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.
Standard Operating Procedures
Human Tissue Standard Operating Procedures
Standard Operating Procedures (SOPs), associated forms and guidelines for research involving human tissue.
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
Northern Ireland Molecular Pathology Laboratory
David Keir Building
RVH Research Licence 12059 (DI Dr Ann McGinty)
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 is material that has come from a human body and consists of, or includes, human cells. Examples include:
- Tissue Samples
The definition of relevant material and a supplemenatry 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.
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.
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.
- Quality Manual (pdf)
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:
- Regulations for Research Involving Human Participants (pdf)
- Policy and Principles on the Ethical Approval of Research (pdf)
- Regulations Governing the Allegation and Investigation of Misconduct in Research (pdf)
Attendance at a Human Tissue Act seminar is mandatory for all (this includes students who work with relevant material) and refresher training will be required every three years. An attendance register is maintained and certificates are issued to all those who have attended. Human Tissue Act training is provided by Research Governance and a minimum of 10 sessions during term-time are scheduled per year.
Please contact Research Governance at firstname.lastname@example.org to register and confirm the seminar date you wish to attend.
Research Governance also arranges courses related to informed consent and coordinates access to the Good Clinical Practice (GCP) e-Learning tool which contains a module on the informed consent process. Please contact Research Governance for details.