The Rare Kidney Disease
Registry Biobank
Information on the Rare Kidney Disease Registry Biobank
Abbreviations:
Trinity College Dublin
Standard Operating Procedures
Service Level Agreement
Rare Kidney Disease
TCD
SOP
SLA
RKD
Description of BioBank
The Rare Kidney Disease Registry BioBank presents a unique opportunity to advance medical
research through making access to human samples easier, ethically robust and more efficient. The
BioBank is:
 A highly flexible facility
 Directed at the user to:
1. Facilitate research
2. Improve research governance
3. Enhance availability of TCD Rare Kidney Disease Registry Biobank holdings
to researchers within TCD, Nationally and Internationally.
 Provide assistance with regulatory compliance
 Provide assistance with sample processing/training/advice
 Provide necessary consumables such as, barcoded labels, sample collection kits/processing
kits/data collection forms.
 Enable the deposits to remain the property of the Depositor/User
The Biobank provides a flexible approach to banking and allow the user to pick and choose the services
they require to fit their requirements. Collaborations arising from publicising of the holdings are entirely
at the discretion of the depositor.
Why is there a biobank?
In Ireland, all research planned on human samples requires ethical approval. All of this paperwork is
in addition to writing the research protocol and obtaining research funding.
Our ethical approval for collection of samples for studies into Rare Kidney Disease at major hospital
sites throughout Ireland enables us to act as a resource for clinicians who wish to study these
diseases. We can use this infrastructure to collect standardised samples and data for this purpose,
thus reducing the time required for the researcher to commence their research.
If the clinician has already obtained separate study specific ethical approval, we are also able to
provide infrastructure to aid in the collection and storage of samples and data. We have highly
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qualified staff and advisors who can assist the clinician with their choice of sample and procedures
for sample collection processing transport and storage.
If cohort recruitment is managed through a DCCR-supported RKD research clinic, we can provide
research nurse support for consenting and sample acquisition, plus sample processing and archiving on
site, with subsequent long term archiving in the biobank in TCD. We can also assist with sample transfer
to other sites (costs for such shipment will be borne by your group).
If cohort recruitment is handled outside these clinics, we can provide sample archiving support from the
point of sample arrival at the TCD biobank, along with assistance with shipment as above.
We are also linked to the DNA isolation facility at TCD Biobank, providing seamless DNA preparation.
Advantages of the Rare Kidney Disease Registry BioBank
1. Depositors will remain the “owner” of the tissues which they deposit (either physically or
“virtually”). Other large tissue banks offer to hold tissues but also establish ownership. Thus
researchers and clinicians who have gone to the trouble of obtaining clinical samples for research
will not lose control of them.
2. If requested, the paperwork required for depositing samples will be undertaken by the BioBank.
The samples within the BioBank will be available for high quality, ethically-approved research
projects. In addition, we envisage that the BioBank will provide in the long term logistical support to
more conventional clinical trials and the capacity to store trial samples for additional or future
testing.
What samples can be banked?
The BioBank is designed to support research into rare kidney disease, i.e.: diseases with a
prevalence of <5/10,000. It acts as a physical repository for whole blood, cells, plasma, serum, DNA,
RNA, renal tissue and urine. We can offer free aliquot storage for up to 3 years, after which we will
return the samples or maintain them in the Biobank for a small charge.
Description of sample and data management – Gold Standard Freezerworks Software
In order to manage the complex IT systems underlying biobanking such as repository management,
patient sample information and research analytical laboratory management, the RKD Registry and
Biobank uses Freezerworks Unlimited Software (Dataworks Inc.). This software is both configurable
and secure, with focus on freezer inventory, sample labelling, tracking, and management for
biorepositories. It enables barcode labelling and tracking of samples.
For data collection and interrogation requirements the RKD Registry uses a web based database
(configured in Distiller) which allows online data entry at any location. This has been developed by
John Mc Court (RCSI) and his team and has previously been used in Ireland by successful biobanking
projects such as the Irish Prostate Cancer Consortium project.
If required for the study, patient-specific identifiers will be removed and held on a separate
database. The only linkage will be a 6 character barcode which will be part of both databases.
The RKD database will be web-accessible so that researchers from around the world will be able to
identify sample holdings and thus initiate collaborative research.
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Rare Kidney Disease Registry Biobank–Requirements of proposed
sub-bank
Suggested Sub-Bank name:
Main contact details:
Name:
Address:
Phone:
Email:
Please provide a one-paragraph summary of the study rationale and aims:
Ethics Status of study
Ethics granted
Awaited
Wish to use RKD ethics
Not needed, please explain reasons:
Funding status
Funded
Awaiting funding
No funding required
Sample collection site:
Tallaght RKD registry clinic
Beaumont RKD registry clinic
Other clinic, please list below
_______________________________________
Delivery to Biobank:
Type of samples and Processing details:
Sample type (Please tick)
Whole blood for DNA extraction
Saliva for DNA extraction
Cells (please specify below)
RNA paxgene tube
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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: _________________________________________________
Sample processing:
By BioBank / Research nurse
By Researcher (training required)
By Researcher (no training required)
Study size (no of subjects):
Start date for study:
Sample destination:
Additional comments
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Transfer all samples to collaborator
Archive in Biobank requested