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CRN WM Privacy Notice March 2021

Contents

Privacy Notice – Clinical Research Network West Midlands

Clinical research is key to making advancements in patient care and as such, is a core activity for the NHS. It can also take place in other health and social care settings and beyond, for example in schools or prisons. Clinical research is an essential requirement to improve knowledge in understanding of which treatments work best. New and better treatments for many diseases would not have been possible without research.

The Clinical Research Network West Midlands (CRN WM) aims to ensure that all patients in the West Midlands are given the opportunity to participate in suitable research as part of their treatment and care choice from their Health and/ or Social Care provider. CRN WM forms part of a national infrastructure that supports all CRN Portfolio research* that has been approved by national Regulatory Authorities for example an independent ethics committee and the Health Research Authority.

The CRN WM is one of 15 local Clinical Research Networks in England which are part of the National Institute for Health Research (NIHR). CRN WM is hosted by Royal Wolverhampton NHS Trust whose Privacy Notice can be found at Royal Wolverhampton NHS Trust Privacy Notice.

* NIHR CRN Portfolio eligibility criteria can be found at Eligibility for NIHR Clinical Research Network support

The NIHR:

Funds, supports and delivers high quality research that benefits the NHS, public health and social care 

Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research

Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future

Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services

Partners with other public funders, charities and industry to maximise the value of research to patients and the economy

The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care.

Patient involvement in clinical research is vital. Patients can access health and social care services in a variety of ways, therefore the CRN WM works with a number of partner organisations to support research delivery (e.g. GPs, Hospitals, Care Homes, Pharmacies, etc) – please find a list of NHS Trusts and CCGs. For details of other partners, please contact crnwestmidlands@nihr.ac.uk.

What information do we collect about you?

CRN WM Communications

To allow us to support staff in our partner organisations to conduct research we collect, store and use their personal contact details such as name, postal address, email address, telephone numbers and in certain cases, details of training and/or qualifications where relevant. We also keep records of which sites are participating in research studies.

CRN WM Research

To manage patients who have expressed interest in a specific study, or are taking part in a research study we collect, store and use personal contact details such as name, email address, postal address, date of birth, gender and telephone numbers.

We may also collect, store and use the following special categories of more sensitive personal information e.g. Information about ethnicity, health and clinical history, results of investigations such as laboratory tests, other personal information such as smoking status and any learning disabilities, or religion. Not every study will require collection of all these categories of data; it will depend on the study protocol.

Patient and Public Involvement and Engagement (PPIE)

Patients and members of the public are invited to share their experiences of research with CRN WM. To enable us to document and share their experiences we may collect, store and use personal contact details such as name, email address, postal address, date of birth, gender and telephone numbers.

We may also collect, store and use the following special categories of more sensitive personal information e.g. Information about ethnicity, health and clinical history, results of investigations such as laboratory tests, other personal information such as smoking status and any learning disabilities, or religion. Experiences may include other personal information that the patient or member of the public wishes to disclose.

How do we use this and what is the legal basis?

CRN WM Communications

CRN WM processes personal data for the purposes of general communications with patients and partner organisations – the legal basis is GDPR Article 6 (1)(e)’…for the performance of a task carried out in the public interest or in the exercise of official authority….’

CRN WM Research

Prior to informed consent:
The legal basis which allows us to process your personal data for research is GDPR article 6 (1)(f) …legitimate interests…except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject…’

Once informed consent has been given:
The legal basis which allows us to process your personal data is informed consent - Article 6 1(a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes; and Article 9 (2) (a) the data subject has given explicit consent to the processing those personal data for one or more specified purposes.

Individual study consent forms will detail how to withdraw consent and who to contact, this will usually be via the study sponsor.

Patient & Public Involvement and Engagement (PPIE)

The legal basis which allows us to process your personal data is informed consent - Article 6 1(a) the data subject has given consent to the processing of his or her personal data for one or more specific purposes; and Article 9 (2) (a) the data subject has given explicit consent to the processing those personal data for one or more specified purposes.

For any queries in regards to consent for patient and public involvement please use the email address above.

Who do we share your information with?

CRN WM may need to share relevant personal information with other NHS organisations. For example, we may share your information for healthcare purposes with health authorities such as NHS England, Public Health England, other parts of the National Institute for Health Research infrastructure, Health Research Authority, other NHS trusts, general practitioners (GPs), ambulance services, primary care agencies, study sponsors.

We may need to share information from your health records with other non-NHS organisations from which you are also receiving care, such as Social Services or private care homes. However, we will not disclose any health information to third parties without your explicit consent unless there are circumstances, such as when the health or safety of others is at risk or where current legislation permits or requires it.

If you are a research participant, the specific patient information sheet (PIS) for the research you are participating in will explain how your information will be shared. CRN WM will be required to share information with study teams as stipulated in the PIS in order to answer the research question. In addition, any requirement to transfer your data internationally outside the UK, will be covered in the PIS
There are occasions where CRN WM is required by law to share information provided to us with other bodies responsible for auditing or administering public funds, in order to prevent and detect fraud.

There may also be situations where we are under a duty to share your information, due to a legal requirement. This includes, but is not limited to, disclosure under a court order, the Health & Safety Executive if you are involved in a reportable accident whilst on site, the police for the prevention or detection of crime or where there is an overriding public interest to prevent abuse or serious harm to others, and other relevant public bodies.

National Data Opt Out: How we use your information for purposes in addition to your individual care

CRN WM is working in the health and care system to improve care for patients and the public.

Whenever you use a health or care service, such as attending a GP appointment, important information about you is collected in a patient record for that service. Collecting this information helps to ensure you get the best possible care and treatment.

The information collected about you when you use these services can also be used and provided to other organisations for purposes beyond your individual care, for instance to help with improving the quality and standards of care provided, research into the development of new treatments, preventing illness and diseases, monitoring safety and planning services.

This may only take place when there is a clear legal basis to use this information. All these uses help to provide better health and care for you, your family and future generations. Confidential patient information about your health and care is only used like this where allowed by law.
Most of the time, anonymised data is used for research and planning so that you cannot be identified in which case your confidential patient information isn’t needed.

You have a choice about whether you want your confidential patient information to be used in this way. If you are happy with this use of information you do not need to do anything. If you do choose to opt out your confidential patient information will still be used to support your individual care. This is called the National Data Opt Out.

To find out more or to register your choice to opt out, please visit www.nhs.uk/your-nhs-data-matters. On this web page you will:

See what is meant by confidential patient information

Find examples of when confidential patient information is used for individual care and examples of when it is used for purposes beyond individual care

Find out more about the benefits of sharing data

Understand more about who uses the data

Find out how your data is protected

Be able to access the system to view, set or change your opt-out setting

Find the contact telephone number if you want to know any more or to set/change your opt-out by phone

See the situations where the opt-out will not apply

You can also find out more about how patient information is used at:

https://www.hra.nhs.uk/information-about-patients/ (which covers health and care research); and https://understandingpatientdata.org.uk/what-you-need-know (which covers how and why patient information is used, the safeguards and how decisions are made)

You can change your mind about your choice at any time.

Data being used or shared for purposes beyond individual care does not include your data being shared with insurance companies or used for marketing purposes and data would only be used in this way with your specific agreement.

Please note that the national opt out does not restrict members of your health care team contacting you to ask if you are interested in taking part in research.

Who and where do we obtain your information from?

CRN WM will collect data about you in a numbers of ways. The main method of collection is from you directly.

Face to face:
Most of the information we hold about you will be collected from you at the time you engage with us. Any data provided will be used for the reasons listed in this notice and only relevant data will be requested and recorded.

Telephone calls:
The information you disclose over a telephone call may be recorded by CRN WM either to support your care or as a record of the conversation. Ordinarily we will inform you if we record or monitor any telephone calls you make to the CRN WM. This is to increase your security, for our record keeping of the phone call and for training and quality purposes.

Emails:
If you email us we may keep a record of your contact and your email address for our record keeping

Other organisations:
We also work with a number of health and social care organisations whereby we could access information about you, for example; Hospitals, Care Homes, GP Surgeries, Community Hospitals, Prisons, Schools, Hospices and other settings where health and social care services are provided.

What rights do I have in relation to my information?

If we need to use your personal information for any reasons beyond those stated above, we will discuss this with you and ask for your explicit consent. The Data Protection Act 2018 gives you certain rights, including the right to:
- Request access to the personal data we hold about you
- Request the correction of inaccurate or incomplete information recorded
- Request the deletion of your data from our records

We will always try to keep your information confidential and only share information when absolutely necessary.

How do I request my information?

You have a right to see or have copies of any information held by CRN WM that relates to you free of charge. We have the right to charge an administration fee in situations where repeated requests are received for the same information or the request is excessive. You will be required to prove your identity when making requests.

Subject Access Requests under GDPR rules (post 25th May 2018) will be processed within 30 days. However, once our teams have established the volume of records requested there may be a requirement to extend this up to a further two months. We will contact you within 30 days should this be the case.

To request access to information CRN WM holds about you please email crnwestmidlands@nihr.ac.uk.

All our records are destroyed in accordance with the NHS Retention Schedule, which sets out the appropriate length of time each type of NHS records is retained. We do not keep your records for longer than necessary.

All records are destroyed confidentially once their retention period has been met, and the Trust has made the decision that the records are no longer required. For more information please see the Record Management Code for Practice for Health and Social Care 2016, retention schedules.

CRN WM Communications & Patient and Public Involvement and Engagement (PPIE)

Records Management Retention Schedules for Commutations:

Record Type

Retention Start

Retention Period

Intranet site 

Creation

6 years

Patient information leaflets

End of use

6 years

Press releases and important internal communications

Release Date

6 years

Public consultations

End of consultation

5 years

Website

Creation

6 years


CRN WM Research

Information will be held in line with specific research protocols. For clinical trials record retention please see the MHRA guidance at https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials

Records Management Retention Schedules for Research:

Record Type

Retention Start

Retention Period

Notes

Advance Medical Therapy Research Master File

Closure of research

30 years

See guidance at: https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing

Clinical Trials Master File of a trial authorised

under the European portal under Regulation

(EU) No 536/2014

Closure of trial

25 years

For details please see:

https://ec.europa.eu/health/human-use/clinical-trials/regulation_enJ.L_.2014.158.01.0001.01.ENG

European Commission Authorisation

(certificate or letter) to enable marketing and

sale within the EU member states area

Closure of trial

15 years

 

See guidance at: https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing

How to make a complaint

If you have any questions or a complaint in relation to GDPR, please email crnwestmidlands@nihr.ac.uk in the first instance. If you are not satisfied with the outcome, you can contact our Data Protection Officer who will investigate the matter further. rwh-tr.IG-Enquiries@nhs.net