Is My Work Considered Research?

Are we sure we know what research is?

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We are absolutely dominated by tech in our day-to-day lives, and whether we are aware of it or not, our data is being collected - and constantly. If you own a smartphone and have a network carrier for 3G, 4G or 5G, you'll likely be submitting swathes of data -personal or not- as you walk down the street. Your geolocation data, all sorts of metadata attached to your camera app and social media data from a variety of apps you will likely have installed on your device, too.

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Tech giants have become incredibly good at data harvesting as we live and breathe, but let's instead consider data collection in a different way to the sales, marketing and advertising campaings of these behemoths - as part of research. Any astute researcher will have a veritable battery of unanswered questions for their area of interest: What is the propensity for population "X" to develop a certain disease phenotype? How long will it take? What confounding factors might influence the results and outcomes? The list goes on.

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In the UK at least, a common colloquialism touted in data science is "Data is King". While that is probably unashamedly true, to obtain that data in the first instance comes with unavoidable ethical considerations and complications- especially in healthcare and digital healthcare.

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If you're interested in capturing data in healthcare, especially in the UK, you will likely want key insights into humans and human-like responses in some meaningful and measurable way. You might then find yourself wondering where your proposed work sits in this context. Thankfully, the Health Research Authority (HRA) have set out guidelines for you to be able to assess whether your work in the UK is deemed research or not. You can check this yourself on their decision-making tool which is in line with the UK Policy Framework for Health and Social Care Research. We've summarised what the tool covers, but always check for yourself here. The tool itself has been aligned to "Defining Research" - a document outlined by Research Ethics Service, which can be found here.

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What is Research?

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What defines research in the context of Research Ethics Services, the UK Policy Framework for Health and Social Care Research and the HRA can be covered with three important questions in the decision tool. We will address these here:

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1) Are the participants in your study randomised to different groups?

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Typically, in investigatory studies where different groups or people are used, randomisation occurs. This is where people are randomly allocated to receive (or not) some intervention. This does not have to be restricted to just one treatment and a placebo. Randomisation is a powerful tool in research and enables strong support for true effects in an intervention.

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If you are using participant randomisation, your work is considered research.

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2) Does your study protocol demand changing treatment/care/services from the accepted standards for any of the patients/service users involved?

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This question is underpinned by two key definitions which are covered more comprehensively here:

• Clinical Audit, which encompasses a quality improvement process seeking to improve patient care and outcomes through a comprehensive/systematic review.
• Service evaluation or Service Improvement / Development, which examines how the standard of care is delivered or measure improvements in standard card.

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If this point applies, your work is considered research.

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3) Is your study designed to produce generalisable or transferable findings?

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A key feature of research is that it is intentional and planned and that findings from such work can be applied to a larger population. The terms 'generalisable' and 'transferable' have very specific meanings in this context, but can broadly be explained by the study intention: Are you looking to deliberately achieve some general outcomes which can produce some qualitative or quantitative findings that can be transferred to a similar situation or study?

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If this sounds like it is relevant to your work, your work is considered research.

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It's important to be methodical and careful when engaging in any new data capture project. Unforeseen or sometimes unanticipated ethical considerations can be revealed during the course of the work - and you don't want these to appear when it's too late. Comprehensive study design and review are absolutely key and, always - in the UK at least - follow the HRA guidelines here.

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I'm doing research, what are the implications?

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If you are conducting research, you might need a number of approvals in place before you can address the human population with your study. We'll discuss this in an upcoming blog so please keep posted.