UK Regulations Research Articles

Noise in operating theatres, is it safe?

Noise-Induced Hearing Loss (NIHL) is a condition caused by repeated exposure to loud noise, with operating theatre personnel potentially at risk. The aims of this study were to establish the typical noise levels in orthopaedic theatres and to compare these to The Control of Noise at Work Regulations 2005. We measured the average noise levels in 40 trauma and orthopaedic surgeries in a single centre. We used the Decibel X app to take measurements, then performed corrections to ascertain noise levels at the surgeon's ear (Leq). The daily noise exposure level for theatre staff for each procedure (LEP, d) and the LEP, d over an average 8-hour working day when performing different groups of procedures were calculated. Data were analysed using descriptive statistics, ANOVA, t-test and the Pearson coefficient of correlation. The LEP, d lower action value (80 dBA) as set by the Health and Safety Executive (HSE) was met by performing a single revision total knee replacement or a right open ankle debridement. Assuming three procedures are conducted per list, lists consisting of joint replacements (82 dBA) or medium elective procedures (81 dBA) exceed this lower limit. Additionally, lists comprising large and medium bone fractures would be within 1 dB of the limit (79 dBA and 79 dBA, respectively). Soft tissue (74 dBA), arthroscopic (73 dBA), and small bone fracture (71 dBA) procedures had the lowest LEP, d. The greatest contributors to noise levels were surgical instruments. The number of people in the room made a significant difference to noise levels (p = 0.032). We have established the baseline noise levels in various orthopaedic procedures. Measures should be taken to meet UK regulations. Further research should determine suitable measures for protection from hearing damage for theatre staff and evaluate the risks high noise levels pose to patients.

Gamete Donation and Changing Anonymity in Third-Party Reproduction: UK Regulations

Gamete Donation and Changing Anonymity in Third-Party Reproduction: UK Regulations

A bloody mess? UK regulation of menopause discrimination and the need for reform

AbstractThis article considers the regulation of menopause‐related discrimination in the workplace. Many menopausal women experience profound workplace inequalities, often connected with the intersection of ageism and sexism. The United Kingdom Parliament's Women and Equalities Committee (WEC) recently recommended that the government consult about a new protected characteristic, ‘menopause’, and that Section 14 of the Equality Act 2010 (EqA) on dual discrimination be brought into force. The government has rejected these recommendations, asserting that menopausal women are sufficiently protected under the EqA's existing provision. This article presents an alternative perspective, arguing that there is insufficient legal protection from menopause discrimination, with it fitting poorly within age, sex, and/or disability discrimination, and there being no facility for intersectional claims. The WEC is correct: Section 14 should be implemented, ‘menopause’ should be a protected characteristic, and, beyond that, the EqA needs wider reform to provide greater protections from discrimination, beyond inflexible identity categories that fail to allow for complex intersecting structural oppressions.

Older LGBTQ People and Religious Abuse: Implications for the UK Regulation of Care Provision in Later Life

Research suggests health, social care, and social work professionals who are highly religious, and adhere closely to traditional doctrine, are more likely to take a negative view of LGBTQ people. This includes those who provide services to older people. Negative attitudes towards lesbian, gay, bisexual, trans and/or queer (LGBTQ) people can translate into poor care and even abuse. This commentary discusses recent literature on older LGBTQ people’s experiences of religious abuse. It highlights the concerns among many older LGBTQ people about care from religious based providers where religion becomes a factor leading to abuse, associated with microaggressions, psychological abuse, harassment, discriminatory abuse, neglect, and poor care. Even though only a minority of religious care providers may hold negative attitudes towards LGBTQ people, and even fewer may allow this to inform poor/abusive practice, this is nonetheless an area of concern and merits further investigation. All care providers, including those with strongly held religious beliefs, should deliver equally good, affirmative, non-abusive care to older LGBTQ people, and to LGBTQ people of all ages.<strong>Key words</strong>LGBTQ; religious care providers; abuse; adult protection; equality and human rights; law

Analysis of Donkis Global Strategy and the Factors Influencing Its Entry into the UK Market

This paper analyzes Donkis global strategy and the factors influencing its entry into the UK market. The paper follows a logical structure, starting with an introduction to Donkis global strategy and its success in Asia. A literature review is conducted to identify the factors influencing Donkis entry into the UK market, including research problems and objectives, market entry approach, and market-driving strategy for foreign markets. The paper then provides a case description of Donkis entry into the UK market, including an analysis of its expansion strategy and store design, as well as the challenges and opportunities for the company in the UK market. Problem analysis is conducted to identify the key challenges and opportunities for Donki in the UK market, including competitors, regulations, and supply chain. Finally, the paper provides recommendations for Donkis entry into the UK market, including a market entry approach, differentiation strategies, compliance and quality assurance, and optimized logistics. By adopting these recommendations, Donki can enhance its chances of success in the UK market and overcome the challenges identified in the problem analysis.

Navigating Parental Duties in a TikTok World, the UK and Nigeria Regulations and the Online Safety Bill

According to Ofcom, half of children used TikTok in 2021 and it is the third most used platform behind YouTube and WhatsApp. TikTok is a social media app with one billion monthly active users (Cervi et al., 2022; Dellatto, 2021). installed on devices, 3.5 billion times, available in 154 countries and accessible in thirty-nine languages. TikTok is offered to children of 13 years old (Independent Digital News and Media, 2022; Hoegh, 2022). TikTok was founded in 2018 with a mission to inspire creativity and bring joy (TikTok, 2023). However, its screentime consumption for children has experienced revolutionary change. One in five UK internet users are children according to the UK department for science Innovation and Technology, (2021) most of whom are on TikTok. Children are exposed to over one billion videos on TikTok every day This paper seeks to comparatively investigate the cultural differences, approaches, and challenges to parenting, responsible social media use by children in the United Kingdom and Nigeria (Attrill et al., 2016). To ascertain, whether the existing legal framework is sufficient in enforcing safeguarding measures required of TikTok and other social media platforms.

“It's a big added stress on top of being so ill”: The challenges facing people prescribed cannabis in the UK

BackgroundThis paper reports on the first qualitative study to interview people prescribed cannabis in the UK. Cannabis is a class B controlled substance under the 1971 Misuse of Drugs (MoD) Act, but a 2018 change to UK regulations provided for the prescription of cannabis for medical purposes. Relatively few people have been able to access a prescription, despite this policy change. This paper examines their experiences. MethodsQualitative, semi-structured interviews were conducted with 24 people with a prescription for cannabis, or their carers. Data was analysed using a reflextive thematic analysis approach. The findings are discussed using a zemiology (social harms) perspective which provides a language for critical reflection on the current cannabis policy context. ResultsAll participants reported that cannabis had significantly improved their mental and/or physical health, across a broad range of conditions. Many had been able to reduce their use of conventional medicines and reported that cannabis had relatively few side effects. Despite the potentially life-enhancing benefits of cannabis medicine, patients in the UK face multiple barriers to access. These include a lack of funding streams, bureaucratic supply problems, and a lack of training for doctors and police. Even for the few people able to obtain a prescription, the ongoing criminalisation of cannabis in the UK contributed to their experiences of stigmatisation. This often made it difficult and anxiety-inducing to take their medicine in public spaces. ConclusionThe UK government's lack of implementation of medical cannabis legalisation, combined with their ongoing prohibition position, is producing multiple harms to people who need cannabis medicine. The policy context is perpetuating stigmatising attitudes to cannabis which, as we demonstrate, contribute to social harms. We make recommendations on equality of patient access, and highlight the importance of education and policy change as means of combatting stigma.

Evaluation of hernia surgical meshes sterilised with ethylene oxide for adoption under UK regulations

BackgroundLow-cost meshes (LCM) have been successfully used in low-income countries (LIC) over the past decades, demonstrating comparable surgical outcomes to commercial meshes at a fraction of the cost. However, LIC sterilisation standards (autoclave sterilisation at 121 °C) do not meet UK regulations for medical devices, which require either ethylene oxide (EO) sterilisation or steam sterilisation at 134 °C. Therefore, the aim of this study was to sterilise UK LCM and characterise their mechanical properties and in vitro biocompatibility to verify whether EO sterilisation causes changes in the mechanical properties and biocompatibility of LCM.MethodsEO sterilised LCM were used. Uniaxial tensile tests were performed to measure mechanical properties. Biocompatibility was measured through viability and morphology of Human Dermal Fibroblasts (HDFs) cultured in mesh-conditioned media, and by calculating the metabolic activity and proliferation of HDFs attached on the meshes, with alamarBlue assay.ResultsBreak stress of LCM1 was significantly higher than LCM2 (p < 0.0001), while Young’s modulus of LCM1 was significantly lower than LCM2 (p < 0.05) and there was no significant difference in break strain. Viability and morphology showed no significant difference between LCM and control. Attachment and proliferation of HDFs on LCM showed a better proliferation on LCM2 than LCM1, with values similar to the control at the final time point.ConclusionsWe demonstrated that EO sterilisation affects LCM mechanical properties, but they still have values closer to the native tissues than the commercially available ones. We also showed that in vitro biocompatibility of LCM2 is not affected by EO sterilisation, as HDFs attached and proliferated on the mesh, while EO affected attachment on LCM1. A more detailed cost analysis of the potential savings for healthcare systems around the world needs to be performed to strengthen the cost-effectiveness of this frugal innovation.

Which computable biomedical knowledge objects will be regulated? Results of a UK workshop discussing the regulation of knowledge libraries and software as a medical device.

To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom. A briefing paper was circulated to a multi-disciplinary group of 25 including regulators, lawyers and others with insights into device regulation. A 1-day workshop was convened to discuss questions relating to our aim. A discussion paper was drafted by lead authors and circulated to other authors for their comments and contributions. This article reports on those deliberations and describes how UK device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While our focus is the likely approach of UK regulators, our analogies and analysis will also be relevant to the approaches taken by regulators elsewhere. We include a table examining the implications for each of the four knowledge levels described by Boxwala in 2011 and propose an additional level. If a knowledge object is described as directly executable for a medical purpose to provide decision support, it will generally be in scope of UK regulation as "software as a medical device." However, if the knowledge object consists of an algorithm, a ruleset, pseudocode or some other representation that is not directly executable and whose developers make no claim that it can be used for a medical purpose, it is not likely to be subject to regulation. We expect similar reasoning to be applied by regulators in other countries.

How are milk substitutes labelled in the UK? Should the term ‘milk’ be added to milk substitute labelling?

Abstract Existing regulation in the UK states that the term ‘milk’ can only be used in labelling to describe products that originate from animals. We conducted an observational study, which surveyed the availability and labelling of milk substitutes in UK supermarkets, and an online experimental study, which assessed the impact of using the term ‘milk’ on milk substitute labelling. In the experimental study, 352 UK adults were randomised to one of the two conditions where they saw milk substitutes that were either labelled with UK regulations (e.g., soya drink) or using the term ‘milk’ (e.g., soya milk). Our primary aims were to assess whether adding the term ‘milk’ to labels would (1) more accurately communicate the uses of milk substitutes or (2) confuse consumers about which products come from an animal source. In our observational study, milk substitutes were readily available and labelling varied significantly. In our experimental study, labelling products with the term ‘milk’ increased understanding of the product's use. However, participants who saw the term ‘milk’ on milk substitute labelling misidentified more milk substitutes as coming from an animal source. Future policy should consider the clarification of such labelling.

"The algorithm will screw you": Blame, social actors and the 2020 A Level results algorithm on Twitter.

In August 2020, the UK government and regulation body Ofqual replaced school examinations with automatically computed A Level grades in England and Wales. This algorithm factored in school attainment in each subject over the previous three years. Government officials initially stated that the algorithm was used to combat grade inflation. After public outcry, teacher assessment grades used instead. Views concerning who was to blame for this scandal were expressed on the social media website Twitter. While previous work used NLP-based opinion mining computational linguistic tools to analyse this discourse, shortcomings included accuracy issues, difficulties in interpretation and limited conclusions on who authors blamed. Thus, we chose to complement this research by analysing 18,239 tweets relating to the A Level algorithm using Corpus Linguistics (CL) and Critical Discourse Analysis (CDA), underpinned by social actor representation. We examined how blame was attributed to different entities who were presented as social actors or having social agency. Through analysing transitivity in this discourse, we found the algorithm itself, the UK government and Ofqual were all implicated as potentially responsible as social actors through active agency, agency metaphor possession and instances of passive constructions. According to our results, students were found to have limited blame through the same analysis. We discuss how this builds upon existing research where the algorithm is implicated and how such a wide range of constructions obscure blame. Methodologically, we demonstrated that CL and CDA complement existing NLP-based computational linguistic tools in researching the 2020 A Level algorithm; however, there is further scope for how these approaches can be used in an iterative manner.

Governance responses to international agreements: The impact of the Kolpak ruling on cricket 1998-2021

ABSTRACT This article investigates the impacts of global legal rulings and political agreements on domestic sport, and charts the responses of national governing bodies to these changes. The article studies rulings and agreements that impacted on employment practices within professional sport. The impact of the 2003 Kolpak ruling and the 2000 Cotonou Agreement on the movement of sportspeople is analysed. Through the context of English county cricket, this article develops Appadurai’s conceptualisation of global flows, particularly ethnoscapes and finanscapes, to investigate how these international rulings and agreements particularly impacted South African migration into the UK. The responses of cricketing governing bodies in England and South Africa are analysed, and the response of the England and Wales Cricket Board (ECB) to ‘Brexit’ is also examined. Longitudinal data were collected on the migration of cricket players within English county cricket from 1998 to 2021 (n = 2,192), a period encompassing the duration of which the Kolpak ruling applied. Further data were collected regarding the financial situation of the England and Wales Cricket Board, Cricket South Africa and the domestic cricket teams. We find four distinct periods within the timeframe, influenced by international policy. Despite cricket governing bodies in the UK and South Africa setting mitigating regulations, the Kolpak ruling led South African cricketers of international standard to migrate to the UK. Ultimately, it required Brexit for cricket’s governing bodies to control the migration of sportspeople into the UK.

Thirst in heart failure: A scoping review.

The aim of this study was to summarise the overall picture of thirst-related research in patients with heart failure. We conducted a scoping review following the Arskey and O'Malley methodological framework along with the PAGER framework. PubMed, CINAHL, Web of Science, Embase, The Cochrane Library, Jonna Briggs Institute, ProQuest Database, Google Scholar, PsycINFO, PQDT, CNKI, Wan Fang, VIP and CBM. Additionally, grey literature including grey databases (Opengrey, OpenDoar, Openaire and BASEL Bielefeld Academic Search Engine), conferences or articles (Scopus and Microsoft Academic), graduate theses databases (eTHOS, DART Europe, Worldcat and EBSCO Open Dissertations) and government information media (UK guidance and regulations, USA government websites, EU Bookshop and UN official publications) were searched. The databases were searched from inception to 18 August 2022 for Articles written in English and Chinese. Two researchers independently screened articles based on inclusion and exclusion criteria, and a third researcher adjudicated disagreements. We retrieved 825 articles, of which 26 were included. Three themes were summarised from these articles: (a) the incidence of thirst in patients with heart failure; (b) the thirst-related factors in patients with heart failure; and (c) the intervention measures of thirst in patients with heart failure.

Cumulative effects of offshore renewables: From pragmatic policies to holistic marine spatial planning tools

To alleviate climate change consequences, the UK government is pioneering offshore renewable energy developments at an ever-increasing pace. The North Sea is a dynamic ecosystem with strong bottom-up/top-down natural and anthropogenic drivers facing rapid climate change impacts. To ensure the compatibility of such large-scale developments with nature conservation obligations, regulatory processes set out that all effects need to be evaluated through cumulative impact assessments (CIA). However, by excluding climate change impacts and bottom-up effects of renewable developments, the CIA lacks spatio-temporal baselines linking oceanic ecosystem indicators to population dynamics, leading to uncertain predictions at population levels. CIA is currently required in Europe under the Strategic Environmental Assessment and the Marine Strategy Framework Directive (MSFD), suggesting that these two policy areas should be more closely aligned. This study presents an overview of the current CIA policy framework, enabling an ecosystem-based approach linking lower ecosystem components to top-predator populations using the UK as a case study. At the UK level, CIA requirements mirror the EU ones under the Marine and Coastal Access Act, the UK Marine Policy Statement, and the UK National Policy Statement. Firstly, we show how CIA and MSFD requirements are integrated into the UK licensing and maritime planning frameworks. Secondly, we provide policy pathways embedding the MSFD as a baseline for CIAs with European and UK regulations. Thirdly, we propose a framework encompassing a shared monitoring effort, an ecosystem modelling approach connected with two existing online databases supported with funds from Contracts for Difference. This integrated approach will enable a holistic and pragmatic ecosystem-based framework for more accurate and rapid methods for producing CIAs for offshore renewable energy developments.

For all (Hu)mankind? The intersection of mental capacity, informed consent and contract law with U.K. space law

The UK Space Industry Act 2018 has now been supplemented with the new Space Industry Regulations. While examples of Space Tourism grace our screens and newsfeeds on an increasingly regular basis such as William Shatner’s recent voyage (Luscombe, 2021) the UK Regulations also pave the way for ‘human occupants’ (UK Space Industry Regulations, Regulation 2) to experience such a flight (UK Space Agency, 2020). A key part of the regulations pertaining to human occupants is that they must provide ‘informed consent’ before embarking on such a flight. If, as is likely to be the case, future courts are to draw analogies with the current state of medical law in this area, spaceflight operators will have to tread carefully if they are to avoid vitiating any informed consent by ‘bombarding’ any willing human occupant with technical detail prior to their flight (Simmonds, 2020). Whilst this could prove legally problematic for ‘capacitous’ individuals within the meaning of the Mental Capacity Act 2005, it is likely to be even more so for those who could be deemed, in some aspects of their cognitive ability, to lack capacity. UK Space Legislation as it presently stands faces three problems: 1) There is presently no legal mechanism under UK Space Law to determine capacity. 2) As examples from the Court of Protection indicate, ‘capacity’ is a very nuanced legal concept and individuals who, on the fact of things, may appear to lack capacity as regards potentially risky activities, have been regarded by the Courts as, at least, partially capacitous in respect of certain decisions. Operators may find themselves having to tread a fine line to avoid claims of discrimination. 3) because of point 1) and the state of the Law of Contract as regards contractual relationships entered into by potentially incapacitous individuals, further significant legal problems may present themselves. This paper will focus primarily on the Law in England and Wales but some of the overarching conclusions will be of relevance to all UK jurisdictions.

The 19th FRAME Annual Lecture, November 2022: Safer Chemicals and Sustainable Innovation Will Be Achieved by Regulatory Use of Modern Safety Science, Not by More Animal Testing.

The decisions we make on chemical safety, for consumers, workers and the environment, must be based on the best scientific data and knowledge available. Rapid advances in biology, in cell-based technologies and assays, and in analytical and computational approaches, have led to new types of highly relevant scientific data being generated. Such data enable us to improve the safety decisions we make, whilst also enabling us to avoid animal testing. Stimulated by the UK and EU bans on animal testing for cosmetics, Next Generation Risk Assessment (NGRA) approaches, which integrate various types of non-animal scientific data, have been established for assessing the safety of chemical ingredients used in cosmetics and other consumer products. In stark contrast, the chemicals regulations in Europe and other parts of the world have not kept pace with modern safety science and regulators are now mandating even more animal testing. Urgently closing this science-regulation gap is essential to upholding the EU's legislative requirement that any animal testing is a last resort. The ongoing revisions of UK and EU chemicals strategy and regulations provide an opportunity to fundamentally change the design and assessment paradigm needed to underpin safe and more sustainable innovation, through applying the best science and tools available rather than continuing to be anchored in animal tests dating back many decades. A range of initiatives have recently been launched in response to this urgent need, in the UK as well as in the EU.

Review and Comparison of US, EU, and UK Regulations on Cyber Risk/Security of the Current Blockchain Technologies - Viewpoint from 2023

Review and Comparison of US, EU, and UK Regulations on Cyber Risk/Security of the Current Blockchain Technologies - Viewpoint from 2023

CRIMINAL CARTEL OFFENCE IN THE UK 10 YEARS AFTER THE AMENDMENT. EFFECTIVE REFORM OR FURTHER IMPEDIMENT TO PROSECUTION?

The article describes the operation in practice of UK regulations that stipulate grounds of criminal liability for the cartel offence for which the court may impose prison sentences and/or fines under the Enterprise Act 2002. Particular attention is paid to assessing the changes to the description of this offence introduced by the Enterprise and Regulatory Reform Act 2013, which came into force on 1 April 2014. The first fundamental change to this description was to eliminate the element of “dishonesty” in the description of the cartel offence. That change was due to the difficulties involved in proving the “dishonest” nature of the actions of those alleged to have committed the act. Most of the subsequent proceedings involving cartel conspiracies, even when hard-core cartels were alleged, crashed against these problems. The second fundamental change was the introduction into the cartel offence regulation of three types of circumstances giving grounds for finding that an act does not constitute an offence and three possible “defences” against allegations of the cartel offence. The article assesses to what extent these new regulations are able to ensure in practice an effective fight against cartel offences and to what extent they constitute a further impediment to this task. The article also describes the director’s disqualification measure applied under the Company Directors Disqualification Act 1986.

Open banking: A bibliometric analysis-driven definition.

"Open banking," as a concept, was initially developed by a UK regulation to foster competition in banking through sharing client data (with their consent) amongst competitors. Today, it is regulated in several most relevant banking jurisdictions. Despite its growing relevance, consensus about the definition of open banking is lacking. This study examines 282 articles on open banking using bibliometric clustering techniques. Moreover, within the 282 articles and applying discourse analysis, we analyze 47 idiosyncratic definitions of open banking to test an integral framework that supports our proposed definition of the concept. Our study contributes to the literature by providing a generalized multidisciplinary definition of open banking. It identifies four main drivers behind the concept: business model change, client data sharing, incorporation of technological companies (fintechs and others), and regulation. These four elements, which should be considered in new regulations in the globalized banking sector, foresee open banking as a critical enabler of a new strategic dynamic in banking.

Evaluating land application of pulp and paper mill sludge: A review.

It is estimated that >400Mt of board and paper are produced globally per year, and that 4.3-40kg (dw) of sludge like material, pulp and paper mill sludge (PPMS), is generated for every tonne of product. PPMS are now more widely reused in agriculture as a soil amendment due to their high organic content of 40-50% by weight, perceived low toxicity and possible liming capabilities. Within this review article historic and recent literature on PPMS land spreading are combined with knowledge of European and UK regulation to explore the benefits, potential impacts and viability of land spreading PPMS. The review reveals that risks relating to potential N immobilisation in soils post-application can be readily mitigated, if desired, by coapplication of an N source, or even pre-treatment of sludge via composting. The benefits to crops have been demonstrated emphatically, while negative ecological impacts under typical field application rates have not been observed to date. The case is therefore strong for continued land application of the material as an environmentally responsible and sustainable use option. However, there are currently gaps in the literature regarding longer-term implications of PPMS applications in agriculture and in regards to the possible presence of emerging contaminants in some PPMS materials, both of which have been identified as areas that merit further research.