Code E: Licensing

80.    This section explains where, in the context of research, a licence from the HTA is needed and where exceptions to licensing requirements apply.

81.    The storage of human tissue for research, and its removal from the deceased, is licensed by the HTA. The HTA does not license the ‘use’ of tissue for research and it does not have a role in approving individual research projects.

82.    The HT Act does not define the term ‘storage’ and does not give any minimum or maximum term for storage of human tissue for research.

83.    As there is no set time period for storage, we encourage researchers instead to consider whether they are actually storing material for research in the normal usage of that term; for example, to think about the context in which they plan to hold relevant material and their intention. We provide some examples below to help clarify the concept of storage requiring a licence.

84.    A licence to store relevant material for research within the scope of the HT Act is not required in the following circumstances:

85.    Imported tissue stored for research should be treated in the same way as tissue originating from participants in England, Wales or Northern Ireland. This means that the same exceptions to licensing apply. More information about imported material is provided later in this Code.

86.    In addition to the exceptions above, there is a broader exception set out in the HT Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006. These Regulations allow human tissue held for a specific research project approved by a recognised REC (or where approval is pending) to be stored on premises without a HTA licence. An application for ethical approval is pending from the point it has been submitted until the decision of the committee has been communicated to the applicant.

87.    The HTA advises researchers to consider the need for ethical approval before embarking on any research. A HTA licence should not be viewed as an alternative to ethical approval by a recognised REC.

88.    While there is a relationship between ethical approval from a recognised REC and some of the requirements of the HT Act with regard to research, the need for ethical review should be considered separately and in parallel with the legal requirement for a licence. Decisions about the need for ethical review are governed by institutional (e.g. local policies) and/or wider arrangements (e.g. the GAfREC framework or legal requirements, such as the Mental Capacity Act 2005 and in Northern Ireland the Mental Capacity Act (Northern Ireland) 2016) and should be informed by potential ethical concerns raised by proposed research, whether or not the research involves human cellular material.

89.    Once human tissue is no longer being stored for a project approved by a recognised REC (or one where such approval is pending), it must be stored on HTA-licensed premises if it is intended for a scheduled purpose. Where it is to be used for further research that does not have recognised REC approval, the research must be in accordance with the initial consent obtained or, if appropriate, further consent should be obtained. The need for further ethical review would also need to be considered as outlined in the previous paragraph.

90.    The HTA and the HRA’s Research Ethics Service (HRA RES) have agreed a position whereby its RECs can give generic ethical approval for a research tissue bank's arrangements for collection, storage and release of tissue, providing the tissue in the bank is stored on HTA-licensed premises. Such research tissue banks need to be licensed because at least some of the tissue being stored is not for specific projects holding REC approval.The banks are also required to work under HRA RES Standard Operating Procedures (SOPs). Applications for ethical review of research tissue banks are voluntary. Subject to conditions, the bank’s ethical approval extends to specific projects receiving non-identifiable tissue from the bank. The tissue does not then need to be stored on HTA-licensed premises for the duration of the project; nor does it need project specific ethical approval. If the research is not carried out in accordance with these requirements, specific project approval by a recognised REC will be required or, alternatively, the samples will need to be stored under a HTA licence. Information about the requirements governing the release of tissue can be found on the HRA website. The RECs are also a source of ethical advice to the bank on its arrangements for collecting, managing and distributing tissue. In particular, the RECs can advise on informed consent and procedures for providing feedback to participants. Ethical approval for a research tissue bank offers additional assurance to end user researchers, donors and the public that its operations meet the highest ethical standards.

91.    If the research tissue bank does not have broad ethics approval, human tissue from the bank must be stored on HTA-licensed premises unless a storage licensing exemption applies; for example, the researcher has obtained specific project approval by a REC.

92.    On completion of research using tissue from a REC-approved research tissue bank, the individual researcher must transfer the tissue back to the bank or to an alternative HTA-licensed establishment, apply for their own HTA licence (unless there are existing local licensing arrangements which can be used tocover the further storage), apply for specific project approval by a REC or dispose of the human tissue.
 

93.    Tissue may need to be disposed of because, for example the consent does not permit its broad use for research, or (in rare instances) consent has been withdrawn. Further information about disposal can be found later in this Code.

94.    Tissue that is taken from the living for diagnosis and subsequently stored in a diagnostic archive can be a valuable research resource. Purely diagnostic archives do not need to be stored on HTA-licensed premises as no licensable activity would be taking place. However, the HT Act clearly provides that the storage of tissue for a ‘scheduled purpose' must be on licensed premises. The HTA’s position is that if a diagnostic archive releases tissue for research occasionally upon request, its status as a diagnostic archive is clear. However, if there is an expectation that tissue will be released on a regular basis, then it may cease to be a purely diagnostic archive, particularly where there are developed governance / decision-making structures and procedures for applying for tissue.

95.    Where a diagnostic archive functions as a resource for researchers as it invites applications for the release of samples, and/or in any way advertises the archive as a research resource, it is functioning as a research tissue bank. It must therefore be encompassed within the HTA's licensing framework. This legal requirement stands, even where tissue released from the archive will only ever be used as part of a specific project approved by a NHS REC.

96.    Where the archive is on premises already licensed by the HTA for storage, providing the DI is willing to take responsibility for the governance of the archive, the licence can be extended in anticipation of the archive operating as a research tissue bank.

97.    Where the archive is on premises not licensed by the HTA for storage, a new licence application will need to be submitted prior to the archive operating as a research tissue bank.

98.    The import and export of relevant material is not a licensable activity under the HT Act. However, the storage of the material once it is imported may be licensable if this is for a scheduled purpose, such as research within the scope of the HT Act.

99.    The geographical scope of ‘import’ and ‘export’ according to the HT Act is as follows:

a)    ‘import’ means import into England, Wales or Northern Ireland from a place outside England, Wales and Northern Ireland;
b)    ‘export’ means export from England, Wales or Northern Ireland to a place outside England, Wales and Northern Ireland.

100.    Tissue may be imported for use in research projects. A licence may not be needed to store this material in some cases where it is being kept for use in a research project that has been approved by a recognised REC (see paragraphs 86-88). The HTA recommends that, wherever possible, the import and export of tissue is conducted via the HTA licensing regime, which involves a DI ensuring that premises are suitable for activities as authorised by the licence.

101.    Imported material should be procured, used, handled, stored, transported and disposed of in accordance with the consent which has been obtained.

102.    All persons or organisations wishing to import human bodies, body parts and tissue into England, Wales and Northern Ireland should be able to demonstrate that the purposes for which they wish to import such material cannot be adequately met by comparable material available from sources within those countries, or is for a particular purpose which justifies import. Importers should assure themselves of the integrity of the material and that, as a minimum, it has been sourced with appropriate consent. They should be able to satisfy themselves and document the need for importing in terms of accessibility, quality, timeliness of supply, risk of infection, quality of service, cost effectiveness, or scientific or research need. Such documentation should be available for inspection by the HTA.

103.    The HT Act makes consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts and tissue from the living or the deceased, for the purposes specified in the HT Act. The consent provisions of the HT Act do not apply, however, if the material has been imported. Nonetheless, the HTA considers it good practice to ensure mechanisms are in place in the source country for obtaining consent.

104.    The importer should have in place, policies and/or SOPs which clearly set out the evidence indicating how informed consent was obtained, including safeguarding the confidentiality of all information relating to consent. If a separate organisation is importing the material, a documented agreement should be in place demonstrating that there is a record of consent in a suitable format.

105.    Importers should satisfy themselves, with due assurance from their partners abroad, that any material intended for import is sourced consistently with the legal and ethical review requirements in England, Wales and Northern Ireland. When an establishment imports material into England, Wales and Northern Ireland for research, it is good practice for approval to be obtained from a research ethics authority or the local equivalent in the source country beforehand. Many countries have research ethics arrangements which operate to agreed standards. The ethical review in the source country may, in some cases, be considered to provide suitable assurances for the import of material into England, Wales and Northern Ireland.

106.    If the importer of the material cannot ensure that ethical standards have been put in place, any potential risks of accepting such material should be carefully considered.

107.    The supplier’s record and other documentation of each consignment of imported human bodies, body parts and tissue should be retained by the person undertaking the export for at least five years after disposal of the last item included in the consignment. The register maintained by the person undertaking the import should, similarly, be retained for at least five years after disposal of the last body item recorded in it.

108.    Unless stipulated otherwise, the disposal arrangements for imported material should meet the requirements of the HT Act and the HTA’s Codes; in other words, as though the material had been sourced from England, Wales and Northern Ireland.

109.    If any specific requests were made by the deceased regarding disposal when consent was obtained, such requests must be carried out. This may include, for example, the return of material to the country of origin.

110.    Imports (and exports) of human tissue must normally be declared to HM Revenue and Customs.

111.    Material to be exported should be procured, used, handled, stored, transported and disposed of, in accordance with the consent which has been given, with due regard for safety considerations and with the dignity and respect accorded to human bodies, body parts and tissue provided for in Codes in England, Wales and Northern Ireland. This includes providing donors with adequate information when obtaining consent, to the effect that their samples may be exported for use abroad.

112.    It is the responsibility of the recipient country to ensure that, prior to export, the material is handled appropriately and that the required standards of that country have been met.

113.    Documented agreements should be in place to ensure that human bodies, body parts and tissue to be exported from England, Wales and Northern Ireland are used in accordance with the consent which has been obtained. Material should be handled, stored, transported and disposed of, in a manner consistent with safety considerations, and with the dignity and respect accorded to human bodies, body parts and tissue in legislation and in Codes in England, Wales and Northern Ireland.

114.    The HT Act makes it clear that bodies and relevant material are not to be exported and then re-imported simply to avoid the Act’s consent requirements.