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Abstract

Background
To ensure quality, safety and regulatory compliance, research carried out within the United Kingdom’s National Health Service (NHS) must undergo ethics and governance review before commencing. The use of Electronic Health Records (EHRs) holds potential for advances in research but comes with additional regulatory and governance challenges. This paper aims to illustrate these challenges through a case study of a research project involving primary care services.

Methods
A case study of the processes involved in setting up an investigation of health service use for perinatal mental health in England and Scotland. Twenty-six women provided consent for the research team to assess their health service use through examination of their EHRs held by General Practitioners (GPs). Data for the case study were drawn from records of project milestone dates related to ethics and governance processes, communications with governance bodies, and records of participant and GP engagement.

Results
Significant challenges included inconsistent responses among the eight local Research and Development (R&D) offices involved and additional bureaucratic requests leading to delays. Median time taken for R&D approvals was 43 working days (range 16 to 67), with one region’s approval still pending at study end after 100 days, and two regions not requiring approval. GP practices were difficult to contact and establish research contracts with, resulting in only four participants’ EHRs being obtained within the study timeframe, which was insufficient to fulfil the project’s original aims.

Conclusions
Although participants consented to use of their medical data for this research, regulatory and bureaucratic barriers prevented effective data access. This case study illustrates the need to revise and streamline governance systems, improve consistency across local sites, and reduce barriers to GPs’ involvement in research to maximise the potential of EHRs for research purposes.

Publication Type:	Article
Additional Information:	Copyright: © 2026 Moran PM et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Publisher Keywords:	Ethics, Governance, Primary care research, General Practitioners, Electronic health records, NHS Research and Development
Subjects:	R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine T Technology > T Technology (General)
Departments:	School of Health & Medical Sciences School of Health & Medical Sciences > Department of Nursing & Midwifery
SWORD Depositor:	Symplectic Administrator

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