How BASICS uses personal data
Thank you for your participation in the
BASICS Trial.
You
might recall that before taking part in the BASICS clinical
trial you were asked to read the information sheet and gave
your consent for your data on NHS hospital admissions to be
collected from electronic routine NHS health care records.
The aim of this notice is to give you further information on
how the data collection process works.
One of the purposes of BASICS is to
assess the value for money of antibiotic and silver
impregnated shunts compared to standard shunts. To do that
we will need to collect information about your hospital
admissions and other uses of the NHS. This can be done by
accessing information about you which is stored on NHS
computer systems. The purpose of this notice is to explain
this in more detail, and to ensure that you are fully aware
of how your data will be collected, securely transferred and
analysed.
Information
about your attendance to hospitals is recorded on NHS
computers. This forms your electronic medical record. These
records are stored securely and shared between a number of
NHS organisations to inform your care and the wider
functions of the NHS. In BASICS, we will use data from your
electronic medical records alongside information from the
questionnaires you fill in.
For Patients
in England
We will access information from your electronic
medical records about your hospital care (these are called
Hospital Episode Statistics) and other uses of the NHS from
NHS Digital (https://digital.nhs.uk/
). NHS Digital is the organisation which collects this
information on behalf of the NHS. We will ask NHS Digital
for Hospital Episode Statistics on your outpatient,
inpatient and A&E attendances for the period covering the
financial years spanning the BASICS study.
To retrieve
information from your electronic medical records,
information to identify you, namely your name, date of
birth, NHS Number, gender and postcode will be securely
transferred from the BASICS study team at the University of
Liverpool to NHS Digital. Information about your hospital
care will be securely transferred from NHS Digital to the
University of Liverpool and to the BASICS health economists
at Bangor University.
For Patients
in Wales
NHS Wales
Informatics Service already holds the required data
regarding your hospital admissions. In order for this data
to be used, it is a requirement that a copy of your consent
form is securely and confidentially transferred to NHS Wales
Informatics Services for confirmation of consent.
The “Consent
for the Transfer of Consent Form to NHS Wales Informatics
Services” form provides you the opportunity to give your
permission for us to send your consent form to NHS Wales
Informatics Service. This will be reviewed by the
Information Governance Department at NHS Wales.
To retrieve
information from your electronic medical records,
information to identify you, namely your name, date of
birth, NHS Number, gender and postcode will be securely
transferred from the BASICS study team at the University of
Liverpool to NHS Wales Informatics Service. Information
about your hospital care will be securely transferred from
NHS Wales Informatics Service to the University of Liverpool
and to the BASICS health economists at Bangor University.
For All
Patients
We will
extract information only once. We will obtain information
only from the 26th March
2013 to the 30th April 2018, which is the timeframe that
covers the duration of the study.
Your
electronic medical records will be stored on secure
University of Liverpool and Bangor University computer
servers which meet NHS data security standards.
The BASICS
study team at the University of Liverpool will receive the
electronic medical records and then link all the information
collected about you for the BASICS study. The BASICS study
team at the University of Liverpool will remove your
identifying details before sharing the information with the
members of the study team at Bangor University who will be
conducting the analysis.
Data
protection and security is of paramount importance and all
information collected about you during this study will be
used in accordance with the Data Protection Act 1998 and the
General Data Protection Regulation (GDPR) which will come
into effect from 25/05/18. Personally identifiable
information collected for this study will be deleted at the
end of the trial archiving period, which is for a maximum of
15 years from the official End of Trial.
All of the
organisations involved in this study have established
systems in place for securely retrieving and transferring
information from electronic medical records for research.
We would
like to remind you that your participation in the BASICS
clinical trial is voluntary and you can withdraw from the
trial at any time by revoking your informed consent, without
giving a reason and without incurring any adverse effect on
the level of care you will receive.
If you have
any questions please contact the BASICS study team using the
contact details provided below.
Tom Kearns (BASICS Trial Co-ordinator)
Telephone: 0151 795 8759
Email:
basics@liverpool.ac.uk
