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.

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:

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?

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