The Human Tissue Act
The Human Tissue Act 2004 regulates the removal, storage, use and disposal of Relevant Material. There are many different types of human tissue and cells, including skin, body parts, organs and bone. Any sample derived from a human body that contains even a single cell is deemed to be Relevant Material. View further details of HTA Relevant Material guidance.
The Human Tissue Authority (HTA) is the regulatory body that oversees compliance with the Human Tissue Act. It licenses and regulates six different sectors, including research.
Informed consent is the backbone of the Human Tissue Act, though there are exemptions.
HTA Codes of Practice
The HTA produces ten Codes of Practice to provide guidance on human tissue legislation. The following Codes of Practice are relevant to the Research Sector:
- Code of Practice A - Guiding principles and the fundamental principle of consent
- Code of Practice E - Research
- Code of Practice E - Research Standards and Guidance
Further information on the HTA and the Human Tissue Act can be found at https://www.hta.gov.uk/.
The HTA produce Standards that they expect establishments holding a licence to adhere to. The Standards cover four areas; consent, governance and quality systems, premises, facilities and equipment and disposal. HTA-licensed establishments are inspected to ensure that the standards are being met and produce compliance reports of inspections. A copy of the HTA Standards for Research can be found at https://www.hta.gov.uk/guidance-professionals/hta-standards.
The new Standards came into force in April 2017.
Any establishment in England, Wales and Northern Ireland removing and storing human tissue samples, for the scheduled purpose of research, must have a HTA licence, unless an exemption applies. The HTA licence permits the storage of the material. Research Ethics Committee approval is required to use the material in a research project.
Training on the Human Tissue Act and the use of clinical information
All staff using human tissue must be aware of the rules governing the use of human tissue, set out in the Human Tissue Act, and be competent to work to the HTA (Human Tissue Authority) Standards for Research. Research staff, students and newly appointed Principal Investigators must provide evidence that they have undertaken training in the Human Tissue Act, if they are performing research involving human samples.
Human tissue includes anything derived from a human being including blood and blood products, tissue, cells, urine, sputum, faeces etc. The HTA regulates all cellular material with the exception of gametes, which are regulated by the HFEA. For example, blood is regulated by the HTA and deemed to be 'relevant material' however some blood derivatives, such as plasma and serum, provided they are processed appropriately, are not regulated by the HTA as they are considered to be acellular.
It is vital that researchers are aware of when and how their research is regulated under the Human Tissue Act. The MRC online toolkit provides an e-learning course http://www.byglearning.co.uk/mrcrsc-lms/course/.