SSEHS Material Transfer Agreement

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SCHOOL OF SPORT, EXERCISE AND HEALTH SCIENCES
Material Transfer Agreement Request
1.0
Introduction
If you wish to transport any material, be it biological samples, equipment,
human material or any other article between institutions an MTA (Material
Transfer Agreement) needs to be in place.
A Material Transfer Agreement is a legally binding contract between provider of the
tissue (as defined by the Human Tissue Authority); or, any other material/ equipment
to be transported, and the recipient. An MTA also limits the right of the recipient to
work with materials except under terms agreed by both parties and in compliance
with the Human Tissue Act 2004. Any other relevant legislation for the transport of
material, in instances where non-HTA relevant material is being transported, must
also be complied with.
This agreement is subject to English law and exclusive interpretation by the English
Courts.
2.0
Purpose
The purpose of this document is to source all relevant information, such that an MTA
can be written to govern the transfer and receipt of relevant material between xxxxx
(Originator Institution) and xxxxxx (Recipient Institution). The MTA, once written will
also outline the responsibilities of each party, any relevant disclosures (if applicable)
publication rights, funding restrictions and any other matter, relevant to the transfer
of tissue/ any other materials or equipment between one institution and another.
This agreement does not preclude the need to adhere to other regulatory or legal
requirements relating to supply, receipt, storage, use and disposal of material.
3.0
Responsibilities
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Responsibility for completion of this Material Transfer Agreement rests with the
Originator organisation, who should also keep a copy of the completed agreement as
a record of when the material was transferred and to whom. Systems should be in
place to ensure samples can be tracked from dispatch by the Originator to receipt by
the Recipient.
The Originator agrees to provide the material detailed below on the basis that it has
been collected, handled and stored in compliance with the terms of the Human
Tissue Act 2004. In particular, the Originator assures that the material has been
taken with informed consent for the use specified and that a record of this has been
maintained and that this record will, if required, be provided to the relevant regulatory
authorities. The material is supplied without warranty as to its properties or fitness for
any particular purposes and without any other warranty whatsoever, expressed or
implied.
The material will be forwarded to the Recipient as detailed in the approved version of
the study protocol.
The Recipient agrees to receive the material on the basis that it will be handled,
stored, used and disposed of in accordance with best practise, local policies and the
terms of the Human Tissue Act 2004. The recipient must ensure that all efforts are
made to secure the integrity and security of the material, and that it is used efficiently
and appropriately. In particular the material will only be utilised for the purpose(s)
specified in this Agreement, which are authorised according to the corresponding
Originator consent forms and information sheets. Furthermore, the Recipient shall
not dispose of any remaining material without the Originator’s agreement and shall
ensure that the method of disposal is in accordance with the terms of the Human
Tissue Act 2004.
The Recipient agrees to conform to any requests to provide information on how the
material has been stored and used and disposed of, and to return any remaining
material at any time, if so requested by the Originator, the person from whom the
tissue was obtained or the regulatory authorities.
Any breach of the terms of this Material Transfer Agreement must be notified to the
other party immediately.
4.0
Definitions
Originator Institution: The Institution providing the relevant material.
Designated Individual: The person who is authorised and, supervises the activities
under a licence issued by the Human Tissue Authority.
Relevant Material: The definition of relevant material in the Human Tissue Act is:
Section 53: material, other than gametes, which consist of or include human cells.
References to relevant material from a human body do not include:
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(a) Embryos outside the human body or
(b) Hair and nail from the body of a living person.
Research: Is concerned with creating new knowledge by addressing clearly defined
questions with systematic and rigorous methods.
Standard Operating Procedure (SOP): Detailed written instructions to achieve
uniformity of the performance of a specific function.
4.0
Confidentiality
The Recipient must not disclose any information whatsoever with regards to the
material and its use, to anyone other than the authorised personnel carrying out the
investigation, without written approval of the Originator. Information with regards to
the material must only be utilised for the indicated use.
Any requests regarding access or retrieval by the test subject or their representative
must be complied with.
The Originator and Recipient must operate in accordance with the Data Protection
Act 1998.
5.0
Publishing
The Recipient must acknowledge the contribution of the Originator institution in any
publication that may result from the use of the materials. Advance copies of any
paper, including student work (thesis), to be published must be sent to the Originator
for review.
If there are publications likely to arise from the use of the material it must be agreed
prior to any publication/ presentation/ oral disclosure of work arising from the use of
this material, whom is to be credited for the work. This must be discussed with the
Originator Institution and all points agreed set out in writing.
6.0
Intellectual Property
If there is any potential Intellectual Property (IP) likely to arise from the use of the
material this must be discussed with the Originator Institution. The policy surrounding
IP should be written such that all legal considerations from all parties are taken into
account.
7.0
Safety
The Originator shall inform the Recipient of any known biological Hazards associated
with the sample, and the Recipient takes responsibility for the appropriate
management and handling of the sample.
8.0
Funding Arrangements
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All funding arrangements for the project using the material provided must be
transparent.
9.0
Transport of Material
Transport must take place in a safe manner that will ensure the security and integrity
of the samples during transit. A system should be in place to ensure that the material
has been received safely, and stored appropriately.
10.0 GENERAL DETAILS
Study Title
Proposed start
date
End date
(if applicable)
Principal
Investigators
(please include
name, address,
email, telephone &
fax details for each)
Originator
Institution
contact details
Recipient
Institution
contact details
HTA ‘relevant
materials’
Other materials
Reason for
transfer
Responsibility
for transport
costs
Loughborough University
Responsibility
for arranging
transport
Loughborough University
How the
material will be
used
(Please provide a
very brief
description of the
intended permitted
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use of the Material)
About the
Source material
(Please provide
brief details of your
research work in
terms of timings
and location of the
Material, from its
source until it is
disposed/stored)
How the
samples be
anonoymised
(please provide
details of the
process)
Any information
that the
Recipient will be
given relating to
the test subject
Has a risk
assessment
been carried
out? Please
evidence this!
Please provide
evidence of
consent (supply a
sample consent
form)
How the
research project
is funded
Originator
Institution
Designated
Individual (DI)
(Where applicable)
Recipient
Institution
Designated
Individual (DI)
(Where applicable)
Originator
Institution HTA
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12577
License number
(Where applicable)
Recipient
Institution HTA
License number
(Where applicable)
How is the
sample being
transported?
Please state
whether your
method of
transport
(+packaging)
complies with
HTA legislation.
Details of
ethical approval
to use this
material
Any patent
issues
surrounding this
material
Any other
constraints on
the use of the
material
Specific issues
relating to
publication
and/or IP (Will
there be any IP
generated from the
transfer of materials)
Other
Details for the
planned
disposal of any
surplus material
at the end of the
permitted use (in
compliance with the
requirements of
consent provided)
10.0
Signatures
The signature of the Principal Investigators and Designated Individuals of the
receiving organisation signifies the Recipient’s acceptance of the above by signing
and dating two copies of this Agreement and returning both copies to the Originator
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Institution. Upon receipt of two completed and signed copies of this Agreement, and
any other documents required, the material will then be sent to the Recipient.
Recipient’s Principal Investigator:
Originator’s Principal Investigator:
Signature:
Signature:
Name (print):
Name (print):
Date:
Date:
Title/Position:
Title/Position:
Recipient’s Designated Individual:
Originator’s Designated Individual:
Signature:
Signature:
Name (print):
Name (print):
Date:
Date:
Title/Position:
Title/Position:
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