Participant Information Sheet - Healthy Volunteer: the latest version (V3, 06/05/2020)
Study title: Cancer Loyalty Card Study (CLOCS)
- We would like to invite you to a research project that aims to investigate whether or not women have distinctive self-management behaviours prior to seeing their doctor with symptoms that are associated with ovarian cancer.
- Before you decide to take part, it is important that you understand why the research is being conducted and what it will involve. Please take time to carefully read the following information and feel free to contact us if anything is not clear.
What is the purpose of the study?
About 7,400 women are newly diagnosed with ovarian cancer in the UK every year, and 1 in 5 women diagnosed with ovarian cancer do not receive treatment, mostly because they’re too unwell to start treatment by the time they are diagnosed. This could partly be because ovarian cancer symptoms are vague and not well known. Women usually report in research that they did not think their symptoms were associated with ovarian cancer even when the symptoms became too painful and debilitating. We believe information about how often and what products women purchase (e.g. pain killers, digestive products and natural remedies) to self-manage these early symptoms could help identify ovarian cancer a few crucial weeks earlier.
The Cancer Loyalty Card Study (CLOCS) is focused on improving early detection of ovarian cancer.
We are investigating whether or not your everyday loyalty card use in high street retailers can help identify early signs of ovarian cancer. CLOCS aims to compare purchasing patterns of women with (cases) and without (controls) ovarian cancer diagnoses in order to potentially develop a way to detect cancer earlier.
Who can take part in this study?
Women 18 years and older who have not been diagnosed with ovarian cancer and are current holders of Boots Advantage Card and/or Tesco Clubcard are eligible to take part in this study as control participants. You don’t need to be a frequent userand you only need to have at least one of these cards. Ovarian cancer patients are also eligible to take part in this study.
What do I have to do?
There are two steps to taking part in CLOCS using our website (www.clocsproject.org.uk).
Step 1: Online consent and a short questionnaire
If you wish to take part after reading the information about CLOCS, you will be able to complete the consent form and the short questionnaire. Please press Submit at the end of the survey for your responses and your consent to be to be recorded.
Step 2: Participant Identity Verification for Data Portability
To be able to request your data on your behalf from the retailers, we are required to confirm your identification and match the name on the consent forms using a proof of address and a copy of ID. We cannot request data without this process. This is in line with your right to data portability rights under GDPR, and to protect your data in case someone else took part in this study on behalf of you.
The identity verification will take place after you press the submit button on the survey. We have come up with a separate encrypted link that will allow you to upload the required documentation either in an image (e.g. jpg., png) or in a pdf format. In this link, you will need to consent to the ID verification process and upload a photo ID (e.g. passport or drivers licence) and a utility bill (e.g. electricity or council tax bill). If you don’t provide this information, we will not be able to request your data on your behalf.
If you cannot complete this immediately after taking part, you can submit the documents in your own time when you can gather the necessary images or documents. We will send you a reminder with a link to the ID verification page within a week if you have not completed this previously. Without the ID verification, we cannot request your loyalty card data.
Your ID verification documents will be stored in Imperial College’s ISO27001 certified secure environment – the “Secure Enclave” (see “Where will you store my data” below for more information). A member of the CLOCS research team will review your name and address on the documents you provided, confirm they match those on your consent form, and then they will be permanently deleted.
If you would prefer to complete the consent form and questionnaire on paper instead of the website, please contact the research team at firstname.lastname@example.org to receive a participant pack in the post.
The first set of data will be collected from two high street retailers through your use of loyalty cards. This includes data about the items you purchased (e.g. paracetamol), when (i.e. date of purchase) and where you purchased them (i.e. store postcode). This will not include information on NHS prescriptions or any personally identifiable information, e.g. full name, postcode, ethnicity. Your loyalty card past purchase information will only be collected one time from the participating high street retailers. The CLOCS team will request your past purchase data from at most 6 years ago (depending on the high street retailer’s records and when you obtained a loyalty card) to the date you complete the consent form.
Participant Questionnaire Data
The second set of data will be collected through the participant questionnaire. Our questionnaire is designed specifically to investigate your ovarian cancer risk based on previous evidence. For this reason, we have included questions about you, your reproductive history, your cancer history (if any), other medical history, and about your loyalty card use.
YES. Your identity will be kept confidential at all times. Only the research team will have access to the paper based consent forms which will be kept in a secure locker and the online secure server. You will be given a unique study ID which means all datasets will be pseudonymised, i.e. none of your identifiable information will be on our final dataset. You can request the list of information being used in this project from the research team via the contact information provided at the end of this information sheet.
Once we receive your consent, we will share your consent for each specific retailer to request your data on your behalf. They will check your information to verify that the card details from your consent matches their data. If this does not match, we will contact you requesting clarification of your card number with the details provided for ID verification.
You can change your consent to the study and your permission to the research team to access your past loyalty card data at any time by contacting us directly at email@example.com or contacting the principal investigator, Dr James Flanagan. Please do not share any sensitive information over email (e.g. your date of birth).
Advised by data protection specialists based at Imperial College London, we designed this project around a robust data security model aiming to protect sensitive personal and medical data from the potential risk of unauthorised access or distribution. These are the measures we took to ensure that your data is processed fairly and securely:
i. The data will be analysed in a secure environment with access limited to the research team. No one other than the research team listed on this document will have access to the research dataset. All data will be stored and processed in the College’s ISO27001 certified secure environment – the “Secure Enclave”. This is a fully managed infrastructure and secure environment providing high availability, resilience and business continuity through multiple servers, back-ups and disaster recovery measures.
ii. We have strict data processing agreements in place with our commercial partners to ensure that your data is protected by us at all times. Your data will be transferred between the CLOCS team and the participating high street retailer using a secure encrypted file exchange. This means it will not be accessed by others.
iv. Under no circumstances will the retailers be aware of your health status. They will receive the consents of cases and controls combined and there will only be a single data transfer relating to your loyalty card purchases.
v. Our website server is based in the EU.
vi. Your purchase history data will be kept and analysed until the research is published, or 5 years from recruitment, whichever comes first. After this, any link to identifiable data will be destroyed and your data will be anonymised.
What are the possible disadvantages and risks of taking part?
There are no clear risks in taking part in this study. However, we understand that it may be emotional or distressing to think about cancer. If you are concerned about symptoms you are experiencing, please seek help and advice from health professionals. We intended to design the survey questions in the most sensible and sensitive way to ensure that there are no negative effects of this study on participants’ well-being. To our knowledge, this study is a unique project which could have important public health benefits for women. If the study is successful, this could be instrumental in raising cancer symptom awareness in commercial settings.
Who is organising and funding the research?
The study is being organised by the CLOCS study team and sponsored by Imperial College London. This research is being funded by a Cancer Research UK Early Detection Project Grant (C38463/A26726).
What will happen to the results of the research study?
The final study report will be produce summarising the information we have learned. All and only anonymised outputs from this project will be made publicly available on our website and in academic platforms, and will not include individual information. We will aim to publish outcomes in peer-reviewed academic journals and also on social media. If you are interested, please visit the CLOCS website for updates on the study’s progress and results.
What if something goes wrong?
If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for a 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 Investigator Dr James Flanagan (firstname.lastname@example.org). The normal National Health Service mechanisms are also available to you such as contacting the local Patient Advice Liaison Services (PALS; email@example.com, (020 3313 0088). If you are still not satisfied with the response, you may contact the Imperial College, Joint Research Compliance Office.
Who has reviewed the study?
IRAS Project ID: 262776
The study was first reviewed by patient representatives and edited accordingly. The project grant was reviewed by the Cancer Research UK Early Detection committee. This current study has also been reviewed and received favourable opinion by the North West - Greater Manchester South Research Ethics Committee (19/NW/0427).
You can contact the following support lines for information on ovarian cancer and support:
Ovarian Cancer Action
Call 0300 456 4700
Cancer Research UK
Call 0808 800 40 40
We really appreciate your help. Thank you for taking the time to read this Participant Information Sheet.
Dr James Flanagan
Ovarian Cancer Action Research Centre
Division of Cancer
Imperial College London