OBJECTIVES/GOALS: We are using ethnographic methods and Dissemination and Implementation (D&I) frameworks to study barriers and facilitators to implementing ‘TeamMAPPS: Team Methods to Advance Processes and Performance in Science.’ TeamMAPPS is an evidence-based Team Science curriculum deployed as five online modules and being implemented across CTSA hubs. METHODS/STUDY POPULATION: For this pre-implementation study, we used the Implementation Mapping framework to understand likely barriers and facilitators, with the aim of designing implementation strategies and long-term outcome measures. Data included field notes from a two-day train-the-trainer, one visit to a key implementing site, and 27 interviews. Participants were four TeamMAPPS conceptualizers, four module designers, and 15 implementers from seven implementing sites, each with a CTSA hub (four were interviewed twice). We coded transcripts using the Consolidated Framework for Implementation Research (CFIR) to identify contextual barriers and facilitators to D&I, the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) D&I outcomes framework, and target competencies of TeamMAPPS. RESULTS/ANTICIPATED RESULTS: Priority D&I outcomes that emerged were adoption, reach, and effectiveness. Potential barriers/facilitators to “adoption” included institutional willingness to incentivize scientists to utilize TeamMAPPS, support for Team Science at CTSAs, and systems of rewards for scientists to undergo trainings. Anticipated barriers/facilitators for “reach” were closely tied to adoption, such as institutions’ ability to persuade or require scientists to take trainings. Other issues relevant to reach included the time it takes to time to complete TeamMAPPS and potentially fraught intra-team dynamics arising if modules are implemented as a whole-team intervention. Anticipated barriers/facilitators for “effectiveness” included having adequate tools to assess actual impact. DISCUSSION/SIGNIFICANCE: TeamMAPPS has the potential to accelerate advances in translational sciences across the CTSA consortium. As this D&I study proceeds we will continue Implementation Mapping and use the Expert Recommendations for Implementing Change (ERIC) to develop bundles of implementer-informed strategies to the effectively deliver TeamMAPPS among CTSAs.

OBJECTIVES/GOALS: to investigate the potential impact of grandparental factors and multigenerational epigenetic inheritance on the development of ASD METHODS/STUDY POPULATION: Our study recruited participants from the CHARGE (Child Autism Risks from Genetics and the Environment) study, including grandparents, parents, and children. A questionnaire was used to gather information about the participants’ exposure to environmental factors. Saliva samples werecollected from 349 participants. Newborn dried blood spotsfrom probands and parents are still being collected from the California New born Registry. DNA was extracted from 349 saliva samples from 85 families and subjected to whole genome bisulfite sequencing (WGBS) to analyze DNA methylation. Sequence alignments and bioinformatic analyses will be performed using R packages called DMRichR and Comethyl. RESULTS/ANTICIPATED RESULTS: Sequence alignments and bioinformatic analyses are ongoing, utilizing DMRichR to identify individual genomic loci associated with ASD in each of the three generations and Comethyl to compare correlation patterns between methylation marks and selected variables, including grand parental exposures. New born blood spot collections of parents and probands are ongoing and will be used to identify potential ASD epigenomic signatures that are tissue and life-stage independent. DISCUSSION/SIGNIFICANCE: This research will provide new insights into the increased prevalence and underlying etiology of ASD that should pave the way for future research in the field. DNA Methylation signatures can help create molecular biomarkers which can be used together with behavioral clinical tests for diagnosis of ASD.

Educational tools for application of team science competencies in clinical research are needed. Our interdisciplinary group developed and evaluated acceptability of a virtual world game-based learning tool simulating a multisite clinical trial; performance hinges on effective intrateam communication. Initial implementation with clinical research trainees (n=40) indicates high satisfaction and perceived relevance to team science and research career goals. Game-based learning may play an important role in team science training.

Diversity, equity, and inclusion (DEI) are fundamentally important concepts for advancing clinical and translational science (CTS) education. CTS education spans a wide range of disciplines from cell biology to clinical and community/population research. This large scope both in terms of intellectual areas and target groups requires an understanding of existing educational approaches for DEI as we translate DEI from mere concepts into equitable actions within CTS education. In this  review, we provide the readers with the most common DEI educational approaches, including cultural humility, bias training, and improving mentoring to diversify the workforce. DEI educational materials can achieve maximal success and long-term impact when implemented as institutional-wide interventions, and the materials are not seen as an isolated or independent curriculum. Approaches, strategies, and programs to achieve this are many. However, many questions remain unanswered about what the best approach, strategies, and programs are to be implemented in institutional-wide education that will be embedded in CTS education.

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

Diversity remains low among US colleges faculty, with only 3% identifying as Black or Hispanic. Moreover, underrepresented racial minority faculty often face unique challenges and are less likely than their white counterparts to earn higher academic rank, tenure, and funding, especially those who study health equity. We developed a novel program for health-equity focused pre-docs and junior faculty. The Disparities Researchers Equalizing Access for Minorities (DREAM) Scholars is a 24-month career development program led by the Center for Clinical and Translational Science (CCTS) that provides pilot and travel funding, career development seminars, mentoring, and writing retreats. We report the outcomes of the first Scholar cohort (N = 10), pre-docs n = 6; assistant professors, n = 4; seven were Black, one Hispanic, two White, one who identified as non-binary. At the end of the program, Scholars coauthored 34 manuscripts, 9 abstracts and 8 grants. Semi-structured interviews revealed seven major program strengths: funding, support and sense of community, accountability, exposure to translational science, network expansion, and exposure to multidisciplinary peers. Scholars provided feedback useful for subsequent cohorts. The DREAM program provided accountability and fostered a sense of community, expanded professional networks and enhanced scholarly productivity. The program serves as a model for implementation throughout the CCTSs.

NIH offers multiple mentored career development award mechanisms. By building on the UC Davis Clinical and Translational Science Center (CTSC) from its initial NIH funding in 2006, we created an institution-wide K scholar resource. We investigated subsequent NIH funding for K scholars and to what extent CTSC research resources were used. Using NIH RePORTER, we created a database of UC Davis investigators who obtained K01, K08, K23, K25, or K99, as well as institutional KL2 or K12 awards and tracked CTSC research resource use and subsequent funding success. Overall, 94 scholars completed K training between 2007 and 2020, of which 70 participated in one of four institutional, NIH-funded K programs. An additional 103 scholars completed a mentored clinical research training program. Of 94 K awardees, 61 (65%) later achieved NIH funding, with the majority receiving a subsequent individual K award. A higher proportion (73%) of funded scholars used CTSC resources compared to unfunded (48%). Biostatistics and Biomedical Informatics were most commonly used and 55% of scholars used one or more CTSC resource. We conclude that institutional commitment to create a K scholar platform and use of CTSC research resources is associated with high NIH funding rates for early career investigators.

Despite understanding its impact on organizational effectiveness, practical guidance on how to train translational team (TT) leaders is lacking. Previously, we developed an evolutionary learning model of TT maturation consisting of three goal-directed phases: (1). team assembly (Formation); (2). conducting research (Knowledge Generation); and (3). dissemination and implementation (Translation). At each phase, the team acquires group-level knowledge, skills, and attitudes (KSAs) that enhance its performance. Noting that the majority of team-emergent KSAs are promoted by leadership behaviors, we examine the SciTS literature to identify the relevant behaviors for each phase. We propose that effective team leadership evolves from a hierarchical, transformational model early in team Formation to a shared, functional leadership model during Translation. We synthesized an integrated model of TT leadership, mapping a generic “functional leadership” taxonomy to relevant leadership behaviors linked to TT performance, creating an evidence-informed Leadership and Skills Enhancement for Research (LASER) training program. Empirical studies indicate that leadership behaviors are stable across time; to enhance leadership skills, ongoing reflection, evaluation, and practice are needed. We provide a comprehensive multi-level evaluation framework for tracking the growth of TT leadership skills. This work provides a framework for assessing and training relevant leadership behaviors for high-performance TTs.

Community engagement is a critical component of translational research. Innovative educational approaches to support meaningful involvement of stakeholders in clinical research allows for bidirectional learning and greater engagement in translational efforts. Our Penn State Community-Engaged Research Core (CeRC) team has developed an innovative research curriculum for a variety of stakeholders, including patient partners, organizational representatives, and Community Health Workers (CHWs). This brief report will outline unique curricular approaches, guided by adult learning principles, to enhance stakeholder education and engagement in activities. Initial evidence of impact on learning is also reported.

Attacks on minoritized communities and increasing awareness of the societal causes of health disparities have combined to highlight deep systemic inequities. In response, academic health centers have prioritized justice, equity, diversity, and inclusion (JEDI) in their strategic goals. To have a sustained impact, JEDI efforts cannot be siloed; rather, they must be woven into the fabric of our work and systematically assessed to promote meaningful outcomes and accountability. To this end, the University of Pittsburgh’s Institute for Clinical Research Education assembled a task force to create and apply a rubric to identify short and long-term JEDI goals, assess the current state of JEDI at our Institute, and make recommendations for immediate action. To ensure deep buy-in, we gathered input from diverse members of our academic community, who served on targeted subcommittees. We then applied a three-step process to ensure rapid forward progress. We emerged with concrete actions for priority focus and a plan for ongoing assessment of JEDI institutionalization. We believe our process and rubric offer a scalable and adaptable model for other institutions and departments to follow as we work together across academic medical institutions to put our justice, equity, diversity, and inclusion goals into meaningful action.

The NIH National Center for Advancing Translational Science (NCATS) was established to support translational research that spans the entire TS Continuum, with the goal of bridging the gap between preclinical biomedical research and real-world applications to advance treatments to patients more quickly. In 2018, the Translational Science Training (TST) TL1 Program at the University of Texas Health Science Center at San Antonio implemented new strategies to better include and encourage research more broadly across the TS Continuum, including the addition of postdoctoral scientists and a clinically trained Program Co-Director, expansion of team science and community engagement programming, and targeted trainee recruitment from schools of nursing, dentistry, and allied health, in addition to medicine. The objective of this bibliometric analysis was to determine if the program exhibited a more diverse mix of T-types after the adjustments made in 2018. The TST/TL1 Program experienced a shift in T-type, from mostly T0 (preclinical) to more T3/T4 (clinical implementation/public health) research, after new strategies were implemented. This supports the conclusion that strategic programmatic adjustments by an NCATS-funded predoctoral training program resulted in outcomes that better align with NCATS priorities to develop Trainees who contribute across the entire TS Continuum.

The learning sciences have yielded a wealth of insights about the mechanisms and conditions that promote learning, yet the findings from this body of research often do not make their way into educational practice. This fundamentally translational problem is one we believe that educators from translational fields, with their evidence-based orientation and familiarity with the challenges and importance of translation, are well-positioned to address. Here, we provide a primer on the learning sciences to guide educators in the Clinical and Translational Science Institutes and other organizations that train translational researchers. We (a) describe the unique teaching and learning environment in which this training occurs, and why it necessitates attention to learning research and its appropriate application, (b) explain what the learning sciences are, (c) distill the complex science of learning into core principles, (d) situate recent developments in the field within these principles, and (e) explain, in practical terms, how these principles can inform our teaching.

Underrepresented minorities have higher attrition from the professoriate and have experienced greater negative impacts of the COVID-19 pandemic. The purpose of this study was to compare the impact of COVID-19 on the lives of 196 early-career physician-scientists versus PhD researchers who are underrepresented in biomedical research. Participants in the Building Up study answered questions on the impact of the COVID-19 pandemic on their personal and professional lives, and a mixed-methods approach was used to conduct the analysis. While most participants experienced increases in overall stress (72% of PhD researchers vs 76% of physician-scientists), physician-scientists reported that increased clinical demands, research delays, and the potential to expose family members to SARS-CoV-2 caused psychological distress, specifically. PhD researchers, more than physician-scientists, reported increased productivity (27% vs 9%), schedule flexibilities (49% vs 25%), and more quality time with friends and family (40% vs 24%). Future studies should consider assessing the effectiveness of programs addressing COVID-19-related challenges experienced by PhD researchers and physician-scientists, particularly those from underrepresented backgrounds.

Learning Health Systems (LHS) iteratively implement and evaluate health improvement projects. Dissemination and implementation (D&I) science is the study of evidence-based practices in real-world settings, a critical tool for LHS. This paper explores intersections between LHS and D&I science in Clinical and Translational Science Awards (CTSAs) institutions and identifies critical components of collaboration. We conducted website scans of 34 CTSAs and their home institutions that had Dissemination, Implementation, and Knowledge Translation (DIKT) Workgroup members. We identified linkages between CTSAs and their institutions’ LHS. We interviewed six CTSA leaders experienced in LHS and D&I sciences. Nearly half of CTSAs identified an LHS structure on their websites, but only one-third indicates CTSA involvement in these efforts. Interviewees identified key components for successful integration of LHS and D&I sciences: leadership, infrastructure, balance between rigor and efficiency, and aligned incentives. The need for research integration in LHS, to improve evaluation and increase knowledge, is an emerging opportunity for D&I scientists and CTSAs. CTSAs that are engaged in D&I science can introduce and/or expand the role of D&I science in LHS. Collaboration between CTSAs and clinical leaders could result in strengthened relationships between clinical and research enterprises, effective and efficient health care delivery, and improved health.