Tissue Transfer Agreement for Human Tissues when Human Tissue Act, 2004 DOES NOT immediately apply (usually for a specific project approved by the National Research Ethics Service, NRES or acellular material)
Explanatory Notes version 3
To check whether the tissues are relevant to the Act or not, please go to:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm
The Parties:
The Recipient and Supplier are the organisations receiving or supplying the Tissues. The Supplier’s Local Investigator may be the immediate custodian of the tissues if the exchange of tissues is not in the context of a collaborative research investigation. In the context of a clinical trial in particular, the Sponsor must agree to the transfer of Tissues.
The Signatories
Each organisation will have recognised individuals authorised to sign on their behalf. The Leeds Teaching Hospitals NHS Trust also deems it essential that, for the transfer of tissues from a diagnostic archive or directly from theatres, the Lead Clinician of the relevant Clinical Unit is party to the Agreement to ensure that a clear audit trail is in place.
Numbering is by reference to the clauses within the Tissue Transfer Agreement (the ‘Agreement’)
1. The Supplier is prepared to supply the Material based upon given information provided within an established Protocol and ethics approval as stated in an ethical opinion. Any changes to this position could fundamentally alter the views of the Supplier. By way of example, the Supplier my have received donations of Material based upon the donor being told that such Material would only be used for specified purposes and only where related ethical approval has been obtained.
2. The purpose of use for Material must be defined and maintained within specified parameters. It is important that the Materials can be traced in terms of audit and responsibility; hence the need to retain the Materials on the Recipient’s premises.
3. The Recipient and the Sponsor will want reassurance that the Supplier has obtained any necessary informed consent/appropriate ethical approval.
4. The Supplier is giving a commitment to deliver the Materials on a specified date or dates and in an agreed format. This commitment is important to avoid any misunderstandings given the reliance that can be placed on both delivery dates and acceptable forms of containment and transportation e.g. any special care that needs to be taken with certain kinds of Materials.
A ‘Tissue Sample Form’ will detail in particular the form of tissues supplied (eg frozen or paraffin embedded), the number of samples and their unique identifier.
5. It is important to record that the Recipient should ensure that those coming into contact with the Materials are aware of the terms of this Agreement. Adherence to the boundaries of consent and ethical approval is not just an issue for the individual signing the Agreement, but all those who may be involved with the Materials.
6. The Supplier is agreeing to pass the Materials to the Recipient based upon understanding that it is only the Recipient that is assessed as an appropriate organisation to receive the Materials. The Supplier must retain control over who may receive the Materials and be able to impose conditions if it agrees to the further transfer of the Materials to third parties. Third parties would be required to sign up to another Tissue Transfer Agreement.
7. The Supplier only wants for the Materials to be used on a non-profit making and research-related basis. However it is accepted that Sponsorship will be required on many occasions to conduct significant research. This is permitted on the assumption that the Recipient is trying to only recover their costs from the Sponsor.
8. The quality of the Material is something over which the Supplier has little or no control and generally would not/could not seek to improve to meet a general standard. The Materials are provided on a ‘as is’ basis. In particular it has to be noted that the Supplier is not making a charge for the Material and conducting the supply as a normal commercial activity.
9. It is important to identify that the local investigator is ‘the person on the ground’ who is deemed day-to-day to have responsibility for ensuring that the Materials are used responsibly in accordance with the Agreement.
10. The Materials are only to be used for their specified activity. If a Recipient is to retain Materials in a hope of their use for other activities this may have very significant problems in terms of ethical approval.
11. If the tissues were taken from a diagnostic archive, when the period of NRES project specific approval comes to an end, any remaining tissues must be returned to the original archive to be stored primarily for future diagnostic reference. Any other tissues relevant to the Human Tissue Act, 2004 (please check link to the Human Tissue Authority website in the opening section of these notes) must be returned to the SUPPLIER and stored in the SUPPLIER’S premises licenced by the Human Tissue Authority.
12. This is an exclusion of liability arising from the use of the Materials. The Supplier is providing the Materials “as is” in good faith, and may have little or no experience of testing Materials for any difficulties associated with the Material.
13. The Supplier has to retain the right in particular to require Recipient to conform to the obligations with the Agreement. The Supplier has to have the opportunity to challenge the Recipient’s use and where it breaches the terms of this Agreement, require ultimately the Recipient to cease using the Materials and return/dispose of such Materials as directed by the Supplier.
14. Ethics committees need to retain the right to control use of the Materials where they are not happy with the Recipient’s handling of the Materials.
15. This clause makes it clear that this is the entire understanding of the parties relating to the Materials.
16. This clarifies that communication should take place between local investigators to avoid confusion.
17. This clause in particular deals with transactions where one of the Parties may be based outside England. The Agreement’s construction was on the assumption that English Law would apply.
18. This makes it clear that only those parties signing the Agreement can rely upon its contents.
Explanatory notes – TTA when the HTA does not apply
09.04.2013 v3 Page 3 of 3