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).