scholarly journals Animal Research beyond the Laboratory: Report from a Workshop on Places Other than Licensed Establishments (POLEs) in the UK

Animals ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. 1868
Author(s):  
Alexandra Palmer ◽  
Beth Greenhough ◽  
Pru Hobson-West ◽  
Reuben Message ◽  
James N. Aegerter ◽  
...  
Keyword(s):  
Best Practice ◽  
Primary Objective ◽  
Animal Research ◽  
Ethical Review ◽  
Limited Attention ◽  
Social Scientists ◽  
Laboratory Report ◽  
Eu Directive ◽  
Conducting Research ◽  
The Uk

Research involving animals that occurs outside the laboratory raises an array of unique challenges. With regard to UK legislation, however, it receives only limited attention in terms of official guidelines, support, and statistics, which are unsurprisingly orientated towards the laboratory environment in which the majority of animal research takes place. In September 2019, four social scientists from the Animal Research Nexus program gathered together a group of 13 experts to discuss nonlaboratory research under the Animals (Scientific Procedures) Act (A(SP)A) of 1986 (mirroring European Union (EU) Directive 2010/63/EU), which is the primary mechanism for regulating animal research in the UK. Such nonlaboratory research under the A(SP)A often occurs at Places Other than Licensed Establishments (POLEs). The primary objective of the workshop was to assemble a diverse group with experience across a variety of POLEs (e.g., wildlife field sites, farms, fisheries, veterinary clinics, zoos) to explore the practical, ethical, and regulatory challenges of conducting research at POLEs. While consensus was not sought, nor reached on every point of discussion, we collectively identified five key areas that we propose require further discussion and attention. These relate to: (1) support and training; (2) ethical review; (3) cultures of care, particularly in nonregulated research outside of the laboratory; (4) the setting of boundaries; and (5) statistics and transparency. The workshop generated robust discussion and thereby highlighted the value of focusing on the unique challenges posed by POLEs, and the need for further opportunities for exchanging experiences and sharing best practice relating to research projects outside of the laboratory in the UK and elsewhere.

scholarly journals The Ethical Impact of the UK Human Tissue Act for the Foods, Cosmetics, Toiletries and Detergents Industries

2006 ◽  
Vol 2 (1) ◽  
pp. 10-14
Author(s):  
P. A. Carson ◽  
J. Holt ◽  
M. McGrady
Keyword(s):  
Human Tissue ◽  
Best Practice ◽  
Ethics Committees ◽  
Ethical Review ◽  
Healthy Human ◽  
Tissue Act ◽  
Human Tissue Act ◽  
The Uk ◽  
Relevant Material

The cosmetics, detergents and food industries trial development products using healthy human volunteer studies. They also use human tissue for in vitro investigations. Hitherto, the ethics of such work has not been regulated. The UK Human Tissue Act will have legal implications on current arrangements for such studies within the industry, especially with regards to informed consent and seeking ethical review of research proposals. At present, however, it is unclear who will fund ethical review for use of ‘relevant material’ in non-medical research, and on the required status of ethics committees to review such work. The principles behind the sampling, storage and processing of ‘relevant material’ are largely identical whether it be for medical or non-medical investigations. It is argued, therefore, that this is further justification for industry and professional bodies to adopt best practice of ethical review for all studies in ‘grey areas’ outside the scope of regulations. This would follow closely those standards applied to biomedical research.

scholarly journals Policing Research and the Rise of the ‘Evidence-Base’: Police Officer and Staff Understandings of Research, its Implementation and ‘What Works’

Sociology ◽  
2016 ◽  
Vol 52 (4) ◽  
pp. 813-829 ◽  
Author(s):  
Karen Lumsden ◽  
Jackie Goode
Keyword(s):  
Police Officers ◽  
Evidence Base ◽  
Evidence Based ◽  
Structured Interviews ◽  
Policy And Practice ◽  
Social Scientists ◽  
Conducting Research ◽  
The Uk ◽  
Organisational Factors ◽  
Evidence Based Policing

Despite the pitfalls identified in previous critiques of the evidence-based practice movement in education, health, medicine and social care, recent years have witnessed its spread to the realm of policing. This article considers the rise of evidence-based policy and practice as a dominant discourse in policing in the UK, and the implications this has for social scientists conducting research in this area, and for police officers and staff. Social scientists conducting research with police must consider organisational factors impacting upon police work, as well as the wider political agendas which constrain it – in this case, the ways in which the adoption of evidence-based policing and the related ‘gold standard’ used to evaluate research act as a ‘technology of power’ to shape the nature of policing/research. The discussion draws on semi-structured interviews conducted with police officers and staff from police forces in England.

scholarly journals Improving best practice for patients receiving hospital discharge letters: a realist review protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e018353 ◽  
Author(s):  
Katharine Weetman ◽  
Geoffrey Wong ◽  
Emma Scott ◽  
Stephanie Schnurr ◽  
Jeremy Dale
Keyword(s):  
Best Practice ◽  
Stakeholder Involvement ◽  
Realist Review ◽  
Ethical Review ◽  
Negative Effects ◽  
Programme Theory ◽  
Registration Number ◽  
Review Protocol ◽  
The Uk ◽  
Discharge Communication

IntroductionDischarge documents are important for transferring information from hospitals to the referring clinician; in the UK and many countries, this is often the patient’s general practitioner or family physician. However, patients may or may not receive their discharge letters, and whether patients should routinely receive discharge letters remains unclear.Methods and analysisThe review will consolidate evidence on patients receiving discharge letters through the theory-driven approach of a realist review.The review will be conducted systematically and seek to explain how, why, for whom and in what contexts does this practice ‘work’. The review will specifically explore whether therearebenefits of this practice and if so what are the important contexts for triggering the mechanisms associated with these outcome benefits. Negative effects will also be considered.Several steps will occur: devising initial rough programme theory, searching the evidence, selecting relevant documents, extracting data, synthesising and finally programme theory refinement. As the process is viewed as iterative, this cycle of steps may be repeated as many times as is necessary to reachtheoretical saturationand may not be linear.The initial programme theory will be tested and refined throughout the review process and by stakeholder involvement of National Health Service (NHS) policy makers, practitioners and service users.Ethics and disseminationFormal ethical review is not required. The resulting programme theory is anticipated to explain how the intervention of patients receiving written discharge communication may work in practice, for whom and in what contexts; this will inform best practice of patients receiving discharge communication. The review findings will be disseminated in a peer-reviewed journal and presentations and discussions with relevant organisations and stakeholders. While the review will be from the perspective of the UK NHS, its findings should be relevant to other healthcare systems.PROSPERO registration numberCRD42017069863.

Researching (with) Major Food Retailers

2015 ◽  
Vol 15 (3) ◽  
pp. 33-39 ◽  
Author(s):  
David Evans
Keyword(s):  
Food Systems ◽  
Academic Research ◽  
Social Scientists ◽  
Major Food ◽  
Food Retailers ◽  
Food Retailer ◽  
The One ◽  
The Uk ◽  
The Relationship ◽  
Opening Up

This paper considers the relationship between social science and the food industry, and it suggests that collaboration can be intellectually productive and morally rewarding. It explores the middle ground that exists between paid consultancy models of collaboration on the one hand and a principled stance of nonengagement on the other. Drawing on recent experiences of researching with a major food retailer in the UK, I discuss the ways in which collaborating with retailers can open up opportunities for accessing data that might not otherwise be available to social scientists. Additionally, I put forward the argument that researchers with an interest in the sustainability—ecological or otherwise—of food systems, especially those of a critical persuasion, ought to be empirically engaging with food businesses. I suggest that this is important in terms of generating better understandings of the objectionable arrangements that they seek to critique, and in terms of opening up conduits through which to affect positive changes. Cutting across these points is the claim that while resistance to commercial engagement might be misguided, it is nevertheless important to acknowledge the power-geometries of collaboration and to find ways of leveling and/or leveraging them. To conclude, I suggest that universities have an important institutional role to play in defining the terms of engagement as well as maintaining the boundaries between scholarship and consultancy—a line that can otherwise become quite fuzzy when the worlds of commerce and academic research collide.

The Ethics of AI in Biomedical Research, Patient Care, and Public Health

2020 ◽  
pp. 702-718 ◽  
Author(s):  
Alessandro Blasimme ◽  
Effy Vayena
Keyword(s):  
Public Health ◽  
Patient Care ◽  
Biomedical Research ◽  
Disease Surveillance ◽  
Ethical Issues ◽  
Ethical Review ◽  
Ethical Challenges ◽  
Healthcare Provision ◽  
Social Scientists ◽  
Ethical Frameworks

This chapter explores ethical issues raised by the use of artificial intelligence (AI) in the domain of biomedical research, healthcare provision, and public health. The litany of ethical challenges that AI in medicine raises cannot be addressed sufficiently by current regulatory and ethical frameworks. The chapter then advances the systemic oversight approach as a governance blueprint, which is based on six principles offering guidance as to the desirable features of oversight structures and processes in the domain of data-intense biomedicine: adaptivity, flexibility, inclusiveness, reflexivity, responsiveness, and monitoring (AFIRRM). In the research domain, ethical review committees will have to incorporate reflexive assessment of the scientific and social merits of AI-driven research and, as a consequence, will have to open their ranks to new professional figures such as social scientists. In the domain of patient care, clinical validation is a crucial issue. Hospitals could equip themselves with “clinical AI oversight bodies” charged with the task of advising clinical administrators. Meanwhile, in the public health sphere, the new level of granularity enabled by AI in disease surveillance or health promotion will have to be negotiated at the level of targeted communities.

Best practice for chronic oedema in community settings: what can we learn?

2020 ◽  
Vol 25 (12) ◽  
pp. 610-614
Author(s):  
Garry Cooper-Stanton
Keyword(s):  
Service Provision ◽  
Best Practice ◽  
Evidence Base ◽  
Community Services ◽  
Guidance Document ◽  
Community Settings ◽  
Tissue Viability ◽  
Delivery Of Care ◽  
Specialist Nurses ◽  
The Uk

There are various opportunities and challenges in the delivery of care to those diagnosed with chronic oedema/lymphoedema. Service provision is not consistent within the UK, and non-specialist nurses and other health professionals may be called on to fill the gaps in this area. The latest best practice guidance on chronic oedema is directed at community services that care for people within their own homes in primary care. This guide was developed in order to increase awareness, knowledge and access to an evidence base. Those involved in its creation cross specialist fields (lymphoedema and tissue viability), resulting in the document covering a number of areas, including an explanation of chronic oedema, its assessment and management and the association between chronic oedema and wet legs. The document complements existing frameworks on the condition and its management and also increases the available tools within chronic oedema management in the community. The present article provides an overview of the guidance document and discusses its salient features.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

scholarly journals Assessing the Progression of Alzheimer’s Disease in Real-World Settings in Three European Countries

2021 ◽  
Vol 80 (2) ◽  
pp. 749-759
Author(s):  
Albert Lladó ◽  
Lutz Froelich ◽  
Rezaul K. Khandker ◽  
Montserrat Roset ◽  
Christopher M. Black ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Mixed Model ◽  
Primary Objective ◽  
Community Dwelling ◽  
Behavioral Changes ◽  
The Uk ◽  
State Examination ◽  
Study Inclusion

Background: There exists considerable variation in disease progression rates among patients with Alzheimer’s disease (AD). Objective: The primary objective of this observational study is to assess the progression of AD by characterizing cognitive, functional, and behavioral changes during the follow-up period between 6 and 24 months. Methods: A longitudinal prospective study with community-dwelling patients with an established clinical diagnosis of AD of mild to moderate severity was conducted in Germany, Spain and the UK. A sample of 616 patients from 69 sites was included. Results: Patients had a mean of 1.9 years (SD = 1.9) since AD diagnosis at study inclusion. Cognitive symptoms were reported to have first occurred a mean of 1.1 years (SD = 1.7) prior to AD diagnosis and 1.4 (SD = 1.8) years prior to AD treatment. Patients initially diagnosed with mild and moderate AD spent a median (95%CI) of 3.7 (2.8; 4.4) and 11.1 (6.1, ‘not reached’) years until progression to moderate and severe AD, respectively, according to the Mini-Mental State Examination (MMSE) scores. A mixed model developed for cognitive, functional, and neuropsychiatric scores, obtained from study patients at baseline and during follow-up period, showed progressive deterioration of AD patients over time. Conclusion: The study showed a deterioration of cognitive, functional, and neuropsychiatric functions during the follow-up period. Cognitive deterioration was slightly faster in patients with moderate AD compared to mild AD. The duration of moderate AD can be overestimated due to the use of retrospective data, lack of availability of MMSE scores in clinical charts and exclusion of patients at time of institutionalization.

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