scholarly journals Setting up clinical research studies in the National Health Service in England

2016 ◽  
Vol 10 (2) ◽  
pp. 145-147 ◽  
Author(s):  
Jessica Whitburn ◽  
Surjeet Singh ◽  
Prasanna Sooriakumaran

Starting and conducting clinical trials in England can be a complicated and time-consuming process. Before your study can begin it is necessary to gain approval from the appropriate regulatory bodies. Prior to March 2016, studies required National Health Service (NHS) permission (also referred to as Research and Development (R&D) approval) obtained via the National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP). Since March 2016, a new streamlined system has been introduced with the aim of making it easier to gain regulatory approvals. Now studies must go through the process of Health Research Authority (HRA) approval. In this article we review the process of gaining HRA approval in England. The article is aimed at junior researchers to help them understand the application process, and to give tips on how to succeed in gaining approval.

2005 ◽  
Vol 29 (12) ◽  
pp. 447-448 ◽  
Author(s):  
George Szmukler

Chilvers & Clark make it clear that research and development (R&D) in the National Health Service (NHS) is now a managed process. There is a coherent strategy and much thought has been given to the use of resources. I welcome this development and the ‘Health Research System’ that forms its framework.


Lung Cancer ◽  
2013 ◽  
Vol 81 (2) ◽  
pp. 236-240 ◽  
Author(s):  
Francesco Grossi ◽  
Carlo Genova ◽  
Nidia Diaz Gaitan ◽  
Maria Giovanna Dal Bello ◽  
Erika Rijavec ◽  
...  

2014 ◽  
Vol 38 (1) ◽  
pp. 19-23 ◽  
Author(s):  
Alex J. Mitchell ◽  
John Gill

Aims and methodTo examine research productivity of staff working across 57 National Health Service (NHS) mental health trusts in England. We examined research productivity between 2010 and 2012, including funded portfolio studies and all research (funded and unfunded).ResultsAcross 57 trusts there were 1297 National Institute for Health Research (NIHR) studies in 2011/2012, involving 46140 participants and in the same year staff in these trusts published 1334 articles (an average of only 23.4 per trust per annum). After correcting for trust size and budget, the South London and Maudsley NHS Foundation Trust was the most productive. In terms of funded portfolio studies, Manchester Mental Health and Social Care Trust as well as South London and Maudsley NHS Foundation Trust, Oxford Health NHS Foundation Trust and Cambridgeshire and Peterborough NHS Foundation Trust had the strongest performance in 2011/2012.Clinical implicationsTrusts should aim to capitalise on valuable staff resources and expertise and better support and encourage research in the NHS to help improve clinical services.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Virginia Minogue ◽  
Karen Matvienko-Sikar ◽  
Catherine Hayes ◽  
Mary Morrissey ◽  
Gregory Gorman ◽  
...  

Abstract Background Translating research findings into service improvements for patients and/or policy changes is a key challenge for health service organizations. The Health Service Executive (HSE) in Ireland launched the Action Plan for Health Research 2019–2029, as reported by Terrés (HSE, Dublin, 2019), one of the goals of which is to maximize the impact of the research that takes place within the service to achieve improvements in patient care, services, or policy change. The purpose of this research is to review the literature on knowledge translation theories, models, and frameworks (TMFs) and to assess the suitability of the TMFs for HSE use, selecting one or more for this purpose. The aim is to produce guidance for HSE researchers and other health services staff, validate the usability of the framework(s) with researchers, and review and implement the guidance. It was hoped that identifying a suitable methodology would provide the means to increase the uptake and application of research findings, and reduce research wastage. This paper reports on the first part of the study: the review, assessment, and selection of knowledge translation TMFs for a national health service. Methods An interdisciplinary working group of academic experts in implementation science, research wastage, and knowledge translation, along with key representatives from research funders (Health Research Board) and HSE personnel with expertise in quality improvement and research management, undertook a three-stage review and selection process to identify a knowledge translation TMF that would be suitable and usable for HSE purposes. The process included a literature review, consensus exercise, and a final consensus workshop. The review group adopted the Theory Comparison and Selection Tool (T-CaST) developed by Birken et al. (Implement Sci 13: 143, 2018) to review knowledge translation theories, models, and frameworks. Results From 247 knowledge translation TMFs initially identified, the first stage of the review identified 18 that met the criteria of validity, applicability, relevance, usability, and ability to be operationalized in the local context. A further review by a subgroup of the working group reduced this number to 11. A whole-group review selected six of these to be reviewed at a facilitated consensus workshop, which identified three that were suitable and applicable for HSE use. These were able to be mapped onto the four components of the HSE knowledge translation process: knowledge creation, knowledge into action, transfer and exchange of knowledge, and implementation and sustainability. Conclusion The multiplicity of knowledge translation TMFs presents a challenge for health service researchers in making decisions about the appropriate methods for disseminating their research. Building a culture that uses research knowledge and evidence is important for organizations seeking to maximize the benefits from research. Supporting researchers with guidance on how to disseminate and translate their research can increase the uptake and application of research findings. The use of robust selection criteria enabled the HSE to select relevant TMFs and develop a process for increasing the dissemination and translation of research knowledge. The guidance developed to inform and educate researchers and knowledge users is expected to increase organizational capacity to promote a culture of research knowledge and evidence use within the HSE.


2016 ◽  
Vol 22 (1) ◽  
pp. 64-72
Author(s):  
Miriam Cooper ◽  
Olga Eyre ◽  
Joanne Doherty ◽  
Rhys Bevan Jones

SummaryWhen embarking on mental health research it is often necessary to apply for approvals from one or more review bodies to ensure that the research is ethical and that the safety and well-being of participants are safeguarded. This can be complicated and time consuming, particularly to those unfamiliar with the process. In this article we describe the approvals commonly required for National Health Service-based research involving patients and endeavour to clearly explain what is involved at each stage. We then highlight some of the main considerations, including ethical aspects, which are particularly pertinent to conducting research in the field of mental health, and finish with general advice and considerations for future developments in the area.


2020 ◽  
pp. 000486742097326
Author(s):  
Catherine Henshall ◽  
Jennifer Potts ◽  
Sophie Walker ◽  
Mark Hancock ◽  
Mark Underwood ◽  
...  

Objective: Recruitment to clinical research in the National Health Service remains challenging. One barrier is accessing patients to discuss research participation. Two general approaches are used in the United Kingdom to facilitate this: an ‘opt-in’ approach (when clinicians communicate research opportunities to patients) and an ‘opt-out’ approach (all patients have the right to be informed of relevant research opportunities). No evidence-based data are available, however, to inform the decision about which approach is preferable. This study aimed to collect information from ‘opt-in’ and ‘opt-out’ Trusts and identify which of the two approaches is optimal for ensuring National Health Service patients are given opportunities to discuss research participation. Method: This sequential mixed methods study comprised three phases: (1) an Appreciative Inquiry across UK Trusts, (2) online surveys and (3) focus groups with National Health Service staff and patients at a representative mental health Trust. Results: The study was conducted between June and October 2019. Out of seven National Health Service Mental Health Trusts contacted (three ‘opt-out’ and four ‘opt-in’), only four took part in phase 1 of the study and three of them were ‘opt-out’ Trusts. Benefits of an ‘opt-out’ approach included greater inclusivity of patients and the removal of research gatekeepers, while the involvement of research-active clinicians and established patient–clinician relationships were cited as important to ‘opt-in’ success. Phases 2 and 3 were conducted at a different Trust (Oxford Health NHS Foundation Trust) which was using an ‘opt-in’ approach. Of 333 staff and member survey responders, 267 (80.2%) favoured moving to an ‘opt-out’ approach (phase 2). Nineteen staff and 16 patients and carers participated in focus groups (phase 3). Concern was raised by staff regarding the lack of time for clinical research, with clinical work taking precedence over research; patients were concerned about a lack of research activity; all considered research to be beneficial and were supportive of a move to ‘opt-out’. Conclusion: Findings suggest that ‘opt-out’ is more beneficial than ‘opt-in’, with the potential to vastly increase patient access to research opportunities and to enable greater equality of information provision for currently marginalised groups. This should ensure that healthcare research is more representative of the entire population, including those with a mental health diagnosis.


Rheumatology ◽  
2017 ◽  
Vol 56 (suppl_2) ◽  
Author(s):  
Izolda Biro ◽  
Simon Donnelly ◽  
Carey Tierney ◽  
Hasan Tahir ◽  
Judith Bubbear

Sign in / Sign up

Export Citation Format

Share Document