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Open science practices such as posting data or code and pre-registering analyses are increasingly prescribed and debated in the applied sciences, but the actual popularity and lifetime usage of these practices remain unknown. This study provides an assessment of attitudes toward, use of, and perceived norms regarding open science practices from a sample of authors published in top-10 (most-cited) journals and PhD students in top-20 ranked North American departments from four major social science disciplines: economics, political science, psychology, and sociology. We observe largely favorable private attitudes toward widespread lifetime usage (meaning that a researcher has used a particular practice at least once) of open science practices. As of 2020, nearly 90% of scholars had ever used at least one such practice. Support for posting data or code online is higher (88% overall support and nearly at the ceiling in some fields) than support for pre-registration (58% overall). With respect to norms, there is evidence that the scholars in our sample appear to underestimate the use of open science practices in their field. We also document that the reported lifetime prevalence of open science practices increased from 49% in 2010 to 87% a decade later.

Pancreatic cancer (PC), one of the most aggressive and life-threatening human malignancies, is known for its resistance to cytotoxic therapies. This is increasingly ascribed to the subpopulation of undifferentiated cells, known as pancreatic cancer stem cells (PCSCs), which display greater evolutionary fitness than other tumor cells to evade the cytotoxic effects of chemotherapy. PCSCs are crucial for tumor relapse as they possess stem cell-like features that are characterized by self-renewal and differentiation. However, the molecular mechanisms that maintain the unique characteristics of PCSCs are poorly understood. Here, we identify the histone methyltransferase KMT2A as a physical binding partner of an RNA polymerase-associated PHF5A-PHF14-HMG20A-RAI1 protein subcomplex and an epigenetic regulator of PCSC properties and functions. Targeting the protein subcomplex in PCSCs with a KMT2A-WDR5 inhibitor attenuates their self-renewal capacity, cell viability, and in vivo tumorigenicity.

Citations play an important role in researchers careers as a key factor in evaluation of scientific impact. Many anecdotes advice authors to exploit this fact and cite prospective reviewers to try obtaining a more positive evaluation for their submission. In this work, we investigate if such a citation bias actually exists: Does the citation of a reviewers own work in a submission cause them to be positively biased towards the submission? In conjunction with the review process of two flagship conferences in machine learning and algorithmic economics, we execute an observational study to test for citation bias in peer review. In our analysis, we carefully account for various confounding factors such as paper quality and reviewer expertise, and apply different modeling techniques to alleviate concerns regarding the model mismatch. Overall, our analysis involves 1,314 papers and 1,717 reviewers and detects citation bias in both venues we consider. In terms of the effect size, by citing a reviewers work, a submission has a non-trivial chance of getting a higher score from the reviewer: an expected increase in the score is approximately 0.23 on a 5-point Likert item. For reference, a one-point increase of a score by a single reviewer improves the position of a submission by 11% on average.

Most older adults reside in low- and middle-income countries (LMICs) but most research dollars spent on interventions to improve the lives of older adults are awarded to researchers in high-income countries (HICs). One approach to improve the implementation of evidence-based innovations for older adults in LMICs is designing interventions that are relevant to LMICs and HICs simultaneously. We propose that researchers in HICs could partner with stakeholders in an LMIC throughout the intervention design process to better position their intervention for the implementation in that LMIC. We provide an example study from an adaptation of the Resources for Enhancing Caregiver Health II in Vietnam, which did not use this strategy but may have benefited from this strategy. We then turn to several considerations that are important for researchers to contemplate when incorporating this strategy. Finally, we explore incentives for creating interventions that are relevant to both HICs and LMICs for funders, intervention designers, and intervention receivers. Although this is not the only strategy to bring interventions to LMICs, it may represent another tool in researchers toolboxes to help expedite the implementation of efficacious interventions in LMICs.

Efficacy of cancer vaccines remains low and mechanistic understanding of antigen presenting cell function in cancer may improve vaccine design and outcomes. Here, we analyze the transcriptomic and immune-metabolic profiles of Dendritic Cells (DCs) from 35 subjects enrolled in a trial of DC vaccines in late-stage melanoma (NCT01622933). Multiple platforms identify metabolism as an important biomarker of DC function and patient overall survival (OS). We demonstrate multiple immune and metabolic gene expression pathway alterations, a functional decrease in OCR/OXPHOS and increase in ECAR/glycolysis in patient vaccines. To dissect molecular mechanisms, we utilize single cell SCENITH functional profiling and show patient clinical outcomes (OS) correlate with DC metabolic profile, and that metabolism is linked to immune phenotype. With single cell metabolic regulome profiling, we show that MCT1 (monocarboxylate transporter-1), a lactate transporter, is increased in patient DCs, as is glucose uptake and lactate secretion. Importantly, pre-vaccination circulating myeloid cells in patients used as precursors for DC vaccine generation are significantly skewed metabolically as are several DC subsets. Together, we demonstrate that the metabolic profile of DC is tightly associated with the immunostimulatory potential of DC vaccines from cancer patients. We link phenotypic and functional metabolic changes to immune signatures that correspond to suppressed DC differentiation.

Thyroid hormones play a pivotal role in diverse physiological processes, and insufficient synthesis of these hormones results in hypothyroidism, a prevalent disorder with a significant global impact. Research has shown that the residual thyroid tissue following surgery fails to fully regenerate the gland and restore normal function. The slow turnover rate of the thyroid gland and the presence of resident stem cells, which may contribute to regeneration within adult thyroid tissue, are topics of ongoing debate. This comprehensive review summarizes current research findings concerning the regeneration of the adult thyroid. Investigations have identified potential cellular mechanisms implicated in thyroid regeneration following partial tissue damage, including cells within microfollicles and a cluster of potential thyroid progenitors cells. Nevertheless, the exact mechanisms remain elusive. In cases of complete removal of the thyroid gland, regeneration does not occur, underscoring the necessity for an external source of thyroid tissue. The transplantation of thyroid organoids has emerged as a promising approach to restore thyroid function. Researchers have successfully derived thyroid organoids from various sources and demonstrated their functionality in both in vitro and in vivo animal models. Despite the challenges that still need to be addressed in achieving full maturation and functionality of human thyroid organoids, significant strides have been made in this regard. This review explores the potential of thyroid organoid transplantation and its implications for the field of regenerative medicine., SCOPUS: re.j, info:eu-repo/semantics/published

Cognitive post-acute sequelae of SARS-CoV-2 (PASC) can occur after mild COVID-19. Detailed clinical characterizations may inform pathogenesis. We evaluated 22 adults reporting cognitive PASC and 10 not reporting cognitive symptoms after mild SARS-CoV-2 infection through structured interviews, neuropsychological testing, and optional cerebrospinal fluid (CSF) evaluations (53%). Delayed onset of cognitive PASC occurred in 43% and associated with younger age. Cognitive PASC participants had a higher number of pre-existing cognitive risk factors (2.5 vs. 0; p = 0.03) and higher proportion with abnormal CSF findings (77% vs. 0%; p = 0.01) versus controls. Cognitive risk factors and immunologic mechanisms may contribute to cognitive PASC pathogenesis.

This special issue of Evaluation and the Health Professions is dedicated to methods for causal mediation analysis in Single Case Experimental Designs (SCEDs). Mediation analysis is used to identify intermediate variables that transmit the effect of the independent variable on the outcome. Until recently, mediation analysis was mostly confined to between-subjects designs and panel studies with few exceptions. Consequently, most of the developments in causal mediation analysis have also been restricted to such designs. In applied health research, SCEDs have been used to evaluate total effects of treatments on outcomes of interest. Providing researchers with the methods for evaluating causal indirect effects for individual participants can lead to important improvements in diagnosis, treatment, and prevention. This special issue includes articles that describe advanced quantitative methods for testing mediators in SCEDs, propose and test approaches that allow for relaxing statistical assumptions that may not hold in real data, and illustrate mediation analysis for a single participant in real and simulated SCEDs data.

The lack of racial diversity among the winners of United States biomedical research prizes reflects a chronic problem of the underappreciation of certain groups of biomedical scientists. Asians continue to be severely underrepresented as awardees of United States biomedical research prizes, a trend that shows no obvious recent improvement.

In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary “consent design toolkit” and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design.

Despite substantial investment and effort by federal agencies and institutions to improve the diversity of the professoriate, progress is excruciatingly slow. One program that aims to enhance faculty diversity is the Institutional Research and Academic Career Development Award (IRACDA) funded by the National Institutes of Health/National Institute of General Medical Sciences. IRACDA supports the training of a diverse cohort of postdoctoral scholars who will seek academic research and teaching careers. The San Diego IRACDA program has trained 109 postdoctoral scholars since its inception in 2003; 59% are women and 63% are underrepresented (UR) Black/African-American, Latinx/Mexican-American, and Indigenous scientists. Sixty-four percent obtained tenure-track faculty positions, including a substantial 32% at research-intensive institutions. However, the COVID-19 pandemic crisis threatens to upend IRACDA efforts to improve faculty diversity, and academia is at risk of losing a generation of diverse, talented scholars. Here, a group of San Diego IRACDA postdoctoral scholars reflects on these issues and discusses recommendations to enhance the retention of UR scientists to avoid a "lost generation" of promising UR faculty scholars.

The lack of racial diversity among the winners of United States biomedical research prizes reflects a chronic problem of the underappreciation of certain groups of biomedical scientists. Asians continue to be severely underrepresented as awardees of United States biomedical research prizes, a trend that shows no obvious recent improvement.

Despite substantial investment and effort by federal agencies and institutions to improve the diversity of the professoriate, progress is excruciatingly slow. One program that aims to enhance faculty diversity is the Institutional Research and Academic Career Development Award (IRACDA) funded by the National Institutes of Health/National Institute of General Medical Sciences. IRACDA supports the training of a diverse cohort of postdoctoral scholars who will seek academic research and teaching careers. The San Diego IRACDA program has trained 109 postdoctoral scholars since its inception in 2003; 59% are women and 63% are underrepresented (UR) Black/African-American, Latinx/Mexican-American, and Indigenous scientists. Sixty-four percent obtained tenure-track faculty positions, including a substantial 32% at research-intensive institutions. However, the COVID-19 pandemic crisis threatens to upend IRACDA efforts to improve faculty diversity, and academia is at risk of losing a generation of diverse, talented scholars. Here, a group of San Diego IRACDA postdoctoral scholars reflects on these issues and discusses recommendations to enhance the retention of UR scientists to avoid a "lost generation" of promising UR faculty scholars.

Cognitive post-acute sequelae of SARS-CoV-2 (PASC) can occur after mild COVID-19. Detailed clinical characterizations may inform pathogenesis. We evaluated 22 adults reporting cognitive PASC and 10 not reporting cognitive symptoms after mild SARS-CoV-2 infection through structured interviews, neuropsychological testing, and optional cerebrospinal fluid (CSF) evaluations (53%). Delayed onset of cognitive PASC occurred in 43% and associated with younger age. Cognitive PASC participants had a higher number of pre-existing cognitive risk factors (2.5 vs. 0; p = 0.03) and higher proportion with abnormal CSF findings (77% vs. 0%; p = 0.01) versus controls. Cognitive risk factors and immunologic mechanisms may contribute to cognitive PASC pathogenesis.

Objectives/hypothesisTo better understand the obstacles facing residents and K-awardee faculty in choosing a clinician-scientist career in otolaryngology.Study designAnonymous survey.MethodsAn anonymous, online Qualtrics survey was sent to residents participating in T32 training grants and K-awardee junior faculty. The survey was sent to the residents with the permission of their program chair. The results of this survey were compiled and analyzed. A separate survey was sent to current K-awardees in U.S. academic programs. Both surveys were then compared to a survey published in 2008 to determine if the concerns and obstacles faced by aspiring clinician-scientists are still present.ResultsResidents felt that combining a research and clinical career presented many obstacles, including a lower salary, competition with PhDs for grant funding, and the lack of departmental support. Prolonging their training to include a fellowship was not a deterrent. Family/spousal issues which ranked as the primary concern previously were no longer given the same level of importance. The major concerns of K-awardees were the economic disparity of clinician-scientists with their clinical counterparts, the lack of mentors, and department support. Forty percent received their K-award after first try, 100% after two revisions, and one has received an R grant funding.ConclusionsThe obstacles facing clinician-scientists in otolaryngology are highlighted by this survey and require attention by our academic programs, National Institutes of Health, and specialty societies.Level of evidenceNA Laryngoscope, 132:1555-1560, 2022.

This cross-sectional study examines the prevalence of restricted choice of treatment in control groups among physicians and investigators conducting oncology randomized clinical trials (RCTs).

This special issue of Evaluation and the Health Professions is dedicated to methods for causal mediation analysis in Single Case Experimental Designs (SCEDs). Mediation analysis is used to identify intermediate variables that transmit the effect of the independent variable on the outcome. Until recently, mediation analysis was mostly confined to between-subjects designs and panel studies with few exceptions. Consequently, most of the developments in causal mediation analysis have also been restricted to such designs. In applied health research, SCEDs have been used to evaluate total effects of treatments on outcomes of interest. Providing researchers with the methods for evaluating causal indirect effects for individual participants can lead to important improvements in diagnosis, treatment, and prevention. This special issue includes articles that describe advanced quantitative methods for testing mediators in SCEDs, propose and test approaches that allow for relaxing statistical assumptions that may not hold in real data, and illustrate mediation analysis for a single participant in real and simulated SCEDs data.

BackgroundOne of the next frontiers in HIV research is focused on finding a cure. A new priority includes people with HIV (PWH) with non-AIDS terminal illnesses who are willing to donate their bodies at the end-of-life (EOL) to advance the search towards an HIV cure. We endeavored to understand perceptions of this research and to identify ethical and practical considerations relevant to implementing it.MethodsWe conducted 20 in-depth interviews and 3 virtual focus groups among four types of key stakeholders in the United States (PWH, biomedical HIV cure researchers, HIV clinicians, and bioethicists) to obtain triangulated viewpoints because little was known about the ethics of this topic. Each group was queried as to ethical considerations, safeguards, and protections for conducting HIV cure-related research at the EOL to ensure this research remains acceptable.ResultsAll four key stakeholder groups generally supported HIV cure-related research conducted at the EOL because of the history of altruism within the PWH community and the potential for substantial scientific knowledge to be gained. Our informants expressed that: (1) Strong stakeholder and community involvement are integral to the ethical and effective implementation, as well as the social acceptability of this research; (2) PWH approaching the EOL should not inherently be considered a vulnerable class and their autonomy must be respected when choosing to participate in HIV cure-related research at the EOL; (3) Greater diversity among study participants, as well as multi-disciplinary research teams, is necessitated by HIV cure-related research at the EOL; (4) The sensitive nature of this research warrants robust oversight to ensure a favorable risk/benefit balance and to minimize the possibility of therapeutic misconception or undue influence; and (5) Research protocols should remain flexible to accommodate participants' comfort and needs at the EOL.ConclusionBecause of the ethical issues presented by HIV c

Leveraging firsthand experience, BRAIN-funded investigators conducting intracranial human neuroscience research propose two fundamental ethical commitments: (1) maintaining the integrity of clinical care and (2) ensuring voluntariness. Principles, practices, and uncertainties related to these commitments are offered for future investigation.

Resilience is often invoked to address systemic marginalization (e.g. racism) in academia but inadvertently maintains harmful systems. We argue that the ability to transform systems, as opposed to persevering within them, must be prioritized to make real, lasting change.

Undergraduate education represents an important transitional stage in which students make career decisions, and undergraduate research experiences (UREs) play a critical role in training the next generation of science, technology, engineering, and mathematics researchers. Extensive studies have identified the different ways in which researchers and graduate students understand their profession, but little work has focused on undergraduate students. To contribute to this gap in literature, this study examines how undergraduate students conceptualize successful researchers. Data were collected using semistructured interviews with transfer students at a research-intensive university, in which participants articulated how they perceive a successful researcher and how their conception had changed based on their undergraduate experiences. Using phenomenography as the research approach, three conceptions of successful researchers were identified based on variations within the following aspects: process of research, interactions with other researchers, and scope of contribution. Retrospective conceptions were more simplistic, with little appreciation for the complex methodological processes and collaborations needed to meaningfully contribute to the research community. After UREs, participants reported conceptions with more nuanced understanding that successful researchers demonstrate proactive engagement, collaboration, and contribution. These findings can be applied to facilitate meaningful research experiences and target undergraduates' professional development as they are enculturated into the research community.

The use of preprints, research manuscripts shared publicly before completing the traditional peer-review process, is becoming a more common practice among life science researchers. Early-career researchers (ECRs) benefit from posting preprints as they are shareable, citable, and prove productivity. However, preprinting a manuscript involves a discussion among all co-authors, and ECRs are often not the decision-makers. Therefore, ECRs may find themselves in situations where they are interested in depositing a preprint but are unsure how to approach their co-authors or advisor about preprinting. Leveraging our own experiences as ECRs, and feedback from the research community, we have constructed a guide for ECRs who are considering preprinting to enable them to take ownership over the process and to raise awareness about preprinting options. We hope that this guide helps ECRs to initiate conversations about preprinting with co-authors and encourage them to preprint their future research.

In evaluation research, "programs" are often conceptualized as clearly bounded, narrow in scope, focused on specific outcomes, using a well-defined linear causal model, and hence, suitable for standard evaluation methods. The evaluation work reported here was carried out in a more challenging context, where large, complex, interwoven systems were targets for change as a means to influence a diffuse array of outcomes. Our evaluation of an NIH-funded program to improve statewide infrastructure for clinical and translational health research ("Advance-CTR") used qualitative data provided by investigators who used the program's services, were funded awardees, or were members of an internal advisory committee (leadership representatives from partnering institutions). We examined perceived barriers to systemic changes to enhance research, as well as how systems have changed due to the Rhode Island Advance-CTR program's efforts, to what degree, and with what effects. Using the causal logic of our program to connect these more distal systemic outcomes to the services and components of Advance-CTR, we discuss the effects this program has had on researchers and their environments, contributing to the development of sustainable programs of research that ultimately improve the health and well-being of our state's residents.

BackgroundPublic health research frequently relies on collaborations with community-based organizations, and these partnerships can be essential to the success of a project. However, while public health ethics and oversight policies have historically focused on ensuring that individual subjects are protected from unethical or unfair practices, there are few guidelines to protect the organizations which facilitate relationships with - and are frequently composed of - these same vulnerable populations. As universities, governments, and donors place a renewed emphasis on the need for community engaged research to address systematic drivers of health inequity, it is vital that the ways in which research is conducted does not uphold the same intersecting systems of gender, race, and class oppression which led to the very same health inequities of interest.MethodsTo understand how traditional notions of public health research ethics might be expanded to encompass partnerships with organizations as well as individuals, we conducted qualitative interviews with 39 staff members (executive directors and frontline) at community-based organizations that primarily serve people who use drugs, Black men who have sex with men, and sex workers across the United States from January 2016 - August 2017. We also conducted 11 in-depth interviews with professional academic researchers with experience partnering with CBOs that serve similar populations. Transcripts were analyzed thematically using emergent codes and a priori codes derived from the Belmont Report.ResultsThe concepts of respect, beneficence, and justice are a starting point for collaboration with CBOs, but participants deepened them beyond traditional regulatory concepts to consider the ethics of relationships, care, and solidarity. These concepts could and should apply to the treatment of organizations that participate in research just as they apply to individual human subjects, although their implementation will differ whe

Both early social psychologists and the modern, interdisciplinary scientific community have advocated for diverse team science. We echo this call and describe three common pitfalls of solo science illustrated by the target article. We discuss how a collaborative and inclusive approach to science can both help researchers avoid these pitfalls and pave the way for more rigorous and relevant research.

AU Special: Pleaseconfirmthatallheadinglevelsarerepresentedcorrectly sessions are important parts of scientific meetings and : conferences: They gather together researchers and students interested in a specific topic and can strongly contribute to the success of the conference itself. Moreover, they can be the first step for trainees and students to the organization of a scientific event. Organizing a special session, however, can be uneasy for beginners and students. Here, we provide ten simple rules to follow to organize a special session at a scientific conference.

In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, abstracts, and if applicable, full publications were screened and coded. The resulting data on fields, models, and themes were then analyzed. We scanned 300 sources from three databases to find 207 uniquely named consent models, and created a network visualization displaying which models occur primarily in one field, and which models overlap between fields. This analysis identifies trends in the consent debate in different fields, as well as common goals of consent models. The most frequently occurring consent models are identified and defined. The analysis contributes toward a cross-disciplinary “consent design toolkit” and highlights that there are more interrelationships between models and fields than are acknowledged in the literature. Where some models are designed to solve distinctively field-specific issues and are specific to biomedical ethics, some may be adaptable and applicable for other fields including engineering and design.

Intracranial electrophysiological research methods, including those applying electrodes on the cortical surface or in deep structures, have become increasingly important in human neuroscience. They also pose novel ethical concerns, as human studies require the participation of neurological patients undergoing surgery for conditions such as epilepsy and Parkinson's disease. Research participants in this setting may be vulnerable to conflicts of interest, therapeutic misconception, and other threats to valid recruitment and consent. We conducted semi-structured interviews with investigators from NIH-funded studies involving recording or stimulation inside the human skull. We elicited perspectives on study recruitment and consent procedures, and analyzed transcripts using a modified grounded theory approach. We interviewed 26 investigators from 19 separate intracranial electrophysiology studies, who described two study types: opportunity studies (n = 15) and experimental trials (n = 4). Respondents described significant heterogeneity in recruitment and consent procedures, even among studies employing similar techniques. In some studies, clinician-investigators were specifically barred from obtaining consent, while in other studies clinician-investigators were specifically required to obtain consent; regulatory guidance was inconsistent. Respondents also described various models for subject selection, the timing of consent, and continuing consent for temporally extended studies. Respondents expressed ethical concerns about participants' vulnerability and the communication of research-related risks. We found a lack of consensus among investigators regarding recruitment and consent methods in human intracranial electrophysiology. This likely reflects the novelty and complexity of such studies and indicates a need for further discussion and development of best practices in this research domain.

BackgroundThe pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research.MethodsWe conducted a scoping review of the growing HIV cure research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing.DiscussionDespite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation).ConclusionHIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly

The COVID-19 pandemic disrupted almost all sectors of academic training and research, but the impact on human immunodeficiency virus (HIV) research mentoring has yet to be documented. We present the perspectives of diverse, experienced mentors in a range of HIV research disciplines on the impact of COVID-19 on mentoring the next generation of HIV researchers.In November to December, 2020, we used an online data collection platform to cross-sectionally query previously-trained HIV mentors on the challenges related to mentoring during the pandemic, surprising/positive aspects of mentoring in that context, and recommendations for other mentors. Data were coded and analyzed following a thematic analysis approach.Respondents (180 of 225 mentors invited [80% response]) reported challenges related to relationship building/maintenance, disruptions in mentees' training and research progress, and mentee and mentor distress, with particular concerns regarding mentees who are parents or from underrepresented minority backgrounds. Positive/surprising aspects included logistical ease of remote mentoring, the relationship-edifying result of the shared pandemic experience, mentee resilience and gratitude, and increased enjoyment of mentoring. Recommendations included practical tips, encouragement for patience and persistence, and prioritizing supporting mentees' and one's own mental well-being.Findings revealed gaps in HIV mentors' competencies, including the effective use of remote mentoring tools, how to work with mentees in times of distress, and the prioritization of mentor well-being. Mentors are in a unique position to identify and potentially address factors that may lead to mentees leaving their fields, especially parents and those from underrepresented backgrounds. We discuss implications beyond the COVID-19 pandemic.

BackgroundAn increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered.MethodsWe used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning.ResultsWe interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research.ConclusionThe increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as th

Fellows and junior faculty conducting aging research have encountered substantial new challenges during the COVID-19 pandemic. They report that they have been uncertain how and whether to modify existing research studies, have faced difficulties with job searches, and have struggled to balance competing pressures including greater clinical obligations and increased responsibilities at home. Many have also wondered if they should shift gears and make COVID-19 the focus of their research. We asked a group of accomplished scientists and mentors to grapple with these concerns and to share their thoughts with readers of this journal.

ObjectiveAlthough women attend medical school and residency at similar rates to men, they experience lower levels of academic career advancement than men. To inform national gender equity efforts, the authors conducted a qualitative study to explore potential gender differences in the career experiences of junior research faculty at a premier research institution.MethodsFocus group discussions were conducted among women and men junior research faculty at the School of Medicine at an urban public research university. Participants were early mentored career development award recipients (K-awardees). Two same-gender focus groups of nine women and six men were conducted. Discussions focused on two domains: barriers to maintaining a research career and facilitators for research career development. Data were analyzed using ATLAS.ti and content analysis methods.ResultsBoth women and men identified a challenging funding environment, difficulty bridging the salary gap, and lack of institutional support as barriers to maintaining their research careers. Women perceived two primary barriers to their career advancement that were different from their male counterparts: They were more likely to feel undervalued at the institution and to experience significant strains related to both childbearing and childcare. Women also reported receiving inadequate mentorship, having poor negotiation skills, and experiencing a lack of negotiation opportunities.ConclusionsAcademic research institutions should consider interventions that provide financial, emotional, and practical support to women research faculty, particularly during their childbearing and childrearing years.

Background: Variations in clinical practice contribute to negative outcomes for children with cancer. Research in this area is imperative to standardise practice, yet such research is challenging to undertake, and a significant proportion of studies fail. A common reason for failure is poor recruitment, yet little information is available to support researchers and clinicians planning such research. Methods: Our primary aim was to describe the recruitment strategies and outcomes in a tertiary children’s hospital across multiple observational supportive care studies. Secondary aims were to establish principles to improve both recruitment strategies and the reporting of recruitment. We undertook a retrospective descriptive analysis of the recruitment logs and data from three studies in pediatric oncology. The mean time to recruit one participant was calculated. Common reasons for not approaching eligible participants and reasons potential participants declined are described. Results: Of the 235 potential candidates across all studies, 186 (79%) were approached and of these 125 (67%) provided consent, with 117 (63%) completing baseline measures. We estimated recruitment per participant required an average 98 min of experienced research nurse time. Four factors are described that influence recruitment and six principles are outlined to maximise recruitment and the generalisability of research findings. Conclusions: We highlight the recruitment experiences across three different projects in children’s cancer supportive care research and provide a roadmap for other researchers planning to undertake clinical research in pediatrics.

COVID-19 has unfortunately halted lab work, conferences, and in-person networking, which is especially detrimental to researchers just starting their labs. Through social media and our reviewer networks, we met some early-career stem cell investigators impacted by the closures. Here, they introduce themselves and their research to our readers.

In celebration of Pride Month, we asked transgender, genderqueer, and nonbinary scientists to tell us about what fascinates them, their ambitions and achievements, and how their gender identities have shaped their experiences in STEM. We owe a special thanks to 500 Queer Scientists (https://500queerscientists.com/), whose network and efforts at increasing LGBTQ+ scientists' visibility made this article possible.

Seit über 30 Jahren informieren Berichte der Gemeinsamen Wissenschaftskonferenz (GWK) bzw. der Bund-Länder-Kommission für Bildungsplanung und Forschungsförderung (BLK) über Chancengleichheit im deutschen Wissenschaftssystem. Die 25. Fortschreibung des Datenmaterials gibt in diesem Jahr Anlass, einen qualifizierten Rückblick auf die Repräsentation der Geschlechter an Hochschulen und außerhochschulischen Forschungseinrichtungen zu werfen. Schlaglichter sollen Erfolge und Stagnation beleuchten, insbesondere mit Blick auf weitere notwendige Schritte auf dem Weg zu mehr Geschlechtergerechtigkeit in der Wissenschaft. Darüber hinaus berücksichtigt der Rückblick für einzelne Bereiche (Studierende, wissenschaftliches Personal, Professuren) die Verknüpfung der Kategorie Geschlecht mit anderen Ungleichheitskategorien wie z.B. sozialer Herkunft. Damit folgt der Bericht Erkenntnissen aus Gleichstellungspraxis und Geschlechterforschung, die besagen, dass Personen gleichen Geschlechts keine homogenen Gruppen darstellen. Dieser Rückblick betrachtet deshalb einzelne Bereiche auch aus intersektionaler Perspektive. Schließlich soll in diesem Rückblick auch thematisiert werden, an welchen Stellen - trotz deutlicher Verbesserung der Datenlagen seit der ersten Publikation - weiterhin Daten fehlen.

BackgroundThe pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research.MethodsWe conducted a scoping review of the growing HIV cure research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing.DiscussionDespite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation).ConclusionHIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly

Despite medical research advancements, inequities persist, as research has enhanced the health of some while leaving many communities untouched. Reforms are needed to direct research toward health equity, both during this pandemic and beyond. All research must currently pass scientific and ethical review processes, but neither may adequately examine a project's potential impact on inequities and local communities. Research stakeholders need practical tools to help review and examine any given study's impact on health equity. We articulate a health equity research impact assessment, which draws from existing research impact assessments and health disparities research measures and frameworks. We describe how this tool was developed and how it may be used by research reviewers, researchers, academic institutions, and funding agencies to elevate health equity in medical science.

The COVID-19 pandemic disrupted almost all sectors of academic training and research, but the impact on human immunodeficiency virus (HIV) research mentoring has yet to be documented. We present the perspectives of diverse, experienced mentors in a range of HIV research disciplines on the impact of COVID-19 on mentoring the next generation of HIV researchers.In November to December, 2020, we used an online data collection platform to cross-sectionally query previously-trained HIV mentors on the challenges related to mentoring during the pandemic, surprising/positive aspects of mentoring in that context, and recommendations for other mentors. Data were coded and analyzed following a thematic analysis approach.Respondents (180 of 225 mentors invited [80% response]) reported challenges related to relationship building/maintenance, disruptions in mentees' training and research progress, and mentee and mentor distress, with particular concerns regarding mentees who are parents or from underrepresented minority backgrounds. Positive/surprising aspects included logistical ease of remote mentoring, the relationship-edifying result of the shared pandemic experience, mentee resilience and gratitude, and increased enjoyment of mentoring. Recommendations included practical tips, encouragement for patience and persistence, and prioritizing supporting mentees' and one's own mental well-being.Findings revealed gaps in HIV mentors' competencies, including the effective use of remote mentoring tools, how to work with mentees in times of distress, and the prioritization of mentor well-being. Mentors are in a unique position to identify and potentially address factors that may lead to mentees leaving their fields, especially parents and those from underrepresented backgrounds. We discuss implications beyond the COVID-19 pandemic.

Preemptive recognition of the ethical implications of study design and algorithm choices in artificial intelligence (AI) research is an important but challenging process. AI applications have begun to transition from a promising future to clinical reality in neurology. As the clinical management of neurology is often concerned with discrete, often unpredictable, and highly consequential events linked to multimodal data streams over long timescales, forthcoming advances in AI have great potential to transform care for patients. However, critical ethical questions have been raised with implementation of the first AI applications in clinical practice. Clearly, AI will have far-reaching potential to promote, but also to endanger, ethical clinical practice. This article employs an anticipatory ethics approach to scrutinize how researchers in neurology can methodically identify ethical ramifications of design choices early in the research and development process, with a goal of preempting unintended consequences that may violate principles of ethical clinical care. First, we discuss the use of a systematic framework for researchers to identify ethical ramifications of various study design and algorithm choices. Second, using epilepsy as a paradigmatic example, anticipatory clinical scenarios that illustrate unintended ethical consequences are discussed, and failure points in each scenario evaluated. Third, we provide practical recommendations for understanding and addressing ethical ramifications early in methods development stages. Awareness of the ethical implications of study design and algorithm choices that may unintentionally enter AI is crucial to ensuring that incorporation of AI into neurology care leads to patient benefit rather than harm.

BackgroundAn increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered.MethodsWe used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning.ResultsWe interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research.ConclusionThe increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as th

Biomedical science and federal funding for scientific research are not immune to the systemic racism that pervades American society. A groundbreaking analysis of NIH grant success revealed in 2011 that grant applications submitted to the National Institutes of Health in the US by African-American or Black Principal Investigators (PIs) are less likely to be funded than applications submitted by white PIs, and efforts to narrow this funding gap have not been successful. A follow-up study in 2019 showed that this has not changed. Here, we review those original reports, as well as the response of the NIH to these issues, which we argue has been inadequate. We also make recommendations on how the NIH can address racial disparities in grant funding and call on scientists to advocate for equity in federal grant funding.

Fellows and junior faculty conducting aging research have encountered substantial new challenges during the COVID-19 pandemic. They report that they have been uncertain how and whether to modify existing research studies, have faced difficulties with job searches, and have struggled to balance competing pressures including greater clinical obligations and increased responsibilities at home. Many have also wondered if they should shift gears and make COVID-19 the focus of their research. We asked a group of accomplished scientists and mentors to grapple with these concerns and to share their thoughts with readers of this journal.

ObjectiveAlthough women attend medical school and residency at similar rates to men, they experience lower levels of academic career advancement than men. To inform national gender equity efforts, the authors conducted a qualitative study to explore potential gender differences in the career experiences of junior research faculty at a premier research institution.MethodsFocus group discussions were conducted among women and men junior research faculty at the School of Medicine at an urban public research university. Participants were early mentored career development award recipients (K-awardees). Two same-gender focus groups of nine women and six men were conducted. Discussions focused on two domains: barriers to maintaining a research career and facilitators for research career development. Data were analyzed using ATLAS.ti and content analysis methods.ResultsBoth women and men identified a challenging funding environment, difficulty bridging the salary gap, and lack of institutional support as barriers to maintaining their research careers. Women perceived two primary barriers to their career advancement that were different from their male counterparts: They were more likely to feel undervalued at the institution and to experience significant strains related to both childbearing and childcare. Women also reported receiving inadequate mentorship, having poor negotiation skills, and experiencing a lack of negotiation opportunities.ConclusionsAcademic research institutions should consider interventions that provide financial, emotional, and practical support to women research faculty, particularly during their childbearing and childrearing years.

Intracranial electrophysiological research methods, including those applying electrodes on the cortical surface or in deep structures, have become increasingly important in human neuroscience. They also pose novel ethical concerns, as human studies require the participation of neurological patients undergoing surgery for conditions such as epilepsy and Parkinson's disease. Research participants in this setting may be vulnerable to conflicts of interest, therapeutic misconception, and other threats to valid recruitment and consent. We conducted semi-structured interviews with investigators from NIH-funded studies involving recording or stimulation inside the human skull. We elicited perspectives on study recruitment and consent procedures, and analyzed transcripts using a modified grounded theory approach. We interviewed 26 investigators from 19 separate intracranial electrophysiology studies, who described two study types: opportunity studies (n = 15) and experimental trials (n = 4). Respondents described significant heterogeneity in recruitment and consent procedures, even among studies employing similar techniques. In some studies, clinician-investigators were specifically barred from obtaining consent, while in other studies clinician-investigators were specifically required to obtain consent; regulatory guidance was inconsistent. Respondents also described various models for subject selection, the timing of consent, and continuing consent for temporally extended studies. Respondents expressed ethical concerns about participants' vulnerability and the communication of research-related risks. We found a lack of consensus among investigators regarding recruitment and consent methods in human intracranial electrophysiology. This likely reflects the novelty and complexity of such studies and indicates a need for further discussion and development of best practices in this research domain.

Our nationwide network of BME women faculty collectively argue that racial funding disparity by the National Institutes of Health (NIH) remains the most insidious barrier to success of Black faculty in our profession. We thus refocus attention on this critical barrier and suggest solutions on how it can be dismantled.

Although it is well documented that adolescents and young adults (AYAs) with cancer have low participation in cancer clinical trials (CCTs), the underlying reasons are not well understood. We used the National Cancer Institute Community Oncology Research Program (NCORP) network to identify barriers and facilitators to AYA CCT enrollment, and strategies to improve enrollment at community-based and minority and/or underserved sites. We performed one-on-one semistructured qualitative interviews with stakeholders (NCORP site principle investigators, NCORP administrators, physicians involved in enrollment, lead clinical research associates or clinical research nurses, nurse navigators, regulatory research associates, patient advocates) in the AYA CCT enrollment process. NCORP sites that included high and low AYA-enrolling affiliate sites and were diverse in geography and department representation (eg, pediatrics, medical oncology) were invited to participate. All interviews were recorded and transcribed. Themes related to barriers and facilitators and strategies to improve enrollment were identified. We conducted 43 interviews across 10 NCORP sites. Eleven barriers and 13 facilitators to AYA enrollment were identified. Main barriers included perceived limited trial availability and eligibility, physician gatekeeping, lack of provider and research staff time, and financial constraints. Main facilitators and strategies to improve AYA enrollment included having a patient screening process, physician endorsement of trials, an "AYA champion" on site, and strong communication between medical and pediatric oncology. Stakeholders identified several opportunities to address barriers contributing to low AYA CCT enrollment at community-based and minority and/or underserved sites. Results of this study will inform development and implementation of targeted interventions to increase AYA CCT enrollment.

Embedded pragmatic clinical trials (ePCTs) and quality improvement (QI) activities often occur simultaneously within healthcare systems (HCSs). Embedded PCTs within HCSs are conducted to test interventions and provide evidence that may impact public health, health system operations, and quality of care. They are larger and more broadly generalizable than QI initiatives, and may generate what is considered high-quality evidence for potential use in care and clinical practice guidelines. QI initiatives often co-occur with ePCTs and address the same high-impact health questions, and this co-occurrence may dilute or confound the ability to detect change as a result of the ePCT intervention. During the design, pilot, and conduct phases of the large-scale NIH Collaboratory Demonstration ePCTs, many QI initiatives occurred at the same time within the HCSs. Although the challenges varied across the projects, some common, generalizable strategies and solutions emerged, and we share these as case studies. KEY LESSONS: Study teams often need to monitor, adapt, and respond to QI during design and the course of the trial. Routine collaboration between ePCT researchers and health systems stakeholders throughout the trial can help ensure research and QI are optimally aligned to support high-quality patient-centered care.