The definition of research in health care is constantly evolving and has been defined differently by a number of organisations. For the purpose of research governance in the NHS, research means the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.  This definition includes studies that aim to generate hypotheses as well as studies that aim to test them. Research is to find out what you should be doing; audit and evaluation are to find out if you are doing planned activity and whether it is working.

To help you decide whether a project should be classified as research, you should refer to this document (Defining Research).  For additional and more detailed guidance please contact your directorate research representative or Helen Allbutt (0131 656 3245)

There are several stages to the approval process for research activity.

NES approval

In the first instance, you should seek and receive approval from a NES Director or their nominated representative before you proceed with your research.  Each directorate has a research representative who should be your first point of contact:

• Dentistry - Linda Young / Claire Tochel
• NMAHP - Iain Colthart, Lesley Whyte, Val Blair
• Medicine - Peter Johnston
• Pharmacy - Ailsa Power
• Planning – Helen Allbutt
• Psychology - Neil Millar

If you are proposing to undertake research and are located in another directorate, please contact the relevant Director for approval.

Ethical and Management approval

If you wish to conduct research in NHS or community care settings, you must also obtain NHS management permission (also referred to as local R&D approval) from each site/board area where your research is being carried out.

You may also need to apply for and receive approval from an established NHS Research Ethics Committee (NHS REC Review). You will likely be required to do so if your research is proposing to investigate:

• service users and/or carers (past and present)
• adults (age 16 or over) who lack capacity to consent for themselves (applications must go to Scotland A Research Ethics Committee)
• prisoners
• practising midwives conducting a clinical trial
• confidential patient information

If this is the case, you will have to make your application using the Integrated Research Application System (IRAS).

There is no longer a requirement to apply for NHS REC review if a project involves NHS staff recruited as research participants by virtue of their professional role.  Similarly, research that makes use of, or requires access to, NHS premises or facilities does not need REC review.

If you are undertaking research as part of a higher degree, you will also need to check whether under your institution’s policy and internal arrangements, ethical review is required.

Please also refer to the NES Research Governance Policy for further details.

Your directorate should have approved the project monitoring arrangements in place for your study.  All research projects should be registered on the NES Research Register and progress should be updated at least on a quarterly basis (NES Research Register).  Your directorate research representative has access to the register and you should liaise with him/her in a timely manner.  

If your project is likely to be more than one year in duration, then you will be expected to provide an interim report mid-way between the start and end of your study. Final research reports should be received within an appropriate timescale (usually 6 months) following completion of your study.

Your directorate research representative is your first point of contact:

• Dentistry - Linda Young / Claire Tochel
• NMAHP - Iain Colthart, Lesley Whyte, Val Blair
• Medicine - Peter Johnston
• Pharmacy - Ailsa Power
• Planning – Helen Allbutt
• Psychology - Neil Millar

Helen Allbutt (0131 656 3245) may also be contacted for advice.