Do I Need Ethical Approval for my Study?

How do I know if my work requires Ethical Approval in the UK?

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We all want to ensure participant protection and reduce risks of harm - so much so that numerous regulatory frameworks and highly evolved guidelines are in place today to uphold trial quality standards. But, as we know, not all studies are the same and the ethical requirements or expectations for your study might vary. In addition, if you are not conducting "research" in the traditional sense you might not even need ethical approvals per se.

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So when you're deciding what your next project will be, how can you be sure what you need to do? We've seen a boom in open label and post-marketing research in recent years, and with increasingly accessible tools such as real-world evidence/data collection, the justification to take a 'non-RCT' route, particularly in food sciences, can actually be very sufficient to achieve some of your research and marketing objectives.

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This article focuses on points from the Health Research Authority (HRA) decision-making tools. While guidance is provided here, always consult the links below for more information:

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Is my work research? << Decision-making tool ‍

Does my work need NHS ethical approval? << Decision-making tool

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So how will you know if your study or trial requires ethical review and approval by an NHS Research Ethics Committee (REC)? Here's our quick guide on what you need to know for ethical approval of UK trials:

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Useful points to consider and ask yourself in advance:

• Is my product already at market and is the proposed work post-marketing surveillance?
• Does it already have some clinically validated evidence from, e.g. RCT? Does my work need to be an RCT?
• Does my product already have claims, certifications or safety status/es? E.g. EFSA? GRAS? - is that what I'm looking to achieve?
• Will my study include a placebo group and allocation of groups or study arms?
• Is my product a food or supplement?
• What is the population or cohort I intend to work with?
• Is it NHS ethics I need to apply for or can local independent school/academic ethics be sufficient?

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Step 1: Is your study considered "Research"?

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This point might seem plainly obvious but is often overlooked, particularly in a commercial setting. Gathering marketing information for products already available might seem like research. One might assume that, since valuable data is being collected and analysed, this would require formal ethical review. However, general data collection for the purposes of marketing doesn't necessarily constitute research - and your proposed study might come under this umbrella. Key deciding factors in this step include the allocation of study arms or groups, producing transferable findings, and the potential impact your work might have on current patient care. Further questions? Consult the HRA tool here.

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Step 2: First indications that you might need REC approval‍

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You will have indicated by this point that your work is considered research and that there might be some potential risks to participants. So what are the next steps? The HRA NHS REC review tool will help you determine whether you need review. Key questions you will need to address in this section surround the nature of your product and study - is your proposed work involving a Clinical Trial of an Investigational Medicinal Product (CTIMP)? Does it involve a CE-marked or non-CE-marked medical device? Does it involve ionising radiation and the Register of the Human Fertilisation and Embryology Authority (HEFA)?

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The outputs of these questions might immediately indicate to you that you need ethical approval, or you might need to go into more specific detail in-line with the location/country of your research.

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Step 3: Where is your study being carried out?

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Requirements for ethical review will vary between each region of the UK. Since each country will have its own health and social care framework and policies, some requirements will vary between location. Having said that, there are some standard items which are relevant across the whole of the UK. A key point in this section:

• Will your study involve potential research participants identified in the context of, or in connection with, their past or present use of services, including participants recruited through these services as healthy controls?

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The requirements for NHS ethical approval are weighted differently on each country and are too detailed to outline here, however, visit the decision-making tools here to find what you need for your country.

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Brief summary?

• All research is different
• Not all research needs NHS REC approval
• Simpler types of consent may suffice
• If you're conducting healthy volunteer work, without treatment groups or a placebo and your product is already on shelves, you might not need REC at all

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Are you looking to run a study in the UK in the near future? Will it be research or not? If you need any guidance or support, please do get in touch.