands found that parents found it very helpful to know that the difficult decisions they were being asked to make were not absolutely final. This reduced their anxiety and helped them focus better on their discussion.

    Our code of practice requires consent takers to explain that parents can change their minds about any aspect of the post mortem at any time before it begins.

    A signature on a consent form when a non-emergency procedure or treatment is refused is not necessary. If a post mortem is refused, this should be recorded in the medical notes. The medical record can be used if this information is needed for audit.

    The HTA has ruled that additional specific consent is not required to keep an organ outside the body for examination to establish the cause of death if the organ will be returned to the baby’s body before the body is repaired and released from the mortuary. This is because it is part of the post mortem examination for which consent has already been given. Parents only need to be asked specifically for consent to keep an organ if it is recommended that the organ is kept for further examination or a specialist opinion beyond the time when the body will be released.

    There are a few hospitals in the UK where organs are more likely to be kept after the baby’s body is released, so Sands has developed an 'Optional' section on keeping organs which can be inserted in the standard form in those hospitals if it is necessary. See Adopting the Sands Post mortem consent form in your hospital, trust or health board for more about this.

    Yes. As storage is the primary licensable activity for acellular distributors, the HTA has taken the decision that qualifications in quality management and / or business management, alongside a minimum of two years practical experience, would be considered appropriate.

    However, DIs that do not possess medical or biological qualifications must follow the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatmentas implemented by HTA Directions 002/2018 and ensure that they have access to a nominated registered medical practitioner and / or a scientific advisor, as the HTA considers appropriate.

    All DIs must have access to a nominated registered medical practitioner and / or a scientific advisor, as the HTA considers appropriate. This person should be suitably qualified and possess sufficient knowledge of the licensable activities so that they can advise the DI about related matters (for example, regarding a serious adverse event).

    Contact arrangements should be formalised and include alternative arrangements for the provision of advice in the event that the original scientific adviser or registered medical practitioner is unavailable.

    The HTA will not usually ask to see documents evidencing these relationships during the desk-based inspection; however this information may be requested during a site-visit inspection. We would expect the DI to be able to explain to our inspectors why their advisor is appropriate and provide details of their contact arrangements.

    Yes. In general, all standards are applicable to an establishment carrying out licensable activities.

    Even if procurement, testing and processing of material does not take place on an establishment’s premises, the DI is still responsible for ensuring that all of the relevant HTA standards are met for any acellular products to pass through their premises. Therefore, we require the DI to assess the compliance of their premises and the premises of any procuring or processing organisations when providing a score for each of the HTA standards.

    Establishments importing material from non-European Economic Area (EEA) states should refer to the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA Directions 002/2018, which detail the requirements.

    Designated Individuals might also find it useful to refer to our FAQs on third party agreements.

    The majority of HTA standards on the compliance report application should be answered as referring to both the licensed premises and the premises of the procuring organisation.

    Distributors must ensure that the following are in place with end users:

    • documented agreements to ensure that they record and store the data required by the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by Directions 002/2018, including data retention periods.
    • documented agreements specifying that the end users will report all serious adverse events and reactions to the licensed establishment, including reporting timelines.
    • documented procedures for end users to report serious adverse events and reactions, including procedures for reporting outside of normal working hours. Agreements should include the need for end users to have documented reporting procedures in place and the establishment should provide end users with guidance on what incidents should be reported.

     

    For the tissue and cells for patient treatment (human application) sector, there is a requirement for establishments to undergo a site-visit inspection at least every two years. Inspections for this sector are scheduled taking this and each establishment’s individual risk level into account, therefore some establishments may be inspected more often than others.

     

    All site-visit inspections involve:

    • visual inspection of areas where licensable activities take place (e.g. storage);
    • document review;
    • audit trail
    • interviews wit;h key staff (e.g. DIs, Persons Designated etc).

    As procurement, testing and processing are not carried out by acellular distributors, the document review will focus on understanding how DIs have satisfied themselves that these activities are being carried out under suitable agreements. Our inspectors will be looking to assure themselves from the available documentation that all licensable activities are fully compliant with HTA standards.

    The documents that the inspectors would expect to see include:

    • policies and standard operating procedures relating to the establishments licensable activities (e.g. covering the reporting of serious adverse events, disposal policy);
    • risk assessments; including consideration of risks to staff, visitors and the products themselves;
    • all contracts, written agreements, service level agreements and third party agreements relating to licensable activities. The written agreements with procuring companies and end users will be of particular interest;
    • other relevant documents that the HTA’s standards require the establishment to have in place (e.g. recall procedure).

     

    The Human Tissue Authority (HTA) regulates the procurement of cord blood in the UK under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations). The Q&S Regulations were established to ensure that the quality and safety of human tissues and cells (including cord blood) which may be used for treatment is maintained from the time of collection through to end use.

    In the UK, procurement of human tissues and cells which may be used for treatment (including cord blood) must occur on HTA-licensed premises or under a third party agreement (TPA). In the latter case:

    The two types of TPA that may be suitable for the procurement of cord blood are:

    • a TPA between an HTA-licensed cord blood establishment and the hospital whose staff will carry out the procurement; or
    • a TPA between the HTA-licensed cord blood establishment and an individual procurer, e.g. an independent phlebotomist, who will carry out the procurement.

    The HTA has produced a guidance document for establishments licensed by the HTA to undertake activities related to the procurement, testing, processing, storage, distribution, import and export of umbilical cord blood cells . This document will raise awareness of how the legislation relates to these establishments and provide advice on areas which are specific to cord blood and related tissues.

    Not necessarily. In addition to collection being undertaken on licensed premises, the procurement of cord blood can also be undertaken by:

    • a healthcare professional who has (a) completed training to the approval of the Designated Individual named on a cord blood establishment’s HTA licence, and (b) has entered into an individual third party agreement with an HTA licensed cord blood establishment; or
    • by a healthcare professional who has (a) completed training to the approval of the Designated Individual named on a cord blood establishment’s HTA licence, and (b) is working for a hospital who holds a third party agreement with an HTA-licensed establishment.

    If the premises where procurement will take place are not licensed by the HTA, the procurer must ensure an appropriate third party agreement is in place with a HTA-licensed cord blood establishment prior to procuring the cord blood.

    The patient’s chosen cord blood establishment is responsible for issuing third party agreements and setting out the terms under which the cord blood can be procured. A compliant Third Party Agreement will include provisions relating to consent, training, transport and packaging of the cord blood, record keeping and disposal.

    Please note that when cord blood is collected on premises under a Third Party Agreement, the premises where the cord blood will be collected (e.g. delivery suite or private home) become 'Relevant Third Party Premises' (RTPPs). There is a legal requirement that RTPPs are suitable for the activity to be undertaken – in this case the procurement of cord blood. An HTA-licensed establishment issuing a Third Party Agreement has a legal duty to satisfy themselves that RTPPs are suitable by requiring the procurer to assess the RTPP prior to collection of cord blood. In addition, the HTA has the power to inspect any RTPPs.

    If a hospital does decide to allow an external phlebotomist on site to procure cord blood, it should assure itself that the phlebotomist is working under a third party agreement with an HTA-licensed establishment.

    We recommend that hospitals have systems for confirming that a Third Party Agreement is in place between an HTA-licensed establishment and the procurer before allowing cord blood to be collected. This might be achieved by updating the hospital’s policy to state that private cord blood establishments must provide the hospital with written notification of who the third party is and confirm that a Third Party Agreement in line with the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA Directions 002/2018, is in place.

    Not usually. This would only be possible if the patient’s partner was a registered healthcare professional trained in the collection of cord blood and acting under a third party agreement with an HTA-licensed establishment.

    The requirement for an HTA licence is not dependent on the amount of activity, but on whether an activity is ever carried out. If your establishment is involved, or wants to become involved, in the collection of cord blood intended for future treatment then you will require an HTA licence.

    Alternatively, a third party agreement could be put in place for the lawful procurement of the cord blood (please see FAQ 'A patient has approached me to collect cord blood during the delivery'). In this situation the hospital would not require a licence.

    Training ensures that the person collecting the cord blood is competent to undertake cord blood collection. Training will ensure that the risk of physical harm to the mother and child during the cord blood collection is minimised; and, that processes are followed to reduce the possibility of the cord blood being contaminated during collection.

    The HTA does not licence the end use of cord blood in medical treatment.

    Establishments distributing cord blood for end use must comply with the requirements of the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA Directions 002/2018, which include provisions for traceability and reporting of serious adverse events and reactions.

    The Royal College of Obstetricians and Gynaecologists (RCOG) have produced guidelines on cord blood banking. The HTA endorses these guidelines. These guidelines state that: -

    'Cord blood must be collected safely. It is important that:

    • A trained technician who is not involved in your care or your baby's care collects the cord blood. It is important that neither your obstetrician nor your midwife is distracted from looking after you and your baby during and immediately after childbirth.
    • There should be no alteration in your ‘usual management' of labour, such as the delivery of the placenta or clamping of the cord. Some evidence indicates that immediate cord clamping may be harmful to babies. However, delaying cord clamping can prevent a successful cord blood collection.
    • Cord blood should be collected after the placenta has been delivered in a clean environment using methods and facilities, which meet the required regulations including the EU Tissue and Cells Directive.'

    Please refer to the RCOG’s website for further information.

    The definition of procurement for the purposes of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) (as amended) is quite wide. Regulation 5(2) of the Q&S Regulations makes it clear that (unless otherwise provided for in the Regulations), words and expressions used will have the same meaning as in Article 3 of EU Tissues and Cells Directive 2004/23/EC. Article 3 states that "'procurement' means a process by which tissue or cells are made available".

    The provision of cord blood collection kits to clients therefore falls within the definition of procurement, since it is a part of the process by which tissues or cells are made available. Procurement is a licensable activity under the Q&S Regulations. The advertisement and distribution of cord blood collection kits is also included in the definition of ‘procurement'.

    Under the Q&S Regulations, storage is defined as "maintaining tissues or cells, whether by preservation or in any other way, for more than 48 hours". Since cord blood will normally be stored in the cord blood establishment for more than 48 hours a HTA licence is required.

    It is not possible to use a third party agreement to delegate the licensable activity of storage to a third party. Regulation 7(1) of the Regulations makes it unlawful to store cord blood intended for human application other than under the authority of a HTA licence.

    The HTA has produced a guidance document for establishments which the HTA licences to undertake activities related to the procurement, testing, processing, storage, distribution, import and export of umbilical cord blood cells (you can download a copy of this document on the left side of this page). This document will raise awareness of how the legislation relates to these establishments and provide advice on areas which are specific to cord blood and related tissues.

    Traceability refers to the completeness of auditable information about every step in the pathway for the use of relevant material, from consent through to disposal or use of the tissue to extinction. Documented records are used by licensed and unlicensed establishments to evidence traceability and ensure a robust audit trail. The actual types of records that enable traceability may vary from establishment to establishment, depending on what kinds of records are created during the licensed activity.

    Records may be in various formats, including paper, electronic, or stored on recordable media such as CD-ROM or DVD. It is up to each establishment to determine the best storage method for their records.

    With the exception of the human application sector, the HTA is not prescriptive about the length of time for which traceability records should be retained. In other sectors, additional bodies may have specific requirements for the retention of records. Additional guidance for each of the sectors is provided below.

    Establishments in the human application sector should refer to the HTA’s Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment for specific requirements for record retention.

    HTA-licensed NHS Trusts should adhere to the two-part document Records Management: NHS Code of Practice, available on the Department of Health’s website, as this sets out the requirements for retention of all NHS records. The current position is that all NHS records created as a result of work taking place in accordance with the Human Tissue Act 2004 are to be retained for 30 years.

    Staff at HTA-licensed establishments should refer to the HTA’s code of practice on Post-mortem examination, paying particular attention to the Records Management section of the code.

    The HTA endorses the most up to date guidance from the Royal College of Pathologists, The retention and storage of pathological records and specimens. This document is available on the Royal College of Pathologists’ website.

    Additionally, where HTA-licensed post mortem establishments are part of an NHS Trust, consideration should be given to the above general advice for NHS Trusts.

    Records that enable traceability must be maintained at least until the tissue has been disposed of, used to extinction or otherwise brought outside of the regulatory framework, or will never be used again in research. Licensed research establishments should refer to the Governance and Quality Systems section of the HTA’s code of practice on Research. Staff at licensed establishments should also adhere to any relevant organisational/committee policies and procedures for records management e.g. NHS Trust requirements (see above), Medical Research Council requirements etc.

    Records that enable traceability must be maintained at least until the tissue has been disposed of. Staff at HTA-licensed establishments should refer to the Documentation and Record Keeping section of the HTA’s code of practice on Anatomical examination.

    Records that enable traceability must be maintained until the tissue has been disposed or reaches an age when it falls outside the Human Tissue Act 2004 (i.e. more than 100 years old). For temporary exhibitions where relevant material will be exported rather than disposed of, it is acceptable that traceability records are exported with the exhibition once the HTA licences have been revoked.

    Staff at HTA-licensed establishments in the public display sector should refer to the Governance and Quality Systems section of the HTA’s code of practice on Public display.

    Additionally, museums and other public display establishments should refer to the Guidance for the Care of Human Remains in Museums, published in the Department for Culture, Media and Sport’s website.

    If there is no overarching records retention policy in place at the establishment, the Designated Individual should ensure that relevant policies and procedures are put in place. These should be in line with the establishment’s own internal requirements. Retention schedules are to be made available to the HTA on inspection or as otherwise requested in writing or by Directions.

    1. The DI should consider undertaking a documented risk assessment of retaining/disposing of each type of record to enable a robust and appropriate records management policy to be established.
    2. The DI may wish to consider good practice examples from other similar organisations.
    3. The DI should ensure that the records retention policy considers the storage of documents beyond the minimum requirements e.g. if the establishment were to shut down.

     

    Staff at Establishments that store records containing personal data for tissue which has been taken from the living need to consider that ‘Personal data processed for any purpose or purposes shall not be kept for longer than is necessary for that purpose or those purposes’.

    The Data Protection Act 1998 does not apply to personal records relating to the deceased; these are covered by common law and confidentiality.

    Any establishment that intends to revoke their licence should retain traceability records in accordance with their documented record retention requirements in place during the period of licensing. Particular things to consider are:
    a) If any relevant material is being transferred to alternative licensed premises, the records to enable traceability should be transferred to those premises also.
    b) If the licence to be revoked is associated with other licensed premises e.g. where a satellite licence is being revoked but the hub is remaining licensed, the records should be transferred to the associated licensed premises (in this case, the hub).
    c) If there is no alternative site that the records could be transferred to (e.g. a private organisation which has gone out of business), it is good practice to retain those records and provide the HTA with contact details.

    The disposal of traceability records should be carried out in such a way that the confidentiality of the data is maintained. For more information please refer to the Information Commissioner’s Office.

    By studying human tissue, scientists improve their understanding of how diseases start and progress, and what keeps us healthy. They may find different ways of diagnosing disease, or develop new treatments. Types of research involving human tissue include developing screening tests for different types of cancer, testing new treatments for conditions such as heart disease and diabetes, looking at how the immune system works to help understand how it combats diseases and researching how stem cells could be used to treat conditions like Parkinson's disease and multiple sclerosis.

    If tissue or cells are removed during the course of treatment or a diagnosis, there may be some left over that can be used for research. Tissue from living patients - for example biopsy or blood samples - can ordinarily be used for research only with the person's consent. The HTA ensures that it is removed and stored in an appropriate and well managed way.

    Consent is not required for research on tissue from living patients if the samples are anonymised (or coded to make sure patient or participant information is not identifiable) and the project has recognised ethics committee approval; or if the tissue samples were obtained before 1 September 2006 (when the Human Tissue Act came into force). Information for professionals on consent and HTA licensing requirements is available in our code of practice on research.

    If people do not want their tissue to be used for any medical research, or they want it to be used only for specific types of research, it is important that they make this clear to the healthcare professional who seeks their consent, and that their wishes are documented.

    Consent is always required for research on human tissue from deceased patients unless the tissue samples were obtained before 1 September 2006.

    A person may consent for their tissue to be used for research after their death. Consent is always required for research on human tissue from deceased patients unless the tissue samples were obtained before 1 September 2006. If there is no record of the deceased person's wishes, consent for research can be obtained from someone nominated by that person to act on his or her behalf; or, if no one has been nominated, from a person in a ‘qualifying relationship' - this can be a partner, relative or friend. Read about consent and licensing requirements for tissue taken during a coroner's post mortem which may be used for research.

    If you are suffering from a disease or condition, you may be asked by the person treating you if you would like to donate tissue after your death. If you would like to donate and have not been approached, you could ask your treating physician.

    If you want your tissue to be used for any medical research, or you may want it to be used only for specific types of research, it is important that you make these wishes clear to the healthcare professional who seeks your consent, and that they are stated in writing on a consent form. However, you should be aware that some tissue establishments may not be able to use your tissue at all if you impose very specific requirements for its use. If you are happy for your tissue to be used in any research relating to human health, you should consider giving what is termed ‘generic consent'.

    A research tissue bank is a collection of tissue that may be used in many different research projects. Tissue that is being stored is often of a certain type; for example, tissue that is collected from people with a particular disease such as Alzheimer's or Parkinson's disease or from a part of the body such as the liver or lungs.

    Banks also require tissue from people without a disease to act as a comparison for tissue from someone with a disease. For example, someone who has multiple sclerosis and someone who does not can both donate to a multiple sclerosis tissue bank. If people would like to donate tissue to a research tissue bank, they should contact the research tissue bank directly. The research tissue bank will be able to advise whether it is possible to donate tissue and give more information about what donation entails. Most research tissue banks or disease charities that need donations have websites with contact information for potential donors. Read about the multiple sclerosis (MS) tissue bank at Imperial College London.

    When people refer to donating their whole body to medical science, they usually mean donating their bodies to a medical school after their death (read body donation FAQs). Their bodies will be used to teach healthcare professionals and students about the human body. Whole body donation is different to donating tissue for research only. Click here to find out more about body donation.

    Being on the NHS Organ Donor Register does not mean that a person has consented to tissue being used for research after death. Organ donation and tissue donation for research are not mutually exclusive and, depending on the circumstances, someone may be able to do both.

    An HTA licence for research is granted to an organisation if it shows it complies with standards set down by the HTA. These requirements include: consent for the tissue to be used in research is taken by appropriately trained personnel and is recorded; confidentiality is maintained; the environment tissue is stored in is suitable; there are security measures to lock away the tissue; and the tissue is traceable.

    Tissue banks may charge for providing donated tissue samples to researchers, including those working for private companies, so they can cover their costs. Where charging or cost-recovery is in place, the HTA expects research tissue banks to provide potential donors with sufficient information to ensure they understand that their tissue may be provided to researchers for a fee. The HTA also recommends that research tissue banks are transparent, by providing easily accessible information about how and why they charge, and to whom they will supply tissue samples. Potential donors can expect to be informed if their samples could be used for research involving the commercial sector, consistent with our code of practice on consent.

    These are separate scheduled purposes under the Human Tissue Act 2004 (HT Act).

    Anatomical examination is defined in the HT Act as 'macroscopic examination by dissection for anatomical purposes', for which anatomical purposes are defined as: 'purposes of teaching or studying, or researching into, the gross structure of the human body'.

    Education or training relating to human health describes the education or training of healthcare professionals, such as those learning surgical techniques.

    The HT Act defines an anatomical specimen as:

    1. the body of a deceased person to be used for the purpose of anatomical examination, or
    2. the body of a deceased person in the course of being used for the purpose of anatomical examination (including separated parts of such a body)

    'Former anatomical specimens' are not defined in the HT Act. The HTA defines a former anatomical specimen as: 'An organ or body part donated for anatomical examination which is retained once the examination of the rest of the body has been completed'.

    No. Although the term may be used by some staff working at anatomy establishments, the concept of 'one third of a body' has no legal status under the HT Act and is not used by the HTA. Independent of the HTA, professional guidelines have been drawn up by the Professional Guidelines and Practices (Anatomy) Committee and are available on the websites of three professional bodies which comprise the committee, namely: the Anatomical Society of Great Britain and Ireland (ASGBI), the British Association of Clinical Anatomists (BACA) and the Institute of Anatomical Sciences.

    The HTA's codes of practice and other guidance should, however, be used as the definitive source of information for issues within our remit. If you are in any doubt, please contact the HTA.

    Many people regard cremation as a more dignified or respectful method of incineration. In England, Wales and Northern Ireland, two different sets of regulations govern the process of cremation: the Cremation (England and Wales) Regulations 2008 and the Cremation (Belfast) Regulations (Northern Ireland) 1961. Both sets of cremation regulations are outside of the remit of the HTA but fall within that of the Ministry of Justice.

    The HT Act does not reference a method of disposal according to the type or size of the specimen or relevant material.
    It is good practice for staff at HTA licensed establishments to agree the acceptance criteria for relevant material with their local incineration facility as part of any disposal agreements. It may be that staff at HTA licensed establishments are required to reduce the size of relevant material prior to it being sent for disposal by incineration.

    As the Designated Individual (DI) at a suitably licensed establishment, firstly you should ensure the overseas supplier is reputable and that you are happy that the terms of the arrangement would be consistent with the HTA's code of practice on Anatomical examination.

    We expect DIs to scrutinise any agreements with suppliers of imported material to ensure that they are acting lawfully and in accordance with any consent given by the donor. If an agreement stipulates cremation as the only method of disposal, and only incineration will be possible, we advise that the DI should first clarify with the supplier whether the meaning of the word cremation in the agreement is consistent with the definition of cremation in the UK. If so, the DI should not accept the specimens or body part as the wishes of the deceased could not be met.

    When someone dies it can be a distressing and confusing time for family members. In some circumstances a post-mortem examination may be required or requested. This is an examination of a body after death and during this examination, organs and tissue samples may need to be removed for investigation. After the post-mortem examination decisions will need to be made about what should happen to the removed organs and tissue samples.

    This information has been provided to support those who are bereaved and are affected by a post-mortem examination. It may also be useful for professionals who work with the bereaved or seek consent for post-mortem examinations.

    If a post-mortem examination is required or requested then a discussion should take place between you and a professional from the hospital or the coroner’s service. This discussion should cover what you can expect; what will happen; and what your rights are. It should also provide you with information to help you make decisions about what happens to organs and tissue samples that may need to be removed for investigation.

    During a difficult time you may wish to take this information away with you to read in your own time and to refer back to during or after your discussions.

    This information takes the form of questions and answers and can be used in full or in part, as required. It applies in England and Wales. It does not apply in Northern Ireland or in Scotland. See Further information and support section for more details.

    • That in some cases you will be asked to make some decisions. These may be to discuss any need for consent, or to decide what happens to organs and tissue samples that may need to be removed for investigation. Your wishes will be respected.
    • That you will have the opportunity to have a discussion with a professional trained in seeking consent. This should include a full explanation of what the organs and tissue samples may be used for, and any benefits to the family of keeping tissue. This is so that you have all the information you need to help you reach a decision.
    • That any particular needs that you have, which could be cultural, religious or practical, will be taken into account as far as possible.
    • That where consent is not given for storage of organs or tissue samples they are disposed of in a timely and respectful manner.

    A post-mortem examination is the examination of a body after death and can also be called an autopsy. Post-mortem examinations are carried out for two main reasons:

    1. At the request of a Coroner, because the cause of a death is unknown, or when a death happens unexpectedly or suddenly.
    2. At the request of a hospital, to provide information about an illness or cause of death, or to advance medical research.

    These medical examinations of the body can be extremely useful in determining how, why and when someone has died, or providing information about the effect of treatment given, or the events leading up to death. They can also be useful to better understand how a disease has spread; or whether the person who died had a genetically inherited disease. Finding out more about illnesses may help doctors treat patients in the future.

    Post-mortem examinations are carried out by Pathologists, trained doctors who work to standards set by the Royal College of Pathologists and the Human Tissue Authority (HTA).

    A Coroner’s post-mortem examination is carried out under the authority of a Coroner to find out how someone died, and whether an inquest is necessary. You will not be asked to give consent for a Coroner’s post-mortem examination. This is because the Coroner is required by law to investigate deaths which are violent, unnatural or sudden with unknown cause, or those which occurred in prison.

    In some circumstances a Coroner may open an inquest into the death of an individual after a post-mortem examination. If the Pathologist certifies that they have a bearing on the cause of death, the Coroner may require that any retained organs and tissue blocks and slides are kept until the Coroner’s function is complete. Similarly if there is a possibility of criminal involvement in the death, tissue may be needed by the police as evidence, separate to the Coroner’s requirements.

    In both cases, the tissue samples, blocks and slides or organs may need to be kept for several months, in some cases, years. As a result this may affect what you want to happen to them.

    If there is a need for an inquest, this and the implications will be discussed with you by the Coroner’s office.

    A hospital post-mortem examination is sometimes requested by a hospital, to provide information about an illness or cause of death, or to advance medical research. A hospital post-mortem examination can only take place with consent. Sometimes the person may have given consent before they died. Where this is not the case a person close to them can give consent. In these circumstances, the Medical Certificate of the Cause of Death will usually have been issued before the post-mortem examination, but the doctors who looked after the person before they died may request the examination to obtain more information.

    Hospital post-mortem examinations can be limited to certain areas of the body, such as the head, chest or abdomen, and this will be discussed with you when your consent is sought. Only those organs or tissue you agree to can be removed and will be examined.

    The HTA recommends that you should be given 24 hours to consider your decision about the post-mortem examination, and that you will be given details of someone to contact if you change your mind.

    The post-mortem examination will be carried out as soon as possible and usually within two to three working days after the death. It may be possible to arrange it within 24 hours if necessary. The examination will be carried out in a post-mortem examination room, rather like an operating theatre, which is licensed and inspected by the HTA.

    During a standard post-mortem examination the body is opened and organs are removed for examination. Most of the time, a diagnosis can be made by looking at the organs, and they will then be returned to the body.

    Organs and tissue are made up of cells. Tissue is a collection of cells with a specific role. Tissues include blood, blood vessels and muscle. Small samples or biopsies taken from organs are often classed as tissue. Organs are made up of more than one type of tissue and have a specific role in the body. They also have their own structure and blood supply. The body has many organs including the brain, heart, lungs, kidneys and liver.

    In around 20% of adult post-mortem examinations and in most paediatric post-mortem examinations, the cause of death is not immediately obvious. A diagnosis can only be made by retaining small tissue samples of relevant organs for more detailed examination. The Pathologist may need to retain a whole organ for a full assessment to allow an accurate diagnosis of the cause of death to be made. For example, this may be the brain in cases where there has been a head injury or the possibility of a complex disease like Alzheimer's disease or multiple sclerosis, or the heart to confirm disorders like congenital heart conditions. When this happens the organ or tissue is normally sent to a specialist unit.

    These full assessments often take weeks or even a few months to complete, depending on the extent of the investigations required. Once they are complete, the Pathologist will produce a report for the Coroner or the medical staff responsible for the care of the person before they died.

    Tissue samples

    Small tissue samples which are needed for further examination are usually set into blocks made from paraffin wax. The wax blocks are sliced into very thin layers, which are about ten times thinner than a hair. These slices are placed onto glass slides and stained with a special dye to allow cells to be studied under a microscope.

    Organs

    If whole organs, part of an organ, or tissue are needed for more detailed examination, they will normally be treated with a chemical that preserves them. Samples of the organ or tissue may then be processed into blocks and slides as described above.

    When the post-mortem examination is complete, you will be told whether tissue samples and organs have been retained.

    If tissue samples and organs have been retained then you should expect to be given a choice about what happens to them when they are no longer needed by the Coroner or the hospital. Your consent will be needed for any tissue samples or organs to be kept for future use such as research or education and training of medical staff. An example of a consent form.

    The most important wishes to consider are those of the person who has died. If it is known that the person who has died gave consent or specifically did not want to give consent to the retention of tissue samples or organs, then those wishes must be respected.

    If their wishes are not known, then a person nominated by them when they were alive, or someone in a relationship with them or closely related, must give consent. The Human Tissue Act defines a list of ‘qualifying’ relationships, which are ranked. That means that the person nearest the top of the list should be approached and a decision of that person cannot be overturned by someone below them in the list. The spouse or partner is highest on the list, and a long term friend is at the bottom. If there is more than one person at the same level, for instance there may be two or more siblings, consent is only required from one of them.

    As defined in the Coroners Rules, any ‘properly interested person’ may give a decision to the Coroner about how the samples must be treated when their investigation has ended. Whilst the relationships between the person who has died and the properly interested person are similar to ‘qualifying relationships’, they are not ranked in the same way. If a decision to retain tissue samples or organs is made by a properly interested person, a Pathologist or another healthcare professional may need to contact the family to make sure the requirements of the Human Tissue Act are met for storage and / or use of the material for medical research or other purposes.

    With the interests of the public and those we regulate at the centre of our work, we aim to maintain confidence by ensuring that human tissue is used safely and ethically, and with proper consent. In England, Wales and Northern Ireland, all hospital and local authority mortuaries where post-mortem examinations take place are licensed and inspected by the HTA and must show they meet our standards. Valid consent is at the centre of the Human Tissue Act – the law that established the HTA.

    If our standards are not met, we take action which ranges from providing advice and guidance, restricting activity in a mortuary or, in extreme cases, asking an establishment to stop working until our standards are met. The HTA does not regulate Coroners and is not responsible for the professional practice of Pathologists.

    More information about our work, including a code of practice on Post-mortem examination, is available at: www.hta.gov.uk. If you have any questions please contact us email enquiries@hta.gov.uk or phone 020 7269 1900.

    You can find out if the matter you wish to complain about occurred at an HTA licensed establishment by searching for the establishment in our directory.

    If it is licensed by us you can raise your concern with this form.

    Most complaints about Pathologists can be dealt with through the doctor’s employers, who will have their own procedures for dealing with complaints. The General Medical Council, which is responsible for ensuring that doctors in the UK have the right knowledge and skills to practise medicine safely, deals with the most serious complaints about a doctor’s practice. The General Medical Council can take action to stop or restrict a doctor’s practice. You can submit a complaint online at www.gmc-uk.org/patient_online_complaints. For further information, or if you wish to speak to an adviser, please telephone 0161 923 6602.

    A complaint about a Coroner’s personal conduct, such as inappropriate behaviour or comments, should be made to the Office for Judicial Complaints (OJC). This incurs no cost and can be done online on the Office for Judicial Complaints website. Alternatively, the complaints form can be downloaded and sent by fax, post or email. The complaint may either be made using the suggested form or by letter or email. The OJC’s contact details are: Office for Judicial Complaints Steel House 11 Tothill Street 3rd Floor, 3.01-3.03 London, SW1H 9LJ, Tel: 020 3334 0145; email: inbox@ojc.gsi.gov.uk; fax: 020 3334 0031; Minicom VII 020 334 0146 (Helpline for the deaf and hard of hearing).

    All complaints about the conduct of deputy coroners and assistant deputy coroners should be sent to the Coroner in writing. If it is considered that the Coroner’s handling of a complaint about a deputy or assistant deputy amounts to personal misconduct of the coroner then that allegation might be referred to the Office for Judicial Complaints. However, the Office of Judicial Complaints could not deal with or determine the actual complaint against the deputy or assistant deputy coroner.

    All complaints about the administration of the coroner service or the conduct of coroners’ officers should be raised first with the relevant coroner, in writing. The letter should also be copied to the local authority which funds the service.

    A complaint may also be made direct to the relevant local authority. If you are dissatisfied with the council’s response, the next step is to complain to the Local Government Ombudsman online, or by calling 0300 061 0614 or 0845 602 1983. Alternatively, a complaint may be made in writing to: The Local Government Ombudsman, PO Box 4771, Coventry CV4 0EH.

    There is no charge to complain about the standard of service from a coroner’s office.

    Cruse Bereavement Care: For help and support you can telephone the Cruse Bereavement Care national helpline on 0844 477 9400 or email helpline@cruse.org.uk. Their website is at: www.crusebereavementcare.org.uk/

    The Lullaby Trust (formerly the  Foundation for the Study of Infant Deaths (FSID)) have a freephone bereavement support helpline - 0808 802 6868.

    INQUEST provides a specialist, comprehensive advice service to bereaved people in England and Wales on contentious deaths and their investigation. www.inquest.org.uk/

    The Ministry of Justice has published a leaflet A Guide to Coroners and Inquests, which can be downloaded from the DirectGov website: www.direct.gov.uk/en/Governmentcitizensandrights/Death/WhatToDoAfterADeath/DG_066713

    Patient Concern is an organisation committed to promoting choice and empowerment for all health service users. They have published a leaflet All you need to know about post mortems, which can obtained by emailing the organisation on patientconcern@hotmail.com or writing to Patient Concern, PO Box 23732, London, SW5 9FY.

    Stillbirth and Neonatal Death charity (Sands) supports anyone affected by the death of a baby and promotes research to reduce the loss of babies’ lives. They have published a range of support and information leaflets at https://www.sands.org.uk/support/bereavement-support

    Their helpline number is 020 7436 5881.

    Northern Ireland

    The HTA regulates post-mortem examination in Northern Ireland although this guidance does not apply there. Updated information for Northern Ireland are available on the Department of Health, Social Services and Public Safety (DHSSPS) website here - https://www.health-ni.gov.uk/publications/hsc-consent-hospital-postmortem-examination-regional-policy.

    Scotland

    The HTA does not regulate post-mortem examination in Scotland and this guidance does not apply there. The Scottish Government’s website provides some general information at www.scotland.gov.uk/Publications/2004/02/18927/33310. You can also call the Central Enquiry Unit on 08457 741 741, or 0131 556 8400; or fax 01397 7950. Alternatively you can email ceu@scotland.gsi.gov.uk or write to General Enquiries, St. Andrew's House, Regent Road, Edinburgh, EH1 3DG.

    The most common organ donated by living people is a kidney, as a healthy person can lead an almost completely normal life with only one functioning kidney. It is also possible for a living person to donate part of their liver (a liver lobe). In very rare circumstances, it may also be possible to donate a segment of a lung and also part of the small bowel. 

    For all forms of living donation, the risk to the donor must be considered very carefully. Before a transplant can go ahead, there must have been a very thorough medical assessment. As with all surgery, there is an element of risk attached.

    More recently there has been discussion of uterus (womb) donation; however, there is currently no programme in the UK. Womb donation is in its experimental stage in the UK and funded by the charity Womb Transplant UK. If you would like to know more about the process please visit the charity’s website.

    For all forms of living donation, the risk to the donor must be considered very carefully. Before a transplant can go ahead, there must have been a very thorough medical assessment. As with all surgery, there is an element of risk attached. 

    Directed donation is a common form of donation where a healthy person donates an organ to a specific, identified recipient with whom they have a genetic or pre-existing emotional relationship. Examples include: a mother donating to son or donation between friends of long standing. These cases are often straightforward, however, some directed donation cases require a higher level of scrutiny by the Human Tissue Authority, for example, where there may be an element of economic dependence e.g. tenant donating to their landlord.

    Paired/pooled donation is achieved through the UK Living Kidney Sharing Scheme (UKLKSS) which is run by NHS Blood and Transplant (NHSBT). The UKLKSS is used in circumstances where:

    • The donor and recipient are incompatible (or mismatched), either by blood group or HLA sensitisation, or
    • The donor and recipient are compatible but are seeking a better age or HLA match

    The pair may be matched to another couple in a similar situation so that both people in need of a transplant receive a matched organ or part organ.

    Pooled donation is where more than two pairs of donors and recipients are involved in the swap.

    All cases of paired and pooled donation are referred to a Human Tissue Authority (HTA) panel of three board Members for decision.

    (image courtesy of NHSBT)


    The HTA’s Code of Practice F on the Donation of solid organs and tissue for transplantation gives more information on the procedures involved. And further information on this scheme is available on the NHSBT website.

    An altruistic donor chain is a form of donation where a non-directed altruistic donor chooses to donate their kidney into the UK Living Kidney Sharing Scheme (UKLKSS). By matching two or more donors and recipients, a chain of donations and transplants can be carried out. The remaining organ at the end of the chain is then donated to the best matched recipient on the national waiting list. This form of donation was implemented by NHS Blood and Transplant in January 2012. 

    If a person is interested in becoming a non-directed altruistic donor, they will need to contact the living donor coordinator (specialist nurse) at their nearest transplant centre.

    Further information can be found on the NHS Blood and Transplant website
     

    An altruistic donor chain is a form of donation where a non-directed altruistic donor chooses to donate their kidney into the UK Living Kidney Sharing Scheme (UKLKSS). By matching two or more donors and recipients, a chain of donations and transplants can be carried out. The remaining organ at the end of the chain is then donated to the best matched recipient on the national waiting list. This form of donation was implemented by NHS Blood and Transplant in January 2012.

    If a person is interested in becoming a non-directed altruistic donor, they will need to contact the living donor coordinator (specialist nurse) at their nearest transplant centre. Further information can be found on the NHS Blood and Transplant website.

    The Human Tissue Authority (HTA) defines directed altruistic using the following criteria:

    1. The donation is being directed to a specific individual, and
    2. There is no evidence of a qualifying genetic relationship or evidence of a pre-existing emotional relationship between the donor and recipient.

    In such cases, there may be an involvement of a third party or media campaign in bringing the donor and recipient together for the purpose of transplantation.

    Examples of directed altruistic donation:

    • Donor and recipient are genetically related, but have no established relationship e.g. cousins, estranged family members.
    • Friend of a friend – the donor and recipient may have an awareness of each other e.g. through a mutual person, but no relationship has been formed between the donor and recipient before the need for a transplant arose.
    • An organisation has campaigned for a donor e.g. a matching website or charity.
    • Media campaigns bring a donor and recipient together e.g. through social media or newspaper articles / adverts.

    These cases are often complex and require a higher level of HTA scrutiny. These cases may be referred to a HTA panel of three board Members for decision.

    Potential donors and recipients considering directed altruistic donation are advised to read:

    Firstly, we would suggest you read as much information as possible about living kidney donation to ensure you understand the medical procedures, the potential risks involved and what the implications are after donation.

    Living Donation information is available to potential donors on the NHS Blood and Transplant Living Donation webpage.

    There is also information available on various charity websites such as Give a Kidney, One’s Enough. Once you have read the information and would like to proceed to the next steps, you should contact the living donor coordinator (specialist nurse) at the nearest transplant centre. Contact details for the transplant teams across the country can be found here.

    Firstly, we would suggest you read as much information as possible about living liver lobe donation to ensure you understand the medical procedures, the potential risks involved and what the implications are after donation.

    Information is available to potential donors on the NHS Blood and Transplant Living Donation webpage.

    There is also information through various charities such as Give a Kidney, One’s Enough. Once you have read the information and would like to proceed to the next steps, you should contact the living donor coordinator (specialist nurse) at the nearest transplant centre. Contact details for the transplant teams across the country can be found here.

    Once you have read the information and would like to proceed to the next steps, you should contact the living donor coordinator (specialist nurse) at the nearest transplant centre.

    The Human Tissue Act 2004 (the HT Act) makes it an offence to give or receive a reward for the supply or offer of human material for transplantation.

    It is unlawful for donors to be paid or rewarded for donating an organ or part organ. Reward, in the context of the HT Act, is a financial or material advantage which induces a person to become a living donor. In practice, reward means any money, gift or other benefit with a financial value, which influences the decision to donate an organ.

    The Human Tissue Authority’s (HTA) role in living organ donation is to ensure that there has been no reward sought or offered for a living organ donation and to provide an independent check to help protect the interests of living organ donors.

    This is achieved through an independent assessment interview process with both the donor and recipient (separately and together). We ensure that each individual donor has an opportunity to speak freely to someone not connected with the transplant centre in order to confirm that their wish to donate is free from any pressure to act against their will.

    Independent Assessors (IAs) are independent of the living donation process and transplant centres and their teams.  IAs undertake the interviews with both the donors and recipients (except in the case of non-directed altruistic donation where only the donor will be interviewed as the recipient will not be identifiable or in circumstances where the recipient may be too unwell). They carry out these interviews on behalf of the HTA and submit a report to the HTA for consideration.

    The HTA makes a decision on whether the living donation and transplant can proceed, based on the evidence provided by the IA.

    It is unlawful for donors to be paid or rewarded for donating an organ or part organ. Reward, in the context of the Human Tissue Act 2004 (The HT Act), is a financial or material advantage which induces a person to become a living donor. In practice, reward means any money, gift or other benefit with a financial value which influences the decision to donate an organ.

    However, the HT Act does permit donors to receive reimbursement of reasonable expenses, such as travel costs and loss of earnings, which are reasonably attributable to and directly result from living organ donation.

    The reimbursement of reasonable expenses incurred as a direct result of living organ donation can be made by the hospital trust; however, the NHS is not obliged to make such payments. Reimbursement of reasonable costs can also be made by other people and organisations.

    It is acceptable for a recipient (or the family of the recipient) to directly reimburse the donor if circumstances necessitate this. In this circumstance, the donor and recipient must be able to provide evidence in order to prove that only direct travel costs were paid for, and that the donor has not materially or financially benefitted in any way.

    Further information about the reimbursement of expenses.   

    The buying or selling of organs or human tissue is illegal under the Human Tissue Act 2004. If convicted of such an offence, the penalty can be imprisonment for up to three years a fine, or both.

    No. The Human Tissue Act 2004 prohibits commercial dealing in all human material for transplants. Most importantly, it makes trafficking of organs, tissue and cells for transplantation an offence. If convicted of such an offence, the penalty can be imprisonment for up to three years; a fine, or both.

    It is not illegal under the Human Tissue Act 2004 (the HT Act) to place an advert seeking a living donor, providing there is no offer of reward/payment or material advantage to the potential donor (commercial dealings in human material for transplants is not allowed).

    It is not illegal under the HT Act for a newspaper to accept and place an advert of this nature, although consideration should be given to whether this is the type of advert the paper wants to run (e.g. it may generate complaints).

    We would encourage those planning to advertise for a donor to proceed with caution and to liaise with your transplant centre about this as early as possible. Transplant centres are not obliged to consider all living donors and this approach may be problematic for the centre (e.g. logistics of working up those who may come forward as a potential donor). Transplant centres may offer advice on the best wording to use in the advert too.

    It is not illegal under the Human Tissue Act 2004 to use social media to seek a living donor provided there is no offer of reward / payment or material advantage to the potential donor (commercial dealings in human material for transplants is not allowed). Anyone considering setting up such a website in the UK is strongly advised to discuss this with the Human Tissue Authority (HTA) (by emailing the transplant team or telephoning 020 7269 1900) before doing so.

    The HTA has issued some guidance to help those who may be considering living donation to a recipient that they have found online, or for those recipients who may be approached by a potential donor via social media.

    We would encourage those planning to use social media to find a potential donor or recipient to proceed with caution. Recipients planning to find a potential donor should liaise with your transplant centre on this as early as possible. Transplant centres are not obliged to consider all living donors and this approach may be problematic for the centre (e.g. logistics of working up those who may come forward as a potential donor). Transplant centres may offer advice on the best wording to use on a social media site.

    It is not illegal under the Human Tissue Act 2004 to setup a matching service, or use one of these services to seek a living donor providing there is no offer of reward/payment or material advantage to the potential donor (commercial dealings in human material for transplants is not allowed). The Human Tissue Authority (HTA) has issued some guidance to help those considering signing up to websites offering a donor and recipient matching service.

    The British Transplantation Society  (BTS) has issued guidance that transplant centres should not accept cases for living donor assessment that arise from websites where potential transplant recipients pay a fee to register their need for an organ transplant. People considering using these websites should be aware that even if a donor were to be found via this route, the transplant community has been advised not to proceed with such cases.

    Transplant centres take the lead on recruiting for new Independent Assessors as they are best placed to judge how many Independent Assessors they need to manage the number of donors and recipients they have. There is a person specification for the role of Independent Assessor which can be found in the Guidance for transplant teams and Independent Assessors.

    More information on Independent Assessors.

    Transplant centres take the lead on recruiting for new Independent Assessors as they are best placed to judge how many Independent Assessors they need to manage the number of donors and recipients they have. There is a person specification for the role of Independent Assessor which can be found in the Guidance for transplant teams and Independent Assessors.

    FInd out more about what Independent Assessors do.

    Once an application form has been received the Human Tissue Authority will request a reference. Once a reference has been received, all applicants are required to undergo training for the role. The Human Tissue Authority generally runs an Independent Assessor training day for new Independent Assessors twice a year (generally in April and November).

    All Independent Assessors are expected to undertake a minimum of two cases every year. Total number of assessments carried out by  Independent Assessors depend on the size of the transplant centre and number of donors and recipients they have.

    Independent Assessors and Living Donor Coordinators are encouraged to work together in order to achieve a good caseload balance. Some Independent Assessors prefer to have dedicated time set aside for independent assessments, while others have more flexibility in their commitments.

    No. Coroners’ post-mortem examinations and the storage of tissue removed during post-mortem examinations do not require consent from the family of the deceased (see section 11 of the HT Act).

    The period of retention is authorised by the coroner. Tissue removed during a coroner’s post-mortem examination may also be seized by the police in the case of a suspicious death. Families must decide whether to proceed with the funeral or request to have the body stored until all tissue is repatriated. This may not always be possible.

    Once the coroner’s authority has ended, it is not lawful to store or use tissue for a scheduled purpose without consent from a person in a qualifying relationship with the deceased. The Coroners Rules require coroners to inform a properly interested person (a role defined under the Coroners Rules) of the options available. These are:

    • for the tissue to be returned for burial or cremation;
    • for the tissue to be disposed of in a lawful manner;
    • for the tissue to be retained for use for research or other purposes, with appropriate consent.

    It is expected that any wishes will be honoured. However, should consent be given for tissue to be stored and used for a scheduled purpose under the HT Act, such as research, but the tissue is deemed unsuitable for this purpose, it should be disposed of. This should be explained in full at the time consent is taken.

     

    They could be. A properly interested person, as defined in the Coroners Rules, is a relative of the deceased whom the coroner notifies that tissue has been retained and to whom the options for dealing with the tissue on expiry of the retention period must be communicated.

    When the coroner’s authority ends, consent under the HT Act is required for storage or use of tissue for a schedule purpose. The person giving this consent must be the person in the highest position in the hierarchy of ‘qualifying relationships’ as defined in the HT Act. This may be a different person from the person with whom the coroner has been in contact.

    Occasionally, a properly interested person or person in a qualifying relationship cannot be located, or is too distressed to discuss the options outlined above. Unless consent is given, tissue should be disposed of in a lawful manner within three months of the expiry of the coroner’s authority (see the HTA code of practice on Disposal, paragraph 54).

    Where consent has been given for tissue to be used for a scheduled purpose but the tissue is determined to be unsuitable for the purpose, it should be disposed of. Consent is not required to dispose of tissue and disposal of tissue does not have to take place on HTA licensed premises.

    Tissue, including that contained in wax blocks, can be disposed of by cremation or incineration. There may be difficulty in cremating slides because practice varies among crematoriums. For more information see the Cremation (England and Wales) Regulations 2008.

    The HTA Code of Practice B (Post-mortem Examination) advises that:

    "Dignified treatment and separate disposal are the minimum considerations when disposing of post-mortem tissue. This means disposal should be carried out separately from clinical waste, but not that each tissue sample needs to be disposed of individually."

    You can read more on disposal of post-mortem tissue in the HTA Code of Practice B (Post-mortem Examination).

    The permission of the coroner must be sought before any removal of tissue for transplantation takes place. The decision lies with the coroner whether the removal of the tissue would affect the results of a post-mortem examination.

    The Human Tissue Act 2004 (HT Act) does not define public display, but the HTA considers public display to be an exhibition or display in which the body of a person, or relevant material which has come from the body of a person, is used for the purpose of being exposed to view by the public.

    Relevant material is defined in the HT Act as material other than gametes, which consists of, or includes, human cells. The definition of relevant material covers bodies, body parts, tissues and cells. Relevant material includes human material which is preserved or treated in any way, but does not include embryos outside the human body, or hair and nail from the body of a living person. The legislative requirements of the HT Act do not apply to bodies or relevant material if more than 100 years have elapsed since the date of the person’s death.

    The HTA’s code of practice on Public display gives examples of scenarios that are and are not considered to be public display.

    No, the remit of the HTA under the HT Act extends to England, Wales and Northern Ireland. Scotland has its own legislation, the Human Tissue (Scotland) Act 2006.

    Under the Human Tissue Act, appropriate consent must be in place for the storage and use of the body of a deceased person, or relevant material from the body, for public display. Consent must be given in writing whilst the person is alive, for their body, body parts and tissue to be stored and displayed after their death. For consent to be valid it must be given voluntarily and by a person who has the ability to make an informed decision. The person giving consent must also have the best information given to them so that they can make their decision.

    Consent in writing is valid:

    • if it is signed by the person concerned in the presence of a witness; or
    • signed at the direction of the person concerned, in his presence and in the presence of a witness; or
    • if the person concerned is an adult, it is contained in the person’s will.

    Consent is also required for the display of relevant material from a person who is still living.

    Further guidance on consent is available in the HTA’s code of practice on Consent and code of practice on Public Display.

    The consent requirements do not apply to the display of human remains from people who died more than 100 years ago.

    The consent requirements also do not apply to imported material. However, it is good practice for any establishment which imports material for public display into England, Wales and Northern Ireland to put in place effective systems to assure itself that human material is obtained with valid consent.

    In addition, consent is not required to display relevant material which was obtained before September 2006 when the HT Act came into force.

    The storage and public display of the bodies of deceased people, or relevant material from their bodies, are activities that are subject to licensing under the HT Act. The duration of the display or the number of items of relevant material on display does not affect the requirement for licensing.

    A licence for public display is not required:

    • to display relevant material from living persons; or
    • if more than 100 years have elapsed since the person’s death; or
    • if the person who provided the material for public display was alive at the time of the donation, including if they have subsequently died.

    If material is stored as part of a museum archive, and there is no intention of ever putting it on public display, a licence is not required (provided the establishment informs the HTA of this intention in writing).

    Please refer to our licence applications, step-by-step guide.

    The HTA evaluates all licence applications on a case-by-case basis before it decides whether or not to offer a licence.

    There are two licensable activities relating to public display:

    1. Storage of the body of a deceased person or relevant material from a human body for a Scheduled Purpose and
    2. The use, for the purpose of public display, of the body of a deceased person, or relevant material which has come from the body of a deceased person.

    Both activities are covered by one licence fee.

    The HTA licensing framework includes a satellite licensing system. Satellite establishments are smaller premises that are under the same governance arrangements as a larger establishment (the hub) and are supervised by the same Designated Individual (DI).

    Further information on satellite premises and licences.

    The HTA will assess whether an establishment can meet a number of licensing Standards. These were developed in consultation with representatives from the Public Display sector. These relate to the consent provisions of the Human Tissue Act 2004 (HT Act), governance and quality systems, traceability and premises. The Museums, Libraries and Archives Council (MLA) sponsored by the Department for Culture, Media and Sport has put in place a national accreditation scheme with standards relating to the management of collections and the needs of users. The HTA’s standards for public display complement the standards set by the MLA.

    The HTA inspects establishments which are licensed for public display. The HTA has published summary compliance reports for the public display sector which summarise compliance with our standards.

    Some establishments store material in an archive with no intention of ever putting the material on public display. If this is the case, the establishment should inform the HTA so that it can take a view on whether or not the establishment has to apply for a licence.

    If no documentary evidence of the age of the material is available, the establishment can seek to establish the age of the material using scientific methods. If scientific methods cannot be applied or do not provide a conclusive answer, the earliest acquisition date or a written statement from an independent expert can be used as evidence of the age of the material.

    If it is not possible to provide such evidence, the establishment will have to apply for a licence.

    Yes – Plastinated tissues are considered to be relevant material and the organisers need to apply for a HTA licence.

    The organisers have to submit a licence application for public display. The HTA has a risk-based approach to regulation and considers the risk of non-compliance by temporary exhibitions to be high. This is because these exhibitions are held on premises which are not designed for the storage and display of human bodies and tissues. The HTA will undertake an on-site inspection of all temporary exhibitions before they open to the public.

    No. Importantly, an HTA licence is for the storage for use in research, not the use itself. Specific research projects undertaken with approval from recognised Research Ethics Committee (REC) committees (or for which approval by such a committee is pending), do not require an HTA storage licence. (This is discussed further below in the question ‘‘Do I need a licence to store tissue or cells for a specific research project if it has ethical approval?’’) In addition, researchers storing tissue samples received from a REC-approved tissue bank do not require a HTA storage licence. Finally, storage that is incidental to transportation or with the intent to render material acellular does not require an HTA licence. More information on the requirements for consent and ethical approval is included in flowcharts within the code of practice on Research.

    No. An HTA licence is not needed for storage of tissue for certain ethically approved research or a specific research project for which ethical approval is pending from a recognised Research Ethics Committee (REC), which is either:

    • a REC established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments, or
    • an ethics committee recognised by the United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004.

    The HTA and National Research Ethics Service (NRES) have agreed a position whereby NHS RECs can give generic ethical approval for a research tissue bank's arrangements for collection, storage and release of tissue, providing the tissue in the bank is stored on HTA-licensed premises. This approval can extend to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored on HTA-licensed premises; nor does it need project specific ethical approval. However, a licence is required for material stored (e.g. in large biobanks) for which there is no ethical approval.

    Yes. They are particularly well-placed to ask for their patients' consent. If they wish to do research without asking their patients' consent, the research project will need to be approved by a recognised Research Ethics Committee (REC) which is either:

    • a REC established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments, or
    • an ethics committee recognised by the United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004.

    Further details are given in the code of practice on Research at. In addition, the researcher must arrange the research so that they do not have access to information identifying the person from whom the tissue came. This does not mean that the records and tissue must be permanently unlinked.

    Yes, consent can be generic and enduring. The HT Act sets the baseline that, for lawful storage and use of tissue for Scheduled Purposes, consent must be obtained from the appropriate person. The scope of that consent is not limited by the HT Act. Guidance for obtaining consent is provided in the HTA’s codes of practice and other documents. It can be whatever is agreed in different circumstances. Anticipating and explaining the purpose for which tissue could be used will avoid the need for seeking repeated consents – for example for research after the patient has had surgery or giving tissue which may be stored for use in a future, unspecified, project.

    No, it doesn’t. The linked data would need to be anonymised so that the researcher could not know the identity of the person whose tissue was involved, but it does not need to be permanently unlinked.

    According to the HT Act, consent from the deceased person, a person nominated by them, or a person in a ‘qualifying relationship’ (usually a family member) will be needed to carry out any research on tissue from the deceased. After coroners have completed their work, the body and tissue must either be:

    • Disposed of sensitively
    • Returned to the family
    • Consented for use for another Scheduled Purpose such as research, clinical audit or public health monitoring.

    An HTA licence is not required if human tissue is stored for a specific research project which has ethics committee approval from a recognised Research Ethics Committee (REC), which is either:

    • a REC established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments, or
    • an ethics committee recognised by United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004, (further details are given in the code of practice on Research at,) or is pending such approval.

    If researchers wish to retain tissue for future, unspecified, research after the expiry of project-specific ethical approval, then a licence under the HT Act will be required. Application for a licence should be made in good time: we recommend at least three months before the ethical approval ends. Alternatively, an application for ethical approval for the new specific research project should be made in good time to preempt the expiry of the project-specific ethical approval. The samples will need to be transferred to existing, licensed premises until either a licence is granted or new, appropriate ethical approval has been obtained.

    Most research institutions and NHS establishments have a licence from the HTA so researchers should be able to transfer human tissue to licensed premises for storage in their own organisation, subject to the agreement of the Designated Individual for the licence.

    Human tissue is a valuable resource for research, and disposal should always be a last resort.

    Whether the storage of tissue requires a licence under the Human Tissue Act (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 an HTA licence is required for storage of the tissue unless a licensing exemption applies. Tissue stored for research that does not have recognised Research Ethics Committee (REC) approval (see above) must be stored under a licence granted by the HTA.

    ‘Residual’ blood or tissue from the living can be used without consent only if the research is ethically approved by a recognised Research Ethics Committee (REC; see above and the code of practice on Research) and the researcher cannot link the blood or tissue to the patient. Consent is needed for any of the HT Act’s Scheduled Purposes where the tissue is from a deceased person.

    Tissues and cells removed directly from a person are relevant material under the HT Act. Cell lines are not relevant material as all the original cells from the person have been replaced by cells that have divided and therefore have been created outside the human body. The storage of cell lines for research under the HT Act does not require an HTA licence.  Primary cell cultures that have divided to an extent that all the original cells have been replaced by new cells created within the culture are also not considered to be relevant material, and so also do not require an HTA licence for storage for research under the HT Act.

    The HTA and National Research Ethics Service (NRES) have agreed a position whereby NHS Research Ethics Committees (RECs) can give generic ethical approval for a research tissue bank's arrangements for collection, storage and release of tissue, providing the tissue in the bank is stored on HTA-licensed premises. This approval can extend to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored on HTA-licensed premises; nor does it need project specific ethical approval.

    Both consent and a licence are needed to store any tissue or cells for the purpose of genetic testing. A licence is not required to store DNA if it is not associated with cells.

    The HTA considers research to be a study which addresses clearly defined questions, aims and objectives in order to discover and interpret new information or reach new understanding of the structure, function and disorders of the human body. Research attempts to derive new knowledge and includes studies that aim to generate hypotheses, as well as studies that aim to test them or develop practical applications or new knowledge. In addition, the HTA endorses the definition provided by the Department of Health and the Welsh Assembly Government, which is as follows: ‘‘Research can be defined as the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.’’
    However, human tissue might be stored and used for another scheduled purpose that might first be thought of as research, for example:

    • Performance assessment:
    This term is intended to encompass use of material in the evaluation and assessment of in-vitro diagnostic kits. This is to make it quite clear, for example, that surplus diagnostic tissue can continue to be used to calibrate and assess the comparative performance of medical devices without specific consent.

    • Quality assurance:
    A programme for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

    This includes separate examination or testing of tissue in order to ensure a high quality service and effective clinical procedures and diagnostic tests. In practice, this term could cover a review of the whole diagnostic process, including checking how information relating to tissue is recorded. The review is not, for example, limited to checking the accuracy of apparatus.

    • Clinical audit:
    A process to review explicit criteria, and the implementation of change, to continuously improve patient care and outcomes.
    This is a means of finding out whether what is being done is appropriate and is being done correctly. For example, are guidelines being followed? Is best practice being applied? Tissue stored in diagnostic archives may need to be reviewed as part of the clinical audit process.

    No. There is no research that has been conducted in the past, or is currently being conducted, that would be prevented by the HT Act. It simply requires consent or, in the case of tissue from the living (including surplus tissue left over after diagnosis or surgery), ethical approval by a research ethics authority and anonymisation. This is wholly in line with current good practice.

    No. The HT Act does not apply to tissue or cells from living people used for diagnosis or blood used for treatment. (So screening for cervical cancer for example is excluded; and an HTA licence is not needed for storage of blood for transfusion.)

    No. Research can take place without patients' consent if the tissue has been anonymised and the project has been approved by a recognised Research Ethics Committee (REC) which is either:

    • a REC established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments, or
    • an ethics committee recognised by United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004, (further details are given in the code of practice on Research at,) or is pending such approval.

    Use of existing tissue holdings (material from the living or deceased that was already held at the time the HT Act come into force on 1 September 2006) does not need legally require consent. However, if practical, the consent of the participant should be sought and the views of the deceased person or of their family (if known) must be respected. In addition, the potential benefits of the research should outweigh any potential harm to donors of the samples. Further details are given in the code of practice on Research. Of interest, although the work on Helicobacter pylori and stomach ulcers was often cited as an example of what could be lost to UK science as a result of the HT Act, this groundbreaking research into the cause of such ulcers actually took place in Australia.

    Browse our map of medical schools that accept body donations. Put in the first two letters of your postcode in the search bar on the left, select the correct postcode from the purple box, then click on the red icon on the map for details of who to contact at your local medical school. Alternatively download our list of medical school contacts (PDF 670 KB)

    Although the new law affecting body donation (the Human Tissue Act 2004) came into force on 1 September 2006, it allows documented and valid consent for body donation made under the old law to be honoured. To avoid any unnecessary confusion or delays after you die, it is recommended that you include an updated intention to donate your body in your Will. More details can be obtained directly from the anatomy establishment to which you wish to donate your body.

    Browse our map of medical schools that accept body donations.

    If you have moved to a new area of the country, but still want to donate your body to the anatomy establishment linked to your old post code, please contact the establishment for more details. Some medical schools may request that your estate contributes to the cost of transporting your body if the donation falls outside of the medical school’s local area. Both the areas covered and contact details of medical schools are available on our medical school finder.

    Medical schools will usually decline a body donation if the person has undergone surgery to remove organs for transplantation. However, if after their death, the person is found unsuitable to be an organ donor, then body donation to a medical school can be taken forward by the relatives, solicitor or executor of the Will; assuming valid consent is in place - please see How to donate your body

    If a person wishes to register for both organ donation and body donation, the HTA suggests that the person includes this in their Will and ensures that those closest to them are aware of their wishes.

    For more information on organ donation please visit the NHS Blood and Transplant website.

    All medical schools welcome the offer of a donation. However, certain medical conditions may lead to the offer being declined. Medical schools can give you more information about these conditions and any other reasons why a body donation may be declined.

    Post-mortem examination (sometimes referred to as an ‘autopsy’) is an important reason why a medical school might decline the offer of a body donation. We recommend that potential donors and their families are prepared to consider alternative arrangements in these circumstances, which can arise unexpectedly. Depending on the circumstances of a person’s death, a Coroner might require, by law, that a post-mortem examination takes place.

    It is important to note that medical schools might not be able to accept donated bodies during holiday periods, such as Christmas.

    If no medical school is able to accept your offer, your estate will need to make suitable funeral arrangements.

    Medical schools may hold committal, memorial or thanksgiving services. Further information can be obtained directly from the medical school.

    Some medical schools may request that the donor’s estate contribute to the cost of transporting the body, particularly if the donation falls outside of the medical school’s local area. Full details can be obtained directly from the medical school.

    The Isle of Man and Channel Islands have no body donation process of their own. It might be possible for a medical school on the UK mainland to accept a body donation from the Isle of Man or Channel Islands, as long as the requirements of the Human Tissue Act 2004 are met.

    If you live in in the Isle of Man or Channel Islands and are considering body donation, you may need to make financial arrangements with a local funeral director in relation to the transportation of your body to the medical school of your choice. To enquire about whether this is possible, please contact the medical school.

    The HTA has no role in regulating anatomy teaching in Scotland. If you live in Scotland and wish to donate your body contact details of medical schools can be obtained from the Scottish Government.

    Body donations are required for training and education worldwide so you may wish to consider donating your body in your current country of residence.

    Where ‘anatomical examination’ is concerned, the Human Tissue Act 2004 (the ‘HT Act’) does not apply in areas outside England, Wales and Northern Ireland. However, the HT Act does allow ‘imported’ bodies and other human material to be stored and used for anatomical examination in England, Wales or Northern Ireland. Although imported bodies and material are exempt from the HT Act’s requirements for consent, death certification and registration, a medical school might ask potential donors to follow their usual consent procedures before a donation may be accepted. It is possible that anatomy establishments might not want to accept donations from people who have died abroad. 

    No. The Human Tissue Act requires a positive decision to be made by the person, themself, before their death.

    From 7 April 2006, the European Commission required that Members States bring into force the laws, regulations and administrative provisions necessary to comply with the Parent Directive (Directive 2004/23/EC). In order to comply with the European Directive the HTA commenced licensing the storage of human tissues and cells for transplantation on 7 April 2006.

    Alongside the commencement of licensing the HTA issued Directions (Directions 001/2006), summarising the requirements of the Parent Directive and the first technical Directive (Directive 2006/17/EC) to licensed establishments. All establishments were required to comply with Directions 001/2006 by April 2007.

    The Parent Directive, the first technical Directive and the second technical Directive (Directive 2006/86/EC) were formally adopted into UK law on 5 July 2007 via a statutory instrument called 'The Human Tissue (Quality and Safety for Human application) Regulations 2007, in short 'the Regulations'.

    The HTA issued a second set of Directions (Directions 002/2007), which set out the requirements of the Regulations and the second technical Directive of the EUTCD and supplement and amend the first set of Directions.

    The HTA issued a further set of Directions (Directions 004/2007) which came into force on 7 October 2007. These Directions stipulate that imports of tissues and/ or cells from non-European Economic Area (EEA) states meet standards of quality, safety and traceability equivalent to those provided in the Regulations.

    The HTA issued Directions 003/2010 which came into force on 12 November 2010. These Directions consolidate and clarify the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007. These Directions revoke Directions 001/2006, 002/2007 and 004/2007.

    The HTA issued Directions 002/2018 which came into force on 1 April 2018. These Directions implement the HTA consolidated requirements for human application licences and third party agreements. The requirements are set out in version 2 of the “Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment” which forms the Annex to these Directions. The Guide will be the primary reference for establishments and will be subject to periodic updates. These Directions revoke Directions 003/2010.

    The activities of import and storage of human tissues and cells for human application can only lawfully take place if the establishment is licensed to carry out these activities. However, the following activities may lawfully be carried out either under a licence or under a third party agreement with an establishment licensed to carry out activity/ies relating to tissue and cells for human application:

    • Procurement
    • Testing of donor samples
    • Processing
    • Export
    • Distribution

    N.B. Anyone carrying out the above activities and storing material for more than 48 hours must be in possession of a storage licence.

    If an establishment held a licence to store relevant material for transplantation under the Human Tissue Act 2004, they were automatically considered to be licensed under the Regulations to carry out the activities listed below with regards to tissues and cells for human application:

    • Procurement
    • Testing of donor samples
    • Processing
    • Storage
    • Import / export
    • Distribution

    This meant that establishments were no longer licensed to store tissues and cells for human application under the HT Act but are licensed to do so under the Regulations. However, establishments continue to be licensed under the HT Act for storage for scheduled purposes other than transplantation/human application e.g. establishments are still licensed under the HT Act to store human tissue for the scheduled purpose of research.

    If you are procuring on behalf of an establishment that has a licence to procure tissues and cells for human application and you have a third party agreement in place with them to carry out this activity, you will not require your own HTA licence. Otherwise, a licence will be required to carry out this activity.

    You will need the third party agreements with anyone who:

    • carries on a licensed activity (other than import or storage), on behalf of the licensed establishment or
    • supplies to the licensed establishment any goods or services which may affect the quality or safety of tissue or cells.

    The HTA has issued a Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by Directions (Directions 003/2010) setting the standards for third party agreements.

    An EEA state is a state within the European Economic Area. These include all EU states and Iceland, Liechtenstein, Gibraltar and Norway.

    Yes. The role of the Designated Individual changed under the Regulations. Under the Regulations the DI needs to possess a formal qualification in a medical or biological field or be considered appropriate by the Authority on the basis of other qualifications and experience. The DI also needs at least two years practical experience in a relevant field. There are also additional duties under the Regulations. The duties of the DI are set out in regulation 12 of the Regulations and are as follows:

    • that persons to whom the licence applies are suitable persons to participate in the carrying-on of the licensed activity,
    • that suitable practices are used in the course of carrying on that activity, and
    • that the conditions of the licence are complied with
    • that the conditions of third party agreements, in relation to the licensed activities authorised to be carried on under his supervision are complied with
    • that the requirements regarding information and confidentiality (including traceability) of tissues and cells set out in regulation 13(1) are complied with

    The role of Licence Holder has changed under the Regulations. The Regulations require that third party agreements are made by the Licence Holder or on his behalf by the DI meaning that the Licence Holder needs to have involvement in making these agreements. The Licence holder is also be responsible for ensuring compliance with Directions issued under the Regulations.

    Through measures set out in Commission Directive (EU) 2015/565 (the coding Directive) all establishments licensed in the human application sector will be included in the EU Coding Platform.

    The EU Coding Platform contains two compendia:

    • the EU Tissue Establishment (TE) Compendium - this contains information on all tissue establishments authorised in the EU; and 
    • the EU Tissue and Cell Product Compendium – this contains categories of tissue and cell product codes.

    All establishments that hold an HTA human application licence are listed in the TE compendium. This platform includes information on:

    • the activities that an establishment is licensed to undertake; and
    • the tissue and cell types that an establishment is authorised to undertake these activities for.

    It is the HTA’s responsibility to keep the TE compendium up to date and to make any updates required. Establishments should check that their information, as listed in the TE compendium is accurate and notify the HTA if any of the information appears to be incorrect.

    As a standard condition of HA licences, all establishments are required to notify the HTA of changes in licensable activity, or if they wish to start working with a new tissue type. Once these changes have been authorised, the HTA will update the TE compendium within 10 working days. 

    If you are only storing tissues or cells for human application and they are stored for less than 48 hours a licence is not required. Please note if you carry out any of the activities listed below then they will need to be carried out under a licence or a third party agreement with an establishment licensed to carry out activity/ies relating to tissues and cells for human application by the HTA:

    • Procurement
    • Testing of donor samples
    • Processing
    • Export
    • Distribution

    N.B. as with storage, the activity of import can only lawfully take place if the establishment is licensed to carry out this activity.

    Yes, the HTA regulates the procurement, processing, storing, donor testing, distribution and import / export of DLIs.

    Human bodies are used to teach students and to train surgeons and other healthcare professionals. We license and inspect organisations, such as medical schools, that carry out these activities in England, Wales and Northern Ireland. We do this to provide assurance to the public that bodies or tissue from the deceased are given with proper consent, and are used appropriately.

    As the regulator, the HTA cannot promote body donation but we do provide the public with support and information about body donation. People must decide, and provide written and witnessed consent before they die, if they would like to donate their bodies to medical science.

    Living donation of bone marrow and peripheral blood stem cells

    We regulate, through an independent assessment process, the donation of bone marrow and peripheral blood stem cells from living children and adults who lack the capacity to consent. We work hard to ensure that valid consent has been given so that those donating understand any risks, donate of their own free will and that no reward is sought or offered.

    Licensing quality and safety of tissue and called for treatment

    We also issue licences, across the UK, under the EU laws, which ensure the quality and safety of tissue and cells - including bone marrow and peripheral blood stem cells - used for patient treatment.

    A post-mortem examination is a study of a body after death, usually carried out if the cause of death is unknown, sudden or unexpected, and ordered by a coroner. Sometimes it may be carried out at the request of the hospital to find out more about their the patient’s illness or why they died.

    In England, Wales and Northern Ireland, mortuaries where post-mortem examinations take place are licensed and inspected by the HTA. We help mortuaries improve the standard of care they provide, so the public can have confidence that deceased people are treated with dignity and respect.

    We also provide advice and information to the public to help them make decisions about what should happen to organs and tissue samples that were removed for further examination, after the cause of death has been ascertained. In regulating post mortem examination, we work closely with coroners and pathologists. However, we do not regulate their professional practice.

    Under EU law, the HTA licenses organisations across the UK to ensure the quality and safety of tissue and cells used to treat patients, from donation through to use in treatment. We issue these licences to a wide variety of establishments, including eye banks (corneas), establishments storing umbilical cord blood, and organisations storing skin and bone to treat burns or bone injuries, and stem cells. We have a similar role for organs intended for transplantation.

    Stem cells have the potential to become medicines for wider use. We work closely with other regulators to help organisations to achieve this potential. We licence establishments, and do not regulate individual clinicians or healthcare professionals.

    Organs – including kidneys, liver, lung and pancreas - are transplanted into patients to save and improve the quality of life. Under EU law, the HTA licenses organisations across the UK to ensure the quality and safety of organs that are intended for transplantation. We have a similar role for tissue removed for patient treatment.

    We do not promote organ donation. That is the role of NHS Blood and Transplant. We license establishments, and do not regulate individual clinicians or healthcare professionals.

    Human bodies and body parts may be put on public display, in exhibitions and museums. In the UK, any person wanting to donate their body for display must give their consent while still alive. We provide assurance to the public that bodies or tissue from the deceased that are displayed to the public are handled with care and treated with respect. Any organisation involved in public display must be licensed by the HTA, unless the remains come from people who died more than 100 years ago. The HTA does not license the display of photographic or electronic images.

    Human tissue can be studied to improve our understanding of health and disease. We want to see good research thrive in the UK. We believe that good regulation supports good science, which in turn leads to improved healthcare. The term ‘research’ is often used to mean a wide range of activities which might be laboratory - or treatment-based. The type of research regulated by the HTA is perhaps best thought of as ‘laboratory bench’ research. We ensure that this tissue is removed and stored in an appropriate and well managed way.

    We license organisations for removal and storage for research in England, Wales and Northern Ireland. Our licensing role in research is limited to licensing premises - such as tissue and brain banks - storing tissue from the living and deceased. We also license establishments - including post mortem establishments - where tissue is removed from the deceased for research.

    We do not license the ‘use’ of tissue for research or approve individual research projects or clinical trials. Neither do we have a role in the ethical approval of research. We do, however, work in partnership with other organisations to ensure that the regulatory environment is easy for researchers to navigate and understand.

    Although the Act requires that removal of tissue from the deceased for research is licensed, its storage can be exempt from licensing. A lot of tissue stored for research is automatically exempted from licensing and consent requirements, because it comes from living people and there is project-specific approval from a recognised Research Ethics Committee.

    Anatomical examinations, public display of material from the deceased, post mortem examinations, removal of post mortem material, storage of post mortem material, storage of anatomical specimens, and storage of material from a living person for a scheduled purpose (e.g. other than for diagnosis). Full details are in Annexes A and B of the Guide to Licensing for Designated Individuals and Licence Holders.

    Those establishments who intend to conduct the activities specified above. The applicant for the Licence Holder could be the Designated Individual (DI) who has responsibilities under the Human Tissue to ensure good practice is followed and licence conditions are complied with. Alternatively, as opposed to an individual, the Licence Holder could be a corporate body (e.g. an NHS Trust) providing the named DI has consented to the application. The licence will be held by the Licence Holder (if different from the DI). For further information please see the Guide to Licensing for Designated Individuals and Licence Holders.

    The Human Tissue Act 2004 covers England, Northern Ireland and Wales. Scotland has its own legislation covering human tissue - the Human Tissue (Scotland) Act 2006. The Human Tissue Regulations 2007 cover England, Northern Ireland, Wales and Scotland. Establishments in Scotland carrying out activities relating to tissues or cells for human application; may require a licence from the HTA. Please see the Quality and Safety Regulations FAQs for more information. The other activities which the HTA licenses do not apply in Scotland.

    This depends on the governance responsibilities for the establishment. More information is provided in the Guide to licensing for Designated Individuals and Licence Holders.

    In this situation, it may not be necessary for an establishment to hold two separate HTA licences (for example, one for storage of tissues and cells for human application and another for storage of relevant material for use in a scheduled purpose) as the HTA can grant a licence that authorises both activities.

    However, if only one licence is granted, a single Designated Individual is responsible for ensuring that suitable practices and systems are in place for both activities. If the DI only has limited oversight of either activity, this arrangement may not be appropriate.

    If you unsure whether to apply for a single licence or multiple licences, please contact the HTA for advice.

    If you discover an unlicensed activity please advise the relevant organisation to look at our website to find out more about our licensing processes and whether they need a licence, and if they are still unclear please tell them to contact us directly for advice. If the establishment doesn't contact us and doesn't apply for a licence, you may wish to advise the unlicensed centre that you would like to give their details to the HTA so we can contact them directly to offer more focused advice and guidance.

    The licence fee structure for all sectors is available on the fees and payment page.

    The DI will have responsibility to ensure compliance with conditions on their licence, one of which relates to fees. The Licence Holder should pay any relevant licensing fee, as determined by the Authority.

    Unless otherwise agreed, licences are continuous and remain in place until revoked.

    Licence conditions are actions which must be achieved (sometimes within a prescribed timescale) to reach the required standards.

    Conditions are statutory, standard or additional. Statutory conditions are set out in the HT Act and the Human Tissue (Quality and Safety for Human Application) Regulations 2007. Standard conditions are applied to all licences (or a sub-set of them) by the HTA. Additional conditions are specific to a licence.

    Depending on the licensable activity there could be 10 statutory conditions. There may be 6-18 standard conditions. There could be as many as 10 additional conditions.

    Yes, the HTA has the power to impose conditions on specific licences where it feels this is appropriate. If it does so, the HTA has to provide a written notice to the DI (and the Licence Holder, if different) and allow an opportunity for them to make representations within 28 days of being notified. The conditions are intended to help the sectors meet the required standards and we will share best practice with the sectors.

    Yes, this is known as a licence variation. We can envisage circumstances where licences may be varied, for example if the DI leaves or otherwise cannot fulfill their duties. Provided an application is made to the HTA we will consider varying the existing licence. Application forms to vary a licence can be found at changes to your licence.

    Yes, for example, if we believe that any information provided within the application was in a material way either false or misleading, if we find that the DI cannot discharge their duties, or if we are no longer satisfied that the licensed premises are suitable for the purpose. There is also scope for either the applicant or the DI under a licence to ask the HTA to revoke their licence.

    There are two stages: representation and formal appeal. The HTA will produce standard operating procedures for both these processes.

    If the HTA decides either to grant, revoke or vary a licence when an application has been made to do so, or otherwise decides to impose special conditions, we must advise the applicant giving our reasons. At that point the applicant has the right to ask the HTA to reconsider the decision, provided they give written notice within 28 days of being notified of the original decision. This would be in the form of representations.

    If the applicant is not satisfied with that decision s/he can make an appeal against it. The HTA Appeals Panel will be comprised of five Authority members who have not taken any part in the original licensing process.

    Not necessarily, however the HT Act requires the licensed activity to be carried out under the supervision of the DI. The DI can designate others as being covered by the licence by providing written notice to the HTA, provided they are satisfied that that person is suitable to undertake the activity.

    However the Human Tissue (Quality and Safety for Human Application) Regulations 2007 do require that the DI has certain qualifications, pease see information for DIs and Licence Holders under the Regulations for more information.

    The Person Designated (PD) by the DI is able to direct in relation to licensable activities. We see the role of the PD as supplementary to that of the DI in the governance framework, although the DI remains responsible for supervising the activities to be authorised by the licence. The PD could act at a local level to support the DI. This could be, for example, to advise other persons to whom the licence applies about the procedures and systems agreed by the DI that ensure compliance with the HT Act. It may be appropriate to have the processing manager and the quality manager as the PDs. 

    No - not normally. The PD is a part of the statutory governance framework required by the HT Act to ensure compliance with the conditions of the licence. It would rarely, if ever, be the case that a forensic or other visiting pathologist would be in that position.

    For further information about the roles of the DI and PD, please see the Guide to licensing for Designated Individuals and Licence Holders.

    The HTA will be conducting site visits according to risk. Some site visits will be based on the risk apparent in the completed application and others will be selected on a random basis to assess if they are compliant with our requirements under the HT Act. Establishments regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 will be inspected at least once every two years.

    The HTA will appoint individuals to perform site visits. Our aim is to work collaboratively with other regulators and we may seek to delegate the inspection function or work together with another inspectorate.

    The HTA will work with you to advise how you can meet the required standards. In extreme cases we may not be able to grant you a licence or where a licence has already been issued we may revoke it. More usually we will place conditions on a licence to limit your practice or to require an improvement in standards.

    An online tool-kit has been developed by the Department of Health and the Medical Research Council in conjunction with regulatory authorities, including the HTA. It describes the necessary arrangements to be made following choices specific to each project.

    The Human Fertilisation and Embryology Authority (HFEA) regulates the use of gametes and embryos for use in fertility treatments and research. An HFEA research licence is required for any activity involving the use of an embryo for research. Therefore, an HFEA research licence must be in place before an embryo can be used for the purpose of creating cell lines. Once a cell line has been created it is a condition of an HFEA research licence that a sample line is deposited in the UK Stem Cell Bank. At this point the HFEA’s regulatory remit ceases.

    The HTA’s regulatory authority commences at the point the embryo is disorganised and cells are grown to create cell lines with the intention that the lines may at some future time be used in human application. Therefore, any organisation processing, testing, storing and distributing human embryonic stem cell lines with the intention that they may be used in patient treatment may only do so under the authority of an HTA licence.

    Under the Regulations, the HTA is responsible for ensuring that any tissues or cells intended for patient treatment conform to the requirements of the EUTCD. A consequence of this is that the HTA will require evidence to show that a human embryonic cell line intended for patient treatment was procured in accordance with the Directives, and that the environment in which the source materials (i.e. the gametes and resultant embryo) were processed, complied with the technical requirements of the Directives.

    At the time of procurement the primary intention is to procure gametes to create viable embryos for use in fertility treatment. However, if a cell line from a donated embryo is created with the intention that it will be used in human application, the HTA requires evidence that the procurement of the source materials (i.e. the gametes) complied with the requirements of the Directives. Therefore, compliance with standards for the consent, donor selection criteria, parental viral screening and traceability will ensure that procurement has taken place in accordance with the Directives. A failure to comply with the procurement requirements of the Directives may prevent the future use of the cells in patient treatment.

    The EUTCDs set very specific standards regarding the environment within which human tissues and cells must be processed if they are to meet the standards of quality and safety required for use in human application. These standards apply to any processing carried out on a cell line created from an embryo and also to the source materials from which the cell line was created i.e. the gametes and embryo.

    In particular, if tissues or cells are exposed to the environment during processing, the air quality must meet particle count and microbial colony count standards that are equivalent to those of Grade A, with a background environment at least equivalent to Grade D (see HTA Directions 002/2018 paragraph 40). Tissues or cells not processed in a Grade A against D background must be stored separately and a risk assessment carried out to ensure that they meet suitable standards of quality and safety for use in patient treatment.

    The Human Tissue Act 2004 licenses (amongst other activities) the storage of relevant material for use for research. The Human Tissue Act explicitly excludes from its remit the licensing of material if it is created outside the human body. Therefore, the regulation of cell lines for research falls outside of the HTA’s remit.

    Cell lines that are European Union Tissue and Cells Directive (EUTCD) compliant should be stored separately from those that are not to avoid any potential contamination issues.

    Any establishment in the UK that carries out certain activities in relation to cell lines for patient treatment requires either a licence from the HTA under the Quality and Safety Regulations 2007 or have a third party agreement (TPA) in place with an establishment that is licensed by the HTA. Procurement is one of these activities, but for human embryonic stem cell lines this activity is licensed by the HFEA. The other activities that require either a licence or TPA are:

    • testing;
    • processing;
    • import / export; and
    • distribution.

    Any establishment storing cell lines in the UK for human application may only lawfully carry out this activity if licensed to do so by the HTA under the Regulations. Storage, unlike the above activities cannot be carried out under a third party agreement.

    Licence applications should be made online. Guidance can be found on our website.

    Anyone holding bodily material without the consent of the person/s concerned, intending to analyse the DNA and to use the results, could be breaking the law. It is an offence to analyse DNA without qualifying consent (unless it is for an excepted purpose) and could lead to a fine, a term of imprisonment of up to three years, or both.

    S45 and Schedule 4 of the HT Act set out the provisions regarding DNA. However, where relevant material is removed from a body or stored for the purpose of DNA analysis, the scheduled purposes in Schedule 1 of the HT Act may also apply.

    There are also provisions regarding analysis of DNA in circumstances where consent is not needed as a result of incapacity. These are found in  regulations 5, 6 and 7 of  The Human Tissue Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (S.I. 1659)

    It is necessary for someone to meet BOTH of the following:

    1. be in possession of bodily material intending that DNA in the material be analysed without qualifying consent, AND;
    2. that the results of the analysis of DNA be used for something other than an excepted purpose.

    As both tests must be met for the offence to be committed, this means that if one of them is not, there is no offence; i.e.

    1. If someone has qualifying consent, then ANY analysis of DNA can take place and the results of that analysis can be used for ANY purpose;
    2. If there is NO qualifying consent, the DNA can still be analysed and the results used, BUT ONLY where the use is for an excepted purpose;
    3. If there is no qualifying consent and the results of analysis of DNA are for something which is not an excepted purpose, then an offence is committed.

    Bodily material is material which:

    1. has come from a human body, and
    2. consists of or includes human cells

    DNA in itself is not bodily material so someone holding extracted DNA does not commit an offence under the Act if they analyse it and use the results.

    This depends on the origin of the material; the excepted purposes are found in Schedule 4 to the Act (see Appendix 1).

    This depends on whether it relates to living or deceased, adult or child and is defined in Schedule 4 (see Appendix 2)

    Yes:

    1. if the person who has the material is not in possession, and not likely to come into possession, of information from which the person from whom the material came could be identified; in this case, the results can be used for any purpose and consent is not required; or
    2. it is used for one of the excepted purposes listed below (as for imported material):
      1. clinical audit;
      2. determining the cause of death;
      3. education or training relating to human health;
      4. establishing after a person’s death the efficacy of any drug or other treatment administered to him;
      5. obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person);
      6. performance assessment;
      7. public health monitoring;
      8. quality assurance;
      9. research in connection with disorders, or the functioning, of the human body;
      10. transplantation.

    This means that if you have an existing holding of bodily material and hold information that allows the donor to be identified, you can only use the results of analysis for an excepted purpose, UNLESS you seek qualifying consent from the donor.

    Note: ‘Existing holding’ means bodily material held immediately before the day on which the HT Act came into force, 1 September 2006.

    All companies providing DNA testing kits or DNA testing services must comply with the provisions of the Human Tissue Act 2004 relating to consent and the holding of bodily material with the intent to analyse DNA.

    Section 45 applies to ‘bodily material’, which is material that has come from a human body and consists of or includes human cells. However, for the purposes of the Act, material is not regarded as being from a human body if it is created outside the human body (Part 3(7).  It follows that cells lines that do not contain primary cells are not bodily material and the Section 45 requirements do not apply. Cell lines containing primary cells are considered bodily material.

    DNA testing companies may not always need an HTA licence. This is because DNA is not ‘relevant material' (which consists of or includes human cells). If establishments hold material (tissues and cells) from which DNA comes, then an HTA licence may be required. If tissues and cells are held for only a short period prior to being rendered acellular as part of the process by which DNA is obtained, then an HTA licence may not be required. Advice should be sought from the HTA.

    Yes, by implication, if relevant material is removed from a body to undertake DNA analysis for a reason that falls within this scheduled purpose, i.e. if it is to obtain scientific or medical information which may be relevant to another person.

    Yes, as this is information ‘which may be relevant to any other person’. However, use of the results DNA analysis for the purposes of functions of a coroner (which includes identification of a deceased person) is use for an excepted purpose. There may be issues in relation to mass disasters overseas where there is no coroner’s jurisdiction in the UK.

    Yes, as this is information about a living or deceased person which is relevant to another person.

    The consent requirements for DIY Paternity testing kits are the same as those for any other kind of DNA analysis. As long as the consent requirements of the Human Tissue Act 2004 are met, the sale of DNA testing kits and their effectiveness are not matters for the HTA.

    No, the removal of relevant material from the body of a deceased person for use for a scheduled purpose needs appropriate consent (as defined in the Act and including the hierarchy of qualifying relationships).

    Paternity tests fall within the definition of ‘obtaining scientific information….’ as detailed above. This is NOT an excepted purpose, EXCEPT in relation to existing holdings. In relation to any other material it is a scheduled purpose. Therefore:

    1. If it is in relation to an existing holding, paternity testing can be carried out (with or without consent or knowledge of identity, as it is use for an excepted purpose).
    2. If it is in relation to the living, appropriate consent is needed for the use of relevant material for paternity testing.
    3. If it is in relation to the deceased, appropriate consent is needed for the removal of relevant material from the deceased for use for paternity testing and for the use of the material for testing.

    That means that in the situation where someone gives qualifying consent for analysis of DNA under s 45 (e.g. the adult child of a deceased person) but a person higher up the hierarchy does not give consent to the removal of relevant material from the body of the deceased, NO removal can take place, and therefore no testing can take place.

    Use for excepted purposes (see Appendix referred to above).

    The Authority (or Court of Session in Scotland) has power to permit the use of results of analysis of DNA in the absence of consent.

    For adults who lack capacity to consent (England and Wales, and Northern Ireland) or adults with incapacity (Scotland) with such an adult referred to here as “P”, the purposes for which DNA may be analysed are:

    England and Wales

    (a) any purpose which the person carrying out the analysis reasonably believes to be in P’s best interests;
    (b) the purposes of a clinical trial which is authorised and conducted in accordance with the clinical trials regulations;
    (c) the purposes of intrusive research which is carried out in accordance with the requirements of section 30(1)(a) and (b) of the Mental Capacity Act 2005 (approval by appropriate body and compliance with sections 32 and 33 of that Act);
    (d) the purposes of intrusive research—

        (i) which is carried out on or after the relevant commencement date,
        (ii) in relation to which section 34 of the Mental Capacity Act 2005 (loss of capacity during research project) applies, and
        
    (iii) which is carried out in accordance with regulations made under section 34(2) of that Act; or

    (e) research which is carried out before the relevant commencement date and which, before that date, is ethically approved within the meaning of regulation 8 of The Human Tissue Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (S.I. 1659) .

    Northern Ireland

    (a) any purpose which the person carrying out the analysis reasonably believes to be in P’s best interests;
    (b) the purposes of a clinical trial which is authorised and conducted in accordance with the clinical trials regulations; or
    (c) research which is ethically approved within the meaning of regulation 8 of The Human Tissue Act (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (S.I. 1659).

    Scotland

    (a) any purpose for which the person carrying out the analysis has obtained the consent of any person who has authority to consent to analysis of P’s DNA by virtue of—

        (i) a welfare power of attorney within the meaning of section 16(2),
        (ii) an intervention order under section 53, or
        
    (iii) a guardianship order under section 58,

    of the Adults with Incapacity (Scotland) Act 2000;

    (b) a clinical trial which is authorised and conducted in accordance with the clinical trials regulations; or
    (c) surgical, medical, nursing, dental or psychological research which is permitted under section 51 of the Adults with Incapacity (Scotland) Act 2000.

    Yes the provisions of s45 do. There are some variations in relation to consent (particularly regarding children) for this purpose. However, the foregoing information in relation to removal for scheduled purposes does not apply in Scotland.

    Schedule 4 para 11 states that ‘Use of the results of an analysis of DNA for a purpose specified in paragraph 7 is use for an excepted purpose if the use in England and Wales, or Northern Ireland, for that purpose of the bodily material concerned is authorised by section 1(1) or (10)(c)’.

    Section 1(4) of the Act makes it clear that section 1(1) (which relates to appropriate consent) of the Act does not apply to imported bodies or relevant material. Therefore, the use of the results of analysis for any of the purposes in paragraph 7 of Schedule 4 would be excepted purposes and therefore no offence would be committed if consent had not been obtained. Those purposes are:

    1. clinical audit;
    2. determining the cause of death;
    3. education or training relating to human health;
    4. establishing after a person’s death the efficacy of any drug or other treatment administered to him;
    5. obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person);
    6. performance assessment;
    7. public health monitoring;
    8. quality assurance;
    9. research in connection with disorders, or the functioning, of the human body;
    10. transplantation.

    As stated above, this would therefore include use of the results for genetic or paternity testing. Also, import is into England, Wales and Northern Ireland so material imported from Scotland falls under this category. The HTA would always state that seeking confirmation of consent for any use in relation to imported material is good practice.

    Tissue from the living

    The consent provisions in Part 1 of the HT Act do not apply to the removal of tissue from living people for scheduled purposes, and therefore considerations about the purpose of the removal and whether consent is required are not necessary. With regard to the analysis of DNA, the s45 offence needs BOTH a lack of qualifying consent and use for something other than an excepted purpose. The excepted purposes set out in Schedule 4 include (i) the prevention and detection of a crime and (ii) the conduct of a prosecution. Therefore police analysis of DNA for their purposes does not require the consent of the person from whom the DNA was obtained.

    Tissue from the deceased

    In relation to removal of tissue from the deceased and subsequent DNA analysis; the removal of the tissue falls within the scope of the consent requirements but they will not apply because (a) the removal will not be for a scheduled purpose or (b) authority will have come from HM Coroner. As above, the excepted purposes for police activities apply to the use of the results

    The HTA has a statutory duty under section 15(b) to provide ‘in relation to activities within its remit such general oversight and guidance as it considers appropriate’ and under section 15(d) to provide ‘to the public, and to persons carrying on activities within its remit, such information and advice as it considers appropriate about the nature and purpose of such activities.’ The HTA has taken the approach that requests for information and guidance on the legal interpretation of DNA falls within its remit.

    However, the HTA's does not have a role in enforcement or prosecution and it is for police and the Crown Prosecution Service to consider whether to prosecute should they discover evidence that an offence has been committed.

    In most cases it is illegal to carry out DNA testing, including paternity testing, without consent. Members of the public should contact the police if they suspect the law has been broken.

    Paternity testing falls within the definition of ‘obtaining scientific information….’ as detailed above. It is a Scheduled Purpose under the Act, and (in relation to DNA analysis) is only an Excepted Purpose if the material is an existing holding, which is not the case here.

    Removal of  material from the deceased for use for a Scheduled Purpose requires “appropriate consent” under s1 of the Human Tissue Act 2004. In the absence of consent of the deceased in life  this would be  the consent of his nominated person, or the consent of the highest ranking person in a qualifying relationship. If a person had stated in life that he would not give consent for material to be removed for use for a scheduled purpose, then this decision cannot be overruled.

    In the situation above, the partner is highest in the qualifying relationship and thus can give appropriate consent for removal of tissue for use for a Scheduled Purpose. As there is no hierarchy in the qualifying relationship when applied to the need for qualifying consent, she can also give qualifying consent for analysis of DNA under s45. The son’s objection cannot veto this, but the HTA would always suggest that discussion between family members takes place in an attempt  to reach a  common decision.

    The removal of bodily material for use for the Scheduled purpose of ‘obtaining scientific information . . .’ needs appropriate consent. Assuming that the consent of the deceased (or his refusal to consent) has not been recorded, and assuming he had not nominated someone to consent on his behalf, then appropriate consent would be from the highest ranking individual in the hierarchy of qualifying relationships, in this case the widow of the deceased. If she refuses to consent then no removal for use for the scheduled purpose can take place.

    If, however, the son holds some bodily material of his father, then he can give qualifying consent for that sample to be analysed and the results used for the testing he wishes to be undertaken.

    In the absence of qualifying consent, the results of DNA analysis can only be used for the excepted purposes detailed in Appendix 1 paragraph 5 (below). The excepted purpose of the functions of the coroner only relates to identification of the deceased and determining cause of death.

    Obtaining scientific information (either in relation to paternity testing or the presence of a genetic disorder) is not an excepted purpose. If analysis to determine the presence of a genetic disorder was relevant to determining the cause of death, this would fall under the excepted purpose of the functions of a coroner, although it would be a matter for the coroner to determine whether or not he would authorise the use of the material for this purpose.

    This material may be ‘excepted material’ the definition of which is:

    1. material which has come from the body of a person who died before the day on which this section comes into force and at least one hundred years have elapsed since the date of the person’s death,
    2. an existing holding and the person who has it is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified.

    In either case, the offence provisions of s45 do not apply so the results of analysis could be used for any purpose.

    This depends on circumstances. There are two genetic tests here; one on the husband and one on the child.

    Husband: the client holds bodily material and she wishes to use the results of DNA analysis used to obtain ‘scientific information’ about her husband. This is not an excepted purpose and so can only be carried out with qualifying consent. If the husband is alive and competent, this would be his consent. If the husband has died, qualifying consent can be from anyone in a qualifying relationship, so she could consent and the analysis results could be used in relation to paternity testing.

    Child: as above, the use of bodily material to obtain ‘scientific information’ requires appropriate consent. In the case of child, this would be the consent of the child or (if he is not competent to consent or chooses not to make a decision) someone in a parental relationship.

    Only with qualifying consent. In the absence of qualifying consent the results of analysis of DNA can only be used for excepted purposes. Research into the disorders and functioning of the human body is not an excepted purpose. Such research can become an excepted purpose if subject to an order by the High Court or Court of Session.

    However, if appropriate consent has previously been obtained to use the samples for research which includes the use of DNA or does not prohibit that use, then that would also be suitable as qualifying consent.

    Also, if subsequently, recognised ethical approval was obtained again, then, provided the samples are from the living, and the researcher is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified, the use of the results of an analysis of DNA for the purpose of research in connection with disorders, or the functioning, of the human body is use for an excepted purpose, and no qualifying consent would be required.

    Yes, because research in connection with disorders, or the functioning, of the human body is use for an excepted purpose in relation to material that has been imported, and therefore consent is not required for analysis of the DNA.

    In some cases, it may be possible that a third party's DNA may be found on bodily material to be tested. Where that is known to be a possibility, that person's consent should also be obtained for the testing to take place.