Undertaking an extended role in research delivery

Clinical research in general practice is diverse, stimulating, and essential to the advancement of primary care. It encompasses a wide range of study types, varying in complexity and scope:

• Surveys are typically simple studies, using posters, practice websites, or text messaging to invite participation.
• PIC  studies involve searching electronic health records to identify eligible participants, who are then contacted by the practice to offer the opportunity to take part.
• Observational studies follow patient cohorts with specific health conditions over extended periods, collecting data on outcomes to understand disease progression or management better.
• Interventional studies are more complex, testing new approaches such as diagnostic tools (including digital tools), imaging techniques, medical devices, or medicinal treatments.

Studies may be sponsored by non-commercial organisations, such as academic institutions or charities where academic GPs and research teams are based, or by commercial partners from the life sciences industry, who often focus on interventional studies.

A GPwER in research delivery plays a pivotal role in ensuring these studies are conducted safely, ethically, and effectively. They lead the practice research team, oversee participant recruitment, and manage the delivery of each study, retaining overall accountability even when delegating specific tasks. Crucially, GPwERs must uphold research governance and ethical principles, ensuring that research is transparent, inclusive, and conducted in a manner that protects patient safety and maintains public trust. They need to guard against conflicts of interest that could compromise care or research quality, ensure patients have a genuine choice to participate, and contribute to studies that offer real benefits to both individuals and the healthcare system as a whole.

By embedding these principles into day-to-day research activity, GPwERs can help maintain high standards of practice, promote sustainability in primary care research, and foster a culture of accountability and integrity. Their work can ensure that research is feasible within general practice, relevant to routine clinical care, and delivered in a manner that strengthens the relationship between patients, practices, and the wider research community. Through these responsibilities, GPwERs act as a critical bridge offering research participation during routine clinical care, supporting both scientific advancement and ethical excellence in primary care research.

The delivery of clinical research studies is guided by the specific eligibility criteria of each study, typically determined by the health condition under investigation. Study designs vary, ranging from observational to interventional, and planned to opportunistic approaches. The target patient population can encompass the whole spectrum or patient population and health conditions from children with viral illnesses to older adults with chronic conditions such as kidney disease.

In principle, and depending on the study, all patients could be offered the opportunity to take part in research. Importantly, considerations of research equity and inclusivity should underpin study design and delivery, ensuring that patient recruitment is fair, representative, and reflective of the diverse populations served by general practice.

Primary care research delivery can occur across a range of settings, reflecting the flexibility and reach of general practice. Studies may be conducted remotely, allowing patients to participate from home, within the GP practice using the familiar clinical environment, in a local community, primary care network, or by identifying and referring participants for research conducted in secondary care or other specialised settings. This versatility enables GPs to support diverse study designs and patient populations, ensuring that research is accessible, inclusive, and effectively integrated into routine care without compromising patient safety or the quality of care delivery. Clinical research delivery is a practice level activity. The GPwER has a lead role ensuring the appropriate engagement of the wider practice team in the research activities.

The GP plays a central role in overseeing all clinical studies conducted at their practice. Some studies follow complex delivery pathways that require close collaboration with other professionals. For example, vaccine trials often necessitate laboratory support (such as microbiology or haematology) or imaging services, fostering coordinated working with secondary care colleagues. In Patient Identification Studies, the practice is responsible for identifying eligible participants and referring them to the appropriate study team, which may be based in another setting, such as a hospital. The identification can be done through detailed health informatics searches of the GP electronic health record to find those potentially eligible or by opportunistic recruitment triggered by electronic prompt.  Through these responsibilities, the GP ensures that studies are conducted efficiently, safely, and in alignment with research protocols, while facilitating seamless integration between primary and secondary care.

Clinical research in general practice is conducted under strict governance and regulatory frameworks to ensure safety, integrity, and scientific rigour. The GPwER in research delivery must maintain thorough knowledge of all aspects of the studies they oversee, including adherence to the study protocol and any amendments, timely safety reporting, accurate data collection, meticulous documentation, and knowledge of regulations that guide research. Competence in this role is evidenced through certification in GCP, which can be included as part of the GP’s professional appraisal.

All GPs should declare this role to their indemnity provider and be included in their appraisal framework.  Additional professional indemnity is not required for NIHR portfolio-adopted studies in England as they are covered under the CNSGP. In other regions, the GPwER should seek confirmation from their own provider.  All studies should carry their own individual study insurance.

Each study is supported by a dedicated research team, including a study monitor who reviews study delivery processes to ensure compliance with governance standards, accountability, and high-quality data collection.  Studies may also be externally audited and reviewed by the MHRA.   This oversight underpins research integrity and promotes continuous quality improvement. Studies may need risk assessment by the GPwER before initiation and comprehensive list of Standard Operating Procedures (SOP).

A GPwER in Research Delivery is expected to demonstrate ongoing maintenance of competence within their role. Evidence can include performance reviews, GCP certification, participation in study activity, or engagement in professional development opportunities. The NIHR and RCGP provide a wealth of learning resources, including online courses, workshops, and conferences, which can be used to support appraisal and professional development. In addition, GPs should stay informed of changes in legislation, regulatory guidance, and best practice standards, ensuring that research is conducted ethically, safely, and in accordance with national and local governance requirements.

The GPwER in Research Delivery occupies a distinctive and influential role within the research landscape. It offers the opportunity to build strong, collaborative relationships with study teams led by Chief Investigators, often senior academic clinicians, including GPs and secondary care specialists, as well as experienced research delivery teams from the NIHR RDN secondary care colleagues, and representatives from the UK Life Sciences industry. In England, studies adopted onto the NIHR portfolio are recognised as having the potential to benefit the NHS and patient care, and participation in these studies carries both professional significance and reputational value for the GP.

The national research networks, including NIHR RDN in England, Health and Care Research Wales, NHS Research Scotland, and the Northern Ireland Clinical Research Network, play a central role in supporting GPwERs in research delivery. They provide essential resources, study support, professional development opportunities, and research expertise, enabling GPs to deliver high-quality research effectively. Developing and maintaining these relationships is fundamental to the success of the GPwER role, ensuring integration with the wider research infrastructure across the UK.

One of the advantages of clinical research delivery is its flexibility, which allows GPs to contribute according to their capacity and interests. The time commitment varies between studies, enabling a practice to support a few or multiple studies concurrently. The workload often differs across the study lifecycle, with greater effort typically required during the initiation and setup phases compared to the follow-up or maintenance stages. For example, PIC  studies are generally less time-intensive, involving electronic record searches and patient invitations. In contrast, other interventional or complex studies may demand more substantial involvement throughout their duration. This includes follow up data collection, monitoring and archiving after the study has been delivered.

Effective delivery of clinical research can provide GP practices with a valuable source of income, particularly when supporting studies sponsored by the Life Sciences industry. These funds can be used to backfill clinical duties or to allocate dedicated time for research activities, enabling practices to build sustainable research capacity.

The GPwER in research delivery can be undertaken by all GPs, whether partners, salaried, sessional, or registrar. This provides flexible opportunities to engage with research regardless of employment model.

In addition, national Clinical Research Networks often provide supplementary support, including funding, training, and resources, to help GPs conduct research. This support is particularly valuable when establishing research activity within a practice, helping to develop the skills, infrastructure, and experience needed for ongoing, high-quality participation.

Sustainability is a key consideration in the delivery of clinical research within general practice, and the GPwER in Research Delivery can play an essential role in supporting it. By engaging in high-quality research, GPs can contribute to the generation of evidence that improves care efficiency, reduces waste, and supports the prudent use of healthcare resources, aligning with the RCGP’s principles on sustainability and the avoidance of overdiagnosis.

Through careful study selection and delivery, GPwERs can help ensure that research provides meaningful benefit to patients, the practice, and the wider health system. This aligns with the concept of quadruple value, which emphasises clinical effectiveness, patient experience, cost-effectiveness, and workforce well-being. By embedding these principles into research activities, GPwERs can help ensure that clinical studies not only advance scientific knowledge but also support sustainable, high-value care in primary care settings.

Equity, diversity, and inclusion (EDI) are fundamental to all aspects of general practice, including the delivery of clinical research. All GPs and GP practices, regardless of size or location, can participate in research. It is essential to consider how research opportunities are offered within the practice and how different communities are engaged, ensuring that all patient groups have fair access to participate. Promoting equity in research participation is vital to achieving meaningful and generalisable study outcomes. All patients should, if eligible, have the opportunity to participate in a research study.

This is an area that requires much focus in the wider research community as research is often focused in populations lacking diversity who are more socioeconomically advantaged.  Many studies include specific targets for recruiting participants from diverse backgrounds, reflecting the importance of inclusive recruitment practices in generating robust and representative evidence. The GPwER can play a key role in achieving true study inclusivity (locally and nationally). They have an expert understanding of the health and care needs of their community and have a unique relationship and trust with patients that enables them to access those harder to reach communities.