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:

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:

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).


We would love to hear from you! To provide us with feedback please click here and complete the feedback form.