The Human Tissue Act 2004 (HT Act) is an act of UK parliament applying to England, Wales and Northern Ireland. It established the Human Tissue Authority (HTA) to regulate the removal, storage and use of relevant material. Relevant material is defined as material that has come from a human body (other than gametes) and consists of, or includes, human cells. If a sample is known to contain even a single cell that has come from a human body, then the sample should be considered relevant material.
Relevant material includes...Relevant material includes...
- Bone marrow
- Breast milk
- Buffy coat layer
- Cerebrospinal fluid
- Cystic fluid
- Foetal tissue
- Fluid from cystic lesions
- Hair from a deceased person (not from a living person)
- Joint aspirates
- Nail from a deceased person (not from a living person)
- Nasal and bronchial lavage
- Non-blood derived stem cells
- Non-foetal products of conception (i.e. the amniotic fluid, umbilical cord, placenta and membranes)
- Pericardial fluid
- Pleural fluid
- Primary cell cultures
- Sputum (or phlegm)
- Stomach contents
- Tumour tissue samples
- Umbilical cord blood stem cells
For further details, please see the Human Tissue Authority guidance.
Consent is required for scheduled purposesConsent is required for scheduled purposes
Under the HT Act, the removal, use or storage of relevant material for the following activities, referred to as scheduled purposes, requires consent:
Where the relevant material is from the living or deceased:
- Anatomical examination
- Determining the cause of death (except where ordered by a coroner)
- Establishing, after a person’s death, the efficacy of any drugs or other treatments administered to him/her
- Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person)
- Public display
- Research in connection with disorders, or the functioning, of the human body
Where the relevant material is from the deceased:
- Clinical audit
- Education or training relating to human health
- Performance assessment
- Public health monitoring
- Quality assurance
It is an offence to remove, use or store relevant material for a scheduled purpose without consent. It is also an offence to falsely represent that there is appropriate consent to do an activity, or that the Act does not apply.
However, the requirement for consent for the above scheduled purposes is subject to several exemptions. It is not legally necessary to obtain consent under the HT Act:
- To store or use an existing holding for a scheduled purpose, where an existing holding is bodily material from the living or the deceased that was obtained prior to 1st September 2006.
- To undertake research on relevant material, where the relevant material was donated for research and more than 100 years have elapsed since the donor’s death.
- To store or use relevant material for research where all of the following apply:
- The relevant material was taken while the person was alive.
- The researcher is not in possession or likely to become in possession of information that identifies the person from whom the relevant material has come.
- The material is used for a specific research project with approval from a HRA Research Ethics Committee (REC).
Acquiring consent for use of relevant material from a deceased person
Ideally, informed consent should be obtained from the donor prior to death. If this is not possible, a legally nominated representative may provide consent on behalf of the donor. If there is no known legally nominated representative, someone in a qualifying relationship to the donor may provide consent. For more information, please see: https://www.hta.gov.uk/policies/qualifying-relationships.
Researchers must be trained in seeking consent
Under the HT Act, researchers must have completed appropriate training for seeking consent. Please contact Kay Howes for further information.
DNA is not considered to be relevant material, however under the HT Act
- analysing DNA
- holding DNA for analysis or
- analysing RNA to provide DNA information
without consent is an offence.
Licensing and approvalsLicensing and approvals
Under the HT Act, any premises that stores relevant material must have been issued a licence by the HTA, unless:
- The relevant material is obtained from a HTA licensed research tissue bank,
- The storage is incidental to transportation (storage for no longer than seven days),
- The relevant material is stored with the intention to render acellular (storage for no longer than seven days),
- The relevant material is more than 100 years old, or
- The relevant material is stored as part of a specific research project that has received approval from a HRA REC, (though arrangements should be in place for storage at the end of the project, to comply with the licensing standards).
Newcastle University holds a licence issued by the HTA to collect and store human tissue for research purposes. Accordingly, the university must meet the standards set by the HTA. Dr Christopher Morris is the university’s designated individual for implementing the requirements of the HT Act, i.e. ensuring:
- That suitable practices are used in undertaking the licensed activity
- That other persons working under the licence are suitable, and
- That the conditions of the licence are complied with.
In order to help satisfy these requirements, it is important that researchers inform the designated individual of any research that they plan to undertake/are undertaking that involves relevant material. Specifically, you will need to provide the following information: a description of the relevant material, the location of the sample, the name of the principal investigator, which study it is being used for.
Researchers using relevant materialResearchers using relevant material
Researchers using relevant material at Newcastle University must ensure that they:
- Are familiar with the rules governing its use, and have reviewed the Code of Practice and Standards developed by the HTA.
- Complete the mandatory Human Tissue e learning module within Blackboard. (To gain access to the module, please email email@example.com).
- Inform Dr Christopher Morris of their research, specifying: a description of the relevant material, the source of the sample, the location of the sample, the name of the principal investigator, which study it is being used for.
- Have agreed a Material Transfer Agreement (MTA) for material coming into the University from an external organisation.
- Are aware of the specific locations at Newcastle University that have been approved as suitable for taking relevant material. If researchers wish to include another location, the location must first be assessed and approved. For further information, researchers should contact Kay Howes.
- Are aware of the specific locations at Newcastle University that have been approved as suitable for storing relevant material. If researchers wish to include another location, the location must first be assessed and approved. For further information, researchers should contact Dr Christopher Morris.
Taking blood samplesTaking blood samples
Blood should only be drawn by a competent person or by someone working under the direct supervision of a competent person, where a competent person is:
- a registered medical practitioner
- a trained phlebotomist
- another Newcastle University staff member who has been trained in the UK and certified as competent in writing by a registered medical practitioner or a recognised trained phlebotomist.
Blood should only be taken in a location that has been approved for this purpose. For further information, please contact Kay Howes.
If you wish to recommend any changes to the information above, please contact firstname.lastname@example.org.