Introduction

Your practice is involved in medical research and from time to time you may be approached to take part. Taking part in research is voluntary: you can freely accept or decline, and this will not affect the care that you receive in any way. Even if you agree to take part, you can still withdraw at any time, without having to provide justification. Withdrawing from a study will NOT affect the care we provide for you.

All research projects carried out at The Boathouse Surgery has been thoroughly checked and approved by the relevant health authorities & ethical committees ensuring it is appropriate and safe to perform. You will always receive clear information about what taking part in a research study would involve and will have the opportunity to ask questions and obtain further details about a study. All projects are fully compliant with all UK laws (incl. GDPR).

• You may receive a letter in the post offering you the opportunity to take part in a study (the letter will include some information about the project). Although the letter will often say it is from the study team, we would never share your personal data without your consent. All mailouts are in fact done by your practice and your address (as well as any other personal data) has not been shared with anyone else.
• Your doctor or nurse may also offer you to take part in a study during your usual appointment.
• You may also be approached by a member of the study team in the waiting area; be assured that this person and their activity will have been approved by the practice.

What you will be asked to do as part of the research will vary from study to study. The Patient Information Sheet for each project will detail what is expected of you. The study team is also there to answer all questions you may have.

You can choose whether your data is used for research or planning purposes, and can find out more information about this here:

• www.nhs.uk/your-nhs-data-matters.

If you have any questions or wish to opt-out of receiving information relating to research, please contact Vicky Anderson (vicky.anderson@nhs.net)

Research in the NHS in collaboration with the National Institute for Health Research (NIHR)

The NHS is committed to the innovation, and to the promotion, conduct and use of research to improve the current and future health and care of the population

Clinical Research is a major driver of innovation and central to NHS practice for maintaining and developing high standards of patient care. Participating in Clinical research allows patients to get access to new interventions, treatments and medicines. Ultimately, investment in research means better and more cost-effective care for patients.

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research and provide the people, facilities and technology that enables research to thrive. Working in partnership with the NHS, universities, local government, other research funders, patients and the public, they deliver and enable world-class research that transforms people’s lives, promotes economic growth and advances science.

The Boathouse Surgery is part of a network of local practices participating in research activities under the banner of NIHR Clinical Research Network: Thames Valley and South Midlands (NIHR CRN TVSM). The CRN TVSM is hosted by Oxford University Hospitals NHS Foundation Trust and covers Berkshire, Buckinghamshire, Milton Keynes and Oxfordshire.

To find out more about the work of the CRN TVSM, go to www.crn.nihr.ac.uk

Support for Primary Care Research

The National Institute for Health Research works with researchers and primary care practitioners such as GPs, practice nurses, pharmacists and dentists to promote the successful delivery of research studies in the NHS. We support a wide range of research including studies which look at:

• Promoting a healthier lifestyle
• Disease diagnosis and prevention
• Management of long-term illnesses such as diabetes or hypertension
• Prevention of future ill-health
• Treating common conditions such as tonsillitis or influenza

Following GDPR guidelines and ensuring your data is protected

If you do agree to take part in a study, you will be asked to sign a consent form. This will clearly state which parts of your medical notes (if any) may be looked at for the purposes of the research study. Nobody from outside your practice organisation will be given your contact details or have access to your medical records without your prior consent.

Use of third-party document outsource processors (mailing companies)

Researchers regularly use document outsource processors such as Docmail* to send study information to people who might be interested in taking part in clinical research. Only companies that are confirmed as being fully compliant with the laws surrounding data protection and data sharing, such as GDPR, are used. In addition to this, providers will be reviewed and permitted by the regulatory bodies that ethically approve, govern, and oversee clinical research taking place in the UK, such as the NHS Health Research Authority and Research Ethics Committees.

• www.cfhdocmail.com

We would like to reassure you that, should you receive an invite to participate in a research study:

• The letter will have come directly from the practice. We do not share identifiable information with researchers without patient consent.
• It is our practice staff who perform research mailouts using the document outsource processor. Your contact details will not be shared outside of the system and will be deleted after 28 days.

Practice collaboration with research data registries

We are part of Clinical Practice Research Datalink which means that we contribute de-identified data to CPRD (Clinical Practice Research Datalink) for public health research. CPRD is a real-world research service supporting retrospective and prospective public health and clinical studies and is jointly sponsored by the Medicines and Healthcare products Regulatory Agency and the National Institute for Health Research (NIHR), as part of the Department of Health and Social Care.

Individual patients cannot be identified from this information (www.cprd.com/safeguarding-data), but you are able to opt out if you prefer. Protecting the confidentiality of patient data is paramount, and only anonymised patient data is provided to researchers

We are part of the Royal College of General Practitioners (RCGP) Research Surveillance Centre (RSC) which means that we contribute de-identified data to the RSC for public health research.  The RSC is an active research and surveillance unit that collects and monitors data, in particular Influenza, from practices across England.

Individual patients cannot be identified from this information (www.rcgp.org.uk/terms-and-conditions/data-protection-policy).

What are the benefits of your practice being active in research?

Evidence suggests that patients who receive care in research-active institutions have better health outcomes than those who are treated in a non-research environment.

By joining the research community, we are actively helping to improve the standard of healthcare for our patients.

Research provides an opportunity for you, the patient, to better understand your health conditions as well as give something back to the NHS and wider community.

Sometimes it can provide patients with access to new treatments, as well as bringing a new dimension to practice and added skills to those involved.

The practice will receive funding to cover any additional costs of taking part in research (it does not come out of our own budget and so routine patient services will not be affected).

PATIENT PERSPECTIVE: Is research right for me & what do patients taking part in research really think?

Ultimately, our research helps people to access and take part in studies which could potentially make a real difference to their health conditions and quality of life. Click on the links below to hear more from patients who have taken part in research: Click on the links to find out more information:

Health talk:

• http://www.healthtalk.org/peoples-experiences/medical-research

Clinical Research Network – Patient Research Experience Survey:

• https://sites.google.com/nihr.ac.uk/tvsmpres/home

Here are a few quotes from patients who took part in the 2018/19 Patient Research Experience Survey, explaining why they took part in research and how they feel it has benefited them:

• “I felt being part of the research helped my case, maybe got treatments that I would not have had otherwise”
• “I do feel as though I’m contributing to the improved care for future generations”
• “With the close monitoring / treatments from everyone, I now feel a lot healthier”
• “The process has made me much more aware of my condition and that advice and care was immediately available”

How can you get involved?

Find out what studies are available in your area and at this practice. Use the map below to find research studies taking place in the NHS, public health and in which you could take part in. Some studies will be for people with a specific medical condition while some will be seeking healthy people too.

Geomap: https://sites.google.com/a/nihr.ac.uk/crn-tvsm-portfolio-info/

• You may read information about a current study in the patient waiting room or on the surgery website and wish to take part.
• Many practices have a lead Research GP or nurse. Ask your GP / nurse during your next visit or you may be able to email your practice for more information.
• You could join specific research organisations such as Join Dementia Research (https://www.joindementiaresearch.nihr.ac.uk/).

Here are some of our actively recruiting studies:

COAT

Aim to assess whether lower limb cellulitis can safely be treated with a 5-day course of antibiotics vs. placebo.
https://www.southampton.ac.uk/ctu/coat-study.page

DISCOVER-ME

The study aims to create a dynamic resource of demographic, health and genetic data to enable analyses to understand clinical disease progression in primary care and risk prediction.
https://www.discovermestudy.com/

GUTBRAIN

Testing how bacteria in the gut can influence our brain and behaviour.
https://www.reading.ac.uk/hsuhn/volunteer/gut-brain-study

PETRUSHKA

Assess whether the PETRUSHKA tool can help to personalise treatment for people with depression and predict which antidepressant works best for each individual vs. usual care in the NHS.
https://www.psych.ox.ac.uk/research/evidence-based-mental-health/petrushka-trial

T2T

What is the clinical and cost effectiveness of using a goal-directed allopurinol-based treat-to-target protocol in people with recurrent gout flares?
https://www.keele.ac.uk/ctu/researchportfolio/activeresearch/t2t/#!

RESTED

Trial of sleep restriction therapy to ease depression.
https://www.phc.ox.ac.uk/research/institutes-units/phctrials/trial-portfolio/randomised-evaluation-of-sleep-treatment-to-ease-depression-rested

DARE2THINK

DaRe2THINK aims to determine whether direct oral anticoagulant (DOAC) therapy reduces premature death, stroke and other thromboembolic consequences of atrial fibrillation in younger patients, including prevention of cognitive decline and vascular dementia.
https://www.birmingham.ac.uk/research/cardiovascular-sciences/research/dare2think/index.aspx

TIGER

Trial of food allergy (IgE) tests for eczema relief in under two year olds.
https://tiger.blogs.bristol.ac.uk/

Frequently Asked Questions/FAQs

• Q: Do I have to take part in a research study if my GP offers me to?

A: No. Participation in research is entirely voluntary. Choosing not to take part will not affect your future medical care or your statutory rights in any way. If you do choose to take part in a study you will be free to withdraw at any stage, if you decide you no longer wish to continue. You do not have to tell the reason for your decision if you do not wish to do so.

• Q: Is it safe for me to take part in a study? Can I be sure that the study was reviewed thoroughly?

A: Yes. All research in the UK is reviewed by independent bodies incl. a Research Ethics Committee (REC) and the Medicines and Healthcare products Regulatory Agency (MHRA) (for research involving new drugs and therapies).

• Q: Will taking part in research affect my Travel Insurance?

A: In Feb 2019 the Association of British Insurers (ABI) agreed that taking part in a clinical trial should not affect travel insurance cover if the medical condition in question doesn’t.