Recruitment of participants

There are many options for recruitment of patients and these will depend on your particular study. This will have been thought about this at the design stage and incorporated into your research proposal and grant funding application. You should also have designed your recruitment materials prior to obtaining REC approval and NHS Permission as these materials will need to have been submitted for review as part of the approvals process.

Some of the common methods used in primary care to recruit participants are detailed below.

Database Searches and Mailshots

This is commonly used in primary care. As a researcher you need to be clear what you can and cannot do in terms of recruitment of patients – this is detailed in the attached guidance note on access to patient notes.

Key factors to consider when using this method of recruitment:

• Can you easily search for patients that fit your inclusion / exclusion criteria? Are there specific READ codes you can use?
• The list of potential participants resulting from your search must always be checked by a clinician before any mailings are sent to exclude inappropriate patients
• You must provide patient information packs, reply slips, envelopes and postage – bear in mind that the response rate will depend on the study and may only be 1 in 10
• Do you need any reminders to be sent? How will you track replies so that you exclude these from any reminder mailings?

Opportunistic Recruitment

This can work in some cases, however you need to bear in mind that your research project will not be forefront of the mind of the clinical team identifying your patients for you. Key factors to consider are:

• What tools can you use to flag this up to clinicians when they see potential patients? For example tagging of notes, use of recruitment materials (posters / flyers) to allow patients to self refer.
• You should aim to get all members of a clinical team to buy into the study to maximise recruitment.

Informed Consent

All participants taking part in any research proposal must give full informed consent.

For consent to be ethical and valid in law, participants must be capable of giving consent for themselves. A capable person will:

• Understand the purpose and nature of the research.
• Understand what the research involves, its benefits (or lack of benefits), risks and burdens.
• Understand the alternatives to taking part.
• Be able to retain the information long enough to make an effective decision.
• Be able to make a free choice.
• Be capable of making this particular decision at the time it needs to be made (though their capacity may fluctuate, and they may be capable of making some decisions but not others depending on their complexity).
• There are specific requirements when the research intends to make audio and visual recordings of patients. The GMC has produced a guidance document about this which details the issues related to research in paragraphs 22-35.

A participant information sheet should be supplied for participants which gives details of the study, and participants should be given adequate time to decide whether to take part (usually >24 hours).

For interventional studies it is usual for consent to be given within a face to face discussion with the researcher / GP / Nurse after a full explanation of the study. The person taking consent should be appropriately trained / experienced / qualified to do so.

Postal consent may be appropriate in certain circumstances – for example where the research activities are limited to collection of data from the notes, and in some instances implied consent may be appropriate – for example one-off postal questionnaire based studies where consent is implied by return of the questionnaire – however it this must be made clear to the participant in the information supplied.

The Research Ethics Committee when reviewing your study will take particular interest in how you are planning on obtaining consent and the information supplied to participants. You should have supplied copies of all your consent material (invitation letters, information sheets, consent forms etc) as part of the process of gaining ethical approval and NHS permission. Any changes to these materials or any new materials needs to be reviewed by these bodies PRIOR to use.

NHS Norfolk in collaboration with the PCRN East of England have produced a DVD which illustrates good practice in informed consent – this is available on request from the R&D Office at NHS Norfolk.

External Links

• RCN Informed consent in Health & Social Care Research
• GMC – Consent to Research

Monitoring Recruitment

You need to provide the R&D office at NHS Norfolk details of all participants recruited to your study within NHS Norfolk sites or PICs on an ongoing basis. This is required for several reasons:

• For payment of support funding to practices and services as this is paid on the basis of activities undertaken.
• For DH reporting requirements through the National Quality Accounts
• To identify and troubleshoot poorly recruiting studies

Ongoing Communication with Recruiting Sites

You should ensure that you communicate regularly with all recruiting sites with study progress and changes. This will help to keep them motivated and ensure your study is high on their agenda. This will also enable you to pinpoint and solve any problems they might be having with your study early on.