Achieving the clinical, public health, economic, and policy benefits of translational science requires the integration and application of findings across biomedical, clinical, and behavioral science and health policy, and thus, collaboration across experts in these areas. To do so, translational teams need the skills, knowledge, and attitudes to mitigate challenges and build on strengths of cross-disciplinary collaboration. Though these competencies are not innate to teams, they can be built through the implementation of effective strategies and interventions. The Science of Team Science (SciTS) has contributed robust theories and evidence of empirically-informed strategies and best practices to enhance collaboration. Yet the field lacks methodological approaches to rigorously translate those strategies into evidence-based interventions to improve collaborative translational research. Here, we apply lessons from Implementation Science and Human-Centered Design & Engineering to describe the Wisconsin Interventions in Team Science (WITS) framework, a process for translating established team science strategies into evidence-based interventions to bolster translational team effectiveness. To illustrate our use of WITS, we describe how University of Wisconsin’s Institute for Clinical and Translational Research translated the existing Collaboration Planning framework into a robust, scalable, replicable intervention. We conclude with recommendations for future SciTS research to refine and test the framework.

Objectives/Goals: Since clinical trial participation is a key translational research initiative, the objectiveis to characterize research participants within a health system using electronic health record (EHR) data and evaluate how community-level factors influence research participation rates. Methods/Study Population: Retrospective, cross-sectional study of patients with ICD-10 research encounter codes (Z00.6) from 2016 to 2024 using Rush EHR data organized in the CAPriCORN Common Data Model. Research participation prevalence was the main outcome, calculated by geographic area (3-digit zip codes, Chicago community areas) and linked to Census data for neighborhood factor analysis. Variables include Area Deprivation Index (ADI), Social Vulnerability Index (SVI), education, occupation, and income. The Chi-square test compared demographics and t-tests compared mean SDOH variables between high- and low-participation community areas. Results/Anticipated Results: Of the 1,069,226 patients seen from 2016 to 2024, 11,937 patients had research visits. Of these patients, 45.4% lived in Chicago, 65 years or above is the largest age group (29%), 62% female, 58% White, 82% non-Hispanic, and 9% non-English preferred language. Overall, the research participation prevalence was 1.12%, higher outside of Chicago (1.21%) than within (1.03%). Within Chicago community areas, prevalence ranged from 0.34% to 2.8% (mean: 1.03%, SD: 0.44%). Higher-participating communities (above median) had significantly lower ADI (39.9 vs 61.9), lower SVI (0.51 vs 0.80), lower unemployment (8.0% vs 15.3%), higher bachelor’s degree attainment (43.6% vs 19.6%), higher income ($69,859 vs $36,376), and lower uninsured rates (7.4% vs 11.5%). Discussion/Significance of Impact: This work is the first local exploration of community factors and research participation using curated EHR data. Although limited by single-center data and required entry of EHR codes, it is a step into understanding factors that may influence research participation. Local estimates could be improved by utilizing data from all CAPriCORN sites.

Objectives/Goals: This study aims to gather user feedback from clinical research professionals on the usefulness and relevance of regulatory resources found on a new regulatory web portal, OpenRegSource, to enhance its usability, thereby advancing this project from the initial to the full implementation phase of the implementation science framework. Methods/Study Population: The Regulatory Knowledge and Support core of the Southern California Clinical and Translational Science Institute developed a regulatory web portal called OpenRegSource to help researchers gain basic regulatory information prior to professional and/or paid consultation. Before publicly launching, a virtual focus group (FG) composed of 21 members of the local clinical research workforce was given two weeks to explore the web portal and answer three surveys. Two other research professionals also gave feedback outside of the focus group. The user feedback data was analyzed and discussed by the web portal project team. Updates were then made accordingly. Once the portal was launched, a plan was implemented to collect usage metrics and additional feedback for continuous improvement. Results/Anticipated Results: Of the 21 FG participants, 20 completed the feedback survey specifically for their experience with the web portal. 65% (13/20) said the number of resources was just right. 90% (18/20) found the resources to be very relevant to their respective topics. 85% (17/20) found the resources very useful and somewhat useful to their daily work activities. 75% (15/20) found the organization of the portal to be good or very good. 85% (17/20) found it very easy and somewhat easy to navigate the web portal. 90% (18/20) found the portal to be effective in providing its audience with a basic understanding of regulatory requirements. 95% (19/20) found the portal useful for novice research professionals. 85% (17/20) found the web portal useful overall. Participants were also able to provide commentary feedback for specific pages. Discussion/Significance of Impact: Obtaining stakeholder input during the development of a resource or tool is essential to ensure the final product meets user needs and is effectively utilized. In this case, involving the feedback of clinical researchers will help improve OpenRegSource to better facilitate the advancement of their work.

OBJECTIVES/GOALS: NCATS requires that CTSA-funded pilot projects focus on translational science (TS) and evaluate the translational process. However, a consistent understanding of TS remains elusive. This gap is being addressed by a consortium of 12 CTSA hubs aimed at identifying distinctive features of TS and translational research (TR) proposals. METHODS/STUDY POPULATION: CTSA External Review Exchange Consortium (CEREC) is a reciprocal review collaboration among CTSA hubs. Reviewers were CEREC members from hubs that submitted CTSA applications (PAR-21-293); read the Notice of Funding Opportunity (NOFO) Clinical and Translations Science Pilot Module; and discussed TS with their hubs “a fair amount” or “quite a bit” and then they independently categorized proposals. Proposals were labeled TS or TR if reviewers reached a consensus on category assignment; without consensus, proposals were labeled unclassified. In addition to category assignment, reviewers commented about their classifications. R was used to evaluate the comments and create word clouds with phrases/themes that distinguished between the categories of proposals. RESULTS/ANTICIPATED RESULTS: Twelve CEREC participating hubs submitted 26 proposals, which were funded prior to the new NCATS TS requirements. Eight reviewers from distinct CEREC hubs evaluated and classified each proposal as TS or TR. Consensus (at least 87% agreement) was reached for 12 proposals, 6 TS and 6 TR. Reviewers provided comments describing the rationale for their classifications for 70% of the proposals. Qualitative analysis of the reviewers’ comments and rationale by classification (TS, TR, or unclassified) revealed common themes within and differences between groups and shed light on what defines TS and TR. The most frequent themes that distinguished TS from TR were generalizability across multiple diseases and a focus on increasing research efficiency. DISCUSSION/SIGNIFICANCE: NIH is focused on research that meets the new definition of TS. Investigators seeking to address this funding priority should explicitly state the relevance of their research to multiple diseases and to the acceleration of future research. Programs seeking to attract TS projects should instruct applicants to include this information.

OBJECTIVES/GOALS: CTSA Hubs represent complex centers where teams work to meet multiple goals of the CTSA grant. An existing challenge is to work collaboratively across teams. To address this challenge, a Translational Operations Group (TOG) was established. Results show enhanced intra-hub collaboration and communication while reducing inefficiencies. METHODS/STUDY POPULATION: The TOG is composed of all CTSA hub module program managers who are charged with operationalizing vision into reality. The TOG was formed in 2021 as a mechanism to integrate new team members, provide connection, and improve cross-core awareness and collaboration. Leveraging team science principles, a team charter was developed outlining specific TOG aims and objectives. Collectively, shared goals were identified with establishment of group norms, effective communication pathways, shared resources and knowledge and meeting cadence. Leadership of the group rotates among the TOG members annually further engaging all TOG members. Pre and Post (one year) surveys were developed and provided to TOG members to gauge TOG effectiveness and perceptions of TOG members. RESULTS/ANTICIPATED RESULTS: Survey results demonstrate the effectiveness of the TOG concept in promoting core/module awareness and goals, intra-core/module interconnectedness, and forming connections and integration into the CTSA hub ecosystem. Psycho-social questions demonstrated an increase in organizational self-esteem within the pre to post survey period in relation to the specific TOG member’s core/module and the CTSA hub as a whole. DISCUSSION/SIGNIFICANCE: Formation of a TOG has been successful within a virtual environment where connection is challenging. Integration of members to the operational activities is critical to foster a positive work environment, reduce silo effects, and provide a space for sharing resources and knowledge. Annual reflection of priorities contribute to the ongoing success.

Objectives/Goals: The informed consent (IC) process is similar between clinical trials and expanded access (EA), which allows clinical use of investigational products outside studies. Physicians face unique barriers to IC in clinical environments. This project assesses IC documentation, identifies potential barriers, and evaluates efforts to improve compliance. Methods/Study Population: This is a continuous quality improvement project. To assess the compliance of IC processes for EA patients, informed consent documents signed by EA patients in 2023 were collected and reviewed against institutional standards. Five components of each form were evaluated, and the number and type of noncompliant documentation were tracked. Five physicians who provided EA treatments in 2023 were interviewed and the transcripts were analyzed to identify barriers to physician’s and teams’ IC processes. Efforts made to address these barriers and improve the compliance of informed consent documentation are being tracked and trends in compliance are being evaluated. Results/Anticipated Results: Sixty seven (67) signed informed consent documents for EA treatments were systematically reviewed and 34% were found to be compliant in all key aspects assessed. Analyses of interview notes, transcripts, and memos identified barriers to informed consent processes for expanded access treatments, including the infrequent or irregular occurrence of EA treatments making it difficult for care teams to develop and maintain their understanding of IC process and resources. Efforts made to improve compliance by pre-populating available information into informed consent documentation and removing unnecessary boxes in these forms may have driven improvement in compliance with further efforts underway. Discussion/Significance of Impact: This project evaluated the compliance of IC documentation for EA treatments and identified drivers affecting physicians’ IC processes for these patients. Different strategies to improve the compliance of IC documentation were evaluated and potential best practices for EA support were identified.

Objectives/Goals: Diffusion of innovations (DoI) posits that new health-related ideas spread through communities over time and across stages of adoption. We will apply DoI to understand a paradigm shift toward seeing participants as partners in clinical research, specifically through delivery of plain language summaries of results. Methods/Study Population: The return of results in lay language (plain language) to clinical trial participants represents a paradigm shift in the EU and now the USA. We will conduct a systematic review of the implementation of “lay summaries” or “plain language summaries” in different jurisdictions to understand current regulatory influence. We will then review PLS samples and published studies to determine the rate of adoption by industry and non-pharmaceutical company sponsors. Using the DoI framework, groups will be placed in an adopter category. Finally, we will employ an implementation science approach to understand the diffusion process and the translation to participants, laying the groundwork for a culture of change in medical product development. Results/Anticipated Results: Our search on PubMed using key terms “Diffusion of Innovation” and “Plain Language Summary” did not produce any relevant results in the context of clinical trials in the USA, which illustrates a gap in the literature and application of this theory in this context. In the future analyses, we will examine factors influencing the adoption stage and outcomes, such as regulatory action, what best practices have been defined/implemented (if any), culture shifts in the context of clinical research, health communications, and inclusion of patient voices in clinical research. Our analysis will include a network analysis to evaluate characteristics that influence adoption of PLS in clinical research. We hope to identify who is at the forefront of innovation and why. Discussion/Significance of Impact: Novel application of DoI theory will help lay the groundwork for a culture of change in patient-focused drug development, specifically for the dissemination of results to patients. In future studies, we plan to develop a tailored framework for the inclusion of PLS as part of a paradigm shift in the patient-focused drug development process.

Objectives/Goals: Community-engaged research (CER) emphasizes equitable partnerships between academic and community partners, yet many lack structured training opportunities to develop the necessary knowledge and skills to engage. Recognizing this gap, we launched a co-design process to develop a CER 101 course tailored for both community members and academics. Methods/Study Population: The CER101 design process is rooted in principles of co-design. CAB members, community partners, and academics meet as part of an iterative, interactive, facilitated process to share perspectives, exchange knowledge, and co-create course content. A 2-day workshop began with a process to align visions – define the audience of the course, identify barriers to engagement with the material, and define parameters of the final product. Activities included structured discussions, brainstorming sessions, and feedback cycles. Emphasis is placed on valuing first-hand experience alongside academic expertise to ensure accessibility and relevance. Results/Anticipated Results: The co-design process will produce a CER 101 training that reflects jointly developed foundational concepts, practical strategies for building equitable community–academic partnerships, and case studies highlighting effective CER practices. Participants are expected to demonstrate improved understanding of CER principles, enhanced ability to apply tools for collaboration, and greater appreciation for both lived and academic expertise. The training will strengthen mutual trust, expand shared capacity for CER, and inform iterative refinements to ensure sustained relevance and impact within the community of practice. Discussion/Significance of Impact: In addition to resulting in the development of a CER 101 course that includes foundational concepts and practical strategies for engaging in CER, the co-design process will lead to increased mutual understanding of CER principles, enhanced appreciation for diverse forms of expertise, and strengthen trust.

Routine, nonmedical and ancillary medical costs associated with participation in clinical research create barriers to enrollment for economically disadvantaged individuals. To the extent that race, ethnicity, and gender are linked to SES, such barriers impact efforts to diversify clinical research enrollment. But payment policies and practices often reflect the longstanding and singular concern that payment to participants will bias decision-making and compromise informed consent. We argue that this concern must be viewed in a larger ethical context in which the untoward consequences for the individual participant and for the broader research enterprise are considerable when either inadequate or no payment is provided for expenses incurred (“reimbursement”) and time committed (“compensation”). Fairness in payment and protection from undue influence of payment on the informed consent process are important but distinct ethical considerations. Fundamentally, approaches to payment that leave participants financially worse off as a consequence of taking part in research are inherently unjust as they have a differential impact on recruitment and retention based on socioeconomic status. Sponsors, funders, investigators, and IRBs must be cognizant of the impact of inadequate payment on clinical trial inclusion of historically understudied groups. We address practical and fair payment strategies to advance inclusion, the additional barrier of ancillary medical costs, and potential unintended consequences of payment.

Objectives/Goals: To generate phenotype-specific insights that support tailored prevention strategies and advance precision cardiovascular risk management within Gulf health systems. Methods/Study Population: We analyzed collected primary care records and retained 14,616 complete cases. A composite CV risk index was constructed using a Framingham-based general CVD algorithm from standard clinical variables. “High risk” was defined as the top cohort quartile. Between-group differences were tested with the Kruskal–Wallis test followed by Dunn’s multiple comparisons with Benjamini–Hochberg adjustment. We then modeled (i) the binary high-risk outcome using multivariable logistic regression and (ii) the continuous index using linear regression. Adjusted models included body mass index (BMI), log(ESR + 1), log(CRP + 1), and statin use; variables embedded in the index were not re-adjusted to avoid over-adjustment. Results/Anticipated Results: The proportion above the high-index threshold differed by group: RA 29.4%, no autoimmune 25.7%, multiple-autoimmune 23.9%, SLE 19.8%, and Hashimoto’s 12.7%. The Kruskal–Wallis test was significant (H=68.6, df=4, p<10−13), with Dunn tests (BH-adjusted) showing RA > no autoimmune and SLE, and Hashimoto < all groups. In adjusted logistic regression, odds of high index were higher in RA (OR 1.20, 95% CI 1.06–1.37), lower in Hashimoto (OR 0.49, 95% CI 0.40–0.60), and not clearly different in SLE or multiple-autoimmune. Higher BMI (OR/unit 1.08), ESR (OR/log 1.06), and statin use (OR 4.97) were strongly associated. Discussion/Significance of Impact: In a large primary care cohort, RA showed modestly higher CV risk than non-autoimmune patients after adjustment, while Hashimoto’s showed lower burden. Findings support targeted control of risk factors, especially blood pressure, weight, and inflammation in autoimmune populations.

Objectives/Goals: How do we care for a patient whose mental health is deteriorated such that their decision-making capacity may be compromised? The high-potency opioid crisis in Ontario demands that we provide effective care for the affected population. We must also avoid patients having a subjective experience of coercion and must protect their human rights and dignity. Methods/Study Population: Ontario’s legislation governing mental health care will be explored: the Ontario Mental Health, Healthcare Consent, and Substitute Decisions Acts. We will identify best practices/learning across locales. Patients who have been involuntarily treated/confined will be welcomed to voice what the law should contain. International strategies for: coercion reduction practices, advanced care directives, less prohibitionist care culture, and supports for social determinants of health (SDH) may also help Ontarians. Patients, family members, law enforcement, judiciary, community agencies, and healthcare professionals will be invited to contribute via focus groups to drafted mental health care legislative improvements. Thus, we ensure law enforces patient-defined quality care and practical workflows. Results/Anticipated Results: We hope to emerge from our focus group consultation with draft legislative and procedural edits for Ontario’s mental healthcare laws to ensure that the laws protect human rights and that the laws reflect patient-defined needs. We must ensure controls are in place to de-risk power imbalances and limit the incidence of potential procedural misuse. We intend to design legislated procedures to ensure that people don’t get inappropriately involuntarily confined/treated. We will incorporate the perspectives and lived experiences of patients who have experienced involuntary treatment and/or involuntary medical confinement (locally in a focus group(s)) and internationally (in literature) to inform this legislative development. Discussion/Significance of Impact: We will learn from engaged stakeholders about how to shape Ontario’s legislation to support quality mental health care. We hope to identify and draft legislation improvements that voice what patients and their families’ value, drafts informed by evidence-based best practices and informed innovation. Via inclusion, we create a policy that serves.

OBJECTIVES/GOALS: Health care accounts for an estimated 10% of U.S. greenhouse gas (GHG) emissions. Concerted efforts to decrease waste are needed including critical appraisal of single use items. The purpose of this study was to conduct life cycle analyses (LCA) of a pediatric single use laryngoscope to inform environmental impact and identify targets to reduce waste. METHODS/STUDY POPULATION: LCA was used to quantify the environmental impact of a single use pediatric laryngoscope. LCA is an industry standard measure of energy consumption, water consumption, and GHG emissions encompassing a “cradle-to-grave” assessment. The GREET model (Greenhouse gases, Regulated Emissions and Energy use in Technologies) and Open LCA model were used as sources for product/raw material data. Separate analysis was completed for the battery powering the light emitting diode (LED) lights. RESULTS/ANTICIPATED RESULTS: The LCA revealed 598.2 g of CO2 equivalents for the 121g single use pediatric laryngoscope. There were an estimated 26,849 cases that used single use laryngoscope last year at our free-standing children’s hospital resulting in 16.1 metric tons of CO2 equivalents. This is equivalent to 41,273 miles driven by an average gasoline powered vehicle. The 1.5 V battery was the highest contributor to the laryngoscope’s GHG emissions. While the battery has an estimated 2,800 hours of life, single use laryngoscopes are reported in the literature as being used for only an average of 30 seconds to 2 minutes. DISCUSSION/SIGNIFICANCE: Single use laryngoscopes are high contributors to GHGs. Specifically, the batteries contained in the laryngoscopes are wasteful and challenging to remove and recycle. Future efforts to decrease waste in the OR should target use of similar items that have reusable battery components to improve environmental sustainability.

OBJECTIVES/GOALS: * To analyze and compare disease support (funding, research productivity, drug development) and burden between systemic lupus erythematosus (SLE), which particularly affects Black women, and similar conditions that affect other groups of Americans. * To address the discrepancy of prevalence estimates of SLE in America. METHODS/STUDY POPULATION: This cross-sectional study examined publicly available data on disease funding metrics and research productivity indicators. We utilized the NIH Report database to calculate the total NIH funding and career development awards for SLE from January 1, 2008, to December 31, 2023 (estimated). We reviewed Form 990-T tax returns of SLE organizations to calculate private funding. We examined US-based interventional trials related to SLE on ClinicalTrials.gov between 2008 and 2024, using the terms SLE and lupus. We assessed FDA drug approvals for SLE from 2008 to 2024. We reviewed publicly available SLE disease characteristics such as prevalence, incidence, demographics, costs, and mortality rates. We repeated these methods for conditions like SLE but with different patient demographics. RESULTS/ANTICIPATED RESULTS: We will formulate SLE support based on its avaialble federal and private funding, clinical trials, and drug approvals. We will determine the ratio of SLE support to disease burden and compare it to other conditions that affect different demographics in the US. There is currently a discrepancy in the range of prevalence of SLE in the US (178,362 to 1.5 million), so we will work with specialists to provide a better understanding of the actual prevalence. DISCUSSION/SIGNIFICANCE: SLE is a chronic disorder that is associated with hospitalizations, organ failure, and premature mortality. It has established disparities in incidence, treatment, and outcomes along gender, racial, and socioeconomic lines. Our study highlights the need for policy changes within research funding to address disparities and improve outcomes.

Objectives/Goals: This literature review examines the current landscapes of plain language summaries (PLS), which are used to make research accessible to nonexpert audiences. It aims to identify gaps in their implementation by focusing on challenges related to consistency, accessibility, and quality across fields. Methods/Study Population: A systematic search was conducted using databases such as PubMed and Google Scholar, employing key search terms like “plain language summaries,” “scientific communication,” “health literacy,” “patient education,” “knowledge translation,” “accessibility in research,” “public engagement,” “lay-person,” and “lay summaries.” Literature from multiple sources (pharmaceutical companies/industry, nonprofit organizations, private–public partnerships, and government) was compared to assess the gaps in current PLS best practices. Results/Anticipated Results: Search results yielded 95 articles. Of those, 37 articles fit the criteria, highlighting critical gaps in PLS implementation for clinical research. Preliminary findings suggest a lack of standards and guidelines, as well as a need for more research on the effectiveness of PLS for improving knowledge transfer and patient engagement. Key limitations were identified for investigator-initiated trials (IITs). A best practice table, comparing recommendations from each group of sources, was developed with suggestions for writing effective PLS. While there is consensus on some principles (i.e., importance of simplicity), differences emerge regarding optimal length and the use of layperson glossaries and graphics. The table aims to serve as a guide for creating effective and standardized PLS across fields. Discussion/Significance of Impact: There are limited PLS best practice resources tailored for IITs. These findings could lead to more practical tools and a streamlined approach to enhance communication strategies for lay audiences. This would benefit trial participants and community members who rely on this information and bridge the gap between scientific communities and the public.