Being involved in the studies
Both the BCRD and BSPAR ETN studies have been reviewed and approved by the Research Ethics Committee, and are overseen by a highly experienced Consultant Rheumatologist who is also a Professor of Epidemiology (the study of disease) at The University of Manchester, Professor Kimme Hyrich.
Registering for the correct study
- Participants starting etanercept (Enbrel or any etanercept biosimilar) are registered with BSPAR ETN.
- Participants starting any other biologic/biosimilar (ie not Enbrel or an etanercept biosimilar) are registered with BCRD.
When is information is collected during the study?
- Information supplied to studies at “baseline” (ie the time you start treatment).
- Additional follow-up information collected six months after you start treatment.
- Further follow-up information collected at 12 months, then annually for at least five years . This data collection may be continued on an annual basis dependent on additional funding being received to extend the study. Some participants have been involved for over ten years now.
Participants are flagged with NHS digital
All participants are “flagged” with NHS digital, who will then inform us if any of the participants on our studies develop a serious illness such as cancer, or if they pass away.
What does being “flagged” mean?
An organisation called NHS Digital has information about the health of everyone in the country, and they store details about any hospital stays or serious illnesses that people experience. When you consent to be involved in the BCRD or BSPAR ETN study you give consent for your name, date of birth and NHS number (or CHI number if you are in Scotland) to be shared with other national databases (including NHS Digital). This is for the purpose of matching identifiable information already held by these national databases so that they are able to “flag” you. This flag means that if you experience a really serious illness, such as cancer, then the research studies will be informed of these events directly by the national databases. This is a resource that is really important for research into health and diseases such as JIA, as the information that we get from NHS Digital and other national databases is added to the information that we collect from your healthcare team. This makes our data more complete, stronger and more reliable. In addition to collecting information from your hospital notes and by linking to NHS Digital, we also collect a blood or saliva sample for genetic studies.
At the end of the study
Questions or concerns about the study?
If you have any concerns about any aspect of this study, you should speak to the study coordinators 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.
If you have a minor complaint, please get in touch with the Chief Investigator of the studies:
Professor Kimme Hyrich
tel: +44 (0)161 275 1679
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:
The Research Governance and Integrity Manager
The University of Manchester
tel: +44 (0)161 275 2674 or +44 (0)161 275 2046