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.

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?