The Health Research Authority (HRA) is one of a number of organisations that work together in the UK to regulate different aspects of health and social care research. We protect and promote the interests of patients and the public when they, their tissue or their data, are involved in research in the NHS. We also run the Research Ethics Service, providing the ethics review of health and social care research.
But how do you know if your project counts as research?
Dr Simon Kolstoe is a Research Ethics Committee Chair who also chairs the Ministry of Defence Research Ethics Committee and the UK Health Security Agency Research Ethics and Governance Group. With lots of experience of helping researchers work this out, he has published a paper with Janet Messer, Director of Approvals at the HRA and others, which is designed to help researchers and others involved in project governance to understand when an NHS research ethics review is needed.
Janet Messer, Director of Approvals, said: “This is a topic that can often puzzle researchers and care teams. It’s important because it influences the permissions needed to run projects, and so also affects project timelines. The question isn’t always straight forward. A lot of activities that people do as part of their daily jobs look a bit like research, but their ethics and governance issues should be dealt with elsewhere.”
At present, there are two online tools called Is my study Research and Do I need a REC review? to help researchers and care teams make this decision, which are reviewed in the paper.
The online tools are based on a decision table that summarises both UK legislation and the guidance within the HRA’s Governance Arrangements for Research Ethics Committees (GAfREC).
Dr Simon Kolstoe, Research Ethics Committee chairThe HRA works with partners to update the decision table regularly, and the new paper describes the thinking that led to the most recent update of the decision table. It also covers the areas which people are struggling with when trying to decide if their project is research and the perspectives of the Research Ethics Committee when considering applications.
During the pandemic, we found that public health professionals were unsure whether surveillance activities count as research, because they involve collecting data from people and analysing it. We clarified that surveillance involves similar activities to research, but has a different purpose. That means we manage them in different ways.
We did not make any changes to policy when we updated the decision table. The paper explains how the revisions help to make clearer why some projects are considered research from the perspective of ethics committee review, and why others fall outside the net.
Janet Messer, Director of ApprovalsService evaluations are another and perhaps the best example of an activity that looks like research but isn’t. In fact, these are a normal aspect of healthcare service management, and so the accountability and responsibility for assessment of the proposed activity is held by health and care teams. It would not be a good use of everyone’s time if an NHS Research Ethics Committee had to review every service evaluation in the NHS.