SOP 7 Appdx D [DOCX 38.00KB]

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Appendix D
Instructions for Incoming Human Tissue to Sussex for Research Purposes
You should use this form where Human Tissue is to be transferred from a third party to Sussex for research purposes.
1. QUESTIONNAIRE
SUSSEX’S PRINCIPAL INVESTIGATOR DETAILS
Name
Office Address
School
Telephone No.
Email
PROVIDER INSTITUTION DETAILS
Name of Provider Institution
Name of School/Department
Address of Provider Institution
Name of Contact at Provider
Institution
Email for Contact
CHECKLIST
1.
Is the Provider Institution Licensed by the Human
Tissue Authority?
2.
If the answer to item 1 is “Yes”, please provide
the Provider Institution’s Human Tissue Authority
Licence No.
3.
Have you attached the Provider’s MTA?
If “No” is Sussex to provide the MTA?
THE MATERIALS
4.
Description of Materials to be transferred
(please be as detailed as possible)
5.
Quantity of Materials to be transferred
6.
Is there or will there be “appropriate consent”, as
required by the Human Tissue Act 2004, which
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permits the use of the Materials in your research?
If “No”, please explain why consent is not required
7.
Are the Materials coming from a source (e.g.
study or tissue bank) that has been ethically
approved?
If “Yes”, please provide “NRES” Approval Number:
If “No”, do you intend to obtain:
NRES approval?
C- REC (for healthy volunteers) ?
8..
Are the Materials known to be toxic, infectious or
in any other way dangerous?
9.
What conditions of storage will apply to the
Materials?
USE OF THE MATERIALS BY SUSSEX
10.
Please identify all individuals who will have
access to/use the Materials and for each give
their status (e.g. University of Sussex employee,
University of Sussex student (not BSMS),
University of Sussex student (BSMS), visiting
researcher, Brighton & Sussex University
Hospitals NHS Trust employee, Collaborator
employee,
Sub-contractor
employee,
Consultant):
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11.
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What will Sussex do with the Materials? (please
give a description of the research which the Recipient Scientist
will carry out using the Materials – this will go into the MTA)
12.
Will all of the work using the material be carried
out on University of Sussex/BSMS premises at
Falmer?
If “No”, please state where the work will be
carried out
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Do you intend to modify the Material in any
way?
If “Yes”, please give details:
14.
Do you intend incorporating the material into
something else or combining it with other
material?
If “Yes, please give details of the other materials
and the name of the organisation that provided
them.
If you are aware of an MTA for the other
materials please specify the date of signing.
15.
Has a protocol or outline of the research in
which the Materials will be used been drafted?
16..
How is the research you will carry out with the
Materials funded? (Please include the research
project code)
17.
Are there any other contracts that would be
relevant to the MTA and/or your work with the
Materials?
(If “Yes” please attach a copy)
If “Yes”, please give details of the agreements and
the parties thereto. (Relevant contracts would
include any connected funding or grant
agreement, MTA, NDA and also any Collaboration
Agreement governing the research in which the
Material are being used)
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18.
For how long will you need to retain the
Materials?
19.
What results are you hoping to obtain from your
research and will they have commercial value?
20.
What use(s) (e.g. academic publication, thesis,
future research, commercial use) will or may be
made of the results generated from use of the
Materials?
21.
Do you intend to apply for non-commercial or
commercial funding to conduct further research
with the results?
22.
When you have finished using the Materials, are
the Materials and any data provided with them
to be destroyed or will any remaining Material
and data provided need to be returned to the
Provider Institution?
2. DECLARATION BY THE PINCIPAL INVESTIGATOR
(i)
I am an employee of the University of Sussex.
(ii)
I have checked and satisfied myself that the transfer of these Materials is permitted either by the
consent(s) given or because the Materials are able to be used without consent, and that there is no
other reason to the best of my knowledge why the transfer to Sussex should not be made.
(iii)
I understand that if Sussex signs the MTA, I will be personally responsible for ensuring that Sussex
complies with its terms.
Signed by the Sussex’s
Principal Investigator _______________________________________________________
Date of signature__________________________________________
Please email a scan of this form, with an electronic copy of the, provider Institution’s MTA (if provided), the research
summary or protocol (if applicable) and other documents required to Contracts.Instructions@sussex.ac.uk or send a
hard copy of all documents to Contracts & IP, 2 nd Floor, Falmer House, marked as “MTA Request”. The Contracts
Team will then, provided it is satisfied with the information given, either review the Provider Institution’s MTA or if one
has not been provided, prepare the MTA . The matter will be allocated to a member of the Contracts Team who will
contact you if further information is required by the Contracts Team and deal direct with the Provider Institution’s
contact in order to agree the MTA..
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