Psycymru-wales psychosis cohort
Research type
Research Tissue Bank
IRAS ID
161615
Contact name
Keith Lloyd
Contact email
Research summary
PsyCymru - Wales Psychosis Cohort
REC name
Wales REC 3
REC reference
14/WA/1136
Date of REC Opinion
12 Sep 2014
REC opinion
Favourable Opinion
Data collection arrangements
The feasibility phase of the PsyCymru project ends on 22/10/14 (REC ref 09/MRE09/52), which involved direct
recruitment of participants from healthcare and other settings, the collection of data and the taking of blood samples for
genetic testing during the face to face interviews. No further direct recruitment from health care settings is planned for
PsyCymru. We wish to renew the PsyCymru research tissue bank to keep our existing collected data and samples
and also to expand the tissue bank by being able to receive donations of clinical data and DNA genotyping and
sequencing results from other ethically approved psychosis studies in Wales (from participants who have given theirpermission to share their data with us).
1) EXISTING DATA STORED IN PSYCMYRU RESEARCH TISSUE BANK FOR RESEARCH PURPOSES:
Genetic data: Study ID and sequencing and genotyping results in password protected/encrypted databases stored on
password protected computers in the secure lab facilities at the two sites (Cardiff and Swansea Univesities) and are
shared with the Principal Investigator (PIs) and authorized personnel of the study team. In linked anonymised format,
with study ID, containing no person identifiable data.
Clinical Data: Completed paper questionnaire results from semistructured
interviews. The questionnaires were
well validated neuropsychiatric assessment scales: the Schedule for Assessment in Neuropsychiatry, (SCAN), the
Scale for the Assessment of Positive Symptoms/the Scale for the Assessment of Negative Symptoms (SAPS/SANS),
Positive and Negative Symptom Scale Rating PANSS), the Hamilton Rating Scale for Depression (HAMD), the National
adult reading test (NART), selfreport
mood ratings (Beck Depression Scale & Altman Mania) questionnaires. In
addition to clinical symptoms, data relating to social circumstances, family history, medical history, childhood
development and the development of their medical problems are also stored. Medical records have previously been
accessed to supplement the above information.
Shortened electronic version of above. We extracted the most important information from the abovementioned
completed questionnaires to create electronic versions of the clinical data ready for analysis and for importing into the
Secure Anonymised Information Linkage (SAIL) Databank to link to the longitudinal routine datasets therein. Details of
SAIL were provided in the feasibility phase of PsyCymru (REC ref 09/MRE09/52).
Personal data An
electronic Contacts Database holding participants' personal details and the study identifier
numbers will be held at each site.
Paper consent forms.
How is data stored: Data is stored in linked anonymised electronic format All
participants have a unique study
identifier number, which enables linkage of the clinical and personal data. All data and DNA samples, DNA
genotyping and sequencing results will be identified by these ID numbers. Personal data and clinical data are stored
separately and securely, ensuring confidentiality. The databases are held on appropriate storage devices which are
password protected/encrypted and only accessed by restricted personnel involved in the study.
The completed paper questionnaires and the paper consent forms are stored in locked cupboards, access to only
authorised personnel at both sites. They are stored separately from one another.
Electronic data is stored in password protected databases, personal and clinical data held separately.
2) DATA RECEIVED AS DONATIONS FROM OTHER ETHICALLY APPROVED PSYCHOSIS PROJECTS AND STORED
IN PSYCMYRU RESEARCH TISSUE BANK FOR RESEARCH PURPOSES:
DATA COLLECTION PROCEDURE donations
from other studies:
The clinical and genetic (dna sequencing) results from persons already enrolled on other ethically approved
psychosis studies (run by the Department of Psychological Medicine at Cardiff University) who have indicated their
willingness to share their data (via their Consent form) will be forwarded securely (by secure transfer mechanisms) in
encrypted and password protected electronic form to the PsyCymru research database in either Swansea or Cardiff
Universities, where it will then be saved on encrypted/password protected databases in linked anonymised format and
only accessed by restricted personnel involved in the study. All participants have a unique study identifier number,
which enables linkage of the clinical and personal data.
The data stored and storage mechanisms would be exactly the same as for the existing data detailed above.
LINKAGE OF CLINICAL AND DNA SEQUENCING DATA TO ROUTINELY COLLECTED DATA HOUSED IN THE
SECURE ANONYMISED INFORMATION LINKAGE (SAIL) DATABASE; fully anonymised format
All consented individuals will also have their clinical and DNA sequencing results imported into SAIL in fully
anonymised format. The data held in sail, including imported data from research studies is in fully anonymised
fomat. Import and linkage to the datasets held in SAIL allows us to study patient outcomes and to answer future
research questions about psychosis and to create an anonymised electronic cohort of all persons with psychosis in
Wales using the routinely collected data in SAIL to greatly enhance the size of our sample and allow us to follow up
large anonymous cohorts in addition to the well characterised smaller sample of consented individuals. The study
data will be loaded onto the SAIL databank according to the file transfer regulations/HIRUs Data Scoping protocol that
ensures safe electronic data transfer of datasets onto SAIL. The method involves a split file approach, whereby the file
containing the patient identifiable data will be sent to NWIS and the clinical data will be sent to HIRU, both only linked
by a system ID. NWIS would validate the NHS numbers and then attach an Anonymous Linking Field (ALF) by secure
encryption, along with a geocode (geographical area) and then strip the file of demographics and send to HIRU. HIRUwould join the file to the clinical data file. Further confidentiality checks (i.e. check for rare conditions) would be
undertaken by HIRU and then the ALF would be encrypted again into the ALF_E, which would become the final data
file. This approach has been in place for over a number of years now and is well tested and is subject to a number of
checks and safeguards. The procedures for preserving anonymity in the SAIL project, conform to the Health
Informatics Research Unit (HIRU) Data Anonymisation Policy and Process (DAPP) document, which takes account of
the Data Protection Act (1998), the principles of the Caldicott report (1997) and measures that embody good
information governance. The DAPP has been endorsed by Informing Healthcare and the Corporate Health Information
Programme (CHIP) and has been reviewed by Caldicott Guardians and Information Governance Officers in the NHS
and Local Government. HIRU has an independent Information Governance Review Panel (IGRP)which judges whether
proposals are in the public interest. This panel contains members from National Research Ethics Service, Involving
People, Informing Healthcare, the British Medical Association and the National Public Health Service for Wales.
All aspects of this study will be subject to the relevant research governance, good clinical practice and ethical
frameworksResearch programme
PSYCHOSIS RESEARCH The research will be of a basic, translational nature in the field of experimental medicine in psychiatry. For example, research questions about gene/environment interaction, causal pathways, disease mechanisms and treatment response in psychosis. No research will be conducted relating to the testing or safety of cosmetics or other consumer products (i.e. not related to healthcare).
RTBTitle
PsyCymru - Wales Psychosis Cohort
Establishment organisation
Swansea University
Establishment organisation address
Institute of Life Science 2
College of Medicine
Swansea
SA2 8PP