Research Governance Framework Research Articles

Pushing health data access boundaries - adapting NHS governance for 3 challenges: clinical free-text, safe commercial access and AI development

This presentation will demonstrate expansions to TRE governance frameworks developed to facilitate safe data access in three advanced areas: commercial access, clinical free-text, and innovation with AI/Machine Learning. NHS research governance frameworks - originally set up for clinical trials and expanded into the TRE and secondary data use space – are not an immediate fit for advanced techniques in data science research. Over 2 years, public, expert and user engagement approaches were utilised to support developing frameworks within DataLoch, a Health and Social Care TRE and data access service in South-East Scotland. Surveys, workshops and continuous user and data controller feedback allowed the testing of tools and assessments to adapt traditional NHS governance structures. These frameworks utilise the Five Safes framework to make NHS data controllers supportive of innovative research in the public and health service’s benefit. The presentation will summarise the challenges faced for one TRE and researchers working to support these areas, and the frameworks that are now are being tested within an NHS Scotland Health Board. The development and implementation demonstrates that governance structures can be adapted collaboratively and paves the way for more flexible TRE governance to allow the use of NHS patient data to remain legally and ethically robust while supporting advanced techniques of analysis.

Review of Foods from Genetically Modified Agricultural Product

Genetically modified (GM) foods have emerged as a significant force in agriculture, offering transformative potential to address pressing global issues such as food security, malnutrition, and environmental sustainability. This comprehensive review delves into the multifaceted landscape of GM foods, examining advancements in crop improvement, environmental impact, food safety, nutraceuticals, and consumer perception. GM technologies have facilitated notable enhancements in agricultural productivity and resilience, with crops exhibiting increased yields and resistance to environmental stresses. Furthermore, biofortification initiatives have the potential to alleviate malnutrition by enhancing the nutritional content of staple crops. Additionally, the development of functional foods through genetic modification holds promise for promoting health and wellness. However, the widespread adoption of GM foods also raises ethical, health, and safety concerns, as well as challenges related to consumer acceptance. It is imperative that rigorous research, transparent communication, and responsible governance frameworks are in place to address these issues effectively. This review navigates through diverse perspectives to offer a nuanced understanding of GM foods, recognizing both their opportunities and challenges. By providing insights into the ethical dilemmas and complexities surrounding GM technologies, it aims to facilitate informed decision-making, guide policy development, and inform future research initiatives. Ultimately, the review underscores the importance of balancing innovation with ethical considerations and public concerns to ensure the sustainable and responsible deployment of GM foods in agriculture.

Developing a Framework for Self-regulatory Governance in Healthcare AI Research: Insights from South Korea

This paper elucidates and rationalizes the ethical governance system for healthcare AI research, as outlined in the ‘Research Ethics Guidelines for AI Researchers in Healthcare’ published by the South Korean government in August 2023. In developing the guidelines, a four-phase clinical trial process was expanded to six stages for healthcare AI research: preliminary ethics review (stage 1); creating datasets (stage 2); model development (stage 3); training, validation, and evaluation (stage 4); application (stage 5); and post-deployment monitoring (stage 6). Researchers identified similarities between clinical trials and healthcare AI research, particularly in research subjects, management and regulations, and application of research results. In the step-by-step articulation of ethical requirements, this similarity benefits from a reliable and flexible use of existing research ethics governance resources, research management, and regulatory functions. In contrast to clinical trials, this procedural approach to healthcare AI research governance effectively highlights the distinct characteristics of healthcare AI research in research and development process, evaluation of results, and modifiability of findings. The model exhibits limitations, primarily in its reliance on self-regulation and lack of clear delineation of responsibilities. While formulated through multidisciplinary deliberations, its application in the research field remains untested. To overcome the limitations, the researchers’ ongoing efforts for educating AI researchers and public and the revision of the guidelines are expected to contribute to establish an ethical research governance framework for healthcare AI research in the South Korean context in the future.

Planning, implementing and governing systems-based co-creation: the DISCOVER framework

BackgroundIncreasingly, public health faces challenges requiring complex, multifaceted and multi-sectoral responses. This calls for systems-based approaches that facilitate the kind of collective and collaborative thinking and working required to address complexity. While the literature on systems thinking, system dynamics and the associated methodologies is extensive, there remains little clear guidance on how to plan, govern and implement participatory systems approaches within a co-creation process.MethodsWe used a three-step process to develop DISCOVER, a framework for implementing, and governing systems-based co-creation:Stage 1: We conducted a literature analysis of key texts to identify well-documented methods and phases for co-creation using a systems approach, as well as areas where gaps existed.Stage 2: We looked for the most appropriate methods and approaches to fill the gaps in the knowledge production chain.Stage 3: We developed the framework, identifying how the different tools and approaches fit together end-to-end, from sampling and recruiting participants all the way through to responding with an action plan.ResultsWe devised DISCOVER to help guide researchers and stakeholders to collectively respond to complex social, health and wider problems. DISCOVER is a strategic research planning and governance framework that provides an actionable, systematic way to conceptualise complex problems and move from evidence to action, using systems approaches and co-creation. In this article, we introduce the eight-step framework and provide an illustrative case study showcasing its potential. The framework integrates complementary approaches and methods from social network analysis, systems thinking and co-creation literature. The eight steps are followed sequentially but can overlap.ConclusionsDISCOVER increases rigour and transparency in system approaches to tackling complex issues going from planning to action. It is being piloted in environmental health research but may be suitable to address other complex challenges and could be incorporated into research proposals and protocols for future projects.

PP07 Improving The Use Of Real-World Evidence In The Development Of NICE Guidance

IntroductionThe National Institute for Health and Care Excellence (NICE) is determined to make better use of health and social care data in the development of its guidance. Real-world data (RWD) has the potential to significantly improve our understanding of the value of new and existing health and social care interventions. RWD is already widely used to characterize populations, interventions, and outcomes and to populate economic models, but its use in estimating the effects of interventions remains limited, especially for medicines. Key barriers to its greater use in this context include limited transparency around studies, sometimes a lack of confidence in their integrity, and methodological concerns around how studies have addressed major sources of potential bias.MethodsThis abstract focuses on the real-world evidence (RWE) framework developed by NICE to support its ambitions. The framework was developed in an iterative way based on: reviews of best practice approaches to the conduct and assessment of real-world evidence studies; case studies; and workshops with key external stakeholders. The initial version of this living framework focuses on de novo RWE studies using individual patient data.ResultsThe RWE framework consists of an overarching research governance framework which describes expectations around the planning, conduct, and reporting of RWE studies across uses of real-world data. Uses are categorized by risk according to their importance to decision-making, the impact of decisions on patient and system outcomes, and their complexity as proxied by risk of bias. Studies of the effects of interventions on patient health and system outcomes are considered the highest risk. The research governance framework is supported by a tool to aid assessment of data suitability for its intended application, and detailed guidance on the conduct and reporting of comparative effect studies using RWD, following the target trial approach.ConclusionsThe RWE Framework underpins NICE’s ambitions to make better use of RWD in its guidance and is intended to improve the quality and utility of RWE studies submitted to NICE enabling more consistent and appropriate evaluation.

The role of Participatory Action Research in developing new models of healthcare: Perspectives from participants and recommendations for ethical review and governance oversight

Participatory Action Research (PAR) is a methodology often used in social sciences, which involves groups of people in action, reflection and iterative change. In PAR, ‘traditional’ researchers become participants, and people who comprise ‘traditional’ participants become researchers, facilitating cohesiveness and communication within the team. However, PAR is less used in healthcare, despite the complexity of providing and receiving health and social care. Development and testing of the delivery of new models of care is an area with increasing service-user participation, but often with no structured or formalised framework to embed end-users. This may be due in part to the complex ethical and governance systems in healthcare research, and the lack of practical guidance on using PAR as a research method within this context. We carried out a PAR project to develop and evaluate the implementation of a new model of care for the assessment and management of respiratory conditions in the community (MISSION ABC). The care model delivered a community-based multidisciplinary clinic involving healthcare staff from both primary and secondary care. Regular sessions were held for participants (including patients, healthcare staff, research staff) to discuss observations, reflections and suggestions for the development and delivery of the care model. At the end of the project, meetings were held with representatives from the different groups of participants to discuss overall views about the study and ethics and research governance challenges specifically. We present key perspectives from various stakeholders involved in the PAR process, highlighting benefits and challenges. Specific challenges relating to ethical and governance approvals encountered in the set-up and delivery of the project are described. These include the design of the study protocol, approaches to consent, presentation of study information within the current ethical and regulatory frameworks and maintaining the flexibility of study methods and roles of participants throughout the study period. Recommendations for improvement in the research pathway that PAR researchers could adopt to enable a meaningful and successful PAR approach are made, in addition to suggestions for overarching ethics and governance frameworks. Developing new models of healthcare benefits significantly from collaboration with stakeholders so that the design and delivery are feasible and acceptable to all. However, the current UK research approvals and governance frameworks present challenges to design and successfully deliver PAR studies in healthcare; we present possible solutions.

Governance of health research in four eastern and southern African countries

BackgroundHealth research governance is an essential function of national health research systems. Yet many African countries have not developed strong health research governance structures and processes. This paper presents a comparative analysis of national health research governance in Botswana, Kenya, Uganda and Zambia, where health sciences research production is well established relative to some others in the region and continues to grow. The paper aims to examine progress made and challenges faced in strengthening health research governance in these countries.MethodsWe collected data through document review and key informant interviews with a total of 80 participants including decision-makers, researchers and funders across stakeholder institutions in the four countries. Data on health research governance were thematically coded for policies, legislation, regulation and institutions and analysed comparatively across the four national health research systems.ResultsAll countries were found to be moving from using a research governance framework set by national science, technology and innovation policies to one that is more anchored in health research structures and policies within the health sectors. Kenya and Zambia have adopted health research legislation and policies, while Botswana and Uganda are in the process of developing the same. National-level health research coordination and regulation is hampered by inadequate financial and human resource capacities, which present challenges for building strong health research governance institutions.ConclusionBuilding health research governance as a key pillar of national health research systems involves developing stronger governance institutions, strengthening health research legislation, increasing financing for governance processes and improving human resource capacity in health research governance and management.

Multifactorial Falls Prevention Programme Compared to Routine Care in Long Term Older Care Residents (FinCH): A Multi-Centre Cluster Randomised Controlled Trial with Economic Evaluation

Background: Falls are three times more common for care home residents than for similarly aged people living at home, often causing hospital admission and death. The Guide to Action for Care Homes (GtACH) is a multifactorial programme designed to prevent falls in care homes. Methods: A multi-centre, cluster (care home) randomised controlled trial to evaluate the clinical and cost-effectiveness of the GtACH programme compared to usual care. The primary health outcome was fall rate between 91 and 180 days from randomisation. Secondary outcomes included dependency (Barthel ADL Index) and activity (Physical Activity Measure – Residential Care Homes (PAM-RC)) at 90, 180, 270 and 360 days from randomisation. Cost effectiveness was estimated adopting a UK National Health Service and personal social services perspective, measuring health-related quality of life using quality adjusted life years (QALYs) derived from the EQ-5D-5L-Proxy and DEMQOL-Proxy-U until 12 months post-randomisation. Findings: 84 care homes were randomised (39 GtACH, 45 usual care). 1657 residents consented and provided baseline measures, mean age 85 years, 32% men. GtACH training was delivered to 1051 staff (71%). Primary RCT outcome data were available for 630 GtACH participants and 712 usual care participants. The unadjusted Incidence Rate Ratio for falls between 91-180 days was 0.57 (95% CI 0.45-0.71, p<0.01) in favour of the GtACH programme (GtACH: 6 falls/1000 residents versus 10.4/1000 in usual care). Barthel ADL Indices and PAM-RC scores were similar between groups at all-time points. The incremental cost was £108 (95% CI -271.06, 487.58), incremental QALYs gained were 0.024 (95% CI 0.004, 0.044) and 0.005 (95% CI -0.019, 0.03) for EQ-5D-5L-P and DEMQOL-P-U respectively. The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4,544 and £20,889 respectively. Interpretation: The GtACH programme reduced the fall rate and was cost-effective, without reducing activity or increasing dependency. Trial Registration: Trial registration number: ISRCTN34353836. Protocol V6 14 November 2017 Funding: This work was funded by NIHR HTA (Project number 13/115/29). Declaration of Interest: Profs Logan, Armstrong, Gladman, Gordon, Leighton, Mountain, Sach have nothing to disclose. Drs Horne, Allen, Clark, Conroy, Darby, Fox, Irvine, McCartney, Robinson, Wilson, Sims, have nothing to disclose. Mrs Godfrey and Robertson have nothing to disclose. Ethical Approval: The trial was not initiated before the protocol, informed consent forms and participant information sheets received approval / favourable opinion from the Research Ethics Committee (REC), and the National Health Service (NHS) Research & Development (RD the principles of Good Clinical Practice, and the Department of Health Research Governance Framework for Health and Social care, 2005

Protocol for an implementation study of an evidence-based home cardiac rehabilitation programme for people with heart failure and their caregivers in Scotland (SCOT:REACH-HF)

IntroductionDespite evidence that cardiac rehabilitation (CR) is an essential component of care for people with heart failure, uptake is low. A centre-based format is a known barrier, suggesting that home-based...

Relational ethics in palliative care research: including a person-centred approach.

The traditional approach to research ethics is to ensure that all ethical issues are adhered to through the scrutiny of research proposals by research ethics committees, themselves sitting within national research governance frameworks. The current approach implies that all potential ethical issues can be considered and mitigated prior to the research. This article is a perspective piece whereby we consider how this approach, on its own, is not enough to ensure ethical practice. We draw attention to the limitations of current ethical procedures in the inherent detachment between the researcher and research participants. We argue that applying a person-centred approach to research ethics allows for contextual and situational factors and places the relationship between research participants and researcher as central.

Stratified prevention: opportunities and limitations. Report on the 1st interdisciplinary cardiovascular workshop in Augsburg

Sufficient exercise and sleep, a balanced diet, moderate alcohol consumption and a good approach to handle stress have been known as lifestyles that protect health and longevity since the Middle Age. This traditional prevention quintet, turned into a sextet by smoking cessation, has been the basis of the “preventive personality” that formed in the twentieth century. Recent analyses of big data sets including genomic and physiological measurements have unleashed novel opportunities to estimate individual health risks with unprecedented accuracy, allowing to target preventive interventions to persons at high risk and at the same time to spare those in whom preventive measures may not be needed or even be harmful. To fully grasp these opportunities for modern preventive medicine, the established healthy life styles require supplementation by stratified prevention. The opportunities of these developments for life and health contrast with justified concerns: A “surveillance society”, able to predict individual behaviour based on big data, threatens individual freedom and jeopardises equality. Social insurance law and the new German Disease Prevention Act (Präventionsgesetz) rightly stress the need for research to underpin stratified prevention which is accessible to all, ethical, effective, and evidence based. An ethical and acceptable development of stratified prevention needs to start with autonomous individuals who control and understand all information pertaining to their health. This creates a mandate for lifelong health education, enabled in an individualised form by digital technology. Stratified prevention furthermore requires the evidence-based development of a new taxonomy of cardiovascular diseases that reflects disease mechanisms. Such interdisciplinary research needs broad support from society and a better use of biosamples and data sets within an updated research governance framework.

A case study comparing research integrity, governance and ethics frameworks to facilitate collaboration between Bristol and Kyoto University

Researchers and non-commercial institutions negotiate complex legislation and guidance when planning and conducting research studies. The documents and processes required differ across nations and their regulatory bodies and it can be challenging to conduct an international study, especially for non-commercial organisations. In this study, colleagues from Japan and the UK worked closely together focusing on the legislation, organisations, trial processes, ethics review and quality assurance frameworks of clinical trials in two countries, the UK, demonstrated on the model of practices in the University of Bristol and University Hospital Bristol NHS Foundation Trust, and Japan, based on the model in Kyoto University Hospital. Although the ICH tripartite guidelines (ICH-GCP) were developed with participation from both the EU and Japan the set-up and approval processes for clinical trials are different between the two countries while the expectations for quality assurance are similar. We will argue that the framework in the UK is well-developed for performing multi-centre trials both, commercially and non-commercially sponsored. Japan has an excellent infrastructure to conduct early phase trials and commercially sponsored trials. Multi-centre investigator led trials are currently a challenge due to the complex and resource intense approval systems. A good model for collaboration between Bristol and Kyoto might be where early translational studies are set-up in Japan and later phases of the studies are conducted in the UK.

Working with bacteria and putting bacteria to work: The biopolitics of synthetic biology for energy in the United Kingdom

The UK government has made significant investment into so called ‘fourth-generation’ biofuel technologies. These biofuels are based on engineering the metabolic pathways of bacteria in order to create products compatible with existing infrastructure. Bacteria play an important role in what is promoted as a potentially new biological industrial revolution, which could address some of the negative environmental legacies of the last. This article presents results from ethnographic research with synthetic biologists who are challenged with balancing the curiosity-driven and intrinsically fulfilling scientific task of working with bacteria, alongside the policy-driven task of putting bacteria to work for extrinsic economic gains. In addition, the scientists also have to balance these demands with a new research governance framework, Responsible Research and Innovation, which envisions technoscientific innovation will be responsive to societal concerns and work in collaboration with stakeholders and members of the public. Major themes emerging from the ethnographic research revolve around stewardship, care, responsibility and agency. An overall conflict surfaces between individual agents assuming responsibility for ‘stewarding’ bacteria, against funding systems and structures imposing responsibility for economic growth. We discuss these findings against the theoretical backdrop of a new concept of ‘energopolitics’ and an anthropology of ethics and responsibility.

Small is beautiful: demystifying and simplifying standard operating procedures: a model from the ethics review and consultancy committee of the Cameroon Bioethics Initiative.

BackgroundResearch ethics review is a critical aspect of the research governance framework for human subjects research. This usually requires that research protocols be submitted to a research ethics committee (REC) for review and approval. This has led to very rapid developments in the domain of research ethics, as RECs proliferate all over the globe in rhyme with the explosion in human subjects research. The work of RECs has increasingly become elaborate, complex, and in many cases urgent, necessitating supporting rules and procedures of operation. Guidelines for elaborating standard operating procedures (SOPs) for the functioning of RECs have also been proposed. The SOPs of well-placed and well-resourced RECs have tended to pay much attention to details, resulting, as a consequence, in generally long, elaborate, intricate and complex SOPs; a model that can hardly be replicated by other committees, equally under ethics review pressures, but working under much more constraining conditions in resource-destitute environments.MethodsIn this paper, we looked at the content and length of SOPs from African RECs and compared them to the World Health Organization (WHO)’s guidelines as the gold standard. We also looked at the SOPs from the Ethics Review and Consultancy Committee (ERCC) of the Cameroon Bioethics Initiative that we elaborated in a simplified way in 2013, and compared them to the WHO’s guidelines and to the other SOPs.ResultsSixteen SOPs from 14 African countries were collected from various sources. Their average length was of 30 pages. By comparison to the guidance of the WHO, only six of them were found acceptable with more than 70 % of the criteria from the gold standard that were fully described. Among those six, two of them were very long and detailed (65 and 102 pages), while the four remaining SOPs ranged from 16 to 24 pages. The ERCC SOPs are seven pages long but maintain all that is of essence for the rigorous, efficient and timely review of protocols.ConclusionsWe are convinced that, because of their brevity, simplicity, clarity and user-friendliness, the ERCC SOPs recommend themselves as a model template to, at least, committees similarly situated and/or circumstanced as the ERCC of the Cameroon Bioethics Initiative is. In fact, brevity, clarity, simplicity and user-friendliness are recognized values. Whatever is brief and clear is better than what is not and saves time. What is simple and user-friendly is better than what is not even though the two have the same aims because it saves both time and mental energy. And if this be true in general, it is even truer of the context and its peculiar constraints that we are addressing.

Researching the Mental Capacity Act 2005: reflections on governance, field relationships, and ethics with an adult who did not consent

The Mental Capacity Act 2005 codified procedures for involving incapacitated adults in research, set out statutory cognitive assessments, and established legality for studies in which participants cannot consent to their participation. While the general debates about the efficacy of Research Governance Frameworks are polarized and rehearsed, little has been written about the ethics and field relations of qualitative research with adults lacking capacity. Drawing on data from fieldwork with Abrax, a young man classified as ‘profoundly learning disabled’ who did not communicate verbally and required support to meet his physical needs, the process of seeking ethical approval is described. There is also a reflection on developing a relationship with Abrax, assessing his mental capacity to partake in research; and dealing with the ethical implications of uncertainty about his decision-making abilities. The thrust of the paper is support for the principle of regulating research with incapacitated adults while making the argument that a relationship-based ethical approach is a necessary augmentation to the current framework.

Discontinuation and non-publication of surgical randomised controlled trials: observational study

Objective To determine the rate of early discontinuation and non-publication of randomised controlled trials involving patients undergoing surgery.Design Cross sectional observational study of registered and published trials.Setting Randomised controlled trials...

Everyday ethics in community-based participatory research

This article explores a range of ethical issues that arise in community-based participatory research (CBPR), drawing on literature and examples from practice. The experience of CBPR practitioners adds further weight to the growing critique by many other social researchers of regulatory approaches to research ethics (which focus on rule following in accordance with research governance frameworks, codes of conduct and ethics review procedures). Yet, whilst many of the ethical challenges in CBPR are common to social research generally (informed consent, anonymity, issues of ownership of data and findings), the dynamic, complex and value-based nature of CBPR gives them particular prominence. There are also specific issues relating to the ethics of partnership working, collaboration, blurring of boundaries between researchers and researched, community rights, community conflict and democratic participation that are more frequently encountered in CBPR. Four practice examples are used to demonstrate this argument. These are taken from a young women's community allotment, a community organisation researching poverty, a youth peer research project and a museum-based digital storytelling project. The article concludes that current institutional ethical codes, guidelines and ethical review procedures are not particularly well-suited to CBPR, in that they adopt principle-based and regulatory approaches to ethics; whereas character- and relationship-based approaches to ethics are also very important in CBPR, which is adopted by many researchers with a strong value commitment to social justice.

Understanding the research process in school nursing

British Journal of School NursingVol. 7, No. 9 Research in PracticeUnderstanding the research process in school nursingPenny FarrellyPenny FarrellySearch for more papers by this authorPenny FarrellyPublished Online:16 Aug 2013https://doi.org/10.12968/bjsn.2012.7.9.457AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References Department of Health (2005) Research Governance Framework for Health and Social Care. www.dh.gov.uk/assetRoot/04/10/89/65/04108965.xml (accessed 1 November 2012) Google Scholar Moule P, Goodman M (2009) Nursing Research: An Introduction. Sage, London Google Scholar Parahoo K (2006) Nursing Research: Principles, Process and Issues. 2nd edition. Palgrave Macmillan, Basingstoke Google Scholar FiguresReferencesRelatedDetailsCited byThe incorporation of research into a 2-year practical nursing diploma programTeaching and Learning in Nursing, Vol. 10, No. 1 1 November 2012Volume 7Issue 9ISSN (print): 1752-2803ISSN (online): 2052-2827 Metrics History Published online 16 August 2013 Published in print 1 November 2012 Information© MA Healthcare LimitedPDF download

Procedure versus process: ethical paradigms and the conduct of qualitative research.

BackgroundResearch is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups.DiscussionMuch criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness of evaluating qualitative studies within the methodological and risk assessment frameworks applied to biomedical and clinical research. Less attention has been given to the different epistemologies underlying biomedical and qualitative investigation. The bioethical framework underpinning current regulatory structures is fundamentally at odds with the practice of emergent, negotiated micro-ethics required in qualitative research. The complex and shifting nature of real world settings delivers unanticipated ethical issues and (occasionally) genuine dilemmas which go beyond easy or formulaic ‘procedural’ resolution. This is not to say that qualitative studies are ‘unethical’ but that their ethical nature can only be safeguarded through the practice of ‘micro-ethics’ based on the judgement and integrity of researchers in the field.SummaryThis paper considers the implications of contrasting ethical paradigms for the conduct of qualitative research and the value of ‘empirical ethics’ as a means of liberating qualitative (and other) research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism, divorced from real world contexts and values.

Bureaucracy stifles medical research in Britain: a tale of three trials.

BackgroundRecent developments aiming to standardise and streamline processes of gaining the necessary approvals to carry out research in the National Health Service (NHS) in the United Kingdom (UK), have resulted in lengthy and costly delays. The national UK governmental Department of Health’s Research Governance Framework (RGF) for Health and Social Care requires that appropriate checks be conducted before research involving human participants, their organs, tissues or data can commence in the NHS. As a result, medical research has been subjected to increased regulation and governance, with the requirement for approvals from numerous regulatory and monitoring bodies. In addition, the processes and outcomes of the attribution of costs in NHS research have caused additional difficulties for researchers. The purpose of this paper is to illustrate, through three trial case studies, the difficulties encountered during the set-up and recruitment phases of these trials, related to gaining the necessary ethical and governance approvals and applying for NHS costs to undertake and deliver the research.MethodsEmpirical evidence about delays and difficulties related to regulation and governance of medical research was gathered during the period 2009–2010 from three UK randomised controlled trials with sites in England, Wales and Scotland (1. SAFER 2- an emergency care based trial of a protocol for paramedics to refer patients directly to community based falls services; 2. COnStRUCT- a trial of two drugs for acute ulcerative colitis; and 3. Family Links - a trial of a public health intervention, a 10 week community based parenting programme). Findings and recommendations were reported in response to a call for evidence from The Academy of Medical Sciences regarding difficulties encountered in conducting medical research arising from R&D governance and regulation, to inform national policy.ResultsDifficulties and delays in navigating and gaining the appropriate approvals and NHS costs required to undertake the research were encountered in all three trials, at various points in the bureaucratic processes of ethical and research and information governance approvals. Conduct of each of the three trials was delayed by at least 12 months, with costs increasing by 30 – 40%.ConclusionsWhilst the three trials encountered a variety of challenges, there were common issues. The processes for gaining approvals were overly complex and differed between sites and UK countries; guidance about processes was unclear; and information regarding how to define and claim NHS costs for undertaking the research was inconsistent. The competitive advantage of a publicly funded, open access health system for undertaking health services research and clinical trials within the UK has been outweighed in recent years by stifling bureaucratic structures and processes for governance of research. The recommendations of the Academy of Medical Sciences are welcomed, and the effects of their implementation are awaited with interest.Trial Registration numbersSAFER 2: ISRCTN 60481756; COnStRUCT: ISRCTN22663589; Family Links: ISRCTN 13929732