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 National Institute for Health and Care Research (NIHR) Clinical Research Network (CRN) 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.
The NIHR website also has a section dedicated to the development of research nurses and midwives: Nurses and Midwives | NIHR
RCGP has an initiative, working together with National Institute for Health and Care Research (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?
There are a number of ways you can get involved in research – each with different levels of involvement.
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 Participant Identification Centre (PIC) 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
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 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.
Governance for studies is completed by the Health Research Authority (HRA). The HRA approval combines ethical approval with a review to ensure studies are scientifically valid, properly costed and feasible. Additional reviews are also carried out for studies involving human tissue, drugs or radiation. Once this review is completed, the local CRN signs off any local finances; some support costs are funded through the CRN and excess treatment costs are agreed by the CRN (but funded by the ICB). West Yorkshire R&D produces an advisory email to highlight any particular issues/considerations. Individual practices then ‘sign off’ to confirm they have the capacity and capability to participate. West Yorkshire R&D can also advise practices if you have any queries or concerns.
What the practices are then signing for is to agree whether they have capacity and capability to undertake the study. This is done through an Organisation information document 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 and localised for each site). For commercial studies it is a contract which performs this function - the HRA recommends use of a model agreement. 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 Integrated Care Board (ICB) 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 CRN agreed to pay for the excess? The study team should have a letter from the local CRN 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 clinical research network (CRN) to fund study support costs (portfolio studies only). If there is a treatment involved in the study which costs more than standard treatment, then the study must apply to have the difference (Excess Treatment Cost) funded. West Yorkshire R&D can advise if you are not sure about any of the financial elements.
In addition, if a particular area’s practices recruit over 500 recruits in one financial year, this triggers extra funding which is reinvested into future research in the area.
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 ICB 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 local clinical research network (CRN) agreed to pay for the excess? The study team should have a letter from the CRN 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 National Institute for Health and Care Research advises that researchers use their standard template). Alternatively, the study team may want to use an organisation information document 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 you can email us, or read more about developing your own study idea.
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:
-
Health Research Authority/Health and Care Research Wales (HRA/HCRW) 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.
-
Research Ethics Committee (REC) 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.
-
Organisation information document 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 organisation information document 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. For studies where you are only being asked to put up a poster, there is no need for these documents, but you should ensure that the study is HRA approved before advertising the study.
-
Excess Treatment Cost (ETC) agreement – if the study treatment costs more than standard NHS care, the difference is paid for by the local clinical research network (CRN). This means the CRN 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 organisation information document or site agreement.
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 must be updated any time there is a change to the study. For an idea of what might be included in the site file please see suggested file contents on the NIHR website.
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 (including practice staff who are involved) 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
Repository
You can access our repository here. Through our repository you can also access information about how to find and understand evidence reports.
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 health care professionals. You can read about our most recent events below:
If you would like to be informed about future events please contact us.
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.
