What to Consider When Taking Part in Research

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?