BCIS / NICOR data sharing agreement April 2010

BCIS / NICOR data sharing agreement,
April 2010
1. Scope....................................................................................................................................1
2. Background..........................................................................................................................1
3. Application process ............................................................................................................3
3.1 Informal contact...............................................................................................................3
3.2 Project proposal ...............................................................................................................3
3.3 Funding ............................................................................................................................3
3.4 Evaluation of the proposal ...............................................................................................3
3.5 Dataset release .................................................................................................................4
3.6 Appeal process.................................................................................................................4
4. Terms and conditions for use of BCIS data....................................................................4
4.1 Use of data .......................................................................................................................4
4.2 Ethics and confidentiality ................................................................................................5
4.3 Security ............................................................................................................................5
4.4 Breaches in security .........................................................................................................6
4.5 On completion of research project...................................................................................6
4.6 Publications......................................................................................................................6
4.7 Accountability..................................................................................................................7
BCIS / NICOR Data Application Form .................................................................................8
BCIS / NICOR Data User’s Agreement ............................................................................11
Checklist for applicants ........................................................................................................13
1. Scope
This document explains the application process for researchers who wish to access
data from the British Cardiovascular Intervention Society data collected under the
auspices of the Central Cardiac Audit Database. It defines the terms and conditions
that must be agreed before data can be released, to ensure data security and due
sensitivity for identification of individual patients and hospitals.
2. Background
The British Cardiovascular Intervention Society (BCIS) has run a database project
since 1994. More recently the BCIS has set up the Data Monitoring and Analysis
Group to steer issues related to the BCIS database. The BCIS data is collected in
each individual hospital and transmitted to the central cardiac audit database
(CCAD), which is in turn part of the NHS information centre. To develop outputs from
the BCIS data, BCIS is working with the National Institute for Clinical Outcomes
Research (NICOR) at University College London. BCIS encourages applications for
research projects based on the BCIS data, but because of issues about the legal
basis of this type of data and to ensure the reputation of the BCIS and NICOR, this
document describes the process required for data to be shared.

The Patient Information Advisory Group (PIAG) 1 has granted NCASP Section 60
exemption of the Health and Social Care Act 2001 2 for all the cardiac audits,
including the BCIS audit. Section 60 permits the common law duty of confidentiality
to be lifted for activities that fall within defined medical purposes where anonymised
information will not suffice and consent is not practicable. Section 60 of the Health
and Social Care Act 2001 has been superseded by Section 252 of the NHS Act 2006
and the National Information Governance Board for Health and Social Care (NIGB) 3
for England and has replaced PIAG as the statutory body with responsibility for
Section 251 of the NHS Act 2006.
Under the Data Protection Act effectively anonymised data are not regarded as
personal data and therefore may be used for research without consent. There is,
however, no legal definition of anonymised data. The Act establishes a definition of
‘personal data’ as ‘data which relate to a living individual who can be identified (a)
from those data, or (b) from those data and other information which is in the
possession of, or is likely to come into the possession of, the data controller, and
includes any expression of opinion about the individual and any indication of the
intentions of the data controller or any other person in respect of the individual’. The
Act was intended to ensure that personal data are appropriately protected, so uses a
very broad definition, including information which might potentially identify some
individual, even if no obvious mechanism exists.
Pseudonymised data (where the data is effectively anonymised, except for a coded
identifier, and where the recipient of the data does not have access to the coding
mechanism and so cannot identify the patient) is ‘personal data’ within the meaning
of the DPA98, but could be considered to be anonymised information in the hands of
the recipient. Pseudonymised data are also referred to as linked anonymised data.
Linked anonymised data are still regarded as personal data even if the person is not
identifiable to the ‘Recipient’ (researcher), because the person is still identifiable to
the original holder of the data. In practice, provided the data is effectively
pseudonymised (linked anonymised), then researchers are generally given access to
this data, subject to certain safeguards.
NICOR receives downloads of data from the CCAD servers which contain vital status
and date of death supplied by the Office of National Statistics. Although patients’
names, hospital case record number, NHS number and hospital codes are collected,
these data items are pseudonymised by CCAD to protect the rights of participants
and the confidentiality of their data, before the data are released to NICOR. Date of
birth is converted to age at admission to 1 decimal place and postcode of residence
converted to deprivation scores and eastings and northings. However date of death
and complete eastings and northings are potential patient identifiers which are not
pseudonymised. Use of these data items will have to be justified before they are
released.
The following sections describe the process that researchers that wish to access
BCIS data for research purposes must follow. It is closely aligned to the MINAP data
1 http://www.advisorybodies.doh.gov.uk/piag/
2 http://www.hmso.gov.uk/acts/acts2001/20010015.htm
3 http://www.nigb.nhs.uk/

sharing agreement (MINAP is also based at NICOR) and the HES User Guide 4 . The
BCIS Data Monitoring and Analysis Group and NICOR will consider applications for
access to the data from organisations such as recognised Universities, Research
Institutions and NHS Trusts carrying out heart or heart related research in the
European Economic Area, or individuals working for one of the above.
3. Application process
The BCIS Data Monitoring and Analysis Group and NICOR will consider applications
for access to the data from organisations as recognised universities, research
institutions and Hospital Trusts carrying out heart or heart related research world
wide provided they are working in collaboration with a similar UK organisation and
are part of a recognised scheme as the US Safe Harbour Agreement.
3.1 Informal contact
It is recommended that the researcher first contacts the BCIS Data Monitoring and
Analysis Group chair via email (peter.ludman@uhb.nhs.uk) to discuss informally the
feasibility of their proposed project.
3.2 Project proposal
3.2.1 BCIS Data Application Form
This can be found at the end of this document and must be submitted for initial
approval by the BCIS / NICOR.
3.2.2 Data requested
A precise list of data items and time period required for the project must be defined
in the BCIS Data Application Form. The BCIS dataset is available on the BCIS web
pages (www.bcis.org.uk). Further use of the data in other areas of interest will
require a new application to be submitted and approved by the BCIS.
3.3 Funding
If the grant application is partially or totally based on the use of BCIS data the
applicant should give details about the funding application.
If the researcher wishes to apply for funding once the application has been approved
and the grant application is based on, or contains references to BCIS data, the BCIS
/ NICOR must be informed about the funding application (organisation, when and by
whom).
The BCIS / NICOR recommends that £10K is included in research grant proposals
but a smaller charge could be negotiated for smaller studies.
3.4 Evaluation of the proposal
The completed application form should be sent to the BCIS Data Monitoring and
Analysis Group chair. Evaluation of the proposal will be made on and ad hoc basis
4 http://www.hesonline.nhs.uk/Ease/servlet/ContentServer?siteID=1937&categoryID=403

y the BCIS / NICOR. The applicants must also send their System Level Security
Policy (see section 3.3.1)
A member of the BCIS Data Monitoring and Analysis Group will be allocated to each
project. The applicant and the BCIS collaborator will be asked to sign, date and
return the BCIS / NICOR Data User’s Agreement which will be counter-signed by
the BCIS Data Monitoring and Analysis Group chairman.
3.5 Dataset release
Once all conditions requested by the BCIS / NICOR for approval have been
accepted in writing by the applicant and the BCIS / NICOR Data User’s Agreement
has been signed by both parties, the BCIS / NICOR will authorise the release of the
requested data.
NICOR will generate the requested dataset and associated documentation where
necessary. The dataset will be supplied in ASCII format appropriately delimited,
encrypted using AES 256 encryption and delivered via a drop box. The key will be
given separately. Technologies will change with time and so this method will be
monitored and reviewed constantly.
3.6 Appeal process
Reasons for refusal of an application could include lack of outputs from previous
projects totally or partially based on BCIS data or concerns about the quality of the
project.
Should an application be refused by the BCIS / NICOR, the applicant is welcome to
make the appropriate changes and submit a new application which would be
expected to be substantially different to the original one.
4. Terms and conditions for use of BCIS data
The confidentiality of the patients and contributing hospitals must not be
compromised by use of the BCIS data. The reputation of the funding body, the BCIS
/ NICOR team must not be inappropriately compromised through unethical,
premature or opportunistic data analysis and the subsequent production of scientific
outputs.
The terms and conditions for data sharing outlined here are, together with the rest of
the sections of this document, in line with the MRC data sharing policy and access
principles.
4.1 Use of data
4.1.1 Data must be used only in the manner stated and for the research purposes
specified. BCIS data, in whole or in part, cannot be processed, disseminated or
otherwise made available or used for any other purpose, and none of the data can
be distributed to third parties.

4.1.2 Analyses are allowed only accordingly to the protocol described in the
application; major changes will require a new application.
4.1.3 Data users will not have sole and exclusive access to their required set of
data. Therefore, the BCIS / NICOR cannot guarantee that the area of interest stated
in their application will be for the exclusive use of the data user.
4.1.4 Data users should notify the BCIS Data Monitoring and Analysis Group
chairman of any errors or inconsistencies discovered in the data.
4.1.5 Data users should offer their derived variables to enrich the BCIS database if
requested to do so by the BCIS / NICOR.
4.2 Ethics and confidentiality
4.2.1 All medical research using identifiable personal information, or using
anonymised data from the NHS which is not in the public domain, must be approved
by a Research Ethics Committee (REC). The BCIS / NICOR will expect to see a
copy of the REC approval (or an equivalent university or industry specific document).
4.2.2 Ethical approval from the data user’s local ethical committee is the
responsibility of the data user.
4.2.3 Once the project has been approved, datasets will be provided without
restrictions within the European Economic Area (EEA, which consists of the twenty
seven member states of the European Union together with Iceland, Liechtenstein,
Norway and the States of Guernsey) and internationally recognised schemes as the
US Safe Harbour Agreement.
4.2.4 BCIS data must not be transferred to a country or territory outside the
European Economic Area and internationally recognised schemes as the US Safe
Harbour Agreement.
4.2.5 Researchers must ensure that personal information is handled by healthcare
professionals or staff with an equivalent duty of confidentiality to that in a National
Health Service (NHS) contract (eg an honorary NHS contract or university contract of
employment).
4.2.6 It is virtually impossible to guarantee that an individual will never be identified,
given the nature of the data. It is therefore the responsibility of data users to ensure
that the participants’ identity is not disclosed under any circumstances.
4.2.7 Data users must consider the risk of identifying individuals in their analyses
prior to publication. ‘Small numbers' are considered from 1 to 5. Low-level analyses
are more likely to contain small numbers which might facilitate identification of
individual patients. A higher level of aggregation should be considered when
analyses produce less than 5 cases.
4.3 Security
4.3.1 A System Level Security Policy must be included with the application. It
should specify precisely how and where the BCIS dataset will be stored and used. It
should include who is responsible for the data security and what access controls,
network monitoring and screening, anti virus defences are in place (i.e, all the
information described in the relevant section above). It should also describe the
levels of training regarding data handling and security that will be given to all staff
involved.

4.3.2 Secure data access such as passwords, firewalls, etc., must be in place to
ensure that the data are kept secure. Ideally, data users should access the provided
dataset using a network drive set up by the organisation where they work, and avoid
keeping datasets on their own PC/laptop. This network drive should be accessible
through password control.
4.3.3 Data users working on the same project must not use memory sticks or send
files to each other as attachments in e-mails. Instead, they should use a shared drive
for transferring files.
4.3.4 The BCIS / NICOR requires a list of all individuals who would have access to
the data, the names of their employers in this context and their job titles in the BCIS /
NICOR Data User’s Agreement.
4.3.5 Data must always be stored in a secure repository as a computer file server.
This data can then be accessed directly from computer workstations within the same
secure environment of the recipients’ organisation. Copies of the data must not be
taken out of this secure environment, for working on a local personal computer or lap
top computer, or taken off site by any means unless the copy has had all potential
identifiers, including eastings and northings, removed. Data should be encrypted on
pen drives and lap tops if there is any possibility of identifying a patient. Data in a cell
that contains

4.6.2 If at any stage the research or any presentation / publication falls outside the
terms of this data sharing agreement, BCIS / NICOR reserve the right to contact any
journal or conference organisers involved in the presentation /publication of the data.
In addition the trust Chief executive and research governance lead will be notified of
any R&D governance issues that have been breached.
4.6.3 Data users must preserve the confidentiality of the data in outputs and
publications (see above). The BCIS / NICOR will require a copy of any paper prior to
publication to be satisfied that no personal identifiers are included in the results. The
BCIS / NICOR has the right to refuse to grant permission to publish information
arising from BCIS data on the grounds of data protection.
4.6.4 The scope of the project should be aimed at the publication of one or two
scientific articles within two years from the date when the requested dataset is
received by the data users. Users can subsequently submit new applications for data
if they wish to do further analyses.
4.6.5 The name of the BCIS must be included in the title or subtitle, and any
publication must include the sentence: “This study includes data collected by the
British Cardiovascular Intervention Society under the auspices of the Central Cardiac
Audit Database.”
4.6.6 Co-authorship is not required but if any member of the BCIS / NICOR has
provided significant input they should be included as an author.
4.7 Accountability
4.7.1 Overall accountability to funding bodies for research projects remains the
responsibility of the Principal Investigator.
4.7.2 The BCIS / NICOR should be updated on the progress of the project and
outputs should be submitted within two years from the date when the requested
dataset is received by the data users.
4.7.3 The Principal Investigator must prepare a summary of their main findings
when asked.
Please note that the BCIS / NICOR retains the right to modify the contents of
this document at any time.

BCIS / NICOR Data Application Form
1. PRINCIPAL INVESTIGATOR
Title, forename, surname: .
Employing organisation: .
Position in organisation: .
Address of organisation: .
.
.
Telephone: .
Email: .
Please attach the Principal Investigator’s Curriculum Vitae.
2. RESEARCH TEAM / CO-APPLICANTS
Details of each Research team member involved in the proposed project.
Research team
Employing
Position in
Contact details
members / Co-
organisation
organisation
(Email address/Telephone no)
applicants
3. PUBLICATIONS OF THE RESEARCH TEAM MEMBERS
List of the main publications of each Research team member involved in the project.

4. PREVIOUS APPLICATIONS
Have you or any of the Research team members/co-applicants applied for BCIS data
in the past?
If Yes, please give details:
Main
Applicant
Application Date Project Title Scientific Outputs
5. FUNDING
Do you already have funding to carry out this project
If you are planning to seek funding to carry out this project and the grant application is to be partially
or totally based in the use of BCIS data, please give details about the funding application.
Name of funding body
Dates
Applicants
Title of application
Synopsis of application (max 100 words)
6. RESEARCH PROJECT
6.1 PROJECT TITLE
6.2 SUMMARY
A brief summary of up to 200 words describing the aims of the study/research project
6.3 CONTEXT
Where research is part of a larger programme, please give details.
6.4 PROJECT DESCRIPTION

Full description of the purpose/s for which the data are requested (maximum 4 A4 sides excluding
references)
Background
Scientific hypothesis
Objectives
Methodology and planned statistical analyses
Competing interests
References (max 10)
6.5 PLANNED SCIENTIFIC OUTPUTS
Intended outputs/publications arising from the use of these data, including abstracts, posters and
research papers.
7. DATA REQUESTED
Data items required for analysis. Please refer to the BCIS dataset and define the time period.
Please be as specific and detailed as possible when compiling this list.

BCIS / NICOR Data User’s Agreement
To be signed when the application has been approved
Title, forename,
surname:
.
Work Address: .
.
.
Telephone: .
Email: .
Project title: .
I agree that my project will use the requested BCIS data and will be conducted
according to the terms specified in the BCIS / NICOR Data Sharing Policy.
I accept that my access to the BCIS data is limited only to what is relevant for
completion of the above named project.
I accept that if I knowingly disregard the conditions relating to the release of data
given in the BCIS / NICOR Data Sharing Policy this will be considered a serious
offence and will result in action being taken against me and my organisation.
I confirm that I have read this document and agree to abide by the terms and
conditions outlined within.
Signature of data user: .
Name in block capitals: .
Date: .
Signature of research members
(and everyone having access to
the data- see data sharing
agreement)
Names in block capitals
Date
.
.
.
.
.
.
.
.
.

Signature of BCIS Collaborator:
Name in block capitals: .
Date: .
Signature of BCIS Data Monitoring and Analysis
Group Chairman:
.
Name in block capitals: .
Date: .

Checklist for applicants
Download the BCIS dataset from the BCIS web pages to determine which data
items are available.
Download the BCIS Data Sharing Policy to understand what is required for your
submission.
Make informal contact with BCIS Data Monitoring and Analysis Group chair to
discuss feasibility of your project.
Download the BCIS / NICOR Data Application Form from the BCIS web pages.
Complete all sections of the BCIS / NICOR Data Application Form and return to
the BCIS Data Monitoring and Analysis Group chair with copies of your
organisation’s System Level Security Policy
project’s LREC/MREC approval or equivalent
After approval of your application in principle by the BCIS / NICOR
Complete, sign and return the BCIS / NICOR Data User’s Agreement to the BCIS
Data Monitoring and Analysis Group chair
Confirm safe receipt of data