Ethical Review Research Articles

Beyond ethical guidelines: upholding Aboriginal and Torres Strait Islander ethical governance in health and medical research. A scoping review.

To examine what ethics approvals are being sought for Aboriginal and Torres Strait Islander health and medical research, and to determine what proportion of this research upholds Aboriginal and Torres Strait Islander ethical governance via an Aboriginal and Torres Strait Islander community-controlled human research ethics committee (AHREC) by jurisdiction and funding body type. Scoping review of all original, peer-reviewed health and medical literature published over a 5-year period (January 2018 to December 2022). Extending on a previous review, the search tool LIt.search was used to access all literature relating to Aboriginal and Torres Strait Islander health and medical research. 589 eligible publications were included from the parent review, and a further 1703 publications were identified from the updated search. A total of 945 publications were included. A substantial number of ethics approvals were obtained from government-based ethics committees (394, 41.7%). More than half of the publications reported obtaining institutional ethics approval (514, 54.4%). Less than half (400, 42.3%) reported obtaining AHREC approval. Almost one-third of publications were on research that was conducted in states or territories where there is no AHREC (334, 35.3%). Publications did not always report obtaining AHREC approvals, including in jurisdictions where one operates. We found a concerning lack of Aboriginal and Torres Strait Islander ethical governance reported in health and medical research. Acknowledging that Aboriginal and Torres Strait Islander ethics guidelines and AHRECs were established due to harm caused to communities, these results suggest a high risk, with research not consistently being deemed safe, respectful and beneficial with appropriate AHREC ethics review and approval. We join calls for the establishment of AHRECs in all jurisdictions and nationally. Furthermore, we urge funding bodies and institutions to uphold requirements for Aboriginal and Torres Strait Islander ethical governance in research and funding agreements, as well as institutional policies and procedures.

Global comparison of research ethical review protocols: insights from an internationalresearch collaborative.

Global comparison of research ethical review protocols: insights from an internationalresearch collaborative.

Evaluation of caesarean rates according to Robson classification using a newly developed smart phone application in a tertiary center in Sri Lanka: a comparative study

ObjectiveCaesarean section (CS) rates in Sri Lanka have escalated significantly, with projections indicating that over half of all births may involve CS by 2025. To address this rise and mitigate maternal morbidity, it is essential that CS procedures are medically justified. This study evaluates RobsApp®, a novel smartphone application designed to collect high-quality prospective data on CS rates based on the Robson classification.MethodsThe study utilized RobsApp® for data collection in the Professorial Unit of De Soysa Hospital for Women (DSHW), Sri Lanka. Data were collected prospectively from 1,712 deliveries between April and October 2019. The analysis focused on CS rates across different Robson categories and the quality of the collected data, comparing them with previous data obtained using traditional methods.ResultsThe overall CS rate was 33.0%, with Robson category 5a accounting for most cases. Emergency CS constituted 49.6% of all procedures, with cardiotocograph (CTG) abnormalities being the leading indication. The quality of the data collected through RobsApp® met the standards recommended by the Robson guidance, as evidenced by the study's ability to accurately categorize deliveries and assess CS rates.ConclusionsRobsApp® has proven to be an effective tool for prospective data collection, aligning well with Robson guidelines and facilitating high-quality data gathering. The study reveals a rising trend in CS rates at DSHW, particularly for reasons beyond previous CS. The inclusion of demographic data and birth weight analysis in future studies will enhance comparisons and insights into reducing CS rates.EthicsEthical approval was obtained from the Ethical Review Committee, Faculty of Medicine, University of Colombo (Ref – EC-19–024) which waived the need for individual consent. Study adhered to the Helsinki Declaration.

Evaluation of the protective efficacy of OlysetPlus ceiling nets for reduction of malaria incidence in children in Homa Bay County, Kenya: a cluster-randomised controlled study protocol

IntroductionMalaria is still a major health problem in sub-Saharan Africa, where 98% of global malaria mortality occurs. In addition, the spread of Plasmodium falciparum with partial artemisinin resistance in East...

Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial

IntroductionLong-acting insulin analogues are the standard of care for people with type 1 diabetes (T1D) in high-income countries but remain largely inaccessible and understudied in low-resource settings. In settings where...

SELective defunctioning Stoma Approach in low anterior resection for rectal cancer (SELSA): Protocol for a prospective study with a nested randomized clinical trial investigating stoma-free survival without major LARS following total mesorectal excision.

Accumulated data suggest that routine use of defunctioning stoma in low anterior resection for rectal cancer may cause kidney injury, bowel dysfunction and a higher risk of permanent stomas. We aim to study whether avoidance of a diverting stoma in selected patients is safe and reduces adverse consequences. SELSA is a multicentre international prospective observational study nesting an open-label randomized clinical trial. All patients with primary rectal cancer planned for low anterior resection are eligible. Patients operated with curative intent, aged <80 years, with an American Society of Anaesthesiologists' fitness grade I or II, and a low predicted risk of anastomotic leakage are eligible to 1:1 randomization between no defunctioning stoma (experimental arm) or a defunctioning stoma (control arm). The primary outcome is the composite measure of 2-year stoma-free survival without major low anterior resection syndrome (LARS). Secondary outcomes include anastomotic leakage, postoperative mortality, reinterventions, stoma-related complications, quality of life measures, LARS score, and permanent stoma rate. To be able to state superiority of any study arm regarding the main outcome, with 90% statistical power and assuming 25% attrition, we aim to enrol 212 patients. Patient inclusion will commence in the autumn of 2024. The SELSA study is investigating a tailored approach to defunctioning stoma use in low anterior resection for rectal cancer in relation to the risk of anastomotic leakage. Our hypothesis is that long-term effects will favour the selective approach, enabling some patients to avoid a defunctioning stoma. Swedish Ethical Review Authority approval (2023-04347-01, 2024-02418-02 and 2024-03622-02), Regional Ethics Committee Denmark (H-24014463), and ClinicalTrials.gov (NCT06214988).

Willingness to donate eyes and associated factors among adults in Addis Ababa City, Ethiopia: a mixed-methods approach

ObjectiveThis study intended to assess willingness to donate eyes and associated factors among adults in Addis Ababa City, Ethiopia.Methods and analysisThis study used a triangulated phenomenological mixed-methods design, involving 1293...

Accessing medical records for research in South African public hospitals: a reflective narrative

BackgroundAccess to medical data is important for health system research in South Africa. Researchers must obtain authorization from gatekeepers to enter hospitals and access medical records. They engage with street-level bureaucrats to retrieve specific records and extract necessary data. This paper reflects on our experiences accessing patient records in a nationally representative sample of 60 public hospitals in South Africa.MethodsWe chose narrative inquiry to deeply explore researchers' experiences accessing medical records in South African public hospitals. This qualitative method focuses on individuals' stories and personal experiences, providing rich, detailed insights into complex, context-dependent phenomena. Field reports documented our reflections and experiences during each hospital visit. Additionally, we conducted debriefing sessions to further explore these experiences. The themes that emerged from the field reports and debriefing sessions prompted us to delve deeper into the research process. To explore these themes, we conducted a focus group discussion (FGD) with all researchers. The FGD transcript and field reports were analyzed using MAXQDA. We adopted Gibbs's reflective model, incorporating structured debriefing steps, to present our findings.ResultsOur reflections highlight the challenges encountered during the ethical review process, engagements with numerous gatekeepers, and street-level bureaucracy. The ethics review process experienced significant delays. Obtaining permission from various gatekeepers was arduous and complex, often presenting logistical challenges. We had both positive and negative experiences with the street-level bureaucrats, including hospital staff responsible for creating, curating, and safeguarding medical records. Some exhibited resistance that appeared to stem from their frustrations with superiors. Public hospital records were mostly poorly curated.ConclusionEthical review is essential for guiding complex research like access to abortion. However, an overcautious approach might impede needed research with vulnerable populations. Researchers need to be up to date with local processes and have sufficient resources to gain gatekeepers’ permission to access public hospitals. Understanding street-level bureaucracy is imperative for researchers who need to interact with various hospital personnel to access medical records. The state of record-keeping in South African public hospitals may reflect the overall state of the health system, including examples of excellence and mediocrity.

Application of metagenomic next-generation sequencing (mNGS) to describe the microbial characteristics of diabetic foot ulcers at a tertiary medical center in South China

BackgroundDiabetic foot ulcers (DFUs) are characterized by dynamic wound microbiome, the timely and accurate identification of pathogens in the clinic is required to initiate precise and individualized treatment. Metagenomic next-generation sequencing (mNGS) has been a useful supplement to routine culture method for the etiological diagnosis of DFUs. In this study, we utilized a routine culture method and mNGS to analyze the same DFU wound samples and the results were compared.MethodsForty samples from patients with DFUs at a tertiary medical center in South China were collected, the microorganisms were identified with mNGS and routine culture method simultaneously.ResultsThe results showed that the positive detection rate of microorganisms in DFUs with mNGS was much higher (95% vs. 60%). Thirteen strains of microorganisms were detected with routine culture method, and seventy-seven strains were detected with mNGS. Staphylococcus aureus was the most common microorganism detected with culture method, while Enterococcus faecalis was the most common microorganism detected with mNGS. The false negative rate of the culture method was 35%, that was, 14 samples with negative results with culture method were found to be positive with mNGS.ConclusionThe mNGS method had a higher positive detection rate and identified a broader spectrum of microorganisms in DFUs, thus, mNGS provided a more comprehensive understanding of the microbiome of DFUs to facilitate the development of timely and optimal treatment.Trial registrationThe study was conducted in accordance with the Declaration of Helsinki and approved by the Ethical Review Committee of the Fujian Medical University Union Hospital (approval number 2021KY054).

Development of a TaqMan-based dosage analysis PCR assay for the molecular diagnosis of 22q11.2 deletion syndrome.

A 1.5 to 3 Mb microdeletion of chromosome 22q11.2 with loss of multiple genes including histone cell cycle regulator (HIRA) causes 22q11.2 deletion syndrome (22q11.2 DS), a common disorder with variable manifestations including congenital malformations affecting the heart, palate and kidneys in association with neurodevelopmental, psychiatric, endocrine and autoimmune abnormalities. The aim of this study was to develop a TaqMan based dosage analysis PCR (TaqMan qPCR) for use as a rapid, cost-effective test for clinically suspected patients fulfilling previously described criteria for molecular diagnosis of 22q11.2 DS in a lower middle-income country where the cost of testing limits its use in routine clinical practice. Nineteen patients were recruited with informed consent following ethical approval from the Ethics Review Committee (ERC), Lady Ridgway hospital, Colombo. Dosage analysis of extracted DNA was performed using a TaqMan qPCR assay by amplifying regions within the target (HIRA) and control [Testin LIM domain protein (TES)] genes of a suspected patient (P) and unaffected person (N). For detection of a deletion, the normalized values (HIRA / TES dosage) of a patient were compared with normalized values of an unaffected person. A ratio of P:N of 0.5 confirmed presence of a deletion while a ratio of 1.0 refuted this. Seven of 19 (37%) cases were confirmed to have a HIRA deletion, confirming the diagnosis of 22q11.2 DS, with these results being in complete agreement with those of fluorescence in-situ hybridization (FISH), (performed in 9/19 (47.3%) of recruited cases) and whole exome sequencing (WES) (all 19 samples tested). This TaqMan qPCR assay was able to reliably distinguish HIRA deleted cases from the non-deleted ones. The assay was both less expensive and faster compared to commercially available alternatives in our setting, including FISH and multiple ligation-dependent probe amplification (MLPA).

Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden

IntroductionPremenstrual dysphoric disorder (PMDD) is a cyclic mood disorder affecting around 2%–5% of women of reproductive age. Pharmacological interventions exist, but many patients with PMDD experience residual symptoms, discontinue medications...

Identification of novel RIPK4 variants in a Chinese patient with Arthrogryposis Multiplex Congenita (AMC)

BackgroundArthrogryposis multiplex congenita (AMC) is a congenital disorder characterized by multiple joint involvement, primarily affecting limb mobility and leading to various tissue contractures. Variations in the RIPK4 gene may impact connective tissues, thereby resulting in a spectrum of malformations. This study aimed to identify the genetic etiologies of AMC patients and provide genetic testing information for further diagnosis and treatment of AMC.MethodsWe recruited a Chinese female patient with hand-related AMC and her family members. Whole-exome sequencing (WES) was employed to determine the genetic etiologies of the patient’s disease. The pathogenic mechanisms of the identified variations were analyzed using protein tolerance profiling and modeling.ResultsWe identified two novel RIPK4 variants (c.1354G > A, p.E452K; c.1558A > T, p.T520S). Pathogenicity studies indicated that the c.1354G > A, p.E452K variant changed the charge from negative to positive and altered the chemical properties from acidic to alkaline, potentially significantly affecting protein function.ConclusionsWe reported the discovery of two novel RIPK4 variants (c.1354G > A, p.E452K; c.1558A > T, p.T520S) in a Chinese AMC female patient’s family. Our study enhances the genetic repository for AMC and highlights the pathogenicity of RIPK4 variants, underscoring the significance of comprehensive management for genetic-related diseases, particularly the critical roles of prenatal diagnosis and genetic counseling.Trial registrationThe research protocol received approval from the Ethics Review Committee of Xiangya Hospital of Central South University in China (approval number: 202103427), registered in March 2021, with all participants providing duly signed informed consent forms.

Controlled ovarian hyperstimulation with or without letrozole for fertility preservation in breast cancer patients: study protocol for a randomised controlled trial

IntroductionMultimodal anticancer therapies greatly damage the fertility of breast cancer patients, which raises urgent demand for fertility preservation. The standard options for fertility preservation are oocyte and embryo cryopreservation; both...

Development of a short version of the perceived social support scale: based on classical test theory and ant colony optimization

BackgroundDespite the relatively small number of items on the Perceived Social Support Scale (PSSS-12), there has been a trend toward simplification of the scale in order to minimize testing time. In this situation, some researchers based on the responses of military spouses in the U.S., has simplified the PSSS-12 to develop the PSSS-M6. This study aimed to develop a short version of the PSSS-12 suitable for the Chinese general population.MethodsA multi-stage stratified cluster sampling method was employed to collect data from 10,914 residents in 120 cities across the country. After randomly dividing the data into two parts, exploratory analysis and confirmatory analysis were conducted separately. During the exploratory analysis of dataset 1, the scale was simplified using both Classical Test Theory (CTT) and the Ant Colony Optimization (ACO), resulting in one short form for each approach. Additionally, three short forms were obtained by introducing other short forms of the Multidimensional Scale of Perceived Social Support (MSPSS) scale derived from multidimensional item response theory in previous studies. The reliability and discriminant validity of the three short forms were tested. Subsequently, the reliability, validity, model fit and measurement invariance for the two short forms of the MSPSS scale were examined using dataset 2.ResultsThe 6-item short form developed based on the ACO (PSSS-A6) exhibited the best psychometric properties among all the short forms. Moreover, the 3-item short form composed of items with the highest factor loadings in each dimension also demonstrated good psychometric properties.ConclusionsIn future research, if a short form of the MSPSS scale is needed for measurement purposes, the 3-item short form is suitable for clinical settings, large-scale cross-sectional studies, or longitudinal studies, while the PSSS-A6 is more appropriate for more precise measurements.Trial registrationThis study underwent ethical review (JNUKY-2021-018) by Jinan University.

Tibial tubercle transfer SurgeRy and physiothErapy Versus physIotherapy only for chronic paTellofemorAL paIn: study protocol for a randomiSed controllEd trial (REVITALISE)

BackgroundPatellofemoral pain (PFP) is a common musculoskeletal disorder resulting in anterior knee pain. Physiotherapy is the current standard treatment, while surgical intervention (tibial tubercle transfer [TTT]) is reserved for chronic cases when nonoperative treatment has failed. TTT can result in clinically meaningful improvement in patients with patellofemoral maltracking without instability. However, to date, no randomised controlled trials (RCT) have compared TTT combined with a physiotherapy (PT) programme to PT alone as the initial treatment for PFP.MethodsA single-centre nonblinded RCT in 40 patients with chronic PFP (> 1 year) and tibial tubercle-trochlear groove (TT-TG) > 15 mm will be randomised to either TTT followed by PT or to PT alone in a 1:1 ratio in a concealed manner. The primary outcome is knee pain at 18 weeks for the TTT group (6 weeks splint phase + 12 weeks PT) and at 12 weeks for the PT group, measured by the visual analog scale (VAS). Secondary outcomes include Patient-Reported Outcome Measures (PROMs) using the Kujala score, International Knee Documentation Committee (IKDC) ‘Subjective Knee Form’, Tegner Activity score and EuroQol 5D-5 L for quality of life. Range of motion (ROM) is measured using the decline step-down test (DSDT). Between-group differences will be analysed using multivariable linear regression analysis, while longitudinal differences will be assessed with linear mixed models for repeated measures. The difference in direct medical costs will also be assessed.DiscussionThe REVITALISE study is the first randomised study to compare surgical intervention (TTT) followed by PT to PT alone in patients with chronic PFP. This study will generate level-1 evidence on the most effective treatment for chronic PFP, which can be integrated into the national guideline to aid orthopaedic surgeons and physiotherapists in their decision-making and ultimately improve our care for patients with chronic PFP.Trial registrationStudy Identifier NCT06227806, registered on 26 Jan 2024 on ClinicalTrials.gov. The study underwent independent peer review and received approval from the ethical review board (number NL80956.091.22).

Efficacy of tamsulosin in patients with lower urinary tract symptoms due to benign prostate enlargement and having intravesical prostate protrusion.

Objective: To study the efficacy of Tamsulosin in patients with IPP due to BPE. Study Design: Descriptive study. Setting: Department of Urology, Madinah Teaching Hospital Faisalabad. Period: Oct 2020 to April 2021. Methods: After approval from ethical review comity and informed consent a total of 96 male patients between the ages 50-90 years who had LUTS due to benign prostate enlargement of ≥30g were included in the study. Patients with no IPP or having uncontrolled hypertension / diabetes were excluded from the study as well as those having LUTS due to any other etiology e.g. neurogenic bladder or bladder stone. IPSS was calculated for all the patients and entry was made in the research pro forma. All patients received Cap. Tamsulosin 0.4 mg at bedtime for 2 weeks. On follow up in outpatient department, IPSS was calculated again and any improvement of 3 points of the IPSS score was taken as significant and as an evidence of efficacy of Tamsulosin. All the data including any complication was collected and secured on the pro forma. Results: Pretreatment and post treatment mean IPSS was calculated to be 19.54 ± 5.87 and 17.27 ± 4.29 respectively. Frequency of efficacy of Tamsulosin in patients with Intravesical prostatic protrusion due to benign prostatic enlargement was recorded in 42.71% (n=41) whereas 57.29% (n=55) had no efficacy. Stratification with regards to grade of IPP shows that 12 of 25 cases of grade I, 19 of 40 cases in grade II and 10 of 31 cases in grade III had efficacy, p value was 0.23. Conclusion: We concluded that tamsulosin is effective in patients with intravesical prostatic protrusion due to benign prostatic enlargement, however, further trials are required to validate our results.

Development, Implementation and Initial Evaluation of the Blueprint for MBBS Theory Exams in a Private Medical College of Pakistan

Objective: This study aimed to enhance the validity of the exam bank at Liaquat National Medical College (LNMC), Karachi, through the development and evaluation of the exam blueprinting process as part of an ongoing quality assurance initiative. Study design and setting: This study was conducted at Liaquat National Medical College (LNMC), Karachi. Participants included key stakeholders i. faculty members, ii-officials from the examination department (involved in the development of the fourth-year MBBS neuroscience exam blueprint), and iii-students. Methodology: Ethical approval for this study was taken by the LNMC Ethics Review Committee. For the ease of understanding, this article was divided into two sections: In first section, the stepwise approach of blueprint development was discussed whereas the second section dealt with feedback from 105 Year 4 MBBS students, feedback from faculty involved in this process and lastly, the experiences of examination unit personnel were explored. Results: Following the Calgary model by Coderre et al., blueprint for undergraduate MBBS theory exam was developed. Students (85%) agreed that the exam accurately assessed the taught content. Faculty expressed satisfaction with the blueprinting process, noting improvements in exam quality, topic representation, and the elimination of redundant questions. Examination unit personnel reported better time management and improved alignment with curricular objectives. Initial challenges, such as faculty’s lack of training and resistance were also identified. Conclusion: The blueprinting process significantly enhanced alignment of theory exam with educational objectives thereby ensuring the content validity. Continued training and institutional support are vital to overcoming initial challenges

The relationship of parent-child attachment and religiosity to improving adolescent self-esteem

Adolescence is risky and vulnerable; the emergence of risky behavior is often motivated by low self-esteem. This study aims to analyze the effect of parental attachment and religiosity on the adolescents' self-esteem in Bogor City and the differences in parental attachment, religiosity, and self-esteem between male and female adolescents. This study uses an explanatory research design and aims to explain the cause-and-effect relationship between variables. This research has passed the ethical review of the Human Research Ethics Committee of the Bogor Agricultural University, with Number 1062/IT3.KEPMSM-IPB/SK/2023.The research was conducted in ten schools, namely four junior high schools and six senior high schools in Bogor City. The population of this study was adolescents in Bogor City. The sampling technique in this study was cluster random sampling based on class, involving ten schools with details of four junior high schools and six senior high schools, with 50 students from each school, so the total number of respondents was 500 respondents. The research was conducted in October 2023. Data analysis used Statistical Package for Social Science (SPSS) 25.0 for inferential analysis (independent sample T-Test and Structural Equation Modeling-Partial Least Square (SEM-PLS) for influence analysis. This study shows that adolescent self-esteem is influenced by parent-child attachment and religiosity. The difference in test results showed that religiosity in female adolescents was higher. Meanwhile, male adolescents have higher self-esteem. The implications of this research are the government can expand access to family and adolescent counseling services in schools and the community. This counseling can help families build better attachments, help adolescents find their identity, and improve their self-esteem.

A dialogue on trust in ethics processes for creative practice research education

Purpose Securing ethical approval can be a frustrating and opaque experience for some creative practice research students who may find the processes required of them not well suited to their specific inquiry. This can lead to an erosion of trust between students and their institutions. This paper aims to synthesize perspectives representing both creative practice research supervisors and Institutional Review Boards (IRBs) to develop recommendations for improving processes and supporting creative practice research training. Design/methodology/approach The authors used dialogical inquiry (Wells et al., 2021) to facilitate a dialogue between the authors, who represent different stakeholders in the ethical review process for creative arts research students. Focus topics for the dialogue were developed collaboratively based on existing literature. Findings Based on the dialogue, the authors make the following recommendations: frame ethics as part of project design alongside aims and methodology rather than as project logistics; structure ethics review processes to ensure ongoing engagement between research students and IRBs; and share exemplars and templates as part of research training. Additionally, the authors advocate for the need to create continuing opportunities for dialogue. Originality/value Previous work interrogating ethical review processes for creative practice research has adopted a clear position from either a creative practice researcher or an IRB member perspective. This dialogue facilitates a novel synthesis of these positions, ensuring the recommendations support the objectives of both IRBs and creative practice researchers.

Institutional Theory in Social Entrepreneurship: A Review and Consideration of Ethics

Institutional Theory in Social Entrepreneurship: A Review and Consideration of Ethics