LABORATORY OF CELLULAR - Trinity College Dublin

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The Rare Kidney Disease
Registry & BioBank
The Rare Kidney Disease Registry and BioBank
The Institute for Molecular Medicine
St. James Hospital
Dublin 8
Service Level Agreement for provision of services for biobanking of human biological samples.
The Depositor:
Title of Sub-bank:
Name:
Address:
Contacts:
Name:
Name:
Telephone:
Telephone:
e-mail:
e-mail:
The BioBank:
The Rare Kidney Disease Registry BioBank
The Institute for Molecular Medicine,
St. James Hospital
Dublin 8.
Contacts:
Prof. Mark Little
Consultant Nephrologist
Telephone: 01-8963844
e-mail: [email protected]
Ms Valerie Logan
Biobank Coordinator
Telephone: 087 6560962 /Lab: 01-8963383
e-mail: [email protected]
Abbreviations:
Trinity College Dublin
Standard Operating Procedures
Service Level Agreement
Rare Kidney Disease
Material transfer agreement
TCD
SOP
SLA
RKD
MTA
1. Service Description
The RKD BioBank aims to:
o facilitate research into kidney diseases with a prevalence of <5/10,000
o provide ethically robust mechanisms for storage of human samples in a sub-bank
Service Level Agreement: RKD BioBank
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o
o
enhance availability of TCD Rare Kidney Disease Registry Biobank holdings to researchers
within TCD, Nationally and Internationally.
Enable the deposits to remain the property of the Depositor
The BioBank will:
 Provide assistance with sample processing
 Provide training in sample processing if required
 Provide advice on which samples to archive for a given study
 Provide consumables such as barcoded labels, sample collection kits/processing kits/data collection
forms if required.
 Provide receipt of samples and storage for a period subject to the criteria described in Section 6.
 Provide a seamless link to high quality validated DNA extraction services, provided by the TCD
Biobank. The arrangement for this will ultimately be between the Depositor and the TCD Biobank. A
charge will be levied by the TCD Biobank for this service (currently about €10 per case).
The Biobank provides a flexible approach to banking and allows the Depositor to pick and choose their
services they require to fit their requirements. The samples remain the property of the Depositor.
Collaborations arising from publicising of the holdings are entirely at the discretion of the Depositor.
The BioBank is currently funded by Science Foundation Ireland; while this funding is in place there will be no
monetary charge for depositing samples. Transport costs of sending samples to collaborators will be borne
by the Depositor. Aliquot archiving for a period of up to 3 years is provided free of charge. After this time, a
small maintenance charge (€5/aliquot/year) will be levied.
2. The Depositor’s responsibilities:
1. The Depositor must ensure that appropriate consent has been obtained for all samples and data
entered in the Biobank
2. The Depositor must ensure appropriate ethical approval has been obtained for the study under
which the samples are being collected, and provide of this a copy to the Biobank
3. If not using the RKD ethical framework, the Depositor must ensure that the ethics allow storage of
samples and linked data in the Biobank
4. The Depositor should ensure that samples being transferred to the bank are done so following
regulations governing the transport of biological samples
5. The Depositor shall confirm details of delivery of samples to Biobank, including accurate estimated
time of arrival of samples
6. The Depositor shall provide accurate identifiers on samples coming in to BioBank
7. The Depositor will undertake to make payment within 28 days of the date of the invoice, for services
provided by the Provider in the SLA against the schedule of costs, see Appendix1.
8. The Depositor must ensure appropriate disposal of any samples released to them by the BioBank.
This includes any material passed on to a third party for ethically approved research studies, which
should be covered by MTA with the third party.
3. Depositor’s Rights
1. The Depositor retains ownership over all samples and clinical data provided by them.
2. The Depositor reserves the right to refuse permission for use of their samples by other studies.
3. The options for those who withdraw from the RKD Biobank are:
a. To donate their holdings to the Biobank
b. Arrange for transport to another suitable facility
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4. The Biobank’s Responsibilities:
1. The Biobank will ensure controlled and monitored storage of all samples within the Biobank at the
appropriate temperature
2. The BioBank will provide, if requested, a report of the temperature at which samples have been
stored since check in at the facility
3. The BioBank will comply with requirements of the appropriate local ethics committees.
5. The BioBank will comply with requirements of The Data Protection Act 1988 & 2003 (Ireland) and the
Data Protection Guidelines on research in the Health Sector published by the Data Protection
Commissioner
6. The BioBank will provide for reception of samples between 08.00-16:00 Monday to Friday, unless
specific alternative arrangements and procedures have been arranged
7. The BioBank will provide an electronic copy of the status of banked samples upon request
8. The BioBank will, if requested by the Depositor, arrange cold transfer of samples to collaborators,
the cost of which will be borne by the Depositor.
5. Biobank’s Rights
1. To raise invoices as agreed in Section 8
2. To release holdings to the depositor in the event of non-payment of fees or excess duration of
agreed storage period. NB: Release of tissue must be to another appropriate Biobank or to an
ethically approved research project
3. The Biobank retains the right to assume ownership of samples or remove samples to an appropriate
facility if the user consistently fails to pay fees
4. The BioBank has been set up as a national resource with funding secured until June 2017; deposited
samples will be maintained free of charge while this funding is in place. If funding is withdrawn, the
BioBank will operate a self-sustaining funding structure which will entail costs being passed on to the
Depositor. If the Depositor does not wish to continue on this basis, the holdings will be released to
them
5. To provide publically accessible information on the holdings in the BioBank via the RKD website. This
will be restricted to the Sub bank title, a description of what type of samples are held and an
indication of the number of cases recruited. The Depositor may, if they wish, remain anonymous.
6. Rules of Access to samples
1. Access to samples will be via a 1-page form detailing the nature of the study and ethical framework
2. Access will be free to the Depositor of the samples. A charge will be levied if external users wish to
access the samples for other studies.
3. A nominated point of contact from the RKD steering committee will manage the interaction between
the Biobank and any external user. This person may be linked to the project by virtue of having a
history of successful collaboration with the external investigators, or because of a link with the
particular organ system under study.
4. An MTA will be required if samples or clinical data are to be released to external collaborators.
7. Rules of authorship and publication
1. Authorship will be decided where possible in principle a priori and on a rotating basis by the steering
committee. The point of contact will have final responsibility for defining authorship. Proposed
authors include:
a. Nominated point of contact (as defined above),
b. The person running/initiating the study and
c. One other contributing member of the RKD steering committee (on a rotating basis).
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2. In addition, individuals who have contributed to data and/or samples used in the project will be
invited to be part of the project, and therefore authors.
3. Authorship will require active participation: study design, data management, statistical analyses, or
finalizing/writing/reviewing the manuscript.
4. ‘on behalf of the RKD registry and Biobank’ should be included in the authorship
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8. Details of proposed RKD sub-bank
Title:
Funding Status:
A) Please provide a one-paragraph summary of the study rationale and aims:
B)





Ethics Status of study
Ethics approved
Awaited
Wish to use RKD ethics
Not needed, please explain reasons:
If RKD ethics not used, please state source of ethical approval
(Please forward copy of ethical approval)
C) Collection site of samples:
D) Delivery details:
Researcher to arrange delivery - Courier
Researcher to arrange delivery - Post
Researcher to deliver sample by hand
Biobank to collect samples via RKD registry nurse infrastructure
Samples to be collected via CRF
Other, please specify below
E) Details of Contact arrangements and responsibilities for collection of samples
 RESPONSIBILITY FOR SAMPLE LIES WITH THE DEPOSITOR UNTIL IT IS COLLECTED / RECEIVED BY THE
BIOBANK
Contact details:
Investigator is responsible for (please tick all that apply):
Provision of sample collection packs
Patient sample detail form
Patient data collection form
Entry of clinical dataset into database
Collection of samples
Processing of samples
Transport of samples to BioBank
BioBank is responsible for (please tick all that apply):
Provision of sample collection packs and barcode labelling kits
Patient sample detail form
Patient data collection form
Collection of samples at RKD Clinic
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Processing of samples
Training in sample processing
Transport of samples to BioBank
Booking samples in to BioBank
Storing and maintaining samples in the Biobank
F) Linked clinical datasets
The Biobank can provide access to an online clinical phenotyping database which allows recording of
clinical variables that will be linked to the samples held in the Biobank. We strongly recommend this
approach as it holds the data in a robust anonymised secure format that ensures permanent linkage with
samples.
Do you wish to avail of this option? Yes
If yes:
Please provide email addresses of those requiring access to the database:
If no:
Do you agree to provide an anonymised linked clinical dataset for each sample, to include (at a
minimum) DOB, gender, affected/unaffected, relationship to index case, degree of renal dysfunction?
Yes
G) Type of samples and processing required
Sample type (Please tick)
Whole blood for DNA extraction
Saliva for DNA extraction
Cells (please specify below)
RNA paxgene tube
Plasma (proteomics grade)
Plasma (non-proteomics grade)
Urine (proteomics grade)
Urine (non-proteomics grade)
Serum
Tissue (please specify below)
Other (please specify below)
Other samples:
H) Sample processing:
_______
I)
Do you wish the Biobank to arrange DNA extraction? The charge is between €10 and €15 per sample,
which will be invoiced directly to the investigator.
_______
J) Number of recruits anticipated
K) Expected frequency of recruits (eg: how many per month?)
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L) Start Date of study
M) Expected date of last recruit
N) Storage of samples beyond 3 years (this will incur a charge of €5/aliquot/year)?
_________.
O) Details of Sample transfer to collaborator
 RESPONSIBILITY FOR SAMPLE LIES WITH THE BIOBANK UNTIL IT IS FORMALLY RELEASED TO THE
RESEARCHER
Are you willing to bear the cost of sample transfer to collaborators?
_________.
Do you wish BioBank to arrange sample transfer to collaborators?
_________.
P) Additional comments
Service Level Agreement: RKD BioBank
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Dated:
.
Signed on behalf of the Rare Kidney Disease BioBank:
X
Signed on behalf of the Depositor:
X
Service Level Agreement: RKD BioBank
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