Search

The aim of this study is to profile academic institutions (n = 127) based on publications, citations in the top 10% of journals, patent citations in Food and Drug Administration (FDA) approvals, clinical trials with uploaded results, contributions to clinical practice guidelines, awarded patents, start-ups, and licenses generating income in response to the Association of University Technology Managers (AUTM) Licensing Activity Survey: Fiscal Years 2011-2015. Latent variable modeling (LVM) was conducted in Mplus v.8.1, specifically latent profile analysis (LPA) was utilized to predict institutional profiles of research, which were compared with the 2015 Carnegie Classification System ranks. Multivariate regression of profile assignment on research expenditure and income generated by licensure was used to show concurrent validity. The LPA resulted in three profiles as the most parsimonious model. Mantel-Haenszel test of trend to the Carnegie Classification found a positive and significant association among institution rankings (r = 0.492, X[superscript 2](1) = 26.69, p < 0.001). Profile assignment significantly predicted differences in research expenditure and income generated by licensure. By classifying academic institutions into improving, mobilizing and thriving translational research profiles allows for a universal metric of translation of science from basic or bench to practice or policy.

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.

Component network meta-analysis (CNMA) compares treatments comprising multiple components and estimates the effects of individual components. For network meta-analysis, a standard network plot with nodes for treatments and edges for direct comparisons between treatments is drawn to visualize the evidence structure and the connections between treatments. However, the standard network plot does not effectively illustrate the connections between components for a CNMA. For example, the comparison between linear combinations of components within a trial is not shown directly in a standard network plot, and whether all components are identifiable cannot be deduced directly from the plot. Therefore, we need a new approach to visualizing the evidence structure of a CNMA. In this article, we proposed a new graph, a modified signal-flow graph representing a system of equations, to evaluate the evidence structure for CNMA. In our new graph, each node represents a component, and arrows are used to show linear relationships between components. We used two examples to demonstrate how to draw and interpret the graph and how to use it to identify components that require more evidence.

We examine four important considerations in the development of covariate adjustment methodologies for indirect treatment comparisons. First, we consider potential advantages of weighting versus outcome modeling, placing focus on bias-robustness. Second, we outline why model-based extrapolation may be required and useful, in the specific context of indirect treatment comparisons with limited overlap. Third, we describe challenges for covariate adjustment based on data-adaptive outcome modeling. Finally, we offer further perspectives on the promise of doubly robust covariate adjustment frameworks.

Reference intervals, or reference ranges, aid medical decision-making by containing a pre-specified proportion (e.g., 95%) of the measurements in a representative healthy population. We recently proposed three approaches for estimating a reference interval from a meta-analysis based on a random effects model: a frequentist approach, a Bayesian posterior predictive interval, and an empirical approach. Because the Bayesian posterior predictive interval becomes wider to incorporate estimation uncertainty, it may systematically contain greater than 95% of measurements when the number of studies is small or the between study heterogeneity is large. The frequentist and empirical approaches also captured a median of less than 95% of measurements in this setting, and 95% confidence or credible intervals for the reference interval limits were not developed. In this update, we describe how one can instead use Bayesian methods to summarize the appropriate quantiles (e.g., 2.5th and 97.5th) of the marginal distribution of individuals across studies and construct a credible interval describing the estimation uncertainty in the lower and upper limits of the reference interval. We demonstrate through simulations that this method performs well in capturing 95% of values from the marginal distribution and maintains a median coverage of near 95% of the marginal distribution even when the number of studies is small, or the between-study heterogeneity is large. We also compare the results of this method to those obtained from the three previously proposed methods in the original case study of the meta-analysis of frontal subjective postural vertical measurements.

Although several entrepreneurship education programs (EEPs) have been created for faculty, research examining women faculty experiences participating in EEPs is minimal and particularly negligible in the context of their academic research. To address this gap, we examine women faculty's perceptions and experiences toward EEPs in the context of biomedical (BM) research. The research question examined is as follows: how do women faculty with a BM research focus experience and/or perceive EEPs? Eight self-identified women faculty who pursue B.M. research participated in in-depth interviews for this study. The data analysis drew on phenomenological experience-based qualitative research methodologies. Three key themes emerged with respect to participant experiences with and perceptions of EEPs: (1) engaging in customer discovery, (2) navigating the entrepreneurial program, and (3) facing BM specific research challenges. Customer discovery was identified as the most impactful outcome, and it pushed the faculty to explore the impact of their innovations beyond their laboratory spaces; however, the customer discovery process was challenging due to the complexity of the BM environment. Furthermore, several challenges were noted when navigating the program concerning feedback delivery and students' roles. Lastly, several BM-specific challenges were raised, specific to the lack of disciplinary diversity and post-EEP guidance on regulatory approvals and funding. We anticipate that these research-based findings will inform the continued development of EEPs that are inclusive of women STEM faculty, particularly those who are engaged in BM research. Implications for research and practice are presented in the context of the emergent findings.

Offering high school students' exposure to university level laboratory research encourages interest in science, develops critical thinking, and prepares the new generation for college and careers. In this study, we report on the development of an immersive 2-week summer camp with the aim of training high school students in cancer research. Carefully selected laboratory methods were chosen to yield distinct visible results with the sole goal of making complex concepts more accessible and engaging to high school students. The 20 participants were randomly selected from a bigger pool of candidates without any prior registration requirements, such as grades or prior lab experience. Survey questionnaires given to students on the first day of the program outlined the background of each student and helped the instructors to better understand their goals and expectations. The postcamp survey, which measured satisfaction and potential areas for improvement, was completed by students after their departure from the campus and served as an unbiased evaluation of our program. Considering the feedback from students, our program was very successful. Whereas information for such programs is not broadly available, research laboratories and future summer camps that aim to train high school or undergraduate students with minimal laboratory experience may utilize this pedagogy as a template for their programs.

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.

Matching-adjusted indirect comparison (MAIC) enables indirect comparisons of interventions across separate studies when individual patient-level data (IPD) are available for only one study. Due to its similarity with propensity score weighting, it has been speculated that MAIC can be combined with outcome regression models in the spirit of augmented inverse probability weighting estimators to improve robustness and efficiency. We show that MAIC enjoys intrinsic double-robustness and semiparametric efficiency properties for estimating the average treatment effect on the treated in the limited IPD setting without explicit augmentation. A connection between MAIC and the method of simulated treatment comparisons is highlighted. These results clarify conditions under which MAIC is consistent and efficient, informing appropriate application and interpretation of MAIC analyses.

Outputs from living evidence syntheses projects have been used widely during the pandemic by guideline developers to form evidence-based recommendations. However, the needs of different stakeholders cannot be accommodated by solely providing pre-defined non amendable numerical summaries. Stakeholders also need to understand the data and perform their own exploratory analyses. This requires resources, time, statistical expertise, software knowledge as well as relevant clinical expertise to avoid spurious conclusions. To assist them, we created the "metaCOVID" application which, based on automation processes, facilitates the fast exploration of the data and the conduct of sub-analyses tailored to end-users needs. "metaCOVID" has been created in R and is freely available as an R-Shiny application. Based on the COVID-NMA platform (https://covid-nma.com/) the application conducts living meta-analyses of randomized controlled trials related to COVID-19 treatments and vaccines for several outcomes. Several options are available for subgroup and sensitivity analyses. The results are presented in downloadable forest plots. We illustrate "metaCOVID" through three examples involving well-known treatments and vaccines for COVID-19. The application is freely available from https://covid-nma.com/metacovid/.

According to national labor market information study, access to talent is the greatest business challenge Canadian biotech companies are facing. We, therefore, developed, implemented, and assessed a pharma industry-inspired, medicinal research laboratory module in an experiential capstone biotechnology laboratory course. This involves developing a 12-week semester-long graduate laboratory module, introducing the students to the biotechniques in microbiomics, genomics, proteomics, enzyme kinetics, drug screening, and bioinformatics, with accompanying class and lab participation (discussion forum), lab reports, and team-based assignments. The course was taught both as interactive in-person and as synchronous virtual classroom sessions. The success of the offered pedagogy was established by the laboratory exit survey and the evaluation of students' performance in various course elements and activities. The survey responses and students' performance in the course imply that the course furthered an in-depth knowledge of both industry-focused techniques and the theory behind them, as well as a genuine excitement for medical research. The skillsets honed by these laboratories will better prepare biotechnology graduates in undertaking scientific investigation for their careers in a field where there is a chronic biotech skill shortage. Students performed well and had a high overall perception of the course.

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.

Contextual factors such as cultural values and traditions impact on implementation processes of healthcare interventions. It is one of the reasons why local stakeholders may decide to role out a programme differently from how it has originally been developed or described in scientific literature. This can result in different but most likely more context-specific outcomes. Systematic reviews are considered important in answering what works, for whom and in which circumstances. They often include a section on implications for policymakers and practitioners, in which they discuss relevant options to engage with. Implementation sections are coloured by the cultural background, theoretical and disciplinary perspective of the reviewers formulating them. They do not necessarily consider local contexts in which the evidence needs to be applied, hence the recommendations may be too general to be useful. When policy makers and practitioners implement systematic review findings the evidence presented needs to be translated to their local context. We propose CONSENSYS, an instrument that facilitates the transfer from review evidence into practice. CONSENSYS contains 52 contextual factors categorised as either of ecological and socio-cultural relevance or pitched as influencing actor. CONSENSYS is relevant for reviewers because it supports them in structuring and formulating context-sensitive implications sections. It may also guide end-users of systematic reviews in translating review evidence for use in local policies and practices. CONSENSYS is the first rigorously developed instrument that focusses on implications for policy and practice sections in systematic reviews.

The number of clinical prediction models sharing the same prediction task has increased in the medical literature. However, evidence synthesis methodologies that use the results of these prediction models have not been sufficiently studied, particularly in the context of meta-analysis settings where only summary statistics are available. In particular, we consider the following situation: we want to predict an outcome Y, that is not included in our current data, while the covariate data are fully available. In addition, the summary statistics from prior studies, which share the same prediction task (i.e., the prediction of Y), are available. This study introduces a new method for synthesizing the summary results of binary prediction models reported in the prior studies using a linear predictor under a distributional assumption between the current and prior studies. The method provides an integrated predictor combining all predictors reported in the prior studies with weights. The vector of the weights is designed to achieve the hypothetical improvement of area under the receiver operating characteristic curve (AUC) on the current available data under a practical situation where there are different sets of covariates in the prior studies. We observe a counterintuitive aspect in typical situations where a part of weight components in the proposed method becomes negative. It implies that flipping the sign of the prediction results reported in each individual study would improve the overall prediction performance. Finally, numerical and real-world data analysis were conducted and showed that our method outperformed conventional methods in terms of AUC.

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.

Purpose: This research note illustrates the effects of video data with nonsquare pixels on the pixel-based measures obtained from videofluoroscopic swallow studies (VFSS). Method: Six pixel-based distance and area measures were obtained from two different videoflouroscopic study units; both yielding videos with nonsquare pixels with different pixel aspect ratios (PARs). The swallowing measures were obtained from the original VFSS videos and from the videos after their pixels were squared. Results: The results demonstrated significant multivariate effects both in video type (original vs. squared) and in the interaction between video type and sample (two video recordings of different patients, different PARs, and opposing tilt angles of the external reference). A wide range of variabilities was observed on the pixel-based measures between original and squared videos with the percent deviation ranging from 0.1% to 9.1% with the maximum effect size of 7.43. Conclusions: This research note demonstrates the effect of disregarding PAR to distance and area pixel-based parameters. In addition, we present a multilevel roadmap to prevent possible measurement errors that could occur. At the planning stage, the PAR of video source should be identified, and, at the analyses stage, video data should be prescaled prior to analysis with PAR-unaware software. No methodology in prior absolute or relative pixel-based studies reports adjustment to the PAR prior to measurements nor identify the PAR as a possible source of variation within the literature. Addressing PAR will improve the precision and stability of pixel-based VFSS findings and improve comparability within and across clinical and research settings.

N-of-1 trials, a special case of Single Case Experimental Designs (SCEDs), are prominent in clinical medical research and specifically psychiatry due to the growing significance of precision/personalized medicine. It is imperative that these clinical trials be conducted, and their data analyzed, using the highest standards to guard against threats to validity. This systematic review examined publications of medical N-of-1 trials to examine whether they meet (a) the evidence standards and (b) the criteria for demonstrating evidence of a relation between an independent and an outcome variable per the What Works Clearinghouse (WWC) standards for SCEDs. We also examined the appropriateness of the data analytic techniques in the special context of N-of-1 designs. We searched for empirical journal articles that used N-of-1 design and published between 2013 and 2022 in PubMed and Web of Science. Protocols or methodological papers and studies that did not manipulate a medical condition were excluded. We reviewed 115 articles; 4 (3.48%) articles met all WWC evidence standards. Most (99.1%) failed to report an appropriate design-comparable effect size; neither did they report a confidence/credible interval, and 47.9% reported neither the raw data rendering meta-analysis impossible. Most (83.8%) ignored autocorrelation and did not meet distributional assumptions (65.8%). These methodological problems could lead to significantly inaccurate effect sizes. It is necessary to implement stricter guidelines for the clinical conduct and analyses of medical N-of-1 trials. Reporting neither raw data nor design-comparable effect sizes renders meta-analysis impossible and is antithetical to the spirit of open science.

Network meta-analysis has played an important role in evidence-based medicine for assessing the comparative effectiveness of multiple available treatments. The prediction interval has been one of the standard outputs in recent network meta-analysis as an effective measure that enables simultaneous assessment of uncertainties in treatment effects and heterogeneity among studies. To construct the prediction interval, a large-sample approximating method based on the t-distribution has generally been applied in practice; however, recent studies have shown that similar t-approximation methods for conventional pairwise meta-analyses can substantially underestimate the uncertainty under realistic situations. In this article, we performed simulation studies to assess the validity of the current standard method for network meta-analysis, and we show that its validity can also be violated under realistic situations. To address the invalidity issue, we developed two new methods to construct more accurate prediction intervals through bootstrap and Kenward-Roger-type adjustment. In simulation experiments, the two proposed methods exhibited better coverage performance and generally provided wider prediction intervals than the ordinary t-approximation. We also developed an R package, PINMA (https://cran.r-project.org/web/packages/PINMA/), to perform the proposed methods using simple commands. We illustrate the effectiveness of the proposed methods through applications to two real network meta-analyses.

The Systematic Review Toolbox aims provide a web-based catalogue of tools that support various tasks within the systematic review and wider evidence synthesis process. Identifying publications surrounding specific systematic review tools is currently challenging, leading to a high screening burden for few eligible records. We aimed to develop a search strategy that could be regularly and automatically run to identify eligible records for the SR Toolbox, thus reducing time on task and burden for those involved. We undertook a mapping exercise to identify the PubMed IDs of papers indexed within the SR Toolbox. We then used the Yale MeSH Analyser and Visualisation of Similarities (VOS) Viewer text-mining software to identify the most commonly used MeSH terms and text words within the eligible records. These MeSH terms and text words were combined using Boolean Operators into a search strategy for Ovid MEDLINE. Prior to the mapping exercise and search strategy development, 81 software tools and 55 'Other' tools were included within the SR Toolbox. Since implementation of the search strategy, 146 tools have been added. There has been an increase in tools added to the toolbox since the search was developed and its corresponding auto-alert in MEDLINE was originally set up. Developing a search strategy based on a mapping exercise is an effective way of identifying new tools to support the systematic review process. Further research could be conducted to help prioritise records for screening to reduce reviewer burden further and to adapt the strategy for disciplines beyond healthcare.

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.

Participatory health research (PHR) and the use of arts-based methods continues to grow in popularity. Many scholars acknowledge the importance of (visual) ethics, especially in the dissemination of photographs in a digital age, but ethical issues that arise in relation to contact with the press and social media are not well documented. This article presents second-person action research of a critical case of photovoice in which ethical issues arose when a newspaper report reinforced stigma and was widely disseminated via social media. Press and social media can rapidly engage people for social change, but this also presents risks. What is the potential to de-stigmatize in such situations? The context of the case in this article is the participatory KLIK project, a Dutch initiative which aims to improve the health and resilience of school children aged 8-11 years in a deprived neighbourhood. Awareness of the possibility of political listening and viewing is fundamental for an ethical practice. This article shows the importance of co-ownership, media literacy and collaborative learning about ethics in PHR.

Medical research is important to scientific progress and medical education. Institutions worldwide have sought to increase student involvement in research such as clinician-scientists training programs, while little is known about how medical undergraduates perceive research. A cross-sectional study was conducted in Chongqing Medical University, Chongqing, China, with first--fourth year undergraduates. An online, anonymous, and self-rating 5-point Likert questionnaire was conducted to investigate medical undergraduates' demographic characteristics and assess motivation, self-efficacy, perception, curiosity, and barriers regarding medical research. Content validity was checked with experts and face validity was checked for clarity and understanding of the questionnaire. The Cronbach's alpha coefficient of the questions ranged from 0.813 to 0.879. A total of 3273 medical undergraduates were surveyed, and 86.62% (2835) participants (male 962, female 1873) were identified as effective. Males scored higher than females on self-efficacy (p < 0.001), perception (p = 0.017), and curiosity (p < 0.001), and lower on barriers (p < 0.001). The second year students are at the peak of their perception (p = 0.006) and lowest barrier scores (p = 0.003). Students with scientific research experience scored higher in motivation (p = 0.002), self-efficacy (p < 0.001), perception (p < 0.001), and curiosity (p < 0.001). Lack of proper mentoring opportunity (86.2%) and knowledge (84.5%) were the main barriers in conducting research. Even though they have a positive perspective, only a few undergraduates enrolled in research. Medical universities should encourage faculties to supervise and guide undergraduates' projects, and provide feasible solutions for students to learn scientific knowledge and skills. It is vital to build a research-oriented environment and academic atmosphere.

This article explains the basic ideas and practical challenges in clinical trials of new medicines to show the practical application of statistics in the real-world. The article explores the key considerations for the objectives and design of clinical trials and how these relate to the statistical investigation process. The article also includes examples of practical exercises for students.

Systematic reviewers are advised to search trials registers to minimise risk of reporting biases. However, there has been little research on the impact of searching trials registers on the results of meta-analyses. We aimed to evaluate the impact of searching clinical trials registers for systematic reviews of pharmaceutical or non-pharmaceutical interventions. We searched PubMed, Scopus, Science Citation Index and Social Sciences Citation Index, and Education Collection for systematic reviews with meta-analyses indexed from 2 November to 2 December 2020. A random sample of systematic reviews was initially drawn, and for reviews which considered randomised trials eligible for inclusion, which had not searched a trials register, we searched ClinicalTrials.gov, EudraCT, ANZCTR, and the WHO ICTRP search portal for eligible trials. We compared meta-analytic effect estimates before and after including results from additional trials identified. We found additional trials for 63% (63/101) of eligible reviews; however, trials with results that could contribute to a meta-analysis were identified for only 20% (20/101) of the reviews. On average, there was no difference in the meta-analytic effect estimates before versus after adding the new trials. In summary, searching clinical trial registers led to identification of additional trials for many reviews; however, very few trials had results available for inclusion in meta-analyses. Including results from the new trials led to no change in the meta-analytic estimates, on average. Trials registers would be even more valuable to systematic reviewers if more trialists made use of them (i.e., registered their trials and posted results in a timely manner).

Estimation of within-trial interactions in meta-analysis is crucial for reliable assessment of how treatment effects vary across participant subgroups. However, current methods have various limitations. Patients, clinicians and policy-makers need reliable estimates of treatment effects within specific covariate subgroups, on relative and absolute scales, in order to target treatments appropriately--which estimation of an interaction effect does not in itself provide. Also, the focus has been on covariates with only two subgroups, and may exclude relevant data if only a single subgroup is reported. Therefore, in this article we further develop the "within-trial" framework by providing practical methods to (1) estimate within-trial interactions across two or more subgroups; (2) estimate subgroup-specific ("floating") treatment effects that are compatible with the within-trial interactions and make maximum use of available data; and (3) clearly present this data using novel implementation of forest plots. We described the steps involved and apply the methods to two examples taken from previously published meta-analyses, and demonstrate a straightforward implementation in Stata based upon existing code for multivariate meta-analysis. We discuss how the within-trial framework and plots can be utilised with aggregate (or "published") source data, as well as with individual participant data, to effectively demonstrate how treatment effects differ across participant subgroups.

Frequent language exposure and use are among the most important conditions for successful language learning, whether in classrooms, during study abroad, or in other informal contexts. Research probing exposure and usage often relies on one-off self-report questionnaires in which participants estimate their typical level of language exposure over extended periods of time, often long after it occurred. This may negatively affect the validity of the resulting data. This article instead explores the potential of methods used in medical and psychological research, variably known as the Experience Sampling Method (ESM), Ecological Momentary Assessment (EMA), or diary methods. These methods are often combined with electronic and mobile survey applications to elicit self-report assessments at frequent, sometimes randomized intervals. We consider the possibilities of these methods for strengthening research into language exposure and use, second language acquisition more broadly, and study abroad research specifically. The methods have the potential to drastically reduce biases associated with summative recall. Additionally, they enable researchers to collect richer data about how individuals engage with language differently over time, and the contexts in which they do so, thus ultimately contributing to our understanding of individual differences in language acquisition.

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.

Background: Although cutting-edge chemistry research can be an interesting and motivating context for students in pre-university education, few characteristics of supportive and effective learning materials based on such contexts are available. Purpose: In this study we investigated the design, implementation, and evaluation of context-based learning materials for both teachers and students. Specifically, we studied the characteristics of learning materials situated in the context of cutting-edge chemistry research that are supportive (have educative and usable features) for teachers and effective (have features that foster understanding and motivation) for students. Sample: The designed learning materials were piloted by three teachers in four tenth-grade pre-university chemistry classes at three schools in The Netherlands. Design and methods: The learning materials are shaped by the 5E instructional model and are situated in the context of research on early cancer diagnosis. In this exploratory, small-scale, mixed-methods study, data on teacher and student use of these learning materials were collected through teacher and student group interviews, student pre- and post-tests, and learner self-reports. Results: This study shows that the piloted learning materials have features that are simultaneously supportive for teachers and effective for students. We identified several features that made the materials educative and usable for teachers, and that fostered student understanding and motivation. Conclusion: We conclude that the cutting-edge research context used to situate the learning materials was valuable, and that the teachers in the study were eager to implement these types of materials in their regular practice. In addition, the materials contributed to student motivation and student understanding, and supported teacher learning. This study also describes crucial features that teachers and students valued in the design of the learning materials, which can help in designing other learning materials based on cutting-edge research.

Course-based undergraduate research experiences (CUREs) can engage large numbers of students and provide a structured environment in which to learn valuable research skills. The ability to implement laboratory-based CUREs was hindered by the COVID-19 pandemic, generating a greater need for online options. A pilot study of an adaptation of a fully online cancer genomics CURE is described here. Students utilized freely available databases such as cBioPortal to develop novel scientific questions, generate and analyze data, collaborate with peers, and present their findings in an online environment. This format preserved the defining aspects of CUREs while promoting student ownership over their projects. Although the most common challenge was developing a hypothesis, students valued peer and instructor feedback throughout the process as well as flexible formats for communicating their research findings.

Public research organizations respond to external pressures from national research evaluation systems, performance-based funding systems and university rankings by translating them into internal goals, rules and regulations and by developing organizational identities, profiles and missions. Organizational responses have primarily been studied at the central organizational level, and research on the steering of research has primarily focused on the impacts of performance-based funding systems. However, research evaluation exercises may also have a formative impact, especially below the central organizational level. This paper uses a case study of a research unit of a biomedical research school in the Netherlands to explore the organizational response to a relatively critical external assessment report. It shows that the participation in the Dutch research evaluation cycle legitimated the formation of a new organizational identity for the research unit, which functions as a frame that suggests to staff members a new interpretation of the type of research that is at the core of what the research unit does. We identify three additional steering mechanisms that support the enactment of the organizational identity: steering by resource allocation, by suggesting and by re-organizing. We, furthermore, explore the epistemic effects -- the direction and conduct of research -- of the organizational response, through interview data in combination with a bibliometric analysis.