What happens if relevant new information becomes available about the screening tests in the trial?

Sometimes new information becomes available about the tests that are being studied. If you are in TRANSFORM and this happens, the study team will tell you about it and discuss whether you want to, or should, continue in the study. If you decide not to carry on, your study team will plan for your care to continue with your GP. If you decide to continue in the study, you will be asked to sign a consent form that includes the new information.

What if the study team find something new about my health? 

We will provide the results of your Prostate Health Check to both you and your GP. Rarely, we may information that could impact your diagnosis or treatment or indicate an inherited condition that could affect you or your family. If this happens, we will contact you to explain the findings and give you advice about what to do. We will also inform your GP.

What are the alternatives?

If you choose not to take part, your healthcare will continue as normal with your GP. We will still collect information about your health status through your GP practice and NHS or national records, but you won’t be contacted directly.  You can opt-out of this at any time, as explained in the section.

How will you follow my health over time?

We are also keen to find out why you did not wish to take part. We may contact you to invite you to take part in a brief interview about your thoughts and opinions on the study. The interview will be scheduled at a time that is convenient for you. Your views and opinions will help the study team understand your experiences so that we can improve future studies. You do not have to agree to this.

What are the possible benefits and disadvantages of the study?

There may not be any personal benefits for you. We are doing the study to find out if a Prostate Health Check might be beneficial as a screening approach for prostate cancer. As the answers to this question may take many years and are affected by the pros and cons of screening that we described earlier, we cannot know whether you will personally benefit.

By taking part, you are playing an essential role in research and will be helping future generations. You will provide important information to help us find out if screening might work in the community. We will use this information to decide whether a bigger study is needed and how best to design that study. 

What happens when the study stops?

Once you have completed the study, your care will be as normal practice. The type of care will depend on your individual circumstances and clinical details. Your GP will continue to look after your healthcare.

What if there is a problem?

If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions. Contact details are at the end of the document. If you remain unhappy and wish to complain formally, you can do this via the hospital’s Patient Advisory Liaison Service (PALS).

Site/Hospital to insert local details

Tel: Site/Hospital to insert local details

http://www.nhs.uk/chq/pages/1082.aspx?CategoryID=68

Every care will be taken in the course of this study. However, in the unlikely event that you are injured by taking part, compensation may be available. Imperial College London holds insurance policies which apply to this study. If you experience harm or injury as a result of taking part in this study, you will be eligible to claim compensation without having to prove that Imperial College is at fault. This does not affect your legal rights to seek compensation. If you are harmed due to someone's negligence, then you may have grounds for legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Chief Investigator (Professor Ahmed via email on transform@imperial.ac.uk). The normal National Health Service mechanisms are also available to you. If you are still not satisfied with the response, you may contact Imperial College, Research Governance and Integrity Team at rgit@imperial.ac.uk.

Will my taking part in this study be kept confidential?

Yes. All information that is collected about you during the study will be kept strictly confidential. Your data will be identified by a unique study number, rather than your name. This number will be used to link to your personal details only when necessary, such as for collecting your health information from national health records. If you consent to take part in this study, we will collect information on you and your test results, and we will enter it onto a secure study database held at Imperial College Trials Unit, London. This is for the purpose of analysing the results.  Employees of the Imperial Clinical Trials Unit (ICTU) and staff from Imperial College London Research Governance and Integrity Team may need to examine your medical records to ensure the study is being run properly, but your confidentiality will be protected at all times, and your name will not be disclosed outside the study. Your information may also be looked at by an independent quality control agency to check that the study is being carried out correctly. 

Your GP will be informed in writing of your participation in this study. They will also be advised of any medically relevant events during the study as well as any clinically relevant study results. We will ask your GP for medical information about you in the future as well as looking at your hospital records. It is standard practice to inform your GP about your participation in a study. If you do not wish this to happen, you cannot participate in this study.

If you consent to join the study but later lose the capacity to give informed consent, you will be withdrawn from the study. Any identifiable data, samples and scans already collected while you had capacity will be retained and used in the study. However, no further data or tissue will be collected, and no additional research procedures will be carried out. We will continue to collect routine follow-up information from national health records.

How will you use information about me?

Imperial College London is the sponsor for this study and will act as the data controller for the study. Being a Data Controller means that we are responsible for looking after your information and using it appropriately plus are responsible for explaining this to you. Imperial College London will keep your personal data for:

• 30 years after the study has finished in relation to data subject consent forms.

• 30 years after the study has completed in relation to primary research data.

The study data will then be fully anonymised and securely archived or destroyed. 

The study is expected to finish in 2048.

For more information / confirmation regarding the end date please contact the study team, see ‘Where can I find out more about how my information is used’ for contact information.

We will need to use information from you and your medical records for this research project.  This information will include your initials, NHS number, name, date of birth, demographics (such as ethnicity, partial post code) and contact details.  

People within the College and study team (see section on sharing your information with others) will use this information to do the research or to check your records to make sure that research is being done properly and the information held (such as contact details) is accurate. 

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. 

Imperial College London 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: 

• Data management plans have been created and reviewed in line with Imperial’s Information Governance Policy Framework. This covers collection, movement, processing and storage of data.

• Data to be stored in a dedicated secure environment which underpins security measures.

• Data will be stored in ISO 27001 certified and/or Cyber Essentials accredited environment

• Robust pseudo anonymisation has been implemented to prevent identification.

• Access controls have been implemented to ensure only key personnel can access the data

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.

As a university we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research.  This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Our legal basis for using your information under the General Data Protection Regulation (GDPR) and the Data Protection Act 2018, is as follows:

• Imperial College London – “performance of a task carried out in the public interest”; Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.

Where special category personal information is involved (most commonly health data, biometric data i.e. finger prints or facial recognition and genetic data, racial and ethnic data etc.), Imperial College London relies on “scientific or historical research purposes or statistical purposes”.

International transfers

We may share data about you outside the UK for research related purposes: 

• Where necessary to provide access to a data processor / service provider who will utilise your personal data as instructed by us. 

• Where necessary to share with a third-party organisation / collaborator (as listed) who are also involved in the study. 

• Where data has been collected from outside the UK and requires additional transfer(s) as part of the study activity. 

If this happens, we will only share the data that is needed. We will also make sure you can’t be identified from the data that is shared where possible. This may not be possible under certain circumstances – for instance, if you have a rare illness, it may still be possible to identify you. If your data is shared outside the UK, it will be with the following sorts of organisations: 

• Academic and commercial partners involved in the study.

• Due to the nature and scope of the study, new partners may join the study over time. 

• A list of study partners is maintained and regularly updated by the central study team. If you would like to access this list, please contact the team by email at transform@imperial.ac.uk or by calling [insert phone number].

We will make sure your data is protected. Anyone who accesses your data outside the UK must do what we tell them so that your data has a similar level of protection as it does under UK law. We will make sure your data is safe outside the UK by doing the following:

• (some of) the countries your data will be shared with have an adequacy decision in place. This means that we know their laws offer a similar level of protection to data protection laws in the UK 

• we use specific contracts which stipulates that personal data must maintain the same level of protection when outside the UK as it has within the UK. For further details visit the Information Commissioner’s Office (ICO) website - www.ico.org.uk

• we do not allow those who access your data outside the UK to use it for anything other than what our written contract with them says 

• we need other organisations to have appropriate security measures to protect your data which are consistent with the data security and confidentiality obligations we have. This includes having appropriate measures to protect your data against accidental loss and unauthorised access, use, changes or sharing 

• we have procedures in place to deal with any suspected personal data breach. For further details about UK breach reporting rules visit the Information Commissioner's Office (ICO) website - Personal data breaches: a guide | ICO

Sharing your information with others

We will only share your personal data with certain third parties for the purposes referred to in this participant information sheet and by relying on the legal basis for processing your data as set out above. 

• Other Imperial College London employees (including staff involved directly with the research study or as part of certain secondary activities which may include support functions, internal audits, ensuring accuracy of contact details etc.), Imperial College London agents, contractors and service providers (for example, suppliers of printing and mailing services, email communication services or web services, or suppliers who help us carry out any of the activities described above). Our third-party service providers are required to enter into data processing agreements with us. We only permit them to process your personal data for specified purposes and in accordance with our policies. 

The following are Research Collaborators / Partners in the study:

• Wolfson Institute, Queen Mary, University of London – Statistical analysis and Behavioural Sciences evaluations

• University College London – Sample processing for genetic evaluation and processing and storage of imaging data

• London School of Hygiene and Tropical Medicine – Health Economic analysis

• University of Manchester – Behavioural Sciences evaluations

• University of Lancashire Behavioural Sciences evaluations

• The Institute of Cancer Research London – Genetic sample evaluation

• The University of Cambridge – Genetic sample evaluation

• InHealth – Appointment booking and Prostagram™ delivery

• Deep Health – MRI (Prostagram™) storage and transfer

• A list of collaborators including all third-party organisation is maintained and regularly updated by the central study team. If you would like to access this list, please contact the team by email at transform@imperial.ac.uk or by calling [insert phone number].

Potential use of study data for future research

When you agree to take part in a research study, the information collected either as part of the study or in preparation for the study (such as contact details) may, if you consent, be provided to researchers running other research studies at Imperial College London and in other organisations which may be universities or organisations involved in research in this country or abroad. Your information will only be used to conduct research in accordance with legislation including GDPR and the UK Policy Framework for Health and Social Care Research.

This information will not identify you and will not be combined with other information in a way that could identify you, used against you or used to make decisions about you. 

Commercialisation

Samples and data from this study may also be provided to organisations not named in this participant information sheet, e.g. commercial organisations or non-commercial organisations for the purposes of undertaking the current study, future research studies or commercial purposes such as development by a company of a new test, product or treatment. We will ensure your name and any identifying details will NOT be given to these third parties, instead you will be identified by a unique study number with any sample / data analysis having the potential to generate ‘personal data’.   

Aggregated (combined) or anonymised data sets (all identifying information is removed) may also be created using your data (in a way which does not identify you individually) and be used for such research or commercial purposes where the purposes align to relevant legislation (including the GDPR) and wider aims of the study.  Your data will not be shared with a commercial organisation for marketing purposes. 

What are my choices about how my information is used? 

• 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. 

• you have the right to ask us to access, remove, change or delete data we hold about you for the purposes of the study. You can also object to our processing of your data. 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. 

• If you choose to stop taking part in the study, we would like to continue collecting information about your health from central NHS records, your hospital, and your GP. If you do not want this to happen, tell us and we will stop. 

• If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study. 

Where can I find out more about how my information is used?

You can find out more about how we use your information, including specific mechanisms used by us when transferring your personal data out of the UK. 

• at www.hra.nhs.uk/information-about-patients/

• by asking one of the research team

• by sending an email to transform@imperial.ac.uk

• by ringing us on [Insert telephone number]

What if I wish to make a complaint?

If you wish to raise a complaint about how we have handled your personal data, please contact the research team first by sending an email to transform@imperial.ac.uk, or by ringing us on [phone number].

Following our response, if you are not satisfied please contact Imperial College London’s Data Protection Officer via email at dpo@imperial.ac.uk, via telephone on 020 7594 3502 and/or via post at Imperial College London, Data Protection Officer, Faculty Building Level 4, London SW7 2AZ. 

If you remain unsatisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO)- via www.ico.org.uk. Please note the ICO does recommend that you seek to resolve matters with the data controller (us) first before involving them.

What will happen to the results of the study? 

Large research studies such as this take several years to complete. The results from this study will be used to improve treatment and care of patients in the future. The results will be published as appropriate in scientific or medical journals and may be presented at scientific and medical meetings. Results will also be available to patients and the public using: easy to read summaries, webinars, podcasts, social media summaries and infographics. Regular updates of research in progress, research results and other relevant information will be published on the Prostate Cancer UK website at prostatecanceruk.org.

You will not be identified in any publication or through any information on the website. 

At the end of the study, we can send you a summary of the results if you would like to see them. 

Who is organising and funding the study?

The study is funded by Prostate Cancer UK (PCUK) and the National Institute for Health Research (NIHR). The study is sponsored by Imperial College London. Our team is experienced and has carried out numerous studies in prostate cancer diagnosis and treatment. The Chief Investigator for the study is Professor Hashim Ahmed. 

Who has reviewed the study?

All studies in the NHS are reviewed by an independent group of people, called a UK National Research Ethics Committee, which is there to protect your safety, rights, wellbeing and dignity. The study has been reviewed and approved by the Wales REC 5 Research Ethics Committee and the Confidentiality Advisory Group. It has also been reviewed by patient representatives and independent international experts for the funders and the National Cancer Research Institute’s Prostate Research Group.

Will I get paid for taking part? 

There is no payment for taking part in this study. 

Will researchers receive any payments for conducting the study? 

Some radiologists in this study will be paid for the time they take to report additional scans for this study. All other researchers won’t receive any personal payments over and above normal salary, or any other benefits or incentives.