All samples of human origin (“human material”), including “Relevant Material” (HTA link) as defined in the Human Tissue Act 2004 (“HTA”), should move in and out of the Clinical School under a Material Transfer Agreement (“MTA”).
Exceptions
If receiving human material from Addenbrooke’s Tissue banks
In most cases there is no need for an MTA for human material to be transferred between Addenbrookes Hospital and the University. There is an exception however, if a researcher is requesting human material under the Addenbrookes Tissue Bank generic ethics approval. In this case it is necessary for an MTA to be in place and signed by the University Research office. For more information about Addenbrooke’s Tissue Bank go to https://www.cuh.nhs.uk/our-research/research-facilities/tissue-bank/
If receiving human material from Commercial Suppliers
If receiving human material from Commercial Suppliers
Where material is sourced from a commercial supplier the researcher will be expected to provide evidence that the material has appropriate consents for use, either by use of an MTA or via the supplier’s general paperwork and information
Material Transfer Agreements (MTAs)
MTAs are required for research materials (including human material) received into the Clinical School and sent to external parties from the Clinical School. They are negotiated and signed on behalf of the University by the Research Operations Office (“ROO”), who will liaise with the researcher to ensure that their requirements are being met, and will protect both the ongoing research and the University. MTAs must not be signed on behalf of the University by researchers.
MTAs are either negotiated as separate agreements, or included within collaboration agreements.
Applications for MTAs should be made via the ROO portal which can be found at https://researchportal.admin.cam.ac.uk/Raven/submissions/
There are increasing requests to the Research Office for MTAs for sending tissue samples overseas or for sharing of tissue with commercial companies.
Under the Human Tissue Authority Code of Practice and Standards E: Research it is clearly stated that participants should be made aware of
- any intention to share tissue with external academic researchers
- any intention to share tissue with commercial companies
- any intention to send tissue overseas
- any intention to use research in animals
48. To ensure transparency on areas of public concern, for example where research is known or is likely to involve the commercial sector, genetic testing or the use of human tissue in animals, these should be covered in the information used to support the consent process. Where there is an expectation that samples may be exported for use abroad, the HTA also advises that donors are provided with adequate information as part of the consent process
In order to ensure tissue and accompanying data can be shared in these ways we would advise that the following information, or something similar, should be included in the participant information sheet. You may want to adapt/ expand the clause below to suit your study.
Your anonymous samples and anonymous data may be stored for future research and shared with other researchers external to the University. This could include other academics or commercial companies both in the UK and overseas. We will only ever share samples and data that have any identifiers, such as your name or date of birth, removed.
On the Consent form
I understand that, as set out in the information sheet, tissue samples and data given as part of the study will be collected and used for future research including by external organisations in the UK and overseas, and in the commercial sector
Similarly if you intend to use tissue in animal research you should include clauses to cover this. For example on the PIS
Laboratory tests may include the use of animal models
Samples coming in from overseas
MTA templates are normally provided by the party providing the human material. However, due to different regulatory environments this may not be appropriate or even available for University purposes. If this is the case the ROO contracts team can provide the necessary template. The existence of a correctly completed MTA will ensure that the necessary regulatory, ethical requirements and conditions/restrictions of use for both provider and recipient parties are fulfilled.
If it is necessary to involve translators the cost will have to be borne by the relevant department for a certified English translation of the document to be obtained.
Researchers should be aware that although it is not a legal requirement under the Human Tissue Act 2004 for imported human tissue to have consents, the University expects all human tissue to have the appropriate consents/regulatory approvals for use in the University.
Service agreements
Where human material is sent to commercial companies for the sole purpose of analysis with results being sent back to the researcher and the company will not be retaining data or samples then a service agreement can be entered into. There is no need to involve ROO unless there is a collaborative research element between the provider and the recipient. Instead, the service agreement should be handled within the department, in liaison with the University’s Procurement Office.
Storage of “Relevant Material”
The HTA rules on storage apply to “Relevant Material” whether or not it is imported or consented. Consent does not negate the HTA storage requirements. All human material must be stored in a licenced facility or fall into one of the following exemption categories:
- The research is being done under an NHS Research Ethics Committee approval
- The human material is being stored ahead of transfer elsewhere (maximum of 7 days storage allowed)
- The human material is being stored ahead of being rendered acellular (maximum of 7 days)
Who is covered by the Addenbrooke’s Research Licence?
Please be aware that, just because a department is situated within the main Addenbrooke’s hospital building, does not mean that it is covered by the Trust Research licence. For further information please contact the Addenbrookes Tissue Bank https://www.cuh.nhs.uk/our-research/research-facilities/tissue-bank/contact-tissue-bank/
Who is covered by the University of Cambridge Tissue Licence?
The University has a human tissue licence which covers facilities located in the centre of Cambridge and the Vet School. It does not cover any University facilities based on the Cambridge Biomedical Campus. For further information please go to: https://www.safety.admin.cam.ac.uk/system/files/licence_holder_chart.pdf
