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New opportunities but also risks in University Medical and Dental Research

Dr Simon Kolstoe, University Ethics Advisor

It is exciting that the University is now planning for its own Medical and Dental schools. Along with enhancing our reputation and contributing to the health workforce, this will also bring about exciting new research opportunities across all faculties.

However, medical, health and social care research brings with it specific responsibilities because it is one of the few areas of research that is regulated. It is sometimes surprising as to the type of research that falls under such regulation. For instance, any App that collects or processes health data, including mental health data, may fall under the Medical Devices Regulations regardless of whether the data is anonymous. Over recent years we have seen an increase in both staff and project students wanting to apply new technology to health questions, but it is vital that this is done within the law. What may sound like a simple idea for a student project could inadvertently stray into regulated research if supervisors and staff are not aware of their wider obligations.

Approvals required for conducting medical, health and social care research are not imposed by the University alone. Often these are required by external regulation that the university, as a responsible education and research organisation, must follow. For instance, many researchers will be aware of the Data Protection Act 2018, also known as UK GDPR, but if you want to use health data in research you also need to be aware of the Common Law Duty of Confidentiality (COPI) and related regulations. Similarly, any work with human samples needs to comply with the Human Tissue Act 2004 (even if it is only saliva samples or swabs), while understanding the research provisions of the Mental Capacity Act 2005 can be important especially for work in social care research that might involve people with dementia or others with a limited capacity to consent.

Perhaps the strictest laws governing research are the Clinical Trials Regulations 2004 (including the recent 2025 update) and the Medical Devices Regulations 2002 (including recent updates through secondary legislation). Research falling under these regulations often have risks for participants, so it should be no surprise that they are tightly regulated. The ÍÃ×ÓÏÈÉú does not have a strong track record in conducting this type of research, and therefore it is vital that staff or students collaborate with an NHS trust who have the suitable infrastructure, experience and critically insurance. We are keen to see more medical trials conducted by university staff and students, but this type of work is complex and needs suitable time, resources, and regulatory guidance. Staff and students cannot do this on their own.

Having great research ideas and being encouraged by the university to conduct impactful research is clearly part of who we want to be as a research community. Regulation can sometimes feel onerous and against the spirit of research, but we must remember that it is there for a reason. Although most researchers will not want to cause harm, there are a lot of pitfalls inherent to medical, health and social care research. It is important not only to do research, but to do good research that is reliable, makes a difference, and critically does not cause harm. Rather than being a source of resentment, regulatory processes should instead be seen as an opportunity to think carefully about research and in so doing draw on the experience of others. Regulation is not going to disappear, so if we must engage with it, it is important to do this in a positive and informed way.