Little guidance exists for developing institutional policies and procedures that support financial management of community-engaged research, including those related to compensating community partners equitably and efficiently for their expertise and time. To address this gap at our institution, the North Carolina Translational and Clinical Sciences Institute at the University of North Carolina at Chapel Hill (UNC) pursued an iterative, multi-pronged approach to identify and address institutional barriers and facilitators related to community partner compensation for research engagement. This case study describes the approach used to involve research administrative leadership, research teams, and community partners at UNC in the identification of institutional barriers to efficient partner compensation. It also elucidates our efforts to develop policies, processes, and resources to address these barriers. The approaches and solutions described can be adapted by other academic research institutions to enhance compensation processes and to facilitate incorporation of community perspectives into the design and implementation of institutional processes that directly impact their engagement in research.

Objectives/Goals: The primary objectives of this project were to create a user-friendly website that • Shares details of ongoing studies in an easily searchable and filterable format. • Provides lay summaries of study results. • Highlights our volunteer registry. • Offers a platform for community engagement and feedback on research interests. Methods/Study Population: The website, developed using DRUPAL 10 and launched in June 2024, was created with input from faculty, staff, research participants, and community partners. It targets potential participants, community members, providers, and other Academic Medical Centers. The development process included focus groups to identify design and feature needs, design iterations and usability testing, and an external accessibility review. Study information is automatically updated from the Study Information Portal (SIP) in OnCore and a custom REDCap survey. Features include a research volunteer registry, study results in lay terms, educational content about research, and multiple ways for community engagement. The site supports English and Spanish and follows best practices for accessibility. Results/Anticipated Results: Community feedback on the site has been very positive, with positive comments about ease of navigation and the improved appearance of the website. It is still early, but we have seen a notable increase in enrollment in the Volunteer Registry since the launch of the website. We track referral sources for the registry, and to date, we have seen 98 individuals enrolled who were directed to us through the website since it launched. This equates to an average of 5 people a week, more than any other referral source. This rate increases to almost 7 per week if we look solely at the period since we started the promotion of the website in early August. As the site awareness expands, we will also be getting feedback from individual studies and are tracking email communication generated from the site as well. Discussion/Significance of Impact: The development of this website represents a significant step toward improving community engagement in clinical research at Duke. By providing a centralized platform for study information, results, and community feedback, we aim to foster a more informed and involved participant base, ultimately enhancing the impact and reach of our research.

Objectives/Goals: This qualitative study evaluated facilitators and barriers to clinical research participation among lower-income, predominately racial/ethnic minority communities to inform a Co-Learning series. The Co-Learning series of community members, stakeholders, and researchers developed strategies to improve diversity in research. Methods/Study Population: Community focus group (FG) participants were recruited from urban communities experiencing poverty, whereas stakeholder FGs included diverse community leaders and researchers. The Social Ecological Model was used as the guiding theoretical framework throughout the qualitative design. Directed content analysis using three independent coders reaching 100% consensus identified prominent factors for increasing diversity in research. The co-learning series was comprised of community members, stakeholders, and researchers who discussed the prominent FG factors over seven in-person meetings to develop a toolkit to increase diversity in research. Results/Anticipated Results: Community (n = 51) and stakeholder (n = 50) FG participants were 54.0±16.0 years of age, 81.2% female, 39.6% Black/African American, 51.5% Hispanic, and 60% had Discussion/Significance of Impact: Due to the lack of inclusivity in clinical research, findings are typically not applicable to health disparity populations limiting the benefit of research to all. This study provides practical community-driven strategies to increase diversity in clinical research, highlighting the role of trust, relationships, and cultural relevancy.

Engaging, accessible, evidence-based interventions are needed to support the professional development of research mentors within the clinical and translational sciences. This article reports on the usage and impact of the University of Minnesota Clinical and Translational Science Institute’s online mentor training module, Optimizing the Practice of Mentoring (OPM). Among the 1,124 OPM users in our contemporary evaluation sample (Feb 2019–June 2022), retrospective pre-to-post gains were observed in respondents’ self-rated mentorship skills (11 items), perceptions of the overall quality of mentoring they provide, and mentoring confidence. A high proportion (83%) of users reported making or intending to make changes in their mentoring practices as a result of the training. Example behavior changes included a greater focus on aligning expectations, more proactive attention to the relationship (overall and its distinct phases), increased usage of active communication skills, adoption of tools such as Individual Development Plans, and ongoing self-reflection. Over a 10-year period, 4,011 unique individuals registered for the module, representing over 650 different institutions (a majority being affiliated with past or current Clinical and Translational Science Hubs). OPM has the versatility to be employed as a standalone, asynchronous approach for mentor development or as one curricular component of more comprehensive, multimodal programs.

Objectives/Goals: This scoping review examines how socioeconomic status (SES) and sociodemographic status (SDS) disparities are considered in transition interventions for congenital heart disease (CHD) patients. By identifying gaps, it aims to guide future research and interventions to address inequities in transitional care. Methods/Study Population: A systematic search of the literature was performed using PubMed, Scopus, and Web of Science. Literature was searched from January 1990 to October 2024 and revealed 823 articles. Upon initial screening, 71 duplicates, 76 non-SES focused articles, and an additional 128 irrelevant articles were excluded. A total of 548 full-text articles were reviewed. Articles that did not focus on transition interventions for CHD patients were excluded. Studies were analyzed for factors affecting care transitions with special attention to SDS and SES factors. SDS factors were defined as age, gender, race/ethnicity, and geographic location, while SES factors were defined as income level, education, employment status, and access to care. Results/Anticipated Results: Out of 548 articles reviewed, only 18 addressed SES factors, and 10 examined SDS factors in the transition from pediatric to adult care. The most common interventions were patient education (33%), care coordination (29%), and family support (21%), but they lacked tailoring to SES/SDS factors. Patients from low-income households were 50% more likely to experience care discontinuities and 40% less likely to participate in transition programs. Health literacy interventions were generic, overlooking socioeconomic differences. Tailored transition programs are needed to address low health literacy and financial barriers, potentially improving outcomes for disadvantaged patients in rural and underserved areas. Discussion/Significance of Impact: This review exposes the limited focus on SES and SDS disparities in CHD transition interventions. Disadvantaged patients face barriers like limited access to care and low health literacy. Developing tailored programs to address these gaps is crucial for enhancing transitions and improving long-term outcomes for vulnerable CHD patients.

Objectives/Goals: Evaluate the effectiveness of ChatGPT as a complementary tool for addressing the mental health needs of Hispanic LGBTTQI+ young adult patients. We will also explore the experience of clinical healthcare providers with the integration of ChatGPT as a complementary tool in psychotherapy with Hispanic LGBTTQI+ young adults. Methods/Study Population: In this mixed-method study, we will create hypothetical clinical cases that reflect common mental health challenges experienced by LGBTTQI+ Hispanic population. These cases will be presented to three groups: 1) ChatGPT app, 2) clinical mental health care providers, and 3) clinical mental health care providers collaborating with ChatGPT. Each group will provide a diagnosis and a treatment plan based on the case information. A panel of experts will evaluate each plan using a standardized rubric to provide a score on clinical accuracy and on the ability to address specific needs of Hispanic LGBTTQI+ patients. Statistical analysis will be used to evaluate the differences in the scores of each domain and qualitative content analysis to evaluate the experience of clinical mental health care providers using ChatGPT. Results/Anticipated Results: The results will provide evidence of the effectiveness of ChatGPT as a supportive tool in mental health care. We anticipated that the combination of a clinical mental health care provider and ChatGPT to develop a diagnosis and treatment plan would produce better outcomes than either ChatGPT or the clinical mental health care provider working independently. We will also expect to find a positive attitude toward the integration of ChatGPT applications, viewing them as useful tools that complement traditional psychological interventions for Hispanic LGBTTQI+ young adults. The study will provide evidence of the effectiveness of ChatGPT to complementing clinical practice involving Hispanic LGBTTQI+ young adults. Those results in a preclinical phase are preconditions to a more applied intervention. Discussion/Significance of Impact: We aim to improve the quality of life for LGBTTQI+ Hispanics by developing innovative psychological treatments enhanced by AI apps. By developing innovative treatments, we are addressing and mitigating health disparities within the LGBTTQI+ Hispanic community in Puerto Rico and contributing to a broader effort of inclusivity and health equity.

Objectives/Goals: The expanding emphasis on translational science necessitates a rethinking of traditional academic formats. To align with the central themes of CTS, we have redesigned our PhD journal club and WIP sessions, introducing novel and innovative approaches that enhance the relevance of these activities to real-world scientific and clinical challenges. Methods/Study Population: The newly adapted journal club format for CTS Predoctoral students at Mayo Clinic maintains the traditional focus on literature review but now incorporates a structured analysis of the clinical implications and potential applications of the research. This innovation aims to foster a deeper understanding of how basic research findings can be translated into improved patient outcomes and healthcare practices. Similarly, the WIP sessions have been restructured to offer an engaging and dynamic learning environment designed to empower clinical and translational science predoctoral students to effectively present their research while emphasizing the challenges they have overcome, demonstrating the translational potential of their findings, and enhancing their communication skills. Results/Anticipated Results: Feedback from participants demonstrates strong support for the new format. Students report a greater engagement with the material and a clearer understanding of how their research can contribute to improving patient outcomes. Discussion/Significance of Impact: These changes accommodate the diverse projects in CTS and embody a commitment to pushing the boundaries of knowledge in CTS. This dual transition marks a significant advancement in preparing PhD students for careers in translational science, ensuring that their research is not only rigorous but also impactful in the real world.

Objectives/Goals: This poster details the development, implementation, and assessment of a comprehensive competency-based curriculum crosswalk and training plan aimed at enhancing the mentorship and skill development of translational research mentees within the National Institutes of Health (NIH) KL2 and TL1 Career Development Award programs. Methods/Study Population: The Center for the Improvement of Mentored Experiences in Research (CIMER) Mentoring Up for Early Career Investigators program, first developed by the University of Wisconsin-Madison, was further adapted by the Frontiers Clinical and Translational Science Institute (Frontiers CTSI). A competency crosswalk illustrates connections between a training curriculum and expected competencies. Developing a competency-based training crosswalk is a strategic approach designed to align mentoring practices with established NIH competencies, including the Seven Characteristics of a Translational Scientist, Mentoring Competency Assessment, Responsible Conduct of Research, Translational Teams, and TeamMAPPS. Results/Anticipated Results: The KL2 and TL1 Award Programs serve as ideal platforms for applying the developed curriculum. Implementing a competency-based, evidence-based, and culturally responsive curriculum for research mentee training has shown substantial benefits. Our pilot tests and full-scale implementation within the KL2 and TL1 Award Programs have demonstrated marked improvements in mentee competencies, such as technical skills, research design, and professional development as shown through evaluation feedback. Integrating the new Frontiers CTSI curriculum has fostered more effective and supportive mentoring relationships. Mentees have reported high satisfaction levels with the training program, particularly appreciating the interactive didactics, continuous feedback mechanisms, and reflective practices. Discussion/Significance of Impact: By adopting these recommendations, Clinical and Translational Science Awards (CTSA) and similar programs can improve research mentorship quality and impact, fostering a diverse cohort of skilled researchers. Implementing these strategies in CTSA mentorship programs offers a model for broader application in research training.

Objectives/Goals: Skilled clinical research professionals are essential to efficient and effective research teams, but many undergraduate students are not aware of staff-level careers in the field. To address this, the Michigan Institute for Clinical and Health Research launched the Clinical and Health Research Professional (CHRP) Pathways Program. Methods/Study Population: The 10-week hybrid CHRP Pathways Program was piloted in Summer 2024. Undergraduate students interested in research careers were recruited from local universities and community colleges. The program consisted of 8 hours/week of didactic curriculum guided by ECRPTQ competencies and 32 hours/week of mentored work experience on research teams. Classroom activities were completed with participants from a partner program within the university. Surveys were administered at 3 weeks and 10 weeks along with an end-of-program focus group to assess acceptability and self-reported learning outcomes. Results/Anticipated Results: The pilot CHRP Pathways Program enrolled 3 students and was well-received by participating students and mentor research teams. Students agreed that they would recommend the program to their classmates. Students indicated that the program helped them understand the role of a study coordinator, provided insight into research career paths, and helped them form professional relationships. Self-reported confidence levels in a range of research competencies increased. Two students who completed the 10-week program chose to continue working part-time with their research teams while continuing their undergraduate studies. Discussion/Significance of Impact: Experiences like the CHRP Pathways Program provide valuable exposure to staff-level research career opportunities for students engaged in health science studies. They can address an existing workforce gap by equipping college graduates with relevant work experience and basic research competencies.

Objectives/Goals: Effective research relies on a well-trained study coordinator workforce, but mentorship programs are lacking. Retaining and empowering career development for skilled research staff is challenging. To address this, the Michigan Institute for Clinical and Health Research launched the STEP.up program. Methods/Study Population: The Staff Enrichment Program for Research Professionals (STEP.up) was created in 2018. To increase knowledge and awareness of our program, we developed an implementation guide to share best practices and open access to our program structure and content. We identified seven critical elements integral to program success. The implementation guide provides a description and rationale for these elements. We partnered with an instructional designer to build a descriptive and easy-to-use guide that describes insights into the successful implementation of the program, practical strategies for program management, and adaptable resources for institutions to use and tailor to their unique needs. Results/Anticipated Results: In the STEP.up program, early career, new-to-role, or new-to-organization research staff members are paired with senior research professionals in a 9-month structured mentorship and career development experience to promote professional development, job satisfaction, and retention for individuals currently working as research professionals. Of the 82 participants from 2018 to 2024, 76 (93%) have remained in their roles as study coordinators. The STEP.up program implementation guide provides the tools, resources, and insights senior research professionals need to implement this program successfully at their sites. Discussion/Significance of Impact: STEP.up program materials are available as an open-source resource on the DIAMOND portal. This resource can encourage others to invest in structured mentorship for research professionals to help establish a culture of growth and cultivate a resilient, skilled, and committed research workforce.

Objectives/Goals: Create a supportive Clinical Research Coordinator (CRC) and Clinical Research Nurse consortium at UF. Facilitate mentorship groups to enhance knowledge on key topics. Build strong professional relationships among members. Empower members through collaboration. Develop future leaders and mentor in clinical research. Methods/Study Population: The CRC Group Mentorship Program at UF’s Gainesville and Jacksonville campuses addresses mentorship needs identified in a recent needs assessment, reflecting strong interest among CRC/CRNs. Small groups are formed using the Group Mentorship and Co-Mentoring Circles models, meeting bimonthly for six months on shared research interests. Co-lead mentors guide learning, peer support, communication skills, and goal setting while tracking progress. Mentees engage in peer learning, skill development, and networking. A dedicated Microsoft Teams platform provides resources to enhance confidence in Joint Task Force Clinical Trial Competencies and fosters collaboration through Q&A sessions, activities, assessments, and meetings, improving real-time and asynchronous interactions. Results/Anticipated Results: To measure mentor program impact, pre- and post-program surveys assess changes in knowledge, skills, and confidence among mentors and mentees, providing insights into effectiveness and areas for improvement. Monthly, the program features two meetings focusing on Joint Task Force competencies: a workshop for all groups on essential mentorship and CRC/CRN competencies, followed by evaluations, quizzes, and continuing education credits. The second meeting is group-specific, led by co-lead mentors, requiring submissions that demonstrate the application of learned knowledge and skills. This structure ensures continuous relevance and quality enhancement in future programs. Discussion/Significance of Impact: The program meets CRCs and CRNs’ critical needs through structured mentorship, fostering a supportive environment. It promotes continuous learning and professional development, enhancing job satisfaction and ensuring the sustainability of valuable research professionals.

Objectives/Goals: To support the growing number of clinical research professionals (CRP) working in behavioral and social science contexts, relevant formative assessments of research skills are needed. This study examines the development of an objective formative assessment designed to assess skills relevant to conducting social and behavioral research. Methods/Study Population: A multidisciplinary group at the University of Michigan was convened to develop the assessment. Case studies depicting clinical and translational research conducted in behavioral and social science contexts were used to measure proficiency in seven of the eight ECRPTQ competencies: Scientific Concepts & Research Design, Ethical & Participant Safety Concerns, Clinical Trial Operations (Good Clinical Practice), Study & Site Management, Data Management & Informatics, Leadership & Professionalism, Communication, and Teamwork & Team Science. Three difficulty levels of questions were developed: basic, intermediate, and advanced. To reinforce knowledge and skill development, the assessment was designed to give respondents formative feedback after responding to each question. Results/Anticipated Results: A preliminary “pre-pilot” test was conducted with three postdoctoral scholars to ensure that the assessment items were understandable. The assessment was then pilot tested with a larger group of 40 clinical research professionals (CRP) to test for the clarity and difficulty level of the items. A smaller group of 20 of these CRPs agreed to participate in focus groups to obtain feedback on their user experience. Data regarding years of experience as a CRP, types of studies engaged with, and information regarding professional certification were collected and used in the analyses. Demographic data collected were not connected to user responses. Results of the pilot test and focus groups were used to revise the questions on the final version of the assessment. Discussion/Significance of Impact: To our knowledge, this is the first objective assessment of research skills for CRP working in behavioral and social science contexts. We will discuss how other institutions can use this instrument to evaluate the training needs of their social and behavioral research workforce.