Human tissue authority
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?
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?
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.
3. Are blood samples 'relevant material'?
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?
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?
6. If I store my samples on the MFT site, am I automatically covered by the Trust licence?
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?
8. Is there any training available on these issues within the Trust?
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.
5th March 2018 14.00 – 15.30. Education South, Seminar Room 1
19th June 2018 11.00 – 12.30. Education South, Seminar Room 1
3rd October 2018 11.00 – 12.30. Education South, Seminar Room 1
12th December 2018 11.00 – 12.30. Education South, Seminar Room 1
Please download and complete the HTA training booking form 2018 and return to Dr Jay Brown by email: firstname.lastname@example.org. 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?
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.
Standard Operating Procedures
- Disposal of Human Tissue Samples (Research) -HTA005
- Transfer of Human Tissue Samples (Research) – HTA006
- Human Tissue Act Document Control (Research) – HTA007
- Management of Records (Research) – HTA008
- Human Tissue Samples (Research) – HTA009
- Coding/Tracking of Human Tissue Samples (Research) – HTA011
- HTA Adverse Event and Incident Reporting (Research) – HTA012
- Audit of Licenced Tissue Holdings (Research) – HTA013
- Consent Recording (Research) – HTA014
- Use of ItemTracker sample management and tracking software – HTA015
- Use of human tissue in research FAQ – HTA016
10. What is the Human Tissue Act 2004?
11. What is the Human Tissue Authority?
- 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