Do I need ethical approval?

Let’s start with ethics. NHS Ethics sounds obvious right? Wrong. First of all. What is ‘NHS’? The lines between NHS, social care and contracted services are not always clear. I’ll also point out that when people say ‘NHS Ethics’ it’s not about local NHS Ethics within NHS Organisations, it’s NHS Ethics centrally operated by the Health Research Authority.

When using the ‘Do I Need NHS REC review?’ Tool which I thoroughly recommend using (see link below), the most pertinent question for this aspect is:

“Will your study involve research participants identified from, or because of their past or present use of services (adult and children’s healthcare within the NHS and adult social care), for which the UK health departments are responsible (including services provided under contract with the private or voluntary sectors), including participants recruited through these services as healthy controls?”

For most pharmacists, this will likely mean that your answer is therefore yes, where your research involves patients, recruited through any setting including community pharmacies.

NHS Ethics however, excludes audits and service evaluations. Therefore NHS Ethics is only required for studies which are classified as ‘research’. Not sure if your study is research or not? They have a tool for that too. Research is not defined necessarily by the methods which you employ, but the outcomes you intend to generate. The tool is really helpful (see below for link).

However, just because your study may not involve patients, does not mean that it does not need to undergo ethical approval. For instance, the University of Sunderland defines research requiring ethical approval as “any study which involves human participants, their tissue or their data’, including audits and service evaluations” (see link).

Equally in hospital trusts, you may have an internal ethics committee that evaluates research that falls short of the definitions set out in the NHS Ethics principles of the Health Research Authority.

The purpose of ethical approval is quite simple but very important – to determine what the implications are for participating in a research study from the perspective of the participant. What are the risks? What are the potential benefits? Will the researcher be able to protect the rights of participants who are involved in their research?

If researchers haven’t sought patient and public involvement in the design of their research, this may be the first time that they consider some of these perspectives and certainly when I went through the NHS Ethics process, the fact that I had involved patients in the design made answering some of the committee’s questions much easier (more on NHS coming soon).


Do I Need NHS REC review?

Is my study research?

University of Sunderland Ethics and Governance (example of HEI procedures):

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