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This article details a 'puzzling' teaching and learning method to engage undergraduate nursing (BSN) and exercise sciences (BSES) students in physiology or medicine Nobel Prize-winning discoveries, while reviewing course material through the "Puzzling Physiology and Nobel Laureates" (PPNL) game. The qualitative evaluations of 117 undergraduate BSN and BSES students revealed that 95% and 96%, respectively, agreed the game provided an opportunity to utilize critical thinking and problem-solving skillsets. Moreover, 96% of the 117 anonymous student respondents voted on increasing the number of PPNL game sessions per semester, and 94% agreeing the gamified learning strategy should be offered in subsequent classes as well. Interestingly, nearly 90% agreed that the learning experience was 'fun', and that it increased awareness of physiology and/or medicine discoveries. The style of the "Puzzling Physiology and Nobel Laureates" game lends to its reproducibility in a wide array of physiology courses for both majors and nonmajors.

Lexical bundles (LBs) are frequent groups of words that appear repeatedly in different academic texts. A plethora of research has explored their distribution and usage in general, particularly in academic texts. However, to our knowledge, the extent of research investigating LBs in the discussion sections of Medical Research Articles (MRAs) is scant. The present study examined the diversity and density of four-word LBs in the discussions of 1400 MRAs. Four-word bundles totaling 413, including general and subject-bound LBs, were extracted using the freeware "concordance software program" AntConc and categorized based on their syntactic structures and discourse functions. The findings revealed that discussions structurally rely heavily on phrasal LBs (i.e., prepositional phrases and noun phrases) in general and subject-bound LBs compared to clausal bundles, which include VP-based and Clause-based LBs. Regarding functional categories, the general referential bundles with their subcategories were found to have the most considerable proportion in the medical RA genre. Given the importance of LBs in disciplinary writing and academic discourse, the findings could be instrumental in crafting suitable pedagogical materials and activities on general and subject-specific LBs for academic writing in English for Medical Purposes.

This paper describes a scoping review of China's academic resource databases, relevant official websites, news reports and public accounts spanning a period from the end of 2019 to the end of 2022, to investigate the challenges in scientific integrity and ethical soundness of research conducted during and immediately after the COVID-19 pandemic in China. By conducting the scoping review with keywords related to the research questions in Chinese, relevant data were extracted and classified into four categories: challenges in research, challenges in ethics review, challenges in publishing academic work, and research ethics guidelines during and after the pandemic. The paper points out that problematic studies and findings increased with the escalation in medical research projects during the pandemic in China. The situation faced by researchers was more difficult than before the pandemic. The mode of informed consent, and ethics review and oversight systems also underwent changes. In addition, Traditional Chinese Medicine as an alternative medical treatment for COVID-19, attracted attention from the research community and became a topic of discussion. We conclude that the various challenges and concerns identified indicate a need for a proper and timely response system be formulated in preparation for possible future occurrences of new pandemics or other critical situations.

This article describes our efforts to screen and enrol clinical trial participants conscientiously in the COVID-19 pandemic setting. We present the standard screening and enrolment process prior to, and our process of adapting to, the pandemic. Our goal was to develop a way to screen and enrol people for clinical trials that was both equitable and effective. In addition, we outline the steps our research department took to ensure that ethical, clinical and logistical factors were considered when matching a patient to a clinical trial.

During the COVID-19 pandemic, the race to find an effective vaccine or treatment saw an 'extraordinary number' of clinical trials being conducted. While there were some key success stories, not all trials produced results that informed patient care. There was a significant amount of waste in clinical research during the pandemic which is said to have hampered an evidence-based response. Conducting trials which could have been predicted to fail to answer the research question (e.g. because they are not large enough to provide a definitive result) is not only a waste of resources but also a breach of research participants' trust and a violation of research ethics. The issues seen in COVID-19 clinical trials are symptomatic of a wider trial design crisis where many trials do not provide informative results. This paper examines the roles of key stakeholders in delivering ethical and informative trials and whether guidance published by 'The Good Clinical Trials Collaborative' could be used to align key stakeholder groups and enable a joined-up approach to improve clinical trial design.

Global health emergencies often lead to a proliferation of health-related research and resultant data, which is shared across borders to help control the outbreak of disease and support decision-making regarding public health interventions. However, efforts to share data can be hindered by diverse international ethical and legal frameworks. The frameworks aim to govern coordinated processing, sharing and transfer of health data across borders thus placing burdens on researchers who are willing or obligated to share data. In this paper, we investigate ethical values and legal principles that can be applied to ensure a more streamlined approach in the governance of cross-border health data sharing during global health emergencies. A scoping review approach was used to better understand emerging evidence about issues related to the ethical and legal governance of cross-border health data sharing. We first highlight the challenges of sharing health data across borders. We then discuss how the challenges might be overcome through the application of ethical values and legal principles that have been identified in literature. This is followed by a proposal for possible ways of streamlining the governance of health data sharing from ethical and legal perspectives in a bid to better prepare for future global health emergencies and promote the responsible sharing of health data.

The COVID-19 pandemic and subsequent policies (e.g., social distancing, travel restrictions) challenged both organizers for and attendees of programs typically held in person. Many scientific training programs quickly adapted to virtual formats by incorporating digital assets developed for virtual learning and remote social engagement. At the outset, the value of continuing digital elements with future in-person events was unclear. To examine how virtual resources supported heterogeneous professional training programs, we reviewed survey data for a 14-year-old training program for scientific professionals titled "Isotope Tracers in Metabolic Research: Principles and Practice of Kinetic Analysis." We found a positive relationship between survey satisfaction and the postpandemic in-person program that included digital assets held in 2022 compared to prepandemic in-person programs. To better understand the postpandemic program satisfaction, we assessed the 2021 virtual course format and survey data. We found that although there was a desire to return to in-person programs, the digital assets and approaches were valued. In examining the individual programmatic elements in the 2022 in-person course, there was better "value and understandability" of lectures over previous in-person years. These findings highlight how incorporating new digital engagement strategies for professional development benefits even the most established programs in supporting heterogeneous learners.

Investigating and understanding novel antibacterial agents is a necessary task as there is a constant increase in the number of multidrug-resistant bacterial species. The use of nanotechnology to combat drug-resistant bacteria is an important research area. The laboratory experiment described herein demonstrates that changes in the nanostructure of a material lead to significantly different antibacterial efficacies. Silver has been known to be an effective antibacterial agent throughout history, but its therapeutic uses are limited when present as either the bulk material or cations in solution. Silver nanoparticles (AgNPs)and DNA-templated silver nanoclusters (DNA-AgNCs) are both nanostructured silver materials that show vastly different antibacterial activities when incubated with "E. coli" in liquid culture. This work aims to provide students with hands-on experience in the synthesis and characterization of nanomaterials and basic microbiology skills; moreover, it is applicable to undergraduate and graduate curricula.

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children's lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives.

Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals (n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written material. We propose ways this interactive conversation can be documented, and the process of checking understanding improved.

Medical education continually adapts to the needs of future health care professionals, with student motivation in research being a pivotal aspect. This study at Alfaisal University aimed to explore the motivations, benefits, and challenges faced by medical students in extracurricular research activities. Using a mixed-method approach, we combined quantitative surveys with qualitative group interviews. Findings revealed that both extrinsic (e.g., enhancing postgraduate training prospects) and intrinsic (e.g., personal interest and skill refinement) factors significantly motivate students to be involved in research activities. Participants unanimously acknowledged skill enhancement, particularly in literature comprehension, creative ideation, and networking. However, challenges such as conflicts with course scheduling, lack of hands-on experiences, and mentorship issues were identified as potential barriers to research participation. Addressing these barriers and understanding motivations can inform the design of research programs, enhancing the overall student research experience. This study underscores the importance of research in medical education, emphasizing the need for institutions to prioritize addressing challenges and leveraging benefits to prepare medical students for a research-integrated clinical future.

This study explores how qualitative health researchers navigate the demands of medical research ethics committees in Germany where qualitative research is subject to approval only when it is conducted in medical contexts. We present the results of a grounded theory study to investigate qualitative health researchers' experiences with procedural ethics and the strategies they adopt to navigate its demands. Our analysis revealed six dimensions of experience and three strategies adopted by researchers to navigate the demands of medical research ethics committees. All participants agreed that research ethics is of high importance in qualitative health research, but strategies to navigate the demands of medical research ethics committees ranged from avoiding, and adapting, to transforming the procedures of ethics review. Based on our findings, we provide recommendations for improving the ethics review of qualitative health research.

Many research institutions and funders have recently stated their commitment to actively support and promote 'Equality, Diversity and Inclusion' (EDI) in various aspects of health research including Patient and Public Involvement (PPI). However, translating this commitment into specific research projects presents significant challenges that existing approaches, practical guidelines and initiatives have not adequately addressed. In this paper, we explore how the lack of clear justifications for the EDI commitment in existing guidelines inadvertently complicates the work of those involved with PPI and we stress the need for conceptual clarity for any EDI effort to yield meaningful results. Our focus centres on the first principle of the EDI discourse, 'equality', particularly in the form of 'equality of opportunity' as outlined in current guidance provided by the National Institute of Health Research in the United Kingdom. We examine challenges related to justifying and implementing a general, unspecified commitment to equality of opportunity and explain that this reflects a lack of consensus regarding the moral value of PPI in research -- a profound problem that remains unaddressed. We then discuss how the presence of several opposing moral perspectives on PPI, makes determining the most appropriate way of addressing barriers to involvement complex and controversial, raising ethical implications for the work of health researchers, PPI specialists and coordinators. Finally we make suggestions on how future research can enrich the concept of 'equality of opportunity' in PPI and improve practice. While our primary focus is on the NIHR, a strong advocate of PPI in research, this analysis will point to normative and ethical considerations that may be relevant to other research institutions and funding organisations aiming to promote equality of opportunity in their public and patient involvement strategies.

The National Institutes of Health (NIH) supports 24 IDeA Networks of Biomedical Research Excellence (INBRE) Programs that help develop university-based biomedical research capacity in states that historically receive low levels of extramural grant support. To assess the effectiveness of the Arkansas INBRE in meeting its biomedical research capacity-building goals, we evaluated how the context (i.e., local and institutional settings) at two undergraduate institutions impacted variability in science faculty use of program resources. Data were collected by in-depth interviews with faculty and administrators (N = 9), focused observations, a review of Arkansas INBRE databases, and internet searches. Content analysis was used to code interview transcripts and field notes, and then qualitative data were integrated with data from databases and internet searches to construct two institutional case summaries. Constant comparison was used to identify similarities and differences between the institutions that helped to explain variability in how frequently faculty used Arkansas INBRE resources, including an enrollment crisis at undergraduate institutions in the United States and the presence or absence of a robust research culture at each institution. These findings were used to suggest program improvements (e.g., classroom-based research) that could further strengthen biomedical research capacity in Arkansas. As some barriers to program effectiveness are likely found in other IDeA-eligible states, improvements suggested for the Arkansas INBRE could apply to INBRE programs elsewhere.

Despite the recent growth of attention to English for research publication purposes, little is known about how researchers view the role of peer review in their success of publication. In light of this gap, the present study investigated Iranian surgeons' attitudes towards peer review and the challenges they face in getting their papers published. To this end, 26 Iranian surgeons were interviewed, and the transcribed data were analyzed through thematic analysis. The results revealed that firstly the surgeons attested to the positive and negative contributions of peer review in terms of changing or unchanging their attitudes, respectively. Secondly, the authors faced a myriad of challenges related to editors, reviewers, and socio-political-linguistic factors in getting their papers published. Moreover, they associated these challenges with positive and negative effects in being connected to their career-stage development and motivating them to conduct and submit more papers. The study concludes with implications for research and practice in how researchers can craft more quality papers to enhance their chance of publication in high-quality journals.

Unlike other aspects of Obstetrics and Gynecology (OBGYN) residency training, the research education curriculum and requirements are not standardized. It is unclear what constitutes core curricula in educational research programs, which components are most useful and efficacious, and how to use these findings to adapt existing programs. A multi-phase approach to (1) garner cross-sectional data from United States OBGYN Residency Program Directors and review previously published literature, (2) use Phase I and input from clinical, research and education faculty to develop a comprehensive program, and (3) evaluate the program for resident research productivity, knowledge and satisfaction. Phase I: Sixty-one (31%) Program Directors completed the survey. Most reported [less than or equal] 4 research didactics per year and no dedicated research rotation. Programs with post graduate year (PGY) level specific didactics, a research rotation, or allocated time for the Research Director role noted higher odds of resident research resulting in peer-reviewed publication. Phase II: A Resident Research Program was adapted to include a clinical and research faculty co-directorship and seven additional didactics (all of which were PGY-specific). A departmentally funded resident research grant and a repository to monitor completion of milestones and program requirements have been developed. Surveys were used to track residents' research competence and satisfaction with the research program. While resident involvement in research activities and satisfaction with opportunities for scholarly activity have improved, resident self-evaluations and mentor evaluations have not. In addition, we have not seen an increase in publications or presentations. Implementation of components of a research program associated with increased productivity did not result in increased productivity in our program, however, resident satisfaction with scholarly activity did improve.

People are inundated with popular press reports about medical research concerning what is healthy, get advice from doctors, and hear personal anecdotes. How do people integrate conflicting anecdotal and statistical information when making medical decisions? In four experiments (N = 4126), we tested how people use conflicting information to judge the efficacy of artificial and real medical treatments. Participants read an anecdote from someone in a clinical trial, or who had undergone a medical treatment previously, for whom the medical treatment was ineffective. We found that reading anecdotes for either artificial or real medical treatments shifted participants' beliefs about the efficacy of a medical treatment. We observed this result even when the anecdote was uninformative, was paired with an icon array, or when participants were provided with thorough medical decision aids about reproductive health procedures. Our findings highlight the pervasive effect of anecdotes on medical decision making.

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design.

Kentucky ranks first in the nation in cancer incidence and mortality. The Appalachian region of the state experiences the highest cancer disparities due to inequities in many social determinants of health as well as poor health behaviors. As a strategy for addressing cancer and education disparities in the region, the Appalachian Career Training in Oncology (ACTION) Program at the University of Kentucky Markey Cancer Center engages Appalachian-native high school students in cancer education, research, and outreach activities. Entry and exit surveys were administered to participants. Classical test theory and exploratory factor analysis were used to examine the instruments used for program evaluation, whereas repeated measures ANOVA was used to determine if there were significant differences in means between entry and exit timepoints. Results demonstrated that there was an increase in students' understanding and comfort with cancer-related topics between entry and exit survey administrations. Students indicated that the program improved their research skills and career planning skills. Furthermore, students had positive perceptions of all aspects of the program.

Cancer research training programs build our future biomedical workforce. Training is often centered for students residing close to research institutions, making access more challenging for rural students. A cancer research training program was developed for high school students residing in five geographical regions across Oregon. Training was tiered in duration and intensity across the three years, including a one-week Introduction program and subsequent 10-week summer research training programs (Immersion and Intensive). A total of 60 students participated in in-person and/or virtual training, with Immersion students receiving mentored shadowing experiences in clinical care, public health, and outreach in their home communities. Laboratory rotations at a research-intensive institution enabled students to sample research environments before selecting an area of interest for Intensive training the following summer. Aligning with Self-Determination Theory, the Knight Scholars Program aims to build competence, relatedness, and autonomy of its trainees in biomedical sciences. The program exposed students to a wide range of interprofessional careers and collaborative teams, enabling scholars to envision themselves in various paths. Results show strong gains in interest and research self-efficacy for both Introduction and Immersion scholars, with findings highlighting the importance of representation within mentoring and training efforts.

The Youth Enjoy Science -Teach To Beat Cancer program funded by the National Cancer Institute utilizes the resources of the Case Western Reserve University School of Medicine and Case Comprehensive Cancer Center to provide experiences and training for grade 6-12 teachers so that they are expertly equipped to develop curricular approaches to take back to their classrooms to enhance science education, introduce concepts of cancer biology, encourage cancer risk reduction activities, foster disparity elimination and to motivate middle and high school students to pursue careers in biomedical sciences and cancer research. The program focuses on four aspects of teacher engagement and education: (1) Research Engagement, (2) Curriculum Development, (3) Risk Reduction and Disparity Elimination, and (4) Advocacy for Cancer Research and Cancer Research Careers. This program has been crucial to achieve the National Cancer Institute's goal of educating students from diverse backgrounds underrepresented in biomedical research in the Cleveland area as each teacher influences a significant number of students in their classrooms each year, and are introducing students to cancer biology, exciting them to consider careers in cancer prevention, diagnosis, control, treatment, and research. This article provides an overview of the program including its impact on the teachers and their students.

Academic health centers (AHC) both contribute to and are influenced by the communities they serve. As part of a central commitment to improving human health, there is a need for AHCs to acknowledge their history related to race and racism, the resulting impact on current health disparities, and the disparate treatment of racial and minoritized communities. As AHC's care for Black and Brown communities, they have a unique responsibility to redress their respective legacies of bias, discriminatory practices, and experimentation without consent. One way to achieve this is to provide learning opportunities for in-depth engagement with students, faculty, staff, health care providers, and community members in conversations regarding racial equity, which are essential to shaping and impacting change at an individual and institutional level. Virginia Commonwealth University in Richmond, Virginia, launched a new initiative, "History, and Health; Racial Equity," designed to (a) increase awareness of our institution's history, impact, identity, and culture, and (b) support meaningful conversations around history, health equity, structural racism, and health sciences education. Urban and metropolitan universities may learn from and replicate this program and encourage such conversations in their communities.

Over the past 20 years, there has been a significant increase in the number and complexity of clinical research studies. As a result, Clinical Research Professionals (CRPs), a workforce critical to the success of clinical research, have seen commensurate increases in workload and responsibilities. Unfortunately, there has not been a parallel increase in the 'professionalization' of CRPs, and the lack of professional recognition and career development opportunities remain primary motivators for voluntary turnover in this workforce. The development of the Joint Task Force (JTF) Core Competency Framework (2014) was a seminal step in addressing these issues and has changed the dialogue within the clinical research enterprise from a focus on regulatory compliance to one of professional competency. Encouraged by peers in academic health science centres in the United States, the Hospital for Sick Children (SickKids) in Toronto, Canada undertook an initiative to adapt the JTF Framework to suit the Canadian context as well as incorporate the unique scientific and ethical considerations pertinent in child health research. The SickKids Clinical Research Competency Framework (SickKids CR-CF) is being used to support the professionalization of the local CRP workforce through (1) a standardized onboarding and orientation program for new hires; (2) creation of a novel, competency-based clinical research curriculum; (3) development of tools and processes to leverage the framework for professional development and career progression; and (4) job roles that are descriptive of the required competencies. The overall aim of such initiatives is to help increase participant safety, research quality and regulatory compliance as well as improve job satisfaction and institutional engagement among our clinical research workforce at SickKids.

To initiate clinical research studies successfully and efficiently, it is critical to develop a strong, feasible, and well-written study protocol early in the start-up phase. The University of Minnesota's Clinical Research Support Center designed and implemented a structured Feasibility Review process in 2018 that addresses common start-up challenges such as poor study design, inappropriate outcomes, and limited resources. This process has been shown to turn an unfeasible study into a well-designed protocol that is IRB-approved with few protocol-related stipulations and well prepared for execution. It has also educated study teams on how to write better-quality and more robust protocols for subsequent studies. Once a draft protocol is available, the entire process takes just six working days and is free of charge to investigators, study teams, and departments. From 2018-2021, one hundred sixteen Feasibility Reviews (n=116) have been completed across eight schools or colleges. Mean satisfaction scores for study team members who responded were high (N=126, M=4.71 ± 0.5) on a 5-point Likert-type scale. Most respondents (96%) indicated that they planned to modify their protocol based on reviewer feedback. Open ended/ qualitative feedback was highly positive with most responses centered around the helpfulness of feasibility review, the high level of expertise, and fast turnaround time. The Feasibility Review is a valuable and multifunctional program providing timely expert guidance to study teams to efficiently and successfully launch and execute clinical research studies. It can be easily replicated, adapted, and implemented at other institutions to increase the quality and efficacy of academic research.

The practice of prospectively registering the details of intervention studies in a public database or registry is gaining momentum across disciplines as a strategy for increasing the transparency, credibility, and accessibility of study findings. In this article, we consider five registries that may be relevant for registration of intervention studies in the field of prevention science: ClinicalTrials.gov, the American Economic Association Registry of Randomized Controlled Trials (AEA RCT Registry), the Open Science Framework Preregistration (OSF Preregistration), the Registry for International Development Impact Evaluations (RIDIE), and the Registry of Efficacy and Effectiveness Studies (REES). We examine the five registries in terms of substantive focus, study designs, and contents of registry entries. We consider two paths forward for prospective registration of intervention studies in the field of prevention science: Path A: register all studies in ClinicalTrials.gov and Path B: allow individual researchers to select the registry with the "best fit." Lastly, we consider how the field might begin to establish norms around registration. [This article was published in "Prevention Science" (EJ1341830).]

Background: Dissociative Trance Disorder (DTD), is a complex psychological condition characterized by abrupt trance-like states and altered consciousness, commonly seen in young women throughout various regions of India. Currently, there is a lack of research on the experiences of Indian adolescent girls with DTD and how inaccurate medical information affects their quest for suitable care. This study aims to develop a thorough comprehension of the help-seeking patterns and experiences of adolescent girls with DTD, specifically concerning encountering medical misinformation. By identifying the obstacles, they face and the cultural beliefs that shape their decision-making, this research seeks to guide interventions and initiatives aimed at enhancing care and support for this group. Method: Six adolescent girls and young women, who sought therapy at a district hospital in Sikkim were recruited for the study. They were interviewed extensively and their interview data were transcribed verbatim and analyzed using interpretative phenomenological analysis. Result: Three super-ordinate themes that emerged were: challenges in seeking diagnosis and treatment; emotional and psychological struggles; support and healing journey. Conclusion: Misinformation surrounding DTD in India impacts the help-seeking behaviours of adolescent girls, leading to delays in diagnosis and inadequate treatment. Cultural beliefs, reliance on exorcism, and insufficient healthcare professional training contribute to this problem. Awareness campaigns are necessary to correct misconceptions and misinformation and promote accurate understanding among parents, communities, and healthcare providers. Culturally sensitive approaches, accurate information dissemination, and collaboration among stakeholders are crucial for improving care and support for individuals affected by DTD in India. Additionally, it is acknowledged that certain religious beliefs resist empirical evidence, but it is vital to recognize that not all religious beliefs are misinformation solely based on scientific evidence. As we address the impact of cultural beliefs, it is essential to strike a balance between respecting individual faith and promoting evidence-based interventions.

In response to the SARS-CoV-2 pandemic, a cancer research education program at the University of Nebraska Medical Center designed for Native American middle school, high school and undergraduate students adapted activities to be delivered online. There are considerable challenges to adapting in-person science programming to online delivery that can impact overall effectiveness. These challenges are further exacerbated when the cognate student population also faces significant disparities in health, wealth, and educational outcomes. We encountered both disadvantages and advantages in transitioning programming to online virtual formats. Challenges faced in delivering our programming during the pandemic included varied online accessibility, peripheral stressors, and disconnection to places and people. Despite these challenges, we found several benefits in remote delivery, some of which have alleviated barriers to program participation for Native American students. Some successes achieved by transitioning to fully remote programming included increased program reach, sustainability, and cultural relevancy. In this overview of the implementation of four online programs at the middle school, high school, and undergraduate levels, we highlight the challenges and successes experienced. Through this program description, we aim to provide insight into potential strategies to improve program delivery designed for Native American students during the SARS-CoV-2 pandemic and beyond.

Simulated standardized patients (SPs) are trained individuals who pose incognito as people seeking treatment in a health care setting. With the method's increasing use and popularity, we propose some standards to adapt the method to contextual considerations of feasibility, and we discuss current issues with the SP method and the experience of consent and ethical research in international SP studies. Since a foundational discussion of the research ethics of the method was published in 2012, a growing number of studies have implemented this method to collect data on the quality of care in a variety of settings around the world. We draw from that experience to provide empirical foundations for a popular approach to ethical approval of such studies in the United States and Canada, which has been to obtain a waiver of informed consent from the health care providers who are the subjects of the research. However, the majority of studies to date have evaluated quality of care outside the U.S., requiring additional ethical consideration when partnering with international institutions. We discuss these considerations in the context of a case study from a completed SP study in South Africa, where informed consent is constitutionally protected.

The current system of ethical oversight in the United States is based on Institutional Review Board (IRB) review. The system was established in response to well-known and egregious mistreatment of subjects in both biomedical and social and behavioral research. In the decades since the research regulations were enacted, reaction to the burden of IRB oversight has led the system to focus on compliance and limit its active oversight disproportionately to studies that could present the risk of physical harm. At the same time, the characteristics of the research enterprise have changed and methodologies now present novel risks that were not envisioned in the regulations. We convened a group of IRB professionals, academic leaders, and others to discuss limitations of the current system, how that system could be changed to recognize evolving risks and an increasing focus on participant and community voice, and how it could better serve the needs of researchers and support the societal project of science as a public good. Recommendations included a call to reexamine the academic incentive structure, to develop a system to support consideration of ethical principles from the time of study design, and to explicitly provide different ethical support and oversight for high-risk interventional trials and lower risk biomedical and social behavioral research.

This note is concerned with evaluation of location parameters for polytomous items in multiple-component measuring instruments. A point and interval estimation procedure for these parameters is outlined that is developed within the framework of latent variable modeling. The method permits educational, behavioral, biomedical, and marketing researchers to quantify important aspects of the functioning of items with ordered multiple response options, which follow the popular graded response model. The procedure is routinely and readily applicable in empirical studies using widely circulated software and is illustrated with empirical data.

This research seeks to describe the continuing predicament of R&D funding in the U.S. and to provide support for a return to higher R&D spending as a proportion of GDP to maintain American leadership in innovation. Historically, government investment has funded most foundational scientific research leading to technological advances in communications, recording, and networks, including global positioning systems to the Internet. The U.S. has been leading in research and development. However, that investment leadership position is in question due to declining proportionate government support for R&D. The R&D function in private enterprise is ill-equipped to support long-term innovation, which will reward competitors. Past and current research evidence shows that public R&D investment leads private investment and furthers the strategic goals of innovation and economic growth. The COVID-19 pandemic led to unprecedented public research commitments to the rapid development of drugs, vaccines, and various protective and medical equipment. The long-term impact of this public investment on innovation is not clear. According to some theories, the trend of declining U.S. public investment in R&D will negatively impact U.S. economic growth.

Research experience provides critical training for new biomedical research scientists. Students from underrepresented populations studying science, technology, engineering, and mathematics (STEM) are increasingly recruited into research pathways to diversify STEM fields. However, support structures outside of research settings designed to help these students navigate biomedical research pathways are not always available; nor are program support components outside the context of laboratory technical skills training and formal mentorship well understood. This study leveraged a multi-institutional research training program, Enhancing Cross-Disciplinary Infrastructure and Training at Oregon (EXITO), to explore how nine institutions designed a new curricular structure (Enrichment) to meet a common goal of enhancing undergraduate research training and student success. EXITO undergraduates participated in a comprehensive, 3-year research training program with the Enrichment component offered across nine sites: three universities and six community colleges, highly diverse in size, demographics, and location. Sites' approaches to supporting students in the training program were studied over a 30-month period. All sites independently created their own nonformal curricular structures, implemented interprofessionally via facilitated peer groups. Site data describing design and implementation were thematically coded to identify essential programmatic components across sites, with student feedback used to triangulate findings. Enrichment offered students time to critically reflect on their interests, experiences, and identities in research; network with peers and professionals; and support negotiation of hidden and implicit curricula. Students reported the low-pressure setting and student-centered curriculum balanced the high demands associated with academics and research. Core curricular themes described Enrichment as fostering a sense of community among students, exposing students to career paths and skills, and supporting development of students' professional identities. The non-formal, interprofessional curricula enabled students to model diverse biomedical identities and pathways for each other while informing institutional structures to improve diverse undergraduate students' success in academia and research.

Progress in precision medicine is being achieved through the design of clinical trials that use genetic biomarkers to guide stratification of patients and assignation to treatment or control groups. Genetic analysis of biomarkers is, therefore, essential to complete their objectives, and this involves the study of biological samples from donor patients that have been recruited according to criteria previously established in the design of the clinical trial. Nevertheless, it is becoming very common that, in the solicitation of biological samples, purposes that are beyond the objectives of the stated therapeutic trial research are introduced, like the development of ill-explained exploratory studies or the use in unspecified future research. In the digital era, the sequencing of patients' DNA needs to be considered as a serious security matter, not only for the patients, but also for their relatives. Genetic information may be easily stored, even forever, in digital files. This engenders a permanent risk of being stolen or misused in many ways. Furthermore, re-identification of sample donors is technically feasible through their genetic data. For these reasons, genetic analysis of samples collected in clinical trials should be restricted to the accomplishment of their main objectives or well justified goals.

As the burden of misconduct in medical research is increasingly recognised, questions have been raised about how best to address this problem. Whilst there are existing mechanisms for the investigation and management of misconduct in medical literature, they are inadequate to deal with the magnitude of the problem. Journal editors and publishers play an essential role in protecting the veracity of the medical literature. Whilst ethical guidance for journal editors and publishers is important, it is not as readily enforceable as legal obligations might be. This article questions the legal obligations that might exist for journal editors and publishing companies with respect to ensuring the veracity of the published literature. Ultimately, there is no enforceable legal obligation in Australia, the United Kingdom, or the United States. In light of this, more robust mechanisms are needed to deliver greater confidence and transparency in the investigative process, the management of concerns or findings of misconduct and the need to cleanse the literature. We show that the law disincentivises journals and publishers from ensuring truth in their publications. There are harmful consequences for medical care and public confidence in the medical profession and health care system when the foundations of medical science are questionable.

Biostatisticians apply statistical methods to solve problems in the biological sciences. Successful practioners of biostatistics have advanced technical knowledge, are skilled communicators, and can seamlesslessly integrate with interdisciplinary scientific teams. Despite the breadth of skills required for success in this field, most biostatistics education programs place heavier emphasis on development of technical skills than skills necessary for collaborative work, including critical thinking, writing, and public speaking. Our master's degree program in biostatistics aims for stronger integration of education in collaborative work alongside development of technical knowledge in biostatistics. Toward that end, we propose a model that provides students with a mental map for practicing biostatistics, and that can serve as a tool for faculty to create hands-on learning experiences for biostatistics students. The model helps students organize their knowledge of biostatistics, unifying the technical and collaborative aspects of the discipline in a single framework that can be applied across the broad array of activities that biostatisticians engage in. In this article we describe the model in detail and provide an initial assessment of whether the model might meet its intended purpose by applying the model to a common task for practicing biostatisticians and biostatistics students: describing the results of a medical research study.

The landscape of clinical research is continuously evolving, focusing now on the scientific assessment of efficacy balanced with patient safety, along with advancements in technology and informatics. These considerations necessitate the acquisition and retention of experienced staff that will be able to meet the demands associated with these new focus areas and can provide support for administrative duties, regulatory duties, study participant management, and data collection at individual research sites. Furthermore, the identification of Clinical Trials Administrators that can function independently and collaboratively within a large, integrated healthcare system clinical research consortium can be a challenging task. Currently, there is a limited amount of publicly available information on strategies that have been employed to identify these types of candidates in this type of setting. The primary aim of this project was to determine if the development of a virtual interview panel, or Manager Interview Panel (MIP), would be effective in screening, interviewing, and ranking applicants for a vacant Associate Director-- Operations (ADO) position at one of the Node sites in our clinical research consortium. The findings may inform individuals or groups in research administration and leadership roles seeking to improve the candidate selection component of their respective hiring processes, particularly for those groups that are a part of clinical research consortiums and have study sites that are geographically dispersed and not in close proximity to one another.

In the study of Islamic education, the scientific and medical contributions of Muslims globally are incongruously positioned. In most cases, Islamic education is completely divorced from its conventional scientific research and experimentation known and appreciated in its early and classical periods. Science and medicine are not alien in Islamic epistemology, though, have suffered gross neglect in the Muslim World in recent centuries. However, the universality and connectivity among the Muslims in the world since the beginning of the Islamic mission has been one of the gluing and cementing factors in the Muslim world intellectually and culturally, which made spread and diffusion of literature and scholarship across Muslim communities reciprocally. It is thus, not a surprise to find that, not only on the spiritual and educational facets but also in scientific and medical spheres the classical writers of the Middle Eastern and Mediterranean regions got their ways and significantly impacted the Muslim scholars of the nineteenth century northern Nigeria. The paper, therefore, aims at tracing and analyzing the extent of influence of those (Middle Eastern and Mediterranean regions) scientific literatures on the perception, motivation, as well as research, documentation, and experimentation in fields of sciences and medicine in Muslim Northern Nigeria. Special consideration will be given to the works by Sultan Muhammad Bello, d. 1837, who wrote quite a number of treatises on different aspects of sciences, followed by Sheikh Abdullahi Fodiyo d. 1829, and others who followed after them. The research will also explore how in turn, their educational works on scientific and medical research also impacted on the Muslim societies in Nigeria and beyond, especially in the codification and enlistment of the scientific resource materials on the wider educational spheres and the curricular of the Muslim societies of the area, since the last two centuries.

Citation is an essential part of academic writing and allows writers to make strong arguments, review previous research, and express their opinions. This study investigates reporting verbs as a part of citation practice in the research articles published in Iranian and international journals (with different linguacultural backgrounds) in humanities and medical sciences from 2015-2019. In this cross-disciplinary study, 60 research articles (RAs) from Applied Linguistic (AL) and Nursing and Midwifery (NM) as part of humanities and medical sciences respectively were selected and classified based on Hyland's (2002) frameworks. The results demonstrated that the Iranian journal articles utilised more reporting verbs (RVs) than the international journal articles whereas, the international articles used RVs with a wide variety. Although the types of verbs were different, the research verbs had a clear preference in the corpus. The finding suggests some pedagogical implications for novice scholars and EFL (English as a Foreign Language) students to become familiar with differences in using RVs and select the correct choice of reporting verbs in the field of humanities and medical sciences.

This study is a corpus-based investigation of how epistemic stance is signaled in medical discourse. In particular, we compiled a discipline-specific corpus of research articles from different fields of medicine ranging from anatomy to endocrinology to explore how particular resources are employed by authors to index their level of (un)certainty towards their propositions. The corpus of the study contained only the results and discussion sections of 100 published medical research articles, totaling approximately 215,000 words. The results of the corpus analyses showed that there was very frequent use of modal auxiliaries by the writers in the field of medicine to express their extra-propositional modality. It was also found that medical researchers did not employ a greater number of boosters to amplify their commitment to the propositions conveyed to the readers. However, the rhetorical uses of boosters were shown to be strategic to portray their higher level of confidence for the sake of credibility and interaction. The findings and implications are discussed with a particular focus on the teaching of writing as a part of English for academic purposes.

Medicine is a science dealing with uncertainty and the art of judging probability. For effective communication, doctors, researchers, or health sciences writers, need to master the use of modality whereby unreal situations can be discussed. How modal verbs -- the most commonly used type of modality applied in the writing of health and medical sciences -- are used in general English can differ from scientific contexts, and within different scientific fields a modal verb may not be used in the same way. This study aims to analyze the use of modal verbs in the abstracts of medical articles published in the past 5 years to enable researchers or medical writers to select the most suitable linguistic devices for their contexts. Modals were discovered to function variously in different parts of medical abstracts, with the highest number in the final part of the abstract structure. In the majority of the abstracts analyzed, usage was found not to be speculation on the part of the author but rather to address the evidence and circumstances. Modals were also found to be context-based and relate to the choices of the tense, voice, reality status, and situation type. The findings can benefit scientific writers and provide EAP, ESP, and EST instructors material for communicative practice.

Japan's operating budget for its national universities has been reduced since 2004 year by year, leaving a tight competition among universities in securing research funding. Urban universities with several prominent researchers can operate by securing competitive funding, joint research with companies, and donations, whereas small rural universities struggle with finances. How should small rural universities survive in the future? The vision and mission of Hamamatsu University School of Medicine (HUSM), a rural medical college, is to play a central role in the local community medicine through medical photonics research and academia-industry-government collaboration. HUSM is a member of the regional industrial cluster, and research administrators (RAs) have promoted the medical photonics filed through activities such as education, matching, funding, research and development support, technology transfer, and sales promotion support to make the university distinctive. RAs collaborate with universities, companies, and local governments in the same region to conduct joint research and commercialize products as though these units were a single organization. As a result, the number of joint research projects and the amount of revenue from joint research have increased every year. The government has recognized this unique approach. Furthermore, university consolidation is being pursued as a cost-saving measure to increase the money spent on research. Consolidation can strengthen the ability of university research, and can result in more joint research with companies and more research funding.

A multi-centre clinical trial involves the implementation of the same clinical protocol at several independent investigational centres. Multi-centre clinical trials may be preferable to single-centre trials, but their implementation and management is more complex. EU-funded collaborative projects involve several participating organizations and countries and their consortia are typically multidisciplinary. Their coordination requires a joint effort from several actors, and an appropriate managerial structure and procedures need to be defined and established. The management of the Framework Programme 7 (FP7) PREVIEW project, whose core consisted of a clinical trial with 8 intervention centres/sites is presented as case study. PREVIEW was coordinated by the University of Copenhagen. The project management was implemented by a combination of decentralised project management, at the department level, jointly by the Project Coordinator (PC) and Project Manager (PM), and centralised, by a dedicated EU Liaison Officer from the Project Management Office (PMO). The Quality Manager role was undertaken by the PC, with support from selected consortium members. The Exploitation Manager role was assumed by the leader of the dissemination and exploitation work package. The Data Manager (DM) at the University of Copenhagen established and maintained a datahub for all data from the clinical trial. The General Assembly and Steering Committee were key decision bodies with regard to taking and implementing decisions. The Scientific Advisory Board (SAB) was formed by reputed external experts providing guidance and advice. The project website was the main channel to reach the general public. A password protected private section was used as internal repository for the project. Regular meetings at all levels were key to ensure good communication and collaboration among the project team. Appropriate attention to data management was given from the start. The privacy of personal data was ensured in accordance with national and EU regulations. The PC was also the Sponsor of the multicentre clinical trial, and the PM served as the overall Clinical Trial Administrator. Each centre was led by a Principal Investigator (PI), running the trial together with the local daily responsible. The tasks and responsibilities for the clinical trial of the Coordinating Centre were shared between Copenhagen and Helsinki centres. The trial was overall led by the Clinical Trial Manager (CTM), who was the PI at the Helsinki centre. The local Independent Ethical Committees approved the protocol prior to the start of the intervention. One member of the SAB acted as Ethical Officer. The trial/study had an overall statistician. The Analyst role was shared among different people from the Copenhagen and Helsinki centres. The DM created and maintained database for the intervention and the Clinical Report Forms by using OpenClinica open source software. The staff in the intervention received training in Good Clinical Practices, the protocol and its procedures. The monitoring tasks were jointly undertaken by the Sponsor and the CTM. The documents from the Trial Master File were saved in the Internal Repository. A set of Standard Operation Procedures was defined. Meetings among all PIs, and within the Instructors' Network were key in the success of the intervention. This case study aims at serving as guidance to coordinating researchers, both during the proposal preparation and project implementation phases, as well as to provide visibility and insight into the multi-faceted role of the project managers and administrators of such projects.

Background: The peer review of clinical research projects is an essential step in project preparation. While some projects undergo rigorous review by grant-giving organizations, this does not apply to all clinical research. In many cases, peer review, if undertaken at all, is not rigorous, fully independent, or timely. Depending on their department or institution, many researchers do not have easy access to such review. This can result in delay to ethical and institutional approval, and uncertainty about the quality of individual projects. Methods: After a two-year pilot study the Peer Review Service (PRS) was established at Imperial College, London in 2009. The aim was to provide an easily accessible and quick service for researchers at all the clinical sites associated with Imperial College. A graded system of review levels was designed which used an algorithm to match the independence and robustness of the review to the ethical weight of each project. The levels ranged from 1--internal review by a supervisor to 5--fully independent review by at least two external individuals. A semi-structured response form for reviewers was generated to facilitate the review process and ensure that all relevant aspects were considered. For each reviewed project, the PRS issued a certificate confirming the quality of the review. Outcomes: There was a gradual increase in use of the service from the 2009 inception. From January to June 2020, 63 projects underwent peer review commissioned by the service. This represented all of the clinical research projects performed at Imperial sites that required review. The mean time from application to delivery of review was 1.73 weeks. Administrators found the algorithm for determining the peer review level easy to use, occasional queries being managed by members of the supervising committee. Audits demonstrated that researchers, reviewers and ethics committees were satisfied with the service. Conclusion: A proportionate system of peer review for clinical research projects works well. It produces appropriately robust and independent reviews and can be implemented easily by administrative staff. Close association of a peer review service with university research administration ensures that all projects needing peer review receive it. The centralized service assists researchers in obtaining reviews speedily. This simple model could be used widely by other clinical research centres.

The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.

Several authors have described how the formalization of recent decades has steered doctoral education towards structured curricula, more managerial control and new models for supervision. Largely absent from these accounts, however, is if and how doctoral education has been affected by the concurrent changes in research governance, in particular by the 'projectification' of research. For this study, we were interested in the convergence of educational formalization with research projectification around doctoral education in the context of highly competitive, externally funded research in medicine and health sciences in Sweden. Using Cultural-historical activity theory and constructing activity systems for education and research, respectively, we were able to identify several contradictions and tensions, both within and between systems, that were consequences of adaptations to the abovementioned formalization and research policy changes. The contradictions were manifested in the tying of doctoral students, and their education, to their supervisors' research projects, grants and future prospects, and in students being deprived of opportunities for learning and developing independence. Supervisors were torn between supervision and project management while doctoral students had to balance being students and project members. Our analysis provides a system level explanation to previously reported pedagogical and ethical challenges in STEM doctoral education.

Gene therapy has fascinated clinicians, scientists, and patients since decades ago because of its potential to treat a disease at the genetic level. This can be achieved in many ways, including replacing a disease-causing gene with a healthy copy. Gene therapy must overcome complex tissue and cellular barriers to introduce genetic modifications into the nucleus of the target cells to drive a high level of gene expression. Moreover, the genetically corrected cells must be present in significantly large numbers in the body to reverse the diseased condition and yet able to escape immunological recognition and survive in the long term to sustain the benefit. This paper reviews the early work as well as recent developments in gene therapy, including improvements to viral vectors and novel treatment strategies, diseases targeted, approved gene therapies, and current challenges and prospects for future progress.

STEM-related educational outreach offers students enriching opportunities to become more familiar with science, in terms of how it relates to their daily lives and with respect to possible career paths that they might want to follow. At the same time, graduate student trainees providing that outreach act as important resources for elementary and high school teachers while they hone their teaching skills and build confidence in the classroom. In this paper, six graduate students and recent graduates share their experiences with a variety of outreach programs that link young people with science in both Canada and the United States.

Employee performance is a critical factor in the success, or failure, of any organization. Therefore, it is paramount that the leadership and/or management team in an organization establishes and implements an approach that can effectively assess and evaluate the performance of its employees in an objective manner. Research administrators are often involved with the performance evaluation process at their respective institutions. However, there is a limited amount of publicly available information on the use of work performance and assessment methods in research settings. The primary aim of this pilot project was to establish a structured performance-based assessment tool that would allow for an objective and clearly articulated evaluation of staff performance at our clinical research center. The secondary aim was to determine if a structured performance-based assessment tool would improve staff satisfaction with the Center's overall performance evaluation process (PEP). A baseline survey was conducted to examine employee perspectives of and satisfaction with the current performance evaluation process. A follow-up survey was conducted after the mid-year performance review period and implementation of the new PEP, including goals templates and performance evaluation guidance documents. The results of the baseline survey showed that staff had mixed reviews of the overall performance evaluation process (somewhat satisfied-33%, very dissatisfied, dissatisfied, neutral, satisfied -all 16%) and all thought the evaluation criteria could be improved (100%). The results of the followup survey showed that staff reviews of the overall mid-year performance evaluation process had improved (63% satisfied, 12% very satisfied, 25% somewhat satisfied) and that 50% of respondents were satisfied with the ease of use and clarity of the templates that were used to record their progress towards achieving their goals. Staff shared additional suggestions for strengthening and better aligning the templates with Center-specific roles and activities. Overall, the leadership/management team at our research Center was successful in creating a performance-based assessment approach that facilitated a more objective and clearly articulated evaluation of staff performance. There are numerous challenges to effectively evaluating staff performance in both research and non-research organizations. As a result, the strategies outlined here may be transferable to other types of work settings.