Information for NHS staff, GPs and other independent contractors

As an NHS employee or independent contractor you may come across research in a number of ways:

• An external researcher may be working in your clinical area
• You may be asked to help identify patients / clients who would be potentially suitable for a particular research project.
• You may be asked to approach potential research subjects about being involved in a particular research project.
• You may be involved in conducting a piece of research, whether your own piece of research, or that of a colleague
• You may be asked to be a participant in a research project.

In all cases there may be a number of questions you may have. This section of the website aims to answer some of them.

Have you been approached to conduct a piece of external research?

Many patients and clients want to take part in research and should have the opportunity to do so.

If you are approached to help recruit patients or service users to a research project you should be clear about:

• What will be involved, including the time commitment for you or your staff. Please ask the researchers for any training or further guidance you or your staff need. If the study has been adopted by the PCRN then a summary form called a RISP sheet will be sent to your practice/service which will outline the detail
• Whether the project has all approvals in place. Although participants can be identified/flagged for potential participation in a research project they must not be approached about participation until Trust R&D approval (co-ordinated via the NHS Norfolk R&D office) is in place and a favourable opinion has been obtained from an NHS Research Ethics Committee.
  If in doubt, please contact the NHS Norfolk R&D office who will have information on all approved research projects taking place in primary care in Norfolk and Suffolk.
• Any confidentiality or data protection issues. Who has agreed to the practice / service involvement in the project.

Any researchers who are not Trust employees and who will have access to NHS patients, service users or patient identifiable data will usually be issued with an honorary contract or letter of access with relevant NHS organisation to cover them for the duration of their project within the NHS organisation. This ensures that the researcher abides by the Trust policies and procedures, particularly with respect to Health and Safety and Incident reporting procedures.

For further information on honorary contracts and letters of access for researchers, please go to the honorary contract page.

Research Conduct

Each study protocol should set out how the study procedures should be conducted. The study protocol should be accompanied by standard operating procedures and work instructions so that staff working on the study are clear about how the research team want the activities conducted and aims for uniformity across sites.

The Primary Care Research Network (PCRN) has produced a number of generic standard operating procedures for primary care NHS staff which details how research should be conducted. Please click here to access these PCRN operating procedures.

These operating procedures are generic in nature. The study related standard operating procedure will take precedence over the PCRN standard operating procedures where they exist. There will also be guidance documents on this site.

Below is some basic guidance on how to identify and approach patients or clients about a research project:

• The initial identification and approach to participants for research must be made a member of the care team. Researchers cannot be given patient contact details for research purposes without explicit patient consent.
• Care must be taken to ensure that any participants identified as potentially eligible for a research project are appropriate to approach, particularly if they are being approached by letter.
• All potential participants must be given adequate time to decide whether or not they wish to participate and should be provided with all the information necessary to make that decision. An information sheet will usually be provided by the researcher for participants which gives more details about the study. Potential participants should be free to ask any questions necessary to enable them to decide whether or not to participate.
• It should be made very clear to participants that participation or non-participation in any research project will have no bearing in any way on the care or treatment they are receiving or will receive in the future.
• It should be made clear to participants that they are free to withdraw from the project at any time without affecting the care that they receive.

Please click here for a downloadable version of this guidance.

Conducting your own piece of research

If you are wanting to carry out your own piece of research there are a number of groups locally who will be able to help you get your project off the ground - please click here for further details

NHS Staff as research participants

If you are an NHS employee or an independent contractor working with NHS patients or Clients (e.g. a GP, practice nurse, dentist, pharmacist) you may be approached to take part in a piece of research by virtue of your role as an NHS employee or independent contractor. This could range from a simple questionnaire based study, through to a study involving staff interviews, focus groups or observation of practice. The following page gives you more information about what issues you might want to think about before taking part

Incidents and Complaints

Many research projects have their own reporting requirements for incidents or complaints, however if you or a patient wish to complain about a piece of research taking place within your clinical area the normal Trust complaints mechanism will apply. Similarly any clinical incidents which arise from a piece of research should be reported in line with Trust incident reporting procedures. This is in addition to research specific reporting requirements.