Human Tissue Act
The Human Tissue Act 2004 came into force on the 01 September 2006 and replaces several other acts of parliament. The Act applies to England, Wales and Northern Ireland and makes it unlawful to store or use human tissue from the living and the dead for scheduled purposes without consent. The Act was introduced following parliamentary review of the legislation and regulatory framework regarding the removal, use, and storage of human tissue. This review was informed by the findings of a number of inquiries and investigations into the unauthorised removal and retention of human organs at a number of institutions. Non-compliance with the Act can result in fines or up to 3 years imprisonment, or both.
Informed consent is the fundamental principle on which the Human Tissue Act 2004 is based. Consent is required for the storage and use of human tissue for a schedule purpose under the Act, such as research in connection with disorders, or the functioning, of the human body.
Human Tissue Authority (HTA)
The HTA became effective on 01 April 2005, and was set up to regulate activities under the Human Tissue Act 2004 and to restore public confidence in the use of human tissue. The HTA issues licences for relevant activities under the Act and has the power to review, suspend, and revoke licences. The HTA also has the power of entry, inspection, search, and seizure. The HTA has produced seven codes of practice in order to provide guidance and lay down expected standards for those working with human tissue in England. These codes of practice came into force in April 2017.
Edge Hill University and Human Tissue
Edge Hill University undertakes ethically approved research involving human tissue. The University also has a research licence issued by the Human Tissue Authority (licensing number 12632) to lawfully store human tissue on the premises. The University views all human tissue as a valuable resource and is grateful to those who have donated tissue samples. Tissue samples should only be used in accordance with the wishes of the donor. The University expects all its staff and students using human tissue to adhere to the Human Tissue Authority’s guiding principles, as laid out in its Code of Practice A: Guiding Principles and the Fundamental Principle of Consent. These guiding principles are:
- Consent: The wishes of the donor have primacy when removing, storing and using human tissue
- Dignity should be paramount in the treatment of human tissue
- Quality should underpin the management of human tissue
- Honesty and openness should be the foundation of communications in matters pertaining to the use of human tissue. As part of its commitment to these guiding principles Edge Hill University publishes Human Tissue Authority inspection reports on its webpages and ensures the inclusion of lay persons on the ethics committee that reviews and approves all research involving human tissue within the University.
If you have any enquiries or concerns regarding Edge Hill University’s activities involving human tissue, please write to:
Research Office (FAO: Phil Bentley, URESC Secretary), The Business School, Edge Hill University, Ormskirk, L39 4QP
Working with human tissue at EHU
Any staff or students planning to use or store human tissue should contact the University’s Designated Individual (Prof Adrian Midgley; Email: [email protected]; Tel: 01695 584318/ext. 4318). The Designated Individual is the person who has legal responsibility for the University’s compliance with human tissue legislation and Human Tissue Authority licensing standards.
A supplemental guidance note has been prepared for Heads of Department and URESC members to highlight some of the information contained in the Human Tissue Quality Manual. Policies and procedures addressed in this document are those of consent, storage, records and audit, transport, import and export, and reporting adverse events.
Human Tissue Management Sub-Committee (HTMSC)
The HTMSC at Edge Hill University is responsible for overseeing and supporting research involving human tissue and reports directly to the University Research Committee.
One of its main roles is to produce the Human Tissue Quality Manual – the policies and procedures governing the acquisition, use, storage, and disposal of human tissue at Edge Hill University. All staff and students undertaking research involving human tissue must adhere to these policies and procedures.
The University’s other research governance documents also must be adhered to. Other documents relating specifically to human tissue can be accessed directly by staff in the ‘HTA Compliance Documents’ folder located on the University’s shared ‘Y drive’; students should contact the Designated Individual to obtain the documents.
HTMSC Terms of Reference
- To establish, review, and revise policies and procedures to ensure Edge Hill University conducts its business in accordance with the requirements of the Human Tissue Act(2004) and associated codes of practice.
- To monitor activity under the University’s Human Tissue Research Licence.
- To monitor compliance with the conditions of the University’s Human Tissue Research Licence, and policies and procedures detailed in the University’s Human Tissue Quality Manual, including the review of internal and Human Tissue Authority audits.
- To establish the provision and monitoring of training and support given to Edge Hill University staff and students working under the University’s Human Tissue Research Licence, as well as members of the University Research Ethics Sub-Committee.
- To review any adverse events relating to the handling or storage of human tissue and implementing changes in policy or procedure where appropriate.
- To receive reports from the University Research Ethics Sub-Committee on ethics applications received that contain licensable activity.
- To monitor the effectiveness of the Committee on an annual basis.
- To ensure that equality considerations are taken into account in the conduct of the committee’s business.
Ethical Approval of Research involving Human Tissue
Any staff or students intending to conduct research using or storing human tissue should first contact the University’s Designated Individual for advice. All ethics applications for research involving the use or storage of human tissue must be reviewed and approved by the Science Research Ethics Committee . The completed ethics application should be submitted via Haplo.
Human Tissue Training
Any staff or students conducting research using or storing human tissue must undertake training on human tissue legislation and Edge Hill University’s policies and procedures for the acquisition, use, storage, and disposal of human tissue. Those staff and students seeking consent from research participants for the use or storage of human tissue for research, also must be assessed on their competency in seeking consent. Records of such training and competency assessment must be maintained for internal audits and inspection by the Human Tissue Authority. Please speak to the University’s Designated Individual to discuss and arrange training and assessment of competency in seeking consent.
HTA inspection reports
This page contains inspection reports of Edge Hill University by the Human Tissue Authority.