The mission of the National Institute for Health Research (NIHR), the research arm of the NHS, is to maintain a health research system in which the NHS supports outstanding individuals, working in world class facilities, conducting leading edge research focused on the needs of patients and the public.

The NIHR is funded by the Department of Health

The Primary Care Research Network East of England (PCRN EoE) is one of a family of NIHR national research networks working together with theComprehensive Local Research Networks (CLRN) to provide a wide range of support to the local research community. Our Practice participates in research activity and works closely with the Primary Care Research Network East of England, creating more opportunities for more patients to be involved in research should they wish.

By building on and extending partnerships, with university academics and the NHS, research collaboration across the East of England is further strengthened.

The PCRN EoE also helps our practice by supporting us to recruit and take part in clinical studies through their locally based research nurses and network coordinators

What is Primary Care Research?

People use research to try and find the causes of diseases and to find better treatments and services for those diseases and improve patient care.

Research is presented in different formats;

• Completing a questionnaire
• Requesting the use of your anonymised data
• Taking part in an interview
• Testing new treatments, therapies or devices
• Experiencing new combinations of treatments.

Practice set up

We have been accredited by RCGP as ‘Research Ready’ so we are able to participate in research studies that PCRN EoE offers. To become research ready the practice has completed an online self-accreditation questionnaire which covers the minimum requirements of The Research Governance Framework for Health and Social Care, Department of Health (2005). The accreditation has been developed by the Royal College of General Practitioners in conjunction with the NIHR and the PCRN (Research Ready self-accreditation).

Benefits of being ‘Research Ready’

• Enables our practice to reflect on our ability and capacity to conduct high quality research
• Provides assurance for study sponsors, governance staff and patients that our Practice is up-to-date and compliant with national standards for NHS research
• Provides the practice with awareness of how it can minimise any potential risks for our practice, practice staff and study participants
• Access to a Research Ready file which provides a useful reference for the research team and also for the induction and training of new staff in our practice who will be participating in its research activities
• Opportunities to be involved in a wider range of research studies

Research Training

Good Clinical Practice for research in Primary Care

A key requirement for anyone involved in the conduct of clinical research is Good Clinical Practice for research (GCP) training. GCP is the guideline and standard to which all NHS research is conducted.

Why GCP training is essential

Everyone involved in the conduct of clinical research must have training to ensure they are best prepared to carry out their duties and responsibilities. This is laid down in the Research Governance Framework for Health and Social Care Department of Health (2005), covering all research in the NHS in England, and in law for those people working on clinical trials.

The principles of GCP state that: Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s). 2.8, E6 Guideline for Good Clinical Practice.

GCP Trained staff

Dr Kate Milne (GP)
Miss Tracey Bullard (Practice Manager)
Mrs Amanda Good (Healthcare Assistant)
Mrs Ceri Macalpine (Care Coordinator)

Practice involvement in research

Research studies help to answer specific questions about health and health care. For example;

• Whether new treatments or ways of organising services are effective (do they work?)
• Whether those treatments or services are cost-effective (do they give value for money?)
• How different health problems develop and progress over time – to help gain a better understanding of that health problem
• The views of patients and health professionals about a particular treatment, intervention or service and how they might be improved

The results of research studies can be of interest to patients and useful to health professionals and managers in the NHS in helping to decide what treatments and services to provide in future.

Studies our Practice have participated in

• Active Brains
• SAFER
• The STREAM trial
• Immune Defence
• Panoramic
• ATTACK
• And many more

Patient participation and how to take part in research

There are different ways that patients can become involved in studies our Practice is participating in:

• A doctor or nurse may talk to you about the study and ask whether you would consider taking part or
• You will be sent information through the post if we feel that you might be a suitable participant
• You may read information on the website about a current study and wish to take part by contacting the practice. You can find more information at: www.nihr.ac.uk/primary-care-research

Patients who express an interest in finding out more about a study will be asked for their permission to share their name and contact details with the study team. Some studies require direct contact between participants and the team, others involve contact through a member of practice staff or with a Primary Care Research Network research nurse.

• Participation in research is entirely voluntary and you have the right to say ‘No’. Nobody will put pressure on you to take part in research if you do not wish to. You do not have to give us a reason if you decide not to take part.
• Your care and your relationship with your doctor or nurse will not be affected in any way if you decide not to take part in a research study.
• You will always receive clear information about what taking part in a research study would involve. The practice will usually provide you with a patient information sheet; then, if you agree to take part, the study team will explain the study to you in more detail and you will have the opportunity to ask questions about it.
• Nobody from outside this practice will be given your contact details or have access to your medical records without your prior consent. 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 notes (if any) may be looked at for the purposes of the research.

You will not be asked to take part in a large number of studies. Most researchers are very specific about the criteria that people need to meet in order to enter their study. Usually this means that only a relatively small number of patients at the practice will be suitable for any one study.

Patient and Public Involvement (PPI) in Research

Information about how patients and members of the public can be involved in helping to influence the shape of research

Increasingly patients, carers and members of the public are contributing their perspectives to the way clinical research is designed, commissioned, managed and supported. Active involvement in clinical research is very different from being a participant in a study.

Members of the Practice Patient Group or others may be interested in how to get more involved:

www.crncc.nihr.ac.uk

European Patient Ambassador Programme (EPAP)

EPAP has been developed to help patients and carers across Europe understand how healthcare research and guidelines work, how to get involved and engage in advocacy and media activities at any level.

Research and patient experience short films

A number of short films can be found on the NIHR website. The video provides a personal insight into primary care research from the perspective of both the researcher and participant.

Healthtalk

An award winning charity website allowing patients and the public to share experiences of health and illness and taking part in research studies:

www.healthtalk.org

NHS choices

Comprehensive information about research for patients and the public:

www.nhs.uk/Conditions/Clinical-trials

Clinical trial participants: guinea pigs or informed volunteers?

The article, by a Guardian journalist, uses the patient’s perspective to address some of the common myths and misunderstandings about clinical research.

It explains how volunteers involved in clinical trials are not human guinea pigs, but patients taking an active role in their healthcare, aiming to improve the quality of life for others with similar health conditions.

www.crncc.nihr.ac.uk

Finding a research study to take part in

UK Clinical Trials Gateway (UKCTG)

The UK Clinical Trials Gateway provides easy to understand information about clinical research trials running in the UK, and gives you and others access to a large range of information about these trials. It is designed to enable you and your clinician to locate and contact trials of interest to you.

Have you ever thought about taking part in research?

Research is taking place all the time in the NHS – in hospitals, clinics and in the community. This leaflet explains why you or your family or carers may be asked to be involved in research and explains why research is done.

Why do we carry out research?

Research:

• Helps us to identify and provide the best possible care for you, your family and community.
• Looks at ways to help prevent illness, and helps us to improve treatments and services, making sure they are safe and effective and make the best use of resources.
• Can increase our knowledge about illnesses and help us to find out what it is like for you to live with a condition.
• Helps us to find out what you and others think about the services you receive.

Information we get from research may also be used to help us:

• Teach and train our staff.
• Plan for the future.
• Improve the NHS.
• Compare ourselves with the rest of the country.

How can you help?

Research cannot happen without your help. Taking part in a project may not always help you directly, but you will be helping to develop services and treatments for future generations.

If you are asked to take part in a research project, please consider getting involved.

What you will be asked to do will depend on the project; however it may involve:

• Filling in questionnaires.
• Talking to the researcher about your views.
• Letting the researcher look at your medical notes.
• Trying a new treatment or drug.

If you are asked to take part in research:

• Your care will not be affected if you decide not to take part, or if you say yes and then change your mind.
• Your doctor, nurse or researcher will explain what the project is about and what is involved in taking part. They will give you some written information about the project for you to keep.
• You will be given time to think about all the information and to ask questions. If you don’t understand anything, please ask. You should only say yes if you fully understand what will be involved and are happy with this.
• If you decide to take part you will be asked to sign a consent form and will be given a copy to keep.

Remember:

• Taking part in research is voluntary. You do not have to take part and you can change your mind at any time – you do not need to give a reason.

Before a research project starts it is looked at by various organisations to make sure it is OK for you to take part. These include an NHS Research Ethics Committee and the NHS organisation responsible for your care. They make sure that any risks have been looked at, that the study is of value to patients and the NHS, and that it respects the rights, safety and wellbeing of those taking part.

They also review projects regularly after they have started to make sure they continue to be safe.

Can you be identified?

• No researcher will be given access to your health records for research without your consent.
• Where possible all data collected from you for research purposes will be coded with a number rather than your name.
• Everyone who has access to your records, or any of your details for research, is bound by a strict code of conduct to keep your data confidential.