Research Ethics Research Articles

PRECIOUS study (PREterm Caesarean/vaginal birth and IVH/OUtcomeS): does mode of birth reduce the risk of death or brain injury in very preterm babies? A cohort and emulated target trial protocol

IntroductionVery preterm babies are at risk of poor neurodevelopmental outcomes and death. Intraventricular haemorrhage (IVH) after birth is the most prevalent cause of this. Birth by caesarean section may protect...

Assessing the effect of anthocyanins through diet and supplementation on cognitive function in older adults at risk for dementia: protocol for a randomised controlled trial

IntroductionPromising evidence is emerging for the procognitive, anti-inflammatory and neuroprotective properties of dietary flavonoids, particularly anthocyanins that provide red, purple and blue plant pigments.Methods and analysisThe ‘Food for Thought’ study...

Linkage of Hospital and Community level records for Epidemiological Research: Experiences from Kagando Health and Demographic Surveillance System in Western Uganda

BackgroundLinkage of census data and hospital records is crucial in conducting epidemiological research to inform public health decisions. In this study, we share our experiences in linking community-level data collected through census with hospital records and highlight the challenges and opportunities from our engagements with stakeholders. MethodologyWe undertook engagements with Uganda Christian University Ethics Research Committee, Hospital Management, and Community Health Volunteers to set up a platform to integrate hospital and census records using key identifiers. Trained data clerks prospectively linked data during patients’ visits following the data protection guidelines. ResultsFrom a population of approximately 30,000 people, we managed to link 1000 records within three months. Lessons learnt and opportunities: It is possible to link data with a set of identifiers, not only relying on common identifiers, especially for communities where ownership of a national identity card or birth certificate is not universal. Building stakeholder partnerships is essential, and frequent meetings with the hospital staff, epidemiologists and data programmers helped to identify problems and solutions. ChallengesLack of local capacity at the health facilities to develop linkage platforms. However, after development they can efficiently run the program. Frequent changes in the versions of the electronic system were later resolved. RecommendationsThere is a need to conduct regular capacity building for stakeholders to help them understand the importance of data linkage. ConclusionPublic engagement is an ethical imperative that enhances the quality, credibility, and long-term impact of research by incorporating the perspectives of the communities being studied.

Navigating Indigenous Data Sovereignty: A Decolonizing Approach to Understanding Opioid Use Amongst First Nations in Manitoba

First Nations (FN) and Indigenous Peoples around the world face significant challenges in navigating the complexities of Western research systems, particularly in the context of data sovereignty and research about their people and communities; the same can be said for Western researchers navigating Indigenous research space. We examine the intersection of Western research and FN data to explore opioid use amongst FN in Manitoba and highlight the ethical imperative of utilizing decolonizing frameworks when working with Indigenous data. Indigenous researchers led a retrospective cohort study linking the Manitoba FN research file to population-level data held at the Manitoba Centre for Health Policy. We centred Indigenous voices, knowledge, protocols, and contextually informed interpretation and fostered meaningful partnerships with academic researchers to ensure we utilized robust statistical methods while prioritizing community-driven questions, needs, and aspirations. Study period from 2015 to 2019 and included all Manitobans eligible for Manitoba Health Services. We found downward trends in opioid-related use, dispensation, hospitalization, and mortality rates for both FN and all other Manitobans (AOM), but a significant gap was found between FN and AOM for most indicators. Indigenous governance, ownership, engagement, collaboration, reciprocity, and respect for cultural and intellectual property rights are key concepts in ethical research practices that prioritize Indigenous self-determination and data sovereignty. We underscore the transformative potential of Indigenous-led research and use of decolonizing frameworks in fostering community empowerment to address opioid use in First Nation communities. We upheld the rights of Indigenous peoples to govern their data and undertake their own research.

Establishing Priorities for Improving Data Collection and Measurement of Mental Health and Well-Being of Adolescents With Special Educational Needs Within Nonmainstream Schools: Protocol for a Delphi Study.

There are more than 1.5 million children and young people in England with special educational needs (SEN), with over 160,000 young people in the United Kingdom attending a special school or alternative provision (AP) setting. Young people with SEN have been found to be at risk for poorer mental health and well-being than non-SEN peers. However, there is a range of both school-related and research challenges associated with identifying difficulties in a timely manner. This Delphi study aims to determine a list of stakeholder priorities for improving school-based measurement of mental health and well-being among young people with SEN, at an aggregated level, within secondary special school or AP settings. A secondary objective is to inform the implementation of school-based well-being surveys, improve engagement in special schools or AP settings, and improve survey response rates among children and young people with SEN. A mixed methods Delphi study will be conducted, including a scoping review and preliminary focus groups with school staff members and researchers to establish key issues. This will be followed by a 2-round Delphi survey to determine a list of stakeholder priorities for improving the measurement of mental health and well-being at an aggregate level within special schools and AP settings. A final stakeholder workshop will be held to discuss the findings. A list of recommendations will be drafted as a report for special schools and AP settings. The study has received ethical approval from the University College London Research Ethics Committee. The stage 1 scoping review has commenced. Recruitment for focus groups will begin in Autumn 2024. The first round of the Delphi survey will commence in early 2025, and the second round of the Delphi survey in the spring of 2025. The final workshop will commence in mid-2025 with final results expected in late 2025. There is a need for clear recommendations for special schools and AP settings on priorities for improving the measurement of mental health and well-being problems among young people with SEN. There is also a need for recommendations to researchers implementing school-based well-being surveys, including the #BeeWell program, to enable them to improve their engagement in special schools and AP settings and ensure surveys are accessible. PRR1-10.2196/58610.

Enhancing General Aviation Safety: The Integration of Generative AI in Preflight Weather Planning

Artificial Intelligence (AI) permeates daily life and industries through enhanced machine learning, natural language processing, and computer vision. Generative AI, a significant advancement, mimics human-like text and makes data-driven decisions, particularly in generative AI applications. Exploring novel AI applications is crucial, such as using generative AI to aid General Aviation (GA) pilots in preflight weather planning, with the aim to enhance pilots’ awareness and reduce weather-related accidents. However, the rapid evolution of generative AI raises many concerns like volatility, security risks, and decision-making biases. Preflight weather planning is vital in aviation, with weather-related incidents comprising a significant portion of accidents. Despite advancements, GA pilots’ interpretation of weather information remains subpar. This paper examines how generative AI may have potential to assist GA pilots to perform preflight weather planning, while also addressing risks and suggesting ethical research directions.

Responsible innovation for disruptive science and technology: The role of public trust and social expectations

As the world increasingly faces intersecting and complex environmental, social, and economic challenges, there are rising demands on emerging science and technology to produce innovative and potentially disruptive solutions. However, these solutions may also introduce different problems, uncertainties, and risks. Responsible innovation (RI) offers a way to identify and mitigate the social and ethical risks associated with new science and technology developments while delivering socially desirable and responsible outcomes. But how does the public view RI? In this paper, we argue that those undertaking disruptive science and technology research need a better understanding of the drivers of public trust in the research and innovation sector, and broader societal expectations of what constitutes socially responsible outcomes arising from their work. Few studies have explored if and how RI, trust, and social expectations are interrelated in the eyes of the public. This research investigates public perceptions of RI relevant to the development of novel and potentially disruptive science and technology, and their relationships with two key social outcomes: (1) public trust in the research and innovation sector; and (2) public expectations that innovative and potentially disruptive research can deliver socially responsible outcomes. Through surveying 4080 Australians, this research identifies how these four elements of RI – (i) practices of scientists, (ii) institutional compliance with research ethics, (iii) risk management effectiveness, and (iv) governance arrangements – are associated with public trust and expectations of socially responsible outcomes. Our best fitting path model showed that these elements of RI explain a large proportion of variability in trust in scientists and research institutions undertaking disruptive science, and most of the variability in public expectations that such research can deliver socially responsible outcomes. Of the four elements of RI, practices of scientists are most important for explaining trust in the research and innovation sector, and risk management effectiveness is most important for expectations of socially responsible outcomes from disruptive science and technology.

Regulatory solutions to alleviate the risks of generative AI models in qualitative research

ABSTRACT Generative AI models, with their enhanced capacity for conversation, will soon find widespread applications in qualitative research, especially in the disciplines of social science and public policy. Although researchers guarantee the confidentiality of the data, the tools they use for data analysis are largely their choice and remain unregulated, raising serious ethical concerns. Prior research has established the potentially hazardous effects of such transformative architecture on research integrity and ethics; however, the interventions required to alleviate the risks that impact the 3Rs – Reviewers, Researchers, and Research Respondents – have not yet been studied. Initially, we analysed the potential risks associated with Large Language Models (such as GPTs) by examining scientific publications. We then had a ‘risk workshop’ with four qualitative researchers, followed by open-ended interviews with seven individuals from the 3 R impact groups to develop the various risk scenarios. We compare these risks to the AI-related policies of the European Union, Singapore, the United States, the United Kingdom and China to identify regulatory gaps. The research output illustrates potential regulatory interventions on a continuum, with nodality-based soft laws at one end and more extensive regulatory interventions (hard laws) at the other for various LLM applications in qualitative research.

CONTROL OF DENTINE HYPERSENSITIVITY WITH THE USE OF DESENSITIZING: Case report of a patient from the city of Mato Verde - MG

Dentin hypersensitivity is characterized by an exacerbated response to thermal, chemical, osmotic and tactile sensory stimuli in the area where the dentin is exposed, causing acute and short-lasting painful symptoms. This study aimed to report a clinical case of control of dentin hypersensitivity using desensitizers. A qualitative study with observational/descriptive objectives, carried out in the municipality of Mato Verde-MG at Faculdade Verde Norte (FAVENORTE).The study was approved by the Research Ethics Committee, with opinion no. 6,985,721. A 22-year-old female patient attended dental care at the FAVENORTE Dental Clinic, complaining of intense sensitivity in several teeth. A medical and dental history was collected during anamnesis, as well as information regarding routine and lifestyle. On clinical examination, gingival recession and root exposure were found in elements 14, 15, 16, 24, 25, 34, 35, 44, 45, without loss of tooth structure. In the occlusal assessment, no changes were observed. The patient reports brushing teeth more than four times a day and using excessive force when brushing. After evaluation, it was concluded that the main etiological factor of the injuries was caused by a mechanical factor. For treatment, a desensitizer based on potassium nitrate (neural action) with sodium fluoride (obliterating action), Desensibilize KF 2%, was used. In the treatment of dentin hypersensitivity in the case described, the use of desensitizer, oral hygiene instructions, associated with maintenance with the use of dentifrice, proved to be a satisfactory procedure, since at the end of the treatment, the degree of discomfort related to the hypersensitivity condition dentin previously reported by the patient, ceased to exist. Therefore, the use of desensitizing agents is a low-cost procedure with excellent results.

Study protocol of a proposed Neurofeedback-Assisted Mindfulness Training Program on symptoms of anxiety and psychological distress associated with smartphone use in young adults: a randomized controlled trial.

Nomophobia is a specific phobia characterized by the appearance of anxiety, nervousness, discomfort and distress when the mobile phone is not used and is considered an emerging public health problem because of the negative consequences on the physical and mental health of young people and adolescents, especially women. Neurofeedback-Assisted Mindfulness Training Programs may prove beneficials for improving self-control abilities, a key ability in addressing addictive behaviors. The main objective of this study is to evaluate the impact, in a young population aged 18-35 years, of an intervention based on Neurofeedback-Assisted Mindfulness Training Program (NAMTP) on disorders associated with problematic use of mobile phones. The effect of the intervention on the total score in the nomophobia test and habits of internet and social network use, as well as on signs of depression, anxiety and stress will be analyzed. As a secondary objective, the effect of the intervention on signs of insomnia will be analyzed. Randomized, controlled clinical-trial with two-parallel groups. 40 young adults (18-35 years) will be included and randomly assigned to Intervention Group-NAMTP or Control Group (CG). The NAMTP will include a total of 25 sessions (2-3/week) during 3-months. Each session will have a duration of 10/15 min. The instrument to be used for the neurofeedback sessions is MUSE® (InteraXon Inc.). Study variables will be collected at the baseline visit and at the final visit (3-months after randomization). During these visits, questionnaires will be administered to evaluate the main and secondary variables that will include the Smartphone Addiction Scale-Short Version, Nomophobia Questionnaire, Depression, Anxiety and Stress Scale 21-item (DASS-21) and Athens Insomnia Scale. This trial will make an important contribution to the need for evidence of effective education programs and other primary care interventions through new non-invasive interventions in reducing the risk of developing addictions to new technologies and alleviating the symptoms of discomfort associated with this problem. The project was approved by the Clinical Research Ethics Committee of the Salamanca Health Area (CEIm Code: PI 2023 071340). ClinicalTrials.gov, http://www.Clinicaltrials.gov/ct2/show/NCT06188910.

Anxiety, depression, and suicide risk among health workers during the COVID-19 pandemic

Objective: To evaluate the relationship between symptoms of anxiety, depression and risk of suicide in hospital health workers during the COVID-19 pandemic. Methods: This is a quantitative, cross-sectional, web survey-type study carried out with 270 health workers from a university hospital in September 2022, using an electronic form, in which the Hospital Anxiety and Depression Scale and questions of the Self-Reporting Questionnaire were used. Data were analyzed using SPSS Software, version 26. Described and inferential statistics were performed. The study was approved by the Research Ethics Committee, through Opinion number 5,625,667. Results: There was a prevalence of 40% for anxiety symptoms and 33% for depressive symptoms in female nursing professionals and that professionals who reported "ideas of ending life" increased the chances of presenting symptoms of anxiety and depression by 17,620 and 12,362 times, respectively. Conclusion: The findings of this study add to those already existing in the literature that highlights the need for investments in strategies to welcome and protect the health of healthcare personnel.

Home-based EXercise and motivAtional programme before and after Liver Transplantation (EXALT): study protocol for phase II two-centre, randomised controlled trial

IntroductionPhysical frailty is associated with increased mortality and poor quality of life (QoL) before and after liver transplantation (LT). Evidence is lacking on how to tailor exercise and behavioural techniques...

Comparison of Instructions to Authors and Reporting of Ethics Components in Selected African Biomedical Journals: 2008 and 2017.

Journal editors instruct authors to describe human participant protections in original research reports. However, little is known about African biomedical journal authors' adherence to such journal editors' instructions. This study investigated changes in editors' instructions to authors and authors' reporting of research ethics information in selected African biomedical journals between 2008 and 2017. Twelve selected journal websites and online articles were reviewed in Eastern, Southern, and Western African [ESWA] countries. A pre-tested schema and a checklist were used to collect data from journal websites and articles published in 2008 and 2017, and the data were analysed using descriptive and inferential statistics. Half of the journals requested prospective authors to disclose ethics approval and related issues in their manuscripts between 2008 and 2017. There was a significant increase in instructions to authors regarding information on the protection of research participants within this period; more authors complied with these requirements in 2017 than in 2007.

“What if the patient has a severe reaction, and it is my fault?” A qualitative study exploring factors for sustainable implementation of penicillin allergy delabelling

BackgroundPenicillin allergy delabelling (PAD), the process of evaluating penicillin allergy labels, is a key target in antibiotic stewardship, but uptake of the procedure outside clinical studies is limited. We aimed to explore factors that need to be addressed to sustainably implement a clinical pathway for PAD.MethodsWe conducted a qualitative study based on semi-structured interviews with focus groups consisting of a purposive sample of twenty-five nurses and physicians working in four different hospitals in Western Norway. Systematic text condensation was applied for analysis.ResultsPsychological safety was reported as crucial for clinicians to perform PAD. A narrative of uncertainty and anticipated negative outcomes were negatively associated with PAD performance. Education, guidelines, and colleague- and leadership support could together create psychological safety and empower health personnel to perform PAD. Key factors for sustainable implementation of PAD were facilitating the informant’s profound motivation for providing optimal health care and for reducing antimicrobial resistance. Informants were motivated by the prospect of a simplified PAD procedure. We identified three main needs for implementation of PAD: (1) creating psychological safety; (2) utilising clinicians’ inherent motivation and (3) optimal organisational structures.ConclusionA planned implementation of PAD must acknowledge clinicians’ need for psychological safety and aid reassurance through training, leadership, and guidelines. To implement PAD as an everyday practice it must be minimally disruptive and provide a contextually adaptive logistic chain. Also, the clinician’s motivation for providing the best possible healthcare should be utilised to aid implementation. The results of this study will aid sustainable implementation of PAD in Norway.EthicsThe study was approved by the Western Norway Regional Committee for Medical Research Ethics (Study No:199210).

Clinical and Prognostic Characteristics in Childhood Osteosarcoma: A Single-Center Experience in Türkiye.

In our study, we aimed to share the clinical experiences of our center regarding osteosarcoma cases, the most common primary malignant bone tumor in children and adolescents. With approval from the Clinical Research Ethics Committee of our center, the data of 59 pediatric patients who were followed up in our center with the diagnosis of osteosarcoma between 2007 and 2021 were evaluated retrospectively. The mean time between the onset of symptoms and diagnosis was 3 months. Although not statistically significant, patients with a diagnostic delay of 3 months or less had a higher rate of recurrence and mortality. 59.3% of patients had metastatic disease, and the presence of metastases was associated with higher rates of recurrence and mortality. Significant number of patients had multiple surgical operations. Amputation as the first operation and the need for multiple surgeries were associated with higher mortality. Pathologically poor response to chemotherapy is associated with mortality. 42.4% of patients died, and the 5-year overall and disease-free survival rates were 47.5% and 30.5%, respectively. Survival rates were highest in non-metastatic and non-relapsed patients, and lowest in metastatic patients and patients with poor response to chemotherapy. Renal problems and cardiotoxicity were most frequently treatment-related complications. Significant improvements have been achieved in the survival and quality of life in osteosarcoma cases compared to previous years; however, there is still a long way to go, and more multicenter and multidisciplinary studies are needed on osteosarcoma.

Translational Bioethics in China: Brain-Computer Interface Research as a Case Study.

The research and development of emerging technologies has potential long-term and societal impacts that pose governance challenges. This essay summarizes the development of research ethics in China over the past few decades, as well as the measures taken by the Chinese government to build its ethical governance system of science and technology after the occurrence of the CRISPR-babies incident. The essay then elaborates on the current problems of this system through the case study of ethical governance of brain-computer interface research, and explores how the transition from research ethics to translational bioethics, which encourages interdisciplinary collaboration and focuses on societal implications, may respond to the challenges of ethical governance of science and technology.

Polymedia Literacy and Other Ethical Considerations for Online Ethnographic Research on Social Networking Sites.

Drawing on the authors' own ethnographic research, this article discusses the importance of developing polymedia literacy as a key step toward ethical online research on social networking sites (SNS). Polymedia literacy entails the ability to critically analyze the vast landscape of SNS, their affordances, and users' social motivations for choosing specific SNS for their interactions. Internet researchers face several ethical challenges, including issues of informed consent, "public" and "private" online spaces, and data protection. Even when research ethics committees waive the need for a formal ethics approval process, researchers of online spaces need to ensure that their studies are conducted and presented in an ethical and responsible manner. This is particularly important in research contexts that pertain to vulnerable populations in online communities.

Nomophobia in Nursing Staff and Interns at a Second Level Medical Care Hospital in Mexico

Introduction: mobile phones and tablets have become an essential tool in life. Excessive and prolonged use generates Nomophobia, characterized by the irrational fear of losing contact with the mobile phone. Objective: to determine Nomophobia in Nursing Staff and Interns at a Second Level Medical Care Hospital in Sinaloa, Mexico. Methods: descriptive, cross-sectional study. Sample of 330 participants. Probabilistic sampling. A personal data sheet and a Nomophobia questionnaire (NMPQ-20) were used. Descriptive and inferential statistics were employed. Approval was obtained from the Local Committee on Ethics and Health Research. Results: average age 33,82 years, 53,3 % were women, average seniority 7,54 years, 43,9 % belonged to the morning shift, general nurses predominated with 39,4 % and WhatsApp with 63 %. 38,5 % communicated frequently with their partner, 100 % used the mobile phone during the day and the average number of hours they used the device was 2,71 hours. Low levels of nomophobia (general and by dimensions) were obtained. No significant relationship or difference was found between nomophobia and age, seniority and work shift. Significant differences were found between nomophobia and sex and job category, where men and nursing interns predominated. Conclusions: nomophobia was found to be at low levels in nursing staff and interns. Significant differences were found between nomophobia and gender and category. It is essential to implement strategies that reduce the use of mobile devices, since it can put patient safety at risk by acting as a distraction.

P093 PLASMA PROTEINS PROFILE AND THERAPEUTIC RESPONSIVENESS IN PATIENTS WITH PREECLAMPSIA

Preeclampsia (PE) is a hypertensive syndrome of pregnancy, characterized by target organ damage, related to a high incidence of cardiovascular sequelae. PE requires antihypertensive drug therapy, however, about 40% of patients do not respond to this treatment, leading to worse clinical outcomes. Through the proteomic strategy, we 1) compared the profile of circulating proteins expressed in 10 responsive (R-PE) and 10 non-responsive to antihypertensive therapy (NR-PE), besides 10 healthy pregnant (HP); 2) investigated which proteins are differentially expressed between the groups and 3) found out which signaling pathways are altered between them. The study followed the Declaration of Helsinki and was approved by the Research Ethics Committee of the Ribeirao Preto Medical School, University of Sao Paulo (FMRP-USP, protocol code CAAE-37738620.0.0000.5440). We performed plasma protein quantification using mass spectrometry, the obtained data underwent bioinformatics analyses based on Uniprot, PatternLab for Proteomics, String and MetaboAnalyst softwares. Considering a fold change of 1.5, three proteins showed as significantly differentially expressed between HP and R-PE, one downregulated (transtyretin) and two upregulated (apolipoprotein C1 and hemoglobin subunit beta). Between HP and NR-PE, there were six, two downregulated (clusterin and plasmin heavy chain A) and four upregulated (apolipoprotein A-IV; heparin cofactor II; complement C4B and haptoglobin related protein). Between R-PE and NR-PE there were four, one downregulated (fibronectin) and three upregulated (pregnancy-specific beta-1-glycoprotein 1 (PSG1); complement C4B (C4B) and complement C4A (C4A). Regarding PE, C4A and C4B intensity peaks were correlated with blood pressure and creatinine levels. Both, together with PSG1, showed significant correlations with the newborn's weight and gestational week (all p< 0.05). These findings help to understand the pathophysiological mechanisms between the two subgroups of the disease, since the under regulated circulating proteins act in the blood pressure modulation and the upregulated may occur as compensatory mechanisms due to an inflammatory scenario. These data give insights to explain the complexity and clinical consequences of this disorder.

Dynamic Interplay of Online Risk and Resilience in Adolescence (DIORA): a protocol for a 12-month prospective observational study testing the associations among digital activity, affective and cognitive reactions and depression symptoms in a community sample of UK adolescents

IntroductionThe impact of digital activity on adolescent mental health has been difficult to assess because of methodological limitations and a lack of strong theory. Dynamic Interplay of Online Risk and...