RITA-Ireland Vasculitis RIV Registry and Biobank
The RKD Registry and Biobank was established in 2012 to address an unmet need in the study of rare kidney disease in Ireland: facilitation of clinical studies when sporadic cases are scattered throughout many hospitals in Ireland. Existing centre-based research facilities had served this need poorly, and a networked collaboration across all the CRFs in the country provided vastly improved potential for the capture of presentations nationally. The majority of recruits have the rare disease ANCA vasculitis. In 2022, the RKD Registry and Biobank was renamed the RITA-Ireland Vasculitis (RIV) Registry and Biobank after joining ERN-RITA.
RITA-Ireland Vasculitis (RIV) Registry and Biobank Protocols
Guide to using the RKD Registry hosted in REDCAP
1. Introduction to data entry
2. Creating a new RKD ID
3. Initial data entry for new RKD recruits
4. Site review OR clinic entry
These videos were created by Dr Jennifer Scott
Data export from redcap database
EUVAS Data Dictionary
Sample Processing Sheet
Trinity Kidney Centre Ethics Documents
- St. James's and Tallaght University Hospital Recruitment Documentation
- Beaumont Hospital Recruitment Documentation
- Cork Teaching Hospitals Recruitment Documentation
- Mater Hospital Recruitment Documentation
- St. Vincents Recruitment Documention
- Limerick Hospital Recruitment Documentation
- Galway Hospital Recruitment Documentation
Data privacy notice and data management plan
The purpose of this Privacy Notice is to explain to you, our participants, how we collect share and use the personal information about you which forms the RIV Registry and Biobank resource. We are required to provide the information set out below in accordance with the Irish Health Research Regulations.
Fundamentally, we should like to assure you that we will only process, store and use your data in a manner that is consistent with the basis on which you joined the RIV Registry and Biobank (as described in the information leaflet and consent form). This Privacy Notice sets out the types of data we have collected from you and how and by whom that data is used. It also sets out the lawful basis on which we process your data, your rights as a data subject and your rights to withdraw from the RIV Registry and Biobank.
We would also emphasise that wherever possible your data is de-identified such that direct and indirect identifiers are removed. We only use identifiable data where necessary: for example when we contact you with a participant newsletter or to advise you about a clinical trial we feel may be of interest to you.
The types of data the RIV Registry and Biobank processes
What personal information does RKD Biobank collect?
The RIV Registry and Biobank collects personal information about you from two sources (1) directly from you and (2) through linkage to your health records. These are explained in more detail below:
Data collected directly from you
When you were recruited to join the RIV Registry and Biobank you will have visited an the RIV Registry and Biobank research clinic and provided some data about yourself - this will have included measures such as your weight, height and biological samples such as blood and urine. Any identifiable data obtained at recruitment is held separately on a separate log to which only the relevant research nurse and site investigator have access.
Following the original recruitment The RIV Registry and Biobank has continued to collect more data on a periodic basis, such as:
- data collected when participants attend a study clinic or hospital
- data collected through participants completing online questionnaires
- data collected from assays performed on the samples you provided
With the data and samples that you provide us we can generate further data to enhance our database, particularly from undertaking assays of the samples. This includes, by way of example, biomarkers - which include common biomarkers, such as cholesterol, infectious disease markers, proteomic and metabolomic markers - and genetic data (ranging from genotype to exome sequence to whole genome sequence). All assay work is conducted in a manner whereby the participant remains de-identified.
Further, all our approved researchers are also obliged to return the results which underpin their research at the end of their research project. In turn these results are made available for other researchers to access.
Who does RKD Biobank share my data with?
Access to your data is strictly limited to:
- the study site/hospital where you are seen for your clinical care;
- Approved researchers whose research project has been approved under our Access Procedures, which means that the researcher has to be a bona fide researcher and enter into a bilateral agreement with TCD. If you would like more information about the approved research projects which have access to RIV Registry and Biobank data, please click the link below.
The RIV Registry and Biobank’s lawful basis for processing your data
A legal requirement of the RIV Registry and Biobank is that we tell you about the legal basis on which we will process your personal data.
As the RIV Registry and Biobank is a research project, consent was sought from all participants for their participation. Through the information leaflet and consent form the RIV Registry and Biobank set out to explain the basis of such participation and a summary of the scope to which participant data would be used by the RIV Registry and Biobank and the research community.
The legal basis under which we process your data is:
- Article 6(1)(e) - Public Interest and
- Article 9(2)(j) Scientific Research.
Explicit consent is sought as an appropriate safeguard to rights of the data subject as mandated by the Health Research Regulations.
Your Data Protection Rights
Pursuant to the Health Research Regulations individuals have a number of rights:
Rights to be forgotten, erasure and withdrawal: these rights are covered by your ability to withdraw from the RIV Registry and Biobank at any time for any reason (although we should add that we very much hope that you choose not to exercise that right so that your data can continue to be used to help researchers study the causes, prevention and treatment of many different diseases).
Participants have the right to contact, at any time, the RIV’s data protection authority – the Irish Data Protection Commission - if they have any concerns about the RIV Registry and Biobank’s use of personal data and/or the RIV Registry and Biobank’s approach to data protection and the Health Research Regulations.
Protecting your data
The RIV Registry and Biobank and its appointed data processors store your data securely and to the highest industry and professional standards. Before the RIV Registry and Biobank provides data to researchers, we first remove all the personal identifiers so that individual participants cannot easily be identified. In addition, your data are only provided to researchers on the execution of a legal agreement prohibiting the researcher from trying to identify a participant.
Only a very limited number of people working in the RIV Registry and Biobank centres have access to participants’ data with the personal identifiers (which is necessary in order to allow us to interact with you and add more information about each participant as it becomes available). These individuals are subject to strict confidentiality provisions and are required to undertake regular data security training.
Retention of data
The RIV Registry and Biobank will store participants’ data for as long as it has a legitimate interest in doing so. The RIV Registry and Biobank project is a long-term study and participants’ data will be kept for the duration of the project. However, should a participant wish to leave the RIV Registry and Biobank they can do so at any time.
International Data Transfers and industry engagement
Our objective is to set up and manage a major research resource for health-related research that is in the public interest. We aim to understand the causes of rare autoimmune diseases, develop precision medicine technologies, and provide the foundation for development of novel therapies. Engagement with international collaborators is an essential part of this journey; sometimes these collaborators are in the non-academic (industry) domain. Our engagement with them is always defined using a formal bilateral agreement that determines what they are allowed to do with the samples and data, ensuring that they are used to further the public interest mission of the RIV Registry and Biobank. The RIV Registry and Biobank’s main computer storage is located in Trinity College. Approved researchers and the RIV Registry and Biobank’s other third-party service providers operate around the world. This means that your data may be processed in these countries. Nevertheless, we take the appropriate safeguards to ensure that your personal information will remain protected in accordance with this Privacy Notice. Such safeguards include mechanisms approved by the Health Research Regulations such as Standard Contractual Clauses and data transfers to countries covered by an “adequacy decision”.
Data Protection Officer
Trinity College has a research Data Protection Officer ("DPO") who can be contacted with any questions or concerns relating to the RIV Registry and Biobank’s approach to data protection and the Health Research Regulations. Please write to the DPO using researchDPO@tcd.ie or via post: Trinity College Dublin, College Green, Dublin D02 PN40.
Withdrawal from RKD Biobank
You are free to withdraw at any time from the study without giving us a reason. You are welcome to discuss concerns with us at any time, and the various options you have for withdrawal.
Participants can withdraw at one of two levels:
No further access
This means that the RIV Registry and Biobank would no longer contact the participant or obtain further information from health records in the future, but still has permission to use the information and samples provided previously. You need to contact the RIV Registry and Biobank by phoning 01 896 4810, email us at email@example.com, or you can send us a letter at the address on this page to request a Withdrawal Form.
No further use
In addition to no longer contacting the participant or obtaining further information, any information and samples collected previously would no longer be available to researchers. The RIV Registry and Biobank would destroy samples (although it may not be possible to trace all distributed sample remnants) and would only hold information for archival audit purposes. Such a withdrawal would prevent information about the participant from contributing to further research, but it would not be possible to remove data from research that had already taken place. You need to contact the RIV Registry and Biobank by phoning 01 896 4810, email us at firstname.lastname@example.org, or you can send us a letter at the address on this page to request a Withdrawal Form.
The RIV Registry and Biobank contact details
If you want to contact the RIV Registry and Biobank you can do so as follows:
Phone: +353 1 896 4810
You can write to the RIV Registry and Biobank at:
The RITA-Ireland Vasculitis (RIV) Registry and Biobank:
Trinity Kidney Centre,
Trinity Translational Medicine Institute,
St James’ Hospital,
You can also contact the RIV Registry and Biobank DPO at any time using the contact details set out in the DPO box above.
- RKD-Newsletter-Spring-2022 (PDF 1.18MB)
- RKD-Newsletter-Spring-2021 (PDF 969kB)
- RKD-Newsletter-Spring-2020 (PDF 335 kB)
- RKD-Newsletter-Spring-2019 (PDF 897 kB)
- RKD-Newsletter-Spring-2018 (PDF 567 kB)
- RKD Newsletter Spring 2017 (PDF 1.32 MB)
- RKD Newsletter Spring 2016 (PDF 1.09 MB)
- RKD Newsletter May 2015 (PDF 1.5 MB)
- RKD Newsletter June 2014 (PDF 1.2 MB)
- RKD Newsletter January 2013 (PDF 1.09 MB)
- Alterations in circulating lymphoid cell populations in systemic small vessel vasculitis are non specific manifestations of renal injury (Fazekas et al, 2018) (PDF 611kB)
- ANCA and Anti GMB Double Positivity A Case Series (Kelly et al, 2015) (PDF 31kB
- Anti myeloperoxidase antibodies attenuate the monocyte response to LPS and shape macrophage development (Popat, et al 2017) (PDF 1,981kB)
- Changes in urinary metabolomic profile during relapsing renal vasculitis (Al Ani et al, 2016) (PDF 1,530Kb)
- Clinical heterogeneity in Familial IgA Nephropathy (Fennelly et al, 2018) (PDF 159 kB)
- Intermediate monocytes in ANCA vasculitis increased surface expression of ANCA autoantigens and IL1 beta secretion in response to anti MPO antibodies (O Brien et al, 2015) (PDF 1,415 kB)
- Prolonged Duration of Renal Recovery Following ANCA Associated Glomerulonephritis (Oomatia et al, 2016) (PDF 132 kb)
- The Irish Kidney Gene Project Prevalence of Family History in Patients with Kidney Disease in Ireland (Connaughton et al, 2015) (PDF 250 kB)
- Urinary and serum soluble CD25 complements urinary soluble CD163 to detect active renal anti-neutrophil cytoplasmic autoantibody associated vasculitis, a cohort study (Dekkema et al, 2018) (PDF 443 kB
We welcome expressions of interest from potential collaborators, please email us at email@example.com.
Number of recruits to RIV Registry Biobank since inception; many have multiple longitudinal samples at different stages of the disease
Biological samples (serum, proteomic grade plasma, urine, leucocytes, RNA and DNA) are processed and stored centrally in the Trinity Translational Medicine Institute in temperature monitored freezers, with archiving managed using industry standard Freezerworks software. All aliquots are bar coded and mapped to the freezer location. Linked clinical data are recorded by local clinician and research nurse on a web-accessed database on the REDCap platform developed and managed by Trinity Research IT. Every aliquot has a clearly documented provenance.
The facility is managed by Dr Alan Kennedy. For further information, or to inquire about potential projects or collaborations, please contact; firstname.lastname@example.org or +353 1 896 4810
Postal AddressRITA-Ireland RIV Registry and Biobank,
Trinity Health Kidney Centre,
Trinity Translational Medicine Institute,
St James’ Hospital,