BEA study

PRIVACY INFORMATION

How we use your personal information

1. Background
2. Study information and findings
3. What information the research collects about you
4. Your rights
5. Protecting your data
6. Contacts for further information

1. Background

Background

The Manchester University NHS Foundation Trust is required to inform people about the ways in which we use their personal information. We need to tell you about the types of personal information we collect, the purposes we use it for, the legal reasons contained in the General Data Protection Regulation and Data Protection Act 2018 which allows us to use it in these ways, how long we retain the information for and how you can exercise your rights.

This requirement applies when dealing with “personal data”. If data is considered personal then the GDPR places specific legal obligations on the controller of that data. If data is not personal (i.e. if it never related to a person or if it has since been anonymised) then the GDPR does not apply.

Manchester University NHS Foundation Trust is the Data Controller for the BEA study (Multifrequency Bioimpedance in the Early Detection of Lymphoedema). This means that we will decide how your personal information, as a participant in the BEA study, is created, collected, used, shared, archived and deleted (processed). When we do this we will ensure that we collect only what is necessary for the project. If any other organisation will make decisions about your information, this will be made clear in the participant information sheet provided to you when you agreed to participate.

Access to patient data is vital for this the BEA study and we implement high security and governance standards to ensure patient confidentiality within our study. We obtain appropriate ethical and legal approvals for all research and ensures that it is strictly in the public interest when we use personal information. We do this by following the UK Policy Framework for Health and Social Care Research.  Further information can be found here: https://research.cmft.nhs.uk/getting-involved/gdpr-and-research.

2. Study Information and findings

What is the study?

Arm swelling can occur when axillary lymph nodes in the arm pit are removed during breast cancer surgery. Arm swelling is a result of fluid building up in the tissues. Arm swelling may happen immediately after surgery and/or chemotherapy, and/or radiotherapy or it can happen in the years following. The swelling may be accompanied by numbness, discomfort and sometimes in extreme cases can lead to infection. The nodes and lymph vessels that have been removed cannot be replaced.

Arm swelling can occur in some women after surgery, although it may not happen to all women. This can lead to reduced arm movement and have a negative impact on the quality of life after breast cancer surgery.  Arm swelling is a long-term condition, which means that it can be controlled but it will never go away. A recent study in the USA indicated that you have more chance of developing arm swelling if you have had anthracycline chemotherapy and/or radiotherapy after surgery. Arm swelling is difficult to treat if not detected early; therefore prevention through regular monitoring and early detection would be a better and more cost effective strategy.

Traditionally, arm circumference volume is measured to detect early swelling. We wanted to determine whether the change in arm sizes in the operated arm will tell us which patients will develop arm swelling / Lymphoedema at two years.  The trial aimed to predict who will get arm swelling at two years, so that it would then be possible to use early intervention with compression sleeves to prevent the development of arm swelling at a later stage. The trial showed Lymphoedema develops after axillary clearance (ANC) in 20-25% patients. Since the study has finished, we have lost follow-up data due to patient deaths or patients moving away.  The patient cohort are aware of the need for further follow-up as stated on the Participant Information  Sheet and consent forms signed by those who have taken part in the study.

Findings in BEA Study

Lymphoedema was diagnosed in 22·8% women by arm volume increases of greater than 10%, in 45·6% women by Bioimpedance criteria and 24·5% patients underwent compression sleeve application.

High Body Mass Index>30 (being obese) was an independent risk factor for both development and progression of Lymphoedema. Arm Volume Increases at 1 month, BMI>30 and the number of involved nodes were used to develop a novel scoring model to predict Lymphoedema by 36 months.

The study showed; Lymphoedema by 9 months, number of involved nodes, tumour grade and size and oestrogen receptor status were independent predictors of distant disease-free cancer survival. BMI>30 predicted Lymphoedema diagnosis, progression and poorer breast cancer survival.

We wish to determine the effects of these independent factors found during the study from a longer follow-up period of 5 years to determine further Lymphoedema and cancer progression.

3. What information the research collects about you

Following your consent to take part in the study, information on your breast cancer diagnosis and treatment, including pathology information and data on any hospital admissions during your treatment and follow-up care, has been collected for the purposes of the study. Relevant sections of your medical records have been used to collect this information.  Your GP will have been informed of your participation in the study and, in some instances, your GP will have been contacted by the study team to collect further medical information regarding your breast cancer care.  In order to access this information, personal data such as NHS numbers, names and dates of birth will have been used.  This information is kept strictly confidential and stored in a secure area of the MFT NHS Trust, as detailed in the Patient Information Sheet.

We process personal information about BEA participants (which includes your name, address, date of birth and information about your health and treatment) from the following sources:

• Directly from you with your consent (such as questionnaires and study visits to the hospital)
• From your doctors and/or medical notes (in the hospital you received your care and your GP)
• From third-party sources (e.g. NHS organisations, disease registries, other research institutions, NHS Digital, Office for National Statistics) with your consent or, under exceptional circumstances (where consent is not possible), with relevant approval from the Health Research Authority (HRA) to do so.

We would like to maintain follow-up of patients who took part in the study and have HRA approval to do so. The NHS Trust will use the data collected for the BEA study to link with national NHS databases via Public Health England (PHE) to collect any missing data relating to your breast cancer treatment and ongoing care.  To enable us to access medical records from Public Health England we will use either the NHS number, or date of birth along with demographic information (name and address) to obtain the NHS number through the Personal Demographic Service (https://digital.nhs.uk/Demographics). We will then share the NHS numbers with the National Cancer Registration and Analysis Service – based at Public Health England (http://www.ncras.nhs.uk/) to link with information held by these bodies. The cancer registry holds information on cancer diagnoses, hospital attendances and admissions, treatment information/medication, other illnesses and survival data.  Pseudoanonymised linkage will then be provided back to the NHS Trust from PHE.  This means that once your data has been linked to the PHE databases using your NHS number/Date of birth/name, your personal information will then be removed and replaced by your study identification number.  This data will then be transferred to the University of Manchester, acting as the data processor for the study, in pseudoanonymised form.  This will ensure that no identifiable data is used in the analysis and write up of findings or results.  The data will not be transferred outside the European Economic Area.

4. Your rights – BEA’s lawful basis for processing your data

By law you have rights in relation to the personal information we hold about you. These include the right to:

• See the information/receive a copy of the information;
• Correct any inaccurate information;
• Have any information deleted;
• Limit or raise concerns to our processing of the information;
• Move your information (“portability”).

A legal requirement of the GDPR is that we tell you about the legal basis on which BEA will process your personal data. As part of the Trust’s public task, we undertake important health and care research. As a public body, our lawful basis for processing data for research purposes is a task in the public interest.

Because of the health-related nature of the personal information that you have provided to us, there are two lawful bases for our processing of it, which are referred to in the legislation as ‘public interests’ and ‘special category’.  BEA believes that both of these are valid reasons for processing your data and, as is required by the law, we have set our reasoning below.

Article 6.1.e

For research, the legal reason falls under the ‘public  interests’ condition of the GDPR, as the research is being conducted by a public authority (the NHS Trust) and is part of a public task. This task will have a minimal privacy impact as the data will be anonymous after linkage, and there is a great potential impact on patient benefit in cancer patients as well as societal benefits.

https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/public-task/

Article 9.2.j

For sensitive information, the projects aim meets item 9.2.j ‘special category’ detailed in Article 9 of the GDPR.

Processing this data is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. Firstly, the linkage will allow us to collect missing data that was lost to follow-up for the trial which will ensure a fully saturated dataset for analysis. Secondly, we will be able to validate our own data and ensure NHS databases are correct. Finally, we will then be able to link trends such as deprivation and other comorbidities with the original dataset which will give us other means of analysis for the data within the trial. This linkage will also benefit cancer patients both locally and nationally. The linkage of these datasets identifies with the purposes in accordance with Article 89(1) which would be processed for substantial public interest in improving breast cancer care nationally through research purposes and statistical analysis.

https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/special-category-data/

The study has also sought special permission under Section 251 (of the NHS Act 2006) to access data from your medical records that is processed by the Public Health England National Cancer Registration and Analysis Service (NCRAS; the population cancer registry in England). Section 251 enables the common law duty of confidentiality to be lifted to enable disclosure of confidential patient information for medical purposes, where it was not possible to use anonymised information and where seeking consent was not practical. For information about the CAG and Section 251, please visit the Health Research Authority website.  This permission allows the BEA study to share your NHS number and date of birth with NCRAS so that the study can find out if your breast cancer has returned, spread to other parts of your body and what care you have received from the NHS since participating in the BEA.  All data shared with NCRAS is treated in the strictest confidence.

You can learn more about NCRAS and how the cancer registry collects data here: https://www.ndrs.nhs.uk/

5. Protecting your data

Storage and access of Data

All research conducted at the Trust is approved by the Health Research Authority who assess that it is compliant with UK law and regulations, including where required, an NHS Research Ethics Committee review. Research initiated and sponsored by the Trust is assessed to ensure it meets current regulations.

BEA stores all study data securely and to the highest industry and professional standards within the protection of the Manchester Clinical Trials Unit (MCTU) at the University of Manchester, which acts as the Data Processor for this study.

Only the BEA study team at Manchester University Foundation Trust have access to participants’ personal identifiers, as the Trust acts as Data Custodian and Data Controller as the Study Sponsor. This is secured through the NHS Trust.  The sensitivity of patient information is well understood within the NHS. Our staff are required to undertake annual training on their duty of confidentiality and data protection, and responsibilities are written into employee’s contracts.

All MFT staff have their own unique logon credentials (username / password) for accessing Trust systems; and can only access those Trust systems necessary for their job role. Within the individual system, their access is also in line with the individual’s job role. This ensures confidential data is on a “need to know” basis.

We will undertake a Data Protection Impact Assessment (DPIA) where necessary, for example at the start of any major new project that involves the use of personal data or introduces new technologies.

We do not routinely transfer any information to countries outside the UK. If your information is to be sent outside of the European Economic Area we will undertake a DPIA to ensure transfer is in accordance with Data Protection legislation and any identified risk is mitigated.

Retention of Data

BEA will store participants’ data for 15 years. The BEA study is a long-term study and participants’ data will be kept for the duration of the project as set out in the consent provided by each participant.

6. Contacts for further information

Participants have the right to contact the UK’s data protection authority – the Information Commissioner’s Office (https://ico.org.uk/) – if they have any concerns about BEA’s use of personal data and/or the approach to data protection and the GDPR.

Patients have the right to withdraw from the study at any time. To discuss withdrawal options, please contact Programme Coordinator Donna Watterson on 0161 291 4045 representing the Sponsor site of the study (Manchester University Foundation Trust).

Data Controller – Manchester University NHS Foundation Trust

Data Custodian – Manchester University NHS Foundation Trust

Caldicott Guardian for MFT – Professor Jane Eddleston

Information Asset Owner – Dr Max Pilotti, Manchester University NHS Foundation Trust

Data Processor –Manchester Clinical Trials Unit, The University of Manchester