Tissue Transfer Agreement for Tissues relevant to the Human Tissue Act, 2004
Explanatory Notes version 2
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
Designated Individuals are those registered with the Human Tissue Authority in the context
of the Human Tissue Act, 2004. There may not be a Local Investigator in the Supplier’s
organisation if the exchange of tissues is not in the context of a collaborative research
project, in which case the immediate custodian of the tissues will be regarded as the
Supplier’s Local Investigator. 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. It is
essential that Designated Individuals in both organisations are aware of the exchange of
Tissues in order to ensure local compliance with the Act. The Leeds Teaching Hospitals
NHS Trust also deems it essential that, for the transfer of tissues from a diagnostic archive,
the Head of the relevant Department 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. Recipients need to understand that the Human Tissue Act continues to apply to their use
of Materials and continue to sign up to the commitments contained within that Act. The
Supplier’s designated individual can provide further guidance where the Recipient is
unsure about compliance issues.
5. 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.
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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.
6. 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. Compliance is not just an
issue for the individual signing the Agreement, but all those who may be involved with
the Materials.
7. 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.
8. 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.
9.
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.
10. 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. Any concerns with regard to compliance
by the Recipient will most likely be addressed to the local investigator in the first
instance.
Standard operational procedures are important in that they provide the practical detail
behind the general legal commitments. Without having standard operational procedures
the Supplier will have less confidence that the Recipient has really understood the full
extent of legal commitments relating to human tissue. Copies of the Supplier’s standard
operational procedures can be obtained from the Supplier’s designated individual. It is
reasonable to expect that any Recipient will as a minimum comply to standards expected
by the Supplier.
11. 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.
12. 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.
13. 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 licensing and ethical approval.
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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 designated individuals 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.
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