Human Tissue Act • City St George's, University of London

Please note this is only applicable for our City, St George's Tooting Campus.

The Human Tissue Act 2004 (HT Act) regulates how human tissue is removed, stored and used. The Human Tissue Authority (HTA) is the regulator that sets the standards for safe and ethical use of human tissue samples, enforces compliance, and issues licences for relevant activities under the act.

At St George’s, University of London, we currently hold the following licences:

Research licence: the licence to store

HTA licensing number 12335

Under this licence we have the right to collect, archive and store human tissue samples (relevant material) for the purposes of carrying out research (scheduled purposes) which are carried out under ethical approval from the Research Ethics Service (RES).

The HTA research licence does not license the research process itself. Collection and storage of human tissues can be made under City St George’s School of Health & Medical Sciences HTA research licence, but research on those holdings cannot commence until ethical approval is obtained from RES.

Human tissue Act Documentation

In order to maintain a complete rolling ‘live audit’ of our tissue holdings, and to optimise the use of tissues and organs which are archived and stored under controlled conditions, City St George’s has implemented the following specific strategy. These steps must be completed by the principal investigator (PI) before commencement of the sample collection.

Documentation process

Step 1: Risk Assessment

Complete a risk assessment (Word document) of the:

equipment storage failure or other damage affecting human tissue quality for useful research
environment failure of security arrangements
processes involved in analysis
receiving and/or storing specimens without appropriate consent documentation
storing or using human tissue after consent withdrawal
loss of human tissue
sample mix-up or loss of traceability
transport of specimens to and from the establishment.

Please send completed risk assessment form (per project) to JRES and Dr Priya Madhou.

Step 2: Training

Train yourself and your staff to understand the requirements for HTA compliance, which are as follows.

Completing the HTA e-learning training module which is available via the Medical Research Council Learning Management System. You will be required to create your own account to gain access to the training. A certificate is generated on completion of the course and assessment.
Completing and updating the good clinical practice (GCP) training offered through JRES.
Ensuring that all staff involved in human tissue attend the HTA workshops run at City St George’s annually, through staff development.
Familiarising yourself and staff with the HTA codes of practice and associated standards.

Useful documents

Step 3: Policy and procedure information

Ensure that all the policies and procedures relating to the collection and storage of human tissues by City St George’s, University of London are understood and implemented by all the members of staff.

See:

Please read Policy for use of Item tracker for further information.

Finally, print out a full set of standard operating procedures for your laboratory.

Standard operating procedures

Step 4: Registration

Ensure that your project/collection is registered and that both JRES and the Human Tissue Act designated individual (DI), Dr Priya Madhou, have a copy of your registration form. Please email one copy to the JRES team along with your RES approval, and one to the DI.

Pease note that host site approval will not be given if the HTA registration document does not accompany the RES approval.

Storing samples after your study

If you wish to store study samples for future research (with consent) under the University's HTA Research Licence, you mus complete the Sample Storage notification form.

This form is submitted directly to the Designated Individual and her team to ensure compliance with the licence.

Frequently Asked Questions

What is relevant material?

See appendix A from the HTA, which is a list of what is considered ‘relevant material’.

Do I need to take consent?

Please refer to the following reference documents:

What do I do if an individual wishes to withdraw their consent?

Ask them to complete a request to withdraw consent form and explain what will happen to their material and any data already collected. Arrange for any specific disposal requests, but if there are none explain the procedures set out at City St George’s.

What should I do in the event of an adverse event or incident?

Firstly, halt the processes or procedures resulting in the adverse event (AE). Secondly, complete an AE/incident form and email it to the Human Tissue Act designated individual (DI), Dr Priya Madhou. The DI will advise further, following an investigation.

What do I need to do to send human material to other research institutes?

Please contact City St George's Joint Research and Enterprise Services (JRES).

If you have other questions, please address them to the Human Tissue Act designated individual (DI), Dr Priya Madhou, or Person Designated (PD) Ash Sameja & Lara Painter

Anatomy licence: the licence to educate

HTA licensing number 12330

City St George's University of London (formerly St George’s, University of London) holds an anatomy licence: the licence to educate (HTA licensing number 12330).

Under this licence we have the right to store whole bodies and body parts for anatomical examination, education or training relating to human health, and research in connection with disorders, or the functioning of the human body. The School of Health & Medical Sciences' Pathology Museum licence is also held under the anatomy licence.

Staff working under HTA licence 12330

Designated individual:

Nicholas Renwick, Lecturer in Anatomincal Sciences

Persons designated:

Ms Georga Longhurst, Head of Anatomical Sciences
Dr Carol Shiels, Reader in Public Engagement, Lead for Public and Civic Engagement, Curator of the Museum of Human Diseases
Dr Nameer Abdulahad, Senior Lecturer in Anatomy, Physiology & Human Tissue
Dr Rehab Eltarhoni, Lecturer in Anatomical Sciences
Mr Andrew Marken, Lecturer in Anatomical Sciences
Dr Priyanka Daniel, Lecturer in Anatomical Sciences
Ms Jessica Antill, Anatomy Teaching Prosector
Ms Victoria Pearce, Lead Demonstrator in Anatomical Sciences
Dr Sherin Roshan, Anatomy Demonstrator
Dr Parth Thakkar, Anatomy Demonstrator
Ms Ana Gordo de Carvalho, Anatomy technician.

Support staff:

Sharon Decardi-Nelson, Anatomy Administrator.

Human Tissue Authority Licensing standards checklist

It is recommended that these standards are applied to all human samples, regardless of whether they are included in the scope of the Human Tissue Act, i.e. relevant and non-relevant material, and samples held with or without Research Ethics Committee (REC) approval.

Please see below for the four HTA Licensing standards:

Consent (C)
Governance and quality systems (GQ)
Traceability (T)
Premises, facilities, and equipment (PFE).

Under each of these headings, there are overarching statements, from which the standards flow. Wherever possible, researchers on our Tooting campus should endeavour to work to these recommended standards.

Checklist for Human Tissue Act Licensing Standards:

Consent standards

C1 Consent is obtained in accordance with the requirements of the Human Tissue Act 2004 (HT Act) and as set out in the HTA’s Codes of Practice

Consent procedures are documented and these, along with any associated documents, comply with the HT Act and the HTA’s Codes of Practice. Examples include:
- Make the intended storage and analysis of DNA clear to donors in the consent form and participant information sheets.
- HRA provides template consent forms and participant information sheets.
Consent forms are available to those using or releasing relevant material for a scheduled purpose. Examples include:
- Keep track of signed consent forms and make sure they are accessible for internal or HTA inspection
- If samples and consent forms arrive separately, regularly check consent forms to ensure consent has been given
- If consent forms are kept by another party and not transferred with the relevant material, the following assurances should be documented between the parties
- Confirmation that appropriate consent is in place, including a copy of the blank consent form and a Material Transfer Agreement (MTA)
- Assurance that consent forms won't be destroyed while City St George's, University of London (CSGUL) holds the relevant material
- Notify City St George 's, University of London (PI’s or Responsible persons) if consent is withdrawn so that relevant material can be disposed of
- Ensure that consent forms (paper or electronic) will be available during an HTA inspection.
Where applicable, there are agreements with other parties to ensure that consent is obtained in accordance with the requirements of the HT Act and the HTA’s Codes of Practice. Examples include:
- External parties should confirm consent through a Material Transfer Agreement (MTA) (refer to the MTA form)
- Documentation where consent forms are kept and how consent is verified.
Written information is provided to those from whom consent is sought, which reflects the requirements of the HT Act and the HTA’s Codes of Practice. Examples include:
- Those writing participant information sheets must be trained in the HT Act requirements.
Language translations are available when appropriate. Examples include:
- Translation into other languages should be available if requested.
Information is available in formats appropriate to the situation. Examples include:
- Where appropriate, use visual, audible, or novel means of providing information during the consent process where this may enhance participant understanding.

C2 Staff involved in seeking consent receive training and support in the essential requirements of taking consent.

There is suitable training and support of staff involved in seeking consent, which addresses the requirements of the HT Act and the HTA’s Codes of Practice. Examples include:
- Individuals obtaining consent for the use and storage of relevant material for research should seek Good Clinical Practice, HTA and informed consent training.
Records demonstrate up-to-date staff training. Examples include:
- Documentation of informed consent and HTA training, ideally in a dedicated HTA file and in staff personal development records.
- Maintain training records for staff, including completed training, competencies, and records of reading SOPs and risk assessments
- Update training when there are changes in legislation, new policies, different research activities, or a significant amount of time has passed since research activities were last conducted.
Competency is assessed and maintained. Examples include:
- Conduct formal competency assessments based on the consent SOP to prove competence.
- Consent-seekers should stay informed about current standards by referring to published guidance and relevant policies.

Governance and quality system standards

GQ1 All aspects of the establishments work are governed by documented policies and procedures as part of the overall governance process.

1). Ratified, documented and up-to-date policies and procedures are in place, covering all licensable activities. Examples include:

Overarching HTA SOPs, see Human Tissue Documentation
Local SOPs as required.

Guidance

At a minimum, it is expected that most establishments will have standard operating procedures (SOPs) covering the following activities:

consent
collection
receipt
labelling
specimen preperation / preservation
storage
relevant transport arrangements
cleaning and decontaminsation
disposal.

A standard operating procedure (SOP) should be a clear and accurate representation of an existing procedure or process, preferably set out in the format of a stepwise guide. SOPs should be understandable to enable new staff to follow a procedure from beginning to end. They should be detailed enough to ensure uniformity between staff in the performance of a specific function and should be followed to the letter by all staff who have been appropriately trained.

People undertaking the processes should be involved in developing the SOPs to ensure that the written procedures reflect actual practices. Regular review of SOPs will help to prevent incremental departure from written processes with passing time and allow establishments to identify improvements. Establishments should introduce a system to record that staff have read and understood SOPs.

If human tissue is to be transferred between establishments, consideration must be given to minimise the likelihood of theft, damage or loss during transport. Some form of formal transfer arrangement, for example, as part of a Material Transfer Agreement (MTA) should define how the human tissue is preserved, any potential contamination risks associated with it; and who is responsible for disposal, if applicable.

2). There is a document control system. Examples include:

Local SOPs and policies need approval and follow document management guidelines outlined in CSGUL_SOP_GEN 1
Keep a document control database that lists all documents with review dates
Have systems in place to confirm document access (like self-inspection)
Maintain an audit trail to track changes in electronic records, including who made the changes and the date
Distribute new document versions and archive old ones.

Guidance

Governance documents should include:

revision history and version number
'effective from' date
review date (at least every three years)
pagination
author and reviewer names.

3). There are change control mechanisms for the implementation of new operational procedures. Examples include:

If there are suggested changes to the overarching HTA SOPs, they must go through a formal process, coordinated and controlled by the SGUL Human Tissue Licence Review Group.
For both overarching HTA SOPs and local SOPs, the change control system should assess the risks, validate new techniques and procedures before implementation, and monitor the impact of multiple minor changes over time.

4). Matters relating to HTA-licensed activities are discussed at regular governance meetings, involving establishment staff. Examples include:

The Human Tissue Licence Review Group meets every quarter. Any issues should be reported to the HTA designated individuals (DI), Dr. Priya Madhou.

5). There is a system for managing complaints. Examples include:

Complaints should be made according to CSGUL_SOP_R11
Inform the DP / DI of the complaint and provide a written record.

GQ2 There is a documented system of audit

1). There is a documented schedule of audits covering licensable activities. Examples include:

The DI and PD will regularly audit collections of relevant and non-relevant material. These audits will be documented and followed up with a report, and if necessary, a Corrective and Preventative Action (CAPA) plan.
Custodians of sample collections should conduct self-inspection traceability audits regularly and maintain records, such as an Excel sheet with dates, sample IDs, and findings, tracking from consent forms to sample storage locations and vice versa.

2). Audit findings include who is responsible for follow-up actions and the timeframes for completion. Examples include:

Audit findings will be documented and if required, a Corrective and Preventative Action (CAPA) plan will be sent to the investigator with a deadline for completion.

GQ3 Staff are appropriately qualified and trained in techniques relevant to their work and are continuously updating their skills

1). Qualifications of staff and all training are recorded, records showing attendance at training. Examples include:

Staff must know the HTA Codes of Practice and related standards
Each person should maintain their own training record with current information, training certificates, CV, and job descriptions if applicable
Keep a record of reading and understanding quality documents
Staff handling human tissue should attend the annual HTA workshops at CSGUL, booked through staff development at staffdev@sgul.ac.uk. All staff working under a HTA licence should complete the HTA e-learning training module available via the Medical Research Council Learning Management System
Good clinical practice (GCP) training is available through JRES
Equipment manuals or Laboratory equipment specific SOPs should be available to all staff and reading of these documented.

2). There are documented induction training programmes for new staff. Examples include:

Attendance documented and records available for inspection.

3). Training provisions include those for visiting staff. Examples include:

Records should be maintained of training provided to visiting staff.

4). Staff have appraisals and personal development plans. Examples include:

Records of staff appraisal or personal development review are available for inspection as part of the internal audit process.

GQ4 There is a systematic and planned approach to the management of records

1). There are suitable systems for the creation, review, amendment, retention and destruction of records. Examples include:

All sample collection documents should be identified with the document title, author, approver, date issued, version number and for paper-based systems, a copy number.
Superseded versions of documents should be archived, and copies removed from circulation.
A description of changes made should be included in revisions.
Regular self-inspections of consent forms, equipment maintenance logs, service records, training records etc.

2). There are provisions for back-up / recovery in the event of loss of records. Examples include:

Documented back up/recovery systems should be in place to cover electronic and paper records.

3). Systems ensure data protection, confidentiality and public disclosure (whistle-blowing). Examples include:

Evidence that staff have attended City St George’s mandatory Data Protection training course.

GQ5 There are systems to ensure that all adverse events are investigated promptly

1). Staff are instructed in how to use incident reporting systems. Examples include:

Evidence of training documented.
The Adverse Effects (AE)/incident form can be found here. This should be emailed to the HT Act DI who will advise further, following an investigation.

3). Effective corrective and preventive actions (CAPA) are taken where necessary and improvements in practice are made. Examples include:

These should be documented in the CAPA form supplied by the DI. Note: examples of AE include specimen loss; missing or incorrect documentation; security breach; abnormalities in storage temperature readings; inappropriate disposal.

Relevant examples of adverse events include:

specimen loss
missing or incorrect documentation
security breach
abnormalities in storage temperature readings
inappropriate disposal.

GQ6 Risk assessments of the establishment’s practices and processes are completed regularly, recorded and monitored

1). There are documented risk assessments for all practices and processes requiring compliance with the HT Act and the HTA’s Codes of Practice. Examples include:

Investigators should complete a risk assessment from procurement to disposal and send this to JRES and the Designated Individual DI. pmadhou@citystgeorges.ac.uk.

Risk assessments should include the risks relating to the premises, practices and procedures connected with licensed activities, including:

receiving and/or storing specimens without appropriate consent documentation
storing or using human tissue after consent withdrawal
storage failure or other damage affecting human tissue quality for useful research
loss of human tissue
sample mix-up or loss of traceability
transport of specimens to and from the establishment
security arrangements
incorrect disposal.

3). Risk assessments are reviewed regularly. Examples include:

Risk assessments should be reviewed periodically (typically, every 1-3 years) and the actions to mitigate risks updated as necessary
Risk assessments should also be reviewed following an incident
Processes in place to ensure participant’s wishes are checked before forwarding their material, and notification given to receiving organisation of their wishes if required
The audit trail contains details of consent and location of signed consent form, full details of where samples were received from and sent to
A Material transfer Agreement is in place when material is being transferred to or received from other organisations
Risk assessment of transportation method should include verification of maintenance of cold conditions where necessary by use of data loggers, with data retained on file.

Guidance

Risk assessments should be reviewed periodically (typically, every 1-3 years) and the actions to mitigate risks updated as necessary.

Risk assessments should also be reviewed following an incident.

3). Staff can access risk assessments and are made aware of risks during training.

Traceability

T1 A coding and records system facilitates the traceability of bodies and human tissue, ensuring a robust audit trail

1). There is an identification system which assigns a unique code to each donation and to each of the products associated with it. Examples include:

Each sample and derivative should have a local SOP explaining how they will be labelled uniquely.

2). A register of donated material, and the associated products where relevant, is maintained. Examples include:

Can be in the form of an excel sheet or via CSGUL ItemTracker.

3). An audit trail is maintained, which includes details of: when and where the bodies or tissue were acquired and received, the consent obtained, all sample storage locations; the uses to which any material was put, when and where the material was transferred, and to whom. Examples include:

Include dates and reasons for disposal, partial disposal, or use of sample.

4). A system is in place to ensure that traceability of relevant material is maintained during transport. Examples include:

Local SOPs should be developed where relevant material is transported
SOPs should detail the local arrangements for traceability of samples throughout the transfer process
Specialist couriers should be used wherever possible
Service Level agreement in place with courier companies
Relevant material must be subject to a chain of custody process.

5). Records of transportation and delivery are kept. Examples include:

Records should detail individual samples of relevant material
Transportation documents retained.

6). Records of any agreements with courier or transport companies are kept. Examples include:

Agreements should be reviewed regularly
Copies should be retained in HTA files.

7). Records of any agreements with recipients of relevant material are kept. Examples include:

Responsibilities of provider and recipient parties should be set out in a MTA or as part of a service level agreement.
Agreements must be go through the JRES for signing.
Agreements stored centrally and accessible for internal audit/HTA inspection.
Copies of signed MTA should be retained in the researcher’s HTA site files.

T2 Bodies and human tissue are disposed of in an appropriate manner

1). Disposal is carried out in accordance with the HTA’s Codes of Practice.

2). The date, reason for disposal and the method used are documented. Examples include:

This can be recorded in an excel sheet or in CSGUL Item Tracker.

Premises, facilities and equipment standards

PFE1 The premises are secure and fit for purpose

1). An assessment of the premises has been carried out to ensure that they are appropriate for the purpose. Examples include:

Risk assessments should be performed to cover all aspects of storage and use of relevant material.
Risk assessments should be reviewed at defined intervals (every 1-3 years) or when changes to the premises may affect the risks.

2). Arrangements are in place to ensure that the premises are secure and confidentiality is maintained. Examples include:

Fridges/freezers/cabinets are locked when in areas accessible to general laboratory personnel.

3). There are documented cleaning and decontamination procedures. Examples include:

Cleaning and decontamination of premises should be scheduled and recorded.
Responsibility for performing cleaning and decontamination should be assigned to suitable individuals.

Documented cleaning and decontamination procedures should be supported by schedules.

PFE2 There are appropriate facilities for the storage of bodies and human tissue

1). There is sufficient storage capacity. Examples include:

Tissue held under a HTA licence is stored separately.
Storage units containing relevant material held under the licence should display the HTA licence certificate.

2). Where relevant, storage arrangements ensure the dignity of the deceased.

3). Storage conditions are monitored, recorded and acted on when required. Examples include:

-80°C storage conditions are monitored by the Haier Freezer Web based monitoring system that alarms in the event of temperature excursions.
It is recommended that signs should be attached to freezers defining alarm set points.

Guidance

Documented temperature monitoring allows establishments to easily visualise and identify when temperatures are out-of-range. It can also demonstrate temperature trends, to identify when storage conditions may be deteriorating and to alert staff to developing equipment failure.

Temperature alarms should be regularly tested and manually challenged periodically to ensure that they are operating as expected.

Signs should be added to freezers to define alarm set points for the temperature ranges so that staff are visually reminded of minimum and maximum temperatures.

Where storage is critical, an appropriate remote temperature monitoring alarm and callout system may be required.
Checks and filling of liquid nitrogen dewars should be documented.

Where material can be stored at ambient/room temperature, this does not mean that storage conditions do not need to be monitored.

4). There are documented contingency plans in place in case of failure in storage area. Examples include:

Freezers should have labels indicating the location of contingency storage areas.

Guidance

The establishment must have contingency arrangements in place should there be an emergency situation that renders the premises unusable for the storage of human tissue, this may need to be through a formalised arrangement with another HTA-licensed establishment for transfer of material.

General guidance

Areas used for storage of human tissue for use in research must provide an environment that is safe for those working under the licence and preserves the integrity of the tissue.

Refrigerators, freezers and other vessels which contain human tissue should be appropriately labelled so that staff are aware of the necessity to maintain the quality, safety and security of such material and prevent mix-ups with other tissues.

PFE3 Equipment is appropriate for use, maintained, validated and where appropriate monitored

1). Equipment is subject to recommended calibration, validation, maintenance, monitoring, and records are kept. Examples include:

Individuals obtaining consent for the use and storage of relevant material for research should seek Good Clinical Practice, HTA and informed consent training.

2). Records demonstrate up-to-date staff training. Examples include:

Documentation of informed consent and HTA training, ideally in a dedicated HTA file and in staff personal development records.
Maintain training records for staff, including completed training, competencies, and records of reading SOPs and risk assessments
Update training when there are changes in legislation, new policies, different research activities, or a significant amount of time has passed since research activities were last conducted.

3). Competency is assessed and maintained. Examples include:

Conduct formal competency assessments based on the consent SOP to prove competence.
Consent-seekers should stay informed about current standards by referring to published guidance and relevant policies.

Download and print the checklist.