What you need to know when getting involved

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 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 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:

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?

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