(6) More information about taking part

Do I have to take part in the AND-PD study?

No, it is up to you to decide whether or not to take part. If you decide to take part, you will be given a information sheet to keep and you will be asked to sign a consent form. If you decide not to take part in this study, will not affect the standard of care you receive.

Will I get back any travel costs?

You may be able to claim money to cover additional travel expenses incurred for study visits (up to a maximum of £10 per visit). Please speak to your study doctor/nurse.

Can I stop taking part after I’ve joined the study?

You can stop taking part in the study at any time and without giving a reason. A decision to stop taking part at any time will not affect the standard of care you receive. You can withdraw from the study at any point. If you do withdraw, the study team will keep data already collected but will not collect any additional data.

What will happen to information about me collected during the study?

If you consent to take part, the records obtained while you are in this study, as well as related health records, will remain strictly confidential at all times. The information will be held securely on paper and electronically under the provisions of the 2018 General Data Protection Regulation (GDPR). To safeguard your rights, we will only collect the details that identify you, for example your name and contact details, that are needed for the study. These details will not be passed to anyone else outside the research team or the Sponsor (UCL), who is not involved in the study.

When you enrol in the study you will be allocated a unique number, which will be used as a code to identify you on all study forms. This means your data is pseudoanonymised.

Your records will be available to people authorised to work on the study but may also need to be made available to people authorized by the Sponsor, which is the organization responsible for ensuring that the study is carried out properly. All will have a duty of confidentiality to you as a research participant.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

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

You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients/, UCL website or https://www.ucl.ac.uk/legal-services/privacy · our leaflet available from Sponsor Data Protection Officer data-protection@ucl.ac.uk · by asking one of the research team · by sending an email to and-pd@ucl.ac.uk or Sponsor Data Protection Officer data-protection@ucl.ac.uk · by ringing us on 020 8016 8181

Data will be stored on manual paper files, on a secure database (REDCAP), NHS computers, university computers and laptop computers.

If the study research team are unable to contact you at any time during the study, with your permission, they will access the relevant sections of your medical records on NHS Digital (Spine) to obtain your contact details.

You can find out more about how we use your information at www.ucl.ac.uk/cctu/use-of-data.

What will happen to the results of the AND-PD study?

We will publish the results in a medical journal, so that other doctors and researchers can see them. Your identity and any personal details will be kept confidential. No named information about you will be published in any report of this study.

Who is organising and funding the study?

This study is organised by University College London (UCL).

University College London has overall responsibility for the conduct of the study. They are responsible for ensuring the study is carried out ethically and in the best interests of the study participants. Funding for this research has come from an EU Commission grant Horizon202 grant 848002.

What if new information becomes available during the study?

Your doctor might also suggest that it is in your best interests to stop taking part in the study. Your doctor will explain the reasons and arrange for your care to continue outside the study.

What happens if the AND-PD study stops early?

Very occasionally a study is stopped early. If it happens, the reasons will be explained to you and your doctor will arrange for your care to continue outside of the study.

What if something goes wrong for me?

Every care will be taken during this AND-PD study to ensure that your well-being is not compromised. If, however you have a concern about any aspect of this study, please feel free to contact a member of the research team (see contact details below). We will do our best to answer your questions or concerns. If you are not satisfied with this, you can make a formal complaint using the normal NHS (National Health Service) procedures. Details can be obtained from the Department of Health website: http://www.dh.gov.uk. You can do this within 12 months of the events concerned, or within 12 months of becoming aware of the problem.

Your complaint will be recorded as part of our formal complaints policy. You can contact the confidential patient advice and liaison service (PALS). PALS was set up to support patients, their families and visitors who need advice or have problems and concerns. The contact details for PALS at the Royal Free Hospital are: Tel: 020 7472 6446 or 020 7472 6447 (open from 10am to 4pm, Monday to Friday). 24-hour answer phone: 020 7472 6445 Fax: 020 7472 6463 SMS: 447860023323 (Deaf and hearing-impaired patients only) Email: rf.pals@nhs.net

In the unlikely event that you are injured by taking part, compensation may be available. If you suspect that the injury is the result of the Sponsor’s (University College London) or the hospital’s negligence, then you may be able to claim compensation. After discussing with your study doctor, please make the claim in writing to Prof Anette Schrag who is the Chief Investigator for the study and is based at The Royal Free Hospital. The Chief Investigator will then pass the claim to the Sponsor’s Insurers, via the Sponsor’s office. You may have to bear the costs of the legal action initially, and you should consult a lawyer about this. Participants may be able to claim compensation for injury caused by participation in this study without the need to prove negligence on the part of University College London or another party. You should discuss this possibility with your study doctor in the same way as above.

Who has reviewed this study?

All research in the NHS is reviewed by an independent group of people, called a Research Ethics Committee (REC) which is there to protect your safety, rights, wellbeing, and dignity. This study has been reviewed and given a favourable ethical opinion by the Research Ethics Committee (REC) and the Health Research Authority (HRA) in accordance with UK regulations.