OBJECTIVES/GOALS: Alachua TranQuility was formed in early 2016 to address needs of transgender people in Alachua County, Florida and surrounding areas. Increasing awareness of gender identity issues created a growing population in need of additional health and social services to counter the negative health outcomes traditionally experienced by transgender people. METHODS/STUDY POPULATION: The group met monthly at UF HealthStreet, a CTSA community engagement program, where social and medical referrals and opportunities to participate in research were made available to attendees. Those attending included transgender and gender non-conforming individuals as well as family, friends and other allies. Outreach was conducted through social media, physical fliers, and tabling at community events. TranQuility partnered with local LGBTQ organizations to promote activities. Leadership was provided by a steering committee that changed over time, with feedback from attendees guiding planning. Simultaneous to TranQuilitys founding, a Youth Gender Clinic was established at UF Health, clearly demonstrating the need for services aimed at the transgender population. RESULTS/ANTICIPATED RESULTS: Between February 2016 and September 2019, attendance at meetings was logged per HealthStreet protocols. Age of attendees ranged from 10 to 75, and most were non-Hispanic whites. More than 300 individuals attended meetings across time, and many attended multiple meetings, with greater than 15% having attended five or more meetings. Attendance averaged around 30+ each month, with a high of 76. Educational programming was offered, such as information on hormone therapy and name/gender marker change, and a parent support group was formed to meet concurrently with the main group. Social opportunities were very popular, as a safe place for people to present as their authentic selves. The coronavirus pandemic curtailed in-person meetings at HealthStreet in 2020, but the group plans to return to this format in 2022. DISCUSSION/SIGNIFICANCE: TranQuility has become an established organization to which other groups provide referrals. Qualitatively it is clear that many people have been positively impacted. An ongoing discussion for the group, however, has been to improve outreach to transgender people of color, who typically suffer from the most discrimination and anti-trans violence.

Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer’s Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.

OBJECTIVES/GOALS: To increase diversity in clinical and translational research (CTR), to strengthen protections for uninsured and under-insured study participants from vulnerable groups by addressing their medical, ancillary care and psycho-social needs and to develop a systematic ethically sound approach to addressing such needs in the study protocol and budget. METHODS/STUDY POPULATION: We conducted) ethical analyses of: (1) the regulatory and ethics scholarship concerning protections and duty of care to research participants from vulnerable groups, and 2) arguments concerning the nature and scope of ancillary care obligations of researchers, as well as 3) a review of the applicable local, federal, and international regulations and practices concerning the duty of care to CTR participants and potential participants who are uninsured, under-insured and/or undocumented members of vulnerable groups. RESULTS/ANTICIPATED RESULTS: Uninsured and underinsured study participants pose major ethical challenges for CTR as medical needs arising during a study are usually covered by the participants own insurance. Lack of health insurance increases vulnerability and creates (1) a barrier to research participation for members of socially disenfranchised groups, (2) risk of discriminatory exclusion of such participants from clinical studies, and (3) inter-institutional inconsistencies in meeting their medical needs; thus limiting diversity in CTR. To address the challenges, we propose an inclusive, systematic, ethically sound approach, which deliberately plans for and provides resources within a study protocol to address the medical and psycho-social needs of uninsured participants during and beyond the study. DISCUSSION/SIGNIFICANCE: Including diverse participants in CTR ensures data quality and social justice. PIs and IRBs should adopt an inclusive approach to the medical needs of vulnerable uninsured participants, plan for their medical and ancillary care needs in the protocol and budget, list community resources, provide follow-up support and note assistance in their files.

Despite the disproportionate burden of Alzheimer’s disease in older adults of color, the scientific community continues to grapple with underrepresentation of racial and ethnic minorities in clinical research. Our Center of Excellence for Alzheimer’s Disease (CEAD) collaborated with a local community partner to conduct community engagement (CE) studios to effectively involve our community of diverse older adults in the early planning stages of a clinical trial. Given the COVID-19 pandemic, the in-person studio format was adapted to allow for virtual, real-time participation. Our objective is to describe the process and feasibility of conducting virtual CE studios in an older adult population. Ninety percent of participants were non-Hispanic Black community-dwelling woman aged 60 years and older. The overall background and proposed clinical trial design was presented to the participants who then made recommendations regarding potential recruitment strategies, the use of culturally relevant language to describe the study, and logistical recommendations to improve participation and retention among community members. Our CEAD successfully conducted virtual CE studios during the COVID-19 pandemic, by partnering with a community-based organization, to engage community stakeholders about clinical trial design. CEADs are in a unique position to implement CE studios to better support patient access to clinical trials.

OBJECTIVES/GOALS: Our goal is three-fold: (1) to enhance protections for research participants in decentralized clinical trials (DCT) by (2) identifying the ethical and regulatory challenges posed by DCT and (3) considering possible solutions to the ethical and regulatory challenges of DCT. METHODS/STUDY POPULATION: A literature review was conducted to identify the ethical and regulatory challenges of DCT. The review showed that, with few exceptions, the publications on DCT have been written by IT experts, researchers or representatives of the pharma industry. There are hardly any independent or multidisciplinary analyses of DCT, e.g., by ethicists, medical sociologists or patients. This suggests that, currently, the potential advantages of digitized clinical research are still to be tested empirically and confirmed independently. Ethical analyses of DCT are particularly scant, which points to a gap in the current understanding of the ethical and regulatory implications of DCT and the issues they raise. Our research used the method of ethical analysis to examine the ethical challenges and to consider possible solutions. RESULTS/ANTICIPATED RESULTS: We identify the following ethical challenges of DCT: (1) challenges related to modifications of research protocols to allow for decentralized activities; (2) lack of expertise for ethical review and approval of digital tools; (3) different regulatory standards of privacy for clinical trials and for commercial digital tools, (4) risks to participants privacy and confidentiality involving both data and physical privacy; (5) the impact of the digital divide on DCT, (6) technology-related subject selection bias and marginalization of vulnerable groups, (7) imposing new burdens on research subjects and caregivers due to technology needs and smaller research teams, (8) restricted access to the study team, and (9) impact of digital technology on informed consent and participant understanding. DISCUSSION/SIGNIFICANCE: DCT became the primary form of clinical research during the COVID-19 pandemic. DCT rely on a wide range of internet-based tools for recruitment, informed consent, data collection, health monitoring, and communication with participants. The tools pose ethical and regulatory challenges, which should be addressed to ensure participant well-being.

OBJECTIVES/GOALS: The Indiana CTSI Strategy Committee charged the Racial Justice and Health Equity Taskforce to identify priorities with short-term and long-term goals consistent with the I-CTSI mission. In addition, I-CTSI leadership asked for a general description of current state and the resources necessary to achieve the proposed goals. METHODS/STUDY POPULATION: The Taskforce applied an inclusive excellence model to the way we look at the I-CTSI structure, policies, and programs while performing an environmental scan within and across I-CTSI partner institutions. In order to reach equitable solutions and consensus, listening tours were held with partner stakeholders guided by the SOAR framework for strategic planning. This approach allowed us to assess current resources, needs, and gaps across the system, along with a baseline of measures currently monitored. Taskforce members openly discussed strengths and opportunities for enhancement of current programs and services. In addition, these conversations offered an opportunity to disrupt existing practices and through collective agency we identified priority areas that promote equity, diversity and inclusion. RESULTS/ANTICIPATED RESULTS: The Taskforce identified recurring themes in conversations with all partners, which led to the formation of three working groups that examined recruitment broadly: workforce, staffing, and research participation; professional development across all stakeholders from community members to I-CTSI staff; and data-centered metrics informing current state, decision-making, and accountability. Recommendations included these priorities, content, and implementation strategies. The Taskforce delivered a report to the I-CTSI leadership fostering the promotion of diversity, equity and inclusion along with a systematic collection of gender, race, and ethnicity data for individuals utilizing I-CTSI services and resources requiring additional metrics and tracking. DISCUSSION/SIGNIFICANCE: The pandemic shed light on the manner in which marginalized groups are rendered particularly vulnerable to death and disease by systemic and structural racism. The I-CTSI recognized that we cannot advance population health without attending to root causes of inequity and that includes our internal structure. We offer a potential model for other CTSAs.

OBJECTIVES/GOALS: The goals of the proposed project are to 1) identify the critical components of trust required by Black Women to build a visible expression of trust within their reproductive health space, and 2) incorporate the elements of trust identified into a mindfulness-based communication tool, for reproductive health care providers. METHODS/STUDY POPULATION: We will be applying a mixed-methods approach inclusive of questionnaires and focus groups. Aim 1: Our study population consists of persons who identify as 18+ Black Women in Alachua County, Florida.Aim 2: Our Population within the reproductive health space (e.g., ob-gyn, midwives, nurse practitioners, etc…) at the University of Florida Shands Hospital. RESULTS/ANTICIPATED RESULTS: We anticipate that our results will fully engage with our Black Women in dialogues about key components of trust they want to experience and have within their reproductive space. This will inform the development of the mindfulness-based tool which will be incorporated with continuous insights with our Black Women. The proposed research project will contribute to the call for health equity. We aim to address this barrier by recognizing the agency of Black women to conceptualize trust on their terms, which we then would incorporate into applied trainings of reproductive health providers to establish trust. Health equity will take a considerable amount of social change at many levels and this study aims to better understand the process. DISCUSSION/SIGNIFICANCE: Structural racism and health disparities are linked with the disproportionate loss of Black women and associated negative birth outcomes. Our work will provide needed insights regarding mistrust in patient-provider relationships. Inform the development of a feasible tool challenging implicit bias in health provider spaces.

As the USA and the rest of the world raced to fight the COVID-19 pandemic, years of investments from the National Center for Advancing Translational Sciences allowed for informatics services and resources at CTSA hubs to play a significant role in addressing the crisis. CTSA hubs partnered with local and regional partners to collect data on the pandemic, provide access to relevant patient data, and produce data dashboards to support decision-making. Coordinated efforts, like the National COVID Cohort Collaborative (N3C), helped to aggregate and harmonize clinical data nationwide. Even with significant informatics investments, some CTSA hubs felt unprepared in their ability to respond to the fast-moving public health crisis. Many hubs were forced to quickly evolve to meet local needs. Informatics teams expanded critical support at their institutions which included an engagement platform for clinical research, COVID-19 awareness and education activities in the community, and COVID-19 data dashboards. Continued investments in informatics resources will aid in ensuring that tools, resources, practices, and policies are aligned to meet local and national public health needs.

OBJECTIVES/GOALS: Many older sepsis survivors develop chronic critical illness (CCI) with poor outcomes. Sepsis is caused by a dysregulated immune response and biomarkers reflecting PICS. The purpose was to compare serial PICS biomarkers in a) older (versus young) adults and b) older CCI (versus older RAP) patients to gain insight into underlying pathobiology of CCI. METHODS/STUDY POPULATION: Prospective longitudinal study with young (≤ 45 years) and older (≥ 65 years) septic adults who were characterized by a) baseline predisposition, b) hospital outcomes, c) serial SOFA organ dysfunction scores over 14 days, d) Zubrod Performance status at three, six and 12-month follow-up and e) mortality over 12 months. Serial blood samples over 14 days were analyzed for selected biomarkers reflecting PICS. RESULTS/ANTICIPATED RESULTS: Compared to the young, more older adults developed CCI (20% vs 42%) and had markedly worse serial SOFA scores, performance status and mortality over 12 months. Additionally, older (versus young) and older CCI (versus older RAP) patients had more persistent aberrations in biomarkers reflecting inflammation, immunosuppression, stress metabolism, lack of anabolism and anti-angiogenesis over 14 days after sepsis. DISCUSSION/SIGNIFICANCE: Older (versus young) and older CCI (versus older RAP) patient subgroups demonstrate early biomarker evidence of the underlying pathobiology of PICS. The population of older sepsis survivors is need of interventions to lower systemic inflammation and stimulate anabolism to prevent skeletal muscle wasting and disability.

OBJECTIVES/GOALS: The overarching objective is to assess the value of promoting team science practices across a diverse clinical translational science community through the development of learning modules. We aim to share lessons learned to help inform best practices for CTSA hubs interested in promoting team science. METHODS/STUDY POPULATION: We recently created a series of self-paced learning modules focused on the science of team science, which include a variety of text and multimedia content. A preliminary assessment was conducted to determine the perceived value of six video team science Learning Shots and to identify areas for improvement. Significant content revisions are underway based on respondent feedback. In early 2022, a follow up survey will solicit feedback from a larger sample of researchers to reassess the learning modules and to ensure that desired improvements were achieved. We will incorporate continuous improvement cycles to gather future feedback, track improvements, and identify potential future direction for new content. RESULTS/ANTICIPATED RESULTS: The preliminary assessment identified the most effective aspects of the modules to be the variety and knowledge of speakers, diversity of topics, organization of the content, and appropriateness of length. Least effective aspects included a desire for more information in some content areas and not enough focus on the challenges of team science for junior faculty. Suggested areas for improvement include a desire for supplemental descriptive text, links to tools that enable teams to be productive, and additional examples from researchers. The follow up study is expected to yield more detailed information on the impacts of the improvements and the overall effectiveness of the modules. DISCUSSION/SIGNIFICANCE: This project provides insights for CTSA Hubs interested in promoting team science and best practices when developing learning modules. Results contribute to what is known about researchers interest in learning about team science and the effectiveness of using online formats for delivery.

Retrospective case studies of initiatives supported by the National Institutes of Health’s Clinical and Translational Science Award (CTSA) hubs can be used to identify facilitators and barriers of translational science. This case study investigates how a CTSA Expanded Access program adapted to changing FDA guidance issued in 2020 to support clinicians’ treatment of COVID-19 patients in Michigan. We studied how this program changed throughout the pandemic to support physicians’ requests for remdesivir, convalescent plasma, and other uses of unapproved drugs and novel medical devices. A protocol for retrospective translational science case studies of health interventions developed by CTSA evaluators was used for this case study. Data collection methods included seven interviews and a review of institutional data, peer-reviewed publications, news stories, and other public records. The barriers identified include evolving guidance, misalignment of organizational operations, and the complexity of the research infrastructure. The facilitators of translation include collaboration between research and care teams, increasing engagement with a broad network of supporters, and ongoing professional development for research staff. The findings of this case study can be used to inform future investigations of the principles underlying the translational process.

OBJECTIVES/GOALS: Diabetes is related to risk for heart disease, stroke, high blood pressure, and COVID-19. It is exacerbated by built/social environment issues, e.g., food insecurity, access to healthy foods and health care, and other poverty-related factors. Our goal is to assess the efficacy of an integrated care model for patients with poorly controlled diabetes. METHODS/STUDY POPULATION: We utilize an integrated, team-based approach to diabetes treatment. In a traditional care model, too little focus is on social determinants and their impacts on health and well-being. Our project involves enrollment of patients with diabetes in an intervention whereby their medical care is integrated with intensive diabetes education and provision of social and other health services, including diet and nutrition, exercise, provision of foods and nutritional supplements, and other support services as needed to achieve optimal health and to reduce morbidity and unnecessary hospitalization and emergency room visits. Subjects are underserved patients treated through our non-profit community clinic partners. We track metrics including individual outcomes, organizational outcomes, and collective impact. RESULTS/ANTICIPATED RESULTS: We anticipate that patients enrolled in this study will demonstrate significant improvements in diabetes control and management. Clinical improvements will include better glycemic control, improved hypertension and dyslipidemia management, reduced complications, and increased preventive measures including foot, eye and oral health exams and monitoring of microalbuminuria. Overall, we anticipate decreased frequency of hospitalizations and readmissions as well as decreased frequency of emergency care visits for treatment of diabetes-related issues. We expect patients to experience enhanced self-efficacy, increased physical activity, and improved quality of life. Their outcomes will be compared to controls receiving the standard medical regimen, matched on age, race, gender, and time of onset. DISCUSSION/SIGNIFICANCE: These activities will improve understanding of factors influencing diabetes outcomes at individual and upstream levels. It will inform food distribution and models of care for improved patient outcomes, including social determinants of health and will establish new protocols for community-based provision of health care to our most vulnerable.

In recent years, there have been concerted efforts to better recruit, support, and retain diverse faculty, staff, and trainees in academic medicine. However, many institutions lack comprehensive and strategic plans to provide support to retain and recruit individuals from historically underrepresented groups. In this article, we itemize specific mechanisms through which institutions can support diverse individuals with the goal of improving inclusion and belonging in the workforce to better reflect the diversity of the intended patient and research participant population.

OBJECTIVES/GOALS: Our primary objective was to determine the demographic and linguistic characteristics of research coordinators (RCs) in a large pediatric emergency medicine research collaborative network. Our secondary objective was to determine if the RCs perceived any impact of those characteristics on their duties. METHODS/STUDY POPULATION: We conducted a 15-question electronic survey of RCs at the member institutions of the Pediatric Emergency Care Applied Research Network (PECARN). A total of 74 potential respondents were identified and received the survey. RESULTS/ANTICIPATED RESULTS: Fifty-three surveys (71.6%) were completed. Most respondents identified as female; white; and not Hispanic or Latino. Fourteen respondents (26.4%) identified as underrepresented minorities in medicine (UIM), which is similar to the percentage of UIM among the general population (30%). Twenty-eight respondents (52%) felt that their race/ethnicity positively impacted recruitment efforts. Twenty-three respondents (43%) felt that their ability to speak a language other than English positively impacted recruitment efforts. Four female respondents felt that their gender hindered their recruitment activities and impacted their sense of belonging within the research team. DISCUSSION/SIGNIFICANCE: RCs felt that their backgrounds and attributes positively impacted subject recruitment. However, some female coordinators felt negatively impacted by their gender. Increasing diversity amongst clinical research professionals and incorporating team cultural humility practices, may help increase diversity among clinical research subjects.

OBJECTIVES/GOALS: The use of Human Centered Design (HCD) to improve the quality of team science is a recent application, and HCDs benefits and challenges have not been rigorously evaluated. We conducted a qualitative study with health sciences researchers trained in HCD methods to determine how they applied HCD methods and perceived its benefits and challenges. METHODS/STUDY POPULATION: The University of Pittsburgh offered HCD training to three cohorts of research scientists (staff as well as faculty) over a three-year period. The training was provided by the LUMA Institute, a premier HCD design firm with a highly regarded training program. We then evaluated this training by conducting 1-hour, semi-structured interviews with trainees from three training cohorts. Interviews focused on perceptions of the training, subsequent uses of HCD, barriers and facilitators, and perceptions of the utility of HCD to science teams. Data analysis was conducted using Braun and Clarkes process for thematic analysis. RESULTS/ANTICIPATED RESULTS: We interviewed 18 researchers (nine faculty and nine staff) trained in HCD methods and identified distinct themes regarding HCD use and its perceived benefits and challenges. Trainees found HCD relevant to research teams for stakeholder engagement, research design, project planning, meeting facilitation, and team management. They also described benefits of HCD in five distinct areas: creativity, egalitarianism, structure, efficiency, and visibility. We also identified challenges, including tensions between HCD approaches and academic culture. DISCUSSION/SIGNIFICANCE: Our data suggest that HCD has the potential to help researchers work more inclusively and collaboratively on interdisciplinary teams and generate more innovative and impactful science. The application of HCD methods is not without challenges; however, we believe these challenges can be overcome with institutional investment.