The aim of this information is to provide guidance on the use of human biological samples for research purposes.
1. Do I need a licence from the Human Tissue Authority (HTA) to store tissue for research purposes?
Yes.
A licence is required to store tissue (or any ‘relevant material’) for research unless it is for a research study with current project-specific ethics approval. Ethics approval must have been granted by a recognised Research Ethics Committee. These are:
- an NHS (or Health and Social Care in Northern Ireland) Research Ethics Committee (REC).
- 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.
Use this HTA licence requirements flowchart to determine if your research requires a licence.
2. I have ethics approval for a current study. Can I keep any samples I collect for future studies?
Yes.
Tissues can be stored for future research if the terms of donor consent allow. A licence is required for storage unless application for ethics approval for further research is pending. The Human Tissue Act 2004 uses the term ‘relevant material’. In the Act, “relevant material” means material, other than gametes, which consists of or includes human cells. e.g. organs, tissues, blood. This does not include:
- embryos outside the human body, or
- hair and nail from the body of a living person.
Guidance on ‘relevant material‘ and a list of materials and their classification can be on the HTA website.
3. Are blood samples 'relevant material'?
Yes.
Whole blood contains cells so is relevant material. However, if it is processed optimally to plasma or serum (i.e. rendered acellular) it is no longer relevant and does not require a licence.
4. Does MFT have a licence?
Yes.
Manchester University NHS Foundation Trust (MFT) has a licence for:
Storage of relevant material which has come from a human body for a scheduled purpose.
The scheduled purpose is ‘Research in connection with disorders or functioning of the human body’. Licence number 12552. This is usually referred to as the Trust HTA Research Licence.
5. Which buildings are covered by the licence?
Manchester Royal Eye Hospital, Saint Mary’s Hospital, Royal Manchester Children’s Hospital, Manchester Royal Infirmary and the NIHR Manchester Clinical Research Facility (CRF) are covered by the licence. University buildings (e.g. Stopford Building, Core Technology Facility, A.V. Hill Building, Michael Smith Building) are not covered by the Trust licence. The University has a separate licence. University laboratories on the MFT site (e.g. St Mary’s research floors) are covered by the Trust licence.
6. If I store my samples on the MFT site, am I automatically covered by the Trust licence?
No.
Only samples which have been declared to the licence Designated Individual (Prof Nalin Thakker) are deemed to be ‘licensed’. Any laboratory must meet the standards required for compliance with the terms of the licence before being allowed to store samples. This includes producing a HTA Master File of documentation and records. Traceability of all samples must be recorded on the Trust Itemtracker database. Any researchers wishing to store samples under the HTA licence must contact the Designated Individual or HTA Licence Manager at least 6 months in advance in order for their suitability and compliance to be assessed. This also applies to samples being retained at the end of an ethically approved study.
7. What is ItemTracker?
Itemtracker is a software database for tracking ‘relevant material’ stored at MFT. It is free and available to all researchers storing human samples. Contact the HTA Licence Manager (
Dr Jay Brown) to arrange installation and training.
8. Is there any training available on these issues within the Trust?
Yes.
Human Tissue Act in research training sessions are run by the DI and Licence Manager The course covers the Human Tissue Act 2004 and how it applies to the research sector. It includes information on the Human Tissue Authority and licensing requirements for storage of human tissue samples. Who should attend? All staff involved with the collection, storage or use of human tissue samples for research on the MFT site.
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10th March 2020 14.00 – 15.30, Education South, Seminar Room 1
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17th June 2020 12.00 – 13.30, Education South, Seminar Room 1
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2nd October 2020 12.00 – 13.30, Education South, Seminar Room 1
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9th December 2020 11.00 – 12.30, Education South, Seminar Room 1
Please download and complete the HTA training booking form 2020 and return to Dr Jay Brown by email: jay.brown@mft.nhs.uk. Places are limited so bookings must be confirmed in advance. Attendance is compulsory for staff storing samples under authority of the HTA research licence.
9. Does the Trust have policy documents and SOPs on the use of tissues for research? What other guidance is available?
Yes.
The Trust has several policy documents and Standard Operating Procedures that all staff using human tissues in research must follow (see table). In addition the HTA issues statutory Codes of Practice. These codes of practice provide guidance and lay down expected standards for each of the regulated sectors. The codes are designed to support professionals by giving advice and guidance based on real-life experience. Codes of Practice can be downloaded from the HTA website. Code of Practice 9 Research is aimed specifically at the research sector and is essential reading for anyone using human tissues in research.
Policies
Standard Operating Procedures
Guidance documents
Forms
10. What is the Human Tissue Act 2004?
The purpose of the Act is to provide a consistent legislative framework for issues relating to whole body donation and the taking, storage and use of human organs and tissue. It will make consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts, organs and tissue and the removal of material from the bodies of deceased persons. It will set up an over-arching authority which is intended to rationalise existing regulation of activities like transplantation and anatomical examination, and will introduce regulation of other activities like post mortem examinations, and the storage of human material for education, training and research. It is intended to achieve a balance between the rights and expectations of individuals and families, and broader considerations, such as the importance of research, education, training, pathology and public health surveillance to the population as a whole. Further information is available on the
UK legislation website.
11. What is the Human Tissue Authority?
The HTA was established on 1 April 2005 under the Human Tissue Act 2004 (HT Act) which extends to England, Wales and Northern Ireland. The HTA is an Executive Non-Departmental Public Body (ENDPB) sponsored by the Department of Health. The HTA’s aim is to create a regulatory system for the removal, use and disposal of human tissue and organs that is clear, consistent and proportionate and in which professionals, patients, families and members of the public have confidence. The HTA licenses a number of activities relating to human tissue. They are also responsible for carrying out inspections to ensure licence conditions are being met. These activities are laid out in the Human Tissue Act and associated Regulations. Further information is available on the
HTA website. The activities licensed by the HTA are:
- Carrying out of an anatomical examination
- Making of a post-mortem examination
- Removal of relevant material from a deceased person
- Storage of relevant material from a deceased person (other than for a specific ethically approved project)
- Storage of anatomical specimens
- Storage of relevant material from a living person for research (other than for a specific ethically approved project) or for human application
- Public display of a body or material from a deceased person
If you have any further questions please contact:
