HTA Act & Use of Human Tissue

Guidance on the Use of Human Tissue in Research at the
UCL Institute of Ophthalmology

Are you working with human tissue?

  1. If you plan to carry out any research with human tissue your work MUST have received research ethical approval (REC) from an appropriate body before you start.  In most cases, you also need to obtain approval from the Sponsor of the study. For UCL sponsorship, contact the UCL/UCLH Joint Research Office https://www.ucl.ac.uk/joint-research-office. 

    It is the Principal Investigator’s responsibility to ensure that all work performed under their direction has received ethical approval and that they are aware of all those involved in executing the project. It is also each researcher’s responsibility to ensure that the project on which they are working has received ethical approval.
  2. If your work involves storing human tissue in cellular form (i.e. any material consisting of human cells other than gametes and immortal cell lines, in a form where cells are still recognisably present), ethical approval and sponsor approval must be obtained to ensure that your work complies with the Human Tissue Act 2004. The Human Tissue Act 2004 regulates the removal, storage and use of human tissue and details of the legislation can be found at https://www.hta.gov.uk/.
  3. Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research voluntarily with full information about what it means for them to take part, and that they give consent before they enter the research. 
  4. Anyone at the Institute of Ophthalmology working with human tissue in research, whether under a Human Tissue Authority (HTA) licence or a ‘recognised’ REC approval, MUST undertake training on the Human Tissue Act 2024 and its related codes of practice. 

    Human tissue includes anything from a human which contains whole cells including blood and blood products, tissue, cells, urine, sputum, faeces etc., or tissue sections. The HTA regulates all cellular material with the exception of gametes, which are regulated by the UK fertility regulator HFEA. For example, blood is regulated by the HTA and deemed to be ‘relevant material’ however some blood derivatives, such as plasma and serum, provided they are processed appropriately, are not regulated by the HTA as they are considered to be acellular.


Obtaining ethical approval 

Approval for your study may be obtained via two routes:

  1. If human tissue is to be stored within a UCL biobank, or an external biobank licensed by the HTA, you must obtain ethical approval from that Biobank ethics committee. Biobank ethics committees must be approved by the National Research Ethics Service. There are a number of HTA Licenced biobanks at UCL which have National Research Ethics Committee approval. 

    Information about these UCL HTA Licenced biobanks can be found at https://www.ucl.ac.uk/human-tissue/hta-biobanks. The Designated Individual (DI) for each licence can provide details on their Research Tissue Bank approvals and criteria for access. For further details of the IoO licensed biobank (Moorfields Biobank) contact the Moorfields Biobank Manager, Dr Richard Elliott, at r.j.elliott@ucl.ac.uk or  Professor Marcus Fruttiger, the DI, at m.fruttiger@ucl.ac.uk
  2. For research studies which are not covered by HTA licenced biobanks, ethical approval for your project will need to be obtained directly from a Research Ethics Committee authorised by the National Research Ethics Service – see  https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/ 
  3. All ethical approvals are time limited and project restricted. When approval expires an extension to the study must be sought from the relevant ethics committee to extend the study. If an extension is not sought the human samples may be stored in licenced UCL HTA Biobank, or disposed of. Policy on the transfer of human tissue to the governance of IoO HTA licenced Research Tissue Biobank. 

HTA training requirements for working with human tissue

  1. It is vital that researchers are aware of how human tissue research is regulated under the Human Tissue Act 2004. The Principal Investigator is responsible for ensuring that they, all their staff, and any students in their research group are appropriately trained for working with human tissue and that proof of completion is available for auditing purposes.
  2. Human tissue includes anything from a human which contains whole cells including blood and blood products, tissue, cells, urine, sputum, faeces etc., or tissue sections. The HTA regulates all cellular material with the exception of gametes, which are regulated by the UK fertility regulator HFEA. For example, blood is regulated by the HTA and deemed to be ‘relevant material’ however some blood derivatives, such as plasma and serum, provided they are processed appropriately, are not regulated by the HTA as they are considered to be acellular.
  3. Training on Human Tissue Act and its related codes of practice MUST be undertaken by all researchers before they begin working with human tissue and updated every 2 years. The training course is delivered online through the UKRI's MRC Regulatory Support Centre e-learning system at https://bygsystems.net/mrcrsc-lms/course/index.php?categoryid=11.  
  4. Researchers working on human tissue MUST also read the relevant IoO HTA Standard Operating Procedure (SOPs) that can be found below.
  5. Researchers must provide evidence that they have undertaken training in the requirements of the Human Tissue Act and have read the relevant SOPs and complete the Human Tissue Act Training Log. 
  6. This Training Log must be signed off by the Principal Investigator or line manager. In the case of those working under the IoO HTA licence the training log must be signed off by the DI, Prof Marcus Fruttiger or the Person Designated (PD) Dr Dolores Conroy.
  7. There is a requirement to be vaccinated for Hepatitis B 8 weeks before commencing any work using unfixed human tissue samples, including blood, blood products and tissue. Please contact UCL Occupational Health.

HTA License and SOPs

The UCL Institute of Ophthalmology has a HTA license that allows us to store ‘relevant’ human material for use in ethically approved research projects.

SOPs regarding the use of human material under our HTA licence are available below:

Useful documents