Confidentiality, GP/Consultant Involvement and Insurance

Will my taking part in the study be kept confidential?

Yes, all information which is collected about you during the research will be kept strictly confidential and will conform to the Data Protection Act of 1998 with respect to data collection, storage and destruction. This covers any information from your NHS records that we collect to complete a research checklist and to note any relevant medical or other factors relevant to the research. We will not make photocopies of any part of your notes. Your name and address is not recorded with the research information, instead we use a code number to identify your research data. Research data will be stored on computers in an encrypted (i.e. scrambled) form that can only be read with a ‘key’ held by one researcher. Blood samples taken for the cytokine and genetic analysis will only be labelled and identified via a unique ID and barcode with no personal details. Your GP will be notified of your participation in the study. If you are a patient we will also inform your care coordinator and psychiatrist.

In order to book in your scans for this study, some of your data needs to be sent to the scanning centre(s). The data to be sent will include information such as your name, date of birth and so on, but it may also include information about your health or medical history. The information will only include the essential details needed to book your scans and carry them out safely, it will not be used for any other purpose. The data will be transferred and held securely at the scanning centre. The data will be kept as part of the scanning records until it is no longer required at which point it will be destroyed in line with University/Trust procedures.

Authorised individuals from the participating Universities, the scanning centre, NHS Trust or regulatory authorities may need to access the data collected as part of this study to make sure that the research is being carried out properly. With your permission, the information looked at will include your personal data. All the authorised individuals have a duty of confidentiality to you as a participant in this research.

In the unlikely event that you have a loss of capacity to consent, the research team would retain any data collected and continue to use it confidentially in connection with the purposes for which consent is being sought.

Research data that is collected during the study will be stored anonymously for 15 years. This is in accordance with regulatory procedures. Any personal identifiable data will be removed from your research data, so your confidentiality will be continued after the completion of the study.

Involvement of GP/Consultant and Insurance

We would ask for your consent to write to your GP/Consultant to let them know of your participation in the study. We may also need to access relevant information from you medical files for research purposes and we are asking your consent to access this information. If there are any abnormal test results (excluding genetic findings) that could impact on your health, we would inform your GP/Consultant. Similarly, if we have any significant concerns about your mental health, we would inform your GP, and mental health team if you have one.  If there are any genetic findings relevant to your health, we would only inform your GP/Consultant if you have consented to find out yourself.

If you have consented to find out about any genetic risk factors and this does occur, any genetic test results from the study do not have to be disclosed to insurance companies. This applies to any current policies you hold, as well as for future applications for life insurance or private medical cover. This is covered by the UK Government’s ‘Concordant and Moratorium on Genetics and Insurance’.

With regards to taking part in the study generally, if you have private medical insurance we would advise you to check in the terms and conditions of your policy that participating in the study will not affect your cover. If you are seeking life insurance / private medical cover in the future, you would need to inform them of any abnormal test results from the study such as a brain lesion.