Ethics

Under the Research Ethics approval system, what is a research domain and how does it affect my application?

A research domain is the area of the UK in which nine research sites are located and the research is conducted. It is not relevant where the research participants are resident, or which Primary Care Trust is responsible for the participants' primary care. This includes domains where participant-related research procedures specified in the protocol - including recruitment and informed consent - are carried out. Referral of a patient (possibly from another domain) for assessment and possible recruitment is not part of the conduct of the trial. The following are not considered to be research sites:

• Primary Care Trusts responsible for participants primary care unless participating in the conduct of the study.
• Clinicians or clinical units making referrals to the research team
• Research units undertaking support functions, eg project management, site monitoring, data analysis, report writing.

A "domain" is defined as follows:

• In England, the area covered by a NHS Strategic Health Authority.
• In Wales, the area covered by one of the regional offices of the NHS Wales Department.
• In Scotland, the area covered by a NHS Health Board.
• The whole of Northern Ireland under the aegis of Health and Personal Social Services.

Where the Chief Investigator plans eventually to conduct a study at sites in two or more domains, it should be allocated by Central Allocation System for review as a multi-domain study, even where research sites have so far been identified in one domain only. In rare cases, a study may be taking place at a single research site spanning the boundaries of two domains.

If the study is a Clinical Trial of an Investigational Medicinal Product (CTIMP), it should be allocated by Central Allocation System.

Is there help available in writing patient information sheets?

Yes. The NRES website contains further guidance of what a patient information sheet should include.

Help is also available from the Research Design Service on 0117 342 0233.

I need to increase recruitment for my research project, can I advertise for participants?

Yes, however the NHS Research Ethics Committee undertaking the ethical review will need to approve the generic wording of any advertisements as well as the type of places they will be placed (eg local press/national press/GP surgeries). Locality assessors will need to sign off any locality issues, such as where the adverts will be placed specifically and any contacts given on the advert.