5. Who else will see my information?

Key message: there are some specific situations when we need to share information with other people or other organisations. We will always do this carefully and only when it’s really necessary. We will avoid sharing identifiable information about you whenever possible.

The patient information sheet you will get before you take part in any of our studies will go into detail about who will be able to see any confidential information about you for a specific study, including who might have access to your medical notes if you agree to take part.

Please see your information sheet for more on who may see your medical notes and other confidential information, if you take part in one of our studies.

There are some specific reasons why we sometimes need to share information with other people or other organisations. When we do, we will always share only the minimum information required for a specific, valid purpose. Whenever possible, we will share information in a way that means people who get it cannot see who you are. When we can’t do this, it’s because we need to share your details for a valid reason (see details in the sections below).

We will also make sure there is always an agreement or contract in place before we share any information. This will make clear that people who get the information can only use it for a specific purpose, must keep it secure, and cannot share it with anyone else.

We will never sell your information, or pass it on to people who will sell it. We will never share information for a reason that is not in the public interest, necessary for the study, or necessary to protect your safety or the safety of others. Information we share will not be used to make decisions about future services available to you, such as insurance.

In general, we do not share your information with anyone outside the United Kingdom in such a way that they could identify you. It is important you know this, because data protection laws may not be as strong in other areas of the world. If it might be necessary to do this for a particular study, this will be made clear to you in the patient information sheet before you agree to take part.

We will share your information for the following reasons, which you can find out more about below:

  • To run and analyse the study,
  • To get additional information from your medical records,
  • To keep you and other people safe,
  • To report to authorised people about the progress of the study,
  • To allow other researchers to carry out future research in the public interest,
  • Due to storage space limitations, we will store information securely away from the University of Leeds after the end of the study.

Click on the sections below to find out more.

5.1. Running and analysing the study

On some studies, we work with collaborators outside the University of Leeds who can help us because of specific expertise they have. The following is a list of examples of this, but other situations may apply – see your study patient information sheet for more information.

  • In some studies, a group of medical experts (for example, clinicians or radiologists) will review audio recordings, videos, photographs or medical images (for example, CT scans, MRI scans or X-rays) to check that your study treatment has been given correctly or that study measurements have been done correctly. These people will usually be based in the UK and will have agreed to keep all study information secure. We will send the information to them securely. When we share your information with them, it will only have your unique study identification number on, so they will not be able to see who you are. We will require them to destroy their copies of your information when the study is finished.
  • We may sometimes need to share information about you with doctors who work on a study, for further medical advice. This might include copies of medical reports and test results that your hospital has sent us, but they will always remove all information that could identify you before sending these to us (leaving only your unique study identification number). The doctors are usually based at NHS organisations in the UK. They are bound by their professional roles to treat your information securely at all times.
  • It is important for the reliability of some studies involving radiotherapy that we make sure people at different hospitals get the same sort of radiotherapy treatment. We use a team of radiotherapy experts at hospitals in the UK to help us check this. Your study doctor or nurse may securely send some details of your radiotherapy to the team at one of the hospitals involved. They will carry out their quality assurance checks, then send a summary report back to your study doctor. Sometimes a copy of the results will also be sent to us at the University of Leeds. The specialist team will only receive information with your unique study identification number on it, so they will not be able to see who you are. This network of specialists around the UK is called Radiotherapy Trials Quality Assurance (RTTQA) and you can find out more about them on their website: http://rttrialsqa.org.uk/rttqa/.
  • In some studies, researchers away from the University of Leeds will carry out study data analysis because they have particular expertise. We will only share the minimum information with them for them to do this, and this may include your unique study identification number but nothing else that could identify you. They will therefore not be able to see who you are from the information we share with them. We will send the information to them securely, and put in place a contract with them to make sure they use and store your information correctly. They will be required to securely destroy your information when the research is finished.

5.2. Accessing health information from your electronic health records

As well as the information that your hospital will send to us on the paper or electronic study forms, we will also obtain information about you held in NHS databases managed by NHS Digital (https://digital.nhs.uk/) or other providers. To do this, we will securely send some of your information (such as your name, your date of birth or your NHS or CHI number) to the information provider, and they will return the information about you that we need for the study. The patient information sheet you get when you are considering taking part in a trial will make clear how this works, if it’s happening in your study.

We do this because it is a more efficient way to collect certain information about your health. By using information collected from routine health visits, we can reduce the amount of time you and your hospital need to give to a study. When we do this, we will only use the information mentioned above to identify you. We will follow strict rules when working with other organisations to maintain confidentiality and protect your information.

NHS Digital and other providers will only provide information to us when they are satisfied that you have agreed to us doing this and that we need your information for research in the public interest. They also need to be satisfied that we will handle all your information securely. When they share your information with us, they can visit us to carry out an audit at any time to check that we are using your information correctly. You can find out more about the work of NHS Digital on their website:https://digital.nhs.uk/.

5.3. Keeping you and other people safe

It is very important to us that you remain safe when participating in our studies. If we learn anything new about the safety of treatments involved in our studies, we must share it quickly with relevant organisations so that people outside the study taking the same treatments are also kept safe.

When we run our studies, we have to follow laws and other rules that help protect your safety and the safety of others receiving the same treatments. These laws and rules require us to urgently collect details of certain types of serious health event from your hospital (for example, if you have a problem that means you have to stay in hospital overnight). We share these reports with doctors working on our behalf, usually in the UK. They can advise us on whether any urgent action needs to be taken to protect you or other people taking part in the research. The reports we share will contain only your unique study identification number, initials and date of birth, so there isn’t any way that these doctors could identify you from the limited information we share with them about this.

If an event seems like a new type of side effect that no one else has had before, we must report this urgently to the Research Ethics Committee that has approved the study. For studies involving medicines, we must also report urgently to the regulatory authority (the Medicines and Healthcare products Regulatory Agency, or MHRA). We also sometimes need to share the information with doctors at other healthcare centres taking part in a study.

This information sharing is very important because if we find a previously unknown type of side effect of the treatment, we need to tell doctors and patients about it quickly (but without identifying you). We will also report to the pharmaceutical companies that make the treatments involved, so that they have a complete record of any problems occurring. The information we share with these organisations has only your unique study identification number on (not any other identifier), so there isn’t any way they could identify you.

Collection of this type of information is required by law in studies that involve medicines, so we will need to continue doing it even if you decide to stop taking part in the study. See section 8 for more about this.

To help us with protecting patient safety, you should always tell your doctor about any health events you have experienced during or after you take part in the study.

Other ways we may use information about you to keep you safe:

  • In some of our studies, your study doctor and nurse will not know what treatment you are receiving. This is so that their decisions and behaviour are not influenced by their knowledge of your treatment. This sort of study is called a ‘blinded’ study, and can have more reliable results than non-blinded studies. The patient information sheet about a study will make clear if your study is a blinded study. In the unlikely event of a medical emergency happening while you are on a blinded study, your study doctor and nurse might need to urgently find out what treatment you have had. They can do this by providing your unique study identification number either to a specific team at the University of Leeds, or through a service provided by another organisation. They will then instantly receive the details of your treatment. No other information about you will be used in this process.

5.4. Reporting on the progress of the study

We are required to provide updates on our studies to various organisations and groups. Each study cannot start until it is reviewed and approved by a Research Ethics Committee and, for studies involving medicines, the regulatory authority (the Medicines and Healthcare products Regulatory Agency, or MHRA). After they have approved each study, we need to send these groups regular updates so that they can check how the study is being run. We also need to provide updates to the funder of each study so that they can check we are using their funding as we said we would. We also provide some information to independent groups of experts who regularly check that the study is safe to continue. These groups can include ‘Trial Steering Committees’ and ‘Data Monitoring Committees’.

All these individuals and organisations are usually based in the UK. We only ever share very limited information with them. There is no way you could be identified from any reports. The reports will either just show groups of people (such as a total number of people who have joined the study), or information that does not allow individuals to be identified (for example showing just your unique study identification number).

5.5. Making information available for other research

Information we collect for each study is made available to other researchers in other organisations at the end of the study for additional research, including information you have already provided if you stop taking part in the study. This will not include any information that could identify you. Your information will not be shared if you have explicitly said you did not want this to happen.

Collecting information for research studies takes a lot of time and effort. Sharing the study information for future research projects is an important way we can make the most of this time and effort, including the time the research participants themselves have given.

These other organisations may be in other countries, including outside the United Kingdom where data protection laws may be different. However, information will only be shared in such a way that no individual people can be identified from the information (either on its own or in combination with other information).

We will also only share this information for worthwhile research projects with appropriate approvals (including approval from a research ethics committee), and only when we are sure the other researchers will manage your information correctly and securely, wherever they are based. Before we share information with anyone, we will put in place contracts to make sure the other researchers store the information securely, that only authorised people will access the information and that the researchers will destroy their copy of the information when their research is over.

We may also use study information for additional research projects within the University of Leeds. We will only agree to do these projects if they are worthwhile research projects that have all the appropriate ethical approvals. If people outside the original study team are involved, we will only share the minimum information with them that they need for the new project, and we will remove any clearly identifiable information (such as your name) before sharing.

We will never sell your information, and there is no way that it could be used to make decisions about insurance or anything else that might affect you in future.

5.6. Long-term storage

To comply with laws and policies around research, we need to keep your information for a time after each study has finished. The amount of time applying to a specific study will be made clear in the patient information sheet before you agree to take part.

Due to storage space limitations, it may be difficult for us to keep all the paper documents within the University of Leeds for the required length of time. We may therefore ask a reputable archiving company to securely store the paper documents away from the University (but still within the UK) after the end of the study. We will only do this when we are sure the company will hold your information securely, and we will always have a contract in place with the company to make sure they are accountable for how they store your information.