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Background

The use of human tissue for research purposes is governed by the Human Tissue Act 2004 and any subsequent amendments. This legislation regulates the removal, storage and use of human tissue defined as 'relevant material' that has come from a human body and consists of, or includes, human cells. The Human Tissue Authority (HTA) is the regulatory body which licences establishments storing and using relevant material for 'scheduled purposes' such as research or anatomical examination. The HTA has issued Codes of Practice which detail the standards expected from licenced establishments.

Genomics 800

Standard Operating Procedures

Human Tissue Standard Operating Procedures

Standard Operating Procedures (SOPs), associated forms and guidelines for research involving human tissue.

Human tissue standard operating procedures

Licencing

The University holds two research licences and one anatomy licence. The licences cover the following areas:

MBC/BCH Research Licence 12044 (DI Dr Jackie James)

Centre for Cancer Research and Cell Biology
Centre for Infection and Immunity
School of Pharmacy
David Keir Building
School of Biological Sciences

RVH Research Licence 12059 (DI Dr Gareth McKay)

Centre for Public Health
Centre for Experimental Medicine

Anatomy Licence 12113 (DI Ms Samantha Taylor)

Anatomy licenced area, Centre for Biomedical Sciences Education
An overview of the licencing structure is available here.

Information for the anatomy licenced area and body bequests can be found here.

Relevant Material

Relevant material is material that has come from a human body and consists of, or includes, human cells. Examples include:

  • Blood
  • Urine
  • Faeces
  • Tissue Samples
  • Saliva
  • Sputum
  • Skin
  • Bone

The definition of relevant material and a supplementry list of materials can be found on the Human Tissue Authority’s website. Nails and hair from the living are not considered as relevant material and gametes are also excluded. Where relevant material is processed, treated or lysed, and as a result of the process or treatment is rendered acellular, then the material may be regarded as such. This includes cells divided and created outside the human body or the freezing and thawing of cells only where that process is intended to render the material acellular.

Consent

Informed consent is the fundamental principle behind the Human Tissue Act and must be in place for the removal, storage and use of relevant material for research purposes. The individual obtaining consent must have received suitable training as required by the Human Tissue Authority. The Standard Operating Procedure (SOP) Informed Consent for Research describes the processes involved when seeking informed consent for research. The Human Tissue Authority’s Code of Practice 1: Consent details the expected standards for consent under the Human Tissue Act.

In addition, the University requires that when material is used for research purposes it has the appropriate ethical consideration.

Quality Manual

In order to ensure compliance with licensing requirements the University has developed regulations, policies and SOPs. An overview of these and the management of Human Tissue Act related activities are provided in this Quality Manual.

Regulations and Policies

The University has established regulations and policies to govern research and maintain the integrity of research carried out under its auspices. The University’s Human Tissue Act-related regulations and policies are:

Training

While the University complies with the Government’s requirements to minimize the spread of COVID-19, online training on the Human Tissue Act can be undertaken using the MRCs Research and Human Tissue Legislation e-learning module.  However, it is important to note that there are differences between this online training and the University’s requirements, which are covered when the Research Governance Team deliver their face-to-face training.   

The MRC’s online training goes into some detail on licensing exemptions e.g. NHS/HSC REC approval, processing within 7 days etc., whereas the University treats all samples, irrespective of the REC that has approved the research, as falling within its licenses.  Further information can be found in the University’s Standard Operating Procedures available here: https://www.qub.ac.uk/Research/Governance-ethics-and-integrity/Human-tissue/ 

Please note that you will also be required to complete the appropriate quiz (England, Wales and NI). On completion of the quiz the certificate should be sent as a screen print or screen snip to researchgovernance@qub.ac.uk   

Access to the Queen’s Online Human Tissue Database can be requested once you have completed the training by emailing researchgovernance@qub.ac.uk.  Once access is granted you will be directed to the database and how to download a user guide.  

MRC Research and human tissue legislation online training and Research and human tissue legislation assessment - England, Wales & NI are available here: 

https://byglearning.co.uk/mrcrsc-lms/course/index.php?categoryid=1 

You will need to register for an account MRC Regulatory Support Centre Learning Management System in order to access the training. 

If you are unsure of any element of the training, or if you have any further HTA related queries, please get in touch with researchgovernance@qub.ac.uk