Information for study participants

The University of Aberdeen, as data controller for BSRBR-AS study, is responsible for processing your data fairly and lawfully according to the General Data Protection Regulation (2018). Processing data means collecting, using and sharing the data you provided in your study questionnaires and diary cards, plus the data your rheumatology team collected for the study from your usual clinical care. Data processing will only ever be for the purposes of this study. When you signed the consent form to participate in the BSRBR-AS study you gave us permission to process these data. It is our responsibility that the data we received from study participants, and their rheumatology teams, have been treated with the utmost confidence.

• All study materials identified you using a unique ID number. Your name and contact details have been stored separately from all other study materials.  All data storage (both paper and electronic) has been kept secure at all times.
• We blanked out your name on every diary card we ever received from you before we filed it.
• Only study personnel have had routine access to your data.  There is no public access to the BSRBR-AS offices. A “clear desk and clear screen” policy is in operation.
• Every person working on the study was trained and certified in Good Clinical Practice training which is repeated every 2-3 years to maintain high standards in data protection and handling.

The team at BSRBR-AS maintained high standards in data governance to ensure compliance with the General Data Protection Regulation. We worked closely with the Research Governance Office at the University. Further information can be found in the BSRBR-AS Participant Transparency Information Sheet. The study is open to internal audits by the University of Aberdeen Research Governance Office and external audits can be carried out at any time by study stakeholders including NHS Digital, or NHS Research Scotland. Our secure study database is held at the Robertson Centre for Biostatistics (RCB) at the University of Glasgow. The University of Glasgow has their own Information Security policy which is accessible through their website (https://www.gla.ac.uk/myglasgow/it/informationsecurity/). The RCB have a registered safe haven and are ISO 27001 accredited. Their ISO accreditation is audited and reviewed annually.

Researchers outside the BSRBR-AS can apply to the British Society for Rheumatology to get access to an anonymised study data set to answer important research questions. Each application undergoes a review process by an expert panel and if the application is successful contracts will be put in place before any data will be passed on. If your information is provided as part of a larger dataset to researchers outside of the BSRBR-AS team, we will not include any information that could identify participants. We will also replace the unique study ID with another random ID number.

When you consented to take part in the study you were asked if you agreed that we could link the data we collect from you, and your rheumatology team, to data about your healthcare that are held in a national NHS database. If you agreed to this we share some identifiable information (including your name, NHS or CHI number, address and date of birth) with NHS national databases/registers such as NHS Digital (see table below for full list). This allows us to get additional information about your health, for example about hospital stays, appointments outside rheumatology, or if you develop a serious condition such as cancer. It lets us check information we already have and to fill in the gaps where information is not complete.

With this additional information we will be able to build a more complete picture of Ankylosing Spondylitis (AS) and the safety of biologic treatment. We will also be able to work out the healthcare costs associated with AS from the number of out-patient and inpatient hospital appointments you have. We will not get any data from your GP through data linkage.  

We have applied for the approval to obtain additional health care data from the following NHS National Databases:

Your right to withdraw your data is limited. If you notified us that you wish to withdraw from the study before 30th June 2018, we will have stopped collecting data about you.  However, we will use the data collected prior to your withdrawal.

We publish combined data as results from the study. These are shared and presented globally in publications and at conferences. The researchers who work with the data will never have access to participants’ personal data or information because they used anonymised datasets. To read what we have published so far please come back to this page it will be updated as the results become available.

During the course of the study we sent out newsletters to those taking part.  To view a newsletter click on the following links:

• Patient newsletter December 2013
• Patient newsletter December 2014
• Patient newsletter December 2015
• Patient newsletter December 2016

We also published a research update in AS News, the magazine of the National Ankylosing Spondylitis Society, in Spring 2018, to get a copy please contact NASS directly.

The BSRBR-AS study team at the University of Aberdeen are unable to answer medical patient queries. If you have any medical questions please contact your GP or rheumatology team. There are two charities that offer support to those living with AS, see below.

• NASS (National Ankylosing Spondylitis Society) is a national charity providing support, information and advice to people with AS  http://nass.co.uk/
• Arthritis Research UK is a national charity providing support, information and advice to people affected by any kind of arthritis. They also fund research to make life better for all people with arthritis in the UK.   http://www.arthritisresearchuk.org/