A plain-English guide to the UK regulatory framework for clinical research in general practice.
Clinical research in the UK operates within a three-layer regulatory framework. Understanding which layers apply to your study determines what approvals you need and how long setup will take. The good news: not all layers apply to all studies, and primary care has access to faster routes than most hospital-based researchers realise.
The MHRA regulates clinical trials involving investigational medicinal products (CTIMPs) — that is, trials testing drugs or biologicals that do not yet have a marketing authorisation, or that are being tested outside their licensed indication.
If your study involves a CTIMP, you need a Clinical Trial Authorisation (CTA) from the MHRA before you can start. CTAs are applied for by the sponsor (usually the pharmaceutical company), not the site. As a GP site, your responsibility is to ensure you have a valid CTA in place before enrolling any patients.
If your study does not involve an investigational medicinal product — for example, a device study, an observational study, or a service evaluation — you do not need MHRA authorisation.
The HRA oversees research governance and ethics for health and social care research in England. HRA approval is required for all research studies (but not service evaluations). It provides a single approval that covers NHS R&D permissions across all participating sites in England.
The HRA decision tool (available at hra-decisiontools.org.uk) helps you determine whether your project constitutes research (requiring HRA approval) or a service evaluation (which does not). This distinction is critical for primary care, where many commercially-sponsored activities are structured as service evaluations to enable rapid setup.
A Research Ethics Committee reviews research proposals to protect the rights, safety and wellbeing of research participants. REC review is required for most research studies and is coordinated through the HRA approval process.
Importantly, REC approval is not required for service evaluations or quality improvement studies. This is why sponsors and practices increasingly favour the service evaluation route where it is scientifically and ethically appropriate — it can reduce setup time from months to weeks.
The HRA decision tool takes you through a structured set of questions to determine the nature of your project. Key factors include: whether the project involves randomisation, whether patients are exposed to interventions not part of their normal care, and whether the primary purpose is to generate generalisable knowledge.
If the tool concludes your project is a service evaluation, you can proceed without HRA or REC approval — subject to Caldicott Guardian sign-off and local governance requirements.
Good Clinical Practice (GCP) is the international quality standard for designing, conducting, recording and reporting clinical trials. Compliance with GCP provides assurance to regulators and sponsors that the data generated is credible and that patient rights are protected.
For GP practices, GCP compliance means: completing GCP training (free via NIHR Learn), maintaining accurate trial master files, obtaining valid informed consent, reporting adverse events according to protocol, and ensuring your site is inspection-ready at all times.
PCRA has extensive experience navigating the UK regulatory framework. We support member practices through the full approval process, from HRA decision tool to site initiation visit.
Talk to PCRA →PCRA supports practices through every step of the research governance process.
Get in touch →