Biomedical Research Ethics Research Articles

Exploratory Qualitative Study to Investigate Factors Influencing Men’s Utilization of Sexual and Reproductive Health Services in Kwa-Zulu Natal

Sexual and reproductive health (SRH) is essential for men’s health, but a large body of research has indicated that the underutilization of most SRH services by men is a persistent issue that needs to be addressed. Men’s reluctance to access sexual and reproductive health services is one of the factors that leads to high morbidity and mortality rates among men, although their diseases may have been prevented or cured. This study aimed to explore factors that influence the decision of men who resided in men’s hostels and who accessed urology clinics in KwaZulu-Natal to seek help for their sexual and reproductive health issues. An exploratory qualitative approach was adopted using focus group discussions. We interviewed seventy-two men of ages above 15 years. The data were analyzed thematically. The Biomedical Research Ethics Committee (BREC) of UKZN granted ethical clearance (BE 347/19). Of the 72 interviewed men, thirty-three men attended urology clinics in the selected hospitals, and thirty-nine men resided in the hostels around Durban in KZN. Seven themes (lack of awareness of SRH services; participants’ reluctance to access SRH services; influence of culture and religion; lack of financial resources; influence of relationship dynamics; perceived low risk of individual sexual behaviors; and healthcare factors that discourage men from accessing SRH services) emerged from the data that were identified as barriers to SRH service utilization by men, whilst three themes (healthcare enabling factors; access to general information on SRH services; and personal motivational factors) emerged as factors that encouraged the participants to access these services. The participants’ reluctance to access SRH services was attributed to the lack of awareness of available SRH services, the influence of culture and religion, lack of financial resources, relationship dynamics, the perceived low risk of sexual behaviors for individuals, and healthcare workers’ negative attitude towards men requiring SRH services. The availability of healthcare resources, the appointment of more male healthcare workers, and more positive attitudes among healthcare workers will encourage men to utilize SRH services. The exposure of various barriers to SRH service utilization by this investigation warrants urgent attention from the government to impart knowledge about this phenomenon to men.

Integrated Whole-Life Cycle Accuracy Valvular Heart Disease Epidemiology Cohort Study (iWAVE): protocol for a prospective cohort study

IntroductionDespite the rapid advancements in cardiovascular surgery in China, the prevalence of valvular heart disease (VHD) continues to rise, particularly among the elderly population. In the resource-constrained western regions, the...

Application of ICU electronic diary platform based on co-design concept in Chinese critically ill patients: a mixed methods study protocol.

Critically ill patients are at a heightened risk for post-traumatic stress disorder (PTSD). While the intensive care unit (ICU) diary has been shown to improve the mental health and quality of life of ICU patients, the handwritten version still has some limitations such as a lack of support for multimedia content and writing by remote family members, as well as being time-consuming and labour-intensive. We hypothesise that constructing an ICU electronic diary platform based on a co-design approach and verifying its applicability could alleviate these limitations, making the ICU diary more convenient for users. This sequential exploratory mixed-methods study will consist of four consecutive phases: understanding the ICU diary research content and implementation, developing an ICU electronic diary platform after conducting qualitative interviews with stakeholders, verifying the applicability of the platform and verifying its effectiveness. Ethics approval was obtained from the Biomedical Research Ethics Committee of the Affiliated Hospital of Zunyi Medical University (approval number: KLL-2023-602). The results of this study will be distributed through peer-reviewed journals. Chinese Clinical Trial Register (ChiCTR2400079903).

Comparison of side-hole and step-tip catheters for patients requiring continuous renal replacement therapy in intensive care units: study protocol for a randomised controlled trial

IntroductionIn addition to various techniques involved in catheter insertion, catheter placement location, lumen diameter and operation and management during continuous renal replacement therapy (CRRT), the design of the tip and...

Mental Health Effects of COVID-19 Among Health Care Providers: A Case Study of Kalulushi General Hospital in Kalulushi District, Zambia

Coronavirus disease 2019 is an infectious disease which was first identified in Wuhan a City in the Peoples Republic of China in December 2019. The aim of this study was to establish the mental health effects of COVID 19 on the frontline health care providers at Kalulushi General Hospital in Kalulushi district of Zambia. A descriptive cross-sectional study was employed to assess the mental health effects of COVID 19 on the frontline health care providers at Kalulushi General Hospital in Zambia. The study used simple random sampling technique to select 122 respondents to participate in the study. Data was collected from study participants using structured questionnaire. The collected data was analyzed using SPSS version 25 and MS excel and was presented using tables, bar charts and pie charts. Multivariate logistic regression analysis was used to examine the relationships between socio-demographic characteristics and mental health effects of COVID-19 parameters. The ethical approval was gotten from Lusaka Apex Medical University Biomedical Research Ethics Committee, Kalulushi General Hospital and Kalulushi District Health Office respectively. The study revealed that, most of the respondents (31%) were afraid of contracting COVID-19, while 27% of study participants claimed that COVID 19 was a propaganda and that no one knew when it would end. The study also found that, a small proportion of study participants reported a decline in work morale (17%), likely associated with witnessing numerous deaths (19%) and the added stress of inadequate personal protective equipment (PPE) experienced by 15%. The study further demonstrated that 58% of the respondents accepted that working in a COVID-19 environment affected their mental health while 42% of the respondents did not accept that working in the COVID-19 environment did affect mental health of frontline healthcare providers. The study further revealed that, most of the respondents were using handwashing or sanitizers, facemasks and protective clothing (27%) to cope with COVID-19 pandemic. The study also showed that, a few respondents were practicing social distancing (22%), and having healthy diet (19%) in order to cope with COVID-19. Marital status and religion were found to have significant association with copying strategies of frontline healthcare providers against COVID-19 pandemic at Kalulushi General Hospital in Kalulushi District of Zambia (P < 0.05). WHO, CDC, and Zambian Ministry of Health should prioritize implementing Critical Incident Stress Management protocols, develop culturally sensitive mobile applications to offer self-guided interventions, and promote healthy coping mechanisms among frontline healthcare providers.

HIV-1 subtype-specific drug resistance on dolutegravir-based antiretroviral therapy: protocol for a multicentre study (DTG RESIST)

IntroductionHIV drug resistance poses a challenge to the United Nation’s goal of ending the HIV/AIDS epidemic. The integrase strand transfer inhibitor (InSTI) dolutegravir, which has a higher resistance barrier, was...

American registry of ambulatory and acute decompensated heart failure (AMERICCAASS registry): Rationale and design.

Heart failure (HF) is a highly prevalent and progressive condition associated with significant morbidity and mortality rates. Acute decompensated HF precipitates millions of hospitalizations each year. Despite therapeutic advances, the overall prognosis of HF is poor. The varying clinical courses and outcomes of patients with this disease may be due to region-specific gaps and since most HF studies are conducted in developed countries, the participation of Latin American and Caribbean countries is low. Considering this, the American Registry of Ambulatory and Acute Decompensated Heart Failure (AMERICCAASS) aims to characterize the population with ambulatory and acute decompensated HF in the American continent and to determine rehospitalization and survival outcomes during the 12months of follow-up. AMERICCAASS Registry is an observational, prospective, and hospital-based registry recruiting patients with ambulatory or acute decompensated HF. The registry plans to include between two and four institutions per country from at least 20 countries in the Americas, and at least 60 patients recruited from each participant institution regardless of their ambulatory or acutely decompensated condition. Ambulatory patients with confirmed HF diagnosis or inpatients presenting with acute decompensated HF will be included. Follow-up will be performed at 12months in ambulatory patients or 1, 6, and 12months after hospital discharge in acutely decompensated HF patients. This ongoing study began on 1 April 2022, with recruitment scheduled to end on 30 November 2023, and follow-up on 31 January 2025. Ethics approval was obtained from the Biomedical Research Ethics Committee of Fundación Valle del Lili. Data collected in the AMERICCAASS registry is being stored on the electronic platform REDCap (Research Electronic Data Capture), which allows different forms for patient groups to enable unbiased analyses. For quantitative variables comparison, we will use the Student's t-test or non-parametric tests accordingly. Categorical variables will be presented as proportions, and groups will be compared with Fisher's exact test. The significance level will be <0.05 for comparisons. Readmissions and post-discharge mortality will be calculated as proportions at 1, 6, and 12months, with a survival analysis by conditional probability and the Kaplan-Meier method. AMERICCAASS Registry is intended to be the most important registry of the continent for obtaining important information about demographics, aetiology, co-morbidities, and treatment received, either ambulatory or hospitalized. This registry may contribute to the optimization of national and regional evidence and public policies for the diagnosis and treatment of HF disease.

International scope of biomedical research ethics review.

Many countries consider long-term implications for society.

Mapping Evidence in Teaching Palliative Care in Undergraduate Curriculum of Healthcare Professionals Qualification: A Systematic Scoping Review Protocol.

Clinical Practice Guidelines recommend interprofessional collaboration in palliative care. However, healthcare profession educators lack clear curricular guidance, particularly for undergraduate programs, to adequately train future professionals for effective participation in such teams. This systematic scoping review protocol aims to address this gap by: (i) mapping evidence on key characteristics of teaching palliative and end-of-life (EOL) care to undergraduate healthcare and social care students, and (ii) identifying the nature and effectiveness of educational interventions for improving palliative care education in the undergraduate curriculum. The protocol adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol Extension for Scoping Reviews (PRISMA-P-ScR) guidelines, while the proposed systematic scoping review study will be conducted based on methods and steps identified by Arksey and O'Malley and experts in the field. We will conduct systematic searches across five EBSCOhost databases using relevant search terms. Additionally, a limited grey literature search will be conducted on the first 100 results of Google Scholar and Open-Grey. The selection process will follow PRISMA-Extension for Scoping Reviews. Two independent reviewers will screen titles and abstracts for eligibility. Data extraction will be done on standardized forms in duplicate with cross-checking by a third reviewer. Braun and Clarke's thematic analysis approach, combining thematic and directed content analysis, will be employed for analysis. Intervention effectiveness will be narratively summarized based on the TIDieR checklist. Meta-analysis will be considered if applicable and data is homogeneous. Palliative care education (PCE) is a crucial element of undergraduate health professions education. This study's findings may aid educators in fostering optimal learning among healthcare students, who can then positively influence community health outcomes. The protocol was submitted for ethical clearance to the University of KwaZulu-Natal's Biomedical Research Ethics Committee and granted exemption from ethics review (00024289). We will disseminate findings through scientific journal publication and by sharing a summary with relevant institutions and attendees at health promotion and interprofessional education conferences.

Improving diagnostic of cervical dysplasia among postmenopausal women aged ≥50 years using local vaginal oestrogen treatment prior to colposcopy: study protocol for a multicentre randomised controlled trial (the IDEAL study)

IntroductionColposcopy is the most important diagnostic tool to detect cervical precancerous lesions and thereby prevention of cervical cancer. Due to age-dependent changes of the cervix, colposcopy is challenging in postmenopausal...

Zipime-Weka-Schista study protocol: a longitudinal cohort study and economic evaluation of an integrated home-based approach for genital multipathogen screening in women, including female genital schistosomiasis, human papillomavirus, Trichomonas and HIV in Zambia

IntroductionMultiplathogen home-based self-sampling offers an opportunity to increase access to screening and treatment in endemic settings with high coinfection prevalence of sexually transmitted (HIV, Trichomonas vaginalis (Tv), human papillomavirus (HPV))...

HIV-1 subtype-specific drug resistance on dolutegravir-based antiretroviral therapy: protocol for a multicentre longitudinal study (DTG RESIST).

HIV drug resistance poses a challenge to the United Nation's goal of ending the HIV/AIDS epidemic. The integrase strand transfer inhibitor (InSTI) dolutegravir, which has a higher resistance barrier, was endorsed by the World Health Organization in 2019 for first-, second-, and third-line antiretroviral therapy (ART). This multiplicity of roles of dolutegravir in ART may facilitate the emergence of dolutegravir resistance. DTG RESIST is a multicentre longitudinal study of adults and adolescents living with HIV in sub-Saharan Africa, Asia, and South and Central America who experienced virologic failure on dolutegravir-based ART. At the time of virologic failure whole blood will be collected and processed to prepare plasma or dried blood spots. Laboratories in Durban, Mexico City and Bangkok will perform genotyping. Analyses will focus on (i) individuals who experienced virologic failure on dolutegravir, and (ii) on those who started or switched to such a regimen and were at risk of virologic failure. For population (i), the outcome will be any InSTI drug resistance mutations, and for population (ii) virologic failure defined as a viral load >1000 copies/mL. Phenotypic testing will focus on non-B subtype viruses with major InSTI resistance mutations. Bayesian evolutionary models will explore and predict treatment failure genotypes. The study will have intermediate statistical power to detect differences in resistance mutation prevalence between major HIV-1 subtypes; ample power to identify risk factors for virologic failure and limited power for analysing factors associated with individual InSTI drug resistance mutations. The research protocol was approved by the Biomedical Research Ethics Committee at the University of KwaZulu-Natal, South Africa, and the Ethics Committee of the Canton of Bern, Switzerland. All sites participate in IeDEA and have obtained ethics approval from their local ethics committee to conduct the additional data collection. NCT06285110. - DTG RESIST is a large international study to prospectively examine emergent dolutegravir resistance in diverse settings characterised by different HIV-1 subtypes, provision of ART, and guidelines on resistance testing. - Embedded within the International epidemiology Databases to Evaluate AIDS (IeDEA), DTG RESIST will benefit from harmonized clinical data across participating sites and expertise in clinical, epidemiological, biological, and computational fields. - Procedures for sequencing and assembling genomes from different HIV-1 strains will be developed at the heart of the HIV epidemic, by the KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP), in Durban, South Africa. Phenotypic testing, Genome Wide Association Study (GWAS) methods and Bayesian evolutionary models will explore and predict treatment failure genotypes. - A significant limitation is the absence of genotypic resistance data from participants before they started dolutegravir treatment, as collecting and bio-banking pre-treatment samples was not feasible at most IeDEA sites. Consistent and harmonized data on adherence to treatment are also lacking. - The distribution of HIV-1 subtypes across different sites is uncertain, which may limit the statistical power of the study in analysing patterns and risk factors for dolutegravir resistance. The results from GWAS and Bayesian modelling analyses will be preliminary and hypothesis-generating.

Patients and Stakeholders' Perspectives Regarding the Privacy, Security, and Confidentiality of Data Collected via Mobile Health Apps in Saudi Arabia: Protocol for a Mixed Method Study.

There is data paucity regarding users' awareness of privacy concerns and the resulting impact on the acceptance of mobile health (mHealth) apps, especially in the Saudi context. Such information is pertinent in addressing users' needs in the Kingdom of Saudi Arabia (KSA). This article presents a study protocol for a mixed method study to assess the perspectives of patients and stakeholders regarding the privacy, security, and confidentiality of data collected via mHealth apps in the KSA and the factors affecting the adoption of mHealth apps. A mixed method study design will be used. In the quantitative phase, patients and end users of mHealth apps will be randomly recruited from various provinces in Saudi Arabia with a high population of mHealth users. The research instrument will be developed based on the emerging themes and findings from the interview conducted among stakeholders, app developers, health care professionals, and users of mHealth apps (n=25). The survey will focus on (1) how to improve patients' awareness of data security, privacy, and confidentiality; (2) feedback on the current mHealth apps in terms of data security, privacy, and confidentiality; and (3) the features that might improve data security, privacy, and confidentiality of mHealth apps. Meanwhile, specific sections of the questionnaire will focus on patients' awareness, privacy concerns, confidentiality concerns, security concerns, perceived usefulness, perceived ease of use, and behavioral intention. Qualitative data will be analyzed thematically using NVivo version 12. Descriptive statistics, regression analysis, and structural equation modeling will be performed using SPSS and partial least squares structural equation modeling. The ethical approval for this research has been obtained from the Biomedical and Scientific Research Ethics Committee, University of Warwick, and the Medical Research and Ethics Committee Ministry of Health in the KSA. The qualitative phase is ongoing and 15 participants have been interviewed. The interviews for the remaining 10 participants will be completed by November 25, 2023. Preliminary thematic analysis is still ongoing. Meanwhile, the quantitative phase will commence by December 10, 2023, with 150 participants providing signed and informed consent to participate in the study. The mixed methods study will elucidate the antecedents of patients' awareness and concerns regarding the privacy, security, and confidentiality of data collected via mHealth apps in the KSA. Furthermore, pertinent findings on the perspectives of stakeholders and health care professionals toward the aforementioned issues will be gleaned. The results will assist policy makers in developing strategies to improve Saudi users'/patients' adoption of mHealth apps and addressing the concerns raised to benefit significantly from these advanced health care modalities. DERR1-10.2196/54933.

Comparison of three diagnostic strategies for suspicion of pulmonary embolism: planar ventilation-perfusion scan (V/Q), CT pulmonary angiography (CTPA) and single photon emission CT ventilation-perfusion scan (SPECT V/Q): a protocol of a randomised controlled trial

IntroductionPulmonary embolism (PE) is a challenge to diagnose and when missed, exposes patients to potentially fatal recurrent events. Beyond CT pulmonary angiography (CTPA) and planar ventilation/perfusion (V/Q) scan, single photon...

Determination of factors influencing the retention in HIV care of adolescents during the Covid-19 pandemic in Lusaka Zambia

Background: Adolescents (ages 18-24) living with HIV are prone to disengagement from care, risking health deterioration and viral transmission. Identifying key barriers to adolescent retention is crucial for intervention development. This study aims to explore barriers and facilitators to adolescent HIV care retention. In Zambia, where 32% of 15–17-year-olds and 60% of 18–19-year-olds are sexually active, with low condom use rates, the risk of HIV and STIs is high. Despite Ministry of Health strategies, many HIV-positive adolescents in Zambia struggle with adherence. This study sought to investigate how various factors interact to influence HIV retention among adolescents in Lusaka, Zambia, employing an adapted Andersen framework. Its objectives include understanding factors impacting HIV retention, analysing predisposing factors, and examining health system influences on adolescent HIV care retention in Lusaka, Zambia. Methods: The study was conducted at University Teaching Hospital (UTH), Chilenje Hospital, and Chawama, Mtendere, and Kalingalinga) clinics in Lusaka, Zambia. Non-probability sampling, specifically purposive sampling, was employed. Semi-structured questionnaires were used for data collection and the quantitative data was analyzed using STATA 16.0. Findings will be disseminated through healthcare community, policy circles, among stakeholders and shared with UNZA's library. Ethical approval was obtained from The University of Zambia Biomedical Research Ethics Committee (UNZABREC) and permission from the Zambia National Health Research Authority (ZNHRA). Informed consent was obtained from participants, emphasizing voluntariness and the right to withdraw. Anonymity, confidentiality, and privacy was strictly upheld throughout the study. Results: The results highlight the nuanced nature of factors influencing adolescent retention in HIV care, emphasizing the importance of predictors such as education level, alcohol intake, belief in HIV cure through prayers, and perception of HIV as a significant life problem. The findings align with prior studies, warranting further exploration of support networks and experiences of non-engaged adolescents. Conclusion: In summary, this study makes a significant contribution to public health research by delving into the intricate factors impacting adolescent retention in HIV care in Lusaka, Zambia. The findings, aligned with research inquiries and existing literature, shed light on education, substance use, and psychosocial aspects. These insights lay the groundwork for tailored interventions, highlighting the significance of patient-centered strategies. Moreover, the study emphasizes the necessity for continued exploration of support networks, disclosure challenges, and broader societal dynamics affecting healthcare engagement. This insight informs future research endeavors aimed at enhancing the well-being of adolescents living with HIV. Recommendations include improve medication access through mobile services, provide financial aid integrated with counseling, personalize adherence plans, involve social networks, respect religious beliefs, address geographic disparities, monitor long-term health, and pilot targeted interventions. Policies should establish guidelines for medication access and financial assistance.

Postgraduate Master of Medicine student perspectives on data access and record-keeping for research

Background. Registrars in specialisation training programmes encounter numerous difficulties in completing the research component of the Master of Medicine degree. Poor patient record-keeping hinders the research process. Objectives. To investigate current types of medical patient record-keeping systems (electronic v. paper) in training health facilities, and the effect data accessibility has on specialist training and research. Methods. This was a mixed-methods study that included both descriptive and analytical components. Of 610 postgraduate students enrolled in the University of KwaZulu-Natal College of Health Sciences Master of Medicine programme, 168 completed a cross-sectional survey to collect data and 11 did follow-up interviews. The survey and interviews explored issues related to medical record-keeping in the participants’ department or hospital, emphasising their experiences with data access while conducting research. The quantitative data were analysed using descriptive statistics, and the qualitative data were analysed thematically. Ethical approval was obtained from the institution’s Biomedical Research Ethics Committee. Results. Of the 168 participants, 94 (56%) reported that problems with data access hindered their research, while 56 (33%) indicated that data access did not affect their research. Only 30 participants (18%) had no difficulty in obtaining data for their research, while the rest (n=138; 82%) experienced varying degrees of difficulty. A total of 110 participants (65%) indicated that paper-based record-keeping was mainly being used in their department or hospital, while electronic record-keeping was reported by the rest (n=58; 35%). Many (n=125; 74%) expressed the need to improve hospital data management practices, and 39 (23%) reported that plans were being implemented to improve these practices. Participants expressed frustration with regard to accessing data even in departments that used electronic systems, and they raised concerns regarding data security. Conclusion. The migration to electronic patient record-keeping has not yet been implemented in many hospitals, with poor patient record-keeping affecting training and research.

The Puzzles in Research-Ethics Review

There are puzzles in research-ethics review that confound researchers in the social sciences. First, how did the biomedical research ethics process capture the research-ethics perspectives in the social sciences? Second, why has it proved impossible to recognize the relevance of stepping outside the biomedical paradigm? Third, what institutional agencies have not permitted researchers in the social sciences to abandon the biomedical paradigm and adopt one that is relevant for social scientists? There are particular elements that characterize the ethics-review process. Some phrases as ‘rigor’ dissuade inductive researchers, the power of hierarchical nature of research-ethics committees inevitably impose the biomedical stance in research, the colonizing nature of research-ethics betrays its American bias, and the insistence that all researchers implement a data-management plan is not relevant to the social sciences. Some of the more common suggestions to improve the situation are unworkable.

Liver fat as a dietary target by Chinese Medical Nutrition Therapy (CMNT) diet for treating type 2 diabetes with non-alcoholic fatty liver disease: study protocol for a randomised controlled trial

IntroductionType 2 diabetes and non-alcoholic fatty liver disease (NAFLD) often coexist and increase risk for developing liver fibrosis and diabetes complications if no effective measures are taken. Dietary intervention is...

Assessment of the correlation between supracrestal gingival tissue dimensions and other periodontal phenotypes components via the digital registration method: a cross‑sectional study in a Chinese population

BackgroundSupracrestal gingival tissue dimensions (SGTDs) has been considered to be an essential element of periodontal phenotype (PP) components. This study aimed to explore the relationship between SGTDs and other PP components by digital superposition method that integrated cone beam computed tomography (CBCT) with intraoral scanning.MethodsThis cross-sectional study was conducted at the Stomatology Hospital of Fujian Medical University. Participants were recruited based on the inclusion and exclusion criteria. The data obtained from the digital scanner (TRIOS 3, 3Shape, Denmark) and CBCT images were imported into the TRIOS software (Implant Studio, 3Shape, Denmark) for computing relevant parameters. The significant level was set at 0.05.ResultsA total of 83 participants with 498 maxillary anterior teeth were finally included. The mean values of supracrestal gingival height (SGH) and the distance from the cementoenamel junction (CEJ) to the crest of the alveolar ridge (CEJ-ABC) on the buccal site were significantly higher than palatal SGH (SGH-p) and palatal CEJ-ABC (CEJ-ABC-p). Men exhibited taller CEJ-ABC and SGH-p than women. Additionally, tooth type was significantly associated with the SGH, SGH-p and CEJ-ABC-p. Taller SGH was associated with wider crown, smaller papilla height (PH), flatter gingival margin, thicker bone thickness (BT) and gingival thickness (GT) at CEJ, the alveolar bone crest (ABC), and 2 mm apical to the ABC. Smaller SGH-p displayed thicker BT and GT at CEJ, the ABC, and 2 and 4 mm apical to the ABC. Higher CEJ-ABC showed lower interproximal bone height, smaller PH, flatter gingival margin, thinner GT and BT at CEJ, and 2 mm apical to the ABC. Smaller CEJ-ABC-p displayed thicker BT at CEJ and 2 and 4 mm apical to the ABC. On the buccal, thicker GT was correlated with thicker BT at 2 and 4 mm below the ABC.ConclusionSGTDs exhibited a correlation with other PP components, especially crown shape, gingival margin and interdental PH. The relationship between SGTDs and gingival and bone phenotypes depended on the apico-coronal level evaluated.Trial registrationThis study was approved by the Biomedical Research Ethics Committee of Stomatology Hospital of Fujian Medical University (approval no. 2023-24).

The Culture of Research: A Systematic Scoping Review

Introduction: Research culture is the core of many processes in science. It is a broad concept presumably entailing practices, traditions, norms, etc. that prevail among researchers and other stakeholders in the field. Its definition, architecture, and taxonomy are essential in generating and pursuing scientific policies at universities and countries. As there is a lack of comprehensive reviews on research culture, the present publication aspires to fill the existing gap in the knowledge. This review aims to define research culture and build an architecture of research culture based on the relevant literature indexed in the Scopus database. Method: The problem, concept, and context (PCC) framework was applied to establish an effective search strategy and word the research questions corresponding to the aim. Based on Arksey and O'Malley's methodology (2005) and PRISMA checklist (2020) for systematic reviews, the authors sorted out 56 relevant publications for systematic scoping review. In addition, a bibliometric analysis was applied to examine the field. Results: Using a bibliometric analysis, the 56 publications were distributed by year, country, most prolific authors, sources, research fields, affiliation, and type of publication. With the help of VOSviewer, the authors singled out four thematic clusters (research culture; medical and biomedical research, methodology and research ethics, and clinical studies and human experiments). After synthesizing the data extracted from the documents under review, research culture was defined; components of research culture were singled out and summed up; and a framework of research culture was made up. The authors analysed the review findings in contrast with other research, offering their own comprehensive definition of research culture, its taxonomy, and an architecture of research culture. Conclusion: The current review adds to the understanding of research culture, its gist, component classification. The limitation related to the period of review (2019-2024) may be overcome by further reviews of relevant publications from a historic perspective that would broaden perceptions of the origin of modern research culture and its negative aspects.