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Protecting data

It is our responsibility that the data we receive from study participants and their rheumatology teams at the hospital are treated with the utmost confidence.

Data protection

We do share some minimal identifiable information (including NHS number and date of birth) with NHS national databases/registers such as NHS Digital (see table below for full list) to allow us to match identifiable information already held to provide additional healthcare data about study participants.

For example, if one of the participants registered on our study develops a cancer, then we will be informed of that cancer via a notification from the cancer register at NHS Digital.

NHS National Databases currently providing additional healthcare data to the study:

CountryServiceOrganisation
England Malignancy / Mortality service NHS Digital /Office for National Statistics
Wales Malignancy / Mortality service NHS Digital /Office for National Statistics
Scotland Malignancy / Mortality service NHSCR - NHS Central Register
Northern Ireland Mortality Service BSO - Business Services Organisation
Northern Ireland Malignancy service NICR - Northern Ireland Cancer Registry

We take data confidentiality seriously at the study and use four guiding principles when handling and processing the data that we receive.

People

Everybody associated with the study has completed training around data and information protection before working on the study and working with study data. In addition, all members of the team have completed Good clinical practice training developed by National Institute for Health Research (NIHR). These training courses are repeated every 2-3 years to maintain high standards in data protection and handling.  All staff also sign annual confidentiality agreements.

Security

Our data and information security is reviewed for use by NHS Digital (formerly Health and Social Care Information Centre; HSCIC) who ensures our security standards are acceptable for handling digital information. The University of Manchester has its own Cyber Security and Data Protection Policies which detail how digital information is handled, including confidentiality, integrity and availability and the use of encryption tools for the protection of sensitive information and communications.

See: Cyber security

The physical data questionnaires that participants provide to the study are kept locked and safe at the BSRBR-RA offices. The offices have a 24-hour security service and are protected by an alarm system. There is no public access to these offices and a 'clear desk and clear screen' policy is in operation.

Governance

The team at BSRBR-RA maintain high standards in data governance to ensure compliance with the Data Protection Act. We work closely with the Research Governance Office at the University. The study is open to internal audits by The University of Manchester Research Governance Office and external audits can be carried out at any time by study stakeholders including NHS Digital, the Medicines and Healthcare products Regulatory Agency (MHRA) or the National Institute for Health Research (NIHR).

Output

We frequently publish aggregated data as results from the study. These are shared and presented globally in publications and at conferences. The researchers who work on with the data will never have access to participants’ personal data or information because they use anonymised datasets.

Please see our patient information sheet for the most up to date information around BSRBR-RA data handling and usage.

How do study participants withdraw from the study?

The BSRBR-RA will be most valuable if few people withdraw from it, so potential participants are asked to discuss any concerns they might have with their rheumatology team or the BSRBR-RA team.

You can withdraw at any time from the study after giving your signed consent, by contacting the BSRBR-RA staff (phone, letter, email). We can then discuss the desired level of withdrawal from the following three options:

Option 1: No further participant contact

We will not send you any further questionnaires or surveys to you about your health, but we will continue to receive information from your rheumatology team at the hospital and via the linkage with the national databases.

Option 2: No further participant or hospital contact

We will not send you, or the rheumatology team at the hospital, any further forms or surveys asking about your health. Your record will still be linked with the national databases.

Option 3: Complete withdrawal

We will not send out any surveys or forms to yourself or rheumatology team at the hospital. We will also contact the national databases to un-link your record so no further information is received on your health status from the time you withdraw.

Concerns about the study?

If you have any concerns about any aspect of this study, you should speak to the researchers who will do their best to answer your questions. If they are unable to resolve your concern or you wish to make a complaint regarding the study, please see below.

Minor complaints

If you have a minor complaint, you need to contact the researchers in the first instance. Please get in touch with Dr Kath Watson:

Email: kath.watson@manchester.ac.uk
Tel: +44 (0)161 306 1898

Formal complaints

If you wish to make a formal complaint or if you are not satisfied with the response you have gained from the researchers in the first instance, please contact:

Tthe Research Governance and Integrity Manager
Research Office
Christie Building
The University of Manchester
Oxford Road
M13 9PL

Email: research.complaints@manchester.ac.uk
Tel: +44(0)161 275 2674 or +44 (0)161 275 2046