There are licensing exemptions in the HT Act 2004 and further specific exemptions in the HT Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006. These regulations came into force on 1 September 2006. The exemptions are summarised below according to whether the material is from the living or deceased.
Licensing exemptions – living or deceased persons
Storage incidental to transportation
The licensing requirements for storage do not include storage which is incidental to transportation. This means that the storage of material while it is being conveyed from one place to another does not need to be licensed. This would normally be a matter of hours or days and no longer than a week.
Storage of relevant material is exempt from licensing if the person storing it is intending to use the material for transplantation, and:
- the material is an organ or part of an organ (if it is to be used for the same purpose as the entire organ in the human body) or
- the storage is for a period of less than 48 hours.
These exemptions continue to apply under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 which came into force on 5 July 2007.
Tissue being held prior to processing
If human tissue is being held while it is processed with the intention to extract DNA or RNA, or other subcellular components that are not relevant material (i.e. rendering the tissue acellular), it is viewed as analogous to the incidental to transportation exception. A licence is not required, providing the processing takes a matter of hours or days and no longer than a week.
Research and ethical approval
An exemption in the Act allows tissue and cells to be stored without a licence for a research project that has appropriate ethics approval [Section 1 (9) of the HT Act 2004]. In addition, consent is not required to store and use tissue from the living for an ethically approved research project if it has been anonymised. Further details are given in our Code of Practice on Research.
The HTA’s remit does not include ethical approval of research on human material, which must be applied for using the guidance provided by National Research Ethics Service (NRES) and the General Medical Council (GMC).
Some specific research ethics committees (RECs) have been authorised to give broad ethics approval for research tissue banks which will then be required to work under NRES standard operating procedures (SOPs). This means that a specified remit of work is permitted without the need for further individual project specific approvals. The tissue in these research tissue banks must be stored on HTA-licensed premises.
REC-approved banks can provide human tissue to researchers; the recipients of the tissue do not need to store it under an HTA licence during the period of the research project, subject to certain requirements. If the research is not carried out in accordance with these requirements, specific project approval by a recognised research ethics committee will be required or, alternatively, the samples will need to be stored under an HTA licence. Information about the requirements governing the release of tissue can be found on the NRES website.
Licensing exemptions – deceased persons
Material more than 100 years old
Storage of material which has come from the body of a deceased person is exempt if the licensed activity relates to the body of a person who died before Section 16 of the HT Act 2004 came into force and at least 100 years have elapsed since the date of the person’s death.
Storage of relevant material which has come from the body of a deceased person, is exempt from licensing if the person storing it is intending to use it for the purpose of ’qualifying research‘ or for a specific research project for which such ethical approval is pending. Qualifying research means research which has been ethically approved by a recognised REC. This can either be a REC established under and operating to the standards set out in the governance arrangements issued by the UK Health Departments or an ethics committee recognised by the United Kingdom Ethics Committee Authority (UKECA), to review clinical trials of investigational medicinal products under the Medicines for Human Use (Clinical Trials) Regulations 2004.
Details of all recognised committees and general information about ethical approval can be found on the NRES website.
Transfer to a tertiary centre for specialised analysis other than research
Under Regulation 3 (4) of the HT Act 2004 storage of relevant material which has come from the body of a deceased person is exempted from licensing if the relevant material:
- has come from premises in respect of which a licence under Section 16 (2) of the Act is in force,
- is stored by a person intending to use it for the sole purpose of analysis for a Scheduled Purpose under the Act other than research, and
- will be returned to premises in respect of which a licence under Section 16 (2) of the Act is in force when the analysis is completed.
Licensing exemptions – living persons
Under Statutory Instrument 1260, storage of relevant material which has come from the body of a living person is excepted where the person storing it is intending to use it for:
- determining the cause of death
- establishing after a person’s death the efficacy of any drug or treatment administered to him
- obtaining information which may be relevant to another person
- public display
- clinical audit
- education or training related to human health
- performance assessment
- public health monitoring
- quality assurance
- qualifying research (see definition above).