National Research Ethics Committee Research Articles

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

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

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...

Ethics considerations for precision medicine research and genetic testing in low- and middle-income countries.

Genetic data transfer within multicentre clinical trials conducted in low- and middle-income countries is common and must be communicated to study participants as part of ethical requirements. To analyse ethics practices in precision medicine research in low- and middle-income countries and make useful recommendations. We conducted a narrative review of published literature and existing ethics frameworks regarding underrepresentation of low- and middle-income countries in genomic databases, informed consent and data security discussions, as well as the potential for exploitation and limited access to benefits. The findings highlight the need for increased diversity in research participation, robust ethical frameworks, and knowledge sharing between developed and developing countries. The findings show that strengthening national research ethics committees and fostering collaboration can help low- and middle-income countries in addressing unique challenges and harnessing the potential of precision medicine while ensuring ethical conduct and equitable access for all. Our review emphasizes the importance of ethical considerations in precision medicine research to ensure that its benefits reach all affected populations, promoting a more just and more equitable healthcare future. There is a need to ensure that research participants are accorded the rights, whether in the ownership of their samples or the right to know what type of genetic studies have been conducted on their samples. It is important to have binding agreements that will allow clinical trial participants to access drugs that proof effective based on the trials they participated in.

Investigating Father or Partner Involvement in Family Integrated Care in Neonatal Units: Protocol for a Prospective, Multicenter, Multiphase Study

Neonatal unit (NU) admissions for premature babies can last for months, which can significantly impact parental mental health (MH) with symptoms of depression, stress, and anxiety. Literature suggests fathers experience comparable MH symptoms to mothers. Family integrated care (FICare) is a culture where parents are collaborators and partners in caring for their hospitalized newborns. FICare improves infant outcomes and maternal MH. Similar reports on fathers are limited. The primary aim of this study is to investigate the impact of supporting father or partner engagement in FICare of preterm infants on their MH up to 6 weeks postdischarge. The secondary aim is to investigate the impact on maternal MH. This is a 2-phase study: phase 1 to gather baseline information and phase 2 to assess the impact of enhanced father or partner engagement in FICare on their MH, involving 2 NUs (tertiary and level 2). Enhanced FICare will be developed and introduced (eg, information booklet, workbook, classes, and a father peer-support group) alongside standard FICare practices. Father or partner MH will be assessed with semistructured qualitative interviews and validated questionnaires: Generalized Anxiety Disorder Assessment, Patient Health Questionnaire, and Parental Stressor Scale: Neonatal Intensive Care Unit from NU admission to 6 weeks postdischarge. Mothers will be assessed by focus groups and the same questionnaires. Descriptive statistics and appropriate comparative tests, such as the 2-tailed t test, will be used to analyze and compare phase 1 and 2 data. Qualitative data will be coded line by line with the use of NVivo (Lumivero) and thematically analyzed. Simultaneously, systematic reviews (SRs) of fathers' experiences of FICare and their MH outcomes will be conducted. The study was approved by the National Research Ethics Committee (22/EM/0140) in August 2022. A parent advisory group was formed to advise on the study methodology, materials, involvement of participant parents, and dissemination of study findings. A recent SR demonstrated that data saturation is likely to be achieved by interviewing 9 to 17 participants. We will study a maximum of 20 parents of infants born at less than 33 weeks' gestation in each phase. As of October 2023, the study was ongoing. The SR studies are registered with the PROSPERO database (324275 and 306760). The projected end date for data collection is July 2024; data analysis will be conducted in November 2024 and publication will occur in 2025. The study aims to demonstrate the feasibility of using a father or partner-sensitive FICare model for parents of premature babies with a positive impact on their MH. It will demonstrate the feasibility of providing FICare to extremely premature babies receiving intensive care. This study may support the development of inclusive FICare guidelines for nonbirthing parents and their extremely premature infants. ClinicalTrials.gov: NCT06022991; https://classic.clinicaltrials.gov/ct2/show/NCT06022991. DERR1-10.2196/53160.

Evaluation of a Training Program on Gender Mainstreaming in Health Research Evaluation at the Senegalese National Research Ethics Committee.

Health research must be of high ethical and scientific quality and consider the needs and experiences of women, men, and nonbinary individuals. National Research Ethics Committees (RECs) are in a strategic position to impede sex- and gender-blind research. In 2020 and 2021, training programs on gender mainstreaming and sex and gender approaches in research evaluation were launched in Senegal. They were evaluated through a mixture of qualitative and quantitative methods. Knowledge acquisition was 16.67%, 8.54%, and 28.42% for the trainees of 2021, 2020, and those who attended the training in both years, respectively. Gender mainstreaming was reported as pertinent in research ethics by 74% of participants. This training is expected to catalyze gender-transformative research ethics in West Africa.

Defining the hidden burden of disease in rural communities in Bangladesh, Cambodia and Thailand: a cross-sectional household health survey protocol

IntroductionIn low-income and middle-income countries in Southeast Asia, the burden of diseases among rural population remains poorly understood, posing a challenge for effective healthcare prioritisation and resource allocation. Addressing this...

Chapitre 2. L’autonomisation des comités nationaux d’éthique de la recherche en Afrique : perspective historique et enjeux actuels

Since the 60s, and particularly after various scandals in the 90s, national research ethics committees in Africa have established themselves as key players in the field of international clinical research. Notably based on the principle of double ethical review, their existence has historically been aimed at preventing a form of ethical dumping, a temptation that still exists today on the part of some research promoters. While the international framework of “soft” law has favored their emergence and legitimacy, a legal and regulatory framework of “hard” law is also necessary at local level for each national research ethics committee, to ensure its proper functioning and the optimal fulfillment of its missions. The aim of this article is to analyze the similarities and differences between three national ethics committees in Africa, specifically the CNERS of Guinea, the CNERS of Benin and the CNESVS of Côte d’Ivoire, in terms of status, missions, legal or regulatory ground and, more generally, autonomy. This analysis will enable us, on the one hand, to take account of common logistical difficulties and, on the other, to go beyond differences in legal status and missions to define what enables this type of committee to fully exercise its role(s). Finally, this article proposes to model the various elements that contribute to the autonomy and resilience of a national research ethics committee, around a notion proposed on this occasion: the “circles of autonomy”.

Latin American Cerebral Palsy Register (LATAM-CPR): study protocol to develop a collaborative register with surveillance of children with cerebral palsy in Latin American countries

IntroductionCerebral palsy (CP) is one of the leading causes of childhood disability globally with a high burden in low-income and middle-income countries (LMICs). Preliminary findings from the global LMIC CP...

Survival Analysis of Adults with Acute Lymphoblastic Leukemia in Ecuador

Background Acute lymphoblastic leukemia (ALL) is the second most common acute leukemia in adults. Unfortunately, in Ecuador there are no survival studies in patients ≥15 years with ALL, thus, this is the first national report. The aim of the study was to describe clinical-demographic characteristics and overall survival (OS). Methods Medical records of 628 patients from 8 reference hospitals in Ecuador with acute lymphoblastic leukemia (ALL) aged ≥15 years, diagnosed between January/2015 and December/2022, were retrospectively reviewed. A high-risk group was defined as: age ≥ 35 years ; ≥ 30,000/mm3 leukocytes in B-cell acute lymphoblastic leukemia (B-ALL) or ≥ 100,000/mm3 leukocytes in T-cell acute lymphoblastic leukemia (ALL- T) ; CNS infiltration at diagnosis, and/or if EMR was not reached (<0.01%) negative at the end of induction. If none of these factors were present, it was classified as standard risk. OS and treatment-related mortality were evaluated. Before carrying out this study, the approval of a national research ethics committee was obtained, as well as the approval of the 8 participating centers. Results 628 patients with ALL were included in the study. Summary of clinical and demographic data Table 1. In this cohort of patients, 9 different regimens of intensive chemotherapy were used. 454/517 (87.8%) patients with B-ALL were considered high risk. 595/628 (94.5%) patients received intensive chemotherapy. 150/595 (25.2%) and 54/595 (9.0%) patients died during the induction and consolidation phase respectively, reaching a mortality related to the treatment of 34.2%. In 290/401 (72.3%) with B-ALL achieved a complete response (CR) after induction, also 199/401 (49.1%) patients achieved minimal residual disease (MRD) negative (<0.01%). 16/235 (6.8%) patients with B-ALL considered high risk who achieved CR received allogeneic hematopoietic stem cell transplantation (HSCT). 32/35 (91.4%) patients with T-cell acute lymphoblastic leukemia (T-ALL) received intensive chemotherapy, of which 17/24 (70.8%) achieved CR, MRD negative (<0.01%), in 8/20 (40.0%) and 3/17 (17.6%) who achieved CR received HCT. The median OS was 12 months (95% CI 9.8-14.1) with a 5-year OS of 25.6%. The median OS for intensive chemotherapy patients with B-ALL was 12 months (95% CI 9.8 - 14.1) with a 5-year OS of 25.8% and 8 months (95% CI 5.9 - 10.0) with a 5-year OS of 23.5% for T-ALL. The 5-year OS for patients with HSCT was 78.4% (median survival not reached). The median OS for patients with B-ALL who received intensive high-risk chemotherapy was 12 months (95% CI 9.7-14.2) while median survival was not reached in the standard-risk group (p=<0.01). Figure 1. In patients with ALL-B, regimens with or without L-asparaginase achieved a 5-year OS of 26.4% vs 22.9% (p=0.588), respectively. In multivariate analysis for patients with ALL-B on intensive chemotherapy, age [HR 1.02 (95% CI 1.00 - 1.04) p=0.014] was significantly associated with OS, as well as those patients who did not achieve negative an MRD [HR 1.82 (95% CI 1.23-2.69) p=<0.01]. Otherwise, the adolescent and young adults (AYA) group, BCR:ABL fusion, CNS infiltration and leukocyte number at debut, L-asparaginase chemotherapy regimens, and being classified as high-risk group did not show statistical differences associated with OS . Conclusion The reported OS rates in this cohort are considerably low when compared to with international available data, being mainly negatively affected by the high treatment-related mortality rate, and the small number of patients who reach a HSCT.

The left main coronary artery (LMCA) physiology study: comprehensive clinical haemodynamic evaluation of physiology and pathophysiology

Abstract Background & Purpose At present, physiological evaluation of left main coronary artery (LMCA) disease is based on the assumption that pressure-based indices are agnostic to the vessel being assessed. We conducted mechanistic studies to determine whether pressure-based indices in the left anterior descending (LAD) and left circumflex (LCx) arteries are different and if so, the basis of this discrepancy, in patients with normal coronary arteries (LMCA Physiology Study) and in those with isolated LMCA disease (LMCA Pathophysiology Study). Methods Patients with exertional angina were prospectively enrolled after baseline investigation of computed tomography or invasive angiography and those with left ventricular impairment were excluded. Eligibility for the Physiology Study required the absence of epicardial disease on angiography and/or fractional flow reserve or significant coronary microvascular disease (LAD coronary flow reserve (CFR) <2.0). Simultaneous intracoronary pressure and Doppler measurements were performed in the LAD and LCx arteries, at rest and adenosine mediated hyperaemia. A subset also underwent 3-Tesla quantitative stress perfusion cardiac magnetic resonance imaging. Eligibility for the Pathophysiology Study required isolated LMCA disease, which was verified physiologically by pressure wire pullback according to predefined criteria of 1) ≥80% of total FFR arising from the left main coronary artery disease and 2) ≤0.05 FFR gradient distal to the left main coronary artery disease in both vessels. A paired 2-tailed test for significance was performed for all analyses. The protocols were approved by the UK National research ethics committee. Results 71 patients were prospectively enrolled, 28 in the Physiology Study and 43 in the Pathophysiology Study (Table 1). In the LMCA Physiology Study, CFR was higher and hyperaemic microvascular resistance (hMR) lower in the LAD compared to the LCx. In the LMCA Pathophysiology Study, the contribution to total FFR of downstream disease was negligible and comparable in both branches. Moreover, hyperaemic, and non-hyperaemic pressure-based indices were all significantly lower in the LAD, compared to the LCx. In addition, CFR was higher and hMR lower in the LAD compared to the LCx. Correlations are outlined in Figure 1. Differences in pressure-derived measurements remained after correction for the influence of hydrostatic pressures. However, when adjusted for subtended myocardial mass, there was no significant difference in invasive hemodynamic indices or quantitative perfusion analysis-derived myocardial perfusion reserve index. Conclusions Commonly used indices of stenosis severity are not agnostic to the vessel assessed due to differences in myocardial mass and microvascular resistances. The need for vessel-specific thresholds has significant implications on LMCA disease assessment and potentially, interpretation of the existing evidence base on physiological assessment of non-LMCA disease.Table 1Figure 1

Epigallocatechin-3-Gallate (EGCG) Ameliorates Ineffective Hematopoiesis of Myelodysplasia Syndrome (MDS)

Epigallocatechin-3-gallate (EGCG) is a gallate ester obtained by condensation of gallic acid with the (3R)-hydroxy group of (-)-epigallocatechin, extracted from green tea, exhibiting beneficial effects as an apoptosis and cell differentiation inducer helping counteract uncontrolled proliferation and impaired differentiation characteristic of leukemia and myelodysplastic syndrome. Clinical trials in patients with chronic lymphoid leukemia, low grade B-lymphomas and acute myeloid leukemia with myelodysplasia related changes were carried out showing positive results. This study aimed to evaluate the in vivo effect of EGCG in a mice model of myelodysplastic syndrome (NHD13 mice). B6.SJL-PtprcaPep3b/BoyJ mice (PepBoy) received 9,5Gy irradiation followed by transplantation of bone marrow cells from NUP98-HOXD13 mice by i.v. caudal vein injection; disease establishment was confirmed at day 15 by blood cytopenia. To assess the EGCG effects on MDS, 10-week-old female NUP98-HOXD13 mice (NHD13 +) and their littermate WT mice (NHD13 -) were treated for 4 weeks with EGCG (50mg/Kg/day 5x/week i.p.) or vehicle. The animals were then sacrificed, and bone marrow and spleen were obtained for flow cytometry and histology analyses. Automated hematological counts and clinical biochemistry parameter analysis were done. After signing the written informed consent, a 71-year-old man diagnosed with high-risk MDS, with 9% blasts in the bone marrow, underwent a daily oral 800mg EGCG treatment. This study was approved by the Ethical Committee of University of Campinas and by the National Research Ethics Committee ( CAAE: 40656720.5.0000.5404). During this period, the patient underwent weekly clinical assessments and laboratory studies to monitor any potential toxicity. Peripheral blood samples were obtained before and after treatment to observe any alteration in cell counts and immune cell composition. Before treatment, NDH13 + exhibited a reduction in number of leukocytes, platelets, and hemoglobin levels, in accordance with the literature. EGCG treatment ameliorated hematological parameters, showed by increased leukocyte numbers (monocytes and neutrophils) and platelets with no signals of liver and kidney toxicity detected by histology and serum biochemistry. Untreated mice showed increased osteoprogenitor, osteoblast and endothelial cells in the bone marrow, corroborating the literature. EGCG treatment did not alter the frequency of these cells, HSC or immature cells (CD34 + or CD117 +). However, EGCG induced extramedullary hematopoiesis in spleen and no changes in the percentage/frequency of Foxp3 + regulatory T cells (CD4 +CD25 + and/or CD4 +FOXP3 +). Additionally, the patient treated by ECGC for one month exhibited reduction of regulatory T cells CD4 +CD25 + and CD4 +FOXP3 +, and increased CD8 + T cells (CD3 +CD8 +) and natural killer cells (CD16 +CD56 +) accompanied by increased mature leukocytes (monocytes and neutrophils), with no changes in hemoglobin and platelet number. Our initial findings indicate that EGCG induces improved hematological parameters in MDS and might shift immune cells to a more cytotoxic phenotype. The extramedullary hematopoiesis observed in mice may be due to reduction of CXCR4 in bone marrow cells, as previously described by our group. In summary, EGCG might be a promising adjuvant in the treatment of MDS. Further research and clinical studies are warranted to validate and fully explore EGCG therapeutic benefits. Fig1a EGCG ameliorates NHD13 and transplanted mice hematological parameters. At the end of the EGCG treatment (50mg/kg/day i.p) or vehicle (Ctrl), NHD13 + and transplanted (PepBoy) mice were bled from the retro-orbital plexus. EGCG induced an increased the number of leukocytes ( A), monocytes ( B), neutrophils ( C) and the number of platelets ( D) using the CELL-DYN Emerald Hematology System counter. EGCG represented by the green column, and the vehicle by the gray color. Statistical significance ( Mann-Whitney test) is indicated; n=6 per group. Fig1b. EGCG improved the immune system of HR-SMD patient. A 71-years-old man with HR-SMD received EGCG treatment (800 mg/Kg/day) for 30 days. Peripheral blood counts were evaluated at day 0 and day 30. EGCG ameliorated hematological parameters - increased mature leukocytes (A) - monocytes (B) and neutrophils (C), with no changes in hemoglobin (D) and platelets

Mixed-methods study protocol to identify expectations of people with type 1 diabetes and their caregivers about voice-based digital health solutions to support the management of diabetes distress: the PsyVoice study

IntroductionType 1 diabetes (T1D) requires continuous management to obtain a good metabolic control and prevent acute complications. This often affects psychological well-being. People with T1D frequently report diabetes distress (DD)....

Co-Design of a Voice-Based Digital Health Solution to Monitor Persisting Symptoms Related to COVID-19 (UpcomingVoice Study): Protocol for a Mixed Methods Study.

Between 10% and 20% of people with a COVID-19 infection will develop the so-called long COVID syndrome, which is characterized by fluctuating symptoms. Long COVID has a high impact on the quality of life of affected people, who often feel abandoned by the health care system and are demanding new tools to help them manage their symptoms. New digital monitoring solutions could allow them to visualize the evolution of their symptoms and could be tools to communicate with health care professionals (HCPs). The use of voice and vocal biomarkers could facilitate the accurate and objective monitoring of persisting and fluctuating symptoms. However, to assess the needs and ensure acceptance of this innovative approach by its potential users-people with persisting COVID-19-related symptoms, with or without a long COVID diagnosis, and HCPs involved in long COVID care-it is crucial to include them in the entire development process. In the UpcomingVoice study, we aimed to define the most relevant aspects of daily life that people with long COVID would like to be improved, assess how the use of voice and vocal biomarkers could be a potential solution to help them, and determine the general specifications and specific items of a digital health solution to monitor long COVID symptoms using vocal biomarkers with its end users. UpcomingVoice is a cross-sectional mixed methods study and consists of a quantitative web-based survey followed by a qualitative phase based on semistructured individual interviews and focus groups. People with long COVID and HCPs in charge of patients with long COVID will be invited to participate in this fully web-based study. The quantitative data collected from the survey will be analyzed using descriptive statistics. Qualitative data from the individual interviews and the focus groups will be transcribed and analyzed using a thematic analysis approach. The study was approved by the National Research Ethics Committee of Luxembourg (number 202208/04) in August 2022 and started in October 2022 with the launch of the web-based survey. Data collection will be completed in September 2023, and the results will be published in 2024. This mixed methods study will identify the needs of people affected by long COVID in their daily lives and describe the main symptoms or problems that would need to be monitored and improved. We will determine how using voice and vocal biomarkers could meet these needs and codevelop a tailored voice-based digital health solution with its future end users. This project will contribute to improving the quality of life and care of people with long COVID. The potential transferability to other diseases will be explored, which will contribute to the deployment of vocal biomarkers in general. ClinicalTrials.gov NCT05546918; https://clinicaltrials.gov/ct2/show/NCT05546918. DERR1-10.2196/46103.

Simplified sewerage to prevent urban leptospirosis transmission: a cluster non-randomised controlled trial protocol in disadvantaged urban communities of Salvador, Brazil

IntroductionLeptospirosis is a globally distributed zoonotic and environmentally mediated disease that has emerged as a major health problem in urban slums in developing countries. Its aetiological agent is bacteria of...

O042 Enzymatic conversion of human blood group A kidneys to universal blood group O

Abstract Introduction The ABO blood group restriction on allocation of donor organs leads to waiting time disadvantages for individuals of more restrictive blood types. Here, we outline the first preclinical use of two enzymes from Flavonifractor plautii to convert human blood group A kidneys to universal blood group O. Methods Six pairs of human kidneys rejected for transplantation and offered for research were used to in this study with approval from the National Research Ethics committee and Research and Development Office (NRES: 15/NE/0408). Three pairs were perfused for 6 h using normothermic machine perfusion (NMP), and three pairs were perfused for 24 h using hypothermic machine perfusion (HMP), with one kidney per pair randomised to enzyme treatment. Cortical biopsies collected throughout perfusion were examined for antigen loss using immunofluorescence microscopy. Results After 2hrs of NMP, a significant loss of 83.4±10.2% blood group A antigen expression was observed compared to pre-treatment levels (p=0.012), while no significant changes were observed in control kidneys (p=0.999). For HMP, a maximal loss of 71.2±21.9% was observed after 6 h (p=0.066), with no decrease observed in the contralateral controls (p=0.977). Haemodynamic perfusion parameters were stable in both cohorts, with no significant difference between control vs treated kidneys. Conclusion Our results show a loss of 70-80% of blood group A antigens in as little as 2 h of NMP and 6 h of HMP. These approaches pave the way for the first clinical studies that could herald the start of a new era that transforms donor organ allocation in kidney transplantation.

Primary healthcare needs and service utilisation of people with disability: a data linkage protocol

IntroductionGeneral practitioners (GPs) play a crucial role in the early management and treatment of the comorbidities and complications experienced by people with disability. However, GPs experience multiple constraints, including limited...

Comparing biparametric to multiparametric MRI in the diagnosis of clinically significant prostate cancer in biopsy-naive men (PRIME): a prospective, international, multicentre, non-inferiority within-patient, diagnostic yield trial protocol

IntroductionProstate MRI is a well-established tool for the diagnostic work-up for men with suspected prostate cancer (PCa). Current recommendations advocate the use of multiparametric MRI (mpMRI), which is composed of...

What school nurses receive for themselves that influences their remaining in practice: A qualitative study

BackgroundPrevious research indicates a link between what nurses receive for themselves and their remaining in practice. In Norway, school nurses tend to remain in practice, but what it is they receive for themselves has been scarcely studied. The aim of this study, therefore, was to describe and interpret what it is school nurses receive for themselves that influences their remaining in practice.MethodThe study has a qualitative design with a hermeneutic approach. Data were collected through individual interviews on two separate occasions with 15 Norwegian school nurses. The data were analysed using a phenomenological hermeneutic method.ResultsTwo themes demonstrate what it is the school nurses receive for themselves: (1) ‘Gaining interesting workdays for yourself’ and (2) ‘Attaining pleasure for yourself’. Each theme has two sub-themes. The first theme involved the school nurses ‘having an attractive scope of practice’ and ‘having varied tasks’. The second theme involved ‘being trusted’ and ‘being given a response’. The study themes can be comprehensively understood as an expression of what the school nurses identify as the main locus of the good work-life. The school nurses’ remaining seems to revolve around what it is they receive on their own behalf: an affirmation for their ordinary life and what they do as a nurse.ConclusionThis study highlights that what school nurses receive on their own behalf may influence their remaining in practice. It adds to previous research with a more specific understanding of nurses remaining in practice by stating that in identifying the main locus of the good work-life, the school nurses received affirmation for their ordinary life and what they do as a nurse. Thus, it is important that nurses identify the main locus of a good work-life for themselves, as receiving affirmation for what they do in their ordinary workdays may influence their remaining in practice.Registration of clinical trial and registration identification numberThe study was approved by the Norwegian Centre for Research Data (project 59195). National Research Ethics Committee approval was not required, as the study only involved health professionals and did not ask for sensitive information.

Murru Minya–informing the development of practical recommendations to support ethical conduct in Aboriginal and Torres Strait Islander health research: a protocol for a national mixed-methods study

IntroductionConducting ethical and high-quality health research is crucial for informing public health policy and service delivery to reduce the high and inequitable burden of disease experienced by Aboriginal and Torres...

FACTORS INFLUENCING TURN-AROUND TIME OF ETHICS REVIEW IN TANZANIA: ASSESSMENT OF PROTOCOL REVIEW SYSTEMS

Ethics review of health research protocols is paramount for the protection of the rights, safety, and welfare of research participants. The review of protocols is done by designated committees called Research Ethics Committees (RECs). In Tanzania, the National Research Ethics Committee (NatHREC) processes a large volume of protocols every year. Although the turnaround time of ethics review has been identified as a concern for stakeholders involved in the review process, there is a lack of comprehensive research on the specific factors that influence the duration of the review process by examining the research protocols themselves. While the long review timelines have significant implications for the timely commencement of research activities, as well as questions regarding the capacity of research ethics committees (RECs), the existing literature does not adequately address this aspect. The study aimed to assess the factors that influenced the turnaround time of ethics review at the National Health Research Ethics Committee (NatHREC) for research protocols submitted between January 2018 and August 2019. This specific time frame was chosen to capture a substantial sample of protocols and provide a comprehensive understanding of the factors affecting the review process during that period and also because during this period the REC employed two different review systems for protocol review. Several factors were identified as influencing the turnaround time of the ethics review process. Firstly, the review systems played a significant role as during the study period, the REC employed two different review systems; Precursor Protocol Review System (PPRs) and Improved Protocol Review System (IPRs) which proved to be more time-efficient. Secondly, the type of study being reviewed also had an influence on turnaround time as clinical trials had a longer review turnaround time than non-clinical trials. Additionally, the time taken for researchers to resubmit their protocols for review affected the overall turnaround time. If researchers took longer to make necessary revisions, it would naturally extend the review process. By focusing on the NatHREC, which is a prominent and nationally recognized research ethics committee, the study aimed to explore the factors that are influential within a well-established and reputable review system. Understanding the specific factors that contribute to the turnaround time at this committee would provide valuable insights for other similar committees and research ethics bodies across the country. Overall, the study highlighted the importance of addressing factors that influence the turnaround time of the review process to improve the efficiency of the process. The findings suggest that implementing the IPRS can significantly reduce the time taken for ethics review, benefiting both researchers and research participants.