Research Ethics Committee Research Articles

Agent regret and the moral responsibility for the misuse of research results

An increasing number of research fields must expect that their projects will be classified as susceptible to misuse or otherwise security relevant, even if the reasons or criteria for this classification have not yet been uniformly developed. Research institutions will commonly distribute the obligation to predict and prevent misuse across multiple members and structures including ethics committees. However, cases of misuse occur even in spite of these precautions, raising the question of the type and distribution of responsibility for the resulting harm. This question becomes even more pressing if research ethics committees in their decisions ask researchers to provide a misuse- specific risk assessment or risk mitigation plan and thereby shift back a part of their responsibility on the researchers. While this kind of requirement may be considered as unsatisfactory by researchers, members of research ethics committees or boards and third-party funders, will argue that it fulfils two important functions. On the one hand, it makes use of the best available source for misuse risk-assessment available to most committees; on the other hand, it guarantees that the researchers at least try to take responsibility. If researchers, committee members and others involved discharge their obligation to predict and mitigate misuse risks with due diligence, any backward-looking responsibility they retain is to show agent regret for the results of their work having been misused.

Knowledge, Attitudes, and Practices towards Single-Use Plastic Bags in the United Arab Emirates

Due to their widespread misuse and inadequate waste management, single-use plastic bags represent the global plastic pollution crisis and ecosystem degradation. Comprehensive research on population knowledge, attitudes, and practices (KAP) regarding single-use plastic bags is lacking in the United Arab Emirates (UAE). This study aims to fill this gap by assessing the KAP levels among the UAE population and determining the relationships between these variables. A five-point Likert scale questionnaire from previous studies was used in a cross-sectional study, and the questionnaire was distributed via Google Forms. The UAE University Research Ethics Committee approved the study (ERSC_2024_4377). Non-probability sampling and G*power statistical analysis version 3.1.9.6 determined 385 UAE residents aged 18 years and older. The findings were verified through face-to-face interviews and Cronbach’s alpha tests. KAP variable associations were assessed using Chi-square tests, Pearson’s correlation coefficients, and a structural equation model with SPSS version 29.0. This test was chosen for robust categorical and continuous data. The study included 84.7% female, and 15.3% male participants aged 18 to 65 years, primarily aged 18 to 25 years, with most holding bachelor’s degrees (47.6%), and were students (51.4%), employed (33.1%), or unemployed (12.2%). The results indicated a favourable inclination towards sustainability, with mean ± standard deviation (SD) for seven knowledge questions (3.89 ± 0.7), seven attitude questions (3.99 ± 0.7), and five practice questions (3.42 ± 0.8) exceeding the midpoint. The correlation test showed that total knowledge was positively correlated with practice (r = 0.399; p < 0.001) indicating the increasing knowledge regarding single-use plastic bags associated with increasing sustainable practices and attitudes (r = 0.648; p < 0.001). There was also a significant correlation between the total attitude and practice (r = 0.487; p < 0.001). The findings suggest targeted educational and policy interventions to promote sustainable behaviour.

Pharmacotherapy profile for mothers with schizophrenia and bipolar affective disorder in a psychiatric mother–baby unit

AbstractBackgroundPharmacotherapy treatment is used to manage women with schizophrenia and bipolar affective disorder admitted to a mother–baby unit (MBU).AimThe aims of this study were (1) to examine prescribing practices for women with schizophrenia and bipolar affective disorder in an MBU, (2) to assess alignment with the Mental health care in the perinatal period: Australian clinical practice guideline and (3) to examine the classes of typical and atypical antipsychotics prescribed to mothers with schizophrenia.MethodA retrospective audit of women with schizophrenia and bipolar affective disorder admitted to a psychiatric MBU, located in Queensland, Australia, was conducted from March 2017–July 2019. The exclusion criteria included women admitted with depression, anxiety, personality disorders, and postpartum psychosis. Pharmacotherapy treatment details were extracted at commencement of admission, mid‐way through admission, and discharge. Descriptive statistics were completed. This project was exempt due to the local policy requirements that constitute research by the Gold Coast Hospital and Health Service Human Research Ethics Committee (Reference no: EX/2023/QGC/102306). The justification for this exemption was as follows: the study was deemed a quality improvement activity and complied with Chapter 2.3 of the National Statement of Ethical Conduct in Research and involved only routinely collected data.ResultsOf the 53 mothers included in the study, 29 (55%) had schizophrenia and 24 (45%) had bipolar affective disorder. In addition, 97% of women with schizophrenia received atypical antipsychotics. Five women (21%) with bipolar affective disorder (mean age = 31.60 years, standard deviation = 6.19 years) were prescribed sodium valproate, with four women given contraception. Sodium valproate or lamotrigine were prescribed to four women (67%) with bipolar affective disorder whilst breastfeeding. Of mothers prescribed lithium, 92% did not breastfeed. Overall, 44% of women involuntarily admitted received antipsychotic depot medication compared with 38% of voluntary patients. Results are discussed in relation to the national guidelines.ConclusionThis is the first naturalistic study to examine the pharmacotherapy management of postpartum women admitted to a psychiatric MBU with schizophrenia and bipolar affective disorder. The study highlights that prescribing patterns across three time points during admission were generally in alignment with Australian national guidelines.

Reducing refusals of care through improved personal care interactions between caregivers and people with dementia: protocol for a realist synthesis

IntroductionPeople with dementia develop progressive difficulties conducting basic activities of daily living, often requiring considerable assistance from caregivers. Many people with dementia, particularly in the advanced stages, can refuse assistance...

COMPARISON OF MALACHITE GREEN AND METHYLENE BLUE DYES IN NON-SURGICAL PERIODONTAL TREATMENT IN PATIENTS LIVING WITH HIV/AIDS AND UNDERGOING IMMUNE RECONSTITUTION

The aim of this study was to evaluate the effect of photodynamic therapy (PDT) on non-surgical periodontal treatment in patients failing highly active antiretroviral therapy (HAART). comparing methylene blue (MB) (0.01%) and malachite green (MG) (0.01%) dyes as a therapeutic protocol, measuring the following periodontal clinical parameters: clinical probing depth (CPD), gingival recession (GR), clinical attachment level (CAL), full-mouth plaque index (PI), and full-mouth bleeding index (BI), using polymerase chain reaction (PCR) for identification of Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), and Tannerella forsythia (Tf) pathogens. The study was approved by the Research Ethics Committee. Forty-four patients were evaluated, 15 (34.1%) female and 29 (65.9%) male. The mean age was 46 years. In the evaluation of GR, there was a significant difference in the non-resistant group in which MB was used. Resistant patients treated with MG or MB showed significant differences in the decrease of Pg bacteria. PDT associated with MB promoted improvements in CPD and decrease of Aa and Pg bacteria, being an effective therapeutic protocol.

Electroconvulsive Therapy Versus Aripiprazole Addition to Clozapine in Patients with Clozapine-Resistant Symptoms (EMECLO): A Protocol of a Single-Blind, Multicenter, Randomized-Controlled Feasibility Trial.

Currently, guidance on the most effective treatment for patients with clozapine-resistant schizophrenia-spectrum disorders (SSD) is lacking. While augmentation strategies to clozapine with aripiprazole and electroconvulsive therapy (ECT) have been demonstrated to be effective in patients with clozapine-resistant schizophrenia spectrum disorders (CRS), head-to-head comparisons between these addition strategies are unavailable. We therefore aim to examine the feasibility of a larger randomized, single-blind trial comparing the effectiveness, cost-effectiveness, and safety of aripiprazole addition vs. ECT addition in CRS. In this multi-center, randomized, single-blind feasibility study, the feasibility of recruiting 20 participants with CRS who will be randomized to either aripiprazole or bilateral ECT addition will be assessed. The main endpoint is the number of patients willing to be randomized. The number of screened individuals and reasons to decline participation will be recorded. Effects will be estimated for the benefit of the foreseen larger trial. To that end, differences between both arms in symptom severity will be assessed using blinded video assessments. In addition, tolerability (e. g., cognitive functioning), safety, quality of life, recovery, and all-cause discontinuation will be compared. The follow-up period is 16 weeks, after which non-responders will be given the option to switch to the other treatment. Strengths of this feasibility trial include maintaining blinding with video assessment, a possibility to switch groups in case of non-response, and a broad set of outcome measures. Identification of factors contributing to non-participation and drop-out will generate valuable information on trial feasibility and may enhance recruitment strategies in a follow-up RCT. The study has been approved by the Medical Research Ethics Committee of the Amsterdam University Medical Center, location AMC, and was registered on 1 May 2022 in the EU Clinical Trials Register (EudraCT) under the trial name 'EMECLO' (2021-006333-19).

Feasibility and potential effects of a dyadic coping intervention for patients with spinal cord injury and their spouses: a study protocol for a pilot randomised controlled trial

IntroductionIt remains difficult for patients with spinal cord injury (SCI) to fully recover their sensory and motor functions; thus, they must rely on the assistance of caregivers to complete activities...

Study protocol for the ROLEX-DUO randomised placebo-controlled trial: ROmosozumab Loaded with EXercise – DUal effects on bone and muscle in postmenopausal Osteoporosis and Osteopenia

IntroductionNovel strategies are needed to address the rising burden of osteoporosis and fragility fractures. High-intensity resistance and impact (HiRIT) exercise has shown benefit in improving bone density in postmenopausal women...

Scientific evidence available after 18 years of application of fibrin rich in platelets and leukocytes in the repair of surgical wounds: An integrative review

Introduction: In the last 18 years, Platelet and Leukocyte Rich Fibrin (L-PRF) has emerged as an innovative biomaterial in regenerative medicine and dentistry, standing out for its ability to continuously release growth factors and promote more efficient healing. However, the variability in the preparation and application of L-PRF, together with the lack of standardization, represent major challenges, increasing the need for further research to improve and standardize its clinical use. Materials and Methods: This study is an integrative review, with no need to submit it to the Research Ethics Committee. The guiding question was: “What is the main evidence in the literature on the applications of platelet- and leukocyte-rich fibrin in dentistry?”. Results and Discussion: L-PRF has proved effective in various areas of dentistry. In implantology, it accelerates bone healing and improves implant integration. In periodontics, it promotes regeneration of bone damage and improves the quality of periodontal tissue. In gingival recessions and soft tissue lesions, it accelerates regeneration and reduces post-operative discomfort. In periodontal and maxillofacial surgery, it contributes to a faster and more comfortable recovery from swelling and pain. Variability in the preparation and application of L-PRF is still a challenge, and standardization of protocols is essential to ensure more consistent and predictable results. Conclusion: After 18 years, L-PRF has shown beneficial effects in dentistry, especially in terms of bone regeneration and improved post-operative healing. However, the standardization of protocols seems to be crucial in order to improve its clinical results.

Effect of reiki on people with advanced cancer: a randomized controlled trial

Introduction: Reiki is an Integrative and Complementary Health Practice (PICS), recognized and incorporated into the table of procedures of Brazil's Unified Health System (SUS). Objective: To evaluate the effects of applying Reiki in relieving the symptoms of people with advanced cancer who are hospitalized. Methodology: Randomized controlled study, approved by the Research Ethics Committee, to verify the effect of applying Reiki to people with advanced cancer, admitted to a large, highly complex university hospital located in the interior of the state of São Paulo, Brazil. Fourteen participants were selected from the clinical oncology ward and randomly divided into two groups - Reiki and control - with seven participants each. For data collection, an anamnesis was taken, blood pressure and heart rate were measured, saliva was collected to check cortisol levels; the Edmonton Symptom Assessment System (ESAS), Hospital Anxiety and Depression Scale (HAD-S) and Karnofsky Performance Status (KPS) were applied; Reiki was applied for 21 minutes to participants in the Reiki group and, 30 minutes after Reiki, the scales were reapplied and salivary cortisol was collected again. Results: The Mann-Whitney U-test showed a statistically significant difference for the sleep variable (p<0.007) in the intervention group when compared to the control group. Conclusion: The results showed that Reiki improved the sleep of the participants in this randomized controlled trial and demonstrated that, despite the small caseload, the methodology used is valid for studying the impact of Reiki on the symptoms of people with advanced cancer.

Neuropsychological outcomes of patients with haematological malignancies undergoing chimeric antigen receptor T-cell therapy: protocol for a prospective study

IntroductionImmune effector cell-associated neurotoxicity syndrome (ICANS) is a common side-effect of chimeric antigen receptor T-cell (CAR-T) therapy, with symptoms ranging from mild to occasionally life-threatening. The neurological, cognitive, psychiatric and...

The lived experience of renal cachexia: An interpretive phenomenological analysis

BackgroundChronic kidney disease is common, affecting up to 13 % of the global population, and is predicted to become the fifth leading cause of 'life years lost' by 2040. Individuals with end-stage kidney disease commonly develop complications such as protein-energy wasting and cachexia which further worsens their prognosis. The syndrome of ‘renal cachexia’ is poorly understood, under-diagnosed and even if recognised has limited treatment options. ObjectiveTo explore the lived experience of renal cachexia for individuals with end-stage kidney disease and the interrelated experiences of their carers. DesignThis interpretive phenomenological study was designed to facilitate an in-depth exploration of how patients and carers experience of renal cachexia. To improve and document the quality, transparency, and consistency of patient and public involvement in this study the Guidance for Reporting Involvement of Patients and the Public-Short Format was followed. SettingThe study was conducted across two nephrology directorates, within two healthcare trusts in the United Kingdom. ParticipantsSeven participants who met the inclusion criteria were recruited for this study, four patients (three female, one male) and three carers (two male, one female). MethodsWe employed a purposive sampling strategy. Data collection was conducted between July 2022 and December 2023. Interviews were semi-structured, audio-recorded, transcribed verbatim and analysed in six steps by two researchers using interpretive phenomenological analysis. Ethical approval was approved by the Office for Research Ethics Committees Northern Ireland (Reference: 22/NI/0107). ResultsAnalysis generated six group experiential themes: the lived experience of appetite loss, functional decline and temporal coping, weight loss a visual metaphor of concern, social withdrawal and vulnerability, the emotional toll of eating challenges and psychological strain amidst a lack of information about cachexia. ConclusionThis is the first qualitative study exploring the lived experience of renal cachexia for patients and carers. Our study highlights that psycho-social and educational support is urgently needed. Additionally, healthcare professionals need better information provision to help them to recognise and respond to the needs of this population. Further research is required to develop models of holistic support which could help patients and carers cope with the impact of renal cachexia and optimally manage this syndrome within the family unit. RegistrationN/A.

Recurrent patellar dislocation: personalised therapy or operative treatment? The REPPORT randomised trial protocol

IntroductionRecurrent patellar dislocation is a debilitating musculoskeletal condition, affecting mainly adolescents and adults under the age of 30. It can persist for many decades, causing pain and cartilage and soft-tissue...

Effectiveness of digital Cognitive-Behavioural Therapy for Insomnia in patients with musculoskeletal complaints and insomnia in primary care physiotherapy: study protocol for a randomised controlled trial

IntroductionInsomnia is prevalent among patients visiting physiotherapists due to musculoskeletal complaints and associated with poorer pain prognosis. Cognitive-Behavioural Therapy for Insomnia (CBT-I) may be effective for improving sleep quality and...

Machine Learning Model for Anesthetic Risk Stratification for Gynecologic and Obstetric Patients: Cross-Sectional Study Outlining a Novel Approach for Early Detection.

Preoperative evaluation is important, and this study explored the application of machine learning methods for anesthetic risk classification and the evaluation of the contributions of various factors. To minimize the effects of confounding variables during model training, we used a homogenous group with similar physiological states and ages undergoing similar pelvic organ-related procedures not involving malignancies. Data on women of reproductive age (age 20-50 years) who underwent gestational or gynecological surgery between January 1, 2017, and December 31, 2021, were obtained from the National Taiwan University Hospital Integrated Medical Database. We first performed an exploratory analysis and selected key features. We then performed data preprocessing to acquire relevant features related to preoperative examination. To further enhance predictive performance, we used the log-likelihood ratio algorithm to generate comorbidity patterns. Finally, we input the processed features into the light gradient boosting machine (LightGBM) model for training and subsequent prediction. A total of 10,892 patients were included. Within this data set, 9893 patients were classified as having low anesthetic risk (American Society of Anesthesiologists physical status score of 1-2), and 999 patients were classified as having high anesthetic risk (American Society of Anesthesiologists physical status score of >2). The area under the receiver operating characteristic curve of the proposed model was 0.6831. By combining comorbidity information and clinical laboratory data, our methodology based on the LightGBM model provides more accurate predictions for anesthetic risk classification. Research Ethics Committee of the National Taiwan University Hospital 202204010RINB; https://www.ntuh.gov.tw/RECO/Index.action.

Environmental impact of infant feeding type, accessories used and maternal dietary habits: The GREEN MOTHER-I project, a cross-sectional study protocol

IntroductionBreastfeeding (BF) is the healthiest form of nutrition for babies and is recommended exclusively (EBF) for at least the first six months of life. The carbon footprint of formula feeding (FF) has been studied, but that of BF is unknown.AimTo identify the environmental impact of three types of infant feeding taking into account the accessories needed and the diet of postpartum women in the baby’s first month of life.MethodsThis is a multicentre, cross-sectional study conducted in the Barcelona North Metropolitan Area (Catalonia, Spain). The participating sites are primary care settings that will recruit 408 postpartum women (4–6 weeks) as per inclusion/exclusion criteria. The data will be collected through a GREEN MOTHER Survey that includes 4 dimensions: 1) socio-demographic and clinical data; 2) data on the newborn and accessories used in infant feeding; 3) general data on the mother's diet (food consumption habits), and 4) recording of 24 h of the mother’s diet. The data analysis will be performed to check the prevalence of infant feeding types at birth and month 1, as well as a comparative analysis of three types of infant feeding on environmental impact (climate change; water consumption, and scarcity).Ethics.This project was approved by the Research Ethics Committee of the Jordi Gol i Gurina University Institute Foundation for Primary Health Care Research (IDIAP) under code 22/101-P dated 22/02/2023.DiscussionA second phase of the GREEN MOTHER study is planned, which will consist of an educational intervention to promote breastfeeding, nutrition and sustainability. This intervention will be based on the results obtained in Phase I. We expect that the project results – through the publication and dissemination of scientific papers and reports among relevant stakeholders (association of community midwives, healthcare and primary care attention professionals and the public) – will increase public awareness of breastfeeding and its impact on sustainability.Trial registrationBoth phases of the GREEN MOTHER study protocol were registered in ClinicalTrials.gov, NCT05729581.

Treating severe paediatric asthma with mepolizumab or omalizumab: a protocol for the TREAT randomised non-inferiority trial

IntroductionA minority of school-aged children with asthma have persistent poor control and experience frequent asthma attacks despite maximal prescribed maintenance therapy. These children have higher morbidity and risk of death....

Trial to assess the tolerability of using felodipine to upregulate autophagy as a treatment of Huntington’s disease (FELL-HD): a phase II, single-centre, open-label, dose-finding trial protocol

IntroductionHuntington’s disease (HD) is an autosomal dominant neurodegenerative disorder that presents with a progressive movement disorder along with cognitive and psychiatric problems. It is caused by a Cytosine-adenin-guanine (CAG) expansion...

Evaluating the impact of the global evidence, local adaptation (GELA) project for enhancing evidence-informed guideline recommendations for newborn and young child health in three African countries: a mixed-methods protocol

BackgroundPoverty-related diseases (PRD) remain amongst the leading causes of death in children under-5 years in sub-Saharan Africa (SSA). Clinical practice guidelines (CPGs) based on the best available evidence are key to strengthening health systems and helping to enhance equitable health access for children under five. However, the CPG development process is complex and resource-intensive, with substantial scope for improving the process in SSA, which is the goal of the Global Evidence, Local Adaptation (GELA) project. The impact of research on PRD will be maximized through enhancing researchers and decision makers’ capacity to use global research to develop locally relevant CPGs in the field of newborn and child health. The project will be implemented in three SSA countries, Malawi, South Africa and Nigeria, over a 3-year period. This research protocol is for the monitoring and evaluation work package of the project. The aim of this work package is to monitor the various GELA project activities and evaluate the influence these may have on evidence-informed decision-making and guideline adaptation capacities and processes. The specific project activities we will monitor include (1) our ongoing engagement with local stakeholders, (2) their capacity needs and development, (3) their understanding and use of evidence from reviews of qualitative research and, (4) their overall views and experiences of the project.MethodsWe will use a longitudinal, mixed-methods study design, informed by an overarching project Theory of Change. A series of interconnected qualitative and quantitative data collections methods will be used, including knowledge translation tracking sheets and case studies, capacity assessment online surveys, user testing and in-depth interviews, and non-participant observations of project activities. Participants will comprise of project staff, members of the CPG panels and steering committees in Malawi, South Africa and Nigeria, as well as other local stakeholders in these three African countries.DiscussionOngoing monitoring and evaluation will help ensure the relationship between researchers and stakeholders is supported from the project start. This can facilitate achievement of common goals and enable researchers in South Africa, Malawi and Nigeria to make adjustments to project activities to maximize stakeholder engagement and research utilization. Ethical approval has been provided by South African Medical Research Council Human Research Ethics Committee (EC015-7/2022); The College of Medicine Research and Ethics Committee, Malawi (P.07/22/3687); National Health Research Ethics Committee of Nigeria (01/01/2007).

Sleep Behavior in Royal Australian Navy Shift Workers by Shift and Exposure to the SleepTank App.

Rotating shiftwork schedules are known to disrupt sleep in a manner that can negatively impact safety. Consumer sleep technologies (CSTs) may be a useful tool for sleep tracking, but the standard feedback provided by CSTs may not be salient to shift-working populations. SleepTank is an app that uses the total sleep time data scored by a CST to compute a percentage that equates hours of sleep to the fuel in a car and warns the user to sleep when the "tank" is low. Royal Australian Navy aircraft maintenance workers operating on a novel rotational shift schedule were given Fitbit Versa 2s to assess sleep timing, duration, and efficiency across a 10-week period. Half of the participants had access to just the Fitbit app while the other half had access to Fitbit and the SleepTank app. The goal of this study was to evaluate differences in sleep behavior between shifts using an off-the-shelf CST and to investigate the potential of the SleepTank app to increase sleep duration during the 10-week rotational shift work schedule. Royal Australian Navy volunteers agreed to wear a Fitbit Versa 2 with the SleepTank app (SleepTank condition), or without the SleepTank app (Controls), for up to 10 weeks from May to July 2023 during the trial of a novel shift rotation schedule. Participants from across 6 units worked a combination of early (6:00 AM to 2:00 PM), day (7:30 AM to 4:30 PM), late (4:00 PM to 12:00 AM), and night shifts (12:00 AM to 6:00 AM) or stable day shifts (6:00 AM to 4:00 PM). Differences in sleep behavior (time in bed, total sleep time, bedtime, wake time, sleep efficiency [SE]) between conditions and shift types were tested using Analysis of Variance. This study was approved by the Australian Departments of Defence and Veterans' Affairs Human Research Ethics Committee. Thirty-four participants completed the full study (n = 17 Controls; n = 17 SleepTank). There was a significant effect of shift type on 24-hour time in bed (TIB24; F(4,9) = 8.15, P < .001, η2 = 0.15) and total sleep time (TST24; F(4,9) = 8.54, P < .001, η2 = 0.18); both were shorter in early shifts and night shifts compared to other shift types. TIB24 and TST24 were not significantly different between conditions, but there was a trend for greater SE in the SleepTank condition relative to Controls (F(1,9) = 2.99, P = .08, η2 = 0.11). Sleep data collected by Fitbit Versa 2s indicated shorter sleep duration (TIB24, TST24) for Royal Australian Navy workers during early and late shifts relative to stable day shifts. Access to the SleepTank app did not greatly influence measures of sleep duration but may be protective against fatigue by affecting SE. Further research is needed to evaluate the utility of the SleepTank app as a means of improving sleep hygiene in real-world, shift-working environments.