PRIVACY

Do I have to take part?

It is up to you to decide whether or not to take part. You may find it helpful to talk to others (e.g. staff or a family member) about this. You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.

What would taking part involve?

You will be asked to give your informed consent to take part in the study. This will include seeking your agreement to take part in research assessments as well as to taking part in the study.

Then you would complete a survey interview, where you will be asked questions about yourself, your sleep, your motivation levels and any ideas you may have about how we can improve sleep for people at Roseberry Park. We estimate this to take no longer than 45 minutes.

After completing the survey interview, you may be asked to take part in a focus group which will commence once we have completed the survey interviews with other participants over a 3-month period. In the focus group, you will discuss the results of the survey interviews with other participants and discuss ideas around creating a new sleep intervention.

What are the possible benefits of taking part?

The main benefit for you is the knowledge that you are taking part in research that is likely to help improve the care that is provided to people at Roseberry Park Hospital.

Additionally, to thank you for taking part in this research and to compensate you for the time you will spend taking part in the study, you will be offered a £10 shopping voucher.

What are the possible disadvantages and risks of taking part?

You may find it distressing to answer the researchers’ questions regarding sleep during your survey interview. It is absolutely fine to take a break or stop the session if this occurs.

Will my participation in this study be kept confidential?

We will need to use information from you, and your NHS medical records for this research project.

This information will include your initials, NHS number, name and demographic information such as your sex and age. People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

You have the right to ask us to remove, change or delete data we hold about you for the purposes of the study. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.

Tees Esk and Wear Valleys NHS Foundation Trust is the sponsor of this research and is responsible for looking after your information. We will keep all information about you safe and secure by:

• Original paper versions of consent forms will be stored in a locked site file cupboard only accessible by the research team at Tees, Esk and Wear Valleys NHS Foundation Trust.

• Encrypted NHS laptops will be used to collect the survey interview data on a site called Qualtrics, where backups of the data are encrypted.

Where can you find out more about how your information is used?

You can find out more about how we use your information by:

1. Reading our Trust’s privacy notice at https://www.tewv.nhs.uk/about/publications/privacy-notice/

2. By contacting our sponsor’s data protection officer at 

• Telephone: 0191 333 6574 

• Email: tewv.dpo@nhs.net 

What will happen to the results of the study?

With your consent, we will write to you when the study has finished to update you on its progress.

The final results of the study will be shared as widely as possible through NHS and research communities of practice, conferences, and submitted for publication with scientific journals. No publication that uses data from this study will include your personal details, or information that can identify you in any way. Direct quotations by participants may be used in the dissemination of our study. In all cases, we will maintain anonymity of participants and make sure participants are non-recognisable.

What will happen if I lose capacity to consent?

If you become very unwell during the study, you may be withdrawn from the study (i.e. you would stop taking part), but we would keep the information you had provided up to that point.

Who has reviewed this research?

This study has been reviewed and funded by the ‘National Institute for Health Research’ ‘Research for Patient Benefit’ (RfPB) programme.

A Patient and Public Involvement group has helped to shape and develop this study. This group includes people who have experienced being in a psychiatric inpatient service.

Who can I contact?

If you have any further questions or things that you would like to have clarified before you decide if you want to take part or not, please free to contact our research team:

TEWV.researchanddevelopment@nhs.net

Tel: 01642 283501

The contact details of lead researcher (Chief Investigator) are:

Dr Anne Aboaja

Tel: 01642 837527

TEWV’s complaints team:

Tel: 0800 0520219

Text: 07733001221

SIESTA IRAS Number: 332439