Research Ethics Research Articles

Special Issue of the Asian Journal of Business Ethics on Global Survey of Business Ethics (GSBE) Reports 2022–2024 from Asia, Australia, and Russia: Australia

AbstractThis report examines a study focused on current interest areas and themes of business ethics in Australia as discussed in the Australian media (major national and State newspapers) across the years 2019–2022, using content analysis and stakeholder frame of focus. The identified themes are then compared with themes identified in the Global Survey of Business Ethics 2022–2024. These themes provide a framework to compare with themes identified as important for teaching and research through a survey of Australian university educators in business schools involved in ethics teaching and research in South Australia and Western Australia. Findings indicate that ethics and ethical concerns appear across a range of media publications in Australia which in turn is placing pressure on businesses to respond to this ethics talk in the media in explaining or justifying their actions. Although no particular pattern is identified from responses, some topics are gaining more prominence such as climate change and artificial intelligence, both in the media and in university courses and research. Topics of discussion were ranked from very important to important. It is concluded that ethical issues are important for Australian business and business is responding. Key ethical issues include climate change and sustainability, governance, government and transparency, and organizational culture with ethical issues of interest to Australia featuring including sport, corporate misconduct, and Indigenous issues.

Study protocol: Optimising patient positioning for the planning of accelerated partial breast radiotherapy for the integrated magnetic resonance linear accelerator: OPRAH MRL

BackgroundAccelerated partial breast irradiation (APBI) is an accepted treatment option for early breast cancer. Treatment delivered on the Magnetic Resonance integrated Linear Accelerator (MRL) provides the added assurance of improved soft tissue visibility, important in the delivery of APBI. This technique can be delivered in both the supine and prone positions, however current literature suggests that prone treatment on the MRL is infeasible due to physical limitations with bore size. This study aims to investigate the feasibility of positioning patients on a custom designed prone breast board compared with supine positioning on a personalised vacuum bag. Geometric distortion, the relative position of Organs at Risk (OAR) to the tumour bed and breathing motion (intrafraction motion) will be compared between the supine and prone positions. The study will also investigate the positional impact on dosimetry, patient experience, and position preference.MethodsUp to 30 patients will be recruited over a 12-month period for participation in this Human Research Ethics Committee approved exploratory cohort study. Patients will be scanned on the magnetic resonance imaging (MRI) Simulator in both the supine and prone positions as per current standard of care for APBI simulation. Supine and prone positioning comparisons will all be assessed on de-identified MRI image pairs, acquired using appropriate software. Patient experience will be explored through completion of a short, anonymous electronic survey. Descriptive statistics will be used for reporting of results with categorical, parametric/non-parametric tests applied (data format dependent). Survey results will be interpreted by comparison of percentage frequencies across the Likert scales. Thematic content analysis will be used to interpret qualitative data from the open-ended survey questions.DiscussionThe results of this study will be used to assess the feasibility of treating patients with APBI in the prone position on a custom designed board on the MRL. It may also be used to assist with identification of patients who would benefit from this position over supine without the need to perform both scans. Patient experience and technical considerations will be utilised to develop a tool to assist in this process.Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN1262400067583. Registered 28th of May 2024. https://www.anzctr.org.au/ACTRN12624000679583.aspx

Vulnerability, social value and the equitable sharing of benefits from research: beyond the placebo and access debates.

The vulnerability of research participants is a critical topic for the 2024 revision of the Declaration of Helsinki, with the proposal to include "social value. " However, this proposal has been withdrawn and the relationship between the two concepts has not been clarified. This paper attempts to clarify: (1) the recent reform for the ethical inclusion of vulnerable study participants to promote diversity; (2) the social value, prerequisite for everyone, especially for those who are vulnerable and the most in need; (3) the requirements for promoting the inclusion of vulnerable participants, in particular the review of the norms for placebo-controlled trials and post-trial access; (4) finally, the direction of research ethics reform to achieve social value and equitable global health.

Severe hypocalcaemia and hypophosphatemia following Denosumab administration in a multi-comorbidity patient

The case is presented of an elderly patient (DCP) with extensive medical history, including osteoporosis, who developed hypocalcaemia and hypophosphataemia whilst treated with denosumab, while prescribed concomitant calcium and vitamin D therapies. The management of this complex case involved a multidisciplinary team (MDT) approach, incorporating the patient’s wishes. It included discontinuation of denosumab and intravenous (IV) and oral mineral supplementation that yielded gradual amelioration of calcium and phosphate levels. This case demonstrates the importance of vigilant monitoring and appropriate management in patients receiving denosumab, particularly those with multiple comorbidities. It carries important considerations for using denosumab for osteoporosis treatment in patients with complex medical backgrounds. Ethical clearance waiver was granted by the Trust Research Ethics Committee on 18/01/2024.

Domain-specific research methods in instructed second language acquisition: A next step for research integrity and impact

Abstract Instructed second language acquisition (ISLA) is one of the fastest growing areas of applied linguistics. With this tremendous potential comes great responsibility for robust, ethical, and transparent research methods that are responsive to and tailored for the ISLA domain. This article highlights unique characteristics of ISLA research, provides a current landscape of methodological trends within ISLA, and makes specific recommendations for research methods in future ISLA studies. I begin by briefly operationalizing ISLA and articulating some of the main research questions and overarching goals within ISLA, as well as the nature and ultimate aims of ISLA research. Next, the most unique methodological challenges for ISLA research are reviewed, including the use of intact classes and heterogeneous small participant pools, cross-sectional studies, using one’s own students for research, and individual differences. This is followed by a discussion of several current trends in ISLA research methods, including examining the process of learning/development, conducting practice-based research, expanding our conceptualization of instructional contexts, replication studies, especially with bi/multilingual learners in diverse contexts, refining our methods with an eye for ethics and justice, equity, diversity, and inclusion, and conducting open, transparent research that has potential for real-world impact and which dialogues with multiple stakeholders at all stages. I conclude by highlighting that, as ISLA continues as an independent research domain, the development and implementation of strong research methods tailored for ISLA is critical for research integrity and to make the greatest strides in understanding language acquisition processes and effective pedagogical interventions in diverse instructional contexts.

Preterm birth as a determinant of neurodevelopment and cognition in children (PRENCOG): protocol for an exposure-based cohort study in the UK

IntroductionPreterm birth (PTB) is strongly associated with encephalopathy of prematurity (EoP) and neurocognitive impairment. The biological axes linking PTB with atypical brain development are uncertain. We aim to elucidate the...

Relationship between paraspinal muscle morphology and function in different directions in a healthy Chinese population at different ages: a cross-sectional study

BackgroundParaspinal muscle degeneration occurs with age; however, it is unknown whether strength and endurance change with muscle cross-sectional area (CSA) and fatty infiltration (FI) parameters in Chinese healthy individuals.MethodsA total of 94 asymptomatic Chinese volunteers were enrolled in this study. The participants were divided into three groups: young (20–39 years old, n = 27), middle-aged (40–59 years old, n = 49), and elderly (≥ 60 years old, n = 18). CSA and FI of the psoas (PS), quadratus lumborum (QL), multifidus (MF), and erector spinae (ES) were measured using magnetic resonance imaging. The Bionix Sim3 Pro was used to evaluate the maximum isometric torque and the Ito test to evaluate endurance.ResultsThe CSA of the PS and ES in the elderly group was smaller than those in the other groups, while the CSA of QL in the young group was larger than that in the other groups. There were differences in the MF and ES FI among the three groups. The maximum isometric torque and endurance test time decreased with increasing age; however, these differences were not statistically significant. Maximum isometric torque positively correlated with the average paraspinal muscle CSA and negatively correlated with the torque and FI of the MF and ES muscles. The endurance test was found to be positively correlated with the FCSA of the MF and to be negatively correlated with the FI of the MF and ES. PS and QL can predict the maximum isometric torque, and MF and PS can predict the endurance time.ConclusionMF and ES showed earlier degeneration than PS and QL. MF is the first paraspinal muscle to undergo functional area atrophy, and it plays an important role in the endurance test. The maximum moment of equal length in all directions of the lumbar spine is not completely symmetrical, but it is correlated with the imaging parameters of the paraspinal muscles. QL and PS were more activated in the lumbar activity.Trial registrationThe study was registered in Chinese Clinical Trial Registry and the registration number is ChiCTR2000039073 on 15/10/2020 (https://www.chictr.org.cn/showproj.html?proj=62785). Ethical Approval was obtained from the Peking University Third Hospital Medical Science Research Ethics Committee (IRB00006761-M2020305).

A CRITICAL ANALYSIS OF KEY PHILOSOPHICAL, METHODOLOGICAL AND ETHICAL RESEARCH ISSUES IN RELATION TO TEACHER’S PERCEPTION ON THE EFFECT OF ASSESSMENT ON COGNITIVE DEVELOPMENT OF THREE TO FIVE YEARS CHILDREN IN ENGLAND

The study critically analysed key philosophical, methodological, and ethical research issues related to teachers' perceptions of the effect of assessment on the cognitive development of three to five years of children in England. The study revealed philosophical issues such as tensions between positivist and interpretivist paradigms in understanding assessment’s impact and debates around the nature of childhood, learning, and development. Methodological issues such as challenges in measuring cognitive development in young children chosen methods’ potential impact on finding and interpretation. Ethical issues include concerns about labelling, stigma, and potential long-term consequences. Balancing accountability with development sensitivity and equity. The findings showed that teachers’ perceptions are influenced by philosophical beliefs, methodological approaches and ethical consideration.<p> </p><p><strong> Article visualizations:</strong></p><p><img src="/-counters-/soc/0703/a.php" alt="Hit counter" /></p>

34 The influence and interaction of nutrition with the immune system in companion animal models

Abstract Understanding the impacts of nutrients in a species-specific manner has both practical and academic benefits for improving animal health. Therefore, species-specific animal models and research reagents are crucial to understanding molecular and physiological pathways. However, limitations in repeatable, descriptive models, sample size, and the ethics of companion animal research result in often needing to make inferences from human, murine, and other related immunology and nutrition research models. Recent companion animal work has focused on the impact of key nutrients in animal diets, including fat-soluble vitamins D, and E, omega-3 polyunsaturated fatty acids (PUFA), overall amino acid and energy balance over the lifespan, minerals including zinc and selenium, and feed additives such as probiotics and beta glucans. The selected research model, samples able to be collected, and available reagents for sample analysis will impact potential outcomes and inferences made from the data, including both acute to chronic impacts. From a theoretical standpoint, the balance between nutrient supplementation and impact includes understanding nutrients and responses of a model system in both deficiency and therapeutic level settings. For example, when supplementing Vitamin D, Vitamin E, or omega-3 polyunsaturated fatty acids, inclusion above currently recommended levels may optimize immune function, such as pathogen clearance, improved vaccine titer responses, or reduce inflammation. For other nutrients associated with immunomodulation such as zinc, additional chronic pharmacological supplementation may inhibit certain aspects of immune function, much like a deficiency scenario. Overstimulation of the immune system through nutrient supplementation may also impact the necessary modulation and repair roles that immune cells such as macrophages play in wound healing and anti-inflammatory responses. Continued work in nutritional immunology will further enhance our understanding of the power of nutrition and diet to improve health in companion animals.

Community-based dementia risk management and prevention program for Aboriginal Australians (DAMPAA): a randomised controlled trial study protocol

IntroductionAboriginal and Torres Strait Islander peoples are the First Peoples of Australia. Up to 45% of dementia in these populations is due to potentially modifiable risk factors. The Dementia Prevention...

Evaluation of the usability and acceptability of the P-STEP® mobile app: feasibility study protocol

BackgroundThe new P-STEP® (Personalised Space Technology Exercise Platform) app is designed to bring together tailored exercise guidance and up-to-date air quality information. The app allows individuals to plan outdoor exercise walking routes while minimising their exposure to air pollution. Individuals with chronic long-term conditions, particularly respiratory and cardiovascular conditions, can use the app in order to minimise the risk of their symptoms being exacerbated by pollution, while still gaining the benefits of outdoor exercise.MethodsThis study will measure the usability and acceptability of the P-STEP® app. The study will take the form of a single-arm 12-week app pilot study based in Leicestershire, United Kingdom (UK). We will recruit a maximum of 380 participants from an existing cohort study to pilot the app for 12 weeks. Questionnaire data will be collected at three timepoints, baseline, 6 weeks and 12 weeks. The primary outcome is the System Usability Scale at 12 weeks. Secondary outcomes include the User Engagement Scale Short Form, SF-12, Recent Physical Activity Questionnaire (RPAQ), bespoke, app specific usability questions, and feasibility outcomes. Additional data collected includes participant demographic information, technology self-efficacy and adverse events. Weekly anonymised usage data from the app will also be collected by the app team and analysed separately to complement the questionnaire data.DiscussionThis study will help us better understand the feasibility and acceptability of using the P-STEP® in the community. The results will also help inform future studies.Ethics and disseminationThis study has received ethical approval from the South West Frenchay Research Ethics (23/SW/0060) Committee. There is no need for further approval from the Health Research Authority as the study is not taking place in the NHS. The ClinicalTrials.gov ID number is NCT05830318.

Transgender-Specific Differentiated HIV Service Delivery Models in the South African Public Primary Health Care System (Jabula Uzibone): Protocol for an Implementation Study.

Almost 60% of transgender people in South Africa are living with HIV. Ending the HIV epidemic will require that transgender people successfully access HIV prevention and treatment. However, transgender people often avoid health services due to facility-based stigma and lack of availability of gender-affirming care. Transgender-specific differentiated service delivery (TG-DSD) may improve engagement and facilitate progress toward HIV elimination. Wits RHI, a renowned South African research institute, established 4 TG-DSD demonstration sites in 2019, with funding from the US Agency for International Development. These sites offer unique opportunities to evaluate the implementation of TG-DSD and test their effectiveness. The Jabula Uzibone study seeks to assess the implementation, effectiveness, and cost of TG-DSD for viral suppression and prevention-effective adherence. The Jabula Uzibone study collects baseline and 12-month observation checklists at 8 sites and 6 (12.5%) key informant interviews per site at 4 TG-DSD and 4 standard sites (n=48). We seek to enroll ≥600 transgender clients, 50% at TG-DSD and 50% at standard sites: 67% clients with HIV and 33% clients without HIV per site type. Participants complete interviewer-administered surveys quarterly, and blood is drawn at baseline and 12 months for HIV RNA levels among participants with HIV and tenofovir levels among participants on pre-exposure prophylaxis. A subset of 30 participants per site type will complete in-depth interviews at baseline and 12 months: 15 participants will be living with HIV and 15 participants will be HIV negative. Qualitative analyses will explore aspects of implementation; regression models will compare viral suppression and prevention-effective adherence by site type. Structural equation modeling will test for mediation by stigma and gender affirmation. Microcosting approaches will estimate the cost per service user served and per service user successfully treated at TG-DSD sites relative to standard sites, as well as the budget needed for a broader implementation of TG-DSD. Funded by the US National Institutes of Mental Health in April 2022, the study was approved by the Human Research Ethics Committee at University of Witwatersrand in June 2022 and the Duke University Health System Institutional Review Board in June 2023. Enrollment began in January 2024. As of July 31, 2024, a total of 593 transgender participants have been enrolled: 348 are living with HIV and 245 are HIV negative. We anticipate baseline enrollment will be complete by August 31, 2024, and the final study visit will take place no later than August 2025. Jabula Uzibone will provide data to inform HIV policies and practices in South Africa and generate the first evidence for implementation of TG-DSD in sub-Saharan Africa. Study findings may inform the use of TG-DSD strategies to increase care engagement and advance global progress toward HIV elimination goals. DERR1-10.2196/64373.

“The seven principles of universal design of research”: how to increase user diversity in mainstream research

PurposeUser diversity has been discussed in many fields of study for decades. Nevertheless, some cohorts are rarely included in mainstream research. According to the concept of universal design of research (UDR), people with disabilities should be more often included in participant pools. There is, however, a need for certain methodological considerations to achieve UDR.Design/methodology/approachThe suggested guidelines are based upon existing guidelines and research in addition to key takeaways from studies conducted by the authors over the past 15 years. Six studies are used to show how the guidelines can be applied in research involving three example cohorts, namely people with dyslexia, aphasia and intellectual disability.FindingsExtensive guidelines are needed to increase user inclusion in mainstream studies and support researchers in conducting purposeful and ethical research. The suggested guidelines should be examined for other cohorts to ensure that all types of user needs are accommodated.Research limitations/implicationsThis study contributes with methodological approaches to enhance inclusion of all types of participants in mainstream research.Originality/valueThe main contribution is The seven principles of UDR, a further development of the original principles for UDR.

Acceptability and timing considerations when administering patient-reported outcome measures (PROMs) among people with chronic health conditions who are culturally and linguistically diverse (CALD): a qualitative study protocol

IntroductionPatient-reported outcome measures (PROMs) are validated and standardised questionnaires that capture patients’ own reports of their symptoms, functioning and well-being. PROMs can facilitate communication between patients and clinicians, reduce symptom...

Protocol for a clinically annotated biorepository of samples from Australian immune-compromised patients to investigate the host–microbiome interaction

IntroductionThe human gut microbiota has the potential to modulate the outcomes of several human diseases. This effect is likely to be mediated through interaction with the host immune system. This...

Linking trial data to ICES: incorporating a prompt in a research ethics protocol submission platform in Southwestern Ontario

IntroductionThe linkage of trial data with large administrative databases can enable long-term passive follow-up of participants at a significantly lower cost than direct participant follow-up in a study. Nonetheless, many researchers are unaware of this opportunity and/or the regulatory requirements to facilitate linkage. ApproachIn 2017, Western University Canada’s Office of Human Research Ethics (OHRE) incorporated a prompt into its online protocol submission platform, asking researchers if they have considered linking their trial data with ICES. ICES is a not-for-profit research and analytics institute in Ontario, Canada with a repository of over 100 data holdings comprised of record-level, coded and linkable health and health-related data. If a researcher selects ‘yes’ to this prompt, they are provided with additional information about ICES, identifiers required for linkage, and language to be included in letters of consent. ResultsThe incorporation of a prompt into the ethics protocol submission platform allowed the OHRE to identify protocols interested in linking trial data with ICES. Over the past 5 years, an average of 2.6% of protocols submitted to the Health Sciences Research Ethics Board included an intent to link data with ICES. The OHRE verified that these protocols had carefully considered regulatory requirements, which helped to streamline the ethical, privacy, and legal processes required for linkage. ConclusionIncorporating a prompt into ethics protocol submission platforms can help to streamline regulatory processes and promote awareness about opportunities to link trial data with large administrative databases.

Ethical considerations of use of hold-out sets in clinical prediction model management

AbstractClinical prediction models are statistical or machine learning models used to quantify the risk of a certain health outcome using patient data. These can then inform potential interventions on patients, causing an effect called performative prediction: predictions inform interventions which influence the outcome they were trying to predict, leading to a potential underestimation of risk in some patients if a model is updated on this data. One suggested resolution to this is the use of hold-out sets, in which a set of patients do not receive model derived risk scores, such that a model can be safely retrained. We present an overview of clinical and research ethics regarding potential implementation of hold-out sets for clinical prediction models in health settings. We focus on the ethical principles of beneficence, non-maleficence, autonomy and justice. We also discuss informed consent, clinical equipoise, and truth-telling. We present illustrative cases of potential hold-out set implementations and discuss statistical issues arising from different hold-out set sampling methods. We also discuss differences between hold-out sets and randomised control trials, in terms of ethics and statistical issues. Finally, we give practical recommendations for researchers interested in the use hold-out sets for clinical prediction models.

A surgical preadmission pharmacist service in a tertiary paediatric hospital: a pilot study

AbstractBackgroundPharmacist surgical preadmission review is common in adult healthcare settings, however there is little evidence of this practice in the paediatric setting. This research describes a pilot surgical preadmission pharmacist service in a paediatric hospital.AimTo evaluate the impact of a surgical preadmission pharmacist service on patient flow and the quality of medication management.MethodA retrospective review (2 months) was conducted to compare an intervention group (1 May 2019–30 June 2019) to historical baseline (1 October 2018–30 November 2018). Children and adolescents (aged 0–18 years) presenting for elective surgery and overnight admission were included. Relevant clinical data and timestamps were extracted from the electronic medical record. Multiple linear regression models were built to examine the difference in outcomes between the control and intervention groups. This project was exempt due to the local policy requirements that constitute research by the Queensland Children's Hospital Human Research Ethics Committee (Reference no: LNR/19/QCHQ/53406). The justification for this exemption was as follows: the study presented no foreseeable risk of patient harm as it involved evaluation of an established standard of clinical care and involved the use of existing collections of records that contain only non‐identifiable patient data.ResultsIn total, 135 patients were included in the baseline and 96 patients were included in the intervention group. The intervention group had statistically significant lower time to best possible medication history (BPMH) by 47.57 h (95% confidence interval [CI] −53.25 to −41.89, p < 0.001). Time to prescription of home medications was significantly reduced in the intervention group by 5.26 h (95% CI −10.45 to −0.08, p = 0.05). There was no difference in proportion of patients with home medications omitted (71–62%, p = 0.38) or requiring modification (14–12%, p = 0.58) between the two groups.ConclusionImplementation of a surgical preadmission pharmacist service in our paediatric hospital demonstrated earlier BPMH documentation and prescription of home medications, without negative effects on perioperative patient flow.

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...