Government Approval Research Articles

Why are organisational approvals needed for low-risk staff studies in the UK? Procedures, barriers, and burdens.

Health care staff should be given the opportunity to participate in research, but recruiting clinicians via their employing organisation is not always straightforward or quick in the UK. Unlike many countries outside the UK, very low-risk survey, interview or focus group studies can be subject to some of the same governance approval procedures as interventional studies. An exemplar study carried out by the NIHR funded Palliative Care Research Partnership North West Coast is used to highlight the challenges still faced by researchers and health care organisations when setting up a low-risk staff study across multiple NHS and non-NHS sites. A study database was created and information was collected on the first point of contact with the clinical site, Health Research Authority (HRA) and local organisational approval times, time from trust or hospice agreement to the first survey participant recruited and overall site survey recruitment numbers. Descriptive statistics (median, range) were used to analyse these data. Across participating NHS trusts, it took a median of 147.5days (range 99-195) from initial contact with the local collaborator to recruitment of the first survey participant and hospice sites mirrored these lengthy timescales (median 142days, range 110-202). The lengthiest delays in the HRA approval process were the period between asking NHS trusts to assess whether they had capacity and capability to support the research and them granting local agreement. Local approval times varied between trusts and settings which may indicate organisations are applying national complex guidance differently. There is the potential for HRA processes to use more NHS resources than the research study itself when recruiting to a low-risk staff study across multiple organisations. There is a need to reduce unnecessary administrative burden and bureaucracy to give clinicians and research staff more opportunities to participate in research, and to free up NHS R&D departments, research nurses and clinicians to focus on more demanding and patient focused research studies. Hospices need standardised guidance on how to assess the risk of being involved in low-risk research without adopting the unnecessarily complex systems that are currently used within the NHS.

Economic perceptions and government approval in Chile: An analysis of democratic transition (1990–2022)

Economic perceptions and government approval in Chile: An analysis of democratic transition (1990–2022)

Barriers and hurdles delaying governance approval for an ethically approved nationwide clinical trial in pancreatic cancer.

Streamlined, expedited clinical research is fundamental to rapidly test, translate and implement novel treatments into routine care to improve patient outcomes. The National Mutual Acceptance (NMA) scheme was designed to expedite the ethics approval process, however, growing concerns exist about the fragmented time-consuming governance process needed to actually commence clinical research in Australia. This study reports hurdles and barriers encountered while seeking governance approval for the SCANPatient trial. SCANPatient is a nationwide multi-centre trial comparing standard narrative radiological reporting of CT scans for suspected pancreatic ductal adenocarcinoma. with an alternative structured approach. SCANPatient was approved by a national Human Research Ethics Committee under the NMA. The documents, time, costs and platforms required to obtain governance approval and open the trial at 30 participating hospitals were analysed. Wide variation exists in research governance office (RGO) requirements for local approval, resulting in extra costs (>$117 000), delays of up to 4 months in commencing the trial at some participating sites, unplanned adjustment of the study design, and ultimately the loss of several potential sites. There were inconsistencies among RGOs minimum requirements and processes across jurisdictions and sites, with delays in obtaining approval signatures, time-consuming processes, differing platforms used to submit governance reviews and inflexibility of RGO processes all contributing to delays in progressing the trial and obtaining governance approval. The current governance process is time- and cost-consuming and undermines the NMA scheme's efforts to streamline the clinical trials review process.

Creating a learning health system to include environmental determinants of health: The GroundsWell experience.

Policies aiming to prevent ill health and reduce health inequalities need to consider the full complexity of health systems, including environmental determinants. A learning health system that incorporates environmental factors needs healthcare, social care and non-health data linkage at individual and small-area levels. Our objective was to establish privacy-preserving household record linkage for England to ensure person-level data remain secure and private when linked with data from households or the wider environment. A stakeholder workshop with participants from our regional health board, together with the regional data processor, and the national data provider. The workshop discussed the risks and benefits of household linkages. This group then co-designed actionable dataflows between national and local data controllers and processors. A process was defined whereby the Personal Demographics Service, which includes the addresses of all patients of the National Health Service (NHS) in England, was used to match patients to a home identifier, for the time they are recorded as living at that address. Discussions with NHS England resulted in secure and quality-assured data linkages and a plan to flow these pseudonymised data onwards into regional health boards. Methods were established, including the generation of matching algorithms, transfer processes and information governance approvals. Our collaboration accelerated the development of a new data governance application, facilitating future public health intervention evaluations. These activities have established a secure method for protecting the privacy of NHS patients in England, while allowing linkage of wider environmental data. This enables local health systems to learn from their data and improve health by optimizing non-health factors. Proportionate governance of health and linked non-health data is practical in England for incorporating key environmental factors into a learning health system.

Challenges and opportunities of translating animal research into human trials in Ethiopia

Background and objectivesAlthough the goal of translational research is to bring biomedical knowledge from the laboratory to clinical trial and therapeutic products for improving health, this goal has not been well achieved as often as desired because of many barriers documented in different countries. Therefore, the aim of this study was to investigate the challenges and opportunities of translating animal research into human trials in Ethiopia.MethodsA descriptive qualitative study, using in-depth interviews, was conducted in which preclinical and clinical trial researchers who have been involved in animal research or clinical trials as principal investigator were involved. Data were analyzed using inductive thematic process.ResultsSix themes were emerged for challenges: lack of financial and human capacity, inadequate infrastructure, operational obstacles and poor research governance, lack of collaboration, lack of reproducibility of results and prolonged ethical and regulatory approval processes. Furthermore, three themes were synthesized for opportunities: growing infrastructure and resources, improved human capacity and better administrative processes and initiatives for collaboration.Conclusion and recommendationsThe study found that the identified characteristics/features are of high importance either to hurdle or enable the practice of translating animal research into human trials. The study suggests that there should be adequate infrastructure and finance, human capacity building, good research governance, improved ethical and regulatory approval process, multidisciplinary collaboration, and incentives and recognition for researchers to overcome the identified challenges and allow translating of animal research into human trials to proceed more efficiently.

Involving patients and the public in research using linked confidential patient information without consent: a case study on the COloRECTal cancer data Repository (CORECT-R)

Objective and ApproachIn 2017, the charity Cancer Research UK funded a UK Colorectal Cancer Intelligence Hub to create the COloRECTal cancer data Repository (CORECT-R). This was intended to be a single research data system that links all datasets across the UK relevant to colorectal cancer and makes them available for research. As the four home nations (i.e. England, Scotland, Wales and Northern Ireland) have distinct data governance policies, data access and linkage has proven challenging. It has not yet been possible to create a UK-wide resource, hence limiting the potential of the data available. To address this, the Hub has recently sought to gain new governance approvals to link data from the four home nations. As part of this process, we aimed to investigate public acceptability of using confidential patient information (CPI) without consent in CORECT-R. ResultsSeventy-five participants from a diverse background attended one of four online consultation sessions. Participants raised a number of issues and concerns, including ensuring transparency in the access and use of CPI by academic and commercial partners, and being well-informed of how to opt-out. With open communication and explanation of our approach, participants gave almost unanimous support on the intended CPI use. ImplicationsInnovation and collaboration between researchers, data custodians and the public are essential to drive responsible and meaningful uses of population data. We showed an exemplar of embedding patient and public involvement in designing data linkage research. Key areas identified from the sessions will form the basis of future consultations.

De las políticas de mano dura a la política del estado de excepción en El Salvador

This article analyzes the process of deterioration of democracy in El Salvador, in the context of the exceptional regime imposed by the government of Nayib Bukele. Paradoxically, this is one of the governments in the post-conflict period with the highest level of citizen approval, according to public opinion polls (IUDOP, 2023). The study is based on historiographic research that analyzes the main impacts of the failure of the security policies of the ARENA and FMLN governments on democratic institutionality, combined with the statistical analysis of a national survey on the level of approval or rejection of the Bukele government and its security strategy, materialized in the emergency regime. It shows that the confluence of the unsatisfied security demands of the citizenry in the face of the problem of violence and the failure of the political opportunism of the ARENA and FMLN governments in security matters have contributed to the imposition of the exception regime by the government of Nayib Bukele, whose reduction in the homicide rate and victimization have generated a majority favorable opinion among the citizenry. This despite the risks posed by the authoritarian drift of the current regime and the restriction of certain democratic attributes in the relationship between the State and society. In summary, this research invites us to think about the complex connection between authoritarian populism, political culture and democracy. ECA Estudios Centroamericanos, Vol. 79, No. 774, 2024: 13-46.

Global economic influence and domestic regime support: evidence from China

Rising powers typically seek to play a larger role in international economic affairs, but we know little about the impact of this overseas expansion on domestic publics. This paper examines the domestic political consequences of rising states’ efforts to increase their foreign economic influence. We argue that public approval for these governments depends on whether they succeed or fail to expand their country’s global economic influence. To test this argument, we fielded three survey experiments in China, each focusing on a different component of China’s foreign economic strategy. In all three experiments, informing individuals that China has failed in increasing its role in the global economy reduced average levels of government satisfaction. Our evidence suggests that this drop in government approval operates through a weakened sense of national pride, rather than other channels based on economic prospects.

Risk assessment for 3D printing in construction projects

Purpose The purpose of this study is to identify and assess new risks in construction projects that use 3D printing. Design/methodology/approach A mixed approach of both qualitative and quantitative methods was used. Literature review was conducted to extract 30 risks of 3D printing in construction. A survey was then developed to assess the probability and impact of these risks. In total, 37 respondents, who have experience and/or knowledge of 3D printing, completed the survey. The risk priority was calculated using a fuzzy logic approach. The main benefit of the proposed model is being able to use numerical and linguistic data in the risk assessment model. Findings The results show that the main risks, in terms of priority, are lack of codes and regulations for 3D printing in construction, delay in government approvals, shortage in labour skilled in 3D printed construction, lack of knowledge and information of 3D printed design concepts and changes in 3D construction codes and regulations. Originality/value This paper fills an identified gap in the literature related to 3D printing in construction and provides insights into the key risks affecting this disruptive technology.

Non-Genetic Healthcare Providers' Experiences and Perspectives with Rapid Genome-Wide Sequencing in Canadian Neonatal Intensive Care Units.

Rapid genome-wide sequencing (rGWS) continues to transform the care provided to infants with genetic conditions in neonatal intensive care units (NICUs). Previous research has demonstrated that rGWS has immense benefits on patient care; however, little is known about non-genetic healthcare providers' (HCPs) experiences and perspectives of working with rGWS and supporting families through the rGWS testing process in Canadian NICU facilities. To address this gap, we surveyed and conducted semi-structured interviews with non-genetic HCPs of diverse professions from NICUs in British Columbia. An interpretive description approach was used to analyze interview transcripts to identify patterns and variations in non-genetic HCPs' experiences and perceptions with rGWS. Participants had varying degrees of exposure to rGWS and levels of comfort with the testing process. Numerous barriers affecting the implementation of rGWS were identified, including low levels of comprehension of rGWS, longer turn-around times than expected, and having to apply for provincial government approval to access testing. Participants desired more education on rGWS, clear guidelines on the use of rGWS in NICUs, and resources for non-genetic HCPs and parents to support implementation. The results from this study can inform the development of workflows and educational resources on the use of rGWS in NICUs, helping to ensure that the NICU team is supported to optimize rGWS implementation.

Preventing adverse events during paediatric cancer treatment: protocol for a multi-site hybrid randomised controlled trial of catheter lock solutions (the CLOCK trial)

IntroductionCentral venous access devices (CVADs) are commonly used for the treatment of paediatric cancer patients. Catheter locking is a routine intervention that prevents CVAD-associated adverse events, such as infection, occlusion...

Ethics guidelines for palliative care of terminally ill patients in Islamic Republic of Iran.

There have been many challenges with clinical interventions and policy decisions to enhance the quality of life and care for patients facing life-threatening illnesses, thus highlighting the need for ethical considerations and guidelines for palliative care of terminally ill patients. To document the development of guidelines for addressing ethical concerns in the palliative care of terminally ill patients in Islamic Republic of Iran. The guidelines were developed in 4 phases: a scoping review of existing palliative care guidelines on PubMed, Scopus, Web of Science, Google Scholar, and 2 Persian databases; focus group discussions to improve the drafts guidelines; online opinion poll of 32 experts, including ethicists, religious scholars, psychologists, palliative care specialists, and sociologists; and a national workshop to produce the final guidelines for government approval. We published the "National palliative care ethical guidelines and regulations for terminally ill patients" in Islamic Republic of Iran after endorsement and approval by the High Council of Medical Ethics. The guidelines provides recommendations on 5 main aspects of palliative care: structure, composition and qualification of interdisciplinary teams; the roles and responsibilities of ethics advisors; general ethical principles governing palliative care practice; specific guidelines for psychological, spiritual and religious support; and protocols for ethical decision-making in end-of-life care. Considering the challenges associated with palliative care, it is necessary to provide ethical guidelines specific to the needs of terminally ill patients. These guidelines will serve as a steppingstone towards integrating palliative care into the national healthcare services in Islamic Republic of Iran.

Estonia: Political Developments and Data in 2023

AbstractParliamentary elections in March 2023 brought a stronger than ever mandate for the ruling Reform Party, which formed a new all‐liberal coalition with the Social Democratic Party and Estonia 200. However, the deteriorating public image of the Prime Minister and her party, the fact that Estonia 200 lost its new party image, and the political decisions made by the new government brought government approval and support drastically down by the end of the year. Struggling to tackle a growing budget deficit and to invigorate an economy in recession, it was a politically tough year for Estonia. And the fact that all viable coalitions until the next parliamentary elections in 2027 must include the Reform Party was likely to keep politics rigid, on the one hand, and tense on the other.

Representation in International Relations, Impeachment of the President of Georgia, and European Integration

Abstract The 2017–2018 constitutional reform amended the Constitution of Georgia and changed the political system of the country. The president has the responsibility to represent the country in international relations, but only with the approval of the government. Constitutional norms are not specific, leaving room for different interpretations. Article 78 of the Constitution obliges constitutional bodies to use all measures for European integration. Under this constitutional obligation, the president met with European colleagues, though without governmental approval. This provoked the ruling party to initiate the process of impeachment. The Constitutional Court of Georgia concluded that the president breached the Constitution, but the parliament could not impeach the president. The paper analyses the role of presidential representation in international relations and its constitutional responsibility in the light of Georgia’s European aspirations.

Genotype- and sex-specific changes in vital parameters during isoflurane anesthesia in a mouse model of Alzheimer's disease.

The prevalence of neurodegenerative diseases is increasing as is life expectancy with Alzheimer's disease accounting for two-thirds of dementia cases globally. Whether general anesthesia and surgery worsen cognitive decline is still a matter of debate and most likely depending on the interplay of various influencing factors. In order to account for this complexity, Alzheimer's disease animal models have been developed. The Tg2576 model of Alzheimer's disease is a well-established mouse model exhibiting amyloidopathy and age-dependent sex-specific differences in Alzheimer's disease symptomology. Yet, data on anesthesia in this mouse model is scarce and a systematic comparison of vital parameters during anesthesia with wild-type animals is missing. In order to investigate the safety of general anesthesia and changes in vital parameters during general anesthesia in Tg2576 mice, we did a secondary analysis of vital parameters collected during general anesthesia in aged Tg2576 mice. After governmental approval (General Administration of the Free State of Bavaria, file number: 55.2-1-54-2532-149-11) 60 mice at 10-12 months of age were exposed to isoflurane (1.6 Vol%) for 120 min, data of 58 mice was analyzed. During general anesthesia, heart rate, respiratory rate, temperature, isoflurane concentration and fraction of inspired oxygen were monitored and collected. Data were analyzed using univariate and multivariate linear mixed regression models. During general anesthesia, heart rate decreased in a sex-specific manner. Respiratory rate decreased and body temperature increased dependent on genotype. However, the changes were limited and all vital parameters stayed within physiological limits. Isoflurane anesthesia in the Tg2576 mouse model is safe and does not seem to influence experimental results by interacting with vital parameters. The present study provides information on appropriate anesthesia in order to advance research on anesthesia and AD and could contribute to improving laboratory animal welfare.

Electronic Submission in Construction: Government Approval Practice and Potential Issues in Malaysia

Post-COVID-19 has strongly impacted the construction industry worldwide; many parties took alternatives to facilitate the relatively overdue work arrangements. The Malaysian construction industry has been directly affected and has had to increase the adoption of One-Stop Centre (OSC) electronic submissions. According to the Malaysian online system submission policies, it is necessary to obtain construction approval from the OSC through the implementation by town councils. Not understanding the process and documents involved in this procedure might result in ineffective submissions. Hence, the study objectives are to identify: 1) The current submission process and documents for construction approval to town councils, and 2) Issues related to the e-submission process. Semi-structured interviews were conducted with individuals from twenty town (20) city councils in Malaysia to achieve those objectives. The results indicate that the general process includes submitting the required documents through the OSC, validation of submittals, and meeting approvals. The required documents include planning permissions, drawings, engineering plans, environmental management plans, landowner documents, and approvals by other government agencies. Finally, the issues with the e-submission include technical problems and the lack of experience of all involved stakeholders. These findings can be used by policymakers to improve the submission system and industry practitioners in acquiring construction approvals.

Analysing the Project Delay Causes and Improving Quality using Multi-Project Strategies

Numerous reasons for project delays from the viewpoints of the client and the contractor have only been somewhat studied. The aim of this paper is to recognize the delays' underlying causes and issues ways to reduce them considering the progress of the project. Consequently, 106 contractor-side experts and 82 client-side experts in project management were the subjects of this study. The clients and contractors gave the same importance to factors like poor communications and governmental approvals in projects that were successful (had a time delay of less than 10%). Similar mitigating techniques including rigorous project monitoring, skill development training, and effective logistics planning were advised. When projects were unsuccessful (with a time delay of more than 10%), they displayed a wide range of behaviours.

Can RESPiratory hospital Admissions in children with cerebral palsy be reduced? A feasibility randomised Controlled Trial pilot study protocol (RESP-ACT)

IntroductionThe most common cause of morbidity and mortality in children with severe cerebral palsy (CP) is respiratory disease. BREATHE-CP (Better REspiratory and Airway Treatment and HEalth in Cerebral Palsy) is...

Clinical trials and their impact on policy during COVID-19: a review.

Of over 8,000 recorded randomised trials addressing COVID-19, around 80% were of treatments, and 17% have reported results. Approximately 1% were adaptive or platform trials, with 25 having results available, across 29 journal articles and 10 preprint articles. We conducted an extensive literature review to address four questions about COVID-19 trials, particularly the role and impact of platform/adaptive trials and lessons learned. The key findings were: Q1. Social value in conducting trials and uptake into policy? COVID-19 drug treatments varied substantially and changed considerably, with drugs found effective in definitive clinical trials replacing unproven drugs. Dexamethasone has likely saved ½-2 million lives, and was cost effective across a range of countries and populations, whereas the cost effectiveness of remdesivir is uncertain. Published economic and health system impacts of COVID-19 treatments were infrequent. Q2. Issues with adaptive trial designs. Of the 77 platform trials registered, 6 major platform trials, with approximately 50 treatment arms, recruited ~135,000 participants with funding over $100 million. Q3. Models of good practice. Streamlined set-up processes such as flexible and fast-track funding, ethics, and governance approvals are vital. To facilitate recruitment, simple and streamlined research processes, and pre-existing research networks to coordinate trial planning, design, conduct and practice change are crucial to success. Q4. Potential conflicts to avoid? When treating patients through trials, balancing individual and collective rights and allocating scarce resources between healthcare and research are challenging. Tensions occur between commercial and non-commercial sectors, and academic and public health interests, such as publication and funding driven indicators and the public good. There is a need to (i) reduce small, repetitive, single centre trials, (ii) increase coordination to ensure robust research conducted for treatments, and (iii) a wider adoption of adaptive/platform trial designs to respond to fast-evolving evidence landscape.

Implementation of a nurse-led, multidisciplinary model of care for older adults with cancer: a process evaluation protocol

IntroductionCancer is predominantly a disease of older adults, with an increasing number of cancer diagnoses in individuals aged 65 or older. Multiple geriatric factors have been shown to impact patient...