Ethical Checklists for Clinical Research Projects and laboratory medicine: two tools to evaluate compliance with bioethical principles in different settings.

OBJECTIVES: To develop two ethical checklists to evaluate (i) management of ethical concerns in research projects and (ii) awareness of ethical conduct of healthcare laboratory professionals. METHODS: Comprehensive discussion among the members of IFCC Task Force on Ethics based on pertinent literature. RESULTS: This Checklist for Clinical Research Projects should be useful to evaluate research proposals from an ethical perspective before submitting it to an IRB or its equivalent, thereby diminishing rejection rates and resulting in more time-effective projects. The checklist designed to evaluate the ethical conduct in laboratory medicine could be useful for self evaluation (internal audits) and for certification/accreditation processes performed by third parties. CONCLUSIONS: These checklists are simple but powerful tools useful to guide professionals to adhere to ethical principles in their practice, especially in developing countries where accredited ethics committees may be difficult to find.

The ESCMID Study Group for Clostridioides difficile: History, Role, and Perspectives.

Clostridioides difficile (C. difficile) is a major nosocomial pathogen but is also increasingly recognised as an important diarrhoeal pathogen in the community, not always associated with antibiotics. The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for C. difficile (ESGCD) is a group of clinicians, scientists, and others from many European countries and further afield, who share a common interest in C. difficile. The aims of the Study Group are centred around raising the profile of  C. difficile infection (CDI) in humans and animals, fostering collaboration amongst centres in different European countries and providing a forum for discussing and disseminating information. One of the principal aims of the Study Group is to raise awareness of C. difficile infections in Europe. ESGCD has a particular interest in the development and dissemination of European guidance on prevention, diagnosis, and treatment of CDI. This chapter will discuss the organisation of ESGCD within the ESCMID Study Group structure, the origins of the Study Group, the aims, and objectives of the group, and will highlight some of the past and present activities of ESGCD in relation to these.

Students' perceived research skills development and satisfaction after completion of a mandatory research project: results from five cohorts of the Sydney medical program.

BACKGROUND: Research activities undertaken during University studies contribute to preparation of medical students for practice of evidence-based medicine. This study aimed to understand medical students' experiences, perceived research skills development and satisfaction associated with completion of mandatory research projects. METHODS: An online survey was sent to five cohorts of students (n = 1375) from years 2017-2021 at the completion of their research projects. Univariate analysis was conducted to understand students' perception of research skills development, followed by linear regression modeling to explore factors influencing satisfaction with their research project. Manifest content analysis employing a framework approach was used to analyse qualitative data from responses to open ended questions. RESULTS: Response rate was 42%, with 513 (89%) returned surveys being complete and included in analysis. Whilst 37% of students felt they had requisite research skills before undertaking the research project, 84% reported they had these skills after completing the project (χ2 = 8.99, P = 0.02). Mean satisfaction score of the students was 5.0/10 (+/- 2.5, median = 6 (IQR = 3.0-7.0) with 59% of students reporting satisfaction scores higher than the average. Higher satisfaction scores were reported by those who perceived that: research methods and teaching was useful in preparing them for conducting research; the research project helped them acquire new skills; the project resulted in peer-reviewed publication; and, who felt supported by their supervisors. Responses to open ended questions offered important insights into student experience and emphasised the importance of supportive supervisors and the need for a dedicated research block in the busy medical program. CONCLUSIONS: The majority of students reported positive outcomes from the mandatory research project. Student satisfaction can be improved by ensuring supportive research environments and high-quality supervision, and inclusion of dedicated research time in the medical curriculum.

Research supervisors' views of barriers and enablers for research projects undertaken by medical students; a mixed methods evaluation of a post-graduate medical degree research project program.

BACKGROUND: Medical degree programs use scholarly activities to support development of basic research skills, critical evaluation of medical information and promotion of medical research. The University of Sydney Doctor of Medicine Program includes a compulsory research project. Medical student projects are supervised by academic staff and affiliates, including biomedical science researchers and clinician-academics. This study investigated research supervisors' observations of the barriers to and enablers of successful medical student research projects. METHODS: Research supervisors (n = 130) completed an anonymous, online survey after the completion of the research project. Survey questions targeted the research supervisors' perceptions of barriers to successful completion of projects and sources of support for their supervision of the student project. Data were analysed by descriptive statistics and using manifest content analysis. Further quantitative investigation was made by cross-tabulation according to prior research supervision experience. RESULTS: Research supervisors reported that students needed both generic skills (75%) and research-based skills (71%) to successfully complete the project. The major barrier to successful research projects was the lack of protected time for research activities (61%). The assessment schedule with compulsory progress milestones enabled project completion (75%), and improved scientific presentation (90%) and writing (93%) skills. Supervisors requested further support for their students for statistics (75%), scientific writing (51%), and funding for projects (52%). Prior research supervision experience influenced the responses. Compared to novice supervisors, highly experienced supervisors were significantly more likely to want students to be allocated dedicated time for the project (P < 0.01) and reported higher rates of access to expert assistance in scientific writing, preparing ethics applications and research methodology. Novice supervisors reported higher rates of unexpected project delays and data acquisition problems (P < 0.05). Co-supervision was favoured by experienced supervisors but rejected by novice supervisors. CONCLUSIONS: Both generic and research-related skills were important for medical student research project success. Overall, protected research time, financial and other academic support were identified as factors that would improve the research project program. Prior research supervision experience influences perceptions of program barriers and enablers. These findings will inform future support needs for projects and research supervisor training for the research supervision role.

Cooking a Research Project: New Trends in the Kitchen and in Scientific Policies.

The culture of chefs from the world's best restaurants is substituted by new trends paradigmatically epitomized by the TV program Masterchef. The authors feel that a similar transformation affects modern research. Recent scientific policies constrict the design of research grants with the aim of short-term maximization of the monetary value generated by the researcher.

Short-term research projects in cognitive neuroscience for undergraduate students: a contingency plan to maintain quality teaching during COVID-19 pandemic.

The Corona Virus Disease 19 (COVID-19) pandemic has imposed serious restrictions for academic institutions to maintain their research and teaching practical subjects. Universities have implemented adaptive measures to maintain educational activities and achieve the learning objectives for undergraduate and postgraduate students by shifting to online teaching and learning. Although such approaches have enabled delivering the theoretical content of courses during the pandemic, universities have faced serious difficulties in running practicals with actual research experiments and teaching hand-on skills because such activities potentially override the required safety guidelines. Here, we report an adaptive measure, implemented at Monash University, to run home-based studies in cognitive neuroscience and achieve learning objectives, which are normally delivered in face-to-face practicals. We introduce two specifically designed short-term research projects and describe how different aspects of these projects, such as tutorials, experiments, and assessments, were modified to meet the required social distancing. The results of cognitive tests were closely comparable between the laboratory-based and home-based experiments indicating that students followed the guidelines and the required procedures for a reliable data collection. Our assessments of students' performance and feedback indicate that the majority of our educational goals were achieved, while all safety guidelines and distancing requirements were also met.

[Categorizing methods used in participatory research]. / Systematisierung von Methoden partizipativer Forschung.

BACKGROUND: Participatory research methods are gaining interest. In applying these methods, there is often a lack of consideration for methodological issues. Furthermore, a unifying system for categorizing the various approaches does not exist. OBJECTIVES: Based on a scoping review, a categorization of participatory research methods to promote health equity was undertaken. MATERIAL AND METHODS: Included in the review are 44 publications in German and English retrieved from various databases (PubMed, PsycInfo, SocIndex, Livivo, Cochrane, Fachportal Pädagogik). Additional publications were identified by hand searching and using the snowball method. RESULTS: The methods are categorized by research phase and type of format used. The principles of multidimensionality and phase integration are central to the proposed system of categorization, resulting in a primary distinction between the methods used to facilitate the participatory research process versus methods used for participatory data collection and analysis. The majority of methods identified are used for data collection or reflexive processes. There are gaps in the German literature regarding methods for cooperative decision making, participatory data analysis, and the application of research results. CONCLUSION: The classification system provides an overview of available methods and the degree of participation they promote. The system draws attention to the spectrum of methods available, being useful for both teaching and research purposes.

A 5-year retrospective evaluation of undergraduate dental research projects in a Nigerian University: Graduates' perceptions of their learning experiences.

INTRODUCTION: Undergraduate research projects have never been evaluated despite six decades of dental training in Nigeria. This study evaluated dental graduates' perceptions of the research project from 2013 to 2017. METHODS: A cohort of 93 graduates from a Nigerian University was investigated through the use of self-administered questionnaires on a Google form platform. Analysis was done using descriptive and analytical statistics on SPSS version 16. Statistical significant level was set at P < .05. RESULTS: The cohort showed a very good understanding of research project objectives during their undergraduate training with more male and older students independently choosing their research topics (P > .05). Students' research topics were changed by supervisors in about one-quarter and one-tenth of the male and female students, respectively. About one-third of the students met set deadlines with no significant differences amongst gender and age groups (P > .05). However, only two-thirds of the students submitted their projects before the deadline due to other contending academic works. More males and older age group sought assistance from other academic staff for information on their projects. About one-half of the students reportedly acquired additional knowledge as a direct benefit from the project. Of all the variables associated with the research project, only the level of preparedness to undertake the project was highly statistically significant (P < .05) and this varied significantly amongst gender and age group (P < .05). CONCLUSION: The students demonstrated a good understanding of research project. The perceived level of preparedness to undertake the project was low but significantly higher in male and older age groups.

Creating the Next Generation of Evidence-Based Veterinary Practitioners and Researchers: What are the Options for Globally Diverse Veterinary Curricula?

Veterinary educators strive to prepare graduates for a variety of career options with the skills and knowledge to use and contribute to research as part of their lifelong practice of evidence-based veterinary medicine (EBVM). In the veterinary curriculum, students should receive a grounding in research and EBVM, as well as have the opportunity to consider research as a career. Seeing a lack of a cohesive body of information that identified the options and the challenges inherent to embedding such training in veterinary curricula, an international group was formed with the goal of synthesizing evidence to help curriculum designers, course leaders, and teachers implement educational approaches that will inspire future researchers and produce evidence-based practitioners. This article presents a literature review of the rationale, issues, and options for research and EBVM in veterinary curricula. Additionally, semi-structured interviews were conducted with 11 key stakeholders across the eight Council for International Veterinary Medical Education (CIVME) regions. Emergent themes from the literature and interviews for including research and EBVM skills into the curriculum included societal need, career development, and skills important to clinical professional life. Approaches included compulsory as well as optional learning opportunities. Barriers to incorporating these skills into the curriculum were grouped into student and faculty-/staff-related issues, time constraints in the curriculum, and financial barriers. Having motivated faculty and contextualizing the teaching were considered important to engage students. The information has been summarized in an online "toolbox" that is freely available for educators to inform curriculum development.

[The Leon Fredericq Foundation against COVID-19 in Liege]. / La Fondation Léon Fredericq contre la COVID-19 à Liège.

The Leon Fredericq Foundation gives support to the clinicians and the scientists of the Uliege and of the CHU of Liege in order to push back the frontiers of biomedical science and to contribute to improve the care and cure of patients. Since the outbreak due to COVID-19, the Foundation has given out a call for donations in order to support urgent procedures for taking care of COVID-19 suffering patients. Furthermore, by raising important financial means, the Foundation has selected thirteen research projects aiming at a better understanding of the SARS-CoV-2-induced disease.

La Fondation Léon Fredericq soutient les médecins et les chercheurs de l'ULiège et du CHU de Liège pour faire reculer les frontières de la connaissance et contribuer à améliorer les soins aux patients. Dès le début de la crise due à la COVID-19, elle a lancé un appel aux dons visant à permettre au CHU de prendre des mesures d'urgence pour la prise en charge des patients atteints de cette maladie. En outre, en mobilisant des moyens financiers importants, elle a sélectionné treize projets de recherche visant à mieux comprendre les conséquences d'une infection par le SARS-CoV-2.

The ESCMID Study Group for Clostridium difficile: History, Role and Perspectives.

C. difficile is a major nosocomial pathogen, but is also increasingly recognised as an important diarrhoeal pathogen in the community, not always associated with antibiotics. The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Clostridium difficile (ESGCD) is a group of clinicians and scientists from many European countries and further afield, who share a common interest in C. difficile. The aims of the Study Group are centred around raising the profile of CDI in humans and animals, fostering collaboration amongst centres in different European countries and providing a forum for discussing and disseminating information. One of the principal aims of the Study Group is to raise awareness of C. difficile infections in European hospitals. ESGCD has a particular interest in the development and dissemination of European guidance on prevention, diagnosis and treatment of CDI. This chapter will discuss the organisation of ESGCD within the ESCMID Study Group structure, the origins of the Study Group, the aims and objectives of the group, and will highlight some of the past and present activities of ESGCD in relation to these.

An analysis of the NIH-supported sickle cell disease research portfolio.

Sickle cell disease (SCD), an inherited blood disorder is due to a single amino acid substitution on the beta chain of hemoglobin, and is characterized by anemia, severe infections, acute and chronic pain, and multi-organ damage. The National Institutes of Health (NIH) is dedicated to support basic, translational and clinical science research to improve care and ultimately, to find a cure for SCD that causes such suffering. This report provides a detailed analysis of grants funded by the NIH for SCD research in Fiscal Years 2007 through 2013. During this period, the NIH supported 247 de novo grants totaling $272,210,367 that address various aspects of SCD. 83% of these funds supported research project grants investigating the following 5 scientific themes: Pathology of Sickle Red Blood Cells; Globin Gene Expression; Adhesion and Vascular Dysfunction; Neurological Complications and Organ-specific Dysfunction; and Pain Management and Intervention. The remaining 17% of total funds supported career development and training grants; Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants; large Center grants; and Conference grants. Further analysis showed that the National Heart, Lung, and Blood Institute (NHLBI) is the largest funder of SCD research within NIH with 67% of total grants, contributing 77% of total funds; followed by the National Institute for Digestive Diseases and Kidney (NIDDK) that is funding 19% of grants, contributing 13% of total funds. The remaining 14% of grants totaling 10% of the funds were supported by all other NIH Institutes/Centers (ICs) combined. In summary, the NIH is using multiple funding mechanisms to support a sickle cell disease research agenda that is intended to advance the detection, treatment, and cure of this debilitating genetic disease.

ResearchConnect.info: An Interactive Web-Based Platform for Building Academic Collaborations.

RATIONALE AND OBJECTIVES: Radiology is a rapidly evolving field that benefits from continuous innovation and research participation among trainees. Traditional methods for involving residents in research are often inefficient and limited, usually due to the absence of a standardized approach to identifying available research projects. A centralized online platform can enhance networking and offer equal opportunities for all residents. MATERIALS AND METHODS: Research Connect is an online platform built with PHP, SQL, and JavaScript. Features include project and collaboration listing as well as advertisement of project openings to medical/undergraduate students, residents, and fellows. The automated system maintains project data and sends notifications for new research opportunities when they meet user preference criteria. Both pre- and post-launch surveys were used to assess the platform's efficacy. RESULTS: Before the introduction of Research Connect, 69% of respondents used informal conversations as their primary method of discovering research opportunities. One year after its launch, Research Connect had 141 active users, comprising 63 residents and 41 faculty members, along with 85 projects encompassing various radiology subspecialties. The platform received a median satisfaction rating of 4 on a 1-5 scale, with 54% of users successfully locating projects of interest through the platform. CONCLUSION: Research Connect addresses the need for a standardized method and centralized platform with active research projects and is designed for scalability. Feedback suggests it has increased the visibility and accessibility of radiology research, promoting greater trainee involvement and academic collaboration.

Exploring research and education opportunities in digital health for pharmacy, medicine and other health disciplines: Insights from a multinational workshop.

Digital healthcare has rapidly evolved during and in the post-COVID pandemic era, expanding the roles and responsibilities of community pharmacists. Services like telepharmacy, e-prescriptions, remote medication therapy management, and digital monitoring of chronic conditions, have evolved into everyday routine pharmacy practices. Pharmacists are at the forefront and the most accessible healthcare professionals for patients and are increasingly pivotal in providing comprehensive patient care, including digital patient care services. To ensure that future generations of pharmacists are digitally competent, it is crucial that digital health education is provided to pharmacy students. Furthermore, fostering high-quality multidisciplinary research, particularly in collaboration with medicine and other health disciplines, is essential for advancing the digital health skills of the future pharmacy workforce. Despite the growing use of digital health technologies, there are significant between-country differences in digital health education, the clinical settings in which digital health technologies are used, and their implementation in day-to-day practice. This commentary summarizes key insights from the International Digital Health Workshop held at the University of Sydney in November 2023. To help ensure pharmacists are included as participants in future digital health research, recent advances in digital health education and interprofessional research projects across three universities from far-off world regions were presented. Participants discussed a possible collaborative, interprofessional, and international research project on chronic disease prevention using digital health technologies. The need for interdisciplinary digital health curricula was highlighted in the workshop discussions, specifically tailored to address the knowledge requirements of pharmacists and other healthcare professionals.

A case study on the relationship between risk assessment of scientific research projects and related factors under the Naive Bayesian algorithm.

This paper delves into the nuanced dynamics influencing the outcomes of risk assessment (RA) in scientific research projects (SRPs), employing the Naive Bayes algorithm. The methodology involves the selection of diverse SRPs cases, gathering data encompassing project scale, budget investment, team experience, and other pertinent factors. The paper advances the application of the Naive Bayes algorithm by introducing enhancements, specifically integrating the Tree-augmented Naive Bayes (TANB) model. This augmentation serves to estimate risk probabilities for different research projects, shedding light on the intricate interplay and contributions of various factors to the RA process. The findings underscore the efficacy of the TANB algorithm, demonstrating commendable accuracy (average accuracy 89.2%) in RA for SRPs. Notably, budget investment (regression coefficient: 0.68, P < 0.05) and team experience (regression coefficient: 0.51, P < 0.05) emerge as significant determinants obviously influencing RA outcomes. Conversely, the impact of project size (regression coefficient: 0.31, P < 0.05) is relatively modest. This paper furnishes a concrete reference framework for project managers, facilitating informed decision-making in SRPs. By comprehensively analyzing the influence of various factors on RA, the paper not only contributes empirical insights to project decision-making but also elucidates the intricate relationships between different factors. The research advocates for heightened attention to budget investment and team experience when formulating risk management strategies. This strategic focus is posited to enhance the precision of RAs and the scientific foundation of decision-making processes.

The impact of funding disruptions on large-scale teen pregnancy prevention research projects.

To advance the field of teen pregnancy prevention, new interventions must be developed and tested. The federal Teen Pregnancy Prevention program (TPP) funds the evaluation of promising interventions. We report on a funding disruption to 21 TPP Tier 2B research grantees across the US that was unusual for its ideological causation, sudden timing, severity, and ultimately court decisions compelling the agency to reverse the decision. We address the following question: How did challenges presented by the attempted funding termination impact grantees' ability to continue with their intended research? Results from grantee surveys in 2019 demonstrate the funding disruption negatively impacted participant recruitment, organizational collaboration, program delivery, research rigor, and compromised grantees' ability to complete high-quality evaluations. Results also show most projects could continue, with modified research goals, when funding was reinstated. We conclude administrations should avoid arbitrarily and prematurely terminating research projects. However, there is merit in reinstating funds to projects should a disruption occur. Results from this work are particularly relevant as we anticipate how health research projects may manage other disruptions to funding or timetables, such as those caused by COVID-19. Results are relevant to policy makers, researchers, government and private funders, grantees, and technical assistance teams.

Rapid Rescoping and Adaptation: An Evaluation of the Impact of COVID-19 on Postgraduate Medical Student Research Projects.

The COVID-19 pandemic has adversely affected tertiary science and medical education, with significant impact on research-related activities. Research projects are a mandatory requirement of the Doctor of Medicine (MD) Program at the University of Sydney, and medical student projects are delivered across multiple sites in metropolitan and rural New South Wales, Australia. Several cohorts of medical students had projects that were affected by COVID-19. The aims of this study were to determine the impact of COVID-19 on medical student research projects and describe the measures taken to rescope projects, to support students in meeting the learning objectives of the program. Mandatory submission statements for all medical student research project scientific reports for 2020-2022 were examined for reports of the effect of COVID-19 on the project, including COVID-19 related delays, downsizing and the need to change research project types. During the study period, a total of 760 student reports were submitted, of which 217 (28.7%) were affected by COVID-19. About 50% were significantly delayed, 30% were downsized, and 6% required completely new projects. Rescoping arrangements implemented facilitated the successful completion of projects. Overall, the final student grades for the research projects were unaffected by COVID-19 or the related project rescoping. Whilst significantly impacted by COVID-19, medical student research projects were completed with provision of appropriate rescoping plans and academic support. Ensuring projects have a documented contingency plan secured projects as the pandemic progressed and will be a useful safeguard for all future project delivery.

Clustering networked funded European research activities through rank-size laws.

This paper treats a well-established public evaluation problem, which is the analysis of the funded research projects. We specifically deal with the collection of the research actions funded by the European Union over the 7th Framework Programme for Research and Technological Development and Horizon 2020. The reference period is 2007-2020. The study is developed through three methodological steps. First, we consider the networked scientific institutions by stating a link between two organizations when they are partners in the same funded project. In doing so, we build yearly complex networks. We compute four nodal centrality measures with relevant, informative content for each of them. Second, we implement a rank-size procedure on each network and each centrality measure by testing four meaningful classes of parametric curves to fit the ranked data. At the end of such a step, we derive the best fit curve and the calibrated parameters. Third, we perform a clustering procedure based on the best-fit curves of the ranked data for identifying regularities and deviations among years of research and scientific institutions. The joint employment of the three methodological approaches allows a clear view of the research activity in Europe in recent years.

Can Antibiotic Stewardship Be Achieved by Utilizing the Stewardship Through Educating Patients (S.T.E.P.) Process?

BACKGROUND: Despite research and efforts to mitigate bacterial resistance, antibiotic overprescribing continues to occur, often due to real or perceived expectations of patients.  Objective: The purpose of this study was to determine: (1) if there's an association between the provider's patient education efforts and the patient's satisfaction, and (2) the research participant's subsequent behavior concerning antibiotic prescriptions, by utilizing the Stewardship Through Educating Patients (S.T.E.P.) process for positive prescriptive change. The S.T.E.P. program features straightforward, simple education via face-to-face counseling at patient encounters, along with presenting applicable printed educational pamphlets from the Centers for Disease Control and Prevention (CDC). These two interventions were utilized in this study with research participants from the healthcare provider, with education focused on appropriate antibiotic use in the treatment of adults diagnosed with common illnesses such as an upper respiratory infection (the common cold), acute sinusitis, and acute bronchitis, which oftentimes are viral in origin. METHOD: This Quality Improvement (QI) interventional study utilized the researcher's direct face-to-face patient education and CDC printed materials as a measure of antibiotic prescribing as a primary outcome, with patient satisfaction as a secondary outcome via convenience sampling of 40 hospital employees who utilized a free hospital-based employee healthcare clinic. RESULTS: Patient-teaching by this study's researcher, along with supplemental printed patient education material from the CDC that were given to research participants during an initial medical encounter, were effective interventions used in reducing antibiotic prescribing, as evidenced by a positive patient satisfaction in 95% of research participants. CONCLUSIONS: Antibiotic use in the treatment of adults diagnosed with common illnesses such as an upper respiratory infection (the common cold), acute sinusitis, and acute bronchitis, may be safely reduced by using a combination of patient-education and clinician intervention.

Building Connections to Biology and Community through Service-Learning and Research Experiences.

Service-learning and undergraduate research experiences are high-impact practices that have become more common in the sciences, but the benefits of short-term experiences have not been thoroughly investigated. The purpose of this study was to compare within-semester gains for students in a short-term service-learning (SL) or short-term research project (RP) in terms of students' (i) motivation to learn biology, (ii) scientific literacy, (iii) perception of the relevance of biology to their lives, and (iv) learning gains associated with course learning outcomes. The impacts of brief service-learning and research project experiences were compared using direct and indirect assessments, including qualitative coding of open-ended response questions and quantitative analysis of exams and Likert-type items. We found few differences between students in the two projects regarding their changes in motivation (both slightly negative), scientific literacy (both gains), and their ability to connect biology to their lives (both gains). Emergent themes revealed that both projects influenced students' plans for future research and service-learning. Both projects helped students build relationships; however, RP students built relationships with classmates, while SL students built relationships with community members. The positive experiences highlight the need for engaging science students through service-learning in addition to research.