Material Transfer Agreement (“MTA”)
What is “Human Tissue?”
Human Tissue can be defined as that which consists of or includes human cells and includes any modified versions thereof.
What is “Material?”
Material can be defined as any biological fluid or derivative thereof whether consisting of human cells or not. For example serum is not considered ‘relevant material’ within the remit of the Human Tissue Act 2004 however for the transfer of material out of the Trust an MTA is required to complete the transfer.
The purpose of an MTA is different to the regulatory provisions provided for under the Human Tissue Act 2004 which governs the storage, removal and use of human tissue for a scheduled purpose which includes research use. These two issues should not be confused as being one and the same
When is one needed?
An MTA should be in place between NUH as ‘Provider’ of the material and the institution or ‘Recipient’ to where the material is being transported for non-commercial research. An MTA is required whenever tissue and/or material is being transferred out of the Trust and includes transfers to the University of Nottingham.
NUH Trust and the University of Nottingham are currently generating a Memorandum of Understanding to facilitate the transfer of material between the entities in a pragmatic and efficient manner. In the interim period an MTA must be executed for each transfer in accordance with Trust Policy. Professor Jim Lowe is the University authorised signatory for this purpose.
Commercial research studies utilising the industry standard template (NHS-ABPI-BIA model Clinical Trial Agreement 2006) does not require an additional agreement for the transfer of material.
Individual researchers/clinicians/study team members are not authorised to sign an MTA on behalf of the Trust. Material being transferred for ethically approved/pending approval research studies should be transferred following a fully executed MTA which has been signed on behalf of the Trust by R & D. The requirement of an MTA to be in place is distinct from the statutory licence required from the Human Tissue Authority (HTA) be held for the use, storage or removal of human tissue for scheduled purposes. Material collected for use in an ethically approved research study does not require a HTA licence to be held by the site/institution collecting samples.
Why is this needed?
NUH has a duty of care to its patients to ensure that any samples provided for research purposes are handled in an appropriate and ethical manner. The Trust takes its responsibility towards its patients seriously and to that end requires transparency in all of its transactions and its actions to be accountable.