Research Involving Human Samples
The use of human tissue in research is highly regulated to protect tissue donors, their families and researchers. All staff and students who work with human tissue are required to comply with relevant regulatory and legislative requirements. Human tissue which is specifically governed by the Human Tissue Act 2004 (The Act) is termed ‘relevant material’. A joint quality management system (QMS) is in place across Swansea University and Abertawe Bro Morgannwg University Health Board to govern the use of human tissue in research.
Relevant material as defined by the Act 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 Human Tissue Authority (HTA) list of relevant material for a comprehensive guide to the types of human material covered by the Human Tissue Act.
The following are excluded from the act:
- Hair and nails from the body of a living person
- Embryos created outside the human body
- Cell lines
- Extracted cellular components
- Acellular material
The Act, covering England, Wales and Northern Ireland came into full effect on September 1st 2006 to act as a legal framework for the regulation of the removal, storage, use and disposal of human bodies, organs and tissues. The 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 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.
University ethics committee approval is not sufficient to comply with legislation for the storage of relevant material for research.
Researchers using human samples are encouraged to seek advice from the Human Tissue Act Governance Officer abm.HTA@wales.nhs.uk on the REC approval and HTA licensing requirements at the outset of the study.
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 and NHS R&D permission (where appropriate).
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 overseen by the Designated Individual. This also applies to any other associated clinical data, which must be stored in accordance with the Data Protection Act (1998) with full consideration of donor confidentiality.
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 have 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.
To comply with this requirement, planned tissue use should be notified to the HTA Governance Officer for review in the first instance. Advice on the legal storage of samples will be provided at this point to assist researchers in maximising the potential to retain valuable tissue at study end.
Principal Investigators who plan to use or store human tissue for a research study must complete and submit HTA-08-FORM-Declaration of Planned Human Tissue Use to the HTA Governance Officer before the study is submitted to NHS REC or University Ethics Committees. No human tissue collection should commence before this form is submitted or agreement to proceed is received. A risk assessment may be required before study commencement.
The Human Tissue Governance Officer MUST be notified by email to abm.HTA@wales.nhs.uk in the following circumstances:
Where the collection, use and storage of human tissue from patients or healthy volunteers is part of a new study, including tissue obtained from a diagnostic archive (e.g. Histopathology). Principal Investigors must complete and submit HTA-08-FORM-Declaration of Planned Human Tissue Use before the study is submitted to NHS REC or University Ethics Committees. No human tissue collection should commence before discussion with the HTA Governance Officer or Designated Individual.
Where human tissue is being imported or exported for any research study. Principal Investigators should complete and submit HTA-05-FORM-Authorisation to Import Human Tissue where tissue is to be imported. No human tissue may enter the university or ABM University Health Board from outside England, Wales or Northern Ireland before agreement is issued by the DI or HTA Governance Officer.
Where tissue is purchased from commercial sources; commercial tissue is subject to HTA licensing requirements therefore may only be stored under a HTA licence or NHS REC approval.
Human Tissue Quality Management System
The joint QMS aims to ensure appropriate levels of:
Compliance with the HT Act, HTA standards and HTA Codes of practice
Risk mitigation for donated tissues and researchers
Quality assurance to maintain and enhance organisational reputation
Confidence in donors in providing samples for research
The QMS includes a number of Standard Operating Procedures (SOPs), templates and forms which have been developed in line with the HTA Codes of Practice. Templates may be adapted by researchers and renamed as local documents for specific studies.
Human Tissue Act Training
Any individual working with human tissue for research should complete the MRC Human Tissue Legislation training module http://byglearning.co.uk/mrcrsc-lms/ (select ‘Regulatory Support Centre’, ‘e-learning’, ‘Research and human tissue legislation – updated’) and the associated assessment. For researchers working under the HTA licence, successful completion of this training is mandatory. Copies of certificates should be submitted to the HTA Governance Officer at abm.HTA@wales.nhs.uk