Human Tissue Act

Research Involving Human Tissue

The use of human tissue in research is highly regulated to protect tissue donors, their families and researchers.

Human Tissue Act (2006)

The Human Tissue Act (HT Act) covers England, Wales and Northern Ireland and came into full effect on September 1^st 2006 to act as a legal framework for the regulation of the removal, storage, use and disposal of human bodies, organs and tissues.

The HT Act was created and implemented in response to public inquiries into events at the Bristol Royal Infirmary and Alder Hey Children’s Hospital which revealed that researchers had removed and stored patient tissue and organs without consent. The Act now enshrines consent for the removal, use and storage of tissue and organs in law.

The HTAct and Human Tissue Authority (HTA) govern the use of human tissue considered 'Relevant Material'.

Relevant Material

Relevant material as defined by the HTAct is material derived from a human body which consists of or includes cells

(including bodily waste products).

Human tissue that falls under the legislation is referred to as ‘Relevant Material’ and covers any human sample that may contain even a single cell including blood, urine, skin, sputum, fixed tissue, tears and waste fluids. Researchers should refer to the published HTA list of relevant material for a comprehensive guide to the types of human material covered by the HT Act.

Researchers should visit the HTA's website to review their list of tissues considered Relevant Material.

Or seek advice from the Human Tissue Governance Officer if you are unsure.

The following are excluded from the act:

Gametes
Hair and nails from the body of a living person
Embryos created outside the human body
Cell lines
Extracted cellular components
Acellular material

Human Tissue Authority

The Human Tissue Authority (HTA), an executive agency of the Department of Health, was established by the Act in 2005 to regulate the removal, storage, use and disposal of human bodies, organs and tissues from the living or deceased for certain purposes including research, transplantation and public display. Relevant Material can only be legally stored for research either under the governance of NHS Research Ethics Committee (REC) study approval or a HTA Research Sector licence.

All specific research projects which involve the prospective collection, use and storage of tissue samples from NHS patients or healthy volunteers must gain the appropriate NHS REC approval.

Relevant Material which is stored for future use (e.g. retained at the end of a specific study or in a bio-bank) must be stored under a HTA licence. Access to Relevant Material stored under a licence must be restricted and storage is overseen by the Designated Individual. This also applies to any other associated clinical data, which must be stored in accordance with GDPR with full consideration of donor confidentiality.

Staff and Students should visit the the HTA website and familiarise themself with the Codes of Practice:

Code A: Guiding principles and the fundamental principle of consent, is the overarching Code and contains information that is applicable to all establishments and professionals operating under our governing legislation.
Code E: Research Sector
Research Licensing Standards and Guidance

Ethical Approval Pathways

Principal Investigators who plan to use or store human tissue for a research study must submit an ethical application using Swansea University's Ethics portal:

Ethics: Applicant, and Healthcare Sponsorship

SU internal ethical approval is not sufficient for projects involving the storage of tissue considered 'Relevant Material' and the researcher must notify the Human Tissue Governance Officer (HTGO) MUST by email to HumanTissueResearch@Swansea.ac.uk, in addition to SU ethical application.

Refer to the Swansea University Research Ethics for full details.

Submit a 'Research Ethical Application Form' to be reviewed internally by the appropriate University Ethics Committee, if your research involves:

New collection of tissue from health donors
Acceptance of human tissue from a collaborator(s)
Commercial supply of human tissue

Submit a 'Healthcare Research Sponsorship' form to be reviewed by the Swansea University Sponsorship Committee if your research involves NHS patients or their samples. This application must be done in conjunction with your IRAS application for NHS REC approval.

No human tissue collection should commence before submission and approval is received.

Quality Management System

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HTA Core SOPs

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HTA Forms & Templates

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Training Links

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Human Tissue Authority Research Licence

A HTA licence allows establishments to legally store human tissue for the scheduled purpose of research. This may be storage for current or future unspecified research. Scheduled purposes are defined as those which legally require consent under the HT Act.

HTA licences are overseen by a Designated Individual (DI) who has been approved by the HTA to act in this capacity. The DI has oversight of the storage of all Relevant Material held under the licence.

The HTA does not regulate or approve the use of the tissue for research; therefore any specific research studies involving human material stored under a licence must be subject to NHS Research Ethics Committee (REC) review. The HT Act legally requires consent be obtained for a number of ‘scheduled purposes’ of which one is the storage of relevant material for research.

A HTA research sector licence is required in the following circumstances:

To continue to store relevant material following the expiry of NHS REC approval
To store relevant material from healthy volunteers without NHS REC approval (studies must also be approved by University Ethics Committee)
To store imported or commercially sourced relevant materialfor use in a non-NHS REC approved research study
To store human tissue for bio-banking purposes, even where generic bio-bank REC approval has been granted to cover a programme of research

Notification of Intention to Store Relevant Material

The Designated Individual is required by the Human Tissue Authority to maintain an overview of all human tissue use within the institutions for which they are responsible, including tissue stored under NHS REC approval.

The HTA has declared an intention to note REC-approved studies during inspections to inform areas for future inspection to ensure that tissue is not stored outside REC approval unless under a licence.

A notification will be sent to the Human Tissue Governance Officer and DI of your intended research activities when you submit Ethics: Applicant, and Healthcare Sponsorship

However, SU internal ethical approval is not sufficient for projects involving the storage of tissue considered 'Relevant Material' for any period of time.

In addition, to SU ethical application the Human Tissue Governance Officer (HTGO) MUST be notified by email to HumanTissueResearch@Swansea.ac.uk in the following circumstances:

Where human tissue, considered 'Relevant Material', will be stored at Swansea University.
Where human tissue is being imported or exported outside of the UK for any research study.

In this case, the Principal Investigators must complete and submit the HTA-FORM-Importation Justification and await authorisation.

No human tissue may enter the university outside England, Wales or Northern Ireland before agreed by the HTGO and DI.
Where tissue is purchased from commercial sources; commercial tissue is subject to HTA licensing requirements and therefore may only be stored under an HTA licence or NHS REC approval.

Once you have notified the HTGO they will work with you to add your human tissue collection to the university's HTA licence.

HTA Licence Contacts