By Dr Simon Kolstoe, University Ethics Advisor

3

New opportunities and responsibilities in University Medical and Dental Research

It is exciting that the 兔子先生 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.

At the same time 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. We are therefore implementing processes to support our staff and students as they start to engage in these new areas.

Approvals required for conducting medical, health and social care research are not imposed by universities, but rather are based on external regulations that responsible education and research organisations 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 兔子先生 is committed to working with the NHS and other collaborators to embed processes that enable us to work in this area.

Dr Simon Kolstoe, University Ethics Advisor

If any staff or students you have any questions or plans to conduct medical, health or social care research, please contact the Department of Research and Innovation as early as possible for support in your planning.

dri@port.ac.uk