There are many benefits to getting involved in research and there are different levels of involvement, meaning you can get involved in a way that suits you.

The Clinical Research Network is currently working with healthcare professionals all over England who, along with their patients, are actively benefiting from taking part in clinical research. Ultimately, clinical research means patients get access to new treatments, interventions and medicines, and investment in research means better, more cost-effective patient care. In a recent survey by the CRN, 95% of people said it is important to them that the NHS carries out clinical research.

A recent Royal College of Physicians report states: 

“There are two things that make doctors uniquely well placed to contribute to research and ensure medical advances are patient centred. First, their regular clinical contact with patients makes them uniquely able to observe patterns and identify the research needs that make the most difference to patients. Second, their understanding of what is realistically translatable into day-to-day practice enables research findings to be disseminated and implemented in ways that make a difference for people. It is essential, therefore, to ensure that doctors remain involved in research at all levels.”

“In [our current] context, research must not be seen as a nice-to-have luxury for times of less pressure. On the contrary, it underscores the urgency with which we should be seeking innovative solutions that will let us efficiently care for more patients to ever higher standards – solutions that will only be found through investing in medical and quality improvement research.”​

You can read more about engaging in research - how and why - at the following links: 

Approximately 1000 practices in the UK, around an eighth of the all GP practices, are Research Ready. If you are ready to get involved in research, click on the following link to find out more. Becoming accredited as Research Ready also entitles you to free access to the RCGP Research Ready e-learning package for the whole team.

I have an idea for a research study
I would like to get involved in a research study
I have been approached by a researcher about a study
I am interested in learning about the outcomes of research

 

RCGP has an initiative, working together with NIHR to identify areas for research. To contribute to this, and influence research from a primary care perspective, see this link.

If you are interested in developing your own study, please read here.

What do I need to know about the research governance process?

You can read more about opportunities for GPs in research here.

 

There are a number of ways you can get involved in research – each with different levels of involvement.

Open Studies

What studies are going on in my area?

To find out about studies which are going on in your area you can contact us at research@bradford.nhs.uk.

Here we have provided information about studies that are currently open across West Yorkshire and Harrogate.  Please note that some studies may be specific to a particular Clinical Commissioning Group (CCG) or may not currently be recruiting new practices, so please email us if you require further information.

For more information on each study please follow the links:

Yorkshire Lung Screening Trial

Yorkshire Cancer Research have funded a £5.2m study pilot community-based lung cancer screening in Leeds. The study aims to invite about 30,000 people for a ‘Lung Health Check’ assessment, with 7,000 expected to attend mobile vans in supermarket car parks for a screening CT scan.

Expressions of Interest from practices in Leeds are currently being sought.

How do GPs explain their information sharing behaviours
There are several circumstances in which GPs are asked or expected to share information about their patients, for example with clinical colleagues, with other services, with health managers and with researchers. This work aims to describe how GPs share information with others and the explanations they give for that data sharing.

ABACus – Awareness and Beliefs About Cancer

Cancer survival rates are lower in disadvantages communities, possibly due to low awareness of symptoms and delayed help-seeking. It is important that people increase their knowledge of cancer symptoms, so that they know when to seek medical advice and therefore possible detecting cancer earlier. The study team have developed an interactive online health check questionnaire to be delivered in these communities.

Barriers and Facilitators to Deprescribing in Care Homes
An investigation into the barriers and facilitators to stopping inappropriate medicines (“deprescribing”) for older people living in care homes to inform the development of a novel intervention.     

CARE 75+ 
Community Ageing Research. Establishing a cohort of older people for observational research.

No further practices needed at present.

EMPRESS
Cancer diagnosis via emergency presentation.

A quarter of patients with cancer are initially diagnosed during an emergency presentation to hospital. The study team are interested in understanding what contact patients have in primary care the year before their cancer diagnosis, to determine whether there are ways in which to reduce the number of emergency presentations.

ETNA-AF-Europe 
Non-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation.

No further practices needed at present.

EXPERT
Views and experiences of penicillin allergy testing.

GP attitudes towards asking women routinely about domestic abuse

Professionals working in mental health and midwifery services are required to ask female patients routinely if they are experiencing domestic about and whilst research indicates that women will access their GP as a result of abuse suffered the practice of routine enquiry by GPs has not been consistently adopted. This study will explore GP experiences and attitudes towards asking female patients routinely about domestic abuse during an appointment.

The HEARTH Study
Delivering primary health care to homeless people: an evaluation of the integration, effectiveness and costs of different models.

ISCOMAT WP3

Improving the safety and continuity of medicines management transitions.

When a patient moves (e.g. from hospital to home) medicine problems are common and planned changes are not always followed through. This study will test the feasibility of an intervention to improve the use of prescribed medicines when patients move.  

Lifestyle Health and Wellbeing Survey

A programme of research aimed at improving the health and wellbeing of people who use mental health services.

OPAL
Oxford Pain, Activity and Lifestyle Study. The OPAL study looks at how people's health and physical activity change over time. 

No further practices needed at present.

QualDash: Designing and evaluating an interactive dashboard to improve quality of care

Physical healthcare needs of people with serious mental illness

This study will look at people with a serious mental illness and explore patients’ and general practice clinicians’ experiences of looking after the physical health of people with serious mental illness. This will improve our understanding about the challenges faced in accessing and providing care.

Self-management support for patients with long term conditions in primary care

The study team want to understand how equipped GP practices are at supporting patients in managing their condition and treatment. By finding out what currently happens in routine practice and work with practices to develop recommendations for a practitioner tool-kit that can be used in supporting patient self-management in primary care.

A study of common and rare genetic variants associated with thinness

Identification of genes that contribute to thinness may provide further insights into the regulation of body weight and obesity resistance. Understanding the genetic basis of thinness requires a substantial cohort of thin people who are otherwise well.

UKAGS
The United Kingdom Aneurysm Growth Study. Aims to find out more about abdominal aortic aneurysms.

Understanding variations in referral decisions in primary care
Investigating delays in the detection of early cancers within primary care, an exploration of GPs’ decision making based on Signal Detection Theory

VACCEPT
Survey to explore the acceptability of vaccination and knowledge of HPV in women aged 30 to 45 years attending for cervical screening.

No further practices needed at present.

2WW
Two Week Wait. An investigation of patient non-attendance at urgent referral appointments for suspected cancer.

 

Trials Closed to Recruitment

Where possible we try to feedback results of studies that our primary care practitioners and their patients have become involved in. Further results will be added as and when they become available.

ASPIRE Action to Support Practices Implement Research Evidence - a trial aiming to develop and test ways to support general practices in implementing evidence-based practice effectively and realistically within the constraints and challenges of real-life general practice.

CAP Trial - Diagnosis and management of prostate disease in the UK.

CADPC II Children with Anxiety Disorders in Primary Care: the views of General Practitioners - interviews were held with GPs from a variety of locations in England, discussing their experience of managing childhood anxiety disorders.

CANDID - Cancer Diagnosis Decision Rules. This research is about finding what symptoms and examinations are best for predicting lung and bowel cancer. 

Cervical Screening Study - The views and experiences of patients and practitioners regarding cervical screening amongst women (55-64 years old) across Yorkshire and Humber - a qualitative study investigating attitudes towards cervical cancer screening.

CHIPPS Work Programme 5 - Care Homes Independent Pharmacist Prescribing Service - work package 5.

Effect of bioactive enriched food on markers of metabolic syndrome
Pivotal assessment of the effects of bioactives on health and wellbeing. From human genoma to food industry - PATHWAY-27.

Factors affecting patients' use of electronic personal health records

FFLU-X study - A guideline approach to therapy step-down utilising Flutiform®: change and step-down. The aim of this study was to compare two licensed asthma inhalers and to then evaluate the safety of reducing treatment when patient’s asthma is in control.

HEAT - Helicobacter Eradication Aspirin Trial.

HEP FREE Chronic viral hepatitis in ethnic minorities: a controlled randomised cross sectional cluster trial to assess the impact of identifying, screening and treating immigrants with viral hepatitis - to assess the most cost effective method of screening for chronic viral hepatitis in primary care patients within ‘at risk’ groups.

Mother to infant attachment and body image in the postpartum period -This is a maternal mental health study which is exploring the relationship between the way a mother feels about her body and the bond she experiences with her baby.

Organising general practice for care homes: Qualitative interviews

Partners At Care Transitions (PACT) Understanding excellence from a general practice perspective – Focus groups will be conducted in each high performing general practice to identify the factors that facilitate lower rates of re-admission.

PRESENT The Predisposition to Serrated Neoplasia and Tumours (PRESENT) study - to identify genetic factors (genes) involved in susceptibility to and the development of serrated polyps and cancers of the large bowel.

Q Method study - Primary Care Professionals’ views on depression case finding.

REACT  - Relatives Education & Coping Toolkit. An online study to compare the effectiveness of a Relatives Education And Coping Toolkit (REACT) with an online resource directory.

River Registry - RIVaroxaban Evaluation in Real Life Setting – a large global disease registry focusing on studying Atrial Fibrillation, looking at patients with newly diagnoses AF, with at least one additional risk factor for stroke, and treated with Rivaroxaban.

Tele-first - Telephone triage as an alternative to face to face contact in general practice - to explore how a GP telephone triage affects patient experience and use of NHS primary and secondary care services.

TIME Treatment In Morning versus Evening - a trial comparing evening dosing of usual antihypertensive therapy with conventional morning dosing.

TUDOR - Total Burden of Psoriasis - to find out whether diagnosing psoriasis related health complications earlier leads to an improvement in physical health.

Understanding the impact of the introduction of NHS new models of care and locality based working on frontline staff - this research has been commissioned by Leeds West CCG and has been designed to evaluate if there are improved relationships between frontline staff working in different organisations through the establishment of the Community Wellbeing Leadership Team.

WellGP - Daily diary study exploring GP wellbeing and patient safety - the study aimed to explore the nature of the relationships between burnout, wellbeing and patient safety, using a daily diary methodology.

Ways to Get Involved
Ways to get involved in research studies
  • Recruiting patients to a study

  • Carrying out research activity at your site (which can be anything from consenting patients to carrying out medical procedures, questionnaires etc.)

  • Working with others to support a study

If you already know the study you want to be involved in, click here to contact the team to find out how.

Recruiting patients

Some studies recruit patients through general practice but the research activity takes place in another setting, e.g. hospital.

These are known as PIC (Participant Identification Centre) studies, which means the study team does not have permission to carry out research activity in general practice but general practices can be involved by recruiting patients. This can involve all or some of the following:

  • Conducting a search of your database to identify a list of participants which fit a study’s inclusion/exclusion criteria

  • Sending out a letter to patients to introduce the study, or providing the list of eligible patients so that the study team can send out the letter

  • Introducing the study to eligible patients who come into your practice and meet the criteria; this could be that a patient comes in and is diagnosed with the relevant condition, which leads to them being eligible

If the study requires the health care professional to consent patients or carry out any other research activity, including consenting patients, then it is a full research study and not a PIC

Research activity at your site

Other studies involve conducting some of the research in primary care, which could mean, for example:

  • Consenting patients to take part in the study (this involves going through the information sheet and consent form and taking signatures from patients who would like to be involved)

  • Taking samples or measurements from patients

  • Issuing surveys, questionnaires or tests

  • Allowing a member of the research team access to the practice for the purposes of conducting research activity

  • Allowing a member of the research team access to your patient record system for the purposes of conducting research activity

In the new HRA system, when a practice takes part in a study their lead GP will normally take on the role of Principal Investigator (PI). This means they take responsibility for the conduct of the research at that site.

Working with others to contribute to a study

You can contribute to studies in other ways than your practice recruiting patients or running the study. You can feed into where you think researchers should focus their research, or become part of a team feeding into a research proposal.

If you are interested in being part of or feeding into a research application, please contact the WY R&D Team to let us know what areas you are interested in and we may be able to match you up with studies in the area.

Or why not become a reviewer to inform the development of new NIHR studies?

What to Consider Before Taking Part
What you need to know when getting involved
  • What studies are taking place in my area?

  • How will I be recompensed for taking part in a study?

  • Who should I contact in case of any questions?

You can read more about opportunities for GPs in research here.

Before a researcher comes to your practice they should have the correct approvals in place (what is required?) which means the study has had the proper checks, insurance is in place, and the research team have been checked to make sure they are appropriately qualified to undertake the research activity. Researchers accessing your practice should present a Letter of Access which confirms they have gone through pre-employment checks and have necessary training to carry out the research tasks. If you are not sure please contact us for advice.

A central check is conducted by the Health Research Authority (HRA), and once the HRA issues an approval letter, sites can agree to participate. HRA approval combines ethical approval, checks for consistency and completeness of documentation, feasibility and practicability, any special approvals e.g. for studies involving human tissue, radiation etc. If there are any excess treatment costs or savings these are also signed off by the CCGs. General practices 'sign off' as independent contractors to state that they have the capacity and capability to participate. At West Yorkshire R&D we can provide advice to practices regarding this, so please do not hesitate to get in touch.

What the practices are then signing for is to agree whether they have capacity and capability to undertake the study. This is done through a Statement of Activities and Schedule of Events – documents which should be filled in by the study team (one for each type of site which will be part of the study). For commercial studies it is the Industry Costing Template which performs this function. These detail what exactly will happen at the site and when, and what the costs are. The practice should review this, can negotiate the detail with the study team and respond by email to confirm their willingness to participate. In some cases, an HRA approval letter will confirm that formal confirmation of capacity and capability is not required. If a study team wants to come to your practice to carry out a study they will send you all the approval documents along with further information to introduce the study. You should either receive an HRA Initial Assessment Letter or HRA Approval Letter which will give you further information and will confirm whether HRA Approval has been granted (yet). Before you can start the study you must see the HRA Approval Letter. 

The West Yorkshire R&D Team is available to support you in reviewing studies and helping you to make sure you have taken all relevant factors into consideration.

As a starting point, you will probably want to think about:

  • Does the study interest us and have a benefit for our patient population?

  • Has the study been appropriately financed? i.e. will our time and facilities be financially covered?

  • What resources does the study require and do we have these available: e.g. Staff, skills, facilities?

  • How much time will the study take? For which staff members? Can we spare the capacity? Are the appropriate staff willing to be involved?

  • What arrangements would need to be put in place for the study to take place?

  • How many patients does the study team wish to recruit? Do we have sufficient patient population? Does our patient population have the demographics/conditions the study team is looking for?

  • Is there any special equipment required for the study? Do we have the required equipment?

  • Does the study require access to the clinical system – are they set up to use the clinical system that we use (some studies may only be able to work with SystmOne data, or EMIS data)?

  • If the study team is asking to access our facilities/patients/systems, do we accept this? Please note that they will need a Letter of Access issued by the CCG to access practices – this should be shown to the practice before they can access your site, and demonstrates that they have had pre-employment checks, DBS checks where appropriate and are suitably qualified.

  • Has the study team sufficiently considered how our patients’ data and/or samples will be handled and transported? Does this comply with our data protection requirements?

  • If there is a study treatment involved, does this cost more than standard treatment? If so, has the CCG agreed to pay for the excess? The study team should have a letter from your CCG stating that they agree to cover this cost. 

  • Have there been any amendments to the study? Practices should make sure they review these as they can mean significant changes to what was originally proposed in the study documentation.

How will I be recompensed for taking part in a study?

The financial element of a research application is part of the HRA Approval. This will ensure that all aspects of the study are funded properly, either through the research funding or through money available from the Local Clinical Research Network (LCRN) to fund study support costs (portfolio studies only). If there is a treatment involved in the study which costs more than the standard treatment, the CCG has to provide a letter if they agree to fund it.

In addition, if there is a total of more than 500 patients recruited to studies across a particular CCG in any given year, this then triggers a payment to the CCG which is invested research in the following year.

Who should I contact in case of any questions?
  • If you have questions about the study, your contact should be the sponsor.

  • If you have questions about the process or would like any advice, you can contact the WY R&D Team.

  • Find out what you need to know about the research governance process?

 

If you have been approached and are not sure whether you want to be involved in a study, or whether it has been through the appropriate checks, please see our guide below, or contact us for advice.

To find out about the study and exactly what activity the team would like to carry out, reading the protocol should give the essential information. This should tell you what exactly will be asked of you and your patients, so you can decide if you want to be involved. This is entirely voluntary. It could be as little as performing a database search or could be actually conducting research at your site.

Before a study can go ahead at a practice, there are a number of things you will need to see as a practice to make sure the researchers have gone through the proper checks. We have put together an outline checklist which may help you to know what documents you need to see.

As a starting point, you will probably want to think about:

  • Does the study interest us and have a benefit for our patient population?

  • Has the study been appropriately financed? i.e. will our time and facilities be financially covered?

  • What resources does the study require and do we have these available: e.g. Staff, skills, facilities?

  • How much time will the study take? For which staff members? Can we spare the capacity? Are the appropriate staff willing to be involved?

  • What arrangements would need to be put in place for the study to take place?

  • How many patients does the study team wish to recruit? Do we have sufficient patient population? Does our patient population have the demographics/conditions the study team is looking for?

  • Is there any special equipment required for the study? Do we have the required equipment?

  • Does the study require access to the clinical system – are they set up to use the clinical system that we use (some studies may only be able to work with SystmOne data, or EMIS data)?

  • If the study team is asking to access our facilities/patients/systems, do we accept this? Please note that they will need a Letter of Access issued by the CCG to access practices – this should be shown to the practice before they can access your site, and demonstrates that they have had pre-employment checks, DBS checks where appropriate and are suitably qualified.

  • Has the study team sufficiently considered how our patients’ data and/or samples will be handled and transported? Does this comply with our data protection requirements?

  • If there is a study treatment involved, does this cost more than standard treatment? If so, has the CCG agreed to pay for the excess? The study team should have a letter from your CCG stating that they agree to cover this cost.

  • Have there been any amendments to the study? Practices should make sure they review these as they can mean significant changes to what was originally proposed in the study documentation.

You may be asked to sign a contract, which will usually be a standard format (the Department of Health advises that researchers use their standard template). Alternatively, the study team may want to use a Statement of Activities in place of a contract. If you are asked to sign any other contract you may wish to ask for legal advice.

Maybe this has piqued your interest, but you have decided that you don’t want to be involved with the particular study which approached you. To find out about other research in the area, click here, or to develop your own study idea click here.

What do I need to know about the research governance process?

What next?

After reviewing the content of the study and gaining an understanding of what your practice is being asked to do, there are a few things you need to check before a study can go ahead.

There are extensive checks carried out for all studies, to make sure they are ethical, feasible, well-planned, have consulted with the necessary groups including patient groups, and to make sure the staff involved are suitable. 

HRA (Health Research Authority) approval – the HRA issues a letter confirming that the study has been accepted from a governance point of view. Make sure that you see a copy of the approval letter, not just the initial assessment letter.

REC (research ethics committee) approval – the HRA letter will refer to the REC approval letter where applicable. This confirms that ethics checks have been carried out. Ethical approval is not needed for staff-only studies or for some other types of study. If you are not sure please contact us research@bradford.nhs.uk.

Statement of Activities and Schedule of Events – for non-commercial studies this explains what exactly will take place at your practice (if you agree), financial considerations and data arrangements. Practices must sign the Statement of Activities to agree that they have assessed and arranged their capability and capacity and are ready to proceed. For commercial studies an agreement will be in place which practices should sign to agree to take part.

Excess Treatment Cost agreement – if the study treatment costs more than standard NHS care, the difference is paid for by the CCG. This means the CCG has to agree to fund the cost and will issue a letter to the study team to confirm. If you are not sure whether an Excess Treatment Cost is involved please contact us research@bradford.nhs.uk

Advisory email regarding Capability and Capacity. The West Yorkshire R&D Team has an overview of research taking place in primary care and will review all studies and retain a copy of the document set. We will be able to advise your practice on whether there are any issues regarding capability and capacity, any overlaps with other studies, any over-use of a particular patient population. The study team should share this email with participating practices.

Letter of Access – if anyone is coming into your practice who is not a member of your practice staff, even if they are an NHS employee, they will need to show you a Letter of Access. This is issued by the West Yorkshire R&D Team to confirm that the person is suitably trained and checked to carry out the planned research.

When you have seen these documents, your practice must decide whether to take part. Once you have considered the implications of carrying out the study, if you have any questions please do not hesitate to contact us for advice research@bradford.nhs.uk. If you are happy to proceed you need to sign the Statement of Activities.

Study teams will usually hold a Site Initiation Visit to ‘kick off’ the study at your practice. Practice staff should attend if they are conducting any elements of the research.

You should receive a site file which should be held at your site and updated any time there is a change to the study.

The Principal Investigator is responsible for all research activity taking place at the site. If someone else is to carry out a particular duty, for example a healthcare assistant may take blood samples, this should be documented to say that the Principal Investigator delegates that duty to the healthcare assistant. A full delegation log listing out all delegated duties should be held in the site file and signed by the Principal Investigator and delegates.
CVs for any staff undertaking research at the site should also be held in the site file.

Copies of all the latest versions of study documents – e.g. consent forms, patient information sheets, protocol, should also be kept in the site file.
Consent forms should be held securely but separately from the site file.

At the Site Initiation Visit, you should be given a process for reporting adverse events or issues, and a contact in the research team for any queries.

After the study

Your practice should retain the site file and consent forms after the study for an agreed period of time (agreed with the research team).

 

For health professionals research has a really important role in supporting evidence-based decision making and treatments. We are gathering information on our website that has arisen from research studies which have taken place in our area. This is a developing resource which will grow over time. We also provide links to accessing published evidence and research findings, many of which you may have access to through your NHS organisation or academic institution.

How we can help

Closed Trials

Information about trials closed to recruitment, including findings of research studies, will be shared on our website under Trials Closed to Recruitment.

Repository

You can access our repository here. Through our repository you can also access information about how to find and understand evidence reports.

Newsletters

We feed into various newsletters, including those received directly by commissioners and health professionals. Please contact us if you would like to contribute information to these newsletters to raise awareness about research related activity.

We also produce our own twice yearly newsletters aimed at anyone with an interest in NHS research:

If you would like to contribute to these please contact the team. If you would like to receive these then please join our mailing list.

Events

You can find information about events here, including events where research findings are shared and discussed.

We hold twice yearly themed evidence events, where research findings are shared directly with commissioners and clinicians. You can read about our most recent events below:

If you would like to be informed about future events please contact us.

Our next event will take place in October 2018 with the theme of earlier diagnosis of cancer. Contact us to register.

Practice Protected Time

We regularly hold stands at commissioner-led practice protected time events. We use these events as opportunities to engage directly with primary care professionals in our area, sharing information about the work we do and local research activity.

If you see our team at one of these events then please do feel free to approach us with any questions you have about NHS research or to share and discuss your own experiences of taking part in research in the area. Your feedback will help us to ensure that we respond to your needs, providing information that you will find valuable and pertinent. We also hope to help to address any barriers that may be preventing you from becoming engaged with research.

Research Network Meetings

Research Network Meetings are open to attendance by practice managers, general practitioners and any general practice staff members with an interest in research. These sessions include presentations given by researchers about studies taking place across locally. 

These meetings begin with a meet and greet session where research professionals can network over a buffet lunch. This is followed by presentations by academics sharing information about upcoming projects, studies open for recruitment, or research study findings. We aim to provide an opportunity for the discussion of potential research ideas in their early stages, so as to enable the troubleshooting of issues that may arise in relation to the practicalities of delivering a research project in a primary care setting; this feedback can then be taken into account during the initial stages of a project's development. These meetings are also a chance for study teams to thank those who have taken part in a study whilst sharing study findings, and for primary care staff members to ask any questions they have about research in the area.

Our colleagues from the Clinical Research Network: Yorkshire & Humber Division 5 are often present at these meetings, providing further opportunities for collaboration between the National Institute for Health Research, commissioners, research academics and healthcare professionals. There is always time set aside for any questions or discussion around the topics presented, where we share our experiences of research in primary care and learn from each other.

To register interest in attending future network meetings please contact our Research Engagement Officer.

News

Dr Stephen Bradley, Dr Neil Lawrence and Paul Carder (our Head of Research) ...


The latest update on national changes to the Excess Treatment Cost process can ...